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EPA-HQ-OECA-2002-0008-0003

Notice

Agency Information Collection Activities; Submission of EPA ICR No. 0649.08 (OMB No. 2060-0106) to OMB for Review and Approval; Comment Request

78455 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices appropriate, it includes the actual data collection instrument. DATES: Comments must be submitted on or before January 23, 2003. ADDRESSES: Send comments, referencing EPA ICR No. 1395.05 and OMB Control No. 2050 0092, to the following addresses: Susan Auby, U. S. Environmental Protection Agency, Collection Strategies Division ( Mail Code 2822T), 1200 Pennsylvania Avenue, NW., Washington, DC 20460 0001; and to Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. FOR FURTHER INFORMATION CONTACT: For a copy of the ICR contact Susan Auby at EPA by phone at ( 202) 566 1672, by e­ Mail at auby. susan@ epa. gov or download off the Internet at http:// www. epa. gov/ icr and refer to EPA ICR No. 1395.05. For technical questions about the ICR, contact Sicy Jacob at EPA by phone at ( 202) 564 8019, by e­ mail at jacob. sicy@ epa. gov. SUPPLEMENTARY INFORMATION: Title: Emergency Planning and Release Notification Requirements under Emergency Planning and Community Right­ to­ Know Act Sections 302, 303, and 304, OMB Control Number 2050 0092, EPA ICR Number 1395.05, expiring January 31, 2003. This is a request for extension of a currently approved collection. Abstract: EPCRA established broad emergency planning and facility reporting requirements. Section 302 ( 40 CFR 355.30) requires facilities where an extremely hazardous substances ( EHS) is present in an amount at or in excess of the threshold planning quantity ( TPQ) to notify the State Emergency Response Commission ( SERC) by May 17, 1987. This activity has been completed; the section 302 costs and burden hours for this ICR, therefore, reflect only the estimate of cost and burden incurred by newly regulated facilities during years 2000 to 2002. Section 303 ( 40 CFR 355.300 requires local emergency planning committees ( LEPCs) to prepare local emergency plans. Facilities subject to section 302 are required to provide information for the development and implementation of these local emergency plans. Section 304 ( 40 CFR 355.40) requires facilities to report to SERCs and LEPCs releases of EHSs and hazardous substances in excess of reportable quantities established by EPA. In addition, these facilities must provide written followup information on the release, its impacts, and any actions taken in response to the release. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. The Federal Register document required under 5 CFR 1320.8( d), soliciting comments on this collection of information was published on August 12, 2002 ( 67 FR 52481); no comments were received. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average for emergency planning under 40 CFR 355.30 is 16.15 hours for new and newly regulated facilities and 1.50 hours for existing facilities. For a limited number of existing facilities, there may be a burden to inform the LEPC of any changes at a facility that may affect emergency planning ( 1.50 hours). The average reporting burden for facilities reporting releases under 40 CFR 355.40 is estimated to average approximately 5 hours per release, including the time for determining if the release is a reportable quantity, notifying the LEPC and SERC, or the 911 operator, and developing and submitting a written follow­ up notice. There are no recordkeeping requirements for facilities under EPCRA sections 302 304. The average burden for emergency planning activities under 40 CFR 300.215 is 21 hours per plan for LEPCs, 16 hours per plan for SERCs. Each SERC and LEPC is also estimated to incur an annual recordkeeping burden of 10 hours. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Facilities where extremely hazardous substances are present, LEPCs and SERCs. Estimated Number of Respondents: 82,260. Frequency of Response: Section 302 respondents will comply with requirements once unless new information becomes available. Section 303 respondents will comply with requirements as requested by LEPCs; LEPCs may have to update their local emergency response plans as new facilities or other information such as new chemicals present at or above a TPQ. Section 304 respondents will comply when there is a release of an EHS above the RQ. Estimated Total Annual Hour Burden: 212,460 hours. Estimated Total Annualized Capital, O& M Cost Burden: $ 15,160. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the addresses listed above. Please refer to EPA ICR No. 1395.05 and OMB Control No. 2050 0092 in any correspondence. Dated: December 10, 2002. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 02 32396 Filed 12 23 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OECA 2002 0008; FRL 7427 1] Agency Information Collection Activities; Submission of EPA ICR No. 0649.08 ( OMB No. 2060 0106) to OMB for Review and Approval; Comment Request AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: NSPS for Metal Furniture Coating subpart EE, OMB Control No. 2060 0106, EPA ICR No. 0649.08, expiration date 1/ 31/ 2003) The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost. DATES: Additional comments may be submitted on or before January 23, 2003. ADDRESSES: Follow the detailed instructions in the SUPPLEMENTARY INFORMATION section. VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78456 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices FOR FURTHER INFORMATION CONTACT: Leonard Lazarus, Compliance and Monitoring Programs Division, Office of Enforcement and Compliance Assurance, 2223 A, ( 202) 564 6369, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 202) 564 6369; fax number: ( 202) 564 0500; e­ mail address: lazarus. leonard@ epa. gov. SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On June 20, 2002 ( 67 FR 41981), EPA sought comments on this ICR pursuant to 5 CFR 1320.8( d). EPA received no comments. EPA has established a public docket for this ICR under Docket ID No. OECA 2002 0008, which is available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the Enforcement and Compliance Docket and Information Center is ( 202) 566 1514. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: ( 1) Submit your comments to EPA online using EDOCKET ( our preferred method), by e­ mail to docket. oeca@ epa. gov, or by mail to: EPA Docket Center, Environmental Protection Agency, Mailcode: 2201T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and ( 2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to http:// www. epa. gov./ edocket. Title: NSPS for Metal Furniture Coating subpart EE ( OMB Control No. 2060 0106, EPA ICR No. 0649.08). This is a request to renew an existing approved collection that is scheduled to expire on January 31, 2003. Under the OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. Abstract: The New Source Performance Standards for Metal Furniture Coating subpart EE were proposed on November 28, 1980 and promulgated on October 29, 1982. These standards apply to each metal furniture surface coating operation in which organic coatings are applied ( greater than 3,842 liters of coating per year), commencing construction, modification or reconstruction after November 28, 1980. Approximately three hundred ninety­ seven ( 397) sources are currently subject to the regulation, and it is estimated that an additional thirty ( 30) sources per year will become subject to the regulation in the next three years while an equal number will go off­ line during this time period. This information is being collected to assure compliance with 40 CFR part 60, subpart EE. Owners or operators of the affected facilities described must make initial reports when a source becomes subject, conduct and report on a performance test, demonstrate and report on continuous monitor performance, and maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility. Semiannual reports of excess emissions are required. These notifications, reports, and records are essential in determining compliance; and are required, in general, of all sources subject to NSPS. Any owner or operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least 2 years following the date of such measurements, maintenance reports, and records. The estimated total cost of this ICR will be $ 836,540 per year over the next three years. All reports are sent to the delegated State or Local authority. In the event that there is no such delegated authority, the reports are sent directly to the EPA Regional Office. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 71 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Owners/ Operators of metal furniture coating facilities. Estimated Number of Respondents: 397. Frequency of Response: semiannual for all, every other year for excess emission report. Estimated Total Annual Hour Burden: 73,181 hours. Estimated Total Annual Cost: $ 5,016,640, includes $ 4,180,100 labor costs and $ 836,540 non­ labor costs. Changes in the Estimates: There is a decrease of 27,889 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This decrease is due to a correction in the number of facilities based on a review of records incorporated into EPA's Integrated Data VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78457 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices for Enforcement Analysis ( IDEA) database. Dated: December 10, 2002. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 02 32397 Filed 12 23 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OECA 2002 0006; FRL 7427 2] Agency Information Collection Activities: Submission of EPA ICR No. 1130.07 ( OMB No. 2060 0082) to OMB for Review and Approval; Comment Request AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: NSPS for Grain Elevators subpart DD, OMB Control No. 2060 0082, EPA ICR No. 1130.07, expiration date January 31, 2003. The ICR, which is abstracted below describes the nature of the information collection and its expected burden and cost. DATES: Additional Comments must be submitted on or before January 23, 2003. ADDRESSES: Follow the detailed instructions in the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Kenneth R. Harmon, Compliance Assistance and Sector Programs Division, Office of Compliance, 2224A, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 202) 564 7049; fax number: ( 202) 564 7083; e­ mail address: harmon. kenneth @ epa. gov. Refer to EPA ICR Number 1130.07. SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On June 20, 2002 ( 67 FR 41981), EPA sought comments on this ICR pursuant to 5 CFR 1320.8( d). EPA received no comments. EPA has established a public docket for this ICR under Docket ID No. OECA 2002 0006, which is available for public viewing at the Enforcement and Compliance Docket and Information Center ( EDIC) Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number of the EDIC is ( 202) 566 1514. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: ( 1) Submit your comments to EPA online using EDOCKET ( our preferred method), by e­ mail to docket. oeca@ epa. gov, or by mail to: EPA Docket Center, Environmental Protection Agency, Mailcode: 2201T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and ( 2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to http:// www. epa. gov./ edocket. Title: NSPS Grain Elevators subpart DD ( OMB Control No. 2060 0082; EPA ICR No. 1130.07). This is a request to renew a collection that is scheduled to expire on January 31, 2003. Under the Paperwork Reduction Act, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. Abstract: This ICR contains recordkeeping and reporting requirements that are mandatory for compliance with 40 CFR 60.300, et seq., subpart DD, New Source Performance Standards for Grain Elevators. This information notifies EPA when a source becomes subject to the regulations, informs the Agency if a source is in compliance. In the Administrator's judgment, particulate matter emissions from grain elevators cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, NSPS were promulgated for this source category, as required under section 111 of the Clean Air Act. Controlling emissions of particulate matter from grain elevators requires not only the installation of properly designed equipment, but also the operation and maintenance of that equipment. Particulate emissions from grain elevators are the result of grain drying and grain handling operations, including loading and unloading. These standards rely on the proper operation of particulate control devices such as baghouses and equipment such as shed doors and spouts designed to reduce particulate emission during grain unloading and loading. Owners or operators of the affected facilities subject to NSPS subpart DD must make the following one­ time­ only reports: notification of the date of construction or reconstruction; notification of the anticipated and actual dates of startup; notification of any physical or operational change to an existing facility that may increase the rate of emission of the regulated pollutant; notification of the date of the initial performance test; and the results of the initial performance test, including information necessary to determine the conditions of the performance test and performance test measurements and results, including particulate matter concentration and opacity. Owners or operators are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, as well as the nature and cause of the malfunction ( if known) and corrective measures taken. These notifications, reports and records are required, in general, of all sources subject to NSPS. Without such information, enforcement personnel VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1

epa

2024-06-07T20:31:41.078907

regulations

EPA-HQ-OECA-2002-0009-0003

Notice

Agency Information Collection Activities; Submission of EPA ICR No. 1899.02 (OMB No. 2060-0422 to OMB for Review and Approval; Comment Request

78449 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices ENVIRONMENTAL PROTECTION AGENCY [ OECA 2002 0009; FRL 7426 3] Agency Information Collection Activities; Submission of EPA ICR No. 1899.02 ( OMB No. 2060 0422 to OMB for Review and Approval; Comment Request AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: Emission Guidelines for Hospital/ Medical/ Infectious Waste Incinerators ( OMB Control No. 2060 0422, EPA ICR No. 1899.02) The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost. DATES: Additional comments may be submitted on or before January 23, 2003. ADDRESSES: Follow the detailed instructions in the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Jonathan Binder, Compliance Assistance and Sector Programs Division, Office of Compliance, Mail Code 2224A, 202 564 2516 Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202 564 2516; fax number: 202 564 0009; e­ mail address: binder. jonathan@ epa. gov. SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On June 20, 2002 ( 67 FR 41981), EPA sought comments on this ICR pursuant to 5 CFR 1320.8( d). EPA received no comments. EPA has established a public docket for this ICR under Docket ID Number OECA 2002 0009, which is available for public viewing at the Enforcement and Compliance Docket and Information Center ( ECDIC) Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding federal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the Enforcement and Compliance Docket and Information Center ( ECDIC) Docket is ( 202) 566 1514. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket identification number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: ( 1) Submit your comments to EPA online using EDOCKET ( our preferred method), by e­ mail to docket. oeca@ epa. gov, or by mail to: EPA Docket Center, Environmental Protection Agency, Mailcode: 2201T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and ( 2) mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, confidential business information ( CBI), or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to http:// www. epa. gov/ edocket. Title: Emission Guidelines for Hospital/ Medical/ Infectious Waste Incinerators ( 40 CFR part 60, subpart Ce) ( OMB Control No. 2060 0422, EPA ICR Number 1899.02). This is a request to renew an existing approved collection that is scheduled to expire on January 31, 2003. Under the OMB regulations, EPA may continue to conduct or sponsor the collection of information while this submission is pending at OMB. Abstract: Hospital/ Medical/ Infectious Waste Incinerators ( HMIWI) for which construction was commenced on or before June 20, 1996, and burning hospital waste and/ or medical infectious waste are subject to specific reporting and recording keeping requirements. Notification reports are required related to the construction, reconstruction, or modification of an HMIWI. Also required are one­ time­ only reports related to initial performance test data and continuous measurements of site­ specific operating parameters. Annual compliance reports are required related to a variety of site­ specific operating parameters, including exceedances of applicable limits. Semiannual compliance reports are required related to emission rate or operating parameter data that were not obtained when exceedances of applicable limits occurred. Affected entities must retain records for five years the reports and records that are required under 40 CFR part 60, subpart Ce, General Provisions. Co­ fired combustors and incinerators burning only pathological, low­ level radioactive, and/ or chemotherapeutic waste are required to submit notification reports of an exemption claim, and an estimate of the relative amounts of waste and fuels to be combusted. Cofired combustors and incinerators are also required to maintain records on a calendar quarter basis of the weight of hospital waste combusted, the weight of medical/ infectious waste combusted, and the weight of all other fuels combusted at the co­ fired combustor. Incinerators burning only pathological, low­ level radioactive, and/ or chemotherapeutic waste are also required to maintain records of the periods of time when only pathological waste, low­ level radioactive waste, and/ or chemotherapeutic waste is burned. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 163 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78450 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Owners and Operators of Hospital/ Medical/ Infectious Waste Incinerators. Estimated Number of Respondents: 189. Frequency of Response: On occasion, semi­ annually, and annually. Estimated Total Annual Hour Burden: 105,228. Estimated Total Annual O& M Cost: $ 295,407, includes O& M costs. Changes in the Estimates: There is a decrease of 28,176 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This decrease is due to a reduction in the number of affected respondents as indicted by a recent source inventory analysis. Dated: December 10, 2002. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 02 32390 Filed 12 23 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OECA 2002 0010; FRL 7426 4] Agency Information Collection Activities; Submission of EPA ICR No. 0111.10 ( OMB No. 2060 0101) to OMB for Review and Approval; Comment Request AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: NESHAP for Asbestos, 40 CFR part 61, subpart M ( OMB Control No. 2060 0101, EPA ICR No. 0111.10), expiration date February 28, 2003. The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost. DATES: Additional comments may be submitted on or before January 23, 2003. ADDRESSES: Follow the detailed instructions in the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Everett Bishop, Compliance Assurance and Media Programs Division, Office of Compliance, 2223A, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 202) 564 7032, fax number: ( 202) 564 0050; e­ mail address: bishop. everett@ epa. gov. SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On June 20, 2002 ( 67 FR 41981), EPA sought comments on this ICR pursuant to 5 CFR 1320.8( d). EPA received no comments. EPA has established a public docket for this ICR under Docket ID No. OECA 2002 0010, which is available for public viewing at the Enforcement and Compliance Docket and Information Center ( ECDIC) in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the ECDIC is ( 202) 566 1514. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: ( 1) Submit your comments to EPA online using EDOCKET ( our preferred method), by e­ mail to: docket. oeca@ epa. gov, or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code: 2201T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and ( 2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to http:// www. epa. gov/ edocket. Title: NESHAP for Asbestos, 40 CFR part 61, subpart M, ( OMB Control No. 2060 0101, EPA ICR Number 0111.10). This is a request to renew an existing approved collection that is scheduled to expire on February 28, 2003. Under the OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. Abstract: The EPA is charged under section 112 of the Clean Air Act, as amended, to establish standards of performance for each category or subcategory of major sources and area sources of hazardous air pollutants. These standards are applicable to new or existing sources of hazardous air pollutants and shall require the maximum degree of emission reduction: In addition, section 114( a) States that: * * * The Administrator may require any owner or operator subject to any requirement of this Act to ( A) establish and maintain such records, ( B) make such reports, ( C) install, use, and maintain such monitoring equipment or methods ( in accordance with such methods at such locations, at such intervals, and in such manner as the Administrator shall prescribe), and ( D) sample such emissions, ( E) keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical, ( F) submit compliance certifications, and ( G) provide such other information as he may reasonably require. In the Administrator's judgment, asbestos emissions from the demolition and renovation of asbestos­ containing structures; the disposal of asbestos waste; waste conversion; asbestos milling, manufacturing, and fabricating; the use of asbestos on roadways; the use VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1

epa

2024-06-07T20:31:41.086315

regulations

EPA-HQ-OECA-2002-0010-0003

Notice

Agency Information Collection Activities; Submission of EPA ICR No. 0111.10 (OMB No. 2060-0101) to OMB for Review and Approval; Comment Request

78450 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Owners and Operators of Hospital/ Medical/ Infectious Waste Incinerators. Estimated Number of Respondents: 189. Frequency of Response: On occasion, semi­ annually, and annually. Estimated Total Annual Hour Burden: 105,228. Estimated Total Annual O& M Cost: $ 295,407, includes O& M costs. Changes in the Estimates: There is a decrease of 28,176 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This decrease is due to a reduction in the number of affected respondents as indicted by a recent source inventory analysis. Dated: December 10, 2002. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 02 32390 Filed 12 23 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OECA 2002 0010; FRL 7426 4] Agency Information Collection Activities; Submission of EPA ICR No. 0111.10 ( OMB No. 2060 0101) to OMB for Review and Approval; Comment Request AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: NESHAP for Asbestos, 40 CFR part 61, subpart M ( OMB Control No. 2060 0101, EPA ICR No. 0111.10), expiration date February 28, 2003. The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost. DATES: Additional comments may be submitted on or before January 23, 2003. ADDRESSES: Follow the detailed instructions in the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Everett Bishop, Compliance Assurance and Media Programs Division, Office of Compliance, 2223A, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 202) 564 7032, fax number: ( 202) 564 0050; e­ mail address: bishop. everett@ epa. gov. SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On June 20, 2002 ( 67 FR 41981), EPA sought comments on this ICR pursuant to 5 CFR 1320.8( d). EPA received no comments. EPA has established a public docket for this ICR under Docket ID No. OECA 2002 0010, which is available for public viewing at the Enforcement and Compliance Docket and Information Center ( ECDIC) in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the ECDIC is ( 202) 566 1514. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: ( 1) Submit your comments to EPA online using EDOCKET ( our preferred method), by e­ mail to: docket. oeca@ epa. gov, or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code: 2201T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and ( 2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to http:// www. epa. gov/ edocket. Title: NESHAP for Asbestos, 40 CFR part 61, subpart M, ( OMB Control No. 2060 0101, EPA ICR Number 0111.10). This is a request to renew an existing approved collection that is scheduled to expire on February 28, 2003. Under the OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. Abstract: The EPA is charged under section 112 of the Clean Air Act, as amended, to establish standards of performance for each category or subcategory of major sources and area sources of hazardous air pollutants. These standards are applicable to new or existing sources of hazardous air pollutants and shall require the maximum degree of emission reduction: In addition, section 114( a) States that: * * * The Administrator may require any owner or operator subject to any requirement of this Act to ( A) establish and maintain such records, ( B) make such reports, ( C) install, use, and maintain such monitoring equipment or methods ( in accordance with such methods at such locations, at such intervals, and in such manner as the Administrator shall prescribe), and ( D) sample such emissions, ( E) keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical, ( F) submit compliance certifications, and ( G) provide such other information as he may reasonably require. In the Administrator's judgment, asbestos emissions from the demolition and renovation of asbestos­ containing structures; the disposal of asbestos waste; waste conversion; asbestos milling, manufacturing, and fabricating; the use of asbestos on roadways; the use VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78451 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices of asbestos insulation and spray materials; cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, NESHAP was promulgated for this source category at 40 CFR part 61, subpart M. The control of emissions of asbestos from the regulated sources requires not only the installation of properly designed equipment, but also the operation and maintenance of that equipment. Emissions of asbestos from the regulated sources are the result of operation of those sources ( milling, manufacturing, fabricating, waste disposal, and demolition and renovation). These standards rely on the capture and reduction of asbestos emissions by air cleaning equipment and specified work practices. The required notifications are used to inform the Agency or delegated authority when a source becomes subject to the standard. The reviewing authority may then inspect the source to check if the pollution control devices are properly installed and operated, the work practices are being followed and the standard is being met. Performance test reports are needed as these are the Agency's record of a source's initial capability to comply with the emission standard, and serve as a record of the operating conditions under which compliance was achieved. Thereafter, submission of semi­ annual reports of any visible emissions serves as the record of compliance. Waste conversion facilities must report initial testing conditions that become normal operating conditions for the plant. The quarterly reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations. Notification for each demolition or renovation activity allows the Agency or delegated authority to plan for inspections of the source in order to determine compliance with the work practices. Since each demolition or renovation is transitory in nature, notification must be made for each activity above the threshold limits specified in the regulation. The information generated by the monitoring, recordkeeping and reporting requirements described in this ICR is used by the Agency to ensure that facilities affected by the NESHAP continue to operate the control equipment and achieve compliance with the regulation. Adequate monitoring, recordkeeping, and reporting is necessary to ensure compliance with these standards, as required by the Clean Air Act. The information collected from recordkeeping and reporting requirements is also used for targeting inspections, and is of sufficient quality to be used as evidence in court. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 35 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Mills, Manufacturers, Fabricators, Landfills, Renovation/ Demolition Owners and/ or Operators. Estimated Number of Respondents: 9,848. Frequency of Response: On occasion, weekly, quarterly and semi­ annual. Estimated Total Annual Hour Burden: 342,249 hours. Estimated Total Annual Cost: $ 16,613,609. Changes in the Estimates: There is a decrease of 19,910 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This decrease is due to the reduction in the number of asbestos waste disposal sites subject to the asbestos NESHAP. Dated: December 10, 2002. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 02 32391 Filed 12 23 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OECA 2002 0019; FRL 7426 5] Agency Information Collection Activities; Submission of EPA ICR Number 1055.07 ( OMB No. 2060 0021) to OMB for Review and Approval; Comment Request AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: Title: NSPS for Kraft Pulp Mills subpart BB, OMB Control Number 2060 0021 and EPA ICR Number 1055.07, expiration date February 28, 2003. The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost. DATES: Additional comments may be submitted on or before January 23, 2003. ADDRESSES: Follow the detailed instructions in the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Maria ´ Malave ´ , Compliance Assessment and Media Program Division ( Mail Code 2223A), Office of Compliance, United States Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC. 20460; telephone number: ( 202) 564 7027; fax number: ( 202) 564 0050; e­ mail address: malave. maria@ epa. gov. Refer to EPA ICR Number 1055.07. SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On June 20, 2002 ( 67 FR 41981), EPA sought comments on this ICR pursuant to 5 CFR 1320.8( d). EPA received no comments. EPA has established a public docket for this ICR under Docket ID No. OECA 2002 0019, which is available for public viewing at the Enforcement and Compliance Docket and Information Center ( ECDIC) in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Avenue, NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the ECDIC is VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1

epa

2024-06-07T20:31:41.090376

regulations

EPA-HQ-OECA-2002-0019-0003

Notice

Agency Information Collection Activities; Submission of EPA ICR Number 1055.07 (OMB No. 2060-0021) to OMB for Review and Approval; Comment Request

78451 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices of asbestos insulation and spray materials; cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, NESHAP was promulgated for this source category at 40 CFR part 61, subpart M. The control of emissions of asbestos from the regulated sources requires not only the installation of properly designed equipment, but also the operation and maintenance of that equipment. Emissions of asbestos from the regulated sources are the result of operation of those sources ( milling, manufacturing, fabricating, waste disposal, and demolition and renovation). These standards rely on the capture and reduction of asbestos emissions by air cleaning equipment and specified work practices. The required notifications are used to inform the Agency or delegated authority when a source becomes subject to the standard. The reviewing authority may then inspect the source to check if the pollution control devices are properly installed and operated, the work practices are being followed and the standard is being met. Performance test reports are needed as these are the Agency's record of a source's initial capability to comply with the emission standard, and serve as a record of the operating conditions under which compliance was achieved. Thereafter, submission of semi­ annual reports of any visible emissions serves as the record of compliance. Waste conversion facilities must report initial testing conditions that become normal operating conditions for the plant. The quarterly reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations. Notification for each demolition or renovation activity allows the Agency or delegated authority to plan for inspections of the source in order to determine compliance with the work practices. Since each demolition or renovation is transitory in nature, notification must be made for each activity above the threshold limits specified in the regulation. The information generated by the monitoring, recordkeeping and reporting requirements described in this ICR is used by the Agency to ensure that facilities affected by the NESHAP continue to operate the control equipment and achieve compliance with the regulation. Adequate monitoring, recordkeeping, and reporting is necessary to ensure compliance with these standards, as required by the Clean Air Act. The information collected from recordkeeping and reporting requirements is also used for targeting inspections, and is of sufficient quality to be used as evidence in court. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 35 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Mills, Manufacturers, Fabricators, Landfills, Renovation/ Demolition Owners and/ or Operators. Estimated Number of Respondents: 9,848. Frequency of Response: On occasion, weekly, quarterly and semi­ annual. Estimated Total Annual Hour Burden: 342,249 hours. Estimated Total Annual Cost: $ 16,613,609. Changes in the Estimates: There is a decrease of 19,910 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This decrease is due to the reduction in the number of asbestos waste disposal sites subject to the asbestos NESHAP. Dated: December 10, 2002. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 02 32391 Filed 12 23 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OECA 2002 0019; FRL 7426 5] Agency Information Collection Activities; Submission of EPA ICR Number 1055.07 ( OMB No. 2060 0021) to OMB for Review and Approval; Comment Request AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: Title: NSPS for Kraft Pulp Mills subpart BB, OMB Control Number 2060 0021 and EPA ICR Number 1055.07, expiration date February 28, 2003. The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost. DATES: Additional comments may be submitted on or before January 23, 2003. ADDRESSES: Follow the detailed instructions in the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Maria ´ Malave ´ , Compliance Assessment and Media Program Division ( Mail Code 2223A), Office of Compliance, United States Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC. 20460; telephone number: ( 202) 564 7027; fax number: ( 202) 564 0050; e­ mail address: malave. maria@ epa. gov. Refer to EPA ICR Number 1055.07. SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On June 20, 2002 ( 67 FR 41981), EPA sought comments on this ICR pursuant to 5 CFR 1320.8( d). EPA received no comments. EPA has established a public docket for this ICR under Docket ID No. OECA 2002 0019, which is available for public viewing at the Enforcement and Compliance Docket and Information Center ( ECDIC) in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Avenue, NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the ECDIC is VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78452 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices ( 202) 566 1514. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: ( 1) Submit your comments to EPA online using EDOCKET ( our preferred method), by e­ mail to docket. oeca@ epa. gov, or by mail to: EPA Docket Center, Environmental Protection Agency, Mailcode: 2201T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, and ( 2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to www. epa. gov/ edocket. Title: NSPS for Kraft Pulp Mills subpart BB ( OMB Control Number 2060 0021 and EPA ICR Number 1055.07). This is a request to renew an existing approved collection that is scheduled to expire on February 28, 2003. Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. Abstract: The NSPS for Kraft Pulp Mills, published at 40 CFR part 60, subpart BB, was proposed on September 24, 1976, and promulgated on February 23, 1978. Revisions to the standards were promulgated on May 20, 1986. This rule addresses total reduced sulfur ( TRS) and particulate matter emissions from new, modified and reconstructed Kraft Pulp Mills. In addition to the monitoring, recordkeeping and reporting requirements listed in the General Provisions ( 40 CFR part 60, subpart A), Kraft Pulp Mills are required to continuously monitor and record at least once per shift specific parameters at the applicable affected facilities: The opacity of the gases discharged into the atmosphere from any recovery furnace; the concentration of TRS emissions on a dry basis and the percent of oxygen by volume on a dry basis in the gases discharged to the atmosphere; for an incinerator, the combustion temperature at the point of incineration of effluent gases being emitted by the affected facilities; and for any lime kiln or smelt discharge tank using a scrubber emission control device, the pressure loss of the gas stream through the control equipment and the scrubbing liquid pressure to the control equipment. Sources are also required to record on a daily basis 12­ hour average TRS concentrations and oxygen concentrations ( for the recovery furnace and lime kiln) for two consecutive periods of each operation. Sources must report semiannually measurements of excess emissions as defined by the standard for the applicable affected facility. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 62.4 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Kraft Pulp Mills/ brown stock washer systems, recovery furnaces, smelt dissolving tanks, lime kilns, black liquor oxidation systems and condensate stripper systems. Estimated Number of Respondents: 92. Frequency of Response: Initial, semiannual and on occasion. Estimated Total Annual Hour Burden: 12,107. Estimated Total Annual Non­ labor Cost: $ 3,143,600, includes $ 300,000 annualized capital costs and $ 2,844,000 annualized O& M costs. There is an increase of 2,148 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This increase is due to an increase and a more accurate estimate of the number of kraft pulp mills in the United States. The estimates on the number of existing and new sources were based on the active ICR, Federal Register publications on other sector­ related rules, consultation with OAQPS and industry, and queries conducted on two EPA databases including the Sector Facility Index Project and the Aerometric Information Retrieval System Facility Subsystem. Dated: December 10, 2002. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 02 32392 Filed 12 23 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OECA 2002 0005; FRL 7426 6] Agency Information Collection Activities; Submission for OMB for Review and Approval; Comment Request; NSPS for Hot Mix Asphalt Facilities, ICR Number 1127.07, OMB Number 2060 0083 AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: NSPS for Hot Mix Asphalt Facilities ( 40 CFR part 60, subpart I), VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1

epa

2024-06-07T20:31:41.093804

regulations

EPA-HQ-OECA-2002-0021-0005

Notice

Agency Information Collection Activities; Submission of EPA ICR No. 0152.07 (OMB No. 2070-0020) to OMB for Review and Approval; Comment Request

77979 Federal Register / Vol. 67, No. 245 / Friday, December 20, 2002 / Notices disposal facilities ( TSDFs) as may be necessary to protect human health and the environment. Subsections 3004( a)( 1), ( 3), ( 4), ( 5), and ( 6) specify that these standards include, but not be limited to, the following requirements: Maintaining records of all hazardous wastes identified or listed under subtitle C that are treated, stored, or disposed of, and the manner in which such wastes were treated, stored, or disposed of; Operating methods, techniques, and practices for treatment, storage, or disposal of hazardous waste; Location, design, and construction of such hazardous waste treatment, disposal, or storage facilities; Contingency plans for effective action to minimize unanticipated damage from any treatment, storage, or disposal of any such hazardous waste; and Maintaining or operating such facilities and requiring such additional qualifications as to ownership, continuity of operation, training for personnel, and financial responsibility as may be necessary or desirable. The regulations implementing these requirements are codified in the Code of Federal Regulations ( CFR) Title 40, parts 264 and 265. The collection of this information enables EPA to properly determine whether owners/ operators or hazardous waste treatment, storage, and disposal facilities meet the requirements of section 3004( a) of RCRA. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. The Federal Register document required under 5 CFR 1320.8( d), soliciting comments on this collection of information was published on August 13, 2002 ( 67 FR 52718); no comments were received. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 319 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Business or other for profit. Estimated Number of Respondents: 1,675. Frequency of Response: On occasion. Estimated Total Annual Hour Burden: 719,059. Estimated Total Annualized Capital, Operating/ Maintenance Cost Burden: $ 760,000. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the addresses above. Please refer to EPA ICR No. 1571.07 and OMB Control No. 2050 0120 in any correspondence. Dated: December 4, 2002. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 02 32132 Filed 12 19 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OECA 2002 0021; FRL 7425 5] Agency Information Collection Activities; Submission of EPA ICR No. 0152.07 ( OMB No. 2070 0020) to OMB for Review and Approval; Comment Request AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: Notices of Arrival of Pesticides and Devices ( OMB Control No. 2070 0020, EPA ICR No. 0152.07). The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost. DATES: Additional comments may be submitted on or before January 21, 2003. ADDRESSES: Follow the detailed instructions in the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Stephen Howie, Office of Compliance, 2225A, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 202) 564 4146; fax number: ( 202) 564 0085; e­ mail address: howie. stephen@ epa. gov. SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. The Federal Register Notice required under 5 CFR 1320.8( d), soliciting comments on this collection of information was published on July 16, 2002 ( 67 FR 46663 4), and no comments were received. EPA has established a public docket for this ICR under Docket ID No. OECA 2002 0021, which is available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the Enforcement and Compliance Docket and Information Center is ( 202) 566 1514. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: ( 1) Submit your comments to EPA online using EDOCKET ( our preferred method), by e­ mail to docket. oeca@ epa. gov, or by mail to: EPA Docket Center, Environmental Protection Agency, Mailcode: 2201T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and ( 2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public VerDate 0ct< 31> 2002 18: 25 Dec 19, 2002 Jkt 200001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 20DEN1. SGM 20DEN1 77980 Federal Register / Vol. 67, No. 245 / Friday, December 20, 2002 / Notices disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to www. epa. gov./ edocket. Title: Notices of Arrival of Pesticides and Devices ( OMB Control No. 2070 0020, EPA ICR No. 0152.07). This is a request to renew an existing approved collection scheduled to expire on December 31, 2002. Under the OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. Abstract: The U. S. Customs regulations at 19 CFR 12.112 require that an importer desiring to import pesticides into the United States shall, prior to the shipment's arrival, submit a Notice of Arrival of Pesticides and Devices ( EPA Form 3540 1) to EPA who will determine the disposition of the shipment. After completing the form, EPA returns the form to the importer, or his agent, who must present the form to Customs upon arrival of the shipment at the port of entry. This is necessary to insure that EPA is notified of the arrival of pesticides and devices as required by the Federal Insecticide Fungicide and Rodenticide Act ( FIFRA) section 17( c) and has the ability to examine such shipments to determine that they are in compliance with FIFRA. The information is used by EPA Regional pesticide enforcement and compliance staffs, OECA, and the Department of Treasury. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 0.3 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Importers of Pesticide and Devices. Estimated Number of Respondents: 18,500. Frequency of Response: 1. Estimated Total Annual Hour Burden: 5,550 hours. Estimated Total Annual Cost: $ 396,085. Changes in the Estimates: There is an increase of 3,450 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This increase is due to an adjustment in the number of respondents, based on a survey of responses reported to the EPA Regions in calendar year 2002. Dated: December 2, 2002. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 02 32133 Filed 12 19 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ ER FRL 6635 9] Environmental Impact Statements; Notice of Availability Responsible Agency: Office of Federal Activities, General Information ( 202) 564 7167 or http:// www. epa. gov/ compliance/ nepa/. Weekly receipt of Environmental Impact Statements. Filed December 9, 2002 through December 13, 2002. Pursuant to 40 CFR 1506.9. EIS No. 020509, Draft EIS, AFS, MO, Pineknot. Woodland Restoration Project, Restoring Open Shortleaf Pine Woodland on the 10,831 Acre, Implementation, Doniphan/ Eleven Point Ranger District, Mark Twain National Forest, Carter County, MO, Comment Period Ends: February 3, 2003, Contact: Jerry Bird ( 573) 996 2153. EIS No. 020510, Draft Supplement, FHW, WV, VA, Appalachian Corridor H Project, Construction of a 10­ mile Highway between the Termini of Parsons and Davis, In Pursuant to the February 2000 Settlement Agreement, Tucker County, WV and VA, Comment Period Ends: February 21, 2003, Contact: Thomas J. Smith ( 304) 347 5928. EIS No. 020511, Draft EIS, COE, MD, Aberdeen Proving Ground ( APG) Project, To Conduct Research and Development, Test and Evaluate Ordnance, Military Equipment and to Train Personnel, Chesapeake Bay, Harford, Baltimore, Kent and Cecil Counties, MD, Comment Period Ends: February 3, 2003, Contact: Tracy Dunne ( 410) 278 2479. EIS No. 020512, Final Supplement, NRC, Generic EIS Decommissioning of Nuclear Facilities, Updated Information on Dealing With Decommissioning of Nuclear Power Reactors ( NUREG 0586), Wait Period Ends: January 21, 2003, Contact: Michael T. Masnik ( 301) 415 1191. EIS No. 020513, Draft EIS, SFW, WA, Nisqually National Wildlife Refuge ( NWR), To Adopt and Implement a Comprehensive Conservation Plan, Puget Sound, Nisqually River Delta, Thurston and Pierce Counties, WA, Comment Period Ends: February 21, 2003, Contact: Michael Marxen ( 503) 590 6596. This document is available on the Internet at: http:// www. pacific. fws. gov/ planning. EIS No. 020514, Legislative Draft, AFS, WA, I 90 Wilderness Study, To Review Land Comprising of 15,000 Acres for Suitability for Preservation as Wilderness, Omnibus Consolidated and Emergency Supplemental Appropriations Act, Okanogan and Wenatchee National Forests, Kittitas and Chelan Counties, WA, Comment Period Ends: February 18, 2003, Contact: Floyd Rogalski ( 509) 674 4411. This document is available on the Internet at: http:// www. fs. fed. us/ r6/ wenatchee/ planning/ i­ 90­ wilderness­ study. pdf. EIS No. 020515, Draft EIS, AFS, OR, Metolius Basin Forest Management Project, To Implement Fuel Reduction and Forest Health Management Activities, Deschutes National Forest, Sisters Ranger District, Jefferson County, OR, Comment Period Ends: February 15, 2003, Contact: Kris Martinson ( 541) 549 7730. This document is available on the Internet at: http:// www. fs. fed. us/ r6/ centraloregon/ index­ metolius. htm. EIS No. 020516, Draft Supplement, FTA, OR, WA, OR, South Corridor Project a Portion of the South/ North Corridor VerDate 0ct< 31> 2002 18: 25 Dec 19, 2002 Jkt 200001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 20DEN1. SGM 20DEN1

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EPA-HQ-OECA-2004-0048-0002

Supporting & Related Material

STANDARD FORM 83­ I SUPPORTING STATEMENT FOR OMB REVIEW OF ICR NO. 1983.02 INFORMATION COLLECTION REQUEST FOR THE CHANGES TO GENERIC MACT TO INCORPORATE THE CARBON BLACK PRODUCTION SOURCE CATEGORY CYANIDE CHEMICALS MANUFACTURING SOURCE CATEGORY ETHYLENE PRODUCTION SOURCE CATEGORY AND SPANDEX PRODUCTION SOURCE CATEGORY U. S. ENVIRONMENTAL PROTECTION AGENCY EMISSION STANDARDS DIVISION RESEARCH TRIANGLE PARK, NORTH CAROLINA 27711 December 8, 2004 1 PART A OF THE SUPPORTING STATEMENT 1. Identification of the Information Collection ( a) Title and Number of the Information Collection. " Recordkeeping and Reporting Requirements for Source Categories: Generic Maximum Achievable Control Technology Standards." This is a new information collection request ( ICR). This is a new information collection request ( ICR) and the tracking number is EPA ICR No. 1983.02. ( b) Short Characterization. This ICR is prepared for a U. S. Environmental Protection Agency ( EPA) proposed rulemaking being developed under authority of Section 112 of the Clean Air Act ( Act). The proposed rulemaking would amend title 40, chapter I, part 63 of the Code of Federal Regulations ( CFR) by adding additional standards to the existing subpart YY ­­ National Emission Standards for Hazardous Air Pollutants for Source Categories: Generic Maximum Achievable Control Technology Standards ( this subpart is referred to as the " generic MACT NESHAP"). The generic MACT NESHAP includes standards for major sources of hazardous air pollutants ( HAP). Respondents are owners or operators of source category affected sources regulated under the generic MACT NESHAP. This ICR is for HAP emission sources in the carbon black ( CB) production, cyanide ( CY) chemicals manufacturing, ethylene ( ET) production, and spandex ( SP) production source categories. For the purposes of this ICR the phrases " cyanide chemicals manufacturing," " cyanide production," and " CY production" have the same meaning. The CB production source category consists of 20 facilities that would ( and 2 facilities that would not) be subject to the major source provisions specified under the generic MACT NESHAP. We anticipate that 5 of these facilities will conduct all 2 monitoring, inspection, recordkeeping, and reporting ( MIRR) requirements, including testing activities. The estimated MIRR costs per facility to conduct all MIRR activities is $ 47,790. Fifteen facilities will conduct all MIRR requirements, except testing activities. The estimated MIRR costs per facility to conduct all MIRR activities, except testing and related tasks, is $ 45,740. The two facilities that are not major sources will read the rule. The estimated costs for this one activity is $ 410 per facility. Based on these estimates, the total MIRR cost of the proposed rulemaking for the carbon black production source category is estimated to be $ 925,830 for the first three years after promulgation of the proposed standards. See Section 6 for more details. The CY production source category consists of 14 facilities that would ( and 2 facilities that would not) be subject to the major source provisions specified under the generic MACT NESHAP. We anticipate that only 1 of these facilities will be subject to all monitoring, inspection, recordkeeping, reporting ( MIRR) requirements, including testing and control device design analysis activities, excluding those associated with the development of a new leak detection program. The estimated MIRR costs per facility to conduct these activities is $ 58,460. Eight facilities will be subject to all monitoring, inspection, recordkeeping, reporting, and leak detection system requirements, excluding those associated with control equipment design analysis. The estimated MIRR costs to conduct these activities is $ 59,076 per facility. Five facilities will be subject to general reporting and recordkeeping requirements, excluding those associated with control device design analysis and implementation of a new leak detection system. The estimated MIRR costs to conduct these activities is $ 56,414 per facility. The two facilities that are not major sources will read the rule and 3 review rule information. The estimated costs for these two activities is $ 614 per facility. Based on these estimates, the total MIRR cost of the proposed rulemaking for the cyanide chemicals manufacturing source category is estimated to be $ 814,366 for the first three years after promulgation of the proposed standards. See section 6 for more details. The ET production source category consists of 37 facilities that would be subject to the major source provisions specified under the generic MACT NESHAP. We anticipate that all 37 of these facilities are major sources and will conduct all monitoring, inspection, recordkeeping, and reporting ( MIRR) requirements, including testing activities. The estimated MIRR costs per facility to conduct all MIRR activities is $ 72,383. Based on these estimates, the total MIRR cost of the proposed rulemaking for this source category is estimated to be $ 2,678,184 for the first three years after promulgation of the proposed standards. See section 6 for more details. The SP production source category consists of 2 facilities that would be subject to the major source provisions specified under the generic MACT NESHAP. We anticipate that these 2 facilities will conduct all monitoring, inspection, recordkeeping, and reporting ( MIRR) requirements, including testing activities. The estimated MIRR costs per facility to conduct all MIRR activities is $ 56,050. This gives total MIRR costs of $ 112,110 for the spandex production source category during the first three years after promulgation of a NESHAP for this source category. See section 6 for more details. All existing sources must be in compliance with the requirements of the generic MACT NESHAP within 3 years of the effective date ( promulgation date) of standards for an affected source. All new sources must be in compliance with the requirements of the generic MACT NESHAP upon startup or the 4 promulgation date of standards for an affected source, whichever is later. 2. Need For and Use of the Collection ( a) Need/ Authority for the Collection. The EPA has been directed by section 112 of the Act to regulate the emission of HAP from stationary sources. Carbon black, cyanide, ethylene and spandex production source categories; and any source categories that may be regulated under the generic MACT NESHAP in the future are major sources of HAP emissions included on the EPA's list of categories scheduled for regulation. Section 114 of the Act gives the EPA authority to collect data and information necessary to enforce standards established under section 112 of the Act. Certain records and reports are necessary to enable the Administrator to ( 1) identify existing and new sources subject to the generic MACT NESHAP and ( 2) ensure that the requirements specified for an affected source subject to the generic MACT NESHAP, which are based on MACT, are being achieved. ( b) Use/ Users of the Data. The information will be used by the EPA's enforcement personnel to ( 1) identify existing and new HAP emission points subject to the generic MACT NESHAP, ( 2) identify the emission control devices and methodologies being applied, and ( 3) ensure that the emission control devices and methodologies are being properly operated and maintained on a continuous basis. Records and reports are necessary to enable the EPA to identify facilities subject to the generic MACT NESHAP that may not be in compliance. Based on reported information, the EPA can decide whether to inspect a facility and which records or processes to inspect. The records that facilities maintain would 5 indicate to the EPA whether facility personnel are operating and maintaining emission control devices and methodologies properly. 3. The Respondents and the Information Requested ( a) Respondents/ SIC and NAICS Codes. Respondents are owners or operators of HAP­ emitting affected sources in the CB production, CY production, ET production, and SP production source categories; and HAP­ emitting affected sources in source categories with a limited population of major sources that may be regulated under the generic MACT standards in the future. The source categories and affected sources regulated with the initial proposal of the generic MACT NESHAP are classified in the four­ digit Standard Industrial Classification ( SIC) Codes: 2895 for CB productiuon; 2819 and 2869 for CY production; 2869 for ET production; and, 2824 for SP production. The source category and affected sources regulated with this proposal are also classified in the six­ digit North American Industrial Classification System ( NAICS) codes: 325182 for CB productiuon; 325188 and 325199 for CY production; 325110 for ET production; and, 325222 for SP production. Not all processes and facilities classified under these SIC and NAICS codes would be regulated under the generic MACT NESHAP. ( b) Information Requested. ( i) Data items, including recordkeeping requirements. The generic MACT NESHAP would require that an owner or operator of a major source reduce specified affected source HAP emissions. The affected source and emissions control requirements are determined on a source category­ specific basis. Attachment 1, Source Data and Information Requirement, summarizes the recordkeeping and reporting requirements, and specific rule provisions that require them, for the CB production, CY production, ET production, and SP production source categories. Information requirements being proposed under the generic MACT NESHAP that would apply to all 6 source categories that would be regulated with this proposal are discussed in the following paragraphs. Respondents are required to submit one­ time reports of the ( 1) start of construction for new facilities, ( 2) anticipated and actual start­ up dates for new facilities, and ( 3) physical or operational changes to existing facilities. Owners and operators must also submit semi­ annual reports of the monitoring results under the leak detection and repair program ( if applicable for a subject source category). All records are to be maintained by the facility for a period of at least 5 years. An affected source with an initial startup date before the promulgation date of standards for an affected source under the generic MACT NESHAP must submit a one­ time initial notification. This initial notification must be submitted within one year after the promulgation date of standards for an affected source under the generic MACT NESHAP ( or within 1 year after the affected source becomes subject to the generic MACT NESHAP). For sources constructed or reconstructed after the promulgation date of standards for an affected source under the generic MACT NESHAP, the source must submit an application for approval of construction or reconstruction. The application is required to contain information on the air pollution control that will be used for each potential HAP emission point. The information in the initial notification and the application for construction or reconstruction will enable enforcement personnel to identify the number of sources subject to, or are already in compliance with, the standards. Affected sources subject to standards under the generic MACT NESHAP must submit a notification of compliance status. This notification must be signed by a responsible company official who certifies its accuracy and that the affected source has complied with the relevant standards. Performance test results ( as 7 applicable) are included as part of the compliance status report. The notification of compliance status must be submitted within 60 days after the compliance date specified for an affected source subject to the generic MACT NESHAP. In addition, affected sources subject to the proposed generic MACT NESHAP that would be required to install continuous parameter monitoring systems ( CPMS) are required to conduct a performance evaluation of the CPMS. A report of the performance evaluation results is required to be submitted to the delegated authority. Excess emissions and CPMS performance reports documenting excess emissions and parameter monitoring exceedances are required to be submitted to the delegated authority semiannually Submittal of these reports is required quarterly when the CPMS data are used to demonstrate compliance and the facility experiences excess emissions. The generic MACT NESHAP requires owners or operators of affected sources to develop startup, shutdown, and malfunction plans, documenting procedures that will be taken in the case of any of these events. Startup, shutdown, and malfunction reports demonstrating the actions taken by an owner or operator in the event of a startup, shutdown, or malfunction are required to be submitted. Reports are required semi­ annually when actions taken are consistent with the plan. Immediate reports are required when actions taken are inconsistent with the plan. The generic MACT NESHAP would require owners or operators of an affected source to retain records for 5 years, which exceeds the three year retention period contained in the guidelines in 5 CFR 1320.6. The 5 year retention period is consistent with the provisions of the General Provisions of 40 CFR Part 63 and the retention requirement in the operating permit program under Title V of the Act. ( ii) Respondent Activities. 8 Respondent activities for major sources are shown for each of the first 3 years following promulgation of the rule. The respondent activities required by the generic MACT NESHAP for the CB production, CY production, ET production, and SP production source categories for existing sources are presented in the first column of Tables 1a, 1b, and 1c for CB production; Tables 2a, 2b, and 2c for CY production; Tables 3a, 3b, and 3c for ET production; and Tables 4a, 4b, and 4c for SP production. There are no new sources anticipated for any of these source categories within the first 3 years after promulgation of standards for subject affected sources. These tables are introduced in Section 6( a) of this ICR. 4. The Information Collected­­ Agency Activities, Collection Methodology, and Information Management ( a) Agency Activities. A list of the EPA's activities is provided in Tables 5a through 5d. These tables are introduced in Section 6( c) of this ICR. ( b) Collection Methodology and Management. Information contained in the one­ time only reports will be entered into the Aerometric Information Retrieval System ( AIRS) Facility Subsystem ( AFS) that is maintained and operated by the EPA's Office of Air Quality Planning and Standards ( OAQPS). Data obtained during periodic visits by EPA personnel from records maintained by the respondents will be tabulated and published for internal EPA use in compliance and enforcement programs. ( c) Small Entity Flexibility. Minimizing the information collection burden for all sizes of organizations is a continuing effort on the EPA's part. The EPA has reduced the recordkeeping and reporting requirement respondent burden to include only the information needed by the EPA to determine compliance with the generic MACT NESHAP. 9 ( d) Collection Schedule. Collection of data will begin after promulgation of standards under the generic MACT NESHAP. The schedule for reports required by the generic MACT NESHAP for the CB production, CY production, ET production, and SP production source categories; and source categories that may be regulated under the generic MACT NESHAP in the future are summarized below. The initial notification is due one year after the date of promulgation for existing sources. The notification of compliance status would be submitted 60 days following completion by the source of the compliance demonstration specified in the regulation. Major sources would be required to submit periodic excess emissions and CPMS performance summary reports on a semi­ annual basis. Major sources must submit startup, shutdown, malfunction reports semi­ annually when actions taken in the event of a startup, shutdown, or malfunction are consistent with the source's startup, shutdown, malfunction plan. If actions taken are not consistent with the source's plan, an immediate report must be submitted. The equipment leak standards would require the submittal of an initial report and semi­ annual reports of LDAR experiences and any changes to the processes, monitoring frequency and initiation of a quality improvement program. The schedule for submission of these reports is detailed below. For existing sources, the owner or operator would be required to submit the initial report within 90 days after the applicability date of standards for an affected source under the generic MACT NESHAP. For new sources, the initial report would be submitted with the application for construction. Every 6 months after the initial report, a report would be submitted that summarizes the monitoring results from the LDAR 10 program and provides a notification of initiation of monthly monitoring, if applicable. 5. Nonduplication, Consultations, and Other Collection Criteria ( a) Nonduplication. A search of the EPA's existing standards and ongoing ICRs revealed no duplication of information gathering efforts. However, certain reports required by State or local agencies may duplicate information required under the generic MACT NESHAP. In such cases, a copy of the report submitted to the State or local agency can be provided to the Administrator in lieu of the report required by the generic MACT NESHAP. ( b) Consultations. Consultations with numerous representatives of companies involved in CB production, CY production, ET production, and SP production source categories were conducted in the presumptive MACT development process and the generic MACT NESHAP development process which establishes MACT for each of these source categories. Tables 9, 10, 11, and 12 present the names, affiliation, and telephone numbers of persons that provided input during the development of the proposed generic MACT NESHAP for the CB production, CY production, ET production, and SP production source categories. For future source categories that would be regulated under the generic MACT NESHAP the EPA would consult with industry representatives and State agencies when developing the presumptive MACT and MACT for an applicable source category. A 90­ day public comment period will be provided after proposal, during which all affected parties will be given the opportunity to comment on the generic MACT NESHAP. All received comments will be considered and some may be reflected in the development of the promulgated generic MACT NESHAP. 11 TABLE 9. CARBON BLACK PRODUCTION CONSULTATIONS Name Affiliation Telephone number Penny Lassiter U. S. Environmental Protection Agency ( 919) 541­ 5396 John Schaefer U. S. Environmental Protection Agency ( 919) 541­ 0296 Bill Fleming Cabot Corporation ( 678) 297­ 1534 Todd Williams Chevron Chemical Company ( 281) 421­ 6386 Roy Holder Columbian Chemicals Company ( 770) 792­ 9432 Todd N. Miller Continental Carbon Company ( 281) 647­ 3858 John Tarabocchia Degussa­ Hüls Corporation ( 334) 443­ 3537 Jimmy Boyd Engineered Carbons, Incorporated ( 806) 273­ 1454 Herb Harless Sid Richardson Carbon Company ( 817) 338­ 8386 James Orgeron Louisiana DEQ ( 225) 765­ 0131 Evelina Morales Oklahoma DEQ ( 405) 702­ 4194 Fred Wilson Texas NRCC ( 512) 239­ 1285 James Randall Texas NRCC ( 512) 239­ 1078 Renu Chakrabarty West Virginia DEP ( 304) 558­ 0885 TABLE 10. CYANIDE CHEMICALS MANUFACTURING CONSULTATIONS Name Affiliation Telephone number Penny Lassiter U. S. Environmental Protection Agency ( 919) 541­ 5396 Keith Barnett U. S. Environmental Protection Agency ( 919) 541­ 5605 Martin Brittain U. S. Environmental Protection Agency ( 214) 665­ 7296 Diane McConkey U. S. Environmental Protection Agency ( 202) 564­ 5588 Jeff Gilman BP Amaco ( 630) 420­ 5205 Name Affiliation Telephone number 12 Ann Goulet BP Amaco ( 419) 226­ 1239 Van A. Boone BP Chemicals ( 361) 552­ 8642 Erica Dromgolle BP Chemicals ( 361) 552­ 8642 Rasma Zvaners Chemical Manufacturers Association ( 703) 741­ 5249 Anita Junker Cytec ( 504) 431­ 6556 Orey Tanner Cytec ( 504) 431­ 6556 Mark Armentrout Degussa Corporation ( 334) 443­ 4250 David Jelly The Dow Chemical Company ( 713) 246­ 0133 Debbie Mulrooney Du Pont Chemicals ( 302) 774­ 8083 Scott Collins Du Pont Chemicals ( 361) 572­ 1538 Ellen Lane Du Pont Chemicals ( 409) 882­ 3290 Walter Schrimper Du Pont Chemicals ( 901) 353­ 7595 Dale Clark FMC ( 307) 872­ 2195 Richard Ober Louisiana Department of Environmental Quality ( 225) 765­ 0113 Bill Sprott Memphis and Shelby County Health Department ( 901) 544­ 7725 Bruce Raff Novartis ( 225) 642­ 1686 Dave Fewell Rhone­ Poulenc ( 304) 767­ 6771 Richard DiMenna Rohm & Haas Incorporated ( 281) 592­ 2339 Edward G. Fiesinger Solutia Incorporated ( 281) 228­ 4486 Jeffery S. Gilbert Sterling Chemicals ( 409) 945­ 4431 Ruben Herrera Texas Natural Resource Conservation Commission ( 512) 239­ 5866 TABLE 11. ETHYLENE PRODUCTION CONSULTATIONS Name Affiliation Telephone number Penny Lassiter U. S. Environmental Protection Agency ( 919) 541­ 5396 Warren Johnson U. S. Environmental Protection Agency ( 919) 541­ 5124 Name Affiliation Telephone number 13 Robert Todd U. S. Environmental Protection Agency ( 214) 665­ 2156 Martin Brittain U. S. Environmental Protection Agency ( 214) 665­ 7296 Diane McConkey U. S. Environmental Protection Agency ( 202) 564­ 5588 Trish Messenger Chemical Manufacturers Association ( 703) 534­ 3582 John Ogle Dow ( 409) 238­ 2819 Stan Labat Exxon ( 225) 359­ 7226 James Orgeron Louisiana DEQ ( 225) 765­ 3595 Donna Hathaway Louisiana DEQ ( 225) 765­ 0182 Dana Poppa­ Vermillion Texas NRCC ( 512) 239­ 1280 TABLE 12. SPANDEX PRODUCTION CONSULTATIONS Name Affiliation Telephone Number 14 Lance Granger Bayer Corporation ( 803) 820­ 6201 Ron Shifflett DuPont ( 540) 949­ 2844 Rodney Gearhart Globe Manufacturing ( 508) 674­ 3585 Larry Brown Alabama DEM ( 334) 271­ 7861 Tom Garrett Alabama DEM ( 334) 271­ 7861 Don Squires Massachusetts DEP ( 617) 292­ 5618 Mike Landis North Carolina DEM ( 704) 663­ 1699 Kisha Thompson South Carolina BAQ ( 803) 734­ 5117 Michael Kiss Virginia APC ( 540) 574­ 7822 Gordon Kerby Virginia APC ( 540) 574­ 7822 Gerald Potamis US EPA Region 1 ( 617) 918­ 1651 Dianne Walker US EPA Region 3 ( 215) 566­ 3297 Lee Page US EPA Region 4 ( 404) 562­ 9131 Kathleen Reeves Fornay US EPA Region 4 ( 404) 562­ 9130 Angela Catalano US EPA Region 7 ( 913) 551­ 7411 K. C. Hustvedt US EPA ( 919) 541­ 5395 Elaine Manning US EPA ( 919) 541­ 5499 ( c) Effects of Less Frequent Collection. 15 If the relevant information were collected less frequently, the EPA would not be reasonably assured that an affected source is in compliance with the generic MACT NESHAP. In addition, the EPA's authority to take administrative action would be reduced significantly. Section 113( d) of the Act limits the assessment of administrative penalties to violations which occur no more than 12 months before initiation of the administrative proceeding. Since administrative proceedings are less costly and require use of fewer resources than judicial proceedings, both the EPA and the regulated community benefit from preservation of the EPA's administrative powers. ( d) General Guidelines. The generic MACT NESHAP would require owners or operators of an affected source to retain records for 5 years, which exceeds the 3 year retention period contained in the guidelines in 5 CFR 1320.6. The 5 year retention period is consistent with the provisions of the General Provisions of 40 CFR Part 63 and the retention requirement in the operating permit program under Title V of the Act. ( e) Confidentiality and Sensitive Questions. i. Confidentiality. All information submitted to the EPA for which a claim of confidentiality is made will be safeguarded according to the EPA policies set forth in Title 40, Chapter 1, Part 2, Subpart B, Confidentiality of Business Information. See 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 3999, September 8, 1978; 43 FR 42251, September 28, 1978; and 44 FR 17674, March 23, 1979. Even when the EPA has determined that data received in response to an ICR is eligible for confidential treatment under 40 CFR Part 2, Subpart B, the EPA may nonetheless disclose the information if it is " relevant in any proceeding" under the statute [ 42 U. S. C. § 7414 ( C); 40 CFR 2.301 ( g)]. This 16 information collection complies with the Privacy Act of 1974 and Office of Management and Budget ( OMB) Circular 108. ii. Sensitive Questions. Information to be reported consists of emissions data and other information that are not of a sensitive nature. No sensitive personal or proprietary data are being collected. 6. Estimating Burden and Cost of the Collection ( a) Estimating Respondent Burden. The existing major source annual burden estimates for recordkeeping and reporting are presented in Tables 1a through 1d for CB production; Tables 2a through 2d for CY production; Tables 3a through 3d for ET production; and Tables 4a through 4d for SP production. There is no annual burden estimate for new major sources based on the assumption that there will be very few new sources subject to the generic MACT NESHAP in the first 3 years after promulgation of standards for these source categories. The estimates of total technical labor hours per year per source and the number of activities per respondent per year listed in each table are based upon experience with similar information collection requirements in other standard development efforts and the number of emission points in each source. Activities that are one­ time only activities are noted in the tables. [ Table 1a] 17 [ End Table] [ Table 1b] 18 [ End Table] [ Table 1c] 19 [ End Table] [ Table 1d] 20 [ End Table] [ Table 2a] 21 [ End Table] [ Table 2b] 22 [ End Table] [ Table 2c] 23 [ End Table] [ Table 2d] 24 [ End Table] [ Table 3a] 25 [ End Table] [ Table 3b] 26 [ End Table] [ Table 3c] 27 [ End Table] [ Table 3d] 28 [ End Table] [ Table 4a] 29 [ End Table] [ Table 4b] 30 [ End Table] [ Table 4c] 31 [ End Table] [ Table 4d] 32 [ End Table] ( b) Estimating Respondent Costs. 33 The information collection activities for the first 3 years for affected sources subject to the generic MACT NESHAP with this proposal are presented in Tables 1a through 4d. The costs of these activities are based on the 1992 Comprehensive Assessment and Information Rule ( CAIR) economic analysis with estimated wage rates of $ 66.73 per hour ($ 66.73/ hr) for management labor, $ 45.04/ hr for technical labor, and $ 28.14/ hr for administrative labor. For the purposes of this analysis, it is assumed that each labor hour is composed of 5 percent management, 85 percent technical, and 10 percent administrative. The EPA believes that these estimates reflect the maximum ICR burden that would occur as a result of the generic MACT NESHAP, considering source categories that could be potentially regulated under the generic MACT NESHAP in the future. ( c) Estimating the EPA's Burden and Cost. Because the information collection requirements were developed as an incidental part of the generic MACT NESHAP, no costs can be attributed to the development of the information collection requirements. Because recordkeeping and reporting requirements on the part of the respondents are required under section 112 of the Act, no operational costs will be incurred by the Federal government. Publication and distribution of the information are part of the AFS operated and maintained by OAQPS, with the result that no Federal costs can be directly attributed to the ICR. Examination of records to be maintained by the respondents will occur incidentally as part of the periodic inspection of affected sources. Periodic inspections are part of the EPA's overall compliance and enforcement program. Therefore, these examinations are not attributable to the ICR. The only costs that the Federal government will incur are user costs associated with the analysis of the reported information, as presented in 34 Tables 5a through 5d for source categories regulated under the generic MACT NESHAP with this proposal. These burden estimates assume that there will be no new sources in the first 3 years following promulgation of standards for the subject source categories. Labor rates and associated costs are based on estimated wage rates $ 56/ hr ( GS­ 15/ 3 level) for management, $ 34/ hr ( GS­ 12/ 3 level) for technical, and $ 17/ hr ( GS­ 6/ 3 level) for administrative. Labor rates include 60 percent for overhead expenses. 35 [ Table 5a] [ End Table] 36 [ Table 5b] [ End Table] 37 [ Table 5c] [ End Table] 38 [ Table 5d] [ End Table] 39 [ Table 6a] [ End Table] 40 [ Table 6b] [ End Table] 41 [ Table 6c] [ End Table] 42 [ Table 6d] [ End Table] 43 [ Table 7a] [ End Table] 44 [ Table 7b] [ End Table] 45 [ Table 7c] [ End Table] 46 [ Table 7d] [ End Table] 47 [ Table 8a] [ End Table] 48 [ Table 8b] [ End Table] 49 [ Table 8c] [ End Table] 50 [ Table 8d] [ End Table] 51 ( d) Bottom Line Burden Hours and Costs/ Master Tables. i. The Simple Collection. The bottom line respondent burden hours and costs, presented in Tables 1a through 4d, are calculated by adding total person­ hours and costs from each of the tables. The estimated total nationwide burden for the first 3 years for regulated major sources being added to the generic MACT NESHAP would be an estimated 33,926 total labor hours per year at a cost of approximately $ 1,510,000 per year. The total estimated annual labor hour reporting and recordkeeping burden is 33,936. The total annualized capital and startup costreflects the estimated capital costs for equipment required for monitoring, inspection, recordkeeping, and reporting ( MIRR) activities associated with the major source provisions of the proposed standards. The total estimated installed capital costs of this equipment is $ 2,119,000 for the CB production source category, $ 53,000 for the CY production source category, $ 2,663,000 for the ET production source category, and $ 66,000 for the SP production source category, for an annual estimated total of $ 4,901,000. The total annual estimated operating and maintenance costs ( O& M) are calculated based on ( 1) the estimated storage, filing, photocopying, and postage costs for the estimated total number of annual responses associated with the proposed provisions for each of the source categories and ( 2) the O& M costs for the equipment required for CPMS. Storage, filing, and photocopying costs per response is estimated at 0.5 hour of administrative labor at a rate of $ 25/ hr or $ 12.50 per response for multiple copies. First class postage is estimated at $ 7.63 per response for mailing of an one pound package and two one half pound packages to regulatory agencies. The total storage, filing, photocopying, and postage cost per response is approximately $ 20.13. The total 52 annual estimated O& M cost is $ 1,900 for the CB production source category based on 93 responses, $ 1,300 for the CY production source category based on 65 annual responses, $ 3,000 for the ET production source category based on 150 responses, and $ 9,600 for the SP source category based upon 13 responses plus CPMS costs, for an annual estimated total of $ 15,800 for 312 responses. ii. The EPA Tally. The bottom line Federal government burden hours and costs that would result from this ICR are presented in Tables 5a through 8d for the source categories being proposed with this proposal. These estimates are calculated by adding total person­ hours and costs from each of the tables. Table 5d summarizes the Federal government burden hours and costs for existing CB production, CY production, ET production, and SP production source categories. The estimated total annual labor hours and costs of the generic MACT NESHAP for the CB production, CY production, ET production, and SP production source categories in the first 3 years after promulgation are approximately 3,465 total labor hours per year at a cost of approximately $ 116,527 per year. iii. The Complex Collection. This collection is a simple collection, therefore, this section does not apply. iv. Variations in the Annual Bottom Line. Variation in the annual bottom line for this regulation may occur ( 1) due to the fact that certain one­ time activities would typically occur in the first year following promulgation of the rule and ( 2) by the third year following promulgation of the rule, when all sources must be in compliance, and will therefore be subject to recurring recordkeeping and reporting requirements. ( e) Reasons for Change in Burden. This section does not apply because this is a new collection. 53 PART B OF THE SUPPORTING STATEMENT Not applicable. No sampling or other methods are used to select respondents because all owners and operators of facilities subject to the generic MACT NESHAP would be required to collect information. 54 ATTACHMENT 1 SOURCE DATA AND INFORMATION REQUIREMENTS REQUIREMENT REGULATION CITATION MONITORING & INSPECTION Install, maintain, adjust, and calibrate CPMS § 63.996( c) Inspect and monitor covers § 63.1063( c) Inspect and monitor closed­ vent or heat exchange system § 63.983( b) § 63.983( c) § 63.1084( a) Monitor control device § 63.984( b) § 63.986( c) § 63.987( c) § 63.988( c) § 63.989( c) § 63.990( c) § 63.991( c) § 63.992( c) § 63.993( c) § 63.994( c) § 63.995( c) § 63.996( c) Develop startup, shutdown, and malfunction plan § 63.1110( b) § 63.1111 REQUIREMENT REGULATION CITATION 55 RECORDKEEPING Records of maintenance § 63.1088( b) § 63.1090( c) § 63.1089 § 63.1109( a) Records of startup, shudown and malfunction and actions taken § 63.998( d) Records of malfunctioning or inoperative CPMS § 63.998( c) Records of CPMS operation, adjustments, calibration checks, and maintenance § 63.998( c) Records of performance test and performance evaluation results § 63.998( a) Records of initial and compliance status notifications § 63.998( a) REPORTS Initial Notification § 63.1110( a) § 63.1110( c) Initial Compliance Status Report § 63.1110( a) § 63.1110( d) Notification of performance evaluation and performance test dates § 63.1110( a) REQUIREMENT REGULATION CITATION 56 Performance test and performance evaluation results § 63.1090 § 63.1110( d) Startup, shutdown, and malfunction reports § 63.1110( a) § 63.1111 Excess emissions and CPMS performance report § 63.1110( a) Excess emissions and CPMS performance summary report § 63.1110( a) Operating parameter value and rationale selection § 63.1110( a) § 63.1111 Conduct control device performance test § 63.987( c) § 63.988( b) § 63.989( b) § 63.990( b) § 63.991( b) § 63.992( b) § 63.993( b) § 63.994( b) § 63.995( b) Conduct CPMS performance evaluation § 63.996( b)

epa

2024-06-07T20:31:41.103612

regulations

EPA-HQ-OECA-2005-0061-0002

Supporting & Related Material

­­ e UNITED STATES ENVIRONMENTAL PROTECTION AGENCY BEFORE THE ENVIRONMENTAL APPEALS BOARD IN THE MATTER OF: NEXTEL Communications, Inc., et. al. 200 1 Edmond Halley Dr. Reston, Virginia 20191 NII Holdings, Inc 10700 Parkridge Blvd. Suite 600 Reston, Virginia 20191 Respondents 1 1 1 ) ) ) 1 ) Docket No. EPCRA­ HQ­ 2002­ 6001 Docket No. CWA­ HQ­ 2002­ 6001 Docket No. CAA­ HQ­ 2002­ 600 1 Docket No. RCRA­ HQ­ 2002­ 600 1 CONSENT AGREEMENT I. Preliminary Statement A. Complainant, the United States Environmental Protection Agency ( EPA), and Nextel Communications, Inc., its subsidiaries listed in Attachment A, ( collectively Nextel) and NII Holdings, Inc., collectively referred to as Respondents , having consented to the terms of this Consent Agreement ( Agreement), and before the taking of any testimony and without the adjudicationof issues of law or fact herein, agree to comply with the terns of this Agreement and attached proposed Final Order hereby incorporatedby reference. B. On August 10,2001, pursuant to EPA s Policy on Incentives for Self­ Policing( Audit Policy), 65 Fed. Reg. 19,618 ( April 11,2000), Respondents submitted an initial voluntary disclosure to EPA regarding potential violations of: 1. Emergency Planning and Community Right­ to­ Know Act ( EPCRA) $$ 302­ 303, ­­> 42 U. S. C. $ 9 11002­ 11003; 2 EPCRA 0 311,42U. S. C. 6 11021; 3. EPCRA 0 312,42 U. S. C. $ 11022; 4. Clean Water Act ( CWA) $ 311( j)( l)( C); 33 U. S. C. 0 1321U)( l)( C); = AL.­.­­=­ A. v , uL­ s­ sT=­... . 5. Clean Air Act ( CAA), 0 110,42 U. S. C. 6 7410, and the requiremmts adptFjkasi, gyt ­ 7 .. %. aof State Implementation Plans ( SIPS); I i j DEc 13 2002 6. Resource Conservation and Recovery Act ( RCRA) $ 9 9002­ 900313 ! 1 42 U. S. C. § $ 6991a­ 6991b; and 4 7. RCRA 3002,42 U. S. C. 6922. C. Respondents continued to submit additional and periodic disclosures for the above statutes. Such disclosures have resulted in a final list of disclosed violations found in Attachment B, hereby incorporated by reference, which are the subject of this Agreement. 11. Jurisdiction A. The parties agree to the commencement and conclusion of this cause of action by issuance of this Agreement, as prescribed by EPA s Consolidated Rules of Practice Governing the Administrative Assessment of Civil Penalties, 40 C. F. R. Part 22. B. Respondents agree that Complainant has the jurisdiction to bring an administrative action, based upon the facts which Respondents disclosed, for these violations and for the assessment of civil penalties pursuant to EPCRA 6 325,42 U. S. C. $ 11045; CWA 311, 33 U. S. C. $ 1321; CAA 113,42 U. S. C. 7413; RCRA 0 3008,42 U. S. C. $ 6928; and RCRA 9 9006,42 U. S. C. $ 6991e. C. Respondents hereby waive their right to request a judicial or administrative hearing on any issue of law or fact set forth in the Agreement and their right to appeal the proposed Final Order accompanying this Agreement. D. For purposes of this proceeding, Respondents admit that EPA has jurisdiction over the subject matter which is the basis of this Agreement. E. Respondents neither admit nor deny the statements of fact or conclusions of law as set forth in this Agreement. F. This Agreement serves as the Notice of Violation required by § 113( a)( l) of the CAA, 42 U. S. C. 7413( a)( l). Complainant will also notify the appropriate States by providing a copy of this Agreement, in accordance with CAA 113( a)( l). G. Respondents have been afforded the opportunity to confer with EPA asprovided for by CAA § 113( a)( 4), 42 U. S. C. § 7413( a)( 4). I­ H. Complainant has provided notice of this action and a copy of this Agreement to the affected States, in accordance with CWA 309,33 U. S. C. 1319, and RCRA 3008( a)( 2), 42 U. S. C. 6928( a)( 2). 111. Statements of Fact A. Respondents, Nextel Communications, Inc., its subsidiaries, and NII Holdings, Inc., are telecommunications companies incorporated in the States noted on Attachment A. 2 B. Pursuant to the EPA s Audit Policy, Respondents hereby certify and warrant as true the facts referenced in this Section, and EPA accepts Respondents certification. In addition, with respect to CAA tj 110,42, U. S. C. 4 7410, and the requirements adopted as part of the SIPs for the various States, Air Districts or Counties with jurisdiction over the violations found in Attachment B, Respondents have certified that they have applied for permits, andor taken all actions needed to comply with such requirements, but for some facilities are awaiting final determination on such actions by each respective State, Air District or County. EPA believes that, for the purposes of this Agreement, Respondents have taken all necessary steps to obtain such permits and/ or actions required, and upon approval by each State, Air District or County will be in compliance with the CAA requirements, as more fully described in Attachment B. As such, Respondents specifically certify to the following facts upon which this Agreement is based: .1. the violations were discovered through an audit or through a compliance management system reflecting due diligence in preventing, detecting and correcting violations; 2. the violations were discovered voluntarily; 3. the initial violations were disclosed to EPA within 2 1 days of discovery, and in writing; subsequent disclosures were dso prompt and in writing; 4. the violations were disclosed prior to commencement of an agency inspection or investigation, notice of a citizen suit, filing of a complaint by a third party, reporting of the violations by a whistle blower employee, or imminent discovery by a regulatory agency; 5. the violations have been corrected and the Respondents are, to the best of their knowledge and belief, in full compliance with EPCRA § $ 302­ 303, $ 9 3 11­ 312, 42 U. S. C. $ 5 11002­ 1 1003, $ 0 11021­ 11022; CWA $ 31I( i)( l)( C), 33 U. S. C. 0 13210)( 1)( C); CAA 9 110,42 U. S. C. 9 7410 and the requirementsadopted as part of the SIPS; RCRA 3 3002,42 U. S. C: 9 6922; and RCRA $ 9 9002­ 9003,42 U. S. C. $ 9 699 1a­ 6991b, and the implementing regulations with respect to the violations set forth in this Agreement; ­._ p 6. appropriate steps have been taken to prevent a recurrence of the violations; 7. Respondents have no knowledge that violations other than those covered in this Agreement ( or closely related violations), have occurred within the past three years at the same facilities; nor are the specific violations that are the subject of this Agreement part of a pattern of violations by Respondents which have occurred over the past five years; 8. the violations have not resulted in serious actual harm nor presented an imminent and substantial endangerment to human health or the environment and they did not 3 violate the specific terms of any judicial or administrative Final Order or Agreement; and 9. Respondents have cooperated as requested by the EPA. IV. Conclusionsof Law EPCRA A. For purposes of this Agreement, Respondentsare persons as defined in EPCRA tj 329( 7), 42 U. S. C. tj 11049( 7), and are the owner or operator of facilities asdefined in EPCRA tj 329( 4), 42 U. S. C. 6 11049( 4). B. Section 302( c) of EPCRA, 42 U. S. C. 0 11002( c), and the regulations found at 40 C. F. R. Part 355, require owners and operators of facilities at which an extremely hazardous substance is present, at or above stated designated threshold planning quantities ( TPQs), as defined in 40 C. F. R. Part 355, to notify the State Emergency Response Commission( SERC) that such facility is subject to the requirements of $ 302( c). C. Section 303( d) of EPCRA, 42 U. S. C. 5 11003( d), and the regulations found at 40 C. F. R. Part 355, require owners and operators of facilities at which an extremely hazardous substance is present, at or above stated designatedTPQs, to notify the Local Emergency Planning Committee ( LEPC) of the facility representative who will participate in the emergency planning process as a facility emergency coordinator. D. Section 31l( a) of EPCRA, 42 U. S. C. 5 11021( a), and the regulations found at 40 C. F. R. Part 370, require the owner or operator of a facility, which is required to prepare or have available a material safety data sheet ( MSDS) for a hazardous chemical under the Occupational Safety and Health Act of 1979,29 U. S. C. A. 6 651 et. seq., ( OSH Act) and regulations promulgated under the Act, and has substancespresent in excess of certain stated designated threshold quantities, as defined in Section G below, to submit the MSDS, or in the alternative, a list of chemicals to the LEPC, the SERC, and to the fire departmentwith jurisdiction over the facility by October 17, 1987, or within three months of first becoming subject to the 6 311 requirements. Ef Section 312( a) of EPCRA, 42 U. S. C. tj 11022( a), adthe regulations found at 40 C. F. R. Part 370, require the owner or operator of a facility which is required to have an MSDS for a hazardous chemical under the OSH Act of 1979,29 U. S. C. A. 6 65 1 et. seq., and regulations promulgated under the OSH Act, and has substancespresent in excess of certain stated designated threshold quantities, as defined in Section G below, to prepare and submit an emergency and hazardous chemical inventory form ( Tier I or Tier I1 as described in 40 C. F. R. Part 370) containing the informationrequired by those sections to the LEPC, SERC, and to the fire department with jurisdiction over the facility by March 1, 1988, ( or March 1 of the first year after the facility first becomes subject to the tj 312 requirements), and annually thereafter. 4 F. Diesel fuel, heptaflouropropane and ethylene glycol are hazardous chemicals , and sulfuric acid is an extremely hazardous substance, as defined under 9 312 of EPCRA and 40 C. F. R. 9 370.2. G. As set forth in 40 C. F. R. 9 370.20, the threshold amount for reporting pursuant to Sections 31l( a) and 3 12( a) of EPCRA for hazardous chemicals present at a facility at any one time during the preceding calendar year is ten thousand ( 10,000) pounds. The reporting threshold under Sections 31l( a) and 312( a) of EPCRA, therefore, for diesel fuel, heptaflouropropane and ethylene glycol, is ten thousand ( 10,000) pounds. For extremely hazardous substances present at the facility, the threshold amount for reporting pursuant to Sections 3 1l( a) and 312( a) of EPCRA is five hundred ( 500) pounds or the TPQ, whichever is lower. The TPQ for sulfuric acid is one thousand ( 1,000) pounds. The reporting threshold for sulfuric acid, therefore, is five hundred ( 500) pounds. H. The information supplied by the Respondents in their self­ disclosure indicated that for varying lengths of time during calendar years 1997­ 2002, Respondents had the hazardous chemicals, diesel fuel, heptaflouropropane and ethylene glycol, and/ or an extremely hazardous substance, sulfuric acid, in excess of the threshold amounts, present at its facilities listed in Attachment B. I. For purposes of this Agreement, Complainant hereby states and alleges that, based on the information supplied by Respondents to EPA, Respondents have violated the following requirements : 1. EPCRA 9 302( c), 42 U. S. C. 9 11002( c), and the regulations found at 40 C. F. R. Part 355 when they failed to notify the SERC at seventy­ two ( 72) facilities, identified in Attachment B; 2. EPCRA 6 303( d), 42 U. S. C. 9 11003( d), and the regulations found at 40 C. F. R. Part 355 when they failed to notify the LEPC of the identity of the emergency coordinator who would participate in the emergency planning process at seventy­ two ( 72) facilities, identified in Attachment B; ­.>­ 3. EPCRA 9 31l( a), 42 U. S. C. 0 11021( a) and the regulations found at 40 C. F. R. Part 370, when they failed to submit an MSDS for Kh­ iizkdous chemical( s) or, in the alternative, a list of such chemicals, for seventy­ five ( 75) facilities, to the LEPC, SERC, and the fire department with jurisdiction over these facilities, identified in Attachment B; 4. EPCRA 9 312( a), 42 U. S. C. 9 11022( a) and the regulations found at 40 C. F. R. Part 370 at sixty­ six ( 66) facilities, by failing to prepare and submit emergency and chemical inventory forms to the LEPC, the SERC and the fire department with jurisdiction over each facility, identified in Attachment B. 5 CWA A. For purposes of this Agreement, Respondents are persons within the meaning of CWA Q 31 l( a)( 7), 33 U. S. C. 5 1321( a)( 7), and 40C. F. R. 5 112.2, and are the owners or operators , as defined by CWA Q 3 1l( a)( 6), 33 U. S. C. 9 1321( a)( 6), and 40C. F. R. 5 112.2, of the forty­ eight ( 48) facilities, described more fully in Attachment B. B. The regulations at 40C. F. R. 0 112.3 through Cj 112.7, which implement $ 3 11( i)( 1)( C) of the CWA, 33 U. S. C. 5 13210)( 1)( C), set forth procedures, methods and requirementsto prevent the discharge of oil from non­ transportation­ relatedfacilities into or upon the navigable waters of the United States and adjoining shorelines in such quantities that by regulation have been determined may be harmhl to the public health or welfare or environment of the United States by owners or operators who are engaged in drilling, producing, gathering, storing, processing, refining, transferring, distributing or consuming oil or oil products. C. 40 C. F. R. $ 112.3( a) requires owners and operators of onshore and offshore facilities that have discharged or due to their location, could reasonably be expected to discharge oil in harmful quantities into or upon the navigable waters of the United States or adjoining shorelines, to prepare a Spill Prevention Control and Countermeasure ( SPCC) Plan. D. Respondents are engaged in storing or consuming oil or oil products for backup generators located at the forty­ eight ( 48) facilities, described in Attachment B, in quantities that may be harmful, as defined by 40 C. F. R. $ 110.3. E. Forty­ eight ( 48) of Respondents facilities, described in Attachment B, are onshore facilities within the meaning of CWA 5 31l( a)( lO), 33 U. S. C. 5 1321( a)( 10) and 40 C. F. R. 9 112.2, which, due to their location, could reasonably be expected to discharge oil into navigable waters of the United States, as defined by CWA 9 502(?), 33 U. S. C. 6 1362( 7), and 40 C. F. R. 3 110.1, or its adjoining shoreline, that may either ( 1) violate applicablewater quality standards or ( 2) cause a film or sheen or discolorationof the surface of the water or adjoining shorelines or cause a sludge or emulsionto be depositedbeneath the surface of the water or upon adjoining shorelines. F. Based on the above, and pursuant to 3 31lQ)( l)( C) and its implementingregulations, ­ Respondentsare subject to the requirements of 40C. F. R. 8 1 12.3through Q 112.7, at the forty­ eight ( 48) facilities listed in Attachment B, hereby incorporated by reference. G. For purposes of this Agreement, Complainanthereby states and alleges that, based on the information supplied by Respondentsto EPA, Respondents have violated the CWA at forty­ eight ( 48) facilities identified in Attachment B, by failing to prepare and/ or implement an SPCC Plan, as required by CWA $ 31 l( j)( l)( C), 33 U. S. C. 1321( i)( l)( C), and the regulations found at 40 C. F. R. 0 112.3 through Q 112.7. 6 A. For purposes of this Agreement, Respondents are persons within the meaning of CAA, $ 302( e), 42 U. S. C. 6 7602( e) and operate stationary source withinthe meaning of 9 302( z), 42 U. S. C. 6 7602( z). B. Section 1 lO( a)( l) of the CAA, 42 U. S. C. 9 7410( a)( l), requires a State to submit an implementation plan, commonly known as a state implementation plan ( SIP) to implement, maintain and enforce ambient air quality standards. C. The following States, in which Respondents facilities are located, submitted SIPS, which were approved by EPA under 5 110 of the CAA, 42 U. S. C. 6 7410, on the following dates: i. Maricopa County Environmental Services Department, Air Quality Division: 37 Fed. Reg. 15,080 ( July 27, 1972) ii. South Coast Air Quality Management District: 43 Fed. Reg. 52,237 ( Nov. 9, 1978) iii. San Joaquin Valley Air Pollution Control District: 64 Fed. Reg. 39,920 ( July 23,1999) iv. Kansas: 60 Fed. Reg. 36,361 ( July 17, 1995) v. New Jersey: 37 Fed. Reg. 10,880 ( May 3 1,1972), 5 1 Fed. Reg. 42,565 ( Nov. 25, 1986) vi. Pennsylvania: 38 Fed. Reg. 32,893 ( Nov. 28,1973), as amended at 45 Fed. Reg. 33,627 ( May 20, 1980); 51 Fed. Reg. 18,840 ( May 20, 1986); 53 Fed. Reg. 3 1,330 ( Aug. 18, 1988); 59 Fed. Reg. 30,304 ( June 13, 1994); 60 Fed. Reg. 47,085 ( Sept. 11,1995); 6 1 Fed. Reg. 16,062 ( April 11,1996); 63 Fed. Reg. 13,794 ( March 23,1998); 63 Fed. Reg. 23,673 ( April 30,1998) D. For purposes of this Agreement, Complainant hereby states and alleges that, based on the 2 information supplied by Respondents to EPA, Respondents have violated a SIP requirement at eight ( 8) facilities. The requirements and the facilities are listed in Attachment B, hereby incorporated by reference. RCRA ­ HAZARDOUS WASTE A. Respondents are persons within the meaning of RCR4 9 1004( 15), 42 U. S. C. 0 6903( 15), and are the operators of the facility designated as VA­ 8 in Attachment B, within the meaning of 9 Virginia Administrative Code ( VAC) 20­ 60­ 260( A), [ 40 C. F. R. $ 260.101. Respondents are also generators of hazardous waste at VA­ 8, within the meaning of 9 VAC 20­ 60­ 260( A), [ 40 C. F. R. 9 260. lo]. Because Respondents generate less than one hundred 7 kilograms of hazardous waste in a month at VA­ 8, Respondents qualify as a conditionally exempt small quantity generator and are therefore subject to the requirements of 9 VAC 20­ 60261 A), [ 40 C. F. R. $ 261.51. B. Section 3006 of RCRA, 42 U. S. C. § 6926, provides that States may be authorized to issue and enforce permits for the storage, treatment and disposal of hazardous waste, and to administer EPA­ authorized hazardous waste programs within their State. Virginia, where VA­ 8 is located, has been authorized to administer its own hazardous waste programs. Virginia has incorporated by reference the federal requirements found at 40 C. F. R. Part 260 through 270 at 9 VAC 20­ 60­ 260 through 270. C. Pursuant to RCRA 6 3006( g), 42 U. S. C. 6926( g), and f3 3008( a) and ( g), 42 U. S. C. 3 6928( a) and ( g), EPA may enforce the federally approved state hazardous waste programs, as well as the federal regulations promulgated pursuant to the Hazardous and Solid Waste Amendments. D. In order for a conditionally exempt small quantity generator ( CESQG) to be exempt fiom full regulation, they must comply with 9 VAC 20­ 60­ 261( A), [ 40 C. F. R. Q 261.5( g)] which lists three requirements. First, the CESQG must comply with9 VAC 20­ 60­ 262( A), [ 40 C. F. R. tj 262.1 13 and make a hazardous waste determination. Second, the waste may only accumulate for a specified time period. Finally, the waste must be treated on­ site or delivered to an off­ site treatment, storage or disposal facility as defined by 9 VAC 20­ 60­ 26 1( A), [ 40 C. F. R. $ 261S( g)( 3)( i)­( vii)]. E. Respondents deactivated six squibs, a small explosive placed in airplane fire extinguishers, in a single event in 1998. The squibs were generated at VA­ 8. Squibs are regulated as a hazardous waste. since they are a reactive waste defined by 9 VAC 20­ 60­ 26 1( A) [ 40 C. F. R. 6 261.23( a)( 6)]. F. Based on information provided by Respondents, Respondents violated 9 VAC 20­ 60 261( A), [ 40 C. F. R. 0 261.5( g)( 1)] when they failed to makea hazardous waste determination on the squibs and 9 VAC 20­ 60­ 261( A), [ 40 C. F. R. 261.5( g)( 3)] when they improperly disposed of the squibs by detonating them. RCRA ­ FINANCIAL ASSURANCE A­ A. For purposes of this agreement, Respondents are persons within the meaning of RCRA $ 9001( 6), 42 U. S. C. $ 6991( 6), and 40 C. F. R. $ 280.12. B. For purposes of this agreement, Respondents are the operators, as defined in RCRA 0 9001( 4), 42 U. S. C. 6991( 4), 40 C. F. R. 6 280.12, of four underground storage tank ( UST) systems, as defined in RCRA 6 9001( 1), 42 U. S. C. $ 6991( 1), 40 C. F. R. 0 280.12, and 30 Texas Administrative Code ( TAC) 5 334.2, identified in Attachment B. 8 . C. Pursuant to RCRA $ 9 9002­ 9003,42 U. S. C. $ 9 6991a ­ 6991b, EPA, and the State of Texas promulgated rules pertaining to owners and operators of UST Systems, set forth at 40 C. F. R. Part 280 and 30 TAC $ 9 334 and 37. D. Section 9003( d) of RCRA, 42 U. S. C. 9 6991b( d) requires owners or operators of UST systems to obtain UST insurance policies that must be worded according to the format set forth in 40 C. F. R. 3 280.97 and 30 TAC $ 37.801. E. For purposes of this Agreement, Complainant hereby states and alleges that, based on the information supplied by Respondents to EPA, Respondents have violated RCRA $ 9003( d), 42 U. S. C. 0 6991b( d), 40 C. F. R. $ 280.97 and 30 TAC $ 9 334 and 37.801, when the insurance policy failed to use the terms corrective action or sudden, non­ sudden or accidental release to describe coverage for the four ( 4) facilities listed in Attachment B. RCRA ­ UST ( Philadelphia) A. For purposes of this agreement, Respondents are persons within the meaning of RCRA 5 9001( 6), 42 U. S. C. § 6991( 6), and 40 C. F. R. 9 280.12. B. For purposes of this agreement, Respondents are the owners , as defined in RCRA 5 9001( 3), 42 U. S. C. 5 6991( 3), 40 C. F. R. 5 280.12, of one underground storage tank ( UST) system, as defined in RCRA 9 9001( 1), 42 U. S. C. 6 6991( 1), 40 C. F. R. tj 280.12, at their Philadelphia facility, identified in Attachment B. C. Pursuant to RCRA $ 8 9002­ 9003,42 U. S. C. $ 9 6991a ­ 6991b, EPA promulgated rules pertaining to owners and operators of UST systems, set forth at 40 C. F. R. Part280. D. Section 9003 of RCRA, 42 U. S. C. 96991b and 40 C. F. R. Part 280 set forth all relevant regulations for owners or operators of UST systems including release detection, prevention, and financial assurance. E. Respondents had a storage tank at the Philadelphia facility that was determined to be an UST because it was surrounded by an earthen material, Le., sand. T. Pursuant to RCRA $ 9002( a), 42 U. S. C. $ 6991a( a), the owner of an UST shall notify the State or local agency or department designated pursuant to 5 9002( b)( 1) of the existence of such tank by May 8,1986. Pursuant to 40 C. F. R. $ 280.22( a) any owner who brings an UST system into use after May 8, 1996, must within 30 days of bringing such tank into use, submit a notice of existence of such tank system to the state or local agency or department designated to receive such notice. G. For purposes of this Agreement, Complainant hereby states and alleges that, based on the information supplied by Respondents to EPA, Respondents have violated the following requirements: 9 1. RCRA 0 9002( a)( l), 42 U. S. C. 0 6991( a)( 1), and the regulations found at 40 C. F. R. 9 280.22( a) when they failed to notify the state at one ( 1) facility, identified in Attachment B. 2. RCRA 0 9003,42 U. S. C. 0 6991b, and all of the relevant UST regulations found at 40 C. F. R. tj 280 for the one ( 1) facility identified in Attachment B; V. Civil Penaltv A. EPA agrees, based upon the facts and information submitted by Respondents and upon Respondents certification herein to the veracity of this information, that Respondents have satisfied all of the conditions set forth in the Audit Policy and thereby qualifies for a 100% reduction of the gravity component of the civil penalty. Complainant alleges that the gravity component of the civil penalty is $ 1,553,747. Of that penalty, $ 1,160,622 is attributableto EPCRA violations; $ 220,000 is attributableto CAA violations; $ 137,500 is attributable to CWA violations; and $ 35,625 is attributable to RCRA violations. EPA alleges that this gravity component is assessable against Respondents for the violations that are the basis of this Agreement. B. Under the Audit Policy, EPA has discretion to assess a penalty equivalent to the economic benefit Respondents gained as a result of their noncompliance. Based on information provided by Respondents and use of the Economic Benefit ( BEN) computer model, EPA has determined that Respondents obtained an economic benefit of $ 35,004 as a result of their noncompliance in this matter. Of this amount, $ 7,581 is attributable to the EPCRA violations; $ 1,136 is attributable to the CAA violations; $ 21,458 is attributable to CWA violations; and $ 4,829 is attributable to the RCRA violations. Accordingly, the civil penalty agreed upon by the parties for settlement purposes is $ 35,004. VI. Terms of Settlement A. Respondents agree to pay THIRTY­ FIVE THOUSAND AND FOUR DOLLARS ($ 35,004), in satisfaction of the civil penalty. B. For payment of the civil penalties related to EPCRA, CAA, and RCRA, Respondents ­ .& all send, within thirty ( 30) days of issuance of the Final­ Order; a cashier s check or certified check in the amount of THIRTEEN THOUSAND, FIVE HUNDRED AND FORTY­ SIX DOLLARS ($ 13,546), made payable to the Treasurer of the United States of America, to the following address: United States Environment Protection Agency Hearing Clerk P. O. Box 360277M Pittsburgh, PA 15251 10 The check should indicate that it is for In re: Nextel Communications, Inc., et. al. and NII Holdings, Inc., Docket No. EPCRA­ HQ­ 2002­ 6001, CAA­ HQ­ 2002L6001, and RCRA­ HQ2002 6001. Alternatively, Respondents shall pay THIRTEEN THOUSAND, FIVE HUNDRED AND FORTY­ SIX DOLLARS ($ 13,546) by wire transfer with a notation of Nextel Communications, Inc., et. al, and NII Holdings, Inc., Docket No. EPCRA­ HQ­ 2002­ 6001, CAA­ HQ­ 2002­ 600 1, and RCRA­ HQ­ 2002­ 600 1 by using the following instructions: Name of Beneficiary: EPA Number of Account for deposit: 68010099 The Bank Holding Account: Treas NYC The ABA routing Number: 021030004 C. In payment of the civil penalty related to CWA, Respondents shall, withinthirty( 30) days of issuance of the Final Order, forward a cashier s or certified check, in the amount of TWENTY­ ONE THOUSAND AND FOUR HUNDRED AND FIFTY­ EIGHT DOLLARS, ($ 21, 458), made payable to the Oil Spill Liability Trust Fund, to: Commander, National Pollution Funds Center United States Coast Guard Ballston Common Office Building Suite 1000 4200 Wilson Boulevard Arlington, VA 22203 The check should indicate that it is for In re: Nextel Communications, Inc., et. al.. and NII Holdings. Inc., Docket No. CWA­ HQ­ 2002­ 6001. Alternatively, Respondents shall pay TWENTY­ ONE THOUSAND AND FOUR HUNDRED AND FIFTY­ EIGHT DOLLARS, ($ 21,458) by wire transfer with a notation of Nextel Communications, Inc., et. al., and NII Holdings, Inc., Docket No. CWA­ HQ­ 2002­ 6001 by using the following instructions: ­ > Bank s ABA Number: 02103U004 Treas NYC Coast Guard BeneficiaryNumber: 69025102 Type/ Subtype Code: 10 00 D. Respondents shall forward copies of these checks or evidence of wire transfer to EPA, within five ( 5) days of payment, to the attention of: 11 ­­ Elizabeth Cavalier Multimedia Enforcement Division ( 2248­ A) Office of Enforcement and Compliance Assurance U. S. Environmental Protection Agency 1200 PennsylvaniaAve, N. W. Ariel Rios Building, Room 3119A Washington, DC 20460 and Clerk, EnvironmentalAppeals Board U. S. EnvironmentalProtection Agency MC 1103B 1200 PennsylvaniaAve., NW Washington, DC 20460 E. Respondents obligations under this Agreement shall end when they have paid the civil penalties as required by this Agreement and the Final Order, and in accordance with Section VI@) and ( C), and complied with its obligations under SectionVI( D) of this Agreement. F. For the purposes of state and federal income taxation, Respondents shall not be entitled, and agree not to attempt, to claim a deduction for any civil penalty payment made pursuant to the Final Order. Any attempt by Respondentsto deduct any such payments shall co&& ute a violation of the Agreement. G. Pursuant to 31 U. S. C. $ j3717, EPA is entitled to assess interest and penalties on debts owed to the United States and a charge to cover the cost of processing and handling a delinquent claim. Interest will therefore begin to accrue on the civil penalty fkom the date of entry of the Final Order, if the penalty is not paid by the date required. Interest will be assessed at the rate of the United States Treasury tax and loan rate in accordancewith 40 C. F. R. 9 13.11. A charge will be assessed to cover the costs of debt collection, including processing and handling costs and attorney fees. In addition, a penalty charge of twelve ( 12) percent per year compounded annually will be assessed on any portion of the debt that remains delinquent more than ninety ( 9.0) days after payment is due. VII. Public Notice A. The parties acknowledgethat the settlementportions of this Agreement which pertain to the CWA violations are, pursuant to CWA 9 31 1( 6)( C)( i), 33 U. S. C. 9 1321( 6)( C)( i), subject to public notice and comment requirements. Furthermore, the parties acknowledgeand agree that at that time, EPA will also provide an opportunityto comment on the EPCRA, CAA, and RCRA portions of this Agreement. Should EPA receive comments regarding the issuance of the Final Order assessing the civil penalty agreed to in Paragraph VI( A), EPA shall forward all such comments to Respondents within ten ( 10) days of the receipt of the public comments. 12 B. As part of this Agreement, and in satisfactionof the requirements of the Audit Policy, Respondents have certified to certain material facts. The parties agree that should EPA receive, through public comments or in any way, informationthat proves or demonstrates that these material facts are other than as certified by Respondents, the portion of this Agreement pertaining to the affected facility or facilities, includingmitigation of the proposed penalty, may be voided, or this entire agreement may be declared null and void at EPA s election prior to the issuance of the Final Order, and EPA may proceed with an enforcement action. C. The parties agree that the Respondents preserve all of their rights should this Agreement be voided in whole or in part. The parties further agree that Respondents obligations under this Agreement will cease should this Agreement be rejected by the EnvironmentalAppeals Board. VIII. Reservation of Rights and Settlement A. This Agreement and the Final Order, when issued by the EAB, and upon payment by Respondents of civil penalties in accordance with Section VI, shall resolve only the civil claims specified in Attachment B and shall constitute a final and complete settlement of all federal civil and administrative claims bd causes of action arising from the violations specified in Attachment B, and the facts alleged in Section IV. Nothing in this Agreement and the Final Order shall be construed to limit the authority of EPA and/ or the United States to undertake any action against Respondents, in response to any condition which EPA or the United States determines may present an imminent and substantialendangerment to the public health, welfare, or the environment. Furthermore, issuance of the Final Order does not constitute a waiver by EPA and/ or the United States of its right to bring an enforcement action, either civil or criminal, against Respondents for any other violation of any federal or state statute, regulation or permit. IX. Other Matters A. Each party shall bear its own costs and attorney fees in this matter. B. The provisions of this Agreement and the Final Order, when issued by the EAB, shall apply to and be binding on the Complainant, and the Respondents, as well as Respondents afficers, agents, successors and assigns. Any change in omership or corporate status of the Respondents including, but not limited to, any transfer of assets or real or personal property shall not alter Respondents responsibilities under this Agreement, including the obligation to pay the civil penalty referred to in Paragraph V@). C. Nothing in this Agreement shall relieve Respondents of the duty to comply with all applicableprovisions of the EPCRA, CAA, CWA, and RCRA or other federal state or local laws or statutes, nor shall it restrict EPA s authority to seek compliance with any applicable laws, nor shall it be construed to be a ruling on, or a determinationof, any issue related to any federal, state or local permit. 13 D. Except as provided in Section VII( C), Respondents waive any rights they may have to contest the allegations contained herein and its right to appeal the proposed Final Order accompanying this Agreement by reference. E. Although EPA is not requiring submission of inventory forms for previous reporting cycles, i. e., before reporting year 2000, in order to settle thismatter, Respondents agree to contact, if they has not already done so, the SERC, or the equivalent entity delegated the authority specified in EPCRA $ 301,42 U. S. C. $ 11001, for each State in which a facility is alleged to be in violation to determine whether submission of previous years of EPCRA $ 3 12 inventory forms is required. This Agreement does not preclude or limit any state action regarding filing fees which may be owed or any other state action regarding Respondents obligations under state law. F. The undersigned representatives of each party to this Agreement certify that each is duly authorized by the party whom he represents to enter into these terms and bind that party to it. FOR Respondents ( Except NII Holdings, Inc.): L. 23, LOoL Senior Vice President and General Counsel Nextel Communications, Inc., et. a1 FOR Respondents NII Holdings, Inc.: ­\ Vice Prdent and General Counsel NII Holdings, Inc. FOR Complainant: Dat Acting Director Mulitmedia Enforcement US. Environmental Protection Agency 14 ­­ BEFORE THE ENVIRONMENTAL APPEALS BOARD UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. IN THE MATTER OF: NEXTEL Communications, Inc., et. a1 2001 Edmond Halley Dr. Reston, Virginia 20 191 NII Holdings, Inc. 10700 Parkridge Blvd Suite 600 Reston, Virginia 20191 Respondents 1 1 1 ) 1 ) ) 1 ) 1 FINAL ORDER Docket No. EPCRA­ HQ­ 2002­ 6001 Docket No. CWA­ HQ­ 2002­ 6001 Docket No. CAA­ HQ­ 2002­ 6001 Docket No. RCRA­ HQ­ 2002­ 6001 Whereas Complainant, the United States Environmental Protection Agency, and Respondents, Nextel Communications, Inc., its subsidiaries and NII Holdings, Inc., identified in the Consent Agreement, the Parties herein, represented by counsel, have consented to the entry of this Final Order, and agree to comply with the Consent Agreement signed by the parties and incorporated herein; and Whereas EPA caused a Notice for Public Comment on the proposed issuance of this Final Order to be published in the Federal Register on 2002, asrequired by the Clean Water ­. s. Act 5 3 11( b)( 6), 33 U. S. C. tj 1321( b)( 6), the public notice and comment period required has closed, and no comments have been received; The Consent Agreement is hereby approved and incorporated by reference into this Final Order. The Respondents are hereby ordered to comply with the terms of the Consent Agreement, effective immediately. SO ORDERED. By: Date: Environmental Appeals Judge Environmental Appeals Board US EPA L­ ATTACHMENT A NEXTEL Subsidiarieswhich are parties to this agreement: Nextel Finance Company 2001 Edmund Halley Drive Reston, Virginia 20191 Nextel Operatiom, Inc. 2001 Edmund Halley Drive Reston, Virginia 20191 Nextel Systems Corp. 2001 Edmund Halley Drive Reston, Virginia 20191 Domestic USF Corp. 2001 Edmund Halley Drive Reston, V i20191 Nextel Aviation, Inc. 2001 Edmund Halley Drive Reston, Vi@ 20191 NII Holdings, Inc. 10700 parkridge Blvd. Suite600 Reston, Virginia 20191 Nextel West Corp. 27755 Stansbury Blvd. FarmingtOn Hills, Michigan 48334 Nextel South Corp. 851 Trafalgar Court, Suite 300­ E Maitland, Florida 32751 Nextel of California, Inc. 1255 Treat Blvd., Suite 800 Walnut Creek, California 945% ' IIJgtelCommunicationsof the Mid­ Atlantic, Inc. 4340 East WestHighway, Suite 800 Bethesda, Maryland 20814 Nextel of New York, Inc. 565 Taxter Road Elmsford, New York 10523 Nextel of Texas, lnc. Franklin Plaze 111 Congress Avenue, 7"' Floor Austin. Texas 78701 Stateof Incorporation Delaware Delaware Delaware Delaware Delaware Delaware Delaware Georgia Delaware Delaware Delaware Texas A:\ amch a 2 from Irn. doc gxg W 0 R ; D a D D < W 08; F N' N. ­ I g: N m Y: 8: a 1. I W m m P W I ul m n n 0 n D P W . . : I ­ 4 m

epa

2024-06-07T20:31:41.120097

regulations

EPA-HQ-OEI-2002-0001-0001

Notice

EPA Dockets; EPA's New Electronic Public Docket and Comment System; Notice of Availability

38102 Federal Register / Vol. 67, No. 105 / Friday, May 31, 2002 / Notices Summary: No formal comment letter was sent to the preparing agency. ERP No. DS– NPS– J61102– 00 Rating EO2, Yellowstone and Grand Teton National Parks and John D. Rockefeller, Jr., Memorial Parkway, Winter Use Plans, Updated and New Information on New Generation of Snowmobiles that Produce fewer Emissions and are Quieter, Fremont County, ID; Gallatin and Park Counties, MT and Park and Teton Counties, WY. Summary: EPA expressed environmental objections based on the potential adverse impacts from three action alternatives, 1b, 2 and 3 which could result in noncompliance with air quality standards and potential adverse impacts on human health. Final EISs ERP No. F– AFS– B65009– NH Loon Mountain Ski Resort Development and Expansion Project, Implementation, Special Use Permit and NPDES Permit Issuance, White Mountain National Forest, Pemgewasset Ranger District, Grafton County, NH. Summary: EPA expressed environmental concerns about growth impacts and associated mitigation and made recommendations about hydrogeologic and air quality issues. ERP No. F– FHW– E40781– TN I– 40 Transportation Improvements from I– 75 to Cherry Street in Knoxville, Funding, NPDES and US Army COE Section 404 Permits Issuance, Knox County, TN. Summary: EPA continues to have environmental concerns regarding noise and cultural resources impacts. EPA supports the construction of noise barriers that were proposed but were not committed to be constructed. Dated: May 28, 2002. Joseph C. Montgomery, Director, NEPA Compliance Division, Office of Federal Activities. [FR Doc. 02– 13691 Filed 5– 30– 02; 8: 45 am] BILLING CODE 6560– 50– P ENVIRONMENTAL PROTECTION AGENCY [OEI– 2002– 0001; FRL– 7181– 7] EPA Dockets; EPA's New Electronic Public Docket and Comment System; Notice of Availability AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA is announcing the availability of a new electronic public docket and comment system designed to greatly expand access to EPA's public dockets, and facilitate the submission of public comments to EPA, providing an unprecedented level of online access to EPA's programs and rulemaking processes. Known as EPA Dockets, this online system will allow you to search the Agency's major public dockets online, view the index listing of the contents for the dockets included in the system, and access those materials that are available online. You will be able to submit your comments online when a particular public docket available in EPA Dockets is open for public comments, and you will be able to view public comments online for that docket. This new capability will be a valuable tool to support the Agency's regulatory process by enabling more efficient access to EPA's rulemaking development process, and will create a new means for the Agency to share other non­ rulemaking information for comment purposes. This capability will enable Agency rulemakers and decisionmakers to carry out their responsibilities more efficiently. It will greatly enhance the public's access to the materials used in EPA's decision­ making process, simplify electronic commenting, and access to the public comments in those public dockets available in EPA Dockets. This document provides a brief introduction to EPA Dockets, along with an overview of EPA's policies related to the implementation of the system. FOR FURTHER INFORMATION CONTACT: Shivani Desai, Information Strategies Branch, Collection Strategies Division (Mail Code 2822T), Office of Environmental Information (OEI), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 566– 1674; fax number: (202) 566– 1639; e­ mail address: desai. shivani@ epa. gov. SUPPLEMENTARY INFORMATION: I. Background Electronic government is a core component of the President's Management Agenda with stated goals to: Make it easy for citizens to obtain service and interact with the federal government; improve government efficiency and effectiveness; and improve government's responsiveness to citizens. With those goals in mind, twenty­ four projects with the most potential to simplify and unify agency processes and information flows, provide one­ stop services to citizens and increase agency effectiveness were identified by the Office of Management and Budget (OMB) for implementation. One of those projects, On­ Line Rulemaking, will create an easy­ to­ use, government­ wide on­ line portal to find and comment on proposed rules. The project will ultimately improve quality, efficiency, and consistency in the federal rulemaking processes. EPA Dockets is consistent with the approach contained in the On­ Line Rulemaking project and can serve as an important building block for development. More information regarding the projects included in the President's Management Agenda for E­ gov can be obtained from the federal government's E­ Government Strategy on the OMB website at http:// www. whitehouse. gov/ omb/ inforeg/ egovstrategy. pdf. There are also several statutory mandates for federal agencies to provide electronic access to agency information. For example, the Government Paperwork Elimination Act (GPEA), Public Law 105– 277, Title XVII (1998), mandates that agencies give citizens the option to submit information and conduct transactions with the agency electronically, when practicable, by October 2003. The Electronic Freedom of Information Act (E­ FOIA), Amendments of 1996, 5 U. S. C. 552( a), require agencies to ensure the electronic availability of the agency­ created records that must be available for public inspection and copying, through on­ line access where possible, or by other electronic means, and that agencies provide an electronic copy of the information if readily reproducible electronically when requested in that format. Other mandates require agencies to consider revising their operations or procedures to maximize the use of today's electronic technology. EPA initiated the development of an electronic public docket system after a 1996 survey of docket customers revealed the desire of docket customers to have electronic access to docket materials and the ability to search across all of the EPA dockets for information. Initiated prior to the online rulemaking initiative included in the President's Management Agenda for E­ gov, and before the enactment of the electronic access mandates, today's announcement of the EPA Dockets demonstrates EPA's commitment to ensuring that the public has access to the information that is used to inform the Agency's decisions regarding potential risks to the environment and public health, and that the public has an opportunity to participate in the Agency's decision process. By providing online access to EPA's public dockets, and an online mechanism for the submission of public comments, EPA is advancing the EGovernment Strategy, as well as satisfying the mandate under GPEA. VerDate May< 23> 2002 17: 37 May 30, 2002 Jkt 197001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 31MYN1. SGM pfrm15 PsN: 31MYN1 38103 Federal Register / Vol. 67, No. 105 / Friday, May 31, 2002 / Notices II. EPA's New Electronic Docket The following is a brief introduction to EPA Dockets, along with an overview of EPA's policies related to the implementation of the system. A. What is a Docket? The official docket serves as the repository for the collection of documents or information related to a particular agency action or activity. The official docket generally consists of the documents specifically referenced in the Federal Register document, any public comments received, and other information used by decision­ makers, or otherwise related to the Agency action or activity. Agencies most commonly use dockets for rulemaking actions, but dockets may also be used for various other non­ rulemaking activities, such as Federal Register documents seeking public comments on draft guidance, policy statements, information collection requests under the Paperwork Reduction Act, and other non­ rule activities. The public docket is the collection of materials in the official docket that is available for public inspection and copying. Although a part of the official docket for an action or activity, the public docket does not include Confidential Business Information (CBI) or other information whose public disclosure is restricted by statute. The Agency will continue to maintain the official docket in paper form at the EPA docket facilities established for the particular program or office, where the public docket will be made available for public inspection and copying. The public can continue to view the public dockets at the facility, as well as request a copy of the docket's index or a copy of a listed publicly available document( s). B. What is EPA Dockets? The EPA Dockets, known during the development and pilot stages as the Regulatory Public Access System (RPAS), is an online system that provides electronic access to EPA's public dockets. During the development of EPA Dockets, the system was initially intended to enhance public access to rulemaking information, so most of the public dockets that are currently available in EPA Dockets will be rulemaking dockets. However, since EPA Dockets provides an effective and efficient mechanism for the public to access electronic records and submit electronic comments, you will also notice that EPA Dockets provides electronic access to other nonrulemaking dockets. The type of docket (i. e., rulemaking docket or general docket) is clearly identified within the system. In addition, when the Agency issues a Federal Register document after today, it will specifically identify in that Federal Register document whether a docket has been established, and whether the public docket has been included in EPA Dockets, and it will identify the specific identification number assigned to that docket. 1. Which Dockets Facilities are Using EPA Dockets? EPA Dockets is being phased­ in across the Agency, starting with the following four Headquarter offices: The Office of Solid Waste and Emergency Response (OSWER), the Office of Air and Radiation (OAR), the Office of Water (OW), and the Office of Prevention, Pesticides, and Toxic Substances (OPPTS). Participation is expected to be expanded to include other EPA Headquarter offices, with the Office of Environmental Information (OEI), and the Office of Enforcement and Compliance Assurance (OECA) slated to implement the system for their dockets in the Fall of 2002. Since the Agency is phasing­ in the implementation of EPA Dockets, you will notice that not all Federal Register documents with a docket that publish after today will be included in EPA Dockets. For those offices that are already using EPA Dockets, this will occur because the docket related to that Federal Register document was already established prior to the implementation of EPA Dockets, and is therefore not available in EPA Dockets. Federal Register documents with a docket that are issued by EPA offices that have not yet implemented EPA Dockets will be included in EPA Dockets at a later date, when the system is implemented by their docket facility. In addition, EPA Dockets will provide online public access to several legacy public dockets, i. e., dockets that were originally created in paper, including dockets that were transferred to EPA Dockets from an existing electronic docket system, as well as dockets that were entered into EPA Dockets during the pilot and initial implementation stages. As of May 31, 2002, the following docket facilities will use EPA Dockets to establish the public docket, index the docket contents, and, to the extent feasible, provide the electronic version of publicly available docket materials: Air Docket; telephone number: (202) 260– 7549; e­ mail address: a­ and­ rDocket epa. gov Pesticides Docket; telephone number: (703) 305– 5805; e­ mail address: oppdocket epa. gov RCRA Docket; telephone number: (703) 603– 9230; e­ mail address: rcradocket epa. gov Superfund Docket; telephone number: (703) 603– 9232; e­ mail address: superfunddocket@ epa. gov Toxics Docket; telephone number: (202) 260– 7099; e­ mail address: oppt­ ncic@ epamail. epa. gov UST Docket; telephone number: (703) 603– 9230; e­ mail address: rcradocket epa. gov Water Docket; telephone number: (202) 260– 3027; e­ mail address: OWDocket epa. gov The following docket facilities are preparing to implement EPA Dockets later this year: OEI Docket; telephone number: (202) 566– 1677. OECA Docket; telephone number: (202) 564– 2614; e­ mail address: oeca. docket@ epa. gov EPA will consolidate all the Headquarter paper docket facilities into a `` Combined Docket Facility'' in August of 2002. This new facility will continue to be located in Washington, DC, and will provide state­ of­ the­ art technology, security, and comfort to and for the public docket user community. Prior to the opening of the `` Combined Docket Facility, '' EPA will publish a notice in the Federal Register announcing the facility's contact information. This information will also be posted on the EPA website at http:// www. epa. gov/ epahome/ dockets. htm. If you have questions about a particular docket, please contact the appropriate docket facility directly. 2. What Docket Materials will be Accessible Through EPA Dockets? The content of EPA Dockets will generally mirror that of the public docket, with a few exceptions. Since the public docket does not include CBI or other information whose public disclosure is restricted by statute, the EPA Dockets will not include any of this information. Although included in the paper public docket, EPA has determined that the following material will not be included in EPA Dockets: Material subject to copyright protection. Audio and video materials. Oversized printed materials (e. g., greater than 11 x 14 ). Other physical, three dimensional items. In addition, since the paper docket currently remains the official docket, EPA Dockets may not contain electronic copies of all of the materials that are available in the paper public docket. For example, if EPA only has access to a paper copy of a document that is included in the official docket, EPA VerDate May< 23> 2002 17: 37 May 30, 2002 Jkt 197001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 31MYN1. SGM pfrm15 PsN: 31MYN1 38104 Federal Register / Vol. 67, No. 105 / Friday, May 31, 2002 / Notices intends to scan and create an electronic copy of that document so that it can also be accessed in EPA Dockets. At times, however, the Agency may not be able to complete this conversion for all of the materials in the paper public docket. Eventually, however, EPA intends to provide electronic access to all of the publicly available docket materials through EPA Dockets, and will be working to designate EPA Dockets as the official public docket. With regard to public comments, EPA will continue to place all public comments in the public docket as EPA receives them and without change. For those comments that contain CBI, or other information whose disclosure is restricted by statute, EPA will continue to ask the commenter to provide a nonCBI version of the comment for inclusion in the public docket. For EPA Dockets, EPA's policy is that public comments will be made available for public viewing in EPA Dockets, as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA Dockets. The entire printed comment, including the copyrighted material, will be available in the paper public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA Dockets. Public comments that are mailed or delivered in paper form to the docket facility will be scanned and placed in EPA Dockets. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA Dockets. Although not all docket materials may be available electronically, you may still access paper copies of any of the publicly available docket materials through the docket facility identified in the Federal Register document. 3. How Can I Access and Use EPA Dockets? You may access EPA Dockets on the Internet at http:// www. epa. gov/ edocket. You may use EPA Dockets to access available public docket materials online, as well as submit electronic comments to EPA during the open comment period for a particular docket available in EPA Dockets. To search for an available public docket or to search for a particular docket material, the system provides two basic methods of searching to retrieve dockets and docket materials that are available in the system: `` Quick Search'' to search using a full­ text search engine, or through an `` Advanced Search, '' which displays various indexed fields such as the docket name, docket identification number, phase of the action, initiating office, date of issuance, document title, document identification number, type of document, Federal Register reference, CFR citation, etc. Each data field in the advanced search may be searched independently or in combination with other fields, as desired. Each search yields a simultaneous display of all available information found in EPA Dockets that is relevant to the requested subject or topic. You may also use EPA Dockets to submit your comments online when a particular docket available in EPA Dockets is open for public comments. The Federal Register document will identify whether a docket has been established in EPA Dockets, and will provide detailed instructions identifying the various methods that can be used to submit public comments to EPA. If the docket for the Federal Register document was established prior to May 31, 2002, it may not identify EPA Dockets as an available method for submitting electronic comments on that Federal Register document. In such cases, if you do not find that public docket in EPA Dockets, you will not be able to use EPA Dockets to submit electronic comments to that particular docket, and you will need to follow the instructions in that Federal Register document for submitting your comments to EPA. If that public docket is nonetheless available in the system, EPA encourages you to use the system to submit your electronic comments. If the Federal Register document does not discuss EPA Dockets, only those comments submitted through EPA Dockets will be available in their entirety for online viewing in EPA Dockets. Your use of EPA Dockets to submit comments to EPA electronically is EPA's preferred method for receiving comments. The system is an `` anonymous access'' system, which means EPA will not know your identity, e­ mail address, or other contact information unless you provide it in the body of your comment. EPA recommends that you include your name, mailing address, and an e­ mail address or other contact information in the body of your comment to ensure that you can be identified as the submitter of the comment, and it allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. You should continue to ensure that your comments are submitted within the specified open comment period. Comments received after the close of the comment period will be marked `` late. '' EPA is not required to consider these late comments in formulating a final decision. III. Additional Information Additional details about EPA Dockets, as well as detailed instructions and assistance for using the system, is available online. Be sure to use the feedback function to let us know about your experiences using the system. We will use that feedback to help us identify potential improvements that would better service your needs. You may also contact the person listed under FOR FURTHER INFORMATION CONTACT. List of Subjects Environmental protection, Docket, Electronic, Public comment, Records. Dated: May 22, 2002. Mark A. Luttner, Director of Information Collection, Office of Environmental Information. [FR Doc. 02– 13521 Filed 5– 30– 02; 8: 45 am] BILLING CODE 6560– 50– S ENVIRONMENTAL PROTECTION AGENCY [OPP– 2002– 0083; FRL– 7180– 7] FIFRA Scientific Advisory Panel; Notice of Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: There will be a 3– day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Food Quality Protection Act (FQPA) Scientific Advisory Panel (FIFRA SAP) to consider and review two topics. The first topic is to update the FIFRA SAP VerDate May< 23> 2002 17: 37 May 30, 2002 Jkt 197001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 31MYN1. SGM pfrm15 PsN: 31MYN1

epa

2024-06-07T20:31:41.128042

regulations

EPA-HQ-OEI-2002-0003-0001

Notice

TRI ICR Notice for Form R

44197 Federal Register / Vol. 67, No. 126 / Monday, July 1, 2002 / Notices unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. The Agency today begins an effort to examine the notification forms and consider options for reducing their burden and increasing the usefulness of the information these forms collect. The Agency would appreciate any information on the users of this information, how they use this information, how the information could be improved, and how the burden for these forms can be reduced. Therefore, the EPA would like to solicit comments to: ( i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; ( ii) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; ( iii) Enhance the quality, utility, and clarity of the information to be collected; and ( iv) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e. g., permitting electronic submission of responses. Burden Statement: The estimated average burden for renewing the existing notification ICR is 4.25 hours per respondent for initial notifications and 1.84 hours per respondent for subsequent notifications. This estimates for the notification ICR includes all aspects of the information collection including time for reviewing instructions, searching existing data sources, gathering data, and completing and reviewing the form. EPA estimates that the number of respondents per year for notifications is 31,125 ( 16,174 initial notifications and 14,951 subsequent notifications). For this ICR, collection occurs one time per respondent, unless regulations are revised and promulgated. Timing of the submission of the notification is variable depending on the status of the respondent and the timing of the promulgation of the regulations. The estimated total annual burden on respondents for initial and subsequent notifications is 96,250 hours. These estimates of total annual burden reflect a decrease in burden of 3.9% for all notifications when compared with the previously approved ICR ( 1999). Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Dated: June 7, 2002. Elizabeth A. Cotsworth, Director, Office of Solid Waste. [ FR Doc. 02 16464 Filed 6 28 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OEI 10016; FRL 6723 9] Toxic Chemical Release Reporting; Alternate Threshold for Low Annual Reportable Amounts; Request for Comment on Renewal Information Collection AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this notice announces that EPA is planning to submit the following continuing Information Collection Request ( ICR) to the Office of Management and Budget ( OMB) pursuant to the procedures described in 5 CFR 1320.12: Alternate Threshold for Low Annual Reportable Amounts, Toxic Chemical Release Reporting ( EPA ICR No. 1704.06, OMB No. 2070 0143). This ICR covers the reporting and recordkeeping requirements associated with reporting under the alternate threshold for reporting to the Toxics Release Inventory ( TRI), which appear in 40 CFR part 372. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR Chapter 15. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection as described below. DATES: Comments, identified by the docket control number OEI 10016, must be submitted on or before August 30, 2002. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit III. of the SUPPLEMENTARY INFORMATION section of this notice. FOR FURTHER INFORMATION: For general information, contact The Emergency Planning and Community Right­ to­ Know Hotline at ( 800) 424 9346 or ( 703) 412 9810, TDD ( 800) 553 7672, http:// www. epa. gov/ epaoswer/ hotline/. For technical information about this ICR renewal, contact: Judith Kendall, Toxics Release Inventory Program Division, OEI ( 2844T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460, Telephone: 202 566 0750; Fax: 202 566 0727; email: kendall. judith@ epa. gov. SUPPLEMENTARY INFORMATION: I. Does This Notice Apply to Me? A. Affected Entities: Entities that will be affected by this action are those facilities that manufacture, process, or otherwise use certain toxic chemicals listed on the Toxics Release Inventory ( TRI) and which are required under section 313 of the Emergency Planning and Community Right­ to­ Know Act of 1986 ( EPCRA), to report annually to EPA their environmental releases of such chemicals. Currently, those industries with the following SIC code designations ( that meet all other threshold criteria for TRI reporting) must report toxic chemical releases and other waste management activities: 20 39, manufacturing sector 10, metal mining ( except for SIC codes 1011, 1081, and 1094) 12, coal mining ( except for SIC code 1241 and extraction activities) 4911, 4931 and 4939, electrical utilities that combust coal and/ or oil for the purpose of generating power for distribution in commerce. 4953, RCRA Subtitle C hazardous waste treatment and disposal facilities 5169, chemicals and allied products wholesale distributors 5171, petroleum bulk plants and terminals 7389, solvent recovery services, and federal facilities in any SIC code To determine whether you or your business is affected by this action, you should carefully examine the VerDate May< 23> 2002 23: 22 Jun 28, 2002 Jkt 197001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 01JYN1. SGM pfrm17 PsN: 01JYN1 44198 Federal Register / Vol. 67, No. 126 / Monday, July 1, 2002 / Notices applicability provisions at 40 CFR part 372 and section 4( a) of the Supporting Statement of the information collection. If you have any questions regarding the applicability of this action to a particular entity, consult the person( s) listed in the FOR FURTHER INFORMATION CONTACT section. II. How Can I Get Additional Information or Copies of This Document and Other Support Documents: A. Electronic Availability Internet Electronic copies of the ICR are available from the EPA Home Page at the Federal Register Environmental Documents entry for this document under `` Laws and Regulations'' ( http:// www. epa. gov/ fedrgstr/). An electronic copy of the collection instrument referenced in this ICR and instructions for its completion are available at http:// www. epa. gov/ triinter/# forms. In Person The Agency has established an official record for this action under docket control number OEI 10016. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, North East Mall Rm. B 607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number of the Center is ( 202) 260 7099. III. How Can I Respond to This Notice? A. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. Be sure to identify the appropriate docket control number ( i. e., `` OEI 10016'') in your correspondence. 1. By mail. All comments should be sent in triplicate to: Document Control Office ( 7407), Office of Pollution Prevention and Toxics ( OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Ariel Rios Building, Washington, DC 20460. 2. In person or by courier. Comments may be delivered in person or by courier to: OPPT Document Control Office ( DCO) in East Tower Rm. G 099, Waterside Mall, 401 M St., SW., Washington, DC. The DCO is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is ( 202) 260 7093. 3. Electronically. Submit your comments electronically by e­ mail to: `` oppt. ncic@ epa. gov.'' Please note that you should not submit any information electronically that you consider to be CBI. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on standard computer disks in WordPerfect 6.1/ 8.0 or ASCII file format. All comments and data in electronic form must be identified by the docket control number OEI 10016. Electronic comments on this document may also be filed online at many Federal Depository Libraries. B. How Should I Handle CBI Information That I Want To Submit to the Agency? All comments which contain information claimed as CBI must be clearly marked as such. Three sanitized copies of any comments containing information claimed as CBI must also be submitted and will be placed in the public record for this document. Persons submitting information on any portion of which they believe is entitled to treatment as CBI by EPA must assert a business confidentiality claim in accordance with 40 CFR 2.203( b) for each such portion. This claim must be made at the time that the information is submitted to EPA. If a submitter does not assert a confidentiality claim at the time of submission, EPA will consider this as a waiver of any confidentiality claim and the information may be made available to the public by EPA without further notice to the submitter. C. What Information Is EPA Particularly Interested In? Pursuant to section 3506( c)( 2)( a) of the PRA, EPA specifically solicits comments and information to enable it to: ( i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; ( ii) Evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; ( iii) Enhance the quality, utility, and clarity of the information to be collected; and ( iv) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e. g., permitting electronic submission of responses. In addition, EPA is requesting comment on a minor change to Certification Form A in this ICR. Facilities will be required to supply an e­ mail address on the Form A that will help to facilitate better lines of communication between EPA and facilities reporting to TRI. IV. To What Information Collection Activity or ICR Does This Notice Apply? EPA is seeking comments on the following ICR, as well as the Agency's intention to renew the corresponding OMB approval, which is currently scheduled to expire on January 31, 2003. Title: Alternate Threshold for Low Annual Reportable Amounts. ICR numbers: EPA ICR No. 1704.06, OMB No. 2070 0143. Abstract: EPCRA section 313 requires certain facilities manufacturing, processing, or otherwise using certain toxic chemicals in excess of specified threshold quantities to report their environmental releases of such chemicals annually. Each such facility must file a separate report for each such chemical. In accordance with the authority in EPCRA, EPA has established an alternate threshold for those facilities with low amounts of a listed toxic chemical in wastes. A facility that otherwise meets the current reporting thresholds, but estimates that the total amount of the chemical in waste does not exceed 500 pounds per year, and that the chemical was manufactured, processed, or otherwise used in an amount not exceeding 1 million pounds during the reporting year, can take advantage of reporting under the alternate threshold option for that chemical for that reporting year. Each qualifying facility that chooses to apply the revised threshold must file the Form A Certification Statement ( EPA Form 9350 2) in lieu of a complete TRI reporting Form R ( EPA Form 9350 1). In submitting the Form A certification statement, the facility certifies that the sum of the amount of VerDate May< 23> 2002 23: 22 Jun 28, 2002 Jkt 197001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 01JYN1. SGM pfrm17 PsN: 01JYN1 44199 Federal Register / Vol. 67, No. 126 / Monday, July 1, 2002 / Notices the EPCRA section 313 chemical in wastes did not exceed 500 pounds for the reporting year, and that the chemical was manufactured, processed, or otherwise used in an amount not exceeding 1 million pounds during the reporting year. Use of the Form A certification represents a substantial savings to respondents, both in burden hours and in labor costs. The Form A certification statement provides communities with information that the chemical is being manufactured, processed or otherwise used at facilities. Additionally, the Form A certification provides compliance monitoring and enforcement programs and other interested parties with a means to track chemical management activities and verify overall compliance with the rule. Responses to this collection of information are mandatory ( see 40 CFR part 372) and facilities subject to reporting must submit either a Form A certification or a Form R. V. What Are EPA's Burden and Cost Estimates for This ICR? Under the PRA, `` burden'' means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a federal agency. For this collection, it includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. The annual public burden for this collection of information, which is approved under OMB Control No. 2070 0143, is estimated to average 13.7 hours for facilities submitting a Form A certification statement for a single listed chemical. By comparison, the average time required for calculations, form completion and record keeping/ mailing for Form R is estimated to average 19.5 hours per form. Thus, for a facility filing a Form A certification for a single chemical, the alternate threshold yields an average savings of 5.8 hours. The ICR supporting statement provides a detailed explanation of the burden estimates that are summarized in this notice. The following is a summary of the estimates taken from the ICR supporting statement: Estimated No. of Respondents: 5,451 respondents. Frequency of Responses: Annual. Estimated Total Annual Burden Hours: 145,534 burden hours. Estimated Total Annual Burden Costs: $ 6.35 million. VI. Are There Changes in the Estimates From the Last Approval? The estimated burden described above differs from what is currently in OMB's inventory for alternate threshold reporting: 14,793 responses ( chemicals) and 644,761 burden hours. The burden estimated in this supporting statement differs from OMB's inventory as a result of adjustments to estimates of the number of responses ( from 14,793 responses ( chemicals) to 5,121 responses ( Form As)), changes to unit reporting burden estimates ( from 30.2 to 9.2 burden hours per chemical certified on a Form A), and an adjustment for use of TRI ME, EPA's intelligent report software ( an additional burden reduction of 3.1 hours per chemical certified on a Form A) for those forms completed using TRI ME. These changes are described in greater detail in the supporting statement for this ICR, available in the public version of the official record. VII. What Is the Next Step in the Process for This ICR? EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another Federal Register notice pursuant to 5 CFR 1320.5( a)( 1)( iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the person( s) listed in the FOR FURTHER INFORMATION CONTACT section. List of Subjects in 40 CFR Part 372 Environmental protection, Information collection requests, Reporting and record keeping requirements. Dated: June 24, 2002. Ramona Trovato, Acting Assistant Administrator and Chief Information Officer, Office of Environmental Information. [ FR Doc. 02 16479 Filed 6 28 02; 8: 45 am] BILLING CODE 6560 50 U ENVIRONMENTAL PROTECTION AGENCY [ FRL 7239 6] National Advisory Council for Environmental Policy and Technology AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice of meeting. SUMMARY: Under the Federal Advisory Committee Act, P. L. 92463, EPA gives notice of a meeting of the National Advisory Council for Environmental Policy and Technology ( NACEPT). NACEPT provides advice and recommendations to the Administrator of EPA on a broad range of environmental policy and management issues. NACEPT consists of a representative cross­ section of EPA's partners and principle constituents who provide advice and recommendations on policy issues and serve as a sounding board for new strategies that the Agency is developing. NACEPT will discuss a number of issues, including emerging trends facing the agency, environmental technology, and other program office initiatives. In addition, NACEPT will report on the work and status of subcommittees and workgroups. DATES: NACEPT will hold a two­ day public meeting on Thursday, July 18, 2002, from 8: 30 a. m to 5 p. m., and Friday, July 19, 2002, from 8: 30 a. m. to 4 p. m. ADDRESSES: The meeting will be held at the Hotel Washington at 515 15th Street NW., Washington, DC. The meeting is open to the public, with limited seating on a first­ come, first­ served basis. FOR FURTHER INFORMATION CONTACT: Mark Joyce, Designated Federal Officer, U. S. EPA, Office of Cooperative Environmental Management, at ( 202) 564 9802. Meeting Access: Individuals requiring special accommodation at this meeting, including wheelchair access, should contact Mark Joyce at least five business days prior to the meeting so that appropriate arrangements can be made. Dated: June 21, 2002. Mark Joyce, Designated Federal Officer. [ FR Doc. 02 16462 Filed 6 28 02; 8: 45 am] BILLING CODE 6560 50 P VerDate May< 23> 2002 23: 22 Jun 28, 2002 Jkt 197001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 01JYN1. SGM pfrm17 PsN: 01JYN1

epa

2024-06-07T20:31:41.133081

regulations

EPA-HQ-OEI-2002-0003-0002

Notice

Agency Information Collection Activities; Submission of EPA ICR No. 1363.12 (OMB No. 2070-0093) to OMB for Review and Approval; Comment Request; Toxic Chemical Release Reporting

72168 Federal Register / Vol. 67, No. 233 / Wednesday, December 4, 2002 / Notices and approval. Any comments related to the renewal of this ICR should be submitted within 30 days of this notice, as described above. Dated: November 22, 2002. Oscar Morales, Director, Collection Strategies Division, Office of Environmental Information. [ FR Doc. 02 30761 Filed 12 3 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OEI 2002 0003; FRL 7417 3] Agency Information Collection Activities; Submission of EPA ICR No. 1363.12 ( OMB No. 2070 0093) to OMB for Review and Approval; Comment Request; Toxic Chemical Release Reporting AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act ( PRA) ( 44 U. S. C. 3501 et seq.), this notice announces that the Information Collection Request ( ICR) ( EPA ICR No. 1363.12; OMB Control No. 2070 0093) for the Toxics Release Inventory ( TRI) Form R has been forwarded to the Office of Management and Budget ( OMB) for review and approval pursuant to the OMB procedures in 5 CFR 1320.12. The ICR, which is summarized below, describes the nature of the information collection and its estimated burden and cost, and it includes the actual data collection instrument where appropriate. The Agency is requesting that OMB renew for three years the existing approval for this ICR, which is scheduled to expire on January 31, 2003. A Federal Register notice announcing the Agency's intent to seek the renewal of this ICR and the 60­ day public comment opportunity, requesting comments on the request and the contents of the ICR, was issued on July 1, 2002 ( 67 FR 44213). A Federal Register correction notice, correcting the address for submission of comments in person, was issued on July 15, 2002 ( 67 FR 46502). EPA received a number of comments on this ICR during the comment period, and EPA has developed responses to those comments. The comments and EPA's responses are included in an attachment to the ICR Supporting Statement that is being submitted to OMB with this ICR renewal request, and will be made available in the docket for OEI 2002 0003 and on the EPA TRI Web site at http:// www. epa. gov/ tri. DATES: Additional comments may be submitted on or before January 3, 2003. FOR FURTHER INFORMATION CONTACT: Judith Kendall, TRI Program Division, Office of Environmental Information, Mailcode 2844, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 202) 566 0750; email address: kendall. judith@ epa. gov; fax number: ( 202) 566 0741. ADDRESSES: Follow the detailed instructions in SUPPLEMENTARY INFORMATION. SUPPLEMENTARY INFORMATION: Review Requested: This is a request to renew a currently approved information collection pursuant to 5 CFR 1320.12. ICR Numbers: EPA ICR 1363.12; OMB Control No. 2070 0093. Current Expiration Date: Current OMB approval expires on January 31, 2003. EPA has established a public docket for this ICR under Docket ID No. OEI 2002 0003, which is available for public viewing at the OEI Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the OEI Docket is ( 202) 566 1752. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: ( 1) Submit your comments to EPA online using EDOCKET ( our preferred method), by e­ mail to oei. docket@ epa. gov or by mail to: EPA Docket Center, Environmental Protection Agency, Mailcode: 2844, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and ( 2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. EPA's policy is those public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to http:// www. epa. gov/ edocket. Title: Toxic Chemical Release Reporting, Recordkeeping, Supplier Notification and Petitions under Section 313 of the Emergency Planning and Community Right­ to­ Know Act ( EPCRA). Background: EPCRA section 313 requires owners and operators of certain facilities that manufacture, process, or otherwise use any of the more than 650 listed toxic chemicals and chemical categories in excess of applicable threshold quantities to report annually to the Environmental Protection Agency and to the states in which such facilities are located on their environmental releases and other waste management quantities of such chemicals. In addition, section 6607 of the Pollution Prevention Act ( PPA) requires that facilities provide information on the quantities of the toxic chemicals in waste streams and the efforts made to reduce or eliminate those quantities. Annual reporting of toxic chemical releases and other waste management information under EPCRA section 313 provides citizens with a more complete picture of the total disposition of chemicals in their communities and helps focus industries' attention on pollution prevention and source reduction opportunities. EPA believes that the public has a right to know about the disposition of chemicals within communities and the management of such chemicals by facilities in industries subject to EPCRA section 313 reporting. This reporting has been successful in providing communities with important information regarding VerDate 0ct< 31> 2002 19: 04 Dec 03, 2002 Jkt 200001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 04DEN1. SGM 04DEN1 72169 Federal Register / Vol. 67, No. 233 / Wednesday, December 4, 2002 / Notices the disposition of toxic chemicals and other waste management information of toxic chemicals from manufacturing facilities in their areas. EPA collects, processes, and makes available to the public all of the information collected. The information gathered under these authorities is stored in a database maintained at EPA and is available through the Internet. This information, commonly known as the Toxics Release Inventory ( TRI), is used extensively by both EPA and the public sector. Program offices within EPA use TRI data, along with other sources of data, to establish priorities, evaluate potential exposure scenarios, and undertake enforcement activities. Environmental and public interest groups use the data in studies and reports, making the public more aware of releases of chemicals in their communities. Comprehensive publicly­ available data about releases, transfers, and other waste management activities of toxic chemicals at the community level are generally not available, other than under the reporting requirements of EPCRA section 313. Permit data are often difficult to obtain, are not cross­ media and present only a limited perspective on a facility's overall performance. With TRI data, and the real gains in understanding it has produced, communities and governments know what toxic chemicals are released, transferred, or otherwise managed as a waste in their area by industrial facilities. In addition, industries have an additional tool for evaluating efficiency and progress on their pollution prevention goals. Responses to the collection of information are mandatory ( see 40 CFR part 372). Respondents may claim all or part of a notice confidential. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and 40 CFR part 2. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR Chapter 15. Burden Statement: Under the PRA, `` burden'' means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a federal agency. For this collection, it includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. The ICR supporting statement provides a detailed explanation of this estimate, which is only briefly summarized in this notice. The annual public burden for this collection of information is estimated to average 19.5 hours per response. The following is a summary of the estimates taken from the ICR: Respondents/ affected entities: Entities potentially affected by this action are owners or operators of certain facilities that manufacture, process, or otherwise use certain specified toxic chemicals and chemical categories and are required to report annually on the environmental releases and transfers of waste management activities for such chemicals. Estimated total number of potential responses: 88,117. Frequency of response: Annual. Estimated total annual burden hours: 2,477,952. Estimated total annual burden costs: $ 107.4 million. Changes in Burden Estimates: As a result of OMB's March 7, 2002 approval of an information correction worksheet, OMB's inventory reflects 145,972 responses and 9,612,104 hours for this information collection. This ICR supporting statement is for 88,117 responses and 2,477,952 hours. The reduction in burden of approximately 7.1 million hours is the result of five adjustments. The first adjustment is to the number of responses. The estimate of 145,972 responses in the existing OMB approval incorporated predicted reporting increases from economic analyses for several final rules. In all cases, these predictions have overestimated actual reporting levels, resulting in a cumulative overestimate of the number of responses. For example, the 1997 program change for industry expansion estimated 39,033 responses would be submitted, but only 12,567 responses were actually submitted. Likewise, the 1999 program change for PBT chemical thresholds estimated 19,990 responses would be submitted, but only about 6,600 responses per year were actually submitted. The number of responses in this ICR supporting statement have been adjusted to accurately reflect actual subsequent year reporting levels, with the exception of predicted additional responses from the rule lowering reporting thresholds for lead and lead compounds. The prediction of 9,813 additional reports for lead and lead compounds may prove to be an overestimate, as with EPA predictions for past rules. Adjusting the number of responses to accurately reflect actual subsequent year reporting levels ( where available) results in a decrease of 59,617 responses from subsequent year filers and approximately 3.1 million burden hours ( at 52.1 hours per response). The second adjustment is to the unit burden hours. EPA has adjusted the estimate of unit burden hours for Form R completion in subsequent years from 47.1 hours to 14.5 hours based on responses from actual TRI reporting facilities. The adjustment to unit burden hours does not affect the number of responses, but reduces total burden by approximately 2.8 million burden hours ( using the number of subsequent year responses for this ICR). The third adjustment relates to firstyear reporting burden. In previous ICRs, the renewal period has coincided with programmatic changes in one or more years. Previous ICRs have been based on annualized estimates of burden ( including time for rule familiarization and higher first year reporting burdens for facilities affected by programmatic changes). Since there are no final rules pending at this time, this ICR renewal does not require annualized burden estimates that account for first­ year reporting burden by facilities affected by programmatic changes. However, the ICR does account for a baseline level of first­ time filers that are new to TRI reporting each year. This accounts for a reduction of about 900,000 burden hours. The fourth adjustment relates to the adoption of TRI ME, an automated reporting software package. EPA has reduced the burden estimates related to Form R Completion and Recordkeeping/ Submission by 25 percent for the reports filed using TRI ME. On an annualized basis, an estimated 60 percent of reports are expected to be filed using TRI ME over the three years of the ICR. This results in a reduction of approximately 270,000 hours. The fifth adjustment relates to the number of petitions. In previous ICRs, EPA has estimated 11 petitions per year. Since the actual number has been 1 to 2 per year, this ICR renewal has reduced the expected number of petitions to 5. This adjustment has a very minor impact on total burden. VerDate 0ct< 31> 2002 19: 04 Dec 03, 2002 Jkt 200001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 04DEN1. SGM 04DEN1 72170 Federal Register / Vol. 67, No. 233 / Wednesday, December 4, 2002 / Notices The sum of these adjustments is a decrease of 57,855 responses and 7,134,152 burden hours from the current approved total. According to the procedures prescribed in 5 CFR 1320.12, EPA has submitted this ICR to OMB for review and approval. Any comments related to the renewal of this ICR should be submitted within 30 days of this notice, as described above. Dated: November 22, 2002. Oscar Morales, Director, Collection Strategies Division, Office of Environmental Information. [ FR Doc. 02 30762 Filed 12 3 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0250; FRL 7274 7] Fenarimol; Availability of the Risk Assessments on FQPA Tolerance Reassessment Progress and Tolerance Reassessment Decision ( TRED) AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces the availability of EPA's tolerance reassessment decision and related documents for fenarimol including the Fenarimol Overview, Fenarimol Summary, Fenarimol Decision Document ( TRED), and supporting risk assessment documents. EPA has reassessed the 42 tolerances, or legal limits, for residues of fenarimol in or on raw agricultural commodities. These tolerances are now considered safe under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act ( FQPA) of 1996. DATES: Comments on the tolerance reassessment decision or on the human health effects risk assessment for fenarimol, identified by docket ID number OPP 2002 0250, must be received by EPA on or before January 3, 2003. In the absence of substantive comments, the tolerance reassessment decision will be considered final. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP 2002 0250 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: Tom Myers, Special Review and Reregistration Division ( 7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 308 8589; email address: myers. tom@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general, but will be of interest to a wide range of stakeholders, including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the use of pesticides. The Agency has not attempted to describe all the persons or entities who may be interested in or affected by this action. If you have questions in this regard, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations,'' `` Regulations and Proposed Rules,'' and then look up the entry for this document under the `` Federal Register Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. You can obtain copies of the TRED and related documents discussed in this notice on EPA's website at http:// www. epa. gov/ pesticides/ reregistration/ status. htm. Information on pesticide reregistration and tolerance reassessment, including the purpose and status of Agency programs to complete Reregistration Eligibility Decisions ( REDs), Interim REDs, and tolerance reassessment decisions ( TREDs), is available at http:// www. epa. gov/ pesticides/ reregistration. General information is available on the Office of Pesticide Programs' home page, http:// www. epa. gov/ pesticides/. 2. In person. The Agency has established an official record for this action under docket ID numbers OPP 2002 0250. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805. C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP 2002 0250 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805. 3. Electronically. You may submit your comments electronically by e­ mail to: opp­ docket@ epa. gov, or you can submit a computer disk as described in this unit. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in WordPerfect 6.1/ 8.0/ 9.0 or ASCII file format. All comments in electronic form must be identified by docket ID number OPP 2002 0250. Electronic comments may also be filed online at many Federal Depository Libraries. D. How Should I Handle CBI that I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that VerDate 0ct< 31> 2002 19: 04 Dec 03, 2002 Jkt 200001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 04DEN1. SGM 04DEN1

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regulations

EPA-HQ-OEI-2002-0006-0001

Notice

Toxic Chemical Release Reporting; Community Right-To-Know; Notice of On-Line Dialogue

63656 Federal Register / Vol. 67, No. 199 / Tuesday, October 15, 2002 / Notices 385.2007, in which case the permit shall remain in effect through the first business day following that day. New applications involving this project site, to the extent provided for under 18 CFR part 4, may be filed on the next business day. Linwood A. Watson, Jr., Deputy Secretary. [FR Doc. 02– 26084 Filed 10– 11– 02; 8: 45 am] BILLING CODE 6717– 01– P ENVIRONMENTAL PROTECTION AGENCY [OEI– 2002– 0006; FRL– 6724– 6] Toxic Chemical Release Reporting; Community Right­ To­ Know; Notice of On­ Line Dialogue AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of Availability. SUMMARY: EPA will hold an on­ line public dialogue for 60­ days from October 16, 2002 to December 17, 2002 as part of a national Stakeholder Dialogue on the Toxics Release Inventory (TRI) Program that the Environmental Protection Agency (EPA) is launching. EPA is seeking suggestions and ideas on the Agency's methods for reporting, collecting, processing, and releasing the TRI data. Instructions for participating in the on­ line dialogue are posted at EPA's TRI Web site, see http:/ /www. epa. gov/ tri/ programs/ stakeholders/ outreach. htm. EPA is announcing the availability of three issue papers which are intended to provide background to help focus the on­ line dialogue. DATES: The Stakeholder Dialogue online comment process will be held from October 16, 2002 to December 17, 2002. ADDRESSES: The On­ line Dialogue will be accessible via the Internet at http:// www. epa. gov/ tri/ programs/ stakeholders/ outreach. htm. Please follow the instructions provided in Section I of the SUPPLEMENTARY INFORMATION section of this notice. FOR FURTHER INFORMATION CONTACT: For information on this stakeholder process, contact: Annette Marion, Environmental Protection Agency, Office of Environmental Information, Office of Information Analysis and Access, Toxics Release Inventory Program Division: telephone: (202) 566– 0731; Fax number: (202) 566– 0715; e­ mail: marion. annette@ epa. gov. For general information on the Toxics Release Inventory contact the Emergency Planning and Community Right­ to Know Hotline at (800) 424– 9346, or (703) 412– 9810, TDD (800) 553– 7672, http:// www. epa. gov/ epaoswer/ hotline. SUPPLEMENTARY INFORMATION: I. General Information A. Does This Notice Apply to Me? You may be interested in this notice if you use data collected under the Emergency Planning and Community Right­ to­ know Act (EPCRA) section 313, or if you manufacture, process, or otherwise use any of the EPCRA section 313 chemicals and you are required to report annually to EPA their environmental releases and other waste management quantities. Potentially affected entities may include, but are not limited to: Category Examples of potentially interested entities Public ............ Environmental groups, community groups, researchers Industry ......... SIC major group codes Except 1011, 1081, and 1094), 12 (except 1231), or 20 through 39; industry codes 4911 (limited to facilities that combusts coal and/ or oil for the purpose of generating power for distribution in commerce); or 4939 (limited to facilities that combusts coal and/ or oil for the purpose of generating power for distribution in commerce); or 4953 (limited to facilities regulated under the Resource Conservation and Recovery Act, subtitle C, 42 U. S. C. section 6921 et seq.), or 5169, or 5171, or 7389 (limited to facilities primarily engaged in solvent recovery services on a contract or fee basis). Federal Government Federal facilities in any SIC code. This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section. B. How Can I Get Copies of Information Associated With This Stakeholder Dialogue Process? 1. Electronic Access. Electronic copies of the issue papers are available from EPA's TRI Web site at http:// www. epa. gov/ tri/ programs/ stakeholders/ outreach. htm. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket, EPA Dockets (http:// www. epa. gov/ edocket/). To view the contents of the docket, go to the EPA Dockets web site. Once in the system, select `` search, '' then key in the appropriate docket identification number, OEI– 2002– 0006. 2. Docket. EPA has established an official public docket for this action under Docket ID No. OEI– 2002– 0006. The official public docket consists of the documents specifically referenced in this action and other information related to this action. The official public dockets are the collection of materials available for public viewing at the EPA Docket Center Public Reading Room located in the basement of EPA West, 1301 Constitution Avenue, NW., Washington, DC 20460. This Docket Facility is open from 8: 30 am to 4: 30 pm, Monday through Friday, excluding legal holidays. The Docket telephone number is (202)– 566– 1752. C. How Do I Participate in the On­ line Dialogue? You may submit your ideas and suggestions electronically through the TRI Stakeholder Outreach Web site at: http:// www. epa. gov/ tri/ programs/ stakeholders/ outreach. htm during the time period specified in this notice. D. How Should I Handle Confidential Business Information (CBI) That I Want To Submit to the Agency? Do not submit any information that you consider to be confidential business information (CBI) under this notice. II. Background EPA is undertaking a stakeholder dialogue for the Toxics Release Inventory (TRI) program. While the TRI program has been very successful, EPA is continuing to seek ways to improve the program. Given the community focus of the TRI program and the broad and varied uses of the TRI data, it is important that EPA receive input from all stakeholders— the states, the reporting community and other businesses, community and environmental groups, researchers, and the public. The stakeholder dialogue process will have two phases. Phase 1 will focus on the reporting, collecting, processing, and annual release of the TRI data. Specifically, EPA is seeking comment on ways to: (1) Improve the compliance VerDate 0ct< 02> 2002 20: 35 Oct 11, 2002 Jkt 200001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 15OCN1. SGM 15OCN1 63657 Federal Register / Vol. 67, No. 199 / Tuesday, October 15, 2002 / Notices assistance provided by the TRI program, both at Headquarters and in the Regions, to aid the reporting community; (2) streamline the collection and processing of the more than 90,000 TRI forms that EPA receives annually; and (3) improve the materials, including the context, documents and tools, that EPA develops for its annual public release of the TRI data to support their use and analysis of the data. The on­ line dialogue will be the first opportunity for stakeholder input in Phase 1. Once the dialogue has been analyzed, additional opportunities may be extended in the form of public meetings, more formal comment periods, or other methods which will be described in future notices. Phase 2 of the stakeholder dialogue will focus on future directions for the program, including what data are collected in the TRI, how these data are characterized, and whether additional data should be collected. One key element will be clarifying the data elements on recycling and other waste management activities required by the Pollution Prevention Act. A future Federal Register notice will announce Phase 2. III. Availability of Documents EPA is making available three papers which describe aspects of the TRI Program and raise issues for stakeholder discussion. The scope of each paper corresponds to a phase of the annual TRI reporting cycle. TRI data for a calendar year must be reported to EPA by July 1st after the end of that calendar year. Therefore, reporting years are the same as calendar years. The `` reporting cycle'' begins with EPA's compliance assistance activities, including the development of reporting forms and instructions that are generally mailed to facilities in March each year. Once EPA receives the forms, it enters the data from the forms (over 91,000 in 2000) in the TRI database. After entry into the database, EPA runs a series of data quality checks on both the facility identification information and on the chemical­ specific data. After the data entry and data quality steps are completed, the TRI database is `` frozen'' for analysis and development of data products for release to the public. Generally, EPA announces the annual release of the TRI data by holding a press event or issuing a press release, and simultaneously notifying a wide range of stakeholders. The first background paper for this stakeholder dialogue is entitled TRI Data Collection, Processing and Management, and addresses the TRI data process beginning with submission of the forms and ending at the data `` freeze. '' The second paper, TRI Data Release Issue Paper discusses TRI data products, the process for analyzing and releasing the TRI data, uses of the data, and issues and considerations associated with these aspects of the TRI program. The third paper is TRI Compliance Assistance Activities. TRI compliance assistance activities are carried out throughout the year with certain of the activities being closely aligned with the reporting cycle. Dated: October 4, 2002. Elaine G. Stanley, Director, Office of Information Analysis and Access. [FR Doc. 02– 26175 Filed 10– 11– 02; 8: 45 am] BILLING CODE 6561– 07– P ENVIRONMENTAL PROTECTION AGENCY [OEI– 2002– 0008; FRL6724– 5] Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency AGENCY: Environmental Protection Agency, EPA. ACTION: Notice of availability. SUMMARY: The U. S. Environmental Protection Agency (EPA) has developed final Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency (herein after referred to as Information Quality Guidelines), in response to final Office of Management and Budget (OMB) information quality guidelines directing all federal agencies to develop and implement their own guidelines by October 1, 2002 (67 FR 8451, February 22, 2002). The EPA Information Quality Guidelines build upon on­ going efforts to improve the quality of the data and analyses that support Agency policy and regulatory decisions and programs. EPA is announcing the availability of the Agency's final Information Quality Guidelines at the EPA Web site, www. epa. gov/ oei/ qualityguidelines. As described in the new Information Quality Guidelines, EPA is also introducing a Request for Correction process to allow affected persons to seek and obtain correction of information that EPA disseminates that they believe does not meet the EPA Information Quality Guidelines or the OMB information quality guidelines (67 FR 8451, February 22, 2002). Please read the Information Quality Guidelines to learn more about this new Request for Correction process including where and how to submit a request for correction. DATES: The EPA final Information Quality Guidelines were made available on October 2, 2002. ADDRESSES: The Information Quality Guidelines can be found at the EPA Web site at http:// www. epa. gov/ oei/ qualityguidelines. To obtain a written copy of the Information Quality Guidelines, you may contact: Ms. Evangeline Tsibris Cummings, U. S. Environmental Protection Agency, Office of Environmental Information, Mail Code 2842T, 1200 Pennsylvania Avenue NW., Washington, DC 20460; Telephone: 202– 566– 0621; or e­ mail: cummings. evangeline@ epa. gov. SUPPLEMENTARY INFORMATION: In accordance with the OMB information quality guidelines, EPA published a notice in the Federal Register on April 30, 2002 (67 FR 21234) announcing the availability of EPA's draft Information Quality Guidelines and soliciting public comment by May 31, 2002. EPA extended the comment period to June 21, 2002 (67 FR 42254). After considering the extensive public comment, EPA revised its Information Quality Guidelines and submitted the revised draft to OMB in accordance with OMB's guidelines so OMB could review the draft Information Quality Guidelines for consistency with OMB's information quality guidelines. OMB completed its review and approved of the final EPA Information Quality Guidelines. EPA's general discussion of and responses to the public comments appears in Appendix A of EPA's Information Quality Guidelines. FOR FURTHER INFORMATION CONTACT: Ms. Evangeline Tsibris Cummings, Environmental Protection Agency, Office of Environmental Information, Mail Code 2842T, 1200 Pennsylvania Avenue NW., Washington, DC 20460. Telephone: 202– 566– 0621; e­ mail: cummings. evangeline@ epa. gov. Elaine Stanley, Director, Office of Information Analysis and Access, Office of Environmental Information, EPA. [FR Doc. 02– 26176 Filed 10– 11– 02; 8: 45 am] BILLING CODE 6560– 50– P VerDate 0ct< 02> 2002 20: 35 Oct 11, 2002 Jkt 200001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 15OCN1. SGM 15OCN1

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EPA-HQ-OEI-2002-0006-0003

Supporting & Related Material

­ 1­ TRI DATA RELEASE PAPER for Stakeholder Outreach I. BACKGROUND This is one of three papers which describe aspects of the Toxics Release Inventory ( TRI) Program and raise issues for stakeholder input. The scope of each paper corresponds to a phase of the annual TRI reporting cycle. TRI data for a calendar year must be reported to EPA each year by July 1st after the end of the year. Therefore, reporting years are the same as calendar years. The " reporting cycle" begins with EPA's compliance assistance activities, including the development of its reporting forms and instructions package that is mailed to facilities in approximately March of each year. Once EPA receives the forms, it enters the data from the forms ( over 91,000 in 2000) in its TRI database. After entry into the database, EPA runs a number of data quality checks on both the facility identification information and on the chemical­ specific data. After the data entry and data quality steps are completed, the TRI database is " frozen" for analysis and development of data products for release to the public. Generally, EPA announces the annual release of the TRI data by holding a press event or issuing a press release, and simultaneously notifying a wide range of stakeholders. The background paper for this stakeholder process is entitled TRI Data Collection, Processing and Management, and addresses the TRI data process beginning with submission of the forms and ending at the data " freeze." This paper, TRI Data Release Issue Paper is the second of the three; it discusses TRI data products, the process for analyzing and releasing the TRI data, uses of the data, and issues and considerations associated with these aspects of the TRI program. The third paper is TRI Compliance Assistance Activities. TRI compliance assistance activities are carried out throughout the year with certain of the activities being closely aligned with the reporting cycle. As noted above, each year, once EPA finishes processing the TRI data it receives the previous July 1, the Agency " freezes" the data in order to prepare the data for the TRI public data release. Once the TRI data is " frozen," it takes the Agency approximately 3 months to conduct the analyses, prepare the data release reports, and prepare the data access tools to be ready to " release" the data to the public. Providing quality assurance of data and quality management of the public information and data tools is a key component at this time. EPA makes the TRI data available to the public in several different ways. First, the data are provided to the public on­ line through two EPA data access tools: TRI Explorer and the EPA Envirofacts on­ line data warehouse. Second, the Agency prepares a two­ volume Public Data Release ( PDR) report and an Executive Summary which are made available in both hard copy and on the TRI website. Additional background materials, including charts and graphs, state and national data files, ­ 2­ press materials, etc., are also made available on the TRI website. While some stakeholders have voiced concerns that EPA is not providing the data early enough, others have emphasized the need for the Agency to analyze the data and provide the type of context contained in the PDR reports at the same time EPA makes the TRI data publicly available each year. Undertaking these analyses and preparing the reports in a manner consistent with EPA quality systems affects the timing of the release of the data. The purpose of this issue paper is to describe the data release process and how the TRI data is used, in order to solicit stakeholder input on the process and the data products. The next section of the paper, TRI Data Products, describes the many reports and data access tools EPA makes available for the TRI data release each year. The following section, entitled TRI Data Release Process describes how the data products are prepared, including a schedule of the tasks involved. The last section discusses several important aspects of the data release process ( following the data freeze), such as timing of the release, the need for context for the data, the extent of data quality efforts, etc., as well as options for changing these aspects of the release. In each section we have included questions in italics to help focus the stakeholder comments. II. TRI DATA PRODUCTS Public Data Release Reports Beginning in 1988, EPA has prepared a Public Data Release Report, or set of reports, each year in order to summarize the TRI data. The last 5 years' data release reports are available at www. epa. gov/ tri/ tridata/ index. htm# pdr. The reports can also be obtained by calling the TRI Documents distribution line at ( 202) 564­ 9554. In the last several years the Agency has been preparing three reports for the TRI data release. One is the Public Data Release Report, which provides a variety of analyses of the data including industry analyses, trend analyses, analyses of the data by media, by state, and by chemical. It also includes a large chemical table which summarizes the releases for each chemical for the current year and select previous years, including the first year of reporting on the chemical. The first chapter of this report explains the TRI reporting requirements and how they have changed over time. It also describes each data element and explains the factors to consider when using the data. These reports are roughly 400 pages long, including appendices that are approximately 200 pages. They contain over 150 tables and figures. When the Agency is reporting on a set of chemicals or industries for the first time, the data release report will usually include more in­ depth analyses of those industry sectors or chemicals. For ­ 3­ instance, this year's Public Data Release report on the 2000 TRI data included an extensive section on persistent bioaccumulative toxic chemicals, for which reporting requirements were revised in 2000. The second major information product prepared each year is the " State Fact Sheets" report, which is a compilation of 4­ page fact sheets on the TRI data for each state as well as summary tables which present state rankings on a variety of measures including total releases, on­ site releases, off­ site releases, total waste managed, releases from manufacturing, and from non­ manufacturing industries. The individual state fact sheets include lists of top­ ranked facilities for each state. The third information product is an executive summary which is approximately 12 pages and provides an overview of the data, including summary tables, charts and graphs showing the distribution of releases and total wastes by industry, by media, and over time. It includes a short explanation of the TRI reporting requirements and the factors to be considered when using the data. In the past few years, in efforts to make the TRI data available as early as possible, information products have been made available on the internet at the time the data is released and the printed reports have been made available approximately 6 weeks later. Thus, the Agency is able to release the TRI data 6 weeks earlier. EPA would like comments on each of the data release reports, including how they meet users' data and information needs, and suggestions for changes. TRI Electronic Data Access Tools EPA has two main TRI electronic data access tools, the TRI Explorer ( www. epa. gov/ triexplorer/ chemical. htm) and Envirofacts ( www. epa. gov/ enviro). Both can be accessed through the TRI web site at www. epa. gov/ tri. TRI Explorer is a user­ friendly tool that enables the user to generate reports on chemical releases and other waste management activities by facilities, chemicals, geographic areas, or industry type at the county, state, or national level. Envirofacts is EPA's on­ line data " warehouse" which provides the public with direct access to EPA databases including TRI. Users can access basic facility information and chemical reports, which tabulate air emissions, surface water discharges, releases to land, underground injections, and transfers to off­ site locations. Envirofacts also allows for custom queries, allowing the user to focus on specific data elements of interest. In addition to these data access tools, EPA prepares TRI data files ( in ASCII) that more sophisticated users can take and analyze themselves using data management and analytical tools of their choice, e. g., spreadsheets or other data management tools. These TRI data files are made available on the TRI web site ( www. epa. gov/ tri/ tridata/ state_ data_ files. htm). They are available by state or on a ­ 4­ national basis. EPA is seeking users' comments on these data access tools, including comments on how they do or don't meet user needs. Please be as specific as possible about the data access tool( s) you are commenting on, and about any suggestions for improvements. There are two other tools for accessing TRI data which have been developed by other organizations. One is RTKNET ( www. rtk. net), developed by the organization OMB Watch. It provides access to a number of databases, including TRI, for communities to learn about their environment. The other is TOXNET, a National Library of Medicine tool to search the TRI data online ( www. toxnet. nlm. nih. gov). Before EPA had its own electronic data access tools, TOXNET provided the only electronic access to the TRI data. Other TRI Data Products When the TRI data is made available to the public each year, the Agency creates a Data Release web page ( www. epa. gov/ tri/ tridata/ tri00/ index. htm) that provides users with the TRI reports, access to TRI Explorer and Envirofacts, and a number of other information products that help summarize and provide context for the data. These include a set of press materials which contain summary charts, graphs, and tables, an overview of the TRI program which includes an explanation of the limitations of the data, Q's and A's, and other information that provides context to the TRI data. EPA would like comments on these additional data tools in terms of how well they meet users' needs. EPA is also seeking comments on the whole suite of tools made available for accessing and using the TRI data. Do these tools as a whole meet the wide range of user needs? Do users need more links to other data, including exposure, health, and environmental data, in order to effectively utilize the TRI data? Is more context information needed? Are there ways EPA can partner with other organizations to produce new tools? III. TRI DATA RELEASE PROCESS Development of all the data products that have been described here takes approximately 3 months, with many of the project tasks being done simultaneously. EPA has contractor support for preparing both the data release reports and the on­ line data access tools. The most time­ consuming part of the process of analyzing and releasing the data is the preparation of the two­ volume data release reports, which take the entire three months, including review time. Figure 1 ( attached) lays out the steps required to prepare the data release reports and the TRI Explorer data access tool. Many of the ­ 5­ steps are performed simultaneously because of the need to release the data as soon as possible. One of the first steps in the process is preparing an outline and list of tables and figures to be included in the data release reports. This is done prior to the data freeze. Following the data freeze, the first major task involved with preparing the data release reports is to develop the data tables for preparing the public data release reports and for checking the TRI Explorer. These are necessary to analyze the data and write up the results. These tables are submitted to EPA for review. Preparing a first draft of the entire Public Data Release report takes about 8 weeks from the time the data is frozen ( some of the text is prepared before all the tables are run). After review and comment by EPA the draft needs to be sent to the design subcontractor for layout. This step takes about 1 week. Finally approximately 2 weeks are needed for review and comment by the Agency. The State Fact Sheets and the ranking tables contained in the State Fact Sheets Report take roughly 2 weeks to prepare in draft form, and then a week is required for formatting and layout by the design subcontractor. Then they are submitted to EPA for review both by EPA and the states. EPA has the regional TRI coordinators distribute individual state fact sheets to the TRI coordinators in their region to review and make sure they are consistent with their databases. This review/ correction process takes approximately 2.5 weeks. Therefore, a total of about 5­ 6 weeks is necessary for preparation of the State Fact Sheets Report. The Executive Summary takes approximately 6 weeks to prepare, including approximately 2 weeks for analyzing the data and developing the tables and 2 weeks for the text. In addition, approximately 2 weeks is needed for review and design work on the report. Finally a week is needed for printing. Timeframes for the development of the additional data release materials are provided in Figure 1, i. e. roughly 1.5 weeks for the contractor to develop press materials, 4 weeks for EPA to create the national and state data files in ASCII, 6 weeks for EPA to develop and coordinate Agency review of a set of Qs and As on the data ( once the tables are prepared), and 5 weeks to prepare materials for notifying interested parties of the data release. Preparation of the TRI Explorer for the TRI public data release varies depending upon whether enhancements are being introduced at the time of the data release. If no new enhancements are being introduced, it should take approximately 2 months to prepare the TRI Explorer for the data release. If new enhancements are being introduced, additional time is needed for developing, testing, and correcting the tool, increasing the total time needed to about 2.5 ­ 3 months. IV. OPTIONS FOR RELEASING THE TRI DATA EARLIER ­ 6­ There are ways in which the Agency could reduce the amount of time it takes to make the data available after the data freeze. One way would be to simply make the data available through Envirofacts and TRI Explorer. This would take approximately 6­ 7 weeks from the data freeze. However, it would not allow the Agency time to analyze the data in order to answer questions that might be raised nor time to prepare contextual materials other than the standard documents that explain the data and its limitations. In addition, it would eliminate part of the data quality efforts that are carried out during this time period. Another option for reducing the amount of time it takes to release the data would be to prepare the Executive Summary, as is currently done, along with the release of the data on TRI Explorer and Envirofacts. This would take approximately 8­ 9 weeks from the data freeze and would allow a little time to review the data and to begin to anticipate questions. However, very little analysis could be done in this time. In both cases, the complete Public Data Release Reports could be completed and released after the release of the data. V. ISSUES AND CONSIDERATIONS Timing All things being equal, we would clearly like to make the TRI data available to the public as early as possible since data is more useful the more current it is. Since the reporting deadline is July 1 following the year for which the data is reported, there is a statutory 6 month delay before the data are submitted to EPA and the states. As is discussed in more detail in the paper describing the processing of the TRI data, the Agency takes a few months to enter the data and undertake quality assurance measures before freezing the data. This paper has discussed the process the Agency traditionally goes through to analyze the data and prepare reports summarizing and explaining the data. In order to release the data sooner after freezing the data, we would need to forego some or all of the analysis and report­ writing, which could have implications for the quality of the data, and the amount of analysis and context made available to the public. EPA is seeking comment on the timing of the data release, and on the preferred tradeoffs that should be made in order to change the timing of the data release. For instance, if a commenter feels strongly that the TRI data needs to be released at least 3 months earlier, we would like the commenter's suggestions regarding how to accomplish that, e. g., specific recommendations on scaling back or eliminating the data release reports Context EPA has always prepared its data analysis and some type of report prior to releasing the data. ­ 7­ In addition, some type of press announcement is always made at the time of the release to make people aware that the data is available. Over the years, many stakeholders have indicated that they feel it is important for the Agency to provide context when releasing the data since, otherwise, there could be a lot of room for misinterpretation. Providing this context adds to the time it takes to make the data available. EPA is seeking comment on the context currently provided when we release the TRI data, including specific recommendations for change. For instance, if you would like to see more context provided, please provide recommended additions. Extent of Data Analysis Given the huge volume of data in the TRI database, there is much analysis that can be done on it. However, the Agency is limited in the amount of analysis that can be done on the data because of the need to make the data available as quickly as possible. Therefore, there are many questions about the data which cannot be fully answered at the time of the data release. If we consider trying to accelerate the data release schedule, we need to recognize the fact that the Agency's analysis of the data will be even more limited than it has been. Therefore, questions may be raised about the data that cannot be answered immediately. EPA is seeking comment on the extent of the data analysis currently conducted as well as specific recommendations for change. If you are recommending that the Agency conduct additional analysis prior to releasing the data, please comment on your willingness to have the data released later than it currently is. Data Quality Assuring the quality of the TRI data has been, and continues to be an important aspect of the TRI Program. The utility of the data is dependent upon how credible it is. The most important data quality activities are discussed in the other issue papers. For example, the compliance assistance issue paper discusses the many TRI guidance documents, training workshops, the hotline, etc. The other issue paper addressing TRI data receipt and processing discusses several data quality steps taken prior to the data freeze. In addition, as the data is analyzed following the data freeze, additional quality assurance is undertaken. At this stage in the process, it is very difficult for the Agency to change the data since it has already been " frozen" and generally many analyses have already been performed. Therefore, if significant errors are discovered, the remedy is usually to explain them in a footnote. If EPA were to try and speed the release of the TRI data following the data release, data quality could be compromised to some extent. For example, in the process of developing the Public ­ 8­ Data Release and State Fact Sheets reports, EPA occasionally discovers significant errors, mostly resulting from erroneous submissions. If EPA were to simply make the data available through Envirofacts and TRI Explorer, it's unlikely these types of errors would be caught, partly due to the fact that we would not be having the states check the State Fact Sheet data. Options for expediting the TRI data release are likely to include eliminating or reengineering some of the data quality activities, and placing greater responsibility on the reporting facilities to submit their data correctly in the first place. This could compromise data quality in the short run as we move to the new approach, but could benefit the program in the long run. EPA is seeking comment on users' trade­ off preferences between data quality and timing of the data release. For instance, is expediting the release of the data important enough to users that they are willing to tolerate the possibility that there will be more errors in the data at the time of release? Digital Divide Given budget constraints, the growth of the Internet, and the pressure to make information available as quickly as possible, we have become more and more reliant on the Internet to make the TRI data available. We need to keep in mind that there are still many citizens that need the TRI data who cannot access it electronically very easily. Many of the options for expediting the release of the data rely exclusively on electronic data access. EPA is seeking comment on whether or not the digital divide is a significant issue, and if it is, how EPA should be addressing it with respect to the TRI public data release.

epa

2024-06-07T20:31:41.152153

regulations

EPA-HQ-OEI-2002-0006-0005

Supporting & Related Material

­ 1­ TRI COMPLIANCE ASSISTANCE PAPER for Stakeholder Outreach I. BACKGROUND This is one of three papers which describe aspects of the Toxics Release Inventory ( TRI) Program and raise issues for stakeholder input. The scope of each paper corresponds to a phase of the annual TRI reporting cycle. TRI data for a calendar year must be reported to EPA each year by July 1st after the end of the year. Therefore, reporting years are the same as calendar years. The " reporting cycle" begins with EPA's compliance assistance ( CA) activities, including the development of its reporting forms and instructions package. A courtesy copy of the reporting forms and instructions package is generally mailed to facilities in March of each year. Once EPA receives the forms, it enters the data from the forms ( more than 91,000 in 2000) in its TRI database. After entry into the database, EPA runs a number of data quality checks on both the facility identification information and on the chemical­ specific data. After the data entry and data quality steps are completed, the TRI database is " frozen" for analysis and development of data products for release to the public. Generally, EPA announces the annual release of the TRI data by holding a press event or issuing a press release, and simultaneously notifying a wide range of stakeholders. The first background paper for this stakeholder process is entitled TRI Data Collection, Processing and Management, and addresses the TRI data process beginning with submission of the forms and ending at the data " freeze." The TRI Data Release Issue Paper is the second of the three; it discusses TRI data products, the process for analyzing and releasing the TRI data, uses of the data, and issues and considerations associated with these aspects of the TRI Program. This paper, TRI Compliance Assistance Paper, which addresses TRI CA activities is the third paper. TRI CA activities are carried out throughout the year with certain activities being closely aligned with the reporting cycle. II. TRI COMPLIANCE ASSISTANCE ACTIVITIES CA includes activities, tools, or technical assistance that provides clear and consistent information to help the regulated community understand and meet its environmental regulatory obligations. By definition, CA includes finding cost­ effective ways to comply with regulations and/ or go beyond compliance through the use of pollution prevention, environmental management systems ( EMS), and innovative technologies, thus improving environmental performance. CA is a core function of the TRI Program and is critical to helping facilities understand regulatory requirements, and the submission ­ 2­ of accurate and high quality data. The key parts of the TRI CA program include: Reporting Forms & Instructions Every year the TRI Program publishes the Toxic Chemical Release Inventory Reporting Forms & Instructions guidance document ( http:// www. epa. gov/ tri/ report/ rfi2001. pdf) to provide the regulated community clear and concise information on how to accurately report their toxic chemical releases and other waste management activities to EPA pursuant to EPCRA section 313. This document is key in providing the regulated community with an overview of TRI reporting requirements and updates to reporting requirements from previous reporting years. EPA would like comments on the TRI Reporting Forms and Instructions, including how it meets the regulated communities' information and reporting needs, and suggestions for changes. TRI Made Easy ( TRI­ ME)/ TRI Assistance Library TRI­ ME ( http:// www. epa. gov/ tri/ report/ software/) is an interactive, intelligent, user­ friendly software tool that guides facilities through the TRI reporting experience. By leading prospective reporters through a series of logically ordered questions, TRI­ ME streamlines the user's analysis needed to determine if a facility must complete a Form R report or Form A Certification Statement for a particular chemical. For those facilities required to report, the software provides the user with guidance for each data element on the reporting forms. Additionally, TRI­ ME has a one­ stop guidance feature, the TRI Assistance Library ( which is also available separately ( http:// www. epa. gov/ tri/ report/ index. htm# guidance) that allows users to do keyword searches on the statutes, regulations, and many EPCRA section 313 guidance documents. For the more experienced reporter, TRI­ ME allows for direct data entry onto electronic versions of the Form R and Form A Certification Statement. TRI­ ME checks the data for common errors and then prepares the forms, on paper, magnetic media, or electronically over the Internet via the EPA's Central Data Exchange ( CDX) for submission to EPA. In the spring of 2002, EPA distributed more than 23,000 copies of TRI­ ME in preparation for the 2001 reporting year, and is working with facilities to continue to improve and upgrade this compliance tool for the 2002 reporting year. EPA works with TRI­ ME users to incorporate comments and suggestions on how subsequent versions can be made more helpful and easier to use. EPA would like comments on both TRI­ ME and the TRI Assistance Library including how they meet the regulated communities' reporting and information needs, and suggestions for ­ 3­ changes. Industry Training Workshops The TRI Industry Training Workshops ( provided by both headquarters and the EPA regions) ( http:// www. epa. gov/ tri/ report/ training/ index. htm) provide the regulated community with live training on the TRI regulatory requirements, guidance on how to complete the reporting Form R and the Form A Certification Statement, as well as an update on new program requirements and changes. In preparation for the 2001 reporting year, there were approximately 75 one­ and two­ day workshops held throughout the US and attended by more than 3,000 participants. Certain workshops have been designed for specific industry sectors ( e. g., mining, electric utilities, federal facilities), while others have been designed for the reporting of specific chemicals ( e. g., there were nine lead and lead compounds workshops which had more than 700 participants in preparation for the first year of reporting of lead and lead compounds at a lower threshold in 2001). The intent of the training workshops is to familiarize facilities with the reporting obligations they may have under section 313 of EPCRA and section 6607 of the PPA. Sessions present basic reporting requirements and a variety of hands­ on exercises using the reporting forms and supporting materials that assist participants in understanding their reporting obligations. Workshops have been designed for persons from facilities that operate in the industry sectors subject to EPCRA Section 313 and PPA Section 6607, persons from facilities that may be affected by the recent changes to the EPCRA section 313 and PPA section 6607 regulations, and persons from federal facilities and private sector facilities responsible for completing EPCRA section 313 reporting form( s), and consulting firms who may be assisting them. EPA would like comments on all aspects of the TRI Industry Training Workshops, including how they meet the regulated communities' training and information needs, and suggestions for changes. In addition, EPA would like comments on the possibility of other venues for providing the training, such as developing computer­ based training modules or privatizing TRI training in the future. Guidance Documents EPA provides industry­ specific, chemical­ specific and general guidance to assist the regulated community in fulfilling their reporting obligations under section 313 of EPCRA ( http:// www. epa. gov/ tri/ guide_ docs/ index. htm). Industry­ specific guidance provides general statutory ­ 4­ and regulatory guidance for specific industry sectors, in addition to industry­ specific reporting recommendations and emission factors. Chemical­ specific guidance explains the EPCRA Section 313 reporting requirements, and provides guidance on how to estimate annual releases and other waste management quantities of a particular chemical from certain industries and industrial activities. In addition, EPA has made available the " EPCRA Section 313 Questions and Answers" ( Q& A) document ( http:// www. epa. gov/ tri/ guide_ docs/ 1998/ 1998qa. pdf). The latest version of this document was published in 1998 and the Agency anticipates releasing an updated version in the summer of 2002. This document has been developed to clarify reporting requirements in conjunction with the statute and TRI regulations, including topics related to reporting requirements, exemptions, Form R calculations and submissions, supplier notification, trade secrets, and policy directives. EPA is currently in the process of updating the Q& A document. EPA has also developed guidance that assists facilities with specific aspects of the reporting process such as in revising/ withdrawing TRI submissions ( http:// www. epa. gov/ tri/ guide_ docs/ index. htm# general). EPA would like comments on all guidance documents, including how they meet the regulated communities' reporting and information needs, and suggestions for changes. Suggestions and comments can relate to specific guidance documents ( e. g., lead and lead compounds guidance document, metal mining guidance document), or general comments on the overall presentation of material ( e. g., understandable, accessible, appropriate reference information, helpful, etc.). Interpretive Guidance ( IG) Facilities are encouraged to and do write to the TRI Program directly, asking site­ specific questions relating to TRI reporting requirements. The TRI Program responds directly to facility questions through a formal interpretive guidance ( IG) process established by the TRI Program. EPA would like comments on the IG process, including how it meets the regulated communities' information needs, and suggestions for changes ( e. g., is there a need for public access to the IG database, can the Q& A guidance document be updated immediately with IG policy decisions). Compliance Assistance Outreach Activities At both EPA headquarters and the regional offices, the TRI Program spends a significant ­ 5­ amount of time providing outreach to assist the regulated community in fulfilling their reporting obligations under section 313 of EPCRA. Outreach activities ( e. g., meetings, conferences, answering phone calls, etc.) vary depending upon the needs of the region, the year of reporting ( e. g., PBT chemical reporting for the first time in RY 2000), and other factors. Depending upon the needs of the regulated community, EPA works with both individual facilities and industry groups to provided CA activities fore those required to report to TRI. EPA would like comments on the success of TRI CA outreach activities, including how they meet the regulated communities' information needs, and suggestions for changes ( e. g., are there other outreach activities that EPA could be doing to enhance CA?). TRI Website In 2002, the TRI Program redesigned ( http:// www. epa. gov/ tri/ site_ design. htm) the EPA TRI website ( http:// www. epa. gov/ tri) in an effort to provide easier and faster access to TRI information. The TRI website was redesigned to simplify access to TRI information for both the public and the regulated community. Depending upon the topic, CA information can be quickly accessed and downloaded. If individuals have additional questions, contact information is available ( HQ, EPA regional TRI coordinators, state TRI coordinators, EPCRA Hotline, TRI User Support, TRIDOCs). EPA would like comments on the recently redesigned TRI Website, including how it meets users' data and information needs, and suggestions for changes. EPCRA Call Center ( EPCRA Hotline) The TRI Program also offers reporting assistance to the regulated community through a telephone hotline, called the RCRA, Superfund and EPCRA Call Center. As the name implies, the call center is a one­ stop hotline that provides guidance on a variety of regulations. Operated Monday ­ Friday from 9: 00am to 5: 00pm ( eastern standard time), the regulated community can telephone the hotline to ask questions about how to comply with EPCRA section 313. The call center relies on written guidance, including guidance documents prepared by EPA and letters that respond to regulatory questions from the regulated community. Each year, the call center receives about 30,000 questions. A separate monthly survey conducted by the contractor who manages the call center shows high satisfaction with the call center: 63% of respondents indicated that they were strongly satisfied; 25% indicated they were mostly satisfied; 11% indicated they were satisfied; 1% indicated they were dissatisfied. In addition, the EPCRA Call Center maintains a free electronic mailing list server that E­ ­ 6­ mails EPCRA related documents/ information as they are published. EPA would like comments on the EPCRA Call Center, including how it meets users' data and information needs, and suggestions for changes. TRI­ User Support ( TRI­ US)/ TRI Documents TRI­ US provides a mechanism by which individuals who have questions or need assistance can contact EPA's TRI Program directly ( TRI­ US can be contacted at ( 202) 566­ 0250 or via E­ mail tri. us@ epa. gov). In addition, all TRI Documents can be obtained free by calling the TRIDOCS hotline ( 202) 564­ 9554. EPA would like comments on both TRI­ US and the TRIDOCS hotline, including how they meet the regulated communities' data and information needs, and suggestions for changes. III. EVALUATION In general, the CA activities outlined above have been implemented with very successful results. Many activities were initiated and modified in response to requests from the regulated community and other TRI stakeholders. In EPA's continued effort to improve CA to the regulated community, the TRI Program would like to evaluate the effectiveness of current CA activities with respect to the following: C Effectiveness for improving data quality; C Effectiveness for improving compliance with section 313 of EPCRA ( 40 CFR § 372) and section 6607 of the PPA ( i. e., TRI requirements); C Burden reduction ( i. e., the time/ effort it takes the regulated community to fulfill TRI requirements); and C Identification of gaps for new CA efforts or modification of existing tools. There are several ways which this evaluation can be completed. For example: C Conduct a survey/ interview of users of the TRI CA tools and CA providers, and follow­ up with a focus group meeting going over the results and generating new ideas; C Develop a correlation between TRI data and the implementation of CA tools ( e. g., develop a histogram between trends in TRI data and implementation of CA tools); and ­ 7­ C Evaluate use/ demand for the various CA tools ( e. g., number and types of callers to the EPCRA Call Center). Finally, EPA requests general comments on the overall successfulness of the TRI Program's CA activities. For example, which CA activities have been the most successful? Which have been the least successful, and why? Can the Agency more effectively use enforcement initiatives or targeting to: improve overall reporting; encourage reporting from non­ reporters; and receive better data ( i. e., focus not just on CA activities but the goal of better data). If cuts in CA activities are necessary, which CA activities should EPA continue to invest? Which CA activities should EPA disinvest, and why? Compliance assistance is targeted and delivered both by EPA headquarters and EPA regions. Is this successful? Is there significant variation in quality? In addition, EPA requests comments on any aspect of CA that may have not been mentioned above. For example, all of the CA activities outlined above have been provided by the TRI Program. Are there opportunities to develop CA activities through other Agency programs or efforts? For example, the TRI Program currently provides the CA information that it develops in a variety of ways, including through the program's web site, EPA's Compliance Assistance Centers, on EPA's regions websites, through requests to the EPCRA Call Center, TRI­ US, and TRI­ DOCS. What other opportunities exist to enhance CA for the regulated community reporting to TRI?

epa

2024-06-07T20:31:41.157362

regulations

EPA-HQ-OEI-2002-0010-0001

Notice

Overburden Exemption; Toxic Chemical Release Reporting; Community Right -To-Know; Administrative Procedure Act

63060 Federal Register / Vol. 67, No. 197 / Thursday, October 10, 2002 / Proposed Rules Prisons, we propose to amend 28 CFR part 549 as follows. SUBCHAPTER C INSTITUTIONAL MANAGEMENT PART 549 MEDICAL SERVICES 1. Revise the authority citation for 28 CFR 549 to read as follows: Authority: 5 U. S. C. 301; 18 U. S. C. 3621, 3622, 3624, 4001, 4005, 4014, 4042, 4045, 4081, 4082, ( Repealed in part as to offenses committed on or after November 1, 1987), 4241 4247, 5006 5024 ( Repealed October 12, 1984, as to offenses committed after that date), 5039; 28 U. S. C. 509, 510. 2. Add a new Subpart F to read as follows: Subpart F Fees for Health Care Services Sec. 549.70 Purpose and scope. 549.71 Inmates affected. 549.72 Services provided without fees. 549.73 Appealing the fee. 549.74 Inmates without funds. § 549.70 Purpose and scope. ( a) The Bureau of Prisons ( Bureau) may, under certain circumstances, charge you, an inmate under our care and custody, a fee for providing you with health care services. ( b) Generally, if you are an inmate as described in § 549.71, you must pay a fee for health care services of $ 2.00 per health care visit if you: ( 1) Receive health care services in connection with a health care visit that you requested, ( except for services described in § 549.72); or ( 2) Are found responsible through the Disciplinary Hearing Process to have injured an inmate who, as a result of the injury, requires a health care visit. § 549.71 Inmates affected. This subpart applies to: ( a) Any individual incarcerated in an institution under the Bureau's jurisdiction; or ( b) Any other individual, as designated by the Director, who has been charged with or convicted of an offense against the United States. § 549.72 Services provided without fees. We will not charge a fee for: ( a) Health care services based on staff referrals; ( b) Staff­ approved follow­ up treatment for a chronic condition; ( c) Preventive health care services; ( d) Emergency services; ( e) Prenatal care; ( f) Diagnosis or treatment of chronic infectious diseases; ( g) Mental health care; or ( g) Mental health care; or ( h) Substance abuse treatment. § 549.73 Appealing the fee. You may seek review through the Bureau's Administrative Remedy Program ( see 28 CFR part 542) if you disagree with either the fee charge or the amount. § 549.74 Inmates without funds. You will not be charged a health care service fee if you are considered indigent and unable to pay the health care service fee. The Warden may establish rules and processes to prevent abuses of this provision. [ FR Doc. 02 25850 Filed 10 9 02; 8: 45 am] BILLING CODE 4410 05 P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 372 [ OEI 2002 0010; FRL 6724 4] Overburden Exemption; Toxic Chemical Release Reporting; Community Right­ to­ Know; Administrative Procedure Act AGENCY: Environmental Protection Agency ( EPA). ACTION: Denial of petition. SUMMARY: EPA is denying an Administrative Procedure Act ( APA) petition to modify its definition of `` overburden'' to include both consolidated and unconsolidated material. Currently, unconsolidated material is eligible for the overburden exemption to reporting required under section 313 of the Emergency Planning and Community Right­ to­ Know Act of 1986 ( EPCRA) and section 6607 of the Pollution Prevention Act of 1990 ( PPA). Specifically, EPA is denying this petition because EPA's review of the petition and available information resulted in the conclusion that consolidated rock includes materials that often contain toxic chemicals above negligible amounts, often in significant quantities. FOR FURTHER INFORMATION CONTACT: Peter South, Petition Manager, U. S. Environmental Protection Agency, Mail Code 2844T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, 202 566 0745, e­ mail: south. peter@ epa. gov. For specific information on this document, or for more information on EPCRA section 313, contact the Emergency Planning and Community Right­ to­ Know Hotline, U. S. Environmental Protection Agency, Mail Code 5101, 1200 Pennsylvania Ave., NW., Washington, DC 20460, Toll free: 1 800 535 0202, in Virginia and Alaska: 703 412 9877 or Toll free TDD: 1 800 553 7672. Information concerning this notice is also available on EPA's Web site at http:// www. epa. gov/ tri. SUPPLEMENTARY INFORMATION: I. General Information A. Does This Action Apply to Me? This notice does not make any changes to existing regulations. However, you may be affected by this notice if you are a metal mining facility, or a facility that carries out metal mining activities. Potentially affected categories and entities may include, but are not limited to: Category Examples of potentially interested entities Industry .......... Metal mining facilities that remove and manage overburden and waste rock to access target ore; SIC major group codes 10 ( except 1011, 1081, and 1094). Federal Government Federal facilities. This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. To determine whether your facility would be affected by this action, you should carefully examine the applicability criteria in part 372, subpart B of Title 40 of the Code of Federal Regulations ( CFR). If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section. B. How Can I Get Copies Of This Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under Docket ID No. OEI 2002 0010. The public docket includes information considered by EPA in developing this action, including the documents listed below, which are physically located in the docket. In addition, interested parties should consult documents that are referenced in the documents that EPA has placed in the docket, regardless of whether these referenced documents are physically located in the docket. For assistance in locating documents that are referenced in documents that EPA has placed in the docket, but that are not physically located in the docket, please consult the person listed in the VerDate 0ct< 02> 2002 23: 11 Oct 09, 2002 Jkt 200001 PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 E:\ FR\ FM\ 10OCP1. SGM 10OCP1 63061 Federal Register / Vol. 67, No. 197 / Thursday, October 10, 2002 / Proposed Rules preceding FOR FURTHER INFORMATION CONTACT section. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Overburden Exemption Docket in the EPA Docket Center, ( EPA/ DC) EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1742, and the telephone number for the Overburden Exemption Docket is ( 202) 566 1752. 2. Electronic Access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. Once in the system, select `` search,'' then key in the appropriate docket identification number. II. Introduction A. What Is the Statutory Authority for This Action? This action is taken under the Administrative Procedure Act ( APA), 5 U. S. C. secs 551 559, 701 706. B. What Is the General Background for This Action? Section 313 of EPCRA requires certain facilities manufacturing, processing, or otherwise using listed toxic chemicals in amounts above reporting threshold levels, to report their environmental releases of such chemicals annually. These facilities must also report pollution prevention and recycling data for such chemicals, pursuant to section 6607 of the Pollution Prevention Act of 1990 ( PPA), 42 U. S. C. 13106. On May 1, 1997, EPA added metal mining and six other industry groups to the list of facilities subject to the reporting requirements of section 313 of EPCRA. 62 FR 23833. EPA added these groups in order to enhance the public's knowledge about the use and disposition of toxic chemicals in their communities. EPA defines `` overburden'' as `` the unconsolidated material that overlies a deposit of useful materials or ores.'' 40 CFR 372.3. Due to the Agency's understanding that overburden contained EPCRA section 313 chemicals in negligible amounts and that reporting was unlikely to provide the public with information valuable enough to warrant reporting, EPA exempted EPCRA section 313 chemicals in overburden from EPCRA section 313 and PPA section 6607 reporting requirements. EPA does not require compliance determinations or reporting of releases or other waste management information for listed chemicals which exist in overburden removed prior to removal of waste rock or extraction of the target ore. The Agency's rationale in providing the overburden exemption, as defined above, was dependent on EPA's understanding that overburden contained toxic chemicals only in negligible amounts, and therefore was unlikely to generate any reporting. 62 FR 23859. The same, however, could not be determined for consolidated rock, and therefore EPA did not extend the exemption to this material. Id. III. What Does This Petition Request of the Agency? EPA received a petition from the National Mining Association ( NMA) on December 22, 1998, and additional information in a letter on May 7, 1999. NMA petitioned the Agency to modify the EPCRA section 313 definition of `` overburden'' to include both consolidated and unconsolidated material. Refs. 1 and 2. Currently, only unconsolidated material is considered as overburden under the Toxics Release Inventory ( TRI) program, and therefore only unconsolidated material is eligible for the overburden exemption under EPCRA section 313. NMA asserts that the EPCRA section 313 definition of overburden is inconsistent with that of the mining industry, the body of technical evidence, leading technical authorities, and other federal regulatory definitions. Refs. 1 and 2. NMA considers overburden to include both the consolidated and unconsolidated material that overlies an ore deposit. NMA petitioned EPA to include consolidated material in addition to unconsolidated material in the definition of overburden under EPCRA section 313 and thus make consolidated material eligible for the overburden exemption. NMA cites two technical references: the American Geological Institute ( AGI) Dictionary of Mining, Mineral, and Related Terms, Ref. 3, and the Glossary of Selected Geologic Terms with Special Reference to Their Use in Engineering, Ref. 4. The AGI defines overburden as: overburden ( a) Designates material of any nature, consolidated or unconsolidated, that overlies a deposit of useful materials, ores, or coal esp. those deposits that are mined from the surface by open cuts. ( Stokes, 1955) ( b) Loose soil, sand, gravel, etc. that lies above the bedrock. Also called burden, capping cover, drift, mantle, surface. See also: baring; burden; top. ( Stokes, 1955). Ref. 3. The Glossary of Selected Geologic Terms with Special Reference to Their Use in Engineering, by W. L Stokes and D. J. Varnes, defines overburden as: overburden, n. A term used by geologists and engineers in several different senses. By some it is used to designate material of any nature, consolidated or unconsolidated, that overlies a deposit of useful materials, ores, or coal, especially those deposits that are mined from the surface by open cuts. As employed by others overburden designates only loose soil, sand, gravel, etc., that lies above the bedrock. The term should not be used without specific definition. Ref. 4. In addition, NMA cites two EPA definitions and four other federal regulatory definitions that define overburden to include both consolidated and unconsolidated material. The EPA's National Pollutant Discharge Elimination System ( NPDES) ( 40 CFR 122.26( b)( 10)) defines overburden as: Overburden means any material of any nature, consolidated or unconsolidated, that overlies a mineral deposit, excluding topsoil or similar naturally­ occurring surface materials that are not disturbed by mining operations. Ref. 2. EPA's Office of Solid Waste ( OSW) 1985 Report to Congress: Wastes from the Extraction and Beneficiation of Metallic Ores, Phosphate Rock, Asbestos, Overburden from Uranium Mining, and Oil Shale defines overburden as: `` consolidated or unconsolidated material overlying the mined area.'' Ref. 5. The other federal agency definitions include: the Mine Safety and Health Administration ( MSHA), the Office of Surface Mining ( OSM), the Bureau of Land Management ( BLM), and the Bureau of Indian Affairs ( BIA). Ref. 2. VerDate 0ct< 02> 2002 23: 11 Oct 09, 2002 Jkt 200001 PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 E:\ FR\ FM\ 10OCP1. SGM 10OCP1 63062 Federal Register / Vol. 67, No. 197 / Thursday, October 10, 2002 / Proposed Rules IV. What Is the Regulatory Status of the Overburden Exemption? The regulatory definition of overburden under EPCRA section 313 is the unconsolidated material that overlies a deposit of useful materials or ores. 40 CFR 372.3. In most cases, overburden contains EPCRA section 313 chemicals in negligible amounts and reporting is unlikely to provide the public with sufficient valuable information to justify reporting. In contrast, waste rock ( including consolidated rock) may be acidgenerating and may contain toxic metals above negligible amounts that after release can be mobilized and be transported through the environment. EPA considers waste rock ( including consolidated rock) as distinct from overburden for purposes of reporting under EPCRA section 313. 62 FR 23859. In fact, EPA's definition of overburden specifically excludes waste rock: `` It [ overburden] does not include any portion of the ore or waste rock.'' 40 CFR 372.3. Waste rock ( including consolidated rock) is generally considered that portion of the ore body that is barren or submarginal rock or ore which has been mined but under normal conditions is not considered of sufficient value to warrant treatment. Waste rock is part of the ore body and may, depending upon economic conditions, become a valuable source of metal. Waste rock ( including consolidated rock) may also be further distributed in commerce for other uses such as road construction. Although waste rock ( including consolidated rock) may typically contain lower concentrations of metals and other constituents than the target ore, it often contains toxic chemicals above negligible amounts. V. What Is EPA's Rationale for Denial? In adding metal mining to the list of facilities subject to the reporting requirements of EPCRA section 313 ( 62 FR 23833), EPA provided the overburden exemption due to the Agency's understanding that overburden contained EPCRA section 313 chemicals in negligible amounts and that reporting was unlikely to provide the public with sufficient valuable information to justify reporting. EPA was not able to make the same determination for the consolidated rock that surrounds the ore body or the ore body itself. Therefore, the Agency specifically defined overburden to only include `` unconsolidated material that overlies a deposit of useful materials or ores.'' 40 CFR 372.3. The Agency specifically did not exempt consolidated mining material ( i. e., waste rock, including consolidated rock) due to EPA's understanding that consolidated rock and/ or waste rock often contains toxic chemicals above negligible amounts. Neither the petition submitted by NMA nor the documents which define overburden in a broader manner than the TRI program contain information that would allow EPA to change its conclusion. Without that type of information, EPA is unwilling to extend an exemption to materials which contain toxic chemicals above negligible amounts and for which reporting is likely to provide the public with valuable information. EPA's determination relies on the legal doctrine of the de minimis non curat lex: `` the law does not concern itself with trifling matters,'' Alabama Power Co. v. Costle, 636 F. 2d 323, 360 ( D. C. Cir. 1979). The de minimis principle recognizes that most regulatory statutes permit the `` implication'' that an agency has the authority to craft exemptions `` when the burdens of regulation yield a gain of trivial or no value.'' Alabama Power, 636 F .2d at 360 61. EPA has found no information to conclude that consolidated mining material contains EPCRA section 313 chemicals in only negligible amounts. As such, EPA limited this particular exemption to include overburden as defined under EPCRA section 313 ( i. e., unconsolidated material) and did not extend it to consolidated material ( i. e., waste rock including consolidated rock) which often contains EPCRA section 313 toxic chemicals above negligible amounts. Furthermore, after they are released, the metals that are contained in waste rock and consolidated rock can be mobilized and transported through the environment. Significant human health and environmental damages are caused by the management of mining wastes ( i. e., extraction and beneficiation). Refs. 6, 7, and 8. Therefore, reporting on these materials will be valuable to the public. In addition, NMA's proposed basis for expansion of the TRI definition of overburden that EPA's definition is inconsistent with that of the industry is not persuasive. Both the AGI definition and the Stokes and Varnes definition provide similar two­ part subdefinitions that are significantly different. Although the first subdefinition provided by AGI is consistent with NMA's assertion that overburden can contain both consolidated and unconsolidated material, the second sub­ definition clearly supports EPA's understanding that overburden is also defined to include only loose material ( e. g., `` Loose soil, sand, gravel, etc. that lies above the bedrock.''). Stokes and Varnes provide a similar two­ part definition by recognizing two equally acceptable definitions of the term overburden. Stokes and Varnes define overburden as ( a) ``* * * material of any nature, consolidated or unconsolidated * * *'' and ( b) `` only loose soil, sand, gravel, etc., that lies above bedrock.'' In addition, Stokes and Varnes highlight the fact that the term overburden should not be used without `` specific definition,'' which EPA provided in the initial rule. Although the term overburden is used by certain government and industry groups to include both consolidated and unconsolidated material, EPA's current definition for the TRI program that overburden includes only unconsolidated material is clearly consistent with the leading technical industry references. As was noted by Stokes and Varnes, the term overburden can accurately be defined to include only unconsolidated material. It is critical, however, when using the term to provide specific definition. In addition, NMA asserts that the EPCRA section 313 definition of overburden is inconsistent with EPA's Office of Solid Waste ( OSW) 1985 Report to Congress, Wastes from the Extraction and Beneficiation of Metallic Ores, Phosphate Rock, Asbestos, Overburden from Uranium Mining, and Oil Shale. The 1985 Report to Congress defines overburden as the `` consolidated or unconsolidated material overlying the mined area.'' Ref. 5. From a regulatory standpoint under the Resource Conservation and Recovery Act ( RCRA) ( 42 U. S. C. 6901 6992k), all overburden which is not returned to the pit is a component of the term mine waste. The 1985 Report to Congress defines mine waste as `` the soil or rock that mining operations generate during the process of gaining access to an ore or mineral body, and includes the overburden ( consolidated or unconsolidated material overlying the mined area) from surface mines, underground mine development rock ( rock removed while sinking shafts, accessing, or exploiting the ore body), and other waste rock, including the rock interbedded with the ore or mineral body.'' Ref. 5. Mine waste is a RCRA solid waste, but is exempt from regulation as a hazardous waste. 40 CFR 261.4( b)( 7). The 1985 Report to Congress reflects the understanding the Agency had at the time on the nature and types of mining wastes. The 1985 Report to Congress did, however, clearly point out the Agency's concerns that overburden and other types of mine wastes had caused VerDate 0ct< 02> 2002 23: 11 Oct 09, 2002 Jkt 200001 PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 E:\ FR\ FM\ 10OCP1. SGM 10OCP1 63063 Federal Register / Vol. 67, No. 197 / Thursday, October 10, 2002 / Proposed Rules significant environmental damages. Since then, as a result of the Bevill rulemakings ( 54 FR 36592 September 1, 1989; 55 FR 2322, January 23, 1990; 56 FR 27300, June 13, 1991) and the Land Disposal Restrictions Phase IV rulemaking ( 63 FR 28556, May 26, 1998), the Agency has significantly improved its understanding of the nature and types of mining wastes. The Bevill rulemakings were promulgated to establish a regulatory approach to identify the differences between extraction/ beneficiation wastes from mineral processing wastes. The Agency's most recent assessment of the environmental risks posed by mining waste confirms the Agency's 1985 concerns and indicates that mine waste continues to cause environmental damage throughout the U. S. Refs. 7 and 8. NMA also asserts that the EPCRA section 313 definition of overburden is inconsistent with EPA's National Pollutant Discharge Elimination System ( NPDES) ( CFR 122.26( b)( 10)) and other federal agency definitions, including: the Mine Safety and Health Administration ( MSHA), the Office of Surface Mining ( OSM), the Bureau of Land Management ( BLM), and the Bureau of Indian Affairs ( BIA). Ref. 2. Because the statutes governing these programs and the purposes of these programs are different from those for the TRI program, it is reasonable for the TRI program to define overburden differently than other programs. Clearly, the purpose of each of these programs ( direct regulation) is quite different from the purposes related to the reporting of releases and other waste management under EPCRA section 313 ( information collection and dissemination). The TRI program was established by Congress under EPCRA section 313 in response to public demand for information on toxic chemicals being released in their communities. For example, in a study of 306 of the approximately 1,000 operating hard rock mines in the U. S., EPA found that approximately 228,145 people ( including 55,374 children under the age of four) and 89,335 households live within 1 mile of one of the 306 active mine sites. Ref. 9. The entire concept of the TRI program is founded on the belief that the public has the right to know about chemical usage and release in the areas in which they live, as well as the hazards that may be associated with these chemicals. As such, it is reasonable that the EPCRA section 313 program defines overburden differently than other federal regulatory programs. In the TRI Program's final facility expansion rulemaking ( 62 FR 23833), EPA determined that it was important for the communities that surrounded mining facilities to have information on the releases and other waste management activities that are associated with those facilities. A broader interpretation of the EPCRA section 313 definition of overburden would result in significantly less information being transmitted to these communities. Recognizing that the purpose of EPCRA section 313 is to provide information to the public, it is reasonable for the TRI program to have more narrowly defined the term overburden and therefore the scope of the overburden exemption in order to accomplish the goals of the facility expansion rulemaking, the TRI program, and the statute. In conclusion, NMA makes the argument that the EPCRA section 313 definition of overburden is inconsistent with that of the mining industry, the body of technical evidence, leading technical authorities, and other federal regulatory definitions. As stated above, NMA's argument is not persuasive because the EPCRA definition of overburden is actually consistent with leading technical industry references. Neither the petition submitted by NMA nor the documents which define overburden in a broader manner than the TRI program contain information that would allow EPA to change its conclusion that consolidated rock and/ or waste rock often contain toxic chemicals above negligible amounts. Without that type of information, EPA is unwilling to extend an exemption to materials which contain toxic chemicals above negligible amounts and for which reporting is likely to provide the public with valuable information. Therefore, EPA is denying this petition. VI. What Are the References Cited in This Notice? 1. National Mining Association. Letter entitled: EPA Response to NMA Queries. December 22, 1998. 2. National Mining Association. Letter entitled: December 22, 1998, NMA Petition on TRI Regulatory Definition of `` Overburden.'' May 7, 1999. 3. American Geological Institute. Dictionary of Mining, Mineral, and Related Terms, 2nd Edition, American Geological Institute ( 1997). 4. Stokes, W. L. and Varnes, D. J. Glossary of Selected Geologic Terms With Special Reference to Their Use in Engineering, Colorado Scientific Society Proceedings, Vol. 16, ( 1955). 5. U. S. EPA. Report to Congress, Wastes from the Extraction and Beneficiation of Metallic Ores, Phosphate Rock, Asbestos, Overburden from Uranium Mining, and Oil Shale, U. S. Environmental Protection Agency, EPA 530 SW 85 033 ( December 31, 1985). 6. U. S. EPA/ Region 10. EPA and Hard Rock Mining: A Source Book for Industry in the Northwest and Alaska ( Draft), U. S. Environmental Protection Agency, EPA 910 R 99 016 ( November 1999). 7. U. S. EPA/ Office of Solid Waste. Human Health and Environmental Damages from Mining and Mineral Processing Wastes, U. S. Environmental Protection Agency, Technical Background Document Supporting the Final Rule: Land Disposal Restrictions Phase IV: Final Rule Promulgating Treatment Standards for Metal Wastes and Mineral Processing Wastes; Mineral Processing Secondary Materials and Bevill Exclusion Issues; Treatment Standards for Hazardous Soils, and Exclusion of Recycled Wood Preserving Wastewaters, RCRA Docket No. F 98 2P4F FFFFF ( April 1998). 8. U. S. EPA/ Office of Solid Waste. Damage Cases and Environmental Releases from Mines and Mineral Processing Sites, U. S. Environmental Protection Agency, Technical Background Document Supporting the Final Rule: Land Disposal Restrictions Phase IV: Final Rule Promulgating Treatment Standards for Metal Wastes and Mineral Processing Wastes; Mineral Processing Secondary Materials and Bevill Exclusion Issues; Treatment Standards for Hazardous Soils, and Exclusion of Recycled Wood Preserving Wastewaters, RCRA Docket No. F 98 2P4F FFFFF ( April 1998). 9. U. S. EPA/ Office of Solid Waste. Population Studies of Mines and Mineral Processing Sites, U. S. Environmental Protection Agency, Technical Background Document Supporting the Final Rule: Land Disposal Restrictions Phase IV: Final Rule Promulgating Treatment Standards for Metal Wastes and Mineral Processing Wastes; Mineral Processing Secondary Materials and Bevill Exclusion Issues; Treatment Standards for Hazardous Soils, and Exclusion of Recycled Wood Preserving Wastewaters, RCRA Docket No. F 98 2P4F FFFFF ( April 1998). VII. What Are the Regulatory Assessment Requirements for This Action? A. Executive Order 12866 This action does not require review by the Office of Management and Budget ( OMB) under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993), VerDate 0ct< 02> 2002 23: 11 Oct 09, 2002 Jkt 200001 PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 E:\ FR\ FM\ 10OCP1. SGM 10OCP1 63064 Federal Register / Vol. 67, No. 197 / Thursday, October 10, 2002 / Proposed Rules because denial of an APA rulemaking petition is not a `` significant regulatory action'' subject to review by OMB under E. O. 12866. B. Regulatory Flexibility Act Pursuant to section 605( b) of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.), the Agency hereby certifies that this denial will not have a significant impact on a substantial number of small entities. This determination is based on the fact that this denial will not result in any adverse economic impacts on the facilities subject to reporting under EPCRA section 313, regardless of the size of the facility. C. Paperwork Reduction Act This petition denial will not reduce or increase the overall reporting and record keeping burden estimate provided for the TRI program, and does not require any review or approval by OMB under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq. As such, it is not necessary for EPA to determine the total TRI burden associated with this action. The reporting and record keeping burdens associated with TRI are approved by OMB under OMB No. 2070 0093 ( Form R, EPA ICR No. 1363) and under OMB No. 2070 0145 ( Form A, EPA ICR No. 1704). The current public reporting burden for TRI is estimated to average 52.1 hours for a Form R submitter and 34.6 hours for a Form A submitter. These estimates include the time needed for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection appears above. In addition, the OMB control number for EPA's regulations, after initial display in the final rule, are displayed on the collection instruments and are also listed in 40 CFR part 9. D. Unfunded Mandates Reform Act and Executive Orders 13084 and 13132 Since this action involves the denial of an APA rulemaking petition, it does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments as described in the Unfunded Mandates Reform Act of 1995 ( Pub. L. 104 4). For the same reason, it is not subject to the requirement for prior consultation with Indian tribal governments as specified in Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments ( 63 FR 27655, May 19,1998). Nor will this action have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). E. Executive Order 12898 Pursuant to Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low­ Income Populations ( 59 FR 7629, February 16, 1994), the Agency must consider environmental justice related issues with regard to the potential impacts of this action on environmental and health conditions in low­ income populations and minority populations. The Agency has determined that this action will not result in environmental justice related issues. F. Executive Order 13045 Pursuant to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997), if an action is economically significant under Executive Order 12866, the Agency must, to the extent permitted by law and consistent with the Agency's mission, identify and assess the environmental health risks and safety risks that may disproportionately affect children. Since this action is not economically significant under Executive Order 12866, this action is not subject to Executive Order 13045. G. National Technology Transfer and Advancement Act Section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA) ( 15 U. S. C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless doing so would be inconsistent with applicable law or impractical. Voluntary consensus standards are technical standards ( e. g., materials specifications, test methods, sampling procedures, etc.) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This action does not involve technical standards, nor did EPA consider the use of any voluntary consensus standards. In general, EPCRA does not prescribe technical standards to be used for threshold determinations or completion of EPCRA section 313 reports. EPCRA section 313( g)( 2) states that `` In order to provide the information required under this section, the owner or operator of a facility may use readily available data ( including monitoring data) collected pursuant to other provisions of law, or, where such data are not readily available, reasonable estimates of the amounts involved. Nothing in this section requires the monitoring or measurement of the quantities, concentration, or frequency of any toxic chemical released into the environment beyond that monitoring and measurement required under other provisions of law or regulation.'' List of Subjects in 40 CFR Part 372 Environmental protection, Community right­ to­ know, Reporting and recordkeeping requirements, and Toxic chemicals. Dated: September 19, 2002. Kimberly T. Nelson, Assistant Administrator, Office of Environmental Information. [ FR Doc. 02 25851 Filed 10 9 02; 8: 45 am] BILLING CODE 6560 50 P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 RIN 1018 AH94 Endangered and Threatened Wildlife and Plants; Designation of Critical Habitat for Blackburn's Sphinx Moth AGENCY: Fish and Wildlife Service, Interior. ACTION: Proposed rule; public hearing announcement. SUMMARY: The U. S. Fish and Wildlife Service ( Service) gives notice of a public hearing on the proposed critical habitat designation for Blackburn's sphinx moth ( Manduca blackburni). The public hearing on the island of Hawaii and extension of the comment period will allow all interested parties to submit oral or written comments on the proposal. We are seeking comments or suggestions from the public, other concerned agencies, the scientific community, industry, or any other interested parties concerning the proposed rule. Comments already submitted on the proposed rule need not be resubmitted as they will be fully considered in the final determination. VerDate 0ct< 02> 2002 23: 11 Oct 09, 2002 Jkt 200001 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 E:\ FR\ FM\ 10OCP1. SGM 10OCP1

epa

2024-06-07T20:31:41.162057

regulations

EPA-HQ-OEI-2002-0015-0001

Notice

Toxic Chemical Release Reporting; Community Right-to- Know; Request for Comment on Change of Contractor Handling Trade Secret Claims

65566 Federal Register / Vol. 67, No. 207 / Friday, October 25, 2002 / Notices Long Island and New York City, New Haven, CT and Suffolk County, NY. Summary: EPA expressed environmental concerns that the FEIS lacks information to understand impacts to wetlands and waters of the US; disagreed with the conclusion that project construction and operation will result in limited adverse environmental impacts; expressed concerns about marine impacts and encouraged close coordination between FERC and the applicant with land trust/ conservation organizations along the proposed pipeline route. ERP No. F FRC B05192 ME, Presumpscot River Projects, Relicensing of Five Hydroelectric Projects for Construction and Operation, Dundee Project ( FERC No. 2942); Gambo Project ( FERC No. 2931); Little Falls Project ( FERC No. 2932); Mallison Falls Project ( FERC No. 2941) and Saccarappa Project ( FERC No. 2897), Cumberland County, ME. Summary: EPA expressed outstanding environmental concerns about dam removal effects on water quality and recommended that higher flows be considered at the Dundee and Mallison Falls dams. EPA also continued to urge consistency with the Casco Bay Estuary Project. ERP No. F FRC L03011 WA, Georgia Strait Crossing Pipeline ( LP) Project, Construction and Operation to Transport Natural Gas from the Canadian Border near Sumas, WA to US/ Canada Border at Boundary Pass in the Strait of Georgia, Docket Nos. CP01 176 000 and CP01 179 000, Whatcom and San Juan Counties, WA. Summary: EPA continues to have significant environmental objections with the proposal given the lack of evaluation of reasonable alternatives, the lack of integration with the evaluation and decision making processes being conducted in Canada for the Canadian portion of the project, and the high risks associated with seismic hazards. ERP No. F FRC L05220 WA, Warm Creek ( No. 10865) and Clearwater Creek ( No. 11485) Hydroelectric Project, Issuance of License for the Construction and Operation located in the Middle Fork Nooksack River ( MFNR) Basin, WA. Summary: EPA raised environmental objections regarding the proposed projects, including the potential negative impacts to aquatic and terrestrial endangered species, and adverse effects to old growth forest, water quality and cultural and spiritual resources of affected Tribes. EPA recommended that the FERC select the No Action alternative. ERP No. F FRC L05222 ID, Four Mid­ Snake River Hydroelectric Projects, Applications for New License for the Existing Projects: Shoshone Falls­ FERC No. 2778, Upper Salmon Falls­ FERC No. 2777, Lower Salmon Falls­ FERC No. 2061 and Bliss­ FERC No. 1975, Snake River, ID. Summary: EPA expressed environmental objections that the final EIS did not identify a preferred alternative. EPA continues to have objections to the No Action alternative, the Applicant Proposed Project, and the Seasonal Run­ of­ River alternative as they would result in continued negative effects to native fish, aquatic invertebrates, and riparian and wetland habitats. EPA recommended licensing and implementing the Year­ Round Runof River alternative. ERP No. F IBR J39029 SD, Angostura Unit ( Dam, Reservoir and Irrigation Facilities) Renewal of a Long­ Term Water Service Contract, Cheyenne River Basin, Pine Ridge Reservation, Bismarck County, SD. Summary: No formal comment letter was sent to the preparing agency. ERP No. F NRS G36154 OK, Rehabilitation of Aging Flood Control Dams in Oklahoma, Authorization and Funding, OK. Summary: EPA has no objection to the proposed action since the document adequately responded to comments offered on the Draft EIS. ERP No. FA COE H36012 MO, St. Johns Bayou and New Madrid Floodway Project, Channel Enlargement and Improvement, Flood Control and National Economic Development ( NED), New Madrid, Mississippi and Scott Counties, MO. Summary: EPA continues to have environmental objections to the project and believes that the recommended plan ( alternative 3 1. B) raises substantive environmental issues. ERP No. FS COE F36163 00, Upper Des Plaines River, Flood Damage Reduction at Site 37, Construction of a Concrete Floodwall along Des Plaines River, Milwaukee Avenue, Willow Road and Palatine Road in Mt. Prospect, Cook County, IL. Summary: EPA had no objections to the proposed project and commended the Corps on their wetland mitigation proposal. Dated: October 22, 2002. Joseph C. Montgomery, Director, NEPA Compliance Division, Office of Federal Activities. [ FR Doc. 02 27264 Filed 10 24 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OEI 2002 0010; FRL 6724 7] Toxic Chemical Release Reporting; Community Right­ to­ Know; Request for Comment on Change of Contractor Handling Trade Secret Claims AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces an upcoming change in location and contractor designated to manage the Toxics Release Inventory ( TRI) data processing for all TRI submissions including TRI Trade Secret and confidential information submitted pursuant to 40 CFR part 350. In compliance with 40 CFR part 350 (`` Trade Secrecy Claims for Emergency Planning and Community Right­ to­ Know Information'') facilities submitting TRI reports may be eligible to claim Trade Secret for the specific chemical identity of a toxic chemical being reported. Pursuant to 40 CFR 350.23 (`` Disclosure to authorized representatives''), information entitled to trade secret or confidential treatment may not be disclosed by the Agency to the Agency's authorized representative until each affected submitter has been furnished notice of the contemplated disclosure by the EPA program office and has been afforded a period found reasonable by that office ( not less than five working days) to submit its comments. Pursuant to this Federal Register notice, comments are limited to the change of contractor handling trade secret and confidential information submitted under 40 CFR part 350. Once the transition to the new location has been completed, information regarding the new mailing address will be posted on the TRI Web site ( http:// www. epa. gov/ tri) and will be included in the 2002 Toxic Chemical Release Inventory Reporting Forms and Instructions. DATES: Comments, identified by the docket control number OEI 2002 0010, must be submitted on or before 5 working days after publication in the Federal Register. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit III. of the SUPPLEMENTARY INFORMATION section of this notice. FOR FURTHER INFORMATION CONTACT: For general information, contact The Emergency Planning and Community VerDate 0ct< 09> 2002 15: 17 Oct 24, 2002 Jkt 200001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 25OCN1. SGM 25OCN1 65567 Federal Register / Vol. 67, No. 207 / Friday, October 25, 2002 / Notices Right­ to­ Know Hotline at ( 800) 424 9346 or ( 703) 412 9810, TDD ( 800) 553 7672, http:// www. epa. gov/ epaoswer/ hotline/. For technical information about this change in contractor and location for TRI data processing, contact: Wendy Timm, Toxics Release Inventory Program Division, OEI ( 2844T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460, Telephone: 202 566 0725; Fax: 202 566 0727; email: timm. wendy@ epa. gov. Once the transition to the new location has been completed, information regarding the new mailing address will be posted on the TRI Web site ( http:// www. epa. gov/ tri) and will be included in the 2002 Toxic Chemical Release Inventory Reporting Forms and Instructions. SUPPLEMENTARY INFORMATION: I. Does This Notice Apply to Me? A. Affected Entities: Entities that will be affected by this action are those facilities that manufacture, process, or otherwise use certain toxic chemicals listed on the Toxics Release Inventory ( TRI) and which are required under section 313 of the Emergency Planning and Community Right­ to­ Know Act ( EPCRA) of 1986, to report annually to EPA their environmental releases of such chemicals. Currently, those industries with the following SIC code designations ( that meet all other threshold criteria for TRI reporting) must report toxic chemical releases and other waste management activities: 20 39, manufacturing sector 10, metal mining ( except for SIC codes 1011, 1081, and 1094) 12, coal mining ( except for SIC code 1241 and extraction activities) 4911, 4931 and 4939, electrical utilities that combust coal and/ or oil for the purpose of generating power for distribution in commerce. 4953, RCRA Subtitle C hazardous waste treatment and disposal facilities 5169, chemicals and allied products wholesale distributors 5171, petroleum bulk plants and terminals 7389, solvent recovery services, and Federal facilities in any SIC code To determine whether you or your business is affected by this action, you should carefully examine the applicability provisions at 40 CFR part 350 and 40 CFR part 372. If you have any questions regarding the applicability of this action to a particular entity, consult the person( s) listed in the FOR FURTHER INFORMATION CONTACT section. II. How Can I Get Copies of This Document and Other Related Information? A. Docket. EPA has established an official public docket for this action under Docket ID No. OEI 2002 0010. The public docket includes information considered by EPA in developing this action, including the documents listed below, which are physically located in the docket. In addition, interested parties should consult documents that are referenced in the documents that EPA has placed in the docket, regardless of whether these referenced documents are physically located in the docket. For assistance in locating documents that are referenced in documents that EPA has placed in the docket, but that are not physically located in the docket, please consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the EPA Docket Center, ( EPA/ DC) EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1742, and the telephone number for the Notice of Change of Contractor Handling TRI Submissions including TRI Trade Secret Claims Docket is ( 202) 566 1752. B. Electronic Access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit II. A. Once in the system, select `` search,'' then key in the appropriate docket identification number. III. How Can I Respond to This Notice? A. How and To Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. Be sure to identify the appropriate docket control number ( i. e., OEI 2002 0010) in your correspondence. 1. By mail. All comments should be sent in triplicate to: Office of Environmental Information ( OEI/ TRI), Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania Ave., NW., Ariel Rios Building, Washington, DC 20460. 2. In person or by courier. Comments may be delivered in person or by courier to: EPA Docket Center, ( EPA/ DC) EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The DCO is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is ( 202) 260 7093. 3. Electronically. Submit your comments electronically by e­ mail to: `` oei. docket@ epa. gov''. Please note that you should not submit any information electronically that you consider to be CBI. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on standard computer disks in WordPerfect 6.1/ 8.0 or ASCII file format. All comments and data in electronic form must be identified by the docket control number OEI 2002 0010. Electronic comments on this document may also be filed online at many Federal Depository Libraries. B. How Should I Handle CBI Information That I Want To Submit to the Agency? All comments which contain information claimed as CBI must be clearly marked as such. Three sanitized copies of any comments containing information claimed as CBI must also be submitted and will be placed in the public record for this document. Persons submitting information on any portion of which they believe is entitled to treatment as CBI by EPA must assert a business confidentiality claim in accordance with 40 CFR part 2.203( b) for each such portion. This claim must be made at the time that the information is submitted to EPA. If a submitter does not assert a confidentiality claim at the time of submission, EPA will consider this as a waiver of any confidentiality claim and the information may be made available to the public by EPA without further notice to the submitter. VerDate 0ct< 09> 2002 15: 17 Oct 24, 2002 Jkt 200001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 25OCN1. SGM 25OCN1 65568 Federal Register / Vol. 67, No. 207 / Friday, October 25, 2002 / Notices IV. What Is the General Background for This Action? The Toxics Release Inventory ( TRI) is mandated by the Emergency Planning and Community Right­ to­ Know Act of 1986 ( EPCRA) and the Pollution Prevention Act ( PPA) of 1990. EPCRA Section 313 and PPA Section 6607 establishes requirements for Federal, State, and local governments and industry regarding reporting of toxic chemical releases and other waste management quantities. Under Section 322 of EPCRA and 40 CFR part 350, facilities submitting TRI reports may be eligible to claim Trade Secret for the specific chemical identity of the toxic chemical being reported. Pursuant to 40 CFR 350.23 (`` Disclosure to authorized representatives''), information entitled to trade secret or confidential treatment may not be disclosed by the Agency to the Agency's authorized representative until each affected submitter has been furnished notice of the contemplated disclosure by the EPA program office and has been afforded a period found reasonable by that office ( not less than five working days) to submit its comments. Such notice shall include a description of the information to be disclosed, the identity of the contractor, subcontractor, or grantee, the contract, subcontract, or grant number, if any, and the purposes to be served by the disclosure. This notice may be published in the Federal Register or may be sent to individual submitters. The Contract to manage the TRI data submissions was recompeted in 1998 and was awarded to the Computer Based Systems Incorporated, now known as Titan Systems, Inc. This contract will end January 31, 2003. The new contract will transition to Computer Sciences Corporation ( CSC) ( GSA Contract GSOOT99ALD0203) by the end of December 2002. This new facility will be located in New Carrollton, MD. All TRI submissions including trade secret and confidential information submitted pursuant to 40 CFR part 350 will be managed by CSC. In accordance with 40 CFR 350.23, EPA has determined that CSC and their subcontractors require access to trade secret and confidential information submitted under 40 CFR part 350 in order to receive, manage, process, and safely store such information. The contractor's and subcontractor's personnel will be required to sign a `` Confidentiality Agreement'' prior to being permitted access to trade secret and confidential information submitted under 40 CFR part 350. All contractor and subcontractor access to TRI trade secret and confidential information will take place at the contractor's facility in New Carrollton, MD. The contractor will have appropriate procedures and facilities in place to safeguard the TRI trade secret and confidential information to which the contractor and subcontractors have access during the term of this contract. List of Subjects Environmental protection, Trade Secret and Confidential Information, TRI Data Processing. Dated: October 21, 2002. Elaine G. Stanley, Director, Office of Information Analysis and Access. [ FR Doc. 02 27234 Filed 10 24 02; 8: 45 am] BILLING CODE 6560 50 P FEDERAL DEPOSIT INSURANCE CORPORATION Sunshine Act Meeting Pursuant to the provisions of the `` Government in the Sunshine Act'' ( 5 U. S. C. 552b), notice is hereby given that at 10: 03 a. m. on Tuesday, October 22, 2002, the Board of Directors of the Federal Deposit Insurance Corporation met in closed session to consider matters relating to the Corporation's corporate and resolution activities. In calling the meeting, the Board determined, on motion of Director James E. Gilleran ( Director, Office of Thrift Supervision), seconded by Mr. E. Wayne Rushton, acting in the place and stead of Director John D. Hawke, Jr. ( Comptroller of the Currency), concurred in by Director John M. Reich ( Appointive), that Corporation business required its consideration of the matters on less than seven days' notice to the public; that no earlier notice of the meeting was practicable; that the public interest did not require consideration of the matters in a meeting open to public observation; and that the matters could be considered in a closed meeting by authority of subsections ( c)( 2), ( c)( 4), ( c)( 6), ( c)( 8), ( c)( 9)( A)( ii), ( c)( 9)( B), and ( c)( 10) of the `` Government in the Sunshine Act'' ( 5 U. S. C. 552b( c)( 2), ( c)( 4), ( c)( 6), ( c)( 8), ( c)( 9)( A)( ii), ( c)( 9)( B), and ( c)( 10)). The meeting was held in the Board Room of the FDIC Building located at 550 17th Street, NW., Washington, DC. Dated: October 22, 2002. Federal Deposit Insurance Corporation. Valerie J. Best, Assistant Executive Secretary. [ FR Doc. 02 27325 Filed 10 23 02; 10: 30 am] BILLING CODE 6714 01 M FEDERAL HOUSING FINANCE BOARD [ No. 2002 N 12] Federal Home Loan Bank Members Selected for Community Support Review AGENCY: Federal Housing Finance Board. ACTION: Notice. SUMMARY: The Federal Housing Finance Board ( Finance Board) is announcing the Federal Home Loan Bank ( Bank) members it has selected for the 2002 03 third quarter review cycle under the Finance Board's community support requirement regulation. This notice also prescribes the deadline by which Bank members selected for review must submit Community Support Statements to the Finance Board. DATES: Bank members selected for the 2002 03 third quarter review cycle under the Finance Board's community support requirement regulation must submit completed Community Support Statements to the Finance Board on or before December 13, 2002. ADDRESSES: Bank members selected for the 2002 03 third quarter review cycle under the Finance Board's community support requirement regulation must submit completed Community Support Statements to the Finance Board either by regular mail at the Office of Supervision, Community Investment & Affordable Housing, Federal Housing Finance Board, 1777 F Street, NW., Washington, DC 20006, or by electronic mail at fitzgeralde@ fhfb. gov. FOR FURTHER INFORMATION CONTACT: Emma J. Fitzgerald, Program Analyst, Office of Supervision, Community Investment & Affordable Housing, by telephone at 202/ 408 2874, by electronic mail at fitzgeralde@ fhfb. gov, or by regular mail at the Federal Housing Finance Board, 1777 F Street, NW., Washington, DC 20006. A telecommunications device for deaf persons ( TDD) is available at 202/ 408 2579. SUPPLEMENTARY INFORMATION: I. Selection for Community Support Review Section 10( g)( 1) of the Federal Home Loan Bank Act ( Bank Act) requires the Finance Board to promulgate VerDate 0ct< 09> 2002 15: 17 Oct 24, 2002 Jkt 200001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 25OCN1. SGM 25OCN1

epa

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regulations

EPA-HQ-OIG-2002-0001-0001

Notice

Agency Information Collection Activitites; Submission of EPA ICR No. 2094.01 to OMB for Review and Approval; Comment Request, Notice.

69738 Federal Register / Vol. 67, No. 223 / Tuesday, November 19, 2002 / Notices The post­ forum meeting and drafting sessions will start at 9: 00 a. m. An agenda for these activities may be viewed on the Commission's Web site by November 27, 2002, at: http:// www. ferc. gov/ hydro/ docs/ hydro_ rule. htm. The post­ forum meeting and drafting sessions are not intended to address issues pending in individually docketed hydropower cases before the Commission. Therefore, all participants are requested to address the agenda topics and avoid discussing the merits of individual proceedings. The goal of the one­ day post­ forum meeting is for Commission staff to: ( 1) Summarize comments received at the public forums conducted throughout the country in October and November and; ( 2) discuss general issues associated with a rulemaking effort such as retention of the Traditional and/ or the Alternative Licensing Processes. The goal of the two­ day post­ forum drafting session is to provide stakeholders with an opportunity to participate in drafting concepts and language for a new integrated licensing process. All interested persons are invited to attend these activities, however, persons wishing to participate in the two­ day post­ forum drafting session will need to pre­ register. Participation in the December 11 and 12, 2002, Post­ Forum Drafting Session In addition to full group discussions at the beginning and end of each of the post­ forum drafting sessions, participants will be asked to take part in one of three drafting groups. These drafting groups include: ( 1) Early application development; ( 2) study plan development ( including dispute resolution); and ( 3) post license application filing. Therefore, those persons wishing to participate in the two­ day post­ forum drafting session will need to pre­ register by December 6, 2002, by registering on­ line at http:// www. ferc. gov/ registration. Anyone without access to the web will need to pre­ register by contacting Susan Tseng at 202 502 6065. In both preregistration procedures, participants must indicate their preference for a particular drafting group. Opportunities for Listening and Viewing the December 10, 2002, Post­ Forum Meeting Offsite and for Obtaining a Transcript The Capitol Connection offers the opportunity for remote listening and viewing of the one­ day post­ forum meeting, which is available for a fee, live over the Internet, via C­ Band Satellite. Persons interested in receiving the broadcast, or who need information on making arrangements should contact David Reininger or Julia Morelli at the Capitol Connection ( 703 993 3100) as soon as possible or visit the Capitol Connection website at http:// www. capitolconnection. gmu. edu and click on `` FERC''. The one­ day post­ forum meeting will also be transcribed. Those interested in obtaining a copy of the transcript immediately for a fee should contact Ace­ Federal Reporters, Inc. at 202 347 3700, or 1 800 336 6646. Two weeks after the post­ forum meeting, the transcript will be available for free on the Commission's FERRIS system. Anyone without access to the Commission's web site or who have questions about the post­ forum activities should contact Tim Welch at 202 502 8760, or e­ mail timothy. welch@ ferc. gov. Linwood A. Watson, Jr., Deputy Secretary. [ FR Doc. 02 29296 Filed 11 18 02; 8: 45 am] BILLING CODE 6717 01 P ENVIRONMENTAL PROTECTION AGENCY [ OIG 2002 0001; FRL 7410 4] Agency Information Collection Activities; Submission of EPA ICR No. 2094.01 to OMB for Review and Approval; Comment Request AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: Survey of Air Quality Issues After September 11, 2001 ( EPA ICR No. 2094.01) The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost. DATES: Additional comments may be submitted on or before December 19, 2002. ADDRESSES: Follow the detailed instructions in the SUPPLEMENTARY INFORMATION SECTION. FOR FURTHER INFORMATION CONTACT: Sarah Fabirkiewicz, Office of Program Evaluation, 2460T, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202 566 2717; fax number: 202 566 0837; e­ mail address: fabirkiewicz. sarah@ epa. gov. SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. EPA was granted a waiver from the 60 day public comment period for a proposed ICR. EPA has established a public docket for this ICR under Docket ID No. OIG 2002 0001, which is available for public viewing at the Office of Environmental Information Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the Office of Environmental Information Docket is ( 202) 566 1752). An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: ( 1) Submit your comments to EPA online using EDOCKET ( our preferred method), by e­ mail to: oei. docket@ epa. gov, or by mail to: EPA Docket Center, Environmental Protection Agency, Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and ( 2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. VerDate 0ct< 31> 2002 18: 11 Nov 18, 2002 Jkt 200001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 19NON1. SGM 19NON1 69739 Federal Register / Vol. 67, No. 223 / Tuesday, November 19, 2002 / Notices Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to www. epa. gov./ edocket. Title: Survey of Air Quality Issues After September 11, 2001 ( EPA ICR Number 2094.01 ). This is a request for a new collection. Abstract: The purpose of this ICR is to obtain information, through use of a public survey, about the impact of government communications regarding air quality concerns associated with the collapse of the World Trade Center towers on September 11, 2001. This ICR represents one component of a larger evaluation of EPA's response to air quality concerns associated with the collapse of the World Trade Center towers. The survey will be distributed to randomly selected individuals residing in the five boroughs of New York City. Persons residing in New York City are hereafter referred to as `` the public.'' Data generated from the questionnaire will provide information regarding the public's perception of the adequacy of the information it received about air quality, the public's interpretation of the air quality information it received, and actions taken by the public based on the air quality information received. Findings from the questionnaire in these three areas can be used to improve the way information about air quality is disseminated during times of future emergency and/ or disaster. Findings will be useful not only to EPA, but to any agency seeking to improve the effectiveness of its emergency and/ or disaster mitigation, response, and recovery activities. In some instances, it may be possible to use the data to inform future emergency and/ or disaster response techniques in other cities. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 15 minutes per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Randomly selected individuals residing in the five boroughs of New York City. Estimated Number of Respondents: 1067. Frequency of Response: Once. Estimated Total Annual Hour Burden: 266.75 hours. Estimated Total Annual Cost: $ 5,908.51 includes $ 0 annualized capital or O& M costs. Changes in the Estimates: There is no change of hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. Dated: November 12, 2002. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 02 29337 Filed 11 18 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ Petition IV 2001 8; FRL 7409 9] Clean Air Act Operating Permit Program; Petition for Objection to State Operating Permit for Monroe Power Company; Monroe ( Walton County), GA AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice of final order on petition to object to a state operating permit. SUMMARY: Pursuant to Clean Air Act section 505( b)( 2) and 40 CFR 70.8( d), the EPA Administrator signed an order, dated October 9, 2002, denying a petition to object to a state operating permit issued by the Georgia Environmental Protection Division ( EPD) to Monroe Power Company ( Monroe Power) located in Monroe, Walton County, Georgia. This order constitutes final action on the petition submitted by the Georgia Center for Law in the Public Interest ( GCLPI or Petitioner) on behalf of the Sierra Club. Pursuant to section 505( b)( 2) of the Clean Air Act ( the Act) any person may seek judicial review in the United States Court of Appeals for the appropriate circuit within 60 days of this notice under section 307 of the Act. ADDRESSES: Copies of the final order, the petition, and all pertinent information relating thereto are on file at the following location: EPA Region 4, Air, Pesticides and Toxics Management Division, 61 Forsyth Street, SW., Atlanta, Georgia 30303 8960. The final order is also available electronically at the following address: http:// www. epa. gov/ region07/ programs/ artd/ air/ title5/ petitiondb/ petitions/ monroepower_ decision2001. pdf. FOR FURTHER INFORMATION CONTACT: Art Hofmeister, Air Permits Section, EPA Region 4, at ( 404) 562 9115 or hofmeister. art@ epa. gov. SUPPLEMENTARY INFORMATION: The Act affords EPA a 45­ day period to review and, as appropriate, object to operating permits proposed by state permitting authorities under title V of the Act, 42 U. S. C. 7661 7661f. Section 505( b)( 2) of the Act and 40 CFR 70.8( d) authorize any person to petition the EPA Administrator to object to a title V operating permit within 60 days after the expiration of EPA's 45­ day review period if EPA has not objected on its own initiative. Petitions must be based only on objections to the permit that were raised with reasonable specificity during the public comment period provided by the state, unless the petitioner demonstrates that it was impracticable to raise these issues during the comment period or the grounds for the issues arose after this period. GCLPI submitted a petition on behalf of the Sierra Club to the Administrator on November 14, 2001, requesting that EPA object to a state title V operating permit issued by EPD to Monroe Power. The Petitioner maintains that the Monroe Power permit is inconsistent with the Act because of: ( 1) The inadequacy of the public participation process and related public notice; ( 2) the permit's apparent limitation of enforcement authority and credible evidence; ( 3) the inadequacy of the monitoring and reporting requirements; ( 4) the permit's exclusion of startups, shutdowns, and malfunctions; and ( 5) the incompleteness of permit itself. On October 9, 2002, the Administrator issued an order denying this petition. The order explains the reasons behind EPA's conclusion that the Petitioner has failed to demonstrate that the Monroe Power permit is not in compliance with VerDate 0ct< 31> 2002 18: 11 Nov 18, 2002 Jkt 200001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 19NON1. SGM 19NON1

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regulations

EPA-HQ-OPA-1997-0002-0069

Supporting & Related Material

RESPONSE TO COMMENTS DOCUMENT FOR THE 1997 SPILL PREVENTION, CONTROL, AND COUNTERMEASURE PLAN RULEMAKING Oil Program Center Office of Emergency and Remedial Response U. S. Environmental Protection Agency 1 Table of Contents Response to Comments Document for the 1997 Proposed Spill Prevention, Control, and Countermeasure Plan Requirements Section Page Introduction .......................................................... 2 1. Applicability ­ Oil Used Operationally ................................ 4 2. New Comments for Old Proposals................................... 8 3. Information forFutureRulemaking ................................. 13 4. Threshold Issues ­ §112.1( d)( 2)( i) and (ii) ............................ 15 5. §§ 112.2 and 112.7 Introduction ­ Alternative Plan Formats .............. 25 6. Information Submitted After Certain Discharges ­ §112.4( a) .............. 34 7. Five­ Year Plan Review and Certification ­ §112.5( b) ................... 40 8. Use of Business Records ­ §§ 112.7( e), 112.8( c)( 3)( iv), and 112.9( b)( 1) .... 46 9. Capacity of Facilities Storing Process Water/ Wastewater for Response Plan Purposes ­ proposed §112.20( f)( 4) ............................ 54 10. Facility Response Plan Format ­ §112.20( h) .......................... 55 11. Supporting Analyses ............................................ 57 12. Miscellaneous Comments ........................................ 61 2 INTRODUCTION Purpose of this Document The purpose of this document is to respond to comments received on the 1997 proposed rule (62 FR 63812, December 2, 1997) to revise the Oil Pollution Prevention and Response rule, also known as the Spill Prevention, Control, and Countermeasure (SPCC) rule (40 CFR part 112), promulgated under the Clean Water Act. The proposed revisions are in addition to revisions previously proposed to part 112 in 1991 and 1993. We proposed the 1997 revisions primarily to reduce the information collection burden of the SPCC Plan requirements. Background of this Rulemaking Part 112 of 40 CFR outlines requirements for both prevention of and response to oil spills. The prevention aspect of the rule requires the preparation and implementation of SPCC plans. This rulemaking affects mainly SPCC requirements. Response requirements are largely unchanged at this time, except for a proposal that clarifies acceptability of alternative response plan formats. The SPCC requirements were originally promulgated on December 11, 1973 (38 FR 34164) under the authority of section 311( j)( 1)( C) of the Clean Water Act (CWA or the Act). Regulated facilities are also limited to those that, because of their location could reasonably be expected to discharge oil in quantities that may be harmful into the navigable waters of the United States or adjoining shorelines, or that affect certain natural resources. The SPCC requirements have been amended a number of times. On October 22, 1991, the Agency proposed certain changes to 40 CFR 112.7. The October 1991 proposed revisions involved changes in the applicability of the regulation and the required procedures for the completion of SPCC plans, as well as the addition of a facility provision. The proposed rule also reflected changes in the jurisdiction of section 311 of the Act made by amendments to the Act in 1977 and 1978. Those proposed revisions, as modified, are finalized in this rule. On February 17, 1993, the Agency again proposed clarifications of and technical changes to the SPCC rule, and facility response requirements to implement OPA. 58 FR 8824. The proposed changes to the SPCC prevention requirements included clarifications of certain requirements, contingency plans for facilities without secondary containment, prevention training, and methods of determining whether a tank would be subject to brittle fracture. The facility response plan requirements of the 1993 proposal were promulgated on July 1, 1994 (59 FR 47384) and codified at 40 CFR 112.20­ 21. The prevention requirements, as modified, are finalized in this rule. 3 In 1996, we concluded a survey of SPCC facilities. We used the results of that survey to develop the December 2, 1997 proposed rule (62 FR 63812). The survey results are part of the administrative record for this rulemaking. The purpose of the 1997 proposal was to reduce the information collection burden now imposed by the prevention requirements in the SPCC rule without creating an adverse impact on public health or the environment. We also proposed changes in information collection requirements for facility response plans, but withdraw them in this rulemaking. The 1997 SPCC proposals, as modified, are finalized in this rule. Organization of this Comment Response Document To develop this document, we first carefully reviewed the letters received by the public docket and identified relevant issues raised by the commenters based on the content of the proposed rule. We then grouped the issues according to categories and subcategories. We address the major points made in the comments and respond to them. We include several comment excerpts and responses pertaining to each issue. In most cases, we do not include comment excerpts that simply state support for our proposed revisions. Instead, we list the letter number of each general supporting comment in the Comments section for each category. The letter numbers were assigned to each letter in accordance with when the letter was received by the public docket. The comment excerpts that are included in this document are taken verbatim from the comment letters received by the public docket. In some cases, multiple commenters submitted the same comment. We indicate this by including the multiple commenter numbers with the excerpt. We group the comments that make similar statements and provide one response for the group. We respond to the remaining comments individually. 4 1. Applicability ­ Oil Used Operationally Background: In the 1991 preamble, we addressed the fact that certain facilities may have equipment, such as electrical transformers, that contain significant quantities of oil for operational purposes rather than for storage. We stated that such oil­ filled equipment is not be subject to the bulk storage container provisions in proposed §112.8( c) and §112.9( c) because the primary purpose of this equipment is not the storage of oil in bulk. However, we also stated that oil­ filled equipment must meet other applicable SPCC requirements, including the general requirements of §112.7. We also indicated that the oil storage capacity of the equipment must be included in calculating the total oil storage capacity of the facility to determine whether the facility is subject to the SPCC rule. In 1991, we also asked commenters to identify possible operational uses of oil, other than electrical transformers, that may not currently use secondary containment as a common industry practice, and that should not be subject to bulk storage provisions. Comments: Integrity testing. It is inappropriate to require facilities to integrity test electrical devices. (18, 65) Because "... electrical devices are drained, opened (and in some cases, physically entered) and inspected during scheduled preventative maintenance. The purpose of this inspection is to ensure that the internal electrical components deliver the required efficiencies in voltage/ amperage conversion or circuit protection. When the dielectric fluid is replaced in the device, it is processed using a vacuum and filter press procedure to ensure that all entrained moisture is removed from the oil. This enhances the dielectric properties of the oil and removes any traces of water that could become reactive when the device is energized. An additional benefit of this process is to virtually eliminate the potential for moisture­ induced corrosion of the interior of the device. Oil samples are collected from substation equipment at specified time intervals and evaluated for moisture and dissolved gas content." (18) "Integrity testing for electrical equipment should not be required because there is no established integrity test that is appropriate for such equipment. Moreover, performing an integrity test would require taking the equipment out of service, which could create a disruption in the supply of electricity. In addition, integrity testing of electrical equipment serves no useful purpose. Unlike tanks, where regular filling and emptying can mask the presence of a leak, dielectric fluid is rarely added to electrical equipment. Therefore, any leak would soon manifest itself as a drop in the level of dielectric fluid in the unit. Finally, integrity testing would serve little purpose because the use of electrical equipment is equivalent to continuous integrity testing; a leak will lead to equipment failure. Because any significant loss of fluid interrupts the flow of electricity, any significant fluid loss is detected quickly." (65) Response plans ­ electrical equipment. "There is also no reason to apply all of the requirements of an OPA response plan to electrical equipment when secondary containment is impractical for Facilities subject to the SPCC program. The OPA 5 regulations are designed to apply to Facilities containing millions of gallons of oil, and it makes little sense to apply these requirements to facilities orders of magnitude smaller. Preparation of an OPA plan is a detailed and costly endeavor requiring the determination of a worst case discharge, a hazard and vulnerability analysis, tiered planning scenarios, and compliance with complicated requirements regarding the location and testing of response equipment, response times and personnel qualification and training. Last, the OPA rules require that covered facilities must have response equipment under contract for a worst case discharge. Because the number of certified response organizations is small, having one on retainer can be extremely costly. These measures are simply not appropriate for electrical distribution systems, which do not pose the same risk as oil transfer and storage facilities and which are already being adequately addressed by the utilities' current response plans." (65) Risk­ based approach to applicability. "NMPC currently addresses such facilities on a risk­ prioritized basis such that those deemed to have a high risk of discharging oil to navigable waters have a specific SPCC plan, but those deemed to have medium or low risk are addressed more generically. The majority of substations are considered to be of medium to low risk. " (19) "The equipment containing significant oil can be inspected for its adjacency to traffic. If the risk of vehicular impact is high, traffic barriers can be constructed to prevent collisions. This process will vastly reduce the most common cause of a release. During the above inspections, a determination can be made to decide if some equipment should be protected with secondary containment. Also during the inspections, the equipment can be checked for any areas of concern. Should a problem be identified, measures can be taken to mitigate the problem. A general spill prevention response procedure can be written for distribution equipment, and­ corresponding training be given, so employees can take measures to prevent spills and can respond appropriately to a spill. (Note: SPCC training is already given to these employees for substation equipment.) Also note that distribution equipment is currently labeled with an emergency call number should a passerby note anything peculiar." (32) Secondary containment ­ impracticability. "( T) he demonstration of this impracticability is primarily based upon the fire pool hazard that would be created by containing oil at the base of an electrical device, and the electrical hazard created by pooling rainwater around an energized device. However, another consideration is the access restrictions to essential equipment that would be imposed by the installation of spill containment structures. The overhead work clearances at the majority of substations are severely restricted due to the low electrical busses that conduct current to and from the electrical devices. Therefore, the larger substation equipment is mounted on sledge runners to enable the device to be skidded under the overhead bus if necessary. Installation of a containment basin around a device would require that the device be lifted clear of the basin wall prior to removal or installation. This would pose an electrical safety hazard to the individual operating the crane, as well other individuals in the vicinity." We 6 should allow facilities to substitute absorbent in lieu of secondary containment or spill diversionary structures. (18) "Because electrical equipment is electrified, water must be able to drain away from the equipment to avoid shock and fire hazards. This makes secondary containment impracticable at many electrical equipment locations. " (65) State rules. "AST's containing mineral oil are exempt under Colorado AST regulations." (32) "The State (Michigan) recognizes the distinction between the use of operating fluid in electrical equipment and the storage of oil in tanks or other containers. EPA should likewise exclude this equipment from inclusion into the SPCC regulations based on the industry
s excellent safety record and the fact that the use of dielectric fluid in electrical equipment does not constitute "storage" or "consumption" of oil." (76) Use of oil. We lack jurisdiction to regulate the operational use of oil, especially in electrical transformers, substations, and other equipment. The regulation is meant to apply only to facilities that have the potential to cause catastrophic harm to the environment in the event of an oil spill, which would not include any spill event resulting from oil used in electrical equipment. (18,19, 20, 31, 32, 35, 57, 60, 65, 69, 70, 76, L1) Response: Integrity testing. We have distinguished the bulk storage of oil from the operational use of oil. We define "bulk storage container" in the final rule to mean any container used to store oil. The storage of oil may be prior to use, while being used, or prior to further distribution in commerce. For clarity, we have specifically excluded oilfilled electrical, operating, or manufacturing equipment from the definition. In both §§ 112.7( d) and 112.8( c)( 6), integrity testing requirements apply only to bulk storage containers. Therefore, oil­ filled electrical, operating, or manufacturing equipment is not subject to the integrity testing requirement. Response plans ­ electrical equipment. We agree with the commenter that most SPCC facilities should not have to prepare response plans nor should electrical facilities be subject to the requirements for bulk storage facilities. Section 112.7( d) of the final rule does not require preparation of a facility response plan when a facility lacks secondary containment. A contingency plan following the provisions of 40 CFR part 109 and compliance with the other provisions of §112.7( d) is sufficient. Risk­ based approach to applicability. A facility with oil­ filled equipment might reasonably be expected to discharge oil as described in §112.1( b). Therefore, the prevention of discharges from such facility falls within the scope of the statute. The discharge prevention measures employed at such a facility will be dictated by good engineering practice. Secondary containment ­ impracticability. Facilities that use oil operationally include electrical substations, facilities containing electrical transformers, and certain hydraulic 7 or manufacturing equipment. The requirements for bulk storage containers may not always apply to these facilities since the primary purpose of this equipment is not the storage of oil in bulk. Facilities with equipment containing oil for ancillary purposes are not required to provide the secondary containment required for bulk storage facilities (§ 112.8( c)) nor for onshore production facilities (§ 112.9( c)) for this equipment, nor implement the other provisions of §112.8( c) or §112.9( c). Oil­ filled equipment must meet other SPCC requirements, for example, the general requirements and the requirements of §112.7, including §112.7( c), to provide appropriate containment and/ or diversionary structures to prevent discharged oil from reaching a navigable watercourse. The general requirement for secondary containment, which can be provided by various means including drainage systems, spill diversion ponds, etc., will provide for safety and also the needs of section 311( j)( 1)( C) of the CWA. State rules. State laws may have different applicability standards than the SPCC rule. Dielectric fluid (along with any other oil based fluid found in electrical equipment) is regulated under the SPCC program based on the SPCC definition of oil, which includes oil of any kind or in any form. Our rule includes the "use" and "consumption" of oil as a basis for applicability. Use of oil. We disagree that operational equipment is not subject to the SPCC rule. We have amended §112.1( b) to clarify that using oil, for example operationally, may subject a facility to SPCC jurisdiction as long as the other applicability criteria apply, for example, oil storage capacity, or location. Such a facility might reasonably be expected to discharge oil as described in §112.1( b). Therefore, the prevention of discharges from such facility falls within the scope of the statute. In addition, a facility may deviate from any inapplicable or inappropriate SPCC requirements, or from most applicable requirements, if the owner or operator explains his reasons for nonconformance and provides equivalent environmental protection by some other means. See §112.7( a)( 2). See also §112.7( d). 8 2. New Comments for Old Proposals Background: In the 1997 proposal, we stated that we would finalize the 1991 and 1993 proposals without seeking additional comments on those proposals. Comments: Support for additional comments or reproposal. (6, 7, 11, 17, 24, 26, 37, 41, 49, 50, 52, 58, 61, 70, 74, 77). Burden. The 1991 proposal "... would increase the burdens on small tank batteries and other facilities ­ arguably, to a greater degree than the current proposal reduces the burdens. At this point, the Agency might consider republishing the whole spill prevention rule so that the public can view the proposed changes in a comprehensive manner." (64) Industry standards. "...( M) uch has changed since the 1991 proposal was issued. Many API standards and recommended practices applicable to aboveground storage tank operation have been revised since that time. These revisions have further strengthen the industry's goal of environmental protection." (37) "Standards, specifications, and recommended practices for aboveground tank operations, terminals, and exploration and production tank operations have been revised and updated by the American Petroleum Institute. Because of the time that has elapsed, the changes in operational procedures of the oil and gas industry which have improved the degree of environmental protection, and the new information EPA obtained from their tank survey, RMOGA urges EPA to re­ publish the spill prevention rule 40 CFR 112 in its entirety incorporating all proposed changes as a draft for comment." (49) We should repropose the changes because of the following industry standards that have been developed since the 1991 proposal: Std 620, Design and Construction of Large, Welded, Low­ Pressure Storage Tanks, 9th, ed, 1996; Std 650, Welded Steel Tanks for Oil Storage, 9th ed, 1993; Std 653, Tank Inspection, Repair, Alteration, and Reconstruction, 2nd ed, 1995; Std 2000, Venting Atmospheric and Low­ Pressure Storage Tanks; Nonrefrigerated and Refrigerated, 4th ed, 1992; Std 2015, Safe Entry and Cleaning of Petroleum Storage Tanks, 5th ed, 1994; and, Recommended Practice 2350, Overfill Protection for Petroleum Storage Tanks, 2nd ed, 1996; In addition, API Standard 2610, Design, Construction, Operation, Maintenance and Inspection of Terminal and Tank Facilities, first published in 1994, provides a comprehensive guide to the best industry practices for terminal design, construction, inspection, maintenance, repair, and environmental protection. Similarly, specifications and recommended practices for exploration and production tanks have been revised during the six­ year period, including: Spec. 12B, Specification for Bolted Tanks for Storage of Production Liquids, 14th ed, 1995; Spec. 12D, Specification for Field Welded Tanks for Storage of Production Liquids, 10th ed, 1994; Spec. 9 12F, Specification for Shop Welded Tanks for Storage of Production Liquids, 11th ed, 1994; Spec. 12P, Specification for Fiberglass Reinforced Plastic Tanks, 2nd ed, 1995; and, Recommended Practice 12R1, Recommended Practice for Setting, Maintenance, Inspection, Operation and Repair of Tanks in Production Service, 5th ed, 1997." (58) More recent events. Hopes that EPA "... considers the oil and gas industry and standard industry operating practices have changed significantly since 1913 and that a prescriptive regulation is not necessary. (6) 1995 Survey, Liner Study, Cooperative Program. Commenters felt that additional comments should be allowed on the 1991 and 1993 proposals before finalization because of changes and developments in our policy and information since the time of proposal. (17, 24, 26, 41, 50, 58, 61, 77) These events include "... over six years of additional [EPA] experience with the basic SPCC program, new studies (e. g. EPA's 1996 "Liner Study" report to Congress), revisions and additions to applicable industry initiatives and standards (e. g. API's Standard 653 and Recommended Practice 2350), and significant maturing of the Facility Response Plan Program." (24, 50) "The 1997 proposed rules indicate that significant information was obtained from a recently completed industry SPCC survey. This information should be presented to industry if it includes justification for the previously proposed rule revisions." (77) "The EPA should republish those provisions from the 1991 proposal it plans to adopt along with its conclusions from the 1995 survey and allow the affected industry sectors to evaluate those conclusions. For example, the survey results appear to suggest that the current SPCC plan program is effective in reducing spills, spill volumes, and offsite migration of oil. MEDC doubts that such results support adding high­ cost burdens to lowrisk operations. MEDC is also concerned that the survey understates the number of small exploration and production facilities, a factor which could distort economic analysis of the effect of a rule." (17) "... EPA owes the parties potentially affected by adoption of the 1991 proposals the chance to review the survey results along with any analysis EPA has performed of those results to justify rules from the 1991 proposal." This is important because the current proposal provides regulatory relief to large facilities and not the more numerous smaller facilities, which the survey may have mischaracterized. (26) Personnel changes. Objects to our plan to finalize the 1991 and 1993 SPCC plan rule proposals without additional comment because of industry personnel changes and new personnel, new companies, changes in spill prevention 10 standards, equipment, practices and procedures, and the need to plan, budget and arrange for the financing of compliance. Identifies two significant developments since the 1991 and 1993 proposals: "A. New companies have entered the industry since 1993 and 1991. Since a significant number of facilities affected by these rules may not have been in existence at the time they were released, they should not be subjected to the imposition of costly new requirements without the opportunity for notice and comment. B. There have been significant personnel changes in industry positions responsible for facility spill prevention operations. Industry representatives began working with EPA on the proposed SPCC Plan revised regulations in 1987. Since that time, most of the industry personnel involved in that effort, or in reviewing drafts for their companies, have retired or moved to other positions. There have been tremendous reductions in company personnel throughout the industry. (Note: Since 1984, more than 475,000 persons have left their employment in the petroleum industry.)" New personnel at petroleum facilities need the opportunity to review and understand the proposed 1991 and 1993 regulations and evaluate their impact, financial and otherwise, on the companies they work for, on the operations for which they have responsibility, and on the budgets they must obtain to comply. (52) Regulatory changes. We should solicit additional comments before finalizing the proposals because of changes in regulatory and statutory issues since 1991 and 1993. (17, 26, 41, 50, 58, 61, 77) FRP rule. Some commenters believed that the implementation of the Facility Response Plan (FRP) rule alone requires us to solicit additional comments concerning the SPCC proposals. "The current regulatory reduction proposals acknowledge the relationship between SPCC plans and FRPs. MEDC believes that in writing and implementing FRPs many large, high­ risk facilities have made improvements in their spill prevention and control plans. The FRP program has changed materially the oil spill risk posed by oil storage tanks and its impact should be taken into account." (17) We should acknowledge developments in compliance provisions since 1991 before promulgating the new SPCC rules. (26, 77) "Since 1991 EPA has proposed and adopted rules identifying higher­ risk facilities and requiring them to develop and implement FRPs under the Oil Pollution Act of 1990. The current proposal recognizes the close 11 relationship between SPCC plans and FRPs by allowing facility operators to use one plan for both, either an integrated contingency plan or an equivalent state plan. IPAA believes that in writing and implementing FRPs, many operators of large, high­ risk facilities have had to implement improvements in spill prevention and control. Those facility changes require EPA to reconsider the basis for its 1991 SPCC plan proposals because the universe of regulated facilities has changed significantly." (26) Because of the Oil Pollution Act amendments and significant maturing of the Facility Response Plan program, review and comment are needed before the promulgation of the 1991 and 1993 proposals. (41, 50, 58) Requirements from the FRP program and planned regulations under the SPCC proposal are redundant, may be unnecessary and need further evaluation. (41, 58) "The current proposal, allowing integrated contingency plans (ICPs) or other state plans, acknowledges the close relationship between the SPCC plan and FRP programs. Even though one program addresses spill prevention and the other addresses spill response, the facility analysis for the FRP also serves the needs of spill prevention by identifying risks. We believe that the process of implementing FRPs at the highest risk facilities has, as part of the process, also helped improve spill prevention efforts." (58) Response plan requirement. Promulgation of the 1991 and 1993 proposals may require small facilities to adopt OPA response plans. "Before imposing such requirements on the industry, it would be appropriate to determine what number of releases to navigable water take place as a result of a lack of response planning at small, non­ OPA facilities that may have a SPCC plan with secondary containment in place but not the appropriate spill response equipment or trained personnel." (6) Time lapse. Other Agency events necessitate additional public comments. (41, 58, 61) "The significant time lapse since (the 1991 and 1993) proposals ­­ along with amendments to the Oil Pollution Act and EPA's recommendation to Congress in 1996 to establish the Oil Cooperative Program ­­ strongly suggested that EPA had abandoned its intent to finalize the 1991 and 1993 proposals. We believe that actions (EPA's intent to establish an Oil Cooperative Program; the data collected by EPA's facility survey; changes made to regulatory requirements; and revisions to industry standards) taken since these proposals mandate that EPA review the need for additional changes to the program. We strongly recommend that EPA not finalize the earlier proposals without first allowing further review and comment, especially since many of the proposed changes may no longer be necessary." (58) "...( T) he passage of time and intervening events, in particular, the President's directive on burden reduction and the Agency's own 1995 SPCC Survey." (70) 12 Response: Additional comments or reproposal. It is not necessary to repropose the 1991 and 1993 proposals because of mere passage of time. We received numerous comments on every side of most issues. In developing this final rule, we have considered changes that have taken place in the oil industry, industry standards, and regulations that may affect the SPCC rule. We have also considered changes in the various industries which comprise the universe of SPCC facilities which have occurred since our original proposals. We encourage the use of industry standards to implement the rule, without incorporating any particular standard into the rule, thereby averting possible obsolescence of those standards. We used the results of our 1995 SPCC facility survey to develop our 1997 proposed rule. These results are also part of the administrative record for this rulemaking. We have also considered and responded to all of the comments received in 1991 and 1993 in their respective Comment Response Documents or in the preamble to today's final rule. The Oil Cooperative Program does not affect the substantive provisions of the rule, but merely encourages facilities to go beyond the rule in effecting environmental enhancements. FRP rule. Only a small subset of facilities regulated under the SPCC program, i. e., approximately 6, 000 facilities, are also subject to FRP requirements. Recognizing the impact of FRPs, we have exempted those facilities from some of the requirements of the SPCC rule, for example, information on emergency procedures (§ 112.7( a)( 4) and (5)). We also recognize the impact of other rules, for example State rules, the Federal rules governing solid waste (i. e., the RCRA rules), and rules governing permitted discharges into waters of the United States (National Pollutant Discharge Elimination System or NPDES). We permit facilities to use as SPCC Plans, in whole or in part, plans that were drafted to satisfy the requirements of these and other authorities. Those plans must meet all Federal requirements or be supplemented so that they do, and crossreferenced to the applicable Federal requirement. As a result, we do not believe it is necessary to repropose the 1991 and 1993 SPCC proposals for additional public comment regarding recent regulatory issues. Personnel changes. In developing this final rule, as noted above, we have considered changes that have taken place in the oil industry, industry standards, and regulations that may affect the SPCC rule. For the past 26 years, owners and operators of regulated facilities have been responsible for training their personnel in applicable regulations, such as 40 CFR part 112. Such responsibility is in effect now, and will continue under the revised rule. New companies and new personnel of those companies are on notice as to applicable rules and proposals. They have also had the 13 opportunity to comment on the 1997 proposal. Furthermore, we have considered cost implications for all three proposals which we are finalizing today. Response plan requirements. We have no plans to require SPCC facilities for which secondary containment is not practicable to develop response plans. Therefore we have withdrawn §112.7( d) as proposed in 1993. Only a contingency plan following the provisions of 40 CFR part 109 and compliance with other provisions of §112.7( d) is necessary when secondary containment is impracticable. Only onshore facilities that meet the criteria of substantial harm and/ or significant and substantial harm facilities need to comply with the FRP requirements in 40 CFR 112.20­ 21. 3. Information for Future Rulemaking Background: In our 1997 proposal, we requested comments on new standards, technologies, or approaches that have been developed since the enactment of OPA which would reduce the burden of other SPCC rule requirements, without compromising environmental protection. We requested these comments in order to discover additional ways to reduce the information collection burden of the rule. In addition, we requested comments on measures not required by the SPCC rule that would enhance the environmental protection that the rule provides. Our purpose for requesting these comments was to secure information for developing possible future rules or policies, not developing this final rule. Comments: Cathodic protection. Cathodic protection should be required for all new steel tank bottoms and piping in contact with the soil or other backfill material. (39) Double­ walled or vaulted tanks. Technological improvements in AST design standards, particularly in the standards for smaller ASTs, have greatly reduced or totally eliminated the potential for environmental contamination the SPCC requirements were designed to address. Technological advancements include concrete encased doubled– walled tanks, secondary containment, overfill and spill prevention devices, flow restriction and fuel shut­ off equipment, Early Warning Fire Detection equipment, and interstitial monitoring. (36) Integrity testing ­ robotic inspection. We should amend the rule to require that all aboveground bulk oil storage tanks should be subject to periodic integrity inspection and testing at a minimum of once every five years and should use such techniques as internal in­ service robotic inspection of tank bottoms. (54) Secondary containment. "Given that API Bulletin 16D has been implemented throughout the oil and gas industry since 1974 and the vast majority of oil and gas production facilities ... are protected by diking or secondary containment it is 14 unnecessary for EPA to propose such far reaching and extremely expensive administrative requirements." (6) Tank manufacturers. The involvement of the Underwriters Laboratories, Inc (UL) and Underwriters Laboratories of Canada (ULC) would appear to be logical inclusions in the objectives of implementing the entire OPA objectives. "A specific example of a proposed requirement that would immediately enhance the environmental protection the SPCC rule provides without generating any Agency burden would be to stipulate that every tank manufacturer is required to notify existing and prospective end­ users of the need to comply with the program. This can easily be done via the point­ of­ sale invoice generated by the tank manufacturer which can be submitted to the Agency as a source document for auditing purposes." (73) Response: We appreciate these comments and will consider them for future rulemaking. Today's final rule encourages facilities to use industry practices, standards, and procedures. We also encourage the use of innovative technology that meets rule requirements. Cathodic protection. Cathodic protection or coatings is already required for all new completely buried steel tank bottoms (§ 112.8( c) 4)). New or replaced buried piping installations must also be protected with a protective wrapping and coating (§ 112.8( d)( 1)). Tank manufacturers. While we believe it may be desirable for tank manufacturers to advise purchasers of their equipment of the need to comply with SPCC rules, it is the responsibility of the facility owner or operator to comply, whether the manufacturer notifies him or not. As noted above, such a requirement would increase the information collection burden of the rule. 15 4. Threshold Issues ­ §112.1( d)( 2)( i) and (ii) Background: In 1997, we asked for comments as to whether any change in the level of storage capacity which subjects a facility to this rule is justified. We noted that we were considering eliminating the provision that requires a facility having a container with a storage capacity in excess of 660 gallons to prepare a Plan, as long as the total capacity of the facility remained at 1, 320 gallons or less. The effect of such a change would be to raise the threshold for regulation to an aggregate aboveground storage capacity greater than 1,320 gallons. We did not at that time suggest or propose any underground storage tank threshold change. Comments: Support for current threshold. The revision would "... reduce the burden of reporting for facilities storing as few as 25 55­ gallon drums and not increase risks to the environment. It is our understanding that the intent of the volume restrictions is based on what volume would cause a "significant" environmental impact. It is highly improbable that numerous individual 55­ gallon drums (or similar capacity containers) would fail simultaneously causing a significant environmental impact. " (41, 47, 61, 77) Support for proposal. Clarity and consistency. The change would create consistency in the rule by applying one standard of applicability (i. e. total capacity). (14) It would clarify the requirements of the rule. (30) Cost. Supports elimination of the 660 gallon provision due to the relatively high cost to prepare and implement a Plan as well as the relatively small risk posed by such containers. The 660 gallon provision is a burden on small businesses that must design an SPCC plan for their storage tanks. (2, 5, 6, 7, 9, 10, 13, 15, 28, 29, 30, 32, 36, 38, 42, 43, 45, 46, 48, 49, 53, 58, 64, 66, 71, 74, 75, L2 ) Farms. "...( T) he proposed increase in storage capacity for a single container size to 1320 gallons from 660 gallons is a move in the right direction for our member cooperatives and their patrons. We feel that in most if not all cases that this increase in the size of tanks will have no negative effect on the safety of the environment." (71) Fewer measures necessary. Supports a higher threshold because "... oil spills from containers of less than 660 gallons can generally be controlled with less extensive spill prevention procedures, methods, and equipment than are required under 40 CFR part 112." (46) Less environmental risk. "...( T) he costs of preparing extensive SPCC Plans (including the cost of hiring a registered professional engineer) may at times be 16 an unnecessary burden for such facilities, given the quantities of oil actually stored. HC& S believes that the requirement to maintain an SPCC Plan should be based on the environmental risk posed by the facility rather than being strictly based upon the total storage capacity available." (46) "The $2500 average cost to US WEST for a single SPCC plan far outweighs the true risk to the environment since the likelihood of a spill is so improbable." Outlines the various safety devices equipped on such tanks, declaring that these devices provide excellent spill prevention. (48) The present 660 gallon criterion promotes the installation of tanks smaller than 660 gallons. This results in increased deliveries to keep the tanks filled, which therefore increases the probability of spills associated with delivery and filling events. (59) "( T) he current provision discourages pollution prevention and efficient material management. EPA pollution prevention guidance recommends the use of larger containers to reduce waste generation and reduce possibility of stormwater contamination from possible spills and leaks. This will also benefit used oil recycling by encouraging the use of larger containers for accumulation storage, by not having to worry about being required to prepare a written SPCC Plan." (L4) Other programs. The proposed rule change would not result in a decrease in environmental protection because of other existing oil spill prevention programs or plans. (29, 32, 79, 83, L1) Hazardous material disclosure. The proposed change is justifiable due to local hazardous material disclosure laws that require facilities with certain thresholds of chemicals to prepare a Plan that includes an emergency response procedure. (L1) NPDES. "( W) ith the national storm water program fully in place and actively being implemented by either EPA or the states, oil­ containing tanks are now generally subject to storm water pollution prevention best management practices designed to prevent releases to storm water and the environment." (83) Reduced duplication. The rule change would reduce "duplication with other federal and local regulations aimed at preventing and preparing for a release or spill of oil." (L1) Small business. "We believe a number of small businesses, both petroleum marketers and non­ marketers, would benefit from the proposal and be given reasonable regulatory relief. For example, there are countless numbers of small, temporary storage tanks at construction sites which are there for a short duration of time that, we believe, should not be required to carry out a SPCC Plan." (78) 17 Technological improvements. "...( T) echnological improvements in aboveground storage tank (AST) design standards and the mandates of state/ county fire codes and state or local environmental agencies already provide sufficient spill prevention and control for small ASTs. (36) "...( T) echnological improvements in AST design standards, particularly for smaller ASTs, have outpaced the SPCC plan requirement and caused it to become superfluous. The majority of technological improvements in AST system design over the past twenty­ five years have been prompted by fire safety interests, and include secondary containment, overfill spill­ prevention equipment, insulation, inventory control, and release detection equipment. These improvements, although aimed at preventing the spread of fire by containing any released oil, have the dual benefit of preventing spills or releases and subsequent environmental contamination. Whereas in the past ASTs equipped with these improvements were not commonly available, today ASTs smaller than 1,300 gallons are being manufactured with these technological improvements. In addition, smaller ASTs are `shop built' or factory fabricated rather than field­ erected, resulting in an increased quality of construction and a reduced likelihood of tank failure." (75) Alternative threshold suggestions. 2,001 gallons. "...( T) he total capacity threshold of 1, 320 gallons should be increased. Many agricultural retailers operate with two 1,000­ gallon tanks. However, these tanks are only in use for that part of the year in season. If the agency is serious about providing relief to small businesses, it would also provide agricultural service and input providers ­­ as well as farmers themselves ­­ a total capacity threshold of 2001 gallons." (53) 2,500 gallons. "With the increasing size of farm equipment, larger tank sizes are necessary for efficiencies and we concur with the need for increased tank size. We would propose that this upper limit be increased to 2500 gallons. Larger tanks would require less frequent fueling and handling, and could actually be safer by reducing the number of times a tank needs to be filled." (71) 10,000 gallons. "...( E) xclude all facilities where individual oil­ containing units have a capacity of 10,000 gallons or less. This is based on the Agency's own survey of facilities potentially subject to the SPCC regulations (" Analysis of the Relationship Between Facility Characteristics and Oil Spill Risk"), and the electric utility industry's record of infrequent discharges of dielectric fluid to navigable waters. EPA's survey categorizes facilities storing less than 10, 000 gallons of oil as `small'. The summary of the regression analysis in Exhibit 2 begins at 10,000 gallons implying that those units are not of regulatory concern. The annual number of discharges to navigable waters from the oil storage 18 facilities exceeds by orders of magnitude the extremely low number of comparable discharges from electrical equipment. These data are a clear indication that "small" capacity tanks and containers (10,000 gallons and less) do not pose a risk that justifies regulation and inclusion within the SPCC program." (70, 76) Electrical equipment. 15,000 gallons. (27, 31, 35, 69, 70) "...( T) he number of spills from electrical equipment is negligible. Furthermore, spills that have occurred from this equipment are not a significant threat to the environment. In addition, electrical equipment sites typically have a gravel pit, which help absorb and contain any spill that may occur. In general, electrical equipment tanks and containers of this nature do not pose significant risks to the environment sufficient to warrant being included in the SPCC program." (27) "Oil­ filled equipment has stringent construction requirements resulting in very low spill rates. EPA recognized the insignificance of this equipment in its survey of Characteristics and Oil Spill Risk" (1996, p. 1). The Agency concluded `that facilities with larger storage capacity are likely to have a greater number of oil spills, larger volumes of oil spilled, and greater cleanup costs. '" (35) EPA should "... adopt a general tank threshold of 10,000 gallons (for non­ electrical equipment) and a single unit threshold of 15,000 gallons for electrical equipment. Considerable EPA data supports this change. EPA has concluded from the survey data "that facilities with larger storage capacity are likely to have a greater number of oil spills, larger volumes of oil spilled, and greater cleanup costs." (65) Lower threshold. 110 gallons. "DOT consistency dictates setting the threshold capacity at 110 gallons i. e., 2­ 55 gallon drums. This change would bring EPA into consistency with DOT. Additionally, E& P facilities include small containers e. g., 110 gallons when the plan threshold is attained. Further, as indicated in 40 CFR part 110, oil spills even causing a sheen are devastating. Thus, sheens from home heating oil tanks are every bit as important as sheens from crude oil tanks. We recommend reducing the threshold of applicability to 110 gallons of oil." (8) 250 gallons. "The current thresholds should remain and the only alteration should be the modification of the "navigable waterway to be inclusive rather than exclusive; therefore, the new rule would state: "a facility with a single container of 250 gallons (rather than 660 gallons), an 19 aggregate of 1, 320 gallons OR is considered potentially harmful to the navigable OR ground/ drinking water resources as determined by the appropriate authority, must prepare and implement a certified SPCC Plan." (73) No aggregate threshold, container threshold only. The threshold should be "changed from a facility basis to a tank basis and that the threshold be set at 660 gallons per tank. ... First, determination of SPCC plan applicability is simpler if a per­ tank limit is established, as the need to calculate an aggregate oil volume is eliminated. This makes applicability of the rule easier to understand and is particularly important for smaller facilities. Secondly, small tanks pose less risk to the environment because of their limited volume. Experience demonstrates that it is highly unlikely that multiple tanks will fail simultaneously. Therefore, we believe this threshold change would not reduce the effectiveness of the SPCC plans." (41, 47, 61) Completely buried tanks ­ 63,000­ gallon threshold. "Many service stations exceed this capacity, as they commonly store three grades of gasoline in underground storage tanks (USTs) of 15,000 gallons each. A separate regulatory program for USTs, established by the Resource Conservation and Recovery Act (RCRA) Subtitle I and fully implemented as of December 1998, makes application of the SPCC rule unnecessary. Additionally, we believe that the SPCC requirements were not intended to address service stations. Thus, increasing the threshold to approximately 63,000 gallons or 1,500 barrels would be appropriate." (41) Exemption ­ electrical equipment. OPA rules are "designed to apply to facilities containing millions of gallons of oil, and it make little sense to apply these requirements to facilities orders of magnitude smaller." (31) Urges a complete exclusion of electrical equipment from the SPCC program. (69) Minimum container size. De minimis container sizes should exist and these containers should be excluded from calculating aggregate on­ site storage capacity. Suggestions for a minimum container size ranged from 55 gallons to 25,000 gallons. The majority of these commenters favored either a greater than 55 gallon or greater than 660 gallon threshold. (38, 41, 47, 51, 58, 61, 77) Less than 55 gallons. We should establish a de minimis volume that would allow containers with a storage capacity of less than 55 gallons to be exempted from the calculation of total facility storage capacity. "...( T) his would eliminate the burden of quantifying oil and oil mixtures in small containers such as pails and carboys. In addition, guidance should be provided with regard to which oilcontaining machines and systems within facilities are to be counted in 20 calculating total facility storage capacity. A de minimis threshold should be considered in this case as well." (51) 660 gallons. Aggregate storage capacity determinations for SPCC plan requirements should not exist and any container below 660 gallons should be considered de minimis. "Containerization is a key factor in limiting spills and that individual container size rather than the aggregate size of all oil containers is an appropriate indicator of spill potential. Small containers, such as those less than 660 gallons, pose less environmental risk than large containers in the event of a discharge. It is also unlikely that multiple small containers will fail simultaneously; therefore, EPA is not reducing the effectiveness of SPCC plans by changing the volume threshold." (47, 61) Greater than 660 gallons. "...( T) he lack of a size limitation raised the question of whether individual, small containers (e. g., 55­ gallon drums) had to be addressed in a SPCC plan. API continues to believe that such small containers need not be addressed, and it reiterates its recommendation that the bulk storage tanks be defined as those with a capacity greater than 660 gallons." (41, 58) Other factors. "Other factors should also be considered, such as in the FRP applicability ­ owner history of, spills, proximity to surface waters, type of oil, etc." (40) Permanently connected containers. "Clarification is needed as to whether small containers that are not permanently connected to any user, such as 55 gallon drums, are to be included in the total plant capacity. We have been lead to believe, by a representative from your Agency, that drums and small containers that are not "hard piped" do not have to be included in the SPCC Plan. For example, transitory drums, whose inventory is variable, would not be considered as part of the storage capacity. In other words, only tanks and other immobile containers that are a permanent part of the facility would be subject to the capacity determination and have to be covered by the SPCC Plan." (38) Risk­ based approach. Urges a risk­ based approach instead of a storage capacity approach to SPCC regulation. (40, 46, 73, L3) "...( A) facility may exceed the 1, 320­ gallon threshold, yet may represent a comparatively low environmental risk due to the amount of time such storage capacity is actually in use (according to the Agricultural Retailers Association, oil storage capacity at many agricultural operations may be in use for less than half of the year). Other facilities may have storage capacity for more than 1, 320 gallons of oil, but may utilize only a fraction of that capacity for inventory control purposes (e. g., an operator may choose to use only 500 gallons of storage capacity in a 1, 500­ gallon gasoline tank to ensure that the stored gasoline is used before it `goes bad'; the actual volume of storage capacity in use at any time can be easily monitored based on inventory records). Facilities near the 660­ gallon and/ or 21 1,320­ gallon thresholds are generally smaller businesses with limited resources (for example, small farmers), and the costs of preparing extensive SPCC Plans (including the cost of hiring a registered professional engineer) may at times be an unnecessary burden for such facilities, given the quantities of oil actually stored. HC& S believes that the requirement to maintain an SPCC Plan should be based on the environmental risk posed by the facility rather than being strictly based upon the total storage capacity available." (46) "Numerous attempts have been made by the AST industry and endusers who wish to avoid the burdens of properly preparing a site, primarily due to economic reasons, to simply state the `site is exempt. ' Numerous manufacturers now produce fuel containers of 650 gallons designed to avoid compliance, whether the site is adjacent to a navigable waterway or not. Furthermore, the recent revelation in the December 7­ 11, 1997 UFC hearings in Tucson, Arizona where an insurance carrier complained about 350 national pollution/ property damage sites for a single AST manufacturer indicate that the problem is epidemic, not isolated! Most name­ brand tank manufacturers produce a `listed' tank of 250 gallons; naturally, six of these 250­ gallon assemblies would exceed the 1, 320­ gallon threshold currently proposed. However, five of the 250­ gallon assemblies would not qualify for the threshold and yet the risk would be nearly identical dependent upon the design of the tank." (73) Response: Exemption ­ electrical equipment. We disagree that operational equipment is not subject to the SPCC rule. We have amended §112.1( b) to clarify that using oil, for example operationally, may subject a facility to SPCC jurisdiction as long as the other applicability criteria apply, for example, oil storage capacity, or location. Such a facility might reasonably be expected to discharge oil as described in §112.1( b). Therefore, the prevention of discharges from such facility falls within the scope of CWA section 311. The definition of "facility" in OPA section 1001( 9) does not apply to this rule. However, we have distinguished the bulk storage of oil from the operational use of oil. We define "bulk storage container" in the final rule to mean any container used to store oil. The storage of oil may be prior to use, while being used, or prior to further distribution in commerce. For clarity, we have specifically excluded oil­ filled electrical, operating, or manufacturing equipment from the definition. Facilities that use oil operationally include electrical substations, facilities containing electrical transformers, and certain hydraulic or manufacturing equipment. The requirements for bulk storage containers may not always apply to these facilities since the primary purpose of this equipment is not the storage of oil in bulk. Facilities with equipment containing oil for ancillary purposes are not required to provide the secondary containment required for bulk storage facilities (§ 112.8( c)) and onshore production facilities (§ 112.9( c)), nor implement the other provisions of §112.8( c) or §112.9( c). Oil­ filled equipment must meet other SPCC requirements, for example, the general requirements of this part, including §112.7( c), to provide appropriate 22 containment and/ or diversionary structures to prevent discharged oil from reaching a navigable watercourse. The general requirement for secondary containment, which can be provided by various means including drainage systems, spill diversion ponds, etc., will provide for safety and also the needs of section 311( j)( 1)( C) of the CWA. In addition, a facility may deviate from any inapplicable or inappropriate SPCC requirements, or from most applicable requirements, if the owner or operator explains his reasons for nonconformance and provides equivalent environmental protection by some other means. See §112.7( a)( 2). See also §112.7( d). Minimum container size. In response to comments, we are introducing a minimum container size to use for calculation of the capacity of aboveground storage tanks or completely buried containers. The 55 gallon container is the most widely used commercial bulk container, and these containers are easily counted. Containers below 55 gallons in capacity are typically end­ use consumer containers. Fifty­ five gallon containers are also the lowest size bulk container that can be handled by a human. Containers above that size typically require equipment for movement and handling. We considered a minimum container size of one barrel. However, a barrel or 42 gallons is a common volumetric measurement size for oil, but is not a common container size. Therefore, it would not be appropriate to institute a 42 gallon minimum container size. You need only count containers of 55 gallons or greater in the calculation of the regulatory threshold. You need not count containers, like pints, quarts, and small pails, which have a storage capacity of less than 55 gallons. Some SPCC facilities might therefore drop out of the regulated universe of facilities. You should note, however, that EPA retains authority to require any facility subject to its jurisdiction under section 311( j) of the CWA to prepare and implement an SPCC Plan, or applicable part, to carry out the purposes of the Act. While some commenters had suggested a higher threshold level, we believe that inclusion of containers of 55 gallons or greater within the calculation for the regulatory threshold is necessary to ensure environmental protection. If we finalized a higher minimum size, the result in some cases would be large amounts of aggregate capacity that would not be counted for SPCC purposes, and would therefore be unregulated, posing a threat to the environment. We believe that it is not necessary to apply SPCC or FRP rules requiring measures like secondary containment, inspections, or integrity testing, to containers smaller than 55 gallons storing oil because a discharge from these containers generally poses a smaller risk to the environment. Furthermore, compliance with the rules for these containers could be extremely burdensome for an owner or operator and could upset manufacturing operations, while providing little or no significant increase in protection of human health or the environment. Many of these smaller containers are constantly being emptied, replaced, and relocated so that 23 serious corrosion will likely soon be detected and undetected leaks become highly unlikely. While we realize that small discharges may harm the environment, depending on where and when the discharge occurs, we believe that this measure will allow facilities to concentrate on the prevention and containment of discharges of oil from those sources most likely to present a more significant risk to human health and the environment. Effect on Facility Response Plan facilities. The exemption for containers of less than 55 gallons applies to the calculations of storage capacity both for SPCC purposes and for FRP purposes because the exemption applies to all of part 112. Therefore, a few FRP facilities might no longer be required to have FRPs. The calculations for planning levels for worst case discharges would also be affected. Permanently connected containers. It is irrelevant for storage capacity calculations whether the container is permanently connected by piping or otherwise. Mobile containers or fixed containers both pose the same risk of a discharge as described in §112.1( b). Regulatory thresholds. We have decided to raise the current regulatory threshold, as discussed in the 1997 preamble, to an aggregate threshold of over 1, 320 gallons. We believe that raising the regulatory threshold is justified because our Survey of Oil Storage Facilities (published in July 1996, and available on our web site at www. epa. gov/ oilspill) points to the conclusion that several facility characteristics can affect the chances of a discharge. First, the Survey showed that as the total storage capacity increases, so does the propensity to discharge, the severity of the discharge, and the costs of cleanup. Likewise, the Survey also pointed out that as the number of tanks increases, so does the propensity to discharge, the severity of the discharge, and the costs of cleanup. Finally, the Survey showed that as annual throughput increases, so does the propensity to discharge, the severity of the discharge, and, to a lesser extent, the costs of the cleanup. The threshold change will have several benefits. The threshold increase will result in a substantial reduction in information collection. Some smaller facilities will no longer have to bear the costs of an SPCC Plan. EPA will be better able to focus its regulatory oversight on facilities that pose a greater likelihood of a discharge as described in §112.1( b), and a greater potential for injury to the environment if a discharge as described in §112.1( b) results. We raise the regulatory threshold realizing that discharges as described in §112.1( b) from small facilities may be harmful, depending on the surrounding environment. Among the factors remaining to mitigate any potential disasters are that small facilities no longer required to have SPCC Plans are still liable for cleanup costs and damages 24 from discharges as described in §112.1( b). We encourage those facilities exempted from today's rule to maintain SPCC Plans. Likewise, we encourage new facilities which are exempted from the rule to develop Plans. We believe that SPCC Plans have utility and benefit for both the facility and the environment. But, we will no longer by regulation require Plans from exempted facilities. While we believe that the Federal oil program is best focused on larger risks, State, local, or tribal governments may still decide that smaller facilities warrant regulation under their own authorities. In accord with this philosophy, we note that this Federal exemption may not relieve all exempted facilities from Plan requirements because some States, local, or tribal governments may still require such facilities to have Plans. While we are aware that some States, local, or tribal governments have laws or policies allowing them to set requirements no more stringent than Federal requirements, we encourage States, local, or tribal governments to maintain or lower regulatory thresholds to include facilities no longer covered by Federal rules where their own laws or policies allow. We believe CWA section 311( o) authorizes States to establish their own oil spill prevention programs which can be more stringent than EPA's program. Alternative thresholds. We continue to believe that a facility with a storage or use capacity greater than 1,320 gallons should be subject to the SPCC rule and be required to prepare and implement a prevention plan. We believe that SPCC Plans help to prevent discharges as described in §112.1( b) and resulting cleanups We disagree with the commenter that our presentation of survey results was intended to imply that storage capacity below 10,000 gallons is not of regulatory concern. The Survey shows that the predicted relationship between total tank capacity and annual spill volume remains the same for facilities storing less than 10,000 gallons as those storing more. Because we believe that the same preventive measures are applicable for most facilities, we apply those measures to all regulated SPCC facilities. Where those measures are not applicable, the owner or operator may deviate from the requirement if he provides reasons for nonconformance and provides equivalent environmental protection. 40 CFR 112.7( a)( 2). Completely buried tanks ­ threshold. We proposed no changes in the threshold for completely buried tanks. We note, however, that such tanks that are subject to all of the technical requirements of 40 CFR part 280 or a State program approved under 40 CFR part 281 are no longer subject to part 112. Regulatory safeguard. When a particular facility that is below today's threshold becomes a hazard to the environment because of its practices, or for other reasons to effectuate the Clean Water Act, the Regional Administrator may, under a new rule provision, require that facility to prepare and implement an 25 SPCC Plan. See §112.1( f). This provision acts as a safeguard to an environmental threat from any exempted facility. Risk­ based approach, other factors. We believe that a program based on potential storage capacity is necessary, rather than a risk­ based approach, because the potential storage capacity may be changed, at the owner's or operator's option. A facility with a storage capacity above the threshold amount poses sufficient risk to the environment to warrant an SPCC Plan due to the amount of oil which could be discharged. The SPCC rules adopt a risk­ based approach in that they seek to prevent threats to the environment based on the risk of a potential discharge as described in §112.1( b). If any requirement is inappropriate for any facility, the owner or operator may explain his reasons for nonconformance and provide equivalent environmental protection. 26 5. §§ 112.2 and 112.7 Introduction ­ Alternative Plan Formats Background: In 1991, we proposed a definition for "SPCC plan or Plan." In 1997, we withdrew the 1991 proposed definition in favor of a revised definition. The revised definition would describe an SPCC plan and would allow any alternative format acceptable to the Regional Administrator if it: (1) meets all regulatory requirements in the SPCC rule; and (2) is cross­ referenced by SPCC rule provision to the equivalent requirement in the other plan. We proposed to amend both §112.2 and the introduction to §112.7 to effect this change. Comments: Support for proposal. "Reynolds wholeheartedly supports EPA's proposal to allow alternative plans to meet SPCC Plan requirements. Use of plans such as the Integrated Contingency Plan or equivalent State plans which meet the requirements of 40 CFR 112 will satisfy the goals and objectives of the SPCC program and facilitate safe, efficient incident prevention and response activities." (10, 11, 14, 17, 22, 23, 26, 28, 32, 34, 37, 38, 41, 42, 45, 51, 55, 56, 58, 65, 66, 67, 71, 73, 74, 79, 80, 82, 83, 84, L1, L5). Opposition to proposal. Substantive requirements. "The last two sentences in the proposed definition of SPCC plan in section 112.2 contain substantive requirements and should therefore be deleted and relocated to section 112.7 which is there in reference. (3) "In the past an SPCC plan was a written description of physical measures taken to prevent the discharge of oil, the release of which could possibly impact a navigable water; or as in 112.5( a) a plan amendment is required if changes are made to `Facility design, construction, operation and maintenance which materially affects the facility's potential for the discharge of oil into or upon the navigable waters of the United States. ' The definition proposed today is far reaching, requiring `details of equipment, manpower, procedures and steps to prevent, control and provide adequate countermeasures to an oil spill. ' " (6) Other problems. "It is my opinion that the ICP concept is over­ rated. ... How is an Engineer to certify an ICP? ... Sequential cross­ referencing could be a nightmare. The EPA requires that they review and approve state plans for USTs; are they not requiring approval of each State Plan for oil spills?" (40) API D16 format. "While being able to use an ICP or a State Plan will help consolidate plans and eliminate duplication, we are concerned that the proposal unduly constrains the plan formats by restricting it to ICP format or State Plans. Since 1974, E&) operations have successfully implemented the API format (API Bulletin D16). ... RMOGA encourages EPA to allow the continued use of the API D16 format for small, non­ OPA­ 90 facilities...." (8, 49) 27 Cross­ referencing. Support for cross­ referencing. "The requirement to sequentially cross­ reference the alternative plan ensures that it is substantively equivalent to the guidelines prescribed in Section 112.7. Any further requirement to obtain the Regional Administrator's approval of a sequentially cross­­ referenced plan would be an exercise in redundancy at odds with the purpose of this proposal to reduce the information collection burden of the SPCC rule." (21) Opposition to cross­ referencing. "With no requirement to submit SPCC Plans to the Agency for review and/ or approval, the cross­ referencing creates an additional administrative burden with no recognizable benefit. As long as the single comprehensive plan contains elements which comply with the § 112.7 regulations, there should be no need for a cross­ referencing requirement. The burden should be, and is, on the regulated entity to comply with the regulations through the preparation of SPCC Plans as appropriate." (43) Editorial suggestion. "On page 18 in §112.2, the phrase `... be sequentially cross­ referenced… should be `... be cross­ referenced..., since it is not clear which sequence in which plan is being referred to. The ICP guidance refers to `matrices, which is a slightly different approach than cross­ referencing." (16) Level of cross­ referencing. "At what level is a cross­ reference required? 112.7 or 112.7( a); 112.7( c) or 112.7( c)( 1) or 112.7( c)( 1)( I)? What if, at the lowest level, the cross­ reference is at two or more locations in the other format? (e. g, 112.7( e)( 1)( ii) ­ Existing plant drainage may be discussed in one section of the ICP but the responsibility to review proposed construction of new catchment basins may be located in another section of the ICP? " (40) EPA approval of format. Should not be required. Equivalent formats that are consistent with 40 CFR 112.7 requirements are acceptable SPCC plans that should not require the approval of the Regional Administrator. The rule as it is presently written does not properly reflect this sentiment, and therefore we should clarify it. (21, 41, 47, 52, 58, 61, 77) Editorial suggestion ­ compliance. "The plan is required to comply with the regulation, but is not a written document of compliance. Compliance is determined by comparing the contents of the plan with the regulations." (47, 61) 28 Integrated Contingency Plans (ICPs). Supports proposal to include the ICP as an example of an acceptable SPCC plan format. (3, 7, 21, 40, 41, 48, 51, 52, 58) Use of a single plan in situations where a single entity operates a number of facilities that are similar in design would substantially reduce the paperwork burden on the owner or operator of the facilities while maintaining the same level of environmental protection. Using a single plan would reduce the burdens associated with plan maintenance without any reduction in environmental protection. (31) Burden would not be reduced. "... (T) he ICP concept is over­ rated. If operators want to prepare a consolidated training plan and a consolidated response plan, they have always had the right to do so." (7, 40) . Extent of integration. "In the event one selects the Integrated Contingency Plan format, will it be required to include all related plans at a facility or will partial integration at the selection of the facility be acceptable? The proposal appears to be silent on this point. Michelin suggests that the rules be written to state that facilities will have the flexibility of partial integration to avoid the potential reservations a preparer may have for undertaking the much greater task of producing a totally unified plan in one project." (3) Information collection burden. "EPA does not contemplate that the use of an ICP or other format would reduce the information collection burden, but it would simplify compliance with multiple applicable statutes and rules. Unfortunately, "information collection" (and updating, verification, validation, display, organization, structure, presentation, analysis, storage and archiving of the massive amount of information after collection) is ninety­ nine percent of the burden (especially costs) of compliance; actual spill emergencies occupy the remaining one percent. The statement conflicts with another statement on page 1: `... the proposal would maintain the same standards of environmental protection while reducing its information collection burden. '" (16) Multi­ facility plans (electric utilities and other operational users of oil. Supports our approval of a facility area response plan format as an alternative to site­ specific SPCC plans. (18, 20, 31, 35, 57, 60, 61, 65, 69, 70) In order to avoid misinterpretation at the EPA regions and state levels, the regulation should specifically mention the allowance of system­ wide response plans for electrical equipment. (57) Electrical equipment (area­ wide response plans). The EERP is "... a document that describes the utility's procedures for responding to releases of dielectric fluid from electrical equipment. This type of plan would describe the positioning of response crews and equipment, identify procedures for contacting response contractors if needed, and describe the procedures that spill responders would use to contain a spill and summon additional assistance if necessary. The scope of the proposed EERP would not address every aspect of an SPCC plan 29 or an OPA response plan because those programs were designed to apply to oil storage and transfer facilities. However, as we have described in the past, the risks posed by electrical equipment are de mini mis, when the totally enclosed nature and structural strength of the equipment, its operational characteristics, and its spill history are properly taken into account." (20, 31) The following characteristics of electrical equipment require that such equipment be subject to different SPCC requirements, documented in area response plans in lieu of site­ specific SPCC plans: 1. Electrical equipment is built to more stringent standards than typical tanks. 2. Most units are effectively self­ monitoring because the release of dielectric fluid results in an interruption in the transmission of electric power. 3. Dielectric fluid is infrequently added to or removed from electrical equipment, practically eliminating transfer­ related releases. 4. The mineral oil contained in electrical equipment has substantially lower toxicity than fuel oils. Also, there are very few soluble components in mineral oil, minimizing its potential to damage aquatic ecosystems. 5. All utilities with electric distribution systems have mobile crews that are trained and equipped to respond to releases from electrical equipment. When a release is reported or detected through inspection or alarm, a crew is dispatched to the facility. 6. Many utilities not only have these systems in place, but also have them documented in the form of policies, response plans, or response manuals. (31) "The equipment containing significant oil can be inspected for its adjacency to traffic. If the risk of vehicular impact is high, traffic barriers can be constructed to prevent collisions. This process will vastly reduce the most common cause of a release. During the above inspections, a determination can be made to decide if some equipment should be protected with secondary containment. Also during the inspections, the equipment can be checked for any areas of concern. Should a problem be identified, measures can be taken to mitigate the problem. A general spill prevention response procedure can be written for distribution equipment, and corresponding training be given, so employees can take measures to prevent spills and can respond appropriately to a spill. (Note: SPCC training is already given to these employees for substation equipment.) Also note that distribution equipment is currently labeled with an emergency call number should a passerby note anything peculiar." (32) "The plan is recommended to include: (1) Identification of all facilities containing electrical equipment subject to the Plan; (2) The location of available equipment 30 to respond to releases of dielectric fluid for electrical equipment (the equipment may be located at the facilities, in mobile response units, or in one or more central locations); (3) The training of employees to identify, characterize, and respond to releases of dielectric fluid; (4) The identification of equipment, personnel, and/ or contractors to respond to releases of dielectric fluid; and, (5) Procedures for notification, internal and where applicable, the National Response Center, state and local authorities. ' (60) Paperwork reduction. "Significant reductions in the paperwork requirements of the SPCC regulation could be made if EPA allowed the use of response plans for electrical equipment, which electric utilities already have in place, in lieu of site­ specific SPCC plans." (31, 35) Other formats. Asks for clarification concerning whether we would allow different formats, in addition to the ICP, to be acceptable for SPCC purposes. (3, 8, 21, 30, 31, 41, 42, 47, 48, 49, 52, 58, 61) Any alternate formats should be allowed so long as these formats are consistent with the requirements outlined in 40 CFR 112.7. (42, 47, 61) State plans. "In an effort to comply with the President's regulatory reform directive, the Company urges the Agency to allow alternative spill plan formats and the Integrated Contingency Plan to be used to fulfill the requirements of the SPCC regulations. Michigan law requires facilities to prepare and implement a spill control plan if they meet the applicability requirements of the Michigan Natural Resources and Environmental Protection Act, Part 5, Spillage of Polluting Materials. The applicability requirements are similar to those of the SPCC regulations. Requiring facilities to prepare an additional plan would not be justified under the President's regulatory reform directive nor the paperwork reduction requirements of the SPCC regulation. (76) EPA approval. "The EPA requires that they review and approve state plans for USTs; are they not requiring approval of each State Plan for oil spills? How about a list of States with such plans or approved plans?" (40) SWPPP. Commenters urge "the Agency to consider the applicability of a NPDES Storm Water Pollution Prevention Plan (SWPPP) as an acceptable format since spill prevention and response is an integral, and critical part of a SWPPP." (30, 42) Tank manufacturers. "Section 112.2 Definitions "Spill Prevention, Control, and Countermeasure Plan; SPCC Plan; or Plan means the document..... The Plan is a written document...... It is prepared in writing and in accordance with the format specified..... If a tank manufacturer or owner or operator of a facility chooses to prepare a plan using either the Integrated Contingency Plan format or a State format or any 31 other format acceptable to the Regional Administrator, such plan must meet all of the requirements in section 112.7, and be sequentially cross­ referenced from the requirement in section 112.7 to the page( s) of the equivalent requirement in the other plan. Rationale. As previously submitted by SPC Corp, a key component in implementing a cost­ effective, easily­ audited national Oil Pollution Prevention program is the participation of the tank manufacturing community; this would immeasurably increase the US EPA
s database while correctly linking tank purchase, installation and owner/ operator maintenance to achieve the goals of the program. Non­ compliance discovery/ corrective action could be expedited under this format as well." Suggests a modification of the rule to place the initial responsibility for information upon the tank manufacturer much like the requirement in UST regulations. This would "... remove the confusion of who must comply by generating a database for the Agency which will place all existing and new owner/ operators on notice to inquire about compliance. Simply put, at the point of sale, the tank manufacturer will reference on his/ her invoice the need to contact the appropriate federal, state and/ or local agency and REGISTER the tank with site specific information such as gallonage, type of tank construction (singlewall/ bare steel versus protected tank, e. g.) In addition, the tank manufacturers will independently provide the Agency with an historical data base with the pertinent information as previously outlined so that the Agency may notify end­ users of the need to implement an SPCC or FRP Plan." (73) Written plans. "First, on page 18 in the above document, §112.2 Definitions, `written description
should be further annotated as meaning `text, graphs, charts, maps, photos, and tables, on whatever media, including floppy, CD, hard drive, and tape storage that allows the document to be easily accessed, comprehended, distributed, viewed, updated and printed... ' This phraseology supports the various initiatives underway to automate plans in electronic format. (This phrasing should also be applied to the Integrated Contingency Plan, the Facility Response Plan, and any other plan to be subsumed within an ICP.)" (16) Response: Support for proposal. We appreciate commenter support. Substantive requirements. We have transferred all of the proposed substantive requirements in the 1997 proposed definition of "SPCC Plan" to the introduction of this section. We did this because we agree with commenters (see the comments on the definition of" SPCC Plan" in §112.2) that definitions should not contain substantive requirements. Acceptable formats. We agree that any equivalent prevention plan acceptable to the Regional Administrator qualifies as an SPCC Plan as long as it meets all Federal requirements (including certification by a Professional Engineer), and is crossreferenced from the requirement in part 112 to the page of the equivalent plan. We do 32 not agree that we should specify acceptable formats. We will give examples of those acceptable formats, but those examples are not meant to be exhaustive. Examples of an "equivalent prevention plan" might be, for instance, an Integrated Contingency Plan, a State plan, a Best Management Practice Plan (which is a component of the Storm Water Pollution Prevention Plan), or other plan that meets all the requirements of part 112 and is supplemented by a cross­ reference section identifying the location of elements in part 112 to the equivalent requirement in the other plan. If the equivalent prevention plan has no requirement that a Professional Engineer certify it, it will be necessary to secure proper certification from the Professional Engineer to comply with the SPCC rule. Another example of an equivalent plan might include a multi­ facility plan for operating equipment. This type of plan is intended for electrical utility transmission systems, electrical cable systems, and similar facilities which might aggregate equipment located in diverse areas into one plan. Examples of operating equipment containing oil include electrical equipment such as substations, transformers, capacitors, buried cable equipment, and oil circuit breakers. A general, multi­ facility plan for operational equipment used in various manufacturing processes containing over the threshold amount of oil might also be acceptable as an SPCC Plan. Examples of operating equipment used in manufacturing that contains oil include small lube oil systems, fat traps, hydraulic power presses, hydraulic pumps, injection molding machines, auto boosters, certain metalworking machinery and associated fluid transfer systems, and oil based heaters. Whenever you add or remove operating equipment in your Plan that materially affects the potential for a discharge as described in §112.1( b), you must amend your Plan. 40 CFR 112.5( a). Multi­ facility plans would include all elements required for individual plans. Sitespecific information would be required for all equipment included in each plan. However, the site­ specific information might be maintained in a separate location, such as a central office, or an electronic data base, as long as such information was immediately accessible to responders and inspectors. If you keep the information in an electronic data base, you must also keep a paper or other backup that is immediately accessible for emergency response purposes, or for EPA inspectors, in case the computer is not functioning. Where you place that site­ specific information would be a question of allowable formatting, as is the question of what is an "equivalent" plan; an issue subject to RA discretion. Still another example of an equivalent plan might be a Best Management Practice Plan (BMP) plan prepared under an NPDES permit, if the plan provides protections equivalent to SPCC Plans. Not all BMP plans will qualify, as some BMP plans might 33 not provide equivalent protection. NPDES permits without BMP plans would not qualify. BMP plans are additional conditions which may supplement effluent limitations in NPDES permits. Under section 402( a)( 1) of the CWA, BMP plans may be imposed when the Administrator determines that such conditions are necessary to carry out the provisions of the Act. See 40 CFR 122.44( k). CWA section 304( e) authorizes EPA to promulgate BMP plans as effluent limitations guidelines. NPDES rules provide for BMP plans when: authorized under section 304( e) of the CWA for the control of toxic pollutants and hazardous substances; numeric limitations are infeasible; or, the practices are reasonably necessary to achieve effluent limitations and standards to carry out the purposes of the CWA. Cross­ referencing. We agree that the term "sequential" cross­ referencing may be confusing, and have therefore deleted it in favor of a requirement to provide crossreferencing We disagree that cross­ referencing provides no benefit. With the wide variation now allowed in differing formats, we need cross­ referencing so that an inspector can tell whether the Plan meets Federal requirements, and whether it is complete. In addition, in order for an owner or operator to do his own check to ensure that his facility meets all SPCC requirements, he must go through the exercise of comparing his Plan to each SPCC requirement. Cross­ referencing in the context of the rule means indicating the relationship of a requirement in the new format to an SPCC requirement. The cross­ referencing must identify the Federal section and paragraph for each section of the new format it fulfills, for example, §112.8( c)( 3). Note the crossreferencing table we have provided for your convenience in section II. A of today's preamble. An equivalent Plan might be a Plan following the SPCC sequence in effect before this final rule became effective. If you choose to use the sequence of the rule currently in effect, you may do so, but you must cross­ reference the requirements in the revised rule to the sequence used in your Plan. We have provided a table in section IV. A of today's preamble to help you cross­ reference the requirements more easily. If the only change you make is the addition of cross­ referencing, you need not have a Professional Engineer certify that change. EPA approval of format. Any format that contains all the required elements of an SPCC Plan and provides equivalent environmental protection would be presumptively acceptable. The final decision on what is an "equivalent" plan, however, would be at the discretion of the Regional Administrator. "Equivalence" would not mean that an alternate format would be the mirror image of an SPCC Plan, but it would have to contain all the required elements of an SPCC Plan. Required elements include, but are not limited to, provisions for a written plan, secondary containment or a contingency plan following 40 CFR part 109, equivalent inspections and tests, security, personnel 34 training, and certification of the plan by a Professional Engineer. Acceptance of an equivalent plan does not, however, imply any type of approval or submission process. As before, SPCC Plans are generally not submitted to the Regional Administrator. The Regional Administrator could accept an equivalent prevention plan if it: (1) meets all regulatory requirements in the SPCC rule; and (2) is supplemented by a crossreference section identifying requirements listed in part 112 to the equivalent requirements in the other prevention plan. Partial use of other equivalent prevention plans is also acceptable, if the plan is supplemented by elements that meet the remainder of the EPA requirements contained in part 112. Editorial suggestion ­ compliance. We agree that the Plan does not document compliance, but merely spill prevention measures and have deleted the sentence noting that the Plan documents compliance with the rules. Compliance is determined by comparing the contents of the Plan with the regulations. Integrated Contingency Plans (ICPs). If an owner or operator uses the ICP format, total or partial integration of other Plans is acceptable, at the owner's or operator's option. We never said that use of the ICP would reduce the information collection burden, but that it would simplify compliance with multiple applicable statutes and rules. The Professional Engineer (PE) must certify the SPCC portion of the ICP. PE certification of other parts of the ICP is only necessary if required by some other authority. Response Plan. We disagree that the proposed definition constitutes a "response plan." The definition results in no substantive changes in response planning requirements. State plans. We do not maintain a list of States with oil discharge prevention programs. It is the responsibility of the owner or operator to inform himself of State requirements. However, the Office of Underground Storage Tanks maintains a list of States with programs approved pursuant to 40 CFR part 281. Tank manufacturers. We decline to make the requested change because the owner or operator of the facility, not the tank manufacturer, is responsible for the preparation and implementation of a Plan. Written plans. We agree that a "written" Plan might also include texts, graphs, charts, maps, photos, and tables, on whatever media, including floppy disk, CD, hard drive, and tape storage, that allows the document to be easily accessed, comprehended, distributed, viewed, updated, and printed. Whatever medium you use, however, must be readily accessible to response personnel in an emergency. If it is produced in a medium that is not readily accessible in an emergency, it must be also available in a medium that is. For example, a Plan might be electronically produced, but computers fail and may not be operable in an emergency. For an electronic Plan, therefore, a 35 backup copy must be readily available in another medium. At least one version of the Plan should be written in English so that it will be readily understood by an EPA inspector. 36 6. Information Submitted After Certain Discharges ­ §112.4( a) Background: In 1991, we proposed to require more information than is currently required in the rule for reporting certain discharges. If your facility discharged more than 1,000 gallons in a discharge as described in §112.1( b), or discharged oil in quantities that may be harmful in more than two discharges as described in §112.1( b) within any consecutive twelve month period, you would have been required to submit certain information to the Regional Administrator. In 1993, we proposed a modification to §112.4( d)( 1) which would allow the Regional Administrator to require the submission of the listed information in §112.4( a)( 1) at any time, whether or not there had been a discharge as described in §112.1( b). In 1997, we proposed a reduction of the amount of information currently required by §112.4( a). We proposed to eliminate the following information, unless the Regional Administrator specifically requested it: (1) the date and year of initial facility operation; (2) maximum storage or handling capacity of the facility and normal daily throughput; and, (3) a complete copy of the SPCC Plan with any amendments. Comments: Support for proposal. (10, 14, 23, 30, 34, 37, 41, 42, 43, 52, 55, 57, 58, 67, 71, 80, 82, 84, L1, L5) "In the case of the first two items, the agency may already have this data, which is useless for responding to the environmental threat. In the case of the SPCC plan submittal, this action will reduce the amount of paperwork that the agency may try to plow through in the initial phase of containment or cleanup. The relevant data of the SPCC is required to be sent to EPA separately so there is no need to duplicate this information by sending the SPCC plan." (42) "The reporting requirements that EPA has proposed to eliminate are not necessary as part of a postspill report to accurately assess the spill, In addition, ... the Regional Administrator has authority to request additional information pertinent to a spill event, as needed, and so retains authority to access the information which USEPA is proposing for elimination from the rules." (43) "...( M) uch of the information required in reporting a release according to the SPCC guidelines is not necessary. Insignificant items such as date and year of initial operation, and daily throughputs provide little help in analyzing a spill event and may delay facility response time. We agree that it should be left to the regulators discretion whether they need to see an SPCC plan with an amendment after a release." (56) Opposition to proposal. Duplicative information. We should "... take a more significant step to eliminate the paperwork burden by deleting this duplicative reporting requirement in its entirety. Spill reports must be made for these same spills under various other EPA programs, such as the Clean Water Act and the Emergency Planning and 37 Community Right­ to­ Know­ Act. If burden reduction without diminishing environmental protection is the goal, the deletion of the spill reporting requirement will provide the regulated community with a substantial measure of relief." (31) "... (T) he regulations should not require persons to review their SPCC plan and report (to the state and EPA) after any two spills to navigable water in a 12­ month time frame. This requirement entails production of much paper (flow diagrams, topographical maps, failure analyses, descriptions of corrective action measures, repairs, and additional preventive measures, and a complete copy of the SPCC plan) and is in two senses duplicative. First, spill reports must be made for these same spills under various other EPA programs, such as the Clean Water Act and Emergency Planning Community Right to Know Act. Second, EPA often already has some of these documents (e. g. the SPCC plan). Further, even if EPA drops the 12­ month requirement, the agency will still receive information under the SPCC program of significant releases (releases over 1000 gallons)." (65) Entire Plan needed. "Elimination of the need to submit a copy of the SPCC Plan after a substantial release is, with all due respect, just plain stupid. How could the EPA possibly evaluate the REAL cause of a spill if you do not have the most vital piece of information? This is silly. At least require that they certify that they have a SPCC Plan; that they were, or were not, in full compliance with the Plan at the time of the release; and the name of the certifying engineer." (40) Little consequence. "These post­ 60 day spill reports to Regional Administrators do not appear to have been done in the past. A query in the past to Regional Offices was unable to ascertain where such reports should be sent. Increased staffing of Regional Offices since then may have made such reporting useful. In any case, the reduced reporting is acceptable although of little consequence." (7) Proposal a "sham." "The proposed rule provides for the Regional Administrator [RA] to request the three items for elimination. Based on long experience with the Agency, we know the RA will request the data. Accordingly, the proposal is a sham. Recommendation: Do not modify the current SPCC plan rule." (8) Calculation of time for discharge reports required by §112.4( a). "Block" basis. Support for block basis. (21, 31, 70, 76). Urges that "...( T) he reporting provision be revised to specify the block count. Notification must still be provided to the National Response Center (NRC) for all spill events. The use of a `block' basis reduces the reporting burden without compromising EPA's ability to obtain timely information." (21) "EPA's intent in the current rulemaking to clarify the standards and reduce the regulatory burden without adversely 38 affecting human health or the environment would be further implemented if EPA makes clear that the oil spill reporting requirement specified in section 112.4( a) is based on consecutive annual periods, rather than a rolling basis... The use of the "block" basis reduces the reporting burden without compromising EPA's receipt of timely information. All spill events, whenever they occur, still must be reported to the NRC and the use of "block" reporting avoids needless duplication. (31) Discharge threshold ­ each discharge. 25 gallons ­ each discharge, offsite category. Urges "( S) etting a 25­ gallon threshold for the multiple spill reporting requirement; Create an `off­ site report' category (in which off­ site reports would not count towards the two­ spills quota; Relax the reporting requirements for very minor releases of petroleum products to storm drains, or other man­ made structures; Implement a retraction feature if the sheen dissipates within 24 hours." (65) 42 gallons ­ each discharge. Written reports should only be required if the spills exceed an aggregate volume of 42 gallons. (60, 70, 76) "We have had several occasions where our power plants released very small amounts of oil, less than one pint, twice within 12 months which initiated the written reporting requirement. In no case has the reason for the spills been a recurring problem with a storage system, but normally a release of a small amount of oil from a lube pipe leak, oil level sight glass crack, etc. Since the volume of a single spill which triggers the reporting requirement indicates that mainly large spills are of concern to the agency, these small spills create a reporting burden on the regulated community and a monitoring burden on the Agency. While we continue to support the verbal reporting of all spills to navigable water to the National Response Center and the applicable state and local authorities, the provision to provide written follow­ up when the aggregate volume of the two spills is very small is unnecessary. We propose that written follow­ up be provided when the aggregate volume of two spills within a twelve month period exceeds 1 barrel (42 gallons). " (60) Discharge threshold ­ 1,000 gallon discharges. 55 gallons. "...( A) ny discharge in excess of 55 gallons [should] be considered a reportable incident. This will create a database which accurately reflects the cause of the discharge, the corrective action, and any liabilities or need for ongoing supervision. To suggest to the fuel storage owner/ operator community that thresholds are being raised to exempt current carelessness will, most probably result in an interpretation that the Agency does not have concerns for 39 discharges of less than 1,000 gallons! As most surveys have demonstrated over 90% of discharges are less than 1,000 gallons." (73) Maps, flow diagrams, and charts. Opposes mandatory submission of maps, flow diagrams and charts. (31, 60, 70, 76) "( T) his information will be of no additional benefit to the Agency. The majority of spills which have been reported by AEP are normally less than one (1) gallon and in most cases less than one (1) pint. Submitting maps, diagrams and charts adds bulk to the report without added substance. We recommend that the owner or operator have the option to submit the maps, diagrams and charts as needed to completely describe the spill or actions taken." (60) Response: Support for proposal. We appreciate commenter support. Additional information. If the Regional Administrator requires other information, for example, concerning the spill pathway, or any response measures taken, this request is authorized under renumbered §112.4( a)( 9), current §112.4( a)( 11). Adjoining shorelines, natural resources, affected natural resources. Discharges into navigable waters are not the only discharges reportable for purposes of this section. We note that any discharge as described in §112.1( b) is also within the scope of this section's reportable discharges. Calculation of time for discharge reports required by §112.4( a). We believe a "rolling" basis is the appropriate method to calculate a discharge as described in §112.1( b) for purposes of the rule because discharges as described in §112.1( b) that are closer in time are more likely to be related in cause. Discharges that are more proximate in time may indicate a problem that needs to be remedied. A "rolling basis" means that each discharge as described in §112.1( b) triggers the start of a new twelve month period. For example, if discharge #1 occurred on January 1, and if discharge #2 occurred on June 2, discharge #2 would trigger the regulatory submission and would start a new twelve month period. If discharge #3 occurred on the following February 3, it would again trigger a submission, because discharge #3 would be within 12 months of discharge #2. While the "rolling basis" would trigger more regulatory submissions than the "block basis," we believe that it would enhance environmental protection because it would call potential problems to the attention of the Regional Administrator sooner, and allow them to be remedied sooner by a Plan amendment where necessary. "Block" basis. The other approach would be to use a "block" period. Under this type of calculation, each third discharge as described in §112.1( b) would not trigger a submission if it occurred within 12 months of discharge #2, but it would start the beginning of a new 12 month period. For example, if discharge #1 occurred on January 1, and discharge #2 on June 2, discharge #2 would trigger a submission. Discharge #3 on the following February 3 would not trigger a 40 submission, but would start a new 12 month period. The principal justification for block reporting is also that discharges more closely related in time are more likely to be related. Our concern with this method is that if the February 3 discharge (i. e., discharge #3) is within twelve months of discharge #2, this situation could indicate that there is a problem that has not been remedied, so the February 3 discharge should trigger a reporting submission. Declaration of compliance. We also disagree that a declaration of compliance by the owner or operator is necessary. In many cases such a declaration would only be selfserving Ultimately, whether a facility is in compliance with the rule is a determination for the RA to make. Discharge threshold. 42 gallons. We agree that a higher threshold of reporting discharges is justifiable because we believe that only larger discharges should trigger an EPA obligation to review a facility's prevention efforts. We also agree that a higher threshold should trigger a facility's obligation to submit information and possibly have to take further prevention measures. Therefore, we have changed the threshold for reporting after two discharges as described in §112.1( b). Under the revised rule, if you are the owner or operator of a facility subject to this part, you must only submit the required information when in any twelve month period there have been two discharges as described in §112.1( b), in each of which more than 42 U. S. gallons, or one barrel, has been discharged. We adopted the 42 gallon threshold on a commenter's suggestion. We believe that a 42 gallon threshold is the appropriate one to trigger a facility's information and possibly to have to take further prevention measures. When multiple discharges occur at a facility subject to the SPCC program, such as a generating station, they often involve the discharge of very small amounts of oil, and these discharges tend to come randomly from a lube pipe, an oil level sight glass crack, or some other apparatus, and do not normally indicate a recurring problem with the container. Having two or more of these small discharges does not indicate that the facility's SPCC Plan requires revision. The other reporting threshold of 1, 000 gallons in any a single discharge as described in §112.1( b) remains the same. Facility owners or operators must continue to report to the National Response Center discharges of oil that cause a sheen or are in other ways harmful, as specified in 40 CFR part 110. See the discussion below under "Sheen" rule. We disagree that a sheen caused by a discharge as described in §112.1( b) over the threshold amount that disappears within 24 hours should not require submission of information. The discharge itself may indicate a serious problem at the facility which needs to be corrected. The discharge report may give us the information necessary to require specific correction measures. Inapplicable information. If a particular information request is inapplicable, you may omit it, but must explain why it is inapplicable. 41 Information submission at any time. We agree with the commenter that the 1993 proposal to give the Regional Administrator authority to require submission of the requested information in this section at any time is vague, and have therefore withdrawn that part of the proposal. We will only require such information after the discharges specified in this section. Maps, flow diagrams, and charts. In response to comments which questioned the usefulness of such information, we have modified the provision regarding maps, flow diagrams, topographical maps (now required by paragraph (a)( 6) of the current rule) to clarify that only the information necessary to adequately describe the facility and discharge, such as maps, flow diagrams, or topographical maps is necessary ­ not necessarily all of the information listed in the paragraph. To effect this change, we added the words "as necessary" after "topographical maps." "As necessary" means as determined by the owner or operator, subject to the obligations of this rule, unless the RA requests more information. There might be circumstances in which the owner or operator would submit only a brief description of the facility or a map, for example, because flow diagrams and topographical maps were unnecessary to describe the discharge, and would not help the RA to determine whether any amendment to the Plan was necessary to prevent future discharges as described in §112.1( b). Maximum storage or handling capacity. In 1997, we proposed deletion of current paragraph (5) (renumbered as paragraph (4) in today's final rule), concerning the maximum storage or handling capacity of the facility and normal daily throughput. We have reconsidered this proposal and decided to withdraw it because the referenced information is necessary information. We have therefore retained the language in the rule. Storage capacity and normal daily throughput are important indicators of the impact of a potential discharge as described in §112.1( b). Off­ site category. There is no necessity for an "off­ site" category of discharges as described in §112.1( b) because only a discharge as described in §112.1( b) that originates in a facility subject to this part counts for purposes of §112.4( a). "Sheen" rule. The duty imposed by the CWA to report to the National Response Center all discharges that may be harmful, further described by 40 CFR 110.3, is unchanged. Those discharges include discharges that violate applicable water quality standards; or, cause a film or sheen upon or discoloration of the surface of the water or adjoining shorelines or cause a sludge or emulsion to be deposited beneath the surface of the water or upon adjoining shorelines. Submission of entire Plan. CWA section 311( m) provides EPA with the authority to require an owner or operator of a facility subject to section 311 to make reports and provide information to carry out the objectives of section 311; and CWA section 308( a) 42 provides us with authority to require the owner or operator of any "point source" to make such reports as the Administrator may reasonably require. Therefore, we disagree that submission of the entire Plan is always necessary when reporting discharges under §112.4( a). We believe the information now required to be submitted is adequate to assess the cause of discharge and the ability of the facility to prevent future discharges. If the RA believes that the entire Plan has utility, he can request it. However, we disagree that RAs will always require submission of the Plan, or other information not required, as a matter of course. RAs may use their administrative discretion not to require the submission of a Plan or other additional information. 43 7. Five Year Plan Review and Certification ­ §112.5( b) Background: Current §112.5( b) requires that an owner or operator of a facility subject to §112.3( a), (b), or (c) complete a review and evaluation of the SPCC Plan at least once every three years from the date the facility becomes SPCC regulated. At the time of review, the owner or operator must amend the SPCC plan if more effective control and prevention technology would significantly reduce the likelihood of a spill and if the technology has been field­ proven at that time. In 1997, we proposed to extend this review period from at least once every three years to at least once every five years. Also in 1997, we proposed that the owner or operator must certify completion of the review and evaluation. The certification would include a signed and dated statement that indicates that the review has taken place and whether or not amendment of the Plan is required. The statement would be part of the Plan or in a log or an appendix to the Plan. Comments: Support for proposal. "Reynolds supports changing the review and evaluation cycle for SPCC Plans from once every three years to once every five years. Because of the existing requirement to modify the plan when substantive facility changes occur, the increased 5 year review will not decrease the accuracy and validity of the plan information. In addition, the 5 year cycle is consistent with certain state review cycles (e. g., Virginia's Oil Discharge Contingency Plan)." (2, 3, 4, 5, 7, 14, 17, 21, 22, 23, 26, 27, 28, 29, 30, 32, 34, 37, 38, 42, 43, 45, 46, 48, 49, 51, 52, 55, 57, 58, 59, 65, 66, 67, 68, 70, 74, 76, 79, 80, 82, 84, L1, L5). Changes in technology. "Changes in the regulations or technology are not so rapid that a 3­ year review period is required, especially for small facilities which have storage capacities of only several thousand gallons." (14) Cost. Because his facility required few alterations and is already in compliance, "the need for a review is minimal at best." (4) "Implementation of the proposed five year review schedule would save time and money by reducing a facility's recordkeeping burden." (5) Other amendments. "...( A) mendments to a facility's SPCC Plan are far more likely to be initiated due to changes in facility design, construction, operation, or maintenance than by periodic evaluation of the plan; the existing requirement to amend the plan following such changes, coupled with a periodic review at five year intervals, should therefore continue to provide adequate protection against discharges." (46) Reduced recordkeeping. The proposal would reduce the record keeping burden for facilities subject to the rule while causing no additional harm to the environment because the SPCC plans must be amended when a change in 44 facility design or operation occurs. (10, 14, 17, 22, 27, 28, 32, 42, 46, 55, 74, 79, L1) "This action would alleviate an unnecessary burden for industry while concentrating the agency's efforts for the most environmental benefit. In many medium­ sized trucking facilities, one full­ time position is required to properly maintain environmental records, and for that reason we would urge the agency to finalize this change. " (42) Response cycle coordination. Supports the proposed change because the five year review cycle could then be coordinated with other permits and response plans that are also on 5­ year review cycles. (14, 28, 34, 74) "...( M) any facilities have both SPCC and OPA response plans. Having a five­ year renewal period for both of these related plans will make coordination between the plans much easier. As part of this same rulemaking, EPA is allowing the preparation of combined SPCC, OPA and/ or state response plans. Having a consistent renewal period between at least the SPCC and OPA plans will help this coordination effort." (74) Tank warranties. "Most current tank manufacturers warranty their fuel storage tanks from 1 to 30 years with 20 years being the typical warranty. Therefore, the longevity of the warranty should probably be the determining factor on the frequency of review. If a site includes a tank with a one­ year warranty, it should be reviewed annually; if a site includes tanks( s) with a warranty of 30 years, the five­ year benchmark would appear to be a logical frequency." (73) Opposition to proposal. No benefit to operator. "... SPCC plans are revised almost yearly because as production decreases, the properties are sold or combined with other facilities. Lengthening the review period is no benefit to the operator." (8) No changes. Questions "... the benefit to either the environment or public health to be gained by reviewing the SPCC Plan on any schedule for facilities where no changes are made, or are anticipated to be made, to "... facility design, construction, operation or maintenance..." that might affect its potential to discharge oil. Suggests that we should amend the rule to require periodic reviews only when such aforementioned changes are made. (2) Asks us to "... clarify whether the certification referenced in proposed Section 112.5 (b) addresses the circumstance in which a Plan is reviewed and evaluated but does not require revision. If the Plan is revised, it will be certified by a Professional Engineer pursuant to Section 112.3 (d) and a separate certification that the review and evaluation has taken place would be redundant. The final rule should avoid redundant certifications." (3) The proposed certification language is confusing. (3, 38, 47, 51, 60, 61, 65) 45 Personnel turnover. "If the EPA is serious about ensuring, and not just having something to hit O/ O over the head with if there is a spill, then the time frame for reviews should be shortened, not lengthened. Some of these guys aren't even at the same plant for two years or more." (40) Reduced maintenance. "...( C) hanging the review period from 3 to 5 years may lower the level of facility `maintenance' of the SPCC plan. This is particularly true in the absence of any information about requirements for a facility to ensure personnel are familiar with planning goals and proposed response actions and to address personnel rotations." (72) Completion of review. Support for proposal. (46, 67, 84) "...( T) he proposal to require an owner or operator to certify completion of the review and evaluation in order to provide written proof that the operator has complied with the rule. We believe that prudent operators will document such reviews even without a specific requirement to do so, since it is difficult to prove compliance otherwise." (46) Opposition to proposal. (8, 14, 30, 42, 80, L4, L5). Negative declarations. "We recommend that regulations that require `negative declarations' or certifications of non­ applicability be eliminated. Such certifications are unnecessary record keeping and their absence from facility files may be considered non­ compliance." (L4) No environmental benefit. "Our experience with the SPCC sent to the RA as the result of a spill is the RA staff is overwhelmed by the volume of work so there is not even an acknowledgment of the plan. A certificate sent to the RA will add to the paperwork burden and not improve environmental protection. Further, increasing the SPCC burden will cause small operators to discontinue preparing and updating plans, so the current working system will deteriorate." (8) Certification would only "... add another layer of paperwork to the plan that would do nothing to prevent or clean up contamination. A quick assessment of some of our member's practices indicates that the plans are dated as of each (currently) triennial review and during any updates to the plan that occur because of physical changes to the facility. The date indicates the last time the plan was reviewed for accuracy. ATA believes that this practice should suffice instead of a separate statement." (42) Certification would only add to the recordkeeping burden and would have no apparent positive effects on the environment. (30, 80, L5) 46 Unnecessary. Certification is unnecessary because "... the 5­ year review will result in some modification or amendment of the SPCC Plan, and it will be apparent that a review and evaluation were made. Since the entire plan must be certified in accordance with 40 CFR 112.3( d), it is unnecessarily burdensome and redundant to certify the review and evaluation. The Agency may wish to recommend that a log sheet be added as an appendix to each plan to document the date of the five­ year review and evaluation and to record the names of the persons responsible for the review." (14) Copy to RA. We should consider a requirement for a copy of the certification to be forwarded to the Regional Administrator. (84) We should not require a copy to the RA. (67) PE certification instead. "...( C) ertification should not be required at the owner/ operator level (e. g., plant manager). Environmental engineers at our facilities review and update SPCC plans on a regular basis and maintain documentation of the reviews. GM believes that certification at this level is sufficient, as the facility­ level engineers are most familiar with the plans and are responsible for implementation." (51) PE or company staff. Either company staff or a professional engineer should be allowed to perform certification. (3, 47, 61, 65) "( S) elf review would be adequate to determine if new features or changes have appeared in a facility which trigger revision of the Plan." (3) Requests confirmation to his understanding of the proposal. (38) Requests clarification regarding who is eligible to sign the proposed certification statement. Supports the idea that a responsible individual, other than a Professional Engineer, should be allowed to certify that a Plan has been reviewed and updated. (47, 51, 60, 61, 65) Response: Support for proposal. We appreciate commenter support. Completion of review. We disagree that documentation of completion of review has no environmental benefit. Its benefit lies in the fact that it shows that someone reviewed the Plan to determine if better technology would benefit the facility and the Plan is current. Documentation of completion of review is necessary whether or not any amendments are necessary in order to clearly show that the review was done. Mere dating of the Plan or of an amendment does not show that you performed the required review. Documentation of completion of review is a function of the owner or operator, whereas certification of any resulting technical amendment is a function of the PE. We disagree that documentation of completion should be forwarded to the Regional Administrator because it would increase the information collection burden without an environmental benefit. It is sufficient that the review be done. When the Regional 47 Administrator wishes to verify completion of review, he may do so during an on­ site inspection. Calculation of time between reviews. The change in the rule from three­ year to fiveyear reviews requires some explanation as to when a review must be conducted. For example, a facility became subject to the rule on January 1, 1990. The first three­ year review should have been conducted by January 1, 1993, the second by January 1, 1996, and the third by January 1, 1999. The next review must be conducted by January 1, 2004, due to the rule change. In other words, an existing facility must complete the review within 5 years of the date the last review must have been completed. A facility becoming operable on or after the effective date of the rule will begin a five­ year cycle at the date it becomes subject to part 112. Editorial change. We have changed the word "certification" to a requirement to document completion of the review to avoid the legal effect a certification may have. The intent of the certification proposal was merely to show that an owner or operator performed a review of the Plan every five years. 62 FR 63814, December 2, 1997. A false documentation of completion of review of the Plan is a deficiency in the Plan and may be cited as a violation of these rules. Five­ year review. We agree that a five­ year review period will make coordination of review of related plans, such as facility response plans required by part 112, easier. We disagree that a five­ year review period will lead to reduced maintenance or increased environmental harm. Amendment of a Plan will still be necessary when a material change is made affecting the facility's potential to discharge oil, perhaps after certain discharges as required by the RA under §112.4( a), and perhaps after on­ site review of a Plan (see §112.4( d)). Plus the Plan must be implemented at all times. These opportunities ensure that Plans will be current. We also disagree that the length of the tank warranty should be the determining factor for a technological review. Technology changes enough within a five­ year period to warrant required review within such time period whether or not other changes occur. Amendments other than the fiveyear review amendments may not be based on the need to learn of improved technology. Those amendments might result from deficiencies in the Plan, on the need to make repairs, or to remedy the cause of a discharge. Changes of personnel Changes of personnel at a facility do not affect the responsibility to perform the requirements of this section. How to document completion of review. You must add documentation of completion of review either at the beginning or the end of the Plan, or maintain such documentation in a log book appended to the Plan or other appendix to the Plan. You may document completion in one of two ways. If amendment of the Plan is necessary, then you must state as much, and that review is complete. This statement is necessary because Plan 48 amendments may result either from five­ year review or from material changes at the facility affecting its potential for discharge, or from on­ site review of the Plan. There is no way to know which circumstance causes the amendment without some explanation. If no amendments are necessary, you must document completion of review by merely signing a statement that you have completed the review and no amendments are necessary. You may use the words suggested in the rule to document completion, or make any similar statement to the same effect. Time line for amendment implementation. We agree with commenters (see comments on proposed §112.5( a)) that the preparation and implementation of Plan amendments require more time than proposed. The same rationale applies to the preparation and implementation of amendments required due to five­ year reviews. Therefore, we will require adherence to the time lines laid down in §112.5( b) for amendments. Currently, §112.5( b) requires that Plan amendments be prepared within six months. It is silent as to timelines for implementation. Therefore, we have revised the rule to clarify that amendments must be implemented as soon as possible, but within the next six months. This is the current standard for implementation of certain other amendments. See, for example, §§ 112.3( a) and 112.4( e). We note that §112.3( f) allows you to request an extension of time to prepare and implement an amendment. Who documents review. The owner or operator of the facility, or a person at a management level with sufficient authority to commit the necessary resources, must document completion of review. 49 8. Use of Business Records ­ §§ 112.7( e), 112.8( c)( 3)( iv), and 112.9( b)( 1) Background: In 1997, we proposed to amend §112.7( e)( 8) (redesignated as §112.7( e) in the final rule) to provide that records of inspections maintained pursuant to usual and customary business practices would suffice for purposes of the rule. We also proposed to amend two particular sections (current §§ 112.7( e)( 2)( iii)( D) and 112.7( e)( 2)( vi). These written procedures and a record of inspections, signed by the appropriate supervisor or inspector, must be maintained for three years. Section 112.7( e)( 2)( vi) of the current rule (redesignated as §112.8( c)( 6) of the final rule) requires periodic integrity testing of aboveground tanks, taking into account tank design and using such techniques as hydrostatic testing, visual inspection, or a system of non­ destructive shell thickness testing. It also requires the maintenance of comparison records. In 1997, we proposed to amend §112.7( e)( 2)( vi) to provide that usual and customary business records would suffice to meet the record keeping requirements of the section. Current §112.7( e)( 1) authorizes the drainage of rainwater from a diked area into a storm drain or an effluent discharge that empties into an open water course, lake, or pond, and bypasses the in­ plant treatment system if four conditions are met (see §112.7( e)( 1)( i)­( iv)). In 1997, we proposed to amend §112.7( e)( 2)( iii)( D) (redesignated in the new rule as §112.8( c)( 3)) to allow the use of records recording stormwater bypass events kept under a National Pollutant Discharge Elimination System (NPDES) permit. In the NPDES regulations, "bypass" is defined to mean the "intentional diversion of waste streams from any portion of a treatment facility" (40 CFR 122.41( m)( 1)( I)). The NPDES regulations set forth conditions that all NPDES permits must contain (40 CFR 122.21). One of these "standard conditions" allows for excusable bypasses under certain conditions (40 CFR 122.41( m)( 2)­( 4)). Specifically, 40 CFR 122.41( m)( 3) and 40 CFR 122.41( j)( 2) require that the NPDES permittee provide notice of the bypass event and maintain records of all such bypass events for at least three years from the date of report, respectively. These NPDES permit conditions for notification and record keeping serve the same objective as the SPCC rule requirement in §112.3( c)( 3), and the documentation is therefore acceptable to satisfy the SPCC requirement. Comments: Support for proposal. "Reynolds supports EPA's proposal to amend 40 CFR 112.7( e)( 8) to allow the use of customary business records, such as those maintained pursuant to API standards 653 and 2610, to satisfy recordkeeping and inspection requirements. Reynolds believes that the Agency has taken a sound approach in proposing streamlined reporting/ recordkeeping requirements for this important program." (10, 14, 17, 21, 28, 37, 42, 55, 56, 57, 60, 76, 80, 82, 84, L1, and L5) Support for final §112.8( c)( 3)). (30, 41, 42, 52, 57, 67, 76, 80, L5) 50 Confluence between API standards and CWA requirements. "Current regulations require that aboveground tanks be periodically inspected for signs of damage or deterioration that could cause a spill or leak. API Standard 653 is considered the predominant standard for aboveground tank inspection and API Standard 2610 concerns recordkeeping for inspections and preventive maintenance. CWA recordkeeping regulations require much the same information as the API Standards provide, therefore a company with records resulting from following the two API Standards already has the information required under the CWA." (42) Cost, duplication. The proposed rule would eliminate the need for facilities to keep duplicate records. (37, 56, 57, 80, L5) The proposal would help larger facilities with both SPCC plan and FRP obligations or a discharge permit for a wastewater treatment plant. (17) The proposed change would provide some cost savings through the elimination of redundant inspections. (21) Opposition to proposal. API records inapplicable. "... API standards are not applied to Exploration and Production [E& P] tanks. The majority of E& P tanks are either bolted or welded steel tanks. Some old fields still use redwood stave tanks." (7) "Typically, E& P tanks are 200 to 1000 bbl capacity. They can be inspected under API Standard 653, however, that is not done since in old fields, the cost could not be sustained. The economic life of the field would be shortened by at least 3 years. Additionally, there is no need to make such a rigorous inspection since E& P tanks seldom sustain catastrophic failures. Most oil spills from E& P tanks are the result of storm damage or human error. Spending precious funds on wasteful inspections simply deprives the public of domestic fuel and adds to the quantity transported by ship (which are much more prone to spills)." (8) API Standards 653, 2610, 620 and 650 are "... voluntary standards and many of the records discussed concerning those standards are not commonly kept by smaller oil and gas companies. To remedy this problem, we suggest that those requirements be changed to include the phrase, `when available'." (26) No consequence. "I am aware of no requirement in Missouri nor of any industry in Missouri which reports discharge of stormwaters from secondary containment enclosure. This provision, therefore, is of no consequence in Missouri." (7) 51 Redundancy. "GLCC appreciates EPA recognizing the redundancy of the SPCC requirements with current NPDES requirements." (56) Form of records. API and other voluntary standards. "...( A) note or comment should follow 40 CFR §112.7( e)( 8) stating that usual and customary business records may include those maintained pursuant to appropriate API and/ or other voluntary consensus standards. The inclusion of such guidance will make it easier, in years to come, for regulated entities to understand the intent of the Agency with respect to the recordkeeping requirements without the need to locate a copy of this Federal Register notice. Ash Grove also believes that the placement of such guidance in the rule itself will better meet the apparent intent of the National Technology Transfer Advancement Act (as described on page 63818 of the Proposed Rule), whether or not the Act applies in this instance." (15) NPDES records. We should allow the use of records maintained pursuant to NPDES permits to suffice for the requirements in §112.7( e)( 8). (4, 21, 30, 42, 56, 57, 67, 80, L5) RCRA/ SPCC confluence. "( C) omparison of the requirements under sections 112 and (40 CFR) 264/ 265 indicate that there is little difference between the requirements of these sections." (81) UL Standards. Re integrity testing "Therefore, the methods of testing can be easily determined by referencing the method used by Underwriters Laboratories to validate both the primary and secondary containments of each assembly. The use of: pneumatic (pressure), hydrostatic, vacuum, sonar, tracer gas, any combination of two of the aforementioned methodologies or another method as determined by either the listing authority or authority­ having jurisdiction will be considered acceptable for purposes of this section." (73) "... In addition to the aforementioned Standards, please accept those standards for the storage of Flammable and Combustible Liquids developed by Underwriters Laboratories, Inc. (UL) and Underwriters Laboratories of Canada. These will include standards for construction, design, performance, testing, maintenance and all facets of storage of materials in accordance with the Oil Pollution Act, including UL Standard 142 for Bare Steel Aboveground Tanks, UL Subject 2080 for Fire­ Resistant Tanks, UL Standard 2085 for Protected Aboveground Storage Tanks and UL Subject 2245 for At/ Below­ Grade Aboveground Storage Tanks (Vaults). The Agency could easily canvass this proposal by participating in the UL IAG forum previously mentioned. Please note that inclusion of these Standards and Subjects will include the use of an 52 auditing mechanism that might conceivably reduce the information­ collection burden/ historical difficulties for the Agency." (73) "In addition, a new controversy relative to the merits of a UL Subject 2244, Systems Listing wherein both the storage tank and all its accessories are evaluated and certified in the form of a listing label would appear to be logically worth consideration by the US EPA. While regulatory authorities traditionally support the Systems Listing and Industry opposes the Systems Listing, perhaps the involvement of US EPA can Provide a significant input to resolving this new factor in evaluating fuel storage." (73) Use optional. "As long as the tanks and secondary containments are inspected and maintained, the format used to document these events is not important. Utilizing an existing document, such a departmental maintenance log would be more than adequate to demonstrate that the facility has compiled with the regulatory obligations. Furthermore, using an established plant procedure will be less confusing for the individuals involved and more readily retrievable when requested." (38) "...( I) t should be clarified that facilities are not required to use the API Standards listed in the preamble. Facilities should be allowed to continue to use a format specifically designed for documenting SPCC requirements." (51) FRP record retention period. "Since the record retention provision pertaining to Facility Response Plans (FRP) is contained in the model included in Appendix F (Section 1. 8. 1) and not in Section 112.20 itself, it is not clear whether the five year reference is a guideline or a requirement. Even assuming that the five year reference is a requirement, it is unclear as to why FRP records should be retained for a period two years longer than the SPCC records. Retention of inspection records allows EPA to review a facility's past records. As such, this retention period should not be a function of the size of the facility. The same retention period should apply to all facilities. TVA, therefore, recommends that the proposed rule clarify whether the records retention requirement is intended to apply to records generated as a result of inspections required in FRPs. If so, a three year retention period should apply to those records generated as a result of facility self­ inspections specified in Section 1. 8. 1 of Appendix F." (21) Maintenance with Plan. Criticizes the provision that records must be made a part of the Plan as burdensome and no benefit to the environment. (14, 21, 27, 35, 41, 52, 58, 61, 70, 84) "PM records are much better kept in a special PM notebook, which is often equipment­ specific. It would be awkward and administratively burdensome for a facility, particularly a small facility, to either file the PM report in the SPCC Plan or to reproduce the PM report and physically insert it into the SPCC Plan. It would be far better to simply include in the SPCC Plan a reference to the fact that PM inspections 53 are performed, that they are usual and customary, and include the location of the completed records (e. g., maintenance supervisor's office). This issue is particularly critical for records demonstrating compliance with employee training requirements at 40 CFR 112.7( e)( 10). The best location for such records is in the employee personnel files, not an SPCC Plan." (14) NPDES rules. Seeks clarification on proposed "adoption by reference" of NPDES rules. (23, 29, 31, 43, 47, 60, 61, 70, 83) No SPCC regulation ­ NPDES instead. "AFIA believes an exception should be created for reporting and recording dike bypasses of 112.7( e)( 2)( iii)( D) relating to animal and vegetable oil storage, requiring such reporting and recording only if required by NPDES stormwater permits." (23) No NPDES requirements either. "Release of uncontaminated rainwater from containment areas should not be subject to monitoring and notification requirements of the NPDES program." (29) NPDES rules sometimes inapplicable. "...( T) he NPDES regulations contain requirements which should not apply to SPCC facilities, including the condition that the permittee must provide notice of a bypass event." (43) Receipt and understanding. "...( A) s a matter of usual and customary business records that the owner/ operator of the SPCC Plan/ FRP site be required to sign a document acknowledging receipt and understanding of the appropriate plan. This would indicate that the site had been properly reviewed, the owner/ operator informed and that the liability to maintain and supervise the site had been specifically acknowledged. No cause should be promoted that an SPCC Plan is certified, forwarded to the site and placed on a shelf without review or acknowledgment." (73) Requirement or recommendation. "EPA should clarify in the final rule that references in the preamble to requirements for periodic integrity testing of aboveground tanks and inspections are only voluntary recommendations in the current regulation and are not required. EPA erroneously refers to periodic integrity testing of aboveground tanks and inspections as required activities (see page 63815, middle column under the heading "40 CFR 112.7( e)( 2)( vi) and page 63815, right column under the heading "40 CFR 112.7( e)( 8))." (47, 61, 74) States. "If the states maintain the regulation as it currently stands, it will only negate the Agency's current efforts in these proposed revisions to the requirement. The Company is concerned about the regulatory burden this may create if each state maintains the current regulation, or makes the decision to develop more stringent regulations." (48) 54 Usual and customary business records. Requests clarification regarding the definition of "usual and customary business records" as written in the proposed rule. (14, 15, 38, 51, 81) Response: Support for proposal. We appreciate commenter support. Applicability ­ §112.8( c)( 3). This paragraph applies to discharges of rainwater from diked areas that may contain any type of oil, including animal fats and vegetable oils. The only purpose of this paragraph is to offer a recordkeeping option so that you do not have to create a duplicate set of records for SPCC purposes, when adequate records created for NPDES purposes already exist. Applicability ­ §112.9( b)( 1). We believe that this requirement must be applicable to both large and small facilities to help prevent discharges as described in §112.1( b). The risk of such a discharge and the accompanying environmental damage may be devastating whether it comes from a large or small facility. We disagree that the recordkeeping is burdensome. If you are an NPDES permittee, you may use the stormwater drainage records required pursuant to 40 CFR 122.41( j)( 2) and 122.41( m)( 3) for SPCC purposes, thereby reducing the recordkeeping burden. Discharge records necessary ­ §112.8( c)( 3). Only records of discharges "that may be harmful" as described in 40 CFR part 110 are required. A discharge "that may be harmful" includes a discharge that violates applicable water quality standards, or which causes a film or sheen upon or discoloration of the surface of the water or adjoining shorelines or which causes a sludge or emulsion to be deposited beneath the surface of the water or upon adjoining shorelines. Engineering methods ­ §112.9( b)( 1). "Equivalent" measures referenced in the rule might, depending on good engineering practice, include using structures such as stand pipes designed to handle flow­ through conditions at water flood oil production operations, where large volumes of water may be directed to oil storage tanks if water discharge lines on oil­ water separators become plugged. Any alternate measures must provide environmental protection equivalent to the rule requirement. Form of records. Records of inspections and tests required by this rule may be maintained in electronic or any other format which is readily accessible to the facility and to EPA personnel. Usual and customary business records may be those ordinarily used in the industry, including those made under API standards, Underwriters' Laboratories standards, NPDES permits, a facility's QS­ 9000 or ISO­ 14000 system, or any other format acceptable to the Regional Administrator. If you choose to use records associated with compliance with industry standards, such as Underwriters' Laboratories standards, you must closely review the inspection, testing, and record keeping requirements of this rule to ensure that any records kept in accordance with 55 industry standards meets the intent of the rule. Some standards have limited record keeping requirements and may only address a particular aspect of container fabrication, installation, inspection, and operation and maintenance. The intent of the rule is that you will not have to maintain duplicate sets of records when one set has already been prepared under industry or regulatory purposes that also fully suffices for SPCC purposes. The use of these alternative record formats is optional; you are not required to use them, but you may use them. FRP record retention period. We recognize that the record retention periods will differ under the revised rule for SPCC facilities as opposed to response facilities. We may consider a uniform record retention period in the future for all types of facilities. Maintenance with Plan. We agree with commenters that it is not necessary to maintain records as part of the Plan. Therefore, today's rule allows "keeping" of the records "with" the Plan, but not as part of it. In the current rule, such records "should be made part of the SPCC Plan...." 40 CFR 112.7( e)( 8). Because you continually update these records, this change will eliminate the need to amend your Plan each time you remove old records and add new ones. You still retain the option of making these records a part of the Plan if you choose. NPDES rules. We are not adopting the NPDES rules for SPCC purposes, but are only offering an alternative for recordkeeping. The intent of the rule is that you may, if you choose, use the NPDES stormwater discharge records in lieu of records specifically created for SPCC purposes. We are not incorporating the NPDES requirements into our rules by reference. Receipt and understanding. The owner or operator of a facility already is responsible for Plan preparation and implementation. The Plan must have the full approval of management at a level of authority to commit the necessary resources. Such approval must be documented in the Plan by signature of the owner or operator. Records required. The rule permits use of usual and customary business records, and covers all of the inspections and tests required by this part as well as any ancillary records. "Inspections and tests" include not only inspections and tests, but schedules, evaluations, examinations, descriptions, and similar activities required by this part. After publication of this rule, we will list all of the inspections and tests required by part 112 on our website (www. epa. gov/ oilspill). The applicability of each inspection and test will depend on the exercise of good engineering practice, because not every one will be applicable to every facility. Requirement or recommendation. We have always interpreted and enforced our rules as mandatory requirements. 56 States. Both the States and EPA have authority to regulate containers storing or using oil. Some States have exercised that authority while others have not. We do not preempt State rules, and defer to State law that is more stringent than part 112. Time period. We agree with commenters that maintenance of records for three years is sufficient for SPCC purposes, since that period will allow for meaningful comparisons of inspections and tests taken. We note, however, that certain industry standards, for example API Standards 570 and 653, may specify record maintenance for more than three years. Usual and customary business records. Usual and customary business records are those records normally used in commerce. 57 9. Capacity of Facilities Storing Process Water/ Wastewater for Response Plan Purposes ­ proposed §112.20( f)( 4) Background: In 1997, we proposed to add a new paragraph to §112.20( f) to provide a method for facility response plan purposes to calculate the oil storage capacity of storage containers storing a mixture of process water/ wastewater with 10% or less of oil. This proposal for certain systems that treat process water/ wastewater would be applicable at certain facilities required to prepare a facility response plan. It would have no effect on facilities required to prepare response plans because they transfer oil over water and have a total oil storage capacity greater than or equal to 42,000 gallons. Likewise, the proposal would have no effect on the method of calculating capacity for purposes of SPCC Plans. Under the proposal, we would not count the entire capacity of process water/ wastewater containers with 10% or less of oil in the capacity calculation to determine whether a facility must prepare a facility response plan. We only would count the oil portion of that process water/ wastewater contained in §112.20( f)( 2), and therefore response planning is not necessary. Today, we are withdrawing the proposal because it is no longer necessary. It is unnecessary because we have exempted from part 112 any facility or part thereof (except at oil production, oil recovery, and oil recycling facilities) used exclusively for wastewater treatment and not to satisfy any requirement of part 112. See the discussion under §112.1( d)( 6). The exemption in §112.1( d)( 6) applies to the types of facilities treating wastewater that would have been allowed to calculate a reduced storage capacity if the percentage of oil in the mixture were 10 percent or less. 58 10. Facility Response Plan Format ­ §112.20( h) Background: In 1997, we proposed to amend the requirements for formatting of a facility response plan to clarify that an Integrated Contingency Plan (ICP) or other plan format acceptable to the Regional Administrator is allowable to serve as a facility response plan if it meets all facility response plan requirements. Our intent was to track language in the SPCC rule allowing the Regional Administrator similar authority to accept differing formats for SPCC Plans. However, the Regional Administrator already has the authority to accept differing formats for response plans, and the existing facility response plan requirements already provide for cross­ referencing. See §112.20( h). Therefore, new rule language was unnecessary, and the proposal tracked current language. Today, we have made only a minor editorial change in rule language. Comments: Support for proposal. "Similarly we support the Agency's proposal to allow the ICP as an FRP." (14, 41, 45, 47, 51, 56, 58, 61, 73). Any format. Any equivalent format, not just the ICP format, should be an acceptable format for a FRP "... so long as the alternative format meets all regulatory requirements and includes an appropriate cross­ reference." (14, 41, 47, 51, 58, 61) ICP format beneficial. This inclusion would simplify compliance with the FRP rules because it would "consolidate plans and eliminate duplication." (41) "...( P) reparation and use of an ICP or other format would not reduce the information collection burden of the FRP rule, but would simplify compliance with multiple applicable statutes and rules." (45) Supports "... EPA's intent for a FRP that is equivalent to the existing requirements without requiring approval from the EPA Regional Administrator." (47, 58, 61) The use of the ICP as an acceptable format for a FRP would reduce the burden on industry while maintaining the same level of environmental protection. (65) No change. The proposed rule language did not include any changes. (14, 21, 41, 47, 58, 61) Acceptable formats. "Because of earlier jurisdictional interpretations by EPA regional offices, EPA should clarify that the use of such an equivalent format for the SPCC Plan or FRP does not require the approval of the EPA Regional Administrator." (47, 52, 58, 61) Editorial suggestion. "A response plan shall follow the format of the model facilityspecific response plan included in Appendix F to this part, unless (i) an equivalent response plan has been prepared to meet state or other Federal requirements, or (ii) an 59 ICP has been prepared in accordance with the notice published at 61 Fed. Reg. 28642, June 5, 1996." (21) PE certification. Suggests revised second sentence in 40 CFR 112.3( d) to allow a PE "to more easily certify the SPCC portion of an Integrated Contingency Plan (ICP)." With these changes an ICP will now "... discuss the preventive structures such as tanks, berms, containments, and process systems of the SPCC plan, which a PE can easily review, quantify, and certify in accordance with their license, as well as the imprecise response theory for oil and hazardous materials releases, fire fighting and other emergency plans which are not within the scope of a PE certification." (63) "As previously submitted relative to SPCC Plans, SPC Corp suggests that Facility Response Plans may be prepared by qualified individuals such as tank/ equipment representatives, licensed technicians, personnel with significant experience in composition of SPCC and/ or FRP Plans who submit their draft plans to independent PE's for certification in order to reduce the financial burden to the owner/ operator. The existing interpretation often requires a PE to physically inspect the site to the extent that certification fees can outweigh the purchase price of innovative and safe onsite equipment. Certainly the Agency does not want to see these "soft costs" discourage the implementation of a secure and safe sight." (73) Response: Acceptable formats. It is not necessary for the rule to mention the ICP or any other format specifically because the rule already allows the Regional Administrator flexibility to accept any format that meets all Federal requirements. Any format that contains all the required elements of a response plan would be presumptively acceptable. See §112.20( h). You may use the ICP, a State response plan, or other format acceptable to the Regional Administrator, at your option. We do not require use of any alternative format, but merely give you the option to do so. Editorial suggestion. We added the words "acceptable to the Regional Administrator" in the first sentence after the words "response plan." No change. The commenters are correct that the proposed rule is identical to the current rule. The current rule allows the submission of an "equivalent response plan that has been prepared to meet State or other Federal requirements." Partially acceptable formats. You have the option to integrate any or all parts of an ICP with your response plan. This gives you flexibility in formatting. Similar to SPCC Plans, the Regional Administrator may accept partial use of alternative formats. PE certification. PE certification is only required for the SPCC portion of any ICP. 60 11. Supporting Analyses Background: For the 1997 proposed rule, we performed supporting regulatory analyses in accordance with Executive Order 12866, the Regulatory Flexibility Act, the Paperwork Reduction Act, the Edible Oil Regulatory Reform Act, the Unfunded Mandates Reform Act, and the National Technology Transfer and Advancement Act. Comments: Costs. Operates and maintains numerous aboveground storage tanks, of which "... approximately 20% have a storage capacity greater than 660 gallons, but less than 1, 320 gallons. The majority of U S WEST facilities only contain one AST at any particular site. When these tanks are constructed, they often remain intact for many years without a construction disturbance or a need of any repair. The average cost to the Company to develop an SPCC plan for these tanks has been approximately $2,500. U S WEST corporate policy also makes responsible environmental management a company priority. In doing so, the Company frequently inspects all tanks during operations reviews and audits." (48) Small facilities. Costs do not vary significantly by size of facility. (31) Questions the impact of the proposed rules on small entities. (7, 52) We certified that the October 22, 1991 and the December 2, 1997 proposed rulemakings would not have a significant adverse impact on a substantial number of small entities and that no regulatory flexibility analysis was done. (7) Disagreements with economic analyses. Electrical equipment facilities. EPA does not intend to regulate substations because "... EPA has not included substations in its calculations of burden imposed by SPCC regulations for the 1991, 1996, as well as the December 19, 1997 submittal to the Office of Management and Budget." (57) We must recalculate the costs associated with compliance because we have significantly underestimated the number of electric utility facilities that would be subject to the rules if their scope included electrical equipment. (70) Information collection ­ FRP rule. "( T) he Agency has previously estimated that it requires approximately 118 hours for facility personnel in a "large, consumption facility" to comply with the annual subsequent year reporting and recordkeeping requirements of the FRP rule after adjusting for compliance with other Federal and State regulations. CasChem believes this estimate to be low. CasChem is not a "large, consumption facility". For CasChem, the FRP development and approval process has been frustrating. Over the years the facility has developed a comprehensive DPCC/ SPCC/ DCR. BMP Plan to incorporate New Jersey­ specific and federal requirements. The Plan has been developed and maintained primarily by one environmental engineer with heavy reliance on outside consulting 61 expertise. Our current FRP is being revised at this time to improve formatting and to provide more details. This effort alone will take more than 118 hours to complete at a cost of more than $50,000. We anticipate future annual estimates for FRP maintenance to require more than 118 hours." (84) Requests for Differentiation. Electrical equipment facilities. "The data presented in this report suggests that it would perhaps be more appropriate to consider mineral oil dielectric fluids as more akin to food grade oils rather than to petroleum­ based fuels. This argument is made based on comparisons of PAH, metals and BTEX concentrations, as well as overall toxic effects exhibited by the two classes of materials. Consequently, a release of dielectric fluid to the environment does not have the same types of short­ term or long­ term impacts as less refined fuel­ type oils. This claim has been substantiated through observations documented during and after the response action to the August 1993 dielectric fluid release at Entergy's Roland Road substation near Little Rock, Arkansas­­ one of the two incidents alluded to in the introduction to these comments." (18) Requests for Use of Other Sources in Analyses. Animal fats and vegetable oils. "It is important for EPA to recognize animal fats and vegetable oil spills can not reasonably be expected to cause substantial harm to the environment. Documented spill records indicate that animal fats and vegetable oils account for only 0. 4 percent of the oil spill incidents in U. S. waters, and only 0. 02 percent of those involved releases of over 1,000 gallons. EPA must agree the animal fats and vegetable oils industry not only has an excellent safety record, but is committed to prevention of oil spills and protecting the environment. ... ...( T) he feed industry, SIC code 2048, is regulated by EPA's stormwater runoff regulation. Feed industry facilities already administer management and engineering controls for the reduction and prevention of pollutant loading in storm water. Pollution prevention plans detail spill prevention, clean up, housekeeping and maintenance programs to safeguard stormwater becoming loaded with any pollutants from the grounds of the facility." (23) Costs ­ electrical equipment facilities. Has approximately 3, 500 transmission and distribution electrical equipment installations potentially subject to the 40 CFR Part 112 rule. "Insofar as cost of compliance, generation of site­ specific oil spill prevention control and countermeasure (SPCC) plans for these facilities has been estimated to average $4000 per facility, for a total cost for plan generation of approximately $14 million. In addition, imposing the requirement for secondary containment on Entergy's electrical equipment installations would require expenditures estimated at $30,000 per installation, for a total cost in excess of 62 $100 million. Costs of plan maintenance, including the current triennial evaluation and possible professional engineer recertification of the site­ specific plans, are uncertain, but would possibly approach $2 million per year. In light of the extremely low spill rates occurring from oil­ filled electrical devices at Entergy facilities; such costs, which would ultimately be shouldered by our customers, are unjustified. It should be noted that for the time period encompassing years 1993 through 1997, oil releases at Entergy electrical substations totaled seventy incidents. Discounting spills of less than one hundred gallons, this number drops to twenty­ five. Of these releases, two incidents impacted waters of the United States. These numbers translate to two occurrences per 17, 500 facility­ years." (18) Dielectric fluids. We should "... consider information contained within the Electric Power Research lnstitute's Mineral Insulation Oil Characterization Report. This document was submitted with the USWAG comments. While Entergy is aware of the Agency's recently published decision document regarding regulation of vegetable oils and animal fats under the Part 112 rule, this technical information should not be discounted when evaluating what constitutes a prudent course of action for addressing releases of mineral oil dielectric fluid. The EPRI study provides an in­ depth comparison of the chemical/ physical characteristics of mineral oil­ based dielectric fluids compared with gasoline and diesel oil." (18) Our recognition that "... electrical equipment is fundamentally different from other oil­ storage equipment is an important step in crafting regulations appropriate to this area." (65) Response: Costs. We recognize that electrical equipment is not bulk storage and do not regulate it as such. However, electrical equipment remains subject to the general requirements of the rule, including secondary containment. If secondary containment is not practicable, you may instead provide a contingency plan. The final rule also allows for equivalent prevention plans, which might include a multi­ facility plan, that will enable certain firms to economize on the preparation of plans for similar types of facilities. We are also no longer going to regulate facilities having a total oil storage capacity of 1, 320 gallons or less, but that have a single aboveground container in excess of 660 gallons. We will have a regulatory threshold of greater than 1,320 gallons instead. Nor will we regulate containers smaller than 55 gallons. Therefore, the compliance burden for the smallest facilities will end. In summary, however, we estimate the burden of the rule using a model facility approach, which differentiates compliance costs by facility size. We recognize that some facilities may actually incur higher costs, while others incur lower costs, than estimated for each model facility. We did perform a small business analysis for our 1991 proposed rulemaking, which was included in our economic impact analysis of the proposed rulemaking (January 1991). The commenter is correct, though, that we did not perform a formal regulatory flexibility analysis for our 1997 proposed 63 rulemaking because the proposed revisions were deregulatory in nature and posed no significant impact on a substantial number of small entities. Electrical equipment facilities. Substations are included in the scope of the SPCC rule, and we have included them in our burden calculations for the final rule. Our 1996 SPCC renewal ICR adjusted upwards the burden estimate for utilities for the number of SPCCregulated electrical equipment based on similar comments received during that renewal period. Information collection ­ FRP rule. We acknowledge the final comment concerning the information collection burden for response facilities, but it is outside the scope of this final rulemaking because the proposed revision to §112.20( f) has been withdrawn. We will consider your comment in future reviews of the Information Collection Request for the FRP rule. Requests for Differentiation. Because at the present time EPA has not proposed differentiated requirements for public notice and comment, the requirements for facilities storing or using all classes of oil will remain the same. We have, however, established separate rule sections for facilities storing animal fats and vegetable oils. We also have published an advance notice of proposed rulemaking seeking comments on how we might differentiate requirements for facilities storing or using the various classes of oil. 64 FR 17227, April 8, 1999. After considering these comments, if there is adequate justification for differentiation, we will propose a rule. Requests for Use of Other Sources in Analyses Dielectric fluids. We have reviewed the document mentioned. We will also consider it in our upcoming proposed rule to consider differentiated requirements for facilities storing or using different types of oils. 64 12. Miscellaneous Comments Applicability. We should provide guidance to clarify the applicability of SPCC plan regulations at 40 CFR 112.3( a). "...( I) n relation to `due to their location, could reasonably be expected to discharge oil in harmful quantities into navigable waters or adjoining shore lines. ' What does `due to location' mean? What does "reasonably expected" mean?" (L4) Applicable items. Section 112.7, "Guidelines for the preparation and implementation of a Spill Prevention Control and Countermeasure Plan," should read as follows: "The complete SPCC plan shall follow the sequence outline below, but listing only applicable items, unless it is in another format acceptable to the Regional Administrator, such as described in 112.2, and include a discussion of the facility's conformance with the appropriate guidelines listed." "This change is intended to clarify that SPCC plans are only required to contain a citation of all 112.7 items that are applicable, rather than list all non­ applicable items too and explain why. This will simplify SPCC plan preparation and avoid violation notices about missing non­ applicable items. (44) Burden reduction. "In the supplemental December 1997 proposal, EPA has done so in certain respects by proposing a few amendments to the SPCC and OPA rules. While these efforts are certainly laudatory, they fail to address the basic problem with the SPCC program, which is the Agency's attempt to impose a "one­ size­ fits­ all" regulatory program on facilities that differ by orders of magnitude in size, characteristics, method of operation, and risk to the environment." (31) "Such burdens can be reduced a lot more by having the SPCC Plan actually written as a plan.... Simply put, a Plan should tell someone how to do something, not how it is being done or what they should consider doing or what they are not doing!" (40) Certification by other environmental professionals. We should accept other environmental professionals for Plan certification. (33, 44, 62, 63, 64, 73) "The Environmental Professional who provides certification for review of and amendment to the SPCC Plan should be familiar with 40 CFR 112, the facility, and the facility's operations. The DFW Airport Board anticipates that the Environmental Professional responsible for implementing and maintaining the SWPPP would also be responsible for implementing and maintaining the SPCC Plan." (33) "...( I) t is also timely to consider the addition of another professional group (other than Professional Engineers) to sign­ off on the appropriate documentation. Specifically, we are proposing the new provisions state the inclusion of either a Professional Engineer or a Master­ Level Certified Hazardous Materials Manager as authorized signators." The commenter continued to describe the qualifications of a Master­ Level CHMM as well as point out that other Federal agencies, such as the DOE, DOT, Corps of Engineers and branches of the DOD, that have recognized the benefits of CHMMs. (62) Endorses the eligibility of other qualified individuals to certify a Plan. If a facility "... does not have a registered professional 65 engineer for a particular state, it must hire one, at some cost, to review the plans prepared by internal, non­ PE staff. Questar believes that this cost is unnecessary since good engineering practice, like best management practices in water pollution control, are not the exclusive province of the engineer. Questar further believes that individuals who are familiar with particular facilities and with the local meteorology, who understand the operations of the facilities and who are familiar with the requirements of 40 CFR 112, can (and should) develop spill prevention plans. The qualification of the PE, while valuable in many other respects, is unnecessary for this pursuit." (64) Suggests that the site preparation of the SPCC plan be expanded to include "... qualified individuals such as representatives of the tank manufacturer, licensed technicians, personnel with significant experience in composition of SPCC or FRP Plans who submit their draft plans to independent PE's for certification in order to reduce the financial burden to the owner/ operator. The existing interpretation often requires a PE to physically inspect the site to the extent that certification fees can outweigh the purchase price of innovative and safe equipment. Certainly the Agency does not want to see these "soft costs" discourage the implementation of a secure and safe site." (73) Completely buried tanks. "Update portions dealing with underground storage tanks as they are now covered by other regulations." (40) "The EPA includes underground storage tank (UST) capacity in the applicability section and the bulk storage tank section of the rule. 40 CFR 112, implemented in 1973, is an above ground storage tank (AST) rule while 40 CFR 280, implemented in 1988, is a UST rule. The newer 40 CFR 280 rule very clearly establishes UST construction, spill prevention, and release detection standards which are more detailed and more stringent than the older SPCC rule. FPC requests the EPA acknowledge the replacement of the UST portions of the SPCC rule by 40 CFR 280 by removing the duplicative and confusing sections of 40 CFR 112, specifically, 40 CFR 112.1( d)( 2)( I), 112.7( e)( 2)( iv), and 112.7( e)( 2)( v) should be deleted." (63) "Delegated" States. We should urge delegated states to change their corresponding regulations to match our regulations so that the benefits of the proposed changes in the SPCC plan can be fully realized. (67) Endorsed comments. API. Supports proposed revisions, refers us to API comments submitted on the 1997 proposal, which proposed additional revisions in regard to underground storage tank thresholds. (24, 50) USWAG. Utility Solid Waste Activities Group (USWAG) member endorses the comments filed on its behalf under separate cover. (35) Supports comments submitted by the USWAG, the Edison Electric Institute, the American Public Power Association, and the National Rural Electric Cooperative Association 66 (collectively, "USWAG"), on the subject proposed rule. Reiterates support for the USWAG comments previously submitted on the 1991 and 1993 SPCC proposals (56 Fed. Reg. 54612 and 58 Fed. Reg. 8824, respectively). (69) FRP applicability. "For Facility Response Plans, require that the Plan identify those locations from which a release can be monitored, and those locations where access to the river can be achieved for the equipment necessary to contain and to recover a release. That way the response people/ contractor knows where to go. These locations should be identified by name, by directions from major streets (so that information can be conveyed by telephone, by map, and by the ETA after a release based on no less than three flow conditions (low flow, typical flow, high­ water flow). I have developed a means to estimate the center­ of­ stream flow rate at any point in time. The width of selected bridges downstream are measured and a chart prepared giving the flow rate based on how long it takes an object to float under the bridge. I recommend 6­ inch pieces of 2 by 4 painted fluorescent orange along with a large flashlight and a watch with a second hand." (40) Recommends that 40 CFR 112.20( e), which requires facilities not otherwise subject to facility response planning regulation to certify non­ applicability, be deleted. (L4) Inspection periods. Asks that "... this section of the regulatory text describe in more specific terms the inspection periods to be once a year. This will aid in the elimination of collapsed AST's in 2 or 3 years after the last integrity testing further reducing the threat or potential of a threat of environmental impact subject to AST's collapsing." (1) Integrity testing. Suggests "1. A maximum interval for testing of tanks, etc. needs to be specified, such as not less than 5 years on tanks 10 years old or older; 2. It needs to be clarified if the visual inspection means an internal inspection; and, 3. It needs to be clarified if these periodic inspections must be conducted by or under the direction of a qualified professional engineer (especially when structural and foundation inspections are a part of the work ­ that is engineering work)." (40) Loading areas. Disagrees with the proposed 40 CFR 112.7( h)( 2). "( V) ery few facilities provide such containment. Most facilities depend on continuous attendance during loading/ unloading and the use of drip pans or buckets to prevent spills of any size at the truck or tank car. Requiring secondary containments for tank car and tank truck loading areas is a very costly requirement especially for small businesses which has very little payback in terms of spill prevention beyond present practices." (7) Points out two situations where the rule provisions on loading areas poses a burden on facilities: (1) An industrial facility has a 1, 500 gallon aboveground storage tank for the collection of used oil generated during equipment maintenance. A 4, 500 gallon single compartment tanker truck comes three times a year to ship the used oil to a recycler. According to U. S. EPA interpretation, the facility would have to provide 4, 500 gallons of 67 containment for a bulk tanker truck for an aboveground tank that is only 1, 500 gallons in volume.; and, (2) An industrial facility has three 500 gallon tanks to provide diesel fuel at different locations around the plant. One 500 gallon tank provides fuel to a diesel pump that is a back­ up system for the plant's fire protection. The other two 500 gallon tanks are used to fuel plant vehicles. Each of the three tanks is filled approximately once or twice each year from a 4, 500 gallon single compartment tanker truck. According to U. S. EPA interpretation, the facility would have to provide 4, 500 gallons of containment in three separate locations for three 500 gallon aboveground tanks. Installation of containment structures for tanker trucks is costly, requires significant space, and typically raises issues of handling collected storm water. The current rules are burdensome for these facilities where small volume transfers occur on an infrequent basis." "A requirement for written procedure regarding loading/ unloading operations could be included in the SPCC Plan in lieu of providing containment for the tanker truck ... Although this method may create additional paperwork, the overall economic burden to the facility is significantly reduced, yet a similar level of environmental protection is provided." (12) "Clarify 112.7( e)( 4) or define "Rack". Most unloading and many loading points are not an actual rack but a coupling outside the tank containment area. Many SPCC Plans [do] not address the potential of a spill from such locations." (40) "Also regarding racks, the use of the largest compartment of the vehicle is reasonable for unloading, but may fall way short for loading considerations ­ the potential spill would be the capacity of the tank. The containment required for both instances should be based on the fact that such operations should be attended and controlled. The secondary containment should be a function of flow rates, time to respond, and the fail­ safe features of the response action." (40) Bulk petroleum loading/ unloading at trucking facilities are considered "in transport" and therefore are under USDOT regulations, not SPCC. Cities January 6, 1998 publication of the List of Regulated Substances and Thresholds for Accidental Release Prevention; Amendments (63 FR 640). Explains that the volume of spills from such unloading operations are small, and compliance under SPCC requirements would involve enormous costs. (42) "...( M) ember cooperatives, in addition to secondary containment for these tanks, are required to install a containment system in loading and unloading areas where there is no catchment basin, treatment facility, or a quick drainage system to handle spills as per 112.7( e)( 4)( ii). This means a concrete spill pad for company­ use tanks such as two­ 1000 gallon tanks must have the capacity to hold whatever the maximum capacity of the largest tank truck compartment (typically 600 gallons). Small tank sites are required to go through all the steps in developing a SPCC plan as would a larger petroleum storage facility. This simply does not make sense and is highly resented by the smaller operators. There needs to be a more simple, less expensive way of doing this for the small operator." (71) 68 More information. "Enforce the Rule you've got! I can't drive 40 miles without seeing tanks without secondary containment. Require the O/ O submit a letter to the EPA stating that they have a SPCC Plan for each facility over the threshold, and state who is the certifying engineer. That list can be checked against registrations of above ground tanks now required by at least some of the states. Also, it is one thing to ignore the rule, another to falsify information." (40) Oil, definition of. We should publish a specific definition of oil to reflect the method of calculating the storage capacity for tanks containing oil/ water mixtures for potential substantial harm facilities. Wants a revised definition in order to "... clarify what types of substances actually qualify as oil under these rules. The current definition is broad and ambiguous. Manufacturing facilities use many kinds of solvents and machining fluids. Many are derived from a petroleum base. Under the current definition, such solvents as napthas, hexane, mineral spirits, toluene and xylene could be considered oil. General Motors believes that this is not the intent of the SPCC rules, and that solvents should not be included in the definition of oil." (51) PE­ related issues. Mandatory requirements, PEs. Concerned that elements of the previous proposed rules for the SPCC Program, such as the 1991 proposed rules, are "... not consistent with this tenor of conciliation and flexibility. E. g., making the guidance in 40 CFR 112.7 mandatory and requiring third party professional engineers for certification is proceeding in a direction opposite to that which the subject proposed rule goes and, we emphasize, opposite to that which we should be going." (14) PE notification. "Require that the certifying PE be notified when a reportable spill occurs, when changes are made to the secondary containment system, when a tank or loading/ unloading point is added, or when a tank is replaced with a larger tank." (40) Secondary containment. Surprised that the revised proposal did not address 40 CFR 112.7( c), which requires secondary containment, including the walls and floor, to be impervious to oil for 72 hours. The associated compliance costs for this proposed requirement well exceed any possible benefit and it would be a detriment. (32) Accumulation of storm water. "Specify what `an accumulation of storm water means'. The 1991 proposed rule noted the 25­ year return, 24­ hour duration storm. This is on the order of 6 to 8 inches of rain at many facilities in the midwest and southeast. Many facilities only have a 12 inch curb and cannot contain more than a 2 or 3 inchrainfallwithout their secondary containment being insufficient for the largest tank." (40) 69 Available secondary containment. "Specify who is to calculate the available containment, the plant operator or the certifying engineer. Plant operators often do not deduct for the footprint of other tanks within the containment, or do not allow for precipitation off of roofs or drainage onto the site. One client installed a new culvert under railroad tracks to triple the containment capacity. The problem was that the product was asphaltic cement that would have to flow through any standing water in the pipes and equalize out before over­ topping the first containment area. Also, the final free­ board was only 1 inch." (40) Double­ walled tanks. " We have recently upgraded the storage tanks at this facility. Each of the four (4) buried tanks has been removed. Each system was more than 20 years old and represented a potential source of contamination to the groundwater. Four new above­ ground double walled storage vaults have been installed with all the extra bells and whistles: leak detection systems, high and low level alarms, and overspill protection. The present situation is much more environmentally friendly. The potential for a spill is less today than ever before. HOWEVER, according to the proposed rule, the U. S. Army will now be required to have a "PE certified" spill plan on hand." (L3) Impermeability. "EPA should confirm that the term "impervious" to oil for 72 hours means that the containment system ensures that oil is not discharged to navigable waters within 72 hours, a determination to be based on good engineering practice." (70) Impracticability. "The EPA should modify the proposal to eliminate elements that are impracticable (i. e., secondary containment for electrical equipment) or that impose undue costs compared with the avoided risk (i. e., certification by an independent, rather than in­ house engineer; preparation of an OPA response plan where secondary containment is impractical)." (70) Manmade structures. "The EPA should modify the risk criteria to ensure that only facilities that pose a real risk of harm to navigable waters are covered by the program (i. e., the fact that oil may create a sheen on the water is not the type of "harm" envisioned by the statute and regulatory costs should not be imposed to avoid minimal or theoretical risks; manmade structures that serve operational purposes should be considered in evaluating the risk posed by a facility)." (70) Secondary containment, changes in. "Require that the plant operator sign­ off on a memo to the file whenever the capacity of the secondary containment system is decreased either temporarily or permanently. The memo should list contingency plans, temporary containment measures or mitigating measures (e. g., reduce tank volumes). This happens quite often when some construction is going on inside the 70 containment ­ sometimes even to the point that no significant secondary containment capacity remains in place." (40) Sufficient freeboard. "Specify a required freeboard. Many people check the capacity but fail to recognize that if the final freeboard is only 1 or 2 inches then oil may be released." (40) "Should to Shall to Must "Clarification. "Ford believes that absent `shall', all `should' language represents agency preference and possibly, good practice. There may be other ways to accomplish the same thing. Thus, only `shalls' indicate regulatory requirements and inflexibility." (44) "Although there is some merit to the agency's legal interpretation of this matter (in interpreting should to mean shall because of the mandatory language of 112.3) we believe that changing this language to reflect all shalls throughout the rule is unnecessary. PNM believes that such a change would eliminate the needed flexibility that implementation of this rule demands due to the differences in facility age and design." (79) Tank manufacturer liability. "... (T) he tank manufacturer remains the most knowledgeable entity in how his/ her tank design complies with all pertinent UST or AST requirements. Therefore, failure to inform a prospective client could naturally result in a subrogated liability against the tank manufacturer. Such a movement is already taking place as demonstrated in the December 7­ 11, 1997 Uniform Fire Code Hearings in Tucson, Arizona." (73) Warning lights, etc. We should reconsider 40 CFR 112.7( h)( 2). (7) Response: Applicability. The issue of whether a facility can due to its location reasonably be expected to discharge oil in harmful quantities into navigable waters or adjoining shore lines is in the first instance a judgment requiring application of good engineering practice. See §112.1( b). If the RA disagrees with the facility's determination, he may require the preparation of either a total or partial plan. See §112.1( f). Applicable items. For a discussion on applicable items in an SPCC Plan, see §112.7( a)( 2) in the preamble to today's final rule and the 1991 Comment Response Document. See also the discussion on good engineering practice under §112.3( d). Burden reduction. We disagree that the rule does not do anything to reduce the record keeping or the information collection burden. Burden is reduced by approximately 40% over the current rule. We believe that performance standards, rather than design standards, are preferable, because they give a facility flexibility to accomplish prevention requirements in the most efficient way. 71 Certification by other environmental professionals. See the discussion under §112.3( d) in the preamble to today's final rule and the 1991 Comment Response Document. Completely buried tanks. For a discussion on the applicability of the SPCC rule to completely buried tanks, see the discussion under §112.1( d)( 2)( i) in today's final rule and the 1991 Comment Response Document. "Delegated" States. We note that we do not delegate our authority under the SPCC program to States. For a discussion of State prevention rules, see §112.7( j) of today's final rule and the 1991 Comment Response Document. FRP applicability. The issue concerning §112.20( e) is covered in the Comment Response Document for the 1993 final rule. Inspection periods. For a discussion of the merits of prescribed inspection frequencies or the use of industry standards, see section IV. J of the preamble to today's final rule and the 1991 Comment Response Document. Integrity testing. We address integrity testing in the preamble to today's final rule and in the 1991 Comment Response Document. See §§ 112.7( d) and 112.8( c)( 6). Loading areas. For a discussion on loading areas, see §112.7( h) in today's final rule and the 1991 Comment Response Document. See also 40 CFR part 112, Appendix A, section II.( I). More information. We disagree that we should require the owner or operator to submit a letter to the EPA stating that he has an SPCC Plan for each facility over the threshold, and stating who is the certifying engineer. This information may be ascertained by onsite inspection. Oil, definition of. Should you have any question about a specific substance, you should contact the appropriate Regional SPCC program. See also the discussion concerning the definition under §112.2 in the preamble to today's final rule and the 1991 Comment Response Document. PE­ related issues. See the discussion under section IV. D and §112.3( d) of today's preamble and the 1991 Comment Response Document. Mandatory requirements, PEs. We disagree that we are "going in the wrong direction" by clarifying that the rules are mandatory. We note that we are not requiring a third party PE for certification. See the discussion under section IV. D and §112.3( d) of today's preamble and the 1991 Comment Response Document. 72 PE notification. We address PE­ related issues in the preamble to today's final rule under section IV. D and §112.3( d) and in the 1991 Comment Response Document. Secondary containment. We address secondary containment issues in the preamble to today's final rule and in the 1991 Comment Response Document. See §§ 112.7( c), 112.7( h)( 1), 112.8( c)( 2), 112.8( c)( 11), 112.9( c)( 2), and 112.10( c). Accumulation of storm water. Concerning "sufficient freeboard" see the discussion under §112.8( c)( 2) in today's final rule and the 1991 Comment Response Document. Available secondary containment. We address secondary containment issues in the preamble to today's final rule and in the 1991 Comment Response Document. See §§ 112.7( c), 112.7( h)( 1), 112.8( c)( 2), 112.8( c)( 11), 112.9( c)( 2), and 112.10( c). See also the discussion concerning the definition of "storage capacity" at §112.2 in the preamble to today's final rule and the 1991 Comment Response Document. Impermeability. See the discussion under §§ 112.7( c) and 112.8( c)( 2) in the preamble to today's final rule and the 1991 Comment Response Document. Manmade structures. See also the discussion under §112.1( d)( 1)( i) in the preamble to today's final rule and the 1991 Comment Response Document. Sufficient freeboard. Concerning "sufficient freeboard" see the discussion under §112.8( c)( 2) in today's final rule and the 1991 Comment Response Document. "Should to Shall to Must "Clarification. For a discussion of the "should to shall to must" editorial clarification, see section IV. C of the preamble to today's final rule and the 1991 Comment Response Document. Tank manufacturer liability. Tank manufacturer liability is an issue for the courts, not this rulemaking. Warning lights, etc. We address warning lights in the preamble to today's final rule and in the 1991 Comment Response Document. See §112.7( h)( 2).

epa

2024-06-07T20:31:41.182792

regulations

EPA-HQ-OPA-1997-0002-0070

Supporting & Related Material

SPCC­ 7­ 3­ 7 OPA­ 1997­ 0002­ 0070 RESPONSE TO COMMENTS DOCUMENT FOR THE 1991 SPILL PREVENTION, CONTROL, AND COUNTERMEASURE (SPCC) RULEMAKING U. S. Environmental Protection Agency i TABLE OF CONTENTS Response to Comments Document for the 1991 Spill Prevention, Control, and Countermeasure (SPCC) Rulemaking Page Introduction .......................................................... 1 I: Phase Oneandits relationship to Phase Two.......................... 3 A: Coordination with other agencies .............................. 4 B: Worst case scenario ........................................ 4 C: Changing should to shall ..................................... 5 D: Ashland oil spill should not be the basis for changes to the SPCC rule . 7 II: Proposed Notification requirements ­ §112.1( e) ........................ 9 A: General comments ......................................... 9 B: Contentofnotification form.................................. 18 III: Discretionary provisions ......................................... 21 A: Stating the design capabilities of drainage systems .............. 21 B: Different requirements for large and small facilities ............... 22 IV. General applicability and notification ................................ 27 A: Scope of the rule ­ "Harmful quantities" ­ §112.1( a), (b), (c) and (d)( 1) 27 B: Exemption of completely buried containers ­ §112.1( d)( 2)( i) and (d)( 4) 32 C: Exemption of permanently closed containers ­ §112.1( b)( 2) and (d)( 2) 38 D: Exemption of Minerals Management Service (MMS) facilities 112. 1( d)( 3).............................................. 40 E: Regulatory threshold ­ §112.1( d)( 2) .......................... 42 F: WastewaterTreatment­§ 112. 1( d)( 6) .......................... 60 V: Definitions­§ 112. 2 ............................................. 63 VI: Preparingandimplementing Plans ................................. 94 A: Time frames for preparing and implementing Plans­§ 112. 3( a),( b),( c) .................................... 94 B: Good engineering practice ­ §112.3( d) ........................ 100 C: PE certification requirement ­ §112.3( d) ....................... 102 D: Whether the certifying PE may be a facility employee or have any direct financial tie to the facility ­ §112. 3( d) any direct financial tie to the facility ­ §112. 3( d) ................................... 109 E: PEs­ Stateregistration­§ 112. 3( d) ­§ 112. 3( d) ................. 112 F: PEs­ Site visits ­§ 112. 3( d)................................. 113 TABLE OF CONTENTS (continued) Page ii G: PE Plan certification ­ completion of testing procedures ­ §112.3( d) . 117 H: Plan location at the facility ­ §112. 3( e) ........................ 118 I. Extension of time ­§ 112. 3( f) ............................... 120 VII: Amendment to a Plan by the RA .................................. 121 A: Registered agents ­ §112.4( a) and (e) ........................ 121 B: Discharge reports to EPA ­ §112.4( a) ......................... 123 C: General/ other ­ §112.4 .................................... 125 VIII: Amendment to a Plan by the owner or operator ...................... 130 A: Plan amendment by an owner or operator ­ §112.5( a) ............ 130 B: Periodic reviewof plans­§ 112. 5( b) .......................... 137 C: PE certification of technical amendments ­ §112.5( c) ............. 139 IX: Penalties ­ §112.6 ............................................. 142 X: General substantive requirements ­ §112.7 ......................... 143 A: Reorganization of the regulation ­ §112.7( a) and (a)( 1) ........... 143 B: Deviations­§ 112. 7( a)( 2) .................................. 145 C: Planinformation ­§ 112. 7( a) and( b) .......................... 148 D: Secondary containment ­ §112.7( c) ......................... 167 E: Contingency planning ­ §112.7( d) ............................ 176 F: Integrity andleaktesting ­§ 112. 7( d).......................... 186 G: Inspections, tests, andrecords ­§ 112. 7( e)..................... 197 H: Training­§ 112. 7( f) ....................................... 200 I: Security (excluding production facilities) ­ §112. 7( g) ............. 204 J: Facility tank car and tank truck loading/ unloading racks ­ §112.7( h) . 208 K: State rules­§ 112. 7( j) ..................................... 213 XI: Onshore facility Plan requirements (excluding production facilities) ....... 217 A: Facility Drainage ­ §112.8( b) ................................ 217 B: Bulkstoragecontainers ­§ 112. 8( c) .......................... 221 C: Facility transfer operations, pumping, and facility process ­ §112. 8( d) 250 XII: Onshore production facility Plan requirements ....................... 267 A: Production facilities ­ general requirements ­ §112.9( a) ........... 267 B: : Facility drainage ­ §112.9( b) ................................ 268 C: FEMA requirements ­ proposed §112.9( c)( 3) ................... 272 D: Production facilities ­ bulk storage containers ­ §112. 9( c) ........ 272 E: Facility transfer operations ­ §112.9( d) (proposed as §112.9( e)) .... 277 XIII: Requirements for onshore drilling/ workover facilities ­ §112. 10 ............................................. 282 TABLE OF CONTENTS (continued) Page iii XIV: Requirements for offshore oil drilling, production, or workover facilities ­ §112. 11 ............................................. 285 XV: Relationship to otherprograms of therule........................... 290 A: UST­ part112........................................... 290 B: State programs, SARA Title III, wellhead protection, flood­ related requirements, OSHA, and industry standards ­ part 112 ........... 290 XVI: Economic analysis ............................................. 295 A: Estimated universe of regulated facilities ...................... 295 B: Impacts on smallbusinesses ............................... 296 C: Use of incorrectdata...................................... 298 D: Miscalculation of costs .................................... 299 E: Additional costs .......................................... 303 F: Costs to the electric utility industry ........................... 306 G: Miscellaneous cost issues ................................. 308 H: Miscalculation of benefits .................................. 312 XVII: General comments ............................................ 314 1 INTRODUCTION Purpose of this Document The purpose of this document is to respond to comments received on the proposed rule (56 FR 54612, October 22, 1991) to revise the Oil Pollution Prevention regulation (40 CFR part 112), promulgated under the Clean Water Act (CWA). This proposed rule establishes requirements for Spill Prevention, Control, and Countermeasure (SPCC) Plans to prevent spills of oil by non­ transportation­ related onshore and offshore facilities into the navigable waters of the United States, adjoining shorelines, and other areas specified in the CWA. The proposed revisions involve changes in the applicability of the regulation, changes to the required procedures for completing SPCC Plans, and a new facility notification provision. Background of this Rulemaking The Oil Pollution Prevention regulation, or SPCC regulation, was originally promulgated on December 11, 1973 (38 FR 34164), under the authority of section 311( j)( 1)( C) of the CWA. The regulation established spill prevention procedures, methods, and equipment requirements for non­ transportation­ related facilities with aboveground oil storage capacity greater than 1,320 gallons (or greater than 660 gallons aboveground in a single tank); or buried underground oil storage capacity greater than 42,000 gallons. Regulated facilities were those that, because of their location, could reasonably be expected to discharge oil into the navigable waters of the United States or adjoining shorelines. We have amended the SPCC requirements a number of times, and those amendments are described in an October 22, 1991 Federal Register notice. 56 FR 54612. In the October 1991 notice, in addition to the description of past amendments, EPA proposed new revisions that involved changes in the applicability of the regulation and the required procedures for the completion of SPCC Plans, as well as the addition of a facility notification provision. The proposed rule also reflected changes in the jurisdiction of section 311 of the Act made by amendments to the Act in 1977 and 1978. We have finalized some of those proposed revisions, with modifications, in this rule. Organization of the Comment Response Document To develop this document, we first reviewed the letters received in the public docket. We then identified relevant issues raised by the commenters based on the content of the proposed rule. Finally, we developed responses to these summaries, carefully addressing the issues in each issue category. The following pages present the comments and responses. We arranged the document according to the subjects listed in the Table of Contents. We assigned a reference number to each letter we received. We include reference numbers in the summaries to identify the commenters who addressed each issues. For 2 letters that addressed numerous issues, the corresponding letter number will appear multiple times throughout the document. In this comment response document, the "current rule" means part 112 as codified in the most recent edition of the Code of Federal Regulations, as amended by any subsequent part 112 final rule published in the Federal Register since that codification and preceding the publication of this final rule. 3 Category I: Phase One and its relationship to Phase Two Background: In the wake of the 1988 Ashland Oil Spill in Floreffe, Pennsylvania, we formed the Oil Spill Prevention, Control, and Countermeasure (SPCC) Program Task Force (the Task Force) to examine Federal regulations addressing oil spills from aboveground storage tanks (ASTs). This Task Force recommended that we distinguish guidance from required provisions, establish more technical requirements for all facilities subject to the oil spill prevention program, and require facility­ specific oil spill contingency planning. Further, having found that we lacked an adequate inventory of regulated facilities, the Task Force recommended that we collect information on regulated facilities (for example, the number of ASTs at a facility. Finally, the Task Force recommended that we strengthen our facility inspection program better to identify violations and encourage compliance. A subsequent General Accounting Office (GAO) report contained similar recommendations. As we explained in the 1991 Preamble, we decided to address the Task Force and GAO recommendations in two phases. In Phase One, we addressed those oil program provisions we could change without performing substantial, additional data gathering. As an element of Phase One, we proposed to require elementary contingency planning of a kind already in most SPCC Plans. In Phase Two, we implemented new mandates arising under the Oil Pollution Act of 1990 (OPA), including requiring substantial contingency (or response) planning. In 1991, we also requested comments on the relationship between Phase One and Phase Two. We issued the Phase Two or facility response plan (FRP) rules in 1994. 59 FR 34070, July 1, 1994, codified at 40 CFR 112.20 and 112.21. Comments: Timing of Phases. "This second phase should be expedited to provide the increase prevention and containment that will result from improved SPCC plans." (L1) We should avoid timing constraints that would require regulated owners and operators to produce a Phase One plan, a Phase Two plan, and perhaps, a third plan to meet state­ specific requirements. (67, 79, 91, L10) The requirement for contingency plans should be phased in, allowing each facility to delay actual preparation until the next statutorily­ mandated SPCC Certification. (L20) Facility Notification. Premature. Notes that OPA responsibilities have not yet been delegated to EPA. "Until such a delegation is made, the Agency cannot determine what its responsibilities will be. At this time, it is simply unreasonable for the Agency to burden the regulated community with a notification process which is not necessary." (42, 91, 141, 167, 182) "Until EPA has outlined its data needs and how the information will be used under Phase Two, expanding the notification requirements at this time is unwarranted, unjustified and unnecessarily costly." (167) 4 Timely. "Requiring this additional information during Phase I (instead of deferring to Phase II), will enable the Regions to have more time to develop a matrix for determination of facilities posing significant harm/ significant and substantial harm. Of all the information requested on the notification form, the additional information listed above is most likely to be confusing to the regulated community, and hence the Regions should be afforded as much lead time as possible to clarify and troubleshoot the screening data submitted." (168) Public hearings. "In addition, since EPA offers these proposed rules based only on the views of a governmental task force with no representation of the regulated community, and since EPA's rules seek to impose burdens on the regulated community as a class based on one large, unfortunate bulk storage incident, Cyprus respectfully requests that appropriate public hearings be held." (35) Response: Timing of Phases. We appreciate the comment that supported our early efforts to collect information on SPCC­ covered facilities. However, because the OPA­ mandated deadlines made it necessary for us to concentrate our efforts on promulgating the Phase Two rule; we issued a Phase Two proposed rule in 1993 (58 FR 8824, February 17, 1993), and a Phase Two final rule in 1994 (59 FR 34070, July 1, 1994). Facility Notification. We have decided to withdraw the proposed facility notification requirement because we are still considering issues associated with establishing a paper versus electronic notification system, including issues related to providing electronic signatures on the notification. Should the Agency in the future decide to move forward with a facility notification requirement, we will repropose such requirement. Public hearings. Public hearings on the rule were unnecessary due to the extensive written response we received, elucidating all sides of most issues. I­ A Coordination with other agencies Comments: Asks us to coordinate the Phase Two rulemaking with other Federal and State regulatory activities, reasoning that government entities should avoid creating conflicting requirements and duplicating efforts. One State noted that it had received many comments on its requirements. (102, 193, 193, L10). Response: We did coordinate the Phase Two rulemaking with other agencies. See the preambles to the 1993 proposed rule and 1994 final rule, and 1994 Response to Comment document for details. I­ B Worst case scenario Comments: Worst case planning. "ACMS believes that facilities with adequate secondary containment should not be required to install leak detection monitors or 5 prepare and submit a plan for responding to the largest foreseeable discharge." (51) "Our experience in assisting facilities after a spill has shown that many of them anticipated ­ and planned for ­ a spill of far less serious magnitude than the one that actually occurred. Accordingly, 3M believes the SPCC regulation should expressly require the calculation of a worse case scenario as part of each contingency plan." (61) Equipment. "3M believes the SPCC regulation should require each contingency plan to document the availability of enough sorbent material and other equipment to manage a worst­ case spill." (61) Response: Worst case planning. We agree that an SPCC facility should not have to plan for the worst case scenario. Contingency planning following the provisions of part 109 requires planning for "varying degrees of response effort depending on the severity of the oil discharge." 40 CFR 109.5( d)( 4). We require worst case scenario planning for higher risk FRP facilities. We addressed comments and issues concerning a worst case discharge in our FRP rulemaking. Equipment. Part 109 requires provisions that include the "identification and inventory of applicable equipment, materials and supplies which are available locally and regionally," and "an estimate of the equipment, materials and supplies which would be required to remove the maximum oil discharge to be anticipated." 40 CFR 109.5( c)( 1) 2). I­ C: Changing should to shall Issues: In §112.7 of the current rule, we set general guidelines for the preparation and implementation of a Plan. In the 1991 proposal, we substituted the words requirements and shall for the words guidelines and should. Comments: Support for proposal. "All the major federal reports following the Ashland Oil spill recommended that SPCC requirements be more specific so they could be better enforced. Commendably, EPA has in several places in the SPCC proposal put in mandatory language. In several other places, however, EDF urges EPA to use language that would make certain provisions mandatory, rather than retaining flexibility which may result in adverse impacts on the environment." (27, 44, 53, 67, 148, 185, L17) Opposition to proposal. "API also suggests that the proposed new requirements as discussed in this rule remain as recommendations only for such facilities designated as `small' according to this definition and/ or that all the newly proposed `shalls' (as in the current SPCC regulation) for all such `small facilities'." (67) The existing guidelines should be relaxed if we change should to shall. (101) Stresses the need for "practical flexibility." Our original intent was to use should to provide a flexibility that would end with the change to shall. (110, L27, L27) A set of mandated principles is inconsistent with good engineering practice. "( G) ood engineering practice begins with the base requirements and develops the most practicable solution." (45, 170) 6 Guidance documents. "...( D) iscretionary provisions might be better set forth in a separate guidance document, so as not to confuse the regulated community." (27) Substantive change. The change is not merely a clarification in rule language. The proposal is a substantive change for which we failed to give proper notice. The change from should to shall would impose a new regulatory burden on an owner or operator by requiring that he modify an existing SPCC Plan and facility. It would be "inappropriate for the EPA to issue a final rule until fair public notice and opportunity for comment has been given." (32, 35, 63, 127, L27) New costs or burdens. The change would substantially increase costs for production facilities. (28, 101, 110, 125, 146, 189, L27) This increase in costs would be enough to shut down some facilities. (28, 110) We have no substantive basis to justify making the current provisions mandatory. (101, 125, 189) It is more cost effective for the facility owner or operator to retain discretion in selecting the exact requirements necessary for the specific facility location. (125, 173) We have underestimated the costs of the changes. (125, L27) Small facilities. Recommends that shall remain should for small facilities. (91, 116, 133, 173, 182) New requirements "should not apply to production facilities with tanks of 1,000 barrels (42,000 gallons) or less." (91) We should allow the owner or operator of a small or medium size facility more discretion than owners or operators of "large bulk oil storage facilities with over 42, 000 gallons of capacity." (116) We should limit analysis requirements to "tanks larger than 660 gallons and electrical equipment larger than 10,000 gallons because it is impractical and unnecessary to do such analyses for all smaller units." (125) "The `should's' to `shalls' change should not apply to small production facilities... with less than 3, 000 barrels of oil storage capacity." (133) We should exempt facilities with less than 1, 000 barrels of oil storage capacity. (173) Response: Support for proposal. We appreciate commenter support of the change from should to shall. We believe that we must retain flexibility for a deviation when an owner or operator faces unique circumstances. No single design or operational standard can be prescribed for all non­ transportation­ related facilities. Substantive change. We disagree that the change is either substantive or contrary to legislative intent. Section 311( j)( 1)( C) of the Act authorizes the President and, through delegation, EPA, to establish "procedures, methods, and equipment and other requirements for equipment to prevent discharges of oil and hazardous substances from vessels and from onshore facilities and offshore facilities, and to contain such discharges." That authority is ample to provide the basis for a mandatory SPCC rule, that is, a rule that establishes "requirements ... to prevent discharges." We also disagree that the proposed rule failed to provide proper notice and comment. The preamble to the 1991 proposed rule fully explained the rationale for the proposed change (56 FR 54620, October 22, 1991), and numerous commenters responded. Furthermore, we have always interpreted and enforced our rules as mandatory requirements. 7 EPA recognizes, however, that this clarification may result in certain owners or operators of regulated facilities recognizing for the first time that they have been and are subject to various provisions of part 112. Such owners and operators should, of course, take all necessary steps to come into compliance with this part as soon as possible. If an owner or operator reports to EPA that he is out of compliance with part 112, he may qualify for a significantly lesser penalty under EPA's policy entitled "Incentives for Self­ Policing: Discovery, Disclosure, Correction and Prevention of Violations" that was published at 60 FR 66706, on December 22, 1995. Furthermore, in exercising its prosecutorial discretion, the Agency always takes into account the good faith and efforts to comply of an owner or operator who has been in noncompliance with applicable laws and regulations. Good engineering practice. We disagree that mandatory requirements are inconsistent with good engineering practice. We continue to allow deviations from most substantive rule requirements, based on good engineering practice (§ 112.7( a)( 2)) or impracticability (§ 112. 7( d)). New costs or burdens. We disagree that this editorial change imposes any new regulatory burdens or costs because it imposes no new requirements. Nor will the clarifying change add to the information collection burden – it remains the same. Small facilities. We disagree that the should to must change will impose new requirements or costs for small facilities. We have modified the applicability thresholds in the rule so that many small facilities are no longer covered. In addition, we have included general deviation provisions in §112.7( a)( 2) and (d). I­ D Ashland oil spill should not be the basis for changes to the SPCC rule Comments: Ashland spill. "The thickness of the Ashland lower chime was more than 1 inch. On the other hand, oil and gas field tanks, are fabricated from 10 gauge steel (0.10 inches thick). Steel of this thinness is not impact or thermal stress sensitive because of ease of rolling thin steel plates. Accordingly, an Ashland type spill is extremely likely to occur in oil and gas operations. Additionally, EPA, in the preamble, cites does not data demonstrating such spills or releases are liable to occur in E& P operations." (31, 34, 110, 114). Actual risk, major spills. In proposing changes to part 112, we should assess actual situations that threaten public health and the environment. (52, 139) We should have different SPCC Plan requirements for facilities based on different risks to human health and the environment. (86) We should make part 112 address the prevention of potential major oil spills only, adding that significant changes in the SPCC rule would not "improve containment facilities insofar as Appalachian Producers are concerned." (101) Supports clarification that "SPCC plans are required (not voluntary) of facilities which pose a certain potential harm to navigable waters if oil is released from storage tanks." (164) 8 Small facilities, exploration and production facilities. Regulations promulgated as a result of the Ashland oil spill should not apply to small aboveground tanks. (28, 69, 79, 101, 110) The proposed regulation unduly burdens small facilities, borderline sized facilities, facilities distant from waterways, or facilities in rural areas with construction and equipment standards that apply to Ashland­ type facilities. (32, 72) We developed the proposed changes to prevent large Ashland­ type spills. The proposed changes are not applicable to oil and gas operations which have small volumes of stored oil (110), or exploration and production (E& P) facilities which are generally not situated near major waterways (110, 114). Response: Ashland spill. As noted in the preamble to the 1991 proposed rule, we reevaluated part 112 as a consequence of findings and recommendations by the SPCC Task Force formed in the aftermath of the Ashland spill, and of similar findings in a GAO report. Although the Task Force report focused on preventing large, catastrophic spills; the report addressed many aspects of the Federal oil spill prevention, control, and countermeasure program. The Task Force report was one impetus for the 1991 proposed rule, however the proposed rules in issue were meant to address broader issues than the Ashland spill and similar spills. See 56 FR 54612­ 3, October 22, 1991, for a detailed discussion of the reasons supporting the 1991 proposal. Actual risk, major spills. The changes to the rule do address actual situations that threaten public health and the environment. A facility may have different SPCC Plan requirements based on different risks to human health and the environment. We disagree that the rule should address the prevention of potential major oil spills only. Small discharges of oil may be harmful to the environment. Small facilities, exploration and production facilities. We disagree that small facilities or oil and gas E& P facilities should fall outside of the SPCC program structure. Such facilities store or use oil and may be the source of a discharge as described in §112.1( b). Therefore, they must be subject to part 112. Potential harm. A facility posing a reasonable possibility of a discharge as described in §112. 1( b), and meeting other applicability criteria, is subject to the rule. 9 Category II: Proposed Notification requirements ­ §112.1( e) II ­ A: General comments Background: In 1991, EPA proposed to require that any facility subject to its jurisdiction under the Clean Water Act which also meets the regulatory storage capacity threshold notify the Agency on a one­ time basis of its existence. This type of notice is separate from the notice required at 40 CFR 110.3 of a discharge which may be harmful to the public health or welfare or the environment. We did not propose any change to §110.3. We proposed that facility notification include, among other items, information concerning the number, size, storage capacity, and locations of ASTs. The proposal would have exempted from the notification requirement information regarding the number and size of completely buried tanks, as defined in §112.2. The rationale for notification was that submission of this information would be needed to help us identify our universe of facilities and to help us administer the Oil Pollution Prevention Program by creating a data base of facility­ specific information. We also asked for comments regarding the form on which notification would be submitted, and on various possible items of information that could be included besides the ones proposed. Lastly, we asked for comments on alternate forms of facility notification. 56 FR 54614­ 15. Comments: Support for proposal. There is generally no current procedure whereby we could identify the universe of sites subject to the SPCC rule, and an inventory of these facilities is necessary. (27, 44, 51, 53, 62, 91, 107, 121, 135, 154, 164, 168, 181, 182, L5, L10, L11) Additional information. Age of containers. "The age of tanks may not correspond to its potential to spill. Depending on the product stored, thickness of plate, type of construction, and any repairs or reconditioning done, a tank's age is not a good indication of soundness." (51) Adverse weather. "The question of adverse weather is subjective. What may be one facilities [sic] adverse weather may be another's normal weather. The potential should be identified by the local emergency planning committee or the US geological service [sic]." (51) Cost of additional information. Asking for more information would increase the reporting burden and raise compliance costs to the tens of millions. (125) Environmentally sensitive areas. "These locations may be unknown to the facilities and should be identified by the local emergency planning committee." (51) We proposed to require the owner or operator to provide additional information (i. e., location of environmentally sensitive areas, potential for 10 adverse weather) which is "completely beyond reason." These requirements would be costly and time consuming. (31, 34) Opposes following items on the notification form: spill histories, age of tanks, location of environmentally sensitive areas, and potential for adverse weather. (75) A general request for information on environmentally sensitive areas and the potential for adverse weather would not help the development of Area Plans, because any response was likely to be speculative. (103) LEPCs, other emergency responders. We should require an owner or operator to submit the SPCC Plan to the appropriate Local Emergency Planning Committee (LEPC). (43) On­ scene Coordinators (OSCs) should inform LEPCs of SPCC rule violations. ( L1) We should encourage facilities and LEPCs to conduct exercises together, in conjunction with OSCs and local fire departments. (L1, L11) SERCs, OSROs. We should require owners or operators to submit the proposed notification information to State Emergency Response Commissions (SERCs) (27, L11), oil spill response agencies (27), and States (154). This information will help States identify regulated facilities. (L11) Other owners. Notification should include names of the "owner of the facility, owner of the improvements at the facility, and the owner of the land at the facility. ... Perhaps one of the most significant landowners in the country who is prejudiced by the absence of a requirement for landowner involvement in the preparation of an SPCC Plan is the United States Government. " (43) PEs. We should require an engineer employed by the owner or operator to prepare and sign the notification. (75) Placards. We should require an owner or operator to display a placard that includes ownership information and a unique facility identification number. (154) Product stored. We should require information on the product stored in each tank and how it is delivered to the facility. We should collect tank data similar to the data we collect for underground storage tanks. (111) SPCC compliance. The notification form should include: "an affidavit signed by a member of management within the owner or operator's management certifying that the facility's SPCC Plan has been prepared in accordance with all relevant provisions of 40 CFR part 112 and has been placed in effect...." (43) Address. Suggests use of longitude or latitude, or Universal Transverse Mercator system, or a mailing address for a facility without a street address. (78, 101, 116, 121, L11) 11 Alternatives On­ site surveys. We should obtain additional information through statisticallyrepresentative sampling using on­ site surveys. (L12) Other Federal, State, and local sources. "If the Agency needs additional information for its database, such as MSDS, it can certainly obtain this from the myriad of other federal, state, and local databases for which we are required to submit information." (161) NRC records. "For example, records available at the National Response Center and other published sources may be used to identify areas of the country and/ or locations where there significant use and releases of oil exist." (155) SARA duplication. SARA duplicative. "I have never received one request for explanation of any SARA submitted information from LEPCs or fire departments." (11) Further that this type of information is readily available without the SARA Title III reporting requirements (e. g., through exploration or production facilities). "Similar information required by the proposed notification is already reported under other programs, such as SARA." (27) "Notification requirements have essentially been fulfilled by the SARA Title III regulations." (28) The proposed rule is duplicative of SARA Title III regulations. (101) We should exempt owners or operators reporting through SARA Title III from any part 112 notification requirements. (113) Asks us to consider modifying the SARA Title III reporting requirements to satisfy our need for additional notification information. (118) Recommends that we permit using the Tier II form or proposed Appendix B to meet the proposed SPCC one­ time notification requirement. (145) Opposes the notification requirement because we already have the requested information in the forms of SARA 311 and 312 reports. (187) SPCC­ covered facilities pose a hazard equivalent to the hazard at a facility with a threshold amount of an extremely hazardous substance (EHS). (L1) SARA not duplicative. States presently are preparing and maintaining data bases that the public does not use or want. With the exception of Local Emergency Planning Committees (LEPC) in large cities, no one uses the SARA Title III data. (110) SARA section 311/ 312 submissions were intended for the public and not to notify the Federal government of environmental threats posed by oil storage facilities. (168) SARA and 313. Recommends that if we decided against accepting the SARA Title III form in lieu of the proposed notification form, we should let 12 owners or operators submit the SPCC and section 313 reports at the same ti me. (71) State regulatory agencies or industry trade association surveys. (31, 42, L17) Threshold for notification. 42,000 gallons. We are creating an unnecessary burden for ourselves and industry by requiring notification from all SPCC facilities. We should require notice only for facilities with more than 42, 000 gallons of bulk storage capacity. We should require notice for small and medium size facilities only if there has been an oil spill from the facility within the preceding three years. (114, 116) 100,000 gallons. (136) Applicability. Discharge history. We failed to explain in the notification form that part 112 does not cover a facility unless it is reasonably likely to discharge oil into U. S. navigable waters (and meets the other SPCC program criteria). We should address the connection between part 112 applicability and the likelihood that a facility may discharge oil into navigable waters. (48) The notification provisions apply to facilities that "may" discharge harmful quantities into navigable waters. In the rule, we should clarify how we intend to determine which facilities "may" discharge harmful quantities and who will make this determination. (111) We should regulate facilities that have had spills, rather than those that have not had spills. (132) SPCC facilities. We should require notice for any facility for which an SPCC Plan is required. (43) We should require the notification form only for a part 112 facility. (149) "Unacceptable risk." Asks us to decide what constitutes "unacceptable risk," rather than requiring an owner or operator to register all aboveground tanks. We should use a given facility's reported spill history as a prioricriterion for determining which tanks the owner or operator must register. (132) Dun & Bradstreet numbers. Exploration and production facilities rarely have Dun & Bradstreet numbers. (42, 58, L12) Enforcement. To ensure notification, many States penalize those who deliver regulated substances to non­ compliant UST facilities. (76) We should consider focusing upon non­ reporting owners or operators rather than imposing an additional burden on industries already heavily­ regulated. (162) 13 Facility diagrams. Section 112.1( d) should be rewritten because it seems to require otherwise exempt facilities to comply with facility notification requirements, such as providing facility diagrams. (133) Format. Owners or operators will copy the notification form from the Federal Register, and will not submit it as a one­ page, double­ sided form. (27) Suggests the following: "( P) lease return the notification form to EPA unfolded in a 9­ inch by 12­ inch envelope." (48) We should permit submitting a computer­ generated copy of any final notification form and provide for electronic data submission. (101) EPA and USCG should use the same form. (171) Hazardous chemicals. We should revise our discussion of petroleum products in the Preamble, because crude oil is not a "hazardous chemical," nor is it subject to SARA Title III reporting requirements. (34) Information collection burden. We underestimated the burden of completing and submitting the notification form. (31, 34, 35, 48, 86, 187, 192) If we require more information, we would increase the reporting and record keeping burden on industry. (79, 125, 164) Compiling more information, in turn, would mean increasing the time for submitting the notification form. (34, 95, 102, 168, 191, L7) Navigable waters. There is no definition of navigable waters on the form, making it difficult to answer questions concerning them. (31, 41 48, 58, 62, 67, 79, 85, 86, 107, 146, 160, L17) Unreasonable distance. "The categories for reporting distance to navigable waters exceed reasonable distances. Facilities `more than 10 miles' from navigable waters will rarely, if ever, reasonably be expected to discharge oil in quantities that may be harmful, into or upon the navigable waters of the United States. This is also probably true beginning at category 4–`½ miles'." (42) We should specify a minimum distance to navigable waters, on the theory that only facilities within a certain distance would have a reasonable possibility of discharge to such waters. (42, 125) Opposition to proposal. Differing facilities. We should issue another proposal with different requirements for different kinds of facilities. (31, 86) Exploration and production facilities. Drilling rigs move from location to location as often as every few months. (67, 85, 91) Duplicative requirement. It is unnecessary, because the information sought might be better obtained from other sources, e. g.: State sources (101, 111, 113, 165, 166, 188, L15); SARA Title III reports ( 58, 70, 71, 89, 101, 113, 114, 145, 162, 165, 169, 187, 188, 192, L12, L15); NPDES permits (56, 145); underground 14 storage tank regulations (149); emission inventory programs (25); industry trade association surveys (31, 160, and 161); fire regulatory authorities (65); DOT's maps and records rulemaking (L30); and the Minerals Management Service (133). Proposal includes duplicative reporting requirements. (131) Electric utilities. Because hundreds of thousands of utility facilities will be required to submit notification forms, our proposal would impose a substantial burden on electric utilities. Our proposed reporting requirement would cost the utility industry several million dollars. (125) Format. The notification form does not provide the information that the EPA Task Force report recommends we collect, nor is its collection of AST information as comprehensive as the form used for underground storage tank (UST) notification under Appendix I of 40 CFR part 280. (44) Section 112.1( e)( 2) should read: "The written notice shall be provided either by submitting a copy of the facility's 312 report or by using the EPA form." (71) Inventory, not capacity. Opposes using the information obtained through the SARA Title III notification requirement as a substitute for the SPCC one­ time notification requirement because the SARA Title III program measures inventory, not capacity. Some tanks may not be in use, may not be filled to capacity, or may store a non­ oil product. Therefore, we would not receive a correct estimate of potential discharge from SARA Title III submissions. To reduce the paperwork burden, we should explore alternative filing methods, including accepting the SARA Title III form instead of the proposed Appendix B notification form. (51) Jurisdictional objections. Opposes the notification requirement, and asserted that the proposal would apply to facilities not subject to the SPCC rule. (L12) Minimum necessary. The initial notification requirements should be minimal and limited to the information in Sections I, II, and III of Form B. (136) Obsolescence. The information collected through the notification form would quickly become obsolete, but requiring updated facility notification forms when changes occur would be too burdensome. (187, 191, 192) Small facilities. The benefit of having this information for small facilities is not great enough to justify requiring these facilities to expend the resources to prepare this information. Recommends that we initially require that a facility exceeding a given storage capacity (e. g., 42,000 gallons) submit this information. We could use this initial information to evaluate the usefulness of the information for all facilities. (58, 67, 78, 85, 91, 105, 109, 114,115, 136, 182) Small facilities may not be able to employ sufficient staff to notify us automatically before facility operations begin. (101, 165, L15) 15 Terrorists. Putting the number and location of oil storage tanks in an easily accessible database could provide an "intelligence windfall" to terrorists and other enemies of the U. S. (132) Wasteful. The proposed notification requirements in §112.1( e) are wasteful, burdensome, and serve no oil pollution prevention purpose. (31) Outreach. We should conduct outreach, patterned after the UST program, to ensure that owners or operators are aware of the proposed requirement. (L6) We should establish an information hotline for the regulated community, in case individuals have questions on how to complete the notification form. (168) We should also request information on oil spills. Linking facility characteristics to spill events would help us develop regulations and define the universe of facilities most in need of oversight. (175) Owner or operator. Requests clarification on who must provide notice when the owner or operator of the facility are not the same. (33, 48, 115, 116) Permanently closed tanks. "Does the Agency intend that information on permanently closed tanks be included in this notification? " (84) Program administration. We "found in review( ing)... the SPCC program that... numbers, storage capacities, and locations of aboveground oil storage facilities are needed to effectively administer the program" (56 FR 54614, Column 3). Asks what we meant by "effectively administer( ing) the program." (110) SIC codes. We should omit the three "extra" SIC code boxes from the notification form, to avoid confusion (33, 87); there were no codes listed for edible oil facilities (137); and the codes listed were misleading in that they did not cover all possible industries regulated (155). Accuracy. EPA used inaccurate SIC codes. (67, 85, 102) Small containers. There is no space on the form for containers less than 250 gallons. Asks whether we intend to exclude containers under 250 gallons from the rule. (76) We should establish a de minimis capacity for new facilities subject to this regulation, which would require giving notification within six months of beginning operations. (L7) States, notice to. We should require that a copy of the notification form be sent to the State Emergency Response Commission (SERC) and Oil Spill Response Agency. Sharing notification information with SERCs would benefit EPA and the States. (27) We should require an owner or operator to inform the State when he sends EPA a notification form. Alternatively, we should compile notices we receive and provide that information to the State. (52) 16 Storage capacity. Requests clarification on whether only aboveground tanks had to be included in the facility description. (13) Asks us to clarify whether total aboveground storage capacity includes those tanks that currently store or will store oil, or tanks capable of holding any substance. (33, 115, 143) Recommends modifying the wording to read "tanks that store oil." (33) We should require that an owner or operator state in the Plan, "the total aboveground storage capacity of the terminal, the total of such capacity that could be used for oil, and the total of such capacity at the time of reporting that is actually in oil storage." (143) Tank size ranges are not divided according to the sizes necessary to determine if a facility is required to prepare a facility­ specific plan as outlined in §112. 1, that is, 1, 320 total gallons or 660 gallons for a single tank. (154) Asks if additional storage capacity would trigger a new notification. (134, 165, 167) Temporary or partial storage. EPA should provide direction regarding partially­ filled tanks or seasonally inactive tanks in Parts II and III of the form. (33) To require an owner or operator to comply with the proposed notification requirements for temporary storage created during an emergency oil spill response, would be impractical and slow down the response effort. (60) Timetables. Before operations begin. Small operators may not be able to employ sufficient staff to notify us automatically before facility operations begin. (101, 165, L15) We should set a notification schedule for such facilities based on the new volume of oil or oil product storage. If the upgraded onsite storage capacity exceeds 10,000 gallons, the notification deadline should be prior to installation, but adds capacity that trips the part 112 threshold. If the upgrade onsite storage exceeds 1,320 gallons, the notification deadline should be within 30 days of installation. (23) Requiring notification before operations begin at a location would result in generating useless, duplicative, and contradictory information. (31) Eighteen months. (86) Electrical equipment. Asks whether we would classify oil­ filled equipment like transformers and oil circuit breakers as oil storage tanks. If they are, completing the notification form for each facility with oil­ filled equipment (substations) would take substantially longer than two months and asked for more time to complete the form. (66) If we regulate facilities with electrical equipment under part 112, it would take six months to a year for those facility owners or operators to gather the information required for the notification form. (125) Electronic format. We should give more time to submit the notification form and should develop an electronic form for owners or operators to scan. (L11) 17 Environmentally sensitive areas. Facility owners or operators needed more than 12 months from the rule's effective date to provide information on environmentally sensitive areas and adverse weather. (34) If we require submission of information on environmentally sensitive areas and adverse weather on Form B, we should extend the time to comply commensurate with the amount of additional information required. (95, 102) If we require submission of information on environmentally sensitive areas and the potential for adverse weather, we should give owners or operators six more months to collect the information so that data are accurate. (L7) Multiple facilities. "For many owners of multiple oil production facilities, it will be impossible to complete the notification process within the two­ month time frame proposed. An extension of the deadline for filing notifications should be considered if an owner operator is filing more than 500 individual facility notifications. ... We propose a six month deadline." (27) Disagrees with the need for a separate notification form for each facility. (58, 71, 78, 101, 145, 165, 188, L12, L15) Nine months. Suggests a nine­ month lead time for submitting the form, starting from the effective date of the final regulation. (L12) Phase­ in. The two­ month submission period was unrealistic. We should have phased reporting, because we would be unable to process the many thousands of notifications we would receive within two­ months. (58) Although it is logical to expect the owner or operator of a new refinery to notify us before beginning operations, it is unreasonable to expect such a notice for a facility that is operating already. (23, 28, 101, 167, L15) Risk. We should establish reporting times based upon risk thresholds, rather than subject both large and small quantity storage facilities to the same twomonth deadline. (23) Six months. Notification within a six­ month period after beginning operations would be more reasonable, if, in fact, any notification is necessary. (101) Six months to a year. With the existing storage capacity threshold for aboveground storage so low, many facility owners or operators subject to the rule may not be aware of it. We should consider adopting new notification thresholds or a reporting deadline based on storage capacity at a facility. Notification deadlines for facilities with more than 100,000 gallons of capacity could be due six months to one year earlier than for facilities with storage capacity less than 100,000 gallons. Many smaller storage facility owners or operators lack the resources to address this regulation. (57, 67, 75, 91, 190, 181) 18 Six months. (48, 52, 71, 75, 77, 92, 105, 107, 116, 128, 133, 135, 145, 150, 155, 167, 182) Three or four months. (87, 90, 93, 143) Twelve months. (31, 34, 189, L2, L30) Two months. Suggests changing the final sentence of the subsection to the following: "With respect to any facility subject to this part which commences operations after [insert date 60 days after date of publication of final rule] or becomes subject to this part after [insert date 60 days after date of publication of the final rule] as a result of increased storage capacity, the operator must provide notification to the Regional Administrator before beginning facility operations." (42) Favor the notification requirement and argue that the proposed notification form and corresponding two­ month response time are appropriate. (54, L7) We should revise the date of notification for new facilities to within 60 days of the date when a covered tank is placed into operation. (145) Two months would be insufficient to collect and submit such information. (191) Questions the proposed two­ month time frame. (41, 48, 54, 58, 71, 89, 103, 175, 181, 187) Updates to notification. Facility notification should be current, and an owner or operator should let us know about any change in storage capacity, operation, or ownership within 30 days. These commenters recommended making a full notification once, and amendments as necessary. (27, 33, 89, 159, 185, L11) Copies requested. Several States requested copies of the notifications EPA would receive (52, 185, L10) Vegetable oil and animal fat facilities. Including vegetable and animal oils in the definition of oil was unreasonable. The CWA's context shows that Congress did not intend to address vegetable and animal oils under the SPCC program. (42) We should ask for less information from vegetable oil facilities (i. e., name, address, number of tanks, and total capacity of tanks). (56) Response: Withdrawal of proposal. We have decided to withdraw the proposed facility notification requirement because we are still considering issues associated with establishing a paper versus electronic notification system, including issues related to providing electronic signatures on the notification. Should the Agency in the future decide to move forward with a facility notification requirement, we will repropose such requirement. II ­ B: Content of notification form Comments: Addresses and zip code. "It won't be possible to give an address and zip code of the facility [sic] due to their rural location." (28, 42, 101) A single regional 19 production office can monitor or operate many different production facilities. We should clarify whether the Agency wants the address of the production office or the legal description of where the facility is located. (42) Crude oil production storage facilities do not have a name, address, and zip code. (58, 187) We should ask for separate facility location and facility mailing addresses so we could later avoid mailing information to an unattended facility. (101) We should allow either the facility address or location to suffice for notification purposes. (133) Authority. Some of the information we proposed requesting is beyond our authority to collect (e. g., facility latitude and longitude, location of environmentally sensitive areas, and potential for adverse weather). (L30) Private wells. If we adopt the notification requirement, we should not include private water wells in the list of water suppliers that the owner or operator must notify. It would be highly impractical and prohibitively expensive for the owner or operator to attempt to locate every downstream private water well. (28, 101) Dun & Bradstreet. Dun & Bradstreet numbers are not available for crude oil production storage facilities. (58) Obtaining Dun & Bradstreet numbers can be very labor intensive or impossible. (42, L12) We should make identification of Dun & Bradstreet numbers optional and not punish facility owners or operators if they do not provide Dun & Bradstreet numbers or if they provide inaccurate ones. (L12) Longitude and latitude. The facility's latitude and longitude should be included on the notification form. (27, 62, 121, 135, 154, 168, L11) Miscellaneous items. We should collect aboveground storage tank information, such as tank status (e. g., currently in use), capacity, age, material of construction, method of construction (e. g., field erected), and substance stored. (44) Supports a requirement that the owner or operator submit additional information on the notification form, including facility latitude and longitude, location of environmentally sensitive areas, potable water supplies, presence of secondary containment, spill history, leak detection equipment and alarms, age of tanks, and potential for adverse weather. (168) Opposes a requirement that the owner or operator provide additional information, such as the latitude and longitude of the facility, location of environmentally sensitive areas and potable water supplies, presence of secondary containment, spill history, leak detection equipment and alarms, age of tanks, potential for adverse weather, and any other additional information. (31, 33, 34, 35, 41, 42, 48, 51, 53, 54, 57, 58, 62, 66, 67, 75, 79, 82, 83, 86, 87, 89, 91, 95, 101, 102, 103, 110, 115, 118, 121, 133, 136, 137, 155, 164, 167, 181, 182, 183, 191, L12, L30). Navigable waters. Asks us to clarify what we meant in the proposed rule when we stated that an owner or operator should provide the "distance to nearest navigable waters" in proposed §112.1( e)( 2)( iii). Asks whether we meant the owner or operator should consider tributaries, wetlands, and sloughs when determining the distance to nearest navigable waters. (62) We should define navigable waters on the form. (76) 20 A facility's distance from "navigable waters" may be meaningless when storm drains are located next to the facility because spilled oil can travel directly through a storm drain to navigable waters. (79) Information on distance to navigable waters is limited and open to various interpretations. (39, 48, 79) An owner or operator may be incapable of identifying the nearest navigable water. (42, 58) Notification should "not include the distance of the facility to the nearest navigable waters, but the distance of each tank from the nearest navigable waters." (L2) Requesting the distance to navigable waters for the nearest tank would unduly skew the database for certain industries. It would be better to obtain information on estimated average distances for each category in Section II of the notification form. (L12) "Site information." We should make some "technical corrections" to improve the notification form, but gave no specifics. (48) We should ask only for site information and should include "a question regarding the need to implement a facility SPCC Plan." (89) Response: See the response to II­ A, above. 21 Category III: Discretionary provisions III ­ A: Stating the design capabilities of drainage systems Background: In 1991, we requested comments on a recommendation that we did not include in rule text that an owner or operator of an onshore facility (other than a production facility) describe the design capability of a facility drainage system in the SPCC Plan if the system is relied upon to control spills or leaks. Comments: Support for description. We should require that owners or operators describe the design capabilities of facility drainage systems in the SPCC Plan. Such a description would help identify all paths of escape for discharges at a facility, assess the spill retention capacity of the facility's containment system, and identify the risks to the public of a discharge. (47, 51, 76, 80, 95, 135, 168, L17) Large or small facilities. EPA should require more detailed drainage information for large facilities with storage capacity exceeding 1,000,000 gallons. At these facilities, a Professional Engineer (PE) should identify all paths of escape for oil discharges, assess the spill detention capacity of the facility, identify the risks of a release to the public, and develop topographic surveys of each facility and the area immediately surrounding the facility. (47) Requirement or recommendation. We should recommend – rather than require – an owner or operator to describe facility drainage system design capabilities in the SPCC Plan. The provision is redundant since other SPCC rule provisions already address this issue. (95, 175) Describing the facility drainage system design capabilities would create unnecessary paperwork and complicate the Plan. (25, 34, 74, 155) Storm event. SPCC Plans should describe the maximum storm event the drainage system can handle. It would be essential to know if the capabilities of the existing system were adequate to handle storm, spill, or leak flows. (80) Response: The question of description of the design capabilities of drainage systems for onshore facilities other than production facilities is adequately covered by rules pertaining to drainage. See, for example, §§ 112.7( a)( 3) and (4), 112.7( b), 112.8( b), and 112.10( c). Therefore, we will not promulgate any additional requirements on this subject. These provisions generally require that a facility owner or operator design the facility drainage system to prevent discharges, or if prevention fails, to contain the discharge within the facility. We note that for facilities with a storage capacity exceeding 1,000,000 gallons, we do, in some cases, require more detailed drainage information (in the facility response plan). 22 III ­ B: Different requirements for large and small facilities Background: In 1991, we requested comments on whether to create a category for large facilities and to require more stringent provisions for such facilities. We also requested comments on whether such provisions should be discretionary for smaller facilities. Comments: Authority. Neither the language nor the legislative history of the CWA compels us to regulate all facilities at which oil is present. (65, 125) The statute confers substantial discretion on us to determine the types of facilities that pose sufficient risk to surface waters to warrant the SPCC regulatory controls. (125) Opposition to proposal. All facilities can pose major impacts to human health and to the environment, regardless of storage capacity. (168) Unnecessary. Such provisions are unnecessary because no risks exist for which the discretionary provisions were proposed. (35, 82) Support for proposal. "Contrary to EPA's concern, §311( j)( 1)( C) of the Clean Water Act does not prohibit different requirements based on facility size." (65) We should regulate facilities based on storage capacity differences. We should distinguish between small and large facilities. Even small cost increases can have a detrimental economic effect on small facilities. (62, 65, 82, 115, 145, 164, 173, 175, L6) EPA's departure from the Task Force's recommendations to regulate facilities based on size "undermines EPA's assertion that the proposed regulations are justified by the Task Force Report." (32) Supports regulation of facilities that could reasonably be expected to discharge oil in harmful quantities. (75) We should have separate requirements for small and large facilities. "Aboveground tanks used by production wells are considerably smaller than those used in the refining and marketing sectors. Further, these wells typically are remote from both major surface waters and population centers, thus posing significantly less risk to the environment than larger facilities." (125) Cites EPA's finding in the 1988 Underground Storage Tank (UST) final rule that "tanks that hold large amounts of regulated substances do pose a relatively larger potential danger to human health and the environment than other, small tanks." (See 53 FR 37111.) We should use the UST finding in the SPCC rule. (125, 170) Risk. We should focus on facilities that pose the greatest risk to navigable waters, rather than focus on facilities of a particular size. (35, 50, 62, 79, 82, 114, 125, 130, 164, 167, L17) We should focus on the engineering and design of the storage and containment plan. (35) We should limit the requirements to high­ risk facilities, and not to facilities with contingency plans and spill­ prevention measures in place. (62) We should not propose broad changes to part 112 that would apply to all storage facilities regardless of tank size, without considering the potential impacts on navigable waters. However, the final rule should be flexible, and should account for site­ specific factors and conditions regarding potential environmental impacts. (114) Instead of imposing the same requirements on all facilities regardless of facility size or level of risk, we 23 should design a regulatory structure to impose pollution prevention costs equal to the pollution "costs" that a facility may impose on the public. (125) By imposing the same requirements and costs on smaller, lower risk facilities as on larger, higher risk facilities regulatory costs outweigh environmental benefits. (130) Large facilities, more stringent requirements. We should regulate large facilities more stringently because they can bear the cost of regulations more easily than smaller ones. (101) We should regulate large facilities more stringently than small facilities because large facilities pose a greater hazard to the environment than small facilities. We should modify SPCC regulations to reflect varying degrees of stringency based on facility size, and the observation that large facilities have a greater potential for causing spills and subsequent environmental damage. (32, 58, 65, 125) The proposed regulations "focus on aboveground storage tanks with a capacity of one million gallons and larger." (108, 122) Small facilities only. We should apply discretionary provisions to small facilities only, leaving requirements only for larger facilities. (51, 80, 103, L17) Small facilities, more stringent requirements. Small facilities may pose a greater spill potential because small facility owners or operators do not have resources to ensure proper equipment installation. (76) A large facility is more likely to have sufficient human resources and equipment than a small facility. In the event of a spill, a large facility can provide immediate response, thus minimizing the spill size. (102) Response: Large or small facility regulation, in general. We have decided not to regulate facilities differently based merely on storage capacity, provided that the capacity is above the regulatory threshold of over 1, 320 gallons. This decision is based on environmental reasons. Small discharges of any type of oil that reach the environment can cause significant harm. Sensitive environments, such as areas with diverse and/ or protected flora and fauna, are vulnerable to small spills. EPA noted in a recent denial of a petition for rulemaking: "Small spills of petroleum and vegetable oils and animal fats can cause significant environmental damage. Real­ world examples of oil spills demonstrate that spills of petroleum oils and vegetable oils and animal fats do occur and produce deleterious environmental effects. In some cases, small spills of vegetable oils can produce more environmental harm than numerous large spills of petroleum oils." 62 FR 54508, 54530, October 20, 1997. Describing the outcome of one small spill of 400 gallons of rapeseed oil into Vancouver Harbor, we noted that "... 88 oiled birds of 14 species were recovered after the spill, and half of them were dead. Oiled birds usually are not recovered for 3 days after a spill, when they become weakened enough to be captured. Of the survivors, half died during treatment. The number of casualties from the rapeseed oil spills was probably higher than the number of birds recovered, because heavily oiled birds sink and dying or dead birds are captured quickly by raptors and scavengers." 62 FR 54525. A small discharge may also cause harm to human health or life through threat of fire or explosion, or short­ or long­ term exposure to toxic components. 24 Other factors. Finally, EPA notes that the rule affords flexibility to an owner or operator of a facility to design a Plan based on his specific circumstances. It allows him to choose methods that best protect the environment. It permits deviations from most of the mandatory substantive requirements of the rule when the facility owner or operator can demonstrate a reason for nonconformance, and can provide equivalent environmental protection by other means. Consequently, both small and large facilities have the opportunity to reduce costs by alternative methods if they can maintain environmental protection. Because smaller facilities may require less complex plans than larger ones, their costs may be less. In addition, small facilities storing or using 1,320 gallons or oil or less will not be subject to the rule. III­ B­ 1 Defining "small" and "large" facility Comments: Alternate small facility definitions. Less than 126,000 gallons. Less than 126,000 gallons of total aboveground storage capacity. (133) Less than 30,000 gallons. Less than 30,000 gallons of total aboveground storage capacity. (82) Less than 10,000 gallons. Less than 10,000 gallons of total oil storage capacity. (L17). "Less than 42,000 gallons." Less than 42,000 gallons of total aboveground storage capacity (34, 67, 78, 133, and 167); less than 42,000 gallons of total oil storage capacity, provided no single tank is greater than 12,600 gallons (58); If we define a small facility as one with less than 42, 000 gallons of total aboveground storage capacity, we would reduce the burden on numerous small operations, without limiting the protection afforded by spill prevention, containment, and countermeasures. (78) Less than 42,000 gallons total storage capacity, provided no single container is greater than 250 gallons. (133) 242,000 gallons. We should define a small facility as a "facility with a total of 242,000 gallons or less of oil, provided no single container has [a] capacity in excess of 20,000 gallons." (70) Large facility definition. More than 10,000 gallons. A large facility should be one with a capacity of 10, 000 BBI (4. 2 million gallons). This approach would be more reasonable and would recognize the greater threat presented by a spill occurring at a facility with that amount of storage capacity. (34) More than 42,000 gallons. Supports the 42,000 gallon capacity criteria, but suggests that small and large facilities be further delineated. (62) We should 25 define a large facility as one with a regulated storage capacity of more than 42,000 gallons. (78,105) Response: Because we do not differentiate requirements merely due to facility size, there is no need to define large or small facility. III­ B­ 2 Small facility exemption Comments: Support for small facility exemption. We should exempt small facilities from this regulation. (28, 46, 58, 67, 70, 82, 101, 67) Such an exemption would be consistent with the Task Force findings. (28) An exemption would reduce the regulatory burdens because owners or operators would then be subject to local requirements. (46) We should exempt small facilities because we would realize a more significant environmental benefit from taxpayer's dollars by focusing scarce funds and resources on larger facilities. (58) In setting an exemption, we should consider size and whether the facility is one or more miles from surface waters or outside of the coastal zone. (167, 174) Opposition to proposal. We have not provided a "reasoned" analysis for applying the proposed revisions to small facilities. (58) We should gather additional information to justify our changes to the SPCC program. Cites the GAO report, and asserts that we need more information to decide which tanks to regulate most strictly and inspect most often. (101) We did not provide a historical background, or an understanding of exploration and production or gas processing industry spills. (114) Recommendations instead. Questions whether all of the proposed changes in the rule are necessary for all types and sizes of oil storage facilities, including smaller tank configurations such as those found at oil and gas production sites, quick oil change facilities, and other points of oil sales and distribution. (70) The newly proposed requirements should remain as recommendations for small facilities. (67, L18) Risk. The regulation should not focus on small, aboveground storage tanks, which pose fewer environmental risks than large tanks. (50, 67, 79) We should apply the revisions to large facilities only, and maintain the status quo for smaller, less environmentally threatening facilities. (58) The current SPCC regulations and industry standards provide sufficiently for continued environmental protection. (67) We should exempt certain smaller, low risk tanks and temporarily closed tanks. (71) We should exempt facilities that have no reasonable potential to discharge oil into navigable waters. (75) We should not require small facilities to have SPCC Plans, as long as the facility's HAZWOPER or hazardous waste contingency plan contains oil­ related spill response procedures. (62, 124) "Problems exist" in the proposed regulations, with respect to smaller aboveground tanks in the 660 to 10,000 gallon range capacity storage (108), and with smaller aboveground tanks in the 660 to 20,000 gallon range capacity storage (122). Storage tanks in the 600 to 4,200 gallon storage capacity range neither have 26 the same potential adverse impact nor require the same intense scrutiny as very large tanks. (105) Our data do not demonstrate that small facilities cause significant discharge hazards to navigable waters. (31, 34, 101, and 110) Small shop­ built containers. Smaller, factory­ constructed tanks have fewer field construction problems and hold less oil than large tanks. Eliminating small tanks from the proposed requirements would result in a more cost­ effective regulatory program with environmental protection equivalent to part 112 requirements. (164) Response: As noted in this section, we are not regulating small facilities differently from large facilities. See the discussion in section V ­ G of this document concerning the rise in the regulatory threshold. Recommendations instead. We are not including any recommendations in the rules because we do not wish to confuse the regulated public as to what is mandatory and what is discretionary. Risk. We do consider the size of a facility and whether its location gives rise to the reasonable possibility of discharge as described in §112. 1( b), for example the distance of the facility from the nearest navigable waters or adjoining shorelines. III­ B­ 3 Alternative regulatory approaches for small facilities Comments: Specific rules, production facilities. We should develop a subset of regulations to specifically address operations of small oil and gas production facilities with a storage capacity of less than 42,000 gallons. (28) Less than an SPCC Plan. Facilities with hundreds of small capacity storage tanks (50 barrels or less) should be required to meet spill prevention measures but not prepare an SPCC Plan, or meet the other requirements associated with the SPCC rules. The potential for major environmental damage from these facilities is remote because these facilities hold small volumes of oil. (71) Response: Specific rules, production facilities. Because we do not regulate facilities based on size, there is no need for regulations specifically addressed to any type of facility for that reason. We note that different sections of the final rule address production facilities. For example, §112. 9 addresses requirements for onshore production facilities. Section 112. 10 addresses requirements for onshore oil drilling and workover facilities. Section 112. 11 addresses requirements for offshore drilling, production, or workover facilities. Less than an SPCC Plan. We disagree that meeting the rule's requirements without preparing and implementing a Plan would protect the environment. There would be no way to enforce those requirements in the absence of a written facility­ specific Plan. Category IV: General applicability and notification 27 Category IV: General applicability and notification IV­ A: Scope of the rule ­ "Harmful quantities" ­ §112.1( a), (b), (c), and (d)( 1) Background: Section 112.1( a) of the current rule seeks to prevent oil discharges into the "navigable waters of the United States or adjoining shorelines." In §112.1( a), (b), and (c) of the 1991 proposed rule, we proposed to extend the geographic scope of the SPCC regulation to conform with the 1977 CWA amendments. CWA section 311( b)( 1), as amended in 1977, prohibits oil or hazardous substance discharges into United States navigable waters or adjoining shorelines, or into the waters of the contiguous zone, or in connection with activities under the Outer Continental Shelf Lands Act or the Deepwater Port Act of 1974, or that may affect natural resources belonging to, appertaining to, or under the exclusive management authority of the United States, including resources under the Magnuson Fishery Conservation and Management Act. We also proposed to revise the term harmful quantities in §112.1( b) to reflect the 1978 amendments to the CWA. The revised term – quantities that may be harmful, as described in part 110 of this chapter – includes oil discharged in quantities that violate applicable water quality standards, cause a film or sheen upon or discoloration of the surface of the water or adjoining shorelines, or cause a sludge or emulsion to be deposited beneath the surface of the water or upon adjoining shorelines. See 40 CFR 110.3. Amendments to the CWA also reflected the broadening of quantities that may be harmful to include those not only harmful to the "public health or welfare," but also to the environment. IV­ A­ 1 Extending the geographic scope of the rule Comments: NRDAs. Proposal "will allow for more clarity in determining which facilities are subject to the SPCC requirements. Also, the inclusion of natural resources sets the stage for the implementation of Natural Resources Damage Assessments, as required by OEPA." (27) Opposition to proposal. "If natural resources in this context means all Federal lands, then this extension would bring under the scope of 40 CFR 112 a significant number of operating facilities which did not previously require SPCC plans. The proposed rule, however, states that EPA assumes existing facilities that would be brought under 40 CFR 112 regulation already have SPCC Plans for other reasons, and thus expects the rule to affect only new facilities. This is incorrect; many existing facilities on federal lands do not have SPCC plans because they have had no need and no regulatory requirement for them. For example, our facilities in arid areas where there is little or no surface water or rainfall lack such plans because of their location and the nature of their activities. Thus, the regulations should be revised to better distinguish which existing or new facilities warrant SPCC plans based on their location and the nature of their activities." (63) 28 Coastal zone. Exclude. "... RMOGA suggests consideration be given to adding requirements that the exempt facilities be those located 1 or more mile( s) from surface waters (defined as those for which water quality standards are assigned) or those located outside of the coastal zone (as already defined by regulation)." (167) Include. "The suggested reference to the coastal zone is appropriate because this is a clearly defined area and is the area where greatest benefits from the proposed rules can be expected." Areas less than one mile from a river, lake or stream should be excluded from the coastal zone definition. (174) Magnuson Act resources only. Expansion of applicability to include natural resources "will surely result in another unnecessary workload on the judicial system over the years. Perhaps the replacement of this item with the following wording will minimize or eliminate the impact: `... or any resources under the Magnuson Fishery Conservation and Management Act'." (L12) Response: We also believe that few, if any, new facilities will be subject to the rule because of its extension to facilities with the potential to affect certain natural resources. We believe that most affected facilities are either already subject to the rule, or not subject to our jurisdiction due to a Memorandum of Understanding between EPA, the U. S. Department of Transportation (DOT), and the U. S. Department of the Interior (DOI), which assigns jurisdiction over most of those facilities to DOT or DOI. See 40 CFR part 112, Appendix B. We have amended this provision to be consistent with the revised statutory language found in sections 311( b)( 1) and (c)( 1)( A) of the CWA. This rule focuses on preventing discharges to navigable waters, adjoining shorelines, the exclusive economic zone, and natural resources belonging to, appertaining to, or under the exclusive jurisdiction of the United States. Once a prohibited discharge of oil occurs and affects such natural resources, the NRDA provisions of OPA sections 1002( b)( 2)( A) and 1006 apply. The National Oceanographic and Atmospheric Administration has promulgated a set of regulations which govern the process for conducting NRDAs under the OPA. 15 CFR part 990. IV­ A­ 2 Broadening the concept of harmful quantities Comments: Support for proposal. "Pratt & Whitney also agrees with the revision of section 112.1( b) definition of `harmful quantities' to reflect those of the Clean Water Act amendments. This effort at consistency helps business achieve compliance." (118) Opposition to proposal. Our proposal would "replace a fairly objective standard with a very subjective conditional standard," and asserted that the language in the current rule 29 provides adequate environmental protection. (35) We should expand the definition of a harmful quantity to include used oils or waste forms of all subject products. (87) One person asked that we describe how we will determine whether a quantity "may" be harmful, and who will make this determination. (111) While our proposed change implies a standard of reasonable risk, the applicable part 110 definition "creates an entirely different standard." Part 110 provides that any discharge that causes a film or sheen upon or discoloration of the surface of the water or adjoining shorelines is deemed to be a discharge of oil that "may be harmful." (125) We should modify the applicability standard to base the program on "real" or "reasonable" risks to navigable waters, rather than on "de minimis" or "theoretical" risks, to reduce the regulatory burden. (98, 125, 170) Facility notification. Our proposal would subject more owners or operators to the §112.1 notification requirements. (65, 98) Manmade structures. Our risk criteria in determining applicability to the SPCC requirements are too broad, particularly with regard to the sheen test and the "prohibition of considering manmade structures" to evaluate a facility's risk. (98) We should change the regulation to permit an owner or operator to consider manmade structures that provide containment in determining whether a facility could reasonably be expected to have a spill event. Such a consideration is appropriate "where the structures are inherent in the design of the facility and serve functional and operational purposes." (78, 98, 125, 156, 170) NPDES rules. Our definition of harmful quantities does not appear to reflect the National Pollutant Discharge Elimination System (NPDES) storm water discharge permit requirements. We should consider the protection provided by NPDES permits and the Underground Storage Tank (UST) regulation (part 280) sufficient. (76) Paperwork. Our proposal appears to conflict with section 101( f) of the Clean Water Act (CWA) that requires EPA to minimize paperwork, duplication, and delays in implementing the statute. (65) Reasonable expectation of discharge. We should clarify the statement in the proposed rule that part 112 applies to owners or operators of non­ transportation­ related facilities, "which due to their location could reasonably be expected to discharge oil in quantities that may be harmful, described in part 110." This is particularly important because of the associated penalties for noncompliance. (62, 89, 98, 111, 149, 154) Sheens. What makes a sheen harmful? (62) Response: Support for proposal. We appreciate commenter support. Applicability. Quantities of oil that may be harmful include oil discharged in quantities that violate applicable water quality standards, cause a film or sheen upon or discoloration of the surface of the water or adjoining shorelines, or cause a sludge or 30 emulsion to be deposited beneath the surface of the water or upon adjoining shorelines. The revision we have made to this provision simply reflects the 1978 amendment to the CWA, which requires us to determine quantities of oil that may be harmful, rather than quantities of oil that will be harmful. The harm a discharge may cause will vary from site to site depending upon, for example, the sensitivity of the environment, the water conditions, etc. These quantities apply to discharges of used oil or waste oil as well as any other type of oil. The 1987 amendments to part 110 incorporated this statutory change, but retained the same objective criteria as before – violation of applicable water quality standards, a film or sheen on the surface, or a sludge or emulsion below the surface. Thus, this revision to our SPCC rule should not result in a change in the number of regulated entities. Facility notification. We have withdrawn the proposal for facility notification. Manmade structures. To allow consideration of manmade structures (such as dikes, equipment, or other structures) to relieve a facility from being subject to the rule would defeat its preventive purpose. Because manmade structures may fail, thus putting the environment at risk in the event of a discharge, there is an unacceptable risk in using such structures to justify relieving a facility from the burden of preparing a prevention plan. Secondary containment structures should be part of the prevention plan. NPDES rules. We do consider the protection provided by NPDES permits and the Underground Storage Tank (UST) regulation (part 280) in the rule. An owner or operator may use his Best Management Practice Plan (BMP) prepared under an NPDES permit as an equivalent SPCC Plan, if the plan provides protections equivalent to SPCC Plans. Not all BMP plans will qualify, as some BMP plans might not provide equivalent protection. NPDES permits without BMP plans would not qualify. We exempt from the SPCC program completely buried tanks subject to all of the technical requirements of 40 CFR part 280 or a State program approved under 40 CFR part 281. Paperwork. We disagree that our proposal conflicts with section 101( f) of the Clean Water Act (CWA) that requires EPA to minimize paperwork, duplication, and delays in implementing the statute. The expansion of the geographical scope of the rule tracks the 1978 statutory amendments. Reasonable expectation of discharge. We do not believe that any rule which exempts facilities beyond any particular distance meets the intent of the statute. The locational standard in the rule is whether there is a reasonable possibility of discharge in quantities that may be harmful from the facility. A facility that is more than one mile from navigable waters might well fit within that standard. For example, piping or drainage from that facility might lead directly to navigable water. If discharged oil may reach or does reach navigable waters, adjoining shorelines, or protected resources, the distance which the discharged oil travels is irrelevant. 31 Sheens. See the discussion of the dangers of discharged oil under the discussion of the definition of "oil" in today's preamble. IV­ A­ 3 Electrical equipment Background: In the preamble to the 1991 proposal, we noted that certain facilities may have equipment such as electrical transformers that contain significant quantities of oil for equipment operation – not storage. We said that operational oil­ filled equipment should not be subject to §§ 112.8( c) or 112.9( d), which address bulk storage containers at onshore facilities. Consequently, an owner or operator of a facility with equipment containing oil for ancillary purposes need not provide secondary containment for this equipment nor implement the other provisions of proposed §§ 112. 8( c) or 112. 9( d). However, oil­ filled equipment must meet other applicable SPCC requirements, including the general requirements in §112.7 and 112.7( c), to provide appropriate containment and or diversionary structures to prevent discharged oil from reaching navigable waters. Comments: We should be consistent with the part 280 requirements, and exclude from part 112 electrical equipment that requires mineral oil to operate. Otherwise, we would be imposing a substantial regulatory burden on owners or operators. We excluded electrical equipment from part 280, rationalizing that these types of tank systems pose a relatively low level of risk compared to other types of storage tanks. Electrical substations and other installations are not facilities as defined in the proposed rule. Electrical equipment does not consume oil, and therefore is not covered under the SPCC program. (130, 138) Response: We disagree that oil­ filled electrical equipment, as well as other operational equipment, is not subject to the SPCC rule. We have amended §112.1( b) to clarify that using oil, for example operationally, may subject a facility to SPCC jurisdiction as along as the other applicability criteria apply, for example, oil storage capacity, or location. Such a facility might reasonably be expected to discharge oil as described in §112. 1( b). Therefore, the prevention of discharges from such facility falls within the scope of the statute. We also defined facility in the final rule to include equipment in which oil is used or stored. 32 IV ­ B: Exemption of completely buried containers ­ §112.1( d)( 2)( i) and (d)( 4) Background: Under §112.1( d)( 2)( i) and (ii) of the current rule, a facility with a completely buried storage capacity of 42,000 gallons or less of oil and with an aboveground storage capacity of 1,320 gallons or less of oil, provided no single container has a capacity in excess of 660 gallons, is exempted from the requirements of part 112. In §112.1( d)( 2)( i) of the 1991 proposal, we proposed to exclude the capacity of underground storage tanks (editorially changed to "completely buried tanks," as defined in §112.2) subject to all of the technical requirements of 40 CFR part 280. (Subterranean vaults, bunkered tanks, and partially buried tanks are considered aboveground storage containers for purposes of part 112. See the definition discussion in Category VI of this document.) We also proposed in §112.1( d)( 4) to exclude from part 112 applicability, completely buried tanks, subject to the technical requirements of part 280. Comments: Support for proposal. "We also support the exemption of the underground storage tanks that are subject to 40 CFR part 280. This will eliminate duplicate regulation of these tanks." (27,35, 53, 66, 67, 71, 75, 82, 92, 95, 102, 103, 106, 107 115, 118, 125, 133, 135, 136, 164, 173, 175, 182, 190, L24, L29) Consistency. We should be consistent in our approach to regulating ASTs and USTs. For example, under part 280, UST systems that store fuel solely for use by emergency power generators do not have to comply with the "release detection" requirements in part 280. Therefore, we should "defer AST systems that store fuel solely for use by emergency power generators from the listed secondary containment options." (69) Editorial suggestion. Supports the proposed exclusion of USTs from part 112, but we should include the provision in §112.1, rather than in the §112.2 definitions. (121) Equivalency. "EPA itself states that the UST program offers protection `equivalent' to that provided by the SPCC program. That being the case, EPA has every reason to avoid the confusion that would result as the regulated community implements a scheme under which it is difficult to determine the applicability of the regulation." (35, 57, 71, 173) Reduced paperwork. Supports proposal to exclude certain USTs from part 112 coverage and from the SPCC threshold calculation, because it would substantially decrease the amount of unnecessary paperwork that an owner or operator generates and that we review. (103) Opposition to proposal. Opposes the §112.1( d)( 2)( i) and (d)( 4) exclusions. (43, 44, 47, L4, L5) 33 Confusing. "...( T) he exemption of USTs regulated under 40 CFR 280 means that a facility owner may have some tanks that are exempt from SPCC requirements and some not. ... This could get really confusing!" (111) Costs. We should not exempt facilities with underground storage tank (UST) installations whose total capacity exceeds 42,000 gallons, because the rulemaking docket contained no economic justification for this and Congress enacted no law requiring the change. (43) Groundwater. "Exempting all combinations and sizes of USTS from the proposed Oil Pollution regulation in an effort to avoid overlapping federal rules may appear attractive in a paperwork reduction sense. But this regulatory approach does not consider some basic characteristics of the natural resource: groundwater eventually becomes surface water. Hydrologically, oil released into underground waters may migrate to surface water within minutes or months. Certain classes of USTs could seriously damage the nation's ground and surface water resources if an accident were to occur in the absence of emergency responsive provisions." Urges no further action "until further legislative remedies are in place." (L4) UST rules insufficient. UST regulations are insufficient to protect navigable waters from oil discharges. The part 280 requirements lack adequate emergency response, training, contingency planning, recordkeeping, and spill prevention planning requirements, diking of fuel transfer areas; fuel transfer area operational procedures, illumination of fuel transfer areas; storm water drainage system design; posting of vehicle weight restrictions in areas where there is underground piping and/ or design of underground piping to withstand vehicular loadings; or a requirement for an application of "good engineering practice." (24, 43, 44, L4) "Also, response actions for underground storage tanks leaks should remain part of the written SPCC Plan." (27) An owner or operator of a tank system subject to part 280 does not have to comply with the part 280 release detection requirements. Under the 1991 proposal, these owners or operators would not have to prepare an SPCC Plan or install release detection systems. (76) The leak detection and tank installation requirements for buried tanks should be consistent with part 280. (111) "The Agency should not hold a position that UST program regulation of those facilities would satisfy the spill prevention requirements of 40 CFR 112." (L5) Emergency response. "Certain classes of USTs could seriously damage the nation's ground and surface water resources if an accident were to occur in the absence of emergency responsive provisions." (L4) PE certification. "...( T) he UST regulation does not require the development and certification of spill prevention plans as is required under Oil Pollution Act regulations." (L4) 34 Applicability. Piping. "Under the proposed rule, it is unclear whether or to what extent the piping connecting USTs and ASTs in such circumstances is regulated under the SPCC program. If such piping is subject to the leak detection requirements for USTs under 40 CFR part 280, then ILMA believes the piping should remain exclusively within the jurisdiction of the UST program and should be exempted from the SPCC regulations." (48) Partially buried tanks and bunkered tanks. "Bunkered tanks and partially buried tanks should be covered by the UST program since ten percent or more of the product is below grade either in the tank or pipeline. Tanks under the UST program should be adequately protected to prevent and minimize releases to the environment. Tanks not covered by the UST program should be considered aboveground storage tanks (provided that they are not permanently closed) for purposes of the SPCC regulation and should b subject to the requirements." (190) Clarification. Proposed §112.1( d)( 2)( i) is confusing. Asks whether it is coverage by part 280 that permits an owner or operator to exclude the capacity of a buried tank from the 42,000 gallon threshold, or the lack of such coverage. (28, 31, 165, L15) Definitions. "EPA should devise a regulatory scheme under which the same definition of underground storage tanks is used in the UST and SPCC regulatory programs...." (57) Delegation. We should consider implementing a program for ASTs similar to the UST program. The UST program, which "franchises" programs to the States, provides a flexible approach to enable and encourage States to carry out delegated program activities. (111) "In compliance with." We should change proposed §112.1( d)( 2)( i) and( d)( 4) to state that we exclude owners or operators of USTs in compliance with the technical requirements of part 280, rather than excluding owners or operators of USTs subject to the part 280 technical requirements. (76) Outreach. We should design and implement an outreach program based on the UST program's outreach efforts to give owners or operators time to learn about the program and to prepare and implement an SPCC Plan before the regulatory compliance deadlines. (L6) Response: Support for proposal. We appreciate commenter support. In response to the commenter who said that we should exclude USTs through a provision in §112.1, rather than through the §112.2 definitions, we agree. That is exactly the action we proposed and adopted. 35 Regulatory jurisdiction. To eliminate any possible confusion over regulatory jurisdiction, we explain in today's preamble (see the above background discussion) which containers in a facility are subject to 40 CFR part 280 or a State program approved under 40 CFR part 281, and which are subject to part 112. Opposition to proposal. Discretionary authority. Today's rule (see §112.1( f) in today's preamble and section 2 of the 1993 Comment Response Document) provides the Regional Administrator with the authority to require any facility subject to EPA jurisdiction under section 311 of the CWA, regardless of threshold or other regulatory exemption, to prepare and implement an SPCC Plan when necessary to further purposes of the Act. UST rules insufficient. As we noted in the preamble discussion of §112.1( d)( 1)( i), the UST program provides comparable environmental protection to the SPCC program. While not all aspects of the programs are identical, the UST program ensures protection against discharges as described in §112.1( b), and protection of the environment. Therefore, dual regulation is unnecessary. In response to commenters asserting that UST rules lack provisions concerning contingency planning; emergency response; certain recordkeeping requirements; and other alleged deficiencies, we disagree. The UST rules have numerous safeguards addressing the commenter's issues. Contingency planning. While it is true that UST rules do not require contingency planning, spills and overfills of USTs resulting in a discharge to the environment are much less likely as a result of those rules. An owner or operator of an underground storage tank subject to 40 CFR part 280 or a State program approved under 40 CFR part 281 was required to install spill and overfill prevention equipment no later than December 22, 1998. 40 CFR 280.20 and 280.21. The use of this equipment will greatly reduce the likelihood of both small and large releases or discharges of petroleum to the environment through surface spills or overfilling underground storage tanks. In addition, the UST rules place a general responsibility on the owner or operator to ensure that discharges due to spilling and overfilling do not occur. See 40 CFR 280.30. Emergency response and release reporting. The UST rules also have several requirements related to emergency response and release or discharge reporting. The UST rules generally require that releases of regulated substances be reported to the implementing agency within 24 hours. As part of the initial response requirements (found at 40 CFR 280.61), an owner or operator must take immediate action to prevent further release of the regulated substance and must identify and mitigate fire, explosion, and vapor hazards. Reporting and recordkeeping. In addition to the reporting requirements mentioned above, there are numerous reporting and recordkeeping 36 requirements in the rules governing underground storage tanks. Among these are: corrective action plans; documentation of corrosion protection equipment; documentation of UST system repairs; and, information concerning recent compliance with release detection requirements. Thus, the UST rules have significant reporting and recordkeeping requirements, including specific requirements related to spills and overfills. Transportation rules. In addition to the EPA UST rules, the U. S. Department of Transportation has hazardous material regulations related to driver training, emergency preparation, and incident reporting and emergency response. Training regulations, for example, can be found at 49 CFR part 172, and loading and unloading regulations can be found at 49 CFR 177.834 and 49 CFR 177.837. These regulations apply, for example, to truck drivers delivering gasoline or diesel fuel to gas stations with underground storage tanks. Piping, ancillary equipment, and containment systems. EPA has modified the scope of the proposed exemption for completely buried tanks (which are excluded from the scope of the SPCC rule if they are subject to all of the technical requirements of 40 CFR part 280 or a State program approved under 40 CFR part 281) by clarifying that the exemption includes the connected underground piping, underground ancillary equipment, and containment systems, in addition to the tank itself. This modification is consistent with the definition of underground storage tank system found at 40 CFR 280.12. In addition, this clarification is responsive to the comment which asked that the piping be included in the exemption. Clarification. We disagree that §112.1( d)( 2)( i) is confusing. If a completely buried tank is subject to all of the technical requirements of 40 CFR part 280 or a State program approved under 40 CFR part 281, it is exempt from the SPCC rule. Otherwise, it may be subject to the rule. Delegation. We have no authority under the Clean Water Act to delegate our program to the States, unlike the UST program. However, States may enact their own prevention programs. The Act does not preempt States from doing so. "In compliance with." We disagree that we should change §112.1( d)( 2)( i) and( d)( 4) to exclude an owner or operator of a facility with completely buried tanks in compliance with the technical requirements of part 280 (or a State program approved under part 281), rather than subject to part 280 (or part 281) technical requirements. Regulatory jurisdiction would be chaotic under a scheme measuring compliance. A facility might be in compliance one day and not the next, subjecting the facility to dual regulation. Outreach. We agree that outreach is necessary and will conduct extensive outreach efforts after publication of this rule. 37 Partially buried tanks and bunkered tanks. We disagree that partially buried tanks and bunkered tanks should be considered completely buried tanks, and therefore excluded from SPCC provisions. Such tanks may suffer damage caused by differential corrosion of buried and non­ buried surfaces greater than completely buried tanks, which could cause a discharge as described in §112.1( b). Such tanks are also not subject to secondary containment requirements under part 280 or a State program approved under 40 CFR part 281. There may also be accidents during loading or unloading operations, or overfills resulting in a discharge to navigable waters and adjoining shorelines. Furthermore, a failure of such a tank (caused by accident or vandalism) would be more likely to cause a discharge as described in §112.1( b). Therefore, these tanks must be regulated under the SPCC program. We will, however, accept UST program forms, e. g., the Notification for Underground Storage Tanks, EPA Form 7530­ 1, or an approved State program equivalent, insofar as such form contains information relevant to the SPCC program. For example, the UST form contains information regarding corrosion protection for steel tanks and steel piping (item 12) which would be relevant for SPCC purposes. Other items on the form may also be relevant for SPCC purposes. Effect on Facility Response Plan facilities. The exemption for completely buried tanks subject to all the technical requirements of 40 CFR part 280 or a State program approved under 40 CFR part 281 applies to the calculation of storage capacity both for SPCC purposes and for Facility Response Plan (FRP) purposes because the exemption applies to all of part 112. Therefore, a few FRP facilities with large capacity completely buried tanks subject to 40 CFR part 280 or a State program approved under 40 CFR part 281 might no longer be required to have FRPs. Calculations for planning levels for worst case discharges will also be affected. However, the Regional Administrator retains authority to require the owner or operator of any nontransportation related onshore facility to prepare and submit a FRP after considering the factors listed in §112.20( f)( 2). See §112.20( b)( 1). IV­ B­ 1 Completely buried tanks regulated under State programs Comments: "Although certain USTs such as heating oil tanks are deferred or exempted, because of concern for the environment and/ or more stringent state regulations, these USTs may incorporate all of the technical requirements of the fully regulated USTs. If owners having exempted or deferred USTs take the necessary action to comply with the UST technical requirements, these USTs should likewise be excluded from 40 CFR 112 requirements." (79) Response: We agree, and have revised the rule accordingly. In §112.1( d)( 4) of the final rule, we exempt from part 112 requirements (except the facility diagram) completely buried tanks subject to all of the technical requirements of State programs approved under part 281. When we proposed the part 280 exemption in 1991, few if any States had an approved program. In 40 CFR part 281 (published on September 23, 1988 at 53 FR 37212), EPA established regulations whereby a State could receive 38 EPA approval for its State program to operate in lieu of the Federal program. In order to obtain EPA program approval under part 281, a State program must demonstrate that its requirements are no less stringent than the corresponding Federal regulations set forth in part 280, and that it provides adequate enforcement of these requirements. Thus, we have decided to exempt also the storage capacity of USTs subject to all of the technical requirements of State UST programs which EPA has approved. By January 2000, EPA had approved 27 State programs, plus programs in the District of Columbia and Puerto Rico. The rationale for exempting the storage capacity of these facilities from the SPCC regime is because 40 CFR part 280 and the approved State programs under 40 CFR part 281 provide comparable environmental protection for the purpose of preventing discharges as described in §112.1( b). IV­ B­ 2 Editorial changes and clarifications Comments: Piping, ancillary equipment, and containment systems. It is unclear how part 112 addresses piping that connects USTs to aboveground storage tanks (ASTs); we should exclude from part 112 regulation, piping subject to part 280 leak detection requirements. (48) Proposed §112.1( d) is unclear. (111) Editorial reference. In proposed §112.1( d), our reference to the "first sentence of §112.7( a)( 3)," appears to be incorrect. (16) Response: Piping, ancillary equipment, and containment systems. EPA has modified the scope of the proposed exemption for completely buried tanks (which are excluded from the scope of the SPCC rule if they are subject to all of the technical requirements of 40 CFR part 280 or a State program approved under 40 CFR part 281) by clarifying that the exemption includes the connected underground piping, underground ancillary equipment, and containment systems, in addition to the tank itself. This modification is consistent with the definition of underground storage tank system found at 40 CFR 280.12. In addition, this clarification is responsive to the comment which asked that the piping be included in the exemption. Editorial reference. We disagree that our reference to §112.7( a)( 3) in the proposed introductory paragraph of §112.1( d) is incorrect. However, we have removed the §112.7( a)( 3) reference in introductory paragraph of §112.1( d) and placed it instead in §112.( d)( 4). We thus clarify that regardless of whether a completely buried tank is excluded from part 112, the owner or operator must mark such tank on the facility diagram, if the facility is otherwise subject to part 112. (See Category X­ C of this document for further discussion on facility diagrams.) IV ­ C: Exemption of permanently closed containers ­ §112.1( b)( 2) and (d)( 2)( ii) See also section V­ 11, definition of "permanently closed.") Background: Section 112.1( b) establishes the general applicability of part 112. In 1991, in §112.1( b)( 2), we proposed that part 112 would apply to a facility with a 39 container used for standby storage, seasonal storage, or temporary storage, or not otherwise permanently closed (as defined in §112.2). Current §112. 1( d) describes the facilities excluded from part 112. In 1991, in §112.1( d)( 2)( i) and (ii), we proposed that the facility threshold storage capacity would not include the capacity of underground storage tanks that are permanently closed (as defined in §112.2). Comments: Support for proposal. "We agree that storage tanks which meet the criteria for being permanently closed ... should be exempt from 40 CFR part 112. We believe that these tanks, when properly and permanently closed, pose no danger to the public health or the environment." (23, 36, 72, 75, 86, 90, 95, 102, 103, 118, 175, 190, L12, L24, L29) Decommission. "Because `recommissioning' of a tank requires that the Plan be amended, the need for the definition would not appear to be necessary if the wording was changed to decommission instead of permanently closed. This would provide the facility operator more flexibility without a reduction in the protection afforded." (76) Non­ oil storage. "Any regulations should recognize that a tank does not have to be empty of all products, only oil products, to be considered `permanently closed' from the standpoint of this regulation." (51) Tanks, not facilities. We should exclude from SPCC Plan requirements permanently closed tanks "rather than facilities where all tanks are closed." (L24) Temporary closure. "Pennzoil has several oil production sites where we have ceased production, but not permanently closed the site, pending more favorable economics to restart production. Under this proposal, it appears that we would have to either permanently close the unused tanks (at a cost of $450 to $1500 per tank) and then pay to reopen the tanks or prepare SPCC plans for empty tanks. Both of these alternatives seem unnecessary to us. ... Pennzoil suggests that instead the capacity of these tanks not be included, provided the operator can show that the tanks have been shut­ in and all fluid removed down to the pipeline connection." (71,107) Emergency response. "...( T) he requirements for advance notification, and various construction and operating procedures are neither appropriate nor practical for temporary storage during a spill response effort." Therefore, suggests we "exempt from the Proposed Rule temporary storage facilities used in an emergency response." (60, 75, 103) Frac tanks. "...( U) nless language were added to exclude fractionization tanks from the SPCC program, each time a frac tank is used or moved to a new location, a modification to the facility­ specific SPCC plan would be required per 112.5( a). Frac tanks are often used to store oil for short periods of time while maintenance or workover operations are underway. The use of frac tanks is of 40 very short duration and does not necessarily increase the potential for a discharge." (167) Mining operations. "Once again, an interpretation covering drums for temporary storage poses severe practical problems for PDC, where one or two oil drums might be temporarily located at remote portions of a large mining operation, and it is impractical to maintain an up­ to­ date SPCC plan that addresses such drum storage and use." (L24) Sludge. "EPA should allow tanks which are `temporarily closed' (i. e., have no free product, but contain an oil sludge) to be exempt from the operational and design requirements of these regulations." (L2) Who determines permanent closure. "Within its definition of `permanently closed' (relative to tanks) the proposed rule would designate a number of conditions that must be met by the facility. DuPont believes that the imposition of such conditions is unnecessary and the designation of `permanently closed' should be left to the facility. Facilities are liable for the release of oil and must keep plans up to date for any component of the facility which could release oil." (155) Response: Support for proposal. We appreciate commenter support. Decommission. We disagree that the need for the definition is unnecessary if the wording were changed from permanently closed to decommission. A tank that is "decommissioned" might not meet the standards for permanent closure in the rule. Non­ oil storage. Containers storing products which are not oil are not subject to the SPCC rule. Temporary closure. If a tank is not permanently closed, it is still available for storage and the possibility of a discharge as described in §112. 1( b), remains. A tank closed for a temporary period of time may contain oil mixed with sludge or residues of product which could be discharged. A discharge from such facility could cause severe environmental damage. Therefore, it must remain subject to the rule. Nor does a short time period of storage eliminate the possibility of such a discharge. We agree that we should exclude permanently closed containers from Plan requirements, and have revised §112.1( b)( 3), (d)( 2)( i), and (d)( 2)( ii) to provide that permanently closed containers are excluded from part 112 requirements. A facility that contains only permanently closed containers is no longer subject to SPCC requirements. Who determines permanent closure. We disagree that we should allow the owner or operator to designate which containers are permanently closed. We believe that a definition is necessary based on objective requirements to avoid confusion as to when 41 we consider a container permanently closed. Therefore, we have promulgated a definition of permanently closed. See §112.2. IV ­ D: Exemption of Minerals Management Service (MMS) facilities ­ §112.1( d)( 3) Background: In §112.1( d)( 3) of the 1991 proposal, we proposed to exempt from the SPCC regulation facilities subject to regulation under the United States Department of Interior's (DOI's) Minerals Management Service (MMS) Operating Orders, notices, and regulations. In general, these facilities are offshore oil production or exploration facilities. We proposed this exemption to avoid redundancy in regulation. Under section 2( b)( 1) of Executive Order (EO) 12777, the President delegated authority to various Executive Branch agencies to regulate entities covered under the CWA. See 56 FR 54747, October 22, 1991. The EO gave EPA the authority to regulate nontransportation related onshore oil facilities. The President delegated similar authority over transportation­ related onshore facilities, deepwater ports, and vessels to the United States Department of Transportation (DOT); and authority over other offshore facilities, including associated pipelines, to DOI. Before EO 12777, MMS regulated facilities on the Outer Continental Shelf (OCS) (i. e., three miles or more beyond the coast line). EO 12777 gave DOI authority for spill prevention, control, and countermeasure planning for all offshore facilities, including some facilities traditionally subject to our jurisdiction. In a Memorandum of Understanding (MOU) between DOI, DOT, and EPA, effective on February 3, 1994, DOI redelegated to EPA the responsibility for regulating nontransportation related offshore facilities located landward of the coast line. This MOU is found in Appendix B of the current rule. As a result of this redelegation, offshore facilities landward of the coast line remain subject to our jurisdiction. Offshore facilities seaward of the coast line are subject to DOI jurisdiction, except for deepwater ports and associated pipelines delegated to DOT. Comments: Support for proposal. "The proposed revision regarding SPCC plans in the OCS is welcome. Considerable confusion regarding the need of both an SPCC plan and a MMS Spill Contingency plan exists." "The existing provisions of the MMS regarding oil spill prevention and contingency planning are comprehensive and provide a level of protection equivalent to that envisioned by EPA's proposed rules." (67, 75, 97, 110, 113, 133, 173, L12) Opposition to proposal. "...( W) e are concerned with MMS' `historic treatment of identified violations. ' MMS failed to issue a single civil penalty since 1982. The EPA, with its mechanism and authority to impose civil penalties, should not exempt offshore oil exploration and production from the requirements of the proposed regulation. Such action would surely result in better protection of the environment." (123, 142, L13) "More stringent." The more stringent of EPA or MMS regulations should take precedence. (L13) 42 Clarification. Asks which agency – EPA, DOI, or DOT – now has authority under section 311( j) of the CWA over "a portable drilling unit operating in the bed of an intermittent stream in New Mexico." (121) Response: Support for proposal. We appreciate commenter support. We have retained our original proposal, except for an editorial revision, because we believe that MMS will provide equivalent environmental protection for the facilities under its jurisdiction. MMS regulations require adequate spill prevention, control, and countermeasures that are directed more specifically to the facilities subject to MMS requirements. In response to the commenter concerned about MMS' enforcement record, as we noted in the 1991 Preamble, we believe that, based on an analysis of the MMS regulations (formerly known as Operating Orders), MMS requires adequate spill prevention, control, and countermeasure practices. "More stringent." We disagree that the more stringent of rules should take precedence unless the facility is a complex. If the facility is not a complex, then the rules of the agency with jurisdiction apply. Clarification. To determine which Federal agency has authority over a particular type of facility, we refer the reader to Appendix B of part 112. A portable drilling unit operating in the bed of an intermittent stream would be under EPA jurisdiction, assuming it met the regulatory threshold and that there is a reasonable possibility of a discharge as described in §112. 1( b) from the facility. The MOU between DOI, DOT, and EPA in Appendix B provides that we have authority to regulate non­ transportation­ related offshore facilities located landward of the coast line. The MOU in Appendix A defines non­ transportation­ related and transportation­ related onshore and offshore facilities. It defines a mobile oil well drilling facility as non­ transportation­ related when fixed in position for drilling operations. See 35 FR 11677, July 22, 1970. IV ­ E: Regulatory threshold ­ §112.1( d)( 2) Background: Section 112.1( d)( 2) contains the regulatory threshold provisions of part 112. Comments: Regulatory threshold. The threshold capacity criteria should be higher. The provision would regulate a universe of small facilities that pose no significant risk to navigable waters. (41, 125, 130, 189) Re proposed §112.1( d)( 2)( i), "We do not believe EPA intended to exempt solely those facilities meeting both of the above criteria. Instead, it would appear EPA intended this to be a `small entity' exemption." Suggests replacing the word "both" with "either" in introductory language to paragraph (2). (33) Our "all­ encompassing" approach would subject tens of thousands of aboveground tanks to the SPCC rule ­­ from small production tanks to large storage facilities at a refinery or a terminal facility. (71, 78) 43 Effectiveness and enforcement. "PEO feels that the inclusion of these excessively small facilities dilute the effectiveness of the program and the enforcement of larger facilities which pose a genuine threat." (41) Response: Regulatory threshold. We agree that the threshold should be higher. We have decided to raise the current regulatory threshold, as discussed in the 1997 preamble, to an aggregate threshold of over 1, 320 gallons. We believe that raising the regulatory threshold is justified because our Survey of Oil Storage Facilities (published in July 1996, and available on our web site at www. epa. gov/ oilspill) points to the conclusion that several facility characteristics can affect the chances of a discharge. First, the Survey showed that as the total storage capacity increases, so does the propensity to discharge, the severity of the discharge, and the costs of cleanup. Likewise, the Survey also pointed out that as the number of tanks increases, so does the propensity to discharge, the severity of the discharge, and the costs of cleanup. Finally, the Survey showed that as annual throughput increases, so does the propensity to discharge, the severity of the discharge, and, to a lesser extent, the costs of the cleanup. The threshold change will have several benefits. The threshold increase will result in a substantial reduction in information collection. Some smaller facilities will no longer have to bear the costs of an SPCC Plan. EPA will be better able to focus its regulatory oversight on facilities that pose a greater likelihood of a discharge as described in §112.1( b), and a greater potential for injury to the environment if a discharge as described in §112.1( b) results. We raise the regulatory threshold realizing that discharges as described in §112.1( b) from small facilities may be harmful, depending on the surrounding environment. Among the factors remaining to mitigate any potential disasters are that small facilities no longer required to have SPCC Plans are still liable for cleanup costs and damages from discharges as described in §112. 1( b). We encourage those facilities exempted from today's rule to maintain SPCC Plans. Likewise, we encourage facilities becoming operable in the future with storage or use capacity below the regulatory threshold which are exempted from the rule to develop Plans. We believe that SPCC Plans have utility and benefit for both the facility and the environment. While we believe that the Federal oil program is best focused on larger risks, State, local, or tribal governments may still decide that smaller facilities warrant regulation under their own authorities. In accord with this philosophy, we note that this Federal exemption may not relieve all exempted facilities from Plan requirements because some States, local, or tribal governments may still require such facilities to have Plans. While we are aware that some States, local, or tribal governments have laws or policies allowing them to set requirements no more stringent than Federal requirements, we encourage States, local, or tribal governments to maintain or lower regulatory thresholds to include facilities no longer covered by Federal rules where their own laws or policies allow. We believe CWA section 311( o) authorizes States to 44 establish their own oil spill prevention programs which can be more stringent than EPA's program. When a particular facility that is below today's threshold becomes a hazard to the environment because of its practices, or when needed for other reasons to carry out the Clean Water Act, the Regional Administrator may, under a new rule provision, require that facility to prepare and implement an SPCC Plan. See §112. 1( f). This provision acts as a safeguard to an environmental threat from any exempted facility. IV­ E( 1)­ 1 Alternative thresholds and criteria Comments: Alternatives suggested. We should increase the capacity criterion to a number that would better reflect facilities that pose a significant risk. (41, 49) 100 gallons. "If EPA insists on promulgating the proposed regulations, then there is no justification for excluding residential fuel oil storage tanks. ... A threshold of 100 gallons should be established to include all tanks which threaten the environment." (110) 2,000 gallons. 2,000 gallons or less, provided no single container has more than 1,100 gallons. (178) 6,000 gallons. 6,000 gallons or less of aboveground storage capacity, provided tanks have secondary containment and overfill protection (79) 10,000 gallons. 10,000 gallons or less of aggregate storage capacity, provided tanks have adequate secondary containment (L17); The regulation should apply only to facilities with capacity greater than 10, 000 gallons, based on individual unit size rather than accumulated volume. (L20) 30,000 gallons. 30,000 gallons or less, provided no single container has more than 15,000 gallons (82); 10,000 gallons or less of aggregate storage capacity (125, 130,170, 189, and L18). 42,000 gallons. (23, 58, 65, 78, 80, 82, 101, 103, 109, 116, 140, 164, 175, 183, and L6) 42,000 gallons or less, provided no single container has capacity in excess of 10,000 gallons. (70) Suggests different storage capacity levels, claiming that we chose 42,000 gallons arbitrarily. (42, 102, 143, 155, 182, 190) In choosing the threshold level, we should consider a facility's proximity to navigable water or environmentally sensitive areas. This commenter also stated that we should consider a facility's use of good engineering practice in revising the regulation. (159) 50,000 gallons ­ underground storage. "Many of our service stations have storage tanks for gasoline and diesel fuel of 12,000 gallons a piece. If all four products are provided at a station ­ as most are – our service stations will come 45 under the requirements for SPCC Plans. We do not believe that this is intended, and would request that the gallonage requirement be increased to 50,000, not 42,000 gallons." (177) Animal fats, vegetable oils. "Arvin is of the opinion that non­ petroleum based oils such as animal and vegetable fats and oils should be exempt from all oil 40 CFR 112 requirements." "The statutory history of the spill control program, as well as the content of the proposed regulations, make it clear that this program was conceived and designed to prevent and manage spills involving petroleum­ based oils. ... We therefore urge that the final regulations make clear that mandatory requirements are not applicable to facilities producing or storing vegetable oils." (56, 137, 162) Appalachian producers. The proposed requirements would be detrimental to Appalachian Producers, and we should exempt Appalachian Producers from any further requirements. (101) Electrical equipment. "The Agency should change the aboveground storage capacity criterion to limit the applicability of the SPCC requirements to facilities with one or more aboveground oil­ containing units with a capacity of more than 10,000 gallons and to limit the applicability of the SPCC requirements at such facilities to aboveground tanks or containers with a capacity in excess of 660 gallons and electrical equipment with aboveground capacity in excess of 10,000 gallons. To the extent that electrical equipment is not otherwise excluded from regulation under the SPCC program, the Agency should conditionally exclude all such equipment with a capacity of 42,000 gallons or less from regulation unless the unit of equipment has experienced one or more spill events." (125) Farms. "Placing unreasonable and expensive restrictions on on­ farm storage poses substantial risk to the farmer's ability to continue mechanized farming operations. We have not seen any big rush of city folks clamoring to do hand labor in the fields of this nation. Therefore, we request a reasonably crafted farm exemption from the aboveground tank rules, based on tank size and risk, such as is contained in the current underground storage tank regulations." (73, 106, L23) Floating fuel tanks. "It would be extremely helpful ... if the rule specifically addressed floating fuel storage, and the subjects of tank testing and diking and/ or containment." (151) Largest unit. The risk posed by a facility is more accurately measured by the size of the largest individual unit at the facility rather than the facility's aggregate storage capacity. The failure of one unit is extremely unlikely to cause failure of another unit because small tanks are rarely interconnected. (125) No threshold. We should focus on setting applicability criteria by tank size, rather than facility storage capacity. (67) We should omit the capacity criterion for total storage capacity at a facility. (170, 189) 46 Oil­ filled equipment, test tanks. We should exempt test tanks and certain oil­ filled equipment from part 112 because test tanks do not store oil in bulk, and are not intended to be oil­ filled. Test tanks could not "reasonably be expected to discharge oil in quantities that may be harmful." (60) Oil­ water separators. Part 112 should include facilities that have oil­ water separators connected to sanitary or storm water sewers or drains. Oil­ water separators are not subject to part 280 regulations, because they are "flow­ through process tanks." (43) Stripper oil and gas facilities. We should exempt stripper oil and gas well facilities from any new regulatory program. (113) Treatment tanks. We should exclude facility storage and treatment tanks associated with "non­ contact cooling water systems," or "storm water retention and treatment systems." Although the tanks are designed to remove spilled oil from manufacturing operations and parking lot runoff, the tanks contain insignificant concentrations of oil in the water. (90) Vaulted tanks. "We would ask that the proposed rule be amended to either exempt vaulted tanks under 3000 gallons, or tanks located inside a facility with adequate secondary containment, or reduce the requirements commensurate with the risk, i. e., the size and location of the tank. ... We request that vaulted tanks or tanks with other engineering controls designed to contain product released from failure or overfill, or which meet the technical requirements of 40 CFR part 280, be exempted from these regulations. We base this request on the fact that we employ containment and controls designed to prevent our stored product from reaching either soil or water. We provide for containment and notification upon product release." (1, 37, 49, 50, 65, 67, 72, 85, 133, 144) Volume, not capacity. "The 42,000 gallon capacity criteria is good, but CMI suggests that a further delineation separate large and small facilities. For example, the amount of oil actually stored in a tank. Can manufacturers have large tanks, but the amount of oil varies greatly, normally only from 10 to 50 percent oil are contained in the tank." (62) We should change the aboveground storage capacity threshold calculation to an aboveground oil storage volume calculation, so that an owner or operator would count the amount of oil in the storage container. (35, 167) We should change this threshold calculation to a working capacity calculation, so that an owner or operator would only count the amount of tank capacity actually used for storage. (31, 86, and 160) Response: As explained above (see section V­ E of this document), we have raised the regulatory threshold for aboveground storage capacity to over 1,320 gallons. All containers. In response to comments, we are including a minimum container size to use for calculation of the capacity of aboveground storage tanks and completely buried containers. The 55­ gallon container is the most widely used commercial bulk 47 container, and these containers are easily counted. Containers below 55 gallons in capacity are typically end­ use consumer containers. Fifty­ five gallon containers are also the lowest size bulk container that can be handled by a human. Containers above that size typically require equipment for movement and handling. We considered a minimum container size of one barrel. However, a barrel or 42 gallons is a common volumetric measurement size for oil, but is not a common container size. Therefore, it would not be appropriate to institute a 42 gallon minimum container size. You need only count containers of 55 gallons or greater in the calculation of the regulatory threshold. You need not count containers, like pints, quarts, and small pails, which have a storage capacity of less than 55 gallons. Some SPCC facilities might therefore drop out of the regulated universe of facilities. You should note, however, that EPA retains authority to require any facility subject to its jurisdiction under section 311( j) of the CWA to prepare and implement an SPCC Plan, or applicable part, to carry out the purposes of the Act. While some commenters had suggested a higher threshold level, we believe that inclusion of containers of 55 gallons or greater within the calculation for the regulatory threshold is necessary to ensure environmental protection. If we finalized a higher minimum size, the result in some cases would be large amounts of aggregate capacity that would not be counted for SPCC purposes, and would therefore be unregulated, posing a threat to the environment. We believe that it is not necessary to apply SPCC or FRP rules requiring measures like secondary containment, inspections, or integrity testing, to containers smaller than 55 gallons storing oil because a discharge from these containers generally poses a smaller risk to the environment. Furthermore, compliance with the rules for these containers could be extremely burdensome for an owner or operator and could upset manufacturing operations, while providing little or no significant increase in protection of human health or the environment. Many of these smaller containers are constantly being emptied, replaced, and relocated so that serious corrosion will likely soon be detected and undetected leaks become highly unlikely. While we realize that small discharges may harm the environment, depending on where and when the discharge occurs, we believe that this measure will allow facilities to concentrate on the prevention and containment of discharges of oil from those sources most likely to present a more significant risk to human health and the environment. Animal fats, vegetable oils. A facility storing or using animal fats or vegetable oils (whether edible or not) is subject to part 112 if there is a reasonable possibility of discharge as described in §112. 1( b) from such facility, and the facility meets regulatory threshold criteria. The scope of the rule encompasses all types of oils, not merely petroleum oil. In 1995, Congress enacted the Edible Oil Regulatory Reform Act (EORRA), 33 U. S. C. 2720. That statute mandates that most Federal agencies differentiate between and establish separate classes for various types of oils, specifically: animal fats and oils and greases, and fish and marine mammal oils; oils of vegetable origin; petroleum oils, 48 and other non­ petroleum oils and greases. In differentiating between these classes of oils, Federal agencies are directed to consider differences in the physical, chemical, biological, and other properties, and in the environmental effects, of the classes. In response to EORRA, as noted above, we have divided the requirements of the rule by subparts for facilities storing or using the various classes of oils listed in that act. Because at the present time EPA has not proposed differentiated SPCC requirements for public notice and comment, the requirements for facilities storing or using all classes of oil will remain the same. However, we have published an advance notice of proposed rulemaking seeking comments on how we might differentiate among the requirements for the facilities storing or using various classes of oil. 64 FR 17227, April 8, 1999. If after considering these comments, there is adequate justification for differentiation among the requirements for those facilities, we will propose rule changes. Appalachian producers, small facilities, stripper oil and gas facilities, oil­ water separators. The "storage capacity" definition is applicable to both large and small storage and use capacity, no matter where located, because both types of facilities have the same possibility of discharge as described in §112. 1( b). The same rationale applies to stripper oil and gas well facilities, and to oil­ water separators. An owner or operator of a small facility above the regulatory threshold is subject to the rule, and needs to know how to calculate his storage or use capacity. Farms. We also disagree that we should exempt farm operations because such operations may be the source of a discharge as described in §112.1( b). We have, however, raised the regulatory threshold to a storage or use capacity greater than 1, 320 gallons, which will have the effect of exempting many small farm facilities from the scope of the rule. Floating fuel tanks. We also note that barges which store oil, are permanently moored or fastened to the shore, and are no longer used for transportation, are no longer vessels, but bulk storage containers that are part of an offshore facility. Likewise, a container, whether onshore or offshore, which was formerly used for transportation, such as a truck or railroad car, which now is used to store oil, is no longer used for a transportation purpose, and is a bulk storage container. Largest unit. We disagree that the risk posed by a facility is more accurately measured by the size of the largest individual unit at the facility rather than the facility's aggregate storage capacity. More than one unit may fail at once. For example, permanently manifolded containers are designed, installed, and/ or operated in such a manner that multiple containers function as one storage unit. In a worst case discharge scenario, a single failure could cause a discharge as described in §112.1( b) of the contents of more than one container. No threshold. We disagree that we should omit the capacity criterion for total storage capacity at a facility, and instead focus on tank size. More than one container may fail 49 at the same time due to human error or a catastrophic event whether the containers are interconnected or not. For example, permanently manifolded containers are designed, installed, and/ or operated in such a manner that multiple containers function as one storage unit. In a worst case discharge scenario, a single failure could cause a discharge as described in §112.1( b) of the contents of more than one container. Oil­ filled equipment. Types of containers counted as storage capacity would include flo­ through separators, tanks used for "emergency" storage, test tanks, transformers, and other oil­ filled equipment. This equipment may also experience a discharge as described in §112.1( b) and is therefore properly regulated under the SPCC program. Treatment tanks. We agree with the commenter that certain wastewater treatment facilities or parts thereof should be exempted from the rule, if used exclusively for wastewater treatment and not used to meet any other requirement of part 112. We have therefore amended the rule to reflect that agreement (see §112.1( d)( 6)). No longer subject to the rule would be wastewater treatment facilities or parts thereof such as treatment systems at POTWs and industrial facilities treating oily wastewater. Many of these wastewater treatment facilities or parts thereof are subject to NPDES or state­ equivalent permitting requirements that involve operating and maintaining the facility to prevent discharges. 40 CFR 122.41( e). The NPDES or state­ equivalent process ensures review and approval of the facility's: plans and specifications; operation/ maintenance manuals and procedures; and, Stormwater Pollution Prevention Plans, which may include Best Management Practice Plans (BMP). Many affected facilities are subject to a BMP prepared under an NPDES permit. Some of those plans provide protections equivalent to SPCC Plans. BMPs are additional conditions which may supplement effluent limitations in NPDES permits. Under section 402( a)( 1) of the CWA, BMPs may be imposed when the Administrator determines that such conditions are necessary to carry out the provisions of the Act. See 40 CFR 122.44( k). CWA section 304( e) authorizes EPA to promulgate BMPs as effluent limitations guidelines. NPDES rules provide for BMPs when: authorized under section 304( e) of the CWA for the control of toxic pollutants and hazardous substances; numeric limitations are infeasible; or, the practices are reasonably necessary to achieve effluent limitations and standards to carry out the purposes of the CWA. In addition, each NPDES or state equivalent permit for a wastewater treatment system must contain operation and maintenance requirements to reduce the risk of discharges. 40 CFR 122.41( e). Additionally, some wastewater is pretreated prior to discharge to a permitted wastewater treatment facility. The CWA authorizes EPA to establish pretreatment standards for pollutants that pass through or interfere with the operation of POTWs. The General Pretreatment Regulations (GPR), which set for the framework for the implementation of categorical pretreatment standards, are found at 40 CFR part 403. The GPR prohibit a user from introducing a pollutant into a POTW which causes pass through or interference. 40 CFR 403.5( a)( 1). More specifically, the GPR also prohibit 50 the introduction into of POTW of "petroleum, oil, nonbiodegradable cutting oil, or products of mineral oil origin in amounts that will cause interference or pass through. 40 CFR 403.5( b)( 6). EPA believes that the GPR and the more specific categorical pretreatment standards, some of which allow indirect dischargers to adopt a BMP as an alternative way to meet pretreatment standards, will work to prevent the discharge of oil from wastewater treatment systems into navigable waters or adjoining shorelines by way of a POTW. However, if a wastewater facility or part thereof is used for the purpose of storing oil, then there is no exemption, and its capacity must be counted as part of the storage capacity of the facility. Any oil storage capacity associated with or incidental to these wastewater treatment facilities or parts thereof continues to be subject to part 112. At permitted wastewater treatment facilities, storage capacity includes bulk storage containers, hydraulic equipment associated with the treatment process, containers used to store oil which feed an emergency generator associated with wastewater treatment, and slop tanks or other containers used to store oil resulting from treatment. Some flow through treatment such as oil/ water separators have a storage capacity within the treatment unit itself. This storage capacity is subject to the rule. An example of a wastewater treatment unit that functions as storage is a treatment unit that accumulates oil and performs no further treatment, such as a bulk storage container used to separate oil and water mixtures, in which oil is stored in the container after removal of the water in the separation/ treatment process. We do not consider wastewater treatment facilities or parts thereof at an oil production, oil recovery, or oil recycling facility to be wastewater treatment for purposes of this paragraph. These facilities generally lack NPDES or state­ equivalent permits and thus lack the protections that such permits provide. Production facilities are normally unmanned and therefore lack constant human oversight and inspection. Produced water generated by the production process normally contains saline water as a contaminant in the oil, which might aggravate environmental conditions in addition to the toxicity of the oil in the case of a discharge. Additionally, the goal of an oil production, oil recovery, or oil recycling facility is to maximize the production or recovery of oil, while eliminating impurities in the oil, including water, whereas the goal of a wastewater treatment facility is to purify water. Neither an oil production facility, nor an oil recovery or oil recycling facility treats water, instead they treat oil. For purposes of this exemption, produced water is not considered wastewater and treatment of produced water is not considered wastewater treatment. Therefore, a facility which stores, treats, or otherwise uses produced water remains subject to the rule. At oil drilling, oil production, oil recycling, or oil recovery facilities, treatment units subject to the rule include open oil pits or ponds associated with oil production operations, oil/ water separators (gun barrels), and heater/ treater units. Open oil pits or ponds function as another form of bulk storage container and are not used for wastewater treatment. Open oil pits or ponds also pose numerous environmental risks to birds and other wildlife. 51 Examples of wastewater treatment facilities or parts thereof used to meet a part 112 requirement include an oil/ water separator used to meet any SPCC requirement. Oil/ water separators used to meet SPCC requirements include oil/ water separators used as general facility secondary containment (i. e., §112.7( c), secondary containment requirements for loading and unloading (i. e., §112.7( h)), and for facility drainage (i. e., §112.8( b) or §112.9( b)). Whether a wastewater treatment facility or part thereof is used exclusively for wastewater treatment (i. e., not storage or other use of oil) or used to satisfy a requirement of part 112 will often be a facility specific determination based on the activity associated with the facility or part thereof. Only the portion of the facility (except at an oil production, oil recovery, or oil recycling facility) used exclusively for wastewater treatment and not used to meet any part 112 requirement is exempt from part 112. Storage or use of oil at such a facility will continue to be subject to part 112. Although we exempt wastewater treatment facilities or parts thereof from the rule under certain circumstances, a mixture of wastewater and oil still is "oil" under the statutory and regulatory definition of the term (33 USC 1321( a)( 1) and 40 CFR 110.2 and 112.2). Thus, while we are excluding from the scope of the rule certain wastewater treatment facilities or parts thereof, a discharge of wastewater containing oil to navigable waters or adjoining shorelines in a "harmful quantity" (40 CFR Part 110) is prohibited. Thus, to avoid such discharges, we would expect owners or operators to comply with the applicable permitting requirements, including best management practices and operation and maintenance provisions. USTs. We agree that completely buried tanks that are subject to all of the technical requirements of 40 CFR part 280 or a State program approved under 40 CFR part 281 should be exempted from part 112, and have taken that action. See section V. C of this document. Vaulted tanks. We also disagree that we should exempt aboveground, vaulted tanks from part 112. Vaulted tanks are generally excluded from the scope of 40 CFR part 280. The definition of "underground storage tank" at 40 CFR 280.12( i) excludes from its scope a "storage tank situated in an underground area (such as a basement, cellar, mineworking, drift, shaft, or tunnel) if the storage tank is situated upon or above the surface of the floor." These tanks might reasonably experience a discharge as described in §112.1( b). Therefore, it is reasonable that they be within the scope of part 112. Merely because these tanks are the subject of local fire and safety regulations does not guarantee that there will be adequate environmental protection to prevent a discharge as described in §112.1( b), because that is not the purpose of those regulations. Such codes may provide lesser protection than part 112. For example, NFPA 30: 2­ 3.4.3( b) specifically indicates that a dike need only provide containment for the largest tank, while part 112 requires freeboard for precipitation. Volume, not capacity. We also disagree that we should base the regulation on the amount of oil actually stored in the tanks. In most instances the shell capacity of a 52 container will define its storage capacity. The shell capacity (or nominal or gross capacity) is the amount of oil that a container is designed to hold. If a certain portion of a container is incapable of storing oil because of its integral design, for example electrical equipment or other interior component might take up space, then the shell capacity of the container is reduced to the volume the container might hold. When the integral design of a container has been altered by actions such as drilling a hole in the side of the container so that it cannot hold oil above that point, shell capacity remains the measure of storage capacity because such alteration can be altered again at will to restore the former storage capacity. When the alteration is an action such as the installation of a double bottom or new floor to the container, the integral design of the container has changed, and may result in a reduction in shell capacity. We disagree that operating volume should be the measurement, because the operating volume of a tank can be changed at will to below its shell capacity. The key to the definition of "storage capacity" is the availability of the container for drilling, producing, gathering, storing, processing, refining, transferring, distributing, using, or consuming oil; whether it is available for one of those uses or whether it is permanently closed. Containers available for one of the above described uses count towards storage capacity, those not used for these activities do not. IV­ E( 1)­ 2 Other comments Comments: Scope of rule. "EPA has misinterpreted its authority under section 311( j)( 1) and has exceeded its jurisdiction in both existing and proposed regulations. Section 311( j)( 1)( C) provides authority to require spill prevention and containment equipment rather than authority to regulate facilities." (32, 42) We should clarify whether proposed §112.1( b)( 2) and §112.1( b)( 3) expanded the "scope of covered facilities" beyond those described in §112. 1( b)( 1). We should insert "described in subparagraph (1)" after "facilities" in subparagraphs (2) and (3). (L24) Automotive businesses. We should exclude from part 112, automotive businesses with a total aboveground storage volume of new or used oil in quantities of 10,000 gallons or less, and aboveground tanks with a volume of 2, 500 gallons or less. However, we should still require owners or operators to provide adequate secondary containment for the tanks, report releases to the EPA Administrator, and cleanup releases within 72 hours. (71) Mobile containers. Inclusion. We should include mobile and portable container capacity within this calculation. (L11) Exclusion. We should exclude the capacity of mobile or portable containers of oil from a facility's total aboveground storage capacity determination. (33, 89) Production facilities, large or small. We should modify the proposed requirements to recognize that a small production facility presents little actual threat of a spill (based on 53 history and amount of oil present). (28) We could inadvertently cover some facilities not currently covered by the SPCC rule. The commenter explained that some production locations may have total storage capacity which exceeds the volume of fluid ever stored in the tanks. (86) We should exclude production tanks because aboveground tanks associated with producing oil and gas wells are small, remotely located and generally constructed to API Production Standards. (167) Interprets a statement in the preamble to mean that small and large facility classifications would not apply to oil production facilities. Asks whether this assumption is true. (L15) Reasonable expectation of discharge. Many SPCC­ regulated facilities are not located near a permanent surface water body, so an accidental discharge from them will rarely reach surface waters. (75, 79) We should obtain data and provide specific parameters to determine whether an accidental discharge could "reasonably be expected" to reach navigable waters. (75) Can industry. We should reconsider the scope of the program for the can­ making industry, already governed by many spill­ prevention and accidental release regulations. (62) Response: Scope of rule. Proposed §112.1( b)( 2) and (3) (§ 112.1( b)( 3) and (4) in the final rule) do not expand the applicability of the rule beyond facilities described in proposed §112.1( b)( 1). In response to the commenter's suggestion, we have revised §112.1( b) to list the types of containers that may be subject to the rule. We note, in response to comment, that we do not regulate all facilities in the United States. We only regulate facilities storing or using oil over the regulatory threshold amount from which there is a reasonable possibility of a discharge as described in §112. 1( b). CWA section 311( j)( 1)( C) authorizes EPA to establish procedures, methods, and equipment, and other requirements for equipment to prevent and contain discharges of oil from onshore facilities. This rule establishes such procedures, methods, and in some cases equipment or other requirements for equipment to prevent and contain discharges from facilities and, thus, is consistent with that authority. Automotive businesses. We disagree that we should exclude from part 112, automotive businesses with a total aboveground storage volume of new or used oil in quantities of 10,000 gallons or less, and aboveground tanks with a volume of 2, 500 gallons or less whether we required the owner or operator to provide adequate secondary containment for the tanks, report releases to the EPA Administrator, and cleanup releases within 72 hours or not. Such facilities could be the source of a discharge as described in §112.1( b) and must therefore be regulated. Mobile containers. We disagree that we should exclude the capacity of mobile or portable containers of oil from a facility's total aboveground storage capacity determination. A mobile facility could be the source of a discharge as described in §112.1( b) and must therefore be regulated. 54 Production facilities, large or small. We do not differentiate in the rule between large and small facilities because the possibility of a discharge as described in §112. 1( b) is the same for both. Therefore, any facility with the requisite storage or use capacity, whether a small or large production facility, is subject to part 112. We note that shell capacity is the measure of capacity. See the discussion concerning shell capacity in section IV­ E( 1)­ 1 of this document. Reasonable expectation of discharge. We disagree that we could or should set specific parameters to determine whether an accidental discharge could reasonably be expected to reach protected areas. Such a determination is dependent upon facilityspecific and location­ specific factors. Can industry. The can­ making industry may store or use oil. If a can industry facility may reasonably be expected to discharge oil as described in §112.1( b) and has the requisite storage or use capacity, it is subject to the rule. However, an owner or operator of an SPCC facility may use an alternative plan as a substitute for an SPCC Plan if such plan meets all applicable part 112 requirements and is cross­ referenced to such requirements. An owner or operator also may supplement an alternative plan that does not meet all part 112 provisions with sections that do meet part 112. IV ­ E( 2): Applicability ­ Electrical and other oil­ filled equipment Background: In the 1991 preamble, we noted that certain facilities may have equipment, such as electrical transformers, that contains significant quantities of oil necessary for operational purposes. We also clarified that an owner or operator must consider the oil storage capacity of oil­ filled equipment when determining total storage capacity for subjection to SPCC regulation. Equipment use for operational purposes is not subject to the bulk storage container provisions, such as §§ 112.8( c) and 112.9( d). However, such equipment is subject to other applicable SPCC requirements, including the general requirements in §112.7. Comments: Authority. No CWA authority. "To be consistent with legislative intent, the Agency should make clear that the SPCC requirements do not apply to electrical equipment and to other devices that use oil operationally." (3, 66, 92, 98, 100, 104, 125, 132, 134, 138, 156, 162, 163, 164, 170, 175, 184, 189, L2, L6, L7, L14, L16, L20) Rule activities ­ storage or use of oil. We should clarify whether oil­ filled equipment, such as transformers and oil breakers, are oil storage tanks. (66) Because "electrical equipment does not `consume' oil or oil products," and because none of the other activities listed are relevant to electrical equipment in the applicability section, the rule does not apply to it. Activities listed in the §112. 1( b)( 1) applicability criteria involve oil movement from one storage vessel to another, whereas dielectric fluid remains stationary and does not pose a risk to the environment. (125, 189) We should add a §112.1( d)( 5) to specifically 55 exclude from the SPCC rule, equipment or machinery containing oil for operational use rather than storage. (138) Asks us to confirm that facilities with oil­ filled electrical equipment are not engaged in the §112.1( b) activities and are not subject to SPCC requirements. (184) We should exclude oil­ filled equipment from the SPCC regulations. We should expand the examples of equipment (that contain significant quantities of oil for operational purposes rather than storage purposes) identified in the preamble to include transformers, capacitors, and other manufacturing equipment such as small lube oil systems, fat traps, and oil­ water separators. (L6) Facility definition. Substations and other installations containing electrical equipment are not facilities as defined in proposed §112.2( f). Electrical equipment does not fall under §112.1( b)( 1) since this section applies to facilities that consume oil, and the proposed §112.2( f) definition does not include units that consume oil. (125, 189) We should base our §112.1( b) applicability criteria on the proposed §112.2( f) facility definition so that the rule applies to oil well drilling operations, oil production, oil refining, oil storage, and waste treatment only. (189) UST rules. The Underground Storage Tank (UST) program (part 280) excludes equipment or machinery containing regulated substances (i. e., oil or dielectric fluid) for operational purposes, such as hydraulic lift tanks and electrical equipment tanks. (170, 189) Bulk storage. We should not consider electrical equipment as bulk storage containers and that proposed §§ 112.8( c) and 112.9( d) should not apply to such equipment. (41, 170, 164, 184) We should specifically state in the rule – not the preamble – that electrical equipment is not a bulk tank under the SPCC rule. (175) Products used in electrical equipment are distinct from oils stored in bulk storage tanks. (184) Whose storage capacity? Frequently, the power company – not the facility owner or operator – owns the transformer. In such a case, must the owner or operator must include the equipment's oil capacity in determining applicability? (39) Risk. "First, electrical equipment poses substantially less risk to the environment than do tanks, and second, many tank requirements are simply inappropriate for electrical equipment." (39, 41, 66, 125, 164, 170) Electrical equipment poses no sufficient environmental risk because of stringent design, construction, and inspection standards. (184, 189) Cable systems. "The Agency should exclude underground electric cable systems from SPCC requirements, regardless of the Agency's position on other types of electrical equipment.... ... The technology simply does not exist currently to apply the secondary containment, inspection, and integrity testing requirements of the SPCC program to underground cable systems." (125) We 56 should exclude electric cable systems from the rule, since such systems include tanks and reservoirs for back­ up oil and are surrounded by dielectric fluids. We should recognize that electric utility facilities include features that serve operational functions and reduce risks associated with potential discharges. If we do not exclude electric cable systems from SPCC requirements, then we should require owners or operators to prepare contingency plans, but should delete the proposed requirement to submit contingency plans when containment or diversion is not feasible. (175) We should exclude electrical equipment from the SPCC program or tailor the program to reflect specific electrical equipment characteristics. Due to the location, size, and nature of underground cable systems that extend many miles under urban streets, it is impossible for such systems to comply with SPCC tank requirements. SPCC requirements cannot be applied to dielectric fluid­ filled cable systems because the design, construction, and operation of such systems differ from tank systems. (125, 189) Response: Authority, use of oil. We disagree that operational equipment is not subject to the SPCC rule. We have amended §112.1( b) to clarify that using oil, for example operationally, may subject a facility to SPCC jurisdiction as long as the other applicability criteria apply, for example, oil storage capacity, or location. Such a facility might reasonably be expected to discharge oil as described in §112.1( b). Therefore, the prevention of discharges from such facility falls within the scope of the statute. However, we have distinguished the bulk storage of oil from the operational use of oil. We define "bulk storage container" in the final rule to mean any container used to store oil. The storage of oil may be prior to use, while being used, or prior to further distribution in commerce. For clarity, we have specifically excluded oil­ filled electrical, operating, or manufacturing equipment from the "bulk storage container" definition. Facilities that use oil operationally include electrical substations, facilities containing electrical transformers, and certain hydraulic or manufacturing equipment. The requirements for bulk storage containers may not always apply to these facilities since the primary purpose of this equipment is not the storage of oil in bulk. Facilities with equipment containing oil for ancillary purposes are not required to provide the secondary containment required for bulk storage facilities (§ 112. 8( c)) and onshore production facilities (§ 112. 9( c)), nor implement the other provisions of §112. 8( c) or §112. 9( c). Oil­ filled equipment must meet other SPCC requirements, for example, the general requirements of this part, including §112.7( c), to provide appropriate containment and/ or diversionary structures to prevent discharged oil from reaching a navigable watercourse. The general requirement for secondary containment, which can be provided by various means including drainage systems, spill diversion ponds, etc., will provide for safety and also the needs of section 311( j)( 1)( C) of the CWA. EPA will continue to evaluate whether the general secondary containment requirements found in §112.7( c) should be modified for small electrical and other types of equipment which use oil for operating purposes. We intend to publish a notice asking for additional data and comment on this issue. 57 In addition, a facility may deviate from any inappropriate SPCC requirements if the owner or operator explains his reasons for nonconformance and provides equivalent environmental protection by some other means. See §112.7( a)( 2). See also §112.7( d). Facility definition. We disagree that our authority does not extend to facilities. Section 311( j)( 1)( C) of the statute authorizes and requires the President (and EPA, through delegation in Executive Order 12777, 56 FR 54757, October 22, 1991) to issue regulations consistent with the National Oil and Hazardous Substances Pollution Contingency Plan, and consistent with maritime safety and with marine and navigation laws, which establish "procedures, methods, and equipment and other requirements for equipment to prevent discharges of oil and hazardous substances from vessels and from onshore and offshore facilities, and to contain such discharges." This language authorizes the President to issue oil spill prevention rules which pertain to onshore facilities and offshore facilities and not just "equipment." In order to fulfill the statutory mandate, it is necessary to regulate the facilities from which discharges emanate. Moreover, although the term "facility" is not defined in the statute, both "onshore facility" and "offshore facility" are defined terms in CWA section 311. They have also been defined terms in the SPCC rule since its inception in 1974. In the 1991 proposal, EPA proposed a definition of "facility" to implement the CWA. That definition was based on a Memorandum of Understanding (MOU) between the Secretary of Transportation and the EPA Administrator dated November 24, 1971 (36 FR 24080). The MOU, which has been published as Appendix A to part 112 since December 11, 1973 (38 FR 34164, 34170), defines in detail what constitutes a facility. Thus, there has long been a common understanding of the term. That understanding has been reinforced by frequent use of the term in context within the SPCC rule since it became effective in 1974. To promote clarity and to maintain all definitions in one place, the proposed definition has been finalized in this rulemaking. While section 311( j)( 1)( C) of the Act may not explicitly mention jurisdictional criteria, section 311( b) of the Act does. Section 311( b) establishes as the policy of the United States that there shall be "no discharges of oil or hazardous substances into or upon the navigable waters of the United States, adjoining shorelines, or into or upon the waters of the contiguous zone, or in connection with activities under the Outer Continental Shelf Lands Act or the Deepwater Port Act of 1974, or which may affect natural resources belonging to, appertaining to, or under the exclusive management authority of the United States (including resources under the Magnuson Fishery Conservation and Management Act)." Thus, the location or "jurisdictional" criteria contained in §112.1( b) are appropriate for inclusion in the rule. UST rules. The two programs (SPCC and UST) have different purposes. Therefore, the rules differ in important aspects. Operational equipment is 58 included under the SPCC rules because such equipment may experience a discharge as described in §112.1( b). Bulk storage. We agree and clarify in today's rule that oil­ filled electrical, operating, or manufacturing equipment is not a bulk storage container. See the discussion on the applicability of the rule to electrical and other operating equipment under §112.1( b) in today's preamble and this section. See also the definition of "bulk storage container" in §112.2. For a discussion of minimum size containers to which the rule applies, see the discussion under §112.1( d)( 2)( ii) in today's preamble and in section V. G of this document. Regulatory threshold, storage capacity. Oil stored in operating equipment counts as storage capacity for purposes of determining whether the facility meets the regulatory threshold of greater than 1,320 gallons for aboveground containers. Such equipment or machinery might reasonably be expected to discharge oil as described in §112.1( b). Aggregate capacity is important even if the equipment is not hydraulically interconnected because if a catastrophic event were to occur, all of the equipment might fail at once and discharge oil. The key to the definition of storage capacity is the availability of the container for drilling, producing, gathering, storing, processing, refining, transferring, distributing, using, or consuming oil; whether it is available for one of those uses or whether it is permanently closed. Containers available for one of the above described uses count towards storage capacity, those not used for these activities do not. Types of containers counted as storage capacity would include flothrough separators, tanks used for "emergency" storage, transformers, and other oilfilled equipment. In response to the comment that the power company – not the facility owner or operator – frequently owns the transformers located at the facility, we note that the SPCC regulations generally prescribe requirements for the owner or operator of a facility. Either or both may be responsible for part 112 compliance. Risk. We also disagree that electrical equipment poses no environmental risk because of stringent design, construction, and inspection standards. Such standards are not necessarily aimed at preventing discharges as described in §112. 1( b), and a facility containing such equipment might reasonably be expected to experience a discharge. Therefore, it may fall within the scope of the statute. Specific rules. We agree that differentiated rules may be warranted for facilities using electrical or other oil­ filled operating equipment. In 1995, Congress enacted the Edible Oil Regulatory Reform Act (EORRA), 33 U. S. C. 2720. That statute mandates that most Federal agencies differentiate between and establish separate classes for various types of oils, specifically: animal fats and oils and greases, and fish and marine mammal oils; oils of vegetable origin; petroleum oils, and other non­ petroleum oils and greases. In differentiating between these classes of oils, Federal agencies are directed to consider differences in the physical, chemical, biological, and other properties, and in the environmental effects, of the classes. In response to EORRA, as noted above, 59 we have divided the requirements of the rule by subparts for facilities storing or using the various classes of oils listed in that act. Because at the present time EPA has not proposed differentiated SPCC requirements for public notice and comment, the requirements for facilities storing or using all classes of oil will remain the same. However, we have published an advance notice of proposed rulemaking seeking comments on how we might differentiate among the requirements for the facilities storing or using various classes of oil. 64 FR 17227, April 8, 1999. If after considering these comments, there is adequate justification for differentiation among the requirements for those facilities, including facilities with electrical or other oil­ filled operating equipment, we will propose rule changes. Deviations are available when a requirement is not appropriate for a particular kind of facility. See categories X­ B and E of this document, and §112.7( a)( 2) and (d). IV­ E( 3): Minimum container size ­ §112.1( d)( 2) and (5) Background: Under §112.1( d)( 2) of the current rule, all size containers are counted in determining the storage capacity of the facility. In 1991, we proposed no changes in the size of a container which must be counted. Comments: Exclude small containers. "As written, this captures pints, quarts, equipment reservoirs of any size, once a facility determined that it was covered under this regulation." "Clearly, compliance with these requirements for all containers of any size will be extremely burdensome for some of the regulated community and will greatly upset ongoing manufacturing operations, while providing no significant increase in protection of human health and the environment." (33, 62, 66, 115, 119, 127, 175, 190, L7) Suggested thresholds for minimum size­ aboveground storage. 250 gallons or less. (62). 55 gallons or less. (29, 57, 103, 119, L24) 660 gallons or less. (22, 48, 67, 91, 92, 98, 106, 125, 133, 150, 167, 182, 187, L14) 10,000 gallons. (170) 25,000 gallons. (189) Response: Minimum container size. In response to comments, we are introducing a minimum container size to use for calculation of the capacity of aboveground storage tanks and completely buried containers. Therefore, you need only count containers of 55 gallons or greater in the calculation of the regulatory threshold for storage capacity. 60 You need not count containers, like pints, quarts, and small pails, which have a storage capacity of less than 55 gallons, in capacity calculations. Some SPCC facilities might therefore drop out of the regulated universe of facilities. You should note, however, that EPA retains authority to require any facility subject to its jurisdiction under section 311( j) of the CWA to prepare and implement an SPCC Plan, or applicable part, to carry out the purposes of the Act. While some commenters had suggested a higher threshold level, we believe that inclusion of containers of 55 gallons or greater within the calculation for the regulatory threshold is necessary to ensure environmental protection. If we finalized a higher minimum size, the result in some cases would be large amounts of aggregate capacity that would not be counted for SPCC purposes, and would therefore be unregulated, posing a threat to the environment. We believe that it is not necessary to apply SPCC or FRP rules requiring measures like secondary containment, inspections, or integrity testing, to containers smaller than 55 gallons storing oil because a discharge from these containers generally poses a smaller risk to the environment. Furthermore, compliance with the rules for these containers could be extremely burdensome for an owner or operator and could upset manufacturing operations, while providing little or no significant increase in protection of human health or the environment. Many of these smaller containers are constantly being emptied, replaced, and relocated so that serious corrosion will likely soon be detected and undetected leaks become highly unlikely. While we realize that small discharges may harm the environment, depending on where and when the discharge occurs, we believe that this measure will allow facilities to concentrate on the prevention and containment of discharges of oil from those sources most likely to present a more significant risk to human health and the environment. IV ­ G Wastewater Treatment ­ §112.1( d)( 6). Background: In 1991, EPA proposed various changes to §112.1( d) concerning exemptions to part 112, and received comments on its proposals. Among those comments was one suggesting an exemption for certain treatment systems. Comments: One commenter suggested that the "§ 112.1 exceptions should be expanded to include facility storage and treatment tanks associated with `non­ contact cooling water systems' and/ or `storm water retention and treatment systems. Although these tanks are designed to remove spilled oil from manufacturing operations and parking lot runoff, the concentration of oil in the water at any given time would be insignificant. These tanks are typically very large, i. e., in excess of 100,000 gallons, and are typically not contained by diked walls or impervious surfaces. GM believes the cost to contain these structures could be better spent on other SPCC regulatory requirements." Response: We agree with the commenter that certain wastewater treatment facilities or parts thereof should be exempted from the rule, if used exclusively for wastewater treatment and not used to meet any other requirement of part 112. We have therefore 61 amended the rule to reflect that agreement. No longer subject to the rule would be wastewater treatment facilities or parts thereof such as treatment systems at POTWs and industrial facilities treating oily wastewater. Many of these wastewater treatment facilities or parts thereof are subject to NPDES or state­ equivalent permitting requirements that involve operating and maintaining the facility to prevent discharges. 40 CFR 122.41( e). The NPDES or state­ equivalent process ensures review and approval of the facility's: plans and specifications; operation/ maintenance manuals and procedures; and, Stormwater Pollution Prevention Plans, which may include Best Management Practice Plans (BMP). Many affected facilities are subject to a BMP prepared under an NPDES permit. Some of those plans provide protections equivalent to SPCC Plans. BMPs are additional conditions which may supplement effluent limitations in NPDES permits. Under section 402( a)( 1) of the CWA, BMPs may be imposed when the Administrator determines that such conditions are necessary to carry out the provisions of the Act. See 40 CFR 122.44( k). CWA section 304( e) authorizes EPA to promulgate BMPs as effluent limitations guidelines. NPDES rules provide for BMPs when: authorized under section 304( e) of the CWA for the control of toxic pollutants and hazardous substances; numeric limitations are infeasible; or, the practices are reasonably necessary to achieve effluent limitations and standards to carry out the purposes of the CWA. In addition, each NPDES or state equivalent permit for a wastewater treatment system must contain operation and maintenance requirements to reduce the risk of discharges. 40 CFR 122.41( e). Additionally, some wastewater is pretreated prior to discharge to a permitted wastewater treatment facility. The CWA authorizes EPA to establish pretreatment standards for pollutants that pass through or interfere with the operation of POTWs. The General Pretreatment Regulations (GPR), which set for the framework for the implementation of categorical pretreatment standards, are found at 40 CFR part 403. The GPR prohibit a user from introducing a pollutant into a POTW which causes pass through or interference. 40 CFR 403.5( a)( 1). More specifically, the GPR also prohibit the introduction into of POTW of "petroleum, oil, nonbiodegradable cutting oil, or products of mineral oil origin in amounts that will cause interference or pass through. 40 CFR 403.5( b)( 6). EPA believes that the GPR and the more specific categorical pretreatment standards, some of which allow indirect dischargers to adopt a BMP as an alternative way to meet pretreatment standards, will work to prevent the discharge of oil from wastewater treatment systems into navigable waters or adjoining shorelines by way of a POTW. However, if a wastewater facility or part thereof is used for the purpose of storing oil, then there is no exemption, and its capacity must be counted as part of the storage capacity of the facility. Any oil storage capacity associated with or incidental to these wastewater treatment facilities or parts thereof continues to be subject to part 112. At permitted wastewater treatment facilities, storage capacity includes bulk storage containers, hydraulic equipment associated with the treatment process, containers used to store oil which feed an emergency generator associated with wastewater 62 treatment, and slop tanks or other containers used to store oil resulting from treatment. Some flow through treatment such as oil/ water separators have a storage capacity within the treatment unit itself. This storage capacity is subject to the rule. An example of a wastewater treatment unit that functions as storage is a treatment unit that accumulates oil and performs no further treatment, such as a bulk storage container used to separate oil and water mixtures, in which oil is stored in the container after removal of the water in the separation/ treatment process. We do not consider wastewater treatment facilities or parts thereof at an oil production, oil recovery, or oil recycling facility to be wastewater treatment for purposes of this paragraph. These facilities generally lack NPDES or state­ equivalent permits and thus lack the protections that such permits provide. Production facilities are normally unmanned and therefore lack constant human oversight and inspection. Produced water generated by the production process normally contains saline water as a contaminant in the oil, which might aggravate environmental conditions in addition to the toxicity of the oil in the case of a discharge. Additionally, the goal of an oil production, oil recovery, or oil recycling facility is to maximize the production or recovery of oil, while eliminating impurities in the oil, including water, whereas the goal of a wastewater treatment facility is to purify water. Neither an oil production facility, nor an oil recovery or oil recycling facility treats water, instead they treat oil. For purposes of this exemption, produced water is not considered wastewater and treatment of produced water is not considered wastewater treatment. Therefore, a facility which stores, treats, or otherwise uses produced water remains subject to the rule. At oil drilling, oil production, oil recycling, or oil recovery facilities, treatment units subject to the rule include open oil pits or ponds associated with oil production operations, oil/ water separators (gun barrels), and heater/ treater units. Open oil pits or ponds function as another form of bulk storage container and are not used for wastewater treatment. Open oil pits or ponds also pose numerous environmental risks to birds and other wildlife. Examples of wastewater treatment facilities or parts thereof used to meet a part 112 requirement include an oil/ water separator used to meet any SPCC requirement. Oil/ water separators used to meet SPCC requirements include oil/ water separators used as general facility secondary containment (i. e., §112.7( c), secondary containment requirements for loading and unloading (i. e., §112.7( h)), and for facility drainage (i. e., §112.8( b) or §112.9( b)). Whether a wastewater treatment facility or part thereof is used exclusively for wastewater treatment (i. e., not storage or other use of oil) or used to satisfy a requirement of part 112 will often be a facility specific determination based on the activity associated with the facility or part thereof. Only the portion of the facility (except at an oil production, oil recovery, or oil recycling facility) used exclusively for wastewater treatment and not used to meet any part 112 requirement is exempt from part 112. Storage or use of oil at such a facility will continue to be subject to part 112. 63 Although we exempt wastewater treatment facilities or parts thereof from the rule under certain circumstances, a mixture of wastewater and oil still is "oil" under the statutory and regulatory definition of the term (33 USC 1321( a)( 1) and 40 CFR 110.2 and 112.2). Thus, while we are excluding from the scope of the rule certain wastewater treatment facilities or parts thereof, a discharge of wastewater containing oil to navigable waters or adjoining shorelines in a "harmful quantity" (40 CFR Part 110) is prohibited. Thus, to avoid such discharges, we would expect owners or operators to comply with the applicable permitting requirements, including best management practices and operation and maintenance provisions. 64 Category V: Definitions ­ §112.2 Background: In §112.2 of the current rule are found definitions for terms used in 40 CFR part 112. In §112.2 of the 1991, we proposed revisions of certain definitions, adding some new definitions, and removing others. We also proposed to move the definitions of oil production facilities (onshore) and oil drilling, production, or workover facilities (offshore) from §112.7( e)( 5)( i) and 112.7( e)( 7)( i), respectively, to §112.2. V­ 1 Breakout tank Background: In §112.2( a) of the 1991 proposal, we proposed to define breakout tank to distinguish between facilities regulated by the U. S. Department of Transportation (DOT) and EPA. (Breakout tanks fall under DOT jurisdiction; we regulate facilities with bulk storage tanks.) Breakout tanks are used either to compensate for pressure surges or control and maintain pressure through pipelines. In §112.2 of the final rule, we adopted a modified version of DOT's 49 CFR part 195 definition, and defined a breakout tank as "a container used to relieve surges in an oil pipeline system or to receive and store oil transported by a pipeline for reinjection and continued transportation by pipeline." Comments: Support for a definition. Support for including a definition of breakout tank in part 112. (94, 95, 102) DOT definition. "Valvoline supports the inclusion of a definition of `breakout tank' in the proposed regulations. However, in light of the fact that this is a transportation­ related term, the definition should be identical to that contained in 40 CFR §195.2. An arbitrary change to this definition will result in wide spread confusion regarding what constitutes a breakout tank and which definition takes precedence. " (77, 95, 101, 102,113, 121, 153, 173, 175) We should consider providing guidance on when each agency regulates certain tanks. (94) Two different definitions would result in duplicative regulation of certain tanks. (102, 153) Response: On the suggestion of commenters, EPA has adopted a modified version of the DOT definition in 49 CFR 195.2. This revision promotes consistency in the DOT and EPA definitions to aid the regulators and regulated community. We modified the DOT definition by substituting the word "oil" for "hazardous liquid," because our rules apply only to oil. We also use in the definition the term "container" rather than just "tank" to cover any type of container. This terminology is consistent with other terminology used in this rule. A breakout tank that is used only to relieve surges in an oil pipeline system or to receive and store oil transported by a pipeline for reinjection and continued transportation by pipeline is subject only to DOT jurisdiction. When that same breakout tank is used for other purposes, such as a process tank or as a bulk storage container, it is no longer solely within the definition of breakout tank, and may be subject to EPA or other jurisdiction with the new use. See also the discussion of §112.1( d)( 1)( ii) in the 65 preamble to today's rule. EPA and DOT also signed a joint memorandum dated February 4, 2000, clarifying regulatory jurisdiction on breakout tanks. That memorandum is available to the public upon request. It is also available on our website at http:// www. epa. gov/ oilspill under the "What's New" section. V­ 2 Bulk storage container Background: In 1991, we proposed defining the term bulk storage tank to clarify the distinction between facilities regulated by DOT and EPA. The proposed definition was originally for "bulk storage tank." Comments: We should exclude electrical equipment from the bulk storage tank definition because such equipment does not consume or store oil. (41, 125, 134, 164) Response: We agree that electrical equipment is not bulk storage, and have revised the definition of bulk storage container to specifically exclude oil­ filled electrical, operating, or manufacturing equipment. While such equipment is not bulk storage, it is subject to the general requirements of the rule in §112.7. V ­3Bunkered tank Background: We proposed this definition in 1991 to clarify that bunkered tanks are a subset of partially buried tanks, and as such, subject to part 112 as aboveground tanks. Comments: The definition is "undecipherable and should be rewritten." The definition should be, "Bunkered tank means a partially buried tank, the portion of which lies above grade is covered with earth, sand, gravel, asphalt, or other material." (121) Response: EPA agrees that the commenter's proposed definition is clearer, and we have used it with a slight editorial change. Editorial change. We added a sentence to the definition noting that bunkered tanks are a subset of aboveground storage containers for purposes of this part. V­ 4 Completely buried tank Background: We proposed in §112.2( v) to define an underground storage tank (UST) as any tank completely covered with earth. We noted that tanks in subterranean vaults, bunkered tanks, or partially buried tanks are aboveground storage containers under part 112. We have editorially changed "underground storage tank" to "completely buried tank" to distinguish those tanks from the "underground storage tank" definition in part 280, which is broader than our definition. Comments: Consistency with part 280 definition. The part 112 definition of an UST should be consistent with the part 280 definition. (57, 78, 90, 109, 111, 116, 167, 180, 66 182, 187). The differences in the definitions in parts 112 and 280 would confuse the regulated community. (57, 90, 111) We should define an UST as any tank that is completely below grade, and completely covered with earth, including vaults, bunkered tanks, or partially buried tanks. (102, 121) The part 280 UST definition is more consistent with our statutory authority under the Clean Water Act (CWA) than the part 112 definition. (182) Our proposed definition is too narrow, because it includes only completely buried tanks. (67, 72, 102, 106, 133, 175, 182) New term needed. "Alyeska appreciates that EPA requires a different definition for underground tanks than 40 CFR Part 280. However, it is very confusing for the regulated community to have two different definitions to the term `underground storage tank. ' EPA should identify tanks that it wishes to exclude from SPCC Plan regulations by some other term to avoid this confusion. EPA invites inadvertent non­ compliance when it uses a term which has two different definitions." (27, 77, 87) Bunkered tanks, partially buried tanks. We should consider bunkered tanks and partially buried tanks as aboveground storage tanks under part 112. We should regulate a tank under part 112 as an aboveground tank only if it is not regulated under part 280. (190) Vaulted tanks. "In some locations (e. g., New York City), subterranean vaults are the method of secondary containment specified for underground storage tanks. The vault and tank in such cases are usually completely covered by earth and, thus, pose no threat to the waters of the US. Such tanks should be exempted from the SPCC requirements." (33, 67, 72, 121, 133, 175) Response: Support for proposal. We appreciate commenter support. Consistency with part 280 definition. We disagree that the scope of the part 112 exclusion for underground tanks should be consistent with the scope of the definition of "underground storage tank" in part 280. The programs are designed for different purposes, therefore, the definitions used will necessarily differ. To eliminate confusion with the part 280 definition, we have changed the proposed part 112 definition of "underground storage tank" to "completely buried tank" in this final rule. Part 280 includes within its UST definition tanks which have a volume up to ninety percent above the surface of the ground, which are considered aboveground tanks for part 112 purposes. Part 280 also regulates underground storage tanks containing hazardous substances, while the SPCC program regulates only facilities storing or using oil as defined in CWA section 311. The SPCC program also regulates other types of containers and facilities which part 280 excludes, such as: tanks used for storing heating oil for consumptive use on the premises where stored; certain pipeline complexes where oil is stored; and, oil­ water separators. 67 Other completely buried tanks excluded from the part 280 UST definition. Tanks in underground rooms or above the floor surface, or in other underground areas such as basements, cellars, mine workings, drifts, shafts, or tunnels are also not considered USTs for purposes of the part 280 definition. The purpose of the part 112 definition is to clarify that these are tanks that are technically underground but that, in a practical sense, are no different from aboveground tanks. They are situated so that, to the same extent as tanks aboveground, physical inspection for leaks is possible. Also, some of these tanks are designed such that in case of a discharge, oil would escape to the environment, a result which our program seeks to prevent. Editorial changes and clarifications. The words "completely below grade and...." were added to the first sentence of the definition. The purpose of that revision was to distinguish completely buried tanks from partially buried and bunkered tanks, which break the grade of the land, but are not completely below grade. We further clarify that such tanks may be covered not only with earth, but with sand, gravel, asphalt, or other material. The clarification brings the definition into accord with the coverings noted in the definition of "bunkered tank." In the second sentence, the word "subterranean" was deleted from "subterranean vaults" because all vaulted tanks, whether subterranean or aboveground, are counted as aboveground tanks for purposes of this rule. Bunkered tanks, partially buried tanks. We disagree that vaulted tanks, partially buried tanks, and bunkered tanks should be considered completely buried tanks, and therefore excluded from SPCC provisions. Such tanks may suffer damage caused by differential corrosion of buried and non­ buried surfaces greater than completely buried tanks, which could cause a discharge as described in §112.1( b). Vaulted tanks. Aboveground vaulted tanks are clearly ASTs. Subterranean vaulted tanks are also ASTs because they are not completely buried. While subterranean vaulted tanks may be completely below grade, they are not completely covered with earth, sand, gravel, asphalt, or other material. Therefore, because of their design, they pose a threat of discharge into the environment, and are excluded from our definition of completely buried tank. Subterranean vaulted tanks are also excluded from the part 280 UST definition of underground tank if the storage tank is situated upon or above the surface of the floor in an underground area providing enough space for physical inspection of the exterior of the tank. Therefore, if subterranean tanks were excluded from our definition of completely buried tank, they would likely not be regulated at all, and thereby be likely to pose a greater threat to the environment. V­ 5 Discharge Background: In proposed §112.2( e), we suggested modification of the definition of discharge to reflect changes in the1978 amendments to the CWA. 68 Comments: Section 402 discharges. We should exclude discharges regulated under CWA section 402 to eliminate duplicative regulations. (67, 125) Imminent danger. "Recommend that the definition of discharge include that there is at least an eminent danger that the spilled material reach a `navigable waterway'. Otherwise, it is too broad and would cover even spills within secondary containment." (28, 31, 101, 113, 121, 165, L15) Discharges within secondary containment or the facility. We should define discharge to include a spill, leak, or other release that reaches navigable waters. A spill or leak will not necessarily result in a discharge to navigable waters. (39, 121, L12) The proposed definition seems vague, because it is "unlikely to operationally prevent all spilling or leaking." It is unclear, for example, whether a drop of oil that falls "onto the outside casing of a tank during refilling would be considered a discharge, even if the oil did not reach the ground." The definition is inconsistent with part 112. (115) Our proposed definition appears to "regulate more than the quality of navigable waters." (L12) Response: Section 402 discharges. We agree that we should not regulate discharges under section 402 of the Act, and in the final rule, we have adopted the proposed definition of a discharge, which accomplishes that aim. Foreseeable or chronic point source discharges that are permitted under section 402 of the CWA, and that are either due to causes associated with the manufacturing or other commercial activities in which the discharger is engaged or due to the operation of the treatment facilities required by the NPDES permit, are to be regulated under the NPDES program. Other oil discharges in reportable quantities are subject to the requirements of section 311 of the CWA. Such spills or discharges are governed by section 311 even where the discharger holds a valid and effective NPDES permit under CWA section 402. Therefore, a discharge of oil to a publicly­ owned treatment work (POTW) would not be a discharge under the §112.2 definition if the discharge is in compliance with the provisions of the permit; or resulted from a circumstance identified and reviewed and made a part of the public record with respect to a permit issued or modified under section 402; or if it were a continuous or anticipated intermittent discharge from a point source, identified in a permit or permit application under section 402, which is caused by events occurring within the scope of relevant operating or treatment systems. 33 U. S. C. 1321( a)( 2); 40 CFR 117.12. Otherwise, the discharge is subject to the provisions of section 311 of the CWA as well as the unpermitted discharge prohibition of section 301( a) of the CWA. 33 U. S. C. 1311( a). Imminent danger. A discharge as described in §112.1( b) need not reach the level of an imminent danger to affected lands, waters, or resources to be a discharge. Discharges within secondary containment or the facility. We agree that we should define discharge to include a spill, leak, or other release that reaches navigable waters, and have done so. We define a discharge to include any spilling, leaking, pumping, emitting, emptying, or dumping of oil," with certain exclusions pertinent to section 402 69 of the CWA. We also agree that a spill, leak, or other type of discharge will not necessarily result in a discharge to navigable waters. A discharge includes any spilling, leaking, pumping, pouring, emitting, emptying, or dumping of any amount of oil no matter where it occurs. It may not be a reportable discharge under 40 CFR part 110 if oil never escapes the secondary containment at the facility and is promptly cleaned up. If the discharge escapes secondary containment, it may become a discharge as described in §112.1( b), and if that happens, the discharge must then be reported to the National Response Center. V­ 6 Facility Background: In §112.2( f) of the 1991 proposal, we proposed to define the term facility based on the definition in the 1971 MOU between EPA and DOT. (See 40 CFR part 112, Appendix A.) We proposed to define a facility as "any mobile or fixed, onshore or offshore building, structure, installation, equipment, pipe, or pipeline used in oil well drilling operations, oil production, oil refining, oil storage, and waste treatment." We noted that the extent of a facility may depend on several site­ specific factors, including, but not limited to, the ownership or operation of buildings, structures, equipment, and pipelines on the same site and the types of activities at the site. Comments: Facility boundaries. "The definition of facility are [sic] too broad. Not all buildings on an oil production lease are in contact with oil, nor are all pipeline structures, installations, or equipment. Their operation may in no way affect the possibility of an oil spill, and they should not have to be addressed in a SPCC plan as inclusion in this definition would require. The same is true for waste treatment activities. " (31, 101, 113, 160, 165, 188, L15) "The definition of facility is ambiguous. Is a facility the petroleum storage site, or ... a single tank at a site?" (111, 188) Pipes and piping. "Rather, the definition contemplates a fixed structure, or unit, which serves a purpose at the place where it is fixed. ... We suggest that EPA clarify the factors which will, rather than may, define the boundaries of a facility, specifically with regard to piping or pipelines which may extend past the physical boundaries of the facility." (188) Buried pipelines, gathering lines, flowlines, military housing units, waste treatment equipment. "Also, by including oil gathering lines in the facility definition, the size and extent of oil production facilities is multiplied at least a thousand­ fold. No secondary containment is possible for these lines...." (31) "Based on the proposed definition, it is unclear whether the regulation requires that all oil distribution and movement facilities be identified, such as buried pipelines, for volume storage estimates. This too presents a task which cannot readily be satisfied at many mining operations." (35, 28, 31, 58, 71, 101, 113, 165, L15). Military housing. We should amend the proposed definition to ensure that part 112 does not cover military housing units. Each such unit may store fuel oil in a 250­ gallon tank. (L29) 70 Waste treatment. We should not include the term waste treatment in the part 112 definition of a facility, unless the waste treated is from oil drilling or production operations. (L24, 31) Electrical or operational equipment. "Clearly, electrical equipment is not used in well drilling operations, oil production, oil refining, oil storage, or waste treatment. As such, oil­ filled electrical equipment is not a `facility' under the proposed SPCC regulations and not subject to the requirements established therein." (189) Mobile or fixed facilities. "CCIRT is concerned that the proposed definition is overly broad, because it encompasses mobile as well as fixed, structures and equipment. CCIRT considers this expansion of the definition to be inappropriate. ... Conceivably, a SPCC Plan for a mobile `facility' would have to be amended each time the mobile equipment is moved. This is likely to be an unworkable requirement. For these reasons, mobile equipment should not be considered a facility for purposes of SPCC regulations." (188) Response: We disagree that the definition is too broad. It includes the necessary elements of what may be a "facility." If one of those elements is not related to oil well drilling operations, oil production, oil refining, oil, storage, and waste treatment, or in which oil is used at the site, it is not part of the facility. Facility boundaries. A facility includes any building, structure, installation, equipment, pipe, or pipeline in oil well drilling operations, oil production, oil refining, oil storage, and waste treatment, or in which oil is used at a site, whether it is mobile or fixed. It may also include power rights of way connected to the facility. We also clarify that a vessel or a public vessel is not a facility or part of a facility. The extent of the facility will vary according to the circumstances of the site. It may be as small as a single container, or as large as all of the structures and buildings on a site. Some specific factors to use in determining the extent of a facility may be the ownership or operation of those buildings, structures, equipment, installations, pipes or pipelines, or the types of activities being carried on at the facility. Electrical or operational equipment. We disagree with commenters who maintained that electrical equipment "using" oil, as opposed to "storing" it, should not fall within the definition of "facility" in part 112. Section 311( j)( 1)( C) of the CWA, which authorizes EPA to promulgate the SPCC rule, does not distinguish between the storage and the usage of oil. The section simply authorizes EPA, as delegated by the President, to establish "requirements to prevent discharges of oil ... from onshore and offshore facilities, and to contain such discharges...." 33 U. S. C. 1321( j)( 1)( C). Nor do the definitions of "onshore facility" or "offshore facility" in sections 311( a)( 10) of the CWA distinguish between the use or storage of oil. Although the definition of "facility" in section 1001( 9) of the OPA is limited by the "purpose" of the facility, no such limitation appears in CWA section 311. Moreover, EPA believes that although much of the electrical equipment may arguably "use" oil, in effect the oil is "stored" in the equipment because it remains in the equipment for such long time frames. We added language to the definition to clarify that such types of equipment are facilities subject to the SPCC 71 rule whether they are storing or using oil. Therefore, we revised the definition to include the words "or in which oil is used." However, we note that a facility which contains only electrical equipment is not a bulk storage facility. Buried pipelines, gathering lines, flowlines, military housing units, waste treatment equipment. Buried pipelines that carry oil at mining sites are part of a facility unless they are permanently closed as defined in §112.2. Such pipelines may otherwise be the source of a discharge as described in §112.1( b). Likewise, the same rationale applies to gathering lines and flowlines, military housing units, and waste treatment equipment. Note that any facility or part thereof used exclusively for wastewater treatment and not to satisfy any part 112 requirement is exempted from the rule. The production, recovery, or recycling of oil is not considered wastewater treatment for purposes of the rule. See §112.1( d)( 6). While such gathering lines, flowlines, and waste treatment equipment are subject to secondary containment requirements, the appropriate method of secondary containment is an engineering question. Double­ walled piping may be an option, but is not required by these rules. The owner or operator and Professional Engineer certifying the Plan should consider whether pursuant to good engineering practice, double­ walled piping is the appropriate method of secondary containment according to good engineering practice. In determining whether to install double­ walled piping versus an alternative method of secondary containment, you could consider such factors as the additional effectiveness of double­ walled piping in preventing discharges, the technical aspects of cathodically protecting any buried double­ walled piping system, the cost of installing double­ walled pipe, and the potential fire and safety hazards of double­ walled pipes. Earthen or natural structures may be acceptable if they contain and prevent discharges as described in §112.1( b), including containment that prevents discharge of oil through groundwater that might cause a discharge as described in §112.1( b). What is practical for one facility, however, might not work for another. We also disagree with the argument that because the installation of structures and equipment to prevent discharges around gathering lines and flowlines may not be practicable, EPA will be flooded with contingency plans. First of all, secondary containment may be practicable. In §112.7( c), we list sorbent materials, drainage systems, and other equipment as possible forms of secondary containment systems. We realize that in many cases, secondary containment may not be practicable. If secondary containment is not practicable, you must provide a contingency plan in your SPCC Plan following the provisions of part 109, and otherwise comply with §112.7( d). We have deleted the proposed 1993 provision that would have required you to provide contingency plans as a matter of course to the Regional Administrator. Therefore, you will rarely have to submit a contingency plan to EPA. The contingency plan you do provide in your SPCC Plan when secondary containment is not practicable for flowlines and gathering lines should rely on strong maintenance, corrosion protection, testing, recordkeeping and inspection procedures to prevent and quickly detect discharges from such lines. It should also provide for the quick availability of response equipment. 72 Mobile or fixed facilities. Either mobile or fixed equipment might be the source of a discharge as described in §112.1( b), and therefore both are included within the definition of "facility." Section 112. 3( c) of this rule already provides that it is not necessary to amend your Plan each time a mobile facility moves to a new site. V ­7 Navigable waters Background: In §112.2( g) of the 1991 proposal, we proposed to revise the definition of navigable waters to conform to the definition in 40 CFR part 110. Comments: Definition too broad, clarification needed. (31, 35, 64, 73, 89, 101, 106, 113, 165, 174, 186, L15, L23) "We have two concerns with this proposal. First, we do not believe EPA should expand its jurisdictional authority since the jurisdiction provided under traditional notions of navigability and contained in the existing regulations is sufficient to protect the Nation's waters from bulk oil contamination. ... Second, under §404 of the Clean Water Act, EPA interprets the predicate jurisdictional trigger, `waters of the United States, ' in an expansive manner to include artificial and isolated wetlands." Wetland delineation is quite complex, and often includes areas that are not adjacent to navigable waters, nor even tributary or in any connected to navigable waters." (35) "We feel that compliance with these regulations could be more easily obtained if this definition was simplified." (94, 111, 166) "Using this interpretation, nearly all facilities would be located less than 500 feet from navigable waters. Some guidance as to the correct interpretation of this issue would be helpful." (107, 79, 167, 186, L17) Navigability. "The definition of navigable waters should be revised to match what Congress originally intended ­ waters that a boat of some kind (even a canoe) can travel on at all times of the year." (31, 73, 101, 106, 113, 165, L15) "Navigable Waters is defined in extremely broad terms under the proposed definition. While broad statutory references are made elsewhere in the proposed rule, no specific authority, legislative or judicial, is cited or identified to support this expansive definition." (64) Risk. "The EPA's emphasis in this phase of the SPCC revisions should be on controlling discharges from facilities with the greatest potential to discharge harmful quantities of oil to navigable waters. The broad applicability of the proposed SPCC revisions will overwhelm the regulated community." (167) "The proposed rule's mention of discharges into or upon the navigable waters of the United States together with the extremely broad interpretation of `navigable waters' and waters which flow to `navigable waters' could result in application of this rule to inland agricultural operations." (L23) Tributaries. Asks, "...( A) re ditches which flow miles to navigable waters considered tributaries?" (62) "Since the EPA considers tributaries to navigable water (i. e., rivers) as part of this definition, ultimately any size stream, including those which may be only intermittent, would be subject to this rule." (89) We 73 should define navigable waters as "unobstructed streams that free flow at least fourteen consecutive days per year." (186) Criteria. The definition should "include specific criteria such as flow volume." (89, 156) Maps. "Due to the broad definition of navigable waters, how is an operator to determine what is navigable water? Because this is such a confusing issue, an operator is at a loss to determine which facilities could reasonably be expected to discharge oil upon a navigable water. Will the EPA provide maps to aid in this determination?" (28, 69, 79, 101) Groundwater. "...( C) ongress intended for EPA to develop SPCC requirements that prevent releases to groundwater, in addition to requirements that prevent releases to navigable waters. Thus, SPCC regulations should be rewritten to prevent discharges to groundwater in addition to discharges to navigable waters. ... At a minimum, proposed section 112.1( d)( 1)( i) should contain language stating that clear hydrologic connections between groundwater underlying a facility and navigable waters require a facility to develop and implement an SPCC Plan." (44) Response: Clarification of the meaning of navigable waters, maps. In this definition, we clarify what we mean by navigable waters by describing the characteristics of navigable waters and by listing examples of navigable waters. We also note in the definition that certain waste treatment systems are not navigable waters. Navigability, legal authority. Navigable waters are not only waters on which a craft may be sailed. Navigable waters include all waters with a past, present, or possible future use in interstate or foreign commerce, including all waters subject to the ebb and flow of the tide. Navigable waters also include intrastate waters which could affect interstate or foreign commerce. The case law supports a broad definition of navigable waters, such as the one published today, and that definition does not necessarily depend on navigability in fact. Tributaries. For the reasons stated above, tributaries or intermittent streams are included in the definition of navigable waters, and it would therefore be inappropriate to limit the definition to unobstructed streams that free flow at least fourteen consecutive days a year. Maps. We are unable to provide a map to identify all navigable waters because not all such waters have been identified on a map. However, the rule provides guidelines as to where such waters may be found. Groundwater. EPA agrees with the commenter that groundwater underlying a facility that is directly connected hydrologically to navigable waters or adjoining shorelines could trigger the requirement to produce an SPCC Plan based on geographic or locational aspects of the facility. 74 V ­8 Offshore facility Background: In 1991, we proposed to revise the definition of offshore facility to conform with the CWA definition in section 311( a)( 11) and the National Oil and Hazardous Substances Pollution Contingency Plan (NCP) definition in 40 CFR 300.5. Comments: CWA definition. "Offshore Facility is defined in an ambiguous and circuitous manner in the proposed rules. Midway through the proposed definition, the unnecessarily redundant phrase `and any facility of any kind that is subject to the jurisdiction of the United States and is located in, on, or under any other waters' is included. The definition in the CWA is better and clearer." (64) EPA or DOI jurisdiction. "We note that if the definition of `offshore facility' in section 1001( 22) of OPA 90 is taken in context with the definition of `navigable waters' proposed for 40 CFR 112. 2( g), the jurisdiction for many facilities (including large numbers which have traditionally been subject to EPA jurisdiction) would be transferred to the Department of Interior (DOI) by E. O. 12777." (128) Response: CWA definition. EPA agrees with the commenter urging that the EPA definition track the statutory definition. The part 112 definition, except for minor editorial changes, is identical to the CWA definition. There is no difference between the substance of the part 112 definition and the CWA definition. EPA or DOI jurisdiction. The 1994 Memorandum of Understanding between DOI, DOT, and EPA addresses the jurisdictional issue to which the commenter refers, transferring to EPA those non­ transportation­ related offshore facilities landward of the coast line. V ­9 Oil Background: In current §112.2 we define oil as "oil of any kind or in any form, including, but not limited to, petroleum, fuel oil, sludge, oil refuse, and oil mixed with wastes other than dredged spoil." We proposed no changes in the definition in 1991. However, in the 1991 preamble, we explained this definition includes crude oil and refined petroleum products, as well as non­ petroleum oils (e. g., animal and vegetable oils). We solicited comments on the appropriateness of this approach. Comments: Support for proposal. (82, 121, 168, L8) "Section 311 of the CWA is unusual, in that it is the only section of the Act that has its own definition section. These definitions include one for oil. It is the same definition as the one presently appearing in part 112. There is nothing in section 311( j)( 1)( C) that indicates that Congress contemplated a departure from this oil definition for prevention regulations. EPA must stick with the present definition of oil. As a matter of fact, a vegetable oil spill resulted in a significant duck kill on the upper Mississippi in the 1960's." (121) Opposition to proposal. Our expanded interpretation of what constitutes oil will subject many more facilities to the SPCC Plan preparation requirements, or compel many facility 75 owners or operators to revise existing Plans. It is too broad. (89, 155, 184, 189) We should present our definition for public comment. (190) Petroleum products only. "The inclusion of refined petroleum in this interpretation includes a broad category of materials that do not necessarily fall within the original intent of Congress.... Releases from the storage of many of these chemicals and materials are currently regulated by other EPA programs, such as those found in CERCLA Section 304 and SARA Title III." (89) "No mention is made in the Clean Water Act, 40 CFR Part 110, or the Deep Water Port Act to vegetable oil." EPA should "( L) imit the definition of oil to petroleumbased crude oil and derivative products as intended by the Clean Water Act." (110) Other Federal and State rules. "PG& E believes that this definition sweeps too broadly and is inconsistent with parallel federal and state regulations which regulate the use, containment, and discharge of oil and petroleum products. .. PG& E encourages EPA to adopt the UST definition of petroleum as it applies to the preparation of SPCC plans." (78, 111, 125, 184) Specific substances. We should include in our definition of oil, examples of the materials covered under part 112. (62, 103, 156) Asks that we explicitly state the types of products regulated under part 112 so that State and local regulatory agencies do not make arbitrary and capricious interpretations. (189) "Clarification of the definition of `oil' is recommended. ... Considerable confusion on the definition of oil still exists." (190, L7) Asphalt cement. We should clarify whether our definition includes asphalt cement and other oil­ containing products that are not liquid at ambient temperature. (76) Viscosity. "There is no provision or consideration of the potential of the stored material to spill off­ site. For example, `petroleum' includes lubricating materials and asphalt cement which are highly viscous and could not flow very far if a tank or valve is damaged or vandalized. The potential for harm to any person, property or the environment is extremely limited." (125, 149) Chemicals and solvents. We should change the definition to include "chemicals and solvents that are stored in bulk in tanks in a manner similar to oils and (that) may cause comparable water pollution problems if discharged in harmful quantities as defined under 40 CFR Part 110." (9) Aromatic hydrocarbons. Asks whether "aromatic hydrocarbons and/ or subsequent derivatives" are considered oil. "Dow does not believe that it is EPA's intent to regulate such materials under 40 CFR Part 112." (L7). 76 Gasoline and diesel fuel. "The definition of oil should exclude gasoline and diesel fuel. The high volatility of diesel fuel and gasoline results in rapid evaporation of spilled fuel, thereby reducing the pollution potential of the substance." (128) Hydrophobic materials. "Are hydrophobic materials of low molecular weight and high vapor pressure exempt ­ they would not impact water quality (ie. [sic] tanks of propane)." (62) Mineral oil. Legislative intent. "The Agency should limit the definition of `oil' to petroleum and petroleum refinery products and exclude mineral oils and oils with a pour point above 60 degrees Fahrenheit from that definition." (125) Toxicity. We should exclude dielectric fluids from part 112 because they are used operationally in electrical equipment and have "more favorable toxicity characteristics" than most petroleum refinery products. (98, 125, 184) Mixtures. Bilge water. "In short, bilge water is not the same as oil. Accordingly, your regulation should expressly exclude bilge water from the same stringent requirements as are imposed upon oil spillage." (45) Brine and other substances. "The definition of oil does not refer to substances mixed with oil. A clarification must be made as to whether the proposed rules are intending to regulate just the handling of oil or the handling of oil and oil mixed with any other substance (e. g., brine tanks)" (154) Hazardous substances. "Are other hazardous substances potentially regulated by this statute (are) specifically exempt from SPCC requirements." (162) Volume, less than 10% oil. "GM believes the definition of `oil' should be amended to exclude solutions of materials containing low concentrations of oil, e. g., less than 10% by volume. Oil solutions of low concentration, if released, do not pose as great of a risk to the environment, as compared to concentrated oil solutions or compounds." (90) Non­ petroleum oils. 77 Include. "The definition of `oil' should specifically include non­ petroleum oils, such as animal and vegetable oils. These oils pose many of the same hazards in a spill situation as do the petroleum oils...." (27, 123) Exclude. "...( N) on­ petroleum based oils such as animal and vegetable fats and soils should be exempt from all oil 40 CFR 112 requirements." (56, 162) "It would make more sense to exclude animal/ vegetable oils and include petroleum products such as solvents which pose a much greater threat to the environment...." (L17, L26) Petroleum and its derivatives. Crude oil. We should define crude oil in part 112 "so that refined products such as diesel fuel and gasoline may be distinguished from unrefined crude oil." We should define crude oil as "an unrefined mixture of naturally occurring hydrocarbons produced from a well that is a liquid at a standard temperature of 60 degrees Fahrenheit and 14.73 psia." (58) Petrochemicals. Exclude. "For example, EPA should specify (with examples) that petrochemicals, such as xylene, are not included in the definition of `oil'." (103) Include. We should include only crude oil and refined petroleum products in our definition of oil. (66) Because we already regulate refined petroleum materials under other EPA programs (e. g., CERCLA Section 304, SARA Title III, RCRA Subtitles C and D), a broad definition of oil "will confuse industries about regulatory compliance and interdepartmental Agency responsibilities." (89) We should include only petroleum and "petroleum refinery products." (125, 189) Differentiate. "The term `refined petroleum products' ... needs sharpening. Not only are substances like fuel oil or diesel fuel or lubricating oils `refined petroleum products, ' but so are other substances which clearly are not oil­ like such as ethylene/ polyethelene, propylene/ polypropylene, styrene/ polystyrene which are ... clearly not oil­ like." (L26) Solid and gaseous oils. "We believe that those `oils' which are solids at ambient temperatures should not fall within the scope of this rulemaking. Such `oils' will not pose the same kind of water pollution `problem' as `true oils' and should be addressed separately." (33, 101, 102, 113) Synthetic oils. 78 Exclude. "As synthetic products, such liquids do not `fit EPA's definition of `oil' nor are they specifically addressed under the CWA. ... EPA should, instead, specifically exempt `synthetic oils and similar oil­ like liquids' that do not fit its `definition' of `oil' ...." (33) "Similarly, mineral oil dielectric fluids should be excluded because they too have low toxicity and are used operationally, even though they are petroleum based." (98, 125, 156) Transformer oil. If we decide to change the current definition, we should add transformer oil to the list of examples. (168) Used and waste oil. "The definition should be expanded to included [sic] used oils or the waste forms of all subject materials." (87) Vegetable oils, animal fats. Differences from petroleum oils. Clarification needed. Asks us to clarify whether vegetable and mineral oils are covered under part 112. (139) Exclude from rule. "ACMS believes that edible oils should not be governed by the OPA rulemaking." "The EPA should consider not applying these rules to the handling and storage of animal fats and oils, particularly those which are miscible in water." (51, 56, 137, 143) Differences. "The physical characteristics of vegetable oils such as corn oil are so markedly different that reliance on a narrow technical reading of the term `oil' is not credible." (37, 114, 137, 156, 175) "Edible oils do not create a hydrocarbon `sheen' on water surfaces as do petroleum oils. ... Edible oils are very biodegradable and present a negligible environmental threat to aquatic and animal life unless spilled in very large amounts in under unique circumstances. ... One option EPA should consider is providing needed flexibility in the SPCC rules would be to apply them as guidelines where specifically applicable to the edible oils industry." (137, 157) "The Department believes that EPA should consider developing regulations that respond to the types of oil that may be included within a facility." (175) Legislative intent. "... BHP believes that the Agency is making an unreasonable extension of the definition of oil to include such substances." (42, 56) Risk. "Unlike petroleum products, vegetable oils: are rapidly and completely biodegradable; pose no risk to human health if spilled in drinking water sources; are not flammable; are easily handled by POTWs. The only detrimental environmental impact from a major spill of vegetable oil would be temporary oxygen depletion in surface waters and its attendant effect on fish." (56, 137, 157). 79 State law (California). "We do not consider animal and vegetable oils to be subject to our oil pollution statutes. This difference is not fatal to our regulatory process as long as the states continue to have the flexibility of planning and regulating in this area without preemption." (193) Risk to the environment. Our failure to distinguish between oils based on potential to cause harm to the environment subjects owners or operators to unwarranted costs. (184) We should recognize that for different types of oils, the quantity necessary to cause irreversible environmental damage is different. (L2) Response: Support for proposal. We appreciate the commenters' support. We disagree that the definition of oil will subject additional facilities to SPCC requirements, and currently covered facilities to additional requirements. The definition does not expand what is oil, it merely clarifies which substances are included. Authority. We disagree that our authority only extends to petroleum­ based oils. Our interpretation is consistent with Congressional intent as expressed in section 311( a)( 1) of the CWA, which extends to all types of oils in any form. EPA's definition tracks that statutory definition. Our revised definition also reflects EORRA requirements for differentiation. EORRA did not expand or contract the universe of substances that are oils, it only required differentiation, when necessary, between the requirements for facilities storing or using different types of oil. What is oil. EPA interprets the definition of oil to include all types of oil, in whatever form, solid or liquid. That includes synthetic oils, mineral oils, vegetable oils, animal fats, petroleum derivatives, oil refuse, oil mixed with wastes other than dredged spoil, etc. We do not regulate products similar to oil (for examples, non­ oil chemicals), but only oil under part 112. A definition based on liquidity would exclude solid oils, such as certain animal fats, a result that would be inconsistent with Congressional intent. Concerning gaseous oils, see our discussion on Highly volatile liquids in the preamble to today's rule. Specific substances. Aromatic hydrocarbons. Aromatic hydrocarbons may or may not be oil, depending on their physical characteristics and environmental effects. Some aromatic hydrocarbons are hazardous substances. Asphalt cement. As to certain specific substances, asphaltic cement is oil because it is a petroleum­ based product and exhibits oil­ like characteristics. A discharge of asphaltic cement may violate applicable water quality standards, or cause a film or sheen or discoloration of the water or adjoining shorelines or cause a sludge or emulsion to be deposited beneath the surface of the water or upon adjoining shorelines. 80 Bilge water. Bilge water that contains sufficient oil such that its discharge would violate the standards set out in 40 CFR 110.3 is considered oil. The percentage of oil concentration in the water is not determinative for the purpose of the definition or the discharge standards. Crude oil. We did not propose a definition of the term crude oil in part 112, nor do we use it, except as an example of a discharge that may occur at an onshore drilling and workover facility (see §112. 10( c)). Therefore, we cannot finalize such a definition. Highly volatile liquids. We do not consider highly volatile liquids that volatilize on contact with air or water, such as liquid natural gas, or liquid petroleum gas, to be oil. Such substances do not violate applicable water quality standards, do not cause a reportable film or sheen or discoloration upon the surface of water or adjoining shorelines, do not cause a sludge or emulsion to be deposited beneath the surface of the water or upon adjoining shorelines, and are not removable. Therefore, there would be no reportable discharge as described in 40 CFR 110.3. Mixtures. Oil means oil of any kind or in any form, including, but not limited to: fats, oils, or greases of animal, fish, or marine mammal origin; vegetable oils, including oils from seeds, nuts, fruits, or kernels; and, other oils and greases, including petroleum, fuel oil, sludge, synthetic oils, mineral oils, oil refuse, or oil mixed with wastes other than dredged spoil. Other Federal and State rules. While our definition may differ from other Federal rules, it is necessary to implement the purposes of the CWA. RCRA. Although releases or discharges of some refined petroleum products may be regulated under the Solid Waste Disposal Act as waste products, that program is dedicated more to waste management, and does not regulate storage of nonwaste oil. The definition of petroleum in 40 CFR part 280 is a subset of the part 112 definition of "oil." The part 112 definition of oil is broader than the part 280 definition of petroleum because part 112 regulates all types of oils, whereas part 280 regulates only petroleum. State rules. While States may choose to regulate all oils or some oils, the CWA definition is designed to prevent the discharge of all oils. Public comment. In response to the recommendation that we present our definition for public comment, we agree. We did so in 1991 by publishing the proposed rule in the Federal Register. Risk to the environment. We disagree that in the definition of oil we should distinguish between oils by degree of risk or percentage of oil concentration. The risk or percentage of oil concentration does not change the fact that the substance is still oil and may harm the environment if discharged into it. We likewise disagree that we 81 should distinguish between oils by degree of risk for definitional purposes. The risk does not change the fact that the substance is still oil and may harm the environment if discharged into it. Finally, we disagree that we should exclude from the definition oil based on pour point, propensity to migrate off­ site, or viscosity factors. Any oil discharged to the environment may cause harm that the rule is designed to prevent. All oils, including animal fats and vegetable oils, can harm the environment in many ways. Oil can coat the feathers of birds, the fur of mammals and cause drowning and hypothermia and increased vulnerability to starvation and predators from lack of mobility. Oils can act on the epithelial tissue of fish, accumulate on gills, and prevent respiration. The oil coating of surface waters can interfere with natural processes, oxygen diffusion/ reaeration and photosynthesis. Organisms and algae coated with oil may settle to the bottom with suspended solids along with other oily substances that can destroy benthic organisms and interfere with spawning areas. Oils can increase biological or chemical oxygen demand and deplete the water of oxygen sufficiently to kill fish and other aquatic organisms. Oils can cause starvation of fish and wildlife by coating food and depleting the food supply. Animals that ingest large amounts of oil through contaminated food or preening themselves may die as a result of the ingested oil. Animals can also starve because of increased energy demands needed to maintain body temperature when they are coated with oil. Oils can exert a direct toxic action on fish, wildlife, or their food supply. Oils can taint the flavor of fish for human consumption and cause intestinal lesions in fish from laxative properties. Tainted flavor of fish for human consumption may indicate a disease in the fish which could render them inedible and thus have a substantial impact on the fishermen who harvest them and communities who may rely on them for a food supply. Oils can foul shorelines and beaches. Oil discharges can create rancid odors. Rancid odors may cause both health impacts and environmental impacts. For example, the 1991 Wisconsin Butter Fire and Spill resulted in a discharge of melted butter and lard. After the cleanup was largely completed, the Wisconsin Department of Natural Resources declared as hazardous substances the thousands of gallons of melted butter that ran offsite and the mountain of damaged and charred meat products spoiling in the hot sun and creating objectionable odors. The Wisconsin DNR stated that these products posed an imminent threat to human health and the environment. 62 FR 54526. Our revised definition also reflects EORRA requirements for differentiation. EORRA did not expand or contract the universe of substances that are oils, it only required differentiation, when necessary, between the requirements for facilities storing or using 82 different types of oil. Because at the present time EPA has not proposed differentiated SPCC requirements for public notice and comment, the requirements for facilities storing or using all classes of oil will remain the same. However, we have published an advance notice of proposed rulemaking seeking comments on how we might differentiate among the requirements for the facilities storing or using various classes of oil. 64 FR 17227, April 8, 1999. If after considering these comments, there is adequate justification for differentiation among the requirements for those facilities, we will propose rule changes. V ­10Partially buried tank Background: In 1991, we proposed to define a partially buried tank to clarify the distinction between such a tank and a UST. We proposed to define a partially buried tank as a storage tank that is partially inserted or constructed in the ground, but not fully covered with earth. We have renamed underground tanks in this rule as "completely buried tanks," i. e., those tanks completely covered with earth. A partially buried tank is an aboveground container for purposes of the part 112. Comments: The definition as proposed is "undecipherable" and should be rewritten. Suggests another definition for clarity. (121) We should adopt the part 280 UST definition for partially buried tank, which includes any tank system such as tank and piping which has a volume of 10 percent or more beneath the surface of the ground. (90, 180) Asks whether partially buried tanks will be subject to both parts 112 and 280, and if not, whether part 112 provides adequate regulation of leaks to the ground. (L17) Response: We agree that the definition could be clearer and have clarified it. We decline to adopt the part 280 UST definition (at 40 CFR 280.12) and to classify partially buried tanks as completely buried tanks, because they are not. The UST definition might also exclude some tanks or containers which would be covered by the SPCC definition. The UST definition includes tanks whose volume (including the volume of underground pipes connected thereto) are 10 percent or more beneath the surface of the ground. The SPCC definition of "partially buried tank" contains no volume percentage and applies to any tank that is partially inserted or constructed in the ground, but not entirely below grade, and not completely covered with earth. Therefore, some partially buried tanks will continue to be subject to both parts 112 and 280. We clarify that partially buried tanks may be covered not only with earth, but with sand, gravel, asphalt, or other material. The clarification brings the definition into accord with the coverings noted in the definition of "bunkered tank." We added a sentence to the definition noting that partially buried tanks are considered aboveground storage containers for purposes of this part. V ­11Permanently closed (See also section IV. C of this document) Background: In 1991, in §112.2( o), we proposed to define the term permanently closed to clarify whether facilities and tanks are excluded from part 112. In 83 §112.2( o)( 1), we proposed to define permanently closed as a tank and its connecting lines or a facility from which an owner or operator has removed all liquid and sludge, disposing of removed waste products in accordance with all applicable State and Federal requirements. Proposed §112.2( o)( 2) would have provided that to call a tank or facility permanently closed, an owner or operator must have tested the tank for and rendered the tank free from explosive vapor, using a combustible gas indicator, explosimeter, or other type of atmospheric monitoring instrument to determine the lower explosive limit (LEL). The proposed definition further would have provided that tank vapors must remain below the LEL, as defined by EPA and the Occupational Safety and Health Administration (OSHA). Proposed §112.2( o)( 3) would require blanking off all connecting lines, closing and locking valves, and posting signs warning that the tank is permanently closed and that there are no vapors above the lower explosive limit. Comments: Support for definition. "The inclusion of a definition of a `permanently closed tank' is helpful." (27). Opposition to definition. "It is recommended that the concept of `permanently closed' tanks be removed from the SPCC regulations. If a tank is not used for the storage of oil, it is simply not subject to the provisions of the SPCC regulations." (42, 67, 85, 86, 110, 125, 175) We should include in the term permanently closed those tanks without oil and with all connections severed. (101, 125, 165, 170, L2, L15) If our primary goal is to protect navigable waters, our definition of permanently closed is too stringent. (75, 86, 125, 155, 167, 170) Other substances. Our definition should include tanks that have been permanently closed and then loaded with liquid other than oil. (51) Regulatory criteria. "It is important that the Agency separate permanently closed tanks from regulated tanks and make the criteria easy to observe during SPCC inspections." (168, 190) Connecting lines. Support the proposed provision in the permanently closed definition to blank off all connecting lines. However, we should require that owners or operators blank off all connecting lines at both ends. (27, L12) We are overreaching our authority by requiring lines to be blanked off. (58) Asks that we clarify the term connecting lines. Assumes that we mean the sections of pipe that run between the tank and the nearest block valve. (67, 96, 102) Cost. It would be expensive to eventually close tanks currently in operation because owners or operators will have to pay for explosivity detection services, determination of LEL, placarding tanks, and waste disposal. (28, 31, 165) Decommissioned tanks. "The definition should include tanks which have been decommissioned in this manner. ... If the decommissioning procedure follows that prescribed by the procedure in the currently­ proposed `permanently closed' definition, a decommissioned tank no longer poses a threat of oil pollution." (L12) 84 Explosive vapors. "... (P) rovisions relating to combustible vapors or dust clearly fall outside the scope of the Clean Water Act." (42, 58, 67, 71, 75, 95, 102, 110, 125, 155, 167, 170, 175, L12) EPA should eliminate the 25% LEL because it is "NOT universally acceptable to OSHA." (33) Rather than render each tank free of explosive vapor, owners or operators should maintain tanks below the LEL for the tank's material. (33) Vapor testing for small tanks is excessive and should be necessary only for a tank with a capacity greater than 42,000 gallons or 1,000 barrels. (113) It would be difficult or impossible to remove all vapors, and we should delete this element from the permanently closed definition. (L2) Detection services would be too expensive. (L15) Signs. The proposed requirement to post a sign on permanently closed tanks is beyond the scope of our CWA authority. (58) "Additionally, the placement of a sign on a tank indicating that it has been gas freed is not a good safety practice. This could lead an inexperienced worker to believe that confined space entry without additional testing of the atmosphere within the tank is acceptable. This cold also apply to someone initiating hot work, such as welding or cutting, on the tank. If gases were to build up within the tank after the initial gas freeing procedure for some unexpected reason, a sign, such as that proposed, could have catastrophic results while providing no benefit." (67, 86, 102, 110, 175, L2) Retroactive enforcement. "The definition of `permanently closed' should not be applied retroactively to tanks that have been abandoned prior to adoption of this definition." Such tanks, in most instances, have been abandoned and empty for many years and pose no threat of an oil spill. It would be a severe economic burden to require that operators perform the proposed procedures on such a wide universe of tanks." The commenters did not provide specific cost estimates. (28, 31, 37, 101, 113, 165, L15) Scope of rule. The provisions to regulate permanently closed tanks are unclear. Asks whether we proposed to exclude permanently closed tanks from all of 40 CFR part 112. (84) Part 112 technical requirements should not apply to permanently closed tanks. (102) Temporarily closed tanks. Suggests "temporarily closed" definition." Temporary tanks should be excluded from the definition "provided the operator can show that the tanks have been shut­ in and all fluid removed down to the pipeline connection." (71, L2, L12) Waste disposal. Authority. "USEPA does appear to be within its statutory authority to require removal of all liquid and sludge from a permanently closed tank since, conceivably, such liquid or sludge, if released, could cause a discharge of oil in harmful quantities into a navigable water." (58) Opposition to proposal. 85 Other programs. "Waste disposal is covered under other programs and should not be a consideration for spill prevention unless flowable oil is part of the waste." (28, 31, 42, 101, 110, 165, 167, L15) Unnecessary. The definition is a "surreptitious means of inserting regulations with the definition section of 40 CFR part 112. ... (D) isposition of tank contents has nothing to do with the definition of a tank." (110) Sludge removal. "A small amount of sludge left on the bottom of the tank should not prevent it from being classified as empty." (75) "` Permanently closed' should not require the total removal of sludge unless the sludge is free flowing, provided that the provision for meeting explosive vapors can be met. It has been our experience that it can be very difficult to remove old sludge from #6 fuel oil tanks. It appears that the only way of removing the sludge is to dismantle the tank." (161) Response: Support for proposal. We appreciate commenter support. A definition is necessary to clarify when a container is permanently closed and no longer used for the storage of oil. Containers that are only closed temporarily may be returned to storage purposes and thus may present a threat of discharge. Therefore, they will continue to be subject to the rule. Connecting lines. We agree with the commenter's assumed definition of connecting lines. Connecting lines that have been emptied of oil, and have been disconnected and blanked off, are considered permanently closed. Cost. We have deleted the proposed requirements to render the container free of explosive vapor by testing to determine the LEL. We have also deleted all references to waste disposal. The sign noting that a container is permanently closed (with date of closure) should be relatively inexpensive. Decommissioned tanks. If "decommissioning" refers to the criteria for permanent closing of a container, then there is no need to include such terminology in the definition because permanent closure will include such tanks. Otherwise, the containers are not permanently closed and should not be included. Explosive vapors. We deleted proposed §112.2( o)( 2) on the suggestion of commenters that references to explosive vapors are an OSHA matter and inappropriate for EPA rules. We modified proposed §112.2( o)( 3) to eliminate the reference to signs warning that "vapors above the LEL are not present," because the operator cannot guarantee that warning remains correct. To help prevent a buildup of explosive vapors, we have revised the definition to provide that ventilation valves need not be closed. We agree with commenters that a sign might be misleading and dangerous. 86 Non­ oil products. Containers that store products other than oil and never store oil, are not subject to the SPCC rule whether they are "permanently closed" as defined or not. If the containers sometimes store oil and sometimes store non­ oil products, they are subject to the rule. Retroactive enforcement. We believe that containers that have been permanently closed according to the standards prescribed in the rule qualify for the designation of "permanently closed," whether they have been closed before or after the effective date of the rule. Containers that cannot meet the standards prescribed in the rule will not qualify as permanently closed. We disagree that the cost of such closure is prohibitive. We have simplified the proposal by deleting the proposed requirement to render the tank free of explosive vapor. Therefore, costs are lower. To clarify when a container has been closed, we have amended the rule to require that the sign noting closure show the date of such closure. The date of such closure must be noted whether it occurred before or after the effective date of this provision. Some States and localities require a permit for tank closure. A document noting a State closure inspection may serve as evidence of container closure if it is dated. Scope of rule. The exemption for a permanently closed container or facility applies to all of part 112. Waste disposal. Reference to waste disposal in accordance with Federal and State rules in proposed §112.2( o) was deleted as unnecessary surplus. EPA agrees that other programs adequately handle waste disposal. V ­12 Person Background: In the 1991 proposal, we proposed to include a definition of person that was substantively unchanged from the current rule. Comments: "EPA should either modify its regulatory definition of person, or make clear that the United States is bound by every provision of these regulations for any failure to comply." (35) Response: See the discussion under §112.1( c) for the applicability of the rule to Federal agencies and facilities. V ­13 Production facility Background: The definition of "production facility" replaces two definitions in the proposed rule, i. e., Oil drilling, production, or workover facilities (offshore), proposed §112.2( j), and Oil production facilities (onshore), proposed §112.2( k). We replaced the two proposed definitions with the revised definition for editorial brevity as the proposed definitions contained many identical elements. This editorial effort effects no substantive changes in the requirements for the particular types of production facilities. 87 Each facility must follow the requirements applicable to that facility, which is generally based on its operations, for example, a workover facility. Comments: Editorial change. "The proposed regulations contain new definitions for oil production facilities (onshore) and oil production facilities (offshore). These definitions should be replaced by a single definition of `production facility' that is identical to that found in 49 CFR §195.2. ... EPA should not develop new definitions for terms already defined in existing regulations that would result in wide spread confusion among the regulated community." (95, 102) We should include a definition for onshore drilling and workover facilities. The proposed definitions of the terms oil production facility (onshore) and oil production facility (offshore) are ambiguous, because of inclusion of the phrase, "may include." (154) Flowlines, gathering lines, wells and separators. "Oil production facilities should not include wells, flow lines, gathering lines or separators." (101, 165) "These pipelines (gathering lines) have never been subject to such (SPCC) requirements. They are truly transportation lines subject to Department of Transportation regulations." (71) "The term should also exclude oil gathering lines since it is virtually impossible to comply with certain provisions of the regulation without excessive and unrealistic expense. How, for example would an operator provide the necessary containment for his gathering lines pursuant to section 112.7( c)?" (113) Natural gas processing operations. Applicability of rules. "IPAA recommends clarification of the definition of `oil production facilities' at 40 C. F. R. §112. 2 to ensure that natural gas processing operations are treated as oil production facilities under the rules. That clarification should ensure the appropriate level of regulation for those related facilities and avoid inadvertent application of requirements designed for larger refining and marketing facilities to natural gas processing." (31, 86, L12) Risk. "After 20 years of SPCC regulation of E& P operated natural gas processing facilities, there is no evidence that demonstrates that these facilities have a different or higher risk of causing oil spill pollution of navigable waters. Therefore, the oil pollution requirements should not be different than those for other E& P facilities." (L12) Single geographical oil or gas field, single operator. "The inclusion of the phrases `in a single geographical oil or gas field' and `operated by a single operator' in this definition is confounding. The producing segment of the industry in some cases needs to be able to combine facilities into one SPCC plan with an identification of the wells to which that plan applies. We question whether the inclusion of the word `single' would preclude an operator's ability to do so." (167) Response: Editorial change. DOT definition. We changed the proposed definition to be more consistent with the DOT definition, found at 49 CFR 195.2, in response to a 88 commenter who urged consistency in EPA and DOT definitions. We added the uses of the piping and equipment detailed in the DOT rule to our proposal, for example, "production, extraction, recovery, lifting, stabilization, separation, or treating" of oil. The terms "separation equipment," used in the proposed definition of "oil production facilities (onshore)", and "workover equipment," used in the proposed definition of "oil drilling, production, or workover facilities (offshore)", were combined into a generic "equipment." However, we also modified the proposed definition to reflect EPA jurisdiction. We added the word "structure," which was not in the DOT definition, to cover necessary parts of a production facility. We also added examples of types of piping, structures, and equipment. These examples are not an exclusive list of the possible piping, structures, or equipment covered under the definition. The new definition encompasses all those facilities that would have been covered under both former proposed definitions. As we proposed in 1991, and as in the current rule, we have retained geographic and ownership limitations. Editorial change. We have eliminated the potential ambiguity caused by the words may include by substituting the word means. Flowlines, gathering lines, wells and separators. EPA disagrees that flowlines and gathering lines, as well as wells and separators, should be excluded from the definition. These structures or equipment are integral parts of production facilities and should therefore be included in the definition. We also disagree with the argument that because the installation of structures and equipment to prevent discharges around gathering lines and flowlines may not be practicable, EPA will be flooded with contingency plans. First of all, secondary containment may be practicable. In §112.7( c), we list sorbent materials, drainage systems, and other equipment as possible forms of secondary containment systems. We realize that in many cases, secondary containment may not be practicable. If secondary containment is not practicable, you must provide a contingency plan in your SPCC Plan following the provisions of part 109, and otherwise comply with §112.7( d). We have deleted the proposed 1993 provision that would have required you to provide contingency plans as a matter of course to the Regional Administrator. Therefore, you will rarely have to submit a contingency plan to EPA. The contingency plan you do provide in your SPCC Plan when secondary containment is not practicable for flowlines and gathering lines should rely on strong maintenance, corrosion protection, testing, recordkeeping and inspection procedures to prevent and quickly detect discharges from such lines. It should also provide for the quick availability of response equipment. Natural gas processing operations. Because natural gas is not oil, natural gas facilities that do not store or use oil are not covered by this rule. However, you should note, that drip or condensate from natural gas production is an oil. The storage of such drip or condensate must be included in the calculation of oil stored or used at the facility. Single geographical oil or gas field, single operator. 89 Single geographical oil or gas field. The phrase "a single geographical oil or gas field," may consist of one or more natural formations containing oil. The determination of its boundaries is area­ specific. Such formation may underlie one or many facilities, regardless of whether any natural or man­ made physical geographical barriers on the surface intervene such as a mountain range, river, or a road. Single operator. We disagree that the term "a single operator" is confusing. An "owner" or "operator" is defined in §112.2 as any "person owning or operating an onshore facility or an offshore facility, and in the case of any abandoned offshore facility, the person who owned or operated or maintained such facility immediately prior to abandonment." A "person" is not restricted to a single natural person. "Person" is a defined term in the rule (at §112.2) which includes an individual, firm, corporation, association, or partnership. V ­14 SPCC Plan or Plan (see also section X. A) Background: In 1991, we proposed to define an SPCC Plan or Plan to further explain its purpose and scope. Comments: Compliance. "An SPCC plan should not be a chronicle of actions taken to comply with the regulations. Rather, an SPCC plan should contain information which is necessary to prevent, control, or take countermeasures in response to a discharge of oil. Maintenance of records to demonstrate compliance is addressed in other sections." (42) Prevention v. Response. "Change the definition of `SPCC Plan' to "Spill Prevention and Response Plan' means a plan consisting of two separate entities: a Spill Prevention Plan (SPP or `plan'), described in sections 112.3 through 112.11 of this part, and a Spill Response Plan described in sections to be added." (121) Response: Compliance. We agree that the Plan does not document compliance, but merely spill prevention measures, and have deleted the sentence noting that the Plan documents compliance with the rule. Compliance is determined by comparing the contents of the Plan with the regulations. Prevention v. Response. In 1997, we proposed a new definition of an Spill Prevention, Control, and Countermeasure Plan, SPCC Plan, or Plan; and withdrew the 1991 proposed definition. See the preamble to today's final rule and the Response to Comments Document for the 1997 proposal for a discussion of the revised proposal. The 1997 proposal broadened the acceptable formats of SPCC Plans. In 1994, we finalized response plan requirements. V ­15 Spill event 90 Background: In 1991, we proposed to revise the definition of a spill event to make it consistent with the proposed changes in §112.1, reflecting the expanded scope of CWA jurisdiction. We proposed to define a spill event as a discharge of oil as described in §112.1( b)( 1). Comments: "` Spill event' should refer only to discharges to navigable waters." (28, 31, 101, 165, L15) "There is a great deal of confusion over the words: `spill, ' `spill events, ' and `discharges, ' `leak', etc. EPA should use this opportunity to define the term `discharge' as a reportable event under 40 CFR 110 and remove the term `spill event' from the regulations. The reason for this is that `discharge' is the word used in 40 CFR 110, and EPA should be consistent in the use of this important word. Then `spills, ' `leaks, ' `release, ' drips, ' etc. can be reserved for those events where oil escapes from some containment system, but does not get to water. This would be a great improvement over current terminology." (121) Response: We have withdrawn the proposed definition of "spill event," and have also deleted the term from the rule. We take this action because the term is not mentioned in the CWA and is unnecessary. The term is unnecessary because the word "discharge" is adequate. "Discharge" is the term used in the CWA. A discharge as described in §112.1( b) is the same as a spill event. V ­16 Storage capacity Background: In 1991, we proposed to define storage capacity to clarify the necessity of counting container capacity ­­ not the actual content ­­ in calculating the regulatory threshold. We stated that for determining the applicability of part 112, the storage capacity of a container means the total capacity of the container, whether the container is filled with oil or a mixture of oil and other substances. Comments: Opposition to proposal. "As proposed, if a vessel contains only trace amounts of oil, its entire volume must be included." (28, 31, 58, 67, 85, 86, 95, 101, 102, 103, 106, 113, 165, 167) Secondary containment containers. "The extremely broad definition proposed for `storage capacity' also could require that a tank or container that is used to provide secondary containment be considered when determining the storage capacity of a facility. This could discourage the installation of containers for use as secondary containment at small facilities that would otherwise be exempt from these regulations." (67, 85, 95) Waste treatment facilities. "Based on the proposed definition, the entire volume of any container including the non­ usable space at the top of the tank, containing trace amounts of oil must be used to determine applicability of these regulations. As a result, storage tanks used to store or treat wastewaters are likely to have to be considered when determining oil storage capacity since many wastewaters have incidental oil content prior to treatment. It is important 91 to note that the issue of tanks containing trace amounts of oil does not apply only to the petroleum industry. It is not uncommon for municipal stormwater runoff to contain trace amounts of oil due to runoff from parking lots and city streets. The proposed definition ... could result in these regulations being applicable to stormwater surge tanks used by POTWs due to the incidental oil content of stormwater runoff." (67, 72, 95) Standard of measurement. Bulk storage tanks only. "The proposed definition ... needs to be amended so that it is clear that only tanks or containers meeting the definition of a bulk storage tank, and only the oil storage capacity of that tank, need be considered." (67, 175) Design capacity. "Some electrical equipment which may fall under these regulations contain interior components which reduce the volume of oil contained. The design, not total capacity as might be measured by the dimensions unadjusted for these components, is more appropriately used in this situation." (183) Mixtures. "The proposed definition of `storage capacity' specifies that the total capacity of a tank is to be considered for the purpose of this regulation, regardless of whether the tank stores oil or an oil mixture. We strongly believe this clarification should become part of the final rule." (27) Oil­ water separators. Storage capacity should not include the capacity of flowthrough separators. (31, 165, L15) Volume. Volume is the proper measure of storage capacity, not total capacity. (160) Working capacity. Working capacity, "that is, the volume of the tank used for storage," should be the standard, rather than shell capacity. (86) Response: Support for proposal. We appreciate commenter support. Editorial changes and clarifications. We use the word "container" instead of "tank or container," because a tank is a type of container. We have clarified the definition to provide that the storage capacity of a container is the volume of oil that the container could hold, and have therefore substituted the words "shell capacity" of the container for "total capacity." This is merely a clarification, and not a substantive change. We also deleted the words "for purposes of determining applicability of this part," because the words were unnecessary. We also deleted the last phrase of the proposed definition, "whether the tank or container is filled with oil or a mixture of oil and other substances," because the contents of the container do not affect the definition of its shell capacity. 92 Exclusions ­ small containers; waste treatment facilities. Small containers. This definition is applicable to both large and small storage and use capacity. Owners or operators of small facilities above the regulatory threshold are subject to the rule, and need to know how to calculate their storage or use capacity. However, in the applicability section of the rule, we have excluded aboveground or completely buried containers of less than 55 gallons from the scope of the SPCC rule, addressing the comments of those commenters who argued for a minimum container size. See §112.1( d)( 5). A container above that size that is available for use or storage containing even small volumes of oil must be counted in storage capacity. Secondary containment containers. Containers which are used for secondary containment and not storage or use, are not counted as storage capacity. Standard of measurement. In most instances the shell capacity of a container will define its storage capacity. The shell capacity (or nominal or gross capacity) is the amount of oil that a container is designed to hold. If a certain portion of a container is incapable of storing oil because of its integral design, for example electrical equipment or other interior component might take up space, then the shell capacity of the container is reduced to the volume the container might hold. When the integral design of a container has been altered by actions such as drilling a hole in the side of the container so that it cannot hold oil above that point, shell capacity remains the measure of storage capacity because such alteration can be altered again at will to restore the former storage capacity. When the alteration is an action such as the installation of a double bottom or new floor to the container, the integral design of the container has changed, and may result in a reduction in shell capacity. We disagree that operating volume should be the measurement, because the operating volume of a tank can be changed at will to below its shell capacity. The keys to the definition are the availability of the container for drilling, producing, gathering, storing, processing, refining, transferring, distributing, using, or consuming oil, and whether it is available for one of those uses or whether it is permanently closed. Containers available for one of the above described uses count towards storage capacity, those not used for these activities do not. Types of containers counted as storage capacity would include flow­ through separators, tanks used for "emergency" storage, transformers, and other oil­ filled equipment. Waste treatment facilities. We agree with the commenter that a facility or part thereof (except at an oil production, oil recovery, or oil recycling facility) used exclusively for wastewater treatment and not to meet any part 112 requirement should not be considered storage capacity because wastewater treatment is neither storage nor use of oil. Therefore, we have exempted such facilities or parts thereof from the rule. However, note that certain parts of such facilities may continue to be subject to the rule. See the discussion under §112.1( d)( 6). V ­17 Wetlands (see also "navigable waters.") 93 Background: In 1991, we proposed to define wetlands, a term used in the definition of navigable waters. We noted that the proposed definition conformed with the part 110 definition. Comments: 1987 Wetlands Manual. "The definition of wetlands should conform to the definition in the `Federal Manual for Identifying and Delineating Jurisdictional Wetlands'." "We strongly urge that the definition of `wetlands' proposed in this rulemaking be either deleted or scaled back to the present definition set forth in 40 CFR 230.3. We suggest that deferral is required because the effort of the four agencies has received much more public scrutiny than this proposed rule, and EPA will have a better record upon which to base a definition that covers the entire range of programs, rather than one specific program as here." (64, 73, 78, 106, 145, 167, 175) Examples of wetlands. "The `Wetlands' definition includes a series of examples which may not be appropriate or correct and should be deleted." (64) Phreatophytes. " Phreatophytes, hydric soils, and saturation should be a part of the definition." (167) Expansion of definition. The proposed definition would significantly expand wetlands beyond what was in the delineation manual. (73, 106) "...( W) e deserve to know exactly what the rules hold in store for us. The jurisdiction of this regulation must be welldefined incorporating vague references to `wetlands' and `sensitive ecological area' is not acceptable to the agriculture industry and will no doubt pose serious enforcement problems to the Agency." (139) NPDES program. "Again, the protections provided by a regulatory permit program, as in the wetland regulations, are not necessary under the OPA, which seeks to identify and preclude the discharge of oil to `waters' from high risk bulk oil storage. Wetlands and other aquatic sites are adequately protected under the Clean Water Act. ... (N) avigable waters alone should serve as the jurisdictional trigger under the OPA." (35) Response: Examples of wetlands. The examples listed in the definition are intended to help the reader with guidelines to identify wetlands. While the examples generally represent types of wetlands, they are not intended to be a categorical listing of such wetlands. There may be examples listed that under some circumstances do not constitute wetlands. We believe that the 1987 Wetlands Manual is a useful source material for wetlands guidance. It would be impossible to specify in a rule every type of situation where wetlands occur. The examples listed in the definition are not exclusive, but provide help in clarifying what may be a wetland. Expansion of definition. We disagree that the definition expands the term "wetlands" beyond what is in the 1987 Wetlands Manual. It does nothing to substantively expand our jurisdiction over wetlands. 94 Rulemaking process. We disagree that we should not define "wetlands." While the NPDES program may define wetlands, the NPDES program and the SPCC program have different purposes, and a definition is needed for part 112. The definition is necessary to supply guidance to the regulated public. The definition of "navigable waters" includes wetlands, as defined in §112.2, because wetlands are waters of the United States. We note that 40 CFR 230.3 and the delineation manual serve different purposes than part 112. We believe that it is important to base the definition on the part 110 definition, because of the integral connection between parts 110 and 112. V ­ 18 Other definitions Background: Several commenters suggested definitions which we did not propose. Comments: Consistency in definitions. In general, we should make the definitions in part 112 consistent with corresponding definitions provided in other regulations. There is no justification for redefining terms specific to the SPCC regulation and to do so would cause "significant confusion." (167) Specific definitions requested. Connecting line. (113) Contingency plan. (82) Flow­ through process tank. We should define flow­ through process tank in §112.2. (28, 31,113, 165, L15) Good engineering practice. (33) Impervious. (27, L12) Oil production facility transfer operation. We should include a definition of oil production facility transfer operation in §112.2. (L12) Prevention, response, mitigation. We should define the terms prevention, response, and mitigation: provides suggested text. (121) Professional Engineer. (43) Response: Consistency in definitions. We agree that definitions in part 112 should be consistent with corresponding definitions in other regulations when it is appropriate. However, sometimes differing definitions are necessary to serve differing program goals. Specific definitions requested. For the suggested definitions not proposed, a dictionary or industry definition is sufficient. 95 Transfer operation. A transfer operation is one in which oil is moved from or into some form of transportation, storage, equipment, or other device, into or from some other or similar form of transportation, such as a pipeline, truck, tank car, or other storage, equipment, or device. 96 Category VI ­ Preparing and implementing Plans. VI ­ A: Time frames for preparing and implementing Plans ­ §112.3( a), (b), (c) Background: Section 112.3( a) of the current rule requires the owner or operator of a facility existing on or before the effective date of the rule that is subject to the rule to prepare and implement a Plan within one year after the effective date of the rule. In 1991, we proposed in §112.3( a) to require an owner or operator of a facility in operation on or before the effective date of the rule to prepare and implement a Plan within 60 days following that date. Section 112.3( b) of the current rule requires the owner or operator of a facility becoming operational after the effective date of the rule to prepare a Plan within six months after the facility begins operations and implement it within one year. In 1991, we proposed to require the owner or operator of a facility beginning operations more than 60 days after publication of the rule to prepare and fully implement an SPCC Plan before beginning operations. Section 112.3( c) of the current rule requires an owner or operator of a mobile or portable facility to prepare and implement a Plan as required under §112.3( a), (b), and (d). In 1991, we proposed to require an owner or operator of a mobile or portable facility to prepare, implement, and maintain an SPCC Plan as required under proposed §112.3( a), (b), and (d), noting that these owners or operators would not need to prepare a new Plan each time the facility is moved to a new location. Comments: Time period to prepare and implement a Plan. Support for proposal. "The proposed provision ... requiring that `a facility SPCC Plan be prepared and fully implemented before a facility begins operations... ' is commendable." "This is protective of the environment and consistent with many other environmental requirements." (43, 62, 80, 90, 121, 181, 185, and L11) Opposition to proposal. Re proposed §112.3( a): "Sixty days is not a practical time for compliance for Appalachian producers, who literally have thousands of sites throughout the seven Appalachian states." Re proposed §112.3( b): "It is recommended that the language of current §112.3( b), which allows six months for the preparation of the plan, be retained." (3, 23, 27, 34, 36, 42, 58, 66, 68, 71, 101, 107, 111, 113, 116, 134, 189) Implementation and training. Our proposal is impracticable because it does not allow new facility owners or operators enough time to implement the Plan and train the appropriate personnel. (66) Acquired facilities. "BFI would also ask the EPA to clarify how it would interpret this provision where an acquisition is being made. These acquired facilities under prior ownership may not have been aware of the SPCC rule and its provisions and hence 97 may not have put a plan into place. BFI would propose to the EPA that this does not constitute a `new facility' but an existing facility and that operations need not cease, while notification to EPA is being made and an SPCC Plan is developed and implemented." (23) Alternate time frames suggested Existing Plans. 180 days. (28, 36, 67, 68, 79, 85, 90, 91, 102, 107, 111, 116, 128, 134, 141) Next triennial review. "If EPA insists on making these small facilities comply with the proposed changes, then they should only be required to comply at the time of routine plan recertification, not before." (29, 58, 62, 78, 83, 101, 113, 116, 141, 145, 1164, 185, 189, L2, L14) Three years plus seven years. "A more realistic compliance period would be a minimum of three years for the preparation of plans with an additional seven years for the completion of necessary construction, if any." (98) 180 days or after updates. "We suggest that plans be allowed to be updated whenever a change occurs or when the next triennial review would occur, whichever is sooner." (71) 5­ 7 years. "A five to seven year phase­ in compliance schedule similar to the approach taken with EPA's underground storage tank program would be a more reasonable and achievable approach." (92) New Plans. 180 days. "It is recommended that the language of current §112.3( b), which allows six months for the preparation of the plan, be retained." (101) Cost. The costs associated with the proposal "cannot be justified in terms of the CWA or in anticipated benefits to the public. First, the start up volume associated with beginning operations at an onshore oil production facility is small. Thus, any discharge associated with commencement of operation would also be small. Second, the history of performance in the start up of a well is very good, both in terms of industry's standards and in terms of supervision by State regulatory authorities. Thus, even the small discharge which might occur is unlikely. Third, the cost associated with the engineer is disproportionately high when his services at a small operation (with low risk) are compared to similar costs at a large facility (where the risk is much higher). " (42) 98 Extensions. We should grant an automatic extension of six months, at a minimum, if the RA does not decide within 30 days of receiving the extension request. If an RA grants or denies an extension, we should require a Professional Engineer (PE) to certify that the RA's decision was made in accordance with "good engineering practice." (33, 42, 66,110, 133, 167, L12) Small facilities. Criticizing proposed requirement to have Plan developed and implemented before beginning operations, "... BFI urges that small facilities (e. g., those with 10,000 gallons or less of above ground oil storage) should be eligible for a reasonable time period to develop and implement this plan while operations occur. Although the EPA provided the potential for extensions from the Regional Administrator, these extensions are not automatic and the sheer burden to the Regional Administrator from numerous small facility requests would be unmanageable." (23) Mobile facilities. General Plans. We should allow a "strong generic spill contingency plan" for a mobile oil and gas production facility until the owner or operator can prepare and implement the SPCC Plan. Seeking an extension from the Regional Administrator (RA) could delay start­ up, and we should require the owner or operator of a mobile facility to prepare an SPCC Plan within 60 days after the facility begins operations. (68) Commends EPA for: "Retaining provisions in Section 112.3( c) that allow owners/ operators of onshore and offshore mobile or portable facilities to prepare a general plan for such a facility so that a new plan need not be prepared each time a facility is moved to a new site." (97) Multi­ well drilling program. "We question whether plan updates will be required in a field where a multi­ well drilling program is underway. Updates of the plan should be required only after the drilling program is complete." (167) No Plans. The definition of facility "contemplates a fixed structure, or unit, which serves a purpose at the place where it is fixed. Where equipment is mobile, its physical surroundings are subject to change. Conceivably, a SPCC Plan for a mobile `facility' would have to be amended each time the mobile equipment is moved. This is likely to be an unworkable requirement. For these reasons, mobile equipment should not be considered a facility for purposes of SPCC regulations." (188) NPDES coordination. We should coordinate SPCC regulation with the National Pollutant Discharge Elimination System (NPDES) storm water discharge permit system. (76) Start of operations. "Since many facilities initially become partially operational, defining the start of operations is not always clear. A better approach would be to require that a response team be in place and the notification portion of the plan be completed prior to 99 beginning operations and the entire plan to be completed within six (6) months of startup." (36) "Submittal." We should clarify the term submittal in the Preamble, because we do not require facility owners or operators to submit SPCC Plans to us under the regulation. (95, 101) Response: Time period to prepare and implement a Plan. Support for proposal. We appreciate the expressions of support for our proposal. We have been persuaded by commenters that a longer phase­ in period than 60 days is required for facilities currently in operation or about to become operational within one year after the effective date of this rule. Facilities currently in operation. For a facility in operation on the effective date of this rule, we changed the dates in the proposed rule for preparation and implementation of plans from 60 days to a maximum of one year to accord with the time frames in the current rule. The owner or operator of a facility in operation on the effective date of this rule will have 6 months to amend his Plan and must fully implement any amendment as soon as possible, but within one year of the effective date of the rule at the latest. The owner or operator of a facility which has had a discharge as described in §112. 1( b), or reasonably could be expected to have one, already has an obligation to prepare and implement a Plan. Facilities becoming operational within one year after the effective date of the rule (13 months following publication in the Federal Register). If you begin operations on or after the effective date of the rule through one year after the effective date of this rule (the effective date of the rule is 30 days after the Federal Register publication date), you will have until one year from the effective date of this rule to prepare and implement your Plan. In other words, if the rule becomes effective on January 1, and you begin operations on January 2, you must prepare and implement your Plan by January 1 of the following year. If you begin operations on June 30, you still have until January 1 of the following year to prepare and implement your plan. If you begin operations on December 31, you still have until January 1 (the next day) of the following year to prepare and implement your Plan. The rationale for the time frame in the rule is that you will have had notice of the Plan preparation and implementation requirements from the publication date of the rule, a period of 30 days plus one year. In addition, you would already have had notice of the general requirement for preparation of an SPCC Plan from the current part 112 regulations. Therefore, the owner or operator of a facility planning to become operational within one year after the effective date of this rule should start working on his Plan in time to have it fully implemented within the year. 100 New facilities. The owner or operator of a facility that becomes operational more than one year after the effective date of this rule must prepare and implement a Plan before beginning operations. Experience with the implementation of this regulation shows that many types of failures occur during or shortly following startup and that virtually all prevention, containment, and countermeasure practices are part of the facility design or construction. A year phase­ in period is in line with legitimate business and investment expectations. It allows a reasonable period of time for facilities to undertake necessary constructions, purchases of equipment, or to effect changes of procedures. And again, the general requirement for preparation of a Plan already exists in part 112, so new facilities should already have been aware of the need for a Plan. Acquired facilities. For SPCC purposes, we consider acquired facilities as facilities that are already operating rather than new facilities because these facilities must already have SPCC Plans if they exceed applicable thresholds. Cost. We disagree that the rule places a disproportionate impact on the regulated facilities, whether large or small. Most of the requirements of the rule are practices that many facilities would follow whether the rule required them or not. Not only have we fully assessed the costs for small entities, but the applicability criteria for part 112 also eliminate a number of small businesses from SPCC coverage. While amounts of oil stored may be small at some facilities, even a small discharge may be disastrous to the environment. We also disagree that small facility start­ ups cause fewer discharges than start­ ups at large facilities. Our experience shows the contrary; and the commenter presents no evidence for his assertion. We also disagree that the cost of PE certification at a small facility is disproportionate to that of certification at a large facility. A small facility is more likely to require a simpler, less expensive Plan that costs less to prepare and implement than a Plan at a large facility. Finally, we disagree that we should treat large and small facilities differently under §112. 3( b). Either type of facility may be the source of a discharge as described in §112.1( b). Extensions. While we have extended the time period for compliance, we understand that some facilities may still need extensions of time to comply. Extensions may be necessary to secure necessary manpower or equipment, or to construct necessary structures. If you are an owner or operator and an extension is necessary, you may seek one under §112.3( f). If no Plan amendments are necessary after you review today's rule, you must maintain your current Plan and cross­ reference its elements to the redesignated requirements. We disagree that we should grant an automatic extension of six months, at a minimum, if the RA does not decide within 30 days of receiving the extension request because compliance with the rest of the Plan that is not 101 affected by the extension request remains in effect. We also disagree that we should require a Professional Engineer (PE) to certify that the RA's decision was made in accordance with "good engineering practice." The RA has the assistance of PEs when necessary. Mobile facilities. We agree that the physical surroundings of mobile facilities are subject to change. However, we disagree that changing physical surroundings should exempt mobile facilities from the rule. Mobile facilities may have "general" Plans and need not prepare a new Plan each time the facility is moved to a new site. When a mobile facility is moved, it must be located and installed using the spill prevention practices outlined in the Plan for the facility. Mobile facilities currently in operation are assumed to have implemented Plans already, because they are currently legally required to do so. Both new and existing mobile facilities must have Plans prepared and fully implemented before operations may begin. If after your review of today's rule, you decide that no amendment to your Plan is necessary, except for cross­ referencing, you may continue to operate under your existing Plan, but you must promptly cross­ reference the provisions in the Plan to the new format. Extension requests under §112.3( f) are also available for mobile facilities under the proper conditions. Multi­ well drilling programs. It is not necessary to amend the Plan every time you drill a well in a field containing multiple wells. A general Plan will suffice. NPDES coordination. We allow use of a Best Management Practice Plan (BMP) prepared under an NPDES permit to serve as an SPCC Plan if the BMP meets all of part 112 requirements. When if does not, it may be supplemented. Therefore, we end duplicate paperwork requirements. Furthermore, under §§ 112.8( c)( 3) and 112.9( b)( 1), an owner or operator may, at his option, use records required under NPDES permit regulations to record stormwater bypass events for SPCC recordkeeping purposes. Small facilities. With the extended time line we have provided, all facilities, large or small, have adequate notice and time in which to prepare and implement a Plan. Start of operations. Start of operations is when you begin to store or use oil at a facility. Often this may be a testing or calibration period prior to start up of normal operations. With the extended time line we have provided, no response team is required, but such a team may be a good engineering practice. At a minimum, you must prepare and implement a Plan as required by this rule. "Submittal." The word submittal was incorrectly referred to in the rule. See 56 FR 54618. The commenters are correct that as a general rule, we do not require any owner or operator to submit a Plan. An owner or operator may be required to submit a Plan in certain circumstances, such as when a facility discharges oil over the threshold amount specified in §112. 4( a), or after on­ site inspection of the facility. 102 Training and implementation. We disagree that it is impracticable to train the appropriate personnel before start­ up. We note, however, that we have extended the time frame for Plan preparation and implementation beyond what we proposed. Thus, many facilities will have more time for training and implementation, and all facilities will be on notice of the new time frames, thereby allowing time to plan training and implementation before starting operations. 103 VI ­ B: Good engineering practice ­ §§ 112.3( d) Background: In 1991, we noted that good engineering practice is the applicable standard for all SPCC Plans. See §§ 112.3( d) and 112.7. We noted further that this principle requires an owner or operator to incorporate appropriate provisions of applicable regulations, standards, and codes into the Plan. Comments: Support for application of good engineering practice. "Chevron supports the flexibility of the current SPCC Program, which has allowed petroleum industry operations to adapt SPCC provisions at a particular site in accordance with `good engineering practice'." (96, 97) Deviations. "...( W) e recommend that EPA include in the applicability provision of the proposal, proposed §112.1, a statement that the purpose of the rule is to protect navigable waters from the risk of oil contamination and that implementation of the rule is based on good engineering practice. Specifically, we urge that this section provide that failure to conform to the specific requirements of the rule shall not be a violation where the owner or operator can demonstrate, in the exercise of good engineering practice, either that the alternative practices provide adequate protection against a reasonable risk of discharge to navigable waters or that compliance with the requirements would not contribute to protecting navigable water from a reasonable risk of discharge." (125, 170) Industry standards. "...( I) t is not always feasible or consistent with good engineering practice to mandate the same requirements for every facility." We should rely upon the discretion of local fire regulatory authorities, as we already recognize the model codes of such authorities as consistent with good engineering practice. We should recognize the spill and leak prevention methods of approved nationally recognized regulatory organizations as protection equivalent to our underground storage tank (UST) standards. Recommending such industry standards to owners or operators as guidance provides neither end users nor "entities charged with enforcing EPA standards" with enough specific guidance. We should recognize that the NFPA, BOCA, and UFC historically have regulated aboveground storage tanks (ASTs) of less than 6,000 gallons per tank and 18,000 gallons per site. Industry standards resulting from these regulations provide protection that is equivalent to our standards. (65) "If EPA wants the use of codes and standards to become part of part 112, then it must say so in the regulation (not the preamble). It must also say which codes will be required and under what circumstances they will be required. You cannot be vague about this." (121) PE rule certification. "At a minimum, such rules [SPCC] must contain a certification by a Professional Engineer that the rule and preamble have been reviewed by the certifying P. E. and represents Good Engineering Practice." (110) We should clarify our aim of grounding the rule on good engineering practice. (125) Response: Support for application of good engineering practice. We appreciate commenter support. We have maintained good engineering practice as the standard by 104 which to judge the propriety of various operating procedures, equipment, systems, and installations at SPCC facilities. Good engineering practice may include use of industry standards. Deviations. The purpose of the rule is "to prevent the discharge of oil from nontransportation related onshore and offshore facilities into or upon the navigable waters of the States or adjoining, shorelines, or into or upon the waters of the contiguous zone, or in connection with activities under the Outer Continental Shelf Lands Act or the Deepwater Port Act of 1974, or that may affect resources belonging to, appertaining to, or under the exclusive management authority of the United States (including resources under the Magnuson Fishery Conservation and Management Act.)." 40 CFR 112.1( a)( 1). In §112.7( a)( 2) of the final rule, we permit deviations from most of the substantive requirements of the rule when the facility owner or operator can explain his reasons for nonconformance, and can provide equivalent environmental protection by other means. Deviations from secondary containment requirements must be based on impracticability. 40 CFR 112.7( d). Good engineering practice. As we noted in the 1991 preamble (at 56 FR 54617­ 18), good engineering practice "will require that appropriate provisions of applicable codes, standards, and regulations be incorporated into the SPCC Plan for a particular facility." We agree with the commenter that the rule needs more specificity in this regard. Therefore, we have amended §112.3( d)( 1)( iii) to specifically include consideration of applicable industry standards as an element of the PE's attestation that the Plan has been prepared in accordance with good engineering practice. We reiterate today, as we did in 1991, that consideration of applicable industry standards is an essential element of good engineering practice. Industry standards include industry regulations, standards, codes, specifications, recommendations, recommended practices, publications, bulletins, and other materials. (See §112.7( a)( 1) and (j).) The owner or operator must specifically document any industry standard used in a Plan to comply with this section. The documentation should include the name of the industry standard, and the year or edition of that standard. However, as discussed above, we have chosen not to incorporate specific industry standards into the rule. Industry standards. We agree that "it is not always feasible or consistent with good engineering practice to mandate the same requirements for every facility." Therefore, we provide the owner or operator with authority to deviate from most of the rule's substantive requirements. See §112.7( a)( 2) and (d). We also encourage the use of industry standards when appropriate, instead of prescribed frequencies for inspections and tests. PE rule certification. We disagree that a PE should certify our rulemakings because such certification would not improve the rulemaking process. However, we do have the advice of PEs to help us with the process of rulemaking. 105 VI­ B­ 1 Industry standards Comments: Specific standards. If we want to incorporate industry codes and standards into part 112, then we should specify which codes and circumstances. (121) Industry standards inappropriate. "Further, EPA ... recommends Good Engineering Practice including `appropriate provisions of applicable codes, standards, and regulation be incorporated into the SPCC Plans for a particular facility. ' Typically these provisions require electricity. However, many existing tanks do not have and never will have electricity. Also, many new E& P facilities will not have electricity available because of the remoteness of the facilities. Further, I am concerned about who will make the decision as to which are `appropriate provisions'. ...( A) n industry P. E., after due consideration and visit to a facility, may be overruled by a non­ engineer as to what constitutes Good Engineering Practice. This is an abuse of bureaucratic discretion and makes a mockery of State licensing procedures." (110) Response: Specific standards. While we encourage the use of industry standards where applicable, we are not requiring an owner or operator to comply with specific industry standards or codes. Complying with industry standards or codes may be inappropriate under facility­ specific circumstances. Also, were we to incorporate standards and codes into part 112, these documents may become outdated before we could revise the rule. Further, if we incorporate a specific edition of a standard or code into part 112, we may prevent the application of advanced discharge prevention practices and technologies. Industry standards inappropriate. We do recommend that an owner or operator consider applicable standards and codes at existing and new facilities. This approach allows an owner or operator the flexibility to select a system or procedure that reflects good engineering practice. We have relegated all recommendations for the preamble and other guidance documents. In the final rule, we have amended §112.3( d) to specifically include consideration of applicable industry standards as an element of the PE's attestation that the Plan has been prepared in accordance with good engineering practice. VI ­ C PE certification requirement ­ §112.3( d) Background: In §112.3( d) of the current rule requires that a PE review and certify an SPCC Plan. Section 112.3( d) provides that in certifying the Plan, the PE (having examined the facility and being familiar with part 112 provisions) attests that "the SPCC Plan has been prepared in accordance with good engineering practices." In 1991, we proposed to add specificity in the rule to the elements to which the PE attests in certifying an SPCC Plan. These elements were that: the PE was familiar with part 112 requirements; he had visited and examined the facility for which he certified the Plan; the Plan was prepared in accordance with good engineering practice and part 112; required testing was complete; and the Plan was adequate for the facility. 106 Comments: Support for certification requirement. PE Plan review and certification ensures that the facility follows good engineering practice and has an adequate Plan. We should retain the current §112.3( d) text. (54, 67, 86, 97, 102, 105, 118, 155, 164, 182) Competence. We should require that the PE be qualified by education, training, or experience, since "most States prohibit licensees from engaging in work the engineer is not competent or qualified to perform." (L25) Opposition to certification requirement. Cost. "There are elements of the plan that a PE is typically not qualified to do, for example vulnerability analyses, and yet all plans are to be certified by someone with PE registration. This over­ emphasis on engineering qualifications is misplaced and will not guarantee one measure of extra protection for the environment. Such requirements add significantly to the cost of preparing SPCC plans without offsetting benefits." (109, 162, L2) Design v. Plan preparation. "EPA must not confuse facility design with SPCC plan preparation. While an engineer may need to design the facility (e. g., tanks, piping, etc.) A scientist is equally capable of describing the facility and developing appropriate emergency response procedures." (107, 176) Lack of expertise. A PE may not be "trained in the SPCC regulations" and may lack the ability to apply part 112 requirements in the field. (70) We should require certification by persons possessing "the necessary technical knowledge and skills to develop an effective Plan. ...( M) any PEs lack sufficient multidisciplinary knowledge and field skills to develop a site­ specific Plan adequate to address "all conceivable contingencies." (186) Other environmental professionals. PE can review work of others. We should modify the regulation to allow a site visit by a person under the direct supervision or authority of the PE who certifies the Plan. (67, 74, L4) A PE should not have to visit every facility. A PE who could not evaluate whether to visit a site should take a special test on part 112 before the PE can certify a Plan. Alternatively, if the PE does not conduct a site visit, he should state who provided the data and how. (76) Facility environmental professionals should continue to offer advice "without being encumbered with excessive, questionably beneficial educational and certification requirements." A Registered, independent, PE should certify the integrity of tanks, piping, containment structures, and other ancillary process equipment. (162) The rule "implies that a Plan or revisions to a Plan can be prepared by nonregistered individuals not associated with the PE and that the PE must only review the Plan before certification." (L25) 107 Other certifiers. "Many non­ engineers have been and are employed by government agencies to review the SPCC plans which they cannot legally certify. This inconsistency is inappropriate and should be eliminated." "Mitchell also recommends that the Agency consider accepting certification by a Registered Environmental Professional, as well as a Registered Professional Engineer. Either category of professional has training sufficient to evaluate the effectiveness of a SPCC Plan." (24, 31, 67, 71, 74, 76, 85, 86, 115, 186) We should permit certification by "a degreed geologist/ hydrologist with five years experience, a degreed engineer with five years experience, or a registered PE ." (70) "Facility superintendents, geologists, planners, geographers, hydrologists, and people with many other qualifications can do the work with at least the same insight and of the same quality as a PE." (109) Owner/ operator discretion suggested. "Because the facility owner assumes all liability associated with the adequacy of the facility design and SPCC plan, the EPA should not be involved in specifying who must certify it." (107) "Questar strongly recommends that facility owners/ operators be the certifying authority for the plans (and amendments thereto) and that they be trusted to recognize their own interests and employ qualified persons to prepare the plans. If EPA rejects that suggestion, we recommend that PE certification and review be eliminated for smaller facilities." (109) PE unnecessary. "IPAA would like to note that if all of the components of the SPCC Plan are prescribed by regulations, there is little use in review and certification by a Registered Professional Engineer." (31, 86, 149, 176) The PE certification requirement is "unwarranted." PE certification would not ensure "adequate protection of the environment" and is inconsistent with other Federal emergency response plan preparation requirements ­­ including Resource Conservation Recovery Act (RCRA) Contingency planning requirements. (107) The Regional Administrator (RA) "usurps" the need for a PE, and we should only use the PE as a "reliable purveyor of good engineering practice unfiltered by unnecessary regulations." (110) "... Arvin believes that tanks, piping, containment structures, and other ancillary process equipment be certified as to its integrity by a registered, independent, professional engineer. However, development of SPCC plans, etc., requires a great deal of common sense, a working knowledge of the facility, knowledge of regulatory requirements and guidelines, etc. None of these requirements indicate a need for a PE." (162) Federal and most State hazardous waste management regulations have no requirement for a PE to develop a contingency plan. (176) PE Plan certification is unnecessary, because we already require owners or operators to follow good engineering practice. (L27) Small facilities. "PTL agrees that a registered professional engineer (P. E.) should review and certify SPCC plans which are required for facilities that store in excess of 42,000 gallons aboveground. We do not agree that a PE is needed 108 to review and certify a SPCC plan which has a storage capacity less than 42,000 gallons. Our reasoning is that facilities that store less than 42, 000 gallons do so with multiple tanks which typically consist of 5, 000 to 10,000 gallons in capacity. These tanks are required to contain the Underwriters Laboratory Seal of Approval prior to installation. Moreover, state and local fire marshal's office require detailed plans be submitted to their office prior to installation of these systems. Therefore, it does not seem cost effective to have a registered engineer develop a plan to ensure the integrity of these systems that have already been scrutinized by state and local agencies." (82,109,124,166) Applicability of requirement. We should insert in §112.3( d) language "to convey the thought that the P. E. certification pertains only to compliance with SPCC requirements...." (8) No State registration. "American Samoa is a Territory of the United States located in the South Pacific approximately 2, 400 miles from the State of Hawaii, with a population of approximately 47,000. As a result, the Government of American Samoa does not register Professional Engineers. Therefore, compliance with the proposed SPCC certification would be impossible." (L21) Certification eligibility. "It appears that any registered engineer can certify a Plan. Most states, if not all, have rules of professional conduct that prohibit licensees from engaging in work the engineer is not competent or qualified to perform by reason of education, training, or experience." (L25) Dates, status, etc. "The certification attesting to an examination of the facility by the PE should include the date( s) of the examination and the topics addressed during the examination, and the status of construction and other site preparations as of the date( s) of the examination." (43) Editorial clarifications. "The term `Registered' is not used in the Michigan Professional Engineer (PE) Act, and perhaps in other states as well, inasmuch as PEs are now `licensed' rather than registered to practice engineering. Thus I recommend that the word `Registered' be deleted wherever it is used immediately before the words `Professional Engineer' in this regulation...." (43) We should clarify the rule language by stating "that the Engineer shall attest that... he/ she has examined the facility." (121) Knowledge, information, and belief. We should clarify in §112.3( d) that in certifying a Plan, the PE makes the §112.3( d) attestations "to the best of the Engineer's knowledge, information, and belief." (24) Liability. We should amend the rule to protect a PE from legal liability for performance under §112.3( d), except for gross negligence or willful misconduct. Because we do not require PE certification for the facility design, a PE may certify a poorly designed facility. (24) 109 PE Audit. We should require a PE audit the facility just before a facility begins operation to determine whether "all elements of the SPCC Plan are in place" and whether "the facility's personnel have been trained to deal with spills." (43) State registration laws. We should solicit information from the National Council of Examiners for Engineering and Surveying (NCEES) on State variations in PE registration laws to help modify part 112. (26) Time limit for PE certification. "A time limit of less than three (3) years should be placed on the validity of the PE's certification. EPA should require that the PE reinspect the premises periodically, preferably annually, to ascertain that the SPCC Plan continues to be fully implemented." (43) Existing certifications. Requests "that it be clarified that existing SPCC plans are grandfathered from the PE visitation/ recertification requirements until plan updates are required." (167) Response: Support for certification requirement. We appreciate commenter support for the PE review and certification requirement. PE certification of all facilities, both large and small, is necessary because a discharge as described in §112.1( b) from any size facility may be harmful, and PE review and certification of a Plan may help prevent that discharge. Because a Plan for a smaller facility is likely to be less complicated than a Plan for a larger facility, PE certification costs should likewise be lower for a smaller facility. In our Information Collection Request, estimated total costs for a new facility to prepare and begin implementation of a Plan, including PE certification costs, are $2, 201 for a small facility, $2, 164 for a medium facility, and $2, 540 for a large facility. This cost is incurred only in the year that the facility first becomes subject to the rule. This one­ time cost incurred by a small facility is less than 1. 5 percent of the average annual revenue for small facilities in all industry categories. The cost for the PE certification alone would represent even less than that. As shown in Chapter 5 of the Economic Analysis for this rulemaking, the average annual revenue for the smallest regulated facilities (under the current rule) ranges from $150,000 to $6,833,000, depending on the industry category. For example, farms with annual revenue between $100,000 and $249,999 have an average annual revenue per farm of $161,430, and $2,201 (the one­ time cost to prepare and implement a Plan) represents only 1. 36 percent of that annual revenue. Of course, under the revised rule many of these small facilities will not be regulated by the SPCC program at all. A PE's certification of a Plan means that the PE is certifying that the facility's equipment, design, construction, and maintenance procedures used to implement the Plan are in accordance with good engineering practices. And this is important because good engineering practices are likely to prevent discharges. PE certification, to be effective for SPCC purposes, must be completed in accordance with the law of the State in which the PE is working. For example, some States require a PE to apply his seal to effectuate a certification. Others do not. 110 We disagree that the Regional Administrator (RA) "usurps" the need for a PE. The RA does not review or certify an SPCC Plan, as does the PE. Therefore, there is no overlap between RA and PE responsibilities in the SPCC Program. The PE is crucial to designing a facility­ specific Plan for each facility that accords with good engineering practice. His certification is necessary to document that the Plan was prepared in accordance with good engineering practice. We also disagree that small facilities need not have PE certification for SPCC Plans when the tanks are certified by the Underwriters Laboratory. A Plan consists of more than a certified tank. It contains provisions for secondary containment, integrity testing, and other measures to prevent discharges. Those provisions require PE certification to ensure that they meet the requirements of the rule and that the Plan is effective to prevent discharges Applicability of requirement. We reaffirm that PE certification requirement in part 112 pertains only to compliance with SPCC requirements. No State registration. In response to the commenter from Samoa, who noted that territory does not register PEs, the rule would allow an SPCC facility there to hire a PE licensed in some other State or U. S. territory. Dates, status, etc. The certification must be dated because the date is necessary to detail compliance with Plan implementation requirements. We disagree that the attestation need contain examination dates, topics addressed, and status of construction and other site preparations. Those items are more appropriately addressed in the Plan itself or for a log or appendix to the Plan. Editorial clarifications. Editorial clarification. No editorial change is necessary because the owner or operator is already required to make the Plan available for on­ site review. See §112.4( d). We agree that the correct term is "licensed Professional Engineer," rather than "Registered Professional Engineer," and that is the term we use in the rule. Knowledge, information, and belief. We agree that the PE attests "to the best of his knowledge, information, and belief," but do not believe that additional rule language is necessary because the language is already implicit. We note that the attestation requires no specific formula, merely documentation of compliance with the required elements. Liability. We disagree that we should amend the rule to protect a PE from legal liability for performance under §112.3( d), except for gross negligence or willful misconduct. PE liability, is and should remain, a matter of State law. Other environmental professionals. Certification by a PE, rather than by another environmental professional is necessary to ensure the application of good engineering 111 judgment. Likewise, we disagree that we should permit an owner or operator to certify the Plan and technical amendments, or that we should eliminate PE Plan review and certification for smaller facilities. As described above, PE certification helps ensure the application of good engineering practice. We agree that a PE should be qualified by education, training, or experience, and note that "most States prohibit licensees from engaging in work the engineer is not competent or qualified to perform." A PE must obtain a Bachelor of Engineering degree from an accredited engineering program, pass two comprehensive national examinations, and demonstrate an acceptable level (usually four additional years) of engineering experience. A licensed engineer is also required to practice engineering solely within his areas of competence and to protect the public health, safety, and welfare. We also believe that prescribing the credentials for a PE should be a matter of State, not Federal law. Licensing criteria may differ somewhat among the States. All licensed PEs, no matter who their employer, are required by State laws and codes of ethics to discharge their engineering responsibilities accurately and honestly. Furthermore, State governments have and do exercise the authority to discipline licensed PEs who fail to comply with State laws and requirements. Other environmental professionals may not have similar expertise nor be held to similar standards as the licensed PE. PE Audit. We also disagree that we should require a PE audit the facility just before a facility begins operation to determine whether "all elements of the SPCC Plan are in place" and whether "the facility's personnel have been trained to deal with spills." Those tasks are the responsibility of the owner or operator, not the PE. PE certification does not relieve an owner or operator of a facility of his duty to prepare and fully implement the Plan in accordance with part 112 requirements. 40 CFR 112.3( d)( 2). State registration laws. We disagree that we should solicit information from the National Council of Examiners for Engineering and Surveying (NCEES) on State variations in PE registration laws to help modify part 112 because such information is not necessary to the implementation of the SPCC program. PE registration, is and should remain, a matter of State law. PE certification, to be effective for SPCC purposes, must be completed in accordance with the law of the State in which the PE is working. For example, some States require a PE to apply his seal to effectuate a certification. Others do not. Time limit for PE certification. We disagree that there should be a time limit on PE certification because the rule ensures that the PE reviews the Plan at appropriate times. We also disagree that we should require periodic PE reinspection of a facility. Thus, current PE certifications remain valid. But new certifications after the effective date of this rule must include the required attestations. If you are an owner or operator you must review your Plan at least every five years (under revisions made in today's rule), and amend it if new technology is warranted. Also, you must amend your Plan to conform with any applicable rule requirements, or at any time you make any change in facility design, construction, operation, or maintenance that materially affects its potential for a discharge as described in §112.1( b). All material amendments require PE certification. Therefore, because a Plan will likely require one or more amendments 112 requiring PE review and certification, a time limit on PE certifications is unnecessary. See §112.5( c). 113 VI ­ D: Whether the certifying PE may be a facility employee or have any direct financial tie to the facility ­ §112.3( d) Background: In the 1991 preamble, we requested comments on whether the certifying PE should be an employee of the owner or operator, or have "any other direct financial interest in the facility." The rationale for this proposal was to avoid conflicts of interest or the appearance of a conflict of interest between a facility owner or operator and the PE. Comments: Support for independent PE. Conflict of interest. "I believe that specially with SPCC planning and implementation is valuable for the certifying P. E. not to be an employee of the company so that he can be more objective and thus help in arriving at decisions which will help assure that the objectives of this regulation are achieved." (21, 121, 142, 168, and L8) "On the other hand the employee engineer may be reticent because of job position or other reasons about recommending major facility modifications, if these are determined to be necessary during development or review of a plan." (16, 21, 121, 142, 158, L8) More economical. "Also, many companies are now finding that it is more economical to engage a SPCC trained and competent P. E. who is not an employee, rather than train an employee in the requirements specified by the SPCC regulations." (21) More objectivity. "I believe that specially with SPCC planning and implementation it is valuable for the certifying P. E. not to be an employee of the company so that he can be more objective and thus help in arriving at decisions which will help assure that the objectives of this regulation are achieved. The private practice P. E. can, without fear of losing his pension, benefits, job, etc., be an objective and cooperating individual who assists the owner and the regulating agencies and thereby satisfies his duties more comfortably of serving the public." (21, 168, L8) Opposition to independent PE requirement. Ethics. "To suppose that a facility employee would break the law and jeopardize his license to practice his profession and do it more willingly than an `independent' engineer has no basis in fact and is perhaps diametrically opposed to real world realities." "Regarding financial interest, an independent engineer may have just as great, if not more, financial interest in accommodating the facility operator/ owner." (5, 6, 9, 14, 15, 16, 23, 24, 31, 34, 35, 36, 39, 40, 41, 51, 52, 54, 56, 58, 59, 67, 71, 72, 74, 80, 88, 90, 92, 96, 98, 103, 105, 110, 113, 114, 115, 117, 125, 126, 131, 133, 135, 136, 141, 143, 146, 155, 161, 165, 167, 170, 173, 175, 180, 181, 183, 184, 189, 190, L4, L9, L15, L19, L20, L25, L30, L31, L32) 114 Enforcement mechanisms. EPA enforcement. "EPA can also take enforcement action for false certifications." (35) "EPA should adopt an enforcement policy for taking action against the licence of a PE if the performance of the PE is not consistent with professional standards, or is negatively biased by the PE's relationship to an operator." (52) "Abuses of the certification function should be subject to administrative fines just as are other violations of the rules. This is a better method of ensuring proper certification, rather than trying to limit the use of all employee PEs." (71, 96) State law. "State laws and regulations establish adequate complaint procedures and penalties for violations of the standard of practice to which Professional Engineers are held." (5) "EPA should not legislate in areas of state concern, such as requirements that constitute appropriate engineering practices." (35) "Professional engineers are registered by state engineering boards, which are responsible for overseeing their ethics and technical qualifications. As a result, all professional engineers are expected to uphold the same professional standards, regardless of the entity who employs them or any other direct financial interest in the facility." (146) Familiarity with facility. "Depriving the owner of the use of his own engineer would in many instances exclude the most qualified person from producing the plan. The result may well be that the average new plan will be inferior to those already in existence." (5, 6, 25, 31, 38, 47, 53, 59, 62, 71, 72, 74, 75, 77, 78, 80, 86, 88, 89, 90, 92, 98, 101, 105, 112, 116, 124, 133, 135, 136, 137, 141, 143, 145, 146, 153, 155, 160, 161, 164, 165, 167, 173, 180, 181, 183, 191, L3, L7, L14, L15, L29) Financial burden. "The requirement of hiring an independent engineer would also place a tremendous financial burden on facility owners. ... A further substantial source of financial burden would be in revising a plan previously written by an independent engineer." (6, 9, 10, 27, 28, 34, 35, 38, 41, 42, 47, 48, 54, 62, 68, 71, 79, 90, 91, 93, 98, 103, 105, 110, 112, 115, 125, 134, 136, 137, 139, 141, 146, 153, 155, 160, 167, 173, 175, 181, 182, 183, 188, 190, 191, 192, L2, L3, L14, L18, L20, L29, L31) Insurance. "We are also concerned whether an independent PE could really afford the insurance to certify his work." (71) Financial interest, inside and outside PEs. Outside. "Merely by contracting with the facility to review and certify SPCC plans, the PE is engaging a financial interest in the operation." "The premise that an employee of a facility has a financial interest in the company, but that a 115 consultant PE under contract to the facility does not, is incorrect. A consultant PE also receives payment from the facility for his/ her work. The difference between the employee PE and the consultant PE is simply that a consultant's services are over once the service has been provided. If a consultant PE does not render satisfactory service, he/ she may not be retained in the future." (6, 27, 47, 52, 76, 77, 95, 102, 116, 125, 136, 164, 165, 181, 187, 189, L14, L15) Inside. "We believe, moreover, that the `independent' engineer proposal ignores the fact that `independent' engineers may also have conflicting financial interests that could lead to bias. Retained experts, after all, have a strong interest in satisfying clients in the hope of renewed retention on future company projects. A tenured company engineer may have greater job security and face less risk of dismissal for professional independence than a retained expert who has no assurance of retention on future company projects requiring engineering services." (125) Compromise position. "Perhaps the compromise here is that the PE who certifies the SPCC Plan be required to disclose in the SPCC Plan certification his or her relationship to the facility owner, the facility improvement owner, and the facility landowner." (47) Direct financial interest. We should clarify the definition of the phrase "other direct financial interest." (87) Response: We agree that a proposal to restrict certification by a PE employed by a facility or having a financial interest in it would limit the availability of PEs, possibly leading to delays in Plan certification. Therefore, we will not adopt it. Nor do we favor the proposal to require the PE to disclose his relationship to the facility owner, the facility improvements owner, or the facility landowner. Such disclosure would add no environmental protection to the SPCC certification process. We agree that there are mechanisms in place to enforce ethical conduct by PEs. State licensing boards expect PEs to uphold professional standards and can discipline PEs for unprofessional conduct. State administrative action to correct abuses may be an appropriate approach. We believe that most PEs, whether independent or employees of a facility, being professionals, will uphold the integrity of their profession and only certify Plans that meet regulatory requirements. We also agree that an in­ house PE may be the person most familiar with the facility. EPA believes that a restriction of in­ house PE certification might place an undue and unnecessary financial burden on owners or operators of facilities by forcing them to hire an outside engineer. Direct financial interest. Because we have not adopted a requirement for an independent PE, it is not necessary to discuss what is a "direct financial interest." 116 VI ­ E: PEs ­ State registration ­ §112.3( d) Background: In the preamble to the 1991 proposal, we requested comments on the advantages and disadvantages of requiring a certifying Professional Engineer (PE) to be licensed in the State where the facility is located. Comments: Support for proposal. Familiarity with local rules, conditions, etc. "Familiarity with the state and local requirements related to the facilities as well as the state itself are essential for viable SPCC plans. This is particularly true in Alaska when considering our unique geography and climate." (43, 52, 54, 77, 111, 134, 142, 143, 153, 158, 159, 185) Implementation. If a PE prepares a facility Plan in a State where the PE is not registered, another PE who is registered in the State should certify the Plan. (159, L25) Diligent efforts. While the certifying PE should be registered in the State where the facility is located, the owner or operator should be able to use a PE registered in another State if after the diligent efforts, the owner or operator cannot find a PE registered in the State to certify the Plan. (51) State licensing boards. "State laws and regulations establish adequate complaint procedures and penalties for violations of the standard of practice to which Professional Engineers are held." (4, 5, 14, 23, 40, 42, 43, 71, 72, 76, 80, 86, 121, 128, 143, 154, 173, 190, L4, L17) Opposition to State licensing requirement. Cost. "Additional requirements for same­ state registration or financial independence of the Engineer would place a greater burden on the regulated community without providing greater benefits to the SPCC program." (10, 15, 27, 31, 34, 48, 57, 59, 65, 68, 78, 79, 86, 87, 103, 109, 112, 116, 125, 137, 150, 160, 175, 182, 191, L3, L30) Familiarity with State and local requirements. "Furthermore, being certified in a particular state does not necessarily mean that the engineer has significant professional experience in the state. Because many of today's professionals are mobile and prone to transfers, it is not uncommon for a professional engineer to spend most of his working career in states other than the one where he received his certification. Also, because of reciprocal agreements between certification boards in different states, it is possible to obtain certification in a one sate by virtue of having been certified in a different state. Clearly, certification in a particular state does not automatically mean that the engineer is more familiar with that state's codes and regulations than any other professional engineer." 117 (9, 27, 31, 34, 36, 39, 42, 48, 54, 56, 57, 59, 62, 66, 67, 72, 78, 86, 87, 89, 90, 95, 101, 102, 103, 105, 109, 112, 114, 124, 125, 128, 130, 133, 136, 137, 143, 145, 150, 152, 160, 165, 167, 170, 173, 188, 190, 191, L29, L30, L32) No environmental benefit. "First, requiring that the professional engineer that certifies a given plan be registered in the same state as where the facility is located provides no additional pollution prevention. The exams that are administered as part of the certification process for a professional engineer deal with engineering concepts. The vast majority of these exams are standardized and do not address state specific issues, such as codes and regulations. Therefore, certification within a given state does not necessarily mean that the engineer is more familiar with the codes and laws of that particular state." (71, 95, 102, 114, 145, 167, 170, 173, 175, 182, L29) State licensing boards. "A State licensing board will address the actions of an engineer licensed by that board regardless of the engineer's location when he applies his seal." (75, 79, 80, 95, 102, 110, 113, 136, 155, 175, 182, 184, L7, L9, L32) Would reduce the pool of available PEs. "Because of the antiquated nonreciprocal licensing laws which exist among most of the states, it is practically impossible (and certainly not cost effective) for a professional engineer to be licensed in every state." (15) Response: We agree with commenters that it is unnecessary that the PE be registered or licensed in the State in which the facility is located because any abuses will be corrected by the licensing jurisdiction. We also agree that such a requirement might unnecessarily reduce the availability of PEs and increase the cost of certification without any tangible benefits. The professional liability of a PE would likely be unaffected by the place of his registration. When State law precludes a PE from applying his seal if he is not licensed in that State, the question of State registration becomes moot. However, that is not the case in every State. We also disagree that if a PE is not licensed in the State, he will be unfamiliar with State and local requirements for the facility. Any PE may become familiar with both Federal and State and local requirements for a facility. Therefore, to require that the PE be registered in the State in which the facility is located would impose unnecessary financial burdens on the facility and would challenge the integrity of the PE. Such a requirement would also reduce the pool of PEs available for facilities. VI ­ F: PEs ­ Site visits ­ §112.3( d) Background: Under §112.3( d) of the current rule, a PE must attest that he has "examined the facility" before certifying that facility's SPCC Plan. In 1991, we proposed to clarify that the PE must examine the facility in person. 118 Comments: Support for proposal. "The language changes in the proposed regulation clarifies the requirement that the certifying engineer must physically visit the facility. Ohio EPA agrees with this change." (15, 27, 39, 52, 74, 75, 80, 95, 102, 121, 136, 141, 158, 161, 168, 175, L29) Good engineering practice. "Prior to preparing or re­ certifying an SPCC plan, it is agreed that a site visit is absolutely necessary. The certifying PE is able to review all aspects of the plan with local management and leave with reasonable assurance that the facility would be able to prevent and/ or respond to any spill event. Spill clean­ up and retention equipment should be inspected as well as response personnel training." (15, 39, L29) Opposition to proposal. (9, 24, 28, 35, 36, 58, 65, 67, 71, 76, 78, 82, 87, 101, 113, 115, 116, 134, 145, 165, 183, 192, L4, L15, L30) Available documentation. "A PE is expected to have the proficiency to comprehend the requirements of the rule and assess the completeness of the plan for the facility based on available information and technical backup." (28, 87, 101, 115, 116, 165) A PE site visit will not materially improve the Plan. The PE can use topographic maps, photographs, and other methods to make an informed decision. (87) A site visit "may not provide any better information than if the facility was required to provide a professional engineer geographical and geological information that depicts land and water within one­ quarter mile of the facility boundaries." (115) A visit is unnecessary at small facilities with adequate drawings, photos, or other documentation. (116) Cost. "Site visits to physically examine the facility would involve additional direct cost and duplication of efforts with possibly no benefits on the overall effectiveness of the plant." (9, 28, 36, 65, 82, 101, 145, 165, L30) The site visit cost is unnecessary if the PE is "familiar" with the facility. (36) A site visit imposes substantial additional costs since many entities use vaulted aboveground storage tanks at remote locations to support transmitter sites and backup generator sites. (65) "Many sites scattered throughout Appalachia are remote, access is difficult, and travel time expensive. This requirement places an enormous burden in terms of increasing the cost for the SPCC plan. The engineer should be able to understand the adequacy of the construction in the containment plan from the documents provided. The Registered Professional Engineer can request additional documentation if the engineer deems it so necessary." (101, 115, 145, 165) Electrical equipment. Due to the large number of station, "it would be impractical for the certifying PE to visit and inspect each site when preparing SPCC Plans." (134, 183) Multiple sites. It is difficult for the certifying PE to visit multiple facilities. (9, 39, 71, 76, 78, 101, 115, 134, 145) "Where a number of facilities at distant 119 locations with similar operations or belonging to the same owner are involved, the extra effort and costs for physical examination of each site may not be justifiable. " (9) Similar facilities. A company with multiple facilities should send PEs from sister plants or corporate headquarters to assist in the review. (39) "We also question whether a PE should visit each and every site. Pennzoil builds its new company­ owned lube facilities to uniform corporate plans and makes the plans available to both franchised or other Pennzoil `featuring' quick lube operations. A PE should not be required to visit each site if he knows that the facility has been built to these specifications. Rather, an exemption should be granted for similarly situated and operated facilities, provided that the PE is familiar with the basic plan (i. e., the corporate quick lube facility design or the tank battery design." (71, 78, 145) NSPE opinion ­ ethics. A recent opinion of the National Society of Professional Engineers' Board of Ethical Review on a hypothetical case involving SPCC Plan certification concluded that it was appropriate for the PE to make a certification without having visited a given facility. (24) Off­ site engineers. Off­ site engineers often design a facility or structure without ever visiting the site. (192) Plan information veracity. The burden of proving the veracity of SPCC Plan information should be on the facility owner or operator. (9) Small facilities. We should not require a site visit for small entities. (82, 116, 134, 183) "...( D) ifferential requirements based on facility size may be valid." We should change the rule to excuse "small" facility site visits when there is "a determination that sufficient documentation of site characteristics is available for plan certification." (183) Temporary storage. "The requirement that a professional engineer examine each storage `facility' is similarly impractical for temporary (often mobile) storage." (60) Response: In general. EPA agrees that the rule should not necessarily require a site visit by a certifying PE, but we believe that a site visit should occur before the PE certifies the Plan. We have modified proposed §112.3( d)( ii) to reflect this position. The PE's agent may perform the visit. We agree that customary engineering practice allows someone under the PE's employ such as an engineering technician, technologist, graduate engineer, or other qualified person to prepare preliminary reports, studies, and evaluations after visiting the site. Then the PE could legitimately certify the Plan. Nevertheless, in all cases the PE must ensure that his certification represents an exercise of good engineering judgment. If that requires a personal site visit, the PE must visit the facility himself before certifying the Plan. 120 Particular cases. EPA agrees that a PE site visit requirement might be impractical at electrical substations, due to their large number. However, the PE need not go. One of his agents may go, and he may review the agent's work. We disagree with commenters who believe that a site visit is unnecessary at small facilities and temporary storage facilities. Site visits are necessary for those facilities to ensure Plan adequacy and to prevent discharges. EPA has interpreted the current rule language to contain a requirement that the PE examine the facility. Because of the uncertainty concerning the nature of this requirement, however, we will not require documentation of a site visit by a PE or his agent until after the effective date of this rule. We disagree that the rule should only require that the PE be familiar with the operation and design of the type of facility. We also disagree that merely because the PE has visited and examined one or more facilities of a particular type that no site visit is necessary. A facility may have individual characteristics that differ from those of its type in general, and a site visit by a PE or agent may be necessary to detect those characteristics and accommodate them in the Plan. Such individual characteristics include geographic conditions, possible flow paths, facility design and construction, type of containers, product stored, particular equipment, and the integrity of containment at the facility. Therefore, even if a PE has inspected many facilities of a particular type, that fact does not eliminate the need for a site visit at each facility. After the site visit by the PE or his agent, the PE will have to devise appropriate inspection and testing standards based on the facility's unique characteristics. Cost. We have imposed no additional burden on an owner or operator by clarifying the rule language. To mitigate costs, we allow the PE to send an agent to a site to conduct the site visit. That agent might be, for example, an engineering technician, technologist, graduate engineer, or other qualified person to prepare preliminary reports, studies, and evaluations after visiting the site. After review of the agent's work, the PE could legitimately certify the Plan. Editorial clarifications. "Registered Professional Engineer" becomes "licensed Professional Engineer." The first sentence of the paragraph was proposed as, "No SPCC Plan shall be effective to satisfy the requirements of this part unless it has been reviewed by a Registered Professional Engineer." We revised it to read, "A licensed Professional Engineer must review and certify a Plan for it to be effective to satisfy the requirements of this part." This revision is due to the fact that PEs are licensed by States. Inspection requirements. We agree that inspection of equipment is essential to Plan certification; training of personnel for response purposes is not required by the SPCC rule and the PE does not certify such training in his attestation. Plan information veracity. We agree. The owner or operator has a duty under §112. 3( d) to prepare and fully implement the Plan. Therefore, the facility owner or operator ultimately is responsible for providing the PE with accurate information. 121 Small facilities. We believe that a site visit is necessary for every facility, regardless of size, to prepare a Plan which will prevent a discharge as described in §112.1( b). 122 VI ­ G: PE Plan Certification ­ completion of testing procedures ­ §112.3( d) Comments: Support for proposal. "Proposed §112.3( d) adds responsibilities to the Professional Engineer (PE) in the preparation of SPCC Plans. The PE must certify `that required testing has been completed. ' Alyeska supports this requirement." (77) Inspection. "I think it would be better for the engineer to enumerate all the inspections and tests that have been completed, plus those that should be completed before the facility commences operations and those that should be undertaken periodically after it commences operations." (43) Tests required. "` Required testing' is not explained or defined and therefore unclear. East Ohio Gas recommends `required inspection'." (70) PE presence. We should clarify whether the PE must be present during testing. (58) Test completion. "Unfortunately much of the testing required under an SPCC Plan need not be performed before the Plan must be certified. Thus, the Engineer cannot attest to that Plan until all testing has been completed, which can take up to a year to complete. Instead of attesting to the `completion of required testing', we suggest that the engineer be allowed to attest to the presence of those written procedures, which require testing. By so doing, an engineer can certify the Plan before a facility begins operations." (33, 102) "This would appear to be an implementation activity, and should be the responsibility of the operator, not the engineer. In addition, unless the engineer is actually present at or performs the testing, his/ her ability to `attest' to such would be limited to a review of the results. Because these test results are to be maintained at the facility in any event, this requirement would make such an attestment redundant." (76, 121,146) Response: Support for proposal. We appreciate commenter support. Testing. EPA agrees that the PE is not responsible for certifying that all required testing has been completed. Rather, such responsibility belongs to the owner or operator of the facility. Testing may be ongoing long after the Plan is certified. The PE is responsible for certifying that the Plan is adequate and meets all regulatory requirements, including enumeration of all tests that have been completed, plus those that should be completed before the facility commences operations and those that should be undertaken periodically after it commences operations. Therefore, we are changing the proposed requirement to a requirement in which the PE attests that the procedures for required inspections and testing have been established, and the Plan is adequate for the facility. See the discussion of §112. 3( d) in today's preamble and immediately above in this document. 123 VI ­ H: Plan location at the facility ­ §112.3( e) Background: Under §112.3( e) of the current rule, an owner or operator must maintain the Plan at the facility if it is attended at least eight hours a day, or at the nearest field office if the facility is attended less than eight hours a day. In 1991, we proposed changing the eight­ hour threshold to four hours to ensure that a facility operating one shift per day has a Plan on site. Comments: Support for proposal. "We strongly agree with the proposed change to four hours, that a facility must be manned in order for a copy of the SPCC plan to be maintained at the facility. This will ensure that facilities that operate only one shift per day will have an SPCC plan on site. We have frequently been told by facilities that they will have to send us a copy of their plan from company headquarters when one is requested during a site inspection or spill response." (27, 42,101, L11). "Without advance notice." Would add the words "without advance notice" to end of proposed §112.3( d)( 2). "This change will emphasize the need to have the SPCC Plan fully implemented at all times, not just when there is notice of an impending inspection." (43) Opposition to proposal. Less than four hours; inconsistent requirements. "Under 40 CFR 111. 3( e)( 1), the SPCC Plan may maintain a copy of the Plan at the nearest field office if the facility is attended less than four hours a day. Under 40 CFR 112.3( e)( 2), however, the Plan must also be available for on­ site review during normal working hours. These are mutually inconsistent when applied to a facility operating less than four hours per day. ... It is apparent from the preamble, however, that EPA expects facilities to have their Plan available at all times at the facility. Thus, we see no rationale for having the Plan maintained at the nearest field office instead of at the facility itself. We would suggest, therefore, that the Plan be maintained only at the facility and not the nearest field office." (33). Editorial clarification. Suggests using the following text to clarify §112.3( e). "Owners or operators of facilities subject to this part must maintain a copy of the SPCC Plan for the facility, prepared pursuant to section 112.3( a), (b), (c), at the facility if the facility is normally attended at least four hours a day. If the facility is attended less than four hours a day, a copy of the plan must be maintained at the field office nearest to the facility. The owner or operator shall make the plan available to the Regional Administrator upon demand for on­ site inspection during normal working hours." (121) Location of Plan information. A "weather­ protected (laminated)" copy of the facility diagram and response actions should always be displayed in an obvious location near the main entry of the facility, and at "appropriate control centers." (76) 124 "Normal working hours." It is unclear whether "normal working hours" in proposed §112.3( e)( 2) refers to EPA working hours or the facility's working hours. (95, 101, 102) If "normal working hours" are our hours, then facilities staffed fewer hours than we are cannot meet this requirement. If "normal working hours" are the facility hours, then there is no problem with the requirement. (95, 102) Response personnel. We should modify the proposal to require keeping the Plan at the nearest office with operational responsibility for the facility or at the emergency response center to ensure that response personnel have access to the Plan. (125) State and local agencies. "LEPCs and SERCs would find it helpful to be aware of the availability of SPCC Plans and may wish to use them to augment their local and State response plans." (L11) Response: Support for proposal. We appreciate commenter support. Nearest field office, normal working hours. The term "nearest field office" in paragraph (e)( 1) means the office with operational responsibility for the facility, or the emergency response center for the facility, because those locations ensure accessibility for personnel who need to respond in case of a discharge. The term "normal working hours" in paragraph (e)( 2) refers to the working hours of the facility or the field office, not EPA. Location of Plan information. While an owner or operator may place a laminated copy of the Plan at a conspicuous place at the facility, there is no Federal requirement to do so. We do not require the owner or operator to keep the Plan in any particular place at the facility, merely "at the facility" when it is manned at least four hours a day. Plan availability. Today we have finalized the 1991 proposal that the Plan must be available at the facility if it is normally attended at least four hours per day, or at the nearest field office if it is not so attended. A Plan must always be available without advance notice, because an inspection might not be scheduled. You are not required to locate a Plan at an unattended facility because of the difficulty that might ensue when emergency personnel try to find the Plan. However, you may keep a Plan at an unattended facility. If you do not locate the Plan at the facility, you must locate it at the nearest field office. Less than four hours; Inconsistent requirements. We disagree that the rule provides mutually inconsistent requirements. If the facility is not attended at least four hours a day, the Plan must be maintained at the nearest field office, not the facility. State and local agencies. You are not required to file or locate a Plan with a State Emergency Response Commission or Local Emergency Planning Committee or other State or local agency because the distribution would unjustifiably increase the 125 information collection burden of the rule, and not all committees or agencies may want copies of SPCC Plans. Should a State wish to require filing of a Federal SPCC Plan with a State or local committee or agency, it may do so. No Federal requirement is necessary. VI ­ I: Extension of time ­ §112.3( f) Background: In 1991, we proposed to allow only new facilities to apply for extensions of time to comply with the requirements of part 112. The current rule allows any facility to apply for an extension, including existing fixed and mobile facilities. The rationale for limiting extension requests to new facilities was that existing fixed and mobile facilities have had since 1974 to comply with the rule. Comments: Amendments. "While the preamble discussion of this section mentions the requirement that plans be amended before any change is made and provides for extensions to be granted by the EPA Regional Administrator (RA) where immediate amendment of the SPCC plan is not practicable, no language to this effect could be found within the rule itself. ... Consequently, it is unclear if such requirements will apply or exactly how much time will be available to a facility to prepare an SPCC plan amendment." (71) Automatic extensions. "BHP has already stated its position that plans should not be required prior to beginning operations. If such a requirement is made, then extensions should be automatic upon the filing of a request for extension, so long as the request is made in appropriate form." (33, 42, 66, 110, 133, 167, L12) A request for an extension should be considered "routine." (155) Plan requirements. Criticizes the proposed requirement to submit the existing Plan with each extension request, because EPA's review of the Plan cannot practically be an element of the extension granting process. The language in paragraph (f)( 3) "would be better say that a facility's existing provisions remain in effect until they are superseded by changes proposed by the facility." (155) Response: Amendments. We have also added a provision for an extension of time to prepare and implement an amendment to the Plan, as well as an entire Plan. We believe that there may be cases in which an extension can be justified for a Plan amendment because the same extenuating circumstances may apply. Automatic extensions. Automatic extension requests are not justifiable because we have extended the time within which most facilities have to prepare and implement Plans. See §112.3( a), (b), and (c). Also, under the revised rule, you may request an extension for the preparation and implementation of any Plan, or amendment to any Plan. See §112.3( f). Plan requirements. We have broadened the scope of extension requests to any facility that can justify the request, because for every type of facility there may be cases in 126 which an extension can be justified. Existing fixed and mobile facilities may experience delays in construction or equipment delivery or may lack qualified personnel, and these circumstances may be beyond the control of, and without the fault of, the owner or operator. We also agree with the commenter that the submission of the entire Plan as a matter of course is unnecessary to evaluate each extension request. Therefore, we have amended the rule to provide that the Regional Administrator may request your Plan if he deems it appropriate. But we do not believe that he will always do so. It may be necessary under some circumstances. The Regional Administrator also retains discretion to request the Plan after on­ site review, or after certain discharges. See §112.4( a)( 9) and (d). We disagree with the commenter's proposed rewrite of the owner or operator's obligations while the request is pending because the better policy is to require compliance with the rest of the rule that is not affected by the extension request, rather than saying that the existing Plan continues in effect. 127 Category VII ­ Amendment to a Plan by the RA VII ­ A: Registered agents ­ §112.4( a) and (e) Background: Section 112.4 of the current rule describes: 1) the spill events for which an owner or operator must submit a Plan and other information to the Regional Administrator (RA) for review; 2) the information that must be submitted to the RA; and, 3) procedures for requiring amendments to the Plan. In 1991, we proposed several changes to §112.4. In §112.4( a), we proposed to require an owner or operator to provide the RA with the name and address of any registered agent when reporting a spill event, because a registered agent may have information that the RA needs. We also noted that the RA may need to contact the agent with further questions or send the reviewed Plan back to the agent. In §112.4( e), we proposed to continue requiring that the RA notify the facility owner or operator and the registered agent, if any, if the RA is proposing an amendment to the SPCC Plan. We withdrew the 1991 proposed revision of §112.4( a) in 1997, and substituted a new proposal without reference to a registered agent. Comments: Definition of "registered agent." "Since the term clearly has a specific meaning for EPA, it should either be added to 40 CFR 112.2 or specified within the preamble to the final rule. We would suggest EPA include this term in 40 CFR 112.2 since this individual has specific responsibilities under 40 CFR 112.4." (33) Notice to facility and agent. We should send the §112.4 notice directly to the affected facility and the registered agent. For a large railroad, it may take days for the affected facility to receive a notice given to a registered agent. (57) "The only way EPA can do this is by having the owner or operator notify EPA of the name and address of the registered agent. " (121) On­ site personnel. Because the registered agent would not know the facility SPCC Plan as well as on­ site personnel, the RA should contact the on­ site safety and environmental coordinator with questions concerning the Plan. (10) Response: We withdrew the 1991 proposal that the owner or operator supply the name and address of any registered agent to the RA because we do not always need the information, and may request it when we do. We will notify the registered agent of a corporation if we know who he is. The §112.4( e) notification requirement for registered agents now tracks the notification requirement for registered agents in §112.1( f). In §112.4( e) of the final rule, we have adopted a requirement that when the RA is requiring a Plan amendment, he must notify the owner or operator and any registered agent, if the registered agent is known. We also will notify the registered agent, if known, of the RA's determination in §112.1( f) that the facility owner or operator must prepare and implement a Plan. However, because we have not adopted the requirement that an owner or operator submit the 128 registered agent's name and address to the RA, we may not know of his registered agent. Likewise, we have no way of knowing who is the on­ site safety and environmental coordinator. Therefore, we cannot notify him. Definition of "registered agent." The concept of "agency" and "agent" is well­ known in the law. Therefore, no definition of "registered agent" is necessary in these rules. VII ­ B: Discharge reports to EPA ­ §112.4( a) Background: Section 112.4 of the current rule describes the discharges for which a facility owner or operator must submit the Plan and other information to the Regional Administrator (RA) for review, the information that must be submitted to the RA, and procedures for requiring amendments to the Plan. In the 1991 proposed rule, we proposed several changes to §112.4. In the 1991 proposed rule, we suggested several changes to §112.4. Proposed §112.4( a) provided that whenever an SPCC facility discharges more than 1,000 gallons of oil in a single spill event, as described in §112.1( b), in two spill events within a consecutive twelve month period, the owner or operator must submit to the RA certain information. In §112.4( a)( 10), we proposed to require that an owner or operator submit to the RA information on the nature and volume of oil spilled, in addition to the information currently required under §112.4( a) because this information would help the RA identify problem areas where additional regulatory emphasis may be needed. Section 112.4( a)( 13) would require the owner or operator to provide "such other information as the RA may reasonably require pertinent to the Plan or spill event." In 1997, we withdrew the 1991 proposal for §112.4( a) and substituted a new proposal. Comments: Support for proposal. We should require a report within a reasonable time period on the amount of product recovered during cleanup. (44) Amount spilled, proposed §112.4( a)( 10). Supports a requiring notification of "the nature and volume of oil spilled." (185, 193) Compliance with proposed requirement difficult. It may be impossible to retrieve oil after a spill to test its composition and quantify "exactly" what and how much was spilled. (92, 155, L12) Violating so imprecise a requirement would subject the violator unjustly to Clean Water Act penalty provisions. (L12) Date and year of initial facility operation. There is no purpose in providing the date and year of initial facility operation to the RA every time a spill occurs, and suggested we delete the requirement. (33) Discharges to soil. "The rule should be altered so that it is unambiguous in indicating that all spills of the threshold amounts will trigger the need to alter the SPCC Plan." A spill to soil, "poses a risk to surface water, even if the immediate impact is only on soil 129 or groundwater." Noting that SPCC Plans cover "only one 661 gallon above­ ground storage tank. Amendment of the SPCC Plan for such a facility will never be required even if the tank bursts every day, releasing all of its contents onto dry soil. Surely the intent of this regulation is not to deem such spills as routine." (43) Failure analysis. The term "failure analysis" in §112.4( a)( 9) is ambiguous and we should define it. (28, 58, 101) "Other" information, proposed §112.4( a)( 13). Section 112.4( a)( 13) is "overly broad and violates due process." (58) Threshold for §112.4( a). 100 gallons, single event. We should decrease the quantity of oil spilled during a spill event to trigger §112.4 applicability to 100 US gallons for a single event. A 100 gallon spill is a significant spill event, and we should not permit an owner or operator to defer amending a Plan "in the presence of smaller spill events." (43) 25 barrels single event, 50 barrels two events. The trigger should be a single spill greater than 25 barrels or two spills of 50 barrels or more within twelve months. Unless we set a "de minimis" amount for two spill events, an owner or operator would have to submit "a considerable amount of information" for all spills – even spills of "a few drips." (187) 100 barrels single event, 50 barrels two events. "API recommends that EPA change the requirement to one single spill event of more than 100 barrels or two spills of more than 50 barrels each in any consecutive twelve month period. There are numerous large oil fields in the coastal area which have an extensive network of flowlines, well jackets, and platforms. Even with all the precautions taken, it would not be unlikely for more than one spill of a de minimis size (e. g., less than one ounce of oil) to occur in one day. Under these proposed requirements, the O/ O would have to spend valuable resources filling out paperwork and reporting to EPA rather than trying to prevent reoccurrence." (67, 91, 173) Response: Support for proposal. We appreciate commenter support. We withdrew the proposal for §112.4( a) in the proposed 1997 rule and substituted new language for that section. Date and year of initial facility operation. In 1997, we withdrew the 1991 proposal for §112.4( a) and substituted a new proposal. We agree that it is an undue burden on an owner or operator to submit information on the date and year a covered facility began operations. That information is not always necessary in order to accurately assess the discharge or to require appropriate action. When it is necessary, the Regional 130 Administrator may request it. Therefore, we have eliminated the requirement to always submit such information after certain discharges. Discharges to soil. We have never proposed such a requirement for SPCC purposes. The purpose of the Act is to prevent discharges as described in §112.1( b), not discharges onto soil. A spill of oil onto soil may or may not ever become such a discharge. Failure analysis. "Failure analysis" means a study of the equipment or procedures to understand the reasons why such equipment or procedures did not function properly. The methods of such analysis should be determined according to industry standards. "Other" information, proposed §112.4( a)( 13). We disagree that proposed §112.4( a)( 13), §112.4( a)( 9) in the final rule, is overly broad or violates due process. EPA has authority under sections 308 and 311( m) of the Clean Water Act to require an owner or operator to provide information concerning requirements of the Act. Threshold for §112.4( a). We agree that a higher threshold of reporting discharges is justifiable because we believe that only larger discharges should trigger an EPA obligation to review a facility's prevention efforts. We also agree that a higher threshold should trigger a facility's obligation to submit information and possibly have to take further prevention measures. Therefore, we have changed the threshold for reporting after two discharges as described in §112.1( b). Under the revised rule, if you are the owner or operator of a facility subject to this part, you must only submit the required information when in any twelve month period there have been two discharges as described in §112.1( b), in each of which more than 42 U. S. gallons, or one barrel, has been discharged. The other reporting threshold of 1, 000 gallons in any a single discharge as described in §112.1( b) remains the same. We disagree that a sheen caused by a discharge as described in §112.1( b) over the threshold amount that disappears within 24 hours should not require submission of information. The discharge itself may indicate a serious problem at the facility which needs to be corrected. The discharge report may give us the information necessary to require specific correction measures. VII ­ C: General/ other ­ §112.4 VII­ C­ 1 Supplying discharge information to the States ­ §112.4( c) Background: Under §112.4( c) of the current rule, an owner or operator must submit to the State water pollution control agency or agencies, a copy of the information submitted to the RA under §112.4( a). In 1991, we proposed to require that an owner or operator submit the information to the State oil pollution control agency or agencies. Comments: Support for proposal. "The proposed change in section 112.4( c), which requires the operator to send a copy of the information provided the Regional 131 Administrator to the State agency in charge of oil pollution control rather than the agency in charge of water pollution, is helpful." "...( I) n Texas, as in other States, more than one agency has statutory jurisdiction over oil pollution control." (76, 99, 193) Authority. "USEPA does not have authority under the Clean Water Act to require an owner of a facility to file a copy of the sixty day report with the responsible state agency and therefore this requirement is unlawful. USEPA should remove this requirement." (58) Duplicative requirement. "Operator should not be required to forward this information to a state agency also. If EPA is to regulate the SPCC, this requirement is redundant and serves no purpose." (28, 101) "We disagree with the agency proposal that owners or operators be required to furnish the Regional Administrator with information. If the owner or operator provides a copy to the state agency in charge of oil pollution control, we believe this to be sufficient. The majority of states review the plan and submit written suggestions or improvements, etc. Submission of additional paperwork to the Regional Administrator is not consistent with the Paperwork Reduction Act as well as it would not serve any useful purpose." (82) Editorial comment. We should require sending the information to the appropriate "agency or agencies." (99) EPA guidance. We should tell each owner or operator which State agency should get §112.4( a) information. (76) Financial assistance. States cannot participate in reviewing §112.4( a) information without financial assistance. We should "consolidat( e) programs to eliminate duplicate agency involvement." (111) Required Plan amendments. We should specify that only the RA may require an Plan amendment – even if a State makes recommendations. We should clarify the regulatory text to avoid this ambiguity, adding that, "EPA may require implementation of State agency recommendations only if they are within the scope of the regulations. State agencies receiving incident reports should review the reports in the context of the incident at hand and use this information for its intended purpose of advising the RA on possible amendments to the Plan." (83) State water control agencies. The appropriate agency to receive information is the State water control agency, and that sending information to the oil pollution control agency would "most likely mislead an operator, the public, an officer of the court and/ or EPA itself." (L12) Response: Support for proposal. We appreciate the comment supporting our proposal to send §112.4( a) discharge information to the State oil pollution control agency or agencies. 132 Legal authority. We have ample legal authority to finalize this rule. A similar rule has been in effect since 1974. Section 311( j)( 1) of the CWA authorizes the Federal government (and EPA through delegation) to establish "procedures, methods, and equipment and other requirements for equipment to prevent discharges of oil...." Section 112.4( c) of this rule is a procedure to help prevent discharges that fall within the scope of that statutory provision. It enables States to learn of discharges reported to EPA and to make recommendations as to further procedures, methods, equipment, and other requirements that might prevent such discharges at the reporting facility. We can only implement State agency suggestions that are within the scope of our authority under section 311 of the CWA. In general. The commenter is correct that the SPCC program is a Federal program, but we believe that in working with the States, we can improve the Federal program through coordination with State oil pollution prevention programs. Therefore, we believe that the information provided to States is neither redundant nor unnecessary. Nor is the section misleading; it clearly states the obligation of the owner or operator. State agency review. We modified the 1991 proposal on the commenters' suggestion to include notice to any appropriate State agency in charge of oil pollution control activities, since there may be more than one such agency in some States and all may have need for the information. We do not list such agencies in the rule, as a commenter suggested, because the names and jurisdiction of the State agencies are subject to change. It is the reporter's obligation to learn which State agencies receive the discharge reports. Most States publish documents on an ongoing basis, similar to the Federal Register, which publicize relevant regulatory information. We do not provide State agencies funds to review these discharge reports due to budgetary constraints. While we assume that many States review these reports carefully, we cannot require them to do so. Thus, this action is not an unfunded mandate from the Federal government to the States. But if States do review the reports, they do so at their own expense. VII­ C­ 2 Amendment of Plans required by the RA ­ §112.4( d) Background: In §112.4( d), we proposed adding language giving the RA authority to approve a Plan after reviewing the materials submitted under §112.7( d). Comments: Appeals. Asks what the procedure is for appealing an RA's decision (on Plan approval) to the Administrator. (28, 101) PE role in RA­ required amendments. "...( A) ny `terms of amendment' made by the RA must be signed and sealed by an Agency or Agency retained professional engineer." When the RA requires a Plan amendment, "the certifying PE (has) no alternative but to certify the SPCC Plan or resign." In such cases, EPA must certify the change as meeting good engineering practice, and "the RA must be held accountable legally and 133 financially" when he mandates a change that "causes or results in an oil spill." (48, 63, 67, 72, 85, 110, 170, 173) Plan review and approval. Proposed §112.4( d) gives the RA "unlimited authority" to reject SPCC Plans. (28, 101) We should minimize or eliminate "any activities requiring agency approvals," given the "historical difficulty of getting dedicated resources to perform professional work related to these reviews." (111) Having the RA approve a Plan "puts an entirely new dimension in this process," and asked us to consider the approach. (121) "Plan review after a spill event by the EPA Regional Administrator is under the conditions identified in 40 CFR 112.4 are excessive and burdensome both to the EPA and regulated community. EPA should on a case by case basis review SPCC Plans after a spill event if the review is deemed necessary by the Regional Administrator or his/ her staff." (192) Time limit on review. "The current language of the referenced sentence could imply that the Regional Administrator must approve or request amendments to the SPCC's plans. In fact, the Regional Administrator does not have to take such affirmative action, unless he/ she so chooses. Plan approval is not necessary for the owner/ operator to continue operations of a facility. Therefore, once a plan is submitted, the owner/ operator should be given a certain specified waiting period for approval, after which he/ she can consider the submitted plan is adequate." (67) Response: Appeals. Because we have not adopted RA review and approval of Plans, no appeals process is necessary for a decision to reject a Plan. An appeals process exists for required Plan amendments. See §112.4( e). PE role in RA­ required amendments. A PE must certify any technical amendment to an SPCC Plan – irrespective of whether the owner or operator, or the RA, initiates the amendment process. When the RA decides a Plan amendment is necessary, it is the responsibility of the owner or operator to draft such amendment and implement it. The PE must certify that any amendment has been prepared in accordance with good engineering practice. Plan review and approval. We have deleted the provision that would have allowed RA approval of Plans. We have decided not to create a new class of SPCC Plans which require EPA approval, either Plans submitted following certain discharges as required by §112.4( a) or Plans with contingency plans, because we do not believe such approval is necessary in order to ensure effective Plans. Time limit on review. A time limit on RA review of a Plan is also moot because we withdrew the proposal which would have allowed RA review and approval of a Plan. VII­ C­ 3 Implementation of required amendments ­ §112.4( e) Comments: Implementation time for required amendments. 134 "Longer than 6 months." The rule "appears to contemplate a longer period than six months." We should change the language to read unless the RA specifies "a longer time" in place of "another date." (42) Six months may be an insufficient time to implement an amendment requiring new construction to the facility. (83, 143) One year (with construction). Six months is appropriate if the change is "purely operational," but that the implementation period should be "one year (after obtaining required permits) in a case where construction of facilities (is) required." (83) Extensions, reasons for. More than 6 months should be allowed for implementation if "the facility can show that the equipment, parts, etc., are not available to be installed in time, or if qualified contractors are not available to do the installation on time." (143) Who receives notice. We should "require that the RA provide notice to the facility operator, the facility improvement owner, and the facility landowner. The reason the expanded notice is desirable is that a major problem may be addressed by the facility operator and the EPA, without the knowledge and/ or consent of the facility improvements owner and the facility landowner." (47) Response: In 1991, we proposed no change in the six month timeline for implementing a required Plan amendment. We agree that in some cases that six months are not sufficient to implement an amendment. We have therefore amended the rule to allow an owner or operator to petition the RA for an extension to implement an amendment. See §112.3( f)( 1). Nonavailability of qualified personnel, or delays in construction or equipment delivery that are beyond the control of, and that are not the fault of the owner or operator, may justify an extension request. Who receives notice. The rule requires notice only to the owner or operator of the facility, and the registered agent, if any and if known. Notice from EPA to the facility improvements owner and landowner is unnecessary because these matters can and should be handled between the facility owner or operator and the owner or operator of the improvements or the landowner. VII­ C­ 4 Appeals of required amendments ­ §112.4( f) Comments: In §112.4( f), the word "decision" is ambiguous, and we should replace it with "ruling," a less ambiguous term. (70) Response: "Decision" is a commonly used legal term which in this context means the final determination of the RA when considering the appeal of a required amendment. 135 Category VIII: Amendment to a Plan by the owner or operator VIII ­ A: Plan amendment by an owner or operator ­ §112.5( a) Background: In §112.5( a) of the current rule, an owner or operator of a facility subject to §112.3( a), (b) or (c) must amend his Plan in accordance with §112.7 when there is a change in facility design, construction, operation, or maintenance which materially affects the facility's potential for the discharge of oil into or upon navigable waters or adjoining shorelines. An owner or operator must implement such amendment as soon as possible, but not later than six months after the change occurs. In 1991, we proposed in §112.5( a) to require an owner or operator to amend his Plan when making any material changes in facility design, construction, operation, or maintenance affecting the facility's potential for discharge of oil, unless the Regional Administrator grants an extension. In the preamble we noted that an owner or operator must amend the Plan before making any material changes in the specified categories. We also listed examples in the proposed rule of facility changes requiring Plan amendment. Comments: Support for proposal. "As with Section 112.3, we feel that this proposal has merit, because it requires plant personnel to evaluate the spill potential of their planned additions before they are built." (80, 181, L1) Accumulation of changes. "APS proposes that language be added to allow facilities that perform minor modifications on a regular basis, be allowed to `accumulate' those changes for a period of six months, then update the plan. In addition, APS suggest these `minor modifications' be defined as modifications that do not need additional containment or spill prevention systems to prevent oil from reaching `waters of the U. S. '" (74) Alternatives to amendment. Fractionization tank. "...( U) nless language were added to exclude fractionization tanks from the SPCC program, each time a frac tank is used or moved to a new location, a modification to the facility­ specific SPCC plan would be required per 112.5( a). Frac tanks are often used to store oil for short periods of time while maintenance or workover operations are underway. The use of frac tanks is of very short duration and does not necessarily increase the potential for a discharge." (167) Log book. Instead of amendment for standard facility activities, "BP proposes instead than an operations log book of such routine activities be maintained to document routine activities and what measures were taken to maintain the spill prevention and response integrity of the facility. Additionally, a facility status board showing the status of storage tanks, main control valves, dikes and dike drain valves, catchment basins, etc., could be posted in a prominent area to 136 keep all pertinent employees informed of the changing conditions at a facility." (96) Owner/ operator review ­ common repairs, etc. "...( M) ost plans can accommodate many changes without amending the Plan. This would be especially true of a facility that has site­ wide secondary containment. Operators should be allowed to document that they have reviewed such changes, and have either determined that an amendment to the Plan is not required, or have requested a review from the certifying PE. The PE should be allowed to document that he/ she has reviewed the planned changes, and has concluded an amendment is not necessary, that further study is required, or that an amendment is required." (76) "Pennzoil opposes any requirement that plans be amended prior to all changes to the tank structure. Pennzoil believes that flexibility, such as that provided in the current rule for amendments to SPCC plans, is essential to ensure that operators of facilities have the ability to make immediate modifications or repairs to oil piping or storage systems. ... To delay the modification until a plan can be revised and reviewed by a PE or to wait on the approval by the EPA RA of a requested extension of time could be detrimental." (71, 113) Material changes. "Adverse" effect. "The standard for operation and maintenance changes should be the same as that for design and construction changes– a change that would result in a material adverse effect to the potential of a facility to discharge oil." (35) Clarification needed. We should clarify what it means to materially affect a facility's potential to discharge oil. (96, 118, 164, 189) Examples of material changes. Support for EPA list. Support for proposed list of examples that may constitute a material change requiring Plan amendment. (102, 118, 170, L8) Opposition to EPA list. "A strict interpretation of the proposed rule would appear to require an amendment for any such change (and possibly a site visit by the certifying engineer). This is excessive. The people entrusted to the operation of such a facility should be able to evaluate most conditions and determine if an amendment is necessary." (76) We should narrow the examples of material changes. The list is too broad. (33, 34, 58, 75, 101, 125, 164, 165, 167, 173, L8, L12, 1155 (1993 commenter)). We should create an inclusive list of material changes. (189) Examples are not definitive for all facilities. "API believes that the wording in Section 112.5( a) should be changed to read `Examples of changes that may 137 require amendment to the Plan include, but... ' While API agrees with the requirement to report facility changes that materially affect a facility's potential to discharge oil, the examples of changes requiring amendment of the Plan would not, in most instances, materially affect a facility's oil discharge potential. In many facilities such as refineries, the examples of changes (in the proposed regulations), requiring SPCC Plan amendment and subsequent recertification by a PE are daily occurrences." (67, 86, 125) Change of product. "An amendment to the SPCC Plan should also be required when there is a change in the product stored within the tank. Such amendment should address the permeability of the secondary containment system, material compatibility, etc. for the product being stored." (111) "Changing a product in a tank or cleaning a tank should not be considered commissioning or decommissioning a tank." (143) Oil storage or transfer. We should clarify that only "systems and operations directly related to oil storage or transfer which may impact the environment" may require Plan amendment under §112.5( a). (62) Piping systems. "For instance, the replacement of a piping system is listed as a type of change that would require amending the Plan. Is this true when the piping replacement is made in accordance with the same industry standards as the original, serves the same function as the original, and is replaced in exactly the same location. What about adding a new piping run to an already existing run of 6 pipes carrying similar types of materials? BP suggests that neither of these changes are `substantial' but the proposed rule, as stated, could be interpreted otherwise." (96) Tanks over 5, 000 gallons. We should replace the word tanks with tanks over 5,000 gallons in our listing of examples. (L8) Changes which are not material. Commissioning tanks, etc. Commissioning, decommissioning, replacement, reconstruction, or movement of tanks (28, 37, 58, 66, 71, 96, 101, 113, 164, 165, L2, L15) Contact list. Non­ technical changes to the Plan (e. g., contact list, phone numbers, names, etc.) (72, 121, 190) Inspection documents. Non­ technical changes to the Plan, such as frequency of inspection and inspection documents. (72, 76, 165, L7) Piping systems. Reconstruction, replacement, or installation of piping systems. (28, 66, 96, 101, 113, 165, L2, L15). 138 Routine operation and maintenance. Revising standard operation or maintenance procedures at a facility (28, 35, 70, 101, 102, 165, 167, L6) Minor alterations or certain kinds of construction – such as replacing a pump or tank in­ kind or routine valve replacements – are not material changes. (155, 164) Revision of standard operation or maintenance procedures at a facility. We should clarify what constitutes a revision of standard operation or maintenance procedures at a facility. (L8) Time line for amendment implementation. Opposition to proposed time line. "Proposed section 112.5 would require an amendment to an SPCC Plan before there is a change in facility design, construction, operation, or maintenance of the facility that materially affects the facility's potential to discharge oil. IFTOA believes that the proposal is too broad. Numerous design changes are proposed as facilities are evaluated. Designs are made, modified, or discarded. Requiring an amendment every time a facility design is substantially changed will subject owners and operators to significant costs, wasted efforts and inefficiencies. Only when a material change has actually been implemented, such as completion of construction, should an amendment to the Plan be required." (54, 57, 68, 71, 75, 77, 103, 125, 155, 165, 167, 169, 170, 173, 191, L2, L15, L30) Alternative time frames. Start­ up of operations (103, 125, 155, 165, 170); after the completion of facility changes or modifications (54, 57, 75). After a design change, but before implementing that change (77); after installing new structures and equipment, but before operation (L2); and during the next triennial review (71). We should require owners or operators to amend the Plan when there is a material change in facility design, construction, operation, or maintenance. (75) For multi­ well drilling programs, we should require owners or operators to amend the Plan after completing a drilling program. (167) "Adequate time." We should allow owners or operators of existing facilities adequate time for Plan amendment. (71) 30 days. Thirty days after completing new construction, and make the extant Plan temporary during that period. (37) 90 days. We should allow owners or operators of exploration and production facilities and small gas processing operations 90 days to amend the Plan following any facility change. (114) 6 months. (67, 91, 110, 113, 167, 173,1155 (1993 commenter)). For implementing an amendment, we should allow owners or operators six months following facility changes. (35, 78, 101, 145) We should require implementing the Plan amendment within six months of a new facility's initial operations or 139 additions to an existing facility. The extant Plan should be temporary during that period. (134) We should allow owners or operators six months to amend the Plan following a change that does not increase the facility's oil discharge potential, but require a Plan amendment before a change that increases oil discharge potential. (190) Emergencies. The implementation time line could be detrimental in an emergency, because an owner or operator could not make immediate facility modifications or repairs without first amending the Plan. (71, 191) When amendment is necessary. Changes consistent with existing Plan. We should not require amendment of SPCC Plans for facility changes consistent with the existing Plan. (31, 86, 160, 1155 (1993 commenter)) Changes in discharge potential. We should require Plan amendment for replacing equipment only if the facility's oil discharge potential is materially changed. (31, 160) Decrease in discharge potential. We have no environmental justification for imposing amendment costs when owners or operators make changes that decrease a facility's discharge risk. (125) Increase in discharge potential. "APC recommends the wording in this section reflect an amendment is required, whenever a facility's potential for discharge of oil is changed or increased. The removal of equipment decreases the facility's potential and appropriate documentation should be placed in the Plan and be amended during the three year review process." (25, 35, 66, 71, 72, 98, 101, 118, 125, 167, L12) Changes "significantly impacting the environment." We should require owners or operators to amend the Plan only for changes that can significantly impact the environment. (L8) Changes warranting amendment. "We recommend that current SPCC Plans be allowed to remain intact as currently written until changes occur to existing oil storage facilities which warrant SPCC Plan amendments." (79) "Indicia of problems." Amendments should be made "when there are indicia of problems." (43) Response: Support for proposal. We appreciate commenter support. 140 Accumulation of changes. An owner or operator must amend the Plan when there is a material change at a facility. Therefore, he may not accumulate material changes for six months before amending the Plan. Alternatives to amendment. We disagree that owner/ operator review of facility changes is a substitute for Plan amendment. When no amendment is required because there is no material change, there is nothing to do. When amendment is required, it must be certified by a PE. We distinguish this review situation from the technological review mandated under §112.5( b). Under that provision, the owner or operator may certify that there has been a review and that he will not amend the Plan as a result. Log book. We agree that an owner or operator may document routine activities in an operations log book rather than require a Plan amendment. However, in the event of a material change at a facility, a log book entry is no substitute for Plan amendment. Material changes. We appreciate commenter support for our proposed examples of facility changes that constitute a material change. A material change is one that may either increase or decrease the potential for a discharge. We believe that an amendment is necessary when a facility change results in a decrease in the volume stored or a decrease in the potential for an oil spill because EPA needs this information to determine compliance with the rule. For example, the amount of secondary containment required depends on the storage capacity of a container. We agree with the commenter that the rule should be worded to indicate that the examples are for illustration only, because the items in the list may not always trigger amendments, and because the list is not exclusive. Only changes which materially affect operations trigger the amendment requirement. Ordinary maintenance or non­ material changes which do not affect the potential for the discharge of oil do not. We disagree that decommissioning of a container that results in permanent closure of that container is not a material amendment. Decommissioning a container could materially decrease the potential for a discharge and require Plan amendment, unless such decommissioning brings the facility below the regulatory threshold, making the preparation and implementation of a Plan no longer a requirement. We also believe that the oversight of a Professional Engineer is necessary to ensure that the container is in fact properly closed. We agree that replacement of tanks, containers, piping, or equipment may not be a material change if the replacements are identical in quality, capacity, and number. However, a replacement of one tank with more than one identical tank resulting in greater storage capacity is a material change because the storage capacity of the facility, and its consequent discharge potential, have increased. The addition of a new piping run to an already existing run of 6 pipes carrying similar types of materials may likewise be a material change because it may reflect a change in storage capacity or may affect the integrity of the secondary containment system. 141 Changes of product. We have added to the list of examples, on a commenter's suggestion, "changes of product." We added "changes of product" because such change may materially affect facility operations and therefore be a material change. An example of a change of product that would be a material change would be a change from storage of asphalt to storage of gasoline. Storage of gasoline instead of asphalt presents an increased fire and explosion hazard. A switch from storage of gasoline to storage of asphalt might result in increased stress on the container leading to its failure. Changes of product involving different grades of gasoline might not be a material change and thus not require amendment of the Plan if the differing grades of gasoline do not substantially change the conditions of storage and potential for discharge. A change in service may also be a material change if it affects the potential for a discharge. A "change in service" is a change from previous operating conditions involving different properties of the stored product such as specific gravity or corrosivity and/ or different service conditions of temperature and/ or pressure. Therefore, we have amended the rule to add "or service" after the phrase "change of product." Revision of standard operation or maintenance procedures at a facility. A revision of a standard operation or maintenance procedure is a change in such operation or procedure that may materially affect the facility's potential for discharge. If it does, it must be the subject of an amendment to the Plan. Time line for amendment implementation. We agree with commenters that we should not require Plan amendment before material changes are made. Therefore, we have revised the proposed rule to provide a maximum of six months for Plan amendment, and a maximum of six more months for amendment implementation. This is the current standard. We note that §112.3( f) allows the RA to authorize an extension of time to prepare and implement an amendment under certain circumstances. When amendment is necessary. We agree with the commenter who suggested that we maintain the current standard for amendments, i. e., when there is a change that materially affects the facility's potential to discharge oil. This position accords with our stance on when Plans should be prepared and implemented. See §112.3. The other suggested standards too narrowly limit the changes which would trigger Plan amendment. We believe that an amendment is necessary when a facility change results in a decrease in the volume stored or a decrease in the potential for an oil spill because EPA needs this information to determine compliance with the rule. For example, the amount of secondary containment required depends on the storage capacity of a container. Decreases might also affect the way a facility plans emergency response measures and training procedures. A lesser capacity might require different response measures than a larger capacity. The training of employees might be affected because the operation and maintenance of the facility might be affected by a lesser storage capacity. 142 Likewise, a standard requiring amendment "when there are indicia of problems" is too vague and leaves problems unaddressed which may result in a discharge as described in §112.1( b). A standard requiring an amendment only when the change would cause the spill potential to exceed the Plan's capabilities (because day­ to­ day changes do not affect the worst case spill) would have the effect of leaving no documentation of amendments which might affect discharges which do not reach the standard of "worst case spill." While we encourage facilities to incorporate new procedures into Plans which would help to prevent discharges, amendments are still necessary when material changes are made to document those new procedures, and thus facilitate the enforcement of the rule's requirements. We disagree that a small facility should be exempt from making amendments for material changes. Amendments may be necessary at large or small facilities alike to prevent discharges after material changes. Tanks over 5, 000 gallons. We decline to apply the §112.5( a) material change requirement only to tanks or containers over 5, 000 gallons. A small container may be the source of a discharge. Therefore, preventive measures are necessary for such containers, including Plan amendments. VIII ­ B: Periodic review of plans ­ §112.5( b) Background: Under §112.5( b) of the current rule, the owner or operator of a facility subject to §112.3( a), (b), or (c) must complete a review and evaluation of his SPCC Plan at least once every three years from the date his facility becomes subject to part 112. He must amend the SPCC Plan within six months of the review to include more effective prevention and control technology if such technology will significantly reduce the likelihood of a spill event from the facility, and if such technology has been fieldproven at the time of the review. In the 1991 proposal, we requested comments on whether a facility owner or operator should affix a signed and dated statement to the SPCC Plan indicating that the triennial review has taken place and whether the Plan requires amendment. We did not propose a change in rule text in 1991, but in 1997 we proposed to require the owner or operator to certify completion of the review. We also proposed in 1997 to change the three­ year review cycle to a five­ year review cycle. We address the comments received on the 1997 proposal in the Response to Comments document for the 1997 proposal. Comments: Support for proposal. "Without this requirement, we feel that many companies would claim to have reviewed their plan when they had not." (10, 27, 62, 74, 95, L17). Opposition to proposal. "The requirement would be extremely costly and unnecessary. (28, 31, 37, 54, 83, 86, 101, 143, 160) If a Plan is submitted and approved, we should require no further changes. (28, 101) 143 Case­ by­ case basis. "The requirement proposed at subsection (b) should be deleted. If necessary, they could be applied on a case by case basis to facilities determined by the Agency to present a high risk of catastrophic failure. In no case should they be applied to all facilities subject to SPCC Plan requirements." (31, 86, 160) Lack of oversight. We cited no evidence of an increased number of spills from SPCC­ regulated facilities due to a lack of managerial oversight. There is no evidence that more managerial oversight would improve the quality and effectiveness of an SPCC Plan. (31, 34) This provision would be redundant and would result in an unnecessary paperwork increase. (25, 155, 190, 192) Owner/ operator discretion. "This rule should remain flexible and be implemented at the discretion of the facility owner/ operator. If EPA believes that a technology should be adopted by industry, it should announce it in the Federal Register, hold a public hearing, and consider all the arguments for and against imposing the requirement." (143) PE input. "Accordingly, IFTOA recommends that amendments to the SPCC Plan be made following triennial review and evaluation if the Registered PE, after his review of the new technology and a cost benefit analysis, informs the company that changes should be made. Thus, good engineering practices rather than `speculation' about new technology will be the underlying basis for any amendment." (54) Production facilities. "Applying such a requirement to typical oil and gas production operations could cause premature abandonment of valuable reserves by imposing potentially high investment requirements on facilities which by nature produce a decreasing revenue stream over time. Given the low risk from the typical oil and gas production operation, such a requirement is unjustified." (31, 86) Field­ proven technology. We should clarify the term field­ proven technology. (35, 27) Who performs the review. "Professional Engineers, not facility owners and operators, should complete the three­ year SPCC Plan review and evaluation to determine if the facility is in compliance with relative industry standards as well as federal and state rules and regulations. Most owners, if left to their own discretion, will not voluntarily say or realize that their facility is not in compliance. This puts a greater burden on the regulating community to verify facility compliance." (111) Documentation of review. We should require owners or operators to affix a signed and dated statement to the Plan stating that the review has taken place, and indicating whether an amendment to the Plan is necessary. (121) 144 Response: Support for proposal. We appreciate commenter support. We note that we do not routinely require an owner or operator to submit the Plan nor do we approve Plans. We decline to grant the owner or operator discretion to decide whether or not to conduct the review. This provision is important for all regulated facilities, large and small, because modern technology is dynamic, and a responsible owner or operator should periodically assess whether the latest field­ proven technological advances could decrease the facility's oil spill potential. Documentation of review. We agree that we should require an owner or operator to affix a signed and dated statement to the Plan stating that the review has taken place, and indicating whether an amendment to the Plan is necessary. See the 1997 Response to Comments Document for further discussion of this issue. Time line for amendment implementation. We agree with commenters (see comments on proposed §112.5( a)) that the preparation and implementation of Plan amendments require more time than proposed. The same rationale applies to the preparation and implementation of amendments required due to five­ year reviews. Therefore, we will require adherence to the time lines laid down in §112.5( b) for amendments. Currently, §112.5( b) requires that Plan amendments be prepared within six months. It is silent as to timelines for implementation. Therefore, we have revised the rule to clarify that amendments must be implemented as soon as possible, but within the next six months. This is the current standard for implementation of certain other amendments. See, for example, §§ 112.3( a) and 112.4( e). We note that §112.3( f) allows you to request an extension of time to prepare and implement an amendment. Field­ proven technology. Field­ proven technology means that the technology has been validated in a setting typical of everyday use. VIII ­ C: PE certification of technical amendments ­ §112.5( c) Background: Under §112.5( c) of the current rule, a Professional Engineer (PE) must certify any amendment to an SPCC Plan in accordance with §112.3( d). We proposed to modify this provision in 1991 to require that a PE must certify all amendments to the Plan except for the contact list required by §112.7( a)( 3)( ix). Comments: Support for proposal. Allowing changes to the contact list without PE certification makes sense and results in cost savings for facilities. (23, 27, 88, 103) PE certification. The §112.5( c) requirement to certify every amendment by a PE poses too great a cost, and the benefits do not justify the costs. (28, 69, 101, 165, L15) Increase in discharge potential. We should require PE certification only for changes that increase a facility's potential to discharge oil. (95, 102, 167, L12) 145 Changes "affecting" discharge potential. We should require PE certification only for changes that affect a facility's potential to discharge oil. (33, 48, 67, 173, 175, L7) "Modify" physical characteristics. We should require PE certification only for facility changes that modify the physical characteristics and engineering features described in the Plan. (115) Substantive changes, three­ year review. We should require Plan recertification only if the owner or operator makes substantive changes to the Plan or is engaged in the Plan three­ year review. (75) PE certification ­ technical amendments. Adopting the proposed requirement would result in less frequent Plan revision. (62) Decommissioning tanks, minor modifications to piping systems, and changes in operations or maintenance procedures at a facility should not require Plan recertification. (113, 165, L15) "Section 112.5( c) should be revised to allow some facility changes, including those changes requiring Plan amendments [see 112.5( a)] without the requirement to recertify the Plan." (91, 133, 182) PE Certification ­ Plan or amendment. We should clarify whether a PE must recertify the Plan or simply certify Plan amendments. (76) Alternate certification suggested. We should revise §112.5( c) to allow either a geologist or hydrologist with a degree and five years experience; an engineer with a degree and five years experience; or a registered PE to certify Plan amendments. (70) Response: Support for proposal. We appreciate commenter support. However, we have reduced the regulatory and information collection burden by permitting a five­ year review interval, with the same technological conditions. We have also adopted the requirement proposed in 1997 that the owner or operator certify completion of the review. PE certification. It is the responsibility of the owner or operator to document completion of review, but completion of review and Plan amendment are two different processes. PE certification is not necessary unless the Plan is amended. PE certification ­ technical amendments. We believe that PE certification is necessary for any technical amendment that requires the application of good engineering practice. We believe that the value of such certification justifies the cost, in that good engineering practice is essential to help prevent discharges. Therefore, we have amended the rule to require PE certification for technical changes only. Non­ technical changes not requiring the exercise of good engineering practice do not require PE certification. Such non­ technical changes include but are not limited to items as: changes to the contact list; more stringent requirements for stormwater discharges to comply with NPDES rules; phone numbers; product changes if the new product is 146 compatible with conditions in the existing tank and secondary containment; and, any other changes which do not materially affect the facility's potential to discharge oil. If the owner or operator is not sure whether the change is technical or non­ technical, he should have it certified. PE Certification ­ Plan or amendment. The PE must only certify any amendments made when the owner or operator amends the Plan pursuant to §112.5( c), not the entire Plan. Alternate certification suggested. We disagree that anyone other than a PE should certify a Plan or an amendment. See the discussion under section IV. D and under section V (relating to §112.3( d)) of today's preamble, and section VI. C of this document. PE certification ­ standard for amendment. We disagree that we should require PE certification only for changes that would increase a facility's potential to discharge oil. We believe that an amendment is necessary when a facility change results in a decrease in the volume stored or a decrease in the potential for an oil spill because EPA needs this information to determine compliance with the rule. For example, the amount of secondary containment required depends on the storage capacity of a container. 147 Category IX: Civil Penalties ­ §112.6 (Rescinded) Background: Section 112.6 of the original SPCC rule set out the civil penalties associated with violating various part 112 provisions. In 1991, we proposed a more extensive list of provisions, the violation of which would subject an owner or operator to these penalties. Comments: Federal agencies are subject to civil penalties under the CWA. (42) Criminal penalties associated with negligent violations are unreasonable because one drop of oil is a harmful quantity. (62) The civil penalties stated in §112.6 are excessive – especially for small oil facilities. The penalty amounts might exceed a small operator's net worth. (28, 101) The terms substantial harm and sensitive (environments) are vague, and owners or operators may face law suits as a consequence of various interpretations of these terms. (149) The amendment is unnecessary because current penalty provisions already encourage adequate containment and spill prevention measures. (192) Response: We have not adopted the proposal that would expand the list of part 112 provisions and the civil penalties associated with violating those provisions because we rescinded §112.6 in 1996. We rescinded §112.6 because that penalty provision no longer accurately reflected the penalties provided for under section 311( b) of the Act, as amended by OPA. March 11, 1996, 61 FR 9646. EPA disagrees that Federal agencies are subject to penalties or fines under the CWA because the Federal government is not a "person" under sections 311( a)( 7) or 502 of the CWA. Only "persons" (including owners or operators and persons in charge) are subject to such penalties. Therefore, although Federal agencies must comply with requirements of a CWA section 311 rule in accordance with CWA section 313, they are not subject to civil or criminal penalties or fines. See U. S. Department of Energy v. Ohio, 503 U. S. 607, 618 (1992) (because the CWA does not define "person" to include the United States, the civil penalty provisions are not applicable.) 148 Category X: General substantive requirements ­ §112.7 X ­ A: Reorganization of the regulation ­ §112.7( a) and (a)( 1) (See also section V 14 Background: In 1991, we proposed to separate §112.7 into five sections (§§ 112.7, 112. 8, 112. 9, 112. 10, and 112. 11), based on facility type to promote ease in using and understanding the regulation. Proposed §112.7 provided general requirements for preparing SPCC Plans. The new sections addressed detailed Plan requirements for onshore facilities (excluding production facilities) (§ 112. 8); onshore production facilities (§ 112. 9); onshore oil drilling and workover facilities (§ 112. 10); and offshore oil drilling, production, and workover facilities (§ 112. 11). In reorganizing part 112 into sections, we intended no substantive change. In 1995, Congress enacted Public Law 104­ 55, the Edible Oil Regulatory Reform Act (EORRA). That statute mandates that most Federal agencies differentiate between and establish separate classes for various types of oils. In response to EORRA, we have divided part 112 by subparts for the various classes of oil listed in that Act. Subpart A consists of an applicability section, definitions, and general requirements for all facilities. Subpart B is for petroleum oils and non­ petroleum oils, except for animal fats and vegetable oils. Subpart C is for animal fats and oils and greases, and fish and marine mammal oils; and for oils of vegetable origin, including oils from seeds, nuts, fruits, and kernels. Subpart D is for response requirements. Sequence of Plan. In 1991, in §112.7( a)( 1), we reproposed the requirement in the current §112.7 introductory paragraph that the Plan must follow the sequence outlined in §112. 7, and include a discussion of how the facility conforms with the requirements listed in the rule. We modified the 1991 proposal in 1997 to allow alternate formats. See the preamble to today's rule and the 1997 Comment Response Document. In the final rule, the reference to sequence §112.7( a)( 1) was relocated to the introductory paragraph of §112.7( a). Current §112.7( a) ­ pre­ 1974 spills. Because the information was no longer relevant, in 1991, we proposed deletion of §112.7( a), which required a description of certain discharges to navigable waters or adjoining shorelines that occurred prior to the effective date of the rule in 1974. Comments: Current §112.7( a) ­ pre­ 1974 spills. "This proposal to eliminate the inventory requirement is appropriate since records of pre­ 1973 discharges often do not exist, and even if these records are available, they provide no useful environmental protection benefit to current mining operations or to EPA and create a serious administrative and investigative burden." (25, 35, 114) 149 Management approval of Plan. We were unclear when we proposed in §112.7( a)( 1) that "the Plan shall have the full approval of management at a level with authority to commit the necessary resources to fully implement the Plan." We should clarify whether we require any documentation for this approval and whether there are any limitations on who we consider "management." (115) Sequence of Plan. §112.7( a)( 3). The sequence should be as outlined in §112.7( a)( 3). It "would be most helpful to have the outline clearly stated by a paragraph immediately following Section 112.7( a)( 1)." (121, L33) Clarification needed. "The proposed rule is written in such a way that is unclear as to the proper format of the plan. ... We recommend that a guidance document containing examples of acceptable SPCC Plans be made available before or at the time of promulgation of the final rule." (79) No set sequence. "The Section 112.7( a)( 1) requirement that all Plans follow a specific `sequence' should be deleted. To require that all Plans to follow a predesignated sequence which may or may not be the most appropriate or useful for the facility personnel that must carry out the Plan is not in the best interest of protecting navigable waters. The Plan developers should be allowed the freedom to organize the Plan to suit the facility needs relative to SPCC requirements and to incorporate elements required by other regulations for the development of such emergency prevention and response plans. During an actual emergency, a consolidated Plan greatly enhances the effectiveness of the response." (67, 95, 102, 175) Recommendation instead. We should change the requirement to a recommendation, because a requirement provides no pollution prevention benefit. (95) Support for reorganization. Support for our decision to separate §112.7 into five sections based on facility type. EPA recognized the differences in facility design and sought to provide the regulated community with greater certainty about its legal obligations. (27, 53, L4) Opposition to reorganization. We would increase reporting requirements; replace an existing, satisfactory compliance program with one that asserts additional command and control authority; expand regulatory jurisdiction; and increase compliance costs to industry and society, while providing no incremental environmental protection benefit. (35) We are creating an unnecessary burden by restructuring the regulation. (16, 79) Response: We have reorganized the rule text, placing §§ 112.8 through 112.11 into Subpart B. We have changed the section numbers of the provisions, but have not thereby imposed new requirements, nor expanded our jurisdiction or authority. 150 Current §112.7( a) ­ pre­ 1974 spills. In 1991, we proposed to delete §112.7( a), which required a description of certain discharges to navigable waters or adjoining shorelines which occurred prior to the effective date of the rule in 1974, because that information was no longer relevant. 56 FR 54620. We received several comments supporting the proposed deletion of this provision, and have deleted it. Management approval of Plan. The owner or operator of the facility, or a person at a management level with sufficient authority to commit the necessary resources, must implement the Plan. That person may vary from facility to facility, therefore we cannot specify a certain title. Documentation of this authority is shown by signature on the Plan. Sequence of Plan. In the 1997 proposal, we withdrew the1991 proposal that would have required a Plan to follow the sequence outlined in §112.7. See the Response to Comments Document for the 1997 proposal for the comments and responses to that proposal. X ­ B: Deviations ­ §112.7( a)( 2) Background: In 1991, we proposed to amend §112.7( a)( 2) to permit the use of methods not expressly called for in proposed §112.7( c) and §§ 112.8 through 112.11, as long as these practices provided environmental protection equivalent to part 112 provisions. In the 1991 proposal, we said that we would retain our discretion to determine that an alternative method did not provide equivalent protection. Comments: Support for proposal. This provision would encourage development of innovative spill prevention and control measures. (72, 164, 190, L29) Opposition to proposal. Electrical equipment. Requirements other than the secondary containment and integrity testing requirements ­­ may be impracticable for electrical equipment, including the proposed §112.8 drainage requirements and the requirement to provide detailed site plans, flow paths, and failure analyses. (125) RA oversight. "Apparent" equivalency. References the provision in proposed §112.8( b)( 3) that "drainage systems from undiked areas `shall' flow into ponds, lagoons, or catchment basins" as "one example of a requirement that does not lend itself to comparison with an `equivalent' alternative." Equivalency may not be apparent in some instances from the physical structure of the alternative measure. "...( I) n practice it will be impossible to prove equivalency to the satisfaction of EPA enforcement officials." (125, 146, 170, 189, L27) 151 EPA evaluation. "An alternative is to require that Plans containing such a technical waiver be reviewed by US EPA in order to determine if such a method is applicable to the use intended." Whether an alternate measure provides "equivalent alternate protection" depends on the facility and the location within the facility. (76) Inspectors and equivalency. The "check­ lists of requirements" that inspectors often carry do not include "equivalent environmental protection." Because we did not provide guidance on what constitutes an equivalent measure, the inspector may be "unfamiliar with the unique operational characteristics of utility equipment." (125) Mathemetical equivalency. We should clarify that §112.7( a)( 2) does not require mathematical equivalency of every requirement, but rather, the "achievement of substantially the same level of overall protection from the risk of discharge at the facility as the specific requirement seeks to achieve." It would be impossible to prove equivalency to the satisfaction of inspectors. (125, 170) No RA oversight. Would delete provision allowing RA to overrule alternative measures selected under this section. (121) Response: Support for proposal. We appreciate commenter support. Applicability. We generally agree with the commenter that an owner or operator should have flexibility to substitute alternate measures providing equivalent environmental protection in place of express requirements. Therefore, we have expanded the proposal to allow deviations from the requirements in §112.7( g), (h)( 2) and (3), or (i), as well as subparts B, and C, except for the listed secondary containment provisions in §112.7 and subparts B and C. The proposed rule already included possible deviations for any of the requirements listed in §§ 112.7( c), 112.8, 112.9, 112.10, and 112.11. We have expanded this possibility of deviation to include the new subparts we have added for various classes of oils. We take this step because we believe that the application of good engineering practice requires the flexibility to use alternative measures when such measures offer equivalent environmental protection. This provision may be especially important in differentiating between requirements for facilities storing, processing, or otherwise using various types of oil. A deviation may be used whenever an owner or operator can explain his reasons for nonconformance, and provide equivalent environmental protection. Possible rationales for a deviation include when the owner or operator can show that the particular requirement is inappropriate for the facility because of good engineering practice considerations or other reasons, and that he can achieve equivalent environmental protection in an alternate manner. For example, a requirement that may be essential for a facility storing gasoline may be inappropriate for a facility storing asphalt; or, the owner or operator may be able to implement equivalent environmental protection through an alternate technology. An owner or operator may consider cost as one of the 152 factors in deciding whether to deviate from a particular requirement, but the alternate provided must achieve environmental protection equivalent to the required measure. The owner or operator must ensure that the design of any alternate device used as a deviation is adequate for the facility, and that the alternate device is adequately maintained. In all cases, the owner or operator must explain in the Plan his reason for nonconformance. We wish to be clear that we do not intend this deviation provision to be used as a means to avoid compliance with the rule or simply as an excuse for not meeting requirements the owner or operator believes are too costly. The alternate measure chosen must represent good engineering practice and must achieve environmental protection equivalent to the rule requirement. Technical deviations, like other substantive technical portions of the Plan requiring the application of engineering judgment, are subject to PE certification. In the preamble to the 1991 proposal (at 56 FR 54614), we noted that "... aboveground storage tanks without secondary containment pose a particularly significant threat to the environment. The Phase One modifications would retain the current requirement for facility owners or operators who are unable to provide certain structures or equipment for oil spill prevention, including secondary containment, to prepare facilityspecific oil spill contingency plans in lieu of the prevention systems." In keeping with this position, we have deleted the proposed deviation in §112.7( a)( 2) for the secondary containment requirements in §§ 112.7( c) and (h)( 1); and for proposed §§ 112.8( c)( 2), 112.8( c)( 11), 112.9( c)( 2), 112.10( c); as well as for the new sections which are the counterparts of the proposed sections, i. e., §§ 112.12( c)( 2), 112.12( c)( 11), 112.13( c)( 2), and 112.14( c), because a more appropriate deviation provision already exists in §112. 7( d). Section 112. 7( d) contains the measures which a facility owner or operator must undertake when the secondary containment required by §112.7( c) or (h)( 1), or the secondary containment provisions in the rule found at §§ 112.8( c)( 2), 112.8( c)( 11), 112.9( c)( 2), 112.10( c), 112.12( c)( 2), 112.12( c)( 11), 112.13( c)( 2), and 112.14( c), are not practicable. Those measures are expressly tailored to address the lack of secondary containment at a facility. They include requirements to: explain why secondary containment is not practicable; conduct periodic integrity testing of bulk storage containers; conduct periodic integrity and leak testing of valves and piping; provide in the Plan a contingency plan following the provisions of 40 CFR part 109; and, provide a written commitment of manpower, equipment, and materials to expeditiously control and remove any quantity of oil discharged that may be harmful. Therefore, when an owner or operator seeks to deviate from secondary containment requirements, §112.7( d) will be the applicable "deviation" provision, not §112.7( a)( 2). Deviation submission. We agree with the commenter that submission of a deviation to the Regional Administrator is not necessary and have deleted the proposed requirement. We take this step because we believe that the requirement for good engineering practice and current inspection and reporting procedures (for example, §112. 4( a)), followed by the possibility of required amendments, are adequate to review Plans and to detect the flaws in them. Upon submission of required information, or upon on­ site review of a Plan, if the RA decides that any portion of a Plan is 153 inadequate, he may require an amendment. See §112.4( d). If you disagree with his determination regarding an amendment, you may appeal. See §112.4( e). RA oversight. Once an RA becomes aware of a facility's SPCC Plan as a result on an on­ site inspection or the submission of required information, he is to follow the principles of good engineering practice and not overrule a deviation unless it is clear that such deviation fails to afford equivalent environmental protection. This does not mean that the deviation must achieve "mathematical equivalency," as one commenter pointed out. But it does mean equivalent protection of the environment. We encourage innovative techniques, but such techniques must also protect the environment. We also believe that in general PEs will seek to protect themselves from liability by only certifying measures that do provide equivalent environmental protection. But the RA must still retain the authority to require amendments for deviations, as he can with other parts of the Plan certified by a PE. Not covered under the deviation provision. Deviations under §112.7( a)( 2) are not allowed for the general and specific secondary containment provisions listed above because §112.7( d) contains the necessary requirements when you find that secondary containment is not practicable. We have amended both this paragraph and §112.7( d) to clarify this. Instead, the contingency planning and other requirements in §112.7( d) apply. Deviations are also not available for the general recordkeeping and training provisions in §112.7, as these requirements are meant to apply to all facilities, or for the provisions of §112.7( f) and (j). We already provide flexibility in the manner of record keeping by allowing the use of ordinary and customary business records. Training and a discussion of compliance with more stringent State rules are essential for all facilities. Therefore, we do not allow deviations for these measures. X ­ C: Plan information ­ §112.7( a) and (b) Background: In 1991, in §112.7( a)( 1), we reproposed the requirement in the current §112.7 introductory paragraph that the Plan must follow the sequence outlined in §112. 7, and include a discussion of how the facility conforms with the requirements listed in the rule. In proposed §112.7( a)( 3)( i)­( ix), we clarified which facility characteristics which the owner or operator must describe in the Plan, including unit­ by­ unit storage capacity; type and quantity of oil stored; estimates of quantity of oils potentially discharged; possible spill pathways; spill prevention measures; spill control measures; spill countermeasures; provisions for disposal of recovered materials; and a contact list with appropriate phone numbers. We also proposed a requirement for a facility diagram on which the location and contents of all tanks would be marked. Under proposed §112.7( a)( 4), an owner or operator would have to provide documentation in the Plan that would enable a person reporting a spill to provide spillspecific information, including the exact address and phone number of the facility; the spill date and time; the type of material spilled; estimates of the total quantity spilled; 154 estimates of the quantity spilled into navigable water; the spill's source; a description of the affected medium; the spill's cause; any damages or injuries caused by the spill; actions being used to stop, remove, and mitigate the effects of the discharge; whether an evacuation may be needed; and the names of individuals and/ or organizations who had also been contacted. Current §112.7( b) requires that, where experience indicates a reasonable potential for equipment failure (e. g., tank overflow, rupture, or leakage), the owner or operator must include in the Plan a prediction of the direction, rate of flow, and total quantity of oil that could be discharged from the facility as a result of each major type of failure. In §112.7( b), we proposed to clarify that the requirements for discharge prediction were not contingent on the past spill experience of a facility. X­ C­ 1 Facility physical description and diagram ­ §112.7( a)( 3) Background: In 1991, in §112.7( a)( 3), we proposed to require that a Plan include a facility diagram on which are marked the location and contents of all tanks. We also proposed to require that an owner or operator address in the Plan the essential facility characteristics listed in §112.7( a)( 3)( i)­( ix). Comments: Support for proposal. "GM supports the proposed SPCC plan requirements detailing physical attribute of the facility, such as capacity, types of oil, pathways, etc." (76, 90) Opposition to proposal. "Overall, for large facilities such as refineries, the amount of detail required in 112.7( a)( 3) is unreasonable, very resource intensive to compile and too voluminous for Agency staff to assimilate or evaluate. API believes the level of detail required will add little value to the Plan for large facilities such as refineries." (67) Contents of tank. "However, including the contents of the tanks on the diagram is not practical. First, many of the tanks are used for different products depending on seasonal fluctuations and other market demands; and by other proposed changes the plan would require amendment for each such change. Secondly, if there are more than just a handful of tanks, it is difficult for a new visitor to a facility to identify which tank contains products which are potentially explosive, reactive, corrosive, or otherwise dangerous to emergency spill response." (76, 92) Containers not storing oil. Asks whether "exempt ASTs which do not contain oil" should be marked on a facility diagram. "It would seem consistent with the reasoning for showing tanks exempt due to their UST status (i. e., emergency response crews would be able to identify oil containing tanks from those with other materials.)" (62) Risk. Suggests "Alternative wording, such as `... indicate the type of product (crude oil, gasoline, acid, etc.) or other information as necessary to expediently evaluate the relative hazards presented' would be more appropriate. In addition, 155 requiring recommending methods to readily identify such tanks by on­ tank displays would be prudent as well." (76) Facility diagram ­ De minimis containers. "112.7( a)( 3) Requirement for plan to describe location and contents of all tanks will be unwieldy if even very small containers must be included. Request that de minimis level exemptions be established." (62, 66, 125, 179, 184) 660 gallons. "API believes tanks with less than capacity of 660 gallons should not be included on the facility diagram. These tanks are excluded from current SPCC regulations and mandating inclusion of such tanks would make the facility diagram less useful due to increased clutter. The cost of preparing the diagram would also increase substantially. Furthermore such tanks are often portable, making inclusion on a facility diagram impractical." (67) Facility diagram, exempt materials. Asks whether exempt USTs which do not contain oil should be marked on facility diagrams. "It would seem consistent with the reasoning for showing tanks exempt due to their UST status (i. e., emergency response crews would be able to identify oil containing tanks from those with other materials.)" (62) "Subjecting otherwise exempt facilities to the requirements for ... facility diagrams (112.7( a)( 3)) is unreasonable considering the negligible risk posed by facilities `not reasonably expected to discharge oil'." (167) Facility diagram ­ Transfer stations, connecting pipes, and USTs. We should require an owner or operator to include in the Plan a diagram that shows transfer stations and connecting pipes. (111) General description of characteristics. Approved substances. "... BP proposes that facility storage tank diagrams be required to show the location of tanks and products approved to be stored in that type of storage tank (ie. cone roof, internal or external floating roof, heated, etc.). A list of possible substances (gasolines, diesel fuels, residual oils, crude oils, etc.) approved to be stored in each tank or type of tanks would be indicated on the facility diagram or elsewhere in the SPCC Plan. The log book and facility status board would then provide information on the current contents of each tank." (96) Facility based information. We should require that the owner or operator address §112.7( a)( 3) information "on a facility basis." "This addition would clarify the detail needed for the Plan and make it consistent with the type of information required in the Section 112.1( e), notification requirements. Since storage capacity and type and quantity stored in each tank is not required in the notification requirements, it should not be required in this Plan." (67) 156 Numbered list. Would revise §112.7( a)( 3) to read: "The complete plan must describe the facility's physical plant and include a facility diagram, which must indicate the location of all tanks which shall be numbered, and it must be accompanied by a separate list of all the numbered tanks. Those tanks in oil service must have their contents listed after the tank number on the tank list. A facility shall maintain an up­ to­ date list of tank contents as part of theSPCC plan and shall furnish it to EPA upon request. If tanks have been removed or added to a facility, the facility must submit a new tank diagram and a list of numbered tanks which states the contents of those in oil service." (143) Potential to contaminate navigable water. "EPA should provide additional clarification that the required facility diagram is intended to be of a level of detail to support the evaluation of the potential for an oil spill to reach navigable water and that a block diagram of only those facility components directly related to this risk (e. g., non­ process equipment) is the minimum performance standard." (L12) Physical description of facility. "Descriptions of the physical plant at a facility are provided under many existing state regulatory schemes. Once again, the Agency is urged to develop a better approach to working with State regulatory authorities instead of redoubling the burden on the regulated community." (42) Response requirements. We should separate response plan requirements from spill prevention plan requirements, removing all response plan requirements from §§ 112. 7( a)( 3)( viii) and (ix), (a)( 4), and (a)( 5) and grouping them in another section containing only response plan requirements. (121) Small facilities. Small production facilities. "OOGA believes that the facility diagram requirement will be extremely burdensome to the small entity with no real environmental benefit, and particularly on the crude oil production facility owner who would be obligated to construct one for each of its facilities. Once again, for the reasons set forth above, OOGA requests that USEPA exempt these small facilities from the exception." (28, 31, 58, 70, 86) Such a requirement would add two hours to the facility review process. (70) This requirement would be burdensome and of limited value because many facilities have only one tank. We should allow more time for an owner or operator to comply or require him to create a facility diagram by the end of the three­ year review process. (101) Specific Plan requirements. We should require the owner or operator to address the requirements, where applicable, listed in §§ 112.8, 112.9, 112.10, and 112.11 in the Plan. (121) Response: Support for proposal. We appreciate the commenter support. 157 General description of characteristics. The following characteristics must be described on a per container basis: the storage capacity of the container, type of oil in each container, and secondary containment for each container. The other characteristics may be described on a facility basis. Based on site inspections and professional judgment, we disagree that these requirements are too resource intensive. The major new requirement in §112.7( a)( 3) is the facility diagram. Based on site inspections and professional judgment, we estimate unit costs for compliance with this section to be $33 for a small facility, $39 for a medium facility, and $5 for a large facility. Large facilities are assumed to already have a diagram that may be attached to the SPCC Plan. The other items mentioned in §112.7( a)( 3) ­ storage capacity of each container, prevention measures, discharge controls, countermeasures, disposal methods, and the contact list ­ are already required under the current rule or required by good engineering practice. As described in the Information Collection Request for this rule, the cost of Plan preparation includes these items, e. g., field investigations to understand the facility design and to predict flow paths and potential harm, regulatory review, and spill prevention and control practices. Providing information on a container­ specific basis helps the facility to prioritize inspections and maintenance of containers based on characteristics such as age, capacity, or location. It also helps inspectors to prioritize inspections of higher­ risk containers at a facility. Container­ specific information helps an inspector verify the capacity calculation to determine whether a Plan is needed; and, helps to formulate contingency planning if such planning is necessary. Facility diagram. The facility diagram is important because it is used for effective prevention, planning, management (for example, inspections), and response considerations and therefore we believe that it must be part of the Plan. The diagram will help the facility and emergency response personnel to plan for emergencies. For example, the identification of the type of oil in each container may help such personnel determine the risks when conducting a response action. Some oils present a higher risk of fire and explosion than other than less flammable oils. Inspectors and personnel new to the facility need to know the location of all containers subject to the rule. The facility diagram may also help first responders to determine the pathway of the flow of discharged oil. If responders know possible pathways, they may be able to take measures to control the flow of oil. Such control may avert damage to sensitive environmental areas; may protect drinking water sources; and may help responders to prevent discharges to other conduits leading to a treatment facility or navigable waters. Diagrams may assist Federal, State, or facility personnel to avoid certain hazards and to respond differently to others. The facility diagram is necessary for all facilities, large or small, because the rationale is the same for both. While some States may require a diagram, others do not. SPCC is a Federal program specifying minimum requirements, which the States may supplement with their own more stringent requirements. We note that State plans may be used as SPCC Plans if they meet all Federal requirements, thus avoiding any 158 duplication of effort if the State facility diagram meets the requirements of the Federal one. Facility diagram ­ container contents. The facility diagram must include all fixed (i. e., not mobile or portable) containers storing 55 gallons or more of oil and must include information marking the contents of those containers. If you store mobile containers in a certain area, you must mark that area on the diagram. You may mark the contents of each container either on the diagram of the facility, or on a separate sheet or log if those contents change on a frequent basis. Marking containers makes for more effective prevention, planning, management, and response. We disagree that a list of products approved for storage in the container is sufficient for emergency response. While a document outlining what materials might be stored in a container is useful, it does not say what is actually in it at a particular time. For example, a responder may take one type of emergency measure for one type of oil, and another measure for another type. As noted above, oils differ in their risk of fire and explosion. Gasoline is highly flammable and volatile. It presents the risk of fire and inhalation of vapors when discharged. On the other hand, motor oil is not highly flammable, and there is no inhalation of vapors hazard associated with its discharge. In an emergency, the responder may not have container content information unless it is clearly marked on a diagram, log, or sheet. For emergency response purposes, we also encourage, but do not require you to mark on the facility diagram containers that store CWA hazardous substances and to label the contents of those containers. When the contents of an oil container change, this may or may not be a material change. See the discussion on §112.5( a). Facility diagram ­ De minimis containers. We have established a de minimis container size of less than 55 gallons. You do not have to include containers less than 55 gallons on the facility diagram. Facility diagram ­ Transfer stations, connecting pipes, and USTs. We agree that all facility transfer stations and connecting pipes that handle oil must be included in the diagram, and have amended the rule to that effect. This inclusion will help facilitate response by informing responders of the location of this equipment. The location of all containers and connecting pipes that store oil (other than de minimis containers) must be marked, including USTs and other containers not subject to SPCC rules which are present at SPCC facilities. Again, this is necessary to facilitate response by informing responders of the location of these containers. Physical description of facility. We appreciate the commenter's support. In the final rule, we have changed the requirement for a description of the "physical plant" of the facility to a description of the "physical layout" of the facility. If the owner or operator has provided that information in a State plan, he may use the same information in his Federal SPCC Plan if the State requirement is cross­ referenced to the Federal requirement. 159 Response requirements. We generally agree that response plan requirements should be separate from spill prevention plan requirements. However, the information required in §112. 7( a) facilitates response to an emergency and is necessary for all facilities. Because a facility with a response plan already documents the required information, we have therefore have exempted any such facility from documenting certain information required for SPCC facilities in §112. 7( a). See, for example, revised §112. 7( a)( 3), (4), and (5). We disagree that there is no need for §112.7( d). The Minerals Management Service (MMS) is not responsible for all offshore oil production facilities. Offshore facilities in the inland area fall under EPA jurisdiction. (See EO 12777.) Specific Plan requirements. We agree that an owner or operator should address specific requirements applicable to a facility. Section 112. 7( a)( 1) requires a facility owner or operator to discuss how a facility conforms with part 112 requirements. Furthermore, the introductions to §§ 112.8, 112.9, 112.10, 112.11, 112.12, 112.13, 112.14, and 112.15 reference the obligation to address both general and specific requirements for the facility. X­ C­ 2 Unit­ by­ unit storage capacity ­ §112.7( a)( 3)( i) Background: In 1991, in §112.7( a)( 3)( i), we proposed to require that an owner or operator address unit­ by­ unit storage capacity in the Plan. Comments: Minimum size. We should specify a minimum size for units that owners or operators must include in the Plan. (62, 66, 79, 125, 164, 170, 184) Small sizes. Opposition to proposal. Requiring owners or operators to itemize small units would be unnecessarily costly and burdensome with little to no additional environmental benefit. (62, 66, 125, 164, 170) Alternative sizes suggested. 660 gallons or less. Tanks containing greater than 660 gallons. (92,125, 164) 10,000 gallons ­ electrical equipment. Electrical equipment containing greater than 10,000 gallons of oil or dielectric fluid. (125, 170, 184) If small pieces of equipment at electrical substations "catastrophically" fail, they do not fail synergistically and create other failures. We should not focus on controlling spills from small pieces of equipment that are only a few gallons and are quickly cleaned up. (164) Mobile containers. According to the proposed requirement, an owner or operator would have to revise the Plan every time a drum of oil was received or a piece of oil containing manufacturing equipment was moved within the facility. (79) 160 "Unit." We did not define the term unit, and we should clarify whether we meant tank­ by­ tank storage capacity. (28, 31, 101, 165, L15) Response: Minimum size. Under §112.1( d)( 5) of the final rule, part 112 does not apply to aboveground or completely buried containers with an oil storage capacity of less than 55 gallons. Therefore, the owner or operator need not include in the Plan containers smaller than 55 gallons. If the containers move frequently, the owner or operator may mark the location of those containers on a separate sheet or log. Movement of containers may or may not be a material change in the Plan requiring amendment, depending on whether the move increases or decreases the risk of a discharge. "Unit." For clarity, we have changed the term unit­ by­ unit storage capacity to type of oil in each container and its storage capacity. X­ C­ 3 Type and quantity of oil stored ­ proposed §112.7( a)( 3)( ii) Background: In 1991, in §112.7( a)( 3)( ii), we proposed to require an owner or operator to address in the Plan the type and quantity of oil stored at the facility. Comment: "Because the way a tank is used changes often and the adequacy of response to an accidental discharge does not hinge on the type of oil stored, Conoco cannot support this requirement." (75) Response: We have eliminated proposed §112.7( a)( 3)( ii) in the final rule because it repeats information requested in revised §112.7( a)( 3)( i) We disagree with the assertion that the responder's knowledge of the type of oil stored does not affect the adequacy of response. Responders use different emergency measures for different types of oil. X­ C­ 4 Estimates of quantities of oil potentially discharged ­ proposed §112.7( a)( 3)( iii) Background: In 1991, in §112.7( a)( 3)( iii), we proposed a requirement that an owner or operator address estimates of the quantity of oils that could be discharged. Comments: See section XI­ C– 12 of this document for the comments on this paragraph. Response: We have eliminated proposed §112.7( a)( 3)( iii) in the final rule because it repeats information sought in §112.7( b) regarding "a prediction of the direction, rate of flow, and total quantity of oil that could be discharged." We address substantive comments under the discussion of that paragraph. 161 X­ C­ 5 Spill pathways ­ proposed §112.7( a)( 3)( iv) Background: In 1991, in §112.7( a)( 3)( iv), we proposed to require an owner or operator to address possible spill pathways in the Plan. Comments: See section XI­ C­ 12 of this document for comments on this issue. Response: We have eliminated proposed §112.7( a)( 3)( iv) in the final rule because it repeats information sought in final §112.7( b), which asks for "a prediction of the direction, rate of flow, and total quantity of oil that could be discharged" as a result of each type of major equipment failure. We address the substantive comments under the discussion of that provision. X­ C­ 6 Spill prevention measures ­ §112.7( a)( 3)( ii) Background: In 1991, in §112.7( a)( 3)( v), redesignated in the final rule as §112.7( a)( 3)( ii), we proposed to require the owner or operator to address in the Plan spill prevention measures, including procedures for routine handling of products. Comment: We should replace §112.7( a)( 3)( v) with the words secondary containment. (121) Response: We adopted the term discharge prevention measures in the final rule rather than secondary containment, because the term encompasses both secondary containment and other discharge prevention measures. X­ C­ 7 Spill controls and secondary containment ­ §112.7( a)( 3)( iii) Background: In 1991, in §112.7( a)( 3)( vi), redesignated in the final rule as §112. 7( a)( 3)( iii), we proposed to require that the owner or operator address in the Plan spill controls such as secondary containment around tanks and other structures, equipment, and procedures for the control of a discharge. Comments: Drainage controls. We should replace this provision with the requirement that owners or operators address "other drainage control features, and the equipment (pipes, pumps, meters, etc.) which they protect." (121) NASA standards. The National Aeronautics and Space Administration's (NASA's) Scientific and Technical Information (STI) Program standards should meet this spill control requirement. (140) Underground piping, completely buried tanks. We should clarify that underground piping does not need secondary containment. (57) Response: Drainage controls. We agree with the commenter. In the final rule, we have revised the requirement to refer to discharge or drainage controls to clarify that 162 drainage systems or diversionary ponds could serve as alternative means of secondary containment. NASA standards. An owner or operator may follow STI standards for spill control if they meet part 112 requirements, but must discuss in the Plan how those standards meet these requirements. Underground piping, completely buried tanks. Underground piping is subject to the secondary containment requirements in §112.7( c). Whether you install secondary containment around such piping involves issues of practicability and the reasonable possibility of a discharge as described in §112. 1( b). The same rationale applies to completely buried storage tanks. X­ C­ 8 Spill countermeasures ­ §112.7( a)( 3)( iv) Background: In 1991, in §112.7( a)( 3)( vii) (redesignated as §112.7( a)( 3)( iv) in the final rule), we proposed to require the owner or operator to address in the Plan spill countermeasures for spill discovery, response, and clean­ up (facility's capability and those that might be required of a contractor). Comments: Contingency planning. "For clarity, EPA should consider trying to consolidate the contingency planning requirements located in these paragraphs. For example, 112.7( b) required a prediction of total quantity of oil that could be released and prediction of the direction of flow. This same information is already required under 112. 7( a)( 3)( iii) and (iv). In 112. 7( a)( 3)( vii) spill countermeasures for spill discovery, response, and cleanup are required. It appears that this same type of information is again required under 112.7( d)( 1) where a contingency plan including a description of response plans, personnel needs, and methods of mechanical containment are required." (16) Editorial suggestion. We should change this provision to require the owner or operator to address "prevention, control, or countermeasure features, other than secondary containment and drainage control, and the equipment which they protect" in the Plan. (121) Response: Contingency planning. We disagree that these provisions are duplicative. Each section requires discrete information. Section 112.7( a)( 3)( iv) requires information concerning a facility's and a contractor's capabilities for discharge discovery, response, and cleanup. We also note that §112.7( b) requires information concerning the potential consequences of equipment failure. Section 112.7( d)( 1) requires a contingency plan following the provisions of part 109, which includes coordination requirements with governmental oil spill response organizations. Editorial suggestion. We disagree with the suggestion. We believe the language we proposed, as revised, better captures the information we are seeking. Our revised language refers to discovery, response, and cleanup, which are features that are 163 absent from the commenter's suggestion, and for which a discussion in the Plan is necessary in order to be prepared for any discharges. X­ C­ 9 Disposal of recovered materials ­ §112.7( a)( 3)( iv) Background: In 1991, in §112.7( a)( 3)( viii) (redesignated as §112.7( a)( 3)( v) in the final rule), we proposed to require the owner or operator to address the disposal of recovered materials in the Plan. Comments: Support for proposal. "Conoco supports the requirement that the plan address applicable state laws, federal laws, and disposal options. However, it would be neither feasible nor useful to discuss particular alternatives." (75) Opposition to proposal. Certification. "Detailed provisions for disposal of recovered materials is unreasonable for manufacturing facilities which may have small quantities of many types of oil and petroleum materials. A certification that disposal will be in compliance with all federal and state regulations should be sufficient for `small size' facilities." (62) Regulatory duplication. "APC believes that the disposal of material recovered are regulated by State law and/ or RCRA and a discussion of this subject in the Plan is inappropriate." (58, 66, 125, 164, 170, L12) Specific options. "The proposed regulations seem to require that commitments be made for specific disposal options for wastes which have not been generated. The federal and state solid waste disposal options and requirements are complex and changing. We suggest that disposal commitments in the SPCC Plan be limited to a statement which commits to disposal of wastes in accordance with applicable regulatory requirements." (70, 75, 92, 125, L12) Unnecessary. "SPCC Plans prepared under the current regulation do not require this information. Furthermore, such practices may already be included in other Plans such as Best Management Practices Plans or RCRA Contingency Plans." (79) The issue of waste disposal does not belong in a document designed to address preventing oil contamination to navigable waters. (164) We should clarify why we have included this new provision. The disposal of oil spill clean­ up waste does not impede spill containment or clean­ up activities. (L12) Authority. We do not have the authority under the CWA to request this information. (28, 58) 164 Bioremediation. "On­ site bioremediation would be a much more economical and practical means of cleaning up an oil spill to achieve an equivalent environmental benefit." (101, 113) Costs. The requirement to address disposal of recovered materials in the Plan may have major cost implications. (31, 165, L15) Recycling. "...( W) e also believe the SPCC regulation should encourage recycling of spilled oil to the extent possible." (61) Response: Support for proposal. We appreciate the commenter support. Applicability, necessity for proposal. This provision applies to all facilities, including mobile facilities, because proper disposal of recovered materials helps prevent a discharge as described in §112.1( b) by ensuring that the materials are managed in an environmentally sound manner. Proper disposal also assists response efforts. If a facility lacks adequate resources to dispose of recovered oil and oil­ contaminated material during a response, it limits how much and how quickly oil and oil­ contaminated material is recovered, thereby increasing the risk and damage to the environment. A commitment to dispose of materials in accordance with applicable laws is by itself insufficient, because we need evidence of actual methods employed. Onshore or offshore mobile drilling and workover rigs. We disagree that either onshore or offshore mobile drilling and workover rigs should be exempted from this requirement because the information necessary to this requirement is not always site specific, and may be included in a general plan for a mobile facility. Authority. Under section 311( j)( 1)( C) of the CWA, we have authority to establish procedures, methods, equipment, and other requirements to prevent and contain oil discharges. Collecting information on disposal of recovered materials is a procedure or method to help prevent or contain discharges. Bioremediation. We disagree that this paragraph would preclude bioremediation efforts, as some commenters suggested. Bioremediation may be a method of proper disposal. Cost. Because it does nothing more than require that you explain the method of disposal of recovered materials, we also disagree that this provision is too costly. Also, we assume that good engineering practice will in many cases include a discussion of such disposal already. By describing those methods in the Plan, you help ensure that the facility has done the appropriate planning to be able to dispose of recovered materials, should a discharge occur. Editorial suggestion. We disagree that we should replace the proposed language with language requiring that the owner or operator dispose of materials in accordance with 165 proper State and Federal regulations. Our proposed language captures both State and Federal regulations and is more succinct. Recycling. We support the recycling of spilled oil to the extent possible, rather than its disposal. For purposes of this rule, disposal of recovered materials includes recycling of those materials. Regulatory duplication. The paragraph merely requires that you discuss the methods employed to dispose of recovered materials; it does not require that materials recovered be "disposed" of in any particular manner nor is it an independent requirement to properly dispose of materials. Thus, there is no infringement on or duplication of any other State or Federal program or regulatory authority. X­ C­ 10 Contact list ­ §112.7( a)( 3)( vi) Background: In 1991, in §112.7( a)( 3)( ix), redesignated in the final rule as §112.7( a)( 3)( vi), we proposed to require that an owner or operator include in the Plan a contact list and phone numbers for the facility response coordinator, the National Response Center (NRC), clean­ up contractors, fire departments, the LEPC, the SERC, and downstream water suppliers. Comments: Support for proposal. "The inclusion of an `Emergency Contact List' is appropriate. Kerr­ McGee E& P/ USO (United States Onshore) SPCC Plans include such a proposed Emergency Contact List." (27, 90, 114, L11) Agreement for response. We should change our proposal to require that the owner or operator identify the following: "Each cleanup contractor that has agreed in writing... to respond to a spill at the facility, the period of time that the cleanup contractor's commitment is valid, an enumeration of the types of spills to which each cleanup contractor is licensed to remediate, and the listing of the license number( s) and license expiration date( s) for each cleanup contractor." Otherwise, many owners or operators will not check whether the clean­ up contractor list is current. (47) Applicability. Mobile facilities. Because they move from site­ to­ site, we should exempt an owner or operator of an onshore and offshore mobile drilling and workover rigs from our §112.7( a)( 3)( vii)­( ix) requirements to list spill countermeasures, contact lists, and material disposal methods in the Plan. (128) Authority. We do not have the authority under the CWA to require the owner or operator to list State emergency response phone numbers in this provision of the Plan. Such a requirement is within the State's exclusive authority. (58) Downstream water suppliers. 166 Affected by a discharge. "This requirement should be modified to make clear that only downstream water suppliers who might reasonably be affected by a discharge must be notified." (28, 31, 92, 101, 125, 165, 170, 189, L02, L15) Alternatives to notice. "In addition, the facility operator should be given the option of notifying the local entities such as the local emergency planning committee and leave the notification of individual water suppliers to that body." (62, 66, 92, 125, 170, 189) Basis for estimates. We should base the applicability of §112. 7( a)( 3)( ix) on estimates of quantities of oils potentially discharged. (28) Case­ by­ case determination. An owner or operator should assess each spill, and determine case­ by­ case which downstream water suppliers to notify. (66) Central registry of suppliers. "Where does an operator obtain a list of water suppliers? Water suppliers should be located in a central registry to help operators discover who they are." (28, 31, 165, L15) Distance. "There must be a downstream distance limit placed on this based on estimates of quantities of oil potentially discharged. This should not include private wells." (28, 31, 92, 101) "Endless" list. A list of downstream water suppliers could be endless. The LEPC or the U. S. Coast Guard should determine which downstream water suppliers to alert. (164) Suppliers of record. Only "water suppliers of record" should be notified. (31, 165, L15) Unnecessary requirement. This requirement is unnecessary and costly for Appalachian producers. (101) Local and State emergency response authorities already collect all information regarding downstream water suppliers pursuant to the Federal Emergency Planning and Community Right­ to­ Know Act, and regulations promulgated thereto. This paragraph should be deleted and removed to a response plan section because the information called for requires response information. (62, 189) Whom should be notified. Agencies notified of accidental discharges. In keeping with the SPCC Program's focus on accidental discharge prevention and response, we should require that the contact list include only those State and Federal agencies that must be notified of an accidental oil discharge. (75) 167 LEPC, SERC, USCG. We should require owners or operators to include only the LEPC, SERC, and the U. S. Coast Guard in the contact list. (164) Response: Support for proposal. We appreciate commenter support. Agreement for response. In response to a comment, we have amended the rule to require that the cleanup contractor listed must be the one with whom the facility has an agreement for response that ensures the availability of the necessary personnel and equipment within appropriate response times. An agreement to respond may include a contract or some less formal relationship with a cleanup contractor. No formal written agreement to respond is required by the SPCC rule, but if you do have one, you must discuss it in the Plan. Applicability, mobile facilities. We disagree that either onshore or offshore mobile drilling and workover rigs should be exempted from this requirement because the information necessary to this requirement is not always site specific, and may be included in a general plan for a mobile facility. Authority. We have ample authority to ask for information concerning emergency contacts under the CWA because it is relevant to the statute's prevention, preparedness, and response purposes. CWA section 311( m)( 2). Furthermore, it is an appropriate question for all facilities, including mobile facilities, because it is necessary to prepare for discharges and to aid in prompt cleanup when they occur. Having a Plan which contains a contact list of response organizations is a procedure and method to contain a discharge of oil as specified in CWA section 311( j)( 1)( C). Downstream water suppliers. We have deleted the reference to "downstream water suppliers" (i. e., intakes for drinking and other waters) because facilities may have no way to identify such suppliers. We agree with commenters that identifying such suppliers is more a function of State and local emergency response agencies. We note, however, that facilities that must prepare response plans under §112.20 must discuss in those plans the vulnerability of water intakes (drinking, cooling, or other). Response section. We disagree that the information should be placed in a response section, because most SPCC facilities are not required to have response plans, and the information is necessary to prepare for response to an emergency. Whom should be notified. We have eliminated references to specific State and local agencies in the event of discharges in favor of a reference to "all appropriate State and local agencies." "Appropriate" means those State and local agencies that must be contacted due to Federal or State requirements, or pursuant to good engineering practice. You may not always be required to notify fire departments, local emergency planning committees (LEPCs), and State emergency response commissions (SERCs), nor as an engineering practice do they always need to receive direct notice from the facility in the event of a discharge as described in §112. 1( b). At times they might, but they might also receive notice from other sources, such as the National Response 168 Center. Other State and local agencies might also need notice from you. We have added the word "Federal" to the list of all appropriate contact agencies because there are times when you must notify EPA of certain discharges. See §112.4( a). There might also be requirements under other Federal statutes, other than the CWA, for notice in such emergencies. X­ C­ 11 Spill reporting requirements ­ §112.7( a)( 4) Background: In 1991, in §112.7( a)( 4), we proposed to require that the owner or operator include in the Plan documentation enabling a person reporting a spill to provide essential information. Comments: Opposition to proposal, necessity for it. We should not expand the Plan content requirements if we seek to simplify the Plan. Provisions such as the spill reporting requirements in (a)( 4) "frustrate any attempts to clarify the regulatory framework." (42) We should: "Delete and remove to response plan." (117, 121) Documentation. Rather than requiring an owner or operator to provide documentation in the Plan, we should require that "the information addressed in the Plan shall enable a person" to report a spill in accordance with the rest of the paragraph's requirements. By requiring documentation, we would decrease the Plan's usefulness as an emergency response tool. (75) Delayed reporting. We should not require documentation that may be unavailable to the person initially reporting the spill, or highly speculative. If we require this information from the spill reporter, notification from the facility may be less prompt. (16) Future event. "It is not possible to provide `documentation in the Plan' which will enable a person reporting a spill to provide information on the spill date, time, type of materials spilled, estimation of the total quantity spilled, etc., if the spill has not happened. Suggest that this section be qualified to indicate that a form for collecting such information be included either in the plan, or for `small size facilities' in the HAZWOPER reporting matrix." (62) Inapplicable information. Some of the information we would require may not apply to a wide variety of facilities. (167, 175) Unavailable information. "Not all of the information listed for the purposes of reporting a release will be `available' to the person reporting the discharge or `applicable' to the discharge incident or to the facility at which the release took place." (67, 85, 117, 167, 175) Editorial suggestion. We should replace the word spill with the word discharge or release. A spill does not necessarily result in a discharge or a release to navigable 169 waters, and we should not require reporting when a spill or leak has been fully contained. (39) Facility address and phone number. Many facilities have no address or telephone. We should require that an owner or operator provide the facility location rather than the address and phone number. (28, 67, 70, 128, 133, 167, L12) Response plan. "This is part of response. Delete and remove to response plan." (121) State requirements. The spill reporting provision duplicates State regulations. (167) Response: Opposition to proposal, necessity for it. We disagree that we should eliminate a requirement to provide information and procedures concerning the cause of a discharge or its effects. Such information and procedures in the Plan is necessary to enable a person reporting a discharge to accurately describe information concerning that occurrence to the proper persons in an emergency. Documentation. We agree with commenters that the word "documentation" is inappropriate because it refers to a past event. Accordingly, as suggested by commenters, we have revised the rule to provide for "information and procedures" that would assist the reporting of discharges as described in §112.1( b). "Information" refers to the facts which you must report, and "procedures" refers to the method of reporting those facts. Such procedures must address whom the person relating the information should call, in what order the caller should call potential responders and others, and any other instructions necessary to facilitate notification of a discharge as described in §112.1( b). If properly noted, the information and procedures in the Plan should enable a person reporting a discharge to accurately describe information concerning that occurrence to the proper persons in an emergency. Any information or procedure not applicable will not have to be used. Available information on a discharge must be reported. Applicable procedures must be followed. And of course, any information that is not available cannot be reported. Editorial suggestion. In the final rule we have replaced spill with the term "discharge of oil as described in §112.1( b)." If a discharge is fully contained and never reaches navigable water or adjoining shorelines, it need not be reported. Facility address and phone number. In the final rule we have changed address to address or location because some facilities do not have an exact address. Location may mean the longitude and latitude of the facility or some other identifiable means of pinpointing the facility. The phone number must be accurate, if the facility has a phone. Of course, if the facility has no phone, that fact must be noted. State requirements. While it is possible that this information may be duplicative of State requirements, the duplication is eliminated to the extent that you use your State SPCC Plan for Federal SPCC purposes. Where there is no State requirement, there is no duplication. 170 Response plan exemption. We disagree that this paragraph should be placed in a response section, because most SPCC facilities are not required to have response plans, and the information is necessary to prepare for response to an emergency. If your facility has prepared and submitted a response plan to us under §112.20, there is no need to document this information in your SPCC Plan, because it is already contained in the response plan. See §112.20( h)( 1)( i)­( viii). Therefore, we have amended the rule to exempt those facilities with response plans from the requirements of this paragraph. X­ C­ 12 Fault analysis ­ §112.7( b) Background: Proposed §112.7( b) would require an analysis of the major types of failures possible in a facility, including a prediction of the direction, rate of flow, and total quantity of oil that could be discharged as a result of such failures. Comments: Applicability. Large facilities. "Such an effort with its associated risk assessment is very complex and is not needed for most regulated facilities. EPA should specify that such an analysis is only required for very large facilities with potential for major harm to nearby receptors. Small to medium­ sized facilities should limit such analyses to the identification of receptors located in spill pathways." (51, 62, 107, 165, 192, L15, L17) Mobile facilities. We should exempt mobile facilities from the requirement that owners or operators include in the Plan site­ specific information on flow direction, rate of flow, and quantity of oil discharged. Site­ specific information changes when the equipment moves. (128) Present rule adequate. "API believes that the current section 112.7( b) language is clearer and specifically focuses limited resources on situations for which there is a reasonable potential for a discharge. Limited resources should not be consumed in developing flow rate, direction and quantity predictions in the SPCC Plan for situations without a reasonable potential for discharge to navigable waters." (67, 85) The provision is useless and should be deleted. (28, 101, 164) Editorial suggestions. We should replace possible spill pathways with most likely spill pathways to navigable waters. We should explain the need for this provision and allow public review of this explanation before publishing the final rule. The realm of potential pathways would be increased by the inclusion of the EPA­ recommended 25­ year storm event. Our proposal would encourage an exploration and production (E& P) operator to exclude non­ oil­ storage portions of a facility in the Plan, which would increase the "oil pollution potential." (L12) 171 We should replace "direction... of oil... of each major type of failure" with the requirement that the owner or operator include a prediction of "the most likely spill to reach navigable waters." (L12) Electrical equipment. Facilities with electrical equipment should be exempted from this analysis. (125) Failure factors. The rule should clarify how detailed the analysis of potential spill pathways should be. (156) Flowlines or gathering lines. Discharge estimates for these lines would be meaningless and requested that we clarify the provision. (28) For flowlines or gathering lines, it is impossible for the owner or operator to estimate the quantities of oil potentially discharged. (101) Major failures. "First, EPA has not defined a major type of failure and would need to give the regulated community some guidance in this area. If it were tuned to bulk storage tanks, as defined above, this could address tank failures which have the capability of releasing 20, 000 or more gallons." (164) Obvious scenarios. "This provision is totally unnecessary insofar as the Appalachian producers are concerned. It is overly involved for small operators to imagine every conceivable type of failure, and calls for a creative imagination in a place where such is not required. Only obvious scenarios, such as tank rupture or leakage are necessary considerations for anticipating cleanup efforts." (28, 31, 101, 175) Small discharges. "Section 112.7( b) should be clarified to emphasize that the focus of the SPCC Plan should be on assuring that any release is prevented and mitigated, not just `major' releases. Facilities routinely experience and manage smaller releases, while major spills are comparatively rare." (175) Spill history. We should clarify whether we intend to require predicting the number and degree of discharges based upon spill history. Predictions based on this history would be unreliable, and we should delete the provision. (143) Response: Applicability. We agree with the commenter that current language is clearer and will retain it. We therefore modified the first sentence contained in the proposed rule. We agree that the Plan must only discuss potential failure situations that might result in a discharge from the facility, not any failure situation. The rule requires that when experience indicates a reasonable potential for failure of equipment, the Plan must contain certain information relevant to those failures. "Experience" includes the experience of the facility and the industry in general. We disagree that the requirement is too difficult for owners or operators of small or mobile facilities, or of flowlines or gathering lines, or of electrical equipment facilities, or 172 other users of oil. We believe that a Professional Engineer may evaluate the potential risk of failure for the aforementioned facilities and equipment and predict with a certain degree of accuracy the result of a failure from each. We note that since we have raised the regulatory threshold, this requirement will not be applicable to many smaller facilities. We also disagree that our proposal would encourage an exploration and production (E& P) operator to exclude non­ oil­ storage portions of a facility in the Plan, which would increase the "oil pollution potential." A description of the possible direction and rate of flow of discharged oil includes any area over which that oil may flow, including non­ oil portions of a facility. Editorial suggestions. In final §112.7( b), we use the term "a prediction of the direction, rate of flow, and total quantity of oil which could be discharged" instead of the term "possible spill pathways." Failure factors. To comply with this section, you need only address "major equipment" failures. A major equipment failure is one which could cause a discharge as described in §112. 1( b), not a minor failure possibility. To help clarify the type of equipment failures the rule contemplates, we have added examples of other types of failures that would trigger the requirements of this paragraph. Such other equipment failures include failures of loading/ unloading equipment, or of any other equipment known to be a source of a discharge. The analysis required will depend on the experience of the facility and how sophisticated the facility equipment is. If your facility has simpler equipment, you will have less to detail. If you have more sophisticated equipment, you will have to conduct a more detailed analysis. If your facility's experience or industry experience in general indicates a higher risk of failure associated with the use of that equipment, the analysis must also be more detailed. This rationale and analytic detail are also applicable to electrical equipment facilities and other facilities that do not store oil, but contain it for operational use. Again, the required explanation will be tailored to the type of equipment used and the experience with that equipment. Spill pathways. The level of analysis concerning spill pathways will depend on the geographic characteristics of the facility's site and the possibility of a discharge as described in §112.1( b) that equipment failure might cause. However, the Professional Engineer should focus on the most obvious spill pathways. The level of analysis required for prediction of spill pathways is that which may be reasonably foreseen, given the physical location of the facility. We have not included a 25­ year storm event standard in the rule, so that calculation may not be applicable. Because this information is facility specific, the owner or operator of a mobile facility will not be able to detail spill pathways in the general Plan for the facility each time the facility moves. However, the owner or operator must provide management practices in the general Plan that provide for containment of discharges in spill pathways in a variety of geographic conditions likely to be encountered. In case of a discharge at a particular facility, the owner or operator would then take appropriate action to contain 173 or remove the discharge. For example, the Plan may provide that a rig must be positioned to minimize or prevent discharges as described in §112.1( b); or it may provide for the use of spill pans, drip trays, excavations, or trenching to augment discharge prevention. X ­ D: Secondary containment ­ §112.7( c) Background: Section 112.7( c) of the current rule lists appropriate containment and diversionary structures, or equipment, and among other things requires that dikes, berms or retaining walls be "sufficiently impervious to contain spilled oil." In 1991, we proposed to revise §112.7( c) to require that the entire containment system, including the walls and floor, must be impervious to oil for 72 hours. Comments: Applicability. Electric utilities. "Specifically, the Agency has recognized that it is often impracticable to provide at electrical substations the secondary containment required by proposed section 112.7( c)." (125) Flowlines, fired vessels, pressured process vessels. "A statement should be included in the preamble to clarify that section 112.7( c) does not require dikes around flowlines, fired vessels or pressured process vessels at onshore producing facilities. Industry's current practice is to construct dikes primarily around storage tanks. We think that this constitutes `good engineering practice'." (125, 133) Heavy oils. The requirement should not apply to tanks holding No. 5 and No. 6 fuel oils and asphalts. (54) Mining sites. "The proposed containment requirements will be excessive for most mining operations and will require redesign in many instances with little resultant net environmental benefit." (35) Mobile facilities. "Many of these tanks are moved from location to location on a daily basis. Many are too small to require a SPCC Plan or located at a site with sufficient oil capacity to require a SPCC Plan. Secondary containment may not be feasible in these situations." (190) Phase­ in. We should adopt a phased­ in approach so that owners or operators would not have to comply immediately with this new provision. (31, 182) Production facilities. We should exempt production facilities, and allow a contingency plan instead. (28, 31, 86, 165) Underground piping. We should clarify that underground piping is not subject to the rule's secondary containment provisions. (71) 174 Contingency planning or containment. Contingency plan alternative. We should revise the provision to allow owners or operators to use contingency planning in lieu of diking tanks or other equivalent measures. (110) No equivalent. We should place greater emphasis on secondary containment as an oil storage method that has no equivalent. (121) Editorial suggestions. Primary containment system. We should define primary containment system. (71) Surface waters. We should define the term surface waters. We should change surface waters to navigable waters to be consistent with the Clean Water Act. (54, 58, 67, 91, 133, 167, 175) Floors. The impervious requirement should apply only to horizontal releases and not vertical releases, because vertical releases (releases into the ground) do not pose a risk to navigable waters. (48) We should omit any reference to containment "floors" in the final rule, because the purpose of the regulation is to prevent discharge to surface waters and not to ground water. (1155 (1993 commenter)) Impermeability. Support for 72­ hour standard. "Not only is this provision essential to the protection of surface water, it will provide some protection for groundwater. Improperly constructed dikes have resulted in several groundwater pollution problems of significant extent in this state. The Department has recently revised its rules to require relatively impervious dike structures at all sites storing any substance likely to cause pollution of a water of this state. No exemptions to this requirement should be granted because of facility size or quantity of oil stored." (4, 143, 185, L17). Editorial suggestion. We should revise the standard as "impervious to oil and water for 72 hours." (80) Opposition to 72­ hour standard. (11, 25, 31, 35, 42, 48, 57, 66, 67, 71, 72, 74, 75, 78, 85, 86, 91, 101, 102, 110, 114, 116, 125, 155, 156, 164, 170, 173, 175, 177, 182, 184, L3, L30). Current standard is adequate. The current "sufficiently impervious" standard was adequate. (31, 35, 42, 71, 78, 86, 92, 113, 155, L3) 175 No environmental benefit. If adopted, the 72­ hour impermeability standard would require owners or operators to modify existing secondary containment structures. Owners or operators would spend a significant amount of money on these modifications for no additional environmental benefit. (11, 25, 28, 34, 35, 48, 58, 75, 90, 95, 101, 102, 110, 113, 139, 165, 167, 173, 175, 182, 1155 (1993 comment)) Alternate standards. §112.8( c) standard. We should use the language proposed in §112.8( c)( 2) in §112.7( c). The §112.8( c)( 2) approach would permit some contamination of the containment system, without sanctioning an oil discharge to surface waters. (34, 77) Containment instead. The rule should address containment rather than impermeability; the reason for a containment structure is to keep a discharge from reaching navigable waters. (25, 34, 74, 116, 164, 170, L30) Containment or cleanup. We should give facilities a choice between renovating containment to be impervious for 72 hours and providing for the expedient clean­ up of a spill. (90) Liners. "In lieu of a requirement for total imperviousness, specify acceptable liner materials such as compacted clay, plastic, asphalt or concrete, and corresponding levels of acceptable permeability." (107) Monitoring. "While supporting this clarification, it should also be recommended that if a truly impervious containment is not provided, a check should be made of available geological records and documents, site conditions, etc., to assure that such conduits that may cause substantial migration of free product are appropriately monitored for discharges." (76) Alternate time frames. 24 hours, manned facilities. Suggests language requiring the containment system to "be constructed to contain released oil for at least 24 hours" if it is "normally attended during typical work hours." "A requirement this strenuous is unnecessary in situations where personnel are present during a routine workweek." (183) More than 24 hours, unmanned facilities. "As an alternative, this requirement should be revised such that it is applicable only to facilities that go unmanned for more than 24 hours at any one time." (102) 176 36 hours and inspections. In addition to the 72 hour standard, EPA should allow "alternate requirements which would allow for expedient cleanup of spills, e. g., within 36 hours, and/ or an increased frequency of inspections." (90) 72 hours; "As soon as practicable." "If the potential exists for the oil to reach surface waters, then immediate cleanup within 72 hours would be appropriate. For all other types of oil spills, it could be required that clean up measures should be initiated as soon as practicable with proper containment measures in place within 72 hours." (22, 125, L20) "Duration of the emergency response." Containment structures should be "sufficiently impervious to retain oil for the duration of the emergency response." (75, 87) No time limit. "The inclusion of a specific time frame is not necessary. While API would agree that 72 hour retention may be a realistic goal in most cases, we discourage the use of any specified amount of time applied universally and instead recommend that the SPCC regulations establish the intent and allow the regulated community the opportunity to meet that intent." (25, 66, 67, 78, 85, 91, 95, 102, 133, 175) Applicability. Attended facilities. The 72­ hour standard is unnecessary for facilities that are attended 24 hours a day, because facility employees will find a spill within a few hours. (39, 48, 62, 87, 95, 102, 124, 125, 155, 173, 175, 182, L8, L30) This requirement should apply only to those facilities that are unattended. (183, L18) We should require the 72­ hour standard only at a facility that is unmanned for more than 42 consecutive hours. (182) Environmentally sensitive areas. Only owners or operators of facilities in environmentally sensitive areas (e. g., wetlands) should have to meet the 72­ hour standard. (114) New facilities only. The 72­ hour impermeability requirement should apply to new facilities only. (165, 182, 192) Calculation of 72 hours. Asks when 72 hours begins to run, from discovery of the discharge or time of occurrence. (82) Clarification of "impervious" needed. We should further define "impervious to oil for 72 hours" in the proposed standard. (9, 34, 58, 67, 68, 70, 71, 76, 81, 83, 87, 91, 92, 95, 98, 101, 107, 114, 115, 117, 125, 133, 179, 182, 187, L2, L12) We should define impervious in terms of engineering standards. (27, 57, 87, 101, 114, 135, 175, 177, 186, 190) 177 Good engineering practice. We should revise the standard to make clear that the impervious determination should be based on good engineering practice. (125) Showing impermeability. Asks how to prove that facility secondary containment systems are impervious. (10, 28, 58, 66, 101, 113, 125, 155, 156, 165, 179, 190) It would be too costly to prove that secondary containment systems were impervious. (28, 90, 101, 113, 165, 182) Methods of secondary containment. Alternative structures. Alternative secondary containment structures are impracticable at small facilities. (182) Earthen structures. "An arbitrary requirement that a dike be `impervious' could be interpreted to require replacement of almost all of the existing containment systems for production locations, most of which have earthen dikes. Such containment systems prevent oil from migrating offsite to waters but may not be completely `impervious. ' Given the low level of risk presented by such facilities, with their typically low volumes of storage, IPAA does not believe that the proposed requirements are justified." (28, 31, 34, 39, 67, 74, 75, 77, 86, 91, 101, 107, 110, 113, 133, 164, 165, 167, 186, 187, 195, L30) Factory fabricated. We should clarify whether forms of construction with factory fabricated secondary containment are equivalent forms of construction. (140) Flexibility. We should maintain flexibility in allowing owners or operators to use one or more secondary containment systems. (39, 54, 70, 71) We should provide owners or operators flexibility to meet the protection standard in a way that is cost effective to them. (184) Sorbents or booms. We should remove sorbent materials or booms from the list of acceptable secondary containment structures because they are not a substitute for impervious dikes and impoundment floors. (111) Sump pump or catchment basin. Sump pumps, catchment basins, or other methods listed in §112.9( b)( 2) might be sufficient. (28, 31, 167) Response: Applicability of requirement. Secondary containment is best for most facilities storing or using oil because it is the most effective method to stop oil from migrating beyond that containment. We believe that secondary containment is preferable to a contingency plan at manned and unmanned facilities because it prevents discharges as described in §112.1( b). At unmanned facilities, it may be even more important because of the lag in time before a discharge may be discovered. Notwithstanding what may be difficult terrain, we believe that some form of secondary containment is practicable at most facilities, including remote production facilities. In 178 fact, it may often be more feasible in remote or rural areas because there are fewer space limitations in such areas. For example, at some remote mobile or production facilities, owners or operators dig trenches and line them for containment or retention of drilling fluids. Technologies used at offshore facilities to catch or contain oil may also sometimes be used onshore. While some types of secondary containment (for example, dikes or berms) may not be appropriate at certain facilities, other types (for example, diversionary systems or remote impounding) might. However, we recognize and repeat, as we noted in the 1991 preamble, that some or perhaps all types of secondary containment for certain facilities with equipment that contain oil, such as electrical equipment, may be contrary to safety factors or other good engineering practice considerations. There might be other equipment, like fired or pressurized vessels, for which safety considerations also preclude some or all types of secondary containment. Some facilities or equipment that use but do not store oil may or may not, as a matter of good engineering practice, employ secondary containment. Such facilities might include wastewater treatment facilities, whose purpose is not to store oil, but to treat water. Other facilities that may not find the requirement practicable are those that use oil in equipment such as hydraulic equipment. Similarly, flowlines must have a program of maintenance to prevent discharges. See §112.9( d)( 3). The maintenance program may or may not include secondary containment. Owners or operators of underground piping must have some form of corrosion protection, but do not necessarily have to use secondary containment for that purpose. As stated above, for a facility where secondary containment is not practicable, the owner or operator is not exempt from the requirement, but may instead provide a contingency plan and take other measures required under §112.7( d). For most facilities, however, including small facilities, mobile facilities, production facilities, mining sites, and any other facilities that store or use oil, we believe that secondary containment is generally necessary and appropriate to prevent a discharge as described in §112.1( b). Without secondary containment, discharges from containers would often reach navigable waters or adjoining shorelines, or affect natural resources. Completely buried tanks. Completely buried tanks which are not exempted from this rule because they are subject to all Federal or State UST requirements are subject to the secondary containment requirement. We realize that the concept of freeboard for precipitation is inapplicable to secondary containment for completely buried tanks. The requirement for secondary containment may be satisfied in any of the ways listed in the rule or their equivalent. Contingency planning or containment. A contingency plan should not be used routinely as a substitute for secondary containment because we believe it is normally environmentally better to contain oil than to clean it up after it has been discharged. Secondary containment is intended to contain discharged oil so that it does not leave the facility and contaminate the environment. The proper method of secondary 179 containment is a matter of good engineering practice, and so we do not prescribe here any particular method. Under part 112, where secondary containment is not practicable, you may deviate from the requirement, provide a contingency plan following the provisions of 40 CFR part 109, and comply with the other requirements of §112.7( d). For bulk storage containers, those requirements include both periodic integrity testing of the containers and periodic integrity and leak testing of the valves and piping. You must also provide a written commitment of manpower, equipment, and materials to expeditiously control and remove any quantity of oil discharged that may be harmful. Double­ walled or vaulted tanks. The term "vaulted tank" has been used to describe both double­ walled tanks (especially those with a concrete outer shell) and tanks inside underground vaults, rooms, or crawl spaces. While double­ walled or vaulted tanks are subject to secondary containment requirements, shop­ fabricated double­ walled aboveground storage tanks equipped with adequate technical spill and leak prevention options might provide sufficient equivalent secondary containment as that required under §112.7( c). Such options include overfill alarms, flow shutoff or restrictor devices, and constant monitoring of product transfers. In the case of vaulted tanks, the Professional Engineer must determine whether the vault meets the requirements for secondary containment in §112.7( c). This determination should include an evaluation of drainage systems and of sumps or pumps which could cause a discharge of oil outside the vault. Industry standards for vaulted tanks often require the vaults to be liquid tight, which if sized correctly, may meet the secondary containment requirement. There might also be other examples of such alternative systems. Editorial suggestions. Primary containment system. In response to the commenter's question, we note that a primary containment system is the container or equipment which holds oil or in which oil is used. Surface waters. We do not use the term "surface waters" in the final rule. We revised the proposed phrase, "escape to surface waters" to read "escape from the containment system" to reflect more clearly the intent of the rule that secondary containment should keep oil from escaping from the facility and reaching navigable waters or adjoining shorelines. 72­ hour impermeability standard. We are withdrawing the proposal for the 72­ hour impermeability standard and will retain the current standard that dikes, berms, or retaining walls must be sufficiently impervious to contain oil. We agree with commenters that the purpose of secondary containment is to contain oil from escaping the facility and reaching the environment. The rationale for the 72­ hour standard was to allow time for the discovery and removal of an oil spill. An owner or operator of a facility should have flexibility in how he prevents a discharge as described in §112. 1( b), 180 and any method of containment that achieves that end is sufficient. Should such containment fail, the owner or operator must immediately clean up any discharged oil. Similarly, because the purpose of the "sufficiently impervious" standard is to prevent discharges as described in §112.1( b), dikes, berms, or retaining walls must be capable of containing oil and preventing such discharges. Discharges as described in §112.1( b) may result from direct discharges from containers, or from discharges from containers to groundwater that travel through the groundwater to navigable waters or adjoining shorelines. Effective containment means that the dike, berm, or retaining wall must be capable of containing oil and sufficiently impervious to prevent discharges from the containment system until it is cleaned up. The same holds true for container floors or bottoms; they must be able to contain oil to prevent a discharge as described in §112.1( b). However, "effective containment" does not mean that liners are required for secondary containment areas. Liner are an option for meeting the secondary containment requirements, but are not required by the rule. If you are the owner or operator of a facility subject to this part, you must prepare a carefully thought­ out Plan in accordance with good engineering practice. A complete description of how secondary containment is designed, implemented, and maintained to meet the standard of sufficiently impervious is necessary. In order to document that secondary containment is sufficiently impervious and sufficiently strong to contain oil until it is cleaned up, the Plan must describe how the secondary containment is designed to meet that standard. A written description of the sufficiently impervious standard is not only necessary for design and implementation, but will aid owners or operators of facilities in determining which practices will be necessary to maintain the standard of sufficiently impervious. Control and/ or removal of vegetation may be necessary to maintain the impervious integrity of the secondary containment. Repairs of excavations or other penetrations through secondary containment will need to be conducted in accordance with good engineering practices in order to maintain the standard of sufficiently impervious. The owner or operator should monitor such imperviousness for effectiveness, in order to be sure that the method chosen remains impervious to contain oil. We note that we have withdrawn the proposed 72­ hour standard, and afford various secondary containment options, including earthen dikes and diked areas, if they contain and prevent discharges as described in §112.1( b). Therefore, there are no new costs. We disagree with the commenters who asserted that we underestimated the cost to comply with the secondary containment and truck loading area requirements. The revised rule, like the current rule, does not require a specific impermeability for dikes and does not require a specific method of secondary containment at loading areas, and this flexibility is reflected in our cost estimates. We noted in our 1991 Supplemental Cost/ Benefit Analysis that secondary containment for bulk storage tanks is estimated to cost $1, 000 for small facilities; $6, 400 for medium facilities; and $63,000 for large facilities. Unit cost estimates were developed for a broad mix of facilities (e. g., farms, bulk petroleum terminals) in each size category by experienced engineers with firsthand knowledge of the Oil Pollution Prevention 181 Regulation and the operations of onshore SPCC­ regulated facilities. Because our cost estimates must be representative of the many types of facilities that are regulated, they will underestimate the costs for some facility types and overestimate the costs for others. Facilities were assumed to construct secondary containment systems of impervious soil capable of holding 110 percent of the largest tank. In that analysis, we estimated that 78 percent and 88 percent of the regulated community were already in compliance with these requirements, respectively, and would not be affected by the proposed rule change. Since we last performed these analyses, API has issued several industry standards, including API 653 and 2610, which address many of the provisions in the SPCC rule. As a result, the final rule relies on current industry standards and practices, where feasible. In the final rule, we withdrew the proposed 72­ hour impermeability standard for secondary containment and maintained the current requirement that dikes, berms, and oil retaining walls must be sufficiently impervious to contain oil. As a result, the final rule reflects current industry standards and we assume poses no additional requirements on industry. Industry standards. Industry standards that may assist an owner or operator with secondary containment include: (1) NFPA 30; (2) BOCA, National Fire Prevention Code; and, (3) API Standard 2610, "Design, Construction, Operation, Maintenance, and Inspection of Terminal and Tank Facilities." Methods of secondary containment. We disagree that we should remove sorbent materials and booms from the list of acceptable secondary containment structures. The appropriate method of secondary containment is an engineering question, and therefore we do not prescribe any particular method. Double­ walled piping may be an option, but is note required by these rules. Earthen or natural structures may be acceptable if they contain and prevent discharges as described in §112.1( b), including containment that prevents discharge of oil through groundwater that might cause a discharge as described in §112. 1( b). What is practical for one facility, however, might not work for another. If secondary containment is not practicable, then the facility must provide a contingency plan following the provisions of 40 CFR part 109, and otherwise comply with §112.7( d). Sufficient freeboard. See the Response to Comments in §112.8( c)( 2) for a discussion of this topic. X­ E Contingency planning X­ E­ 1 ­ 1991 and 1993 proposals Background: 1991 proposal. Current §112.7( d) requires that, when an owner or operator determines that secondary containment is impracticable, he must demonstrate this impracticability and prepare a strong oil spill contingency plan following the provisions of 40 CFR part 109. In 1991, we proposed several new requirements in 182 §112.7( d). We proposed language clarifying that the owner or operator must submit the contingency plan to the Regional Administrator (RA) for approval. Further, we replaced the reference to 40 CFR part 109 with a list of basic requirements for an oil spill contingency plan. We proposed language requiring that the owner or operator make the contingency plan a stand­ alone section of the Plan; and, that he not rely upon response methods other than containment and physical removal of oil from the water (e. g., not rely on dispersants or other chemicals), unless the RA approved such response methods. We also asked for general comments on Phase Two contingency planning, and specific comments and supporting data on contingency planning needs. Under §112.7( d)( 2) of the current rule, the owner or operator of a facility without secondary containment must provide a written commitment of manpower, equipment, and materials required to expeditiously control and remove any harmful quantity of discharged oil as part of his contingency plan. In 1991, we proposed in §112.7( d)( 2) a recommendation that the facility owner or operator consider factors such as financial capability in making the written commitment of manpower, equipment, and materials. 1993 proposal. In 1993, we modified the 1991 proposal for a facility that lacks secondary containment to require a facility response plan as described in §112.20, instead of the specific requirements proposed in 1991. The response plan would not be submitted to the Regional Administrator for his review, unless otherwise required, but would be maintained at the facility with the SPCC Plan. Comments: Support for proposal. Support for proposal for elementary contingency planning requirements. ( 61, 91, 175) Support for contingency planning as an alternative when secondary containment is impracticable. (90, 125) We should separate prevention and response plan rules. (121) Expanded requirements. "3M believes that requirements for even elementary contingency plans should be expanded during this rulemaking to include additional factors. ... Accordingly, 3M believes the SPCC regulation should expressly require the calculation of a worst case scenario as part of each contingency plan. ... 3M believes the SPCC regulation should require each contingency plan to document the availability of enough sorbent material and other equipment to manage a worst case spill. ... The regulation should state that the plan must provide for: employee training in implementation of the plan, including practice drills; availability of protective gear for all employees who may be called upon to respond to a spill; and, timely restocking of sorbents and protective gear after use. 3M also supports EPA's plan to develop more detailed requirements for contingency plans, including vulnerability analyses and event and fault tree analyses, as part of the Phase Two rulemaking." (61, 107) Response planning and 1993 contingency planning proposal ­ Phase II. Leak detection. At no time should we require installing leak detection systems or conducting vulnerability, and event and fault tree analyses at a facility with 183 adequate secondary containment. (51, 57, 67, 155, 191) In the Phase Two regulations, we should require owners or operators to install these systems for all SPCC facilities, because secondary containment could not be effective for an underground spill and early detection should be a priority. (L1) Performance standards. We should avoid making the Phase Two planning standards like performance standards. We should not initiate an enforcement action against an owner or operator who failed to follow "a script or scenario laid down during the planning process." (133) Requirements premature. "API opposes as premature, facility­ specific contingency plan information needs (i. e., discovery of a spill, emergency notification procedures, name of the spill response coordinator, procedures for identifying personnel and equipment that may be needed, available equipment lists, available personnel lists, an identification of hazards, a vulnerability analysis, and an event and fault tree analysis.) Until EPA fully defines, in the Phase Two rulemaking, the scope and limitation of these terms, justifies the informational needs in terms of protection of human health and the environment, and demonstrates that it is statutorily authorized to collect such information, it is premature to require it at this time. Area Committees, as mandated by the OPA, will be developing this information directly." (67) "The Agency's position appears to be that specific contingency planning requirements will be developed in its Phase II rulemaking. However, this is of little help to facilities that must develop contingency plans to meet Phase I requirements. Therefore, we recommend that the Agency defer the requirement to prepare contingency plans until promulgation of the Phase II rules." (125) We should require contingency planning only as part of Phase Two for facilities with the potential to cause substantial harm. (L12) Secondary containment, not a contingency plan. "New York State does not accept contingency plans in­ place of a secondary containment system. We recommend that all facilities threatening ground or surface waters have secondary containment facilities." (111) Vulnerability analysis. The discussion of vulnerability, event and fault tree analyses is confusing in connection with the actual proposal in the Phase One rulemaking. (34) "Such analyses should not be required for facilities with secondary containment. Furthermore, if EPA should require these analyses, the analyses should encompass readily available information and EPA should use only clearly understood criteria in asking for information." (57, 89, 101, 107, 114, L15). Downstream water suppliers. "It is proposed that, under Phase II, a site­ specific contingency plan will include a vulnerability analysis, one element of which would be notification of drinking water suppliers [downstream]. Pennsylvania currently has such a requirement that could be considered to have a flaw. The 184 Pennsylvania requirement is that oil storage facilities must identify water users for 20 miles downstream, and update that list every year. Because the primary source of such information is at offices of each county, the demands on the facilities and county offices is excessive. In addition, facilities may not identify a new water user for nearly a year." (76) Response: Support for proposal. We appreciate support for the proposal, but modified that proposal in 1993. See the preamble to today's final rule and section 4 of the 1993 Comment Response Document for a discussion on contingency planning. See below for comments related to the extant 1991 proposal. Response planning and 1993 contingency planning proposal ­ Phase II. For an indepth discussion of issues in the Phase Two rulemaking, see the FRP preamble and final rule (59 FR 34070, July 1, 1994), the Phase Two docket (SPCC­ 2P), and the preamble to today's final rule. See the preamble to today's final rule, section 4 of the 1993 Comment Response Document for a discussion on contingency planning, and sections X­ E, F, and G of this document. X­ E­ 2 General ­ §112.7( d) Background. In 1991, we proposed to add language to §112.7( d)( 1) listing the basic requirements for an oil contingency plan, including the phrase "and such other information as required by the RA." Comments: Additional information. This language is too broad and would subject facilities to unknown regulation. We should clearly specify what additional information would be required by t3he RA or change the language to state "such other information as the RA may reasonably require." (103) The contents should include at least the same requirements as those found in the Oil Pollution Act (OPA) amendments to the Federal Water Pollution Control Act (FWPCA). (171) Applicability. Aboveground tanks. Proposed §112.7( d) should be applicable to fixed aboveground tanks only. (102) Buried piping, buried tanks, portable tanks. Questions whether it was our intent to require facilities "with buried piping, buried tanks, or portable tanks for which secondary containment cannot be provided" to prepare and submit an SPCC Plan. (102) Electrical equipment. "The electric utility strongly supports the inclusion in the SPCC rules of an alternative to secondary containment/ drainage control requirements where such controls are demonstrated to be impracticable. This provision adds needed flexibility to the rule and again allows the owner or operator to use good engineering practices in adapting the goals of the SPCC 185 program to unusual facilities. As the Agency has recognized, secondary containment is impracticable at many electric utility substations." (125) FRP facilities. Re §112.7( d): "When response plans are to be required of all facilities, this paragraph should be deleted." (121) Large facilities. "Suggest that contingency plan for "large facilities" only be provided to Regional Administrator." (62) Production facilities. "Facility specific contingency plans are not practicable in many cases, particularly as they relate to onshore oil production operations. The profitability of these operations, especially stripper operations, would be utterly destroyed by the costs associated with preparation, implementation, review, revision, and other work associated with contingency planning." (42, 58) Production flowlines and trunklines. "Language should be included that excludes production flowlines and trunklines from this requirement. At most production facilities, dikes are installed around tank batteries, but not around flowlines because it is impractical to do so. As written, the regulation would require submission of spill contingency plans for all such facilities." (167) Rack to tank piping. "Proposed section 112.7( d) does not specifically address pipes running from the terminal rack to a tank( s), that will be by necessity outside of secondary containment. IFTOA believes that the facility should maintain a contingency plan to address potential discharges from such pipes reviewed and certified by the PE." (54) Clarifications. Contingency plan vis­ a­ vis Facility Response Plans. Asks if we intend the terms facility specific response plan and contingency plan as used in the preamble to mean the same thing. (54) Costs. Contingency planning is not practicable because the costs are too high. However, these commenters did not provide specific cost estimates. (42, 101, 110, 113, 114, L15) We should "be sensitive to the interest and concerns" of small businesses in developing the Phase Two rule. (48) "It is recommended that the Agency's current strategy of requiring elementary contingency planning steps be continued for SPCC Plans for small facilities." (101) Dispersants. "While it is desirable to obtain approval from the Regional Administrator before using dispersants, NJDEPE is concerned about how state approvals of such use will be handled. NJDEPE's rules presently require approval of either this department or the federal on­ scene coordinator. Would this approval be sufficient under this proposal?" (147) 186 Disposal of recovered oil and other materials. Favors proposal. "We strongly agree that provisions for waste disposal should be addressed in contingency plans, including provisions for the temporary storage of recovered oil and oily waste." (193) Opposes proposal. "The SPCC Plan should focus on spill control and countermeasures rather than disposal of discharged substances, since the disposal of recovered oil, used sorbents, and other materials is regulated by state regulations, by RCRA, or existing federal regulations." (L30) EPA review and approval. "It is not clear from the proposal whether such a contingency plan must be reviewed and approved by the Registered PE or the RA of EPA. Review by the RA is duplicative, time­ consuming, and unnecessary." (54) Our proposed requirement that owners or operators submit contingency plans to the RA would require the RA to review and approve a substantial number of plans. (58) We should delete the contingency plan submittal requirement because the RA already has the authority under §112.4 to call for Plans from those facilities that may be defined as "problem facilities." (101) "It does not state that it must be provided to the Regional Administrator any more than the SPCC Plan must be provided. It must be provided if requested by the Regional Administrator, but the preamble language infers that submittal of every contingency plan to the RA is automatic upon being developed." (165, L15) Electrical equipment facilities. Questions whether we would be able to both review and approve all submitted plans within an acceptable time frame and maintain program credibility. (111) "It is unnecessarily burdensome and expensive, however, to submit such plans to the Agency for numerous substations." (161) " Review times. "In addition, such a review process could result in project delays. If the Agency intends to pursue this requirement, the regulations should address a reasonable deadline (such as 30 days) that the Agency would have to review and approve the contingency plan." (90, 161) We should clarify whether the contingency plan would be due to the RA within two months of the effective date of the final rule. We should allow owners or operators at least six months to update their existing SPCC Plans. (141) Financial responsibility. The reference to "financial responsibility requirements" is superfluous. Equipment, personnel, and other spill­ related expenses are operating expenses for most manufacturing entities, and would impose no financial responsibility. (162) Formats. 187 Generic contingency plans (electrical substations). "Since all substations are very similar in design and spill response would be conducted by the same personnel, PEO suggests that use of more generic, area wide contingency plans be allowed for facilities such as substations." (41) HAZWOPER Plans. "The contingency plan requirement should be dropped for `small size facilities' which have a HAZWOPER plan and trained response team." (62, 152) RCRA contingency plan. "The elements discussed that would make up the Contingency Plan are similar in nature to those that the RCRA regulations require for hazardous storage facilities. In an effort to minimize redundancy, the RCRA Contingency Plan should be allowed to be used in lieu of a separate Contingency Plan to satisfy this rule." (87, 186) Specific format. "Finally, we recommend the oil spill response plan required under 40 CFR 112.7( d) specify a specific format for its development. We recommend that the contents include at least the same requirements found in the OPA amendments to the FWPCA." (171) Stand alone section. Should not stand alone. "If a discharge occurs, personnel may need to respond to operation and maintenance procedures, as well as responding to a cleanup. Referring to two sections for one discharge is not effective." (38) Should stand alone. "Maintaining the contingency plan as a separate section of the SPCC plan makes good operational sense. Large documents which contain non­ essential information are seldom if ever used, and difficult to use." (62, 190) Location of contingency plan. We should require the owner or operator to keep the contingency plan on­ site at the facility and available for the RA's review during normal working hours. This would reduce the unnecessary administrative burden associated with submission of the contingency plan. (90) Mandatory secondary containment. We should require secondary containment for all facilities threatening ground or surface waters. Contingency plans will not stop petroleum from reaching surface waters as effectively as "in­ place properly designed and maintained secondary containment systems." (111) PE certification. Asks if it is necessary for a Professional Engineer to certify a contingency plan. (121) Practicability. Our definition of practicable is not specific enough. We should provide guidance on practicability, otherwise, owners or operators may base practicability on 188 the economics of preparing a contingency plan rather than installing prevention equipment. (1153 (1993 commenter)) Scope of the contingency plan. "... EPA should make clear that a contingency plan is required for that portion of the facility that is outside of secondary containment." (54) Response: Additional information. We have modified the 1991 proposal by withdrawing proposed §112.7( d)( 1). We also have withdrawn the 1993 proposal which would have required a response plan for a facility lacking secondary containment. Applicability. Under the current rule, contingency planning is necessary whenever you determine that a secondary containment system for any part of the facility that might be the cause of a discharge as described in §112.1( b) is not practicable. This requirement applies whether the facility is manned or unmanned, urban or rural, and for large and small facilities. Facility components that might cause a discharge as described in §112.1( b) include containers, piping, valves, or other equipment or devices. Contingency planning is necessary for all facilities to avert and adequately respond to discharges as described in §112.1( b) regardless of facility size, if the facility lacks secondary containment. It is also necessary in areas historically not subject to natural disasters, because spills can also be caused by human error or mechanical failures. Completely buried tanks. We note that completely buried tanks, as defined in §112.2, and connected underground piping, underground ancillary equipment, and containment systems that are subject to all of the technical requirements of 40 CFR part 280 or a State program approved under 40 CFR part 281 are not subject to part 112. 40 CFR 112.( d)( 2)( i). Those tanks, piping, and ancillary equipment that remain subject to the SPCC program are therefore subject to contingency planning requirements in the appropriate case. Electrical equipment. Any facility without secondary containment must prepare a contingency plan when secondary containment is not practicable. See the discussion under §112.7( d) in today's preamble. We disagree that the preamble language should be construed as granting a blanket impracticability determination to any facility (including facilities with electrical equipment). Such a determination is a facility­ specific one. FRP facilities. In response to comment, we have revised the rule to exempt from the contingency planning requirement any facility which has submitted a response plan under §112.20 because such a response plan is more comprehensive than a contingency plan following part 109. We disagree that facility response planning is beyond our statutory authority, since it is a procedure or method to remove discharged oil. See section 311( j)( 1)( A) of the CWA. However, while we disagree that such planning is expensive and lacking in environmental benefit, we agree that the current contingency plan arrangements which reference 40 CFR part 109 should be 189 sufficient to protect the environment, and that a facility response plan as described in §112.20 is therefore unnecessary for a facility that is not otherwise subject to §112.20. We agree with the commenter that structures or equipment might achieve the same or equivalent protection as response planning for some SPCC facilities. Therefore, we are withdrawing that part of the 1993 proposal related to response planning in proposed §112.7( d)( 1), but are retaining the current contingency planning provisions, which require a contingency plan following the provisions of 40 CFR part 109. We also believe that response plans should be reserved for higher risk facilities, as provided in §112. 20. Clarifications. Contingency plan vis­ a­ vis Facility Response Plans. The terms facility specific response plan (FRP) and contingency plan have different meanings. The oil spill contingency plan is part of the SPCC Plan, required when secondary containment is not practicable at a facility. The FRP, addressed in §§ 112.20­ 21, is separate from the SPCC Plan, and is required only for a certain subset of SPCC facilities. Costs. We note that we did not finalize the 1991 or 1993 contingency planning proposals. Thus there are no new costs for such planning. Dispersants. We withdrew the proposed reference to the use of dispersants in §112.7( d) in 1993. Dispersant use is governed by subpart J of the NCP. EPA review and approval. We have withdrawn the proposed submittal requirement because we believe it is sufficient that the contingency plan be available for on­ site inspection. The contingency plan must be made a part of the SPCC Plan, and therefore, PE certification is required. In certifying the SPCC Plan, the PE attests that the owner's or operator's judgment of impracticability is correct. Disposal of recovered oil and other materials. We agree that we should not require an owner or operator to address the disposal of recovered oil and other materials in a facility­ specific contingency plan because this discussion is already required under §112.7( a)( v). Financial responsibility. We have deleted the proposed recommendation concerning financial capability in making written commitments of manpower, equipment, and materials from the rules because we do not wish to confuse the regulated community by including discretionary requirements in a mandatory rule. Formats. For §112.7 contingency planning requirements, an owner or operator may use a contingency plan prepared under other State or Federal authority as long as the plan follows part 109, or is supplemented so that it meets all of part 109's requirements. 190 Generic contingency plans (electrical substations). We agree that an owner or operator may create a multi­ facility contingency plan. Such plan must include all elements required for individual contingency plans. It must also include sitespecific information. However, the site specific information might be maintained in a separate location, such as a central office, or an electronic data base, as long as such information is immediately accessible to responders and inspectors. Where you place that site­ specific information is a question of allowable formatting, an issue subject to RA discretion. HAZWOPER Plans. The RA has discretion to accept any format that meets the requirements of 40 CFR part 109. Where such alternate format does not meet all of part 109's requirements, the owner or operator may supplement it so that it does. RCRA. A contingency plan prepared under RCRA rules might suffice for purposes of the rule if the plan fulfills the requirements of part 109, and the PE certifies that such plan is adequate for the facility. If the RCRA contingency plan satisfies some but not all SPCC requirements, you must supplement it so that it does. Specific format. It is unnecessary to specify a format for a contingency plan because we do not believe that there is a single format applicable to all facilities. Stand alone section. We have withdrawn the proposed requirement that the contingency plan be a stand­ alone section of the SPCC Plan. The owner or operator has flexibility to determine where to incorporate the contingency plan within the SPCC Plan. Location of contingency plan. Today we have finalized the 1991 proposal that the Plan must be available at the facility if it is normally attended at least four hours per day, or at the nearest field office if it is not so attended. A Plan must always be available without advance notice, because an inspection might not be scheduled. You are not required to locate a Plan at an unattended facility because of the difficulty that might ensue when emergency personnel try to find the Plan. However, you may keep a Plan at an unattended facility. If you do not locate the Plan at the facility, you must locate it at the nearest field office. Mandatory secondary containment. We agree that an in­ place, properly designed, and maintained secondary containment system is the most effective way to prevent a discharge as described in §112. 1( b). However, for certain facilities, secondary containment may not be practicable because of geographic limitations, local zoning ordinances, fire prevention standards, or other good engineering practice reasons. Part 109 requirements. In following the provisions of part 109, you must address the oil removal contingency planning criteria listed in 40 CFR 109.5 and ensure that all response actions are coordinated with governmental oil spill response organizations. 191 The absence of secondary containment will place extreme importance on the early detection of an oil discharge and rapid response by the facility to prevent that discharge. Part 109 was originally promulgated to assist State and local government oil spill response agencies to prepare oil removal contingency plans in the inland response zone, where EPA provides the On­ Scene Coordinator. The basic criteria for contingency planning listed in §109.5 apply to any SPCC regulated facility that has adequately justified the impracticability of installing secondary containment, irrespective of whether it is a government agency or the facility is located in the coastal (U. S. Coast Guard) or inland (EPA) response zone. Because the contingency plan involves good engineering practice and is technically a material part of the Plan, PE certification is required. PE certification. The contingency plan is a technical part of the SPCC Plan which must be certified by a PE. Practicability. We believe that it may be appropriate for an owner or operator to consider costs or economic impacts in determining whether he can meet a specific requirement that falls within the general deviation provision of §112.7( a)( 2). We believe so because under this section, the owner or operator will still have to utilize good engineering practices and come up with an alternative that provides "equivalent environmental protection." However, we believe that the secondary containment requirement in §112.7( d) is an important component in preventing discharges as described in §112.1( b) and is environmentally preferable to a contingency plan prepared under 40 CFR part 109. Thus, we do not believe it is appropriate to allow an owner or operator to consider costs or economic impacts in any determination as to whether he can satisfy the secondary containment requirement. Instead, the owner or operator may only provide a contingency plan in his SPCC Plan and otherwise comply with §112. 7( d). Therefore, the purpose of a determination of impracticability is to examine whether space or other geographic limitations of the facility would accommodate secondary containment; whether local zoning ordinances, fire prevention standards, or safety considerations would prohibit the installation of secondary containment; or, if the installation of secondary containment would defeat the goal of the regulation to prevent discharges as described in §112.1( b). Review of contingency plans. We note that the preamble to the 1993 proposed rule (at 58 FR 8841) suggested that response plans would not have to be submitted to the Regional Administrator unless "otherwise required by the rest of today's proposed rule." However, proposed §112.7( a)( 2) would have required that the owner or operator submit to the Regional Administrator any Plan containing a proposed deviation, including a deviation for the general secondary containment requirements in §112.7( c). In any case, we agree with commenters that the contingency plan (or any other deviation) should not have to be submitted to the Regional Administrator for his review and approval because we believe that it is sufficient that the contingency plan (or other deviation) be available for on­ site inspection. We have therefore withdrawn that part of the proposal. See also the discussion on §112.7( a)( 2). 192 Scope of the contingency plan. The contingency plan is applicable to the entire facility because it involves the capacity of the entire facility to prepare for and respond to a discharge as described in §112.1( b). Small facilities. We disagree that contingency planning is too costly for small facilities. Such planning helps to save money when a discharge occurs. The requirements for contingency planning are fewer than the requirements for response planning. Response planning is required only for higher storage, higher risk facilities. Written commitment. A "written commitment" of manpower, equipment, and materials means either a written contract or other written documentation showing that you have made provision for those items for response purposes. Such commitment must be shown by: the identification and inventory of applicable equipment, materials, and supplies which are available locally and regionally; an estimate of the equipment, materials, and supplies which would be required to remove the maximum oil discharge to be anticipated; and, development of agreements and arrangements in advance of an oil discharge for the acquisition of equipment, materials, and supplies to be used in responding to such a discharge. 40 CFR 109.5( c). The commitment also involves making provisions for well defined and specific actions to be taken after discovery and notification of an oil discharge including: specification of an oil discharge response operating team consisting of trained, prepared, and available operating personnel; predesignation of a properly qualified oil discharge response coordinator who is charged with the responsibility and delegated commensurate authority for directing and coordinating response operations and who knows how to request assistance from Federal authorities operating under current national and regional contingency plans; a preplanned location for an oil discharge response operations center and a reliable communications system for directing the coordinated overall response actions; provisions for varying degrees of response effort depending on the severity of the oil discharge; and, specification of the order of priority in which the various water uses are to be protected where more than one water use may be adversely affected as a result of an oil discharge and where response operations may not be adequate to protect all uses. 40 CFR 109.5( d). X ­ F: Integrity and leak testing ­ §112.7( d) Background: Section 112.7( d) of the current rule sets out requirements for a facility when secondary containment is not practicable. In such cases, the owner or operator must explain the impracticability; provide a contingency plan following the provisions in 40 CFR part 109; and provide a written commitment of manpower, equipment, and materials to control and remove any harmful quantity of discharged oil. In 1991, we proposed adding a requirement in §112.7( d) for the owner or operator of a facility without secondary containment to conduct integrity tests of tanks at least once every five years. We also proposed adding a requirement for integrity and leak testing of valves and piping at least once a year. 193 Comments: Alternatives to integrity testing. Engineering evaluation instead. Rather than requiring an owner or operator to conduct integrity tests of underground piping, we should require an owner or operator to conduct an "engineering evaluation" of unprotected, underground piping to test its integrity. (67, 91) Applicability. Ancillary equipment. "..., because spills and leaks most commonly occur due to equipment failures related to piping, valves, and pumps, ATA recommends expanding the integrity test to cover ancillary equipment. The same 5­ year and 10­ year testing schedules proposed for tanks are reasonable for ancillary equipment." (107) Electrical equipment. "... this provision is impracticable because certain types of electrical equipment, such as underground transmission cable systems, cannot be integrity tested, while ones that can be tested, such as transformers, must be taken out of service to be tested. Moreover, this requirement is unnecessary because electrical equipment in service is constantly being tested because the equipment will fail if there is a leak." (74, 125, 156, 158, 183, 189, 192) It is unnecessary and inappropriate to apply the §112.7( d) integrity testing requirements to oil­ filled equipment, because typical substation transformers are protected by alarm systems sufficient to alert operators of leaks. Integrity testing this equipment would result in an unnecessary expense. (158) "This is another instance where a size differential could be used to exempt oil­ filled electrical equipment from these inappropriate and unnecessary requirements." (183) Fixed aboveground piping. Proposed §112.7( d) should apply only to fixed aboveground piping that lacks secondary containment. It appears that §112.7( d) applies to aboveground and underground tanks, valves, and piping; and it is highly unlikely for buried tanks, piping, or valves to have secondary containment. Further, proposed §112.7( d) "defeats the discretionary testing schedule contained in §§ 112. 8( c)( 4) for buried metallic tanks and 112. 8( d)( 4) for buried piping." (102) Flowlines and gathering lines. "Further, the alternate to 40 CFR section 112.7( c) requires flow lines testing. The pressure test provision offer little advantage over normal flowline pressure, which is present at all times. Typically, flowline leaks are small and routine inspection at road crossings provides sufficient protection from oil entering Waters of the U. S. However, the voluntary Contingency Plan requirement provides added protection." (110) The required annual pressure testing of flowlines and gathering systems would be costly for small operators. We should exclude flowlines and gathering systems from the §112.7( d) testing provisions. (28, 31, 101,165, L15). 194 Impracticality. We should not require annual integrity leak testing of tanks where installation of secondary containment is impractical. Monthly visual inspection of tanks, valves, and aboveground piping provides adequate protection to the environment. (1155 (1993 commenter)) Phase­ in. We should require tanks subject to §112.7( d) to comply with the provisions within five years of the promulgation date of the final rule and every five years thereafter. (125) Production facilities. We should clarify whether secondary containment is inapplicable for offshore and coastal production facilities, and therefore, whether the proposed integrity testing requirements are necessary at such facilities. "In all other cases," the integrity testing requirements should not be applicable to the production industry. (1199 (1993 commenter)) Small facilities. Supports testing requirements. "The testing of tanks for integrity is needed. While most large corporations perform testing at some frequency, most smaller businesses do not. Exemptions because of size or quantity of oil stored should not be granted because the smaller facilities generally are more in need of testing." (3, 4, 27, 95) Opposes testing requirements. "EPA should make a distinction between large and small facilities, and should require integrity testing only on larger tanks such as those commonly located at complicated fuel distribution sites, commonly known as tank farms. Facilities which are primarily engaged in vehicle refueling operate above ground tanks which typically hold significantly less than that found at tank farms are suitable for visual inspections. EPA should realize that presently, there exists a limited amount of organizations which perform integrity tests on above ground tanks. If EPA were to promulgate an integrity test requirement on all aboveground tanks, many trucking facilities will find it difficult and expensive to identify appropriate testing agents." (53, 70) Proposed §112.7( d) integrity testing requirements would be burdensome for small remote facilities. We should require integrity testing only at a facility with a storage capacity greater than 42,000 gallons and without the structures or equipment listed in proposed §112.7( c). (78, 145, L3) We should require integrity testing for facilities with a storage capacity greater than 100,000 gallons, and testing of valves and piping located directly above or on a pervious surface of such tanks. (90,1137 (1993 commenter)) The §112.7( d) requirement should apply only to tanks with more than 660 gallons, because the costs of integrity testing smaller tanks outweigh the benefits. (125) The §112.9( d) provisions provide adequate environmental protection for small facilities. (145) Tank failure. "Integrity testing at other than ten (10) year intervals should only be required if a tank failure has occurred within the last 5 years or the tank is 195 used to store materials that are corrosive to the tank material. The small tanks at E& P operations are not likely to be susceptible to conditions requiring the five year inspection regimen." (114) Underground cable systems. Current technology does not allow an owner or operator to apply the secondary containment, inspection, and integrity testing requirements of the SPCC program to underground cable systems. (92, 98, 125) Proposed §112.7( d) is inappropriate for underground cable systems because there is no efficient system for integrity testing miles of interconnected piping. An owner or operator must keep underground cable systems in service. It is impossible for an owner or operator to develop a site­ specific contingency plan for underground cable, since such systems cover large geographical areas. (125) We should not require an owner or operator to prepare a Plan for or integrity test cable systems. (164, 165) Unprotected underground piping. We should limit annual integrity and leak test requirements to unprotected underground piping. (167) Within structures, small tanks. "We propose an exemption for integrity testing of all tanks which: are contained within a building or have a maximum capacity of less than 2000 gallons; have all sides visible, and; which are visually inspected (along with any associated piping and ancillary equipment) at least monthly." (54, 71, 78, 90, 101, 109, 110, 162, 167, 175) Cost. Integrity testing is too costly. (28, 31, 54, 57, 58, 90, 102, 110; 1137,1145 (1993 commenters).) The proposed requirement to test tanks without secondary containment annually would be costly and would restrict the owner's or operator's ability to conduct necessary inventories and to "meet supply and demand needs." It would be impossible for the facility to operate if all tanks were taken out of service for testing every year. (25) We did not adequately consider the costs associated with the integrity testing for high pour point (e. g., 60 " F) bulk storage tanks, because proposed §112.7( d) would require an owner or operator to completely drain and clean a tank. Such integrity tests would pose an unnecessary cost given the low risk of spills from such tanks. (90) We did not consider the cost of integrity testing substations and other oil­ filled equipment in our economic impact analysis for the rulemaking. Such testing is impractical since owners or operators would have to test individual equipment pieces. (L2) Discretionary testing. We should allow an owner or operator to determine the integrity of aboveground piping through frequent visual inspection and observation of the product flowing through the line. We should allow an owner or operator to conduct visual inspections to comply with the §112.7( d) integrity testing requirement. (54) The requirement to conduct integrity testing applies to aboveground and buried tanks, piping, and valves should be discretionary. If the requirement were discretionary, the owner or operator could set a testing frequency based on facility­ specific factors such as the facility's age, soil corrosiveness, and corrosion protection. Such a discretionary 196 provision "defeats the discretionary metallic testing scheduled contained in §112. 8( c)( 4) for buried metallic tanks and §112. 8( d)( 4) for buried piping." (102) Frequency of testing. Support for proposal. General support for our proposal to specify time periods. (148, L1) Support for proposal to perform integrity testing of tanks once every five years at facilities without secondary containment. (95, 101, 102, L1, L2) Support for testing valves and piping once a year at such facilities. (80, 117) Support for integrity testing for cathodically protected piping every five years (167) and at the time of installation, modification, repair, and relocation (67). Opposition to proposal. We should not require integrity testing of tanks every five years. (57, 78, 90, 101, 109, 128, L2, (1137, 1145, 1146, 1199 (1993 commenters)) Imposing these specific time periods is unnecessary and would provide "no improvement in the quality of SPCC plans." (155) Cost. The proposed requirement to test tanks with secondary containment every five years would be costly and would obstruct handling necessary inventories. The proposed requirement would reduce the commenter's facility's ability to meet supply and demand, and it would be impossible to operate the facility if all tanks were out of service for testing every year. (25) Excessive. "This requirement is not realistic for the oil and gas industry in Appalachia. It is recommended that the current language from §112.7( e)( 5) be retained." (54, 67, 91, 95, 101, 102, 109, 167, 175, L2; (1137, 1145, 1146, 1199 (1993 commenters)). New tanks need less inspections than older ones, and we should only require an owner or operator to test a tank every five years after the first fifteen years of the tank's manufacturing date. (1165 (1993 commenter)) We should only require integrity testing less frequently than every 10 years only if a tank failure has occurred within the last five years, or if the tank contains corrosive materials. Small tanks at exploration and production (E& P) operation sites are unlikely to require integrity testing every five years. We should require integrity testing of pipes, valves, and fittings when corrosion or leakage has occurred or is "potentially severe." (114) We should only require an owner or operator to test valves and piping without secondary containment once every five years, and we should require an owner or operator to include in the Plan a schedule of visual inspections for such valves and piping. (95, L2) Such an approach would reduce the amount of waste generated by integrity testing and provide a reasonable integrity testing schedule. (95) Maintenance instead. Routine inspection and maintenance of aboveground storage tanks and associated pipes, valves, and pumps is sufficient to eliminate the potential of a significant spill. We should require integrity testing only when the owner or operator detects something that may lead to a discharge. Inspections allow an owner or operator to determine whether maintenance and 197 repairs are required to prevent a discharge. (54, 71, 78, 90, 101, 109, 110, 162, 167, 175) Material repairs. Integrity testing is necessary only after material repairs. (78) Mines. "For some small mining facilities, these testing requirements would be overly burdensome and quite expensive.... EPA should take into account the quantity of oil stored at a facility, and allow small facilities, with secondary containment, the right to inspect and monitor at the operator discretion, in accordance with good engineering practice." (10) Need for testing. We should develop an "administrative record" to determine the need for integrity testing. We should not require an integrity testing schedule in Phase One without stating what types of tests meet "statutory objectives." (75) Negative or no environmental impact. Integrity testing can negatively impact the environment. (90, 95) Annual testing would not significantly increase the level of environmental protection. (L2) System failures. Integrity testing may exacerbate the probability of system failures. (67, 91, 1146, 1155 (1993 commenters)) Tank construction. We should base the frequency of integrity testing on such factors as the tank construction material and the nature of the material in the tank. (190) Unnecessary. "This testing requirement would be costly to impose and lacks justification. Tanks with and without secondary containment deteriorate at the same rate and there is no reason to impose different testing requirements. The lack of secondary containment should be compensated for by site­ specific contingency plans." (57) Weekly inspections instead. Instead of requiring annual integrity and leak testing, we should allow an owner or operator to conduct weekly inspections for oil leaks or spills during normal production facility operating conditions. There is a low risk of significant spills at production facility oil gathering systems because individual wells are located in a central processing storage facility. (1145 (1993 comment)) More frequent testing. We should permit more frequent inspection and monitoring than the rule requires. (87) Guidance. We should set guidelines and recommendations in §112.7( d) for inspections and testing procedures and include proven and acceptable test methods in the regulation. We should include in §112.7( d) specific integrity testing procedures required for electrical equipment. (27, 80, L2) 198 Integrity testing. We should revise §112.7( d) to define integrity testing. (70) We did not define periodic integrity testing in the proposed rule, noting that we define the term in current §112.7( e)( 2)( vi). (1149 (1993 comment)) Methods of testing. Acoustic emission testing. We should allow for acoustic emission testing instead of hydrostatic testing as covered by API Standard 653. The tests are equally effective, but acoustic emission testing reduces wastewater production. (1135 (1993 comment)) API standards. "In lieu of frequent `integrity testing, ' we suggest that the EPA adopt the inspection portion of API 653, which allows up to 20 years between inspections. Integrity testing should be defined as the evaluation of a tank for serviceability. Short of a hydrostatic test, comprehensive tank inspection is the only method to evaluate the serviceability of a tank. The tank inspection method presented in API 653 details the tank components that should be examined and appropriate examination methods." (1145, 1149 (1993 commenters)) Hydrostatic testing. We should allow an owner or operator to supplement hydrostatic testing with other inspection techniques while the tanks are in service and not being tested. This would allow an owner or operator to schedule tank outages when it is most convenient. (25) "No appropriate technology." There is no appropriate technology for testing fiberglass tanks or aboveground storage tanks. (62) Pressure testing. Pressure testing could perforate a weakened section of piping, and compel an owner or operator to isolate and repair the section to avoid a corrosionrelated leak. A corrosion­ related leak could easily develop the day after the owner or operator performs pressure testing. (28, 31, 101, 165, L15) Frequent pressure testing of buried tanks and piping will create ­­ not prevent ­­ pollution, since owners or operators must conduct pressure testing with the oil contained in the system or must drain the oil and replace it with water. Pressure testing generates solid wastes, and that owners or operators must treat and dispose of the oily waste. (102) Pressure testing of tanks, valves, and equipment can weaken the integrity of a steel tank and contribute to failures of such tanks, valves, and equipment. (128) Reference to §112.7( c). Our cross­ reference to §112.7( c) is unclear. It is unclear whether the §112.7( c) reference refers to the existing or the proposed rule. Proposed §112.7( d) integrity testing requirement appears to refer only to tank batteries with dikes, berms, or retaining walls sufficiently impervious to contain spilled oil. (955 (1993 commenter)) Visual inspection. 199 Frequency. Weekly inspection. We should allow an owner or operator to conduct daily or weekly visual inspections of valves and pipes. (1145,1199 (1993 commenters)) Monthly inspection. We should require an owner or operator to conduct a visual inspection of valves and aboveground piping at least once a month. (67, 91, 167) Periodic inspection. "To require annual integrity and leak testing of aboveground piping and valves is unrealistic and could exacerbate the probability of or initiate system failures. The requirement should read "visually inspect valves and aboveground piping periodically and conduct an engineering evaluation of unprotected underground piping once every five years." (67, 101, 128, 167,175; 1146 (1993 commenter)). We should require periodic visual examinations similar to the examinations proposed under §112.9( e). (101) Internal and external inspection. We should clarify whether a visual inspection must be both internal and external. (76) Supplement to inspections. An owner or operator should supplement integrity testing with visual inspections (95, 102) and recordkeeping (128). We should supplement visual inspections of aboveground valves and piping with a five­ year integrity testing schedule. (175) Response: Support for proposal. We appreciate commenter support. Applicability. Integrity testing is essential for all aboveground containers to help prevent discharges. Testing will show whether corrosion has reached a point where repairs or replacement of the container is needed. Therefore, it must apply to large and small containers, containers on and off the ground wherever located, and to containers storing any type of oil. From all of these containers there exists the possibility of discharge. We agree that integrity testing of aboveground piping should be discretionary when the facility has secondary containment which would contain a discharge from such piping. Integrity and leak testing requirements are also applicable for containers and valves and piping that are entirely within buildings, or within mines, because in either case, such containers, or valves and piping may become the source of a discharge as described in §112.1( b). We have revised the rule to reflect that the requirement applies only to onshore and offshore bulk storage facilities. Therefore, a facility with only oil­ filled electrical, operating, or manufacturing equipment need not conduct such testing. We disagree that testing of valves, gathering lines, and flowlines would be prohibitively costly. In 1991, we estimated tank integrity testing and leak testing costs of buried piping. We estimated the costs as $465 per tank, $155 for equipment, and $310 for installation. Small facilities were assumed to have no buried piping. Medium sized facilities were assumed to bear first year costs for tank installation and testing of $4,704 and subsequent year costs of $1,449. Large facilities were assumed to incur a first year 200 cost of $11,313, and subsequent year costs of $3,519. We believe that this provision represents a negligible additional burden because most facilities are already testing such valves and gathering lines according to industry standards as a matter of good engineering practice. We believe that if such testing is done in accordance with industry standards, costs will be minimized because such standards will likely include options appropriate to the equipment tested at a reasonable cost. We decline to exclude from §112.7( d) all tanks that are less than 15 years old, since the corrosion and discharge rates of one container will differ from the next. We also decline to require integrity testing only when the owner or operator determines that there is a risk of discharge, since that standard is not objective. We also disagree that we should only require owners or operators to integrity test valves and piping when corrosion or leakage has occurred or is potentially severe because it is inappropriate to require a test only when the system or equipment shows signs of potential failure. The idea of testing is to prevent such corrosion or leakage. Likewise, a weekly inspection for leaks is not the equivalent of conducting integrity tests. Visual inspection must be combined with some other technique. Electrical equipment. Because electrical, operating, manufacturing equipment are not bulk storage containers, the requirement is inapplicable to those devices or equipment. 56 FR 54623. Also, as noted by commenters, methods may not exist for integrity testing of such devices or equipment. Fixed aboveground piping. Section 112.7( d) applies both to completely buried and aboveground tanks, valves, and piping, including gathering lines and flowlines. There is no conflict with either §112.8( c)( 4) or (d)( 4). Section 112.8( c)( 4) provides for "regular" testing of completely buried tanks. Section 112.8( d)( 4) provides for "regular" inspection of aboveground valves, piping, and appurtenances, and integrity and leak testing of buried piping at the time of installation, modification, construction, relocation, or replacement. Section 112.7( d) provides for "periodic" integrity testing, and "periodic" integrity and leak testing. Either "periodic" or "regular" testing should be conducted according to industry standards. Thus, there is no conflict between the rule provisions. Impracticality. Integrity testing under §112.7( d) must be performed if the facility lacks secondary containment. You have discretion as to the method of testing, but it must be performed if it is possible to do so. If it is impossible, then the owner or operator must explain his reasons for nonconformance with the requirement, and provide equivalent environmental protection by some other means. Phase­ in. We disagree that there should be a phase­ in period. We believe that the time allowed in §112.3 for Plan amendment and implementation allows ample time for both existing and future facilities to comply with the changes in the rule. 201 Underground cable systems. Because electrical, operating, manufacturing equipment are not bulk storage containers, the requirement is inapplicable to those devices or equipment. 56 FR 54623. Also, as noted by commenters, methods may not exist for integrity testing of such devices or equipment. Unprotected underground piping. We do not require periodic integrity testing for underground piping, since uncovering buried piping may present an undue hazard. Integrity and leak testing must be conducted when buried piping is installed, modified, constructed, relocated, or replaced. For comments on integrity testing requirements for cathodically protected piping and unprotected underground piping, see the comments on §112.8( c)( 4) and (d)( 1) in today's preamble. Costs. We disagree that integrity testing is too costly because industry standards will likely incorporate options appropriate to the equipment at reasonable cost. It may help save the owner or operator money by preventing a discharge as described in §112.1( b). In 1991, we estimated tank integrity testing and leak testing costs of buried piping. We estimated the costs as $465 per tank, equipment of $155, and installation costs of $310 per tank. Small facilities were assumed to have no buried piping. Medium sized facilities were assumed to bear first year costs for tank installation and testing of $4,704 and subsequent year costs of $1,449. Large facilities were assumed to incur a first year cost of $11,313, and subsequent year costs of $3,519. We assume that this provision represents a negligible additional burden because most facilities are already testing such valves and gathering lines according to industry standards as a matter of good engineering practice. Frequency of testing. We have modified our proposal in response to comments. We require such testing on a periodic basis instead of at a prescribed frequency, both for containers and for valves and piping. "Periodic" testing means testing according to a regular schedule consistent with accepted industry standards. We believe that use of industry standards, which change over time, will prove more feasible than providing a specific and unchanging regulatory requirement. As required by §112.8( c)( 6), integrity testing of containers must be accomplished by a combination of visual testing and some other technique. We disagree that required integrity testing may force an owner or operator to shut down the facility or its systems. Because such testing is performed on a periodic or scheduled basis, the owner or operator has discretion as to the schedule to keep the facility open as much as possible. Integrity and leak testing. In response to a commenter who asked for a clarification of integrity testing, "integrity testing" is any means to measure the strength (structural soundness) of the container shell, bottom, and/ or floor to contain oil and may include leak testing to determine whether the container will discharge oil. Facility components that might cause a discharge as described in §112.1( b) include containers, piping, valves, or other equipment or devices. Integrity testing includes, but is not limited to, 202 testing foundations and supports of containers. Its scope includes both the inside and outside of the container. It also includes frequent observation of the outside of the container for signs of deterioration, leaks, or accumulation of oil inside diked areas. Such testing is also applicable to valves and piping. See API Standard 653 for further information on this term. Leak testing for purposes of the rule is testing to determine the liquid tightness of valves and piping and whether they may discharge oil. Facilities that store oil, whether they are mines or other businesses, are required to employ integrity testing for their bulk storage containers, and integrity and leak testing for their valves and piping, to help prevent discharges. Containers that do not store oil, but merely use oil, are not subject to the requirement. Methods of testing. We do not prescribe the method of testing, except to require that visual inspection must be combined with some other technique. We agree that an owner or operator may supplement hydrostatic testing with other inspection techniques while the tanks are in service and not being tested. We disagree that visual inspection and nondestructive shell thickness testing are insufficient. Such testing should give the owner or operator an indication of the container's integrity. We disagree that an "engineering evaluation" of unprotected, underground piping is acceptable in lieu of an integrity and leak test because such evaluation may not provide equivalent environmental protection as integrity and leak testing of valves and piping. Likewise, a "routine inspection" of flowlines does not rise to the level of integrity and leak testing. We disagree that integrity testing would require an owner or operator to completely drain and clean high pour point bulk storage containers. Testing may be possible without such drainage, either by using a particular method, for example, a robot, or performing such testing during regularly scheduled maintenance. We also disagree that integrity testing will exacerbate the probability of system failures or negatively impact the environment. Integrity testing is a non­ destructive type of testing that should not affect system failures. Its only effect on the environment should be a positive one, to help prevent a discharge as described in §112.1( b). An owner or operator must consider the tank design and its construction material when determining an appropriate testing schedule and method, and may determine a periodic testing schedule and method based on good engineering practice, relevant industry standards, and optimal use of facility resources. The owner or operator must also consider factors such as the potential for tank failure, tank design, and tank material when determining an appropriate testing schedule and method. Among these factors should be how the material stored effects the structural integrity of the tank. We disagree with the commenter who stated that integrity testing is necessary only after 203 material repairs. A discharge may occur at any time, regardless of whether an owner or operator has conducted repairs. Guidance. Due to rapidly changing technology, we cannot list all types of integrity testing methods. There is no single operational standard we can prescribe for all non­ transportation­ related facilities. However, we include industry standards in the preamble to today's final rule to assist the reader. See the discussion in §§ 112.7( d) and 112.8( c)( 6). We also list organizations that help to formulate industry standards in section IV. D of today's preamble. Pressure testing. We do not require pressure testing. Therefore, none of the problems cited with such testing are relevant. Reference to §112.7( c). The reference in proposed §112.7( d) was to proposed §112.7( c). Section §112.7( d) integrity testing and integrity and leak testing requirements apply to any facility which lacks secondary containment. Visual inspection. The rule requires visual testing in conjunction with another method of testing, because visual testing alone is normally insufficient to measure the integrity of a container. Visual testing alone might not detect problems which could lead to container failure. For example, studies of the 1988 Ashland oil spill suggest that the tank collapse resulted from a brittle fracture in the shell of the tank. Adequate fracture toughness of the base metal of existing tanks is an important consideration in discharge prevention, especially in cold weather. Although no definitive non­ destructive test exists for testing fracture toughness, had the tank been evaluated for brittle fracture, for example under API standard 653, and had the evaluation shown that the tank was at risk for brittle fracture, the owner or operator could have taken measures to repair or modify the tank's operation to prevent failure. For certain smaller shop­ built containers in which internal corrosion poses minimal risk of failure; which are inspected at least monthly; and, for which all sides are visible (i. e., the container has no contact with the ground), visual inspection alone might suffice, subject to good engineering practice. In such case the owner or operator must explain in the Plan why visual integrity testing alone is sufficient, and provide equivalent environmental protection. 40 CFR 112.7( a)( 2). However, containers which are in contact with the ground must be evaluated for integrity in accordance with industry standards and good engineering practice. X ­ G: Inspections, tests, and records ­ §112.7( e) Background: Under §112.7( e)( 8) of the current rule, an owner or operator must maintain inspection records as part of an SPCC Plan for three years. In §112.7( e) of the 1991 proposed rule, we proposed to extend the period for retaining records of inspections, test results, and written procedures from three to five years. We proposed this extension to be consistent with the Federal statute of limitations on assessing civil penalties for violating the SPCC rule. We also proposed that these records be 204 maintained with an SPCC Plan, and not as part of an SPCC Plan. In 1997, we proposed to retain the three­ year record retention standard. Comments: Editorial suggestion. In the first sentence of §112.7( e), we should change the word shall to must. (121) Form of records. "... written procedures for testing only should be omitted from the proposed rule." Believes that "written procedures for testing can be quite lengthy and would have meaning to the tester only." (37) 40 CFR part 112 should include the testing required by 40 CFR part 280. (47) Date. Each inspection and test report should be dated. (47) Electronic format. "Using electronic media for the storage and retrieval of standard operating practices, inspection protocols, testing procedures, and maintenance records is becoming commonplace in industry. BP requests that language be inserted in this section to allow the use of computers or other electronic devices for the purpose of satisfying this section." (96) Repairs and training. In §112.7( e), we should require owners or operators to keep records and tests of all major repairs and of employee training, in addition to written procedures and records of inspections and tests. (147) Maintenance with Plan. Accessible location. "FINA proposes that the records be maintained at the facility or at an alternate location accessible within 24 hours." (25, 37, 38, 47, 67, 83, 187) Principal place of business. Owners or operators should maintain records for the most current three years with the Plan, and should maintain records for the remaining two years at the facility's principal place of business. (54) Required inspections and tests. "It would be helpful if EPA could include a list of all inspections and tests required by this part." (16) Time period. Opposes 5­ year proposal. (22, 33, 67, 101, 113, 167, 181, 187) An obligation to maintain records for five years places an undue administrative burden on facility owners or operators. (45, 113, 181) A five­ year record retention provision is inconsistent with other environmental protection regulations. (See, for example, Resource Conservation and Recovery Act regulations, 40 CFR parts 264 and 265, and Department of Transportation requirements.) (35, 78, 109, 153) We should require owners or operators to retain records in accordance with other 205 State and Federal agency requirements to avoid additional and unnecessary costs. (114) 2 years. We should reduce the record retention period to two years. (45) Phase­ in. "API suggests that in order to be consistent with record retention requirements under the NPDES program of the CWA, records should only be retained for three years. However, if the Agency insists on a new five year requirement, because the required records have only been maintained for three years consistent with the current regulation, there will be a need for at least a phase­ in period to bring those records which were retained into compliance with this new provision." (67, 79, 95, 101, 102) 3 years. Retaining records for three years should be adequate, since we require the review and recertification of an SPCC Plan every three years. (66) Small facilities. Opposes requirement. The proposed requirement to maintain records with the SPCC Plan for five years would be particularly burdensome for small facilities. (28, 58, 62, 101) Proposed §112.7( e) is only appropriate for large facilities. (192) Favors requirement. Maintaining records with the Plan should only apply to small facilities. (9, 77) Response: Editorial suggestion. In response to the comment that we change shall to must in §112.7( e), we agree, and have made that change throughout the rule to further our plain language objectives. Form of records. Records of inspections and tests required by this rule may be maintained in electronic or any other format which is readily accessible to the facility and to EPA personnel. Whatever format you use, however, must be readily accessible to response personnel in an emergency. If such records are produced in a medium that is not readily accessible in an emergency, they must also be available in a medium that is. For example, records might be electronically produced, but computers fail and may not be operable in an emergency. For electronic records, or records produced in another medium, therefore, backup copies must be readily available on paper. At least one version of the records should be written in English so that they will be readily understood by an EPA inspector. Usual and customary business records may be those ordinarily used in the industry, including those made under API standards, Underwriters' Laboratories standards, NPDES permits, a facility's Q. S.­ 9000 or ISO­ 14000 system, or any other format acceptable to the Regional Administrator. If you choose to use records associated with compliance with industry standards, such as Underwriters' Laboratories standards, you 206 must closely review the inspection, testing, and record keeping requirements of this rule to ensure that any records kept in accordance with industry standards meets the intent of the rule. Some standards have limited record keeping requirements and may only address a particular aspect of container fabrication, installation, inspection, and operation and maintenance. The intent of the rule is that you will not have to maintain duplicate sets of records when one set has already been prepared under industry or regulatory purposes that also fully suffices for SPCC purposes. The use of these alternative record formats is optional; you are not required to use them, but you may use them. We disagree that we should omit written procedures for testing. Such procedures are essential for implementation of testing and inspection requirements, and must be described in the Plan. We disagree that we should include the testing requirements of 40 CFR part 280 in the rule, however, such procedures may be applicable, subject to good engineering practice. Date. Dated records are essential to document compliance with both substantive and recordkeeping requirements. Dated records are also consistent with usual and customary business practices. Maintenance with Plan. We agree with commenters that it is not necessary to maintain records as part of the Plan. Therefore, today's rule allows "keeping" of the records "with" the Plan, but not as part of it. In the current rule, such records "should be made part of the SPCC Plan...." 40 CFR 112.7( e)( 8). Because you continually update these records, this change will eliminate the need to amend your Plan each time you remove old records and add new ones. You still retain the option of making these records a part of the Plan if you choose. Records required. The rule permits use of usual and customary business records, and covers all of the inspections and tests required by this part as well as any ancillary records. "Inspections and tests" include not only inspections and tests, but schedules, evaluations, examinations, descriptions, and similar activities required by this part. Required inspections and tests. After publication of this rule, we will list all of the inspections and tests required by part 112 on our website (www. epa. gov/ oilspill). The applicability of each inspection and test will depend on the exercise of good engineering practice, because not every one will be applicable to every facility. Time period. We agree with commenters that maintenance of records for three years is sufficient for SPCC purposes, since that period will allow for meaningful comparisons of inspections and tests taken. Therefore, there will also be no new costs. We note, however, that certain industry standards, for example API Standards 570 and 653, may specify record maintenance for more than three years. 207 We disagree that we should require record retention in accordance with State and other Federal requirements. State and Federal record retention requirements vary, making it difficult to establish a single standard. X ­ H: Training ­ §112.7( f) Background: Section 112.7( e)( 10) in the current rule prescribes the employee training requirements and discharge prevention procedures that a facility owner or operator must observe. It provides that owners or operators are responsible for properly instructing personnel, and scheduling and conducting spill prevention briefings at intervals frequent enough to assure adequate understanding of the SPCC Plan. In 1991, we redesignated §112.7( e)( 10) as §112.7( f), and proposed to require: (1) an owner or operator to conduct training exercises at least annually for all personnel, and train new employees within their first week of work; and, (2) an owner or operator to schedule and conduct spill prevention briefings at least once a year. We also proposed specific training subjects for inclusion in the training program. Comments: Support for proposal. "Shell agrees with this proposal and has been conducting such retaining at their facilities." (10, 27, 96, 143, 147, 185) Applicability. Bulk storage. We should require staff training for major bulk terminal and tank farm facilities. (192) Existing programs. Facilities should be allowed to incorporate SPCC training provisions into already existing training programs required by other Federal or State regulations. (91, 96, 162) Operation and maintenance of equipment. "The rule should only apply to `personnel involved in oil transfer operations, emergency response, and countermeasure activities." It should not apply to clerks, secretaries, and like employees. (14, 35, 42, 45, 48, 57, 62, 66, 67, 71, 77, 88, 92, 98, 103, 115, 117, 125, 141, 164, 167, 173, 175, 180, 181, 182, 187, 189, L7, L12, L18, L24) Small facilities. We should provide for a small facility exemption. (79, 109, 175, 180, 182) Content of training. Training should address the initial response to a spill, such as emergency notification and implementation of emergency containment measures. Exercises of these emergency plans should be conducted at least annually. (1) Objects to the proposal that employees be trained in maintenance of oil storage equipment or oil transfer procedures. (42, 125) Discharge prevention briefings. "API suggests that section 112.7( f)( 3) be amended to require `briefings for operating personnel at least once a year ... to assure understanding 208 of the SPCC plan for that facility in conjunction with the annual training. ' This paragraph should also require briefings of `new operational employees during their indoctrination with their job responsibilities, and as appropriate for all affected operational personnel when changes are made to the existing Plan necessitating recertification." (67) Favors the present requirement to hold spill prevention briefings "at intervals frequent enough to assure adequate understanding of the SPCC Plan." (78) Documentation. The rule should include a provision that owners or operators document each training session and spill response drill conducted, and maintain training session and drill records for five years. (47, 96) Editorial suggestion. We should clarify proposed §112.7( f), in which we continue to use the word should. The commenter suggested that we replace should with either shall or "it is recommended" to avoid confusion. (16) Timing of employee training. Support for annual training requirement. We should allow owners or operators to coordinate SPCC Plan training with local oil spill response organizations or Local Emergency Planning Committees (LEPCs) whenever possible. (27) Favors proposed provision for annual training exercises. (27, 34, 141) Opposition to prescribed training periods. We should avoid requiring a period for conducting training exercises. (62, 66, 71, 109, 113, 128) Drills. The annual training should not be considered a full­ scale SPCC drill. (L3) New employees. We should define the phrase new employee. (103) Others oppose the provision to train new employees within one week of employment, arguing that such a provision is impractical, and called for employer discretion in scheduling training. Some suggested varying time periods in lieu of one week. Those suggestions ranged from one month to one year, with alternatives suggested such as "as soon as practical," "prior to operation but before one year," "within one week of job assignment," "a more reasonable time period," "after training," and "until the next annual training for all employees." (5, 28, 31, 34, 35, 36, 38, 55, 57, 62, 66, 67, 70, 71, 77, 79, 87, 89, 90, 92, 93, 96, 98, 101, 103, 113, 114, 115, 117, 118, 125, 128, 133, 141, 145, 155, 158, 162, 164, 173, 182, 187, 189, L6, L7, L14, L29) Response: Support for proposal. We appreciate commenter support. Applicability. We believe that training requirements should apply to all facilities, large or small, including all those that store or use oil, regardless of the amount of oil transferred in any particular time. Training may help avert human error, which is a principal cause of oil discharges. "Spills from ASTs may occur as a result of operator error, for example, during loading operations (e. g., vessel or tank truck ­ AST transfer operation), 209 or as a result of structural failure (e. g., brittle fracture) because of inadequate maintenance of the AST." EPA Liner Study at 14. The 1995 SPCC Survey found that operator error was the most common spill cause for facilities in 9 of the 19 industry categories that reported having spills. Also, the August 1994 draft report of the Aboveground Oil Storage Facilities Workgroup called "Soil and Ground Water Contamination from Aboveground Oil Storage Facilities: A Strategic Study" presented data on causes of discharges from two studies. Both studies showed that error during product transfer activities is one of the biggest known causes of discharges at AST facilities. Two other studies also support our contention: Carter, W. J., "How API Viewed the Needs for Aboveground Storage Tanks," Tank Talk, Vol. 7, July/ August 1992, p. 2.; and U. S. EPA, "The Technical Background Document to Support the Implementation of OPA Response Plan Requirements," Emergency Response Division, Office of Solid Waste and Emergency Response, February 1993, p. 4­ 19. We have therefore retained the applicability of training to all facilities. The 1993 proposal would have limited training requirements to only certain facilities which received or transferred over the proposed amount of oil. Facilities which receive or transfer less than the proposed amount might also have discharges which could have been averted through required training. Also the proposed rule would have exempted many facilities that use rather than store oil from its scope. Therefore, we have provided in the rule that all facilities, whether bulk storage facilities or facilities that merely use oil, must train oilhandling employees because all facilities have the potential for a discharge as described in §112.1( b), and training is necessary to avert such a discharge. We agree with the commenter that training is only necessary for personnel who will use it to carry out the requirements of this rule. Therefore revised paragraph (f)( 1) provides that only oil­ handling personnel are subject to training requirements, as we proposed in 1993. "Oil­ handling personnel" is to be interpreted according to industry standards, but includes employees engaged in the operation and maintenance of oil storage containers or the operation of equipment related to storage containers and emergency response personnel. We do not interpret the term to include secretaries, clerks, and other personnel who are never involved in operation or maintenance activities related to oil storage or equipment, oil transfer operations, emergency response, countermeasure functions, or similar activities. Existing programs. You may incorporate SPCC training requirements into already existing training programs required by other Federal or State law at your option or may conduct SPCC training separately. You may coordinate such training with training on other subjects, or with other agencies like LEPCs or oil spill response organizations. Content of training. Specifying a minimum list of training subjects is necessary to ensure that facility employees are aware of discharge prevention procedures and regulations. As suggested by a commenter, we have added knowledge of discharge procedure protocols to the list of training subjects because such training will help avert discharges. Therefore, we have specified that training must include, at a minimum: the operation and maintenance of equipment to prevent the discharge of oil; discharge 210 procedure protocols; applicable pollution control laws, rules, and regulations; general facility operations; and, the contents of the facility Plan. As noted above, we require response training for facilities that must submit response plans, but such training is not necessary for all SPCC facilities. In response to the utility commenter who asserted that utility employees do not need to be trained in the maintenance of oil storage tanks because such maintenance does not involve the transfer and handling of oil, we note that training must address relevant maintenance activities at the facility. If there is no transfer and handling of oil, such topic need not be covered in training. Discharge prevention briefings. Annual discharge prevention briefings are necessary, but there should be more frequent briefings where appropriate. Such briefings are necessary to refresh employees' memories on facility Plan provisions and to update employees on the latest prevention and response techniques. Training must include the contents of the facility Plan. Although it is desirable, we disagree that we should require SPCC briefings to include emergency response training. That training is already required for those facilities which must prepare response plans. Documentation. You must document that you have conducted required training courses. Such documentation must be maintained with the Plan for three years. Editorial suggestion. We agree with the commenter, and have made the editorial change from "should" to "must" for all requirements. We have eliminated all recommendations from the rule to avoid confusing the regulated public with what is mandatory and what is discretionary. Therefore, no shoulds remain in the rule. Timing of employee training. We agree with commenters who thought it desirable to leave the timing and number of hours of training of oil­ handling employees, including new employees, to the employer's discretion. "Proper instruction" of oil­ handling employees, as required in the rule, means in accordance with industry standards or at a frequency sufficient to prevent a discharge as described in §112.1( b). This standard will allow facilities more flexibility to develop training programs better suited to the particular facility. While the rule requires annual discharge prevention briefings, we also agree that the annual briefings required are not drills. In any case, the SPCC rules do not require drills, as explained below. For purposes of the rule, it is not necessary to define a "new employee" because all oilhandling personnel are subject to training requirements, whether new or not. You do, however, have discretion as to the timing of that training, so long as the timing meets the requirements of good engineering practice. Unannounced drills. The proposed yearly frequency for unannounced drills is also unnecessary because such drills are already required at FRP facilities, which are higher risk facilities. We do not believe that the risk at all SPCC 211 facilities approaches the same level as at FRP facilities. Therefore, we are not finalizing this proposal, and there are no new costs. X ­ I: Security (excluding oil production facilities) ­ §112.7( g) Background: Since vandalism is a factor in many spills, we proposed in 1991, to modify the provisions for adequate and effective security. We also proposed to redesignate §112.7( e)( 9) as §112.7( g). These provisions would prevent facility access by unauthorized persons and prevent tampering with equipment and tanks. We proposed in §112.7( g)( 1) to recommend ­ not require ­ that owners or operators fully fence all plants handling, processing, or storing oil, and ensure that gates are locked or guarded when the facility is not in production or is unattended. In §112.7( g)( 2), we proposed to clarify that under current §112.7( e)( 9)( ii), an owner or operator must have adequate security to ensure that valves remain in the closed position when in non­ operating or non­ standby status. These valves include master flow and drain valves and any other valves that permit direct outward flow of the tank's contents to the surface. This proposal would allow owners or operators more flexibility in choosing a method of securing the valves, because the current rule requires the valves to be locked. We proposed editorial changes in redesignated §112.7( g)( 3) (currently §112.7( e)( 9)( iii)) to require that an owner or operator lock the starter control on all pumps in the "off" position. When the pumps are in a non­ operating or non­ standby status, the owner or operator would have to locate the starter control at a site accessible only to authorized personnel. Proposed §112.7( g)( 4) (currently §112.7( e)( 9)( iv)) would require an owner or operator to ensure that oil pipeline loading and unloading connections are securely capped or blank­ flanged when not in service or standby service for an extended time. We proposed to clarify that "an extended time" is six months or more. We proposed to recommend in redesignated §112.7( g)( 5) (currently §112.7( e)( 9)( v)) that facility lighting be commensurate with the facility type and location. Comments: Support for proposal. Favors recommendations for establishing security at a facility. (143) Opposition to proposal. We should tailor security requirements to specific facility needs. The PE and any responsible company official should determine the security requirements. (162) Applicability. Mobile facilities. "Mobile facilities should be exempt from the requirements as well. When in operation they are manned 24 hours per day. In addition, the 212 physical requirements such as landing, loading and unloading connections are not applicable to a mobile facility." (128) Editorial suggestion. We should define the term "plant." Security options often are limited for facilities located in residential areas. (37) Fences. Recommendation. We should recommend that owners or operators fully fence plants with a chain link fence with barbed wire ­ an adequate system for deterring vandalism. (16) Supports §112.7( g)( 1) recommendation to fence a facility, since owners or operators need discretion not to fence where it is impracticable or undesirable. (57) Requirement. We should change the proposed §112.7( g)( 1) recommendation to a requirement or delete it. (121) Loading/ unloading connections. "Larger facilities often have seasonal or contractual variations in the use of lines, pumps, racks and connections. Therefore, it would be costly and impractical to blank off lines only to reopen them in the seventh month. At such facilities, an unused tank would be closed but the piping would remain open. Accordingly, the regulation should recognize normal operating procedures at some facilities and provide operating flexibility while maintaining the necessary security." (54) We should specify that "securely capped" connections include quick­ disconnect fittings. (92) We should clarify that the second sentence in §112.7( g)( 4) regarding the loading and unloading connection provision included piping emptied of liquid content either by draining or by inert gas pressure. (121) Supports proposal that "an extended time" means more than six months. (147) Starter controls on pumps. "IFTOA recommends that EPA modify the requirement so that it would apply to facilities, not pumps, that have been closed for six months or more and the rule should be amended to read `locked in the `off' position or electronically disconnected. ' Disconnection, of course, serves the same purpose and frequently is much easier to control." (54) "There is no need for the double security being proposed with the word `and' instead of `or' in the aforementioned requirement. Such double security offers no additional benefit to deter vandals or other unauthorized persons." (67, 79, 85, 95, 102) "At a large facility, such a security requirement becomes unwieldy. The potential for losing keys or having the locks become inoperative due to freezing conditions is great." (88) We should state that pumps must be locked in the" off" position. (121) Response: Support for proposal. We appreciate commenter support. Applicability of requirements. We asked in the 1991 preamble (at 56 FR 54616) for comments as to whether provisions proposed as discretionary measures or recommendations should be made requirements. We were concerned whether these 213 proposed measures represented good engineering practice for all facilities. Specific comments are discussed below. In the case of proposed §112.7( g)( 1) and (5) as requirements, we have decided to retain the requirements as requirements rather than convert those paragraphs into recommendations as proposed. We have done this because we believe that fencing, facility lighting, and the other measures prescribed in the rule to prevent vandalism are elements of good engineering practice in most facilities, including mobile facilities. Where they are not a part of good engineering practice, we have amended the proposed provision allowing deviations, §112.7( a)( 2), to include the provisions in §112.7( g). Editorial suggestion. We agree that the term "plant" has no clear meaning. Therefore, in paragraph (g)( 1), we have substituted the term "facility" in its place, which is a defined term in these rules. Fences. Fencing helps to deter vandals and thus prevent the discharges that they might cause. In response to the commenter who argued that fences should be topped with barbed wire, or otherwise designed to deter vandalism, we agree. When you use a fence to protect a facility, the design of the fence should deter vandalism. Methods of deterring vandals might include barbed wire or other devices. If any type of fence is impractical, you may, under §112.7( a)( 2), explain your reasons for nonconformance and provide equivalent environmental protection by some other means. Loading/ unloading connections. In response to comment, we have decided to retain the current time line in §112.7( g)( 4), i. e., "an extended time," instead of specifying a sixmonth time line, due to the need for operational flexibility at facilities. We define "an extended time" in reference to industry standards or, in the absence of such standards, at a frequency sufficient to prevent any discharge. The appropriate method of securing or blank flanging of these connections is a matter of good engineering practice, and might include "quick disconnect fittings" as a possible deviation under §112.7( a)( 2). In any case, a secure cap is one equipped with some kind of lock or secure closure device to prevent vandalism. We disagree that the requirements of this paragraph should apply to the owner or operator of a facility instead of the owner or operator of the piping because a facility might place only some piping out of service for a period of time, and let other piping remain in service. Therefore, the owners or operators of some piping might escape the requirements of the rule and be more likely to discharge oil. We disagree that this requirement is costly or impractical. The requirement may save money by preventing costly discharges and cleanups. Regarding making the §112.7( g)( 4) requirements apply to facilities (not piping), we decline to make this change because facilities in service often place some, but not all, of the piping out­ of­ service for some period. The current requirement covers any piping out­ of­ service for an extended time, regardless of whether the facility is in service. In response to comment, we note that paragraph (g)( 4) applies to piping emptied of liquid content either by draining or by inert gas pressure. 214 Starter controls on pumps. We disagree that the requirements to have the starter control locked in the off position and be accessible only to authorized personnel are redundant. Restricting access to such pumps prevents unauthorized personnel from accidentally opening the starter control. These measures are necessary to prevent discharges at small as well as large facilities because the threat of discharge is the same regardless of the size of the container, and a small discharge may be harmful to the environment. If the potential for losing keys, weather conditions such as frequent freezing, or other engineering factors render such a measure infeasible, you may use the deviation provisions in §112.7( a)( 2) if you can explain your reasons for nonconformance and provide equivalent environmental protection by some other means. A facility may have some, but not all, pumps out­ of­ service for various periods ­ even during facility operations. We decline to exempt pumps which are out­ of­ service for six months or more because it would reduce the effectiveness of this preventive measure by leaving some piping unprotected for up to half a year. Valves. Revised §112.7( g)( 2) requires you to ensure that the master flow and drain valves and other valves permitting outward flow of the container's contents have adequate security measures. The current rule requires that such valves be securely locked in the closed position when in non­ operating or non­ standby status. Today's revised rule allows security measures other than locking drain valves or other valves permitting outflow to the surface. Manual locks may be preferable for valves that are not electronically or automatically controlled. Such locks may be the only practical way to ensure that valves stay in the closed position. For electronically controlled or automated systems, no manual lock may be necessary. The rule gives you discretion in the method of securing valves. We believe that this flexibility is necessary due to changes in technology and in the use of manual and electronic valving. X ­ J: Facility tank car and tank truck loading/ unloading racks ­ §112.7( h) Background: Section 112.7( e)( 4) of the current rule describes the precautionary measures an owner or operator must undertake in tank car and tank truck loading/ unloading racks to prevent discharges during transfers. Section §112.7( e)( 4)( i) requires that tank car and tank truck loading and unloading procedures meet the Department of Transportation's (DOT) minimum requirements and regulations. Section 112.7( e)( 4)( ii) requires that, where rack area drainage does not flow into a catchment basin or treatment facility designed to handle spills, an owner or operator must use a quick drainage system. Further, the containment system must be able to hold at least the maximum capacity of any single compartment of a tank car or tank truck loaded or unloaded at the plant. Under §112.7( e)( 4)( iii), an owner or operator must use an interlocked warning light, physical barrier system, or warning signs in loading/ unloading areas to prevent vehicular departure before complete disconnect. Section 112.7( e)( 4)( iv) of the current rule describes the examination and maintenance requirements that must be completed prior to filling and departure. 215 In 1991, we reproposed current §112.7( e)( 4), with a few changes. In §112.7( h)( 1), we proposed language requiring that tank truck loading/ unloading procedures meet the minimum requirements and regulations established by State and Federal law, in place of the current requirement that these procedures comply with DOT requirements and regulations. Comments: Alarm or warning systems. EPA should consider "adding the additional requirement that wheel chocks be used during all tank truck transfers "to guarantee that tank trucks will not roll unexpectedly while the loading arm is attached and the driver is out of the cab." (16) We should revise §112.7( h)( 3) to include additional industry standard equipment, and read as follows: "( 3) An interlocked warning light or physical barrier system, vehicle brake interlock system, or warning signs, or a system substantially similar in effectiveness shall be provided . . ." (83) Applicability. Asks us to clarify which types of facilities are subject to these provisions. (79) Asks whether this section applies only to facilities "routinely used for loading or unloading of tanker trucks from or into aboveground bulk storage tanks" or to any loading or unloading operation. (125) Phase­ in. We should allow facility owners or operators at least two years to comply with the requirements of this section. (71) We should provide more than 60 days from the date we promulgate the final rule. (125) Production facilities. "We believe that EPA should clarify that the provisions of this section do not apply to crude oil transfers from production fields into tank trucks. Adequate protection from the small drips that may occur from transferring crude to a tank truck is provided by a small sump or catchment basin." (75, 145, 167) Small facilities. We should exempt small oil production facilities. (28, 79, 175) We should exempt small aboveground tanks containing 1,000 barrels or less of oil. A portable drip plan has been sufficient for the degree of spill risk at such facilities. (67, 91, 101) Onshore production facilities should be exempted because they are small and have a negligible spill history. (167) Warning system. Asks whether the interlocking warning system requirement applies to tank batteries, plants, or both. (28, 101) Cost. Most Appalachian oil production operations would have to newly install the secondary containment system required under this section. Asks whether we factored the economic impact of installing such containment into the fiscal impact of the proposed rule. (28, 31, 113, 165, 187, L15) Editorial suggestions. We should replace loading/ unloading rack with loading/ unloading area in the section title to clarify that the provisions apply to all types of loading/ unloading stations. (47) We should define facility tank car and tank truck 216 loading/ unloading racks to clarify the type of facility to which this provision applies. (58, 79) We should move all of §112.7( h) to §112.8. (121) Other State or Federal law. "While SPCC facilities are subject to such requirements in addition to the SPCC rules, failure to meet such other requirements should not constitute a violation of the SPCC rules." (67) We should remove the reference to other state and federal law from the rule. (121) "The Company feels that proposed §112.7( h) should be eliminated. ... These are Department of Transportation items and should be covered by that Department's rules governing loading, unloading, and vehicle inspection. The compliance onus should be on the transporter." (164) Secondary containment. Support. Some degree of secondary containment is necessary during truck loading, but questions the need for such a large catchment system. (187) Contingency plan instead. We should allow a strong contingency plan in place of secondary containment. (28, 31, 101, 165, L15) Methods. We should clarify whether the use of any of the discharge prevention systems in §112.7( c) would satisfy §112.7( h)( 1) that the containment system be designed "to hold at least the maximum capacity of any single compartment of a tank car or tank truck loaded or unloaded in the plant." (115) Quick drainage system. We should define the term quick drainage system. Asks whether there are other acceptable ways to comply with this regulation (e. g., blocking nearby storm drains). (29) Recommends that we allow owners or operators to use the drainage control structures/ equipment listed in §112.7( c) in place of the quick drainage system. (124) Completely buried tanks. "The Ohio Utilities request U. S. EPA interpretation on whether such requirement applies solely to aboveground tank loading and unloading areas, or whether it would also apply to underground storage tank loading and unloading areas as well. If this provision attempts to regulate underground storage tanks loading and unloading areas, the Ohio Utilities strongly believe that such attempted regulation is inappropriate and would result in a multiplicity of regulation since the federal underground storage tank regulations, 40 CFR part 280, already regulate, to some extent, the loading and unloading procedures of underground storage tanks." (189) Response personnel instead. "Because many tank car loading/ unloading facilities are located on railroad property, or modifications that could undermine the railway bed are subject to railroad approval, providing containment for railcars is typically not feasible. ... Operators should have the option of providing for response personnel to be placed on alert when such an activity is to take place, and, where site conditions allow, provide a capture plan similar to, but more 217 limited in scope, than a full contingency plan. This would encourage secondary containment for storage tanks and other potential sources." (76) Unnecessary, procedures instead. "GM believes that mandatory tank car loading and unloading containment systems designed to hold at least the maximum capacity of any single compartment of a tank car or tank truck is unnecessary and costly. The cost to renovate existing loading and unloading areas at large manufacturing facilities is substantial and may have negligible environmental benefit if a spill does not occur or if the spill is not the entire contents of the tanker. ... GM recommends that in lieu of mandatory containment of the entire contents of the largest compartment of the tanker, an owner be allowed to demonstrate that procedures are in place to ensure that personnel are present at all times to supervise tank truck loading and unloading." (90) Vehicle drain closure. "Accordingly, EPA should delete that portion of proposed section 112.7( h)( 4) relating to examination and repair of trucks from the final rule. First, in most cases the trucks that pull up under a terminal's rack do not belong to the owner or operator of the facility. They are the property of petroleum marketers who are independent from the facility owner or operator. ... Second, facility employees are not trained or capable of properly examining and repairing trucks to prevent leakage, and such an obligation certainly could result in a major safety problem. Third, many facilities are completely automated or automated during certain periods of time during the day or night; there is no one at the facility. Thus, the requirement would prevent the operation of terminals at these times and would substantially disrupt the petroleum distribution system nationwide. Fourth, the Department of Transportation imposes the responsibility for maintenance and repair of motor vehicles on the owner or operator of the vehicle, the individual who controls the vehicle. EPA should adopt the same policy." (54, 115) Response: Alarm or warning systems. The requirement to provide a warning light or other physical barrier system applies to the loading/ unloading areas of facilities. We have amended the rule on the suggestion of a commenter to include "vehicle brake interlock system or other system substantially similar in effectiveness," and "wheel chocks." The examples listed in the rule of potential warning systems are merely illustrative. Any other alarm or warning system which serves the same purpose and performs effectively will also suffice to meet this requirement. Applicability. This section is applicable to any non­ transportation­ related or terminal facility where oil is loaded or unloaded from or to a tank car or tank truck. It applies to containers which are aboveground (including partially buried tanks, bunkered tanks, or vaulted tanks) or completely buried (except those exempted by this rule), and to all facilities, large or small. All of these facilities have a risk of discharge from transfers. Our Survey of Oil Storage Facilities (published in July 1996) showed that as annual throughput increases, so does the propensity to discharge, the severity of the discharge, and, to a lesser extent, the costs of the cleanup. Throughput increases are often associated with transfers of oil. 218 The requirements contained in this section, including those for secondary containment, warning systems, and inspection of trucks or cars for discharges are necessary to help prevent discharges. If you can justify a deviation for secondary containment requirement in paragraph (h)( 1) on the basis that it is not practicable from an engineering standpoint, you must provide a contingency plan and take other actions to comply with §112.7( d). If you seek to deviate from any of the requirements in paragraphs (h)( 2) or (3), you must explain your reasons for nonconformance, as provided in §112.7( a)( 2), and provide measures affording equivalent environmental protection. We disagree that a contingency plan (whether labeled "strong" or otherwise) is a preferable alternative to secondary containment. Secondary containment is preferable because it may prevent a discharge that may be harmful as described in §112.1( b). A contingency plan is a plan for action when such discharge has already occurred. However, as noted earlier, if secondary containment is not practicable, you must provide a contingency plan and take other actions as required by §112.7( d). EPA will continue to evaluate the issue of whether the provisions for secondary containment found in §112.7( h)( 1) should be modified or revised. We intend to publish a notice asking for additional data and comment on this issue. We disagree that the section regulates activities already under the purview of the U. S. Department of Transportation. We regulate the environmental aspects of loading/ unloading transfers at non­ transportation­ related facilities, which are legitimately part of a prevention plan. DOT regulates other aspects of those transfers, such as safety measures. Phase­ in. None of the requirements of §112.7( h) are new, therefore compliance is already required, and no phase­ in is necessary. Cost. We believe that we have considered costs adequately, and invite the interested reader to review the Regulatory Analyses in the docket for this rulemaking. This is not a new requirement, and therefore, none of the costs are "new". Appalachian and other oil production operators who are presently in compliance with these provisions will not incur additional economic impact as a result of the revision. Editorial suggestion. We disagree that we should change loading rack to "loading/ unloading area" because we did not propose the change. We disagree that we should move the requirements to §112.8. We intend §112.7( h) to apply to all facilities, including production facilities; §112. 8 does not cover production facilities. Other State or Federal law. We have withdrawn, as unnecessary, proposed §112.7( h)( 1), which would have required that facilities meet the minimum requirements of Federal and State law. Those requirements apply whether they are mentioned or not. Secondary containment. As noted above, the requirement for secondary containment applies to all facilities, whether with aboveground or completely buried containers. This 219 includes production facilities and small facilities. The method of secondary containment must be one of those listed in the rule (see §112.7( c)), or some similar system that provides equivalent environmental protection. The choice of method is one of good engineering practice. However, in response to comments, we note that sumps and drip pans are a listed method of secondary containment for offshore facilities. A catchment basin might be an acceptable form of retention pond for an onshore facility. Whatever method is implemented, it must be capable of containing the maximum capacity of any single compartment of a tank car or tank truck loaded or unloaded in the facility. A discharge from the maximum capacity of any single compartment of a tank car or tank truck includes a discharge from the tank car or tank truck piping and hoses. This is the largest amount likely to be discharged from the oil storage vehicle. A requirement that secondary containment be able to hold only five percent of a potential discharge when procedures are in place to prevent discharges fails to protect the environment if there is human error in one of those procedures. In case of discharge, the secondary containment system must be capable of preventing a discharge from that maximum capacity compartment to the environment. As mentioned above, if secondary containment is not practicable, you may be able to deviate from the requirement if you provide a contingency plan and otherwise comply with §112.7( d). Regarding the presence of personnel (as supervisors) to substitute for secondary containment, we agree that spill prevention is always preferable to spill containment. However, preventive measures do not replace the need for a secondary containment system as these measures will never completely eliminate the potential for a spill to occur. Such measures, however, might be part of the contingency plan required when secondary containment is impracticable. Quick drainage system. A quick drainage system is a device that drains oil away from the loading/ unloading area to some means of secondary containment or returns the oil to the facility. We note that this provision does not apply to any UST system excluded from part 112 under §112.1( d)( 4). Vehicle drain closure. We believe that the requirement to check vehicles for discharge is important to help prevent discharges. If the check were not done, the entire contents of the vehicle might be discharged. We further believe that the responsibility for compliance with proposed §112.7( h)( 3), as well as with all provisions of the rule, continues to rest with the owner or operator of the facility when those vehicles are loading or unloading oil at the facility. If personnel are not present to inspect the vehicles, the owner or operator must explain his reasons for nonconformance and provide equivalent environmental protection by some other means. See §112.7( a)( 2). X ­ K: State rules ­ §112.7( j) Background: Section 112.7( e) of the current rule requires an owner or operator to discuss conformance with §112.7 or more stringent State rules, requirements, and guidelines. In §112.7( i) of the 1991 proposed rule (redesignated as §112.7( f) in the final rule), we reproposed the requirement that in addition to the minimal prevention 220 standards listed under §112.7( c), (e), (f), (g), and (h) the owner or operator include in an SPCC Plan a complete discussion of conformance with the applicable requirements and "other effective spill prevention and containment requirements listed in §§ 112.8, 112.9, 112.10, and 112.11 (or, if more stringent, with State rules, regulations, and guidelines). Comments: Editorial suggestion. We should move §112.7( i) to §112.7( a)( 3). (121) "The proposed language which ties this section to the requirements in other sections of this regulation should be more clearly limited to those sections which are applicable to the facility in question. For example, requirements in section 112.8 ... should not (by the requirement in 112.7( i)) be applied to any portion of any production facility." (L12) Delegation. We should delegate SPCC program activities to States or explore opportunities to enter into contracts and other cooperative agreements with States. Delegating responsibility to the States would decrease costs to implement the program, and the number of inspections would increase. (27, 52, 111, 154, 185, 193) We should explore the possibility of a grants program to encourage State involvement. (27, 111) Federal and State regulation. Consistency with States. Urges "... EPA to be as consistent as possible with rules being adopted or developed by Washington and other states regarding standards for oil spill contingency and prevention plans given federal statutory limitations." (185) DOT rules. Asks why the proposed requirements are more restrictive than the United States Department of Transportation's (DOT's) requirements for transportation­ related facilities. The DOT facilities pose a higher risk of discharging oil than our non­ transportation­ related facilities. (119) Duplication. Our proposal is duplicative of other Federal and State programs, is confusing, and hinders an owner's or operator's ability to comply with applicable regulations. We should coordinate with other Federal and State agencies in revising the SPCC regulation. (35, 42, 82, 88, 111, 133, 139, 153, 173, 185, 193) We should exempt all facilities currently covered by other equivalent regulatory programs. (62, 173) Environmental overkill. "Several of these proposed regulations are more restrictive than State regulations, are environmental overkill, and would result in a facility incurring considerable expense to come into compliance." (88) Federal regulation unnecessary. "While the need for federal regulations is evident in some cases, this is not one of them. In many cases, the proposal overlaps programs already in place at the state level and thwarts the efforts of industry to comply with these environmental protection programs. Each state is unique in its geography, history, and environmental protection goals. Therefore, if states deem oil pollution prevention regulations are necessary to protect its 221 citizens, the states should be allowed to draft regulations that will work to solve their own unique problems." (139, 185, 193) NPDES. We should exempt facilities or tanks covered by a NPDES discharge permit. (35, 173) State regulation unnecessary. "With regard to expense, the act of encouraging State and Federal governments `to supplement the Federal SPCC programs' invites yet another raid on the treasuries of companies through `revenue enhancing' permit fees. Additionally, when blanket `encouragements' are extended, consideration should be given to the potential for a chaotic lack of uniformity that inevitably results." (45, 82) One plan. We should require one plan for facilities covered under the Clean Water Act (CWA), the Resource Conservation and Recovery Act (RCRA), and SARA Title III. (80) Other law. We should clarify that an owner or operator must comply with any applicable section of §§ 112.8 through 112.11 provision referenced in §112.7( i). For example, a reference in §112.7( i) to §112.8 would apply only to onshore facilities, excluding production facilities. (L12) Response: Consistency in rules. As noted above, you may now use a State plan as a substitute for an SPCC Plan when the State plan meets all Federal requirements and is cross­ referenced. When you use a State plan that does not meet all Federal requirements, it must be supplemented by sections that do meet all Federal requirements. At times EPA will have rules that are more stringent than States rules, and some States may have rules that are more stringent than those of EPA. If you follow more stringent State rules in your Plan, you must explain that is what you are doing. Cross­ referencing of requirements. In response to the commenter who believed that proposed §112.7( i) (redesignated in today's rule as §112.7( j)) might require him to discuss inapplicable requirements, we note that you must address all SPCC requirements in your Plan. You must include in your Plan a complete discussion of conformance with the applicable requirements and other effective discharge prevention and containment procedures listed in part 112 or any applicable more stringent State rule, regulation, or guideline. If a requirement is not applicable to a particular type of facility, we believe that it is important for an owner or operator to explain why. Delegation. We have no authority under the Clean Water Act to delegate our program or elements of it to the States. However, States may enact their own programs. Government agencies at the State and tribal level often exercise authority over SPCCregulated facilities that is similar to EPA's authority. Closer coordination with such government agencies could effectively expand SPCC's reach and effectiveness while helping State and tribal programs administer their own activities. This could be accomplished by the development of Memorandums of Understanding (MOUs) and 222 Interagency Agreements (IAGs) with individual States and tribes. EPA will also explore the development of a State and tribal partners program. In such a program States and tribes would participate on a voluntary basis and agree to perform some program functions and report information to a common information system in a prescribed format. EPA would maintain the databases and provide training and administrative support to participating States and tribes. This could include delivery of a fuels management class, and the sponsorship of training and conferences in every region for States and tribes to better understand the regulated universe and to better inspect target facilities. We will also explore better data tracking and sharing with States. Editorial suggestion. We believe that provision fits better at the end of §112.7 than in §112.7( a)( 3) because it references not only the provisions of §112.7, but the applicable sections of the part which follow, as well as reference to State rules, regulations, and guidelines. To simplify the rule language, we have amended the proposed rule to state that you must discuss all applicable requirements in the Plan instead of listing all of the sections individually. Federal and State regulation. Both the States and EPA have authority to regulate containers storing or using oil. We believe State authority to regulate in this area and establish spill prevention programs is supported by section 311( o) of the CWA. Some States have exercised their authority to regulate while others have not. We believe that State SPCC programs are a valuable supplement to our SPCC program. When no State program exists, the Federal program becomes even more necessary. We also note that you may use NPDES records for SPCC purposes, and may use a Best Management Practices Plan as an SPCC Plan if it meets all SPCC requirements, or may supplement so that it does. See §§ 112.7 (introduction), 112.7( e), 112.8( c)( 3)( iv), and 112.9( b)( 1). We also note that our facilities differ from DOT facilities in many important aspects, therefore different rules are necessary. Other law. Final §112.7( j) refers to applicable requirements in all of part 112 or more stringent State law. Preemption. We do not preempt State rules, and defer to State rules, regulations, and guidelines that are more stringent than part 112. 223 Category XI: Onshore facility Plan requirements (excluding production facilities) XI ­ A: Facility Drainage ­ §112.8( b) Background: Facility drainage. In 1991, we proposed several changes to §112.7( e)( 1) of the current rule on facility drainage at onshore facilities (excluding production facilities). We proposed to redesignated §112.7( e)( 1)( i) through (iv) of the current rule as §112.8( b)( 1) through (4). The proposed paragraphs addressed requirements for: facility drainage at a diked area, (b)( 1); the prohibition on a flapper­ type drain for diked areas, (b)( 2); drainage systems for undiked areas, and a diversion system for a facility where drainage failed to meet the requirements of paragraphs (b)( 1)­( 3), (b)( 4). In 1991, we proposed to redesignate §112.7( e)( 1)( i) of the current rule on facility drainage from diked areas, as §112.8( b)( 1). We proposed to redesignate §112.7( e)( 1)( ii) of the current rule, on the prohibition on flapper­ type drains for diked areas, as §112.8( b)( 2). We left redesignated paragraphs (b)( 1) and (2) substantially the same as the equivalent provisions in the current rule. We proposed to redesignate §112. 7( e)( 1)( iii) of the current rule, on covered drainage systems for undiked areas, as §112.8( b)( 3). However, in proposed paragraph (b)( 3), we clarified that an undiked area must drain into a pond, lagoon, or catchment basin only if the area is located such that it has a reasonable potential to be contaminated by an oil discharge. We also proposed to recommend ­­ rather than require ­­ that an owner or operator avoid placing a catchment basin in an area subject to periodic flooding. We proposed to redesignated §112.7( e)( 1)( iv) of the current rule as §112.8( b)( 4). In paragraph (b)( 4), we proposed a requirement that at a facility without a drainage system described in paragraphs (b)( 1) through (3), a diversion system must retain oil in the facility, rather than return oil to the facility after the oil already was discharged. XI­ A( 1) Diked storage area drainage ­ §112.8( b)( 1) Comments: Applicability. "Broadly read this could require a pond or lagoon to capture drainage from every inch of our manufacturing facilities." Suggests limiting proposal to "areas with potential to receive spills from tanks greater than 660 gallons or areas with tanks regulated under these rules." (126) Electrical equipment. The diked storage area drainage requirement should not apply to electrical utility systems (such as lubrication systems and hydraulic lift systems) that use oil for operational purposes. We should not regulate these systems as we would regulate a storage tank. (125) Secondary containment. "For facilities with site­ wide containment, or that have substantial storm water draining onto and across the site, providing such detention is not practical, and, ... , may encourage/ justify reliance on contingency plans in lieu of containment." (76) 224 De minimis amounts of oil. It would be impossible for owners or operators to ensure that "no oil" would be discharged into water from diked areas, because the human eye is incapable of perceiving minute amounts of oil in water. We should create a more objective standard, such as the "oil sheen" standard that appears in 40 CFR 110.3. (125) Oil/ water separators. "The use of oil water separators, underflow uncontrolled discharge devices, and other apparatus can substantially reduce the potential of a significant spill of floating or other products which can be separated by gravity." (76, 125) Response: Applicability. We disagree that we should limit the scope of this section to facilities having areas with the potential to receive discharges greater than 660 gallons or areas with tanks regulated under these rules. Small discharges (that is, of 660 gallons or less) as described in §112.1( b) from diked storage areas can cause great environmental harm. See section III. F of the preamble to today's rule for a discussion of the effects of small discharges. We disagree that this section should apply only to areas with tanks regulated under these rules because this rule applies to regulated facilities, not merely areas with regulated tanks or other containers. A facility may contain operating equipment within a diked storage area which could cause a discharge as described in §112.1( b). We disagree that the requirement is not practical for facilities with site­ wide containment, or that have substantial storm water draining onto and across the site. Where oil/ water separators, underflow uncontrolled discharge devices, or other positive means provide equivalent environmental protection as the discharge restraints required by this section, you may use them, if you explain your reasons for nonconformance. See §112.7( a)( 2). However, you must still ensure that no oil will be discharged when using alternate devices. De minimis amounts of oil. This rule is concerned with a discharge of oil that would become a discharge as described in §112.1( b). When oil is present in water in an amount that cannot be perceived by the human eye, the discharge might not meet the description provided in 40 CFR 110.3. Therefore, such a discharge might not be a discharge in a quantity that may be harmful, and therefore not a reportable discharge under part 110. However, a discharge which is invisible to the human eye might also contain components (for example, dissolved petroleum components) which would violate applicable water quality standards, making it a reportable discharge. Therefore, we are keeping the language as proposed, other than making some editorial changes. XI­ A( 2) Diked storage areas ­ valves used; inspection of retained stormwater 112.8( b)( 2) Comments: Innovative devices. "This section should be modified to make clear whether drainage systems that allow the passage of water but not oil, such as drains equipped with imbiber beads, may be used for facility drainage." (39, 76,125) 225 Response: Innovative devices. This rule does not preclude innovative devices that achieve the same environmental protection as manual open­ and­ closed design valves. If you do not use such valves, you must explain why. The provision for deviations in §112.7( a)( 2) allows alternatives if the owner or operator states his reasons for nonconformance, and provides equivalent environmental protection by some other means. However, you may not use flapper­ type drain valves to drain diked areas. And if you use alternate devices to substitute for manual, open­ and­ closed design valves, you must inspect and may drain retained storm water, as provided in §112.8( c)( 3)( ii), (iii), and (iv), if your facility drainage drains directly into a watercourse, lake, or pond bypassing the facility treatment system. XI­ A( 3) Drainage from undiked areas ­ §112.8( b)( 3) Comments: Support for proposal. We should permit facility drainage systems from undiked areas to flow into ponds, lagoons, or catchment basins designed to retain spilled oil or into the plant water treatment system, if that system is designed to retain spilled oil. (121) "Section 112.8( b)( 3) clearly envisions and allows for facilities which have undiked oil storage areas and provides a standard for the capture of any spill from such areas through the use of catchment basins, lagoons and the like using a design of the facility's choosing. Velsicol supports such a standard for undiked oil storage areas." (L26) Catchment basins. "It is highly unlikely that catchment basins will operate effectively during a flood event. Since these types of facilities could cause significant harm to the environment, EPA should require that catchment basins not be located in areas subject to flooding." (12) "Catchment basins in areas subject to flooding essentially ensure eventual surface water contamination. The proposed regulations should be expanded to require that no new facilities used for oil or hazardous substance storage are sited in floodplains, and drainage systems for existing facilities are engineered (even if it requires pumping of contaminated water to a higher level for storage prior to treatment) so that minimal amounts of contaminated water are retained in areas subject to periodic flooding." (44) Applicability ­ generally. We should require facility drainage systems from undiked areas to flow into a pond, lagoon, or catchment basin "where possible" or "if practicable." (54) It is impossible to specify what constitutes proper drainage control for all types of facilities. Therefore, we should retain the verb "should" as in the current rule "to allow for the exercise of good engineering practice." (125) Electrical equipment. "It would be very impractical to divert flow across an entire site to a pond, lagoon or catchment basin where such flow is currently uncollected or, if collected, is diverted to a storm drainage system prior to discharge. Indeed, for electrical equipment, there is an inherent inconsistency between the drainage requirements of proposed §112.8( b)( 3) and the secondary containment exclusion of proposed §112.8( c)( 2). ... A suggested method for reducing the impracticality and inconsistency of the proposed requirement is to 226 limit the applicability of §112. 8( b)( 3) to "systems with a potential for oil spill `discharge' into or upon the navigable waters of the United States rather than the broader and more encompassing potential for `contamination'." (100) The drainage requirements would impose a substantial financial burden on facility owners or operators and the burden on the electrical utility industry would outweigh the environmental benefits. (125) In urban areas, it would be impossible for owners or operators to meet the drainage requirements for transformers in vaults in large office and apartment buildings, and underneath urban streets. "Similarly, there is simply no space at such sites to construct the drainage control structures required by the proposal." (125, 189) Alternatives. "If it is the intent of the US EPA to require catchment for such areas, the operator should have the option of providing spill control by committing to the regular inspection of, and immediate clean­ up of spills, within such areas." (76) Asks clarification as to whether a properly sized and operated oil/ water separator meets the §112.8( b)( 3) requirement for drainage control. (92, 125) Response: Support. We appreciate commenter support. Applicability. We disagree that the rule language should become a recommendation because we believe that it is important to control the potential discharges the rule addresses. The rule does this by requiring retention of water within the facility from undiked areas if there is no provision for flow into ponds, lagoons, or catchment basins designed to retain oil or return it to the facility. Where a diversion system is infeasible, if you explain your reasons for nonconformance, you may provide equivalent environmental protection by an alternate means. In response to the commenter who questioned the applicability of this paragraph to areas under aboveground piping and loading/ unloading areas, we note that both areas are subject to the rule's requirements if they are undiked. Electrical equipment. The requirements of paragraph (b)( 3) apply to a facility with electrical equipment. If you determine it is infeasible to comply with the requirements of the paragraph, you must explain your reasons for nonconformance, and provide equivalent environmental protection. 40 CFR 112.7( a)( 2). Alternatives. The rule does not limit you to the use of drainage trenches for undiked areas. Other forms of secondary containment may be acceptable. The rule only prescribes requirements for the drainage of diked areas, but does not mandate the use of diked areas. However, if you do use diked areas, the rule prescribes minimum requirements for drainage of those areas. Also, if the requirement is not practical, you may explain your reasons for nonconformance and provide equivalent environmental protection under §112.7( a)( 2). XI­ A( 4) Diversion systems ­ §112.8( b)( 4) 227 Comments: "Ohio EPA agrees with the proposed language regarding facility drainage. The proposed language requires, rather than suggests, that facility drainage flow to a catchment basin, Also, oil is to be `retained' at the facility, rather than `returned. ' While we understand that this change implies that the spill should not leave the facility boundaries, it should be further clarified." (27) We should require the owner or operator either to retain oil within the facility or return it to the facility, whichever is applicable. The diversion system requirement should apply only to the "petroleum areas of the facility such as tanks, pipes, racks, and diked areas" because "drainage from the rest of the facility should not be contaminated and thus should not have to be diverted." (54) Response: The rule accomplishes the aim of retaining within the facility minimal amounts of contaminated water in undiked areas subject to periodic flooding. It is better that a diversion system retain rather than allow oil to leave the facility, thus enhancing the prevention goals of the rule. Furthermore, it should be easier to retain discharged oil rather than retrieve oil that has been discharged from the facility. Therefore, we agree with the commenter that "retained" oil is oil that never leaves the facility. We also agree that the rule applies only to drainage from the "petroleum" (or other oil) areas of the facility such as tanks, pipes, racks, and diked areas, because the purpose of the SPCC rule is to prevent discharges of oil, not of all runoff contaminants. Amendment of the rule language is unnecessary because all of the rule applies only to "petroleum" or "oil" areas of the facility. Therefore, we have promulgated the rule language as proposed with a minor editorial change. XI­ A( 5) Drainage systems ­ §112.8( b)( 5) Comments: PE certification. We should add a section to the rule requiring that Professional Engineers (PEs) certify the design and construction of the storm water drainage system and the sanitary sewer system, because the PE is in the best position to prepare the spill containment parts of the SPCC Plan. (47) Response: PE certification. PE certification is already required for the design of stormwater drainage and sanitary sewer systems by current rules because those systems are a technical element of the Plan. Therefore, we are keeping the language as proposed. XI­ A( 6) FEMA requirements ­ Proposed §112.8( b)( 6) Comments for this section were combined with comments for section XII­ D. XI ­ B: Bulk storage containers ­ §112.8( c) XI­ B( 1) Material and construction ­ §112.8( c)( 1) Background: Section 112.7( e)( 2)( i) of the current rule (redesignated as §112.8( c)( 1) of the final rule) requires an owner or operator of an onshore bulk storage facility to ensure 228 that the material and construction of tanks used to store oil are compatible with the material stored and conditions of storage. In §112.8( c)( 1), we proposed a new recommendation that the construction, materials, installation, and use of tanks conform with relevant portions of industry standards such as API, NFPA, UL, or ASME standards. Comments: Support for proposal. "Based on the preamble, it is apparent that the use of industry standards is intended to be a recommendation and not a requirements. Valvoline fully supports the use of standards in this manner as they were not developed for use as regulatory requirements and are not applicable or necessary in all possible situations. As a result, their use should be discretionary utilizing good engineering practices as appropriate. However, the wording utilized in section 112. 8( c)( 1) taken in conjunction with section 112.7( a) is contradictory as to whether or not the use of industry standards is a recommendation or a requirement." (67, 95, 102, 115, 148) Opposition to proposal. We should not place recommendations in the regulation. We should not ask owners or operators to consider good engineering practice since this makes the regulation unenforceable. Instead, we should tell the owner, operator, or certifying engineer what good engineering practice requires. We should substitute proposed §112.8( c)( 2) with the proposed §112.8( c)( 1) text and delete the recommendation, which is "advisory and unenforceable." (121) Additional industry standards. In §112.8( c)( 1), we should reference the Steel Tank Institute (STI) standard F911­ 91, "Standard for Unitized Steel Aboveground Storage Tank Systems with Open Top Secondary Containment." (140) The industry standards listed in the preamble are "extremely important," but these standards do not address the physical site and its surrounding lands and waters. (L4) Requirement instead. The rule should require, not recommend, that tanks meet industry standards. "At a date certain, all existing tanks should be upgraded to meet industry codes. Moreover, all new and reconstructed tanks should be subject to applicable codes." (44) We should change §112.8( c)( 1) to require the following: "All tanks constructed after the effective date of this part must be constructed to one of the following industry standards (list here the standards acceptable to EPA). The owner or operator shall retain records, as part of the (SPCC Plan), to show which standard was used in the construction of the tank, and a certification plate, setting forth the standard to which the tank was constructed and the date of its construction shall be permanently affixed to the tank." (121) Response: Requirement v. recommendation. The first sentence of the proposed rule indeed contemplated a requirement, i. e., that no container may be used for the storage of oil unless its material and construction are compatible with the material stored and the conditions of storage, such as pressure or temperature. The second sentence, which was clearly a recommendation, has been deleted from the rule because we have decided to remove all recommendations from the rule language. Rules are mandates, and we do not wish to confuse the regulated community as to what actions are 229 mandatory and what actions are discretionary. The Professional Engineer must, pursuant to §112.3( d)( 1)( iii), certify that he has considered applicable industry standards in the preparation of the Plan. While he must consider such standards, use of any particular standards are a matter of good engineering practice. Additional industry standards. While we do not specify particular standards in the rule, we endorse the use of industry standards. We note that the discussion of many sections of the rule addresses particular industry standards. Section 112.8( c)( 2). We will address issues relating to §112.8( c)( 2) under the discussion of that section. XI ­ B( 2) Secondary containment for bulk storage containers at onshore facilities ­ §112.8( c)( 2) Background: In 1991, we proposed to redesignated the §112.7( e)( 2)( ii) secondary containment requirements of the current rule as §112.8( c)( 2), and make some revisions. We gave notice in the preamble that "sufficient freeboard" to contain precipitation is freeboard sufficient to contain a 25­ year storm event. We also proposed that diked areas be sufficiently impervious to contain spilled oil for at least 72 hours. The rationale for the 72­ hour standard was to allow time for the discovery and removal of a discharge. Electrical equipment. In the 1991 preamble, we noted that certain facilities may have equipment such as electrical transformers that contain significant quantities of oil for operations rather than for storage. For safety and other considerations, we determined that we should not require an owner or operator of such oil­ filled equipment to comply with §112.8( c) or §112.9( d) secondary containment requirements, because storage of oil in bulk is not the primary purpose of such equipment. Therefore, we stated that an owner or operator of a facility with equipment containing oil for ancillary purposes does not need to provide secondary containment for this equipment or implement the other provisions of proposed §112.8( c) (or §112.9( d). 56 FR 54623. However, an owner or operator of oil­ filled equipment must meet other applicable SPCC requirements including the requirements of §112.7( c), to provide appropriate containment and diversionary structures to prevent discharged oil from reaching navigable waters. Comments: De minimis containers. "Request that some de minimis limit be set for requiring secondary containment. While in some cases secondary containment for the largest tank is acceptable, can manufacturers may have several smaller tanks, none of which should be considered large." (62) Designations. "In extraordinary circumstances, EPA Solid Waste and Emergency Response should designate local fire regulatory authorities and/ or state and local EPA's to make decisions concerning `deemed equivalency' for secondary containment, as is done by the UST section of EPA." (65) 230 Double­ walled or vaulted tanks. We should allow an owner or operator to use prefabricated vaulted, or double­ walled tanks with secondary containment under §112.8( c). (65, 79, 140, 144, 179) Facility size. "Recognizing EPA's limited funding and enforcement resources, EPA should consider allowing the state EPA's and the fire regulatory authorities to continue to regulate the small `throughput' vaulted tank industry which fire regulatory authorities have defined as 6,000 per tank and 18,000 gallons per site." (65, 79) Fire codes. "Deem as equivalent for EPA purposes, the secondary containment of VAST technology which meets any of EPA­ recognized industry standards of the model fire codes of NFPA, BOCA, or UFC." (65) Freeboard. Double­ walled steel tanks with integral secondary containment, and other factory­ fabricated tanks with secondary containment are designed so that precipitation does not collect within the secondary containment. (65, 140) Asks us to address the technical construction design of steel tanks with factoryfabricated secondary containment in the §112.8( c)( 2) freeboard requirements. (140) A double­ walled "F921­ 92" AST or its equivalent does not need freeboard because it is entirely enclosed; the outside tank is larger than the inside tank and will hold the entire contents of the primary tank. (179) Impermeability. VASTs are impervious to oil for 72 hours. (65) Outer­ steel wrap. The secondary containment provided by a factory­ fabricated, "integral outer­ steel wrap" is acceptable if the system has additional mechanisms to prevent overfill and provide containment. (140) Regional opposition. "Working mostly with fire prevention personnel and codes, but with environmental protection of equal concern, several styles of tanks have been developed which will meet the intent of the proposed regulations for protection of the environment, but based on an interpretation from Region 10 have not ben allowed to be used." (108, 122) Vandalism and fire. A VAST's concrete encasement provides protection against vandalism and fire. VASTs allow an owner or operator to dike the contents of every tank, rather than only the single largest tank. (65) Editorial suggestions. Recommends that we move the proposed §112.8( c)( 2) on secondary containment requirements to the proposed §112.8( c)( 3) on drainage requirements. Asks that we change the phrase "all bulk storage tank installations" to "tanks" in the proposed §112.8( c)( 2) sentence, "All bulk storage tank installations should be constructed so that a secondary means of containment is provided for the entire contents of the largest single tank and sufficient freeboard to allow for precipitation." (121) 231 Electrical or other operating equipment. Support for proposal that an owner/ operator who has equipment containing oil for ancillary purposes need not have secondary containment nor comply with the §112.8( c) and §112.9( d) bulk storage container provisions. (66, 103, 125, 132, 134, 156, 164, L7, L20) Fire, hazard, safety considerations. Installing secondary containment for electrical equipment may create electrical and fire hazards. (125) We should clarify what "safety and other considerations" make it appropriate to exclude electrical equipment from secondary containment requirements. (L17) Leak detection. An owner or operator can immediately detect a leak from electrical equipment because a leak would trigger the alarm system. (66, 98, 138, L20) Electrical equipment is constructed with pressure relief devices and that a leak from one unit would not affect another unit. (L20) Operating equipment. We should exclude from the secondary containment requirements: trash compactors and process or water pumps; lubricating oil used in engines, turbines, compressors, and expanders; oil circuit breakers and auto boosters; oil held temporarily in the internal or external storage compartment of an oil/ water separator; oil used in cranes, jacks, elevators, and forklifts; hydraulic lift systems; throughput­ type tanks; wastewater treatment tanks; and capacitors and oil­ based heaters. (62, 65, 66, 102, 107, 125, 132, L7) Manifolded tanks. "The term `single largest tank' should be modified to include tanks which are manifolded together, or otherwise have overflow capabilities." (27) Seventy­ two­ hour impermeability standard. See the discussion on §112.7( c) for the comments on this subject. Secondary containment, in general. Supports requirement. Secondary containment for storage containers, including mobile storage containers, should be adequate to contain the contents of the largest, single tank within the secondary containment with freeboard sufficient for precipitation from a 25­ year storm event. The State of New Jersey has this requirement. (27, 147) Opposes requirement. Requiring secondary containment for small ASTs is unduly burdensome and impractical, and would require owners or operators to staff and monitor otherwise unstaffed sites. (69) Asks us to consider promulgating a "more realistic" provision for secondary containment systems (71). We have no justification for requiring an owner or operator to provide secondary containment for the contents of the largest single tank, or for requiring an owner or operator to provide freeboard sufficient to allow for precipitation. The commenter cited our "Analysis of Implementing Permitting Activities for Stormwater Discharges Associated with Industrial Activity" document as evidence 232 of the minimal risk posed by secondary containment overflow (July 1991). (173) We should recognize that secondary containment installation is not possible for all tanks (e. g., indoor tanks). (175) Contingency planning instead. Asks us to follow the Federal Aviation Administration's example, and allow an owner or operator of a facility with "small numbers of small capacity ASTs" to conduct contingency planning and training instead of installing secondary containment. We should use the fire prevention code to define the term "small numbers of small capacity ASTs" as "less than a total capacity of 6, 000 gallons per facility." (69) Largest single tank. Not all facilities "have enough property to provide this volume of containment," which would result in an enormous operational burden for existing facilities. However, we should require secondary containment for existing tanks with a volume greater than 100,000 gallons. (90) "Impervious containment of a volume larger than the largest single tank may not be necessary for all tanks." (90,126) Methods. "In other words, we recommend that the free choice of design offered to the facility by 112. 8( b)( 3) be preserved in 112. 8( c)( 2) and not be narrowed to allow only drainage trench enclosures in cases where diking is not used." (L26) Oil/ water separators. Asks us to allow properly sized and operated oil/ water separators to meet the drainage control and secondary containment requirements. (98) Phase­ in. We should phase­ in secondary containment requirements, and apply them to large facilities only. (116) Underground cable systems. "Even if secondary containment systems could be installed, the costa are likely to be prohibitive. ... Electric utilities already have operational response plans to address leaks as part of their planning to prevent disruption of service." (125) "Should to shall" cost. We reduced the impact of the proposal by failing to consider the cost of changing "should" to "shall," and cited the secondary containment requirement as an example. The proposed rule requires an owner or operator to equip all tank batteries with secondary containment, although many petroleum extraction industry tank batteries do not have secondary containment because of the cost or lack of need. (L27) Snow and ice. "In the case of many Rocky Mountain fields, secondary containment in the form of dikes is worthless because of drifting snow which turns to ice filling the diked area." (L27) Sufficient freeboard. 233 Alternatives to freeboard. "Also, the regulations should specify that maintaining any freeboard does not apply when rainguards are used to divert storm water and keep it from accumulating in the diked area." (88) "E& P operations should have the option to use portable/ permanent pumps or water hauler trucks for removal of any 25 year storm water event. KMS believes the more appropriate and applicable standard is the 10­ year event." (114) Clarification needed. We should clarify what we mean in §112.8( c)( 2) by "sufficient freeboard." (54, 154, 179, L18) 10­ year storm event. It would be adequate to provide freeboard sufficient to contain precipitation from a 10­ year storm event, or more specifically, a 10­ year, 24­ hour storm event. (48, 80, 87, 95, 102, 114, 133, L3, L12) 25­ year storm event. Opposes recommendation. "It will be difficult and would require meteorological studies over a period of time to determine what freeboard is sufficient to contain a 25 year storm event." (34, 53) "We should consider as sufficient, a tank's ability to contain 110 percent of the capacity of the largest tank, which is an accepted industry standard and consistent with good engineering practice. (34, 48, 54, 133, L7) "We feel that the 25 year storm containment recommendation is unduly stringent, and would impose considerable costs without any significant benefits." (80) We should allow flexibility for determining whether a facility has adequate freeboard. There is not enough space to retrofit the containment areas required to provide freeboard for a 25­ year storm for all facilities. (88) "The chances of a secondary containment dike being full of oil at the same time that a 24­ hour, 25­ year storm event takes place is astronomically small. Freeboard capable of holding a 24­ hour, 10­ year storm event is sufficient." (102) The volume from a 25­ year storm event should remain as a recommendation, but we should not specify the amount of precipitation accumulated from a 25­ year storm event because it will vary depending on the location. States may require a specific freeboard capacity. (143) "The rubber industry is concerned that the 25­ year freeboard `recommendation' will be interpreted as a `requirement'." (L3) "This `requirement' may be sufficient for new storage tanks. Secondary containment for previously installed tanks, however, may have been designed for 100% of the largest tank, 110% of the largest tank, 100% of the largest tank plus 0.5 inches of rain, or another viable measure. EPA should provide some variance to allow existing containment to meet the intent of the law, and thereby not requiring small additions to the containment structure with minimum resulting benefit." (L7) Clarification needed. We should clarify what we meant by "sufficient to contain a 25­ year storm event." (54) Asks clarification of the duration and the recurrence frequency of the 25­ year storm event. (76, 87, 102, 114) 234 Response: De minimis containers. We have established a de minimis container size of less than 55 gallons. You do not have to provide secondary containment for containers of less than 55 gallons. Designations. We disagree that we should designate State and local authorities to determine whether a tank meets the §112.8( c) secondary containment requirements. We have no authority under the Clean Water Act to delegate elements of the SPCC program to State or local governments. We likewise disagree that we should that we should designate Federal authorities, including our regional offices, to determine whether a container meets the §112.8( c) secondary containment requirements. Such a determination is in the first instance one for the owner or operator to make in consultation with his Professional Engineer. If the Regional Administrator disagrees with this determination, he may require the owner or operator to amend his Plan. Double­ walled or vaulted tanks. The term "vaulted tank" has been used to describe both double­ walled tanks (especially those with a concrete outer shell) and tanks inside underground vaults, rooms, or crawl spaces. While double­ walled or vaulted tanks are subject to secondary containment requirements, shop­ fabricated double­ walled aboveground storage tanks equipped with adequate technical spill and leak prevention options might provide sufficient equivalent secondary containment as that required under §112.7( c). Such options include overfill alarms, flow shutoff or restrictor devices, and constant monitoring of product transfers. In the case of vaulted tanks, the Professional Engineer must determine whether the vault meets the requirements for secondary containment in §112.7( c). This determination should include an evaluation of drainage systems and of sumps or pumps which could cause a discharge of oil outside the vault. Industry standards for vaulted tanks often require the vaults to be liquid tight, which if sized correctly, may meet the secondary containment requirement. There might also be other examples of such alternative systems. Larger, field­ erected tanks (generally over 12,000 gallons) should not be without more traditional forms of secondary containment as listed in §112.7( c) because of the higher risk of uncontrolled discharges from such tanks due to tank size, design, and pumping rates. Editorial suggestions. We disagree that we move should §112.8( c)( 2) secondary containment requirements to §112.8( c)( 3) with drainage requirements. Drainage and secondary containment are discrete subjects which should be handled separately. In the first sentence, "spill" becomes "discharge." Also in that sentence, "contents of the largest single tank" becomes "capacity of the largest single container." This is merely a clarification and has always been the intent of the rule. The contents of a container may vary from day to day, but the capacity remains the same. In discussing capacity, we noted in the 1991 preamble that "the oil storage capacity (emphasis added) of the equipment, however, must be included in determining the total storage capacity of the facility, which determines whether a facility is subject to the Oil Pollution Prevention regulation." 56 FR 54623. We discuss this capacity in the context of the general requirements for secondary containment. Thus, it is clear that we have always intended 235 capacity to be the determinative factor in both subjecting a facility to the rule and in determining the need for secondary containment. We also deleted the phrase "but they may not always be appropriate" from the third sentence of the paragraph because it is confusing when compared to the text of §112.7( d). Under §112.7( d), if secondary containment is not practicable, you may provide a contingency plan in your SPCC Plan and otherwise comply with that section. In the last sentence, "plant" becomes "facility." Also in that sentence, the phrase "so that a spill could terminate...." becomes "so that any discharge will terminate...." Electrical or other operating equipment. Because electrical, operating, manufacturing equipment are not bulk storage containers, the §112.8( c)( 2) secondary containment requirement is inapplicable to those devices or equipment. 56 FR 54623. However, the general secondary containment requirement at §112.7( c) is applicable. If it is not practicable from a matter of good engineering practice (for example, because of safety reasons or the danger of fire or explosion) to install secondary containment for oil­ filled equipment, the owner or operator must provide a contingency plan following part 109 and otherwise comply with §112.7( d). Model fire codes. Compliance with a model fire code may be acceptable under §112.8( c) if the code meets the requirements of the section. We note that we meet with fire code officials from time to time. Secondary containment, in general. A primary containment system is the container or equipment in which oil is stored or used. Secondary containment is a requirement for all bulk storage facilities, large or small, manned or unmanned; and for facilities that use oil­ filled equipment; whenever practicable. Such containment must at least provide for the capacity of the largest single tank with sufficient freeboard for precipitation. A discharge as described in §112. 1( b) from a small facility may be as environmentally harmful as such a discharge from a large facility, depending on the surrounding environment. Likewise, a discharge from a manned facility needs to be contained just as a discharge from an unmanned one. A phase­ in of these requirements is not appropriate because secondary containment is already required under current rules. When secondary containment is not practicable, the owner or operator of a facility may deviate from the requirement under §112.7( d), explain the rationale in the Plan, provide a contingency plan following the provisions of 40 CFR part 109, and otherwise comply with §112.7( d). Because a pit used as a form of secondary containment may pose a threat to birds and wildlife, we encourage an owner or operator who uses a pit to take measures to mitigate the effect of the pit on birds and wildlife. Such measures may include netting, fences, or other means to keep birds or animals away. In some cases, pits may also cause a discharge as described in §112. 1( b). The discharge may occur when oil spills over the top of the pit or when oil seeps through the ground into groundwater, and thence to navigable waters or adjoining shorelines. Therefore, we recommend that an owner or operator not use pits in an area where such pit may prove a source of such discharges. 236 Should the oil reach navigable waters or adjoining shorelines, it is a reportable discharge under 40 CFR 110.6. We disagree that the rule is duplicative of NPDES rules. Forseeable or chronic point source discharges that are permitted under CWA section 402, and that are either due to causes associated with the manufacturing or other commercial activities in which the discharger is engaged or due to the operation of treatment facilities required by the NPDES permit, are to be regulated under the NPDES program. "Classic spill" situations are subject to the requirements of CWA section 311. Such spills are governed by section 311 even where the discharger holds a valid and effective NPDES permit under section 402. 52 FR 10712, 10714. Therefore, the typical bulk storage facility with no permitted discharge or treatment facility would not be under the NPDES rules. The secondary containment requirements of the rule apply to bulk storage containers and their purpose is to help prevent discharges as described in §112.1( b) by containing discharged oil. NPDES rules, on the other hand, may at times require secondary containment, but do not always. Furthermore, NPDES rules may not always apply to bulk storage facilities. Therefore, the rule is not always duplicative of NPDES rules. Where it is duplicative, an owner or operator of a facility subject to NPDES rules may use that portion of his Best Management Practice Plan as part of his SPCC Plan. Alternatives. Oil/ water separators. The rule does not mandate the use of any specific means of secondary containment. Any system that achieves the purpose of the rule is acceptable. That purpose is to prevent discharges as described in §112.1( b). Phase­ in. There is no need for a phase­ in of secondary containment requirements because they are already in effect and apply to all facilities, large and small. Snow and ice. We disagree that secondary containment is unnecessary for facilities in which drifting snow turns to ice in the diked area. Such snow or ice may be contaminated with oil and cause harm to the environment if it escapes the facility. Seventy­ two­ hour impermeability standard. As noted above, we have decided to withdraw the proposal for the 72­ hour impermeability standard and retain the current standard that diked areas must be sufficiently impervious to contain oil. We take this step because we agree with commenters that the purpose of secondary containment is to contain oil from reaching waters of the United States. The rationale for the 72­ hour standard was to allow time for the discovery and removal of an oil spill. We believe that an owner or operator of a facility should have flexibility in how to prevent discharges as described in §112.1( b), and that any method of containment that achieves that end is sufficient. Should such containment fail, an owner or operator must immediately clean up any discharged oil. Similarly, we intend that the purpose of the "sufficiently impervious" standard is to prevent discharges as described in §112.1( b) by ensuring 237 that diked areas can contain oil and are sufficiently impervious to prevent such discharges. "Should to shall" cost. There is no cost in the "should to shall to must" change because the change is merely editorial. Sufficient freeboard. An essential part of secondary containment is sufficient freeboard to contain precipitation. Whatever method you use to calculate the amount of freeboard that is "sufficient" must be documented in the Plan. We believe that the proper standard of "sufficient freeboard" to contain precipitation is that amount necessary to contain precipitation from a 25­ year, 24­ hour storm event. That standard allows flexibility for varying climatic conditions. It is also the standard required for certain tank systems storing or treating hazardous waste. See, for example, 40 CFR 265.1( e)( 1)( ii) and (e)( 2)( ii). While we believe that 25­ year, 24­ hour storm event standard is appropriate for most facilities and protective of the environment, we are not making it a rule standard because of the difficulty and expense for some facilities of securing recent information concerning such storm events at this time. Recent data does not exist for all areas of the United States. Furthermore, available data may be costly for small operators to secure. Should recent and inexpensive information concerning a 25­ year, 24­ hour storm event for any part of the United States become easily accessible, we will reconsider proposing such a standard. XI ­ B( 3) Drainage of rainwater ­ §112.8( c)( 3) Issues. In 1991, we also proposed several changes to §112.7( e)( 2) of the current rule on bulk storage tanks at onshore facilities (excluding production facilities). Specifically, we proposed to redesignated §112.7( e)( 2)( iii) as §112. 8( c)( 3). Proposed paragraph (c)( 3) addressed drainage from diked areas around bulk storage tank installations. It contains requirements for drainage of uncontaminated rainwater from a diked area into a storm drain or discharge of an effluent into an open watercourse, lake, or pond, bypassing the facility treatment system. Comments: NPDES. Records of discharges that do not violate water quality standards are unnecessary. "It is more logical and less confusing to train operators to report by exception." (88) "To avoid unnecessarily duplicative and overlapping work, we request that the Agency clarify that records and testing normally required for a permitted outfall under the NPDES program are adequate to fulfill the requirements under this section." (92) Methods. The proposed requirement in §112.8( c)( 3) to close and seal drains on dikes or equivalent measures at all times, except when rainwater is being drained, precludes engineering measures, such as standpipes, based on good engineering practice. Requiring the closing of standpipe valves defeats the purpose of installing the valves in the first place. (28, 101, 165, L15, L27) 238 Response: Methods. Acceptable measures might, depending on good engineering practice, include using structures such as standpipes designed to handle flow­ through conditions at certain oil production operations, where large volumes of water may be directed to oil storage tanks if water discharge lines on oil­ water separators become plugged. NPDES. We are not adopting the NPDES rules for SPCC purposes, but are only offering an alternative for recordkeeping. The intent of the rule is that you may, if you choose, use the NPDES stormwater discharge records in lieu of records specifically created for SPCC purposes. We are not incorporating the NPDES requirements into our rules by reference. This paragraph applies to discharges of rainwater from diked areas that may contain any type of oil, including animal fats and vegetable oils. The only purpose of this paragraph is to offer a recordkeeping option so that you do not have to create a duplicate set of records for SPCC purposes, when adequate records created for NPDES purposes already exist. XI ­ B( 4) Completely buried tanks; corrosion protection ­ §112.8( c)( 4) Background: In 1991, we redesignated and reproposed current §112.7( e)( 2)( iv) as §112.8( c)( 4), to require that an owner or operator protect new completely buried storage tanks installed on or after January 10, 1974, from corrosion by coatings, cathodic protection, or other effective methods compatible with local soil conditions. In 1991, we also proposed changing the §112.7( e)( 2)( iv) requirement for regular pressure testing to a recommendation for regular leak testing of buried tanks. We specified leak testing rather than pressure testing to be consistent with many State rules. Because completely buried tanks currently subject to the technical requirements of 40 CFR parts 280 and 281, the underground storage tank (UST) regulations, are generally exempted from SPCC requirements under proposed §112.1( d)( 4), §112.8( c)( 4) applies only to tanks not subject to 40 CFR part 280 or 281. Comments: Part 280 standards. We should avoid duplicative environmental requirements by expressly stating that metallic USTs must meet the "appropriate requirements of 40 CFR 280." (44, 67, 85, 111, 175, 180) Corrosion protection. Support for proposal. "We support the proposed requirement for protective coating and cathodic protection for new or replaced buried piping, regardless of soil conditions." (L17) Opposition to proposal. "Unenforceable." Proposal "is unenforceable." (121) 239 Monitoring effectiveness. "...( T) he regulation contains no discussion of cathodic protection for tank bottoms in contact with soil or fill materials. Also the regulation includes no requirements for monitoring the effectiveness of cathodic protection of buried tanks and piping." (16) Leak testing. Support for proposal. Support for our proposal for discretionary leak (or discharge) testing with some modifications. (48, 67, 85, 102) "ILMA agrees that making this a recommended, rather than mandatory, practice is consistent with the goal of using good engineering practice. This offers regulated facilities the flexibility to monitor these tanks with a frequency necessitated by site­ specific circumstances, such as the ages of the tanks or soil conditions." (48) Opposition to proposal. "As to leak testing, there is no current requirement for integrity testing of buried piping at storage facilities. At very large facilities it may be practical to conduct the type of testing proposed. However, for small and medium facilities it is impractical and would be extremely costly to implement this recommended practice." (34) Response: Corrosion protection. We agree in principle that all completely buried tanks should have some type of corrosion protection, but as proposed, we will only extend that requirement to new completely buried metallic storage tanks. Because corrosion protection is a feature of the current rule (see §112.7( e)( 2)( iv)), the requirement applies to completely buried metallic tanks installed on or after January 10, 1974. The requirement is enforceable because it is a procedure or method to prevent the discharge of oil. See section 311( j)( 1)( C) of the CWA. Most owners or operators of completely buried storage tanks will be exempted from part 112 under this rule because such tanks are subject to all of the technical requirements of 40 CFR part 280 or a State program approved under 40 CFR 281. Those tanks subject to 40 CFR part 280 or a State program approved under 40 CFR part 281 will follow the corrosion protection provisions of that rule, which provides comparable environmental protection. Those that remain subject to the SPCC regulation must comply with this paragraph. The rule requires corrosion protection for completely buried metallic tanks by a method compatible with local soil conditions. Local soil conditions might include fill material. The method of such corrosion protection is a question of good engineering practice which will vary from facility to facility. You should monitor such corrosion protection for effectiveness, in order to be sure that the method of protection you choose remains protective. See §112.8( d)( 1) for a discussion of corrosion protection for buried piping. UST standards. UST or other industry standards may satisfy SPCC requirements. Leak testing. The current SPCC rule contains a provision calling for the "regular pressure testing" of buried metallic storage tanks. 40 CFR 112. 7( e)( 2)( iv). We 240 proposed in 1991 a recommendation that such buried tanks be subject to regular "leak testing." Proposed §112.8( c)( 4). Leak testing for purposes of this paragraph is testing to ensure liquid tightness of container and whether it may discharge oil. We specified leak testing in the proposal, instead of pressure testing, in order to be consistent with many State regulations and because the technology on such testing was rapidly evolving. 56 FR at 54623. We are modifying the leak testing recommendation to make it a requirement. We agree with the commenter who argued that such testing should be mandatory because recommendations may not often be followed. Appropriate methods of testing should be selected based on good engineering practice. Whatever method and schedule for testing the PE selects must be described in the Plan. Testing under the standards set out in 40 CFR part 280 or a State program approved under 40 CFR part 281 is certainly acceptable (as we suggested in the proposed rule). "Regular testing" means testing in accordance with industry standards or at a frequency sufficient to prevent leaks. XI ­ B( 5) Partially buried or bunkered tanks ­ §112.8( c)( 5) Background: Under §112.7( e)( 2)( v) of the current rule, a partially buried metallic tank must be avoided unless the shell is coated, since damp earth can cause rapid corrosion of a buried tank, especially where air and soil contact. In 1991, we proposed in §112.8( c)( 5) to recommend against storing oil in partially buried or bunkered metallic tanks. However, if such tanks are used, we proposed to require that the owner or operator protect the buried or bunkered metallic tank from corrosion by using coatings, cathodic protection, or other methods compatible with local soil conditions. Comments: Applicability. We should clarify that the proposed recommendation applies only to new partially buried tanks. (54) Editorial suggestion. We could omit §112.8( c)( 5) by removing the term "partially buried tanks." (180) Requirement v. recommendation. Recommends that we delete the first sentence of §112.8( c)( 5) because it is purely advisory. (121) Response: Applicability. The requirement to avoid the use of such tanks, unless they are protected from corrosion, applies to all partially buried metallic tanks, installed at any time. This requirement is in the current rule and applies to tanks installed since the effective date of the rule in 1974. Editorial suggestion. We disagree that we should remove the term "partially buried tanks" or delete §112.8( c)( 5). Such a deletion would remove partially buried tanks from the corrosion protection requirements of the rule. Requirement v. recommendation. Due to the risk of discharge caused by corrosion, we decided to keep the current requirement to not use partially buried metallic tanks, unless 241 the buried section of such tanks are protected from corrosion. The requirement to not use such tanks, unless they are protected from corrosion, applies to all partially buried metallic tanks, installed at any time. XI ­ B( 6) Integrity testing ­ §112.8( c)( 6) Background: Current §112.7( e)( 2)( vi) requires an owner or operator to conduct periodic integrity testing of aboveground bulk storage tanks, taking into account tank design and using such techniques as hydrostatic testing, visual inspection, or a system of non­ destructive shell thickness testing. In 1991, we proposed to redesignated §112.7( e)( 2)( vi) as §112.8( c)( 6), and to require that an owner or operator of a facility with adequate secondary containment conduct integrity testing of aboveground bulk storage tanks every ten years and when there are material repairs to an aboveground tank. We also proposed to maintain the current requirement for keeping comparison records and for inspecting the tank's supports and foundations. Further, we proposed to maintain the current requirement for operating personnel to observe the outside of the tank frequently for signs of deterioration, leaks, or oil accumulation inside diked areas. Comments: Support for proposal. "Ashland supports the agency's proposal to require integrity testing of bulk storage tanks once every ten years and when material repairs are performed." (83, 102, L35) Opposition to proposal. Air emissions, fatalities. The release of gas from testing would increase air emissions and the risk of fatalities. Tanks "in severe environments or service" may not have a ten­ year life expectancy. (67) . Cost, out­ of­ service tanks. Owners or operators would have to build replacement tanks for the 10 percent of tanks taken out­ of­ service every year for testing. (67) Logistically difficult. Internally inspecting tanks is costly and logistically difficult. (L35) Environmental threat. Integrity testing is unwarranted since many tanks are inspected daily, and tanks located inside buildings are less likely to pose an environmental threat than outside tanks. (71) The ten­ year testing requirement is costly and may not have an environmental benefit, since secondary containment contains the tank's contents if there is a failure. (90) Residual oil. "A ten­ year testing cycle is simply not justified for residual oil tanks. Such relatively frequent forced outages will likely impact system reliability in the context of maintaining reserve capacity requirements if, for example, a particular generating unit is supplied from a specific fuel oil tank or an alternative fuel is unavailable. And perhaps more important, the compensating mechanism for avoiding station outages, i. e., to barge or truck­ in fuel in lieu of tank supplies, is 242 far more environmentally threatening. Consequently, Con Edison recommends that residual oil tanks be excluded from the testing frequency proposed in the revised section 112.8( c)( 6) or alternatively, that the testing of these tanks be tied to practical operational factors such as scheduled maintenance outages." (100, L35) Unnecessary, hazardous waste. Integrity testing is unnecessary because "tanks that store oil have a lower rust potential" (71) and "cleaning would generate more hazardous waste" (67). Applicability. Airport fuel systems. "This recommendation does not mention airport fuel hydrant systems associated with above ground fuel storage facilities ...." (107) Electrical equipment. Tank integrity testing requirement for electric equipment containing oil is burdensome and has no environmental benefit. Owners or operators would have to test such equipment while it was out­ of­ service, which is impractical. (92) "While the electric utilities generally believe that this is a reasonable proposal, we believe that two exclusions should be provided. First, ..., an exclusion should be provided for tanks used to store oils with a pour point greater than 60 degrees Fahrenheit. Such tanks pose little risk to navigable waters because the oil does not flow freely. ... A second exclusion should be provided for tanks that are capable of visible inspection on all sides and utilize secondary containment." (92, 125, L2) Phase­ in. 10 years. Suggests testing be phased in over the "next ten years after enactment of the final rule." (92, 125) UST model. "There should be a phase­ in period for testing of aboveground tanks subject to 112.8( c)( 6). This could be based on age of the tank and modeled after the UST program requirements for phase­ in of leak detection." (161) Small facilities. We should differentiate between large and small facilities because the ten­ year testing requirement is inappropriate for small tanks at small facilities. (34) "GM also believes that mandatory testing of aboveground tanks every ten years at a minimum, is unnecessary for small volume tanks and at facilities that have incorporated secondary containment structures." (90) We should consider exempting tanks based on size and tanks with 100 percent containment. (191) Suggested threshold levels. 243 Less than 2,000 gallons. We should exempt from the testing requirement, tanks contained within a building or with a maximum capacity of less than 2,000 gallons, tanks with all sides visible, and tanks and any associated piping and ancillary equipment that are visually inspected monthly. (71) 10,000 gallons or more. We should require an owner or operator to inspect aboveground tanks with a capacity of 10,000 gallons or more internally for structural soundness, tank bottom corrosion, and wall thinning. An owner or operator could conduct hydrostatic testing between ten year intervals, but not as a substitute for a thorough inspection. (111) Type of oil stored. "The proposed amendment does not properly reflect the difference between groundwater and surface water impact potential of different petroleum products such as gasoline, # 2 fuel oil or # 6 fuel oil nor do the proposed changes differentiate or give consideration to petroleum storage facilities over groundwater deep recharge areas as opposed to those in less sensitive hydrogeologic zones." (100, L35) Heavy oils. Re #5 and #6 fueloiltanks:" It is very expensive and timeconsuming to perform integrity tests on such tanks and because of the viscosity and pour point of these products, there is little likelihood that these products could flow and cause any substantial environmental damage." (54, L35) "In New York State, for example, the bulk storage regulations effectively exclude No. 6 fuel oil and other petroleum products for purposes of regulatory control." (100) "First, ..., an exclusion should be provided for tanks used to store oils with a pour point greater than 60 degrees Fahrenheit. Such tanks pose little risk to navigable waters because the oil does not flow freely. Moreover, the costs of cleaning and testing such tanks is extremely high because of the difficulty of removing oil from the tank." (125) Residual oil. "A ten­ year testing cycle is simply not justified for residual oil tanks. Such relatively frequent forced outages will likely impact system reliability in the context of maintaining reserve capacity requirements if, for example, a particular generating unit is supplied from a specific fuel oil tank or an alternative fuel is unavailable." (100) Clarification. "` Integrity testing' is not defined." (70) Frequency of testing. Construction material or usage. "The requirement of testing every ten years does not take into account construction materials, usage, or many other factors. It is suggested that more flexibility is warranted to address particular cases." (L30) Industry standards. "Also, the integrity test interval of 10 years for tanks with containment seems to conflict with API guidance recommending ultrasound thickness measurements within 5 years after commissioning new tanks and at 5 244 year intervals for existing tanks where the corrosion rate is not know." (16) "API suggests that adherence to accepted industry operating and inspection standards should also e accepted in place of the proposed 10 year integrity testing interval. In some cases industry standards provide more specificity, and in others, more stringent requirements that the proposed wording." (67) More frequent. The proposed rule "contains too long a period between AST integrity tests (10 years). EPA should develop an AST integrity testing schedule that provides for more frequent testing for older tanks with bottoms made of corrosive material." (44, 88) More limited. We should limit the required integrity testing frequency. (71) Material repairs. "However, to help clarify what constitute material repairs, §112.8( c)( 6) should be revised to indicate that such testing must be performed when the repairs involve the installation of a 12 inch or larger nozzle in the shell, a new steel bottom, a door sheet, tombstone replacement in the shell, or other similar repairs that could materially increase the potential for oil to be discharged from the tank." (83, 102) Method of testing. Other techniques. Between hydrostatic testing, we should allow owners or operators to use other inspection techniques while the tanks are in service. This approach would permit owners or operators to schedule tank outages while supporting supply and demand obligations. (25) Rule list. "Guidelines or recommendations for inspections and testing procedures should be set forth here." (27) "Unless you are prepared to state what type of `integrity testing' is acceptable to EPA, and to what standards, this paragraph should be deleted." (121) Visual inspection. Internal and external. "The seriousness of certain conditions such as tank bottom settlement, bottom corrosion, or poor condition of roof supports may not be identified by this type of `integrity testing'. EPA should consider requiring that integrity testing procedures be complemented with a formal internal visual inspection when the tank is not in service." (16) "It should be clarified if the extent of a visual inspection would be expected to be both inside and out (that is, product and vapors removed)." (76) Visual inspections adequate. "We support the need to review the integrity of tanks. We are not in favor of pressure testing and would be concerned with the amount of pressure applied. ... Visual inspection is much more economical and will be used as often as twice yearly where possible. Remote sites would be inspected at least yearly, with full time electronic monitoring used when possible." 245 (37) "A second exclusion should be provided for tanks that are capable of visible inspection on all sides and utilize secondary containment. In such a case, where the tank bottom as well as the sides can be adequately inspected, integrity testing is not necessary to maintain the safety of the tanks." (125) "The Company feels that visually inspecting aboveground tanks fully meets the intent of the testing requirement. During the aforementioned UST rulemaking in 1988, EPA totally exempted USTs which were in basements or vaults if the USTs were totally inspectable for leaks. EPA recognized that these tanks, although they were subterranean, did not require upgrading, release detection, etc., based upon the simple fact that they were inspectable and this was a reliable means of detecting leakage." (164) Response: Support for proposal. We appreciate commenter support. Applicability. Integrity testing is essential for all aboveground containers to help prevent discharges. Testing will show whether corrosion has reached a point where repairs or replacement of the container is needed. Prevention of discharges is preferable to cleaning them up afterwards. Therefore, it must apply to large and small containers, containers on and off the ground wherever located, and to containers storing any type of oil. From all of these containers there exists the possibility of discharge. Air emissions, fatalities. An owner or operator who follows good engineering practice will minimize the possibility of air emissions or fatalities. In any event, an owner or operator must comply with applicable State and Federal clean air and safety requirements. Ancillary equipment. We agree that integrity testing should include ancillary equipment in some circumstances, and require integrity and leak testing on a periodic basis for valves and piping when a facility lacks secondary containment. 40 CFR 112.7( d). Even with secondary containment, an owner or operator must examine all aboveground valves, piping, and appurtenances regularly to assess the general condition of certain items. 40 CFR 112.8( d)( 4). In addition, an owner or operator must conduct integrity and leak testing of buried piping at the time of installation, modification, construction, relocation, or replacement. 40 CFR 112.8( d)( 4) Electrical equipment. Because electrical, operating, manufacturing equipment are not bulk storage containers, the requirement is inapplicable to those devices or equipment. 56 FR 54623. See also the definition of bulk storage container in §112.2. Furthermore, as noted by commenters, methods may not exist for integrity testing of such devices or equipment. Hazardous waste. While it is possible that cleaning might generate more hazardous waste, that is not a reason to avoid integrity testing. The purpose of the testing is to prevent container failure leading to a discharge as described in §112.1( b). 246 Phase­ in. We disagree that there should be a phase­ in of the requirement because it is already in effect. Rust. A container with any potential to rust may fail and discharge oil. Further, rust is not the only possible failure factor. For example, integrity testing may reveal an improper weld or inadequate shell thickness before the defect causes a container to fail. Secondary containment. We disagree that secondary containment for the entire content of a container mitigates the need for integrity testing. Such testing helps prevent the discharge in the first place. Furthermore, oil may escape secondary containment and reach the environment. Business records. You may use usual and customary business records, at your option, for purposes of integrity testing recordkeeping. Specifically, you may use records maintained under API Standards 653 and 2610 for purposes of this section, if you choose. Other usual and customary business records either existing or to be developed in the future may also suffice. Or, you may elect to keep separate records for SPCC purposes. This section requires you to keep comparison records. Section 112.7( e) requires retention of these records for three years. You should note, however, that certain industry standards (for example, API Standards 570 and 653) may specify that an owner or operator to maintain records for longer than three years. Frequency of testing, industry standards, 10­ year integrity testing. Integrity testing is a necessary component of any good prevention plan. A number of commenters supported a requirement for such testing. It will help to prevent discharges by testing the strength and imperviousness of the container. We agree with commenters that testing according to industry standards is preferable, and thus will maintain the current standard of regularly scheduled testing instead of prescribing a particular period for testing. Industry standards may at times be more specific and more stringent than our proposed rule. For example, API Standard 653 provides specific criteria for internal inspection frequencies based on the calculated corrosion rate, rather than an arbitrary time period. API Standard 653 allows the aboveground storage tank (AST) owner or operator the flexibility to implement a number of options to identify and prevent problems which ultimately lead to a loss of tank integrity. It establishes a minimum and maximum interval between internal inspections. It requires an internal AST inspection when the estimated corrosion rate indicates the bottom will have corroded to 0.1 inches. Certain prevention measures taken to prevent a discharge from the tank bottom may affect this action level (thickness). Once this point has been reached, the owner or operator has to make a decision, depending on the future service and operating environment of the tank, to either replace the whole tank, line the bottom, add cathodic protection, replace the tank bottom with a new bottom, add a release prevention barrier, or some combination of the above. Another benefit from the use of industry standards is that they specify when and where specific tests may and may not be used. For example, API Standard 653 is very specific 247 as to when radiographic tests may be used and when a full hydrostatic test is required after shell repairs. Depending on shell material toughness and thickness a full hydrotest is required for certain shell repairs. Allowing a visual inspection in these cases risks a tank failure similar to the 1988 Floreffe, Pennsylvania event. Testing on a "regular schedule" means testing per industry standards or at a frequency sufficient to prevent discharges. Whatever schedule the PE selects must be documented in the Plan. Integrity testing. "Integrity testing" is any means to measure the strength (structural soundness) of the container shell, bottom, and/ or floor to contain oil and may include leak testing to determine whether the container will discharge oil. It includes, but is not limited to, testing foundations and supports of containers. Its scope includes both the inside and outside of the container. It also includes frequent observation of the outside of the container for signs of deterioration, leaks, or accumulation of oil inside diked areas. Material repairs. The rationale for testing at the time material repairs are conducted is that such repairs could materially increase the potential for oil to be discharged from the tank. Examples of such repairs include removing or replacing the annular plate ring; replacement of the container bottom; jacking of a container shell; installation of a 12­ inch or larger nozzle in the shell; a door sheet, tombstone replacement in the shell, or other shell repair; or, such repairs that might materially change the potential for oil to be discharged from the container. Method of testing. The rule requires visual testing in conjunction with another method of testing, because visual testing alone is normally insufficient to measure the integrity of a container. Visual testing alone might not detect problems which could lead to container failure. For example, studies of the 1988 Ashland oil spill suggest that the tank collapse resulted from a brittle fracture in the shell of the tank. Adequate fracture toughness of the base metal of existing tanks is an important consideration in discharge prevention, especially in cold weather. Although no definitive non­ destructive test exists for testing fracture toughness, had the tank been evaluated for brittle fracture, for example under API standard 653, and had the evaluation shown that the tank was at risk for brittle fracture, the owner or operator could have taken measures to repair or modify the tank's operation to prevent failure. List of procedures. We disagree that we should state in the rule ­­ not the preamble ­­ what integrity testing procedures we consider adequate. We list examples in the rule of possible types of testing, but those are merely examples. While we suggest testing according to industry standards, we realize those standards will not be appropriate for every facility. Where industry standards are inappropriate for a particular facility, the Professional Engineer must devise a standard of testing that is appropriate. We note, however, that a visual inspection must be combined with some other technique. Pressure testing. We note that we do not require pressure testing. 248 Routine inspections. We disagree that a routine inspection suffices for an integrity test. A routine inspection may be visual and may not test the tank sufficiently to meet the §112.8( c)( 6) integrity testing requirement. We also disagree that we should require integrity testing only when the inspector thinks there is a risk of discharge because such a standard is entirely subjective. Visual inspection. For certain smaller shop­ built containers in which internal corrosion poses minimal risk of failure; which are inspected at least monthly; and, for which all sides are visible (i. e., the container has no contact with the ground), visual inspection alone might suffice, subject to good engineering practice. In such case the owner or operator must explain in the Plan why visual integrity testing alone is sufficient, and provide equivalent environmental protection. 40 CFR 112.7( a)( 2). However, containers which are in contact with the ground must be evaluated for integrity in accordance with industry standards and good engineering practice. Internal and external. A visual inspection may be either solely external, or external and internal. The rule requires visual testing in conjunction with another method of testing, because visual testing alone is normally insufficient to measure the integrity of a container. Visual testing alone might not detect problems which could lead to container failure. XI ­ B( 7) Leakage ­ internal heating coils ­ §112.8( c)( 7) Background: In 1991, we proposed to redesignate §112.7( e)( 2)( vii) of the current rule as §112.8( c)( 7). The proposal would require the prevention of leakage through defective internal heating coils. In 1991, we also proposed a new recommendation that the retention systems be designed to hold the contents of an entire tank, be of sufficient size to contain a spill that may occur when the system is not being monitored or observed, or have fail­ safe oil leakage detectors. Comments: External heating system recommendation. "It would seem that the cost to install insulation, upgrade boilers, and pay for the extra energy consumption would be outlandish." (76) Internal heating coils, opposition to recommendation. "It is felt that aboveground piping can be easily inspected and maintained; and, with drainage at facilities routed to oily water separators or holding ponds, it is unnecessary to have leak proof galleys under aboveground piping. This would be redundant containment and encouraging this installation is economically unjustified." (25) "The recommendation that aboveground piping be placed into galleys that drain into the oil/ water separator is not necessary. Leaks in the aboveground piping can be mitigated through daily inspections and they are often placed within the secondary containment." (68) Instead of requiring a retention system, which would hold the entire contents of a tank, suggests, "A reasonable alternative would the installation of an oil/ water separator with a high product level indicator; or a flow­ stop valve which incorporates a valve that closes if a 249 liquid with a specific gravity of less than 1 is present (such as provided by Enquip of Tulsa)." (76) Oil/ water separators. "In addition, not all facilities have oil/ water separators and the same ought not to be a requirement. ... The choice of what type of equipment and requirements an operating facility need should be left to the regulated unit and the qualified independent professional engineer." (162) Response: Alternatives. The rule does not mandate the use of any specific separation or retention system. Any system that achieves the purpose of the rule is acceptable. That purpose is to prevent discharges as described in §112. 1( b) by controlling leakage. Proposed recommendation. We deleted the proposed recommendation from the rule because we do not wish to confuse the regulated public as to what is mandatory and what is discretionary. We have included only requirements in the rule. XI ­ B( 8) Good engineering practice ­ alarm systems ­ §112.8( c)( 8) Background: In 1991, we proposed to redesignate §112.7( e)( 2)( viii) of the current rule as §112.8( c)( 8). The provision pertains to engineering requirements formerly labeled "fail­ safe." Comments: Support for proposal. Supports proposed list of devices that we consider to be "fail­ safe" engineering. (143) Terminology. Objects to the term "fail­ safe" engineering because nothing is ever failsafe Suggests using term "in accordance with good engineering practice" or "consistent with accepted industry practices" instead. (54, 92) Applicability. "GM recommends that installation of fail­ safe equipment be required for storage tanks of volume greater than 100,000 gallons, and/ or for storage tanks that were the cause of a reportable spill within the past three years." (90) "If fail safe devices are appropriate for specific large tanks, the requirement should be phased in over a period of 2 to 5 years." (116) Alternatives. Procedures. Supports use of "procedures" as well as "devices" as good engineering practice measures. (54) Tanks filled "with an operator present should not require such devices." (116) UST rules. "With respect to overfill requirements, existing Underground Storage Tank (UST) regulations ... merely require a five (5) gallon overfill bucket ­ a standard feature for vaulted tanks. Overfill requirements, as contemplated by the proposed revised regulations, should not exceed the EPA standards for USTs." (50) 250 Monitoring. "... the `fast response system' for overfill prevention does not provide the same level of protection as a high level alarm or high liquid level pump cutoff. If this alternative is to be considered further by EPA, the regulations should require that a person be present to monitor gauges and the overall filling of storage tanks." (111) Response: Support for proposal. We appreciate commenter support. Terminology. We agree with the commenter that "fail­ safe" engineering is inappropriate and have substituted "in accordance with good engineering practice." The change in terminology does not imply any substantive change in the level of environmental protection required, it is merely editorial. Applicability. Alarm system devices are necessary for all facilities, large or small, to prevent discharges. Such systems alert the owner or operator to potential container overfills, which are a common cause of discharges. Because this is a requirement in the current rule, no phase­ in is necessary. Alternatives. Under the deviation provision at §112.7( a)( 2), you may substitute "procedures" or other measures that provide equivalent environmental protection as any of the alarm systems mandated in the rule if you can explain your reasons for nonconformance. Such procedures might include conformance to UST rules if you can show that such conformance provides equivalent environmental protection to the SPCC requirement. Monitoring. We agree with the commenter that a person must be present to monitor a fast response system to prevent overfills and have amended the rule accordingly. We disagree that the requirement for alarm devices should not apply when a person is present, because human error, negligence, on inattention may still occur in those cases, necessitating some kind of alarm device. XI ­ B( 9) Removal of accumulated oil within 72 hours ­ §112.8( c)( 10) Background: Section 112.7( e)( 2)( x) of the current rule requires an owner or operator of an onshore bulk storage facility to promptly correct visible oil leaks that result in a loss of oil from tank seams, gaskets, rivets, and bolts sufficiently large enough to cause the accumulation of oil in diked areas. In 1991, we reproposed this requirement in redesignated §112.8( c)( 10). We also proposed to require that an owner or operator completely remove accumulated oil or oil­ contaminated materials within 72 hours from the time the discharge occurred. We noted that this time frame was consistent with the requirement for diked areas in proposed §112.7( c), where we proposed to require that the entire containment system be impervious to oil for 72 hours. Comments: Bioremediation. "... the 72­ hour requirement would effectively limit the choice of cleanup technologies to those that emphasize speed. This would preclude the use of other proven technologies, such as in­ situ bioremediation, which cannot be completed in a 72­ hour period." (42, 48, 67, 91, 99, 102, 133, 175, 187). 251 "Bioremediation techniques and other measures which may be used under existing laws are less expensive and create less waste than removal procedures. No materials are transported, which eliminates the risks inherent in hauling the `contaminated' dirt. In short, fixing the problem `on the spot' is often very good advice." (42) 72­ hour cleanup standard. Support for proposal. "As noted in the preamble, such containment would have to be impervious to spilled product for 72 hours." (L17) Opposition to proposal. We should delete the requirement or change it to a recommendation. (72) Expensive. "To require total cleanup of spilled oil and material within 72 hours in all cases would be impractical, costly, and impossible in some cases." (22, 37, 72, 90, 99, 170, 187) The 72­ hour requirement is excessive and unnecessary because spill response procedures are described in the SPCC Plan. (25) The requirement would be particularly costly for remote facilities. (37) Health or safety hazard. "Depending on site conditions," 72 hour cleanup "could jeopardize worker safety and health." (48, 67, 91, 102, 170, 175, 187) Impractical or impossible. "To require total cleanup of spilled oil and material within 72 hours in all cases would be impractical, costly, and impossible in some cases." (22, 48, 57, 72, 83, 92, 98, 102, 107, 125, 143, 153, 170, 175, 184, 189, L2) Removal within 72 hours from the time of the spill would be difficult for unattended facilities. (72) Texas allows on­ site soil remediation or treatment. (99) "Frequently it is not technically feasible to remove contaminated soil due to structural concerns or volume considerations. State regulations often will not allow for treatment methods which are commonly employed until a permit has been issued, requiring considerably more time than 72 hours." (153) "The Company agrees that `accumulated oil' (i. e., free product) be cleaned out of a containment structure, however, `oil contaminated materials' should not be a concern. This could be construed to mean the walls and floor of a clay dike used for containment." (125,164) Land disposal problems. "Also, to dispose of a waste sometimes takes as much as two months while waste samples are laboratory tested, arrangements are made with a disposal facility, and State approval is obtained to ship the wastes off site. In many cases, the ideal location to hold the waste until shipment offsite is within the secondary containment area of the tank which experienced the spill." (92, 125) "To disallow any other method than complete removal of oil contaminated soil from diked areas in these circumstances serves no useful purpose. Moreover, it compounds landfill disposal capacity problems and diverts funds that could be more effectively used to address other more pressing environmental problems." (99, 187) 252 Low risk, historic spills. "More importantly, at older facilities there may be historically contaminated soil from past spills within diked areas. These soils pose no threat of `escape to surface waters. The requirement to clean up in these instances would be prohibitively expensive and would yield no benefit." (72, 164) Small spills. "... API believes clarification is needed with regard to cleanup of small discharges as opposed to larger discharges within the proposed 72 hour cleanup period." (67, 77, 91, 175, 187, L20) Unnecessary. It is unnecessary to remove all spilled oil within 72 hours if the containment system is designed to be impervious to oil for a longer period of time. (57) Since regulated facilities have secondary containment, discharged oil and oil­ contaminated materials would be contained. Therefore, the 72­ hour requirement is unnecessary. (107, 189) Prevention ­ plastic film. Covering soil with plastic film may be an acceptable method to prevent stormwater contamination during remediation. (99) Terms to clarify. Accumulated oil, oil­ contaminated materials. We should clarify the terms accumulated oil and oil­ contaminated materials. (57, 62, 125, 153) Asks for clarification of accumulated oil, because a slow leak or drip may result in the accumulation of a small puddle of oil in a large containment area with limited access. In this situation, the risk to employees may be greater than the risk to the environment. (62) Completely removed. We should clarify the term completely removed. (57) Spill event. Our reference to a spill event in §112.8( c)( 10) is inconsistent with the definition in §112.2( s). (29) Time calculations. "API notes that the time the spill occurred will not always be known. Therefore, any such requirement should be based on the time the spill is first discovered." (67, 72, 91, 92, 102, 153, 164, 175) Clarification needed. Questions how 72­ hour period will be calculated. (67, 79, 82, 85, 91, 92, 95, 102, 153, 164, 175) Time cleanup­ alternatives. Immediately. "Accumulated oil should be cleaned up immediately, and not within the 72 hours proposed." (27) 253 72 hours after observation. "GM recommends that accumulated oil of sufficient volume, i. e., greater than 50 gallons, in containment structures should be removed expediently but no longer than 72 hours after observation." (90, 153) As soon as possible. We should require that the owner or operator complete clean­ up operations as soon as "possible" or "practicable," or "after the spill is discovered." ( 48, 67, 83, 91, 102, 133, 143) Expeditiously. (48, 67, 85, 91, 95, 102, 117, 133, 143) Initiation within 72 hours. We should amend the proposed requirement to state that clean­ up efforts must begin within 72 hours or within a period of time sufficient to permit the clean­ up of oil before the containment system begins to leak. (57) "As suggested above, this requirement should be changed to allow that within 72 hours and/ or as soon as feasible a spill will be responded to and cleanup initiated in order to ensure that navigable waters are not impacted." (66, 98, 125, 170, 184,189, L2, L20) We should require the "prompt removal of precipitation from containment areas" within 72 hours. We should require treatment of the accumulated precipitation from the containment areas, if necessary, within 72 hours after the precipitation had ended. (80) So as to prevent further environmental impact. "EPA should clarify this requirement to state that `accumulated spills should be sufficiently removed within 72 hours so as to prevent further environmental impact." (107) More than 72 hours. "If the spilled oil is contained or controlled or is being remediated, then there should be additional time given for the response measures in process, especially if there are difficulties encountered in the cleanup." (22) "Nor is it necessary to remove all spilled oil within seventy­ two hours if the containment system is designed to be impervious to oil for a much longer period of time." (57, 66, 98, 125, 170, 184, 189, L2) 96 hours. "A 96 hour time frame would still meet the general intent of the rule buy allowing unattended weekend operation, but still provide adequate response time once the event is discovered without putting the facility in jeopardy of not complying with the regulations." (87) 144 hours, at least. "Alyeska recommends that EPA at least double this time requirement." (77) Response: Support for proposal. We appreciate commenter support. Applicability. The requirement to clean up accumulations of oil is applicable to all facilities, large and small. The size of the accumulation is irrelevant, as any accumulation may migrate to navigable waters or adjoining shorelines. The damage to the environment may be the same, depending on the amount discharged. 254 72­ hour cleanup standard. We have deleted the proposed 72­ hour cleanup standard because it would preclude bioremediation. We also agree that under certain circumstances, such a time limit might jeopardize worker safety and health. Therefore, we have maintained the current standard that visible discharges must be promptly removed. Prompt removal means beginning the clean­ up immediately after discovery of the discharge, or immediately after taking any action to prevent fire and explosion or other threats to worker health and safety. However, actions to prevent threats of fire or explosions may not be used to unreasonably delay such efforts. The size of the accumulation is irrelevant, as any accumulation may migrate to navigable waters or adjoining shorelines. Extent of and methods of cleanup. No matter what method of clean­ up method you use, you must completely remove the accumulated oil. Any effective method that complies with all other applicable laws and regulations is acceptable. Bioremediation may be one acceptable method of clean­ up. Acceptable methods will depend on the weather, other environmental conditions, and good engineering practice. If the clean­ up method chosen undermines the stability of a dike, the owner or operator must repair the dike to its previous condition. Prevention ­ plastic film. We support all efforts to prevent contamination of navigable waters. An owner or operator may choose to spread plastic film over the diked area to prevent stormwater contamination, or use some other acceptable method. However, the owner or operator must dispose of the film properly if he chooses that method. Terms to clarify. Accumulated oil, oil­ contaminated materials. An "accumulation of oil" means a discharge that causes a film or sheen or a sludge or emulsion in a diked area. See 40 CFR 110.3( b). The term "oil­ contaminated materials" is not used in the final rule, because oil must accumulate on something such as materials or soil. Therefore, the term is redundant. Instead, in the final rule we use the term "accumulation of oil", which includes anything on which the oil gathers or amasses within the diked area. Such accumulation may include oil­ contaminated soil or any other oil­ contaminated material within the diked area that impairs (i. e., decreases the capacity of) the secondary containment system. Completely removed. We no longer use the term "completely removed" in §112.8( c)( 10). The requirement to remove any accumulation of oil means cleanup of all such accumulations. Spill event. We have removed the term "spill event" from the proposed paragraph and note that we agree with the commenter who noted that the reference to a "spill event," or a "discharge as described in §112.1( b)," within a diked area is inconsistent with that concept. XI ­ B( 10) Mobile and portable containers ­ §112.8( c)( 11) 255 Background: Under §112.7( e)( 2)( xi) of the current rule, an owner or operator must locate mobile or portable containers so as to prevent spilled oil from reaching navigable waters. He must provide secondary containment for the largest single compartment or tank. He must locate his facility where it will not be subject to periodic flooding or washout. In 1991, we proposed to designate §112.7( e)( 2)( xi) of the current rule as §112.8( c)( 11), and to change the requirement for secondary containment to a recommendation. We also proposed to recommend, not require, that an owner or operator locate a mobile or portable oil storage container in an area not subject to periodic flooding or washout. Comments: Floods. "... portable tanks are not the only tanks which should be kept out of the flood plain. The recommendation should be extended to all new equipment." ( 111) Requirement or recommendation. "Tanks should be required to be located in areas not subject to flooding." (27) We should amend the rule to require locating mobile or portable containers to "prevent discharges from entering navigable waters." (67) Secondary containment ­ requirement or recommendation. Recommendation. We should place the secondary containment recommendation in another document. (121) "Secondary containment for mobile or portable tanks should be left as a recommendation. In addition, some basic security procedures and a contingency plan may be adequate for spill prevention and control from mobile and portable tanks. Further investigation into the spill history from these types of tanks should be conducted to assess the environmental threat from such tanks." (190) Time limits. "Mobile and portable tanks should be defined more clearly. Ohio EPA recommends defining such a tank as one which is in place on a contiguous property for 10 days or less." (27) Response: Floods. We deleted the proposed recommendation on siting of mobile containers in this rule because we do not wish to confuse the regulated public over what is mandatory and what is discretionary. These rules contain only mandatory requirements. Requirement or recommendation. We agree that the purpose of the rule is to prevent discharges from becoming discharges as described in §112.1( b). Therefore, in response to comment, we have modified the proposed rule to require positioning or locating mobile or portable containers to prevent "a discharge as described in §112.1( b)," rather than "oil discharges." "A discharge as described in §112.1( b)" is a more inclusive term, tracking the expanded scope of the amended CWA. Secondary containment. In response to comments, we have maintained the secondary containment requirement in the current rule because secondary containment is 256 necessary for mobile containers for the same reason that it is necessary for fixed containers; to prevent discharges from becoming discharges as described in §112.1( b). Secondary containment must also be designed so that there is ample freeboard for anticipated precipitation. We have therefore amended the rule on the suggestion of a commenter to provide for freeboard. We agree with the commenter that the amount of freeboard should be sufficient to contain a 25­ year storm event, but are not adopting that standard because of the difficulty and expense for some facilities in securing recent information concerning 25­ year, 24­ hour storm events at this time. Should that situation change, we will reconsider proposing such a standard in rule text. Freeboard sufficient to contain precipitation is freeboard according to industry standards, or in an amount that will avert a discharge as described in §112.1( b). Should secondary containment not be practicable, you may be able to deviate from the requirement under §112.7( d). We clarify that the secondary containment requirement relates to the capacity of the largest single compartment or container. Permanently manifolded tanks are tanks that are designed, installed, or operated in such a manner that the multiple containers function as a single storage unit. Containers that are permanently manifolded together may count as the "largest single compartment," as referenced in the rule. Time limits. We decline to place a time limitation in a definition of mobile or portable containers. Mobile or portable containers may be in place for more than ten days and still be mobile. Mobile containers that are in place for less than 10 days may still experience a discharge as described in §112.1( b). XI ­ C: Facility transfer operations, pumping, and facility process ­ §112.8( d) XI ­ C( 1) Buried piping ­ protective coatings and cathodic protection 112.8( d)( 1) Background: Section 112.7( e)( 3)( i) of the current rule requires an owner or operator to cathodically protect and provide protective wrapping and coating on all buried piping installations if soil conditions warrant. In 1991, we proposed to redesignate §112.7( e)( 3)( i) as §112.8( d)( 1). In that proposal we recommended that an owner or operator place all piping installations aboveground, where possible. We also proposed to require that an owner or operator cathodically protect and provide protective wrapping and coating on new or replaced buried piping, with an alternative option to comply with other corrosion protection standards for buried piping in 40 CFR part 280, the underground storage tank (UST) regulation. We proposed to continue to require that an owner or operator carefully inspect buried pipeline for deterioration if a pipeline section is exposed for any reason. We proposed that if an owner or operator finds corrosion damage, he must inspect the damage and take corrective action as indicated by the magnitude of damage. Finally, in the preamble, we encouraged owners or operators to place piping installations in leak­ proof galleys that feed into the facility's oil/ water separator. We 257 also proposed to recommend that buried piping installations comply to the extent applicable with all of the relevant part 280 provisions. Comments: Aboveground piping recommendation. Support for recommendation. All piping. Owners or operators should place all piping aboveground to help detect piping system problems before there is a discharge. (L1) New piping. We should revise §112.8( d)( 1) to recommend that owners or operators place all new piping aboveground, where appropriate. It would be "onerous, costly, and not necessarily protective of navigable waters" to move all existing buried lines aboveground. (67) Editorial suggestion. "The first sentence in proposed 40 CFR 112.8( d)( 1) should be properly reworded (i. e., remove `shall' to read, `It is recommended that all piping be placed aboveground, where possible." (79, 102) Opposition to recommendation. The recommendation is "a clear safety problem if followed as recommended by the agency. ... Above ground installations do not provide the requisite degree of worker safety, because of the tripping hazard, that Delhi seeks to attain." (34) Buried piping recommendation ­ part 280. Support for requirement. The rule should "require – rather than recommend, that buried piping comply with the corrosion protection provisions of 40 CFR part 280." (44, 121) Recommendations not followed. "Also, practices for integrity testing and for installation of pipes pursuant to 40 CFR 280 should be changed from `recommended' practices to `required' practices. Our experience is that recommendations without standards are not usually followed." (111) Corrosion protection. Support for proposal. Applying protective coating and cathodic protection on buried piping provides sufficient leak protection. (34) We cannot enforce the current requirement for protecting buried piping installations "if soil conditions warrant." (121) "MDE strongly supports amendments to" §112.8( d)( 1). (135, L17) Opposition to proposal. 258 Coating only. "New and replacement piping should include protective coating. Cathodic protection should be required only when soil conditions require it. Tests to determine the need for cathodic protection are very specific and should be used to identify those locations requiring the protection." (114) Ineffective. "Protective coating and cathodic protection will not prevent a discharge of oil to the environment in the event of a pipe fracture, nor will such protection be able to detect a leak if one occurs. The practice of using double walled pipe or secondary containment and product sensitivity leak detection for new installations is currently required by NJDEPE." (147) Keep current rule. An owner or operator should protect new buried piping "where soil conditions support the operation of a corrosion system and where there is a history of external buried piping corrosion that can be controlled by corrosion protection." (67, 85, 114, 143) Repairs. "EPA should clarify that only the section of the line undergoing repair must be retrofitted with this corrosion protection." It would be very costly to retrofit the entire line. (83, 88, 102) Coating only on replaced sections. "Placing cathodic protection on sections of replaced piping is unwieldy and not technically feasible because the cathodic protection requires considerable maintenance. Bethlehem endorses the use of cathodic protection when an entire pipeline is replaced and protective wrapping on all replaced sections of pipe." (88) Leak­ proof galleys. Our recommendation for owners or operators to install leak­ proof galleys under aboveground piping is redundant and economically unjustifiable, because owners or operators easily can inspect and maintain aboveground piping, and because aboveground piping is often placed within secondary containment that drains to oil/ water separators. (25, 68) Response: Support for proposal. We appreciate commenter support. Aboveground piping recommendation. While we have deleted the proposed recommendation from the rule text because we do not wish to confuse the regulated public over what is mandatory and what is discretionary, we still believe that piping should be placed aboveground whenever possible because such placement makes it easier to detect discharges. The decision to place piping aboveground might include consideration of safety and traffic factors. Buried piping recommendation ­ part 280. We have deleted the recommendation from the proposed rule that all buried piping installations comply to the extent practicable with 40 CFR part 280, because we are excluding recommendations from this rule to avoid confusion with what is mandatory and what is discretionary. Also, some buried piping 259 now subject to part 112 will be subject only to 40 CFR part 280 or a State program approved under 40 CFR part 281 under this rule. See §112.1( d)( 4). Corrosion protection. Based on EPA experience, we believe that all soil conditions warrant protection of new and replaced buried piping. EPA's cause of release study indicates that the operational piping portion of an underground storage tank system is twice as likely as the tank portion to be the source of a discharge. Piping failures are caused equally by poor workmanship and corrosion. Metal areas made active by threading have a high propensity to corrode if not coated and cathodically protected. See 53 FR 37082, 37127, September 23, 1988; and "Causes of Release from US Systems," September 1987, EPA 510­ R­ 92­ 702. If you decide to deviate from the requirement, for example, to provide an alternate means of protection other than coating or cathodic protection, you may do so, but must explain your reasons for nonconformance, and demonstrate that you are providing equivalent environmental protection. A deviation which seeks to avoid coating or cathodic protection, or some alternate means of buried piping protection, on the grounds that the soil is somehow incompatible with such measure( s), will not be acceptable to EPA. A "new" or "replaced" buried piping installation is one that is installed 30 days or more after the date of publication of this rule in the Federal Register. We have deleted the words "new" and "replaced" from the proposed language and substituted this specific date so the effective date is clearer to the regulated community. Under the current rule, you have an obligation to provide buried piping installations with protective wrapping and coating only if soil conditions warrant such measures. Under the revised rule, you must provide such wrapping and coating for new or replaced buried piping installations regardless of soil conditions. You should consult a corrosion professional before design, installation, or repair of any corrosion protection system. Any corrosion protection you provide should be installed according to relevant industry standards. When piping is replaced, you must protect from corrosion only the replaced section, although protection of the entire line whenever possible is preferable. Equipping only a small portion of piping with corrosion protection may accelerate corrosion rates on connected unprotected piping. While we agree that corrosion protection might not prevent all discharges from buried piping, it is an important measure because it will help to prevent most discharges. We disagree that we should require only protective coating and not cathodic protection. Protective coating and wrapping and cathodic protection provide the maximum feasible leak prevention technology. We note that no strategy can prevent all discharges from buried piping, but corrosion protection and coating will help prevent most discharges. Double­ walled piping. Double­ walled piping or secondary containment or sensitive leak detection for buried piping may be acceptable as a deviation from the requirements of this paragraph under §112.7( a)( 2) if you explain your reasons for nonconformance with 260 the requirement and show that the means you selected provides equivalent environmental protection to the requirement. However, we will not require such measures because we did not propose them. Leak­ proof galleys. We have not included such a recommendation in the final rule, because all final rule provisions are mandatory. XI ­ C( 2) Terminal connections ­ §112.8( d)( 2) Background: Section 112.7( e)( 3)( ii) of the current rule requires an owner or operator to cap or blank­ flange an oil pipeline terminal connection when it is not in service or is in standby service for an extended time. In 1991, we proposed to redesignate §112.7( e)( 3)( ii) as §112.8( d)( 2), and to clarify that "an extended time" is "six months or more." Comments: Support for proposal. "Consistency for determining when loading/ unloading connections must be securely capped or blank­ flanged will be promoted by specifying what constitutes `an extended time', and NJDEPE supports the specified time period of six months." (147) Opposition to proposal. The rule should be rewritten as follows: "When piping is not in service or is not in standby service...." "Typically piping that is in standby service is only needed in emergency situations or when there is an operational problem. ... It is not appropriate for this requirement to apply to standby piping, especially if the piping must be put into service quickly during an emergency to insure the safe operation of the facility." (67, 102) Response: We appreciate commenter support. We have decided to keep the current standard of requiring capping or blank­ flanging terminal connections when such piping is not in service or is in standby for an extended time in order to maintain flexibility for variable facilities and engineering conditions. We define "an extended time" in reference to industry standards or at a frequency sufficient to prevent discharges. We disagree with commenters that the requirement should not apply to piping that is not in standby service because some discharges may be caused by loading or unloading oil through the wrong piping or turning the wrong valve when the piping in question was actually out­ of­ service. Typically, piping that is in standby service is only needed in emergency situations or when there is an operational problem. In the rare situations when such piping is needed immediately, the owner or operator may remove the cap or blank­ flange to return the piping to service. XI ­ C( 3) Aboveground valves and piping; buried piping ­ §112.8( d)( 4). XI ­ C( 3)­ 1 Inspection of aboveground valves, piping, and appurtenances Background: Under §112.7( e)( 3)( iv) of the current rule (redesignated in the final rule as §112.8( d)( 4)), an owner or operator must regularly inspect all aboveground valves 261 and pipelines. Operating personnel must assess the general conditions of items, such as flange joints, expansion joints, valve glands and bodies, catch pans, pipeline supports, locked valves, and metal surfaces. In 1991, we proposed that examinations of aboveground valves and piping must be monthly, and must include appurtenances. In 1991, we recommended in §112.8( d)( 4) that all valves, pipes, and appurtenances conform to relevant industry codes, such as ASME standards. Comments: Applicability. Electrical equipment. "This requirement would impose an extremely heavy burden on the electric utility industry if maintained in the final rule. The utility industry has millions of pieces of equipment in tens of thousands of facilities that could be subject to the SPCC requirements, some in remote areas. It would be extremely time­ consuming and expensive to require that each of these be inspected monthly." (125) Large facilities. We should exempt from the monthly examination requirement, piping systems associated with large tanks with a storage capacity greater than 100,000 gallons. (90) Buried piping recommendation. Support for recommendation. "ACMS agrees that all buried piping should be tested as proposed." (51, 87, 107, 168) Requirement instead. "ATA believes that such testing is reasonable and in accordance with good engineering practices. In order to provide sufficient environmental protection and to minimize industry remediation costs, such testing should be required rather than recommended. Also, it should apply to all SPCCregulated facilities, not only large facilities (greater than 42, 000 gallons) as EPA has suggested." (87, 107, 168) Editorial suggestion. "All aboveground valves, piping and appurtenances in oil service should be visually inspected regularly, monthly or more frequently if necessary, and they shall be subject to an annual examination where possible." (143) Industry standards recommendation. "Similarly, proposed section 112.8( d)( 4) should require, rather than recommend, that all valves, pipes, and appurtenances conform to relevant industry codes." (44) "This is also the place to require that piping and fittings be manufactured and assembled to industry codes (which need to be listed) for all construction beginning after the effective date of this part." (121) Methods of inspection. 262 Pressure testing. "We agree that monthly visual examinations of aboveground piping may be sufficient. However, a more sophisticated method of heating should be required every three or four years, such as pressure testing." (27) Visual examinations. We should require periodic visual examinations "in accordance with accepted industry standards." (67, 83, 91, 102) Monthly inspection. Support for proposal. Support for the §112.8( d)( 4) proposed requirement for monthly examinations of aboveground valves, piping, and appurtenances. (27, 91) Large and small facilities. Our proposed monthly examination should be a requirement for large facilities, but a recommendation for small facilities. (135) Opposition to proposal. Costly. Monthly examinations require large facilities to commit financial and personnel resources. (77) Monthly examinations are too restrictive (155). Unjustified and expensive. (L30) Difficult. "GM believes that all aboveground valves, piping, and appurtenances should not be subject to mandatory monthly examinations .... GM believes that the owner should be provided the flexibility to periodically examine piping systems at a necessary frequency to insure leaks and failure conditions are not occurring. Failure of aboveground piping system are unlike underground systems where corrosion is the main cause. Aboveground piping and appurtenances failure are more often caused by accidental damage or vibrational fatigue." (90) Recommendation instead. "The Agency has not shown that this requirement is necessary to reduce any risk of discharge to navigable waters, and therefore this provision should remain as a `should' to allow for the exercise of good engineering practice." (125, 136, 143, 155, 189) "We suggest that proposed §§ 112.8( d)( 4) and (d)( 5) be recommendations instead of requirements for facilities that store more than 42, 000 gallons." (39) Unnecessary. We should delete the §112.8( d) requirements since they are unnecessary. They are unduly onerous, since discharges emanating during transfer operations would be properly contained according to the SPCC Plan for that facility. Monthly examinations are excessive, unnecessary, and expensive. (189, L30) Alternatives to monthly testing. 263 Every six months. "A six month examination period combined with an obligation by the operator to be alert for spills that could result from failure of pipes and appurtenances is a more reasonable and economic approach." (77) Owner/ operator discretion. The owner or operator should determine examination frequency. (90, 155) Quarterly. Examinations should be performed quarterly ­ not monthly ­ for exploration and production facilities. (114) "Large facilities can have thousands of valves and miles of pipe, and even visual inspections would be very time­ consuming and costly. Further, there is some question as to whether monthly inspections are warranted; the condition of piping and valves rarely changes significantly in one month." (175) System examinations. We should not require monthly examinations, but should require systems examinations with sufficient frequency to assure safe and proper maintenance and operations. (184) Clarification needed. We did not explain what the monthly aboveground examination would require. (77) Response: Support for proposal. We appreciate commenter support. Applicability. Inspection of aboveground valves, piping, and appurtenances must be a requirement to help prevent discharges. Such valves, piping, and appurtenances often are located outside of secondary containment systems, and often do not have double­ wall protection or some form of secondary containment themselves. Therefore, any discharge from such valves, piping, and appurtenances is more likely to become a discharge as described in §112.1( b). Examination of discharge reports from the Emergency Response Notification System (ERNS) show that discharges from such valves, piping, and appurtenances are much more common than catastrophic tank failure or discharges from tanks. Electrical equipment. The requirements of this paragraph do not apply to electrical utilities and other facilities with oil­ filled equipment because they are not bulk storage facilities. Exploration and production facilities. Regarding the comment that we should require inspections less frequently for exploration and production facilities, the point is moot. Section 112.8 excludes production facilities from its scope. Large facilities. The requirement must be applicable to large and small facilities covered by this section, because of the same threat of discharge. Editorial suggestion. We agree with a commenter that the rule applies only to "oil­ handling" piping and valves, not all such piping and valves, which may be unrelated 264 to oil activities. However, no change in rule text is necessary because the entire rule applies only to procedures, methods, or equipment that are involved with the storage or use of oil. Industry standards recommendation. We deleted from rule text the recommendation that all valves, pipes, and appurtenances conform to industry standards, because we do not wish to confuse the public with discretionary items in a mandatory rule, but we endorse its substance. However, we do endorse conforming with industry standards and codes because such conformance reflects the exercise of good engineering practice. Monthly inspection. The final rule maintains the current standard of "regular" inspections, on the suggestion of commenters who noted that at some remote sites monthly inspections are impractical, especially in harsh weather conditions. Furthermore, we agree with commenters that "regular" inspections are inspections conducted "in accordance with accepted industry standards," rather than the monthly proposed standard. You must include appurtenances in the inspection. Inspections may be either visual or by other means, including pressure testing. However, we do not require pressure testing or any other specific method. We agree that, subject to good engineering practice, pressure testing every three or four years may be warranted in addition to regular inspection of aboveground valves, piping, and appurtenances. However, we believe that regular inspection is sufficient to help prevent discharges and will not impose any additional requirements at this time. Aboveground leaks. In response to the comment that leaks from aboveground piping are discovered more quickly than from underground storage tanks, we note that leakage may occur from any piping. An owner or operator must inspect aboveground valves, piping, and appurtenances to prevent such leakage. Integrity testing. In response to the comment that integrity testing is impractical for piping systems associated with storage tanks designed to operate as a gravity system, we note that we did not propose testing of aboveground piping. In response to the comment that accidental damage or vibrational fatigue most often causes aboveground system failure, we note that these conditions may become apparent when the owner or operator inspects the general conditions of aboveground valves, piping, and appurtenances. Transfer operations. In response to the comment that changes emanating during transfer operations would be properly contained according to the SPCC Plan for that facility, we think this remark is unrelated to the utility of preventive testing and remediation. Proper containment is an effective control measure for an actual discharge. Visual inspections. Inspections may be either visual or by other means, including pressure testing. However, we do not require pressure testing or any other specific method. We think the inspection method is best left to good engineering practice. 265 XI ­ C( 3)­ 2 Integrity and leak testing of buried piping ­ §112.8( d)( 4) Background: Under current rule §112.7( e)( 3)( iv), an owner or operator must conduct periodic pressure testing for piping in areas where facility drainage is such that a failure might lead to a spill event. In 1991, we proposed to redesignate §112.7( e)( 3)( iv) as §112.8( d)( 4), and to delete the periodic pressure testing requirement from the rule. Instead, we proposed to recommend annual integrity and leak testing or monthly monitoring of buried piping following the requirements of 40 CFR part 280, the Underground Storage Tank (UST) regulations. We proposed to require that an owner or operator maintain testing or monitoring records for five years. Comments: Applicability. Double­ walled tanks and piping. The configuration of a vaulted tank is unsuitable for monthly examinations we proposed. "VAST (Vaulted aboveground storage tank) technology also requires that all fittings and pipes come out of the top of the tank, which eliminates the possibility of leaking from the valves, pipes, or fittings and significantly reduces the potential for corrosion." (65) Exterior tanks and piping systems in remote locations are secondarily contained and have low­ level alarms connected to an attended facility. (79) "An alternative would be to allow double walled underground piping or other means of secondary containment for the pipe itself to be exempt from annual testing requirements. This type of piping is one way of addressing providing secondary containment to meet RCRA standards." (87) Manned facilities, aboveground facilities, cathodically protected facilities. "... discretion should be applied to and exceptions from periodic buried pipe testing should be established for manned facilities, aboveground facilities, and cathodically protected facilities." (192) Support for recommendation. "This provides for maximum flexibility in the use of good engineering practices." (39, 48, 66, 72, 95, 102, 103, 116, 150, 161, 175, 188,192, L8, L29) Alternatives. 3 years. "Oxychem recommends integrity testing be required on underground piping every three years, unless failure data supports more frequent testing." (141) 3­ 4 years. "However, a more sophisticated method of heating should be required every three to four years, such as pressure testing. ... Frequency may be based on aquifer use." (27) 5 years. "The testing for underground piping should be conducted once every five years. This would be consistent with the requirements for aboveground piping systems." (L2, L20) 266 Owner/ operator discretion. "Integrity testing of buried tanks, piping and valves should be discretionary in all cases. Cites pollution risk of testing. (102, 136, 155, 175) Periodic testing. We could make part 112 more cost­ effective by requiring "periodic testing of existing piping under a reasonable compliance schedule" to provide additional safeguards without the risks and difficulties the proposed recommendation presented. (L35) Regular basis. We should require testing on a regular basis. (143) Small facilities. We should allow owners or operators of small facilities with secondary containment to use good engineering practice to determine the testing frequency. (10) We should allow small facilities the discretion to determine testing frequency, but require owners or operators of large facilities to conduct the monthly monitoring. (116, 182) When a line is exposed. "API believes that buried piping should be inspected for corrosion and necessary remedial action whenever a section of the line is exposed." (67, 91, L30) Opposition to recommendation. Costly. "It would be impractical and extremely costly for small facilities to implement the recommended integrity and leak testing." (34, 66, 115) Annual testing would interfere with essential facility operations. (77) The need to monitor buried piping systems monthly is costly and a significant administrative burden. (90, 188) Drawbacks. "There are a variety of drawbacks with performing pressure testing of piping systems more frequently than site­ specific conditions indicate are necessary. Pressure testing of such systems often results in the generation of waste materials and air emissions that otherwise would not have resulted." (102) "Performing annual integrity testing of pipes and valves could be detrimental to the life expectancy of the piping. When a hydrostatic integrity test is performed, the piping is often subjected to 1. 5 times its design pressure. Annual testing will very likely cause undue stress on the piping and can potentially lead to premature failure, and consequently, releases to the environment." (141, 175) Impractical for multiple sites. "However, monthly testing is not practical at the many sites we have, especially those sites which are not accessible in the winter. Our fuel piping is contained within a secondary enclosure. If a leak occurs, the product will be contained and drained into a containment area where it will be noticed. The tank system has been designed to prevent any contamination to the environment if a failure should occur." (37, 79) 267 Inaccurate predictor. "Additionally, all the test would show is that the piping is not leaking at that particular moment. It would not be an accurate predictor of the future integrity of the line." (34, 115) Non­ operational pipelines. "Similarly, the pipeline integrity testing program would be too onerous to impose on historic, non­ operational buried pipelines, the location of which are not know." (35 ) Other leak prevention instrumentation. "Requiring annual tests on buried piping would severely limit the facility's ability to receive feedstocks and deliver finished products. It should not be necessary for these proposed requirements taking into consideration the other leak prevention instrumentation that would sound alarms, shut off pumps, and automatically close valves to isolate sections of piping." (25) Piping age, size. "Integrity testing of underground pipes on an annual basis appears too stringent and should be scheduled to account for the age of the facility (as is the case of UST regulations.)" We should require "testing for buried piping on a schedule related to the age and size of the system, with greater frequencies for older and larger systems." (89, 95, 102, 197, L30) (L30) Requirement instead. "Annual integrity and leak testing of buried piping will not be conducted unless it is made a requirements." (27, 44, 51, 87, 107, 111, 168) "Additionally, given the relatively higher frequency of piping leaks compared to tank leaks, it is essential that facility owners or operators be required to conduct `annual integrity and leak testing of buried piping or monitor buried piping on a monthly basis, ..., a requirement similar to that in 40 CFR part 280." (44) We should change the proposed §112.8( d)( 4) recommendation to a requirement or delete it. (121) "Proposed 112.8( d)( 4) should be a requirement since piping often runs outside of secondary containment systems. Examination of ERNS data will reveal that spills from piping are much more common than catastrophic tank failures or leaks from tanks. Buried piping is not capable of being visually inspected on a periodic basis, and many facilities do conduct integrity or leak testing of buried piping on a regular basis." (168) "Because secondary containment would not affect underground spill pathways, annual testing should be required of all underground piping systems." (L1) Large facilities. "We agree with the SPCC Task Force that such provisions should be made mandatory for large facilities. Buried piping which is unprotected should be inspected annually regardless of facility size." (L17) Too restrictive. The proposed testing provision is too restrictive. (155) Coast Guard rules. The buried piping recommendation should be consistent with U. S. Coast Guard rules for testing piping. (143) 268 Length and nature of piping. It is impractical to conduct monthly monitoring of lengthy buried piping systems. (66) "UCC believes that this should not apply to piping less than ten feet or piping which conveys limited flow annually." (190) Methods of testing. Guidance needed. We did not provide guidance on the types of accepted integrity testing or define what constitutes a leak rate. (66, 80) Hydrostatic testing. Hydrostatic testing should include testing with the product and gases to achieve the required pressure. (143) Part 280. Part 280 test methods and monitoring techniques do not apply to all buried piping systems, such as large diameter piping, booster pumps, and valves and connections. (66) "Alyeska also is confused by the preamble's statement that integrity and leak testing follow 40 CFR part 280. However, there is no mention of 40 CFR part 280 in the proposed rule for integrity and leak testing." (77) Visual or hydrostatic testing adequate. "A more reasonable requirement would be to require annual integrity testing of buried piping. Further, a requirement that such testing be anything other than visual or hydrostatic is financially burdensome, and also costly in terms of manpower." (188, L18, L30) Oil­ handling piping. We should clarify that our proposed integrity and leak testing or monthly monitoring recommendation applies only to oil­ handling piping and equipment not all buried piping or other equipment unrelated to oil operations. (103) Recordkeeping. Opposes proposal. We should exempt ASTs from the recordkeeping requirement. (65) It is unreasonable to require a facility to keep records of a recommended practice (77). The recordkeeping requirement is costly and a significant administrative burden. (90) The five­ year recordkeeping requirement is overly burdensome and unnecessary. (189) The proposed requirement is unmanageable and we failed to show that it is necessary to reduce any reasonable risk of discharge to navigable waters. (125) Supports proposal. Supports the proposed requirement that an owner or operator maintain testing and monitoring records for five years. (L1) Separate document for recommendations. We should keep discretionary provisions in a separate guidance document. (27) Response: Support for proposal. We appreciate commenter support. 269 Buried piping. We have deleted the text of the proposed recommendation to conduct annual integrity and leak testing of buried piping or monitor buried piping on a monthly basis from the rule because we do not wish to confuse the regulated public over what is mandatory and what is discretionary. This rule contains only mandatory requirements. However, we continue to endorse the recommendation as a discretionary action, and suggest that you conduct such testing according to industry standards. We agree with a commenter that the proposed recommendation would apply only to oilhandling piping and valves, not all such piping and valves, which may be unrelated to oil activities. However, no change in rule text is necessary because the entire rule applies only to procedures, methods, or equipment that are involved with the storage or use of oil. In response to the commenter who urged that the proposed recommendation not apply to buried piping of less than 10 feet in length, we believe that any buried piping, regardless of length, may cause a discharge, and therefore should be tested. Double­ walled piping might be an acceptable alternative to integrity and leak testing or monthly monitoring. If you choose double­ walled piping as an alternative, you must explain your nonconformance with the rule requirements, and explain how double­ walled piping provides equivalent environmental protection. See 112.7( a)( 2). On the suggestion of commenters, we have modified the proposed recommendation for annual testing or monthly monitoring of buried piping into a requirement that you must only conduct integrity and leak testing of such piping at the time of installation, modification, construction, relocation, or replacement. We believe that when piping is exposed for any reason, integrity and leak testing of such exposed piping according to industry standards is appropriate because piping is visible at that point, and testing is easier because the piping is more accessible. The same commenters also recommended that unprotected underground piping be subject to engineering evaluations every five years, but we recommend such evaluations be conducted in accordance with industry standards to preserve flexibility in case the time frame changes with changing technology. Double­ walled or vaulted tanks. If you have vaulted containers, the requirement for integrity and leak testing of buried piping might be the subject of a deviation under §112.7( a)( 2) if those pipes, valves, and fittings come out of the top of the container and are not buried, or are encased in a double­ walled piping system and you thereby significantly reduce the potential for corrosion. Feedstocks. We disagree that buried piping testing, whether annual or otherwise, would limit the facility's ability to receive feedstocks and deliver finished products. The facility may schedule testing so as not to interfere with receipt of products. Large or small facilities. This requirement applies to facilities of any size because the risk of discharge is the same. Manned facilities, aboveground facilities, cathodically protected facilities. The requirement for integrity and leak testing applies only to buried piping. Therefore, aboveground piping, whether manned or not, is exempted. Piping cathodically 270 protected is likewise not exempt, but may be the subject for a deviation if you explain your reasons for nonconformance, and show that cathodic protection provides equivalent environmental protection to the requirement to conduct integrity and leak testing of buried piping when it is installed, modified, constructed, relocated, or replaced. Piping material or age. Good engineering practice would include consideration of these factors, as well as site conditions. Coast Guard rules. We disagree that our rules should necessarily be consistent with Coast Guard rules on buried piping testing. We regulate non­ transportation­ related facilities. Comparing these facilities with transportation­ related facilities under Coast Guard programs is inappropriate because of the differences in the types of facilities that EPA regulates. Cost. We disagree integrity and leak testing is burdensome or costly for small facilities, or that testing other than visual or hydrostatic testing is financially burdensome and costly in terms of manpower. We do not specify the method of such testing. You may use the least costly method that meets the requirements of the rule. Method of testing. We do not require pressure testing or any other specific method. While testing pursuant to standards following part 280 or a state program approved under part 281 is certainly acceptable, it is not required. Generally we recommend testing according to industry standards. Guidance. We suggest use of industry standards where appropriate. Recordkeeping. We agree that a five year period for recordkeeping is more than necessary, and instead require that records be kept for a maximum of three years. See §112.7( e). We disagree that ASTs should be exempt from the recordkeeping requirement. There is no deviation for recordkeeping if a requirement to keep records is applicable. If the owner or operator of a vaulted tank deviates from the requirement to test buried piping at the specified intervals, he must explain his reasons for nonconformance, and provide equivalent environmental protection. If the equivalent environmental protection provided requires tests or inspections, records of those tests or inspections must be maintained for three years. XI ­ C( 4) Vehicular traffic ­ §112.8( d)( 5) Background: Section 112.7( e)( 3)( v) of the current rule requires warning verbally or by appropriate signs for vehicular traffic granted entry into the facility to be sure that the vehicle, because of its size, will not endanger aboveground piping. In 1991, we proposed to redesignate the provision as §112.8( d)( 5), adding a recommendation that the owner or operator post weight restrictions, as applicable, to prevent damage to underground piping. 271 Comments: Support for proposal. "It seems that good engineering practices would exclude heavy equipment from crossing buried piping which does not have adequate cover to protect the pipe." (39, 48, 51, 53, 72, 102, 143, 147, 161, 168, L8). Alternatives. Additional structural protection. "MDE recommends that if a buried pipe must be placed across a thoroughfare, it should be installed with additional structural protection. Proper installation is preventative and is a better alternative over a sign. The vehicle weight restriction signs are not always needed." (135) Local building codes. "In virtually all cases, local building codes or other standards already address the issue of buried piping protection." (53) Location and marking. "This could result in weight limits being set low at some sites that access would be denied to the very vehicles which need access to make the facility economically viable ­ and which have driven over the same piping for a dozen or more years. ... Location and marking of such piping so that it could be temporarily protected, or avoided, would appear to be an acceptable alternate. While it could be argued that providing such protection or rerouting emergency equipment is not practical, it is at least as practical as expecting such equipment to comply with weight restriction signs!" (76) PE discretion. "This provision recommends the posting of vehicle weight restrictions. However, it would be preferable for EPA to require that a PE be involved in evaluating this question and that the PE's conclusions be documented and implemented." (43) Requirement, not recommendation. The rule "should require, rather than recommend, that vehicular weight restrictions be posted to prevent damage to underground piping." (44, 52) Rerouting. "Location and marking of such piping so that it could be temporarily protected, or avoided, would appear to be an acceptable alternate. While it could be argued that providing such protection or rerouting emergency equipment is not practical, it is at least as practical as expecting such equipment to comply with weight restriction signs!" (76) Applicability. Airports. The proposal is "unreasonable at airport facilities where some buried piping/ hydrant systems run under ramp surfaces. Posting of signs in such open areas would be impractical and impact operations." (107) 272 Large facilities. Recommendation should apply only "to large facilities because only large facilities will have the type of tanker trucks which would potentially damage underground piping." (34, 75, 182) Railroads. "This recommendation is overly broad. Railroads have a large amount of piping under track that is built to withstand maximum loads from vehicular traffic. It is unnecessary to require signs for such pipes. Furthermore, it would be costly to post signs wherever there is underground piping on railroad property." (57) Vaulted tanks. "Because VAST technology requires all openings and fittings to be placed at the top of the tank, and requires the dike in the form of a concrete vault to immediately encompass the secondary containment, the risk of damage from vehicular traffic has been significantly reduced, making the provisions in §112.8( d)( 5) unduly burdensome and costly to sites using VAST technology." (65) Costs. We failed to recognize the substantial costs to owners or operators of determining accurate weight restrictions. (76) Guidance. "...( U) nless further guidance is provided on the method of determining an acceptable weight limit, this item should be eliminated." (169) Response: Support for proposal. We appreciate commenter support. Applicability. The requirement to warn vehicular traffic so that no vehicle will endanger aboveground piping or other oil transfer operations applies to all facilities, large or small, because vehicular traffic may endanger aboveground piping or other transfer operations at all facilities. Warnings may include verbal warnings, signs, or marking and temporary protection of piping or equipment. No particular height restriction is incorporated into the rule. Rather, aboveground piping at any height must be protected from vehicular traffic unless the piping is so high that all vehicular traffic passes underneath the piping. In this case, or where the requirement is infeasible, you may be able to use the deviation provision in §112.7( a)( 2) if you explain your reasons for nonconformance and provide equivalent environmental protection. We have deleted the clause concerning the size of vehicles that may endanger piping or oil transfer operations because the owner or operator may not be able to determine precisely when the size or weight of a vehicle which would cause such endangerment. In response to commenters who suggested that the posting of signs is impractical and might impact operations, or would be very costly, we note that you may deviate from the requirement under §112.7( a)( 2) if you explain your reasons for nonconformance and provide equivalent environmental protection. Costs. Even though we did not include the recommendation in the final rule, we included the estimated costs of the proposal in our 1991 economic analysis. 273 New regulatory structure. We see no need for a new regulatory structure because buried piping is likely to be an appurtenance to a completely buried tank and as such, is likely to be regulated under 40 CFR part 280. If the piping is not of a completely buried tank, the appurtenance is likely covered by part 112 requirements. Therefore, a new regulatory structure is unnecessary. Weight restriction posting. We deleted the proposed recommendation concerning weight restrictions as it relates to underground piping from rule text, but still support it when appropriate. We include only mandatory items in this rule because we do not wish to confuse the regulated public as to what is mandatory and what is discretionary. We decline to make the recommendation a requirement because we believe the appropriate posting of weight restrictions should be a matter of good engineering practice. 274 Category XII: Onshore production facility Plan requirements XII ­ A: Production facilities (general requirements) ­ §112.9( a) Background: In 1991, we proposed to reorganize §112.7( e) of the current rule into four sections (§§ 112. 8, 112. 9, 112. 10, and 112. 11), based on facility type. We proposed §112.7( e)( 5) of the current rule as §112.9 in 1991. Comments: Cost. Section §112.9 of the proposed rule would result in an increased economic burden on owners or operators of production facilities – particularly small facilities with "stripper" wells. "For these wells, any substantial capital expense or increase in operating costs will very likely result in premature closure." (42, 67, 91, 101) Performance standards. "Arbitrary standards for onshore and offshore production facilities (40 CFR §§ 112. 9 and 112. 11) should be deleted and replaced by reasonable performance standards." (86) Reorganization of rule. "The requirements for oil production facilities should be consolidated with similar requirements for on­ shore facilities. The few differences between the two types of facilities could be handled on a call­ out basis. As §§ 112.8 and 112.9 are now written, they are similar but not identical. There appears to be no justification for the difference." (111) Response: Cost. EPA considered cost factors in finalizing the requirements in this rule. We believe that facilities in compliance with the current rule will incur minimal additional cost due to the revisions in this rule. Many of the provisions we proposed in 1991 that commenters believed were too costly were not finalized in the rule, In addition, in today's rule, we have provided flexibility in several ways. Furthermore, we are finalizing other provisions in this rule which will reduce burden in other ways and will exempt certain facilities from having to prepare a Plan. EPA has also prepared an assessment of the costs of rule compliance, which is discussed in part VI. F (Regulatory Flexibility Act) of today's preamble, and we have included the specific comments related to costs and our responses in relevant sections of this preamble. We agree that we should require performance standards in this regulation rather than prescriptive standards. Throughout the rule we generally allow for the application of industry standards where the standards are both specific and objective, and their application may reduce the risk of discharges to and impacts to the environment. We also permit the owner or operator greater flexibility by allowing the use of deviations under either §112.7( a)( 2) or (d). Performance standards. The final rule generally provides for use of performance standards rather than design standards. See §§ 112.7( a)( 2) and (d). Reorganization of rule. We generally agree that the current rule is adequate and effective in preventing discharges. We have reorganized the rule into subparts and sections based 275 on the type of oil stored or used and the type of facility for clarity and ease of use. The reorganization is not a substantive change. XII ­ B: Facility drainage ­ §112.9( b) (proposed as §112.9( c)) XII ­ B( 1) Diked storage area drainage ­ §112.9( b)( 1) Comments: Applicability. Urges a small facility exemption from this requirement because the recordkeeping involved was too burdensome. Editorial changes and clarifications. "The language in §112.9( c)( 1) stating `... where an accidental discharge of oil would have a reasonable possibility of reaching navigable waters.... ' does not agree with the wording in §112.1( b)( 1) stating `... which due to their location could reasonably be expected to discharge oil in quantities that may be harmful.... ' These sections should be made consistent." (154) "The requirement to have all drains closed on dikes around storage tanks might preclude engineering measures (stand pipes) designed to handle flow­ through conditions at water flood oil production operations, where large volumes of water may be directed to oil storage tanks if water discharge lines on oil­ water separators become plugged." (28, 31, 101, 165) Recordkeeping. The recordkeeping provisions in proposed §112.9( c)( 1) are overly burdensome and of little benefit. (28, 58) Small facilities. We should exclude small facilities from the recordkeeping requirements. (58) Response: Applicability. We believe that this requirement must be applicable to both large and small facilities to help prevent discharges as described in §112. 1( b). The risk of such a discharge and the accompanying environmental damage may be harmful whether it comes from a large or small facility. We disagree that the recordkeeping is burdensome. If you are an NPDES permittee, you may use the stormwater drainage records required pursuant to 40 CFR 122.41( j)( 2) and 122.41( m)( 3) for SPCC purposes, thereby reducing the recordkeeping burden. Editorial changes and clarifications. In response to the commenter's suggestion, the reference to "navigable waters" becomes a reference to "a discharge as described in §112.1( b)." "Central treating stations" becomes "separation and treating areas." Such areas might be centrally located or located elsewhere at the facility and might include both separation and treatment devices and equipment. The reference to "rainwater is being drained" becomes "draining uncontaminated rainwater." We clarify that accumulated oil on rainwater must be disposed of in accord with "legally approved methods," not "approved methods." Alternatives. We should modify proposed §112.9( c)( 1), allowing owners or operators to recycle accumulated oil on the rainwater by other methods. This modification would allow flexibility to seek alternate, environmentally sound recycling methods. (L12) 276 Engineering methods. "Equivalent" measures referenced in the rule might, depending on good engineering practice, include using structures such as stand pipes designed to handle flow­ through conditions at water flood oil production operations, where large volumes of water may be directed to oil storage tanks if water discharge lines on oil­ water separators become plugged. Any alternate measures must provide environmental protection equivalent to the rule requirement. Industry standards. Industry standards that may assist an owner or operator with facility drainage include API Recommended Practice 51, "Onshore and Oil and Gas Production Practices for Protection of the Environment." Recordkeeping. We agree that a five­ year record retention period is longer than necessary and have deleted the proposed requirement in favor of the general requirement in §112.7( e) to maintain records for three years. However, this requirement must apply to both large and small facilities to help prevent discharges as described in §112. 1( b). The risk of such a discharge and the accompanying environmental damage from a small facility may be as harmful as from a large facility. If you keep stormwater drainage records required pursuant to 40 CFR 122.41( j)( 2) and 122.41( m)( 3), you may use such records for SPCC purposes, thereby reducing the recordkeeping burden. XII ­ B( 2): Drainage ditches, accumulations of oil ­ §112.9( b)( 2) (proposed as §112.9( c)( 2)) Background: Under §112.7( e)( 5)( ii)( B) of the current rule, an owner or operator of an onshore production facility must inspect and remove accumulations of oil from field drainage ditches, oil traps, sumps, or skimmers. In 1991, we proposed to redesignate §112.7( e)( 5)( ii)( B) as §112.9( c)( 2), and to require the owner or operator to remove oilcontaminated soils as well as accumulated oil within 72 hours, if immediate removal was not feasible. We solicited comments on the appropriate amount of time for discovery and removal of accumulated oil, recognizing that production facilities may not be staffed during a given 72­ hour period. Comments: Authority. EPA lacks CWA authority for this provision. CWA addresses clean water, not "clean dirt." (28, 58) Clarifications ­ "accumulation," "oil­ contaminated soil." We should clarify the terms accumulation and oil­ contaminated soil in the context of the proposed requirement to remove accumulated oil or oil­ contaminated materials within 72 hours. (28, 58, 71, 101, 153) Inspection schedule. "Field drainage ditches, etc., should have a schedule set for inspection of accumulations of oil. OHIO EPA recommends monthly inspections, and within 24­ hours of a 25­ year storm event." (27) 277 72­ hour cleanup standard. Opposition to proposal. Bioremediation. "Accumulated oil should be picked up and properly hauled. However, problems associated with oil­ contaminated soil can often be addressed as well or better if the material is left in place. Bioremediation techniques and other measures which may be used under existing laws are less expensive and create less waste than removal procedures." Proposal may limit bioremediation or other cleanup techniques. Clean up should be allowed in accordance with State and local requirements. (31, 67, 86, 90, 91, 99, 101, 144,145, 160, 167, 173) Costly. "Landfill space is at a premium and on­ site bioremediation has the potential to prevent environmental harm in a more cost effective manner with equivalent environmental results." (99, 101, 160) Impractical or impossible. "In addition, the 72­ hour requirement is unreasonable in many instances. In cases where a significant amount of oil has been released, or in remote locations, where it may be difficult to mobilize the equipment needed, or in snowy areas where leaks cannot be easily observed, it may be virtually impossible to complete cleanup within 72 hours." (31, 67, 71, 86, 91, 101, 153, 160, 167, 173, 175, 187, L12, L18) An owner or operator may be unable to obtain proper regulatory authorization to remove and dispose of oil­ contaminated soil within 72 hours. (31, 86, 153) Removal within 72 hours from the time of the spill would be difficult at an unattended facility. (102) Frequently, it is technically infeasible to remove contaminated soil because of "structural concerns" or the volume of soil. (153, 173) Some facilities have oil­ contaminated soil from past spills. (162) Landfill disposal problems. The requirement to remove all oil­ contaminated soil could compound landfill disposal capacity problems. (99, 165, L15) Navigable waters. We should require the owner or operator to remove the accumulation of oil only if that oil might reach navigable waters. (L12) Safety or health problems. The 72­ hour requirement could pose a safety or health hazard to employees. (102) Unnecessary. The 72­ hour requirement would be excessive and unnecessary because spill response procedures already must be described in the SPCC Plan. (31, 86) It is unnecessary to remove all spilled oil within 72 hours if the containment system is designed to be impervious to oil for a longer period of time. (71) 278 Time calculations. Discovery. Since the time when the spill occurred may be unknown, any time frame for removing oil or oil­ contaminated materials should be based on when the spill is discovered. (67, 71, 91, 102, 133, 153, 167, 173) 72­ hour cleanup standard ­ suggested alternatives. As soon as practical. We should require that the owner or operator complete clean­ up operations "as soon as practical" or "within a timely manner," or "after the spill is discovered." (78, 101, 102, 133, 153, 167, 173, 187) Immediately upon discovery. We should revise the proposal to require that cleanup operations begin immediately upon discovery of a spill, and that every reasonable effort be made to complete the clean­ up within 72 hours. (153) Initiation within 72 hours. We should require the initiation of remedial activities to begin within 72 hours from when the spill occurred. (18) Precautions. "During remediation operations, precautions are taken to prevent contamination of surface water by stormwater runoff. A dike or ditch may be constructed around the area, or oil absorbent materials may be placed around the area. Covering with plastic film is another acceptable means to temporarily prevent stormwater contamination during remediation operations." (99) Response: Authority. We have adequate authority to require cleanup of an accumulation of oil, including on soil and other materials, because section 311( j)( 1)( C) of the CWA provides EPA with the authority to establish procedures, methods, and equipment and other requirements for equipment to prevent discharges of oil. The broad definition of "oil" under CWA section 311( a)( 1) covers "oil refuse" and "oil mixed with wastes other than dredged spoil." If field drainage systems allow the accumulation of oil on the soil or other materials at the onshore facility and that oil threatens navigable water or adjoining shorelines, then EPA has authority to establish a method or procedure, i. e., the removal of oil contaminated soil, to prevent that oil from becoming a discharge as described in §112.1( b). The cleanup standard under this paragraph requires the complete removal of the contaminated oil, soil, or other materials, either by removal, or by bioremediation, or in any other effective, environmentally sound manner. Clarifications ­ "accumulation," "oil­ contaminated soil." Accumulation. We retain the term "accumulation of oil," but elaborate on its meaning. "Accumulation of oil" means a discharge that causes a "film or sheen" within the field drainage system, or causes a sludge or emulsion there (see 40 CFR 110.3( b)). An accumulation of oil includes anything on which the oil gathers or amasses within the field drainage system. An accumulation of oil may include oilcontaminated soil or any other oil­ contaminated material within the field drainage 279 system. See also the discussion of "accumulation of oil" included with the response to comments of §112.8( c)( 10). Oil­ contaminated soil. We eliminated the term "oil­ contaminated soil" because oil must accumulate on something, such as materials or soil. Inspection schedule. We have retained the "regularly scheduled intervals" standard for inspections. This standard means regular inspections according to industry standards or on a schedule sufficient to prevent a discharge as described in §112.1( b). Whatever schedule for inspections is selected must be documented in the Plan. We decline to specify a specific interval because such an interval might become obsolete with changing technology. 72­ hour cleanup standard. We agree that the 72­ hour cleanup standard might preclude bioremediation and have therefore deleted it. Instead we establish a standard of "prompt cleanup." "Prompt" cleanup means beginning the cleanup immediately after discovery of the discharge or immediately after any actions necessary to prevent fire or explosion or other imminent threats to worker health and safety. Precautions. We note that an owner or operator may choose to spread plastic film over the diked area to prevent the occurrence of an accumulation of oil. However, he must dispose of the film properly. XII ­ C: FEMA requirements ­ proposed §112.9( c)( 3) Comments for this section are addressed in Subcategory XVI­ B: State programs, SARA Title III, wellhead protection, flood­ related requirements, OSHA, and industry standards. XII ­ D: Production facilities ­ bulk storage containers ­ §112.9( c) (proposed §112.9( d)) XII ­ D( 1) Material and construction ­ §112.9( c)( 1) Background: Section 112.7( e)( 5)( iii)( A) of the current rule provides that for an onshore production facility, tanks should not be used for storing oil unless the tank material and construction are compatible with the material stored and the storage conditions. In 1991, we proposed to redesignate the current rule provision as §112.9( d)( 1), and to recommend that tank construction and operation conform to relevant industry standards because applying these standards reflects good engineering practice. Comments: Local standards. "OOGA seeks clarification that USEPA recognizes that local standards sometimes control industry standards on certain issues and that such could occur under this provision." (58) Recommendation v. requirement. `Proposed section 112.9( d) should require, rather than recommend, that tanks meet industry standards. At a date certain, all existing tanks 280 should be upgraded to meet industry standards. Moreover, all new and reconstructed tanks should be subject to applicable codes." (44) Response: Recommendation v. requirement. We are retaining the mandatory requirement to use no container for the storage of oil unless its material and construction are compatible with the material stored and the conditions of storage, as proposed. We have deleted the recommendation that materials, installation, and use of new tanks conform with relevant portions of industry standards because we do not wish to confuse the regulated public over what is mandatory and what is discretionary. However, we endorse its substance. In most cases good engineering practice and liability concerns will prompt the use of industry standards. See §112.3( d)( 1)( iii). In addition, a requirement is not necessary or desirable because local governmental standards on construction, materials, and installation sometimes control industry standards on these matters. XII ­ D( 2) Secondary containment ­ §112.9( c)( 2) Background: In 1991, we proposed in §112.9( d)( 2) (redesignated as §112.9( c)( 2) in the final rule) (§ 112.7( e)( 5)( iii)( B) of the current rule) to clarify that required secondary containment must include sufficient freeboard for precipitation. We also reproposed the requirement to confine drainage from undiked areas. Comments: Applicability. Oil leases. The proposal is "is too vague and comprehensive to be applied to oil leases. It would be applicable to entire leases covering hundreds of acres if interpreted improperly." (31, 101, 165, L15) Clarification. Accumulation. "Is accumulated oil and contaminated soil to be removed from diked areas under this provision? What is contaminated soil? What are the cleanup standards under this provision? What is an `accumulation'." (58) Methods. We should not allow alternate secondary containment systems such as those outlined in §112.7( c)( 1) of this part. (121) NPDES rules. "The new EPA NPDES storm water program clearly and very thoroughly regulates potential precipitation­ drainage related pollution from these sources. The requirements in this sentence amount to a duplicative regulatory requirement by the same agency." (28, 101, L12) Sufficient freeboard. We do not set a standard for "sufficient" freeboard. The owner, operator, or Professional Engineer (PE) should be able to determine the appropriate size for secondary containment on a site­ by­ site basis. (75) 281 Response: Applicability. The requirement applies to oil leases of any size. Secondary containment is not required for the entire leased area, merely for the contents of the largest single container in the tank battery, separation, and treating facility installation, with sufficient freeboard to contain precipitation. Clarification. Accumulation. We retain the term "accumulation of oil," but elaborate on its meaning. "Accumulation of oil" means a discharge that causes a "film or sheen" within the field drainage system, or causes a sludge or emulsion there (see 40 CFR 110.3( b)). An accumulation of oil includes anything on which the oil gathers or amasses within the field drainage system. An accumulation of oil may include oilcontaminated soil or any other oil­ contaminated material within the field drainage system. See also the discussion of "accumulation of oil" included with the response to comments of §112.8( c)( 10). Methods. We disagree that we should not allow alternate secondary containment systems such as those in §112.7( c)( 1). We note that no single design or operational standard is appropriate for all onshore production facilities. An owner or operator must choose the appropriate secondary containment system compatible with good engineering practice. NPDES rules. We deleted the proposed reference to undiked areas "showing a potential for contamination" because drainage from any undiked area poses a threat of contamination. When drainage from such areas is covered by storm water discharge permits, that part of the BMP might be usable for SPCC purposes. There is no redundancy in recordkeeping requirements, because you can use your NPDES records for SPCC purposes. Sufficient freeboard. In response to the comment as to how an owner or operator might determine how much freeboard is sufficient, we have revised the rule to provide that freeboard sufficient to contain precipitation is the standard. We have recommended a standard for sufficient freeboard in the final rule. That standard is sufficient freeboard to contain a 25­ year, 24­ hour storm event. However, because of the difficulty and cost of securing recent information concerning such events, we are not making this a rule standard. XII ­ D( 3): Container inspection ­ §112.9( c)( 3) Background: Section 112.7( e)( 5)( iii)( C) of the current rule provides that production tanks must be visually inspected on a periodic schedule and the foundation and supports of aboveground tanks must be inspected for deterioration. In 1991, we proposed to designate §112.7( e)( 5)( iii)( C) as §112.9( d)( 3) (redesignated as §112.9( c)( 3) in the final rule) and to require tank examinations at least once a year. We also proposed that an owner or operator keep schedules and records of examinations for the last five years, regardless of change in ownership. 282 Comments: Extent of inspection. Visual inspections. "It is not practicable to internally visually examine tanks on an annual basis due to the number that would need to be taken out of service at any one time to meet the requirement. API agrees with scheduled visual external examinations of tanks but believes that internal examinations and inspections should be accomplished in accordance with API Recommended Practice 12R1." (67, 85, 167) Frequency of inspection. Support for proposal. "Ohio EPA agrees with the provision for annual inspections of tank batteries, and with the requirement to keep the record of inspection for five years." (27) More frequent inspections. We should direct owners or operators to examine production tanks quarterly. (121) Opposition to proposal. "Requiring an annual tank inspection and record maintenance is an unnecessary expense. " (101) "If possible." We should require examining a tank's aboveground foundation and supports only "if practical" or "if possible." An owner or operator might be unable to inspect a tank where the foundation settled or there is a lack of space. (67, 173) Triennial inspection. Documenting an annual inspection would increase paperwork with no benefit to small facilities. The existing provision is adequate. "More importantly, the three year review of the SPCC Plan pursuant to section 112.5( b) is more than sufficient to document a visual inspection of the facilities." (58, 70) Record maintenance. Opposition to proposal. "OOGA is uncertain of the recordkeeping requirement under this provision. Undeniably, owners of crude oil production facilities routinely inspect their storage tanks. To document these inspections seems to serve no useful purpose." (58, 70) "The agency does not indicate a reason for increasing the records­ retention requirement from three to five years. Most if not all CWA related programs have a mandatory three­ year records retention requirement. EPA needs to explain their reason( s) for the more costly five­ year mandatory requirement. This request is made for every EPA mandatory five­ year record retention requirement in this proposed rule." (L12) PE Certification. "Regular inspections and record maintenance provisions should not require the certification of a Registered Professional Engineer, which is one possible interpretation of these requirements, as records are included in the Plan." (101, 165, L15) 283 Phase­ in. The rule should provide for a two­ year phase­ in period so that the facility will have the required five years of records. (102) Response: Extent of inspection. We disagree that the inspection of containers should be limited to external inspection. Internal inspection is also necessary to detect possible flaws that could cause a discharge. The inspection must also include foundations and supports that are on or above the surface of the ground. If for some reason it is not practicable to inspect the foundations and supports, you may deviate from the requirement under §112.7( a)( 2), if you explain your rationale for nonconformance and provide equivalent environmental protection. API standards. Regarding the comment that we should require internal examinations and inspections in accordance with an API practice, we note that while API standards may be sufficient for many facilities, no single design or operational standard is appropriate for all non­ transportation­ related facilities. An owner or operator should choose the appropriate standard in the exercise of good engineering practice. Visual inspection. Visual examinations must be in accordance with §112.9( c)( 3) specifications, and must include the foundations and support of each container. Frequency of inspection. We have maintained the current standard for frequency of inspection because we agree that inspections in accordance with industry standards are necessary. Those standards may change with changing technology, therefore, a frequency of "periodically and upon a regular schedule" preserves maximum flexibility and upholds statutory intent. Owner/ operator discretion. We decline to give an owner or operator absolute discretion to inspect if practical or possible; instead we recommend inspection according to industry standards. Whatever frequency of inspection that is chosen must be noted in the Plan. Record maintenance. Recordkeeping is necessary to document compliance with the rule. We have deleted the proposed requirement to maintain records of these inspections for five years, irrespective of ownership, because it is redundant with the general requirement in §112.7( e) to maintain Plan records. Section 112.7( e) requires record maintenance for three years. However, you should note that certain industry standards (for example, API Standard 653 or API Recommended Practice 12R1) may specify that an owner or operator maintain records for longer than three years. PE Certification. We do not require a PE to certify inspection records because such records are not part of the Plan. XX ­ D( 4) Good engineering practice ­ tank batteries ­ §112.9( c)( 4) 284 Comments: Good engineering practice. "Proposed section 112.9( d)( 4) should contain a requirement for fail­ safe engineering of oil production facility tanks, just as onshore bulk storage is required to be fail­ safe engineered (see proposed section 112.8( c)( 8)), to avoid confusion among the regulated community and to improve spill prevention." (27, 44) Small facilities. "Single tanks with a capacity of 10, 000 gallons or less and facilities with a capacity of 40,000 gallons or less should be exempt from this section." (28, 101) Too expensive. "Engineering tanks into a `fail­ safe engineering condition' is prohibitively expensive and unnecessary as far as Appalachian production is concerned." (101) Vacuum protection. "Installation of vacuum protection on every tank could cost in excess of $100/ tank. We doubt this has been calculated in the potential fiscal impact of these proposals." (28, 31, 101, 165) Response: Good engineering practice. We agree with the commenter that we should retain this section as a requirement both to improve spill prevention and to avoid confusion among the regulated community because of the similar requirement for bulk storage containers at facilities other than production facilities. Therefore, there are no new costs. Nevertheless, we believe that the costs of these measures are not excessive for small or large facilities because you have flexibility as to which measures you use, and may choose the least expensive alternative listed in §112.9( c)( 4). For example, should vacuum protection be too costly, you are free to use another alternative. Furthermore, you may also deviate from the requirement under §112.7( a)( 2) if you can explain nonconformance and provide equivalent environmental protection by some other means. We revised the paragraph on vacuum protection to clarify that the rule addresses any type of transfer from the tank, not merely a pipeline run. Vacuum protection. We note that the rule does not require vacuum protection, merely consideration of its use. You may choose to use vacuum protection, another of the listed measures, or an alternative that provides equivalent environmental protection. XII ­ E: Facility transfer operations ­ §112.9( d) (proposed as §112.9( e)) Background: Current §112.7( e)( 5)( iv) provides requirements for facility transfer operations for onshore oil production facilities. In §112. 7( e)( 5)( iv)( A), an owner or operator is required to examine "periodically on a scheduled basis" all aboveground valves and pipelines. In §112.7( e)( 5)( iv)( B), an owner or operator is required to examine salt water disposal facilities "often." In §112. 7( e)( 5)( iv)( C), an owner or operator is required to have a program of flowlines maintenance for their production facilities and we list specific elements that the program must include, such as periodic examinations and adequate records, as appropriate for the individual facility. In 1991, we redesignated §112.7( e)( 5)( iv)( A)­( C) as §112.9( e)( 1)­( 3), and proposed several changes. In §112.9( e)( 1), we proposed requiring an owner or operator to examine aboveground valves and piping monthly, and to include examination schedules 285 and records in the Plan for five years. We did not propose any changes to §112.9( e)( 2). In §112.9( e)( 3), we maintained the requirement that an owner or operator have a flowlines maintenance program, but proposed recommending, rather than requiring, that he include in the flowlines maintenance program the specific elements that the current rule requires. We proposed to change this requirement to a recommendation because the circumstances of locations, staffing, and design vary between facilities. We also proposed changing the periodic examination requirement to a recommendation that an owner or operator examine flowlines monthly. XII ­ E( 1) ­ Inspection of aboveground valves and piping ­ §112.9( d)( 1) Comments: Editorial suggestion. The rule should be clarified that "only inspections related to transfer operations are intended by inserting `associated with transfer operations' between `piping' and `shall' in the first line of proposed 112.9( e)( 1)." (75) Frequency of inspection. Opposition to proposal. Burdensome. Such a requirement would be unreasonably burdensome. The condition of valves and piping does not change significantly within a month. (67, 91, 133, 173, 187, L18) Unwarranted. "( I) nformal, regular visual inspections, with no record keeping requirements" should continue. (67) Field personnel routinely notice and fix any oil leaks associated with aboveground valves and pipelines. (101) Monthly inspections of aboveground valves and pipelines "may not be warranted." (175) Suggested alternatives. Every 6 months. "The condition of valves and piping does not change significantly within a month's time. Therefore, a more appropriate formal inspection frequency with documentation requirements is semi­ annual. More informal, regular visual inspections, with no record keeping requirements should continue." (67, 91, 133, 173, 187, L18) Performance standard instead. "The inspections standard ... should be amended to reflect a performance standard instead of a prescribed monthly inspection.... A generalized performance standard should be included that requires a minimum inspection interval, such as annual inspection, which could be altered to meet specific facility conditions." (31, 86, 160) Recordkeeping. Opposition to proposal. The proposed record keeping requirement is unnecessary, of little value, and "prohibitively expensive." (28, 101) Well attendants check 286 Appalachian Basin well sites (including all aboveground piping, valves, joints, gauges, pipe supports, etc.) on a near­ daily basis, noting necessary repairs. Documenting monthly examinations is unnecessary and a "waste of limited resources and time." It is meaningless to keep records of inspections where no problems were found. (71) All facilities. We should delete the record keeping requirement for all facilities; documenting monthly visual inspections would drastically increase paperwork with no benefit for small facilities. (70) PE certification. We should not require PE approval of the owner's or operator's maintenance records, as these records are included in the Plan. (101, 165, L15) Small facilities. We should exempt small facility owners or operators from the requirement to include aboveground valve and pipeline examination schedules and records in the Plan for five years. (58, 86) Response: Editorial suggestion. We agree with the commenter and have changed the rule language to provide that §112.9( d)( 1) applies to "aboveground valves and piping associated with transfer operations." Frequency of inspections. We have retained the current inspection frequency of periodic inspections, but editorially changed it to "upon a regular schedule." Our decision accords with the comment which sought a performance standard instead of a prescribed monthly inspection. The standard of inspections "upon a regular schedule" means in accordance with industry standards or at a frequency sufficient to prevent discharges as described in §112.1( b). Whatever frequency of inspections is selected must be documented in the Plan. Recordkeeping. We agree that a five­ year record retention period is longer than necessary and have deleted the proposed requirement in favor of the general requirement in §112.7( e) to maintain records for three years. However, comparison records for compliance with certain industry standards may require an owner or operator to maintain records for longer than three years. PE certification. PE certification of these inspections and records is not required. Small facilities. We disagree that we should exempt either a large or small facility owner or operator from the requirement to include aboveground valve and pipeline examination schedules and records in the Plan because those records are needed to document compliance with the rule. XII ­ E( 2) Salt water disposal facilities ­ §112.9( d)( 2) Comments: Sudden change in temperature. "A sudden change of temperature" is a rather vague indicator of potential system upsets. This commenter assumes that the 287 Agency means a rather sudden `drop' (as in freezing temperatures) that could cause system upsets. This requirement needs further clarification." (187) Applicability. Salt water disposal facility examination requirement should not apply to storage facilities with de minimis amounts of oil. (28, 58, 101) Frequency of inspection. To be consistent with other proposed inspection frequencies, the inspection frequency of salt water disposal facilities should be quarterly, rather than weekly. (114) Response: Applicability. The rule applies to any regulated facility with salt water disposal if the potential exists to discharge oil in amounts that may be harmful, as defined in 40 CFR 110.3. This standard is necessary to protect the environment. Frequency of inspections. Inspections of these facilities must be conducted "often." "Often" means in accordance with industry standards, or more frequently, if as noted, conditions warrant. Whatever frequency of inspections chosen must be documented in the Plan. Sudden change in temperature. A sudden change in temperature means any abrupt change in temperature, either up or down, which could cause system upsets. XII­ E( 3) Flowlines maintenance ­ §112.9( d)( 3) Background: In 1991, in §112.7( e)( 3) (redesignated in the final rules as §112.9( d)( 3)), we maintained the requirement that an owner or operator have a flowlines maintenance program, but proposed recommending, rather than requiring the owner or operator to include in the flowlines maintenance program the specific elements that the current rule requires. We also changed the periodic examination requirement to a recommendation that owners or operators examine flowlines monthly. Comments: Applicability. Small facilities. Asks that we exempt small facilities from the flowlines maintenance program requirement. (58) Frequency of inspections. Opposition to proposal. We should delete the entire recommendation, and keep only the requirement that production facility owners or operators have a flowlines maintenance program. (121) Costly. It is cost­ prohibitive and impossible for owners or operators of Appalachian oil gathering line systems to provide corrosion protection for the bare steel pipe used in these systems. The "use of coated lines and cathodic protection is cost prohibitive." (28, 31, 101, 165, L15) 288 Impossible. "These oil gathering line systems are buried in colder parts of the Appalachian basin, and monthly inspection of them is thus not possible." (28, 31, 165, L15) Lack of manpower. Owners or operators do not have enough manpower to inspect flowlines monthly. (91, 133, 173) Unwarranted. "Unless a flowline is known to have problems, monthly inspections may not be warranted. Many production facilities are unmanned and the cumulative length of flowlines can be several miles, so the proposed monthly timeframe may be burdensome." (175) Suggested inspection alternatives. Periodic. "Periodic inspections based on engineering judgment and historical data are sufficient to detect any significant deterioration in flowline condition." (67, 85, 91, 160, 173, 175) Quarterly. (114) Semi­ annual. (L18) Annual. (133). Response: Applicability. A program of flowlines maintenance is necessary to prevent discharges both at large and small facilities. However, we have deleted the proposed recommendation regarding the specifics of the program from the rule. We took this action because we are not including recommendations in the rule in order not to confuse the public over what is mandatory and what is discretionary. This rule contains only mandatory requirements. Corrosion protection, flowlines replacement. While we have deleted the recommendation from rule text due to reasons explained above and therefore, the rule imposes no new costs, we recommend corrosion protection, we recommend corrosion protection, and flowlines replacement when necessary, because those measures help to prevent discharges as described in §112.1( b). Cost. We disagree that the cost of this requirement is excessive or impossible. We do not prescribe the specifics of the program and the owner or operator may use any program (not necessarily the most expensive) effective to maintain the flowlines and prevent a discharge as described in §112.1( b). The requirement is a current one and is necessary to prevent discharges as described in §112.1( b). Frequency of inspections. In the proposed recommendation we suggested that you conduct monthly inspections for a flowlines maintenance program. We now recommend that you conduct inspections either according to industry standards or at a frequency 289 sufficient to prevent a discharge as described in §112.1( b). Under §112.3( d)( 1)( iii), the Professional Engineer must certify that the Plan has been prepared in accordance with good engineering practice, including consideration of applicable industry standards. 290 Category XIII: Plan requirements for onshore drilling/ workover facilities ­ §112.10 Background: Under §112.7( e)( 6)( i) of the current rule, an onshore drilling and workover facility owner or operator must position or locate mobile drilling or workover equipment to prevent spilled oil from reaching navigable waters. Section 112.7( e)( 6)( ii) requires that, depending on location, it may be necessary to use catchment basins or diversion structures to intercept and contain spills of fuel, crude oil, or oily drilling fluids. Section 112. 7( e)( 6)( iii) requires the owner or operator install a blowout prevention (BOP) assembly and well control system before drilling below any casing string or during workover operations. In 1991, we redesignated §112.7( e)( 6)( i), (ii), and (iii) as §112. 10( b), (c), and (d), respectively. We proposed to add §112.10( a), which proposed that in addition to the specific spill prevention and containment procedures listed under §112.10, an onshore oil drilling and workover facility owner or operator must also address the general requirements listed in §112.7. Under proposed §112.10( b), an owner or operator would have to locate mobile drilling or workover equipment to prevent spilled oil discharges. Under proposed §112.10( c), we proposed that depending on the location, catchment basins or diversion structures may be necessary to intercept and contain spills of fuel, crude oil, or oily drilling fluids. Under proposed §112.10( d), we proposed to require that when necessary, before drilling below any casing string or during workover operations, an owner or operator install a blowout prevention assembly and well control system capable of controlling any wellhead pressure that may be encountered while that blowout assembly is on the well. Comments: Support for proposal. Section §112.10 requirements should include workover and drilling equipment, human activity is often associated with accidental releases. (27) §112.10( a). "Change to: `In addition to the specific spill prevention and containment procedures listed under this section, onshore oil drilling and workover facilities must also address the requirements listed under section 112.7 and paragraph 112.8( c)( 11) in the SPP. ' (Note: the caveat `excluding production facilities' should probably be removed from 112.8( c).)" (121) In §112.10( a), we should require an onshore oil drilling and workover facility owner or operator to "address the applicable general requirements." (128) Editorial suggestion. Asks for a definition of "onshore drilling and workover facilities." (154) §112.10( b) ­ We should require positioning or locating mobile drilling or workover facilities to prevent oil discharges. (121) "We are categorically opposed to this requirement. The mobile drilling and workover contractor has absolutely no control as to the location of the rig unit.... The contractor has no input as to the site design nor responsibility for its maintenance." (128) Section 112.10( b) is unnecessary because it duplicates Bureau of Land Management (BLM) and State regulatory programs. (167) We should change 291 §112.10( b) to clarify that an owner or operator must prevent spilled oil discharges to navigable water. (L12) §112.10( d) ­ The rule should be revised to provide that: "Well service jobs, such as installing a rod pumping unit, may not require a BOP assembly and associated well control system." "BOP are not now, and should not become, a requirement for all operations. Service jobs such as the change out of a rod pumping unit, or the batch treatment of a well with corrosion inhibitor are minimal risk operations and do not normally require the use of BOP systems. These service jobs are minimal risk because they can be performed with existing wellhead equipment in place. If any unexpected pressure is incurred during the service job, then existing valves can be utilized to control the pressure." (67, 91) Gauge negative. We should explain the term gauge negative. (110) Response: Support for proposal. We appreciate the commenter support. §112.10 ­ We disagree that an onshore oil drilling and workover facility owner or operator must address the §112.8( c)( 11) requirements for mobile or portable oil storage tanks unless he has such containers. Section 112.8( c)( 11) pertains only to onshore bulk storage containers (except production facilities). §112.10( a) ­ We also disagree that it is necessary to revise the rule to require compliance with applicable §112.7 general requirements because the owner or operator must address all general requirements in §112.7 and all specific requirements in subparts B or C, as appropriate, for the type of facility he owns or operates. If a requirement is not applicable, the owner or operator must explain in the Plan why. Editorial suggestion. The new definition for "production facility" in §112. 2 includes the procedures, methods, and equipment referenced in this section, making a definition of "onshore drilling and workover facilities" unnecessary. §112.10( b) ­ We agree with the commenter that the contractor is not normally responsible for site location, nor site design or maintenance. Such decisions are the responsibility of the facility owner or operator. The owner or operator of the facility has the responsibility to locate mobile equipment so as to prevent a discharge as described in §112.1( b). We disagree that we should change the word equipment to facilities in §112.10( b). A facility may include structures, piping, and equipment. This paragraph is directed to the threat of discharge from equipment. We have revised §112.10( b) to provide that an owner or operator must position or locate mobile drilling or workover equipment to prevent a discharge as described in §112.1( b), rather than to prevent spilled oil discharges, as proposed. A discharge as described in 292 §112.1( b) includes a discharge to navigable waters, adjoining shorelines, or affecting certain natural resources. We disagree that §112.10( b) duplicates BLM and State regulatory programs. The BLM program is not specifically directed to preventing discharges of oil, and to the extent it meets SPCC requirement, any documentation from it may be usable in an SPCC Plan. Likewise for documentation from State regulatory programs. §112.10( d) ­ Where BOP assembly is not necessary, as for certain routine service jobs, such as the installation of a rod pumping unit or the batch treatment of a well with corrosion inhibitor, the owner or operator may deviate from the requirement under §112.7( a)( 2), and explain its absence in the Plan. When BOP assembly is unnecessary because pressures are not great enough to cause a blowout, it is likewise unnecessary to provide equivalent environmental protection. Gauge negative. Gauge negative is the pressure condition in a wellbore that results when the pressure exerted by the hydrocarbon reservoir is less than the hydrostatic pressure exerted by the column of drilling fluid in the wellbore. A gauge negative condition will not give rise to a pressure imbalance likely to cause a blowout. See 56 FR 54625. 293 Category XIV: Requirements for offshore oil drilling, production , or workover facilities ­ §112.11 Background: Section §112.11 includes SPCC Plan requirements for an owner or operator of an offshore oil drilling, production, and workover facility. XIV ­ 1 General and specific requirements ­ §112.11( a) Comments: State rules. "This section should be deleted because current State spill prevention, water discharge, and hazardous material regulations adequately provide spill protection in inland water areas such as lakes, rivers, and wetlands." (128) Response: State rules. We disagree with the commenter that these rules are unnecessary because not every State has rules to protect offshore drilling, production, and workover facilities. While some States may have rules, some State rules may not be as stringent as the Federal rules. In any case, Congress has intended us to establish a nationwide Federal program to protect the environment from the dangers of discharges as described in §112. 1( b) posed by this class of facilities. Therefore, we have retained the section, as modified. We note, however, that if you have a State SPCC plan or other regulatory document acceptable to the Regional Administrator that meets all Federal SPCC requirements, you may use it as an SPCC Plan if you cross reference the State or other requirements to the Federal requirement. If it meets only some, but not all Federal SPCC requirements, you must supplement it so that it meets all of the SPCC requirements. XIV ­ 2 Definition reference; MMS jurisdiction ­ proposed §112.11( b) Background: In §112.7( e)( 7)( i) of the current rule, the term oil drilling, production, or workover facilities (offshore) is defined. In 1991, we redesignated §112.7( e)( 7)( i) as §112.11( b), and referenced the proposed §112.2 definition of offshore oil drilling, production, and workover facilities. The proposed rule also would have provided that a facility subject to the Operating Orders, notices, and regulations of the Minerals Management Service (MMS) is not subject to part 112. Comments: We should delete §112.11( b) because it is unnecessary. (121) Response: The proposed 1991 section referenced the definition of "offshore oil drilling, production, and workover facility," which is now encompassed within the definition of "production facility" in §112. 2. A new sentence would have referenced the exemption of facilities subject to Minerals Management Service (MMS) Operating Orders, notices, and regulations from the SPCC rule. MMS jurisdiction is outlined in Appendix B to part 112. Since none of the proposed language is mandatory, we have deleted it because we have included only mandates in this rule so as not to confuse the regulated public over what is required and what is discretionary. We received no substantive comments on this paragraph. 294 XIV ­ 3 Facility drainage ­ §112.11( b) (proposed as §112.11( c)) Background: In §112.7( e)( 7)( ii) of the current rule, requirements for oil drainage collection equipment are described. In 1991, we redesignated §112.7( e)( 7)( ii) as §112.11( c), and proposed to require removal of collected material from oil drainage "as often as necessary to prevent overflow, but not less than once a year." Comments: Removal of collected oil. We should delete the modification that owners or operators remove collected material at "least once a year," because the current requirement is sufficient. (31, 86) Response: Removal of collected oil. EPA agrees with the commenter's suggestion that the current rule is sufficient to prevent discharges as described in §112.1( b), and therefore we have deleted the "at least once a year" standard. You must remove collected oil as often as is necessary to prevent such discharges. XIV ­ 4 Sump systems ­ §112.11( c) (proposed as §112.11( d)) Background: Under §112.7( e)( 7)( iii) of the current rule, an owner or operator of a facility with a sump system to adequately size the sump and drains must have a spare pump or equivalent method available for removing liquid from the sump, and assure that oil does not escape. In 1991, we redesignated §112.7( e)( 7)( iii) as §112. 11( d) (redesignated in the final rule as §112.11( c)). We also proposed that the owner or operator must employ a monthly preventive maintenance inspection and testing program to assure reliable operation of the liquid removal system and pump start­ up device. Comments: Frequency of inspections. "Semi­ annual, instead of monthly inspection and testing of the liquid removal system would be preferable." (L18) Response: Frequency of inspections. We have retained the current rule language requiring a "regularly scheduled" preventive maintenance program because we believe that the frequency of maintenance should be in accordance with industry standards or frequently enough to prevent a discharge as described in §112.1( b). Whatever schedule is chosen must be documented in the Plan. XIV ­ 5 Corrosion protection ­ §112.11( g) (proposed as §112.11( h)) Background: Under §112.7( e)( 7)( vii) of the current rule, an owner or operator must equip tanks with suitable corrosion protection. In 1991, we redesignated §112.7( e)( 7)( vii) as §112.11( h) (redesignated in the final rule as §112.11( g)). We also recommended that an owner or operator follow the appropriate National Association of Corrosion Engineers standards for corrosion protection. 295 Comments: Industry standards. We should either delete the proposed recommendation or make it a requirement for new construction. (121) We should modify §112.11( h) to incorporate other industry recommended corrosion control practices, particularly STI standards. (140) Response: Industry standards. In response to the comment, we have deleted the recommendation because we do not wish to confuse the regulated community over what is mandatory and what is discretionary. These rules contain only mandatory requirements. We expect that facilities will follow industry standards for corrosion protection as well as other matters (see §112.3( d)( iii)), but decline to prescribe particular standards in the rule text because those standards are subject to change, and we will not incorporate a potentially obsolescent standard into the rules. XIV ­ 6 Pollution prevention system testing and inspection ­ §112.11( i) (proposed as §112.11( j)) Background: Under §112.7( e)( 7)( ix) of the current rule, an owner or operator must test and inspect pollution prevention equipment and systems periodically, commensurate with the complexity, conditions, and circumstances of the facility. In 1991, we proposed to redesignated §112.7( e)( 7)( ix) as §112.11( j) (redesignated in the final rule as §112.11( i)). We proposed to require that an owner or operator use simulated spill testing to test and inspect human and pollution control and countermeasure systems, unless he can demonstrate that another method provides equivalent protection. We also proposed requiring periodic testing and inspection of pollution prevention equipment at least monthly. Comments: Frequency of testing. "Simulation testing on a monthly basis is excessive." (42, L12) Annual response drills. MMS requires only annual spill response drills for outer continental shelf operations. "We suggest this is an adequate frequency. Requiring more frequent simulations would overburden facility operators unnecessarily." (75, L12) Recommendations instead. We should convert periodic reviewing, testing, and inspecting provisions from requirements to recommendations. We can not justify these provisions either economically or as benefits conferred on society. (42) Semi­ annual testing. "...( A) semi­ annual, instead of monthly, requirement for testing and inspection of pollution prevention equipment would be preferable." (L18) Response: Frequency of testing. We have retained the current requirement for testing on a "scheduled periodic basis" commensurate with conditions at the facility because we believe that testing should follow industry standards or be conducted at a frequency 296 sufficient enough to prevent a discharge as described in §112.1( b) rather than any prescribed time frame. Whatever frequency is chosen must be documented in the Plan. We disagree that we cannot justify the costs and benefits. This rule is necessary to ensure that systems that prevent discharges function properly. XIV ­ 7 Blowout prevention ­ §112.11( k) (proposed as §112.11( l)) Background: Under §112.7( e)( 7)( xi) of the current rule, before an owner or operator drills below any casing string and during workover operations, he must install a blowout prevention (BOP) assembly and well control system. Further, this BOP assembly and well control system must be capable of controlling any expected well­ head pressure while it is on the well. In 1991, we proposed to redesignate §112.7( e)( 7)( xi) as §112.11( l) (redesignated in the final rule as §112.11( k)), but otherwise reproposed without substantive change. Comments: Alternatives. "There are occasions where this is not warranted or impractical to implement." Exception should be made for drilling below conductor casing. (L12) Response: Alternatives. The question of whether blowout prevention is warranted or impractical or not for drilling below conductor casing is one of good engineering practice. Acceptable alternatives may be permissible under the rule permitting deviations (§ 112.7( a)( 2)) when the owner or operator states the reasons for nonconformance and provides equivalent environmental protection in another way. XIV ­ 8 Extraordinary well control measures ­ §112.11( m) Background: Under §112.7( e)( 7)( xii) of the current rule, an owner or operator must provide extraordinary well control measures in the event of an emergency. In 1991, we proposed to redesignate §112.7( e)( 7)( xii) as §112.11( m). We proposed to recommend – instead of to require – that an owner or operator provide extraordinary well control measures if emergency conditions occur (e. g., fire, loss of control). We also recommended varying the degree of control system redundancy with hazard exposure and probable failure consequences. Further, we recommended that an owner or operator include redundant or "fail close" valving in surface shut­ in systems. Comments: We should delete proposed §112.11( m) or make it a requirement. (121) Response: In response to comment, we have deleted the text of the recommendations from the rules because we do not wish to confuse the regulated community over what is mandatory and what is discretionary. However, we endorse its substance. This rule contains only mandatory requirements. XIV ­ 9 Piping; corrosion protection ­ §112.11( n) (proposed as §112.11( p)) 297 Background: In §112.7( e)( 7)( xvi) of the current rule, we require an owner or operator to protect from corrosion all piping appurtenant to the facility. In 1991, we proposed to redesignate §112.7( e)( 7)( xvi) as §112.11( p) (redesignated in the final rule as §112.11( n)), and proposed to retain the requirement. We also proposed to recommend – rather than to require – that the owner or operator discuss in the SPCC Plan the corrosion protection method used, such as protective coatings or cathodic protection. Comments: We should delete the recommendation that an owner or operator discuss the corrosion protection method used in the SPCC Plan. (121) Response: In response to comment, we have deleted the recommendation to discuss the method of corrosion protection, because it is surplus. In your SPCC Plan, you must discuss the method of corrosion protection you use. See 112.7( a)( 1). XIV ­ 10 Written instructions for contractors ­ proposed §112.11( s) Background: Under §112.7( e)( 7)( xiii) of the current rule, an owner or operator must prepare written instructions for contractors and subcontractors to follow whenever contract activities involve servicing a well or systems appurtenant to a well or pressure vessel. In 1991, we proposed to redesignate §112.7( e)( 7)( xiii) as §112. 11( s). We proposed to recommend – rather than require – that the owner or operator prepare written instructions for contractors or subcontractors to follow in such circumstances. Comments: Liability. "The regulations appear to mandate involvement and control by an operator over the activities of contractors who perform services on offshore facilities. This creates two very serious problems. First, the contractors are hired to perform special services. The contractor is able to do his work more safely if he is allowed to direct his own activities. Second, operators expose themselves to various types of liability by virtue of the degree of control exercised over contractors." (42) Requirement instead. We should continue to require – rather than recommend – that owners or operators prepare written instructions for on­ site contractors and subcontractors. (121) Response: We have deleted the proposed recommendation because we wish to avoid confusing the regulated community over what is mandatory and what is discretionary. This rule contains only mandatory requirements. 298 Category XV: Relationship to other programs of the rule XV­ A: UST­ part 112 Background: In 1991, we noted that a number of underground and aboveground oil storage tanks are subject to both the SPCC regulation (40 CFR part 112) and the underground storage tank (UST) regulation (40 CFR part 280). In §112.1( d)( 2)( i) and (ii), we proposed that the calculation of a facility's underground and aboveground storage capacity should not include USTs, as defined in §112.2( v). To avoid duplicative regulation, in §112.1( d)( 4), we proposed to exclude from SPCC regulation USTs subject to the technical requirements of 40 CFR part 280, reasoning that the UST program offered comparable environmental protection. We noted that USTs not subject to all of the technical requirements of the UST provisions would be subject to the SPCC requirements. We also noted that the SPCC program would still regulate tanks that are not completely buried, because tanks with exposed surfaces exhibit a greater potential to discharge oil into navigable waters and other surface waters. Comments: For comments on this issue, see section IV. B of this document. Response: See section IV. B of this document for response. XV ­ B: State programs, SARA Title III, wellhead protection, flood­ related requirements, OSHA, and industry standards ­ part 112 Background: In the preamble to the 1991 proposed rule, we discussed the relationship between the SPCC regulation and other programs, including State programs; the Superfund Amendments and Reauthorization Act (SARA) Title III or the Emergency Planning and Community Right­ to­ Know Act (EPCRA); State wellhead protection (WHP) programs under the Safe Drinking Water Act (SDWA); flood­ related requirements under Executive Order (EO) 11988, "Floodplain Management;" and the Occupational Safety and Health Act (OSHA). XV­ B­ 1 State programs Background: See section X. K of this document. Comments: For comments on State issues, see section X. K of this document. Response: For responses on State issues, see section X. K of this document. XV­ B­ 2 SARA Title III and wellhead protection Background: In 1991, we specified how coordination between Federal, State, and local agencies is possible through additional authorities – SARA Title III in particular. We said that we expected to work closely with States to develop mechanisms for sharing 299 information about facilities and oil discharges to improve environmental protection and public health. We indicated that the proposal requires an owner or operator to ensure that any SPCC contingency plan is compatible and coordinated with local emergency plans, including those developed under SARA Title III. We noted that States must adopt and submit to EPA a wellhead protection (WHP) program. We also noted that an owner or operator must comply with both the State WHP program and the SPCC regulations, and that meeting the SPCC requirements did not necessarily ensure compliance with a State WHP program. Comments: Support for coordination. Support for coordination of the SPCC program with SARA Title III. (29, 11) Support for coordination with WHP programs. (27) Response: Support for coordination. We appreciate commenter support. XV­ B­ 3 Flood­ related requirements Background: In §§ 112.8( b)( 6) and 112.9( c)( 3), we recommended – in accordance with EO 11988, "Floodplain Management" – that the SPCC Plan address precautionary measures for facilities in locations subject to flooding. We noted that the National Flood Insurance Program (NFIP) definition of structures included ASTs. We described some of NFIP's requirements and standards, and encouraged owners or operators to consider and comply with the requirements in 44 CFR 60.3 when preparing and implementing an SPCC Plan. We also proposed recommending that an SPCC Plan "address precautionary measures for facilities in locations subject to flooding." In proposed §§ 112.8( b)( 6) and 112.9( c)( 3), we recommended that the SPCC Plan "address additional requirements for events that occur during a period of flooding." Comments: Editorial suggestion. We should move issues related to flooding from the prevention­ related SPCC requirements to the SPCC contingency plan requirements in §112.7( c). (12) Mitigation measures of NFIP. "At a minimum, EPA should address the mitigation measures of the National Flood Insurance Program (NFIP) ... more definitively in the rule rather than addressing them under the preamble." "At a minimum, ..., facility owners or operators should undertake the following: 1) Identify whether the facility is located in a floodplain in the SPCC plan; 2) if the facility is located in the floodplain, the SPCC plan should address to what extent it meets the minimum requirements of the NFIP; and 3) if a facility does not meet the minimum requirements of the NFIP, the SPCC plan should address appropriate precautionary and mitigation measures for potential flood­ related discharges." EPA should also consider requiring facilities in areas subject to 500­ year events to address minimum NFIP standards. (12) NPDES rules. The proposed requirements are duplicative of, and may conflict with, storm water regulations. (35) 300 Recommendation or requirement. We should require – rather than recommend – that NFIP facility owners or operators address precautionary and mitigation measures in the SPCC Plan. (3, 12, 27, 114, 121) Since oil storage facilities could cause significant environmental damage and impact health and safety in a flood, we should require that in areas subject to a 500­ year flood event, a facility owner or operator must address NFIP standards in the SPCC Plan. We should clarify that §§ 112.8( b)( 6) and 112.9( c)( 3) reflect the preamble language. (12) Subject to flooding. We should clarify the term subject to flooding. (9, 27, 115) Response: Recommendation or requirement. §112.8( b)( 6). We deleted this recommendation because it is more appropriately addressed in FEMA rules and guidance, including the definitions the commenters referenced. We disagree that the proposed recommendation should be made a requirement because flood control plans and design capabilities for discharge systems are provided for under the storm water regulations, and further Federal regulations would be duplicative. Other Federal rules also apply, making further SPCC rules unnecessary. Oil storage facilities are considered structures under the National Flood Insurance Program (NFIP), and therefore such structures are subject to the Regulations for Floodplain Management at 44 CFR 60.3. Some of the specific NFIP standards that may apply for aboveground storage tanks include the following: (1) tanks must be designed so that they are elevated to or above the base flood level (100­ year flood) or be designed so that the portion of the tank below the base flood level is watertight with walls substantially impermeable to the passage of water, with structural components having the capability of resisting hydrostatic and hydrodynamic loads, and with the capability to resist effects of buoyancy (44 CFR 60.3( a)( 3)); (2) tanks must be adequately anchored to prevent flotation, collapse or lateral movement of the structure resulting from hydrodynamic and hydrostatic loads and the effects of buoyancy (40 CFR 60.3( c)( 3)); for structures that are intended to be made watertight below the base flood level, a Registered Professional Engineer must develop and/ or review the structural design, specifications, and plans for construction, and certify that they have been prepared in accordance with accepted standards and practice (40 CFR 60.3( c)( 4)); and, tanks must not encroach within the adopted regulatory floodway unless it has been demonstrated that the proposed encroachment would not result in any increase in flood levels within the community during the occurrence of the base flood discharge (40 CFR 60.3( d)). Additionally, the NFIP has specific standards for coastal high hazard areas. See 40 CFR 60.3( e)( 4). §112.9( c)( 1). We have deleted the recommendation because we do not wish to confuse the regulated public over what is mandatory and what is discretionary. These rules contain only mandatory requirements. However, we support the substance of the recommendation, and suggest that a facility in an area prone to 301 flooding either follow the requirements of the NFIP or employ other methods based on good engineering practice to minimize damage to the facility from a flood. Subject to flooding. Because we have not adopted the recommendation that an owner or operator address precautionary measures for facilities located in areas subject to flooding, we have not defined the term subject to flooding, nor have we moved it to §112.7( c). XV­ B­ 4 OSHA Background: In 1991, we said that a number of AST owners or operators are subject to OSHA requirements under 29 CFR 1910.106, and we described some of these OSHA requirements. We noted that these requirements are important for implementing effective spill prevention programs and should be incorporated into SPCC Plans using good engineering practice. Comments: Asks why we said that OSHA requirements are necessary for an effective spill prevention program, when OSHA requirements "stand on their own." Inclusion of OSHA requirements in the SPCC Plan would be unnecessarily duplicative. (34) "We do not recall an OSHA requirement that dike walls must average six feet in height and that earthen dikes must be three feet in height and two feet wide at the top. Where in the regulations are these requirements located. (101,165, L15) Response: We agree that OSHA requirements are independent of SPCC requirements. It is not necessary to duplicate compliance with those requirements in an SPCC Plan. XV­ B­ 5 Industry standards Comments: We should include applicable industry standards in the SPCC regulation. (46) Our proposal is superfluous for smaller capacity ASTs because ASTs and petroleum hazardous substances are "de facto regulated" by fire and safety authorities (e. g., the National Fire Protection Association, the Western Fire Chiefs Association, and the National Building Code Association). (50) Urges referencing of Steel Tank Institute standards in rule. (140) Response: Throughout the rule we generally allow for the application of industry standards where the standards are both specific and objective, and their application may reduce the risk of discharges to and impacts to the environment. We recognize that as technology advances, specific standards change. By referencing industry standards throughout the preamble, we anticipate that the underlying requirements of the rule itself will change as new technology comes into use without the need for further amendments. We believe that industry standards today represent good engineering practice and generally are environmentally protective. However, if an industry standard changes in a way that would increase the risk of a discharge as described in §112.1( b), EPA will apply and enforce the present­ day standard (or, if that is not possible, its equivalent in riskassessment terms) rather than the future, less protective standard. 302 Under the terms of this rule, when there is no specific and objective industry standard that applies to your facility (for example, whether there is no standard or a standard that uses the terms "as appropriate," "often," "periodically," and so forth), you should instead follow any specific and objective manufacturer's instructions for the use and maintenance or installation of the equipment, appurtenance, or container. If there is neither a specific and objective industry standard nor a specific and objective manufacturer's instruction that applies, then it is the duty of the PE under §112.3( d) to establish such specific and objective standards for the facility and, under §112.3( d), he must document these standards in the Plan. If the PE specifies the use of a specific standard for implementation of the Plan, the owner or operator must also reference that standard in the Plan. Throughout today's preamble, we list industry standards that may assist an owner or operator to comply with particular rules. The list of those standards is merely for your information. They may or may not apply to your facility, but we believe that their inclusion is helpful because they generally are applicable to the topic referenced. The decision in every case as to the applicability of any industry standard will be one for the PE. For your convenience, we are including a list of organizations in today's preamble that may be helpful in the identification and explanation of industry standards. 1 See Analysis of the Number of Facilities Regulated by EPA's SPCC Program and Analysis of the Applicability of EPA's SPCC Program to the Electric Utility Industry, June 1996, U. S. EPA. 303 Category XVI: Economic analysis Background: In 1991, we prepared two preliminary economic analyses: "Economic Impact Analysis of the Proposed Revisions to the Oil Pollution Prevention Regulation," and "Supplemental Cost and Benefit Analysis of the Proposed Revisions to the Oil Pollution Prevention Regulation." The first analysis developed cost estimates for the proposed notification along with three other proposed requirements that were determined to result in non­ negligible costs to the regulated community. The second analysis estimated the economic effects of the proposed rule based on alternative expectations about how the regulated community would interpret certain proposed revisions. We presented the results of these studies in the preamble to the proposed rulemaking and invited comment on both the methodology used and the results obtained. XVI ­ A: Estimated universe of regulated facilities Comments: Electrical equipment. The Economic Impact Analysis underestimated the number of electric utility facilities subject to the SPCC regulations. As many as 100,000 electric utility facilities ­­ including 48, 000 electrical substation­ type facilities, 48, 000 industrial or commercial customer locations, and 1,600 other locations ­­ could be subject to the rule. This figure could include 80, 000 electric utility sites. As a result, these figures would result in industry­ wide costs of $2 billion and $1 billion, respectively. (125, 175) Production facilities. We should revise the number of oil production facilities included in the economic analyses to reflect the final division of responsibility between the Department of the Interior (DOI) and EPA as required by Executive Order (EO) 12777. We did not include in the analyses a facility category encompassing drilling rigs and workover units. Since we included such a category of operations in the regulations, we should include these operations in the economic analyses as well. (128) Truck st ops. Our Economic Impact Analysis (EIA) and Supplemental Cost and Benefit Analysis do not identify truck stops as a facility category, and was therefore concerned that the US truck stop industry would not be subject to the SPCC regulations. (43) Response: Electrical equipment. The1995 SPCC Survey indicated that about 2,600 electric utility industry facilities were regulated by the program. We later increased our estimate to 3,700 to account for possible shortcomings in the development of the original estimate. 1 We recognized the possibility that the large number of transformers and other types of oil­ filled electrical equipment that are associated with the estimated 3,700 primary electric utility establishments may not have been fully reflected in the burden estimates for electric utilities included in the 1991 proposed rulemaking analyses. As a result, we have reflected in the Information Collection Request (ICR) and economic analysis for the final rule an increase in the unit burden for a primary electric utility establishment to account for associated oil­ filled electrical equipment (e. g., transformers). 304 As a result of these changes made to the final rule, we expect many utilities to see a decline in compliance costs. Production facilities. We conducted a survey of oil storage and production facilities in 1995 to better estimate the number of regulated facilities. This survey defined oil production facilities as leases, which corresponds to the definition found in the SPCC rule. In the oil industry, a lease is generally regarded as a single oil field operated by a single operator. At the time of the survey, we had already signed a Memorandum of Understanding (MOU) with DOI and the Department of Transportation (DOT) (February 3, 1994) that redelegated the responsibility to regulate certain offshore facilities located in and along the Great Lakes, rivers, coastal wetlands, and the Gulf Coast barrier islands from DOI to EPA. As a result, the 1995 survey provided us with a revised estimate of the total number of oil production facilities regulated under the SPCC program, including drilling rigs and workover units. We used this estimate to calculate the economic effects associated with the final rule. Truck st ops. In the 1995 survey, we classified truck stops as gasoline service stations to the extent that they both share the same primary Standard Industrial Classification (SIC) Code (5541). Regardless of their SIC Code, facilities are subject to the requirements of the SPCC regulation based on the total amount of oil storage capacity and the reasonable possibility of a discharge as described in §112. 1( b). As a result, all truck stops that have an oil storage capacity greater than 1,320 gallons aboveground or 42,000 gallons underground are subject to the SPCC requirements. However, completely buried storage capacity subject to all of the technical requirements of 40 CFR part 280 or a State program approved under 40 CFR part 281 does not count in the calculation of part 112 storage capacity. XVI ­ B: Impacts on small businesses Comments: Costs. We underestimated the cost and level of effort necessary to develop Plans that would meet the requirements we proposed in 1991. (16, 36, 110) The proposed regulation "would significantly impact small operators." (28) The regulation imposes costs, but does not provide any incremental benefit. (28, 31, 34) Our proposed administrative and training requirements would overpower small facilities. (72, 178) The regulations would drastically impact small oil production facilities, although these facilities rarely have the types of spills the SPCC rule is intended to correct. If adopted, the proposed rule would compel extremely costly facility changes, and would be economically detrimental to Appalachian Producers. (101) The proposed rule could contribute to the elimination of many members of the New York oil and gas production community. (165) We failed to recognize the number of small facilities subject to the rule. (L17) Regulatory Flexibility Act. The proposed rule would substantially impact small facilities, and we should therefore perform a Regulatory Flexibility Analysis (RFA). (28, 58, 59, 101, 113, 127, 165, L15) Our Regulatory Flexibility Act certification ignores the proposed rule's impacts on many small shipyards, which qualify as small businesses. (45) The 305 proposed requirements would have a substantial economic impact on the Ohio oil and gas producing industry. We conducted an inadequate economic analysis of the economic impact upon small entities. Our analysis disregards the Regulatory Flexibility Act requirements. (58) We need to perform an RFA if the proposed rules apply to owners or operators of small aboveground storage tanks. (65) Secondary containment. The potential danger from a small spill is insignificant compared to the burden imposed on small operations. (149) This regulation is an unwarranted financial burden for owners or operators of small aboveground tanks facilities with secondary containment. (L17) Small entity. Our method of defining small entity led to an inconsistency with the intent of the Regulatory Flexibility Act. We originally applied the eligibility requirements for Small Business Administration (SBA) assistance to define small entity, and that when we excluded this method in favor of another, our actions were inconsistent with the intent of the Regulatory Flexibility Act. (58) Appalachian Producers could classify as small entities under the Regulatory Flexibility Act. (101) Response: Costs. We disagree with the commenters who stated that the proposed rule would substantially impact small businesses. We conducted a small business screening analysis that we included with the EIA (January 1991). The purpose of conducting this small business analysis was to determine if a formal RFA would be required. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives "which minimize any significant economic impact of the proposed rule on small entities." 5 U. S. C. Sections 603 and 604. Thus, an agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, or otherwise has a positive economic effect on all of the small entities subject to the rule. This rule will significantly reduce regulatory burden on all facilities, particularly small facilities. For example, the rule exempts the smallest facilities from its scope. It also gives all facilities greater flexibility in recordkeeping and other paperwork requirements. Finally, it gives small businesses and all other facilities the flexibility to use alternative methods to comply with the requirements of the rule if the facility explains its rationale for nonconformance and provides equivalent environmental protection. We have therefore concluded that today's final rule will relieve regulatory burden for all small entities. After considering the economic impacts of today's final rule on small entities, we believe that this rulemaking will not have a significant economic impact on a substantial number of small entities. Regulatory Flexibility Act. An RFA is not required if the rule will not cause significant adverse economic impacts on a substantial number of small entities, which is what the small business analysis concluded. To make this determination, we evaluated baseline and post­ compliance financial ratios for typical small firms to evaluate the potential for adverse impacts of bankruptcy. We evaluated four different ratios for firms in 24 different 306 industry categories. Only one of these ratios identified impacts ­­ the ratio that assessed the proportionate impact to small entities compared to larger entities. For six of our 24 industries, the ratio estimated that small entities could be affected in a manner disproportionate to the impact on larger entities. However, the remaining three financial ratio tests showed no significant impact to these industries. As a result, we believe we were correct to state that the rule would not have a significant impact on a substantial number of small entities. We arrived at the same conclusion for the final rule as we have included many other revisions from the 1997 proposed rulemaking that are designed to eliminate many of the smaller facilities from the rule as well as to reduce the overall burden to those facilities that remain regulated under the final rule. The compliance costs used to estimate post­ compliance financial ratios reflected both the one­ time and recurring costs that we estimated in the 1991 Economic Analysis, which we added together to calculate the maximum estimated first­ year burden imposed by compliance. If a firm was not adversely impacted in the first year ­­ when both the onetime and annual recurring costs occurred ­­ we assumed that it would not be subject to a significant adverse economic impact in subsequent years. We also disagree with the comment that we failed to assess the rule's potential impact on small shipyards. We estimated several different financial impacts for numerous facility types manufacturing transportation equipment (SIC 37). Ship building and repairing is a subset of this industrial category (SIC 373) and thus, was captured by our analysis. Secondary containment. Although we characterized the proposed 72­ hour impermeability standard as a baseline, we have not adopted this standard in the final rule. We have retained the current standard which states that dikes, berms, and oil retaining walls must be sufficiently impervious to contain oil, which more accurately reflects current industry standards and practices. We also note that several industry standards exist concerning loading areas (e. g., API 2610) and that the final rule merely clarifies existing SPCC requirements. Small entity. As described in the Economic Analysis for the final rule, we are using SBA definition of small entity. Recently, the categorization of the SBA definitions was revised to correspond to the North American Industry Classification System (NAICS) rather than SIC codes. This change does not affect the SPCC analysis because for the most part, the definitions that applied to facilities based on SIC codes also apply to facilities that are based on NAICS codes, and have the same thresholds for determining if the facility is a small business. XVI ­ C: Use of incorrect data Comments: Disagree with our use of the SBA's FINSTAT database to create a financial analysis of the crude oil and natural gas industries. The database contains business financial information collected between 1976 and 1983 ­­ the zenith of the petroleum crude and natural gas production industry ­­ and that simply adjusting the data for inflation does not accurately capture the industry changes following that period. (58, 128) 307 We should reject the EIA because the document's compliance costs estimates are different than those in the Supplemental Cost and Benefit Analysis. We should have revisited the EIA using the new estimates to determine if the proposed rule would have a significant impact on small entities. (58) Response: We recognized the limitations of SBA's FINSTAT data in our 1991 Small Business Analysis. However, we relied on the data to perform our analysis because at the time, it represented the largest, publicly available database with financial information on small, privately held firms. We also chose to conduct our analysis using a different definition of small business than that used by the SBA in order to better estimate the proposed rule's impacts on the smallest of the small businesses. Had we used the SBA's definition, we would have included in the analysis over 90 percent of the firms in the affected SICs. As a result, the analysis would have been skewed to estimate the effects on the larger of the small businesses, which presumably would have more resources and would be less impacted by the proposed revisions. By concentrating on the smallest of the small businesses, we were better able to determine the effects that the proposed rule would have on small firms. We have always treated these provisions as requirements and thus as part of baseline expenditures by regulated firms. For the most part, small facilities should experience a reduction in compliance burden due to the rise in the regulatory threshold, new formatting options, and flexibility to use alternative methods. XVI ­ D: Miscalculation of costs Comments: Agriculture. The proposed rule would impose a substantial burden on the agriculture industry, and therefore the industry deserves special consideration. The proposed rule overlaps with other regulations. (139) Appalachian and Ohio producers. The proposed regulatory changes would significantly impact small oil and gas producers in the Appalachian Basin by regulating almost all tankage in existence, increasing the number of facilities regulated, increasing the extent and complexity of spill contingency plans, and requiring the implementation of new and expanded construction and operations provisions. (28) The proposed revisions will dramatically impact Ohio oil and natural gas producers. (58, 59, 70) The proposed revisions will pose severe and unique economic hardships to Appalachian Producers. (101, 113) The proposed rule's benefits do not match the costs for producers in the Appalachian Basin, and we should regulate only facilities storing large amounts of oil, and not smaller oil and gas producers. The regulatory changes will cause a large percentage of oil and gas wells in the area to cease operations. (165) Compliance. The small business impact analysis and the EIA cost estimates are sensitive to assumptions of existing compliance. When we relax this assumption in the SBA, compliance costs increase substantially. (182) 308 Costs: PEs, mandatory requirements, reliance on dispersants. Our economic analysis does not truly represent the costs to the regulated community, because we did not properly analyze the following requirements: the specific Professional Engineer (PE) provision found in §112.3( d), the mandatory requirements for medium and large facilities; and the §112.7( d)( 1) contingency Plan prohibition on reliance on dispersants. (L27) Definitions: navigable waters, discharge. We have severely underestimated the economic impact on part 112 facilities because the definitions of navigable waters and discharge have changed drastically since SPCC guidelines were first implemented. (28) Facility notification. The proposed notification form would pose a greater amount of burden for facility owners or operators than we estimated. Outside persons ­­ such as outside contractors or upper management ­­ would be needed to complete the form. The burden would be substantially greater for those facilities without SPCC Plans. (34, 48, 187, 189) Hours burden. Our hours burden estimate of five to 10 hours per year is too low, and estimates industry burden to be about 144 hours per facility ­­ 40 hours per year to comply with the regulation, 40 hours to prepare a training program, 40 hours to prepare training program materials, and 24 hours for employee training. (35) Appalachian facilities would incur a greater hours burden than our estimates because such facilities are remote and widely dispersed. (59) Secondary containment. Our industry cost estimate for the proposed regulations ­­ of $441 million in the first year and $71.8 million each subsequent year ­­ is erroneously low. (28, 31, 36, 58, 113, 165) Comrnenters came to this conclusion by calculating compliance cost estimates for the following requirements: 72­ hour impermeability for secondary containment and diked areas, and installation of containment systems at all truck loading locations. (28, 165) The majority of owners or operators would have to modify or recertify Plans to meet the proposed regulatory changes. (36) The true compliance costs are at least $892 million, as we estimated in the Supplemental Cost and Benefit Analysis. (58) Due to the financial burden, we should not require owners or operators of aboveground tank facilities with secondary containment and total storage capacity of less than 10,000 gallons to develop a Plan. (L17) Small business. The proposed revisions would have a severe economic impact on small businesses throughout the country. (50, 58, 110, 139, 182) The proposed rule imposes on small facilities a disproportionately high level of costs as compared to environmental benefits, because such facilities pose a relatively small risk of spills. (62, 125, 156) Small discharges. The regulation is costly and unnecessary, and we have not established that problems even exist with discharges from small crude oil production facilities. Consequentially, we should gather up­ to­ date, realistic data to make an informed decision. (101) 309 Stripper operations. The proposed revisions would cause many small stripper operations to go out of business. (110) The rule disproportionately impacts small entities specifically stripper operations ­­ relative to medium and large entities, because the Petroleum Extraction Industry's compliance cost to sales comparison impact is nearly twice as high as other industry's, and exceeds the 110 percent ratio. (L27) Training. We should clarify which category of individuals must receive mandatory training, because as the rule is currently written, the economic analysis' cost estimate for training is insufficient. (45) Response: Agriculture. Our Small Business Analysis also considered impacts to small farmers, by analyzing small firms in SIC 1 (agricultural crop production) and SIC 2 (agricultural livestock production). For both SIC Codes, we estimated that the proposed rule would have an insignificant impact on these entities. We arrived at a similar conclusion for the final rule, as we have adopted few new requirements and have provided a de minimis exemption. In addition, we are no longer regulating the smallest facilities. We have also adopted a number of provisions designed to reduce the overall burden for the remaining regulated facilities, which includes eliminating overlap with other Federal requirements (e. g., UST requirements, flexibility in Plan formatting). Appalachian and Ohio producers. We considered the potential impacts on small firms in our Small Business Analysis. In our analysis of SIC 131, crude oil and natural gas production, we determined that small firms in this industry were unlikely to close as a result of the compliance costs associated with the proposed rule. However, these firms may experience disproportionate impacts compared to larger firms. In the final rule, we introduced a de minimis storage capacity, which may benefit a number of the smaller oil production firms. For the firms that remain in the SPCC program, we are finalizing a rule that promotes flexibility and has few new requirements. As a result, we believe that most oil and gas production firms will experience roughly a 40 percent reduction in burden and costs over time. Compliance. In response to the comment that our analysis hinges on our assumption of existing compliance, we note that our assumption of a baseline of full industry compliance is consistent with OMB guidelines for preparing regulatory impact analyses. We produced a Supplemental Analysis to estimate the cost of certain provisions of the proposed rule under the assumption that a number of owner or operators have interpreted the proposed changes as substantive changes in their duties to comply with this regulation. The commenter is correct to point out that as a result of the relaxed assumptions concerning baseline activities, estimated compliance costs increased. In the final rule, we have decided not to adopt many of the proposed revisions that would have added to the baseline compliance costs for facilities (e. g., notification). We also are providing a number of revisions in the final rule designed to decrease the overall compliance burden to regulated facilities as well as to offer facilities increased flexibility to meet their obligations under the rule. Costs: PEs, mandatory requirements, and reliance on dispersants. 310 Dispersants. In 1991, under §112.7( d)( 1), we proposed language clarifying the contents of an appropriate oil spill contingency plan. We omitted the reference to 40 CFR part 109 and instead, specified basic requirements for an oil spill contingency plan. However, in the final rule, we did not adopt the proposed language and instead retained the existing reference to 40 CFR part 109. Mandatory requirements. We disagree that we ignored mandatory requirements in our economic analysis for medium and large facilities. We provided cost estimates in the economic analysis for small, medium, and large facilities. We discussed every proposed revision and noted its effect on the regulated community in the analysis. We did not propose nor did we finalize any requirements that are dependent on facility size. PEs. Final §112.3( d) does not contain a State specific certification requirement for PEs, because the SPCC program is national in scope and therefore State expertise is not necessary. Definitions: navigable waters, discharge. We have made very little substantive change to the definitions of navigable waters and discharge since 1973. The new definition of navigable waters adds clarity and more examples, and is now consistent with other regulatory definitions of the term. The new definition of discharge was made consistent with the Clean Water Act definition as amended in 1978, which exempted certain discharges associated with NPDES permits. This change would not result in an increase in economic impact ­­ rather, some facilities will no longer be regulated as a result of the revised definition because they are no longer expected to discharge oil, leading to a decrease in economic impact. In any case, any change in economic impact due to this definition revision is the result of the change to the statute. Facility notification. We have decided to withdraw the proposed facility notification requirement because we are still considering issues associated with establishing a paper versus electronic notification system, including issues related to providing electronic signatures on the notification. Should the Agency in the future decide to move forward with a facility notification requirement, we will repropose such requirement. Hours burden. We have adopted a model facility approach in estimating the approximate hours burden for facilities to comply with the rule. We adopted this approach to better characterize the diverse universe of regulated facilities. We developed eight different model facilities for this rulemaking – which we designed to represent the typical facility in each category ­­ based on oil storage capacity and primary use of oil. We acknowledge that some facilities may experience a higher hours burden and cost for select activities. However, on average, we believe that the hours burden and cost incurred by our eight different model facilities adequately characterize the approximate burden to other facilities with similar characteristics. Secondary containment. We disagree with the commenters who asserted that we underestimated the cost to comply with the secondary containment and truck loading area 311 requirements. We noted in our 1991 economic analysis that we considered these costs as part of the baseline cost of compliance, which are not affected by the proposed rule. In response to an OMB comment, we later costed out these provisions in a supplemental analysis. In that analysis, we estimated that 78 percent and 88 percent of the regulated community were already in compliance with these requirements, respectively, and would not be affected by the proposed rule change. Since we last performed these analyses, API has issued several industry standards, including API 653 and 2610, which address many of the provisions in the SPCC rule. As a result, the final rule relies on current industry standards and practices, where feasible. In the final rule, we withdrew the proposed 72­ hour impermeability standard for secondary containment and maintained the current requirement that dikes, berms, and oil retaining walls must be sufficiently impervious to contain oil. As a result, the final rule reflects current industry standards and poses no additional requirements on industry. Small business. We disagree that we failed to analyze the impact of the proposed revisions on small businesses. We direct the commenter to the 1991 Small Business Analysis that is appended to the Economic Analysis wherein we analyze the effects of the rule on small business. We also disagree that costs would be disproportionately high for small facilities compared to the benefits. Although our small business analysis did identify that small facilities in some industries could be disproportionately affected, in no instances did it show that these facilities would be significantly impacted. We expect the impact of the final rule will be less than we originally estimated because we have incorporated several changes to reduce the overall compliance burden (for example, the rise in regulatory threshold ­ see §112.1( d)( 2)( ii)). Also, to calculate total aboveground storage capacity, a facility owner or operator need only count containers greater than 55 gallons. The de minimis capacity will eliminate from the rule the smallest of the regulated facilities. We believe that the cost of compliance for smaller facilities will be less than that for larger facilities because smaller facilities are generally less complex than larger facilities. As a result, it will take less effort to prepare and implement a Plan. The supporting analyses for the final rule provides more detailed explanations of our assumptions concerning this issue. Small discharges. A small discharge may have a harmful environmental effect. Therefore, small production facilities need prevention measures to avert costly discharges. Recent analysis confirms this statement. See the Denial of petition requesting amendment of the Facility Response Plan rule, 62 FR 54508 et seq., October 20, 1997. Stripper operations. We disagree that the rule would have an adverse economic impact on stripper wells. We specifically analyzed the impact that the rule would likely have on small businesses involved in crude oil and natural gas extraction (SIC 131). In conducting our closure analysis, we looked specifically at three financial ratios ­­ return on assets, total debt to total assets, and compliance costs to net sales. These tests failed to indicate that small firms in SIC 131 would be significantly impacted. We did find, however, that small firms in SIC 131 may experience disproportionate impacts compared to larger firms in their industry. This was recognized in the Small Business Analysis. 312 Training. In the final rule, we have clarified the language regarding training requirements to apply only to oil­ handling personnel. See §112.7( f). We have not provided a cost estimate for this requirement, because we have always required a facility owner or operator to provide adequate training for facility personnel. The final rule merely clarifies that an owner or operator does not need to train all personnel ­­ only oil­ handling personnel. XVI ­ E: Additional costs Comments: Baseline costs. Changing the regulatory language from should to shall will impose additional costs on part 112 facilities. (45, 113, 125, L27) Electrical utilities industry must perform substantial construction as a result of the changes. These changes are impracticable and unnecessary to address any reasonable risk of discharge at electrical facilities. (125) We incorrectly assume that many facilities are already in full compliance with industry standards, and that we should not consider this scenario as the baseline. (L27) Impermeability requirements. We should not require owners or operators of Appalachian Production facilities to meet the impermeability standards due to the limited environmental benefit and high associated costs. (101) We did not address in the analyses two specific requirements in the proposed revisions ­­ the requirements for containment systems and diked areas to be impervious to oil for 72 hours. These requirements would require significant capital expenditures for many facility owners or operators. (182) Paperwork Reduction Act. The time estimates we listed in the Paperwork Reduction Act certification are erroneous, and too low. (45) PEs. Requiring an independent or outside PE for Plan certification would be extremely expensive for facilities located in remote areas. (59, 65) Requiring the use of an independent or outside PE would be incredibly burdensome to facility owners or operators. (59, 67, 110, 187) Discussions with a PE concerning the use of alternative measures are not negligible costs. Regarding the EIA, we should not have included as a benefit, the requirement for a PE to have no financial interest in the facility because it was not included in the proposed revisions. (L27) Regular inspection of storage tanks. Requiring regular inspection of storage tanks would impose a significant burden on facility owners or operators. (65) Vacuum protection, equalizing lines, reinstallation of dike drains. Asks us to clarify whether we had included the cost of vacuum protection installation into the cost analysis. (31, 101, L15) Asks us to clarify that we had included the cost of equalizing lines installation as specified in §112.9( d)( 4)( ii) into the cost analysis. (101) We should include in the economic analyses the cost of reinstalling tank dike drains as required in §112.9( c), because owners or operators of facilities have removed over 100,000 forewall drains as a result of the part 112 rules of 1973. (L27) 313 Weight restrictions. We failed to recognize the substantial costs to owners or operators of determining accurate weight restrictions. (76) Response: Baseline costs. We note that we only costed out in our analysis the incremental effects associated with the proposed regulatory changes. We did not determine the costs of complying with the existing rule. We have always accounted for these requirements in the information collection burden estimates for the rule, and have always assumed 100 percent compliance by the regulated community. Consequently, because we are merely clarifying in the final rule what is already required of the regulated community and because we have accounted for these costs in our continuing analyses of the program, we have treated these costs as baseline in the analyses supporting this rulemaking. Impermeability requirements. We withdrew the proposed 72­ hour requirement. We are maintaining the extant requirement that dikes, berms, and oil retaining walls must be sufficiently impervious to contain oil. Therefore, there are no incremental costs. The revised rule, like the current rule, does not require a specific impermeability for dikes and does not require a specific method of secondary containment at loading areas, and this flexibility is reflected in our cost estimates. Paperwork Reduction Act. To estimate the burden, we used estimates based on an engineering approach assuming certain small facility characteristics. We note that the actual burden for individual facilities may be greater or less than twelve hours, but consider this estimate to be a fair assumption for the average facility. PEs. These commenters were principally concerned that we did not fully account for the cost to a facility owner or operator for a PE to visit each facility before certifying a Plan. We note that we did not propose this requirement, but requested comments on it. In the final rule, we require either the PE or the PE's agent to visit and examine the facility before the PE certifies the Plan. An agent might include an engineering technician, technologist, graduate engineer, or other qualified person to prepare preliminary reports, studies, and evaluations after visiting the site. The PE, after reviewing the agent's work, could then legitimately certify the Plan. Also, in the final rule, we allow the PE to be an employee of the facility as well as registered in a different State than the facility is located, in order to approve a Plan. The rationale is that SPCC work is national in scope and therefore State expertise is unnecessary. We disagree that the burden for a PE to discuss a deviation in a Plan is an incremental cost. Under the current rule, the PE has the same flexibility in the application of good engineering practice. Therefore, such discussion is a baseline activity. Although we did not propose in 1991 that the certifying PE have no direct financial ties to the facility, we note that we requested comments regarding this issue. In any event, we did not adopt such a provision in the final rule, and note that the benefits of the final rule do not include any consideration of whether the PE has a financial interest in the facility. 314 Regular inspection of storage tanks. Regular inspection of storage containers is already required under the current rule. Therefore, it is a baseline cost and not an incremental effect of the final rule. Reinstallation of dike drains. We disagree that we should include in the economic analyses the cost of reinstalling tank dike drains because neither the current rule nor the final rule requires such reinstallation. Vacuum protection, equalizing lines. Vacuum protection and overflow equalizing lines are measures an owner or operator must consider under the current rule. Our economic analyses only costed out the incremental effects of the proposed rule, not the existing rule's requirements. Therefore, we considered the cost associated with these activities as a baseline cost and we did not include them in our economic analyses. Weight restrictions. We have deleted the proposed recommendation concerning weight restrictions. Therefore, there are no incremental costs to the owner or operator. XVI ­ F: Costs to the electric utility industry Comments: Costs. Our compliance costs for the electric utility industry are erroneously low. Owners or operators of electrical equipment storing 10,000 gallons of oil or less should not be subject to the SPCC requirements because such equipment poses a small amount of environmental risk. (125) We failed to consider the impact of the rule on electrical substations and installations in the current Regulatory Impact Analysis (RIA). As a result, the cost of compliance cited in the RIA is erroneously low. We should prepare a new RIA that accurately reflects the impact of the rule on electric utilities. (130) It would be costly and time­ consuming to comply with the SPCC regulations for facilities with electrical equipment. (41, 184, 189) High viscosity. We should exclude from the proposed secondary containment provisions and integrity testing requirements bulk storage tanks that hold high viscosity petroleum products. We should not require integrity testing and secondary containment for high pour point bulk storage containers, and we did not analyze the costs associated with the proposed requirement. (125) Impact. If electrical equipment is subject to SPCC regulations, then the number of covered utility industry facilities would increase substantially and the rule would have a greater impact on the electric utility industry than we anticipated. (125, 189) Regulatory alternatives. In order to comply with the proposed rules, the electric utility industry faces significantly higher costs than we estimated, yet the industry poses an insignificant environmental risk. The commenter provided cost estimates for the electric utility industry to comply with the following requirements: constructing secondary containment and drainage systems; testing tanks for integrity; complying with the impermeability requirement; and writing and implementing Plans at substations. Because of these costs, the commenter suggested the following alternatives: 315 ° State that electrical equipment is not be subject to SPCC regulations. ° Modify the SPCC risk criteria to ensure that only the facilities which pose a real risk of harm are covered by the program. ° Address specific elements of the proposal that are impracticable or impose undue costs for the avoided risk as applied either to electrical equipment or tanks. (125) Response: Cost, impact, regulatory alternatives. We disagree that it would be costly for facilities with electrical equipment to comply with the SPCC regulation, and that subjecting electrical equipment to the regulations would have a greater impact on the electric utility industry than we anticipated. Such facilities must only comply with requirements for oilfilled electrical equipment, and have considerable flexibility in doing so. Furthermore we have exempted the smallest containers and facilities from the rule. Therefore, costs will be mitigated. In our analysis of the effects of the proposed and final rule, we incorporated a model facility approach. We estimated the costs of complying with the incremental effects of the proposed and final rule changes based on the characteristics assigned to these model facilities. In reality, some facilities may incur greater costs, while other facilities incur lower costs. Since the 1991 rule was proposed, we have redefined our treatment of electric utilities to reflect the slightly greater burden that they may incur to comply with this rule. This change was incorporated in 1997, in response to industry comments concerning our Information Collection Request renewal activities for the SPCC program. We also note that many of the estimates provided by the commenters are not associated with the proposed revisions, and we already require facilities to consider or implement many of these activities. We note, however, that the final rule provides increased flexibility for an owner or operator. In fact, many of the changes reduce the overall burden to electrical utilities. We clarify in the final rule that electrical equipment is subject only to the general SPCC requirements, and not the more specific requirements for bulk oil storage containers. Secondary containment is still required for all facilities under §112.7( c). If it is not practicable for safety or other valid engineering reasons, under §112.7( d), the owner or operator may provide a contingency plan following 40 CFR part 109, and otherwise comply with the requirements of that section. Furthermore, an owner or operator may deviate from most of the rule's substantive requirements if he explains his reasons for nonconformance and provides equivalent environmental protection. 40 CFR 112.7( a)( 2). This provision also cuts costs. We agree that any equivalent prevention plan acceptable to the Regional Administrator qualifies as an SPCC Plan as long as it meets all Federal requirements (including certification by a Professional Engineer), and is cross­ referenced from the requirement in part 112 to the page of the equivalent plan. We do not agree that we should specify acceptable formats. We give examples of those acceptable formats, but those examples are not meant to be exhaustive. See the discussion on §112.7( c) in today's preamble and in this document. 316 One example of an equivalent plan might include a multi­ facility plan for operating equipment. This type of plan is intended for electrical utility transmission systems, electrical cable systems, and similar facilities which might aggregate equipment located in diverse areas into one plan. Examples of operating equipment containing oil include electrical equipment such as substations, transformers, capacitors, buried cable equipment, and oil circuit breakers. A general, multi­ facility plan for operational equipment used in various manufacturing processes containing over the threshold amount of oil might also be acceptable as an SPCC Plan. Examples of operating equipment used in manufacturing that contains oil include small lube oil systems, fat traps, hydraulic power presses, hydraulic pumps, injection molding machines, auto boosters, certain metalworking machinery and associated fluid transfer systems, and oil based heaters. Whenever you add or remove operating equipment in your Plan that will either increase or decrease the potential for a discharge as described in §112.1( b), you must amend your Plan. Multi­ facility plans would include all elements required for individual plans. Site­ specific information would be required for all equipment included in each plan. However, the sitespecific information might be maintained in a separate location, such as a central office, or an electronic data base, as long as such information was immediately accessible to responders and inspectors. If you keep the information in an electronic data base, you must also keep a paper or other backup that is immediately accessible for emergency response purposes, or for EPA inspectors, in case the computer is not functioning. Where you place that site­ specific information would be a question of allowable formatting, as is the question of what is an "equivalent" plan; an issue subject to RA discretion. Finally, we note that many of the smaller substation facilities will be exempted from the SPCC regulations due to the changes to §112.1( d) in the final rule – specifically, the introduction of a 55 gallon de minimis threshold as well as the elimination of the 660 gallon threshold. High viscosity. If the owner or operator wishes to deviate from secondary containment requirements, he may only do so because secondary containment is not practicable in the application of good engineering practice. He must also follow the requirements of §112.7( d) in such case. If he wishes to deviate from integrity testing requirements, he must follow §112.7( a)( 2). However, both of these activities are baseline activities, and therefore, not incremental costs. XVI ­ G: Miscellaneous cost issues Comments: Bioremediation. We are incorrect to assume that Appalachian producers would use off­ site disposal for remediation, because the high costs associated with travel time and distance would dictate another method. (101) We should specifically allow the use of bioremediation and on­ site disposal following a spill event, because of the high costs associated with off­ site disposal. (113) 317 External heating systems. Objects to the cost to facility owners or operators of installing external heating systems. (76) Extraction industry ­ discretionary provisions. The cost of the regulation is greater than indicated in the economic analysis, because the petroleum extraction industry is unable to take advantage of the discretionary provisions for medium or large facilities. The petroleum extraction industry is able to take advantage of the discretionary training provision. (L27) Farmers. Farmers cannot afford to comply with the proposed regulations, and requested that we create an exemption for farmers based on tank size and risk. (106) Insufficient information. We have provided insufficient useful information regarding the economic analyses in the preamble to the proposed rule. Therefore, the public cannot understand or comment on the proposed rule. (110) Jurisdiction, wetlands, sensitive ecological areas. We should reflect in the benefit analysis our change in jurisdiction modified by EO 12777. (128) We should clearly define the jurisdiction of the regulation as well as the terms wetlands and sensitive ecological areas, because the potential costs of the proposed regulation could be devastating for the regulated community. (139) Permanently closed containers. We should consider tanks previously removed from service as permanently closed. Owners or operators would have to bear significant costs to permanently close tanks so the tanks will not apply towards the storage capacity threshold calculation. (101) Recordkeeping requirements. Under §112.9( d) and (e), we should not require owners or operators to retain inspection and test records for five complete calendar years irrespective of ownership, due to the financial burden on the facilities. (113) Scientific rationale. We need scientific justification for the proposed revisions. (127, 132, 139, 160, L27) Secondary containment. Provides cost estimates for many elements of the proposed rule. (31) Produces compliance estimates based on a small, single facility common to oil and gas production in Ohio. (70) The largest single cost to facilities is the proposed §112.7( c) requirement that dikes, berms, and oil retaining walls must be sufficiently impervious to contain oil. The commenter estimated startup costs to be $10,425 and annual costs to be about $260 per facility. (25, 70) State and local regulation. The proposed revisions are unnecessary because State and local agencies already regulate aboveground storage tanks. (127, 139) Triennial review. Questions our cost estimates regarding the triennial Plan review and evaluation. The requirement would cost a well operator $500 for PE certification, and a 318 tank battery operator $3,000 for PE certification. The requirement would cost owners or operators of onshore production facilities $2. 7 million. (103, 113, 187) Response: Bioremediation. We agree with the commenter that bioremediation may be a proper disposal method. We do not assume any particular facility will use bioremediation, but it is an available option. Existing program. We disagree that the revisions to the rule would unnecessarily raise the cost of compliance over the current program because the majority of the changes are clarifications of existing requirements. Also, we did not adopt all of the proposed changes, some of which, like facility notification, would have raised costs. Further, the final rule reduces the regulatory burden by: reducing the total number of facilities subject to the rule; introducing flexibility in formatting and recordkeeping; and, by encouraging the use of industry standards to comply with SPCC requirements. External heating systems. We deleted the proposed recommendation to consider the feasibility of installing an external heating system from §112.8( c)( 7). That proposed recommendation is currently a requirement. Therefore, we have reduced costs for an owner or operator. Extraction industry ­ discretionary provisions. The rule does not prescribe differing requirements for facilities merely based on size. We have not established discretionary provisions for any facilities. All of the rule provisions are mandatory. However, an extraction facility may avail itself of a deviation in the same manner as any other facility. Farmers. We disagree that farmers cannot afford to comply with the rule. However, in the final rule, we have raised the regulatory threshold. We no longer regulate a facility that stores 660 gallons or more of oil in a single aboveground tank, so long as the aggregate aboveground storage capacity does not exceed 1,320 gallons. We expect that a significant number of small facilities ­­ including farms ­­ will benefit from this change, and expect the majority of small facilities with a single oil tank to no longer be regulated. We refer the commenter to the supporting analyses for more specific estimates on the estimated impacts. We also exempt containers of less than 55 gallons from all rule requirements. Insufficient information. We disagree that we failed to provide sufficient information regarding the economic analysis in the preamble. We summarized the results of the economic analyses therein. The economic analyses are available for review in the public docket for those wishing to review more specific information on the approach we used to estimate our results. We believe that many of the commenters who were concerned about the costs and benefits of the proposal will find that the changes made in the final rule are to their benefit. Jurisdiction, wetlands, sensitive ecological areas. The applicability of the rule is clearly set out in §112.1. We have added a definition for wetlands in the final rule to provide 319 clarity for the regulated community. We discussed sensitive environments in the final 1994 Facility Response Rule. See 59 FR 34070, 34089, July 1, 1994. In our analysis of the impact of the final rule, we consider the jurisdictional effects of EO 12777 (56 FR 54757, October 22, 1991). Section( b)( 1) of EO 12777 delegates to the EPA authority in section 311( j)( 1)( C) relating to the establishment of procedures, methods, and equipment, and other requirements for equipment to prevent and to contain discharges of oil and hazardous substances from non­ transportation­ related onshore facilities. Section( b)( 2) of EO 12777 delegates similar authority to contain discharges of oil and hazardous substances from vessels and transportation­ related onshore facilities and deep water ports to the Secretary of Transportation. Section( b)( 3) of the EO delegates similar authority for offshore facilities, including associated pipelines, other than deep water ports, to the Secretary of the Interior. An MOU between EPA, DOT, and DOI, found at Appendix B to part 112, redelegated from DOI to EPA the responsibility for non­ transportation­ related offshore facilities located landward of the coast line. Similarly, the MOU redelegated from DOI to DOT the responsibility for transportation­ related offshore facilities, including pipelines, landward of the coast line. Thus, only a small fraction of SPCC­ regulated facilities are affected by the EO and MOU, and the majority of those facilities were already taken into account in the benefits analysis. Permanently closed containers. We believe that containers that have been permanently closed according to the standards prescribed in the rule qualify for the designation of "permanently closed," whether they have been closed before or after the effective date of the rule. Containers that cannot meet the standards prescribed in the rule will not qualify as permanently closed. To clarify when a container has been closed, we have amended the rule to require that the sign noting closure show the date of such closure. The date of such closure must be noted whether it occurred before or after the effective date of this provision. Some States and localities require a permit for tank closure. A document noting a State closure inspection may serve as evidence of container closure if it is dated. Recordkeeping requirements. We agree that a requirement to retain records for five years is too long, and have withdrawn the proposed requirement in favor of the general requirement in §112.7( e) to maintain records for three years. Secondary containment. We appreciate the comments providing associated cost of compliance data. We note that we have improved the methodology used to estimate the effects of the rule by expanding the types of model facilities used in the analysis. The costs we have estimated for each model facility type are approximations that are meant to reflect average costs to a facility having similar characteristics as our model facility. In reality some facilities will experience higher or lower costs than what we have estimated. Overall, however, we believe that this technique gives us a reasonable estimate of the program's entire costs and cost savings. Scientific rationale. We believe that each of the revisions to the SPCC rule being adopted have an adequate scientific, policy, and legal basis. In response to comment, we have not promulgated a number of proposed provisions. 320 State and local regulation. We disagree that the rule is unnecessary because State and local agencies already regulate aboveground storage tanks. Both the States and EPA have authority to regulate containers storing or using oil. We believe State authority to regulate in this area and establish spill prevention programs is supported by section 311( o) of the CWA. Some States have exercised their authority to regulate while others have not. We believe that State SPCC programs are a valuable supplement to our SPCC program. We do not preempt State rules, and defer to State law that is more stringent than part 112. We also note that you may now use a State plan as a substitute for an SPCC Plan when the State plan meets all Federal requirements and is cross­ referenced. When you use a State plan that does not meet all Federal requirements, it must be supplemented by sections that do meet all Federal requirements. At times EPA will have rules that are more stringent than States rules, and some States may have rules that are more stringent than those of EPA. If you follow more stringent State rules in your Plan, you must explain that is what you are doing. Triennial review. We have extended the time in which an owner or operator must review the Plan from at least once every three years to at least once every five years. As a result, we expect that facility owners or operators will experience an overall reduction in the annualized cost of conducting such a review. The costs associated with this activity are baseline costs that we have already determined in numerous information collection burdens. The impacts of this change are discussed in the supporting analyses to the rule. Further, we have clarified in the final rule that a PE must certify only technical Plan amendments. XVI ­ H: Miscalculation of benefits Comments: Costs, benefits. The benefit values calculated in the analyses are too great, and the economic benefit of applying the proposed changes to oil and gas production facilities is far outweighed by the cost. The benefits of the proposed changes would be at most in the tens of thousands of dollars per year. (28, 165) We failed to accurately predict the costs, and we overestimated the benefits of the proposed regulation in spite of the economic analyses. (35) We quantified the benefits in incredibly broad terms, and we counted spill reductions as benefits, even though we already counted these as benefits of prior regulations. (128) Discharges avoided. Disagrees with our estimate found in the Supplemental Cost and Benefit Analysis for the benefits associated with avoiding cleaning up an oil spill. The cost to clean up such a spill is considerably less, and therefore our benefit estimation is too high. (101) Although we cite as a potential benefit the increased revenue from sales of petroleum products not lost in spills, a facility owner or operator already strives to avoid spill events wherever possible due to the stated incentive. (L27) 321 Facility notification. We have not described how we monetized the benefits of the proposed notification form and regulatory revisions. However, we cannot possibly monetize these benefits without first identifying any problems with the current SPCC program. (31, 34) We should not count as a benefit compliance with the proposed notification provision, and noted that this action is actually a burden. (128) Human health and the environment. The benefits resulting from the proposed regulations will have little if any benefit in protecting human health or the environment and do not justify the standards we are requiring for facilities subject to the part 112 requirements. (28, 74, 110, 113, 137, 149, 160, 192) Response: Costs, benefits. We disagree that we failed to accurately predict the costs, and that we overestimated the benefits of the rule in spite of the economic analyses. We believe that we have adequately explained in our economic analysis the methods used to predict costs and benefits. The final rule will reduce costs by millions of dollars a year for regulated facilities. Discharges avoided. Our method of calculating benefits for the 1991 proposal involved an attempt to quantify the value of avoided oil spilled and associated clean­ up costs that would result from the proposal. While some commenters believe that we may have overestimated the unit cost of clean­ up for some types of facilities, we believe that our overall estimate was fairly reliable because we most likely underestimated clean­ up unit costs for other types of facilities. As we noted in the analysis, "the cost to clean up oil spills may vary substantially, depending on a number of parameters including: the environmental medium that is contaminated; the sensitivity of the environment to spills (spills to wetlands); the size of the spill; the type of oil; and the length of time it takes for a response action to begin, among others." Since we initially performed this analysis, there has been substantial development in this area as a result of the Oil Pollution Act of 1990 (OPA). Facility notification. We have withdrawn the facility notification proposal. Therefore, there are no costs associated with it in the final rule. Human health and the environment. We disagree that the rule will have little if any benefit in protecting human health or the environment and does not justify the standards we are requiring for facilities subject to the part 112 requirements. We believe that the final rule will reduce the overall compliance costs to industry without sacrificing any protection to the environment. As previously noted, the measurable benefits attributable to the final rule are related to the estimated reduction in associated burden for SPCCregulated facilities. We believe this burden reduction will be approximately 40 percent for the regulated universe. This reduction is principally associated with our decision to incorporate many industry standards and practices into the rule, along with the decision to extend the length of time in which a facility owner or operator must review and evaluate the Plan. We also have adopted a number of revisions designed to increase the flexibility a facility needs to comply with the requirements of the rule. We have not adopted the notification provision and the 72­ hour impermeability standard for secondary containment, 322 which many commenters opposed based on associated costs. Further, we have decided to no longer regulate small facilities storing less than 1, 320 gallons in a single aboveground container. We note that while we did not describe how we monetized the estimated benefits of the proposed rulemaking in the preamble, we did provide a cite to the Supplemental Cost and Benefit Analysis of the Proposed Revisions, which was available to the public throughout the rulemaking process. 323 Category XVII: General comments XVII­ 1 Support or opposition to the proposed rule Comments: Support for proposed rule. The proposed revisions clarify and strengthen the SPCC program and protect the navigable waters of the United States. (4, 27, 54, 64, 67, 81, 82, 105, 107, 115, 135, 136, 142, 147, 153, 158, 161, 164, 181, 184) The proposed amendments would "enhance the safety of the SPCC program." (54) The revisions would make the regulation clearer and facilitate compliance. (136) The revisions would make the SPCC program enforceable. (184) The proposed changes would help prevent major problems with aboveground storage tanks and piping systems. (L1) There would be "no dual regulation in offshore areas." (L12) Opposition to proposed rule. Burdensome or costly. Implementing the proposed rule would be burdensome. (83, 91, 102) The proposed requirements would force the regulated community to ignore the rule, or go out of business. (122) The proposed requirements would impose expensive and unnecessary administrative burdens, monitoring and reporting requirements, and other excessive compliance costs on a facility. (35, 86, 111, 113, 131, 184, 189, 192, L35) We must consider drafting regulations that protect the environment, and are affordable to this country's businesses. (139) Current rule adequate. Current SPCC regulations are adequate to assure the protection mandated by the CWA and the Oil Pollution Act (OPA). (35, 71, 101, 192, L30) Existing regulations are adequate, and further regulatory measures are not necessary. (110, 149) Decreased flexibility. Adopting the proposed requirements would limit or curtail the flexibility in the current regulation. (35, 91, L30) Adopting our proposals would not benefit the environment. (35, 86, 148, L35) The proposed rule is "highly inflexible." (184) Interpretation. The proposed revisions have been "subject to incorrect and unnecessary interpretation." (100, 103) OPA. We should not promulgate the proposed revisions. (101) The proposed rulemaking did not implement the Oil Pollution Act of 1990 (OPA). (31, 34, 35) Production facilities. Oil and gas exploration and production and gas processing industries have been "highly effective in implementing the SPCC program and in controlling releases of oils to the waters of the United States." Our "substantial" proposed revisions were unjustified given the record of losses in the production sector, and the relatively small size and isolated location of most production facilities. (86) 324 Reduced environmental protection. In some cases, the proposed rule could "decrease the protection afforded under the current rule." Many operators prepare SPCC Plans for all storage facilities ­­ regardless of how close the facility is to navigable waters. Overly burdensome SPCC Plan requirements such as we proposed, could discourage owners or operators from continuing that practice. (86) Substantial risk. Supports the proposed rule only insofar as it addresses the standards applicable to facilities that pose a substantial risk to navigable waters of the U. S. because they store or handle large bulk quantities of oil. (156) Technically ill­ conceived. The proposed regulation is technically ill­ conceived. (110) Unnecessary. The proposed regulations are unnecessary. (35, 71, 113) The proposed requirements would result in a considerable burden and expense for facilities, with no commensurate environmental benefit. (88, 153, 167) The proposed changes would not improve the overall effectiveness of oil pollution program regulations. (103) Vague. Certain proposed provisions are unclear and technically impractical. (67, 83, 91, 100, 102, 103, 131) Response: Support for proposed rule. We appreciate commenter support. Opposition to proposed rule. We disagree with the general opposition to the proposed changes. We proposed the changes largely to make part 112 clearer and simpler, to reflect expanded jurisdiction under the CWA, and to respond to recommendations of the SPCC Task Force and General Accounting Office report. We have considered comments on the technical viability of the proposed requirements and made many changes in the rule based on those comments. Further, the final rule contains a number of provisions designed to decrease regulatory burdens on an owner or operator. It gives him greater flexibility than the current rule by allowing him to choose methods that best protect the environment. We maintain the good engineering practice standard which encourages an owner or operator to use industry consensus or other appropriate standards, rather than prescribing particular procedures, or monitoring or inspection schedules. For most of the substantive requirements, when a facility owner or operator can demonstrate that a particular provision is infeasible based on facility­ specific circumstances, an owner or operator may substitute alternative measures that provide environmental protection equivalent to part 112 requirements. In 1991, we prepared two preliminary economic analyses to support the proposed rule, including an initial economic impact analysis under Executive Order (EO) 12291 and a supplemental cost and benefit analysis. For the final rule, we have assessed the economic effects as required by EO 12866 and relevant statutes. We think that we have 325 considered costs and burdens adequately, and invite the interested reader to review the Regulatory Analyses at the end of the preamble to the rule we adopted and the docket for this rulemaking. XVII­ 2 Editorial changes and clarifications Comments: ANPRM. Asks us to use an Advance Notice of Proposed Rulemaking (ANPRM) for discussing issues on which we simply asked for comments. (121) Plain language, "countermeasure." We should use the active voice and simple English. Part 112 is unnecessarily wordy. (121) We should drop the "s" from countermeasures in the proposed rule. (7, 9, 121) We should make the same change in 40 CFR part 264. (7) Recommendations. Asks us to simplify the regulation by omitting recommendations or discretionary provisions. Suggests that we develop a separate "Code of Good Practice" for recommendations. We would have difficulty enforcing provisions where we did not use an imperative statement. (44, 121) Syntax and grammar. Several commenters made suggestions regarding syntax and grammar. (27, 54, 76, 79, 100, 121, L26) . Response: ANPRM. We believe that it would have been redundant to use an Advance Notice of Proposed Rulemaking (ANPRM) for discussing issues on which we simply asked for comments in 1991. The 1991 preamble was an appropriate mechanism for the comment request. Plain language, "countermeasure." We have made changes to correct grammar and typographical errors, to promote consistency, and used a plain­ English format to make part 112 clearer and easier to use. A plain English format includes maximum use of the active voice; short, clear sentences; and, in this rule, a summary of the major regulatory changes. Using this format is part of our continuing regulatory reinvention efforts. We have revised the term "countermeasures" to read "countermeasure" in the term Spill Prevention, Control, and Countermeasure Plan. We cannot revise "countermeasures" in 40 CFR part 264 as part of this rulemaking because we did not propose any changes to that part. Recommendations. We have not included discretionary provisions in the final rule because we do not wish to confuse the regulated community by being unclear about what is mandatory and what is discretionary. We will provide guidance or policy statements, as necessary, that will include some or all of these recommendations. In the absence of such guidance or policy statements, we urge an owner or operator to look to current industry standards for guidance on technical issues. Syntax and grammar. We have corrected errors in syntax and grammar. 326 XVII­ 3 Public participation and call for more data Comments: Basis for rule. We did not discuss what major release or spill scenarios compelled us to propose changes, nor why the proposed changes would improve the situation. We should show more data and empirical evidence that demonstrate why the regulation is necessary. We should re­ propose this rule based on new data, which display and target the design and operating problems that require improvement. (148) Our data is deficient because we did not use Petroleum Extraction Industry statistical data or State data. (L27) Liner Study. Section 4113 of OPA required the President "to conduct a liner study, report the study results to Congress, and implement the study recommendations six months after the report. We have not completed the study and have not made it available to commenters. We should withdraw proposed regulations on secondary containment until we complete the study, and the affected industry had an opportunity to comment on the study during rulemaking. (32) We should release this study for public comment before submitting it to Congress so that we have the full benefit of industry's practical experiences with liners and other means of containment. (54) SPCC Task Force. We left out many small businesses in America by consulting only with American Petroleum Institute (API), and not with the Oklahoma Independent Petroleum Association (OIPA) or the Independent Petroleum Association of America (IPAA). (11) We should have included Professional Engineers on the SPCC Task Force (Task Force). (11,110) Criticizes the Task Force because it was composed entirely of Federal and State regulatory officials and notes that there were no representatives from affected industries or State oil and gas commissions. The Task Force could not have evaluated regulatory issues impartially, or have received sufficient input regarding potential regulatory impacts on industry. The Task Force report was of extremely limited value as a basis for rulemaking. (32) Response: Basis for rule. We disagree that we did not state our purpose in the proposed rule, and refer the reader to our extensive discussion of the proposals in the NPRM. Similarly, we cannot agree that our data and analyses are deficient, and refer the reader to the rulemaking docket for our supporting data and analyses. We note that we receive additional data from industry representatives and other interested persons which we considered throughout our rulemaking process. Liner Study. We completed the liner study and published a report to Congress in May 1996. The study is available to interested readers on our website at epa. gov/ oilspill. SPCC Task Force. Federal regulatory agencies must observe various procedural requirements to assure that there is adequate opportunity for the public to participate in rulemakings. While the membership of the task force may not have included certain groups, everyone had the opportunity to comment on the proposal. We considered all comments and made many changes based on them. 327 XVII­ 4 Adequacy of existing Plans Background: In 1991, we requested comments on whether existing SPCC Plans were adequate to meet the requirements of the regulation we proposed. We requested comments to help us estimate the extent to which the proposed requirements may impose new compliance costs. Comments: Existing SPCC Plans would not meet the provisions we proposed. (16, 36, 79, L8, 129) Owners or operators would have to modify existing Plans if we adopt the new provisions included in the proposed regulation. (16, 79, L8) Response: Many Plans will only need to include cross­ referencing modifications. An owner or operator will find it necessary to modify his existing Plan to meet the requirements of the final rule, if only to cross­ reference existing requirements to redesignated requirements. To reduce the burden, we permit the use of a Plan supplement which cross­ references the location of requirements listed in the revised rule with the equivalent requirements in an existing Plan. In the final rule preamble, we provide a table to assist owners or operators with this cross­ referencing. XVII­ 5 Other comments Comments: Comments. We should consider all comments on the proposed regulations, including those from the regulated community. (135) Comprehensive program. The proposed regulation will be ineffective in preventing spills, unless we substantially increase staff for facility inspections and enforcement. Using part 112 in 1991 would have lessened the justification for a new up­ to­ date and comprehensive national aboveground tank law. We should work with Congress to develop a comprehensive spill prevention program, rather than follow a piecemeal approach to oil spill prevention. (111) Drafting. When we draft regulations, we should acknowledge company efforts. (139) In promulgating the final rule, we should eliminate "broadly written statements that would expand the coverage of this proposal without increasing the environmental benefit." (L6) Generic Plans. We were incorrect in assuming that a widespread practice for owners or operators of large companies is to develop generic SPCC Plans without considering specific plant requirements. (39) Reducing pollution. We should provide incentives for reducing the potential for oil pollution of navigable waters. (L12) Substantive changes. The proposed regulations represent "substantial requirements and not mere clarifications." Cites substantive requirements and "should to shall" changes as examples. By failing to give fair notice of the nature of our proposed revisions to the Oil 328 Pollution Prevention regulations, we did not provide for adequate public participation in the rulemaking process, as we are required to do under 553( b) of the APA. (32) Response: Comments. We have carefully considered all comments, and made many changes based on them. The final rule protects the environment while reducing the information collection burden on the regulated community. Comprehensive program. We appreciate the commenter's concern regarding our program funding. We agree that a comprehensive approach to oil pollution prevention is best. To further that approach, the SPCC program and the UST program have worked together to eliminate duplicative regulation in this rule. Except for facility diagram requirements, we have eliminated from the SPCC program all completely buried tanks subject to all of the technical regulations of 40 CFR part 280 or of a State program approved under 40 CFR part 281. Drafting. We agree that we should eliminate "broadly written statements that would expand the coverage of this proposal without increasing the environmental benefit," and believe we have done so. We also acknowledge company efforts to protect the environment and to comply with the rule. Generic Plans. We do not assume and never have assumed that it is a widespread practice for owners or operators of large companies to develop generic SPCC Plans without considering specific plant requirements. We do acknowledge that most companies attempt to comply with the rule. In response to the comment that we should provide incentives for reducing the potential for oil pollution of navigable waters, we agree and have done so. We have retained the flexibility in the rule that permits an owner or operator to use alternate methods to achieve pollution prevention goals. Reducing pollution. We agree that we should provide incentives for reducing the potential for oil pollution of navigable waters and believe we have done so in this rule. Incentives include flexible formatting and recordkeeping, use of industry standards, and the availability of deviations for most substantive provisions. Substantive changes. We disagree that "the should to shall to must" change is substantive. See the discussion in section IV. C. in the preamble to today's final rule. The changes to the text of existing substantive requirements are mostly clarifications. There are few new requirements in the final rule. Moreover, we discussed the "should" to "shall" issue in the preamble of the proposed rule. XVII­ 6 Request to extend the comment period and hold public hearings Background: In 1991, we said that we would consider comments submitted on or before December 23, 1991, which was 60 days after we published the proposed rule. We also said that if the comments we received indicated sufficient need, we would consider holding a public hearing 329 Comments: Extension of comment period. Many commenters asked for 30 to 60 more days to comment. (13, 17, 18, 19, 20, 31, 42, 58, 108, 110, 120, 122, 142, 160, 184, L22). Requests more time, asserting that the rule was lengthy and complicated. (13, 20) Requests more time to review the economic, fire safety, and environmental consequences of our proposed changes. (17) End­ of­ the­ fiscal­ year requirements prevented reviewing the proposed rule in the 60­ day time frame. (18, 19, 20) Although we allowed commenters 60 days to respond to our proposed changes, commenters had only 45 days by the time a copy of the Federal Register arrived in the mail. The commenters also noted that they had to wait to receive copies of the economic analyses that we made available through the mail upon request. (31, 110) Requests an extension to review the equipment upgrade and soil removal requirements. (160) Asks for an extension for time to visit and learn more about facilities affected by the proposed changes. (184) A State rule revision process is insufficiently advanced to allow commenters to provide comments within our time frame. (L22) Public hearings. We should hold public hearings to discuss the proposed changes. (11, 31, 35, 42, 79, 110, 129, 142, L28) Public hearings would benefit small businesses without staff to monitor the Federal Register. (11) Asks that we hold public hearings in locations throughout the United States for small businesses without the money to travel to Washington, D. C. (11, 31, L28) Holding public hearings would give the regulated community a chance to present an accurate assessment of the costs associated with the proposed changes. (31) Asks us to grant an extension and hold public hearings to give petroleum exploration and production facility owners or operators an opportunity to inform us about the broad impacts of the proposed rule on these facilities. (142) Response: Extension of comment period. While we did not extend the comment period for the 1991 rulemaking, we believe that a 60­ day comment period was adequate, and consistent with other Federal agencies. We note that we considered comments received as late as April 1993. Public hearings. We decided that there was insufficient need for a public hearing because the written comments provided exhaustive arguments on each side of nearly every relevant issue. XVII­ 7 Support for comments submitted by other commenters Background: We received many comments from writers who simply endorsed a letter or position of another writer. Comments: Support for the Utility Solid Waste Activities Group comments on part 112. (92, 100, 130, 138, 163,164) Support for Utility Water Act Group comments. (100, 120, 130, 138, 163) Support for Ohio Electric Utilities Institute comments. (163) Support for comments from the Edison Electric Institute, the American Public Power Association, and the National Rural Electric Cooperative Association. (138) 330 Support for comments from the American Petroleum Institute. (64, 83, 85, 91, 94, 96, 97, 102, 133, 173, 174) Support for the Rocky Mountain Oil and Gas Association comments. (174) Support for comments from the Independent Petroleum Association of America. (160, 167) Support for comments from the Mitchell Energy and Development Corporation and the American Exploration Company. (160) Support for comments from the Institute of Shortening and Edible Oils, Inc. (30), and the Ohio Oil and Gas Association (59). Response: For responses to specific comments, refer to the appropriate sections of this document.

epa

2024-06-07T20:31:41.223871

regulations

EPA-HQ-OPA-1997-0002-0071

Supporting & Related Material

SPCC­ 7­ 3­ 8 OPA­ 1997­ 0002­ 0071 RESPONSE TO COMMENTS RECEIVED IN 1993 FOR SPILL PREVENTION ISSUES IN THE SPILL PREVENTION CONTROL AND COUNTERMEASURE (SPCC) RULEMAKING U. S. Environmental Protection Agency Office of Emergency and Remedial Response Table of Contents Response to Comments Received in 1993 for Spill Prevention Issues in the Spill Prevention, Control, and Countermeasure (SPCC) Rulemaking Section Page Introduction 3 1. Authority to Require Preparation of Plans ­ §112.1( f) 5 2. Plan Amendment by the RA ­ §112.4( a) 8 3. Submission of a Plan that contains a deviation ­ §112.7( a)( 2) 9 4. Contingency Planning ­ §112.7( d)( 1) 11 5. Employee Training ­ §112.7( f) 12 6. Brittle fracture evaluation ­ §112.7( i) 18 7. Facility Security 22 8. Corrosion Protection 22 9. Lightning Strike Protection 23 10. Leak Detection 23 11. Certification of Tank Installation Plans 24 12. General Comments 24 3 INTRODUCTION Purpose of this Document The purpose of this document is to respond to comments received on the 1993 Spill Prevention, Control, and Countermeasure (SPCC) proposed rule (58 FR 8824, February 17, 1993, 40 CFR part 112). These proposed revisions are in addition to revisions to part 112 proposed in 1991 and 1997. Background of this Rulemaking Part 112 of 40 CFR outlines requirements for both prevention of and response to oil spills. The prevention aspect of the rule requires preparation and implementation of an SPCC Plan. The SPCC requirements were originally promulgated on December 11, 1973 (38 FR 34164) under the authority of section 311( j)( 1)( C) of the Clean Water Act (CWA). The regulation established spill prevention procedures, methods, and equipment requirements for non­ transportation­ related onshore and offshore facilities with aboveground storage capacity greater than 1,320 gallons (or greater than 660 gallons in a single container), or completely buried oil storage capacity greater than 42,000 gallons. Regulated facilities are also limited to those that, because of their location could reasonably be expected to discharge oil in quantities that may be harmful, into the navigable waters of the United States or adjoining shorelines, or that affect certain natural resources. On October 22, 1991, (56 FR 54612) we proposed changes in the applicability of the SPCC regulation and the required procedures for the completion of SPCC Plans, as well as the addition of a facility notification provision. The proposed rule also reflected changes in the jurisdiction of CWA section 311 made by amendments to the CWA in 1977 and 1978. Those proposed revisions, as modified, are included in this final rule. On February 17, 1993 (58 FR 8824), we again proposed clarifications of and technical changes to the SPCC rule, as well as facility response plan (FRP) requirements to implement the Oil Pollution Act of 1990 (OPA). The proposed SPCC changes included clarifications of certain requirements, authorization for the EPA Regional Administer (RA) to require Plan preparation at otherwise exempt facilities, prevention training, and requirements for brittle fracture evaluation. All FRP comments were summarized in a June 1994 Comment Response Document. The FRP requirements of the 1993 proposal were promulgated on July 1, 1994 (59 FR 47384) and codified at 40 CFR 112.20­ 21. The SPCC requirements, as modified, are finalized today. 4 Organization of this Comment Response Document We first identified the issues in the June 1994 Comment Response Document that were related to the SPCC provisions, rather than to the FRP provisions. Comments on proposed revisions related to the SPCC issues were not given complete responses at the time because we deferred action on those proposals. We carefully reviewed the issues and the letters received in the public docket, and developed the categories shown in the Table of Contents. For each category in this document, we provide summaries of the issue and the points raised by the commenters. These summaries are supplemented, where necessary, by quotations from the letters to reflect the nuances of certain comments that could not be adequately captured through summarization. After summarizing the issue and comments, we provide a response to each of the comments or group of similar comments on each issue. The document is arranged into sections according to the issues listed in the Table of Contents. We identify each comment by a comment number. The comment numbers were assigned in the public docket when the letter was received. For this document, the comments we selected from each letter include only those addressing SPCC issues. 5 1. Authority to Require Preparation of Plans ­ §112.1( f) Background: Section 112.1( d) exempts certain facilities from the requirement to prepare and implement an SPCC Plan. In 1993, we proposed to add §112.1( g) (redesignated as §112.1( f) in the final rule) to allow the Regional Administrator (RA) to require an otherwise exempted facility, that is subject to EPA jurisdiction under section 311( j) of the CWA, on a case­ by­ case basis, to prepare and implement an SPCC Plan. Comments: Appeals process. Requests an appeals process for owners and operators (1141 and 1220), and others (1139, 1171, 1173) requested time frames within which the RA must act. Suggests that the proposed implementation times (six months for Plan preparation and one year for Plan implementation) may be too short to be practicable. (1208) Authority, standards. Questions our authority to require Plan preparation by otherwise exempted facilities, and requests standards for requiring Plans. (1137, 1167, 1208, 1220, L1, and L19) Suggests that If EPA requires Plan preparation by otherwise exempt facilities, we should clarify that: (1) it only intends to cover underground storage tanks currently included in the SPCC program, (2) this expansion is not intended to be used against facilities with aboveground storage less than 1,320 gallons total facility storage or 660 gallons in a single tank, (3) it will only require underground storage tank facilities to comply with basic SPCC requirements, and (4) it will maintain the preliminary determination scheme discussed on page 8844, second full paragraph. Also notes that SPCC deficiency notices are sometimes inadequate. (L1) Response Plans. Concerned that §112.1( g) would allow the Regional Administrator to require a small facility to prepare a response plan in addition to an SPCC Plan. (1172) Technical expertise. Opposes the provision because of the authority given to the RA: "Paragraph 112.1( g) allows the Regional Administrator to require the operator to prepare an SPCC plan even if a Professional Engineer determines such a plan is not technically required. The Regional Administrator is a political appointee without technical training. Further, the Regional Administrator will not have visited the facility. Typically, the Agency personnel making a visit is not a Professional Engineer. Accordingly, the proposed Paragraph (g) allows a non­ professional person or engineer to override a technical decision on the basis of people not eligible to certify an SPCC plan." (955) Underground Storage Tank (UST) program. Suggests that in order to address environmental concerns not adequately addressed under the UST regulation, we should revise the UST program rather than the SPCC program. (1155) 6 Response: Appeals process. We agree that an appeals process is appropriate for this section. Therefore we have included a new paragraph (f)( 5) to include such a process, and have provided time frames for the process. The appeals process is modeled upon proposed §112.4( f), which we reproposed in 1991 and have finalized today. Authority. EPA has adequate authority under section 311 of the CWA to require any facility within its jurisdiction to prepare a Plan that could because of its location, cause a discharge as described in §112.1( b). This authority is broad enough to encompass the storage or use capacity of any exempted facility within EPA's jurisdiction, regardless of size. Standard to use authority. RAs may invoke this section to carry out the purposes of the Act on a case­ specific basis when it is needed to prevent a discharge as described in §112.1( b), and thus protect the environment. While we expect to use this section sparingly, it is necessary to address gaps in other regulatory regimes that might best be remedied by requiring a facility to have an SPCC Plan. Factors the RAs may consider in making a determination that a facility needs an SPCC Plan include, but are not limited to, the physical characteristics of the facility, the presence of secondary containment, the discharge history of the facility, and the proximity of the facility to sensitive environmental areas such as wetlands, parks, or wildlife refuges. An example of the use of this section might be when a facility is exempted from SPCC rules because its storage capacity is below the regulatory threshold, but the facility has been the cause of repeated discharges as described in §112.1( b). The RA might require an entire Plan, or might only require a partial Plan addressing secondary containment, for example, to prevent future discharges as described in §112.1( b). Partial Plans. We clarify that the RA may require partial Plans to cover situations where the preparation of only a partial Plan may be necessary, such as to supplement an existing document other than a Plan or to address a particular environmental threat. The decision to require a Plan (or partial Plan) could be based on the presence of environmental concerns not adequately addressed under UST or National Pollutant Discharge Elimination System (NPDES) regulations, or due to other relevant environmental factors. The section may be invoked when the RA determines it is necessary to "carry out the purposes of the Act." The decision to require a partial Plan is separate from a decision to require an amendment to a Plan. In one case, the assumption is that a Plan doesn't exist; in the other, that an existing Plan needs amendment. Response Plans. Section 112.1( f) applies only to the total or partial preparation of an SPCC Plan. It does not authorize the Regional Administrator to require you to prepare a facility response plan. We have withdrawn a proposal (see 1993 proposed 7 §112.7( d)( 1)) which would have required you to prepare a response plan when your SPCC facility lacked secondary containment. Therefore, most facilities will incur no response planning costs. Instead, if your facility lacks secondary containment, you must prepare a contingency plan following the provisions of 40 CFR part 109, and otherwise comply with §112.7( d). As a result, requirements to prepare a facility response plan are contained solely in §112.20, and not §112.1( f). Technical expertise. PEs may work for the RA, but even if such is not the case, the RA has the expertise to determine when a facility should have an SPCC Plan. The decision to require an SPCC Plan from an otherwise­ exempt facility will be made on technical, not political grounds. The authority we give to the RA under §112.1( f) will be used to carry out the purposes of the CWA and protect the environment. Factors the RA may consider in making a determination that a facility needs an SPCC Plan include, but are not limited to, the physical characteristics of the facility, and the proximity of the facility to sensitive environmental areas such as wetlands, parks, wildlife refuges, etc. For example, the RA may use this authority to require plan preparation by the owner or operator of a facility that has had repeated discharges as described in §112.1( b). UST program. The comment suggesting revision of the UST program is beyond the scope of this document. 8 2. Plan Amendment by the Regional Administrator ­ §112.4( a) Background: Section 112.3( e) requires a facility owner or operator to make the Plan available to the RA for onsite review during normal working hours. The revision to §112.4 proposed in 1993 would give the RA authority to require the facility to submit information at any time, and to provide the RA authority to require that the owner or operator amend the Plan after on­ site review. Comments: Appeals process. Calls for an appeals process for owners and operators. (1172, 1198, 1220) Information submission authority. Questions the broad authority given to the RA. Stresses the cost to facilities and suggests the need for the RA to show good cause. (955, 1137, 1172 1208, 1220, 1224) Inconsistencies. "By authorizing the various RA to pick­ and­ choose specific measures deemed necessary at a specific site, inconsistencies will arise leading to overly stringent and/ or improperly implemented spill provisions in addition to establishing site­ specific competitive disadvantages. Moreover, the choice of changes in the design and implementation of spill prevention measures should be left to the facility owner. Industry has the broad expertise to determine costeffective spill prevention controls and processes." (1137) Multiple Plans. Concerned that the RA might require an owner or operator to submit Plans for all of his facilities. (1167) Technical evaluation skills. The RA is not a Professional Engineer (PE) and does not have the technical skills to decide the need for the Plan. (955) Response: Appeals process. We agree that an appeals process is appropriate, and have provided for it in §112.4( f). Information submission authority. We agree that the proposal to give the RA the authority to require §112.4( a) information at any time was vague, and have therefore withdrawn that provision. We will only require such information after the discharges specified in this section. We will consider cost factors in our site­ specific amendment decisions. Multiple Plans. We have withdrawn the proposal to provide the RA with authority to require submission of the information required in §112.4( a), including the Plan, at any time because we believe the proposal was vague. 9 Technical evaluation skills. PEs and others with technical expertise work for the RA, and help him make amendment decisions. 3. Submission of a Plan that contains a deviation ­ §112.7( a)( 2) Background: In §112.7( a)( 2), we proposed to allow deviations from the requirements of §§ 112.7( c), 112.8, 112.9, 112.10, and 112.11, as long as the facility owner or operator described his reasons for nonconformance and discussed alternative methods, provided equivalent protection, and submitted the SPCC Plan to the RA. Comments: Support for proposal. "This requirement appears to be in order." (1170, 1208) Opposition to proposal. Burdensome. "If upon inspecting a facility, EPA believes that a waiver is unjustified, it can examine the merits of the waiver in the context of that facility's compliance with the SPCC rules. We believe that it is unduly burdensome to require regulated facilities to prepare a justification and submit a plan to EPA for every waiver of the technical requirements." (1198) Unnecessary. Opposes submission of the entire Plan because it is unnecessary. The Plan has already been certified by a PE. (955, 1063, 1145, 1218, 1239, L1) Appeals process, RA oversight. "Alternative methods should not trigger the need to provide administratively burdensome notification. The choice of preventative systems in the design and implementation of spill prevention measures should be left to the facility owner, who has the broad expertise to determine cost­ effective spill prevention controls and processes. We oppose the proposed provision which provides the RA authority to require equivalent protection. If, however, the Agency chooses to promulgate this provision, [the commenter] recommends that the Agency include an appeal process." (1137) Response: Support for proposal. We appreciate commenter support. However, we agree with the opposing commenters that submission of a deviation to the Regional Administrator is not necessary and have deleted the proposed requirement. We take this step because we believe that the requirement for good engineering practice and current inspection and reporting procedures (for example, §112.4( a)), followed by the possibility of required amendments, are adequate to review Plans and to detect the flaws in them. Upon submission of required information, or upon on­ site review of a Plan, if the RA decides that any portion of a Plan is inadequate, he may require an 10 amendment. See §112.4( d). If you disagree with his determination regarding an amendment, you may appeal. See §112.4( e). Appeals process, RA oversight. We agree that there should be an appeals process and have provided it within §§ 112.1( f) and 112.4( f). RAs are to follow the principles of good engineering practice and not overrule a deviation unless it is clear that such deviation fails to afford equivalent environmental protection. This does not mean that the deviation must achieve "mathematical equivalency," as one commenter pointed out. But it does mean equivalent protection of the environment. We encourage innovative techniques, but such techniques must also protect the environment. Technical deviations, like other substantive technical portions of the Plan requiring the application of engineering judgment, are subject to PE certification. We also believe that in general PEs will seek to protect themselves from liability by only certifying measures that do provide equivalent environmental protection. But the RA must still retain the authority to require amendments for deviations, as he can with other parts of the Plan certified by a PE. 11 4. Contingency Planning ­ §112.7( d)( 1) Background: When the installation of structures or equipment in §112.7( c) is not practicable, under current §112.7( d)( 1), the facility owner or operator must provide a "strong oil spill contingency plan following the provisions of 40 CFR part 109." In 1993, we proposed to replace the reference to a strong oil spill contingency plan with a reference to the facility response plan, as described in §112.20. Comments: Opposition to proposal. Opposes the proposed change because it is unnecessary, burdensome, and beyond Congressional intent in OPA. (1063, 1198, 1208) Response: We agree with the commenters that the present contingency plan arrangements are sufficient to protect the environment and that a facility response plan as described in §112.20 is therefore unnecessary for most SPCC facilities. We agree that structures or equipment might achieve the same or equivalent protection as response planning for some SPCC facilities. Therefore, we are withdrawing that part of the 1993 proposal (i. e., proposed §112.7( d)( 1)) requiring submission of a facility response plan and are retaining the current contingency planning provisions, which require a contingency plan following the provisions of 40 CFR part 109. We also believe that response plans should be reserved for higher risk facilities, as provided in §112.20. 12 5. Employee Training ­ §112.7( f) Background: In 1993, we proposed to limit the applicability of the training requirements to only those facilities that transfer large amounts of oil. We further proposed that employees involved in "oil­ handling activities" be required to receive 8 hours of facility specific training within one year and 4 hours of refresher training In subsequent years. Training for new employees would be required within one week of employment. We also proposed to specify the areas in which employees should be trained to include: training in correct equipment operation and maintenance, general facility operations, discharge prevention laws and regulations, and the contents of the facility's SPCC Plan. Finally, the proposed rule would require annual unannounced drills. Comments: Applicability of training requirements ­ employees. Support for proposal. Supports mandatory training of personnel at facilities that transfer oil. (1171, 1173) Opposition to proposal. Burden and cost. Several commenters pointed out that they must follow training requirements of other programs. (1095, 1137, 1148 1150, 1169, 1198, and L1) "Complying with regulatory requirements of the various training programs in the environmental arena have become very difficult at large manufacturing facilities. The administrative burden and cost to develop and implement the training programs, and productivity losses associated with the time the employee is being trained are substantial. A typical [commenter] facility may have up to 50 employees that are involved with oil­ handling (i. e., the transfer of oil from one location to another). At a typical hourly rate of $25, the cost can exceed $10,000 per facility, excluding the substantial cost associated with productivity losses. The overwhelming administrative burden and cost associated with employee training reinforces the importance that it be required for only those situations where environmental benefits and risk are the greatest." (1137) Employer discretion. Employees should be trained according to their specific job responsibilities (the approach taken by the USCG) rather than the facility's size or type and that the owner or operator should determine the best training practices for the facility. (1135, 1137, 1140, 1146, 1148, 1153, 1155, 1169, 1170, 1196, 1198, 1219) Depending on the task, some employees may not obtain the appropriate level of training in 8 13 hours, while others may receive more information than necessary. (1093, 1135, 1198, 1231, 1232) Applicability of training requirements ­ facilities. Support for proposal. Supports the proposed training requirements and adds that such requirements would be beneficial to all SPCC­ regulated facilities, not just those that meet the specified oil transfer quantity thresholds. (1140, 1153) Opposition to proposal. Threshold too low. The oil transfer threshold should be raised. (1165, 1172, 1208, 1217,1218) "To specify the amount of training and to require unannounced drills is unnecessarily and prohibitively expensive. [We] recommend that EPA continue the guidelines in the existing 40 CFR Part 112 (40 CFR §112.5( e)( 10)), but in the event training requirements must be adopted, then remain with the standards set forth in the rule proposal of October 21, 1991. In the event the training requirements being proposed in the February 17, 1993, notice are necessary, then increase the threshold limit so as to avoid inadvertently imposing the requirement for training on a small [facility]." (1172) The volume triggers proposed in §112.7 are not in keeping with Oil Pollution Act (OPA) criteria. (1208) Threshold too high. The threshold should be lowered. (1171, 1173, 1245) Supports requirements for mandatory training, but feels that lowering the threshold would increase the number of facilities that would be subject to the regulation and, therefore, reduce the potential for spills. (1171, 1173) Because the hose connection/ disconnection step of the oil transfer process results in most spills, frequent small transfers are potentially more dangerous than one large transfer operation. (1245) Complex operations. Unclear about what is meant by "complex operations." (1153) Content of training. Training should include instruction in the implementation of the facility response plan. (1153) Effect of 1993 proposal. Questions whether the training requirements specified in §112.7( f) in the Notice of Proposed Rulemaking (NPRM) replace those proposed in the October 22, 1991, revisions to the SPCC rule. No training is specified for employees of facilities not meeting the oil transfer quantities and frequencies cited in the NPRM. (1142) Suggested exemptions. 14 Extraction industries. Pipeline transportation of oil is quite safe; therefore, oil extraction industries should be exempted from the increased training requirements. (955, 1220) Nonmarine terminals. Requests exemption for small nonmarine terminals. (1215) Small facilities. Because of the relatively small turnover of employees at small facilities, these facilities should be exempt, and such exemptions could be granted on a case­ by­ case basis according to site­ specific factors. (1153, 1167, L1) "The eight­ hour training requirement contemplated in the proposal is too much for the vast majority of independent petroleum marketers. The smaller scale of marketer facilities does not necessitate such extensive training....[ the commenter] suggests EPA's training proposal apply only to substantial harm facilities and that EPA accept existing forms of training currently required as a substitute or supplement. If EPA insists on requiring training for all facilities that meet the transfer threshold, [we] would reiterate the above request to accept other forms of training as a substitute or supplement, and suggest that small "mom and pop" facilities, whose employees tend to be constant, are not required to undertake annual training refreshers." (L1) Timing of employee training. Opposition to proposal. Alternate time frames. Opposes the proposed requirement for training within the first week of employment for new employees. Requiring additional training beyond that which is required by other agencies within the first week of employment is difficult, if not impossible. Suggests the following time frames: 30 days (1150, 1215), 45­ 60 days (1169), 90 days (1063, 1095), or 180 days (1137, 1196, 1198). Before involvement in oil­ handling operations. EPA should specify only that training be provided before the employee becomes involved in oil­ handling operations. (1135, 1146, 1155, 1232) Cost. Creating training materials and holding the proposed training would take too much time and cost too much. (1137, 1207, 1217, 1219) Current requirements adequate. The current training requirements and those proposed in the October 22, 1991, revisions to the SPCC training requirements are sufficient. (1172, 1208, 1217) 15 Employer discretion. "[ The commenter] recommends that EPA not mandate a specific frequency of training. EPA should allow owners the flexibility to initiate training at intervals frequent enough to assure adequate understanding of the SPCC plan by their employees." (1137) The duration of the training should be left up to the discretion of the owner or operator of the facility. (1093, 1231) Employee turnover. Four hours per year for refresher training is unnecessary for facilities without employee turnover or without changes in operations. (1135, 1198) Length of training. Eight hours of training would not be suitable for all employees at all facilities; some would require more than 8 hours, others less. (1093, 1135, 1140, 1146, 1153, 1169, 1198, 1208, 1231) The amount of training should be based on the size, capacity, and location of the facility rather than on the type of operations (i. e., transfers) that occur at the facility. (1148, 1170) Facilities with engineered safety systems should be subject to reduced training requirements. (1198) Eight hours of training is excessive when added to the current training that is already required at SPCC­ regulated facilities, especially for most smaller independent petroleum marketers. (955, 1198, 1208, L1) Response capability. We should eliminate the proposed training requirements and instead require facilities to demonstrate the ability of the employees to respond to an oil discharge. (1170, 1198, 1199) Transfers. We should limit the term "transfer" to exclude transfers from storage containers to units that combust or utilize the oil, because the movement of oil to boilers may not pose as great a risk of release compared with other transfer operations. (1198) We should clarify the meaning of "transfer ... oilin a singleoperation" in proposed §112.7( f)( 1). (1155, 1248) Unannounced drills. Criticizes the proposal to require annual unannounced drills. (1093, 1146, 1155, 1169, 1172, 1199, 1218, 1231) The requirement should be limited to personnel involved in spill response. (1093, 1199, 1218, 1231) The facility operator should decide when drills are needed. (1146, 1155) Response: Support for proposal. We appreciate commenter support. Applicability of training requirements. We believe that training requirements should apply to all facilities, large or small, including all those that store or use oil, regardless of the amount of oil transferred in any particular time. Training may help avert human error, which is a principal cause of oil discharges. "Spills from ASTs may occur as a 16 result of operator error, for example, during loading operations (e. g., vessel or tank truck ­ AST operation), or as a result of structural failure (e. g., brittle fracture) because of inadequate maintenance of the AST." EPA Liner Study, at 14. We have therefore retained the applicability of training to all facilities. The 1993 proposal would have limited training requirements to only certain facilities which received or transferred over the proposed amount of oil. Facilities which receive or transfer less than the proposed amount might also have discharges which could have been averted through required training. Also the proposed rule would have exempted many facilities that use rather than store oil from its scope. Therefore, we have provided in the rule that all facilities, whether bulk storage facilities or facilities that merely use oil, must train oil­ handling employees because all facilities have the potential for a discharge as described in §112.1( b), and training is necessary to avert such a discharge. We agree with the commenter that training is only necessary for personnel who will use it to carry out the requirements of this rule. Therefore revised paragraph (f)( 1) provides that only oil­ handling personnel are subject to training requirements, as we proposed in 1993. "Oil­ handling personnel" is to be interpreted according to industry standards, but includes employees engaged in the operation and maintenance of oil storage containers or the operation of equipment related to storage containers and emergency response personnel. We do not interpret the term to include secretaries, clerks, and other personnel who are never involved in operation or maintenance activities related to oil storage or equipment, oil transfer operations, emergency response, countermeasure functions, or similar activities. You may incorporate SPCC training requirements into already existing training programs required by other Federal or State law at your option or may conduct SPCC training separately. You must document that you have conducted required training courses. Such documentation must be maintained with the Plan for three years. Complex operations. In the 1993 preamble, we noted that the complexity of operations includes such factors as the number of tanks and transfer points, throughput, and the presence of sophisticated pumping or switching equipment at regulated facilities. Content of training. Content of training. Specifying a minimum list of training subjects is necessary to ensure that facility employees are aware of discharge prevention procedures and regulations. As suggested by a commenter, we have added knowledge of discharge procedure protocols to the list of training subjects because such training will help avert discharges. Therefore, we have specified that training must include, at a minimum: the operation and maintenance of equipment to prevent the discharge of oil; discharge procedure protocols; applicable pollution control laws, rules, and regulations; general facility operations; and, the contents of the facility Plan. 17 As noted above, we require response training for facilities that must submit response plans, but such training is not necessary for all SPCC facilities. In response to the utility commenter who asserted that utility employees do not need to be trained in the maintenance of oil storage tanks because such maintenance does not involve the transfer and handling of oil, we note that training must address relevant maintenance activities at the facility. If there is no transfer and handling of oil, such topic need not be covered in training. Effect of 1993 proposal. The 1993 proposal superseded the 1991 proposal. Timing of employee training. We agree with commenters who thought it desirable to leave the timing and number of hours of training of oil­ handling employees, including new employees, to the employer's discretion. "Proper instruction" of oil­ handling employees, as required in the rule, means in accordance with industry standards or at a frequency sufficient to prevent a discharge as described in §112.1( b). This standard will allow facilities more flexibility to develop training programs better suited to the particular facility. While the rule requires annual discharge prevention briefings, we also agree that the annual briefings required are not drills. In any case, the SPCC rules do not require drills, as explained below. For purposes of the rule, it is not necessary to define a "new employee" because all oilhandling personnel are subject to training requirements, whether new or not. You do, however, have discretion as to the timing of that training, so long as the timing meets the requirements of good engineering practice. Unannounced drills. We agree that the proposed requirement is unnecessary because drills are already required at FRP facilities, which are higher risk facilities. Therefore, there are no new costs. We do not believe that the risk at all SPCC facilities approaches the same level as at FRP facilities. 18 6. Brittle fracture evaluation ­ §112.7( i) Background: In 1993, we proposed to require a facility owner or operator to evaluate a field­ constructed tank for risk of failure due to brittle fracture, if the tank undergoes repair, alteration, or a change in service. Evaluation would be accomplished by adherence to industry standards contained in American Petroleum Institute (API) Standard 653, entitled "Tank Inspection, Repair, Alteration, and Reconstruction." In the preamble to the proposed rule, we mentioned that as an alternative to incorporation of Section 3 of API Standard 653, we considered requiring all tanks to undergo a full hydrostatic test to determine their potential for brittle fracture. Comments: Support for proposal. Agrees that brittle fracture evaluation should be conducted in accordance with industry standards contained in API Standard 653. These commenters did not support hydrostatic testing as an alternative. Shopfabricated tanks do not require an evaluation for brittleness. (1149,1150, 1169, 1172, 1198, 1208, L1) Opposition to proposal. Secondary containment. Opposes the proposal on the basis that the evaluation was unnecessary for small volume tanks and tanks with secondary containment. (1173) Small facilities. Small facilities should be exempted from the proposed requirement. (1167) Additional measures. Recommends additional (i. e., in addition to evaluation for brittle fracture) protective measures for incorporation into the proposal, specifically undertank liners, and hydrostatic testing of tanks. (1200) Alternatives to brittle fracture. API standards. Industry standards specify when and where owners or operators should use specific tests. API Standard 653 allows the owner or operator the flexibility to implement a number of options for identifying and preventing problems which ultimately lead to a tank integrity failure. (67) We should adopt the inspection provisions of API Standard 653 since it is specifically for aboveground tanks storing petroleum and suggests intervals for internal and external inspections. (71) API Standard 653 is a more appropriate starting point than API Standard 650 for determining material toughness. Standard 653 concerns tank inspection, repair, alteration, and reconstruction and addresses brittle fracture concerns. (102) 19 Change in service. Asks for clarification of the term "change in service." (1141, 1167, 1198, 1225) Disagrees that a tank evaluation is necessary with every change of service. (L8) Field erected tank. Asks for clarification of the term "field­ erected tank." (955) Other catastrophes. We should incorporate API Standard 653 into our rules to accommodate the possibility of tank failures other than through brittle fracture. (1149) Alteration, Repair. Asks for clarification of the terms "alteration" or "repair," so that they excludes ordinary day­ to­ day maintenance activities, which are conducted to maintain the functional integrity of the tank and do not weaken the tank. The definitions should not include the term "or related equipment" to conform with API Standard 653. (1093, 1198, 1231) Steel­ bolted tanks. Such testing is unnecessary for steel­ bolted tanks because they are too thin to be subject to brittle fracture since material properties are uniform through the thickness. (955, 1218, 1220, 1199) Response: Support for proposal. We appreciate commenter support. Additional measures. We will consider under­ tank liners as a possibility for a future rulemaking. Hydrostatic testing of tanks is a possible method now for integrity testing in combination with visual inspection. Applicability. The requirement to evaluate field­ constructed tanks for brittle fracture whenever a field­ constructed aboveground container undergoes repair, alteration, reconstruction, or change in service is necessary because brittle fracture may cause sudden and catastrophic tank failure, resulting in potentially serious damage to the environment and loss of oil. The requirement must be applicable to large and small facilities alike, because all the field­ constructed aboveground containers have a risk of failure. The presence or absence of secondary containment does not eliminate the need for brittle fracture evaluation because the intent of the rule is to prevent a discharge whether or not it will be contained. The requirement for evaluation of a field­ constructed aboveground container must be undertaken when the container undergoes a repair, alteration, reconstruction, or change in service that might affect the risk of a discharge or failure due to brittle fracture, or when a discharge or failure has already occurred due to brittle fracture or other catastrophe. Catastrophic failures are failures which may result from events such as lightning strikes, dangerous seismic activity, etc. As a result of a catastrophic failure, the entire contents of a container may be discharged to the environment in the same way as if brittle fracture had occurred. 20 Steel­ bolted tanks. While the requirement applies to all field­ constructed aboveground containers, if you can show that the evaluation is unnecessary for your steel­ bolted tanks, you may deviate from the requirement under §112.7( a)( 2) if you can explain your reasons for nonconformance and provide equivalent environmental protection. We note that portions of steel­ bolted tanks, such as the bottom or roof, may be welded, and therefore subject to brittle fracture. Alteration. We agree with the commenter will not include the term "or related equipment" in the definition of "alteration" to conform with API Standard 653, which does not include alterations of related equipment as a criterion for brittle fracture evaluation. "Alteration" means any work on a container involving cutting, burning, welding, or heating operations that changes the physical dimensions or configurations of the container. Typical examples include the addition of manways and nozzles greater than 12­ inch nominal pipe size and an increase or decrease in tank shell height. Alternatives to brittle fracture evaluation. We have eliminated the incorporation by reference to API Standard 653 from the rule. We have also therefore withdrawn proposed Appendix H, the API Standard 653 brittle fracture flowchart. We believe that API Standard 653 is an acceptable standard to test for brittle fracture. However, an incorporation by reference of any standard might cause the rule to be instantly obsolete should that standard change or should a newer, better method emerge. A potential standard might also apply only to a certain subset of facilities or equipment. Therefore, as with most other requirements in this part, if you explain your reasons for nonconformance, alternative methods which afford equivalent environmental protection may be acceptable under §112.7( a)( 2). If acoustic emission testing provides equivalent environmental protection it may be acceptable as an alternative. That decision, in the first instance, is one for the Professional Engineer and owner or operator. Change in service. A "change in service" is a change from previous operating conditions involving different properties of the stored product such as specific gravity or corrosivity and/ or different service conditions of temperature and/ or pressure. Field erected tank. A field­ erected tank or container is one that is assembled outside of a factory at the location of its intended use. A field­ constructed container cannot be shipped partially or fully­ constructed, and must be fabricated at the job site. It is to be contrasted with a shop­ constructed tank which is assembled in a factory and shipped to the job site completely assembled, but may need minor modifications in the field. Other catastrophes. In response to the comment, we added "or other catastrophe" after the words "brittle fracture" to indicate that failures of other kinds might require evaluation. 21 Repair. We agree with the commenter and will not include the term "or related equipment" in the definition of "repair" to conform with API Standard 653, which does not include repairs of related equipment as a criterion for a brittle fracture evaluation. "Repair" means any work necessary to maintain or restore a container to a condition suitable for safe operation. Typical examples include the removal and replacement of material (such as roof, shell, or bottom material, including weld metal) to maintain container integrity; the re­ leveling or jacking of a container shell, bottom, or roof; the addition of reinforcing plates to existing shell penetrations; and the repair of flaws, such as tears or gouges, by grinding or gouging followed by welding. We understand that some repairs (such as repair of tank seals), alterations, or changes in service will not cause a risk of failure due to brittle fracture; therefore, we have amended the rule to refer to those repairs, alterations, or changes in service that affect the risk of a discharge or failure due to brittle fracture. 22 7. Facility Security Background: In 1993, we requested information on the need for security measures (in addition to those in §112.7( e)( 9)) to mitigate the potential for discharges. In the final rule, we have renumbered §112.7( e)( 9) as §112.7( g). Comments: Security provisions in the rule are adequate and additional security measures are unnecessary. (1169,1198) Any additional security measures should be based on site­ specific factors and left up to the discretion of the owner or operator and certifying engineer. (1169, 1171, 1173) Response: We agree, and have not added additional security measures, but we have increased the flexibility of the provision to allow greater consideration of site­ specific factors. Additional comments on security are addressed in the Response to Comments document for the 1991 proposal. 8. Corrosion Protection Background: In 1993, we requested comment and cost information on the effectiveness of cathodic protection and other corrosion protection methods for preventing leaks. Comments: Support for a requirement. Supports a requirement for corrosion protection if portions of the aboveground tank are in contact with soil. (1150, 1200) Opposition to a requirement. "... existing practices/ standards are adequate to identify potential areas of concern with tank bottoms and that cathodic protection should be one option available to the facility in developing a cost­ effective tank management approach." (1169) New regulations are unnecessary. (1198) Cost. "[ The commenter] is employing cathodic protection as a means of controlling corrosion of the external (soil side) bottom of new aboveground storage tanks and the soil side of new replacement bottoms of exiting tanks. Cathodic protection is used to supplement select sand bottom padding used to support the tank bottom. The select sand and cathodic protection are installed within the envelope of a secondary containment liner. Unit cost for providing and installing the cathodic protection portion of this system varies inversely with tank size, ranging from approximately $1.00 to $2.00 per square foot of tank bottom area. A significant drawback to this design is the prohibitive cost to repair or replace the cathodic protection system once installed. Cathodic protection can be retrofitted to existing tanks in the absence of impervious secondary containment liners at lesser unit cost due to flexibility of system design and combination of multiple tanks into one position scheme. However, these systems are rendered ineffective if impervious secondary containment liners are installed." (1148) 23 Response: We appreciate the comments. We are not adding additional provisions to require corrosion protection for aboveground containers at this time. We will consider these comments for a future rulemaking. 9. Lightning Strike Protection Background: Lightning strikes and fires resulting from the strikes can contribute to the discharge of oil. In 1993, we requested comment on the costs and benefits of installing protection systems on Aboveground Storage Tanks (ASTs). Comments: Mandatory lightning strike protection is unnecessary. (1148, 1169, 1198, 1224) The low incidence of damage to tanks from lightning would mean that such requirements would not be cost effective. (1148, 1224) Response: We appreciate the comments and will consider them in a future rulemaking. 10. Leak Detection Background: We noted in the 1993 preamble that early detection of small oil leaks could alert owners or operators to needed repairs or mitigation measures, prevent damage to the environment, and save on costs of cleanup. We requested comment and cost effectiveness information on leak detection methods for ASTs, such as ultrasonic testing and inventory reconciliation, and comment on the appropriateness of testing underground piping for leaks. Comments: Support for requirement. With regard to leak testing of underground piping associated with tanks, the requirements of API 570 should be followed. (1148) "By the argument presented in this comment, it is suggested that the most practical and cost effective method to prevent bottom leaks in large tanks is a combination of leak detection equipment in new tanks and tank inspection for all tanks." (1149) Inventory reconciliation and periodic conductivity testing should be required for ASTs, as well as periodic hydrostatic testing of all underground piping. (1171, 1173) A study on leak detection methods for ASTs should be conducted and that hydrostatic testing of underground piping for leaks should be required. (1200) Opposition to requirement. "[ The commenter] recommends that the EPA permit alternatives to internal tank inspections in the final rule in order to allow facilities the flexibility to address site­ specific conditions." (1169) Additional leak detection requirements are unnecessary, particularly for viscous fuel oils. (1198) Inventory reconciliation is not an accurate or reliable method of leak detection. (1198, 1149, 1148, 1206) 24 Response: We appreciate the comments and will consider them in a future rulemaking. 11. Certification of Tank Installation Plans Background: In 1993, we requested comment on methods that would ensure the proper installation of ASTs (e. g., certification of tank installation plans and/ or monitoring of installation by a PE or other qualified individual). A PE is required to review and certify the SPCC Plan, but the SPCC requirements do not address specific facility procedures such as tank installation. The UST regulations (40 CFR 280.20( e)) require certification of compliance with proper installation practices and certification of the qualifications of tank installers. Comments: American Petroleum Institute (API) standards. Tanks are constructed in accordance with API standards and these standards are sufficient. Support for requiring qualified individuals to ensure proper tank design and installation plans. (1148, 1149, 1200) UST program. Certification for ASTs should follow the UST program. (1169) Unnecessary. Additional certification programs are unnecessary. (L6, L8) Response: We appreciate the comments and will consider them in a future rulemaking. 12. General Comments Comments: Other technical considerations. The "other technical considerations," which were not proposed but listed in the 1993 Preamble, should not be requirements because they would have little environmental benefit and substantial costs. (1058, 1137, 1172) The impacts from many of the problems considered in the "other technical considerations" can be mitigated by proper secondary containment. (1208) Response: Other technical considerations. We appreciate these comments and will consider them in a future rulemaking.

epa

2024-06-07T20:31:41.355163

regulations

EPA-HQ-OPA-1997-0002-0072

Supporting & Related Material

SPCC­ 7­ 7­ 18 OPA­ 1997­ 0002­ 0072 ECONOMIC ANALYSIS FOR THE FINAL REVISIONS TO THE OIL POLLUTION PREVENTION REGULATION (40 CFR PART 112) Office of Emergency and Remedial Response U. S. Environmental Protection Agency May 2002 1 58 FR 51735. 2 U. S. Environmental Protection Agency, Reinventing Environmental Regulation, March 16, 1995. 2 CHAPTER 1 INTRODUCTION 1. 1 BACKGROUND AND PURPOSE OF THIS RULEMAKING Executive Order 12866 aims to reform the regulatory system to "protect and improve" the "health, safety, environment, and well­ being" of Americans "without imposing unacceptable or unreasonable costs to society." 1 Section 5 of the Executive Order requires Federal agencies to periodically review their existing significant regulations to determine whether any such regulations have become unjustified or unnecessary as a result of changed circumstances – i. e., that they: (1) have become incompatible with other existing regulations, (2) have become unnecessarily burdensome, or (3) are not consistent with the President's priorities and therefore should be modified or eliminated. In response to Executive Order 12866 and the government's subsequent National Performance Review, the U. S. Environmental Protection Agency (EPA or the Agency) set a goal of reducing by 25 percent the paperwork burden associated with the Agency's regulatory requirements that were in effect as of January 1, 1995. 2 To attain its 25 percent paperwork burden reduction goal, EPA has examined both the need for its paperwork requirements and methods by which essential information can be collected and provided at the lowest cost to the regulated community. EPA has worked extensively with industry, States, and other interested groups to identify ways to minimize reporting and recordkeeping requirements. On June 1, 1995, EPA reported to the President all of the monitoring, recordkeeping, and reporting regulations that it believed were duplicative and unnecessary. The changes to the Oil Pollution Prevention regulation (40 CFR part 112) presented below are being finalized to further reduce burden on regulated entities and to help the Agency reach its burden reduction goal without compromising protection to public health or welfare or to the environment. The purpose of this Economic Analysis (EA) is to provide estimates of the potential costs and benefits of the final revisions being made to 40 CFR part 112. This regulation establishes requirements for Spill Prevention Control and Countermeasure (SPCC) Plans to prevent spills of oil into or upon the navigable waters of the United States or adjoining shorelines or affecting certain natural resources by nontransportation related onshore and offshore facilities. The Agency is finalizing changes that would reduce the information collection burden of the rule and that would reduce 3 56 FR 54612. 4 58 FR 8824. 5 62 FR 63812. 3 inefficiencies and overlap with other regulations, thus complying with the Executive Order. The effect of this rulemaking would be to reduce the cost of compliance to the regulated community while maintaining the current level of protection to public health and welfare and to the environment. 1. 2 REGULATORY BACKGROUND The Oil Pollution Prevention regulation, at 40 CFR part 112, outlines requirements for both prevention of and response to oil spills. The changes and adjustments in this final rulemaking involve the prevention aspect of this regulation, also known as the SPCC regulation. It was originally promulgated on December 11, 1973, at 38 FR 34164, under the authority of section 311( j)( 1)( C) of the Clean Water Act (CWA). The regulation established spill prevention procedures, methods, and equipment requirements for non­ transportation­ related onshore and offshore facilities with aboveground oil storage capacity greater than 1,320 gallons (or greater than 660 gallons in a single tank), or buried underground oil storage capacity greater than 42,000 gallons. Regulated facilities are also limited to those that, because of their location, could reasonably be expected to discharge oil into the navigable waters of the United States or adjoining shorelines. The SPCC rule has been amended a number of times since its initial promulgation. On October 22, 1991, the Agency proposed another set of revisions to the SPCC rule. 3 The proposed revisions involved changes in the applicability of the regulation and the required procedures for the completion of SPCC Plans, as well as the addition of a facility notification provision. The proposed rule also reflected changes in the jurisdiction of section 311 of the CWA made by amendments to the Act in 1977 and 1978. On February 17, 1993, the Agency again proposed further clarifications and technical changes to the SPCC rule. 4 The proposed changes involved contingency plans, training, and methods of ensuring against brittle fracture. On December 2, 1997, the Agency proposed its latest set of changes to the SPCC rule. 5 The proposed changes were intended to reduce the information collection burden of the rule. The purpose of this final rule is to address the proposed revisions made in the October 22, 1991 proposal, the February 17, 1993 proposal, and the December 1997 proposal. 6 33 U. S. C. 1321( j)( 1)( C). 7 56 FR 54757 (October 22, 1991), superseding Executive Order 11735, 38 FR 21243. 4 EPA is finalizing the revisions to the Oil Pollution Prevention regulation to reduce its information collection burden and to clarify the intent of the existing regulation. The changes pertain to the prevention aspects of 40 CFR part 112. 1.3 STATUTORY AUTHORITY Section 311( j)( 1)( C) of the CWA authorizes the President to issue regulations establishing procedures, methods, equipment, and other requirements to prevent discharges of oil from vessels and facilities and to contain such discharges. 6 The President has delegated the authority to regulate non­ transportation­ related onshore facilities under section 311( j)( 1)( C) of the Act to EPA under Executive Order 12777, section 2( b)( 1). 7 By this same Executive Order the President has delegated authority over transportation­ related onshore facilities, deepwater ports, and vessels to the U. S. Department of Transportation (DOT) and authority over other offshore facilities, including associated pipelines, to the U. S. Department of the Interior (DOI). A subsequent Memorandum of Understanding (MOU), dated February 3, 1994, among EPA, DOT, and DOI, reallocated the responsibility for non­ transportation­ related offshore facilities that are landward of the coast line to EPA. An earlier MOU between the Secretary of Transportation and the EPA Administrator, dated November 24, 1971 (36 FR 24080), established the definitions of non­ transportation­ related facilities and transportation­ related facilities. 1. 4 REVISIONS TO 40 CFR PART 112 EPA is finalizing a number of changes to the SPCC rule. Only a limited number of these changes are expected to have a measurable effect on the burden associated with reporting and recordkeeping activities. The majority of changes being made that are expected to affect burden­ related activities are designed to reduce reporting and recordkeeping burdens for SPCC­ regulated facilities. The following changes are expected to have a measurable effect on respondent burden: ° Final 40 CFR 112.1( d)( 2)( i) and 112.1( d)( 4). EPA is no longer regulating under the SPCC program a completely buried tank that is subject to all of the technical requirements of 40 CFR part 280 or of a State program approved under 40 CFR part 281. ° Final 40 CFR 112.1( d)( 2)( ii). EPA is no longer regulating a facility having a single container with a storage capacity greater than 660 gallons, but aggregate aboveground storage capacity of 1, 320 gallons or less of oil. 5 ° Final 40 CFR 112.1( d)( 5). EPA is no longer regulating any container with a storage capacity of less than 55 gallons of oil. ° Final 40 CFR 112.1( d)( 6). EPA is no longer regulating wastewater treatment facilities or parts thereof (except at oil production, oil recovery, and oil recycling facilities) used exclusively for wastewater treatment and not used to meet any other requirement of part 112. ° Final 40 CFR 112.1( f). EPA is granting its Regional Administrators the authority to require any facility subject to the jurisdiction of EPA under section 311( j) of the CWA, but otherwise exempt from the requirement to prepare an SPCC Plan under part 112, to prepare and implement a total or partial SPCC Plan where necessary to carry out the purposes of the CWA. ° Final 40 CFR 112.3( a). EPA is requiring an SPCC­ regulated facility to amend its SPCC Plan to conform with the new sequence and requirements of the final rule, if necessary, within six months of the effective date of the final rule and to implement the Plan within 12 months. ° Final 40 CFR 112.3( e)( 1). EPA is changing from eight hours to four hours the minimum number of hours that a facility must be attended for a facility to be required to maintain a copy of an SPCC Plan on the premises. ° Final 40 CFR 112.4( a). EPA is changing the threshold for submission of information following certain discharges and is reducing the amount of information that must be submitted to the Agency after such discharges. ° Final 40 CFR 112.5( b) and (c). EPA is changing the Plan review period from three to five years and is requiring the owner or operator of a facility to document the completion of the review and evaluation. A Professional Engineer's (PE) certification of a Plan amendment will now only be required for technical changes made to the Plan. ° Final 40 CFR 112.7( a)( 2). EPA is allowing a facility to deviate from most substantive requirements if the owner or operator explains his reasons for nonconformance and provides equivalent environmental protection. ° Final 40 CFR 112.7( a)( 3). EPA is requiring an SPCC­ regulated facility to include with its Plan a facility diagram, which must mark the location and contents of each container. 6 ° Final 40 CFR 112.7. EPA is allowing an owner or operator to use an alternate format from that specified in the rule if the format is acceptable to the Regional Administrator, meets all applicable rule requirements or is supplemented so that it does, and is cross­ referenced to those requirements. ° Final 40 CFR 112.7( d). EPA is exempting the owner or operator of a facility which has submitted a Facility Response Plan (FRP) from the requirement to provide a contingency plan and a written commitment of manpower, equipment, and materials to expeditiously control and remove any quantity of discharged oil that may be harmful. ° Final 40 CFR 112.7( e). EPA is allowing records of inspections and tests kept under usual and customary business practices to suffice for records of inspections and tests required under part 112. ° Final 40 CFR 112.7( i). EPA is requiring the owner or operator to evaluate a field­ constructed aboveground container for risk of discharge or failure due to brittle fracture or other catastrophe when the container undergoes a repair, alteration, or a change in service that might affect the risk of brittle fracture or other catastrophe. 1. 5 ORGANIZATION OF THE ECONOMIC ASSESSMENT The remainder of this report is organized as follows: ° Chapter 2 presents the methodology used by EPA to produce the results reached in this report; ° Chapter 3 discusses the estimated costs of the rule's final revisions; ° Chapter 4 summarizes the benefits of the final regulation; and ° Chapter 5 presents a summary of the impact of this rulemaking on small businesses. 7 CHAPTER 2 METHODOLOGY This chapter presents the methodology used to estimate the economic effects of the final revisions to the Oil Pollution Prevention regulation. Section 2. 1 summarizes the general approach followed in calculating the economic effects. Section 2. 2 presents the baseline for the analysis. Section 2. 3 describes the classification of the final revisions to the regulation into four categories for purposes of quantifying the economic effects of the proposed revisions. Section 2.4 discusses the manner in which the number and size distribution of affected facilities is estimated, and how this estimate factors into the analysis. Section 2. 5 summarizes the process used to estimate the unit costs of compliance to facilities. Finally, Section 2. 6 presents how the total annual costs of the final revisions are calculated. 2. 1 GENERAL APPROACH The first step in analyzing the economic effects of the final revisions to the Oil Pollution Prevention regulation is to develop the baseline for the analysis, which is the benchmark from which changes in regulatory behavior (caused directly or indirectly by the final regulation) are measured. In general, the baseline is a projection of regulated facility behavior in the absence of the new regulatory provisions. After establishment of the baseline, each regulatory revision is classified into one of five categories: baseline, cost increase, negligible increase, cost savings, or negligible savings. Revisions classified as baseline are assumed to produce no substantive change in the existing regulation or to be already adhered to as good engineering practices or prevailing industry standards or practices. Revisions classified as negligible increases or negligible savings are expected to result in small and generally unmeasurable costs or cost savings per facility or to affect only a small subset of SPCC­ regulated facilities. Revisions that may result in more significant costs or costs savings to facilities are categorized as cost increases or cost savings, respectively. Next, the number of affected facilities is estimated by size category to allow the analysis to account for differences in the potential costs experienced by different sizes of facilities. Unit costs of compliance are then estimated for certain revisions. Unit costs vary by facility size (small, medium, and large), as appropriate. The final step in the methodology is to combine information on the number and size of affected facilities with information on unit costs to estimate the total annual costs of the final revisions. Exhibit 2­ 1 provides an overview of the approach used to estimate the economic effects of the final revisions to the Oil Pollution Prevention regulation. The remainder of this 8 chapter provides greater detail on the steps in the methodology; Chapters 3 and 4 discuss the costs and benefits of the final regulation. 9 Develop baseline for the analysis. Classify regulatory revisions as baseline, cost increase, negligible increase, cost savings, and negligible savings. Estimate the number and size distribution of affected facilities. Estimate unit costs of compliance for certain revisions, varying unit costs by facility size as appropriate. Estimate total first­ year and subsequentyear costs of the final revisions. EXHIBIT 2­ 1 OVERVIEW OF THE APPROACH FOR ESTIMATING THE ECONOMIC EFFECTS OF THE PROPOSED REVISIONS TO THE OIL POLLUTION PREVENTION REGULATION In addition to the analyses shown here, this EA contains a discussion of the potential effects of the revisions on small businesses (Chapter 5). 10 2. 2 BASELINE FOR THE ANALYSIS The incremental costs of this final regulation are calculated relative to a baseline of current behavior. The term "baseline" is shorthand for the projection of public and private sector behavior in the absence of the new regulatory provisions. Office of Management and Budget and EPA regulatory guidelines recommend that the effects of regulatory alternatives be measured relative to the effects of behavior in the absence of the proposed alternatives. Thus, the baseline: ° Provides a point of comparison for estimating the effects of different regulatory alternatives. The baseline should not include the effects of the final regulation; this would render the evaluation of the regulation meaningless and lead to an assessment of the regulation as having no positive or negative effects. ° Does not necessarily represent current industry practices or behavior, although such practices or behavior might be reflected in the baseline. ° Is a projection, but not necessarily a prediction, of behavior; as such, the baseline represents a hypothetical, anticipated situation. ° Should be constructed for purposes of evaluating only the effects of the regulatory alternatives. It should not be designed to evaluate the effects of the enabling statute, the existing regulation that would be modified by the final regulation, or other existing regulations. Because this analysis estimates only the incremental effects associated with the final regulatory changes, a natural choice for the baseline would be full regulated party compliance with current regulatory requirements. However, the possibility that current industry practices, behavior, or standards may exceed current regulatory requirements also needs to be considered to accurately measure the true incremental effects of the final rulemaking. If current industry standards exceed current regulatory requirements, for example, the estimated costs to industry of complying with the final new requirements may be lower if current industry standards are incorporated in the baseline. Projections of activity in the absence of the final revisions, therefore, could be based on current regulatory requirements, current industry standards, or some combination of the two. For the purpose of this report, the baseline is assumed to be full compliance by regulated facilities with the current regulation, as well as industry behavior, practices, or standards that exceed the current regulation. When industry behavior or practices exceed the current regulatory requirements, actions beyond those taken to meet the current government requirements generally are voluntary. Voluntarily incurred costs are not attributable to the final rule because they would have occurred even in the 11 absence of the final revisions and, therefore, cannot be judged to have been caused by the regulation. When industry behavior or practices fall short of the current regulatory requirements, the costs to industry of complying with the current regulatory requirements are attributable to the current regulatory requirements, not to the final regulation. If the costs of complying with the current regulation were included in the costs of complying with the final regulation, then the costs of the original rule would be counted twice (once in the analysis supporting the original rule and once in the analysis supporting the final rule). For the most part, the extent to which regulated facilities will be affected by specific revised provisions has been determined by expert judgment. For example, as described in Section 3. 3. 13, to estimate the number of facilities affected by paragraph 112.7( i), EPA relied on the judgment of engineers familiar with SPCC­ regulated facilities. The Regional EPA personnel who participated in the rulemaking workgroup have conducted SPCC inspections and evaluated SPCC Plans for many years. In addition, during the development of the proposed rules, EPA reviewed a sample of 113 inspection reports from five States, as well as two earlier studies of SPCC inspections and deficiency notices. As described in Section 3. 3. 10, EPA's estimate of the number of facilities affected by paragraph 112.7( a)( 3) was based on its experience with facility inspections. Many industry trade groups and national safety organizations have standards and guidelines relating to the storing, handling, and transfer of flammable and hazardous materials, including oil. The good engineering practices and prevention and control measures currently required by the Oil Pollution Prevention regulation include the application of appropriate industry standards. Furthermore, industry standards generally are developed through the concurrence of a majority of the firms in the relevant industry, so adherence to these standards may be considered widespread. Current regulatory requirements, as discussed in Chapter 1, include those in 40 CFR part 112. Changes from "should" to "shall" to "must" in 40 CFR part 112.7 (reorganized as 40 CFR parts 112.7 ­ 112.15 in the final revisions) do not require evaluation, because these changes are assumed to be clarifications of existing requirements rather than substantive changes. Changes from "should" to "must," therefore, are subsumed in the baseline. The preamble to the final rule states: Section 112.3 of the SPCC rule has always required that SPCC Plans be prepared in accordance with §112.7, which in turn requires that Plans be prepared in accordance with good engineering practice. However, clarification of the existing rule is necessary because of confusion on the part of some facility owners or operators who have interpreted the current rule's use of the words "should" and "guidelines" 12 in §112.7 as an indication that compliance with the applicable provisions of the rule is optional. The rule used the words "should" and "guidelines" to provide flexibility for facilities with unique circumstances. Those circumstances might be such that mandated regulatory provisions would not be in accord with good engineering practice. Therefore, the rule gave facilities the opportunity to provide alternative methods that achieve equivalent environmental protection, or to show that the provisions were inapplicable based on specific circumstances. In 1991, we proposed to clarify that misunderstanding by generally substituting "shall" in place of "should" throughout the reorganized rule. In today's final rule, we have editorially changed "shall" to "must" in furtherance of the Agency's "plain language" objectives. The "shall" to "must" is not a substantive change, but merely an editorial change. Nor will the change add to the information collection burden. We have always included requirements prefaced by "should" in the information collection burden for the rule. We will continue to provide flexibility for an owner or operator who can explain his reasons for nonconformance with rule requirements, and can provide alternate measures from those specified in the rule, which achieve equivalent environmental protection. It is possible that some facilities have misinterpreted the existing regulation and are not currently in full compliance with existing requirements, but there is no practical way to measure the level of non­ compliance. Moreover, as discussed above, the costs of coming into compliance with the clarified requirements are not properly attributed to this final regulation. The baseline used in this analysis also assumes full compliance with other current regulations that are related to the Oil Pollution Prevention regulation, including regulations issued by the Occupational Safety and Health Administration, the U. S. Coast Guard, and EPA's Underground Storage Tank (UST) program. Where current industry standards meet or exceed the existing regulatory requirements, the estimated cost of the final revisions will include only the incremental cost between the current standard and the final requirement because facilities are assumed to adhere to industry standards. Some examples of industry behavior that may exceed the current regulatory requirements include compliance with the following industry standards: ° American Petroleum Institute (API) standards 620, 650, 653, and 2610; 13 ° National Fire Protection Association (NFPA) standards 30 and 30A; ° American Society of Mechanical Engineers (ASME) standard B31.3; and ° Underwriters Laboratories, Inc. (UL) standard 142. 2. 3 CLASSIFYING THE FINAL REVISIONS The final revisions to the Oil Pollution Prevention regulation include provisions that may require changes in industry behavior and other provisions that may affect the regulated community less significantly, if at all. In estimating potential economic impacts, it is necessary to isolate the regulatory changes that are likely to contribute to a measurable increase or decrease in the level of economic burden. Consequently, each of the changes in the final rule has been classified as "none," "baseline," "cost increase," "negligible increase," "cost savings," or "negligible savings." Exhibit 2­ 2 presents each revision and its classification under the final rule. Final revisions classified as "none" do not result in costs to regulated facilities. Revisions classified as "baseline" generally do not substantively change the regulatory requirements or industry behavior and, therefore, are assumed not to result in additional costs to affected facilities. A final change has been classified as part of the baseline under the following circumstances: ° If a final revision makes explicit a requirement that is implicit in the current regulation, it is considered a clarification of the existing requirements and not a substantive change. ° Changes in the regulatory language from "should" to "must" (i. e., an activity "must" be taken instead of "should" be taken) are assumed to be clarifications of the requirements, rather than substantive changes. ° Final revisions that require compliance with industry standards also are classified as part of the baseline because full compliance with industry standards is assumed. ° If the required activity is a good engineering practice that should be followed under the existing regulation, a final revision is considered part of the baseline. The existing regulation requires that all SPCC Plans be prepared according to good engineering practices (40 CFR 112.7). When a revision is not considered part of the baseline, but is unlikely to result in measurable costs or cost savings, that final revision is classified as "negligible increase" of "negligible savings." Negligible revisions have the potential to require the 14 regulated community to incur costs or cost savings, but any such costs or cost savings are judged either too small to measure or minimal in the aggregate in comparison with the total costs of the non­ negligible provisions. One example of a negligible revision is final 40 CFR 112.4( a), which reduces the amount of information that must be submitted to an EPA Regional Administrator in the event of certain discharges and raises the threshold of such discharges for reporting purposes under that section. This final revision is classified as "negligible savings" because of the very small probability that a facility will experience a discharge reportable under §112.4( a). In addition, final 40 CFR 112.5( b) requires that the facility owner or operator document both that the fiveyear SPCC Plan review was completed and whether the Plan was amended. This revision is classified as a "negligible increase" because affixing a signed statement involves a minimal burden increase to the facility owner or operator. Revisions classified as "cost savings" or "cost increases" are expected to result in measurable costs or cost savings to the regulated community. One such revision classified as a "cost savings" is 40 CFR 112.1( d)( 2)( ii). This revision exempts from the SPCC program all facilities with an aggregate storage or use capacity of 1, 320 gallons or less of oil, and excludes containers of less than 55 gallons from the calculation of a facility's aggregate storage capacity. This final revision will remove a substantial number of facilities from the scope of the SPCC program, thereby offering substantial cost savings to the regulated community. Final 40 CFR 112.1( f) is an example of a revision classified as a "cost increase." The revision gives the EPA Regional Administrator authority, when necessary, to require previously a exempted facility owner or operator to prepare a total or partial SPCC Plan. Quantitative cost estimates are developed for revisions that impose non­ negligible costs under the final rule. 15 EXHIBIT 2­ 2 CLASSIFICATION OF REVISIONS TO THE OIL POLLUTION PREVENTION REGULATION Final Section of 40 CFR part 112 Final Rule Burden Classification Capital Requirements Comments 112.1 General applicability 112.1( a) Expands the geographic scope of the rule to conform to CWA geographic scope. Baseline Baseline The regulatory change does not affect the number of facilities being regulated under the SPCC program because the statutory change has already been taken into account in EPA's previous economic analyses. 112.1( b) Tracks amendments to the CWA. Also clarifies that a facility using oil may also be subject to the requirements of this rule. Baseline Baseline EPA is clarifying its existing interpretation that a facility using oil operationally may also be subject to the SPCC requirements. 112.1( b) Clarifies the types of oil storage containers that EPA is regulating. Baseline Baseline EPA is merely clarifying its existing interpretation of the rule. 112.1( b)( 3) Clarifies EPA's definition of an aboveground container that is regulated, to exclude one that is permanently closed Negligible savings Negligible savings A few facilities with permanently closed containers may no longer be regulated. 112.1( c) Editorial changes to reflect deletion of §112.6. None None The revisions to this section are merely editorial and reflect the deletion of §112.6. 112.1( d)( 1)( i) and (ii) Editorial changes. Baseline Baseline These editorial changes do not affect either burden or cost calculations. 112.1( d)( 1)( iii) Clarifies that this part does not apply to a facility, equipment, or operation that is not subject to EPA jurisdiction, including a facility subject solely to DOT and DOI jurisdiction. Baseline Baseline The change reflects jurisdiction established by an MOU. EXHIBIT 2­ 2 CLASSIFICATION OF REVISIONS TO THE OIL POLLUTION PREVENTION REGULATION Final Section of 40 CFR part 112 Final Rule Burden Classification Capital Requirements Comments 16 112.1( d)( 2)( i) Clarifies that a permanently closed container and a completely buried tank subject to all of the technical requirements of 40 CFR part 280 or a State program approved under 40 CFR part 281 (UST regs) does not count in the calculation of the 42,000 gallon threshold. Cost savings Cost savings Certain facilities with USTs are no longer required to comply with SPCC provisions. Will have greater impact on new facilities that have not yet prepared Plans. 1991 EA estimated that gasoline service stations would be most affected by this rulemaking and essentially drop out of the SPCC program. Could also affect: trucking and warehousing, airports. 112.1( d)( 2)( ii) Excludes a facility having only aboveground storage capacity in a single container of more than 660 gallons, as long as the aggregate storage capacity is 1, 320 gallons or less of oil. Also excludes a container of less than 55 gallons from the calculation of a facility's total storage capacity. Cost savings Cost savings A substantial number of facilities will drop out of the SPCC program as a result of the threshold revision. To a much lesser extent, a few facilities may also drop out because the exemption for a container of less than 55 gallons may cause the aggregate storage capacity to be 1320 gallons or less. 112.1( d)( 3) Exempts a facility subject to MMS jurisdiction as specified in the 1993 MOU. Baseline Baseline EPA has not included these facilities in its economic analyses of the program since the MOU was signed. 112.1( d)( 4) Exempts a completely buried tank subject to all of the technical requirements of 40 CFR part 280 or a State program approved under 40 CFR part 281 from SPCC. Negligible savings Negligible savings The scope of some Plans will be reduced if they no longer need to include certain completely buried tanks. 112.1( d)( 5) Exempts bulk storage containers with a capacity of less than 55 gallons of oil from the program. Negligible savings Negligible savings The scope of some Plans will be reduced if they no longer need to include small containers. EXHIBIT 2­ 2 CLASSIFICATION OF REVISIONS TO THE OIL POLLUTION PREVENTION REGULATION Final Section of 40 CFR part 112 Final Rule Burden Classification Capital Requirements Comments 17 112.1( d)( 6) Exempts certain wastewater treatment facilities or parts thereof from the rule, (except at oil production, oil recovery, and oil recycling facilities), if used exclusively for wastewater treatment and not used to meet any other requirement of part 112. Cost savings Cost savings As a result of the final rule, certain facilities will recalculate their storage capacity to exclude oil capacity from applicable wastewater treatment systems. Some facilities will no longer be regulated due to a reduction in applicable storage capacity. Initially or within the first year, facilities will expend burden and capital costs to assess and certify attainment of SPCC exemption criteria. Exempt facilities will realize cost savings in subsequent years. 112.1( e) Minor editorial changes. Baseline None 112.1( f) Gives the RA authority to require preparation of a total or partial SPCC Plan, for previously exempted facilities, when necessary to carry out the purposes of the CWA. Cost increase Cost increase 1993 NPRM EIA estimated that about 100 facilities would be affected annually, 60 small, 30 medium, and 10 large. 112.2 Definitions 112.2 Expands the current definitions in the SPCC regulations. Baseline Baseline EPA is merely clarifying currently used terms and definitions. 112.3 Requirement to prepare and implement Spill Prevention, Control, and Countermeasures Plan 112.3( a) Requires a facility already in operation to amend its Plan, if necessary, within 6 months of the effective date of this part, and to implement the Plan within 12 months. Negligible increase None Although facilities will incur a burden to read and understand the changes being made to the SPCC rule, few facilities will need to amend their Plans as a result of the changes. EXHIBIT 2­ 2 CLASSIFICATION OF REVISIONS TO THE OIL POLLUTION PREVENTION REGULATION Final Section of 40 CFR part 112 Final Rule Burden Classification Capital Requirements Comments 18 112.3( b) Requires a new facility to fully prepare and implement its Plan before beginning operations. Negligible increase None In the period between when a facility is constructed and when it begins operations, there should be enough time to implement the SPCC Plan. It is unlikely that this provision would delay the start of operations. 112.3( c) Editorial changes. Baseline None 112.3( d) Adds specificity to PE certification by requiring that the PE certify that inspection and testing procedures have been established, industry standards have been considered, and that the Plan is adequate for the facility. Allows the PE's agent to visit and examine the facility. Baseline None Although the proposed rule adds some specificity to the PE's responsibility, these requirements are not assumed to go beyond the current requirement that a Plan shall be prepared in accordance with good engineering practices. 112.3( e) Lowers from eight to four hours the minimum number of hours a facility must be attended to be required to have a complete Plan on site each day. Baseline None No net change in the number of Plans. Some facility types, especially E& P, may have to move the Plans from field offices to the facility if it is attended more than four hours a day. 112.3( f) Gives an RA authority to grant an extension of time for the preparation and full implementation of a Plan or amendments and deletes current requirement that a facility must submit a complete copy of its Plan along with its request to the RA. Negligible savings None Analyses assume that facilities incur planning and implementation costs in same year that they become regulated and that, on average, even with an extension, Plan preparation and implementation costs will still be incurred during that year. EXHIBIT 2­ 2 CLASSIFICATION OF REVISIONS TO THE OIL POLLUTION PREVENTION REGULATION Final Section of 40 CFR part 112 Final Rule Burden Classification Capital Requirements Comments 19 112.4 Amendment of Spill Prevention, Control, and Countermeasures Plan by Regional Administrator 112.4( a) Reduces the information that must be submitted to an RA in the event of certain oil discharges and raises the threshold for the size of discharges that trigger submission. Negligible savings None Two areas of burden reduction result: 1) only facilities that experience two or more 42­ gallon discharges on a rolling basis (as opposed to two or more reportable discharges of any size) must submit information to RA; and 2) the amount of information that EPA is requiring facilities to submit is reduced ­ namely facilities no longer have to submit the entire Plan. Negligible cost savings because few facilities experience two or more reportable discharges within these time periods. 112.4( b) Clarifies that facility need not comply with §112.4 until Plan is fully implemented. Negligible increase None As stated in §112.3( b), new facilities must prepare and implement Plans before beginning operations, so they will be subject to §112.4 (submitting information after certain discharges) before beginning operations. But few facilities will be affected by extended Plan preparation and implementation periods. 112.4( c) Requires that Plans be sent to appropriate State agency( ies) in charge of oil pollution control activities. Negligible increase None In some States, a facility may have to send copies of its Plan to more than a single State agency if State has more than a single agency in charge of oil pollution control activities. But few facilities will be affected because only a few will have to provide additional information. 112.4( d) Clarifies that the RA can require an SPCC Plan to be amended after an on­ site review. Baseline None The cost to amend a Plan is not counted because it is already captured in the baseline under the assumption that all SPCC­ regulated facilities prepare complete Plans. EXHIBIT 2­ 2 CLASSIFICATION OF REVISIONS TO THE OIL POLLUTION PREVENTION REGULATION Final Section of 40 CFR part 112 Final Rule Burden Classification Capital Requirements Comments 20 112.4( e) and (f) Several editorial changes. Baseline None 112.5 Amendment of Spill Prevention, Control, and Countermeasures Plan by owners or operators 112.5( a) Several editorial changes and a change in timing of Plan amendment. Also provides examples of types of facility changes that may trigger an amendment. Negligible savings Negligible savings Allows up to 12 months, rather than 6 months, to implement an amendment after a material change at the facility. 112.5( b) Changes period for Plan review by owner or operator from 3 to 5 years. Requires owner or operator to document that a review was completed and whether the Plan was amended. Cost savings Negligible increase None None Expanding the review period from 3 to 5 years will reduce the annualized burden for review activities by approximately 40% annually. Affixing a signed statement certifying the review has taken place involves a minimal increase in the burden to review a Plan. 112.5( c) Amends section to require PE approval only for technical Plan amendments. Negligible savings None Owners or operators no longer need to obtain PE certification when making non­ technical changes to Plan . 112.7 Spill Prevention, Control, and Countermeasures Plan general requirements 112.7 States that a Plan must be prepared in writing and in accordance with the sequence specified in this section, unless an equivalent prevention Plan acceptable to the Regional Administrator has been prepared, in which case it must be supplemented with a cross­ reference. Cost savings Cost increase None Allows a facility to cross­ reference similar SPCC provisions in existing federal, State, or other plans to reduce paperwork­ related burden. An "equivalent" plan might include a State plan, ICP, or other format. Most existing facilities, however, will need to supplement their Plan with a cross­ reference. A cross­ reference template is provided in the preamble, which will keep burden increase to a minimum. EXHIBIT 2­ 2 CLASSIFICATION OF REVISIONS TO THE OIL POLLUTION PREVENTION REGULATION Final Section of 40 CFR part 112 Final Rule Burden Classification Capital Requirements Comments 21 112.7( a) Deletes requirement that Plan must include a description of pre­ 1974 spill events. Negligible Savings None Deleting requirement results in a negligible burden reduction because existing facilities would have already included such a description in their Plans. 112.7( a)( 2) Editorial Changes. Baseline Baseline 112.7( a)( 3) Requires the Plan to include a description of the physical plant, other site specific information, spill control information, and spill countermeasure information. Also requires that the Plan note the location and contents of oil in each container. Cost increase None Many facilities may already have a diagram, in accordance with good engineering practice. A diagram is needed to project spill trajectories, to assist facility personnel in performing periodic inspections, and to assist in response efforts. Some facilities, mostly small ones, will have to add a diagram to their Plans. 112.7( a)( 4) Requires that information in the Plan enable a person reporting a discharge as described in §112.1( b) to provide all relevant facility and spill information and actions being used to stop, remove, and mitigate the effects of the discharge. Baseline None Clarification of existing requirement that all SPCC Plans be prepared according to good engineering practice. 112.7( a)( 5) Requires that portions of the Plan describing procedures used after a discharge be organized in a manner to make them readily usable. Baseline None The provision does not go beyond the current requirement to prepare the Plan in accordance with good engineering practice. 112.7( b) Editorial changes. Baseline None 112.7( c) Requires secondary containment system to prevent a discharge as described in §112.1( b). Baseline None Clarification of existing requirement. This addition does not necessarily make the regulation more stringent because it is intended to reflect industry practice. EXHIBIT 2­ 2 CLASSIFICATION OF REVISIONS TO THE OIL POLLUTION PREVENTION REGULATION Final Section of 40 CFR part 112 Final Rule Burden Classification Capital Requirements Comments 22 112.7( d) Requires that if the installation of structures (e. g., secondary containment) or equipment listed in this section is not practicable, the owner or operator must explain such impracticability and conduct periodic integrity tests of containers; and periodic integrity and leak testing of valves and piping. Requires a contingency plan and commitment of manpower, equipment, and material unless an FRP was submitted. Negligible savings None For those facilities that determine that such structures are impracticable, periodic testing means in accordance with industry standards (e. g., API 653). The provision does not impose additional burden on facilities because they were required to follow good engineering practices. Facilities with FRPs no longer have to have a contingency plan following part 109. 112.7( e) Allows use of usual and customary business records to serve when a record of inspections or tests is required pursuant to part 112. Cost savings None By allowing usual and customary business records to meet the recordkeeping requirements for testing, the time spent by facilities to perform Plan maintenance and recordkeeping activities is diminished (e. g., NPDES records of stormwater bypass events, API 653 and 2610). (Effect estimated in 1997 proposed rule ICR.) 112.7( f)( 1) Requires an owner or operator to train oil handling personnel in the operation and maintenance of equipment, discharge procedure protocols, pollution control laws, facility operations, and the Plan. Baseline None EPA is modifying current requirement to clarify that only oil­ handling personnel need to be trained and is specifying additional training subjects. This is merely a clarification of good engineering practice. 112.7( f)( 2) Editorial changes. Baseline None 112.7( f)( 3) Requires an owner or operator to schedule and conduct a discharge prevention briefing for oil handling personnel at least once a year. Baseline None Clarifies existing rule to require that discharge prevention briefing must occur at least yearly. 112.7( g)( 1) Editorial changes. None Baseline EXHIBIT 2­ 2 CLASSIFICATION OF REVISIONS TO THE OIL POLLUTION PREVENTION REGULATION Final Section of 40 CFR part 112 Final Rule Burden Classification Capital Requirements Comments 23 112.7( g)( 2) Mostly editorial changes. None Negligible savings Current §112.7( e)( 9)( 2) requires locks on valves. Revision gives facilities discretion of alternative security measures. 112.7( g)( 3) Editorial changes. None Baseline 112.7( g)( 4) Editorial changes. None Baseline 112.7( g)( 5) Editorial changes. None Baseline 112.7( h)( 1) Deletes requirement to comply with DOT provisions. Negligible decrease Baseline Plan no longer needs to discuss this requirement. 112.7( h)( 2) Requires a warning sign or other device to prevent vehicular departure before detachment of transfer lines. None Negligible savings Additional allowable methods may lead to some cost savings for a small number of facilities having tank car and tank truck loading and unloading racks. This is merely a clarification of the existing requirement. 112.7( h)( 3) Editorial changes. Baseline None 112.7( i) Requires a field­ constructed container to be evaluated for risk of failure due to brittle fracture or other catastrophic failure after it undergoes repair, alteration, or a change in service that may affect the risk of failure, and appropriate action must be taken. Cost increase Negligible increase This evaluation applies only to field­ constructed aboveground containers.. 112.7( j) Editorial changes. Baseline None EXHIBIT 2­ 2 CLASSIFICATION OF REVISIONS TO THE OIL POLLUTION PREVENTION REGULATION Final Section of 40 CFR part 112 Final Rule Burden Classification Capital Requirements Comments 24 112.8 Spill Prevention, Control, and Countermeasures Plan requirements for onshore facilities (excluding production facilities) 112.8( a) References the general requirements all facilities must meet and the specific requirements that facilities in this category must meet. None None Re­ organization of current §112.7. 112.8( b)( 1) Editorial changes. Baseline None 112.8( b)( 2) Editorial changes. None Baseline 112.8( b)( 3) Requires that drainage systems from undiked areas that have a potential for an oil discharge be designed so that discharged oil flows into ponds, lagoons, or catchment basins designed to hold the oil. Catchment basins must not be located in areas subject to periodic flooding. None Negligible savings Clarifies that design requirements for facility drainage systems are applicable only for those undiked areas susceptible to oil discharges. 112.8( b)( 4) Editorial changes. Baseline Baseline 112.8( b)( 5) Editorial changes. Baseline Baseline 112.8( c)( 1) Editorial changes. Baseline Baseline 112.8( c)( 2) Editorial changes. Baseline Baseline EXHIBIT 2­ 2 CLASSIFICATION OF REVISIONS TO THE OIL POLLUTION PREVENTION REGULATION Final Section of 40 CFR part 112 Final Rule Burden Classification Capital Requirements Comments 25 112.8( c)( 3) Allows records required for NPDES permit regulations or other similar customary business records to beused to record stormwaterbypass events for SPCC purposes. Cost savings None Owner or operator may use records already generated under NPDES rules to serve for SPCC purposes. (This rule section is providing a specific example of how ordinary business records may suffice for records of inspections and tests (§ 112.7( e)). In the 1997 Economic Analysis, EPA estimated that 16,300 oil storage and production facilities would be impacted. Savings already included under §112.7( e). 112.8( c)( 4) Editorial changes. Baseline Baseline 112.8( c)( 5) Requires avoiding the use of partially buried or bunkered metallic tanks for the storage of oil, unless the buried section of the shell is protected by coatings or cathodic protection. None Negligible savings Clarifies that partially buried tanks may be protected by cathodic protection, in addition to coatings. 112.8( c)( 6) Requires that an aboveground container be tested for integrity on a regular basis and when material repairs are done. Testing must combine visual inspection along with another testing technique. Allows records of inspections and tests kept pursuant to usual and customary business practices to suffice for purposes of this section. None Cost savings Baseline None Currently required as part of "good engineering practice." API 653, which represents current industry standards for tank inspection and repair, already requires this. Savings already included under 112.7( e). 112.8( c)( 7) Editorial changes. Baseline Baseline 112.8( c)( 8) Editorial changes. None Baseline 112.8( c)( 9) Editorial changes. Baseline None EXHIBIT 2­ 2 CLASSIFICATION OF REVISIONS TO THE OIL POLLUTION PREVENTION REGULATION Final Section of 40 CFR part 112 Final Rule Burden Classification Capital Requirements Comments 26 112.8( c)( 10) Requires that a visible discharge of oil be promptly corrected and that any accumulation in a diked area be promptly removed. Negligible increase Negligible increase Modification to existing requirement under present §112.7( e)( 2)( x), which only requires leaks causing accumulations in diked areas to be promptly corrected. Correction of all visible leaks, however, is standard industry practice under API 653. 112.8( c)( 11) Requires that mobile or portable oil storage container be positioned to prevent a discharge and that a secondary means of containment, sufficient to contain the capacity of the largest single compartment or container (plus freeboard) be furnished. Negligible savings Negligible savings Modifies existing requirement that such facilities are no longer required to be located where they will not be subject to periodic flooding and Plans no longer need to address this. Sufficient freeboard is part of good engineering practice. 112.8( d)( 1) A new or replaced buried piping installation must be provided with a protective wrapping and coating and must be cathodically protected unless the corrosion protection standards in part 280 of this chapter are satisfied. Any exposed section of a buried line must be examined and corrective action must be taken. Negligible increase Negligible increase Modification to existing requirement. New requirements are only for new or replaced piping installations but cathodic protection applies to all soil conditions. 112.8( d)( 2) Editorial changes. None Baseline 112.8( d)( 3) Editorial changes. None Baseline 112.8( d)( 4) Requires conducting integrity and leak testing of buried piping at the time of installation, modification, construction, relocation, or replacement. None Baseline Considered a good engineering practice (e. g., API 2610). 112.8( d)( 5) Editorial Changes. None Baseline EXHIBIT 2­ 2 CLASSIFICATION OF REVISIONS TO THE OIL POLLUTION PREVENTION REGULATION Final Section of 40 CFR part 112 Final Rule Burden Classification Capital Requirements Comments 27 112.9 Spill Prevention, Control, and Countermeasures Plan for onshore production facilities 112.9( a) References the general requirements all facilities must meet as well as the specific requirements facilities in this category must meet. None None Reorganization of the rule. 112.9( b)( 1) Editorial changes. Cost savings Baseline References §112.8( c)( 3). Savings already included under §112.7( e). 112.9( b)( 2) Editorial changes. None Baseline 112.9( c)( 1) Editorial changes. None Baseline 112.9( c)( 2) Requires a secondary means of containment for the entire contents of the single largest tank in use and sufficient freeboard to allow for precipitation. None Baseline Clarifies an existing requirement. Sufficient freeboard falls under good engineering practices as documented API Standard 2610, section 7. 2. 2. 112.9( c)( 3) Requires all containers to be visually examined for deterioration and maintenance on a scheduled periodic basis. The examination must include the foundation and supports of tanks that are on or above the surface of the ground. Negligible increase Negligible increase Clarifies an existing requirement. Visual examinations must include foundations and supports of tanks that are on the ground in addition to those that are above the ground. 112.9( c)( 4) Editorial changes. None Baseline 112.9( d)( 1) Editorial changes. Baseline None 112.9( d)( 2) Editorial changes. Baseline None 112.9( d)( 3) Editorial changes. Baseline Baseline EXHIBIT 2­ 2 CLASSIFICATION OF REVISIONS TO THE OIL POLLUTION PREVENTION REGULATION Final Section of 40 CFR part 112 Final Rule Burden Classification Capital Requirements Comments 28 112.10 Spill Prevention, Control, and Countermeasures Plan requirements for onshore oil drilling and workover facilities 112.10( a) References the general requirements all facilities must meet as well as the specific requirements facilities in this category must meet. None None Reorganization of the rule. 112.10( b) Editorial changes. None Baseline 112.10( c) Editorial changes. None Baseline 112.10( d) Editorial changes. None Baseline 112.11 Spill Prevention, Control, and Countermeasures Plan requirements for offshore oil drilling, production, or workover facilities. 112.11( a) References the general requirements all facilities must meet as well as the specific requirements facilities in this category must meet. None None Reorganization of the rule. 112.11( b) Editorial changes. None Baseline 112.11( c) Editorial changes. None Baseline 112.11( d) Editorial changes. None Baseline 112.11( e) Editorial changes. None Baseline 112.11( f) Editorial changes. None Baseline 112.11( g) Editorial changes. None Baseline 112.11( h) Editorial changes. Baseline None EXHIBIT 2­ 2 CLASSIFICATION OF REVISIONS TO THE OIL POLLUTION PREVENTION REGULATION Final Section of 40 CFR part 112 Final Rule Burden Classification Capital Requirements Comments 29 112.11( i) Requires simulated spills for testing and inspecting human and equipment pollution control and countermeasure systems. Baseline Baseline Clarification of existing requirement. Simulated spill testing requirement is also a clarification of existing practices. 112.11( j) Editorial changes. Baseline None 112.11( k) Editorial changes. None Baseline Deletes present §112.7( e)( 7)( xii), which requires extraordinary well control measures to be provided should emergency conditions occur. None Negligible savings This language is being made a preamble recommendation. 112.11( l) Editorial changes. None Baseline 112.11( m) Editorial changes.. None Baseline 112.11( n) Editorial changes. None Baseline 112.11( o) Editorial changes. None Baseline 112.11( p) Requires sub­ marine piping to be maintained in good operating condition and tested or inspected on a scheduled periodic basis. Such tests or inspections must be documented and records must be kept in the facility. Baseline Negligible savings Clarification of existing requirement, although requirement is amended to allow testing instead of inspection. 112.12 ­ 112.15 (Subpart C) Repeats requirements found under §§ 112.8 112.11 for animal fats and vegetable oils. Baseline Baseline EPA is merely clarifying the applicability of the SPCC rule for these oil types. 112.20( h) Provides that a response plan must follow the format of the model facility­ specific response plan unless an equivalent response plan has been prepared that is acceptable to the Regional Administrator. Baseline None Revision is intended to track SPCC language in §112.7 and is intended as an editorial change, not a substantive one. 8 EPA conducted the following two surveys to determine the scope and characteristics of the regulated community: (1) U. S. Environmental Protection Agency, Spill Prevention, Control, and Countermeasures Facilities Study, January 1991; and (2) U. S. Environmental Protection Agency, Analysis of the Number of Facilities Regulated by EPA's SPCC Program, 1996. 30 2.4 ESTIMATING THE NUMBER AND SIZE DISTRIBUTION OF AFFECTED FACILITIES Estimating the economic effects of the final revisions first requires an assessment of the regulated community. Extensive studies were conducted to characterize the facilities that exceed the Oil Pollution Prevention regulation underground and aboveground oil storage capacity thresholds. 8 For the purposes of this analysis, the results of these studies are presented in terms of: °Thenumber of facilities above the Oil Pollution Prevention regulation oil storage capacity thresholds; °Thesize of these facilities, in terms of tank storage capacity and number of containers at each facility; and °Thecategory of facility. The aggregate effects of some regulatory revisions depend not only on the total number of facilities meeting the capacity thresholds, but on other factors such as facility size. Therefore, data are organized in a way that facilitates calculation of the economic effects of the final revisions. The information on the number, size, and category of affected facilities is presented in Chapter 3. The remainder of this section presents the method by which this information is assembled and used in the estimation of economic effects. Number of Facilities. For production and storage facilities in most industrial categories, the baseline number of facilities was determined by the 1995 SPCC Survey. To develop a national estimate of SPCC­ regulated facilities, EPA applied standard statistical techniques to the results from the 1995 SPCC Survey. The 1995 Survey was designed to ensure that data on the sampled facilities could be statistically extrapolated to the nation as a whole for all facilities regulated by EPA's SPCC regulation. To accomplish this, EPA selected facilities in industries likely to include regulated facilities. Using several national databases, facilities were randomly selected to ensure that the sample facilities reflect the actual universe of facilities that produce, use, or store oil products. EPA's approach for calculating the sample allows EPA to make statements about surveyed industries to within 10 percent of their true value and within the 90­ percent confidence interval. 9 U. S. Environmental Protection Agency, Analysis of the Number of Facilities Regulated by EPA's SPCC Program, 1996. 31 EPA used a two­ stage cluster sampling methodology. The first stage involved randomly selecting primary sampling units (PSUs) that are representative of the entire study population (e. g., selecting contiguous groups of counties that are representative of all counties in the United States). The second stage involved randomly sampling individual enumeration units (in this case facilities) from each PSU that are representative of all of the other enumeration units within that PSU. Enumeration units were then extrapolated to the PSU, or county, level and PSU­ level estimates were extrapolated to the nation as a whole. As described in the analysis titled "Analysis of the Number of Facilities Regulated by EPA's SPCC Program," however, a few industry categories were not sampled or had a response rate too low to allow extrapolation. 9 In those industry categories, estimates of the number of facilities from the 1991 SPCC Facilities Study were used to supplement the Survey totals. As shown in Exhibit 2­ 3, the 1995 Survey response rates for all industry categories that were used to estimate the number of regulated facilities were at least 50 percent and for some categories exceeded 75 percent. 10 Sources: U. S. Environmental Protection Agency, Analysis of the Number of Facilities Regulated by EPA's SPCC Program, 1996. U. S. Environmental Protection Agency, SPCC Survey Final Response Rate Chart, 1996. 32 EXHIBIT 2­ 3 Survey Response Rates for Industry Categories Used to Extrapolate the Number of Facilities 10 Industry (SIC) Total Population Surveys Delivered Responses Farms (01/ 02) 1,925,300 16,181 9,220 Mining (12/ 14) 7,959 55 38 Oil Production 210,223 461 305 Contract Construction (16) 34,332 265 150 Food and Kindred Products (20) 21,049 461 293 Chemical and Allied Products (28) 12,371 336 246 Petroleum Refining and Related Industries (29) 2,117 80 57 Primary Metal Industries (33) 6,726 114 90 Other Manufacturing 328,138 3,684 2,260 Transportation 133,262 2,255 1,315 Electric Utility Plants (491) 5,523 71 65 Petroleum Bulk Stations and Terminals (5171) 11,200 333 225 Gasoline Service Stations/ Vehicle Rental (554/ 751) 111,697 1,478 768 Fuel Oil Dealers (5983) 4,924 122 93 Hospitals/ Colleges/ Other Education (806/ 821/ 822) 27,570 1,669 875 Military Installations (97) 5, 472 163 101 33 For a few other industry categories, the Survey analysis was thought to underestimate the national number of SPCC facilities, while the Facilities Study was thought to overestimate these facilities. In these cases, the midpoint of Survey and Facilities Study estimates for these industry categories was selected for use in calculating an adjusted national estimate. Adjustments to the estimate were also made to reflect the fact that the survey design limited sampling to the 48 contiguous States. For each industry sector, EPA applied the proportion of regulated facilities for the contiguous 48 States to the total number of facilities in Hawaii. The total number of regulated facilities in Alaska was based on estimates from that State's Department of Environmental Conservation. Following this adjustment and validation process, EPA arrived at an adjusted national estimate of the number of facilities subject to the SPCC regulation for each industry category in 1995. This estimate was then inflated by a one percent annual growth rate to yield an estimate of the number of facilities subject to the SPCC regulation prior to these revisions. Facility Characteristics. For the purpose of this analysis, it is assumed, based on data contained in the 1991 SPCC Facilities Study that facilities in each size category (prior to the final revisions) have the following number of oil storage containers: ° Small facilities (total aboveground storage capacity greater than 1,320 gallons but less than or equal to 42,000 gallons) – 2 containers; ° Medium facilities (total storage capacity greater than 42,000 gallons but less than or equal to one million gallons) – 7 containers; and ° Large facilities (total storage capacity greater than one million gallons) – 17 containers. Results of the 1995 SPCC Survey are consistent with these estimates of the number of containers at an average facility in each size category. The 1995 SPCC Survey also subdivides the SPCC­ regulated facilities by Standard Industrial Classification (SIC) code among a wide variety of industry and business types. However, for purposes of this analysis, facilities were grouped into two distinct categories: production facilities (facilities whose operations and oil storage activities primarily involve oil production) and storage facilities (all other SPCC­ regulated facilities). Also, facilities were divided into existing and new facilities. Facility Category. To facilitate the use of the data, regulated facilities were categorized into several North American Industrial Classification System (NAICS) categories, including those associated with petroleum production, processing (refining), distribution, and consumption. EPA's 1995 SPCC Survey and the 1991 SPCC Facilities Study determined that the majority of regulated facilities fall into several 11 NAICS Codes and the corresponding SIC codes can be found in the Federal Register at 61 FR 57006, November 5, 1996. 34 industry sectors. These sectors and the corresponding NAICS codes are presented in Exhibit 2­ 43. EXHIBIT 2­ 4 Primary Industry Sectors and NAICS Codes Covered by the SPCC Regulation 11 CATEGORY NAICS Codes Crop and Animal Production 111­ 112 Crude Petroleum and Natural Gas Extraction 211111 Coal Mining, Non­ Metallic Mineral Mining and Quarrying 2121/ 2123/ 213114/ 213116 Electric Power Generation, Transmission, and Distribution 2211 Heavy Construction 234 Petroleum and Coal Products Manufacturing 324 Other Manufacturing 31­ 33 Petroleum Bulk Stations and Terminals 42271 Gasoline Stations/ Automotive Rental and Leasing 4471/ 5321 Heating Oil Dealers 454311 Transportation (including Pipelines), Warehousing, and Marinas 482­ 486/ 488112­ 48819/ 4883/ 48849/ 492­ 493/ 71393 Elementary and Secondary Schools, Colleges 6111­ 6113 Hospitals/ Nursing and Residential Care Facilities 622­ 623 Estimation of the number of facilities by industry category and size group allows the economic analysis to reflect costs that vary by industry or size, thereby providing more detailed results. 35 2. 5 UNIT COST ESTIMATES Unit costs were developed for the non­ negligible final provisions. Unit costs to an existing facility for the finalized revisions and, where applicable, corresponding provisions are given as follows: ° Wastewater Treatment Exemption ­ §112.1( d)( 6); ° Five­ year Review ­ §112.5( b); ° Oil Discharge ­ §112.4( c); ° Plan Modification ­ §112.5( a); ° Recordkeeping ­ §112.7( e); ° Cross­ Reference Matrix ­ §112.3( a); ° Facility Diagram ­ §112.7( a)( 3); ° Brittle Fracture Records ­ §112.7( i); and ° Costs to Read and Understand the Rule. Unit costs to a new facility for the finalized revisions and, where applicable, corresponding provisions are given as follows: ° New Plan ­ §112.3( a); ° Oil Discharge ­ §112.4( c); ° Plan Modification ­ §112.5( a); and ° Recordkeeping. 2. 6 TOTAL COSTS OF PROPOSED REVISIONS Once unit costs are established for the final revisions, the total costs are estimated by multiplying unit costs estimates by the estimated number of affected facilities. For example, the economic effect of a revision that affects each facility, independent of facility size, is estimated by multiplying the unit costs of the revision by the total number of facilities affected by the final rule. Alternatively, the cost of a final revision that depends on facility size is estimated by multiplying the number of small, medium, and large facilities by the respective unit costs that small, medium, and large facilities would likely incur in complying with the provision. Chapter 3 presents the results of the total cost calculations for the final rule and regulatory alternatives in terms of: ° First­ year costs incurred by small, medium, and large facilities; ° Subsequent­ year costs incurred by small, medium, and large facilities; and ° Aggregate costs. 36 CHAPTER 3 ESTIMATED UNIT COSTS AND TOTAL COSTS OF COMPLIANCE This chapter presents estimates of the unit costs to a facility of complying with the final revisions to the Oil Pollution regulation and provides the corresponding data and assumptions used to derive these estimates. The unit costs estimates are developed according to the general methodology described in Chapter 2 and are combined with the number of affected facilities estimated in Section 3. 4 to yield estimates of the total costs of the final revisions. As described in Chapter 2, for purposes of this Economic Analysis, the final revisions to the Oil Pollution Prevention regulation have been classified into the following five categories: baseline, cost increase, negligible increase, cost savings, or negligible savings. Baseline provisions are assumed to represent current industry practices or standards and/ or good engineering practices already required by the existing regulation. Therefore, baseline provisions are assumed to result in neither incremental costs nor benefits attributable to this final rule. Provisions classified as negligible increase or negligible savings are mandatory requirements but are assumed to impose costs on facilities that are minimal in the aggregate relative to the total costs of the non­ negligible provisions. Provisions classified as cost increase or cost savings are expected to result in non­ negligible costs or cost savings, and are estimated in this chapter. Because certain unit costs are likely to vary by facility size, this EA develops separate unit cost estimates for small, medium, and large facilities, where appropriate. Section 3. 1 outlines the data collection process used to estimate costs. Section 3. 2 presents the wage rates used in the unit cost estimates. Section 3.3 presents the unit cost estimates for facilities by provision. The universe of regulated facilities is estimated in Section 3.4. Finally, Section 3.5 details the total costs incurred by regulated facilities. 3.1 DATA COLLECTION To collect data for the estimation of unit costs, selected EPA Regional personnel, State officials, and contractor staff with experience in the existing SPCC program and a knowledge of the costs and level of effort involved in developing and implementing spill prevention programs and contingency plans were contacted. Additionally, data from the Spill Prevention, Control, and Countermeasures (SPCC) Facilities Study and a review of SPCC­ related studies provided information useful for the development of the unit cost estimates. Unit cost data were obtained from various engineering cost documents. The collection of primary data from SPCC­ regulated facilities or industry trade associations was beyond the scope of this report. 12 United States Department of Labor, Bureau of Labor Statistics, Employer Costs for Employee Compensation, March 2001. 13 Overhead costs were computed separately from BLS data and were assumed to be an additional 17 of the total wage rate, which is comprised of direct wages and salaries and employee benefits, as reported by BLS. The March 2001 wage estimates were adjusted to December 2001 estimates using the U. S. Department of Labor's December 2001 Employment Cost Index for private industry. Adjustments to wage rates for overhead costs are based on the results of several earlier Information Collection Requests that adjusted BLS wage rates by an additional 17 percent based on the results of a survey of chemical industries and trade associations. (See, for example, Information Collection Request for the Toxic Chemical Release Report for the Proposed Lead Rule, EPA ICR #1363.08.) 37 Given the number and diversity of facilities subject to the SPCC requirements, developing a set of unit cost estimates that accurately reflects the amount facilities will expend to comply with the final revisions is difficult. Unit compliance costs may vary not only by size of facility but also by container configuration, geographic location, industry, facility age, and other factors. In addition, for some final revisions in which unit costs are estimated, a facility has several alternatives regarding how it may comply. These compliance alternatives will vary on a facility­ by­ facility basis. Thus, the data collected on unit costs from regulatory officials and contractor personnel often are fragmentary and subjective. Developing a myriad of unit cost estimates that capture all factors affecting the costs of compliance with each revision, however, is beyond the scope of this report. Hence, the unit cost estimates presented below should be considered representative of the possible costs to be incurred by facilities, rather than precise estimates of the actual costs that will be incurred. 3. 2 WAGE RATES To determine the unit costs for typical new and existing respondents in each size category, the unit time estimates for compliance activities are multiplied by the hourly wage rates for the appropriate categories of labor conducting these activities. The labor wage rates for private industry are derived from the U. S. Department of Labor's Employment Cost Indexes and Levels. 12 The 2001 wage rates include wages and salaries; benefit costs, including paid leave, supplemental pay, insurance, retirement and savings, legally required benefits, severance pay, and supplemental unemployment benefits. EPA further adjusted these rates to reflect associated overhead costs. 13 These wage rates reflect private industry averages, which were estimated by the Bureau of Labor Statistics (BLS) based on a survey of 32,200 occupations within 7,500 establishments in the private sector. These wage rates reflect industry averages, which may underestimate the actual wages received by some SPCC regulated facility personnel but overestimate the actual wage rate received by other facility personnel. The estimated wage rates used in the analysis are: 38 Management: $48.95/ hour; Technical: $32.60/ hour; and Clerical: $20.69/ hour. Overhead rates can be calculated using various formulas. The reasons for using a 17 percent overhead rate are described above. To see how overall costs might change, we also calculated alternative overhead rates based on recommendations in Estimating Costs for the Economic Benefits of RCRA Noncompliance (September 1997). The guidance suggests that overhead rates should be calculated by adding 50 to 100 percent of the base salary and fringe benefit costs. We estimate that raising the overhead rate to 50 percent would increase the wages listed above by 28 percent. If a 100 percent overhead rate were used, these wages would increase by 71 percent. These alternatives may be high because the rates include profit as well as overhead. The alternative overhead rate is used to determine alternative total costs and savings and is found in the discussion of total respondent costs in Section 6( f) of the supporting statement to the Information Collection Request. 3. 3 UNIT COSTS The basis for each unit cost estimate is explained in this section. Unit costs estimates are calculated for revised provisions that are expected to affect the burden posed to a facility. Of these revised provisions, the vast majority are intended to reduce the overall burden to a regulated facility. Specifically, the changes to the rule that EPA expects to affect the burden of the SPCC program are: ° Final 40 CFR 112.1( d)( 2)( i) and 112.1( d)( 4). EPA is no longer regulating under the SPCC program a completely buried tank that is subject to all of the technical requirements of 40 CFR part 280 or of a State program approved under 40 CFR part 281. ° Final 40 CFR 112.1( d)( 2)( ii). EPA is no longer regulating a facility having a single container with a storage capacity greater than 660 gallons, but aggregate aboveground storage capacity of 1, 320 gallons or less of oil. ° Final 40 CFR 112.1( d)( 5). EPA is no longer regulating any container with a storage capacity of less than 55 gallons of oil. ° Final 40 CFR 112.1( d)( 6). EPA is no longer regulating wastewater treatment facilities or parts thereof (except at oil production, oil recovery, and oil recycling facilities) used exclusively for wastewater treatment and not used to meet any other requirement of part 112. 39 ° Final 40 CFR 112.1( f). EPA is granting its Regional Administrators the authority to require any facility subject to the jurisdiction of EPA under section 311( j) of the CWA, but otherwise exempt from the requirement to prepare an SPCC Plan under part 112, to prepare and implement a total or partial SPCC Plan where necessary to carry out the purposes of the CWA. ° Final 40 CFR 112.3( a). EPA is requiring an SPCC­ regulated facility to amend its SPCC Plan to conform with the new sequence and requirements of the final rule, if necessary, within six months of the effective date of the final rule and to implement the Plan within 12 months. ° Final 40 CFR 112.3( e)( 1). EPA is changing from eight hours to four hours the minimum number of hours that a facility must be attended for it to be required to maintain a copy of an SPCC Plan on the premises. ° Final 40 CFR 112.4( a). EPA is changing the threshold for submission of information following certain discharges and is reducing the amount of information that must be submitted to the Agency after such discharges. ° Final 40 CFR 112.5( b) and (c). EPA is changing the Plan review period from three to five years and is requiring the owner or operator of a facility to document the completion of the review and evaluation. A Professional Engineer's (PE) certification of a Plan amendment will now only be required for technical changes made to the Plan. ° Final 40 CFR 112.7. EPA is allowing an owner or operator to use an alternate format from that specified in the rule if the format is acceptable to the Regional Administrator, meets all applicable rule requirements or is supplemented so that it does, and is cross­ referenced to those requirements. ° Final 40 CFR 112.7( a)( 2). EPA is allowing a facility to deviate from most substantive requirements if the owner or operator explains his reasons for nonconformance and provides equivalent environmental protection. ° Final 40 CFR 112.7( a)( 3). EPA is requiring an SPCC­ regulated facility to include with its Plan a facility diagram, which must mark the location and contents of each container. ° Final 40 CFR 112.7( d). EPA is exempting the owner or operator of a facility which has submitted a Facility Response Plan (FRP) from the requirement to provide a contingency plan and a written commitment of manpower, equipment, and materials to expeditiously control and remove any quantity of discharged oil that may be harmful. 40 ° Final 40 CFR 112.7( e). EPA is allowing records of inspections and tests kept under usual and customary business practices to suffice for records of inspections and tests required under part 112. ° Final 40 CFR 112.7( i). EPA is requiring the owner or operator to evaluate a field­ constructed aboveground container for risk of discharge or failure due to brittle fracture or other catastrophe when the container undergoes a repair, alteration, or a change in service that might affect the risk of brittle fracture or other catastrophe. The effect that each of these changes is expected to have on burden and costs is discussed in greater detail below. In addition to these changes, EPA has also estimated the burden and costs that will be incurred by facilities to read and understand the final rule, which is discussed at the conclusion of this section. 3.3.1 40 CFR 112.1( d)( 2)( i) and 112.1( d)( 4) EPA has decided to no longer regulate, under the SPCC program, a completely buried tank that is also regulated under the UST program (40 CFR part 280 and or a State program approved under 40 CFR part 281). This decision decreases both the number of regulated facilities as well as the overall burden for some other facilities that will continue to be regulated under the SPCC program. In total, about 26,000 facilities will be affected by this change. EPA believes, based on Survey data, that a little over 14, 000 facilities will no longer be regulated under the SPCC program as a result of this change. These facilities represent those that are SPCC­ regulated because they have a completely buried storage capacity in excess of 42,000 gallons that is also regulated by the UST program. The remaining 12, 000 facilities, although they will continue to be regulated under the SPCC program due to their aboveground storage capacity, will experience a significant reduction in burden because their Plans will no longer have to include a discussion of their completely buried tanks. As a result, the burden reduction to some large facilities will make them more similar to a medium facility and some medium facilities will experience a burden reduction that will make them more like a small facility. The effect that this change is expected to have on the number and makeup of regulated facilities is discussed in greater detail in Section 3. 4. 1 of this document. 3.3.2 40 CFR 112.1( d)( 2)( ii) EPA is no longer regulating a facility under the SPCC program merely because it has a single container with an aboveground storage capacity of greater than 660 gallons of oil. Instead a facility must have an aggregate aboveground capacity of greater than 1,320 gallons to be regulated. 41 Analysis of the Survey data showed that about 10.5 percent of small facilities would no longer be regulated if this option was enacted. As a result, EPA expects that about 39,623 small facilities (39, 231 existing facilities and 392 new facilities) will no longer be regulated. Of this total, approximately 70 percent, or about 27,700 facilities are small farms. Other industries that are likely to experience a significant decrease in the number of regulated facilities include primary and secondary schools and colleges as well as gasoline service stations. The remaining number of facilities are evenly distributed among the manufacturing and transportation sectors of the economy. The effect that this change is expected to have on the number and makeup of regulated facilities is discussed in greater detail in Section 3. 4. 1 of this document. 3.3.3 40 CFR 112.1( d)( 5) EPA has also decided to no longer regulate a container having an oil storage capacity less than 55 gallons. The 55­ gallon container is the most widely used commercial bulk container, and is easily counted. Containers below 55 gallons in capacity are typically end­ use consumer containers. Fifty­ five gallon containers are also the lowest size bulk container that can be handled by a person. Containers above that size typically require equipment for movement and handling. EPA considered a minimum container size of one barrel. However, though a barrel or 42 gallons is a common volumetric measurement size for oil, it is not a common container size. Therefore, it would not be appropriate to institute a 42­ gallon minimum container size. Facilities are expected to benefit from this change in two ways. First, facilities will no longer have to include a discussion of these containers in their SPCC Plans and second, these containers will no longer count in determining a facility's total oil storage capacity. EPA believes that in the event of an oil spill, the amount of oil that would be spilled from containers of this size poses a minimal threat to the environment, which does not warrant the burden to facilities to discuss prevention, control, and countermeasure procedures in their SPCC Plans. As a result of this change, some facilities may no longer be regulated under the SPCC program. These facilities most likely are retail establishments that sell large quantities of oil in small containers (e. g., quarts of motor oil). While relatively few of these facilities were likely to be regulated under the SPCC program, EPA realized the potential that some could have been regulated due to their large volumes of inventory and thus has modified the rule to no longer regulate such facilities. Many other SPCC­ regulated facilities are also likely to benefit from this change as they no longer must include a discussion in their SPCC Plans on the procedures and equipment used to prevent the discharge of oil from small containers. This would primarily affect new facilities as existing facilities would have already incurred the burden to discuss these containers in their Plans. Existing facilities would benefit during their formal SPCC five­ year review as they no longer would have to update their 42 discussion of these containers. Because only a small number of facilities enter the SPCC program each year and because only a fraction of these facilities would expend a significant portion of their burden preparing an SPCC Plan to discuss small containers, EPA has chosen not to quantify the burden reduction associated with this rulemaking to avoid overestimating the effects. 3.3.4 40 CFR 112.1( d)( 6) Section 112.1( d)( 6) states that wastewater treatment facilities or parts thereof (except at oil production, oil recovery, and oil recycling facilities) used exclusively for wastewater treatment and not used to meet any other requirement of part 112 are exempted from part 112. Facilities or parts thereof used solely for the purpose of storing or using oil are not exempted, and their capacity must be counted as part of the storage capacity of the facility. Any oil storage capacity associated with or incidental to such facilities continues to be subject to part 112. At permitted wastewater treatment facilities, storage capacity includes bulk storage containers, hydraulic equipment associated with the wastewater treatment process, containers used to store oil which feed an emergency generator associated with wastewater treatment, and slop tanks or other containers used to store product resulting from wastewater treatment. EPA anticipates that section 112.1( d)( 6) will require certain facilities to recalculate their storage capacity to exclude wastewater treatment systems. As a result, some facilities may no longer meet the criteria for preparing an SPCC plan or FRP and, thus, may no longer be covered by the part 112 regulations. These facilities avoid the costs of an existing facility, but incur some costs in reading and understanding the exemption and in recalculating their storage capacity to determine if they qualify (see Exhibit 3­ 1). For other facilities that still meet SPCC/ FRP criteria after recalculating their storage capacity to exclude applicable treatment systems, they must amend their SPCC plan and FRP and have the plans certified by a Professional Engineer, pursuant to section 112.5. Exhibit 3­ 1 illustrates the expected burden and labor cost to facilities that meet the wastewater treatment exemption criteria and subsequently must modify their SPCC plan accordingly. Exhibit 3­ 1 Facility Unit Burden and Labor Cost Wastewater Treatment Exemption Matrix Type of Facility Burden Hours Unit Burden Hours Labor Cost Managerial Technical Clerical No Longer Meet Criteria 0.5 1. 3 0.0 1. 8 $65 43 Meet Criteria 0.0 4. 5 1.0 5. 5 $167 3.3.5 40 CFR 112.3( a) EPA is requiring an SPCC­ regulated facility to amend its SPCC Plan to conform with the new sequence and requirements of the rule within six months of the effective date of the final rule and another six months to implement any amendments made to the Plan. EPA had originally proposed to allow facilities 60 days from the date of the final rule to maintain and prepare a fully implemented SPCC Plan, but was persuaded by commenters to extend this period. Because the format and sequence of the rule has changed substantially and because many facilities will find that their existing SPCC Plan no longer follows the new sequence of the rule, EPA is providing a cross­ reference template for facilities. This template is found in the preamble to the rule and lists each requirement in the final rule, provides the corresponding paragraph of the previous rule, and leaves a space where a facility can display the location of the provision in its Plan. While some facilities may need to make minor amendments to their Plan as a result of the final rule, the majority of facilities most likely will not need to make any significant revisions beyond preparing the cross­ referencing matrix as it is assumed that these facilities already have SPCC Plans in good standing. New facilities are not expected to incur this burden as it is expected that they will prepare their Plans in accordance with the new sequence of the rule. Exhibit 3­ 2 summarizes the estimated burden likely to be incurred by each type of model facility to complete the cross­ reference matrix and append it to their existing SPCC Plan. The exhibit shows that it will require approximately one­ half hour of a technical person's time to complete the matrix and attach it to his facility's Plan. The burden associated with this activity is not expected to vary significantly among different types of model facilities because this activity is more closely related to the sequence of the new rule and format of the existing Plan and not to the total storage capacity of a facility. 44 Exhibit 3­ 2 Facility Unit Burden and Cost Cross­ Reference Matrix Type of Facility Burden Hours Unit Burden Hours Labor Cost Managerial Technical Clerical Small 0.0 0. 5 0.0 0. 5 $16 Medium 0.0 0. 5 0.0 0. 5 $16 Large 0.0 0. 5 0.0 0. 5 $16 EPA understands that some facilities may elect to reorganize their Plans to follow the new sequence of the rule. However, EPA believes that most of these facilities would only elect to undergo this additional burden if other significant amendments need to be made to the Plan. Such an activity would likely occur during a formal review period of the Plan, in which case, the burden associated with reorganizing the Plan would be incidental to the baseline burden associated with making amendments. 3.3.6 40 CFR 112.3( e)( 1) EPA has changed from eight hours to four hours the minimum number of hours that a facility must be attended for it to be required to maintain a copy of an SPCC Plan on the premises. In the event that a facility is manned less than four hours a day, the Plan must be kept at the nearest field office. EPA has made this change because the Agency believes that it is important to have a copy of the Plan located at the facility in the event of an oil discharge and because a small number of facilities mistakenly believed that they did not need to keep a copy of the SPCC Plan at the facility if the facility was manned by an individual working seven and one­ half hours at the facility with an additional one­ half hour for lunch. While EPA has amended the rule to clarify that a copy of the Plan must be kept at a facility unless it is principally unmanned during the day, this amendment will have relatively little effect on the overall burden of the SPCC program because the Plan previously must have been kept and maintained at the nearest field office if not at the facility. 3.3.7 40 CFR 112.4( a) EPA is reducing the information that a facility owner or operator must submit to the Agency after certain discharges as well as raising the threshold for the size of discharges that trigger submission under §112.4( a). To begin, EPA had required that an owner or operator of a facility subject to the SPCC rule provide certain information to 45 EPA after a discharge of 1,000 gallons of oil into or upon the navigable waters of the United States or adjoining shorelines in a single event, or when two reportable spills occur within any twelve month period. Reportable discharges are defined at 40 CFR 110.3. The information EPA required includes: ° The name of the facility; ° Name( s) of the owner or operator of the facility; ° Location of the facility; ° Date and year of initial facility operations; ° Maximum storage or handling capacity of the facility and normal daily throughput; ° Description of the facility, including maps, flow diagrams, and topographic maps; ° A complete copy of the SPCC Plan with any amendments; ° The cause( s) of such spill, including a failure analysis of system or subsystem in which the failure occurred; ° The corrective actions and/ or countermeasures taken, including an adequate description of equipment repairs and/ or replacements; ° Additional preventive measures taken or contemplated to minimize the possibility of recurrence; and ° Such other information as the Regional Administrator may reasonably require pertinent to the Plan or spill event. EPA is revising this list of information, to be provided to the RA in the event of a reportable discharge under §112.4( a), to no longer include a complete copy of the SPCC Plan in the report. Furthermore, EPA has clarified in the final rule that a facility must only include maps, flow diagrams, and topographic maps as necessary to describe the facility and discharge. In some instances, a facility may still need to submit this information if the RA deems it appropriate. EPA is also raising the threshold for the size of discharges that trigger submission under the final rule. First, EPA is establishing a de minimis spill volume of 42 U. S. gallons for a facility to use in determining whether or not a discharge reportable to the National Response Center under 40 CFR part 110 counts towards one of the two discharges under 1,000 gallons also reportable to EPA. EPA is also clarifying in the final rule that facilities are subject to a "rolling basis" for purposes of tracking discharges under §112.4( a). Under a rolling basis, each reportable discharge under §112.4( a) triggers the start of a new twelve month reporting period. While EPA believes that these changes to the rule will cause many facilities that experience discharges to incur less of a reporting and recordkeeping burden, the remote possibility that any one particular facility would experience either a 1, 000 gallon discharge or two reportable discharges under §112.4( a) within a twelve month period is 14 The rule suggests the facility owner or operator use following statement to fulfill the requirement: "I have completed review and evaluation of the SPCC Plan for (name of facility) on (date) and will (will not) amend the Plan as a result." 46 so small that the cumulative information burden that would be reduced by these changes for the entire regulated universe of facilities is negligible. 3.3.8 40 CFR 112.5( b) and (c) EPA has extended the period in which an owner or operator must review and evaluate a facility's SPCC Plan from three to five years. EPA is making this change because it believes that an extension of the review period will reduce the information collection burden, while causing little or no increased risk to the environment. EPA is also requiring a facility owner or operator to document when a review of the Plan has been completed and to state whether the Plan was amended as a result of the review. This requirement, however, does not add to the burden of the SPCC program as defined by the Paperwork Reduction Act because it falls outside the definition of information found at 5 CFR part 1320. 14 In any event, the requirement represents a negligible increase to the time needed to review the Plan. EPA has also amended the SPCC rule under 40 CFR 112.5( c) to provide that a Professional Engineer need only certify technical amendments made to the SPCC Plan. This also is expected to result in a minor burden reduction for facilities as the rule previously stated that any amendment needed to be certified by a PE. However, EPA believes, for purposes of this analysis, that the effect of this change on the cumulative burden of the program will be minimal and therefore did not quantify this effect to avoid overstating burden reduction. The overall effect of expanding the review period from once every three years to once every five years is expected to reduce the annual unit burden associated with the review process by 0. 6 hours for an average small facility, 0. 9 hours for a medium facility, and 1. 3 hours for a large facility. These estimates were derived by dividing the estimated unit burden associated with performing a review by five, rather than three, to estimate the average annual burden per facility. EPA notes that no facility owner or operator will have to perform the five­ year review in the first two years following the implementation of this rulemaking. This results from the fact that all existing facilities are assumed to have performed a review within the past three years to comply with the previous requirements of this rule. Exhibit 3­ 3 presents the estimated burden reduction for an average small, medium, and large facility to complete this activity in the first and second years following the rulemaking as well as in subsequent years. 47 EXHIBIT 3­ 3 Estimated Reduction in Unit Burden Hours and Unit Costs Five­ Year Review Average Facility (First and Second Years / Subsequent Years) Type of Facility Annual Burden Hours Unit Burden Hours O& M Costs Unit Cost Managerial Technical Clerical Small (0. 3) / (0. 1) (1.0) / (0.4) (0. 2) / (0. 1) (1.5) / (0.6) ($ 5) / ($ 3) ($ 57) / ($ 23) Medium (0. 3) / (0. 1) (1.6) / (0.7) (0. 3) / (0. 1) (2.3) / (0.9) ($ 3) / ($ 2) ($ 79) / ($ 32) Large (0. 3) / (0. 1) (2.7) / (1.1) (0. 3) / (0. 1) (3.4) / (1.3) ($ 2) / ($ 1) ($ 113) / ($ 45) 3.3.9 40 CFR 112.7 EPA has amended the definition of an acceptable SPCC Plan to include a plan that deviates from the sequence of the rule. Such plans may include State plans, Integrated Contingency Plans, and any other formats acceptable to the Regional Administrator. When such plans are substituted for a formal SPCC Plan (i. e., one that follows the sequence of the rule) it must include a cross­ reference to identify the provisions of the plan to the requirements listed in the SPCC rule. All of the requirements in the SPCC rule must be addressed. If they are not all addressed in the equivalent plan, then the plan must be supplemented to include unaddressed requirements. To develop burden reduction estimates associated with allowing the use of a plan prepared to meet State requirements, EPA conducted an analysis that compared State regulations to SPCC requirements at 40 CFR part 112. The analysis revealed that 19 States had prevention planning requirements pursuant to State law. In certain cases, State law closely tracks or incorporates by reference Federal SPCC requirements. In other cases, the degree of overlap is less complete but is still substantial. Based on a careful comparison of State regulations with a list of major SPCC planning requirements, EPA divided the 19 States into three overlap groups (complete, substantial, or partial), depending on the degree of overlap between the Federal and State requirements. Another factor that EPA considered is that many State prevention planning regulations apply to a smaller universe of facilities than is regulated by the SPCC program. Using data on oil production wells, farms, and U. S. Census establishments in each State, the Agency estimated the fraction of Federal SPCC­ regulated facilities nationwide that were in each overlap group. The analysis took into account specific limits and exemptions in State programs when estimating the size of the regulated 15 To incorporate the overlap between State and Federal requirements into this analysis, the unit burden estimates were revised downwards to account for the overlap. Additional changes to the estimates were then incorporated to create unit burden estimates averaged for all regulated facilities and to eliminate the possibility of double­ counting benefits or costs. These average estimates were then multiplied by the universe of regulated facilities to obtain total industry costs. 48 community. The Agency made separate estimates for production and storage facilities in the small, medium, and large categories. These estimates are presented in Exhibit 3­ 4. Overall, 5. 9 percent of facilities are regulated by both EPA and the State in the group of States with complete overlap (an estimated six States), about 5.6 percent in the group with substantial overlap (an estimated six States), and about 5.7 percent in the group with partial overlap (an estimated seven States). EXHIBIT 3­ 4 Estimated Number and Percentage of Existing Facilities With Overlap Between Federal and State Requirements (First Year) Small Medium Large Total Complete Overlap 4.4% 11.2% 15.1% 5.9% Substantial Overlap 4.1% 10.4% 14.4% 5.6% Partial Overlap 4.1% 10.5% 15.1% 5.7% Total 12.7% 32.1% 44.6% 17.2% Finally, to develop the estimates of reduced regulatory burden, EPA multiplied the baseline hours burden by both the percentage of facilities in each overlap category and the degree of overlap (i. e., 100 percent for complete overlap, 75 percent for substantial overlap, and 50 percent for partial overlap). EPA recognizes that the burden reduction is offset somewhat by the need to develop a cross­ reference and adjusted its estimate of burden reduction appropriately. Thus, the burden after the regulatory change reflects both the number of regulated facilities in the affected States and the amount of similarity between the State and Federal regulatory requirements. Exhibit 3­ 5 shows the total number of burden reduction hours that EPA expects to realize as part of this expansion of the definition of an acceptable SPCC Plan. 15 49 EXHIBIT 3­ 5 Total Number of Hours Estimated to be Spent by SPCC­ Regulated Facilities Complying with Similar State Requirements (First Year) Small Medium Large Total Existing Facilities 174,401 144,894 58,626 377,922 New Facilities 14,020 12,130 4,281 30,431 Total 188,422 157,024 68,908 408,354 These estimates represent approximations in order to account for the burden reduction that might result from this regulatory action. EPA recognizes that other States are in the process of developing prevention planning rules and the Agency will revise estimates at a future point in time to account for such new developments. In addition, the Agency notes that the ultimate determination of whether a plan prepared pursuant to State regulations is acceptable as an SPCC Plan will be made by EPA Plan reviewers on a case­ by­ case basis. On average, EPA believes that the estimate provided as part of this analysis is a reasonable indicator of the degree of burden reduction that is afforded by this added flexibility. The Agency intends to develop guidance for Regional personnel to facilitate the review of plans prepared pursuant to State regulations and promote the use and acceptance of alternate formats. It is important to note that the definition of "SPCC Plan" to include State "SPCC" plans would not reduce the actual universe of regulated facilities. Facilities with such State plans would not be exempt from the regulation; however, because the information collection burden associated with preparing these plans would be imposed regardless of Federal requirements, it has not been included as part of this EA. 3.3.10 40 CFR 112.7( a)( 2) EPA is allowing a deviation from most of the rule's substantive requirements provided that equivalent environmental protection is provided and that the Plan contains a reason for nonconformance with the requirement( s). This revision explicitly allows deviations for SPCC requirements other than just secondary containment, which most likely will decrease the capital­ related costs for some facilities. This revision arguably provides the greatest flexibility for facilities in complying with the requirements of this rule. The paperwork burden remains the same because the owner or operator now has the same flexibility in the current rule for the application of good engineering practice. 3.3.11 40 CFR 112.7( a)( 3) 50 EPA has added a new requirement requiring a facility owner or operator to describe the physical layout of the facility and to include a facility diagram in the Plan. This facility diagram must include the location and contents of all containers above the de minimis container size, including completely buried tanks that are exempt from other SPCC requirements. The diagram must also include all facility transfer stations and connecting pipes. EPA is requiring this information because it is used for effective prevention, planning, management (e. g., inspections), and response considerations. It is also necessary for all facilities, large or small, because container­ specific information helps an inspector to verify whether a Plan is needed (by evaluating whether the product stored is oil); to verify capacity calculations; and to formulate contingency planning calculations if such planning is necessary. Although there is no specific counterpart in the previous version of the rule, the previous version has required a facility owner or operator to include in his Plan a prediction of the direction, rate of flow, and total quantity of oil, which could be discharged from the facility as a result of each major type of failure (40 CFR part 112.7( b)). To comply with this requirement, many facilities have needed to prepare facility diagrams. The rule has also required a facility to conduct periodic integrity testing of aboveground storage tanks (40 CFR part 112.7( e)( 2)( D)), which would require a facility diagram to assist inspectors in locating such tanks. EPA has observed, based on facility inspections, that many facilities have already prepared and use such diagrams. This is especially true for the larger and more complex facilities. For these facilities, it would entail minimal burden to formally incorporate an existing facility diagram into their Plan. EPA believes that it will require such a facility only about 15 minutes of clerical time to include a previously prepared diagram in their SPCC Plan. This estimate is based on the time required to either copy the diagram or print out an electronic copy and place it in the Plan and update the table of contents. EPA is aware, however, that many facilities, especially smaller facilities, most likely have not prepared such diagrams as part of their normal business operations. As a result, EPA has calculated the burden for facilities to prepare these diagrams and include them in their SPCC Plans. For a small model facility having two containers, EPA estimates that it will require approximately one hour of technical time and one­ half hour of clerical time to mark the location and contents of the containers at the facility including the facility's transfer stations and connecting pipes. EPA estimates that approximately 25 percent of the total number of small facilities have already prepared facility diagrams, so only 75 percent of the small facilities would incur this burden. 51 For a medium model facility, having seven containers, EPA estimates that it will require approximately two hours of technical time and one­ half hour of clerical time to develop such a diagram. EPA estimates that about one­ half of the medium facilities have already prepared diagrams and only need to place a copy of the diagram in the SPCC Plan. For large facilities, EPA believes that it is most likely that all of these facilities have previously prepared diagrams. As a result, large facilities, in addition to small and medium facilities that have already prepared a diagram, will require only about 15 minutes of clerical time to include the diagram in their SPCC Plan. Exhibit 3­ 6 summarizes EPA's weighted average estimate of the burden likely to be incurred by facilities to prepare this information based on the percentages of facilities in each category likely to have previously prepared facility diagrams. EXHIBIT 3­ 5 Estimated Weighted Burden Associated with Preparing Facility Diagrams Type of Facility Annual Burden Hours Unit Burden Hours Unit Cost Managerial Technical Clerical Small 0.0 0. 8 0.4 1. 2 $34 Medium 0.0 1. 0 0.3 1. 4 $39 Large 0.0 0. 0 0.25 0.25 $6 3.3.12 40 CFR 112.7( d) EPA has revised this section to require a facility that has determined it is not practicable to install the structures or equipment listed in §§ 112.7( c), 112.8( c)( 2), 112.9( c)( 2), 112.10( c), 112.12( c)( 2), 112.12( c)( 11), 112.13( c)( 2), and 112.14( c) to conduct periodic integrity testing of the affected containers, and periodic integrity and leak testing of valves and piping. While the previous section of this rule did not explicitly require facilities to conduct periodic integrity testing of equipment affected by part 112, EPA has defined periodic integrity testing to mean in accordance with industry standards (e. g., API 653). As a result, EPA does not believe that this additional language constitutes an additional recordkeeping burden on facilities as it is merely codifying usual and customary business practices. EPA is exempting the owner or operator of a facility which has submitted a Facility Response Plan (FRP) from the requirement to provide a contingency plan and a written commitment of manpower, equipment, and materials to expeditiously control and remove any quantity of discharged oil that may be harmful. EPA believes that this exemption will result in negligible cost savings to facilities due to both the low number of FRP facilities and the minor unit cost savings. 52 3.3.13 40 CR 112.7( e) EPA has revised the rule to explicitly allow the use of records of inspections and tests kept pursuant to usual and customary business practices to suffice for records of inspections and tests that must be performed and maintained in accordance with written procedures developed for the facility. The rule also allows for these records to be kept separately from the SPCC Plan. EPA believes that these revisions will eliminate a facility's practice of keeping duplicate records for purposes of the SPCC rule. Examples of records of inspections and tests may include records of stormwater bypass events that are required pursuant to 40 CFR part 122. Part 122 contains the National Pollution Discharge Elimination System (NPDES) program rules, promulgated pursuant to Clean Water Act authority. Among other requirements, the NPDES rules require documentation of a discharge of rainwater from a diked area into a storm drain or an effluent discharge that empties into an open water course, lake, or pond, and bypasses the in­ plant treatment system. The NPDES rules serve the same objective as the SPCC requirement formerly at §112.7( e)( 2)( iii)( D), and would therefore be acceptable to satisfy the SPCC requirement. This is now explicitly stated in the final rule under §112.8( c)( 3). At facilities where an owner or operator maintained the NPDES records in lieu of records maintained specifically for purposes of the SPCC rule, therefore, the information collection burden would be attributable to the NPDES program, and not to part 112. EPA has issued general permits for stormwater discharges covered by the NPDES stormwater program in 1992 (baseline general permit) and in 1995 (multisector general permit), see 57 FR 44446 (September 25, 1992) and 60 FR 51215 (September 29, 1995). The Agency estimated that about 100,000 facilities nationwide discharge stormwater associated with industrial activity, not including oil and gas exploration and production operations, and many of these facilities are in industrial categories (such as mining, manufacturing, and transportation) that include SPCC­ regulated facilities. U. S. Census data indicate that there are slightly more than 500,000 facilities in these industrial categories, so this analysis assumes that about 20 percent of industrial facilities are subject to the NPDES stormwater permits. There are approximately 58,000 SPCC­ regulated facilities in the industrial categories that are also regulated under the NPDES program, so about 12,000 of these facilities (about 20 percent) are assumed to be subject to the permits. For purposes of the burden reduction analysis, these 12,000 facilities are assumed to be medium and large oil storage facilities and represent approximately 22 percent of the baseline 16 EPA is assuming, for the purposes of this analysis, that it is unlikely that a significant number of small facilities would also be subject to the NPDES program because of the low number of small industrial facilities and the increased likelihood that these facilities are connected to a municipal wastewater service. 53 estimate of medium and large oil storage facilities. 16 Although EPA has not estimated the number of oil production facilities subject to NPDES, this analysis assumes that 22 percent of the medium and large production facilities are also subject to the permits and would similarly have a reduced recordkeeping burden. EPA estimates that each facility subject to the NPDES regulations would experience approximately one hour of technical recordkeeping reduction as a result of complying with the NPDES standards. However, because not all SPCC­ regulated facilities experience this reduced recordkeeping burden, the estimate must be weighted to reflect the decrease that would occur, on average, at all facilities. The corresponding weighted decrease in unit burden for both an average medium facility and an average large facility is therefore estimated to be about 0.2 technical hours. Exhibit 3­ 7 shows the estimated burden reduction associated with this proposed change for an average small, medium, and large facility, respectively. EXHIBIT 3­ 7 Estimated Weighted Reduction in Unit Burden Hours and Unit Costs NPDES Average Facility Type of Facility Annual Burden Hours Unit Burden Hours Unit Cost Managerial Technical Clerical Small 0.0 0. 0 0.0 0. 0 $0 Medium 0.0 (0.2) 0.0 (0.2) ($ 7) Large 0.0 (0.2) 0.0 (0.2) ($ 7) Another example of usual and customary business records are records of inspections and tests kept by a facility following standard industrial practices, such as the American Petroleum Institute's (API) Standards 653 and 2610. EPA believes that these standards represent usual and customary business practices for certain facilities in the petroleum industry and that the burden associated with developing and maintaining such records should no longer be attributed to the SPCC burden. Specifically, §112.8( c)( 6) requires periodic integrity testing of an aboveground container's shell, tank supports, and foundations taking into account tank design (floating roof, etc.) using a non­ destructive shell testing technique combined with a visual inspection. An owner or operator is required to keep comparison records of these events for a period of at least three years. 54 However, this requirement is similar to the recommended practices suggested in the following two industry standards:
API 653 ­­ Tank Inspection, Repair, Alteration and Reconstruction. API 653 is considered the predominant standard for tank inspection and its provisions are based on the tank design principles found in API 620 and 650. API 653 calls for owners or operators of tanks and associated systems to maintain a complete record file consisting of construction, repair/ alteration history, and inspection history records. Inspection history includes all measurements taken, the condition of all parts inspected, and a record of all examinations and tests.
API 2610 ­­ Design, Construction, Operation, Maintenance, and Inspection of Terminal and Tank Facilities. API 2610 incorporates the requirements of many different standards for tanks into one document. The standard recommends that periodic inspection and preventive maintenance be conducted on all transfer systems to control leaks and that complete maintenance records should be maintained by the operator for all equipment within a terminal. To estimate the reduction in SPCC recordkeeping burden as a result of the overlap with these industry standards, EPA assumed that all production facilities and the following types of petroleum­ industry storage facilities comply with API standards:
Bulk stations and terminals;
Gasoline service stations;
Fuel oil dealers; and
Petroleum refiners. The estimated reduction in recordkeeping burden for such facilities varies according to the size and type of the facility. Exhibit 3­ 8 presents the reduction in the recordkeeping unit burden estimate by facility type for facilities that follow industry guidelines that are similar to certain SPCC recordkeeping provisions. Only technical recordkeeping time is assumed to be affected by the rule change. 17 1997 Proposed Rule ICR (EPA #0328.06, 10/ 20/ 97) 55 EXHIBIT 3­ 8 Estimated Reduction in Unit Recordkeeping Burden for API Complying Facilities Type of Facility Reduction in Technical Burden Hours Small (1. 0) Storage Medium (3. 0) Large (7. 5) Small (1. 5) Production Medium (1. 5) Large (1. 5) Again, because not all SPCC­ regulated facilities follow the industry standards discussed previously, the burden reduction estimates must be weighted to reflect the decrease that would occur, on average, at all facilities. Approximately 136,400 small facilities (36 percent of all small facilities), 41, 600 medium facilities (51 percent of all medium facilities), and 2, 900 large facilities (23 percent of all large facilities) are expected to be affected by the rule change. 17 The weighted unit burden reduction is therefore calculated to be 0. 0 to 1.5 hours for an average small facility, 1. 0 to 1. 5 hours for an average medium facility, and 1. 4 to 1. 5 hours for an average large facility. Exhibit 3­ 9 presents the estimated weighted burden reduction for an average small, medium, and large storage and production facility, respectively. 56 EXHIBIT 3­ 9 Estimated Weighted Reduction in Unit Burden Hours and Unit Costs API Standards Average Facility Annual Burden Hours Unit Burden Hours Unit Cost Type of Facility Managerial Technical Clerical Small 0.0 0. 0 0.0 0. 0 $0 Storage Medium 0.0 (1.0) 0.0 (1.0) ($ 33) Large 0.0 (1.4) 0.0 (1.4) ($ 46) Small 0.0 (1.5) 0.0 (1.5) ($ 49) Production Medium 0.0 (1.5) 0.0 (1.5) ($ 49) Large 0.0 (1.5) 0.0 (1.5) ($ 49) 3.3.14 40 CFR 112.7( i) EPA is requiring the owner or operator of a regulated facility to evaluate a fieldconstructed container's potential for brittle fracture or other catastrophe whenever the facility conducts major repairs or alterations to its tanks or modifies the service of its tanks. Field­ constructed storage containers are typically larger than 20,000 gallons, and, therefore, no small facilities are expected to evaluate their containers. Based on the expert judgment of engineers knowledgeable of SPCC­ regulated facilities, it is estimated that five percent of all medium and large storage facilities will be required to evaluate their containers each year (2, 801 medium and 586 large facilities). It is estimated that medium and large storage facilities that test their containers for brittle fracture will require four and twelve hours, respectively, to document records of tests and inspections. This recordkeeping burden is estimated to require an equal amount of technical and clerical time (see Exhibit 3­ 10). 57 EXHIBIT 3­ 10 Unit Burden Brittle Fracture Testing Recordkeeping Requirements * Annual Burden Hours Unit Burden Hours Unit Cost Type of Facility Managerial Technical Clerical Small 0.0 0. 0 0.0 0. 0 $0 Storage Medium 0.0 0. 1 0.1 0. 1 $3 Large 0.0 0. 3 0.3 0. 6 $15 Small 0.0 0. 0 0.0 0. 0 $0 Production Medium 0.0 0. 0 0.0 0. 0 $0 Large 0.0 0. 0 0.0 0. 0 $0 * The numbers in this exhibit may not add precisely due to rounding. 3.3.15 Reviewing and Understanding the Final Rule In addition to the burden incurred by a facility related to the above changes in the rule, all SPCC­ regulated facilities are expected to incur an additional burden associated with the time required to read and understand the revisions being made to the SPCC rule (see Exhibit 3­ 11). Based on a review of other information collection requests for rules of a similar magnitude, EPA estimates that it will require approximately 3. 5 hours per facility to review the final rule and to become familiar with the major changes being made in addition to the revised sequence of the rule. To ease this burden, EPA has published in the preamble to the final rule, a matrix identifying the major changes to the rule. The matrix describes, in plain English, the previous requirements of the rule, what is being revised, and any additional comments clarifying EPA's intentions. This burden is estimated to affect only existing facilities as they will need to be aware of the changes being made. The burden incurred by new facilities to read and understand the rule is already incorporated into the baseline burden associated with preparing a new Plan. Although the preamble to the final rule is lengthy, the vast majority of facilities will be affected by very few substantive changes. With the inclusion of the summary matrix in the preamble, it is not necessary for everyone to read the entire rule. The owner or operator of a small facility with an SPCC Plan can determine by reading the first few pages of the Federal Register notice that either the rule no longer applies to the facility, the owner or operator must prepare a facility diagram (if the Plan does not already have one) and a cross­ reference table (to ensure that each applicable provision of the revised rule is addressed in the Plan), Plan review is required less frequently, and records kept under usual and customary business practices will suffice 18 EPA examined ICR #820.07, Hazardous Waste Generator Standards, ICR #801.12, Hazardous Waste Manifest, and ICR #261.13, Hazardous Waste Notification. 19 U. S. Environmental Protection Agency, Analysis of the Number of Facilities Regulated by EPA's SPCC Program, 1996. 58 for SPCC recordkeeping. Reading the matrix of major changes near the beginning of the preamble will take owners and operators of most facilities much less than 3. 5 hours. For comparison, EPA examined other information collection requests with large numbers of affected facilities. 18 EPA believes that the burden for reading and understanding those regulations is similar to the SPCC­ rule burden because the regulations are similar in length to the revisions to the rule that SPCC­ regulated facilities will have to read. EPA found that the burden per respondent to review and understand the rule in each of these ICRs was lower than 3.5 hours. EXHIBIT 3­ 11 Burden Associated with Reviewing and Understanding the Final Rule Type of Facility Annual Burden Hours Unit Burden Hours Unit Cost Managerial Technical Clerical Small 1.0 2. 5 0.0 3. 5 $130 Medium 1.0 2. 5 0.0 3. 5 $130 Large 1.0 2. 5 0.0 3. 5 $130 3. 4 ESTIMATED NUMBER OF REGULATED FACILITIES This section describes the universe of facilities subject to the SPCC regulation. To determine the scope of production facilities and storage facilities in most industrial categories, the baseline number of facilities was determined in the 1995 SPCC Survey. As described in the analysis titled "Analysis of the Number of Facilities Regulated by EPA's SPCC Program," however, a few industry categories were not sampled or had a response rate too low to allow for extrapolation. 19 For those industry categories, estimates of the number of facilities from the 1991 SPCC Facilities Study were used to supplement the Survey totals. For a few other industry categories, the Survey analysis was thought to underestimate the national number of SPCC facilities, while the Facilities Study was thought to overestimate these facilities. In these cases, the midpoint of Survey and 20 Use of this estimate may lead to a slight overestimate in the number of facilities subject to paperwork requirements under the Paperwork Reduction Act because it includes a small number of Federal facilities, which are not defined as "persons" under OMB's final rule on reporting and recordkeeping requirements (60 FR 44978). 21 U. S. Department of Commerce, County Business Patterns (annual editions for years 1976­ 1986), 1978­ 1988. 22 Facilities ceasing operations were primarily small facilities from the farming and oil production sectors of the SPCC­ regulated universe. For farms, the average annual decrease in the number of farms from 1983 to 1992 was approximately 1.4 percent of the total number of farms (Statistical Abstract of the United States, 1993). For production facilities, the number of stripper wells decreased by 2. 1 percent from 1992 to 1993 (1994 API Oil Data Book). This analysis assumes that these overall rates of decrease apply proportionately to those facilities within these sectors that are SPCC­ regulated. Because small farms and production facilities represent approximately 60 percent of all SPCC­ regulated facilities, EPA anticipates 59 Facilities Study estimates for these industry categories was selected for use in calculating an adjusted national estimate. Adjustments to the estimate were also made to reflect that the survey design limited sampling to the 48 contiguous States. Following this adjustment and validation process, EPA arrived at an adjusted national estimate of the number of facilities subject to the SPCC regulation for each industry category. An estimated 437,700 facilities in total were regulated by the SPCC Program in 1995. 20 Additionally, EPA assumes the annual number of new SPCC facilities equals one percent of the number of existing facilities. The estimate of the total number of existing and new facilities was inflated by a one percent annual growth rate to yield an estimated 473,966 facilities subject to the SPCC regulation prior to these revisions. This estimate is composed of a total of 469,274 existing facilities for the first year following the regulation's implementation. The breakdown by facility size was estimated to be 372,286 small facilities, 87, 495 medium facilities, and 14, 185 large facilities. The one percent annual growth rate is assumed to continue for the duration of the rule's existence. To develop the one percent annual growth rate figure, U. S. Census data on the number of manufacturing establishments were reviewed. 21 These data indicate that the number of manufacturing establishments in the U. S. increased by an average of 1.4 percent annually over the 10­ year period from 1976­ 1986. This number pertains to the net annual increase in the number of establishments (new establishments less establishments closed). However, an estimate of the annual number of new establishments (without closings subtracted out) is needed. Therefore, based on professional judgment, the 1.4­ percent figure was adjusted upward to 2 percent to better reflect the addition of new facilities (and the resumption of operations at facilities that had been closed). This growth trend, however, is offset to some extent by recent declines in the number of farms and production facilities, which represent a large percentage of all SPCC­ regulated facilities. 22 that these losses partially offset the overall projected growth in the SPCC universe. 60 Analysis of data from the 1995 SPCC Survey, showed that a decrease in the total number of farms does not necessarily mean that the number of SPCC­ regulated farms is decreasing. This is true because the average acreage per farm is increasing, so that much of the decrease in the number of farms probably comes from small farms that did not have sufficient oil storage capacity to be subject to the SPCC regulation. It is assumed that roughly one­ half of the regulated facilities are in categories such as farms that showed no growth and the other half are in categories like manufacturing establishments that had a 2 percent growth, therefore the overall growth rate for all facilities is about 1 percent. The SPCC­ regulated community is very diverse, and different categories of facilities will have different growth rates from year to year, so the 1 percent rate represents only a rough approximation. Other broad data, however, support a growth rate of approximately 1 percent. For example, the 1999 Annual Energy Outlook from DOE's Energy Information Administration shows that consumption of petroleum products increased from 36.03 quadrillion Btus in 1996 to 36.49 quadrillion Btus in 1997. Exhibit 3­ 12 illustrates the estimated baseline number of existing and new SPCC facilities. EXHIBIT 3­ 12 Baseline Number of Existing and New Facilities (First Year) Small Medium Large Total Storage 240,802 60,040 13,723 314,565 Existing Production 127,799 26,589 322 164,709 Total 168,600 86,629 14,045 469,274 Storage 2,408 600 137 3,146 New Production 1,278 266 3 1, 547 Total 3,686 866 140 4,693 Total 372,286 87,495 14,185 473,966 * The numbers in this exhibit may not add precisely due to rounding. 3.4.1 Adjusting Universe Estimates 23 U. S. Environmental Protection Agency, Analysis of the Number of Facilities Regulated by EPA's SPCC Program, 1996. 61 Several of the revisions being made to the SPCC program will affect the number of facilities currently regulated under the program. For the purposes of this EA, EPA has quantified the effects of the four major revisions that will affect the number of SPCC­ regulated facilities. These revisions are:
Final 40 CFR 112.1( d)( 6). EPA is no longer regulating wastewater treatment facilities or parts thereof (except at oil production, oil recovery, and oil recycling facilities) used exclusively for wastewater treatment and not used to meet any other requirement of part 112. ° Final 40 CFR 112.1( d)( 2)( i) and 112.1( d)( 4). EPA is no longer regulating under the SPCC program a completely buried tank that is subject to all of the technical requirements of 40 CFR part 280 or of a State program approved under 40 CFR part 281. ° Final 40 CFR 112.1( d)( 2)( ii). EPA is no longer regulating a facility having a single container with a storage capacity greater than 660 gallons, but aggregate aboveground storage capacity of 1, 320 gallons or less of oil. ° Final 40 CFR 112.1( f). EPA is granting its Regional Administrators the authority to require any facility subject to the jurisdiction of EPA under section 311( j) of the CWA, but otherwise exempt from the requirement to prepare an SPCC Plan under part 112, to prepare and implement a total or partial SPCC Plan where necessary to carry out the purposes of the CWA. The effects that the above changes will have on the number of SPCC­ regulated entities is discussed in greater detail below. Final 40 CFR 112.1( d)( 6). EPA estimates that there are approximately 469,274 existing SPCC facilities. Of these, 154,709 facilities (33 percent) involve operations and oil storage activities exclusively limited to oil production. Such facilities are specifically excluded from the exemption under section 112.1( d)( 6). According to the 1995 SPCC Survey 23 , approximately 10 percent of all existing SPCC oil storage facilities are associated with the petroleum industry (e. g., gasoline stations, bulk stations, bulk terminals, pipelines, and heating oil distributors). If EPA assumes that these storage facilities are unlikely to have wastewater treatment systems covered by the exemption, then 10 percent of the 314,565 storage facilities, or 31, 457 24 EPA assumes that 10 percent of storage facilities from each size category will be associated with the petroleum industry. Insufficient data are available to determine whether there are differences among the categories. 25 All of the farms were subtracted from the small facility category, consistent with results of the 1995 SPCC Survey (Environmental Protection Agency, Analysis of the Number of Facilities Regulated by EPA's SPCC Program, 1996), which determined that all SPCC­ related farm storage of oil occurs at small facilities. 62 facilities, would not be affected by section 112.1( d)( 6) due to their focus on petroleum products. 24 Storage facilities also include 174,972 farms, or 56 percent of all storage facilities. For this analysis, EPA assumes that farms are unlikely to have wastewater treatment systems covered by section 112.1( d)( 6). Subtracting oil production, petroleum industry, and farm facilities from the universe of SPCC facilities leaves 108,136 facilities potentially affected by section 112.5( d)( 6). These remaining facilities are associated with the following industries identified in Exhibit 1: ° Coal mining, non­ metallic mineral mining and quarrying; ° Electric power generation, transmission, and distribution; ° Heavy construction; ° Other manufacturing; ° Transportation (excluding pipelines), warehousing, and marinas; ° Elementary and secondary schools, colleges; and ° Hospitals/ nursing and residential care facilities. These facilities are arrayed across the size categories as follows: 41,749 small, 54,036 medium, and 12,351 large. 25 For the purposes of evaluating the potential impact of section 112.1( d)( 6), EPA assumes that 10 percent (or 4, 175) of small facilities, 50 percent (or 27,018) of medium facilities, and 75 percent (or 6, 175) of large facilities have wastewater treatment systems that are covered by the exemption. This assumption reflects a situation where the chances of having on­ site wastewater treatment increases with the size of a facility. One outcome of the wastewater treatment exemption is that a facility's SPCCrelated storage capacity could decrease. As a result, some facilities may no longer need an SPCC plan, while some medium and large facilities might shift to the next lower size category. Although EPA believes that larger facilities are more likely to have applicable wastewater treatment systems, such facilities are expected to have more oil storage and, therefore, are less likely to fall below SPCC capacity thresholds. If EPA assumes that 50 percent of the small facilities, 5 percent of the medium facilities, and 1 percent of the large facilities with applicable wastewater treatment systems leave the SPCC universe, then approximately 3, 500 existing facilities would no longer be 63 required to maintain SPCC plans – although EPA assumes they would incur some costs in reviewing the final rule and calculating their wastewater treatment capacity to determine their new status. If EPA assumes that 20 percent of medium and large facilities with applicable wastewater treatment systems shift to the next lower size category, 6,639 facilities would experience a change in their costs of maintaining SPCC plans. EPA assumes that section 112.1( d)( 6) will result in all facilities with applicable wastewater treatment systems and still in the SPCC universe – 33,868 facilities – will need to amend their plans. Exhibit 3­ 13 shows the resulting distribution of existing and new SPCC facilities among the size, production, and storage categories after adjusting for the possible impact of section 112.1( d)( 6). EPA assumes that additional three revisions to the number of SPCC­ regulated facilities will be incremental to the figures in Exhibit 3­ 13. EXHIBIT 3­ 13 Number of Existing and New Facilities after Applying Section 112.1( d)( 6) (First Year) Small Medium Large Total Storage 244,118 54,520 12,426 311,064 Existing Production 127,799 26,589 322 154,709 Total 371,916 81,109 12,748 465,774 Storage 2,441 545 124 3,111 New Production 1,278 266 3 1, 547 Total 3,719 811 127 4,658 Total 375,635 81,920 12,876 470,431 In addition to reducing burden and costs to SPCC facilities, EPA expects the wastewater treatment exemption will also affect the number of facilities that require an FRP. The FRP rule (40 CFR 112.20­ 21) requires that owners or operators of facilities that could cause "substantial harm" to the environment by discharging oil into navigable waters or adjoining shorelines prepare plans for responding, to the maximum extent practicable, to a worst case discharge of oil, to a substantial threat of such a discharge, and, as appropriate, to discharges smaller than worst case discharges. All facilities subject to this requirement must submit their plans to EPA. In turn, EPA reviews and approve plans submitted by facilities identified as "significant and substantial harm" to the environment from oil discharges. Other facilities are not required to prepare FRPs but are required to document their determination that they do not meet the "substantial harm" criteria. 64 Prior to the final rulemaking, EPA estimated that large facilities would require between 99 and 132 hours and that medium facilities would require between 26 and 46 hours to comply with the annual, subsequent­ year reporting and recordkeeping requirements of the FRP rule. EPA also estimated that, prior to the final rulemaking, newly regulated large and medium facilities would require between 253 and 293 hours and 109 and 142 hours, respectively, to prepare a plan in the first year. Absent the wastewater treatment exemption, EPA estimates that the total number FRP facilities affected in the first year would have been 6,000 existing and 70 new facilities. Exhibit 3­ 14 illustrates the expected change in the number of FRP facilities that could be affected by the final SPCC rule. Based on information received from Regional personnel, EPA estimates that approximately 2. 5 percent of existing FRP facilities may include wastewater treatment (144 facilities). Of these facilities, EPA assumes 60 percent of the medium facilities (11 facilities) and 20 percent of the large facilities (24 large facilities) would no longer be required to comply with FRP requirements. EPA also assumes that 30 percent of large facilities (38 facilities) with wastewater treatment would now be considered medium­ sized facilities, due to a recalculation of capacity to exclude applicable wastewater treatment. Through the final rulemaking the estimated number of facilities required to maintain FRP plans is reduced to 5,965. With the final SPCC rule, EPA assumes that approximately six fewer new facilities would be added each year due to the overall reduction in the SPCC regulated universe. The number of new facilities affected by the wastewater exemption at section 112.1( d)( 6) is negligible – EPA assumes that approximately 1 facility every four years would no longer be covered by FRP regulations because of the exemption. The reduction in the number of facilities required to prepare, submit, and/ or maintain an FRP would result in an average annual information collection burden reduction of 8,513 hours a year, yielding a total of 25,538 hours. 65 EXHIBIT 3­ 14 Baseline and Adjusted Number of Existing and New FRP Facilities (First Year) Small Medium Large Total Existing 0 1, 020 4,980 6,000 Baseline New 0 125870 Total 0 1, 032 5,038 6,070 Existing 0 1, 046 4,919 5,965 Adjusted New 0 115364 Total 0 1, 057 4,972 6,029 Existing 0 26 (61) (35) Difference New 0 (1) (5) (6) Total 0 25 (66) (41) Final 40 CFR 112.1( d)( 2)( i) and 112.1( d)( 4) To estimate the burden reduction associated with eliminating completely buried tanks subject to all of the technical requirements of 40 CFR part 280 or of a State program approved under 40 CFR part 281, from the SPCC program, EPA conducted the analysis in two separate steps. First, EPA determined the total number of facilities in the Survey that were regulated solely because of their completely buried tanks and extrapolated this number to the universe of regulated facilities to determine the national estimate of facilities that would drop out of the program due to a completely buried tank exemption. Second, EPA estimated the number of facilities that would experience a significant decrease in burden because they would no longer have to include their completely buried tanks in their SPCC Plan. To estimate this number, EPA relied on a model facility approach. The model facility approach characterizes the universe in terms of small, medium, and large facilities, which is dependent on a facility's number of tanks and estimated storage capacity. Some facilities, as a result of a completely buried tank exemption, would have their facility classification change from a medium to a small facility due to a change in their regulated storage capacity. EPA estimated the number of facilities that would change classification by screening Survey data and extrapolating the findings to derive a national estimate. While these facilities would still be regulated under the SPCC program, their annual paperwork burden would be significantly reduced to warrant a re­ classification because of a change in their regulated storage 26 EPA conducted this analysis using a 1, 320 gallon or less aboveground storage capacity threshold to avoid a possible double counting of the number of facilities that may be affected under both revisions. 27 Some facilities could have aboveground storage capacity between these thresholds but still be regulated under this rule if the facility had greater than 42, 000 gallons of completely buried storage capacity. To estimate the burden reduction effects of this option, EPA did not include facilities with greater than 42, 000 gallons completely buried storage capacity in their burden reduction estimate. 66 capacity. In reality, all facilities with regulated completely buried tanks would experience a decrease in burden and capital costs so it is likely that EPA's estimate understates the true effect. Based on an analysis of Survey results, EPA estimates that about 51,000 facilities will be affected by this revision. 26 Out of this total, about 14,000 facilities – the majority of which are likely to be gasoline service stations – will no longer be regulated under part 112. The other facilities will likely experience a reduction in burden, even though they will remain regulated, as their SPCC Plans will no longer need to discuss a completely buried tank regulated under 40 CFR part 280. This revision will decrease aggregate capital­ costs for regulated facilities because of the reduced number of such facilities. The effects are discussed in greater detail in Section 3. 5. 1 of this analysis. Final 40 CFR 112.1( d)( 2)( ii) EPA is revising the rule to no longer regulate a facility having a single container with a storage capacity greater than 660 gallons, but aggregate aboveground storage capacity of 1, 320 gallons or less of oil. To estimate the number of facilities that would benefit from this regulatory threshold change, EPA analyzed Survey results for the number of facilities with a total aboveground oil storage capacity between 660 and 1,320 gallons in a single tank. 27 Analysis of the Survey data showed that about 10.5 percent of small facilities would no longer be regulated if this option was enacted. As a result, EPA expects that about 39,231 small facilities will no longer be regulated (38,839 existing facilities and 392 new facilities). Of this total, approximately 70 percent, or about 27,500 facilities are small farms. Other industries that are likely to experience a significant decrease in the number of regulated facilities include primary and secondary schools and colleges as well as gasoline service stations. The remaining number of facilities are evenly distributed among the manufacturing and transportation sectors of the economy. This revision will decrease aggregate capital­ costs for regulated facilities because of the reduced number of such facilities. The effects are discussed in greater detail in Section 3. 5.1 of this analysis. Final 40 CFR 112.1( f) 28 1993 Notice of Proposed Rulemaking Economic Impact Analysis of the Proposed Revisions to the Oil Pollution Prevention Regulation. 67 EPA is granting its Regional Administrators the authority, on a case­ by­ case basis, to require any facility subject to CWA section 311( j) to prepare and implement a total or partial SPCC Plan where necessary to carry out the purposes of the CWA. This provision will apply to any facility that would otherwise be exempted from compliance with the regulation (such as a facility with a completely buried tank subject to all of the technical requirements of 40 CFR part 280 or a State program approved under 40 CFR part 281 that will be exempted under 40 CFR 112.1( d)( 4)). An otherwise exempted facility that is required to prepare a total or partial Plan will incur costs to prepare that Plan and fulfill all other SPCC requirements, including all rule revisions. The main compliance activities are:
Prepare the SPCC Plan (40 CFR 112.7);
Submit information in the event of certain discharges of oil (40 CFR 112.4);
Revise the SPCC Plan following modification of the facility (40 CFR 112.5( a)); and
Maintain the SPCC Plan and keep records (40 CFR 112.3 and 112.7). The RAs are expected to exercise their authority only in unusual circumstances on a facility­ by­ facility basis. The number of affected facilities has been estimated by Regional personnel at 10 facilities or fewer per Region. This estimate is used for purposes of this analysis. The average calculated cost per affected facility to comply with all the SPCC paperwork­ related requirements is the same as the average unit cost for a new facility. EPA assumes that out of the approximately 100 facilities each year that will be affected by this provision, 60 percent will be small facilities, 30 percent will be medium facilities, and 10 percent will be large facilities. 28 This revision will increase aggregate capital­ costs for regulated facilities because of the increased number of such facilities. The effects are discussed in greater detail in Section 3. 5. 1 of this analysis. Exhibit 3­ 15 summarizes the effects that the above three revisions will have on the number of SPCC regulated facilities. The exhibit shows that approximately 51,398 facilities, representing nearly 11 percent of the entire SPCC­ regulated universe, will no longer be subject to the requirements of the SPCC rule. Of this total, approximately 36, 000 are small facilities and approximately 14,500 are medium facilities. The facilities most likely to be affected by these changes are farms due to the change in the minimum aboveground storage capacity threshold and gasoline service stations due to the exemptions of completely buried tanks that are subject to all of the technical requirements of EPA's UST program. 68 29 From the 1997 Screening Analysis of the Spill Prevention, Control, and Countermeasure Program Impacts on Small Entities. The dollar values in the report were updated to 2001 dollars in Exhibit 3­ 15. 69 EXHIBIT 3­ 15 Adjusted Number of Existing and New Facilities (First Year) Small Medium Large Total Storage 224,231 41,191 11,587 277,012 Existing Production 117,388 20,088 300 137,773 Total 341,619 61,279 11,887 414,785 Storage 2,282 432 126 2,837 New Production 1,194 211 3 1, 411 Total 3,476 643 129 4,248 Total 345,095 61,922 12,016 419,033 3. 5 TOTAL COSTS This section presents the estimated total costs to small, medium, and large facilities of complying with the revisions to the Oil Pollution Prevention regulation. The revisions to the final rule will affect both the capital costs to facilities and their paperwork burden. Both effects are detailed below. 3.5.1 CAPITAL COSTS Four of the revisions to the final rule are expected to result in decreased aggregate capital costs to facilities. Specifically, provisions 112.1( d)( 2)( i), 112.1( d)( 2)( ii), 112.1( d)( 6), and 112.1( f) will alter the universe of regulated facilities, thereby changing the total capital costs to regulated facilities. Three of the provisions – 112.1( d)( 2)( i), 112.1( d)( 2)( ii), and 112.1( d)( 6) – will decrease the number of regulated facilities, and thus reduce the aggregate capital costs posed to the regulated community. Only provision 112.1( f) will act to increase aggregate capital costs. Exhibit 3­ 16 shows the estimated unit capital costs (the non­ paperwork­ related annual compliance costs) to both existing and new storage and production facilities in each size category. 29 Existing facilities that will now become exempt from the SPCC rule will save about $191 to $1,743 per year on recurring equipment maintenance, drainage system upkeep, and training costs. New facilities that will not be subject to the revised rule also will save initial costs of about $3,136 to $165,464 to purchase and install 30 ibid. 70 equipment. 30 The four provisions' cumulative effects on the universe of facilities following the first year after the final rule revisions is presented in Exhibit 3­ 17. EXHIBIT 3­ 16 Estimated Capital­ Related Annual Compliance Cost per Model Facility Type of Facility Small Medium Large Existing Storage $191 $616 $1,743 Production $191 $555 $1,505 New Storage $3,136 $40,190 $165,464 Production $3,136 $37,185 $153,447 EXHIBIT 3­ 17* Change in the Size of the Regulated Community Due to Final Rule Revisions (First year) Type of Facility Small Medium Large Total Existing Storage (16,570) (18,849) (2,136) (37,553) Production (10,411) (6,501) (22) (16,936) New Storage (126) (168) (12) (309) Production (83) (55) 0 (136) Total (27,191) (25,573) (2,170) (54,933) *The numbers in this exhibit are approximations due to rounding. To determine the total change in capital costs, the change in the regulated community was multiplied by the estimated capital­ related compliance costs. The results are presented in Exhibit 3­ 18. In total, the final rule revisions are expected to provide the regulated community with a first­ year capital­ cost savings of approximately $29.47 million. 71 EXHIBIT 3­ 18* Change in Aggregate Capital Costs Due to Final Rule Revisions (Million $) Type of Facility Small Medium Large Total Existing Storage ($ 3.89) ($ 8.37) ($ 1.45) ($ 13.71) Production ($ 1.84) ($ 3.34) ($ 0.03) ($ 5.21) New Storage ($ 0.37) ($ 6.26) ($ 1.78) ($ 8.41) Production ($ 0.24) ($ 1.90) $0.00 ($ 2.14) Total Capital Costs Change ($ 6.34) ($ 19.86) ($ 3.26) ($ 29.47) *The numbers in this exhibit may not add precisely due to rounding. 3. 5. 2 PAPERWORK BURDEN The revisions to the final rule are expected to reduce the total paperwork cost burden posed to SPCC and FRP facilities in each size category. These reductions are presented in Exhibit 3­ 19. Total costs increase by about $24.40 million for existing facilities during the first year following the regulation's implementation, but decreases by approximately $57.71 million in the second year and $42.50 million per year in subsequent years. For new facilities, total costs decrease by over $2. 46 million during the first year, $2. 50 million in the second year, and over $2. 53 million per year in subsequent years. Regulated facilities will experience an increase in total paperwork costs in the first year of the regulation's implementation of about $21.93 million. This increase is primarily associated with the one­ time burden to read and understand the revisions being made to the SPCC rule, along with a slight increase in burden associated with two other one­ time activities: 1) supplementing existing SPCC Plans with a crossreference matrix, and 2) adding a facility diagram to the Plan. In addition, certain facilities will recalculate their storage capacity to exclude applicable wastewater treatment systems and, therefore, must amend and certify their plans if the storage capacity threshold is still met. In certain cases, however, the treatment system provision in section 112.1( b)( 6) will result in a facility no longer being subject to the any Part 112 requirements. EPA also expects a reduction in the number of facilities required to prepare and maintain a facility response plan. During the second year, total paperwork cost burden will decrease by about $60.21 million and beginning in the third year following the rulemaking, the total paperwork cost burden to all regulated facilities will decrease by about $45.03 million. 72 3. 5. 3 AGGREGATE SAVINGS The reduction in size of the regulated community due to final rule revisions will lead to a capital­ cost savings of approximately $29.47 million per year. During the first year, regulated facilities will experience an increase in total paperwork cost burden of $21.93 million due primarily to the need to read the rule. However, during the second year, total paperwork cost burden will decrease by about $60.21 million and beginning in the third year following the rulemaking, the total paperwork cost burden to all regulated facilities will decrease by about $45.03 million. The result is an aggregate cost savings of about $7.56 million during the first year, $89.69 million during the second year, and $74.51 million during subsequent years. 73 EXHIBIT 3­ 19 * ESTIMATED TOTAL FIRST­ YEAR AND SUBSEQUENT­ YEAR COSTS OF THE FINAL REVISIONS (Million $) Provision or Activity First Year Second Year Each Subsequent Year ** Existing Facilities Five­ Year Review ­ §112.5( b) Small Facilities Medium Facilities Large Facilities Total ($ 21.19) ($ 6.84) ($ 1.58) ($ 29.61) ($ 21.19) ($ 6.84) ($ 1.58) ($ 29.61) ($ 9.41) ($ 3.93) ($ 0.78) ($ 14.12) Oil Discharge ­ §112.4( c) Small Facilities Medium Facilities Large Facilities Total 0.01) 0.01) 0.01) Plan Modification ­ §112.5( a) Small Facilities Medium Facilities Large Facilities Total ($ 2.34) $2.24 $0.69 $0.59 ($ 4.01) ($ 2.19) ($ 0.25) ($ 6.45) ($ 4.04) ($ 2.21) ($ 0.25) ($ 6.51) Recordkeeping Small Facilities Medium Facilities Large Facilities Total ($ 10.95) ($ 8.15) ($ 2.56) ($ 21.66) ($ 11.06) ($ 8.23) ($ 2.58) ($ 21.87) ($ 11.16) ($ 8.31) ($ 2.61) ($ 22.08) Cross­ Reference ­ §112.3( a) Small Facilities Medium Facilities Large Facilities Total $5.57 $1.00 $0.19 $6.76 Facility Diagram ­ §112.7( a)( 3) Small Facilities Medium Facilities Large Facilities Total $11.27 $2.41 $0.06 $13.74 Provision or Activity First Year Second Year Each Subsequent Year ** 74 Brittle Fracture Records ­ §112.7( i) Small Facilities Medium Facilities Large Facilities Total 0.22 $0.19 $0.40 0.22 $0.19 $0.41 0.22 $0.19 $0.41 Read and Understand Rule Small Facilities Medium Facilities Large Facilities Total $44.79 $7.99 $1.55 $54.34 FRP Wastewater Treatment Exemption Small Facilities Medium Facilities Large Facilities Total 0.02 ($ 0.18) ($ 0.15) 0.02 ($ 0.19) ($ 0.17) 0.02 ($ 0.21) ($ 0.19) Total Costs To Existing Facilities $24.40 ($ 57.71) ($ 42.50) New Facilities New Plan ­ §112.3( a) Small Facilities Medium Facilities Large Facilities Total ($ 1.07) ($ 0.92) ($ 0.14) ($ 2.14) ($ 1.09) ($ 0.93) ($ 0.16) ($ 2.17) ($ 1.09) ($ 0.79) ($ 0.12) ($ 2.00) Oil Discharge ­ §112.4( c) Small Facilities Medium Facilities Large Facilities Total Plan Modification ­ §112.5( a) Small Facilities Medium Facilities Large Facilities Total ($ 0.03) ($ 0.02) 0.05) ($ 0.03) ($ 0.02) 0.05) ($ 0.03) ($ 0.02) 0.05) Recordkeeping Small Facilities Medium Facilities Large Facilities Total ($ 0.11) ($ 0.09) ($ 0.02) ($ 0.22) ($ 0.11) ($ 0.09) ($ 0.02) ($ 0.22) ($ 0.11) ($ 0.09) ($ 0.02) ($ 0.22) Provision or Activity First Year Second Year Each Subsequent Year ** 75 FRP Wastewater Treatment Exemption Small Facilities Medium Facilities Large Facilities Total 0.00) ($ 0.04) ($ 0.05) 0.00) ($ 0.05) ($ 0.06) 0.00) ($ 0.05) ($ 0.06) Total Costs To New Facilities ($ 2. 46) ($ 2. 50) ($ 2. 53) All Facilities Total Costs To All Facilities $21.93 ($ 60.21) (45.03) * The numbers in this exhibit may not add precisely due to rounding. ** The figures presented here are minimum estimates. Costs and cost savings are expected to grow over time as the number of regulated facilities grows. Note: Facility size categories are defined as follows: a small facility is assumed to have aboveground storage capacity greater than 1,320 gallons total but less than or equal to 42,000 gallons; a medium facility is assumed to have total storage capacity greater than 42,000 gallons but less than or equal to one million gallons; a large facility is assumed to have total storage capacity greater than one million gallons. 76 CHAPTER 4 PUBLIC HEALTH AND WELFARE, AND ENVIRONMENTAL EFFECTS 4. 1 INTRODUCTION Discharges of both petroleum and non­ petroleum oils into the nation's marine and freshwater environments have the potential to cause damages to public health and welfare, and to the environment. Discharges from SPCC facilities can occur whenever oil is handled or stored during production, transfer, use, or disposal. Causes of discharges include human error (e. g., improper reaction conditions and overfilling tanks during transfer operations), equipment failure (e. g., deteriorated seals and ruptured pipes or tanks), and improper storage or abandonment. 4. 2 EFFECTS OF OIL DISCHARGES INTO MARINE OR FRESHWATER ENVIRONMENTS Studies have documented nature's ability to recover over time from the damage caused by a large oil discharge. Nevertheless, the impact of such large discharges into either the marine or freshwater environment can be devastating in the short­ term, and some of the effects may last for years or even decades. Both the extent of biological damage caused by a discharge and the speed of recovery depend on many factors, including the following: geographic location, quantity of oil spilled, characteristics of the area affected, oceanographic conditions, weather conditions, the season, the type of oil, and the nature of the response. Physical, chemical, and biological transformations of discharged oil begin immediately upon introduction to marine or freshwater environments. The rate and degree of transformation depend on several factors related to advective and spreading processes. Advection is caused by the influence of overlying winds and underlying currents on the oil, while spreading results from the interplay among the forces of gravity, inertia, friction, viscosity, and surface tension. These two processes cause a rapid increase in the exposure area of the oil to subsequent "weathering." Oil spreads on the surface of water, forming a "slick" that tends to move or drift with waves, currents, and wind. The rate of spreading depends on the type of oil, its volume, wind and sea conditions, and the amount of weathering that occurs. A thicker region of an oil slick will drift more rapidly than a thinner one, so that thicker regions tend to accumulate at the leading edge of a drifting slick. The toxicity of the discharge depends on oil type. Freshly discharged crude is more acutely toxic than weathered oil because of the presence of the more toxic volatile constituents, which quickly evaporate or dissolve. Similarly, lighter refined 31 U. S. Department of Energy, Report to Congress on Candidate Sites for Expansion of the Strategic Petroleum Reserve to One Billion Barrels, Office of Strategic Petroleum Reserve, March 1991, Document Number DOE/ FE­ 0221P. 77 products (e. g., diesel fuel and gasoline) are more acutely toxic than crude but dissipate more rapidly. The specific properties of the discharged oil (e. g., density and viscosity) determine the susceptibility of a spill to weathering. Weathering processes include evaporation, dissolution, vertical dispersion, emulsification, and sedimentation. Emulsification in particular can expand the initial discharge volume considerably as oil and water mix to form a mousse. For persistent oils, emulsification can increase initial spill volume by a factor of 2 to 3, depending on the type of oil. The longer the discharged oil remains in rough seas, the greater the likelihood of a mousse occurring. A mousse may also occur in quiescent waters. The viscosity of oil also changes as the oil is exposed to these weathering processes. High viscosity oils are more difficult to recover mechanically (e. g., pump) and disperse than low viscosity oils. Weathering processes tend to increase the viscosity and may make mechanical recovery and removal of spilled oil from water more difficult. Over time, the discharge spreads into a thin layer and continues to break down, fragmenting into smaller patches. These patches may cover even larger surface areas than the initial discharge due to drifting. Depending on the location of the discharge, as well as weather and oceanographic conditions, some of the oil may affect shoreline areas. Unlike ocean spills that are dispersed by wind and wave action, oil discharged near the shoreline typically concentrates and mixes with near­ shore waters or collects along shorelines. As a result, wetlands, seagrass beds, beaches, rocky habitats, coral reefs, intertidal areas, and terrestrial ecosystems may be damaged. Oil deposited in near­ shore sediments persists longer than in ocean sediments. Oil is particularly persistent in low­ energy, wetland habitats. 31 High­ energy, rocky shores tend to self­ clean within a matter of months, whereas soft­ sediment lagoons, marshes, and mangrove swamps act as long­ term petroleum sinks. Pools of oil may collect between rocks and remain essentially unchanged for a long time. On cobble and sandy beaches, oil can sink deeply into the sediments and remain longer than on bare rocks. Sediment grain size and compaction determine the rate of penetration. In muddy sediments, only the upper few centimeters are 32 National Research Council, Oil in the Sea: Inputs, Fates, and Effects, National Academy Press, Washington, D. C., 1985. 33 U. S. Department of Energy, Report to Congress on Candidate Sites for Expansion of the Strategic Petroleum Reserve to One Billion Barrels, Office of Strategic Petroleum Reserve, March 1991, Document Number DOE/ FE­ 0221P. 34 National Research Council, Oil in the Sea: Inputs, Fates, And Effects, National Academy Press, Washington, D. C., 1985. 78 penetrated. However, because little physical weathering occurs in these environments, stranded oil can persist for decades. 32 Heavy oiling of the shore zone causes immediate, widespread death of plants and animals due to smothering and toxic effects. The long­ term effects are more variable and subtle, and depend on the type of petroleum discharged, climate, weather, resilience of the affected ecosystem, and numerous other factors. Attempts to clean beaches of oil may actually cause further ecological damage. The extent of possible additional damage depends on the cleanup technology used (e. g., hot­ and cold­ water washing, backhoeing and tilling, and manual oil removal). Hot­ water washing may destroy any surviving marine organisms in areas where the technique is applied. Additionally, the high pressure used in both hot­ and cold­ water washing can destabilize gravel and sand beaches. Shifting sediments then suffocate marine organisms that inhabit these areas, impeding recolonization. Furthermore, manual removal may damage some ecosystems more than if natural degradation of the oil were allowed to occur. Excessive removal of oiled sediments can also result in the disturbance of physical and ecological equilibrium. To varying degrees, coastal marine environments throughout the United States serve as breeding and nursing areas for resident and migratory species of fish and aquatic birds. Fish can be affected through ingestion of oil or oiled prey and uptake of dissolved petroleum compounds through the gills, or by changes in the ecosystem. Damage to fish eggs and larvae also may occur. The sensitivity of fish to oil spills varies by species and age class. In general, fish are very sensitive to short­ term acute exposures, but are able to metabolize sub­ lethal intakes. Fish in older age classes are able to avoid heavy contamination and have a mucous coating that helps them resist contact with toxic oil constituents. The youngest age classes are most vulnerable to oil spills. Oil may smother eggs, interfere with hatching success, or cause developmental abnormalities. 33 Many physiological, histological, and behavioral abnormalities caused by exposure to crude oil have been documented. 34 Aquatic birds, especially diving birds, are highly vulnerable to oil spilled in coastal areas. Feathers that are coated with oil become water­ logged and lose their 35 U. S. Department of Energy, Report to Congress on Candidate Sites for Expansion of the Strategic Petroleum Reserve to One Billion Barrels, Office of Strategic Petroleum Reserve, March 1991, Document Number DOE/ FE­ 0221P. 36 National Research Council, Oil in the Sea: Inputs, Fates, And Effects, National Academy Press, Washington, D. C., 1985. 79 insulating properties. As a result, birds may drown or die of hypothermia. Oil also may be ingested by birds as they preen. Birds suffer stress­ related effects as they attempt to detoxify the ingested oil. 35 Ingested oil can temporarily depress egg laying and reduce the hatching success of those eggs that are laid. 36 Disturbance of valuable habitats or resources also could indirectly affect birds through increased competition. Many waterfowl and shorebirds flock on salt marshes and mud flats (which tend to recover more slowly) and would be vulnerable if their feeding habitats were contaminated by oil spills. Oil discharges may also disrupt the structure and function of marine ecosystems. Differential rates of mortality resulting from oil spills shift food web relationships. The results for individual organisms are changes in resource availability, competition, and predation. On the population level, species that are dependent on affected prey or habitats will decline while opportunistic species may increase. Rare species, small local populations, or species that are seasonally concentrated in the impacted habitat are the most likely to decline as a result of an oil discharge. In addition to adverse effects on fish, aquatic birds, and marine ecosystems, human health may be at risk as a consequence of oil pollution of water. The main concern regarding the risk to humans is the known carcinogenicity of several of the oil components and exposure to toxic elements in oil through direct exposure or through oil­ tainted food. Human health risks also include hazards encountered by workers during cleanup operations. 4. 3 INCREMENTAL EFFECTS OF THE PROPOSED RULEMAKING ON MARINE AND FRESHWATER ENVIRONMENTS This economic analysis assumes that the revision to the Oil Pollution Prevention regulation will have a minimal effect on the above risks. Rather, the final changes to the rule will lessen the burden to the regulated community while maintaining a commensurate level of protection to human health and the environment. The revisions will affect regulated facilities in two manners. First, several of the final changes will reduce the number of facilities regulated by the SPCC program. The other revisions to the rule are designed to lessen the regulatory burden of paperwork­ related activities required of regulated facilities. Each of these effects and how the final changes to the rule would affect human health or welfare or the environment is discussed below. 80 4. 3. 1 REDUCING THE NUMBER OF REGULATED FACILITIES EPA is reducing the number of facilities subject to the SPCC program by altering the criteria for SPCC program applicability and dropping from the program completely buried containers currently subject to all of the technical requirements of 40 CFR part 280 or a State program approved under 40 CFR part 281. Under the final rule, any facility having an aboveground storage capacity of 1, 320 gallons or less of oil will no longer be regulated, nor will a completely buried container subject to all the technical requirements of 40 CFR part 280 or of a State program approved under part 281. Under the final rule, Regional Administrators may require any facility subject to the jurisdiction of EPA under section 311( j) of the CWA but otherwise exempt from the requirement to prepare a Plan under part 112 to prepare and implement a total or partial SPCC Plan where necessary to carry out the purposes of the CWA. EPA expects this provision to slightly increase the number of regulated facilities. In aggregate, however, the size of the regulated community will be reduced, with those facilities posing the least amount of environmental risk – the smallest facilities and facilities currently regulated under other programs – being excluded from the SPCC program. 4. 3. 2 REDUCING PAPERWORK­ RELATED REQUIREMENTS FOR REGULATED FACILITIES In addition to the Agency's revisions to reduce the number of facilities subject to the program, the Agency has also changed the existing rule language in several areas with the primary goal of reducing the paperwork burden to facilities that still must comply with the SPCC regulation. The Agency believes that the effect of these changes, in terms of increasing discharge risk, is negligible because prevention planning and recordkeeping activities would still be conducted in full in accordance with other standards (i. e., industry, State, or other Federal standards) or because the changes do not alter the basic objectives or intent of the regulation but only affect minor recordkeeping provisions. Three of the proposed rule changes are designed to increase the level of flexibility in formatting plans and in the manner in which records are created and maintained without compromising protection to public health or welfare, or the environment. First, by allowing facilities to deviate from the Plan format specified in the rule – as long as an equivalent plan is prepared, meets all the applicable requirements listed in the rule, is appropriately cross­ referenced, and is acceptable to the Regional Administrator – the Agency is giving facility owners or operators flexibility to use alternate formats. Similarly, EPA is allowing a facility owner or operator to deviate from most of the rules' substantive requirements if he explains his reasons for nonconformance and provides equivalent environmental protection. An owner or operator may deviate from the requirement to install secondary containment structures 81 or equipment if not practicable, provides a contingency plan following 40 CFR part 109, conducts periodic integrity testing of containers, and periodic integrity and leak testing of valves and piping. Again, the Agency is allowing flexibility in conforming with the rule's requirements while ensuring that equivalent environmental protection is maintained. Finally, records of inspections and tests maintained in accordance with usual and customary business practices, such as API 653 and 2610, will no longer have to be replicated for purposes of the SPCC Plan. The Agency is also allowing a facility owner or operator to submit less information in the event of a reportable discharge under §112.4( a). In these rare instances, the discharge would already have occurred and the effect of the Agency's rule change would simply alter the amount of information that a facility owner or operator is compelled to submit. The Agency, however, would still reserve the right to request additional information from the owner or operator if the Regional Administrator deems it necessary. Additionally, EPA is extending the period of time that a facility has to conduct a self review and evaluation of its Plan from three to five years. The Agency does not believe that this rule change would significantly increase the risk of discharges as a facility would still be required to amend its SPCC Plan under §112.5( a) whenever there is a change in facility design, construction, operation, or maintenance that materially affects the facility's potential for the discharge of oil as described in §112.1( b). Two revisions to the SPCC rule will decrease both the number of regulated facilities as well as the overall burden for other facilities that will continue to be regulated under the SPCC program. EPA is no longer regulating under the SPCC program a completely buried container that is subject to all of the technical requirements of 40 CFR part 280 or of a State program approved under 40 CFR part 281. The Agency is also no longer regulating any bulk storage container with a storage capacity of less than 55 gallons of oil. Facilities are expected to benefit from these revisions because facility owners or operators will no longer have to include a discussion of the aforementioned containers in their SPCC Plans. These revisions may also enable some facilities to no longer be regulated under the SPCC program; however, EPA notes that these facilities will either be regulated under other Agency programs or do not pose significant threat to the environment due to the nature of the facility. The Agency has also finalized a few revisions that may increase the burden to a regulated facility, but will likely decrease the risk that regulated facilities pose to the environment. EPA is requiring a facility owner or operator to include with his Plan a facility diagram, which must mark the location and contents of each container. This change will assist response personnel in to plan for emergencies. Additionally, fieldconstructed aboveground containers must be evaluated for risk of discharge or failure due to brittle fracture or other catastrophe when such a container undergoes a repair, 82 alteration, or a change in service that might affect the risk of a brittle fracture or other catastrophe. This change will reduce the risk of container failure from brittle fracture and other catastrophes. The increased level of burden posed by these revisions is expected to be minor in comparison to the burden savings offered by other finalized revisions. The revision that changes from eight to four the minimum hours that a facility must be attended to be required to maintain a complete copy of an SPCC Plan on the premises is expected to result in a negligible burden increase because the Plan previously must have been kept and maintained at the nearest field office if not at the facility. Finally, EPA is requiring all SPCC­ regulated facilities to amend their SPCC Plans to conform with the new sequence and requirements of the final rule, if necessary, within six months of the effective date of the final rule and implement the Plan within 12 months. Because the format and sequence of the rule has changed substantially and because many facilities will find that their existing SPCC Plan no longer follows the new sequence of the rule, the Agency has provided a crossreference template for facilities. The template is intended to make it easier for facilities to fulfill the requirements of 40 CFR 112.3( a), which will in turn pose a minor burden increase to regulated facilities but will not compromise protection to public health or welfare, or the environment. 83 CHAPTER 5 SMALL BUSINESS ANALYSIS The purpose of this chapter is to determine whether the changes being made to the U. S. Environmental Protection Agency's (EPA) Spill Prevention, Control, and Countermeasure (SPCC) requirements will likely have a significant economic impact on a substantial number of small entities. EPA is finalizing many of the changes proposed in 1991, 1993, and 1997. The proposals and the changes being finalized that affect small entities regulated by the rule are summarized below, along with the effect these changes are expected to have on small entities. 5. 1 REQUIREMENTS OF THE REGULATORY FLEXIBILITY ACT The Regulatory Flexibility Act (RFA) requires federal agencies to determine whether their regulatory actions will have a significant economic impact on a substantial number of small entities. If an agency does not or cannot certify that a proposed regulation will not have a significant economic impact on a substantial number of small entities, it must prepare a regulatory flexibility analysis and examine alternatives to the proposed regulation that may reduce adverse economic effects on significantly impacted small entities. In 1996, Congress enacted the Small Business Regulatory Enforcement Fairness Act (SBREFA), which amended the RFA to strengthen its analytical and procedural requirements and to expedite Congressional review of rules. SBREFA amended the RFA to reference the definition of a "small entity" found in the Small Business Act, which itself authorizes the Small Business Administration (SBA) to further define "small business" by regulation. The SBA's small business definitions are codified at 13 CFR 121.601 and the SBA reviews and reissues these definitions every year. 37 Screening Analysis of the Spill Prevention, Control, and Countermeasures Program Impacts on Small Entities, Oil Spill Program Center, U. S. EPA, 1997. 38 American Petroleum Institute. 1989 Aboveground Storage Tank Survey, April 1989; U. S. Environmental Protection Agency. Spill Prevention, Control, and Countermeasure Facilities Study, January 1991; Weiner, J. L. Nutshell Summary of EPA's National Survey of Oil Storage Facilities, 1997 International Oil Spill Conference. 39 This estimate includes 1, 000 military installations and 2, 300 facilities in Alaska and Hawaii. Military installations are federal facilities and therefore not covered as "persons" by the RFA. Also, the 1995 Survey did not extend to facilities in Alaska or Hawaii. The estimates given in the adjusted national estimate were derived from other sources and are not included in this analysis. However, impacts on facilities in these states are expected to be similar to those on facilities in other states. 84 5. 2 CHARACTERIZING ENTITIES REGULATED UNDER THE SPCC PROGRAM EPA conducted a screening analysis of the effects of the existing SPCC rule on small businesses in 1997. 37 Based on the results of that analysis, EPA determined that the SPCC rule did not have significant adverse impacts on small businesses because many small businesses had a total oil storage capacity that was less than the minimum threshold requirements to be regulated by the rule and because the estimated cost of compliance for the remaining facilities did not constitute a significant percentage of a firm's total revenues. The 1997 screening analysis relied on the results of several previous studies and analyses to characterize the entities regulated under the SPCC program. These studies include the American Petroleum Institute's 1989 survey of facilities with aboveground storage tanks, EPA's 1991 Facilities Study, and EPA's 1995 Survey. 38 The1995 national survey of oil storage and production facilities was used by EPA in part to estimate the number of these facilities subject to EPA's SPCC program. EPA compared the results of the SPCC Survey to previous government and industry studies and calculated a 1996 adjusted national estimate, which represented EPA's best approximation of the number of facilities regulated by the SPCC program. In 1996, EPA indicated that approximately 438,000 facilities had oil storage capacity great enough to be regulated under the SPCC program. 39 Assuming a one­ percent annual growth rate in the number of facilities, EPA estimates the number of regulated facilities to have grown by about 36,000, yielding a current total estimate of 474,000 facilities. These facilities are predominantly found in seventeen industry sectors. Exhibit 5­ 1 presents a breakdown by SIC code and corresponding NAICS code of the different industry sectors that contain the majority of SPCC facilities, as well as the distribution of facilities by industry sector. The figures represent the 1996 adjusted national 85 estimates increased by the one­ percent annual growth rate. EPA estimates that most SPCC facilities are located in either the agricultural sector of the economy (174,973 facilities) or the oil production sector of the economy (154,709 facilities). According to these figures, these sectors together account for about 70 percent of the total number of SPCC facilities. 86 EXHIBIT 5­ 1 PRIMARY INDUSTRY SECTORS, SIC CODES, CORRESPONDING NAICS CODES, AND ESTIMATED NUMBER OF SPCC FACILITIES Industry Standard Industrial Classification Code (SIC) North American Industry Classification System (NAICS) Estimated Number of Regulated SPCC Facilities (CY 2002) Farms 01 111 174,973 Coal Mining, Nonmetallic Mining 12/ 14 2121, 2123, 2131 54136 1,930 Oil Production 131 211111 154,709 Contract Construction 16 2341, 2349 7,719 Food and Kindred Products 20 311, 3121 4,610 Chemicals and Allied Products 28 2111, 3119, 325, 3313 3,538 Petroleum Refining and Related Industries 29 3241 1,716 Primary Metals 33 3241, 331, 332, 3359 751 Other Manufacturing 20­ 39 31­ 33 16,618 Transportation 401/ 411/ 413/ 4 14/ 417/ 42/ 449/ 458 4821, 484 ­5, 4871, 488, 4922, 4931, 5311, 5324, 56172, 5621, 6219, 7139 17,691 Pipelines 46 4861, 4869 644 Electric Utility Plants 491 2211 3,967 Petroleum Bulk Stations and Terminals 5171 4543, 4227 10,293 Gasoline Service Stations/ Vehicle Rental 554/ 751 4471, 5321 13,938 Fuel Oil Dealers 5983 4543 4,181 Health Care/ Education 801/ 802/ 803/ 8 04/ 805/ 806/ 80 7/ 821/ 822 3391, 61111, 61131, 61121, 621, 623 5,575 Other Commercial Facilities NA NA 42,885 Military/ AK/ HI NA NA 3, 538 Total NA NA 469,274 40 SBA has revised the definition of small business and published a new table of small business size standards based on industries as they are defined by the North American Industry Classification System (NAICS). The outcome of this analysis, while it depends on SIC based definitions, would not change noticeably if it used NAICS­ based definitions. For further information about why the analysis is not expected to change, please refer to the memo in the SPCC docket titled, Effects of Revisions to the Definition of small business on EPA's SPCC Analyses. For reference purposes, Exhibit 5­ 1 shows SIC codes, their corresponding NAICS codes, and the number of SPCC facilities. At the level of detail used in this analysis, the SBA definition provided in Exhibit 5­ 2 captures most of the same facilities whether they are classified by SIC or NAICS. 87 The industry sectors identified in the 1996 adjusted national estimate and listed above were developed based on EPA's 1991 Facilities Study and the 1995 SPCC Survey. To determine the industry sectors containing potentially regulated facilities, EPA's 1991 Facilities Study examined several state databases of facilities that store oil. All of the databases included the facility name and storage capacity, and some databases also had the SIC Code or other industrial classification for the facility. Using this information, EPA identified the industry sectors containing facilities that met the SPCC storage capacity thresholds. For each industry sector in each of the states examined, EPA divided the number of potentially regulated facilities by the total number of facilities in that industry sector in that state, determined from Census data. These fractions were applied to the national totals from the Census to obtain estimates of the total number of potentially regulated facilities in each industry sector. Similarly, EPA's 1995 SPCC Survey determined the fraction of potentially regulated facilities in each industry sector sampled and extrapolated the results to obtain national estimates. The total number of entities in each industry sector was determined using data from the 1992 U. S. Census at the four­ digit SIC­ code level. Census data were obtained to some degree for all industry sectors except electric utility plants. This industry is unique in that the SBA defines small electric utilities in terms of megawatt hours of output, rather than number of employees or annual revenues. Because the Census does not aggregate data for this industry in terms of megawatt hours, a different data source, the Energy Information Administration's (EIA) 1995 Form 861 data, was used. The EIA provides both output and revenue data at the individual utility level for virtually all private and public utilities in the U. S. Next, the number of affected small entities was estimated using the SBA definition of a small business. 40 SBA defines a small business as one that is independently owned and operated and is not dominant in its field. Depending on the industry, size standard eligibility is based on the average number of employees for the preceding 12­ months or on sales volume averaged over a three­ year period. 88 Exhibit 5­ 2, below, presents the SBA definitions that were used in the 1997 screening analysis to identify small businesses for the main industry sectors affected under the SPCC program. Although these definitions may now be different, they are presented here to be consistent with other data used in the 1997 analysis. Any new definitions are not expected to affect the general conclusion that the revisions will have negligible adverse impacts on small entities. Exhibit 5­ 3 compares the total number of small entities within each category to the total number of entities identified by the 1992 Census. The exhibit shows that the SBA definition of small entities used in the 1997 screening analysis encompassed 94 percent or more of the total number of firms or establishments identified by the 1992 Census. 89 EXHIBIT 5­ 2 SBA DEFINITION OF SMALL ENTITY FOR PRIMARY SPCC INDUSTRY SECTORS USED IN THE 1997 SCREENING ANALYSIS Industry SBA Definition of Small Entity Farms $0. 5 million Coal Mining/ Nonmetallic Mining 500 employees Oil Production 500 employees Contract Construction $17.0 million Food and Kindred Products 500 employees Chemicals and Allied Products 500 employees Petroleum Refining and Related Industries 500 employees Primary Metals 500 employees Other Manufacturing 500 employees Transportation $5. 0 million Pipelines 1,500 employees Electric Utility Plants 4 million MWh (total output) Petroleum Bulk Stations and Terminals 100 employees Gasoline Service Stations/ Vehicle Rental $6. 5 million/$ 18.5 million Fuel Oil Dealers $9. 0 million Health Care/ Education $5. 0 million Other Commercial Facilities $5. 0 million 90 EXHIBIT 5­ 3 NUMBER AND PERCENTAGE OF SMALL ENTITIES IN PRIMARY SPCC INDUSTRY SECTORS (1992 ESTIMATES) Industry U. S. Census Estimate of the Total Number of Firms/ Estab. s Approximate Number of SBA­ Defined Small Entities Percentage of Firms/ Estabs. Defined as Small Entities Farms 1, 925,300 1,878,386 98% Coal Mining/ Nonmetallic Mining 8, 873 8, 821 99% Oil Production 7,616 7,592 100% Contract Construction 37,180 37,180 100% Food and Kindred Products 20,798 20,240 97% Chemicals and Allied Products 12,004 11,699 97% Petroleum Refining and Related Industries 2,124 2,077 98% Primary Metals 6, 501 6,286 97% Other Manufacturing 329,485 325,929 99% Transportation 99,536 95,463 96% Pipelines 86 86 100% Electric Utility Plants 3, 215 3, 029 94% Petroleum Bulk Stations and Terminals 7,871 7,755 99% Gasoline Service Stations/ Vehicle Rental 59,075 56,972 96% Fuel Oil Dealers 4, 156 4,019 97% Health Care/ Education 382,813 372,734 97% Other Commercial Facilities 2, 669,972 2,543,529 95% Total 5, 576,605 5,381,797 97% 5. 3 THE EFFECTS OF THE RULEMAKING ON SMALL ENTITIES To assess the impacts on small entities affected by the SPCC rulemaking revisions, EPA developed a more detailed characterization of small entities within the main SPCC industry sectors, because using a single industry average to characterize all small entities within a single industry sector could possibly overlook significant impacts on the smallest of the small entities. Specifically, in 1997, EPA subdivided 91 each industry into several size categories, based on the SBA definition of a small entity for that industry. EPA obtained the number of firms in each size category and the total revenue for all firms in that category from the 1992 Census. The Agency then estimated the average revenue for a firm within each group by dividing the total revenue for each group by the total number of firms. Because a firm could be associated with several SPCC facilities, EPA determined the likely number and types of model facilities that a firm in each industry and size category may own. EPA has estimated the unit costs of the revised provisions in the final rule that may increase burden on facilities subject to the SPCC requirements. EPA calculated the cost to firms based on model facility cost estimates. In most cases, especially when the number of firms in an industry exceeded the number of SPCC facilities, the Agency assumed that each firm was associated with at most a single SPCC facility. To determine the likelihood of an adverse impact on a typical firm within each size category, EPA compared the estimated costs of the revisions – in 2001 dollars – to the 1992 average annual revenue for a firm in that category. EPA assumes that this approach will overestimate the potential impacts for individual firms. To estimate the total number of small entities affected, EPA assumes that the estimated impact on the average firm within a given size category represents the potential impact on each firm in that size category. Exhibit 5­ 4 shows the cost associated with the main revisions that could increase burden. These estimates are based on the exhibits in Section 3.3. Of course, most of the regulatory changes will reduce reporting and recordkeeping burdens. Nevertheless, those provisions have not been included in this analysis to determine whether the rulemaking may produce a significant adverse impact. EXHIBIT 5­ 4 Estimated Annual Costs from Key Revisions That Increase Burden Annual Cost per Facility (2001 dollars) Costs Small Medium­ Large Large Cross­ Reference $16 $16 $16 Facility Diagram $33 $39 $5 Brittle Fracture Records $0 $4 $16 Read and Understand Rule $130 $130 $130 92 Total $180 $190 $168 For each main industry sector, EPA presents information from the 1997 screening analysis on the number of firms that were under the SBA definition of a small business and the average revenue per firm within several revenue or employment size categories as of the 1992 Census. The number of SPCC facilities, if any, that the Agency believed were likely to be associated with firms in each size category (as of the 1997 screening analysis) are also shown. For those firms identified in 1997 as likely to be regulated, average revenues (1992 dollars) are compared to the estimated cost (2001 dollars) of the final rulemaking revisions for a firm to estimate a percentage impact per SPCC­ regulated firm. Generally, the smallest firms are expected to have little or no oil storage capacity, while the larger firms are expected to have greater amounts of oil storage capacity. Within some size categories, a range of estimates is given, because it is likely that SPCC­ regulated firms are associated with more than one type of model facility. For most industry sectors, EPA determined the distribution of small, medium, and large model facilities based on the total number of firms reported by Census and the total number of SPCC facilities as determined in previous Agency analyses. Industry­ specific assumptions made by the Agency concerning the estimation of impacts are discussed for each industry. This section only examines the impacts to small businesses relative to a base year of 1992 and does not address impacts to larger businesses. 93 EXHIBIT 5­ 5 Distribution of Farms Classified as Small Businesses by Agricultural Revenue Size (SIC Codes 01/ 02) Total Number of Farms (1992) Number of SPCCRegulated Facilities (1996) Total Revenue (Farms) ('000 dollars, 1992) Average Revenue per Farm ('000 dollars, 1992) Cost of Revisions per SPCC­ Regulated Farm (2001) %Impact per SPCCRegulated Farm Sales < $1,000 212,580 0 $57,709 $0.27 $0 0.00% Sales $1,000 ­ $2,499 210,187 0 $353,403 $1.68 $0 0.00% Sales $2,500 ­ $4,999 231,867 0 $835,832 $3.60 $0 0.00% Sales $5,000 ­ $9,999 251,883 0 $1,796,553 $7.13 $0 0.00% Sales $10,000 ­ $19,999 232,067 0 $3,291,314 $14.18 $0 0.00% Sales $20,000 ­ $24,999 69,737 0 $1,549,347 $22.22 $0 0.00% Sales $25,000 ­ $39,999 134,582 0 $4,259,990 $31.65 $0 0.00% Sales $40,000 ­ $49,999 60,772 0 $2,706,693 $44.54 $0 0.00% Sales $50,000 ­ $99,999 187,760 0 $13,516,761 $71.99 $0 0.00% Sales $100,000 ­ $249,999 208,405 102,118 $32,710,764 $156.96 $180 0.11% Sales $250,000 ­ $499,999 78,546 38,488 $26,914,023 $342.65 $180 0.05% 94 EXHIBIT 5­ 6 Distribution of Establishments in the Coal and Nonmetallic Mining Industries Classified as Small Businesses by Employment Size (SIC Codes 12/ 14) Total Number of Estab. s (1992) Number of SPCCRegulated Facilities (1996) Total Revenue (Estab. s) ('000 dollars, 1992) Average Revenue per Estab. ('000 dollars, 1992) Cost of Revisions per SPCC­ Regulated Estab. (2001) %Impact per SPCCRegulated Estab. Coal Mining 0 ­ 4 employees 830 0 $565,800 $682 $0 0. 00% 5 ­ 9 employees 419 0 $419,900 $1,002 $0 0.00% 10 ­ 19 employees 582 0 $1,554,800 $2,671 $0 0.00% 20 ­ 49 employees 652 447 $4,331,700 $6,644 $180 ­ $190 0.00% 50 ­ 499 employees 560 384 $17,069,000 $30,480 $180 ­ $190 0.00% Nonmetallic Mining 0 ­ 19 employees 4,418 0 $3,211,400 $727 $0 0. 00% 20 ­ 249 employees 1,357 931 $7,694,200 $5,670 $180 ­ $190 0.00% 250 ­ 499 employees 3 2 $295,588 $92,062 $180 ­ $190 0.00% EXHIBIT 5­ 7 Distribution of Firms in the Oil Production Industry Classified as Small Businesses by Employment Size (SIC Code 131) Total Number of Firms (1992) Number of SPCCRegulated Facilities (1996) Total Revenue (Firms) ('000 dollars, 1992) Average Revenue per Firm ('000 dollars, 1992) Cost of Revisions per SPCC­ Regulated Firm (2001) %Impact per SPCCRegulated Firm 0 ­ 9 employees 6,216 6,216 $2,632,100 $423 $180 0.04% 10 ­ 19 employees 600 2,091 $1,623,800 $2,706 $627 0.02% 20 ­ 49 employees 500 4,439 $3,671,000 $7,342 $1,598 ­ $1,687 0.02% 50 ­ 99 employees 200 6,284 $5,811,800 $29,059 $5,656 ­ $5,970 0.02% 100 ­ 249 employees 32 2,822 $2,698,400 $84,325 $14,816 ­ $16,756 0.02% 250 ­ 499 employees 44 7,584 $8,420,200 $191,368 $28,957 ­ $32,749 0.02% 95 EXHIBIT 5­ 8 Distribution of Establishments in the Construction Industry Classified as Small Businesses by Revenue Size (SIC Code 16) Total Number of Estab. s (1992) Number of SPCCRegulated Facilities (1996) Total Revenue (Estab. s) ('000 dollars, 1992) Average Revenue per Estab. ('000 dollars, 1992) Cost of Revisions per SPCC­ Regulated Estab. (2001) %Impact per SPCCRegulated Estab. Sales < $100,000 6,291 0 $318,057 $51 $0 0.00% Sales $100,000 ­ $249,999 7,078 0 $1,183,140 $167 $0 0.00% Sales $250,000 ­ $499,999 6,299 0 $2,259,805 $359 $0 0.00% Sales $500,000 ­ $999,999 5,134 1,939 $3,637,836 $709 $180 0.03% Sales $1,000,000 ­ $2,499,999 5,651 2,134 $8,834,980 $1,563 $180 0.01% Sales $2,500,000 ­ $4,999,999 2,920 1,103 $10,356,805 $3,547 $180 0.00% Sales $5,000,000 ­ $9,999,999 1,903 1,012 $13,359,385 $7,020 $168 ­ $190 0.00% Sales >= $10,000,000 1,904 1,013 $58,578,174 $30,766 $168 ­ $190 0.00% EXHIBIT 5­ 9 Distribution of Establishments in the Food and Kindred Products Industry Classified as Small Businesses by Employment Size (SIC Code 20) Total Number of Estab. s (1992) Number of SPCCRegulated Facilities (1996) Total Revenue (Estab. s) ('000 dollars, 1992) Average Revenue per Estab. ('000 dollars, 1992) Cost of Revisions per SPCC­ Regulated Estab. (2001) %Impact per SPCCRegulated Estab. 1 ­ 4 employees 5,767 0 $2,046,000 $355 $0 0.00% 5 ­ 9 employees 2,886 826 $3,793,400 $1,314 $180 0.01% 10 ­ 19 employees 2,816 806 $8,304,600 $2,949 $180 0.01% 20 ­ 49 employees 3,569 1,021 $30,301,600 $8,490 $180 0.00% 50 ­ 99 employees 2,147 614 $46,984,400 $21,884 $180 ­ $190 0.00% 100 ­ 249 employees 2,139 612 $97,147,900 $45,417 $180 ­ $190 0.00% 250 ­ 499 employees 916 262 $82,756,800 $90,346 $168 ­ $190 0.00% 96 EXHIBIT 5­ 10 Distribution of Establishments in the Chemicals and Allied Products Industry Classified as Small Businesses by Employment Size (SIC Code 28) Total Number of Estab. s (1992) Number of SPCCRegulated Facilities (1996) Total Revenue (Estab. s) ('000 dollars, 1992) Average Revenue per Estab. ('000 dollars, 1992) Cost of Revisions per SPCC­ Regulated Estab. (2001) %Impact per SPCCRegulated Estab. 1 ­ 4 employees 3,102 0 $1,703,200 $549 $0 0.00% 5 ­ 9 employees 1,937 718 $3,386,200 $1,748 $180 0.01% 10 ­ 19 employees 1,921 712 $7,122,400 $3,708 $180 0.00% 20 ­ 99 employees 3,469 1,286 $48,277,000 $13,917 $180 ­ $190 0.00% 100 ­ 249 employees 920 341 $50,976,600 $55,409 $168 ­ $190 0.00% 250 ­ 499 employees 350 130 $54,197,000 $154,849 $168 0.00% EXHIBIT 5­ 11 Distribution of Establishments in Petroleum Refining and Related Industries Classified as Small Businesses by Employment Size (SIC Code 29) Total Number of Estab. s (1992) Number of SPCCRegulated Facilities (1996) Total Revenue (Estab. s) ('000 dollars, 1992) Average Revenue per Estab. ('000 dollars, 1992) Cost of Revisions per SPCC­ Regulated Estab. (2001) %Impact per SPCCRegulated Estab. 1 ­ 4 employees 700 527 $913,600 $1,305 $180 ­ $190 0.01% 5 ­ 9 employees 442 333 $1,196,400 $2,707 $190 0.01% 10 ­ 19 employees 294 221 $1,349,400 $4,590 $190 0.00% 20 ­ 49 employees 317 239 $4,169,200 $13,152 $168 ­ $190 0.00% 50 ­ 99 employees 146 110 $4,914,500 $33,661 $168 0.00% 100 ­ 249 employees 123 93 $18,055,800 $146,795 $168 0.00% 250 ­ 499 employees 55 41 $46,949,811 $853,633 $168 0.00% 97 EXHIBIT 5­ 12 Distribution of Establishments in the Primary Metals Industry Classified as Small Businesses by Employment Size (SIC Code 33) Total Number of Estab. s (1992) Number of SPCCRegulated Facilities (1996) Total Revenue (Estab. s) ('000 dollars, 1992) Average Revenue per Estab. ('000 dollars, 1992) Cost of Revisions per SPCC­ Regulated Estab. (2001) %Impact per SPCCRegulated Estab. 1 ­ 4 employees 1,270 0 $622,488 $490 $0 0.00% 5 ­ 9 employees 760 102 $372,512 $490 $180 0.04% 10 ­ 49 employees 2,206 295 $7,566,500 $3,430 $180 ­ $190 0.01% 50 ­ 249 employees 1,685 225 $35,521,900 $21,081 $190 0.00% 250 ­ 499 employees 365 49 $26,767,200 $73,335 $190 0.00% EXHIBIT 5­ 13 Distribution of Other Establishments in the Manufacturing Industry Classified as Small Businesses by Employment Size (SIC Codes 20­ 39) Total Number of Estab. s (1992) Number of SPCCRegulated Facilities (1996) Total Revenue (Estab. s) ('000 dollars, 1992) Average Revenue per Estab. ('000 dollars, 1992) Cost of Revisions per SPCC­ Regulated Estab. (2001) %Impact per SPCCRegulated Estab. 1 ­ 4 employees 118,255 0 $21,291,512 $180 $0 0.00% 5 ­ 9 employees 60,021 4,404 $34,785,288 $580 $180 0.03% 10 ­ 249 employees 141,542 10,386 $742,914,200 $5,249 $180 ­ $190 0.00% 250 ­ 499 employees 6,111 448 $271,092,589 $44,361 $168 ­ $190 0.00% 98 EXHIBIT 5­ 14 Distribution of Firms in the Transportation Industry Classified as Small Businesses by Revenue Size (SIC Codes 411/ 413/ 414/ 417/ 42/ 449/ 458) Total Number of Firms (1992) Number of SPCCRegulated Facilities (1996) Total Revenue (Firms) ('000 dollars, 1992) Average Revenue per Firm ('000 dollars, 1992) Cost of Revisions per SPCCRegulated Firm (2001) %Impact per SPCCRegulated Firm Sales < $100,000 20,173 0 $1,209,005 $60 $0 0. 00% Sales $100,000 ­ $249,999 26,897 5,592 $4,391,119 $163 $180 0.11% Sales $250,000 ­ $499,999 18,581 3,863 $6,576,471 $354 $180 0.05% Sales $500,000 ­ $999,999 13,863 2,882 $9,709,760 $700 $180 ­ $190 0. 03% Sales $1,000,000 ­ $2,499,999 11,354 2,361 $17,602,357 $1,550 $190 0.01% Sales $2,500,000 ­ $4,999,999 4,595 955 $15,892,677 $3,459 $190 0.01% EXHIBIT 5­ 15 Distribution of Firms in the Pipeline Industry Classified as Small Businesses by Revenue Size (SIC Code 46) Total Number of Firms (1992) Number of SPCCRegulated Facilities (1996) Total Revenue (Firms) ('000 dollars, 1992) Average Revenue per Firm ('000 dollars, 1992) Cost of Revisions per SPCC­ Regulated Firm (2001) %Impact per SPCCRegulated Firm 0 ­ 9 employees 31 31 $150,888 $4,867 $180 0.00% 10 ­ 19 employees 10 10 $34,498 $3,450 $180 0.00% 20 ­ 49 employees 3 4 $24,166 $8,055 $240 0.00% 50 ­ 99 employees 10 38 $258,358 $25,836 $684 0.00% 100 ­ 249 employees 11 65 $433,023 $39,366 $1,064 0.00% 250 ­ 499 employees 6 84 $1,787,777 $297,963 $2,520 ­ $2,660 0.00% 500 ­ 999 employees 12 310 $3,230,336 $269,195 $4,340 ­ $4,908 0.00% 1,000 or more employees 3 58 $1,128,968 $376,323 $3,248 0.00% 99 EXHIBIT 5­ 16 Distribution of Electric Utilities Classified as Small Businesses by Revenue Size (SIC Code 4911) Total Number of Utilities (1992) Number of SPCCRegulated Facilities (1996) Total Revenue (Utilities) ('000 dollars, 1992) Average Revenue per Utility ('000 dollars, 1992) Cost of Revisions per SPCC­ Regulated Utility (2001) %Impact per SPCCRegulated Utility 0.0 ­ 0.1 million MWh 1,707 1,707 $4,229,382 $2,478 $180 0.01% 0.1 ­ 1.0 million MWh 1,145 1,145 $22,735,357 $19,856 $180 0.00% 1.0 ­ 4.0 million MWh 177 177 $17,848,257 $100,838 $180 0.00% EXHIBIT 5­ 17 Distribution of Firms in the Petroleum Bulk Station and Terminal Industry Classified as Small Businesses by Revenue Size (SIC Code 5171) Total Number of Firms (1992) Number of SPCCRegulated Facilities (1996) Total Revenue (Firms) ('000 dollars, 1992) Average Revenue per Firm ('000 dollars, 1992) Cost of Revisions per SPCC­ Regulated Firm (2001) %Impact per SPCCRegulated Firm 0 ­ 4 employees 2,429 2,429 $4,137,395 $1,703 $180 ­ $190 0.01% 5 ­ 9 employees 2,241 2,241 $11,092,383 $4,950 $190 0.00% 10 ­ 19 employees 1,765 1,765 $16,307,761 $9,240 $190 0.00% 20 ­ 49 employees 1,036 2,072 $20,842,729 $20,118 $380 0.00% 50 ­ 99 employees 284 568 $13,833,068 $48,708 $336 ­ $380 0.00% 100 EXHIBIT 5­ 18 Distribution of Firms in the Gasoline Service Station and Vehicle Rental Industries Classified as Small Businesses by Revenue Size (SIC Codes 554/ 751) Total Number of Firms (1992) Number of SPCCRegulated Facilities (1996) Total Revenue (Firms) ('000 dollars, 1992) Average Revenue per Firm ('000 dollars, 1992) Cost of Revisions per SPCCRegulated Firm (2001) %Impact per SPCCRegulated Firm Gasoline Service Stations Sales < $250,000 8,253 0 $1,184,947 $144 $0 0.00% Sales $250,000 ­ $499,999 9,358 2,437 $3,443,224 $368 $180 0.05% Sales $500,000 ­ $999,999 11,942 3,109 $8,683,722 $727 $180 ­ $190 0.03% Sales $1,000,000 ­ $2,499,999 17,286 4,501 $27,262,533 $1,577 $190 0.01% Sales $2,500,000 ­ $4,999,999 5,006 1,303 $16,794,841 $3,355 $190 0.01% Sales $5,000,000 ­ $6,499,999 433 113 $2,935,738 $6,782 $168 ­ $190 0.00% Vehicle Rental Sales < $100,000 893 0 $49,577 $56 $0 0.00% Sales $100,000 ­ $249,999 1,042 271 $172,145 $165 $180 0.11% Sales $250,000 ­ $499,999 872 227 $313,020 $359 $180 0.05% Sales $500,000 ­ $999,999 739 192 $510,392 $691 $180 ­ $190 0.03% Sales $1,000,000 ­ $2,499,999 668 174 $1,040,266 $1,557 $190 0.01% Sales $2,500,000 ­ $4,999,999 261 68 $912,764 $3,497 $190 0.00% Sales $5,000,000 ­ $9,999,999 170 44 $1,166,011 $6,859 $190 0.00% Sales $10,000,000 ­ $18,499,999 49 13 $727,354 $14,925 $168 ­ $190 0.00% 101 EXHIBIT 5­ 19 Distribution of Firms in the Fuel Oil Dealer Industry Classified as Small Businesses by Revenue Size (SIC Code 5983) Total Number of Firms (1992) Number of SPCCRegulated Facilities (1996) Total Revenue (Firms) ('000 dollars, 1992) Average Revenue per Firm ('000 dollars, 1992) Cost of Revisions per SPCCRegulated Firm (2001) %Impact per SPCCRegulated Firm Sales < $250,000 495 465 $72,499 $146 $180 0.11% Sales $250,000 ­ $499,999 679 637 $254,251 $374 $180 0.04% Sales $500,000 ­ $999,999 1,065 999 $775,040 $728 $180 ­ $190 0.02% Sales $1,000,000 ­ $2,499,999 1,211 1,136 $1,903,389 $1,572 $190 0.01% Sales $2,500,000 ­ $4,999,999 431 404 $1,447,285 $3,358 $190 0.01% Sales $5,000,000 ­ $8,999,999 138 130 $943,029 $6,814 $168 ­ $190 0.00% EXHIBIT 5­ 20 Distribution of Firms in the Health Care and Education Industries Classified as Small Businesses by Revenue Size (SIC Codes 801/ 802/ 803/ 804/ 805/ 806/ 807) Total Number of Firms (1992) Number of SPCCRegulated Facilities (1996) Total Revenue (Firms) ('000 dollars, 1992) Average Revenue per Firm ('000 dollars, 1992) Cost of Revisions per SPCCRegulated Firm (2001) %Impact per SPCCRegulated Firm Sales < $100,000 38,331 0 $2,450,771 $64 $0 0.00% Sales $100,000 ­ $249,999 112,109 1,692 $19,552,771 $174 $180 0.10% Sales $250,000 ­ $499,999 115,694 1,746 $40,932,245 $354 $180 0.05% Sales $500,000 ­ $999,999 63,069 952 $43,104,472 $683 $180 0.03% Sales $1,000,000 ­ $2,499,999 32,910 497 $49,866,711 $1,515 $180 ­ $190 0.01% Sales $2,500,000 ­ $4,999,999 10,621 160 $36,507,348 $3,437 $190 0.01% 102 EXHIBIT 5­ 21 Distribution of Other Commercial Firms Classified as Small Businesses by Revenue Size (SIC Codes 50­ 89, excluding SIC Codes 5171, 554, 5983, 751, and 801­ 807) Total Number of Firms (1992) Number of SPCCRegulated Facilities (1996) Total Revenue (Firms) ('000 dollars, 1992) Average Revenue per Firm ('000 dollars, 1992) Cost of Revisions per SPCCRegulated Firm (2001) %Impact per SPCCRegulated Firm Sales < $250,000 1,307,107 0 $152,478,332 $117 $0 0.00% Sales $250,000 ­ $499,999 505,076 14,824 $177,619,257 $352 $180 0.05% Sales $500,000 ­ $999,999 360,813 10,590 $250,677,354 $695 $180 0.03% Sales $1,000,000 ­ $2,499,999 266,512 7,822 $401,805,824 $1,508 $180 0.01% Sales $2,500,000 ­ $4,999,999 104,021 3,053 $348,644,995 $3,352 $180 0.00% 5. 4 CONCLUSION Overall, the Agency does not find the SPCC rulemaking revisions to cause a significant impact on a substantial number of small firms. Based on 1992 U. S. Census data and 2001 cost estimates for the revisions, the Agency did not find a significant economic impact on any single group of small businesses within any industry category identified as being subject to the SPCC program. In all cases the total cost of the revisions was estimated to be less than two­ tenths of one percent of the revenue of the firm.

epa

2024-06-07T20:31:41.370845

regulations

EPA-HQ-OPA-1997-0002-0073

Supporting & Related Material

SPCC­ 7­ 7­ 19 OPA­ 1997­ 0002­ 0073 PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503. 1. Agency/ Subagency originating request OSWER 2. OMB control number b. G None a. 205 0 ­ 0135 __ __ __ __ 3. Type of information collection (check one) a. G New collection b. X Revision of a currently approved collection c. G Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested (check one) a. X Regular b. G Emergency ­ Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b­ f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___ 7. Title Oil Pollution Act Facility Response Plans ­ 40 CFR Part 112.20 8. Agency form number( s) (If applicable) 1630.07 9. Keywords Oil, oil spill, prevention 10. Abstract This ICR would renew the current ICR for the Facility Response Plan (FRP) regulation, 40 CFR part 112, for non­ transportation­ related facilities that handle, store, or transport oils. The FRP rule which was promulgated under section 311( j) of the Clean Water Act, as amended by OPA, applies only to high risk facilities that transfer large volumes of oil over water, or store one million gallons or more of oil, and meet additional criteria. This ICR includes EPA ICR 1630.06, which applies to facilities that handle, store, or transport animal fats or vegetable oils, which has been previously approved by OMB. 11. Affected public (Mark primary with "P" and all others that apply with "X") a. Individuals or households d. X Farms b. X Business or other for­ profit e. Federal Government c. Not­ for­ profit institutions f. State, Local or Tribal Government 12. Obligation to respond (Mark primary with "P" and all others that apply with "X") a. G Voluntary b. G Required to obtain or retain benefits c. X Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 10,310 b. Total annual responses 10,310 1. Percentage of these responses collected electronically % c. Total hours requested 583,130 d. Current OMB inventory 562,534 e. Difference 20,596 f. Explanation of difference 1. Program Change ­280 2. Adjustment 20,876 14. Annual reporting and recordkeeping cost burden (in thousands of dollars) a. Total annualized capital/ startup costs $ 22 b. Total annual costs (O& M) $ 0 c. Total annualized cost requested $ 22 d. Current OMB inventory $ 20 e. Difference $ 2 f. Explanation of difference 1. Program change $ 0 2. Adjustment $ 2 15. Purpose of information collection (Mark Primary With "P" and all others that apply with "X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. _P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting (check all that apply) a. Q Recordkeeping b. Q Third party disclosure c. Q Reporting 1. X On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi­ annually 6. Q Annually 7. Q Biannually 8. Q Other (describe) 17. Statistical methods Does this information collection employ statistical methods? Q Yes X No 18. Agency contact (person who can best answer questions regarding the content of this submission) Name: Barbara Davis Phone: 703­ 603­ 8823 OMB 83­ I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9. NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions. The following is a summary of the topics, regarding the proposed collection of information, that the certification covers: (a) It is necessary for the proper performance of agency functions; (b) It avoids unnecessary duplication; (c) It reduces burden on small entities; (d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents; (e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices; (f) It indicates the retention periods for recordkeeping requirements; (g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): (I) Why the information is being collected' (ii) Use of information; (iii) Burden estimate; (iv) Nature of response (voluntary, required for a benefit, or mandatory); (v) Nature and extent of confidentiality; and (vi) Need to display currently valid OMB control number; (h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected (see note in Item 19 of the instructions); (I) It uses effective and efficient statistical survey methodology; and (j) It makes appropriate use of information technology. If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement. Signature of Program Official Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83­ I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads "As part of the agency submission to OMB of a proposed collection of information, the agency (through the head of the agency, the Senior Official or their designee) shall certify (and provide a record supporting such certification) that the proposed collection of information "( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility; "( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency; "( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as: "( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof; "( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond; "( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond; "( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified; "( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [see below] "( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public; "( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public." NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information: "( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection (together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit (citing authority), or mandatory (citing authority); "( v) the nature and extent of confidentiality to be provided, if any (citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number." OMB 83­ I (Instructions) 10/ 95

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EPA-HQ-OPA-1997-0002-0075

Supporting & Related Material

SPCC­ 7­ 7­ 21 OPA­ 1997­ 0002­ 0075 PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503. 1. Agency/ Subagency originating request Office of Emergency and Remedial Response, Office of Solid Waste and Emergency Response, U. S. Environmental Protection Agency 2. OMB control number b. G None a. 2050 ­ 0021 3. Type of information collection (check one) a. G New collection b. G Revision of a currently approved collection c.
Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested (check one) a.
Regular b. G Emergency ­ Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes
No For b­ f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a.
Three years from approval date b. G Other Specify: / /__ 7. Title Spill Prevention, Control and Countermeasures (SPCC) Plans 8. Agency form number( s) (If applicable) 0328.08 9. Keywords Oil, oil spill 10. Abstract The Oil Pollution Prevention regulation requires certain regulated facilities to prepare and maintain SPCC Plans in order to prevent oil discharges. 11. Affected public (Mark primary with "P" and all others that apply with "X") a. Individuals or households d.
Farms b.
Business or other for­ profit e.
Federal Government c.
Not­ for­ profit institutions f.
State, Local or Tribal Government 12. Obligation to respond (Mark primary with "P" and all others that apply with "X") a. G Voluntary b. G Required to obtain or retain benefits c.
Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 469,289 b. Total annual responses 469,993 1. Percentage of these responses collected electronically 0 % c. Total hours requested 2,828,150 d. Current OMB inventory 2,766,821 e. Difference 61,329 f. Explanation of difference 1. Program Change 0 2. Adjustment 61,329 14. Annual reporting and recordkeeping cost burden (in thousands of dollars) a. Total annualized capital/ startup costs $316 b. Total annual costs (O& M) $28,427 c. Total annualized cost requested $28,743 d. Current OMB inventory $305 e. Difference $28,438 f. Explanation of difference 1. Program change 0 2. Adjustment $28,438 15. Purpose of information collection (Mark Primary With "P" and all others that apply with "X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g.
Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting (check all that apply) a.
Recordkeeping b. Q Third party disclosure c.
Reporting 1.
On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi­ annually 6. Q Annually 7. Q Biannually 8. Q Other (describe) 17. Statistical methods Does this information collection employ statistical methods? Q Yes
No 18. Agency contact (person who can best answer questions regarding the content of this submission) Name: Hugo Fleischman Phone: 703­ 603­ 8769 OMB 83­ I 10/ 95

epa

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regulations

EPA-HQ-OPP-2002-0002-0004

Supporting & Related Material

, STUDYTITLE DATA REVPEW IN SUPPORT OF THE REQUEST FOR TEE E­? UUWE" PPON OF METHYL ANTHRANILATE FROM THE REQUWEMENTS OF .A TOLERANCE ON ALL RAW AGRICULTUERAL COMMODITIES DATA REQUIREMENTS Food Quality Protection Act. AUTBOR Leonard R. Askham, PbD. REVIEW COMPLETED ON April 2, 1992 SUBMITTOR Bird Shield Repellent Corporation P. O. Box 785 Pullman, WA 99163 , I' STATEMENT OF DATA CONFIDENTIALITY CLAMS No claim of confidentiality is made for any information contained in this study on the basis of its falling within the scope of FIFRA lO( d)( l)( A), @) or (C) Submitter: ' Bird Shield Repellent Corporation Submitting Agent:& eonard R Askham, PhD. Date 6 3 GOOD LABORATORY PRACTICE STATEMENT Bird Shield Repellent ­ EPA Reg. No. 66550­ 1 L This submission does not fall within the requirements of 40 CFR Part 160 / .. .. .. TITLE Product Identity and Composition 1. Product Identity and Composition 2. MerckIndex 3. Registry of Toxic Effects of Chemical Substances Biological Derivation of Methyl Anthranilate 1. 2. 3. 4. Methyl Anthranilate Content of Ohio Concord Grapes Concord Wine Composition as Affected by hditurity and Processing Technique The Odor Quality of Labrusca Grapes An Investigation of the Volatile Flavor Composition of Vitus Labrusca Grape Musts and Wines. I. Methyl Anthranilate ­ Its Role in the Total Aroma'Picture ofLabrusca Varieties Isolation and Identification of Volatiles from Catawba Wine Methyl Anthranilate as an Aroma constituent of American Wine. Inheritance of Methyl Anthranilate and Total Volatile Esters in yi& SPP­ Red Wine Aroma: Identification of Headspace Constituents SECTION Tab. A' Tab. B US/ FDA Registration of Methyl Anthranilate asaGenerallyRecognized as Safe( GRAS) CompoundTab. C 1. 21 CFR 182.60 ­ Synthetic Flavoring Substances and Adjuvants; 2. 2 1 CFR 184.102 1 Benzoic Acid Methyl Anthranilate Methyl Anthranilate as a Flavor and Perfume Ingredient 1 .. Fenaroli's Handbook Qf Flavor Ingredients, Second Edition, Volume 2 2. Perfume Synthetics and Isolates U. S. Department of Commerce Scientific Literature Review of Anthanilates in Flavor Usage. Vol. 1. Introduction and Summary Tables of Data, Bibliography Tab. D Tab. ­E. 1. Toxicity to Mouse, Rate and Guinea Pig 2. Chemical Identity and Physical Properties 3. Pharmacological and Toxicological Effects 4. NaturalOccurrence 5. Flavor and Extract Manufacturers' Association (FEMA) and 5. Addendum to Table IV­ 2 7. Bibliography 8. DataGuide National Academy of Science WAS) Use Levels. AcuteToxicityforMice, Hamsters, Birdsand Fish Tab., F 1 ­ Food Fiavoring and Compounds of Related Structure. I. 2. Acute Oral Toxicity and Repellency of 933 Chemicals to 3. Studies of Drug Adsorption from Oral Cavity: Physio­ Acute Oral Toxicity House and Deer Mice. chemical Factors AEecting Absorption from Hamster Cheek Pouch. 998 Chemicals to One or More Species of Wild and Domestic Birds. 5 . Comparison of Fish Toxicity Screening Data and QSAR Predictions for 48 Aniline Derivatives. 4. The Acute Oral Toxicity, Repellency and Hazard Potential of (@ T TAB A. PRODUCT IDENTITY AND COMPOSITION TABLE OF CONTENTS \.%/ ' 1 . Product Identity, and Composition 2. The MerckIndex 3. Material SafetyData Sheet 4, Registry of Toxic Effects of ChemicalSubstances, Volume 1 (c) Additional. informtion on iqredient~ (i) a~ chanical name is methyl arrthranilate othersvnorrvms: Anthranilic acid, methyl ester Mew1 2­ amhdIemoate Methyl o­ aminobenzoa~ 2­ AminabenZoic acid m y 1 ester (ii) CPS Resistry NLmJser: . 134­ 20­ 3 (1985­ 1986) {iii) StmAud. Forrnrla (i) Methyl an­ ate is mined synthetically by . . present# of sulfuric acid (see pspenaix 1). (ii) Fonnilatim of BIRD SKIELD (Refer to i0nfidmtia. l state­ esterifying anthmdlic add w i t h methyl alcdbol­ in the ment of fonuila, fonn 8570­ 4, Confidmtial Attadrment, CnxS F& fer? mce 1). \ ! i. i I THE MERCK INDEX AN ENCYCLOPEDIA OF CHEMICALS, DRUGS, AND BIOLOGICALS ELEVENTH EDITION Susan Budavari, Editor Maryadele J. O'Neil, Associate Editor Ann Smith, Assistant Ediror Patricia E. Heckelman, Editorial Assistant Published by MERCK. & CO., INC. R A H W A Y , N .J .. U .S .A . 1989 I 17.96% H 12.08% iN 18.65%. 0 21.30%. CH, NHCH,­ >H, OH. f h e in vivo precursor of choline. Has been isolated 'rom a mutant of Neurospora c m s n which has lost its ability o synthesize choline: Horowitz. J. Bioi Chem. 162, 413 '1946). Prepd by mixing ethylene oxide with concd methyl­ mine soh with external cooling: Knorr. Matthes. Ber. 31, 1069 (1898); Lowe ct 02.. Brit. pat. 763,434 (1956 to Oxirane Ltd.); Nikolaev et al., Zh. qbshch. Khim. 33, 391 (1963). Viscous liquid. Fishy odor. dm 0.937. bp, 60 155­ 156"; >p12 64­ 659 n$ 1.4385. Miscible with water. alcohol, ether. Zorrosive to skin, cork, metals. Strong base. Forms a deli­ xuescent salt with HCI. LD, orally in rats: 2.34 glkg, Toxic Substances Lisr. H. E. Christensen, Ed. (1974) p 339. Picrate, yellow crystals, mp 148­ 150". Caurion: Irritating to skin, eyes, mucous membranes. minophenol sulfate; p­ hydroxymethylaniline sulfate; Pho­ 5940. p­ Methylaminophenol Sulfate. Monomethyl ­p­ :ol; Verol; Rhodol; Armol; Elon: Genol; Graphol; Photo­ Rex: Pictol; Planetol; Metol. C,, H, N, O, S: mol wt344.38. :HOC6H, NHCHJ2. H2SO,. Sol in 20 parts cold, 6 parts boiling water; slightly sol in alc; Crystals. Discolors in air. mp about 260' with decompn. nsol in ether. Keep well closed and protected from light. C 48.82%, H 5.85%. N 8.14%. 0 27.87%, S 9.31%. USE: Photographic developer, dyeing Furs. vlaniline. C, H, N: mol wt107.15. C 78.46%. H 8.47%. N 5941. Methylaniline. ~­~ e~ hglbenze~ ramine: rnonomerh­ 13.07%. C, H, NHCHJ. Made by heating aniline chloride and methyl alcohol under pressure. exposure to air. d p 0.989. mp ­5579 bp 194­ 196'. nZ1J Colorless or slightly yellow liquid; becomes brown on 1.5702. Slightly sol in water; sol in alc, ether. LD orally% rabbits: 280 mglkg. esrer; methyl 2­ aminobenzoate; neroli oil, artificial. C, H,­ 5942. Methyl Anthranilate. 2­ Aminobenzoic acid mefhyl NO,; mol wt 151.16. C 63.56%. H 6.00% N 9.27%, 0 other essential oils and in grape juice: also obtained syn­ 21.17%. Occurs in neroli. ylang­ ylang. bergamot, jasmine, thetically by esterifying anthranilic acid with CH, OH in presence of HCI. water: freely sol in alcohol or ether. LD, orally in rats. Crystals. d 1.168, mp 24­ 259 bpIs 135.59 Slightly sol in mice: 2910. 3900 mglkg, P. M. Jenner et al.. Fwd Cosmer. . Toxicol. 2, 327 (1964). CSEl As perfume for ointments: manuf synthetic perfumes. cenediono; 8­ methylanthraquinone. C,, H,, O$ mol wt 5943. 2­ h­ lethylanthraquinone. 2­. MelhpI­ 9, f 0­ ahthro­ 222.23. C 81.06%. H 4.54% 0 14.40%. Occurs in teak­ wood. Prepd by oxidation of 2­ methylanthracene; by for­ Syn 4, 43 (1925); from 6­ and 7­ methylanthraquinone­ l­ mation from phthalic anhydride and toluene: Fieser. 0%. carboxylic acids with powdered copper in quinoline: Fiescr. Martin. J. Am. Chem. Soc. 58. 1443 (1436); from 1.4­ naph­ thoquinone and isoprene: Carothers. Berchet, ibid. 55. 2813 (1933). Needles from alcohol, mp 177". Sublimes. Very sol in benzene, toluene. xylene; sol in alcohol, ether. glacial acetic acid. concd H, SO,; insol in water. noside; methylarbutoside. C, H, O,; mol wt286.28. C 5944. Methytarbutin. 4­ Melhox~ phengl­~­ D­~ lucopyra­ 54.54%, H 6.347' 0 39.12%. Occurs together with arbutin I~ " HANUFACNREB WHEATEC ' I : ' mD& ss: 2 S. 076 0rchard" Rd. ,, Wheaton, IL 60187 EMERGENCY TELEPHONE: 708­ 682­ 3024 I _. Hethyl Anthranilate CBEHICdL NAXE AND SYNONYMS: Methyl 2 ­ Aminobenzoate * TRADE NAME AND SYNONYMS: HETHYL ANTHRANILATE, HA ­ FCC CHpfIcILL FAKILY: Aromatic Acid Ester FOWLA: C8H9N02' 6 4 2 2 . C H NH CO H CAS REGISTRY NUHBER: 134­ 20­ 3 DOT SHIPPZHC CLASSIFICATION: Cherni­. lc , NO1 PBODUCT NUMBER: .. * .. S E C T I O N 11 . HAZARDOUS INGREDIENTS M T E R U L : .* Methyl 99+ TLV (Units) SECTION 111 . PHYSICAL DATA ­ r" ik." d ­ ,i \? " ..­ ,: BOILING POINT, 76­ e Xg: 206OC 6 FREEZING POINT : 24 *c SPECIFIC CBAVITY: 1.165 VAPOR PRESSURE AT .2OoC. : < lmm Hg VAPOR DENSITY (Air ­ 1): No Data Found SOLUBILITY IN WATER: Approximately. O. 1% X VOLATI& ES BY VOLUME: 0.5% max. a s w a t e r ]E; VAPORILTION RATE : No Data Found * * APPEARANCE AND ODOR: Colorless t o pale y e l l o w l i q u i d vith a b l u i s h fluorescence, o r w h i t e c r y s t a l s a t room temp. .­ I .I".. .­ . . ...*. ­ ­ ­ .­ *. Crape like' odor '. .. .. . . " .. CTION XV. ­­ FIRE AND EXPLOSION­ WARD DATA FLASH POINT: . 212'F (CC) FLAHHABLE LIMITS I N AIR: No Data Found EXTINGUISHING' HEDIA: Carbon Dioxide Dry Chemical, Foam. SPECIAL FIRE FICXTING PROCEDURES:, F u l l p r o t e c t i v e e q u i p m e n t i n c l u d i n g s e l f ­c o n t a i n e d breaching apparatus should be used. Uater spray'may be i n e f f e c t i v e . If water 1s used, fog nozzels are;,$. referable. Water may be used t o c o o l c l o s e d c o a t a i n e t r t o p r e v e n t p r e s s u r e b u i l d ­u p .a n a p o s s i b l e a u t o i g n i t i o n or explosion when ­exposed to ­0 . AUTOIGNITION TEMPERATURE: No. Data Found .. extreme heat. E' .:+ n. uN" suaL FIRE AND \$ \ \­+ J EXPLOSION w s ; +Closed containers may explode (due t o the build­ up of '& ,4 ., '\ I Pressure) wh? n'@ XpOSed t o extreme heat. >. I 1 .. THRESHOLD LIMIT VALUE: None Assigned EFFECTS OF OVEREwosu~~: E x c e s s i v e e x p o s u r e m y c a u s e s k i n a n d eye i r r a t a t i o n . Other t o x i c e f f e c t s a r e unknown. Methyl a n t h r a n i l a t e is included i n t h e GKAS (Generally recognized as s a f e ) l i s t .. E m ~G m c y AND FIRST AXD PROCEDURES: I F INHALED: If a f f e c t e d , remove. from e x p o s u r e . R e s t o r e b r e a t h i n g . Keep warm and q u i e t . I F ON SKIN: Wash affected a r e a t h o r o u g h l y w i t h s o a p a, nd water. I F IN EYES: F l u s h e y e s w f t h large amounts of water for 15 minutes. Get medical a t t e n t i o n . IF SWALLOWED: Never give anything by mouth t o a n u n c o n s c i o u s p e r s o n . G i v e s e v e r a l g l a s s e s o f water. If vomiting is not spontaneous, induce vomiting by g e n t l y t o u c h i n g t h e back of t h e p a t i e n t s t h r o a t w i t h a f i n g e r . Keep a i r w a y c l e a n . S e e k q e d i c a l a t t e n t i o n . TOXICITY Oral LDSu (. Rat) 3,000 ­ 5,000 mg/ kg. c SECTION .VI. REACTIVITY DATA. .­ I ­ STABILITY: Stable WCOHPATIBILITY: O x i d i z i n g ., HAZARDOUS DECOHPOSITION PRODUCTS: BY FIKE: Carbon Dioxide, Carbon Monoxide ,. and Oxides of Nitrogen. HAZARDOUS POLYMERIZATION: Will Not Occur. _. . .. ~ .­ SECTION­ VI1 SPILL OR LEAK PROCEDURES ..: " STEPS TO BETAKEN IN CASE THEMATERIAL IS SPILLED OR RELEBEP: ' S p i l l e d material can be c o l l e c t e d a n d h e l d for reclaim or placed in a cov'ered waste disposal c o n t a i n e r . WASTE DISPOSAL .METHOD: S a n ­i t a t y l a n d f i l l or i n c i n e r a t e Cr, a p p r o v e d f a c i l i t y . Do not i n c i n e r a t e c l o s e d c o n t a i n e r . Dispose of In accordance with Federal, State , .a n d L o c a l r e g u l a t i o n s r e g a r d i n g p o l l u t i o n . ' ~­­­ I­"". rrPT SECTION "".­ V I I I a E C T A L .. PR! XE­ NJSS% Z$ SN RESPIRATORY PROTECTION: Use a r e s p i r a t o r a p p r o v e d for organic vapors, fumes and mists i n areas laden wtth vapor. VENTILATION: L o c a l e x h a u s t p r e f e r a b l e ,. g e n e r a l e x h a u s t a c c e p t a b l e . . . PROTECTIVE GLOVES: R e q u i r e d f o r l o n g or repeated contact. EYE PROTECTION: Wear s a f e t y s p e c t a c l e s w i t h unperforated. sideshield6. OTHERPROTECTIVEEQUIPMENT: Eye wash, Safety shower, \ .. . SECTION IX . SPECIAL PRECAUTIONS 1 PRECAUTIONS TO BETAKEN IN HANDLING AND STORAGE: .Do not store neer open flames or o x i d i z i n g a g e n t s . Avoid stor€ ng i n high t e m p e r a t u r e a r e a s r OTHERPRECAUTIONS: Avoid excessive exposure: Do n o t t a k e i n t e r n a l l y . REVISED: June 17, 1988 SUPEBCEDES: July 20, 1984 .. ,_ .. ., .. ~MEIHYLANIHRANIIATE" safety data for =thy1 anthranilab summarized in the follwjng reference bo&: ­in mishy of Toxic Eff­ O f chemical substances R e g i s t r y of Toxic Effects of chdm substances edited by R. L. Tatken and R. J. Lewis, Sr. 1981­ 82 edition. U. S. Dept. of Health and Human Services, Public Health service Centers for Disease Control, National Institute for Occupational Safety and fiealth, Cincinnati, OH 45226 me above ref­ lists the following toxicity data: mth~ l ­late CAS RN: 134­ 20­ 3 Skin Irritation ­ ­it 500 mz/ 24 hours: Merate Q t Edited by Rodger L. Tatken and Richard J. Lewis, Sr. US. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Centers for Disease Control National Institute for Occupational Safety and Health Cincinnati, Ohio 45226 June 1983 .. Cnnu b34.71 " " RATAW hU# ". WECS U6UOGRAPHIC REFERENCES 1981­ 82 M?? w 1. 2. 3. 4. 5. 6 . 7. 8. Methyl anthranilate Content of Ohio Concord Grapes. Concord Wine Composition as Affected by Maturity and Processing The Odm Quality of Labrusca Grapes. An Investigation of the Volatile Flavor Composition of Vitus Technique. Labrusca Grape Musts and Wines. I. Methyl Anthranilate ­ Its Role in the Total Aroma Picture of Labrusca. Varieties. Isolation and Identification of Volatiles &om Catawba Wine Methyl anthranilate as an Aroma Constituent of American Wine. Inheritance of Methyl anthranilate and Total Volatile Esters in Red Wine Aroma: Identification of Headspace Constituents. ­ vitis spp. a" . .. ' A Research Note Methyl Anthranilate Content of Ohio Concord Grapes JIM­ WEN R. LIU and JAMES F. GALLANDER ABSTRACT Concordgrapesgrown at five locations in Ohiowerecollected in 1982 and 1983 for analysis of methyl anthranilate (MA) in frearun and heat­ extracted juice samples. The hiA content of freerun juice ranged from 0.33­ 2.05 mg/ L in 1982 and 0.14­ 0.91 mg/ L in 1983. The MA content was higher in heat­ extracted juice than in frearun juice. Heat­ extracted juice contained 0.19­ 2.60 mdL of MA in 1982 and 0.22­ 3.50 mg/ L in 1983. In general, the MA content in­ creased with maturity and was highest in grapes grown in the cool­ est regions. INTRODUCTION METHYL ANTHRANILATE (MA), the methyl ester of o­ aminobenzoic acid, is one of the several compounds which contribute to the characteristic aroma of Concord grapes, This compound was used in synthetic grape­ flavored products before it was found in grapes (Acree, 1981). The measurement of MA. provides basic information for the con­ trol of flavor quality of Concord grapes and its products. There are several methods available for the determination of MA. These include a colorimetric procedure (AOAC, 1980), a g a s chromatographic procedure (Mattick et al., 1963), and a fluorometric method (Casimir et al., 1976). Robinson et aL (1949) reported that MA of New York Concords developed mainly ih the last stage of maturation and. declined slightly when fruits became overmature. Clore et al. (1965) and Fuleki (1972) obtained similar results with Washington and Ontario Concords, respectively. Clore e t al. (1965) also reported that season, pruning, vineyard location, and type of soil could affect MA content of Corn­ cord grapes. In Ohio, about 72% of the present acreage is planted t o the Concord cultivar (Cahoon, 1984). Approximately 97% of the Concord crop in Ohio is used for processing. The purpose of this study was to determine the MA content of Ohio Concord grapes as influenced by season, vineyard location, and maturation. MATERIALS & METHODS Sample collection Fruit samples were collected in the 1982 and 1983 seasons from five different vineyard locations in Ohio. Ai each location 10 vines were selected for harvest a t three different levels of maturity. me fust level of maturity was chosen as the time when all berries had completedcolorchange( post­ veraison). Thesecondandthird maturity wereabout 1­ 2 and 2­ 4 wk, respectively, afterthe first sampling. The grapes were harvested a t increments of approximately 2'Brix when possible. For each maturity. two berries were randomly taken from each of the middle 20 clusters, located in the upper portion of the fine. The berries from the 10 vines were pooled, and a total of 400 benies Were collected for each replicate. Duplicated samples were kept in plastic containers and stored overnight at 4° C. Authors Liu and Gallander are affiliated with the Dept o f Horticul­ ture. Ohio Agricultural Research & Development Center, The Ohio state Univ., Wooster. OH 446993. 280­ JOURNAL OF FOOD SCIENCE­ Volume 50 (1985) Sample preparation Berries (100) from­ eachreplicatewerepassedthrough, press (Squeezo strainer) to obtain free­ run juice. Approha mL free­ run juice was centiifuged on an IEC­ 140 rotor at mately 900 x g for 10 min to remove gross particles. natant was analyzed for soluble solids (" Brix) with a refrac Thejuice was then stored in glass containers at ­17° C u analysis could be performed. Heat extracted juice was prepared by macerating appr 200g of berries in a Waring Blendor at low speed for 1% macerate was placed in a 250 mLbeaker, covered with glass, andheated in a water bath at 85° Cfor 1 hr. macerate was cooled to 40° C and drained through cheesecl heat­ extracted juice was then centrifuged as described for run juice and the supernatant was decanted and stored at glass containers The frozen juice samples of both freerun and heat e x n a thawed and brought to room temperature prior to analyk fa Analysis of MA The fluorometric procedure of Casimir et d (1976) was the determination of MA. A 10 mL sample of grape juice wa distilled in a Cash distillation assembly (Research and Devel Products, Berkeley, CA) rather than in a micro­ Kjeldahl app as described by Casimir et aL (1976). Preliminary experiments indicated that in order to use the assembly for steam distillation, a slight modification on the p dure of Casimir et aL (1976) wasnecessary to obtain more 96.0% recovery of MA. Approximately 76 mL of distillate lected in 8 min in a 100 mL volumetric flask containing 20 m pH 7 buffer. Thebufferwaspreparedaccording to Carimj (1976). The collected distillate was brought to vo1um. e wilh distilled water. The temperature of the distillate was kept at 1° C. Thefluorescence of the distillate was then measured Model J4­ 7439 Fluoro­ colorimeter( AmericanInstrumen SilverSprings, MD) equippedwith a primaryfilter (pea mission at 360 nm) and a. secondary filter (at 415 nmand The fluorometer was calibrated with standard solutio anthranilate. The standard eqor of the mean of three M A ?O. OlQ mg/ L for a grape juice samplecontaining 1 with a tom1 of 300 mLglass­ distilled water. The Cash assemblywasflushedbetweensamples three RESULTS & DISCUSSION RESULTS indicated that there was a large variation in content between two replicated juice samples. For exa the MA content of heat­ extracted juice collected a on 9/ 9/ 82 was 0.75 2 0.40 mg/ L, and the MA c free­ run from Wooster on 9/ 14/ 83 was 0.23 k (Tables 1 and 2). Fuieki (1972) reported that cons1 variability was observed when juice t o be analyzed was tained by pressing the grapes. To reduce variability, he ommended the use of whole grapes instead ofjuice steam distillation. 2.05 mg! L in 1982 and O714­ O. 9i mg/ L in 1983. For extracted juice, MA content varied from 0.19­ 2.60 mgi 1982 and 0.22 to 3.50 mg/ L in 1983. In general, heat traction increased MA coritent in the juice. Rice (1975) ported that hot­ pressed ,,(= oncord juice contained mu higher MA than did cold:$ ressed juice. Clore et d (196 analyzed the MA content rjf Washington Concords. fhe M The MA content of free­ run juice ranged from 0.3 . 8 . z* 2753 9t7 13.9 ! S­ IA 2948 911 5 15.7 0.77 2 0.09 1.16 t 0.06 OB5 t 0.02 0.72 t 0.03 23 18 a m 2424 9/ 7 2593 9/ 15 12.4 0.67 2 0.05 1.00 i 0.12 14.5 1.13 f 0.06 15.2 1.34 i 0.16 0.93 t 0.08 1.02 i 0.20 0.33 t 0.04 0.19 3 0.02 0.69 t 0.02 0.75 3 0.4Q . 15.6 1.76 t 0.04 2.22 2 0.60 0.91 2 0.05 0.00 f 0.12 1.87 t 0.12 0.54 t.­ o. oa 1891 8130 11.7 201 2 919 21 92 9/ 28 2183 911 14.2 2372 911 3 2479 9/ 23 15.1 1.66 t 0.04 15.9 2.05 2 0.20 2087 9t9 14.0 0.70 +­ 0.12 13.4 1.52 t 0.18 .~ 11BC 0.42 3 O. 0Zd 0.55 * 0.01 2272 9123 15.0 " ­ 1.55 i 0.33 2.60 t 0.05 2414 1015 17.4 1.34 2 0.01 1.63 3 0.03 . of degrees above 50° F within the state from ­ April to the date of harvest; 1. c.. X: t( dally ~~ maxlmum­ daily mlnlmum)/ 2­ 50]. *~y f duplicate F #* , dup{ icates t­ standard error of mean f " Degree Date Soluble s { of solids MA content (rng/ L) wm'vd #: ion daysb harvest P ~r i x ) Free­ run Heat­ extract 2836 911 12.6' . 0.17 f 0. Old 3133 0.28 i 0.00 3299 9/ 21 .16.4. 0.18 t 0.06 0.48 f 0.00 0.22 t­ 0.01 2552 916 271 9 911 4 13.7 0.14 2 0.02 0.42 i 0.1 3 15.1 0.22 +­ 0.04 912 1 0.62 i 0.06 16.3 0.30 : 0.02 0.70 3 0.02 2214 916 14.6 0.23.2 0.08 911 4 089 t­ 0­ 01 17.0 2448 912 1 18.1 0.41 t 0.13 1.69 t 0.05 0.63 k 0.1 81.90 t 0.1 0 2507 917 14.1 2668 0.28 t 0.02 *I 911 5 0.74 i 0.02 15.7 279 1 9/ 22 OS1 i 0.06 1.97 t 0.03 034 t 0.09 0.44 f 0.04 056 t­ 0.01 1.70 t 0.14 0.91 t­ 0.06 350 i 0.1 0 ,I 9/ 12, 14.9 0.16 i 0.02 .. cpcs3 2840 antral) 2352 "­ 1 16.1 0.70 i 0.05 232 +­ 0.12 E 2377 9/ 8 129 2555 9/ 19 155 2624 9/ 27 16.6 r of degrees above 50'F region wltnin the state from April to the date of harvest; Le., Z[ (aally cIU­ of duplicate & O! duplicate f standard error of mean c 5 m e a t for the whole grape, skin, pulp. juice drained from central Ohio vineyards (Morrow and Columbus) tended to i. w. and juice drained from skins was 6.0, 5.8, 1.8, 2.2 be lower than those from northern Ohio (Wooster, San­ @ Zd ppm, respectively. They concluded that most of the dusky, and Madison) at comparable levels of maturity. :. w h y 1 anthranilate was, located in the skin fraction. Clore et a1 (1965) reported the effect. of vineyard location fr. gcneral, the MA content increased with maturity. This on MA content, but noticed that soil type, pruning severity, P m weement with the findings of other researchers (Rob­ and solar radiation could also influence MA content. Based t t at.. 1949; Clore et al., 1965; Flueki, 1972). Robin­ an the total number of degree days, the MA content seemed a t t al. (1949) reported that MA content of New York to be related to the regional climate. Grapes from colder PrRn .. Concords increased during ripening and decreased regions contained higher concentrations of MA. The MA . ftlt when the fruit became overmature. However, Clore content in 1983 was generally lower than that of 19S2. 4 @ d (1965) found that MA content did not necessarily This was apparently due to a warmerseason in 1983. ; k­ bQnc when grapes became ' overmature. In this study, were some decreases in MA contrni in 1982 from the ­c m a t u r i t f t o t h e t h i r d m a t u r i t y f o r grapes from the REFERENCES '* 4mk and Madison vineyards. Whether this Kas due to . A ~~~, T. E. 1981. The odor quty ofi& rusca =apes. ACS s Y m p ~ m i n a t i o n of MA beyond the third maturity. No de­ AOAC. 1980. "Official Methods of Andy&" 13th e a Association 1 ­ in MA content was observed for samples collected in ' Cahoon. G. A. 1984. Private communication. Horticulture Dept. i.: m 3 *ason. Ohio Agriculturd Research 6 Development Center. Ohio State 'k MA content of Concord grapes from southern and ', ... . casimir. D. 3.. Moyer, J. c­, md Mattick. L. R. 1976. Fluorometric % Univ.. Wooster. OH. Volume 50 IISBSI­ JOURNAL OF .FOOD SCIENCE­ 281 Pa &coming overmature is not clear, since there was no sium Series 170: 11. of Official Analytical Chemists. U'ashington, DC. .. determination of methyl anthranilate In Concord grape juict. Daw varietier Ch. 4 In "Chemistry of Winem" JAOAC 69: 269. Clore, W. J., Neubert. A. M., Carter: G. H.. Ingalsbe. D. W.. and Bmm­ Robinson. W. B.. Shaulis. N. J.. and Pederson. C. S. 19 mund. V. P. 1965. Composition of U'ashington­ uro& aced Concord studies of grapes grown for juice manufactum. F m pap­ .nd juices. Wash. Agr. ESP. Sta. Tech. Bull. 482 96. papes grown io Ontdo during ripening in the 1970 season. Can. J. Plant ScL 52: 863. Matti4 L. R.. Robinson. W. B.. Weirs, L. D., and Barry. D. L. 1963. Determination of methyl anthranilate in grape juice by electron Rim. A. C. 1975. Chemistry of a­ inemaking from native American dfinfty­ gas Chromatography. 1. Amic. Food Chem. 11: 334. Webb. P. 88. Am. C h c a SOC. Adv. Chem, Sex. 197. . a F d e a T. 1972. Changes in the chemical composition of Concord Ma received 7/ 13/ 84; accepted 8[ 27/ 84. .­ :* KINETICS OF WATER UPTAKE BY FOOD PRODUCTS.. . From page 279 REFERENCES Baumann. €I. 1966. Apparatur nach Baumann Zur bestimmung der Anstrichm. 68( 9): 741. flussigkeit soufnahme von pulnigen substanzen. Fette, Seifen, Gerschenson. L. N.. Boquet. R.. and Bartholomai. G. B. 1983. Ef­ fect of thermal treatments on the moisture sorption isotherms tinurn L.). Lebensm.­ Wiss. u. Technol. 16: 43. of protein isolate. starch and flour from cheackpea (Cicer arie­ Hermansson, A. M. 1972. Functional properties of proteins for foods. Swelling. Lebensm.­ Wiss. u. Technol. 5( 1): 24. Kuntz, D. A., Nelson, A. 1 ... Steinberg, M. P.. and Wei. L. S. 1970. Control of chalkmess in soymilk. J. Food Sci. 43: 1279. Pilooof. A. M. R., Bartholomai. G. B. and Chirife. J. 1982. Kinetics of nitrogen solubility loss in heated flour and protein isolates Rdston. M. L. and Jennrich, 1­ 1978. Dud. a derivative free algo­ from bean, Phaseolus vulgaris. J. Food Sci. 47( 1): 4. Romo. C. R. 1980. The extraction characterization together with rithm for nonlinear least squares. Technometrics 20( 1). nutritional and technological properties of protein contained in chilean bean and rapeseed meal. Thesis. National CoUepc ol, Torgarsen, H. and Toledo, R. T. 1977. Physical propenies Technology. X'eybridge. preparations related to their functional characteristics g' "4\ : nuted meat systems. J. Food Sei. 42( 6): 1615. cpcc :f Urbanski. G. E.. Wei. L. S'. Nelson. A'I.. and Steinberg. M p .­ Flow characteristics of soybean constituents contro& ed'b, '% Ms received 3/ 14/ 84; reevked 7/ 21/ 84; accepted 9/ 24/ 84. of total to imbibed water. J. Food Sei. 48: 691. %.& a* assistance, and Dra. 0. Kith i s heartily thanked for her & The authors ais0 acknowledge Millipore Co. for their est in this work and for valuatile comments. I i I . l$ V* Richard R. Nelson and Terry E. Acree Respectively Graduate Research Assistant and Associate Professor of Biochemistry, Department of FoodScience, New York State Agricultural Experiment Station, Cornell University, Geneva, New York 14456. The authors gratefully acknowledge the gift of Concord pigment from G. Hrazdina, assistancein the sensory analysisfrom R. M. Butts and 1. D. Tyler, andstatisticalas­ sistance from J. Barnard. This manuscript approved by the Director of the New York State Agricultural Experi­ Presented at the Annual Meeting of the American Society of Enologists, June 23, Received June 23,1977. Accepted for publication January 17,1978. ment Station for publication as Journal Paper No. 3123. 1977, Coronado, California. 2 ? ABSTRACT I Concord grapes were harvested from the vine­ trifluoroethane). Compounds in the solvent extract vards of the New York State Agricultural Experi­ mere separated by gas chromatography and their f kent .Station, Geneva, during the 19'76 vintage. odors evaluated using a sniffing device attached I \vines \vere prepared by three techniques commonly to the gas chromatographic effluent port. Nineteen .­ for producing Concordmines of various styles. compounds were identified by combined gas chroma­ ­­.. A ,vhite \vine was prepared from 12" Brix fruit that tographyjmass ­ spectrometry. The­ wines showed pressed immediately after crushing, a red wine vastly different varietal characters that cannot be , '.. as prepared from 16" Brix fruit that was crushed explained by variation in methyl anthranilate con­ fermented on the skins, and another red wine , centration alone. Sensory analyses were conducted was prepared from 16" Brix fruit processed by in order to examine the correlation of odor intensity ' thelmal vinification. All musts were ameliorated in with methyl anthranilate concentration and total to produce finished wines containing 12:; volatile concentration. This report. demonstrates that v ,' ~ ethanol. The flavor components of each wine the volatile composition of Concord wine differs sig­ . r \\­ ere extracted with Freon 113 (1,1,2­ trichloro­ 1,2,2­ nificantly with maturity and processing technique. t i REVIEW OF LITERATURE pounds have been identified by Holley et al. (6), Literature is extensive on the flavor composition Stevens e t a]. (18) Neudoerffer et a]. (lo), and. \ of \f­ ine and other a] coho] icbeverages. The corn­ Stern et d. (16). Particular attention has been given pounds identified have been thoroughly reviewed bs­ to the role of methyl anthranilate in the varietal i. Kahn (7) and by Webb and Muller (19). There has Chal. aCter of native h e r i c a n Varieties in work b; v l been little investigation, however, into the effects of Scott (131, Sale and U'ilson (12), Fufeki (41, . ' the \volatile composition of table wines. Shaulis and This report examines the volatile composition of ; Robinson ( 14) noted the importance of seasonal Concord wine by instrumental and sensory means as by fruit maturity and by enological tech­ ­ ' ' season, maturity, and fermentation technique on l% xIman (3), and Nelson et a]. (9). t 'hariation on methyl anthranilate concentration in affected ,' Concord and Fredonia grapes. Stevens et al. (17) nique­ '. compared volatiles isolated. from Grenache juice and ' 1 , from Grenache Rose wine. Hardy (5 ) examined MATERIALS AND METHODS :'flavor development in Muscat of Alexandria grapes . Wine preparation: The experimental wines were ' ,,, during ripening, and Stern et al. (15) followed cow­ . prepared from 40­ kg lots of Concord grapes har­ k$? sitional changes of Zinfandel \Tine during aging. vested during the 19T6 \­ intage. The fruit was har­ \A,.; The volatile composition ofConcord juice has vested by hand, separated from the steqs and leaves 1 studied by several workers. A total of 85 com­ in a modified Healdsburg stemmel­ (S ), :and crushed 83 .' .. .. . . Am. J. Enol. Vitic., VoL 23, No. 2,1978 .. '! I ­ ~ ~ ~­~­­~ ". ~ "" b ~u I Y L V ~~U WINE COMPOSITiON : 4 in a fluted roller­ type crusher. Sulfur dioxide was added as potassium metabisulfite to a level of 100 ppm. All musts were ameliorated with sucrose to 21" Brix and then fermented with a Montrachet 522 ... dry­ yeast inoculum. Enologicai variables were as follows: a) A white wine was prepared from Con­ cord grapes harvested at 11.9" Brix. Immediately Lw, ' after crushing, the juice was expressed with a hy­ draulic rack and cloth press. The must was settled for 12 hours, and the clear portion was then racked into glass fermentors and inoculated. b) A red wine was prepared by fermenting crushed 16" Brix Con­ cord grapes in contact with the skin for five days. The skins were then removed, ameliorant was added, and the fermentation was completed in glass fer­ mentors. c) The third sample was prepared by bringing crushed 16" Brix grapes to 60° C for 15 minutes in a steam kettle. The juice was then drawn off and settled for 12 hours, and the clear portion was racked into glass fermentors, ameliorated, and inoculated. \ Sofventextraction: The volatile components .of the ,finished wines were isolated by solvent extrac­ tion with Freon 113 (1,1,2­ trichloro­ 1,2,2­ trifluoro­ ethane). Equal parts (3000 ml) wine and solvent were stirred for 30 minutes, and the solvent layer was removed, dried over anhydrous .MgSO,, and finally concentrated 12,000­ fold in a rotary evapo­ rator at 20° C. instrumentalanalysis: Organoleptic analysis of the GC effluent was done on a Packard 800 gas 1::; chromatograph with a 4­ m x 2­ mm glass column 2 packed with 10% SP­ 1000 on. Chromosorb W. The c, sensory character as each compound emerged was as­ sessed .with a sniffing device attached to the effluent port of the GC (1). Volatile components were identi­ fied with a Varian 1400 gas chromatograph equipped with a similar column and interfaced to a Bendix 12 time­ of­ flight mass spectrometer. The eompo­ nents were quantified with a Hewlett­ Packard 5830 A gas chromatograph with a 4­ m x 2­ mm stainless: steel column and ­the same packing material. The internal standard was dodecanol. . . Sensory analysis: Sensory analyses were made by the seven­ member wine­ variety­ eyaluation taste panel of the New York State Agricultural Experi­ ment Station. Two questions were asked: 1) are there detectable differences between samples ; and 2) what is the magnitude of any differences? Com­ pletely randomized triangle tests were used for the first analysis, and scoring on an unstructured scale was used for the second. Several other samples were included for reference : White Riesling, Delaware, Catawba, and. ,two synthetic samples prepared by adding the 19 compounds identified by GC/ MS in amounts found in the thermally vinified sample to a solution of 12% v/ v ethanol and 0.75oJo w/ w ,._". tartaric acid in distilled water. Methyl anthranilate i was omitted from one of the synthetic samples. To (\< exclude bias due to color differences, pigment iso­ . .I iated from Concord grape juice was added to an samples until the color matched the thermally pipi. f ied sample. RESULTS AND DISCUSSION Fig. 1 shows typical chromatograms of the &re, Concord extracts. A total of 64 compounds were de. tected in the cold pressed white wine (coded Cpw), 64 compounds in the red wine fermented on the skins 21 Fig. 1. Chromatograms of 12,000­ fold essenceextracted from cold­ pressed white, fermented­ on­ skins red, and thermally vinified red Concord wine. L y , Am. J. Enol. Vitic., Voi. 29, No. 2, '1978 ., .. .~ , ".. Table 1. Volatile composition ofConcord wine. R " i Cornpound Cold­ Fermented Thermally Retention pressed on skins vinified time (W ) (w l l ) (W l ) (mid " trt;, 4 acetate a Is.? butyl acetate f: hyf butyrate 1 tsjamyl acetate . b~ amyt alcohol Ethyl hexanoate i Hexyl acetate Ethyl lactate ' i : .:`: '::?. Hexanot .. Diethylsuccinate Phenethyl acetate [ Hexanoic acid '. Phenethyl alcohol ' Octanoic acid 250 29 140 1400 61 00 730 ndb 280 20 370 50 1 20 1800 9000 41 0 36 340 140 5 49 1300 470 460 120 280 340 130 ' 96 1900 1200 5200 4300 6300 2400 51 0 200 170 6200 8900 630 57 230 170 41 1100 640 240 860 1600 71 00 5600 4.3 7.4 8.0 10.9 13.8 14.7 16.0 18.4 18.6 19.7 21.8 28.7 29.8 34.6 34.8 37.6 43.1 ­ Methyl anthranilate 660 380 560 553 ­ Decanoic acid 2200 640 2300 57.7 *Concentration of compounds calculated ona single­ strength wine basis as determined with dodecanol used as the internal ? standard. * nd = not detected. Table 2. Classification of .volatile components of Concord wine. .. .. ,­ i Processing techniques Class CPW OSR TVR 7.8 Acids 10.4 4.2 ' 9.5 Alcohols 11.3 13.5 ?.. : . .. 16.2 .. . Esters 3.9 2.2 3.6 &:. d Total essence 27.4 22.3 37.1 i Acetates 1.8 (ppml 2.4 i .' . CpW, `cold­ pressed white; OSR, on­ the­ skinsred; N R , ther­ mally vinified red. .. ., .. Am. 3. Enol. Vitic., CONCORD WINE COMPOSlTlON­ 85 triangle tests. The results are given in Table 3. Six ' of the seven panelists could successfully distinguish CPW from OSR, all seven panelists could distinguish OSR from TVR, and five panelists could distin­ guish CPW from TVR. The respective results are significant at p = 0.01, p = 0.001, and p = 0.05 (2). The intensity of typical "American" or "la­ brusca" character was investigated by scoring on an unstructured scale (Fig. 2) from 0, no detectable "labrusca" character, to 20, extremely intense "la­ brusca" character. The compiled data were evalu­ ated by a two­ way analysis of variance followed by Duncan's multiple­ range test. The results are shown in Table 4. It is apparent that the white wine made from low Brix grapes is significantly lower in "la­ brusca" character than the other Concord samples. Although it is not surprising that the Catawba wine was scored relatively high in "labrusca" char­ acter, it is interesting that the methyl anthranilate concentration of that sample was less than 0.1 ppm. It can also be seen that the synthetic wines were poor imitations of "1abrusca"­ flavored wines, re­ gardless of the presence or absence of methyl anthranilate.. Statistically, the CPW wine has no more "labrusca". character than the Delaware or the White Riesling wines. That appears to confirm the thought that the compounds responsible for Concord varietal character are formed during the latter stages of maturation. Although Robinson and Shaulis (11) showed that to be true for methyl anthranilate formation, this work indicates that it is not responsible for varietal character. Although both red wines have distinctive. `` la­ brusca" character, they are quite different from each other. The compounds responsible for the difference have not yet been positively identified. It seems, however, that the extremely high level of acetates in the thermally vinified wine, particularly isobutyl, isoamxl, and phenethyl, may play a role. Table 5 lists the acetates detected and the relative amounts found in the two red Concord wines. Each com­ pound has a strong fruity or spicy aroma that could contribute to the character of the thermally vinified wine. Table 3. Varietal character: difference test. (Randomizedtriangletests) Comparison % correctresponse Level of significance CPWa vs. OSRb 86 .01 CPW vs. TVRc 71 .05 OSR vs. TVR loo . .001 a Cold pressed white wine. Red wine fermented in contact with skins. e Thermally vinified red wine. I Vol. 29, No. 2,1978 .. ~~ ~~ .. .. .. 86­ CONCORDWINECOMPOSITION ­ Table 4. Analysis of variance and Duncan's multiple­ range test. Sample Treatment Mean Concord Therm. vinif. 14.43 Concord Ferm. on skins 12.36 Catawba Cold press 11.36 Concord Cold press 7.07 Delaware Cold press 6.21 Riesling Cold press 5.64 Synthetic No met. anth. 5.07 Synthetic With met. anth. 1.93 ­____ Error df = 42, Error ms = 30.1477, F = 4.2000, LSD = 6.0397. In conclusion, the thermally vinified wine had a higher odor intensity than the other wines. It also had a higher level of total extractable volatiles. Even so, the white wine was significantly lower in odor intensity yet had a higher level of extractable volatiles than the wine fermented on the skins. The lower level of total volatiles in the sample fermented on the skins did not appear to affect odor intensity significantly. Thermal vinification, through the production of high levels of acetates or other compounds, yields a wine with maximunl intensity of Concord aroma. It can be concluded, however, that the Concord varietal character is composed of ­one 01­ more trace compo­ nents that have yet to be identified and that these compounds are formed during the latter stages of maturation. . The nineteen compounds identified, including methyl anthranilate, constituted over 90% of the total extractable essence. These compounds certainly contribute to the "\* inous" character of Concord wine but make little 01­ no contribution to Concord varietal character. Identification of the compounds responsible for the varietal character in Concord and other wine varieties will rest yith the identifica­ tion of trace components present in pg/ 1 quantities. ODOR EVALUATION OF ''AMERICAN CHARACTER Taster Date Directions ­ Examine the odor of each wipe: Rate the intensity of typical "American" character according to your own defini­ tion and experience by placing a vertical line at the appropriate position on the scale provided.. Sample "American" Low High 71 23 " 44 60 Fig. 2. Unstructured scaleused in scoring intensity of "labrusca" odor in experimental wines. Responses were con­ verted for statistical analysis using a20­ pt grid. 1 1 Table 5. Relative acetate concentration in red Concord wine. CompoundFerrn. on skins Therm. vinification X in,­; ~ Ethyl acetate ­"­. 38 Isobutyl acetate 50 200 300 Isoamyl acetate 1 E? 6200 244 Hexyl acetate 36 57 96 58 Phenethyl acetate 860 796 " 370 510 \ LITERATURE CITED 1. Acree, T. E., R. M. Butts, R. R. Nelson, and C. y. L ~~, ,Sniffer to determine the odor of gas chromatographic efil,,. ents. Anal. Chem. 48: 12,1821 (1976). 2. Amerine, M. A., and E. B. Roessler. Wines: Their SensorV Evaluation. W. H. Freeman and Co., San Francisco. Appendix D, p. 181 (1976). 3. Friedman, t. E. Concord grape quality. N. Y. S. Nortic. sot. Proc. 121: 132­ 6 (1976). 4. Futeki, T. Methyl anthranilate and total volatile estero content of grape cultivars grown in Ontario. hpubl. Paper presented at the, Annual. Meeting of the American Society of Enologists, EasternSection, Erie, Pennsytvania, August, 1976. 5. Hardy, P. J. Changes in volatiles of Muscat grapes dur­ ing ripening. Phytochemistry 9: 709­ 75 (1970). 6. Holley, R. W., B. Stoyla, and A. D. Holley. The identifica. tion of some volatile constituents of Concord grape juice. Food Res. 20: 326­ 30 (1955). 7. Kahn, J. H. Compounds identified in whiskey, wine, and . beer: a tabuiation. J. Assoc. Off. Anal. Chem. 52: 1766­ 78( 1969). 8. Moyer, J­ C. An experimental grape stemmer. Farm Res. 23: 1,15 (1957). 9. Nelson, R. R., T. E. Acree, C. Y. Lee, and R. M. Butts., Methyl anthranilate as an aroma constituent of American wine. J. Food Sci. 42: 57­ 9 (1977). IO. Neudoerifer, T. S., S. Sandler, E. Zubeckis, and M. D. Smith. Detection of an undesirable anomaly in Concord grape i by gaschromatography. J. Agric. FoodChem, 13( 6): 584­ 8 (1965). 11. Robinson, W. B., and N. J. Shaulis. Ripening studies of grapes grown in 1948 for juice manufacture. Fruit Prod. J. Am. . Food Manuf. 29: 2.36­ 7,54,62 (1949). 12. Sale, J. W., and J. 8. Wilson. Distribution of volatile flavor in grapes and grapejuices. J. Agric. Res. 33: 307­ 10 13. Scott, R. D. Methyl anthranilate in grape beverages and flavors. Ind. Eng. Chem. 15: 732­ 3 (1923). 14. Shaulis, N. J., and W. B. Robinson. The effect of season, i pruning severity, and trellising on some chemical character­ ­: istics of ConcordandFredonia grape juice. Proc. Am. Hortic. . 15. Stern, 0. J., G. Guadagni, and K. L. Stevens. Agingof wine: changes in Zinfandel volatiles. Am. J. Enol. Vitic. 26: 16. Stern, 0. J., A. Lee, W. H. McFadden, and K. L. Stevens. Volatiles from grapes: identification of volatiles from Concord essence. J. Agric. Food Chem. 15: llOO­ 3 (1967). 17. Stevens, K. L., R. A. Flath, L. Alson, and D. J. Stern. Volatiles from grapes: comparison of Grenache juice and Grenache Rosewine. J. Agric. Food Chem. 17: 1102­ 6( 1969). 18. Stevens, K. L. A. Lee, W. H. McFadden, and R. Teranishi. Volatiles .from grapes: some volatiles from Concord essence. J Food Sei. 30: 1106­ 7 (1965). 19. Webb, A D., and C. J. Muller. Volatile aromacompo­ nents of wines and' other fermented beverages. Adv. &PI. Microbiol. 15: 75­ 146,( 1972). (1926): SOC. 62: 214­ 20 (1953). 208­ 13 (1975). 1 Am. J. Enol. Vitic., Vol. 29, No. 2,1978 .. .. :.. . _... ­. . .. . x .. .. . . .. . . . ­ . . ..,_ 2 The Odor Quality o f Labrusca Grapes TERRY E. ACREE New York StateAgricultural Experiment Station, Cornell University, Geneva. NY 14456 C u l t i v a r s o f t h e s p e c i e s vinifera are the most p r e v a l e n t g r a p e s p l a n t e d i n ­t h e w o r l d . O r i g i n a l l y grown i n Europe and Asia . v i n i f e r a g r a p e s . o f w h i c h ,t h e r e a r e s e v e r a l thousand named c u l t i v a r s (i ). a l s o d o m i n a t e t h e v i t i c u l t u r e of the New Vorld. In North &erica. however, two o t h e r s p e c i e s of (h b r u s u , Bailey and L p t u n d i f o u . Hicha'ux) are growo i n s i g n i f i c a n t q u a n t i t i e s (?). The s e v e r e c l i r c a t e a n d v i r u l e n t d i s e a s e i n c e n t r a l and e a s t e r n N o r t h America made early c u l t i v a t i o n o f v i n i f e r a g r a p e s l a r g e l y m s u c c e s s f u l , a t l e a s t i n t h e E n g l i s h C o l o n i e s . T h i s s t i m l a t e d t h e h y b r i d i z a t i o n and c u l t i v a t i o n o f t h e c o r e t o l e r a n t n a t i v e g r a p e s p e c i e s f o r many years. With t h e d e v e l o p e c t of n e t h o d s f o r d i s e a s e c o n t r o l acd the expansion of v i t i c c l t u r e i n t o c l i m a t e s more amenable t o .v i n i f e r a g r a p e s , t h e p e r c e n t o f n a t i v e s p e c i e s h a s d e c r e a s e d ­ t o l e s s t h a n f i v e p e r c e n t of the total Korth American .grape production (2 ). Alth6uL. h dwarfed by t h e s i z e of t h e v i n i f e r a g r a p e c r o p , i n excess of 4.000.00@ t o n s , t h e p r o d u c t i o n af labrusca grapes has increased i n the last 30 y e a r s . T h i s c o n t i n u e d d e n a c d f o r l a b r u s c a g r a p e s is due t o t h e i r s u p e r i o r q u a l i t y for the production of grape juice and j e l l y . I t is t h e u n i q u e f l a v o r o f labrusca grapes. and i n p a r t i c u l a r t h e c u l t i v a r Concord; that i s r e s p o n s i b l e f o r t h e i r s u p e r i o r i t y . I n f a c t . t h e . f l a v o r o f labrusca grapes has . become t h e s t a n d a r d of i d e n t i t y €o r g r a p e juice and j e l l y i n n o r t h America. TtiE m O R OF LaBBllscBsBhEEs The major flavor differences among grape prcducts nade with d i f f e r e n t s p e c i e s o f g r a p e s a r e f o u n d i n t h e o l o r . It is e a s y t o d i s t i n g u i s h t h e o d o r s of g r a p e j u i c e s made from vinifera. l a b r u s c a . a n $ m u s c a d i n e s p e c i e s . I n c o n t r a s t , t h e t a s t e of g r a p e s , t h a t is t h e i r s w e e t n e s s . . sourness, and b i t t e r n e s s . is frequently manipulated by p r o c e s s o r s t o t h e e x t e n t t h a t a:; y t z s t e difference among grapes of l i f f e r e n t s p e c i e s a r e o b l i t e r a t e d . The one word which has been used €o r c e n t u r i e s t o ' d e s c r i b e t h e o d o r c h a r a c t e r o f n a t i v e g r a p e s is foxy". In f a c t e a r l y .. 009~­ 6~ 5~/~ 1/ 0170­~ 01 lSOS. OO/ O 0 1981 American Chemical Society 12 QUALITY OF SELECTED FRUITS AND VEGETABLES 2. ACREt European v i s i t o r s t o t h e New World named t h e n a t i v e l a b r u s c a g r a p e s g r o w i n g i n New England the Northern Fox G r a p e , a n d t h e grapes growing i n t h e S o u t h t h e S o u t h e r n Fox Grape. The o r i g i n a l meaning of t h e word "foxy" was e x p l i c i t l y s t a t e d i n 1722 by Robert Beverly when h e d e s c r i b e d the smell o f .t h e s e g r a p e s a s resembling t h a t o f a fox(&). This musky a n i m a l ­l i k e a r o n a is s t i l l c o n s i d e r e d a n u n d e s i r a b l e a t t r i b u t e i n &r a p e s . b u t "f o x y " m u s t not b e c o n f u s e d w i t h t h e p o w e r f u l f r u i t y I f l o r a l , o r candy o d o r s e s s e n t i a l t o t h e q u a l i t y o f g r a p e j u i c e a n d j e l l y . Even t h o u g h t h e s e o d o r s may n o t b e a p p r e c i a t e d i n most wine types, they are n o t t h e same as f o x i n e s s . T h e c u l t i v a r s of w r u s c m (Concord, Catawba. Delaware, etc.) were appreciated by e a r l y A m e r i c a n g r a p e b r e e d e r s b e c a u s e o f t h e i r g e n e r a l l a c k of foxiness. However, Niagara i s t h e o n e r e m a i n i n g . counercial c u l t i v a r w h i c h h a s a l v a y s b e e n c o n s i d e r e d f o x y . T h e r e f o r e , f o x i n e s s s h o u l d n o t b e c o n s i d e r e d t h e d o m i n a n t o d o r q u a l i t y o f L n b r u s c a g r a p e s . I n t h i s p a p e r , t h a t o d o r q u e l i t y c o m o n t o 611 f a b r u s c a g r a p e s will be r e f e r r e d t o a s "l a b r u s c a c h a r a c t e r . D u r i n g t h e s e n s o r y s t u d i e s o f h u n d r e d s of d i f f e r e n t g r a p e c u l t i v a r s c o n d u c t e d a t t h e E x p e r i m e n t S t a t i o n i n Geneva, New `iurk. p a n e l i s t s h a v e , w i t h g r e a t r e g u l a r i t y , i d e n t i f i e d t h e presence of l a b r u s c a c h a r a c t e r i n t h e o d o r of l a b r u s c a g r a p e s and e [ t e n d o t h e s a n e w i t h h y b r i d c r o s s e s b e t w e e c y. b b r u s u and cther g r a p e s p e c i e s . F u r t h e m o r e , t h e y c a n d e t e c t t h e p r e s e c c e o f s p e c i f i c o d o r ­ c o n p o n e n t s , w h i c h i n v a r y i n g d e g r e e s , seem t o make L I ~ ' t h e t o t a l s e n s o r y e f f e c t . F o u r d e s c r i p t o r s w h i c h are irequently used by t h e s e p a p e l i s t s a r e f o x y ­,"f l o r a l ". n e t h y l ~n t h r a n i l a t e ­l i k e ' *, and "cotton candy". It is c e r t a i n l y u n w i s e cia a s s u m e t h a t t h e s e o d o r c o m p o n e n t s a r e . i n every c a s e . r e l a t e d t o s i n g l e c h e m i c a l s p e c i e s . b u t t h e y a r e p r o b a b l y less c o m p l i c a t e d i n t h e i r c t m i s t r y t h a n t h e conpound mix t h a t p r o d u c e s t h e t o t a l p e r c e p t i o n o f l a b r u s c a c h a r a c t e r . Such d e s c r i p t o r s are u s e f u l i n o u r a t t e m p t s t o s o r t o u t t h e s,, alI number of odor­ active compounds present i n n a t u r o l products. However, they have l i t t l e m e a n i n g f r o n o n e l a b o r a t o r y t o t h e n e x t . F o r e x a m p l e . t h e a r o m a d e s c r i b e d i n o u r v o r k as cotton candy" appears, for r e a s o n s w h i c h w i l l b e e x p l a i n e d l a t e r , t o b e d u e t o t h e same compoufid responsible f o r t h e s t r a w b e r r y o d o r d e t e c t e d i n t h e l a b o r a t o r y of Rapp( j) in Gemany. Tne c o n f u s i o n t h e s e n o n ­c h e m i c a l d e s c r i p t o r s c r e a t e , w i l l be ninimized once WE know t h e c a u s a t i v e a g e n t s for o d o r p e r c e p t i o n . Then we can use a chemical name t o d e s c r i b e t h a t p e r c e p t i o n . In t i t & meantime, we must t o l e r a t e t o some e x t e n t t h e u s e o f t h e s e v o r d s i n o u r d a y ­t o ­d a y r e s e a r c h . ,IETHYL AHTHRAFI~ Studies Gf t h e v o l a t i l e c o m p o s i t i o n of grapes have, through the y e a r s , r e v e a l e d t h e p r e s e c c e of so many odor­ active coapocnds t h a t i t is v e r y u n l i k e l y t h a t a s i n g l e compound i s responsible for more than a f e w p e r c e n t o f t h e t o t a l o d o r c h a r a c t e r o f g r a p e s ,* f any kind( h). Furthermore, among t h e h u n d r e d s of v o l a t i l e s .. .. .. .. present o d o r a c t present together c u l t i v a r a specif One e v e r a s s ) (1). h i produce i n g r a p e anthrani 3 abrus ca i n o n l y nethyl a t h i s co t h e l a b r labrusca Ha n t o have o d o r t b r to v i n i labrusca There a propyl, i n l a b r u contribu placed For exarn i n d i c a t e t h e q u a l t h e p e r t h e anou e s t e r c breeders odor cha One preseccc products f l a v o r s of flavc unintent FOXIKES$ f r o n 1 2 been ur "2 ­ has an grapes. I n so abrusca s n d t h e e. The in 1722 ipeS a s ma i s candy . Even types . ruscana e a r l y ack of ­r e r c i a l r e f ore, i t y o f , t o a l l grape Jar New zd t h e pes and and x c e o f 3 make c11 are .. foxy­ 0. t h a t u t . t h e :la t urz 1 s r a t o r y .roGk as plained i o r t h e .en;; any. . i. 11 be epdion. n. ' I n f t h e s e 2. ACREE Odor Quality of Lahrrtsca Grapes 13 p r e s e n t i n g r a p e s (F i g u r e I.)* only a very feK probably have any o d o r a c t i v i t y . T h e r e m u s t e x i s t a number of c h m i c a l compounds p r e s e n t i n g r a p e s a t p a r t i c u l a r c o n c e n t r a t i o n s t h a t when taken together produce t h e c h a r a c t e r i s t i c o d o r q c a l i t y o f a p a r t i c u l a r c u l t i v a r . A s s o c i a t e d w i t h e a c h of t h e s e o d o r ­a c t i v e c h e m i c a l s is a s p e c i f i c . though n o t n e c e s s a r i l y u n i q u e , o& or q u a l i t y . One such compound i s m e t h y l a n t h r a n i l a t e , t h e f i r s t conpound ever associated w i t h o d o r c h a r a c t e r of a p a r t i c c l a r g r a p e s p e c i e s (2 ). O r i g i n a l l y i d e n t i f i e d i n n e r o l i o i l (8) it vss u s e d t o produce synthetic grape­ flavored products before i t vas observed i n g r a p e s . In 1923 S a l e a n d W i l s o n (2 ) a n a l y z e d t h e m e t h y l a n t h r a n i l a t e c o n t e n t i n 55 c u l t i v a r s of g r a p e s . i n c l u d i n g b o t h labrusca and v i n i f e r a c u l t i v a r s . They f o u n d m e t h y l a n t h r a n i l a t e i n , o n l y 14 of t h e s e . I n 1976 using gas chromatography. we found m e t h y l a n t h r a n i l a t e i n only 8 of 4 5 c u l t i v a r s (m). Certainly t h i s compound p l a y s a n i m p o r t a n t r o l e i n t h e f l a v o r of sone of t h e l a b r u s c a g r a p e s b u t i t i s n o t ­ s o l e l y r e s p o n s i b l e f o r t h .e l a b r u s c a c h a r a c t e r . Nany v i n e s w i t h a s t r o n g l a b r u s c a c h a r a c t e r h a v e b e e n f o u n d t o have a methyl a n t h r a n i l a t e c o n t e n t vel1 below t h e a p p a r e n t odor threshold (m). F u r t h e r n o r e , t h e a d d i t i o n o f t h i s compound t o v i n i f e r a v i n e s a t v e r y h i g h c o n c e n t r a t i o n s d o e s n o t p r o d u c e a labrusca aroma n o r d o e s i t produce a v i n e w i t h any foxiness. There are small amounts of o t h e r a n t h r a n i l a t e e s t e r s . e t h y l . propyl, =.­ butyl and the analogous compound p­ aminoacetophenone i n l a b r u s c a g r a p e s b u t t h e r e are n o d a t a e x p l a i n i n g t h e i r precise contribution, i f any, t o t h e =e t h y l a n t h r a n i l a t e ­l i k e aroma. I n t h e l a s t 60 y e a r s , p e r h a p s t o o much e q h a s i s has beer. placed on t h e m e t h y l a n t h r a n i l a t e c o n t e n t of l a b r u s c a g r a p e s . For example. ueasurements of t h i s cornpour. 6 heve beer. used t o i n d i c a t e g r a p e n a t u r i t y (u ); it has been used as a n i n d i c z t o r of t h e q u a l i t y o f g r a p e p r o d u c t s (u ), and as z means of nonitorinL t h e p e r f o r m a n c e o f e s s e n c e r e c o v e r y e q u i p z e n t (u ). F u r t h e r m o r e , t h e amount of methyl . a n t h r a n i l a t e c o m b i n e d . w i t h t h e v o l a t i l e e s t e r c o n t e c t of grapes is p r e s e n t l y b e i n g used t o a i d t h e g r a p e b r e e d e r s i n t h e i r a t t e m p t t o p r o d u c e new c u l t i v a r s w i t h c e r t a i n o d o r c h a r a c t e r i s t i c s (&). One of t h e d a n g e r s o f p l a c i n g t o o much inportance on the p r e s e n c e o f m e t h y l a n t h r a n i l a t e i n g r a p e p r o t u c t s i s t h a t s u c h products may tend t o snell more l i k e t h e s i m p l e i m i t z t i o n g r a p e f l a v o r s r a t h e r t h a n t h e n a t u r a l p r o d u c t . I t i s one of t h e g o a l s of f l a v o r r e s e a r c h t o p r e v e n t s u c h i r o n i e s f r o e o c c b r r i n g unintentionally. FOXINESS So f a r o u r a t t e m p t s to i s o l a t e L? pure chemical component f r o m l a b r u s c a o r a u s c a d i n e g r a p e s . w i t h a c l e a r f o x y odor have b e e n u n s u c e s s f u l . T h e r e is, h o w e v e r r o n e c c n p o n e n t , grans­ 2­ texen­ 1­ 01. apparently present in a l l g r a p e s p e c i e s . t h a t h a s a n o d o r . v e r y siniilar t o t h e f o x y oZor cooponect of Kiagara g r a p e s . P o s s i b l y . t h i s c o m p o u n d . i s p r e s e n t i n f o x y ­s n e l l i n g 14 < .. " ." 7 I 31VLllN33NO3 A 000'tl NO113VUJ *% E 2. ACRE1 grapes B t h e i r odo concentra 10 times breeders commercia grapes t c o m e r c i a foxy f l a v x€ uLu& w I n a present d e a c t i v a t p o l a r i t y and 100% p o l a r i t y e x t r a c t s was t h e c h a r a c t e r presence reported n a t u r e 1 p The labrusca anouhts o v i n i f e r a products Concord t h a t foun chardonna Bece products t h e o d o r c o n t r i b u t s u b s t a n t i threshold t h e n e t h grapes is Besi o t h e r goo such con r e n i n i s c c COTTOA Q! Experimer q u a l i t y c f o r t h e has been p o l l u t i o r t h e o d o r 1.3­ cycl0 For 16 QUALITY 01; SELECTED FRUITS AND VEGETABLES 2: ACRI 1: 40 20 100% 40 20 100% 80 60 40 20 100% 80 60 40 20 20 40 60 80 100 120 140 M /e i I 20 40 80 100 120 140 M /e QUALITY OF SELECTED FRUITS AND VEGETABLES COMPOUND ODOR QUALITY 0 DAMASCENONC FOXY ANIMAL . FlORAl FRUITY COTTON CANDY STRAWBERRY BURNT SUGAR ". " 2. 90 _­ Anhvestigation of the Volatile Flavor Composition of V'tus Labrusca Grape Musts and Wines. 1. Methyl Anthranilate ­ Its Role in the Total Aroma Picture of Labrusca Varieties.* Richard H. Tomlinson and Joe boison* I' Contribution from Ckemistq Dqartment, McNaster LTniversitzj,. Canada U S &Ill and the Chemistry Department, University of Saskatchewan; Saskatoon, Canada S7N OW0 . L'anthranilate de mifhyle u 4tZ considhi comme 6tant le. compos4 volatile le pfas &terminant dans l'ar6me des vins et des moicts de misinq uConcozrl" et f u t longtemps considirC conrme Ctant l'agent r& Cla­ tmr du go5t dissimzd& associ4 ti l'ardmedes uins 'Concord" et des autres variltts Vitis labrusca. Des risultats exphimentaux notweaux uiennent demon­ trerqzte des compos& colatiles aromatiques azttres qtre l'anthmnilate de d t h y l e peurent dtre des agents ri­ vdlateurs del'ar6me camcteristique de ces variit4s nard­ amh'caines. Abstract Methyi anthranilate has been proposed as the single most important volatileflavor component in Concord grape musts and wines and has long been held respon­ sible for imparting the typical "ffoxiness" associated with the flavor of Concord and other Vitis labrusca Varieties. New experimental evidence is presented to demonstrate that volatileflavor compounds other than methyl anthranilate m y be respomible for imparting the typical flavor associated with these native North American varieties. $ Presented as part of a session on uAnalysis of Trace Components in Alcoholic Beverages", Cas& 86 Xeeting, Toronto, Ontario, Canada, October 64,1986. * Author to whom correspondence m y be directed. e n t address: Agricuiture Canada. Food ProductionandInspectionBranch, Animal Pathology Laboratory, 116 Veterinary Road, University of Saskatchewan Campus, Saskatoon, Saskatchewan, ­ Canada C717 9Dr) Methyl anthranilate has been considered the single, ­ "­ .most important volatile flavor component in Concord grape ­musts and wines since its presence was fwt detected in Concord grapes by Power and Chestnut in 1921 (1). Subsequently, its presence in several Vitis . labmica varieties has been confirmed by Scott (21, Sale and Wson (31, Robinson et al. '( 4­ 7), and by. HoIIey' et d. (8). This compound has been held responsible for imparting the "foxiness" associated with the flavor of the native North American varieties Witis Zabntsca) and their hybrids. This viewpoint has been so preva­ lent in the minds of vintners and viticulturalists in the eastern United States and Canada, where the grapes of the pative vines form the backbone of the wine industry, that viticultural and vinification practices in this region have hitherto been Focussed on the reduc­ tion or total removal of this compound from the prod­ ucts they make for consumers. These practices have unfortunately not yielded the anticipated superior ­wines. Could it be that vintners and viticulturalists in the eastern, United States and Canada have geared their efforts to the removal of a cornpound which is not sole13 responsible for imparting the "distasteful" characteristics associated with these varieties? More recent investigations into the volatiie aroma composition of the native North American grapes and wines have ,paid particular attention t o the role of methyl anbhfanilate in the overall aroma of these vari­ . ' ­ eties (9­ 15). iri? lile it has been established that the vola­ tile aroma eomposition of Concord depends signifi­ cantly on p e processing technique (141, it is becoming increasingly $ear that the flavor character is ti^^ of these native &iieties cannot be explained by the presence Investigation of Volatile Flmor Composition in Wines ­7 or absence of methyl anthranilate alone. Some native I. D.) glass column packed with Superpak 20 M (Anal­ . . varieties such as Baco Noir, Elvira, Delaware (161, abs, Connecticut, U. S. A.) held in a Varian 1800 Gas Aurore (16,18), and Catawba (16,17,21) show no .Chromatograph. The injection port temperature was detectable concentrations of methyl anthranilate and set at 250% and the oven temperature was programmed yet possess the distinctive Labrusca flavor. Various ­ "­. from 20­ 200° C at G" C/ min and held at the final temper­ authors have also concluded that methyl anthranilate ature for 10 min. A glass­ lined microsample splitter done cannot be the most significant odorous compo­ fitted at the end of the colUmn provided an approxi­ nent in Vitk labrusca varieties (12,14,1921): Although mately 1: lO split ratio of the chromatographic effluent previous investigators have speculated that the possi­ to oneof two flame ionization detectors (FID set at ble presence of one or more compounds, other than 250° C) and an exit port. Th'e exit port effluent was methyl anthranilate, may rather be responsible for either directed to a fraction collector or a heated recep imparting the typical hbrusca flavor to these vari­ tacle (SNIFF PORT) where the nose of the experi­ eties (14), there is no evidence in the literature that menter could evaluate its significance. such compourids have been detected and identified. This paper presents new experimental evidence to clarify the role of methyl anthranilate in the total aroma picture Packed Column GClMS Analysis of the native North American varieties in a continuing research effort to identify the compound( s) that To provide qualititiie. 'identification of the compo­ . ' adequately portray the flavor characteristics of the nents separated by gas chromatography., GC'separa­ . Yitis labrusca varieties. tion was conducted on an identicalcolumnused for the packed column GC analysis held in a Varian 3700 Gas p,:? Experimental focussing, magnetic­ sector mass spedrometer (> IX70­ . ­. . ~ .. .. Chromatograph coupled to a high­ resolution, double­ Ld 70F, VG Analytical Ltd. Altrincham, England) Aiamtus and Materials . a jet separator. r . A newdesign of solvent extractor was developed for this analysis. It was used in conjunction with a new design of concentrator apparatus to successfully isolate and enrich the volatile flavor fraction from 95 mL of Cabernet Sauvignon wine using 250 mL of purified Freon­ 11 (trickdomfluoromethane) as extracting solvent (E)., Wine samples for this analysis were obtained from Chateau­ Gai Wineries, St. Catharines, Canada, An& Wineries, Canada, and the private collection of one of the authors (RHT). Isolation and Enrichment of the Volatile Flavor Extract Volatile flavor components in Pichon Lalande (Vini­ fm), Vidal (Labncscu), Concord (Lubrusca), MouIin Rouge (Labrusca), Delaware (Labrusca), Elvira (L a b c a ), and Similkameen Red (Labmsca) were . isolated and concentrated 2500­ fold, using the previ­ ously descriied method (22). The concentrated extract i "' was stored in a screw­ capped vial for further experi­ I' mentation, GC andtor GCNS analysis. GC Experimekts to Evaluate Regions of Organoleptic Significance (SNIFF PORT) Aliquots (5­ 10 pL) of the concentrated volatile flavor extract were injected into the packed column GC and a sensory description of the separated and eluting components was obtained (Figure 1). Experiments to Evaluate the Amma Contribution of the Total Extract to the Wine In order to determine if the nature of the solutions produced by mixing the flavor extract with the wine base depended on the method of mixing, a total of 20 pL of the concentrated volatile flavor extract was injected into the GC and trapped into 150 mL of cooled wine base via thelfraction collector. Samples were saved for sensory evaluation (Table I). Another 20 JLL aliquot of the same flavor extract was added diiectly to a second 150 mL portion of cooled wine base. The resulting mixtures were saved for sensofy evaluation (Table 11). ,. I ' I GC ~qeriments to Reconstitute Vitis ,. , . Gas chromatographic separation of the concentrated The .. failure of our attempts to produce homogeneous .. I ' , . PackedColumn GC Analysis Labrusca Wines . , 1,; . iz '1 1 )I ;i , .. ­ . , ,­, ­ ­ " ,,,: r ; ­ ­ 4 ­ : . ­.. c­­ ­A­ ­­ a +I... ..:" " . ­. P c c Richard H. Tomlinson & 3w Boisrm 2 .I t­ i I! .. ' P E N t I C . TIlocri=> Figure 1. Sensory description of the eluting components in the chromatographic profile of a concentrated volatile flavor extract of Concord wine on a 6 h. X 0.4­ in. O. D. (2 mm LD.) Superpak 21, Jf glass column. (Peaks represetit FID recorder responses while the descriptors represent the analyst's perception at the sniff port of the components eluting from the CC.) bases for the Labrusca varieties using the previously described isolation­ concentration procedures used successfilIy for Pichon Lalande (22) led us to conduct these procedures with a modified version of the solvent extractor and concentrator operated under carefully controlled inert­ atmospheric conditions (22). The isolated and enriched volatile flavor extracts obtained under these new operating conditions were used to repeat the previously described experiments .to eval­ uate the aroma contribution of the total extract to the wine. The results of the sensory analysis performed on the resulting homogeneous solutions are show. in Table 111. GC Experiments to Evaluate the Contribution of Sections of the Chromatographic Profile to the Wine In order to assess the aroma contribution of various fractions (especially methyl anthranilate) of the elution profile to the wine, a total of 20 pL of the concentrated volatile flavor extract obtained under the modsed conditions was injected into the column and the k c ­ tions eluting from the Superpak 20 M column were trapped jnto 150 mL of cooled \vine bases as pictorially """ ­ "_ L ­ 1 :.­ T" .. Figure 2. Partial Reconstructed Ion Chromatogram of a Standard Mixture of volatile flavor compounds depicting the experiments conducted to evaluate the flavor contribu­ tion of sections of the chromatographic profile on the wine. X. Ethyl hexanoate 2. Amyl butyrate 3. Ethyl Iactate 4. cis­ 3­ hexen­ 1st 5. .Ethyl octanoate 6. Zmethylbutyi hexanoate 7. Benzaidehyde. 8. I­ Octanol9. y­ Butyrolac­ tone 10. Ethyl benzoate 11. Ethyl decanoate 12. Diethyl succinate 13.2­ Phenethyl acetate 1.1. Hexanoic acid 15. 2­ Phenethyl alcohol 16. t­ cinnamaidehyde 17. Octanoic acid IS. Methyl anthranilate 19. Decanoic acid 20. Dh+ Llli, l­ O? 0 7%" ­­ I..­* 1 Investigation of Volalile Flavor Composition in Wina Table 1. Experiments t o Evaluate the Aroma Contribution of the Total .Extract to the Wine. 20 pL of Flavor Extract (a) 150 mL, Wme base* (b)­ Concord Xoulin Rouge Vidal Elvira Delaware S i e e n RH Pichon Lalande Observation aftera + b Concord ­ f u r f a c e Film Forme Concord Moulin Rouge Vidal Elvira Delaware Moulin Rouge .. . .. S i e e n Rei Pichon Lalande I ~ ~~ Concord Xoulin Rouge Vidal Elvim Delaware Pichon L'aIapd. Sirnilkameen Rec Von­ Homogeneous m . "med . Table 111. GC E­ xperiments to Reconstitute \'itis Labnuar Wines using the lfodiied Isolation­ Concentration Method. " Vidai Strong Burned Odor leveloped Concord Jfoufin Rouge Vidd Elvira Delaware S i e e n Red Pichon Lalande Elvira Delaware Concord Xoulin Rouge Vidal Elvira Delaware S i e e n Red Pichon Lalande Table IV. GC Experiments to Evaluate the Flavor Contribution of Sections of the Chromatographic Profile to the Wine. Concord Moulin Rouge Vi& Elvira Similkameen Red f­ Delaware Sirnilkameen Red Pichon Lalande Flavor of PI Regenerated Homogeneous Soin. Formed No Detectable hbrusca Flavor Perceived ?oncord Houlin Rouge Vidal Zlvira Pichon Lalande leiaware S i e e n Red ?ichon Lalande Wine base is the bland product ,remaining after the volatile flavor La:" L­ ­ * L 94 Richard H. Tonrlinson & Joe Boison (a) all components eluting up to and including 2­ sitions of Vitis l a h s c a varieties have been investi­ phenethyl alcohol were trapped into wine base A; gated using techniques essentially developed for Vi?& (b) all components eluting up to but excluding methyl fm varieties without any major modifications. After anthranilate were trapped into wine base B; ,the apparatus developed for this analysis was modified (c) all components eluting from 2­ phenethyl alcohol " to enable the isolation­ concentration procedures to be (inclusive) up to but excluding methyl anthranilate were trapped into wine base C; (d) all components eluting from methyl anthranilate (inclusive) and thereafter were trapped into wine base D; and (e) all components eluting except Freon solvent were trapped into wine 6ase E to serve as control. The results of the sensory evaluation of the solutions obtained in this experiment are presented in Table IV. Sensory evaluation of samples was done by a group of faculty, staff and graduate students of the Chemistry Department, 3lcMaster University, who had been trained to recognize the Labnlsca flavor. Results and Discussion The results of the GC experiments presented in Table I show that in all cases where the voIatile flavor extract was of the Labnwca origin, the introduction of the flavor extract into the wine base through the GC frac­ tion collectorproducednon­ homogeneous solutions. Note that when the volatile flavor extract was of the Vinifera origin, homogeneous solutions were obtained regardless of the origin of the wine bases. The results shown in Table I1 were obtained by introducing the flavor extracts directly into the wine bases thus elim­ inating the GC step for sample introduction used for obtaining the results presented in Table 1. Since both methods of sample introduction info the wine bases produced non­ homogeneous solutions, it was concluded that the results obtained in Tables I and I1 were not caused 'by the method of sample introduction, but may have been caused by processes occurring prior to the sample. introduction step, i. e., the isolation­ concentration procedures. Any changes caused by the isolation­ concentration procedures wouid affect either the flavor extract orr the wine base or both. In an attempt to identify the source zpd cause of the change in the Labmsca varieties, it was observed that the flavor extract of Pichon Lalange and White Riesling wines, 'both made from Vingma grapes, dissolved readily into their o m wine bases and all the' wine bases of Labmsca origin to regenerate the characteristic Cabernet Sauvignon or Riesling aroma. This obser­ vation led us to conclude that it is the flavor eitract of ,the 4bbrusca rather than the wine basg that may have 'hnilergobe change during the sample prepaiation stages. Ext, ensive review of the'liteqture dnd our own "* l" A­ l" L­ "_.. ­1 * .I L 3 ­ . .­ ­ conducted under carefully controlled inert atmospheric conditions (22), it became possible to produce homo­ geneous solutions and therefore reconstitute all the Vitis lafrrusca wines as shown in Table 111. Any further sample extraction and concentration procedures relat­ ing to the LQbncsca varieties were therefore performed under the modified operating conditions. Having developed a method that retains the original nature of the volatile flayor extract to permit the reconstitution of Lahcsea \vines, it was observed. from the results of the experiments. conducted to assess the aroma contribution of the eluting components to the wine that, besides'the control sample E, only fractions B and C trapped into the wine bases produced solutions that typsed the Lubncsca character; fraction D (methyl anthranilate) produced a solution that could hardly be described as typically Lubncsca. It is noteworthy to observe that these results and conclusions were the same for all thetabntscu varietiesinvestigated includ­ ing, E l v h andDelaware, which even showedno detectableconcentrations of methyl anthranilate. Since , fraction €3 also encompasses fraction C, which by itself imparts .the Labrusca flavor to the wine, it may be concluded that fraction C must be the most organo­ leptically significant portion of the profile of the vola­ tile flavor composition of Vitis labnlsca varieties on the Superpak 20 M column. This conclusion is rein­ forced by the results of the preliminary experiments to evaluate regions of organoleptic significance in the chromatographicprofile (Figure 1). The results in Figure 1 deiine even more precisely the region of Organoleptic interest in the chromatographic profile by confining it to the labelled section which is comprised of compounds with similar retention times to octanoic acid. Any experiments designed to detect and identify the compound( s) responsible for imparting the typical Labrusca flavor to the native North American vari­ eties should therefore be confined to the section of the chromatogram labelled 'kegion of organoleptic inter­ est" (Figure 1). Conclusions The results of these experiments confii the suspi­ cions of previous investigators that the presence or absence of methyl anthranilate alone cannot explain: the typicalflavorassociated with the native North . ' ­ L Investigation of Volatile Flavor Composition in Wines tant odorous compound in these varieties. Unlike Vitis vinifera varieties, isolation and concentration proce­ dures for the examination of the volatile flavor compo­ sition of Vitis labnrsca grape­ musts and wines must be conducted under. carefully controlled inert atmos­ pheric conditions t o prevent any possiblechemical/ structural modifications to the nature of the volatile flavor extract. The experimental evidence­ presented in this paper demonstrates that compounds other than methyl anthranilate are responsible for imparting the typical Labmca flavor. Such compound( s) are those with similar retention times to that of octanoic acid on the Superpak 20 M column. This conclusion should be of considerable significance to vinters and viticultuy­ alists in the eastern United States and Canada in help ing them to review not only their vinification and viti­ cultural practices but also their perception of the role ­ played by methyl anthranilate in the total aroma picture of the Labntsca varieties. " ... ". ­. :: ps; References L ,l I . 1. F. B. Power and V. K. Chestnut, J. h e r . Chem. Soe., L3.1741 (1921). 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. l2. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. ' ­ d \ '" . 9s R. D. Scott, Ind. Eng. Chem., IS, 732( 1923). J. W. Sale and J. B. Wilson, Agric. Res., 33, 301 (1926). W. B. Robinson and N. J. Shaulis, Proc. Amer. Hortic. Soc., 64, 214 (1953). W. 3. Robinson and N. J. Shautis, J. Amer. Food Manut, f9( 2), 36 (1949). W. B. Robinson and N. J. Shaulis, ibid., 09( 2), 54 0949). W. B. Robinson and N. J. Shaulis, ibid., 29( 2), 62 (1949). R. W. Holley, B. Stoyla and A. D. Holley, J. Food Res., PO, 326 (1953). W. J. Clore, A. M. Neubert, G. H. Carter, D. W. Ingalsbe and V. B. Dnunmond, Wash. Agric. Exp. Stat. Bull., 48 (1961. J. J. Casimir and J. C. Moyer, Proc. N. Y. WineInd. Tech. Adv. Corn, N. Y. Agric Exp. Stat.. Geneva, (1965). D. J. Stem, A. Lee, W. H. Mcfadden and K. L. Stevens, J. Agric. Food Chem., 1s. 1100 (1967). 1. E. Friedman, New York State Hortic. Soe. F'roc., 121,132 (1976). T. Fuieki, Can. J. Plant Sei., 52,863 (19n). R. R. Neison and T. E. Acree, Amer. J. Enol. Viticult,. 29( 2), 83 (1978). W. L. Stanley, J. E. Brekke, .and R. Teranishi, U. S. Patent 13113031, Dee. 3 1963 to US. Government. A. C. Rice in "Chemistry of Winemaking" Ed. A. D. Webb, Adv. in Chemistry Series #137, p. 88( 1974): A. H. Jackson, PbD. Thesis ZncliMaster University, Canada. 19i7. J. S. Caldwell. J. Agric. Res., SO. 1133( 1925). 11. A. Amerine, E. B. R w s s I e r and F. Filipello, Hilgadia, 28( 18), 500 (1959). A. D. Webb and R. ' E. Kepner, Amer. J. Enol. Vitidt,, 7, 8 (1956). R. R. Xeison. T. E. Acree and R. B­ i. Butts, J. Agric Food Chem.. 26, 1188 (1978). J. 0. Boison. Ph. D. Thesis McMister University, Canada, 1984. ­ A Cornparison of the Effect of Toxic and Non­ Toxic Metals on the Aromatic System of Salicylic Acid Wiodzimierz Lewandowski Contribution from Department of Physico­ Chemical Analyses, Agricultuml University .of Warsaw, 03­ 528 Warsaw, Rakoutiecka 26/ 30? Poland Received: November 10, 1986 Accepted (inrevised form): May 29, 1987 R6sumC Les spectres d'abso? ption IR et Raman des salicy­ lates de mercure( II), cadmium et aluminium ont dtd 6tudi6s et interpritks. On acompark l%= fluence de mereure( 1) et "( II), pLomb( II), cadmium, mgne­ sium, zinc, aluminium, fer( III), lanthane( II0, neodyme( III), disprosium( III), ytterbiumllll), .sodium et potassium sur le noyau aromatiQue de l'aeide salicilique. Pour les investigations on a applipud de la spectroscopie d'absorption Llectronique (UV, VIS) et la spectroscopie d'oscillation (celle $absorption a l'infrarouge et celle de Raman). On a constat6 que tes , .­ . .. . . ­ ,­ ;. . ­ . . . . ­ contraire de aluminium, lunthadIII), n& iynte( III), disprosium( III), ytterbium( III), fer( III), zinc et magwsiz~ ml perturbent le systi? meammatique de l'acide salicilique. Abstract ' Assignments areproposed for the IR absorptionand ' Raman spectra of mercury( II), cadmium and aluminium salicylates. Th effect of mercury( I) and 4 1 1 , l e d l l ), cadmiuwi as weld as of magnesium, zinc. aluminium, iron( III), lanthanum( III), ., f . .. .. &. r 1188 J. A&. Food Chem., Vd. 26, No. 5,. 1978 Jeon, I. J., Reineccius, G. A, Thomas, E L., J . Agric. Food Chem, 24.433 (1976). Kinsella, J. E., Chem. fnd., 36 (1969). . Kirk, J. R., Hedrick, T. I., She, C. M., J. Dairy Sci. 51,492 (1968); Langler, J. E., Day, E. A., J. Dairy Sci. 47,1291 (1964). ; Ldlard, D. A., Day, E. A., J. Dairy Sci. 44, 623 (1961). Muck, G. A,, Tobias, J., U'hitney, R. M., J. Dairy Sci. 46, 774: (1963). Whitney, R. M. J . Dairy Sci. 46, 671 (1963). 6,232 (1964). (1963). Nawar, U'. W., Lombard, S . H., Dall, H. E. T., Ganguly, A. S., Parks, 0. W., Keeney, M., Katz, I., Schwartz, D. P., J. Lipid Res. Parks, 0. W., Keeney, M., Schwartz, D. P., J. Dairy Sci. 46,295 Parks, 0. W., Patton, S., J. Dairy Sci. 44, 1 (1961). Parks, 0. W., Schwartz, D. P., Keeney, M., Nature (London) 202, 185 (1964). patel, T. D., Calbert, H. E., Morgan, D. G., Strong, E'. M., J. DLrY Sci. 45,601 (1962). **"* rrw­ *­ Patton, S., J. Dairy Sci. 36, 1053 (1952). Patton, S., Josephson, V., Food Res. 22,316 (1957). scan la^, R A, U y , R C., Libbey. L. M., %, E A, J. Dairy schwartz, D. P., Parks, 0. W., Y o n d e , R A, J. Am. Oil Cbm. , i Stark, W., Forss. D. A, J. Dairy Res. 33,31 (1966). .1 Thomas. E. L., Burton, H., Ford, J. E., Perkin, A. C., J. Bairn ; Si. 51, 1001 (1968). Soc. 43,128 (1966). 1 Res. 42,285 (1975). ­1 Toothill, J., Thompson, S. Y., Edwards­ Webb, J.. J. Dairy R ~~. 1 4 37,29 (1970). 7 . withers, M. K., J. Chromatogr. 66,249 (1972). Zadow, J. G., BimRistle, R., J. Dairy Res. 40,169 (1973). Isolation and Identification of Volatiles from Catawba Wine Richard R. Nelson, Terry E. Acree,* and Robert M. Butts . ­ The volatile composition of three Catawba wines prepared from grapes grown in the vineyards of the New York State Agricultural Experiment Station during the 1976 vintage were analyzed by instrumental and sensory means. The three wines differed according to the enological technique employed for their production. Volatiles were isolated by solvent extraction, separated and quantified by gas chroma­ tography, arid identified by combined gas chromatography­ mass spectrometry. Although some variation in volatile composition due to processing technique was observed, sensory analyses comparing the win? with corresponding model solutions indicate that the major identifiable components are of little im­ portance in determining the aroma of Catawba wine as influenced by processing technique. 4 Catawba vines have been cultivated in the northeastern United States for over 150 years. Currently, in New York, over 10 000tons are produced annually and over 90% of that is used for wine production (New York State Crop Reporting Service, 1976). Catawba grapes can be used in the production of either white or ros6 wines depending upon enological technique, and much of the white wine produced is used in sparkling wine cuv6es. The literature dealing with the volatile composition of wines and winegrapesisextensive. Kahn (1969) and Webb and Muller (1972) have tabulated hundreds of compounds that have been identified in wines and other 'alcoholic beverages. Many native American grape varieties including Concord and Catawba have characteristic aroma components that appear to be unique to some varieties with iabrusca parentage. Although many workers (Holley et al., 1955; Neudoerffer et al., 1965; Stevens et J., 1965; and Stern et al., 1967) have studied the volatile composition of the Concord variety, no such investigations have been con­ ducted with Catawba. Methyl anthranilate, a compound long thought to be of major importance in the aroma of labrum varieties (Sale and Wilson, 19261, now appears to be far less important than previously thought (Nelson et d., 1977a). Friedman (1976) believes that methyl anthranilate is of little im­ Department of Food Science and Technologyv New Yoyk state A& ultural Experiment Station, Geneva, New Yo& 14456. ­ _­­ "­l .".1 ." .."". n*, fi portance in the aroma of Concord grapes, even though ita concentration in that variety &­ relatively high. h e h e et aL (1959) noted that the distinctive Catawba aroma was apparently not due to methyl antbrdte and that other more important compounds must be present. This report examines the volatile composition of Ca­ tawbawines prepared by three different enological techniques. In addition, it attempts to assess the effect of processing technique on the occurrence of these volatils in Catawba­ wine. MATERIALS AND METHODS Wine Preparation. Catawba grape6 were harvested at 16.6" Brix in October of 1976. The fruit was divided into three 20­ kg lots for fermentation. From one lot a white Catawba wine was prepaied by immediately pressing the 7 crushed grapes while rose wines were prepared from the other two. One of the rose wines was prepared. by fer. meriting the juice in contact with the ekins for 5 days [d (FS)] whil'e the other was thermally vin% ed [rose (m71. "hemal Mlcation comista of hating the crushed grapes in a steam kettle to 60 O C for 16 min, followed by im­ mediate pressing. Fermentations were conducted at 20 *C and other standard enological procedures as described b' Nelson et al. (1977b) were followed in each case. Volatile Isolation. The Catawba wine volatile6 were isolated using organic solvent extraction with Freon 113 (1~ 1P­ tricbloro­ 1,2,2uor~~~ e, "Precision Cleaning Agent, Du Pont"). 33qd volumes of wine and fieon (2700 &I were stirred fdr 1 h. The Freon phase was then draws bff, dried over anhydrous magne+ m sulfate, and Con­ * retention concentration, ppm time, rose rosd compound min white (TV) (FS) " ethyl acetate p ) jsobutyl acetate (c) ethyl butyrate (d) isoamyl acetate (e) isoamyl alcohol (f) ethyl hexanoate (g) hexyl acetate (h) ethyl lactate ii j n­ hexanol (j) cjs­ 3­ hexene­ 1­ 01 (k) ethyl actanoate (1) ~inaloiil (m) butyric acid (n) ybutyrolactone ' (0) ethyl Gecanoate (p) diethyl succinate (9) 2­ phenylethyl acetate (r) hexanoic acid (6) 2­ phenylethyl alcohol (t) octanoic acid (u) methyl anthranilate 3.25 6.22 6.74 9.14 11.37 12.84 14.07 16.18 16.43 17.41 19.61 23.18 24.13 25.02 26.07 27.39 31.70 32.76 33.17 38.87 46.41 0.15 0.16 0.02 0.03 0.04 0.03 i 0.17 0.12 0.09 2.57 3.19 1.68 6.27 3.19 1.68 0.57 0.49 0.47 0.04 0.13 0.20 0.17 0.24 0.45 0.34 0.12 0.76 0.06 0.03 0.13 1.16 0.74 0.55 0.02 0.05 0.10 0.04 'I" ' 0.12 ndb Tr 0.06 0.53 0.33 0.26 0.30 0.56 0.95 1.09 3.79 2.90 3.23 ­1.35 5.51 5.00 7.45 7.50 9.20 7.35 1.80 ndb 0.07 Tf 'a only trace quantity detected. Not detected. centrated in a'rotary evaporator with water bathat 20 "C. The final extract concentration was 13500­ fold (0.2 mL), md each extract had a characteristic Catawba­ like aroma while the aqueous phase was nearly odorless. Instrumental Analysis. The Catawba extracts were analyzed by combined gas chromatography­ mass spec­ trometry using 3­ pL injections. The system consisted of a Sarian Series 1400 gas chromatograph with a 4 m X 2 mm i. d. glass column packed with 10% SP­ lo00 on 100­ 120 mesh Chromosorb W. A temperature program from 60 to 200 "C at 4 "C/ min was employed. The gas chromatograph was interfaced through a LleweUyn type methyl silicone membrane separator to a Bendix Model 12 Time­ of­ Flight mass spectrometer equipped with CVC Mark IV solid state electronics and with a computerized data collection system. Spectra were taken at 70 eV and identification was done by comparison of experimental spectra with published spectra and with those of authentic standards. Comparison of component retention times with those of the authentic standards was considered to be confirmatory. Quantification of volatile components was done using a Hewlett­ Packard 5830 A gas chromatograph Chromatographic conditions were the same as above exckpt that a stainless steel column of the same dimensiow was used. Quantitative estimation was done by comparing ;the peak area of 2­ phenylethyl alcohol, a major component, with that of an internd standard (n­ decanol) added to the Freon extract at a level of 2 ppm relative to the original wine. The concentrations of the other components were then calculated directly using relative peak area ratios. Sensory Evaluation. The odors of the individpal components in the three extracts were characterized by the authors using a sniffing device (Acree'etm a]., 1976) attached to the effluent port of a Packard Model 800 gas chromatograph. Chromatographic conditions were the same as in the GC­ MS system. In order tb examine the role, if any, of the identified compounds in determining Catawba odor, model wine solutions were prepared using 12% v/ v ethanol­ 1% w/ w tartaric acid, pu; ified Concord grape anthodyanin gigmeht, and the identified volatiles in distilled water. The v& tiles Were added to the three model solutions at the level de­ termined for each compound iq the corresponding au­ t i .. I 30 40 50 RETENTION nME (MIN) Figure 1. Chromatogram of the 13500­ fold Freon extract of Catawba wine fermented in contact with the skins. tbentic wine. The concentration of each compound added to model solutions we listed in Table I. All compounds identified were added to the corresponding model solution, except when only a trace was detected none was added. To eliminate panel bias due to color differences, pigment was added to the wins and to the model solutions at levels such that each sample had a t­ ypical ros& color. An ex­ perienced 1Zmember panel completed three sets of randomized triangle. difference tests. Only odor was Considered by the panel 90 the samples were not tasted. The Catawba wines were first tested against each other, and then the model solutions were examined for aroma , differe? ces. Finally each winewas tested against its corresponding model solution. Samples were presented at room temperature in standard wine glasses in individual tasting booths. Sample size was 50 mL. RESULTS A N D DISCUSSION In the white Catawba wine, 36 compounds were present in concentrations sufficient for quantitative estimation. In the rose wine fermented in contact with the skins and in the thermally vinified ros6 wine 42 and 50 compounds were detected, respectively. Of these, 19 compounds found ­ in the white wine were identified and 21 compounds in the other two extracts were identified. Methyl anthranilate and y­ butyrolactpne were not detected in the white Ca­ tawba wine. The compounds that were identified were generally those present in the largest quantities. The ide'ntified'compounds had a total concentration that was ne+ y constant at 30.8 ppm in all three wines and rep­ res, ented' from 95.7 to 97.5% of the total extractable volatiles; F i 1 shows a chromatogram of the 13 5oO­ fold extract of the wine fermented in contact with the skins. The letters "a" through "v" correspond to the identified cornpourids listed in Table I with their concentrations in the differmt wines. The concentrations of the maj0rit. y of $he'compunds appear to be little affected by enologid. technique. However, the acetate esters, particularly isohmy1 acetate tpd 2­ phenylethyl acetate. are distinctly more +bundant in 'the thermally vinified wine. Decanoic acid (v) was identified in each of the wine extiacts but its concentrktion could not be reliably estimated due to excessivk chromatographic tailing. I!@ ii$ J~ skrongly oro ow compounds were detected by gas chrpdaxikaphip ,effluent sniffing. Some, with extremely lo? && Fent thresholds, were present in concentrations, ,, nble E. Results of Randomized Triangle Teb Comparing the Aroma of Catawba Winea and of Model Solutions correct comparison response% significance wines vs. wines ­white vs. rosh (TVIb 10 0.001 white vs. r o d (E'S)= 9 0.01 res; (TV) vs. rosd (FS) 9 0.01 white vs. r& (TV) 9 0.01 white vs. ros6 (FS) 7 NSd ro& (TV) vs. rose (FS) 9 0.01 white 11 0.001 rosi (TV) 1 2 0.001 ros6 (FS) 10 0.001 Maximum nurpber of correct responses is 12. Ther­ mally vinified rose wine. Rosd .wine fermented in con­ tact with the skins. Not significant. too low to give any detector response. No single compound was thought to have a distinctly Catawba­ like aroma.. The results of the triangle difference tests are shown in Table 11. The panel found that the aroma of each Ca­ tawba wine was significantly different from that of the other twowines (99% level'of confidenceor better). Clearly, if processing technique had no significant effect on Catawba wine aroma, further sensory investigation would be unproductive but this is apparently not the case. The panel was then asked to distinguish among the three model solutions. The aroma of the solution imitating the thermally vinified wine was significantly different from that of the other two solutions (99% level of confidence). ­. Apparently some compositional difference in the identified compounds is organoleptically significant and peculiar to the thermally vinified wine. Although proof is not yet available, the mostobviouscompounds to which this difference can be attributed are isoamyl acetate and 2­ phenyktiiyl acetate because of their high concentration in that sample. The solutions corresponding to the wine fermented in contact with the skins and the white wine were indistinguishable by the panel. This indicates that the identified compounds, even though they represent over 95% of the total extractable volatiles, do not account for the significant aroma differences that occur in Catawba wine due b processing technique. In the final triangle test each wine was judged against its corresponding, model, solution. A highly significant difference (99.9%) was found in each case. The three model solutions were, in fact, very poor imitations of the authentic wine. The high concentratiofi of acetate esters in the thermally vinified wine may contribute to its dis­. tinctive aroma but it certainly does not define that aroma. models vs. models wines vs. models . ."" ., " q *­ It appears that the identified components, although they do contribute aroma, contribute little­ or nothii to Ca. tawba varietal character as influenced by enologicd technique. The nature of wine and wine­ grape aroma is not we0 understood. Brander (1974) has suggested that e n m y the same volatile Components are present in all wine varieties and that the aroma differences ­0ng. Virietia are due to these components beiig present in differing ratios. On the other hand, Stern (1975) stresses the h­ portance to wine aroma of compounds present in trace quantities. The concentrations of these compoun& is often too low to give any detector response whataoever cment methodology, but they may be of great 0rganoIeptii importance if they have sufficiently low thresholds. The major volatile components detected and identified in the three Catawba wines do contribute aroma to those wines. However, the model solutions containing these compounds at their appropriate concentrations are easily disthguished from the authentic wine. It can be condud& that the unidentified trace components, although they comprise less than 5% of the total Freon­ extractable volatiles, are of critical importance to the aroma of Ca­ tawba wine as influenced by processing technique. LlTERATURE CITED Acree, T. E, Butts, R. M., Nelson, R. R., Lee, C. Y., Am!. Chem. 48( 12), 1821 (1976). Amerine, M. A,, Roessler, E. B., Filipello, F.,. Hifgardia 28( 1&), i 500­ 501 (1959). Brander, C. F., Am. J . Enol. Vitic. W( l), 13­ 18 (1974). I Friedman, I. E., N. Y. Hortic. SOC. Roc. 121, 132­ 136( 1976). 1 Holley. R. W., Stoyla, B., Holley, A. D., Food Res. 20.326330 I (1955). " "_ Kahn, J. H., J. Assoc. Off. Anal. Chem 52( 6), 1166­ 1123 (1% 9). Nelson, R. R., A~ ree, T­ E., Lee, C. Y., Butts, R. M., J. Food Sci. Nelson, R R, A m , T. E., Robinson, W. B., Pool, R M., Bertino, Neudoerffer, T. F., Sbdler, S., Zubeckis, E., Smith, M. D., J . New York Crop Reporting Service, Survey of Wineries and Grape . Sale, J. W., Wilson, J. B., J. Agric. Res. 33( 4), 301­ 310 (19261. Stern, D. J., Guadagni, D., Stevens, K. L, Am. J.% nol. Vitic. 26( 4). Stern, D. J., Lee, A., McFadden, R . H., Stevens, K. L., J. Agric. Stevens, K. L, McFadden, W. H., Teranishi, R., J. Food Sci. 30, Webb, A. D., Muller, C., Ado. Appl. Micro& ioZ. 15,75­ 146 (1972). 42,57­ 59 (1977a). J. J.,. N. Y. Food Life Sci. Bull. No. 66 (July 1977b). Agric. Food Chem. 13( 6), 584­ 588 (1965). Processing Plants, Albany, N. Y., 1976. 208­ 213 (1975). Food Chem. 15( 6), 1100­ 11,03 (1967). 1006­ 1007 (19651. Received for review October 25,1977. Accepted May 4,1978. Presented at the 174th. National Meetingof the American ChemicalSociety, Chicago, Ill., Aug1977. Approved by the Director of the New York State Agricultural Experiment Station as Journal Paper No. 3107. .. f ­ .~ R. R. NELSON. 1. E. ACREE, C Y. LEE and R. M. BUTTS Dept. of Foodscience & Technology New York Sfate Agricultural Experiment Station, Geneva, NY 14456 METHYL; ANTHRANILATE AS AN AROMA CONSTITUENT OF AMERICAN WINE i INTRODUCTION lf[ f` WINE INDUSTRY of the Eastern United States and Can­ s based on the native American grapes and on hybrids and rlr,­; ions thereof. Certain native grapes have a characteristic r!,,, nF flavor which is disagreeable t o many wine consumers. 1 rwrilc over 100 yr of intensive grape breeding, this "foxy" ,.& c?? s, t, r still prohibits production of European style wines from \\ h. 7 The origin of the term "foxy" and its association with the grapes I: . ._­ ­ ~ ­ Amric­ n varieties is unclear, but the most reasonable theory ,, b K d on the similarity of the wild musky odor of the grapes r: th the characteristic animal­ like odor of a fox or of a fox's dtr. The gapes, which were originally called Fox Grapes were fuflhCr subdivided into the Xorthern Fox Grapes (Viris iabrus­ r;) and the Southern Fox Grapes (Vilis rotundifolio) (Bailey, i PO8 ). Methyl anthranilate has been suggested as an important rr. mpofient of the characteristic Concord (the most important ra:: vc' American variety) aroma for over 50 yr (Power, 1921). has since been implicated as a major contributor to "foxi­ e a *' in American wines (Sale and Wilson, 1926; Winkler, f Q 7 2 ). Amerine et al. (1959), using Catawba as an example, rqgcsted that "foxy" varieties need not contain methyl mthranilate. This paper is intended to evaluate the importance of methyl 3n: hranilate as an odor constituent of wines produced from *dely differing grape varieties. MATERIALS & METHODS *Hca i( different varieties of wine were obtained from the experimental *2 z k :I ~o n of the New York State Agricultural Experiment Station for *­ w. this experiment. AU wines were prepaied according to the stan­ d *. ` rmt­ dure of Pool et al. (1976). The wines represent four snecies ( '1 T ~c wineswere extracted with Freon 11 3, concentrated, andana­ ' ­4 k r r methyl anthranilate by the gas chromatographic method of ~c !s .~t r e1 at. (1976)­ Sensory evaluation Two separate sensory analyses were performed. First, the threshold of methylanthraniiate in wine (V. viuiferu cv. WhiteRiesling) was estimated by comparing the odor of wines with varying concentrations of added methyl anthranilate. Rankings were done by the taste panel to determine the point at which methyl anthranilate could no longerbe detected. Second, an evaluation of relative foxiness in selected varieties wasperformed by the same panel. The wines were selected to vary in nature andintensity of odor and to containmethylanthranilate at various levels. This permits a direct comparison of foxiness and methyl anthranilate concentration. The sevenpanelists employed inthiswork are experienced in the critical sensory evaluation of wines. RESULTS & DISCUSSION THE THRESHOLD of methyl anthranilate in wine was esti­ mated by sensory evaluation. The panel was given clean, young White Riesling wine samples with methyl anthranilate added at various levels. The ranking was conducted in two groups of four samples each (0.00, 0.01, 0.03, 0.1 and 0.1,0.3, 1.0, 3.0 ppm). The results, shown in Table 1 , indicate that the panel could successfullf distinguish higher levels of methyl anthranil­ ate. They were, howeker, unable to correctly rank the less ' concentrated set. The threshold can be estimated from these results, Each set of four wines contained a sample with 0.1 ppm methyl anthranilate. The panelists could correctly rank this sample within the set of higher concentrations while they could not do so within the less Concentrated set. This indicates that 0.1 ppm could not actually be detected but was ranked . correctly by the process of elimination only when samples of higher concentrptipn were available for reference. The sample containing 0.3 pp, m was consistently ranked correctly so it can be assumed that this concentration of methyl anthranilate is at or near the threshold level in White Riesling wine. With this information, a mdre meaningful estimation of the importance of methyl anthranilate in wine aroma can be made. Table 1­ The threshold of methyl anthranilate in white riesling wine Methyl anthranilate (ppm) Correct rank AVQ ran@ 0.00 1 3.1 0.01 2 2.3 0.03 3 1.9 0.1 0 `4 2.7. ­ 0.10 4 4.3 0.30 5 5.3 1 .oo 6 5.9 3­ 00 7 6.6 ,a Average rank of seven experienced panelists Volume 42 (1977)­ JOURNAL OF FOOD SCIENCE­ 57 . ... ~~ ~ ~~~­~ ~ f "JCIlJRNAL OF FOOD SCIENCE­ Volume 42 (? Y// J The majority of the 45 varieties analyzed were found to be ; free of methyl anthranilate. Table 2 fists these varieties, their parentages, and the vintage of each sample. Only six varieties 3. Additional samples of Niagara, Concord and Delaware were (? ' analyzed and considerable variation in the level of methyl anthranilate due .to vintage and enological technique was found. In 1949, Robinson et al. reported that methyl anthra­ nilate was formed in grapes during the final stages of ripening. sample was harvested at 16.0° B and showed 3.1 ppm methyl t i 9 % were found to contain methyl anthranilate as shown in Table L %,/ i This certainly seems to b e t h e case for Niagara. The 1970 i !4 1 ' Table 2­ Wine varieties without methyl anthranilate Variety Vintage ­ French hybrid9 Aurore (5.788 X 5.29) Baco 22A (Folle blanche X Noah) Chancellor (S. 5163 X S. 880) Chelois (S. 5163 X s. 5593) OeChaunacb 6.51 63 x S. 793) Fochb (Mgt. 101­ 14 X Gold Riesling) b n d o t 451 1 (L244 X S. V. 12­ 375) Ravat 51 (5.6095 X Pinot blanc) S e i b e l 10868 6.5163 X 5.5593) Geneva hybrids Canada Muscat Cayuga White GW­ 1 (Catawba. X Seneca) i/.;..., ?, GW­ 2 (Seyval X Schuylerl I GW­ 4 (SeyvaI X Sene= ') L T GW­ 5 (Pinot Blanc X Ontario) ~ GW­ 6 (S e y ~l X Seneca) GW­ 7 fSeywI X Schuyler) GW­ 8 (Pinot Blanc X Aurore) GW­ 10 (SeyvaI X Chardonnay) GR­ 1 (Buffalo X Baco Noir) GR­ 3 (Buffalo X Baoo Noir) GR­ 6 (Buffalo .x Baco Noir) GR­ 7 (Buffalo, X Baco Noir) N. Y. Muscat Vitis aestivalis Wild Summer Vir;$ labrusca (and crosses) Diamond 1970 1972 1969 1970 1970 1973 1970 1973 1973 1969 1974 1970 ~ 1967 1967 1971 1967 1968 anthranilate while the 1975 sample matured to only 12­ 50 and showed 0.6 ppm. , Of the six varieties containing methyl anthranilate, Catau ba, Delaware and Elvira may have'insufficient methyl anthr nilate to influence the aroma of these wines since the COncel trations determined are near the threshold level. These wine however, are decidedly American in character. A wide range of native American wines are called "fox) but methyl anthranilate appears t o be important in only a fe of them. In order to examine the correlation of "foxiness with methyl anthranilate concentration, a series of wines w; selected for further taste panel work. The: wines were selected to have a wide. range of apparer foxiness and to subject the panelists to other varietal aromi that may or may not be considered foxy by the individu judges. The six varieties selected were. Canada Muscat, Carlo Concord, Moored, Niagara and White Riesling. A seventh sari ple was prepared by adding 0.7 ppm methyl anthranilare t the same White Riesling wine. In the experiment panelists we1 asked to smell the wines and rank them according to decrea ing foxiness. The results are shown in Table 4. There appeal to be no correlation between methyl anthranilate concentr; tion and the relative foxiness of these wines. The fact that the White Riesling sample with 0.7 p p ~ added methyl anthranilate was ranked higher in foxiness tha the pure Riesling may indicate that the ester makes some cor tribution to the foxy character. However, other varieties wit less methyl anthranilate were consistently judged higher in thl character. In fact, three of the four wines judged highest i Table 3­ Wine varieties with methyl anthranilate Methyl anthranilate V a r i e t y V i n t a g e Parentage bpm) 1972 Niagara 1970 V. labrusca 1972 Concord. 1970 V. labrusca 1 967 Concord 1975 V. Iabrusca 1972 Concord 1972 V. labrusca 1972 Niagara 1975 V. labrusca . 1973 lves 1972 . V. labrusca 1969 Catawba 1972 V. Iabrusca X ? 3.102 1.752 1 .110 0.699 0.61 7 0.381 0.1 78 Delewaren 1975 , V. labrusca X ? 0.102 Elvira . 1972 V. labrusca X V. riparia trace Oelaware 1973 V. iebrusca X ? 0. M) O " a Hot pressedsamples . 1970 1966 Dutchess 1967 Eumelan 1967 lsabella . ­ 1966 Moored 1975 Table 4­ Evaluation of "'foxiness" in selected varietal wines Vincent . 1970 Methyl Vitis rotundifolia nnthranilate Carlos 1974 Variety foxiness' . . , fppml Fry 1974 Hunt 1974 Carlos 5.1 ' 0.0 I Concord 49 1.7 ­ Canada Muscat 4 ­4 Pinot Blanc 1971 0.0 Moored Pinot Blanc 4.1 1972 0.0 A: 1 ..­\ Sylvaner Niagara 1973 3.7 0.6 Rieslingb 3.3 White Riesling 1972 Riesling 2.4 0.0 0.7 Vitis vinifera :r ­ i ", ._ a Seedling abbreviations; S = Seibel; Mgt. = Millardet et de Grasset; a Rank averages, seventasfers on a seven point scale bHot pressed samples L = Lendot; S. V. = Seyve­ Villard, . . . . Methyl anthranilate added (0.7 ppm) using standard solution in EtOH ­ .. ­I,, .. .. .­ , . ­ .. ataw­ * inthra­ , oncen. win?­ . 4 rhb &Some "foxy" wine varieties frm of methyl snttiranilstr ­­­" Variety Parantap d WiW Omda Muscat V. vinifera X V. labrusce Carlos V. rotundifofia Diamond labrusca X ? outchess V. labrusca X 7 FrY V. rotundifolia M, wouri Riesling V. labrusca X V. riparia Eumetan V. aestivalis tabella V. labrusca Moored V. labrusca (hybrid) N. y. Muscat V. vinifera X V. labrusca vtncent V. labrusca (hybrid) R d foxiness were entirely free of methyl anthranilate including Carlos which was rated the most foxy of all wines tested. The case of Carlos (a bronze variety of the muscadine grape, I? rc, rundifoliu according to Ferree, 1975) is not unique. Table 5 lists several more varieties, both red and white, of various par­ entages that are generally considered t o produce foxy wines and art' free of methyl anthranilate a t levels determined in this work. CONCLUSIONS METHYL ANTHRANILATE occurs with relative infrequency in wine varieties. It is limited to some varieties of V. hbrusca and a few crosses thereof. In addition, the concenlration methyl anthranilate present in many cases appears lo be bel the threshdld level which furlher minimizes its importance win e. aroma. If present in large quantities, as in some samples of Concc and Niagara wines, methyl anthranilate prohahly contribu to the characteristic "grapey" or "fruity" aroma­ of thc wines. However, any correlation of methyl anthranilate wi foxiness seems to be absent. It cannot he said that mett anthranilate does not contribute t o foxiness but it is clear t h it is not the primary source of the odor. Unlike the occuren of methyl anthranilate, foxiness is not limited to varieties K . lahrusca but is found in a wide range of native Americ. wines of dissimilar parentage. Further analytical ­and sensory work yifl be required determine the cause of the native American wine aron known as foxiness. REFERENCES Amerine, h1. A.. Roesrler, E. B. and Filipello. F. 1959. Modern sensol methods of evaluating wine. Hilgardia 28: 477. Bailey, L. H. 1898. "The Evolution of our Native Fruits." The Ma millan Co.. New York. Ferree. M. E; 1975, Muscadine grape culture. Bull. 739. Univ. of G, Nelson. R. R.. Aeree, T. E.. Lee, C. Y. and Butts, R. M. 1976. Gas­ liqui CoL of A&, Athens. Ga chomatographic determination of methyl anthranilate in win1 JAOAC. In pres Pool. R. M.. Robinson. W. B.. Einset. J., Kimball. K. H.. Watson J. P. an Bertino, J. J. 1976. Vineyard and cellar notes 1958­ 197a. Specis Power, F. B. 1921. The Detection of Methyl Anthranilate in Fmi Report No. 22.. N. Y. St. Ag. Exp. Sa.. Geneva. N. Y. Juices J. Amer. Chem. SOC. 43: 377. Robinson. W. B.. Shaulis. N. J. and Pederson, C. S. 1949. Ripenin Studies of Grapes Grown in 1948 for Juice Manufacture. .Fruit Prod J. and A m Food Mfg. 29( 2): 36. 'Sa'e. J. WI and Wilson. J. B. 1926. Distribution of voIatile flavors L Winkler. A. J. 1972. ''General Viticulture." University of Caliiorni; grapes and grape juices J. Agr. R e s 33: 301. hfs received 6/ 2/ 76; revised 7/ 9/ 76; accepted 1/ 16/ 16. bess. Berkeley. Calif. iNHERITANCE OF METHYL ANTHRANILATE AND TOTAL A. G. Reynolds, T. Fuleki, and W. D. Evans Respectivelyformergraduatestudent. Department of HorticulturalScience. University of Guelph. Guelph, Ontario. Canada N1G 2W1; Research Scientist, Horticultural Products Laborato­ ry. Horticultural Research Institute of Ontario, Vineland Station, Ontario LOR 2EO; and Associate Professor, Department of Horticultural Science, University of Guelph. Mr. Reynolds is currently pursuing further graduate study in the Department of Pomology and Viticulture, New York State Agricultural Experiment Station, Cornell University, Geneva, New York 14456. Taken in part from the MSc Thesis of the senisr author. Thesenior authorwishes to thank Dr. R. E. Subden, Department of Botany and Genetics, University of Guelph, forhisencouragementandguidancethroughoutthecourse of this work. Presented at the Fifth Annual Meeting of the Eastern Section, American Society of Enologists, August 8. 1980. Erie, Pennsylvania. Financial Assistance from the Natural Sciences and Engineering Research Council of Canada is gratefully acknowledged. Manuscript 25 May 1981 , Revised manuscript received 2 November 1981. Accepted for publication 7 November 1981. ABSTRACT Methyl anthranilate and total volatile esters concen­ trations were determined for two families of grape ' seedlings which resulted from crosses made at Vineland, Ontario in 1972. Chi­ square analysis of the segregation patterns suggested that three dominant complementary genes were involved in the inheritance of methyl anth­ ,., c­ ~ ranilate and two for total volatile esters. High heterosis r\. j and broadsense heritability values for both characters In Ontario, ,grapes are grown on approximately 10000 ha, about half of which are still planted to the traditional Vitis labruscana cultivars. Improvement of the Ontario grape and wine industry to allow it a greater competitiveness domestically has involved both the planting of French hybrid and V. uinifera cultivars, and the introduction of new wine­ grape cultivars from grape breeding programs such as that of the Horticultural ' Research Institute of Ontario a t Vineland Station, On­ tario. This latter breeding program has, as one of its, objectives, the elimination of the undesirable "foxy" or labrusca flavor character from its select, ions; however, due to the climatic constraints of the area, the objectives of winter hardiness, disease resistance, and vigor often ' take precedence over this objective, such that the utili­ ' zation of labrusca­ flavored but hardy cultivars as par­ en'ts is often necessary. Because of this problem, this study was initiated, to elucidate a mode of inheritance for the labrusca flavor charact. er, and to make recom­ mendations for its avoidance in wine­ grape breeding programs. dyid' ~ . .. An early reference to "foxiness" in grapes was made ;: by Hedrick et al. (9), who described the aroma of certain /­,; ' V­ labruscana cultivars as being reminiscent of a fox's den or­ burrow. Early attempts to characterize this flavor Liq;/ j chemically' were reported by Power and Chesnut (Is), ,II I l l suggested dominance. Statistical differences between the families and examination of the ancestries of the parental cultivars allowed the postulation of genotypic formulae for the parents. No correlation wasfound between methyi anthranilate and volatile esters, or among either of these characters and soluble solids, winter hardiness, or vigor. . " .­ ?' .; , who found a relationship between labrusca flavor char­ acter, V. labrusca ancestry, and the ester methyl anth­ ranilate (MA). Sale and Wilson (18) reported similar results, but indicated that other volatile esters such as ethyl acetate also made an important contribution to the flavor. Ho'lley et al. (11) detected eight components in the essence of Concord juice, of .. which MA, methyl acetate, and ethyl acetate were predominant. They concluded, however, that many other important aroma­ tic substances were probably overlooked due to the iimitation of their methods. The development of gas chromatography has allowed much more sophisticated and detailed investigations int. 0 the volatile composition of fruit crops. Neudoerffer et al. (13) identified 32 compounds in Concord essence using gas chromat. ography: Methyl anthranilate was not detected because it did not elute from the column. Similar, but less extensive was the list of Stevens et al. (201, who, $sing gas­ liquid chromatography­ mass spec­ trometry, sugg, ested methyl­ 3­ buten­ 2­ 01 to be of great significance, along with ethyl acetate. Sixty components of Concord essence were detected by gaschromato­ graphy­ mass spectrometry by Stern et a/: (191, of which a series of crotonate esters and an alkylthioester were viewed as being important, as well as ethyl acetat. e, MA, and several other esters. For the facilitation of' selection of non­" foxy" culti­ 14 ',; I Am. J. Enol. Vitic., Vot. 33, No. 1, 1982 in the wine­ grape breeding program in Ontario, ;r7.­.>, Li (6, r) has devised an index for t. he labrusca flavor acter based on the concentration of MA and total ,,, latile esters (T\ 'E) in the fruit. This score, known as \'ineland Grape Flavor Index (VGFI), has intro­ dltced a high degree of speed and objectivity into the celec'ti() n process. The derivat. ion of this index was based i,,, the high correlation between labrusca flavor charac­ ter M A and TVE concentration. The inheritance of specific flavor characters in Craps. most notably muscat flavor, have been investi­ Pa ted by a number of European researchers .i n . V. l .i ,l i f p m . Wagner (231, using organoleptic evaluation, ,tlggel; ted t h a t a t least five dominant complementary plies were involved in muscat flavor inheritance. Tsek­ nlislrenk<> and Filinova (22), considered the character to be monogenic and dominant. M'agner et ai. (24) p0st. u­ laled a, mechanism for muscat flavor inheritance based o n the heritability of the five major terpenes normally Ihought to comprise the flavor. It was found that four of the five were inherited identically via a two­ gene system, ahereas the fifth. linaloijl, possessed a more complex inheritanre. Later studies (25,26) part. ially refuted t. his hypothesis, by indicating a correlation between terpenes previously thought to be unrelated, and a lack ofcorrela­ titm between terpene concentration and intensity of muscat flavor as perceived organoleptically. .­ .. Genetic investigations into the labrusca flavor char­ " ': have not been previously carried out. The objec­ " of this research were to elucidate a mode of mdritance for the labrusca flavor charact. er based on 31.4 and TV­ E content, and to make recommen'dations on its minimization in wine­ grape breeding programs. MATERIALS AND METHODS Ayailable genet. ic material: All mat. eria1 for our investigations was grown and harvested at. the Grape Research Station, Vineland, Ontario. Cultural methods were carried out according to Ontario recommendations (141, and those of Bradt( 1). Two­ families of seedlings, namely V. 7218 and V. 7219 were chosen for investigation, tn, th ofwhich were the result of the hybridization of one high­ and one low­ VGFl parent carried out a t Vineland in 1972. Such a parentage maximized t. he probability of ohraining a significant number of non­ labrusca and !at) rusca­ flavored seedlings in the progenies. Family V. 7218 was a cross between V. 5407i (de Chapnac X Concord, Yineland 1954; MA = 0.14 ppm, TVE = 21 ppm) and Bertille­ Seyve 5563 (S. 6905 X B. S. :U­ 4% M A = nil, TVE = 3 ppm). A total of 229 seedlings wab available in the autumn of 1978. Family V. 7219 was a cross between V. 54077 and V. 50061 (Alden X Lo­ manto, Vineland 1950; hlA = nil, TVE = I pprn). In the autumn of 1978, 226 seedlings were available in this family. Fifty seedlings were chosen randomly from each fa2 ,. '.. for our investigations. of vigor and hardiness: In May, 1978, ne^ in both families were rated on a scale of 0 to 4 r( k vigor and wint. er hardiness. For vigor, shoot length and number constituted the criterion for the rating, Uihere ''4'' represented the most vigorous. I n assessing METHYL ANTHRANILATE ­ 15 winter hardiness, the amount of killed buds was consid­ ered such that a rating of "0" indicated the hardiest vine. H a r v e s t i n g a n d s t o r a g e : M a n y s t u d i e s (3,4,15,17,18) have indicat. ed t. bal MA concentration increases with advancing fruit mat. urit. y, and decreases somewhat as the fruit becomes overripe. It was thus imperative to harvest each seedling at it. s optimum maturit. g. To accomplish. this, preharvest checks were initiated on September 1, 1978, and were continued twice weekly until all fruit was harvested. The fruit was considered ripe if the soluble solids content attained 20" Brix or greater, or was t. he same for three consecutive sampling dates, as measured by a hand refractometer. Harvesting took place between September 15 and Oct­ o­. ber 18, 1978. Once the fruit of each genotype was harvested, it was placed in a plastic bag and transported to the Biochem­ istry Laboratory, Department. of Horticultural Science, University of Guelph. Each sample was then washed, . destemmed, and replaced int. o its bag. Subsequent st. or­ age t. ook place at ­31OC. Sample preparation: Each sample was ground in a hand mill, and 50 g of the homogenate was steam­ distilled (SGA Scientific, Bloomfield, N. J. No. JD­ 2115) until 100 mL of distillate was collected. This procedure was duplicated for each genotype. A 50 mL beaker of the homogenate was also retained for subsequent soluble solids determination using an­ Abbe­ type refractornet. er. Methyl anthranilate determination: The determi­ nation of MA concentration was done according to the . fluorometric procedure of Casimir et d l . (2).. Fluoromet­ ric determination was carried out on a Turner Model 110 fluorometer (G . K. Turner ASSOC., Palo Alto, Calif.) equipped with an attachment for accepting glass cu­ vettes. A narrow pass­ (360 nm) and a sharp cut­ (415 nm) filter served as primary and secondary filters re­ spectively. Sample fluorometric readings were related to hlA concentration through the use of st. andard curves. using a series of aqueous MA solutions that ranged in concentrat. ion from 0.05 to 10 ppm. Total volatile esters' determination: The det. ermi­ nation of TVE concentration was carried out by Hill's method (10) as described by Thompson (21). Spectro­ photometric determination was done using a Coleman Junior I1 Model 6/ 20 spectrophotomet. er (Coleman In­ struments, Maywood, Ill.) set. at a wavelength of 540 nm. Absorbance was related to TVE concentrat. ion by the use of standard curves, using a series of aqueous ethyl acetate solut. ions that ranged in concent, ration­ from 0 to 125 ppm. RESULTS AND DISCUSSION Variability within families: The variability en­ countered within the families was . great, but specific patterns were nonetheless existent. Hist. ograms (Figs. 1 and 2) relating seedling frequency and MA or TVE concentration illustrate this variability, suggesting an absence of simple Mendelian inheritance in either sys­ tem. The lack of a normal distribution in t. he data also suggested that. a typical polygenic system was also not Am .I Fnol Vitir 16 ­ METHYL ANTHRANILATE .. ­f 0 V. 7219 SEEDLING CLASS PPm M A x 100 Fig. 1. Distribution of seedlings in families V. 7218 and V. 7219 according to their methyl anthranilate concentration. 40. > V 2 Y V. 7218 V. 7219 SEEDLING CLASS ppm TVE Fig. 2. Distribution of seedlings in families V. 7218 and V. 7219 according to their volatile esters concentration. present. Most noticeable vias a distinct. bimodal distribution which could be observed for both characters in each family, whereby the majority of seedlings lag to the extreme left as one group, and the others were scattered to the right. in a less homogeneous group. This distribu­ tion conveniently placed the seedlings into one of two categories, that of labrusca" or "non­ labrusca", in terms of MA and TVE. The line of demarcation bet. ween the two categories for M A appeared to be close to 0.10 ppm (Fig. 11, a value suggested by Nelson et al. (13) as being the compound7s organoleptic threshold in wine. For TVE, the point of delineation bet. ween the two classes was found to be about 12 ppm (Fig. 2), a level suggested by Fuleki (5) as being that. where labrusca flavor be­ comes noticeable organoleptically. Number of genes involved After placement of the seedlings into either the %on­ labrusca'' or "labrusca" ,/ ' class i n terms of MA and TVE. the data were subjected to Chi­ square goodness­ of­ fit tests. Table 1 indicates, faF MA, the ratios were 5: 3 and i :l for families V. 7218 and Y. 7219 respectively. These ratios corresponded with a hypothesis o f t hre. e dominant complementary genes for t. he inheritance of this compound. The large variation io MA concentration in the "labrusca" class could be at. trib­ uted to modifier genes, an explanation offered by Wag. ner (231, for the control of muscat flavor. The year­ to. year variation in the concentration of MA (and TVE well) inmost V. labruscana cultivars could also be explained by modifier genes. Table 1. Chi­ square goodness of fit analysis of methyl anthranila; concentration in families V. 7218 and V. 72193 FamilyNon­ labruscab Labruscac Ratio P ­ ObservedExpectedObservedExpected V. 7218 32 31.25 18 18.75 5 3 .80­. 9< V. 7219 44 43.75 6 6.25 7: l .90­. 95 a Observedand expected valuesarebased on a sample of 50 b Methyl anthranilate concentration = 0 to 0.1 ppm. c Methyl anthranilate concentration = 0.1 ppm or higher. ­ seedlmgs. In the case of TVE, 5: 3 ratios were obtained for both families (Table 2). These corresponded in simplest t. erms to a hypothesis of two dominant complementq genes for the control of this group of compounds. As previously indicated for MA, modifier genes were likely responsible for the. large variation in TVE concent. ration ­ in the "labrusca" class. Table 2. Chi­ square goodness of ftt analysis for total volatile ester; concentration in familiesV. 7218andV. 7219a . ` Famity Non­ IabruscabLabruscac Ratio P ObservedExpectedObservedExpected V. 7218 31 31.25 19 18.75 ­513 .90­. 95 V. 7219 32 31.25 18 18.75 5: 3 .80­. 90 a Observed and expected valuesarebased on a sample of 50 b Total volatile esters concentration'= 0 to 12 ppm. c Total volatile esters concenfration = 12 pprn or higher. It must be stressed that these dat. a possess some degree of weakness due to the small sample sizes. Other rat, ios teg. 3: l or 9 7 ) are possible, although not as statistically acceptable. Insofar as gene nomenclature is concerned, three genes, henceforth designated as M, A, and F, are sug gest. ed for the synt. hesis of hlA in grapes. Seedlings in the "labruscar class, which. were characterized by rela­ tively high hfA concentrations, could logically result from all three loci being in the dominant condition. The "non­ labrusca" class contained seedlings either with no MA or with concentrations less than 0.10 ppm. Those cont. aining no MA whatsoever would have recessiveness at all three loci, whereas those containing minute amounts of the compound could have at least one dominant locus. In the case of TVE, two genes, designated as V and E. are suggest. ed for volatile ester synthesis in grapes. A seedling possessing both genes in the dominant condi­ tion would be one characteristic of the "labrusca" class: seedlings. Am. 4. Enol. Vitic., Vol. 33, No. I , 1982 Heterosis = ­ x 100 F1 F, + P, ,,­ here F, is the averagcvalue of a particular character in the F, generation and P, is the midparent value for that. The high values displayed for both hk4 and T\ 'E i i the two families suggested that dominant genes were most likely present (Table 3). &e 3. Transgressive segregation (heterosis) of methyl anthranilate a, s total volatile esters over the parental cultivars In families V. 7218 and V. 7219 "­ f a d y Heterosis (0. b) Methyl Total volatile anthranilate v 7218 491.4 65.0 \' 7219 55.7 ­65.5 .­ i (i : High broadsense heritability (h') has also been impli­ : cated as a criterion for dominance. It is expressed as the percentage of the total variance of a progeny that can be 1. attributed to genotype, and can be summarized in the 1. following formula: z 0, ' 3 ff, ' + 4 2 .. 4 hz = x 100 I where o­ i is variance due to genot. ype and u: is variance i due to environment. The quantity u: was broken down I ­ into ua and c;,? which represent variance found between duplicate samples wit. hin a genotype and variance due to error respectively. An estimate of the u,", values for MA i and TYE were obtained from an analysis of variance of i 51.4 and TVE concentrations in several 1, '. labruscana cultivars over a nine­ year period. The u3 values were t ohtained from a one­ way model LI analysis of variance of '. each family. 1 .. The h2 values for both characters viere relatively high * In both families (Table 4), with the exception of that. for 2 ,It.\ infarn'ily V. 7219. Such information uas evidence i .'that dominant. genes were present. t I t 8 ­ . Ta% 4. Variance components and broadsense heritability of methyl anthranilate and total volatile esters in families V. 7218 and V. 721ga . L ,>_ .z I Character 4 I , 3rnnlly METHYL ANTHRANILATE ­ 17 Parental genotypic formulae: The compilation of information previously reported here and the consider­ ation of the ancestrx of the parental cultivars allowed the postulation of genotypic formulae for the parents. Since the seed parent V. 5407i was common for the two families. any statistical differences between the families were attributable t. o the pollen parents B S 5563 and Y. 50061. Basic stat. istics such as mean and variance indicated large differences between the families in terms of hfA and TVE (data not shown). Further statistical analysis examining coefficients of variation and equalit_ v of variances confirmed these differences, and strongly suggested t. hat the pollen parents were not the same genotypically, at., least in terms of MA (Tables 5 and 6). Table 5. Coefficients of variation formethylanthranilateand total volatile esters concentration in families V. 7218 and V. 7219. Family Character Methyl anthranilateTotalvolatileesters . V .7 2 1 8 5 7 3 .4 8 V. 7219 3336.62 27.93 5622.44 Table 6. Equality of variancesformethylanthranilateand total volatile esters in families V. 7218 and V. 7219. Character Methyl anthranilate 24.87" Total volatile esters 2.0342' * p = 0.05 ** p = 0.01 .­ ­ With this in mind, genotypic formulae. were 'esta6­ lished for the parental cultivars in terms of MA and TYE. A collation of the information from the Chi­ square t. ests (Tables 1 and 21, the statistical analysis (Tables 5 and 61, and the ancest. ry of the parental cultivars (16) . provided the basis for this. With consideration to MA in family V. 7218, it is suggested that V. 54077 (MA = 0.14 ppm) is of the genotype MmAaFf, while B. S. 5563 (MA = nil) is MM. 4aff or any similar genotype cont. aining a homozygous dominant, a heterozygous, and a recessive . . locus. For family V. 7219, V. 54077 is as previously noted, while V. 50061 (MA = nil) is rnrnaaff. If one examines the ancestries of these cultivars, these genotypic formulae can be qualified. The cultivar V­ 54O'ii is a cross between Concord, probably a pure t'. labrusca cultivar (and likely a homozygote in terms of . MA and TVE), and de Chaunac, whose background is V. labrusca­ free for OUT generations, (and is likely ti, be a homozygous recessive). An F, progeny which is heterozy­ gous at all three loci is thus probable. For B. S. 5563, the parents are both French hybrids, but the pollen parent, B. S. 34­ 45, has the V. lhbruscana cuhivar Othello as a 1 ~~ ~. ~~~ ~~ ~ ~­ .~ . . ~ ~~ ~ ~ " ~~ ­~ ~ 18 ­ METHYL ANTHRANILATE grandparent (8 ). Some dominant loci for this cultivar are very possible in light of this informatinn, despite the fact that i t contains no measurable M A . The cultivar V. 50061 does have some V. labrusca in its ancest. ry, but no high MA o r TVE seedlings were observed in the family from which it was selected (Fuleki. personal communication), so a completely recessive genotype is justifiahle when considering t. his fact. The genotypic formulae are also consistent with the segregation ratios obt. ained (Tables 1 and 2 ) and the information derived from Tables 5 and 6. Using this same logic. i t is suggest. ed that, for TVE in family V. 7218, V. 54077 (TVE = 21 ppm) is of the genotype VuEe, while B. S. 5563 (TVE = 3 ppm) is Vuee o r w E c . For V. 7219, V. 54077 would b, e the same as just indicated, while V. 50061 (WE = 1 ppm) would have a similar genotype to B. S. 5563. The significant F­ value in Table 6 suggests that these two pollen parents may be genotypically different to some degree. Correlation between these and other characters: Regression analysis indicated that concentrations of MA and TVE were not correlated in any way (data not shown). A significant r? value of 0.6780 for family V. 7219 could be explained by outliers in the data. Neither character could be correlated with "Brix either, al­ though the misconception is still present that cultivars of labrusca flavor character are consistently low­ OBrix, high­ acid t. ypes. A correlation could also not be found between either flavor component .and vigor of winter hardiness (data not shown); this too has oft. en been the concern of many grape breeders, who have felt. that selections with labrusca character are the most vigorous and most winter­ hardy. CONCLUSIO~ S Our results have shown that the labrusca flavor character is a complex one genetically, involving five dominant complementary genes plus modifiers. It must be pointed out that this is still an oversimplification, since many other compounds are likely responsible for this flaklor character. From a plant. breeding strindpoint, it is a difficult trait to breed against. Knowledge of the ancestry of the potential parental cultivars, coupled with efficient selection technigues (such as the utilization of the VGFI) appear to be effective weapons in combatting this problem. This study was enrisioned as being a preliminary invest. igation which could provide a base for further st. udy on the genetics of labrusca flavor. The study was 1imit. ed by the lack of availability of entirely adequat. e genetic mat. eria1. Future researchers in this area would do well to hybridize cultivars extremely rich in both MA and TVE with V. vinifera cultivars, which contain none of the former compound and little of the latter. The segregation ratios obtained from such crosses should yield valuable information. The examination of prog­ enies from selfed high­ VGFI cultivars should also be of great interest. Finally, much work is still required on the biosynthe­ sis of MA, TVE, and other flavor compounds in grapes. Nnt u n t i l more details are provided on the biochemical aspects of these flavor constituents w i l l the genetics of grape flavors be comp1et. ely elucidated. LITERATURE ClTED I . Rradt, 0. A. The grape in Ontario. Ont. Min. Agrir. Food 2. Casimir. D. .J.. d: C. hhyer. and L. R. Mattick. Fluorometric determination of methyl anthranilate in C~ ncord grape juice. J. A. O. A. C. 59: 269­ 72 (1976). Puhl. 467 (1972). 3. Clore. 1%. J.. A. M. Neuberl, G . H. tarter, D. W. Ingalsbe, and V. P. Brummnnd. composition of Washington­ produced Con. cord grapes and juices. Wash. Agric. Expt. Sta. Tech. Bull. 48 (19651. 4. Fuleki. T. Changes in the chemical composition of Concord grapes grown in Ontario during ripening in the 19'70 season. Can. J. Plant Sci. 52: 863­ 7 (1972). 5. Fuleki. T. Methyl anthranilat. e, volatile esters, and antho. cvanin content of grape varieties­ grown in Ontario. Can. Hort, Council: Report of the Cmt. e. on Hort Res. 153 (19741. 6. Fuleki. T. A new objective index for the earl? screening of grape seedlings based on flavor character. Can. Hort. Council: Report of the Cmte. on Hort. Res. 179­ 80 (1975). 7. Fuleki. T. Vineland Grape Flavor index ­ a new objective measure for the early screening of grape seedlings based on flavor character. Can. Hort. Council: Report of the Cmte. on Hort. Res. 1E2­ 3 (1976). . 8. Galet. P. Precis d'Ampelographie Pratique. Tome H I . De. 9. Hedrick. t'. P., N. 0. Booth. 0. M. Taylor. R. Wellington. han, hlonrpellier (1976). ­ and M. J. Dome?. The Grapes of New York. Fifteenth Ann. Report, : X. T. S. Agric. Expt. Sta., Vol. 3, Part 11. .J. B. Lyon, Albany. N. Y.! (1908). 10. Hill. Lj. T. Colorimetric determination of fatty acids and 11. Holley. R. W., B. Stoyla, and A. D. Hollev. The identifica­ 'esters. Ind. Eng. Chem. (Anal. Ed.) 1fX17­ 9 (19461. tion of some volatile constituents of Concord grape juice. Food Res. 2@ 326­ 31 (19.55). 12. h'elson. R. R., T. E. Acree, C. Y. Lee. and R. M. Butts. hfethyl anthranilate as an aroma constituent in American wine. J. Food Sci. 4257­ 9 (19i7). 13. Xeudoerffer, T. S., S. Sandler, E. Zubeckis, and M. D. Smith. Detection of an undesirable anomaly in Concord grape by gas chromatography. J. Agric. Food Chem. 13584­ 8 (1965). 14. Ontario Crop Protection Committee. Fruit Production Rec­ ommendations: Ont. Min. Agric. and Food Publ. 360 (1980). 15. .Power, F. B.. and V. K. Chesnut. Examination of authentic grape juices for methyl anthrani1at. e. J. Agric. Res. 23: 47­ 53 (1923). 16. Reynolds. A. G. The inheritance of methyl anthranilate and total volatile esters in Vitis spp. MSc Thesis. Univ. of Guelph, Guelph. Ontario (1980). 13. Robinson. W. B., N. J. Shaulis, and C. S. Pederson. Ripening studies ofgrapes grown in 1948 for juice manufacture. Fruit Prod. J. and Amer. Food Manuf. 29( 2): 36­ 7 (19491.. 18. Sale. J. W.. and J. B. N'ilson. Distribution of volatile flavor in grapes and grape juices. J. Agric. Res. 33: 301­ 10 (1926). 19. Stern, D. J., A. Lee, W . H. McFadden, and K. L. Stevens. Volatiles from grapes ­ identification of volatiles from Concord essence. J. Agric. Food Chem. 151100­ 3 (19671. 20. Stevens. K. L., A. Lee, W. H. hlcFadden. and X. Teranishi. yolatiles from grapes. I. Some volatiles from Concord essence. J. Food Sci. 3 0 1106­ 5 (1965). Am. J. Enol. 'Vitic.. Vol. 33, No. 1, 1982 METHYL ANTHRANILATE ­ 19 descendance de Vilis tini/ rra. Colloque C. N. R. S. 'Facteurs et Regulation de la Maturiti. des Fruits.": 335­ 9 11974). . 25. Wagner. R., N. Dirninger, V. Fuchs, and A. Rronner. Study of the intervariet. al differences in the concentration of volatile constituents (linalool and geraniol) in the arnrna of the grape. Interest of such analyses for the appreciation of the quality of the harvest. Int. Symp. Qual. Vintage: 137­ 42 (1977). cw2 26. Wagner. R., N. Dirninger, V. Fuchs. and A. Bonner. Premiers resultats concernant ]'etude gPn6tique de ronstifuants volatils im­ portants de l'irome des raisins­ dans deux descendances de Vitis L! inift= ra L. I P Symp. CbnPtique AmClior. Vigne: 419­ 34 (1978). Am. J. Enol. Vitic., Vol. 33, No. 1, 1982 1024. :E programmed to 165'C at 2" C/ min, with a helium gas flow of 5ml/ min withoutsplitting. % 5 .: and the total ion trace wasrecorded at 20 eV, whilst the mass spectra were run at 70 eV and 50 p ~, s tea stair The technique5­ 6 did not employ an internal standard. Sel del= 2.4. Identification of components const The compoundswere identified by comparison of their g. c. retentim times and mas spectra with I more those of commercial samples and with those reported by other authors.*+* prese i. . injector valve temperature was 220° C. The separator and m. s. s~ nce were maintained at 2 6 0 %~ 1 four I I .__ .. .. ­ .... 4­ .. i 3. Results and discussion The compounds identifipd are listed in Table I , together with the number of the chromatographic peak in which each was found. The relative amounts in the headspms of new and aged wine can Table 1. Compounds identified in red wine heafspace Identification Peak no. Formula Component Rcfernce r. t. ms. i CH40 Methanol 1 CZH~ O Ethanol 1 X C3H a 0 n­ Propanol I CiHpO i­ Propanol I CCHaOz E t h y l a c e t a t e 1 X CsHmOz n ­P r o p y l a c e t a t e 1 x . CSHIOOZ ­i ­P r o p y l a c e t a t e 1 X C6H1202 Ethyl n­ butyrate 1 X C: H1402 Ethyl i­ valerate . I X CeHs Indene . 1 .x X 3 C6HltO n­ Hexanal 1­ X C7H1402 . i­ Pentyl acetate I X 4 CsHlzO 3­ Methyl­ I­ butanol I ­ x X CsHlzO 2­ Methyl­ I­ butanol 1 X 5 CaHlsOz . Ethyl caproate ­. 1 X X X :­ 2 C4H 100 3" ethyl­ I­ propanol 1 ­ x . X X X X X X X X X 6 CeHlsOz n­ Hexyl acetate 1 8 C5Hl003 E t h y l l a c t a t e I 9 CsH14O I Hexanol .. I X .. 7 C; HloOz t­< Ethoxymethyl) furaa X C6H 1 2 0 trans­ 3­ Hexeno I X X CsH 1 2 0 I1 cis­ 3­ Hexenol .. I CaHtsO n­ Nonanal 13 3 X X 16 CloHzoOz Ethyl octanate ­ I CTHIOO 17 Benzaldehyde I x . X CIOHZOO Decunal 3 19 I X X CIIHZZOZ Ethylpelargonate . . 22 I CiH803 fihyI­ 2­ furoare X 23 1 GHnO Aremphenone . . 24 1 CeH1oOz Ethyl Cenzoate 1 . 25 C1zH~ 402 Ethyl caprate I ­x 26 CsH 1 4 0 4 Diethyl sureinate 1 X CI nHs Napthalene 29 I 32 T~ ethyldihydronaphthafene CloH1202 EtIplpheny7aretate. X 34 I ­ .x ClnH~ rOz IPhene~ hyl acefure X . 35 1 ­ x CnHsNOz Aicrhyl attthranilate 36 4 C14HZeO: Ethyl lawme 37 1 CsHlnO .'b~ hcny&? thanol . . 1 X X X X 1 . .)8 CloH1sO Linalool x . X x X X X X X x X X 28 . C13H16 X X The componenls found for the first time in wine by headspace tecknique. are given in italia. The components found for the fifst time in wine. are in bold. I. &<& li a d R. \'& ni Sithout splitting. Thc maintained at 26O. c n at 70 eV and 50 FA, md mass spectra with ' the chromatographic :w and aged wine can entitication ?x sd' x X X x X X X X X X X .x ­x X ' X X x X X x ' X X ,x .. . ' , x x msoc Rdesco 1973 I i ­2 ! i i Rirbesco 1966 "J Figure 2. G. c. traces of. 1973 and 1966 wines headspaces. Among &e constituents identified I ,I .6­ trimethyl­ l ,2­ dihydronaphthalene (dehydroionene) and 2­( ethoxymethyl) furan, were found for the first time in wine aroma. 1,1,6­ TrimethyI­ l, 2­ dihydro­ naphthalene had been previously described in strawberry, l2 peach 13 and tobacco leaves, 14 and in . rum, 15 passion fruit, I6 and peach fruit. '; Since we were unabie to detect it in Swiss Garnay and Pinot Noir red wines, 18 its presence in the aroma together with other leaf constituents such as cis­ and frans­ 3­ hexenols, could be explained by differences in some operations of wine making. The ethyl ether, 2­( ethoxymethyl) furan: already known in white bread ar0rna1~. 20. has a fruity, aromatic and slightly pungent smell. The confinement of this compound io aged wine suggests that ageing processes involving ethanol reactions occur not only by esterification of carboxylic acids, as other authors have observed6J1* 21.22 hut also by etherification of Maillard­ formed alcohols, such as 2­ furfuryl alcohol. Further work is in progress on the genesis of these compounds. i f 4. Conclusion i Headspace analysis, in which one measures only the volatile constituents present in the atmosphere of the glass in their natural equilibrium conditions, could become the technique of choice for 1 following the evolution of wine "bouquet" and thus supplement the information on the total aroma obtained by standard solven't extraction techniques. i Acknowledgements 1 We thank Professor G. Montedoro for useful discussions, and Dr G. Philippossian for the synthesis of ethyl furfuryl ether. . j References 1 1. 2. 3. 4. .5. 6. 7. 8. 9. 10. , 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. c; TAB C. USlFDA REGISTRATION OF METHYL. ANTHRANILATE AS A GENERALLY RECOGNIZED AS SAFE (GRAS) MATERIAL. TABLE OF CONTENTS 1. 21 CFR 1182.60 ­ Synthetic flavoring substances andadjuvants; 2. 21 CFR 184.1021 ­ Benzoic Acid Methyl anthranilate (methyl­ 2­ aminobenzoate) 8 182.40 21 CFR ChA (4­ 1­ 91 Edition) § 182.40 Natural extractives (solvent­ free) used in conjunction with spices, seasaninp, Natural extractives (solvent­ free) used in conlunction with spices. seasonings. and flavorings that are generaflyrecognized, as safe for their intended use, within the meaning of section 409 of the Act, are as follows: and flavorings. ­~ canmon name Botankal m of plant saum W t kemel (persic oil) PlUOUS MneniBC8 L Peach kernel (persic air), .........­........".­... ". f" penica %b. 81 % Peanut stearine .­ ............................... ..~."...­..~ Arachis hvpooa~ L Persic o i l (s e e apicot kwnel and peach kemdL". ~uince seed ........................................ ......"­ cvdonia OMOnpa Mil&. E42 F R 14640, Mar. 15.1977. as amended at 47 FR 47375. Oct. 26,19821 I182.50 Certain other spices, seasoninge. essential oils, oleoresins, and natural extracts. Certain other spices, seasonings, essential oils, oleoresins. and natural extract8 that are generally recognized 8s d e for their intended use. within the meaning of section 409 of the Act, are as follows: B 182.60 Synthetic flavoring substances Synthetic `flavoring substances and adjuvants that are .generally recog­ nized as safe for their intended use, within the meaning of section 409 of the Act, are as follows: Acetaldehyde (ethanal). Acetoin (acetyl methylcarbinol). Anethole (parapropenyl anhole). Benzaldehyde (benzoic aldehyde). N­ Butyric acid (butanoic acidl. d­ or I­ Carvone tcarvol). Cinnamaldehyde (cinnsmtc aldehyde). Citral (2.6­ dimethyloctadien­ 2.6­ aZ­ 8. gem Decanal (N­ decylaldehyde, capraldehyde. nial. nerd). c­ 10). capric aldehyde, caprinaidehyde. aldehyde and adjuvants. Ethyl acetate. Ethyl butyrate. 3­ Methyl­ 3­ phenyl glycfdic acid ethyl ester (ethyl­ methyl­ Dhenul­ fclucidate. so­ called strawberry aldkhyde. 6 1 6 aldehyde). Ethyl vanillin. Geraniol (3.7­ dfrnethyl­ 2,6 and 3,6­ octadien­ 1­ 02). Geranyl acetate (geraniol acetate).. Limonene (d­, I­, and dl­). Linalool (linalol, 3.7­ dimethyl­ 1.6­ octadien­ 3­ 02). Linalyl acetate (bergamol).. Methyl anthranilate tmethyl­ 2­ aminoben­ Piperonal (3.4­ methylenedioxy­ be& d* Vanfwn. E42 FR 14640. Mar. 15. 1977, as amended at 43 FR 47724. Oct. 17.1978: 44 FR 3963. Jan. 51907, Nov. 15. 1983: 54 FR 7402. Feb. 21, 19, 1979: 44 F'R 20656. Apr. 6. 1979; 48 F'R 19891 ff 182.70. Substances migrating from, cotton and cotton fabrics' used in dry food packaging. Substances migrating to foodfrom cotton and cotton fabrics used in drY food packaging that are generally r y ognized as safe for their intended use, ­within the meaning of section 409 of the Act. are as follows: Beef tallow. Carboxymethylcellulose. Coconut oil, refined. Cornstarch. Gelatin. Japan wax. Lard. Lard oil. Oleic acid. mate). .. hyde, heliotropin). 404 Food a Pearrut c Potato s sodium sodium I sodium I sodium 1 SOY­ Talc Tallow (1 T ~O W n Tapioca 8 Tetrssod me!& st zinc m a E42 FR 1 43 FR 1 May IS, FR 27801 Nov. 7. 1' FR 51909 52445, 5; May 7.1s f4 18290 . fram s u m in food paper a recogniz use, wit1 of the A Alum <do 12SAlum moniun Aluminlu Aluminm Cellulose CaSeil3. Diatomac cornstarc Ethyl cell Ethyl van Glycerin. oleic add Potsssiun Silicon d i t sodiuni al sodium cl Sodium hj Sodium h: sodium PI Sodium si sodium sc Sodium tr SorbitoL Soy protei Starch ac Starch. pr starch. ut Talc. Zinc hydn Vanillin Zinc sulfa E42 FR 141 0 184.1011 tc) The ingredient is used as a flavor­ ing agent as definedin H 170.3( 0)( 12) of this chapter: leavening agent as de­ fined in 8 170.3( 0)( 17) of this chapter: and pHcontrol agent as defined in 0 170.3( 0)( 23) of this chapter. (d) The ingredient is used in foods at levels not to exceed current good man­ ufacturing practice in accordance with 0 184. UbXl). Current good manufac­ turing practice results in maximum levels, as served, of 0.05 percent for baked goods as defined in g 170.3tnM1) of this chapter; 0.005 percent for non­ alcoholicbeverages as defined in 0 170.3( n)( 3) of this chapter; 5.0 per­ cent for condiments and relishes as de­ fined in § 170.3tn)( 8) of this chapter: 0.45 percent for dairy product analogs as defined in 0 170,3tn)( lO) of this chapter; 0.3 percent for fats and oil as defined in H 170.3tn1( 12) of this chap­ ter; 0.0004 percent for frozen dairy desserts as defined in f 170.3tn)( 20) of this chapter: 0.55 percent for gelatin and puddings as defined in 8 170.3tn)( 22) of this chapter; 0.1 per­ cent for gravies as defined in § 170.3tn)( 24) of this chapter; 0.3 per­ cent for meat products as defined in P 170.3tn)( 29) of this chapter: 1.3 per­ cent for snackfoods as defined in § 170.3( n)( 37) of this chapter; and 0.02 percent or less for all other food cate­ gories. (e) Prior sanctions for adipicacid different­ from the uses established in .this section do not exist or have been waived. E47 FR 27810. June 25.19821 I 184,1011 Alginicacid. (a) Alginic acid is a colloidal, hydro­ philicpolysaccharide obtained from certain brown algae by alkaline extrac­ tion. (b) The ingredient meets the specifi­ cations of the Food Chemicals Codex,, 3d Ed. (1981). p. 13. which is incorpo­ rated by reference. Copies are avail­ able from the National. Academy Press, 2101 Constitution ­Ave. NW., Washington, DC20418, oravailable ' for inspection at the Office of the Fed­ . eral Register, 1100 L St. NW., Wash­. ington. DC 20408. ­k ) In accordance with 8 184.1( b)( 2), the ingredient is used in food only within the followingspecific limita. ' tions: soup and mlxea ?P 5 170.3( n) (40) Of this chapter. (dl Prior sanctions for this ingredi­ ent different from, the use established in this section do not existor have been waived. C47 F'R 41375, Oct. 26.19821 I 184.1021 Benzoicacid. zenecarboxylicacidtC7He0,). occur­ ring in nature in free and combined forms. Among the foods in which ben­ zoic acid occurs naturally are cranber­ ries, prunes, plums, cinnamon, ripe doves, and most berries. Benzoic acid is manufactured by treating molten phthalic anhydride with steam in the presence of a zinc oxidecatalyst. by : the hydrolysis of benzotrichloride, or by the oxidation of toluene with nitric acid or sodium bichromate or with air in the presence of a transition met@ salt catalyst. (b) The ingredient meets the specifi­ cations of the "Food Chemicals Codex." 3dEd. ( 19811, p. 35, which is incorporated by reference. Copies may be obtained from the National Acade­ my Press, 2101 Constitution. Ave. NW.. Washington. DC20418, or mayex­ amined at the Office of the Federal Register, 1­ 100 L St. ' NW.. Washington, tc) The ingredient is used as an anti­ microbial agent as defined in 170.3( 0)( 2) of this chapter, and as a flavoring agent and adjuvant as de­ fined in 0 170.3( 0)( 12) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufactur­ ing practice. Current usage results in a maximum level of 0.1 percent in food. tThe Food and Drug Administration (a) Benzoic acid is the chemical ben­ . DC 20408. 422 Food has cant1 woul (e) ent lishe that ter, 142 F 49 m § 184 CAS (a cal I ered fatt Pare fern tion in c (b cati Cod incc be c Wa ami Reg DC (C ing 0 1: (( acc not Pra ser go( Ch: fin 0.0 fin f 0 1 0 1 tin 5 1 pr' t h f i I O.( f iI fo er OUS pra ar ­91 Edition) cific limita­ his ingredi­ established st or have ?mica1 ben­ 3A occur­ combined .which ben­ re cranber­ .mon, ripe snzoic acid ng molten ?a m in the ltalyst, by :1loride. or with nitric 3r .".­;$ h air .. which is 'opies may .la1 Acade­ Ave. NW., .lay be ex­ le' Federal uslhington, a, an anti­ fined in .d n d a s a nt as de­ 5 qhapter. in1 food at .Wfactur­ 3 S ~l t s in a nibtration ­t., b food. Food end Qrug Administration, HHS has not determined whether signifi­ cantly different conditions of use would be GRAS). (e) Prior sanctions for this ingredi­ ent different from those uses estab­ lished in this section, or different from that set forth in part 181 of this chap­ ter, do not exist or have been waived. 142 mZ 14653, Mar. 15. 1977, as amended at 49 FR 5610. Feb. 14.19841 I181.1025 Caprylic acid. (a) Caprylic acid CCH,( CH,), COOR, CASReg. No. 124­ 07­ 21 is the chemi­ cal hame for octanoic acid. It is consid­ ered to be a short or medium chain fatty acid. It occurs normally in vari­ ous foods and is commercially pre­ pared by oxidation of n­ octanol or by fermentation and fractional distilla­ tion of the volatile fatty acids present in coconut oil. (b) The ingredient meets the specifi­ cations of the "Food Chemicals Codex," 3d Ed. (1981). P. 207. which is incorporated by reference. Copies may be obtained from the National Acade­ my Press, 2101 Constitution Ave. NW.. Washington, DC 20418, or may be ex­ amined at the Office of the Federal Register, 1100 L St. NW., Wasfiington, DC 20408. <e) The ingredient is used as a flavor­ ing agent and adjuvant as defined in 8 170.3( 03( 123 of thischapter. (dl The ingredient is used in foods in accordance with § 184­ 1( b)( l), at levels not to exceedgood manufacturing practice. Current good manufacturing practices result in maximum levels, as served, of: 0.013 .Percent for baked goods as defined in 0 170.3( n)( l) of this chapter; 0.04 percent for cheeses as de­ fined in § 170.3tn)( 5) of this chapter; 0.005 percent for fats and oils as de­ fined in H 170.3( 11)( 12) of this chapter, for frozen dairy desserts as defined in 9 170.3tnX20) of this chapter, for gela­ tins and puddings as defied in H 170.3( n)( 22) of this chapter. for meat products BS defined in 9 170.3tn)( 29) of this chapter, and for soft candy as de­ fined in P 170.3tnX38) of this chapter; 0.016 percent for snack foods as de­ fined in 5 170.3( n)( 37) of this chapter; and 0.001 percent or less for all other (e) Prior sanctions for this ingredi­ ent different from the uses established ' food categories. in this sewon a0 noz exist or nave been waived. [43 FR 19843. May 9,1978, as arnt FR 5611, Feb. 14.19841 I 184.1027 Mixed carbohydrase w e enzyme product. fa) hlixed carbohydrase and protease enzyme product is an enzyme tion that. includes carbohydrase and the culture filtrate resulting xrom a pure culture fermentation c * ~ ~~ ~ 1 pathogenic strain of B. lichen (b) The ingredient meets the specifi­ cations of the Food Chemici 3d Ed. (1981). p. 107. which is incorpo­ . rated by reference. Copies are avail­ able from the National Academy­ ­ Press, 2101 Constitution A"­ "" I Washington, DC 20418, or available eral Register, 1100 L St. NV ington. DC 20408. the ingredient is used in fooc' 1 limitation other than currt manufacturing practice. The tion of this ingredient as generally rec­ ognized as safe as a direct human food ingredient is based upon the following current good manufacturi" conditions of use: (1) The ingredient is used as an this chapter, to hydrolyze protelns or carbohydrates. (21 The ingredient is used in the, fol­ lowing foods at levels not to exceed current good manufacturing ­ ­­ ­ ~ alcoholic beverages, as defined in 0 170.3( n)( 2) of this chapter, candy. nutritive sweeteriers, and protein hy­ drolyzates. 148 F R 240, Jan. 4.19833 8 184.3061 Lactic acid. (a) Lactic acid (C3H603. CAS Reg. Nos.: DL mixture, 598­ 82­ 3; L­ isomer, 79­ 33­ 4; 0­ isomer, 10326­ 41­ 7). the chemical 2­ hydroxypropanoic acid. occurs naturally in several foods. It is produced commercia"" mentation of carbohydrates glucose. sucrose, or lactose, or by a protease activity. It is obtai: ­ J I for inspection at the Office of " 1 (c) In accordance wnn 3 18% 1( b)( i), ­­­­* '­ ­ I enzyme, as defined in § 170.­ I ­lL'­ ­­ ­~ e .. TABLE OF CONTEWS 1 . Fenaroli'sHandbook of FlavorIngredients, Second Edition, 2. Perfume Synthetics and Isolates Volume 2 I \ , ! t FENAROLI'S HANDBOOK FLAVOR INGREDIENTS Second Edition Volume 2 Edited, Translated, and Revised bY THOMAS E. FURIA d NICOU) BEUANCA QVtl47p­ 1 Palo Alto. Culifortzia Published by Adapted from the Italian language works of PROF. DR. GIOVANNI FENAROLI Director, Center for Srudies of Aromatic Substances University of Milano. Milano. Italy CRC PRESS. Inc. 18901 Cranwood Parkway Ckveland. OhioU128 .. . .. .. e" . ' , I' €46 Fenaroii'r Handbook of Flavor Ingredients Stmture Pbysical, 'chemial characteristicsJ APP= iUKC *= Y Moleculu weight Melting point Wii point Congealing point SpeciBc gravity Refractive index Cresol mtmt Solubility Organokpiic char­ acteristics SyMwsis Natural OCCII~~ CLKC Regulatory status P c m ~l methyl ether pMethoxy toluene Methyl pcrcsol Methyl ptolyl ether Methyl 2­ aminoknzarre Methyl u­ aminoknzoate (?" CH, . CH, Colorless liquid 122.17 0.96do. 970 st i5­/ 25'C2 1.5100­ 1.5130 at 20'C2 Not more than 0.5 0iz Fungent odor suggestive of ylang­ ylang By methylation of pcresol Reported found in the oils of ylang­ ylang cananga, and 0 t h ~~ ­ . Non­ alcoholic beverages 1.7 ppm Ice crram. ices etc. 2.7 pprn kked goods 7.6 Ppm jehtins and puddings 0. W. o ppm hdiments 2.0 ppm ­A 121.1164; FEMA No. 2681 h M i Y 4.8 pprn iYrUPS 8.0 pprn REFERENCES , For References 1­ 5, Jee end. of Part 111. 6. Mattick et d.. 1. Agric. fmd Chrm.. 4. 331. 1963. 7. Roger, Food Technof.. 6.309. 1961. v t Colorless to pale­ yellow Itquid uith bluish 98O, mln' 151.17 24­ 25 C i32'Cat I? mm Hg . 23.8. C (24 C ) t. 161­ 1.169 at IS .25 C: ' 1.16.$ 0 at 25 6 1.5820­ 1.5810 at 20 C: ' 1.5802 at I5 C fluorescence Characteristic orange­ flower odor. and dlghtly brtter. pungent taste By heating anthranilic acid and meth> i and subsequent distiliatlon alcohd in the preKnce of sulfzric s:: d Reported found inxw­ al essential oil*: neroli. orange. bergamot. lemon. man­ darin. jasmine. tuberose, gardenla. champaca. ylang­ ylang. and o t h m : also in the juice and oil of I :1t5 iabrusrrr*~ ' Non­ alcoholic beverages 16 ppm Alcoholic beverapcs lce cream. ices. etc. 0.20 ppm Candy II ppm Baked goods 56 pprn Selatins and puddings 13 ppm IO ppm Cheuinggum 2.200 ppm FDA GRAS: FEMA No. 2682 . * I ' . .. a I and IsoZates BY PAUL 2. BEDOUK14W, PH. D. Conlpagnic Parenlo, Inc. D. VAN XOSTRAND ­ COMPANY, INC. *NEW VORK , p NEW TORK I). Van Nodrand Company, Inc., 250 Fourth Avenut, New Yort 3 TORONTO D. Van Sostrand Company (Canada), Ltd., a8 Bloor Street, Toronto .3f~ crnillan'& Company, Ltd., St. Martin's Street, London, W. C. 2 LOXWN ANTHRANILATES Methyl Anthranilate N­ Methyl Methyl Anthranilate, CfJHfrO2N 3101. Weight 151.08 Dimethyl Anthranilate C* II,, O~ X Siol. Weight 165.09 Although Fritzsche's discovery of anthranilic acid dates hack to 1841, the importance of its esters, especially the methyl ester, was not r e a l h a until 1899 dien Walbaum noted its occurrence in neroli oil. Methyl anthra­ nilate has since been found iu .a number of other essential oils and bas attained !onsiderableimportance as a perfumery material. Although it possesses a powerful and pleasant odor, the use of anthraniiic acid and its esters in perfumes is limited, however, because the amino group reacts most readily with various aldehydes, giving highly colored Schiff bases which are undesirable. Large amounts of methyl, anthranilate­ or other esters a n n o t therefore ' b e used in most cases, as for example in cosmetics and soaps where discoloration is a serious problem. Derivatives of anthranilates where the amino group ia bound­ say, with an acetyl group­ are usetes for perfumery purposes, since they are either extremely weak in odor or odorless. Large quantities of methyl anthranilate are manufactured annually for the­ flavor industry, most popular grape sodas depending mainly upon ­methyl anthranilate for the characteristic grape flavor. Occurrence.­ XethyI anthranilate has been found in a nunlber of essential oils, being first rrported in neroli oil by Walbaum. 1 This oil is obtained from the flowers of the bitter orange tree (Citrus biguradiu R.). It has also been identified in the oil from jasmine .flowers cultivated in France. 2 Practically all jasmine oils from flowers cultivated in other countries contain SIWIII quantifies of methyl anthranilate. Other source include : f Mol. Weight 165.09 Oil of rcrcir Bowers (Robiniu psc* doocacia L.) 8 Oil of tuberoe (Polyunlhcr tutcrotu­ L.) ' oil of nalfbov; en (Chciranfhw cheiri L.)@ oil of gardenia dowen * Oil from the leaves of the bergamot tree' Orange oil ' 3fetlq­ l antbranilat; has also been found in grape juice.) X­ methyl methyl antbranilate is known to occur in mandarin mendah leaf oil, ll oil of Koenlfctia efhclia," oil of rue,!! and in the oil of hyacinthflowers (Byacinlhtcs oricnfulis L.)." Preparation of Anthranilic Acid.­ Anthranilic acid was discovered in the course of studies on indigo. In 1841, Fritzsche treated indigo with concentrated solution of potassium hydroxide at elevated temperatures and obtained a greenish­ yellow solution. This solution on acidibcation gave a dark brown precipitate which was later identified as chrysanilic wid. The latter decomposed on warming with mineral a&, and one of the products crystallized­ out. This product, which remairied unknown to the perfume industry for more than fifty years, was anthranilic acid. Nethyl anthranilate was prepared synthetically shortly after its dis­ covery in various essential oils. The literature on methods of preparing anthranilic acid is qnik volum­ inous and a fd discussion of the various rnethocb cannot be undertaken here. The acid has been prepared from various bewnt derivatives having an alkyl and nitro grouping in the ortho position. For example, it can be obtained by treating ortho­ nitro benzyl alcohol with sodium hFdroxide solution, 1' ortho­ nitro benzoic acid with zinc and hydrochloric acid? ' or by reducing orthonitro benzaldehgde with zinc dust and alkaliJ8 ­ An unusual q­ ntbesis of anthranilic acid consists of treating ortho­ nitro " 8 Elre, Ckm. 2rg. 34, 814 (1910). 4 El­, Bcr. 36, 1465­ (1903). 6 Kummcrt, Ckm. ttg. 35, 667 (1911). * Pmroor. Bod. d i m . form. 41, 489 (1902). 7 GuDii .t% Chcmut and mgki 60, 1995 (1m). 8 Pam. Chcmuf 0­ d Druggut 56, 462 and 2 2 (1MO). 0 Power, J . Am. Chtm. Sor. 13. 375 (1921). 10~ Tdbtom, J . pdt. a r m . I?]. 62, 136 (lOU0). n" anbot, Coappt. red. US, 580 (IS=). I* Goddig mud Roberta, J . C h m . SOC. 101, 316 (1915). 18 Shimme1 t Ce. Report, October (1901). 47. 14Hoejenbor and Coppenr, Rev. morquu parfum. rt (1931), 588. I C c l r r e , BUZZ roc. dim. Pranm 131, 33.1161 (190% 1? Belktain and Kublberg, AU 163, 138 (1872). I* Frr~ ndlcr. BUR me. d i m . Prance [SI, 31, 450 (1904). 1sFlit+ e, 1. p 0 L ­C . C b t ­2 3 , 67 (1841). ' 56 11 I nilic acid. One molecular quantity of the phthalimide is dissolved in three molecular quantities of aqueous alkali solution. To the cooled solution are added two molecular proportiolls of sodium hypochlorite with constant agitation. After several hours the oxidation 'is brought to completion by heating the mixture for half an hoar. The mixture is then acidified and tbt precipitated anthranilic acid subjected to purification. The yields obtained by this process are of the order of 'IO per cent,= of anthranilic acid by the reduction of ortho­ nitrobenzoic acid with sulfuric acid and iron o t copper metal. This process, however, does not seen1 ta haye fannd commercial application. ., More recently a patent has been obtainedm describing the production I ­ AXTRRc with alkali. The re common method Y V I . ­I 50 PERFUYERF sY1` STIIETICS A S D ISOLATES ' f The above procedures u l alcoholysis do not work well with tertiarr i slcohols and an interesting variation is emplopd ill the preparation of such esters as Iinalyl anthranilate {IX). In this case, linatyl formate is i sodium alcoholate of linalool. Thus, 1 mole of litlalyI formate (VIII), 1 1 mole of methyl anthranilate (IV), 0.05 mole of linalool, and 0.05 atom of sodium are heated for several boun, and the methyl' formate formed dlowd to distill O~ T.~ ' The followingreaction takes place. 1 reacted withmethyl anthranilate in the presence of a small amount of : i IX AU of the above­ mentioned derivatives were esters 02 the carboxyl group in anthtaniIic acid. The other active group, namely, the amino group of anthranilic acid, is equally capabie of undergoing reactions and giving interesting derivatives. . 8­ Methyl methyl anthranilate, which, (LS mentioned previously, wcum in se~ cral essential oih can be prepared by treating anthranilic acid (I) Congding Point 18% 1S. C. 1cc. I2. C. 1O. C. 60 PERFD'YERP SrNTBETICS AKD ISOLATES Chemical Properties.­ Bn~ hranilic acid reacts with simpler aldehydes in a definite manner. Thus, 1 mole of formaldehyde condenses with 2 moles of anthranilic acid." XI rY XI1 The amine group can be acetylated by treating the acid with acetic anhydride.=­ Although esters of anthranilic acid are stable to heat, anthranific acid itself decomposes to aniline and carbon dioxide on heating to 210' C. a It h interesting to note that in nature methyl anthranilate and indole are very often found together. Skatole (XIII) can be oxidized to acetyl anthranilic acid (SIV) uith potassium permanganate. N XI11 I I XIV .... 7 .: ao H e 6 and Fieuelmnnn, ARK 324, 119 (1902). 81 Ticdke, Bcr. 42, 611 (1909). 32Kaufmann, Bcr. 42, 3455 (1909). as Fritrrhe, Inn. 39, 86 (1511). as Qtr. Pat. 137,008, Norembcr 29, 190?, ;I 8 , Jackson, Ber. .14,885 (1881). A3Th / ........ ............. .. . ... ...... .. ... ..... .. .......... ......... ­, ...". .. .I ...~ Ifany 6UCh interrelationships haw been studied in detail since they rre of considerable importance­ in the spthesis of indigo and other dpstuf! r I 1.68 8 1.76 6 5.11 S ~ ­ The anthranilates are shipped in glass or aluminum containers. Tb­ lined containers are also used occssionally. They should be stored away from light; otherwise they undergo considerable disco~ oratioa ... ..................... __ .:,. .......... .. ....... . . ­j . ­ ... I................... I __ ... ...... ....... ......... , :> .,_.­..._ ~ ...... :.,: ......... .. .. p t y TAB E U. S. DEPARTMENT OF COMMERCE SCIENTIFIC \ 'k­ b' LITERATURE REVIEW OF ANTHRANILATES IN FLA? 7QR USAGE. VOL. I. fntrouduction and Summary Tables of Data, Bibliography. TABLE OF CONTENTS 1. 2. 3. 4. 5 . .. 6 . 7. 8. Toxicity to mouse, rat and Guinea pig. Chemical identity and physical properties Pharmacological and toxicological ef€ ects Natural occurrance Flavor and Extract Manaufacturers' Association (FEMA) and Addendum to Table IV­ 2 Bibliography Data guide. National Acadamy of Science (NAS) use levels. Scientific Literature Review of Anthranilates in Flavor Usage. Volume 1. .Introduction and Summary Tables of Data, Bibliography flavor and Exltod Manufactunrs' Association of .the Unitd States, Washington, DC fwd and Drug Administration, Washington, DC Nor 10 291112 SCIEMIFIC LITERATURE REVIEW ' OF AMMRANILATES IN FUVOR USAGE . .. .. SCIWlFIC LITERATURE REVIM OF ANlliRANIUTES IN FLAVOR =AGE BIBLIOGRAPHY bY SCIEhTIFIC LITERATURE REVIEW OF A8TIiRAs 1 LATES IN FLAVOR US ACE PIgC 1­ 3 4­ 8 sEc? IcN 1 . A. S. .. ., , 9­ 12 13­ 17 SECTION 11. SUBSTANCES REVIEWED Ncrrsriul Designation urd Chemic81 Identity . (Table 11­ 1) Alphabetical Cnus­ Reference List of Nbms and Synonym­ (T r b l ~. 11­ 2) Physical Proporties l. fable 11­ 5) A. E. C. 18­ 24 . SECTICH 111. A. SECTIW IV. A. 1. 39­ 42 4 5­ 73 SECffON V. 74­ 79 SECTIQJ VI. 60­ 96 V O W 11. COPIES OP .WICLES CInD IN SIwI( ART SECTION SEcTIOH I .A. This revieu is a prssentatioa of det? p e r t i n e n t t o the safety evalua­ ti= of mthraailrtss wed as flavor ingredients, fhe 14 substances uere selected for renew Y 8 gmup because of their close chemical relationships on tho asrumption that the) would f o l l w s i d l u metabolic 3rthwryr, and havo sim5la. r physiological effects in tho mamnialian organism. The list of sdrtmces rovicrwtd urs compilerr fma sevtrlj sources. I t includes flavoring caapo\ pl& tistad by tho Food urd k g Admiairtratiacr (FM) in ,Ticlo 2: of the Cod. or' Fed0181 Regulations ,. md rdrtaaces clurifird u Gonorrlly Recognirsd u Safe (GRS) by the Expert Pmal of the Flavcr 8ad Extract Mmufacturers' k s o d a t i o n (­ 1 urd recognAred by FpA;. md ury additional flavor rdsturces roportod by. rtsponden: r t o a aatiaul s w r y conducted by RUA Bnd the Natian. 1 Acat3r. r of Sciences/ riational Resuucb Council !NAT; lNNRC) in 1970­ 1971. C; uid. linor for the typos and ammt o f data t o be gatherod yet. developed . . in consultrtioa utth the EqorC Puul o f RClA (4 5 1, a d in ucordutc6uitb tho ctftorir pub: irhed by tho bod Proteetian Colrittw o f .the Natiaul A u d y of Sciences/ Nationrl Res­ Cormcil (WRVRC) (% 1. Ih8 bulk of the infomtioa on biologic81 properties YU &t8ined froll a soarch of the sciearific'literrturi frolr 3930 thm­ 1977, hy articles, revim md texts wet. well Lnavn urd had been utilized in oulier evalwtionr. Using t h i chemical aIyr (u wtll u the c­ n ae1# .md ryno­ nyrs of gach r\ rbrtanw) as key wor&, ca independent orgmixatisn urrid out t h i s search by locating a l l refe~ encer t o litersturn pertaining t o phyriologiui, yhWCOiOgiC8ls toxicologfal, metabolic or o t h t r b i o l o l i u l . fniorvtion or. &use substmces. This litemture s w d ) oxtended back t o 1920 for'the aeuch p u r a +t e r r t o s i c i t y and metrboliu. hppmximteLv 40 nformci8 uom 10cated in this reuth, but only thwe a r t i c l e s conttidq drtr relevant t o safety o~ alurrtlon r o n selected for inclwioa in this =v i r . S w i u of a l l OC tho rrlovmt articles Y e n then w r i t t e n urd are presented in Section 111. A .corrpleto bibliogrtphy o f a l l references lwsted,. whuther or not the articles were usod, 1s also included (Section v), 1 Iho informtion included on the natural 0ccurrcn; e of :he reviared sd­ c: uIces i n food *PI provided thxwgh food i n b t l v sources, and includes I I W ~O U references t o the open l i t e m t u r e . This natura: occurrence infor­ s t i o n is pxcsanted i n table foi­ t in Section :V. A. Physical data we= a l s o obtainod ftor the industry as v e l 1 as v a t L o u coapendia. Ihesa data are pre­ santod in S r c t i k I I . 0. t. on the usage of thcso srrbrturce u flavor ingre­ d i e n t s uoro 0ttuxa. d fro8 tho a8tioul surveys o f wrgcs cmducted by both FEW and by N W N R C in 1970­; 1. Theso data aert coPqri1. d by the M I N X , a d revoml calculations, includirg ai: e s t h t e d possible daily intake value, are pr* rurted and d w c r i k d in dotril ia Soctioa 1V. B. Ihr uniqueness of the types m d amorat of data presented, u uoll u the f o n u t for iu p n s o a t r t i o n , i? i d i c t a t e d by the f a c t thst flrvorinp sub­ stances c o a r t i t u t o I spodal s d o r o u ~ a i chemical c a u t i t r u n t r of fwd which 1 this problem has been tpprlached by coruidering the substances i? r gxyups or classes of structurally related c ~~o u n d s ,' a s well as individwlly. nit approach is j u t t i t i e d becaucsr o f t h e i r r e l a t i v e l y simple che8ical nature and the fact that the great o r j o r i t y f i * r e r d i l y i n t o w e l l e r t d l i r h c d pathways of metabolis8 describd proviowly i n W ' s Scientific Litcraturo k v i u of Alipbtic P r i p r r y Alcohols, AlMydes, ki.& md Estozr t 14 1. For theso muons, uch of the r e i o n t i f i c 1 itar8turo' is 8 b O org8nixed by groups of s t n a c t u n l l y r t l r t e d coapounds. A l l o f tho above arterial can be fomd as indicated ia t h o Table of Catents md is arranged as follows. F i r s t , imedi8toly follawing this Intro­ &tion is 8 rupury of tho biologic81 properties and other irponrnt data fros tho oatirc, reVi." Slrctiorr 11 of t h i s roviw iacludos tho fallwing: Tablo 11­ 1 lists ouh subst. aco includod i n tho ropolct, statu i t s chemical i d m t i t y , u. d pro­ vides 8 SpMifiC ~~r i C 8 1 d~ si@ UtiOA for *&; Tab1811­ 2 Cmt8im .­ alpha­ betical cmrs­ mfenr; ce list of n­ r and sy" 3nyu for o r h coqomd; . . TJ1o 11­ 3 givor tho physical p t o p o r t i ~ o f tho substances unhr roviw. Section .I t ! contains tha dotailod biological data for each iadividurf compourd, p r r r o n t e d i n tdlw containing abstracts o f all the individurl paprs frcm which thae dat8 wore t8. k. n. h b l o 111 preseats i d b r u t i o a on ~u m c o l o g i c 8 l a d t o x i c o l o j f u l offrctr, md .st& o1ism of'the substaaces. Sctioa IV is devoted t o tho pFuaF. ce urd amounts of 08ch of the CM­ potads i n tho food supply. Table IV­ 1 i s drvotod t o natural occurrwtce urd frblo IV­ 2 p k v i b r infomtioa c o l f o c t ~d by R34A urd NASORC with respect t o ­ tho US8g. 10VOlS O f 0. d SubSmCO. Section V is caaplotr biblioarrphy of a l l articles and papers con­ ' s i b r e d 'for us0 i n this rwim,. including a r t i c t u aot deemed' refovaat u well u r r t i c l o r f r o m uhidr d8ta wen r c t w l l y takea. n o l a t t o r 8­ noted by ut asterisk precodily tho ontry. Tha find section of tho report, Section VI, pr0vid. r quick nfer~ nco to tho ammats and typu of d8tr pxormtrd for each s& st. nco in this r e v i a . : " . " SECTION I. B. Eleven simple esters o f o n t h r m i l i c u i d , 2 esters of H­ methylurthnnilic acid and othyl N­ cthylaathrurilic acid are reviewed here for thc*. r flavor use, All 14 substances are used a t lcru levels i n food a t average maximum we .levels . (50 pps, with the exception of UJO i n chewing gum (where wen high we !evels r e s u l t i n very lw ingestion) as follous: methyl m t h m n i h t c (No, 1) ­ 1583 ppm; ethyl anthrmilate (No. 2) ­ 116 ppm; .ethyl X­ methylanthranilate (No, 12) ­ 91. S ppm. The "possible rvozqe daily intakes'' for these throo rdstmces f r o m cherinp gum US. havo bwa calculated (seo Tablo IV­ 2) t o be 0.08, 0.91 and 0.005 q, respectively. nesa l o r usage levels are reflected in the lw mnua1 volumes for flavor US. which rage fmm 9 pounds for isobutyl N­ ncthylmthrurilate (No, 13) t o 2056 pounds for mthyl 'X­ nethylmthmilate (No. 12) and 75,300 paurds for wthyl anthranilrtr (No. 1). Iho calculated (sea intruduction to Table IV­ 2) per wit0 intakes aro 0.02 rg/& y or ~w o r for 811 except for 0.7 mg/& y for eethyi anthra­ nilrt.. ents of Iood ($ eo Tab10 IV­ I). Wrthyl m t h r u r i l a t r (No, 11 occuA in a d e r of f r u i t s : reported 1ovels tcing 17A ppa i n ­grape juico and 33 p p i n Concord grapes. Theso levo18 r n coqu8blo. to tho$@ resulting f t a flavor use. Ethyl rnthr8nilrto (NO. 2) i s also 8 component of grrprs. &thy1 N­ 8athyl. nthrdlate (No. 12) has boen roportd t o c o a s t i t u t o 0.7s) of bergamot o i l urd O .X \ of bitter oranzr oil. The th. rro largest voluw substaacer covered hen are 811 natural constitu­ iaTABOLISM k h v boon discussed befon [F. E. M. A. 1974. Ref. No, 141, tho 14 esters dcid O? N­ 8ikyl i n t h m i l i c studies on methyl anthrrnilato be hydrolyze4 t o an alcohol and .tither anthranilic acid. This sssmption is supported by in Vik. 0 (No. i) vhich, *hilo only slowly hydrolyzing i n 4 . a r t i f i c i a l g a s t r i c or pancreatic juice, is readily hydralyted i n r a t liver homogenate (50% i n 27 ainutes) and rapidly hydro1y: ed i n r a t small intestinc mucosa (SO\ in 2 .5 minutes) itongland, e t a l . 1977. Ref. ­So. 34 1. F'ethyl anthrani. late has also be en^ show t o be coqlercly hydrolyzed (, 99% in 2 hours) i n p i g , liver homogenate but is more r e s i s t a n t t o hydrolysis i n pig jejunum homogenate and completely unhydro1y: ed by pancreatic solution [CnmCschober. 1977. Hef. !a. 23). I n a d d i t i o n , lpcthyl K­ sethylmthranilate (Yo, 12) has been shown t o be hydrolyzed on oral adair. ia. tration to a hwur and a r a t [F. D. R. L. ulpubl. Wep. 1963. Ref. No. 18 J. A small amount of N­ Canethylatian occurs i n both c a e s . In an i n :u i t m StUdyD methyl S­ rwhylanthrrnilatt uas resistant to hydrolysis by p a n c r e a t i n o r p i g jejuI. um homqenatc but's993 hydxlyted i n 2 . , hourr by p i g l i v e r homogenate [Cnmdschober. 1977. Ref. So. 23 1. I t has also been s h w n t h a t methyl &­ 8cthylanthr&, il8te w a s ra2121Y rbso* d f r o m the small intestin8 of guine8 pigs, corpletely hydrolyzed a t 10u cimcmtntionr 8nd par­ t i q l l y hydrolyzed at higher cor., entrationr [Pelting, e t a1. Unpubl, Rep. ' !? ef,. so. 46 1. Prompt ditappearsrce f r o m the blood of .these guinea Figs indicated rapid Met8bolfS8. In supypxy, it appears t h a t t h e a n t h m i l a t e s are not hydrolyzed t o any a p p r e c i a b l e e l t e n t i n the StOmaChD but eXtenSiYe if not COBplete hydrolysis takes place o n a b s o r p t i o n t h r o u g h t h e i n t e s t i n a l u r l l s a t tht concentrations at which these substances aro used. Any remaining uahydmlyrd u t e i t a l can be hydrolysed by t h e liver. Excretion of anthranilic acid occurs primarily as o­ minahippuric 8cid and t o 8 lesser extent u anthmnilic reid glucuronide i n u. n [Brown. and Price. 1956. Ref. 80. 5 1, rabbits and. rats (Oarrcoanct­ tiarJing, e t 81. 1933. R e f . 80. 8 1. nJXICIl7 ­ !n l i @t of the above, it is obvious that 8 discussion of the toxicity of the 8 n t h r u r f h t e esters m u s t also i n c l u d e o n t h r 8 n i l i c a c i d d a t r , k r t h r 8 n i l i c r c i d is a nom1 Betrbolite i n man and is c x c r e t d i n t h a urine u 0­ 88inohip­ p u r i c acid (27 u# les/& y) and && ranitic acid alucutonid+ (6 vwXes/ day). Ihir is equiV8h1t t o tot81 rvetrge d 8 i l y excretion of &art f a# urthturilic a c i d p e r day [Ria. e t 81. 19%. bf. NO. 47 1. . hlr liritcd d8t8 a r e 8 v t i l .b l e on t h e toxicity of a n t h r a n i l i c a c i d ; however, the Or81 tbso of 4S49­ mglkg i n r a t s 1R. T. E. C. S: 1977.­ Ref. SO. 48 ] indicates low ,toxicity. It ha been reported 5 .. [Et­ and Strombeck. 1949. Ref. Xo. I?] that O.?\ in the diet of rats pro­ duces blodd.. r papilloma^ on long feeding. The oral iDjO values for the esters are also quite h i f i for t h i s class o f compounds, vllues ranging fnPl 2250 m&/ kg for methyl S­ methvlanthrsn: 'atc (SO. 1:) 13 guinea pigs t o >SG30 mdl'kp in rats for several o f the &t e s (see Table A­:). The two anthranilates uith highest eaposurc have botl; h e n studied more extensively. Methyl anthranilate (ertinroted as ?xplained in. the Introduction t o Table I V ­2 t o have a l e r qitct daily intake o f 0.31 8g/ kg for a t4 kg person) h* s been added t o t h e d i e t of r a t s at levels ;rf ?OOO. and 10,000 ppm trpproximtely equivalent t o an averape.& rfly intake of SO and 500 mg/ kg for an adult rat). f o r . 13 ueeks u i t h no Ldverst effects .( Haoan, e t 81. 1967. Ref.­ So. 27 j. 'kthyl X­ methylanthranilrtcr (No. 12) (estimated per qitc: daily intake of .C. OOO, t ag/ kg f o r a 60 kg'pcrson) added t o the d i e t of rats a t levels o f 300, 1230 and 3604 ppm (approximately 1s. LO and 120 ag/ kg/& y for 8n a d u l t r a t ) for 90 days, [Cauirt, e t 81. 1970. Ref. No. 23 f resulted i n 8 s l i g h t b u t s i g n i f i c a n t leukocytopenia and anemia a t t;. e 2 higher levels urd i n c r r u c d kidnc; ' w i g h t s i n tLe u l e s . No effects were seen at 300 ?pm. A drily intake of 19.9 q /k g (males) and 22.2 &kg (femles) by .rats for 90 days caused no 8dvem. e effects [Oscr, e t a l . 1965. Ref. So. 441. * Both methyl anthranilate (No. I ) urd einnuyl anthrrailate­( No, IO) in tricapxylin solution uem infoetad intrrperitonerlly 3 tines per week for I weeks a t the saxfur tolemted des. (WD) 8nd a t 0.2 tire the WfD in me mice uhich were maintsined for 15 rdditiorvl uetks betom. sacrifice and autopsy, Methyl a n t h n n i h t e w u injected i n repante doses of 0,09 d k g (0.2 m) a d 0.47 g/ bg (WTD) for 8 ­total doso of e i b r 2.25 or 11.2 g/ kg t o 20 f c u l e i a t s ' . each. A t t h e end of t h e 24 ueek test period (I week administration and 16 ueek observation) 3 of tho 18 survivors (ln) at' tho 1­ dose md S of the 19 sw\* ivon (26%) a t t h e m3 had developed lung tumors. C i n n q l a n t h r a n i l a t e MU injms­ d i n separate doses of 0.1 g/ kg (0.2 MTD) and 0.5 g/ kg (MD) for (L total dose of . e i t h e r 2.4 or 12.0 o/ kg t o IS male urd IS ftmale tats each. In t h i s case, a l l male rats 8nd IS f e u l o r8ts survived a t either dose. Sev? males (47E3 and 6 f e u l e s (468) a t tho low dose urd 14 v l c s ~~(Y 3 t ) and 7 f d e s (S4%] a t the'wTD developed lung ttrwr,. O f the 80 m l a urd 8C femslc controls injected similarly with tricaprylin, 77 8810s and t? females survived­ the test petioa. Of these z8t of tha males md 20\ .of the fe= lm developed lung tmm [Stoner, et 1973. Ref. No. 531. .c ...­ ,> 6 .. ..­ PI: ,"" . . . " e..­­ ." . ~ L l k 1. ,/ ., 1 , With. tha exbcpticns of isobutyl S­ methy1anthr: milatc (So. 13! and ethyl .N­ e: hylanthranilat~ (No. 14). which have never bees submitted to the Pane!, 311 o f the anthranilates discussed here nave been reviewed by t h e Exper, oanel of F. E. N. A. and found to be Generally Recoyrlired as Safe. (CRAS) under the condi­ tions o f intended use as flavor ingredients (F. E. M. A. 1965­ 1978. Ref. No, 15 1 . lhis determination w a s based on a review of a l l available. data as well as the rruonable analogies which the Panel juciged could be drawn. .# .. .. c! ': . se+^ so " S O Substance Spec ios Rout e ­ ­ L Werhyl anthrazilatc hb us e Xntrapeti toneal Rat Intraperitoneal ). bcs e Ora 1 kat (fasted) Oral Guinea pig Oral (fasted) ­ 17 30 1 7 30 30 Oral Oral 2 Ethyl anthrmilate Mouse Rat 17 42 4 Sutyl anthranilate Rat Oral 38 Oral ­ 4 1 I! . .. '..?. ... <.. .. Phenethyl anthranilate Rat Oral 43 Oral >S g/ kg 39 10 Cinnamyl anthranilate Rat 12 Methyl N­ mtthyl­ Rat (fasted) anthranilate ,. ,Rat Or81 Oral 23 2.2s­ 3.7 ml/ kg 3 .3 g/ kg 40 8 SECTIN 11. A. NUMERICAL DESIGNATION AND CHEMICAL IDENTITY TAEE 11­ 1 This table lists the prirpary names, chemical structures, molecular formulae and molecular weights of the substances included i n this review. These Corupoun~ 8­ listed by chmical stxucture as explained bclw, and am assigned I numberby which they a b referred thmughout th8 review. In order t o mom easily sake comparisons between metabolically nlated substances, the compounds are organired­ md n d e r o d according t o chemical structure pro­ gressing f r o m r t q l e s t t o . more complex. . A cross­ rsference of the restances and t h e i r s p o n p s is listed alphabetically ­in Table 11­ 2. Additional inclusions in Table 11­ 1 are: a) 'the n h e r assigned t o t h e substance by the Flavor and Extract Manufactu~ e~ s~ cIJsoci8tion (€ Em) in its prtblicatioas I f ] listing substances judged by the Expert Psnel of FEMA t o be generally recognized. u safe conditions 'of intanded use; b) the section o f 2 1 Cod8 o f Federal R e p l s t i o n r i n which tho r r ~s t a n c c l have been l i s t e d by' the Food and Drhg Mn$ strrtion '( FDA) ; c) the QIdca1 Abstracts registry number. I hl rr) bn bn N b c. .. L. l rr) m L. l 0 r 4 CJ 0 Y L1 " e4 0 11 c; m N .. e 5 .4 =m L. l m u Y r( e a Y c .a c. c x w Y 10 N .. .: L m m hl­ c4 .II R 0 2 Q v s: Fi Q 1 I­ wl (Y Q hl N 2 Q wl n" yr LI *! ' 4 u n" h =­ i c ­. u­ u" c I CI e Y d e Y 8 C L. 4 t s 5 0 *, d a * a a " .d 4 & CI Y rl 3 x ­3 L 0 d LI 2 x Q i a 9 Q Y, cy t­ I I I I I 2 ­m 9 L. .I n N m ­ N rn N 9 8­ N 0 n" 2 *a U U ?­ h 8" In =e4 U" r. ­0 Y L.. r. r. SECTION 11. b". ALPHABkTIUL CROSS­ REFERENE LIST OF SAME5 AND SySoNy). Ls TAB& 11­ 2 Thrr tablo .lists a l p h i b e t i d l y the principal names (i n ' c a p i t a l e t t e a ) a d synonyms [in louer case lotters) of the substances i n t h i s roviw. A l l synonyms am l i s t e d a f t e r o a A principal name u uoll. Iho ndcrs refor to tho rtnrctunl 1is. tiag i a T d l o 11­ 1 and indiuto tho ordering of tho tub­ ttmccu i a a11 othor tdlos. mi3 cmrr­ nteGacr list inc1dws tho30 synonyms most cauDnly found in tho literatwo md synonym, including soma trado names, frequently wed in tho flavor indwtry. In a11 c u .3 thr. rtder is rearred t o the cqitalired nasa u h i d is the n l w used throug. ho* t h i s review. No ­ 3 4 LO i 6 TABLE 11­ 2 AX nt tu.\ I LATE s Substvrse Si; ron \IS . ~l l y l 2­ rpinobentoate [ALLYL &W I L I \T E ­­n o . 31 A l l y l o­ iuninobntoate [A l l Y L "HRNIUTE­­ no. 31 ALLY t A S l I i i i X I UTE A I l y l o.­ uninobcururrr Allyl 2­ aminobcnrootc 2­ Propenyl ?­; lrPinobentoatt :­ Propenyl anthranilate Vinyl carbinyl anthruri: rta 6­ Amino methyl benzoate [WTHYL A!! WIUTE­­ no. 11 Butyl o­ uinobsnzocrte [BLIIYL ~1 L A l E ­­n o . 41 iw'­ htyl o­ aminobenroato [ISOSUlYL MTHUNiUTE­­ no. 5; Butyl 2­ rninobcnzonte [BUIYL MMWILATE­­ no. 41 .. BUTYL AKMRANIUTE Rttgl 2­ aminobcntoate Wltyl o­. cuinolenrorte b ­k t y l &n t h ~i h t . 1 I S 8 V n L AMMRANIUTE­­ M). S] CiMIII) Il o­ adnoburroat. iC1­ t NIH~ IU'TE­­ T~ O. 10) Cinnuyl 2­ ainobmzoate [CIMUNfL AMHRANIUTE­­ no. 10) c INNAMYL mRAN1 UTE C i n n u y l 2­& imbennrorto Cinnuyl o­ ainobcnroate 3­ Phenyl­ 2­ propenyl 2­ amino­ benzoate 3 ­P h ~y I ­t ­p m p ~t 8nthIWlil8te Cyclohexyl 2­ uinobentoato [CTC­ XYL AKIHIUNfUTE­­ m. 6j CYCLOHEXYL ANTHRANIUTE Cyclohexyt 2­ aminobcntorte .. 14 ­ i_ No " Subrtmc. Synonps Diethyl unthranihtc [E M L X­ LTHk'UhiIWIUTE­­ no. 141 Dimethyl anthranilate (WTHYL S­. WMU, XWlUTE­­ no. 121 . 3,7­ DiP~ thyl­ l, O­ octa~ ien­ 3­~ 1 2­ ullincbur: oate JUUAYL ApiTHaASlUTE­­ no. 7 ) $, 7­ Pi~ thy1­ 1,6­ octrCica­ J­~ l urthrrnilato ~L l W Y L AN'MWlUTE­­ no. t ] Ethyl o­ dnobenzoatr [ETHYL ANWXLATE­­ no. :! Ethyl 2­ dnobrnroate [ETHYL ~l U T ' E ­­n a . 2) Ethyl o­ adnobenzoate Ethyl 2­+ miaobmrolitr 5 Diothyl .nthturilrto Ethyl 2­ ethyluinobenroate Ethyl (2­ ethyluiaophcnyl) ­ 8ethuxnto Isobutyl 2­ uinobratorto (ISWJlYL A ~' M I U T E ­­n o . 5) Isobutyi 2­~ ethyluinobenrmtr [ ISO% VTrt N­ IIEMYUMHRANIUTE­­ ao. 131 Isobutyl 2­ methylmino­ 24ethylpmpyl 2­ wthyl­ kntoatr uinobaitmt~ tinalyl 2­ uinobenroato (UN& Yt ANTHRANIIATE­­ no. 71 7 1 it 11 Subs t mce Synonyms Linalyl c­ rminobcnroati [LIsMYL ANHMNItAI'F.­­ no. ?] LINALYf. &T1iRA! iILATE 3,~­ Diwrhyl­ 1,6­ octadicn­ 3.7­ Dimethyl­ i ,+ oitadien­ Linalyl 2­ aminobenzoate t i h ~&1 y . c­ aninobtnroatr 3­ yl 2­ ainoben: oate 3­ 71 rnth1urilate p­)( mthhr­ l­ m­ tyl 2­ uinobonroate ja­ TERPINYL &7lWh( IUTE­­ no. 81' p­ l4enth­ l­. rr­ l­ y1 ~thraniIgte [a­ TERPINYL N7HRANI'JTE­­ no. 81 2­ lbthtluriao wthyl bonroate [) 4EIliYL N­ lETHY~ RMIUTE­­ no. 12) m Y L AKIHRANIIAX o­ kino w t h y l bcnroa: e kbthyl o­ uinobenzoate Methyl 2­ uinobcnroate Dimethyl 8nthr. nilrto 2­ libthyluino rtthyl bontoate Matby1 2­ rwthyluinobentoate Wthyl o­ methyluinobenroate 2­ Naphthyl o­: rinobaroato [#­ NAPWHY1 ANMRANItAfE­­ no. 111 2­ Naphthyl 6­ uinobenzoato 2­ Nqhthyl mthrmilrto 2­ Naphthyl m t h r u r i l a t o f8­ U" HYI. uJTHRAxIUTE­­ no. 111 16 . No Substance ­ Synonyms 6­ Phencthyl o­~ minobcn: o; rte 2­ Pharylethyl mthrmilate 2­ Phenylethyl anthranilate (PHENETHTL Ah'l? lRAi. YIUTE­­ no. 01 3­ Phrnyl­ 2­ propenyl 2 ­u i n o t a t o o t e [CINNQIAHI'L ANMRMfUTE­­ rro. 101 8 a­ TERPINYL ANTHWIUTE ­ "_. ." . .­ " 1 SECTION I i .C. ­ .. I I I t should further be erqhuird that the data and descri? tion of sub­ stances contamed within this table r're those lasted in t h t referenced source and no o t t e q t Lss been made t o c l a r i f y these listings. ;or eurnplc. although sone substances ore listed as color! esr; i t should not be asslmpcd that com­ pounds not so designated are colord. As another exaprple, the d, ifference between sOlubl8 and 8isciblr w u not aluays clearly defined. Abbreviations Used in This Tablt alc I ethyl alcoho: s. 6 solubl. far insoluble rls slightly soluble l i q ­ liquid mr 6 melting point bp = boiling point rpg = specific gravity d = density doc 6 decowsu 19 I i I " " " ­ 1 i L I + I ­ .* ­ 9 4 1 " "­ b i a 3 .. a ­ f 2 . 3 f "' I .. I c) t 4 YI 22 .................. ........ ............. ...... ... .... ....... . . ................ ............. .. ........ : >.:..­ , .:. ....­, ..._ I_ ". i i z t P W .. 2.4 SECTION I If TAELE 111 lhis tablo contains inforvtion en tho biological yroperties and .stabolism of the substances included in this review. Tho bulk of this inferntion uu derived f r o m t r t i c l o s gt* rined ­Cram t coaprshcnsive survey of tho s d o n t i f i c l i t o r r t u m published betkcen 1.920 and 1977. This survey v u carriod out by an indepeaant orgurizstioa, bfomticsD lac. of RocLVillU, Cluy1­ d. .. hfomatics, Inc. u r d the chaical rima, c o m n naaos md syaonym of each substance as key uords t o locato reforcrncer t o tho publish& l i t e r a t u r e pertaining t o tho p h r r k o l o g i u l urd toxicological daQ on thoso substances. Summaries of a11 the portinont articles fro. this survey worn then written and are pnsentod i n this tal.. Othor data c o l l e c t e d f m a o u l i o r litera­ two md privrtr industry SOUIICOS 8ro also s­ izod .and includod h m i n . Iho tablo is orgaairod by subttaac. with the simplost c h u i c a l stnac­ t u o s procoding a0 .on C­ l.% D u in oqor roctions of this rovim. me nuberr rftor tho nmo of oach substurco uo the same f o i a11 the other tablos in the riviou. rithia or& substurco. gmup. tho entries ue.~ orpnized <.­. ! 25 .. bferencc KO. : 3.1 (Longland, W. C., e t 01. Toxicology. 1> 77) b t i I y 1 a n t h r a n i l a t e uas i n c u b a t e d w i t h a r t i f i c i a l g a s t r i c juice aJ a r t i ­ ficial Fancreat ic j u i c e at 37. for up to J hours. The time required for SO\ hydrolysis bas 5950 and 4150 minutes, respectively. i n SO$ hydrolysis in 27 and 2, s minutes, respectively, Incubation hith rat l i v e r homogenate and small i n t e s t i n e mucosa. resulted Reference No.: 25 (Gradschober, F. Toxicology. 1977) Methyl a n t h r a n i l a t e a t a cowentrarion of 100 or 250 u l /l w a s incubated i n 0.5M phosphate buffer (pH 7.5) at 37. w i t h e i t h e r p a n c r e a t i n , pig jejunum homogenate o r p i g l i v e r homogen8te for 2 hours. C U u d l y s i s r e v e r l d 0, 1s urd ,998 hydrolysis, respectively, of t h e ester. I , N m of Substance: !EB'zHyi AKl? iRANXLATf (1) Reference No.: 17 (F k Unpubl. Rep. 1977) Species: Nouse No. /Croup : 10 Duration: Acute Route : Intraperitoneal Vehicle: Sot Specified Control 0 Sot Specified Tho intraperitonoa: LD f o r methyl anthtanilato i n l i c e u u reported t o be 1.04 el/ kg (958 C. L. Oy­ 1.19 W k g ). Referonce No.: 30 (Janner, Z .M ., e t 81. Food Cosaet. loxicol. 1964) Spocies : .House No./ Group: Not Specified [kration: Acuto (14 day obremtiou) Route: otrl (intub8tion) \'ahicle: Nert Control: Not Sprcifid. Tho om1 LD (Litchfield­ Wtlcoxon) for methyl anthnnilato in mice w a s calculattd t o beSg90O 8 d k g (OS8 C. L. 3260­ 4680 &kg). Symptom of toxicity included depression and death uithin 4­ 18 hours. i i . c * k& J \ Roforenco No. :­ 53 (Stoner, C. D., e t a1. Cancer Res. 1075) Species: )louse (W e ) Rout. : Xntrrp. riton& l No./ Crwp: 20 (F) Vehicle: Trieapxylin Duration: 8 w e +L t (24 week obsonation) Control : Tricqrylin alone Mica wore injected inttrperiteneally uith 24 d a m , cithar 0.09 g/ kg ­or 0.47 g/ kg.; of methyl a n t h r 8 n i l i t o i n t r i c r p x y l i n 3 tims per week for 8 weeks f o r 8 t o t a l dose of eithor 2.23 or 11.2 fig. A t the. higher dose, 19/ 20 feaalos sunivad the treatment, while a t the lower dam .the survivors wero 18/ 20. A t the ond of the 24 week test period, 3 (268) had develoyd luly tumrs a t tho high dose and 5 (In) had a t t h e lower dolo. Y i t h tricapryfin alone them utre 77/ 60 male and 77180 female survivort of which 28* of the males and 20% of the females developed lung tmors. !27 Species : bat .io. /Croup : 10 Duration: Acute Kefertnce So.: 1 7 (Hapan, E .C ., e t a l . Food CoSmct. Toxicol. 1967) Species : Kat (Osborne­ Sendel) Route: Oral So./ Croup: 20 (10M L 10F) Vehicle: Diet Duration: 13 weeks Control: Diet 810m ' . Methyl anthranilate was administered a t diotrry concentrations of 1,000 *qd 10, COO ppm (approximately equivalent t o 8 daily intake of 50 and 500 q /k g i n a d u l t r a t s ) t o weanling Osborne­ Mendel r a t s f o r 13 weeks. Xo effect ras seen on g n n t h or hesatology, .IS determined by an examination of white and ("?< I. . red blood c e l l count, Iwrtoglobin 8nd hematocrit, i n e i t h e r group. So gross ;$ tissue changes uere found i n e i t h e r group, nor uere any microscopic changes d d observed i n t h o high­ dose gmup. 28 Reference No. : 30 (Jenner, P. M., e t a l . Food Coraet. Toxicol, 1964) Species : Rat (Qsborne­ libndal) Route: Oral (intubation). No. 'Group: 10 (SM 6 SF) Vehicle: Seat Duration: Acute (14 day Obsenration) Control: Not Specifid f u t d r a t s up3 8 h l a t .d to bo 7910 &kg (9S\ C. L. 1500­ 3400 'mgjkg). Syaptom of toxicity includod depression, c o u upd death vithia 1­ 2 days. The oral LD (titchficld­ WilcoxQn) for. methyl anthranilato in 18 hour Reference No.: . 30 (Jenner, P. N., e t a1. F c o d Cosset. Toxicol. 1964) Tho oral LD (tiidfield­ Nilcoxon) for ­thy1 mthnnilato in 18 hour fast& pucnea piat YU calculated t O be 2780 rg/ kg (9SI C. L. . 2210­ 3500 8g/ kg). SpptoM of toxicity included depression, gasping, rapid respiration, sutro­ i n t e s t i n a l i r r i t a t i o n and death vithin 4 hourr t o 4 days. 29 Sme of Substance: E W L ILYIHRAh'liAfE [2 ] Reference KO.: 17 (FW Cnpubl. Rep., 1977) Specjer: Nouse. . ro./ Cloup: 10 (W 6 F) Durrtron: Acute &l i t e :. Oral (intubation) Vehicli. Not Specified Control : Not Specifrd The oral LD for ethyl anthranilate in mice w a s reported t o be 3.37 ml/ kg (958 C. L. ao2.78­ 4.60 ml/ kg) . Referencr No. : 42 (Opdykc. D. L. J. F& d Cosoct. l o x i c o l . 1976) spiciss : Rat Route: Oral No./ Group: Not Specified Vehicle: . Sot Specifid Ouration: Acute ., Contrcl : Sot Specif id &'kg (958 C. L. ­'g. Y­ 4.18 g/ kg). The oral LD for ethyl mthrmilote i n r8: s YU reported to be S, 7t ,. 3 0 '. X'irme of Substance: ETHYL AXRiRAI; I! ATE {2 ) Reference KO.: 1 7 (FDA. Unpubl, Rcp. 1977) .Species: PWse %o./ C, roup: 10 (N 6 F] Durrtlon: Acute Route:. Oral (intubation) V2hicI. a. Not Specified Control : Not S p e c i f i d The or81 LO for ethyl anthranilate in mice u u reported t o be 3.57 d /k g (958 C. 1. 3° 2.78­ 1.60 81/ kg). Referenca. No.: 42 {Opdyke, D. L. J. FoodXosaet: Toxicol. 1976) spocia: Rat Route: O r a l No./ Croup: Not SpUlfied Vehicle: Sot Spwified (kntion: Acute t o n t x l : Sot Sptcif id me oral LD for achy1 urthrmilate in r8: s v u reported t o be 3.75 &kg (95% C. L. ­sg. 32­ 4.18 g// kg). 30 i N .u of %brturco: S u n & AMHRAN: uT€ [4] Reference No.: 38 (Opdyke, D. L. J. Food 6 % Spec ics : Rat. No./ Crouy: Not Specified Owation: Acute ~h r oral for butyl anthranilate than 5 p/ kg. Cosmet . Toxicol. 1975) Rout e : Crol Vehicle: trot Specified , Control : Not Sp­ ified in rats vi& reported t o be greater Samo o f Substance: LIMLYL LiNlXIHRASIUTE [7 j Reference tio. : 41 (Opdyke, D .L .3 . Food Comet. foxicol. 19'6) Species: Rat SG. iftoup: >kt Specified Dura ion : Ac ut e Route: Oral Vehicle: ,Uot Specified Control: Nor SyccifirZ '. L' I 32 I Naae of Substmci: PHENRhYL ANTHRASIUTE 191 Reference No.: 43 (OyrtyLc, D. L. J. Food Cosmet. Toxicol. 1976) Species : Rat No./ Group: tiot Specified &ration : Acute Route: Or01 Vehicle: " Kat Specified .Control : Sot Specified oral LD for phenethyl anthturilateain rats w a s reported t o be greater than 5 24,. I I 1 Nsme o f Subrtuce: ClNNAHYL AlSTHSWIUTE [lo) Reference do.: S j (Stoner, G .D ., etoal. Cexer b s . 1973) Species : Mose (NHe) Route: Intraperitoneal Duration: 8 weeks (24 week observation) Contml: Tricaprylin alone N o .i C ~p : :# O (194 I 1SF) Vehicle: Triuprylin Mice were injected intraperitoneally with 24 doses, either 0.1 g/ ky or 0. S g/ kg, of cinnllpyl ant). zonirate i n t r i c a p x y l i a 3 times Fer week for 8 weeks ior a t o t a l dose of either 2.4 or 12.0 dkg. At the higher dcse, 1S/ 15 mala and 13/ 15 fe­ les sunived the treatment, bhile a t the lower dose the survivors wero 13/ 15 males and 13/ 15 females. A t the end of the 24 week test period, I4 males (93t) and 7 females (S48) had developed lung twrs a t the high dose and 7 (47%) moles 1nd. 6 (468) ­females had af t h e lower dose. K i t h t r i c a p y l i n ­alone there were 77/ 80 male ann 77/ 80 'female survivors of which28% of the . des urd 20% of the females developed lung tumors. Reference No.: .39 (Updyko, D. C. J. Food' Cosmef. Toxicol. 1975) Species : Rat No./ Croup: Not Specified Ruation: Acute Route: Oral . Vehicle: Not Specified Controi: Not Specified I Name of Substance: WEIIML I\" MET" niRAKIUTE [12] Reference No.: 18 (F. D. R. L. 'hpubl. Sep. 19s;) I I One a d u l t r a t each was adainistercd .orally (stomach tube) a 1.0, 5.0 or SO mg dose of methyl N­ methylar! tnranilate. Analysis of the 24 hour urine revealed unsytcified amounts 0'' S­ merhylanthranilic acid ar. d anthranilic acid i n a r a t i o of approximately :O i l . 7he authors concluded tfiet ingestlot c f methyl N­ mathyl. anthnnilote is followed promptly b) d e e s t e r i f i c a t i o n w i t h t h e urinary elimination principally of the X­ methylated acid. Reference No. : 46 (Pelting, e t 01. Unpuol. Rep. ) Metnyl H­ ut­ thylanthranilate a t concentrations ranging' from 25 t o ­ 260 p p ~ i n physiological saline nas i n j e c t e d i n t o t h e duodenal lmcn of male guinea pigs a t a dose volume o f 5 .ml/ kg boiyweight a t o rate o f 6 mllmin. A ligature was t i e d around t h e duodenvnr n e a r t h e p y l o n s t o p r e v e n t r e g u r g i t a t i o n i n t o the, stoaaach. Samples of portal blood were taken a t 2, 5 ,. ?O. 20 and 30 minutes and analyz­ ed for unhydrolyzed e s t e r . TBe r e s u l t s i n d i c a t e t h a t . methyl fz­ methyl­ a n t h r m i l a t e is rapidly .absorbed a t a l l c o n c e n t r a t i o n s and i n a conp: ctcly hydrolyzed form at 25 ppo. So unhydrolyzed e s t e r wits detectable 10 minutes a f t e r i n f e c t i o n of the 40 pym solution and 20 ainutes after injection of *he 120 ppm s o l u t i o n . w i t h t h e 260 ppm solution a peak concentration of ?.? 6 ug ester/ rpl o f blood uas r e t c h e d a t t h e 3 minute sampling and a ­concentration of 0 .~6 ulJm1 remained a t t h e 30 minute sampling. Reference No.: 25 (Grundschober, F. Toxicology. 1977) ­ Methyl N­ methyla& lirurilate at a concentration of 15 o r 250 ul/ i.. was i n c u b a t e d i n 0. SU phosphate buffer (pH 7.5) at with tither pancreatin, p i g 3ejunwn homogenate or p i g liver homogenate for 2 hours. G U x a l y s i s revealed 0 , IS and ,99% hydrolysis, respectively, of t h e ester. 35 . ­. Name of Substance: MERfYL N­ CIE'MYWJRRANILATE [I t ] Reference Yo. : 18 (F. Q. R. L. U~ publ. Rep. 1963) One human volunteer vas administered orally a single 150 mg dose of methyl X­ methylanthranilate and urine w a s c o l l e c t e d a t 7 hours following treatment. Analysis revealed unspecified amounts of N­ methylantkranilic acid and anthra­ n i l i c a c i d i n a r a t i o of approximately 20 :l. The authors concluded t h a t inges­ t i o n of methyl N­ methylant5ranilate is foliowed promptly by deesterification with the urinary elimination principally of the N­ mccnylated acid, . . 36 Reference No.: 4 (8ar, F. and F. Griepetltrog. Xed. Ernachr. ,196;) Species: Rat Ho./ Group: Not Specified Duration: 12 weeks Rout e : Oral Vehicle: Sot Specified Conrro 1 : tiot Specif id For. 12 weeks, rats uere administered daily a 20.3 mg/ kg dose of methyl N­ methylanthranilate by gastric intubation. No adverse toxic effects uere aoted. Reierence No.: 23 (Gaunt, I .F., et a l . FoodCosmet. Toxicol. 1970) Species: Rat (CFE). .Route: Oral­ No./ Croup: 30 (15H 6 15F) Vehicle: Diet Duration: 90 days Control : Ciet alone MetSyl N­ met? tiylanthrar. ilate w a s added t o t h e d i e t of rats at levels of either 300, l? 5U or 3600 ppa (apprOXimiitely equivalent t o a J8ily intake of 15, bo or 180 mgjkg) f o r 90 days. Measurements of bodyweight urd food intakes were recorded regularly and no significant differences between t e s t and con­ t r o l s were noted. ilematological examination revealed a slight but significant leukocytopenia and anemia i n animals receiving 1200and 3600 ppo a t week 6, !. ut not at 90 days. The r e s u l t s o f u r i n a l y s i s conducted a t week 4 and again with blood­ Chemical deteminations 8t week 13 were within the normal limits. Measurements of organ weights revealed a statistically significant increase i n the kidaey weights i n aales receiving 1200 and 3600 ppm. Gross findings showed no evldencer of agent­ nlated lesions. ,, ' I Reference No. : 23 (Gaunt, I. F., e t 81. Food Cosmet. Toxicol, 1970) Species: Rat (CFE) Route: Oral . No./ Group: 4 (F) Vehicl­ e: Weat ' Duration: Acutr (7 day observ8tior,) Cantml: Not Specified The Or81 LD f o r methyl N­ mtthylanthranilate in fasted rats w a s repottcd t o be 2.25­ 3.38 39kg. Symptoms of intoxication included increased exploratory behavior for 15 minutes, decreased motcr, activity at 4­ 24 hours, non­ responsive­ ness to painful stimuli, piloerection, t~ loody nasal discharge, loss of con­ sciousness and death within 18­ 48 hours. Cross cxaminaticu raveold 3 slight reddening o f pulmonary tissue. .. I Saae of Substance: Reference No.: 40 (% dyke, D. L. J. Fcod Cosmet. Toxicol. 1975) Species: Rat R c u t e : C r a l So./ Croup: Sot Specified Vehicle: No: Specified Puration: Acuto Control : Not Specified 3.7 ml/ kg. The oral LOso f o r methyl N­ methylanthrPnilatt in r a t s v u ' e y o r t d t o be Reference No.: 44 (her, Species: Rat (FDRL) No./ Group: 30 (ISM 4 1SF) &ration : 90 days B. L., e t 01. Fwd Cos met . Rout e : Vehicle: Control: foxicol. .196S) Oral Diet Net alone Nethyl N­ methylurthrrnilate v u added t o t h e d i e t of r a t s a t :cvels cal­ c u l a t e d t o r e s u l t i n approximate d r i l y i n t a k e s o f 19.9. mg/ kg (M) a d 22.2 mg/ kg (F) for 90 days. Neasurunents of bodyweight and food consumption uere recorded regularly and nc significant differences between test and control r a t s were seen. Hematological examinations and blood­ chemical determinations .conducted a t weeks 6 and 12 revealed noma1 values. Liver and kidney weights at autopsy were n o r u l , and .hirtopCthology revealed no dose­ related lesions. I' I I SECTION 1V. A. ~r b 1 e IV­ I sumaarites references in the scientific literature t o the natural occurrenee of ­the substuncas i n foods. For each substance which YU found t o occur i n foods, the tab10 indica%­ the food source, .h o t h o d of detoctiar, level of concentratioa i n t h o food (tf ruportodl , and other portinent coIMllts. Ihe nfonnco nudor folloring oath entzy i n tho tablo raforr t o the bibliography nubeg usignod t o the article i n which that d8ta m u . fomd. Copies of the articlos citod w i t h English tru~ shtiont' Of foreign lmgurgo 8fliClM are in­ cluded i n Voluw 111. As previously s t a t e d i n S o c t i o a I , tho natural occulldnce of a substance in fwds indicrtes that tho substurco has bean cogmod b) humans for centuries. Where q u m t i t a t t n d a t a on t h o hV. 1 of COnCentr8tia1 are awilrble, tho level of CoWrnptiOU CIO bo ~~t i m t e d ; hheta 80 qrturtit8tiVO &t8 UOZG f m d , the o c c m n c a of a substance in a variety, of foods usually indicates that mom than . traco q& titios have bem eonsrrwd. tho~ flavor indusuy. Altho­ the tables do'not necessuily represent 8 em­ plcte l i s t i n g of a l l references t o n a t u r a l ocrurrencs, which e x i s t i n t h e l i t e r a ­ ture, 8n a t t e q t u8s asdo t o include roferenccr t o n a t u r r l occurrence of each substmco in u .m n y d i f f e m t food sources u possible. Tho d a t ~ i n t h i s t a b l e wero gathered primarily f r o m inforution pmvided by When it is s t a t e d t h r t a substance wu detected by isolation, t5is means t h r t the rCtw1 SUbStWC,. Or 8 S i q i e derivrtive, W U isolrted i n 8 relrtivcly pure torr. TIm torr "chdcaily characterized" mew that identificr; ion YU obtdnod by UI `rppropri@ to dtcdcal dotaction method. For conveni~ cr in pre­ paring tho tablo, 8 e t h e using physical wuu of deteectim, such u mixed mltiw ­points, wen included under t h i s heading. 39 . .. . Abbreviations Used In l h i s fable i : CLC gas liquid chromatography IR infrared spectroscopy W = ultraviolet spectroscopy HHR * nuclear magnetic resonance spettmcopy TLC thin layer fixautography PC .= paper chromatography E6 = mass spectroscopy 40 1 u ? 8 P 0 I 0 R ." c4 a ._ U c u U ­0 u e o *c c o o n " C 0 .­. x L ! h *­ 0 L. 0 O n L. 6 B­ ul f 4 1 . , I 42 . t SECTIQN I V. 6. . USAGE EVES FRM SURVEYS BY fE) lrr Ah0 NU TABLE IV­ 2 ­ This tablo is primrily a c o l l o c t i ~ of the most ponincnt results published in a series o f tables by tho Nationul &a& q of Sciencm md avail. blo frorr the National Technics1 Infomation Semi.­. T h e tables contain results calculated from data obtained f r o m several sources, princi­ pally f r o m tho 1970­ 71 surveys of usage conducted by the Flavor and Extract "frctumrr' Associatioa (=. MI m d t h e Nation81 Ac­ of Scioncos, Utimal Rosoarch Council (WINRC). The mothods of compiletion md coqutation aro oxplainad in dotail i n tho Addendum t o Tab12 IV­ 2 b d in sources roforrtd t o i n that Addendum. 'Ihcso documents 8%. 8vril. hlo f r o m the National Tochnic8l Infom8tion Sewice. .. Tho notes below uhich explain the entries i n this t a b l o r e f e r t o tho ~ Not.. 1 ­ This colran lists she nuL. of tho substmco and i n brackets, srople page that follows. tho nubor­ by dich t h o sub, stmco i s l i s t e d in all­ othor t& hs in this rrviw. Bonoatb tho n u o i s tho t o t a l urnwl poundage us& in flavorr. u reprtod on both tho FEN4 survey ud the NM/ NRt survey. Tho NECSINRC sub­ c o d t t e e o s t .i r t 8 d thrt tho datr reported ropnsentcd between 608 ud I O t of .tho actus1 pomd8ge rdd8d t o tho nition's ,food supply 8nausllym To astipate per argita daily intako in mg for any r3st. nce. mw the docinl point of the pom& p figure five places t o the left. TU trtrrr into r c c o ~t conwrsian factors and rn estimated b o % coverage. Ihm, 19 annual ­age of 73,300 l b s f o r =thy1 m t h m i l a t e is r p p r ~x l u t e l y equivalent t o a daily p 8 r +tu intake of 0.73300 ag. . . Note 2 ­ Tho food crtegorisr for which .usage u l t . reported aro listed Noto 3 ­ Tho n\ Pbcr of fim raportinp usage in ea& foal eitaaozy it in this colraa. Sea thq Adden­ t o t h i s table for further eqlurrtiarr. 1 .. l i s t e d hem.. An asterisk (*) indicates 3 OY f­ or firrr reported us8gom i " Note 4 ­ These columns l i s t :he weighted means of t k *usual a d r u x i u levels of use reported on the survey of usage. ' Usage 'levels were reighted wag* level reported by each f i m on a given substance w 1 s muJ. tiplied­ by a ratio ca: culated by dividing the t o t a l pounds reportad by the firm by the total reported by a i l fims. n o levels thus weighted uere s~ lppyd t o ob­ t a i n tho weighted mans. "occoadiny t o t h e annual poundage reported as being used i n foods. Each Note 5 ­ This lists the age gmup for uhich food consumption data were Note 6 ­ These colums list the possible urd potential intakes of the wad t o calculate tho possible drily intake values. designnrrrd substance for. each category by aye group. The t o t a l f o r a l l categories ­is presented a t the top o f each c o l m on a level w i t f r the nue of the substance. These intake lovels WIT calculated, a t described in tho Addenb, from usage lavolt and food COnSullptim data obtained h m surveys conductod by the Ynrket Research Corporation of h r i c a and United States Deputnent of Agriculture and are highly inflated as 8 r e s u l t of the m l t i p l e exaggercrtions b u i l t into the calculations. first; the (wslmrption is made ,,.~.. .. \: ~i? 4 that if a substance i s used i n one food i n I cotegozy, it is used i n a l l lurri foods in that categozy. . For cxnqle, if one mvfacturer reported the w e I YU i n a l l bread, cakes, cookios, etc. in the baked goods crtegozy a t the , of a substance i n cheese blintzs, i t would be assumed t h a t the ,substance s a n lovel. Secondly, i t i s usurred that the 8verrpc person eats food fmm .; 1 food categories rvry diy. This would result .in a' d a i l y i n t & of oyer . . 5,000 Calories, obviously an exrggoration. of thr usage data and the inherent ikccurrcies that exist in the. tdle. To fully understand and apprtcirte the finitations of this data, thd Addendum should be nvisved c u e f l l l y , I Iho foregoing discussion. is only a brief sumnary of t h t significance .. i .. .. 0 ­m a ... 0 ;1! 0 Y e P ". r " . i ! I ! 9 t B OD Irl id 9 CJ 5 N r cy 0 E! 0 (Y 0, n W x P 4 0 u a c a E, c Y cn 0 3 46 .. 0 OI VI y! 0 N QI 0 " I : I I g $z Q 0 . 0 " I L I I ' . .2 L . I I 1 7 I I I d 1 1 ­1 .! :; ;I i i I ! I i I ! I ! L a Y .. I 4 I I ! I I 1 " "­ " I 8 i i ! I :I I 1 I i ? I : i I 1 1 . I. i 4 i i 1 1 i i 1 ' . 1 t I c I t ! 0 0 I 49 . "" I­ ­ ­­­ ­" ­ ­ " ­­­ ­ .". "" i ­ ,"" ­" " ­ ­1 ­ i !:i i I 8 e . a I : 1 ' .I i n U I a C 1 i W V : .. .. ­. c I I I I 1 I ! I E e. i . I !* I 1 i, 4 2 B : . ­­ ­. . ­ ". ' f ­ " :+­. " .­ I 1 i " .. 1 I .e ! i I I I Ul C * 4 PI i I i t i I I I 1 I ! I i *.­ I i i m 0 I 52 ­ I" ­1 f ; I 1 ; , I . I ! I I ! ;I ­i 1 ' a i ! .) 1 I m m ! " J I .. I 1 II 9. I * i i f i 1 t I i ! ! I I i . 1 I I I ! i i 9 I 1 l 1 : e ? r i i I 'i. ! 1 , . ­j * I I 1 . c Y x ! e i VI VI I 53 1 .. ­.­ I" . ­4. I 8 i ! + 4 0 Y ? I ' i f ' 1 ! I I I . ! i i : i m *. .f i f ­ 1 1 t I i ­ i ! a . I ! YI V I I 1 i ! i I .. i .. 4 VI csi 1 54 . 1 : I i : I !. ' *I 1 i 1 I I i 1 ­ I ! 5 i f : !. I ! i I ! i I SI i . I I I !f :I si 3 I . *. .. 1 ! i I i t I ! I ­1 1 I 1 *e .. * ! I . I I I I I i I 1 i i I 1 ? 1 I ! f i ! "' ' . I 57 .. 1 .­. I f ! ,' 1 .. . i I ! * r) .. * c 1 m YI i I ! i 58 . .. . . 0 .. hl ­ 9 I­ ? w . 0 e. ­ 0 Ef 0 t­ I­ 9 w ? Y n 9 9 '? rr) N a * a 0 a 59 .. =e == .... 53". .... .... =C =t " =t ­r c ­... "" "" .... 00" .... *... o o o m m N VL c L h v1 h v) cc h ' 9 o c ' 1 c b e m .* Q 1. 4 ? f * ? '. W Y 0 0' 3 . i 60 " ' ... . .' 61 ." 6 _."" """" .. " 0 I fie purpose of t h i s ciiscussion iS to revlev in 8 cursory, m n ­t s h i c r l way, tire background, purpose, VIIUCS, and l i n i t a t i m s of a w j o r e f f o r t to gather data relating to the w e of food ingredients wtrich are generally recognized as. safe ('* GUS* '). Not only t h i s sumnary discussion. but the f u l l report­ should 'be read carefully by those intending to d e .any use of the data. 1. Background and Purpose A review of the safety and appropriate classification of substances ' ~e n e r a l l y flecognized 2s fafe" .( '',,,, 'I ('I for their intended use in food, re@ res (1) identifying each substance, A d (21 gathering for each substance all available data on its toxicity and occurrence in food:. goth kinds of dot8 are necessary, since the safety of 8 substance is detemined 3y consid­ ering both its toxicity­ how little or grtat. its inhertnt capacity, to cause h m ­a n d the amount of the substance t o vhich) uc are exposed. Determining exposwe requires two primry c. ypes of informtion: First, , hos arch of each GRAS substpnca is wed in each clearly defined food category? Second, how mch is eaten of each food category in chich thc CFUS s& stance is wed? ­ 2. Survey Procedun AS part o i thm GRAS review, a special subcorittcc of the htion. 1 Academy 'of Sciences conducted a .survey designed t o provide informtion an the probable and possible intake of such food ingredients. The subcornittee US& both its own f a c i l i t i e s and those of sever81 ifkiustxy groups.. nit took the forr of a co. plex, comprehensive survey of the chemical and food processing industries t o deterrino the exact identity +nd specifications of the subttances aided to various foods. The suney obtained confidential inforntion fro. each participating firm on erch CRM ingredient used, the f a d categories in which ~ used, and the usual a d 8aximm levels of use in e8ch food category. Respoading firms kdic8tcd the importance they attached t o each ingredient, the errliest date of use, and the pomd8ge of the ingredients they eolritted to the food (') See Glossary of Tcru f o r d e f i n i t i o n of underlined words. ­2­ supply. The survey'provlded much additional data or1 toxicology, natural Occurrence, and other information relevant to the evaluation o f safety. n, e Comaittee made use of other surveys bhich covered specis1i: ed ingredient areas., such as flavors, the ingredienrs used in chewing gwn and certain candies, and brewed oevtrayes. A separate survey covered infant foods. Thew usage data vera reviewed for consistency, accuracy, and appropriate­ ness, referred t o the originators for correction or :orfirmatier, *here necessary, tabulated i n a way t o preserve confidentiality and collated to provide informa­ tion of more direct value in safety evaluation. In order that information on the amounts of each ingredient used in food be applied to the ­estimation of possible human intake, the Committee obtained from t h e Market Research Corporation of Anri'ca (bRCA) data from a survey of frquency of consumption of a l l food i t e m eaten In or away froa home. nese data were r5classified to f i t wizhin the food categories crployed in the Academy survey of ingredient usage by the food industry. Data on portion size obtained from a US9A survey were employed t o complete t h e c3lculation of .. "average" and "high" coalsumption of each fooci cakcgory­ used in the survey. me data finally present. ed on each GUS substance included weighted Lcans of the wuai and maximm &e in each food category, potential "average," and high intakes from each focd category and the tot81 diet by age, total yorradage used in the food supply, technical effects for which used, and industrial importance. 3. Scope of the Survey Within the limits of 8vailible tire and funds, the Comittee concludcd t h a t t h e survey achieved its intended purpose. Consistent and apparently valid information was obtained from firms responsible f o r 60 to 70 percent of the nat. ion's processed food supply (andeven a higher percentqe for flavors utd certain specialty foods:. 4. Valuer ­ mere s w e y s provided the first n l i 8 b l e d a t a on the levels and r b c r of use of oost ingredients on the original FD4 'White: Listn and those used by prior sanction. I t generated ve­ ry useful detailed information, including re­ . checks, on :he highest wages of ingredients, and the foods in which such @". ,. k j" ­. r*.+$ >, high levels ocrwrred. ­ .?"­ '. L. 63. I . .I I I Ir ­_ . ­ ­,. ­ The survey shows uhether a, ri ingredient was used by m y f i m s o r only a few; or used i n many or few food categories. A related concluslon to which the surveys point is the familiar, but frequently ignored, need to achieve variety and balance in and t o avoid an excess The surveys also on t h e amounts used in use can be estimated. is an extremely useful of other data. the diet as t h e best way to insure adequate nutrition of any ingredient, whether naturally occurring or added. provided data on the importance of each ingredient, and the total f& d supply fromwhich average per capita While not directly valuable in safety evaluation, this bench mark against which to compare the reasonableness These efforts provided inforubatio; l which is less than pcrfsct; but the best available on food consumption by current categories of processed food andby age. Furthermore, these new results 2rovide consumption data for those individuals who, "eating in a rut," consume a ?articular food category more often than 90 percent of the population. The proccdtxes wed. in these surveys have resulted in several 'benefits. Among these are a consistent, comprehensive clas. sification of "technical effects" for which GRAS substances and food additives are &. xi, and the , definition of food categories mre adapted t o modern processed foods than the traditional nutritional. or commodity classifications. The results of the survey will be of substantial value in providing for industry guides t o good manur'act\ uir, g practice i n ingredient usage. Finally, it is c l e a r t h a t t h i s aust be'a recurrent, orderly process, and these sur­ veys have set a useful pattern for the future. . , 5. Limitations, Cautions, and Restraints Though valuable, these survey data a r e cocsplex and subject t o a number of uncertainties. To mderstand their values and 'limitations and avoid mi$­ ,interpretation and invalid conclusions, those who wish to use the information in the exhibits or the tables should first read thoroughly the report urd exhibits prepared by the Committee. The most inportant caution t o be observed is t o k g n i z e t h e cumulative effect of the several conservative assumptions mdt in the coqilation of t h e ­ data. The result is a substantial over­ estimate of possible intake. The reported data indicate usage in some food­­ rarely a11 foods­­ in a food cotegQry. i,, '­ I 64 . ­4­ Such d a t a a r e v a l i d o n l y when and i f the ingredient is acxual! y used i n ­ t h a t category; yet the calculations conservatively assume usage app; iet to a l l foods in a' category. Furthermore, an ingredient may be partially lost in processing due to evaporation, washing away, or other causes. The survey can only indicate indirectly whether a particular ingredient is used i n many foods within a given food catsgory, in uhich case there would usually be mjny responses on that ingredient, or is *sed only in a feu foods (usually specialty foods). Fdr example, the use of sulfur dioxide is conftned t o sow d r i e d f r u i t s . I t is not used in fresh, canned, o r f r o z e n f r u i t s ­or juices. Caramel is used o n l y i n some gravies, not in cream and other sauces; yet its level qf use, only in those fords in which it is used, could be taken t o a p p l y to the whole sauce and gravy category. Such e r r o r s should be avoided. Uhether an ingredient is used i n many or feu foods within a category depends upon t h e a v a i l a b i l i t y of alternative ingredients. NO, or few, a l t e r ­ natives mean wide use. Many alternatives rean g r e a t l y r e s t r i c t e d we, although t h i s is not clearly apparent since the reported level of use sppears :o apply t o a l l f c o d s i n a category e v a though t h i s would seldom, if ever, be the east. A d i s t i i l c t i o n must be drawn between those tables based on the frcquency with which foods are consumed by the average of the total populatiar ('Total Sample") as compared with those tables (" Eaters­ o n ) which are based solely on those who consume the food a t some time withir. the suwey period. The l a t t e r d i s r e g a r d s t h o s e i n the population who d i d n o t consume the food during t h a t p e r i o d . (Consumption of any one food category reduces the consumption of other food categories due t o r e s t r i c t i o n s rn t o t a l a l o t i e intakt.) ­Thus, levels of conslmtption based on "Eaters Only" can be valid only for s i n g l e o r a few food categories. "Eaters Only" intake figures cannot b, e added across a l l categories, since no one eats everything. Such an assumption rould r e s u l t in a wholly impossible total calorie intake. n e same l o g i c makes the levels in t h e "E a t e r s W y " t a b l e s n o t u s u a l l y a p p l i c a b l e even to a l l foods within a single food category. From t h e l e v e l o f each ingredient used in at least .some foods within each food­ category, the frequency with which each category is consumed, and the portion sire when consumed, the tables calculate the possible d a i l y i n t a k e of the ingredient through each food category. The sua of such ­possible intakes fTW a11 food categories Frovides an estimate of possible ­ 65 . .. t o t a l d a i l y intake. For the reasons just discussed, t h i s estimate is u s u l l y hizhly inflated. The extent of such inflation can be gathcred by comparing that figure of possible d a i l y intake with the­ per capita daily intake obtarned fTOP the .poundage figures committed to food, the coqletencss factor of t. le survey (a t l e a s t 60 percent), and the population.") Tht ratio is low i .e ., ­ . tha exaggeration of possible daily intake compared with the per capita is satall) uhcre an additive is broadly used and where there are feu alternatives. The r a t i o (the exaggeration) is high where an additive is u s e d . infrequently, as only in specialty foods, o r where there are many alternatives for obtaining the same technical effect. h e cannot take the possible or ­potential daily intake, even khat is perhaps misleadingly called the flaverage, l' from the "total sample" table, a l t i p l y by the population and the days per yeor, and expect to obtain the annual food us0 of an ingredient. This is an impermissible us8 of the data because of the multiple exaggerations reviewed above. The intake tables inevitably reflect s a c p o i n t a t the upper tail of the distribution curve. From thi's it follows that the intake values labeled "high" or '% e.:, high" could be obtained only as a result of a highly improbable combination of circumstances; selection fror food Category of arly those foods contain­ ing a particular ingredient, no ­toga or loss o f the ingredient, cons­­ tion of the food category at m t u w l l y high frequency QI high levels of llsa of the ingredient or both, and no 1st of alternative ingredients. Irrprobable in itself for one fwd categor/, this is virtually inpossible for more than a feu food categories simltaneowly. Because one could not possibly seek a11 possible technical effects in . a single hod, and because of the multiple alternatives frequently available, one cannot add a11 substances used in any f+ category to obtain the totof amount of substances potentially occurring a t one time in any t00d or category. lack s t a t i s t i c a l s o l i d i t y and refiect very limited, therefore mrnetim. S extreme, we. The data base for some food categories and Copulation GOUPS is also narrower than ­the i d u l . The figures indicated by asterisk t o signify three responses or less This is the NAS 11/# 2 ratio in Exhibit. 58. .... .. ...... "7' '7 ...... ­0­ Is is clear there is nc! final Lay to be absolutely certain of either accuracy, or completeness i n t h e survey. Overall, the survey is as complete as uas practical because of the diminishing returns €or add'itional effort expended. 6 . Qgortmities Tkis survey points out the desirability of having (1) better food eon­ sumption rather than use or disappearance data, (2 ) more exrensive analysis of foods to establish what colPponents remain i n them r e l a t i v e t o what was introduced, (3) determination of the effects of preparatim and p l a t e s a s t e on ingredient loss, (4) better understanding of 'food category use by specific population groups, (­ 5) estimates o f intake from a l l sources, natural and added, : and (6 ) future surveys t o r e f i n e amd *date these­ data, The present inforiation deserves substantial additional analysis. A cursory inspection reveals food c o n s q t i o n patterns in processed foods uhich are age­ dependent o r o f n u t r i t i o n a l i n t e r e s t . I t seems probable t h a t t h e . ingredients used for different technical effects tend to group within definable wage and t o t a l a n n u l poundage levels. As examples, salt m d t h e t h r e e , sueeten. ers­­ sucrose, dextrose, and corn syrup­­ make up the four most .u s e d GRAS substaxes. Flavors constitute the bulk of those as& i n least voluae. A better appreciation of such patterns of w e could lead to an aderstanding . of where it would be desirable from e i t h e r . an economic or a public health point of view to concentrate research on new alternatives. 67 (; LOSSXRY ACCEPTAPLE DAILY INTALE .( AD?) Daily dose of a chemical that appears to bc without appreciable risk on the basis of a l l the facts knom a t thc time. "Without appreciable risk" is taken t o mean the practical certamty t h a t injury will not resuit even a f t e r a lifetime of exposure. ANNUAL POUNDAGE The t o t a l number of pounds used per year by'each participating firm or ih t o t a l by a l l r e p r t i n g firms. .. AVERAGE DAILY INTAKE > Estimated amount of a ($ AS substance that may be ingested daily through consumption of foods to which the substance has been added. CONSWION LEVEL The level, i n grams per QY, of a food category consumed by the rveragh person (" total sample") or consumed only by those who, within the sur­ vey period, ate food from that category at least once (" eaters only"). DAILY INTAKE See CONSfp( PTI0N LEVEL. FAO/ nm> JOINT EXPERT ' C W f l T E E A committee of toxicologists and o t h e r s c i e n t i s t s .appointed for their individual qualifications and not representing government agencies or industries. Brought together =der the joint sponsorship of the Food and Agriculture 'Organization 'and the World Health Organization for the purpose of defining specifications for food additives, appraising their safety­ in­ we, and setting such limitations or requirements for further information as seem appropriate t o them. FEMA Flavor and Extract Manufacturers' Association. .. FpW GRAS LIS Set GRAS LIST. .. a . f" ­8­ The food at consumed distinguished fro8 intermtdiate and incoaplete stages of processing or preparation, such as dry atixes, concentrated syrups, ray meat or vegetables, etc. FLAVORING ADJUNCT A substance which does not itself contributc flavor, but which is used in association u i t h flavoring ingredients t o improve their effectiveness in use. This includes .solvents, fixatives, hntioxidantt, etc. FLAVORING ADJWAHT Synonym for FLAVORING ADJUNCT FUVORINC INGREDIENT oft& simply called a "flavor," is any substatce added to food, ;Irugs, or other products taken i n the mouth, the clearly predominant purpose and effect of which is to prqvide a particular flaror in the final product. "1. a: miterial consisting essentially of protein, carbohydrate, a d fat used in the body of an organism t o sustain growth, repair, and v i t a l processes and t o furnish energy; also: such food together l l f h supple­ mentary substances (as minerals, vitamins, and condiments)" This is used here in the sense of human fodd. In the law, the term ** food**. includes beverages, chewing p, and the componenu of ail food articles. FOOD ADDITIVE General Definition ~n y m i i g r e d i c n t added t o food, or residues ofwhich are found in fwd, resulting fro. its use to achieve a particular technical effect. (2)­ . . Leg81 Definition ­ ** Any substance the intended use of which results or m y reasonably bc expected t o r e s u l t r d i r e c t l y o r i n d i r e c t l y , in its becomiag 8 corponcnt or othemise affecting the characteristics of YIY focd (including my substance intended f o r use in producing, manuf8cturing, packing, pro­ cessing, preparing, treating, packaging, transporting, or holding f&; and bcluding any source of radiation intended for any such use), if such substance fr­ not generally recognized, among experts qualified by scientific training and experience t o evaluate its safety, as having been adequately shown through sciemific procedures (or, in the case of a stance used in food p r i o r t o January 1, ­1958, through either s c i a i t i f i c procedures OT experience based on co­ n use in food) t o be safe under the conditions of its intended use; ... .'* (l) Webster'$ Seventh New Colltgiate Dictionary, p­ 324. Springfield, Massachusetts: G. 6 C. Merriaa Company (1969). ­9­ AJI act of Congress, parsed in 1958. amending the federal Food, Drug, acd Cosmetic Act. The amendment established' requirements for premarket clear­ a?:=; f o r safety and functionality o f . a11 substances intended for use in food h i t h certain exceptions. The exceptions include substances that qualifjcd scientists generally recognize as safe, other substances covered by a '. prior sanction" (q. v. 1, color additlves, and pesticidal residues, f OCQ cATE03RY One of 34 categories into which a l l foods haye been classified. for the purpxe of t h i s survey. Categories consist of foods closely related i n purpo,~, structure, process, composition, 01 propcrties. GOOD MANUFACTJRXNG PRACTICE Procedures, facilities, quipment, and personnel training, whichtoken togethex and properly applied, define the conditions for safe and effec­ tive processing of food. GRAS The acronym for *'generally recognized as safe." it is a s l i g h t ad; pta­ tion and incomplete rendering of the language of the Food Additives hzdment of 1958 to the Federal­ Food, Drug, and Cosmetic Act. I t r e i r r r to I*. . . t substance . . . generally recognized, among experts qualified by scientific training and experience to evaluate its safety, w having been aCequacelY shown . . t o be safe mder the conditions of its incended use; . . ." '17s total, much longer definition. is gwen i n Section 201 of the Act. (See also FOOO ADOITIVE.) GRAS LIST A a&, used, but. rnaccurate term f o r all substances used in food an the basis that they are GRAS, rather than regulated additives. There has Tot been .any single "GRAS List." The FDA published two intentionally incoaplete lists ('White Lists'3; the flavor and chewing gum industries pub1 i s h 4 8 series of lists (the "FEMA GX4S ?. ist* '), the brewing industry pmpared a coqrehensive unpublished list, the FDA presmed some sub­ stances t o be CRAS without publication urd issued "no objection letters," usually tmpub1ishcd. m feet other substances, and thert undoubtedly were, as the law allows, some private, rnputlished determinations that a use of a particular substance was WS. Aside from these groups, USDA and FDA had i n earlier y e n s approved Dy "prior sanction" a large number of substances not necessarily covered by thr; e l a t e r GUS actions, IMPORTANCE Commercial importance in the sense o f how unique are the properties of the ingredient, and how easily can it be replaced by another ingredient or change of process. \ ...... I INGRED I ENT A component Or constituent 3f food. The term is usualiy U J ~ in the sense of an ingredient vhich is mtentionally made a part of food. . Cozstituent often mans a naturally cxcurrkg component. WIMJN USAGE LEVEL Highest level used in any product. WEA? ' INSPECTION ACT kr act of Congress originally passCp in 1907, amended and extend4 to permit continuous inspection of neat slaughtering. and processing est&­ l i s b e n t s by employees of the Dcpar­ tmnt of Agriculture. HEDUN USAGE LEVEL The usage level of a particular ingredient in a food categor), uhich f a l l s in tho middle of the reported uses; i. e.. half the wes are reported a t a lower level and half the uses, a t a higher level.. . " NAS ,. National Academy of Sciences. NDN­ USER FIRMS Firms uhich. mnufacture or distribute, but do not cornit the kyr& ieat t o food. Letters issued by FDA after 1958, by which FDA indicated that there would be no objection posed at the ti­ of the l e t t e r to the w e t; food of the ingredient or ingredients named therein in accordance ­ . with the. uses outlind. Offensive to the sense of tsttt or me11 and therefore inedible; usually usel t o refer to 1 food which is spoiled or overflavord. .. PER CAPITA DAILY INTAKE An average figure derived by simply dividing annual national food use of an ingredient by the population and days in a year. PORTION SIZE A figure derived from estiuutes of nean food consumption using "total ­le'* (see def'nition o f CONSUMPTIC3 LEVEL) and average food additive use for each foot category, described in Tables i3A and B IS "aver: lge intake level. '' Bccause or' a series of conservative assumptions (see, discussion in report), t h i s reprtsents J pgssible intake that would only infrquently be achieved. POTENTIAL MILY INTAKE A figure dcrivcd from estimates or' food c o a s q t i o n based on "eaters only" [see definition of COPISUHMION LEVEL), or the 90th percartile frequency of consurption, or higher levels of hod additive use., or some co. bination of these for each food category. These are described in tat tables as ''High A," ''High B," or "Very High," or "Eaters Only.** In addition t o t! w conservative assumptions inherent in ­the calculation . intskes mlikely for .ore thar. one or a few food categories. WL'TRY PRODOCM INSPECTIW A r c f . . of 'possible" if. tOkCS, these additional factors =de the potential 1 This ­5 M 8 C t O f COngrCSS passed in 1957 t o provide for the inspec­ tion of poultry and poultry products and otherwise rcgulatiag the pro­ .n.­" cessing and distribution of such articles in interstate copmerce. ;=.>< Ld f \., PRIOR SANCTION Action prior to 19S8, by the FDA or USDA. to p e d t 8 substance to bo usd in food ­der the Food, Drug, and Cosme: ic Act, the Poultry Products Inspectiat Act, or the M e a t Inspection Act. SPECIALTT FO0OS Foods of iiritrd appeal, usually to particular ethnic, economic, or , geographic groups, often mote expensive and limited_ in distribution and conswption.­ Th. tern irplles lack of broad appeal or frquant . US.. The rchitvicg of 8 desired characteristic in a food or food manufactw­ ing process. For euPpla, 8 desired nutritional content or.­ antioxidant in a food produet; ws* of removal f r o m a baking pan; or ease of extm­ sion for pasta product. see cotlsw1oN LEVEL. Capacity of the substance to produce injury. '&% e term includes capacity t o induce teratogenic, mutagenic, and carcinogenic effects. 72 ­ 12­ Refers t o "Food Intake and Nutritive Value of Ilietr of h, b m , a d chihirea in t h e United States, Spring, 1965, '* a preliminaq report by' the Gaasuvr and Food Economics Research Division, b r i e u l t u r i l &sar& Service, hit4 States Department of Agriculture (sea Exhibit 328). ,. USER FIM Nom1 or average concentration roughly weigh4 by amur1 prodwt VOIUC. YEIQITU) MEAN USAGE LEVEL 'The average level a t which a p r t i c u l a r ingredient, if it is ~4 , is added to foods within a fwd category weighted in proport' &on to the VOIWC of the additive used by each firm; e. g. , a firpl Vhia wed a mil lion porurb of an additive coats in the average one Wrtd t i a c t =re thrn 8 fim which uses o l y lO,, OOO pounds. The bibliograpky presents a c ' q l e t c l i s t i n g o f a l l l i t e t q t u n a r t i c l e s and references used in the preparation of t h i s r c i e n t t z i c l i t e r a t u n r e v i a . me e n t r i e s i n t h i s s e c t i o n ire l i s t e d i n alphaLetica1 order, by nane a f the principal author: The bibliography include a l l a r t i c l e s 1cca: lti i n the literatwe sear&, whether o r n o t i n f o n n a t i m f r o m those arti: lrss w. u included in the literature review. Those references denoted by a tingle asterisk (*) are a r t i c l e s c i t e d within the literature review, ad references denoted with a double asterisk (0 0 ) are a r t i c l e s cited within the S m r y portion of the review, in Section I. Y d u m e t 11 and 111 contain copies of a l l c i t e d a r t i c l e s , inclvding ­. . . English trans! o: ions o f f o r e i k language. articles. .. 1. 2. 3. 4. +* 5. 6. 7. ,. +* 8. ' 9 , 10. 11. ** 12. 13. +­ 14. Andrcvs, B. D., A. J . Poyaton, and I. 0. Rat. 1972. Aromatic a i d e r . VII. Steric hiadrance to hydrogen bocding io o­ substituted acetanilides. Auat. 3 . Cheg. 15( 3): 639­ 646. Arctander, S. 1969. Perfume and flavor chedcalr, S. Arctander, Moatelair, N. J. Vol. 1 and 11. Barbaa, S. I., N. S. Karavya and U. S. Ilifnavy. 1971. Study of cue peel ailr of lemoa, lima and mandarin groviug i n Egypt. Ip. Prrfm. Corret . 86: 53­ 56. Bar, ?., and e'. Gricpcatrog. 1967. Vherc & rtaad coacrrning the evalurtioa of flavoring rubrtanccr frcm the viewpoint of health. Ktd. Lruaehr. 6: 264­ 251. Brom, P. E., m d J. X. Price. 1956. Quantitative studirr ah metabolite~ of tryptophaa in the urine of t h e d o 8 ,­c a t , rat, and un. J. Diol. Cha. 219: 985­ 997. 1 i CaIvarano, 1. 1968. q t a l i u r p e t i t g r a i n o i l . 11. Eiiar. derrrd bergamot petitgrain oil.. Esreare Deriu, a r m . 33( 1­ 21: 3143. Carcoavt, P., and I . florun, 1974. On the ecnporitim of ­the uma of black tea. V. Helv. Chim. Acta. 57( 25): 209­ 211. Charcoanct­ Earding, f ., C. E. Dalgticrh, and A. ileuberger. 1953. The relation bctwea riboflavin and tryptophan rctabolirr, rtudied in the rat. Biocbrr. J. 53: S13­ 521. D i C i a c w , A. 1967. Citrur errmtial oil;. XXIX. Riechrt., hr­ n, Koerprrpflrga. 17( f1): 460, 462. Drauert, ?., urd A, von Rapp. .l% 6. The' componcotr of rurtr (grape j u i c e r ) and wincr. VIf. C u Cbra8tOgr8phiC invtrtigatioa of a r a a t i c r u b r t u ~c e r i n vi­* and tbeir bi@ gencrir. Vitir. 5: 3S1­ 376 . Drawert, ?., and A. voo Uapp. I%& Car chraatograghic malyri8 . of plant araar. I. The enrichment, reparation, and identification of v o l a t i l a arm. rubatancer i n grape mrtr aid vines. Chromato­ g r q i d & 1: 446­ 457. Ekman,. B., and J. P. Strabcck. 1% 9. The effect of some rplitproductr of 2, .3'­ acotoluene on t h e u r i n a r y b l a d d e r i n t h e rat and t h e i r excretion at wriour ,dictr. Acta Pathol. Xicrobial. Seand. 26: 467­ 471. Sracntial O i l .Arroeiatioo of U. S. A., fnc. 1970. MIA rpteificatioor and rtandardr. #cu York, Reu York. m, 1974. S c i e n t i f i c l i t e r a t u r e r e v i e v of aliphatic pr, imary aIcoholr, aldehyder, aeidr and id :era i n f l a v o r usage. Vol. 1­ VLI, Publiahcd by 0. S. Food md Drug Admamiatration, Yarhington, D. C. 7s 15 16 17. 18. 19. 20 21 . 22 23 24. 25. 26 . 270 28 . 29 FEU G U S Subrtance8, 1965­ 18. Recent progrerr in the coaridtratioa of flavoring ingredients under the food additives onendment. CRAS rubrcancer. A series of 9 articles publirhed i a Food technol. 19( 2, part 2): 151, 1965; 2 f O ):?S , 197C; 2 O (5 i :3 5 , 1972; 27( 1): 64, 1973, 27( 11): 50, 1973; 26( 9): 76, 1974; 29( 8): 70, 1975; 31( 1): 65, 1977; 32( 2): 60, 1976. Fieldr, E. K. 1971. Xethyl anthranilates. U. S. Pat. 3,625,389. Food m d Drug Adminirtration. 1977. Swmrry of toxicity &ti. Unpublirhcd Repoct. Food a d Drug Research Labotrtoticr, Ine. 1963. Hetabolic fate of methyl o­ methyl anthraailatc. No. 84919. Unpublirhed Report. Food Citemicala Coder, 2nd ed. 1972. C­ ittee on specifications. Food Chemicals Codex of the Camittee of Food Protection, Uation. 1 Research Counc'il; National Academy of Sciences, Yashington, DC. 1039 p p o Poreiaa C­ pound Hctrbolia ia Mmmrlr. Vol. I. 1970. Vol. 11. 1972. Vol. 111. 197s. The Chemical Society. Burlington Roure. London. Puria, t. B., and W. Btl~ mer, cd.­ 197s. Fcnaroli'r handbook of fl. vot ingrtdieats. 2nd ed. Vol. 1­ 11. The Chemical Rubber Company, Cleveland, Ohio. Cabel, L. P., and U, R. J. Sirpron. 1972. Dialkyl ­ cliaubrtitutcd 4 ­ ~~ hydroxyalkyl) amino)­ quinazoline nitrates. U. S. Pat. 3,637,699. Gaunt, I, l!. .Sharratt, P. Crarro, and X.. Uri8br. 1970. Acute and rbort­ term toxicity of methyl­ U­ mcthpl anthranilate ia rats. rood Cornet. Toxieol. 8( 4): 359­ 368. Civaudan Index, 1961. Specifications of ryntheticr m d isolate8 for perfmery. 2nd cd. Civaudaa­ Deliuiuna, fnc., New York. _. 431 pp* Grundrchobcr, I, 1977. toxico~ ogic8l asrcrrocnt of flavotiry esters. T O I i C O l O u . 8: 3870390. Cuentbar, t.. 19SO. The errentirl oils. Vol. I­ IV. D. Van Rortrrad Coaparf, Inc. Priacetoa, Rev Jcrrey. Hagan, C. C., Si. %. Ranren, 0. 0. fitrhugh, P. W. Jcnner, W. I. Joner, J. ll.. TayIor, E. L. Long, A. A. Nelson, and J. B. Irouver. 1967. Food C08met. toxicol. 5: 141­ 157. . euet, Eo 1968. The of citrus fruit juicer. Fruits. U( g): 493­ 471. 76 ** X. 31. 32. 33, ** 34. 35. 36. 3?. ** 38. ** 39. ** bo. 4' 41. ** 12. ** 03. ** 44. b S e ** 66. Ienner, P. X., E. C. 88g. n~ J * X. Taylor, E. Lo Cook, and 0. C. Pitthugh. 1964. rood flavourings aad compouadr of r e l a t e d s t r u c t u ~e . X. .\ cute oral toxicity. Food Coract. Toxicol. 2: 327­ 343. Kahn, J. H. (Rcvicv). 1969. Compound8 identified i n whiskey, vine, i n d beer: a tabulation. 3. Assoc. Off. Agric. Chca. 52( 6): 1166­ 1178. Kicchncr, J . G., und 3. M. Hiller. 1953. Volatile oil conatituentt of grapefruit juice. J. Agric. Food Chem. 1( 7): 512­ 518. Kugler, E.# and 3. Kovatr. 1963. Information w Handarin peel o i l (Citrus rcciculata Blanc0 or Citrus nobilir var. delicioza Suinglc "Xandarin"). Ilclv. Chim. Acta 46: 1480­ 1513. Longland, R. C., W. P. Shilling, and S. D. Gangolli. 1977. The hydro­, lysis of ­flavouring esters by a r t i f i c i a l g a s t r o i n t e s t i n a l j u i c e r md rat risrue preparation.. Toxicology. 8: 197­ 204. Warck Index ­ An encyclopedia of chemicals a d drugs. 9th edition. 1916, Herck aad. Company, Inc. Rahvay, R. 3. 1313 pp. i National Ac8dcap of Scieacrs. 1970. Evrlwtioc! of food eheucalr. Wa8hiagtoa, D. C. National Pomdrry XIP. 14th ad. 1975. Aaerican Phomaceutical Asrociation. Yashiagtou, D. C. .. Opdykc, D. L. J. 19fSa. Xonographs oa fragrance raw rateriala. a­ Eutyl aathrMilrte. lood Coatcat. Toxicol. 13: 727­ 728, Opdykc, De L. J. 197Sb. Mouographr on fragrance raw mat, erialr. Cinn. ay1 anthraailate. lo& Comet. Toxicol. 13: 731. Opdyke, b. L. 3.. 1975~. Honogrrpha oa fragrance mu materials. Dimethyl aarhrmil8te. Food Comet. Toxicol. 133791. r Opdyke, 0. L. J. 1976.. ~oaographs 00 fragrance rau materiala. C i a l y l aathrmihte. Pood Comet. Toxicol. 14( 5): 459. Opdyka, D. L. J. l976b. l4onographa 021 fragrance raw materials. Ethyl mthr. nilate. rood Comet. Toxicol. 14: 7f9. Opdyke, D. L. J. 1976~. Monographs on'frrgrancc raw materials. Phenyl­ ethyl urthtaaitrta. Food Comet * Toxicol. :& :831. Oser, B. L., S. Carson, and X. Osct. 1365. Toxicological teet8 06 flavouring aatfer8. Food Cosmet. Toxicol. 3: 563­ 369. 'Oset, B. L., a d It. L. 8.11. 1977, Criteria employed­ by tbe . . Expert P, aael of P. t. KA* for the GRAS evaluatioa of flavorizq ,rubstancta. h o d Comet. Toxicol. 15: 457­ 466. pelli­, b., lt. Longland, n. Dufltp, and S. D. C; n~ o; 1.5,­ *A . study of intestinn1 abrorptios of four flavouring caters in the guinea pig. ToxicologJl, (s u h i t t t d f o r p u b l i c a t i o n ). 77 ­. *. ** 48. Registry of Toxic Effects of Chemical SubstJnces. 1977. U. S. Dept. of Heaith, Educ8tion and Welfare. Public Health Service Center f o r .­ Disease C o n t r o l , N a t i o n a l I n s t i t u t e for Occupatimal Safety a d Health, Rackville, Maryland. 1296 pp. 49. Roger, N. F. 1961. The r e c o v e r y o f m e t h y l a n t h r t n i l a t e i n concord grape 1 essence. Food Technol, 13( 6): 309­ 314. ­­ . .. SECI'ION V I . DATA GUIDE The following guide provides a slfmrmy each substance i n t h i s S c i e n t i f i c ­ Literat.­ of various data included for Review. The principal name and FEMA number of the substance is foliowed by its synonyms. ?he Code of Federal Regulations (CFR) refereace is given for those sub­ stances publibhed by the Food and Drug Administration. ?% e range of average usual and average maximum usage levels of the sub­ stance is shown next, as u e i l as annual volumc i n pounds. These data are taken from tho 1970­ 71 NAS and FEW surveys. Tfie pur cupitq daily intakes are calculated as described i n t h e introduction t o Table IV­ 2 froa the annul MlUIDU. I f the substance has been found as a natural component o f food, this is noted a f t e r the =age data, w i t h the number of'different foods in, which the substance is found indicated i n parenthesis. Finally, a sununary of the biological data available'for the substance is listed. . The references am t o the sunme of the­ principal author and the year of tho publication for each study. lhe bibliography can be consulted .for the complete journal referbncc,. This guide has been generated by computer and is therefore printed in capital letters, with the brief descriptions of the biological data being limited t o 60 characters. uhbro Greek l e t t e r i should occur, these 8­ printed as t h e i r English equivalent followed by ui ampersand; .. i. 0. u AIL mc! A .DL. , J . VGLUHE (L E I 73300­ RAT CRAL HAGAN 6 7 FOA UR 77 r (continued on next page) <I I N V I T R G GRUNDSCHOBER 77 VL'LUCIE 4431 1784­ NArURAC GCCUHREhCt Ih FbkO ( 2) .. REFEWENCE CPOYKE 16 . .. . USE LEVEL (P P N , MAX 1.00 f O 2. so USUAL' 4­ 30 TO 2.00 S E M I 2020 dUlYL AklHRAhlLATE [J] BUlYL 2­ A* IhC& EhZCATE dlllYC O­ AMl hCdEN2l; ATE CFR 172­ 5lS FEHA# 2181 REFERENCE OPDYKE . 75 i" * 7 I .. 8 tULOG ICAL .OA rA NONE 38.00 33.33 REFERCNCE NO&€ CFR 1? 2­ 51S A&­ TERP INYL ANTHRAkIl4Tt [8 ] i FEPAr 3048 ~ TERPINYL 2­ AFINUSEkLUATf 7EAPINYL O­ Af41Ni26EhLOAlEE­ TERPINYL ANLNThRAhILlTE "SO CALLtO' P­ MEhIHA­ l­ EN­ 8­ YL 2­ AHIhCBthZCAIE P­ MEN7H­ I­ Eh­ 8­ YL AYTHRANlLAIE 8 lOLOCICA1 DATA kONE REEERENCE Noh€ .­ C F R 172.515 PER C A P I T A IFtTAKE (W /O A Y ) 0.00* 25 OPOY KE 7s 1 B I U L O G I C A L D A l A hUNL , R€ fERENC€ hONE .. f .. .. .: . I f/"# Lp I CFR 172a5LS VOLUME 118) PER CAPITA I N f A K € tl4G/ DA7) . 2036. 0.02036 NATURAL OCCURRENCE IFC FGOU [S) BIOLOGICAL O A T A R A T MAL LO1 5 0 ) 2­ 25­ 3.38 GfUG REF ER€ NCE GAUNT 70 ,' (continued on next page) 93 i .. I 4 .." ""_ "i .. . . . " .­ . ­ .. . . USE L€ VEL IPPMJ : MAX 7.00 TO 12.00 USUAL 2.67 TO 6.00 6IOLOGICAl O A I A NGN E .. 95 fiEfERENC€­ NOM . .. 1. Food Flavoring and Compounds of Related Structure. 1. Acute Oral 2. Acute Oral Toxicity and Repellency of 933 Chemicals to House and Toxicity. Deer Mice. Factors Affecting Absorption from Hamster Cheek Pouch. 4. The Acute Oral Toxicity, Repellency, and Hazard Potential of 998 Chemicals to One or More Species of Wild and Domestic Birds. 5. ComparisonofFish Toxicity Screening Data and QSAR Predictions for 48 Aniline Derivatives. , 3. Studies of Drug Absorption from Oral Cavity: Physico­ chemical ' I I Research Section Food Flavourings and Compounds of Related Structure I. Acute Oral Toxicity p. M. J, ENNER, E. C. HAGAN, JEAN M. TAYLOR, E. L. COOK and 0. G. FITZHUGH Di,. tsion o/ Toxicological Evaluation$ Food and Drug Administration, Vnifed States kpartment of Health. Education, and Wel/ m, Washington 25, D. C., U. S. A. (Received 11 MUF 1964) Al& act" Oral dosages of 107 synthetic and naturai flavourings and structurally­ related corn ~~u n d s were administered by intubation to the mouse, rat or guinea­ pig. A n i d were ob­ served usually lor 2 weeks during which time the development of toxic si­ was fdlowed and tim of death r~~ rded. The acute oral LD,, of each compound was determined. MRODUCTlON Substances w d as food flavourings have rcceived little attention from the toxicological vjewoint. Becaw of their extensive ux as food additives, the Food and Drug Administra­ tion has been investigating their toxicity. The initial step in our toxicity studies was the determination of the acute oral effects. This paper presents data on acute toxicity for a large number of flavouring matters. Similar data are reported for additionai compounds, not ncccssarily flavourings, but included as a means of correlating structure with toxicity. These relationships b v e been discussed by Taylor, Jenner & Jones (1964) and Hagan, JeMer, Jones & Fitzhugh­ Toxicology: Long, Brouwer & Webb­ Pathology (1964). Flavour additives include compounds with a wide variety of chemical structures, and mixtures of variable composition derived from plants and other natural sources. Some of the substances are synthetic, others are isolares or extracts of natural products. Since the purpose of the* studies was to evaluate the toxicity of thex materials in relation to their UK as food additives, a commercially available material was used. No attempt was made to secure chemically pure compounds. METHODS Groups of 10 young adult Osborne­ Mendel rats evenly divided by sa were fasted for approximately 18 hr prior to treatment. Groups of guinea­ pigs consisting of both males and females were fasted for the same period. Mice were treated on full stomachs. Animals had access to water at all times, and the food was replaced in cages as soon as animals reccivcd their respective doses. A I 1 doses were given by intubation. All animals were maintained under clox observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain The usual observation period was 2 weeks; in a few cases, where no acute toxic signs were­ seen, the animals were observed for only one i* eek. LD, 's were computed by the method of titchfield & Wilcoxon (1949). A 327 343 Condiments et Complexes de Strucfurc I'oisine. I. Tosiciti Ai@ par \'& Buccale ~Cwni­ On adrninistra par intubation des d m de complexes faits & 107 condimenu syn­­ thetiqua et naturels, de structure chimique voisinc. i da souris, des rats et des cobayes. On obxrva habituellemnt ks anirnaua pendanI2 scmaines, durant lerquelks on suivit k divelog pcment de sigtus toxiqua et on nota la date de la mort. Pour chaquc compkAe on dClcrmina la dose ordelimite au­ deli de laquellc commence I'intoxication aigul!. Lebensmittelg~ hmac~ zusatze und Verbindungen verwdter Struckt\ mn 1. Akute Onltoxititat Zu~ tnrnenf~~ smng" 107 synthetirhen un narorliche Gtk­ hmackuudtte und nrukturvcr­ wandte Vcrbingdungm wvrden durch. Intubalion an M a u ~, Ratten und hlecrschweinchen vcraixeicht. Die Tiere wurdcn gewohnlich 2 Wochen Ian8 unttr Beobachtung ­Iten. uahrend wekher Zcit die Entwicklung toxixhcr Sxmptome vcrfolgl und die &it da Tod­ exintritts rcpistrien wurde. Die alrute orale rn~ ltlcre Wliche Dosir j d e r Verbindung wurdc feslgcs~ ellt. B J x .., < cy I 326 FORTHCOMING PAPERS, CORRICESDA I the same­ an initial description of the substance is followed by txamplcsof its likely use, the toxic dose andlor maximum allowable concentration (i f known) and likely pathological effects. Descriptionsof clinical findings in acute­ andchronicpoisoning arc related to laboratory and X­ ray examination, and an­ outline given of emergency treatment and prop nosis. The author has not hesitated t o use trade names uherc the composition of the formula. tion is no* obvious. This has added to the usefulness of the book, which is concise and cleal, yet sufficiently detailed possibly lo instruct those who may considerthcmselvcswell ac­ quainted with industrial poisons. FORTHCOMNG PAPERS I t is hoped to publish the following papers in the nextissue of Food und Co.~ ntetir. t ToxicologJJ: Food flavourings and compounds of related structure. I. Acute oral toxicity. By P. M. Jenner, E. C. Hapn, Jean hl. Taylor, E. L. Cook and 0. G. Fiuhugh. The effect on rats of longyterm exposure of Guinea Green B and Benzyl Violet 4B. By W. A. Manncll, H. C. Grice and lsabelle Dupuis. Recherchcs dephysiologie cellulairc sur la losicitti de I'alcool tthlique. Par R. Low, et "1 : I'olunte I (I963) . ­ ­I G. Griffaton. Etudes sur I'activiti azoreductasique des surnageants d'hornogenat de foie de rat. Par ph. Manchon, S. Gradnauer et R. Low. CORRIGENDA x , p. 229, linc 13: for E 214 p­ Hydrox_ vberuc? ic acid, and its sodium salt IMJ E 214 Lth! l 4 ester oip­ hydroxybenzoic acid and its sodium salt. p. 57, lines 28­ 35 inclusive u. hich constitute 'Srction( 4) Resinous and Pol> neric coaliny. ' ,' I­ were included in error and should be deleled. 1 i Volunte 2 (1964) . . ­, ' I ­1 ...... .. ,. ::. L ........... ..... ­ .. , ~bmd. Fiveindividualbioassayrepeliency or toxicity variables were estimated or determined for deer mice (Peromyscus mnniculafus) and house mice (MUS musculus) under laboratory conditions. ALDS (Approximate Lethal Doses) or LD" s of 2~ chcfnids to deer mice are presented, as are f& nduction (FR) values (3day feeding test as a 2 .~ treatment rate) for whitewheatseeds (Tri­ ticum aesfivum) for 6% chemicals and Douglas fu x& (Pseudofsuga menziesii) for 81 chemicals. A GmilN repellency evaluation (REP) using a Sday test with white wheat seeds at a 2.0%~ treatment rate was conducted with house mice and the results For 347 chemicals are presented. These toxicity and re­ pcltency data should be useful to those desiring to predict the potential for acme toxicity in wild mam­ mals following exposure to a wide variety of chem­ M S . A calculation of the daily chemical dose ingested in mgkglday during the wheat test on deer mice and its resultant effects on mortality are also presented for most of the 696 chemicals. This calculated value, when used along with the ALD or LD5,. should permit a rough estimate o€ the potential sub­ acute toxicity of any tested chemical, on wild m a ­ mals for which both types of data are availablt. A series of publications summarizing the results of opproximateiy 25 years of chemical research con­ ducted by the Denver Wildlife Research Center (UWRC), on wild or domestic birds and mammals has been initiated. The first publication presented wild avian toxicity or repellency results for 998 chemicals (Schafer et 01. 1983). This paper will present similar data for 933 chemicals tested on wild deer mice and white (house) mice. Our purpose is to make available these generally unpublished test results so that they tan be referenced or usedby the various public, private, and governmental groups that may require this information. Methods ' h e chemicals included in & tests were technical of analucii. 1 grade pesticides and other commercially available or cxperi­ mental chemicals. Tbcy were purchased from various commer­ cial sources or conmbutcd by cooperating chemical cmnpanics. For presentation purpoxs. they have k e n prrangcd by Chemical Abstracts Registry Number (CASRN). and PIC idenlified by an accepted trade. coined. product or other chemical name that is penedl? ncrr included in thc 8th or Rh Collcctiw In&\ of the Chemical Absuacts Senice. ' Wild­ trapped house and deer mice or domestically bred house mice were used in dl test procedures which are dcscnid in deldil by Kvem (1954) and Kverno. a 01. (1965). Five bioassay tests were conducted. resulting in six basic data sets as f0llow. t: .. Repellency k c rcpeileacy tests were conducted, two on dew mice and one on house mice. ?bc initid test used five individually caged deer mice. Each was offered 2S white wheat seeds treated with 2.0% (wtlwt) oftbe candidate chemical daily for 3 days. followed by 4 days d observation for gross subacute effects. An alternate less preferred food (laboratory d e n t pellets) and aater were . Because of the length and complexity of Chemical Abstracts nomenclature. tbe names used to identify chemicals in Table 1 were extracted from several sources. Primary consideration uras given to the common name, but shorkned chemical names. code numbers, or registered trademarks were also used but may not be specifically identified. .. ............. ................ ...... ........... .. .. .... .. .. ......... 2.. ; t 12 Alloxan lremorine U re t h u K Bay 37341 DL­ Penicillamine pilocupint hydrochloride 3,& Diaminopyridim Baycr 37342 Fcnthion Tetraethylammonium chloride Tributyltin oxide Tiiutyltin acetote Dicthylstifkstcrd . ' Bis( phcnoxyarsiny1) oxide 2­ Hydroxyquinoline 2­ Bentoxm\ d Strychnine sulfate Dimethoate CNilroknzoic acid Sodium fluoroaceute c­ 1 Phcnylacetylurea 3­ Mcthylphcnyluru I ­Phenylurca Physostigmine sulfate Tctracyciinc bydrochloride ~Aminosllicylic acid Bcnzoic acid Phena+ ine hydrochloride CydoHexamide CM~ zhylkntenesuKoaMlidc Endrin MestTIlrd N,~­ Dipkn~­ l. Cphcnylcnediamine p­ Nitrophcnylazoresorcind Ethyl mcrcrptra Isopropyl mercaptan ~~ H­ BuC~ I AnOXanti8 Auytripbenyltin Triphenyhiu hydroxide Diiurylcin dilaunte Dimcthyhydanloin Bis( tripheay1tin) sulfide . hiutyltia maleate Menaura Thiosemicarbazide 2­ MelhacryIic acid Dapsone Tetramethylenedisdfotetmmine coumaphoz I­ Ethyb­ k 3,5­ Dunelhylpynzole Dichlow~ thyl b i,.+. c ­. :.> x N­ Bu! y~~ su~ o~~ a. sulfa" anijidine ".,­>, i,.":. p ., i. :. TigIic acid +:_. Musk xyld Warfarin /' ­ ­1"­ 50715 +1m 51730 +70.0 517% + 1150 52608 +S I . 52664 + 1230 54711 ­ 54966 + 1125 55378 t 347 s5389 461.5. S6348 + I250 .% 359 +Mo 56W 437.5 56531 +I 4 6 56572 ­ 58366 + 50.0 59314 ­ 59494 ­ 60413 ­ 60515 +375 61289 ­ 62748 ­263 63252 +6Qo 63989 +I 2 5 0 63990 + 1225 6410% +I238 64471 ­ 654% +1113 65850 + 1250 66057 +336 "9 ­125 67516 ­ 70553 ­. 72004 +a 72208 ­100 72333 +950 14317 ­ 74395 ­ 75081 +I238 62231 ­ 647s. +925 75332 + 1238 75661 +I 2 5 0 76244 + 1013 76631 ­68.8 76879 + 75.0 77587 +427 77714 i l 2 5 0 77805 +663 78046 +250 78579 +613 791% +317 79414 ­1238. 8oO80­ 80126 ­113 80228 +121 80591 +flu) 8 i m + 1213 81812 +1233 .. . . . . . , , '.. .. . . 0.00 8.00 1.60 94.4 20.7 ­ 10.0 72.3­ 83.0 95.0­ 97.0 84.0 97 .O 39.5­ 98.8 w. 0­ 98.0 0.00 ­ ­ ­ ­ 70.0 ­ ­ 79.0 s2. o 0.00 2.00. 1.00 . ­ 38.0 11.0 0.00 73.1 90.0 ­ ­ 71 ­0 92.0 24 ­0 ­. ­ I .00 I .oo 0.00 19.0 89. q1.0095) 94.0­ w. 0 0 .9 417.0­ 14.0. 80.0 51.1 71.7­ 88.0 0.00 1­ 00 ­ 91 ­0 1.00. 8.00 3.00 t 3 3 . . ... : ' ­­ ' .. .. . . .. ­. . ..... , .. 82439 + 1 125 82431 + 1225 a3012 ­ 83078 .+ SO0 a3u1 +u 3 M662 ­ am + 1238 855% ­ s55983 + 1125 86533 +850 174'18 +313 87514 + 1243 87M1 ­ 1240 87887 +I 1 2 5 88Mo +425 88120 +lo90 88142 ?1225 60299 + 1038 89009 +I163 89021 +I 1 3 8 892s +I 2 5 0 893% + 1150 89394 +12M 89623 ­ @I690 isso 90017 +I 2 3 0 91021 +8U 91634 +I176 92524 +450 92535 + I225 9jm ­ 92842 ­ 93049 +825 93107 +925 93185 + 1213 93469 " 93754 +463 94091­ 94188 ­ 94520 +l l S 9 4 8 6 0 .­ 95034 +975 95647 +900 95692 +315 95716 ­ 95761 + 75.0 957w +. 843 9588s ­ 96128 +I240 96242 +625 , 96311 +I250 964s7 +I 2 5 0 96480 +I245 96504 +350 96537 +20.0 96968 +1175' 96991 +I250 925991 ­ 10.0 2.00 ­ 56.0 "5­ 98.4 ­ I ­00 ­ 10.0 32.0 75­ 0 0.5" 10.6 0. m­ 2.40 10.0 9.0 12.8 2.00 17.0­ 50.0 7.00 9.00 0.00 8. W 0.00 ­ 56.0 34 .O 64.0 . , 0.00 5.87. 2.00 ­ ­ ­ u. 0 , . . 26.0 3.00 ­ 63­ 0 ­. ­ 5.00 ­ 22­ 0 28.0 70.0 94 ­0 31 ­0 ­ ­ 0.800 0.00 0­ 00 0.330 72.0 38.4 50.0 . . 6.00 0.00 ­ . Yellow sulfon chloride Genite +Chloro­ 2, Cdimethoxrrnilinc 2­ Amino­ S­ azotolume Anantoin &nzenesulfonyl, chloride 4­ Bromobenzenesulfonyl chloride &Chlorobenzenesulfonyl cbbridc >Nitroaniline Citrarinic acid SNitro­ 2­ mclhylanili~ ZCNitro­ 2~ methoxyaniline . . 1.3­ Dinitrobenzene Methylparaben Ethyl 4­ nitrobtntoate Moslenc 4'­ Aminoacetopheno~ &Nitroaniline Isocinchomcronic acid KyanopyridiM Benzaldehyde 3€ yanopyridiw 3­ F+ yridylcubinol 2­ Cyanopyridine Hexamethylenetetramine h c n e +hind'­ nitrodiphenyI sulfide 2­ Ethylpyridin1 ~Isopropylaminophenyllmine 4­ Bcnzencazodiphcnylamine 4.4'­ Diaminophen). lmethanc U'­ Diaminqphen) l ethc: :­ Benzylpyridine h'. N" Di­ srr­ butyl­ p­ phca)­ fcnediunine Phinyluretbam 2.5­ Dimethox) aniline kra­ Nitrostyrene ­ Hydroquinone monobenzyl ether Azobenzcne Benzyl succinate DiethyE3ox~ utarate lj­ Diethylthioulta F'mpyl butyrpte em01 CChIoroaniline 4Methplaniline l­ Methyl4piperidinol CChlorobenzenelhiol . ' Acrolein l­ propyl mercaptan Tetraethylpymphosphate >Mereaptopropionic acid Pyrazoxon 3­ Methylthiophenol 2.4­ Dimethylpyridine 2.6Dimethylpyridine Thiophenol w ;none . . .. Registry Numhcr 14, (CAS) (mg'kddayl 97M5 +338 97165 +1152 97507 +m 97563 + 1250 975% + 1038 98099 +m 98588 +888 98602 +I113 99092+ 37s 99116 + 1200 99358 +788 : 99592 + IOU) 9% u)­ 99763 +I 2 5 0 99774 +IW 99854 +I238 99923 ­82s 100016 +1250 100265 +I 2 5 0 .. 1 w 1 +I 2 3 8 100527 + 1250 I00549 +I225 1o05u) +I250 100709 + 1188 io0710 + I175 100970 +I 2 5 0 101053 + I 175 101597 ­ 101724 ­ 141757 + 838 101779 .­ 1100 IO1804 ­ 10'5 101816 ­ 1W 101w2 ­ 101995 + 1138 102567 ­ +638 102965 +I23 103162 .­ 103333 +SO io3435 ­ lwm L 105555 ­213 105668 ­ 106445 + 1238 106478 ­ 106514 + 10% 106525 + 1138 106547 +lo25 107028 +1m 107039 + 1250 107493 ­ 113 107960 +950 108349 ­12.5 108407 +I 2 3 108474 + 1238 108485 +1250 108& +I238 105490 . + IO3 Deer m o u e ­ ­ 100 40.0 ­ 100 30.0 70.0 0.00­ 20.0 1 ­ i 2o. o. Q 40.0 40.0 \ 10.0 ­ ­ .......... .. :., ......... .. ........ ....... .....­... . _:_. r... i. 109002 +1225 109046 +I250 109057 .+ 1250 109091 +I240 109433 .­ 109466 +B25 109579 +I00 109795 + I163 109808 +I 5 0 lM20 +I 1 2 5 110203. + 1238 1 10383 + i I 5 0 1I" +lo88 110601 ­1225 110667 +I t s 0 110% 61 + 1250 110872 +12M 111864 ­ 111886 +I 2 3 8 112129+ 950 112312 +IO50 112527 + 1238 IIUU) +138 112889 +1206 113928 ­ 114261+ 760 115695 + 1 0 0 115786 + 150 115902 ­50.0 1159913 ­50.0 116063 ­55.2 11G38 ­625 I .i i 5 2 ­ 1250 117782 +625 118741 +I 2 5 0 118752 +. W. i 1 ~2 3 + 1237 118934 +I227 119324 ­ 319380 +I 8 8 119539 +lo25 11975s ­ 119813 ­ 120354 f 1188 120887 ­ 120934 +ll75 121508 +I 2 2 5 121664 ­ 121711 '+ I237 121755 +490 122145 +I25 1221% +463 122667 + 1213 122883 ­ 123693 + 913 123751 . +914 120729 + 1001 124129 ­ 2 .00 0.00 0.00 0.00 ­ 34.0 92.0 7.00 88.0 10.0 I .00 1.00 13.0 2.00 0.00 0.00 0.00 I .00 ­ 24 .O 16.0 1 .00 9. w 3.47 ­ 29.8­ 47.9 92.0 88.0 96.0 96.0 S2.0­ 95.2 cn. 0 0.00 50.0 0.00 ?LO . 1.07 ... 1.87 85.0 18.0 ­ ­ ­, 5.00 19.5­ 46.0 6.00 . 240 1.07 ­ ­ 60.8 90.0­ 95­ 0 63.0 3.00 ­ 27.0 26.9 ­ 116 Name Hydroxyurea Endothd 1,4­ Naphthquinone Quinine hydrochloride 2­ Chioraonthraquinone CBenrcne~ I­ naphlhylamim I­ Naphthyiacetonitriiee Captan Folpct . 2­ Methoxy­ 4­ nitro­~ methy~ iline phenyl­ 2naphthylamine CHcxylresorcind 2. Aminobcnrolhia~ le 2­ Methylthiopknd . 2­ Aminobcntcnethid 2, CDiaminophenol dihydrochloride Thiram zinun Bis( 4aminophenyi) sulfide . Maraluride cchlorobcnryl cyanide DeXOa Dicrotophos 2.6Diaminopyridine 2­ Hydroxypyridine Nabam Lakc 8cid Decylammonium chloride Decyl mercaptan Chlordecone Musk tibctene p­ Saphlholbcnzein , Tribuf yltin chloride 2­ Mercaptobenzoic acid 8­ Hydroxyquinoline N. N" Diphenykthylenedirmine e Methyl anthranilate 2­~ er~ pt~ bcnZothhZok o c l a m e t h y l p y r o ~p ~o ~ Zinc mercaploknzothiatdt Methscopolamiae bromide 2­ AminottbaneW hydrochloride ltobenzan Phosphamidon Thiodemeton Zytron Acreoline hydrobromide Lead acetate chloral hydrate 2­ Chlorovinyl diethyl phosphale Mexacarbatc S­ ChlorosaIicylic acid . Tirichloronate Chminonicotinamide 3.5­ Disopropyl phenyl carbamate. Tnbieth~~ y~ bOsphine tuKde . 2,4DiN? rothymd N­ 2404 I I7 333299 + 22.0 333437 ­ 125 367215 + I038 379522 + 163 439145 +388 452584 +850 452777 + 1 175 462088 +m o 462942 +lo88 470906 +806 480682 ­ 492808 + 1050 495481 +700 496468 + 1100 496142 +725 499810 +I 2 3 8 so0221 +I238 5001520 +913 5001815 + 1225 502367 +613 504245 + 143 504290 +1w 504530 ­ 504881 +613 513440 +I 2 3 8 513531 + 1175 519879 ­ 521744 + 1238 524425 ' +138 '. 534134 t 675 535875 * 1% 536374 ­ 1250 536754 .+ I238 537917 ­ 538432 ­ 538589 ­ 540314 + 1250 5406% +I 3 0 541311 + I213 544478 +e5 552943 +1w 5S3173 ­ 555215 ­ 5571 19 238 563257 ­75.0 574458 ­ 575360 ­ . 581975 ­ 583S84 * 130 583755 + 1900 S86981 + 1250 588534 ­ 589106 +338 591082 +363 591220 i92S 592314 + 1188 583697 ­ #I .o 90.0 17.0 87.0 69.0 32.0 6.00 0.00 13.0 35.5 16.0 u. 0 12.0 42.0 ­ 1.00 1 .00 27.0 2.00 51.0­ 57.0 87.0. 0.00 51.0 ­ 1.00 6.00 1 .OO ­ 41 .O 46.0 0.00 0. M I .oo ­. ­ ­ 0.00 0.00 3.00 95.0 0.00 ­ ­ a1 .o 9.0­ 95.0 ­ ­ ­ 0.00 20.0 0.00 73.0 71.0­ 99.0 29­ 0 ­ ­ 5.00 .,.. ' 1 I8 1 Butyl carbrmate Octadccane Tetnmeihyltin Tctnphcnyllead Tetnphenyltin Dibutyl sulfone I­ Methylurei Bjs( 3­ aminophcnyl) sulfone fi­ km­ naphthd Riphenylarsine ~phenybismuth Diphenylurethane Iv, hl­ Diphcnylformamik gNitroquinolim CMethyl­ 2quinolone 2,& Dibrom& aminopheno1 mmethyl Cnitrophthalrte Methyl 2thloroknzoaw &nulacetophenow dibromide 2­ Nitrobenzoniuik 6­ Chloroquinolim 2­ Naphthoylacctonitriilc 2­ Naphthyl Ulicyhte 2Spnbacetopheno~ Benroylurrr 2­ Methylphenyturu 2­ Pyrrolidone Methyt 3­ iodobenzoate 4Xitrodiphenyl ether Glycerol I.?­ diphcn> l ether CEthoxyphenol 2chloroethyl phenyl ether CBromdibenZonitrik CChlorobenzonitni 1.3Dielbylurcr Methyl derate 2,5­ h% romopy1idi1~ I­ Ethyluiu 3$­ Dibromop). ridiae 2.6; Dibromopyridiae : IBromopyridine 3­ Methylpiperidiae CMethylpipcridiae CHydroxypyridinc 1­ Mcthylpiperdinc n­ Ropyluru Propyl carbamate Pentyl cyanide Heptad oxime , Doaecyl cyvride Tetramethylurrp ,Acetylsalicylaldehyde diacetait DL­ 2­ Methylb~ tyriC acid 1­ MethylhydanlOia Ethyl 2­ furana~ w) lte 3­ chloropyndiinc k?>" 1. '. \ _' . e­. r, 2,3. C? etrahydmquinoliac p;; 2 .; [ 1" 4( 3& 3m3­&~ itroanilinr­ . . , \ ­"­ I­­ i."­.> >>. _q" i .. _j . . *..L :y ..:s ­ SZ&.*. ­ i . . . . . . . , _, .. , . .. '..,. . , ~­.", I ,.." . . . ,. 59923% + 1213 593453 + 1229 594274 ­ 595891 ­ 595904 + 1075 598049 + 1013 598505 +I230 599611 ­ 6ooon + 1238 ,602095 +I 8 8 603327 ­ 603338 ­ 60352 I i 1 138 , 607001 ­ 607352 ­ 607469 ­ 609212 i988 610220 ­ 61096% ­ 611916 ­ 612218 +888 613570 . + 1238 613785 + 1250 614164 +I225 614222 +763 616046 +I138 61645s +I250 6 1 z n ­+ 1238 6 w n ­ +IW 618917 +llSO 620882 ­ 622W ­ 622628 ­ 622866 +I213 623007 +1213 623030 + 1238 63767 + I113 624282 +I238 625525 + I138 63923 + 1188 616051 +625 626551 + 1225 626562 +938 626S84 + 1238 626608 +I238 e6642 +I 2 5 0 626675 +lU8 627065 + 1 138 627123 + 1225 628739 ­ 629312 +122S 6 W 7 ­ 632224 + 1125 634208 +12S 635223 +725 635461 ­ 623201 ­ 624248 ­ 3.00 I .67 +­ 14.0 19.0 0.00 1 .00 ­ 85 ­0 ­ ­ 9.00 ­ ­ ­ 21.0 ­ ­ ­ 29.0 I ­al 1.00 0.00 2.00 0.00 9.00 0.00 8 .00 39.0 ­ ­ ­. 3.00 %. 00 1.00 ­ 11.0 ­ I .oo 9.00 5.00 2.00 1 .00 1­ 00 0.00 J .OO 9.00 2.00 2.00 10.0 0.00 42.0 50.0 25.0 ­ ­ ­ 7 .." '1 Dimethoxon rruns­ l. 2­ 8is( propylrulfonylKthcne Rbuklt Vancidt OD . Butyltin trichloride Picdind bXcthyl­ 3­ pyridinol +Acetylpyridine C( Dimcthy1amino) pyrididinc 24cctylpyridinc CAcetamidoknzcncthid 2,6h'acetylpyridinc Diphenyltin chloride Triphenyllcad chloride bye1 56301 Tripbenynead acewe Copper &M~ C l. CDimersaptobut9ne €, bDimercaptohcxane I& Octanedithol 1.1& Dimercaptodeune CMcnaptoaniline 2.6. Dichloroknronitrile Hydroquinone diacctlte Bis( 4nitrophenyl) 5uUidc Zinc phosphide Arsenic trioxide Niclosamide I$­ hinzylthioun Bayu 31757 (Cyanoacetyl) una Sonyl mercaptan Elhyl oxanilate k% utyltin chloride TeWutyltin Ethylcyclohcxanc carbamate K­ Dodccylmorpholiac Cyclokxyl mercapun Cycbbcxanonc stmi# amt 2­ Amine3­ methylpyridiw %MethyI­ 2­ aminop> Tidii McthylCniuocinnamaIe Xhioropropanesuliooyl chloride n­ Heptyl n w c a p ~ Methyl­ rn­ nitrocinnamate 44iydroxyazobenzenc Ethyl fenthion 4.4'­( 1,2­ ElhancdiyI) bismorphdiac Triphenylgermanium sulfide Thiobeqyltriphcnyl lead Bis( triphcnyUcad1 sulfide Bayer 6103s N­ Cydohexylanilinc 6Amino­ Z­ me~ hyIpyridine CChlorobenzylidenemaImoalononiVile 2­ Cyanoaniline N­ l~ p~ pykyclohexykminc 2 ~M ~t h y l ­2 ­b ~t a t h ~l .... 1113026 ­75.0 1113110 ­ 1114712 + 1225 I l l W . +563 1118463 + 1240 ~ 11216M +t u 0 1121781 + 1238 1122549 + I O 0 0 1122583 + 350 1122629 + 1250 1126814 ­ + 1050 1129302 + 1088 1135995 + 188 1153066 +413 1156521 + 25.0 1162067 ­ 1184641 + 1200 1191088 + 1175 1191431 + 1225 1191624 +988 1191679 ­675 1193028 +463 11946s6 +m I195422 + 1163 1205910 ­ 1223310:. ­ 1314847 ­ 1327533 i 1250 142005% +900 1424142 + 1213 1423710 + 1227 1448982 +I200 1455216 + 1150 1457858 ­ 1461229 is88 34612S2 +913 1541191 +925 1541817 + 1063 ­ 156% 93 + lo00 158% 13 ­ 16034.03 +1238 1603414 + I175 1608362 +1m 163383 . +238 1639091 + 1113 1WRl ­ 1679090 +1200 1689823 ­ 1716092 +87S 1723940 + I O 0 0 1802773 ­ 1802864 ­ 1802886 ­ 1804586 ­ 175 1821369 +a8 1824813 +lo50 1867385 + 1238 1885296 + 1238 .... 94 .O ­ 2.00 0.80 0.00 1 .00 20.0 72.0 0.00 16.0 13.0 85.0 67 .O 98.0 55.0 ­ 4.00 6.00 2.00 21 .o .. 46.0 63.0 36.0 7.00 ­ ­ 0.00 3.00 1.86 4.00 8.00 28.0 ­ 33.0­ 95.0 27.0­ 33.0 26.0 ls. o­ 19.0 20.0 ­ 1 .00 6. M) 0.00 41 .o 11.0 4.00 ­ 93 .O 20.0 ­ ­ ­ 866 29.0 16.0 1 .a0 1 .OO ..... ", ...... ..... ..................... ­ 100 70.0 ­ ­ 10.0 10.0­ 20.0 ­ ­ ­ 70.0 100 100 100 0.00 20.0 0.00 ­ 10.0 40.0 100 " m. 0 0.00 100 &yer 39197 &ycr 3 0 9 1 I Chloroneb i. 6Hexanedithiol diacctafc Trimcthaurb 2­ Chlorobenzylidenemalononitril~ Bayer 299S2 SD 1092 2~ 2­ AminocthylJpyridine Enticidc Diityltin bisf2trhylhexolW Bcnrylidcne methyl Tetramclhylthioure? Hcxaphcnyldigermane pBromoknzalmalononitnk AnisaImalononitrilc jNiuobenrylidencmalonom~ e Byer 47416 Ehycr 4718s ­ eMe1boxybcnzalmdononivik NCyclohexylaminocthand 10Chlorophenoxyusinc Rntachlarophenyl vichloroacelate Octadecyl mercaptan Bayer 29491 Dimethyltetrachloroclhyl &yer 42#) 3 1.3­ Diisopropylthioura 2­ Ucth~ tmer: aproanilinc Triqslohtrt ltin chlcridc Trinitrobemcnc­ aniline compkx Hcxaphenyldilad Triphcnylmcthyllead ­ Phenacridan chloride Tninzyltin chloride . 1QPyIidyl" 2­ nitrop~ pclK Bayer. 30468 . Bayer 3037 Baycr 23248 Bayer 22681 AmfJ GC 6506 liipropylrin acetate Hercules 7644 6­ MethyE3pyidonc R 55 Elayer 307% SI) 4239 SD 2801 Triamyltin chloride Ethyl isodehydroactt~ tr Methyl 3­ bromopropiona1e 1.9­ Nonanedithiol I­ Baycr 37343 phosphorodithicut~ Bayer a738 Ihiohydantoin . 1 ~2 ­M c ~x ~~h c n ~l ~~­N t ~~e n c 2668920 + 1104 2fA7494 + 25.0 2675776 + IO00 2678297 + 1180 2686999 +213 ' 2698411 + 175 2703131 + 50.0 2703619 + 380 2706561 + 1213 2728021 +I 2 5 0 2781 101 + 62.5 2782709 + 375 2782914 + 1050 2799953 ­ 138 2 8 1 6 3 9 9 ­ 2826246 + 1200 2826268 + 1 1 8 8 2826326 + 1075 2830866 ­62.5 2830877 +m 2834ld8 ­ 2842388 +I 1 2 5 286570s + 100 2879609 +I156 2885009. . +a 8 2951179 t 12.5 2939971 + 138 298% 58 + 513 m 1 7 6 +23a ,% '? 2? ­ ?09132 ­ 3101199 . +X 0 3121014 ­ ' 3124285 ­ 3131086 +750 315141s ­ ­ 3156534 +86.7 3186121 ­62.5 3186149 ­75.0 3212188 +268 3212199 +U. O 324490( +690 3254635 +9.0 3267785 + 62.5 3279467 ­ 3279763 + 1575 3301970 +338 3309715 ­25.0 3309771 . +743 3309839 +11a 3316243 . +30.0 3341674 ­ 3385340 + 1233 3395913 ­ 34892sl +755 3506283 +a75 11.7­%. 0 ­ 98 .O 20.0 5.60 ­ 80.0­ 83.0 ­ 86.0 ­ 96.0 ­ 69.6 ­ ­ 3.00 0.00 ­ ­ 95.0 70.0 16.0 89.0 ­ ­ ­ ­ ­ ­ 4.00 6.00 14.0 ­ 95.0 77.0 10.0 92.0 ­ 7.47 29.0 99.0 ­ 89.0 7.00 59.0 4.00 81 .o ­ ­ ­ ­ ­ ­ ­ .­ ­ ­ ­ ­ 94.0 1 .a ­ ­ ­ ­ 40.0 93.1 34.8 95.0 . . ­ 94.0 ­ 98.0 ­ 14.8 ­ 96.0 ­ 95 .o ­ ­ ­ ­ ­ n. o ­ ­ ­ 6.00 73 .O I .00 %. 0( 1. WC) ­ 46.6 ­ 97.6 42.5 ­ 5.00 ­ ­ ­ 1.33 ­ ­ 38.0 93.0 ­­ ­ ­ ­ I I23 . . . . . . . . .' . ..", ­ ,. . .­ 35 I3926 + 588 3542367 ­ 35442%. + I 1 8 8 3544250 +9M 3554743 + 1250 3568512 + 25.0 3568567 ­6.25 3 5 w 9 ­ 3600122 +7l3 3600133 ­ 3600144 ­ 3686917 i 1 2 S 36871% ­ 369 1358 .­ 739 3692908 ­ 3695770 + 1188 3731531 + 1213 3733844 +t83 3734336 + I u s 3734676 + 1088 3736810 + 3SO 3765659 ­ 3766812 + 1175 3790236 +850 3846499 + 1238 373 1520 + ION 3860820 ­ 387& 53 ­ 393 1055 + 725 3958198 ­ 4104147 ­71.1 ' 1 W 9 +62.5 4158376 ­ 4164390 +I225 4253229 + 3 13 4301502 ­200 4342363 +37J 4412093 + 1169 4432U2 ­ 4543452 +I 1 8 8 4631634 ­ 4637461 ­ 4638497 +lo63 4580788 +1m 4723244 ­ 4731s37 ­ 4746092 ­ 4808304 +I 1 3 ­soo6fs +12M 5034582 +763 SO35585 ­ SO35676 ­ 5153286 ­ 5219614 +700 s290620 ­ s299su i300 . .... .... _._ .. 1070 1.00­ 3.75 53.0 ­ 5 .0 0 0.00 99.01 I .as, 24 .O 98.0 ­ 43.0 ­ ­ 90.0 ­ 40.9 ­ 5.00 17.0 3.0 37.4 2.00 . 13.0 72 .o 6.00 1 .00 ­ 32.0 ­. ­ 42.0 '6 @­E 0 95 .o ­ ­ 2.00 75 .O 84.0 97.0 6.50 5.00 . ­ ­ ­ 1x0 0.00 ­ ­ 91 ­0 0.00 39.0 . ­ 100 44.0 76.0 ­ ­ .. ­. . .. ,. : ... . ... " __ . . .. ." . . . , . . . . . . . . f 2 4 Regis~ q (CAS) (mgkkglday) Number LD, S332069 + 1225 S332SU + 1138 53SI519 ­ S37( 061 + I S 0 S396714 ­ 5401874 + 738 5414211 + I188 3424191 + 975 5439391 + 1013 54SIW7 ­ . 5470188 +92S S478347 ­ 5529431 + 1250 ssms1 ­ 5683330 +I 2 2 5 S821 IO + 163 5823176 +444 S823212 + I 1 9 4 %232% + 1143 58u901 ­ 5826959 +939 5827565 ­ 5835950 +us 5836668 + 1226 5840959 +263 5842002 +438 5841483 + 12.5 . 5847UI ­ 5041S52 +227 , 5863729 ­ S90246S +75.0 5903082 ­3 0 0 59" 9fj$ ­ ]W 5978347 .+ 1 I25 6046931 + IO63 6258668, + 1213 NUTIC 4­ Bromobutyronitrik Undecyl mercaptan I­ Mercaptd. 5­ dimcthylthiz~ oI~ 4, CDi­ rrrr­ burylreiordnol .Ethyl mi­ nitrocinnamate . 4.~ DimethyI­ 2­ pyridiruminc 5­ Bromovaleronitrile 3­ Bcnroylpyridine Cinnamylidcnemalononitrile n­ Nonyl chloroacetate 2­ Chioro­ 3­ nitropyridine 24Benzylamino) ethamlhid Sdicylsaficylic acid BromochlorenoM 2­( h'methylamino) pyridine Bayer 16948 Barer 18341 Baycr 1893s Bayu 18613 vancide M Bays 19994 kcnlauryltin Bayer 20143 2J­ Dibromc~ I­ melhor). propane R 3422 2­( Butylaminokthanethioi Tniutyltin hydroxyacetlte Dibutyltin dibcnroW Diiutyltin stearate Tniufyltin propionate Bayu 20172 Bayer 248112 "Qclohcx! irminole: tdne! hiol 2~ entylaminokthanelhiol Copper ace! a! e monobydnte 443lorobcnzyl mercaptan Dimethy1nitrooxoprop) ran carboxylic acid ester I) i­&" bulamiae bydrochloridt Thiodipropionhydrazide n­ Hexyl sulfuk t­ Chlore3­ pyridinamine 2 ~p r 0 b c ~0 y l ~~7 i d i n c 4­ Chlo~ 2,5dimcthoxja11ilioe Sodium biWonolslc Auyloxycarb Diiutyldiphcnyhin Y­ Chloro­ S­ nitrosalicylanilide 2,4.~ TriisopropyIbcnzcnesrllfon~~ 1,3­ Bis( carboxypcntylrhiourca 2­ Anilinopyridine CAmino­ l, 3dimefhylulacil >Hydroxypiperidine 2.5­ Dimefhoxy~­ nitroEhlorobcnzenc 3­ Bromobenzoaitrile 3­ Bu1oxypropioNtd~ chloride .O .O ­ 81.9­ 86.0 loo 94.0 16.0 204 10.0 15.0 3 .a, 34.9 6272873 + 81 3 6281407 ­ . 6292688 ­ 6291311 +I246 6298197 +1213 6318510 +988 6358441 +713 6392461 + 2 I3 6SO5155 + I238 6553964 . + 1 Ib 6630053 +7 3 6631374 t 1250 6642315 +I163 6859990 +12w 6940S30 + 1250 69525% +I250 6385% ­ . 6452615 ­ 6959713 ­ + 100 +470 ­ 0.26 3.00 21.0 43.0 83.0 ­ ­ 1­ 00 .O 10.0 42.0 0.00 7.00 0.00 0.00 0.00 I .. .­ . .,. . .......... ~ ................................ ..................... ... ...... .... .... + 825 + loo + 1250 ­900 + I75 + 163 ­ ­ ­ + 37s + 950 + I247 + 888 + 1238 + 863 + 738 + 1125 + 11so + 1157 + 893 ­ w9 + 1238 ­ ­ 2 ­0 ­ 7 ­3 ­ + 1230 ­ ­ + 12% + 1130 + 373 + 1213 + loo ­ 613 ­ S63 ­ ­ ­ + I173 + 238 + 5% + 1063 + 1213 + 1050 + 1238 ­ ­ 34.0 92­ 0 ­ 0.00 28.0 ' 86.0 87.0 ­ ­ 70.0 24.0 0.260­ 22.0 29.0 1 ­00 ~ 31 .O 41­ 0 W. 0 8.00 1.47 32 ­0 47.3 98.0 93 ­ ­ 1.00 ' ­ ' 1.60 ­ ­ 0.00 9. e 97.0 3.00 92.0 51.0 SS. O"~. S, ­ ­ ­ 6.13 81 ­0 56.0 15.0 3.00 3.70­ 16.0 1 .oo ­ ­ .., .. . ­. ". .. ,.. ". .. . , ­ . Name Te~ rakis~~~ unlamino~ rin~ chloride SD 3450 4­ Benzoylpyridine C( pChlorobenzoy1) pyridine Phoxim Tns( elhylcnediaminc) nicLel Triphenylkad phenyl sulfide Wioacetyi iriphenyllcad Diphenyltin dilaurnte RE 54% 2,4. S­ Trichlorobenrencsulfonyl Dioctyltin malate I ,2­ Di& rcaptobu~ 2­ Pyridylacetic acid hydrochloride Bayer 22893 Ba yer 78 17s 3­( Pentyloxy) propionilrik 3­ Octyloxypropancnitk 3­ Decyloxypropanenitd~ Methomyl Ethyl Cnitrophenyl carbamate Bis( n­ oclyl) tin diacetatc Dodecylamine picnle Dicapthoxon Bayer 72368 Bayer 70658 Bayer 62414 3ayer 80564 Bayer 80565 Baser PI174 Diphenjldi~ in~ lsilanc Bayer 50536 Diisobutylamine hydrochloride Tetradecyl chloroacmte ­ . 4­( 3­ Phcnylpropyi) pipcridine Bayer 69047 3$­ Di­ rr­ butyl~ alicylic acid Chlordimefom hydrochloride Rlargoairl pipcridide Tin oxide Fenamiphor 1­( 3,~ Metbylcmdioxy) pbenyl­ win 291% chloride chloride 2­ S& ToCihem 15390995 + 1063 ­ 15.0 IS590779 +838 1600 33.0­ 61.0 8.00 100 14590780 ­ ­ ­ 80.0­ 100 15827142 ­ ­ ­ ­ 50.0 ­ 15942480 +188 42.0 85 R ­ 1S945070 16091 182 16128680 16179978 1621 1066 16548122 16728475 16728497 1672851 I 167S27lS 17576419 17586946 1 762341 5 17650769 17826276 17826334 1782642 17826447 17826458 I '8x48 I 1: 93: 6e­ 18151092 I 825 1826 182n866 18495824 19645422 197151% 197m59 20368 132 2165119d 22224926 + 1250 + 1238 + 1213 + I193 + 700 ­ 0.00 1 .bo 3 .00 4.60 ­ 44.0 c 40, O ­ ­ 0" 0.00 20.0 70.0 100 .60* 0 70.0 3 .00 85.6 14.0 98.0 49.0 + 1213 + 180 + 1075 + 638 + 4% 4.25.0 ­ ­ ­ ­ 1150 +m + 938 +713 *363 ­ +w + 963 + 325 ­ 100 ­ 56; +n5 ­ + 1600 ­ . 42.0 1070 1070 320 710 710 710 140 ­ I ­ ­ 470 ­ ­ 64.0 ­ ­ 8.00 39.0 80.0 Z. 0 43.0 71.0 24.0 23.0 74 .O 38.0 92.0 ­ 40.0 10.0 ­ 18.0 ­ 22482135 22683123 + 130 ­ 21.2 89.6 44.7 ­ 98.2 87.7 CDimclbylaminosalicyIic acid Formclanate hydrochloride 3­ Phcnylpropyl mercaptan Polycthylenc suffidc Bayer 91273 Bay= 46676 Bayer 518% Tetmhydrodithybxadiazine­ 4­ thione Pol~ iutyltin mehcrylale optunal 2305091 1 24353615 23422S39 24134687 24936672 25205087 25537466 25918, VI 28.0 94.0 ­ 18.0 42.0 ­ 24?.~ iuopropenyI) fufuran 33322202 T" chlorophenyi aCClale 33639246 Chemapro 5461 34491428 . h', h"­ Dimcthyldiniuocvbanilidc 34594473 ~.~.& Tfichlorobenrene sulfonyl chloride 34732097 1.(~ Aminohexyl)­ 2­ pyrrolidinonc 3475. 1423 h a d mcthylmercaplide 35029960 ~. 3~ yclopentanediruKonyl dlfluoridc 3594473 I D0u; o I" .;. zYUPX ~W C O 133 GC 4276 firam cyclohcxilaminc complex 36530231 Diphcnyllead bis( d1ylarsonate) 36654076 h a d benzylmercaptide . *. 36688809. +Ami~ 2.2,6. Cte1rethylpipcrdine 3 6 7 m 4 Mcthcnamimallyl iodidt 3689x2 onyxidem . 3733% 83 Sulitc S 37338428 Cyclohexylmethykyclohex~ lphcn). lu~ a 37942726 Hydroxymethylpyfidinc carboxylic acid 38116619 Diphenyllead bis( meLy1anonate) 38873391 Onyxide 3300 39387423 Diphenyl­ p­ phenyknediamiric 39529221 Nickel trifluoracetate " 4062 I076 Diiosophoronc hydrazone 42398174 Lead propylmercaptide 58285520 &tu­ Proproxyproprionitrik 5 1 299822 f Pyridylmethyl h'­ 4'­ nitrophcnyl . carbamate 5 I594833 f'yridylmethyl (rncthylthio) phen> i carbamate 5 1594864 Cmtonylcarbutamide 52964428 Phenyl­ and nephthylamincmixture 530284 14 I­( CAminobulyl)­ t­ pyrrolidinoae 53653648 ~ce~ Y~ cyclohex). lmethylcyclo~ x~ l~~ 53710615 .... .. ... + 137 + 1225 + 425 + 1213 + 1213 + 1 1 0 0 ­ ­ 75.0 ­ 7 .a ­ 25.0 f 200 +613 ­ ­_ . +I 1 3 8 +913 + 180 + 107s + IO63 + 863 ­ .­ ­ ­ + 50.0 ­ ­ + 350 ­ 210 ­ ­ + J240 + 36.6 ........... ... s ...*.. 81 ­0 10.0 0.00 3.00 " 1t. 9­ 22.4 61 .O 29.0 S. 0 97.0 61 ­0 1.00 2.00 0.00 2.67 4.00 67.2 ­ ­ ­ ­ 89.1 64.0 2­ 00 3­ 00 3.00 12.0 ­ w .O !GO M. 0 98­ 0 ,SLO ­ ­ 9.00 , ­ 27.0 83.6 14.0 15­ 0 31.0 96.2 ­ ­ ­ ­ ­ 26.0" UJ' 70.4 22.3*­ 31.7'83.2 ­ ­ 1600 ­ 0.800 +480 97.1 ­ It Methyldihydrocitnzinatc Bayer 80283 Styrenated phenols brro­ lsobutoxypropionitrilc btru­ I~ myloxypropionitnle Mixture of polybutylated bisphenols u 12171 Cocoamine. ethoxylated Bayer 47940 Bayer &X64 Bayer 38500 hlyuiphknyltin melhacrylate Age Rite Resin l­( 3­ Thiouridopropyl)­ 2­ pyrrolidinone Oleyl carbamate m y 28764 ~Z­ Aminobutyl)­ 6. fluoroindoIe ktrakis( n­ hexylamino) boronium I. bBis(( 3­ oleylamino) propylkhiouru Phenylacridinium thiocyanate h y e r 56200 Bayer 50512 Bayer 5 6 5 % Bayer 51932 Eayer 527S2 Bayer 60830 hydrochloride C b l o r i d r W55562 ­ 57oW872 ­ S7157810 ­ S8936280 ­ S8936291 ­ 60616946 ­ 61164m + 1213 61791148 + 1200 63981 113 + 37.5 6420S221 + 125 65324063 + 138 68864040 +I13 74764617 + 1146 74893075 + 1238 69772141 ­ 74987874 . + 1075 . 816Q3641 +p 82679865 + 1075 82679887 + 25.0 8267991 2 + 363 82679923 + 1013 82980447 + 813 82769876 ­ 82679901 + 375 82980436 ­ 25.0 82980469­ 138 ­ ­ ­ ­ ­ 3.00 4.00 97.0 90.0 89.0 91 .o 8.27 *< 1 .00 11.0 82.0 14.0 98.0 70.0 71.0 19.0 98.0 93 .O 89.0 ­ Tesi abbreviations used as follou­ s (see text for detailed description): LDfr­.+ mount of chemical ingei! cd during the FR test uhich illled or did not kil! more than .W of the test mice ALD­.+ pproximate Lethil Dc* r tacute orslr: mJiaics an lD>@ FR­ Food Reduction RSI using 2. m­ treated wheat Keds FRdf­ Same as R1 except that Douglas fir seeds were used REP" Percentage of mice refusing Io eat more lban ­XE of ?.@%­ treated wheat available ud lib. Momlit). and the amber of wheu seeds con­ sumed daily were recorded. fbe I d number of treated seeds consumed by all mice over the 3 d a y test period were subtracted from tbc total number miiablc. The difference was convened into &e percentage of reeds refused, and the value w s desig­ oated as the FR (Food Reduction). For highly repellent or toxic chemicals. the FR test war fol­ loued by another test using treated Douglas fu seeds. These seeds more closely represented rht durable and inedible seed coats encountered by wild rodents that cause reforestation seeding problems. Test procedures were similar to those used for the €3 lest. except that the test chemical concentration was I.@%. Values resulting from this test were designated as FRdf. The third repeliency lest method u& d house mice and 25 white wheat seeds treated with 2. W. ol the candidate chemic+ The wheat seeds were offered IO 10 individually caged mire for a 5­ day period along with the same alternate food used in the FR test. ?he lest results. designated as REP, are summarized by the p­ centake of mice refusing to eat an avenge of 13 or more treated seeds per day during the ,May test period. Toxicity T\ Wo acute d toxicily tests were .Is0 conducted on deer mice. The fmt. tbe ALD (Approximatt Lethal Dose). represented a range­ finding modification of& Dcichman and LcBlanc (1 5 ~3 1 method using approximatcly 6 rnimals and a pndualed dosap scale. Using this single animal per level methd, each succeeding treatment ­as 505 higher Ilw UIC preceding level and continued until mondity occurred. All chemicals were administered by gavage using wafer. corn oil. or 1.0% carbopol as cam'ers. fd, towed by 3days d observath for monality. The second iox­ icily test (L& I was conduacd on I more limitedbasis III a similar manner. except that 2 to 4 animals­ were used per pee metrically spaced dosage kvcl. Tbe statistic& method used IO estimate the acule o d wr>, was that of Thompson (19481 and lhompson and Weil( 19S2). Thcse tests gemrally requ~ rd from 6 to 20 animals per expcrimtnr. The final .set of toxicity data uas derived from the FR value. rbe known average weight of mdr vidual wheat seeds (SO mgl and the known average. u. clpht of each individual deer mouse (20 gm). Tbis calculated value. ~h c g c s u l ~ me results of the tests conducted with 933 &mi­ cats are presented in Table l . Of the chemicals Icsted. ALD's (or LDs'S) on deer mice were avail­ r ~c for 230 chemicals, FR's (and usually LDfr's) far 696 chemicals and REP values on house mice for 347 chemicals. No statistical correlations were attempted between FR and ALD or LDM values or REP and ALD values, because of the multi­ day na­ of the FR and REP studiesand the approxi­ mation assumed by the ALD. We feel that the ALP or LDfr and the FR and/ or REP values could be used to generate potential hazard indexes for acuie andlor subacute exposure of wild mammals to chemicals in the environment. Such an index, or even a visual interpretation of the data presented. should provide ihe reader­ with an lpproximate idea of the potential for ingestion and ~ubsequent mortality in wild mammalians exposed to the listed chemicals. Such an index, if generated and defined as the one proposed by Schafer et a[ 4 1983). may serve as an additional predictive tool in determining potential mammalian mortality lowing envirunmental exposure to chemically con­ taminated or treated fdod. I 4 2 9 Artno@. lrd~ mrnfr. The authors wish lothrnk !he following in­ dividuals fop their assistance on cdkctimg. typing and editing the data contained in this publication: M J I ~ Eschen. Patrick Fundcrburg. David Hayes. Glenn Hood. Brenda Lcchup, Ce cila Nelson. Florence Poe. and Peter slv. rie. RK compilation 8d prcwration of the data included in this publication was sup ­ported. in pan. through Interagency Agreement 14­ 164009­ 8l­ 957, whichwas funded by the U. S. Environmental Protection Agency. Ollicc of Toxic Substances, Washington, X. References Deichmann W. LeBlanc TJ (1943) Determination of the approx­ imate lethal dose with about six mimais. J Ind Hygiene Tox­ KGem NB (19541 Development of better .seed protectants. J Forestry 52~ 826­ 827 Kvemo NB. Hood GA. Dodge WE( 1W) Development ofchem­ i u l s to control forest wildlife damage. hac SOc Amer For­ Schafer EW Jr. Bowles WA Jr. Hurfbut JIlW13) The acute oral toxicity. repellency and huvd potcnlirl of 998 chemicals to one or more species of wild and domestic birds. Arch En­ viron Contam Toxicol 12355­ 382 Thompson WR (1948) Ux of moving rverages and interpolation to estimate median effective dosc. Bacterial Rev. 11: I 15­ 145 Thompson WR. W i l CS (1952) On the constmction of tables for moving average interpolation. Biometrics 831 ­54­ icol Tj: llS­ 417 tSten 65~ 222­ 226 ...... .. .. ... ................. .. .. P STUDIES ON DRUG ABSORPTION FROM ORAL CAVITY: PHYSICO­ CHEMICAL FACTORS AFFECTING ABSORPTION FROM HAMSTER CHEEK POUCH y~?] KUROSAKI, NORKO AYA (nee YAMASHITA). YUhllKO OKADA, TAU] NAKAYAMA AND mol o i TOSHIKIRO KUIURA" Ptctle (Received August 27,1985) Keywords "8bsorption; oral mucosa; hamster cheek pouch; pharmacokinetics; physico­ chemical factor; salicylic acid INTRODUCTION In this paper, we describe a new experimental The absorption of drugs from the oral cavity method for studying absorption processes across has been investigated by the buccal absorption the keratinized oral mucosa in vivo usinga ham­ test of Beckett and Triggs" in man. In these stud­ ster cheek pouch, which consists of keratinized ies. it has been shown that the ability of a com­ stratified squamous. epithelium, and discuss pound to cross the oral epithelia is highly depen­ some characteristics of drug absorption through the lipophilicity of its unionized form.*" 1 The oral mucosa has been classified into three types MATERIALS AND METHODS according to function; i. e., masticatory, lining Chemicals ­All chemicals usedwere rea­ and specializedmucosa.. Also rhere are regional gent grade commercial products. . variations i n the epithelial thickness and the Procedure ofAbsdrption Experiments­ Male degree of keratinization. 5) Although the buccal golden hamsters (80­ 110 g body weight) were absorption test in man can easily provide data anesthetized with urethane (1.5 g/ kg, i. p. ) and concerning the absorption rates of drugs admin­ were fastened to a platform at an angle of &ut istrred in the oral cavity, the test does nor show 5 5 3 The cheek pouch was cleaned by multiple ~h r regional differences in the absorprion rates6) rinses with saline and the iumen was wiped with o r the rate­ limiting step( s) (permeation barrier) cotton balls to remove excess water. A vinyl of the absorption process. 5.6) Studies on mucosal tubing (0. d. 1.2 nun, i. d 0.8 mm, Dural Plastics, permeability to drugs in virro, using diffusion Australia) was inserted into the cheek pouch and cetls, provide valuable information concern& the was fsed with Aron Alpha (Toagosei Chemicals, relationship between the rare of transfer and the japan) to the corner of mouth in 40 mm depth physico­ chemical properties of substances such (Fig. 1); Drugs were dissolved in appropriate as Lipid solubility, molecular size, chemical com­ isotonic buffer solution (citric acid­ Na, HPO, at position and abiliy to form hydrogen b ~n d s ,~­~l ' p H 2.0 to 5.0 and NaH, P0,­ Na2HP0, ar pH but no information concerning the transfer pro­ 4.0 a d pH 7.0). One ml ofthe drug solution was C ~S S frbm the oral tissue to rhe, sy, stemic circula­ admin­ isrered into the cheek pouch. After stand­ ing for a definite period, the luminal contents . , dent upon both the degreeof its ionization and a keratinized region of or­ al mucosa .* TO whom correspondence should be addressed 288 were withdrawn and the cheek pouch was washed with the same buffer solution. The wash­ ings were combined with the luminal contents and made up to 20 ml by addition of saline. The amount of the drug remaining was determined. The disappearance from the lumen was defined as the apparent absorption. Determination of Salicylic Acid Remainiwin Tissue of Cheek Pouch ­in some absorption ex­ periments for salicylic­ acid, the amount of the drug remaining in the tissue of cheek pouch was vinyl tubing (0. d 1.2 mm, i. d. 0.8 mm) FIG. 1. SchematicRepresentation of Absorption fiperimenl f o r Hamster Cheek Pouch Y. Kurosaki, el ai. determined. After washing out the residual salicylic acid, the cheek pouch was irnmedately cut off, A half N KaOH solution was added to the tissue to make the total amount 20.0 g. The­ tissue in alkaline solution was then placed in a boiling water bath for 30 min. After cooling the resultant solution, some impurities were extracf­ ed with chloroform. The remaining aqueous phase was .made acidic with concentrated HCl and salicylic acid was extracted with chloroform. Then, salicylic acid. in the organic phase, 'was re­ extracted with 0.1 hT NaOH solution and the drug in'the final aqueous layer was determined by a high pressure liquid chromatography (HPLC). For the calibration curve, appropriate amounts of salicylic acid were added to the tissue of cheek pouch and the same procedures were carried out. Analytical Methods "p Aminobenzoic acid and sulfisoxazole were diazotized following a regular procedure, coupled with 2­ diethyl­ aminoethyi­ 1 ­naphthylamine and extracted with isoamylalcohol after addition of 1 g of NaCl. The optical density of the organic layer was determined at 560 and 555 nrn, respectiv$ ty. HPLC was used to determine the other com­ pounds remaining in both lumen and tissue of the cheek pouch. The chromatograph was 5703 (Gasukuro Kogyo, Japan) equipped with a ultra­ violet (UV) detecror (5025, Gasukuro Kogp). TABLE 1. HPLC Condirions. for the Anabsis qf Test Compounds Compound Mobile phase" ' Wave­ length (nm) . Salicylic acid 45 : 55': 21 5 Phenol 50 : 50bi 220 Benzoic 4 0 :6 0 b t 227 Acetylsalicylic acid 50 : 50 " 220 Propionylsalicylic acid 50 : 50 b' 220 Butyrylsaliqlic acid 40 : 60° ' 220 m­ Hydroxybenzoic acid 50 : 50h' 300 p Hydroxybenzoic acid 50 : 50b' 253 0­ Toluic acid 30 : 70 ' I 220 Anthranilic acid 70: 30: 3'' 248 Acetanilide 40 : 606' 237 Acetaminophen 40 : 60 bl 240 Phenacetin #:& Ib) 243 Methylparaben 35 : 65 b1 254 Ethylparaben 30 : 70 '1 254 Propylparaben ­ . 25: 75b' 254 a) Valuesareexpressed as volumetovolumecomposition of two orthreecomponents. . b) 0.025'~ phosphoric acid : methanol. c) H2 0 : acetonitrile : aceric acid. .. D T. C P' f f sa P' Pi Ot m u' ca Tht. column used was a reversed­ phase Unisil Q c: 1 8 (4 .O x 3( K) mm, Gasukuro Kogyo). Mobile +ses and the wave­ lengths for determination summarized in Table I . An aliquot of the simple soluti'on was filtered through a 0.45 p m pore­ size triacetylcellulose membrane (Fuji Photo Film, Japan) and an appropriate volume (,(­ the filtrate was injected into the liquid chro­ matograph. The concentration of the compound u'; ls calculated from the peak height using the c; ilibration curve. Plasma Concentration of Salicylic Acid ­Under urethane anesthesia, the carotic artery was cannulated with polyethylene rubing (0. d. (1.8 mm, i. d. 0.5 mm, Dural Plastics) and then heparin (500 unitlkg) was administered intrave­ nously. In a n . i v . administration study, salicylic acid was dissolved in saline to make 20 mM and was injected into a femoral vein (1 mVkg= 20 pmol/ kg). In the study of intra­ cheek­ pouch ad­ ministration, salicylic acid dissolved in isotonic buffer solution at the concentration of 10 mht was administered into the cheek pouch in a simi­ lar manner as described in Procedure of Absorp­ rion Experiments (10 ml~ kg= 100 pmoVkg1: in ht. h studies, blood samples (0.2 m l ) were col­ lected periodically from the cannula for 4 to 6 h after the administration and the plasma was separated immediately by centrifugation. Afrer addition of acetonitrile, the plasma was cenrri­ fuged and the supernatant ?as filtered through a 0.45 pm pore­ size filter (h'ihon Millipore . Kvgyo, Japan). Salicylic acid concentrations in plasma were determined by HPLC equipped yic h a­ fluorescence detector RF­ 540 (Shimadzu; Japan) at 300 anh 430 nm for elcitation and emission. respectively. Pharmacokineric Studies ­Plasma concen­ t r a t i o n ­t i m e d a t a f r o m i. r. a n d i n t r a ­ cheek­ pouch administration studies were simul­ taneously fitted to a two­ compartment model (F I ~ 6) using a. nonlinear least­ squares program, hlULT1. '2' In'this model, the parameters of Iag times and absorption rate constants for two intra­ cheek­ pouch administration studies were independent of each other. Determination of Lipophilic hde­ x. log (k ;I, at p H 3.0 ­The lipophilic index, fog (k b), of each compound at pH 3.0 was derermined by reversed­ phase HPLC according to the method d Yamana er ~l . 13) The apparatus for HPLC HJS the same as described in Analytical Methods and all compounds were detected at 254 nm. The mobile phase of methanol­ buffer solution (pH 3.0) made of 12.6 mM citric acid, 6.4 mM Na, HPO, and 10 mht NH, CI was run at a flow rate of 1 .O rnL'min. Ammonium salt was added to block the acrive siianol sites of the column. Formamide was used as an unretained substance. When log (A"). which w. as defined as follows; where t R and t o are rhe retention times of a retained peak and of an unretained peak, respec­ tively, was plotted against methanol concentra­ tion (v/ v %), reasonable linear relationships for ali compounds tested (r < ­0.999) were ob­ tained. The lipophilic index, log (kb), was defined as a log (k') value extrapolated to 0% methanol. RESULTS Absorptionfrotn the Hamster Cheek Pouch pH 3.0 from the hamster cheek pouch was exam­ ined. Table I1 summarizes the results of the ab­ sorption experiment. The percentage of absorp­ tion of compounds from the lumen of the cheek pouch i n 1 h varied over a wide range. In the case of alkyl acid esters of salicylic acid, the ab­ sorption increased as the alkyl chain­ lengths in­ creased, i. e., acetyl­ < propionyl­ < butyryka­ licylic acid. Similarly among parabens, the ab­ sorption increased in the order of methyl­ < ethyl­ < propylparaben. These results are in . agreement with the buccal absorption data of ~~ '­ n­ alkylarnin~ s.~ ' The absorption of both m­ hydroxy­ and p ­ hydroxybenzoic acid, the struc­ tural isomers oi salicylic acid, were about one­ tenth of salicylic acid. Likewise, for aminoben­ zoic acids. the 0­ isomer (anthranilic acid) was . more absorbable than the p ­ isomer. Elkcr of Llrrnirlcl Concentration on zhe Absorption q f Saliqslic .4 cid The effect of luminal concentration of salicylic acid on its absorption from the cheek pouch was examined in the concentration range of 1 .O to 10.0 m5f. The percentages of the absorp­ tion in I h ar pH 3.0 were 48.6,498 and 48.2 at 1 .0, 5.0 and 10.0 mhi respectively (Fig. 21, show­ ing the linearity o i salicylic acid absorption in the concentration­ range examined. Time Course ofSali& c Acid Absorption To clarify the process of the absorption of a drug after inrrz­ cheek­ pouch administration. 10gW) = 1. i N t R ­t<))/ tol (1) The absorption of 18 aromatic compounds at . 'i t t TABLE 11. Ahsorpi< w (? f M( lCkd Conlpouttdsfrom rhr Hamster Check Pwch arpH 3.0 t ion P i a Molecular Conc. c/ c absorbed in tere Compound weight (mM) 1 ha' the Phenol ' 94.1 1 .o 34.62 2.6 (4) pro1 Benzoic 1.0 37.62 1.5 (31 t imc Salicylic 1.38.1 1 .o Acetylsalicylic 1 ­0 11.1 f 1.6( 3) seer Propionykalicylic acid 194.2 1 .0 25.7 2 1.9 (4) mol Buryrylsalicylic 1 .Q 40.8 5 5.5 (4) sali m­ Hydroxybenzoic acid 138.1 5 .o 6.3 2 0.8 (4) a i t t p ­ Hydroxyhcnzoic acid 138.1 5 .O Oi 5 u­ Toluic acid Anthranilic acid : ­ 137.1 p­ Aminobenzoic acid 137.1 1 .o . squ Sldfisoxazole 267.3 kln Acetanilide 135.2 1 .o 7.7 2 19 (4) 111. Acetaminophen 151.2 I .o 0.9­ t 0.5 (4) rim Phenacetin 179.2 1 .o 16.0 ­t 0.6 (3) tru Methylparaben 154.2 1 .0 30.1 f 2.5 (7) anc Ethylparaben 166.2 1 .0 44.8 k 0.8 (4) cor Propylparaben 180.2 0.9 64.6 +­ 3 2 (4) 48.62 4.1 (4) . J i i l 6.5 2 0.7 (4) 136.2 1 .o 50. Gk 3.0 (4) 1 .o 14.3­ t 1.6 (4 ) a 8.6 k 1 .O (4) 1 .o 6.0 2­ 0.7 (4) c w s R ~~~/~~ are eypri> ssedas the mean 2 S. E. with rhe number of aperiments in parentheses. salicyiic acid was administered and the arnounrs of salicylic acid remaining in both the lumen and the tissue of the cheek pouch were period­ caliy determined ar pH 3.0 and at pH 4 0. Re­ sults are shown in Fig. 3. The semilogarithmic plots of the luminal salicylic acid (open circles) indicated that the drsapprarancr from the lumen could he described by'a biexponential process. f­ Iowewr, the rransier to rhr systemic circularion (closed circles) was shown to be an apparent first­ order prociss at both pH conditions. AC­ cordin&, it is rcasonddt to consider that the ­systemic transfer after inrra­ cheek­ pouch ad­ ministration can ht approximared by the first­ order process after a lag time. The apparenr transfer rate consranrs t6 the systemic circulation calculated from rhr slope `of rhr clcked circles and the lag Times estimated by extrapolation were 0.49 `h­ 1 and 7 min, and. 0.11 h­ 1 and 25 min for pH 3.0 and pH 1.0, respeaively. Plasma Concentration ojSaIi@ ic Acid a$ er Inrra­ Cheek­ Pouch Administration Plasma concentrations of saliqlic acid after intra­ cheek­ pouch administration (100 KmoVkg) as a function of time are shown in Fig. 4. The plasma level wsus time curves were clearly dependenr. on' the pH of the administered solution. When salicylic acid was administered at pH 3.0. the plasma concentration was rapidly , ­ increased t o abour 100 nmol/ mi and then de­ creased thereafter. On the other hand, ar pH 4.0, it took about 1.5 ­ 2 h to reach the maximal con­ centration of about 25 nmol/ ml and this concen­ tration was maintained for at least 5 h.. Pharmacokinerics of Salicyiic Acid after lnrra­ CheeA­ Pouch Administration To confirm the plasma elimination kinetics of salicylic acid in h m t e r s , an i. r. administra­ 5 10 Iniria! cnncrnaauon (rnd h o s a k i , et a/. arion kinetics . a+ ninisrra­ ­q­ f l ,)(l wds carried out. As shown i n Fig. 5 , the p l ~~n ~a concentrations of intravenously adminis­ rcred salicylic acid declined biexponentialty. As tilt ahsorption from the cheek pouch can be ap­ ppximared by tbe first­ ordgr process after a 1% 1 imc (Fig. ?), the two­ compartment model with '1 tlrst­ order absorption process shown in Fig. (1 sctmrd to be available as the pharmacokinetic model for intra­ cheek­ pouch administration of salicylic acid. Plasma concentration­ tim& data attrr intra­ cheek­ pouch and i. c administration ~1 t ' salicylic acid (Figs. 4 and 51 were simultane­ ously flttcd to the model using a nonlinear least­ squares program, MULTI. '2' and the pharmaco­ kinetic parameters estimated are listed in Table 111. The absorption rate constant, k a, and the lag time, 5 , estimated here agreed with the apparent , transfer rate consrant for the systemic circulation and the lag time obtained from Fig. 3 at each pH condition, respectively. EJfcct of Lipophilici! r on tlw .4 bsorprion from thc Hanlstcr Chcek Pouch log (li 7 values together wirh log values for 18 compounds at pH 3.0 are listed in Table I V . I t has been shown that the absorption from the oral mucosa is related to the lipophilicity of the compound in horh in I ~w ~­~.~~~ and in correlation (r= O.? 64) berween log t k i) and the absorption rare at pH .i. O. Thr theory of diffu­ sion through a single­ layer homogeneous mem­ brane. predicts for small compunds that per­ meahility is inversely proportional to rhe square root of the molecular weight (,& fr). 15) When this concept was applied, Fig. 7b w'as obtained where rhe'abscissa was altered to log j (A{,) '". A better correlation (r = 0.874) was observed br­ tween log (k b I (Mr) ''? and the absorption rate, suggesting that not only the lipophiliciry but also the molecular size may affect the absorption V/ lilrO 9­ 1 1) experiments. Fig. 7a shows the positive FIG. 3. Time Course of Sali& c AcidAbsorption. fion1 rhe Hamster Cheek Pouch Semilogarithmic plors qf saliqlic acid remaining in lumen and in tissue of the cheek pouch (a i at pH 3.0 and (b) at pH 4.0: 0 , saliq­ lic acid remaining in iuminalfluid: 0 , sun1 of saliqlic acid ren. loining in lumen and in tissue. (el Tusue accumulation of sali~. lic acid: C , pH 3­ 0: c) , p H 4.0. R e d s arc, ex­ pressed as the mean 4 S. E. ofaat leas1 three ex­ perimenrs. Y . Kurosaki, et a/. 292 from the keratinized oral mucosa. EIffecr of pH 011 thc Absorpiion. fron1 rhc Hamsrer Cheek Pouch To determine the effect of pH on the absorp­ tion from the hamster­ cheek pouch, absorption 2oo t 4 I 0 1 2 3 4 5 6 Time (h) FIG. 4. PIasma Concentration of Salit?­ lic Acid affer Intra­ Cheek­ Pouch Adminisrrariolr 100 p nt0Vh­ g of saliqvlic acid. was ateltzinistered into the cheek pouch: C , pH 3.0; e. I.. ' '4.0. Re­ 1 sults are expressed as the mean i­ S. E. ,f a t least three 'experiments. Each line represenr.;. ihe curve $nedwith the wo­ comparrmenr modc. shown in Fig. 6. experiments were carried out for salicylic acid, benzoic acid and phenacetin. Fig. 8 is the plots of absorption as a function of pH. The pH change was negligible throughout the experiment. The absorption of both salicylic acid and benzoic ancid were decreased with the increase of the pH of the solution and almost nil at pH ?. o, where these compounds n: ere complettly ( >99% 1 ionized since the pk', values were 3.0 and 4.2, respectively. On the other hand, the ah­ sorption of phenacetin, which is not ionized in thepH range examined, was not affected by the pH. These data suggest that the ionized form of the compound was poorly absorbable from the hamster cheek pouch although the inflection points of the pH­ absorption curves were slightly shifted to the basic side compared with the, pK, values in both acids. DISCUSSlON The morphology of the oral mucosa varies from regi0. n to region depending on function. It is likely that there are differences in permeability among structually dfferent regions of the oral mucosa, such as keratinized or non­ keratinized. 6) One of the simplest methods hrercly measuring permeation rate through the oral mucosa in vivo is buccal absorption test of Beckett and Triggs." in this method, the uptake of a compound is es­ FIG. 5. Plasma Concenrration of Salicylic Acid after i. v. Administration in Hamster ­20 pmoVkg of salicylic acid was injected into the femoral vein. Resulrs are =pressed as the mean k S. E. of three aprimenfs. Line represents the curw fined uith the two­ compartnlenr model show in Fig. 6. ­ FIG. 6. Pharmacokinetic Model for Salicylic Acid in Hamsrer D or D' , dose: t o , lag time; k,, first­ order ah­ sorption rateconsrant; k,, .firsr­ orderexcretion rate consrant; k and k z,, .first­ order transfir rate constants betneen two comparmlents: 1:. volume of disrribution of censral comparmwnc V2, volume of distribution of peripheral comparr­ ntenf. Saliqslicacidwasadministered br i. r. or infra­ cheek­ pouch administration. Drug Absorption. fiom Hamster \ Cheek Pouch rrn, ilrccf from t'hr differences in amount hetween initial and the final solutions in the mouth. Hrtu. ever, this method cannot provide informa­ rlon as to the relative permeability of differem regions in the oral cavity, because the area where the absorption may have taken place cannot be tclnfirmed. In addition, since the measurement ­; IS carried Out in human volunteers, the test conditions should be restricted; that is, the ;q: cnrs nhich are thowht to damage the biologi­ c SI membranes cannot be used for studying the permeation barriers. Furthermore, the data from untrained volunteers showed wide deviation in this In­ wlro methods, usually using diffusion cells, enable anatomically well­ defined regions of mucosa to be studied, but cannot pro­ vide information'concerning the transfer from oral tissue to systemic circulation. In this study we used a hamster check pouch, which has keratinized suatified squamous epithelia") simi­ lar to those of gingiva aid hard palate in man and which could be well separated from the Pharmacokinetic parameter Condkion of administration pH 3.0 pH 4.0 0.103 to (mid 8.4 24.0 k, (h ­9 ' 0.529 k, (h ­I) 2.25 v, Wkg) 0.125 V , (Vkg) 0.185 k 12 (h 1.05 k2i (h ­') 0.7 1 Thc parameters were estimated by Ihe damping Gauss­ New: method. Since the anabrical limir ofthe plasma salicylic acid was less than I nrnofml, the reliabiliw Ofii e data appeared to be equivalent in each paint. Thus, in esrimarion, (CJ­ 2 was adopted as the weight wht: e Ci is the value ofthe i­ thpoint. Aka& e> information, A K , in this estimation was ­1 9.3. TABLE IV. Lipophilic Indexes of Model Compounds ar pH 3.0 Phenol ­2. Benzoic acid Sahcylic acid Acetylsalicylic acid Propionylsalicylic acid Butyrylsalicylic acid m­ Hydroxybenzoic acid p­ Hydroxybenzoic acid o­ Toluic acid . Anthranilic acid Sullfisoxazole $­ lit Acid p­ Aminobenzoic acid order ab­ Aceranilide i? vcwtion Acetaminophen N. D. b' ­0.367 ­0.1 13 0.1 16 0.344 1.06 ­0.514 ­0.212 0 .c 39 0.392 N. D. 1.60 N. D.. ­0.513 ­0J12 0.103 0.414 1.42 .p . N. D. ­0.486 ­0.1 74 0.1 03 0.412 1.30 ­0.596 ­0.253 0.( 92 0.450 N. D. 1.84 ­ 037 1 "0. W 0..:, 77 0.770 N. D. 2.30 AT. D. ­0.678 ­()..; a ­0.058 0.252 1.18 N. D. ­O. 'U ­O.­ i23 ­0.127 0.171 1.09 N. D. ­0.405 "0.1 29 0.1 31 0.385 . 1.18 N. D. "0812 ­0.439 ­0.046 0.389 1.57 ­0.320­ 0.001 . 0.116 0.64 7 N. D. 1.93 N. D. N. D. "0.682, ­0.388 ­0.110 0.75 N. D. ­0.340 ­0.084 0.1 74 0.455 1.24 N. D. ND. ­0.824 ­0.549 ­0.253 OM, N. D. 1.69 N. D. 1.70 N. D. 2.1,7 a) A~ obi~ ePhQse. 61 .% t determined. Results are expressedas the mean of drrpIicafe aprimena. Phenaceti; Methylparaben Ethylparahen Propylparaben ­0.441 ­0.153 0.1 5 1 0.477 ­0.522 ­0217 0.102 0.430 ­0.328 0.006 0.364 0.746 ­0.1 18 0258 0.658 N. D. N. D. 2.59 other oral mucosa during the absorption experi­ ment to investigate (ii the process that a com­ pound administered in solution disappeared from the lumen of the cheek pouch, (ii) the pro­ cess that the compound transferred from the cheek pouch rissur into the systemic circularion and (iii) the factors affecting thost processes. It has been demonstrated at various sires thar the absorption r a m of compounds a!­? sorbed by a passive diffusion mechanism c o r ­1ated well with their IipophiIiciry. Recently. I Jered er. at. using the human buccal absorption :est showed that there are carrier­ mediated tranyon systems for nicotinic acid. nicorinamide, lE thiamineIg) and glutathione2" in the human oral cayity. In the keratinized mucosa including h; mter cheek pouch, however. the carrier­ medm ed transport system may nor exst. As shown in ''igs. 2 and 8.­ the absorption oi s211cylic acid vas increased linearly with the dosr and was pji­ dependenz. namely, the absorption was poor x thehigher pH regions whert This compound x 'as compkte­ 1y ioniztd. in addxion, there was a [mirive corrc­ larion between rhr absorption x e s and the lipophilic indexes. which correkxed well with rht partition coefi1aenrs in 1 ­ocr; nol­~ ater,*~ ' with the 18 aromatic compounds lasted (Fig.?). Consequently; it can be assumed tiat the absorp­ tion mechanism from the keratinized hamster cheek pouch is a passive diffusion. There are only a few studies concerning the absorption from the hamster cheek Whitford e1 ai. 23' reported thar the absorptin of fluoride through this keratinized epithelium occurred mainly by diffusion of undissociated acid, HF. and this agrees ell with the present findings. The data presenrtd here involve two prith­. lems to be solved. One is a pH­ shift shown in .ed by a d well ~)r ~l ~~ .4bsor~ l10n./ r~ 7m Namsrcr ChccA Porrc­ h ~~ g 8 . Sin,, the ph', values for salicylic­ acid and t­ rcnzoic­ acid are .3,0 and 4.2. respecrively. the pH­ proiiles of the absorption for both acids U'erc' shifted to basic side approximately 0.5 ­ 1.0 pH unit from each curve of unionized fracrion. The shifts of pH­ absorption curses hSlve already been reported for somr drugs in the psrrointesrinat tract including the oral cayiry 2nd the contribution of physiolopical factors such as a higher acidic pH, if.. virtual pH at the membrane s u ~f a c e ,~~.~~) (he buffering surface s! grm, 16) or drug binding ro the mucosal mem­ brane surface26. L) i1 have been proposed. However, Anmo et al. 2F.) using a recirculation method reported that the absorption of salicylic acid, salicylamide and gentisic acid from the rat oral mucosa agreed well with each dissociation NVC and that the unionized from was preferentially absorbed compared with the ionized form. In rhis recirculario. n method. the recircularing rate of t h i d r u g solution was sufficient1) y rapid and rhe solution adjacent to the absorption surface was well stirred. Recently. Tsuji et al. 29) clearly showrd by in ritro interphase rransport study using a two­ phase rolling cell that the aqueous diffusion layer appeared to he the mosr reasona­ ble explanation of the pH­ shifts observed in penicillins by 0.8­ 2 pH units in rar stomach and small intestine, wirhour application of physi­ ological factors. Although the experimentaf proof must be required, it is difficulr to rule out rht­ efitst of such an aqutnus diffusion iayrr on thy aSsorprion irom the hamster cheek pouch in r h t ­ prritn: expmmental mechgd. Thr other is a birspontnrial loss irom rhr lumen of the cheek pt) uch observed ir! the rime­ course study of salicylic acid absorption {. Fig. ') Beckerr and Pickup3( '! a h s'ncwed rht­ biexponenrial loss of surne­ steroids i r o n the oral cavity in man. in u. hI: h the d1s: ribution phasc was completed u. irhin 5 min. The): used a two­ comparrmmt open modei which meant a reversible membrane storage t e explain the absorption. Since the disrribution phase was compiered within the shvrrest esprrimenral period of 15 min in the present scudy. wc coouId not consrrucr an ap­ propriate modeling under this condition. Hon ­ eyer. :he mechacism of this phenomenon may alsc kt responsibk for the aqueous diffusion layer a well as rht b a c k w d diffusion from the fiscut :o :he i a n x n The syremic t r m s p r : 0: 5 ".1 ~ .,.­ 7 ~ .li <' '..< S C I ~ a t t t r intrn­ chtti­ pouch zdminis­ ,­ ,. 295 tration could he well approximared by the flrsr­ order absorption model including a lag­ time pro­ cess and the absorption rate constant esrimared at pH 3.0 was about 5 times larger rhan that of at pH 4.0 (Table H i ). Similar results were ohrained ­j from the rime course study of salicylic acid ah­­ ! sorption (Fig. 1). However, since the pH change of the tissue adjacent to the blood capillary ap­ d penred to be negligible (though this determina­ tion has not been accomplished as yet), the real 3 transfer rate constant from the tissue to the sys­ 4 temic circularion is assumed to br independent of the luminal pH. Taking into account the larger tissue accumulation of this compound at pH 3.0 in cornparkon with that of at pH 4.0 (Fig. SC). the larger absorption ratr constanr from the lumen to the systemic circulation ob­ tained at pH 3.0 might be due to the faster trans­ fer or the higher partition co the tissue caused by rhe lower degree of ionization at pH 3.0 than at pH 4.0. As to the effect of molecular weight on the absorption from the oral cavity, Siege) cr al. reponed that the permeability coefficients of shon chain­ length alcohols decreased from me­ thanol to propanol and then increased to ocranol, though the olive oii­ to­ water partition coeffi­ cients increased simply with increasing the, chain­ length. '" ' They concluded from the in vi^^^^^ and the in vivo14) experiments that the absorption parhway of oil­ soluhlt compounds is a transmembrane route whereas water­ soluhle molecules with a molecular volume of less than SO crn'~ mmol cross primarily through rnrmbrant pores and iarger water­ soluble molecules pass ex­ tracellulariy. In the present stud?. a mure fayourable correlation could be obtajnrd ht­ ween the ahsorption rates and the IipqMic in­ dexes when the molecular­ weight factor was taken inta account. This is one d t h t reasons uhy the absorption from the krratinizcd hamster cheek pouch is explained by cht­ passive diffusion mechanism. A new experimental method using a hamster cheek pouch proposed in this paper is an availa­ ble method for­ studying both the absorption and the i d l ~.~i n g transfer processes to rht­ systemic circulation. This will enable us to investigate the nature o i the absorption from the keratinized oral mucosa in various severe experimcncal randitions which are never applied to human voltlnrrers in the buccz. i absorption tt'sr. Absorp­ tion characterktia through the keratinized oral branes: The physical basis of ion and nonelectrolyrr mucosa may be clarified by this hamster­ cheek­ pouch method in rhe near future. selr~ iviry, Annu. Rev. Pbysiol.. 31.581­ 646 (19@~ t 161 'X1. Schiirmann and P. Turner.: A membrane model of the human oral mucosa as derived from buccal a b q ,. REFERENCES A. H. Becketr and E J. Trigprs. Buccal absorption of basic drugs and its application as an in vivo model of passive drug rransfer through lipid membranes. J. Pharm. Pharmacol., 19, Suppl., 31S­ 41S (1967). M. H. Bickel and'H. J. Weder: Buccal absorption and other properties ofpharmacokinetic imponance of imipramine and in metaholites, J. Pharm. Pharmucol.. A. H. Beckea and A. C. Moffat: Correlation of partition coefficients in n­ hepatane­ aqueous systems with buccal absorption­ data for a series of amines and acids, 1. Pharm. Pharmarol.. 21, Suppl., 144s­ 150s (1969). A. H. Ekcken and A. C. Moffar: Kinetics of buccal ab­ sorption of'some carboxylic acids and the correlation af the race conscants and n­ heptane: aqueous phase'parti­ tion coefficients, J. Pharm. Pharmacol.. 22, 15­ 19 11970). B. K. Berkovin, G . R. Hoiland and. B. J. Moxham (e&.): Oral mucosa. "A Colour Atlas Bi Textbook of Oral Anatomy." Wolfe Medical Publications Lrd.. Hol­ land, 1978, p. 136. C . A. Squjer and B. K. Hall: The permrabillry of skin and oral mucosa to water and horseradish peroxidase as related ro the thickness of the permeability barrier. J. Invest. Lkrrnarol.. 84,176­ 179 (1985). M. C. Alfano. J. F. Drummond and S. A. Miller: LoCali­ zarion of rate­ limiting barrier to penetrarion .of endo­ toxin chrough nonkeratinized oral mucosa in w m , J. Dent. Res.. 54.1143­­ 1148( 19'5) w'. M. Hill, C. A. Squier and 1. E. Lindrr: A hrsrolcgicd method for rhe v~ sualization of the intercellular per­ meability barrier in mammalian stratified squamous epithelia. Hisrochrm. J., 14.64 1 ­ (48 (I 9S2 i . 1. A. Sirgel and K . T. Izursu: Ptrmeabdrry oi oral mucosa to organic compounds. J. Deni. R e s .. 59. 21,160­ 168 (1% 9). tion performance and physicochemical properties of the B­ blocking drugs atenolol and propranolol, J. Pharm. Pharmarol., 30,13­­ 14: (1778). 1') F. H. W'hitr and K. Gohart: The ulnascrucmral mor. phology of hamster cheek pouch epithelium. Arch OrnlB/ ol.. 26,563­ 576 (1981). 18) D. F. Evered, F. Sadoogh­ Abasian and P. D. Patel: Ah. sorption of nicotinic acid and nicotinamide acroS6 human buccal mucosa in vivo. Life Sci., 27. 19) Dl F. Erered and C. Malletr: Thiamine absorprion across human buccal mucosa in vivo. L f e Sci., 32. 1355­ 1358 (1983). 2 0 ) M. K. Hunjan and D. F. Evered: Absorption ofgluw­ hione from the ganro­ intestinal cract, Biochim. BIP­ 2i 1 M. Tanaka, N. Yanagibashi, H. Fukuda and T. Nagai: Absorption of salicylic acid through the oral muco\ Lz membrane of hamster cheek pouch, Chem. Pharm. 22) M. lshida, N. Nambu and T. Nagai: Highly viscousgel ointmenr conraining carbopol for application SO thr oral mucosa, Chern. Phorm. Bull.. 31,4561 ­4564 (1983. 2 3 ) G . M. Oi'hidord R. S. Callan and H. S. Wan&: Fluoridt absorption rhrough rhe hamster cheek pouch: A pH­ dependent event. J. Appl. Toxicol.. 1,303­ 306 . (1982). ' ,741 T. Koizumi, T. Arira and K. Kakemi: Absorption and excretion of dtugs. XX. Same pharmacokinetic aspects of absorption and excretion of sulfonamides. (2). Ab­ .sorprion from rat small inrescint, Chem. Phorm. BulL.. 12,421 "427 <19& 4>. 3 1 D. W'mne: Shfi of pH­ absorption cwves. 3. Phorwce­ kine:. Bmpharn;.. 5,5.?­% (l? y­~. 26! ­l W. Bridges. ). B. Houscon. hf J. Humpheq. 'X. E Lmdup. D­ V. Parkt. J. S. Shilllngford and D. G. Fpsh­ all Gasrrointcaxnal absomtion oicarknoxolone in rht 1449­ 1651 (1980). phJ73. ACW 815,184­ 188 (1985). Bulf.. 28.1056­ 1061 (1980). 1601­ 1605 11980). IO) 1. A. Siegl. Efien oi chemical strucrae r m n; k­ iear.)­ lyre penetration of oral rnucosz. 1. fnves; lkrmnrr!.. 76, li7­­ 140( 19S1). 11) I. A. Sirgel, K. T. lmnu and E. Warson. hlcchanwns of non­ elrcrrolyre penetration across d g and rabEtlc or21 m u c w in >,. irru. Arch. OralBio1.. 26,357­ 361 (1981). 121 K. Yamaoka, Y . Tanigawara. T. Nakagaa­ a and 1. Uno: A pharmacokinetic analysis program !ML'LTlj for microcompurrr, 1. Phormacobio­ Dp.. 4, 13) T. Yamana, A . Tsuji, E. Mipamoto and 0. Kubo: Novel method for determination of parririon coeffi­ cients of penicillins and cephalosporins by high­ pressure liquid chromatography. J. Phnrm. Sri.. 66, 14) 1. A. Siege]: prrmeabiliry oirht rat ora? mucose tc; organic soIutes measured in viw. ,qr~%. Or; ' BI~, '.. 29. 15) J. M. Diamond and E. M. %'rig$: Bioio~~ ca_ l mem­ 879­ 885 (1981?. 747­ 749 (1977). 13­ 16 (I9&­ 4t. rar determined in vitro and in siru: Deriations from the p!­ l­ partitdon hypothesis. J . Pharm. Phorniawi.. 2­ b 5. Furusaaa, K. Okumura and H. Sezaki: Enhanced r n l ­ pration of the ionized forms of aci& c drugs from water into chloroform in the presence of phosphulipids. 1. Pharm. Pharmacol.. 24,272­ 276 (19721. 28) 1. Anmo, hi. Washitake, T. Kurashigt, Y. Ozawa and K. Kikuchi: Srudies on rhc absorpdon through the oral. mucous membrane. I. Absorption of salicylic acid denratiws from the rat oral mucous membrane, Yuku­ zaigoh. 28,113­ 116 (1968:. 29) A. Tsuj" E. Miyamoto, X. Hashimoto and T. Yamam. GI absxption of &laccam anniiotio II: Deviation from pH­ partition hypothesis in peniciliin absorption in sin! and in rim lipoidal barriers. J. Pharm. Sci., 67, ­ 1705­ i'll (1978). A. H. btckerr and M . f P ~c k u ~. ­4 mode1 for a r r o d rranspx acros biologics! membrznes. J. €'hum. Phar­ mco:.. 27.1116­ Lli4 Clg­ jj. 28.11" 126 (1 9'6). *' Am&. The acute oral toxicity, repellency, and m d potential of 998 chemicals to one or more of species of wild and domestic birds was deter­ mined by standardized testing procedures. Red­ .; irtg& blackbirds were the most sensitive of the bid spcies tested on a large number of chemicals, on index based on redwing toxicity and repel­ kMy may provide an appropriate indication of the probability of acute avian poisoning episodes. At­ ian repellency and toxicity were not positively conejated (Le. toxicityvariedindependently with mpetlency). In a program designed to evaluate chemicals as ptential avian toxicants. stupefacients. or repei­ knts, personnel of the Wildlife Research Center at 'Denver, Colorado have tested (since 1960) ­over ,mK, chemicals for acute oral toxicity to one or more species of wild and domestic­ birds. The pur­ p c of this paper is to summarize the data on 998 Lnown chemicals, draw appropriate generalizations fiom the data, and make recommendations on how these data might be used to predict acuteavian pisoning potentia?. Methods Thc chemicals included technical and analytical gtadc. pcstici­ &I. pharmaceutical. and other commercial or experimental compounds that were either purchased or solicited from caopcnting firms. For presentation purposes. they have been maneed according IO Chemical Abstracts Registr). Numbers CCASI. and are identified by an accepted trade. coined. produa ......... ....................... ...... ... or other chemiul name thu is a04 included in the 9th Cdkaive Index of Chemical Abstms Service. ' Wild­ trapped birds we* preconditioned to captivity for 2 IO 6 weeks and were usually dosed by gavage with solutions or IW­ pensions of the Ws! chtmiul in propylene glycol, rccordiqL IO methods d e s c n i d by Drcino et rrl. WhX). Schafer (1972,. rad Schafer e1 el. (1% 7). other on! dosing methods were OCcIJiQII­ aIfy used (pellets. whtin upsuks) but are not noted in the t. Mer (Schafer, 1972). LD, values were calculated by the metbod of Thompson (19411). Thompson and Wcil( 1952). and Weil( 1952). Repellency tests were conducted by the methods of Starr rr u/. (1960 and Schafer and Bmalon (1971). and R; s (analogous to LD, 'rt were ulcuhred either bythe method of tilchlield and Wikoxin (1949) or Thompson and Weil( l9S2). A mpeUency­ toxicity indcx (hazard factor) was plculated by assuming that at the R, kvel, J sixty­ live g male redwing watld consume 50% of Ris approximate individual maximum food a­ parit! of 1 g B> m a h p 'this assumption. i: was possibk to estim, It the mg Lg of a chrrnlsal that could concctuabl! k in­ . gested by a, redwing tl a given Rm kvcl. This value. when divided by the acute oral LD, p~ ovides an index for indicating bow likely it would be for acme onl poisoning lo occur in tbc wild. An index value > I .W indicates weil­ accepted toxic agents that have definire potentid for causing acute poisoning eplsodes. an iadcx value a0.25 61­ 00 indmtes these compounds witb a p s i ­ Me gkxentiP1. and an indu nlw ~0.25 indicates thoK compounds with little Of no .potentid Io cause acute avian poisoning cpiwdes.­ at kast io redwiap. Because of :be hrpc .mourn of data accumuhted. an atrcmpt was made to determine &e signiicance of andlor comltlion bets­ een the tu0 of Ihe measured parameters. Statistical com­ parisons of specks xns* iities and ranked data were made by Friedmans ranking procedure (Friedman 1937) and ANOVA folloked by Duncans Myiiipk Range Test. Although thc clan­ parametric' 'Fricdrmns pdedure is a more accurate and d i d * Because of the kngrb and complexity of chemical abstracts nomenclature. the names used lo identify chemicals in fa& 2 . were extracted from several sources. Primary consideration was given lo the common name. but shortened chemical names. code numbers. or registered uademarks were also used but may not be specifically identified ...... ." ....... ". Results The 68 bird species tested, along with their cur­ . rently ­acceptedscientificnames and a four letter species code that was used in the following tabular data, are detailed in Table 1. Table 2 presents a tabular listing of the acute oral toxicity (LD, J of the 998 chemicals to one or more of three avian species (redwing, starling. coturnix) plus :he avian repel­ lency values (R,) and the toxicity­ repellency index for redwings. Redwing, starling, and coturnix data were analyzed for those cases where LD,* s (other than c or values) wereavailable for all these species (n = 73) or for redwings and starlings along (n = 130). It was shown that redwings were sig­ nificantly more sensitive than starlings (p = 0.001). and that starlings and coturnix were not different ' (p = 0.05). Thedifferenceintoxicological sensi­ tivity between redwings and starlings was 2. Ix and the difference between coturnix and redwings was 1.4~. This agrees with previously published obser­ ' vations of therelativesensitivity relationships of redwings compared to other wild and domestic avian species (Schafer 1972; Schafer t r 01. 1979). ~ Statistical comparisons of the correlation be­ tween redwing LDds and R, 's were made to de­ termine the validity of observations made over the past 20 years indicating that avian repellent activity appears IO increase with increasing acute oral tox­ icity. Ofthe 998 chemicals tested, redwing R, 's and LI), 's. are presented for 836. Qf the 836, Rw and LDs values for 501 chemicals (60.0%) were both greater than selected minimum activity levels (F. 0095 for R, and 100 m g Q or (90 mglkg) for LD& 84 (IO. 1%) were repellent at or below 1 .WC but toxic above I 0 0 m a g , 75 (8.9%) were toxic at or below 100 m a g but repellent above 1.00%. 41 (4.9%) were not usable and 135 (16.2%) possessed activity in the range (R, 1.00% LDSO sz 100 hglkg) that could be used lo examine the ;elmti* ship between these two facton. However, n e i h Parson or Spearmancorrelationcoefficients (0.33 ­ and 0.43, respectively) showredmy positive corn . lation between R,* r and LD?, 's. Thus, the dab . dicatethat gross acute toxiaty, as defined by ­_ LD, is not positively related to gross as defined by the RY,. at least over the small nqe examined. The repellencyftoxicity index or acute avipp hazard index was calculated for 377 cbemicdr I where one or both R, and LD, values were knom. :. Those chemicals for which the LD, and R, wen only known to exceed some value could not be u~ in subsequent calculations since no meaningful value or trend could be determined by the index. 01 the 223 chemicals for which definite index v d u a could be calculated, 124 fell into the > 1 .@ I class, 47 ­ intothe 20.25 d 1.00 class and 52 intbe ~0 .3 ­ class. Examples of some chemicals in tbe >]. a ­ class (hazardous) are: Mitomycin C. TEM, thiotepa, famphos, parathion, and dimethoate. Examplesof chemicals in the possibly hazard­ '­. class (30.25 6 1 .OO) are: coumaphos, aprocarb, feb sulfothion, fenitrothion, and malathion. Exampla .; ._ of chemicals that fall into the probably nom­ hazardous class (~ 0.25) are: lidane, sulphenone, chlorpropham. thiram, and chlorothion. This index appears to have great potential for predicting those chemicalsthatmay cause acute avian poisoning episodes in thefield. It is the first time, to ow knowledge, that an attempt has been made to J equate potential hazards to an index that combiner the toxicity of a compound with a behavioral mea­ sure that predicts how. much of the chemical could porentially be consumed in a fieldsituation. Thus, 1 fieldapplicationof a highlytoxicchemicalthat is ' ­' aversive to birds could have the same or less likeli hoodofinducing acute avianpoisoning as a less 5 toxic chemical that was more readily accepted. Table 3 presents acute oral toxicity data of 82 . chemicals to one or more of seven additional avian species. Table 4 presents the acute oral toxicity and repellency data of 90 chemicals to one or more of 58 other species of birds. * ~a b k ­1. Species code. common. tad scientific names of birds referred 10 in this paper Species code Common name Scientific name d e s American kestrel (F u h spon­ crius) bbv Blue­ black grassquit (Vdariajucorinu) bbmP Black­ bt& d magpie (Pica picu ) bhcb Brown­ headed cowbird (Afoforbrus urcr) bjay Blue jay (C. vunocirru rristaru) brcb Bronzed cowbird (fongm­ ius urnrus) bowl Barn owl (T ~I u o h ) I ! i .. . ", . i­>­.­. i7 ..:. . . ­ ,... ­, .. .. . . . , , . . . . . .. . . . . " . Brown thnshcr Bat­ taikd qackk Brown­ throated conure Budgerigar Common bobwhite Bluc­ winged leal Curve­ billed ihnsher Ameriun crow Cassins finch Canada goose Common grackle Plain chichalam Cooper's hawk Cownix Rock dove or common pigeon Norihern raven Cedar wuwin5 Dickcissel Eared dove Goldensrowned spamow Common or pound dove Golden cagk Cddea spamow Green jay House finch Homed lnrk HOUK spurow l n u dove LprL bunting Mallard Mourning dokc Nonhem bvrier (Marsh hawk) Monk parakeet Sonhern masked weaver Orurge­ fronted conure Common pintail Red bishop Ring­ billed gull Ruddy­ breasted seedeater Red­ cycd cowbird Ruddy pound dove Ripg­ wkd ph­ t AmcTiunrobin Red­ winged blackbird Scrub p y scpty dove Shinycowbi Sandhill crane European starling Swainson's hawk Tricolored blackbird Wild turkey California qurj . Wage weaver Whitt­ crowncd sparrow White­ fronted dove Yellow­ beaded blackbid .YeUow­ billed maspie Red­ baed qWlU . . White­ wing4 dove 1 E. W. Schlct. Jr., d. 8 \ ! Y Ci V g K d . #I .. .~. ... .. i ­ Y r ++ ++ ...... ........... i :. .... ."~ ......... .­,._ : ..................... .. .­ ....................................... M2 E. W. Schrlct, kr., 1 +++1 ++ I .. .. .... ........ .. .. ........... .. .­ I +++ ­. .. I . i .. i ­* .a 2 , i : i : P E. W. Schrfcr. Jr.. et d. 369 I 1 1 1 1 l l l l l W" ". ." ­ .. 37 I Q 0 8 0 + I ++ I +.I ++ I ?++++ + +I ++ ++ + + +I +++ ++I ++ I + + 1 1 372 = ­ E 3 II ci Y F l + I I U n a I I +++ ++ 3 s 0 I I I +* =s I I f *++ + + + +. + ++ ++ + 1 1 . I 374 1 I I i I 2 ,... ­. .'.. .._".., ~ ;, . . ­. 1 ., .. ..... ~..~­. .. ., .., . . , , . . . . . .. ­ .. . . . . . ~ . . . ... . . ­ .,." ~ ..._.. ,.... . . ., . . . . . .­ , ­ . . . .. .". 375 4 I I n I I I +I I I I +' ++ + I I + +I I +l t l 1 1 1 +1 1 e?, 'p! on a ir z 0 " 8$ m ­ i c: 2% n I + +I + 8 ......... ­ ......... . il_ ......... ~"~,,~..~~"~.~~~."~­~~~­~' 1 L,,. ... i . .. ......... ... ... .. ......... , .. ........................ ..... ........ ............................. ..... :­... ... , .: , . .. ... ........ _._ __ f I I I I I i i ... . ..; i I I I i 5 t I ~ 8 a a .I i i .E i r i l l 3 0 f y 0 r i 1 ++ ++ I ++ 1 . .. . L 2 . .­ . .. . . .~.. . ._ .. . . . . .. .. ... ?... .. . . . . . . . . . . .. : . . .. .. . ­1 . .. ?L ..... ­~, . .. ii........... ....= ............ I i I I a I ' f ­1 tC B ' .. ­. .... ~. A i Arknn*./ rd~ mrats. fhc ruthors wish lo thank the following i d ­ viduak for astktunce in colkcting. typin;. and editing the data contained in this puhlicarion; Trudic Abendroth. Lore Burbach. Donald Cunningham. Patrick Fundetbuq. J a ~t Garcia. Thomas Hall, hvid Hayes. Glenn Hood. Ccccli. Nelson. and Barbara Recktenwald. The preparation md compbtion of this data was supported. in pan. throughInteragencyAgreement Ill­ 16 Oooy­ 81.957 whichwasfundedbythe U. S. Environmental he tection Agency. References DcCino. T. 1.. D. J. Cunningham. m d E. W. Schafer: Toxicity of DRC­ 1339 to starlings. J. Wildl. Manage. 30, 249 (1%). Fnnk. F. R.. E. W. Schafer, Jr.. and J. L. Guuino: Labontory and field studies with an avian rcpcnent lor sprouting seeds. hoc. Bird Control Seminar S, 86 (1970). Friedman. M.: The use of ranks lo avoid the assumption of nor­ malityimplicit in. the analysis of variance. J. Amer. Stat. ASUK. 32,675 (19371. Litchfiild. J. T,, and E. W. Wilcoxon: A simplified method of evaluatingdose­ effectexperiments. I. Pharmscol. Expli. Thcnp. 96, 99 1949. Schafer, E. W., Jr.: The acute o d toxicity of 369 pesticidal. pharmaceutical and other chemicals to wild birds. Toxicol. Appl. Phannacol. 21,315 (1972). Schafer. E. W.. Jr.. and R. B. Brunton: Chemicals as bird rcpeE lents­ two promising agents. 1. Wddl. Manage. 35. 549 Cm! d md Mrn. gemen1 MltCrirtS. ASfM !iTP dfft J. Beck fed.). Americrn Sosicty for Testing a d Mater$&, 157. Phihdclphia, PA (19791. Schafer. E. W. Jr.. 1. L. Gutwino. md R. 8. Brunton: Use d rmlc cotumix quail in the lahorntory development d rviu\ chcmoctcrilants. Vertebrate Pest Contd md Manycmnt Materials. ASTM STP 625 W. 8. Jackson and R. E. Marsh . (cds.). American Society for Testingand Materials. t2J. Philadelphia. PA (1977,. Schafer. E. W.. It., R. R., West. rnd D. 1. Cunningham: DRC­ 1347­ A new starling contact toxicant. Pest Conlroln, 22 (1 9 6 9 t . Schafer. E. W., Jr.. R. B. Brunton. N. F. Lockyer, urd J. W. IkGmio: Comparative .toxicity of 17 pesticides IO c& qwlu. house sparrow and red­ winped blackbird. 'Toxicol. A d . Phmacol. 21, 154 (1973b). Schafer. E. W. Jr.. R. 8. Brunton, E. C. Schafer, andJ. chcvct: ufects of 77 chemicals on reproduction in mak and f e w e coturnix quail. Ecotoxicol. Environm. Safety 6* 149( 19Q. Schafer. E. W., Jr.. R. 1. Stur, D. 1. Cunningham. and T. 1. DcCino: Substituted phenyl N­ mcthylurbomrtes as temp ruy immobilizing agents T o t birds. 1. A&. Food Chcm. U, & trwn. Sheftc, N.. R. L. Bruggerr, ind E. W. Scbafer, Ir.: RepcaaCy md toxicity of three bird control chemicals to four spctiet d Atriun prin­ cating biids. J. Wild. Manige. 41.43 (19M). Sncdec0r. G. W., and W. G. Cocbmn: Statistical methods. 6cd. Iowa State UNv. Rets A m . Iowa: (1971). Stan. R. I.. 1. f. Besser. and R. 8. Brunton: A labontm ( 1971 1. method for evaluating chemicals as bird repellents. J. &. Schafer. E. W.. Jr.. and D. 1. Cunningham: An evaluation of I 4 6 compounds as avian immobilizing agents. USDl Spec. ki. Rept. Wildl. 150. Washington. DC (19721­ Schafer. E. W., Jr., R. 8. Bnmton, lad D. J. Cunningham: A summary of the acute toxicity of Cminopyridine 10 birds and mammals. Toxicol Appl. Ph~ rmcol. 26. 532 (1973a). Schafcr, E. W.. Jr.. R. 8. Brunton. and N. F. lockycr: Evaluation of 45 c h c m d s as chemo\ tcnlanls in aduk male coturnix. J. Reprod. Fen. 48, 371 (1976). &haler. E. W.. Jr.. R. B. Brunton. a@ N. F. tockyrr: Indt cator bird species for toxicity determinations: Is the tech­ nique useful in test method development? Vertebrate Pest FOO~ a m . 12,342( 1964). Thompson. W. R.: Use of moving avemges and interpolation to estimate median effective dose. Bacteriol. Rev. 11, 115 (19481. Ihompson. W. R.. and c. S. We& On the constructjon of Wa for moving avemge interpolation. Biometrics 8, SI (1952). Weil. C. S.: Tables for convenient ulcuiation of mediancffec­ liw dcwt tLD5.. or ED, * andinstructions in the:: use. B~ omclncs 8.24Y (19521. ­ ­­ Manuscript receiwd for publication Juk IO. lW2 and in revised form Nownbcr 1.1982. . .. f V ' cn w a U 8 W E (1 N el z c u 3 a c 0 z I­ : c? s 4 ar! 0 + 'c. 3 8 cj ­0 C 0 11 t, c 8 ' c " 5 0 I v) w ­E i z c NN 1 ::: " ' 4 , . Y . . , . . ­ . . . . ­., . ._: . .. .. . . ,. . , .,. . . 19. O­ TOlu~ d~ fl~. 5­ nltr0­ .9 " C& l& Oa ll2.15 1.88 . ­ 2 14 2.35392 343 0.07 5 A3778 w 3389 22. AniliM. 1~&* 7 %H,, N% lQ. l& 1.11 ­ 4.26 ­ 1218 128 64.6 5 A331 2. JdinWmow­. W 1490 rf f . . ­. ­ ., ­. .. ~. ....... , ­ . ...,, .. .~ . .. . . , . ., .. . . . . ~ .. ,.. 8" v 0 ­ s GQ a e b, ' _ b . I W a a 0' 5 . .. h (Y t v) w r z d < c ). i 0 X : a 0 3 X + 1+ # Ti! c s= ." a 4 I ... ... i < c W W 3 0 W z Q x ... ... ­. , . .. I Q W 3 a 2 Y ,, ' '.. .. m C ­ 0 a ­ f P f n g . > 2 c ri > > d J 3 a ui

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Notice

Pesticide Product; Registration Approval

[ Federal Register: June 11, 2002 ( Volume 67, Number 112)] [ Notices] [ Page 39978­ 39979] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr11jn02­ 68] [ Federal Register: June 12, 2002 ( Volume 67, Number 113)] [ Notices] [ Page 40291­ 40292] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr12jn02­ 69] [[ Page 40291]] ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ENVIRONMENTAL PROTECTION AGENCY [ OPP­ 2002­ 0006; FRL­ 6833­ 2] Pesticide Product; Registration Approval AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ SUMMARY: This notice announces Agency approval of applications to register the pesticide products LPE E94T and LPE­ 94 10% Aqueous containing an active ingredient not included in any previously registered product pursuant to the provisions of section 3( c)( 5) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), as amended. FOR FURTHER INFORMATION CONTACT: Carol E. Frazer, Biopesticides and Pollution Prevention Division ( 7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 308­ 8810; e­ mail address: frazer. carol@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Examples of Categories NAICS codes potentially affected entities ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of This Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select Laws and Regulations,'' Regulations and Proposed Rules,'' and then look up the entry for this document under the Federal Register­­ Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. To access a fact sheet which provides more detail on this registration, go to the Home Page for the Office of Pesticide Programs at http:// www. epa. gov/ pesticides/, and select fact sheet.'' 2. In person. The Agency has established an official record for this action under docket control number OPP­ 2002­ 0006. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305­ 5805. In accordance with section 3( c)( 2) of FIFRA, a copy of the approved label, the list of data references, the data and other scientific information used to support registration, except for material specifically protected by section 10 of FIFRA, are also available for public inspection. Requests for data must be made in accordance with the provisions of the Freedom of Information Act and must be addressed to the Freedom of Information Office ( A­ 101), 1200 Pennsylvania Ave., NW., Washington, DC 20460. The request should: Identify the product name and registration number and specify the data or information desired. A paper copy of the fact sheet, which provides more detail on this registration, may be obtained from the National Technical Information Service ( NTIS), 5285 Port Royal Road, Springfield, VA 22161. II. Did EPA Approve the Application? The Agency approved the applications after considering all required data on risks associated with the proposed use of lysophosphatidylethanolamine ( LPE), and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency has considered the nature of the chemical and its pattern of use, application methods and rates, and level and extent of potential exposure. Based on these reviews, the Agency was able to make basic health and safety determinations which show that use of LPE when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects to the environment. III. Approved Applications EPA issued a notice, published in the Federal Register of September 19, 2001 ( 66 FR 48256) ( FRL­ 6791­ 1), which announced that J P BioRegulators, Inc., Suite 125, 3230 Deming Way, Middleton, WI 53562 ( now called Nutra­ Park Inc., 8383 Greenway Blvd., Suite 520, Middleton, WI 53562, had submitted applications to register the pesticide products LPE E94T ( EPA File Symbol 70515­ E) and LPE­ 94 20% Aqueous ( EPA File Symbol 70515­ R) containing 94% and 20% lysophosphatidylethanolamine, respectively. The registrant subsequently submitted a lower concentration formulation with 10% LPE and 90% other ingredients for 70515­ R. These products were not previously registered. The applications listed below were approved on March 26, 2002 for these growth regulator products containing 94% and 10% LPE and 6% and 90% other ingredients respectively: 1. LPE E94T ( EPA Registration Number 70515­ 2) for manufacturing use only product. 2. LPE­ 94 10% Aqueous ( EPA Registration Number 70515­ 1) for enhancing product ripening in the field and increasing shelf life of fruits, flowers and vegetables, an end­ use product from the above manufacturing use only product. [[ Page 40292]] List of Subjects Environmental protection, Chemicals, Pesticides and pests. Dated: May 21, 2002. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. [ FR Doc. 02­ 14493 Filed 6­ 11­ 02; 8: 45 am] BILLING CODE 6560­ 50­ S ===================================================================== == ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ENVIRONMENTAL PROTECTION AGENCY [ OPP­ 2002­ 0104; FRL­ 7182­ 7] Industrial Economics Inc.; Transfer of Data AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ SUMMARY: This notice announces that pesticide related information submitted to EPA's Office of Pesticide Programs ( OPP) pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) and the Federal Food, Drug, and Cosmetic Act ( FFDCA), including [[ Page 39979]] information that may have been claimed as Confidential Business Information ( CBI) by the submitter, will be transferred to Industrial Economics Inc. in accordance with 40 CFR 2.307( h)( 3) and 2.308( i)( 2). Industrial Economics Inc. has been awarded multiple contracts to perform work for OPP, and access to this information will enable Industrial Economics Inc. to fulfill the obligations of the contract. DATES: Industrial Economics Inc. will be given access to this information on or before June 17, 2002. FOR FURTHER INFORMATION CONTACT: By mail: Erik R. Johnson, FIFRA Security Officer, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 305­ 7248; e­ mail address: johnson. erik@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action applies to the public in general. As such, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select Laws and Regulations,'' Regulations and Proposed Rules,'' and then look up the entry for this document under the Federal Register­­ Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. II. Contractor Requirements Under contract number GS­ 10F­ 0224J, the contractor will perform the following: EPA's Office of Enforcement and Compliance Assurance ( OECA) is responsible for providing assistance to enforcement professionals from EPA and the States in determining: ( 1) A violator's economic benefit of noncompliance; ( 2) the violator's ability to pay for compliance, clean­ ups and civil penalties ( hereinafter referred to as ability to pay''); ( 3) the value of a supplemental environmental project ( SEP); and ( 4) the value of compliance. This assistance is largely provided through five current computer models: Ben, Abel, Indipay, Munipay and Project. Ben calculates a violator's economic savings from violating the law. Abel, Indipay, and Munipay evaluate claims of inability to pay from for­ profit entities, individuals and municipalities, respectively. Project calculates the net­ present, after­ tax value of a proposed supplemental environmental project. OECA also provides support in these areas through the use of expert financial consultants where the models are insufficient. OECA must keep its models up to date, provide educational programs to ensure proper application of the models, support negotiations, trials and hearings, and provide advice to our enforcement professionals as to issues that arise in using the models. Since there are very few corporate finance, municipal finance, or accounting experts within OECA, the contractor shall provide that expertise and update the models, develop new models as appropriate and educate enforcement staff on the models. The contractor shall also provide expert advice to enforcement personnel regarding financial issues that impact enforcement litigation, and when directed, support enforcement negotiations, and appear as expert witnesses in hearings and trials. However, EPA employees will make all policy decisions in regard to finance/ accounting issues. To the extent that the work under this contract requires access to proprietary or confidential business or financial data of other companies, and as long as, such data remains proprietary or confidential, the contractor shall protect such data from unauthorized use and disclosure. All files or other information identified as CBI shall be treated as confidential and kept in a secure area with access limited to only contractor personnel directly involved in the case or special project assignment. The contractor, subcontractor, and consultant personnel are bound by the requirements and sanctions contained in their contracts with EPA and in EPA's confidentiality regulations found at 40 CFR part 2, subpart B. The contractor, subcontractors, and consultant must adhere to EPA­ approved security plans which describe procedures to protect CBI, and are required to sign non­ disclosure agreements before gaining access to CBI. All official data, findings, and results of investigations and studies completed by the contractor shall be available for EPA and Department of Justice internal use only. The contractor shall not release any part of such data without the written direction of the project officer. This contract involves no subcontractors. OPP has determined that the contracts described in this document involve work that is being conducted in connection with FIFRA, in that pesticide chemicals will be the subject of certain evaluations to be made under this contract. These evaluations may be used in subsequent regulatory decisions under FIFRA. Some of this information may be entitled to confidential treatment. The information has been submitted to EPA under sections 3, 4, 6, and 7 of FIFRA and under sections 408 and 409 of FFDCA. In accordance with the requirements of 40 CFR 2.307( h)( 3), the contract with Industrial Economics Inc., prohibits use of the information for any purpose not specified in these contracts; prohibits disclosure of the information to a third party without prior written approval from the Agency; and requires that each official and employee of the contractor sign an agreement to protect the information from unauthorized release and to handle it in accordance with the FIFRA Information Security Manual. In addition, Industrial Economics Inc. is required to submit for EPA approval a security plan under which any CBI will be secured and protected against unauthorized release or compromise. No information will be provided to Industrial Economics Inc. until the requirements in this document have been fully satisfied. Records of information provided to Industrial Economics Inc. will be maintained by EPA Project Officers for these contracts. All information supplied to Industrial Economics Inc. by EPA for use in connection with these contracts will be returned to EPA when Industrial Economics Inc. has completed its work. List of Subjects Environmental protection, Business and industry, Government contracts, Government property, Security measures. Dated: June 3, 2002. Linda Vlier Moos, Acting Director, Information Resources and Services Division, Office of Pesticide Programs. [ FR Doc. 02­ 14635 Filed 6­ 10­ 02; 8: 45 am] BILLING CODE 6560­ 50­ S

epa

2024-06-07T20:31:41.479225

regulations

EPA-HQ-OPP-2002-0009-0001

Notice

Availability of Reregistration Eligibility Decision Document for Comment

Availability of Reregistration Eligibility Decision Document for Comment [ Federal Register: April 18, 2002 ( Volume 67, Number 75)] [ Notices] [ Page 19178­ 19180] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr18ap02­ 54] ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ENVIRONMENTAL PROTECTION AGENCY [ OPP­ 2002­ 0009; FRL­ 6832­ 6] Availability of Reregistration Eligibility Decision Document for Comment AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ SUMMARY: This notice announces availability and starts a 60­ day public comment period on the Reregistration Eligibility Decision ( RED) document for the pesticide active ingredient propargite. The RED represents EPA's formal regulatory assessment of the health and environmental data base of the subject chemical and presents the Agency's determination regarding which pesticidal uses are eligible for reregistration. DATES: Comments, identified by docket control number OPP­ 2002­ 0009, must be received on or before June 17, 2002. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP­ 2002­ 0009 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: Dayton Eckerson, Special Review and Reregistration Division ( 7508W), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 308­ 8038; and e­ mail address: eckerson. dayton@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. This action may, however, be of interest to persons who are or may be required to conduct testing of chemical substances under the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) or the Federal Food, Drug, and Cosmetic Act ( FFDCA); environmental, human health, and agricultural advocates; pesticides users; and members of the public interested in the use of pesticides. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select Laws and Regulations,'' Regulations and Proposed Rules,'' and then look up the entry for this document under the Federal Register­­ Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. To access RED documents and RED fact sheets electronically, go directly to the REDs table on the EPA Office of Pesticide Programs Home Page, at http:// www. epa. gov/ pesticides/ reregistration/ status. htm. 2. In person. The Agency has established an official record for this [[ Page 19179]] action under docket control number OPP­ 2002­ 0009. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305­ 5805. C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP­ 2002­ 0009 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305­ 5805. 3. Electronically. You may submit your comments electronically by e­ mail to: opp­ docket@ epa. gov, or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in WordPerfect 6.1/ 8.0/ 9.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP­ 2002­ 0009. Electronic comments may also be filed online at many Federal Depository Libraries. D. How Should I Handle CBI That I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the notice or collection activity. 7. Make sure to submit your comments by the deadline in this document. 8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. Background A. What Action is the Agency Taking? The Agency has issued a RED for the pesticide active ingredient listed in this document. Under the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), as amended in 1988, EPA is conducting an accelerated reregistration program to reevaluate existing pesticides to make sure they meet current scientific and regulatory standards. The data base to support the reregistration of the chemical listed in this document is substantially complete, and the pesticide's risks have been mitigated so that it will not pose unreasonable risks to people or the environment when used according to its approved labeling. In addition, EPA is reevaluating existing pesticides and reassessing tolerances under the Food Quality Protection Act ( FQPA) of 1996. The pesticide included in this notice also has been found to meet the FQPA safety standard. All registrants of pesticide products containing the active ingredient listed in this document have been sent the appropriate RED, and must respond to labeling requirements and product­ specific data requirements ( if applicable) within 8 months of receipt. Products also containing other pesticide active ingredients will not be reregistered until those other active ingredients are determined to be eligible for reregistration. The reregistration program is being conducted under Congressionally­ mandated time frames, and EPA recognizes both the need to make timely reregistration decisions and to involve the public. Therefore, EPA is generally issuing these REDs as final documents with a 60­ day comment period. Although the 60­ day public comment period does not affect the registrant's response due date, it is intended to provide an opportunity for public input and a mechanism for initiating any necessary amendments to the REDs. All comments will be carefully considered by the Agency. If any comment significantly affects a RED, EPA will amend the RED by publishing a description of the amendment in the Federal Register. EPA is particularly interested in receiving comments on the practicality of the revised restricted entry intervals ( REIs) contained in the RED. ( The REI is the period of time following a pesticide application during which EPA restricts worker entry into a treated area to mitigate risks posed by pesticide residues. Once the REI expires, EPA believes residues have declined to a point where they pose negligible risks to workers). As noted in the RED, the Agency typically structures its REI label requirements so that a single REI will apply to all post­ application activities for a given crop or crop group. In other words, even if management of a given crop requires multiple post­ application activities, the Agency will establish a single REI for all those activities even if [[ Page 19180]] those activities involve different exposure potentials. To ensure that workers are adequately protected, that one REI will usually be based on the activity that involves the highest level of exposure. This approach is favored because users and employers are more likely to understand and comply with clear labels. Also, establishing multiple activity­ based REIs for crops could cause confusion and compromise compliance with and enforcement of worker protection regulations. However, when the consideration of risks and benefits indicate that a single REI is unworkable, EPA will consider granting exceptions. For most propargite uses, a single crop­ specific REI is being proposed in the RED because no critical activity was identified that warranted establishing an exception. During the 60­ day comment period for this RED, however, EPA will accept further comments from growers regarding needs for additional REI exceptions for specific post­ application activities, and will add such exceptions where needed if there are adequate margins of exposure ( MOEs) and/ or benefits associated with such activities warrant such an exception. To assist the Agency in making its risk/ benefit finding on a specific exception request, the following benefits­ related information is most useful. 1. Identify the crop( s) and provide a description of the specific production task( s) for which the exception is requested. Explain why the task is critical during the REI. As specifically as possible, describe how the task is performed including timing within the growing season, equipment and/ or PPE used in performing the task, nature of the contact with treated surfaces, and duration for performing the task including the number of hours per days and number of days. 2. Explain why the critical tasks cannot be performed prior to application or after the REI has expired. Include detailed information on the critical pest( s), the timing of the application, and the impact of modifying the pesticide application to conform to the REI. 3. Describe the geographic area for which the exception or prohibition is requested. If the exception request is limited to a specific geographic area, describe why the circumstances of exposure or economic impact resulting from the prohibition of routine hand tasks during the REI are unique to the geographic area named in the exception. 4. Explain, for each requested crop/ task combination, why alternative practices would not be technically or financially viable. Such alternative practices might include rescheduling the pesticide application or hand labor activity; using non­ chemical pest control alternatives; using an alternative to hand labor tasks, such as machine cultivation; or substituting a pesticide with a shorter REI. This information should include estimates or data on per acre revenue, and cost of production for the crop area for which the exception is requested. These estimates or data should include: The current situation, the situation if the exception is not granted, the situation if the exception is granted, and specific information on the individual factors which cause differences in revenues and cost among the three situations. 5. Provide documentation or a description of the safety and feasibility of such an exception, including, but not limited to, the period of time required daily per worker to perform the hand labor activity, any suggested methods of reducing the worker's exposure, and any other mitigating factors, such as the availability of mechanical devices that would reduce the workers' contact with the treated surfaces. B. What is the Agency's Authority for Taking this Action? The legal authority for this RED falls under FIFRA, as amended in 1988 and 1996. Section 4( g)( 2)( A) of FIFRA directs that, after submission of all data concerning a pesticide active ingredient, the Administrator shall determine whether pesticides containing such active ingredient are eligible for reregistration,'' before calling in product­ specific data on individual end­ use products, and either reregistering products or taking other appropriate regulatory action.'' List of Subjects Environmental protection. Dated: April 5, 2002. Lois Rossi, Director, Special Review and Reregistration Division, Office of Pesticide Programs. [ FR Doc. 02­ 9501 Filed 4­ 17­ 02 8: 45 am] BILLING CODE 6560­ 50­ S

epa

2024-06-07T20:31:41.483406

regulations

EPA-HQ-OPP-2002-0023-0001

Notice

Dimethoate Product Cancellation Order and Label Amendment; Technical Correction

21669 Federal Register / Vol. 67, No. 84 / Wednesday, May 1, 2002 / Notices Subpart B Criteria is approximately 11,000 hours per year, with a current annual cost of $ 393,000. The current estimated number of respondents is 164 with a current average annual burden of approximately 67 hours per respondent. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Dated: April 23, 2002. Matthew Hale, Acting Office Director, Office of Solid Waste. [ FR Doc. 02 10734 Filed 4 30 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0023; FRL 6834 4] Dimethoate Product Cancellation Order and Label Amendment; Technical Correction AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice; technical correction. SUMMARY: EPA issued a cancellation order in the Federal Register of March 13, 2002 eliminating the residential uses for Dimethoate. This document is being issued to correct the existing stocks provisions of this cancellation order. DATES: The cancellations became effective March 13, 2002. FOR FURTHER INFORMATION CONTACT: By mail: Patrick Dobak, Special Review and Reregistration Division ( 7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 703 308 8180; email address: dobak. pat@ epa. gov. SUPPLEMENTARY INFORMATION: I. Does this Action Apply to Me? The Agency included in the cancellation order a list of those who may be potentially affected by this action. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. II. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov. To access this document, go to the Federal Register listings at http:// www. epa. gov/ fedrgstr. 2. In person. The Agency has established an official record for this action under docket control number OPP 2002 0023. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805. III. What Does this Technical Correction Do? The cancellation order for uses of pesticide products containing Dimethoate on various commodities was published in the Federal Register on March 13, 2002 ( 67 FR 11330) ( FRL 6828 1). The existing stocks language in Unit IV is not consistent with the proposed existing stocks provisions included in the January 10, 2002 proposed Cancellation Order. The following Unit IV replaces Unit IV of the Cancellation Order published on March 13, 2002. The replacement language is consistent with the language in the January 10, 2002 proposed cancellation order. No comments were received by the Agency. The revised existing stocks provisions are as follows: IV. Existing Stocks Provisions 1. Distribution or sale of products by the registrant bearing instructions for use on houseflies and non­ agricultural use sites. The distribution or sale of existing stocks by the registrant of any product listed in Table 1 or 2 that bears instructions for any use identified in List 1, will not be lawful under FIFRA 1 year after the effective date of the cancellation order, except for the purposes of shipping such stocks for export consistent with section 17 of FIFRA or for proper disposal. 2. Distribution, sale, or use of products by persons other than the registrant bearing instructions for use on houseflies and non­ agricultural use sites. Persons other than the registrant may continue to sell or distribute the existing stocks of any product listed in Table 1 or 2 that bears instructions for any of the uses identified in List 1 after the effective date of the cancellation order and may continue until such stocks are exhausted. The use of existing stocks by persons other than the registrant of any product listed in Table 1 or 2 that bears instructions for any uses identified in List 1 may continue until such stocks are exhausted. List of Subjects Environmental protection, Pesticides, Use cancellation order. Dated: April 23, 2002. Lois A. Rossi, Director, Special Review and Reregistration Division. [ FR Doc. 02 10735 Filed 4 30 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0020; FRL 6834 3] Pesticide Product; Registration Application; Extension of Comment Period AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces an extension of the comment period regarding receipt of an application to register a pesticide product containing a new active ingredient not included in any previously registered products pursuant to the provisions of section 3( c)( 4) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), as amended. DATES: Written comments, identified by the docket control number OPP VerDate 11< MAY> 2000 23: 17 Apr 30, 2002 Jkt 197001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 01MYN1. SGM pfrm01 PsN: 01MYN1

epa

2024-06-07T20:31:41.487651

regulations

EPA-HQ-OPP-2002-0025-0001

Notice

Chlorpyrifos-methyl; Receipt of Request for Registration Cancellation

[ Federal Register: April 24, 2002 ( Volume 67, Number 79)] [ Notices] [ Page 20118­ 20121] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr24ap02­ 94] ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ENVIRONMENTAL PROTECTION AGENCY [ OPP­ 2002­ 0025; FRL­ 6773­ 1] Chlorpyrifos­ methyl; Receipt of Request for Registration Cancellation AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ SUMMARY: In accordance with section 6( f)( 1) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), as amended, EPA is issuing a notice of receipt of request by Dow [[ Page 20119]] AgroSciences LLC, and Gustafson LLC to voluntarily cancel certain pesticide registrations of products containing the active ingredient chlorpyrifos­ methyl. The voluntary cancellations were received from Dow AgroSciences LLC on January 31, 2001 and Gustafson LLC on February 13, 2001. EPA will decide whether to approve the request after consideration of public comments. DATES: Comments on the requested cancellation of product and use registrations must be submitted to the address provided below by May 24, 2002. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP­ 2002­ 0025 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: Jacqueline Mosby, Special Review and Reregistration Division ( 7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 305­ 6792; e­ mail address: mosby. jackie@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. Although this action may be of particular interest to persons who produce or use pesticides, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the information in this notice, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select Laws and Regulations'' and then look up the entry for this document under the Federal Register­­ Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. 2. In person. The Agency has established an official record for this action under docket control number OPP­ 66284. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305­ 5805. C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP­ 66284 in the subject line on the first page of your response. 1. Electronically. You may submit your comments electronically by e­ mail to: opp­ docket@ epa. gov, or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in WordPerfect 6.1/ 8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP­ 66284. Electronic comments may also be filed online at many Federal Depository Libraries. 2. By mail. Submit your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 3. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305­ 5805. D. How Should I Handle CBI that I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the notice or collection activity. 7. Make sure to submit your comments by the deadline in this notice. 8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. What Action is the Agency Taking? A. Background EPA is publishing this notice in response to registrants' requests to cancel three pesticide products containing chlorpyrifos­ methyl. ( See the [[ Page 20120]] table below for specific information regarding the cancellation requests). Reregistration Eligibility Decision ( RED) documents summarize the findings of EPA's reregistration process for individual chemical cases, and reflect the Agency's decision on risk assessment and risk management for uses of individual pesticides. Chlorpyrifos­ methyl belongs to a group of pesticides known as organophosphates ( OPs). EPA has issued a Report on FQPA Tolerance Reassessment Progress and Risk Management Decision ( TRED) assessing the risks of exposure from chlorpyrifos­ methyl. EPA will also consider the cumulative risks from all organophosphates, as they all share a common mechanism of toxicity affecting the nervous system by inhibiting cholinesterase. In letters received by EPA on January 31, 2001 and February 13, 2001, the registrants of products containing chlorpyrifos­ methyl agreed to several voluntary measures to cancel all products with this active ingredient. The registrants are requesting cancellation of these products after determining that they would not be generating or submitting data required by EPA under section 3( c)( 2)( B) of FIFRA to support continued registration of chlorpyrifos methyl products. As part of the Agreement, the signatory, and non­ signatory registrants, among other things, agreed to cancel their manufacturing use product ( EPA Reg. No. 62719­ 42) and the liquid formulations ( EPA Reg. No. 7501­ 41 and 62719­ 43) and will not sell nor distribute the products after December 31, 2003. All sales, distribution, and use of existing stocks of the manufacturing use product and liquid formulations will be allowed until December 31, 2004. EPA will consider any comments received within 180 days of publication of this notice in the Federal Register prior to cancelling affected uses. B. Request for Voluntary Cancellation of Manufacturing Use, and Liquid Formulation Products Under section 6( f)( 1)( A) of FIFRA, registrants may request, at any time, that their pesticide registrations be canceled or amended to terminate one or more pesticide uses. Section 6( f)( 1)( B) of FIFRA requires that before acting on a request for voluntary cancellation, EPA must provide a 30­ day public comment period on the request for voluntary cancellation. In addition, section 6( f)( 1)( C) of FIFRA requires that EPA provide a 180­ day comment period on a request for voluntary termination of any minor agricultural use before granting the request, unless: ( 1) The registrants request a waiver of the comment period, or ( 2) the Administrator determines that continued use of the pesticide would pose an unreasonable adverse effect on the environment. EPA anticipates granting the cancellation request shortly after considering the comments received during the 30­ day comment period for this notice. Pursuant to section 6( f)( 1)( A) of FIFRA, the following companies have submitted a request to cancel three pesticide products uses registered under section 3 or 24( c) of FIFRA containing chlorpyrifos­ methyl. These registrations for which cancellations were requested are in Table 1. Table 1.­­ Registrations with Pending Request for Cancellation ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Intended Effective Date for Registration No. Product Name Cancellation ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 7501­ 41 Gustafson Reldan 4E ( 43.%) Insecticide December 31, 2004 62719­ 42 Reldan F Insecticidal ( 97.%) December 31, 2004 62719­ 43 Reldan 4E ( 43.2%) December 31, 2004 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ III. What is the Agency's Authority for Taking This Action? Section 6( f)( 1) of FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register, make reasonable efforts to inform persons who rely on the pesticide, and provide a 30­ day period in which the public may comment. Thereafter, the Administrator may approve such a request. IV. Procedures for Withdrawal of Request Registrants who choose to withdraw a request for cancellation must submit such withdrawal in writing to the person listed under FOR FURTHER INFORMATION CONTACT, postmarked before May 24, 2002. This written withdrawal of the request for cancellation will apply only to the applicable FIFRA section 6( f)( 1) request listed in this notice. If the product( s) have been subject to a previous cancellation action, the effective date of cancellation and all other provisions of any earlier cancellation action are controlling. The withdrawal request must also include a commitment to pay any reregistration fees due, and to fulfill any applicable unsatisfied data requirements. V. Provisions for Disposition of Existing Stocks The effective date of cancellation will be the date of the cancellation order. The orders effecting these requested cancellations will permit persons other than the registrant to sell, distribute, or use existing stocks for 1 year after December 31, 2003. This policy is in accordance with the Agency's statement of policy as prescribed in the Federal Register of June 26, 1991 ( 56 FR 29362) ( FRL­ 3846­ 4). Exceptions to this general rule will be made if a product poses a risk concern, or is in noncompliance with reregistration requirements, or is subject to a Data Call­ In. In all cases, product­ specific disposition dates will be given in the cancellation orders. Existing stocks are those stocks of registered pesticide products which are currently in the United States and which have been packaged, labeled, and released for shipment prior to the effective date of the cancellation action. Registrants would not sell or distribute products bearing old labeling after the stamped approval date of new labels, i. e., labels that conform to the provisions of this document. The following are the existing stocks provisions for the three products being canceled. Liquid Formulations and Manufacturing Use Product ( 7501­ 41, 62719­ 43, and 62719­ 42) Liquid formulation and manufacturing use products bearing the EPA approved amended labels shall not be sold or distributed by registrants after December 31, 2003. Persons other than registrants may not sell, distribute, or use existing stocks after December 31, 2004. In lieu of putting end use dates on the label, registrants have agreed to [[ Page 20121]] notify their distributors of the last use date and the rationale for it. Exception to these general rules will be made in specific cases when more stringent restrictions on sale, distribution, or use of the products or their ingredients have already been imposed, as in a Special Review action, or where the Agency has identified significant potential risk concerns associated with a particular chemical. List of Subjects Environmental protection, Chlorpyrifos­ methyl, Pesticides and pests, Stored grain. Dated: April 2, 2002. Lois A. Rossi, Director, Information Resources Services Division, Office of Pesticide Programs. [ FR Doc. 02­ 9654 Filed 4­ 23­ 02; 8: 45 am] BILLING CODE 6560­ 50­ S

epa

2024-06-07T20:31:41.490343

regulations

EPA-HQ-OPP-2002-0027-0001

Notice

ABT Associates, Inc. and Syracuse Research Corp. (SRC); Transfer of Data

ABT Associates, Inc. and Syracuse Research Corp. ( SRC); Transfer of Data [ Federal Register: April 24, 2002 ( Volume 67, Number 79)] [ Notices] [ Page 20114­ 20115] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr24ap02­ 91] ===================================================================== == ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ENVIRONMENTAL PROTECTION AGENCY [ OPP­ 2002­ 0027; FRL­ 6834­ 6] ABT Associates, Inc. and Syracuse Research Corp. ( SRC); Transfer of Data AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ SUMMARY: This notice announces that pesticide­ related information submitted to EPA's Office of Pesticide Programs ( OPP) pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) and the Federal Food, Drug, and Cosmetic Act ( FFDCA), including information that may have been claimed as Confidential Business Information ( CBI) by the submitter, will be transferred to ABT Associates, Inc. and its subcontractor, Syracuse Research Corp., in accordance with 40 CFR 2.307( h)( 3) and 2.308( i)( 2). ABT Associates, Inc. and its subcontractor, Syracuse Research Corp., have been awarded a contract to perform work for OPP, and access to this information will enable ABT Associates, Inc. and its subcontractor, Syracuse Research Corp., to fulfill the obligations of the contract. DATES: ABT Associates, Inc. and its subcontractor, Syracuse Research Corp., will be given access to this information on or before April 29, 2002. FOR FURTHER INFORMATION CONTACT: By mail: Erik Johnson, FIFRA Security Officer, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 305­ 7248; e­ mail address: johnson. erik@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action applies to the public in general. As such, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov. To access this document, on the home page select Laws and Regulations,'' Regulations and Proposed Rules,'' and then look up the entry for this document under the Federal Register­­ Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. II. Contractor Requirements Under Contract No. 68­ W0­ 1039, ABT Associates, Inc. and its subcontractor, Syracuse Research Corp., will perform the following: In response to the Food Quality Protection Act ( FQPA), the Office of Science Coordination and Policy ( OSCP) and the Office of Pesticide Programs ( OPP) are conducting a pilot project to evaluate existing toxicity data and data bases in the Agency and the scientific literature for a sample group of approximately 30 pesticide active ingredients. Toxicity and endocrine­ related mechanistic data shall be examined in detail to determine their adequacy to assess each chemical's potential to affect the endocrine system. For this work assignment, the contractor shall examine Agency toxicity data files, ( primarily located in OPP's Environmental Fate and Effects Division data bases), summary documents, electronic files, and the scientific literature for indications of endocrine system interaction, perturbation, or modulation in wildlife and aquatic organisms for up to 30 pesticide active ingredients. OPP has determined that access by ABT Associates, Inc. and its subcontractor, Syracuse Research Corp., to information on all pesticide chemicals is necessary, for the performance of this contract. Some of this information may be entitled to confidential treatment. The information has been submitted to EPA under sections 3, 4, 6, and 7 of FIFRA and under sections 408 and 409 of FFDCA. In accordance with the requirements of 40 CFR 2.307( h)( 2), the contract with ABT Associates, Inc. and its subcontractor, Syracuse Research Corp., prohibits the use of information for any purpose not specified in the contract; prohibits disclosure of the information to a third party without prior written approval from the agency; and requires that each official and employee of the contractor sign an agreement to protect the information from unauthorized release and to handle it in accordance with the FIFRA Information Security Manual. In addition, ABT Associates, Inc. and its subcontractor, Syracuse Research Corp., are required to submit for EPA approval a security plan under which any CBI will be secured and protected against unauthorized release or compromise. No information will be provided to ABT Associates, Inc. and its subcontractor, Syracuse Research Corp., until the requirements in this document have been fully satisfied. Records of information provided to ABT Associates, Inc. and its subcontractor, Syracuse Research Corp., will be maintained by EPA Project Officers for this contract. All information supplied to ABT Associates, Inc. and its subcontractor, Syracuse Research Corp., by EPA for use in connection with this contract will be returned to EPA when ABT Associates, Inc. and its [[ Page 20115]] subcontractor, Syracuse Research Corp., have completed their work. List of Subjects Environmental protection, Business and industry, Government contracts, Government property, Security measures. Dated: April 10, 2002. Linda Vlier Moos, Acting Director, Information Resources and Services Division, Office of Pesticide Programs. [ FR Doc. 02­ 9792 Filed 4­ 23­ 02; 8: 45 am] BILLING CODE 6560­ 50­ S

epa

2024-06-07T20:31:41.493593

regulations

EPA-HQ-OPP-2002-0033-0001

Notice

Propanil; Notice of Pesticide Tolerance Reassessment Decision and Availability of Risk Assessment

38653 Federal Register / Vol. 67, No. 108 / Wednesday, June 5, 2002 / Notices requirements. As noted above, CARB has submitted a letter to EPA on May 21, 2002 which requests that EPA confirm that its 2001 ZEV amendments are within the scope of waivers previously granted by EPA. ( B) Background and Discussion Section 209( a) of the Clean Air Act, as amended (`` Act''), 42 U. S. C. 7543( a), provides: No State or any political subdivision thereof shall adopt or attempt to enforce any standard relating to the control of emissions from new motor vehicles or new motor vehicle engines subject to this part. No state shall require certification, inspection or any other approval relating to the control of emission from any new motor vehicle or new motor vehicle engine as condition precedent to the initial retail sale, titling ( if any), or registration of such motor vehicle, motor vehicle engine, or equipment. Section 209( b)( 1) of the Act requires the Administrator, after notice and opportunity for public hearing, to waive application of the prohibitions of section 209( a) for any state that has adopted standards ( other than crankcase emission standards) for the control of emissions from new motor vehicles or new motor vehicle engines prior to March 30, 1966, if the state determines that the state standards will be, in the aggregate, at least as protective of public health and welfare as applicable federal standards. California is the only state that is qualified to seek and receive a waiver under section 209( b). The Administrator must grant a waiver unless she finds that ( A) the determination of the state is arbitrary and capricious, ( B) the state does not need the state standards to meet compelling and extraordinary conditions, or ( C) the state standards and accompanying enforcement procedures are not consistent with section 202( a) of the Act. CARB's May 21, 2002 letter to the Administrator notified EPA that it had adopted amendments to its ZEV program. The regulatory amendments covered by CARB's request are amendments to title 13, California Code of Regulations ( CCR), section 1962 and the incorporated `` California Exhaust Emission Standards and Test Procedures for 2003 and Subsequent Model Zero­ Emission Vehicles, and 2001 and Subsequent Model Hybrid­ Electric vehicles, in the Passenger Car, Light­ Duty Truck, and Medium­ Duty Vehicle Classes,'' and amendments to section 1900( b)( 19)­( 21), section 1960.1( k) and section 1961( a)( 8)( A) and ( d), title 13 CCR. When EPA receives new waiver requests from CARB, EPA traditionally publishes a notice of opportunity for public hearing and comment and then publishes a decision in the Federal Register following the public comment period. In contrast, when EPA receives within the scope waiver requests from CARB, EPA traditionally publishes a decision in the Federal Register and concurrently invites public comment if an interested part is opposed to EPA's decision. Because EPA has already received written comment on CARB's within the scope request for its 1999 ZEV amendments and because EPA anticipates a similar level of interest in CARB's 2001 ZEV amendments, EPA invites comment on the following issues: ( 1) Whether California's 1999 and 2001 ZEV amendments should be considered together or separately; ( 2) whether California's 2001 ZEV amendments ( a) undermine California's previous determination that its standards, in the aggregate, are at least as protective of public health and welfare as comparable Federal standards, ( b) affect the consistency of California's requirements with section 202( a) of the Act, and ( c) raise new issues affecting EPA's previous waiver determinations; and ( 3) whether ( a) California's determination that its 2001 ZEV amendments, to the extent they are not within the scope of previous waivers, are at least as protective of public health and welfare as applicable federal standards is arbitrary and capricious, ( b) California needs separate standards to meet compelling and extraordinary conditions, and ( c) California's standards and accompanying enforcement procedures are consistent with section 202( a) of the Act? Procedures for Public Participation In recognition that public hearings are designed to give interested parties an opportunity to participate in this proceeding, there are no adverse parties as such. Statements by participants will not be subject to cross­ examination by other participants without special approval by the presiding officer. The presiding officer is authorized to strike from the record statements that he or she deems irrelevant or repetitious and to impose reasonable time limits on the duration of the statement of any participant. If hearing( s) are held, the Agency will make a verbatim record of the proceedings. Interested parties may arrange with the reporter at the hearing( s) to obtain a copy of the transcript at their own expense. Regardless of whether public hearing( s) are held, EPA will keep the record open until July 22, 2002. Upon expiration of the comment period, the Administrator will render a decision on CARB's request based on the record of the public hearing( s), if any, relevant written submissions, and other information that she deems pertinent. All information will be available for inspection at EPA Air Docket. ( Docket No. A 2002 11). EPA requests that parties wishing to submit comments specify which issue, noted above, they are addressing. Commenters may submit one document which addresses several issues but they should separate, to the extent possible, those comments that relate to the 1999 ZEV amendments, those that relate to the 2001 ZEV amendments, and those that relate to the LEVII amendments. Persons with comments containing proprietary information must distinguish such information from other comments to the greatest possible extent and label it as `` Confidential Business Information'' ( CBI). If a person making comments wants EPA to base its decision in part on a submission labeled CBI, then a nonconfidential version of the document that summarizes the key data or information should be submitted for the public docket. To ensure that proprietary information is not inadvertently placed in the docket, submissions containing such information should be sent directly to the contact person listed above and not to the public docket. Information covered by a claim of confidentiality will be disclosed by EPA only to the extent allowed and by the procedures set forth in 40 CFR part 2. If no claim of confidentiality accompanies the submission when EPA receives it, EPA will make it available to the public without further notice to the person making comments. Dated: May 30, 2002. Jeffrey R. Holmstead, Assistant Administrator for Air and Radiation. [ FR Doc. 02 14041 Filed 6 4 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0033; FRL 7179 4] Propanil; Notice of Pesticide Tolerance Reassessment Decision and Availability of Risk Assessments AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice represents the Agency's tolerance reassessment VerDate May< 23> 2002 20: 45 Jun 04, 2002 Jkt 197001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 05JNN1. SGM pfrm12 PsN: 05JNN1 38654 Federal Register / Vol. 67, No. 108 / Wednesday, June 5, 2002 / Notices decision for propanil. It announces the Agency's tolerance reassessment decision and releases the human health and ecological effects risk assessments and related documents supporting this decision to the public. The Agency's reassessment of dietary risk, including public exposure through food and drinking water as required by the Federal Food, Drug and Cosmetic Act ( FFDCA) indicates that propanil poses no risk concerns; therefore, no risk mitigation is needed and no further actions related to dietary risk are warranted at this time. The Agency will complete a Reregistration Eligibility Decision ( RED) document for propanil later in 2002, which will address any possible risk to workers and the environment and any confirmatory data needs. DATES: Public comments on the tolerance reassessment decision for propanil are requested on or before July 5, 2002. In the absence of substantive comments, the tolerance reassessment decision will be considered final. Comments on the human health and ecological effects risk assessments must be submitted on or before August 5, 2002. ADDRESSES: Comments, may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP 2002 0033 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: Carmen Rodia, Chemical Review Manager, Special Review and Reregistration Division ( 7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: ( 703) 306 0327; email address: rodia. carmen@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general, nevertheless, a wide range of stakeholders will be interested in obtaining information on propanil, including environmental, human health and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the use of pesticides on food. Since other entities also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. On the Home Page select `` Laws and Regulations,'' `` Regulations and Proposed Rules'' and then look up the entry for this document under the `` Federal Register Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. To access the OPPTS Harmonized Guideline referenced in this document, go directly to the guidelines at http:// www. epa. gov/ opptsfrs/ home/ guidelin. htm. In addition, copies of the documents related to the propanil risk assessments and tolerance reassessment decision released to the public may be accessed at http:// www. epa. gov/ pesticides/ reregistration/ status. htm. 2. In person. The Agency has established an official record for this action under docket ID number OPP 2002 0033. The official record consists of the documents specifically referenced in this action and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Room 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805. C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP 2002 0033 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805. 3. Electronically. You may submit your comments electronically by e­ mail to: opp­ docket@ epa. gov, or you can submit a computer disk as described in this unit. Do not submit any information electronically that you consider to be CBI. Electronic comments must be submitted as an ASCII file avoiding use of special characters and any form of encryption. Comments and data will also be accepted on standard disks in WordPerfect 6.1/ 8.0 or ASCII file format. All comments in electronic form must be identified by docket ID number OPP 2002 0033. Electronic comments may also be filed online at many Federal Depository Libraries. D. How Should I Handle CBI that I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. VerDate May< 23> 2002 20: 45 Jun 04, 2002 Jkt 197001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 05JNN1. SGM pfrm12 PsN: 05JNN1 38655 Federal Register / Vol. 67, No. 108 / Wednesday, June 5, 2002 / Notices E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the notice or collection activity. 7. Make sure to submit your comments by the deadline in this document. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. Tolerance Reassessment and Risk Management Decision The Agency has completed its assessment of the dietary risk of propanil ( 3', 4'­ dichloropropionanilide) and its principle metabolic degradate 3,4­ dichloroaniline ( 3,4­ DCA), and has determined that the level of dietary risk from exposure as a result of currently registered uses of propanil is not of concern to the Agency. Therefore, no mitigation measures are needed and no further actions are warranted at this time. Tolerances for the registered uses of propanil are reassessed. The Agency is still reviewing any possible risk to workers and the environment and, if risk mitigation is necessary, the Agency will provide its risk management decision, as well as any confirmatory data requirements, in the RED scheduled for later in 2002. The Agency may determine that further action is necessary, once it is determined whether the anilides, such as propanil, share a common mechanism of toxicity as a group or with other neuroendocrine­ disrupting chemicals. Such an incremental approach to the tolerance reassessment process is consistent with the Agency's goal of improving transparency in implementing FFDCA. For propanil, the established tolerances remain in effect until such time as a full reassessment of the cumulative risk from all anilide pesticides, such as propanil, may be needed and is completed. III. Background This notice announces the tolerance reassessment decision for propanil. This decision has been developed as part of the public participation process that EPA and the United States Department of Agriculture ( USDA) are using to involve the public in the reassessment of pesticide tolerances under FFDCA. EPA must review tolerances and tolerance exemptions that were in effect when the Food Quality Protection Act ( FQPA) was enacted in August of 1996 to ensure that these existing pesticide residue limits for food and feed commodities meet the safety standard of the new law. Propanil was first registered in 1973 and is therefore subject to both reregistration and tolerance assessment under the FQPA amendments to FFDCA. The FQPA amendments to FFDCA requires EPA to review all the tolerances for registered chemicals in effect on or before the date of the enactment. In reviewing these tolerances, the Agency must consider, among other things, aggregate risks from nonoccupational sources of pesticide exposure, whether there is increased susceptibility to infants and children and the cumulative effects of pesticides with a common mechanism of toxicity. The tolerances are considered reassessed once the safety finding has been made or a revocation occurs. FFDCA requires that the Agency, when considering whether to establish, modify, or revoke a tolerance, consider `` available information'' concerning the cumulative effects of a particular pesticide's residues and `` other substances that have a common mechanism of toxicity.'' The Agency does not have sufficient information at this time to determine whether the anilide pesticides, such as propanil, share a common mechanism of toxicity. The Agency's human health findings for the pesticide propanil, discussed in Unit IV., are presented fully in the document: `` Propanil­ HED Revised Human Health Risk Assessment, February 28, 2002.'' The risk assessments and other documents pertaining to the propanil tolerance reassessment decision are available for viewing in the public docket ( see Unit I. B. 2.) or on the Agency's website at http:// www. epa. gov/ pesticides/ reregistration/ status. htm. IV. Use Summary Propanil is a selective post­ emergent herbicide registered on rice, barley, oats, and spring wheat to control broadleaf and grass weeds in commercial settings. Propanil is also registered ( but not currently marketed) for turf use at commercial sod farms. There are no existing or proposed residential uses of propanil products. Propanil is formulated as an emulsifiable concentrate liquid ( 16.6% 58% active ingredient), a water dispersable granule ( or dry flowable) ( 59.6% 81% active ingredient), a soluble concentrate liquid ( 41.2% 80.2% active ingredient), and a flowable concentrate ( 41.2% active ingredient). Propanil is typically applied as a broadcast treatment by groundboom sprayers and aerial equipment. The estimate for total domestic use ( annual average) is approximately 7 million pounds of active ingredient on a total of approximately 2 million acres treated. The crop with the highest use is rice, which accounts for approximately 99% of the annual average. Fifty to seventy percent of the U. S. rice crop is treated with propanil. Small grains comprise the remaining 1% of the annual average. V. Dietary Food Risks EPA has not assessed acute dietary risk for propanil since no appropriate endpoint attributable to a single exposure ( dose) could be identified. An acute dietary reference dose was not established. Chronic dietary risk is calculated by using the average consumption value for food and average residue values on those foods. A risk estimate that is less than 100% of the chronic population adjusted dose ( cPAD), the dose at which an individual could be exposed over the course of a lifetime and no adverse health effects would be expected, does not exceed the Agency's level of concern. The cPAD is the chronic dietary reference dose ( RfD) adjusted for the FQPA safety factor. Chronic risk estimates from exposures to propanil in food do not exceed the Agency's level of concern ( i. e., they are less than 100% of the cPAD). The chronic dietary ( food only) risk estimate is 13% of the cPAD, for the most highly exposed population subgroup, all infants (< 1 year). The toxicity endpoint for the chronic dietary assessment is decreased hemoglobin, red blood cell count and/ or packed cell volumes and is calculated using the lowest observed adverse effect level ( LOAEL) ( 9 milligrams/ kilogram/ day ( mg/ kg/ day)) from the chronic/ carcinogenicity study in the rat ( no observed adverse effect level ( NOAEL)) was identified). The FQPA safety factor of 10x was retained for chronic exposures based on increased susceptibility following prenatal and postnatal exposure, the VerDate May< 23> 2002 20: 45 Jun 04, 2002 Jkt 197001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 05JNN1. SGM pfrm12 PsN: 05JNN1 38656 Federal Register / Vol. 67, No. 108 / Wednesday, June 5, 2002 / Notices lack of a developmental neurotoxicity study; and neuroendocrine disruption in the rat. The uncertainty factor ( UF) used in the RfD derivation is 300x. The UF is 100x ( 10x for interspecies extrapolation and 10x for intraspecies variability). An additional UF of 3x is applied for the use of a LOAEL instead of a NOAEL for an overall UF of 3,000x. Thus, the chronic RfD is 0.03 mg/ kg/ day and the cPAD is 0.003 mg/ kg/ day. The propanil chronic dietary exposure assessment was conducted using the Dietary Exposure Evaluation Model ( DEEMTM) Software Version 7.73. The DEEMTM analysis evaluated the individual food consumption as reported by respondents in the USDA's Continuing Surveys of Food Intake by Individuals ( CSFII), 1989 1992, and accumulated exposure to the chemical for each commodity. To calculate chronic dietary risk from propanil use on food, EPA used the DEEMTM, along with average residue estimated from field trial data, and assumed 70% of the rice crop was treated with propanil. Field trial data are generally considered to be an upper­ bound estimate of actual residues, and 70% is also a high­ end estimate of the percent of the present rice crop treated. Thus, actual dietary risk is likely to be less than indicated by EPA's assessment. Food and Drug Administration ( FDA) monitoring data were available, but not sufficient, due to lack of analysis for 3,4­ DCA. VI. Dietary Drinking Water Risks Drinking water exposure to pesticides can occur through ground water and surface water contamination. EPA considers both acute ( 1 day) and chronic ( lifetime) drinking water risks and uses either modeling or actual monitoring data, if available, to estimate those risks. To determine the maximum allowable contribution of water allowed in the diet, EPA first looks at how much of the overall allowable risk is contributed by food, then calculates a `` drinking water level of comparison'' ( DWLOC) to determine whether modeled or monitoring estimates exceed this level. In the case of propanil, no acute drinking water assessment has been conducted, because no acute endpoint was identified. The calculated chronic DWLOCs for propanil are 26 parts per billion ( ppb) for children, 86 ppb for adult females, and 100 ppb for adult males. Available data indicate that propanil will not persist in the environment and is in the medium mobility class for sand, sandy loam and clay loam soils, based on available mobility studies. Due to its mobility, propanil could possibly reach ground water but due to its rapid metabolism in a water/ soil matrix, it is unlikely to persist for a sufficient amount of time to leach in significant quantities. ( The possible exception are sites of extreme vulnerability and low metabolic capacity which would most likely occur only for terrestrial uses. However, if propanil does reach ground water in these vulnerable areas, it is expected to be stable). Propanil and its principle metabolic degradate, 3,4­ DCA, and residues convertible to 3,4­ DCA are the residues of concern for the drinking water risk assessment. Monitoring data for propanil residues in ground water and surface water are available but not adequate to develop estimated environmental concentrations ( EECs) for the aggregate dietary ( food and water) risk assessment. Although not targeted to specific propanil use areas, United States Geological Survey ( USGS) monitoring data do provide some information on the magnitude and frequency of propanil and 3,4­ DCA detections. Propanil was found in about 3% of the 1,560 surface water samples analyzed with a maximum concentration of 2 parts per billion ( ppb). 3,4­ DCA was found in about 50% of the 68 samples with a maximum concentration of 8.9 ppb. All detects are well below the DWLOCs. Models have been used to estimate ground water and surface water concentrations expected from normal agricultural use. Estimated surface water EECs, a range of 6 72 ppb, are below the DWLOC for all population subgroups except for children at the upper­ bound EEC of 72 ppb. This subpopulation of children could be an area of concern because exposure estimates for this group exceed the DWLOC; however, the Agency believes that the concerns have been addressed by the conservative assumptions ( field trial residue levels and 70% crop treated) used in the chronic dietary calculation. In this case, the Agency concludes that actual residues of propanil per se and 3,4­ dichloroaniline ( 3,4­ DCA combined) are likely to be less than the estimated DWLOC; and a conclusion can be drawn that no adverse toxicological effect will occur due to aggregate chronic exposure. Estimated drinking water concentrations are based on EPA's Pesticide Root Zone Model/ Exposure Analysis Modeling System ( PRZM/ EXAMS) screening model, which is a Tier II assessment that provides more refined, less upper­ bound assumptions. The range of EECs represents different rice growing areas and normal versus overflow release. Estimated ground water concentrations are based on the Screening Concentration in Ground Water ( SCI­ GROW) model, which is a Tier I assessment that provides a highend estimate. The drinking water EEC for ground water ( 0.35 ppb) is below the DWLOC for all population subgroups. VII. Aggregate Risks The aggregate risk assessment for propanil examines the combined risk from exposure through food and drinking water only. Chronic residential exposures are not expected because there are no residential uses for propanil and, thus, are not included in the aggregate risk assessment. As detailed above, for propanil the only interval of exposure to be assessed is chronic ( 1 year or more), and the only route of exposure to be assessed is oral ( food and water). Generally, combined risks from these exposures that are less than 100% of the cPAD, are not considered to be a risk concern. EPA has also evaluated the potential aggregate exposure to 3,4­ DCA. Available data indicates that 3,4­ DCA is a major metabolic degradate of propanil. 3,4­ DCA is also a metabolite of linuron and diuron, but to a lesser extent. The Agency's Metabolism Assessment Review Committee does not recommend aggregating residues of 3,4­ DCA for the propanil, linuron, and diuron risk assessments. 3,4­ DCA is a significant residue of concern for propanil, but is not a residue of concern per se for linuron or diuron. Submitted data indicate that the maximum amount of 3,4­ DCA formed from propanil is approximately 50% of propanil initially applied, based on results from the aerobic soil metabolism study. Neither diuron nor linuron metabolize to 3,4­ DCA in appreciable amounts ( less than 1% detection rate) of the parent compound in animal, plant, or water metabolism studies. The registered uses for propanil, linuron, and diuron result in minimal co­ occurrence of use. That is, there is very little overlap of use patterns and the use patterns are geographically limited for each chemical. Therefore, the risk assessments for each individual chemical fully assess the risks posed by the parent chemical and the metabolite, 3,4­ DCA, individually. VIII. Residential Risk Propanil is not registered for residential ( home) use, nor is it used in or around public buildings, schools, or recreational areas where children might be exposed. Thus, there is no residential exposure to aggregate with the dietary exposure. The use of propanil on turf is restricted to commercial sod farms only. Although propanil­ treated sod may VerDate May< 23> 2002 20: 45 Jun 04, 2002 Jkt 197001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 05JNN1. SGM pfrm12 PsN: 05JNN1 38657 Federal Register / Vol. 67, No. 108 / Wednesday, June 5, 2002 / Notices eventually be used in residential settings ( i. e., residential lawns), propanil residues are not expected to exceed levels of concern for residential post­ application risk. Since the proposed use of propanil on turf is postemergent applied at sod farms early in the turf growing season ( well before harvest), the Agency concludes that the amount of time is adequate to allow residue dissipation to a level that would not pose any significant exposure to residents. IX. Occupational Risk and Ecological Risk The Agency will assess occupational and ecological risks, any necessary mitigation as well as the need for confirmatory data in the forthcoming RED. X. Tolerance Reassessment Summary The existing tolerances for residues of propanil in/ on plant, animal and processed commodities are established under 40 CFR 180.274( a)( 1) and ( a)( 2). These tolerances are currently expressed as the combined residues of propanil ( 3', 4'­ dichloropropionanilide) and its metabolites ( calculated as propanil). The Agency is now recommending that the propanil tolerance expression for plant and animal commodities be revised to specify that the residues of concern are propanil and its related compounds convertible to 3,4­ DCA. To eliminate redundancy, the propanil tolerances separately listed under 40 CFR 180.274( a)( 2) should be removed and 40 CFR 180.274( a)( 1) should be redesignated as 40 CFR 180.274( a). The Agency has updated the list of raw agricultural and processed commodities and feedstuffs derived from crops ( Table 1, OPPTS GLN 860.1000). As a result of these changes, propanil tolerances for certain raw agricultural commodities that have been removed from the livestock feed table need to be revoked. A number of tolerances are being revised ( increased or decreased) to reflect updates to the propanil data base based on the submission of new livestock feeding studies, analytical methods, processing data, recovery methods, and/ or field trial residue data. Additionally, some commodity definitions must be updated and/ or corrected. A summary of propanil tolerance reassessments is presented below in Table 1. Adequate residue data have been submitted to support the established tolerances for barley, grain; cattle, fat; goat, fat; hog, fat; horse, fat; milk; oat, grain; poultry, meat; rice, straw; sheep, fat; and wheat, straw. For these commodities, the established tolerances were found to be appropriate and will not change as part of this tolerance reassessment. The established tolerance levels for barley, straw; oat, straw, and wheat, straw must be increased to reflect new recovery procedures. The established tolerance levels for cattle, meat byproducts; egg; goat, meat byproducts; hog, meat byproducts; horse, meat byproducts; poultry, meat byproducts, and sheep, meat byproducts have been increased based on the results of livestock feeding studies and revised dietary burden ( exposure) to propanil. For rice, grain; rice, bran, and rice, hull, the existing tolerance levels were increased since data demonstrate that residues concentrate in bran and hulls when rice is processed, based on a reevaluation of crop field trial data. The available data indicate that the tolerance levels can be decreased for cattle, meat; goat, meat; hog, meat; horse, meat; poultry, fat; and sheep, meat based on the results of a ruminant feeding study and a revised dietary burden. Group commodity definitions will be revised as noted in Table 1. The established tolerances for rice mill fractions and rice polishings should be revoked according to Table 1 of OPPTS GLN 860.1000, since these commodities are no longer considered to be significant livestock feed items. As a result, the tolerances are no longer needed. Tolerances To Be Proposed Under 40 CFR 180.274( a) Adequate residue data have been submitted for the establishment of propanil tolerances for crayfish; oat, forage, and wheat, forage based on the crayfish metabolism study and wheat forage data. Inadequate residue data are available for the establishment of propanil tolerances for barley, hay; oat, hay, and wheat, hay. The requested data for wheat, hay will be translated to barley, hay, and oat, hay. Tolerances Currently Listed Under 40 CFR 180.274( a)( 2) The tolerances currently listed in 40 CFR 180.274( a)( 2) are inadvertent duplicates of the tolerances established for the same commodities listed in 40 CFR 180.274( a)( 1). The tolerances listed in 40 CFR 180.274( a)( 2) should be removed because the duplicate tolerances found there are not needed. TABLE 1. TOLERANCE REASSESSMENT SUMMARY FOR PROPANILTOLERANCES CURRENTLY LISTED UNDER 40 CFR 180.247( A)( 1) Commodity Current Tolerance ( ppm) Reassessed Tolerance ( ppm) Comment ( Corrected Commodity Definition) Barley, grain .2 0.20 Barley, straw .75 1.5 Increased residues reflect new recovery procedures. Cattle, fat 0.1( N) 1 0.10 Cattle, mbyp 0.1( N) 1.0 ( Cattle, meat byproducts) Increased residues based on ruminant feeding studies and a revised dietary burden from residues in rice. Cattle, meat 0.1( N) 0.05 Decreased residues based on ruminant feeding studies and a revised dietary burden from residues in rice. VerDate May< 23> 2002 20: 45 Jun 04, 2002 Jkt 197001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 05JNN1. SGM pfrm12 PsN: 05JNN1 38658 Federal Register / Vol. 67, No. 108 / Wednesday, June 5, 2002 / Notices TABLE 1. TOLERANCE REASSESSMENT SUMMARY FOR PROPANILTOLERANCES CURRENTLY LISTED UNDER 40 CFR 180.247( A)( 1) Continued Commodity Current Tolerance ( ppm) Reassessed Tolerance ( ppm) Comment ( Corrected Commodity Definition) Eggs 0.05( N) 0.30 ( Egg) Increased residues based on ruminant feeding studies and a revised dietary burden from residues in rice. Goats, fat 0.1( N) 0.10 ( Goat, fat) Goats, mbyp 0.1( N) 0.80 ( Goat, meat byproducts) Increased residues based on ruminant feeding studies and a revised dietary burden from residues in rice. Goats, meat 0.1( N) 0.05 ( Goat, meat) Decreased residues based on ruminant feeding studies and a revised dietary burden from residues in rice. Hogs, fat 0.1( N) 0.10 ( Hog, fat) Hogs, mbyp 0.1( N) 0.80 ( Hog, meat byproducts) Increased residues based on ruminant feeding studies and a revised dietary burden from residues in rice. Hogs, meat 0.1( N) 0.05 ( Hog, meat) Decreased residues based on ruminant feeding studies and a revised dietary burden from residues in rice. Horses, fat 0.1( N) 0.10 ( Horse, fat) Horses, mbyp 0.1( N) 0.80 ( Horse, meat byproducts) Increased residues based on ruminant feeding studies and a revised dietary burden from residues in rice. Horses, meat 0.1( N) 0.05 ( Horse, meat) Decreased residues based on ruminant feeding studies and a revised dietary burden from residues in rice. Milk 0.05( N) 0.05 Oat, grain .2 0.20 Oat, straw .75 1.5 Increased residues reflect new recovery procedures. Poultry, fat 0.1( N) 0.05 Decreased residues based on ruminant feeding studies and a revised dietary burden from residues in rice. Poultry, mbyp 0.1( N) 0.50 ( Poultry, meat byproducts) Increased residues based on ruminant feeding studies and a revised dietary burden from residues in rice. Poultry, meat 0.1( N) 0.10 Rice 2 10 ( Rice, grain) Tolerances were increased since residues were found to concentrate when rice is processed. Rice bran 10 40 ( Rice, bran) Tolerances were increased since residues were found to concentrate when rice is processed. Rice hulls 10 30 ( Rice, hull) Tolerances were increased since residues were found to concentrate when rice is processed. VerDate May< 23> 2002 20: 45 Jun 04, 2002 Jkt 197001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 05JNN1. SGM pfrm12 PsN: 05JNN1 38659 Federal Register / Vol. 67, No. 108 / Wednesday, June 5, 2002 / Notices TABLE 1. TOLERANCE REASSESSMENT SUMMARY FOR PROPANILTOLERANCES CURRENTLY LISTED UNDER 40 CFR 180.247( A)( 1) Continued Commodity Current Tolerance ( ppm) Reassessed Tolerance ( ppm) Comment ( Corrected Commodity Definition) Rice mill fractions 10 Revoke These items have been deleted from Table 1 of OPPTS GLN 860.1000. Rice polishings 10 Revoke Rice, straw 75( N) 75 Sheep, fat 0.1( N) 0.10 Sheep, mbyp 0.1( N) 0.80 ( Sheep, meat byproducts) Increased residues based on ruminant feeding studies and a revised dietary burden from residues in rice. Sheep, meat 0.1( N) 0.05 Decreased residues based on ruminant feeding studies and a revised dietary burden from residues in rice. Wheat, grain 0.2 0.20 Wheat, straw 0.75 1.5 Increased residues reflect new recovery procedures. 1( N) = negligible residues; however, the Agency is removing the ``( N)'' designation from all entries to conform to current Agency administrative practice. TABLE 2. TOLERANCE REASSESSMENT SUMMARY FOR PROPANILTOLERANCES TO BE PROPOSED UNDER 40 CFR 180.274( A) Commodity Current Tolerance ( ppm) Reassessed Tolerance ( ppm) Comment ( Corrected Commodity Definition) Barley, hay None To be determined1 The requested data for wheat, hay will be translated to barley, hay. Crayfish None 0.05 Oat, forage None 0.20 The available data for wheat, forage will be translated to oat, forage. Oat, hay None To be determined1 The requested data for wheat, hay will be translated to oat, hay. Wheat, forage None 0.20 Wheat, hay None To be determined1 Additional data are required. 1The establishment of these tolerance( s) cannot be made at this time because additional data are required. TABLE 3. TOLERANCE REASSESSMENT SUMMARY FOR PROPANIL TOLERANCES CURRENTLY LISTED UNDER 40 CFR 180.274( A)( 2) Commodity Current Tolerance ( ppm) Reassessed Tolerance ( ppm) Comment ( Corrected Commodity Definition) Rice bran 10 Remove These tolerances are not needed because they are inadvertent duplicate tolerances for rice commodities that already exist in 40 CFR 180.274( a)( 1). Rice hulls 10 Remove Rice mill fractions 10 Remove Rice polishings 10 Remove VerDate May< 23> 2002 20: 45 Jun 04, 2002 Jkt 197001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 05JNN1. SGM pfrm12 PsN: 05JNN1 38660 Federal Register / Vol. 67, No. 108 / Wednesday, June 5, 2002 / Notices XI. Codex Harmonization No Codex maximum residue levels ( MRLs) have been established for propanil; therefore, issues of compatibility between Codex MRLs and U. S. tolerances do not exist. List of Subjects Environmental protection, Pesticides and pests, Risk assessment and tolerance reassessment. Dated: May 20, 2002. Lois A. Rossi, Director, Special Review and Reregistration Division, Office of Pesticide Programs. [ FR Doc. 02 13809 Filed 6 4 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0065; FRL 7177 4] Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket control number OPP 2002 0065, must be received on or before July 5, 2002. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. C. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP 2002 0065 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: Sidney Jackson, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 305 7610; e­ mail address: jackson. Sidney@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: Categories NAICS codes Examples of potentially affected entities Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations,'' `` Regulations and Proposed Rules,'' and then look up the entry for this document under the `` Federal Register Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. 2. In person. The Agency has established an official record for this action under docket control number OPP 2002 0065. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Highway, Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805. C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP 2002 0065 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805. 3. Electronically. You may submit your comments electronically by e­ mail to: opp­ docket@ epa. gov, or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in Wordperfect 6.1/ 8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP 2002 0065. Electronic comments may also be filed online at many Federal Depository Libraries. D. How Should I Handle CBI That I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the VerDate May< 23> 2002 20: 45 Jun 04, 2002 Jkt 197001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 05JNN1. SGM pfrm12 PsN: 05JNN1

epa

2024-06-07T20:31:41.496514

regulations

EPA-HQ-OPP-2002-0035-0002

Rule

Nicotine; Tolerance Revocations

Federal Register: May 22, 2002 ( Volume 67, Number 99)] [ Rules and Regulations] [ Page 35912­ 35915] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr22my02­ 7] ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP­ 2002­ 0035; FRL­ 6836­ 7] Nicotine; Tolerance Revocations AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ SUMMARY: This document revokes specific tolerances for residues of nicotine­ containing compounds used as insecticides and for the insecticide nicotine. The regulatory actions in this document are part of the Agency's reregistration program under the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), and the tolerance reassessment requirements of the Federal Food, Drug, and Cosmetic Act ( FFDCA) section 408( q), as amended by the Food Quality Protection Act ( FQPA) of 1996. By law, EPA is required by August 2002 to reassess 66% of the tolerances in existence on August 2, 1996, or about 6,400 tolerances. The regulatory actions in this document pertain to the revocation of 66 tolerances which are counted among tolerance/ exemption reassessments made toward the August, 2002 review deadline. DATES: This regulation is effective August 20, 2002. Objections and requests for hearings, identified by docket control number OPP­ 2002­ 0035, must be received by EPA on or before July 22, 2002. ADDRESSES: Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit IV. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket control number OPP­ 2002­ 0035 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: Joseph Nevola, Special Review and Reregistration Division ( 7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 308­ 8037; e­ mail address: nevola. joseph@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Examples of Categories NAICS Codes Potentially Affected Entities ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select Laws and Regulations,'' Regulations and Proposed Rules,'' and then look up the entry for this document under the Federal Register­­ Environmental Documents.'' You can also go directly to theFederal Register listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. 2. In person. The Agency has established an official record for this action under docket control number OPP­ 2002­ 0035. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305­ 5805. II. Background A. What Action is the Agency Taking? This final rule revokes certain FFDCA tolerances for residues of nicotine­ containing compounds used as insecticides and for the insecticide nicotine in or on specified commodities listed in the regulatory text because nicotine is no longer registered under FIFRA for use on those commodities. The tolerances revoked by this final rule [[ Page 35913]] are no longer necessary to cover residues of nicotine or nicotine­ containing compounds in or on domestically treated commodities or commodities treated outside but imported into the United States. Nicotine or nicotine­ containing compounds are no longer used on those specified commodities within the United States, and no one commented that there was a need for EPA to retain the tolerances to cover nicotine residues in or on imported foods. EPA has historically expressed a concern that retention of tolerances that are not necessary to cover residues in or on legally treated foods has the potential to encourage misuse of pesticides within the United States. Thus, it is EPA's policy to issue a final rule revoking those tolerances for residues of pesticide chemicals for which there are no active registrations under FIFRA, unless any person commenting on the proposal demonstrates a need for the tolerance to cover residues in or on imported commodities or domestic commodities legally treated. In the Federal Register of January 16, 2002 ( 67 FR 2175) ( FRL­ 6810­ 3), EPA issued a proposed rule to revoke the tolerances listed in this final rule. Also, the January 16, 2002 proposal invited public comment for consideration and for support of tolerance retention under FFDCA standards. No comments were received by the Agency. Currently, with the exception of cucumber, lettuce, and tomato, there are no other active food use registrations existing for nicotine­ containing compounds or nicotine. Because no active food use registrations have existed since 1994 and because no comments expressed a need to retain these tolerances for import purposes, EPA is revoking 62 tolerances in 40 CFR 180.167 for residues of nicotine­ containing compounds used as insecticides in or on apples; apricots; artichokes; asparagus; avocados; beans; beets ( with or without tops) or beet greens alone; blackberries; boysenberries; broccoli; brussels sprouts; cabbage; cauliflower; celery; cherries; citrus fruits; collards; corn; cranberries; currants; dewberries; eggplants; gooseberries; grapes; kale; kohlrabi; loganberries; melons; mushrooms; mustard greens; nectarines; okra; onions; parsley; parsnips ( with or without tops) or parsnip greens alone; peaches; pears; peas; peppers; plums ( fresh prunes); pumpkins; quinces; radishes ( with or without tops) or radish tops; raspberries; rutabagas ( with or without tops) or rutabaga tops; spinach; squash; strawberries; summer squash; Swiss chard; turnips ( with or without tops) or turnip greens; and youngberries. Also, EPA is revoking the four tolerances in 40 CFR 180.167a for residues of the insecticide nicotine in eggs; poultry, fat; poultry, meat; and poultry, meat byproducts by removing section 180.167a in its entirety. Because some of the tolerances in 40 CFR 180.167 will not be revoked and will remain in the Code of Federal Regulations, EPA is revising the commodity terminology changes for the remaining tolerances to conform with current Agency administrative practice as follows: cucumbers'' to cucumber'' and tomatoes'' to tomato.'' B. What is the Agency's Authority for Taking this Action? It is EPA's general practice to propose revocation of tolerances for residues of pesticide active ingredients on crop uses for which FIFRA registrations no longer exist. EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States. Nonetheless, EPA will establish and maintain tolerances even when corresponding domestic uses are canceled if the tolerances, which EPA refers to as import tolerances,'' are necessary to allow importation into the United States of food containing such pesticide residues. However, where there are no imported commodities that require these import tolerances, the Agency believes it is appropriate to revoke tolerances for unregistered pesticides in order to prevent potential misuse. C. When Do These Actions Become Effective? These actions become effective 90 days following publication of this final rule in the Federal Register. EPA has delayed the effectiveness of these revocations for 90 days following publication of this final rule to ensure that all affected parties receive notice of EPA's actions. Consequently, the effective date is August 20, 2002. For this final rule, tolerances that were revoked because registered uses did not exist concerned uses which have been canceled for many years. Therefore, commodities containing these pesticide residues should have cleared the channels of trade. Any commodities listed in the regulatory text of this document that are treated with the pesticide subject to this final rule, and that are in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408( 1)( 5), as established by the FQPA. Under this section, any residue of this pesticide in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of FDA that, ( 1) the residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA, and ( 2) the residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from a tolerance. Evidence to show that food was lawfully treated may include records that verify the dates that the pesticide was applied to such food. D. What is the Contribution to Tolerance Reassessment? By law, EPA is required by August 2002 to reassess 66% or about 6,400 of the tolerances in existence on August 2, 1996. EPA is also required to assess the remaining tolerances by August, 2006. As of May 1, 2002, EPA has reassessed over 4,140 tolerances. For counting purposes, the tolerances depicted as with or without tops'' were each counted as two tolerances. In this rule, EPA is revoking 66 tolerances which count as reassessments toward the August, 2002 review deadline of FFDCA section 408( q), as amended by FQPA in 1996. III. Are There Any International Trade Issues Raised by this Final Action? EPA is working to ensure that the U. S. tolerance reassessment program under FQPA does not disrupt international trade. EPA considers Codex Maximum Residue Limits ( MRLs) in setting U. S. tolerances and in reassessing them. MRLs are established by the Codex Committee on Pesticide Residues, a committee within the Codex Alimentarius Commission, an international organization formed to promote the coordination of international food standards. When possible, EPA seeks to harmonize U. S. tolerances with Codex MRLs. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408( b)( 4) requires that EPA explain in a Federal Register document the reasons for departing from the Codex level. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual REDs. EPA has developed guidance concerning submissions for import tolerance support ( 65 FR 35069, June 1, 2000) ( FRL­ 6559­ 3). This guidance will be made available to interested persons. Electronic copies are available on the internet at http:// www. epa. gov/. On the Home Page select Laws and Regulations,'' then select Regulations and Proposed Rules'' and [[ Page 35914]] then look up the entry for this document under Federal Register­­ Environmental Documents.'' You can also go directly to the Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. IV. Objections and Hearing Requests A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP­ 2002­ 0035 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before July 22, 2002. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 202) 260­ 4865. 2. Objection/ hearing fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305­ 5697, by e­ mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit IV. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 2. Mail your copies, identified by docket control number OPP­ 2002­ 0035, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 2. You may also send an electronic copy of your request via e­ mail to: opp­ docket@ epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries. B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested ( 40 CFR 178.32). V. Regulatory Assessment Requirements This final rule will revoke tolerances established under FFDCA section 408. The Office of Management and Budget ( OMB) has exempted this type of action ( i. e., a tolerance revocation for which extraordinary circumstances do not exist) from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866 due to its lack of significance, this final rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104­­ 4). Nor does it require any special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low­ Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any other Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104­ 113, section 12( d) ( 15 U. S. C. 272 note). Pursuant to the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.), the Agency previously assessed whether revocations of tolerances might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. This analysis was published on December 17, 1997 ( 62 FR 66020), and was provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, and available information concerning the pesticide listed in this rule, I certify that this action will not have a significant [[ Page 35915]] economic impact on a substantial number of small entities. Specifically, as per the 1997 notice, EPA has reviewed its available data on imports and foreign pesticide usage and concludes that there is a reasonable international supply of food not treated with nicotine­ containing compounds used as insecticides or the insecticide nicotine. Furthermore, the Agency knows of no extraordinary circumstances that exist as to the present revocations that would change EPA's previous analysis. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' Policies that have federalism implications'' is defined in the Executive Order to include regulations that have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408( n)( 4). For these same reasons, the Agency has determined that this rule does not have any tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' Policies that have tribal implications'' is defined in the Executive Order to include regulations that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VI. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a major rule'' as defined by 5 U. S. C. 804( 2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 2, 2002. Joseph J. Merenda, Acting Director, Office of Pesticide Programs. Therefore, 40 CFR part 180 is amended as follows: PART 180­­[ AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U. S. C. 321( q), 346( a) and 371. 2. Section 180.167 is revised to read as follows: Sec. 180.167 Nicotine­ containing compounds; tolerances for residues. ( a) General. Tolerances are established for residues of nicotine­ containing compounds used as insecticides in or on the following raw agricultural commodities: ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Commodity Parts per million ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Cucumber............................................. 2.0 Lettuce.............................................. 2.0 Tomato............................................... 2.0 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ( b) Section 18 emergency exemptions. [ Reserved] ( c) Tolerances with regional registrations. [ Reserved] ( d) Indirect or inadvertent residues. [ Reserved] Sec. 180.167a [ Removed] 3. Section 180.167a is removed. [ FR Doc. 02­ 12423 Filed 5­ 21­ 02; 8: 45 am] BILLING CODE 6560­ 50­ S

epa

2024-06-07T20:31:41.506836

regulations

EPA-HQ-OPP-2002-0036-0001

Rule

Vinclozolin; Tolerance Revocations; Notice of Channels of Trade Provision

40185 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Rules and Regulations § 80.395 Who is liable for violations under the gasoline sulfur program? ( a) * * * ( 5) GPA use violation. Any refiner, importer, distributor, reseller, carrier, retailer, wholesale purchaser­ consumer, or oxygenate blender who owned, leased, operated, controlled or supervised a facility where a violation of § 80.385( f) occurred, is deemed in violation of § 80.385( f). ( 6) Causing a GPA use violation. Any refiner, importer, distributor, reseller, carrier, retailer, wholesale purchaserconsumer or oxygenate blender who produced, imported, sold, offered for sale, dispensed, supplied, offered for supply, stored, transported, or caused the transportation or storage of gasoline that violates § 80.385( f), is deemed in violation of § 80.385( c). * * * * * ( 12) Joint venture and joint owner liability. Each partner to a joint venture, or each owner of a facility owned by two or more owners, is jointly and severally liable for any violation of this subpart that occurs at the joint venture facility or facility owned by the joint owners, or is committed by the joint venture operation or any of the joint owners of the facility. ( 13) Failure to use credits violation. Any small refiner that has an approved adjustment of its per­ gallon cap under § 80.271 and that does not obtain ( or generate) and use the required number of sulfur credits or allotments under § 80.271( d) by the time it submits its annual report under § 80.370 is deemed in violation of § 80.385( g). * * * * * 18. Section 80.405 is amended by adding a new paragraph ( e) to read as follows: § 80.405 What penalties apply under this subpart? * * * * * ( e) Any person liable under § 80.395( a)( 13) for failing to obtain ( or generate) and use the total required number of sulfur credits or allotments under § 80.271( d) for a calendar year is subject to a separate day of violation for each day until the required number of credits or allotments is used. 19. Section 80.410 is amended by revising paragraph ( h)( 7)( ii) to read as follows: § 80.410 What are the additional requirements for gasoline produced at foreign refineries having an individual small refiner sulfur baseline, foreign refineries granted temporary relief under § 80.270, or baselines for generating credits during 2000 through 2003? * * * * * ( h) * * * ( 7) * * * ( ii) Be licensed as a Certified Public Accountant in the United States and a citizen of the United States, or be approved in advance by EPA based on a demonstration of ability to perform the procedures required in § § 80.125 through 80.130, § 80.415 and this paragraph ( h); and * * * * * 20. Section 80.415 is amended by; a. Adding paragraphs ( a)( 2)( iii), ( a)( 2)( iv), and ( b)( 6); b. Removing paragraphs ( a)( 4) and ( a)( 5); and c. Revising paragraphs ( a)( 3) and ( g)( 4). The additions and revisions read as follows: § 80.415 What are the attest engagement requirements for gasoline sulfur compliance applicable to refiners and importers? * * * * * ( a) * * * ( 2) * * * ( iii) If the annual average sulfur level for any year in which credits were generated for 2000 through 2003 was less than the baseline level under paragraph ( a)( 1) of this section, for small refiners report as a finding the lowest annual sulfur level as the new baseline value for purposes of establishing the small refiner standards under § 80.240, and for GPA gasoline report as a finding the lowest annual sulfur level as the new sulfur level for purposes of credit generation under § 80.310, if lower than 150.00 ppm. ( iv) If the refinery being reviewed is a small refinery and the annual volume under paragraph ( b)( 2) of this section is greater than the baseline volume, calculate the applicable standard in accordance with § 80.240( c). ( 3) Obtain a written representation from the company representative stating the sulfur value that the company used as its baseline and agree that number to paragraphs ( a)( 1) and ( a)( 2) of this section and to the reports to EPA. ( b) * * * ( 6) Agree the information in the refinery's or importer's batch reports filed with EPA under § § 80.75 and 80.105, and any laboratory test results, with the information contained in the annual sulfur report required under § 80.370. * * * * * ( g) * * * ( 4) Obtain the refiner's or importer's representation as to the portion of the deficit under paragraph ( g)( 3) of this section that was resolved with credits, or the portion that was resolved with allotments in 2004 or 2005 only ( compliance deficits for GPA gasoline cannot be carried forward). * * * * * [ FR Doc. 02 13802 Filed 6 11 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP 2002 0036; FRL 6835 6] RIN 2070 AB78 Vinclozolin; Tolerance Revocations and Notice of Channels of Trade Provision Guidance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule. SUMMARY: This final rule revises the tolerances listed in the regulatory text for the fungicide vinclozolin ( 40 CFR 180.380) by revoking the tolerances in or on strawberries, stone fruits, cucumbers, and bell peppers. The Environmental Protection Agency previously published a notice proposing to revoke these four tolerances, subject to public comment, in the Federal Register on July 10, 2001 ( FRL 67797 7). The regulatory actions in this document are part of the Agency's reregistration program under the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), and the tolerance reassessment requirements of the Federal Food, Drug, and Cosmetic Act ( FFDCA). The Food and Drug Administration ( FDA) in a related notice published else where in this issue of the Federal Register is announcing the availability of a guidance document presenting FDA's policy on its planned enforcement approach for foods containing vinclozolin residues. This guidance will assist firms in understanding the types of showing under 408( 1)( 5) of the FFDCA ( hereinafter referred to as the channels of trade provision) that FDA may find satisfactory in accordance with its planned enforcement approach for such section. EPA and FDA are cooperating on this effort. DATES: This final rule is effective June 12, 2002. Objections and requests for hearings, identified by docket ID number OPP 2002 0036, must be received by EPA on or before August 12, 2002. ADDRESSES: Written objections and hearing requests may be submitted by mail, in person, or by courier. Please VerDate May< 23> 2002 00: 52 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 12JNR1. SGM pfrm17 PsN: 12JNR1 40186 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Rules and Regulations follow the detailed instructions for each method as provided in Unit III. To ensure proper receipt by EPA, your objections and hearing requests must identify docket ID number OPP 2002 0036 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: Deanna Scher, Special Review and Reregistration Division ( 7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 308 7043; and e­ mail address: scher. deanna@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: Categories NAICS Examples of Potentially Affected Entities Industry 111 112 311 32532 Crop production Animal production Food manufacturing Pesticide manufacturing This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations,'' `` Regulations and Proposed Rules,'' and then look up the entry for this document under the `` Federal Register Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. 2. In person. The Agency has established an official record for this action under docket ID number OPP 2002 0036. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805. II. Background A. What Action is the Agency Taking? This final rule revokes the FFDCA tolerances for residues of the fungicide vinclozolin in or on strawberries, stone fruits, cucumbers, and bell peppers. In the Federal Register of July 10, 2001 ( 66 FR 35921) ( FRL 6779 7), EPA issued a proposed rule to revoke the tolerances listed in this final rule and invited public comment for consideration and for support of tolerance retention under FFDCA standards. No comments were received by the Agency during the 60 day comment period. The revocation is effective on the date of publication of this final rule. On July 30, 1998, EPA published a notice in the Federal Register ( 63 FR 40710) ( FRL 6020 9) announcing BASF Corporation's request to cancel the FIFRA registered uses for the pesticide vinclozolin on strawberries and stone fruits. These cancellations were precipitated by EPA's determination that aggregate exposure to vinclozolin exceeded the safety standard under FQPA. The notice informed the public of how it could comment on the request for cancellation. One comment was received from the California Strawberry Commission; this comment was fully addressed in a subsequent Federal Register notice ( 63 FR 59557) ( FRL 6041 7) published on November 4, 1998 which announced the approval, with one minor change, of the proposed existing stocks provision for products containing vinclozolin. Under limitations on the use of existing stocks, the application of the pesticide vinclozolin on strawberries and stone fruit became unlawful after January 30, 2000. Therefore, no domestically treated commodities covered by these tolerances are expected to be in the channels of trade. No person has provided comments identifying a need for EPA to retain the tolerances to cover residues in or on imported strawberries or stone fruits. On May 31, 2000, BASF Corporation requested that EPA revoke the import tolerances for cucumbers and bell peppers, as part of a risk mitigation proposal designed to address dietary and aggregate risk concerns identified during reregistration review. BASF requested that EPA revoke the established import tolerances for bell peppers and cucumbers not before January 1, 2001. These mitigation measures allowed the Agency to determine that the use of vinclozolin, with the amendments proposed by the registrant, would meet the safety standard of the Food Quality Protection Act ( FQPA). Vinclozolin is not registered for use on bell peppers and cucumbers in the United States. No person has provided comment identifying a need for EPA to retain the tolerances to cover residues in or on imported cucumbers or bell peppers. B. What is the Agency's Authority for Taking this Action? It is EPA's general practice to propose revocation of tolerances for residues of pesticide active ingredients on crop uses for which FIFRA registrations no longer exist. EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States. Nonetheless, EPA will establish and maintain tolerances even when corresponding domestic uses are canceled if the tolerances, which EPA refers to as `` import tolerances,'' are necessary to allow importation into the United States of food containing such pesticide residues. However, where there are no imported commodities that require these import tolerances, the Agency believes it is appropriate to revoke tolerances for unregistered pesticides in order to prevent potential misuse. VerDate May< 23> 2002 00: 52 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 12JNR1. SGM pfrm17 PsN: 12JNR1 40187 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Rules and Regulations C. When do These Actions Become Effective? These actions become effective on June 12, 2002. Any commodities listed in the regulatory text of this document that are treated with vinclozolin, and that are in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408( l)( 5), the `` channels of trade provision'' as established by the FQPA. Under this section, any residue of vinclozolin in or on such commodities shall not render the commodities adulterated so long as it is shown to the satisfaction of FDA that, ( 1) the residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA, and ( 2) the residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from a tolerance. The channels of trade provision allows for the orderly marketing of foods that may currently contain legal residues resulting from lawful applications of vinclozolin. D. What Action is FDA Taking with Respect to the Tolerance Revocation? The FDA in a related notice published elsewhere in this issue of the Federal Register is announcing the availability of a guidance document presenting FDA's policy on its planned enforcement approach for foods containing vinclozolin residues. This guidance will assist firms in understanding the types of showing under section 408( l)( 5) of the FFDCA that FDA may find satisfactory in accordance with its planned enforcement approach for such section. E. What is the Contribution to Tolerance Reassessment? By law, EPA is required to reassess 66% or about 6,400 of the tolerances in existence on August 2, 1996, by August 2002. EPA is also required to assess the remaining tolerances by August, 2006. As of May 15, 2002, EPA has reassessed over 4,570 tolerances. This document revokes four vinclozolin tolerances; however, the reassessments were previously counted in 1997 when all vinclozolin tolerances were reassessed in order to make a decision on a new tolerance petition. Consequently, no further vinclozolin reassessments, including these four revocations, count towards the August, 2002 review deadline of FFDCA section 408( q), as amended by the Food Quality Protection Act ( FQPA) of 1996. III. Objections and Hearing Requests A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP 2002 0036 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before August 12, 2002. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 202) 260 4865. 2. Objection/ hearing fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305 5697, by e­ mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit III. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 2. Mail your copies, identified by docket ID number OPP 2002 0036, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 2. You may also send an electronic copy of your request via e­ mail to: oppdocket epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries. B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested ( 40 CFR 178.32). IV. Regulatory Assessment Requirements This final rule will revoke tolerances established under FFDCA section 408. VerDate May< 23> 2002 00: 52 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 12JNR1. SGM pfrm17 PsN: 12JNR1 40188 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Rules and Regulations The Office of Management and Budget ( OMB) has exempted this type of action ( i. e., a tolerance revocation for which extraordinary circumstances do not exist) from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866 due to its lack of significance, this final rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104 4). Nor does it require any special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and LowIncome Populations ( 59 FR 7629, February 16, 1994); or OMB review or any other Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104 113, section 12( d) ( 15 U. S. C. 272 note). Pursuant to the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.), the Agency previously assessed whether revocations of tolerances might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. This analysis was published on December 17, 1997 ( 62 FR 66020), and was provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, and available information concerning the pesticides listed in this rule, I certify that this action will not have a significant economic impact on a substantial number of small entities. Specifically, as per the 1997 notice, EPA has reviewed its available data on imports and foreign pesticide usage and concludes that there is a reasonable international supply of food not treated with canceled pesticides. Furthermore, the Agency knows of no extraordinary circumstances that exist as to the present revocations that would change EPA's previous analysis. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408( n)( 4). For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. V. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule'' as defined by 5 U. S. C. 804( 2). VerDate May< 23> 2002 00: 52 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 12JNR1. SGM pfrm17 PsN: 12JNR1 40189 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Rules and Regulations List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 20, 2002. Marcia E. Mulkey, Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180 [ AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U. S. C. 321( q), 346( a) and 371. 2. Section 180.[ 380] is amended by removing from the table in paragraph ( a) the entries for `` cucumbres'', `` peppers ( bell)'', `` stonefruits, except plums/ fresh prunes'' and `` strawberries'', and by adding paragraph ( e) to read as follows: § 180.380 Vinclozolin; tolerances for residues. * * * * * ( e) Revoked tolerances subject to the channel of trade provisions. The following table lists commodities with residues of vinclozolin resulting from lawful use are subject to the channels of trade provisions of section 408( l)( 5) of the FFDCA: Commodity Parts per million Cucumbers 1.0 Peppers ( bell) 3.0 Stonefruits, except plums/ fresh prunes 25.0 Strawberries 10.0 [ FR Doc. 02 13520 Filed 6 11 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP 2002 0082; FRL 7180 8] Triflusulfuron Methyl; Pesticide Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of triflusulfuron methyl in or on beet, sugar, roots; beet, sugar, tops; and chicory, roots. Interregional Research Project # 4 ( IR­ 4) and E. I. Dupont de Nemours & Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act of 1996 ( FQPA). DATES: This regulation is effective June 12, 2002. Objections and requests for hearings, identified by docket ID number OPP 2002 0082, must be received on or before August 12, 2002. ADDRESSES: Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket ID number OPP 2002 0082 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: James A. Tompkins or Hoyt Jamerson, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 305 5697 or ( 703) 308 9368; e­ mail address: tompkins. jim@ epa. gov or jamerson. hoyt@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: TABLE 1. EXAMPLES OF POTENTIALLY AFFECTED ENTITIES Categories NAICS codes Examples of potentially affected entities Industry 111 112 311 32532 Crop production Animal production Food manufacturing Pesticide manufacturing This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the persons listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations,'' `` Regulations and Proposed Rules,'' and then look up the entry for this document under the `` Federal Register Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http:// www. epa. gov/ opptsfrs/ home/ guidelin. htm. 2. In person. The Agency has established an official record for this action under docket ID number OPP 2002 0082. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805. II. Background and Statutory Findings In the Federal Register of December 22, 1999 ( 64 FR 71760) ( FRL 6391 1) and August 8, 2001 ( 66 FR 41593) ( FRL 6795 4), EPA issued a notice pursuant to section 408 of FFDCA, 21 U. S. C. 346a, as amended by FQPA ( Public Law 104 170), announcing the filing of a pesticide petition ( PP) by IR­ 4 and E. I. Dupont de Nemours & Company, 681 US Highway # 1 South North Brunswick, NJ 08902 3390, and E. I. DuPont de VerDate May< 23> 2002 00: 52 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 12JNR1. SGM pfrm17 PsN: 12JNR1

epa

2024-06-07T20:31:41.512528

regulations

EPA-HQ-OPP-2002-0037-0001

Rule

Pesticides; Removal of Duplicative or Expired Time-Limited Tolerances for Emergency Exemptions

[ Federal Register: May 17, 2002 ( Volume 67, Number 96)] [ Rules and Regulations] [ Page 35045­ 35050] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr17my02­ 9] ===================================================================== == ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP­ 2002 ­ 0037; FRL­ 6835­ 7] RIN 2070­ AB78 Pesticides; Removal of Duplicative or Expired Time­ limited Tolerances for Emergency Exemptions AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ SUMMARY: EPA is amending 40 CFR part 180 to remove time­ limited tolerances for several pesticides that were originally established to support emergency exemptions issued under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA). These time­ limited tolerances are being removed from 40 CFR part 180 because they have since expired or because permanent tolerances have been established for the pesticide and commodity covered by the time­ limited tolerance. The expired time­ limited tolerance is obsolete, while the unexpired time­ limited tolerance covered by a permanent tolerance is duplicative. In either case, the time­ limited tolerance is unnecessary and is being removed with this final rule to ensure that the regulatory listings of tolerances is properly updated. DATES: This rule is effective May 17, 2002. Objections and requests for hearings, identified by docket control number OPP­ 2002­ 0037, must be received by EPA on or before July 16, 2002. ADDRESSES: Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit I. C. of the " SUPPLEMENTARY INFORMATION" section. To ensure proper receipt by EPA, your objections and hearing requests must identify docket control number OPP­ 2002­ 0037 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: Robert Forrest, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 308­ 9376; and e­ mail address: forrest. robert@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Examples of Potentially Categories NAICS Affected Entities ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select " Laws and Regulations," " Regulations and Proposed Rules," and then look up the entry for this document under the " Federal Register& mdash;­ Environmental Documents." You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. 2. In person. The Agency has established an official record for this action under docket control number OPP­ 2002­ 0037. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305­ 5805. C. How Can I Submit an Objection or Request a Hearing Under FFDCA? Although section 408( g) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act ( FQPA), allows any person to file an objection or request a hearing when the Agency issues a final tolerance action under section 408, EPA does not expect that anyone will file an objection or request a hearing for this particular rule because the tolerances being revoked here are unnecessary duplicates of a permanent tolerance that remains in place or are obsolete by their own terms. If, for some reason, anyone wishes to file an objection or request for a hearing under section 408( g), please follow the EPA procedural regulations which govern the submission of objections and requests for hearings that appear in 40 CFR part 178. Note that the period for filing objections is now 60 days, rather than 30 days. II. Authority A. What is EPA's Authority for Revoking these Tolerances? This final rule is issued pursuant to section 408( e) of FFDCA, as amended by the FQPA ( 21 U. S. C. 346a( e)). Section 408 of FFDCA authorizes the establishment of tolerances, exemptions from the requirement of a tolerance, modifications in tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods. Without a tolerance or tolerance exemption, food containing pesticide residues is considered to be unsafe and therefore " adulterated" under section 402( a) of the FFDCA. If food containing pesticide residues is found to be adulterated, the food may not be [[ Page 35046]] distributed in interstate commerce ( 21 U. S. C. 331( a) and 342( a)). B. Why is EPA Issuing this as a Final Rule? Section 553 of the Administrative Procedure Act, 5 U. S. C. 553( b)( B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making today's rule final without prior proposal and opportunity for comment because the actions taken in this final rule represent technical corrections to the regulations and do not involve substantive Agency action. The removal of an expired time­ limited tolerance from 40 CFR part 180 represents a simple correction of the regulations, and does not involve any substantive Agency action. The expiration date for the time­ limited tolerance is set when the Agency issues the final rule that originally establishes, or a subsequent final rule that amends, the specific time­ limited tolerance. Once that time­ limited tolerance expires, the associated listing in 40 CFR part 180 is obsolete and must be removed to reflect that expiration. The revocation of an unexpired time­ limited tolerance from 40 CFR part 180, however, represents a substantive Agency action. In this case, that action is appropriate because the Agency's subsequent establishment of a permanent tolerance for the same pesticide chemical and commodity that was covered by the time­ limited tolerance, causes the time­ limited tolerance to become obsolete. Although the time­ limited tolerance would expire by its own terms and become obsolete, the Agency is removing these tolerances today to eliminate an unnecessary duplication in the regulations. For these reasons, notice and public procedure are unnecessary. EPA finds that this constitutes good cause under 5 U. S. C. 553( b)( B). III. Overview of Today's Action A. What Action is EPA Taking? For each pesticide chemical and commodity combination listed below, EPA previously established a time­ limited tolerance, under section 408 of the FFDCA, 21 U. S. C. 346a, as amended by the FQPA of 1996 ( Public Law 104­ 170). EPA established the tolerances because section 408( l)( 6) of the FFDCA requires EPA to establish a time­ limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. These time­ limited tolerances are being removed from 40 CFR part 180 today because they have since expired or because permanent tolerances have since been established making these time­ limited tolerances obsolete or unnecessary. B. Which Time­ Limited Tolerances are Obsolete? The time­ limited tolerances for the following pesticide chemicals on specific commodities are being removed from 40 CFR part 180 because the time­ limited tolerances have expired, or are duplicative of a permanent tolerance that the Agency subsequently established for the pesticide and commodity covered by the time­ limited tolerance. In either case, the time­ limited tolerance is obsolete and no longer necessary: 1. Avermectin. The time­ limited tolerance for celeriac is being removed from 40 CFR 180.449 because a permanent tolerance for the same pesticide chemical and commodity has been established. 2. Azoxystrobin. Time­ limited tolerances for aspirated soybean grain fractions; cucurbits; eggs; kidney of cattle; kidney of goats, hogs, and sheep grazed on sugar beets; leaf and head lettuce; liver of cattle, goat, horse, sheep, hog, and poultry; meat and fat of cattle, goat, horse, sheep, poultry and swine; milk; dried and fresh parsley; rice grain; rice hulls; rice straw; soybean meal; soybean oil; soybean silage; spinach; sugar beet roots; sugar beet tops; sugar beet molasses; dried sugar beet pulp; refined sugar of sugar beet; and strawberries; are being removed from 40 CFR 180.507 because they expired on or before December 30, 2001. The time­ limited tolerance for watercress is being removed from 40 CFR part 180 because a permanent tolerance for the same pesticide chemical and commodity has been established. 3. Bentazon. The time­ limited tolerance for succulent peas is being removed from 40 CFR 180.355 because it expired on December 31, 2000. 4. Bifenthrin. Time­ limited tolerances for broccoli; cabbage; canola seed; cauliflower; grapes; raspberries; and cucurbit vegetables are being removed from 40 CFR 180.442 because they expired on or before December 31, 2001. 5. Carfentrazone­ ethyl. Time­ limited tolerances for rice grain and rice straw are being removed from 40 CFR 180.515 because they expired on December 31, 2000. 6. Chlorfenapyr. Time­ limited tolerances for fat; meat byproducts and meat of cattle, goats, hogs, horses and sheep; cottonseed; cotton gin byproducts; milk; and milk fat are being removed from 40 CFR 180.513 because they expired on January 31, 2001. 7. Clomazone. Time­ limited tolerances for rice grain, rice straw, sugarcane and watermelons are being removed from 40 CFR 180.425 because permanent tolerances for the same pesticide chemical and commodities have been established. 8. Cymoxanil. The time­ limited tolerance for tomatoes is being removed from 40 CFR 180.503 because it expired on May 15, 1999. 9. Cyprodinil. The time­ limited tolerance for strawberries is being removed from 40 CFR 180.532 because it expired on May 31, 2001. 10. Dicloran. Time­ limited tolerances for peanut oil and peanuts are being removed from 40 CFR 180.200 because they expired on October 31, 2001. 11. Diflubenzuron. The time­ limited tolerance for pears is being removed from 40 CFR 180.377 because it expired on March 31, 2001. 12. Dimethomorph. Time­ limited tolerances for potatoes, tomatoes, tomato paste, and tomato puree are being removed from 40 CFR 180.493 because they expired on or before September 15, 2000. 13. Endothall. The time­ limited tolerance for canola seed is being removed from 40 CFR 180.293 because it expired on February 29, 2000. 14. Ethametsulfuron­ methyl. The time­ limited tolerance for canola is being removed from 40 CFR 180.563 because a permanent tolerance for the same pesticide chemical and commodity has been established. 15. Fenarimol. Time­ limited tolerances for filberts and hops are being removed from 40 CFR 180.421 because they expired on December 31, 1998. 16. Fenoxycarb. The time­ limited tolerance for pears is being removed from 40 CFR 180.504 because it expired on April 30, 1998. 17. Fenpropathrin. Time­ limited tolerances for soybean forage, soybean hay, soybean hulls, soybean meal, refined soybean oil, and soybean seed are being removed from 40 CFR 180.466 because they expired on December 31, 2001. 18. Fludioxonil. The time­ limited tolerance for strawberry is being removed from 40 CFR 180.516 because it expired on May 31, 2001. 19. Glyphosate. Time­ limited tolerances for kidney of cattle, goats, [[ Page 35047]] horses, and sheep; chickpeas; lentils; pea hay; pea vines; dry peas and silage hay are being removed from 40 CFR 180.364 because they expired on February 29, 2000. 20. Imidacloprid. Time­ limited tolerances for citrus fruits crop group; dried citrus pulp; field corn forage; field corn stover ( fodder); field corn grain; sweet corn fodder; sweet corn forage; sweet corn grain and cucurbits vegetable are being removed from 40 CFR 180.472 because permanent tolerances for the same pesticide chemical and commodities have been established. 21. Lambda­ cyhalothrin. Time­ limited tolerances for canola seed and flax seed are being removed from 40 CFR 180.438 because they expired on December 31, 2000. 22. Maleic hydrazide. Time­ limited tolerances for fat, liver, kidney, and meat of cattle, goats, hogs, horses, poultry, and sheep; eggs; milk; rice bran; rice grain; rice hulls; and rice straw are being removed from 40 CFR 180.175 because they expired on September 30, 2000. 23. Mefenoxam. The time­ limited tolerance for canola is being removed from 40 CFR 180.546 because it expired on December 31, 2001. 24. Myclobutanil. Time­ limited tolerances for asparagus; caneberries; cucurbit vegetables; peppermint; spearmint; strawberries; tomato fruit; tomato paste; and tomato puree are being removed from 40 CFR 180.443 because they expired on or before December 31, 2000. 25. Oxyfluorfen. The time­ limited tolerance for strawberries is being removed from 40 CFR 180.381 because it expired on April 15, 2001. 26. Paraquat. The time­ limited tolerance for artichokes is being removed from 40 CFR 180.205 because a permanent tolerance for the same pesticide chemical and commodity has been established. Time­ limited tolerances for mustard seed; poultry meat by­ products; aspirated grain fractions of sorghum; sorghum forage; sorghum grain; and sorghum stover are being removed from 40 CFR 180.205 because they expired on or before November 15, 1998. 27. Primisulfuron­ methyl. The time­ limited tolerance for bluegrass hay is being removed from 40 CFR 180.452 because it expired on April 30, 2000. 28. Propamocarb hydrochloride. Time­ limited tolerances for potatoes; fat, meat, meat by­ product of cattle, goats, hogs, horse and sheep; milk are being removed from 40 CFR 180.499 because they expired on September 15, 2000. 29. Propiconazole. Time­ limited tolerances for almond hull and almond nut meat are being removed from 40 CFR 180.434 because they expired on July 31, 2000. 30. Propyzamide. Time­ limited tolerances for grass forage and grass hay are being removed from 40 CFR 180.317 because they expired on December 31, 2001. 31. Pyridate. Time­ limited tolerances for peppermint tops ( leaves and stems) and spearmint tops ( leaves and stems) are being removed from 40 CFR 180.462 because they expired on December 31, 2001. 32. Pyriproxyfen. Time­ limited tolerances for almond hulls, almond nutmeats, citrus fruit, citrus juice, citrus oil, dried citrus pulp, pears, and tomatoes are being removed from 40 CFR 180.510 because permanent tolerances for the same pesticide chemical and commodities have been established. 33. Quinclorac. Time­ limited tolerances for fat and meat byproducts of cattle, goats, hogs, horses, and sheep; poultry fat; sorghum grain fodder ( stover); sorghum grain forage; sorghum grain; aspirated grain fractions of wheat; wheat forage; wheat grain; milled wheat fractions; and wheat straw are being removed from 40 CFR 180.463 because they expired on May 30, 2000. 34. Sethoxydim. Time­ limited tolerances for buckwheat and horseradish are being removed from 40 CFR 180.412 because they expired on or before December 31, 2001. 35. Sodium Salt of Acifluorfen. Time­ limited tolerances for cowpeas, lima beans, and Southern peas are being removed from 40 CFR 180.383 because they expired on December 31, 1998. 36. Sodium Salt of Fomesafen. Time­ limited tolerances for snap beans and dry beans are being removed from 40 CFR 180.433 because they expired on or before October 31, 1998. 37. Tebuconazole. Time­ limited tolerances for pistachios; milk and meat byproducts of cattle, goats, hogs, horses, poultry and sheep are being removed from 40 CFR 180.474 because they expired on December 30, 2000. 38. Tebufenozide. Time­ limited tolerances for apple pomace; apples; fat, kidney, liver, meat byproducts and meat of cattle, goats, hogs, and sheep; horse meat; cotton gin byproducts; cottonseed hulls; cottonseed meal; cottonseed oil; undelinted cottonseed; cranberries; leafy vegetable ( Cole­ brassica); leafy vegetables ( non­ brassica); milk; pears; pecans; peppers; rice bran; rice grain; rice hulls; rice straw; soybeans; sugar beet tops; sugar beet roots; dried sugar beet pulp; sugar beet molasses; sugar beet refined sugar; sugarcane; sugarcane molasses; and turnip tops are being removed from 40 CFR 180.482 because they expired on or before December 31, 2001. 39. Thiamethoxam. Time­ limited tolerances for meat and meat byproducts of cattle, goat, horse, and sheep; undelinted cotton seed; cotton gin byproducts; and milk are being removed from 40 CFR 180.565 because permanent tolerances for the same pesticide chemical and commodities have been established. 40. Triadimefon. Time­ limited tolerances for artichokes, asparagus, and chili peppers are being removed from 40 CFR 180.410 because they expired on or before September 1, 1999. 41. Triclopyr. Time­ limited tolerances for fish and shellfish are being removed from 40 CFR 180.417 because they expired on or before June 30, 2000. IV. Regulatory Assessment Requirements This final rule removes obsolete or unnecessary time­ limited tolerances that were previously established under FFDCA section 408. The Office of Management and Budget ( OMB) has exempted tolerance actions like this revocation from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997), or Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). Because the agency has made a good cause finding that this action is not subject to notice­ and­ comment requirements under the Administrative Procedure Act or any other statute ( see discussion in Unit II. B. of this preamble), it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act ( RFA)( 5 U. S. C. 601 et seq.), or to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 ( UMRA)( Public Law 104­ 4). In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of UMRA. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408( n)( 4). This action will not have substantial direct effects [[ Page 35048]] on State or tribal governments, on the relationship between the Federal government and States or Indian tribes, or on the distribution of power and responsibilities between the Federal government and States or Indian tribes. As a result, this action does not require any action under Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999), or under Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Nor does it require special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low­ Income Populations ( 59 FR 7629, February 16, 1994); or Executive Order 12630, entitled Governmental Actions and Interference with Constitutionally Protected Property Rights ( 53 FR 8859, March 15, 1988). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104­ 113, section 12( d) ( 15 U. S. C. 272 note). This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act ( PRA)( 44 U. S. C. 3501 et seq.). In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988 ( 61 FR 4729, February 7, 1996). V. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U. S. C. 808( 2). As stated in Unit II. B. of this preamble, EPA has made such a good cause finding for this rule, including the reasons therefor, and established an effective date of May 17, 2002. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a " major rule" as defined by 5 U. S. C. 804( 2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: April 26, 2002. Donald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180& mdash;[ AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U. S. C. 321( q), 346( a) and 374. Sec. 180.175 [ Amended] 2. In Sec. 180.175, the text of paragraph ( b) following the paragraph heading is removed and reserved. Sec. 180.200 [ Amended] 3. In Sec. 180.200, the text of paragraph ( b) following the paragraph heading is removed and reserved. Sec. 180.205 [ Amended] 4. In Sec. 180.205, the text of paragraph ( b) following the paragraph heading is removed and reserved. Sec. 180.293 [ Amended] 5. In Sec. 180.293, the text of paragraph ( b) following the paragraph heading is removed and reserved. Sec. 180.317 [ Amended] 6. In Sec. 180.317, in the table in paragraph ( b), remove the entries grass, forage and grass, hay. Sec. 180.355 [ Amended] 7. In Sec. 180.355, the text of paragraph ( b) following the paragraph heading is removed and reserved. Sec. 180.364 [ Amended] 8. In Sec. 180.364, the text of paragraph ( b) following the paragraph heading is removed and reserved. Sec. 180.377 [ Amended] 9. In Sec. 180.377, the text of paragraph ( b) following the paragraph heading is removed and reserved. Sec. 180.381 [ Amended] 10. In Sec. 180.381, the text of paragraph ( b) following the paragraph heading is removed and reserved. Sec. 180.383 [ Amended] 11. In Sec. 180.383, the text of paragraph ( b) following the paragraph heading is removed and reserved. Sec. 180.410 [ Amended] 12. In Sec. 180.410, the text of paragraph ( b) following the paragraph heading is removed and reserved. Sec. 180.412 [ Amended] 13. In Sec. 180.412, in the table in paragraph ( b), remove the entries buckwheat and horseradish. Sec. 180.417 [ Amended] 14. In Sec. 180.417, the text of paragraph ( b) following the paragraph heading is removed and reserved. Sec. 180.421 [ Amended] 15. In Sec. 180.421, the text of paragraph ( b) following the paragraph heading is removed and reserved. Sec. 180.425 [ Amended] 16. In Sec. 180.425, the text of paragraph ( b) following the paragraph heading is removed and reserved. Sec. 180.433 [ Amended] 17. In Sec. 180.433, the text of paragraph ( b) following the paragraph heading is removed and reserved. Sec. 180.434 [ Amended] 18. In Sec. 180.434, in the table in paragraph ( b), remove the entries for " Almond hull" and " Almond nut meat". Sec. 180.438 [ Amended] 19. In Sec. 180.438, in the table in paragraph ( b), remove the entries for " Canola, seed" and " Flax, seed". 20. In Sec. 180.442, the table in paragraph ( b) is revised to read as follows: Sec. 180.442 Bifenthrin; tolerances for residues. * * * * * ( b) * * * ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Expiration/ Commodity Parts per revocation million date ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Citrus..................................... 0.05 12/ 31/ 02 Citrus, dried pulp......................... 0.3 12/ 31/ 02 Citrus, oil................................ 0.3 12/ 31/ 02 Peanut..................................... 0.05 12/ 31/ 03 Potato..................................... 0.05 12/ 31/ 02 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ * * * * * [[ Page 35049]] 21. In Sec. 180.443, the table in paragraph ( b) is revised to read as follows: Sec. 180.443 Myclobutanil; tolerances for residues. * * * * * ( b) * * * ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Expiration/ Commodity Parts per revocation million date ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Artichoke, globe........................... 1.0 6/ 30/ 03 Beet, sugar, dried pulp.................... 1.0 12/ 31/ 02 Beet, sugar, molasses...................... 1.0 12/ 31/ 02 Beet, sugar, refined sugar................. 0.70 12/ 31/ 02 Beet, sugar, roots......................... 0.05 12/ 31/ 02 Beet, sugar, tops.......................... 1.0 12/ 31/ 02 Hop, dried cones........................... 5.0 12/ 31/ 03 Pepper..................................... 1.0 6/ 30/ 03 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ * * * * * Sec. 180.449 [ Amended] 22. In Sec. 180.449, in the table in paragraph ( b), remove the entry for " Celeriac". Sec. 180.452 [ Amended] 23. In Sec. 180.452, the text of paragraph ( b) following the paragraph heading is removed and reserved. Sec. 180.462 [ Amended] 24. In Sec. 180.462, the text of paragraph ( b) following the paragraph heading is removed and reserved. Sec. 180.463 [ Amended] 25. In Sec. 180.463, the text of paragraph ( b) following the paragraph heading is removed and reserved. 26. In Sec. 180.466, the table in paragraph ( b) is revised to read as follows: Sec. 180.466 Fenpropathrin; tolerances for residues. * * * * * ( b) * * * ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Expiration/ Commodity Parts per revocation million date ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Currant....................................... 15 12/ 31/ 03 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ * * * * * 27. In Sec. 180.472, the table in paragraph ( b) is revised to read as follows: Sec. 180.472 Imidacloprid; tolerances for residues. * * * * * ( b) * * * ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Expiration/ Commodity Parts per revocation million date ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Almond..................................... 0.05 12/ 31/ 03 Almond, hulls.............................. 4.0 12/ 31/ 03 Blueberry.................................. 1.0 12/ 31/ 03 Cranberry.................................. 0.5 12/ 31/ 03 Plum, prune................................ 10.0 12/ 31/ 03 Stone fruit................................ 3.0 12/ 31/ 03 Strawberry................................. 0.1 6/ 30/ 02 Vegetable, legume.......................... 1.0 6/ 30/ 02 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ * * * * * Sec. 180.474 [ Amended] 28. In Sec. 180.474, in the table in paragraph ( b)( 1), remove the entry for " Pistachios", remove paragraph ( b)( 1) paragraph heading, redesignate paragraph ( b)( 1) as paragraph ( b), and remove paragraph ( b)( 2). 29. In Sec. 180.482, the table in paragraph ( b) is revised to read as follows: Sec. 180.482 Tebufenozide; tolerances for residues. * * * * * ( b) * * * ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Expiration/ Commodity Parts per revocation million date ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Beet, garden, roots........................ 0.3 12/ 31/ 02 Beet, garden, tops......................... 9.0 12/ 31/ 02 Egg........................................ 0.01 6/ 30/ 03 Grape...................................... 3.0 12/ 31/ 03 Grass, forage.............................. 5 6/ 30/ 03 Grass, hay................................. 18 6/ 30/ 03 Longan..................................... 1.0 12/ 31/ 03 Lychee..................................... 1.0 12/ 31/ 03 Peanut..................................... 0.05 6/ 30/ 03 Peanut, hay................................ 5 6/ 30/ 03 Peanut, meal............................... 0.15 6/ 30/ 03 Peanut, refined oil........................ 0.15 6/ 30/ 03 Poultry, fat............................... 0.1 6/ 30/ 03 Poultry, meat.............................. 0.01 6/ 30/ 03 Poultry, meat byproducts................... 0.05 6/ 30/ 03 Sunflower, seed............................ 1.5 12/ 31/ 02 Sweet potato, roots........................ 0.25 12/ 31/ 02 Vegetable, foliage of legume, group........ 7.0 12/ 31/ 02 Vegetable, legume, group................... 2.0 12/ 31/ 02 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ * * * * * Sec. 180.493 [ Amended] 30. In Sec. 180.493, in the table to paragraph ( b), remove the entries for " Potatoes", " Tomatoes", " Tomato paste", and " Tomato puree". 31. In Sec. 180.499, the table in paragraph ( b) is revised to read as follows: Sec. 180.499 Propamocarb hydrochloride; tolerances for residues. * * * * * ( b) * * * ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Parts per Expiration/ Commodity million revocation date ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Tomato.................................. 2.0 12/ 31/ 03 Tomato, paste........................... 5.0 12/ 31/ 03 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ * * * * * Sec. 180.503 [ Amended] 32. In Sec. 180.503, in the table in paragraph ( b), remove the entry for " Tomatoes." Sec. 180.504 [ Removed and Reserved] 33. Section 180.504, is removed and reserved. 34. In Sec. 180.507, the table in paragraph ( b) is revised to read as follows: Sec. 180.507 Azoxystrobin; tolerances for residues. * * * * * ( b) * * * ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Expiration/ Commodity Parts per revocation million date ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Brassica, head and Stem, subgroup.......... 30 12/ 31/ 03 Chickpea, seed............................. 0.5 12/ 31/ 03 Lychee..................................... 3.0 12/ 31/ 03 Pepper..................................... 2.0 12/ 31/ 03 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ * * * * * 35. In Sec. 180.510, the table in paragraph ( b) is revised to read as follows: Sec. 180.510 Pyriproxyfen; tolerances for residues. * * * * * ( b)* * * ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Expiration/ Commodity Parts per revocation million date ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Bean, succulent............................ 0.10 6/ 30/ 03 Stone fruits ( Crop Group 12)............... 0.1 12/ 31/ 02 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ * * * * * Sec. 180.513 [ Removed and Reserved] 36. Section 180.513, is removed and reserved. [[ Page 35050]] Sec. 180.515 [ Amended] 37. In Sec. 180.515, in the table in paragraph ( b), remove the entries for " Rice, grain" and " Rice, straw". Sec. 180.516 [ Amended] 38. In Sec. 180.516, in the table in paragraph ( b), remove the entry " Strawberry". Sec. 180.532 [ Amended] 39. In Sec. 180.532, in the table to paragraph ( b), remove the entry " Strawberries". Sec. 180.546 [ Amended] 40. In Sec. 180.546, the text of paragraph ( b) following the paragraph heading is removed and reserved. Sec. 180.563 [ Amended] 41. In Sec. 180.563, the text of paragraph ( b) following the paragraph heading is removed and reserved. Sec. 180.565 [ Amended] 42. In Sec. 180.565, the text of paragraph ( b) following the paragraph heading is removed and reserved. [ FR Doc. 02­ 11742 Filed 5­ 16­ 02; 8: 45 am] BILLING CODE 6560­ 50­ S

epa

2024-06-07T20:31:41.520226

regulations

EPA-HQ-OPP-2002-0042-0001

Notice

Hydrogen Peroxide; An Amendment to an Exemption from the Requirement of a Tolerance; Technical Correction.

41843 Federal Register / Vol. 67, No. 119 / Thursday, June 20, 2002 / Rules and Regulations EPA APPROVED REGULATIONS IN THE LOUISIANA SIP State citation Title/ subject State approval date EPA approval date Comments * * * * * * * Chapter 21. Control of Emission of Organic Compounds * * * * * * * Subchapter M, Limiting Volatile Organic Compound Emissions from Industrial Wastewater Section 2153 .................. Limiting Volatile Organic Compound Emissions from Industrial Wastewater May, 1999, LR 25: 850 ...... June 20, 2002, and Federal Register citation. * * * * * * * [ FR Doc. 02 15453 Filed 6 19 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP 2002 0042; FRL 6835 3] RIN 2070 AB78 Hydrogen Peroxide; An Amendment to an Exemption From the Requirement of a Tolerance; Technical Correction AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule; technical correction. SUMMARY: In the Federal Register of February 28, 2002, EPA issued a revised exemption from the requirement of a tolerance for residues of the biochemical hydrogen peroxide. In the SUMMARY and the codified text, a phrase was inadvertently omitted. This document corrects those errors. DATES: This document is effective June 20, 2002. FOR FURTHER INFORMATION CONTACT: By mail: Diana Hudson, c/ o Product Manager ( PM) 90, Biopesticides and Pollution Prevention Division ( 7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number ( 703) 308 8713; and e­ mail address: hudson. diana@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does This Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: Categories NAICS codes Examples of potentially affected entities Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of This Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations,'' `` Regulations and Proposed Rules,'' and then look up the entry for this document under the `` Federal Register Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 180/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. 2. In person. The Agency has established an official record for this action under docket control number OPP 2002 0042. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805. II. Background A. What Does This Technical Correction Do? In the Federal Register of February 28, 2002 ( 67 FR 9214) ( FRL 6822 7), EPA revised an exemption from the requirement of a tolerance for residues of the biochemical hydrogen peroxide. In the SUMMARY and the codified text, a phrase was inadvertently omitted. This document corrects those errors. On page 9214, third column, the first sentence of the summary is corrected to read as follows: `` This regulation establishes an amendment to an exemption from the requirement of a tolerance for residues of the biochemical hydrogen peroxide in or on all food commodities when applied/ used at the rate of 1% hydrogen peroxide per VerDate jun< 06> 2002 16: 51 Jun 19, 2002 Jkt 197001 PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 20JNR1. SGM pfrm15 PsN: 20JNR1 41844 Federal Register / Vol. 67, No. 119 / Thursday, June 20, 2002 / Rules and Regulations application on growing and postharvest crops.'' The codified text is corrected in the regulatory text of this document. B. Why is This Technical Correction Issued as a Final Rule? Section 553 of the Administrative Procedure Act ( APA), 5 U. S. C. 553( b)( B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making today's technical correction final without prior proposal and opportunity for comment, because EPA is merely adding a phrase that was inadvertently omitted from the previously published final rule. EPA finds that this constitutes good cause under 5 U. S. C. 553( b)( B). III. Regulatory Assessment Requirements This final rule implements a technical amendment to the Code of Federal Regulations, and it does not otherwise impose or amend any requirments. As such, the Office of Management and Budget ( OMB) has determined that a technical correction is not a `` significant regulatory action'' subject to review by OMB under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104 4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low­ Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104 113, section 12( d) ( 15 U. S. C. 272 note). Since this action does not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408( n)( 4). For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. IV. Submission to Congress and the Comptroller General? The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule'' as defined by 5 U. S. C. 804( 2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: June 7, 2002. Janet L. Andersen. Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180 [ AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U. S. C. 321( q), 346( a) and 374. 2. Section 180.1197 is revised to read as follows: 180.1197 Hydrogen peroxide; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of hydrogen peroxide in or on all food commodities at the rate of 1% hydrogen peroxide per application on growing and postharvest crops. [ FR Doc. 02 15618 Filed 6 19 02; 8: 45 am] BILLING CODE 6560 50 S VerDate jun< 06> 2002 16: 51 Jun 19, 2002 Jkt 197001 PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 20JNR1. SGM pfrm15 PsN: 20JNR1

epa

2024-06-07T20:31:41.525381

regulations

EPA-HQ-OPP-2002-0043-0001

Rule

Pesticide Tolerance Nomenclature Changes; Technical Amendment (FRL-6835-2)

Wednesday, June 19, 2002 Part VI Environmental Protection Agency 40 CFR Part 180 Pesticide Tolerance Nomenclature Changes; Technical Amendment; Final Rule VerDate May< 23> 2002 10: 51 Jun 18, 2002 Jkt 197001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\ FR\ FM\ 19JNR2. SGM pfrm17 PsN: 19JNR2 41802 Federal Register / Vol. 67, No. 118 / Wednesday, June 19, 2002 / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP 2002 0043; FRL 6835 2] Pesticide Tolerance Nomenclature Changes; Technical Amendment AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule; technical amendment. SUMMARY: This document makes minor revisions to the terminology of certain commodity terms listed under 40 CFR part 180, subpart C. EPA is taking this action to establish a uniform listing of the commodity terms. DATES: This document is effective June 19, 2002. FOR FURTHER INFORMATION CONTACT: By mail: Hoyt L. Jamerson, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 308 9368; and e­ mail address: jamerson. hoyt@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: Categories NAICS codes Examples of potentially affected entities Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations,'' `` Regulations and Proposed Rules,'' and then look up the entry for this document under the `` Federal Register Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 180/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. To access an electronic copy of the commodity data base entitled Food and Feed Commodity Vocabulary go to: http:// www. epa. gov/ pesticides/ foodfeed/. 2. In person. The Agency has established an official record for this action under docket control number OPP 2002 0043. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805. II. Background A. What Does this Technical Amendment Do? EPA's Office of Pesticide Programs ( OPP) has developed a commodity vocabulary data base entitled Food and Feed Commodity Vocabulary. The data base was developed to consolidate all the major OPP commodity vocabularies into one standardized vocabulary. As a result, all future pesticide tolerances issued under 40 CFR part 180 will use the `` preferred commodity term'' as listed in the aforementioned data base. This final rule is the first in a series of documents revising the terminology of commodity terms listed under 40 CFR part 180. This revision process will establish a uniform presentation of existing commodity terms under 40 CFR part 180. In this rule, EPA is making the following format changes to the terminology of commodity terms in 40 CFR part 180 to the extent the terminology is not already in this format: 1. The first letter of the commodity term is capitalized. All other letters, including the first letter of proper names, are changed to lower case. 2. Commodity terms are listed in the singular although there are the following exceptions: including the terms `` leaves'', `` roots'', `` tops'', `` greens'', `` hulls'', `` vines'', `` fractions'', `` shoots'', and `` byproducts''. 3. Hyphens are removed from commodity terms. Example ­ `` Cattle, meat by­ products'' is revised to read `` Cattle, meat byproducts''. 4. Commodity terms are amended so that generic terms, such as `` corn'', `` pea'', `` cattle'', precede modifying terms, such as `` field'', `` dry'', `` summer''. Examples ­ `` Corn, field''; `` Pea, dry''; and `` Squash, summer'', not `` field corn'', `` dry pea'', or `` Summer squash''. 5. Abbreviated terms are replaced with the appropriate commodity terms. Examples ­ `` Hog MBYP'' is replaced with `` hog, meat byproducts''. K+ CWHR is replaced with `` kernal plus cob with husks removed''. 6. Parenthesis are replaced with commas. Example ­ `` Cattle meat byproducts ( except kidney)'' is replaced with `` Cattle, meat byproducts, except kidney''. 7. Combined commodity entries are listed separately. Examples ­ `` Goat, kidney and liver'' is revised to read as follows: `` Goat, kidney'', and `` Goat, liver''. `` Fat of cattle, goat, horse and sheep'' is revised to read as follows: `` Cattle, fat'', `` Goat, fat'', `` Horse, fat;'', `` Sheep, fat'' 8. Crop group terms are revised to standardize with the `` Food and Feed Vocabulary''. Examples: i. `` Stonefruit group'' is revised to read `` Fruit, stone, group''. ii. `` Cucurbit Vegetables Crop Group'' is revised to read `` Vegetable, cucurbit, group''. iii. `` Brassica ( cole) leafy vegetables'' is revised to read `` Vegetable, brassica leafy, group''. VerDate jun< 06> 2002 19: 38 Jun 18, 2002 Jkt 197001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 19JNR2. SGM pfrm15 PsN: 19JNR2 41803 Federal Register / Vol. 67, No. 118 / Wednesday, June 19, 2002 / Rules and Regulations B. Why is this Technical Amendment Issued as a Final Rule? Section 553 of the Administrative Procedure Act ( APA), 5 U. S. C. 553( b)( B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making today's technical amendment final without prior proposal and opportunity for comment, because today's action revises commodity terms listed under 40 CFR part 180, subpart C, in a manner that clearly will have no impact on the meaning of the tolerance regulations. For example, today's action revises commodity terms so that most are in singular ( e. g., `` peach'') instead of the plural ( e. g., `` peaches''). A complete description of the types of changes that are being made has been provided above. EPA has determined that there is no need to public comment on such ministerial changes and thus that there is good cause under 5 U. S. C. 553( b)( B) for dispensing with public comment. While EPA believes that it has correctly identified all instances where these above­ listed revisions need to be made, the Agency would appreciate readers notifying EPA of discrepancies, omissions, or technical problems by submitting them to the address or e­ mail under FOR FURTHER INFORMATION CONTACT. These will be corrected in a future rule. III. Regulatory Assessment Requirements This final rule implements technical amendments to the Code of Federal Regulations which have no substantive impact on the underlying regulations, and it does not otherwise impose or amend any requirements. As such, the Office of Management and Budget ( OMB) has determined that a technical amendment is not a `` significant regulatory action'' subject to review by OMB under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104 4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low­ Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104 113, section 12( d) ( 15 U. S. C. 272 note). Since the action does not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408( n)( 4). For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. IV. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule'' as defined by 5 U. S. C. 804( 2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: June 11, 2002. Marcia Mulkey, Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180 [ AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U. S. C. 321( q), 346( a) and 374. Subpart C [ Amended] 2. In the following table, change the term exactly as it appears in the `` Existing Term'' column to read like the term in the `` New Term'' column VerDate jun< 06> 2002 20: 15 Jun 18, 2002 Jkt 197001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 19JNR2. SGM pfrm15 PsN: 19JNR2 41804 Federal Register / Vol. 67, No. 118 / Wednesday, June 19, 2002 / Rules and Regulations wherever it may appear in subpart C, and realphabetize the new term where appropriate: Existing Term New Term Alfalfa ( forage) Alfalfa, forage Alfalfa hay Alfalfa, hay Alfalfa ( hay) Alfalfa, hay Almond hull Almond, hulls Almond hulls Almond, hulls Almonds hulls Almond, hulls Almonds Almond Apples Apple Apple pomace, wet Apple, wet pomace Apple, pomace, wet Apple, wet pomace Apple pomace ( wet) Apple, wet pomace Apricots ( dried) Apricot, dried Apricots Apricot Artichokes Artichoke Avocados Avocado Bamboo shoots Bamboo, shoots Banana ( Pulp) Banana, pulp Barley ( straw) Barley, straw Barley, pearled Barley, pearled barley Bananas Banana Beans Bean Beets Beet Blackberries Blackberry Blueberries Blueberry Boysenberries Boysenberry Brazil nut Nut, brazil Bulb vegetables Vegetable, bulb, group Butternuts Butternut ( CA only) , CA only Canola meal Canola, meal Canola seed Canola, seed Cantaloupes Cantaloupe Cereal grains Grain, cereal Citrus citron Citron, citrus Existing Term New Term Citrus fruit Fruit, citrus Citrus molasses Citrus, molasses Citrus oil Citrus, oil Clover ( forage) Clover, forage Clover hay Clover, hay Clover ( hay) Clover, hay Clover, hay, for seed Clover, hay, grown for seed Cottonseed, hulls Cotton, hulls Cottonseed hulls Cotton, hulls Cottonseed soapstock Cotton, seed, soapstock Cottonseed meal Cotton, meal Cottonseed, meal Cotton, meal Cottonseed meals Cotton, meal Cottonseed, meals Cotton, meal Cottonseed, refined oil Cotton, refined oil Cranberries Cranberry Cucumbers Cucumber Currants Currant Dewberries Dewberry Eggs Egg Eggplants Eggplant ( exc. kidney and liver) , except kidney and liver ( exc. kidney, liver) , except kidney and liver ( exc. kidney) , except kidney ( exc kidney, liver) , except kidney and liver ( except kidney, liver) , except kidney and liver ( except kidney and liver) , except kidney and liver except kidney and liver , except kidney and liver ; except kidney and liver , except kidney and liver ( except kidney) , except kidney except kidney , except kidney ( except liver) , except liver Existing Term New Term except liver , except liver ( exc. liver) , except liver ( except liver and kidney) , except kidney and liver Field corn, forage Corn, field, forage Field corn, grain Corn, field, grain Field corn, stover Corn, field, stover Field, corn, forage Corn, field, forage Field, corn, grain Corn, field, grain Forage grasses Grass, forage Forage legumes Legume, forage Fruiting vegetables Vegetable, fruiting Flax straw Flax, straw ( fresh) , fresh ( fresh prune) , prune, fresh ( fresh, prunes) prune, fresh Fruits Fruit Goats Goat Grapes Grape Grasses Grass Grain crop Grain, crop Grain crops Grain, crop Grain, crops Grain, crop Gooseberries Gooseberry Grape juice Grape, juice Grape, raisins Grape, raisin Grapefruits Grapefruit Guavas Guava Hickory nuts Nut, hickory Honeydew melons Melon, honeydew Honeydews Melon, honeydew Hop cones, dried Hop, dried cone Hogs Hog Hops Hop Hop, dried Hop, dried cones Horses Horse ( hulls) , hulls Lemons Lemon VerDate May< 23> 2002 10: 51 Jun 18, 2002 Jkt 197001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 19JNR2. SGM pfrm17 PsN: 19JNR2 41805 Federal Register / Vol. 67, No. 118 / Wednesday, June 19, 2002 / Rules and Regulations Existing Term New Term Leeks Leek Legumes, forage Legume, forage Limes Lime Loganberries Loganberry Mangoes Mango Melons Melon meat by product meat byproducts meat byproduct meat byproducts meat by­ products meat byproducts ( mbyp) , meat byproducts mbyp meat byproducts Mbyp meat byproducts Mushrooms Mushroom Nectarines Nectarine Nuts Nut Olives Olive Onions ( dry bulb) Onion, dry bulb Onion, dry Onion, dry bulb Onions, bulb Onion, dry bulb Onions, green Onion, green Onions Onion Existing Term New Term Peaches Peach Pears Pear Peas Pea Peppers ( bell) Pepper, bell Peppers, non­ bell Pepper, nonbell Peppers Pepper Peppermint tops Peppermint, tops Persimmons Persimmon Pimentos Pimento Pineapple fodder Pineapple, fodder Pineapple forage Pineapple, forage Pistachios Pistachio Pomegranates Pomegranate ( POST­ H) , postharvest ( post­ h) , postharvest Potato chips Potato, chips Potatoes Potato Pumpkins Pumpkin Raspberries Raspberry ( seed) , seed ( seed treatment) , seed treatment Existing Term New Term Strawberries Strawberry Rice bran Rice, bran Rice grain Rice, grain Rice hulls Rice, hulls Rice polishings Rice, polished rice Rice straw Rice, straw Sainfoin hay Sanfoin, hay Salsify tops Salsify, tops Spearmint tops Spearmint, tops Summer squash Squash, summer Tangerines Tangerine Tomatoes Tomato Walnuts Walnut Watermelons Watermelon Youngberries Youngberry 3. In the following table change the term exactly as it appears in the `` Existing Term'' column to read like the term in the `` New Term'' column wherever it appears in subpart C, and realphabetize the new term where appropriate: Existing Term New Term Alfalfa, hay, for seed Alfalfa, hay, grown for seed Animal feed, nongrass group ( except alfalfa) Animal feed, nongrass, group, except alfalfa Bean ( succulent form) Bean, succulent Bean, snap ( succulent form) Bean, snap, succulent Brassica ( cole) leafy vegetables Vegetable, brassica, leafy, group Brassica ( cole) leafy vegetables group Vegetable, brassica, leafy, group Brassica, head and stem, subgroup, excluding cabbage Brassica, head and stem, subgroup, except cabbage Brassica, head and stem subgroup ( 5­ A) Brassica, head and stem, subgroup Brassica, head and stem, crop subgroup 5­ A Brassica, head and stem, subgroup Brassica, head and stem subgroup Brassica, head and stem, subgroup Brassica, head and stem Brassica, head and stem, subgroup Cereal Grains ( excluding sweet corn), Bran Grain, cereal, bran, except sweet corn Cereal Grains ( excluding sweet corn), Forage Grain, cereal, forage, except sweet corn Cereal Grains ( excluding sweet corn), Grain Grain, cereal, grain, except sweet corn Cereal Grains ( excluding sweet corn), Hay Grain, cereal, hay, except sweet corn VerDate May< 23> 2002 10: 51 Jun 18, 2002 Jkt 197001 PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 19JNR2. SGM pfrm17 PsN: 19JNR2 41806 Federal Register / Vol. 67, No. 118 / Wednesday, June 19, 2002 / Rules and Regulations Existing Term New Term Cereal Grains ( excluding sweet corn), Hulls Grain, cereal, hulls, except sweet corn Cereal Grains ( excluding sweet corn), Stover Grain, cereal, stover, except sweet corn Cucurbit vegetable group Vegetable, cucurbit, group Cucurbit Vegetables Crop Group Vegetable, cucurbit, group Cucurbit vegetables group Vegetable, cucurbit, group Cucurbits vegetable group Vegetable, cucurbit, group Cucurbit vegetables Vegetable, cucurbit, group Cucurbits vegetables Vegetable, cucurbit, group Citrus pulp, dehydrated Citrus, dried pulp ( K= CWHR) , kernel plus cob with husks removed ( K= kwhr) , kernel plus cob with husks removed ( K+ CWHR) , kernel plus cob with husks removed ( K + CWHR) , kernel plus cob with husks removed , K + CWHR , kernel plus cob with husks removed ( kernel plus cob with husks removed) , kernel plus cob with husks removed Oregano, Mexican, leaves Oregano, mexican, leaves Pepper, ( non­ bell1) Pepper, nonbell1 Potato waste from processing Potato, processed potato waste Root and tuber vegetables Vegetable, root and tuber, group Root and tuber vegetables group Vegetable, root and tuber, group Stone fruit crop group Fruit, stone, group Stone fruit Fruit, stone Stone fruits ( Crop Group 12) Fruit, stone, group Stone fruits group Fruit, stone, group Stonefruit group Fruit, stone, group Stone Fruits Fruit, stone Stone fruit crop group ( except plums and prunes) Fruit, stone, group, except plum and fresh prune plum Stone fruit, except plum, prune, fresh Fruit, stone, except fresh prune plum 4. In § 180.183, paragraph ( a)( 2)( ii) is revised to read as follows: § 180.183 O, O­ Diethyl S­[ 2­( ethylthio) ethyl] phosphorodithioate; tolerances for residues. ( a) * * * ( 2) * * * ( ii) 5 parts per million in pineapple, bran when present therein as a result of the application of the insecticide in the production of pineapple. * * * * * 5. Section 180.236 is amended by deleting from the table the entries for `` Cattle, goats, hogs, horses and sheep, kidney and liver'' and by alphabetically inserting the following entries: § 180.236 Triphenyltin hydroxide; tolerances for residues. * * * * * Commodity Parts per million Cattle, kidney ............................ 0.05 Cattle, liver ................................ 0.05 Goat, kidney ............................. 0.05 Goat, liver ................................. 0.05 Hog, kidney ............................... 0.05 Hog, liver .................................. 0.05 Horse, kidney ............................ 0.05 Commodity Parts per million Horse, liver ............................... 0.05 * * * * * Sheep, kidney ........................... 0.05 Sheep, liver' .............................. 0.05 * * * * * § § 180.110, 180.163, and 180.379 [ Amended] 6. Sections 180.110( a), 180.163( a), and 180.379( a)( 1) are amended by changing the term `` Winter squash'' to read `` Squash, winter'' and realphabetizing VerDate May< 23> 2002 10: 51 Jun 18, 2002 Jkt 197001 PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 19JNR2. SGM pfrm17 PsN: 19JNR2 41807 Federal Register / Vol. 67, No. 118 / Wednesday, June 19, 2002 / Rules and Regulations the new term and entry where appropriate. 7. In § 180.303, the table to pararaph ( a)( 1) is amended by changing the term `` Winter Squash'' to read `` Squash, winter'' by realphabetizing the new term, and by revising paragraph ( a)( 2) to read as follows: § 180.303 Oxamyl; tolerances for residues. ( a) * * * ( 2) A tolerance of 6 parts per million is established for residues of the insecticide oxamyl ( methyl N, Ndimethyl N­[( methylcarbamoyl) oxy]­ 1­ thiooxamimidate) in pineapple, bran as a result of application of the insecticide to growing pineapple. * * * * * § 180.414 [ Amended] 8. The table § 180.414( a)( 1) are amended by changing and term `` Lima beans'' to read `` Bean, lima'' and by realphabetizing the new term and entry where appropriate. 9. In § 180.409( a)( 1) amend the table by removing the entries `` Cattle, kidney and liver''; `` Goats, kidney and liver''; `` Hogs, kidney and liver''; `` Horses, kidney and liver''; and `` Sheep, kidney and liver'' and by adding alphabetically the following entries to the table: § 180.409 Pirimiphos­ methyl; tolerances for residues. ( a) * * * ( 1) * * * Commodity Parts per million * * * * * Cattle, kidney ............................ 2.0 Cattle, liver ................................ 2.0 * * * * * Goat, kidney ............................. 2.0 Goat, liver ................................. 2.0 * * * * * Hog, kidney ............................... 2.0 Hog, liver .................................. 2.0 * * * * * Horse, kidney ............................ 2.0 Horse, liver ............................... 2.0 * * * * * Sheep, kidney ........................... 2.0 Sheep, liver' .............................. 2.0 * * * * * 10. The table to § 180.410( a) is amended by removing the entry for `` Apple pomace ( wet and dry)'' and by adding alphabetically entries for `` Apple, dry pomace'' and `` Apple, wet pomace'' as follows: § 180.410 Triademifon; tolerances for residues. ( a) * * * Commodity Parts per million * * * * * Apple, dry pomace ................... 4.0 Apple, wet pomace ................... 4.0 * * * * * * * * * * 11. The table to § 180.412( a) is amended by removing the entry for `` Apple pomace, wet and dry'' and by adding alphabetically entries for `` Apple, dry pomace'' and `` Apple, wet pomace'' to read as follows: § 180.412 Sethoxydim; tolerances for residues. ( a)* * * Commodity Parts per million Expiration/ Revocation Date * * * * *. Apple, dry pomace 0.8 None Apple, wet pomace 0.8 None * * * * * * * * * * 12. In § 180.421 the table to paragraph ( a)( 1) is amended by removing the entry for `` Apple pomace ( wet and dry)'' and by adding alphabetically entries for `` Apple, dry pomace'' and `` Apple, wet pomace'' to read as follows: § 180.421 Fenarimol; tolerances for residues. ( a) * * * ( 1) * * * Commodity Parts per million * * * * * Apple, dry pomace ................... 2.0 Apple, wet pomace ................... 2.0 * * * * * * * * * * 13. In § 180.423 amend the table by removing the entries `` Cattle, kidney and liver''; `` Goat, kidney and liver''; `` Hog, kidney and liver''; `` Horse, kidney and liver''; and `` Sheep, kidney and liver'' and by adding alphabetically new entries as follows: § 180.423 Fenridazon; potassium salt; tolerances for residues. * * * * * Commodity Parts per million * * * * * Cattle, kidney ............................ 1.0 Cattle, liver ................................ 1.0 * * * * * Goat, kidney ............................. 1.0 Goat, liver ................................. 1.0 * * * * * Hog, kidney ............................... 1.0 Commodity Parts per million Hog, liver .................................. 1.0 * * * * * Horse, kidney ............................ 1.0 Horse, liver ............................... 1.0 * * * * * Sheep, kidney ........................... 1.0 Sheep, liver' .............................. 1.0 * * * * * 14. Section 180.443( a) is amended by removing from the table the entry for `` Apple pomace ( wet and dry)'', by adding alphabetically an entry for `` Apple, dry pomace'' and by revising the entry for `` Apple, wet pomace'' to read as follows: § 180.443 Myclobutanil; tolerances for residues. ( a) * * * Commodity Parts per million * * * * * Apple, dry pomace ................... 5.0 Apple, wet pomace ................... 5.0 * * * * * * * * * * 15. Section 180.564 is amended by removing from the table in paragraph ( a) the entries for `` Cattle, goat, horse, sheep and hog fat''; `` Cattle, goat, horse, sheep and hog meat''; and `` Cattle, goat, horse, sheep and hog meat byproducts''; and by adding the following entries alphabetically to the table: § 180.564 Indoxacarb; tolerances for residues. ( a) * * * Commodity Parts per million * * * * * Cattle, fat .................................. 0.75 Cattle, meat .............................. 0.03 Cattle, meat byproducts ........... 0.02 * * * * * Goat, fat .................................... 0.75 Goat, meat ................................ 0.03 Goat, meat byproducts ............. 0.02 Hog, fat ..................................... 0.75 Hog, meat ................................. 0.03 Hog, meat byproducts .............. 0.02 Horse, fat .................................. 0.75 Horse, meat .............................. 0.03 Horse, meat byproducts ........... 0.02 * * * * * Sheep, fat ................................. 0.75 Sheep, meat ............................. 0.03 Sheep, meat byproducts .......... 0.02 * * * * * § § 180.455,180.518 and 180.566 [ Amended] 16. Sections 180.455, and 180.518( e) are amended by changing the term for VerDate jun< 06> 2002 19: 38 Jun 18, 2002 Jkt 197001 PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 19JNR2. SGM pfrm15 PsN: 19JNR2 41808 Federal Register / Vol. 67, No. 118 / Wednesday, June 19, 2002 / Rules and Regulations `` Wine grapes'' in the table to both sections to read `` Grape, wine'' and in the table to § 180.566( a) is amended by changing the term `` Wine grapes1'' to read `` Grape, wine1'', and by realphabetizing the new term. [ FR Doc. 02 15332 Filed 6 18 02; 8: 45 am] BILLING CODE 6560 50 S VerDate May< 23> 2002 10: 51 Jun 18, 2002 Jkt 197001 PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 19JNR2. SGM pfrm17 PsN: 19JNR2

epa

2024-06-07T20:31:41.529563

regulations

EPA-HQ-OPP-2002-0043-0002

Rule

Pesticide Tolerance Nomenclature Changes; Technical Amendment (FRL -7180-1)

Friday, June 21, 2002 Part III Environmental Protection Agency 40 CFR Part 180 Pesticide Tolerance Nomenclature Changes; Technical Amendment; Final Rule VerDate jun< 06> 2002 18: 57 Jun 20, 2002 Jkt 197001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\ FR\ FM\ 21JNR3. SGM pfrm15 PsN: 21JNR3 42392 Federal Register / Vol. 67, No. 120 / Friday, June 21, 2002 / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP 2002 0043; FRL 7180 1] Pesticide Tolerance Nomenclature Changes; Technical Amendment AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule; technical amendment. SUMMARY: This document makes minor revisions to the terminology of certain commodity terms listed under 40 CFR part 180, subpart C. EPA is taking this action to establish a uniform listing of the commodity terms. DATES: This document is effective June 21, 2002. FOR FURTHER INFORMATION CONTACT: By mail: Hoyt L. Jamerson, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 308 9368; and e­ mail address: jamerson. hoyt@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: Categories NAICS codes Examples of potentially affected entities Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations,'' `` Regulations and Proposed Rules,'' and then look up the entry for this document under the `` Federal Register Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 180/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. To access an electronic copy of the commodity data base entitled Food and Feed Commodity Vocabulary go to: http:// www. epa. gov/ pesticides/ foodfeed/. 2. In person. The Agency has established an official record for this action under docket control number OPP 2002 0043. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805. II. Background A. What Does this Technical Amendment Do? EPA's Office of Pesticide Programs ( OPP) has developed a commodity vocabulary data base entitled Food and Feed Commodity Vocabulary. The data base was developed to consolidate all the major OPP commodity vocabularies into one standardized vocabulary. As a result, all future pesticide tolerances issued under 40 CFR part 180 will use the `` preferred commodity term'' as listed in the aforementioned data base. This final rule is the second in a series of documents revising the terminology of commodity terms listed under 40 CFR part 180. This revision process will establish a uniform presentation of existing commodity terms under 40 CFR part 180. In this rule, EPA is making the following format changes to the terminology of commodity terms in 40 CFR part 180 to the extent the terminology is not already in this format: 1. The first letter of the commodity term is capitalized. All other letters, including the first letter of proper names, are changed to lower case. 2. Commodity terms are listed in the singular although there are the following exceptions: including the terms `` leaves'', `` roots'', `` tops'', `` greens'', `` hulls'', `` vines'', `` fractions'', `` shoots'', and `` byproducts''. 3. Hyphens are removed from commodity terms. Example ­ `` Cattle, meat by­ products'' is revised to read `` Cattle, meat byproducts''. 4. Commodity terms are amended so that generic terms, such as `` corn'', `` pea'', `` cattle'', precede modifying terms, such as `` field'', `` dry'', `` summer''. Examples ­ `` Corn, field''; `` Pea, dry''; and `` Squash, summer'', not `` field corn'', `` dry pea'', or `` Summer squash''. 5. Abbreviated terms are replaced with the appropriate commodity terms. Examples ­ `` Hog MBYP'' is replaced with `` hog, meat byproducts''. K+ CWHR is replaced with `` kernal plus cob with husks removed''. 6. Parenthesis are replaced with commas. Example ­ `` Cattle meat byproducts ( except kidney)'' is replaced with `` Cattle, meat byproducts, except kidney''. 7. Combined commodity entries are listed separately. Examples ­ `` Goat, kidney and liver'' is revised to read as follows: `` Goat, kidney'', and `` Goat, liver''. `` Fat of cattle, goat, horse and sheep'' is revised to read as follows: `` Cattle, fat'', `` Goat, fat'', `` Horse, fat;'', `` Sheep, fat'' 8. Crop group terms are revised to standardize with the `` Food and Feed Vocabulary''. Examples: i. `` Stonefruit group'' is revised to read `` Fruit, stone, group''. ii. `` Cucurbit Vegetables Crop Group'' is revised to read `` Vegetable, cucurbit, group''. iii. `` Brassica ( cole) leafy vegetables'' is revised to read `` Vegetable, brassica leafy, group''. VerDate jun< 06> 2002 18: 57 Jun 20, 2002 Jkt 197001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 21JNR3. SGM pfrm15 PsN: 21JNR3 42393 Federal Register / Vol. 67, No. 120 / Friday, June 21, 2002 / Rules and Regulations B. Why is this Technical Amendment Issued as a Final Rule? Section 553 of the Administrative Procedure Act ( APA), 5 U. S. C. 553( b)( B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making today's technical amendment final without prior proposal and opportunity for comment, because today's action revises commodity terms listed under 40 CFR part 180, subpart C, in a manner that clearly will have no impact on the meaning of the tolerance regulations. For example, today's action revises commodity terms so that most are in singular ( e. g., `` peach'') instead of the plural ( e. g., `` peaches''). A complete description of the types of changes that are being made has been provided above. EPA has determined that there is no need to public comment on such ministerial changes and thus that there is good cause under 5 U. S. C. 553( b)( B) for dispensing with public comment. While EPA believes that it has correctly identified all instances where these above­ listed revisions need to be made, the Agency would appreciate readers notifying EPA of discrepancies, omissions, or technical problems by submitting them to the address or e­ mail under FOR FURTHER INFORMATION CONTACT. These will be corrected in a future rule. III. Regulatory Assessment Requirements This final rule implements technical amendments to the Code of Federal Regulations which have no substantive impact on the underlying regulations, and it does not otherwise impose or amend any requirements. As such, the Office of Management and Budget ( OMB) has determined that a technical amendment is not a `` significant regulatory action'' subject to review by OMB under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104 4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low­ Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104 113, section 12( d) ( 15 U. S. C. 272 note). Since the action does not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408( n)( 4). For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. IV. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule'' as defined by 5 U. S. C. 804( 2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: June 11, 2002. Marcia E. Mulkey, Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I, part 180, subpart C is amended as follows: PART 180 [ AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U. S. C. 321( q), 346( a) and 374. Part 180, Subpart C [ Amended] 2. In the following table, change the term exactly as it appears in the `` Existing Term'' column to read exactly like the term in the `` New Term'' column wherever they appear in subpart VerDate jun< 06> 2002 18: 57 Jun 20, 2002 Jkt 197001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 21JNR3. SGM pfrm15 PsN: 21JNR3 42394 Federal Register / Vol. 67, No. 120 / Friday, June 21, 2002 / Rules and Regulations C and realphabetize the entry where appropriate: Existing Term New Term Animal feeds Animal feed Artichoke ( globe) Artichoke, globe Barley ( grain) Barley, grain Barley grain Barley, grain Barley ( hay) Barley, hay Bean ( succulent) Bean, succulent Berry ( crop group 13) Berry group Bluegrass hay Bluegrass, hay Cherries Cherry Chestnuts Chestnut Chili peppers Pepper, chili Chinese cabbage Cabbage, chinese Cowpeas Cowpea Crabapples Crabapple Dried Hops Hop, dried cones Elderberries Eldeberry Figs, dried Fig, dried fruit Figs Fig Filberts Filbert Flax seed Flax, seed Galangal root Galangal, roots Goat kidney Goat, kidney Globe artichoke Artichoke, globe Grapefruit oil Grapefruit, oil Grass hay Grass, hay Greens, turnip Turnip, greens Huckleberries Huckleberry Existing Term New Term Kidney of cattle Cattle, kidney Kidney, cattle Cattle, kidney Kidney, goat Goat, kidney Kidney, hog Hog, kidney Kidney, horse Horse, kidney Kidney, sheep Sheep, kidney Kiwi fruit Kiwifruit Kumquats Kumquat Lentils, hay Lentil, hay Lespedeza hay Lespedeza, hay Lettuce ( head) Lettuce, head Lettuce ( leaf) Lettuce, leaf Macadamia nut Nut, macadamia Mamey sapote Sapote, mamey Muskmelons Muskmelon Mustard, greens Mustard greens Mustard green Mustard greens Mustard seed Mustard, seed Oats Oat Oysters Oyster Papayas Papaya Parsley, leaf Parsley, leaves Parsnips ( root) Parsnip, root Parsnips Parsnip Passion fruit Passionfruit Pineapples Pineapple Plums Plum Pome fruit Fruit, pome Quinces Quince Radishes Radish Existing Term New Term Safflower ( meal) Safflower, meal Safflower seed Safflower, seed Safflower seeds Safflower, seed Squash ( summer) Squash, summer Squash ( winter) Squash, winter Sweet corn Corn, sweet Taniers Tanier Taro ( corms) Taro, corm Timothy ( forage) Timothy, forage Timothy ( hay) Timothy, hay Turnip greens Turnip, greens Turnip roots Turnip, roots Turnips ( roots) Turnip, roots Turnips Turnip Vetch hay Vetch, hay Wheat ( forage) Wheat, forage Wheat ( grain) Wheat, grain Wheat ( hay) Wheat, hay Wheat ( straw) Wheat, straw Wheat bran Wheat, bran Wheat flour Wheat, flour Wheat forage Wheat, forage Wheat grain Wheat, grain Wheat hay Wheat, hay Wheat straw Wheat, straw 3. In the following table, change the term exactly as it appears in the `` Existing Term'' column to read exactly like the term in the `` New Term'' column wherever they appear in subpart C and realphabetize the entry where appropriate: Existing Term New Term Apple, dried pomace Apple, dry pomace Artichoke, Jerusalem, postharvest Artichoke, jerusalem, postharvest Beet, garden, root Beet, garden, roots Beet, garden ( roots) Beet, garden, roots Beet, garden ( tops) Beet, garden, tops Beet, sugar ( roots) Beet, sugar, roots VerDate jun< 06> 2002 18: 57 Jun 20, 2002 Jkt 197001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 21JNR3. SGM pfrm15 PsN: 21JNR3 42395 Federal Register / Vol. 67, No. 120 / Friday, June 21, 2002 / Rules and Regulations Existing Term New Term Beet, sugar ( tops) Beet, sugar, tops Beet, sugar, pulp ( dried) Beet, sugar, dried pulp Bean, lima ( succulent form) Bean, lima, succulent Bean, lima ( succulent) Bean, lima, succulent Bermuda grass, forage Bermudagrass, forage Bermuda grass, hay Bermudagrass, hay Birdseed mixtures, postharvest Birdseed, mixtures, postharvest Birdsfoot trefoil, forage Trefoil, birdsfoot, forage Birdsfoot trefoil, hay Trefoil, birdsfoot, hay Brazil nuts, postharvest Nut, brazil, postharvest Caneberries crop subgroup Caneberry subgroup Corn, field, stove Corn, field, stover Corn, forage ( field) Corn, field, forage Corn, forage, field Corn, field, forage Corn, forage, pop Corn, pop, forage Corn, forage, sweet Corn, sweet, forage Chicory, red ( tops) ( also known as radicchio) Radicchio Citrus pulp, dried Citrus, dried pulp Citrus, pulp ( dried) Citrus, dried pulp Citrus fruits ( except mandarins) Fruit, citrus, except mandarin Citrus fruits crop group Fruit, citrus, group Citrus fruits group Fruit, citrus, group Citrus fruits Fruit, citrus Citrus pulp, dried, postharvest Citrus, dired pulp, postharvest Dried citrus pulp Citrus, dried pulp Field corn forage Corn, field, forage Field corn grain Corn, field, grain Field corn stover ( fodder) Corn, field, stover Fruit group, vegetable Vegetable, fruiting, group Fruit, citrus, crop group 10 Fruit, citrus, group Fruit, pome, crop group 11 Fruit, pome, group Fruit, stone, except plum prune, fresh Fruit, stone, except fresh prune plum Fruit, stone, group ( except plums) Fruit, stone, group, except plum Goat meat byproducts Goat, meat byproducts Grape, raisin waste Grape, raisin, waste Grapefruit pulp, dried Grapefruit, dried pulp Grass, canary, annual, seed Canarygrass, annual, seed Grass ( forage) Grass, forage VerDate jun< 06> 2002 18: 57 Jun 20, 2002 Jkt 197001 PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 21JNR3. SGM pfrm15 PsN: 21JNR3 42396 Federal Register / Vol. 67, No. 120 / Friday, June 21, 2002 / Rules and Regulations Existing Term New Term Grass forage Grass, forage Grass, forage, fodder, and hay, group Grass, forage, fodder and hay, group Grain sorghum, postharvest Sorghum, grain, postharvest Leafy greens, subgroup Leafy greens subgroup Leafy Brassica greens crop subgroup Brassica, leafy greens, subgroup Leaf petioles crop subgroup Leafy petioles subgroup Legume vegetable foliage Vegetable, legume, foliage Legume vegetable, cannery waste Vegetable, legume, cannery waste Pea, black­ eyed, postharvest Pea, blackeyed, postharvest Peanut soapstock Peanut, soapstock Peanuts Peanut Plum ( fresh prunes) Plum, prune, fresh Plums ( fresh prunes) Plum, prune, fresh Pome fruits crop group Fruit, pome, group Pome fruits group Fruit, pome, group Prune, dried Plum, prune, dried Prunes, dried Plum, prune, dried Prunes ( dried) Plum, prune, dried Prunes, fresh Plum, prune, fresh Prunes Plum, prune Sorghum, bran Sorghum, grain, bran Sorghum, grain ( milo) Sorghum, grain, grain Sorghum, grain forage Sorghum, grain, forage Sorghum, grain, fodder ( stover) Sorghum, grain, stover Soybean hulls Soybean, hulls Soybean seed Soybean, seed Soybean meal Soybean, meal Soybean soapstock Soybean, soapstock Soybean straw Soybean, straw Soybeans Soybean Sugar beet, dried pulp Beet, sugar, dried pulp Sugar beet, pulp, dried Beet, sugar, dried pulp Sugar beet, molasses Beet, sugar, molasses Sugar beet ( roots) Beet, sugar, roots Sugar beet, roots Beet, sugar, roots Sugar beets, tops Beet, sugar, tops Sugarbeet tops Beet, sugar, tops Sugarbeet, top Beet, sugar, tops VerDate jun< 06> 2002 18: 57 Jun 20, 2002 Jkt 197001 PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 21JNR3. SGM pfrm15 PsN: 21JNR3 42397 Federal Register / Vol. 67, No. 120 / Friday, June 21, 2002 / Rules and Regulations Existing Term New Term Sugarbeet, tops Beet, sugar, tops Sugarbeet, root Beet, sugar, roots Sugarbeet, roots Beet, sugar, roots Sugarbeet molasses Beet, sugar, molasses Sugar beet Beet, sugar Sugar cane, cane Sugarcane, cane Sugar­ cane Sugarcane Sugarcane forage Sugarcane, forage Sunflower meal Sunflower, meal Sunflower oil Sunflower, oil Sunflower seed Sunflower, seed Sunflower seeds Sunflower, seed Sunflower, hulls Sunflower, seed, hulls Sweet corn, forage Corn, sweet, forage Tomato ( products) concentrated Tomato, concentrated products Tomato products, concentrated Tomato, concentrated products Tomato paste Tomato, paste Tomato pomace, dried Tomato, dry pomace Tomato puree Tomato, puree Tree nut group Nut, tree, group Tree nuts group ( except almond hulls) Nut, tree, group Tree nuts group Nut, tree, group § § 180.106, 180.121, 180.182, 180.205, 180.254, 180.298, 180.317, 180.328, 180.377, 180.378, 180.379, and 180.381 [ Amended] 4. The tables to § § 180.106( a), 180.121( a)( 3), 180.182( a)( 1), 180.205( b), 180.254( c), 180.298( a)( 1), 180.317( a), 180.328( a), 180.377( a)( 1), 180.378( b), 180.379( a)( 1), and 180.381( a), are amended by changing the term `` Artichoke'' to read `` Artichoke, globe''. 5. Section 180.275 is amended by removing from the table in paragraph ( a)( 1) the term entry `` Cherry ( sweet and sour)'' and by adding the following entries alphabetically: § 180.275 Chlorothalonil; tolerances for residues. Commodity Parts per million * * * * * Cherry, sweet ....................... 0.5 Commodity Parts per million Cherry, tart ............................ 0.5 * * * * * * * * * * 6. Section 180.412 is amended by removing from the table in paragraph ( a) the entry for the term `` Cherry ( sweet and sour) and by adding alphabetically the following entries: § 180.412 Sethoxydim; tolerances for residues. Commodity Parts per million Expiration/ Revocation Date * * * * * Cherry, sweet ... 0.2 None Cherry, tart ........ 0.2 None * * * * * * * * * * 7. Section 180.443 is amended by deleting from the table in paragraph ( a) the entry for the term '' Cherry ( sweet and sour)`` and by adding the following entries: § 180.443 Myclobutanil; tolerances for residues. Commodity Parts per million * * * * * Cherry, sweet ....................... 5.0 Cherry, tart ............................ 5.0 * * * * * * * * * * [ FR Doc. 02 15464 Filed 6 20 02; 8: 45 a. m.] BILLING CODE 6560 50 S VerDate May< 23> 2002 23: 28 Jun 20, 2002 Jkt 197001 PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 21JNR3. SGM pfrm17 PsN: 21JNR3

epa

2024-06-07T20:31:41.533602

regulations

EPA-HQ-OPP-2002-0049-0012

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES December17, 2002 MEMORANDUM SUBJECT: EFED response to the RRTF's errors­ only comments on the Agency document " Comparative Risks of Nine Rodenticides to Birds and Nontarget Mammals" TO: John Pates, Chemical Review Manager Susan Lewis, Branch Chief FROM: William Erickson, Biologist Douglas Urban, Senior Biologist Environmental Risk Branch III, Environmental Fate and Effects Division THRU: Stephanie Irene, Acting Chief Environmental Risk Branch III, Environmental Fate and Effects Division The Environmental Fate and Effects Division ( EFED) has reviewed the Rodenticide Registrants Task Force's ( RRTF) " errors­ only" response to the Agency document " Comparative Risks of Nine Rodenticides to Birds and Nontarget Mammals" dated October 3, 2001. Their comments of December 10, 2001 were prepared by J. F. Hobson, MorningStar Consulting, on behalf of the RRTF. As stated in the Agency's October 23, 2001 cover letter for the assessment, the registrants' 30­ day response should address only mathematical, computational, typographic, or other similar errors. Matters of policy, interpretation, or applicability of data will be addressed after the public comment period in accordance with the Agency's reregistration process for pesticides. In response to error comments by the RRTF and rodenticide registrants, EFED has made necessary computational and/ or typographical corrections. However, EFED notes that many comments relate to policy, interpretation, or applicability of data, and those comments will be addressed along with public comments after the 60­ day public­ comment period. Page RRTF comment 1 See December 8­ 9, 1998 http:// www. epa. gov/ scipoly/ sap/ 1998/ index. htm 2 i Hazard, not risk. In the Executive Summary, the authors of the Comparative Risks of Nine Rodenticides to Birds and Non­ target Mammals ( PRA) state the risks from brodifacoum and bromadiolone are high for mammalian predators and scavengers that feed on poisoned target species based on laboratory secondary hazard studies and field data. The relationship of these hazard studies to the potential for exposure, and thus risk, to these mammals from commensal uses has not been characterized; therefore, this assessment cannot be called a " risk" assessment and it is inappropriate to say that the " risk" is " high"... Presentation of laboratory secondary toxicity studies. The presentation of secondary toxicity in the laboratory is misleading and reflects a poor understanding of the concepts of hazard versus risk. These are actually a type of dose­ response studies and how many animals die is related to the dose selection and not necessarily to the risk of the compound. Exposure in these lab studies is often not the same as ( or sometimes even close to) exposure under actual field conditions. Furthermore, the protocols and test conditions ( e. g., target and non­ target species, number of animals, period of feeding) used for these studies often differed significantly, therefore it is not appropriate to compare their results as if they were the same as acute LD50 studies or other " standard" guideline studies. EFED response: This has been addressed in the revised document. As the RRTF knows, rodenticide baits are formulated to be lethal to rodents and a few other small mammals, and they are not selective to the target species. Although many factors influence which nontarget animals might be exposed to baits, many nontarget organisms are attracted to and consume grain­ based baits. Predators and scavengers also feed on rats and mice or other target species, and they are not likely to avoid feeding on those that have eaten rodenticide bait. Thus, rodenticide baits also pose potential secondary risks. EFED believes that the potential for risks to birds and nontarget mammals is well established for some of these rodenticides. The risk assessment is based on the available data. Registrants have not submitted the data that would be needed to assess the probability of exposure. These data have been outlined in a section on Uncertainty and Data Needs in the revised assessment. The methodology used is similar to that used in the Agency's " Comparative Analysis of Acute Risk From Granular Pesticides" ( EPA 1992) and " A Comparative Analysis of Ecological Risks from Pesticides and Their Use: Background, Methodology, Case Study" ( EPA 1998) 1; both were reviewed by a FIFRA Scientific Review Panel. Concerning the latter analysis, the Panel noted the many scientific uncertainties in the method, yet agreed that it was a useful screening tool that provides a rough estimate of relative risk. The Page RRTF comment 2 See Guidelines for Ecological Risk Assessment ( EPA/ 630/ R­ 95/ 002F, 1998) at http:// cfpub. epa. gov/ ncea/ cfm/ recordisplay. cfm? deid= 12460 3 Panel made a number of helpful suggestions to improve the utility of the method, most of which are included here. Risk conclusions are presented in tabular and graphical form based on two analyses of the available data. The first is a comparative ranking of the potential risk based on a comparative­ analysis model, and the second is a tabular comparative rating of potential risk based on a qualitative " weight­ of­ evidence" assessment. Quantitative estimates of risk are used in both; however, the " weight­ of evidence" assessment includes qualitative assessments of secondary risk based on mortality and other adverse effects reported in laboratory and field studies, operational control programs, and incident reports, as well as toxicokinetic data and residue levels reported in primary consumers. This approach is in concert with EPA's risk­ assessment guidelines2, where professional judgement or other qualitative evaluation techniques may be used to rank risks using categories such as low, medium, and high when exposure and effects data are limited or are not easily expressed in quantitative terms. i Dietary data are available for mammals for bromadiolone and should be referenced. EFED response: Dietary data are not required for mammals, and none are present for bromadiolone in EFED's toxicity database or the EPA/ OPP Health Effects Division's toxicity database. Statements such as " are available" can't be addressed unless a citation is provided, such as an EPA MRID number for the study. ii Incident data. The discussion of rodenticide wildlife incidents misrepresents the data and does not take into consideration the RRTF review, which noted that approximately one­ third of incidents were redundant within the Environmental Incident Inventory System ( EIIS) and many others are incorrectly attributed to anticoagulants. Summary numbers overstate the number of incidents and in a " weight of the evidence" argument the number of incidents should not be overstated. The authors must adjust the numbers appropriately. EFED response: The RRTF has not identified a single redundant incident in the risk assessment. Stating that there are redundancies in the EIIS is misleading, because the EIIS is a database, and not everything listed in the database is cited in the assessment. The RRTF should address the incident data presented in the assessment, not that in the database. Page RRTF comment 4 ii Kit fox mortalities. This parenthetical reference is misleading, speculative, and inappropriate in the Executive Summary. The 9 Kit foxes were reported as mortalities. Of these, 7 mortalities were attributed to vehicular impact, and 2 were attributed to unknown causes ( not anticoagulants). While low­ level ( trace) residues were found in 8 of 9 Kit foxes, attributing these mortalities to brodifacoum is unfounded and speculative and these statements must be removed from the PRA. EFED response: This statement has been removed from the Executive Summary. However, it is not misleading or speculative to state that brodifacoum residue was detected in the liver of nine kit fox carcasses; that is fact, not speculation. ii, 19, 150 Presence of liver residues. To state that brodifacoum, or other anticoagulants, have been " implicated" or " involved" in rodenticide incidents does not " affirm causality" ( Ecological Risk Assessment ( ERA) Guidelines at 86). Liver residues are a biomarker of exposure. In the initial phase of elimination, liver residues are independent of the magnitude of exposure and a poor correlate with toxicity, although they are persistent. Persistent low­ level residues of brodifacoum, and bromadiolone, have been observed by the State of California in numerous feral coyotes and other animals in perfect health. This fact alone supports an inconsistency in association and a " basis for rejecting causality" ( ERA Guidelines at 86). The statement should say, " residues of brodifacoum, or other anticoagulants, have been detected in wildlife incidents." The role of low­ level residues ( the case for the majority of residues reported in the EIIS) in these incidents is questionable. EFED response: The issue of potential adverse effects to nontarget organisms from sublethal exposure to rodenticides is discussed in the assessment, and EFED notes that the lack of reproduction studies that could help characterize this potential adverse effect adds to the uncertainty of the analysis. These studies will be required through a data call­ in. ii Gastro­ Intestinal Tract ( GIT) should be established as an abbreviation and used consistently throughout the document. EFED response: That correction had already been made in the revised risk assessment. ii, iii Define numbers in parenthesis ( 9) after brodifacoum and ( 3) after bromadiolone. They appear to have no relationship to anything. EFED response: These numbers are not present in the revised risk assessment. iv, 89, Table 47 Risk presumptions in tables. EPA does not describe how the risk Page RRTF comment 5 presumptions ( i. e., low, moderate, high) in the two tables were determined. They appear to have been set using risk summary value data; however, no rating scales or other discrimination criteria have been described. EFED response: That has been addressed in the revised assessment. See also EFED's first comment above. 1 PCO vs. PCA. Reference to a Pest Control Operator ( PCO) is incorrect. Currently, 40 C. F. R. Part 171 refers to a Pest Control Applicator ( PCA) commercial and private. See 40 C. F. R. § 171.2. EFED response: That correction has been made. 1, 2 Presumption of equal exposure. This is a critical error in the PRA. This is inappropriate and there is no justification made for this assumption. Exposure is a key factor in any risk assessment. This presumption makes the entire analysis a " hazard assessment" and not a " risk assessment." It is inappropriate to compare Section 24( c) registrations for field­ use only and Section 18 island restoration uses with products labeled for commensal uses only. Besides inappropriately assuming equal exposure, this assumption also does not account for the large differential in market share among the products registered for commensal uses, a fact clearly stated in Table 1, page 2.... Interchangeability of rodenticides. EPA's justification for a presumption of equal exposure is that it will allow for an evaluation of how risks ( but actually hazard) might increase or decrease as one rodenticide is used instead of another. This means that EPA is assuming that all rodenticides can be used interchangeably and substituted for one another. This may be true for rodenticide active ingredients, but is clearly not the case for rodenticide end­ use products which may have different formulations, bait strengths, target species, use sites, application methods and rates, use restrictions, and so on. This means that EPA's entire hazard analysis applies only to rodenticide active ingredients and has no meaning for evaluating the potential risks of end­ use products because product­ specific and use­ pattern specific factors have not been accounted for through exposure assessments. This limits the usefulness of EPA's analysis from a risk management perspective because it is not possible to propose risk mitigation measures for active ingredients per se and it is inappropriate to propose them for end­ use products without first evaluating product­ specific risks. EFED response: See previous EFED comments on hazard versus risk above. A section titled Use and Exposure Considerations has been added to the assessment. In this section, EFED explains the basis for its exposure calculations and its assumptions. In addition, the Agency does not know the quantity of rodenticides sold and applied in the U. S., although we have repeatedly requested this information from rodenticide registrants. The RRTF, in a conference proceedings ( Kaukeinen et al. 2000), cites over­ Page RRTF comment 3 Ibid. 4 See ECOFRAM Terrestrial Draft Report, 1999 at http:// www. epa. gov/ oppefed1/ ecorisk/ 6 the­ counter container sales for four of the nine rodenticides, but provides no information on geographical or state usage, urban versus non­ urban use, quantity of active ingredient and bait sold, or any information on use by Certified Applicators. Submission of this information will help EFED refine it's risk assessment. 2 For Field Uses, include control of rats and voles under Zinc Phosphide. EFED response: That information was included in Table 2 in the revised risk assessment. 3 Correct reference. Table 2, reference to EPA 1998 a, b should be referenced as EPA 1998 a, b Reregistration Eligibility Decision ( RED). EFED response: That correction has been made. 4 Spelling. Fourth line, " sties" should be " sites." EFED response: That correction has been made. 7 SAP review of the Decision Table Analysis. The Scientific Advisory Panel ( SAP) reviewed this approach and strongly recommended that the term Risk Quotient ( RQ) as used here should be called a " hazard" quotient ( HQ). The RRTF agrees and believes that the terminology should be changed throughout the document consistent with the SAP's comments ( SAP Report No. 99­ 01A, Jan. 22, 1999). EFED response: The recommendations presented to the Agency following a SAP review are just that, recommendations. The Agency must consider the recommendations in light of extant Agency policies and guidance. In this case, EPA's Guidelines for Ecological Risk Assessment3 uses the term Risk Quotient to describe a simple comparison of a measure of exposure divided by a measure of toxicity. In addition, the same guidelines notes that risk quotients provide an efficient, inexpensive means of identifying high­ or low­ risk situations that can allow risk management decisions to be made without the need for further information. Further, subsequent to the aforementioned SAP review, another panel of scientists and risk assessors ­ the Ecological Committee on FIFRA Risk Assessment Methods ( ECOFRAM), stated that RQs do not quantify risk but are useful for comparisons among alternative compounds. 4 Thus, no change in the terminology is needed. Page RRTF comment 7 7 Definition of " effect." The term " measures of effect" as used in the Decision Table Analysis is in error because several of the " effects" discussed are not truly effects, but fate properties of the chemical. For example, it is inappropriate to use the terms " blood retention time" and " liver retention time" as measures of " effect" when the values being used in the assessment are actually elimination half­ life values. The elimination and excretion of second­ generation anticoagulants is biphasic and the initial phase is primarily from the liver. Research has shown that the residues involved in this terminal phase do not appear to contribute to coagulopathy. Further, at non­ toxic concentrations the initial phase of elimination appears to be absent ( Batten and Bratt, 1987). If this is true, then retention time in the liver, at low levels, is not an effect, but a marker of exposure. EFED response: While the retention time is not a direct measure of effect for secondary risk to birds and mammals, it is an important contributing factor. The combination of mean % mortality from secondary laboratory toxicity studies which characterizes the secondary toxicity from short­ term exposures, and available data on retention time in both blood and liver which indicates how long toxic levels can persist in target animal tissues, can characterize the secondary risk to birds and mammals. If, however, retention time in blood and liver were removed from consideration in secondary risk for birds and mammals, the ranking of the rodenticides providing the greatest overall risk to birds and mammals would not change ( As seen in the graphs below, brodifacouum, zinc phosphide and diafethialone provide the greatest overall risk in both cases. Figure 1 shows the comparison with retention time included in secondary risk. Figure 2 show s the comparison with retention times are removed from consideration. When retention times are removed from consideration, the sum of the weighted averages of measures of effect for brodifacoum increases, as does that for difethialone. In addition, the summary values for zinc phosphide and difethialone are almost equal ­ 4.63 and 4.60). Page RRTF comment 8 Brodifacoum 50ppm Bromadiolone 50ppm Bromethalin 100ppm Chlorophacinone 100ppm Chlorophacinone 50ppm Cholecalciferol 750ppm Difethialone 25ppm Diphacinone 100ppm Diphacinone 50ppm Warfarin 250ppm Zinc Phosphide 20,000ppm Rodenticide Baits 0 2 4 6 8 10 Sum of Weighted Averages ( 0 to 10) Primary Risk to Birds Primary Risk to Mammals Secondary Risk to Birds Secondary Risk to Mammals Graph 5. Greatest Overall Risk to Birds & Mammals Sum of Weighted Averages of Measures of Effect Figure 1 Page RRTF comment 9 Brodifacoum 50ppm Bromadiolone 50ppm Bromethalin 100ppm Chlorophacinone 100ppm Chlorophacinone 50ppm Cholecalciferol 750ppm Difethialone 25ppm Diphacinone 100ppm Diphacinone 50ppm Warfarin 250ppm Zinc Phosphide 20,000ppm Rodenticide Baits 0 2 4 6 8 10 Sum of Weighted Averages ( 0 to 10) Primary Risk to Birds Primary Risk to Mammals Secondary Risk to Birds Secondary Risk to Mammals Graph 5. Greatest Overall Risk to Birds & Mammals Sum of Weighted Averages of Measures of Effect Figure 2 Page RRTF comment 10 Page RRTF comment 5 N. B. A correlation coefficient is a number between ­ 1 and 1 which measures the degree to which two variables are linearly related. If there is perfect linear relationship with positive slope between the two variables, the correlation coefficient is equal to 1; if there is positive correlation, whenever one variable has a high ( low) value, so does the other. If there is a perfect linear relationship with negative slope between the two variables, the correlation coefficient is equal to ­ 1; this is a negative correlation, that is, whenever one variable has a high ( low) value, the other has a low ( high) value. A correlation coefficient of 0 means that there is no linear relationship between the variables. 11 7, Table 28 Measures of effect for primary risk to birds. The two measures of effect used in the analysis ( dietary RQ and amount of bait needed to produce an LD50) are not truly independent measures of effect. Both are based on the inherent toxicity of the active ingredient and, though different, are highly correlated. This amounts to " double counting" of the same measure of effect which skews the analysis. EFED response: EFED disagrees that these measures of effect are correlated. The two measures of effect for primary risk to birds were tested for correlation using the ` Correlation and Regression Calculator' at http:// www. ebook. stat. ucla. edu/ cgibin php. cgi/ calculators/ correlation. phtml, and the correlation coefficient was 0.272307, indicating little linear correlation. 5 7, Table 40, Table 41 Use of two retention times as measures of effect. Blood retention time and liver retention time are not independent measures of elimination ( half­ lives). The values for the two retention times are usually not the same for any given species, but are highly correlated because of similarities in metabolism between different organs and tissues. Because the measures are correlated, it is inappropriate for both measures to be used in the analysis as this amounts to " double counting" the same endpoint. This " double counting" tends to exaggerate the magnitude of the summary values, either higher or lower, for all of the rodenticides, and makes those that are more persistent look worse than is actually the case. Furthermore, retention times make poor measures of effect. For example, they cannot distinguish differences in hazard between different bait strengths, as is apparent from the data presented in Tables 40 and 41. EFED response: See previous EFED response on definition of effect on pages 7 & 8. In addition, the values are not " double counted"; each is given a weight one­ half that of other measures ( total weight of blood retention time = 5; total weight of liver retention time = 5; thus, total weight for retention time = 10), so that the two together have a weighting equal to other measures ( i. e., 10). Further, EFED disagrees that retention times are correlated. The retention times for blood and liver were tested for correlation using the ` Correlation and Regression Calculator' at http:// www. ebook. stat. ucla. edu/ cgi­ Page RRTF comment 6 Ibid. 12 bin/ php. cgi/ calculators/ correlation. phtml, and the correlation coefficient was 0.105801, indicating little linear correlation. 6 7, Table 40, Table 41 Double counting of retention times in the analysis. In addition to the double counting issue discussed above, another problem with EPA's methodology is that it uses the same measures of effect for evaluating secondary risks to both birds and non­ target mammals. Because the values for the blood and liver retention times are identical for both the bird and non­ target mammal analyses, this leads to double weighting of these factors when the overall summary values are calculated. This double weighting exaggerates the previously described problem that these two measures of effect are not independent and further compounds their weighting in the analysis, giving them the equivalent of a quadruple weighting. EFED response: See previous EFED response on definition of effect on pages 7 & 8. Again, the values are not " double counted"; each retention time ( blood and liver) is given a weight of 2.5 when used to evaluate each secondary risk ( birds and mammals). Thus, the total weight of blood retention time and the total weight of liver retention time is equal to a weighting equal to other measures ( i. e., 10). 7 Secondary toxicity ( hazard) vs. secondary risk. The mean % mortality from secondary toxicity studies are measures of hazard, not risk, because exposure in these lab studies is often not the same ( or sometimes even close) to exposure under actual field conditions. Further, there is no consideration of the probability of exposure, a key aspect of any risk assessment. EFED response: See previous EFED response on the potential for risk from rodenticides. We also note that to determine the probability of risk would require additional data on toxicity and exposure. Additional data needed to refine this risk assessment is presented in a section on Uncertainty and Data Needs in the comparative risk assessment. 7, Table 40, Table 41 Inappropriate use of data from secondary toxicity studies. The specific end­ use products ( including bait strengths), protocols, and test conditions ( e. g., target and non­ target species, number of animals, period of feeding) used in these studies often differed significantly. Therefore, it is inappropriate to compare the results of mean mortality from one set of studies with those from another set of studies as if they were performed under identical conditions. Page RRTF comment 13 EFED response: A number of laboratory tests using avian and mammalian predators and scavengers to test for mortality due to secondary exposure were available and used in this assessment. Their design and methods varied considerably adding unknown variability to their results and to the analysis. Pending the development of standard methods and testing requirements for these tests they provide the best data available. EFED has identified additional data needed to refine this risk assessment in a section on Uncertainty and Data Needs. 8 Assignment of importance and weights for importance. All measures of effect, except for two, were assigned a " high" measure of importance for the analysis. The two that were assigned a " medium" importance ( half lives in blood and liver) are correlated so " persistence" was also indirectly given a " high" weighting due to double counting. There is no explanation, or rationale, given by EPA for the selection of importance ( high, medium, low) for the different measures of effect or the weights assigned to the importance values ( i. e., high = 10, medium = 5, low = 3.33). EFED response: See previous EFED responses on weighting on page 9, Use of two retention times as measures of effect, and on page 10, Double counting of retention times in the analysis. As noted on page 6 of the document, all measures of effect, except two, are assigned a " high" ( 10 out of 10) measure of importance for the rodenticide analysis. The half­ life in blood and liver are each given a weight of " low" ( 2.5 out of 10) for analyzing secondary risks to birds and mammals, so that the overall importance of the persistence data ( 2.5 x 4= 10) equals but does not exceed that of the mortality data. The intention was to weigh all measures of effects and all risks equally in the analysis. This would eliminate the introduction of any value judgements on the part of the risk assessors. 13 GIT. See GIT comment above for page ii. EFED response: Previously addressed. 13 Categorizing second­ generation rodenticides. Categorizing rodenticide active ingredients as " bad actors" is to use non­ standard, subjective, and qualitative terminology in a regulatory document. It is not a scientific or regulatory term and therefore difficult to interpret in the regulatory context. The Pesticide Action Network ( PAN) is not an official government organization and should not be used as a reference in this document without proper qualification. The World Health Organization ( WHO) may state that the second­ generation active ingredients are " extremely hazardous" ( not representing high risk), but all formulations containing these active ingredients are highly diluted ( 20,000x) in formulation and as formulated products are Category IV ( label word, Caution) for all five acute hazard indicators. This should be a key factor in Page RRTF comment 14 any risk assessment and must be included in the PRA. Thus, the concepts of hazard and risk are again blurred and poorly delineated by the authors of this document. EFED response: That descriptor was removed from the revised risk assessment. The RRTF is correct in stating that rodenticide baits are highly diluted from the pure active ingredient. Nonetheless, registered products have been tested and proven efficacious in killing target species ( rats, mice, and other small mammals); even larger mammals, including humans, have died after ingesting formulated bait. According to the New York State Department of Environmental Conservation, deer died after consuming bait, and HED's toxicity database lists an incident in Indonesia in which 20 people died after consuming brodifacoum­ treated rice intended and labeled for use as a rodenticide. 16 Correct acute toxicity data. Listing for Laboratory Rat, 2.5 and 2.1 should not be, as EPA found this study deficient and therefore unacceptable with a new study being required ( EPA letter dated Feb. 6, 1992). In the replacement study, accepted by EPA, the laboratory oral LD50 for rats was 7.0 mg/ kg. This number should be listed and used in later references. EFED response: The RRTF provides no supporting documentation that this study is " unacceptable". The study is categorized as " supplementary" in the HED's toxicity database, and data from supplementary studies are used in OPP risk assessments. 29 Target species. Table 15 data citation Riedel et al., 1991 is incorrect. Target species is listed as mouse in table; in Literature Citations target is listed as voles. It should be noted, however, that there are no registrations for brodifacoum in the U. S. with voles as a target species. EFED response: The RRTF provides no supporting documentation that this citation is incorrect. The information cited in the risk assessment is correct according to Joermann ( 1998). 30 Correct reference. Table 15 data citation Riedel et al., 1991 is footnoted with reference to Joerman, 1998. This is incorrect. EFED response: The information is cited in Joermann ( 1998). The RRTF does not state why this citation is supposedly incorrect. 30 Correct residue data. Footnote a must be corrected. Data on residue levels in target species have been submitted to EPA ( MRIDs 43534601 and 43534602). The data indicate the results of field trials conducted with diphacinone baits against the California ground squirrel ­­ the principal target species for which diphacinone is used in field applications. Genesis Laboratories, on behalf of the California Department of Food and Page RRTF comment 15 Agriculture ( CDFA), conducted these trials. As part of these trials, dead ground squirrels were collected and analyzed for diphacinone residues. For the 0.005% treatment ( 10 samples), mean whole body residues found were 1.4 ppm with a deviation of 0.8 ppm. For the 0.01% treatment ( 10 samples), mean whole body residues found were 1.4 ppm with a deviation of 0.7 ppm. EFED response: Previously, EFED had no record of these studies but has since obtained copies from the Agency's microfiche files. The residue data from these studies are now included the residue data in the revised risk assessment. 35 Lower number of secondary studies. Last paragraph, sentence 3: In the Bullard, Thompson, and Holguin diphacinone study, accepted and cited by EPA for the liver retention time ( of concern) ­­ 90 days, 30 rats were fed these same livers for 14 days and there were " 0" deaths with no increase in the rats' prothrombin times. That would change the number of secondary studies on diphacinone to 4 studies and change the calculations to 19 ( 30%) of 63 tested mammals dying. To be scientifically consistent, mention of the results of this portion of the study should be made by EPA. EFED response: The Rodenticide Cluster Reregistration Eligibility Decision ( RED) issued in July, 1998, required secondary toxicity studies with a mammalian predator and an avian predator to support reregistration of 0.005% ai and 0.01% ai diphacinone baits. Four years have passed without the registrant addressing this data gap. Because the rat is a target species for rodenticides, citing rat data will not fulfill this secondary­ toxicity requirement. 35 Dietary, not secondary studies. In general, studies with captive or laboratory animals where the chemical is provided to carnivores/ omnivores as spiked meat or dog food preparations are not secondary toxicity studies. These are dietary exposure studies and these references should be removed from this section. EFED response: EFED considers these studies as indicative of secondary toxicity. Nontarget predators and scavengers can be exposed to and adversely affected by rodenticides via dietary exposure to dead or moribund target organisms. Table 37 Diphacinone retention/ elimination. Data in Diaz and Whitacre, 1976 ( which were discussed on the previous page) indicate that elimination of diphacinone in the rat is rapid and similar to chlorophacinone. These data were not included in Table 37 or in EPA's analysis, which relied only on elimination data for blood and liver. Instead, EPA used blood data from cattle and liver data from humans that indicated much higher retention times and produced much higher measure of effect values in Table 40. It is inappropriate to directly compare elimination data generated with cattle and humans with those generated with rats or other species because of interspecies variations in Page RRTF comment 16 metabolism and study dosing regimens. It is also inappropriate to use cattle and human elimination data as measures of effect when neither of these are either target or non­ target species being considered in the assessment. EFED response: Those data are discussed in the risk assessment. The data tabulated are half­ lives and retention times ( days). Those values are not obtainable from Diaz and Whitacre ( 1976); as stated in the risk assessment, nearly a third of the dose administered was not recovered in that study. Tables 40 & 41 Source of data not shown. EPA does not cite the source of the retention time values listed in this table, which are subsequently used to derive measure of effect values. The values cannot be verified without this information. EFED response: Attachment C states the source of data used in the decision analysis. 41 GIT. See GIT comment above for page ii. EFED response: Previously addressed. 45, 46 2 gram pellets, erroneous. Describing the " average pellet" weight as 2 grams is in error by an order of magnitude or more and the large number of LD50s per pellet is incorrect and misleading. For example, Talon 3/ 16 inch pellets weigh, on average, 0.2 g, and a smaller 3/ 32 inch pellet that weighs less is also available. With the exception of mouse­ sized or smaller animals, it is not true that one or two pellets of brodifacoum bait will kill a single animal. Ingestion of 7 to 14 of the larger pellets is required to kill a rat and considerably more for the larger non­ targets. This error is repeated throughout the document and leaves a false impression that one granule will kill an organism. All assumptions, calculations, and conclusions based on this statement must be corrected. EFED response: This correction has been made in the revised risk assessment. 46, Table 26 Source of data not shown. EPA does not cite the source of the LD50 values listed in this table, which are subsequently used to derive measure of effect values. The values cannot be verified without this information. EFED response: Attachment C states the source of data used in the decision analysis. 47 b/ c The dietary RQs should be defined as HQs. The footnotes do not provide sufficient background and justification for the rate ( 100% or 20% intake of daily intake) or timeframe of exposure ( i. e., " several days"). The bottom line is that the concentration in the bait does not provide an estimate of exposure and the PRA does not provide a case Page RRTF comment 17 for the probability of actual exposure. The latter is dependent on use pattern that is ignored in these calculations. EFED response: See previous EFED responses on page 2, for Hazard not risk, and page 5 for Presumption of equal exposure. 47, Table 27 Source of data not shown. EPA does not cite the source of the LC50 values listed in this table, which are subsequently used to derive measure of effect values. The values cannot be verified without this information. EFED response: Attachment C states the source of data used in the decision analysis. 48, Table 28, Figure 1, Attachment C Error in calculation of summary values. EPA has made a significant calculation error when calculating the summary values for primary risks to birds due to a mistake in weighted average values for the second measure of effect ( grams of bait needed for a 50 g bird LD50 dose). EPA calculated the weighted average values for this measure of effect by indexing to the least toxic rodenticide ( diphacinone 50 ppm) rather than the most toxic one as was done for the other measures of effect [ Note: similar incorrect calculations were also done for primary risk to mammals, this will be discussed below]. EPA's method of calculation is presented on page 133 ( Step 3, substep B) in Attachment C. This method skewed results so that both brodifacoum and zinc phosphide were given the same weighted average of 5.0, even though it is clear from the data for this measure of effect that zinc phosphide ( LD50 dose = 0.03 g) is almost 10 times more hazardous than brodifacoum ( LD50 dose = 0.26 g) and should be weighted accordingly. Results for the other rodenticides were also skewed in a similar manner. The table below presents EPA's values and corrected results based on indexing to the most toxic rodenticide by using the inverse of the LD50 dose ( i. e., weighted averages are calculated by indexing to the value of 33.33 g for zinc phosphide, rather than 400 g for diphacinone 50 ppm). After the values have been corrected, zinc phosphide has the highest ranking based on summary values. EFED response: The Agency agrees with using the inverse of the number of bait pellets equal to an LD50 dose and indexing based on the highest number. The necessary corrections have been made in the revised risk assessment. 49 Incorrect presentation of bait concentrations. In all graphs and figures in the document, the assay of active ingredient is listed incorrectly for all products as x mg. This should be correctly listed as x mg/ kg bait or ppm. This must be corrected as it gives the reader a false sense of what is being stated. These are concentrations ( i. e., rates of exposure), not fixed amounts. EFED response: A change to ppm has been made. Page RRTF comment 18 51 Table 29. The footnote for Coumatetralyl and Difenacoum should be ( b) not registered in the United States EFED response: Correction has been made. 54 Nomenclature. The taxonomy entry for Chaffinch should have the scientific name Fringilla coelebs following the entry as this is the first reference to the species. EFED response: Correction has been made. 55 Speculation of sub­ lethal effects. The authors of the PRA refer in several places to speculations by authors that there might be long­ term physiological or behavioral effects. There are no substantive data that support these sub­ lethal effects. All of the references cited by EPA regarding this issue are speculative and no data are available. The only behavioral effects are associated with lethal levels of anticoagulants. Discussion of sublethal effects must be highly qualified as speculative in this document. EFED response: We disagree that all the references cited indicating the potential for sublethal effects are speculative. EFED acknowledges that additional data are needed to confirm the reasoned arguments that sublethal effects adversely impact nontarget organisms exposed to rodenticides. Toward this end, and as previously stated, the potential for adverse sublethal effects will be addressed through a data call­ in. 56 Products not comparable. Paragraph 2. " calciferol" ( vitamin D2) in the UK, is an entirely different product and is unrelated to the cholecalciferol ( vitamin D3) in the U. S. This comparison should be removed as irrelevant. EFED response: The products may be different, but the toxicologically active metabolites may have similar effects, including hypercalcemia and degeneration of bone matrix. Eason et al. ( 2000) state that cholecalciferol ( Vitamin D3) must undergo metabolic conversion to 25­ hydroxycholecalciferol ( 25OHD) to gain biological and toxicological activity. If the RRTF has information that calciferol metabolizes in a different manner or does not have comparable toxicological effects in animals, documentation should be provided. 56 Using correct toxicity data. Second paragraph from the bottom, reference to the decision table analysis should be based on the above­ mentioned 7.0 mg a. i./ kg acute oral dose. EFED response: As previously discussed, EFED has checked the values, and the values used in the risk assessment are correct. Page RRTF comment 19 57 Using correct toxicity data. Table 31. Diphacinone should be listed as 7.0 mg a. i./ kg. ( acute oral rat), instead of the 2.3 found in the EPA unacceptable study. The entries in the table for diphacinone should be: This, of course, changes the summary values for diphacinone. Diphacinone 100 ppm moves to under Chlorophacinone 100 ppm, and Diphacinone 50 ppm moves under Chlorophacinone 50 ppm. EFED response: See previous comment. 57, Table 31 Source of data not shown. EPA does not cite the source of the LD50 values listed in this table, which are subsequently used to derive measure of effect values. The values cannot be verified without this information. EFED response: LD50 values used in the comparative risk assessment are listed in the revised Table 31 in the revised risk assessment. 58­ 59, Table 32, Figure 2, Attachment C Error in calculation of summary values. EPA has made a significant calculation error when calculating the summary values for primary risks to mammals due to a mistake in weighted average values for the measure of effect ( grams of bait needed for a 25 g mammal LD50 dose). EPA calculated the weighted average values for this measure of effect by indexing to the least toxic rodenticide ( chlorophacinone 50 ppm) rather than the most toxic one as was done for the other measures of effect. This method skewed results so that both brodifacoum and zinc phosphide were given almost the same weighted average, even though it is clear from the data for this measure of effect that zinc phosphide ( LD50 dose = 0.03 g) is almost 7 times more hazardous than brodifacoum ( LD50 dose = 0.20 g) and should be weighted accordingly. Results for the other rodenticides were also skewed in a similar manner. The table below presents EPA's values and corrected results based on indexing to the most toxic rodenticide by using the inverse of the LD50 dose ( i. e., weighted averages are calculated by indexing to the value of 33.33 g for zinc phosphide, rather than 3.10 g for chlorophacinone 50 ppm). Note that because there is only one measure of effect for evaluating risk to non­ target mammals, the summary values are identical to the average weighted values for this measure of effect. EFED response: The Agency agrees with using the inverse of the number of bait pellets equal to an LD50 dose and indexing based on the highest number. The necessary corrections have been made. 59 Figure 2. Same changes as Figure 1. EFED response: The necessary changes have been made. Page RRTF comment 20 59 Spelling. Fifth line from the bottom, correct spelling is cholecalciferol. EFED response: Correction has been made. 60 Correction of footnotes. Table 33 ­­ the footnotes for ( c) and ( d) are missing from the table. EFED response: The footnotes have been added within the table. 61 Selective and misleading presentation of data. The entire presentation of the toxicokinetics ( absorption, metabolism, and excretion) is based on a selective and misleading interpretation of the data. The half­ life of residues of second­ generation anticoagulants cannot be characterized by a single number. The elimination from the body is biphasic. The rapid initial ( a­) phase ( a few days) is related to toxicity and the extent of exposure in this phase is the determinant factor in toxicity. The PRA discusses the residues in various tissues and the longer b­ phase of elimination ( hundreds of days) leading the reader to conclude that toxic residues are present for hundreds of days. There are two distinct half­ lives and it is incorrect and misleading to discuss toxic residues as having the longer half­ lives ( hundreds of days). The authors of the PRA, however, ignore discussion from the same articles referenced for residue data ( e. g., Batten and Bratt, 1987) that present observations that the b­ phase is not dose­ related and not related to toxicity ( i. e., coagulopathy). When exposure occurs at non­ toxic levels, only the b­ phase of elimination is evident, indicating that low­ level exposure may occur without being toxicologically significant. This is an important point in a balanced and complete discussion of the toxicokinetics data. EFED response: The existence of biphasic kinetics in the liver is now discussed in a comprehensive and balanced way in the document. However, the RRTF should be aware that not all studies have demonstrated biphasic elimination. 64 Correction. The first sentence on this page is incorrect. Two animals did not die in the top dose level. All animals that exhibited marked toxicity were euthanized according to the protocol. The authors of the PRA ignore one of the major points of this paper, that toxicity is associated with the rapid a­ phase of clearance and not the b­ phase of clearance. The b­ phase residues are associated with long­ term liver residues and are independent of dose. This makes liver residues, especially low­ level residues, a good marker of exposure, but a poor indicator of causative agent. EFED response: See previous comment. As previously noted, the issue of low­ level exposure will be addressed through a data call­ in. Page RRTF comment 21 70 GIT. See GIT comment above for page ii. EFED response: Previously addressed. 70 Secondary hazard vs. risk. The authors discuss laboratory data as a basis for determining secondary risk. This is not possible. Risk cannot be determined without an estimate or probability of exposure. As discussed by the SAP ( SAP Report No. 99­ 01A, Jan. 22, 1999) in reviewing the Decision Analysis, this is a hazard assessment, not a risk assessment. The SAP Report states: " The Panel encourages the Agency to change the term risk to " hazard." The calculation of the RQ does not include elements of risk. . . ." EFED response: See previous EFED responses above. 71, Table 40 Correction, Table 40. For diphacinone, secondary mortality, EPA has used an active ingredient blended rate of mortality of 9.0%. This should be a product­ specific value, however. As in the previous Table 13, " Secondary Toxicity of Diphacinone to Birds . . .," it is clearly shown that there is a difference in secondary toxicity to the predator if the prey receives bait containing 50 ppm versus products or prepared diets with higher concentrations. When predators consume prey that fed upon bait containing 50 ppm or less, there is " 0%" mean mortality to the secondary species. This demonstrates the problem of confusing active ingredient vs. formulated product and should be corrected before the PRA is released for public comment. EFED response: Nine percent mean mortality was assigned to both formulations of diphacinone as a measure of secondary risk based on the assumption that the target would contain approximately the same residue regardless of which formulation it was exposed to. Data providing more detailed information by formulation is needed to refine this assessment. 72 Field data taken out of context. In this document, numerous types of field studies are referenced, but none of these studies are directly applicable to assessing the risks of products used to control commensal rodents ( i. e., " in and around buildings"). It is unclear to the reader that these field data are from research and development studies for products never registered or for localized island restoration projects. This false impression must be corrected prior to public release of this document. EFED response: The Agency believes that the description of the field studies and their results provide accurate information on the effects of rodenticides outdoors and and does not leave the reader with a false impression. There is no clear distinction between commensal uses and field or other outdoor uses. Labels for commensal­ use products do not limit bait placements to any specified distance from buildings, and " in and around buildings" may be interpreted differently among rodenticide users. Thus, some Page RRTF comment 22 commensal uses, especially in rural areas, might have comparable exposure scenarios to some field uses. 73 Relevance of field studies conducted outside the United States. Studies such as Duckett, 1984, involving Asian owls in Malaysian oil­ palm plantations, are not relevant to the labeled use in the United States. Asian owls are larger and take larger prey ( e. g., rats) than do North American owls. Rats were present due to the monoculture of this crop and owls were encouraged to inhabit the plantations using nest boxes. At the same time, anticoagulants are used to control rats. This is completely opposite of the use pattern labeled in the United States. Although some hazard information can be gleaned from such studies, there is no relevance to the exposure to wildlife from current use patterns ( i. e., commensal uses). This must be clearly stated. EFED response: These studies are presented in a hazard context and confirm the potential for adverse effects of exposure. See also previous comment. 75 The author's use of unrelated data to justify a position that is incorrect and misleading. The " Incident Data Birds and Non­ target Mammals," page 77 through 86 of the PRA is used as a reference. The author references the RRTF's proposal for a 0.7 ppm threshold of toxicity for brodifacoum in liver tissue ­­ a concept clearly based on brodifacoum data. The author cites a study, Savarie et al., 1979, in which liver tissue from coyotes was examined and found to contain residues of < 0.7 ppm diphacinone. The use of unrelated data ( brodifacoum vs. diphacinone) to justify a position ( rejection of the toxicity threshold of 0.7 ppm based on brodifacoum data, the largest body of data for any of the rodenticides) is not scientifically justified. EFED response: The reference to the diphacinone study was deleted from this discussion in the revised risk assessment. The RRTF is correct in stating that such a " threshold of toxicity" would need to be established for each of the nine rodenticides if the concept were to be of any value. Addressing the issue of adverse effects from sublethal toxicity also needs to be considered in such a threshold. 75 Inappropriate comparisons. Table 41. Decision Table Analysis for Secondary Risk to Bird. It is not scientifically justified to compare rodenticides, when values for Blood Retention and Liver Retention are taken from different species, e. g., cattle and humans vs. rats. EFED response: EFED acknowledges the variable nature of the retention data; however, these are the only data available. Additional data on retention in tissues of target organisms would greatly facilitate a refinement of the risk assessment. 76 Figure 4. The same correction as in previous figures. Page RRTF comment 23 EFED response: The necessary changes have been made. 77 Errors in the EIIS database carry over to the PRA. The EPA, in conducting the PRA of anticoagulant rodenticides, emphasizes the number of wildlife mortality incidents reported to EPA, particularly by California and New York. EPA data on wildlife mortality incidents were obtained through a request for information by the RRTF under the Freedom of Information Act ( FOIA). These data have been reviewed and analyzed by cross­ referencing to EPA and state ( California, New York, and other states) incident numbers, the report date, the species reportedly involved, the compound( s) reported, the number of individual mortalities reported per incident, tissue residue levels, the presence of raw data, the presence of necropsy information, the relative condition of carcasses, and any indication of intentional or unintentional misuse ( off­ label use) of the rodenticide products. The underlying data was also analyzed using a threshold of toxicity based on liver residues ( Kaukeinen, Spragins, and Hobson, 2000) that differentiates residues that are clearly acutely toxic and very low residues that are simply a marker of exposure. This analysis demonstrates that the toxicological and ecological significance of the wildlife mortality incident data for anticoagulant rodenticides is greatly overstated. There are numerous factors that restrict the number of wildlife mortality incidents that can be accurately attributed to anticoagulant rodenticides. There are as many as 30% redundant reports ( i. e., multiple reports of the same incident) in the EIIS database relative to anticoagulants. EPA conclusions relative to many incident reports are not supported by the underlying data. For many of the incident reports the residue levels of anticoagulants are very low and are not indicative of anticoagulant toxicity. Reported pathological observations are often not diagnostic of anticoagulant toxicity and often do not provide a basis for attributing mortality to anticoagulant rodenticides. The role of misuse ( intentional or unintentional) is not consistently documented in incident reports, but may play a role in the many incidents attributable to anticoagulant rodenticides. The primary conclusion of this analysis is that the magnitude of reported incidents alleged to be caused by anticoagulant rodenticides is significantly over­ estimated. When incident numbers for the 226 incidents referred to in the PRA were requested by the RRTF, the authors did not have the incident numbers, suggesting that the analysis by the RRTF was not reviewed or considered by EPA prior to finalizing the current draft of the PRA. If the RRTF analysis of the EIIS database had been thoroughly reviewed, the incident numbers would have been obtained for comparison. The RRTF believes that the errors pointed out in the EIIS database constitute a serious error in the PRA and must be corrected before this document is released for public review. EFED response: The RRTF's assertion that the authors did not provide incident tracking numbers is incorrect. Incident tracking numbers for all incidents cited in the assessment Page RRTF comment 24 were provided ( via the Special Review and Reregistration Division) to the RRTF when requested in November of 2001. The Agency is now aware of 258 rodenticide incidents. 81 Correct spelling is Contra Costa County. EFED response: The change from " Contra costa County" to " Contra Costa County" has been made. 81 Unbalanced review of data. The authors of the PRA spend more than half of a page justifying the reference to one Golden eagle mortality arguing that it is a brodifacoum mortality with 0.04 ppm in the liver. Brodifacoum was only " implicated," however. This raises three important issues: 1) the majority of residues reported in wildlife are below 0.7 ppm in the liver and one­ third are below 0.1 ppm, making interpretation of low­ level residues a very important issue requiring a comprehensive, scientifically defensible discussion; 2) residues below 0.7 ppm are frequently reported in healthy feral animals; and 3) pathology is not diagnostic of anticoagulant toxicosis and cannot be used in combination with low­ level liver residues as the determinative criteria of a causative agent in a wildlife mortality incident. The majority of reported liver residues of anticoagulant rodenticides in the EIIS database are well below 0.7 ppm; therefore, it is important to understand the significance of such residues. If there is no consistency in association, causality cannot be confirmed and must be rejected. California and New York incident data were analyzed by the RRTF utilizing a threshold of 0.7 ppm brodifacoum ( and possibly other anticoagulants) in liver. Applying this threshold to the data from both states ( which is primarily for brodifacoum) indicates that approximately two­ thirds of all incidents with residue data are below 0.7 ppm in the liver. One­ third of incidents had reported liver residues below 0.1 ppm. The predominance of low­ level residues in mortality reports emphasizes the importance of accurate interpretation of their significance. This merits a balanced discussion. There are numerous reports in the literature and by state agencies that document measurable liver residues of brodifacoum and other anticoagulants in perfectly healthy feral animals. In the analysis of ten coyotes, the conclusion of an unpublished California Department of Fish and Game ( CDFG) report was: " the residue concentrations in these otherwise healthy animals may suggest that background levels of anticoagulant rodenticides are found in urban carnivores " ( Table 81a) ( p­ 2051, Hosea, 1999). In other incident reports by CDFG, however, lower level residues of second­ generation anticoagulants are cited as diagnostic of the anticoagulant as the causative agent of observed mortality ( Hosea, 1999). These inconsistencies demonstrate the difficulty of ascribing causality in these cases, and the value of agreed protocols for pathology and chemical analysis ( Brown et al., 1996). Detection of low­ level residues may represent Page RRTF comment 25 the slow terminal phase of clearance with residues sequestered in the liver, and must be carefully interpreted with respect to any forensic, diagnostic, or toxicological significance. Long­ term anticoagulant feeding studies in rats, such as with diphacinone, for example, failed to find consistent effects on clotting times or general health and feeding behavior at levels of 0.03 to 0.5 ppm over 90 days of continuous feeding ( Elias and Johns, 1981). All of the animals were free of any apparent trauma or disease, and necropsy revealed no evidence of hemorrhage ( other than one hematoma caused by the administration of the lethal injection). All 5 of these animals carried residues of brodifacoum in the liver and 4 of the 5 carried multiple anticoagulant residues ( Table 81b). It is apparent that liver levels of brodifacoum characterized in many wildlife reports as diagnostic of toxicity and fatality are also found as background levels in the livers of healthy wildlife. Finally, low­ level residues of anticoagulants are often used, regardless of the magnitude of the residue, to confirm pathological observations. In combination, these low­ level residues and pathology cannot be used to determine that an anticoagulant rodenticide is the causative agent. Pathology is often the primary criteria in wildlife incident reports used to conclude anticoagulant toxicity. Although the lesions observed in incident reports may be indicative with anticoagulant toxicity, they are general and not diagnostic. Pathology, necropsy, and clinical signs of toxicity following anticoagulant exposure reported in published literature were compared by the RRTF to the information in the EIIS wildlife incident reports ( Berny et al., 1997; DuVall et al., 1989; Elias and Johns et al., 1981; Gray et al., 1994; Hegdal and Colvin, 1988; Huckel et al., 1988; Meehan, 1984; Newton et al., 1990; Rammell et al., 1984). The descriptions of anticoagulant toxicity in controlled studies were for the most part general. These descriptions include external hemorrhage and internal hemorrhage in a number of organs, including brain, kidney, lungs, heart, and gut. Major organs, including the liver, may exhibit diffuse pallor. First signs often include bloody diarrhea or urine. A number of articles cautioned that care must be taken in diagnosing anticoagulant poisoning both because obvious symptoms may be lacking and not every hemorrhagic lesion denotes anticoagulant poisoning. Other causes of coagulopathy noted in these articles include: infectious canine hepatitis, hemorrhagic disease of pigs, cows, and chicks, heat stroke, aflatoxicosis, vitamin K deficient diet, trauma, inherited clotting factor deficiencies, and consumption of naturally occurring anticoagulants ( e. g., dicumarol in sweet vernal hay). In summary, pathologic observations should be used as secondary indicators of anticoagulant toxicity and not in combination with low­ level anticoagulant residues. Although they may be indicative, they are not diagnostic. There are other causes of these generic types of lesions. Page RRTF comment 26 EFED response: As previously stated, the issue of low­ levels of residue will be addressed through a data call­ in. 82 Correction. The reference Savarie et al., 1979 included oral doses of 0.63, 1.25, 2.5, 5, and 19 mg a. i./ kg. Table 44 lists the doses as 0.63, 1.25, 2.5, 5, and 10 mg a. i./ kg EFED response: The doses listed in the table are correct. The doses are not cited in the text in the revised risk assessment. 83 Footnote for Dicoumarol is missing. This product is not registered in the United States as a rodenticide EFED response: Footnotes are used only in the tables, not in the text. Dicoumarol is an anticoagulant compound. 87, Table 46 Errors in EPA's calculations ( Table 46). EPA has made a significant calculation error when deriving the summary values for primary risks to both birds and non­ target mammals. EPA incorrectly calculated the weighted average values for the following measures of effects: 1) grams of bait needed for a bird LD50; and 2) grams of bait needed for a non­ target mammal LD50. Values were indexed to the least toxic rodenticides rather than the most toxic ones. This error changes the overall rankings of the nine rodenticides, as well as the magnitude and spread of the summary values among the nine products. The correct summary values are presented in Table 5 ( Note: this is a revised Table 46 from the PRA). Based on the new overall summary values, brodifacoum is still ranked first ( i. e., " most hazardous"). Zinc phosphide, formerly fifth, is now ranked second, although its summary value is almost the same as brodifacoum. The two diphacinone baits are now ranked fourth and fifth overall as opposed to formerly being ranked as third and sixth, and their overall summary values are lower. The two chlorophacinone baits are now ranked eighth and ninth overall versus previous rankings of ninth and eleventh, but again the relative numbers and differences are lower than before, indicating less overall hazard than previously expressed. EFED response: The necessary changes have been made. 88 Figure 5. The same correction as previous figures. EFED response: The necessary changes have been made. 89 Figure 6. The same correction as previous figures. EFED response: The necessary changes have been made. Page RRTF comment 7 Ibid. 27 90, Figure 7 Flaw in sensitivity analysis. Because several of the measures of effect were significantly correlated, the sensitivity analysis would not be expected to show differences in rankings when values for the measures of effect were varied. EFED response: EFED disagrees that several the measures of effect are in fact correlated. Specifically, the two measures of effect for primary risk to birds and the retention times for blood and liver were tested for correlation using the ` Correlation and Regression Calculator' at http:// www. ebook. stat. ucla. edu/ cgibin php. cgi/ calculators/ correlation. phtml, and the correlation coefficients were 0.105801 and 0.272307, respectively, indicating little linear correlation. 7 91 Distinctions between 50 and 100 ppm baits. EPA states that distinctions cannot be made between 50 ppm and 100 ppm chlorophacinone and diphacinone baits using the incident data, " but the 100 ppm baits are likely to present greater risk than 50 ppm baits." This may seem like an obvious statement, but in fact it may not be true because of differences in the formulations and use patterns between the baits containing 100 ppm and 50 ppm of these active ingredients. It is not correct to assume that they are used interchangeably. Some pelleted baits containing 50 ppm active ingredient are used " in and around" homes for commensal control while other 50 ppm grain­ based baits are used in bait stations for control of ground squirrels and other field rodents. The 100 ppm baits are grain­ based and only used in agricultural settings for control of ground squirrels and field rodents. The 100 ppm baits are applied by broadcast methods ( mechanical or hand) and are not used in bait stations. Secondary risks to birds and non­ target mammals are dependent, in part, on residues in the target species and could potentially be higher for 50 ppm baits because of greater bait availability in bait stations and many other factors. EFED response: EFED believes that this discussion actually argues that the 100 ppm baits are likely to present greater risk to non­ target organisms than the 50 ppm baits. In addition, it seems counter­ intuitive to argue that bait stations would present greater availability to non­ target organisms than broadcast applications without some supporting data. 91 Use of 6­ g pellets for ground squirrel control. Ground squirrels are selective feeders much of the year and bait acceptance can greatly limit the time available for applications. Regardless of size, use of pellets instead of grains for spot and broadcast baiting will likely reduce bait acceptability and efficacy from the current formulations. More importantly, concentrating the amounts of active ingredients through use of large pellets may increase the potential primary and secondary risks to non­ target mammals, thus offsetting the potential benefit of reduced risks to birds. Risk to non­ target mammals Page RRTF comment 28 could be increased for several reasons. Use of larger baits will make it easier for non­ target mammals, such as coyotes and Kit foxes, to obtain a lethal dose through direct ingestion of pellets. EFED response: This discussion has been deleted from the document. 93 Use pattern and market share. The Decision Table Analysis ranks the relative hazard of the different active ingredients, but does not estimate exposure, without which risk cannot be estimated. The assumption of equal exposure is totally inappropriate considering the divergent use patterns of products included in this analysis and the high market share held by certain active ingredients. Use pattern is a key factor in any pesticide risk assessment and the exposure is use pattern and often chemical­ specific. Brodifacoum ( 50 ppm), bromadiolone ( 50 ppm), difethialone ( 25 ppm), diphacinone ( 50 ppm), chlorophacinone ( 50 ppm), bromethalin ( 100 ppm), cholecalciferol ( 750 ppm), warfarin ( 250 ppm), and zinc phosphide ( 20,000 ppm) baits[ 1] are all registered for " commensal uses" in the U. S. Commensal use is defined as " in and around buildings, transport vehicles and other manmade structures." Commensal rodents exist because man has provided highly desirable conditions for them to do so ( i. e., structures which provide food, water, and/ or harborage). In the absence of control measures, commensal rodent populations will escalate because the highly favorable environment provided by man is not balanced by the rodents' natural predators. Farmers, consumers, and professional exterminators for the protection of health and property from commensal rodents use commensal use rodenticides. Commensal rodents typically include the house mouse, the Norway rat, and the roof rat. In some instances, other rodent species, e. g., the deer mouse, can become commensal ( i. e., invade structures). Certain rodenticides are also approved for field uses. Field use constitutes use against rodents living " in the field," i. e., not associated with man­ made structures. Most typically these rodenticides are used for crop protection, but can also be used against public health pests ( e. g., California ground squirrel control for plague prevention). Zinc phosphide bait ( typically 20,000 ppm) is the most widely used, being federally registered for a range of uses against a comparatively broad range of rodent and related pests. Some Section 24( c) registrations exist for diphacinone and chlorophacinone and also for some non­ federally registered uses of zinc phosphide. Warfarin was recently approved for use against moles below ground. A below ground use diphacinone pocket gopher bait was federally registered, but it is unclear whether this registration is still active. There was also a 24( c) for cholecalciferol that is inactive. A few highly specialized uses also exist for certain products for the purpose of natural ecosystem restoration. Brodifacoum has been used on uninhabited islands in the U. S. and elsewhere to remove non­ native rats ( arriving originally by ship) that predate and significantly endanger local fauna, typically birds. Diphacinone is used in Hawaii for controlling mongoose and rats that predate native birds. These uses are highly regulated, being carried out by government personnel only, and constitute an extremely small proportion of overall rodenticide use. There are Page RRTF comment 29 no other field uses approved in the U. S. for brodifacoum, and no field uses at all for bromadiolone, difethialone, or bromethalin. EFED response: As previously noted, the risk assessment is based on the available data. Registrants have not submitted the data that would be needed to assess the probability of exposure. These data have been outlined in a section on Uncertainty and Data Needs. in the revised assessment. 96 Incorrect term. The term PCO's is used and this term is not defined and is incorrect. See discussion above. EFED response: Previously addressed. 127 & 128 Missing data. Where no data were available, the specific measure of effect was not included in the analysis for that particular active ingredient. This causes an over weighting of data for those measures of effect where data were available. EFED response: Missing data does add uncertainty to the results of the assessment. This is acknowledged and the data needed to refine this assessment are presented in a section on Uncertainty and Data Needs. In addition, many of the studies required in the Rodenticide Cluster Reregistration Eligibility Decision ( RED) have not yet been submitted, even though the RED was issued in July, 1998. 134 Correct calculation error. Attachment 1, Results of the Comparative Analysis, Step 3, Substep B, the entry for Bromethalin 100 mg should read (( 400.0­ 2.30)/ 400)* 5= 4.97, the LD50 for Bromethalin from Table 1 is 2.30 EFED response: The necessary changes have been made. 135 Correct calculation error. Attachment 1, Results of the Comparative Analysis, Step 4, the entry for Bromethalin 100 mg should read 0.04+ 4.97= 5.01, the sum from Step 3, Substep A, and Substep B. EFED response: The necessary correction has been made. 135 Correct calculation error. Attachment 1, Results of the Comparative Analysis, Step 4, the entry for Diphacinone 100 mg should read 0.10+ 2.50= 2.60, a simple math computation error, this may or may not have effects on the overall hazard assessment. EFED response: The sum of the weighted average values for Diphacinone 100 mg should be 0.01+ 2.50= 2.51. No change was made. Page RRTF comment 30 147 HD5 data. The method used to extrapolate the HD5 ( 50%) from one bait concentration to another is not appropriate as it does not take into consideration the slope of the dose­ response relationship for the active ingredient. For example, reducing the concentration of active ingredient by 50% will not necessarily reduce toxicity by 50% depending on the slope of the dose­ response relationship. EFED response: The extrapolation from one bait concentration to another does depend upon the slope. However, since slope information was not available, the assumption is that the slope is consistent with a 50% reduction in toxicity when the concentration of the active ingredient is reduced 50%. 151 Correct reference to Table 42. Total incidents of 271 does not match Table 42 summary. EFED response: The number of incidents has been updated in the revised risk assessment. 153­ 155 Graphs 9, 10, 11 Lack of correlation. These plots do not show a strong relationship between summary risk values and the number of incidents, suggesting that the two are not highly correlated and that EPA's measures of effect may not be good predictors of incidents. This should not be surprising since EPA's analysis did not account for exposure and product­ specific use pattern differences, whereas the incident data better reflect actual exposure, including factors such as market share. Note that the relationships in the graphs will become even weaker once the " corrected" summary values in Table 46 are plotted against the number of incidents. Note also that if data for brodifacoum are removed from the graphs, the data become an almost random scatter gram with no predictive power. EFED response: This graph was not meant to show an overall correlation between summary risk values and the number of incidents. Rather, the graphs show that the rodenticide baits with the greatest number of reported incidents and the largest summary risk values should appear in the upper left of the graph. In all three graphs brodifacoum is the only bait to appear in this position. Thus, the graph confirms that brodifacoum poses the greatest overall potential risk to birds. The corrected summary values do not significantly weaken this confirmation.

epa

2024-06-07T20:31:41.539566

regulations

EPA-HQ-OPP-2002-0049-0013

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES December 17, 2002 MEMORANDUM SUBJECT: EFED response to Bell Laboratories' errors­ only comments on the Agency document " Comparative Risks of Nine Rodenticides to Birds and Nontarget Mammals" TO: John Pates, Chemical Review Manager Susan Lewis, Branch Chief FROM: William Erickson, Biologist Douglas Urban, Senior Biologist Environmental Risk Branch III, Environmental Fate and Effects Division THRU: Stephanie Irene, Acting Chief Environmental Risk Branch III, Environmental Fate and Effects Division The Environmental Fate and Effects Division ( EFED) has reviewed Bell Laboratories' 30­ day errors­ only response to the Agency document " Comparative Risks of Nine Rodenticides to Birds and Nontarget Mammals" dated October 3, 2001. Bell Laboratories' comments of December 6, 2001 were prepared by C. W. Spragins. As stated in the Agency's October 23, 2001 cover letter for the assessment, the registrants' 30­ day response should address only mathematical, computational, typographic, or other similar errors. Matters of policy, interpretation, or applicability of data will be addressed after the public comment period in accordance with the Agency's reregistration process for pesticides. In response to error comments by Bell Laboratories, other rodenticide registrants, and the Rodenticide Registrants Task Force, EFED has made necessary computational and/ or typographical corrections. However, EFED notes that many comments relate to policy, interpretation, or applicability of data, and those comments will be addressed along with public comments after the 60­ day public­ comment period. 1 See December 8­ 9, 1998 http:// www. epa. gov/ scipoly/ sap/ 1998/ index. htm 2 Dear Mr. Pates: Please accept the following comments as part of Bell Laboratories' response to EPA's document entitled " Comparative Risks of Nine Rodenticides to Birds and Nontarget Mammals" ( CRA). Note that further commentary from Bell will be provided through the joint comments that will be submitted shortly by the Rodenticide Registrants Task Force. 1. Comment: The CRA includes a large amount of information on the toxicity and possible hazards associated with consumption by mammals or birds of rodenticides or rodents that have consumed rodenticides. The CRA is however, not a true risk assessment as risk takes into consideration hazard combined with exposure probability. Exposure models and probabilities are not considered in the CRA, hence it cannot be considered a risk assessment. The presumption of equal exposure in the document is in no way justified. As the Agency may be aware some other governments are looking at the ecological risks of various pesticides, including rodenticides. In discussion of this topic with the UK authorities who are conducting a review at present, they pointed out that they would not jump to any conclusions or take actions until they " felt they had developed a reasonable model for assessing exposure", which they don't feel exists for rodenticides at present. A risk assessment cannot be completed without such a model. EFED response: It is well known that rodenticide baits are formulated to be lethal to rodents and a few other small mammals, and they are not selective to the target species. Although many factors influence which nontarget animals might be exposed to baits, many nontarget organisms are attracted to and consume grain­ based baits. Predators and scavengers also feed on rats and mice or other target species, and they are not likely to avoid feeding on those that have eaten rodenticide bait. Thus, rodenticide baits also pose potential secondary risks. EFED believes that the potential for risks to birds and nontarget mammals is well established for some of these rodenticides. The risk assessment is based on the available data. Registrants have not submitted the data that would be needed to assess the probability of exposure. These data have been outlined in a section on Uncertainty and Data Needs in the revised assessment. The methodology used is similar to that used in the Agency's " Comparative Analysis of Acute Risk From Granular Pesticides" ( EPA 1992) and " A Comparative Analysis of Ecological Risks from Pesticides and Their Use: Background, Methodology, Case Study" ( EPA 1998) 1; both were reviewed by a FIFRA Scientific Review Panel. Concerning the latter analysis, the Panel noted the many scientific uncertainties in the method, yet agreed that it was a useful screening tool that provides a rough estimate of relative risk. The Panel made a number of helpful suggestions to improve the utility of the method, most of which are included here. 2 See Guidelines for Ecological Risk Assessment ( EPA/ 630/ R­ 95/ 002F, 1998) at http:// cfpub. epa. gov/ ncea/ cfm/ recordisplay. cfm? deid= 12460 3 Risk conclusions are presented in tabular and graphical form based on two analyses of the available data. The first is a comparative ranking of the potential risk based on a comparative­ analysis model, and the second is a tabular comparative rating of potential risk based on a qualitative " weight­ of­ evidence" assessment. Quantitative estimates of risk are used in both; however, the " weight­ of evidence" assessment includes qualitative assessments of secondary risk based on mortality and other adverse effects reported in laboratory and field studies, operational control programs, and incident reports, as well as toxicokinetic data and residue levels reported in primary consumers. This approach is in concert with EPA's risk­ assessment guidelines2, where professional judgement or other qualitative evaluation techniques may be used to rank risks using categories such as low, medium, and high when exposure and effects data are limited or are not easily expressed in quantitative terms. 2. Comment: The tone of the CRA is disappointingly biased for what should be a scientifically objective review by a government agency. It appears the outcome was decided in advance and the authors constructed the document to prove the outcome. In blunt terms, the CRA reads like a Brodifacoum witch hunt. The CRA includes presentation of many lab dosing studies wherein the investigators record relatively black and white results which is quite appropriate provided they are presented for what they are ( such data encompasses potential hazard, but only plays a part in assessing overall risk). Where the picture gets particularly muddled is in the presentation of incident data and in field studies wherein the investigators for example go out seeking animals to analyze after a product has been used in an actual treatment program for which it is registered. Such data has considerably more value in assessing actual risk but are also much more open to intepretation, speculation and bias. It is in the presentation of this type of data that the CRA falls woefully short of objectivity and the line between fact and speculation is repeatedly blurred. The authors give much space and weight to results from those investigators who concur with the outcome that appears to have been decided in advance. Some of these investigators are openly biased, for example Ward Stone has stated publicly that he " will see the end of Brodifacoum". Charles Eason developed Cholecalciferol for the lucrative New Zealand possum control market and has an interest in it's success. Brodifacoum ( and Compound 1080) are direct and less expensive competitors. The Cholecalciferol product was registered for possums in New Zealand in about 1996, and since that time, Mr. Eason has generated an ongoing stream of studies and papers directed at the hazards of Brodifacoum use. While the authors of the CRA subject the considerable amount of information and analysis submitted by the RRTF to only brief review and harsh criticism, there appears to be little critical analysis of the cited data that concurs with the apparently predetermined outcome. While the Agency might argue that registrants also 4 have an " agenda", registrants' data has always been subjected to far more critical review by the Agency than that of those who oppose pesticides or certain pesticides, and are thus forced to be far more scientifically certain of their results presented. EFED response: This is not an errors response. EFED believes that the risk assessment presents an accurate balance of results from available reports and the contention that it is biased is unsupported. EFED notes that the peer reviews and the credentials of the peer reviewers will be available in the public docket. 3. Much of the data presented in the second category as noted above ( incident and actual field data) are from outside the United States where the use patterns are completely different. For example, Eason's New Zealand work refers to broadcast uses over large land areas. Field ( noncommensal uses do not exist in the U. S. for Brodifacoum, or other second generation compounds ( except in the tiny exception of specific island restoration, which is irrelevant in the context of the CRA as such uses undergo extensive evaluation for ecologial impact on a specific case by case basis before they are approved. It is interesting that the authors, while mentioning the island use, fail to state that the purpose of such use is to actually preserve the native fauna and flora ­ i. e. a benefit of rodenticides. Brodifacoum is most often chosen for such uses due to its very high level of effectiveness). The CRA contains other examples of data from uses which do not exist in the U. S. as well, and fails overall to transparently make the distinction. Again, such data are useful in assessing hazard, but must be viewed very carefully in assessing actual risk. EFED response: This is not an errors response. EFED notes that the field studies are presented in a hazard context and confirm the potential for adverse effects in exposed nontarget animals, regardless of the use pattern or location. The Agency believes that the description of the field studies and their results provide useful information on the effects of rodenticides used outdoors. 4. The CRA makes repeated reference to an " 2­ gram bait pellet" or a 2­ gram grain, eg. an oat groat and uses this to state that a " single pellet or grain" can deliver a lethal dose ­ an incorrect statement. These numbers are grossly inaccurate ­ all of Bell's commensal use pellets are 0.2 g or less and the vast majority of field use pellets as well ( a very large pellet, approaching 2 g, was used for the Anacapa island restoration project). Oats groats are about 0.1 g each. Conversely, the Agency chooses a 25 g non­ target mammal for its calculations, which is at the extreme bottom end of the spectrum of mammals ( only mice are that small as adults and they are typically the target species). EFED response: The size of the bait pellet has been corrected in the revised assessment.

epa

2024-06-07T20:31:41.552085

regulations

EPA-HQ-OPP-2002-0049-0014

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES October 15, 2002 MEMORANDUM SUBJECT: EFED response to Syngenta's errors­ only comments on the Agency document " Comparative Risks of Nine Rodenticides to Birds and Nontarget Mammals" TO: John Pates, Chemical Review Manager Susan Lewis, Branch Chief FROM: William Erickson, Biologist Douglas Urban, Senior Biologist Environmental Risk Branch III, Environmental Fate and Effects Division THRU: Stephanie Irene, Acting Chief Environmental Risk Branch III, Environmental Fate and Effects Division The Environmental Fate and Effects Division ( EFED) has reviewed Syngenta's 30­ day errorsonly response to the Agency document " Comparative Risks of Nine Rodenticides to Birds and Nontarget Mammals" dated October 3, 2001. Syngenta's comments of December 5, 2001 were prepared by J. Hott, Regulatory Product Manager, with support from J. Akins, Toxicologist; D. Kaukeinen, Technical Specialist; and J. Shaw, Environmental, Stewardship and Policy Leader. As stated in the Agency's October 23, 2001 cover letter sent for the assessment, the registrants' 30­ day response should address only mathematical, computational, typographic, or other similar errors. Matters of policy, interpretation, or applicability of data will be addressed after the public comment period in accordance with the Agency's reregistration process for pesticides. In response to error comments by Syngenta, other rodenticide registrants, and the Rodenticide Registrants Task Force, EFED has made necessary computational and/ or typographical corrections. However, EFED notes that many comments relate to policy, interpretation, or applicability of data, and those comments will be addressed along with public comments after the 60­ day public­ comment period. 2 " Comparative Risks of Nine Rodenticides to Birds and Nontarget Mammals": Syngenta Response GENERAL COMMENTS Document is not a " Risk Assessment". The EPA document " Comparative Risks of Nine Rodenticides to Birds and Nontarget Mammals" reviews hazard studies and incidents and develops hazard indices, but does not adequately address the important exposure portion to establish " Risk". There is a clear difference between the term and meaning of " Risk" as compared to " Hazard". Risk is a function of the Hazard ( toxicity characteristics) and exposure ( product use and associated exposure potential). Given that the remit of EFED biologists was to produce a Rodenticide Risk Assessment, we maintain that this goal has not yet been achieved because no exposure analysis has been provided. In fact, the resulting " Hazard Study" is preliminary to a Problem Formulation stage, which would normally precede a Risk Assessment. EFED response: This has been addressed in the revised document. As Syngenta knows, rodenticide baits are formulated to be lethal to rodents and a few other small mammals, and they are not selective to the target species. Although many factors influence which nontarget animals might be exposed to baits, many nontarget organisms are attracted to and consume grain­ based baits. Predators and scavengers also feed on rats and mice or other target species, and they are not likely to avoid feeding on those that have eaten rodenticide bait. Thus, rodenticide baits also pose potential secondary risks. EFED believes that the potential for risks to birds and nontarget mammals is well established for some of these rodenticides. The risk assessment is based on the available data. Registrants, including Syngenta, have not submitted the data that would be needed to assess the probability of exposure. These data have been outlined in a section on Uncertainty and Data Needs in the revised assessment. The methodology used is similar to that used in the Agency's " Comparative Analysis of Acute Risk From Granular Pesticides" ( EPA 1992) and " A Comparative Analysis of Ecological Risks from Pesticides and Their Use: Background, Methodology, Case Study" ( EPA 1998); both were reviewed by a FIFRA Scientific Review Panel. Concerning the latter analysis, the Panel noted the many scientific uncertainties in the method, yet agreed that it was a useful screening tool that provides a rough estimate of relative risk. The Panel made a number of helpful suggestions to improve the utility of the method, most of which are included here. Risk conclusions are presented in tabular and graphical form based on two analyses of the available data. The first is a comparative ranking of the potential risk based on a comparative­ analysis model, and the second is a tabular comparative rating of potential risk based on a qualitative " weight­ of­ evidence" assessment. Quantitative estimates of 3 risk are used in both; however, the " weight­ of evidence" assessment includes qualitative assessments of secondary risk based on mortality and other adverse effects reported in laboratory and field studies, operational control programs, and incident reports, as well as toxicokinetic data and residue levels reported in primary consumers. This approach is in concert with EPA's risk­ assessment guidelines ( EPA 1998), where professional judgement or other qualitative evaluation techniques may be used to rank risks using categories such as low, medium, and high when exposure and effects data Document does not provide for " Risk/ Benefit" Considerations. The benefit analysis and regulatory history sections are completely absent in the EPA Comparative Assessment document as compared with the EPA RED in 1998 ( page 102­ 103, 7­ 8). This is an error based on the FIFRA law, which is a Risk­ Benefit law. These are especially important sections, since the target species and non­ target species ( mammals) are nearly identical physiologically. It is impossible to identify a rodenticide that poses no risk to mammals, and the EPA " recognizes that new technologies do not exist" for rodent control ( EPA RED Rodenticide Cluster). In other Reregistration Eligibility Decision and Reduced Risk assessments with which we are familiar, the Agency systematically addresses the products' use in accordance with benefits, including Resistance Management. The second­ generation rodenticides were designed to control populations of rodents that are resistant to the first generation rodenticides and to eliminate the need for refeeding to ingest lethal doses. The ecological risk posed by second­ generation rodenticides should be analyzed separately from the first generation. First generation rodenticides should not be used to replace the second­ generation rodenticides unless one is willing to further increase the range of resistant rodent populations and return to the greater exposure represented by refeeding requirements. The benefits of rodenticides in general in combating harmful pest rodents need to be considered. Acceptable risk levels for rodenticides cannot be set without establishing some measure of the economic and public health detriments that pest rodent cause. EFED response: The Agency will be considering benefits of rodenticides in a later phase of the reregistration process. The current document is EFED's assessment of risks. Exposure considered comparable for all rodenticides. The Review's assumption that exposure of non­ target organisms is equivalent for the various rodenticides ( pages 1­ 2 and elsewhere) ignores very significant differences in activity and action, market share, label uses, and formulation differences. Risks will not increase or decrease equally if one rodenticide is used instead of another. In fact, some rodenticides have singular utility. Brodifacoum, for example, is the only anticoagulant documented and labeled to control both warfarin­ resistant rats and warfarin­ resistant 4 mice. Brodifacoum can be used outside of structures in non­ urban areas, whereas bromadiolone and difethialone cannot. Bromadiolone and brodifacoum can be used outside in burrows, but difethialone cannot. So there cannot be an equal substitution of one second­ generation anticoagulant for another. The brodifacoum label is broader than the other products in recognition of its superior efficacy and the additional data that was provided by Syngenta and its heritage companies. EFED response: EFED's previous comment addresses exposure. EFED also notes that the Agency requested use information from registrants prior to issuance of the Rodenticide Cluster Reregistration Eligibility Document ( RED), but that information was not provided. Differences is uses among the rodenticides will be considered and reevaluated during the reregistration process. Toxicological and hazard findings taken out of context. Rodenticides are by their nature, vertebrate pesticides. No " perfect rodenticide" has yet been developed that is specific to rodents. It is hardly surprising that non­ target animals can be poisoned under controlled conditions in the laboratory or through misuse in the field. However, such findings are often irrelevant or insignificant in regard to the commercialized, intended use pattern. Yet this review presents an exhaustive summary of such disparate information as a basis for Agency concern. Likewise, a review of incident data is not a substitute for an exposure assessment. Incidents are a function of the prevalence of use and how the product is used or misused. Incident data would more properly be useful in the development of a Problem Formulation stage of a risk assessment, prior to an exposure analysis. Highly different studies and incident situations are grouped together in this document for comparison. No consideration is given to the quality of studies, the purposes for which they were conducted, and their appropriateness for a risk evaluation. The abbreviated nature and wide data spread of many studies make their utility limited. In many cases in conclusions and calculations, specific non­ target animal feeding behaviors and diet preferences are ignored in making assumptions of amounts of rodenticides consumed directly ( primary exposure) or indirectly ( secondary exposure). Many incidents appear to have no confirmed cause of death, or have multiple causative factors. The use patterns and practices that have been developed and formalized into labeling statements and the products allowed by the Agency to be marketed have resulted from extensive studies that registrants have conducted to meet Agency requirements. The efficacy studies required for the advanced anticoagulants ( single­ feed) in particular have selected for highly active products. It now seems the Agency is concerned about the very product qualities that directly resulted from the very test requirements that registrants were required to meet from the EPA. Evaluations with compounds such as brodifacoum have been extensive. 5 Advanced non­ target risk evaluations involving radio telemetry studies were conducted at the request of the Agency under an EUP program, in full consultation with Agency biologists. The resulting barn owl field study evaluated commensal rodent baiting hazards for brodifacoum to the raptor most at risk, and the Agency accepted both the protocol for this work as well the independent study directors' findings ( Hegdal and Blaskiewicz, 1984). These findings were that commensal baiting did not pose a significant risk to populations of barn owls. Too little has been made of this study in the Agency " Comparative Risk" document which, at its core, is about raptor hazard with an emphasis on brodifacoum. In fact, the barn owl study met the Tier 3 requirements that addressed these non­ target concerns back in the early 1980s. It is entirely proper to question older data, but no information is presented to refute the earlier findings, and they should not be ignored. The barn owl findings resulted in the Agency allowing brodifacoum products to be used outside of structures in non­ urban areas, unlike the other advanced anticoagulants. Furthermore, the EPA stated in the 1998 RED that: " The U. S. Environmental Protection Agency ( EPA) has completed its reregistration eligibility decision of the pesticides brodifacoum, bromadiolone, chlorophacinone, diphacinone and its sodium salt, bromethalin, and pival and its sodium salt. This decision includes a comprehensive reassessment of the required target data and the use patterns of currently registered products. These chemicals are rodenticides used in urban, suburban, and rural areas for the control of commensal rodents. . With the exception of pival and its sodium salt, the Agency has concluded that the uses, as prescribed in this document, with additional labeling requirements and a number of risk mitigation measures, will not cause unreasonable risks to humans or the environment The Agency has determined that all uses of brodifacoum, bromethalin, and bromadiolone are eligible for reregistration." EFED response: This is not an errors response. These issues will be addressed along with other responses after the public­ comment period. Pooling of Wildlife Incident Data. In other Reregistration Eligibility Decision and Reduced Risk assessments that have been addressed by the Agency over the last ten years or more, the Agency systematically addresses the product's use and resulting exposure and risk potential to nontarget wildlife. The current document mentions the use site areas, but it does not separate the uses regarding risk. Three critical issues, pertaining to incident data, that need to be addressed are listed below: 1) The EPA over­ interprets the impacts of residue analysis to the causation of mortality. Low levels of persistent compounds such as brodifacoum cannot be directly related to cause of death, particularly when case study information indicate other lethal or potentially lethal effects such as vehicle impact. The Agency should break out 6 incident data where causation cannot be determined or where multiple potential causative factors were identified. 2) When comparing the incident or study data between active ingredients, the EPA should take into account how and where the product was used, and the total amount of product that is being used. In order to allow for comparisons to be made, the Agency should, at a minimum, divide incidents into the following groups: a) Incident occurred by intentional poisoning; b) Incident resulting from the experimental application of a rodenticide ( e. g., for control of orchard voles) in efficacy or hazard studies involving a use pattern that is different from the commensal rodent use pattern. c) Incident occurred by off­ label use in the United States ( e. g., misapplications or uses in other countries that are different that US); d) Incident occurred by currently labeled use. 3) Establish the total sales of the product compared to the total number of incidents. i) It is important to take into account the total sales of a product and use of a product before comparing risk. In the case of brodifacoum, the Agency indicates that the product has 180 incidents, which the Agency alleges is far more than the other rodenticides. However, earlier in the document, the Agency states that brodifacoum makes up for more than 93% of the total sales of rodenticides in the United Sates. When the ratio of incidents to containers sold for brodifacoum in 1997 is compared with four other rodenticides incidents to sales ratio in 1997, brodifacoum is determined to pose the least risk ( Table 1). Based on this analysis, if bromodiolone were to replace brodifacoum, one would expect a 31­ fold increase in wildlife incidents with bromodiolone. ii) This analysis should be conducted once the above steps are completed to take into account the product use and confidence in the causation. 7 Table 1. Incident Risk Based on Total Product Sold. Rodenticide Total incident # * Total incident # in 1997 Total Container Sales in 1997 # Incidents / Total Containers Sales in 1997 # Incidents in 1997/ Total Container Sales in 1997*** Brodifacoum 180 ** 44,144,456 0.0000041 << 0.0000041 Bromadiolone 37 ** 294,706 0.00013 < 0.00013 Diphacinone 18 ** 2,860,419 0.0000063 << 0.0000063 Chlorophacinone 10 ** 18,360 0.00054 < 0.00054 * The number of incidents is captured from many years. ** This number needs to be calculated. *** This number needs to be calculated taking into account the total number of containers sold over the same period of time that the incidents were recorded. EFED response: EFED believes it is highly misleading to refer to " total" incidents, rather than " reported" incidents, because most incidents are not reported. The Agency does not know the amount of brodifacoum or other rodenticides sold and applied in the U. S., although we have repeatedly requested this information from rodenticide registrants. The statement that brodifacoum accounts for 93% of the over­ the­ counter sales ( not total sales) was attributed to an RRTF article ( Kaukeinen et al. 2000) in a conference proceedings. However, the only information provided is container sales for four of the nine rodenticides. No information is provided regarding container sizes, regional or state use, or other important use information. In a meeting with the Agency on October 9, 2002, the RRTF provided a handout on " Estimates of % Chance of Incidents Occurring Based on Total Number of OTC Placements". The chance of an incident occurring was based solely on an estimate of total placements compared to the total number of incidents reported. However, such estimates are of little value without factoring in the probability that an incident occurs but is not discovered, the probability that an incident is discovered but not reported to the proper authorities, and the probability that an incident is reported but no residue analysis is conducted. Moreover, simply considering over­ the­ counter sales completely ignores incidents that might occur from use by Certified Applicators. Statistical Methodology The EFED has not utilized standard and conventional methodologies that allow for a true risk assessment on rodenticidal baits and thus, this document falls short of the standard EFED Tier 1 Agency assessments that we are familiar with for other products. No scientific rationale is provided to support the methodology and approach used by EFED. The HD5 method, for example, is utilized in the document for rodenticides; will all 8 pesticides now be analyzed by the HD5 method? Is this method recommended by the EFED Probabilistic Risk Assessment team as more appropriate than other methods? Summary values produced by the analyses do not provide a comparison of risk, but rather reflect the particular ` measures of effect' selected by EFED and the weighing that EFED gave them. Parameters such as body retention times are only one component and do not necessarily relate to risk determination. A decision­ making analysis does not appear to be appropriate for an ecological risk assessment, nor is it an adequate substitute for the scientific evaluation of exposure and risk. Such a decision­ making analysis might more properly be used following completion of a risk assessment, such as in a ` reduced risk rationale'. Based upon our exposure to the science of risk assessment, we believe there are better and more appropriate approaches to develop probabilistic methods with better application to rodenticides than those chosen by EFED in this review. EFED response: This is not an errors response, but EFED notes that EFED's Probabilistic Risk Assessment team and Division Director were consulted. They, as well as numerous internal and external reviewers, concurred that the approach used in the assessment is appropriate for the available data. See also previous comments. Specific Errors and Comments: The references to 2­ gram pellets ( pages 45, 46, 57 and 91) are incorrect. Talon pellets of 3/ 16 inch weigh, on average, 0.2 grams each, not 2 grams. Therefore, an animal eating 2 grams of Talon would need to be ingesting 10 pellets, not one. Only for mice or mouse­ sized animals does an LD50 allow for one brodifacoum pellet to approximate a lethal dose. Likewise, calculations such as in Table 31 equating LD50 to dose in numbers of pellets are off by an order of magnitude because of this error. EFED response: The size of the bait pellet has been corrected in the revised assessment. The " Bird LD50" ( page i and elsewhere) of 0.26 mg/ kg is actually the mallard LD50. Other birds including raptors have LD50s of 10 to 40 times this amount ( Godfrey, 1985). It is misleading to choose the lowest LD50 figure to represent all bird species. The mallard study utilized a vitamin K­ deficient diet, causing an abnormally low value; a normal diet produced a mallard LD50 of 2.0 mg/ kg. EFED response: EFED reports an LD50 of 0.26 mg/ kg for the mallard in Table 3 of the risk assessment. That value is based on a " core" study submitted to the Agency. Syngenta has provided no documentation that the mallard acute­ oral study was based on a vitamin K­ deficient diet. In fact, a previous acute oral study was invalidated because vitamin K ( an antidote) had been added to the test diet. The value of 2.0 mg/ kg cited by Syngenta is actually an LC50 from a dietary study, and it is reported as an LC50 value in Table 3 and is used in the RQ calculations for dietary risk. Syngenta should also note 9 that Table 3 lists LD50 values of < 0.75 mg/ kg for both the Canada goose and the southern black­ backed gull, neither of which is " 10 to 40 times" greater than the value of the mallard. It is inappropriate to group end­ point results of different toxicology studies from the standpoint of risk assessment ( pages i, ii, 19, 151 and elsewhere). Many of these studies were designed to reach an endpoint. The greater number of studies on brodifacoum are a result of its popularity as a rodenticide. Fewer studies were done on other anticoagulants so fewer poisoned birds were produced. These studies cannot thus be compared. The statement that brodifacoum exhibits much more secondary toxicity risk to birds than other anticoagulants, while not adequately determined, is followed by a statement that difethialone secondary risks are likely comparable to those posed by brodifacoum ( page i). EFED response: This is not an errors response. Policy and procedural matters will be addressed along with other responses after the public­ comment period. Comments on sublethal effects of anticoagulants are speculative and contrary to all research findings from over 20 years of intensive study of these compounds by researchers ( pages 74, 96 and elsewhere). The only effect of these products is on the clotting ability of the blood. Similar products are utilized as human medications to prevent blood clots and behavioral side­ effects are not noted. EFED response: Syngenta has provided no supporting documentation for this assertion. The issue of sublethal effects will be addressed through a data call­ in. Likewise, the argument for individual susceptibility is speculative ( page 45). Scientific procedures establish median values ( such LD or LC values) on which to base regulatory and developmental decisions. Regulatory law cannot be developed based upon an undemonstrated fear of outlying values. Why is persistence equated with toxicity ( pages 60, 61, 66 and elsewhere)? The livers of birds and mammals are designed to sequester and breakdown foreign substances so that they can be excreted from the body. Only circulating levels of anticoagulants in blood that are high enough to affect coagulation are of concern. Low levels of anticoagulant in the liver are biomarkers of some prior exposure but cannot be demonstrated to be causative in deleterious behavioral or health effects. EFED response: While the retention time is not a direct measure of effect for secondary risk to birds and mammals, it is an important contributing factor. The combination of mean % mortality from secondary laboratory toxicity studies which characterizes the secondary toxicity from short­ term exposures, and available data on retention time in both blood and liver which indicates how long toxic levels can persist in target animal tissues, can characterize the secondary risk to birds and mammals. The relationship 10 between liver residues and toxicity is discussed in the document. Methods to determine what liver concentration might corroborate death from anticoagulant exposure, or even if such a cause­ effect relationship is appropriate, e. g., the " threshold of toxicity" concentration in liver tissue are requested in the section on Uncertainty and Data Needs in the comparative risk assessment. Because of the commensal rodent use pattern, it is generally recognized that dogs are the non­ target animals most at risk, and certainly more dog incident and treatment data is available than, for example, with birds. Syngenta believes the Agency could have made more use of companion animal hazard and risk information in ranking rodenticides or for application to determinations for other animals. However, dog toxicity information ( pages 56­ 60) is poorly presented in the Agency review document. An adequate review of the published literature has not been carried out by the Agency and a table of accurate dog LD50 values for rodenticides is not presented, only a commentary citing a mixture of tolerated dose studies of limited utility. Difethialone has a published LD50 value of 4.0 mg/ kg ( Liphatech Tech Bulletin). Bromadiolone has an LD50 to dogs of 8.1 as reported in Poche ( 1988). This data supercedes that in Marsh, 1985 as quoted by the Agency. We note that only the lower LD50 values in Marsh, 1985 were chosen for the Agency's example, rather than the middle or upper values within the range of published LD50s that Marsh cites. The definitive brodifacoum dog study was published by Godfrey, M. E. R., Reid, T. C., and McAllum, H. J. F. ( 1981). The Acute Toxicity of the Anticoagulant Brodifacoum to Dogs". N. Z. Journal of Experimental Agriculture. 9, 147­ 149. This article notes a 3.56 mg/ kg value based on a test involving 59 adult mixed­ breed dogs. The dose that resulted in no adult mortalities was 0.5 mg/ kg ( 59 dogs). Brodifacoum, while highly toxic to rodents, may not possess a significantly greater toxicity to mammals such as dogs than other advanced anticoagulants. The following table derived from the 1990 National Animal Poison Control Center Annual Report supports the contention that non­ target poisonings seen with brodifacoum result in no greater percentage of symptoms or death than other commonly­ available anticoagulant and non­ anticoagulant rodenticides. 11 Table 2. Call Incidence from National Animal Poison Control Center, 1990* Rodenticide % Dog % Cat % Symptoms** % Deaths** Brodifacoum 81.3 5.9 15.1 6.0 Bromadiolone 78.1 5.3 26.8 9.8 Diphacinone 80.3 2.6 36.8 7.0 Warfarin 79.1 6.7 12.7 13.2 Bromethalin 74.9 9.1 22.9 2.5 Cholecalciferol 81.5 6.5 40.8 12.4 * Percent incidence calculated from total number of calls for each compound ** Totals for combined dog and cat calls EFED response: EFED believes that the toxicity data presented for the nine rodenticides is comprehensive. Data having more recent dates do not ` supercede' older data; they are simply additional data to consider. As Syngenta knows, EFED assesses risks to nontarget wildlife, not pets. The Agency considers dogs to be domestic pets, and risks to domestic pets are addressed by the Agency's Health Effects Division. Moreover, the Godfrey et al. ( 1981) study was an antidote study, not an acute­ oral toxicity study.

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regulations

EPA-HQ-OPP-2002-0049-0016

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES December17, 2002 MEMORANDUM SUBJECT: EFED response to HACCO's errors­ only comments on the Agency document " Comparative Risks of Nine Rodenticides to Birds and Nontarget Mammals" TO: John Pates, Chemical Review Manager Susan Lewis, Branch Chief FROM: William Erickson, Biologist Douglas Urban, Senior Biologist Environmental Risk Branch III, Environmental Fate and Effects Division THRU: Stephanie Irene, Acting Chief Environmental Risk Branch III, Environmental Fate and Effects Division The Environmental Fate and Effects Division ( EFED) has reviewed HACCO's " errors­ only" response to the Agency document " Comparative Risks of Nine Rodenticides to Birds and Nontarget Mammals" dated October 3, 2001. HACCO's comments of December 6, 2001 were prepared by J. A. Thompson, Registration Manager, Rodenticides. As stated in the Agency's October 23, 2001 cover letter for the assessment, the registrants' 30­ day response should address only mathematical, computational, typographic, or other similar errors. Matters of policy, interpretation, or applicability of data will be addressed after the public comment period in accordance with the Agency's reregistration process for pesticides. In response to error comments by HACCO, other rodenticide registrants, and the Rodenticide Registrants Task Force, EFED has made necessary computational and/ or typographical corrections. However, EFED notes that many comments relate to policy, interpretation, or applicability of data, and those comments will be addressed along with public comments after the 60­ day public­ comment period. 2 Re: Preliminary Comparative Ecological Risk Assessment for Rodenticides Dear Mr. Pates: I am writing to address several very serious concerns that HACCO, Inc has with EPA* s " Preliminary Comparative Ecological Risk Assessment for Nine Rodenticides" ( PRA) dated October 3, 2001. The compounds included in the assessment are: brodifacoum, difethethialone, bromadiolone, diphacinone, chlorophacinone, warfarin, zinc phosphide, bromethalin and cholecalciferol. HACCO, Inc. holds active registrations for the following rodenticide active ingredients included in this Assessment: Diphacinone, Brodifacoum, Warfarin and Zinc Phosphide. We, HACCO, Inc,. are members of the Rodenticide Registrants Task Force ( RRTF) and of the Zinc Phosphide Consortium along with many other rodenticide registrants. We have been active in presenting the Agency with added information in regards to rodenticide benefits, usage, toxicity, and relative safety. However, the present version of the PRA contains significant errors and does not incorporate many of the RRTF* s comments submitted in response to EPA* s October 19, 1999, meeting regarding risks to birds and non­ target mammals. HACCO strongly urges that the Agency does not release this PRA to the public. This PRA needs to be revised substantially before it can be released to the public. HAZARD COMPARISON VERSUS RISK ASSESSMENT In reading this document, the overall concern is that this PRA is a hazard comparison and not a risk assessment. EPA does not address and characterize exposure. EPA does not address the facts that these active ingredients are used differently and that formulations of these compounds may vary the characterization of exposure. Certain formulations and bait forms may reduce exposure under certain use patterns. The Agency assumes that all exposures are equal in its equations to evaluate risk. In examining field uses, however, the Agency in the PRA gives an example of how a bait form could vary a " risk" through limiting " exposure" when it addresses the desirability of broadcasting a 6 gram pellet to protect birds from primary exposure. As another example of how formulation and form will affect exposure, a broadcast use of grain bait might be preferred where the concern is primary exposure of non target canines. The Agency gave the first example listed above, but the Agency does not characterize exposure components in its equations to evaluate risk. The Agency needs to address exposure to do a " risk" assessment. The Agency needs to broaden the way it looks at rodenticides to include use patterns in the United States, sales volume, formulations and bait forms, identification and behavior of non targets within the vicinity of an application, so that an examination of the actual exposure of non targets can be made. Risk should not be estimated without an adequate characterization of exposure. EFED response: This has been addressed in the revised document. It is well known that rodenticide baits are formulated to be lethal to rodents and a few other small mammals, and they are not selective to the target species. Although many factors influence which nontarget animals might be exposed to baits, many nontarget organisms are attracted to 1 See December 8­ 9, 1998 http:// www. epa. gov/ scipoly/ sap/ 1998/ index. htm 2 See Guidelines for Ecological Risk Assessment ( EPA/ 630/ R­ 95/ 002F, 1998) at http:// cfpub. epa. gov/ ncea/ cfm/ recordisplay. cfm? deid= 12460 3 and consume grain­ based baits. Predators and scavengers also feed on rats and mice or other target species, and they are not likely to avoid feeding on those that have eaten rodenticide bait. Thus, rodenticide baits also pose potential secondary risks. EFED believes that the potential for risks to birds and nontarget mammals is well established for some of these rodenticides. The risk assessment is based on the available data. Registrants have not submitted the data that would be needed to assess the probability of exposure. These data have been outlined in a section on Uncertainty and Data Needs in the revised assessment. The methodology used is similar to that used in the Agency's " Comparative Analysis of Acute Risk From Granular Pesticides" ( EPA 1992) and " A Comparative Analysis of Ecological Risks from Pesticides and Their Use: Background, Methodology, Case Study" ( EPA 1998) 1; both were reviewed by a FIFRA Scientific Review Panel. Concerning the latter analysis, the Panel noted the many scientific uncertainties in the method, yet agreed that it was a useful screening tool that provides a rough estimate of relative risk. The Panel made a number of helpful suggestions to improve the utility of the method, most of which are included here. Risk conclusions are presented in tabular and graphical form based on two analyses of the available data. The first is a comparative ranking of the potential risk based on a comparative­ analysis model, and the second is a tabular comparative rating of potential risk based on a qualitative " weight­ of­ evidence" assessment. Quantitative estimates of risk are used in both; however, the " weight­ of evidence" assessment includes qualitative assessments of secondary risk based on mortality and other adverse effects reported in laboratory and field studies, operational control programs, and incident reports, as well as toxicokinetic data and residue levels reported in primary consumers. This approach is in concert with EPA's risk­ assessment guidelines2, where professional judgement or other qualitative evaluation techniques may be used to rank risks using categories such as low, medium, and high when exposure and effects data are limited or are not easily expressed in quantitative terms. COST/ BENEFITS OF USING RODENTICIDES Since FIFRA is a cost/ benefit statute, EPA should address the benefits of using rodenticides in this document. EPA summarized in its Rodenticide Cluster RED of July, 1998, the benefits of rodenticides specifically to include 1) health benefits ­ prevention of disease transmission, 2) 4 prevention of property damage and 3) prevention of rodent attacks on humans. I would like to add the benefit of rodenticides in restoring threatened and endangered species to island ecological systems. In regards to item 1), the CDC presented a report at the Rodenticide Stakeholder* s working group, June, 1999, that rodents directly cause hantavirus pulmonary syndrome, leptospirosis, ratbite fever, salmonellosis, yersinia pseudotuberculosis, lymphocytic choriomeningitis, trichinosis and toxoplasmosis. Rodents indirectly ( through harboring hosts such as fleas and mites) cause plague, rickettsialpox, Colorado tick fever, Rocky Mountain spotted fever, Lyme* s disease, relapsing fever, babesiosis, western equine encephalitis, California encephalitis, murine typhus, human granulocytic ehrlichiosis and cutaneous leishmaniasis. Concerning item 2) rodents are estimated to consume or contaminate with urine or droppings $ 1 billion of food in the U. S. annually. As noted in the above mentioned RED, rodents damage structures by gnawing on integral parts and contaminating them with bodily excretions. Rodents are also believed to account for 50% of fires of unknown origin by gnawing on electrical wiring. This was discussed by Dr. Robert Corrigan at a meeting of the above mentioned Rodenticide Stakeholder* s Working Group In regards to item 3) per the above mentioned RED, the number of cases of rats biting humans is estimated to be 14,000 per year. The CDC collected data showed that between 1986 and 1994, 809 non­ work related rat bites were reported to the New York City Department of Health. Two percent of rat bites require hospitalization and 95% require treatment. Finally, I would like to mention that Rodenticides are used in the restoration of natural ecosystems. Uninhabited islands in the United States have used brodifacoum to control rats. Hawaii is currently using diphacinone in its ecosystem restoration program. Non indigenous rodents ( often rats) threaten indigenous birds and plants. Rodenticides have been used and plans are being made to use them in the future to protect threatened indigenous birds and plants. EFED response: The Agency will be considering benefits later in the reregistration process, and the document has been modified to clarify that this is EFED's assessment of potential risks. OTHER ERROR CORRECTIONS In conclusion, I would like to add that HACCO has given its page by page review to the RRTF for inclusion with the RRTF* s comments and believes that itemization in this correspondence would be unnecessary repetition. However, we do want to emphasize, once again, that diphacinone* s acute oral toxicity for rats should be listed as 7.0 mg/ Kg. This is the number that should be used in EPA* s equations for ecological effects. It shows a bias on the Agency* s part to continue to list and to always use in its equations the rat acute oral LD50 of 2.5 and 2.1 mg/ Kg, the results of an unacceptable study. The Agency notified the registrants that this study was unacceptable. Our letter from EPA on the unacceptability of this study is dated February 6, 1992. 5 In the letter, it was stated that if the Agency* s question could not be answered, the Agency required that a replacement study be done. The accepted replacement study found the combined acute oral LD50 in rats to be 7.0 mg/ Kg. EFED response: HACCO provides no supporting documentation that this study is " unacceptable". The study is categorized as " supplementary" in the EPA/ OPP Health Effects Division's toxicity database; data from supplementary studies are used in OPP risk assessments. IN SUMMARY We urge EPA not to issue publicly this erroneous and incomplete document as EPA* s current statement of its Ecological Risk Assessment of Rodenticides, but rather to review our comments and the comments soon to be submitted by the RRTF and to make revisions accordingly.

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regulations

EPA-HQ-OPP-2002-0053-0001

Notice

Versar Inc. and ICF Consulting; Transfer of Data

Federal Register: May 8, 2002 ( Volume 67, Number 89)] [ Notices] [ Page 30916­ 30917] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr08my02­ 98] ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ENVIRONMENTAL PROTECTION AGENCY [ OPP­ 2002­ 0053; FRL­ 6836­ 9] Versar Inc. and ICF Consulting; Transfer of Data AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ SUMMARY: This notice announces that pesticide related information submitted to EPA's Office of Pesticide Programs ( OPP) pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) and the Federal Food, Drug, and Cosmetic Act ( FFDCA), including information that may have been claimed as Confidential Business Information ( CBI) by the submitter, will be transferred to Versar Inc. and its subcontractor, ICF Consulting, in accordance with 40 CFR 2.307( h)( 3) and 2.308( i)( 2). Versar Inc. and its subcontractor, ICF Consulting, have been awarded a contract to perform work for OPP, and access to this information will enable Versar Inc. and its subcontractor, ICF Consulting, to fulfill the obligations of the contract. DATES: Versar Inc. and its subcontractor, ICF Consulting, will be given access to this information on or before May 13, 2002. FOR FURTHER INFORMATION CONTACT: By mail: Erik Johnson, FIFRA Security Officer, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 305­ 7248; e­ mail address: johnson. erik@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action applies to the public in general. As such, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select Laws and Regulations,'' Regulations and Proposed Rules,'' and then look up the entry for this document under the Federal Register''­­ Environmental Documents. You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. II. Contractor Requirements Under Contract No. 68­ W0­ 1036, Versar Inc. and its subcontractor, ICF Consulting, will perform the following: Office of Pesticide Programs ( OPP) has the responsibility of reviewing Product and Residue Chemistry data submitted with applications for the registration of specific pesticide products, and new petitions for proposed uses or tolerances for currently registered or for new pesticides. The contractor shall provide back up support for these activities, which may include statistical evaluation of monitoring data, the review of data submitted in support of tolerance proposals, and the preparation of a summary and index system of previously completed EPA product and residue chemistry reviews by crop, data requirement, and/ or chemical to serve as a reference, policy and training guide. For this work assignment, the Contractor shall review data summaries and reformatted existing studies to identify data gaps and any studies that indicate adverse effects and conduct a thorough, comprehensive examination of all product chemistry and residue chemistry data of pesticides, including the chemistry and metabolism of pesticides in plants and animals and the resulting dietary exposure. The OPP has determined that access by Versar Inc. and its subcontractor, ICF Consulting, to information on all pesticide chemicals is necessary for the performance of this contract. Some of this information may be entitled to confidential treatment. The information has been submitted to EPA under sections 3, 4, 6, and 7 of FIFRA and under sections 408, and 409 of FFDCA. In accordance with the requirements of 40 CFR 2.307( h)( 2), the contract with Versar Inc. and its subcontractor, ICF Consulting, prohibits use of the information for any purpose not specified in the contract; prohibits disclosure of the information to a third party without prior written approval from the Agency; and requires that each official and employee of the contractor sign an agreement to protect the information from unauthorized release and to handle it in accordance with the FIFRA Information Security Manual. In addition, Versar Inc. and its subcontractor, ICF Consulting, are required to submit for EPA approval a security plan under which any CBI will be secured and protected against unauthorized release or compromise. No information will be provided to Versar Inc. and its subcontractor, ICF Consulting, until the requirements in this document have been fully satisfied. Records of information provided to Versar Inc. and its subcontractor, ICF Consulting, will be maintained by EPA Project Officers for this contract. All information supplied to Versar Inc. and its subcontractor, ICF Consulting, by EPA for use in connection with this contract will be returned to EPA when Versar Inc. and its subcontractor, ICF Consulting, have completed their work. [[ Page 30917]] List of Subjects Environmental protection, Business and industry, Government contracts, Government property, Security measures. Dated: April 25, 2002. Linda Vlier Moos, Acting Director, Information Resources and Services Division, Office of Pesticide Programs [ FR Doc. 02­ 11179 Filed 5­ 7­ 02; 8: 45 am] BILLING CODE 6560­ 50­ S

epa

2024-06-07T20:31:41.567301

regulations

EPA-HQ-OPP-2002-0055-0002

Supporting & Related Material

HED DOC. NO. 014533 DATE: April 10, 2001 SUBJECT: DISULFOTON: 3 rd Report of the Hazard Identification Assessment Review Committee FROM: David G. Anderson, Toxicologist Reregistration Branch­ 2 Health Effects Division ( 7509C) THRU: Jess Rowland, Chair and Elizabeth Doyle, Chair Hazard Identification Assessment Review Committee Health Effects Division ( 7509C) TO: Alan Nielsen, Branch Senior Scientist Reregistration Branch­ 2 Health Effects Division ( 7509C) PC Code: 032501 On December 19, 2000 and January 10, 2001 the Health Effects Division' s Hazard Identification Assessment Review Committee evaluated the toxicity data used for endpoints in short­ term occupational/ residential exposure. The Committee did not address other endpoints. The Committee' s conclusions are presented in this report. Members in Attendance Hazard Identification Assessment Review Committee members in attendance: William Burnam, , Beth Doyle, Pamela Hurley, Elizabeth Mendez, Ayaad Assaad, Yung Yang, Jonathan Chen, David Nixon, Jess Rowland and Brenda Tarplee ( Executive Secretary) . Data Presentation: and David G Anderson Report Preparation Toxicologist 1. INTRODUCTION On April 25, 1996 , the Health Effects Division' s RfD/ Peer Review Committee evaluated the toxicology data base of Disulfoton and established the Reference Dose ( RfD) of 0.0003 mg/ kg/ day based on a NOAEL of 0.025mg/ kg/ day and an Uncertainty Factor of 100 for inter species extrapolation and intraspecies variation ( Memorandum : G. Ghali to G. LaRoca, April 21, 1997) . On May 14, 1996, the Toxicology Endpoint Selection Committee selected the doses and endpoints for acute dietary and occupational as well as residential exposure risk assessments ( TES Document 6/ 5/ 96) . On November 20, 1997 , the Health Effects Division s Hazard Identification Assessment Review Committee ( HIARC) re­ evaluated the toxicology data base, re­ assessed the RfD and selected the toxicology endpoints for acute dietary as well as occupational and residential exposure risk assessments. In addition, the HIARC also addressed the potential enhanced susceptibility of infants and children from exposure to disulfoton as required by the Food Quality Protection Act ( FQPA) of 1996. On April 9, 1998 , the HIARC reviewed the results of a two­ generation reproduction study in rats ( MRID# 44440801) that was recently submitted to the Agency and the impact of this study in the doses and endpoints selected for the various risk assessments. On May 12­ 14, 1998 , the HIARC conducted a comprehensive review of 40 organophosphates, including disulfoton. At this meeting it was concluded that the toxicology database is inadequate since there was a data gap for an acceptable acute delayed neurotoxicity study in the hen. Subsequently, the requirement of a developmental neurotoxicity study was reserved at this time. . On January 19, 2000 , the HIARC reviewed the results of a new acute delayed neurotoxicity study in the hen. In addition, the equivocal results of a 90­ day neurotoxicity study in rats were reviewed for potential disulfoton induced neuropathy. HIARC also evaluated the toxicology data base for disulfoton to determine whether a DNT was triggered None of the endpoints for any of the RfDs or occupational or residential exposure were changed from the previous HIARC. On December 19, 2000 and January 11, 2001 , the HIARC reviewed the results from a 3­ day dermal toxicity study in rats ( recently submitted to the Agency) in conjunction with the available 21­ day dermal toxicity studies in rabbits. These studies were evaluated together to determine their suitability for use in short­ term dermal risk assessment. The report supercedes the previous HIARC reports 2. HAZARD IDENTIFICATION 2.1. Acute Reference Dose ( RfD) Study Selected: Acute Neurotoxicity ­ Rat § 81­ 8 MRID No. 42755801 Executive Summary: In an acute neurotoxicity screening study, disulfoton ( 97.8% a. i. ) was administered in a single gavage dose to 10 male Sprague­ Dawley rats at doses of 0, 0.25, 1.5, or 5.0 mg/ kg and to 10 female Sprague­ Dawley rats at doses of 0, 0.25, 0.75 or 1.5 mg/ kg. These rats were assessed for reactions in functional observational battery ( FOB) and motor activity measurements at approximately 90 minutes post­ dosing and on days 7 and 14. Cholinesterase determinations ( erythrocyte and plasma) were made at 24 hours post­ dosing. Six rats/ sex/ dose were examined for neuropathological lesions. At 0.75 mg/ kg, 4/ 10 females had muscle fasciculations. At 1.5 mg/ kg, males had muscle fasciculations, diarrhea, and sluggishness and females also had tremors, ataxia, oral staining, decreased activity/ sluggishness, decreases in motor and locomotor activity ( 38­ 49% of control) , and a slightly increased duration of nasal staining. One female at 1.5 mg/ kg died from cholinergic intoxication on the day of dosing. At 5.0 mg/ kg, males also had symptoms similar to those observed in females at 1.5 mg/ kg/ day, including reduced motor/ locomotor activity ( 36­ 45% of control) . Recovery appeared to be complete in surviving animals by Day 14. Based on the evidence of neurotoxicity ( probably associated with inhibition of cholinesterase) in females at 0.75 mg/ kg, the study LOAEL is 0.75 mg/ kg and the study NOAEL is 0.25 mg/ kg. At 0.75 mg/ kg in females, cholinesterase activities were inhibited by 53% ( erythrocyte) and 30% ( plasma) and by 75% ( erythrocyte) and 52% ( plasma) at 1.5 mg/ kg in females. At 5.0 mg/ kg in males, cholinesterase activities were inhibited by 21% ( erythrocyte) and 25% ( plasma) . The LOAEL for inhibition of cholinesterase activity is 0.75 mg/ kg and the NOAEL for inhibition of cholinesterase activity is 0.25 mg/ kg. Dose and Endpoints for Establishing the Acute RfD: NOAEL= 0.25 mg/ kg based on neurotoxicity signs, plasma and erythrocyte cholinesterase inhibition in female rats. Uncertainty Factor ( UF) : 100 Comments about the study and/ or Endpoint: This dose and endpoint is appropriate since the toxicological effects were observed following a single oral dose. Acute RfD = 0.25 mg/ kg ( NOAEL) = 0.0025 mg/ kg 100 ( UF) 2.2 Chronic Reference Dose Study Selected: Chronic Feeding Dog § 83­ 1 MRID No. 44248002 Executive Summary: In a chronic toxicity study, disulfoton ( 97% a. i. ) was administered orally in the diet to purebred beagle dogs ( 4/ sex/ dose) at dose levels of 0.5, 4 or 12 ppm ( equivalent to 0.015, 0.121 and 0.321 mg/ kg/ day for males; and 0.013, 0.094 and 0.283 mg/ kg/ day for females) for one year. Potential ocular and neurologic effects were addressed. Plasma cholinesterase was decreased starting at day 7 in the 4.0 ppm dose groups of the study through to termination ( males 39% to 46% ; females 32% to 45% ) . Erythrocyte cholinesterase was decreased starting at day 91 in the 4.0 ppm dose groups through to termination ( males 23% to 48% ; females 17% to 49% ) . Not all the values at 4.0 ppm were statistically significant, probably because of the wide range in values, but at least 2 animals per group showed biologically significant cholinesterase inhibition. By termination cholinergic effects of the plasma, erythrocytes, brain, and ocular tissues were observed in both sexes in the 4 and 12 ppm treatment groups. Plasma and erythrocyte cholinesterase depression are compared to pretreatment values. Brain, cornea, retina and ciliary body cholinesterase depression are compared with concurrent control values at termination only. In the 12 ppm treatment groups, depressed cholinesterase was observed in plasma ( 56% ­ 63% ) , erythrocytes ( 30% ­ 91% ) , and brain ( 32% ­ 33% ) compared to their respective controls. In the 4 ppm treatment groups in males and females, cholinesterase was depressed in plasma ( 38% ­ 46% ) , erythrocytes ( 40% ­ 38% ) , and brain ( females only, 22% ) . Disulfoton inhibited cholinesterase of the cornea, retina, and ciliary body, but did not appear to alter the physiologic function of the visual system. In the 12 ppm treatment groups, depressed cholinesterase was observed in the cornea ( 60­ 67% ) , ciliary body ( 45­ 54% ) , and retina ( males only; 67% ) . In the 4 ppm treatment groups, cholinesterase was inhibited in the cornea ( 50­ 60% lower) , and retina ( females only, 25% ) . No treatment­ related ophthalmology findings or histological or electrophysiological changes in the retina were observed. No other treatment­ related effects were observed. No animals died during the study. No treatment­ related effects were observed in systemic toxicity including food consumption, body weights, clinical signs, hematology, clinical blood chemistry or urinalysis parameters, electrocardiogram, electroretinograms or clinical neurological findings, organ weights or gross or microscopic post­ mortem changes in any treatment group. No neoplastic tissue was observed in dogs in the treatment and control groups. The LOAEL is 4 ppm ( 0.094 mg/ kg/ day) , based on depressed plasma, erythrocyte, and corneal cholinesterase levels in both sexes, and depressed brain and retinal cholinesterase levels in females. The NOAEL is 0.5 ppm ( 0.013 mg/ kg/ day) . These LOAEL/ NOAEL for plasma cholinesterase inhibition extend from day 7 to termination and for erythrocyte cholinesterase inhibition they extend from day 91 to termination. Dose and Endpoint for Establishing the Chronic RfD: The NOAEL is 0.5 ppm ( 0.013 mg/ kg/ day) based on depressed plasma, erythrocyte and corneal cholinesterase levels in both sexes and depressed brain and retinal cholinesterase levels in females. Uncertainty Factors ( UF) : 100 Chronic RfD = 0.013 mg/ kg ( NOAEL) = 0.00013 mg/ kg/ day 100 ( UF) 2.3. Occupational/ Residential Exposure 2.3.1. Dermal Absorption; § 85­ 2 MRID No. : 43360201 The test material was applied to the backs of rats at 0.85, 8.5, and 85 F g/ cm 2 ( approximately 0.051, 0.51 and 5.1 mg/ kg) . The percent of absorbed dose at 10 hours post­ application was 26, 36, and 25% , respectively. Dermal Absorption Factor : 36% Comments about the Study Endpoint : The HIARC indicated that dermal absorption of 36% , obtained after 10 hours exposure at a concentration of 8.5 F g/ cm 2 ( 0.51 mg/ kg) , should be used for correcting oral dosing to dermal dosing. The HIARC concurred with the TES Committee on this approach for the use of the dermal absorption factor. HIARC deviated from the standard practice of using the 10­ hour dermal absorption value from the lowest application rate in this case because of the lack of a coherent pattern of absorption normally observed in dermal absorption studies. In most cases, the lowest application rate results in the highest dermal absorption rate, with declining absorption at higher applications. This is assumed to reflect overloading of the site of application. In as much as there was no dose­ related pattern to the percent of disulfoton absorbed, HIARC elected to use the 36% absorption rate to reduce the likelihood of underestimation. 2.3.2 Short Term Dermal ­ ( 1­ 7 DAYS) Study Selected: 3­ day dermal study in rats MRID No. 45239602 Executive Summary: In a 3­ day dermal rat study ( MRID# 45239602) disulfoton, granular, 1% a. i. ( 1% G Di­ Syston ® ) was administered dermally to 5 Wistar ( Crl: WI( HAN) BR) rats/ sex/ dose at 0, 50, 100, 200 or 500 mg/ kg/ day ( equivalent to 0, 0.5, 1.0, 2.0 or 5.0 mg a. i. / kg/ day) . Plasma and erythrocyte cholinesterase was measured at 24 hours after the first and day 3 dose. Brain cholinesterase was measured at termination on day 4. Test material was ground and applied to plastic backed gauze, moistened with water, applied to the shaved test site ( about 10% of the body surface) , and then secured with a bandage. The animals were exposed dermally for 6 hour per day with washing at the end of the exposure period. No clinical signs were noted or body weight decrement. No other signs of toxicity were noted, but the study was designed to determine cholinesterase depression only. After 1 day of dosing, the NOAEL in males was 200 mg/ kg and the LOAEL was 500 mg/ kg based on biologically significant 31% erythrocyte cholinesterase inhibition which was not statistically significant. After 1 day of dosing the NOAEL in females was 100 mg/ kg and the LOAEL was 200 mg/ kg based on biologically significantly increased inhibition of plasma cholinesterase ( 36% ) . After 3­ days of dermal dosing the NOAEL in males was 100 mg/ kg/ day and LOAEL was 200 mg/ kg/ day based on a increase in brain cholinesterase inhibition of 21% ( statistically significant) . After 3 days of dosing the NOAEL in females was 50 mg/ kg/ day and the LOAEL was 100 mg/ kg/ day based on statistically significant plasma and brain cholinesterase inhibition of 37% and 18% , respectively. The overall NOAEL of 100 mg/ kg/ day ( equivalent to 1.0 mg a. i. / kg/ day) with a LOAEL of 200 mg/ kg/ day ( equivalent to 2.0 mg a. i. / kg/ day) was based on female plasma cholinesterase depression for 1 day of dosing. After 3 days of dosing the NOAEL was 50 mg/ kg/ day ( equivalent to 0.50 mg a. i. / kg/ day) with a LOAEL of 100 mg/ kg/ day ( equivalent to 1.0 mg a. i. / kg/ day) based on depressed plasma and brain cholinesterase in females. The study is acceptable for selecting a regulatory endpoint although neither a 1­ day nor a 3­ day dermal study in the rat is a guideline study. Dose and Endpoint for risk assessment: The NOAEL = 0.5 mg/ kg/ day based on plasma and brain cholinesterase inhibition in females rats at 1.0 mg/ kg/ day ( LOAEL) . Comments about the study and/ or endpoint: The 3­ day dermal study was the most appropriate for several reasons. It was conducted in the appropriate species. Cholinesterase was seen in two compartments, plasma and brain. The LOAEL of 1.0 mg/ kg/ day in the selected study is supported by the LOAELs in the 1988 and 1986 21­ day dermal studies in the rabbit of 1.0 and 1.6 mg/ kg/ day, respectively at day 8 to 15. The test material consisted of the granular material to which the handlers are exposed. A 21­ day dermal toxicity study in rabbits ( 1988) with a NOAEL = 0.8 mg/ kg/ day and a LOAEL = 1.0 mg/ kg/ day ( based upon plasma cholinesterase inhibition at Day 8) was not selected for this endpoint. The NOAEL for this study overlapped the LOAEL in the developmental toxicity study in rats, suggesting that the rat is more sensitive than the rabbit to the effects of disulfoton. Therefore, the HIARC selected the NOAEL from the 3­ day dermal study in rats. In addition, the NOAEL of 0.5 mg/ kg/ day was selected in preference to the 0.3 and 0.4 mg/ kg/ day NOAELs from the developmental toxicity study in rats and the 21­ day dermal study in rabbits ( 1986) because the LOAELs from all three studies were similar and the spread between 0.3 and 0.5 mg/ kg/ day is likely due to dose selection and does not reflect differential toxicity. 2.3.3 Intermediate Term Dermal Exposure ( 1 Week to Several Months) : Study Selected ­ Special 6­ months cholinesterase study MRID No. : 43058401 Executive Summary: In a 6­ month study designed to establish a NOAEL and LOAEL for cholinesterase inhibition, technical grade disulfoton ( 98­ 99% a. i. ) was administered in the diet to 35 male and female Fisher 344 rats for up to 6 months at levels of 0, 0.25, 0.5 or 1 ppm ( approximate doses of 0, 0.02, 0.03 or 0.06 mg/ kg/ day for males and 0, 0.02, 0.03 or 0.07 mg/ kg/ day for females) . At the end of 2, 4 and 6 months, 10 rats/ sex/ dose were taken for blood and brain cholinesterase assays. Statistically significant inhibition of cholinesterase activity was observed in erythrocytes in females at all doses ( 3­ 14% inhibition, 11­ 17% inhibition, and 23­ 29% inhibition at 0.24, 0.5, and 1.0 ppm, respectively. In addition, at 1.0 ppm, males had decreased erythrocyte cholinesterase activity ( 10­ 16% inhibition) and females had decreased plasma ( 8­ 17% inhibition) and brain ( 7­ 13% inhibition) cholinesterase activities. However, biologically significant and statistically significant inhibition of cholinesterase activity was observed only in the plasma, erythrocytes and brain of females at 1.0 ppm. No biologically significant inhibition of cholinesterase activity was observed in males. The LOAEL for inhibition of cholinesterase activity was 1.0 ppm is based on a 23­ 29% inhibition of erythrocyte, 12­ 17% inhibition of plasma and 13% inhibition of brain cholinesterase in females. The NOAEL is 0.5 ppm ( 0.03 mg/ kg/ day) . No biological meaningful cholinesterase inhibition was observed in males at any dose level. Body weight, food consumption, and clinical signs were also monitored, but showed no treatment related effects. Based on these few parameters, no systemic effects were observed at any dose level and the NOAEL for systemic toxicity was 1.0 ppm ( 0.06 mg/ kg/ day for males and 0.07 mg/ kg/ day for females) . Dose and Endpoint for use in risk assessment: NOAEL= 0.03 mg/ kg/ day was based on plasma, erythrocyte and brain cholinesterase inhibition in female rats at 0.07 mg/ kg/ day ( LOAEL) . Comments about study and/ or endpoint: Since an oral NOAEL was identified, a dermal absorption factor of 36% should be used for this risk assessment. This endpoint is supported by similar effects ( plasma, erythrocyte and brain cholinesterase inhibition) observed in a subchronic neurotoxicity study in rats ( MRID# 42977401) . A comparison of the oral developmental studies with the oral 90­ day neurotoxicity study ( MRID# 42977401) shows a relationship between increased cholinesterase inhibition with increased duration of the study. The dermal equivalent of LOAEL of 0.2 mg/ kg/ day in the 90­ day study ( i. e. , 0.07 mg/ kg/ day ÷ 0.36 = = 0.2 mg/ kg/ day) at 4 weeks is lower than the LOAEL from either the 1986 ( LOAEL= 1.6 mg/ kg/ day) or the 1988 21­ day rabbit dermal studies ( LOAEL= 1.0 mg/ kg/ day) at the end of 3 weeks. These comparisons support the generally held perception that rabbit dermal studies tend to underestimate toxicity from an organo­ thiophosphate pesticide. The new 2­ generation study on reproduction ( MRID# 44440801) also supports the 6­ month cholinesterase study endpoints. 2.3.4. Long­ Term Dermal ( Several Months to Life Time) Study selected: Chronic Toxicity ­ Dog § 83­ 1 MRID No. 44248002 Executive Summary: See summary under Chronic RfD. Dose and Endpoint for Risk Assessment: NOAEL= 0.013 mg/ kg/ day based on depressed plasma, erythrocyte and corneal cholinesterase levels in both sexes and depressed brain and retinal cholinesterase levels in females. Comments about study and/ or endpoint : This dose was used to establish the chronic RfD. Since an oral NOAEL was identified, a dermal absorption factor of 36% should be used for this risk assessment. 2.3.5. Inhalation Exposure ( All Time Periods) Study Selected: 90­ Day Inhalation ­ Rat § 82­ 4 MRID No. : 41224301 Executive Summary: Disulfoton was administered by inhalation to 12 Fisher 344 rats per sex per group for air control, polyethylene glycol­ 400: 50% ethanol vehicle control, 0.015, 0.15 or 1.5 mg/ m 3 nominal dose levels for 90­ days in a nose only chamber. The analytical determined mean dose levels were 0, 0, 0.018, 0.16 and 1.4 mg/ m 3 for male and female rats. The rats were exposed to the test material 6 hours per day, 5 days per week. The particle sizes in the inhalation chambers had a MMAD ± geometric standard deviation of 1.3 ± 1.4, , 1.1 ± 1.3, , 1.0 ± 1.3 and 1.1 ± 1.4 F m for the two controls, 0.015, 0.15 and 1.5 mg/ m 3 nominal dose levels, respectively. The range in mean daily particle sizes had a MMAD of 0.5 ± 1.0 F m to 2.6 ± 1.6 F m. At the highest dose level, plasma cholinesterase was depressed in males ( 19% and 14% from air controls at 38 days and term, respectively, p # 0.05) and in females ( 27% and 31% from air controls at 38 days and term, respectively, p # 0.05) . Brain cholinesterase was depressed in males ( 29% ) and females ( 28% ) at termination. Erythrocyte cholinesterase was depressed in females at 38 days ( 11% at 38 days, p # 0.05, not considered biologically relevant) at 0.16 mg/ m 3 and higher in males and females at 1.4 mg/ m 3 at 38 days and term. Brain cholinesterase was depressed ( 10% , p # 0.05) at 0.16 mg/ m 3 , but this degree of variation was not considered biologically relevant due to variation noted in this parameter. Inflammation of the male nasal turbinates occurred at 1.4 mg/ m 3 . No other test material related effects were noted. The NOAEL/ LOAEL is 0.16/ 1.4 mg/ m 3 for plasma, erythrocyte and brain cholinesterase depression in males and/ or females. Dose and Endpoint for use in risk assessment: NOAEL= 0.00016 mg/ L based on plasma, erythrocyte and brain cholinesterase inhibition. The rat inhalation NOAEL when converted to mg/ kg is 0.045 mg/ kg/ day. Conversion 1 of mg/ L to mg/ kg/ day using route­ to­ route extrapolation policy. [ 0.00016 mg/ L ( NOAEL) x 1( fractional absorption) x 7.15 L/ hr ( respiratory volume for Fisher 344 rats) x 6( hours) x 1( activity factor) ] / [ 0.152 kg ( body weight) ] = = 0.045 mg/ kg. Comments about the study and/ or endpoint: This NOAEL will be used for inhalation exposure risk assessments for any time period ( i. e. , Short, Intermediate and Long­ term) . An inhalation toxicity study with 3 to 5 day exposure was available. In that study, the LOAEL was < 0.0005 mg/ L ( lowest dose tested) ; a NOAEL was not established. Although this study could have been used for the Short­ Term exposure risk assessment, the HIARC did not use this study because: ( i) it demonstrated a LOAEL rather than a NOAEL; ( ii) the use of a LOAEL would have required an additional 3 x UF; and ( iii) the value derived from the use of the LOAEL and 3 UF ( 0.0005 ÷ 3= 0.00017 mg/ L) is comparable to the NOAEL of 0.00016 mg/ L in the 90­ day study. Memorandum of 10/ 10/ 98 from John Whalan to Stasikowski, HED. Route­ to­ Route Extrapolation, page 8. 2.3.6. Margins of Exposure for ( Occupational/ Residential) Exposures A Margin of Exposure ( MOE) of 100 is adequate for occupational exposure risk assessments. The FQPA Safety Committee determined that an MOE of 100 is adequate for residential exposure risk assessments. 2.4. Recommendation for Aggregate Exposure Risk Assessment For acute, short, intermediate and long­ term de aggregate exposure risk assessment, the oral, dermal and inhalation routes can be combined since a common toxicological endpoint ( cholinesterase) was observed during all routes of exposure ( oral, dermal and inhalation) in the toxicity studies. 3. CLASSIFICATION OF CANCER POTENTIAL The HED RfD/ Peer Review classified disulfoton as a Group E Chemical­ Not Classifiable to Carcinogenicity based on the lack of evidence of carcinogenicity study in mice and rats at dose levels adequate to test for carcinogenicity. 4. MUTAGENICITY The following was taken from a document written by Nancy McCarroll for the Hazard Identification Assessment Review Committee proceedings. Combining the acceptable studies with the additional EPA­ sponsored studies will satisfy the Pre­ 1991 mutagenicity initial testing battery guidelines. No further mutagenicity testing has been identified at this time. In addition, disulfoton is not genotoxic in vivo or carcinogenic in mice or rats. In some of the mutagenicity studies, positive effects were seen without activation while negative effects were seen with activation. This may be due to microsomal enzyme metabolism, since pretreatment of rats and mice with phenobarbital reduces toxicity from disulfoton. 4.1 Gene Mutation ( 84­ 2) Salmonella typhimurium/ Escherichia coli reverse gene mutation plate incorporation assay ( Accession No. 00028625; Doc. No. 003958: As part of an Agency sponsored mutagenicity screening battery, disulfoton was negative in all strains up to the HTD ( 5000 F g/ plate + / ­ S9) in three independent trials. Chinese hamster ovary ( CHO) cell HGPRT forward gene mutation assay ( MRID# 40638401, Doc# 008394) : This unacceptable study is considered to be positive, because the assay was conducted at partially soluble levels( 0.1­ 1.0 F L/ ml ­ S9; 0.7­ 1.0 F L/ ml + S9) and insoluble doses ( 5­ 10 F L/ ml ­ S9; 3­ 10 F L/ ml + S9) but not active at soluble concentrations ( # 0.06 F L/ ml + / ­ S9) . The mutagenic response appeared to be stronger without metabolic ( S9) activation . 4.2 Chromosome Aberrations ( 84­ 2) Mouse micronucleus test ( MRID No. 43615701) No increase over background in micronucleated polychromatic erythrocytes ( evidence of cytogenetic damage) of mice treated intra­ peritoneally up to MTD levels ( 8 mg/ kg) . Lethality and other signs of toxicity, but no bone marrow cytotoxicity was seen. 4.3 Other Gene Mutations : ( 84­ 2) Bacterial DNA Damage/ Repair: E. Coli DNA damage/ repair test ( Accession# 072293; Doc# 004698) : The test is negative up to the HDT ( 10,000 F g/ plate + / ­ S9. Mitotic Recombination: Saccharomyces cerevisiae D3 mitotic recombination assay ( Accession# 00028625; Doc# 003958) : Disulfoton ( up to 5% + / ­ S9) was negative at this endpoint in the Agency­ sponsored mutagenicity screening battery. The study is currently listed as unacceptable, but should be upgraded to acceptable. Upon further review of the data, it was decided that the reason for rejecting the study ( number of replicates/ dose not provided) did not interfere with the interpretation of the findings. Sister Chromatid Exchange: Sister chromatid exchange in CHO cells ( MRID# 4095001; Doc# 008394) : Positive, dose related effects at 0.013­ 0.1 F L/ ml without S9, but not active in the S9 activated phase of testing up to a level ( 0.20 F L/ ml) causing cell cycle delay. Sister Chromatid Exchange: Sister chromatid exchange in Chinese hamster V79 cells ( Accession# 072293; Doc# 0044223) : The test is negative without activation up to the HTD ( 80 F g/ ml) . Subsequently tested by the same investigators ( Chen et al. , 1982; Environ. Mutagen. 4: 621­ 624) in the presence of exogenous metabolic activation and found to be negative up to the HDT ( 80 F g/ ml) . Unscheduled DNA Synthesis ( UDS) : UDS in WI­ 38 human fibroblasts ( Accession# 000028625; Doc# 003958) : The test is positive in the absence of S9 activation at precipitating doses ( 1000­ 4000 F g/ ml) . With S9 activation, the study was negative at comparable percipitating concentrations. 4.4 Other EPA Sponsored Studies: Disulfoton was also included in second tier mutagenicity test battery performed at the EPA ( EPA­ 600/ 1­ 84­ 003) in 1984. Although DERs have not been prepared for these additional assays, we assess that they are acceptable for regulatory purposes. Mouse Lymphoma L5178Y TK+ / ­ forward gene mutation assay: The test was positive in the absence of S9 activation with concentration dependent and reproducible increases in mutation frequency at 40­ 90 F g/ ml; higher dose levels were cytotoxic. No mutagenic activity was seen in the presence of S9 activation up to a cytotoxic dose ( 150 F g/ ml) . Mouse Micronucleus Assay: The test is negative in Swiss Webster mice up to a lethal dose ( 8 mg/ kg) administered once daily for 2 consecutive days by intra­ peritoneal injection. No bone marrow cytotoxicity was seen. Sister Chromatid Exchange in CHO cell assay: The non­ activated test was negative up to levels ( $ 0.02% ) that caused cell cycle delay, but the test material was weakly positive at a single dose ( 0.04% ) with metabolic activation. 5. FQPA CONSIDERATIONS 5.1. Adequacy of the Data Base The toxicity data base is adequate to determine the neurotoxic potential from disulfoton exposure, except for developmental neurotoxic potential. A developmental neurotoxicity study for organophosphates, including disulfoton is required. 5.2. Neurotoxicity Another acute delayed neurotoxicity study ( 81­ 7) was submitted and reviewed and is acceptable. The study is negative for organophosphate induced delayed neuropathy ( OPIDN) . Absolute brain weight was not affected by treatment in the guideline chronic studies in rodents. ( The subchronic studies, which were graded unacceptable, were not provided for review. ) In the rat study, treatment­ related eye lesions were seen ( optic nerve degeneration and corneal vascularization) and skeletal muscle atrophy were observed. The optic nerve degeneration was related to orbital sinus bleeding injury, so results were not considered treatment related. These neuropathological findings were not repeated in the 1997 1­ year dog study, but cholinesterase levels in the cornea, retina, and ciliary body were depressed with treatment. No treatment related neuropathy was seen in acute or in 90­ day neurotoxicity studies in rats. The marginal elevation in lesions seen the optical nerve and thoracic spinal cord at the highest dose tested were not considered to be sufficiently different from control lesions to indicate a treatment­ related effect had occurred. The repeat ? acute delayed neurotoxicity study in hens ? requested by the HIARC of April 23, 1998 is summarized below. In an acute delayed neurotoxicity study in hens ( MRID# 44996401, 1999) , disulfoton was acutely administered orally to 18 LSL laying hens at 40 mg/ kg bird in a single dose. Fifteen hens were used as controls. Doses were administered in aqueous 2% Cremophor at 5 ml/ kg bird. Five to 18 minutes before administration of the disulfoton, atropine was administered s. c. ( 0.5 ml/ kg of 4% atropine sulfate) . Directly prior to the administration of the disulfoton, 0.5 ml/ kg of 10% atropine sulfate and 10% 2­ PAM chloride was injected s. c. The afternoon of day 0, 0.5 ml/ kg of 5% atropine sulfate and 5% 2­ PAM chloride was injected s. c. and again the morning and afternoon of day 1. Clinical observations were made at least daily. Forced motor activity tests were conducted by forcing the hens to run around a 12­ 13 m 2 area and rated for coordination, ataxia, and paresis. NTE studies were conducted at 24 and 48 hours on the spinal cords, sciatic nerves and ½ of the brain in each of 3 hens per group. . Cholinesterase activity studies were conducted on the other ½ of the brain from each bird in the NTE study at 24 and 48 hours post treatment. The study was conducted at 1.4 times the LD50 for hens. No typical signs of organophosphate induced delayed neuropathy was seen during the study or on microscopic examination of the treated birds at termination at 3 weeks. No inhibition was seen in the NTE study at 24 hours or 48 hours. Inhibition was low between 4% and 8% and was not considered to be indicative of OPIDN. Cholinesterase activity in the brain was inhibited 83% and 59% at 24 and 48 hours, respectively. No hens died, but by day 7 there was a decrease in body weight of over 5% . The hens slowly recovered and by the end of 3 weeks, body weight of the treatment group and of the controls did not differ. Severely uncoordinated gait was observed in all treated birds within 5 minutes of being dosed with atropine and before disulfoton treatment. The report authors attributed this abnormal gait to atropine since it lasted only for the duration of the atropine treatment ( 2 days) . However, the report authors also noted reduced motility in 1­ 3 birds for 0­ 1 day, which they attributed to disulfoton treatment. Neither statements are completely supportable because the hens were dosed with atropine and disulfoton during most of this period. However, the temporary uncoordinated gait was followed by no microscopic findings in nerve tissue and no other signs, which supports a conclusion of no demonstrated OPIDN in hens dosed with disulfoton. Microscopic examination of the test birds showed 3 brain ( 25% ­ 8% in each region, grade 1) lesions in treated birds and 1 ( 11% , grade 1) in the same control brain regions. Since these lesions were similar to those found in controls from previous studies, they were considered incidental. The study supports a conclusion the disulfoton does not cause acute delayed neuropathy ( OPIDN) in hens. The study is acceptable for an acute delayed neurotoxicity study ( OPPTS# 870.6100) in hens. In an acute neurotoxicity study in Sprague­ Dawley rats ( 10/ sex/ group) , 97.8% disulfoton was administered by a single gavage dose of 0.25, 1.5, or 5.0 mg/ kg in males and 0.25, 0.75, or 1.5 mg/ kg in females. The NOAEL for neurotoxicity and cholinesterase inhibition was 0.25 mg/ kg, based on muscle fasciculations in 4/ 10 females and plasma and RBC cholinesterase inhibition at the LOAELs of 0.75 mg/ kg in females and 1.5 mg/ kg in males. The incidence and type of clinical, behavioral, and neuromotor signs increased with dose. Females were clearly more sensitive. Neither brain weight nor neuropathology was affected by treatment ( MRID 42755801) . In a 90­ day subchronic neurotoxicity study, 98.7­ 99.0% disulfoton was administered to Fisher 344 rats ( 1 2/ sex/ group) at dietary levels of 1, 4, or 16 ppm ( 0.063, 0.270, or 1.08 mg/ kg/ day in males and 0.071, 0.315, or 1.31 mg/ kg/ day in females) . The systemic NOAEL was 1 ppm ( 0.063/ 0.071 mg/ kg/ day for M/ F) , based upon clinical signs consistent with cholinesterase inhibition ( muscle fasciculations, urine staining, increased food consumption) in females at the LOAEL of 4 ppm ( 0.270/ 0.315 mg/ kg/ day in M/ F) . At 16 ppm ( 1.08/ 1.31 mg/ kg/ day in M/ F) , treatment­ related findings in both sexes also included increased reactivity, perianal staining, tremors, increased defecation, decreased forelimb grip strength, decreased motor and locomotor activity, decreased body weight gain, and corneal opacities. Cholinesterase inhibition ( plasma, erythrocyte, and brain) was observed at all treatment levels ( ChE NOAEL< 1 ppm; 0.063/ 0.071 mg/ kg/ day for M/ F) . Clearly females were again shown to be more sensitive. It was noted that clinical signs were persistent throughout this study. There were no treatment­ related effects on brain weight. At the high­ dose level, neuropathological lesions ( nerve fiber degeneration) were observed in the optic nerve, and nerve fiber degeneration was also observed in the thoracic spinal cord. These findings, however, with similar neuropathy in control rats, the marginal increase in these lesions at the highest dose tested were not sufficiently different control lesions to indicate that treatment­ related effect had occurred ( MRID 42977401) . 2. Developmental Toxicity In a prenatal developmental toxicity study in Sprague­ Dawley rats ( 25/ group) , 98.2% disulfoton was administered on gestation days 6­ 15 by gavage in polyethylene glycol 400 at dose levels of 0.1, 0.3, or 1.0 mg/ kg/ day. Cholinesterase activity was measured in dams ( 5/ group) on gestation day 15. The maternal NOAEL was 0.1 mg/ kg/ day, and the maternal LOAEL was 0.3 mg/ kg/ day, based on 41% inhibition of plasma and RBC cholinesterase. There was no other evidence of maternal toxicity at any treatment level. The developmental NOAEL and LOAEL were established at 0.3 and 1.0 mg/ kg/ day, based on incomplete ossification of the intraparietals and sternebrae ( MRID 00129458) In a prenatal developmental toxicity study conducted in New Zealand white rabbits ( 15­ 22/ group) , 97.3% disulfoton was administered by gavage in corn oil ( 5 ml/ kg) at doses of 0.3, 1.0, or 3.0 ( reduced to 2.0, then 1.5) mg/ kg/ day on gestation days 6­ 18. The maternal NOAEL was 1.0 mg/ kg/ day; the maternal LOAEL ( 1.5 mg/ kg/ day) was based upon clinical signs of cholinesterase depression ( tremors, unsteadiness/ incoordination, and increased respiration, occurring within 4 hours of dosing) . In addition, there were a large number of mortalities at the high­ dose level. There was no evidence of developmental toxicity ( developmental NOAEL > 1.5 mg/ kg/ day) . Neither maternal nor fetal cholinesterase levels were measured ( MRID 00147886) . 3. Reproductive Toxicity: In a two­ generation reproduction study in Sprague­ Dawley rats ( 25/ sex/ group) , 97.8% disulfoton was administered at dietary concentrations of 1, 3, or 9 ppm ( calculated effective doses of 0.81, 2.4, or 76.3 ppm; equivalent to 0.04, 0.12, or 0.36 mg/ kg/ day by test material consumption) . The parental systemic NOAEL was 3 ppm ( 0.12 mg/ kg/ day) . The parental systemic LOAEL was 9 ppm ( 0.36 mg/ kg/ day) , based on decreased females mated and reduced body weight during gestation and lactation in P females. The offspring NOAEL was 1 ppm ( 0.04 mg/ kg/ day) , and the offspring LOAEL was 3 ppm ( 0.12 mg/ kg/ day) , based on decreased brain cholinesterase activity in F1a weanling pups and on decreased F2b pup survival. Although adult cholinesterase was not measured, the 2­ year chronic study indicates that cholinesterase inhibition was most likely occurring at 3 ppm with a NOAEL of 1 ppm; this was a conclusion of the 4/ 25/ 96 RfD PRC meeting ( MRID 00157511) . In a another 2­ generation reproduction study, disulfoton, technical ( 99% a. i. ) was administered to 30 Sprague­ Dawley rats/ sex/ dose in the diet at dose levels of 0, 0.5, 2.0 or 9.0 ppm ( 0, 0.025, 0.10 or 0.45 mg/ kg/ day by std. tables) . Dosing was continuous for the P0 and F1 generation. Only one littering/ animal/ group was conducted. In this second 2­ generation reproduction toxicity study with disulfoton, cholinesterase activity was measured in adults during pre­ mating ( at 8 weeks) and at termination and in pups at postnatal day 4 and day 21 in both generations. The major effects noted were cholinesterase inhibition and dams with no milk. In P0 males, plasma cholinesterase ( PCHE) was significantly depressed and dose related pre­ mating at 9.0 ppm ( $ ­ 34% ) and at termination at 2.0 ( $ 11 ) and 9.0 ppm ( ­ 46% ) . In P0 females, plasma cholinesterase ( PCHE) was significantly depressed pre­ mating ( $ ­ 29% ) and at termination ( $ ­ 52% ) at $ 2.0 ppm. In P0 males and females erythrocyte cholinesterase ( ECHE) was significantly depressed and dose related at $ 2.0 ppm ( $ ­ 38% & $ ­ 35% males and $ ­ 46% & $ ­ 80% females) a pre­ mating and termination, respectively, but only in females at termination ( $ ­ 14% ) at $ 0.5 ppm. In P0 males and females brain cholinesterase ( BCHE) was significantly depressed and dose related at $ 2.0 ppm in males ( $ ­ 11% ) and $ ­ 14% in females at $ 0.5 ppm. PCHE and ECHE depression in F1 males and females followed a similar nominal pattern to that in P0 males and females, except that the statistical significance varied within the F1 between two dose levels; sometimes the dose level showing statistical significance was higher and sometime lower of the two. In F1 males and females, BCHE was significantly depressed and dose related at $ 2.0 ppm in males ( $ ­ 14% ) and in females ( $ ­ 50% ) . In F1 and F2 male and female pups at day 4 and/ or day 21 of lactation, PCHE and ECHE were significantly depressed at 9.0 ppm. Values for PCHE and ECHE, respectively were at day 4 or day 21 in F1 male pups were ( ­ 24% & ­ 47% ) and for F1 female pups ( ­ 31% & ­ 43% ) . Values for PCHE and ECHE, respectively, were at day 4 or day 21 in F2 male pups were ( ­ 46% & ­ 53% ) and for F2 female pups ( ­ 48% & ­ 51% ) . In F1 and F2 male and female pups BCHE was significantly depressed at day 4 and day 21 at 9.0 ppm only ( day 4 = ­ 14% F1 males and ­ 17% F1 females) ( day 21 = ­ 19% F1 males and ­ 23% F1 females) ( day 4 = ­ 11% F2 males and ­ 13% F2 females) ( day 21 = ­ 35% F2 males and ­ 37% F2 females) . Muscle fasciculation ( one P0 female) , tremors ( 15 P0 females, ten F1 females) and dams ( seven F1 dams) with no milk were noted at 9.0 ppm. No treatment related organ weight changes or histopathology were noted in P0 or F1 males or females at any dose level. Clinical observations indicate that dams were not caring for their pups. Observed affects in pups in the 9.0 ppm group included 12 F1 ( two dams) pups cold to the touch and three F1 ( two dams) not being cared for and 63 F2 pups ( seven dams) with no milk in their stomachs and 93 F2 weak pups ( ten dams) from the affected dams. In addition, one P0 dam was salivating and gasping and did care for the litter and the litter died at 2.0 ppm. This effect at 2.0 ppm was considered test material related by the summary author of the 6( a) ( 2) submission ( See summary 6( a) ( 2) report, MRID# 44440801; memorandum from David Anderson to PM 53, dated March 24, 1998, D242573) , but ignored in the final report summary. Findings at necropsy were noted in F2 pups at 9.0 ppm that were expected in view of the maternal toxicity at this dose level. The report reasonably considered the pup deaths due to failure of maternal care, because of the weak and cold to the touch pups and failure of the pups to show milk in their stomachs. On careful examination of the report, this reviewer agrees with this conclusion. Thus, under these conditions, the effects in pups were caused by maternal toxicity and not the direct toxicity of disulfoton on pups. Body weight change was lower than control values during gestation in P0 ( ­ 9% ) and F1 ( ­ 15% ) females. Body weights were significantly reduced at termination from control values in P0 ( ­ 6% ) and F1 females ( ­ 13% ) and in F1 males ( ­ 8% ) . No other significant body weights or changes were noted. The P0 parental LOAELs were 0.5 ppm ( 0.025 mg/ kg/ day) based on brain cholinesterase activity depression in P0 females with tremors and muscle fasciculation at 9 ppm in females during gestation and lactation from both generations and with body weight decrements at 9.0 ppm, especially at termination. A NOAEL of 0.5 ppm ( 0.025 mg/ kg/ day) was seen in F1 parents. F1 and F2 pup ( 4 days and 21 days old) cholinesterase activity, including brain cholinesterase activity was depressed only at 9.0 ppm ( 0.45 mg/ kg/ day) with 2.0 ppm ( 0.10 mg/ kg/ day) being the NOAEL. The F1 pup NOAEL/ LOAEL were 2.0/ 9.0 ppm ( 0.10/ 0.45 mg/ kg/ day) based on treatment related pup deaths and pup weight decrements at 9.0 ppm, probably from inadequate maternal care ( MRID# 44440801) . 4. Additional Information from the Literature This summary is provided to develop a comprehensive picture of disulfoton toxicity. The data have not been reviewed in depth, and no statement is made regarding the accuracy or quality of the data or reports. In a 1988 study by McDonald et al. , disulfoton was administered by daily i. p. injection at 2 mg/ kg/ day to male Long­ Evans rats for 14 days. In treated rats, muscarinic receptor binding was decreased and spacial memory was decreased in a T­ maze alternation task. 5. Determination of Suseptibility There is no quantitative or qualitative evidence of increased susceptibility of fetuses following in utero exposure to rats and rabbits and during pre/ post natal exposure to rats. In these studies, toxicity to the fetus or pups occurred only at higher dose levels than to the dams ( mothers) or parents. 6. Recommendation for Developmental Neurotoxicity Study A developmental neurotoxicity study with disulfoton is required by the Data Call­ In Notice ( September 10, 1999) for select organophosphates. 7. Determination of the FQPA Safety Factor: The FQPA Safety Factor Committee met on January 24, 2000 to re­ evaluate the hazard and exposure data for disulfoton, and recommended that the FQPA Safety Factor ( as required by Food Quality Protection Act of August 3, 1996) be removed ( 1x) in assessing the risk posed by this chemical. The FQPA safety factor recommendation in this report supercedes that previously reported for disulfoton in the FQPA SAFETY FACTOR RECOMMENDATIONS FOR THE ORGANOPHOSPHATES dated August 6, 1998. 6. DATA GAPS Developmental neurotoxicity study as required by the Data Call­ In Notice ( September 10, 1999) 7. HAZARD CHARACTERIZATION Cholinesterase inhibition ( plasma, erythrocyte and/ or brain) is seen at the lowest dose levels tested in rats, mice, rabbits and dogs. All of the endpoints are based on good dose related responses in cholinesterase inhibition. Many of the studies show clinical signs at higher dose levels. Females appear to be more sensitive to cholinesterase inhibition in most studies. The organophosphates have a common mode of action in that they decrease erythrocyte and/ or brain cholinesterase in animals and humans. Plasma cholinesterase inhibition is a surrogate for possible muscle and brain cholinesterase inhibition. Neuropathy may result from higher exposures to these inhibitors. The rabbit 21­ day dermal studies did not show as consistent cholinesterase inhibition with time as other studies showed, although the 3­ day dermal rat study showed a time dependence between day 2 and day 4. The results were somewhat dependent on whether concurrent controls were used or the values for the individual animals at the beginning of the study were used for comparison. Cholinesterase inhibition occurred at the LOAEL in rats, mice, rabbits and dogs. Therefore the effects are very uniform across species. The female of the species appears to be more sensitive than the male and the cholinesterase inhibition occurs at slightly different dose levels across the species. The cholinesterase inhibition appears to be slightly greater in the female than the male in most studies. Adequate developmental toxicity and reproductive toxicity studies show adult toxicity occurs at lower dose levels than toxicity to the fetus or offspring. There is no evidence to support increased susceptibility following pre natal exposure to rat or rabbit fetuses or pre/ post natal exposure to rats. In these studies, toxicity to the fetus or pups occurred only at higher dose levels than to the adults ( dams or parents) . Thus, there is no evidence of increased susceptibility to the fetus or to offspring. The following literature summary is provided to develop a comprehensive picture of disulfoton toxicity. The data have not been reviewed in depth, and no statement is made regarding the accuracy or quality of the data or reports. In a 1988 study by McDonald et al. , disulfoton was administered by daily i. p. injection at 2 mg/ kg/ day to male Long­ Evans rats for 14 days. In treated rats, muscarinic receptor binding was decreased and spacial memory was decreased in a T­ maze alternation task. These effects occurred in the presence of ­ 75% brain ChEI therefore the effects may not be relevant at the NOAEL for brain ChEI. 8. ACUTE TOXICITY ENDPOINTS : Acute Toxicity of disulfoton, technical Guideline No. Study Type MRID # ( S) . Results Toxicity Category 81­ 1 Acute Oral Acc# 072293 LD50 = M: 6.2 mg/ kg; F: 1.9 mg/ kg I 81­ 2 Acute Dermal Acc# 07793 LD50 = M: 15.9 mg/ kg; F: 3.6 mg/ kg I 81­ 3 Acute Inhalation Acc# 258569 LC50 = M: 0.06 mg/ L; F: 0.89 mg/ L I 81­ 4 Primary Eye Irritation None Data requirement waived. N/ A 81­ 5 Primary Skin Irritation None Data requirement waived. N/ A 81­ 6 Dermal Sensitization None Data requirement waived. N/ A 81­ 7 Acute Delayed Neurotoxicity 00129384 Equivocal 81­ 8 Acute Neurotoxicity 42755801 Reversible neurotoxic signs consistent with the cholinesterase inhibition 1.5 mg/ kg in females and 5.0 mg/ kg in males N/ A 9. SUMMARY OF TOXICOLOGY ENDPOINTS The doses and toxicological endpoints selected for various exposure scenarios are summarized in the table below. EXPOSURE SCENARIO DOSE ( mg/ kg/ day) ENDPOINT STUDY Acute Dietary NOAEL = 025 Plasma and RBC cholinesterase inhibition and clinical signs of toxicity. Acute Neurotoxicity­ Rat UF= 100 Acute RfD = 0.0025 mg/ kg Chronic Dietary NOAEL = 0.013 Plasma, RBC, brain and ocular cholinesterase inhibition Chronic Toxicity­ Dog UF= 100 Chronic RfD = 0.00013 mg/ kg/ day Dermal, Short­ Term Dermal NOAEL = 0.5 Plasma and brain cholinesterase inhibition 3­ Dermal Toxicity­ Rat Dermal, Intermediate­ Term Oral NOAEL= 0.03 a Plasma, RBC and brain cholinesterase inhibition 6­ Month Cholinesterase­ Rat Dermal, Long­ Term Oral NOAEL= 0.013 a Plasma, RBC, brain and ocular cholinesterase inhibition Chronic Toxicity­ Dog Inhalation, Short, Intermediate and Long­ Term Inhalation NOAEL= 0.00016 mg/ L or 0.045 mg/ kg/ day Plasma, RBC and brain cholinesterase inhibition 90­ Day Inhalation Toxicity­ Rat a Use 36% dermal absorption factor for route­ to­ route extrapolation.

epa

2024-06-07T20:31:41.571092

regulations

EPA-HQ-OPP-2002-0055-0003

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES June 6, 2001 Memorandum SUBJECT: Review of Determination of Dermal ( Hand and Forearm) and Inhalation Exposure to Disulfoton Resulting from Residential Application of Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care to Shrubs and Flower Beds . MRID No. 453334­ 01. DP Barcode: 273144. FROM: Shanna Recore, Industrial Hygienist Reregistration Branch 2 Health Effects Division ( 7509C) THRU: Al Nielsen, Branch Senior Scientist Reregistration Branch 2 Health Effects Division ( 7509C) TO: Christina Scheltema, Chemical Review Manager Reregistration Branch 3 Special Review and Reregistration Division ( 7508W) Attached is a review of the dermal and inhalation exposure data submitted by Bayer Corporation. This review was completed by Versar, Inc. on March 20, 2001, under supervision of HED. It has undergone secondary review in HED and has been revised to reflect Agency policies. 1 Executive Summary The data collected, reflecting the residential applicator dermal and inhalation exposure of disulfoton, meets most of the criteria specified by the U. S. Environmental Protection Agency s ( US­ EPA) OPPTS Series 875, Occupational and Residential Exposure Test Guidelines, Group A: Application Exposure Monitoring Test Guidelines, 875.1300, Inhalation Exposure ­ ­ Outdoor and 875.1100, Dermal Exposure ­ ­ Outdoor. used to determine dermal and inhalation exposure pending clarification/ response to our outstanding concerns. The data are of sufficient scientific quality to be Summary The purpose of this study was to quantify potential dermal ( forearm and hand) and inhalation exposure for residential applicators of Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care ® , a granular formulation, which contains 1.04 percent disulfoton as the active ingredient. Disulfoton is a systemic organophosphate insecticide registered for use on residential ornamentals including rosebushes, shrubs, and flowerbeds. The maximum application rate for flower beds ( 4 ounces formulated product per 12 square feet) and for shrubs, which includes rosebushes, ( 4 ounces formulated product per 1 foot shrub height) was used in this study. The field study was conducted at the Bayer Corporation Research Farm, Vero Beach, Florida. A total of 15 volunteers were monitored using passive dosimetry ( hand/ forearm wash solutions and personal air monitors) . Application of the product was made by pouring the granules into the measuring cup/ lid attached to the product package, and then distributing the granules onto the soil around the base of a shrub or onto a flower bed. The granules were then soil­ incorporated with a garden rake. Each volunteer applied granular disulfoton around shrubs while wearing gloves and then again without gloves. A total of 60 ( i. e. , 15 volunteers x 4 exposure scenarios) replicates were monitored. Only exposure data from the 30 replicates who did not wear gloves were reported. The test site was a fallow test field, approximately 1 acre in size. Two sets of sub­ plots were established: ( 1) shrub test­ plots, each containing 10 oleander shrubs ( approximately 48 inches high) ; and ( 2) flower­ bed sub­ plots, each containing simulated plants, ( e. g. , 12 to 14 inch high stakes placed on approximately 24 inch centers) . Each volunteer applied approximately 10 pounds of formulated product per application. Shrubs were treated by spreading 16 ounces of granules ( i. e. , 4 ounces per 1 foot of shrub) in a circle around each shrub s base. The granules were then incorporated into the top 1­ 2 inches of soil using a new garden rake. Flower beds were treated by sprinkling 4 ounces of granules to each 12 square feet of a total 480 square feet area, and incorporating the product into the top 1­ 2 inches of soil using a new garden rake. All of the inhalation exposure data were either non­ detect or less than the limit of quantitation ( LOQ) . Most of the hand/ forearm dermal washing samples returned results greater than the LOQ. Disulfoton residues found on the hand and forearm samples collected from monitoring periods where volunteers did not wear gloves were highest when applying Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care ® to shrubs. . All of the samples collected while subjects treated oleander shrubs were positive, with residue levels ranging from 1.39 to 36 µ g/ sample ( N= 15) and with a mean value of 13.5 µ g. Ten of 15 samples collected 2 while subjects treated flowerbeds had results > LOQ, ranging from 1.88 to 20.6 µ g/ sample with a mean of 5.45 µ g. The author speculates applying and working around the larger plants in the shrub plots, and possibly opening and closing the product container at each shrub increased the hand and forearm exposure as compared to flower bed applications. The author reported that the time it took to treat shrubs ranged between 18 and 29 minutes. The time that it took to treat flowerbeds ranged between 20 and 40 minutes. Conclusion The dermal and inhalation exposure study completed in support of the regulatory requirements contained the following omissions and flaws with respect to Series 875 Group A Application Exposure Monitoring Test Guidelines. The most important discrepancies and issues of concern include: ( 1) the Agency is particularly concerned with the sleeve length worn by the study participants ( i. e. long sleeves vs. short sleeves) ; however, the clothing worn by each study participant was not thoroughly described, the author stated only that for the first three sessions, volunteers wore new pairs of Tyvek ® pants over their clothes and described participants clothing as fresh set of clothes and street clothes; ( ( 2) the investigator did not test for breakthrough and it was not ensured that collected material was not lost from the medium during sampling; and ( 3) calibration data for air sampling pumps was not provided and it is not indicated whether the air flow changed and the mean flow was used for all calculations. The following additional items of concern have been noted: The field fortification samples were prepared using liquid disulfoton. Although it is difficult to prepare granular field spikes, there is no known way to compare the recovery results to recoveries of a granular formulation. The significance of this difference is therefore unknown. EPA provided the registrant with comments on study outlines submitted to the Agency. The following comment was not fully addressed in the conduct of the study, as both real plants and simulated plants were used: Use of Simulated Plants: The Agency prefers that the study use real plants because it is difficult, if not impossible, to tell how closely the simulated plant environment reflects what is actually encountered by a homeowner. If the registrant could not find a study site with enough roses or shrubs to treat, the Agency recommended that the study at least include a subset of real plants in established beds to compare the real and the simulated plants. . The Agency requests a response from the registrant on the above mentioned outstanding issues. However, the data collected in this study are of interim sufficient scientific quality and HED will use the results in the RED. Final acceptability of the study will be determined pending the registrant s response to our concerns. 3 inc. MEMORANDUM TO: Christina Jarvis cc: 000.001­ 01 File Margarita Collantes FROM: Diane Forrest/ Susan Anderson Al Nielsen Linda Phillips DATE: March 20, 2001 SUBJECT: Review of Determination of Dermal ( Hand and Forearm) and Inhalation Exposure to Disulfoton Resulting from Residential Application of Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care to Shrubs and Flower Beds, MRID No. 453334­ 01 This report reviews an applicator exposure study , Determination of Dermal ( Hand and Forearm) and Inhalation Exposure to Disulfoton Resulting from Residential Application of Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care to Shrubs and Flower Beds , submitted by Bayer Corporation. A summary of the study and its general accordance with the U. S. EPA Series 875 Guidelines is provided. The following information may be used to identify the study: Title: Determination of Dermal ( Hand and Forearm) and Inhalation Exposure to Disulfoton Resulting from Residential Application of Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care to Shrubs and Flower Beds , 178 pages Sponsor: Wayne Carlson, VP Regulatory Affairs and Product Safety Bayer Corporation 8400 Hawthorne Road Kansas City, MO 64120 Testing Facility: D. Larry Merricks Agrisearch Inc. 5734 Industry Lane Frederick, MD 21704­ 7293 Analytical Laboratory: Michael Williams Horizon Laboratories 1610 Business Loop, 70 West Columbia, MO 65205­ 3608 Author: D. Larry Merricks Report Date: February 8, 2001 Identifying Codes: MRID # 453334­ 01, Agrisearch or Lab. Project ID: 4201; Report No. 110136 4 EXECUTIVE SUMMARY The purpose of this study was to quantify potential dermal ( forearm and hand) and inhalation exposure for residential applicators of Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care ® , a granular formulation, which contains 1.04 percent disulfoton as the active ingredient. Disulfoton is a systemic organophosphate insecticide registered for use on agricultural crops ( e. g. , cereals, potatoes, tobacco, cotton, vegetables) and ornamentals. The maximum application rate for flower beds ( 4 ounces formulated product per 12 square feet) and for shrubs ( 4 ounces formulated product per 1 foot shrub height) was used in this study. The field study was conducted at the Bayer Corporation Research Farm, Vero Beach, Florida. A total of 15 volunteers were monitored using passive dosimetry ( hand/ forearm wash solutions and personal air monitors) . Application of the product was made by pouring the granules into the measuring cup/ lid attached to the product package, and then distributing the granules onto the soil around the base of a shrub or onto a flower bed. The granules were then soil­ incorporated with a garden rake. Each volunteer applied granular disulfoton around shrubs while wearing gloves and then again without gloves. A total of 60 ( i. e. , 15 volunteers x 4 exposure scenarios) replicates were monitored. Only exposure data from the 30 replicates who did not wear gloves were reported. The test site was a fallow test field, approximately 1 acre in size. Two sets of sub­ plots were established: ( 1) shrub test­ plots, each containing 10 oleander shrubs ( approximately 48 inches high) ; and ( 2) flower­ bed sub­ plots, each containing simulated plants, ( e. g. , 12 to 14 inch high stakes placed on approximately 24 inch centers) . Each volunteer applied approximately 10 pounds of formulated product per application. Shrubs were treated by spreading 16 ounces of granules ( i. e. , 4 ounces per 1 foot of shrub) in a circle around each shrub s base. The granules were then incorporated into the top 1­ 2 inches of soil using a new garden rake. Flower beds were treated by sprinkling 4 ounces of granules to each 12 square feet of a total 480 square feet area, and incorporating the product into the top 1­ 2 inches of soil using a new garden rake. All of the inhalation exposure data were either non­ detect or less than the LOQ. Most of the hand/ forearm dermal washing samples returned results greater than the LOQ. Disulfoton residues found on the hand and forearm samples collected from monitoring periods where volunteers did not wear gloves were highest when applying Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care ® to shrubs. . All of the samples collected while subjects treated oleander shrubs were positive, with residue levels ranging from 1.39 to 36 µ g/ sample ( N= 15) and with a mean value of 13.5 µ g. Ten of 15 samples collected while subjects treated flowerbeds had results > LOQ, ranging from 1.88 to 20.6 µ g/ sample with a mean of 5.45 µ g. The author speculates applying and working around the larger plants in the shrub plots, and possibly opening and closing the product container at each shrub increased the hand and forearm exposure as compared to flower bed applications. The author reported that the time it took to treat shrubs ranged between 18 and 29 minutes. The time that it took to treat flowerbeds ranged between 20 and 40 minutes. Five of these exposure periods exceeded the maximum 29 minutes it took to treat a shrub sub­ plot. The study was conducted in compliance with the major technical aspects of OPPTS Group A: 875.1300, Inhalation Exposure ­ ­ Outdoor and 875.1100, Dermal Exposure ­ ­ Outdoor, and Series 875 Group B, Part C, as they relate to this study. Reviewers noted the following issues of potential interest in interpreting the results: C EPA provided the registrant with comments on study outlines submitted to the Agency. The following comment was not addressed in the conduct of the study: Use of Simulated Plants: The Agency prefers that the study use real plants because it is 5 difficult, if not impossible, to tell how closely the simulated plant environment reflects what is actually encountered by a homeowner. If the registrant could not find a study site with enough roses or shrubs to treat, the Agency recommended that the study at least include a subset of real plants in established beds to compare the real and the simulated plants. . C For the first three days of exposure monitoring, wind speeds ranged between 4.2 and 8.9 mph. Therefore, conditions were generally windy. C The test sites were irrigated once the evening prior to each day s exposure monitoring, and again during the lunch break on the first day of exposure monitoring. Sprinkler irrigation was used, and 0.5 inches of water was applied to maintain a packed surface and minimize dust cross­ contamination. This is not considered appropriate for a handler exposure study because it may have decreased handler pesticide exposure and may not be representative of typical residential handler behavior. C There were a total of 60 samples collected for inhalation exposure, and 60 samples collected for dermal exposure, reflecting 15 volunteer subjects, applying disulfoton to both shrubs and flowers bed test plots, with and without gloves. Only the 30 samples, for the inhalation exposure, and 30 samples, for the dermal exposure, representing the no glove scenario were reported. . All data should have been reported, especially the inhalation exposure samples, which would not have been affected by the use of gloves. 6 STUDY REVIEW Study Background The purpose of this study was to quantify potential dermal ( forearm and hand only) and inhalation exposure for residential applicators of Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care ® , a granular formulation, containing 1.04 percent disulfoton as the active ingredient. The CAS name for disulfoton is O, O­ diethyl­ S­ [ 2­ ethylthio) ethyl ] ­ phosphorodithioate, and the CAS No. is # 298­ 04­ 4. Disulfoton is a systemic organophosphate insecticide registered for use in agricultural crops ( e. g. , cereals, potatoes, tobacco, cotton, vegetables) and ornamentals. Exposure monitoring took place on four days: October 23, 24, 25, and 26, 2000. Sample analyses were complete by December 16, 2000. Attestations The study sponsor waived claims of confidentiality within the scope of FIFRA Section 10 ( d) ( 1) ( A) , ( B) , or ( C) . The study sponsor and author attested that the study was conducted according to current EPA FIFRA Good Laboratory Practice Standards ( 40 CFR Part 160) . There was one notation to the effect that a pocket penetrometer ( used to gauge the degree of soil compaction in the test plots) could not be calibrated. A Quality Assurance Statement was included covering: test procedures, raw and final data review, draft and final report. Test Plots The field study was conducted at the Bayer Corp. Research Farm, Vero Beach, Florida. The test site a one acre fallow test field, was disked and prepared in early September 2000. The exact soil type was not reported, but the soil was reported to be sandy. Two sets of sub­ plots were established, one planted with oleander shrubs and the other containing simulated plants. There were 32 shrub test­ plots, each measuring 3 feet by 39 feet, and each containing 10 oleander shrubs which were approximately 48 inches high. The shrubs had been planted approximately 33 days prior to exposure monitoring. Each shrub test plot was separated from the next test plot by at least 4 feet to minimize cross contamination. Likewise, there were 32 flower beds, each measuring 480 square feet ( 4 feet by 120 feet) . Each sub­ plot contained simulated plants, that is, 12 to 14 inch high stakes placed on approximately 24 inch centers. The beds were not cultivated for 30 days prior to the exposure monitoring. The flower beds had enough separation between beds to minimize cross contamination. A pocket penetrometer was used to collect soil compaction measurements. The soil was relatively uniform throughout; the compaction ranged between 0.75 and 1.25 tons / square foot. Replicates This study collected hand and forearm dermal exposure data and inhalation exposure data from volunteers applying granular disulfoton around shrubs, and to flower beds. The product was applied by pouring the granules into a measuring cup/ lid, sprinkling onto the soil, and soil­ incorporating with a garden rake. There were 15 volunteer subjects, each monitored for 4 exposure periods. Sampling included 30 replicates collected during gloved hand application, and 30 replicates collected during applications made without the use of protective gloves. Only exposure data from the 30 replicates who did not wear gloves were reported. 7 Volunteers ranged in age from 20 to 73 years old, had 0 to 40 years experience gardening, and worked from 18 minutes to 50 minutes during each application. There were nine female and six male applicators. Information on each individual volunteer such as height, weight, age, sex, and years experience using residential pesticide products may be found on page 16 of the Study Report. Work Activities Each of the 15 volunteers was monitored for both inhalation and hand/ forearm dermal exposure at 4 sampling times on the same day ( total number of replicates = 60) . Each of the 2 use pattern applications ( rose bushes/ shrubs and flower beds) was conducted by volunteers wearing gloves. Then the same use pattern applications were conducted by the same volunteers without gloves. Four volunteers were monitored on each of the first three days, followed by the monitoring of three volunteers on the fourth day. Prior to each exposure period, volunteers washed their hands and arms with soap and water. Volunteers were asked to wear a fresh set of clothes to minimize possible contamination. For the first three sessions, volunteers wore new pairs of Tyvek ® pants over their clothes. . Due to heat, some of the volunteers did not wear Tyvek ® trousers on their fourth application, since their street clothes had been protected during the three prior exposure periods. Only exposure data from the 30 replicates who did not wear gloves were reported. Essentially, each volunteer carried an unopened 10 pound container of 1 percent disulfoton granules to the application location. The measuring cap/ lid was removed, and the desired amount poured into the cap. Shrubs were treated by spreading 16 ounces of granules ( i. e. , 4 ounces per 1 foot of shrub) in a circle around each shrub s base. The granules were then incorporated into the top 1­ 2 inches of soil using a new garden rake. The applicator then carried the product container to the next shrub and repeated the procedure ( pouring, sprinkling, incorporating) . After all 10 shrubs were treated the applicator replaced the measuring cap onto the container, tightened the cap and returned to the staging area for the hand/ forearm wash procedure. Flower beds were treated by sprinkling 4 ounces of granules to each 12 square feet of the flower bed, and repeating the pouring and sprinkling steps until the whole 480 square feet of area was covered. Then the applicators incorporated the granules into the top 1­ 2 inches of soil using a new garden rake. Finally, each volunteer replaced the measuring cap and returned to the staging area with their closed, empty ( or nearly empty) containers. The amount applied was estimated by weighing each container before and after application. Each volunteer applied approximately 10.1 pounds of formulated product per application, or about 40.4 pounds overall for each day. The study author included a table briefly noting observations made of each worker during each disulfoton granule application ( see page 19 of the Study Report) . Some volunteers worked upwind while applying or cultivating the product and did not enter the test plot bedding area, and some worked downwind while applying or cultivating the product or worked in the test plot bedding area. Overall, volunteers were observed working in the test plot beds more when working with the shrubs than during the flower bed applications since they worked around larger plants as opposed to simulated plants. Some volunteers walked in treated beds to rake, at least one volunteer rubbed their eye with their hands. Some volunteers were observed wiping sweat from their face with their forearms. In general, the author stated that it took about 20 percent more time to apply and incorporate disulfoton granules into flower­ bed soil. Meteorology and Irrigation The test sites were irrigated once the evening prior to each day s exposure monitoring, and again during the lunch break on the first day of exposure monitoring ( October 23, 2000) . Sprinkler irrigation was used, and 0.5 inches of water was applied to maintain a packed surface and minimize dust cross­ contamination. An onsite weather station was set up at the test site, and recorded hourly average ( collected at 1­ minute intervals) ambient air temperature, relative humidity, wind speed and wind direction on each 8 application day. In general, meteorological monitoring was conducted between approximately 8 AM and 4 PM ( ending times each day were different) . Ambient air temperatures ranged between 69.6 E F and 83.3 E F, relative humidity ranged between 51.9 and 92.9 percent, and wind speeds ranged between 1.3 mph and 8.9 mph. For the first three days of exposure monitoring, wind speeds ranged between 4.2 and 8.9 mph. Therefore, conditions were generally windy. No historical weather data were provided for review. Pesticide Use History Paraquat was applied once to the flower bed plots and Roundup ® was applied as needed to both plots, prior to the exposure monitoring dates, to control unwanted vegetation. No other pesticide use history information was provided. Materials and Application Method The product used in the study was EPA Reg. No. 3125­ 517, containing 10 pounds granular product, packaged as a plastic container with a measuring cup/ lid. The product contains approximately 1 percent disulfoton active ingredient. The maximum application rate for flower beds ( 4 ounces formulated product per 12 square feet) and for shrubs ( 4 ounces formulated product per 1 foot shrub height) was used in this study. Application was made by pouring the product into the measuring cap/ lid and then sprinkling around shrubs or on flower­ bed test plots, followed by soil incorporation using a garden rake. Sample Collection Personal air monitoring samples and hand/ forearm wash samples were collected in this study. 1. Inhalation Exposure Samples Personal air samples were collected from each volunteer using OVS tubes containing two sections ( 140 mg/ 270 mg) of XAD­ 2 resin, connected via plastic tubing to Gilian ® air sampling pumps calibrated to an approximate flow rate of 2. 0 liters/ minute. Pump on­ and off­ times were recorded. There were a total of 60 breathing zone samples collected, reflecting 15 volunteer subjects, applying disulfoton to both shrub and flower bed test plots, with and without gloves. Again, data for only 30 of the 60 samples were reported. 2. Dermal Exposure Samples Exposure to the hands and forearms was determined by detergent washed hand and foreaarm solutions collected at the staging area. One 500 mL aliquot of an aqueous solution of anionic surfactant ( i. e. sodium dioctyl sulfosuccinate ( OTS) ­ 0.01 percent w/ v in distilled water) was used to wash subjects hands and forearms. As reported by the author: The volunteer placed his hands and forearms in and over a metal container while an investigator slowly poured the aliquot of OTS over them ensuring complete contact of all skin surfaces. At the end of sixty seconds of the volunteer scrubbing his/ her hands and forearms in the OTS, the solution was carefully poured into a labeled glass jar. There were a total of 60 dermal exposure samples collected, reflecting 15 volunteer subjects, applying disulfoton to both shrub and flower bed test plots, with and without gloves. Data for only 30 of the 60 samples collected overall were reported ( i. e. , the no glove scenarios) . 9 QA/ QC Sample Handling & Storage Each jar of OTS skin washing solution was capped with a Teflon ® ­ ­ lined lid, heat sealed in a plastic bag, and stored in freezer conditions until shipment to the laboratory. Each OVS sample was capped in the field at both ends, labeled, placed in a reclosable plastic bag, and placed into freezer storage until shipment to the laboratory. Field freezers ranged in temperature between ( ­ ) 25.8 E C and ( ­ ) 12.2 E C. Samples were packed with shock insulators and shipped frozen on dry ice. Air samples were sent on October 26, 2000, the final sampling day. All samples received by the analytical laboratory were stored in freezers at temperatures ranging between ( ­ ) 26 E C and ( ­ ) 10 E C. Sample History A sample history table was not provided. Exposure monitoring took place on four days: October 23, 24, 25, and 26, 2000. The field OVS air samples were received at the analytical laboratory on October 27, 2000. Field dermal wash samples were received at the analytical laboratory on November 7, 2000. Raw data sheets attached to the analytical report included some sample tracking information. Product Analyses Each lot of test substance was analyzed for purity and the percentage of active ingredient was verified. The Certificate of Analysis was provided as an attachment to the Study Report. Analytical Methodology It appears that a proprietary method was used. A copy of the method was not included in the study report. 1. OVS Air Sampling Tubes Tube contents were analyzed as a single sample. Disulfoton was desorbed from the tube contents with acetone. The acetone extract was filtered, diluted to an appropriate volume in acetone, and residues quantified via GC/ FPD( P) . 2. OTS Dermal Washing Samples Dermal washing samples were thawed, mixed with an equal volume of methanol ( 500 mLs) , and aliquots were cleaned up on a conditioned C­ 18 SPE column. The analyte was eluted from the column with acetone. Disulfoton residues were quantified via GC/ FPD( P) . Chromatographic conditions are listed on page 80 of the Study Report. The method employed a DB­ 5MS column ( 30M x 0.25 mm, 0.25 µ M film thickness) . Retention time for disulfoton was about 6.7 minutes. Calibration standards were run with each set, at levels ranging between 5 ng/ mL and 250 ng/ mL. Data were collected using the Chrom Perfect for Windows ® ( ( CPWIN) data acquisition system. Data were imported into Quattro Pro ® spreadsheets and calculations were performed using Horizon s LINCURV4 ® calculation program, which prepares standard curves of response vs. ng/ mL using least squares regression. This system was validated on each computer with a model data set prior to each day s run. 10 Limits of Detection ( LOD) & Limits of Quantitation ( LOQ) The LOD was not defined. The reported LOQs were 0.3 µ g/ air sampling tube, and 1.5 µ g/ dermal wash sample. The basis for the determination of LOQ was not reported. Concurrent Laboratory Recovery Field samples were analyzed in sets containing from 12 to 20 samples each. Laboratory controls were included in each set. These fortified controls were fortified at 4 levels as follows: untreated, LOQ, 10X LOQ and 100X LOQ. A summary of the results is presented on page 92 of the Study Report. The overall mean percent recovery of concurrent laboratory fortifications from OVS air sampling tubes was 99.9 ± 6.42 percent ( N= 15) . The overall mean percent recovery from hand/ forearm wash solution was 99. 5 ± 9.15 percent ( N= 24) . Five out of the 8 untreated control air sampling tube samples contained apparent disulfoton residues greater than zero. The residues were less than 10 percent of the LOQ, and the authors state that this residue had a negligible effect on recoveries at any level. Laboratory recovery samples, but not field fortification samples, were corrected for residues found in the companion untreated control samples. No residue in any field sample was corrected for laboratory fortification recoveries. No disulfoton residues were detected in any of the untreated hand/ forearm wash control solutions. Field Fortification Recovery Fortified disulfoton solutions and pre­ fortified sorbent OVS tubes were prepared by Horizon Laboratories, and then shipped on dry ice overnight to the field facility, where they were also kept frozen. Field­ fortified controls were prepared once each day of exposure monitoring ( i. e. , four times) . They were prepared at the test site staging area, near to the test sites, but away from possible contamination. Specifically, a vial of fortification solution was uncapped and the entire vial ( contents plus container) was dropped into a 500 mL aliquot of OTS solution. Pre­ fortified OVS air sampling tubes were brought to ambient temperature in the field, connected to a multiport pump and manifold system and the pump was run for the approximate length of a replicate exposure period at 2.0 liters per minute. Five replicates of each exposure matrix were fortified on each of the four monitoring days, at three fortification levels. For dermal wash samples, the fortification levels were 1.5, 15, and 150 µ g/ sample, and for the air samples the fortification levels were 0.3, 3 and 30 µ g/ sample. The field fortification samples were packaged, stored, and shipped under the same environmental conditions as the field samples. For air samples, the overall average fortified field recovery was 98.2 ± 6.32 percent ( N= 62) with no apparent differences in mean recoveries between days or fortification levels. Table 1 summarizes field recoveries by fortification level. No measurable disulfoton was measured in any field fortification untreated control sample except for one sample which had a reading of 0.022 F g ( < LOQ) . For hand/ forearm wash samples collected from volunteers who did not wear gloves, 5 of 30 samples were less than LOQ. The highest level of disulfoton found in any sample was 36 µ g/ sample. Therefore, the fortification levels analyzed covered the full range of field sample levels. Overall field fortified recovery for these samples was 99.4 ± 7.95 percent ( ( N= 36) with no apparent differences in recovery values between days. As noted by the author, there was a slight trend towards increased mean recovery values as the disulfoton 11 concentration increased, however, all recovery values were well within guideline specifications ( i. e. , 70 to 120 percent) . Table 1 presents a summary of field fortifications recoveries by fortification level. No measurable disulfoton residue was measured in any field fortification untreated control hand wash sample. Table 1. Summary of Field Fortification Recoveries Sample Fortification Level Average Recovery ( Percent) Day 1 Day 2 Day 3 Day 4 Air Sampling Tubes 0.3 F g 95.7 ± 5.26 ( N = 5) 96.0 ± 4.38 ( N = 3) 97.2 ± 4.54 ( N = 3) 98.4 ± 2.86 ( N = 3) 3.0 F g 105 ± 2.60 ( N = 5) 103 ± 3.45 ( N = 3) 103 ± 2.48 ( N = 3) 99.9 ± 0.500 ( N = 3) 30 F g 94.0 ± 11.4 ( N = 5) 91.8 ± 7.42 ( N = 3) 102 ± 2.13 ( N = 3) 93.5 ± 2.88 ( N = 3) Dermal Wash Solution 1.5 F g 92.1 ± 5.65 ( N = 3) 96.8 ± 2.75 ( N = 3) 91.8 ± 5.14 ( N = 3) 92.0 ± 3.69 ( N = 3) 15 F g 104 ± 2.92 ( N = 3) 104 ± 4.70 ( N = 3) 94.3 ± 16.1 ( N = 3) 97.7 ± 9.96 ( N ­ 3) 150 F g 107 ± 0.907 ( N = 3) 108 ± 1.75 ( N = 3) 101 ± 4.09 ( N = 3) 105 ± 2.90 ( N = 3) Storage Stability Recovery No storage stability samples were prepared. Instead, the authors relied on field recovery samples, which were handled and analyzed in conjunction with the field test samples. Results Tables 2 and 3 summarize the exposure monitoring results by replicate for application to shrubs and flower beds, respectively. All of the inhalation exposure data were either non­ detect or less than the LOQ. Possible reasons for these finding include: 1) disulfoton is not volatile, and the formulation used was granular; 2) samples were collected on sorbent tubes; 3) the exposure periods were very brief, ranging between 18 and 38 minutes; and 4) samples were collected outdoors under rather windy conditions and small air volumes were collected, ranging between 36 and 76 liters per sample. 12 Table 2. Summary of Exposure Data By Replicate ­ Shrub Application Volunteer Body Weight ( kg) Formulation Applied ( lb ai) rounded Hours Worked Air Volume ( Liters) Inhalation Exposure ( F g/ sample) Hand/ Forear m Exposure ( F g/ sample) 1 68 0. 1 0.35 42 ND 13.40 2 66 0. 1 0.30 36 < LOQ 30.20 3 114 0.1 0. 32 38 < LOQ 18.70 4 64 0. 1 0.38 46 < LOQ 15.00 5 66 0. 1 0.45 54 ND 3.53 6 73 0. 1 0.40 48 ND 17.20 7 57 0. 1 0.45 54 < LOQ 4.51 8 55 0. 1 0.38 46 < LOQ 1.63 9 59 0. 1 0.38 46 ND 9.46 10 70 0.1 0. 37 44 ND 36.00 11 80 0.1 0. 35 42 < LOQ 4. 11 12 132 0.1 0. 35 42 ND 24.50 13 66 0.1 0. 40 48 < LOQ 1. 39 14 102 0.1 0. 48 58 ND 6. 99 15 77 0.1 0. 37 44 ND 16.10 Arithmetic Mean ­ ­ ­ ­ ­ 12.9 Standard Deviation ­ ­ ­ ­ ­ 10.0 Coefficient of Variance ­ ­ ­ ­ ­ 78 percent LOQ = 0.3 F g/ air sampling tube ( ½ LOQ or 0.15 F g was assigned to values < LOQ or ND) 13 Table 3. Summary of Exposure Data By Replicate ­ Flower Bed Application Volunteer Body Formulation Hours Air Volume Inhalation Hand/ Forear Weight ( kg) Applied ( lb ai) ( rounded) Worked ( Liters) Exposure ( F g/ sample) m Exposure ( F g/ sample) 1 68 0. 1 0.37 44 < LOQ < LOQ 2 66 0. 1 0.42 50 < LOQ 2.94 3 114 0.1 0. 33 40 < LOQ 1. 88 4 64 0. 1 0.37 44 < LOQ 20.60 5 66 0. 1 0.63 76 < LOQ 8.45 6 73 0. 1 0.57 68 < LOQ < LOQ 7 57 0. 1 0.53 64 < LOQ < LOQ 8 55 0. 1 0.67 80 < LOQ < LOQ 9 59 0. 1 0.47 56 < LOQ 4.24 10 70 0.1 0. 40 48 < LOQ 5. 00 11 80 0.1 0. 42 50 < LOQ 12.10 12 132 0.1 0. 43 52 < LOQ 3. 16 13 66 0.1 0. 45 54 < LOQ 11.90 14 102 0.1 0. 52 62 < LOQ < LOQ 15 77 0.1 0. 45 54 < LOQ 8. 20 Arithmetic Mean ­ ­ ­ ­ 0.15 5.4 Standard Deviation ­ ­ ­ ­ ­ 5.8 Coefficient of Variance ­ ­ ­ ­ ­ 106 percent LOQ = 0.3 F g/ air sampling tubes ( ½ LOQ or 0.15 F g was assigned to values < LOQ) LOQ = 1.5 F g/ dermal wash ( ½ LOQ or 0.75 F g was assigned to values < LOQ for calculation of mean) Most of the hand/ forearm dermal washing samples returned residue levels greater than the LOQ. All of the samples collected while subjects treated oleander shrubs were positive, ranging from 1. 39 to 36 µ g/ sample ( N= 15) . Ten of 15 samples collected while subjects treated flowerbeds were positive. For those 10 positive samples, values ranged between 1.88 to 20.6 µ g/ sample. The author reported that the time it took to treat shrubs ranged between 18 and 29 minutes. The time that it took to treat flowerbeds ranged between 20 and 40 minutes; five of these exposure periods exceeded the maximum 29 minutes it took to treat a shrub sub­ plot. Tables 4 and 5 present the exposure data in unit exposure values, normalized to pounds active ingredient per amount handled per sampling period, and pounds active ingredient per amount handled per hour, and pounds active ingredient per amount handled per kilogram body weight per sampling period. These values were calculated by Versar. An inhalation unit exposure volume was not determined for shrub plot applications because no numerical value was assigned in the report to non­ detect values. In the risk assessment accompanying the Study Report ( MRID 453334­ 02) the registrant using a value of 30 percent of the LOQ ( 0.09 F g) for non­ detects. 14 Table 4. Unit Exposure Values ­ Shrubs Type mg/ lb ai mg/ hour e mg/ kg/ sampling period f Dermal a, d Inhalation b, c Dermal a Inhalation b Dermal a Inhalation b Arithmetic Mean 0.14 0.013 0.038 0.0004 0.0002 0.0000055 Std. Dev. 0.11 0.000079 0.032 0.00005 0.00018 0.0000013 Geo Mean 0.092 0.013 0.024 0.0004 0.00013 0.0000053 25th % tile 0.043 0.012 0.011 0.00038 0.000061 0.0000051 75th % tile 0.18 0.013 0.051 0.00043 0.00024 0.0000062 90th % tile 0.27 0.013 0.086 0.00045 0.00049 0.0000070 95th % tile 0.32 0.013 0.098 0.00048 0.00053 0.0000073 99th % tile 0.35 0.013 0.10 0.0005 0.00056 0.0000075 LOQ = 0.3 F g/ air sampling tube LOQ = 1.5 F g/ dermal wash A respiratory rate of 16.7 L/ min was assumed, based on the draft NAFTA recommended inhalation rates. a The unit exposure value is base on data where some values are < LOQ b The unit exposure value is based on data where all values are < LOQ. Inhalation unit exposure ( mg/ lb ai) = [ residue ( F g* 0.001) / air volume ( l) ] * 16.7 l/ min( minute volume of human) * minutes worked / pounds ai handled. d residue ( F g* 0.001) / pounds ai handled e residue ( F g* 0.001) / hours worked f residue ( F g* 0.001) / body weight/ hours worked Table 5. Unit Exposure Values ­ Flower Beds Type mg/ lb ai mg/ hour e mg/ kg/ sampling period f Dermal a, d Inhalation b, c Dermal a Inhalation b Dermal a Inhalation b Arithmetic Mean 0.054 0.013 0.013 0.00033 0.000079 0.0000045 Std. Dev. 0.058 0.0000829 0.015 0.000065 0.000087 0.0000011 Geo Mean 0.030 0.013 0.0066 0.00033 0.00044 0.0000044 25th % tile 0.0075 0.012 0.0017 0.00029 0.00015 0.0000038 75th % tile 0.083 0.013 0.016 0.00037 0.00012 0.0000054 90th % tile 0.12 0.013 0.028 0.00041 0.00017 0.0000057 95th % tile 0.15 0.013 0.037 0.00042 0.00022 0.0000061 99th % tile 0.19 0.013 0.052 0.00045 0.0003 0.0000063 LOQ = 0.3 F g/ air sampling tube LOQ = 1.5 F g/ dermal wash A respiratory rate of 16.7 L/ min was assumed, based on the draft NAFTA recommended inhalation rates. a The unit exposure value is base on data where some values are < LOQ b The unit exposure value is based on data where all values are < LOQ. c Inhalation unit exposure ( mg/ lb ai) = [ residue ( F g* 0.001) / air volume ( l) ] * 16.7 l/ min( minute volume of human) * minutes worked / pounds ai handled. d residue ( F g* 0.001) / pounds ai handled e residue ( F g* 0.001) / hours worked f residue ( F g* 0.001) / body weight/ hours worked 15 c Compliance Checklist s Compliance with OPPTS Series 875, Occupational and Residential Exposure Test Guidelines is critical. The itemized checklist below outlines compliance with the major technical aspects of OPPTS Group A: 875.1300, Inhalation Exposure ­ ­ Outdoor and 875.1100, Dermal Exposure ­ ­ Outdoor, as they relate to the study. C Typical end use product of the active ingredient used. This criterion was met. C End use product handled and applied using recommended equipment, application rates, and typical work practices. It is uncertain whether this criteria was met. The application technique employed in this study might not represent the typical method of application of granular pesticide to rose bushes or shrubs. It is likely that a homeowner could apply the product while on hands and knees and reaching underneath foliage ( with hands or hand trowel) to reach the base of the plant. If this work practice was assessed, additional dermal monitoring would be required in order to adequately characterize potential dermal exposure ( i. e. , exposure to knees, upper and lower legs, and feet) . C A minimum of five replicates each at a minimum of three different sites are to be employed. This criterion was met. C Dermal and/ or inhalation exposure should be monitored by validated methodologies. This criterion was met. C There should be a minimum of one field­ fortified sample per worker per monitoring period for each fortification level, plus unfortified field blanks . This criterion was met. C The efficiency of extraction of hand rinses conducted in one solvent with subsequent partition into a second solvent for analysis should be determined . This criterion was met. Method validation, laboratory and field­ fortified recovery values were satisfactory. C The stability of the analyte of interest in the medium of interest must be determined . This criterion was met as demonstrated by satisfactory field fortification recoveries. C The following information should be reported for agricultural applications, yards, gardens: ( 1) description of the crop, plot size, row spacing; ( 2) description of application ( including rate, type of formulation, tank capacity, type of carrier, final mix concentration, total pounds active ingredient applied or mixed) ; ( 3) description of application equipment ( type, model) ; ( 4) weather data: relative humidity, wind speed, wind direction, and temperature; ( 5) work activity monitored; ( 6) exposure observations; ( 7) exposure time . These criteria were met. C After collection, field samples should be stored immediately in a freezer pending further treatment. This criterion was met. C A sample history sheet should be included in the report, tracking sample number, date of collection, date of extraction, date of analysis, and identification of who participated in each stage . This criterion was partially met. While a history sheet as such was not provided, most of the information was available in the report. 16 C Clothing worn by each study participant should be thoroughly described. This criterion was not met. The author states that for the first three sessions, volunteers wore new pairs of Tyvek ® pants over their clothes . The other clothing worn by study participants ( e. g. , long sleeved vs. short sleeved shirt) is described only as fresh set of clothes and street clothes . C Quantity of active ingredient handled and duration of monitoring period should be reported for each replication. This criterion was met. C Testing should include at least one field fortification sample per worker per monitoring period per fortification level for each matrix should and at least one field blank per worker per monitoring period for each matrix. This criterion was met. C Efficiency of extraction in laboratory provided as a mean plus or minus one standard deviation. This criterion was met. C The analytical method for inhalation monitoring should be sufficiently sensitive so that, coupled with the trapping and extraction procedures chosen, it is capable of measuring exposure to 1 µ g/ hour ( or less) . This criterion was met. The LOQ for the method was 0.3 µ g/ sample. Samples were collected on OVS­ XAD sorbent tubes. Exposure periods ranged between 18 and 38 minutes, and were collected at 2 liters/ minute, yielding sample volumes, ranging between 36 and 76 liters per sample. C To ensure that collected material is not lost from the medium during sampling, the investigator should also test for breakthrough . This criterion was not met. The investigator did not test for breakthrough to ensure that collected material was not lost. C If trapping media are to be stored after exposure, a test for the storage stability of the compound should be documented. The time periods for storage are to be chosen so that the longest corresponds to the longest projected storage period for field samples . This criterion was met. Field­ fortified recovery samples analyzed at about the same time as the field samples indicated satisfactory storage stability. C Applicator s inhalation exposure should be measured with battery­ powered personal monitoring pumps capable of producing an airflow of at least 2 liters per minute and pump batteries should be capable of sustaining maximum airflow for at least 4 hours without recharging. This criterion was met. C The intake tube of any pump­ powered sampler unit should be positioned so that the opening is downward. The intake tube should be placed as near as possible to the nose level of the test subject . It is not known whether these criteria were met, as these details were not reported. The author did, however, state that monitoring occurred in the breathing zone. C Calibration data for air sampling pumps should be provided. If the air flow has been found to change, the mean flow should be used for all calculations . This criterion was not met. Calibration data for air sampling pumps was not provided. The following additional items of concern have been noted: The field fortification samples were prepared using liquid disulfoton. Although it is difficult to prepare granular field spikes, there is no known way to compare the recovery results to recoveries of a granular formulation. The significance of this difference is therefore unknown. 17 EPA provided the registrant with comments on study outlines submitted to the Agency. The following comment was not fully addressed in the conduct of the study, as both real plants and simulated plants were used: Use of Simulated Plants: The Agency prefers that the study use real plants because it is difficult, if not impossible, to tell how closely the simulated plant environment reflects what is actually encountered by a homeowner. If the registrant could not find a study site with enough roses or shrubs to treat, the Agency recommended that the study at least include a subset of real plants in established beds to compare the real and the simulated plants. . 18

epa

2024-06-07T20:31:41.582524

regulations

EPA-HQ-OPP-2002-0055-0004

Supporting & Related Material

31 May 2001 MEMORANDUM SUBJECT: REVISED RESIDENTIAL EXPOSURE ASSESSMENT AND RECOMMENDATIONS FOR THE REREGISTRATION ELIGIBILITY DECISION DOCUMENT FOR DISULFOTON FROM: Shanna Recore, Industrial Hygienist Christina Jarvis, Environmental Protection Specialist Reregistration Branch 2 Health Effects Division ( 7509C) TO: Christina Scheltema Reregistration Branch 3 Special Review and Reregistration Division ( 7508W) THRU: Al Nielsen, Senior Scientist Reregistration Branch 2 Health Effects Division ( 7509C) Please find attached the residential review of disulfoton. DP Barcode: D275170 Pesticide Chemical Codes: 032501 EPA Reg Nos. : 4­ 153, 4­ 253, 4­ 420, 16­ 171, 192­ 74, 192­ 119, 192­ 126, 192­ 164, 239­ 2134, 769­ 908, 802­ 426, 869­ 76, 869­ 223, 904­ 138, 3125­ 83, 3125­ 116, 3125­ 152, 3125­ 517, 5887­ 67, 5887­ 171, 7401­ 4, 4701­ 26, 7401­ 235, 7401­ 323, 9404­ 3, 8660­ 125, 8660­ 191, 11474­ 17, 32802­ 32, 42057­ 51, 46260­ 2, 46260­ 12, 46260­ 35, 59144­ 23 EPA MRID No. : 453334­ 01 PHED: Yes, Version 1.1 EXPOSURE AND RISK ASSESSMENT/ CHARACTERIZATION Purpose In this document, which is for use in EPA' s development of the disulfoton Reregistration Eligibility Decision document ( RED) , EPA presents the results of its review of the potential human health effects of residential exposure to disulfoton. This memorandum revises the residential exposure section of the February 7, 2000 memorandum titled Revised Occupational and Residential Exposure Assessment and Recommendations for the Reregistration Eligibility Decision Document for Disulfoton. 2 The residential exposure and risk numbers presented in this document have been revised based on a new short­ term dermal endpoint, new exposure assumptions in the Residential Standard Operating Procedures ( SOPs) , and a new disulfoton residential handler study submitted by Bayer Corporation. Criteria for Conducting Exposure Assessments An occupational and/ or residential exposure assessment is required for an active ingredient if ( 1) certain toxicological criteria are triggered and ( 2) there is potential exposure to handlers ( mixers, loaders, applicators, etc. ) during use or to persons entering treated sites after application is complete. For disulfoton, both criteria are met. Summary of Toxicity Concerns Relating to Residential Exposure Acute Toxicology Categories Table 1 presents the acute toxicity categories based on the active ingredient as outlined in the Hazard Identification document. 12 1 Table 1: Acute Toxicity Categories for Disulfoton Guideline No. Study Type MRID # ( S) . Results Toxicity Category 81­ 1 Acute Oral Acc# 072293 LD50 = M: 6. 2 mg/ kg; F: 1. 9 mg/ kg I 81­ 2 Acute Dermal Acc# 07793 LD50 = M: 15. 9 mg/ kg; F: 3. 6 mg/ kg I 81­ 3 Acute Inhalation Acc# 258569 LC50 = M: 0. 06 mg/ L; F: 0. 89 mg/ L I 81­ 4 Primary Eye Irritation None Data requirement waived. N/ A 81­ 5 Primary Skin Irritation None Data requirement waived. N/ A 81­ 6 Dermal Sensitization None Data requirement waived. N/ A 81­ 7 Acute Delayed Neurotoxicity 00129384 Equivocal. 81­ 8 Acute Neurotoxicity 42755801 Reversible neurotoxic signs consistent with the cholinesterase inhibition 1. 5 mg/ kg in female rats and 5. 0 mg/ kg in male rats. N/ A N/ A = Not Applicable Residential Endpoints of Concern The revised Hazard Identification document for disulfoton indicates that there are toxicological endpoints of concern for residential exposure. The endpoints used in assessing the residential risks for disulfoton are presented in the following Table 2. 12 2 Table 2: Endpoints for Assessing Residential Risks for Disulfoton Test Results Short­ term Dermal Exposure ( 1 to 7 days) 0. 5 mg/ kg/ day based on plasma and brain cholinesterase inhibition in a 3­ day dermal study in rats ( Uncertainty Factor = 100) Intermediate­ term Dermal Exposure ( 1 week to several months) 0.03 mg/ kg/ day based on plasma, red blood cell, and brain cholinesterase inhibition in a special 6 month cholinesterase inhibition feeding study in rats ( Uncertainty Factor = 100) * * this study also used for the incidental soil ingestion scenario* * Inhalation Exposure ( All­ time periods) 0. 00016 mg/ L or 0.045 mg/ kg/ day based on plasma, red blood cell, and brain cholinesterase inhibition in a 90­ day inhalation study in rats ( Uncertainty Factor = 100) Dermal Absorption ( applied to intermediate­ term dermal endpoint only) 36% Inhalation Absorption 100% FQPA Safety Factor The FQPA Safety Factor Committee met on January 24, 2000 to re­ evaluate the hazard and exposure data for disulfoton, and recommended that the FQPA safety factor be removed ( 1X) for disulfoton. 10 The toxicity data base is complete, including neurotoxicity studies in rats and there is no evidence of either neurotoxicity or increased susceptibility of fetuses or offspring in prenatal and postnatal studies in rabbits or rats. The 1X FQPA factor is applicable for all populations. Cancer Classification The HED RfD/ Peer Review classified disulfoton as a Group E chemical, meaning that it is not classifiable for carcinogenicity based on a lack of evidence in a carcinogenicity study in mice and rats at dose levels adequate to test for carcinogenicity. 12 SUMMARY OF USE PATTERN AND FORMULATIONS Homeowner Use Products The Agency acknowledges that this assessment includes some non­ occupational uses that are no longer supported by Bayer, but may be available on the market due to production by other 3 registrants or existing stock provisions. . The only non­ occupational uses supported by Bayer, at the time of this assessment, are those stated on the Bayer ready­ to­ use one percent granular label ( roses, ornamental flowers, and shrubs) . Type of pesticide/ target pests Disulfoton, ( O, O­ Diethyl S­ [ 2­ ( ethylthio) ethyl ] phosphorodithioate) ) is a selective systemic organophosphate insecticide used to control a variety of sucking insects. Insects that disulfoton controls include, but are not limited to, the following: 4 C Aphids, Birch leaf miner, Elm leaf beetle, European elm scale, Lace bug, Leafhoppers, Mites, Thrips, Whiteflies, Birch leafminers, Camellia scale, Holly leafminer, Leafhoppers, Mimosa webworm, Pine tip moth, Soft scale, Spider mites, Tea scale, Thrips and Whiteflies. Formulation types and percent active ingredient for residential products Disulfoton is formulated as a technical product ( 98.5 percent active ingredient) and as a residential­ use granular product ( two, one, and 0.37 percent active ingredient) . Bayer is currently only supporting the one percent granular product. Disulfoton is often formulated in combination with fertilizers. 4 Registered use sites 4,7 Non­ occupational­ use sites The Agency acknowledges that some non­ occupational use sites listed below are not supported by Bayer; however, these sites have been included for informational purposes because they may be supported by other registrants. Potential residential and non­ occupational use sites may include indoor or outdoor residential sites ( e. g. , exposure to insecticide use on ornamentals) . The non­ occupational use sites in this RED have been grouped as follows: C Residential Ornamental Flowers C C Residential Ornamental Shrubs and Trees C Residential Rose Bushes C Residential Vegetable Gardens C Residential Potted Plants Residential Application Rates 4,7 4 C Residential Ornamental Flowers : The maximum label application rate of the granular product not supported by Bayer is 0.3 lb ai/ 1,000 ft 2 . The maximum application rate for the Bayer one percent granular product is 0.21 lb ai/ 1000 ft 2 . The original assessment assumed a range of rates from 0.005 lb ai/ 1000 ft 2 to 0.3 lb ai/ 1000 ft 2 . C Residential Ornamental Shrubs and Small Trees: The maximum label application rate for the products not supported by Bayer is 0.016 lb ai/ 5­ inch diameter tree for the insecticidal spikes. The maximum application rate for the Bayer one percent granular product is 0.010 lb ai/ four foot shrub. The original assessment assumed a range of rates from 0.000321 lb ai/ four­ foot shrub to 1.32 lb ai/ four­ foot shrub. C Residential Rose Bushes: The maximum label application rate to rose bushes using the insecticidal spikes, which are not supported by Bayer, is 0.048 lb ai/ bush. The maximum application rate for both the Bayer one percent granular and the non­ Bayer supported granular product is 0.00125 lb ai/ bush. The original assessment assumed a rate of 0.00188 lb ai/ bush. C Residential Vegetable Gardens: The maximum label application rate is 0.069 lb ai/ 1000 ft 2 . Bayer does not support this use. The original assessment assumed a range of rates from 0.0313 lb ai/ 1000 ft 2 to 0.1125 lb ai/ 1000 ft 2 . C Residential Potted Plants: The maximum label application rate for hand application of granulars to pots is 0.00034 lb ai/ six inch pot. The maximum application using insecticidal spikes is 0.000063 lb ai/ six inch pot. Bayer does not support this use. The original assessment assumed a rate of 0.00011 lb ai/ six inch pot. Methods and Types of Equipment Used for Loading and Applying Residential Formulations: 4,7 The Agency acknowledges that some methods of application listed below are not supported by Bayer; however, these application methods and equipment have been included for informational purposes. C Residential Ornamental Flowers: Belly grinder and push­ type spreader applications can be used for preplanting treatment, or treatments can be applied using a spoon, measuring scoop, shaker can or by hand, and then soil incorporated. Regardless of application method, the revised assessment assumes that 1000 ft 2 are treated per day. The original assessment assumed 10,000 ft 2 were treated per day using belly grinder equipment and 1000 ft 2 per day using all other equipment. 5 C Residential Ornamental Shrubs : Applications are made by distributing granules uniformly under the shrub canopy using a push­ type spreader, spoon, measuring scoop, shaker can or by hand and soil incorporated and then watered in. Both the revised and original assessments assumed that 25 shrubs are treated per day. C Residential Rose Bushes: Belly grinder applications can be made for preplanting treatment. At planting, or to established bushes, application of granulars is made using a push­ type spreader, spoon, measuring scoop, shaker can or by hand. Both the revised and original assessments assumed that 50 rose bushes are treated per day. C Residential Vegetable Gardens: Belly grinder or push­ type spreader applications can be made for preplanting treatment. At planting application of granulars is made using a spoon, measuring scoop, shaker can or by hand. The revised assessment assumes that 1000 ft 2 are treated per day. The original assessment assumed that 10,000 ft 2 were treated per day. C Residential Potted Plants: Applications are made by hand by punching a hole into soil and pouring granules into the holes or sprinkling granules on the soil and soil incorporating. Both the revised and original assessments assumed that 20 six inch pots are treated per day. RESIDENTIAL RISK ASSESSMENT AND CHARACTERIZATION Non­ Occupational Exposure Scenarios HED has determined that residential and other non­ occupational handlers are likely to be exposed during disulfoton use. The anticipated use patterns and current labeling indicate several exposure scenarios based on the types of equipment that potentially can be used to make disulfoton applications. The Agency acknowledges that some exposure scenarios listed below are not supported by Bayer; however, these exposure scenarios have been included for informational purposes. These scenarios include: ( 1) loading/ applying granulars with a belly grinder; ( 2) loading/ applying granulars with a push­ type spreader; ( 3) loading/ applying granulars using a spoon, measuring scoop, shaker can or by hand; ( 4) loading/ applying Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care ® Disulfoton 1% % granulars by hand using a measuring cup/ lid; or ( 5) application of insecticidal spikes. Registrants indicate that only dry formulations ( i. e. , only granulars or pellets/ tablets/ spikes) are permitted to be used around residences. Handler Exposure Data ­ Surrogate PHED 6 Chemical­ specific data for assessing human exposures during pesticide handling activities were not submitted to the Agency in support of the reregistration of disulfoton, with the exception of a homeowner garden study ( MRID 453334­ 01) . It is the policy of HED to use data from the Pesticide Handlers Exposure Database ( PHED) Version 1.1 to assess handler exposures 8 for regulatory actions when chemical­ specific monitoring data are not available. The PHED Task Force is comprised of representatives from the U. S. EPA, Health Canada, the California Department of Pesticide regulation, and member companies of the American Crop Protection Association. PHED is a software system consisting of two parts: a database of measured exposure values for workers involved in the handling of pesticides under actual field conditions and a set of computer algorithms used to subset and statistically summarize the selected data. Currently, the database contains values for over 1,700 monitored individuals ( i. e. , replicates) . 8 Users select criteria to subset the PHED database to reflect the exposure scenario being evaluated. The subsetting algorithms in PHED are based on the central assumption that the magnitude of handler exposures to pesticides are primarily a function of activity ( e. g. , mixing/ loading, applying) , formulation type ( e. g. , wettable powders, granulars) , application method ( e. g. , aerial, groundboom) , and clothing scenarios ( e. g. , gloves, double layer clothing) . 8 Once the data for a given exposure scenario have been selected, the data are normalized ( i. e. , divided by) by the amount of pesticide handled resulting in standard unit exposures ( milligrams of exposure per pound of active ingredient handled) . Following normalization, the data are statistically summarized. The distribution of exposure values for each body part ( e. g. , chest upper arm) is categorized as normal, lognormal, or other ( ( i. e. , neither normal nor lognormal) . A central tendency value is then selected from the distribution of the exposure values for each body part. These values are the arithmetic mean for normal distributions, the geometric mean for lognormal distributions, and the median for all other distributions. . Once selected, the central tendency values for each body part are composited into a best fit exposure value representing the entire body. 8 The unit exposure values calculated by PHED generally range from the geometric mean to the median of the selected data set. While data from PHED provide the best available information on handler exposures, it should be noted that some aspects of the included studies ( e. g. , duration, acres treated, pounds of active ingredient handled) may not accurately represent labeled uses in all cases. HED has developed a series of tables of standard unit exposure values for many occupational scenarios that can be utilized to ensure consistency in exposure assessments. 8 In the revised assessment, PHED data are used to assess exposure from loading/ applying granulars with a belly grinder. In the original assessment, PHED data were used to assess exposure from loading/ applying granulars with belly grinder and push­ type spreader equipment, and from loading/ applying granulars by hand using a spoon, shaker can, or measuring scoop. 7 ORETF Some of the handler exposure data used in this assessment are from the Outdoor Residential Exposure Task Force ( ORETF) . The task force recently submitted proprietary data to the Agency on hose­ end sprayers, push­ type granular spreaders, and handgun sprayers ( MRID # 44972201) . The ORETF data were used in this assessment in place of PHED data for the loading/ applying granulars using a push­ type spreader scenario. . The ORETF data were designed to replace the present PHED data with higher­ confidence, higher quality data that 1 contains more replicates than the PHED data for those scenarios. Other Handler exposure data from a proprietary granular mixer/ loader/ applicator study ( MRID 452507­ 02) in bananas using fipronil ( Regent 20GR) were used in place of PHED data for the loading/ applying granulars using a spoon, measuring scoop, shaker can or by hand scenario. . This fipronil study is considered to be an appropriate source of surrogate handler exposure data for disulfoton because formulation types are similar ( granular) and application methods are similar ( applying granulars with a spoon) . The study is considered to be of sufficient quality for use in risk assessment. 3 Several factors should be considered when using fipronil data in the disulfoton exposure assessment. Protection factors used to calculate disulfoton dermal unit exposure values, based on the fipronil unit exposure values, include a standard 50% protection factor for the torso, a 10% protection factor for legs, based on shorts, and a 10% protection factor for arms, based on a short­ sleeved shirt. These protection factors represent the typical attire assumed to be worn by a homeowner during pesticide application ( shorts and short­ sleeved shirt) . The 10% protection factor for shorts and the 10% protection factor for a short­ sleeved shirt are not standard protection factors used by the Agency; rather, these values are based on the best professional judgement of Agency scientists and are appropriate for calculating range­ finding estimates only. Some other issues and limitations to be considered when using the fipronil study include the following: Agency guidelines require that 15 replicates be completed in exposure studies in three different locations. In the fipronil study, only ten replicates were completed using spoons, and at only one location. However, the events that were monitored seemed to be reasonable representations of actual agricultural practices, so it is unlikely that additional replicates would significantly alter the final unit exposure results. Additionally, it is unlikely that cultural practices would significantly vary if the study was completed at different locations. The individual amounts of chemical applied were not recorded in this study. Instead, the investigators determined how much product was applied by the application teams used. Using this information, the investigators calculated the amount used for each individual 8 by assuming that each was equally productive ( i. e. , dividing the total amount used per team by the number of team members) . One applicator using the spoons had a spoon with no handle. The results for this individual were included with the other spoon applicators as it is a plausible variation of that application method. The Agency notes that the geometric mean unit exposure value for spoon applications of fipronil was used for disulfoton risk assessment purposes. Handler Exposure Data ­ Chemical­ Specific Data Review of MRID # 453334­ 01: Disulfoton 1% Granular Residential Applicator Exposure and Risk Estimates 5 In support of the reregistration of disulfoton Bayer Corporation submitted a study estimating handler exposures. The purpose of this study was to quantify potential dermal ( forearm and hand) and inhalation exposure for residential applicators of Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care ® , a granular formulation, which contains 1.04 percent disulfoton as the active ingredient. The maximum application rate for flower beds ( 4 ounces formulated product per 12 square feet) and for shrubs ( 4 ounces formulated product per 1 foot shrub height) was used in this study. A total of 15 volunteers were monitored using passive dosimetry ( hand/ forearm wash solutions and personal air monitors) . Application of the product was made by pouring the granules into the measuring cup/ lid attached to the product package, and then distributing the granules onto the soil around the base of a shrub or onto a flower bed. The granules were then soil­ incorporated with a garden rake. A total of 30 replicates were reported. The test site was a fallow test field, approximately 1 acre in size. Two sets of sub­ plots were established: ( 1) shrub test­ plots, each containing 10 oleander shrubs ( approximately 48 inches high) ; and ( 2) flower­ bed sub­ plots, each containing simulated plants, ( e. g. , 12 to 14 inch high stakes placed on approximately 24 inch centers) . All of the inhalation exposure data were either non­ detect or less than the limit of quantitation ( LOQ = 0.3 F g) . Most of the hand/ forearm dermal washing samples returned results greater than the LOQ. The study was conducted in compliance with the major technical aspects of OPPTS Group A: 875.1300, Inhalation Exposure ­ ­ Outdoor and 875.1100, Dermal Exposure ­ ­ Outdoor, and Series 875 Group B, Part C, as they relate to this study. Reviewers noted the following deficiency: C EPA provided the registrant with comments on study outlines submitted to the Agency. The following comment was not fully addressed in the conduct of the 9 study, as both real plants and simulated plants were used: : The Agency prefers that the study use real plants Use of Simulated Plants because it is difficult, if not impossible, to tell how closely the simulated plant environment reflects what is actually encountered by a homeowner. If the registrant could not find a study site with enough roses or shrubs to treat, the Agency recommended that the study at least include a subset of real plants in established beds to compare the real and the simulated plants. . Data from this study were used in place of PHED data for estimating residential handler exposure and risk from applying Bayer Advanced 2­ in­ 1 Systemic Rose and Flower Care ® to roses, flowerbeds, and shrubs by hand. The geometric mean unit exposure value was used for risk assessment purposes. Non­ Occupational Handler Exposure Scenario Data and Assumptions Residential handler exposure assessments were completed by HED using a baseline exposure scenario. PHED values used to estimate daily unit exposure values were taken from the Standard Operating Procedures ( SOPs) for Residential Exposure Assessments and the Recommended Revisions to the Standard Operating Procedures for Residential Exposure Assessments Science Advisory Council for Exposure Policy # # 12. 6,11 Table 3 summarizes the caveats and parameters specific to the surrogate data used for each scenario and corresponding exposure/ risk assessment. The following assumptions and factors were used in order to complete this exposure assessment: Calculations are completed at the maximum application rates recommended by the available disulfoton labels to indicate worst­ case risk levels associated with the various use patterns. Application rates and exposure values were calculated separately for Bayer 1% granular product labels. Generally, the use of PPE and engineering controls are not considered acceptable options for products sold for use by homeowners because they are not available, and/ or inappropriate for the exposure scenario. PHED values represent a handler wearing typical residential clothing attire of short sleeve shirt, short pants, socks, shoes, and no gloves. The number of rose bushes assumed for treatment per day by a homeowner is 50 rose bushes. The number of pots assumed for treatment per day by a homeowner is 20 six­ inch pots. The number of ornamental shrubs or trees assumed for treatment per day by a 10 homeowner is 25 shrubs. The area treated with granulars for flower or vegetable gardens by a homeowner is assumed to be 1,000 ft 2 . For pre­ planting treatment of flower and vegetable gardens with a belly grinder or push­ type spreader, the treatment area is assumed to be 1,000 ft 2 . A respiratory rate of 16.7 L/ min was assumed, based on the draft NAFTA recommended inhalation rates. Non­ occupational Handler Exposure and Risk Estimates The calculations of daily dermal and inhalation exposure, short­ term doses, and total short­ term MOEs were made using the following formulae. 8 Potential daily dermal exposure is calculated using the following formula: Daily Dermal Exposure mg ai Unit Exposure mg ai xUse Rate lb ai x Daily Acres Treated A day lb ai A day The potential short­ term dermal doses were calculated using the following formulae: Short term Daily Dermal Dose mg ai Short term Daily Dermal Exposure mg ai x 1 kg / day day Body Weight ( kg ) The short­ term MOEs were calculated using a NOAEL of 0.5 mg/ kg/ day. The previous assessment used a short­ term dermal NOAEL of 0.4 mg/ kg/ day from a dermal rabbit study. The intermediate­ term MOEs were calculated using a NOAEL of 0.03 mg/ kg/ day assuming 36 percent dermal absorption and 70 kg body weight. Potential daily inhalation exposure was calculated using the following formula: Daily Inhalation Exposure mg ai day 1 mg A Unit Exposure F gai x Conversion Factor 1, 000 F g xUse Rate lb A ai x Daily Acres Treated day lb ai The potential short­ term inhalation doses were calculated using the following formulae: Short term Daily Inhalation Dose mg ai Short term Daily Inhalation Exposure mg ai x 1 kg / day day Body Weight ( kg ) 11 For disulfoton, the inhalation doses were calculated using a 70 kg body weight and an inhalation absorption rate of 100 percent. Table 4 presents residential dermal and inhalation exposures associated with the handling of disulfoton. Table 5 presents the short­ term dermal and inhalation risks as well as total MOEs resulting from those exposures. The Agency only assessed for short­ term non­ occupational ( residential) risks and not intermediate­ term non­ occupational ( residential) risks since it is assumed that handlers will be exposed less than seven days at a time. The Agency acknowledges that some exposure scenarios presented in the following tables may not be supported by Bayer; however, they may be supported by other registrants. Summary of Concerns for Non­ occupational Handlers, Data Gaps, and Confidence in Exposure and Risk Estimates Short­ term dermal and inhalation risks for homeowner­ handlers were assessed as well as the total risks associated with the handling of disulfoton. Handler Scenarios with Risk Concerns The calculations of short­ term dermal and inhalation risks indicate that the following total short­ term MOEs are greater than 100 at baseline: ( 2) loading/ applying granulars using a push­ type spreader ( 3) loading/ applying granulars using a spoon, measuring scoop, shaker can, or by hand for application to vegetable gardens, potted plants, and roses. The calculations of short­ term dermal and inhalation risks indicate that the following total short­ term MOEs are less than 100 at baseline: ( 1) loading/ applying granulars with a belly grinder for flower and vegetable gardens ( pre­ planting) using an application rate of 0.3 lb ai/ 1000 ft 2 ( flower gardens, MOE = 1.1) and 0.069 lb ai/ 1000 ft 2 ( vegetable gardens, MOE = 4.6) . ( 3) loading/ applying granulars, using a spoon, measuring scoop, shaker can or by hand, to flower gardens and ornamental shrubs/ small trees using an application rate of 0.3 lb ai/ 1000 ft 2 ( flower gardens, MOE = 34) and 0.01 lb ai/ four foot shrub ( shrubs/ small trees, MOE = 41) . The calculations of short­ term dermal and inhalation risks indicate that all total short­ term MOEs are greater than 100 at baseline for Bayer s Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care ® : ( 4) loading/ applying granulars using a measuring cup/ lid at an application rate of 0.21 lb ai/ 1000 ft 2 ( flowerbeds, MOE = 5500) , 0.01 lb ai/ four foot shrub ( shrubs, MOE = 1500) , and 12 0.0013 lb ai/ bush ( rosebushes, MOE = 5800) . The Agency notes that the Advanced Garden 2­ in­ 1 product is the only homeowner product that Bayer intends to support. Residential risks from the use of this product are not of concern. Data Gaps Data gaps exist for the following scenario: ( 5) applying insecticidal spikes to rose bushes, or ornamental shrubs and trees. Data Quality and Confidence in Assessment Several issues must be considered when interpreting the non­ occupational exposure risks Factors used to calculate daily exposures to handlers ( e. g. square footage treated per day, number of pots treated and number of shrubs or trees treated in a day) are based on the best professional judgement due to a lack of pertinent data. Non­ occupational Postapplication Scenarios HED has determined that there are potential postapplication exposures to residents based on the following scenarios: transplanting, hoeing, and weeding treated ornamental shrubs and trees ( including rose bushes) ; transplanting, hoeing, and weeding treated ornamental flowers; non­ harvest activities such as weeding and hoeing of home vegetable crops; incidental granular ingestion; and incidental soil ingestion. Data Source Descriptions for Scenarios Considered A surrogate postapplication exposure assessment was conducted to determine potential risks for incidental soil ingestion. Other postapplication scenarios were not assessed because disulfoton granulars and insecticidal spikes are applied directly to the soil and EPA has no data 13 upon which to base postapplication contact with treated soil through activities such as weeding, hoeing, and transplanting home ornamentals and vegetable crops or houseplants. Furthermore, it is HED s policy to routinely conduct screening level assessments ( based on standard values in the Residential SOPs) for children s incidental ingestion of granules when a granular pesticide may be applied in residential settings; however, the Agency has no data upon which to base this postapplication scenario. The Agency requests information on particle density ( number of particles per pound or gram) , carrier type, granular color, and average granular size in order to conduct an exposure assessment for this scenario. Assumptions Used in Postapplication Exposure Calculations The assumptions used in the calculations for residential postapplication risks include the following items: The oral NOAEL of 0.03 mg/ kg/ day from the six­ month feeding study in rats was used in the assessment. C On the day of application, it was assumed that 20 percent of the application rate is located with the soil s uppermost 1 cm. The Residential SOP s specify a 100 percent assumption; however after disulfoton treatment followed by soil incorporation, the insecticide should be uniformly dispersed into the top 2 inches of soil. 6 C The soil ingestion rate for children ( ages 1­ 6 years) was assumed to be 100 mg/ day. C Application rates used in the residential assessment are described in a previous section. C Toddlers ( 3 years old) used to represent the 1 to 6 year old age group, were assumed to weigh 15 kg. C Postapplication was assessed on the same day the pesticide is applied because it was assumed that the toddler could be exposed to soil immediately after application. Therefore, postapplication exposures were based on day 0. Postapplication Exposure and Risk Estimates Table 6 presents the postapplication risks from the incidental soil ingestion by toddlers of soil treated with disulfoton. The following equations were used: Incidental Soil Ingestion: ADD = ( SRt * IgR * CF1) / BW 14 where: ADD = average daily dose ( mg/ kg/ day) SRt = soil residue on day " t" ( F g/ g) , assuming average day of reentry t is day 0 IgR = ingestion rate of soil ( mg/ day) , assumed to be 100 mg/ day CF1 = weight unit conversion factor to convert the F g of residues on the soil to grams to provide units of mg/ day ( 1E­ 6 g/ F g) BW = body weight ( kg) , assumed 15 kg for toddlers and SRt = AR * F * ( 1­ D) t * CF2 * CF3 * CF4 where: AR = application rate ( lb ai/ acre) F = fraction of ai available in uppermost cm of soil ( fraction/ cm) , assumed to be 20 percent based on soil incorporation into top 2 inches of soil after application D = fraction of residue that dissipates daily ( unitless) t = postapplication day on which exposure is being assessed CF2 = weight unit conversion factor to convert the lbs ai in the application rate to F g for the soil residue value ( 4.54E8 F g/ lb) CF3 = area unit conversion factor to convert the surface area units ( ft 2 ) in the application rate to cm 2 for the SR value ( 2.47E­ 8 acre/ cm 2 if the application rate is per acre) CF4 = volume to weight unit conversion factor to convert the volume units ( cm 3 ) to weight units for the SR value ( 0.67 cm 3 / g soil) 7 t = postapplication day on which exposure is being assessed, assumed to be day 0 Summary of Residential Postapplication Risks The target residential MOE is 100 for disulfoton. The resulting surrogate residential postapplication assessment for toddlers indicates that the disulfoton MOEs for incidental soil ingestion are greater than 100 for flower garden soil and vegetable garden soil ( application rates 13 lbs ai/ A and 3 lbs ai/ A, respectively) . Data Gaps Data gaps exist for the following scenarios: transplanting, hoeing, and weeding treated ornamental shrubs and trees ( including rose bushes) ; transplanting, hoeing, and weeding treated ornamental flowers; 15 non­ harvest activities such as weeding and hoeing of home vegetable crops; incidental granular ingestion ( information on particle density, carrier type, granular color, and average granular size) 16 Table 3. Residential Exposure Scenario Descriptions for the Use of Disulfoton Exposure Scenario ( Scenario # ) Data Source Comments a Standard Assumptions 6,11 Loading/ applying granulars using a belly grinder ( 1) PHED V1. 1 Baseline: Dermal and hands data = ABC grades, inhalation = AB grade. Dermal 20­ 45 replicates; hands = 23 replicates; and inhalation = 40 replicates. Medium confidence for hands and dermal, and high confidence for inhalation. PPE and Engineering Controls : Not required for assessment. 1, 000 ft 2 for pre­ planting of flower/ vegetable gardens per day Loading/ applying granulars using a push­ type spreader ( 2) Summary of HED s Reviews of Outdoor Residential Exposure Task Force ( ORETF) Chemical Handler Exposure Studies; MRID 449722­ 01. April 30, 2001. Baseline: Dermal, hands, and inhalation data = A/ B grade. Dermal, hands, and inhalation data = 30 replicates. High confidence in all data. PPE and Engineering Controls : Not required for assessment. 1, 000 ft 2 for pre­ planting of flower/ vegetable gardens and 25 shrubs per day Loading/ applying granulars using a spoon, measuring scoop, shaker can or by hand ( 3) Review of fipronil granular mixer/ loader/ applicator study as a source of surrogate data, MRID 452507­ 01. J. Dawson memo, D270065, 1/ 5/ 01. Baseline: A 90% protection factor was applied to gloved hands data to backcalculate no glove hand exposure. . A standard 50% protection factor was used for the torso. A 10% protection factor was used to represent the protection afforded by shorts and a short­ sleeved shirt. PPE and Engineering Controls : Not required for assessment. 1, 000 ft 2 for pre­ planting of flower/ vegetable gardens, 25 shrubs, and 50 rose bushes per day Loading/ applying Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care ® Disulfoton 1% granulars using a measuring cup/ lid ( 4) Disulfoton 1% Granular Residential Applicator Exposure and Risk Estimates: Report Number: 110137 5 25 shrubs and 50 rose bushes per day Application of insecticidal spikes ( 5) NA NA NA a " Best Available" grades are defined by HED SOP for meeting Subdivision U Guidelines. Best available grades are assigned as follows: matrices with grades A and B data and a minimum of 15 replicates; if not available, then grades A, B and C data and a minimum of 15 replicates; if not available, then all data regardless of the quality and number of replicates. Data confidence are assigned as follows: High = grades A and B and 15 or more replicates per body part Medium = grades A, B, and C and 15 or more replicates per body part Low = grades A, B, C, D and E or any combination of grades with less than 15 replicates NA = Not Applicable 17 Table 4: Residential Handler Dermal and Inhalation Exposures to Disulfoton at Baseline Exposure Scenario ( Scenario # ) ( mg/ lb ai) a Baseline Dermal Unit Exposure ( g/ lb ai) b Baseline Inhalation Unit Exposure Maximum Application Rate c Crop Type or Target d Amount Handled Per Day e Daily Dermal Exposure ( mg/ day) f Daily Inhalation Exposure ( mg/ day) g Mixer/ Loader/ Applicator Exposure Loading/ applying granulars using a belly grinder ( 1) 110 62 0.3 lb ai/ 1000 ft 2 Flower Gardens ( pre­ planting) 1,000 ft 2 33 0.019 0.069 lb ai/ 1000 ft 2 Vegetable Gardens ( pre­ planting) 1,000 ft 2 7.8 0. 0043 Loading/ applying granulars using a push­ type spreader ( 2) 0.68 0.91 0.069 lb ai/ 1000 ft 2 Vegetable Gardens 1, 000 ft 2 0.047 6.3E­ 5 0.3 lb ai/ 1000 ft 2 Flower Gardens 1, 000 ft 2 0.20 2.7E­ 4 0.01 lb ai/ 4 ft shrub Ornamental Shrubs 25 shrubs 0.17 2.3E­ 4 0.0013 lb ai/ bush Roses 50 bushes 0.043 5.7E­ 4 18 Table 4: Residential Handler Dermal and Inhalation Exposures to Disulfoton at Baseline ( continued) Exposure Scenario ( Scenario # ) Baseline Dermal Unit Exposure ( mg/ lb ai) a Baseline Inhalation Unit Exposure ( g/ lb ai) b Maximum Application Rate Crop Type or Target d Amount Handled Per Day e Daily Dermal Exposure ( mg/ day) f Daily Inhalation Exposure ( mg/ day) g Loading/ applying granulars using a spoon, measuring scoop, shaker can or by hand ( 3) 3.5 0. 045 0.069 lb ai/ 1,000 ft 2 Vegetable Gardens 1, 000 ft 2 0.24 3.1E­ 6 0.3 lb ai/ 1000 ft 2 Flower Gardens 1, 000 ft 2 1.04 1.4E­ 5 0.01 lb ai/ 4 ft shrub Ornamental Shrubs 25 shrubs 0.86 1.1E­ 5 0.00034 lb ai/ 6" pot Potted Plant 20 pots 0. 023 3.0E­ 7 0.0013 lb ai/ bush Roses 50 bushes 0.22 2.8E­ 6 Loading/ applying Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care ® Disulfoton 1% % granulars using a measuring cup/ lid ( 4) 0.03 0.013 0.21 lb ai/ 1000 ft 2 Flowerbeds 1,000 ft 2 0.0063 2.7E­ 6 0.092 0.013 0.01 lb ai/ 4 ft. bush Shrubs 25 0.023 3.3E­ 6 0.092 0.013 0.0013 lb ai/ bush Roses 50 bushes 0. 0060 8.5E­ 7 Application of insecticidal spikes ( 5) No Data No Data No Data No Data No Data No Data No Data Table 4: Residential Handler Dermal and Inhalation Exposures to Disulfoton at Baseline ( continued) 19 Footnotes: a Baseline Dermal Unit Exposure represents short pants, short sleeved shirt, no gloves, and open mixing/ loading. b Baseline Inhalation Exposure represents no respirator. c Application Rates are maximum rate values found on disulfoton labels ( EPA Reg. No. 4­ 153, 3125­ 517, 7401­ 323, 8660­ 191, 9404­ 3, 46260­ 2, 46260­ 12, 46260­ 35) . d Crop Type or Target provides a general description of the intended uses of disulfoton. Separate categories are presented because of the distinct differences in application rates and amount handled. e Daily Amount Handled values are default estimates from Exposure SAC Policy 12, or the best professional judgement of square footage, or number of bushes, shrubs, or pots that could be treated in a single day for each exposure scenario. 12 f Daily Dermal Exposure ( mg/ day) = Unit Exposure ( mg/ lb ai) * Appl. rate * Amount Handled per day. g Daily Inhalation Exposure ( mg/ day) = Unit Exposure ( µ g/ lb ai) * ( 1mg/ 1000 µ g) Conversion * Application Rate ( lb ai/ A) * Acres treated ( acres/ day) . h Residential application of disulfoton using a belly grinder are applicable for pre­ plant treatment applications only. I Unit exposure data for application of granules by hand were used as surrogate values for these scenarios. j Application rates for small vegetable gardens are based on 38­ inch row spacing ( EPA Reg. No. 7401­ 323) . 20 Table 5: Residential Handler Short­ term Risks from Disulfoton at Baseline Exposure Scenario ( Scenario # ) Crop Type or Target a Amount Handled Per Day b Maximum Application Rate Baseline Dermal Baseline Inhalation Baseline Total Daily Dose ( mg/ kg/ day) c Short term MOE d Daily Dose ( mg/ kg/ day) e Short term MOE f Short­ term MOE g Mixer/ Loader/ Applicator Risks Loading/ applying granulars using a belly grinder ( 1) Flower Gardens ( pre­ planting) 1,000 ft 2 0.3 lb ai/ 1000 ft 2 0.47 1.1 2. 7E­ 4 170 1.1 Vegetable Gardens ( pre­ planting) 1,000 ft 2 0.069 lb ai/ 1000 ft 2 0.11 4.6 6. 1E­ 5 740 4.6 Loading/ applying granulars using a push­ type spreader ( 2) Vegetable Gardens 1, 000 ft 2 0.069 lb ai/ 1,000 ft 2 h 6.7E­ 4 750 1.0E­ 6 5.0E4 740 Flower Gardens 1, 000 ft 2 0.3 lb ai/ 1,000 ft 2 0.0029 172 4.0E­ 6 1.2E4 170 Ornamental Shrubs/ Small Trees 25 shrubs 0.01 lb ai/ 4 ft. shrub 0. 0024 210 3.0E­ 6 1.4E4 200 Roses 50 bushes 0. 00126 lb ai/ bush 6. 1E­ 4 820 1.0E­ 6 5.5E4 810 21 Table 5: Residential Handler Short­ term Risks from Disulfoton at Baseline ( continued) Exposure Scenario ( Scenario # ) Crop Type or Target a Amount Handled Per Day b Maximum Application Rate Baseline Dermal Baseline Inhalation Baseline Total Daily Dose ( mg/ kg/ day) c Short term MOE d Daily Dose ( mg/ kg/ day) e Short term MOE f Short­ term MOE g Mixer/ Loader/ Applicator Risks Loading/ applying granulars using a spoon, measuring scoop, shaker can or by hand ( 3) Vegetable Gardens 1, 000 ft 2 0.069 lb ai/ 1,000 ft 2 h 0.0034 150 4.4E­ 8 1.0E6 150 Flower Gardens 1, 000 ft 2 0.3 lb ai/ 1,000 ft 2 0.015 34 1.9E­ 7 2.3E5 34 Ornamental Shrubs/ Small Trees 25 shrubs 0.01 lb ai/ 4 ft. shrub 0. 012 41 1.6E­ 7 2.8E5 41 Potted Plants 20 pots 0. 00034 lb ai/ 6" pot 3.3E­ 4 1500 4E­ 9 1.0E7 1500 Roses 50 bushes 0. 00126 lb ai/ bush 0. 0031 160 4.1E­ 8 1.1E6 160 22 Table 5: Residential Handler Short­ term Risks from Disulfoton at Baseline ( continued) Exposure Scenario ( Scenario # ) Crop Type or Target a Amount Handled Per Day b Maximum Application Rate Baseline Dermal Baseline Inhalation Baseline Total Daily Dose ( mg/ kg/ day) c Short term MOE d Daily Dose ( mg/ kg/ day) e Short term MOE f Short­ term MOE g Mixer/ Loader/ Applicator Risks Loading/ applying Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care ® Disulfoton 1% % granulars using a measuring cup/ lid ( 4) Flowerbeds 1000 ft 2 0.21 lb ai/ 1000 ft 2 9.0E­ 5 5600 3.9E­ 8 1.2E6 5500 Shrubs 25 shrubs 0.01 lb ai/ 4 ft shrub 3. 3E­ 4 1500 4.6E­ 8 9.7E5 1500 Roses 50 bushes 0. 0013 lb ai/ bush 9. 0E­ 5 5900 1.2E­ 8 3.7E6 5800 Application of insecticidal spikes ( 5) Roses/ Trees No Data No Data No Data No Data No Data No Data No Data Footnotes: a Crop Type or Target provides a general description of the intended use of various products containing disulfoton. Separate categories are presented because of the distinct differences in application rates and acres treated. b Amount Handled Per Day values are from default estimates of square footage or number of bushes, shrubs, or pots treated a single day for each exposure scenario of concern. Daily Dermal Dose ( mg/ kg/ day) = Daily Dermal Exposure ( mg/ day) / Body weight ( 70 kg) . d Short­ term Dermal MOE = NOAEL ( 0.5 mg/ kg/ day) / Daily Dermal Dose ( mg/ kg/ day) . e Daily Inhalation Dose ( mg/ kg/ day) = Daily Inhalation Exposure ( mg/ day) / Body weight ( 70 kg) . f Short­ term Inhalation MOE = NOAEL ( 0.045 mg/ kg/ day) / Daily Inhalation Dose ( mg/ kg/ day) . g Total Short­ term MOE = 1/ [ ( 1/ Short­ term Dermal MOE) + ( 1/ Short­ term Inhalation MOE) ] . h Application rates for small vegetable gardens are based on 38­ inch row spacing ( EPA Reg No. 7401­ 323) . 23 c Table 6. Residential Post­ application Risks from Incidental Soil Ingestion of Disulfoton Scenario Receptor Application Rate Per Treatment ( AR) ( lbs ai/ A) a Srt ( g/ g) b IgR ( mg/ day) BW ( kg) ADD ( mg/ kg/ day) MOE d Incidental soil ingestion ( flowerbeds) Toddler 13 20 100 15 0.00013 230 Incidental soil ingestion ( vegetable garden beds) Toddler 3 4. 5 100 15 0.00003 1000 Footnotes: a Application rate for flower and vegetable gardens b Soil residue ( ug/ g) = [ AR ( lbs ai/ A) * 4.54E+ 8 ug/ lb * 2.47E­ 8 A/ cm 2 * 0.67 cm 3 / g soil * 0.2/ cm ] . Average daily dose ( ADD) ( mg/ kg/ day) = [ SRt ( ug/ g) * IgR ( mg/ day) * g/ 1,000,000 ug ] / / [ BW ( kg) ] . d MOE = NOAEL ( 0.03 mg/ kg/ day) / ADD. 24 c References 1) Bangs, G. ( 2001) Summary of HED s Reviews of Outdoor Residential Exposure Task Force ( ORETF) Chemical Handler Exposure Studies; MRID 449722­ 01. Memorandum from Gary Bangs ( HED) to Demson Fuller ( Special Review and Reregistration Division) , April 30, 2001. 2) Becker, J. ( 2000) Revised Occupational and Residential Exposure Assessment and Recommendations for the Reregistration Eligibility Decision Document for Disulfoton. Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. February 7, 2000. 3) Dawson, J. ( 2001) Ethoprop. Review of fipronil granular mixer/ loader/ applicator study ( MRID 452507­ 01) in bananas as a source of surrogate data and accompanying ethoprop risk assessment Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. January 5, 2001. 4) Disulfoton Labels ( 4­ 153, 4­ 420, 16­ 171, 192­ 74, 192­ 119, 192­ 126, 192­ 164, 239­ 2134, 769­ 908, 802­ 426, 869­ 76, 869­ 223, 904­ 138, 3125­ 83, 3125­ 116, 3125­ 152, 3125­ 152, 3125­ 517, 5887­ 67, 5887­ 171, 7401­ 4, 4701­ 26, 7401­ 235, 7401­ 323, 9404­ 3, 8660­ 125, 8660­ 191, 11474­ 17, 32802­ 32, 42057­ 51, 46260­ 2, 46260­ 35, 59144­ 23) . 5) Merricks, D. Larry. ( 2001) Determination of Dermal ( Hand and Forearm) and Inhalation Exposure to Disulfoton Resulting from Residential Application of Bayer Advanced Garden 2­ in­ 1Systemic Rose and Flower Care to Shrubs and Flower Beds. MRID # 45333401. February 8, 2001. 6) U. S. EPA ( 1997) Standard Operating Procedures ( SOPs) for Residential Exposure Assessments, draft report. Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. December 18, 1997. 7) U. S. EPA ( 1998) Disulfoton LUIS Table for Exposure Assessors ( PRD report dated 11/ 06/ 96 and report run date 02/ 04/ 98) . 8) U. S. EPA ( 1998) PHED Surrogate Exposure Guide, Version 1.1. Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. August 1991. 9) U. S. EPA ( 1999) Use of Values from the PHED Surrogate Table and Chemical­ Specific Data, Science Advisory Council for Exposure Policy No. 7. Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. January 28, 1999. 10) U. S. EPA ( 2000) Disulfoton. Report of the FQPA Committee. Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. February 10, 2000 25 11) U. S. EPA ( 2001) Recommended Revisions to the Standard Operating Procedures ( SOPs) for Residential Exposure Assessments, Science Advisory Council for Exposure Policy No. 12. Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. February 22, 2001. 12) U. S. EPA ( 2001) Disulfoton: Revised ( 3 rd ) Report of Hazard Identification Assessment Review Committee. Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. April 10, 2001. cc: David Anderson, OPP/ HED/ RRB2 OREB Files 26

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Supporting & Related Material

August 9, 2001 MEMORANDUM SUBJECT: Addendum to the Revised Residential Exposure Assessment and Recommendations for the Reregistration Eligibility Decision Document for Disulfoton. D276829. FROM: Christina Jarvis, Environmental Protection Specialist Reregistration Branch 2 Health Effects Division ( 7509C) THROUGH: Alan Nielsen, Branch Senior Scientist Reregistration Branch 2 Health Effects Division ( 7509C) TO: Christina Scheltema Reregistration Branch 3 Special Review and Reregistration Division ( 7508W) Attached please find the revised Tables 4 and 5 for the disulfoton residential risk assessment chapter. These tables supercede tables 4 and 5 from the May 31, 2001 document titled Revised Residential Exposure Assessment And Recommendations For The Reregistration Eligibility Decision Document For Disulfoton ( ( S. Recore and C. Jarvis memo, D275170) . The only changes in these tables are the correction of the inhalation unit exposure value for the Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care ® from 0.013 F g/ lbs ai to 13 F g/ lbs ai and the corresponding inhalation risk values. Short­ term inhalation MOEs and total short­ term MOEs associated with the use of Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care ® are still considered to be above the Agency s level of concern ( MOEs > 100) . Table 4: Residential Handler Dermal and Inhalation Exposures to Disulfoton at Baseline Exposure Scenario ( Scenario # ) Baseline Dermal Unit Exposure ( mg/ lb ai) a Baseline Inhalation Unit Exposure ( F g/ lb ai) b Maximum Application Rate c Crop Type or Target d Amount Handled Per Day e Daily Dermal Exposure ( mg/ day) f Daily Inhalation Exposure ( mg/ day) g Mixer/ Loader/ Applicator Exposure Loading/ applying granulars using a belly grinder ( 1) 110 62 0.3 lb ai/ 1000 ft 2 Flower Gardens ( pre­ planting) 1,000 ft 2 33 0.019 0.069 lb ai/ 1000 ft 2 Vegetable Gardens ( pre­ planting) 1,000 ft 2 7.8 0. 0043 Loading/ applying granulars using a push­ type spreader ( 2) 0.68 0.91 0.069 lb ai/ 1000 ft 2 Vegetable Gardens 1, 000 ft 2 0.047 6.3E­ 5 0.3 lb ai/ 1000 ft 2 Flower Gardens 1, 000 ft 2 0.20 2.7E­ 4 0.01 lb ai/ 4 ft shrub Ornamental Shrubs 25 shrubs 0.17 2.3E­ 4 0.0013 lb ai/ bush Roses 50 bushes 0.043 5.7E­ 4 Table 4: Residential Handler Dermal and Inhalation Exposures to Disulfoton at Baseline ( continued) Exposure Scenario ( Scenario # ) Baseline Dermal Unit Exposure ( mg/ lb ai) a Baseline Inhalation Unit Exposure ( F g/ lb ai) b Maximum Application Rate Crop Type or Target d Amount Handled Per Day e Daily Dermal Exposure ( mg/ day) f Daily Inhalation Exposure ( mg/ day) g Loading/ applying granulars using a spoon, measuring scoop, shaker can or by hand ( 3) 3.5 0. 045 0.069 lb ai/ 1,000 ft 2 Vegetable Gardens 1, 000 ft 2 0.24 3.1E­ 6 0.3 lb ai/ 1000 ft 2 Flower Gardens 1, 000 ft 2 1.04 1.4E­ 5 0.01 lb ai/ 4 ft shrub Ornamental Shrubs 25 shrubs 0.86 1.1E­ 5 0.00034 lb ai/ 6" pot Potted Plant 20 pots 0. 023 3.0E­ 7 0.0013 lb ai/ bush Roses 50 bushes 0.22 2.8E­ 6 Loading/ applying Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care ® Disulfoton 1% % granulars using a measuring cup/ lid ( 4) 0.03 13 0.21 lb ai/ 1000 ft 2 Flowerbeds 1,000 ft 2 0.0063 2.7E­ 3 0.092 13 0.01 lb ai/ 4 ft. bush Shrubs 25 0.023 3.3E­ 3 0.092 13 0.0013 lb ai/ bush Roses 50 bushes 0. 0060 8.5E­ 4 Application of insecticidal spikes ( 5) No Data No Data No Data No Data No Data No Data No Data Table 4: Residential Handler Dermal and Inhalation Exposures to Disulfoton at Baseline ( continued) Footnotes: a Baseline Dermal Unit Exposure represents short pants, short sleeved shirt, no gloves, and open mixing/ loading. b Baseline Inhalation Exposure represents no respirator. c Application Rates are maximum rate values found on disulfoton labels ( EPA Reg. No. 4­ 153, 3125­ 517, 7401­ 323, 8660­ 191, 9404­ 3, 46260­ 2, 46260­ 12, 46260­ 35) . d Crop Type or Target provides a general description of the intended uses of disulfoton. Separate categories are presented because of the distinct differences in application rates and amount handled. e Daily Amount Handled values are default estimates from Exposure SAC Policy 12, or the best professional judgement of square footage, or number of bushes, shrubs, or pots that could be treated in a single day for each exposure scenario. 12 f Daily Dermal Exposure ( mg/ day) = Unit Exposure ( mg/ lb ai) * Appl. rate * Amount Handled per day. g Daily Inhalation Exposure ( mg/ day) = Unit Exposure ( µ g/ lb ai) * ( 1mg/ 1000 µ g) Conversion * Application Rate ( lb ai/ A) * Acres treated ( acres/ day) . h Residential application of disulfoton using a belly grinder are applicable for pre­ plant treatment applications only. I Unit exposure data for application of granules by hand were used as surrogate values for these scenarios. j Application rates for small vegetable gardens are based on 38­ inch row spacing ( EPA Reg. No. 7401­ 323) . Table 5: Residential Handler Short­ term Risks from Disulfoton at Baseline Exposure Scenario ( Scenario # ) Crop Type or Target a Amount Handled Per Day b Maximum Application Rate Baseline Dermal Baseline Inhalation Baseline Total Daily Dose ( mg/ kg/ day) c Short term MOE d Daily Dose ( mg/ kg/ day) e Short term MOE f Short­ term MOE g Mixer/ Loader/ Applicator Risks Loading/ applying granulars using a belly grinder ( 1) Flower Gardens ( pre­ planting) 1,000 ft 2 0.3 lb ai/ 1000 ft 2 0.47 1.1 2. 7E­ 4 170 1.1 Vegetable Gardens ( pre­ planting) 1,000 ft 2 0.069 lb ai/ 1000 ft 2 0.11 4.6 6. 1E­ 5 740 4.6 Loading/ applying granulars using a push­ type spreader ( 2) Vegetable Gardens 1, 000 ft 2 0.069 lb ai/ 1,000 ft 2 h 6.7E­ 4 750 1.0E­ 6 5.0E4 740 Flower Gardens 1, 000 ft 2 0.3 lb ai/ 1,000 ft 2 0.0029 172 4.0E­ 6 1.2E4 170 Ornamental Shrubs/ Small Trees 25 shrubs 0.01 lb ai/ 4 ft. shrub 0. 0024 210 3.0E­ 6 1.4E4 200 Roses 50 bushes 0. 00126 lb ai/ bush 6. 1E­ 4 820 1.0E­ 6 5.5E4 810 Table 5: Residential Handler Short­ term Risks from Disulfoton at Baseline ( continued) Exposure Scenario ( Scenario # ) Crop Type or Target a Amount Handled Per Day b Maximum Application Rate Baseline Dermal Baseline Inhalation Baseline Total Daily Dose ( mg/ kg/ day) c Short term MOE d Daily Dose ( mg/ kg/ day) e Short term MOE f Short­ term MOE g Mixer/ Loader/ Applicator Risks Loading/ applying granulars using a spoon, measuring scoop, shaker can or by hand ( 3) Vegetable Gardens 1, 000 ft 2 0.069 lb ai/ 1,000 ft 2 h 0.0034 150 4.4E­ 8 1.0E6 150 Flower Gardens 1, 000 ft 2 0.3 lb ai/ 1,000 ft 2 0.015 34 1.9E­ 7 2.3E5 34 Ornamental Shrubs/ Small Trees 25 shrubs 0.01 lb ai/ 4 ft. shrub 0. 012 41 1.6E­ 7 2.8E5 41 Potted Plants 20 pots 0. 00034 lb ai/ 6" pot 3.3E­ 4 1500 4E­ 9 1.0E7 1500 Roses 50 bushes 0. 00126 lb ai/ bush 0. 0031 160 4.1E­ 8 1.1E6 160 Table 5: Residential Handler Short­ term Risks from Disulfoton at Baseline ( continued) Exposure Scenario ( Scenario # ) Crop Type or Target a Amount Handled Per Day b Maximum Application Rate Baseline Dermal Baseline Inhalation Baseline Total Daily Dose ( mg/ kg/ day) c Short term MOE d Daily Dose ( mg/ kg/ day) e Short term MOE f Short­ term MOE g Mixer/ Loader/ Applicator Risks Loading/ applying Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care ® Disulfoton 1% granulars using a measuring cup/ lid ( 4) Flowerbeds 1000 ft 2 0.21 lb ai/ 1000 ft 2 9.0E­ 5 5600 3.9E­ 5 1.2E3 960 Shrubs 25 shrubs 0.01 lb ai/ 4 ft shrub 3. 3E­ 4 1500 4.6E­ 5 9.7E2 490 Roses 50 bushes 0. 0013 lb ai/ bush 9. 0E­ 5 5900 1.2E­ 5 3.7E3 1900 Application of insecticidal spikes ( 5) Roses/ Trees No Data No Data No Data No Data No Data No Data No Data Footnotes: a Crop Type or Target provides a general description of the intended use of various products containing disulfoton. Separate categories are presented because of the distinct differences in application rates and acres treated. b Amount Handled Per Day values are from default estimates of square footage or number of bushes, shrubs, or pots treated a single day for each exposure scenario of concern. Daily Dermal Dose ( mg/ kg/ day) = Daily Dermal Exposure ( mg/ day) / Body weight ( 70 kg) . d Short­ term Dermal MOE = NOAEL ( 0.5 mg/ kg/ day) / Daily Dermal Dose ( mg/ kg/ day) . e Daily Inhalation Dose ( mg/ kg/ day) = Daily Inhalation Exposure ( mg/ day) / Body weight ( 70 kg) . f Short­ term Inhalation MOE = NOAEL ( 0.045 mg/ kg/ day) / Daily Inhalation Dose ( mg/ kg/ day) . g Total Short­ term MOE = 1/ [ ( 1/ Short­ term Dermal MOE) + ( 1/ Short­ term Inhalation MOE) ] . h Application rates for small vegetable gardens are based on 38­ inch row spacing ( EPA Reg No. 7401­ 323) . c

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Supporting & Related Material

June 15, 2001 MEMORANDUM SUBJECT: REVISED OCCUPATIONAL EXPOSURE ASSESSMENT FOR THE REREGISTRATION ELIGIBILITY DECISION DOCUMENT FOR DISULFOTON FROM: Richard Griffin Reregistration Branch 2 Health Effects Division ( 7509C) TO: Christina Scheltema Reregistration Branch 3 Special Review and Reregistration Division ( 7508W) THRU: Al Nielsen, Branch Senior Scientist Reregistration Branch 2 Health Effects Division ( 7509C) Please find attached the revised occupational exposure and risk assessment for disulfoton. Please note that there are unresolved data compensation issues related to the Agency s use of proprietary data to assess the risks for handler scenarios involving loading/ applying granular formulations with a pump­ or gravity­ feed backpack spreader. The following changes necessitated this revised occupational exposure and risk assessment for disulfoton: 1) The registrant notified the Agency that it would not support several crops and use­ patterns that were included in the original risk assessment; 2) The registrant notified the Agency that it was reducing the maximum supported application rate for several crops; 3) The REVISED ( 3 nd ) Report of the Hazard Identification Assessment Review Committee for disulfoton issued January 18, 2001 established the short­ term dermal NOAEL for use in occupational and residential risks assessments at 0.5 mg/ kg/ day based on a newly submitted 3­ day dermal rat study the previous short­ ­ term dermal NOAEL for such assessments was 0.4 mg/ kg/ day; 4) The Health Effects Division on August 7, 2000 adopted revised Policy 3.1 from the Science Advisory Council for Exposure that presents interim transfer coefficients ( TC) for agricultural or commercial activities for use in post application exposure assessments; 5) The Health Effects Division on June 23, 2000 adopted revised Policy 9 from the Science Advisory Council for Exposure that provides standard values for the number of acres that can be treated in a single day by various types of agricultural equipment; 6) Newly available and better quality ORETF data for the push­ type granular spreader equipment is used in place of the PHED data set for this scenario; 7) Additional exposure scenarios were added because proprietary data became available to assess applying granular formulation with backpack equipment; 8) Newly available proprietary data were used to assess the exposure from the occupational scenario for applying granular with a bucket and spoon previously PHED data for applying granular bait by hand was used as a surrogate for this scenario; DP Barcode: D275169 Pesticide Chemical Codes: 032501 EPA Reg Nos. : 4­ 153, 4­ 253, 4­ 420, 16­ 171, 70­ 236, 192­ 74, 192­ 119, 192­ 126, 192­ 164, 239­ 2134, 572­ 346, 769­ 908, 802­ 426, 869­ 76, 869­ 223, 904­ 138, 3125­ 83, 3125­ 116, 3125­ 152, 3125­ 172, 3125­ 307, 3125­ 517, 5887­ 67, 5887­ 171, 7401­ 4, 4701­ 26, 7401­ 235, 7401­ 323, 9404­ 3, 8660­ 125, 8660­ 191, 11474­ 17, 32802­ 32, 34704­ 475, 42057­ 51, 46260­ 2, 46260­ 12, 46260­ 35, 59144­ 23; SLNs for 3125­ 172: ­ WA­ 850036; ­ ID­ 850016; ­ MT­ 800004; ­ OR­ 8000034; ­ NM­ 880001; NC­ 880001; ­ NC­ 920011; ­ WA­ 980004; SLNs for 3125­ 307: ­ CA­ 840192; ­ WA840036; ­ CA­ 760019; ­ CA­ 770036; ­ CA­ 770036; ­ CA­ 810044; ­ TX­ 900004; ­ OR­ 910027; ­ TX­ 860007; ­ WA­ 920026; PHED: Yes, Version 1.1 EXPOSURE AND RISK ASSESSMENT/ CHARACTERIZATION Purpose In this document, which is for use in EPA' s development of the Disulfoton Reregistration Eligibility Decision Document ( RED) , EPA presents the results of its review of the potential human health effects of occupational exposure to disulfoton. This memorandum revises the occupational exposure section of the February 7, 2000 memorandum titled Revised Occupational and Residential Exposure Assessment and Recommendations for the Reregistration Eligibility Decision Document for Disulfoton and the August 24, , 2000 memorandum titled Amendment to the the Disulfoton Occupational and Residential Exposure and Risk Assessment. 1,2 Criteria for Conducting Exposure Assessments An occupational exposure assessment is required for an active ingredient if ( 1) certain toxicological criteria are triggered and ( 2) there is potential exposure to handlers ( mixers, loaders, applicators, etc. ) during use or to persons entering treated sites after application is complete. For disulfoton, both criteria are met. Summary of Toxicity Concerns Relating to Occupational Exposure Acute Toxicology Categories Table 1 below presents the acute toxicity categories based on the active ingredient as outlined in the Hazard Identification document. 3 Table 1: Acute Toxicity Categories for Disulfoton Guideline No. Study Type MRID # . Results Toxicity Category 81­ 1 Acute Oral Acc# 072293 LD50 = M: 6. 2 mg/ kg; F: 1. 9 mg/ kg I 81­ 2 Acute Dermal Acc# 07793 LD50 = M: 15. 9 mg/ kg; F: 3. 6 mg/ kg I 81­ 3 Acute Inhalation Acc# 258569 LC50 = M: 0. 06 mg/ L; F: 0. 89 mg/ L I 81­ 4 Primary Eye Irritation None Data requirement waived. N/ A 81­ 5 Primary Skin Irritation None Data requirement waived. N/ A 81­ 6 Dermal Sensitization None Data requirement waived. N/ A 81­ 7 Acute Delayed Neurotoxicity 00129384 Equivocal. NA 81­ 8 Acute Neurotoxicity 42755801 Reversible neurotoxic signs consistent with the cholinesterase inhibition 1. 5 mg/ kg in females and 5. 0 mg/ kg in males. N/ A 1 Occupational and Residential Endpoints of Concern The revised Hazard Identification document for disulfoton, indicates that there are toxicological endpoints of concern for occupational exposure. The endpoints used in assessing the risks for disulfoton are presented in the following Table 2. 3 Table 2: Endpoints for Assessing Occupational Risks for Disulfoton Test Results Short­ term Dermal Exposure ( 1 to 7 days) 0. 5 mg/ kg/ day based on a 3­ day dermal study in rats ( Target MOE = 100) Intermediate­ term Dermal Exposure ( 1 week to several months) 0.03 mg/ kg/ day based on a special 6­ month cholinesterase inhibition feeding study ( Target MOE = 100) Inhalation Exposure ( All­ time periods) 0. 00016 mg/ L or 0.045 mg/ kg/ day based on a 90­ day inhalation study in rats ( Target MOE = 100) Dermal Absorption ( intermediate­ term dermal endpoint only) 36% Inhalation Absorption 100% SUMMARY OF USE PATTERN AND FORMULATIONS Type of pesticide/ target pests Disulfoton, ( O, O­ Diethyl S­ [ 2­ ( ethylthio) ethyl ] phosphorodithioate) ) is a selective systemic organophosphate insecticide used to control a variety of sucking insects. Examples of the type of insects that disulfoton controls include, but are not limited to, the following: 4 C vegetables and field crops: aphids, leafhoppers, Mexican bean beetle larvae, mites, thrips and potato psyllid, grasshoppers, flea beetles, southern potato wireworms, root aphids, green peach aphids, Colorado potato beetles, hessian fly; and C ornamental shrubs, trees and rose bushes: aphids, birch leaf miner, elm leaf beetle, European elm scale, lace bug, leafhoppers, mites, thrips, whiteflies, birch leafminers, camellia scale, holly leafminer, leafhoppers, mimosa webworm, pine tip moth, soft scale, spider mites, tea scale, thrips and whiteflies. Formulation types and percent active ingredient for occupational products 2 Disulfoton is formulated as a technical product ( 98.5 percent active ingredient) . It is formulated for occupational use as an emulsifiable concentrate ( 85, 23, and 17.5 percent active ingredient) , and as a granular ( 15, 10, 6.5, 2, 1, 0.625, 0.5, and 0.37 percent) . It is often formulated in combination with fertilizers. 4 Registered use sites for occupational products 4,5 C Agricultural Crops ( food and feed crops) , including peppers, broccoli, Brussels sprouts, cabbage, Chinese cabbage, cauliflower, clover grown for seed ( SLN only) , lettuce, asparagus ( SLN only) , radishes grown for seed ( SLN only) , barley, wheat, cotton, peanuts ( SLN only) , peas, sorghum, soybeans, white/ Irish potatoes, dried, lima, and snap beans, lentils, and tobacco; In the original assessment, the following crops were included, however, they are no longer being supported by Bayer and other registrants and have been dropped from this revised assessment: spinach, black and red raspberries, tomatoes, field corn, oats, triticale, sweet corn, sugar beets, popcorn, and strawberries ( propagating plants only) C Nut Trees and Non­ Bearing Fruit Trees: coffee trees; In the original assessment, the following crops were included, however, they are no longer being supported by Bayer and other registrants and have been dropped from this revised assessment: pecan trees and nonbearing apple, crabapple, pear, apricot, cherry, peach, plum and prune trees. C Forest Trees: poplars grown for pulp ( SLN only) ; C Ornamental Flowers/ Groundcover, including annuals and bulbs; C Ornamental Shrubs and Trees, including Christmas trees; and C Potted Plants: outdoor only In the original assessment, indoor ( i. e. , greenhouse) potted plants were included, however greenhouse uses are no longer being supported by Bayer and other registrants and have been dropped from this revised assessment. . Occupational Application Rates 4,5 C Emulsifiable Concentrate formulations: 4.0 lb/ A tobacco ( Reg # 3125­ 307) 3.0 lb/ A potatoes: foliar OR, WA, ID UT ( Reg # 3125­ 307) ; potatoes: soil ( Reg # 3125­ 307) ; poplars grown for pulpwood ( Reg # 3125­ 307­ ­ OR­ 910027) 2.5 lb/ A peas and lentils ( Reg # 3125­ 307) 3 2.0 lb/ A beans: dry, snap, lima ( Reg # 3125­ 307) ; cabbage ( Reg # 3125­ 307) ; lettuce ( Reg # 3125­ 307) ; peppers ( Reg # 3125­ 307) ; radish grown for seed ( Reg # 3125­ 307­ WA­ 920026) ; 1.0 lb/ A asparagus ( Reg # 3125­ 307­ CA­ 840192) ; barley ( Reg # 3125­ 307) ; broccoli ( Reg # 3125­ 307) ; Brussels sprouts ( Reg # 3125­ 307) ; cauliflower ( Reg # 3125­ 307) ; cotton ( Reg # 3125­ 307) ; sorghum ( Reg # 3125­ 307) ; wheat ( Reg # 3125­ 307) ; 0.75 lb/ A wheat ( Reg # 3125­ 307) 0.5 lb/ A sorghum ( Reg # 3125­ 307) ; potatoes: foliar ( Reg # 3125­ 307) 0.2 lb/ A cotton ( Reg # 3125­ 307­ TX­ 860007) C Granular formulations: 109 lb/ A field­ grown ornamental shrubs ( Reg # 3125­ 172) based on the assumption that the shrubs are two feet tall and occupy two square feet ( i. e. , roses) ; 78 lb/ A Christmas trees ( Reg # 3125­ 172) based on the assumption that the trunk is 2 inches in diameter and trees are planted at 1700 per acre; 37 lb/ A field­ grown ornamental trees ( Reg # 3125­ 172) based on the assumption that the trunk is 2 inches in diameters and trees are planted at 800 per acre; 29 lb/ A field­ grown flowers and groundcover ( Reg # 3125­ 172) 11 lb/ A field­ grown ornamental trees and shrubs: injection ( Reg # 3125­ 172) and lower rate for noninjection ( Reg # 3125­ 172) 8.3 lb/ A coffee trees ( Reg # 3125­ 172) based on the assumption that the trees are 8 feet tall and are planted 435 trees per acre 4.5 lb/ A Christmas trees ( ( Reg # 3125­ 172­ NC­ 880001) 4.0 lb/ A tobacco ( Reg # 3125­ 172) ; 3.0 lb/ A potatoes: soil ( Reg # 3125­ 172) ; 2.5 lb/ A peas and lentils ( Reg # 3125­ 172) ; 2.0 lb/ A peanuts ( Reg # 3125­ 172­ NC­ 920011) ; peppers ( Reg # 3125­ 172) ; radish grown for seed ( Reg # 3125­ 172­ WA­ 920027) ; 1.5 lb/ A cabbage ( Reg # 3125­ 172) ; 1.0 lb/ A barley ( Reg # 3125­ 172) ; beans: dry, snap, lima: ( Reg # 3125­ 172) ; broccoli ( Reg # 3125­ 172) ; Brussels sprouts ( Reg # 3125­ 172) ; cauliflower ( Reg # 3125­ 172) ; clover grown for seed ( Reg # 3125­ 172­ WA­ 980004) ; cotton ( Reg # 3125­ 172) ; peanuts ( Reg # 3125­ 172) ; sorghum ( Reg # 3125­ 172) ; soybeans ( Reg # 3125­ 172) ; wheat ( Reg # 3125­ 172) ; 0.2 lb/ day potted ornamentals ( Reg # 3125­ 172) ; based on the assumption that 350 pots that are 12 inches in diameter are treated each day. Application Methods, Types of Equipment Used, and Size of Area Treated 4,5 EPA estimates the area treated per day based on the type of equipment used on a specific crop. Acres treated per day values are based on HED Exposure SAC Policy # 009 Standard 4 Values for Daily Acres Treated in Agriculture, revised June 23, , 2000, or best professional judgment when data is not available. C For aerial equipment ( mix/ load, apply) the daily acres treated is 1200 acres per day for barley, cotton ( SLN) , sorghum, and wheat; flagging for such crops is given as 350 and 1200 acres per day; for aerial equipment ( mix/ load, apply, and flag) for all other crops is 350 acres per day; C For chemigation equipment the daily acres treated is 350 acres for broccoli, Brussels sprouts, cabbage, cauliflower, cotton, lettuce, poplars grown for pulp, and potatoes; C For groundboom spray equipment ( mix/ load and apply) the daily acres treated is 200 acres per day for barley, cotton, sorghum, and wheat; groundboom spray equipment for all other crops is 80 acres per day; C For tractor­ drawn granular equipment ( load and apply) the daily acres treated is 200 acres per day for barley, cotton, sorghum, soybeans, and wheat; tractor­ drawn granular equipment for coffee and all ornamental crops is 40 acres per day; the assumption for other crops is 80 acres per day; C For push­ type granular equipment ( load/ apply) the daily acres treated is 5 acres per day for ornamental shrubs, trees, Christmas trees, flowers, and groundcover; C For bellygrinder granular equipment ( load/ apply) the daily acres treated is 5 acres per day for ornamental shrubs, trees, Christmas trees, flowers, and groundcover; C For pump­ feed and gravity feed backpack granular spreaders and scoop/ bucket techniques ( load/ apply) , the daily acres treated ranges from 5 to 10 acres per day for ornamental shrubs, trees, Christmas trees, coffee trees, flowers, and groundcover; for applying to individual potted plants, the amount treated is 350 pots per day. OCCUPATIONAL RISK ASSESSMENT AND CHARACTERIZATION Occupational Handler Exposures Scenarios HED has determined that occupational handlers are likely to be exposed during disulfoton use. The anticipated use patterns and current labeling indicate several major exposure scenarios based on the types of equipment that potentially can be used to make disulfoton applications. These scenarios include: ( 1a) mixing, loading liquid formulations ( emulsifiable concentrates) for aerial application; ( 1b) mixing, loading liquid formulations ( emulsifiable concentrates) for chemigation application; ( 1c) mixing, loading liquid formulations ( emulsifiable concentrates) for groundboom application; ( 2a) loading granulars for aerial application; ( 2b) loading granulars for tractor­ drawn spreader application; ( 3) applying sprays with aircraft; ( 4) applying granulars with aircraft; ( 5) applying sprays with a groundboom; ( 6) applying granulars 5 with a tractor­ drawn spreader; ( 7) loading and applying granulars with a push­ type granular spreader; ( 8) loading and applying granulars using a belly grinder; ( 9a) loading and applying granulars with a pump­ feed backpack spreader; ( 9b) loading and applying granulars with a gravity­ feed backpack spreader; ( 10) loading and applying granulars with a scoop and bucket; ( 11) flagging during aerial spray applications; and ( 12) flagging during aerial granular applications. Loading and applying granulars with a motorcycle or all­ terrain vehicle equipped with a spreader is another known application method for ornamentals, including Christmas trees, however no data are available to assess this scenario. Handler Exposure Data ­ Surrogate Pesticide Handler Exposure Database ( PHED) The PHED Task Force is comprised of representatives from the U. S. EPA, Health Canada, the California Department of Pesticide regulation, and member companies of the American Crop Protection Association. PHED is a software system consisting of two parts: a database of measured exposure values for workers involved in the handling of pesticides under actual field conditions and a set of computer algorithms used to subset and statistically summarize the selected data. Currently, the database contains values for over 1,700 monitored individuals ( i. e. , replicates) . Users select criteria to subset the PHED database to reflect the exposure scenario being evaluated. The subsetting algorithms in PHED are based on the central assumption that the magnitude of handler exposures to pesticides are primarily a function of activity ( e. g. , mixing/ loading, applying) , formulation type ( e. g. , wettable powders, granulars) , application method ( e. g. , aerial, groundboom) , and clothing scenarios ( e. g. , gloves, double layer clothing) . Once the data for a given exposure scenario have been selected, the data are normalized ( i. e. , divided by) by the amount of pesticide handled resulting in standard unit exposures ( milligrams of exposure per pound of active ingredient handled) . Following normalization, the data are statistically summarized. The distribution of exposure values for each body part ( e. g. , chest upper arm) is categorized as normal, lognormal, or other ( ( i. e. , neither normal nor lognormal) . A central tendency value is then selected from the distribution of the exposure values for each body part. These values are the arithmetic mean for normal distributions, the geometric mean for lognormal distributions, and the median for all other distributions. . Once selected, the central tendency values for each body part are composited into a best fit exposure value representing the entire body. The unit exposure values calculated by PHED generally range from the geometric mean to the median of the selected data set. While data from PHED provide the best available information on handler exposures, it should be noted that some aspects of the included studies ( e. g. , duration, acres treated, pounds of active ingredient handled) may not accurately represent labeled uses in all cases. HED has developed a series of tables of standard unit exposure values for many occupational scenarios that can be utilized to ensure consistency in exposure assessments ( PHED Surrogate Exposure Guide, August 1998) . 6 6 In the revised assessment for occupational handlers, PHED data are used to assess exposure to scenarios ( 1) through ( 6) , ( 8) , ( 11) , and ( 12) . Outdoor Residential Exposure Task Force ( ORETF) The handler exposure data for loading/ applying granules with push­ type spreader equipment used in this revised occupational and residential assessment are from the Outdoor Residential Exposure Task Force ( ORETF) . 7 The task force recently submitted proprietary data to the Agency on hose­ end sprayers, push­ type granular spreaders, and handgun sprayers ( MRID # 44972201) . The ORETF data were used in this assessment in place of PHED data for the loading/ applying granulars using a push­ type spreader scenario. . The ORETF data were designed to replace the present PHED data with higher­ confidence, higher quality data that contains more replicates than the PHED data for those scenarios. 6,7 Proprietary Studies Worker Exposure Study During Application In Banana Plantation With Temik 10G , EPA MRID 451672­ 01: 8 In the revised occupational risk assessment, EPA used data from the aldicarb ( Temik) study to assess exposures and risks to handlers applying granulars with a pump feed backpack sprayer. In the original assessment, no data were available to assess this exposure scenario. Exposure during the application of a granular formulation of the insecticide, aldicarb ( i. e. , Temik 10G) , was monitored during granular backpack application to bananas for control of insects, mites, and nematodes. A total of 12 mixer/ loader/ applicator events during granular backpack ( i. e. , a specialized pump­ feed device manufactured by Swissmex Rapid) application to bananas were monitored during August of 1998 on the island of Martinique is in the French West Indies. Weather was typical of the application season in that it was hot, humid, and rainy at points. Monitoring was completed using whole body dosimeters, handwashes, facial wipes, and personal sampling pumps equipped with XAD resin/ filter combination samplers. Temik 10G was supplied in 22 pound boxes which was loaded directly into the backpack devices ( i. e. , 4 to 8 boxes were used per replicate) . The application rate for aldicarb used in this study is 20 grams of Temik 10G ( i. e. , 2 grams ai/ plant) which is equivalent to about 3.56 lb ai/ acre at approximately 2000 plants per acre. The numbers of acres treated ranged from approximately 2.5 to 5 acres. The pounds of active ingredient handled ranged from 8.8 up to 17.6 per replicate. Each applicator wore the whole body dosimeters covered by a cotton coverall, Tyvek gloves supplied with the Temik 10G formulation, and an apron on their backs between their backs and the backpack applicator. The Tyvek gloves were changed with each box of Temik 10G used. In many instances, the gloves were compromised because they were ripped. In one case, the gloves filled with rainwater. In many other cases, when the whole body dosimeters were removed, they were found to be wet and muddy. Analysis of aldicarb and its sulfoxide and sulfone degradates was completed. The 7 residue levels were added together to obtain total exposure levels. The limits of quantification ( LOQ) were 1.0 F g per sample for the whole­ body dosimeters and handwashes ( 600 mL volume) . The LOQ for the facial wipes was 0.10 F g per sample and 0.050 0.10 F g per sample for the air filters. Field and laboratory recovery data were generated for all media for all residues measured ( i. e. , parent and metabolites) . Field recovery data were generated in a manner that addressed field sampling, field storage, transport, laboratory storage, and analysis. Residues were corrected for the overall average field recovery for each residue/ matrix combination. Generally, recovery data were adequate for all media/ residue combinations. If the PHED grading criteria are applied all residue/ matrix combinations ( except facial wipes with sulfone residues) have at least grade B data and in many cases the data meet the grade A criteria. . The grade B criteria require laboratory recovery data with an average of at least 80 percent and a coefficient of variation of 25 or less accompanied with field recoveries that are at least 50 percent but not exceeding 120 percent. The grade A criteria require laboratory recovery data with an average of at least 90 percent and a coefficient of variation of 15 or less accompanied with field recoveries that are at least 70 percent but not exceeding 120 percent. Unit exposure values were calculated using the data from the study and a commercial spreadsheet program. The exposures that were calculated were normalized by the amount of chemical used, the duration of the application interval, and by the body weight of the individual applicators. For each calculation, the arithmetic mean, geometric mean, and various percentiles were calculated. No analyses were completed with these data to ascertain the exact type of distribution. The Agency typically uses the best fit values from the Pesticide Handlers Exposure Database which are representations of the central tendency. Considering the standard practice, the Agency will use the geometric mean for risk assessment purposes. Unit Exposure Values Type ( mg exp. / lb ai handled) ( mg exp. / hour) ( mg exp. / kg body weight/ day) Dermal Inhalation Dermal Inhalation Dermal Inhalation Geo. Mean 0.0995 0.0042 0.3979 0.0169 0.0409 0.0017 Worker Exposure Study During Application of Regent 20GR In Banana Plantation , EPA MRID 452507­ 02 9 In the revised occupational risk assessment, EPA used data from the fipronil ( Regent 20 GR) study to assess exposures and risks to handlers loading and applying granulars with a gravity feed backpack sprayer. In the original assessment, no data were available to assess this exposure scenario. In addition, in the revised occupational risk assessment, EPA used data from the fipronil study to assess exposures and risks to occupational handlers loading and applying granulars using a scoop and bucket. In the original assessment, PHED data for applying granulars by hand were used. However, this proprietary study is being substituted for the PHED data because the study data is higher­ confidence and higher quality. The Agency notes that unit exposure values derived from the fipronil study and used in place of PHED data for the disulfoton assessment are range­ finding estimates only. Exposure during the application of a granular formulation of the insecticide, fipronil ( i. e. , Regent 20GR) , was monitored during granular gravity­ feed backpack ( i. e. , Horstine Farmery 8 Microspread ® ) applications and spoon applications to bananas for control of insects, mites, and nematodes. A total of 18 mixer/ loader/ applicator events during granular backpack ( i. e. , a specialized gravity­ feed device manufactured by Horstine Farmery) or spoon application to bananas were monitored during applications on three different days in June, 1994 on the same banana plantation in Cameroon. The 18 replicates were distributed over the 3 sampling days as follows: 6 spoon/ hand applications on day 1; 4 spoon/ hand applications on day 2; and 8 backpack events on day 3. Weather was typical of the application season in that it was hot and humid. Monitoring was completed using whole body dosimeters, cotton gloves, cotton caps, and personal sampling pumps equipped with filters. Regent 20GR was supplied in 22 pound boxes which was loaded directly into the backpack devices or buckets for the spoon applicators. The application rate for fipronil used in this study is 7.5 grams of Regent 20GR ( i. e. , 0.15 grams ai/ plant) which is equivalent to about 0.26 lb ai/ acre ( 0.00033 lb ai/ plant) at approximately 800 plants per acre. The numbers of acres treated ranged from approximately 0.75 to 1 acre. The pounds of active ingredient handled ranged from about a quarter to half a pound per replicate. Each applicator wore whole body dosimeters that also served as the normal work clothing. PVC gloves were also worn over cotton gloves which served as the dosimeters. A protection factor of 50 percent was used by the Agency to calculate exposure levels under a layer of normal work clothing. Dosimeter samples were segmented into arms, legs, and torso for analysis. Analysis of fipronil residues was completed with gas chromatography and electron capture detection. The limits of quantification ( LOQ) were 9.7 F g per sample for all media used. The limit of detection ( LOD) varied for each media. The LOD for the cotton gloves was 0.5 F g per sample, 0.10 F g per sample for the air filters, and 2.0 to 4.0 F g per sample for the whole body dosimeters depending upon the sample analyzed. Field and laboratory recovery data were generated for all media. Field recovery data were generated in a manner that addressed field sampling, field storage, transport, laboratory storage, and analysis. However, the laboratory recovery data were indeterminate because the sample media could not be identified for each reported result. The overall recovery values do appear to be quantitative. Residues were corrected for the overall average field recovery for each residue/ matrix combination. Generally, recovery was adequate for all media/ residue combinations ( i. e. , all correction factors were greater than 85 percent) . If the PHED grading criteria are applied and the overall laboratory recovery averages are used all residue/ matrix combinations are considered grade A data. . The grade A criteria require laboratory recovery data with an average of at least 90 percent and a coefficient of variation of 15 or less accompanied with field recoveries that are at least 70 percent but not exceeding 120 percent. Unit exposure values were calculated using the data from the study and a commercial spreadsheet program. The exposures that were calculated were normalized by the amount of chemical used, the duration of the application interval, and by the body weight of the individual applicators ( see table below) . The values are based on a 50 percent clothing penetration factor and are separated for each equipment type monitored in this study. For each normalization factor, the arithmetic mean, geometric mean, and various percentiles were calculated. No analyses were completed with these data to ascertain the exact type of distribution. The Agency typically uses the best fit values from the Pesticide Handlers Exposure Database which are 9 representations of the central tendency. Considering the standard practice, the Agency will use the geometric mean for risk assessment purposes. Unit Exposure Values For Single Layer Clothing and Gloves Type ( mg exp. / lb ai handled) ( mg exp. / hour) ( mg exp. / kg body weight/ day) Dermal Inhalation Dermal Inhalation Dermal Inhalation Applications with a Spoon Geo. Mean 1.978 0.045 0.246 0.006 0.014 0.0003 Applications with a Horstine Farmery Microspread Geo. Mean 0.598 0.044 0.056 0.004 0.003 0.0002 Occupational Handler Exposure Scenario Data and Assumptions An exposure assessment for each scenario was developed, where appropriate data are available, using the Pesticide Handlers Exposure Database ( PHED) Version 1.1, 6 ORETF data, 7 and proprietary data. 8,9 Appendix Table 5 summarizes the caveats and parameters specific to the surrogate data used for each scenario and corresponding exposure/ risk assessment. These caveats include the source of the data and an assessment of the overall quality of the data. The assessment of data quality is based on the number of observations and the available quality control data. The quality control data are based on a grading criteria established by the PHED task force. 6 The following assumptions and factors were used in order to complete this occupational exposure assessment: C Average body weight of an adult handler is 70 kg. C Average work day interval represents an 8 hour workday ( e. g. , the acres treated or volume of spray solution prepared in a typical day are based on an 8 hour workday) . C Calculations are completed at the maximum application rates for specific crops recommended by the available disulfoton labels to estimate reasonable worse­ case risk levels associated with the various use patterns. C Due to a lack of scenario­ specific data, HED often calculates unit exposure values using generic protection factors ( PF) that are applied to represent various risk mitigation options ( i. e. , the use of Personal Protective Equipment ( PPE) and engineering controls) . PPE protection factors include those representing a double layer of clothing ( 50 percent PF) , chemical resistant gloves ( 90 percent PF) and respiratory protection ( 80 percent PF) for use of dust/ mist mask. Engineering controls are generally assigned a PF of 98 percent. Occupational Handler Exposure and Risk Estimates The calculations of daily dermal and inhalation exposure, short­ term and intermediate­ term doses, and dermal, inhalation, and total short­ and intermediate­ term MOEs were made 10 using the following formulae. Potential daily dermal exposure is calculated using the following formula: Daily Dermal Exposure mg ai ' Unit Exposure mg ai xUse Rate lb ai x Daily Acres Treated A day lb ai A day The potential short­ term and intermediate­ term dermal doses were calculated using the following formulae: Short & term Daily Dermal Dose mg ai ' Short & term Daily Dermal Exposure mg ai x 1 kg / day day Body Weight ( kg ) Interm & term Daily Dermal Dose mg ai ' Interm & term Daily Dermal Exposure mg ai x DermalAbsorption ( 0. 36) x 1 kg / day day BW ( kg ) The short­ term MOEs were calculated using a NOAEL of 0.5 mg/ kg/ day. The intermediate­ term MOEs were calculated using a NOAEL of 0.03 mg/ kg/ day assuming 36 percent dermal absorption. Potential daily inhalation exposure was calculated using the following formula: Daily Inhalation Exposure mg ai ' day 1 mg A Unit Exposure F gai x Conversion Factor 1, 000 F g xUse Rate lb A ai x Daily Acres Treated day lb ai The potential short­ term and intermediate­ term inhalation doses were calculated using the following formulae: Short & term Daily Inhalation Dose mg ai ' Short & term Daily Inhalation Exposure mg ai x 1 kg / day day Body Weight ( kg ) Intermediate & term Daily Inhalation Dose mg ai ' Intermediate & term Daily Inhalation Exposure mg ai x 1 kg / day day Body Weight ( kg ) For disulfoton, the inhalation doses were calculated using a 70 kg body weight and an inhalation absorption rate of 100 percent. Occupational handler exposure assessments are completed by EPA using a baseline exposure scenario and, if required, increasing levels of risk mitigation ( PPE and engineering 11 controls) to achieve an appropriate margin of exposure ( MOE) . The baseline scenario represents a handler wearing long pants, a long­ sleeved shirt, and no chemical­ resistant gloves. Table 3 below presents a summary of occupational handler risks of disulfoton by crop. The Appendix Tables 1 through 5 present risk assessment calculations for the occupational handling of disulfoton. Appendix Table 1 presents the dermal, inhalation, and total short­ and intermediate­ term risks at baseline attire. Appendix Table 2 presents the occupational dermal, inhalation, and total short­ term risks when wearing PPE risk mitigation. Appendix Table 3 presents the occupational dermal, inhalation, and total intermediate­ term risks when wearing PPE risk mitigation Appendix Table 4 presents the dermal, inhalation, and total short­ and intermediate­ term risks when engineering controls ( e. g. , closed systems for mixing/ loading, enclosed cab for applying or flagging, and enclosed cockpit for aerial applications are used. Appendix Table 5 summarizes the caveats and parameters specific to the surrogate data used for each scenario and corresponding exposure/ risk assessment. Engineering Controls for Mixing and Loading The engineering control available for mixing and loading pesticides is a closed system. In the Worker Protection Standard for Agricultural Pesticides ( WPS) ­ ­ 40 CFR Parts 156 and 170, closed systems are defined as systems designed by the manufacturer to enclose the pesticide to prevent it from contacting handlers or other people while it is being handled. Such systems must function properly and be used and maintained in accordance with the manufacturer' s written operating instructions. Under the WPS, when correctly using a closed system to mix and/ or load pesticides, handlers need not wear all the personal protective equipment listed on the pesticide labeling for handlers, but must wear at least: long­ sleeved shirt and long pants, shoes and socks, and chemical­ resistant gloves specified on the pesticide labeling for mixing, loading, and other handling tasks. If the formulation is a liquid, a chemical­ resistant apron is also required. The gloves and chemical­ resistant apron are required to protect the mixers/ loaders in case the closed systems breaks down. When using a closed system for liquid formulations that operates under pressure, handlers may wear the reduced PPE specified above, but must add protective eyewear even if the handler PPE does not require protective eyewear. NOTE: Under the WPS, when reduced PPE is worn because a closed system is being used, handlers must be provided all PPE specified on the labeling for handlers and have such PPE immediately available for use in a emergency, such as a spill or equipment break­ down. Closed Mixing/ Loading Systems for Liquid Formulations. There are various types of closed systems currently available for use with liquid formulations: C Water­ Soluble Packaging : One closed system is a type of packaging system where the liquid pesticide is formulated by the registrant into a gel and packaged into water­ soluble packets. When used correctly, water­ soluble packaging qualifies as a closed loading system under the WPS. Water­ soluble packaging provides both dermal and inhalation protection and is reflected in the risk assessment for mixing/ loading liquid formulations under the columns for engineering controls with inhalation protection ( i. e. , engineering control inhalation) . Handlers handling a product while it is enclosed in intact water­ soluble packets are permitted to wear the reduced PPE described above, as long as 12 the full required PPE is immediately available. C Mechanical Closed Mixing System : Another type of closed system for liquid formulations is a mechanical system operated by the users that consists of a probe that is inserted into the pesticide container ( either by puncturing the container or through the container' s opening) and seals tightly to the pesticide container to prevent leaks. A transfer pump may be used to move the pesticide from its original container to the sprayer tank or the closed­ system equipment may be connected to the pressure system of the sprayer itself. Some type of metering device is used to measure the quantity of pesticide being transferred. This type of system provides both dermal and respiratory protection and is reflected in the risk assessment for mixing/ loading liquid formulations under the columns for engineering controls with inhalation protection ( i. e. , engineering control inhalation) . Handlers using this closed system are permitted to wear reduced PPE describe above, as long as the full required PPE is immediately available. NOTE: If the closed mixing system does not automatically rinse the container for return to the tank, a handler wearing full PPE must rinse the container and add the rinsate to the spray tank. C Mechanical Transfer System : A mechanical transfer system usually does not meet the definition of a closed system under the WPS, unless inhalation exposure is not a concern. A Mechanical Transfer System is designed by the manufacturer to transfer liquid pesticide in a manner that prevents the liquid ( but not necessarily any vapor) from contacting handlers or other people during the transfer. Often the systems are equipped with dry­ disconnect fittings. However, a probe and pump system without dry­ disconnect fittings also is a mechanical transfer system. This type of system provides both dermal and respiratory protection and is reflected in the risk assessment for mixing/ loading liquid formulations under the columns for engineering controls with no inhalation protection ( i. e. , baseline inhalation) . If inhalation is not a concern for mixers and loaders, the Agency may determine that a mechanical transfer system ( particularly coupled with a dry­ disconnect system ­ ­ see below) , when functioning correctly and used and maintained in accordance with the manufacturer' s written operating instructions, qualifies as a closed system and permit handlers using this system to wear reduced PPE described above, as long as the full required PPE is immediately available. C Dry­ Disconnect System : A dry­ disconnect systems does not meet the definition of a closed system under the WPS unless it is part of a mechanical closed system. Dry­ disconnect systems are fittings designed by the manufacturer to minimize pesticide leakage at each hose disconnect point. These systems are often used in conjunction with mechanical transfer systems. Dry­ disconnect systems greatly reduce leakage of liquid when connecting pipes or hoses are uncoupled from equipment or from other pipes or hoses. 13 Closed Loading Systems for Granular Formulations . Currently, the only engineering control for loading granular formulations are proprietary systems with proprietary names, such as LockNLoad or Smartbox. These closed systems are a type of packaging system where the granular pesticide is packaged by the registrant into specially designed containers that fit onto specific application equipment. When used correctly, these granular packaging systems qualify as a closed loading system under the WPS. Such packaging systems provides both dermal and inhalation protection and are reflected in the risk assessment for loading granular formulations into tractor­ drawn spreader equipment under the columns for engineering controls with inhalation protection ( i. e. , engineering control inhalation) . Handlers handling a granulars in these special packing systems are permitted to wear the reduced PPE described above, as long as the full required PPE is immediately available. NOTE: currently, the Agency is unaware of any closed systems for granular formulations that are compatible with aerial application equipment. However, EPA believes that such systems are feasible and reflected them in the disulfoton risk assessment to promote the development of closed systems for loading granular formulations into aerial equipment. When developed, such packaging systems are expected to provide both dermal and inhalation protection and are reflected in the risk assessment for loading granular formulations into aerial equipment under the columns for engineering controls with inhalation protection ( i. e. , engineering control inhalation) . Engineering Controls for Application Enclosed Cockpits for Aerial Application . The engineering control available for applying pesticides in aerial equipment is an enclosed cockpit. The Agency assumes that an enclosed cockpit provides dermal and inhalation protection and it is reflected in the risk assessment for aerial application under the columns for engineering controls with inhalation protection ( i. e. , engineering control inhalation) . In the Worker Protection Standard for Agricultural Pesticides ( WPS) ­ ­ 40 CFR Parts 156 and 170, applicators in an enclosed cockpit need not wear all the PPE listed on the pesticide labeling, but must wear at least: long­ sleeved shirt, and long pants, shoes, and socks. In addition, such applicators must ( 1) wear chemical­ resistant gloves when entering or leaving an aircraft contaminated by pesticide residues, and ( 2) store used gloves in a closed, chemical­ resistant container, such as a plastic bag, to prevent contamination of the inside of the cockpit. Enclosed Cabs for Motorized Ground Application. The engineering control available for applying pesticides in motorized ground equipment is an enclosed cab. In the Worker Protection Standard for Agricultural Pesticides ( WPS) ­ ­ 40 CFR Parts 156 and 170, an enclosed cab must have a nonporous barrier that totally surrounds the occupants and prevents contact with pesticides outside of the cab. If inhalation is not a concern for ground applicators ( i. e. , no inhalation protection is required) , any enclosed cab that surrounds occupants with a nonporous barrier meets the definition of enclosed cab. Enclosed cabs that provide dermal protection only are reflected in the risk assessment for ground equipment application ( i. e. , groundboom and tractor­ drawn spreader) under the columns for engineering controls with no inhalation protection ( i. e. , baseline inhalation) . If the risks with no inhalation protection are of concern, then the occupants of the enclosed cabs must either wear the appropriate type of respirator or use an enclosed cab that provides the appropriate level of respiratory protection. The risks for such 14 situations are reflected in the risk assessment for ground equipment application under the columns for engineering controls with inhalation protection ( i. e. , engineering control inhalation) . Some enclosed­ cab systems provide respiratory protection equivalent to a dust/ mist filtering respirator and could, therefore, be used as a substitute when that type of respirator is specified on the product labeling. Other enclosed­ cab systems are equipped to remove organic vapors as well as dusts and mists and could be used as a substitute when either the dust/ mist filtering respirator or an organic­ vapor­ removing respirator is specified on the product labeling. Enclosed cabs that provide respiratory protection must have a properly functioning ventilation system that is used and maintained according to the manufacturer' s written operating instructions. The cab must be declared in writing by the manufacturer or by a governmental agency to provide at least as much respiratory protection as the type of respirator listed on the pesticide labeling. NOTE: Occupants of enclosed cabs need not wear all the PPE listed on the pesticide labeling, but must wear at least: long­ sleeved shirt and long pants, shoes and socks. They must also wear a respirator inside the enclosed cab if a respirator is listed on the labeling for ground equipment applicators, unless the enclosed cab provides respiratory protection equivalent to the type of respirator required. In any enclosed cab where reduced PPE is worn, handlers must: ( 1) keep immediately available all PPE listed on the labeling for the type of task being performed, ( 2) wear the PPE if it is necessary to leave the cab and contact pesticide­ treated surfaces in the treated area, ( 3) take off PPE that was worn in the treated area before reentering the cab, and ( 4) store all PPE in a chemical­ resistant container, such as a plastic bag, to prevent contamination of the inside of the cab. Engineering Controls for Flagging The engineering controls available for flagging to support aerial applications is enclosed cabs and mechanical or remote flaggers. The enclosed cab engineering control is the same as the enclosed cab described under Enclosed Cabs for Motorized Ground Application . By definition, mechanical flaggers and other remote flagging devices do not result in significant exposures to humans. 15 TABLE 3: SUMMARY OF HANDLER RISKS FOR DISULFOTON BY CROP Crop Handler Scenario Application Rate / Area Treated a, b Baseline Total MOE c ( UF= 100) PPE ( Gloves) Total MOE c ( UF= 100) PPE ( Gloves + Double Layers) Total MOE c ( UF= 100) Engineering Controls Total MOE c ( UF= 100) Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T No R Resp No R Resp No R Resp No R Resp No I Inh No I Inh Tobacco Mixing/ loading liquid formulation for aerial application 4 lb/ A & 350 A 0. 0086 0. 0014 0. 69 0. 97 0. 17 0. 18 0. 82 1. 3 0. 22 0. 24 1. 1 2. 6 0. 39 0. 4 8 Applying sprays with aircraft ND ND ND ND ND ND ND ND ND ND NF 4.3 NF 0. 8 1 Flagging for aerial spray applications 1. 7 0. 36 N \ A N \ A N \ A N \ A 1. 8 NG 2. 3 NG 0. 39 NG 0. 41 NG 6. 1 84 4. 8 18 Loading granular formulations for aerial application 4 lb/ A & 350 A 0. 92 0. 36 0. 97 2. 3 0. 41 0. 55 1. 1 3. 5 0. 64 1 NF 46 NF 18 Applying granules with aircraft ND ND ND ND ND ND ND ND ND ND NF 1.5 NF 1 Flagging for aerial granular applications 5.6 1. 4 N \ A N \ A N \ A N \ A 7. 7 NG 13 NG 2. 2 NG 2. 5 NG 15 280 12 68 Mixing/ loading liquid formulation for groundboom application 4 lb/ A & 80 A 0. 038 0. 0063 3 4. 3 0. 72 0. 78 3. 6 5. 6 0. 95 1 5 11 1. 7 2. 1 Applying sprays with groundboom equipment 4. 9 1. 2 4. 9 7 1. 2 1. 3 5. 7 8. 6 1. 5 1. 6 8. 3 20 2. 9 3. 6 Loading granular formulations for ground application 4 lb/ A & 80 A 4 1. 6 4. 2 10 1. 8 2. 4 4. 9 15 2. 8 4. 5 NF 200 NF 78 Applying granules with tractor­ drawn spreader 4. 7 1. 5 5. 3 11 1. 9 2. 4 6. 2 16 2. 8 3. 9 7. 1 24 4. 2 7. 3 Asparagus ( SLN) Mixing/ loading liquid formulation for aerial application 1 lb/ A & 350 0. 034 0. 0057 2. 8 3. 9 0. 66 0. 71 3. 3 5. 1 0. 87 0. 96 4. 6 11 1. 5 1. 9 Applying sprays with aircraft ND ND ND ND ND ND ND ND ND ND NF 17 NF 3.3 Flagging for aerial spray applications 6. 7 1. 4 N \ A N \ A N \ A N \ A 7. 2 NG 9. 3 NG 1. 6 NG 1. 6 NG 24 340 19 72 Mixing/ loading liquid formulation for groundboom application 1 lb/ A & 80 0. 15 0. 025 12 17 2. 9 3. 1 14 22 3. 8 4. 2 20 46 6. 7 8. 3 Applying sprays with groundboom equipment 20 4. 7 20 28 4. 7 5. 1 23 35 5. 9 6. 5 33 80 11 14 Barley Mixing/ loading liquid formulation for aerial application 1 lb/ A & 1200 A 0. 01 0. 0017 0. 8 1. 1 0. 19 0. 21 0. 96 1. 5 0. 25 0. 28 1. 3 3. 1 0. 45 0. 5 6 Applying sprays with aircraft ND ND ND ND ND ND ND ND ND ND NF 5.1 NF 0. 9 5 Flagging for aerial spray applications 1 lb/ A & 1200 A 2 0. 42 N \ A N \ A N \ A N \ A 2. 1 NG 2. 7 NG 0. 46 NG 0. 48 NG 7. 1 98 5. 6 21 16 TABLE 3: SUMMARY OF HANDLER RISKS FOR DISULFOTON BY CROP continued Crop Handler Scenario Application Rate / Area Treated a, b Baseline Total MOE c ( UF= 100) PPE ( Gloves) Total MOE c ( UF= 100) PPE ( Gloves + Double Layers) Total MOE c ( UF= 100) Engineering Controls Total MOE c ( UF= 100) Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T No R Resp No R Resp No R Resp No R Resp No I Inh No I Inh 1 lb/ A & 350 A 6. 7 1. 4 N \ A N \ A N \ A N \ A 7. 2 NG 9. 3 NG 1. 6 NG 1. 6 NG 24 340 19 72 Loading granular formulations for aerial application 1 lb/ A & 1200 A 1. 1 0. 42 1. 1 2. 7 0. 48 0. 65 1. 3 4. 1 0. 74 1. 2 NF 53 NF 21 Applying granules with aircraft ND ND ND ND ND ND ND ND ND ND NF 1.8 NF 1. 2 Flagging for aerial granular applications 1 lb/ A & 1200 A 6. 5 1. 6 N \ A N \ A N \ A N \ A 8. 9 NG 15 NG 2. 6 NG 2. 9 NG 17 330 15 79 1 lb/ A & 350 A 5. 6 1. 4 N \ A N \ A N \ A N \ A 7. 7 NG 13 NG 2. 2 NG 2. 5 NG 15 280 12 22 Mixing/ loading liquid formulation for groundboom application 1 lb/ A & 200 A 0. 06 0. 01 5. 8 8. 9 1. 2 1. 2 4. 8 6. 8 1. 5 1. 7 8 18 2. 7 3. 3 Applying sprays with groundboom equipment 7. 9 1. 9 7. 9 11 1. 9 2 9. 1 14 2. 4 2. 6 13 32 4. 6 5. 7 Loading granular formulations for ground application 1 lb/ A & 200 A 6. 4 2. 5 6. 8 16 2. 9 3. 9 7. 9 24 4. 5 7. 2 NF 320 NF 130 Applying granules with tractor­ drawn spreader 7. 5 2. 4 8. 5 18 3. 1 3. 8 10 25 4. 5 6. 3 11 39 6. 7 12 Soybeans Loading granular formulations for ground application 1 lb/ A & 200 A 6. 4 2. 5 6. 8 16 2. 9 3. 9 7. 9 24 4. 5 7. 2 NF 320 NF 120 Applying granules with tractor­ drawn spreader 7. 5 2. 4 8. 5 18 3. 1 3. 8 10 25 4. 5 6. 3 11 39 6. 7 12 Wheat Mixing/ loading liquid formulation for aerial application 0. 75/ A & 1200 A 0. 013 0. 0022 1. 1 1. 5 0. 26 0. 28 1. 3 2 0. 34 0. 37 1. 8 4. 1 0. 6 0. 7 4 Applying sprays with aircraft ND ND ND ND ND ND ND ND ND ND NF 6.8 NF 1. 3 Flagging for aerial spray applications 0. 75/ A & 1200 A 2.6 0. 56 N \ A N \ A N \ A N \ A 2. 8 NG 3. 6 NG 0. 61 NG 0. 64 NG 9. 5 130 7. 5 28 0. 75/ A & 350 A 9 1. 9 N \ A N \ A N \ A N \ A 9. 6 NG 12 NG 2. 1 NG 2. 2 NG 32 450 26 95 Loading granular formulations for aerial application 1 lb/ A & 1200 A 1. 1 0. 42 1. 1 2. 7 0. 48 0. 65 1. 3 4. 1 0. 74 1. 2 NF 53 NF 21 Applying granules with aircraft ND ND ND ND ND ND ND ND ND ND NF 1.8 NF 1. 2 1 lb/ A & 1200 A 6. 5 1. 6 N \ A N \ A N \ A N \ A 8. 9 NG 15 NG 2. 6 NG 2. 9 NG 17 330 15 79 Flagging for aerial granular applications 17 TABLE 3: SUMMARY OF HANDLER RISKS FOR DISULFOTON BY CROP continued Crop Handler Scenario Application Rate / Area Treated a, b Baseline Total MOE c ( UF= 100) PPE ( Gloves) Total MOE c ( UF= 100) PPE ( Gloves + Double Layers) Total MOE c ( UF= 100) Engineering Controls Total MOE c ( UF= 100) Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T No R Resp No R Resp No R Resp No R Resp No I Inh No I Inh 1 lb/ A & 350 A 5. 6 1. 4 N \ A N \ A N \ A N \ A 7. 7 NG 13 NG 2. 2 NG 2. 5 NG 15 280 12 68 Mixing/ loading liquid formulation for groundboom application 1 lb/ A & 200 A 0. 06 0. 01 4. 8 6. 8 1. 2 1. 2 5. 8 8. 9 1. 5 1. 7 8 18 2. 7 3. 3 Applying sprays with groundboom equipment 7. 9 1. 9 7. 9 11 1. 9 2 9. 1 14 2. 4 2. 6 13 32 4. 6 5. 7 Loading granular formulations for ground application 1 lb/ A & 200 A 6. 4 2. 5 6. 8 16 2. 9 3. 9 7. 9 24 4. 5 7. 2 NF 320 NF 130 Applying granules with tractor­ drawn spreader 7. 5 2. 4 8. 5 18 3. 1 3. 8 10 25 4. 5 6. 3 11 39 6. 7 12 Sorghum Mixing/ loading liquid formulation for aerial application 0. 5/ A & 1200 A 0. 02 0. 0033 1. 6 2. 3 0. 39 0. 41 1. 9 3 0. 51 0. 56 2. 7 6. 1 0. 9 1. 1 Applying sprays with aircraft ND ND ND ND ND ND ND ND ND ND NF 10 NF 1.9 Flagging for aerial spray applications 0. 5/ A & 1200 A 3. 9 0. 83 N \ A N \ A N \ A N \ A 4. 2 NG 5. 4 NG 0. 91 NG 0. 96 NG 14 200 11 42 0. 5/ A & 350 A 13 2. 9 N \ A N \ A N \ A N \ A 14 NG 19 NG 3. 1 NG 3. 3 NG 49 670 38 140 Loading granular formulations for aerial application 1 lb/ A & 1200 A 1. 1 0. 42 1. 1 2. 7 0. 48 0. 65 1. 3 4. 1 0. 74 1. 2 NF 53 NF 21 Applying granules with aircraft ND ND ND ND ND ND ND ND ND ND NF 1.8 NF 1. 2 Flagging for aerial granular applications 1 lb/ A & 1200 A 6. 5 1. 6 N \ A N \ A N \ A N \ A 8. 9 NG 15 NG 2. 6 NG 2. 9 NG 17 330 15 79 1 lb/ A & 350 A 22 5. 5 N \ A N \ A N \ A N \ A 31 NG 52 NG 8. 9 NG 10 NG 58 1100 50 270 Mixing/ loading liquid formulation for groundboom application 1 lb/ A & 200 A 0. 06 0. 01 4. 8 6. 8 1. 2 1. 2 5. 8 8. 9 1. 5 1. 7 8 18 2. 7 3. 3 Applying sprays with groundboom equipment 7. 9 1. 9 7. 9 11 1. 9 2 9. 1 14 2. 4 2. 6 13 32 4. 6 5. 7 Loading granular formulations for ground application 1 lb/ A & 200 A 6. 4 2. 5 6. 8 16 2. 9 3. 9 7. 9 24 4. 5 7. 2 NF 320 NF 130 Applying granules with tractor­ drawn spreader 7. 5 2. 4 8. 5 18 3. 1 3. 8 10 25 4. 5 6. 3 11 39 6. 7 12 Potatoes ( foliar) Mixing/ loading liquid formulation for aerial application 0. 5/ lbA & 0. 069 0. 011 5. 5 7. 8 1. 3 1. 4 6. 6 10 1. 7 1. 9 9. 1 21 3. 1 3. 8 350 A 18 TABLE 3: SUMMARY OF HANDLER RISKS FOR DISULFOTON BY CROP continued Crop Handler Scenario Application Rate / Area Treated a, b Baseline Total MOE c ( UF= 100) PPE ( Gloves) Total MOE c ( UF= 100) PPE ( Gloves + Double Layers) Total MOE c ( UF= 100) Engineering Controls Total MOE c ( UF= 100) Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T No R Resp No R Resp No R Resp No R Resp No I Inh No I Inh Applying sprays with aircraft ND ND ND ND ND ND ND ND ND ND NF 35 NF 6.5 Flagging for aerial spray applications 13 2. 9 N \ A N \ A N \ A N \ A 14 NG 19 NG 3. 1 NG 3. 3 NG 49 670 38 140 Mixing/ loading/ applying liquid formulation through chemigation ( OR, WA, ID, UT) 3. 0 lb/ A & 350 A 0. 011 0. 0019 0. 92 1. 3 0. 22 0. 24 1. 1 1. 7 0. 29 0. 32 1. 5 3. 5 0. 51 0. 6 3 Mixing/ loading liquid formulation for groundboom application 0. 5 lb/ A & 80 A 0. 3 0. 05 24 34 5. 8 6. 2 29 44 7. 6 8. 4 40 92 13 17 Applying sprays with groundboom equipment 39 9. 5 39 56 9. 5 10 46 69 12 13 66 160 23 29 Potatoes ( soil­ directed) Mixing/ loading liquid formulation for groundboom application 3 lb/ A & 80 A 0. 05 0. 0084 4 5. 7 0. 96 1 4. 8 7. 4 1. 3 1. 4 6. 6 15 2. 2 2. 8 Applying sprays with groundboom equipment 6. 6 1. 6 6. 6 9. 3 1. 6 1. 7 7. 6 12 2 2. 2 11 27 3. 8 4. 8 Loading granular formulations for aerial application 3 lb/ A & 350 A 1. 2 0. 48 1. 3 3. 1 0. 55 0. 74 1. 5 4. 6 0. 85 1. 4 NF 61 NF 24 Applying granules with aircraft ND ND ND ND ND ND ND ND ND ND NF 2.1 NF 1. 4 Flagging for aerial granular applications 7.5 1. 8 N \ A N \ A N \ A N \ A 10 NG 17 NG 3 NG 3. 4 NG 19 370 17 90 Loading granular formulations for ground application 3 lb/ A & 80 A 5. 3 2. 1 5. 7 14 2. 4 3. 2 6. 5 20 3. 7 6 NF 270 NF 100 Applying granules with tractor­ drawn spreader 6. 3 2 7. 1 15 2. 6 3. 2 8. 3 21 3. 8 5. 2 9. 4 32 5. 6 9. 7 Cotton ( SLN) Mixing/ loading liquid formulation for aerial application 0. 2 lb/ A & 1200 A 0. 05 0. 0084 4 5. 7 0. 96 1 4. 8 7. 4 1. 3 1. 4 6. 6 15 2. 2 2. 8 Applying sprays with aircraft ND ND ND ND ND ND ND ND ND ND NF 25 NF 4.7 Flagging for aerial spray applications 0. 2 lb/ A & 1200 A 34 7. 2 N \ A N \ A N \ A N \ A 36 NG 46 NG 7. 8 NG 8. 2 NG 120 1700 96 360 0. 2 lb/ A & 350 A 9.8 2. 1 N \ A N \ A N \ A N \ A 11 NG 14 NG 2. 3 NG 2. 4 NG 35 490 28 100 Cotton Mixing/ loading/ applying liquid formulation through chemigation 1 lb/ A & 350 A 0. 034 0. 0057 2. 8 3. 9 0. 66 0. 71 3. 3 5. 1 0. 87 0. 96 4. 6 11 1. 5 1. 9 Mixing/ loading liquid formulation for groundboom application 1 lb/ A & 200 A 0. 06 0. 01 4. 8 6. 8 1. 2 1. 2 5. 8 8. 9 1. 5 1. 7 8 18 2. 7 3. 3 19 TABLE 3: SUMMARY OF HANDLER RISKS FOR DISULFOTON BY CROP continued Crop Handler Scenario Application Rate / Area Treated a, b Baseline Total MOE c ( UF= 100) PPE ( Gloves) Total MOE c ( UF= 100) PPE ( Gloves + Double Layers) Total MOE c ( UF= 100) Engineering Controls Total MOE c ( UF= 100) Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T No R Resp No R Resp No R Resp No R Resp No I Inh No I Inh Applying sprays with groundboom equipment 7. 9 1. 9 7. 9 11 1. 9 2 9. 1 14 2. 4 2. 6 13 32 4. 6 5. 7 Loading granular formulations for ground application 1 lb/ A & 200 A 6. 4 2. 5 6. 8 16 2. 9 3. 9 7. 9 24 4. 5 7. 2 NF 320 NF 130 Applying granules with tractor­ drawn spreader 7. 5 2. 4 8. 5 18 3. 1 3. 8 10 25 4. 5 6. 3 11 39 6. 7 12 Poplars Grown for Pulpwood ( SLN) Mixing/ loading/ applying liquid formulation through chemigation 3 lb/ A & 350 A 0. 011 0. 0019 0. 92 1. 3 0. 22 0. 24 1. 1 1. 7 0. 29 0. 32 1. 5 3. 5 0. 51 0. 6 3 Mixing/ loading liquid formulation for groundboom application 3 lb/ A & 80 A 0. 05 0. 0084 4 5. 7 0. 96 1 4. 8 7. 4 1. 3 1. 4 6. 6 15 2. 2 2. 8 Applying sprays with groundboom equipment 6. 6 1. 6 6. 6 9. 3 1. 6 1. 7 7. 6 12 2 2. 2 11 27 3. 8 4. 8 Cabbage Mixing/ loading/ applying liquid formulation through chemigation 2 lb/ A & 350 A 0. 017 0. 0029 1. 4 1. 9 0. 33 0. 36 1. 6 2. 5 0. 43 0. 48 2. 3 5. 3 0. 77 0. 9 5 Mixing/ loading liquid formulation for groundboom application 2 lb/ A & 80 A 0. 075 0. 013 6 8. 5 1. 4 1. 6 7. 2 11 1. 9 2. 1 10 23 3. 4 4. 2 Applying sprays with groundboom equipment 9. 8 2. 4 9. 8 14 2. 4 2. 6 11 17 2. 9 3. 2 17 40 5. 7 7. 2 Loading granular formulations for ground application 1. 5 lb/ A & 80 A 11 4. 2 11 27 4. 8 6. 5 13 41 7. 4 12 NF 530 NF 210 Applying granules with tractor­ drawn spreader 13 4 14 30 5. 2 6. 4 17 42 7. 6 10 19 64 11 19 Lettuce Mixing/ loading/ applying liquid formulation through chemigation 2 lb/ A & 350 A 0. 017 0. 0029 1. 4 1. 9 0. 33 0. 36 1. 6 2. 5 0. 43 0. 48 2. 3 5. 3 0. 77 0. 9 5 Mixing/ loading liquid formulation for groundboom application 2 lb/ A & 80 A 0. 075 0. 013 6 8. 5 1. 4 1. 6 7. 2 11 1. 9 2. 1 10 23 3. 4 4. 2 Applying sprays with groundboom equipment 9. 8 2. 4 9. 8 14 2. 4 2. 6 11 17 2. 9 3. 2 17 40 5. 7 7. 2 Broccoli, Brussels sprouts, cauliflower Mixing/ loading/ applying liquid formulation through chemigation 1 lb/ A & 350 A 0. 034 0. 0057 2. 8 3. 9 0. 66 0. 71 3. 3 5. 1 0. 87 0. 96 4. 6 11 1. 5 1. 9 Mixing/ loading liquid formulation for groundboom application 1 lb/ A & 80 A 0. 15 0. 025 12 17 2. 9 3. 1 14 22 3. 8 4. 2 20 46 6. 7 8. 3 Applying sprays with groundboom equipment 20 4. 7 20 28 4. 7 5. 1 23 35 5. 9 6. 5 33 80 11 14 20 TABLE 3: SUMMARY OF HANDLER RISKS FOR DISULFOTON BY CROP continued Crop Handler Scenario Application Rate / Area Treated a, b Baseline Total MOE c ( UF= 100) PPE ( Gloves) Total MOE c ( UF= 100) PPE ( Gloves + Double Layers) Total MOE c ( UF= 100) Engineering Controls Total MOE c ( UF= 100) Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T No R Resp No R Resp No R Resp No R Resp No I Inh No I Inh Loading granular formulations for ground application 1 lb/ A & 80 A 16 6. 3 17 41 7. 3 9. 7 20 61 11 18 NF 800 NF 310 Applying granules with tractor­ drawn spreader 19 6 21 44 7. 7 9. 5 25 64 11 16 28 96 17 29 Peas, Lentils Mixing/ loading liquid formulation for groundboom application 2. 5 lb/ A & 80 A 0. 06 0. 01 4. 8 6. 8 1. 2 1. 2 5. 8 8. 9 1. 5 1. 7 8 18 2. 7 3. 3 Applying sprays with groundboom equipment 7. 9 1. 9 7. 9 11 1. 9 2 9. 1 14 2. 4 2. 6 13 32 4. 6 5. 7 Loading granular formulations for aerial application 2. 5 lb/ A & 350 A 1. 5 0. 58 1. 6 3. 7 0. 66 0. 89 1. 8 5. 6 1 1. 7 NF 73 NF 29 Applying granules with aircraft ND ND ND ND ND ND ND ND ND ND NF 2.5 NF 1. 6 Flagging for aerial granular applications 9 2. 2 N \ A N \ A N \ A N \ A 12 NG 21 NG 3. 6 NG 4 NG 23 450 20 110 Loading granular formulations for ground application 2. 5 lb/ A & 80 A 6. 4 2. 5 6. 8 16 2. 9 3. 9 7. 9 24 4. 5 7. 2 NF 320 NF 130 Applying granules with tractor­ drawn spreader 7. 5 2. 4 8. 5 18 3. 1 3. 8 10 25 4. 5 6. 3 11 39 6. 7 12 Beans ( dry, snap, lima) Mixing/ loading liquid formulation for groundboom application 2 lb/ A & 80 A 0. 075 0. 013 6 8. 5 1. 4 1. 6 7. 2 11 1. 9 2. 1 10 23 3. 4 4. 2 Applying sprays with groundboom equipment 9. 8 2. 4 9. 8 14 2. 4 2. 6 11 17 2. 9 3. 2 17 40 5. 7 7. 2 Loading granular formulations for ground application 1 lb/ A & 80 A 16 6. 3 17 41 7. 3 9. 7 20 61 11 18 NF 800 NF 310 Applying granules with tractor­ drawn spreader 19 6 21 44 7. 7 9. 5 25 64 11 16 28 96 17 29 Peppers, Radish grown for seed ( SLN) Mixing/ loading liquid formulation for groundboom application 2 lb/ A & 80 A 0. 075 0. 013 6 8. 5 1. 4 1. 6 7. 2 11 1. 9 2. 1 10 23 3. 4 4. 2 Applying sprays with groundboom equipment 9. 8 2. 4 9. 8 14 2. 4 2. 6 11 17 2. 9 3. 2 17 40 5. 7 7. 2 Loading granular formulations for ground application 2 lb/ A & 80 A 8 3. 2 8. 5 20 3. 6 4. 8 9. 8 30 5. 6 9 NF 400 NF 160 Applying granules with tractor­ drawn spreader 9. 4 3 11 22 3. 9 4. 8 12 32 5. 7 7. 8 14 48 8. 4 15 21 TABLE 3: SUMMARY OF HANDLER RISKS FOR DISULFOTON BY CROP continued Crop Handler Scenario Application Rate / Area Treated a, b Baseline Total MOE c ( UF= 100) PPE ( Gloves) Total MOE c ( UF= 100) PPE ( Gloves + Double Layers) Total MOE c ( UF= 100) Engineering Controls Total MOE c ( UF= 100) Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T No R Resp No R Resp No R Resp No R Resp No I Inh No I Inh Peanuts ( SLN) Loading granular formulations for aerial application 2 lb/ A & 350 A 1. 8 0. 72 1. 9 4. 7 0. 83 1. 1 2. 2 7 1. 3 2. 1 NF 91 NF 36 Applying granules with aircraft ND ND ND ND ND ND ND ND ND ND NF 3.1 NF 2 Flagging for aerial granular applications 11 2. 7 N \ A N \ A N \ A N \ A 15 NG 26 NG 4. 4 NG 5 NG 29 560 25 140 Loading granular formulations for ground application 2 lb/ A & 80 A 8 3. 2 8. 5 20 3. 6 4. 8 9. 8 30 5. 6 9 NF 400 NF 160 Applying granules with tractor­ drawn spreader 9. 4 3 11 22 3. 9 4. 8 12 32 5. 7 7. 8 14 48 8. 4 15 Peanuts Loading granular formulations for ground application 1 lb/ A & 80 A 16 6. 3 17 41 7. 3 9. 7 20 61 11 18 NF 800 NF 310 Applying granules with tractor­ drawn spreader 19 6 21 44 7. 7 9. 5 25 64 11 16 28 96 17 29 Clover grown for seed ( SLN) Loading granular formulations for aerial application 1 lb/ A & 350 A 3. 7 1. 4 3. 9 9. 4 1. 7 2. 2 4. 5 14 2. 5 4. 1 NF 180 NF 72 Applying granules with aircraft ND ND ND ND ND ND ND ND ND ND NF 6.2 NF 4. 1 Flagging for aerial granular applications 22 5. 4 N \ A N \ A N \ A N \ A 31 NG 52 NG 8. 9 NG 10 NG 58 1100 50 270 Loading granular formulations for ground application 1 lb/ A & 80 A 16 6. 3 17 41 7. 3 9. 7 20 61 11 18 NF 800 NF 310 Applying granules with tractor­ drawn spreader 19 6 21 44 7. 7 9. 5 25 64 11 16 28 96 17 29 Field Grown Ornamental Shrubs Loading granular formulations for ground application 109 lb/ A & 40 A 0. 29 0. 12 0. 31 0. 75 0. 13 0. 18 0. 36 1. 1 0. 2 0. 33 NF 15 NF 5. 7 Applying granules with tractor­ drawn spreader 0. 35 0. 11 0. 39 0. 81 0. 14 0. 18 0. 46 1. 2 0. 21 0. 29 0. 52 1. 8 0. 31 0. 5 3 Loading/ Applying with Push Type Spreader 109 lb/ A & 5 A 0. 15 0. 029 0. 21 0. 27 0. 046 0. 048 0. 33 0. 51 0. 086 0. 095 NF NF NF NF Loading/ Applying with Bellygrinder 109 lb/ A & 1 A 0. 03 0. 0053 0. 032 0. 034 0. 0057 0. 0057 0. 05 0. 055 0. 0092 0. 0094 NF NF NF NF Loading/ Applying with Pump Feed Backpack Spreader 109 lb/ A & 10 A ND ND 0. 57 AP 1. 7 AP 0. 3 AP 0. 46 AP ND ND ND ND NF NF NF NF 109 lb/ A & 5 A ND ND 1. 1 AP 3. 3 AP 0. 6 AP 0. 93 AP ND ND ND ND NF NF NF NF Loading/ Applying with Gravity Feed Backpack Spreader 109 lb/ A & 10 A ND ND 0. 029 0. 046 0. 0079 0. 0087 ND ND ND ND NF NF NF NF 109 lb/ A & 5 A ND ND 0. 059 0. 092 0. 016 0. 017 ND ND ND ND NF NF NF NF 22 TABLE 3: SUMMARY OF HANDLER RISKS FOR DISULFOTON BY CROP continued Crop Handler Scenario Application Rate / Area Treated a, b Baseline Total MOE c ( UF= 100) PPE ( Gloves) Total MOE c ( UF= 100) PPE ( Gloves + Double Layers) Total MOE c ( UF= 100) Engineering Controls Total MOE c ( UF= 100) Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T No R Resp No R Resp No R Resp No R Resp No I Inh No I Inh Loading/ Applying with Scoop and Bucket 109 lb/ A & 10 A ND ND 0. 013 0. 015 0. 0026 0. 0027 ND ND ND ND NF NF NF NF 109 lb/ A & 5 A ND ND 0. 026 0. 031 0. 0051 0. 0053 ND ND ND ND NF NF NF NF Field Grown Ornamental Trees Loading granular formulations for ground application 37 lb/ A & 40 A 0. 87 0. 34 0. 92 2. 2 0. 39 0. 52 1. 1 3. 3 0. 6 0. 98 NF 43 NF 17 Applying granules with tractor­ drawn spreader 1 0. 33 1. 2 2. 4 0. 42 0. 52 1. 3 3. 4 0. 61 0. 85 1. 5 5. 2 0. 91 1. 6 Loading/ Applying with Push Type Spreader 37 lb/ A & 5 A 0. 44 0. 087 0. 62 0. 8 0. 13 0. 14 0. 98 1. 5 0. 25 0. 28 NF NF NF NF Loading/ Applying with Bellygrinder 37 lb/ A & 1 A 0. 088 0. 016 0. 095 0. 1 0. 017 0. 017 0. 15 0. 16 0. 027 0. 028 NF NF NF NF Loading/ Applying with Pump Feed Backpack Spreader 37 lb/ A & 10 A ND ND 1. 7 AP 4.9 AP 0.89 AP 1.4 AP ND ND ND ND NF NF NF NF 37 lb/ A & 5 A ND ND 3. 3 AP 9.8 AP 1.8 AP 2.7 AP ND ND ND ND NF NF NF NF Loading/ Applying with Gravity Feed Backpack Spreader 37 lb/ A & 10 A ND ND 0. 087 0. 14 0. 023 0. 026 ND ND ND ND NF NF NF NF 37 lb/ A & 5 A ND ND 0. 17 0. 27 0. 046 0.051 ND ND ND ND NF NF NF NF Loading/ Applying with Scoop and Bucket 37 lb/ A & 10 A ND ND 0. 038 0. 045 0. 0076 0. 0078 ND ND ND ND NF NF NF NF 37 lb/ A & 5 A ND ND 0. 076 0. 09 0. 015 0. 016 ND ND ND ND NF NF NF NF Field Grown Ornamental Flowers and Groundcover Loading granular formulations for ground application 29 lb/ A & 40 A 1. 1 0. 44 1. 2 2. 8 0. 5 0. 67 1. 4 4. 2 0. 77 1. 2 NF 55 NF 22 Applying granules with tractor­ drawn spreader 1. 3 0. 41 1. 5 3. 1 0. 53 0. 66 1. 7 4. 4 0. 78 1. 1 2 6. 6 1. 2 2 Loading/ Applying with Push Type Spreader 29 lb/ A & 5 A 0. 56 0. 11 0. 8 1 0. 17 0. 18 1. 2 1. 9 0. 32 0. 36 NF NF NF NF Loading/ Applying with Bellygrinder 29 lb/ A & 1 A 0. 11 0. 02 0. 12 0. 13 0. 021 0. 022 0. 19 0. 21 0. 035 0. 035 NF NF NF NF Loading/ Applying with Pump Feed Backpack Spreader 29 lb/ A & 10 A ND ND 2. 1 AP 6.2 AP 1.1 AP 1.7 AP ND ND ND ND NF NF NF NF 29 lb/ A & 5 A ND ND 4. 3 AP 12 AP 2.3 AP 3.5 AP ND ND ND ND NF NF NF NF Loading/ Applying with Gravity Feed Backpack Spreader 29 lb/ A & 10 A ND ND 0. 11 0. 17 0. 03 0. 033 ND ND ND ND NF NF NF NF 29 lb/ A & 5 A ND ND 0. 22 0. 35 0. 059 0.065 ND ND ND ND NF NF NF NF Loading/ Applying with Scoop and Bucket 29 lb/ A & 10 A ND ND 0. 048 0. 057 0. 0097 0. 01 ND ND ND ND NF NF NF NF 29 lb/ A & 5 A ND ND 0. 097 0. 11 0. 019 0. 02 ND ND ND ND NF NF NF NF Field Grown Flowers & Groundcover ( lower rate) Loading granular formulations for ground application 11 lb/ A & 40 A 2. 9 1. 1 3. 1 7. 4 1. 3 1. 8 3. 6 11 2 3. 3 NF 150 NF 57 Applying granules with tractor­ drawn spreader 3. 4 1. 1 3. 9 8. 1 1. 4 1. 7 4. 5 12 2. 1 2. 9 5. 2 18 3. 1 5. 3 23 TABLE 3: SUMMARY OF HANDLER RISKS FOR DISULFOTON BY CROP continued Crop Handler Scenario Application Rate / Area Treated a, b Baseline Total MOE c ( UF= 100) PPE ( Gloves) Total MOE c ( UF= 100) PPE ( Gloves + Double Layers) Total MOE c ( UF= 100) Engineering Controls Total MOE c ( UF= 100) Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T No R Resp No R Resp No R Resp No R Resp No I Inh No I Inh Loading/ Applying with Push Type Spreader 11 lb/ A & 5 A 1. 5 0. 29 2. 1 2. 7 0. 45 0. 48 3. 3 5 0. 86 0. 94 NF NF NF NF Loading/ Applying with Bellygrinder 11 lb/ A & 1 A 0. 3 0. 052 0. 32 0. 34 0. 056 0. 057 0. 5 0. 55 0. 091 0. 093 NF NF NF NF Loading/ Applying with Pump Feed Backpack Spreader 11 lb/ A & 10 A ND ND 5. 6 AP 16 AP 3 AP 4.6 AP ND ND ND ND NF NF NF NF 11 lb/ A & 5 A ND ND 11 AP 33 AP 6 AP 9.2 AP ND ND ND ND NF NF NF NF Loading/ Applying with Gravity Feed Backpack Spreader 11 lb/ A & 10 A ND ND 0. 29 0. 46 0. 078 0.086 ND ND ND ND NF NF NF NF 11 lb/ A & 5 A ND ND 0. 58 0. 91 0. 16 0. 17 ND ND ND ND NF NF NF NF Loading/ Applying with Scoop and Bucket 11 lb/ A & 10 A ND ND 0. 13 0. 15 0. 025 0.026 ND ND ND ND NF NF NF NF 11 lb/ A & 5 A ND ND 0. 25 0. 3 0.051 0.053 ND ND ND ND NF NF NF NF Field Grown Ornamental Trees & Shrubs ( Injection) Loading granular formulations for ground application 11 lb/ A & 40 A 2. 9 1. 1 3. 1 7. 4 1. 3 1. 8 3. 6 11 2 3. 3 NF 150 NF 57 Applying granules with tractor­ drawn spreader 3. 4 1. 1 3. 9 8. 1 1. 4 1. 7 4. 5 12 2. 1 2. 9 5. 2 18 3. 1 5. 3 Loading/ Applying with Push Type Spreader 11 lb/ A & 5 A 1. 5 0. 29 2. 1 2. 7 0. 45 0. 48 3. 3 5 0. 86 0. 94 NF NF NF NF Loading/ Applying with Bellygrinder 11 lb/ A & 1 A 0. 3 0. 052 0. 32 0. 34 0. 056 0. 057 0. 5 0. 55 0. 091 0. 093 NF NF NF NF Loading/ Applying with Pump Feed Backpack Spreader 11 lb/ A & 10 A ND ND 5. 6 AP 16 AP 3 AP 4.6 AP ND ND ND ND NF NF NF NF 11 lb/ A & 5 A ND ND 11 AP 33 AP 6 AP 9.2 AP ND ND ND ND NF NF NF NF Loading/ Applying with Gravity Feed Backpack Spreader 11 lb/ A & 10 A ND ND 0. 29 0. 46 0. 078 0.086 ND ND ND ND NF NF NF NF 11 lb/ A & 5 A ND ND 0. 58 0. 91 0. 16 0. 17 ND ND ND ND NF NF NF NF Loading/ Applying with Scoop and Bucket 11 lb/ A & 10 A ND ND 0. 13 0. 15 0. 025 0.026 ND ND ND ND NF NF NF NF 11 lb/ A & 5 A ND ND 0. 25 0. 3 0.051 0.053 ND ND ND ND NF NF NF NF Potted Ornamentals Loading/ Applying with Pump Feed Backpack Spreader 0.2 lb ai/ day ND ND 3100 AP 9100 AP 1600 AP 2500 AP ND ND ND ND NF NF NF NF Loading/ Applying with Gravity Feed Backpack Spreader ND ND 160 250 43 47 ND ND ND ND NF NF NF NF Loading/ Applying with Scoop and Bucket ND ND 70 83 14 14 ND ND ND ND NF NF NF NF Chrismas Trees Loading granular formulations for ground application 78 lb/ A & 50 A 0. 33 0. 13 0. 35 0. 84 0. 15 0. 2 0. 4 1. 3 0. 23 0. 37 NF 16 NF 6. 4 Applying granules with tractor­ drawn spreader 0. 39 0. 12 0. 44 0. 91 0. 16 0. 2 0. 51 1. 3 0. 23 0. 32 0. 58 2 0. 35 0. 6 24 TABLE 3: SUMMARY OF HANDLER RISKS FOR DISULFOTON BY CROP continued Crop Handler Scenario Application Rate / Area Treated a, b Baseline Total MOE c ( UF= 100) PPE ( Gloves) Total MOE c ( UF= 100) PPE ( Gloves + Double Layers) Total MOE c ( UF= 100) Engineering Controls Total MOE c ( UF= 100) Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T No R Resp No R Resp No R Resp No R Resp No I Inh No I Inh Loading/ Applying with Push Type Spreader 78 lb/ A & 5 A 0. 21 0. 041 0. 3 0. 38 0. 064 0. 067 0. 46 0. 71 0. 12 0. 13 NF NF NF NF Loading/ Applying with Bellygrinder 78 lb/ A & 1 A 0. 042 0. 0074 0. 045 0. 048 0. 0079 0. 008 0. 07 0. 077 0. 013 0. 013 NF NF NF NF Loading/ Applying with Pump Feed Backpack Spreader 78 lb/ A & 10 A ND ND 0. 79 AP 2.3 AP 0.42 AP 0.65 AP ND ND ND ND NF NF NF NF 78 lb/ A & 5 A ND ND 1. 6 AP 4.6 AP 0.84 AP 1.3 AP ND ND ND ND NF NF NF NF Loading/ Applying with Gravity Feed Backpack Spreader 78 lb/ A & 10 A ND ND 0. 041 0. 064 0. 011 0. 012 ND ND ND ND NF NF NF NF 78 lb/ A & 5 A ND ND 0. 082 0. 13 0. 022 0. 024 ND ND ND ND NF NF NF NF Loading/ Applying with Scoop and Bucket 78 lb/ A & 10 A ND ND 0. 018 0. 021 0. 0036 0. 0037 ND ND ND ND NF NF NF NF 78 lb/ A & 5 A ND ND 0. 036 0. 043 0. 0072 0. 0074 ND ND ND ND NF NF NF NF Christmas Trees ( SLN) Loading granular formulations for ground application 4. 5 lb/ A & 50 A 5. 7 2. 2 6 15 2. 6 3. 4 7 22 4 6. 4 NF 280 NF 110 Applying granules with tractor­ drawn spreader 6. 7 2. 1 7. 6 16 2. 8 3. 4 8. 9 23 4 5. 6 10 34 6 10 Loading/ Applying with Push Type Spreader 4. 5 lb/ A & 5 A 3. 6 0. 71 5. 1 6. 6 1. 1 1. 2 8 12 2. 1 2. 3 NF NF NF NF Loading/ Applying with Bellygrinder 4. 5 lb/ A & 1 A 0. 73 0. 13 0. 78 0. 82 0. 14 0. 14 1. 2 1. 3 0. 22 0. 23 NF NF NF NF Loading/ Applying with Pump Feed Backpack Spreader 4.5 lb/ A & 10 A ND ND 14 AP 40 AP 7.3 AP 11 AP ND ND ND ND NF NF NF NF 4.5 lb/ A & 5 A ND ND 27 AP 80 AP 15 AP 22 AP ND ND ND ND NF NF NF NF Loading/ Applying with Gravity Feed Backpack Spreader 4.5 lb/ A & 10 A ND ND 0. 71 1. 1 0.19 0.21 ND ND ND ND NF NF NF NF 4. 5 lb/ A & 5 A ND ND 1. 4 2. 2 0. 38 0. 42 ND ND ND ND NF NF NF NF Loading/ Applying with Scoop and Bucket 4.5 lb/ A & 10 A ND ND 0. 31 0. 37 0. 062 0.064 ND ND ND ND NF NF NF NF 4. 5 lb/ A & 5 A ND ND 0. 62 0. 74 0. 12 0. 13 ND ND ND ND NF NF NF NF Coffee Trees Loading granular formulations for ground application 8. 3 lb/ A & 80 A 1. 9 0. 76 2 4. 9 0. 87 1. 2 2. 4 7. 3 1. 3 2. 2 NF 96 NF 38 Applying granules with tractor­ drawn spreader 2. 3 0. 72 2. 6 5. 3 0. 93 1. 1 3 7. 7 1. 4 1. 9 3. 4 12 2 3. 5 Loading/ Applying with Pump Feed Backpack Spreader 8.3 lb/ A & 10 A ND ND 7. 4 AP 22 AP 4 AP 6.1 AP ND ND ND ND NF NF NF NF 8. . 3 lb/ A & 5 A ND ND 15 AP 44 AP 7.9 AP 12 AP ND ND ND ND NF NF NF NF Loading/ Applying with Gravity Feed Backpack Spreader 8. 3 lb/ A & 10 A ND ND 0. 39 0. 6 0. 1 0. 11 ND ND ND ND NF NF NF NF 8.3 lb/ A & 5 A ND ND 0. 77 1. 2 0.21 0.23 ND ND ND ND NF NF NF NF Loading/ Applying with Scoop and 8. 3 lb/ A & 10 A ND ND 0. 17 0. 2 0. 034 0. 035 ND ND ND ND NF NF NF NF Bucket 25 TABLE 3: SUMMARY OF HANDLER RISKS FOR DISULFOTON BY CROP continued Crop Handler Scenario Application Rate / Area Treated a, b Baseline Total MOE c ( UF= 100) PPE ( Gloves) Total MOE c ( UF= 100) PPE ( Gloves + Double Layers) Total MOE c ( UF= 100) Engineering Controls Total MOE c ( UF= 100) Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T Short­ T Inter. ­ T No R Resp No R Resp No R Resp No R Resp No I Inh No I Inh 8.3 lb/ A & 5 A ND ND 0. 34 0. 4 0.067 0.07 ND ND ND ND NF NF NF NF Note : Short­ T indicates short­ term exposure and risk Inter­ T indicates intermediate­ term exposure and risk No R indicates no respirator Resp indicates use of a dust/ mist respirator No I indicates no inhalation protection was provided by the engineering control Inh indicates that inhalation protection was provided by the engineering control AP indicates that an apron was worn on the backs of applicators. ND indicates no data an exposure scenario was identified, , but there are no acceptable data to complete assessment. NF indicates that no engineering controls are feasible for this exposure scenario. NG indicates no gloves were added for this scenario. N/ A indicates that the personal protective equipment are not applicable or not appropriate for this scenario. Footnotes: a Application rates are based on maximum values found on various labels or proposed by registrant. In most scenarios, a range of maximum application rates is used to represent the range of rates for different crops/ sites/ uses. Most application rates upon which the analysis is based are presented as lb ai/ A. In the case of ornamentals in pots, the application rate is presented as lb ai/ day) . Specific application rates and the corresponding EPA Reg. numbers that are intended as examples of each exposure assessment scenario are presented below: 4.0 lb/ A EC formulations: tobacco ( Reg # 3125­ 307) 3. 0 lb/ A EC formulations: potatoes: foliar OR, WA, ID UT ( Reg # 3125­ 307) ; potatoes: soil ( Reg # 3125­ 307) ; poplars grown for pulpwood ( Reg # 3125­ 307­ ­ OR­ 910027) 2.5 lb/ A EC formulations: peas and lentils ( Reg # 3125­ 307) 2. 0 lb/ A EC formulations: beans: dry, snap, lima ( Reg # 3125­ 307) ; cabbage ( Reg # 3125­ 307) ; lettuce ( Reg # 3125­ 307) ; peppers ( Reg # 3125­ 307) ; radish grown for seed ( Reg # 3125­ 307­ WA­ 920026) ; 1. 0 lb/ A EC formulations: asparagus ( SLN) ( Reg # 3125­ 307­ CA­ 840192) ; barley ( Reg # 3125­ 307) ; broccoli ( Reg # 3125­ 307) ; Brussels sprouts ( Reg # 3125­ 307) ; cauliflower ( Reg # 3125­ 307) ; cotton ( Reg # 3125­ 307) ; sorghum ( Reg # 3125­ 307) ; wheat ( Reg # 3125­ 307) ; 0. 75 lb/ A EC formulations: wheat ( Reg # 3125­ 307) 0. 5 lb/ A EC formulations: sorghum ( Reg # 3125­ 307) ; potatoes: foliar ( Reg # 3125­ 307) 0. 2 lb/ A EC formulations: cotton ( ( Reg # 3125­ 307­ TX­ 860007) 109 lb/ A Granular formulations: field­ grown ornamental shrubs ( Reg # 3125­ 172) based on the assumption that the shrubs are two feet tall and occupy two square feet ( i. e. , roses) ; 78 lb/ A Granular formulations: Christmas trees ( Reg # 3125­ 172) based on the assumption that the trunk is 2 inches in diameter and are planted 1700 trees per acre; 37 lb/ A Granular formulations: field­ grown ornamental trees ( Reg # 3125­ 172) based on the assumption that the trunk is 2 inches in diameters and are planted 800 trees per acre; 29 lb/ A Granular formulations: field­ grown flowers and groundcover ( Reg # 3125­ 72) 11 lb/ A Granular formulations: field­ grown ornamental trees and shrubs: injection ( Reg # 3125­ 172) and field­ grown flowers and groundcover ( Reg # 3125­ 72) 8. 3 lb/ A Granular formulations: coffee trees ( Reg # 3125­ 172) based on the assumption that the trees are 8 feet tall and are planted 435 trees per acre 4. 5 lb/ A Granular formulations: Christmas trees ( ( Reg # 3125­ 172­ NC­ 880001) 4.0 lb/ A Granular formulations: tobacco ( Reg # 3125­ 172) ; 3. 0 lb/ A Granular formulations: potatoes: soil ( Reg # 3125­ 172) ; 2.5 lb/ A Granular formulations: peas and lentils ( Reg # 3125­ 172) ; 2. 0 lb/ A Granular formulations: peanuts ( Reg # 3125­ 172­ NC­ 920011) ; peppers ( Reg # 3125­ 172) ; radish grown for seed ( ( Reg # 3125­ 172­ WA­ 920027) ; 1. 5 lb/ A Granular formulations: cabbage ( Reg # 3125­ 172) ; 1. 0 lb/ A Granular formulations: barley ( Reg # 3125­ 172) ; beans: dry, snap, lima: ( Reg # 3125­ 172) ; broccoli ( Reg # 3125­ 172) ; Brussels sprouts ( Reg # 3125­ 172) ; cauliflower 26 TABLE 3: SUMMARY OF HANDLER RISKS FOR DISULFOTON BY CROP continued ( Reg # 3125­ 172) ; clover grown for seed ( Reg # 3125­ 172­ WA­ 980004) ; cotton ( Reg # 3125­ 172) ; peanuts ( Reg # 3125­ 172) ; sorghum ( Reg # 3125­ 172) ; soybeans ( Reg # 3125­ 172) ; wheat ( Reg # 3125­ 172) ; 0. 2 lb/ day Granular formulations: potted ornamentals ( Reg # 3125­ 172) ; based on the assumption that 350 pots that are 12 inches in diameter are treated each day; b Amount handled per day values are based on HED Exposure SAC Policy # 009 Standard Values for Daily Acres Treated in Agriculture, revised June 23, 2000, or best professional judgment when data is not available. 27 Summary of Concerns for Occupational Handlers, Data Gaps, and Confidence in Exposure and Risk Estimates EPA established an uncertainty factor of 100 for dermal and inhalation risks. Margins of exposure ( MOEs) less than 100 are of concern to the Agency. Both short­ and intermediate­ term risks are assessed for occupational handlers. Since the short­ term dermal endpoint is based on a 3­ day dermal study, EPA believes that intermediate­ term risks are triggered for most handler scenarios, particularly by commercial ( for­ hire) applicators. Occupational Handler Scenarios with Risk Concerns The results of the risk assessment for occupational handlers indicates that total short­ term risks are of concern at maximum feasible mitigation through personal protective equipment or engineering controls, as applicable, for: mixing/ loading liquid formulations for all crops and scenarios; loading granular formulations for all aerial application scenarios, except applications to clover grown for seed; loading granular formulations for all ground application scenarios where the application rate is greater than 16.5 pounds active ingredient per acre and application is to 40 acres per day and where the application is greater than 8.3 pounds per acre and application is to 80 acres per day; applying sprays or granules aerially; applying sprays with groundboom equipment, except applications where the application rate is 0.5 pounds active ingredient per acre and application is to 80 acres per day; applying granules with tractor­ drawn spreaders; loading/ applying with a push type granular spreader for all crops and scenarios; loading/ applying with a bellygrinder granular spreader for all crops and scenarios; loading/ applying with a pump­ feed backpack granular spreader for all crops and scenarios, except applications to potted ornamentals; loading/ applying with a gravity­ feed backpack granular spreader for all crops and scenarios, except applications to potted ornamentals; loading/ applying granular formulation with a scoop and bucket for all crops and scenarios; flagging for aerial applications only when flagging to support aerial spray applications for applications at 4 pounds active ingredient per acre and application is to 350 acres per day. The results of the risk assessment for occupational handlers indicates that total intermediate­ term risks are of concern at maximum feasible mitigation through personal protective equipment or engineering controls, as applicable, for: mixing/ loading liquid formulations for all crops and scenarios; loading granular formulations for all aerial application scenarios, except where the application rate is 1 pound active ingredient per acre and application is to 350 acres per day; 28 loading granular formulations for all ground application scenarios where the application rate is greater than 4.5 pounds active ingredient per acre and application is to 50 acres per day and where the application is greater than 3 pounds per acre when application is to 80 acres per day; applying sprays or granular aerially; applying sprays with groundboom equipment; applying granules with tractor­ drawn spreaders; loading/ applying with a push type granular spreader for all crops and scenarios; loading/ applying with a bellygrinder granular spreader for all crops and scenarios; loading/ applying with a pump­ feed backpack granular spreader for all crops and scenarios; except applications to potted ornamentals; loading/ applying with a gravity­ feed backpack granular spreader for all crops and scenarios; loading/ applying granular formulation with a scoop and bucket for all crops and scenarios; flagging to support aerial spray applications, except where the application rate is 0.5 pound active ingredient per acre and application is to 350 acres per day; flagging to support aerial granular applications, where the application rate is greater than 2.5 pounds active ingredient per acre and application is to 350 acres per day and where the application is greater than 0.5 pounds per acre when application is to 1200 acres per day; Data Quality and Confidence in Assessment Several issues must be considered when interpreting the occupational exposure risk assessment. Confidence in the exposure data is also listed in Appendix 6, as low ( L) , medium ( M) or high ( H) . These include: C Several handler assessments were completed using low quality PHED data due to the lack of a more acceptable data set. C Several generic protection factors were used to calculate handler exposures. These protection factors have not been completely evaluated and accepted by HED. C Factors used to calculate daily exposures to handlers ( e. g. , acres treated per day and potted plants treated per day) are based on the best professional judgement, due to a lack of pertinent use data. 29 Post­ Application Exposures and Risks Occupational Postapplication Exposure Scenarios, Data, and Assumptions HED has determined that there are potential postapplication occupational exposures to individuals entering treated areas: following foliar applications for the purpose of weeding, irrigating, scouting and other non­ harvesting activities associated with low­ growing or immature field crops; following soil­ directed applications for the purpose of weeding, irrigating, scouting, transplanting, harvesting, and pruning of various food, feed, fiber, forestry, and ornamental crops. Data Source Descriptions for Occupational Scenarios Considered Chemical­ specific postapplication exposure data following foliar applications to potatoes have been submitted in support of the reregistration of disulfoton, however HED has found these studies to be unacceptable. 10 In addition to the other concerns about the disulfoton­ specific postapplication study, the Agency found no indication that known disulfoton toxic degradates ( i. e. , disulfoton sulfoxide, disulfoton sulfone, D­ oxygen analog sulfoxide, and D­ oxygen analog sulfone) had been considered in assessing the residues. In lieu of acceptable disulfoton­ specific data, a surrogate rangefinder postapplication exposure assessment was conducted to determine potential occupational postapplication risks from disulfoton. Since EPA believes that the applicable postapplication tasks for the crops with foliar­ directed applications are likely to be of short­ term duration ( i. e. , 1 to 7 days) , the short­ term dermal endpoint of 0.5 mg/ kg/ day was used to assess postapplication risks following foliar applications of disulfoton. An intermediate­ term dermal endpoint of 0.03 mg/ kg/ day ( with a 36 percent dermal absorption value) is also available for disulfoton and would likely be the appropriate endpoint to assess some postapplication risks following soil­ directed applications of disulfoton to some food, feed, fiber, and ornamental crops. However, post­ application risks following soil­ directed applications of disulfoton cannot be evaluated at this time. Occupational Postapplication Exposure and Risk Estimates Foliar applications: For postapplication exposures following applications of disulfoton to foliage, EPA roughly estimated the exposures and risks to postapplication workers and handlers ( scouts) using an assumption that 20 percent of the initial application remained as a dislodgeable residue on foliar surfaces immediately following application and the residue degraded into nontoxic by­ products at a rate of 10 percent per day. Transfer coefficients and activities are derived from the Science Advisory Council for Exposure: Policy Memo # 003.1 " Agricultural Transfer Coefficients, " May 7, 1998 and revised August 7, 2000. The equations used for the calculations are presented below. Dislodgeable foliar residues ( DFRs) were calculated as follows: 30 DFR F g ' AR lb ai xCF F g / cm 2 x F x ( 1 & DR ) t cm 2 A lb ai / A Where: AR = Application rate CF = Conversion factor ( 11.2 ug per cm 2 per lb ai per acre) F = Fraction retained on foliage ( 20 percent) DO = Daily dissipation rate ( 10 percent per day) t = Days after treatment Daily Dermal Doses were calculated as follows: ( DFR ( F g / cm 2 ) xTc ( cm 2 / hr ) xCF 1 mg xED ( hrs / day ) ) Dose ( mg / kg / d ) ' BW ( kg ) 1,000 F g Where: DFR = Dislodgeable foliar residue ( F g/ cm 2 ) Tc = Transfer coefficient for the activity of concern; CF = Conversion factor ( i. e. , 1 mg/ 1,000 F g) ED = Exposure duration; 8 hours worked per day BW = body weight ( 70 kg) MOEs were calculated as follows: MOE ' NOEL ( mg / kg / day ) Dose ( mg / kg / day ) Where: NOAEL = 0.5 mg/ kg/ day Dose = calculated daily dermal dose Soil­ Directed applications: At this time, EPA has no chemical­ specific or surrogate data on which to base a postapplication exposure and risk assessment following soil­ directed applications of disulfoton. EPA is aware that disulfoton degrades under some conditions to byproducts ( i. e. , ( i. e. , disulfoton sulfoxide, disulfoton sulfone, D­ oxygen analog sulfoxide, and D­ oxygen analog sulfone) that may be equally toxic as the parent disulfoton. However, the percent of the parent that degrades to the toxic byproducts is not known nor does EPA know the rate at which the toxic degradates will breakdown to nontoxic byproducts. EPA is aware that disulfoton residues may persist in soils for relatively long periods following application, but no specific data indicating the degradation curve is available. For these reasons, the Agency is 31 concerned about exposures by workers and handlers ( scouts) to disulfoton residues in the soil, particularly when applications rates for some crops and scenarios range to more than 100 pounds active ingredient per acre. EPA believes that contact with treated soil could result in risks of concern to postapplication workers and handlers ( scouts) . To facilitate the assessment of risks postapplication workers following soil­ directed applications of disulfoton, additional data would be necessary. Summary of Postapplication Risks Foliar applications: The uncertainty factor for postapplication risks to disulfoton is 100; . therefore, an MOE of 100 or greater is considered not a concern. Based on the rough estimate of postapplication exposures and risks, assumptions, Table 4 summarizes the occupational postapplication risks following foliar applications of disulfoton. The MOEs are of concern at day one ( i. e. , 24 hours) for all crops, except for foliar applications to cotton at an application rate of 0.2 pounds active ingredient per acre. For the remaining crops, the postapplication day when risks are no longer a concern range from day 13 following application to more than day 30 following application, depending on the application rate, the timing of application, and the applicable activity. 32 Table 4: Summary of Occupational PostApplication Risks Following Foliar Applications of Disulfoton Crop Application Rate Tasks of Concern 1 Timing of Application Transfer Coefficient 1 Day After Treatment Dislodgeable Foliar Residue 2 Dose 3 MOE 4 ( UF= 100) Asparagus 1.0 Irrigating, scouting, thinning, weeding immature or low foliage plants fern stage ( 3 per year; 120 DTH) 300 1 2. 019 0.0692 6.5 26 0.145 0.0050 101 Barley 1.0 after tillering ( 30 DTH) 100 1 2. 019 0.0231 20 16 0.416 0.0048 105 Cotton ( SLN) 0.2 Before boll opens ( 30 DTH) 100 1 0. 404 0.0046 108 Potatoes ( East of Rockies) 0.5 When pest appears ( 3 per season; 30 DTH) 300 1 1. 010 0.0346 14 20 0.136 0.0047 107 Potatoes ( OR, ID, UT, WA only) 3.0 As needed ( 1 per season; 60 DTH) 300 1 6. 058 0.2077 2.4 30 0.285 0.0098 51 Sorghum 0.5 scouting, irrigation, weeding mature or full foliage plants As needed ( 2 per season; 7 DTH) 1000 1 1. 01 0. 1154 4.3 30 0.048 0.0054 92 Wheat 0.75 Irrigating, scouting, thinning, weeding immature or low foliage plants Post­ plant ( after tillering; 30 DTH) 100 1 1. 515 0.0173 29 13 0.428 0.0049 102 Wheat ( SLN) 1.0 Two per season ( 30 DTH) 100 1 2. 019 0.0231 20 16 0.416 0.0048 105 Footnotes: 1 Transfer coefficient and activities from Science Advisory Council for Exposure: Policy Memo # 003.1 " Agricultural Transfer Coefficients, " May 7, 1998 and revised August 7, 2000. 2 Dislodgeable foliar residue ( F g/ cm 2 ) is based on the assumption that 20 percent of the application rate is on the foliar surface at day 0 and the active ingredient ( including any toxic degradates) degrades at a rate of 10 percent per day. 3 Absorbed dermal dose ( mg/ kg/ day) is the dislodgeable foliar residue ( F g/ cm 2 ) x transfer coefficient ( cm 2 / hr) x conversion factor ( 1 mg/ 1,000 F g) x exposure time ( 8 hrs) x dermal absorption ( 100% ) / body weight( 70 kg) . 4 Margin of Exposure ( MOE) is short­ term dermal NOAEL ( 0.5 mg/ kg/ day) / absorbed dermal dose ( mg/ kg/ day) . 33 References 1) Becker, J. ( 2000) Revised Occupational and Residential Exposure Assessment and Recommendations for the Reregistration Eligibility Decision Document for Disulfoton. Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. February 7, 2000. 2) Becker, J. ( 2000) Amendment to the the Disulfoton Occupational and Residential Exposure and Risk Assessment. Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. August 24, 2000. 3) U. S. EPA ( 2001) Disulfoton: Revised ( 3 rd ) Report of Hazard Identification Assessment Review Committee. April 10, 2001. 4) Disulfoton Labels. 5) U. S. EPA ( 1998) Disulfoton LUIS Table for Exposure Assessors ( PRD report dated 11/ 06/ 96 and report run date 02/ 04/ 98) . 6) U. S. EPA ( 1998) PHED Surrogate Exposure Guide, Version 1.1. Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. August 1998. 7) Bangs, G. ( 2001) Summary of HED s Reviews of Outdoor Residential Exposure Task Force ( ORETF) Chemical Handler Exposure Studies; MRID 449722­ 01. Memorandum from Gary Bangs ( HED) to Demson Fuller ( Special Review and Reregistration Division) , April 30, 2001. 8) Dawson, J. ( 2001) Aldicarb. Review of aldicarb ( Temik 10G) granular backpack mixer/ loader/ applicator study ( MRID 451672­ 01) in bananas as a source of surrogate data for ethoprop exposure and assessment. Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. October 17, 2000. 9) Dawson, J. ( 2001) Ethoprop. Review of fipronil granular mixer/ loader/ applicator study ( MRID 452507­ 01) in bananas as a source of surrogate data and accompanying ethoprop risk assessment. Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. January 5, 2001. 10) Versar, Inc. 1999. Review of the DFR Study ­ Dissipation of Dislodgeable Foliar Disulfoton Residues from Di­ Syston ® 8 Treated Potatoes ( MRID No. 446880­ 01) . January 4, 1999. 11) U. S. EPA ( 2001) Recommended Revisions to the Standard Operating Procedures ( SOPs) for Residential Exposure Assessments, Science Advisory Council for Exposure Policy No. 12. Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. February 22, 2001. cc: RRB2 Files APPENDIX HANDLER EXPOSURE AND RISK SUMMARY TABLES FOR REVISED OCCUPATIONAL EXPOSURE ASSESSMENT FOR THE REREGISTRATION ELIGIBILITY DECISION DOCUMENT FOR DISULFOTON Table 1: Occupational Handler Short­ and Intermediate­ Term Exposures and Risks at Baseline Attire Exposure Scenario Crop Type Application Rate a Amount Handled b ( acres unless specified) Baseline Dermal Unit Exposure ( mg/ lb ai) c Baseline Inhalation Unit Exposure ( ug/ lb ai) d Short­ Term Baseline Dermal Dose e Intermediat e­ Term Baseline Dermal Dose f Baseline Short­ Term Dermal MOE g Baseline Intermediate­ Term Dermal MOE h Baseline Inhalatio n Dose i Baseline Inhalation MOE j Baseline Short­ Term Dermal + Inhalation MOE k Baseline Intermediate­ Term Dermal + Inhalation MOE k MIXER/ LOADER Mixing/ Loading Liquid Formulations for Aerial Application ( 1a) tobacco 4 350 2.9 1. 2 58 21 0. 0086 0.0014 0.024 1. 9 0. 0086 0.0014 asparagus ( SLN) 1 350 15 5. 2 0. 034 0. 0057 0. 006 7. 5 0. 034 0. 0057 barley 1 1200 50 18 0. 01 0. 0017 0. 021 2. 2 0. 01 0. 0017 wheat 0. 75 1200 37 13 0. 013 0. 0022 0. 015 2. 9 0. 013 0. 0022 sorghum 0. 5 1200 25 8. 9 0. 02 0. 0034 0. 01 4. 4 0. 02 0. 0033 potatoes ( foliar) 0. 5 350 7. 3 2. 6 0. 069 0. 011 0. 003 15 0. 069 0. 011 cotton ( SLN) 0. 2 1200 9. 9 3. 6 0. 05 0. 0084 0. 0041 11 0. 05 0. 0084 Mixing/ Loading Liquid Formulations for Chemigation Application ( 1b) potatoes ( foliar) ­ OR, WA, ID, UT 3 350 44 16 0. 011 0. 0019 0. 018 2. 5 0. 011 0. 0019 poplars grown for pulpwood ( SLN) 3 350 44 16 0. 011 0. 0019 0. 018 2. 5 0. 011 0. 0019 cabbage, lettuce 2 350 29 10 0. 017 0. 0029 0. 012 3. 8 0. 017 0. 0029 broccoli, brussels sprouts, cauliflower, cotton 1 350 15 5. 2 0. 034 0. 0057 0. 006 7. 5 0. 034 0. 0057 Mixing/ Loading Liquid Formulations for Groundboom Application ( 1c) tobacco 4 80 13 4. 8 0.038 0. 0063 0.0055 8.2 0. 038 0.0063 poplars grown for pulpwood ( SLN) 3 80 9. 9 3. 6 0. 05 0. 0084 0. 0041 11 0. 05 0. 0084 potatoes ( soil) 3 80 9. 9 3. 6 0. 05 0. 0084 0. 0041 11 0. 05 0. 0084 peas, lentils 2.5 80 8. 3 3 0. 06 0. 01 0. 0034 13 0.06 0.01 beans( dry, snap, lima) , lettuce, peppers, radish grown for seed, cabbage 2 80 6. 6 2. 4 0. 075 0. 013 0. 0027 16 0. 075 0. 013 wheat, barley, cotton, sorghum 1 200 8. 3 3 0. 06 0. 01 0. 0034 13 0. 06 0. 01 asparagus ( SLN) , broccoli, brussels sprouts, cauliflower 1 80 3. 3 1. 2 0. 15 0. 025 0. 0014 33 0. 15 0. 025 potatoes ( foliar) 0. 5 80 1. 7 0. 6 0. 3 0. 05 0. 00069 66 0. 3 0. 05 Loading Granular Formulations for Aerial Application ( 2a) tobacco 4 350 0.0084 1.7 0. 17 0. 06 3 0.5 0. 034 1.3 0. 92 0. 36 potatoes ( soil) 3 350 0. 13 0. 045 4 0. 66 0. 026 1. 8 1. 2 0. 48 peas, lentils 2.5 350 0.11 0. 038 4.8 0. 79 0. 021 2.1 1. 5 0.58 peanuts ( SLN) 2 350 0. 084 0. 03 6 0. 99 0. 017 2. 6 1. 8 0. 72 clover grown for seed ( SLN) 1 350 0. 042 0. 015 12 2 0. 0085 5. 3 3. 7 1. 4 1 Table 1: Occupational Handler Short­ and Intermediate­ Term Exposures and Risks at Baseline Attire continued Exposure Scenario Crop Type Application Rate a Amount Handled b ( acres unless specified) Baseline Dermal Unit Exposure ( mg/ lb ai) c Baseline Inhalation Unit Exposure ( ug/ lb ai) d Short­ Term Baseline Dermal Dose e Intermediat e­ Term Baseline Dermal Dose f Baseline Short­ Term Dermal MOE g Baseline Intermediate­ Term Dermal MOE h Baseline Inhalatio n Dose i Baseline Inhalation MOE j Baseline Short­ Term Dermal + Inhalation MOE k Baseline Intermediate­ Term Dermal + Inhalation MOE k barley, sorghum, wheat 1 1200 0. 14 0. 052 3. 5 0. 58 0. 029 1. 5 1. 1 0. 42 Loading Granular Formulations for Ground Application ( 2b) field­ grown ornamental shrubs 109 40 0. 52 0. 19 0. 96 0. 16 0. 11 0. 42 0. 29 0. 12 field­ grown ornamental trees 37 40 0. 18 0. 064 2. 8 0. 47 0. 036 1. 3 0. 87 0. 34 field­ grown flowers & groundcover 29 40 0. 14 0. 05 3. 6 0. 6 0. 028 1. 6 1. 1 0. 44 field­ grown ornamental trees and shrubs ( inject) and flowers & groundcover 11 40 0. 053 0. 019 9. 5 1. 6 0. 011 4. 2 2. 9 1. 1 coffee trees 8. 3 80 0. 08 0. 029 6. 3 1 0. 016 2. 8 1. 9 0. 76 Christmas trees 78 50 0. 47 0. 17 1. 1 0. 18 0. 095 0. 48 0. 33 0. 13 Christmas trees ( SLN) 4. 5 50 0. 027 0. 0097 19 3. 1 0. 0055 8. 2 5. 7 2. 2 tobacco 4 80 0. 038 0.014 13 2.2 0. 0078 5.8 4 1.6 potatoes ( soil) 3 80 0. 029 0. 01 17 2. 9 0. 0058 7. 7 5. 3 2. 1 peas, lentils 2.5 80 0. 024 0. 0086 21 3.5 0. 0049 9.3 6. 4 2.5 peppers, peanuts ( SLN) , radish grown for seed ( SLN) 2 80 0. 019 0. 0069 26 4. 3 0. 0039 12 8 3. 2 cabbage 1. 5 80 0. 014 0. 0052 35 5. 8 0. 0029 15 11 4. 2 barley, cotton, sorghum, soybeans, wheat 1 200 0. 024 0. 0086 21 3. 5 0. 0049 9. 3 6. 4 2. 5 peanuts, beans ( dry, snap, lima) , brussels sprout, cauliflower, broccoli, clover grown for seed ( SLN) 1 80 0. 0096 0. 0035 52 8. 7 0. 0019 23 16 6. 3 APPLICATOR Applying Sprays with an Airplane ( 3) tobacco 4 350 No Data See Engineering Controls asparagus ( SLN) 1 350 barley 1 1200 wheat 0. 75 1200 sorghum 0. 5 1200 potatoes ( foliar) 0. 5 350 2 Table 1: Occupational Handler Short­ and Intermediate­ Term Exposures and Risks at Baseline Attire continued Exposure Scenario Crop Type Application Rate a Amount Handled b ( acres unless specified) Baseline Dermal Unit Exposure ( mg/ lb ai) c Baseline Inhalation Unit Exposure ( ug/ lb ai) d Short­ Term Baseline Dermal Dose e Intermediat e­ Term Baseline Dermal Dose f Baseline Short­ Term Dermal MOE g Baseline Intermediate­ Term Dermal MOE h Baseline Inhalatio n Dose i Baseline Inhalation MOE j Baseline Short­ Term Dermal + Inhalation MOE k Baseline Intermediate­ Term Dermal + Inhalation MOE k cotton ( SLN) 0. 2 1200 Applying Granulars with an Airplane ( 4) tobacco 4 350 No Data See Engineering Controls potatoes ( soil) 3 350 peas, lentils 2.5 350 peanuts ( SLN) 2 350 barley, sorghum, wheat 1 1200 clover grown for seed ( SLN) 1 350 Applying with a Groundboom ( 5) tobacco 4 80 0. 014 0.74 0.064 0.023 7.8 1. 3 0.0034 13 4.9 1. 2 poplars grown for pulpwood ( SLN) 3 80 0. 048 0. 017 10 1. 7 0. 0025 18 6. 6 1. 6 potatoes ( soil) 3 80 0. 048 0. 017 10 1. 7 0. 0025 18 6. 6 1. 6 peas, lentils 2.5 80 0. 04 0. 014 13 2.1 0. 0021 21 7.9 1. 9 beans( dry, snap, lima) , lettuce, peppers, radish grown for seed, cabbage 2 80 0. 032 0. 012 16 2. 6 0. 0017 27 9. 8 2. 4 wheat, barley, cotton, sorghum 1 200 0. 04 0. 014 13 2. 1 0. 0021 21 7. 9 1. 9 asparagus ( SLN) , broccoli, brussels sprouts, cauliflower 1 80 0. 016 0. 0058 31 5. 2 0. 00085 53 20 4. 7 potatoes ( foliar) 0. 5 80 0. 008 0. 0029 63 10 0. 00042 110 39 9. 5 Applying Granulars with a Tractor Drawn Spreader ( 6) field­ grown ornamental shrubs 109 40 0. 0099 1. 2 0. 62 0. 22 0. 81 0. 14 0. 075 0. 6 0. 35 0. 11 field­ grown ornamental trees 37 40 0. 21 0. 075 2. 4 0. 4 0. 025 1. 8 1 0. 33 field­ grown flowers & groundcover 29 40 0. 16 0. 059 3 0. 51 0. 02 2. 3 1. 3 0. 41 field­ grown ornamental trees & shrubs ( inject) and flowers & groundcover 11 40 0. 062 0. 022 8 1. 3 0. 0075 6 3. 4 1. 1 coffee trees 8. 3 80 0. 094 0. 034 5. 3 0. 89 0. 011 4 2. 3 0. 72 Christmas trees 78 50 0. 55 0. 2 0. 91 0. 15 0. 067 0. 67 0. 39 0. 12 Christmas trees ( SLN) 4. 5 50 0. 032 0. 011 16 2. 6 0. 0039 12 6. 7 2. 1 tobacco 4 80 0. 045 0.016 11 1.8 0. 0055 8.2 4. 7 1.5 3 Table 1: Occupational Handler Short­ and Intermediate­ Term Exposures and Risks at Baseline Attire continued Exposure Scenario Crop Type Application Rate a Amount Handled b ( acres unless specified) Baseline Dermal Unit Exposure ( mg/ lb ai) c Baseline Inhalation Unit Exposure ( ug/ lb ai) d Short­ Term Baseline Dermal Dose e Intermediat e­ Term Baseline Dermal Dose f Baseline Short­ Term Dermal MOE g Baseline Intermediate­ Term Dermal MOE h Baseline Inhalatio n Dose i Baseline Inhalation MOE j Baseline Short­ Term Dermal + Inhalation MOE k Baseline Intermediate­ Term Dermal + Inhalation MOE k potatoes ( soil) 3 80 0. 034 0. 012 15 2. 5 0. 0041 11 6. 3 2 peas, lentils 2.5 80 0. 028 0.01 18 2.9 0. 0034 13 7.5 2. 4 peppers, peanuts ( SLN) , radish grown for seed ( SLN) 2 80 0. 023 0. 0081 22 3. 7 0. 0027 16 9. 4 3 cabbage 1. 5 80 0. 017 0. 0061 29 4. 9 0. 0021 22 13 4 barley, cotton, sorghum, soybeans, wheat 1 200 0. 028 0. 01 18 2. 9 0. 0034 13 7. 5 2. 4 peanuts, beans ( dry, snap, lima) , brussels sprout, cauliflower, broccoli, clover grown for seed­ SLN 1 80 0. 011 0. 0041 44 7. 4 0. 0014 33 19 6 MIXER/ LOADER/ APPLICATOR Loading/ Applying with a Push Type Spreader l ( ORETF) ( 7) field­ grown ornamental shrubs 109 5 0. 35 7. 5 2. 7 0. 98 0. 18 0. 031 0. 058 0. 77 0. 15 0. 029 field­ grown ornamental trees 37 5 0. 93 0. 33 0. 54 0. 09 0. 02 2. 3 0. 44 0. 087 field­ grown flowers & groundcover 29 5 0. 73 0. 26 0. 69 0. 11 0. 016 2. 9 0. 56 0. 11 field­ grown ornamental trees & shrubs ( inject) and flowers & groundcover 11 5 0. 28 0. 099 1. 8 0. 3 0. 0059 7. 6 1. 5 0. 29 Christmas trees 78 5 2 0. 7 0. 26 0. 043 0. 042 1. 1 0. 21 0. 041 Christmas trees ( SLN) 4. 5 5 0. 11 0. 041 4. 4 0. 74 0. 0024 19 3. 6 0. 71 Loading/ Applying with a Bellygrinder ( PHED) ( 8) field­ grown ornamental shrubs 109 1 10 62 16 5. 6 0. 032 0. 0054 0. 097 0. 47 0. 03 0. 0053 field­ grown ornamental trees 37 1 5. 3 1. 9 0. 095 0. 016 0. 033 1. 4 0. 088 0. 016 field­ grown flowers & groundcover 29 1 4. 1 1. 5 0. 12 0. 02 0. 026 1. 8 0. 11 0. 02 field­ grown ornamental trees & shrubs ( inject) and flowers & groundcover 11 1 1. 6 0. 57 0. 32 0. 053 0. 0097 4. 6 0. 3 0. 052 4 Table 1: Occupational Handler Short­ and Intermediate­ Term Exposures and Risks at Baseline Attire continued Exposure Scenario Crop Type Application Rate a Amount Handled b ( acres unless specified) Baseline Dermal Unit Exposure ( mg/ lb ai) c Baseline Inhalation Unit Exposure ( ug/ lb ai) d Short­ Term Baseline Dermal Dose e Intermediat e­ Term Baseline Dermal Dose f Baseline Short­ Term Dermal MOE g Baseline Intermediate­ Term Dermal MOE h Baseline Inhalatio n Dose i Baseline Inhalation MOE j Baseline Short­ Term Dermal + Inhalation MOE k Baseline Intermediate­ Term Dermal + Inhalation MOE k Christmas trees 78 1 11 4 0. 045 0. 0075 0. 069 0. 65 0. 042 0. 0074 Christmas trees ( SLN) 4. 5 1 0. 64 0. 23 0. 78 0. 13 0. 004 11 0. 73 0. 13 Loading/ Applying Granulars with a Pump Feed Backpack Spreader m ( Aldicarb) ( 9a) field­ grown ornamental shrubs 109 10 No Data See PPE 4. 2 No Data See PPE 0. 065 0. 69 No Data See PPE 5 0. 033 1. 4 field­ grown ornamental trees 37 10 0. 022 2 5 0. 011 4. 1 field­ grown flowers & groundcover 29 10 0. 017 2. 6 5 0. 0087 5. 2 field­ grown ornamental trees & shrubs ( inject) and flowers & groundcover 11 10 0. 0066 6. 8 5 0. 0033 14 coffee trees 8.3 10 0. 005 9 5 0. 0025 18 Christmas trees 78 10 0. 047 0. 96 5 0. 023 1. 9 Christmas trees ( SLN) 4. 5 10 0. 0027 17 5 0. 0014 33 potted ornamentals 0. 2 lb ai/ day ­ 0. 000012 3800 Loading/ Applying Granular with a Gravity­ Feed Backpack Spreader n ( Fipronil) ( 9b) field­ grown ornamental shrubs 109 10 No Data See PPE 44 No Data See PPE 0. 69 0. 066 No Data See PPE 5 0. 34 0. 13 field­ grown ornamental trees 37 10 0. 23 0. 19 5 0. 12 0. 39 field­ grown flowers & groundcover 29 10 0. 18 0. 25 5 0. 091 0. 49 field­ grown ornamental trees & shrubs ( inject) and flowers & groundcover s 11 10 0. 069 0. 65 5 0. 035 1. 3 coffee trees 8.3 10 0. 052 0. 86 5 0. 026 1. 7 Christmas trees 78 10 0. 49 0. 092 5 0. 25 0. 18 Christmas trees ( SLN) 4. 5 10 0. 028 1. 6 5 0. 014 3. 2 potted ornamentals 0. 2 lb ai/ day ­ 0. 00013 360 5 Table 1: Occupational Handler Short­ and Intermediate­ Term Exposures and Risks at Baseline Attire continued Exposure Scenario Crop Type Application Rate a Amount Handled b ( acres unless specified) Baseline Dermal Unit Exposure ( mg/ lb ai) c Baseline Inhalation Unit Exposure ( ug/ lb ai) d Short­ Term Baseline Dermal Dose e Intermediat e­ Term Baseline Dermal Dose f Baseline Short­ Term Dermal MOE g Baseline Intermediate­ Term Dermal MOE h Baseline Inhalatio n Dose i Baseline Inhalation MOE j Baseline Short­ Term Dermal + Inhalation MOE k Baseline Intermediate­ Term Dermal + Inhalation MOE k Scoop and Bucket o ( Fipronil) ( 10) field­ grown ornamental shrubs 109 10 No Data See PPE 45 No Data See PPE 0. 7 0. 064 No Data See PPE 5 0. 35 0. 13 field­ grown ornamental trees 37 10 0. 24 0. 19 5 0. 12 0. 38 field­ grown flowers & groundcover 29 10 0. 19 0. 24 5 0. 093 0. 48 field­ grown ornamental trees & shrubs ( inject) and flowers & groundcover s 11 10 0. 071 0. 64 5 0. 035 1. 3 coffee trees 8.3 10 0. 053 0. 84 5 0. 027 1. 7 Christmas trees 78 10 0. 5 0. 09 5 0. 25 0. 18 Christmas trees ( SLN) 4. 5 10 0. 029 1. 6 5 0. 014 3. 1 potted ornamentals 0. 2 lb ai/ day ­ 0. 00013 350 FLAGGER Flagging Aerial Spray Applications ( 11) tobacco 4 350 0.011 0.35 0.22 0. 079 2.3 0. 38 0. 007 6.4 1. 7 0.36 asparagus ( SLN) , barley 1 350 0. 055 0. 02 9. 1 1. 5 0. 0018 26 6. 7 1. 4 barley 1 1200 0. 19 0. 068 2. 7 0. 44 0. 006 7. 5 2 0. 42 wheat 0. 75 1200 0. 14 0. 051 3. 5 0. 59 0. 0045 10 2. 6 0. 56 sorghum 0. 5 1200 0. 094 0. 034 5. 3 0. 88 0. 003 15 3. 9 0. 83 potatoes ( foliar) . sorghum 0. 5 350 0. 028 0. 0099 18 3 0. 00088 51 13 2. 9 cotton ( SLN) 0. 2 350 0. 011 0. 004 45 7. 6 0. 00035 130 34 7. 2 Flagging Granular Applications ( 12) tobacco 4 350 0.0028 0.15 0.056 0.02 8.9 1. 5 0.003 15 5.6 1. 4 potatoes ( soil) 3 350 0. 042 0. 015 12 2 0. 0023 20 7. 5 1. 8 peas, lentils 2.5 350 0.035 0.013 14 2.4 0. 0019 24 9 2. 2 peanuts ( SLN) 2 350 0. 028 0. 01 18 3 0. 0015 30 11 2. 7 clover grown for seed ( SLN) , barley, sorghum, wheat 1 350 0. 014 0. 005 36 6 0. 00075 60 22 5. 4 barley, sorghum, wheat 1 1200 0. 048 0. 017 10 1. 7 0. 0026 18 6. 5 1. 6 6 Table 1: Occupational Handler Short­ and Intermediate­ Term Exposures and Risks at Baseline Attire continued Footnotes: a Application rates are based on maximum values found on various labels or proposed by registrant. In most scenarios, a range of maximum application rates is used to represent the range of rates for different crops/ sites/ uses. Most application rates upon which the analysis is based are presented as lb ai/ A. In the case of ornamentals in pots, the application rate is presented as lb ai/ day) . Specific application rates and the corresponding EPA Reg. numbers that are intended as examples of each exposure assessment scenario are presented below: 4.0 lb/ A EC formulations: tobacco ( Reg # 3125­ 307) 3. 0 lb/ A EC formulations: potatoes: foliar OR, WA, ID UT ( Reg # 3125­ 307) ; potatoes: soil ( Reg # 3125­ 307) ; poplars grown for pulpwood ( Reg # 3125­ 307­ ­ OR­ 910027) 2.5 lb/ A EC formulations: peas and lentils ( Reg # 3125­ 307) 2. 0 lb/ A EC formulations: beans: dry, snap, lima ( Reg # 3125­ 307) ; cabbage ( Reg # 3125­ 307) ; lettuce ( Reg # 3125­ 307) ; peppers ( Reg # 3125­ 307) ; radish grown for seed ( Reg # 3125­ 307­ WA­ 920026) ; 1. 0 lb/ A EC formulations: asparagus ( SLN) ( Reg # 3125­ 307­ CA­ 840192) ; barley ( Reg # 3125­ 307) ; broccoli ( Reg # 3125­ 307) ; Brussels sprouts ( Reg # 3125­ 307) ; cauliflower ( Reg # 3125­ 307) ; cotton ( Reg # 3125­ 307) ; sorghum ( Reg # 3125­ 307) ; wheat ( Reg # 3125­ 307) ; 0. 75 lb/ A EC formulations: wheat ( Reg # 3125­ 307) 0. 5 lb/ A EC formulations: sorghum ( Reg # 3125­ 307) ; potatoes: foliar ( Reg # 3125­ 307) 0. 2 lb/ A EC formulations: cotton ( ( Reg # 3125­ 307 TX 860007) 109 lb/ A Granular formulations: field­ grown ornamental shrubs ( Reg # 3125­ 172) based on the assumption that the shrubs are two feet tall and occupy two square feet ( i. e. , roses) ; 78 lb/ A Granular formulations: Christmas trees ( Reg # 3125­ 172) based on the assumption that the trunk is 2 inches in diameter and are planted 1700 trees per acre; 37 lb/ A Granular formulations: field­ grown ornamental trees ( Reg # 3125­ 172) based on the assumption that the trunk is 2 inches in diameters and are planted 800 trees per acre; 29 lb/ A Granular formulations: field­ grown flowers and groundcover ( Reg # 3125­ 172) 11 lb/ A Granular formulations: field­ grown ornamental trees and shrubs: injection ( Reg # 3125­ 172) 8. 3 lb/ A Granular formulations: coffee trees ( Reg # 3125­ 172) based on the assumption that the trees are 8 feet tall and are planted 435 trees per acre 4. 5 lb/ A Granular formulations: Christmas trees ( ( Reg # 3125­ 172­ NC­ 880001) 4.0 lb/ A Granular formulations: tobacco ( Reg # 3125­ 172) ; 3. 0 lb/ A Granular formulations: potatoes: soil ( Reg # 3125­ 172) ; 2.5 lb/ A Granular formulations: peas and lentils ( Reg # 3125­ 172) ; 2. 0 lb/ A Granular formulations: peanuts ( Reg # 3125­ 172­ NC­ 920011) ; peppers ( Reg # 3125­ 172) ; radish grown for seed ( ( Reg # 3125­ 172­ WA­ 920027) ; 1. 5 lb/ A Granular formulations: cabbage ( Reg # 3125­ 172) ; 1. 0 lb/ A Granular formulations: barley ( Reg # 3125­ 172) ; beans: dry, snap, lima: ( Reg # 3125­ 172) ; broccoli ( Reg # 3125­ 172) ; Brussels sprouts ( Reg # 3125­ 172) ; cauliflower ( Reg # 3125­ 172) ; clover grown for seed ( Reg # 3125­ 172­ WA­ 980004) ; cotton ( Reg # 3125­ 172) ; peanuts ( Reg # 3125­ 172) ; sorghum ( Reg # 3125­ 172) ; soybeans ( Reg # 3125­ 172) ; wheat ( Reg # 3125­ 172) ; 0. 2 lb/ day Granular formulations: potted ornamentals ( Reg # 3125­ 172) ; based on the assumption that 350 pots that are 12 inches in diameter are treated each day; b Amount handled per day values are based on HED Exposure SAC Policy # 009 Standard Values for Daily Acres Treated in Agriculture, revised June 23, 2000, or best professional judgment when data is not available. c Unless otherwise footnoted, baseline dermal unit exposure values are from PHED Surrogate Exposure Guide, draft version August, 1998. Baseline dermal exposure assumes long pants, long sleeved shirt, no gloves, open mixing/ loading, open cab/ tractor. ( See Exposure Scenarios Descriptions Table for further information. ) d Unless otherwise footnoted, inhalation unit exposure values are from PHED Surrogate Exposure Guide, draft version August, 1998. Baseline inhalation exposure assessed as a no respirator scenario . e Short­ term baseline dermal dose ( mg/ kg/ d) = [ unit dermal exposure ( mg/ lb ai) * application rate ( lb ai/ acre) * daily acres treated * dermal absorption ( 100% ) ] / body weight ( 70 kg) . f Intermediate­ term baseline dermal dose ( mg/ kg/ d) = [ unit dermal exposure ( mg/ lb ai) * application rate ( lb ai/ acre) * daily acres treated * dermal absorption ( 36% ) ] / body weight ( 70 kg) . g Short­ term dermal MOE = NOAEL ( 0. 5 mg/ kg/ d) / short­ term daily dermal dose. Uncertainty Factor = 100. h Intermediate­ term dermal MOE = NOAEL ( 0. 03 mg/ kg/ day) / intermediate­ term daily dermal dose. . Uncertainty Factor = 100. i Baseline Inhalation Dose ( mg/ kg/ d) = ( unit exposure ( F g/ lb ai) * ( 1mg/ 1000 F g) conversion * appl. rate ( lb ai/ A) * acres treated/ day) / body weight ( 70 kg) [Note: application rate and acres treated/ day are replaced by pounds handled per day for ornamentals in pots scenario. j Baseline inhalation MOE = NOAEL ( 0. 045 mg/ kg/ day) / short­ term inhalation dose. Uncertainty Factor = 100. k Total Baseline Short­ or Intermediate­ term MOE = 1 1 1 % dermal MOE inhalation MOE l Unit exposure values from Outdoor Residential Exposure Task Force study: ORETF Study Number OMA001. Exposure of Professional Lawn Care Workers During the Mixing, Loading and Application of Granular Turf Pesticides Utilizing a Surrogate Compound . Values from EPA memo dated April 30, 2001 using same standard clothing assumptions as for PHED ( footnotes c and d) . Geometric mean is used for dermal values and median is used for inhalation value. m Unit exposure values from a loader/ applicator study using passive dosimetry and pump­ feed backpack equipment to load and apply aldicarb granules to the soil at the base of banana trees. MRID # 451672­ 01 Worker Exposure Study During Application in Banana Plantation with Temik 10G . Applicators wore baseline attire plus Tyvek gloves and a back apron. Geometric mean is used for dermal and inhalation values. 7 Table 1: Occupational Handler Short­ and Intermediate­ Term Exposures and Risks at Baseline Attire continued n Unit exposure values from a loader/ applicator study using passive dosimetry and gravity­ feed backpack equipment to load and apply fipronil granules to the soil at the base of banana trees. MRID # 452507­ 02 Worker Exposure Study During Application of Regent 10GR in Banana Plantation. Applicators wore baseline attire plus PVC gloves. Geometric mean is used for dermal and inhalation values. o Unit exposure values from a loader/ applicator study using passive dosimetry and handheld bucket and scoop equipment to load and apply fipronil granules to the soil at the base of banana trees. MRID # 452507­ 02 Worker Exposure Study During Application of Regent 10GR in Banana Plantation. Applicators wore baseline attire plus PVC gloves. Geometric mean is used for dermal and inhalation values. 8 Table 2: Occupational Handler Short­ Term Exposures and Risks with Personal Protective Equipment Exposure Scenario Crop Type Application Rate a Acres Treated b Dermal ( gloves) Unit Exposure c ( mg/ lb ai) Dermal ( gloves, double layers) Unit Exposure c ( mg/ lb ai) Dermal ( gloves) MOE d Dermal ( gloves, double layers) MOE d Inhalation ( respirator) Unit Exposure e ( ug/ lb ai) Inhalation ( no respirator) MOE f Inhalation ( respirator) MOE g Dermal ( gloves) + Inhalation ( no respirator) MOE h Dermal ( gloves) + Inhalation ( respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( no respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( respirator) MOE h MIXER/ LOADER Mixing/ Loading Liquid Formulations for Aerial Application ( 1a) tobacco 4 350 0.023 0.017 1.1 1. 5 0. 24 1.9 9. 4 0.69 0.97 0.82 1.3 asparagus ( SLN) 1 350 4. 3 5. 9 7. 5 38 2. 8 3. 9 3. 3 5. 1 barley 1 1200 1. 3 1. 7 2. 2 11 0. 8 1. 1 0. 96 1. 5 wheat 0. 75 1200 1. 7 2. 3 2. 9 15 1. 1 1. 5 1. 3 2 sorghum 0. 5 1200 2. 5 3. 4 4. 4 22 1. 6 2. 3 1. 9 3 potatoes ( foliar) 0. 5 350 8. 7 12 15 75 5. 5 7. 8 6. 6 10 cotton ( SLN) 0. 2 1200 6. 3 8. 6 11 55 4 5. 7 4. 8 7. 4 Mixing/ Loading Liquid Formulations for Chemigation Application ( 1b) potatoes ( foliar) ­ OR, WA, ID, UT 3 350 1. 4 2 2. 5 13 0. 92 1. 3 1. 1 1. 7 poplars grown for pulpwood ( SLN) 3 350 1. 4 2 2. 5 13 0. 92 1. 3 1. 1 1. 7 cabbage, lettuce 2 350 2. 2 2. 9 3. 8 19 1. 4 1. 9 1. 6 2. 5 broccoli, brussels sprouts, cauliflower, cotton 1 350 4. 3 5. 9 7. 5 38 2. 8 3. 9 3. 3 5. 1 Mixing/ Loading Liquid Formulations for Groundboom Application ( 1c) tobacco 4 80 4. 8 6.4 8. 2 41 3 4. 3 3.6 5. 6 poplars grown for pulpwood ( SLN) 3 80 6. 3 8. 6 11 55 4 5. 7 4. 8 7. 4 potatoes ( soil) 3 80 6. 3 8. 6 11 55 4 5. 7 4. 8 7. 4 peas, lentils 2.5 80 7. 6 10 13 66 4.8 6. 8 5.8 8. 9 beans( dry, snap, lima) , lettuce, peppers, radish grown for seed, cabbage 2 80 9. 5 13 16 82 6 8. 5 7. 2 11 wheat, barley, cotton, sorghum 1 200 7. 6 10 13 66 4. 8 6. 8 5. 8 8. 9 asparagus ( SLN) , broccoli, brussels sprouts, cauliflower 1 80 19 26 33 160 12 17 14 22 potatoes ( foliar) 0. 5 80 38 51 66 330 24 34 29 44 Loading Granular Formulations for Aerial Application ( 2a) tobacco 4 350 0.0069 0.0034 3.6 7. 4 0.34 1.3 6. 6 0.97 2.3 1. 1 3.5 potatoes ( soil) 3 350 4. 8 9. 8 1. 8 8. 8 1. 3 3. 1 1. 5 4. 6 peas, lentils 2.5 350 5.8 12 2. 1 11 1.6 3. 7 1.8 5. 6 peanuts ( SLN) 2 350 7. 2 15 2. 6 13 1. 9 4. 7 2. 2 7 9 Table 2 Occupational Handler Short­ Term Exposures and Risks with Personal Protective Equipment continued Exposure Scenario Crop Type Application Rate a Acres Treated b Dermal ( gloves) Unit Exposure c ( mg/ lb ai) Dermal ( gloves, double layers) Unit Exposure c ( mg/ lb ai) Dermal ( gloves) MOE d Dermal ( gloves, double layers) MOE d Inhalation ( respirator) Unit Exposure e ( ug/ lb ai) Inhalation ( no respirator) MOE f Inhalation ( respirator) MOE g Dermal ( gloves) + Inhalation ( no respirator) MOE h Dermal ( gloves) + Inhalation ( respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( no respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( respirator) MOE h clover grown for seed ( SLN) 1 350 14 29 5. 3 26 3. 9 9. 4 4. 5 14 barley, sorghum, wheat 1 1200 4. 2 8. 6 1. 5 7. 7 1. 1 2. 7 1. 3 4. 1 Loading Granular Formulations for Ground Application ( 2b) field­ grown ornamental shrubs 109 40 1. 2 2. 4 0. 42 2. 1 0. 31 0. 75 0. 36 1. 1 field­ grown ornamental trees 37 40 3. 4 7 1. 3 6. 3 0. 92 2. 2 1. 1 3. 3 field­ grown flowers & groundcover 29 40 4. 4 8. 9 1. 6 8 1. 2 2. 8 1. 4 4. 2 field­ grown ornamental trees and shrubs ( inject) and flowers & groundcover 11 40 12 23 4. 2 21 3. 1 7. 4 3. 6 11 coffee trees 8. 3 80 7. 6 16 2. 8 14 2 4. 9 2. 4 7. 3 Christmas trees 78 50 1. 3 2. 6 0. 48 2. 4 0. 35 0. 84 0. 4 1. 3 Christmas trees ( SLN) 4. 5 50 23 46 8. 2 41 6 15 7 22 tobacco 4 80 16 32 5. 8 29 4.2 10 4. 9 15 potatoes ( soil) 3 80 21 43 7. 7 39 5. 7 14 6. 5 20 peas, lentils 2.5 80 25 51 9. 3 46 6.8 16 7. 9 24 peppers, peanuts ( SLN) , radish grown for seed ( SLN) 2 80 32 64 12 58 8. 5 20 9. 8 30 cabbage 1. 5 80 42 86 15 77 11 27 13 41 barley, cotton, sorghum, soybeans, wheat 1 200 25 51 9. 3 46 6. 8 16 7. 9 24 peanuts, beans ( dry, snap, lima) , brussels sprout, cauliflower, broccoli, clover grown for seed ( SLN) 1 80 63 130 23 120 17 41 20 61 APPLICATOR 10 Table 2 Occupational Handler Short­ Term Exposures and Risks with Personal Protective Equipment continued Exposure Scenario Crop Type Application Rate a Acres Treated b Dermal ( gloves) Unit Exposure c ( mg/ lb ai) Dermal ( gloves, double layers) Unit Exposure c ( mg/ lb ai) Dermal ( gloves) MOE d Dermal ( gloves, double layers) MOE d Inhalation ( respirator) Unit Exposure e ( ug/ lb ai) Inhalation ( no respirator) MOE f Inhalation ( respirator) MOE g Dermal ( gloves) + Inhalation ( no respirator) MOE h Dermal ( gloves) + Inhalation ( respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( no respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( respirator) MOE h Applying Sprays with an Airplane ( 3) tobacco 4 350 No Data See Engineering Controls asparagus ( SLN) 1 350 barley 1 1200 wheat 0. 75 1200 sorghum 0. 5 1200 potatoes ( foliar) 0. 5 350 cotton ( SLN) 0. 2 1200 Applying Granulars with an Airplane ( 4) tobacco 4 350 No Data See Engineering Controls potatoes ( soil) 3 350 peas, lentils 2.5 350 peanuts ( SLN) 2 350 barley, sorghum, wheat 1 1200 clover grown for seed ( SLN) 1 350 Applying with a Groundboom ( 5) tobacco 4 80 0. 014 0.011 7.8 9. 9 0.15 13 66 4.9 7 5.7 8. 6 poplars grown for pulpwood ( SLN) 3 80 10 13 18 88 6. 6 9. 3 7. 6 12 potatoes ( soil) 3 80 10 13 18 88 6. 6 9. 3 7. 6 12 peas, lentils 2.5 80 13 16 21 110 7.9 11 9. 1 14 beans( dry, snap, lima) , lettuce, peppers, radish grown for seed, cabbage 2 80 16 20 27 130 9. 8 14 11 17 wheat, barley, cotton, sorghum 1 200 13 16 21 110 7. 9 11 9. 1 14 asparagus ( SLN) , broccoli, brussels sprouts, cauliflower 1 80 31 40 53 260 20 28 23 35 potatoes ( foliar) 0. 5 80 63 80 110 530 39 56 46 69 Applying Granulars with a Tractor Drawn Spreader ( 6) field­ grown ornamental shrubs 109 40 0. 0072 0. 042 1. 1 1. 9 0. 24 0. 6 3 0. 39 0. 81 0. 46 1. 2 11 Table 2 Occupational Handler Short­ Term Exposures and Risks with Personal Protective Equipment continued Exposure Scenario Crop Type Application Rate a Acres Treated b Dermal ( gloves) Unit Exposure c ( mg/ lb ai) Dermal ( gloves, double layers) Unit Exposure c ( mg/ lb ai) Dermal ( gloves) MOE d Dermal ( gloves, double layers) MOE d Inhalation ( respirator) Unit Exposure e ( ug/ lb ai) Inhalation ( no respirator) MOE f Inhalation ( respirator) MOE g Dermal ( gloves) + Inhalation ( no respirator) MOE h Dermal ( gloves) + Inhalation ( respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( no respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( respirator) MOE h field­ grown ornamental trees 37 40 3. 3 5. 6 1. 8 8. 9 1. 2 2. 4 1. 3 3. 4 field­ grown flowers & groundcover 29 40 4. 2 7. 2 2. 3 11 1. 5 3. 1 1. 7 4. 4 field­ grown ornamental trees & shrubs ( inject) and flowers & groundcover 11 40 11 19 6 30 3. 9 8. 1 4. 5 12 coffee trees 8.3 80 7. 3 13 4 20 2. 6 5.3 3 7.7 Christmas trees 78 50 1. 2 2. 1 0. 67 3. 4 0. 44 0. 91 0. 51 1. 3 Christmas trees ( SLN) 4. 5 50 22 37 12 58 7. 6 16 8. 9 23 tobacco 4 80 15 26 8. 2 41 5.3 11 6. 2 16 potatoes ( soil) 3 80 20 35 11 55 7. 1 15 8. 3 21 peas, lentils 2.5 80 24 42 13 66 8. 5 18 10 25 peppers, peanuts ( SLN) , radish grown for seed ( SLN) 2 80 30 52 16 82 11 22 12 32 cabbage 1. 5 80 41 69 22 110 14 30 17 42 barley, cotton, sorghum, soybeans, wheat 1 200 24 42 13 66 8. 5 18 10 25 peanuts, beans ( dry, snap, lima) , brussels sprout, cauliflower, broccoli, clover grown for seed­ SLN 1 80 61 100 33 160 21 44 25 64 MIXER/ LOADER/ APPLICATOR Loading/ Applying with a Push Type Spreader i ( ORETF) ( 7) field­ grown ornamental shrubs 109 5 0. 22 0. 11 0. 29 0. 58 1. 5 0. 77 3. 9 0. 21 0. 27 0. 33 0. 51 field­ grown ornamental trees 37 5 0. 86 1. 7 2. 3 11 0. 62 0. 8 0. 98 1. 5 12 Table 2 Occupational Handler Short­ Term Exposures and Risks with Personal Protective Equipment continued Exposure Scenario Crop Type Application Rate a Acres Treated b Dermal ( gloves) Unit Exposure c ( mg/ lb ai) Dermal ( gloves, double layers) Unit Exposure c ( mg/ lb ai) Dermal ( gloves) MOE d Dermal ( gloves, double layers) MOE d Inhalation ( respirator) Unit Exposure e ( ug/ lb ai) Inhalation ( no respirator) MOE f Inhalation ( respirator) MOE g Dermal ( gloves) + Inhalation ( no respirator) MOE h Dermal ( gloves) + Inhalation ( respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( no respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( respirator) MOE h field­ grown flowers & groundcover 29 5 1. 1 2. 2 2. 9 14 0. 8 1 1. 2 1. 9 field­ grown ornamental trees & shrubs ( inject) and flowers & groundcover 11 5 2. 9 5. 8 7. 6 38 2. 1 2. 7 3. 3 5 Christmas trees 78 5 0. 41 0. 82 1. 1 5. 4 0. 3 0. 38 0. 46 0. 71 Christmas trees ( SLN) 4. 5 5 7. 1 14 19 93 5. 1 6. 6 8 12 Loading/ Applying with a Bellygrinder ( PHED) ( 8) field­ grown ornamental shrubs 109 1 9. 3 5. 7 0. 035 0. 056 12 0. 47 2. 4 0. 032 0. 034 0. 05 0. 055 field­ grown ornamental trees 37 1 0. 1 0. 17 1. 4 7. 1 0. 095 0. 1 0. 15 0. 16 field­ grown flowers & groundcover 29 1 0. 13 0. 21 1. 8 9. 1 0. 12 0. 13 0. 19 0. 21 field­ grown ornamental trees & shrubs ( inject) and flowers & groundcover 11 1 0. 34 0. 56 4. 6 24 0. 32 0. 34 0. 5 0. 55 Christmas trees 78 1 0. 048 0. 079 0. 65 3. 4 0. 045 0. 048 0. 07 0. 077 Christmas trees ( SLN) 4. 5 1 0. 84 1. 4 11 58 0. 78 0. 82 1. 2 1. 3 Loading/ Applying Granulars with a Pump­ Feed Backpack Spreader j ( Aldicarb ) ( 9a) field­ grown ornamental shrubs 109 10 0. 01 with apron on back No Data 3. 2 ( apron) No Data 0. 84 0. 69 3. 4 0. 57 ( apron) 1. 7 ( apron) No Data No Data 5 6. 4 ( apron) 1. 4 6. 9 1. 1 ( apron) 3. 3 ( apron) field­ grown ornamental trees 37 10 9. 5 ( apron) 2 10 1. 7 ( apron) 4. 9 ( apron) 5 19 ( apron) 4. 1 20 3. 3 ( apron) 9. 8 ( apron) field­ grown flowers & groundcover 29 10 12 ( apron) 2. 6 13 2. 1 ( apron) 6. 2 ( apron) 5 24 ( apron) 5. 2 26 4. 3 ( apron) 12 ( apron) field­ grown ornamental trees & shrubs ( inject) and flowers & groundcover 11 10 32 ( apron) 6. 8 34 5. 6 ( apron) 16 ( apron) 5 64 ( apron) 14 68 11 ( apron) 33 ( apron) coffee trees 8. 3 10 42 ( apron) 9 45 7. 4 ( apron) 22 ( apron) 5 84 ( apron) 18 90 15 ( apron) 44 ( apron) 13 Table 2 Occupational Handler Short­ Term Exposures and Risks with Personal Protective Equipment continued Exposure Scenario Crop Type Application Rate a Acres Treated b Dermal ( gloves) Unit Exposure c ( mg/ lb ai) Dermal ( gloves, double layers) Unit Exposure c ( mg/ lb ai) Dermal ( gloves) MOE d Dermal ( gloves, double layers) MOE d Inhalation ( respirator) Unit Exposure e ( ug/ lb ai) Inhalation ( no respirator) MOE f Inhalation ( respirator) MOE g Dermal ( gloves) + Inhalation ( no respirator) MOE h Dermal ( gloves) + Inhalation ( respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( no respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( respirator) MOE h Christmas trees 78 10 4. 5 ( apron) 0. 96 4. 8 0. 79 ( apron) 2. 3 ( apron) 5 9 ( apron) 1. 9 9. 6 1. 6 ( apron) 4. 6 ( apron) Christmas trees ( SLN) 4. 5 10 78 ( apron) 17 83 14 ( apron) 40 ( apron) 5 160 ( apron) 33 170 27 ( apron) 80 ( apron) Potted ornamentals 0. 2 lb ai/ day ­ 18000 ( apron) 3800 19000 3100 ( apron) 9100 ( apron) Loading/ Applying Granular with a Gravity­ Feed Backpack Spreader k ( Fipronil) ( 9b) field­ grown ornamental shrubs 109 10 0. 6 No Data 0. 054 No Data 8. 8 0. 066 0. 33 0. 029 0. 046 No Data No Data 5 0. 11 0. 13 0. 66 0. 059 0. 092 field­ grown ornamental trees 37 10 0. 16 0. 19 0. 97 0. 087 0. 14 No Data No Data 5 0. 32 0. 39 1. 9 0. 17 0. 27 field­ grown flowers & groundcover 29 10 0. 2 0. 25 1. 2 0. 11 0. 17 5 0. 4 0. 49 2. 5 0. 22 0. 35 field­ grown ornamental trees & shrubs ( inject) and flowers & groundcover 11 10 0. 53 0. 65 3. 3 0. 29 0. 46 5 1. 1 1. 3 6. 5 0. 58 0. 91 coffee trees 8.3 10 0. 7 0.86 4.3 0. 39 0. 6 5 1. 4 1. 7 8. 6 0. 77 1. 2 Christmas trees 78 10 0. 075 0. 092 0. 46 0. 041 0. 064 5 0. 15 0. 18 0. 92 0. 082 0. 13 Christmas trees ( SLN) 4. 5 10 1. 3 1. 6 8 0. 71 1. 1 5 2. 6 3. 2 16 1. 4 2. 2 Potted ornamentals 0. 2 lb ai/ day ­ 290 360 1800 160 250 Scoop and Bucket l ( Fipronil) ( 10) field­ grown ornamental shrubs 109 10 2 No Data 0. 016 No Data 9 0. 064 0. 32 0. 013 0. 015 5 0. 032 0. 13 0. 64 0. 026 0. 031 field­ grown ornamental trees 37 10 0. 047 0. 19 0. 95 0. 038 0. 045 5 0. 095 0. 38 1. 9 0. 076 0. 09 field­ grown flowers & groundcover 29 10 0. 06 0. 24 1. 2 0. 048 0. 057 5 0. 12 0. 48 2. 4 0. 097 0. 11 field­ grown ornamental trees & shrubs ( inject) and flowers & groundcover 11 10 0. 16 0. 64 3. 2 0. 13 0. 15 5 0. 32 1. 3 6. 4 0. 25 0. 3 coffee trees 8.3 10 0. 21 0. 84 4. 2 0.17 0.2 5 0. 42 1. 7 8. 4 0. 34 0. 4 Christmas trees 78 10 0. 022 0. 09 0. 45 0. 018 0. 021 14 Table 2 Occupational Handler Short­ Term Exposures and Risks with Personal Protective Equipment continued Exposure Scenario Crop Type Application Rate a Acres Treated b Dermal ( gloves) Unit Exposure c ( mg/ lb ai) Dermal ( gloves, double layers) Unit Exposure c ( mg/ lb ai) Dermal ( gloves) MOE d Dermal ( gloves, double layers) MOE d Inhalation ( respirator) Unit Exposure e ( ug/ lb ai) Inhalation ( no respirator) MOE f Inhalation ( respirator) MOE g Dermal ( gloves) + Inhalation ( no respirator) MOE h Dermal ( gloves) + Inhalation ( respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( no respirator) MOE h Dermal ( gloves, double layers) Inhalation ( respirator) MOE h 5 0. 045 0. 18 0. 9 0. 036 0. 043 Christmas trees ( SLN) 4. 5 10 0. 39 1. 6 7. 8 0. 31 0. 37 5 0. 78 3. 1 16 0. 62 0. 74 Potted ornamentals 0. 2 lb ai/ day ­ 88 350 1800 70 83 FLAGGER Flagging Aerial Spray Applications ( 11) tobacco 4 350 Not applicable 0. 01 double layers only; no gloves Not applicable 2. 5 ( no gloves) 0. 07 6. 4 32 Not applicable Not applicable 1. 8 no gloves) 2. 3 no gloves) asparagus ( SLN) , barley 1 350 10 no gloves) 26 130 7. 2 no gloves) 9. 3 no gloves) barley 1 1200 2. 9 no gloves) 7. 5 38 2. 1 ( no gloves) 2. 7 no gloves) wheat 0. 75 1200 3. 9 no gloves) 10 50 2. 8 no gloves) 3. 6 no gloves) sorghum 0. 5 1200 5. 8 no gloves) 15 75 4. 2 no gloves) 5. 4 no gloves) potatoes ( foliar) , sorghum 0. 5 350 20 no gloves) 51 260 14 no gloves) 19 no gloves) cotton ( SLN) 0. 2 350 50 no gloves) 130 640 36 no gloves) 46 no gloves) Flagging Granular Applications ( 12) tobacco 4 350 Not applicable 0. 0016 double layers only; no gloves Not applicable 16 no gloves) 0. 03 15 75 Not applicable Not applicable 7. 7 no gloves) 13 no gloves) potatoes ( soil) 3 350 21 ( no gloves) 20 100 10 no gloves) 17 no gloves) peas, lentils 2.5 350 25 gloves) 24 120 12 no gloves) 21 no gloves) peanuts ( SLN) 2 350 31 ( no gloves) 30 150 15 no gloves) 26 no gloves) clover grown for seed ( SLN) , barley, sorghum, wheat 1 350 63 no gloves) 60 300 31 no gloves) 52 no gloves) barley, sorghum, wheat 1 1200 18 no gloves) 18 88 8. 9 no gloves) 15 no gloves) + ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( no ( ( ( ( ( ( ( ( ( ( Footnotes: a Application rates are based on maximum values found on various labels or proposed by registrant. In most scenarios, a range of maximum application rates is used to represent the range of rates for different crops/ sites/ uses. Most application rates upon which the analysis is based are presented as lb ai/ A. In the case of ornamentals in pots, the application rate is presented as lb ai/ day) . Specific application rates and the corresponding EPA Reg. numbers that are intended as examples of each exposure assessment scenario are presented in the table indicating risks at baseline attire. 15 Table 2 Occupational Handler Short­ Term Exposures and Risks with Personal Protective Equipment continued b Amount handled per day values are based on HED Exposure SAC Policy # 009 Standard Values for Daily Acres Treated in Agriculture, revised June 23, 2000, or best professional judgment when data is not available. c Unless otherwise footnoted, personal protective equipment dermal unit exposure values are from PHED Surrogate Exposure Guide, draft version August, 1998. PPE dermal exposure assumes long pants, long sleeved shirt, plus gloves and/ or double­ layer body protection; open mixing/ loading, open cab/ tractor. ( See Exposure Scenarios Descriptions Table for further information. ) d Short­ term dermal MOE = NOAEL ( 0. 5 mg/ kg/ day / short­ term PPE daily dermal dose ( mg/ kg/ day) , where daily dermal dose = [ unit dermal exposure ( mg/ lb ai) * application rate ( lb ai/ acre) * daily acres treated * dermal absorption ( 100% ) ] / body weight ( 70 kg) . [ Note: application rate and acres treated/ day are replaced by pounds handled per day for ornamentals in pots scenario. ] Uncertainty Factor = 100. e Unless otherwise footnoted, personal protective equipment inhalation unit exposure values are from PHED Surrogate Exposure Guide, draft version August, 1998 representing use of a dust mist respirator ­ ­ calculated using an 80% protection factor from baseline inhalation exposure values. f Baseline Inhalation MOE from table indicating risks at baseline attire ( no respirator) g PPE Inhalation MOE = NOAEL ( 0. 045 mg/ kg/ day) / PPE inhalation dose, where daily PPE inhalation dose = ( unit exposure ( F g/ lb ai) * ( 1mg/ 1000 F g) conversion * appl. rate ( lb ai/ A) * acres treated/ day) / body weight ( 70 kg) [ Note: application rate and acres treated/ day are replaced by pounds handled per day for ornamentals in pots scenario. ] Uncertainty Factor = 100. h Total PPE Short­ term MOE = 1 1 1 % dermal MOE inhalation MOE i Unit exposure values from Outdoor Residential Exposure Task Force study: ORETF Study Number OMA001. Exposure of Professional Lawn Care Workers During the Mixing, Loading and Application of Granular Turf Pesticides Utilizing a Surrogate Compound . Values from EPA memo dated April 30, 2001 using same standard PPE assumptions as for PHED ( footnotes c and e) . Geometric mean is used for dermal values and median is used for inhalation value. j Unit exposure values from a loader/ applicator study using passive dosimetry and pump­ feed backpack equipment to load and apply aldicarb granules to the soil at the base of banana trees. MRID # 451672­ 01 Worker Exposure Study During Application in Banana Plantation with Temik 10G . Applicators wore baseline attire plus Tyvek gloves and a back apron. Geometric mean is used for dermal and inhalation values. k Unit exposure values from a loader/ applicator study using passive dosimetry and gravity­ feed backpack equipment to load and apply fipronil granules to the soil at the base of banana trees. MRID # 452507­ 02 Worker Exposure Study During Application of Regent 10GR in Banana Plantation. Applicators wore baseline attire plus PVC gloves. Geometric mean is used for dermal and inhalation values. l Unit exposure values from a loader/ applicator study using passive dosimetry and handheld bucket and scoop equipment to load and apply fipronil granules to the soil at the base of banana trees. MRID # 452507­ 02 Worker Exposure Study During Application of Regent 10GR in Banana Plantation. Applicators wore baseline attire plus PVC gloves. Geometric mean is used for dermal and inhalation values. 16 Table 3: Occupational Handler Intermediate­ Term Exposures and Risks with Personal Protective Equipment Exposure Scenario Crop Type Application Rate a Acres Treated b Dermal ( gloves) Unit Exposure c ( mg/ lb ai) Dermal ( gloves, double layers) Unit Exposure c ( mg/ lb ai) Dermal ( gloves) MOE d Dermal ( gloves, double layers) MOE d Inhalation ( respirator) Unit Exposure e ( ug/ lb ai) Inhalation ( baseline) MOE f Inhalation ( respirator) MOE g Dermal ( gloves) + Inhalation ( baseline) MOE h Dermal ( gloves) + Inhalation ( respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( baseline) MOE h Dermal ( gloves, double layers) + Inhalation ( respirator) MOE h MIXER/ LOADER Mixing/ Loading Liquid Formulations for Aerial Application ( 1a) tobacco 4 350 0.023 0.017 0.18 0.25 0.24 1.9 9. 4 0.17 0.18 0.22 0.24 asparagus ( SLN) 1 350 0. 72 0. 98 7. 5 38 0. 66 0. 71 0. 87 0. 96 barley 1 1200 0. 21 0. 29 2. 2 11 0. 19 0. 21 0. 25 0. 28 wheat 0. 75 1200 0. 28 0. 38 2. 9 15 0. 26 0. 28 0. 34 0. 37 sorghum 0. 5 1200 0. 42 0. 57 4. 4 22 0. 39 0. 41 0. 51 0. 56 potatoes ( foliar) 0. 5 350 1. 4 2 15 75 1. 3 1. 4 1. 7 1. 9 cotton ( SLN) 0. 2 1200 1. 1 1. 4 11 55 0. 96 1 1. 3 1. 4 Mixing/ Loading Liquid Formulations for Chemigation Application ( 1b) potatoes ( foliar) ­ OR, WA, ID, UT 3 350 0. 24 0. 33 2. 5 13 0. 22 0. 24 0. 29 0. 32 poplars grown for pulpwood ( SLN) 3 350 0. 24 0. 33 2. 5 13 0. 22 0. 24 0. 29 0. 32 cabbage, lettuce 2 350 0. 36 0. 49 3. 8 19 0. 33 0. 36 0. 43 0. 48 broccoli, brussels sprouts, cauliflower, cotton 1 350 0. 72 0. 98 7. 5 38 0. 66 0. 71 0. 87 0. 96 Mixing/ Loading Liquid Formulations for Groundboom Application ( 1c) tobacco 4 80 0. 79 1. 1 8.2 41 0. 72 0. 78 0. 95 1 poplars grown for pulpwood ( SLN) 3 80 1. 1 1. 4 11 55 0. 96 1 1. 3 1. 4 potatoes ( soil) 3 80 1. 1 1. 4 11 55 0. 96 1 1. 3 1. 4 peas, lentils 2.5 80 1. 3 1.7 13 66 1. 2 1.2 1. 5 1.7 beans( dry, snap, lima) , lettuce, peppers, radish grown for seed, cabbage 2 80 1. 6 2. 1 16 82 1. 4 1. 6 1. 9 2. 1 wheat, barley, cotton, sorghum 1 200 1. 3 1. 7 13 66 1. 2 1. 2 1. 5 1. 7 asparagus ( SLN) , broccoli, brussels sprouts, cauliflower 1 80 0. 023 0. 017 3. 2 4. 3 0. 24 33 160 2. 9 3. 1 3. 8 4. 2 potatoes ( foliar) 0. 5 80 6. 3 8. 6 66 330 5. 8 6. 2 7. 6 8. 4 17 Table 3: Occupational Handler Intermediate­ Term Exposures and Risks with Personal Protective Equipment continued Exposure Scenario Crop Type Application Rate a Acres Treated b Dermal ( gloves) Unit Exposure c ( mg/ lb ai) Dermal ( gloves, double layers) Unit Exposure c ( mg/ lb ai) Dermal ( gloves) MOE d Dermal ( gloves, double layers) MOE d Inhalation ( respirator) Unit Exposure e ( ug/ lb ai) Inhalation ( baseline) MOE f Inhalation ( respirator) MOE g Dermal ( gloves) + Inhalation ( baseline) MOE h Dermal ( gloves) + Inhalation ( respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( baseline) MOE h Dermal ( gloves, double layers) + Inhalation ( respirator) MOE h Loading Granular Formulations for Aerial Application ( 2a) tobacco 4 350 0.0069 0.0034 0.6 1. 2 0.34 1.3 6. 6 0.41 0.55 0.64 1 potatoes ( soil) 3 350 0. 81 1. 6 1. 8 8. 8 0. 55 0. 74 0. 85 1. 4 peas, lentils 2.5 350 0.97 2 2. 1 11 0.66 0.89 1 1. 7 peanuts ( SLN) 2 350 1. 2 2. 5 2. 6 13 0. 83 1. 1 1. 3 2. 1 clover grown for seed ( SLN) 1 350 2. 4 4. 9 5. 3 26 1. 7 2. 2 2. 5 4. 1 barley, sorghum, wheat 1 1200 0. 7 1. 4 1. 5 7. 7 0. 48 0. 65 0. 74 1. 2 Loading Granular Formulations for Ground Application ( 2b) field­ grown ornamental shrubs 109 40 0. 19 0. 39 0. 42 2. 1 0. 13 0. 18 0. 2 0. 33 field­ grown ornamental trees 37 40 0. 57 1. 2 1. 3 6. 3 0. 39 0. 52 0. 6 0. 98 field­ grown flowers & groundcover 29 40 0. 73 1. 5 1. 6 8 0. 5 0. 67 0. 77 1. 2 field­ grown ornamental trees and shrubs ( inject) and flowers & groundcover 11 40 1. 9 3. 9 4. 2 21 1. 3 1. 8 2 3. 3 coffee trees 8. 3 80 1. 3 2. 6 2. 8 14 0. 87 1. 2 1. 3 2. 2 Christmas trees 78 50 0. 22 0. 44 0. 48 2. 4 0. 15 0. 2 0. 23 0. 37 Christmas trees ( SLN) 4. 5 50 3. 8 7. 6 8. 2 41 2. 6 3. 4 4 6. 4 tobacco 4 80 2. 6 5.4 5. 8 29 1.8 2. 4 2.8 4. 5 potatoes ( soil) 3 80 3. 5 7. 1 7. 7 39 2. 4 3. 2 3. 7 6 peas, lentils 2.5 80 4. 2 8.6 9. 3 46 2.9 3. 9 4.5 7. 2 peppers, peanuts ( SLN) , radish grown for seed ( SLN) 2 80 5. 3 11 0. 34 12 58 3. 6 4. 8 5. 6 9 cabbage 1. 5 80 7 14 15 77 4. 8 6. 5 7. 4 12 barley, cotton, sorghum, soybeans, wheat 1 200 4. 2 8. 6 9. 3 46 2. 9 3. 9 4. 5 7. 2 18 Table 3: Occupational Handler Intermediate­ Term Exposures and Risks with Personal Protective Equipment continued Exposure Scenario Crop Type Application Rate a Acres Treated b Dermal ( gloves) Unit Exposure c ( mg/ lb ai) Dermal ( gloves, double layers) Unit Exposure c ( mg/ lb ai) Dermal ( gloves) MOE d Dermal ( gloves, double layers) MOE d Inhalation ( respirator) Unit Exposure e ( ug/ lb ai) Inhalation ( baseline) MOE f Inhalation ( respirator) MOE g Dermal ( gloves) + Inhalation ( baseline) MOE h Dermal ( gloves) + Inhalation ( respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( baseline) MOE h Dermal ( gloves, double layers) + Inhalation ( respirator) MOE h peanuts, beans ( dry, snap, lima) , brussels sprout, cauliflower, broccoli, clover grown for seed ( SLN) 1 80 11 21 23 120 7. 3 9. 7 11 18 APPLICATOR Applying Sprays with an Airplane ( 3) tobacco 4 350 No Data See Engineering Controls asparagus ( SLN) 1 350 barley 1 1200 wheat 0. 75 1200 sorghum 0. 5 1200 potatoes ( foliar) 0. 5 350 cotton ( SLN) 0. 2 1200 Applying Granulars with an Airplane ( 4) tobacco 4 350 No Data See Engineering Controls potatoes ( soil) 3 350 peas, lentils 2.5 350 peanuts ( SLN) 2 350 barley, sorghum, wheat 1 1200 clover grown for seed ( SLN) 1 350 Applying with a Groundboom ( 5) tobacco 4 80 0. 014 0.011 1.3 1. 7 0.15 13 66 1.2 1. 3 1.5 1. 6 poplars grown for pulpwood ( SLN) 3 80 1. 7 2. 2 18 88 1. 6 1. 7 2 2. 2 potatoes ( soil) 3 80 1. 7 2. 2 0. 15 18 88 1. 6 1. 7 2 2. 2 peas, lentils 2.5 80 2. 1 2.7 21 110 1.9 2 2.4 2. 6 beans( dry, snap, lima) , lettuce, peppers, radish grown for seed, cabbage 2 80 2. 6 3. 3 0. 15 27 130 2. 4 2. 6 2. 9 3. 2 wheat, barley, cotton, sorghum 1 200 2. 1 2. 7 21 110 1. 9 2 2. 4 2. 6 19 Table 3: Occupational Handler Intermediate­ Term Exposures and Risks with Personal Protective Equipment continued Exposure Scenario Crop Type Application Rate a Acres Treated b Dermal ( gloves) Unit Exposure c ( mg/ lb ai) Dermal ( gloves, double layers) Unit Exposure c ( mg/ lb ai) Dermal ( gloves) MOE d Dermal ( gloves, double layers) MOE d Inhalation ( respirator) Unit Exposure e ( ug/ lb ai) Inhalation ( baseline) MOE f Inhalation ( respirator) MOE g Dermal ( gloves) + Inhalation ( baseline) MOE h Dermal ( gloves) + Inhalation ( respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( baseline) MOE h Dermal ( gloves, double layers) + Inhalation ( respirator) MOE h asparagus ( SLN) , broccoli, brussels sprouts, cauliflower 1 80 5. 2 6. 6 53 260 4. 7 5. 1 5. 9 6. 5 potatoes ( foliar) 0. 5 80 10 13 110 530 9. 5 10 12 13 Applying Granulars with a Tractor Drawn Spreader ( 6) field­ grown ornamental shrubs 109 40 0. 0072 0. 0042 0. 19 0. 32 0. 24 0. 6 3 0. 14 0. 18 0. 21 0. 29 field­ grown ornamental trees 37 40 0. 55 0. 94 1. 8 8. 9 0. 42 0. 52 0. 61 0. 85 field­ grown flowers & groundcover 29 40 0. 7 1. 2 2. 3 11 0. 53 0. 66 0. 78 1. 1 field­ grown ornamental trees & shrubs ( inject) and flowers & groundcover 11 40 1. 8 3. 2 6 30 1. 4 1. 7 2. 1 2. 9 coffee trees 8. 3 80 1. 2 2. 1 4 20 0. 93 1. 1 1. 4 1. 9 Christmas trees 78 50 0. 21 0. 36 0. 67 3. 4 0. 16 0. 2 0. 23 0. 32 Christmas trees ( SLN) 4. 5 50 3. 6 6. 2 12 58 2. 8 3. 4 4 5. 6 tobacco 4 80 2. 5 4.3 8. 2 41 1.9 2. 4 2.8 3. 9 potatoes ( soil) 3 80 3. 4 5. 8 11 55 2. 6 3. 2 3. 8 5. 2 peas, lentils 2.5 80 4. 1 6.9 13 66 3. 1 3.8 4. 5 6.3 peppers, peanuts ( SLN) , radish grown for seed ( SLN) 2 80 5. 1 8. 7 16 82 3. 9 4. 8 5. 7 7. 8 cabbage 1. 5 80 6. 8 12 22 110 5. 2 6. 4 7. 6 10 barley, cotton, sorghum, soybeans, wheat 1 200 4. 1 6. 9 13 66 3. 1 3. 8 4. 5 6. 3 peanuts, beans ( dry, snap, lima) , brussels sprout, cauliflower, broccoli, clover grown for seed­ SLN 1 80 10 17 33 160 7. 7 9. 5 11 16 20 Table 3: Occupational Handler Intermediate­ Term Exposures and Risks with Personal Protective Equipment continued Exposure Scenario Crop Type Application Rate a Acres Treated b Dermal ( gloves) Unit Exposure c ( mg/ lb ai) Dermal ( gloves, double layers) Unit Exposure c ( mg/ lb ai) Dermal ( gloves) MOE d Dermal ( gloves, double layers) MOE d Inhalation ( respirator) Unit Exposure e ( ug/ lb ai) Inhalation ( baseline) MOE f Inhalation ( respirator) MOE g Dermal ( gloves) + Inhalation ( baseline) MOE h Dermal ( gloves) + Inhalation ( respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( baseline) MOE h Dermal ( gloves, double layers) + Inhalation ( respirator) MOE h MIXER/ LOADER/ APPLICATOR Loading/ Applying with a Push Type Spreader i ( ORETF) ( 7) field­ grown ornamental shrubs 109 5 0. 22 0. 11 0. 049 0. 097 1. 5 0. 77 3. 9 0. 046 0. 048 0. 086 0. 095 field­ grown ornamental trees 37 5 0. 14 0. 29 2. 3 11 0. 13 0. 14 0. 25 0. 28 field­ grown flowers & groundcover 29 5 0. 18 0. 37 2. 9 14 0. 17 0. 18 0. 32 0. 36 field­ grown ornamental trees & shrubs ( inject) and flowers & groundcover 11 5 0. 48 0. 96 7. 6 38 0. 45 0. 48 0. 86 0. 94 Christmas trees 78 5 0. 068 0. 14 1. 1 5. 4 0. 064 0. 067 0. 12 0. 13 Christmas trees ( SLN) 4. 5 5 1. 2 2. 4 19 93 1. 1 1. 2 2. 1 2. 3 Loading/ Applying with a Bellygrinder ( PHED) ( 8) field­ grown ornamental shrubs 109 1 9. 3 5. 7 0. 0058 0. 0094 12 0. 47 2. 4 0. 0057 0. 0057 0. 0092 0. 0094 field­ grown ornamental trees 37 1 0. 017 0. 028 1. 4 7. 1 0. 017 0. 017 0. 027 0. 028 field­ grown flowers & groundcover 29 1 0. 022 0. 035 12 1. 8 9. 1 0. 021 0. 022 0. 035 0. 035 field­ grown ornamental trees & shrubs ( inject) and flowers & groundcover 11 1 0. 057 0. 093 4. 6 24 0. 056 0. 057 0. 091 0. 093 Christmas trees 78 1 0. 008 0. 013 0. 65 3. 4 0. 0079 0. 008 0. 013 0. 013 Christmas trees ( SLN) 4. 5 1 0. 14 0. 23 11 58 0. 14 0. 14 0. 22 0. 23 Loading/ Applying Granulars with a Pump­ Feed Backpack Spreader j ( Aldicarb) ( 9a) field­ grown ornamental shrubs 109 10 0. 01 No Data 0. 54 No Data 0. 84 0. 69 3. 4 0. 3 ( apron) 0. 46 ( apron) No Data No Data 5 1. 1 1. 4 6. 9 0. 6 ( apron) 0. 93 ( apron) field­ grown ornamental trees 37 10 1. 6 2 10 0. 89 ( apron) 1. 4 ( apron) 5 3. 2 4. 1 20 1. 8 ( apron) 2. 7 ( apron) field­ grown flowers & groundcover 29 10 2 2. 6 13 1. 1 ( apron) 1. 7 ( apron) 5 4 5. 2 26 2. 3 ( apron) 3. 5 ( apron) 21 ­ Table 3: Occupational Handler Intermediate­ Term Exposures and Risks with Personal Protective Equipment continued Exposure Scenario Crop Type Application Rate a Acres Treated b Dermal ( gloves) Unit Exposure c ( mg/ lb ai) Dermal ( gloves, double layers) Unit Exposure c ( mg/ lb ai) Dermal ( gloves) MOE d Dermal ( gloves, double layers) MOE d Inhalation ( respirator) Unit Exposure e ( ug/ lb ai) Inhalation ( baseline) MOE f Inhalation ( respirator) MOE g Dermal ( gloves) + Inhalation ( baseline) MOE h Dermal ( gloves) + Inhalation ( respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( baseline) MOE h Dermal ( gloves, double layers) + Inhalation ( respirator) MOE h field­ grown ornamental trees & shrubs ( inject) and flowers & groundcover 11 10 5. 3 6. 8 34 3 ( apron) 4. 6 ( apron) 5 11 14 68 6 ( apron) 9. 2 ( apron) coffee trees 8. 3 10 7 9 45 4 ( apron) 6. 1 ( apron) 5 14 18 90 7. 9 ( apron) 12 ( apron) Christmas trees 78 10 0. 75 0. 96 4. 8 0. 42 0. 65 5 1. 5 1. 9 9. 6 0. 84 1. 3 Christmas trees ( SLN) 4. 5 10 13 17 83 7. 3 11 5 26 33 170 15 22 Potted ornamentals 0. 2 lb ai/ day 2900 3800 19000 1600 2500 22 ­ Table 3: Occupational Handler Intermediate­ Term Exposures and Risks with Personal Protective Equipment continued Exposure Scenario Crop Type Application Rate a Acres Treated b Dermal ( gloves) Unit Exposure c ( mg/ lb ai) Dermal ( gloves, double layers) Unit Exposure c ( mg/ lb ai) Dermal ( gloves) MOE d Dermal ( gloves, double layers) MOE d Inhalation ( respirator) Unit Exposure e ( ug/ lb ai) Inhalation ( baseline) MOE f Inhalation ( respirator) MOE g Dermal ( gloves) + Inhalation ( baseline) MOE h Dermal ( gloves) + Inhalation ( respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( baseline) MOE h Dermal ( gloves, double layers) + Inhalation ( respirator) MOE h Loading/ Applying Granular with a Gravity­ Feed Backpack Spreader k ( Fipronil) ( 9b) field­ grown ornamental shrubs 109 10 0. 6 No Data 0. 0089 No Data 8. 8 0. 066 0. 33 0. 0079 0. 0087 No Data No Data 5 0. 018 0. 13 0. 66 0. 016 0. 017 field­ grown ornamental trees 37 10 0. 026 0. 19 0. 97 0. 023 0. 026 5 0. 053 0. 39 1. 9 0. 046 0. 051 field­ grown flowers & groundcover 29 10 0. 034 0. 25 1. 2 0. 03 0. 033 No Data No Data 5 0. 067 0. 49 2. 5 0. 059 0. 065 field­ grown ornamental trees & shrubs ( inject) and flowers & groundcover 11 10 0. 088 0. 65 3. 3 0. 078 0. 086 5 0. 18 1. 3 6. 5 0. 16 0. 17 coffee trees 8.3 10 0. 12 0. 86 4. 3 0.1 0. 11 5 0. 23 1. 7 8. 6 0. 21 0. 23 Christmas trees 78 10 0. 012 0. 092 0. 46 0. 011 0. 012 5 0. 025 0. 18 0. 92 0. 022 0. 024 Christmas trees ( SLN) 4. 5 10 0. 22 1. 6 8 0. 19 0. 21 5 0. 43 3. 2 16 0. 38 0. 42 Potted ornamentals 0. 2 lb ai/ day 49 360 1800 43 47 23 ­ Table 3: Occupational Handler Intermediate­ Term Exposures and Risks with Personal Protective Equipment continued Exposure Scenario Crop Type Application Rate a Acres Treated b Dermal ( gloves) Unit Exposure c ( mg/ lb ai) Dermal ( gloves, double layers) Unit Exposure c ( mg/ lb ai) Dermal ( gloves) MOE d Dermal ( gloves, double layers) MOE d Inhalation ( respirator) Unit Exposure e ( ug/ lb ai) Inhalation ( baseline) MOE f Inhalation ( respirator) MOE g Dermal ( gloves) + Inhalation ( baseline) MOE h Dermal ( gloves) + Inhalation ( respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( baseline) MOE h Dermal ( gloves, double layers) + Inhalation ( respirator) MOE h Scoop and Bucket l ( Fipronil) ( 10) field­ grown ornamental shrubs 109 10 2 No Data 0. 0027 No Data 9 0. 064 0. 32 0. 0026 0. 0027 No Data No Data 5 0. 0054 0. 13 0. 64 0. 0051 0. 0053 field­ grown ornamental trees 37 10 0. 0079 0. 19 0. 95 0. 0076 0. 0078 5 0. 016 0. 38 1. 9 0. 015 0. 016 field­ grown flowers & groundcover 29 10 0. 01 0. 24 1. 2 0. 0097 0. 01 5 0. 02 0. 48 2. 4 0. 019 0. 02 field­ grown ornamental trees & shrubs ( inject) and flowers & groundcovers 11 10 0. 027 0. 64 3. 2 0. 025 0. 026 5 0. 053 1. 3 6. 4 0. 051 0. 053 coffee trees 8. 3 10 0. 035 0. 84 4. 2 0. 034 0. 035 5 0. 07 1. 7 8. 4 0. 067 0. 07 Christmas trees 78 10 0. 0037 0. 09 0. 45 0. 0036 0. 0037 5 0. 0075 0. 18 0. 9 0. 0072 0. 0074 Christmas trees ( SLN) 4. 5 10 0. 065 1. 6 7. 8 0. 062 0. 064 5 0. 13 3. 1 16 0. 12 0. 13 Potted ornamentals 0. 2 lb ai/ day 15 350 1800 14 14 FLAGGER Flagging Aerial Spray Applications ( 11) tobacco 4 350 not applicable 0. 01 double layers only; no gloves not applicable 0. 42 ( no gloves) 0. 07 6. 4 32 not applicable not applicable 0. 39 ( no gloves) 0. 41 ( no gloves) asparagus ( SLN) , barley 1 350 1. 7 ( no gloves) 26 130 1. 6 ( no gloves) 1. 6 ( no gloves) barley 1 1200 0. 49 ( no gloves) 7. 5 38 0. 46 ( no gloves) 0. 48 ( no gloves) wheat 0. 75 1200 0. 65 ( no gloves) 10 50 0. 61 ( no gloves) 0. 64 ( no gloves) sorghum 0. 5 1200 0. 97 ( no gloves) 15 75 0. 91 ( no gloves) 0. 96 ( no gloves) potatoes ( foliar) 0. 5 350 3. 3 ( no gloves) 51 260 3. 1 ( no gloves) 3. 3 ( no gloves) cotton ( SLN) 0. 2 350 8. 3 ( no gloves) 130 640 7. 8 ( no gloves) 8. 2 ( no gloves) 24 Table 3: Occupational Handler Intermediate­ Term Exposures and Risks with Personal Protective Equipment continued Exposure Scenario Crop Type Application Rate a Acres Treated b Dermal ( gloves) Unit Exposure c ( mg/ lb ai) Dermal ( gloves, double layers) Unit Exposure c ( mg/ lb ai) Dermal ( gloves) MOE d Dermal ( gloves, double layers) MOE d Inhalation ( respirator) Unit Exposure e ( ug/ lb ai) Inhalation ( baseline) MOE f Inhalation ( respirator) MOE g Dermal ( gloves) + Inhalation ( baseline) MOE h Dermal ( gloves) + Inhalation ( respirator) MOE h Dermal ( gloves, double layers) + Inhalation ( baseline) MOE h Dermal ( gloves, double layers) + Inhalation ( respirator) MOE h Flagging Granular Applications ( 12) tobacco 4 350 not applicable 0. 0016 double layers only; no gloves not applicable 2. 6 0. 03 15 75 not applicable not applicable 2. 2 ( no gloves) 2. 5 ( no gloves) potatoes ( soil) 3 350 3. 5 20 100 3 ( no gloves) 3. 4 ( no gloves) peas, lentils 2.5 350 4.2 24 120 3.6 ( no gloves) 4 ( no gloves) peanuts ( SLN) 2 350 5. 2 30 150 4. 4 ( no gloves) 5 ( no gloves) clover grown for seed ( SLN) , barley, sorghum, wheat 1 350 10 60 300 8. 9 ( no gloves) 10 ( no gloves) barley, sorghum, wheat 1 1200 3 18 88 2. 6 ( no gloves) 2. 9 ( no gloves) Footnotes: a Application rates are based on maximum values found on various labels or proposed by registrant. In most scenarios, a range of maximum application rates is used to represent the range of rates for different crops/ sites/ uses. Most application rates upon which the analysis is based are presented as lb ai/ A. In the case of ornamentals in pots, the application rate is presented as lb ai/ day) . Specific application rates and the corresponding EPA Reg. numbers that are intended as examples of each exposure assessment scenario are presented in the table indicating risks at baseline attire. b Amount handled per day values are based on HED Exposure SAC Policy # 009 Standard Values for Daily Acres Treated in Agriculture, revised June 23, 2000, or best professional judgment when data is not available. c Unless otherwise footnoted, personal protective equipment dermal unit exposure values are from PHED Surrogate Exposure Guide, draft version August, 1998. PPE dermal exposure assumes long pants, long sleeved shirt, plus gloves and/ or double­ layer body protection; open mixing/ loading, open cab/ tractor. ( See Exposure Scenarios Descriptions Table for further information. ) d Intermediate­ term dermal MOE = NOAEL ( 0. 03 mg/ kg/ day / intermediate­ term PPE daily dermal dose ( mg/ kg/ day) , where daily dermal dose = [ unit dermal exposure ( mg/ lb ai) * application rate ( lb ai/ acre) * daily acres treated * dermal absorption ( 36% ) ] / body weight ( 70 kg) . [ Note: application rate and acres treated/ day are replaced by pounds handled per day for ornamentals in pots scenario. ] Uncertainty Factor = 100. e Unless otherwise footnoted, personal protective equipment inhalation unit exposure values are from PHED Surrogate Exposure Guide, draft version August, 1998 representing use of a dust mist respirator ­ ­ calculated using an 80% protection factor from baseline inhalation exposure values. f Baseline inhalation MOE from table indicating risks at baseline attire ( no respirator) g PPE Inhalation MOE = NOAEL ( 0. 045 mg/ kg/ day) / PPE inhalation dose, where daily PPE inhalation dose = ( unit exposure ( F g/ lb ai) * ( 1mg/ 1000 F g) conversion * appl. rate ( lb ai/ A) * acres treated/ day) / body weight ( 70 kg) [ Note: application rate and acres treated/ day are replaced by pounds handled per day for ornamentals in pots scenario. ] Uncertainty Factor = 100. h Total PPE Intermediate­ term MOE = 1 1 1 % dermal MOE inhalation MOE i Unit exposure values from Outdoor Residential Exposure Task Force study: ORETF Study Number OMA001. Exposure of Professional Lawn Care Workers During the Mixing, Loading and Application of Granular Turf Pesticides Utilizing a Surrogate Compound . Values from EPA memo dated April 30, 2001 using same standard PPE assumptions as for PHED ( footnotes c and e) . Geometric mean is used for dermal values and median is used for inhalation value. j Unit exposure values from a loader/ applicator study using passive dosimetry and pump­ feed backpack equipment to load and apply aldicarb granules to the soil at the base of banana trees. MRID # 451672­ 01 Worker Exposure Study During Application in Banana Plantation with Temik 10G . Applicators wore baseline attire plus Tyvek gloves and a back apron. Geometric mean is used for dermal and inhalation values. k Unit exposure values from a loader/ applicator study using passive dosimetry and gravity­ feed backpack equipment to load and apply fipronil granules to the soil at the base of banana trees. MRID # 452507­ 02 Worker Exposure Study During Application of Regent 10GR in Banana Plantation. Applicators wore baseline attire plus PVC gloves. Geometric mean is used for dermal and inhalation values. Unit exposure values from a loader/ applicator study using passive dosimetry and handheld bucket and scoop equipment to load and apply fipronil granules to the soil at the base of banana trees. MRID # 452507­ 02 Worker Exposure Study During Application of Regent 10GR in Banana Plantation. Applicators wore baseline attire plus PVC gloves. Geometric mean is used for dermal and inhalation values. 25 Table 4: Occupational Handler Short­ and Intermediate­ Term Exposures and Risks with Engineering Controls Exposure Scenario Crop Type Application Rate a Acres Treated b Dermal Engineering Control Unit Exposure c ( mg/ lb ai) Inhalation Engineering Control Unit Exposure d ( ug/ lb ai) Short­ Term Dermal Engineering Control MOE e Intermediate­ Term Dermal Engineering Control MOE f Baseline Inhalation ( no respirator) MOE g Inhalation Engineering Control MOE h Combined Short­ Term Eng. Control Dermal + Eng. Control Inhalation MOE i Combined Interm­ Term Eng. Control Dermal + Eng Control Inhalation MOE i Combined Short­ Term Eng. Control Dermal + Baseline Inhalation MOE i Combined Interm Term Eng. Control Dermal + Baseline Inhalation MOE i MIXER/ LOADER Mixing/ Loading Liquid Formulations for Aerial Application ( 1a) tobacco 4 350 0.0086 0.083 2.9 0. 48 1. 9 27 2.6 0. 48 1. 1 0.39 asparagus ( SLN) 1 350 12 1. 9 7. 5 110 11 1. 9 4. 6 1. 5 barley 1 1200 3. 4 0. 57 2. 2 32 3. 1 0. 56 1. 3 0. 45 wheat 0. 75 1200 4. 5 0. 75 2. 9 42 4. 1 0. 74 1. 8 0. 6 sorghum 0. 5 1200 6. 8 1. 1 4. 4 63 6. 1 1. 1 2. 7 0. 9 potatoes ( foliar) 0. 5 350 23 3. 9 15 220 21 3. 8 9. 1 3. 1 cotton ( SLN) 0. 2 1200 17 2. 8 11 160 15 2. 8 6. 6 2. 2 Mixing/ Loading Liquid Formulations for Chemigation Application ( 1b) potatoes ( foliar) ­ OR, WA, ID, UT 3 350 3. 9 0. 65 2. 5 36 3. 5 0. 63 1. 5 0. 51 poplars grown for pulpwood ( SLN) 3 350 3. 9 0. 65 2. 5 36 3. 5 0. 63 1. 5 0. 51 cabbage, lettuce 2 350 5. 8 0. 97 3. 8 54 5. 3 0. 95 2. 3 0. 77 broccoli, brussels sprouts, cauliflower, cotton 1 350 12 1. 9 7. 5 110 11 1. 9 4. 6 1. 5 Mixing/ Loading Liquid Formulations for Groundboom Application ( 1c) tobacco 4 80 13 2. 1 8.2 120 11 2.1 5 1.7 poplars grown for pulpwood ( SLN) 3 80 17 2. 8 11 160 15 2. 8 6. 6 2. 2 potatoes ( soil) 3 80 17 2. 8 11 160 15 2. 8 6. 6 2. 2 peas, lentils 2.5 80 20 3. 4 13 190 18 3.3 8 2.7 beans ( dry, snap, lima) , lettuce, peppers, radish grown for seed, cabbage 2 80 25 4. 2 16 240 23 4. 2 10 3. 4 wheat, barley, cotton, sorghum 1 200 20 3. 4 13 190 18 3. 3 8 2. 7 asparagus ( SLN) , broccoli, brussels sprouts, cauliflower 1 80 51 8. 5 33 470 46 8. 3 20 6. 7 potatoes ( foliar) 0. 5 80 100 17 66 950 92 17 40 13 26 Table 4: Occupational Handler Short­ and Intermediate­ Term Exposures and Risks with Engineering Controls continued Exposure Scenario Crop Type Application Rate a Acres Treated b Dermal Engineering Control Unit Exposure c ( mg/ lb ai) Inhalation Engineering Control Unit Exposure d ( ug/ lb ai) Short­ Term Dermal Engineering Control MOE e Intermediate­ Term Dermal Engineering Control MOE f Baseline Inhalation ( no respirator) MOE g Inhalation Engineering Control MOE h Combined Short­ Term Eng. Control Dermal + Eng. Control Inhalation MOE i Combined Interm­ Term Eng. Control Dermal + Eng Control Inhalation MOE i Combined Short­ Term Eng. Control Dermal + Baseline Inhalation MOE i Combined Interm Term Eng. Control Dermal + Baseline Inhalation MOE i Loading Granular Formulations for Aerial Application ( 2a) tobacco 4 350 0.00017 0.034 150 25 1.3 66 46 18 NF NF potatoes ( soil) 3 350 200 33 1. 8 88 61 24 NF NF peas, lentils 2.5 350 240 39 2.1 110 73 29 NF NF peanuts ( SLN) 2 350 290 49 2. 6 130 91 36 NF NF clover grown for seed ( SLN) 1 350 590 98 5. 3 260 180 72 NF NF barley, sorghum, wheat 1 1200 170 29 1. 5 77 53 21 NF NF Loading Granular Formulations for Ground Application ( 2b) field­ grown ornamental shrubs 109 40 47 7. 9 0. 42 21 15 5. 7 NF NF field­ grown ornamental trees 37 40 140 23 1. 3 63 43 17 NF NF field­ grown flowers & groundcover 29 40 180 30 1. 6 80 55 22 NF NF field­ grown ornamental trees and shrubs ( inject) 11 40 470 78 4. 2 210 150 57 NF NF coffee trees 8. 3 80 310 52 2. 8 140 96 38 NF NF Christmas trees 78 50 53 8. 8 0. 48 24 16 6. 4 NF NF Christmas trees ( SLN) 4. 5 50 920 150 8. 2 410 280 110 NF NF tobacco 4 80 640 110 5.8 290 200 78 NF NF potatoes ( soil) 3 80 860 140 7. 7 390 270 100 NF NF peas, lentils 2.5 80 1000 170 9.3 460 320 130 NF NF peppers, peanuts ( SLN) , radish grown for seed ( SLN) 2 80 1300 210 12 580 400 160 NF NF cabbage 1. 5 80 1700 290 15 770 530 210 NF NF barley, cotton, sorghum, soybeans, wheat 1 200 1000 170 9. 3 460 320 130 NF NF 27 Table 4: Occupational Handler Short­ and Intermediate­ Term Exposures and Risks with Engineering Controls continued Exposure Scenario Crop Type Application Rate a Acres Treated b Dermal Engineering Control Unit Exposure c ( mg/ lb ai) Inhalation Engineering Control Unit Exposure d ( ug/ lb ai) Short­ Term Dermal Engineering Control MOE e Intermediate­ Term Dermal Engineering Control MOE f Baseline Inhalation ( no respirator) MOE g Inhalation Engineering Control MOE h Combined Short­ Term Eng. Control Dermal + Eng. Control Inhalation MOE i Combined Interm­ Term Eng. Control Dermal + Eng Control Inhalation MOE i Combined Short­ Term Eng. Control Dermal + Baseline Inhalation MOE i Combined Interm Term Eng. Control Dermal + Baseline Inhalation MOE i peanuts, beans ( dry, snap, lima) , brussels sprout, cauliflower, broccoli, clover grown for seed ( SLN) 1 80 2600 430 23 1200 800 310 NF NF APPLICATOR Applying Sprays with an Airplane ( 3) tobacco 4 350 0.005 0.068 5 0. 83 No Data 33 4.3 0. 81 No Data No Data asparagus ( SLN) 1 350 20 3. 3 130 17 3. 3 No Data No Data barley 1 1200 5. 8 0. 97 39 5. 1 0. 95 No Data No Data wheat 0. 75 1200 7. 8 1. 3 51 6. 8 1. 3 No Data No Data sorghum 0. 5 1200 12 1. 9 77 10 1. 9 No Data No Data potatoes ( foliar) 0. 5 350 40 6. 7 260 35 6. 5 No Data No Data cotton ( SLN) 0. 2 1200 29 4. 9 190 25 4. 7 No Data No Data Applying Granulars with an Airplane ( 4) tobacco 4 350 0.0017 1.3 15 2. 5 No Data 1.7 1. 5 1 No Data No Data potatoes ( soil) 3 350 20 3. 3 2. 3 2. 1 1. 4 No Data No Data peas, lentils 2.5 350 24 3.9 2. 8 2.5 1. 6 No Data No Data peanuts ( SLN) 2 350 29 4. 9 3. 5 3. 1 2 No Data No Data barley, sorghum, wheat 1 1200 17 2. 9 2 1. 8 1. 2 No Data No Data clover grown for seed ( SLN) 1 350 59 9. 8 6. 9 6. 2 4. 1 No Data No Data Applying with a Groundboom ( 5) tobacco 4 80 0. 005 0.043 22 3.6 13 230 20 3.6 8. 3 2.9 poplars grown for pulpwood ( SLN) 3 80 29 4. 9 18 310 27 4. 8 11 3. 8 potatoes ( soil) 3 80 29 4. 9 18 310 27 4. 8 11 3. 8 peas, lentils 2.5 80 35 5. 8 21 370 32 5.7 13 4. 6 beans( dry, snap, lima) , lettuce, > peppers, radish grown for seed, cabbage 2 80 44 7. 3 27 460 40 7. 2 17 5. 7 wheat, barley, cotton, sorghum 1 200 35 5. 8 21 370 32 5. 7 13 4. 6 28 Table 4: Occupational Handler Short­ and Intermediate­ Term Exposures and Risks with Engineering Controls continued Exposure Scenario Crop Type Application Rate a Acres Treated b Dermal Engineering Control Unit Exposure c ( mg/ lb ai) Inhalation Engineering Control Unit Exposure d ( ug/ lb ai) Short­ Term Dermal Engineering Control MOE e Intermediate­ Term Dermal Engineering Control MOE f Baseline Inhalation ( no respirator) MOE g Inhalation Engineering Control MOE h Combined Short­ Term Eng. Control Dermal + Eng. Control Inhalation MOE i Combined Interm­ Term Eng. Control Dermal + Eng Control Inhalation MOE i Combined Short­ Term Eng. Control Dermal + Baseline Inhalation MOE i Combined Interm Term Eng. Control Dermal + Baseline Inhalation MOE i asparagus ( SLN) , broccoli, brussels sprouts, cauliflower 1 80 88 15 53 920 80 14 33 11 potatoes ( foliar) 0. 5 80 180 29 110 1800 160 29 66 23 Applying Granulars with a Tractor Drawn Spreader ( 6) field­ grown ornamental shrubs 109 40 0. 0021 0. 22 3. 8 0. 64 0. 6 3. 3 1. 8 0. 53 0. 52 0. 31 field­ grown ornamental trees 37 40 11 1. 9 1. 8 9. 7 5. 2 1. 6 1. 5 0. 91 field­ grown flowers & groundcover 29 40 14 2. 4 2. 3 12 6. 6 2 2 1. 2 field­ grown ornamental trees & shrubs ( inject) and flowers & groundcover 11 40 38 6. 3 6 33 18 5. 3 5. 2 3. 1 coffee trees 8.3 80 25 4. 2 4 22 12 3. 5 3.4 2 Christmas trees 78 50 4. 3 0. 71 0. 67 3. 7 2 0. 6 0. 58 0. 35 Christmas trees ( SLN) 4. 5 50 74 12 12 64 34 10 10 6 tobacco 4 80 52 8. 7 8.2 45 24 7. 3 7.1 4. 2 potatoes ( soil) 3 80 69 12 11 60 32 9. 7 9. 4 5. 6 peas, lentils 2.5 80 83 14 13 72 39 12 11 6. 7 peppers, peanuts ( SLN) , radish grown for seed ( SLN) 2 80 100 17 16 89 48 15 14 8. 4 cabbage 1. 5 80 140 23 22 120 64 19 19 11 barley, cotton, sorghum, soybeans, wheat 1 200 83 14 13 72 39 12 11 6. 7 peanuts, beans ( dry, snap, lima) , brussels sprout, cauliflower, broccoli, clover grown for seed­ SLN 1 80 210 35 33 180 96 29 28 17 MIXER/ LOADER/ APPLICATOR 29 Table 4: Occupational Handler Short­ and Intermediate­ Term Exposures and Risks with Engineering Controls continued Exposure Scenario Crop Type Application Rate a Acres Treated b Dermal Engineering Control Unit Exposure c ( mg/ lb ai) Inhalation Engineering Control Unit Exposure d ( ug/ lb ai) Short­ Term Dermal Engineering Control MOE e Intermediate­ Term Dermal Engineering Control MOE f Baseline Inhalation ( no respirator) MOE g Inhalation Engineering Control MOE h Combined Short­ Term Eng. Control Dermal + Eng. Control Inhalation MOE i Combined Interm­ Term Eng. Control Dermal + Eng Control Inhalation MOE i Combined Short­ Term Eng. Control Dermal + Baseline Inhalation MOE i Combined Interm Term Eng. Control Dermal + Baseline Inhalation MOE i Loading/ Applying with a Push Type Spreader ( ORETF) ( 7) Not Feasible Loading/ Applying with a Bellygrinder ( PHED) ( 8) Not Feasible Loading/ Applying Granulars with a Pump Feed Backpack Spreader ( Aldicarb) ( 9a) Not Feasible Loading/ Applying Granular with a Gravity­ Feed Backpack Spreader ( Fipronil) ( 9b) Not Feasible Scoop and Bucket ( Fipronil) ( 10) Not Feasible FLAGGER Flagging Aerial Spray Applications ( 11) tobacco 4 350 0.00022 0.007 110 19 6.4 320 84 18 6.1 4. 8 asparagus ( SLN) , barley 1 350 0. 00022 450 76 26 1300 340 72 24 19 barley 1 1200 0. 00022 130 22 7. 5 380 98 21 7. 1 5. 6 wheat 0. 75 1200 0. 00022 180 29 10 500 130 28 9. 5 7. 5 sorghum 0. 5 1200 0. 00022 270 44 15 750 200 42 14 11 potatoes ( foliar) 0. 5 350 0. 00022 910 150 51 2600 670 140 49 38 cotton ( SLN) 0. 2 350 0. 00022 2300 380 130 6400 1700 360 120 96 Flagging Granular Applications ( 12) tobacco 4 350 0.000056 0.003 450 74 15 750 280 68 15 12 potatoes ( soil) 3 350 0. 000056 600 99 20 1000 370 90 19 17 peas, lentils 2.5 350 0.000056 710 120 24 1200 450 110 23 20 peanuts ( SLN) 2 350 0. 000056 890 150 30 1500 560 140 29 25 clover grown for seed ( SLN) , barley, sorghum, wheat 1 350 0. 000056 1800 300 60 3000 1100 270 58 50 barley, sorghum, wheat 1 1200 0. 000056 520 87 18 880 330 79 17 15 Footnotes: a Application rates are based on maximum values found on various labels or proposed by registrant. In most scenarios, a range of maximum application rates is used to represent the range of rates for different crops/ sites/ uses. Most application rates upon which the analysis is based are presented as lb ai/ A. In the case of ornamentals in pots, the application rate is presented as lb ai/ day) . Specific application rates and the corresponding EPA Reg. numbers that are intended as examples of each exposure assessment scenario are presented in the table indicating risks at baseline attire. 30 Table 4: Occupational Handler Short­ and Intermediate­ Term Exposures and Risks with Engineering Controls continued b Amount handled per day values are based on HED Exposure SAC Policy # 009 Standard Values for Daily Acres Treated in Agriculture, revised June 23, 2000, or best professional judgment when data is not available. c Unless otherwise footnoted, engineering control dermal unit exposure values are from PHED Surrogate Exposure Guide, draft version August, 1998. Engineering control dermal exposure assumes long pants, long sleeved shirt plus closed system mixing/ loading, and enclosed tractor cab/ cockpit. Mixers and loaders wear gloves. ( See Exposure Scenarios Descriptions Table for further information. ) d Unless otherwise footnoted, engineering control inhalation unit exposure values are from PHED Surrogate Exposure Guide, draft version August, 1998. Engineering control inhalation exposure assumes no respirator plus closed system mixing/ loading, and enclosed tractor cab/ cockpit. ( See Exposure Scenarios Descriptions Table for further information. ) e Short­ term dermal MOE = NOAEL ( 0. 5 mg/ kg/ day / short­ term engineering control daily dermal dose ( mg/ kg/ day) , where daily dermal dose = [ unit dermal exposure ( mg/ lb ai) * application rate ( lb ai/ acre) * daily acres treated * dermal absorption ( 100% ) ] / body weight ( 70 kg) . Uncertainty Factor = 100. f Intermediate­ term dermal MOE = NOAEL ( 0. 03 mg/ kg/ day / intermediate­ term engineering control daily dermal dose ( mg/ kg/ day) , where daily dermal dose = [ unit dermal exposure ( mg/ lb ai) * application rate ( lb ai/ acre) * daily acres treated * dermal absorption ( 36% ) ] / body weight ( 70 kg) . Uncertainty Factor = 100. g Baseline inhalation MOE from table indicating risks at baseline attire ( no respirator) h Engineering Control Inhalation MOE = NOAEL ( 0. 045 mg/ kg/ day) / Engineering control inhalation dose, where daily engineering control inhalation dose = ( unit exposure ( F g/ lb ai) * ( 1mg/ 1000 F g) conversion * appl. rate ( lb ai/ A) * acres treated/ day) / body weight ( 70 kg) . Uncertainty Factor = 100. i Total Engineering Control Short­ and Intermediate­ term MOE = 1 1 1 % dermal MOE inhalation MOE 31 Table 5: Exposure Scenario Descriptions for the Occupational Use of Disulfoton continued Table 5: Exposure Scenario Descriptions for the Occupational Use of Disulfoton Exposure Scenario ( Number) Data Source Standard Assumptions a ( 8­ hr work day) Comments b MIXER/ LOADER DESCRIPTORS Mixing/ Loading Liquid Formulations ( Emulsifiable Concentrates) ( 1a, 1b, and 1c) PHED V1.1 1200 and 350 acres for aerial; 350 acres for chemigation; 200 and 80 acres for groundboom application; Baseline: Dermal ( 72 to 122 replicates) ; hand ( 53 replicates) ; and inhalation ( 85 replicates) exposure values are all based on AB grade data. High confidence in the unit exposure value. No protection factors were needed to define the unit exposure value. PPE: The same dermal and inhalation data are used as for the baseline coupled with a 50% protection factor to account for an additional layer of clothing and a 5­ fold protection factor to account for the use of a dust/ mist respirator. Hand ( 59 replicates) exposure value is based on AB grade data. High confidence in the unit dermal exposure value. Engineering Controls: Dermal ( 31 replicates) exposure value is based on AB grade data. Hand ( 31 replicates) and inhalation ( 27 replicates) exposure values are based on AB grade data. High confidence in the dermal unit exposure value. Low confidence in inhalation unit exposure value. Empirical data include the use of chemical­ resistant gloves. No protection factors were needed to define the unit exposure value. Loading Granular Formulations ( 2a and 2b) PHED V1.1 1200 and 350 acres for aerial application, 200 and 80 acres for tractor drawn spreader agricultural application, and 2 acres for ornamental flowers/ groundcover, and trees Baseline: Hands = All grade, dermal = ABC grade, and inhalation = AB grade. Hands = 10 replicates; dermal = 33 to 78 replicates; and inhalation = 58 replicates. Low confidence in dermal/ hand data. High confidence in inhalation data. PPE : Hands = AB grade, dermal = ABC grade. Dermal = 45 replicates, hands = 12­ 59 replicates. Low confidence in dermal and hands data. A 5­ fold PF was applied to the baseline inhalation data to account for the use of a dust mist respirator. Engineering Controls: Closed loading of granulars. 98% PF was applied to baseline data. APPLICATOR DESCRIPTORS Applying Liquid Formulations ( Emulsifiable Concentrates) with an Aircraft ( 3) PHED V1.1 1200 and 350 acres for aerial Baseline: No data PPE: No data Engineering Controls: Hands = AB grade, dermal and inhalation = ABC grade. Medium confidence in hands/ dermal and inhalation data. Hands = 34 replicates, dermal = 24­ 48 replicates, and inhalation = 23 replicates. 32 Table 5: Exposure Scenario Descriptions for the Occupational Use of Disulfoton continued Exposure Scenario ( Number) Data Source Standard Assumptions a ( 8­ hr work day) Comments b Applying Granulars with an Aircraft ( 4) PHED V1.1 1200 and 350 acres for aerial Baseline: No data PPE: No data Engineering Controls: Hands and inhalation ­ All grade, dermal ­ C grade. Hands = 4 replicates, inhalation = 13 replicates, and dermal = 0­ 13 replicates. Low confidence in all data. Applying Sprays with a Groundboom ( 5) PHED V1.1 200 and 80 acres in agricultural applications Baseline: Hand, dermal, and inhalation = AB grades. Hands = 29 replicates, dermal = 23 to 42 replicates, and inhalation = 22 replicates. High confidence in hand, dermal, and inhalation data. PPE: The same dermal and inhalation data are used as for the baseline coupled with a 50% protection factor to account for an additional layer of clothing, and an 80% PF to account for the use of a dust mist respirator, respectively. Hands data are ABC grades with 21 replicates. Medium confidence in hands, and dermal data. Engineering Controls: Hands and dermal = ABC grade, inhalation = AB grade. Hands = 16 replicates, dermal = 20­ 31 replicates, inhalation = 16 replicates. Medium confidence in hands and dermal data, and high confidence in inhalation data. Applying Granulars with a Tractor­ Drawn Spreader ( 6) PHED V1.1 1200 and 80 acres for agricultural crops, 50 acres for Christmas trees; and 40 acres for ornamentals Baseline: Hands, dermal and inhalation = AB grades. Low confidence in hands, dermal and inhalation data. Hands = 5 replicates, dermal = 1­ 5 replicates and inhalation = 5 replicates. PPE: The same hand and dermal data are used as for the baseline coupled with a 90% PF to account for chemical resistant gloves, and a 50% PF to account for an additional layer of clothing, respectively. The same inhalation data are used as for the baseline coupled with an 80% PF to account for the use of a dust mist respirator. Engineering Controls: Hands, dermal and inhalation data are AB grades. Hands = 24 replicates, dermal = 27 to 30 replicates, and inhalation = 2­ 30 replicates. High confidence in hands, dermal and inhalation data. MIXER/ LOADER/ APPLICATOR DESCRIPTORS 33 Table 5: Exposure Scenario Descriptions for the Occupational Use of Disulfoton continued Exposure Scenario ( Number) Data Source Standard Assumptions a ( 8­ hr work day) Comments b Loading and Applying Granulars with a Push Type Spreader ( 7) ORETF Study OMA001 5 acres Baseline : Hand ( 20 replicates) , dermal ( 40 replicates) and inhalation ( 40 replicates) data were used to establish unit exposure values. PPE : The same dermal and inhalation data are used as for the baseline coupled, when needed, with a 50% protection factor to account for an additional layer of clothing and a 80% protection factor to account for the use of a dust/ mist respirator. replicates) data used to establish exposure value. Engineering Controls : Not available for this scenario. Loading/ Applying Granulars Using a Belly Grinder ( 8) PHED V1. 1 1acre Baseline: Hands and dermal = ABC grades and inhalation = AB grade. confidence in hands/ dermal data and high confidence in inhalation data. replicates, dermal = 29­ 45 replicates and inhalation = 40 replicates. PPE: = Gloved data for hands = ABC grade with 15 replicates. al data are taken from the baseline coupled with a 50% protection factor to account for an additional layer of clothing. PF) was applied to baseline inhalation data to account for use of dust mist respirator. Engineering Controls: Not feasible Loading/ Applying Granulars with a Pump­ Feed Backpack Spreader ( 9a) Proprietary ( aldicarb study: MRID # 451672­ 01 5 and 10 acres; 350 pots Baseline: No data PPE: Hand ( with gloves) , dermal, and inhalation = 12 replicates. ed on PHED grading criteria) . A 5­ fold protection factor ( 80% PF) was applied to baseline inhalation data to account for use of dust mist respirator. Engineering Controls: Not applicable. Loading/ Applying Granulars with a Gravity­ Feed Backpack Spreader ( 9b) Proprietary ( fipronil study: MRID # 452507­ 01 5 and 10 acres; 350 pots Baseline: No data PPE: Hand ( with gloves) , dermal, and inhalation = 8 replicates. ed on PHED grading criteria) . A 5­ fold protection factor ( 80% PF) was applied to baseline inhalation data to account for use of dust mist respirator. Gloved­ hand ( 20 Medium Hands = 23 The derm A 5­ fold protection factor ( 80% Grade B data ( bas Grade A data ( bas Engineering Controls: Not applicable. 34 Table 5: Exposure Scenario Descriptions for the Occupational Use of Disulfoton continued Exposure Scenario ( Number) Data Source Standard Assumptions a ( 8­ hr work day) Comments b Loading/ Applying Granulars with a Scoop and Bucket ( 10) Proprietary ( fipronil study: MRID # 452507­ 01 5 and 10 acres; 350 pots Baseline: No data PPE: Hand ( with gloves) , dermal, and inhalation = 10 replicates. Grade A data ( based on PHED grading criteria) . A 5­ fold protection factor ( 80% PF) was applied to baseline inhalation data to account for use of dust mist respirator. Engineering Controls: Not applicable. FLAGGER DESCRIPTORS Flagging Aerial Spray Applications ( 11) PHED V1.1 350 acres Baseline: Hands, dermal and inhalation data = AB grades. High confidence in dermal, hands and inhalation. Hands = 30 replicates, Inhalation = 28 replicates, and dermal = 18­ 28 replicates. PPE: Dermal and hands = AB grade. Hands = 6 replicates, dermal = 18­ 28 replicates. Low confidence for dermal and hands data. A 50% PF was applied to baseline data to represent dust mist masks. Engineering Controls: Hands and dermal = ABC grade, inhalation = AB grade. Inhalation = 16 replicates, dermal = 16 replicates, and dermal = 20­ 31 replicates. Medium confidence in hands, dermal data, and high confidence in inhalation data. These data are based on groundboom enclosed cab data. Flagging Aerial Granular Applications ( 12) PHED V1.1 350 acres Baseline: Hands and dermal = ABC grades. Dermal = 16­ 20 replicates, and hands = 4 replicates. Dermal values based on total deposition data assuming 50% PF applied to no clothes values. Inhalation = E grade with 4 replicates. Low confidence in all values. PPE: Dermal value based on 50% PF over baseline to account for double layer of clothes. Hands values based on 90% PF over baseline to account for use of gloves, and inhalation values based on 50% PF over baseline to account for use of dust mist mask. Engineering Controls: Hands, dermal and inhalation = AB grades with high confidence. Hands = 24 replicates, dermal = 27 to 30 replicates and inhalation = 37 replicates. All data based on granular drop type tractor drawn spreader enclosed cab. Footnotes: a All Standard Assumptions are based on an 8­ hour work day as estimated by HED. b All handler exposure assessments in this document are based on the " Best Available" data as defined by the PHED SOP for meeting Subdivision U Guidelines ( i. e. , completing exposure assessments) . Best available grades are assigned to data as follows: matrices with A and B grade data ( i. e. , Acceptable Grade Data) and a minimum of 15 replicates; if 35 Table 5: Exposure Scenario Descriptions for the Occupational Use of Disulfoton continued not available, then grades A, B and C data and a minimum of 15 replicates; if not available, then all data regardless of the quality ( i. e. , All Grade Data) and number of replicates. High quality data with a protection factor take precedence over low quality data with no protection factor. Generic data confidence categories are assigned as follows: High = grades A and B and 15 or more replicates per body part Medium = grades A, B, and C and 15 or more replicates per body part Low = any run that included D or E grade data or has less than 15 replicates per body part. 36

epa

2024-06-07T20:31:41.604181

regulations

EPA-HQ-OPP-2002-0055-0007

Supporting & Related Material

Disulfoton/ June/ 2001 RED Toxicology Chapter UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF 06/ 25/ 2001 PREVENTION, PESTICIDES AND MEMORANDUM : TOXIC SUBSTANCES Subject: Health Effects Division Toxicity Chapter for Disulfoton for Reregistration Eligibility Decision ( RED) ( Reformatted and Revised) . DP Barcode: D275193 Sub DP Barcode of D239907 Rereg Case: 0102 From: David G Anderson, Toxicologist Reregistration Branch­ 2 HED ( 7509C) To: Christina Jarvis Risk Assessor for Disulfoton RRB­ 2, HED ( 7509C) Thru: Alan Nielsen, Branch Senior Scientist Reregistration Branch­ 2 HED ( 7509C) INTRODUCTION: PC Code: 032501 Cas Reg No. : 274­ 04­ 4 Caswell File No. : 341 Betty Shackleford/ Christina Scheltema Reregistration Branch­ 3 SRRD ( 7507C) This Toxicology Chapter for the Reregistration Eligibility Decision Document represents the second revision to the Toxicology Chapter. The chapter is reformatted according to the SOP as of June 21, 2000. The chapter incorporates two new dermal toxicity studies and a 3 rd HIARC report with revisions to the Occupational/ residential exposure endpoints only. EXECUTIVE SUMMARY: Disulfoton was too toxic for guideline studies on primary eye, skin irritation and dermal sensitization to be conducted, thus the data requirements were waived. Disulfoton is classified as acutely toxic, toxicity category I, by the oral, dermal and inhalation routes of exposure. The mode of action of disulfoton is inhibition of cholinesterase. In all of the studies evaluated in this hazard assessment, the LOAEL and NOAEL were established through the inhibition of cholinesterase ( the basis for all regulatory endpoints) . Clinical signs, such as muscle fasciculation and tremors are seen either at higher dose levels or at the LOAEL for some studies. All three cholinesterases ( plasma, erythrocyte and brain) are inhibited at the lowest dose tested and 1 Disulfoton/ June/ 2001 RED Toxicology Chapter are likely to occur across species including humans. There are slight species differences, but the differences may be due to normal variation and differences in the duration of the studies conducted in different species. Adult females appear to be slightly more sensitive, and in a 6­ month study in rats ( MRID# 43058401) , cholinesterase inhibition was seen only in females. The cholinesterase NOAELs ranged over a 10 fold exposure levels between acute and chronic studies in rats. Longer exposure always show cholinesterase inhibition at lower dose levels. Clinical signs occurred at the same dose level as cholinesterase inhibition in the acute neurotoxicity study, whereas in the 90­ day neurotoxicity study, cholinesterase inhibition occurred at a lower dose level. Motor activity was affected at lower dose levels in the 90­ day study than in the acute study, but no treatment related or significant neuropathology occurred either acutely or in the 90­ day studies. No organophosphate induced neuropathy ( OPIDN) or inhibition of the neurotoxic target enzyme ( NTE) was seen in the acute delayed neurotoxicity study. There is no increased susceptibility to fetuses or pups in acceptable developmental and reproductive toxicity studies in the rabbit or rat. Pup death occurred at the highest dose tested. The deaths were attributed to an inadequate milk supply and maternal care failure. In the developmental toxicity study in the rat, developmental toxicity occurred at higher doses than caused toxicity in dams. Developmental toxicity in the rat was seen in the form of incomplete ossification, but no developmental toxicity was seen in the rabbit at the dose levels administered. In the study on reproduction, cholinesterase was inhibited ( plasma, erythrocyte and brain) in parents at lower dose levels than in pups. No obvious endocrine disruption was seen in any of the studies. Absolute testes and ovarian weights were decreased at the highest dose level, which may be endocrine mediated. These organ weight decreases occurred in the presence of relatively severe cholinesterase inhibition. However, the effect on organ weights could not be unequivocally attributed to endocrine effects. There is an adequate dermal absorption study in rats and adequate 3­ day dermal rat study and 21­ day dermal studies in rabbits showing cholinesterase inhibition ( plasma, erythrocyte and brain) . There are no carcinogenicity concerns in two acceptable studies in the rat and mouse. An adequate dose level was reached in the study in rats to test the carcinogenic potential of disulfoton, based on decreased body weights and body weight gains. In mice, the highest dose tested in this study is approximates 35% of the LD50 and higher dietary concentrations would have resulted in significant compound­ related mortality of the test animals. Thus, the dose levels were considered adequate to test the carcinogen potential of disulfoton in mice. Disulfoton is positive in some mutagenicity studies without activation, but negative or weakly positive in most with activation. With no carcinogenicity concerns and no reproductive toxicity concerns at relevant dose levels, the mutagenicity concerns are low. The mutagenicity data base is complete for the pre­ 1990 required three mutagenicity categories and the in vivo data base support a lack of concern for the mutagenicity of disulfoton. The metabolism of disulfoton was studied in the rat. The toxic metabolites of disulfoton are disulfoton sulfoxide, disulfoton sulfone, disulfoton oxygen analog ( demeton­ S) , disulfoton oxygen analog sulfoxide and disulfoton oxygen analog sulfone. Disulfoton was found to be rapidly absorbed and excreted with over 95% of the administered C 14 labeled disulfoton being recovered in the urine and approximately 90% excretion within 24 hours. Less than 2% was recovered from the feces. Bioaccummulation was not observed with less than 0.3% being recovered in tissues and less than 1% being recovered in the carcass. A major metabolite was incompletely identified, but it co­ 2 Disulfoton/ June/ 2001 RED Toxicology Chapter chromatographed with 1­ ( ethylsulfonyl) ­ 2­ ( methylsulfonyl) ethane, a fully oxidized form of the putative hydrolysis product. The Metabolism Committee determined that the raw agriculture commodity, meat, diary and poultry product residues to be regulated are disulfoton, disulfoton oxygenated analog and their sulfoxides and sulfones. 3 Disulfoton/ June/ 2001 RED Toxicology Chapter DISULFOTON PC Code: 032501 Toxicology Disciplinary Chapter for the Reregistration Eligibility Decision Document Date completed Prepared for: Health Effects Division Office of Pesticide Programs U. S. Environmental Protection Agency Arlington, VA 22202 Prepared by: David G Anderson form: FINAL June 21, 2000 EPA Reviewer: David G Anderson, PhD , Date 1 Disulfoton/ June/ 2001 RED Toxicology Chapter Reregistration Branch­ 2 ( 7509C) Registration Action Branch­ 3 ( 7509C) Secondary EPA Reviewer: Stephen Dapson, PhD , Date TABLE OF CONTENTS 1. 0 HAZARD CHARACTERIZATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 2­ 2. 0 REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 3­ 3. 0 DATA GAP( S) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 4­ 4. 0 HAZARD ASSESSMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 4­ 4. 1 Acute Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 4­ 4. 2 Subchronic Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 5­ 4. 3 Prenatal Developmental Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 8­ 4.4 Reproductive Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 10­ 4. 5 Chronic Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 12­ 4.6 Carcinogenicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 14­ 4.7 Combined Chronic/ Carcinogenicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 15­ 4.8 Mutagenicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 19­ 4. 9 Neurotoxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 20­ 4.10 Metabolism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 23­ 4.11 Special/ other Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 24­ 5.0 TOXICITY ENDPOINT SELECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 27­ 5.1 See Section 8.2 for Endpoint Selection Table. . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 27­ 5. 2 Dermal Absorption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 27­ 5.3 Classification of Carcinogenic Potential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 28­ 6. 0 FQPA Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 28­ 6.1 Special Sensitivity to Infants and Children . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 29­ 6. 2 Recommendation for a Developmental Neurotoxicity Study . . . . . . . . . . . . . . . . ­ 29­ 7. 0 RERERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 29­ 8.0 APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 32­ 8.1 Toxicity Profile Summary Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 33­ 8.1.1 Acute Toxicity Data Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 33­ 8.1.2 Subchronic, Chronic and other Toxicity Tables . . . . . . . . . . . . . . . . . . . . ­ 34­ 8.2 Summary of Toxicological Dose and Endpoints . . . . . . . . . . . . . . . . . . . . . . . . . . ­ 39­ 1.0 HAZARD CHARACTERIZATION Disulfoton was too toxic for guideline studies on primary eye, skin irritation and dermal ­ 2­ Disulfoton/ June/ 2001 RED Toxicology Chapter sensitization to be conducted, thus the data requirements were waived. Disulfoton is classified as acutely toxic, toxicity category I, by the oral, dermal and inhalation routes of exposure. The mode of action of disulfoton is inhibition of cholinesterase. In all of the studies evaluated in this hazard assessment, the LOAEL and NOAEL were established through the inhibition of cholinesterase ( the basis for all regulatory endpoints) . Clinical signs, such as muscle fasciculation and tremors are seen either at higher dose levels or at the LOAEL for some studies. All three cholinesterases ( plasma, erythrocyte and brain) are inhibited at the lowest dose tested and are likely to occur across species including humans. There are slight species differences, but the differences may be due to normal variation and differences in the duration of the studies conducted in different species. Adult females appear to be slightly more sensitive, and in a 6­ month study in rats ( MRID# 43058401) , cholinesterase inhibition was seen only in females. The cholinesterase NOAELs ranged over a 10 fold exposure levels between acute and chronic studies in rats. Longer exposure always show cholinesterase inhibition at lower dose levels. Clinical signs occurred at the same dose level as cholinesterase inhibition in the acute neurotoxicity study, whereas in the 90­ day neurotoxicity study, cholinesterase inhibition occurred at a lower dose level. Motor activity was affected at lower dose levels in the 90­ day study than in the acute study, but no treatment related or significant neuropathology occurred either acutely or in the 90­ day studies. No organophosphate induced neuropathy ( OPIDN) or inhibition of the neurotoxic target enzyme ( NTE) was seen in the acute delayed neurotoxicity study. There is no increased susceptibility to fetuses or pups in acceptable developmental and reproductive toxicity studies in the rabbit or rat. Pup death occurred at the highest dose tested. The deaths were attributed to an inadequate milk supply and maternal care failure. In the developmental toxicity study in the rat, developmental toxicity occurred at higher doses than caused toxicity in dams. Developmental toxicity in the rat was seen in the form of incomplete ossification, but no developmental toxicity was seen in the rabbit at the dose levels administered. In the study on reproduction, cholinesterase was inhibited ( plasma, erythrocyte and brain) in parents at lower dose levels than in pups. No obvious endocrine disruption was seen in any of the studies. Absolute testes and ovarian weights were decreased at the highest dose level, which may be endocrine mediated. These organ weight decreases occurred in the presence of relatively severe cholinesterase inhibition. However, the effect on organ weights could not be unequivocally attributed to endocrine effects. There is an adequate dermal absorption study in rats and adequate 3­ day dermal rat study and 21­ day dermal studies in rabbits showing cholinesterase inhibition ( plasma, erythrocyte and brain) . There are no carcinogenicity concerns in two acceptable studies in the rat and mouse. An adequate dose level was reached in the study in rats to test the carcinogenic potential of disulfoton, based on decreased body weights and body weight gains. In mice, the highest dose tested in this study is approximates 35% of the LD50 and higher dietary concentrations would have resulted in significant compound­ related mortality of the test animals. Thus, the dose levels were considered adequate to test the carcinogen potential of disulfoton in mice. Disulfoton is positive in some mutagenicity studies without activation, but negative or weakly positive in most with activation. With no carcinogenicity concerns and no reproductive toxicity concerns at relevant dose levels, the mutagenicity concerns are low. The mutagenicity data base is complete for the pre­ 1990 required three mutagenicity categories and the in vivo data base support a lack of concern for the mutagenicity of disulfoton. ­ 3­ Disulfoton/ June/ 2001 RED Toxicology Chapter The metabolism of disulfoton was studied in the rat. The toxic metabolites of disulfoton are disulfoton sulfoxide, disulfoton sulfone, disulfoton oxygen analog ( demeton­ S) , disulfoton oxygen analog sulfoxide and disulfoton oxygen analog sulfone. Disulfoton was found to be rapidly absorbed and excreted with over 95% of the administered C 14 labeled disulfoton being recovered in the urine and approximately 90% excretion within 24 hours. Less than 2% was recovered from the feces. Bioaccummulation was not observed with less than 0.3% being recovered in tissues and less than 1% being recovered in the carcass. A major metabolite was incompletely identified, but it co ­ chromatographed with 1­ ( ethylsulfonyl) ­ 2­ ( methylsulfonyl) ethane, a fully oxidized form of the putative hydrolysis product. The Metabolism Committee determined that the raw agriculture commodity, meat, diary and poultry product residues to be regulated are disulfoton, disulfoton oxygenated analog and their sulfoxides and sulfones. 2.0 REQUIREMENTS The requirement ( CFR 158.340) for food and non food use for disulfoton are in Table 1. Use of guideline numbers does not imply that the new ( 1998) guideline protocols were used. Table 1. Test Technical Required Satisfied 870.1100 Acute Oral Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . 870.1200 Acute Dermal Toxicity . . . . . . . . . . . . . . . . . . . . . . . . 870.1300 Acute Inhalation Toxicity . . . . . . . . . . . . . . . . . . . . . . 870.2400 Primary Eye Irritation . . . . . . . . . . . . . . . . . . . . . . . . . 870.2500 Primary Dermal Irritation . . . . . . . . . . . . . . . . . . . . . . 870.2600 Dermal Sensitization . . . . . . . . . . . . . . . . . . . . . . . . . . yes yes yes yes yes yes yes yes yes yes yes yes 870.3100 Oral Subchronic ( rodent) . . . . . . . . . . . . . . . . . . . . . . . 870.3150 Oral Subchronic ( nonrodent) . . . . . . . . . . . . . . . . . . . . 870.3200 21­ Day Dermal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 870.3250 90­ Day Dermal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 870.3465 90­ Day Inhalation . . . . . . . . . . . . . . . . . . . . . . . . . . . . Yes Yes Yes No Yes Yes 1 Yes 2 Yes Yes Yes 870.3700a Developmental Toxicity ( rodent) . . . . . . . . . . . . . . . . 870.3700b Developmental Toxicity ( nonrodent) . . . . . . . . . . . . . 870.3800 Reproduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Yes Yes Yes Yes Yes Yes 870.4100a Chronic Toxicity ( rodent) . . . . . . . . . . . . . . . . . . . . . . 870.4100b Chronic Toxicity ( nonrodent) . . . . . . . . . . . . . . . . . . . 870.4200a Oncogenicity ( rat) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 870.4200b Oncogenicity ( mouse) . . . . . . . . . . . . . . . . . . . . . . . . . 870.4300 Chronic/ Oncogenicity . . . . . . . . . . . . . . . . . . . . . . . . . Yes Yes Yes Yes Yes Yes Yes Yes 870.5100 Mutagenicity Gene Mutation ­ bacterial . . . . . . . . . . 870.5300 Mutagenicity Gene Mutation ­ mammalian . . . . . . . 870.5xxx Mutagenicity Structural Chromosomal Aberrations 870.5xxx Mutagenicity Other Genotoxic Effects . . . . . . . . . . . Yes Yes Yes Yes Yes Yes Yes Yes ­ 4­ Disulfoton/ June/ 2001 RED Toxicology Chapter Test Technical Required Satisfied 870.6100a Acute Delayed Neurotox. ( hen) . . . . . . . . . . . . . . . . . . 870.6100b 90­ Day Neurotoxicity ( hen) . . . . . . . . . . . . . . . . . . . . 870.6200a Acute Neurotox. Screening Battery ( rat) . . . . . . . . . . . 870.6200b 90 Day Neuro. Screening Battery ( rat) . . . . . . . . . . . . 870.6300 Develop. Neuro . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Yes No Yes Yes Yes Yes ­ 3 Yes Yes Pending 4 870.7485 General Metabolism . . . . . . . . . . . . . . . . . . . . . . . . . . 870.7600 Dermal Penetration . . . . . . . . . . . . . . . . . . . . . . . . . . . Yes Yes Yes Yes Special Studies for Ocular Effects Acute Oral ( rat) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Subchronic Oral ( rat) . . . . . . . . . . . . . . . . . . . . . . . . . . Six­ month Oral ( dog) . . . . . . . . . . . . . . . . . . . . . . . . . Reserved Reserved Reserved No No No Special Studies ( NG) Acute and 3­ 5 day Inhalation ( rat) 3­ Day Dermal ( rat) 6­ Month Cholinesterase ( rat) No No Yes Yes 5 Yes 5 Yes 6 1 Requirement is satisfied by Guideline 870.4100a; 2 Requirement is satisfied by Guideline 870.4100b; 3 Not required when the 870.6200a is negative. 4 Currently being conducted in response to the general data­ call­ in for organophosphates. 5 Special studies used in the assessment of occupational/ residential exposure. 6 Requested special study for assessment purposes. 3.0 DATA GAP( S) There are no data gaps, however, disulfoton is subject to a data­ call­ in for organophosphate pesticides ( a confirmatory developmental neurotoxicity study) . 4.0 HAZARD ASSESSMENT 4.1 Acute Toxicity Disulfoton is acutely toxic ( Toxicity category I) with an oral LD50 of 1.9 mg/ kg for female rats. The dermal LD50 is 3.6 mg/ kg for female rats. Note at the LD50, apparently greater than 50% of dermaly applied disulfoton is absorbed, while at lower concentrations only 36% is absorbed. The data requirements for primary eye irritation, dermal irritation and dermal sensitization were waived because of the acute toxicity of disulfoton. The studies on acute neurotoxicity in the hen and rat showed cholinesterase inhibition, but no neuropathy. The acute toxicity data on disulfoton technical are summarized below in Table 2. Table 2. Acute Toxicity Data on disulfoton ­ 5­ Disulfoton/ June/ 2001 RED Toxicology Chapter Guideline No. Study Type MRID # ( S) . Results Toxicity Category 870.1100 Acute Oral 00139595, Doc# 003958, p41 LD50 = M: 6.2 mg/ kg; F: 1.9 mg/ kg I 870.1200 Acute Dermal Acc# 07793, Doc# 03958, p71 & 004223, p24 LD50 = M: 15.9 mg/ kg; F: 3.6 mg/ kg I 870.1300 Acute Inhalation 00147754, Doc# 05789 LC50 = M: 0.06 mg/ L; F: 0.015 mg/ L I 870.2400 Primary Eye Irritation Data requirement waived. Doc# 03958, p12; 004223, p14 Defaults to most severe category 870.2500 Primary Skin Irritation Data requirement waived. Doc# 03958, p12; 004223. p14 Defaults to most severe category 870.2600 Dermal Sensitization Data requirement waived. Doc# 03958, p12 Defaults to most severe category 4.2 Subchronic Toxicity Chronic feeding toxicity studies in the dog, rat and mouse satisfy this requirement for oral subchronic studies. The toxicity data base for subchronic toxicity is considered complete. No additional studies are require at this time. Subchronic inhalation studies in the rat and dermal studies in the rabbit show that cholinesterase is inhibited at the LOAEL. Almost all the studies showed cholinesterase was inhibited in all three compartments. In addition, subchronic oral neurotoxicity studies in the rat ( See Section 4.10) and special 3­ day dermal studies in the rat ( See Section 4.7) show that cholinesterase is inhibited at the LOAEL. 870.3200 21­ Day Dermal Toxicity ­ Rabbits ( 82­ 5) CITATION: Flucke, W. ( 1986) Study of Subacute Dermal Toxicity to Rabbits. Bayer AG, Fachbereich Toxikologie, Wuppertal ­ Elberfeld, F. R. Germany. Study No. : 14747. June 20, 1986. MRID 00162338. Unpublished. EXECUTIVE SUMMARY : In a study ( MRID 00162338) S276 Technical disulfoton ( 97.8% a. i. , Batch No. 79­ R­ 225­ 40) , was applied to the shaved skin of 5 New Zealand White rabbits/ sex/ dose at dose levels of 0, 0.4, 1.6 or 6.5 mg/ kg, 6 hours a day, 5 days/ week for 15 days. Doses were selected based on a preliminary range­ finding study in which clinical signs of cholinergic intoxication and death at 10 mg/ kg/ day following 1 or 2 applications. Slight inhibition of plasma ­ 6­ Disulfoton/ June/ 2001 RED Toxicology Chapter ChE at 2 mg/ kg and no effect on plasma or RBC ChE inhibition at 0.4 mg/ kg. Plasma and RBC ChE were measured at study initiation, day 6, 11, and termination. Brain ChE was determined at termination. Repeated dermal application of disulfoton or vehicle ( Cremophor EL in sterile saline) 6 hours a day for 15 days had no effect on hematology, clinical chemistry, urinalysis, gross pathology and absolute and relative organ weights. There was no dermal reaction to repeated dermal application. Systemic Toxicity was observed in high­ dose males and females as a marked reduction in food consumption and body weights and death ensuing within 1 to 2 weeks of initiation of treatment. The Systemic Toxicity NOAEL = 1.6 mg/ kg/ day and LOAEL = 6.5 mg/ kg/ day , based on reduced food consumption and weight gain. At the highest dose, all males and females died or were sacrificed following . 6 days of treatment due to acute cholinergic signs such as muscle spasms, dyspnea and salivation. In one high dose male which survived 6 treatments, plasma ( 75% ) and RBC ( 31% ) Cholinesterase was depressed. Plasma ChE of mid­ dose males ( 17 ­ 24% ) and females ( 31 ­ 44% ) depressed; RBC ChE of males ( 15 ­ 19% ) and females ( 7 ­ 33% ) was depressed, compared to concurrent controls. Brain ChE of males and females was depressed 7 ­ 8% . The ChE NOAEL = 0.4 mg/ kg/ day and LOAEL = 1.6 mg/ kg/ day , based on inhibition of plasma and RBC ChE and marginal inhibition of brain ChE. The study is classified as Acceptable and satisfies the guideline requirement for a subchronic dermal toxicity study ( 82­ 2) in rabbits. 870.3200 21­ Day Dermal Toxicity ­ Rabbit CITATION: Flucke, W ( 1988) S 276 Technical grade Disulfoton: Study of the Subacute Dermal Toxicity to Rabbits. Bayer AG. , Germany. Study Number 98347. Report No. 116342, January 5, 1988. MRID 45239601. Unpublished. SPONSOR: Bayer Corporation, Stillwell, KS. EXECUTIVE SUMMARY: In a 21­ day dermal toxicity study in rabbits ( MRID 45239601) , disulfoton ( 97% a. i. % ) was administered dermally to New Zealand White ( HC: NZW) rabbits ( 5/ sex/ dose) at dose levels of 0, 0.8, 1.0 or 3.0 mg/ kg/ day for 21­ days. Plasma, erythrocyte cholinesterase was determined day ­ 2, 8, 15 and 21. Brain cholinesterase was determined at termination on day 21. Plasma and erythrocyte cholinesterase were compared with day ­ 2 values while brain cholinesterase was compared with concurrent control values. Clinical observations, chemistry and histological examination of tissues were conducted. Body weight was slightly decreased and statistically significant ( ­ 3% compared with controls) during the last 2 weeks of the study at 3.0 mg/ kg/ day in females. Clinical signs consistent with cholinergic signs occurred in males at the end of the study. Muscle spasm, tremors, diarrhea, and/ or difficulty in breathing in 4 animals and one male death occurred at 3.0 mg/ kg/ day toward the end of the study. One female was lethargic and had difficulty breathing on the last day of the study at 3.0 mg/ kg/ day. No differences attributed to treatment were noted in organ weights or clinical ­ 7­ Disulfoton/ June/ 2001 RED Toxicology Chapter chemistries other than cholinesterase activity. Plasma cholinesterase was statistically significantly inhibited in males at 1.0 and 3.0 mg/ kg/ day at day 15 ( 22% ) and 21 ( 24% ) and at day 8 ( 63% ) , 15 ( 70% ) and 21 ( 65% ) , respectively. In females, plasma cholinesterase was statistically significantly inhibited only at 3.0 mg/ kg/ day and only on day 15 ( 61% ) and 21 ( 61% ) , but it was 44% inhibited on day 8 ( not statistically significant) . Erythrocyte cholinesterase was statistically significantly inhibited in males days 8 ( 53% ) , 15 ( 56% ) and 21 ( 62% ) at 3.0 mg/ kg/ day and day 21 ( 17% ) at 1.0 mg/ kg/ day. In females, erythrocyte cholinesterase was statistically significantly inhibited on days 8 ( 42% ) , 15 ( 55% ) and 21 ( 51% ) at 3.0 mg/ kg/ day, but at 1.0 mg/ kg/ day it was statistically significantly inhibited on days 15 ( 28% ) and 21 ( 25% ) only. Although, erythrocyte cholinesterase was inhibited in females 30% at 1.0 mg/ kg/ day on day 8, it was not statistically significant, possibly due to the high standard deviation in day ­ 2 values used for comparison. However, concurrent control females and the 0.8 mg/ kg/ day dose group showed 21% and 24% erythrocyte cholinesterase inhibition on day 8, respectively, compared with the ­ 2 day values. Thus the 30% erythrocyte cholinesterase inhibition in females on day 8 at 1.0 mg/ kg/ day was not considered biologically significant. At termination, brain cholinesterase was 55% inhibited in males and 27% inhibited in females only at 3.0 mg/ kg/ day ( neither were marked as being statistically significant, but they were depressed according to the report author) . Due to the timing of sample collection in females, depression in brain cholinesterase values seen for females, probably had time to partly reverse before collection. There was no definitive indication from these data that there was or was not accumulation of the test material, which caused increased cholinesterase depression with days on study, however, frequently the day 15 and/ or day 21 values were nominally lower than the day 8 cholinesterase activity values, and cholinergic clinical signs occurred in animals after day 15. The overall NOAEL was 0.8 mg/ kg/ day for any day of dosing. The overall LOAEL is 1.0 mg/ kg/ day based on statistically significant inhibition of plasma cholinesterase in males by day 15 and statistically significant inhibition of erythrocyte cholinesterase inhibition in females by day 15. Significant plasma and erythrocyte cholinesterase inhibition occurred by day 8 only at 3.0 mg/ kg/ day in males and females. This study is classified acceptable and satisfies the Subdivision F guideline requirement for a 21­ day dermal study in rabbits ( 82­ 2) . 870.3465 Subchronic Inhalation/ Rats ( 82­ 4) CITATION: Shiotsuka, RN ( 1989) Subchronic inhalation study of technical grade disulfoton ( Di­ Syston ® ) inhalation in rats. Testing Lab: Mobay Corp. Study# 88­ 141­ AU/ 99648. Date: 7/ 31/ 89. MRID# 41224301. Unpublished study. Executive Summary: Disulfoton was administered by inhalation to 12 Fisher 344 rats per sex per group for air control, polyethylene glycol­ 400: 50% ethanol vehicle control, 0.015, 0.15 or 1.5 mg/ m 3 nominal dose levels for 90­ days in a nose only chamber ( MRID No. : 41224301) . The analytical determined mean dose levels were 0, 0, 0.018, 0.16 and 1.4 mg/ m 3 for male and female rats. The rats were exposed to the test material 6 hours per day, 5 days per week. The particle sizes ­ 8­ Disulfoton/ June/ 2001 RED Toxicology Chapter in the inhalation chambers had a MMAD ± geometric standard deviation of 1.3 ± 1.4, , 1.1 ± 1.3, , 1.0 ± 1.3 and 1.1 ± 1.4 F m for the two controls, 0.015, 0.15 and 1.5 mg/ m 3 nominal dose levels, respectively. The range in mean daily particle sizes had a MMAD of 0.5 ± 1.0 F m to 2.6 ± 1.6 F m. At the highest dose level, plasma cholinesterase was depressed in males ( 19% and 14% from air controls at 38 days and term, respectively, p # 0.05) and in females ( 27% and 31% from air controls at 38 days and term, respectively, p # 0.05) . Brain cholinesterase was depressed in males ( 29% ) and females ( 28% ) at termination. Erythrocyte cholinesterase was depressed in females at 38 days ( 11% at 38 days, p # 0.05, not considered biologically relevant) at 0.16 mg/ m 3 and higher in males and females at 1.4 mg/ m 3 at 38 days and term. Brain cholinesterase were depressed ( 10% , p # 0.05) at 0.16 mg/ m 3 , but this degree of variation was not considered biologically relevant due to variation noted in this parameter. Inflammation of the male nasal turbinates occurred at 1.4 mg/ m 3 . No other test material related effects were noted. The NOAEL/ LOAEL is 0.16 mg/ m 3 / 1.4 mg/ m 3 or 0.00016/ 0.0014 mg/ L for plasma, erythrocyte and brain cholinesterase depression. Core classification: Guideline. The study ( MRID# 41224301) is acceptable under guideline 82­ 4 for a 90­ day inhalation study in rats. Comments about study and/ or endpoint: This study also has cholinesterase inhibition data for day 37. 4.3 Prenatal Developmental Toxicity There is no increased susceptibility to fetuses in acceptable developmental toxicity studies in the rabbit or rat. In the developmental toxicity study in the rat, developmental toxicity occurred at higher doses than caused toxicity in dams. Developmental toxicity in the rat was seen in the form of incomplete ossification, but no developmental toxicity was seen in the rabbit at the dose levels administered. 870.3700 Prenatal Developmental Toxicity Study in Rats ( 83­ 3) CITATION: Lamb­ DW and Hixson­ EJ ( 1983) Embyrotoxic and teratogenic effects of Disulfoton. Study# 81­ 611­ 02 submitted by Mobay Chem. Corp. May 13, 1983. MRID# : 00129458. Unpublished Report. EXECUTIVE SUMMARY: Disulfoton, technical ( 98.2% ) was administered in a carbowax ( polyethylene glycol 400) vehicle by gavage to 25 pregnant Sprague Dawley rats/ group at 0, 0.1, 0.3 or 1.0 mg/ kg/ day from day 6 through day 15 of gestation ( MRID# 00129458) . On day 21, the rats were killed and 50% of each litter was examined for skeletal anomalies and the remainder for visceral anomalies. Cholinesterase inhibition studies on the dams at 21 days ( 2 weeks dosing) indicated an NOAEL/ LOAEL of 0.1/ 0.3 mg/ kg/ day based on 41% inhibition of both plasma and erythrocyte cholinesterase. Fetuses showed incomplete ossification of the intraparietals and sternebrae at 1.0 mg/ kg/ day. The NOAEL/ LOAEL for maternal toxicity were 0.1/ 0.3 mg/ kg/ day based on 41% inhibition of both plasma and erythrocyte cholinesterase. The NOAEL/ LOAEL for ­ 9­ Disulfoton/ June/ 2001 RED Toxicology Chapter developmental toxicity were 0.3/ 1.0 mg/ kg/ day based on incomplete ossification of the intraparietals and sternebrae. The study is acceptable under Guideline 83­ 3 for a developmental toxicity study in rats. ­ 10­ Disulfoton/ June/ 2001 RED Toxicology Chapter 870.3700 Prenatal Developmental Toxicity in Rabbits ( 83­ 3) CITATION: Tesh­ JM et al. ( 1982) S276: Effects of oral administration upon pregnancy in the rabbit. An unpublished report ( Bayer No. R 2351) prepared by Life Science Research, Essex, England and submitted to Bayer AG, Wuppertal, Germany. Dated December 22, 1982. MRID# 00147886. Unpublished Report. EXECUTIVE SUMMARY: Disulfoton, technical was administered by gavage in a corn oil vehicle ( 5ml/ kg) to 15, 14, 14 or 22 pregnant New Zealand White rabbits per group at 0, 0.3, 1.0 or 3.0 mg/ kg/ day, respectively from day 6 to 18 of gestation ( MRID# 00147886) . Since mortality and clinical signs were observed at 3.0 mg/ kg/ day, this dose level was reduced to 2.0 mg/ kg/ day and finally to 1.5 mg/ kg/ day. Analysis showed that the dosing solutions were 17, 14 and 10% below the target concentrations for the low to highest doe tested ( HDT) , respectively. Females were artificially inseminated. Maternal signs such as muscle tremors, unsteadiness/ in coordination and increased respiratory rate were seen 4 hours after dosing and in some cases persisted for more than 24 hours at the HDT. No toxic signs were noted at the MDT and LDT. At the MDT one low and 3 control females were found dead or moribund from a mid­ ear disease or respiratory infection. Test material related mortalities at the HDT occurred mostly prior to dosage reduction to 1.5 mg/ kg. Nine of 22 animals survived to termination at the HDT. Two animals aborted at the MDT. No test material related body weight changes were noted. No dose related soft tissue or skeletal anomalies were noted at any dose levels. The NOAEL/ LOAEL for dams were 1.0/ 1.5 based on tremors, unsteadiness/ in coordination and increased respiration. The NOAEL/ LOAEL for developmental toxicity were > 3.0/ > 3.0 mg/ kg/ day. The study is acceptable for Guideline 83­ 3 for a developmental toxicity study in rabbits and was upgraded from supplementary to fully acceptable in HED Doc# 004698 and by the RfD/ QA Peer Review Committee. 4.4 Reproductive Toxicity There is no increased susceptibility to pups in two acceptable reproductive toxicity studies in the rat. Pup death occurred in the newer study at the highest dose tested. The deaths were attributed to an inadequate milk supply and maternal care failure. In the newer study on reproduction, cholinesterase was inhibited ( plasma, erythrocyte and brain) in parents at lower dose levels than in pups. The newer study measured more endpoints than the older study, but the results of the two studies were not inconsistent. 870.3800 Two­ Generation Reproductive Toxicity Study/ Rats ( 83­ 4) CITATION: Astroff, A Barry ( 1997) A Two Generation Reproductive Toxicity study with Disulfoton Technical ( Disyston ® ) in the Sprague Dawley Rat. Laboratory name Bayer Corp. , ­ 11­ Disulfoton/ June/ 2001 RED Toxicology Chapter Stilwell, KA. Laboratory report number: 95­ 672­ FZ, report# 108002, File 8368. November 19, 1997. MRID# 44440801. Unpublished EXECUTIVE SUMMARY: In a 2­ generation reproduction study ( MRID# 44440801) disulfoton, technical, 99% a. i. ] was administered to 30 Sprague Dawley rats/ / sex/ dose in the diet at dose levels of 0, 0.5, 2.0 or 9.0 ppm ( 0, 0.025, 0.10 or 0.45 mg/ kg/ day by std. tables) . Dosing was continuous for the P0 and F1 generation. Only one littering/ animal/ group was conducted. In this second 2­ generation reproductive toxicity study with disulfoton, cholinesterase activity was measured in adults during pre­ mating ( at 8 weeks) and at termination and in pups at postnatal day 4 and day 21 in the 2 generations. The major effects noted were cholinesterase inhibition and dams with no milk. In P0 males, plasma cholinesterase ( PCHE) was significantly depressed and dose related pre­ mating at 9.0 ppm ( $ ­ 34% ) and at termination at 2.0 ( $ ­ 11% ) and 9.0 ppm ( ­ 46% ) . In P0 females, plasma cholinesterase ( PCHE) was significantly depressed pre­ mating ( $ ­ 29% ) and at termination ( $ ­ 52% ) at $ 2.0 ppm. In P0 males and females erythrocyte cholinesterase ( ECHE) was significantly depressed and dose related at $ 2.0 ppm ( $ ­ 38% & $ ­ 35% males and $ ­ 46% & $ ­ 80% females) a pre­ mating and termination, respectively, but only in females at termination ( $ ­ 14% ) at $ 0.5 ppm. In P0 males and females brain cholinesterase ( BCHE) was significantly depressed and dose related at $ 2.0 ppm in males ( $ ­ 11% ) and $ ­ 14% in females at $ 0.5 ppm. . PCHE and ECHE depression in F1 males and females followed a similar nominal pattern to that in P0 males and females, except that the statistical significance varied within the F1 between two dose levels; sometimes the dose level showing statistical significance was higher and sometime lower of the two. In F1 males and females, BCHE was significantly depressed and dose related at $ 2.0 ppm in males ( $ ­ 14% ) and in females ( $ ­ 50% ) . In F1 and F2 male and female pups at day 4 and/ or day 21 of lactation, PCHE and ECHE were significantly depressed at 9.0 ppm. Values for PCHE and ECHE, respectively were at day 4 or day 21 in F1 male pups were ( ­ 24% & ­ 47% ) and for F1 female pups ( ­ 31% & ­ 43% ) . Values for PCHE and ECHE, respectively, were at day 4 or day 21 in F2 male pups were ( ­ 46% & ­ 53% ) and for F2 female pups ( ­ 48% & ­ 51% ) . In F1 and F2 male and female pups BCHE was significantly depressed at day 4 and day 21 at 9.0 ppm only ( day 4 = ­ 14% F1 males and ­ 17% F1 females) ( day 21 = ­ 19% F1 males and ­ 23% F1 females) ( day 4 = ­ 11% F2 males and ­ 13% F2 females) ( day 21 = ­ 35% F2 males and ­ 37% F2 females) . Muscle fasciculation ( 1 P0 female) , tremors ( 15 P0 females, 10 F1 females) and dams ( 7 F1 dams) with no milk were noted at 9.0 ppm. No treatment related organ weight changes or histopathology were noted in P0 or F1 males or females at any dose level. Clinical observations indicate that dams were not caring for their pups. Observed affects in pups in the 9.0 ppm group included 12 F1 ( 2 dams) pups cold to the touch and 3 F1 ( 2 dams) not being cared for and 63 F2 pups ( 7 dams) with no milk in their stomachs and 93 F2 weak pups ( 10 dams) from the affected dams. In addition, 1 P0 dam was salivating and gasping and did care for the litter and the litter died at 2.0 ppm. This effect at 2.0 ppm was considered test material related by the summary author of the 6( a) ( 2) submission ( See summary 6( a) ( 2) report, MRID# 44440801; memorandum from David Anderson to PM 53, dated March 24, 1998, D242573) , but ignored in the final report summary. Findings at necropsy were noted in F2 pups at 9.0 ppm that were expected in view of the maternal toxicity at this dose level. The report reasonably considered the pup deaths due to failure of maternal care, because of the weak and cold to the touch pups and failure of the pups to show milk in their stomachs. On careful examination of the report, this reviewer agrees ­ 12­ Disulfoton/ June/ 2001 RED Toxicology Chapter with this conclusion. Thus, under these conditions, the effects in pups were caused by maternal toxicity and not the direct toxicity of disulfoton on pups. Body weight change was lower than control values during gestation in P0 ( ­ 9% ) and F1 ( ­ 15% ) females. Body weights were significantly reduced at termination from control values in P0 ( ­ 6% ) and F1 females ( ­ 13% ) and in F1 males ( ­ 8% ) . No other significant body weights or changes were noted. The P0 parental LOAELs were 0.5 ppm ( 0.025 mg/ kg/ day) based on brain cholinesterase activity depression in P0 females with tremors and muscle fasciculation at 9 ppm in females during gestation and lactation from both generations and with body weight decrements at 9.0 ppm, especially at termination. A NOAEL of 0.5 ppm ( 0.025 mg/ kg/ day) was seen in F1 parents. F1 and F2 pup ( 4 day and 21 day old) cholinesterase activity, including brain cholinesterase activity was depressed only at 9.0 ppm ( 0.45 mg/ kg/ day) with 2.0 ppm ( 0.10 mg/ kg/ day) being the NOAEL. The F1 pup NOAEL/ LOAEL were 2.0/ 9.0 ppm ( 0.10/ 0.45 mg/ kg/ day) based on treatment related pup deaths and pup weight decrements at 9.0 ppm, probably from inadequate maternal care. The reproductive study in the rat is classified acceptable and does satisfy the guideline requirement for a 2­ generation reproductive study ( OPPTS 870.3800, § 83­ 4) in rat. 870.3800 Two­ Generation Reproductive Toxicity/ Rats ( 83­ 4) CITATION: Hixson, EJ and Hathaway, TR ( 1986) Effect of disulfoton ( Di­ Syston ® ) on reproduction in the rat. Conducting laboratory: Mobay Chem. Date: 2/ 12/ 86. Study# 82­ 671­ 02. MRID# 00157511. Unpublished Study. EXECUTIVE SUMMARY: In an acceptable 2­ generation reproductive toxicity study ( MRID# 00157511; HED Doc# 011959 & 005796) , disulfoton, technical ( 97.8% ) was administered at 0, 1, 3 or 9.0 ppm ( 0, 0.04, 0.12 or 0.36 mg/ kg/ day) . In this first and older reproduction study cholinesterase activity was measured in pups, but not in adults. In this first study of reproductive toxicity, the parental toxicity NOAEL/ LOAEL were 3/ 9 ppm or 0.12/ 0.36 mg/ kg/ day based on nominally reduced incidence of females with sperm and reduced body weight in gestating and lactating P0 females with cholinesterase being probably inhibited with a NOAEL/ LOAEL of 1/ 3 ppm or 0.04/ 0.12 mg/ kg/ day. These latter cholinesterase results were supported by results from the chronic/ oncogenicity rat study. Toxicity on reproduction showed a NOAEL/ LOAEL of 1/ 3 ppm or 0.04/ 0.12 mg/ kg/ day based on F1a weanling pup brain cholinesterase inhibition and F2b pup survival. The study is acceptable for a guideline ( 83­ 4) study on reproduction in the rat. 4.5 Chronic Toxicity Two chronic feeding studies were conducted in dogs, both showing cholinesterase inhibition at the LOAEL. The newer study in dogs included cholinesterase inhibition in eye tissue and studied more parameters and showed a slightly lower NOAEL than the older study, but the studies were ­ 13­ Disulfoton/ June/ 2001 RED Toxicology Chapter consistent with the each other. The newer study was used for risk assessment. The chronic feeding toxicity study in the rodent is satisfied by the combinded chronic/ carcinogenicity study in rats ( See Section 4.7) . 870.4100b Chronic Toxicity ­ Dogs ( 83­ 1b) CITATION: Jones, R. D. and T. F. Hastings ( 1997) Technical grade Disulfoton: A chronic toxicity feeding study in the Beagle dog. Bayer Corporation, Stillwell, KS. Study Number 94­ 276­ XZ. Report No. 107499. February 5, 1997. MRID 44248002. Unpublished. EXECUTIVE SUMMARY: In a chronic toxicity study ( MRID 44248002) , disulfoton ( 97% a. i. % ) was administered orally in the diet to purebred beagle dogs ( 4/ sex/ dose) at dose levels of 0.5, 4 or 12 ppm ( equivalent to 0.015, 0.121 and 0.321 mg/ kg/ day for males; and 0.013, 0.094 and 0.283 mg/ kg/ day for females) for one year. Potential ocular and neurologic effects were addressed. Plasma cholinesterase was decreased starting at day 7 in the 4.0 ppm dose groups of the study through to termination ( males 39% to 46% ; females 32% to 45% ) . Erythrocyte cholinesterase was decreased starting at day 91 in the 4.0 ppm dose groups through to termination ( males 23% to 48% ; females 17% to 49% ) . Not all the values at 4.0 ppm were statistically significant, probably because of the wide range in values, but at least 2 animals per group showed biologically significant cholinesterase inhibition. By termination cholinergic effects of the plasma, erythrocytes, brain, and ocular tissues were observed in both sexes in the 4 and 12 ppm treatment groups. Plasma and erythrocyte cholinesterase depression are compared to pretreatment values. Brain, cornea, retina and ciliary body cholinesterase depression are compared with concurrent control values at termination only. In the 12 ppm treatment groups, depressed cholinesterase was observed in plasma ( 56% ­ 63% ) , erythrocytes ( 30% ­ 91% ) , and brain ( 32% ­ 33% ) compared to their respective controls. In the 4 ppm treatment groups in males and females, cholinesterase was depressed in plasma ( 38% ­ 46% ) , erythrocytes ( 40% ­ 38% ) , and brain ( females only, 22% ) . Disulfoton inhibited cholinesterase of the cornea, retina, and ciliary body, but did not appear to alter the physiologic function of the visual system. In the 12 ppm treatment groups, depressed cholinesterase was observed in the cornea ( 60­ 67% ) , ciliary body ( 45­ 54% ) , and retina ( males only; 67% ) . In the 4 ppm treatment groups, cholinesterase was inhibited in the cornea ( 50­ 60% lower) , and retina ( females only, 25% ) . No treatment­ related ophthalmology findings or histological or electrophysiological changes in the retina were observed. No other treatment­ related effects were observed. No animals died during the study. No treatment­ related effects were observed in systemic toxicity including food consumption, body weights, clinical signs, hematology, clinical blood chemistry or urinalysis parameters, electroretinograms, electrocardiogram or clinical neurological findings, organ weights or gross or microscopic post­ mortem changes in any treatment group. No neoplastic tissue was observed in dogs in the treatment and control groups. The LOAEL is 4 ppm ( 0.094 mg/ kg/ day) , based on depressed plasma, erythrocyte, and corneal cholinesterase levels in both sexes, and depressed brain and retinal cholinesterase levels in females. The NOAEL is 0.5 ppm ( 0.013 mg/ kg/ day) . These LOAEL/ NOAEL for plasma cholinesterase inhibition extend from day 7 to termination and for erythrocyte cholinesterase inhibition they extend from day 91 to ­ 14­ Disulfoton/ June/ 2001 RED Toxicology Chapter termination. This study is classified acceptable and satisfies the Subdivision F guideline requirement for a chronic oral study in non­ rodents ( 83­ 1b) . 870.4100b Chronic Toxicity ­ Dogs ( 83­ 1b) CITATION: Hoffman, K. ; Weischer, C. H. ; Luchaus, G. ; et al. ( 1975) S 276 ( Disulfoton) Chronic Toxicity Study in Dogs ( Two­ year Feeding Experiment) . Bayer, AG, W. Germany. Report No. 45287. December 15, 1976. MRID 00073348. Unpublished. EXECUTIVE SUMMARY: In a chronic feeding study ( MRID 00073348) Technical Di­ Syston ( 95.7% a. i. ) was administered in diet to 4 Beagles/ sex/ dose in the diet at dose levels of 0, 0.5, 1 or 2/ 5/ 8 ppm ( 0, 0.0125, 0.025 or 0.05/ 0.125/ 0.2 mg/ kg/ day, converted) for 104 weeks. In the high­ dose group, 2 ppm was given for first 69 weeks, 5 ppm from 70 ­ 72 weeks, and 8 ppm from week 73 ­ termination. Body weights were determined weekly for 52 weeks, then biweekly until termination. Clinical evaluations to detect cholinergic signs, ophthalmological evaluations, hematology, clinical chemistries, urinalysis were performed on all animals pre­ treatment, on weeks 13, 26, 39, 52, 65, 78, 91, and at termination. Plasma, and RBC cholinesterase was determined at 2­ week intervals during the first 13 weeks and at about 3 month intervals thereafter. Brain cholinesterase was determined immediately after necropsy. Treatment had no effects on general appearance and behavior, and toxic signs, ophthalmoscopy examinations, food consumption, body weight, hematology, clinical chemistry, organ weight and/ or histopathology. At 2 ppm, plasma and RBC cholinesterase ( ChE) was inhibited 50 and 33% in males and 22 and 36% in females, respectively, during week 40. Large fluctuations in plasma and RBC ChE inhibitions occurred until the dose was raised to 8 ppm. By the termination ( 104 weeks) of study, the plasma, RBC and brain ChE was inhibited 65, 58, and 34% in males and 49, 48 and 18% in females, respectively, compared to pre­ treatment values. Based on the above, the Systemic Toxicity NOAEL = 2 ppm ( 0.05 mg/ kg/ day) and LOAEL > 2 ppm . The cholinesterase NOAEL = 1 ppm ( 0.025 mg/ kg/ day) and LOAEL = 2 ppm ( 0.05 mg/ kg/ day) , based on plasma and RBC ChE inhibition. The study is classified as Acceptable and satisfies the guideline requirement for a chronic toxicity study ( 83­ 1b) in the dog. 4.6 Carcinogenicity The two carcinogenicity studies in mice and rats were adequately conducted and showed no treatment related carcinogenicity. The study in mice showed only cholinesterase inhibition, but the rat study showed body weight decrement, Harderian gland degeneration, and lesions of the eye and optical nerve, all at higher dose levels than the cholinesterase inhibition. 870.4200b Carcinogenicity/ Mice ( 83­ 2b) ­ 15­ Disulfoton/ June/ 2001 RED Toxicology Chapter CITATION: Hayes, R. H ( 1983) Oncogenicity study of disulfoton technical on mice. Corporate Toxicology Department, Mobay Chemical Corporation, Stilwell, KS. Study No. 80­ 271­ 04. August 10, 1983. MRID 00129456. Unpublished study. EXECUTIVE SUMMARY: In a carcinogenicity toxicity study ( MRID 00129456 & 00139598) , disulfoton ( 98.2% a. i. ) was administered to 50 Crl: CD­ 1 mice/ sex/ dose in the diet at dose levels of 0, 1, 4, or 16 ppm ( 0.15, 0.6, or 2.4 mg/ kg/ day, converted) for 108 weeks. In addition, 10 mice/ sex/ group were used as replacement animals. Cholinesterase activity in the plasma, RBC, and brain was determined at final sacrifice for 10 mice/ sex randomly selected from the control and 16 ppm groups. Treatment had no effect on bodyweights, food consumption, hematology, and mortality. Eight mice i. e. , 1 male and 3 females from the 1 ppm group, 3 males from the 4 ppm group, and one male from the 16 ppm group, died during the first month and were replaced. Survival at 18 months ranged from 76 ­ 86% in all males, and 68 ­ 82% in all females. At termination survival ranged from 56 ­ 66% and 38 ­ 54% , in males and females, respectively. Cholinesterase ( ChE) was markedly inhibited at the high­ dose. In males, the plasma, RBC and brain ChE was inhibited 79, 56, and 44% ; and in females it was inhibited 82, 50, and 46% , respectively, compared to controls. Enlarged spleen, liver, and lymph nodes were observed with greater frequency in females than males, ; histologically diagnosed as lymphomas. The number of animals with malignant lymphoma, of all histologic cell types, were 10, 9, 12, and 15 in males and 27, 22, 26, and 34 in females, at 0, 1, 4, and 16 ppm, respectively. Tumor incidence lacked statistical significance by either the Chi­ square or Fisher exact test. In high­ dose females, absolute and relative kidney weights increased 22% and 11% , respectively, probably related to increased incidence of lymphomas in this organ. None of the increased organ weights/ histopathological findings were considered treatment­ related. Based the above findings, the Systemic Toxicity LOAEL > 2.4 mg/ kg/ day and LOAEL = 2.4 mg/ kg/ day , based on plasma, RBC and brain ChE inhibition in males and females. The NOAEL = 0.6 mg/ kg/ day . At the doses tested, there was not a treatment related increase in tumor incidence when compared to controls. Dosing was considered adequate for testing the carcinogenic potential of disulfoton, even though, there was no clear indications of systemic toxicity such as body weight gains and liver specific enzymes. The highest dose tested in this study is approximates 35% of the LD50 and higher dietary concentrations would have resulted in significant compound­ related mortality of the test animals. The study is classified as Acceptable , and satisfies the guideline requirement for a oncogenicity study ( 83­ 2b) in mice. 4.7 Combined Chronic/ Carcinogenicity 870.4300 Combined Chronic/ Carcinogenicity ­ Rats CITATION : Hayes, R. H ( 1985) Chronic feeding/ oncogenicity study of technical disulfoton ( Di­ SYSTON) with rats. Mobay Chemical Corporation, Stilwell, KS. Study No. 82­ 271­ 01. June 25, 1985. MRID # s 00146873. Unpublished. and ­ 16­ Disulfoton/ June/ 2001 RED Toxicology Chapter Supplementary data upgrading MRID# 00146873 from supplementary to acceptable on the Harderian gland ( MRID# 41850001) and optical and optic nerve lesions ( MRID# 41850002) . EXECUTIVE SUMMARY: In a chronic feeding/ carcinogenicity study ( MRID # 00146873, 41850001, 41850002) Disulfoton ( 98.1% a. i. , Batch No. 79­ R­ 255­ 40) was administered to 60 Fischer 344 rats/ sex/ dose in the diet at dose levels of 0, 0.8, 3.3, or 13 ppm ( 0, 0.04, 0.165, or 0.650 mg/ kg/ day, converted by std. tables) for 105 weeks. Hematological determinations were done on 20/ sex/ dose and urine and blood chemistry on 10/ sex/ dose, randomly selected, at 0, 3, 6, 12, 18, and 24 months. Plasma and red cell cholinesterase ( ChE) was determined on 10 rats/ sex/ dose at pre­ treatment, 4, 14, 27, 53, 79 and 105 weeks and brain ChE at termination. Administration of disulfoton in the diet up to 13 ppm had no effect on mortality, hematology, clinical chemistry and urine analysis. Mean body weights of high­ dose rats were significantly depressed throughout the study. Body weight gains of high­ dose males and females were depressed 29% and 48% , respectively, by termination when compared to the controls. At the mid and low dose, mean body weights of males were sporadically depressed, however, by the end of study the mean body weights were similar to controls. Females body weights were not effected at these dose levels. At 13 ppm, in females the absolute heart ( 9% ) , liver ( 17% ) , and testes ( 24% ) were decreased; in females the heart ( 13% ) , kidneys ( 13% ) , liver ( 27% ) and ovaries ( 57% ) decreased. Absolute brain weight was unchanged in males and females. In high­ dose females the relative brain ( 59% ) , heart ( 33% ) , and kidneys ( 34% ) increased, compared to the controls. Also, the relative lung ( 72% ) and liver ( 9% ) and brain ( 58% ) weights were increased. At this dose the male relative brain weights were increased by 17% . None of the aforementioned organ weights were associated with any histopathology corroborative of toxicity. In high­ dose males Harderian gland degenerative changes increased to 460% of controls and in females the elevation was dose­ related ( 800, 1100 and 1633% of control values, respectively, all p # 0.05) . Since there is no Harderian gland in the humans, the significance of pathological changes seen in the rat are uncertain. In addition, corneal vascularity ( 693% of control) , corneal epithelial hyperplasia ( 1633% of control) and optic nerve degeneration ( 145% of control) were elevated in high­ dose females and corneal vascularity ( 329% of control) in males. The eye histopathology was not affected in the mid and low doses. Based on the above, the Systemic Toxicity NOAEL = 0.8 ppm ( 0.04 mg/ kg/ day) and LOAEL = 3.3 ppm ( 0.165 mg/ kg/ day) , based on Harderian gland degeneration. At termination, a dose­ related inhibition in plasma, red cell and brain ChE was observed at all doses in both sexes. In males the plasma, red cell and brain ChE was inhibited 11% ­ 94% , 19% ­ 80% , and 16% ­ 79% ; and in females, it was 25% ­ 95% , 12% ­ 76% , and 21% ­ 82% , respectively, compared to the controls. The Cholinesterase NOAEL < 0.8 ppm ( 0.04 mg/ kg/ day) and LOAEL = 0.8 ppm ( 0.04 mg/ kg/ day) , based on plasma, red cell and brain ChE inhibition in males and females. Starting at week 4 the LOAEL in plasma ChE inhibition was 4 ppm ( 0.165 mg/ kg/ day) in males ( 27% ) and females ( 64% ) with a NOAEL of 1 ppm ( 0.04 mg/ kg/ day) . Starting at week 4 the LOAEL in erythrocyte ChE inhibition was increased at 1 ppm ( 0.04 mg/ kg/ day) ( LDT) in males ( 16% ) and females ( 30% ) with no NOAEL. The maximum tolerated dose ( MTD) was reached, based on decreased body weights and body weight gains and is considered adequate to test the carcinogenic potential of Disulfoton. Disulfoton treatment did not alter the spontaneous oncogenicity profile in both males and female Fischer 344 rats under the test conditions. In males and females, leukemia, adrenal cortex adenoma, adrenal pheochromocytoma, pituitary adenoma and carcinoma and thyroid­ C cell adenoma was ­ 17­ Disulfoton/ June/ 2001 RED Toxicology Chapter most frequently observed. Mammary gland fibroadenoma in both sexes, but most frequently in females. Testicular interstitial adenoma in males and stromal polyp of the uterus in females was observed. All these neoplasms were similar in type, time of onset, and incidence in both controls and disulfoton treated animals. The study is classified as Acceptable and satisfies the guideline requirement for a chronic feeding/ carcinogenicity study ( 83­ 5) in the rat. 870.4300 Chronic Feeding/ Oncogenicity Study/ Rats ( 83­ 5) CITATION: Carpy, S. ; Klotzsche, C. ; Cerioli, A. ( 1975) Disulfoton: 2­ Year Feeding Study in Rats. Sandoz, Ltd. , Switzerland. Report No. 47069. December 15, 1976. MRID 00069966. Unpublished. EXECUTIVE SUMMARY: In a chronic feeding/ carcinogenicity study ( MRID 00069966) Technical Di­ Syston ® ( ( 95.7% a. i. ) was administered to 60 SPF Sprague­ Dawley rats/ sex/ dose in the diet at dose levels of 0, 0.5/ 5.0, 1.0 or 2.0 ppm ( 0, 0.0215/ 0.1900, 0.0456, or 0.0893 mg/ kg/ day in males and 0, 0.0267/ 0.1960, 0.0419 or 0.1033, mg/ kg/ day in females, respectively; calculated) for 104 weeks. The 0.5 ppm dose was fed for 81 weeks, then increased to 2 ppm because of no effects seen at the 1 ppm dose level. The rats in the 2 ppm group were initially maintained at 1.5 ppm for 4 ­ 5 weeks, then increased to full dose. Body weight, food consumption, food efficiency, hematology, clinical chemistries, and urinalysis were determined. Plasma, red cell and brain cholinesterase was determined from 5 overnight fasted animals/ sex/ group at termination. Necropsy was done on 10 animals/ sex/ dose; all others were examined for tumors. Histopathology was done on 5 animals/ sex from the control and the 5 ppm group. Treatment with Di­ Syston did not effect, food consumption, body weight gain, hematology, clinical chemistry, and urinalysis. Mortality was high ( 20 ­ 37% ) in females but lacked the dose response and no clear explanation was offered for cause of death; more than 1/ 3 of the dead animals autolyzed. At 0.5/ 5 ppm, in males the absolute/ relative liver, spleen and kidney weights increased 12% / 8% , 21% / 17% and 23% / 19% , respectively ( P # 0.05) ; however, the histopathology of the organs were unremarkable. There was a trend for decreased absolute and relative brain weights in males and increased trend in females. The Systemic Toxicity LOAEL > 1 ppm . Cholinesterase levels in plasma, red cells and brain was inhibited in males and females at two higher doses and it was dose­ related. At 2 ppm, the plasma, red cell and brain ChE of males was inhibited 14, 9.3, 9% , and in females 22, 13.3 and 17% , respectively, compared to the controls. At the 0.5/ 5 ppm dose, plasma, red cell and brain ChE of males and females was inhibited 20 ­ 39.6, 18.3 ­ 27.1 and 25 ­ 36% , respectively. ChE levels in the 1 ppm group males and females was not effects. The ChE NOAEL = 1 ppm and the LOAEL = 2 ppm , based on decreased plasma, red cell and brain cholinesterase levels. The study is classified as Unacceptable and can not upgraded because multiple deficiencies in the conduct of the study and does not satisfy the guideline requirement for chronic toxicity/ oncogenicity study ( 83­ 5) in the rat. ­ 18­ Disulfoton/ June/ 2001 RED Toxicology Chapter 4.8 Mutagenicity The following was taken from a document written by Nancy McCarroll for the Hazard Identification Assessment Review Committee proceedings. Combining the acceptable studies with the additional EPA­ sponsored studies will satisfy the Pre­ 1991 mutagenicity initial testing battery guidelines. No further mutagenicity testing has been identified at this time. In addition, disulfoton is not genotoxic in vivo or carcinogenic in mice or rats. In some of the mutagenicity studies, positive effects were seen without activation while negative effects were seen with activation. This may be due to microsomal enzyme metabolism, since pretreatment of rats and mice with phenobarbital reduces toxicity from disulfoton. Gene Mutation ( 84­ 2) Salmonella typhimurium/ Escherichia coli reverse gene mutation plate incorporation assay ( Accession No. 00028625; Doc. No. 003958: As part of an Agency sponsored mutagenicity screening battery, disulfoton was negative in all strains up to the HTD ( 5000 F g/ plate + / ­ S9) in three independent trials. Chinese hamster ovary ( CHO) cell HGPRT forward gene mutation assay ( MRID# 40638401, Doc# 008394) : This unacceptable study is considered to be positive, because the assay was conducted at partially soluble levels( 0.1­ 1.0 F L/ ml ­ S9; 0.7­ 1.0 F L/ ml + S9) and insoluble doses ( 5­ 10 F L/ ml ­ S9; 3­ 10 F L/ ml + S9) but not active at soluble concentrations ( # 0.06 F L/ ml + / ­ S9) . The mutagenic response appeared to be stronger without metabolic ( S9) activation . Chromosome Aberrations ( 84­ 2) Mouse micronucleus test ( MRID No. 43615701) No increase over background in micronucleated polychromatic erythrocytes ( evidence of cytogenetic damage) of mice treated intra­ peritoneally up to MTD levels ( 8 mg/ kg) . Lethality and other signs of toxicity, but no bone marrow cytotoxicity was seen. Other Gene Mutations: ( 84­ 2) Bacterial DNA Damage/ Repair: E. Coli DNA damage/ repair test ( Accession# 072293; Doc# 004698) : The test is negative up to the HDT ( 10,000 F g/ plate + / ­ S9. Mitotic Recombination: Saccharomyces cerevisiae D3 mitotic recombination assay ( Accession# 00028625; Doc# 003958) : Disulfoton ( up to 5% + / ­ S9) was negative at this endpoint in the Agency­ sponsored mutagenicity screening battery. The study is currently listed as unacceptable, but should be upgraded to acceptable. Upon further review of the data, it was decided that the reason for rejecting the study ( number of replicates/ dose not provided) did not interfere with the interpretation of the findings. Sister Chromatid Exchange: Sister chromatid exchange in CHO cells ( MRID# 40945001; Doc# ­ 19­ Disulfoton/ June/ 2001 RED Toxicology Chapter 008394) : Positive, dose related effects at 0.013­ 0.1 F L/ ml without S9, but not active in the S9 activated phase of testing up to a level ( 0.20 F L/ ml) causing cell cycle delay. Sister Chromatid Exchange: Sister chromatid exchange in Chinese hamster V79 cells ( Accession# 072293; Doc# 0044223) : The test is negative without activation up to the HTD ( 80 F g/ ml) . Subsequently tested by the same investigators ( Chen et al. , 1982; Environ. Mutagen. 4: 621­ 624) in the presence of exogenous metabolic activation and found to be negative up to the HDT ( 80 F g/ ml) . Unscheduled DNA Synthesis ( UDS) : UDS in WI­ 38 human fibroblasts ( Accession# 000028625; Doc# 003958) : The test is positive in the absence of S9 activation at precipitating doses ( 1000­ 4000 F g/ ml) . With S9 activation, the study was negative at comparable percipitating concentrations. Other EPA Sponsored Mutagenicity Studies: Disulfoton was also included in second tier mutagenicity test battery performed at the EPA ( EPA­ 600/ 1­ 84­ 003) in 1984. Although DERs have not been prepared for these additional assays, we assess that they are acceptable for regulatory purposes. Mouse Lymphoma L5178Y TK+ / ­ forward gene mutation assay: The test was positive in the absence of S9 activation with concentration dependent and reproducible increases in mutation frequency at 40­ 90 F g/ ml; higher dose levels were cytotoxic. No mutagenic activity was seen in the presence of S9 activation up to a cytotoxic dose ( 150 F g/ ml) . Mouse Micronucleus Assay: The test is negative in Swiss Webster mice up to a lethal dose ( 8 mg/ kg) administered once daily for 2 consecutive days by intra­ peritoneal injection. No bone marrow cytotoxicity was seen. Sister Chromatid Exchange in CHO cell assay: The non­ activated test was negative up to levels ( $ 0.02% ) that caused cell cycle delay, but the test material was weakly positive at a single dose ( 0.04% ) with metabolic activation. 4.9 Neurotoxicity The neurotoxicity studies conducted on disulfoton showed cholinesterase inhibition and effects associated with cholinesterase inhibition, but no neuropathy in the hen or the rat studies. 870.6100 Acute Delayed Neurotoxicity ­ Hen CITATION: Andrews, P and Popp, A ( 1999) S S276( c. n. : Disulfoton) Study for Delayed neurotoxicity following Acute Oral Administration to Hens, EPA Guideline 81­ 7, Bayer Report No. 109423. 75 pages. November 5, 1999. MRID 44996401. Unpublished. SPONSOR: Bayer Corp. , Agriculture Division, 8400 Hawthorn Road, Kansas City, MO 64120­ ­ 20­ Disulfoton/ June/ 2001 RED Toxicology Chapter 0013. Telephone: 816­ 242­ 2000. Dr. Premjit Halarnkar ( 816­ 242­ 2331) contact. EXECUTIVE SUMMARY: In an acute delayed neurotoxicity study in hens ( MRID# 44996401) , disulfoton was acutely administered orally to 18 LSL laying hens at 40 mg/ kg bird in a single dose. Fifteen hens were used as controls. Doses were administered in aqueous 2% Cremophor at 5 ml/ kg bird. Five to 18 minutes before administration of the disulfoton, atropine was administered s. c. ( 0.5 ml/ kg of 4% atropine sulfate) . Directly prior to the administration of the disulfoton, 0.5 ml/ kg of 10% atropine sulfate and 10% 2­ PAM chloride was injected s. c. The afternoon of day 0, 0.5 ml/ kg of 5% atropine sulfate and 5% 2­ PAM chloride was injected s. c. and again the morning and afternoon of day 1. Clinical observations were made at least daily. Forced motor activity tests were conducted by forcing the hens to run around a 12­ 13 m 2 area and rated for coordination, ataxia, and paresis. NTE studies were conducted at 24 and 48 hours on the spinal cords, sciatic nerves and ½ of the brain in each of 3 hens per group. Cholinesterase activity studies were conducted on the other ½ of the brain from each bird in the NTE study at 24 and 48 hours post treatment. . The study was conducted at 1.4 times the LD50 for hens. No typical signs of organophosphate induced delayed neuropathy was seen during the study or on microscopic examination of the treated birds at termination at 3 weeks. No inhibition was seen in the NTE study at 24 hours or 48 hours. Inhibition was low between 4% and 8% and was not considered to be indicative of OPIDP. Cholinesterase activity in the brain was inhibited 83% and 59% at 24 and 48 hours, respectively. No hens died, but by day 7 there was a decrease in body weight of over 5% . The hens slowly recovered and by the end of 3 weeks, body weight of the treatment group and of the controls did not differ. Severely uncoordinated gait was observed in all treated birds within 5 minutes of being dosed with atropine and before disulfoton treatment. The report authors attributed this abnormal gait to atropine since it lasted only for the duration of the atropine treatment ( 2 days) . However, the report authors also noted reduced motility in 1­ 3 birds for 0­ 1 day, which they attributed to disulfoton treatment. Neither statements are completely supportable because the hens were dosed with atropine and disulfoton during most of this period. However, the temporary uncoordinated gait was followed by no microscopic findings in nerve tissue and no other signs, which supports a conclusion of no demonstrated OPIDP in hens dosed with disulfoton. Microscopic examination of the test birds showed 3 ( 25% ­ 8% in each region, grade 1) lesions in treated birds and 1 ( 11% , grade 1) in the same control brain regions. Since these lesions were similar to those found in controls from previous studies, they were considered incidental. The study supports a conclusion the disulfoton does not cause acute delayed neuropathy ( OPIDP) in hens. The study is acceptable for an acute delayed neurotoxicity study ( OPPTS# 870.6100) in hens. 870.6200 Acute Neurotoxicity ­ Rat CITATION: Sheets, LP and Lake, SG ( 1993) An acute oral neurotoxicity screening study with technical grade disulfoton ( Di­ Syston ® ) in rats Study number 92­ 412­ OB ( Miles no. 103992) . ­ 21­ Disulfoton/ June/ 2001 RED Toxicology Chapter Conducted by Miles Inc. , Agriculture Division fo Miles Inc. MRID# 42755801. Executive Summary : In an acute neurotoxicity screening study, disulfoton ( 97.8% pure) was administered in a single gavage dose to 10 male Sprague­ Dawley rats at doses of 0, 0.25, 1.5, or 5.0 mg/ kg and to 10 female Sprague­ Dawley rats at doses of 0, 0.25, 0.75 or 1.5 mg/ kg ( MRID# 42755801) . These rats were assessed for reactions in functional observational battery ( FOB) and motor activity measurements at approximately 90 minutes post­ dosing and on days 7 and 14. Cholinesterase determinations ( erythrocyte and plasma) were made at 24 hours post­ dosing. Six rats/ sex/ dose were examined for neuropathological lesions. At 0.75 mg/ kg, 4/ 10 females had muscle fasciculations. At 1.5 mg/ kg, males had muscle fasciculations, diarrhea, and sluggishness and females also had tremors, ataxia, oral staining, decreased activity/ sluggishness, decreases in motor and locomotor activity ( 38 49% of control) , and a slightly increased duration of nasal staining. One female at 1.5 mg/ kg died from cholinergic intoxication on the day of dosing. At 5.0 mg/ kg, males also had symptoms similar to those observed in females at 1.5 mg/ kg/ day, including reduced motor/ locomotor activity ( 36 45% of control) . Recovery appeared to be complete in surviving animals by Day 14. Based on the evidence of neurotoxicity ( probably associated with inhibition of cholinesterase) in females at 0.75 mg/ kg, the study LOAEL is 0.75 mg/ kg and the study NOAEL is 0.25 mg/ kg. At 0.75 mg/ kg in females, cholinesterase activities were inhibited by 53% ( erythrocyte) and 30% ( plasma) and by 75% ( erythrocyte) and 52% ( plasma) at 1.5 mg/ kg in females. At 5.0 mg/ kg in males, cholinesterase activities were inhibited by 21% ( erythrocyte) and 25% ( plasma) . The LOAEL for inhibition of cholinesterase activity is 0.75 mg/ kg and the NOAEL for inhibition of cholinesterase activity is 0.25 mg/ kg. This study is classified as core­ minimum and satisfies the guideline requirement for an acute neurotoxicity screen ( 81­ 8) . 870.6200 Subchronic Neurotoxicity Screening Battery ­ Rats CITATION: L. P. Sheets and B. F. Hamilton ( 1993) A subchronic dietary neurotoxicity screening study with technical grade disulfoton ( Di­ Syston ® ) in Fischer 344 rats. Testing lab. : Miles Inc. Study# 92­ 472­ NS ( 106332) . Date: 9/ 23/ 1993. MRID# 42977401. Unpublished study. EXECUTIVE SUMMARY: In a subchronic neurotoxicity study ( MRID# 42977401) , disulfoton ( 98.7 99.0% pure) was administered in the diet to 12 male and 12 female Fischer 344 rats at dietary levels of 0, 1, 4, or 16 ppm ( 0, 0.063, 0.270, and 1.08 mg/ kg/ day in males and 0, 0.071, 0.315, and 1.31 mg/ kg/ day in females) . Of these 12 rats/ sex/ dose, 6/ sex/ dose were used for a neurohistopathological examination at the end of the study. At 4 ppm, females had muscle fasciculations, urine staining, and increased food consumption ( approximately 110% of control) . At 16 ppm, both males and females had increased reactivity, perianal staining, tremors, increased defecation, decreased forelimb grip strength ( 37 86% of control) , decreased motor and locomotor activity ( 39 71% of control) , decreased body weight gain ( 81 83% of control) , and corneal opacities. At 16 ppm, males also had muscle fasciculations and appeared sluggish, and one female died due to cholinergic intoxication. The study LOAEL is 4 ppm ( 0.315 mg/ kg/ day) and the study NOAEL is 1 ppm ( 0.071 mg/ kg/ day) , ­ 22­ Disulfoton/ June/ 2001 RED Toxicology Chapter based on clinical signs in females consistent with neurotoxicologic effects of cholinesterase inhibition. Erythrocyte, plasma, and brain cholinesterase activities were inhibited by 15 23% , 59 80% , and 87 100% in females at 1, 4, and 16 ppm, respectively, and 20 67% and 66 100% in males at 4 and 16 ppm, respectively. Males at 1 ppm had a statistically significant inhibition of erythrocyte cholinesterase at 13 weeks ( 15% inhibition) ; other cholinesterase activities in males at 1 ppm were not significantly affected. The LOAEL for inhibition of cholinesterase activity is 1 ppm and the NOAEL for inhibition of cholinesterase activity is less than 1 ppm. This study is classified as core­ guideline and satisfies the guideline requirement for a subchronic neurotoxicity screen ( 82­ 7) . 4.10 Metabolism Disulfoton is rapidly absorbed and excreted. Three minor oxidative metabolites ( Di­ Syston sulfone, Di­ Syston oxygen analogue sulfoxide, and Di­ Syston oxygen analog sulfone) were identified. Sex­ related differences in pattern of these metabolites and differences between the single dose and the repeat dose groups were attributed to differences in metabolic rates, rather than different metabolic pathways. 870.7485 Metabolism ­ Rat CITATION: Lee, SGK, Hanna, LA, Johnston, K and Ose, K ( 1985) Excretion and Metabolism of Di­ syston ® in Rats. . Study# 90946. Dated December 9, 1985, September 20, 1988, May 17, 1990 September 26, 1990 and April 29, 1992. Conducted by Mobay Corp. MRID# 42565101. EXECUTIVE SUMMARY: The aborption, distribution, metabolism and excretion of Di­ systion ® were studied in groups of male and female Sprague Dawley rats administered a single dose of 0.2 or 1.0 mg/ kg Di­ syston ® ­ ­ ethylene­ 1­ 14 C, or a 14­ day repeat oral dose of 0.2 mg/ kg unlabeled Di­ Syston ® followed by 0.2 mg/ / kg [ 14 C ] ­ labeled Di­ Syston ® on day 15. . [ 14 C ] ­ Di­ Syston ® was rapidly absorbed, distributed, metabolized completely and eliminated in rats under all dosing regimens. Over 95% of the recovered label was excreted in the urine in all groups, and excretion was approximately 90% complete within24 hours of dosing. Less than 2% of the recovered label was in the feces. Bioaccumulation was also not observed, with # 0.3% of the radiolabel recovered in the tissues and # 1% in the carcass. A major metabolite ( 43­ 60% of the radioactivity in the urine) and a minor metabolite ( 6­ 20% of the urinary radioactivity) were produced by hydrolysis of oxidative metabolites. These metabolites were identified as sulfonyl [ 1­ ( ethylsulfonyl) ­ 2­ ( methylsulfinyl) ethane ] and sulfinyl [ 1 ­ ( ethylsulfinyl) ­ 2­ ( methylsulfinyl) ethane ] , respectively. Three minor oxidative metabolites ( Di­ Syston sulfone, Di­ Syston oxygen analogue sulfoxide, and Di­ Syston oxygen analog sulfone) were identified. Sex­ related differences in pattern of these metabolites and differences between the single dose and the repeat dose groups were attributed to differences in metabolic rates, rather than different metabolic pathways. A metabolic pathway for Di­ Syston was proposed. ­ 23­ Disulfoton/ June/ 2001 RED Toxicology Chapter Study classification: The study is classified as acceptable. The study satisfies the registration requirements under Guideline 85­ 1 ( and Addendum 7) for metabolism in rats. Althjough there were minor deficiencies in the study, they did not affect the overall study results and conclusion ( see Reviewer s Discussion, Section E) . A metabolite was not fully characterized, however, the testing laboratory inducated that after using different solvents the metabolite co­ chromatographed with a oxygenated hydrolytic product of disulfoton, 1­ ( ethylsulfonyl) ­ 2­ ( methylsulfinyl) ethane and material at the origin co­ chromatographed with 1­ ( ethylsulfinyl) ­ 2­ ( methylsulfinyl) ethane. 870.7600 Dermal Absorption ­ Rats Dermal absorption was determined to be 36% . Since the total amount absorbed may contribute to the toxicity, total absorption at the mid­ dose and after the10 hour skin wash was used for risk assessment ( 32.7% plus 3.5% residue absorbing after 10 hours) . CITATION: Warren, D. L. ( 1994) Dermal Absorption of 14 C­ Disulfoton from the DISYSTON 8 Formulation. Miles, Stilwell, KS. Study No. 94­ 722­ YP. August 30, 1994. MRID 43360201. Unpublished. EXECUTIVE SUMMARY: In a dermal absorption study ( MRID 43360201) 14 C­ Disulfoton ( 99.3% a. i. , Specific activity 53 mCi/ mmol; cold disulfoton 86.5% a. i. ) in 150 F l emulsion was applied to clipped backs ( . 15 cm 2 area) of 4 male rats/ dose/ group at dose levels of 0.85, 8.5, and 85 F g/ cm 2 for 1, 4, and 10 hours ( MRID# 43360201) . At the 10th hour all the skins were washed to terminate the exposure. At the termination of exposure, these animals were kept for an additional 168 hours to determine kinetics of absorption and excretion of the material remaining on/ in the skin following washing. Following the application of the material, the rats were placed individually in metabolism cages and total urine and feces collected separately. Following the wash of the application site, the urine and feces were collected in 24 hour aliquots. Disulfoton is well absorbed and about 31 ­ 37% and 2.7 ­ 3.3% of the administered dose was excreted in the urine and feces, respectively. Ten to 30% of the applied dose evaporated during the 10 hours exposure period in all groups. Skin residues as percent of administered dose increased with dose and decreased with time in all groups. The % absorbed increased with time, essentially equal with time. At low dose, the % absorption at 1, 4, and 10 hours was 5.9, 13.7 and 26% ; at mid dose it was 4.6, 15.9, and 32.7% ; and at high dose 3.6, 12.5 and 25.6% , respectively. The study is classified as Acceptable and satisfies the guideline requirement for dermal penetration study ( 85­ 3) in the rat. 4.11 Special/ other Studies Special studies on disulfoton included 3­ 5 day inhalation, 6­ months cholinesterase study and a 3­ day dermal studies in rats. The 3­ 5 day inhalation study showed an acute LC50, and a LOAEL for cholinesterase inhibition. The 6­ month cholinesterase study was required because the chronic/ carcinogenic study in rats did not show a NOAEL for cholinesterase. The 3­ day dermal ­ 24­ Disulfoton/ June/ 2001 RED Toxicology Chapter study was conducted to aid in the assessment of pesticide handler risk and to determine a NOAEL in the rat for a formulated product. All three studies were used for risk assessment. 870.3100 and Non­ Guideline Acute and 3­ 5 Day Inhalation Study/ Rats CITATION: Anonomus ( 1978) Acute and 5­ Day Inhalation in the rat with disulfoton. Study laboratory: Bayer AG Instit. Study# 7827. Date: 9/ 27/ 78. MRID# 00147754. Unpublished. Executive Summary : Disulfoton, technical ( 94.4% ) was administered to 20 Wistar rats/ sex/ group at 0, 34, 48, 51, 64, 78 or 96 F g/ L for males and 0, 3.4, 5, 7, 10, 13 or 20 F g/ L for females for 4 hours in a nose only experiment ( MRID No. : Accession# 258569) . The NOAEL for death was 34 F g/ L for males and 3.4 F g/ L for females. LC50 for males was 60 F g/ L with animals dying at $ 48 F g/ L. The LC50 for females was 15 F g/ L with animals dying at $ 5 F g/ L. In addition, 10 rats/ sex were administered disulfoton for 4 hour/ day for 5 days by inhalation at 0, 0.5, 1.8 or 9.8 F g/ L in a nose only exposure; the following cholinesterase inhibition studies were conducted on 5 rats/ sex/ group after one of the five 4 hour exposures in the 5 day study. After 1 exposure in males, plasma cholinesterase inhibition ( $ 17% ) occurred at $ 1.8 F g/ L and erythrocyte cholinesterase inhibition ( $ 15% ) occurred at 9.8 F g/ L. After 1 exposure in females, plasma cholinesterase inhibition ( $ 40% ) occurred at $ 1.8 F g/ L and erythrocyte cholinesterase inhibition ( $ 23% ) occurred at $ 9.8 F g/ L. After 3 to 5 exposures in males, plasma cholinesterase inhibition was reduced ( $ 40% ) and erythrocyte cholinesterase inhibition ( $ 16% ) at $ 1.8 F g/ L. After 3 to 5 exposures in females, plasma cholinesterase inhibition was reduced ( $ 31% ) at $ 0.5 F g/ L and erythrocyte cholinesterase inhibition was reduced ( $ 17% ) at $ 1.8 F g/ L. No deaths occurred after one 4 hours exposure at 9.8 F g/ L in either males or females, however, deaths occurred in females after the 3rd exposure at 9.8 F g/ L. The acute inhalation NOAEL/ LOAEL for males and females are 0.0005/ 0.0018 mg/ L based on increased plasma cholinesterase inhibition and NOAEL/ LOAEL of 0.0018/ 0.0098 mg/ L for males and females based on increased erythrocyte cholinesterase inhibition after 1 exposure . After 3 to 5 exposures, males showed NOAEL/ LOAEL of 0.0005/ 0.0018 mg/ L based on increased plasma and erythrocyte cholinesterase inhibition. Females showed NOAEL/ LOAEL of < 0.0005/ 0.0005 mg/ L based on increased plasma cholinesterase inhibition after 3 to 5 exposures and the NOAEL/ LOAEL are 0.0005/ 0.0018 mg/ L based on increased erythrocyte cholinesterase after 3 to 5 exposures . The study is acceptable under Guideline 81­ 3 for acute inhalation in rats and is acceptable for a NG 3­ 5­ day inhalation study in rats. Non­ Guideline Special 6­ Month Cholinesterase Study CITATION: W. R. Christenson, B. S. Wahle ( 1993) Technical grade disulfoton ( Di­ Syston ® ) : A ­ 25­ Disulfoton/ June/ 2001 RED Toxicology Chapter special 6­ month feeding study to determine a cholinesterase no­ observed­ effect level in the rat. Study# 91­ 972­ IR, ( 12/ 3/ 1993) , conducted at Miles Inc. , Agricultural Division, Toxicology Stilwell, Kansas for Miles Inc. , Agricultural Division, Kansas City, Missouri. MRID No. : 43058401. Unpublished Report. EXECUTIVE SUMMARY: In a 6­ month study designed to establish a NOAEL and LOAEL for cholinesterase inhibition, technical grade disulfoton ( 98­ 99% pure) was administered in the diet to 35 male and female Fischer 344 rats for up to 6 months at levels of 0, 0.25, 0.5 or 1 ppm ( approximate doses of 0, 0.02, 0.03 or 0.06 mg/ kg/ day for males and 0, 0.02, 0.03 or 0.07 mg/ kg/ day for females) ( MRID# 43058401) . At the end of 2, 4 and 6 months, 10 rats/ sex/ dose were taken for blood and brain cholinesterase assays. Statistically significant inhibition of cholinesterase activity was observed in erythrocytes in females at all doses ( 3­ 14% inhibition, 11­ 17% inhibition, and 23­ 29% inhibition at 0.24, 0.5, and 1.0 ppm, respectively. In addition, at 1.0 ppm, males had decreased erythrocyte cholinesterase activity ( 10­ 16% inhibition) and females had decreased plasma ( 8­ 17% inhibition) and brain ( 7­ 13% inhibition) cholinesterase activities. However, biologically significant and statistically significant inhibition of cholinesterase activity was observed only in the plasma, erythrocytes and brain of females at 1.0 ppm. No biologically significant inhibition of cholinesterase activity was observed in males. The LOAEL for inhibition of cholinesterase activity was 1.0 ppm is based on a 23­ 29% inhibition of erythrocyte, 12­ 17% inhibition of plasma and 13% inhibition of brain cholinesterase in females. The NOAEL is 0.5 ppm ( 0.03 mg/ kg/ day) . No biological meaningful cholinesterase inhibition was observed in males at any dose level. Body weight, food consumption, and clinical signs were also monitored, but showed no treatment related effects. Based on these few parameters, no systemic effects were observed at any dose level and the NOAEL for systemic toxicity was 1.0 ppm ( 0.06 mg/ kg/ day for males and 0.07 mg/ kg/ day for females) . Core classification: The special non­ guideline study is acceptable for the requested 6­ months cholinesterase study in rats. Non Guideline 3­ Day Dermal study ­ Rats CITATION: Croutch, CR and Sheets, LP ( 2000) . Repeat­ Exposure ( 3­ Day) Dermal Toxicity Study with 1% G Di­ Syston ® ) in Rats. Testing Laboratory name Bayer Corp. , Stilwell, KA. Laboratory report number: 109956, Study# 00­ S22­ BS. October 16, 2000. MRID# 45239602. Unpublished SPONSOR: Bayer Corp. , Stilwell KA EXECUTIVE SUMMARY : In a 3­ day dermal rat study ( MRID# 45239602) disulfoton, granular, 1% a. i. ( 1% G Di­ Syston ® ) ) was administered dermally to 5 Wistar ( Crl: WI( HAN) BR) rats/ sex/ dose at 0, 50, 100, 200 or 500 mg/ kg/ day ( equivalent to 0, 0.5, 1.0, 2.0 or 5.0 mg a. i. / kg/ day) . Plasma and erythrocyte cholinesterase was measured at 24 hours after the first and day ­ 26­ Disulfoton/ June/ 2001 RED Toxicology Chapter 3 dose. Brain cholinesterase was measured at termination on day 4. Test material was ground and applied to plastic backed gauze, moistened with water, applied to the shave the test site ( about 10% of the body surface) , then secured with a bandage. The animals were exposed dermally for 6 hour per day with washing at the end of the exposure period. No clinical signs were noted or body weight decrement. No other signs of toxicity were noted, but the study was designed to determine cholinestersase depression only. After 1 day of dosing, the NOAEL in males was 200 mg/ kg and the LOAEL was 500 mg/ kg based on biologically significant 31% erythrocyte cholinesterase inhibition which was not statistically significant. After 1 day of dosing the NOAEL in females was 100 mg/ kg and the LOAEL was 200 mg/ kg based on biologically significantly increased inhibition of plasma cholinesterase ( 36% ) . After 3­ days of dermal dosing the NOAEL in males was 100 mg/ kg/ day and LOAEL was 200 mg/ kg/ day based on a increase in brain cholinesterase inhibition of 21% ( statistically significant) . After 3­ day of dosing the NOAEL in females was 50 mg/ kg/ day and the LOAEL was 100 mg/ kg/ day based on statistically significant plasma and brain cholinesterase inhibition of 37% and 18% , respectively. The overall NOAEL of 100 mg/ kg/ day ( equivant to 1.0 mg a. i. / kg) with a LOAEL of 200 mg/ kg/ day ( equivalent to 2.0 mg a. i. / kg) based female plasma cholinesterase deprssion for 1 day of dosing. After 3 days of dosing the NOAEL was 50 mg/ kg/ day ( equivalent to 0.50 mg a. i. / kg/ day) with a LOAEL of 100 mg/ kg/ day ( equivalent to 1.0 mg a. i. / kg/ day) based on depressed plasma and brain cholinesterase in females. The study is acceptable for a ( NG) 1­ day or 3­ day dermal study in the rat. 5.0 TOXICITY ENDPOINT SELECTION 5.1 See Section 8.2 for Endpoint Selection Table. 5.2 Dermal Absorption The test material was applied to the backs of rats at 0.85, 8.5, and 85 F g/ cm 2 ( approximately 0.051, 0.51 and 5.1 mg/ kg) . The percent of absorbed dose after the skin wash 10 hours post­ application was approximately 36% at the mid­ dose ( MRID# 43360201) . Dermal Aborption Factor: 36% The HIARC indicated that dermal absorption of 36% , obtained after 10 hours exposure at a concentration of 8.5 F g/ cm 2 ( 0.51 mg/ kg) , should be used for correcting oral dosing to dermal dosing. The HIARC concurred with the TES Committee on this approach for the use of the dermal absorption factor. HIARC deviated from the standard practice of using the 10­ hour dermal absorption value from the lowest application rate in this case because of the lack of a coherent pattern of absorption normally observed in dermal absorption studies. In most cases, the lowest application rate results in the highest dermal absorption rate, with declining absorption at higher applications. This is assumed to reflect overloading of the site of application. In as much as there was no dose­ related pattern to the percent of disulfoton absorbed, HIARC elected to use the 36% absorption rate to reduce the likelihood of underestimation. ­ 27­ Disulfoton/ June/ 2001 RED Toxicology Chapter 5.3 Classification of Carcinogenic Potential The HED RfD/ Peer Review classified disulfoton as a Group E Chemical­ Not Classifiable to Carcinogenicity based on the lack of evidence of carcinogenicity study in mice and rats at dose levels adequate to test for carcinogenicity. 5.3.1 Quantification of Carcinogenic Potential Not applicable 6.0 FQPA Considerations Adequacy of Toxicology Database The toxicology database is adequate for FQPA considerations. On January 19, 2000, the HIARC reviewed the submitted acute delayed neurotoxicity study with disulfoton in the hen which was previously identified as data gap. The HIARC determined that this study is acceptable and therefore, the toxicology database is now adequate according to the standard Subdivision F and/ or OPPTS Series 870 Guideline requirements for a food­ use chemical. a. Evaluation of Neurotoxicity The repeat acute delayed neurotoxicity study in hens ( required by HIARC during the Hazard Assessment of the Organophosphates; May 12­ 14, 1998) has been received and reviewed, and found to be negative for organophosphate induced delayed neuropathy ( OPIDP) . There are also acute and subchronic neurotoxicity studies with disulfoton in rats. The acute study shows neurotoxicity in the form of tremors and muscle twitching and decreased motor activity, but no neuropathology ( MRID No. 42755801) . The subchronic study shows similar neurotoxicity and nominal increased incidence of neuropathy in the form of nerve fiber degeneration in the optic nerve and thoracic spinal cord at the highest dose tested ( MRID No. 42977401) . On January 19, 2000, the HIARC concluded that the differences in the effects observed between the high dose animals and control animals in the subchronic neurotoxicity study in rats, were not sufficiently great to indicate that a treatment­ related effect had occurred. b. Developmental Toxicity In a prenatal developmental toxicity study in rats, developmental toxicity occurred only in the presence of maternal toxicity ( MRID No. 00129458) . ­ 28­ Disulfoton/ June/ 2001 RED Toxicology Chapter In a prenatal developmental toxicity study in rabbits, there was no evidence of developmental toxicity even at the highest dose tested ( MRID No. 00147886) . c. Reproductive Toxicity In a two­ generation reproduction study rats, the effects in pups were caused by maternal toxicity and not the direct toxicity of disulfoton on pups ( MRID No. 44440801) . 6.1 Special Sensitivity to Infants and Children Prenatal developmental toxicity studies in rats and rabbits provided no indication of increased susceptibility of rat or rabbit fetuses to in utero exposure to disulfoton. There was no indication of increased susceptibility in the offspring as compared to parental animals in the two generation reproduction study. In these studies, effects in the fetuses/ offspring were observed only at or above treatment levels which resulted in evidence of maternal/ parental toxicity. 6.2 Recommendation for a Developmental Neurotoxicity Study On January 19, 2000, the HIARC concluded that although a developmental neurotoxicity study ( DNT) with disulfoton in rats has been required as part of the Data­ Call­ In for select organophosphates, this requirement was not, however, triggered by a special concern for the developing fetuses or young which are generally used for requiring a DNT study and an FQPA safety factor ( e. g. : neuropathy in adult animals; CNS malformations following prenatal exposure; brain weight or sexual maturation changes in offspring; and/ or functional changes in offspring) . 7.0 RERERENCES 00069966 Carpy, S. ; Klotzsche, C. ; Cerioli, A. ( 1975) Disulfoton: 2­ Year Feeding Study in Rats. Sandoz, Ltd. , Switzerland. Report No. 47069. December 15, 1976. MRID 00069966. Unpublished. 00073348 Hoffman, K. ; Weischer, C. H. ; Luchaus, G. ; et al. ( 1975) S 276 ( Disulfoton) Chronic Toxicity Study in Dogs ( Two­ year Feeding Experiment) . Bayer, AG, W. Germany. Report No. 45287. December 15, 1976. MRID 00073348. Unpublished. 00129456 Hayes, R. H ( 1983) Oncogenicity study of disulfoton technical on mice. Corporate Toxicology Department, Mobay Chemical Corporation, Stilwell, KS. Study No. 80­ 271­ 04. August 10, 1983. MRID 00129456. Unpublished study. 00129458 Lamb­ DW and Hixson­ EJ ( 1983) Embyrotoxic and teratogenic effects of Disulfoton. Study# 81­ 611­ 02 submitted by Mobay Chem. Corp. May 13, 1983. MRID# : 00129458. Unpublished Report. ­ 29­ Disulfoton/ June/ 2001 RED Toxicology Chapter 00146873 Hayes, R. H ( 1985) Chronic feeding/ oncogenicity study of technical disulfoton ( Di­ SYSTON) with rats. Mobay Chemical Corporation, Stilwell, KS. Study No. 82­ 271­ 01. June 25, 1985. MRID # s 00146873. Unpublished. and Supplementary data upgrading MRID# 00146873 from supplementary to acceptable on the Harderian gland ( MRID# 41850001) and optical and optic nerve lesions ( MRID# 41850002) . 00147754 CITATION: Anonomus ( 1978) Acute and 5­ Day Inhalation in the rat with disulfoton. Study laboratory: Bayer AG Instit. Study# 7827. Date: 9/ 27/ 78. MRID# 00147754. Unpublished. 00147886 Tesh­ JM et al. ( 1982) S276: Effects of oral administration upon pregnancy in the rabbit. An unpublished report ( Bayer No. R 2351) prepared by Life Science Research, Essex, England and submitted to Bayer AG, Wuppertal, Germany. Dated December 22, 1982. MRID# 00147886. Unpublished Report. 00157511 Hixson, EJ and Hathaway, TR ( 1986) Effect of disulfoton ( Di­ Syston ® ) on reproduction in the rat. Conducting laboratory: Mobay Chem. Date: 2/ 12/ 86. Study# 82­ 671­ 02. MRID# 00157511. Unpublished Study. 00162338 Flucke, W. ( 1986) Study of Subacute Dermal Toxicity to Rabbits. Bayer AG, Fachbereich Toxikologie, Wuppertal ­ Elberfeld, F. R. Germany. Study No. : 14747. June 20, 1986. MRID 00162338. Unpublished. 41224301 Shiotsuka, RN ( 1989) Subchronic inhalation study of technical grade disulfoton ( Di­ Syston ® ) inhalation in rats. Testing Lab: Mobay Corp. Study# 88­ 141­ AU/ 99648. Date: 7/ 31/ 89. MRID# 41224301. Unpublished study. 42565101 Lee, SGK, Hanna, LA, Johnston, K and Ose, K ( 1985) Excretion and Metabolism of Di­ syston ® in Rats. . Study# 90946. Dated December 9, 1985, September 20, 1988, May 17, 1990 September 26, 1990 and April 29, 1992. Conducted by Mobay Corp. MRID# 42565101. 42755801 Sheets, LP and Lake, SG ( 1993) An acute oral neurotoxicity screening study with technical grade disulfoton ( Di­ Syston ® ) in rats Study number 92­ 412­ OB ( Miles no. 103992) . Conducted by Miles Inc. , Agriculture Division fo Miles Inc. MRID# 42755801. Unpublished. 42977401 Sheets, LP and Hamilton, BF ( 1993) A subchronic dietary neurotoxicity screening study with technical grade disulfoton ( Di­ Syston ® ) in Fischer 344 rats. Testing lab. : Miles Inc. Study# 92­ 472­ NS ( 106332) . Date: 9/ 23/ 1993. MRID# 42977401. Unpublished. 43058401 W. R. Christenson, B. S. Wahle ( 1993) Technical grade disulfoton ( Di­ Syston ® ) : A ­ 30­ Disulfoton/ June/ 2001 RED Toxicology Chapter special 6­ month feeding study to determine a cholinesterase no­ observed­ effect level in the rat. Study# 91­ 972­ IR, ( 12/ 3/ 1993) , conducted at Miles Inc. , Agricultural Division, Toxicology Stilwell, Kansas for Miles Inc. , Agricultural Division, Kansas City, Missouri. MRID No. : 43058401. Unpublished Report. 43360201 Warren, D. L. ( 1994) Dermal Absorption of 14 C­ Disulfoton from the DISYSTON 8 Formulation. Miles, Stilwell, KS. Study No. 94­ 722­ YP. August 30, 1994. MRID 43360201. Unpublished. 44248002 Jones, R. D. and T. F. Hastings ( 1997) Technical grade Disulfoton: A chronic toxicity feeding study in the Beagle dog. Bayer Corporation, Stillwell, KS. Study Number 94­ 276­ XZ. Report No. 107499. February 5, 1997. MRID 44248002. Unpublished. 44440801 Astroff, A Barry ( 1997) A Two Generation Reproductive Toxicity Study with Disulfoton Technical ( Disyston ® ) in the Sprague Dawley Rat. Laboratory name Bayer Corp. , Stilwell, KA. Laboratory report number: 95­ 672­ FZ, report# 108002, File 8368. November 19, 1997. MRID# 44440801. Unpublished 44996401 Andrews, P and Popp, A ( 1999) S S276( c. n. : Disulfoton) Study for Delayed neurotoxicity following Acute Oral Administration to Hens, EPA Guideline 81­ 7, Bayer Report No. 109423. 75 pages. November 5, 1999. MRID 44996401. 45239601 Flucke, W ( 1988) S 276 Technical grade Disulfoton: Study of the Subacute Dermal Toxicity to Rabbits. Bayer AG. , Germany. Study Number 98347. Report No. 116342, January 5, 1988. MRID 45239601. Unpublished. 45239602 Croutch, CR and Sheets, LP ( 2000) . Repeat­ Exposure ( 3­ Day) Dermal Toxicity Study with 1% G Di­ Syston ® ) in Rats. Testing Laboratory name Bayer Corp. , Stilwell, KA. Laboratory report number: 109956, Study# 00­ S22­ BS. October 16, 2000. MRID# 45239602. Unpublished ­ 31­ Disulfoton/ June/ 2001 RED Toxicology Chapter 8.0 APPENDICES Tables for Use in Risk Assessement ­ 32­ Disulfoton/ June/ 2001 RED Toxicology Chapter 8.1 Toxicity Profile Summary Tables 8.1.1 Acute Toxicity Data Table on disulfoton Guideline No. Study Type MRID # ( S) . Results Toxicity Category 870.1100 Acute Oral 00139595, Doc# 003958, p41 LD50 = M: 6.2 mg/ kg; F: 1.9 mg/ kg I 870.1200 Acute Dermal Acc# 07793, Doc# 03958, p71 & 004223, p24 LD50 = M: 15.9 mg/ kg; F: 3.6 mg/ kg I 870.1300 Acute Inhalation 00147754, Doc# 05789 LC50 = M: 0.06 mg/ L; F: 0.015 mg/ L I 870.2400 Primary Eye Irritation Data requirement waived. Doc# 03958, p12; 004223, p14 Defaults to most severe category 870.2500 Primary Skin Irritation Data requirement waived. Doc# 03958, p12; 004223. p14 Defaults to most severe category 870.2600 Dermal Sensitization Data requirement waived. Doc# 03958, p12 Defaults to most severe category 870.6100 Acute Delayed Neurotoxicity/ Hen 44996401, Doc# 013957 Negative for OPIDP and NTE effects 870.6200 Acute Neurotoxicity/ Rat 42755801 Reversible neurotoxic signs with cholinesterase inhibition NOAEL = 0.25 mg/ kg LOAEL = 0.75 mg/ kg 8.1.2 Subchronic, Chronic and other Toxicity Tables Table A and B are respectively, the Toxicity Profile for Disulfoton Technical and a 1% granular formulation ­ 33­ Disulfoton/ June/ 2001 RED Toxicology Chapter used for Short­ Term occupational/ residential exposure. Table A: Toxicity Profile for Disulfoton, Technical Guideline No. / Type of Study MRID No. ( year) / Classification/ Doses Results Non­ guideline Acute Inhalation ­ Rat ( 1 day in a 3­ 5 day exposure study) 00147754 ( 1978) Acceptable 0, 0.0005, 0.0018 or 0.0098 mg/ mL NOAEL ( ChE Inhibition) = 0.0005 mg/ L LOAEL ( ChE Inhibition) = 0.0018 mg/ L 21­ Day Dermal Toxicity­ Rabbit 00162338 ( 1986) Acceptable 0, 0.4, 1.6 or 6.5 mg/ kg/ day NOAEL ( Systemic) = 1.6 mg/ kg/ day LOAEL ( Systemic) = 6.5 mg/ kg/ day NOAEL ( ChE Inhibition) = 0.4 mg/ kg/ day LOAEL ( ChE Inhibition) = 1.6 mg/ kg/ day 21­ Day Dermal Toxicity­ Rabbit 45239601 ( 1988) Acceptable 0, 0.8, 1.0, or 3.0 mg/ kg/ day NOAEL ( Systemic) = 1.0 mg/ kg/ day LOAEL ( Systemic) = 3.0 mg/ kg/ day NOAEL ( ChE Inhibition) = 0.8 mg/ kg/ day LOAEL ( ChE Inhibition) = 1.0 mg/ kg/ day 870.3465 Subchronic Inhalation ­ Rat 41224301 ( 1989) Acceptable 0, 0.000018, 0.00016, or 0.0014 mg/ mL NOAEL = ( ChE Inhibition) = 0.00016 mg/ L LOAEL = ( ChE Inhibition) = 0.0014 mg/ L Subchronic­ Feeding­ Rat Data waived because an adequate chronic study was available Subchronic­ Feeding­ Dog Data waived because an adequate chronic dog study was available 870.4100 Chronic­ Feeding­ Dog ( 1­ year) 44248002 ( 1997) Acceptable Males­ 0, 0.015, 0.121 or 0.321 mg/ kg/ day; Females­ 0, 0.013, 0.094 or 0.283 mg/ kg/ day NOAEL ( ChE Inhibition) = 0.013 mg/ kg/ day LOAEL ( ChE Inhibition) = 0.094 mg/ kg/ day ­ 34­ Disulfoton/ June/ 2001 RED Toxicology Chapter 870.4100 Chronic­ Feeding­ Dog ( 1­ year) 00073348 ( 1975) Acceptable 0, 0.0125, 0.025 or 0.05/ 0.125/ 0.2 mg/ kg/ day NOAEL = ( ChE Inhibition) = 0.025 mg/ kg/ day LOAEL ( ChE Inhibition) = 0.05 mg/ kg/ day 870.4300 Chronic toxicity/ Carcinogenicity­ Rat 00146873; 41850001; 41850002 ( 1985) Acceptable 0, 0.04, 0.165 or 0.650 mg/ kg/ day NOAEL ( systemic) = 0.04 mg/ kg/ day LOAEL ( systemic) = 0.165 mg/ kg/ day ( HDT) NOAEL ( ChE Inhibition) = Not demonstrated LOAEL ( ChE Inhibition) = 0.04 mg/ kg/ day ( LDT) No evidence of carcinogenicity 870.4300 Chronic toxicity/ Carcinogenicity­ Rat 00069966 ( 1976) Unacceptable Males­ 0, 0.0215/ 0.19, 0.456 or 0.0893 mg/ kg/ day; Females­ 0, 0.0267/ 0.196, 0.0419 or 0.103 mg/ kg/ day NOAEL ( ChE inhibition) = 0.042 mg/ kg/ day LOAEL ( ChE inhibition) = 0.103 mg/ kg/ day 870.4200 Carcinogenicity ­ Mouse 00129456; 00139598 ( 1983) Acceptable 0, 0.15, 0.6 or 2.4 mg/ kg/ day NOAEL ( ChE Inhibition) = 0.6 mg/ kg/ day LOAEL ( ChE Inhibition) = 2.4 mg/ kg/ day ( HDT) No evidence of carcinogenicity 870.3700 Developmental Toxicity­ Rat 00129458 ( 1983) Acceptable 0, 0.1, 0.3 or 1.0 mg/ kg/ day Maternal NOAEL = 0.1 mg/ kg/ day LOAEL = 0.3 mg/ kg/ day Developmental NOAEL = 0.3 mg/ kg/ day LOAEL = 1.0 mg/ kg/ day 870.3700 Developmental Toxicity­ Rabbit 00147886 ( 1982) Acceptable 0, 0.3, 1.0 or 3.0 mg/ kg/ day Maternal NOAEL = 1.0 mg/ kg/ day LOAEL = 1.5 mg/ kg/ day Developmental NOAEL= > 3.0 mg/ kg/ day LOAEL = > 3.0 mg/ kg/ day ­ 35­ Disulfoton/ June/ 2001 RED Toxicology Chapter 870.3800 Reproductive Toxicity ­ Rat 44440801 ( 1997) Acceptable 0, 0.25, 0.10 or 0.45 Parental/ Systemic: NOAEL = Not established LOAEL = 0.025 mg/ kg/ day ( LDT) Offspring NOAEL = 0.10 mg/ kg/ day LOAEL = 0.45 mg/ kg/ day ( HDT) 870.3800 Reproductive Toxicity ­ Rat 00157511 ( 1986) Acceptable 0, 0.04, 0.12 or 0.36 mg/ kg/ day Parental/ Systemic: NOAEL = 0.04 mg/ kg/ day LOAEL = 0.12 mg/ kg/ day Offspring NOAEL = 0.04 mg/ kg/ day LOAEL = 0.12 mg/ kg/ day 870.5100 Gene Mutation ­ Salmonella Acc# 00028625, Doc# 003958, 012190 ( 1979) Acceptable Non­ mutagenic ( ± ) activation. 870.5300 Gene Mutation ­ HGPRT 40638401 ( 1988) Unacceptable 0.001­ 10.0 F L/ mL Assumed positive because tested at partially soluble conditions. Response was greater ( ­ ) activation. 870.5395 Mouse micronucleus Chromosomal aberrations 43615701, Doc# 012292 ( 1995) Acceptable 8 mg/ kg Non­ mutagenic ( ± ) activation. 870.5500 Bacterial DNA Damage/ Repair 00146894, Acc# 072293, Doc# 004698 ( 1983) Acceptable 625­ 10000 F g/ plate Non­ mutagenic ( ± ) activation 870.5577 Mitotic Recombination Acc# 00028625, Doc# 003958, 012190 ( 1979) Acceptable Non­ mutagenic ( ± ) activation 870.5900 Sister Chromatid Exchange 40495001 ( 1987) Acceptable 0.013 ­ 0.2 F L/ mL Mutagenic ( ­ ) activation, but non­ mutagenic ( + ) activation. 870.5900 Sister Chromatid Exchange Acc# 072293, Doc# 0044223 Acceptable up to 80 F g/ mL Non­ mutagenic ( ± ) activation ­ 36­ Disulfoton/ June/ 2001 RED Toxicology Chapter 870.5550 Unscheduled DNA Synthesis Acc# 028625, Doc# 003958 ( 1979) , Acceptable Mutagenic ( ­ ) activation, but non­ mutagenic ( + ) activation 870.5300 Mouse Lymphoma EPA­ 600/ 1­ 84­ 003 Mutagenic ( ­ ) activation, but non­ mutagenic ( + ) activation. 870.5395 Mouse Micronucleus EPA­ 600/ 1­ 84­ 003 Non­ mutagenic. 870.5900 Sister Chromatid Exchange EPA­ 600/ 1­ 84­ 003 Weakly mutagenic ( + ) activation, but non­ mutagenic ( ­ ) activation 870.6100 Acute Delayed Neurotoxicity­ Hen 44996401 ( 1999) Acceptable 40 mg/ kg No demonstrated acute delayed neuropathy ( OPIDP) 870.6200 Acute Neurotoxicity ­ Rat 42755801 ( 1993) Acceptable Males­ 0, 0.25, 1.5 or 5.0 mg/ kg; Females­ 0, 0.25, 0.75 or 1.5 mg/ kg NOAEL ( ChE Inhibition) = 0.25 mg/ kg LOAEL ( ChE Inhibition & clinical signs) = 0.75 mg/ kg/ day 870.6200 Subchronic Neurotoxicity ­ Rat 42977401 ( 1993) Acceptable Males: 0, 0.063, 0.270 or 1.08 mg/ kg/ day; Females 0, 0.071, 0.315 or 1.31 mg/ kg/ day NOAEL ( Clinical signs) = 0.071 mg/ kg/ day LOAEL ( Clinical signs) = 0.315 mg/ kg/ day ( HDT) NOAEL ( ChE Inhibition) = Not established. LOAEL ( ChE Inhibition) = < 0.071mg/ kg/ day ( LDT) 870.7485 Metabolism­ Rat 42565101 ( 1985) Acceptable 0.2 or 1.0 mg/ kg/ day Greater than 90 percent of the administered radioactivity was metabolized completely and eliminated within 24 hours. About 95 percent of the radiolabel was recovered in the urine, < 2 percent in the feces, < 0.3 percent in tissues and < 1 percent in the carcass. No bioaccummulation was noted. Sex related differences were attributed to different metabolic rates rather than different profiles. The ( toxicologically inactive) major and minor metabolites were produced by hydrolysis of oxygen metabolites. ­ 37­ Disulfoton/ June/ 2001 RED Toxicology Chapter 870.7600 Dermal Absorption ­ Rats 43360201 ( 1994) Acceptable 0.85, 8.5 or 85 F g/ cm 2 Dermal absorption is considered to be 36 percent after skin wash at 10 hours Non­ guideline Subacute Inhalation ­ Rat ( 3­ 5 day exposure) 00147754 ( 1978) Acceptable 0, 0.0005, 0.0018 or 0.0098 mg/ L NOAEL ( ChE Inhibition) = Not established LOAEL ( ChE Inhibition) = 0.0005 mg/ L Non­ guideline Special 6­ Month Cholinesterase ­ Rat ­ ( Non­ guideline study) 43058401 ( 1993) Acceptable Males­ 0, 0.02, 0.03 or 0.6 mg/ kg/ day; females­ 0, 0.02, 0.03, or 0.07 mg/ kg/ day NOAEL ( ChE Inhibition) = 0.03 mg/ kg/ day LOAEL ( ChE Inhibition) = 0.07 mg/ kg/ day Table B: Summary data on a 1% granular formulation used for occupational/ residential exposure Non­ guideline 3­ Day Dermal Toxicity ­ Rat 1% granular formulation Non­ guideline study) 45239602 ( 2000) Acceptable 0, 0.5, 1.0, 2.0 or 5.0 mg a. i. / kg/ day NOAEL = 1.0 mg a. i. / kg/ day LOAEL ( ChE Inhibition) = 2.0 mg a. i. / kg/ day ­ 38­ Disulfoton/ June/ 2001 RED Toxicology Chapter 8.2 Summary of Toxicological Dose and Endpoints for Disulfoton for Use in Human Risk Assessment. 1 Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF and Endpoint for Risk Assessment Study and Toxicological Effects Acute Dietary, females 13­ 50 years of age None Acute Dietary general population including infants and children NOAEL = 0.25 mg/ kg UF = 100 Acute RfD = 0.0025 mg/ kg FQPA SF = 1 aPAD = Acute RfD FQPA SF = 0.0025 mg/ kg Acute Neurotoxicity ­ Rat LOAEL = 0.75 mg/ kg based on neurotoxic signs and plasma, erythrocyte cholinesterase inhibition in female rats. Chronic Dietary all populations NOAEL = 0.013 mg/ kg/ day UF = 100 cRfD = 0.00013 mg/ kg/ day FQPA SF = 1 cPAD = cRfD FQPA SF = 0.00013 mg/ kg/ day Chronic Feeding ­ Dog LOAEL = 0.094 mg/ kg/ day based on depressed plasma, erythrocyte and corneal cholinesterase levels in both sexes and depressed brain and retinal cholinesterase levels in females. Short­ Term oral ( 1­ 7 days) NOAEL = 0.25 mg/ kg UF = 100 Acute RfD = 0.0025 mg/ kg FQPA SF = 1 aPAD = Acute RfD FQPA SF = 0.0025 mg/ kg Acute Neurotoxicity ­ Rat LOAEL = 0.75 mg/ kg based on neurotoxic signs and plasma, erythrocyte cholinesterase inhibition in female rats. Intermediate­ Term Oral ( 1 week to several months) Oral study NOAEL = 0.03 mg/ kg/ day LOC or MOE = 100 ( Residential includes the FQPA SF) Special 6­ months Cholinesterase study in Rats LOAEL = 0.07 mg/ kg/ day based on plasma, erythrocyte and brain cholinesterase inhibition in females. Short­ Term Dermal ( 1­ 7 days) ( Occupational/ residential) Dermal study NOAEL = 0.5 mg/ kg/ day UF = 100 LOC or MOE = 100 ( Occupational) LOC or MOE = 100 ( Residential, includes FQPA SF) 3­ day Dermal Study in Rats LOAEL = 1.0 mg/ kg/ day based plasma and brain cholinesterase inhibition in females. ­ 39­ Disulfoton/ June/ 2001 RED Toxicology Chapter Intermediate­ Term Dermal ( 1 week to several months) ( Occupational/ residential) Oral study NOAEL = 0.03 mg/ kg/ day Dermal absorption rate = 36% LOC or MOE = 100 ( Occupational) LOC or MOE = 100 ( Residential, includes FQPA SF) Special 6­ months Cholinesterase study in Rats LOAEL = 0.07 mg/ kg/ day based on plasma, erythrocyte and brain cholinesterase inhibition in females. Long­ Term Dermal ( Several months to life time) ( Occupational/ resi dential) Oral study NOAEL = 0.013 mg/ kg/ day Dermal absorption rate = 36% LOC or MOE = 100 ( Occupational) LOC or MOE = 100 ( Residential, includes FQPA SF) Chronic feeding study in dogs LOAEL = 0.094 mg/ kg/ day based on depressed plasma, erythrocyte and corneal cholinesterase levels in both sexes and depressed brain and retinal cholinesterase levels in females. Inhalation ( all time periods) Inhalation study NOAEL = 0.00016 mg/ mL LOC or MOE = 100 ( Occupational) LOC or MOE = 100 ( Residential, includes FQPA SF) 90­ day Inhalation study in Rats LOAEL = 0.0014 mg/ mL based on plasma, erythrocyte and brain cholinesterase inhibition in males and females. Cancer ( oral) Cancer classification: E, not likely to be a human carcinogen None No treatment related tumors in the rat or the mouse in adequate studies 1 UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD population adjusted dose ( a= acute, c = chronic) , RfD = reference dose, LOC = level of concern, MOE = margin of ex. posure ­ 40­ Disulfoton/ June/ 2001 RED Toxicology Chapter SignOff Date: 6/ 25/ 01 DP Barcode: D275193 HED DOC Number: 014606 Toxicology Branch: RRB2 ­ 41­

epa

2024-06-07T20:31:41.626229

regulations

EPA-HQ-OPP-2002-0055-0008

Supporting & Related Material

March 6, 2002 MEMORANDUM SUBJECT: DISULFOTON: Aggregate Risk Assessment (February, 2002 Revision) PC Code: 032501 DP Barcode: D280669 FROM: Christina Jarvis, Environmental Protection Specialist Richard Griffin, Biologist Reregistration Branch 2 Health Effects Division (7509C) THROUGH: Alan Nielsen, Branch Senior Scientist Reregistration Branch 2 Health Effects Division (7509C) TO: Christina Scheltema, Chemical Review Manager Reregistration Branch 3 Special Review and Reregistration Division (7508W) ** THIS DOCUMENT SUPERCEDES ALL PREVIOUS AGGREGATE RISK ASSESSMENT DOCUMENTS** The Agency, as part of the disulfoton interim reregistration eligibility decision, is required by the Food Quality Protection Act to ensure "that there is reasonable certainty that no harm will result from aggregate exposure to pesticide chemical residue, including all anticipated dietary exposures and other exposures for which there is reliable information." The following aggregate risk assessment integrates the assessments that HED has completed for disulfoton dietary and residential exposure, and has used the combined exposure estimates to evaluate the estimates of drinking water contamination modeled by the Environmental Fate and Effects Division (EFED). All routes of disulfoton exposure have been 2 considered including oral (food and water consumption), dermal (applying granules to ornamental plants), and inhalation (also during application to ornamental plants). The possibility of children ingesting treated soil around ornamental plants has also been considered in this assessment. This aggregate risk assessment also considers the probable duration( s) of exposure to disulfoton and how these intervals of exposure may coincide. The intervals of exposure considered in the disulfoton aggregate risk assessment are acute (one­ day), short­ term (one­ day to one­ month), and chronic (one­ year or more). The Agency notes that this assessment may include uses that have been or will be deleted in the future by the registrant, such as the homeowner use on vegetable gardens. Aggregate risk, and related drinking water levels of comparison (DWLOC) estimates have been made in accord with the HED interim guidance (Updated "Interim Guidance for Incorporating Drinking Water Exposure into Aggregate Risk Assessments," 8/ 1/ 99). Basis for Revision The aggregate risk assessment section of the February 7, 2000 HED risk assessment chapter (D. Anderson memo, 02/ 07/ 00) did not include exposure from residential sources, as exposure from the residential pathway alone exceeded the Agency's level of concern. Since that time, HED has revised the residential risk estimates for disulfoton, based on new toxicity and exposure data, label changes, and revisions to the Residential Standard Operating Procedures. New toxicity and exposure data were submitted by the registrant to support the currently marketed residential product (Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care®). However, since other products marketed by registrants other than Bayer are currently available, this aggregate risk assessment will consider these products as well as the Bayer 1% a. i. product. Dietary risk estimates for disulfoton have not been revised for this aggregate assessment. Estimated concentrations of disulfoton in surface and ground water are derived from the EFED memo dated 02/ 25/ 2002 (J. Wolfe memo, D280670). This memo differs from the aggregate risk assessment dated 6/ 27/ 2001 in that the estimated concentrations of disulfoton in drinking water have been recently revised. Recent Data Submitted by Bayer Toxicity Data: Based on the results of the newly submitted 3­ day dermal toxicity study in rats (MRID 45239602), the HED Hazard Identification Assessment Review Committee (HIARC) amended the dose level used to estimate risk for short­ term residential dermal exposure. The dose level for short­ term dermal risk estimates has been revised from 0.4 mg/ kg/ day to 0.5 mg/ kg/ day (NOAEL) based on plasma and brain cholinesterase inhibition observed in female rats at 1.0 mg/ kg/ day (LOAEL). The Agency requires a margin of exposure (MOE) of 100 for short­ term risk based on an uncertainty factor of 100 (10x for interspecies extrapolation and 10x for intraspecies variability). Following an evaluation of the disulfoton 3 toxicity database, the FQPA Safety Factor Committee concluded (1/ 24/ 00) that the additional safety factor of 10x required by the FQPA should be reduced to 1x. Exposure Data: The registrant also submitted a dermal and inhalation exposure study (MRID 45333401) for the residential application of Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care®. The Agency has found this study to be acceptable (on an interim basis pending clarification of several issues by the registrant), and has used the results of the study to estimate possible exposure during application. Note that aggregate risk estimates are based on residential dermal exposure only, since data indicate that inhalation exposure is negligible (all samples were either non­ detectable or less than the level of quantitation). Exposure/ Risk Estimates for Food Uses Disulfoton is currently used on a variety of food crops including asparagus, barley, soybeans, wheat, sorghum, potatoes, cotton, cabbage, lettuce, cole crops, beans, peppers, and peas. The greatest use, estimated by the Agency in lbs a. i. applied from 1987­ 98, is on cotton, wheat, potatoes, and peanuts. Dietary risk estimates for disulfoton are based on residue/ usage estimates for the above crops and on the following dose levels: aPAD: The disulfoton acute population adjusted dose (aPAD) is 0.0025 mg/ kg based on a NOAEL of 0.25 mg/ kg and an uncertainty factor of 100 (10x for interspecies extrapolation and 10x for intraspecies variability). No additional FQPA safety factor is required, based on a 1/ 24/ 00 decision by the FQPA Safety Factor Committee. Toxicological endpoints are signs of neurotoxicity, and plasma/ erythrocyte cholinesterase inhibition in female rats. cPAD: The disulfoton chronic population adjusted dose (cPAD) is 0.00013 mg/ kg/ day based on a NOAEL of 0.013 mg/ kg/ day and an uncertainty factor of 100 (10x for interspecies extrapolation and 10x for intraspecies variability). No additional FQPA safety factor is required, based on a 1/ 24/ 00 decision by the FQPA Safety Factor Committee. Toxicological endpoints are depressed plasma, erythrocyte and corneal cholinesterase levels in both sexes and depressed brain and retinal cholinesterase levels in females. Dietary risk estimates were completed February 7, 2000 (W. O. Smith memo to D. Anderson) and have not been revised since that time. The dietary risk assessment used all available information including usage data (percent crop treated), PDP and FDA monitoring data, and processing data submitted by the registrant. The 2/ 7/ 2000 dietary risk assessment is considered a refined (tier 3) assessment that cannot be amended to any significant degree (unless new data is submitted). In the acute (one­ day) dietary exposure analysis the highest exposure estimate for any population subgroup is 0.000239 mg/ kg (children 1­ 6 years old) and is taken from the 99.9th percentile of exposure since the assessment used a probabilistic (Monte Carlo) approach. The exposure estimate for children (1­ 6) is 10% of the disulfoton aPAD, or if expressed as a margin of exposure; MOE =1,044. The general U. S. population is estimated to be exposed at the level of 4 0.000176 mg/ kg (7% of the aPAD). In the chronic (one­ year to lifetime) dietary exposure analysis the highest exposure estimate for any population subgroup is 0.000005 mg/ kg/ day (children 1­ 6 years old). The exposure estimate for children (1­ 6) is 4% of the disulfoton cPAD, or if expressed as a margin of exposure; MOE = 2,600. The general U. S. population is estimated to be exposed at the level of 0.000003 mg/ kg/ day (2% of the cPAD). Exposure/ Risk Estimates for Residential Use Residential exposure scenarios (notably application by a belly grinder) with MOE values of less than 100 are not considered in the aggregate risk assessment. This also includes the use of disulfoton spikes that cannot be assessed for potential exposure due to a lack of data. The disulfoton short­ term aggregate risk assessment refers to three exposure scenarios from the 5/ 30/ 01 residential risk assessment: 1) an adult applying a granular product with a spoon, measuring scoop, shaker can, or by hand at the rate of 0.069 lb a. i./ 1,000 ft 2 to vegetables, 2) an adult applying Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care® with a measuring cup/ lid to 25 shrubs at the label rate of 0.01 lb a. i./ 4 ft shrub, and 3) a small child (toddler) ingesting soil treated with disulfoton. Residential exposure scenarios are expected to occur within the short­ term (1­ 30 day) interval. The dermal exposure estimate for application to vegetables is 0.0034 mg/ kg/ day (MOE = 150) and represents the upper­ end of exposure scenarios other than those with estimated MOEs of less than 100. The dermal exposure estimate for applying Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care® to 25 shrubs at 0.01 lb a. i./ 4 ft. shrub is 0.00033 mg/ kg/ day (MOE = 1,500). The incidental oral exposure estimate for soil ingestion by a child following treatment is 0.00013 mg/ kg/ day (MOE = 230), based on the maximum application rate of 0.3 lb ai/ 1000 ft 2 to flowerbeds, and represents the upper­ end of exposure scenarios other than those with estimated MOEs of less than 100. The incidental oral exposure estimate for soil ingestion by a child, based on the application of Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care® to flowerbeds at the maximum rate of 0.21 lb ai/ 1000 ft 2 , is 0.0000917 mg/ kg/ day (MOE = 330). Drinking Water Contamination Information Data indicate that both parent disulfoton and its degradates may be found in groundwater and surface water. However, the Agency does not consider the available groundwater and surface water monitoring data for disulfoton adequate for the purposes of risk assessment. Instead, estimates of the potential contamination of groundwater and surface water by disulfoton and the sulfone and sulfoxide degradates are based on current Agency models, and are generally considered a screening tool rather than a predictor of residues in finished drinking water. 5 Groundwater estimated drinking water concentrations (EDWCs) for total disulfoton residues (parent plus the sulfoxide and sulfone degradates) were calculated using the Agency's SCI­ GROW screening model. Using a scenario where disulfoton was applied to cotton once per season at the maximum use rate of 3 lb a. i./ A, the maximum concentration of total residues in ground water was estimated to be 1.2 ug/ L. For surface water, the Agency has used a Tier II (PRZM­ EXAMS) model with index reservoir and percent cropped area (PCA) factors to estimate levels of disulfoton and sulfoxide/ sulfone degradates in surface water at vulnerable (high run­ off) sites. Surface water modeling scenarios chosen for disulfoton are representative of high run­ off sites and are based on the highest use rates proposed by the registrant. The sites chosen are expected to represent the upper 10 th percentile for run­ off potential. For this aggregate assessment, HED refers to the peak (acute) and annual average (chronic) surface water run­ off EDWC estimates modeled by EFED for potatoes, spring wheat, barley, and cotton. Peak EDWCs for parent and degradates range from approximately 8 ug/ L in spring wheat to 39 ug/ L in barley, and annual average EDWCs for parent and degradates range from approximately 2 ug/ L in cotton to 17 ug/ L in potatoes. It should be noted that the disulfoton Quantitative Usage Analysis (S. Nako memo, 5/ 5/ 99) estimates that the major use of disulfoton is on cotton (with a weighted average of 420,000 lbs a. i./ year and an estimated maximum of 840,000 lbs a. i./ year). Potatoes are also a major use of disulfoton (with a weighted average of 120,000 lbs a. i./ year and an estimated maximum of 195,000 lbs a. i./ year). HED notes that the peak EDWC value for cotton of 55 ug/ L is higher than the peak EDWC value for barley of 39 ug/ L that is used in this assessment. However, it is noted that the Agency default PCA factor for cotton is 0.20. Cotton without an adjustment for PCA, or 0.87, would overestimate the EDWC. Since the value of 55 ug/ L is not adjusted for PCA (0.87 instead of 0.20), the peak EDWC of 39 ug/ L is a more accurate reflection of the highest likely acute EDWC value. Drinking Water Levels of Comparison HED uses Drinking Water Levels of Comparison (DWLOC) values as surrogate measures of exposure. As part of aggregate risk assessment, HED compares the calculated DWLOC to the EDWC( s) estimated for surface water and ground water. If the DWLOC is greater than the estimated surface and ground water concentration (i. e., if the DWLOC > EDWC) a determination of safety can be made by the Agency for aggregate exposure to a particular pesticide. If the DWLOC values are not greater than the EDWC values, the Agency may require additional data concerning water contamination. The following equations were used to calculate the acute, chronic, and short­ term DWLOC values required for disulfoton aggregate risk assessment: Acute: 6 DWLOCacute (µg/ L) = [allowable acute water exposure (mg/ kg/ day) x (kg body weight)] [consumption (L/ day) x 10 ­3 mg/ µg] where "allowable" acute water exposure (mg/ kg/ day) = [aPAD ­ acute food (mg/ kg/ day)]. Chronic: DWLOCchronic (µg/ L) = [allowable chronic water exposure (mg/ kg/ day) x (kg body weight)] [consumption (L/ day) x 10 ­3 mg/ µg] where allowable chronic water exposure (mg/ kg/ day) = [cPAD ­ (chronic food exposure (mg/ kg/ day) + chronic non­ occupational exposure (mg/ kg/ day))]. Short­ term: A short­ term DWLOC for residential applicators and a short­ term DWLOC for soil ingestion were calculated using the reciprocal MOE approach. This approach was selected as the required MOEs are identical for all MOEs in the equation (i. e., MOE = 100). 1 Aggregate MOE = 1 + 1 + 1 + 1 + 1 MOEFOOD MOEWATER MOEORAL MOEDERMAL MOEINHALATION Where the aggregate MOE is equal to the required MOE of 100; the MOEFOOD is based on the dietary exposure from average food residues (chronic dietary exposure) compared to the acute dietary NOAEL of 0.25 mg/ kg/ day; the MOEORAL is based on the calculated hand­ to­ mouth residential exposure compared to the intermediate­ term oral NOAEL of 0.03 mg/ kg/ day (based on a special six­ month oral study in the rat), the MOEDERMAL is based on the calculated high­ end dermal residential exposures compared to the short­ term dermal NOAEL of 0.5 mg/ kg/ day; and the MOEWATER is based on allowable short­ term water exposure from average drinking residues compared to the acute dietary NOAEL of 0.25 mg/ kg/ day. The MOEINHALATION is not included in this calculation as exposure via the inhalation route of exposure is considered negligible (i. e., all residue was non­ detectable, or below the level of quantitation). After solving for the term MOEWATER, allowable short­ term water exposure can be calculated as follows, where the acute dietary NOAEL is 0.25 mg/ kg/ day. MOEWATER = Short­ term oral or acute dietary NOAEL Allowable Short­ Term Water Exposure Using the allowable short­ term water exposure value, short­ term DWLOC values are calculated as follows: 7 DWLOCshort­ term (µg/ L) = [allowable short­ term water exposure (mg/ kg/ day) x (kg body weight)] [consumption (L/ day) x 10 ­3 mg/ µg] Acute Aggregate Risk The acute aggregate risk assessment for disulfoton addresses exposure from food and drinking water only. Acute dietary risk estimates are well below the Agency's level of concern ( # 100% of the aPAD) for the general U. S. population and all population subgroups. An acute DWLOC was calculated for disulfoton based on acute dietary food exposure and default body weight and water consumption figures. As shown in Table 1 below, the EDWC for ground water (1.2 µg/ L) is below the acute DWLOC for all population subgroups. The peak EDWCs for surface water range from approximately 8 µg/ L to 39 µg/ L, depending on the crop they were modeled on, and are below the acute DWLOC for the U. S. population, females 13­ 50, and seniors 55 and older. The peak EDWC for surface water (39 µg/ L; based on barley) exceeds the DWLOC for children 1­ 6 and may cause an acute aggregate risk of concern. 8 Table 1: Acute Drinking Water Levels of Comparison Acute Surface and Ground water Population Subgroup 1 PRZM/ EXAMS (µg/ L) SCIGROW (µg/ L) aPAD (mg/ kg/ d) Acute Food Exposure (mg/ kg/ d) Allowable Acute Water Exposure (mg/ kg/ d) DWLOCacute (µg/ L) U. S. Population 8 ­ 39 1.2 0. 0025 0.000176 0.00232 81 Children (1­ 6 years old) 8 ­ 39 1.2 0. 0025 0.000239 0.00226 23 Females (13­ 50 years old) 8 ­ 39 1.2 0. 0025 0.000084 0.00242 72 Seniors (55+ years old) 8 ­ 39 1.2 0. 0025 0.000184 0.00232 81 1 Population subgroups chosen were U. S. population (70 kg. body weight assumed, 2 liters water/ day), the infant/ child subgroup with the highest food exposure (10 kg. body weight assumed, 1 liter water/ day), the female subgroup with the highest food exposure (60 kg. body weight assumed, 2 liters water/ day), and the seniors 55+ subgroup (70 kg body weight assumed, 2 liters water/ day) which has a higher dietary exposure than the U. S. population. Chronic Aggregate Risk The chronic aggregate risk for disulfoton addresses exposure from food and drinking water only. Chronic residential exposures (i. e., >180 days exposure) to disulfoton are not expected and therefore are not included in this chronic aggregate assessment. Chronic dietary risk estimates are below the Agency's level of concern ( # 100% of the cPAD) for the general U. S. population and all population subgroups. A chronic DWLOC was calculated for disulfoton based on chronic dietary food exposure and default body weight and water consumption figures. As shown in Table 2 below, the chronic EDWC for ground water (1.2 µg/ L) is below the chronic DWLOC for the U. S. population, females 13­ 50 years old, and children 1­ 6 years old. Chronic aggregate risks from disulfoton residues in ground water are not expected to be of concern. The chronic EDWCs for surface water range from approximately 2 µg/ L to 17 µg/ L, depending on the crop they were modeled on. The highest EDWC of 17 µg/ L (based on potatoes) exceeds the chronic DWLOC values for all population subgroups and would result in a chronic aggregate risk of concern. The lowest EDWC of 2 µg/ L (based on cotton) would still result in a chronic aggregate risk of concern for children 1­ 6 years old, but not for the U. S. population and females 13­ 50. 9 Table 2: Chronic Drinking Water Levels of Comparison Chronic Surface and Ground water Population Subgroup 1 PRZM/ EXAMS (µg/ L) SCIGROW (µg/ L) cPAD (mg/ kg/ d) Chronic Food Exposure (mg/ kg/ d) Allowable Chronic Water Exposure (mg/ kg/ d) DWLOCchronic (µg/ L) U. S. Population 2 ­ 17 1.2 0. 00013 0.000003 0.000127 4.5 Children (1­ 6 years old) 2 ­ 17 1.2 0. 00013 0.000005 0.000125 1.3 Females (13­ 50 years old) 2 ­ 17 1.2 0. 00013 0.000003 0.000127 3.8 1 Population subgroups chosen were U. S. population (70 kg. body weight assumed, 2 liters water/ day), the infant/ child subgroup with the highest food exposure (10 kg. body weight assumed, 1 liter water/ day), and the female subgroup with the highest food exposure (60 kg. body weight assumed, 2 liters water/ day). Short­ term Aggregate Risk The short­ term aggregate risk for disulfoton addresses exposure from food uses, residential use, and drinking water contamination. Residential use is assessed for dermal exposure to adult handlers and oral exposure to children through incidental soil ingestion. Inhalation exposure is not part of the short­ term aggregate assessment as data indicate negligible exposure. Short­ term DWLOC estimates are calculated for disulfoton based on chronic dietary (food) exposure estimates and default body weight and water consumption values. Short­ term DWLOC estimates are presented in Tables 3A and 3B below. Table 3A presents the DWLOC estimates based on short­ term dermal and incidental oral exposure to the non­ Bayer supported homeowner products. Table 3B presents the DWLOC estimates based on short­ term dermal and incidental oral exposure to the Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care®. It should be noted that the short­ term DWLOC values are based on dermal exposure values from exposure scenarios that have individual MOEs greater than 100 only. Exposure scenarios with MOEs less than 100 were not included in the short­ term aggregate assessment. These scenarios include the following: (1) loading/ applying granulars with a belly grinder for flower and vegetable gardens (pre­ planting) using an application rate of 0.3 lb ai/ 1000 ft 2 (flower gardens, MOE = 1.1) and 0.069 lb ai/ 1000 ft 2 (vegetable gardens, MOE = 4.6) (3) loading/ applying granulars, using a spoon, measuring scoop, shaker can or by hand, to flower gardens and ornamental shrubs/ small trees using an application rate of 0.3 lb ai/ 1000 10 ft 2 (flower gardens, MOE = 34) and 0.01 lb ai/ four foot shrub (shrubs/ small trees, MOE = 41). The EDWC for ground water (1.2 µg/ L) is below the short­ term DWLOC for all population subgroups. EDWCs in surface water range from approximately 2 µg/ L (based on cotton) to 17 µg/ L (based on potatoes, east of the Rockies). The highest EDWC of 17 µg/ L would slightly exceed the short­ term DWLOC for children 1­ 6 years old, when considering the use of non­ Bayer supported products. Short­ term aggregate exposure for children 1­ 6 years old may be of concern for non­ Bayer supported products. Short­ term aggregate exposure is not of concern for any population subgroup for the Bayer­ supported 1% granular formulation. 11 Table 3a: Short­ term Drinking Water Levels of Comparison for the Non­ Bayer Supported Products Population Subgroup 1 PRZM/ EXAMS (µg/ L) SCI GROW (µg/ L) High­ end Dermal Exposure 2 (mg/ kg/ d) High­ end Inhalation Exposure (mg/ kg/ d) Hand­ to­ mouth Oral Exposure (mg/ kg/ d) 3 Chronic Food Exposure (mg/ kg/ d) Allowable Short­ Term Water Exposure (mg/ kg/ d) DWLOC short term (µg/ L) U. S. Population 2 ­ 17 1.2 0. 0034 negligible n/ a 0. 000003 0.000797 28 Children (1­ 6 years old) 2 ­ 17 1.2 n/ a negligible 0.00013 0.000005 0.00141 14 Females (13­ 50 years old) 2 ­ 17 1.2 0. 0034 negligible n/ a 0. 000003 0.000797 24 1 Population subgroups chosen were U. S. population (70 kg. body weight assumed, 2 liters water/ day), the infant/ child subgroup with the highest food exposure (10 kg. body weight assumed, 1 liter water/ day), and the female subgroup with the highest food exposure (60 kg. body weight assumed, 2 liters water/ day). 2 High­ end dermal exposure value of 0.0034 mg/ kg/ d is based on the "loading/ applying granulars using a spoon, measuring scoop, shaker can, or by hand" to vegetable gardens scenario. 3 Hand­ to­ mouth oral exposure value of 0.00013 mg/ kg/ d is based on incidental soil ingestion for flowerbeds. 12 Table 3b: Short­ term Drinking Water Levels of Comparison for the Bayer­ Supported 1% Granular Formulation Population Subgroup 1 PRZM/ EXAMS (µg/ L) SCI GROW (µg/ L) High­ end Dermal Exposure 2 (mg/ kg/ d) High­ end Inhalation Exposure (mg/ kg/ d) Hand­ to­ mouth Oral Exposure 3 (mg/ kg/ d) Chronic Food Exposure (mg/ kg/ d) Allowable Short­ Term Water Exposure (mg/ kg/ d) DWLOC short term (µg/ L) U. S. Population 2 ­ 17 1.2 0. 00033 negligible n/ a 0. 000003 0.002332 82 Children (1­ 6 years old) 2 ­ 17 1.2 n/ a negligible 0.0000917 0.000005 0.00173 17 Females (13­ 50 years old) 2 ­ 17 1.2 0. 00033 negligible n/ a 0. 000003 0.002332 70 1 Population subgroups chosen were U. S. population (70 kg. body weight assumed, 2 liters water/ day), the infant/ child subgroup with the highest food exposure (10 kg. body weight assumed, 1 liter water/ day), and the female subgroup with the highest food exposure (60 kg. body weight assumed, 2 liters water/ day). 2 High­ end dermal exposure value of 0.00033 mg/ kg/ d is based on the "loading/ applying Bayer Advanced Garden 2­ in­ 1 Systemic Rose and Flower Care® Disulfoton 1% granulars using a measuring cup/ lid" to shrubs scenario. 3 Hand­ to­ mouth oral exposure value of 0.0000917 mg/ kg/ d is based on incidental soil ingestion for flowerbeds. 13 Conclusion The Agency's aggregate risk assessment for disulfoton is based on exposure estimates for food and residential uses and provides a screening level assessment of modeled estimates for drinking water contamination . Dietary risk estimates are based on a refined assessment that incorporates percent crop treated data, monitoring data, and processing data. It is unlikely that this dietary assessment can be refined to any significant degree. Residential risk estimates are based, in part, on a registrant­ submitted homeowner garden study that was conducted specifically for the Bayer 1% granular formulation. It is also unlikely that the residential assessment (for the 1% granular product) can be refined to any significant degree. Further refinements to the residential assessment for the non­ Bayer supported products may be possible through exposure studies or improved use information. However, the drinking water assessment is based on limited monitoring data and modeled estimates, and is not considered a refined estimate that represents actual disulfoton contamination in finished tapwater. The Agency has drawn the following conclusions from its aggregate risk analysis for disulfoton: ° The EDWC estimates for disulfoton residues in surface water exceed the Agency's estimated acute DWLOC value for children 1­ 6 years old, when the highest peak EDWC value from the use on barley is considered. ° When the highest annual EDWC value from the use on potatoes (east of the Rockies) is considered, the chronic DWLOC value is exceeded for all population subgroups. When the lowest annual EDWC value from the use on cotton is considered, the chronic DWLOC value is exceeded for children 1­ 6 years old only. ° When the highest EDWC value from the use of potatoes (east of the Rockies) is considered, the short­ term DWLOC value is exceeded for children 1­ 6 years old when considering the non­ Bayer supported products. The lowest EDWC value from the use on cotton does not exceed the short­ term DWLOC value for any population subgroup. Based on all available information, the Agency is unable to conclude with reasonable certainty that residues of disulfoton in drinking water, when considered along with exposures from food and residential uses, will not result in an aggregate risk of concern. However, since a range of EDWC values were used in this assessment, and the exceedance of the DWLOC value often resulted from the use of the highest EDWC value, any deletion of use or reduction in application rates by the registrant may improve the findings of this aggregate assessment.

epa

2024-06-07T20:31:41.642098

regulations

EPA-HQ-OPP-2002-0055-0009

Supporting & Related Material

Memorandum Amended 8/ 26/ 00 from 01/ 13/ 00 from 10/ 07/ 99 from 8/ 26/ 99 To: Christina Scheltema, Chemical Review Manager Special Review & Reregistration Division 7508W From: EFED Disulfoton Team Henry Craven, Biologist John Jordan, Microbiologist James Wolf, Soil Scientist Mary Frankenberry, Statistician Thru: Arnet Jones, Chief Environmental Risk Branch III Environmental Fate & Effects Division 7507C Subject: Reregistration Eligibility Document for Disulfoton ( D237134) Attached to this memorandum is the revised EFED RED chapter for disulfoton. EFED has reviewed the public comments and has modified the chapter in response to the comments. This transmittal memo summarizes EFED s findings and recommendations for potential mitigation, monitoring and labeling. The risk assessment was performed by evaluating use information listed in both the BEAD LUIS report for disulfoton as well as information supplied by Bayer Corporation, the major registrant for disulfoton products, and current labels ( EPA Reg. No. 3125­ 172; 3125­ 307) . Background Disulfoton is an organophosphate insecticide/ acaricide used on a variety of terrestrial food crops, terrestrial feed crops, and terrestrial nonfood crops. Disulfoton is formulated as 15% granules, 8% emulsifiable systemic, 95% cotton seed treatment, systemic granules ( 1, 2, 5, 10% ) , and 68% concentrate for formulating garden products. Directions regarding application intervals, number of applications and total application per year or crop cycle are not always specified by the label. 1 Environmental Fate Summary Parent disulfoton has low to intermediate potential mobility ( Kocs 386­ 888) and is neither persistent ( average ( half­ life) T1/ 2 is 4.8 days) nor volatile. Disulfoton photo­ degrades within 2.4 days on soil and in water under natural sunlight the T1/ 2 is 4 days. Disulfoton is essentially stable to hydrolysis at 20 E C at pH 5, 7, and 9, but hydrolyzes much more rapidly at 40 E C. Soil applied disulfoton will be degraded rapidly oxidized by chemical reaction and microbial metabolism to its corresponding D. sulfoxide and D. sulfone. Aerobic soil metabolism data indicated that the sulfoxide ( T1/ 2 > 17days) and sulfone ( T1/ 2 > 120 days) degradates of disulfoton are more persistent and mobile then parent disulfoton. In a recently submitted leaching study, nine additional metabolism products were identified, at least three may have human toxicity issues. Field dissipation information also indicates that the degradates may persist longer in the environment, D. sulfoxide has a half­ life of 8 to 10 weeks and D. sulfone remained fairly stable over a 294­ day period. There is insufficient environmental fate information on the degradates to fully characterize their fate and transport. The half­ life for total disulfoton residues was greater than 170 days. Open literature suggests that D. sulfoxide can be reduced to back to disulfoton. Information is not available to assess the significance of the reduction of D. sulfoxide. Aerobic and anaerobic aquatic metabolism studies which could provide valid model inputs for the degradates disulfoton sulfone and disulfoton sulfoxide have not been submitted. Although the registrant provided the Agency with additional information concerning the fate of disulfoton residues in water under controlled artificial conditions ( MRID 43568501 and LaCorte et al. , 1995) , this information is limited and should not be used for model inputs. Specifically, these studies provide information concerning the combined effects of hydrolysis, photolysis, and metabolism, with photodegradation contributing significantly to the dissipation. Water Resources Summary The Water Resources Assessment considered the potential of disulfoton and its degradates, D. sulfoxide and D. sulfone, to contaminate ground water, surface water, and drinking water from labeled uses. The assessment included a TIER II ( PRZM/ EXAMS) analysis which estimates environmental concentrations ( EECs) in surface water for disulfoton parent and for total disulfoton residues, TDR ( sum of disulfoton, sulfoxide, and sulfone) , applied at the maximum label rate and number of applications to barley, cotton, potatoes, spring wheat, and tobacco. The OPP standard farm pond was used for ecological exposure assessment and the Index Reservoir and Percent Crop Area ( PCA) were factored into the drinking water assessment. These crops represent major uses and generally reflect the highest use rates and total amounts. The potential for disulfoton parent residues ( and TDR) to contaminate ground water was assessed using the EFED ground­ water concentration screening model ( SCI­ GROW) and monitoring data available in EFED s Pesticides in Ground Water Data Base ( PGWDB) , EPA' s STORET data base, and in the USGS National Water Quality Assessment Program ( NAWQA) . Surface­ water monitoring data sources available in the USGS NAWQA program and the EPA s STORET data base were also considered. Disulfoton is likely to be found in runoff water and sediment from treated and cultivated fields. 2 The fate of disulfoton and its degradates once in surface water and sediments, and the likely concentrations therein, cannot be modeled with a high degree of certainty since data are not available for the aerobic and anaerobic aquatic degradation rates. Estimates of disulfoton concentrations in ground water did not consider the anaerobic soil metabolism, as studies have been submitted by the registrant, but have not reviewed by EFED. The anaerobic soil metabolism rate for disulfoton appears to be slower than the aerobic soil metabolism rate. For this assessment, the aerobic aquatic metabolism rate, required by EXAMS, was estimated by using EFED' s recommended guidance to estimate an aerobic aquatic metabolism rate from aerobic soil metabolism rates ( e. g. , multiply the soil aerobic metabolism rate used in PRZM by 0.5 ( doubles the half­ life) ) . In lieu of actual data on persistence of disulfoton in an aquatic environment, the assumed aquatic metabolism rate for EXAMS will reduce the estimated concentrations, but not the uncertainty. Considering the relatively rapid rate of microbial degradation in the soil and aquatic photolysis in surface water, parent disulfoton may degrade fairly rapidly, whereas the degradates are more persistent and may not degrade as rapidly in water. As noted above the registrant has submitted additional information suggesting a fairly rapid degradation of disulfoton and D. sulfoxide and D. sulfone in natural water under artificial conditions. Sorption data ( reflection of mobility, e. g. , Kds) are also not available for the sulfoxide and sulfone degradates ( and other degradates) , were considered to be equal to the parent in the modeling. Typically, however, the D. sulfoxide and D. sulfone degradates are more mobile than the parent. The peak concentrations of parent disulfoton appear capable of being quite high, especially when high, foliar application rates are used and coincide with a rainfall event. Limited monitoring confirms this ( VA, CO) . A large degree of latitude available in the disulfoton labels also allows for wide variation in possible application rates, total amounts of disulfoton applied, application methods, and intervals between applications. Lower application rates would result in lower estimated concentrations ( EECs) . Additionally, considerable uncertainty exists because the percent crop area or PCA value was not known, thus, the default value was applied. The low concentrations typically reported in available ground water and surface water monitoring data of parent disulfoton tends to confirm fairly rapid degradation and low mobility, but do not preclude potentially high peak values ( few reported high values) . Although no assessment can be made for degradates due to lack of data, limited data suggests that the degradates are more persistent than disulfoton, suggesting their presence in water for a longer period of time than the parent Surface Water Modeling: In the Tier II PRZM/ EXAMS assessment, the overall estimate of the multiple year mean concentrations of disulfoton in a farm pond over multiple years simulated ranged from 0.21 µ g/ L for two applications at the maximum rate ( 1.00 lb ai/ A) to barley in Virginia to 1.14 µ g/ L for potatoes in Maine with three applications at the maximum application rate ( 1.00 lb ai/ A) . Maximum, or peak, estimated concentrations of 26.75 µ g/ L occurred for one 4.00 lb. ai/ ac application of disulfoton to tobacco. For the other scenarios, the maximum concentrations ranged from 7.14 to 18.46 µ g/ L. 3 The estimated drinking water concentrations using the Index Reservoir ( IR) and PCA ( PCA) concepts for the same scenarios were evaluated. The long term mean of the parent disulfoton concentration in the Index Reservoir and by PCA ranged from 0.23 to 1.31 µ g/ L for cotton and tobacco, respectively. The 1­ in­ 10 year estimated annual mean concentration ranged from 0.43 to 2.77 µ g/ L for cotton and tobacco, respectively. The peak 1­ in­ 10 year estimated drinking water concentration for parent disulfoton ranged from 7.13 to 44.20 µ g/ L. The Tier II modeling results from PRZM/ EXAMS fall within the range of concentrations for surface water reported in the STORET database ( 0.0 to 100 µ g/ L, 96 percent of 8137 samples were reported as less than 16 µ g/ L) , a Virginia monitoring study ( 0.37 to 6.11 µ g/ L) and NAWQA ( 0.010 to 0.060 µ g/ L) . But because some of the data in STORET have a high degree of uncertainty because many samples were only listed as actual value is known to less than given value , the maximum concentration of samples was not always known ( see Appendix III) . The modeled concentration estimates are generally greater than those seen in the monitoring data. The modeling results therefore cannot be confirmed by the monitoring data. Because the degradates of disulfoton ( including oxygen analogs) : sulfoxide and sulfone are also toxic, the EECs of the total disulfoton residue ( TDR) in a farm pond was also considered. The overall estimated of the multiple year mean concentrations of TDR in a farm pond over multiple years simulated ranged from 3.89 µ g/ L for two applications at the maximum rate ( 1.00 lb ai/ A) to barley in Virginia to 9.32 µ g/ L for tobacco in Georgia with one application at the maximum application rate ( 4.00 lb ai/ A) . Maximum, or peak, estimated TDR concentrations of 58.47 µ g/ L occurred for one 4.00 lb. ai/ ac application of disulfoton to tobacco. For the other scenarios, the maximum TDR concentrations ranged from 15.32 to 52.93 µ g/ L. There are no monitoring data to evaluate these concentration estimates from PRZM/ EXAMS modeling. Total disulfoton residues using the IR and PC concepts were also considered for drinking water. The long term mean of the total disulfoton residues ( TDR) in the Index Reservoir and by PCA ranged from 2.55 to 10.42 µ g/ L for cotton and potatoes, respectively. The 1­ in­ 10 year estimated annual mean TDR concentrations in the IR ranged from 5.10 to 16.72 µ g/ L for cotton and potatoes, respectively. The peak 1­ in­ 10 year estimated TDR concentrations in the IR ranged from 20.83 to 104.92 µ g/ L. There are no monitoring data to evaluate these concentration estimates from PRZM/ EXAMS modeling. Uncertainty surrounds these estimates because the sites selected for modeling represent sites though to be representative of vulnerable sites. Additionally, the IR was generic ( to each scenario) and data to fully understand of the fate of disulfoton and disulfoton residues is available. Evidence suggests that the concentrations will not be as high as suggest by the modeled estimates. The PCA values have been estimated by OPP for spring wheat ( 0.56) and cotton ( 0.20) . The default for value for all agricultural land of 0.87 was used for the barley, potatoes, and tobacco scenarios. Better estimates of the PCA for these crops would reduce the uncertainty associated with the estimated drinking water concentrations. 4 Ground Water Modeling: The maximum disulfoton concentration predicted in ground water by the SCI­ GROW model ( using the maximum rate 4 lb. a. i. / ac and 2 applications ­ potatoes) was 0.05 µ g/ L. The maximum total disulfoton residue concentration predicted in ground water by the SCI­ GROW model for the same scenario is 3.19 µ g/ L. The SCI­ GROW model represents a " vulnerable site" , but not necessarily the most vulnerable, treated ( here) with the maximum rate and number of disulfoton applications, while assuming conservative environmental properties ( 90 percent upper confidence bound on the mean aerobic soil half­ life and an average Koc value) . Monitoring data has reported a few disulfoton concentrations higher than those estimated by SCI­ GROW. Disulfoton Monitoring Data: Based upon the fate properties of disulfoton parent, which is not very persistent, or mobile you would not expect to observe disulfoton in ground water. The Pesticides in Ground Water Data Base ( USEPA, 1992) summarizes the results of a number of ground­ water monitoring studies conducted which included disulfoton ( and rarely the disulfoton degradates D. sulfone and D. sulfoxide) . Monitoring, with no detections ( limits of detections ranged from 0.01 to 6.0 µ g/ L) , has occurred in the following states ( number of wells) : AL ( 10) , CA ( 974) , GA ( 76) , HI ( 5) , IN ( 161) , ME ( 71) , MS ( 120) , MN ( 754) , OK ( 1) , OR ( 70) , and TX ( 188) . The range of detection limits, especially the high ones ( e. g. , 6 µ g/ L) reduce the certainty of these data. Disulfoton residues were detected in ground water in Virginia and Wisconsin. In Virginia, 6 of the 12 wells ( 8 monitoring wells) sampled monthly from June 1986 through December 1990 had disulfoton detections ranging from 0.04 to 2.87 µ g/ L. In Wisconsin, 14 of 26 wells ( municipal, community, and home wells) sampled, during May and June 1982, had disulfoton residues ranging from 4.0 to 100.0 µ g/ L, with a mean of concentration of 38.4 µ g/ L. Although the Wisconsin study has received some criticism, particularly over QA/ QC issues, EFED believes that this study needs to be considered in the risk assessment. The Wisconsin study was conducted in the Central Sand Plain of Wisconsin which is extremely vulnerable to ground­ water contamination. Detections of other pesticides in this area have often tended to be orders of magnitude greater than those seen other areas. One hundred twenty wells were analyzed in MS for disulfoton degradates sulfone and sulfoxide and 188 wells were analyzed in TX for sulfone. Limits of detection were 3.80 and 1.90 µ g/ L for the sulfone and sulfoxide degrade, respectively, in MS. There were no degradates reported in these samples. In a more recent ground­ water monitoring study conducted in North Carolina, there were no detections of disulfoton, disulfoton sulfoxide, and disulfoton sulfone. Efforts were made in the study to place the wells in vulnerable areas where the pesticide use was known, so that the pesticide analyzed for would reflect the use history around the well. Limitations of the study include that sites were sampled only twice and the limits of detections were high ( e. g. , > 1.0 µ g/ L) for some of disulfoton analytes ( NCIWG, 1997; DP Barcode 267486) . Surface­ water samples were also collected ( same Virginia study as noted above) in study to evaluate the effectiveness of Best Management Practices ( BMP) in a Virginia watershed. Approximately half of the watershed is in agriculture and the other half is forested. Parent 5 disulfoton was detected in several surface­ water samples with concentrations ranging from 0.037 to 6.11 µ g/ L. These levels are within the same order of magnitude of the estimated environmental concentrations ( EECs) obtained from the PRZM/ EXAMS models for parent disulfoton which range from 0.21 to 1.14 µ g/ L for annual mean daily concentrations and 7.14 to 26.75 µ g/ L for peak daily values. Disulfoton residues have been detected in surface water at a low frequency in the USGS NAWQA study. The percentage of detections with disulfoton concentrations > 0.01 µ g/ L for all samples, agricultural streams, urban streams were 0.27% , 0.20, and 0.61% , respectively. The corresponding maximum concentrations were 0.060, 0.035, and 0.037 µ g/ L. Disulfoton has not been detected in ground water in the NAWQA study. Although pesticide usage data is collected for the different NAWQA study units, the studies are not targeted, specifically for disulfoton. Limitations for the monitoring studies include the use of different limits of detection between studies, lack of information concerning disulfoton use around sampling sites, and lack of data concerning the hydro geology of the study sites. About 50 percent of the well samples reported in STORET had low levels ( < 1 µ g/ L) of disulfoton residues. However, there were indications of some high concentrations ( the other 50% were reported as < 250 µ g/ L) , which may be a reflection of how the data were reported as the disulfoton concentrations in the monitoring were not always known. This is because the detection limit was extremely high or not specified, and/ or the limit of quantification was not stated or extremely high. Disulfoton concentrations were simply given as less than a value. Therefore, considerable uncertainty exists with respect to the STORET monitoring data. The spatial and temporal relationship between disulfoton use, rainfall/ runoff events and the location and time of sampling frequently cannot be adequately determined. Toxicity Summary The available acute toxicity data on the TGAI indicate that disulfoton is: highly to very highly toxic to birds on an acute oral basis ( LD50 = 3.2 to 39 mg/ kg) ; moderately to highly toxic to birds on a dietary basis ( LC50 = 333 to 622 ppm) ; very highly toxic to mammals on an acute oral basis ( LD50 = 1.9 to 15 mg/ kg) ; moderately toxic to bees ( LD50 = 4.1 µ g/ bee) ; very highly toxic to moderately toxic to freshwater fish ( LC50 = 39 to 7,200 ppb) ; very highly toxic to freshwater invertebrates ( LC50 = 3.9 to 52 ppb) ; highly toxic to marine/ estuarine fish ( LC50 = 520 ppb) and very highly toxic to marine/ estuarine invertebrates ( LC50 or EC50 = 15 to 900 ppb) . Acute toxicity for the sulfone degradate indicate that it is highly toxic to birds on an acute oral basis ( LD50 = 18 mg/ kg) , moderately toxic to birds on a dietary basis ( LC50 = 558 to 622 ppm) , highly toxic to mammals on an acute oral basis ( LD50 = 11.24 mg/ kg) , highly toxic to bees ( LD50 = 0.96 F g/ bee) , highly to moderately toxic to freshwater fish ( LC50 = 112 to > 9,200 ppb) , very highly toxic to freshwater invertebrates ( LC50 = 35.2 ppb) , and moderately toxic to marine/ estuarine fish ( LC50 = 1,060 ppb) . The sulfoxide metabolite is very highly toxic to birds on an acute oral basis ( LD50 = 9.2 mg/ kg) ; moderately to highly toxic to birds on a dietary basis ( LC50 = 456 to 823 ppm) ; moderately toxic 6 to bees ( LD50 = 1.11 µ g/ bee) ; highly to slightly toxic to freshwater fish ( LC50 = 188 to 60,300 ppb) ; very highly toxic to freshwater invertebrates ( LC50 = 64 ppb) ; and slightly toxic to marine/ estuarine fish ( LC50 = 11,300 ppb) . Chronic toxicity studies on disulfoton established the following NOAEC values: 37 ppm for birds, 0.8 ppm for small mammals, 220 ppb for freshwater fish ( 4.6 ppb for bluegill sunfish, using the factor of chronic to acute values for the rainbow trout) , 0.037 ppb for freshwater invertebrates, 16.2 ppb for marine/ estuarine fish early life­ stage, 0.96 ppb for marine/ estuarine fish for life­ cycle, and 2.35 ppb for marine/ estuarine invertebrates. There are chronic invertebrate studies on the 2 major degradates­ ­ sulfone ( NOAEC 0.14 ppb) and sulfoxide ( NOAEC 1.53 ppb) . Risk Assessment Summary Risk Characterization A. Characterization of the Fate and Transport of Disulfoton I. Water Exposure ( a) Surface Water Disulfoton is likely to be found in runoff water and sediment from treated and cultivated fields. However, the fate of disulfoton and its degradates once in surface water and sediments, and the likely concentrations therein, cannot be modeled with a high degree of certainty since data are not available for the aerobic and anaerobic aquatic degradation rates. Surface water concentrations of disulfoton and total disulfoton residues were estimated by using PRZM3 and EXAMS models using several different scenarios ( barley, cotton, potato, tobacco, and spring wheat) . The large degree of latitude available in the disulfoton labels also allows for a wide range of possible application rates, total amounts, application methods, and intervals between applications. Considering the relatively rapid rate of microbial degradation in the soil ( < 20 day aerobic soil metabolism half­ life) and direct aquatic photolysis, disulfoton parent may degrade fairly rapidly in surface water. However, peak concentrations of disulfoton in the farm pond appear capable of being quite high, with 1­ year­ in 10 peak surface water concentrations of 7.14 to 26.75 F g/ L and 90­ day concentrations of 1.73 to 6.87 µ g/ L for the parent compound. The mean EECs of the annual means of disulfoton ranged from 0.21 to 1.14 µ g/ L. Although there is a lack of some environmental fate data for the degradates, the assessment suggests that the degradates will reach higher concentrations than the parent because they are more persistent and probably more mobile. The estimated peak concentrations for the total disulfoton residues in the farm pond ranged from 15.43 to 58.48 µ g/ L, 90 day average ranged from 12.20 to 35.30 µ g/ L, and the mean of the annual means ranged from 3.89 to 9.32 µ g/ L. Water samples collected at the site of a fish kill in Colorado contained D. sulfoxide at levels of 29.5­ 48.7 µ g/ L, and D. sulfone at 0.0199­ 0.214 µ g/ L. The aerobic soil metabolism studies show that the maximum sulfoxide residues are about 58 percent of total radioactive material, thus, the sulfoxide concentrations suggest that parent 7 disulfoton concentrations could range from 50.8 to 83.9 µ g/ L. The ratio of the disulfoton sulfoxide concentration to the average maximum disulfoton concentration was higher ( 74% ) in the microcosm study ( MRID # 4356501) than in the soil residues ( 58% ) . The estimated drinking water concentrations ( EDWC) for parent disulfoton and total disulfoton residues were also determined using the IR and PCA concepts. The peak concentrations of disulfoton in IR appear capable of being quite high, with 1­ year­ in 10 peak surface water concentrations of 7.13 to 44.20 F g/ L and annual mean concentrations of 0.43 to 2.77 µ g/ L for the parent compound. The mean EECs of the annual means of disulfoton ranged from 0.23 to 1.31 µ g/ L. Although there is a lack of some environmental fate data for the degradates, the assessment suggests that the degradates will reach higher concentrations than the parent because they are more persistent and probably more mobile. The estimated 1­ in­ 10 year peak concentrations for the total disulfoton residues in the IR ranged from 20.83 to 104.92 µ g/ L and annual mean ranged from 5.10 to 16.25 µ g/ L, and the mean of the annual means ranged from 2.55 to 10.42 µ g/ L. These values will be highly effected by the value selected for PCA. The PCA values have been estimated by OPP for spring wheat ( 0.56) and cotton ( 0.20) . The default for value for all agricultural land of 0.87 was used for the barley, potatoes, and tobacco scenarios. Better estimates of the PCA for these crops would reduce the uncertainty associated with the estimated drinking water concentrations. Surface­ water samples were collected in a study to evaluate the effectiveness of Best Management Practices ( BMP) in a Virginia watershed. Approximately half of the watershed is in agriculture and the other half is forested. The detections of parent disulfoton in surface­ water samples ranged from 0.037 to 6.11 µ g/ L and fell within an order of magnitude with the estimated environmental concentrations ( EECs) obtained from the PRZM/ EXAMS models. Surface­ water monitoring by the USGS in the NAWQA ( USGS, 1998) project found relatively few detections of disulfoton in surface water with a maximum concentration of 0.060 µ g/ L. As noted above disulfoton degradates were reported in surface water, when a rainfall event occurred following application to wheat, where fish kills occurred; pesticide residue concentrations ranged from 29.5 to 48.7 µ g/ L for D. sulfoxide and 0.02 to 0.214 µ g/ L ( Incident Report No. I001167­ 001) . A search of the EPA s STORET ( 10/ 16/ 97) data base resulted in the identification of disulfoton residues at a number of locations. Often the values ranged from 0.01 to 100.0 F g/ L with most of the values reported as actual value is less than this value. Thus, , when a value of 100.00 µ g/ L is reported, it is not known how much less than 100.0 F g/ A the actual value is known to be less. Thus there is considerable uncertainty surrounding some of the data in STORET. ( b) Ground Water The SCI­ GROW ( Screening Concentration in Ground Water) screening model developed in EFED was used to estimate disulfoton concentrations in ground water ( Barrett, 1997) . SCI ­ GROW represents a " vulnerable site" , but not necessarily the most vulnerable conditions, treated 8 ( here) with the maximum rate and number of disulfoton applications, while assuming conservative environmental properties ( 90 percent upper confidence bound on the mean aerobic soil half­ life of 6.12 days and an average Koc value of 551 mL/ g) . The maximum disulfoton concentration predicted in ground water by the SCI­ GROW model ( using the maximum rate 4 lb. a. i. / ac and 2 applications ­ potatoes) was 0.05 µ g/ L. The maximum total disulfoton residue concentration predicted in ground water by the SCI­ GROW model for the same scenario is 3.19 µ g/ L ( except 90 percent upper bound on mean half­ life of total residues is 259.6 days) . Ground water monitoring data generally confirms fairly rapid degradation and low mobility, because of the relatively low levels and frequency of detections of parent disulfoton in ground water. There were no ground­ water detections of parent disulfoton in the USGS NAWQA ( USGS, 1998) with a limit of detections of 0.01 or 0.05 µ g/ L, depending upon method. . Most of the studies recorded in the PGWDB ( USEPA, 1992) also reported no disulfoton detections. Disulfoton residues ranging from 0.04 to 100.00 µ g/ L were reported for studies conducted in Virginia ( 0.04 to 2.87 µ g/ L) and Wisconsin ( 4.00 to 100.00 µ g/ L) . Of specific interest are areas where the concentrations of parent disulfoton reported in the studies ( VA and WI) exceeded the estimate of 0.05 µ g/ L obtained from EFED' s SCI­ GROW ( ground­ water screening model) model. It should be noted that the Wisconsin data received some criticism which influences the certainty of these detections, no such criticisms or limitations exist for the Virginia study. The major issues, concerning the Wisconsin study ( Central Sands) were that the study may not have followed QA/ QC on sampling and the failure of follow­ up sampling to detect disulfoton residues in ground water as suggested by Holden ( 1986) , have been considered by EFED in the ground­ water quality assessment. The Central Sands of Wisconsin are known to be highly vulnerable to ground­ water contamination. There are regions within the United States that have conditions that are highly vulnerable to ground water contamination and regularly have pesticides detected in ground water which far exceeds values seen elsewhere. Several of these areas are well documented, e. g. , Long Island, Suffolk County, NY and Central Sands in WI. Although, some questions have been levied against the disulfoton detections in Wisconsin, the occurrence of disulfoton at the levels reported cannot be ruled out. There were no detections of disulfoton, disulfoton sulfoxide, and disulfoton in the ground­ water monitoring study conducted in North Carolina. Efforts were made to place the wells in vulnerable areas where the pesticide use was known, so that the pesticide analyzed for would reflect the use history around the well. Seven Christmas tree, one wheat, and two tobacco growing areas were sampled for disulfoton. Limitations of the study include that sites were sampled only twice and the limits of detections were high ( e. g. , > 1.0 µ g/ L) for some of disulfoton analytes. Uncertainties associated with the study include whether two samples from eight wells are adequate to represent the ground­ water concentrations of disulfoton residues, did DRASTIC correctly identify a site' s vulnerability, and were the wells placed down­ gradient of the use areas. The SCI­ GROW model represents a " vulnerable site" , but not necessarily the most vulnerable. 9 Several things should be considered. First, the Virginia and Wisconsin monitoring studies were probably conducted in areas vulnerable to ground­ water contamination. The level of certainty with respect to vulnerability is probably greater for Wisconsin ( relatively less uncertainty) than for Virginia ( relatively more uncertainty ) . The occurrence of preferential flow and transport processes has been also noted in Wisconsin ( and is also possible in Virginia) and may ( speculation) have contributed to the " high" concentrations ( especially in WI) when the initial sampling occurred, but not necessarily in the follow­ up sampling) . The knowledge concerning the disulfoton use in areas in association with the wells is not well known ( high uncertainty) . Some notable limitations of modeling and monitoring are presented elsewhere in this document ( c) Drinking Water The Agency recommends that the 1­ out­ of­ 10­ year peak values be used the acute surface drinking water level for parent disulfoton, and for chronic levels use either the 90­ day and annual average. The maximum values are: 44.20, 2.77, and 1.31 µ g/ L or the peak, 90­ day mean, and long term mean, respectively. For the total disulfoton residues the peak, 90­ day mean, and long term mean are 104.92, 53.47, and 10.42 µ g/ L. The EDWCs for both parent disulfoton and TDR exceed the DWLOC values estimated by the Agency. The EDWCs values for the parent disulfoton have less uncertainty than the total residue, because there is more certainty surrounding the " estimated" aerobic aquatic metabolism half­ life for the estimated aerobic aquatic half­ life for the total disulfoton residues. It is recommended that the Virginia data be considered in the " quantitative" drinking water assessment for ground water exposure. The Wisconsin data should be noted and addressed more qualitatively. Highly vulnerable areas, such as the Central Sand Plain, do not represent the entire use area and can probably be better mitigated or managed a local or state level. Specifically, it is recommended that the 2.87 µ g/ L be used for acute and chronic exposure from ground water. Based upon the fate properties of disulfoton, the sulfoxide and sulfone degradates ( more persistent and probably more mobile) have a greater probability of being found in ground water. It is likely that a ground water study ( ies) may be required to better assess the potential exposure from the degradates ( and also parent) . B. Characterization of risk to nontarget species from Disulfoton Birds: Acute risk to birds is predicted especially for use patterns involving the 15 G formulation. All modeled application rates and methods for the 15 G formulation exceed the acute risk level of concern for birds, regardless of size. Robins were reported to have been killed following the application of a disulfoton granular product to a tree nursery. Carcasses were found during terrestrial field testing of disulfoton on potatoes, confirming the presumption of acute risk to birds. Since disulfoton is a systemic pesticide, the granular formulations can result in exposure through food items due to uptake by the plant tissues in addition to direct exposure to any unincorporated granules. Foliar applications of liquid formulations present the greatest risk to herbivorous birds. Based on 10 the results of field studies, the residue levels on sampled invertebrates are well below those predicted by EFED' s models, consequently insectivores did not appear to be at risk. However, there is field evidence suggesting that some species are extremely sensitive to disulfoton such that even low concentrations caused mortality. The Swainson s hawk kill appears to be the result of consuming grasshoppers. The hawks crop contents were analyzed and contained residues around 8 ppm. Finally, live blue jays collected 6 to 7 hrs after a pecan orchard was sprayed at 0.72 lbs ai/ A had brain cholinesterase inhibition from 32 to 72% ( White et al. 1990) . Although it is unknown whether these birds would eventually die, Ludke et al. 1975 suggest that inhibition > 50% in carcasses is evidence that death was caused by some chemical agent. Furthermore, it should be recognized that these birds were not only feeding on contaminated food, but also were impacted by dermal and inhalation exposure. Ground applications of liquid formulations to soil, even at 4.0 lb ai/ A would not be expected to cause mortality to birds. Field studies have demonstrated that residue concentration within food items ­ ­ vegetation, invertebrates and seeds ­ ­ in or on the edge of fields are well below those used in screening level assessments and empirically derived from aerial applications. However, in light of the points made in the previous paragraph, some mortality is possible given the possible multiple routes of exposure and hypersensitivity of some species. Chronic risk to herbivorous birds are predicted from exposure to disulfoton when assuming birds are exposed to peak residues for a short period of time or average Fletcher maximum residues for longer periods. Based on reduced hatchling weight, the NOAEC is 37; both for bobwhite quail and mallard duck. Foliar applications and aerially applied soil sprays are estimated to result in 30 day average residues ( based on maximum Fletcher values) on vegetation exceeding the avian chronic level of concern for application rates equal or greater than a single application of 1 lb ai/ A. A residue monitoring study for Di­ syston 8E in potatoes showed the peak residues on vegetation was 105 ppm after the initial application and 152 ppm following a second application 6 to 10 days later. In the same study, the means of the 3 applications for vegetation in and adjacent to fields were 41 and 14 ppm respectively. The upper bound 95% mean for the vegetation adjacent to the fields was 71 ppm. Therefore even empirically derived residues suggest that the chronic LOC is exceeded on foliage, but not invertebrates for a short time following aerial applications. It is anticipated that since the sulfone and sulfoxide degradates of disulfoton were similar in acute toxicity to parent disulfoton they would have similar chronic NOAECs. These degradates extend the time that total disulfoton residues are available for consumption. Since many of the applications of disulfoton occur in the spring, overlapping the breeding season for most bird species, there is the potential for significant reproductive impacts. Mammals: Acute risk to mammals is expected for use patterns involving the 15 G formulation. All modeled application rates and methods exceed the acute risk level of concern for mammals, regardless of the mammals size. . Small mammal carcasses were found during terrestrial field testing of disulfoton on potatoes, confirming the presumption of acute risk to mammals. Since disulfoton is a systemic pesticide, the granular formulations can result in exposure through food items due to uptake by the plant tissues in addition to direct exposure to any unincorporated granules. 11 Applications of the liquid formulations especially by air can result in mammals being exposed to multiple routes of exposure ­ ­ dermal, inhalation, drinking contaminated water as well as ingestion of contaminated food items. The persistent sulfone and sulfoxide degradates are also toxic to mammals, thereby increasing the potential risk from the application of disulfoton. The registrant has suggested that mammals as well as birds can consume an equivalent of 2 to 3 LD50' s as part of their diet and not be adversely effected. Although this may be true for a population of laboratory test animals, individuals will vary in their sensitivity and can die as a result of inability to avoid predation, secure prey or thermoregulate. Numerous pen studies were conducted with cottontail and jack rabbits exposed to single applications ranging from 1 to 25 lbs ai/ A. While no mortality occurred to cottontails, at the 2 lb ai/ A rate and above jackrabbits suffered 100% mortality. Secondary poisoning did not occur when the jackrabbit carcasses were fed to a number of avian and mammalian carnivores. The apparent difference between the pen study results and the acute mortality predicted in the risk assessment screen is largely due to the possibility that the calculated 1 day LC50s ( ranging from 2 to 12.7 ppm) discounts the rapid metabolism of disulfoton. However, using the demeton LC50 of 320 ppm with its wide ranging confidence interval ( 0 to infinity) also adds uncertainty to the question of disulfoton s acute risk to mammals. Chronic risk to mammals is predicted. As was previously discussed in the above acute and chronic sections for birds, there are several reasons why small mammals are likely to be at even greater risk, not the least of which is the extremely low NOAEC of 0.8 ppm. All modeled and empirically derived residues for all sites exceed the chronic risk level of concern for mammals. Finally, the persistence of the sulfone and sulfoxide degradates, which are also toxic to mammals, increases the likelihood of chronic risk to mammals. Non­ target Insects: Disulfoton and its sulfoxide and sulfone degradates are moderately to highly toxic to bees, however a residual study with honey bees indicated no toxicity for applications up to 1 lb ai/ A. Freshwater Fish: Most of the modeled use patterns did not exceed the acute risk levels of concern for freshwater fish. Only the two soil applications at 4.0 lb ai \ A of the liquid formulation exceeded acute risk. All other scenarios exceeded the restricted use and endangered species levels of concern. There is, however, a large amount of variation in freshwater fish species sensitivity to disulfoton, , as evidenced in the toxicity data table. The microcosm study included bluegill sunfish. Following the last application of 30 ppb, 10% of the fish died. Several kills of freshwater fish have occurred from applications of disulfoton to different crops­ ­ both as registered uses as well as from misuse. Chronic risk to freshwater fish may occur from uses where single application rates are equal to 4 lb ai/ a and from 3 applications of 1 lb ai/ A. . The single freshwater fish species ( rainbow trout) , for which chronic toxicity data was available, demonstrates significantly less sensitivity to disulfoton than several other species ( bluegill sunfish, bass, guppy) . Therefore, an estimated chronic NOEC value was calculated using the chronic to acute ratio for the rainbow trout, as described earlier. Based on the estimated chronic NOAEC for bluegill, chronic effects would 12 occur from the present uses on tobacco, foliar treatments of potatoes and repeated soil treatments of cotton. Christmas tree plantations were not modeled, however the high application rate ( possibly 47 lbs ai/ A) and sloped land may be a potentially risky site. Freshwater Invertebrates: All modeled crop scenarios exceeded the acute risk level of concern, but the highest risk quotients were less than 10. Again, the risk is further increased due to the toxicity and persistence of the degradates of disulfoton. Microcosm study results indicated that there was recovery of most phyla examined at 3 ppb and long term impacts for most phyla at 30 ppb. Therefore 10 ppb is probably a concentration where short term effects will occur, but recovery can be anticipated. Chronic risk to freshwater invertebrates is predicted to from the use of disulfoton. All of the modeled crop scenarios greatly exceeded the level of concern, sometimes by a factor of several hundred. Invertebrate life­ cycle testing with disulfoton shows that it impacts reproductive parameters ( number of young produced by adults) in addition to survival and growth. The 21 day average EECs for the modeled sites ranged from 4.3 to 17.9 ppb. For the most part these EECs are within the range where recovery was occurring in the microcosm. However there is uncertainty as to how much more reliable the microcosm may be as a predictor of safety. Estuarine and Marine Fish: Although acute and restricted risk levels of concern were not exceeded for estuarine and marine fish, the endangered species level of concern was exceeded for several of the modeled crop scenarios ( cotton, potatoes and wheat) . As was note among the freshwater fish, there can be substantial species differences in sensitivity to disulfoton. Therefore, it is possible that the single marine/ estuarine fish species tested ( Sheepshead minnow) does not fully represent the true range of sensitivity found in a marine or estuarine ecosystem, and this assessment may therefore underestimate the true risk to marine/ estuarine fish. There is also some uncertainty in using the PRZM/ EXAMS EECs derived for ponds to predict exposure to marine/ estuarine organisms. The scenarios modeled are based on hydrologic data for freshwater habitats. The exposure in a marine or estuarine habitat may be higher or lower than that predicted for a freshwater habitat, resulting in higher or lower risk to marine/ estuarine organisms. Chronic risk to estuarine and marine fish is predicted from the use of disulfoton. Both early life­ stage and full life­ cycle testing demonstrated a variety of effects at low levels of disulfoton. Risk quotients based on the early life­ stage toxicity endpoint exceeded the level of concern for cotton, potatoes and tobacco. The highest risk quotients were based on numerous life­ cycle toxicity endpoints ­ ­ fecundity, hatching success and growth; consequently the chronic level of concern was exceeded for all modeled scenarios. Estuarine fish spawning in the upper reaches of tributaries of bays would be a greatest risk. However the likelihood of this risk is uncertain for several reasons: 1) the required time the adults must be exposed to disulfoton in order for their reproductive systems to be effected and 2) the residency time of disulfoton residues in tidal or flowing water. Even if adults are effected after an exposure of only a week, disulfoton may be moved out of an area within several days. Estuarine and Marine Invertebrates: Three of the five modeled scenarios ( cotton, potatoes, and tobacco) resulted in exceedences of the estuarine/ marine invertebrate acute risk level of concern. All the remaining uses exceeded the restricted use level of concern. Similar uncertainty 13 exists as to the validity of the exposure scenario for invertebrates as was just described for estuarine fish. Chronic risk to marine/ estuarine invertebrates is predicted. All of the modeled crop scenarios exceeded the chronic level of concern. The much shorter life cycle of invertebrates as compared to fish, increases the likelihood that only a brief exposure ( a few day or even hours) of adults to disulfoton concentrations around the NOAEC is sufficient to negatively impact reproduction. The degree to which the freshwater microcosm is a predictor of safety for the estuarine invertebrates in highly uncertain. Only the mysid shrimp has been tested and it was acutely and chronically less sensitive than freshwater Daphnia. Therefore, on the basis of this limited data, the chronic impact to estuarine invertebrates not only appears to be lower than for freshwater invertebrates, but is likely to be low. Nontarget Plants: Currently, terrestrial and aquatic plant testing is not required for pesticides other than herbicides except on a case­ by­ case basis. Nontarget plant testing was not required for disulfoton, so the risk to plants could not be assessed at this time. There are phytotoxicity statements on the label, however, as well as some incident reports of possible plant damage from the use of disulfoton, so there is the potential for risk to nontarget plants. Summary of Risk Assessment of North Carolina 24c for use in Christmas Tree Farms Christmas tree farms and the adjacent areas ­ ­ forests and/ or pasture provide excellent habitat for a great variety of wild life. The use of granular disulfoton suggests that there is acute risk to small birds and mammals. The North Carolina Christmas Tree community has submitted numerous testimonials emphasizing the ever increasing numbers and diversity of wild life . This includes game animals such as turkey rearing young amidst the Christmas trees, song birds, rodents and foxes. Although this information is intended to suggest there is little or no negative impact from not only disulfoton, but other pesticides or cultural practices as well, the Agency would prefer to receive documented surveys or research before making a final determination. There were no detections of disulfoton or its metabolites in the ground­ water monitoring study conducted in North Carolina by the North Carolina Departments of Agriculture and Environment, Health, and Natural Resources. Seven Christmas tree, one wheat, and two tobacco growing areas were sampled for disulfoton residues. Limitations of the study include that sites were sampled only twice and the limits of detections were high ( e. g. , > 1.0 µ g/ L) for some of disulfoton analytes. Uncertainties associated with the study include whether two samples from eight wells are adequate to represent the ground­ water concentrations of disulfoton residues, did DRASTIC correctly identify a site' s vulnerability, and were the wells placed down­ gradient of the use areas. The use of Disulfoton 15 G in Christmas tree farms at this time cannot be modeled for potential surface water contamination. EFED assumes the estimated concentration for the North Carolina 24 ( c) use pattern ­ ­ 2.75 lbs ai/ A unincorporated ­ ­ may be similar to the values for the single 4.0 lb ai/ A incorporated application of granular disulfoton to tobacco. Based on this assumption there is acute risk to aquatic invertebrates and chronic risk to freshwater fish and aquatic invertebrates. 14 The North Carolina Christmas tree industry submitted two surveys of streams in the Westerns region. The surveys followed a protocol for looking at macro invertebrates to assess the impact of agricultural practices associated with Christmas tree farming. In summary, the two surveys suggests that when conservation measures associated with Christmas tree farming in the Western counties of North Carolina are implemented, there may be only slight, short term impact to aquatic macro invertebrates from disulfoton use. Aquatic macro invertebrates appear to have the capacity to recover from any impact that could be caused by disulfoton use on Christmas trees in Western North Carolina. C. Mitigation The use of disulfoton at single application rates of 1.0 lb ai/ A and greater, and multiple application rates of 0.5 lb ai/ A and greater, poses an acute risk to birds, mammals, fish, and aquatic invertebrates, as well as to nontarget insects. EFED believes that amending label rates to the lowest efficacious rate as a maximum, as well as restricting the number of applications per year and lengthening the application interval, would reduce acute risk to terrestrial and aquatic organisms. Requiring in­ furrow applications wherever feasible, and eliminating banded applications of granular disulfoton with narrow row spacing, would also reduce the risk to nontarget organisms, especially birds and mammals. Eliminating aerial applications of disulfoton and imposing buffer strips around aquatic habitats would reduce the risk to aquatic organisms. Risk to bees and other nontarget insects could be lowered by not applying disulfoton when the insects are likely to be visiting the area. Qualitative comparative ecological risk assessment between present and proposed disulfoton uses. Bayer has proposed the following changes to some use patterns assessed by the Agency that would reduce the ecological risk from Di­ syston 8E: * cancel aerial applications to cotton and wheat. * cancel foliar applications to cotton. The table reflects additional changes proposed by Bayer. 15 Table 1 Comparison of present and proposed changes in 4 use patterns of Di­ syston 8E Present Use Proposed Use Rate / Number of Applications / Interval / Incorp. Depth/ method 1 Rate/ Number of Applications / Interval/ Incorp. Depth/ method 1 lb. ai/ A / # app. / days / inches lb. ai/ A / # app. / days / inches cotton 1.0/ 3/ 21/ 0/ gs cotton 1.0/ 1/ ­ / 0/ gs potatoes 4.0/ 2/ 14/ 2.5/ gs potatoes 3.0/ 1/ ­ / 2.5/ gs potatoes 1.0/ 3/ 14/ 0/ af potatoes 0.5/ 3/ 14­ / 0/ af wheat 0.75/ 2/ 30/ 0/ gs wheat 0.75/ 1/ ­ / 0/ gs 1 Method of application: f = foliar and s = soil; gs = ground spray, af = aerial spray­ foliar Risk to Birds and Mammals Canceling aerial application to wheat and cotton reduces significantly the potential for exposing edge of field food items and vegetation. Canceling foliar applications to cotton reduces the opportunity for exposure, by reducing the food items that are directly sprayed. As the discussion below explains, field monitoring indicates that ground spray to soil reduces substantially the residues on food items from those residues predicted from the nomograph. Potato aerial foliar at 0.5 lb ai/ acre Biological field testing ( MRID 41359101) suggests that significant acute risk to mammals from foliar sprays is unlikely at a single application of 1 lb ai/ acre or lower. Reducing the potato rate from 1 lb ai/ acre 3 times, to 0.5 lb ai/ acre 3 times, substantially lowers the acute risk to mammals. Wheat, potato and cotton ground spray to soil Field residue monitoring ( MRID 41118901) indicates that residues on food items following ground applications to soil are significantly lower than would be expected from direct application to vegetation. Peak residues following the first of two treatments at 3 lb ai/ acre ( in furrow) ranged from 0.9 ppm ( invertebrates and edge of field vegetation) , to 26 ppm ( potato foliage) . The second treatment at 3 lb ai/ acre side dressing ( 6­ 7 weeks later) resulted in peak residues of 1.8 ( invertebrates) , 44 ppm potato foliage, and 54 ppm ( edge of field vegetation) . The residues from these applications are not only lower than those estimated using the nomograph, but also lower than the field residues resulting from foliar applications. In the foliar residue monitoring study ( 3 aerial applications at 1.0 lb ai/ acre) the peaks were: invertebrates ( 16 ppm) and vegetation ( 154 ppm) . The proposed changes would greatly reduce exposure terrestrial species. 16 Table 2 Comparison of potential acute and chronic risk resulting from proposed changes in 4 use patterns of Di ­ syston 8E for birds and mammals Present Use Birds Mammals Proposed Use Birds Mammals Rate / Number of Apps / Interval / Incorp. Depth/ method 1 ac ch ac ch Rate / Number of Apps / Interval / Incorp. Depth/ method 1 ac ch ac ch lb. ai/ A / # app. / days / inches lb. ai/ A / # app. / days / inches cotton 1.0/ 3/ 14/ 0/ gs E Y R Y cotton 1.0/ 1/ ­ / 0/ gs no Y E Y potatoes 4.0 / 2/ 14/ 2.5/ gs R Y A Y potatoes 3.0/ 1/ ­ / 2.5/ gs E Y R Y potatoes 1.0/ 3/ 14/ 0/ af R Y A Y potatoes 0.5/ 3/ 14­ / 0/ af R Y R Y wheat 0.75/ 2/ 30/ 0/ gs E Y R Y wheat 0.75/ 1/ ­ / 0/ gs no Y E Y 1 Method of application: f = foliar and s = soil; g = ground and a = aerial Acute = ac; Chronic = ch Acute risk LOC is exceeded= A; Restricted use LOC is exceeded= R; Endangered Species LOC is exceeded= E; No acute LOC is exceeded= no; LOC for chronic risk is exceeded= Y; LOC for chronic risk is not exceeded= N. Risk to fish and aquatic invertebrates The following table summarizes the results of modeling the proposed new uses. The EECs were reduced from the present registered use patterns: 17 Table 3 Tier II Upper Tenth Percentile EECs for Disulfoton Parent based on proposed new maximum label rates and management scenarios for cotton, potatoes, and spring wheat in farm pond. Estimated using PRZM3/ EXAMS. Crop Disulfoton Application Concentration ( µ g/ L) ( 1­ in­ 10 annual yearly maximum value) Mean of Annual Means ( µ g/ L) Rate / Number of Apps / Interval / Incorp. Depth/ method 1 lb. ai/ A / # / days / inches Peak 96­ Hour Avg. 21­ Day Avg. 60­ Day Avg. 90­ Day Avg. Annual Avg. Cotton 1. 00/ 1/ ­ / 0/ gs 10.31 9.38 6.83 3.54 2.42 0.62 0.23 Potatoes 3.00/ 1/ ­ / 2.5/ gs 2.42 2.18 1.67 0.84 0.57 0.15 0.12 Potatoes 0.5/ 1/ ­ / 0/ af 7.51 6.62 5.20 3.45 2.42 0.62 0.57 Spr. Wheat 0.75/ 1/ ­ / 0/ gs 1.02 0.91 0.67 0.41 0.28 0.08 0.05 1 Method of application: f = foliar and s = soil; g = ground and a = aerial 18 The following tables reflect a qualitative comparative risk assessment for aquatic and estuarine organisms. Table 4 Comparison of potential acute and chronic risk resulting from proposed changes in 4 use patterns of Di ­ syston 8E for freshwater fish and invertebrates Present Use Fish Invertebrates Proposed Use Fish Invertebrates Rate / Number of Apps / Interval / Incorp. Depth/ method 1 ac ch ac ch Rate / Number of Apps / Interval / Incorp. Depth/ method 1 ac ch ac ch lb. ai/ A / # / days / inches lb. ai/ A / # / days / inches cotton 1.0/ 3/ 14/ 0/ gs R Y A Y cotton 1.0/ 1/ ­ / 0/ gs R N A Y potatoes 4.0/ 2/ 14/ 2.5/ gs R Y A Y potatoes 3.0/ 1/ ­ / 2.5/ gs E N A Y potatoes 1.0/ 3/ 14/ 0/ af R Y A Y potatoes 0.5/ 3/ 14­ / 0/ af R N A Y wheat 0.75/ 2/ 30/ 0/ gs R N A Y wheat 0.75/ 1/ ­ / 0/ gs no N R Y 1 Method of application: f = foliar and s = soil; g = ground and a = aerial Acute = ac; Chronic = ch Acute risk LOC is exceeded= A; Restricted use LOC is exceeded= R; Endangered Species LOC is exceeded= E; No acute LOC is exceeded= no; LOC for chronic risk is exceeded= Y; LOC for chronic risk is not exceeded= N. Table 5 Comparison of potential acute and chronic risk resulting from proposed changes in 4 use patterns of Di ­ syston 8E for estuarine fish and invertebrates Present Use Fish Invertebrates Proposed Use Fish Invertebrates Rate / Number of Apps / Interval / Incorp. Depth/ method 1 ac ch ac ch Rate / Number of Apps / Interval / Incorp. Depth/ method 1 ac ch ac ch lb. ai/ A / # / days / inches lb. ai/ A / # / days / inches cotton 1.0/ 3/ 14/ 0/ gs no Y A Y cotton 1.0/ 1/ ­ / 0/ gs no Y A Y potatoes 4.0/ 2/ 14/ 2.5/ gs no Y R Y potatoes 3.0/ 1/ ­ / 2.5/ gs no N R N potatoes 1.0/ 3/ 14/ 0/ af no Y A Y potatoes 0.5/ 3/ 14­ / 0/ af no Y A Y wheat 0.75/ 2/ 30/ 0/ gs no Y A Y wheat 0.75/ 1/ ­ / 0/ gs no N E N 1 Method of application: f = foliar and s = soil; g = ground and a = aerial Acute = ac; Chronic = ch Acute risk LOC is exceeded= A; Restricted use LOC is exceeded= R; Endangered Species LOC is exceeded= E; No acute LOC is exceeded= no; LOC for chronic risk is exceeded= Y; LOC for chronic risk is not exceeded= N. 19 Summary EFED supports the proposed use modifications, and concurs that generally they reduce risk to nontarget organisms to varying degrees. Although there remains the concern for hypersensitive birds and mammals, the acute risk to most birds and mammals is reduced substantially. The greatest risk reduction to fish and aquatic invertebrate are soil applications to potatoes and wheat. There appears to be little changes in acute risk to aquatic organisms from the proposed modifications to cotton and potatoes ( aerial application) . Chronic risk to terrestrial and aquatic organisms are likely to be reduced; but with less certainty, because the duration of exposure required to produce adverse chronic effects in the field are not available. Data Gaps: The following environmental fate requirements are not satisfied for disulfoton, D. sulfoxide, and D. sulfone: 162­ 3: Anaerobic Aquatic Metabolism 162­ 4: Aerobic Aquatic Metabolism 163­ 1: Mobility ­ Leaching and adsorption/ desorption for D. sulfone and D. sulfoxide. Additionally, there is limited environmental fate data available for the sulfone and sulfoxide degradates. Data on the fate of these degradates in soil and water would allow additional characterization of the risks they present to nontarget organisms. The following ecological effects data requirements are not satisfied for disulfoton: 122­ 1: Tier I Terrestrial Plant Testing 122­ 2: Tier I Aquatic Plant Testing ( 123­ 1 and 123­ 2, Tier II testing, are reserved pending the results of Tier I testing) . 71­ 3 Wild mammal testing subacute dietary ( LC50) . The value added for the wild mammal test is high. This study could resolve the issue between the calculated 1 day LC50 ( ranging from 2­ 12 ppm) derived from the acute rat acute oral of 1.9 mg/ kg and the demeton LC50 study ( 320 ppm) with 95% C. I. ( 0 to infinity) . The risk assessment for mammals would be refined with greater certainty. Manufacturing­ Use Products This pesticide is extremely toxic to birds, mammals, fish and aquatic invertebrates. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public waters unless this product is specifically identified and addressed in an NPDES permit. do not discharge effluent containing this product to sewer systems without previously notifying the sewage treatment plant authority. For guidance, contact your State Water Board or Regional Office of the EPA. 20 End­ use Products Non granular products: This pesticide is extremely toxic to birds, mammals, fish and aquatic invertebrates. Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high­ water mark. Drift and runoff may be hazardous to aquatic organisms in neighboring areas. Do not contaminate water when disposing of equipment washwater or rinsate. Granular products: This pesticide is extremely toxic to birds, mammals, fish and aquatic invertebrates. Collect granules spilled during loading or application. . Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high­ water mark. Runoff may be hazardous to aquatic organisms in neighboring areas. Do not contaminate water when disposing of equipment washwater or rinsate. Disulfoton Bee Mitigation ­ Suggested Precautionary Label Language for non granular products: This pesticide is toxic to bees. Application should be timed to coincide with periods of minimum bee activity, usually between late evening and early morning. Surface Water Advisory This product may contaminate water through drift of spray in wind. This product has a high potential for runoff for several months. Poorly draining soils and soils with shallow watertables are more prone to produce runoff that contains this product. Labels for farmers should add the following to the previous statement: A level, well maintained vegetative buffer strip between areas to which this product is applied and surface water features such as ponds, streams, and springs will reduce the potential for contamination of water from rainfall­ runoff. Runoff of this product will be reduced by avoiding applications when rainfall is forecasted to occur within 48 hours. Labels for home owners should add the following to the previous statement: Avoid applying this product to ditches, swales, and drainage ways. Runoff of this product will be reduced by avoiding applications when rainfall is forecasted to occur within 48 hours. Ground Water Advisory Note to CRM: Disulfoton residue detections in ground water range from 0.04 to 100 ppb; detections are up to 300 times the Health Advisory ( 0.3 ppb) . There is a high potential for degradates to contaminate ground water. Because disulfoton degradates are persistent, apparently mobile, and parent disulfoton has been found in ground water, a ground water label advisory is required. The following label language is appropriate: 21 " Disulfoton is known to leach through soil into ground water under certain conditions as a result of label use. Use of this chemical in areas where soils are permeable, particularly where the water table is shallow, may result in ground­ water contamination. " Spray Drift Since disulfoton can be applied aerially, current cautionary labeling for the spray drift of aerially applied pesticides must be used. 22 Table of Contents Amended 8/ 26/ 00 from 01/ 13/ 00 from 10/ 07/ 99 from 8/ 26/ 99 1. Use Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2. Exposure Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 A. Chemical profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 B. Environmental Fate Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 C. Terrestrial Exposure Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 D. Water Resources Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 I. Summary and conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 ii. Application rates used in modeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 iii. Modeling scenarios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 iv. Modeling procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 v. Modeling results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 vi. Monitoring data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 vii. Limits of this analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 3. Ecological Effects Hazard Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 A. Toxicity to Terrestrial Animals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 I. Birds, Acute and Subacute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 ii. Birds, Chronic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 iii. Mammals, Acute and Chronic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 iv. Insects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 v. Terrestrial Field Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 B. Toxicity to Freshwater Aquatic Animals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 I. Freshwater Fish, Acute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 ii. Freshwater Fish, Chronic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 iii. Freshwater Invertebrates, Acute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 iv. Freshwater Invertebrates, Chronic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 v. Freshwater Field Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 C. Toxicity to Estuarine and Marine Animals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 I. Estuarine and Marine Fish, Acute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 ii. Estuarine and Marine Fish, Chronic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 iii. Estuarine and Marine Invertebrates, Acute . . . . . . . . . . . . . . . . . . . . . . . . 44 iv. Estuarine and Marine Invertebrates, Chronic . . . . . . . . . . . . . . . . . . . . . . . 45 v. Estuarine and Marine Field Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 D. Toxicity to Plants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 I. Terrestrial Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 ii. Aquatic Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 4. Ecological Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 A. Risk to Nontarget Terrestrial Animals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 I. Birds and Mammals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 ii. Insects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 B. Risk to Nontarget Aquatic Animals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 . C. Risk to Nontarget Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 5. Endangered Species Consideration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 6. Ecological Incident Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 7. Risk Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71 A. Characterization of Fate and Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72 I. Water Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72 a. Surface Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72 b. Ground Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 B. Characterization or Risk to Nontarget Species . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 C. Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 8. References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84 9. Appendices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 I. Use of Disulfoton by Crop and State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 II. Chemical Structure of Disulfoton . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 III. Assessment of STORET Monitoring Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 IV. Environmental Fate and Chemistry Study Identification . . . . . . . . . . . . . . . . . . . . . . . . 92 V. Environmental Fate Data Requirements Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 VI. Ecological Effects Data Requirements Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 VII. Percent Crop Area Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 VIII. PRZM and EXAMS values for Index Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 99 IX. PRZM and EXAMS Input and EXAMS Output files Table . . . . . . . . . . . . . . . . . . . . 100 1 1. Use Characterization for Disulfoton Disulfoton is a systemic organophosphate insecticide, acaracide ( miticide) registered for use to control aphids, thrips, mealybugs, other sucking insects, and spider mites on a variety of terrestrial food crops ( coffee, peppers, broccoli, brussels sprouts, cabbage, cauliflower, lettuce, spinach, asparagus, pecan, radish, and raspberries) , terrestrial food and feed crops ( tomato, barley, corn, oats, triticale, wheat, cotton, peanut, peas, sorghum, soybeans, potatoes, beans, and lentils) , terrestrial feed crops ( bermudagrass, and alfalfa) , and terrestrial nonfood crops ( Christmas tree plantations, ornamentals, and non­ bearing fruit) . The total use of disulfoton for 1997 was approximately 1.7 million lbs ai. Cotton has the greatest use of disulfoton ( 420,000­ 840,000 lb ai/ yr) , accounting for 61% of the disulfoton market. Wheat has the next largest percentage of the market, at 16% ( 180,000­ 354,000 lb ai/ yr) . The largest use state is California ( 16% of the market, 272,000 lb ai/ yr) , followed by Louisiana ( 11% of the market, 187,000 lb ai/ yr) . Rankings of disulfoton usage by crop and by state are provided in Appendix I. Disulfoton is formulated as 15% granules, 8% emulsifiable systemic, 95% cotton seed treatment, systemic granules ( 1, 2, 5, 10% ) , and 68% concentrate for formulating garden products. Applications are generally soil applied: in­ furrow, broadcast, or row treatment followed by 2­ 3 inch soil incorporation. It can also be applied as a foliar treatment and in irrigation water. Cotton seeds can also be directly treated and planted. Disulfoton can be applied in multiple applications ( up to three) at intervals from 7 to 21 days depending upon the crop. Application rates typically range from about 0.5 to 4.00 lb ai/ A. A Section24( c) Registration for North Carolina Christmas trees allows up to 4.5 lb ai/ A and for the same use, the Federal Section 3 Registration allows for greater than 57 lb ai/ A. 2. Exposure Characterization A. Chemical Profile 1. Common name: disulfoton 2. Chemical name: O, O' ­ diethyl­ S­ [ 2­ ethylthio) ethyl ] phosphorothioate 3. Trade Names: Di­ Syston 4. Physical/ Chemical properties: Molecular formula: C8H1802PS3 Molecular weight: 274.39 Physical state: colorless liquid Specific gravity. 1.144 a 20 E C. Henry' s Law Constant: 2.60E­ 6 Atm. M3/ Mol ( measured) Boiling point: 62 E C at 0.01 mmHg Vapor pressure: ( 20 E C) = 1.8 X 10 ­ 4 mmHg Solubility: in water at 20 E C= 25 ppm; miscible in n­ hexane, dichloromethane, 2­ propanol, toluene 2 B. Environmental Fate Assessment I. Environmental Fate and Chemistry Data The environmental fate and chemistry data base for disulfoton is incomplete for the parent compound. Less fate data are available for the degradation products. The major routes of dissipation are chemical reaction and microbial degradation in aerobic soil and aqueous photolysis and soil photolysis. Volatilization from soil and water is not expected to be significant. Data are unavailable for aerobic and anaerobic aquatic environments. The anaerobic soil metabolism studies have been submitted to the Agency, and will be reviewed by EFED. Disulfoton is essentially stable to hydrolysis at 20 E C at the three pH values tested but is influenced by temperature as hydrolysis is fairly rapid at 40 E C. The overall results of these mechanisms of dissipation appear to indicate that disulfoton has low persistence. Limited data suggests that the degradates are much more persistent. Disulfoton also appears to be more persistent under anaerobic soil conditions than aerobic soil conditions. The adsorption/ desorption studies indicate that disulfoton is slightly to somewhat mobile depending upon the soil. Aged leaching studies suggested that D. sulfoxide and D. sulfone degradates did not leach which is inconsistent with the field data, terrestrial field dissipation studies showed that both degradates leached. Sulfoxide and sulfone degradates of other organophosphate pesticides tend to be more mobile than the parent compound. The individual studies are summarized below. Hydrolysis ( 161­ 1) The primary hydrolysis products were the disulfoton oxygen analog ( POS) at pH 4, a mixture of des­ ethyl disulfoton metabolites of which the major one is des­ ethyl POSO2 at pH 7 and a product obtained at pH 9 which converted to 2­ 2­ ( ethylsulfonyl) ethane sulfonic acid upon treatment with potassium permanganate. The reported hydrolysis half­ lives are 1174 days, 323 days, and 231 days in sterile aqueous buffered solutions at pH s 4, 7, and 9, respectively, for a 30 day study. Consequently, disulfoton is essentially stable to abiotic degradation at 20 E C. At 40 E C, the half­ lives were 30, 23.2, and 22.7 days at pH 4, 7, and 9, respectively. The hydrolysis guideline requirement ( 161­ 1) is fulfilled ( MRID 00143405) . Photodegradation in water ( 161­ 2) Disulfoton had a T1/ 2 of 93 hours. The half­ life for aqueous photolysis ( corrected for the dark control) is 93 hours in a pH 5 buffered solution exposed to natural sunlight ( Latitude 38.05 N; Longitude 84.30 W. ; October 5­ 15. 1987; average temperature 19.4 + 2.08 C ) . For the purpose of modeling ( in the water body) , the rate of disulfoton photolysis in water was considered. Disulfoton sulfoxide was the major degradation product. Control ( dark) samples degraded with a half­ life of > 300 hours. Both reactions followed zero­ order kinetics ( independent of concentration) . The guideline requirement for photo­ degradation in water ( 161­ 2) is fulfilled ( MRID 40471102) . Photodegradation on soil ( 161­ 3) 3 The half­ life of disulfoton was 2.4 days on sandy loam soil plates exposed to natural sunlight. The primary photoproduct was disulfoton sulfoxide in irradiated and dark samples. Less than 10% disulfoton oxygen analog sulfoxide and disulfoton sulfone were detected in the light exposed samples after two days of irradiation. MRID 40789701 was rejected on 8/ 23/ 89 since the proportion of metabolites formed was not presented in the study report. The registrant provided this information in a letter dated 2/ 11/ 92. The photo­ degradation on soil data requirement ( 161­ 3) is fulfilled ( MRID 40471103) . Aerobic soil metabolism ( 162­ 1) Literature suggests that disulfoton is transformed in soil via microbial metabolism and chemical oxidation ( Howard et al. , 1991) . Primary transformation products are D. sulfoxide and D. sulfone. Five oxidative metabolites, that persisted for more than 12 weeks ( 84 days) , have been identified in a paddy soil ( Howard et al. , 1991) . Data generally suggests that in soil disulfoton will initially decline rapidly in soil, but this decline slows with time. Reported " half­ lives" of disulfoton tend to be generally less than 5 days. In soil, the metabolites, D. sulfoxide and D. sulfone, appear to be more persistent > 17 days and > 150 days, respectively ( MRID# 4437391) . The registrant has submitted a several studies to assess the aerobic metabolism rate in soil ( MRID # s 43800100, 40042201; 41585101) . The aerobic soil half­ life was calculated by the registrant to be 15.6 days, however, the reaction did not follow first­ order kinetics ( MRID 43800101) . It was recalculated ( see next paragraph) . Less than 20% of the amount applied remained 7 days after treatment; < 3% remained 60 days after treatment. The major degradates are the sulfoxide ( 58.7% ) at 7 days, and sulfone ( 72% ) at 90 days. At the end of the study ( 367 days) , the sulfone was present at 35% of the applied amount, and the sulfoxide at 2% of the applied amount. Except for the sulfone and sulfoxide degradates, residues were not detectable at 367 days. The aerobic soil metabolism guideline requirement ( 162­ 1) is fulfilled ( MRID 43800101) . As noted above there is an issue as to whether the decline of disulfoton in soil follows first­ order kinetics in this study ( MRID 43800101) . The information reported in MRID 43800101 suggests non­ first order kinetics and a half­ life less than the " calculated" 15.6 days as indicated. The 15.6 day half­ life was calculated by the registrant and only represents a portion of the data ( days 0 through 90, days 122, 241, and 367 were not included) . The slope ( decay rate constant, k) of the transformed ( natural log or ln) ( ln C( t) = ln Co ­ kt, where Co is the initial concentration, C is concentration, and t is time) was significant with p= 0.0001 and a r 2 of 0.888. From a statistical standpoint, a first­ order model using transformed data provides a reasonable estimate of the decline rate. However, the time that the initial pesticide concentration reaches half the initial concentration ( e. g. , half­ life) is less than the 15.6 days suggested by the analysis of the transformed data. The decay rate of disulfoton appears to follow the pseudo first­ order type kinetics over the entire study duration better than when nonlinear regression is applied to untransformed data ( C= Coe ­ kt ) where Co is the initial concentration, C is concentration, t is time, and k is the decay rate constant. The parameter k was estimated by non­ linear regression of C versus time. The half­ life ( when C/ Co = 0.5) was estimated to be 2.57 days ( r 2 = 0.93) . The linear regression of the ln­ transformed dated tended to over estimate disulfoton residues with time whereas the non­ linear regression of the non­ transformed data under estimated the disulfoton residues with time. Approximately, 10 percent of applied radio­ labeled disulfoton ( Di­ 4 Syston) was reported to be in the sulfoxide state at time zero ( day 0 < then 6 hours) which suggests rapid oxidation to the corresponding sulfoxide metabolite. Two additional aerobic soil metabolism studies ( MRID# s 40042201; 41585101) submitted by the registrant, determined to be supplemental studies by EFED, also provided additional information which was considered. These studies had estimated aerobic half­ lives of 2.4 and 1.9 days, respectively. A half­ life of 1.9 days ( MRID 41585101) was estimated using the ln­ transformed disulfoton percentages from only the first three days ( 0, 0.25, 1, and 3 days) of the experiment, the remaining days 7, 14, 30, 90, 189, 270 are not considered. The decline of parent disulfoton in these studies also appeared not to follow first­ order kinetics, but pseudo first­ order kinetics. The registrant indicated in a response ( 3/ 8/ 99 To: P. Poli, From: J. S. Thornton) that the half­ lives for the studies submitted as MRID # 43800101 and 41585101 were 5.5 and 4.1 days, respectively. Because these half­ lives are longer ( more conservative) than those estimated by EFED ( see above) , these values were used in the modeling for the water assessment. The metabolites ( D. sulfoxide and D. sulfone) tended to be more persistent with T1/ 2 of ~ 17 days and ~ 150 days, respectively ( MRID# 4437391) . The registrant indicates, non­ guideline study ( modeling exercise) that the DT50 for disulfoton, sulfoxide, and sulfone is 5.5, 17, and 150 days, respectively ( MRID 4437391) . The equations used to estimate these values were not specified, thus, the DT50s ( rate constants) could not be confirmed. Anaerobic soil metabolism ( 162­ 2) Several anaerobic soil metabolism studies have been submitted to the EPA ( MRID# s 43512201, 43042503. The studies indicate that disulfoton is more persistent under anaerobic soil conditions compared to aerobic soil conditions. EFED will conduct a detailed review of these studies. Anaerobic aquatic metabolism ( 162­ 3) This study ( MRID 43042503) cannot be used to fulfill data requirement 162­ 3. Material balances were too low, declining from 106% immediately post­ treatment to 78.7% at 202 days. Only 65% of the intended application was available at the start of the study. The study cannot be upgraded; a new anaerobic aquatic study or an anaerobic soil metabolism study must be submitted for disulfoton. Aerobic aquatic metabolism ( 162­ 4) No data on aerobic aquatic metabolism of disulfoton or its metabolites have been submitted. This information must be submitted by the registrant. Mobility ­ Leaching and Adsorption/ Desorption. ( 163­ 1) Adsorption/ desorption studies of disulfoton indicated that it is slightly mobile to somewhat mobile depending on the soil. Adsorption/ desorption coefficients of various soil types are 5 tabulated below. Table 1. Kd and Koc Adsorption/ Desorption Values for Disulfoton for four soils Soil Texture Silt Loam Sand Clay Loam Sandy Loam Kd 6.85 4.67 4.47 9.66 Koc ( ads. ) 449 888 386 483 Koc ( des. ) 629 1340 547 791 The average organic carbon normalized Freundlich Kads was estimated to be 551.5 mL/ g soil carbon from the data summarized in the above Table 1. The Koc ( ads. ) model generally appears to be appropriate as Kads increase with organic carbon content and the 1/ n term in the Freundlich equation were close to 1 ( so Kads ~ Kd) . In a second report, # 66792, parent Freundlich K values ( 7.06 to 14.29) indicate that disulfoton is adsorbed to a moderate degree which also reflects low mobility in soils. The average Di­ Syston Rf value was 0.22 on six soils which also indicates low mobility of the parent disulfoton. The correlation coefficients describing the degree of data conformity to the Freundlich equation ranged from 90.3 to 99.9% . The 1/ n values for the three soils were 1.002, 0.980, and 0.975. Calculated Kocs were 641, 752, and 839. The mobility­ leaching and adsorption/ desorption guideline requirement ( 163­ 1) is fulfilled ( MRID # 443731­ 03 and 00145469) . These data were also recorded in Bayer' s 11/ 30/ 93 letter to SRRD, MRID ­ 430425­ 00 pages 3 and 4. ) Adsorption/ desorption data are needed for D. sulfoxide and D. sulfone. Mobility ­ Leaching of Aged Di­ Syston ( 163­ 1) This 1986 study ( Acc. # 00145470) was not conducted in accordance with acceptable guidelines, and the 1986 results were not consistent with current data using guideline studies. Recent data indicate that the degradates will leach to lower depth, but the 1986 study indicated no leaching of sulfoxide and sulfone degradates. A new column leaching study is not required, because other existing data fulfill the requirement. Laboratory Volatility ( 163­ 2) Disulfoton volatilized at maximum of 0.026 and 0.096 µ g/ Cm 2/ hr from sand soil adjusted to 25% and 75% of field capacity at 0.33 bar respectively, incubated in dark for 21 days at 25 E C with an air flow of approximately 300 mL/ minute. Maximum volatilization occurred within 24 hours following treatment. The vapor pressure of disulfoton was reported to be 7.2 X 10 ­ 5 mBar at 20 E C and 1.3 X 10 ­ 5 mBar at 25 E C. Freundlich Kads for the sand soil was determined to be 0.172. The guideline requirement for laboratory volatility ( 163­ 2) has been fulfilled ( MRID 42585802) 6 Field Volatility ( 163­ 2) Maximum concentration observed in air at 1 foot above ground was 22.2 ng/ L. Disulfoton concentrations, after 6 hours, at the 5 foot level were not detectable. Bayer, Inc. submitted additional data, e. g. , ads. / des. Kds, and cloud covering on the days of the experiment. The guideline requirement for field volatility ( 163­ 2) has been fulfilled ( MRID 40471105) . Terrestrial Field Dissipation ( 164­ 1) Disulfoton applied at 8 lbs. / ac dissipated with a T1/ 2 of 2 to 4 days from the upper 6 inches of sand/ sandy loam and loamy sand/ sandy loam plots in California. Parent disulfoton was detected only in the upper 6 inches of soil, the sulfoxide and sulfone degradates were detected to a depth of 18 inches. The guideline requirement for terrestrial field dissipation ( 164­ 1) has been fulfilled ( MRID 43042502) . Fish Bioaccumulation ( 165­ 4) From 60.8 to 85.9 ppb 14 C residues in edible fish and 38.1 to 39.9 ppb in the inedible fish tissues were not characterized. After 14 days depuration, fillet contained 21% of the applied residues, viscera 18.1% , and whole fish 22% . Bioconcentration factors were 460X for whole fish, 700X for viscera, and 460X for fillet. Bayer submitted data, at the Agency s request, which indicated that there was no mortality and no growth during the study. The bioaccumulation guideline ( 165­ 4) has been partially fulfilled ( MRID 43042501, 43060101, 40471106, and 40471107) . No further bioaccumulation testing is required for parent disulfoton, however, bioaccumulation information, or at least Kow determination, for the sulfone and sulfoxide degradates would be helpful for risk assessment purposes. Foliar Dissipation ( Non­ Guideline Study ­ Supporting Information) The foliar dissipation rate of 3.3 days is based on field monitoring data ( MRID # 41201801) . Disulfoton was aerially applied to potatoes 3 times at 1 lb ai/ acre in Michigan. Potato foliage was collected from five different treated fields with six sampling stations in each field. Samples were collected the day before and the day after each of the three treatments, and then on day 7 and 14 after the third ( final) treatment. The foliar dissipation rate estimates are based on the samples collected after the third treatment. The following table shows the average residue levels on potato foliage on days 1, 7 and 14 from the five fields, across all 6 sample stations and the average for all fields. EFED determined that the 90 th percentile upper bound foliar dissipation half­ life for disulfoton of 3.3 days is used for both terrestrial exposure assessment, and in PRZM­ EXAMS when foliar dissipation is applicable 7 Table 2. Residue data and the calculated foliar dissipation half­ life based on measured residues of disulfoton on potato foliage after the third application. Residues in g/ g ( ppm) . Time field 1* field 2* field 3* field 4* field 5* average of all fields day 1513634404040 day 7 4.8 4.7 8.5 5.3 5.9 5.8 day 14 1 0.9 1.9 1.6 4.2 1.9 half­ life ( days) 2.3 2.4 3.1 2.8 4 2.98 upper 90% CL 3.3 * average across all stations C. Terrestrial Exposure Assessment For pesticides applied as a nongranular product ( e. g. , liquid, dust) , the estimated environmental concentrations ( EECs) on food items following product application are compared to LC50 values to assess risk. The predicted 0­ day maximum and mean residues of a pesticide that may be expected to occur on selected avian or mammalian food items immediately following a direct single application at 1 lb ai/ A are tabulated below. Table 3. Estimated Environmental Concentrations on Avian and Mammalian Food Items ( ppm) Following a Single Application at 1 lb ai/ A) Food Items EEC ( ppm) Predicted Maximum Residue 1 EEC ( ppm) Predicted Mean Residue 1 Short grass 240 85 Tall grass 110 36 Broadleaf/ forage plants, and small insects 135 45 Fruits, pods, seeds, and large insects 15 7 1 Predicted maximum and mean residues are for a 1 lb ai/ A application rate and are based on Hoerger and Kenaga ( 1972) as modified by Fletcher et al. ( 1994) . Predicted residues ( EECs) resulting from multiple applications are calculated in various ways. For this assessment, maximum disulfoton EECs were calculated using Hoerger and Kenaga ( 1972) as modified by Fletcher et al. ( 1994) . These EECs served as inputs into the FATE 8 program. The FATE program is a first order dissipation model, i. e. , the pesticide is applied repeatedly, but degrades over time from the first application to some assigned time there after. In the case of disulfoton the time period was 30 days. A foliar degradation half life of 3.3 days was selected based on a field monitoring study ( MRID # 41201801) . EEC values for a variety of crops and application rates/ methods are provided in the risk quotient tables in Section 4, Ecological Risk Assessment. D. Water Resources Assessment i. Summary and Conclusions This section presents the assessment of the potential of disulfoton ( and degradates) to contaminate surface water and ground water from label uses. The assessment includes a Tier II estimates of environmental concentrations ( EECs) of disulfoton and total disulfoton residues ( TDR sum of disulfoton, D. sulfoxide, and D. sulfone) in surface water and SCI­ GROW estimates of ground water concentrations, and the available monitoring data which primarily addresses only parent disulfoton. Tier I was not included because EECs levels of concern are generally exceeded for organophosphate insecticides, thus, necessitating a more refined evaluation. The ecological exposure assessment used the standard farm pond scenarios and the drinking water assessment utilized the Index Reservoir and Percent Crop Area concepts. The Tier II modeling of disulfoton residue concentrations in surface water used the PRZM3 and EXAMS models as applied to barley, cotton, potatoes, tobacco, and spring wheat, using maximum label application rates and several application methods. Surface water monitoring data collected by the USGS as part of the National Water Quality Assessment ( NAWQA) ( Gilliom, 1995; USGS, 1997) program, USEPA' s STORET, and any State study that measured disulfoton in surface water were also considered. The potential for disulfoton residues in ground water is assessed using the EFED ground­ water concentration screening model ( SCI­ GROW) and the monitoring data available in EFED s Pesticides in Ground Water Data Base ( PGWDB) ( USEPA, 1992) , USGS NAWQA study ( USGS, 1997) , and STORET ( search date 10/ 16/ 97) . The purpose of this analysis is to provide an estimate of environmental concentrations of disulfoton ( and degradates) in surface water bodies and ground water for use in the human health and ecological risk assessment as part of the registration process. The environmental fate data base is not complete for disulfoton. Limited data indicates that the degradates are much more persistent and mobile than parent disulfoton. Organophosphate degradates are often as toxic as the parent compound and are considered in this assessment as total disulfoton residues ( TDR) . However, as noted, since data are lacking there is considerable uncertainty in these estimates. Surface­ and ground­ water monitoring data available in STORET were evaluated in detail, but were generally not considered due to limitations associated with high detection limits and difficulty in interpreting the data. Detailed discussion of the STORET findings is presented in the Appendix III . The Tier II EEC assessment uses a single site, or multiple single sites, which represents a high­ end exposure scenario from pesticide use on a particular crop or non­ crop use site for ecological exposure assessments. The EECs for disulfoton were generated for multiple crop scenarios using PRZM3.12 ( Carsel, 1997; 5/ 7/ 98) which simulates the erosion and run­ off from an 9 agricultural field and EXAMS 2.97.5 ( Burns, 1997; 6/ 13/ 97) which simulates the fate in a surface water body. PRZM3 and EXAMS estimates for a single site, over multiple years, EECs for a 1 ha surface area, 2 m deep farm pond draining an adjacent 10 ha barley, cotton, potato, tobacco, or spring wheat field. Each scenario, or site, was simulated for 20 to 40 ( depending on data availability) years. EFED estimated 1 in 10 year maximum peak, 4­ day average, 21­ day average, 60­ day average, 90­ day, annual average concentrations, and the mean of the annual averages. Disulfoton ( Di­ Syston) formulations were based upon registered uses on the specific crops. The application rates ( maximum on label ; EPA Reg. No. 3125­ 172, 3125­ 307) , numbers, and intervals are listed in Tables 7a. and 7b. and Tables 8a. and 8b. and environmental fate inputs are listed in Table 6. PRZM simulations were run using maximum application rates, maximum number of yearly applications, and the shortest recommended application interval. Spray drift is determined by method of pesticide application ( and assumed to be 5% for aerial spray; 1% for ground spray, 0% for granular or soil incorporated applications) per EFED guidance for the pond scenarios ( USEPA, 1999) . The PRZM/ EXAMS EECs are generated for high exposure agricultural scenarios and represent one in ten year EECs in a stagnant pond with no outlet that receives pesticide loading from an adjacent 100% cropped, 100% treated field for parent disulfoton and total disulfoton residues. As such, the computer generated EECs represents conservative screening levels for ponds, lakes, and flowing water and should only be used for screening purposes. The EECs have been calculated so that in any given year, there is about a 10% probability that the maximum average concentration of that duration in that year will equal or exceed the EEC at the site. Tier II upper tenth percentile EECs for disulfoton and total disulfoton residues are presented in Tables 7a. and 7b. and 8a. and 8b. for the pond and the index reservoir with PCA adjustment, respectively. The sites selected are currently used by EFED ( standard scenarios) to represent a reasonable at risk soil for the region or regions being considered. . The scenarios selected represent high­ end exposure sites. The sites are selected so that they generate exposures larger than for most sites ( about 90 percent) used for growing the selected crops. An at risk soil is one that has a high potential for run­ off and soil erosion. Thus, these scenarios are intended to produce conservative estimates of potential disulfoton concentrations in surface water. The crop, MLRA, state, site, and soil conditions for each scenario are given in Tables 4 and 5. The SCI­ GROW ( Screening Concentration in Ground Water) screening model developed in EFED ( Barrett, 1997) was used to estimate potential ground water concentrations for disulfoton parent and total disulfoton residues under generic hydrologically vulnerable conditions. . SCI­ GROW provides a screening concentration, an estimate of likely ground water concentrations if the pesticide is used at the maximum allowed label rate in areas with ground water exceptionally vulnerable to contamination. In most cases, a majority of the use area will have ground water that is less vulnerable to contamination than the areas used to derive the SCI­ GROW estimate. ii. Application Rates Used in Modeling The application rates ( Tables 7a and b, 8a and 8b) selected for use in the modeling scenarios 10 were based upon information submitted by the registrant, analysis conducted by BEAD, and the disulfoton ( Di­ Syston) labels. Four factors went into selecting the application rate: 1) the range of ounces or pounds a. i. ; 2) the area or length of row per acre ( which is influenced by row spacing) ; 3) the number of applications; and 4) the application interval. The maximum rate ( ounces or pounds a. i. per crop simulated) and the shortest application intervals were selected. The shorter the distance between the crop rows the greater the application rates on an area basis. iii. Modeling Scenarios Surface Water: The disulfoton scenarios ( Tables 4 and 5) are representative of high run­ off sites for barley in the Southern Piedmont of Virginia ( MLRA 136) , cotton in the Southern Mississippi Valley Silty Uplands of Mississippi ( MLRA 134) , potatoes in the New England and Eastern New York Upland of Maine ( MLRA 144A) , tobacco in Southern Coastal Plain of Georgia ( MLRA 133A) , and spring wheat in the Rolling Till Prairie of South Dakota ( MLRA 102A) . The scenarios chosen are professional best judgement sites expected to produce run­ off greater than would be expected at 90% of the sites where the appropriate crop is grown. Soils property data ( Table 5) and planting date information were obtained from the PRZM Input Collator ( PIC) data bases ( Bird et al, 1992) . The Percent Crop Area ( PCA) values used for the five scenarios for estimated drinking water concentrations are also given in Table 4. 11 Table 4. Crop, location, soil and hydrologic group for each modeling scenario. Crop MLRA 1 State Soil Series Soil Texture Hydrologic Group Period ( Years) PCA 2 Barley 136 VA Gaston sandy clay loam C270. 87 Cotton 131 3 MS Loring silt loam C 20 0. 20 Potatoes 144A ME Paxton sandy loam C 36 0. 87 Tobacco 133A GA Emporia loamy sand C 36 0. 87 Spr. Wheat 102A SD Peever clay loam C 40 0. 56 1 MLRA is major land resource area ( USDA, 1981) . 2 PCA is the Percent Crop Area. 3 Meteorological file met131. met is used in the EFED standard cotton scenario, since the weather station is closer to the simulated site. Table 5. Selected soil properties used modeling. Soil Series ( MLRA) Depth ( in) Bulk Density ( g/ cm 3 ) Organic Carbon ( % ) Field Capacity ( cm 3 / cm 3 ) Wilting Point ( cm 3 / cm 3 ) Gaston ( 136) 16 1.6 1.740 0.246 0.126 84 1.6 0.174 0.321 0.201 50 1.6 0.116 0.222 0.122 Loring ( 131) 10 1.6 1.160 0.294 0.094 10 1.6 1.160 0.294 0.094 105 1.8 0.174 0.147 0.087 Paxton ( 144A) 20 1.6 2.90 0.166 0.66 46 1.8 0.174 0.118 0.38 34 1.8 0.116 0.085 0.035 Emporia ( 133A) 38 1.4 1.16 0.104 0.054 62 1.6 0.174 0.225 0.125 50 1.6 0.116 0.135 0.056 Peever ( 102A) 18 1.35 1.740 0.392 0.202 82 1.60 0.116 0.257 0.177 50 1.60 0.058 0.256 0.176 Ground Water: The SCI­ GROW ( Screening Concentration in Ground Water) screening model developed in EFED ( Barrett, 1997) was used to estimate potential ground water concentrations for disulfoton parent and total disulfoton residues under generic hydrologically vulnerable 12 conditions, but necessarily the most vulnerable conditions. The SCI­ GROW model is based on scaled ground water concentrations from ground water monitoring studies, environmental fate properties ( aerobic soil half­ lives and organic carbon partitioning coefficients­ Koc' s) and application rates. iv. Modeling Procedure Environmental fate parameters used in PRZM3 and EXAMS runs are summarized in Table 6. The standard EFED pond ( mspond) was used. The PRZM3 simulations were run for a period of 36 years on potatoes, and tobacco, beginning on January 1, 1948 and ending on December 31, 1983. Barley was run for 27 years ( 1956­ 1983) and spring wheat was run for 40 years ( 1944­ 1983) . Cotton was run for 20 years of data ( January 1, 1964­ December 31, 1983) . Scenario information is summarized in Tables 4 and 5. The EXAMS loading ( P2E­ C1) files, a PRZM3 output, were pre­ processed using the EXAMSBAT post­ processor. EXAMS was run for the 20­ 40 years using Mode 3 ( defines environmental and chemical pulse time steps) . For each year simulated, the annual maximum peak, 96­ hour, 21­ day, 60­ day, 90­ day values, and annual means in addition to the mean of annual means were extracted from the EXAMS output file REPORT. XMS with the TABLE20 post­ processor. The 10 year return EECs ( or 10% yearly Exceedence EECs) listed in Tables 7a. , 7b. , 8a. and 8b. were calculated by linear interpolation between the third and fourth largest values by the program TABLE20. Table 6. Disulfoton fate properties and values used in ( PRZM3/ EXAMS) modeling. Parameter Value Source Molecular Weight 274.39 MRID 150088 Water Solubility 15 mg/ l @ 20 MRID 150088 Henry s Law Coefficient 2. 60 atm­ m3/ mol EFED One­ liner 05/ 21/ 97 Partition Coefficient ( Koc) 551.5 ( mean of 4 ) MRID 43042500 Vapor Pressure 1.8E­ 04 mmHg EFED One­ liner 05/ 21/ 97 Hydrolysis Half­ lives @ pH 4 pH 7 pH 9 1174 days 323 231 MRID 143405 Hydrolysis Rate Constants ( needed for EXAMS derived from Hydrolysis halflives Kah = ( negative) Knh = 8.88E­ 05 Kbh = 3.58 Aerobic Soil Half­ life ( Disulfoton) 6.12 days ( 0.113/ d) Upper 90% confidence bound on the mean of " half­ lives" for the two aerobic soils tested in the laboratory. MRIDs 40042201, 41585101, 43800101 Aerobic Soil Half­ life 1 ( Total Disulfoton Residues) 259.63 days ( 2.67E­ 03/ d) Upper 90% confidence bound on the mean of half­ lives for the two aerobic soils tested in the laboratory. MRIDs 40042201, 41585101, 43800101 Water Photolysis 3.87 days ( pH = 5) ( 0.179/ d) MRID 40471102 Aerobic Aquatic Half­ life ( Disulfoton) ( Kbaws, Kbacs) 12.2 days ( 0.05682/ day) Estimated per EFED guidance Aerobic Aquatic Half­ life ( Total Disulfoton Residues) ( Kbaws, Kbacs) 259.63 days ( 2.67E­ 03/ d) Did not multiple half­ life by 2 per EFED guidance to account for uncertainty. Half­ lives greater than a year would show residue accumulation. Foliar Dissipation Rate 3.3 days ( 0.21/ d) MRID 41201801 1 Half­ lives for total residues were determined from the total residues at each sampling interval. Total disulfoton residues did follow first­ order kinetic decay ( The slope ( decay rate constant, k) of the transformed ( natural log or ln) ( ln C( t) = ln Co ­ kt, where Co is the initial concentration, C is concentration, and t is time) ) . v. Modeling Results 13 a. Surface water In the Tier II assessment, the mean of the annual mean concentrations of disulfoton ( Table 7a) in a farm pond over multiple years simulated ranged from 0.21 µ g/ L for a two applications ( @ 0.83 lb ai/ a) to barley in Virginia to 1.14 µ g/ L for potatoes in Maine with the three applications at the maximum application rate ( @ 1.00 lb ai/ ac) . The one­ in­ ten year maximum, or peak, estimated concentrations of 26.75 µ g/ L occurred for one 4.0 lb. ai/ ac applications of disulfoton to tobacco in Georgia. For the other scenarios or recommended application rates, the maximum concentrations ranged from 7.14 to 18.46 µ g/ L. Because of limited data, the modeling results, therefore, cannot be confirmed by the monitoring data. Because the degradates of disulfoton ( including oxygen analogs) : sulfoxide and sulfone are also toxic, the EECs of the total disulfoton residue ( TDR) in a farm pond was also considered ( Table 7b) . The overall estimated of the multiple year mean concentrations of TDR in a farm pond over multiple years simulated ranged from 3.89 µ g/ L for two applications at the maximum rate ( 1.00 lb ai/ A) to barley in Virginia to 9.32 µ g/ L for tobacco in Georgia with one application at the maximum application rate ( 4.00 lb ai/ A) . Maximum, or peak, estimated TDR concentrations of 58.47 µ g/ L occurred for one 4.00 lb. ai/ ac application of disulfoton to tobacco. For the other scenarios, the maximum TDR concentrations ranged from 15.32 to 52.93 µ g/ L. There are no monitoring data to evaluate these concentration estimates from PRZM/ EXAMS modeling. Water samples collected, following a fish kill incident in Colorado, contained disulfoton sulfoxide at levels of 29.5­ 48.7 µ g/ L, and disulfoton sulfone at 0.0199­ 0.214 µ g/ L. The source of the disulfoton was Di­ Syston E. C. applied to wheat which was followed by heavy rain fall. ( Incident Report No. I001167­ 001) . The PRZM/ EXAMS estimated disulfoton residue concentrations in surface water appear to be strongly related to the application rate, number of applications, application interval, and method of application and timing to application to rainfall events. 14 Mean of Annual Means ( µ g/ L) 0. 50 0.21 0.48 0. 33 1.14 0.66 0.42 0. 66 Table 7a. Tier II Upper Tenth Percentile EECs for Disulfoton Parent Used on barley, cotton, potatoes, tobacco, and spring wheat for several application ( Label maximum) rates and management scenarios estimated using PRZM3/ EXAMS in standard farm pond. Concentration ( µ g/ L) ( 1­ in­ 10 annual yearly maximum value) Annual Avg. 0. 79 0.49 0.92 0. 44 1.23 1.72 1.15 0. 73 90­ Day Avg. 2. . 82 1.73 3.44 1. 80 4.89 6.87 4.64 2. 76 60­ Day Avg. 3. 79 2.37 4.91 2. 59 6.89 9.94 6.74 3. 81 21­ Day Avg. 5. 96 4.36 8.05 4. 51 10.40 17.89 12.54 5. 47 96­ Hour Avg. 7. 93 6. 32 12.96 6. 40 13.24 24.33 16.79 7. 95 Peak 9. 20 7. 14 14.79 7. 14 15.02 26.75 18.46 8. 90 Disulfoton Application Rate / Number of Apps / Interval / Incorp. Depth / method 1 lb. ai/ A / # / days / inches 1.0 / 2/ 21/ 0/ f 0.83/ 2/ 21/ 0/ s ( granular) 1. 0 / 3/ 21/ 0/ s 4.0 / 2/ 14/ 2.5/ s 1.0/ 3/ 14/ 0/ f 4.0/ 1/ 0/ 2.5/ s ( granular) 4.0/ 1/ 0/ 2.5/ s 0.75/ 2/ 30/ 0/ f Crop Barley Barley Cotton Potatoes Potatoes Tobacco Tobacco Spr. Wheat 1 Method of application: f = foliar and s = soil 15 Mean of Annual Means ( µ g/ L) 4.94 3.89 9.13 4.48 8.37 9.32 7.16 4.73 Table 7b. Tier II Upper Tenth Percentile EECs for Total Disulfoton Residues Used on barley, cotton, potatoes, tobacco, and spring wheat for several application ( Label maximum) rates and management scenarios estimated using PRZM3/ EXAMS in standard farm pond. Concentration ( µ g/ L) ( 1­ in­ 10 annual yearly maximum value) Annual Avg. 7.51 6.60 15.61 6.02 9.75 15.23 13.36 5.65 90­ Day Avg. 16.48 14.46 32.41 10.97 19.33 35.30 31.94 11.29 60­ Day Avg. 17.35 15.02 34.37 12.20 20.88 39.57 35.68 12.56 21­ Day Avg. 19.27 17.44 39.27 13.51 23.92 49.54 44.76 14.91 96­ Hour Avg. 20.99 19.34 43.50 14.94 26.59 56.35 51.03 16.36 Peak 21.77 19.95 44.78 15.43 27.36 58.47 52.93 16.92 Disulfoton Application Rate / Numberof Apps / Interval / Incorp. Depth / method 1 lb. ai/ A / # / days / inches 1.0 / 2/ 21/ 0/ f 0.83/ 2/ 21/ 0/ s ( granular) 1. 0 / 3/ 21/ 0/ s 4.0 / 2/ 14/ 2.5/ s 1.0/ 3/ 14/ 0/ f 4.0/ 1/ 0/ 2.5/ s ( granular) 4.0/ 1/ 0/ 2.5/ s 0.75/ 2/ 30/ 0/ f Crop Barley Barley Cotton Potatoes Potatoes Tobacco Tobacco Spr. Wheat 1 Method of application: f = foliar and s = soil 16 Surface Water Drinking Water Assessment with Index Reservoir and Percent Crop Area The estimated drinking water concentrations ( EDWCs) were evaluated using the methodology outlined in EPA­ OPP draft Guidance for Use of the Index Reservoir and Percent Crop Area Factor in Drinking Water Exposure Assessments ( USEPA, 2000) . This generally results in the modification of the scenarios developed for farm ponds to scenarios for the index reservoirs. The purpose the Index Reservoir ( IR) scenario and the Percent Crop Area ( PCA) for use in estimating the exposure in drinking water derived from vulnerable surface water supplies. Since the passage of the Food Quality Protection Act ( FQPA) in 1997, the Agency has been using the standard farm pond as an interim scenario for drinking water exposure and has been assuming that 100% of this small watershed is planted in a single crop. The Agency is now implementing the index reservoir to represent a watershed prone to generating high pesticide concentrations that is capable of supporting a drinking water facility in conjunction with the percent cropped area ( PCA) which accounts for the fact that a watershed large enough to support a drinking water facility will not usually be planted completely to a single crop. These two steps are intended to improve the quality and accuracy of the drinking water exposure for pesticides obtained by models. Percent Crop Area ( PCA) : PCA is a generic watershed­ based adjustment factor that will be applied to pesticide concentrations estimated for the surface water component of the drinking water exposure assessment using PRZM/ EXAMS with the index reservoir scenario. The output generated by the linked PRZM/ EXAMS models is multiplied by the maximum percent of crop area ( PCA) in any watershed ( expressed as a decimal) generated for the crop or crops of interest. Currently, OPP has PCA adjustments for four major crops corn, , cotton, soybeans, and wheat. Two are appropriate for disulfoton, cotton and wheat. The concept of a factor to adjust the concentrations reported from modeling to account for land use was first proposed in a presentation to the SAP in December 1997 ( Jones and Abel, 1997) . This guidance results from a May 1999 presentation to the FIFRA Scientific Advisory Panel ( SAP) , Proposed Methods For Determining Watershed­ derived Percent Crop Areas And Considerations For Applying Crop Area Adjustments to Surface Water Screening Models , and the response and recommendations from the panel. A more thorough discussion of this method and comparisons of monitoring and modeling results for selected pesticide/ crop/ site combinations is located at: http: / / www. epa. gov/ scipoly/ sap/ 1999/ may/ pca_ sap. pdf. The Agency will continue to develop PCAs for other major crops in the same manner as was described in the May 1999 SAP presentation. However, the Agency expects that it will use smaller watersheds for these calculations in the near future. For minor­ use crops, the SAP found that the use of PCAs produced less than satisfactory results and advised OPP to further investigate possible sources of error. Thus, for the near term, OPP is not be using PCAs in a crop­ specific manner for both major crops that do not yet have PCAs and minor­ use crops. Instead it will use a default PCA that reflects the total agricultural land in an 8­ digit Hydrologic Unit Code ( HUC) . The PCA values used in this assessment are listed in Appendix VII. 17 The OPP guidance document provides information on when and how to apply the PCA to model estimates, describes the methods used to derive the PCA, discusses some of the assumptions and limitations with the process, and spells out the next steps in expanding the PCA implementation beyond the initial crops. Instructions for using the index reservoir and PCA are provided below. Discussion on some of the assumptions and limitations for both the PCA and Index Reservoir are included in the Reporting section. One should note that there is an entry for All Agricultural Land in Appendix VII. . This is a default value to use for crops for which no specific PCA is available. It represents the largest amount of land in agricultural production in any 8­ digit hydrologic unit code ( HUC) watershed in the continental United States. The unadjusted EDWC ( PRZM/ EXAMS output) is multiplied by the appropriate PCA for that crop to obtain the final estimated drinking water concentration ( EDWC) . Note that if Tier 2 modeling is done for an area other than the standard scenario, the PCA would still be applied, since it represents the maximum percent crop area for that particular crop. ( As regional modeling efforts are expanded, regional PCAs could be developed in the future. ) As an example, for a pesticide used only on cotton, the PRZM/ EXAMS estimated environmental concentrations would be multiplied by 0.20. This factor would be applied to the standard PRZM/ EXAMS scenario for cotton or any non­ standard cotton scenario until such time as regional PCAs are developed. When multiple crops occur in the watershed, the co­ occurrence of these crops needs to be considered. The PCA approach assumes that the adjustment factor represents the maximum potential percentage of a watershed that could be planted to a crop. If, for example, a pesticide is only used on cotton, then the assumption that no more than 20% of the watershed ( at the current HUC scale used) would be planted to the crop is likely to hold true. The Index Reservoir ( IR) : IR is intended as a drop­ in replacement for the standard pond for use in drinking water exposure assessment. It is used in a manner similar to the standard pond, except that flow rates have been modified to reflect local weather conditions. The PRZM and EXAMS input files for the standard pond and index reservoir are in Appendix IX. This guidance results from a July, 1998 presentation to the FIFRA Science Advisory Panel. The materials for that presentation are at: http: / / www. epa. gov/ scipoly/ sap/ 1998/ index. htm Barley, cotton, potatoes, tobacco, and spring were considered because they represent significant uses, maximum application rates, and are grown in vulnerable regions of the United States. For the PRZM, the input files for each IR scenario are essentially the same as its farm pond scenario. Three parameters in the PRZM input file require modification, AFIELD, HL, and DRFT. These changes are shown in Appendix VIII. The estimated drinking water concentrations using the Index Reservoir ( IR) and PCA ( PCA) concepts for the same scenarios used for ecological exposure assessments were evaluated ( Tables 8a and 8b) . The long term mean of the parent disulfoton concentration in the Index Reservoir and by PCA ranged from 0.23 to 1.31 µ g/ L for cotton and tobacco, respectively. The 1­ in­ 10 year estimated annual mean concentration ranged from 0.43 to 2.77 µ g/ L for cotton and tobacco, respectively. The peak 1­ in­ 10 year estimated drinking water concentration for parent 18 disulfoton ranged from 7.13 to 44.20 µ g/ L. The Tier II modeling results from PRZM/ EXAMS fall within the range of concentrations for surface water reported in the STORET database ( 0.0 to 100 µ g/ L, 96 percent of 8137 samples were reported as less than 16 µ g/ L) , a Virginia monitoring study ( 0.37 to 6.11 µ g/ L) and NAWQA ( 0.010 to 0.060 µ g/ L) . But because some of the data in STORET have a high degree of uncertainty because many samples were only listed as actual value is known to less than given value , the maximum concentration of samples was not always known ( see Appendix III) . The modeled concentration estimates are generally greater than those seen in the monitoring data. The modeling results therefore cannot be confirmed by the monitoring data. Because the degradates of disulfoton ( including oxygen analogs) : sulfoxide and sulfone are also toxic, the EECs of the total disulfoton residue ( TDR) in the index reservoirs was also considered. The long term mean of the total disulfoton residues ( TDR) in the Index Reservoir and by PCA ranged from 2.55 to 10.42 µ g/ L for cotton and potatoes, respectively. The 1­ in­ 10 year estimated annual mean TDR concentrations in the IR ranged from 5.10 to 16.72 µ g/ L for cotton and potatoes, respectively. The peak 1­ in­ 10 year estimated TDR concentrations in the IR ranged from 20.83 to 104.92 µ g/ L. There are no monitoring data to evaluate these concentration estimates from PRZM/ EXAMS modeling. Uncertainty surrounds these estimates because the sites selected for modeling represent sites thought to be representative of vulnerable sites. Additionally, the IR was generic ( to each scenario) and data to fully understand of the fate of disulfoton and disulfoton residues is not available. Evidence suggests that the concentrations will not be as high as suggest by the modeled estimates. The PCA values have been estimated by OPP for spring wheat ( 0.56) and cotton ( 0.20) . The default for value for all agricultural land of 0.87 was used for the barley, potatoes, and tobacco scenarios. Better estimates of the PCA for these crops would reduce the uncertainty associated with the estimated drinking water concentrations. 19 Table 8a. Tier II Upper Tenth Percentile EECs for Disulfoton Parent Used on barley, cotton, potatoes, tobacco, and spring wheat for several application ( Label maximum) rates and management scenarios estimated using PRZM3/ EXAMS in Index Reservoir with Percent Crop Area. Mean of Annual Means ( µ g/ L) 0.95 0.51 0.23 1.05 0.94 1.31 0.86 0. 38 Concentration ( µ g/ L) ( 1­ in­ 10 annual yearly maximum value) Annual Avg. 1.61 1.22 0.43 1.30 1.09 2.77 2.38 0. 48 90­ Day Avg. 6.09 4.16 1.61 5.22 4.38 11.14 9.62 1. 79 60­ Day Avg. 7.69 5.59 2.32 7.53 6.19 16.23 14.09 2. 41 21­ Day Avg. 11.67 9.82 3.86 12.73 9.59 30.14 26.56 3. 88 96­ Hour Avg. 14.18 13.57 6.24 17.17 11.77 40.39 35.24 5. 76 Peak 15.51 14.88 7.13 18.83 13.09 44.20 38.57 6. 32 Disulfoton Application Rate / Number of Apps / Interval / Incorp. Depth / method 1 lb. ai/ A / # / days / inches 1.0 / 2/ 21/ 0/ f 0.83/ 2/ 21/ 0/ s ( granular) 1. 0 / 3/ 21/ 0/ s 4.0 / 2/ 14/ 2.5/ s 1.0/ 3/ 14/ 0/ f 4.0/ 1/ 0/ 2.5/ s ( granular) 4.0/ 1/ 0/ 2.5/ s 0.75/ 2/ 30/ 0/ f Crop 2 Barley Barley Cotton Potatoes Potatoes Tobacco Tobacco Spr. Wheat 1 Method of application: f = foliar and s = soil 2 PCA Barley, Potatoes, Tobacco = 0.87 ( default value for all ag. land) ; cotton = 0.20, Spring wheat = 0.56 20 Table 8b. Tier II Upper Tenth Percentile EECs for Total Disulfoton Residues Used on barley, cotton, potatoes, tobacco, and spring wheat for several application ( Label maximum) rates and management scenarios estimated using PRZM3/ EXAMS with Index Reservoir and Percent Crop Area. Mean of Annual Means ( µ g/ L) 4.21 5.42 2.55 10.42 9.49 8.70 8.01 3.68 Concentration ( µ g/ L) ( 1­ in­ 10 annual yearly maximum value) Annual Avg. 7.62 10.01 5.10 13.44 16.72 16.25 15.99 4.88 90­ Day Avg. 18.04 26.30 12.82 26.91 25.85 53.36 5347.00 11.03 60­ Day Avg. 22.33 27.99 14.10 30.06 27.87 66.65 63.97 12.24 21­ Day Avg. 29.47 32.50 17.91 32.41 30.21 85.43 85.04 13.84 96­ Hour Avg. 33.30 37.64 20.22 35.64 33.56 100.31 99.44 15.09 Peak 34.53 39.05 20.83 36.57 34.37 104.92 103.79 15.48 Disulfoton Application Rate / Numberof Apps / Interval / Incorp. Depth / method 1 lb. ai/ A / # / days / inches 1.0 / 2/ 21/ 0/ f 0.83/ 2/ 21/ 0/ s ( granular) 1. 0 / 3/ 21/ 0/ s 4.0 / 2/ 14/ 2.5/ s 1.0/ 3/ 14/ 0/ f 4.0/ 1/ 0/ 2.5/ s ( granular) 4.0/ 1/ 0/ 2.5/ s 0.75/ 2/ 30/ 0/ f Crop 2 Barley Barley Cotton Potatoes Potatoes Tobacco Tobacco Spr. Wheat 1 Method of application: f = foliar and s = soil 2 PCA values for Barley, Potatoes, Tobacco = 0.87 ( default value) ; cotton = 0.20, Spring wheat = 0.56 21 b. Ground water For this assessment, the maximum rate and number of disulfoton applications were used, while assuming conservative environmental properties ( 90 percent upper confidence bound on the mean aerobic soil half­ life of 6.12 days and an average Koc value of 551 mL/ g) . The maximum disulfoton concentration predicted in ground water by the SCI­ GROW model ( using the maximum rate 4 lb. a. i. / ac and 2 applications ­ potatoes) was 0.05 µ g/ L. The maximum total disulfoton residue concentration predicted in ground water by the SCI­ GROW model for the same scenario is 3.19 µ g/ L ( except 90 percent upper bound on mean half­ life of total residues is 259.6 days) . It should be noted that all the detections of disulfoton residues in ground water in Wisconsin ( range 4.0 to 100.0 µ g/ L) and some detections in Virginia ( range 0.04 ­ 2.87 µ g/ L) exceeded the concentrations predicted by SCI­ GROW ( 0.05 µ g/ L) . Although SCI­ GROW, which is thought to be conservative ( e. g. , a vulnerable site) , is based on a regression relationship between monitoring data ( detected concentrations) and pesticide fate chemistry at vulnerable sites, SCI ­ GROW does not account for preferential flow, point­ source contamination, pesticide spills, misuses, or pesticide storage sites. Many unknowns, data limitations, such as on­ site variability, are also present in the prospective ground­ water monitoring studies which were not included when developing SCI­ GROW. The difference between monitoring and modeling is discussed further in the next section. vi. Disulfoton Monitoring Data Ground Water: Monitoring Studies With No Disulfoton Residues Detections in Ground Water: The Pesticides in Ground Water Data Base ( USEPA, 1992) summarizes the results of a number of ground­ water monitoring studies conducted which included disulfoton ( and rarely the disulfoton degradates D. sulfone and D. sulfoxide) . Monitoring, with no detections ( limits of detections ranged from 0.01 to 6.0 µ g/ L) , has occurred in the following states ( number of wells) : AL ( 10) , CA ( 974) , GA ( 76) , HI ( 5) , IN ( 161) , ME ( 71) , MS ( 120) , MN ( 754) , OK ( 1) , OR ( 70) , and TX ( 188) . The range of detection limits, especially the high ones ( e. g. , 6 µ g/ L) reduce the certainty of these data. One hundred twenty wells were analyzed in MS for disulfoton degradates sulfone and sulfoxide and 188 wells were analyzed in TX for sulfone. Limits of detection were 3.80 and 1.90 µ g/ L for the sulfone and sulfoxide degrade, respectively, in MS. There were no degradates reported in these samples. North Carolina: The North Carolina Departments of Agriculture ( NCDA) and Environment, Health, and Natural Resources ( DEHNR) conducted a cooperative study under the direction of the North Carolina Pesticide Board ( NCIWP, 1997) . The purpose of the statewide study was to determine if the labeled uses of pesticide products were impacting the ground water resources in North Carolina. The study was conducted in two phases. In phase one, 55 wells in the DEHNR Ground Water 22 Section' s ambient monitoring network representing the major drinking water aquifers of the state were sampled at least twice and analyzed for selected pesticides. In phase two, 97 cooperator monitoring wells were installed and subsequently sampled at least twice in 36 counties across the North Carolina. Sites for the cooperator monitoring wells were chosen based on an evaluation of the vulnerability of ground water to risk of contamination from the use of pesticides. Monitoring wells were located adjacent to and down­ gradient from areas where pesticides were reported to have been applied ( within 300 feet) during the previous five years. Wells were constructed so that the shallowest ground water could be collected for analysis. The objective of these criteria was to use a scientific method for determining monitoring well locations so that the results could be used as an early indication of the potential for problems associated with pesticides leaching to ground water. Disulfoton residues were monitored for in five North Carolina counties, Alleghany, Ash, Beaufort, Madison, and Robeson. Seven wells were located in Christmas Tree growing areas, one in wheat growing county, and two in tobacco areas. The study authors make the following statement, " Results cannot be interpreted as representing the quality of ground water near pesticide use areas statewide because the study methods targeted areas of highly vulnerable ground water" . There were no detections of disulfoton, disulfoton sulfoxide, and disulfoton in the ground­ water monitoring study conducted in North Carolina. Efforts were made to place the wells in vulnerable areas where the pesticide use was known, so that the pesticide analyzed for would reflect the use history around the well. Limitations of the study include that sites were sampled only twice and the limits of detections were high ( e. g. , > 1.0 µ g/ L) for some of disulfoton analytes. Uncertainties associated with the study include whether two samples from eight wells are adequate to represent the ground­ water concentrations of disulfoton residues, did DRASTIC correctly identify a site' s vulnerability, and were the wells placed down­ gradient of the use areas. The study used tools and information available at the time of the study to identify vulnerable locations for well placement. This included statewide agricultural data from the N. C. Agricultural Statistics which were used to identify crop growing areas, the USEPA DRASTIC method ( Aller et al. , 1987) was used to locate the most vulnerable locations in the target crop growing areas, and local county agents of the USDA Natural Resources Conservation Service ( NRCS) helped identify cooperators­ farmers for placement of wells. The Pesticide Study staff and county agents also met with the cooperators to obtain pesticide use information. Other studies have shown that DRASTIC is not as good a method to identify vulnerable areas as hoped. The study appeared to QA/ QC practices. Monitoring Studies With Disulfoton Detections in Ground Water: Two of the studies cited in the PGWDB ( USEPA, 1992) report the detection of disulfoton residues in ground water. The disulfoton detections in ground water in occurred studies conducted by Virginia Polytechnic Institute and State University ( VPI& SU, Mosaghimi, 1989) in Virginia where disulfoton concentrations ranged from 0.04 to 2.87 µ g/ L and in a Wisconsin Department of Natural Resources study in Wisconsin ( WDNR, after Barton, 1982) where concentrations ranged from 4.00 to 100.00 µ g/ L. Of specific are the disulfoton concentrations of parent disulfoton reported in these studies ( VA and WI) that exceeded the estimate of 0.05 µ g/ L obtained from EFED' s 23 SCI­ GROW ( ground­ water screening model) model. Virginia: A monitoring study was conducted to evaluate the effectiveness of Best Management Practices ( BMP) in a 3616­ acre watershed in the Nomini Creek Watershed, Westmoreland County, Virginia. Approximately half of the watershed is in agriculture and the other half is forested. The major focus of this study was surface­ water quality rather than ground­ water quality. However, in addition to the surface­ water monitoring, twelve wells were analyzed for pesticides, including disulfoton. Samples were taken in 1985 and 1986 from four household wells in the Nomini Creek Watershed ( NCW) . Water samples from these wells were analyzed for 24 pesticides. Detectable levels of ( not specified) pesticides were found in all four wells at concentrations below the respective MCL. One of these four household wells consistently had higher pesticide levels than the other wells. The study authors suggested that this household well was not " sufficiently protected and was contaminated by surface runoff from adjacent land" . Based upon these results of the four household wells sampled, eight pairs of ground­ water monitoring wells ( 39 to 54 feet deep) were installed at eight sites in the NCW and sampled approximately monthly from June 1986 through December 1990. Information concerning farming practices in the watershed was obtained from farmer interviews and questionnaires. Disulfoton residues ( 0.04, 0.10, 0.10, 0.13, 0.16, and 2.87 µ g/ L) were detected in wells at five of the eight monitoring sites during the period 11/ 86 to 12/ 90. The average detection was 0.57 µ g/ L ( standard deviation = 1.13 µ g/ L) . Since the study authors present no information or discussion questioning the pesticide detections which occurred in the monitoring wells ( notably site GN3, the well with 2.87 µ g/ L) , the disulfoton detections found in the monitoring wells should be included in this assessment. Table 9. Summary of Disulfoton Detections in ground water from the eight ground­ water monitoring wells in Nomini Creek Watershed ( Virginia) , during 1986 and 1987. Sampling Date Well­ Site Number Concentration ( g/ L) 11/ 5/ 86 GN3 2.87 11/ 5/ 86 GN6 0.04 3/ 13/ 87 GN4 0.10 8/ 20/ 87 GN1 0.13 8/ 20/ 87 GN2 0.16 8/ 20/ 87 GN3 0.10 24 The study was conducted under a Quality Assurance/ Quality Control Plan. Pesticides were determined using GLC methods with an EC Ni63 detector. The study reportedly ran until 1995 ( data available only goes through 1990) . Wisconsin: Barton, 1982. In May and June 1982, the Wisconsin Department of Natural Resources ( WDNR) sent twenty­ nine water samples from wells in the Central Sands area of Wisconsin to the EPA' s Office of Pesticide Programs for pesticide residue analysis. Samples were taken from one municipal well, two or three community wells, and twenty­ five home wells; all of which were sources of drinking water. Of the 29 samples, 15 samples were reported as no detects whereas 14 samples were reported disulfoton detections. Disulfoton detections ranged from 4.00 to 100.00 µ g/ L, with a mean ( samples with detections) of 38.43 µ g/ L and standard deviation of 31.56 µ g/ L. No detection limit was specified for disulfoton, although detections as low as 1 µ g/ L are reported for other pesticide residues ( aldicarb, and aldicarb sulfone, dinoseb, sencor, linuron, carbofuran, and Lasso/ Bravo) . Holden ( 1986) wrote that the WDNR sampling program was criticized for a number of reasons including that the quality assurance and quality control procedures ( QA/ QC) were not always followed during some stages of sampling and analysis ( Holden, 1986) . Holden ( 1986) further indicates that " Harkin et al. ( 1984) noted in their WIS WRC report Pesticides in Groundwater beneath the Central Sand Plain of Wisconsin that some detections of pesticides in initial screening were false positives and were not supported by resampling and reanalysis by more sensitive analytical methods. " Aldicarb and aldicarb sulfone were also found in this study and in follow up studies, while disulfoton was apparently not found in follow­ up sampling. Aldicarb is no longer registered for use in Wisconsin. The criticisms of the WDNR study must, however, be put in some sort of perspective. First, a study that did not follow QA/ QC criteria does not and should not automatically mean that the data is bad or wrong, the detections may be correct ( presence and magnitude) . Frequently " older" monitoring studies often had problems associated with them, such as QA/ QC problems, limited pesticide usage information, and no knowledge about the study area' s hydrology. Frequently, studies with QA/ QC programs are poorly designed, so that the results may be meaningless. Pesticide residues not being found in follow­ up sampling may be the result of dissipation processes and should not be used to discount detections in earlier samples. The environmental fate properties and site hydrology must also be considered. Because ground water is a dynamic system, pesticides may be present at one sampling event and not at another. So when the sample is collected, in relationship to pesticide use and rainfall, is important. All that can be said is that residues were not found in follow­ up samples. It is unknown which samples were re­ analyzed with more sensitive methods. The disulfoton detections in the Central Sand Plain may have been the result of preferential flow and transport processes. Literature documents preferential flow in the Central Sand Plain. Thus, 25 disulfoton residues may have by­ passed the soil matrix and gone directly to ground water which is possibly reflected in the " high" level of the detections. Although preferential flow is currently an ongoing area of research and much remains unknown, it is known that preferential flow is influenced by a number of factors, including rainfall amounts, intensity, and frequency. Disulfoton generally appears to be not very persistent under aerobic soil conditions and therefore may also not be very persistent in aquifers that are aerobic. Therefore it may have also been missed by utilizing a predetermined sampling schedule ( e. g. , monthly) . Whereas a persistent chemical, such as aldicarb and aldicarb sulfone, will be found at greater frequencies and be less dependent upon timing of sampling. Disulfoton usage history before the detections and prior to the follow­ up sampling is not specified. Surface Water: A monitoring study was conducted to evaluate the effectiveness of Best Management Practices ( BMP) in a 3616­ acre watershed in the Nomini Creek Watershed, Westmoreland County, Virginia. Approximately half of the watershed is in agriculture and the other half is forested. The major focus of this study was surface­ water quality rather than ground­ water quality. The detections of parent disulfoton in surface­ water samples ( 0.037 to 6.11 µ g/ L) collected ( Table 10) in the Nomini Creek Watershed study fell within an order of magnitude with the estimated environmental concentrations ( EECs) obtained from the PRZM/ EXAMS models for parent disulfoton which range from 0.21 to 1.14 µ g/ L for annual mean daily concentrations and 7.14 to 26.75 µ g/ L for peak daily values. Table 10. Disulfoton detections in Surface Water samples collected in the Nomini Creek Watershed ( Virginia) , during 1986. Sample date Site Number: Sample # Concentration ( g/ L) 8/ 18/ 86 QN1: 1 ( 9: 13 am) 6.11 8/ 18/ 86 QN1: 2 ( 12: 25 pm) 0.37 9/ 28/ 86 QN2: ( only 1 sample) 1.62 NAWQA : Disulfoton residues have been detected in surface water at a low frequency in the USGS NAWQA study. The percentage of detections with disulfoton concentrations > 0.01 µ g/ L for all samples, agricultural streams, urban streams were 0.27% , 0.20, and 0.61% , respectively. The corresponding maximum concentrations were 0.060, 0.035, and 0.037 µ g/ L. Disulfoton has not been detected in ground water in the NAWQA study. Although pesticide usage data is collected for the different NAWQA study units, the studies are not targeted, specifically for disulfoton. 26 STORET : About 50 percent of the well samples reported in STORET had low levels ( < 1 µ g/ L) of disulfoton residues. However, there were indications of some high concentrations ( the other 50% were reported as < 250 µ g/ L) , which may be a reflection of how the data were reported as the disulfoton concentrations in the monitoring were not always known. This is because the detection limit was extremely high or not specified, and/ or the limit of quantification was not stated or extremely high. Disulfoton concentrations were simply given as less than a value. Therefore, considerable uncertainty exists with respect to the STORET monitoring data. Limitations of Monitoring Data The interpretation of the monitoring data is limited by the lack of correlation between sampling dates and the use patterns of the pesticide within the study s drainage basin. Additionally, the sample locations were not associated with actual drinking water intakes for surface water nor were the monitored wells associated with known ground water drinking water sources. Also, due to many different analytical detection limits, no specified detection limits, or extremely high detection limits, a detailed interpretation of the monitoring data is not always possible. Limitations for the monitoring studies include the use of different limits of detection between studies, lack of information concerning disulfoton use around sampling sites, and lack of data concerning the hydro geology of the study sites. The spatial and temporal relationship between disulfoton use, rainfall/ runoff events and the location and time of sampling cannot often be adequately determined. Thus, it is not always possible to judge the significance of the level or the lack of detections. Although no assessment can be made for degradates due to lack of data, limited data suggests that the degradates are more persistent ( > 200 days) than disulfoton, suggesting their presence in water for a longer period of time than the parent. The degradates also appear to be more mobile than the parent compound. vii. Limitations of this Modeling Analysis There are number of factors which limit the accuracy and precision of this modeling analysis including the selection of the high­ end exposure scenarios and maximum number of applications and rates, the quality of the data, the ability of the model to represent the real world, and the number of years that were modeled. There are additional limitations on the use of these numbers as an estimate of drinking water exposure. Individual degradation/ metabolism products were also not considered due to lack of data. Another major uncertainty in the current EXAMS simulations is that the aquatic degradation rate used an estimated rate due to lack of data. Direct aquatic photolysis was also included. The total disulfoton residue decline rate was estimated from data, but Kocs and hydrolysis rates for D. sulfoxide and sulfone were not known and assumed to be equal to those of parent disulfoton. These limitations influence the estimates of pesticides transported off the field ( loading files) to the pond, plus the degradation once in the pond. Spray is determined by method of pesticide application, and is assumed to be 0% percent when applied as broadcast ( granular) or in­ furrow, 5% for ground spray, and 15% for aerial spray for 27 the farm pond, and 6.4% ground and 16.4% aerial spray for the Index Reservoir scenario ( Jones et al. , 2000) . Tier II scenarios are also ones that are likely to produce high concentrations in aquatic environments. The scenarios were intended to represent sites that actually exist and are likely to be treated with a pesticide. These sites should be extreme enough to provide a conservative estimates of the EEC, but not so extreme that the model cannot properly simulate the fate and transport processes at the site. The EECs in this analysis are accurate only to the extent that the sites represent the hypothetical high exposure sites. The most limiting aspect of the site selection is the use of the standard pond which has no outlet. . It also should be noted that the standard pond scenario used here would be expected to generate higher EECs than most water bodies, although, some water bodies would likely have higher concentrations ( e. g. , a shallow water bodies near agriculture fields that receive direct run­ off from the treated field) . The quality of the analysis is also directly related to the quality of the chemical and fate parameters available for disulfoton. Acceptable data are available, but rather limited. Data were not available for degradates and the aquatic aerobic metabolism rate was not known, but estimated. Degradates with greater persistence and greater mobility would be expected to have a higher likelihood of leaching to ground water, with greater concentrations in surface water. The measured aerobic soil metabolism data is limited, but has sufficient sample size to establish an upper 90% confidence bound on the mean of half­ lives for the three aerobic soils tested in the laboratory ( and submitted to EFED) and reported in the EFED One­ liner Database ( MRIDs 40042201, 41585101, 43800101) . The use of the 90% ­ upper bound value may be sufficient to capture the probable estimated environmental concentration when limited data are available. PRZM assumes pesticide decline follows first­ order kinetics. As discussed in the aerobic soil metabolism section, disulfoton doesn' t entirely follow first­ order kinetics. The models themselves represent a limitation on the analysis quality. These models were not specifically developed to estimate environmental exposure in drinking water so they may have limitations in their ability to estimate drinking water concentrations. Aerial spray drift reaching the pond is estimated from Spray Drift Task Force ( SDTF) preliminary data to be 15 percent of the application rate and for ground spray it is 1 percent of the application rate. No drift was assumed for broadcast or in­ furrow applications. Another limitation is the lack of field data to validate the predicted pesticide run­ off. Although, several of the algorithms ( volume of run­ off water, eroded sediment mass) are somewhat validated and understood, the estimates of pesticide transport by PRZM3 has not yet been fully validated Other limitations of PRZM are the inability to handle within site variation ( spatial variability) , crop growth, and the overly simple water balance. Another limitation is that 20 to 40 years of weather data were available for the analysis. Consequently there is a 1 in 20, 27, 36, or 40 chance that the true 10% exceedence EECs are larger than the maximum EEC in the analysis. If the number of years of weather data were increased, it would increase the level of confidence that the estimated value for the 10% exceedence EEC was close to the true value. EXAMS is primarily limited because it is a steady­ state model and cannot accurately characterize the dynamic nature of water flow. A model with dynamic hydrology would more 28 accurately reflect concentration changes due pond overflow and evaporation. Thus, the estimates derived from the current model simulates a pond having no­ outlets, flowing water, or turnover. Another major limitation in the current EXAMS simulations is that the aquatic ( microbial) and abiotic degradation pathways were adequately considered. The binding potential of the degradates is not known and was not considered. Another important limitation of the Tier II EECs for drinking water exposure estimates is the use of a single 10­ hectare drainage basin with a 1­ hectare pond. It is unlikely that this small system accurately represents the dynamics in a watershed large enough to support a drinking water utility. It is unlikely that an entire basin, with an adequate size to support a drinking water utility would be planted completely in a single crop or be represented by scenario being modeled. The pesticides would more likely be applied over several days to weeks rather than on a single day. This would reduce the magnitude of the conservative concentration peaks, but also make them broader, reducing the acute exposure, but perhaps increasing the chronic exposure. 3. Ecological Effects Hazard Assessment A. Toxicity to Terrestrial Animals i. Birds, Acute and Subacute An acute oral toxicity study using the technical grade of the active ingredient is required to establish the toxicity of a pesticide to birds. The preferred test species is either mallard duck or bobwhite quail. Results of this test are tabulated below. Acute oral testing was also performed with the 15G formulation of disulfoton. Additionally, acute oral testing was required for the two major degradation products of disulfoton, disulfoton sulfone and disulfoton sulfoxide, due to their relative persistence. These test results are as follows: 29 Table 11. Avian Acute Oral Toxicity Species % ai LD50 ( mg/ kg) Toxicity Category MRID No. Author/ Year Study Classification Mallard ( Anas platyrhynchos) 97 6.54 very highly toxic 00160000 1984/ Hudson supplemental Northern bobwhite quail ( Colinus virginianus) technical 12.0 highly toxic EDODIS00 Hill core Northern bobwhite quail ( Colinus virginianus technical 28 highly toxic 0095655 1977 core Northern bobwhite quail ( Colinus virginianus) technical 31 highly toxic 0095655 1977 core Northern bobwhite quail ( Colinus virginianus) 98.7 39 highly toxic 42585803 / 1992 core Ring­ necked pheasant ( Phasianus colchicus) technical 11.9 highly toxic 00160000 1987/ Hudson core Red­ winged blackbird ( Agelaius phoeniceus ) technical 3.2 very highly toxic 1987 supplemental Northern bobwhite quail ( Colinus virginianus) 15G 220 moderately toxic 25525 1969 core Northern bobwhite quail ( Colinus virginianus) 15G 97 moderately toxic 25525 1969 core Northern bobwhite quail ( Colinus virginianus) 15G 14.5 highly toxic 0095655 1984 supplemental Northern bobwhite quail ( Colinus virginianus) 15G 29 highly toxic EDODIS00 1984 supplemental Northern bobwhite quail ( Colinus virginianus) sulfone metabolite 87.4 18 highly toxic 42585103 1992 core Northern bobwhite quail ( Colinus virginianus) sulfoxide metabolite 85.3 9.2 very highly toxic 42585102 1992 core 30 These results indicate that disulfoton is highly toxic to very highly toxic to avian species on an acute oral basis. The guideline requirement ( 71­ 1) is fulfilled ( MRID # 42585803) . Additionally, the two major metabolites of disulfoton, disulfoton sulfone and disulfoton sulfoxide, are highly toxic and very highly toxic, respectively. Guideline 71­ 1 is fulfilled for the two major degradates of disulfoton ( 42585103 and 42585102) . Two subacute dietary studies using the technical grade of the active ingredient are required to establish the toxicity of a pesticide to birds. The preferred test species are mallard duck ( a waterfowl) and bobwhite quail ( an upland gamebird) . Subacute dietary testing on the two major metabolites of disulfoton, disulfoton sulfone and disulfoton sulfoxide, were also required, due to the relative persistence of these degradates. Results of all avian subacute dietary tests are as follows: Table 12. Avian Subacute Dietary Toxicity Species % ai LC50 ( ppm) Toxicity Category MRID No. Author/ Year Study Classification Northern bobwhite quail ( Colinus virginianus) technical 544 moderately toxic 0094233 Lamb/ 1973 core Mallard duck ( Anas platyrhynchos) technical 510 moderately toxic 0034769 Hill/ 1975 core Japanese quail ( Coturnix japonica) technical 333 highly toxic 0034769 Hill/ 1975 supplemental Mallard duck ( Anas platyrhynchos) sulfone metabolite 87.4 622 moderately toxic 42585101 1992 core Northern bobwhite quail ( Colinus virginianus) sulfone metabolite 87.4 558 moderately toxic 42585106 1992 core Mallard duck ( Anas platyrhynchos) sulfoxide metabolite 85.3 823 moderately toxic 42585104 1992 core Northern bobwhite quail ( Colinus virginianus) sulfoxide metabolite 85.3 456 highly toxic 42585105 1992 core These results indicate that disulfoton is highly toxic to avian species on a subacute dietary basis. The guideline requirement ( 71­ 2) is fulfilled ( ACC # 0094233 and 0034769) . Additionally, the major metabolites of disulfoton, disulfoton sulfone and disulfoton sulfoxide, are moderately to highly toxic to avian species on a dietary basis. Guideline 71­ 2 is fulfilled for both metabolites ( MRID # 42585101, 42585106, 42585104, and 42585105) . 31 ii. Birds, Chronic Avian reproduction studies using the technical grade of the active ingredient are required for disulfoton because the following conditions are met: ( 1) birds may be subject to repeated or continuous exposure to the pesticide, especially preceding or during the breeding season, ( 2) the pesticide is stored or accumulated in plant or animal tissues, and/ or, ( 4) information derived from mammalian reproduction studies indicates reproduction in terrestrial vertebrates may be adversely affected by the anticipated use of the product. Disulfoton meets all of these conditions. The preferred test species are mallard duck and bobwhite quail. Results of these tests are tabulated below. Table 13. Avian Reproductive Toxicity Species % ai NOAEC/ LOAEC ( ppm) Endpoints Affected MRID No. Author/ Year Study Classification Northern bobwhite quail ( Colinus virginianus) 98.7 37/ 74 hatchling body weight 43032501 / 1993 core Mallard duck ( Anas platyrhynchos) 98.3 37/ 80 adult and hatchling body weight 43032502 / 1993 core There was a statistically significant reduction in hatchling body weight at 74 ppm in the bobwhite quail study; however, there were no significant differences in hatchling body weights by day 14 post­ hatch. No other effects were observed in this study. Adult and hatchling body weights were significantly reduced at 80 and 164 ppm in the mallard study, and body weight gain in adults was significantly reduced throughout the study at these two treatment levels as well. Other effects observed at the 164 ppm level were: significantly fewer eggs laid per hen, reduced eggshell strength and thickness, reduced number of hatchlings as a percent of viable embryos, reduced number of 14­ day survivors as a percent of normal hatchlings, reduced viable embryos as a percent of eggs set, and reduced 14­ day survivors as a percentage of eggs set. The guideline requirement for avian reproduction testing ( 71­ 4) is fulfilled ( MRID # 43032501, and 43032502) . iii. Mammals, Acute and Chronic Wild mammal testing is required on a case­ by­ case basis, depending on the results of lower tier laboratory mammalian studies, intended use pattern and pertinent environmental fate characteristics. In most cases, rat or mouse toxicity values obtained from the Agency' s Health Effects Division ( HED) substitute for wild mammal testing. These toxicity values are reported in the Table below. 32 Table 14. Mammalian Acute Toxicity Species % ai Test Type Toxicity Values/ category MRID No. Mule deer ( Odocoileus hemionus ) Domestic goat ( Capra hircus ) Laboratory rat ( Rattus norvegicus) 97 97 94.4 acute oral acute oral acute oral 2.5 mg/ kg very highly toxic < 15 mg/ kg very highly toxic 1.9 mg/ kg females I 6.2 mg/ kg males I 00160000 00160000 072293 Laboratory mouse ( Mus musculus) 94.4 acute oral 8.2 mg/ kg ( female) I 7.0 mg/ kg ( male) I 072293 Laboratory rat ( Rattus norvegicus) sulfone metabolite acute oral 11.24 mg/ kg ( female) I 0071873 Test results indicate that disulfoton is very highly toxic ( Category I) to small mammals on an acute oral basis. Testing on the sulfone metabolite also indicates very high acute oral toxicity. Table 15. Mammalian Chronic Toxicity Species % ai Test Type Toxicity Values/ category MRID No. Laboratory rat ( Rattus norvegicus) 97.8 2­ generation reproduction maternal NOAEC= 2.4 ppm/ LOAEC= 7.2 ppm repro NOAEC= 0.8 ppm/ LOAEC= 2.4 ppm 261990 The two­ generation rat reproduction study provided a reproductive NOEC level of 0.8 ppm. Parameters affected in the study included decreased litter size, lowered pup survival, and decreased pup weight. iv. Insects A honey bee acute contact study using the technical grade of the active ingredient is required for disulfoton because its use may result in honey bee exposure. Results of this test are as follows: 33 Table 16. Nontarget Insect Acute Contact Toxicity Species % ai LD50 ( F g/ bee) Toxicity Category MRID No. Author/ Year Study Classification Honey bee ( Apis mellifera ) technical 4.1 moderately toxic 05004151 1968 core Honey bee ( Apis mellifera) sulfone metabolite 91.6 0.96 highly toxic 42582902 1992 core Honey bee ( Apis mellifera) sulfoxide metabolite 85.3 1.11 moderately toxic 42582901 1992 core The results indicate that disulfoton is moderately toxic to bees and disulfoton sulfone, and disulfoton sulfoxide are very highly toxic to bees on an acute contact basis. The guideline requirement ( 141­ 1) is fulfilled for parent disulfoton ( MRID # 05004151) , as well as for the two major metabolites ( MRID # 42582902, 42582901) . A honey bee toxicity of residues on foliage study using the typical end­ use product was submitted for disulfoton. The results of this study are tabulated below. Table 17. Nontarget Insect Toxicity of Residues on Foliage Species Formulatio n LD50 ( lb. / A) Toxicity Category MRID or ACC # Author/ year Guideline Classification Honey bee ( Apis mellifera 8 E. C. > 1.0 0163423 core The results indicate that disulfoton residues on foliage are not toxic to honey bees at application rates up to 1.0 lb / A. Guideline 141­ 2 is fulfilled for disulfoton ( ACC # 0163423) . v. Terrestrial Field Testing Terrestrial field testing was conducted for disulfoton because of the high toxicity of the chemical in relation to expected environmental concentrations. Three field studies were originally required in the 1985 Registration Standard, but only one screening level field study and one residue monitoring study were submitted. The Level I ( screening) field study was conducted on potatoes in Benton county, Washington, using the 15G formulation ( MRID # 410560­ 01) . The study did show mortality to wildlife from the use of the 15G formulation on potatoes; since it was a screening study, there were no further conclusions. If no mortality had been observed, the study would not have been classified as core as the study design and carcass searching techniques were insufficient to negate the presumption of risk. The study fulfilled Guideline 71­ 34 5 only because adverse effects were seen. The fact that bird and mammal carcasses were found even with such an insensitive study design emphasizes the high acute risk this chemical poses to terrestrial vertebrates. The residue monitoring study ( MRID # 412018­ 01) was conducted with Di­ Syston 8 ( foliar) on potatoes in Michigan. Disulfoton was aerially applied to potatoes 3 times at 1 lb ai/ acre in Michigan. The results of this study indicated that there was hazard to terrestrial wildlife from the foliar application of disulfoton, and also suggested that a full Level 1 field study was needed with the foliar application. An second residue monitoring study ( MRID # 411189­ 01) was performed, in which disulfoton was soil incorporated by ground equipment, ( initially in furrow at planting at 3 lb ai/ acre and 6 ­ 7 weeks later as a side dressing at 3 lbs ai/ acre) . Although the residues on vegetation were much lower in this second study as compared to the first, nevertheless they posed potential acute and chronic risk especially to small mammals. B. Toxicity to Freshwater Aquatic Animals i. Freshwater Fish, Acute Two freshwater fish toxicity studies using the technical grade of the active ingredient are required to establish the toxicity of a pesticide to fish. The preferred test species are rainbow trout ( a Coldwater fish) and bluegill sunfish ( a warmwater fish) . Results of these tests are as follows: 35 Table 18. Freshwater Fish Acute Toxicity Species % ai LC50 ( ppb ai) Toxicity Category MRID No. Author/ Year Study Classification Rainbow trout ( Oncorhynchus mykiss) 98 tech 15G 65EC sulfone metabolite sulfoxide metabolite 1,850 3,000 13,900 3,500 > 9,200 60,300 moderately toxic moderately toxic slightly toxic moderately toxic moderately toxic slightly toxic 40098001 F. L. Mayer/ 1986 0068268 Lamb/ 1972 0068268 Lamb/ 1972 0068268 Lamb/ 1972 42585111 Gagliano/ 1992 42585110 Gagliano/ 1992 core core core core core core Bluegill sunfish ( Lepomis macrochirus 98.0 Tech 15G 65EC 20E sulfone metabolite sulfoxide metabolite 300 39 250 59 8.2 112 188 highly toxic very highly toxic highly toxic very highly toxic very highly toxic highly toxic highly toxic 40098001 F. L. Mayer/ 1986 0068268 Lamb/ 1972 0068268 Lamb/ 1972 0068268 Lamb/ 1972 229299 1962 42585108 Gagliano/ 1992 42585107 Gagliano/ 1992 core core core core supplemental core core Channel catfish ( Ictalurus punctatus ) 98.0 4, 700 moderately toxic 40098001 Mayer/ 1986 core Goldfish ( Carassius auratus ) 90 7,200 moderately toxic 229299 1962 supplemental Largemouth bass ( Micropterus salmoides ) 98.0 60 very highly toxic 40098001 Mayer/ 1986 core Fathead minnow ( Pimphales promelas ) 98.0 4, 300 moderately toxic 40098001 Mayer/ 1986 core Guppy 90 280 highly toxic 229299 supplemental 36 These results indicate that parent disulfoton is very highly toxic to slightly toxic to freshwater fish on an acute basis. The two major metabolites, disulfoton sulfone and disulfoton sulfoxide, are highly toxic to slightly toxic to freshwater fish on an acute basis. The rainbow trout, a Coldwater species, appears to be somewhat less sensitive than the warmwater species to disulfoton and its metabolites. The guideline requirement ( 72­ 1) is fulfilled for parent disulfoton, disulfoton sulfone, and disulfoton sulfoxide. ii. Freshwater Fish, Chronic A freshwater fish early life­ stage test using the technical grade of the active ingredient is required for a pesticide when it may be applied directly to water or if the end­ use product is expected to be transported to water from the intended use site, and the following conditions are met: ( 1) the pesticide is intended for use such that its presence in water is likely to be continuous or recurrent regardless of toxicity, ( 2) any aquatic acute LC50 or EC50 is less than 1 mg/ l, ( 3) the EEC in water is equal to or greater than 0.01 of any acute LC50 or EC50 value, or, ( 4) the actual or estimated environmental concentration in water resulting from use is less than 0.01 of any acute LC50 or EC50 value and any one of the following conditions exist: studies of other organisms indicate the reproductive physiology of fish may be affected, physicochemical properties indicate cumulative effects, or the pesticide is persistent in water ( e. g. , half­ life greater than 4 days) . The preferred test species is rainbow trout, but other species may be used. . Freshwater fish early life­ stage testing was required for disulfoton due to the likelihood of drift and runoff from the application sites, the likelihood of repeated or continuous exposure from multiple applications, and the high acute toxicity to several species of freshwater fish. Results of this test are tabulated below. Table 19. Freshwater Fish Early Life­ Stage Toxicity Species % ai NOAEC/ LOAEC ( ppb ai) MATC ( ppb) Endpoints Affected MRID No. Author/ Year Study Classification Rainbow trout ( Oncorhynchus mykiss) 98 220/ 420 300 growth 41935801 1991 core The guideline requirement ( 72­ 4a) is fulfilled ( MRID 41935801) . A freshwater fish life­ cycle test using the technical grade of the active ingredient is not required for disulfoton. A marine/ estuarine fish life­ cycle test was conducted with disulfoton, since the marine/ estuarine species is more sensitive than the freshwater species. This is discussed in section c ii , below. iii. Freshwater Invertebrates, Acute A freshwater aquatic invertebrate toxicity test using the technical grade of the active ingredient 37 is required to establish the toxicity of a pesticide to invertebrates. The preferred test species is Daphnia magna . Results of this test are tabulated below. Table 20. Freshwater Invertebrate Toxicity Species % ai LC50/ EC50 ( ppb ai) Toxicity Category MRID No. Author/ Year Study Classification Waterflea ( Daphnia magna) Waterflea ( Daphnia magna) Waterflea ( Daphnia magna 98.6 Sulfone metabolite 87.4 sulfoxide metabolite 85.3 13.0 35.2 64 very highly toxic very highly toxic very highly toxic 00143401 Heimbach/ 1985 42585112 Gaglaino/ 1992 42585109 Gagliano/ 1992 core core core Scud ( Gammarus fasciatus ) 98 technical 52 27 very highly toxic very highly toxic 40098001 Mayer/ 1986 05017538 1972 supplemental supplemental Glass shrimp ( Palaemonetes kadiakensis ) 98 3.9 very highly toxic 40094602 1980 supplemental Stonefly ( Acroneuria pacifica ) 89 < 8.2 very highly toxic 229299 1962 supplemental Stonefly ( Pteronarcys californica ) 98 5.0 very highly toxic 40098001 Mayer/ 1986 core The results indicate that disulfoton and its metabolites, disulfoton sulfone and disulfoton sulfoxide, are very highly toxic to aquatic invertebrates on an acute basis. The guideline requirement ( 72­ 2) is fulfilled. iv. Freshwater Invertebrate, Chronic A freshwater aquatic invertebrate life­ cycle test using the technical grade of the active ingredient is required for a pesticide if the end­ use product may be applied directly to water or expected to be transported to water from the intended use site, and the following conditions are met: ( 1) the pesticide is intended for use such that its presence in water is likely to be continuous or recurrent regardless of toxicity, ( 2) any aquatic acute LC50 or EC50 is less than 1 mg/ l, or, ( 3) the EEC in water is equal to or greater than 0.01 of any acute EC50 or LC50 value, or, ( 4) the actual or estimated environmental concentration in water resulting from use is less than 0.01 of any aquatic acute EC50 or LC50 value and any of the following conditions exist: studies of other 38 organisms indicate the reproductive physiology of invertebrates may be affected, physicochemical properties indicate cumulative effects, or the pesticide is persistent in water ( e. g. , half­ life greater than 4 days) . The preferred test species is Daphnia magna . Freshwater aquatic invertebrate life­ cycle testing was required for disulfoton. Results of this test are tabulated below. Table 21. Freshwater Aquatic Invertebrate Life­ Cycle Toxicity Species % ai NOAEC/ LOAE C ( ppb) MATC ( ppb) Endpoints Affected MRID No. Author/ Year Study Classifica tion Waterflea ( Daphnia magna) 98 0.037/ 0.070 0.051 survival, length, and # young/ adult 41935802 Blakemore/ 1991 core Waterflea ( Daphnia magna) 99.3 Sulfone 0.14/ 0.27 0.19 length 43738001 Bowers/ 1995 core Waterflea ( Daphnia magna) 98.9 Sulfoxide 1.53/ 2.97 2.13 Weight & length 43738002 Bowers/ 1995 core The guideline requirement ( 72­ 4) is fulfilled ( MRID # 41935802) . v. Freshwater Field Studies A microcosm study was conducted to evaluate the effects of runoff of disulfoton on a simulated aquatic field system ( MRID # 435685­ 01/ Cook and Kennedy, 1994) . Three dose levels ­ ­ 3, 10, 30 ppb ­ ­ were established in two replicate tanks per dose. Each tank was dosed 4 times at 7 day intervals. The study demonstrated that 3 ppb is the maximum acceptable toxicant concentration ( MATC) for this chemical in aquatic systems. At treatment levels of 3 ppb and higher, adverse effects were seen on zooplankton numbers, zooplankton community similarity, adult macro invertebrate population numbers, and adult macroinvertebrate community composition; however, some recovery trend was observed on all of these parameters at 10 ppb and many at 30 ppb by the end of the 77 day study. A bluegill LC50 of 25 ppb and LC10 of 4.7 ppb was established for the first 27 days during which the four applications occurred. The North Carolina Cooperative Extension Service submitted two stream surveys conducted in five of the major Christmas tree farming in North Carolina. Although neither survey was targeted for disulfoton, nor analyzed for chemical residues they attempted to reflect the impact to aquatic macro invertebrates from the overall cultural practices associated with Christmas tree farming in Western North Carolina. The first survey, conducted by Department of Environmental Health and Natural Resources ( DEHNR) , examined one station on each of 11 streams ( Lenant, D. 1999 unpublished) . Eight of the11 streams were sampled once ( in May 39 presumably after the April/ May application of disulfoton) . The 3 other streams were sampled a second time in August as a means to correct for likely seasonal changes in the species composition of Ephemeroptera, Plecoptera and Trichoptera ( EPT) . The second survey was conducted from 12/ 98 thru early to late summer 1999 ( Sidebottom, J. 2000 unpublished) The survey examined 5 sites each consisting of an area adjacent to or downstream from a Christmas tree farm paired with its own reference site ( either a station on the same stream, but above the tree farm or a second stream) . The data collected included the total number of insects and the break out ( expressed as a % of insects) for mayflies, stoneflies, caddisflies, riffle beetles and other insects. . A species list for mayflies, stoneflies and caddisflies along with an index of their sensitivity and the dates collected was provided for 3 of the 5 sites. See the risk to aquatic organisms section on page 64 for further discussion of results and the significance to the disulfoton risk assessment. C. Toxicity to Estuarine and Marine Animals i. Estuarine and Marine Fish, Acute Acute toxicity testing with estuarine/ marine fish using the technical grade of the active ingredient is required for a chemical when the end­ use product is intended for direct application to the marine/ estuarine environment or the active ingredient is expected to reach this environment because of its use in coastal counties. The preferred test species is sheepshead minnow. Marine/ estuarine acute testing was conducted with disulfoton. Results of these tests are tabulated below. Table 22. Acute Toxicity of Disulfoton to Estuarine/ Marine Fish Species % ai LC50 ( ppb) Toxicity Category MRID No. Author/ Year Study Classification Sheepshead minnow ( Cyprinodon variegatus) Sheepshead minnow ( Cyprinodon variegatus ) 95.5 97.8 520 1000 highly toxic highly toxic 4022840 Mayer/ 1986 40071602 Surprenant/ 1986 supplemental core Sheepshead minnow ( Cyprinodon variegatus ) Sulfone metabolite 100% 1060 moderately toxic 44369901 Lam/ 1997 core Sheepshead minnow ( Cyprinodon variegatus ) Sulfoxide metabolite 98.2% 11300 slightly toxic 44369902 Lam/ 1997 core The results indicate that disulfoton is highly toxic to estuarine/ marine fish on an acute basis. The guideline requirement ( 72­ 3a) is fulfilled for parent disulfoton ( MRID # 40071602) and the sulfone and sulfoxide metabolites ( MRID # 44369901 and 44369902, respectively) . 40 ii. Estuarine and Marine Fish, Chronic Estuarine/ marine fish early life­ stage and life­ cycle tests using the technical grade of the active ingredient were required for disulfoton due to the high acute toxicity to estuarine/ marine fish. The results of these studies are as follows: Table 23. Chronic Toxicity of Disulfoton to Marine/ Estuarine Fish Species % a. i. Test Type NOEC/ LOEC ( ppb) MAT C ( ppb) Parameters Affected MRID # Author/ year Classification Sheepshead minnow ( Cyprinodon variegatus ) 97.4 early life­ stage 16.2/ 32.9 23.1 survival, length, wet weight 42629001 Lintott/ 1993 core Sheepshead minnow ( Cyprinodon variegatus ) 98 life­ cycle 0.96 1 / 2. 9 1.7 fecundity, morphological abnormalities, growth, hatching success 43960501 Dionne/ 1996 supplemental 1 An actual NOEC was not achieved in this study. The value reported here is an EC05, extrapolated using linear regression. The results indicate that disulfoton impacts the reproductive ability, as well as the growth and larval survival, of sheepshead minnows at levels as low as 2.9 ppb. The guideline requirements ( 72­ 4 and 72­ 5) are fulfilled ( MRID # 42629001 and 43960501, respectively) . iii. Estuarine and Marine Invertebrates, Acute Acute toxicity testing with estuarine/ marine invertebrates using the technical grade of the active ingredient is required for a pesticide when the end­ use product is intended for direct application to the marine/ estuarine environment or the active ingredient is expected to reach this environment because of its use in coastal counties. The preferred test species are mysid shrimp and eastern oyster. Estuarine/ marine invertebrate testing was required for disulfoton. Results of these tests are as follows: 41 Table 24. Acute Toxicity of Disulfoton to Estuarine/ Marine Invertebrates Species % ai. LC50/ EC50 ( ppb) Toxicity Category MRID No. Author/ Year Study Classification Eastern oyster ( Crassostrea virginica) Eastern oyster ( Crassostrea virginica) Eastern oyster ( Crassostrea virginica) 97.8 tech 95.5 720 900 720 highly toxic highly toxic highly toxic 40071603 Surprenant/ 1986 120480 / 1965 40228401 Mayer/ 1986 core supplemental core Mysid ( Mysidopsis bahia ) 97.8 100 very highly toxic 40071601 Surprenant/ 1986 core Brown shrimp ( Penaeus aztecus ) 95.5 15 very highly toxic 40228401 Mayer/ 1986 supplemental The results indicate that disulfoton is very highly to highly toxic to estuarine/ marine invertebrates on an acute basis. The guideline requirements ( 72­ 3b and 72­ 3c) are fulfilled ( MRID # 40071603 and 40071601, respectively) . iv. Estuarine and Marine Invertebrate, Chronic An estuarine/ marine invertebrate life­ cycle toxicity test is required for a pesticide if the end­ use product may be applied directly to water or expected to be transported to water from the intended use site, and the following conditions are met: ( 1) the pesticide is intended for use such that its presence in water is likely to be continuous or recurrent regardless of toxicity, ( 2) any aquatic acute LC50 or EC50 is less than 1 mg/ l, or, ( 3) the EEC in water is equal to or greater than 0.01 of any acute EC50 or LC50 value, or, ( 4) the actual or estimated environmental concentration in water resulting from use is less than 0.01 of any aquatic acute EC50 or LC50 value and any of the following conditions exist: studies of other organisms indicate the reproductive physiology of invertebrates may be affected, physicochemical properties indicate cumulative effects, or the pesticide is persistent in water ( e. g. , half­ life greater than 4 days) . Estuarine/ marine invertebrate testing was required for disulfoton due to its high acute toxicity to estuarine/ marine organisms, and the greater acute sensitivity of marine/ estuarine organisms compared to freshwater organisms. The results of this test are as follows: 42 Table 25. Life­ Cycle Toxicity of Disulfoton to Estuarine/ Marine Invertebrates Species % ai NOEC/ LOE C ( ppb) MATC ( ppb) Parameters Affected MRID # Author/ Year Classificatio n Mysid ( Mysidopsis bahia ) 98.5 2. 35 1 / 8. 26 5. 30 growth 43610901 Davis/ 1995 core 1 A NOEC was not achieved in the study, so an extrapolated EC05 for growth was calculated using linear regression. The MATC reported is the mean between the EC05 and LOEC values. The growth of mysids was adversely affected at levels of 8.26 ppb and higher. Production and survival of young was adversely affected at levels of 120 ppb and higher. v. Estuarine and Marine Field Studies No estuarine or marine field study data is available for disulfoton. D. Toxicity to Plants i. Terrestrial Currently, terrestrial plant testing is not required for pesticides other than herbicides except on a case­ by­ case basis ( e. g. , labeling bears phytotoxicity warnings, incidents of plant damage have been reported, or literature indicating phytotoxicity is available) . The insecticide disulfoton does have phytotoxicity warnings on product labels; therefore, Tier I terrestrial plant testing ( Guideline 122­ 1) is required for disulfoton. No such data have been submitted to date. ii. Aquatic Plants Aquatic plant testing is not required for pesticides other than herbicides except on a case­ by­ case basis ( e. g. , labeling bears phytotoxicity warnings, incidents have been reported involving plants, or literature is available that indicates phytotoxicity) . The insecticide disulfoton does have phytotoxicity warnings on product labels; therefore, Tier I aquatic plant testing ( Guideline 122­ 2) is required for disulfoton. No such data have been submitted to date. 4. Ecological Risk Assessment Risk assessment integrates the results of the exposure and ecotoxicity data to evaluate the likelihood of adverse ecological effects. One method of integrating the results of exposure and ecotoxicity data is called the quotient method. For this method, risk quotients ( RQs) are calculated by dividing exposure estimates by ecotoxicity values, both acute and chronic. RQ = EXPOSURE/ TOXICITY 43 RQs are then compared to OPP' s levels of concern ( LOCs) . These LOCs are criteria used by OPP to indicate potential risk to nontarget organisms and the need to consider regulatory action. The criteria indicate that a pesticide used as directed has the potential to cause adverse effects on nontarget organisms. LOCs currently address the following risk presumption categories: ( 1) acute ­ potential for acute risk is high regulatory action may be warranted in addition to restricted use classification ( 2) acute restricted use ­ the potential for acute risk is high, but this may be mitigated through restricted use classification ( 3) acute endangered species ­ the potential for acute risk to endangered species is high regulatory action may be warranted, and ( 4) chronic risk ­ the potential for chronic risk is high regulatory action may be warranted. Currently, EFED does not perform assessments for chronic risk to plants, acute or chronic risks to nontarget insects, or chronic risk from granular/ bait formulations to mammalian or avian species. The ecotoxicity test values ( i. e. , measurement endpoints) used in the acute and chronic risk quotients are derived from the results of required studies. Examples of ecotoxicity values derived from the results of short­ term laboratory studies that assess acute effects are: ( 1) LC50 ( fish and birds) ( 2) LD50 ( birds and mammals ( 3) EC50 ( aquatic plants and aquatic invertebrates) and ( 4) EC25 ( terrestrial plants) . Examples of toxicity test effect levels derived from the results of long­ term laboratory studies that assess chronic effects are: ( 1) LOEC ( birds, fish, and aquatic invertebrates) ( 2) NOEC ( birds, fish and aquatic invertebrates) and ( 3) MATC ( fish and aquatic invertebrates) . For birds and mammals, the NOEC value is used as the ecotoxicity test value in assessing chronic effects. Other values may be used when justified. Generally, the MATC ( defined as the geometric mean of the NOEC and LOEC) is used as the ecotoxicity test value in assessing chronic effects to fish and aquatic invertebrates. However, the NOEC is used if the measurement end point is production of offspring or survival. 44 Risk presumptions, along with the corresponding RQs and LOCs are tabulated below. Table 26. Risk Presumptions for Terrestrial Animals Risk Presumption RQ LOC Birds and Wild Mammals Acute Risk* EEC 1 / LC50 or LD50/ sqft 2 or LD50/ day 3 0.5 Acute Restricted Use EEC/ LC50 or LD50/ sqft or LD50/ day ( or LD50 0.2 < 50 mg/ kg) Acute Endangered Species EEC/ LC50 or LD50/ sqft or LD50/ day 0.1 Chronic Risk EEC/ NOAEC 1 1 abbreviation for Estimated Environmental Concentration ( ppm) on avian/ mammalian food items 2 mg/ ft 2 3 mg of toxicant consumed/ day LD50 * wt. of bird LD50 * wt. of bird * In the past, this category read Acute High Risk. The EFED is changing the wording of the conclusions to Acute Risk when the acute LOC exceedences are based solely on a screening level assessment. . 45 Table 27. Risk Presumptions for Aquatic Animals Risk Presumption RQ LOC Acute Risk* EEC 1 / LC50 or EC50 0.5 Acute Restricted Use EEC/ LC50 or EC50 0.1 Acute Endangered Species EEC/ LC50 or EC50 0.05 Chronic Risk EEC/ MATC or NOAEC 1 1 EEC = ( ppm or ppb) in water * In the past, this category read Acute High Risk. The EFED is changing the wording of the conclusions to Acute Risk when the acute LOC exceedences are based solely on a screening level assessment. . Table 28. Risk Presumptions for Plants Risk Presumption RQ LOC Terrestrial and Semi­ Aquatic Plants Acute Risk* EEC 1 / EC25 1 Acute Endangered Species EEC/ EC05 or NOEC 1 Aquatic Plants Acute Risk* EEC 2 / EC50 1 Acute Endangered Species EEC/ EC05 or NOAEC 1 1 EEC = lbs ai/ A 2 EEC = ( ppb/ ppm) in water * In the past, this category read Acute High Risk. The EFED is changing the wording of the conclusions to Acute Risk when the acute LOC exceedences are based solely on a screening level assessment. . A. Risk to Nontarget Terrestrial Animals i. Acute and Chronic Risk to Birds and Mammals from Nongranular products. Nongranular formulations of disulfoton are applied either as a foliar spray ( often by air) , or as a spray directly to soil either preplant, or to soil beside the crop ( potato side dressing) . Foliar sprays are assumed to settle directly onto vegetation and other avian and mammalian food items. The residues on these food items are estimated by using a nomograph reported Hoerger and Kenega, 1972, and as modified by Fletcher, et al, 1994. The acute risk quotients for broadcast applications of nongranular products are presented below. 46 Table 29. Avian and Mammal Acute Risk Quotients for peak exposure levels based on maximum residue values. Assuming an avian dietary LC50 of 333 ppm ( Japanese quail) , and mammal LD50 of 1.9 mg/ kg and a 3.3­ day half­ life The mammalian LD50 of 1.9 mg/ kg was used to estimate 1­ day LC50s for three different sized mammals: 15 gram mammal that eats 0.95 of its body weight per day: LC50 = 2 ppm 35 gram mammal that eats 0.66 of its body weight per day: LC50 = 2.9 ppm 1000 gram mammal that eats 0.15 of its body weight per day: LC50 = 12.7 ppm Formula: 1­ day LC50 = LD50 ( mg/ kg) / proportion of body weight consumed Use Scenarios Maximum Exposure ( EEC in ppm) 1 and RQ EEC/ LC50 BIRDS MAMMALS short grass broad leaf long grass seeds fruit short grass broad leaf long grass seeds fruit Tobacco ; soil ( ground) ; 4 lbs ai/ acre; 1 appl per season EEC RQ 960 540 440 60 2.8 1. 6 1.3 0.2 960 540 440 60 15 g 35 g 1000 g 480 331 75 270 186 42 220 151 34 30 20 4 Beans; soil ; 2 lbs ai/ acre; 1 appl per season EEC RQ 480 270 220 30 1.4 0. 8 0.7 0.1 480 270 220 30 15 g 35 g 1000 g 240 186 42 135 93 21 110 75 17 15 10 2 Broccoli and wheat; soil; 1 lbs ai/ acre; 1 appl per season. EEC RQ 240 135 110 15 0.7 0.4 0. 3 < 0.1 240 135 110 15 15 g 35 g 1000 g 120 82 18 67 46 10 55 37 8 7 5 1 Potato; soil ( ground) ; 4 lbs ai/ acre; 2 appl per season; 14 day interval EEC RQ 1010 568 463 63 3.0 1. 7 1.4 0.2 1010 568 463 63 15 g 35 g 1000 g 505 348 79 284 195 44 231 159 36 31 21 4 Pecans & potatoes; ( aerial/ ground) ; 1 lb ai/ acre; 3 appl per season; 14­ day interval ( Cotton; soil ( ground) ; 1 lb ai/ acre; 3 appl per season; 21­ day interval: : should have slightly less risk due to less distribution of spray and peak & average residues are lower ) EEC RQ 253 142 116 15 0.7 0. 4 0.3 < 0.1 253 142 116 15 15 g 35 g 1000 g 126 87 19 71 48 11 58 40 9 7 5 1 Sorghum; soil ( aerial/ ground) ; 1 lb ai/ acre; 2 appl per season; 14­ day interval ( Barley; foliar ( aerial/ ground) ; 1.0 lb ai/ acre; 2 appl per season; 21­ day interval: should have slightly lower risk off site, since peak and average residues are lower; however, on site the risk may be higher due to crop foliage being sprayed directly) ( Spring wheat; foliar ( aerial/ ground) ; 0.75 lb ai/ acre; 2 appl per season; 30­ day interval: should have slightly lower risk off site, since peak and average residues are lower. EEC RQ 252 142 115 15 0.7 0. 4 03 < 0.1 252 142 115 15 15 g 35 g 1000 g 126 87 19 71 48 11 57 40 9 7 5 1 Sorghum; foliar ( aerial/ ground) ; 0.5 lb ai/ acre; 3 appl per season; 14­ day interval ( Cotton; foliar ( aerial/ ground) ; 0.5 lb ai/ acre; 3 appl per season; 21­ day interval: should have slightly lower risk since peak and average residues are lower ) EEC RQ 126 71 58 7 0.4 0. 2 0.2 < 0.1 126 71 58 7 15 g 35 g 1000 g 63 43 9 35 24 5 29 20 4 3 2 0.5 47 1 The maximum exposure level is the highest level estimated based on the Hoerger and Kenega nomograph as modified by Fletcher, 1994. For scenarios with single applications, the maximum level is the concentration immediately after the treatment. For scenarios with multiple applications, the maximum concentration is that which occurs immediately after the final application. Bolded RQs meet or exceed the acute risk LOC ( 0.5) as well as the restricted use and endangered species LOCs. ; < 0.1 indicates no LOCs are exceeded; 0.1 or higher suggest effects to endangered or threatened species; 0.2 or higher indicates use pattern should be considered for restricted use The results of the risk screen indicate acute LOCs for risk, restricted use and endangered species are exceeded for birds at application rates above 1 lb ai / acre, and for mammals at all application rates. Although soil applications are intended to be applied to bare soil, the risk quotients do include residues on grass and broad leaf plant material. Not only does this represent risk that might occur from contaminated vegetation inadvertently left in the fields at the time of treatment, but also compensates for not being able to address such additional routes of exposure as dermal, inhalation or drinking contaminated water. Within fields at the time of planting, vegetation is expected to be sparse, thereby reducing exposure and risk; however, the vegetation on the field margins will receive drift from both ground and aerial applications. Furthermore, many of disulfoton s soil applied, soil incorporated ground applications are side dressings to emergent crops such as potatoes and cotton. In those instances, residues do appear on the under story of the crop and any weeds that are not incorporated ( especially those at the field edge) . The primary food items remaining in tilled fields are seeds and invertebrates. Insect residue were not estimated using the nomograph, however, for screening purposes, residues on insects may be similar to seeds and broad leafs, depending on the size of the insects. Another source of uncertainty in the acute risk assessment for mammals is the credibility of the 1 day LC50 values derived from the rat LD50 of 1.9 mg/ kg when comparing the range of the 1 day LC50s ( 2­ 12.7 ppm) to the rat LC50 ( 320 ppm 95% CI [ 0 ­ infinity ] ) for demeton. Demeton is an active ingredient that consists of a mixture of two isomers ­ ­ demeton ­ S and demeton­ O in a ratio of 65: 35. Demeton­ O is structurally identical to the oxygen analog of disulfoton. The following tables illustrate the toxicological similarity between demeton and disulfoton. 48 Table 30. Toxicity of Demeton to Birds and mammals Species LC50 95% CI Source ( ppm) Mallard 598 488­ 733 Hill 1975 Bobwhite quail 596 472­ 768 Hill 1975 Japanese quail 275 218­ 345 Hill 1986 Ring­ necked 665 572­ 773 Hill 1975 Pheasant Rat 319 0­ infinity McCaan 1981 LD50 ( mg/ kg) Rat ­ male 6.2 Gaines 1969 Rat­ female 2.5 Gaines 1969 Red­ wing Blackbird 2.37­ 22.0 a Schafer 1983 Table 31. Toxicity of Disulfoton to Birds and mammals Species LC50 95% CI Source ( ppm) Mallard 510 415­ 625 Hill 1975 Bobwhite quail 715 617­ 827 Hill 1975 Japanese quail 334 275­ 405 Hill 1986 Ring­ necked 634 547­ 737 Hill 1975 Pheasant LD50 95% CI ( mg/ kg) Rat ­ male 6.82 5.9­ 7.8 Gaines 1969 Rat­ female 2.3 1.7­ 3.1 Gaines 1969 Red­ wing Blackbird 3.2 1.8­ 5.6 Schafer 1983 a Range of LD50 values obtained in multiple studies 49 The above data suggests a very similar toxicity profile for demeton and disulfoton. Therefore, one might consider disulfoton s rat dietary LC50 to be approximately 320 ppm. Unfortunately, there is uncertainty for this assumption due to the extremely wide 95% CI for demeton s rat dietary LC50 study­ ­ zero to infinity. Even when allowing for the possibility the LC50 is 320 ppm would mean foliar applications of 1.0 lb ai/ A applied more than once would exceed the acute risk LOC­ ­ especially for herbivores. However, higher rates of soil directed sprays applied by ground equipment would not exceed the acute risk for herbivores. The following table presents a screening level chronic risk assessment for both birds and mammals. The toxicity values used in the table are the NOAEL from the avian reproduction study ( 37 ppm) and the mammal 2­ generation rat reproduction study ( 0.8 ppm) . Both peak EECs and time weighted averages of EECs based on Fletcher maximum residues are used to calculate risk quotients. The peak EEC is shown only for short grass, since that would represent the highest level. The time weighted averages of maximum EECs are calculated by dissipating maximum residues over 30­ days and averaging the daily residues. 50 Table 32. Avian and Mammal Chronic Risk Quotients based on peak ( for short grass) and maximum 30 day average levels. Assuming an avian NOAEL of 37 ppm ( Bobwhite) , a mammal NOAEL of 0.8 ppm and a 3.3­ day halflife Nongranular Use Scenarios 30­ day Maximum Average EEC in ppm 1 and RQs AVIAN and MAMMALS CHRONIC RQs ( EEC / NOAEL) short grass ( peak residue) broad leaf long grass seeds/ fruit Tobacco ; soil ( ground) ; 4 lbs ai/ acre; 1 appl per season EEC AVIAN RQ MAMMAL RQ 168 ( 960) 94 77 10 4.5 ( 25) 210 ( 1200) 2.5 117 2 96 0.2 12 Beans; soil ; 2 lbs ai/ acre; 1 appl per season EEC AVIAN RQ MAMMAL RQ 84 ( 480) 47 38 5 2.2 ( 13) 105 ( 600) 1.2 58 1 47 0.1 6 Broccoli and wheat; soil; 1 lbs ai/ acre; 1 appl EEC AVIAN RQ MAMMAL RQ 42 ( 240) 23 19 2.6 1 ( 6) 52 ( 300) 0.6 28 0.1 23 < 0.1 3 Potato; soil ( ground) ; 4 lbs ai/ acre; 2 appl per season; 14 day interval EEC AVIAN RQ MAMMAL RQ 331( 1010) 186 152 20 8.9 ( 27) 413 ( 1262) 5 232 4 190 0.5 25 Pecans & potatoes; ( aerial/ ground) ; 1 lb ai/ acre; 3 appl per season; 14­ day interval ( Cotton; soil ( ground) ; 1 lb ai/ acre; 3 appl per season; 21­ day interval: : should have slightly lower risk due to less off site distribution of spray and peak & average residues are lower) EEC AVIAN RQ MAMMAL RQ 88 ( 253) 49 40 5 2.4 ( 6.8) 110 ( 316) 1.3 61 1 50 0.1 6 Sorghum; soil ( aerial/ ground) ; 1 lb ai/ acre; 2 appl per season; 14­ day interval ( Barley; foliar ( aerial/ ground) ; 1.0 lb ai/ acre; 2 appl per season; 21­ day interval: should have slightly lower risk off site, since peak and average residues are lower; however, on site the risk may be higher due to crop foliage being sprayed directly) ( Spring wheat; foliar ( aerial/ ground) ; 0.75 lb ai/ acre; 2 appl per season; 30­ day interval: should have slightly lower risk off site, since peak and average residues are lower; however, on site the risk may be slightly higher due to crop ed directly) EEC AVIAN RQ MAMMAL RQ 82 ( 252) 46 38 5 2 ( 6.8) 102 ( 315) 1.2 57 1 47 0.1 6 per season. foliage being spray 51 Table 32. Avian and Mammal Chronic Risk Quotients based on peak ( for short grass) and maximum 30 day average levels. Assuming an avian NOAEL of 37 ppm ( Bobwhite) , a mammal NOAEL of 0.8 ppm and a 3.3­ day halflife Nongranular Use Scenarios 30­ day Maximum Average EEC in ppm 1 and RQs AVIAN and MAMMALS CHRONIC RQs ( EEC / NOAEL) Sorghum; foliar ( aerial/ ground) ; 0.5 lb ai/ acre; 3 appl per season; 14­ day interval EEC 44 ( 126) 24.9 20 2. 7 1.2 ( 3.4) 55 ( 157) 0.6 31 0.5 25 < 0.1 3 ( Cotton; foliar ( aerial/ ground) ; 0.5 lb ai/ acre; 3 appl per season; 21­ day interval: should have slightly lower risk since peak and average residues are lower ) AVIAN RQ MAMMAL RQ 1 The exposure level is based on the maximum level for each vegetation category in the Hoerger and Kenega nomograph as modified by Fletcher, 1994. The 30­ day average is the average of each daily residue value on the food item dissipated using a 3.3 day halflife. For uses with multiple applications, each subsequent application deposits ( adds) another maximum residue to the residue remaining from the previous application( s) and that maximum residue is dissipated over time, a total of 30 days. Bolded RQs meet or exceed the chronic risk LOC ( 1) The above two risk assessment tables were derived from exposure estimates based on maximum Fletcher residue values. The risk screen did not differentiate between foliar treatments and soil applications. It is recognized that applications to bare soil, while not precluding residues on vegetation in and around the field, probably reduce the opportunity and extent of exposure. This would be significant to both the acute risk and chronic risk. The following discussion reports the results of two field residue monitoring studies ( MRID 411169­ 01 and 41201801) reflecting the difference in exposure for liquid formulations of disulfoton associated with foliar and soil applications. Exposure from aerial applications to foliage Disulfoton as liquid Di­ syston 8E was aerially applied to potatoes 3 times at 1 lb ai/ acre in Michigan ( MRID 41201801) . Potato foliage was collected from five treated fields; 6 sample stations in each field. Samples were collected the day before and the day after each of the three treatments, and then on day 7 and 14 after the third ( final) treatment. Residues on noncrop vegetation adjacent to, and invertebrates in, treated fields were also measured. Samples were collected the day after each of three aerial applications of 1 lb ai/ acre and 7 days after the third ( last) application. The following table shows the peak, mean and upper bound of the 95 % confidence interval residue values of all fields after each treatment. 52 Table 33. The highest mean, 95 % confidence interval ( CI) and peak residues reported during the residue monitoring of terrestrial compartments following 3 aerial applications of Di­ syston 8E at 1.0 lbs ai/ A to potato fields. Use Rate Applic. potato foliage off­ site non­ target invertebrates in or Number ( mean residues ppm) vegetation ( mean near treatment site residues ppm) ( mean residues ppm) 1 9­ 59 ( 95% CI) 7.1 1.6 2 18­ 78 ( 95% CI) 25 2.7 3 20­ 60 ( 95% CI) 9.3 4.5 for all upper 95% CI= 71 upper 95% CI= 11 1 lb ai/ acre ( at 6­ 10 day intervals) upper 95% CI= 78 mean= 41 peak= 105 treatments mean = 14 peak = 152 mean = 3 peak = 16 As will be discussed these results appear to clearly support Fletcher mean values for broad leaves. The potato foliage was sprayed directly and the mean of 41 ppm for all treatments was only slightly less than Fletcher s mean for broad leaves ( 45 ppm for a single application and 47 for 3 applications) . Though the lower bound 95% CI for application # 1 was 9 ppm ( well below a single application mean of 45 ppm) , the upper bound 95% CI of 78 ppm for application # 2 was 1.7 times higher than Fletcher s mean of 47 ppm for 3 applications. . The peak on the targeted potato leaves ( 105 ppm) was less than Fletcher s maximum for broadleaves ( 135 ppm for a single application and 142 ppm for 3 applications) . Nevertheless the peak residue ( 152 ppm in application # 2) for vegetation in the adjacent areas was greater than Fletcher s maximum for both a single and for 3 applications. Wind direction at the time of application may account for the seeming contradicting location of the peak values. Approximately 50% of the time the wind was moving away from the direction of the within field sampling station and approximately 40% of the time the wind direction was away from the sample station just outside the field perimeter. These monitoring results, coupled with those for azinphos methyl applied to apple orchards ( MRID 411397­ 01 & 411959­ 01) , support EFED s assumption that foliar residues resulting from both single and multiple applications to foliage are estimated reasonably well using Fletcher values in a dissipation model. Concerning the residues on invertebrates ( peak of 16 ppm and an upper bound mean 95% CI of 11 ppm) , it is acknowledged that an assumed direct application did not produce residues equal to those on broadleaves ( theoretically reflective of small insects) , but did compare favorably with Fletcher s estimates for large insects ( maximum of 16 ppm and a mean of 7 ppm for 3 applications) . The question arises as to whether the sample pool consisted of small or large 53 invertebrates. Furthermore, some of the individuals comprising the sample may have been on the underside of a leaf at the time of application and only acquired residues from contacting contaminated soil or leaves. Whereas those individuals ( especially the potato beetle) sprayed directly had died. These individuals contained higher residues, but were not part of the pool. Exposure from ground applications sprayed to soil A residue monitoring study was conducted in potato fields in Michigan ( MRID 411189­ 01) . Disulfoton was applied at 3 lb ai/ A as an in­ furrow spray application and again as a side dressing after 6­ 7 weeks. Invertebrates, crop and other vegetation, and soil were sampled within 24 hours after both applications. Invertebrates were collected in grids of pitfall traps in five fields, and potato beetles were collected on foliage by sampling stations. Soil samples were collected from the soil surface to a depth of 2­ 3 cm. Vegetation was available for sampling only after the second application. Mean and maximum residue values are found in the following table. The limit of detection was 0.09 ppm. Table 34. Highest mean and ( maximum) residues reported during the residue monitoring of terrestrial compartments following 2 soil applications by ground equipment of Di syston 8E at 3.0 lbs ai/ A Application Invertebrates Soil Edge of field Potato Foliage ( ppm) ( ppm) vegetation ( ppm) ( ppm) 1 ( in furrow) 0.3 ( 0.9) 0.19 ( 1.8) 0.2 ( 0.9) 4.0 ( 26) * 2 ( side dressing) 0.4 ( upper 95% 2.9 ( upper 95% 3.5 ( upper 95% 8.0 upper 95% CI= 0.6) 1.8 14) 22 CI= 11) 54 CI= 16) 44 * Just prior to 2 nd application In contrast to foliar applications, ground applications to soil result in residues far below those predicted in EFED' S initial screen using Fletcher values. However it is noted ( especially for systemic pesticides) , residues are found in food items of non target organisms. In addition, as was previously stated, compensation must be made for the condition of a field ( the vegetation and invertebrates in the field at the time of application) and other routes of exposure besides ingestion of food. Mammals appear to be at risk both acutely and chronically from soil applications ( particularly side dressing) . The peak and mean residues in all media, except for invertebrates, exceed the the extrapolated 1 day LC50' s ( ranging for 2 to 12.7 ppm) and the chronic NOAEC ( 0.8 ppm) . The Agency acknowledges that the extrapolated mammalian 1 day LC50s for disulfoton may exaggerate the actual acute risk. Risks from foliar treatments Tests were conducted by the Denver Wildlife Research Center ( Evans et al. 1970; MRID 54 413591­ 01) to examine the feasibility of using foliar applications of disulfoton to control jackrabbits. Although few details of the tests were provided, some information was gathered on risks to wildlife from foliar applications of disulfoton. Unspecified numbers of jackrabbits and cottontail rabbits were introduced into enclosed plots six hours after foliar application to barley plants ( 12 days post emergence) at rates of 1, 2, 5, or 25 lb ai/ A. None of the cottontails died. No jackrabbit mortality was reported for the 1 lb ai/ A application, but mortality was 100% at rates of 2, 5, and 25 lb ai/ A. Additional tests were then conducted in enclosures planted with barley, alfalfa, wheat, or range grasses treated with a foliar application of 2 lb ai/ A. Unspecified numbers of jackrabbits, cottontails, pigmy rabbits, domestic rabbits, wild and game farm pheasants, and mallards were introduced post­ spray and exposed for anywhere from 0.5 to 13 days. Most or all jackrabbits died; but no mortality of other species was reported. Cholinesterase levels were reported as normal for cottontails, partridge, sage grouse, and pheasants. Jackrabbits killed on spray plots in the pen tests also were fed to unspecified numbers of coyotes, dogs, golden eagles, a great­ horned owl, and a red­ tailed hawk. The number of jackrabbits consumed and their residue levels were not reported. Commercial mink also were fed digestive tracts, eviscerated carcasses, and uneviscerated carcasses of jackrabbits killed on 2 lb ai/ A spray plots. All secondary consumers fed continuously for anywhere from 3 to 30 days with no mortality, although some ChE depression was noted. In conclusion, it appears that foliar applications up to 1.0 lb ai/ A ( unless applied 3 or more times at intervals of less than 10 days) will not result in mortality to non rodents. Because dietary LC50 values for birds are in the range of 333 to 827 ppm, EFED initially concluded that residues at these levels are not likely to be a significant acute risk to birds. More will be said abut the uncertainty of this conclusion in the risk characterization section. However there is a potential for chronic effects to birds since the NOAEC of 37 is exceeded by the peak residues found in crop foliage ( 44 ppm) and non crop vegetation ( 54 ppm) along the field borders. Given the fact that the LOAEC ( 78 ppm for bobwhite quail) is only slightly above the field residues there is uncertainty as to what duration of exposure will produce an adverse reproductive effect in birds. Furthermore some endpoints not examined under laboratory conditions could be negatively impacted under field conditions. These end points could include successful mating, nesting behavior or care of young. Adverse impact may occur either after a brief exposure to concentrations at the NOAEC level or a longer period at even lower levels. ii. Risk from Granular Formulations of Disulfoton Birds and mammals may be exposed to granular pesticides ingesting granules when foraging for food or grit. They also may be exposed by other routes, such as by walking on exposed granules or drinking water contaminated by granules. The number of lethal doses ( LD50s) that are available within one square foot immediately after application ( LD50s/ ft 2) is used as the risk quotient for granular/ bait products. Risk quotients are calculated for three separate weight class of animals: 1000 g ( e. g. , waterfowl or medium sized mammal) , 180 g ( e. g. , upland gamebird or 55 small mammal) , and 20 g ( e. g. , songbird or very small mammal) . The acute risk quotients for broadcast applications of granular products are tabulated below. Table 35. Avian and Mammal Acute Risk Quotients for Granular Products ( Broadcast) Based on a Mallard LD50 of 6.54 mg/ kg and a rat LD50 of 1.9 mg/ kg. LD50s per animal are calculated by multiplying the weight of the animal ( kg) by the LD50 in mg/ kg. 0. 020 Kg ( 20 g) bird LD50= 0. 13mg per bird Mammal LD50= 0. 038mg per mammal 0. 180 Kg ( 180 g) bird LD50= 1. 17 mg per bird Mammal LD50= 0. 34mg per mammal 1. 00 Kg ( 1000 g) bird LD50= 6. 54 mg per bird Mammal LD50= 1. 9mg per mammal Site/ Application Method/ Rate in lbs ai/ A Mammal or Bird Body Weight ( g) Mammal Acute RQ 1 ( LD50/ ft 2 ) Avian Acute RQ 1 ( LD50/ ft 2 ) Sorghum or Barley unincorporated 1 ( 10.41 mg/ sq ft) 20 273 a 79 a 1 ( 10.41 mg/ sq ft) 180 30 a 8 a 1 ( 10.41 mg/ sq ft) 1000 5 a 1. 5 a 1 RQ= mg per sq ft / LD50 per animal mg/ sq ft = ( app rate [ lb ai per acre ] * 453,590 [ mg per lb ] ) / 43,560 [ sq ft per acre ] LD50 per animal = LD50 ( mg/ kg) * wt ( kg) a= acute risk, restricted use and endangered species LOCs have been exceeded The results of this risk screen indicate that for broadcast applications of granular products, avian acute risk, restricted use, and endangered species levels of concern are exceeded at application rates equal to or above 1.0 lb ai/ A. 56 57 The acute risk quotients for banded or in­ furrow applications of granular products are as follows: Table 36. Avian and Mammal Acute Risk Quotients for Granular Products ( Banded or In­ furrow) Based on a Mallard LD50 of 6.54 mg/ kg and a rat LD50 of 1.9 mg/ kg. LD50s per animal are calculated by multiplying the weight of the animal ( kg) by the LD50 in mg/ kg. 0. 020 Kg ( 20 g) bird LD50= 0. 13mg per bird Mammal LD50= 0. 038mg per mammal 0. 180 Kg ( 180 g) bird LD50= 1. 17mg per bird Mammal LD50= 0. 34mg per mammal 1. 00 Kg ( 1000 g) bird LD50= 6. 54mg per bird Mammal LD50= 1. 9mg per mammal Site/ method oz ai per 1000 ft of row Band Width % granules left on surface after soil incorp. Exposure Concentration mg ai/ sq ft RQ ( LD50 / sq ft) AVIAN MAMMAL 20 gram animal 180 gram animal 1000 gram animal Tobacco/ Banded / Incorporated 6 0.5 15 51 avian 392a 43a 7a ( 4.0 lb ai/ A) mammal 1342a 150a 26a Potatoes/ In furrow / Incorporated 3.45 ( 3.0 lb ai/ A) 0.5 1 1.9 avian 15a 1.6a 0.3b mammal 51a 5.7a 1.0a Potatoes/ banded / Incorporated 3.45 ( 3.0 lb ai/ A) 0.5 15 29 avian 225a 25a 4.5a mammal 763a 85a 15.2a Vegetable ( cole crops, etc. ) / banded, incorporated 1.1 0. 5 15 9.36 avian 72a 8a 1.4a ( 0.97 lb ai/ A) mammal 246a 27a 4a 1 RQ= mg per sq ft / LD50 per animal mg/ sq ft = [ ( oz ai per 1000 ft * 28349 mg/ oz) ] [ % % unincorporated ( decimal) / bandwidth ( ft) * 1000 ft ] LD50 per animal = LD50 ( mg/ kg) * wt ( kg) a= acute risk, restricted use and endangered species LOCs have been exceeded b= restricted use and endangered species LOCs have been exceeded 58 Table 37. Avian and Mammal Acute Risk Quotients for Granular Products Based on a Mallard LD50 of 6.54 mg/ kg and a rat LD50 of 1.9 mg/ kg. LD50s per animal are calculated by multiplying the weight of the animal ( kg) by the LD50 in mg/ kg. 0. 020 Kg ( 20 g) bird LD50= 0. 13mg per bird Mammal LD50= 0. 038mg per mammal 0. 180 Kg ( 180 g) bird LD50= 1. 17mg per bird Mammal LD50= 0. 34mg per mammal 1. 00 Kg ( 1000 g) bird LD50= 6. 54mg per bird Mammal LD50= 1. 9mg per mammal Site/ method lbs ai/ acre Band Width % granules left on surface after soil incorp. Exposure Concentration mg ai/ sq ft RQ ( LD50 / sq ft) AVIAN MAMMAL 20 gram animal 180 gram animal 1000 gram animal Rasberries/ Banded / Incorporated 11.75 oz ai/ 1000 ft ( 8 lb ai/ A) 2 15 25 avian 192a 21a 3.8 mammal 657a 73a 13a Christmas trees / spot treatment broadcast ( Sec 3) 3.75 oz prod/ tree with 1.5 inch diam at 4 ft. 0.562 oz ai / tree( ~ 2 sq ft) 1700 trees/ A ( 59.7 lbs ai/ A) 100 7966b avian 61276a 6808a 1218a mammal 209631a 23429a 4193a Christmas trees / spot treatment broadcast ( North Carolina 24 C) 5 gr product per tree 0.026 oz ai / tree( ~ 2 sq ft) 1700 trees/ A ( 2. 76 lbs ai/ A) 100 368b avian 2830a 314a 56a mammal 9684a 1082a 193a 1 RQ= mg per sq ft / LD50 per animal mg/ sq ft = [ ( oz ai per 1000 ft * 28349 mg/ oz) ] [ % % unincorporated ( decimal) / bandwidth ( ft) * 1000 ft ] LD50 per animal = LD50 ( mg/ kg) * wt ( kg) a= acute risk, restricted use and endangered species LOCs have been exceeded b= estimated by : ( oz ai/ tree) ( 28349 mg/ oz) / 2 sq ft/ tree The disulfoton 15G ( 15% ai) granule is applied in cotton, grains, sorghum, peanuts, soybeans, tobacco, coffee, nonbearing fruit trees, pecans, vegetables, flowers, shrubs, trees, and ground cover. The results of this screening level risk assessment indicate that for both birds and mammals acute risk, restricted use, and endangered species levels of concern are exceeded for banded and in­ furrow applications of granular products at registered maximum application rates equal to or above the lowest rate of 1.1 oz ai/ 1000 ft. Granules may be intentionally consumed as grit, mistaken for seeds, or may be ingested if attached to food items ( e. g. , earthworms) . Even when granules are incorporated that does not preclude exposure to birds and mammals. Fisher and Best ( 1995) examined granule availability in Iowa cornfields and found that 6% of granules applied in banded treatment were available on the soil surface, and granules were found in gizzards of 39% of 256 birds collected. The LD50 per square foot screening approach for granulars can be refined by estimating how many disulfoton granules might be eaten by a bird in a day. Based on field counts and granule voiding experiments, 95% of the birds collected in Iowa cornfields were estimated to consume < 18 granules per day. For the savannah sparrow ( Passerculus sandwichensis ) , median consumption was 11 granules per day, with 5% of the individuals estimated to consume > 23 granules/ day ( Fisher and Best 1995) . A Di­ Syston 15G granule weighs 0.083 mg ( Balcomb et al. 1984, cited in MRID 413591­ 01) and thus contains 0.01245 mg ai. Eleven granules would contain 0.13695 mg ai. If an adult savannah sparrow weighs 20 g ( Dunning 1984) ; then an individual consuming 11 granules in a day ingests 0.13695 mg ai which equates to 6.8475 mg ai/ kg of its body weight. Assuming the LD50 for the sparrow is comparable to that for the red­ winged blackbird ( 3.2 mg/ kg) , a sparrow ingesting 11 granules would be exposed to 2.14 times the theoretical dose lethal to 50% of the population. In a laboratory study, 10­ 20 granules of Di­ Syston 15G were required to kill one out of five house sparrows ( weighs 28 gr) and red­ winged blackbirds ( weighs 60 gr) respectively ( Balcomb et al. 1984) . Since the test level in the study were 1,5,10 and 20 granules; it is possible the actual number of granules required to kill a house sparrow was from 6 to 9 and 11 to 19 for the red­ wing blackbird. Disulfoton granules may pose an even greater risk to mammals than to birds. Mammals may not intentionally eat granules, but granules can be consumed if attached to food items ( e. g. , soil invertebrates, seeds on the ground) or mistaken as food items ( e. g. , seeds) . Assuming an LD50 of 1.9 mg/ kg as for the female rat, a 20­ g rodent would need to ingest only 0.038 mg ai ( 1.9 mg ai x 0.02 kg bw) to receive a dose lethal to 50% of the population. That dose could theoretically be obtained by eating 3 granules ( 0.038 mg ai/ 0.01245 mg ai/ granule) . The point to emphasize is that for any application described in the above table, at the time of application and until the granules disintegrate, there are sufficient numbers of unincorporated granules within a square foot to cause mortality ­ ­ especially to small birds and mammals. . Besides the intentional or inadvertent consumption of granules by birds and mammals, additional oral exposure to disulfoton is possible from consumption of soil during the disintegration of the granules. Estimates of soil ingestion by wildlife indicate that soil can comprise as much as 17­ 30% of the diet of species of some sandpipers and woodcock, presumably from consumption of soil organisms such as earthworms, which typically contain 20­ 30% soil ( Beyer et al. 1994) . Other species reported with soil in their diet include Canada geese ( 8% soil) , raccoon ( 9% soil) , armadillo ( 17% soil) , wood ducks ( 11% soil) , wild turkeys ( 9% soil) , and white­ footed mice ( Peromyscus leucopus ) fed foods containing either 0, 2% , 5% , and 15% soil ate equivalent amounts of food regardless of soil content ( Beyer et al. 1994) . Dermal contact of granules and contaminated soil also could increase an individual' s exposure. Disulfoton is a Toxicity Category I pesticide for dermal toxicity ( LD50 of 3.6 mg/ kg for mammals) , although the importance of dermal exposure of birds and mammals is uncertain in the field. Lastly, since disulfoton is systemic, non target organisms are exposed when ingesting invertebrates and plant foliage where granules have been applied. A field study conducted in potato fields in Washington indicated that application of 15G granules can cause mortality of birds and mammals ( MRID 410560­ 00) . The fields were treated with two applications, each at a rate of 3 lbs ai/ A ­ ­ one in furrow at planting and one side dressing 4 to 6 weeks later. Forty­ one bird species and 8 mammal species were observed in the potato fields during the study. During transect searches, 32 casualties were reported. However, 59 based on the Agency' s guidance for terrestrial field studies ( EPA 1986) , EFED concluded that the amount of area searched ( 5.5 acres) was not sufficient and that transects were too far apart for adequately locating carcasses. Moreover, only 2 of the 32 casualties were analyzed for disulfoton residues. Despite methodological problems with the study, EFED accepted it as a core study because it demonstrated mortality to wildlife inhabiting potato fields treated with 15G granules. Both in­ furrow and banded applications indicate mortality may be expected to occur. The table below summarizes the residue levels resulting from the two soil incorporated applications of Di­ Syston 15G. Table 38. Mean and ( maximum) total disulfoton residues resulting from two applications of Di­ Syston 15 G Application Invertebrates Potato Foliage ( ppm) ( ppm) 1 ( in furrow) 0.14 ( 0.41) n/ a 2 ( side dressing) 0.9 ( 5.2) 7.5 ( 25) Although these residues are considerably below concentrations anticipated to cause mortality, when coupled with 1) other routes of exposure­ ­ ingestion of granules and drinking from contaminated puddles ­ ­ and 2) hypersentivity of some non targets organisms ( i. e. , jackrabbits and Swainson s hawks) some mortality is possible. The application of granular formulations of disulfoton to raspberry and Christmas tree may include hand operation ­ ­ either dispensing or incorporation of granules; consequently there is a greater potential for granules to remain above ground. Although the labels for Christmas trees refers to incorporation or watering ( within 48 hours) usually incorporation can not be conducted and April rainfall rather than irrigation is generally relied upon to activate the granules. Therefore the granules may remain intact and above ground for at least several days. There are several additional factors that confound the amount and type of exposure wild life may encounter from disulfoton on the granules. Number one, the distribution of the granules under the drip line will range from a teaspoon being fanned out in several square feet or else a side dressing along two sides of each row of trees. Number two, present cultural practices include leaving vegetation between the rows and under the drip line. This vegetation may obscure an animal s view of granules that have sifted through the cover or if moist, allow the granule to adhere to the leaf surface and be consumed by herbivores. Number three, after a rainfall the granules will dissolve and residues of disulfoton will appear in puddles and be taken up in vegetation. In light of these factors there is a high degree of uncertainty as to the degree of risk to wild life. Christmas tree farms and the adjacent areas ­ ­ forests and or pasture provide excellent habitat for a great variety of wild life. The North Carolina Christmas Tree community has submitted numerous testimonials emphasizing the ever increasing numbers and diversity of wild life . This includes game animals such as turkey rearing young amidst the trees, song birds, rodents and foxes. Although this information is intended to suggest there is little or no negative impact from not only disulfoton, but other pesticides or cultural practices as well, the Agency would prefer to receive documented surveys or research before making a final determination. 60 Chronic Risk from Granular Formulations Estimating long term exposure from granular applications is difficult, since the granules are not expected to remain in tact over extended periods. The chemical is expected to become distributed in the soil, as the granules dissipate. . However, given that disulfoton is chronically toxic to birds and mammals at low dietary concentrations, granular applications may contribute to chronic risk. iii. Insects Currently, EFED does not assess risk to nontarget insects. Results of acceptable studies are used for recommending appropriate label precautions. Disulfoton and its sulfoxide and sulfone metabolites are classified as highly toxic to the honeybee on an acute contact and oral basis, therefore, toxicity label language is required. Current labeling includes the appropriate bee toxicity warning statement. B. Risk to Nontarget Freshwater and Estuarine Animals The following table shows the specific toxicity values that were used in assessing acute and chronic risk to aquatic and marine organisms. Species that demonstrated ranges of sensitivity were used, not just the most sensitive species. 61 Table 39. Toxicity endpoints used in assessing risk of aquatic organisms for disulfoton Species * Test Type Results ( ppb) Source of Data Freshwater Species Rainbow trout Acute LC50= 1850 40098001 Bluegill Acute LC50= 39 00068268 Channel catfish Acute LC50= 4700 40098001 Rainbow trout Early Life Stage NOAEC= 220 41935801 Bluegill Early Life Stage* * estimated NOAEC= 4.6 No study conducted Water flea Acute EC50= 13 00143401 Glass shrimp Acute EC50= 3.9 40094602 Stonefly Acute EC50= 5 40098001 Water flea Reproduction NOAEC= 0.037 41935802 Marine Species Sheepshead minnow Acute LC50= 520 40228401 Sheepshead minnow Early Life Stage NOAEC= 16.2 42629001 Sheepshead minnow Full Life Cycle EC05= 0.96* * * 43960501 Eastern Oyster Acute EC50= 720 40228401 Mysid Acute EC50= 100 40071601 Brown shrimp Acute EC50= 15 40228401 Mysid Life Cycle EC05= 2.35* * * 43610901 * The species listed and used in risk assessment were selected from the toxicity data because they seemed to represent a distribution of sensitivity. * * An early life stage study was not conducted with bluegill. The only freshwater fish chronic study was with rainbow trout. In the case of disulfoton, rainbow trout are significantly less sensitive than bluegill. So in an effort to translate this difference in sensitivity to the chronic risk assessment, a NOAEC for bluegill was calculated based on the ratio of acute toxicity. The lowest rainbow trout LC50= 1850 ppb. The bluegill LC50= 39. The ratio of trout to bluegill is 39/ 1850= 0.021. 0.021 X the trout NOAEC of 220 ppb = 4.6 ppb. There is uncertainty in this value, since it is estimated, and not derived from an actual toxicity test. * * * The study did not produce a NOAEC, however, the responses at the different concentrations were plotted used to estimate the concentration at which 5% effects would be expected, or an EC05. Tier II estimated environmental concentrations ( EECs) for a variety of disulfoton applications were calculated to generate aquatic exposure estimates for use in the ecological risk assessment. In the risk quotient tables below, both freshwater and marine species are included in the same table. The first table presents the acute risk quotients based on modeling, the second table presents the chronic risk quotients. The modeling represents exposure in a 1­ hectare 2­ meter deep enclosed pond receiving runoff and drift from a 10 hectare treated field. This scenario is considered relatively conservative, but may not represent the highest exposure in all cases, since water bodies can be shallower, and thus may have higher exposure potential. On the other hand, many water bodies are larger, and have flow that may dilute concentrations. Long­ term exposures are especially uncertain when applied to flowing streams and rivers and estuaries and 62 may over­ estimate the risk. However, not all estuaries involve rapid exchange of water, so these estimates are not automatically considered overly conservative for all estuaries. . Table 40. Acute risk quotients for freshwater and marine fish and invertebrates . Acute risk quotients; peak EEC/ LC50 Use Pattern EEC ppb Freshwater surrogate species Marine surrogate species fish invertebrates fish invertebrates LC50 ( ppb) > bluegill 39 rainbow trout 1850 channel catfish 4700 glass shrimp 3.9 stonefly 5 water flea 13 sheepshead m. 520 brown shrimp 15 mysid 100 oyster 720 Tobacco soil 4.0 lb ai/ a 1 app per yr incorp 2.5 inches peak 26.7 0.6 < 0.01 < 0.01 6.8 5. 3 2.0 0.05 1.7 0.2 0. 03 Tobacco soil ( granular) 4.0 lb ai/ a 1 app per yr incorp 2.5 inches peak 18.4 0. 4 < 0.01 < 0.01 4.7 3. 6 1.4 0.03 1.2 0.18 0.02 Potato foliar 1.0 lb ai/ a 3 app at 14 day int. not incorporated peak 15.0 0. 3 < 0.01 < 0.01 3.8 3. 0 1.1 0.02 1.0 0.1 0. 02 Cotton soil 1.0 lb ai/ a 3 app at 21 day int. not incorporated peak 14.8 0. 3 < 0.01 < 0.01 3.7 2. 9 1.1 0.02 0.9 0.14 0.02 Barley foliar 1.0 lb ai/ a 2 app at 21 day int. not incorporated peak 9.2 0. 2 < 0.01 < 0.01 2.3 1. 8 0.7 0.01 0.6 0.09 0.01 Spring Wheat foliar 0.75 lb ai/ a 2 app at 30 day int. not incorporated peak 8.9 0.2 < 0.01 < 0.01 2.2 1. 7 0.6 0.07 0.59 0.08 0.01 Potato soil 4.0 lb ai/ a 2 app at14 day int. incorp to 2.5 inches peak 7.1 0. 18 < 0.01 < 0.01 1.8 1. 4 0.5 0.01 0.47 0.07 < 0.01 Barley soil ( granular) 0.83 lb ai/ a 2 app at 21day int. not incorporated peak 7.1 0. 18 < 0.01 < 0.01 1.8 1. 4 0.5 0.01 0.47 0.07 < 0.01 Risk quotients exceeding the acute risk LOC of 0.5 are bolded The LOC for restricted use is 0.1 The LOC for endangered species is 0.05 The screening assessment results indicate that except for the highest application to tobacco, the acute risk LOC has not been exceeded for fish. Estuarine fish appear to be a far less risk than freshwater fish. On the other hand, the RQs for all modeled uses exceed the acute risk LOC for 63 64 fresh water invertebrates. Although two of the three test species of estuarine invertebrates did not suggest risk, based on the brown shrimp, estuarine invertebrates are at acute risk from all modeled crops. Especially for estuarine invertebrates there is uncertainty as to the degree of the acute risk. Table 41. Chronic risk quotients for freshwater and marine fish and invertebrates . Chronic risk quotients; ave. EEC/ NOAEC or EC05 Use Pattern EEC ppb Freshwater surrogate species Marine surrogate species fish inverteb rates fish inverte brates NOAEC ( ppb) > bluegill 4. 6 rainbow trout 220 water flea 0. 037 sheepshea d life cycle 0. 96 Sheepshead early life st. 16. 2 Mysid life cycle EC05= 2. 35 Tobacco soil 4.0 lb ai/ a 1 app per yr incorp 2.5 inches 21­ d 17.9 60­ d 9.9 2 < 0. 1 483 10.3 0.6 7.6 Tobacco soil ( granular) 4.0 lb ai/ a 1 app per yr incorp 2.5 inches 21­ d 12.5 60­ d 6.7 1.4 < 0. 1 337 6.9 0.4 5 Potato foliar 1.0 lb ai/ a 3 app at 14 day int. not incorporated 21­ d 10.4 60­ d 6.9 1.5 < 0. 1 281 7.1 0.4 4.4 Cotton soil 1.0 lb ai/ a 3 app at 21 day int. not incorporated 21­ d 8.0 60­ d 4.9 1 < 0. 1 216 5.1 0.4 3.4 Barley foliar 1.0 lb ai/ a 2 app at 21 day int. not incorporated 21­ d 5.9 60­ d 3.7 0. 8 < 0.1 159 3.8 0.2 2.5 Spring Wheat foliar 0.75 lb ai/ a 2 app at 30 day int. not incorporated 21­ d 4.5 60­ d 2.6 0. 5 < 0.1 121 2.7 0.1 1.9 Potato soil 4.0 lb ai/ a 2 app at14 day int. incorp to 2.5 inches 21­ d 4.3 60­ d 2.3 0. 5 < 0.1 116 2.4 0.1 1.8 Barley soil ( granular) 0.83 lb ai/ a 2 app at 21day int. not incorporated 21­ d 5.4 60­ d 3.8 0. 8 < 0.1 145 3.9 0.2 2.2 Risk quotients exceeding the chronic risk LOC are bolded Risk quotients for invertebrates and fish are based on 21 and 60 day EECs respectively Both fish and invertebrates are likely to experience chronic effects based on modeled EECs. Freshwater invertebrates are at much greater risk than fish or estuarine invertebrates. Risk to Freshwater Organisms from the use of Disulfoton 15 on Christmas Trees in North Carolina The use of Disulfoton 15 G in Christmas tree farms at this time can not be modeled for potential surface water contamination. EFED assumes the estimated concentration for the North Carolina 24 ( c) use pattern ­ ­ 2.75 lbs ai/ A unincorporated ­ ­ may be similar to the values for the single 4.0 lb ai/ A incorporated application of granular disulfoton to tobacco. Based on this assumption there is acute risk to aquatic invertebrates and chronic risk to freshwater fish and aquatic invertebrates. Since this preliminary screen of the 24( c) exceeds levels of concern, the Sec 3 use at 59.7 lbs ai/ A would exceed ( perhaps by 20 fold) the same levels of concern for aquatic life and the acute risk for fish as well. However, even if the receiving body of water was a pond ( as was modeled for tobacco) this assumption has uncertainty because although the Christmas tree use pattern has a lower rate and current cultural practices recommend maintaining vegetation under the trees and between the rows; nevertheless the material is not incorporated. Therefore while the first two conditions may reduce the estimated concentrations below those for tobacco, the third condition may increase the concentrations. The North Carolina Christmas tree industry has provided information that has contributed to a refinement of EFED s risk assessment for aquatic organisms from Christmas tree farming. Firstly, the primary and nearly exclusive use site for Disulfoton 15 G on Christmas trees throughout the United States is on Fraser fir grown in 6 counties in Western North Carolina, thereby localizing the exposure and precluding any estuarine exposure. Secondly, the primary aquatic sites adjacent to tree farms are streams, not ponds. Residues in these streams will be lower and of shorter duration than would be expected for a pond. Thirdly, two rapid assessment macro invertebrate surveys of streams in the Western region of North Carolina have been submitted. The following is a brief discussion of those results. In the 1998 study conducted by the North Carolina Department of Environmental Health and Natural Resources ( DEHNR) , 8 of 11 streams were sampled once in May ( presumably after the April/ May application of disulfoton) at one location. The 3 other streams were sampled a second time in August as a means to correct for likely seasonal changes in the species composition of Ephemeroptera, Plecoptera and Trichoptera ( EPT) . These three Orders of invertebrates are considered to be sentinel species indicative of overall water quality. In spite of some concerns such as the mixed influence of cattle or development along with Christmas tree farms and the preference for a more rigorous study design ( i. e. residue analysis and more frequent sampling) the Agency considered the survey s utility in light of several factors: an on­ site visit in June 2000; the support for the protocol as described in the EPA publication: EPA 841­ B­ 99­ 002; the nation wide use of disulfoton on Christmas trees is primarily in this region where it has been used for 20 years and the submission of a second survey conducted from December 1998 through mid to late summer 1999. 65 The second survey examined 5 sites each consisting of an area adjacent or downstream from a Christmas tree farm paired with its own reference site ( either a station on the same stream, but above the tree farm or a second stream. Quantification ­ included the total number of insects and the break out ( expressed as a % of insects) for mayflies, stoneflies, caddisflies, riffle beetles and other insects. A species list for mayflies, stoneflies and caddisflies along with and index of their sensitivity and the dates collected was provided for 3 of the 5 sites. Data for each of the reported 3 pairs of sites were analyzed using ANOVA. Unlike the DEHNR survey where various communities ( leaf packs, riffles, banks and large rocks and logs) were sampled, only the riffle community was sampled. Like the DEHNR survey, no residue analysis was performed for any pesticide including disulfoton. Again the researcher made the point that the protocol seeks to detect whether an impact is occurring due to the combination of numerous influences without quantifying the degree of exposure to a specific chemical( s) . The Agency concurs with the investigators that when implementing ( but not limited to) conservation measures such as establishing ground cover throughout the farm, constructing and maintaining the fewest number of roads and bridges, creating a riparian zone to include vegetation and trees and employing Integrated Pest Management practices, there appears to be . . . . little negative effect on the fauna of adjacent streams. . . . The slight negative effect that was observed seemed to impact stoneflies ( Plecoptera) more than the two other orders caddisflies ( ( Trichoptera) and mayflies ( Ephemeroptera) ­ that were the focus of the survey. In summary, the two surveys suggests that when conservation measures associated with Christmas tree farming in the Western counties of North Carolina are implemented, there may be only slight, short term impact to aquatic macro invertebrates from disulfoton use. Aquatic macro invertebrates appear to have the capacity to recover from any impact that could be caused by disulfoton use on Christmas trees in Western North Carolina. 66 C. Exposure and Risk to Nontarget Plants Although Tier I terrestrial and aquatic plant testing is required for disulfoton due to label phytotoxicity warnings, no data on plant toxicity has been submitted at this time. Therefore, the risk to nontarget plants cannot be assessed. 5. Endangered Species The following endangered species LOCs have been exceeded for disulfoton: avian acute, avian chronic, mammalian acute, mammalian chronic, freshwater fish acute, freshwater invertebrate acute, freshwater invertebrate chronic, marine/ estuarine fish acute, marine/ estuarine fish chronic, marine/ estuarine invertebrate acute, and marine/ estuarine invertebrate chronic. Endangered terrestrial, semi­ aquatic and aquatic plants also may be affected, based on label statements indicating phytotoxicity. The OPP Endangered Species Protection Program ( ESOP) is developing ways to protect endangered species from hazardous pesticides. Limitations on the use of disulfoton will be required to protect endangered and threatened species, but these limitations have not been defined and may be formulation specific. EPA anticipates that a consultation with the Fish and Wildlife Service may be conducted in accordance with the species­ based priority approach described in the ESOP. After completion of consultation, registrants will be informed if any required label modifications are necessary. Such modifications would most likely consist of the generic label statement referring pesticide users to use limitations contained in county Bulletins. 6. Disulfoton Incident Reports There are both bird and fish kills reported for disulfoton. The following are summaries of incidents reports available to the Agency. BIRD INCIDENTS: 1. Young County, TX, 6/ 18/ 93. Eighteen Swainson s hawks were found dead and one found severely disabled in a cotton field. The cotton seed had been treated with disulfoton seed treatment prior to planting, about 10 days before the birds were discovered. According to field personnel, no additional applications of organophosphorus or carbamate pesticides had been made in the vicinity of the field. Autopsies revealed no signs of trauma or disease. Laboratory analysis of the birds revealed insect material in the gastrointestinal tracts. Residue chemistry analysis of this material indicated the presence of disulfoton ( approximately 7 ppm) ; no other organophosphorus or carbamate insecticides were present. Apparently, the hawks had fed on insects, which had been feeding on the young cotton plants. The systemic nature of the pesticide appears to have resulted in plant residues, which were then taken up by the insects, at levels high enough to cause mortality in the hawks. This may be the first documented incident of this type of exposure in a captor species. ( L. Lyon, Div. of Environmental Contaminants, U. S. Fish and Wildlife Service, Arlington, VA. Presented at the SETAC 18th annual meeting, San Francisco, CA, 1997) . The Agency has been able to confirm the incident through personal communication with Stephen Hamilton, the Special Agent of the U. S. Fish and Wildlife in charge of the investigation, who stated there was no evidence of misuse. 2. Sussex County, DE, 4/ 26/ 91. Nine American robins found dead following application of granular disulfoton at a tree nursery. Corn and soybeans were also in the vicinity. No 67 laboratory results were obtained. Certainty index is probable for disulfoton. ( Incident Report No. I000116­ 003) . 3. Puerto Rico, 1/ 24/ 96. Six grackles fell dead from a tree in the yard of a private residence. A dead heron and a dead owl were also found in the vicinity. The use site and method were not reported. Birds had depressed acetyl cholinesterase. Residue analysis on gut contents of one of the grackles found disulfoton residues of 12.37 ppm wet weight. Certainty index of this incident is highly probable for disulfoton. ( Incident Report No. I003966­ 004) . FISH INCIDENTS 1. Onslow County, NC, 6/ 22/ 91. A fish kill occurred in a pond at a private residence. The pond received runoff from a neighboring tobacco field. Analysis of the water in the pond revealed the presence of disulfoton and several other pesticides, including endosulfan. Disulfoton sulfoxide was found in the water at a concentration of 0.32 ppb. Endosulfan had the highest concentration ( 1.2 F g/ L) , and is toxic to fish, but disulfoton cannot be ruled out as a possible cause of death. No tissue analysis was conducted. The certainty index of this incident for disulfoton is possible. ( ( Incident Report No. B0000216­ 025) . 2. Onslow County, NC, 4/ 29/ 91. A fish kill occurred in a pond, which was adjacent to a tobacco field and a corn field. Rain followed the application of pesticide, and more than 200 dead fish were found floating in the pond. Water and soil samples were collected within a week after the incident. Several organophosphorus pesticides, as well as atrazine and napromide, were found in all soil samples taken from around the pipe that ran from the field to the pond, but none of the samples contained detectable disulfoton. The pesticide applicator failed to follow packaging guidance on safe handling of the pesticides. Additionally, the corn and tobacco fields were 62­ 82 feet uphill from the pond, which violates the requirement that these pesticides not be applied within 140 feet of a waterway. The certainty index for this incident is unlikely for disulfoton ( ( Incident Report No. I000799­ 004) . 3. Johnston County, NC, 6/ 12/ 95. A fish kill occurred in a commercial fish pond. Crop fields nearby had been treated with pesticides. Water, soil and vegetation samples were taken and analyzed for a variety of pesticides. Disulfoton, as well as several other pesticides was found in the samples. The level of disulfoton in the vegetation samples was 0.2­ 2.5 ppm. The certainty index for this incident is possible for disulfoton. . ( Incident Report No. I003826­ 002) . 4. Arapahoe County, CO, 6/ 14/ 94. A fish kill occurred following application of Di­ Syston EC. to wheat, which was followed by a heavy rain. Water samples collected contained disulfoton sulfoxide at levels of 29.5­ 48.7 ppb, and disulfoton sulfone at 0.0199­ 0.214 ppb. The wheat field was located several miles from the pond. The volume of run off water raised the level of the pond fifteen feet. In addition to the rapid rise of the water level there was a large mass of sediment and vegetation that may have resulted in a severe drop in the Biological Oxygen Demand levels. The certainty index for this incident is possible for disulfoton. . ( Incident Report No. I001167­ 001) . Some of these incident reports tend to support the conclusions of the risk screens indicating LOCs for acute risk are exceeded. 68 Risk Characterization A. Characterization of the Fate and Transport of Disulfoton i. Water Exposure ( a) Surface Water Disulfoton is likely to be found in runoff water and sediment from treated and cultivated fields. However, the fate of disulfoton and its degradates once in surface water and sediments, and the likely concentrations therein, cannot be modeled with a high degree of certainty since data are not available for the aerobic and anaerobic aquatic degradation rates. Surface water concentrations of disulfoton and total disulfoton residues were estimated by using PRZM3 and EXAMS models using several different scenarios ( barley, cotton, potato, tobacco, and spring wheat) . The large degree of latitude available in the disulfoton labels also allows for a wide range of possible application rates, total amounts, application methods, and intervals between applications. Considering the relatively rapid rate of microbial degradation in the soil ( < 20 day aerobic soil metabolism half­ life) and direct aquatic photolysis, disulfoton parent may degrade fairly rapidly in surface water. However, peak concentrations of disulfoton in the farm pond appear capable of being quite high, with 1­ year­ in 10 peak surface water concentrations of 7.14 to 26.75 F g/ L and 90­ day concentrations of 1.73 to 6.87 µ g/ L for the parent compound. The mean EECs of the annual means of disulfoton ranged from 0.21 to 1.14 µ g/ L. Although there is a lack of some environmental fate data for the degradates, the assessment suggests that the degradates will reach higher concentrations than the parent because they are more persistent and probably more mobile. The estimated peak concentrations for the total disulfoton residues in the farm pond ranged from 15.43 to 58.48 µ g/ L, 90 day average ranged from 12.20 to 35.30 µ g/ L, and the mean of the annual means ranged from 3.89 to 9.32 µ g/ L. Water samples collected at the site of a fish kill in Colorado contained D. sulfoxide at levels of 29.5­ 48.7 µ g/ L, and D. sulfone at 0.0199­ 0.214 µ g/ L. The aerobic soil metabolism studies show that the maximum sulfoxide residues are about 58 percent of total radioactive material, thus, the sulfoxide concentrations suggest that parent disulfoton concentrations could range from 50.8 to 83.9 µ g/ L. The ratio of the disulfoton sulfoxide concentration to the average maximum disulfoton concentration was higher ( 74% ) in the microcosm study ( MRID # 4356501) than in the soil residues ( 58% ) . The estimated drinking water concentrations ( EDWC) for parent disulfoton and total disulfoton residues were also determined using the IR and PCA concepts. The peak concentrations of disulfoton in IR appear capable of being quite high, with 1­ year­ in 10 peak surface water concentrations of 7.13 to 44.20 F g/ L and annual mean concentrations of 0.43 to 2.77 µ g/ L for the parent compound. The mean EECs of the annual means of disulfoton ranged from 0.23 to 1.31 µ g/ L. Although there is a lack of some environmental fate data for the degradates, the assessment suggests that the degradates will reach higher concentrations than the parent because they are more persistent and probably more mobile. The estimated 1­ in­ 10 year peak concentrations for the total disulfoton residues in the IR ranged from 20.83 to 104.92 µ g/ L and annual mean ranged from 5.10 to 16.25 µ g/ L, and the mean of the annual means ranged from 2.55 to 10.42 µ g/ L. These values will also be highly affected by the value selected for PCA. Surface­ water samples were collected in a study to evaluate the effectiveness of Best Management Practices ( BMP) in a Virginia watershed. Approximately half of the watershed is 69 in agriculture and the other half is forested. The detections of parent disulfoton in surface­ water samples ranged from 0.037 to 6.11 µ g/ L and fell within an order of magnitude with the estimated environmental concentrations ( EECs) obtained from the PRZM/ EXAMS models. Surface­ water monitoring by the USGS in the NAWQA ( USGS, 1998) project found relatively few detections of disulfoton in surface water with a maximum concentration of 0.060 µ g/ L. As noted above disulfoton degradates were reported in surface water, when a rainfall event occurred following application to wheat, where fish kills occurred; pesticide residue concentrations ranged from 29.5 to 48.7 µ g/ L for D. sulfoxide and 0.02 to 0.214 µ g/ L ( Incident Report No. I001167­ 001) . A search of the EPA s STORET ( 10/ 16/ 97) data base resulted in the identification of disulfoton residues at a number of locations. Often the values ranged from 0.01 to 100.0 F g/ L with most of the values reported as actual value is less than this value. Thus, , when a value of 100.00 µ g/ L is reported, it is not known how much less than 100.0 F g/ A the actual value is known to be less. Thus there is considerable uncertainty surrounding some of the data in STORET. ( b) Ground Water The SCI­ GROW ( Screening Concentration in Ground Water) screening model developed in EFED was used to estimate disulfoton concentrations in ground water ( Barrett, 1999) . SCI ­ GROW represents a " vulnerable site" , but not necessarily the most vulnerable conditions, treated ( here) with the maximum rate and number of disulfoton applications, while assuming conservative environmental properties ( 90 percent upper confidence bound on the mean aerobic soil half­ life of 6.12 days and an average Koc value of 551 mL/ g) . The maximum disulfoton concentration predicted in ground water by the SCI­ GROW model ( using the maximum rate 4 lb. a. i. / ac and 2 applications ­ potatoes) was 0.05 µ g/ L. The maximum total disulfoton residue concentration predicted in ground water by the SCI­ GROW model for the same scenario is 3.19 µ g/ L ( except 90 percent upper bound on mean half­ life of total residues is 259.6 days) . Ground water monitoring data generally confirms fairly rapid degradation and low mobility in soil, because of the relatively low levels and frequency of detections of parent disulfoton in ground water. There were no ground­ water detections of parent disulfoton in the USGS NAWQA ( USGS, 1998) with a limit of detections of 0.01 or 0.05 µ g/ L, depending upon method. Most of the studies recorded in the PGWDB ( USEPA, 1992) also reported no disulfoton detections. Disulfoton residues ranging from 0.04 to 100.00 µ g/ L were reported for studies conducted in Virginia ( 0.04 to 2.87 µ g/ L) and Wisconsin ( 4.00 to 100.00 µ g/ L) . Of specific interest are areas where the concentrations of parent disulfoton reported in the studies ( VA and WI) exceeded the estimate of 0.05 µ g/ L obtained from EFED' s SCI­ GROW ( ground­ water screening model) model. It should be noted that the Wisconsin data received some criticism which influences the certainty of these detections, no such criticisms or limitations exist for the Virginia study. The major issues, concerning the Wisconsin study ( Central Sands) were that the study may not have followed QA/ QC on sampling and the failure of follow­ up sampling to detect disulfoton residues in ground water as suggested by Holden ( 1986) , have been considered by EFED in the 70 ground­ water quality assessment. The Central Sands of Wisconsin are known to be highly vulnerable to ground­ water contamination. There are regions within the United States that have conditions that are highly vulnerable to ground water contamination and regularly have pesticides detected in ground water which far exceeds values seen elsewhere. Several of these areas are well documented, e. g. , Long Island, Suffolk County, NY and Central Sands in WI. Although, some questions have been levied against the disulfoton detections in Wisconsin, the occurrence of disulfoton at the levels reported cannot be ruled out. There were no detections of disulfoton, disulfoton sulfoxide, and disulfoton in the ground­ water monitoring study conducted in North Carolina. Efforts were made to place the wells in vulnerable areas where the pesticide use was known, so that the pesticide analyzed for would reflect the use history around the well. Seven Christmas tree, one wheat, and two tobacco growing areas were sampled for disulfoton. Limitations of the study include that sites were sampled only twice and the limits of detections were high ( e. g. , > 1.0 µ g/ L) for some of disulfoton analytes. Uncertainties associated with the study include whether two samples from eight wells are adequate to represent the ground­ water concentrations of disulfoton residues, did DRASTIC correctly identify a site' s vulnerability, and were the wells placed down­ gradient of the use areas. The SCI­ GROW model represents a " vulnerable site" , but not necessarily the most vulnerable. Several things should be considered. First, the Virginia and Wisconsin monitoring studies were probably conducted in areas vulnerable to ground­ water contamination. The level of certainty with respect to vulnerability is probably greater for Wisconsin ( relatively less uncertainty) than for Virginia ( relatively more uncertainty ) . The occurrence of preferential flow and transport processes has been also noted in Wisconsin ( and is also possible in Virginia) and may ( speculation) have contributed to the " high" concentrations ( especially in WI) when the initial sampling occurred, but not necessarily in the follow­ up sampling) . The knowledge concerning the disulfoton use in areas in association with the wells is not well known ( high uncertainty) . Some notable limitations of modeling and monitoring are presented elsewhere in this document ( c) Drinking Water The estimates of disulfoton residues in drinking water in an index reservoir adjusted by percent crop area in the watershed is using the coupled PRZM/ EXAMS models. The Agency recommends that the 1­ out­ of­ 10­ year peak values be used the acute surface drinking water level for parent disulfoton, and for chronic levels use either the 90­ day and annual average. The maximum values are: 44.20, 2.77, and 1.31 µ g/ L or the peak, 90­ day mean, and long term mean, respectively. For the total disulfoton residues the peak, 90­ day mean, and long term mean are 104.92, 53.47, and 10.42 µ g/ L. The EDWCs for both parent disulfoton and TDR exceed the DWLOC values estimated by the Agency. The EDWCs values for the parent disulfoton have less uncertainty than the total residue, because there is more certainty surrounding the " estimated" aerobic aquatic metabolism half­ life for the estimated aerobic aquatic half­ life for the total disulfoton residues. It is recommended that the Virginia data be considered in the " quantitative" drinking water assessment for ground water exposure. The Wisconsin data should be noted and addressed more qualitatively. Highly vulnerable areas, such as the Central Sand Plain, do not represent the entire use area and can probably be better mitigated or managed a local or state level. Specifically, it is recommended that the 2.87 µ g/ L be used for acute and chronic exposure from ground water. Based upon the fate properties of 71 disulfoton, the sulfoxide and sulfone degradates ( more persistent and probably more mobile) have a greater probability of being found in ground water. It is likely that ground water and surface water monitoring study ( ies) may be required to better assess the potential exposure from the degradates ( and also parent) in addition to the additional fate data requirements. The registrant disagreed with aquatic dissipation half life of 259 days for total disulfoton residues and cites a microcosm study ( MRID 43568501) and an open literature study ( La Corte et al. , 1994; 1995) which they believe provide data relevant to aquatic dissipation. However, aerobic and anaerobic aquatic metabolism studies which could provide valid model inputs for the degradates disulfoton sulfone and disulfoton sulfoxide have not been submitted. Although the registrant provided the Agency with additional information concerning the fate of disulfoton residues in water under controlled artificial conditions ( MRID 43568501 and LaCorte et al. , 1995) , this information is limited and cannot be used for model inputs. Specifically, these studies provide information concerning the combined effects of hydrolysis, photolysis, and metabolism, with photodegradation contributing significantly to the dissipation. ( An input value for photodegradation was included in the modeling, so this process was incorporated into the dissipation of disulfoton as simulated in the modeling. ) Model input values should be derived from studies which isolate a given process, i. e. , aquatic metabolism, from other routes of dissipation which are considered separately by the model. EFED believes it is not appropriate to use dissipation values, such as those provided in the studies cited by the registrant, as inputs for models which are intended to simulate dissipation from a variety of individual processes. The 259 day half­ life was the upper 90% confidence bound on the mean of total residue half­ lives in aerobic soil metabolism studies ( MRIDs 40042201, 41585101, 43800101) . Because there are no studies for individual degradates from which model inputs can be derived, and because these degradates are of toxicological concern, it is appropriate to use total residue data from the existing studies. The assessment could be refined if studies for the individual degradates were conducted and model inputs could be derived from these studies. The aerobic soil metabolism half­ life is used to estimate the aerobic aquatic half­ life when aerobic aquatic data are not available. OPP has noted that this contributed to the uncertainty of the water assessment. EFED thinks that it is appropriate to use total residues to estimate exposure when there are toxic degradates and when data are not available for the individual degradates. This will contributed to the uncertainty of the water assessment. B. Characterization of risk to nontarget species from Disulfoton Birds: Birds: Acute risk to birds is predicted especially for use patterns involving the 15 G formulation. All modeled application rates and methods for the 15 G formulation exceed the acute risk level of concern for birds, regardless of size. Robins were reported to have been killed following the application of a disulfoton granular product to a tree nursery. Carcasses were found during terrestrial field testing of disulfoton on potatoes, confirming the presumption of acute risk to birds. Since disulfoton is a systemic pesticide, the granular formulations can result in exposure through food items due to uptake by the plant tissues in addition to direct exposure to any unincorporated granules. 72 Foliar applications of liquid formulations present the greatest risk to herbivorous birds. Based on the results of field studies, the residue levels on sampled invertebrates are well below those predicted by EFED' s models, consequently insectivores did not appear to be at risk. However, there is field evidence suggesting that some species are extremely sensitive to disulfoton such that even low concentrations caused mortality. The Swainson s hawk kill appears to be the result of consuming grasshoppers. The hawks crop contents were analyzed and contained residues around 8 ppm. Finally, live blue jays collected 6 to 7 hrs after a pecan orchard was sprayed at 0.72 lbs ai/ A had brain cholinesterase inhibition from 32 to 72% ( White et al. 1990) . Although it is unknown whether these birds would eventually die, Ludke et al. 1975 suggest that inhibition > 50% in carcasses is evidence that death was caused by some chemical agent. Furthermore, it should be recognized that these birds were not only feeding on contaminated food, but also were impacted by dermal and inhalation exposure. Ground applications of liquid formulations to soil, even at 4.0 lb ai/ A would not be expected to cause mortality to birds. Field studies have demonstrated that residue concentration within food items ­ ­ vegetation, invertebrates and seeds ­ ­ in or on the edge of fields are well below those used in screening level assessments and empirically derived from aerial applications. However, in light of the points made in the previous paragraph, some mortality is possible given the possible multiple routes of exposure and hypersensitivity of some species. Chronic risk to herbivorous birds are predicted from exposure to disulfoton when assuming birds are exposed to peak residues for a short period of time or average Fletcher maximum residues for longer periods. Based on reduced hatchling weight, the NOAEC is 37; both for bobwhite quail and mallard duck. Foliar applications and aerially applied soil sprays are estimated to result in 30 day average residues ( based on maximum Fletcher values) on vegetation exceeding the avian chronic level of concern for application rates equal or greater than a single application of 1 lb ai/ A. A residue monitoring study for Di­ Syston 8E in potatoes showed the peak residues on vegetation was 105 ppm after the initial application and 152 ppm following a second application 6 to 10 days later. In the same study, the means of the 3 applications for vegetation in and adjacent to fields were 41 and 14 ppm respectively. The upper bound 95% mean for the vegetation adjacent to the fields was 71 ppm. Therefore even empirically derived residues suggest that the chronic LOC is exceeded on foliage, but not invertebrates for a short time following aerial applications. It is anticipated that since the sulfone and sulfoxide degradates of disulfoton were similar in acute toxicity to parent disulfoton they would have similar chronic NOAECs. These degradates extend the time that total disulfoton residues are available for consumption. Since many of the applications of disulfoton occur in the spring, overlapping the breeding season for most bird species, there is the potential for significant reproductive impacts. Mammals: Acute risk to mammals is expected for use patterns involving the 15 G formulation. All modeled application rates and methods exceed the acute risk level of concern for mammals, regardless of the mammals size. . Small mammal carcasses were found during terrestrial field testing of disulfoton on potatoes, confirming the presumption of acute risk to mammals. Since disulfoton is a systemic pesticide, the granular formulations can result in exposure through food items due to uptake by the plant tissues in addition to direct exposure to any unincorporated granules. Applications of the liquid formulations especially by air can result in mammals being exposed to multiple routes of exposure ­ ­ dermal, inhalation, drinking contaminated water as well as 73 ingestion of contaminated food items. The persistent sulfone and sulfoxide degradates are also toxic to mammals, thereby increasing the potential risk from the application of disulfoton. The registrant has suggested that mammals as well as birds can consume an equivalent of 2 to 3 LD50' s as part of their diet and not be adversely effected. Although this may be true for a population of laboratory test animals, individuals will vary in their sensitivity and can die as a result of inability to avoid predation, secure prey or thermoregulate. Numerous pen studies were conducted with cottontail and jack rabbits exposed to single applications ranging from 1 to 25 lbs ai/ A. While no mortality occurred to cottontails, at the 2 lb ai/ A rate and above jackrabbits suffered 100% mortality. Secondary poisoning did not occur when the jackrabbit carcasses were fed to a number of avian and mammalian carnivores. The apparent difference between the pen study results and the acute mortality predicted in the risk assessment screen is largely due to the possibility that the calculated 1 day LC50s ( ranging from 2 to 12.7 ppm) discounts the rapid metabolism of disulfoton. However, using the demeton LC50 of 320 ppm with its wide ranging confidence interval ( 0 to infinity) also adds uncertainty to the question of disulfoton s acute risk to mammals. Chronic risk to mammals is predicted. As was previously discussed in the above acute and chronic sections for birds, there are several reasons why small mammals are likely to be at even greater risk, not the least of which is the extremely low NOAEC of 0.8 ppm. All modeled and empirically derived residues for all sites exceed the chronic risk level of concern for mammals. Finally, the persistence of the sulfone and sulfoxide degradates, which are also toxic to mammals, increases the likelihood of chronic risk to mammals. Non­ target Insects: Disulfoton and its sulfoxide and sulfone degradates are moderately to highly toxic to bees, however a residual study with honey bees indicated no toxicity for applications up to 1 lb ai/ A. Freshwater Fish: Most of the modeled use patterns did not exceed acute risk levels of concern for freshwater fish. Only the two soil applications at 4.0 lb ai \ A of the liquid formulation exceeded acute risk. All other scenarios exceeded the restricted use and endangered species levels of concern. There is, however, a large amount of variation in freshwater fish species sensitivity to disulfoton, as evidenced in the toxicity data table. The microcosm study included bluegill sunfish. Following the last application of 30 ppb, 10% of the fish died. Several kills of freshwater fish have occurred from applications of disulfoton to different crops­ ­ both as registered uses as well as from misuse. Chronic risk to freshwater fish may occur from uses where single application rates are equal to 4 lb ai/ a and from 3 applications of 1 lb ai/ A. . The single freshwater fish species ( rainbow trout) , for which chronic toxicity data was available, demonstrates significantly less sensitivity to disulfoton than several other species ( bluegill sunfish, bass, guppy) . Therefore, an estimated chronic NOEC value was calculated using the chronic to acute ratio for the rainbow trout, as described earlier. Based on the estimated chronic NOAEC for bluegill, chronic effects would occur from the present uses on tobacco, foliar treatments of potatoes and repeated soil treatments of cotton. Christmas tree plantations were not modeled, however the high application rate ( possibly 47 lbs ai/ A) and sloped land may be a potentially risky site. Freshwater Invertebrates: All modeled crop scenarios exceeded the acute risk level of concern, but the highest risk quotients were less than 10. Again, the risk is further increased due to the toxicity and persistence of the degradates of disulfoton. Microcosm study results 74 indicated that there was recovery of most phyla examined at 3 ppb and long term impacts for most phyla at 30 ppb. Therefore 10 ppb is probably a concentration where short term effects will occur, but recovery can be anticipated. Chronic risk to freshwater invertebrates is predicted to from the use of disulfoton. All of the modeled crop scenarios greatly exceeded the level of concern, sometimes by a factor of several hundred. Invertebrate life­ cycle testing with disulfoton shows that it impacts reproductive parameters ( number of young produced by adults) in addition to survival and growth. The 21 day average EECs for the modeled sites ranged from 4.3 to 17.9 ppb. For the most part these EECs are within the range where recovery was occurring in the microcosm. However there is uncertainty as to how much more reliable the microcosm may be as a predictor of safety. Estuarine and Marine Fish: Although acute and restricted risk levels of concern were not exceeded for estuarine and marine fish, the endangered species level of concern was exceeded for several of the modeled crop scenarios ( cotton, potatoes and wheat) . As was note among the freshwater fish, there can be substantial species differences in sensitivity to disulfoton. Therefore, it is possible that the single marine/ estuarine fish species tested ( Sheepshead minnow) does not fully represent the true range of sensitivity found in a marine or estuarine ecosystem, and this assessment may therefore underestimate the true risk to marine/ estuarine fish. There is also some uncertainty in using the PRZM/ EXAMS EECs derived for ponds to predict exposure to marine/ estuarine organisms. The scenarios modeled are based on hydrologic data for freshwater habitats. The exposure in a marine or estuarine habitat may be higher or lower than that predicted for a freshwater habitat, resulting in higher or lower risk to marine/ estuarine organisms. Chronic risk to estuarine and marine fish is predicted from the use of disulfoton. Both early life­ stage and full life­ cycle testing demonstrated a variety of effects at low levels of disulfoton. Risk quotients based on the early life­ stage toxicity endpoint exceeded the level of concern for cotton, potatoes and tobacco. The highest risk quotients were based on numerous life­ cycle toxicity endpoints ­ ­ fecundity, hatching success and growth; consequently the chronic level of concern was exceeded for all modeled scenarios. Estuarine fish spawning in the upper reaches of tributaries of bays would be a greatest risk. However the likelihood of this risk is uncertain for several reasons: 1) the required time the adults must be exposed to disulfoton in order for their reproductive systems to be effected and 2) the residency time of disulfoton residues in tidal or flowing water. Even if adults are effected after an exposure of only a week, disulfoton may be moved out of an area within several days. Estuarine and Marine Invertebrates: Three of the five modeled scenarios ( cotton, potatoes, and tobacco) resulted in exceedences of the estuarine/ marine invertebrate acute risk level of concern. All the remaining uses exceeded the restricted use level of concern. Similar uncertainty exists as to the validity of the exposure scenario for invertebrates as was just described for estuarine fish. Chronic risk to marine/ estuarine invertebrates is predicted. All of the modeled crop scenarios exceeded the chronic level of concern. The much shorter life cycle of invertebrates as compared to fish, increases the likelihood that only a brief exposure ( a few day or even hours) of adults to disulfoton concentrations around the NOAEC is sufficient to negatively impact reproduction. The degree to which the freshwater microcosm is a predictor of safety for the estuarine invertebrates in highly uncertain. Only the mysid shrimp has been tested and it was acutely and 75 chronically less sensitive than freshwater Daphnia. Therefore, on the basis of this limited data, the chronic impact to estuarine invertebrates not only appears to be lower than for freshwater invertebrates, but is likely to be low. Nontarget Plants: Currently, terrestrial and aquatic plant testing is not required for pesticides other than herbicides except on a case­ by­ case basis. Nontarget plant testing was not required for disulfoton, so the risk to plants could not be assessed at this time. There are phytotoxicity statements on the label, however, as well as some incident reports of possible plant damage from the use of disulfoton, so there is the potential for risk to nontarget plants. Summary of Risk Assessment of North Carolina 24c for use in Christmas Tree Farms Christmas tree farms and the adjacent areas ­ ­ forests and/ or pasture provide excellent habitat for a great variety of wild life. The use of granular disulfoton suggests that there is acute risk to small birds and mammals. The North Carolina Christmas Tree community has submitted numerous testimonials emphasizing the ever increasing numbers and diversity of wild life . This includes game animals such as turkey rearing young amidst the Christmas trees, song birds, rodents and foxes. Although this information is intended to suggest there is little or no negative impact from not only disulfoton, but other pesticides or cultural practices as well, the Agency would prefer to receive documented surveys or research before making a final determination. There were no detections of disulfoton, disulfoton sulfoxide, and disulfoton sulfone in the ground­ water monitoring study conducted in North Carolina by the North Carolina Departments of Agriculture and Environment, Health, and Natural Resources. Seven Christmas tree, one wheat, and two tobacco growing areas were sampled for disulfoton. disulfoton residues. Limitations of the study include that sites were sampled only twice and the limits of detections were high ( e. g. , > 1.0 µ g/ L) for some of disulfoton analytes. Uncertainties associated with the study include whether two samples from eight wells are adequate to represent the ground­ water concentrations of disulfoton residues, did DRASTIC correctly identify a site' s vulnerability, and were the wells placed down­ gradient of the use areas. The use of Disulfoton 15 G in Christmas tree farms at this time cannot be modeled for potential surface water contamination. EFED assumes the estimated concentration for the North Carolina 24 ( c) use pattern ­ ­ 2.75 lbs ai/ A unincorporated ­ ­ may be similar to the values for the single 4.0 lb ai/ A incorporated application of granular disulfoton to tobacco. Based on this assumption there is acute risk to aquatic invertebrates and chronic risk to freshwater fish and aquatic invertebrates. The North Carolina Christmas tree industry submitted two surveys of streams in the Westerns region. The surveys followed a protocol for looking at macro invertebrates to assess the impact of agricultural practices associated with Christmas tree farming. In summary, the two surveys suggests that when conservation measures associated with Christmas tree farming in the Western counties of North Carolina are implemented, there may be only slight, short term impact to aquatic macro invertebrates from disulfoton use. Aquatic macro invertebrates appear to have the capacity to recover from any impact that could be caused by disulfoton use on Christmas trees in Western North Carolina. 76 C. Mitigation The use of disulfoton at single application rates of 1.0 lb ai/ A and greater, and multiple application rates of 0.5 lb ai/ A and greater, poses a high acute risk to birds, mammals, fish, and aquatic invertebrates, as well as to nontarget insects. EFED believes that amending label rates to the lowest efficacious rate as a maximum, as well as restricting the number of applications per year and lengthening the application interval, would reduce acute risk to terrestrial and aquatic organisms. Requiring in­ furrow applications wherever feasible, and eliminating banded applications of granular disulfoton with narrow row spacing, would also reduce the risk to nontarget organisms, especially birds and mammals. Care must be taken, however, so that the likelihood of disulfoton or its degradates leaching to ground water is not increased by these application methods. Eliminating aerial applications of disulfoton and imposing buffer strips around aquatic habitats would reduce the risk to aquatic organisms. Risk to bees and other nontarget insects could be lowered by not applying disulfoton when the insects are likely to be visiting the area. Qualitative comparative ecological risk assessment between present and proposed disulfoton uses. Bayer has proposed the following changes to some use patterns assessed by the Agency that would reduce the ecological risk from Di­ Syston 8E: * cancel aerial applications to cotton and wheat. * cancel foliar applications to cotton. The table reflects additional changes proposed by Bayer. Table 42. Comparison of present and proposed changes in 4 use patterns of Di­ Syston 8E Present Use Proposed Use Rate / Number of Applications / Interval / Incorp. Depth/ method 1 Rate/ Number of Applications / Interval/ Incorp. Depth/ method 1 lb. ai/ A / # / days / inches lb. ai/ A / # / days / inches cotton 1.0/ 3/ 21/ 0/ gs cotton 1.0/ 1/ ­ / 0/ gs potatoes 4.0/ 2/ 14/ 2.5/ gs potatoes 3.0/ 1/ ­ / 2.5/ gs potatoes 1.0/ 3/ 14/ 0/ af potatoes 0.5/ 3/ 14­ / 0/ af wheat 0.75/ 2/ 30/ 0/ gs wheat 0.75/ 1/ ­ / 0/ gs 1 Method of application: f = foliar and s = soil; gs = ground spray, af = aerial spray­ foliar Risk to Birds and Mammals Canceling aerial application to wheat and cotton reduces significantly the potential for exposing 77 edge of field food items and vegetation. Canceling foliar applications to cotton reduces the opportunity for exposure, by reducing the food items that are directly sprayed. As the discussion below explains, field monitoring indicates that ground spray to soil reduces substantially the residues on food items from those residues predicted from the nomograph. Potato aerial foliar at 0.5 lb ai/ acre Biological field testing ( MRID 41359101) suggests that significant acute risk to mammals from foliar sprays is unlikely at a single application of 1 lb ai/ acre or lower. Reducing the potato rate from 1 lb ai/ acre 3 times, to 0.5 lb ai/ acre 3 times, substantially lowers the acute risk to mammals. Wheat, potato and cotton ground spray to soil Field residue monitoring ( MRID 41118901) indicates that residues on food items following ground applications to soil are significantly lower than would be expected from direct application to vegetation. Peak residues following the first of two treatments at 3 lb ai/ acre ( in furrow) ranged from 0.9 ppm ( invertebrates and edge of field vegetation) , to 26 ppm ( potato foliage) . The second treatment at 3 lb ai/ acre side dressing ( 6­ 7 weeks later) resulted in peak residues of 1.8 ( invertebrates) , 44 ppm potato foliage, and 54 ppm ( edge of field vegetation) . The residues from these applications are not only lower than those estimated using the nomograph, but also lower than the field residues resulting from foliar applications. In the foliar residue monitoring study ( 3 aerial applications at 1.0 lb ai/ acre) the peaks were: invertebrates ( 16 ppm) and vegetation ( 154 ppm) . The proposed changes would greatly reduce exposure terrestrial species. Table 43. Comparison of potential acute and chronic risk resulting from proposed changes in 4 use patterns of Di­ Syston 8E for birds and mammals Present Use Birds Mammals Proposed Use Birds Mammals Rate / Number of Apps / Interval / Incorp. Depth/ method 1 ac ch ac ch Rate / Number of Apps / Interval / Incorp. Depth/ method 1 ac ch ac ch lb. ai/ A / # / days / inches lb. ai/ A / # / days / inches cotton 1.0/ 3/ 14/ 0/ gs E Y R Y cotton 1.0/ 1/ ­ / 0/ gs no Y E Y potatoes 4.0 / 2/ 14/ 2.5/ gs R Y A Y potatoes 3.0/ 1/ ­ / 2.5/ gs E Y R Y potatoes 1.0/ 3/ 14/ 0/ af R Y A Y potatoes 0.5/ 3/ 14­ / 0/ af R Y R Y wheat 0.75/ 2/ 30/ 0/ gs E Y R Y wheat 0.75/ 1/ ­ / 0/ gs no Y E Y 1 Method of application: f = foliar and s = soil; g = ground and a = aerial Acute = ac; Chronic = ch Acute risk LOC is exceeded= A; Restricted use LOC is exceeded= R; Endangered Species LOC is exceeded= E; No acute LOC is exceeded= no; LOC for chronic risk is exceeded= Y; LOC for chronic risk is not exceeded= N. Risk to fish and aquatic invertebrates The following table summarizes the results of modeling the proposed new uses. The EECs were reduced from the present registered use patterns: 78 Mean of Annual Means ( µ g/ L) 0.23 0.12 0.57 0.05 Table 44 Tier II Upper Tenth Percentile EECs for Disulfoton Parent based on proposed new maximum label rates and management scenarios for cotton, potatoes, and spring wheat in farm pond. Estimated using PRZM3/ EXAMS. Concentration ( µ g/ L) ( 1­ in­ 10 annual yearly maximum value) Annual Avg. 0.62 0.15 0.62 0.08 90­ Day Avg. 2.42 0.57 2.42 0.28 60­ Day Avg. 3.54 0.84 3.45 0.41 21­ Day Avg. 6.83 1.67 5.20 0.67 96­ Hour Avg. 9.38 2.18 6.62 0.91 Peak 10.31 2.42 7.51 1.02 Disulfoton Application Rate / Number of Apps / Interval / Incorp. Depth/ method 1 lb. ai/ A / # / days / inches 1. 00/ 1/ ­ / 0/ gs 3.00/ 1/ ­ / 2.5/ gs 0.5/ 1/ ­ / 0/ af 0.75/ 1/ ­ / 0/ gs Crop Cotton Potatoes Potatoes Spr. Wheat 1 Method of application: f = foliar and s = soil; g = ground and a = aerial 79 The following tables reflect a qualitative comparative risk assessment for aquatic and estuarine organisms. Table 45. Comparison of potential acute and chronic risk resulting from proposed changes in 4 use patterns of Di­ Syston 8E for freshwater fish and invertebrates Present Use Fish Invertebrates Proposed Use Fish Invertebrates Rate / Number of Apps / Interval / Incorp. Depth/ method 1 a c ch ac ch Rate / Number of Apps / Interval / Incorp. Depth/ method 1 ac ch ac ch lb. ai/ A / # / days / inches lb. ai/ A / # / days / inches cotton 1.0/ 3/ 14/ 0/ gs R Y A Y cotton 1.0/ 1/ ­ / 0/ gs R N A Y potatoes 4.0/ 2/ 14/ 2.5/ gs R Y A Y potatoes 3.0/ 1/ ­ / 2.5/ gs E N A Y potatoes 1.0/ 3/ 14/ 0/ af R Y A Y potatoes 0.5/ 3/ 14­ / 0/ af R N A Y wheat 0.75/ 2/ 30/ 0/ gs R N A Y wheat 0.75/ 1/ ­ / 0/ gs no N R Y 1 Method of application: f = foliar and s = soil; g = ground and a = aerial Acute = ac; Chronic = ch Acute risk LOC is exceeded= A; Restricted use LOC is exceeded= R; Endangered Species LOC is exceeded= E; No acute LOC is exceeded= no; LOC for chronic risk is exceeded= Y; LOC for chronic risk is not exceeded= N. Table 46. Comparison of potential acute and chronic risk resulting from proposed changes in 4 use patterns of Di­ Syston 8E for estuarine fish and invertebrates Present Use Fish Invertebrates Proposed Use Fish Invertebrates Rate / Number of Apps / Interval / Incorp. Depth/ method 1 ac ch ac ch Rate / Number of Apps / Interval / Incorp. Depth/ method 1 ac ch ac ch lb. ai/ A / # / days / inches lb. ai/ A / # / days / inches cotton 1.0/ 3/ 14/ 0/ gs no Y A Y cotton 1.0/ 1/ ­ / 0/ gs no Y A Y potatoes 4.0/ 2/ 14/ 2.5/ gs no Y R Y potatoes 3.0/ 1/ ­ / 2.5/ gs no N R N potatoes 1.0/ 3/ 14/ 0/ af no Y A Y potatoes 0.5/ 3/ 14­ / 0/ af no Y A Y wheat 0.75/ 2/ 30/ 0/ gs no Y A Y wheat 0.75/ 1/ ­ / 0/ gs no N E N 1 Method of application: f = foliar and s = soil; g = ground and a = aerial Acute = ac; Chronic = ch Acute risk LOC is exceeded= A; Restricted use LOC is exceeded= R; Endangered Species LOC is exceeded= E; No acute LOC is exceeded= no; LOC for chronic risk is exceeded= Y; LOC for chronic risk is not exceeded= N. 80 Summary EFED supports the proposed use modifications, and concurs that generally they reduce risk to nontarget organisms to varying degrees. Although there remains the concern for hypersensitive birds and mammals, the acute risk to most birds and mammals is reduced substantially. The greatest risk reduction to fish and aquatic invertebrate are soil applications to potatoes and wheat. There appears to be little changes in acute risk to aquatic organisms from the proposed modifications to cotton and potatoes ( aerial application) . Chronic risk to terrestrial and aquatic organisms are likely to be reduced; but with less certainty, because the duration of exposure required to produce adverse chronic effects in the field are not available. 7. References Balcomb, R. , C. A. Bowen II, D. Wright, and M. Law. 1984. Effects on wildlife of at­ planting corn applications of granular carbofuran. J. Wildl. Manage. 48: 1353­ 1359. Barrett, M. R. 1999. Updated Documentation on the SCI­ GROW Method to Determine Screening Concentration Estimates for Drinking Water Derived from Ground Water Sources. Memorandum From: M. R. Barrett To: J. Merenda. Environmental Fate and Effects Division, Office of Pesticide Programs, U. S. Environmental Protection Agency, Arlington, VA. Barton, A. 1982. Note to Ed Johnson dated 12/ 10/ 82 describing joint effort between EPA/ OPP and Wisconsin Department of Natural Resources to monitor pesticides in ground water per communication with the Wisconsin Department of Natural Resources. 1982. Pesticide Monitoring in Wisconsin Ground Water in the Central Sands Area. Madison, WI Dunning, J. B. , Jr. 1984. Body weights of 686 species of North American birds. Western Bird Banding Association Monograph No. 1. 38 pp. EPA. 1986. Guidance for conducting terrestrial field studies. Evans, J. , P. L. Hegdal, and R. E. Griffith, Jr. 1970. Evaluations of Di­ Syston for jackrabbit control. Denver Wildlife Research Center. ( MRID 413591­ 01) . Fisher, D. L. and L. B. Best. 1995. Avian consumption of blank pesticide granules applied at planting to Iowa cornfields. Environ. Tox. Chem. 14: 1543­ 1549. Harken, J. M. , F. A. Jones, R. Fathulla, E. K. Dzanton, E. J. O' Neill, D. G. Kroll, and G. Chesters. 1984. Pesticides in Groundwater beneath the Central Sand Plain of Wisconsin. Univ. of Wisc. Resources Center Technical Report WIS WRC 84­ 01. Holden, P. W. 1986. Pesticide and Groundwater Quality Issues and Problems in Four States. National Academy Press. Washington, D. C. Howard, P. H. 1991. 1991. Disulfoton. p. 309­ 318. Vol. III. Pesticides Handbook of Environmental Fate and Exposure Data for Organic Chemicals. P. H. Howard et al. , ( ed) . Lewis Publishers, Inc. , Chelsea, MI 81 Johnson et al. 1989. Guthion 35% WP: An Evaluation of Its Effects Upon Wildlife on and Around Apple Orchards in Washington State. MRID 411397­ 01. Jones, R. D. , J. Breithaupt, J. Carleton, L. Labelo, J. Lin, R. Matzner, R. Parker, W. Effland, N. Thurman, and I. Kennedy. 2000. Guidance for Use of the Index Reservoir and Percent Crop Area Factor in Drinking Water Assessments. Draft 3/ 21/ 2000. Environmental Fate and Effects Division, Office of Pesticide Programs, U. S. Environmental Protection Agency, Arlington, VA. La Corte, S. and D. Darcelo. 1994. Rapid Degradation of Fenitrothion in Estuarine Waters. Environmental Sci. and Technol. 28: 1159­ 1163. La Corte, S. , S. B. Lartiges, P. Garrigues, and D. Barcelo. 1995. Degradation of Organophosphorus Pesticides and Their Transformation Products in Estuarine Waters. Environmental Sci. and Technol. 29: 431­ 438. Lenant, David et. al. 1999. Evaluation of Christmas Tree Farming and Cattle Grazing on Water Quality in the New River Basin, Ashe and Alleghany Counties . Submitted in Comments from Jill Sidebottom NC State Extension Service, in Response to the Draft Disulfoton RED ( Unpublished) . Ludke, J. L. , E. F. , Hill, and M. P. Dieter. 1975. Cholinesterase ( ChE) response and related mortality among birds fed ChE inhibitors. Archives of Environmental Contamination and Toxicology 3: 1­ 21. Lyon, L. 1997. Apparent systemic exposure of Swainson' s hawks to the insecticide disulfoton. Abstract of the Proc. 18 th Annual SETAC Meeting. Mostaghimi, S. et al. 1989. Watershed/ Water quality monitoring for evaluating BMP effectiveness ­ Nomini Creek Watershed. Report N­ P1­ 8811. Agricul. Engineer. Dept. Virginia Tech. NCIWP, 1997. The Interagency Study of the Impact of Pesticide Use on Ground Water in North Carolina. Prepared for North Carolina Pesticide Board by The Interagency Work Group. March 4, 1997. North Carolina Department of Agriculture, Raleigh, NC. Patuxent Wildlife Research Center. 1993. Swainson Hawk Deaths, Young County, Texas. ECDMS Working Catalog # 2040019. In response to submission of Regional Study ID 93R2HFO. ( Unpublished) . Sheeley et al. 1989. Guthion 35% WP: An Evaluation of Its Effects Upon Wildlife on and Around Apple Orchards in Michigan MRID 411959­ 01. Sidebottom, J. et al. 2000. Evaluation of the effect of Christmas tree production in western North Carolina on surface water quality . Submitted in Comments from Jill Sidebottom, NC State Extension Service, in Response to the Draft Disulfoton RED ( Unpublished) . 82 USEPA. 1999. Memorandum. Draft: Standardization of Spray Drift Input Values for PRZM/ EXAMS Modeling, dated 4/ 13/ 99) from Water Quality Technology Team, Environmental Fate and Effects Division, Office of Pesticide Programs, USEPA. Arlington, VA. USEPA. , 2000. DP Barcode 267486 EPA Review of NCIWP, 1997. The Interagency Study of the Impact of Pesticide Use on Ground Water in North Carolina. Prepared for North Carolina Pesticide Board by The Interagency Work Group. March 4, 1997. North Carolina Department of Agriculture, Raleigh, NC and its relevance to the disulfoton. White, D. H. and J. T. Seginak. 1990. Brain Cholinesterase inhibition in Songbirds from Pecan Groves Sprayed with Phosalone and Disulfoton. Journal of Wildlife Diseases 26( 1) : 103­ 106. 83 APPENDIX I: USE OF DISULFOTON ( LB. AI/ YR) BY CROP AND BY STATE Crop Percent of market lb ai/ yr ( Doane s Agriculture Service data) lb ai/ yr ( estimate provided by BEAD, based on market information) Cotton 61 428,000 420,000­ 840,000 Wheat 16 123,000 180,000­ 354,000 Barley 7 49,000 29,000­ 77,000 Potatoes 7 50,000 120,000­ 195,000 Peanuts 5 27,000 47,000­ 106,000 Cole crops 2 14,000 no information Corn 1 4,000 36,000­ 73,000 Tobacco 1 4,000 64,000­ 128,000 State Percent of market lb ai/ yr ( based on total ai/ yr of 1,700,000 lb) California 16 272,000 Louisiana 11 187,000 Kentucky 10 170,000 Missouri 8 136,000 Arkansas 8 136,000 Texas 7 119,000 Alabama 7 119,000 Virginia 6 102,000 North Carolina 5 85,000 Maine 4 68,000 Mississippi 4 68,000 Utah 4 68,000 Georgia 3 51,000 Michigan 2 34,000 Ohio 2 34,000 84 Arizona 1 17,000 New Mexico 1 17,000 85 APPENDIX II: Chemical Structure of Disulfoton 86 APPENDIX III The monitoring data obtained from STORET on October 16, 1997 are summarized in Table 1. The majority of samples had low levels ( < 16 µ g/ L) of disulfoton residues. However, there were indications of some high concentrations ( may be a reflection of how the data were reported) as the disulfoton concentrations in the monitoring were not always known. This is because the detection limit was not adequate ( extremely high) or specified, and/ or the limit of quantification was not stated or extremely high. Disulfoton concentrations were simply given as less than a value. Therefore, considerable uncertainty exists with respect to the monitoring data ( especially the STORET data) . Limitations in Monitoring Monitoring data is limited by the lack of correlation between sampling date and the use patterns of the pesticide within the study s drainage basin. Additionally, the sample locations were not associated with actual drinking water intakes for surface water nor were the monitored wells associated with known ground water drinking water sources. Also, due to many different analytical detection limits, no specified detection limits, or extremely high detection limits, a detailed interpretation of the monitoring data is not always possible. 87 Table 1. Summary of disulfoton detections in STORET . Type of Water Body # of Samples Analytical Method Disulfoton Concentration 1 ( range µ g/ L) Stream 1940 39010/ 39011 2 0.00­ 16.00 253 81888 3 0.00­ 100.00 39 82617 4 0.05­ 1.00 5164 82677 5 0.00­ 0.21 Lakes 270 39011 0.01­ 0.10 2 81888 0.05­ 0.14 20 82617 1.00­ 1.00 52 82677 0.00­ 0.10 Springs 24 39011 0.01­ 0.10 15 81888 0.05­ 100.00 134 82677 0.008­ 0.060 Reservoirs 2 81888 0.10­ 0.20 Estuary 4 39011 0.01 1 82677 0.02 Canals 2 39011 0.5 215 81888 0.03­ 0.3 Wells 383 39010 1.00­ 100.00 951 39011 0.01­ 1.00 3108 81888 0.00­ 250.00 44 82617 0.03­ 1.00 2559 82677 0.00­ 0.14 1 Value reported as known to be less than reported . 2 39010/ 39011 Flame Photometer Whole Water: disulfoton/ Di syston 3 81888 Disulfoton Whole Water 4 82617 Disulfoton Total Recoverable whole water 5 82677 Disulfoton filtered 0.07 um Total Recoverable whole water 88 Appendix IV Environmental Fate and Chemistry Study Identification Blumhorst, R. B. , and P. Y. Yen. Aerobic Soil Metabolism of [ Ethylene­ 1­ 14 C Disulfoton. ] Bayer Report 106944, Study No. D1042103. Unpublished study performed by EPL Bio­ Analytical Services. , Kansas City, Missouri. Forbes, A. D. 1988. Uptake, depuration, and bioaccumulation of 14 C Di­ Syston to bluegill sunfish ( Lepomis macrochirus) . Performed by Analytical Biochemistry Laboratories; Submitted by Mobay Corp. Received by HED on 2/ 10/ 88. MRID# 40471106. Grace, T. J. , K. S. Cain, and J. L. Delk. 1990. Dissipation of disulfoton in California soils. Performing Laboratory Project IDs: ML022101, 89.023 Plot 24, 89.032 Plot 10, 892010.1­ 6K, M, 169W. Submitting Laboratory Project ID: D1830089R01. Mobay Report No. 100158. Unpublished study performed by Plant Sciences, Inc. , Watsonville, CA; Siemer and Associates, Inc. , Fresno, CA and Pharmacology and Toxicology Research Laboratory ­ West, Richmond, Ca. Submitted by Mobay Corp. , Kansas City, Mo. Graney, R. L. , 1989. MRID­ 43042501. Supplemental submission containing raw data for: uptake, depuration and bioconcentration of 14 C Di­ Syston to bluegill sunfish ( Lepomis macrochirus) . Mobay Project ID: 95078­ 1. Unpublished study performed by Analytical Biochemistry Lab. , Columbia, MO and submitted by Miles, Inc. , Kansas City, MO. Hamman, S. D. , G. Olson, J. Howard, and L. J. Lawrence. Volatility of Di­ Syston under field conditions. Pharmacology and Toxicology Research Lab. , Submitted by Mobay Corp. , Received by HED on 2/ 10/ 88. Accession No. 40471105. Hanlon, C. M. , and K. S. Cain. 1987. MRID­ 43060101. Identification of residues from bluegill sunfish exposed to 14 C Di­ Syston. Laboratory Project ID: DI­ 03­ A; Mobay Project ID: 95076. Unpublished study performed by Analytical Biochemistry Laboratories , Columbia, MO, and Mobay Corporation, Stilwell, KS. Submitted by Mobay Corp. Stilwell, KS. Howard, P. H. ( Ed) . 1991. Handbook of Environmental Fate and Exposure Data For Organic Chemicals. Vol. 3. Pesticides. Lewis Publishers. , Chelsea, MI. Jackson, A. B. , L. O. Ruzo, and L. J. Lawrence. Soil surface photolysis of Di­ Syston in natural sunlight. Performed by Pharmacology and Toxicology Research Laboratory; Submitted by Mobay Corp. , Received by HED on 2/ 10/ 88. EPA Accession No. 40471103. Kasper, A. M. , B. A. Shadrick, K. S. Cain, and D. L. Green. 1992. Anaerobic aquatic metabolism of 14 C disulfoton. Miles Study No. D1042401; Miles Report No. 103945. Unpublished study performed and submitted by Miles, Inc. , Kansas City, MO. Kesterson, A. B. , Ruzo, L. O. , and Lawrence, L. J. Photochemical degradation of Di­ Syston in aqueous solutions under natural sunlight. Performed by Pharmacology and Toxicology Research Submitted by Mobay Corporation. Received by HED on 2/ 10/ 88. EPA Accession 89 No. 40471102. Leimkuehler, W. M. , and J. S. Thornton. 1986. Hydrolysis of Di­ Syston in Aqueous Sterile Buffer Solutions. Mobay Report 68943. Leimkuehler, W. M. & S. K. Valdez. 1989. Soil Adsorption and Desorption of 14 C Di­ Syston. Unpublished Bayer Report No. 99721, 39 pages. Laboratory Report No. DI182101. MRID # 443731­ 03. Olson, G. L. , and L. J. Lawrence. 1990. Aerobic metabolism of 14C Di­ Syston in sandy loam soil. PTRL Report No. 1229; Project No. 320. Unpublished study performed by Pharmacology and Toxicology Research Lab. , Lexington, Ky. , and submitted by Mobay Corp. , Stillwell, KS. , MRID­ 41585101. Obrist, J. J. , 1979. Leaching Characteristics of Aged Di­ Syston Soil Residues. Mobay Report No. 67485 ­ MRID ­ 00145470. Supplemental­ No DER, only a memorandum with very little information. Puhl, R. J. and Hurley. 1978. Soil Adsorption and Desorption of Di­ Syston­ Mobay Report # 66792. No DER was written, but previous a reviewer approved the Freundlich K values. MRID # 00145469. Schmidt, J. , T. J. Anderson, and D. G. Dyer. 1992. Laboratory volatility of disulfoton from soil. ABC Final Report No. 40259. Miles Study No. D1152101. Miles Report No. 103907. Unpublished study performed by ABC Laboratories Inc. , Columbia, MO, and submitted by Miles Inc. , Kansas City, MO. 90 91 APPENDIX V: ENVIRONMENTAL FATE DATA REQUIREMENTS FOR Chemical No: 032501 Disulfoton Guideline Use Pattern Does EPA Have MRID No. More Data Data to Satisfy the Required? Guideline Req. ? 158.290 ENVIRONMENTAL FATE Degradation Studies­ Lab: 161­ 1 Hydrolysis 1,2,3 Yes 00143405 No 161­ 2 Photodegradation In Water 1, 2,3 Yes 40471102 No 161­ 3 Photodegradation On Soil 1,2,3 Yes 40471103 No Metabolism Studies­ Lab: 162­ 1 Aerobic Soil 1,2,3 Yes 43800101,40042201,41585101 No 162­ 2 Anaerobic Soil 1,2,3 No No 162­ 3 Anaerobic Aquatic 1,2,3 No ( 43042503 2 ) Yes 162­ 4 Aerobic Aquatic 1,2,3 No No Mobilit Studies: : 163­ 1 Leaching­ Adsorption/ Desorp. 1, 2,3 Yes 44373103,00145469,43042500,00145470 No 163­ 2 Volatility ( Lab) 1, 2,3 Yes 42585802 No Dissipation Studies­ Field: 164­ 1 Soil 1,2,3 Yes 43042502 No Accumulation Studies: 165­ 4 In Fish 1,2,3 Partially 43042501,43060101,40471106,40471107 No Ground Water Monitoring Studies: 166­ 1 Small­ Scale Prospective 158.440 Spra Drift: : 201­ 1 Droplet Size Spectrum 202­ 1 Drift Field Evaluation FOOTNOTES: 1 Submitted study was classified as supplemental and must be repeated in order to fulfill Guidelines requirements 92 Appendix VI: Ecological Effects Data Table Generic Data Requirements for Disulfoton ( parent compound) as of 02/ 02/ 98 Data Requirement Composition Does EPA MRID Citation Were Data Have Data Submitted to Satisfy Under FIFRA Data Req? 3( c) ( 2) ( B) ? _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 158.490 Wildlife and Aquatic Organisms AVIAN AND MAMMALIAN TESTING 71­ 1 Avian oral LD50 TGAI Yes 25525,00095655, No GS0102700,05008363,425858­ 03 71­ 2 Avian dietary LC50 TGAI Yes 0094233,00058746,120480 No 71­ 3 Wild Mammal Toxicity TGAI No Yes 71­ 4 Avian Reproduction TGAI Yes 43032501, 43032502 No 71­ 5 Simulated and actual field testing­ mammals and birds TEP Partially 00095658,00095657 No AQUATIC ORGANISM TESTING 72­ 1 Freshwater fish LC50 a. Warmwater TGAI Yes 40098001,00068268,00003503 No b. Warmwater TEP Yes 229299, 00068268 1 No c. Coldwater TGAI Yes 40098001,00068268,00003503 No d. Coldwater TEP Yes 00068268 2 No 72­ 2 Freshwater Invertebrate EC50 a. TGAI Yes 00003503,00143401 No b. TEP No No c. Degradate Yes 425851­ 09,42585­ 12 No 72­ 3 Marine/ Estuarine Acute LC50 a. fish TGAI Yes 400716­ 01 No b. mollusk TGAI Yes 400716­ 02 No c. shrimp TGAI Yes 400716­ 03 No d. fish TEP No No e. mollusk TEP No No f. shrimp TEP No No 93 72­ 4a Fish early life stage TGAI Yes ( freshwater) 419358­ 01 No ( marine­ estuarine) Yes 426290­ 01 No b Aquatic invert. life­ cycle TGAI ( freshwater) Yes 419358­ 02 No 419358­ 01 419358­ 02 marine­ estaurine) Yes 436109­ 01 No 72­ 5 Fish Life Cycle TGAI ( marine­ estuarine) Yes 43960501 No 72­ 6 Aquatic organism TGAI Yes ( See Environmental fate guideline 165­ 1) No accumulation 72­ 7 Simulated or TEP Yes actual field testing ­ aquatic organisms 158.150 PLANT PROTECTION ­ Nontarget Area Phytotoxicity TIER I 122­ 1 Seed seedling emergence TGAI No Yes 122­ 1 Vegetative vigor TGAI No Yes 122­ 2 Aquatic plant growth TGAI No No TIER II 123­ 1 Seed germ. / seedling emergence TGAI No No 123­ 1 Vegetative vigor TGAI No No 123­ 2 Aquatic plant growth TGAI No No TIER III 124­ 1: Terrestrial plant field testing TEP No No 124­ 2: Aquatic plant field testing TEP No No 158.590 NONTARGET INSECT TESTING ­ POLLINATORS 141­ 1 Honeybee acute contact toxicity TGA Yes 00066220,05001991,05004151 No 141­ 2 Honeybee toxicity TEP Yes 0163423 No of residues 141­ 5 Field testing for pollinators TEP No No _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 94 Appendix VII. Summary of Maximum Percent Crop Areas ( without Land Use coverage) CROP MAXIMUM PERCENT CROP AREA ( as a decimal) HYDROLOGIC UNIT CODE ( 8­ DIGIT HUC) STATE Wheat 0.56 09010001 N. Dakota Cotton 0.20 08030207 Mississippi Soybeans­ Cotton 0.49 ( 0.31 soybeans, 0.18 cotton) 08020204 Missouri All Agricultural Land 0.87 10230002 Iowa Note that there is an entry for All Agricultural Land in Appendix 2, , Table 1. This is a default value to use for crops for which no specific PCA is available. It represents the largest amount of land in agricultural production in any 8­ digit hydrologic unit code ( HUC) watershed in the continental United States. 95 Appendix VIII. PRZM input parameters where modifications were necessary for the Index Reservoir ( IR) Scenario PRZM variable Farm Pond Value IR Scenario Definition AFIELD 10 ha 172.8 ha area of plot or field HL 374 m scenario specific 464 1 m or 600m Hydraulic length DRFT 0.01 ground 0.05 aerial 0.064 ground 0.16 aerial Spray drift 1 This value changed between versions Guidance document and modeling of data during the development of the Guidance document. The PRZM Input file and the EXAMS environment ( index reservoir) were matched. As noted above in above table, the value for the variable HL changed between Guidance document versions and modeling. The HL ( hydraulic length) value changed from 464 m to 600. The PRZM input files were in agreement with whichever environment or index reservoir that was used.

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1 PC Code: 32501 DP Barcode 267486 MEMORANDUM TO: Christina Scheltema PM Team Reviewer Betty Shackleford Chief Reregistration Branch 3 Special Review and Registration Branch 7508C FROM: James K. Wolf Soil Scientist THRU: Arnet Jones Chief Environment Risk Branch 3 Environmental Fate and Effects Division 7507C RE: The Interagency Study of the Impact of Pesticide Use on Ground Water in North Carolina. March 4, 1997 (Ground ­water contamination from disulfoton use on Christmas trees in NC was the only topic considered in this assessment). DATE: July 28, 2000 Conclusions: Based upon this monitoring study and OPP's understanding of the use practices of disulfoton (e. g., hand broadcast below a tree) associated with Christmas tree production in North Carolina, no additional ground­ water monitoring for disulfoton resulting from Christmas tree production is necessary at this time. This recommendation could change depending upon the results of other monitoring efforts (e. g., NAWQA) associated with other uses (e. g., high frequency of detections) or concern for degradates not considered in the monitoring study. Detection limits or limits of quantification should be lower in any broader base sampling. There were no detections of disulfoton, disulfoton sulfoxide, and disulfoton in the ground­ water monitoring study conducted in North Carolina. Efforts were made to place the wells in vulnerable areas where the pesticide use was known, so that the pesticide analyzed for would reflect the use history around the well. Limitations of the study include that sites were sampled only twice and the limits of detections were high (e. g., > 1.0 µg/ L) for some of disulfoton analytes. Uncertainties associated with the study include whether two samples from eight wells are adequate to represent the ground­ water concentrations of disulfoton residues, did 2 DRASTIC correctly identify a site's vulnerability, and were the wells placed down­ gradient of the use areas. General: The North Carolina Departments of Agriculture (NCDA) and Environment, Health, and Natural Resources (DEHNR) conducted a cooperative study under the direction of the North Carolina Pesticide Board. The purpose of the statewide study was to determine if the labeled uses of pesticide products were impacting the ground water resources in North Carolina. The study was conducted in two phases. In phase I, 55 wells in the DEHNR Ground Water Section's ambient monitoring network representing the major drinking water aquifers of the state were sampled at least twice and analyzed for selected pesticides. In phase II, 97 cooperator monitoring wells were installed and subsequently sampled at least twice in 36 counties across the North Carolina. Sites for the cooperator monitoring wells were chosen based on an evaluation of the vulnerability of ground water to risk of contamination from the use of pesticides. Monitoring wells were located adjacent to and down­ gradient from areas where pesticides were reported to have been applied (within 300 feet) during the previous five years. Wells were constructed so that the shallowest ground water could be collected for analysis. The objective of these criteria was to use a scientific method for determining monitoring well locations so that the results could be used as an early indication of the potential for problems associated with pesticides leaching to ground water. The study authors make the following statement, "Results cannot be interpreted as representing the quality of ground water near pesticide use areas statewide because the study methods targeted areas of highly vulnerable ground water". The study used tools and information available at the time of the study to identify vulnerable locations for well placement. This included statewide agricultural data from the N. C. Agricultural Statistics which were used to identify crop growing areas, the USEPA DRASTIC method (Aller et al., 1987) was used to locate the most vulnerable locations in the target crop growing areas, and local county agents of the USDA Natural Resources Conservation Service (NRCS) helped identify cooperators­ farmers for placement of wells. The Pesticide Study staff and county agents also met with the cooperators to obtain pesticide use information. Other studies have shown that DRASTIC is not as good a method to identify vulnerable areas as hoped. The study appeared to QA/ QC practices. Wells were sampled in two rounds in phase II, approximately six months apart. If a chemical was detected in any well, a follow­ up sample was collected from the same well and analyzed for the same chemical. Seven of the 55 ambient monitoring wells in phase I had pesticide residues detected in at least one sample collected. In the cooperator phase (II) of the study, 26 of 97 wells had pesticide 3 detected in at least one water sample collected from each well. None were disulfoton residues. Disulfoton: Disulfoton, disulfoton sulfone, and disulfoton sulfoxide represented three analytes measured in the study. Two different labs conducted the analysis of water samples. The stated limits of quantification were 1.0 µg/ L, 2.3 µg/ L, and not established for disulfoton, disulfoton sulfone, and disulfoton sulfoxide, respectively for the Division of Environmental Management Laboratory. The second lab's limits of quantification were 0.3 µg/ L, 3.8 µg/ L, and 0.38 for disulfoton, disulfoton sulfone, and disulfoton sulfoxide, respectively for the North Carolina Department of Agricultural Laboratory. Disulfoton residues were monitored for in five North Carolina counties, Alleghany, Ash, Beaufort, Madison, and Robeson. Seven wells were located in Christmas Tree growing areas, one in wheat growing county, and 2 in tobacco areas. The breakout of wells sampled and analyzed for disulfoton in each county by crop are summarized in the Table 1. There were no detections of disulfoton residues in any samples collected in the study. Simazine and lindane were detected at two of the Christmas tree sites Table 1. Summary of sites samples for disulfoton or Christmas tree growing area in North Carolina. County Crop Disulfoton Use Ground Water Detection Alleghany Christmas Trees no no Ash Christmas Trees no no Ash Christmas Trees yes no Ash Christmas Trees yes no Alleghany Christmas Trees yes no Alleghany Christmas Trees yes no Ash Christmas Trees yes no Beaufort Wheat yes no Madison Tobacco yes no Robeson Tobacco yes no Aller, L. T., T. Bennett, J. H. Lehr, R. J. Petty, and G. Hackett. 1987. DRASTIC: A Standardized 4 System for Evaluating Ground Water Pollution Potential Using Hydrogeologic Setting. USEPA Document # EPA/ 600/ 2­ 85­ 018.

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM March 25, 2002 SUBJECT: Corrected version of EFED's eco portion of SRRD's April 2001 Disulfoton IRED FROM: Henry Craven, Biologist, ERB 3, EFED (7507C) THRU: Kevin Costello, Acting Branch Chief ERB 3, EFED (7507C) TO: Betty Shackleford, PM 53 Christina Scheltema, PM Team Reviewer Michael Goodis Reregistration Branch 3 Special Review and Reregistration Division (7508W) This memo serves to transmit the corrected version of EFED's 8/ 20/ 01 modification of EFED's Eco portion of SRRD's April 2001 Disulfoton IRED. Included is the output files for a number of runs of the terrestrial exposure model­­ FATE5. 2 B. Environmental Risk Assessment A summary of the Agency's environmental risk assessment is presented below. For detailed discussions of all aspects of the environmental risk assessment, see the document, Preregistration Eligibility Decision for Disulfoton, dated January 13, 2000, available in the public docket and the most recent amendment to this document, dated September 5, 2000. The environmental risk assessment for disulfoton has been refined with new information submitted during phases 3 and 5 of the public participation process. This information included proposed changes to the disulfoton registration, such as reductions in the rate and frequency of application, to mitigate risks, as well as public comments on environmental risk and drinking water. 1. Environmental Fate and Transport In soil, disulfoton is not expected to undergo significant hydrolysis or volatilization. Disulfoton parent is photochemically degraded rapidly by sunlight on soil and in water where light can penetrate. Disulfoton is metabolized or oxidized in soil to the corresponding sulfoxide and sulfone degradates. Degradation of disulfoton parent in soil does not appear to follow firstorder kinetics, but the half life is less than 6 days. Field dissipation studies confirm that disulfoton does not persist in the environment. EPA does not have data on the anaerobic metabolism of disulfoton. Disulfoton is not considered mobile under convective­ dispersive processes, but it has been detected in groundwater monitoring conducted in highly vulnerable areas. Disulfoton degrades in the environment. The major degradates, disulfoton sulfone and sulfoxide, are more persistent and mobile than the parent. As much as 35% of the applied disulfoton remained in soil as disulfoton sulfone after 367 days. Thus the degradates appear to be much more persistent than parent in soil. The other degradates were either not identified or occurred at much lower concentrations. However, the Agency is concerned that the sulfoxide and sulfone degradates have a high potential to reach ground and surface water. In field testing, degradates were detected at a depth of 18 inches, indicating potential mobility. The Agency has limited data regarding the persistence of the degradates and lacks the absorption/ desorption data necessary to confirm the mobility of the degradates. Aerobic and anaerobic aquatic metabolism studies are required for the parent and degradates. A study on the mobility and leaching potential of the degradates is also required. 2. Water Resources Assessment The water resources assessment is summarized earlier in this document. The surface water EECs shown in Table ­ were used to assess potential drinking water exposure to disulfoton. The drinking water assessment has been refined to include the percent crop area 3 factor and the index reservoir. However, the ecological water resources assessment does not include the refinements mentioned above. The Agency's current policy is to include these refinements in the drinking water assessment but not in the ecological risk assessment because the " unrefined" farm pond on the edge of field scenario is thought to better represent the conditions for ecological exposure. For more information, see Preregistration Eligibility Document for Disulfoton, September 5, 2000. 3. Ecological Risk Assessment The Agency's ecological risk assessment compares toxicity endpoints from ecological toxicity studies to estimated environmental concentrations based on environmental fate characteristics, pesticide use, and/ or monitoring data. The Agency first assesses the acute and chronic toxicity to each of four groups of nontarget animals. Acute toxicity is expressed as follows: ­EC50 ( invertebrates), ­LC50 (fish and birds), and ­LD50 (birds and mammals) Chronic toxicity is expressed as follows: ­NOAEL or NOAEC for avian and mammal reproduction studies, and either ­The NOAEL for chronic aquatic studies, or ­The Maximum Allowable Toxicant Concentration (MATC). To estimate potential ecological risk, EPA integrates the results of exposure and ecological toxicity studies using the quotient method. Risk quotients (RQs) are calculated by dividing exposure estimates by ecological toxicity values, both acute and chronic, for various species. These RQ values are compared to levels of concern (LOCs), which provide an indication of the relative risk the particular pesticide and/ or use may pose for nontarget organisms. In general, the higher the RQ the greater the concern. The LOC indicates whether a chemical, when used as directed, has the potential to cause undesirable effects on nontarget organisms. When the risk quotient exceeds the LOC for a particular category, the Agency presumes a risk of concern to that category. The LOC's and the corresponding Risk presumptions are presented in the following table: Table 9. Levels of Concern (LOCs) and Associated Risk Presumption IF... THEN the Agency presumes... Mammals and Birds The acute RQ > LOC of 0.5, Acute risk The acute RQ >LOC of 0.2, Risk that may be mitigated through restricted use The acute RQ > LOC of 0.1, Acute effects may occur in Endangered species The chronic RQ > LOC of 1 Chronic risk and Chronic effects may occur in Endangered species IF... THEN the Agency presumes... 4 Fish and Aquatic Invertebrates The acute RQ > LOC of 0.5 Acute risk The acute RQ > LOC of 0.1 Risk that may be mitigated through restricted use The acute RQ >LOC of 0.05 Acute effects may occur in Endangered species The chronic RQ > LOC of 1 Chronic risk and Chronic effects may occur in Endangered species Plants The RQ > LOC of 1 Acute risk The RQ > LOC of 1 Endangered plants may be affected No separate criteria exist for restricted use or chronic effects for plants. Risk characterization provides further information on the likelihood of adverse effects occurring by considering the use pattern of the pesticide; its fate in the environment; the species and populations of organisms potentially at risk, their spatial and temporal distributions; and the nature of the effects observed in toxicity studies. a. Toxicity of Disulfoton to non target organisms The Agency has a fairly robust toxicity database for disulfoton and the two primary degradates, disulfoton sulfoxide and disulfoton sulfone. The following table contains the toxicity values used in the terrestrial animal risk assessment Table 7. Toxicity endpoints used in assessing risk of terrestrial organisms for disulfoton Species Test Type Results (ppm ai) Toxicity Classification Source of Data Japanese quail sub acute dietary LC50= 333 highly toxic 0034769 Northern bobwhite quail sub acute dietary LC50) = 544 moderately toxic 0094233 Northern bobwhite quail sub acute dietary LC50 (sulfone metabolite) = 558 moderately toxic 42585106 Northern bobwhite quail sub acute dietary LC50 (sulfoxide metabolite) = 456 highly toxic 42585105 Mallard duck acute oral LD50= 6.54 mg ai/ kg very highly toxic 00160000 Mallard duck reproduction NOAEC= 37 LOAEC= 80 (decreased adult and hatchling body weight) N/ A 43032502 Species Test Type Results (ppm ai) Toxicity Classification Source of Data 5 Laboratory rat acute oral LD50= 1.9 mg ai/ kg very highly toxic 072293 Laboratory rat acute oral LD50 (sulfone metabolite) =11.24 mg /kg highly toxic 0071873 Laboratory rat acute dietary 1­ day LC50 1 (2 to 12.7ppm) highly to very highly toxic N/ A Laboratory rat 2­ generation reproduction NOAEL= 0.8 LOAEL= 2.4 (decreased litter size and pup survival) N/ A 261990 Honey bee acute contact LD50 = 4.1 ug ai/ bee moderately toxic 05004151 Honey bee acute contact LD50 (sulfone metabolite) = 0.96 ug/ bee highly toxic 42582902 Honey bee acute contact LD50 (sulfoxide metabolite) = 1.11 ug /bee highly toxic 42582901 Honey bee acute foliar residue 2 RT25 (8 EC) < 3hrs at 1.0 lb ai/ A N/ A 0163423 1 one­ day LC50 = LD50 (mg/ kg) / proportion of body weight consumed. The mammalian LD50 of 1.9 mg/ kg was used to estimate 1­ day LC50s ranging from 2 ppm for a 15 gram herbivore (consumes 95%) to 12.7 ppm for a 1000 gram granivore (consumes 15%) 2 RT25 (residual time) time required to reduce mortality of caged bees to field weathered spray deposits. 6 Table 8. Toxicity endpoints used in assessing risk of aquatic organisms for disulfoton Freshwater Species* Test Type Results (ppb ai) Toxicity Category Source of Data Bluegill Acute LC50= 39 very highly toxic 00068268 Bluegill Acute LC50 (sulfone metabolite) =112 highly toxic 42585108 Bluegill Acute LC50 (sulfoxide metabolite) =188 highly toxic 42585107 Bluegill Early Life Stage** estimated NOAEC = 4.6 Extrapolated from 41935801 Glass shrimp Acute EC50= 3.9 Very highly toxic 40094602 Water flea Life Cycle NOAEC= 0.037 N/ A 41935802 Water flea Life Cycle NOAEC (sulfone metabolite) =0.14 N/ A 43738001 Water flea Life Cycle NOAEC (sulfoxide metabolite) = 1.53 N/ A 43738002 Marine Species* Sheepshead minnow Acute LC50= 520 highly toxic 40228401 Sheepshead minnow Acute LC50 (sulfone metabolite) = 1060 moderately toxic 44369901 Sheepshead minnow Acute LC50 (sulfone metabolite) = 11300 slightly toxic 44369902 Sheepshead minnow Early Life Stage NOAEC= 16.2 N/ A 42629001 Sheepshead minnow Full Life Cycle EC05= 0.96*** N/ A 43960501 Eastern Oyster Acute EC50= 720 highly toxic 40228401 Brown shrimp Acute EC50= 15 very highly toxic 40228401 Mysid Life Cycle EC05= 2.35*** N/ A 43610901 * The species listed and used in risk assessment were selected from the toxicity data because they seemed to represent a distribution of sensitivity. ** An early life stage study was not conducted with bluegill, but was derived from a rainbow trout study (MRID 41935801). 7 b. Environmental Exposure to Disulfoton EPA uses models to estimate exposure of nontarget plants and animals to disulfoton. For terrestrial birds and mammals, the Agency first estimates initial levels of Disulfoton residues on various food items consumed by wildlife using the Fletcher nomogram( MRID # (45374901) followed by a first order decline model such as FATE5. This assessment was further characterized after reviewing one residue monitoring study conducted in potatoes.. Based on the results of this study a foliar dissipation half life of 3.3 was derived and was subsequently used to estimate terrestrial exposure using the FATE5 model. The following table shows predicted residues immediately after application on terrestrial food items that result from a single application of disulfoton calculated from Hoerger and Kenaga (1972) as modified by Fletcher et al. (1994): Table 9: Estimated Environmental Concentrations on Avian and Mammalian Food Items (ppm) Following a Single Application at 1 lb ai/ A Food Items EEC (ppm) Predicted Maximum Residue EEC (ppm) Predicted Mean Residue Short grass 240 85 Tall grass 110 36 Forage and small insects 135 45 Fruits, pods, seeds, and large insects 15 7 These residues served as the initial concentrations from which first­ order residue declines were calculated. When considering repeat applications, degradation over time is simulated from the first application to a period following the last application. The time period modeled varies, depending on the number of applications, the interval between applications. However 30 days was usually modeled unless otherwise specified. The FATE5 program generates a peak value as well as a time­ weighted average value for the time period modeled. The Fletcher peak maximum value for the food item was compared to the acute toxicity value to produce the acute Risk Quotient (RQ). For chronic risk, the Fletcher maximum value was used as the initial input. Both the peak maximum for short grass and time­ weighted average maximum EECs for short grass and other food items were used to compute chronic RQs. For aquatic organisms, EPA estimates the concentration of parent disulfoton in surface water using the Tier II PRZM/ EXAMs models. 4. Nontarget Terrestrial Animal Risk a. Risk to Birds and Mammals EPA predicts acute risk to birds and mammals for both the granular (15 % ai) and liquid 8 EC (8 % ai) formulations. RQs for birds and mammals are summarized in Tables 10 thru 12 below. Bird kills have been associated with applications of granular disulfoton to a tree nursery and potatoes. Field studies in potatoes and small grains showed small mammals to be sensitive to the 15% granular product and jackrabbits to be sensitive to the liquid products. Also, EPA has received a poisoning report of Swainson hawks that died following ingestion of disulfoton contaminated grasshoppers. The Agency predicts chronic risk to birds and mammals from liquid disulfoton (8 EC); mammals appear to be at greater risk than birds. Table 10. Summary of Acute Ecological Risks to Birds and Mammals potentially exposed to Di­ Syston 8EC (liquid) in food. Use Scenario Risk Quotients (RQs) Crop Application Rate/ Method/ Site (foliar or soil) Number of Applications per Season Time Interval between Applications Birds 1 LC50 =333 ppm Mammals 2 Estimated 1 day LC50 = 2­ 12.7 ppm Tobacco 4 lbs ai/ A aerial (soil), unincorporated 1 N/ A 0.2­ 2.8 Adjacent to field 0.9­ 480 Adjacent to field 4 lbs ai/ A ground (soil), broadcast, incorporated 1 N/ A 0.2­ 1.6 Within field granivore & insectivore 0.9­ 270 Within field, granivore insectivore Potatoes NW only 3 lb ai/ A ground (foliar), chemigation 1 N\ A 0.1­ 2.2 0. 7­ 360 Potatoes 3 lb ai/ A ground (soil), unincorporated side dress 1 N/ A approx 0.1­ 2.2 Slightly less than foliar approx 0.7­ 360 Slightly less than foliar 3 lb ai/ A ground (soil), broadcast, incorporated 1 N/ A 0.1­ 1.2 Within field granivore & insectivore 0.7­ 202 Within field, granivore insectivore 3 lb ai/ A ground (soil), in furrow or injection 1 N/ A risk can not be quantified, but less than surface application risk can not be quantified, but less than surface application Peas & Lentils 2.5 lbs ai/ A ground (soil) injection or in furrow 1 N/ A risk can not be quantified, but less than surface application risk can not be quantified, but less than surface application Chili peppers 2 lbs ai/ A ground (soil), broadcast, incorporated 1 N/ A 0.1­ 0.8 Within field granivore & insectivore 0.5­ 135 Within field granivore & insectivore Use Scenario Risk Quotients (RQs) Crop Application Rate/ Method/ Site (foliar or soil) Number of Applications per Season Time Interval between Applications Birds 1 LC50 =333 ppm Mammals 2 Estimated 1 day LC50 = 2­ 12.7 ppm 9 Beans (snap, dry & lima), lettuce, cabbage 2 lbs ai/ A ground (soil), injection 1 N/ A risk can not be quantified, but less than surface application risk can not be quantified, but less than surface application Cotton, sorghum Broccoli, Wheat, cauliflower, brussels sprouts, cabbage, barley 1 lbs ai/ A ground (soil), injection 1 N/ A risk can not be quantified, but less than surface application risk can not be quantified, but less than surface application Wheat 0.75 lb ai/ A aerial (foliar) 1 0. 03­ 0.5 0.2­ 90 Poplars for pulp wood 3 lb ai/ A ground (soil), unincorporated 3 21 day interval 0.1­ 2.2 0. 7­ 364 Asparagus 1 lb ai/ A ground and or aerial (foliar) 3 assumed 21 day interval 0.05­ 0.7 0. 2­ 121 Barley 1 lb ai/ A ground and or aerial foliar 2 21 day interval 0.05­ 0.7 0. 2­ 121 Potato (East of Rockies only), brussels sprouts, cauliflower 0.5 lb ai/ A aerial or ground (foliar) 3 14 days 0.02­ 0.4 Ground less risk than aerial 0.13­ 63 Ground less risk than aerial Sorghum 0.5 lb ai/ A aerial (foliar) 2 14 days 0.02­ 0.4 0. 1­ 63 3 days 0.03­ 0.5 0. 2­ 92 Cotton (SLN) TX 0.2 lb ai/ A aerial (foliar) 2 21 days 0.01­ 0.15 0.05­ 24 1 RQs for birds vary according to food items consumed; the range is presented here. 2 RQs for mammals vary according to body weight and food items consumed; the range is presented here. Additional information can be found in the September 5, 2000, revised environmental risk assessment. 10 Table 11. Summary of Chronic Ecological Risks to Birds and Mammals potentially exposed to Di­ Syston 8EC (liquid) in food. Unless specified otherwise the RQ is based on a a 3.3 day half life and 30 day average maximum residue values. RQ in ( ) is based on peak maximum residues short grass. Use Scenario Risk Quotients (RQs) Crop Application Rate/ Method/ Site (foliar or soil) Number of Applications per Season Time Interval between Applications Birds 1 NOAEC = 37 ppm Mammals 2 NOAEC = 0.8 ppm Tobacco 4 lbs ai/ A aerial (soil), unincorporated 1 N/ A 0.3­ 4.5 (26) 13­ 210 (1200) 4 lbs ai/ A ground (soil), broadcast, incorporated 1 N/ A 0.3­ 2.5 (14) Within field granivore & insectivore 13­ 118 (675) Within field, granivore insectivore Potatoes NW only 3 lb ai/ A ground (foliar), chemigation 1 N\ A 0.2­ 3.4 (19) 9.8­ 158 (900) Potatoes 3 lb ai/ A ground (soil), unincorporated side dress 1 N/ A approx 0.2­ 3.4 (19) Slightly less than foliar approx 9.8­ 158 (900) Slightly less than foliar 3 lb ai/ A ground (soil), broadcast, incorporated 1 N/ A 0.2­ 1.9 (11) Within field granivore & insectivore 9.8­ 89 (506) Within field, granivore insectivore 3 lb ai/ A ground (soil), in furrow or injection 1 N/ A risk can not be quantified, but less than surface application risk can not be quantified, but less than surface application Peas & Lentils 2.5 lbs ai/ A ground (soil) injection or in furrow 1 N/ A risk can not be quantified, but less than surface application risk can not be quantified, but less than surface application Chili peppers 2 lbs ai/ A ground (soil), broadcast, incorporated 1 N/ A 0.1­ 1.3 (7.3) Within field granivore & insectivore 6.6­ 59 (337) Within field granivore & insectivore Beans (snap, dry & lima), lettuce, cabbage 2 lbs ai/ A ground (soil), injection 1 N/ A risk can not be quantified, but less than surface application risk can not be quantified, but less than surface application Use Scenario Risk Quotients (RQs) Crop Application Rate/ Method/ Site (foliar or soil) Number of Applications per Season Time Interval between Applications Birds 1 NOAEC = 37 ppm Mammals 2 NOAEC = 0.8 ppm 11 Cotton, sorghum Broccoli, Wheat, cauliflower, brussels sprouts, cabbage, barley 1 lb ai/ A ground (soil), injection 1 N/ A risk can not be quantified, but less than surface application risk can not be quantified, but less than surface application Wheat 0.75 lb ai/ A aerial (foliar) 1 N/ A 0.05­ 0.85 (4.9) 2.5­ 40 (225) Poplars for pulp wood 3 lb ai/ A ground (soil), unincorporated 3 21 day interval 0.3­ 4.9 (20) 63 day ave. 14­ 225 (911) 63 day ave Asparagus 1 lb ai/ A ground and or aerial (foliar) 3 assumed 21 day interval 0.1­ 1.6 (6.6) Ground less risk than aerial 63 day ave. 4.7­ 75 (304) Ground less risk than aerial 63 day ave. Barley 1 lb ai/ A ground and or aerial (foliar) 2 21 day interval 0.1­ 1.6 (6.6) Ground less risk than aerial 42 day ave 4.7­ 75 (304) Ground less risk than aerial 42 day ave Potato (East of Rockies only), brussels sprouts, cauliflower 0.5 lb ai/ A ground or aerial (foliar) 3 14 days 0.08­ 1.2 (3) Ground less risk than aerial 42 day ave 3.5­ 56 (158) Ground less risk than aerial 42 day ave Sorghum 0.5 lb ai/ A aerial (foliar) 2 14 days 0.07­ 1.1 (3) 3. 2­ 52 (158) 3 days 0.2­ 3 (5) 9 day ave 8.6­ 138 (230) 9 day ave Cotton (SLN) TX 0.2 lb ai/ A aerial (foliar) 2 21 days 0.02­ 0.3 (1) 42 day ave 0.9­ 15 (61) 42 day ave 1 RQs for birds vary according to food items consumed; the range is presented here. 2 RQs for mammals vary according to body weight and food items consumed; the range is presented here. Additional information can be found in the September 5, 2000, revised environmental risk assessment. The Agency's assessment suggests the potential for the 8 EC formulation (liquid) to cause acute effects to non endangered herbivorous birds from a single aerial application at or above 0.75 lb ai/ A. Endangered granivores would be at risk from a single, 2.0 lb ai/ A soil incorporated application. The avian acute RQs range from less than 0.1 for potatoes at 3.0 lbs ai/ ai when applied in furrow or soil injected to 2.8 on short grass from a single, 4 lb ai/ A aerial application 12 to tobacco. For the same use patterns/ food items, mammalian acute RQs range from less than 0.1 to 480. A comparison of the NOAECs from avian reproduction studies to estimated exposure concentrations from uses other than in furrow or soil injection, produced chronic RQs ranging from 0.02 for cotton (the 42­ day average on seeds for 2 aerial applications with 21 day intervals at 0.2 lbs ai/ A) to 26 for tobacco (the peak on short grass for a single aerial applications at 4.0 lbs ai/ A). For the same use patterns, when the NOAEL in the 2­ generation rat study is used as an endpoint, the chronic RQs range from 0.9 to 1200. For both birds and mammals, most of the RQs are above the Agency's level of concern for chronic effects. These exceedences last for several weeks. In all cases (except for in furrow or soil injection) for mammal, but only in a few uses for birds, not only the peak residues, but also the time weighted average residues exceed the test levels at which chronic effects were observed (LOAECs). Registrants have expressed concern regarding the Agency's use of Fletcher values and models such as FATE5 in its preliminary exposure assessment. Two field residue monitoring studies submitted by a registrant were pertinent to current uses of disulfoton on potatoes. In the study (MRID #412018­ 01), Di­ Syston 8 was aerially applied to potato foliage 3 times (6 to 10 day intervals) at 1 lb ai/ acre in Michigan. Residues on the potato leaves peaked at 105 ppm after the 2 nd application and had a mean value of 41 ppm over the course of the study. These values are reasonably close to the FATE5 model (scenario was 1 lb ai/ A, 3 applications, 10 day interval, 21 day sampling period, and half life 3.3 days) estimate of residues on broadleaves of 153 ppm (peak) and 51ppm (mean). A second residue monitoring study (MRID #411189­ 01) in Michigan was performed, in which Di­ Syston 8 was soil incorporated by ground equipment, (initially in furrow at planting at 3 lb ai/ acre and 6 ­ 7 weeks later as a side dressing at 3 lbs ai/ acre). As was expected the residues on potato foliage were lower (peak was 44 ppm and mean was 8 ppm) than in the first study. Finding residues is due in part because disulfoton is systemic and secondly, though directed at the soil, some spray would contact the emerged plants during the second application. In conclusion, the foliar application study appears to support the use of the Fletcher values in a model such as FATE5 to predict residues on foliage. The acute and chronic RQs are based solely on dietary exposure via contaminated food sources. Other routes of exposure, including dermal, inhalation, and drinking from contaminated puddles might also be important (Driver et al. 1991) and could further increase acute risks if methods were available to include them in the risk assessment. Other factors contributing to uncertainty (especially for chronic effects) include when exposure occurs during the reproductive cycle; the duration of exposure required to cause a physiological effect and sub lethal effects to adults that may impact breeding and nurturing behavior. The following table summarizes the acute risk to birds and mammals from the use of the granular formulation (15 G) of disulfoton. 13 Table 12. Acute Risk Estimates for Birds and Mammals Exposed to Di­ Syston 15G (Granular). Based on mallard ago LD50 (6.54mg/ kg) and rat a. o. LD50 (1.9 mg/ kg). Use Scenario RQs Crop Application Rate lb ai/ A and or (oz. ai/ 1000 ft) Application Method mg ai/ ft 2 exposed on soil surface Birds Mammals Christmas trees (approx 1700/ A) 78 (0.69 oz ai/ tree ~ 2 ft 2 ) Spot treatment/ broadcast, unincorporated approx 9,780 approx 1,500­ 75,200 approx 5,100­ 257,300 Christmas trees (SLN) NC approx 1700/ A 4.5 (0.04 oz ai / tree ~ 2 ft 2 ) Spot treatment/ broadcast, unincorporated 567 approx 85­ 4,350 approx 300­ 14900 Tobacco 4 (6) Banded (assume 6 inches), incorporated 51 7­ 392 26­ 1342 Banded (assume 12 inches), incorporated 25.5 3. 5­ 196 13­ 671 Broadcast, incorporated 6.2 0. 9­ 48 3­ 164 Ornamental flowers (gladiolus) 28.6 (1.05 oz/ 100 ft 2 ) broadcast, incorporated 45 6.8­ 346 24­ 1184 Ornamental flowers (gladiolus) 4.5( 0.16 oz/ 100 ft 2 ) broadcast, incorporated 7 1­ 54 3. 6­ 184 Ornamental flowers (gladiolus) 6 (11.25) banded– in trench, incorporated assumed zero assumed zero assumed zero Potatoes 3 (3.4) Banded (assume 6 inches) incorporated 28.9 4. 5­ 225 15­ 772 Broadcast, incorporated 4.7 0. 7­ 35 2. 5­ 123 In furrow, incorporated 1.9 0. 3­ 15 1­ 51 Peas and Lentils 2.5 Broadcast, unincorporated 26 3.8­ 198 13­ 683 Peppers 2 (2) Banded (assume 6 inches), incorporated 17 2.5­ 130 9­ 447 Soy beans 1 (1.2) Banded ( 4 inch), incorporated 17 2.5­ 130 9­ 447 Cabbage 1.5 (1.7) Banded (assume 6 inches), incorporated 14.4 2. 2­ 110 7.5­ 378 Sorghum 1 1 Broadcast to whorls 10.4 1.5­ 80 5­ 270 Use Scenario RQs Crop Application Rate lb ai/ A and or (oz. ai/ 1000 ft) Application Method mg ai/ ft 2 exposed on soil surface Birds Mammals 14 Barley, wheat 1 Broadcast, unincorporated 10.4 1. 5­ 80 5­ 270 Drilled approx 0.1 approx <0.1­ 0.8 approx <0.1­ 2.7 Clover 1 (for seed) SLN 1 Broadcast to foliage, unincorporated 10.4 1. 5­ 80 5­ 270 Cotton, sorghum 1 (1.2) Banded (assume 6 inches), incorporated 10.2 1. 5­ 80 5­ 270 Peanuts, cole crops, 1 (1.1) Banded (assume 6 inches), incorporated 9.3 1. 4 ­70 5­ 240 Beans (Lima, Dry) 1 (0.9) Banded (6inch), incorporated 7.6 1. 1­ 70 4­ 200 Ornamental trees (Holly, birch) 4.5 Broadcast, incorporated 7.0 1­ 54 3. 6­ 184 Ornamental trees (Holly, birch) (12 oz) In furrow 6. 8 1­ 52 3.5­ 178 Cotton, sorghum 1 (1.2) In furrow, incorporated 0.68 0.1­ 5 0. 3­ 17 Peanuts 1 (1.1) In furrow, incorporated 0.62 0.1­ 5 0. 3­ 17 1Some granules will be retained in/ on foliage and could be ingested by non target birds and mammals. RQs for birds and mammals vary according to body weight; the range is presented here. Additional information can be found in the September 5, 2000, revised environmental risk assessment. The Agency's assessment suggests potential for the 15 G formulation to cause acute risk to birds from a single application at or above the lowest application rate of 1.0 lb ai/ A even when the material is incorporated. The avian acute RQs for small birds range from 5 for the in furrow, 1 lb ai/ A rate on cotton to approximately 75,200 for 78 lb ai/ A, unincorporated spot treatment to Christmas trees. For the same use patterns/ food items, small mammal acute RQs range from 17 to 257,300. EPA can not estimate long term exposure from granular applications because the granules are not expected to remain in tact over extended periods. The chemical is expected to become distributed in the soil, as the granules dissipate. However even a brief exposure period may be sufficient to cause chronic risk because disulfoton is chronically toxic to birds and mammals at low dietary concentrations. Risk to birds and mammals from the use of 15 G (SLN) on Christmas tree farms in North 15 Carolina Christmas tree farms and the adjacent areas ­­ forests and or pasture – provide excellent habitat for a great variety of wild life. The North Carolina Christmas Tree community has submitted numerous testimonials emphasizing the ever increasing numbers and diversity of wild life . This includes game animals such as turkey rearing young amidst the trees, song birds, rodents and foxes. Although this information is intended to suggest there is little or no negative impact from not only disulfoton, but other pesticides or cultural practices as well, the Agency would prefer to receive documented surveys or research before making a final determination. b. Non target Insects Disulfoton is moderately toxic to honey bees and its sulfoxide and sulfone degradates are highly toxic to bees. Although a 24 hour residual study on the 8 EC indicated no toxicity to honey bees following exposure to alfalfa that had been treated 3 hours earlier at a rate of 1.0 lb/ A., there is uncertainty as to the risk from later exposure and a longer period of time to the more toxic degradates. Furthermore, the risk from higher rates – especially aerial and foliar applications – can not be assessed without additional data. 5 Risk to Nontarget Aquatic Animals Disulfoton technical is moderately to very highly toxic to freshwater fish; very highly toxic to freshwater invertebrates; highly toxic to estuarine fish and highly to very highly toxic to estuarine invertebrates. None of these organisms were at risk from disulfoton when the EC was soil injected. Neither fresh water nor estuarine fish acute risk Levels Of Concern (LOC) are exceeded; however, a few uses exceed restricted use and endangered species concerns for fresh water fish. Chronic risk to freshwater and estuarine fish may occur from uses where single application rates are equal to 4 lb a. i./ A. Estuarine fish may also be at chronic risk from 2 or more applications of the EC formulation at rates equal to or greater than 1 lb ai/ A. Although many modeled crop scenarios suggest a potential for acute risk for freshwater invertebrates; except for the greater risk from the tobacco use, RQs were between 0.5 and 2.1 with most being less than one. Typically, unless soil injection was employed, the invertebrate restricted use and endangered species concerns were exceeded. Chronic risk to fresh water invertebrates (i. e., number of young produced, their survival and growth) is predicted for all modeled scenarios. Although modeling predicts acute and chronic risks estuarine/ marine invertebrates for a few uses on such sites as tobacco, barley and cotton, there is uncertainty in the exposure estimates and the RQs are less then 2 for acute and less then 6 for chronic risk. RQs for fish and invertebrates are summarized in Tables 13 and 14. (i) Freshwater Fish – Acute and Chronic Risk Acute risk LOC is not exceeded for any use patterns. RQs range from <0.01 (soil injection of the EC to any crop or one unincorporated application of the 15 G by ground 16 equipment to soil at 1.0 lb ai/ A to wheat) to 0.48 (1 aerial application of 4.0 lb ai/ A to soil for tobacco). The restricted use LOC is exceeded by a single application at rates greater than or equal to1.0 lb ai/ A.. The endangered species LOC is exceeded by: 1) a single, unincorporated application at rates greater than or equal to 0.75 lb ai/ A and 2) 2 or more unincorporated applications at 0.2 lbs ai/ A. Chronic risk is only exceeded by one application regime in tobacco the RQ is 1.5 for a single aerial application to soil (followed by incorporation) at 4.0 lb ai/ A. While the acute LC50 was never exceeded by peak concentrations mortality is predicted for some application regimes of the EC for tobacco, barley and possibly asparagus (other than N. West). In a series of miniature ponds known as microcosms, bluegills were exposed to a range of concentrations for 27 days. This resulted in a 27 day LC10 of 4.7 parts per billion. Since LC10 is exceeded by the modeled 21­ day average EEC's (4.5 to 12 ppb) for these 3 uses, this suggests use of disulfoton adjacent to aquatic sites may result in mortality to freshwater fish. Three fish kills associated with tobacco and wheat were reported to the Agency in which disulfoton and or two metabolites – the sulfoxide and sulfone were present. These metabolites are persistent and 1/ 3 to 1/ 5 less toxic than disulfoton; they may have contributed to the impact. However, it should be noted that other toxic chemicals were also discovered in the water in two of the incidents and in the other instance runoff contributed decaying vegetation and sediment that may have resulted in very low oxygen levels. (ii) Freshwater Invertebrates a Acute Risk The fresh water invertebrate acute risk RQs range from <0.01 (soil injection of the EC to any crop or one unincorporated application of the 15 G by ground equipment to soil at 1.0 lb ai/ A to wheat) to 4.8 (1 aerial application, followed by incorporation, of 4.0 lb ai/ A to soil for tobacco). Acute risk is usually exceeded by: 1) one incorporated or unincorporated application of the EC at rates equal to or greater than 1.0 lb ai/ A; 2) one unincorporated application of the 15 G at rates equal to or greater than 1.0 lb ai/ A; 3) 2 or more aerial unincorporated applications of the EC at rates equal to or greater than 0.2 lbs ai/ A. 4) 2 or more unincorporated ground applications of the EC at rates equal to or greater than 0.5 lbs ai/ A. The restricted use LOC is exceeded by nearly all techniques for all modeled sites. The exceptions are soil injection applications of the EC; one unincorporated application of the 15 G by ground equipment to soil at 1.0 lb ai/ A to wheat and one soil incorporated, ground application of the 15 G at 2.0 lbs ai/ A for chili peppers. All techniques for all modeled sites exceed the endangered species LOC except for soil injection of the EC and one unincorporated application of the 15 G by ground equipment to soil at 1.0 lb ai/ A to wheat. b Chronic Risk Chronic risk is anticipated from all regimes for all modeled sites except for soil injection and one unincorporated application of the 15 G by ground equipment to soil at 1.0 lb ai/ A to 17 wheat. RQs for all of the modeled crop scenarios greatly exceeded the LOC of one. The 21­ day average EECs for the modeled sites that exceeded chronic risk concerns ranged from 0.2 ppb (chili peppers– single application of soil incorporated 15 G at 2 lbs ai/ A) to 12 ppb (tobacco– a single aerial application, followed by soil incorporation of the EC at 4 lbs ai/ A). Invertebrate life­ cycle testing on daphnia with disulfoton showed impacts to reproductive parameters (number of young produced by adults) as well as impacts to survival and growth occurring between 0.037 and 0.07 ppb. With the exception of soil injection of the EC formulation (where residues in water were considered to be zero) the RQs ranged from 5 to 324. Because invertebrates have a short life cycle, their reproduction is more likely to be at least temporarily impacted by a brief exposure of adults to disulfoton concentrations near the NOAEC. A microcosm study toxic suggests that disulfoton's impacts to the invertebrate community may be short term and only slightly extended due to the toxicity and persistence of the degradates of disulfoton. Similarly to their toxicity to freshwater fish the two primary degradates – D. sulfone and D. sulfoxide – are respectively approximately 1/ 3 to 1/ 5 as acutely toxic as parent disulfoton.. The chronic toxicity to daphnia magna of these two degradates is approximately 1/ 3 (for D. sulfone) and 1/ 45 (for D. sulfoxide). The invertebrates were dosed four times during the first 28 days of the 77 day study. An analysis of the data suggests short term negative impact from exposure as low as 3 ppb, but recovery occurred by the end of the study for most invertebrate populations exposed to 30 ppb. It should be noted that at this time the Agency has not validated the significance of microcosm studies. (iii) Estuarine and Marine Fish – Acute and Chronic Risk There is uncertainty in using the PRZM/ EXAMS EECs derived for ponds to predict exposure to marine/ estuarine organisms. The scenarios modeled are based on hydrologic data for ponds. Estuarine fish residing in the upper reaches of tributaries of bays would be exposed to residues coming from adjacent crop lands. Exposure to pesticide residues in estuarine habitats may be higher or lower than that predicted for pond, depending upon the volume of water and residence time in the estuary. An additional uncertainty is the fact that the only species tested Sheepshead minnow­­ probably does not represent the true range of sensitivity of marine or estuarine fish; therefore both the acute and chronic risk may be underestimated. Nevertheless, acute risk to estuarine and marine fish appears to be low, because the RQs for all modeled crops are less than 0.05 –the LOC for endangered species. Concerning chronic risk, in addition to the previously stated uncertainties, other uncertainties are the duration adult fish must be exposed to disulfoton for their reproductive systems to be effected and when in their reproductive cycle is the impact occurring. For example, even if adults are effected after an exposure of only a week, disulfoton residues may dissipate from an area within several days resulting in little or no chronic risk. However, based on modeling and the results (endpoints of concern included fecundity, hatching success, and growth) of the fish full life­ cycle test only some of the uses on 3 crops – tobacco, cotton and barley – slightly exceed the chronic risk levels of concern. The RQs showing exceedences range 18 from 2 for barley ( 2 lb ai/ A, 2 applications at 21 day intervals) to 5 for tobacco (a single application of the liquid formulation at 4 lb ai/ A). All other modeled uses had RQs less than the level of concern of 1. (iv) Estuarine and Marine Invertebrates – Acute and Chronic Risk Similar to the risk assessment for estuarine fish the same uncertainties associated with exposure apply to estuarine invertebrates. Most of the modeled scenarios do not exceed the acute or restricted use criteria for marine and estuarine invertebrates. The RQs range from <0.01 (a single soil injected application of 1­ 2.5 lbs ai/ A for a variety of vegetables) to 1.26 ( one aerial application of the liquid formulation at 4 lbs ai/ A to tobacco). Although nearly all uses exceeded endangered species risk concerns, currently there are no marine or estuarine invertebrates listed as endangered. Few of the modeled crop scenarios show the potential for chronic risk to marine and estuarine invertebrates; those that do (ie some uses in tobacco, cotton and barley) have RQs between 1 and 5. Mysid shrimp are less sensitive than daphnia, the surrogate for freshwater invertebrates; therefore, on the basis of this limited data, the chronic impact to estuarine invertebrates appears to be lower than freshwater invertebrates. The following 3 tables – 13 thru 15 – contain the Estimated Environmental Concentrations (EECs) and Risk Quotients (RQs) for the risk assessment for freshwater and estuarine organisms. 19 Table 13. Tier II Upper Tenth Percentile EECs for Disulfoton Parent Used on barley, cotton, potatoes, tobacco, and wheat for current and proposed applications estimated using PRZM3/ EXAMS Crop Disulfoton Application Concentration ( : g/ L) (1­ in­ 10 annual yearly maximum value) Mean of Annual Means ( : g/ L) Rate/ Number of Apps/ Interval/ Incorp. Depth / method 1 lb. ai/ A/ #/ days/ inches Peak 96­ Hour Avg. 21­ Day Avg. 60­ Day Avg. 90­ Day Avg. Annual Avg. Tobacco 4.0/ 1/ 0/ 2.5/ a, s 18.97 17.26 11.86 7.12 4.91 1.24 0.83 Tobacco 4.0/ 1/ 0/ 2.5/ g, s 12.02 10.93 8.08 4.39 3.04 0.76 0.35 Tobacco 4.0/ 1/ 0/ 2.5/ g, s (granular) 2. 09 1. 90 1. 41 0. 75 0. 52 0. 13 0. 05 Barley 1.0 /2/ 21/ 0/ a, f 8. 28 7. 44 5. 52 3. 58 2. 91 0. 75 0. 49 Barley 1.0 /2/ 21/ 0/ g, f 6. 61 5. 94 4. 47 2. 65 2. 04 0. 52 0. 25 Barley 1.0/ 2/ 21/ 0/ g, s (granular) 6. 41 5. 75 4. 35 2. 56 1. 90 0. 47 0. 19 Cotton 1. 0 /1/ 0/ 2.5/ g, s 4.28 3.89 2.83 1.46 1.00 0.25 0.10 Cotton SLN (TX) 0.2/ 2/ 21/ 0 /a, f 2.71 2.36 1.55 0.92 0.66 0.18 0.13 Cotton 1. 0/ 1/ 0/ 2.50/ g, s (granular) 0. 79 0. 72 0. 52 0. 27 0. 19 0. 05 0. 02 Cotton, wheat 1/ 1/ 0/ 2.5/ g, s (injection) 0.00 0.00 0.00 0.00 0.00 0.00 0.00 Potatoes 0.5 /3/ 14/ 0/ a, f 2. 91 2. 59 2. 07 1. 33 0. 94 0. 23 0. 20 Potatoes 3.0/ 1/ 0/ 0/ g, s 2. 53 2. 26 1. 74 0. 92 0. 63 0. 17 0. 11 Potatoes 3.0/ 1/ 0/ 2.5/ g, s 1. 81 1. 63 1. 27 0. 64 0. 44 0. 11 0. 09 Potatoes 0.5 /3/ 14/ 0/ g, f 1. 32 1. 18 0. 87 0. 50 0. 36 0. 09 0. 06 Potatoes 3.0/ 1/ 0/ 2.5/ g, s (granular) 0. 53 0. 47 0. 35 0. 18 0. 12 0. 03 0. 11 Sorghum 0.5/ 2/ 14/ 0a, f 2.98 2.59 1.74 1.04 0.71 0.20 0.13 Crop Disulfoton Application Concentration ( : g/ L) (1­ in­ 10 annual yearly maximum value) Mean of Annual Means ( : g/ L) Rate/ Number of Apps/ Interval/ Incorp. Depth / method 1 lb. ai/ A/ #/ days/ inches Peak 96­ Hour Avg. 21­ Day Avg. 60­ Day Avg. 90­ Day Avg. Annual Avg. 20 Sorghum 0.5/ 2/ 3/ 0a, f 2.90 2.52 1.76 0.94 0.64 0.18 0.13 Sorghum 0.5/ 2/ 14/ 0g, f 2. 00 1. 74 1. 03 0. 55 0. 38 0. 11 0. 04 Sorghum 1/ 1/ 0/ 4 g, s (granular) 0. 86 0. 78 0. 51 0. 23 0. 16 0. 05 0. 02 Winter wheat 0.75/ 1// 0/ 0 a, f 2. 19 1. 98 1. 54 0. 77 0. 53 0. 14 0. 11 Winter wheat 0.75/ 1// 0/ 0 g, f 0. 95 0. 85 0. 60 0. 30 0. 21 0. 05 0. 03 Winter wheat 1/ 1/ 0/ 0 g, s (granular) 0. 00 0. 00 0. 00 0. 00 0. 00 0. 00 0. 00 Spring Wheat 0.75/ 1// 0/ 0 a, f 2. 10 1. 96 1. 54 0. 86 0. 59 0. 16 0. 13 Values are Tier II Estimated Environmental Concentrations (EECs) for Disulfoton Parent using PRZM/ EXAMS based on Current and Proposed Rates for Disulfoton All EECs are the 1­ in­ 10 annual yearly maximum values. 1 Method of application: g = ground, a = aerial f = foliar and s = soil; unless specified the emulsifiable concentrate (EC) was modeled. 21 Table 14. Acute Risks to Freshwater and Estuarine Organisms Potentially Exposed to Disulfoton in Surface Water Use Scenario Risk Quotients (RQs = EEC/ Tox value) for Aquatic Organisms Crop and Formulation (liquid unless specified) Application Rate (lbs ai/ A)/ Method/ Site (foliar or soil) Number of Applications per Season Time Interval between Applications (days) Peak (ppb ai) Freshwater Estuarine Fish (Bluegill) LC50 39 ppb Invertebrates (glass shrimp) LC50 3.9 ppb Fish (Sheepshead Minnow) LC50 520 ppb Invertebrates (Brown Shrimp) LC50 15 ppb Tobacco 4, aerial (soil) incorporated 1 N/ A 19 0.48 4.8 0. 04 1. 26 4, ground (soil) incorporated 1 N/ A 12 0.30 3 0. 02 0. 80 Tobacco (Granular) 4, ground (soil) incorporated 1 N/ A 2 0. 05 0. 5 <0.01 0. 13 Barley Asparagus 1 1, aerial (foliar) 2 21 8. 3 0.21 2.1 0. 02 0. 55 1, ground (foliar) 2 21 6. 6 0.17 1.7 0. 01 0. 44 Barley (Granular) 1, ground (soil) unincorporated 2 21 6. 4 0.16 1.6 0. 01 0. 43 Cotton 1, ground (soil) incorporated 1 N/ A 4.3 0. 11 1. 1 <0.01 0. 28 Cotton (SLN) TX 0.2, aerial (foliar) 2 21 2. 7 0.07 0.7 <0.01 0.18 Cotton (granular) 1, ground (soil) incorporation 1 N/ A 0.8 2 0.02 0.2 <0.01 0.05 Sorghum 0.5, aerial (foliar) 2 3 approx 3 0. 08 0. 77 <0.01 0.20 14 Sorghum 0.5, ground (foliar) 2 14 2 0.05 0.5 <0.01 0.13 Use Scenario Risk Quotients (RQs = EEC/ Tox value) for Aquatic Organisms Crop and Formulation (liquid unless specified) Application Rate (lbs ai/ A)/ Method/ Site (foliar or soil) Number of Applications per Season Time Interval between Applications (days) Peak (ppb ai) Freshwater Estuarine Fish (Bluegill) LC50 39 ppb Invertebrates (glass shrimp) LC50 3.9 ppb Fish (Sheepshead Minnow) LC50 520 ppb Invertebrates (Brown Shrimp) LC50 15 ppb 22 Sorghum 1, ground (soil) incorporated 1 N/ A between 0.9 and 2 0.04 3 0.4 3 <0.01 3 0.10 3 Sorghum (granular) 1, ground (soil) incorporated 1 N/ A 0.9 0. 02 0. 2 <0.01 0. 06 Cotton, peanuts, sorghum (granular) 1, ground (soil) in furrow 1 N/ A< 0. 8 3 <0.02 <0.2 <0.01 <0.05 Cotton 1, ground (soil) injection 1 1 approx zero <0.01 <0.01 <0.01 <0.01 Potatoes 0.5, aerial (foliar) 3 14 2. 9 0.07 0.7 <0.01 0.19 3, ground (soil) unincorporated 1 N/ A 2.5 0. 06 0. 6 <0.01 0. 17 3, ground (soil) in furrow 1 N/ A 1.8 0. 05 0. 5 <0.01 0. 12 0.5, ground (foliar) 3 14 1. 3 0.33 0.3 <0.01 0.09 Potatoes (N. West only) 4 3, ground (foliar) chemigation 1 N/ A between 1.8 and 2.5 0.05 5 0.5 5 <0.01 5 N/ A 0.14 5 N/ A Potatoes (granular) 3, ground (soil) incorporated 1 N/ A 0.5 0. 01 0. 1 <0.01 0. 03 Peas, lentiles 6 2.5, ground (soil) in furrow 1 N/ A 2.5 0. 06 0. 6 <0.01 0. 17 Wheat (Fall) 0.75, aerial (foliar) 1 N/ A 2.1 0. 05 0. 5 <0.01 0. 14 Use Scenario Risk Quotients (RQs = EEC/ Tox value) for Aquatic Organisms Crop and Formulation (liquid unless specified) Application Rate (lbs ai/ A)/ Method/ Site (foliar or soil) Number of Applications per Season Time Interval between Applications (days) Peak (ppb ai) Freshwater Estuarine Fish (Bluegill) LC50 39 ppb Invertebrates (glass shrimp) LC50 3.9 ppb Fish (Sheepshead Minnow) LC50 520 ppb Invertebrates (Brown Shrimp) LC50 15 ppb 23 Wheat (Spring) 0.75, aerial (foliar) 1 N/ A 2.2 0. 06 0. 6 <0.01 0. 15 0.75, ground (foliar) 1 N/ A 0.9 0. 02 0. 2 <0.01 0. 06 Wheat (granular) 1, ground (soil) unincorporated 1 N/ A <0.01 <0.01 <0.01 <0.01 <0.01 Chili peppers 7 2, ground (soil) incorporated. 1 N/ A 1.2 0. 03 0. 3 <0.01 0. 08 Chili peppers 8 (granular) 2, ground (soil) incorporated. 1 N/ A 0.3 <0.01 0.07 <0.01 0. 02 Peas, lentils Beans (snap, dry & lima), lettuce, broccoli, cauliflower, brussels sprouts, cabbage, wheat, barley 9 1 to 2.5, ground (soil) injection 1 N/ A approx zero <0.01 <0.01 <0.01 <0.01 1 The RQs for asparagus in the N West are assumed to be much less than for foliar applications to barley even though there is potential for three applications.. There is little or no rainfall causing runoff during the application period. (Personnel communication with Alan Schriber Wash State Dept of Ag). However, EECs may be higher where rainfall is expected. 2 In furrow locates most of the applied material lower in the soil profile than incorporation by tillage; therefore exposure from run off will be less. 3 RQ derived from the average of the range of EECs (1.45) divided by the toxicity value. 4 Other potato scenarios were for Maine where run off and rainfall is greater than N West. Although drift may be greater than conventional ground spray (1 %) the proximity to adjacent water bodies is farther in the N West. Finally, the amount available for runoff is less when material is applied to foliage rather than soil. 5 RQ derived from the average of the range of EECs (2.15) divided by the toxicity value. 6 EEC is estimated to be proportional to the EEC for potato (3 lb ai/ A ground application of liquid when in furrow) 24 7 EEC estimated to be proportional to the EEC for potato (3 lb ai/ A ground application of liquid, soil incorporation) 8 EEC estimated to be proportional to the EEC for potato (3 lb ai/ A ground application granular, soil incorporation) 9 EEC is estimated to be the same as for cotton (1 lb ai/ A ground application of liquid when injected = approx. zero) Based on the data described above, disulfoton poses the greatest acute risk to freshwater invertebrates and the least risk to estuarine fish. Table 15. Chronic Risks to Freshwater and Estuarine Organisms Potentially Exposed to Disulfoton in Surface Water Use Scenario Risk Quotients (RQs =EEC/ NOAEC) 1 for Aquatic Organisms Crop and Formulation (liquid unless specified) Application Rate (lbs ai/ A)/ Method/ Site (foliar or soil) Number of Applications per Season Time Interval between Applications (days) Day Ave (ppb ai) Freshwater Estuarine 21 60 90 Fish (Bluegill) 2 4.6 ppb Invertebrates (Daphnia) 0.037 ppb Fish (Sheepshead Minnow) 3 0.96 ­ 16.2 ppb Invertebrates (Mysid Shrimp) 2.35 ppb Tobacco 4, aerial (soil) incorporated 1 N/ A 12 7 5 1. 5 324 0.4 ­ 5 5 4, ground (soil) incorporated 1 N/ A8 4 3 0. 92160. 2 ­ 33 Tobacco (Granular) 4, ground (soil) incorporated 1 N/ A 1.4 0. 7 0.5 0. 1 38 <0.1 ­ 0.5 0. 6 Barley, asparagus 4 1, aerial (foliar) 2 21 5. 5 3.6 2. 9 0.8 149 0.2 ­ 3 2. 3 1, ground (foliar) 2 21 4. 5 2.6 2 0.6 122 0.2 ­ 2 1. 9 Barley (Granular) 1, ground (soil) unincorporated 2 21 4. 3 2.5 1. 9 0.5 116 0.1 ­2 1.8 Use Scenario Risk Quotients (RQs =EEC/ NOAEC) 1 for Aquatic Organisms Crop and Formulation (liquid unless specified) Application Rate (lbs ai/ A)/ Method/ Site (foliar or soil) Number of Applications per Season Time Interval between Applications (days) Day Ave (ppb ai) Freshwater Estuarine 21 60 90 Fish (Bluegill) 2 4.6 ppb Invertebrates (Daphnia) 0.037 ppb Fish (Sheepshead Minnow) 3 0.96 ­ 16.2 ppb Invertebrates (Mysid Shrimp) 2.35 ppb 25 Cotton 1, ground (soil) incorporated 1 N/ A 2.8 1. 5 1 0. 3 76 <0.1 ­ 1 1. 2 Cotton (SLN) TX 0.2, aerial (foliar) 2 21 1. 5 0.9 0. 7 0.2 40 <0.1 ­ 0.7 0. 6 Cotton (granular) 1, ground (soil) incorporation 1 N/ A 0.5 5 0.3 5 0.2 5 <0.1 13 <0.1 ­ 0.2 0. 2 Sorghum 0.5, aerial (foliar) 2 3 approx 1.7 approx 1.0 approx 0.7 0.2 46 <0.1 ­ 0.7 0. 7 14 Sorghum 0.5, ground (foliar) 2 14 1. 0 0.5 0. 4 0.1 27 <0.1 ­ 0.4 0. 4 Sorghum 1, ground (soil) incorporated 1 N/ A between 0.5 and 1.0 between 0.2 and 0.5 between 0.1 and 0.4 <0.1 6 19 6 <0.1 ­ 0.2 6 0.3 6 Sorghum (granular) 1, ground (soil) incorporated 1 N/ A 0.5 0. 2 0.1 <0.1 13 <0.1 ­ 0.1 0. 2 Cotton, peanuts, sorghum (granular) 1, ground (soil) in furrow 1 N/ A< 0. 5 6 <0.3 6 <0.2 6 <0.1 <13 <0.1 ­< 0.2 <0.2 Cotton 1, ground (soil) injection 1 N/ A approx zero approx zero approx zero <0.01 <0.01 <0.01 <0.01 Potatoes 0.5, aerial (foliar) 3 14 2 1.3 0. 9 0.3 54 <0.1 ­ 0.9 0. 8 3, ground (soil) unincorporated 1 N/ A 1.7 0. 9 0.6 0. 2 50 <0.1 ­ 0.6 0. 7 Use Scenario Risk Quotients (RQs =EEC/ NOAEC) 1 for Aquatic Organisms Crop and Formulation (liquid unless specified) Application Rate (lbs ai/ A)/ Method/ Site (foliar or soil) Number of Applications per Season Time Interval between Applications (days) Day Ave (ppb ai) Freshwater Estuarine 21 60 90 Fish (Bluegill) 2 4.6 ppb Invertebrates (Daphnia) 0.037 ppb Fish (Sheepshead Minnow) 3 0.96 ­ 16.2 ppb Invertebrates (Mysid Shrimp) 2.35 ppb 26 3, ground (soil) in furrow 1 N/ A 1.3 0. 6 0.4 0. 1 35 <0.1 ­ 0.4 0. 5 0.5, ground (foliar) 3 14 0. 9 0.5 0. 4 0.1 24 <0.1 ­ 0.4 0. 4 Potatoes (N. West only) 7 3, ground (foliar) chemigation 1 N/ A between 1.3 and 1.7 between 0.6 and 0.9 between 0.4 and 0.6 0.1 8 40 8 <0.1 ­ 0.5 8 N/ A 0.6 8 N/ A Potatoes (granular) 3, ground (soil) incorporated 1 N/ A 0.3 0. 2 0.1 <0.1 8 <0.1 ­ 0.1 0. 1 Peas, lentiles 9 2.5, ground (soil) in furrow 1 N/ A 1.1 0. 5 0.3 0. 1 30 <0.1 ­ 0.3 0. 5 Wheat (Fall) 0.75, aerial (foliar) 1 N/ A 1.5 0. 9 0.6 0. 2 40 <0.1 ­ 0.6 0. 6 Wheat (Spring) 0.75, aerial (foliar) 1 N/ A 1.5 0. 8 0.5 0. 2 40 <0.1 ­ 0.5 0. 6 0.75, ground (foliar) 1 N/ A 0.6 0. 3 0.2 <0.1 16 <0.1 ­ 0.2 0. 3 Wheat (granular) 1, ground (soil) unincorporated 1 N/ A 0.002 0.001 0.001 <0.01 <0.1 <0.01 <0.01 Chili peppers 10 2, ground (soil), incorp. 1 N/ A 0.8 0. 4 0.3 <. 1 21 <0.1 ­ 0.3 0. 3 Chili peppers 11 granular 2, ground (soil), incorp. 1 N/ A 0.2 0. 1 0.07 <0.1 5 <0.1 <0.1 Use Scenario Risk Quotients (RQs =EEC/ NOAEC) 1 for Aquatic Organisms Crop and Formulation (liquid unless specified) Application Rate (lbs ai/ A)/ Method/ Site (foliar or soil) Number of Applications per Season Time Interval between Applications (days) Day Ave (ppb ai) Freshwater Estuarine 21 60 90 Fish (Bluegill) 2 4.6 ppb Invertebrates (Daphnia) 0.037 ppb Fish (Sheepshead Minnow) 3 0.96 ­ 16.2 ppb Invertebrates (Mysid Shrimp) 2.35 ppb 27 Peas, lentils beans (snap, dry & lima), lettuce, broccoli, cauliflower, brussels sprouts, cabbage, wheat, 12 1 to 2.5, ground (soil), injection 1 N/ A approx zero approx zero approx zero <0.01 <0.01 <0.01 <0.01 1Risk quotients for fresh water / estuarine invertebrates and freshwater fish are based on 21 and 60 day EECs, respectively. 2 Bluegill NOAEC (4.6 ppb) is derived from the less sensitive rainbow trout chronic: acute ratio of 0.119. 3 Risk quotients for estuarine fish are based on 60 and 90 day EECs. Lower value derived is from 60 EEC and fish early life stage (fertilized egg through swim­ up stage of larvae). Higher value is from 90 day EEC and full life cycle (fertilized egg through survival of juveniles of next generation). 4 The RQs for asparagus in the N West are assumed to be less than for foliar applications to barley even though there is potential for three applications. There is little or no rainfall causing runoff during the application period. (Personnel communication with Alan Schriber Wash State Dept of Ag). However, EECs may be higher where rainfall is expected. 5 In furrow locates most of the applied material lower in the soil profile than incorporation by tillage; therefore exposure from run off will be less. 6 RQ derived from the average of the range of EECs divided by the toxicity value. The averages are as follows: 21 day ave.= 0.7, 60 day ave.= 0.3, 90 day ave= 0.2. 7 Other potato scenarios were for Maine where run off and rainfall is greater than N West. Although drift may be greater than conventional ground spray (1 %) the proximity to adjacent water bodies is farther in the N West. Finally, the amount available for runoff is less when material is applied to foliage rather than soil. 8 RQ derived from the average of the range of EECs divided by the toxicity value. The averages are as follows: 21 day ave.= 1.5, 60 day ave.= 0.7, 90 day ave= 0.5. 9 EEC is estimated to be proportional to the EEC for potato (3 lb ai/ A ground application of liquid when in furrow) 10 EEC estimated to be proportional to the EEC for potato (3 lb ai/ A ground application of liquid, soil incorporation) 11 EEC estimated to be proportional to the EEC for potato (3 lb ai/ A ground application granular, soil incorporation) 12 EEC is estimated to be the same as for cotton (1 lb ai/ A ground application of liquid when injected = approx. zero) Based on the data described above, freshwater invertebrates are at greater chronic risk than fish or estuarine invertebrates. 28 Risks to Nontarget Organisms from the use of Disulfoton 15 on Christmas Trees in North Carolina The use of Disulfoton 15 G in Christmas tree farms at this time can not be modeled for potential surface water contamination. EFED assumes the estimated concentration for the North Carolina 24 (c) use pattern ­­ 4.5 lbs ai/ A unincorporated ­­ may be similar to the values for the single 4.0 lb ai/ A incorporated application of granular disulfoton to tobacco. Based on this assumption there is potential for acute risk and chronic to aquatic invertebrates and chronic risk to freshwater fish. This assumption would be more likely when the receiving body of water is a pond, rather than a stream. The Christmas tree use pattern has a higher rate than tobacco; the granules are unincorporated; and current cultural practices recommend maintaining vegetation under the trees and between the rows. Therefore while the first two conditions may increase the estimated concentrations above those for tobacco, the third condition may reduce the concentrations as the absence of soil erosion reduces the amount of disulfoton moving off site. Since this preliminary screen of the 24( c) exceeds levels of concern, the Sec 3 use at 59.7 lbs ai/ A would exceed (perhaps by 20 fold) the same levels of concern for aquatic life as well as the acute risk for fish. The North Carolina Christmas tree industry has provided information that has contributed to a refinement of EFED's risk assessment for aquatic organisms from Christmas tree farming. First, the nearly exclusive use for Disulfoton 15 G on Christmas trees throughout the United States is on Fraser fir grown in 6 counties in Western North Carolina, thereby localizing the exposure and precluding any estuarine exposure. Second, the primary aquatic sites adjacent to tree farms are streams, not ponds. Residues in these streams will be lower and of shorter duration than would be expected for a pond. Third, two rapid assessment macro invertebrate surveys of streams in the Western region of North Carolina have been submitted. These studies show that when conservation measures associated with Christmas tree farming in the Western counties of North Carolina are implemented, there may be only slight, short term impact to aquatic macro invertebrates from disulfoton use. The Agency concurs with the investigators that when implementing (but not limited to) conservation measures such as establishing ground cover throughout the farm, constructing and maintaining the fewest number of roads and bridges, creating a riparian zone to include vegetation and trees and employing Integrated Pest Management practices, there appears to be " ... little negative effect on the fauna of adjacent streams...." The slight negative effect that was observed seemed to impact stoneflies (Plecoptera) more than the two other orders– caddisflies (Trichoptera) and mayflies (Ephemeroptera) ­ that were the focus of the survey. In conclusion, aquatic macro invertebrates appear to have the capacity to recover from impacts that could be caused by disulfoton use on Christmas trees in Western North Carolina. (e) Nontarget Plants EPA was unable to conduct a risk assessment for nontarget plants due to a lack of test data. Nontarget plant testing was not required for disulfoton because it is not a herbicide. r, the Di­ Syston 8 EC label contains phytotoxicity statements suggesting a potential risk to nontarget plants. Therefore Tier 1 seedling emergence (850.4100) and Tier I vegetative vigor (850.4150) are requested to support the liquid formulations of disulfoton. (f) Endangered Species 29 For disulfoton, EPA has risk concerns for the following scenarios: avian acute, avian chronic, mammalian acute, mammalian chronic, freshwater fish acute, freshwater invertebrate acute, freshwater invertebrate chronic, marine/ estuarine fish acute, marine/ estuarine fish chronic, marine/ estuarine invertebrate acute, and marine/ estuarine invertebrate chronic. Endangered terrestrial, semi­ aquatic and aquatic plants also may be affected, based on label statements indicating phytotoxicity. The Agency has developed the Endangered Species Protection Program to identify pesticides whose use may cause adverse impacts on endangered and threatened species, and to implement mitigation measures that address these impacts. The Endangered Species Act requires federal agencies to ensure that their actions are not likely to jeopardize listed species or adversely modify designated critical habitat. To analyze the potential of registered pesticide uses to affect any particular species, EPA puts basic toxicity and exposure data developed for REDs into context for individual listed species and their locations by evaluating important ecological parameters, pesticide use information, the geographic relationship between specific pesticides uses and species locations, and biological requirements and behavioral aspects of the particular species. This analysis will include consideration of the regulatory changes recommended in this RED. A determination that there is a likelihood of potential impact to a listed species may result in limitations on use of the pesticide, other measures to mitigate any potential impact, or consultations with the Fish and Wildlife Service and/ or the National Marine Fisheries Service as necessary. At present, the program is being implemented on an interim basis as described in a Federal Register notice (54 FR 27984­ 28008, July 3, 1989). A final program, which may be altered from the interim program, will be proposed in a Federal Register notice scheduled for publication in autumn of 2001. (g) Ecological Incident Reports Several reports of wildlife poisonings are associated with disulfoton. These poisoning incidents are summarized in Table 16 below. Some of these incident reports support EPA's concerns for acute risk. 30 Table 16. Chronological List of Ecological Incidents Start Date Misuse? (yes/ no/ un known) Incident Description 6/ 12/ 95 unknown Johnston County, NC: Fish kill occurred in commercial fish pond. Crop fields nearby treated with pesticides. Water, soil and vegetation samples analyzed for a variety of pesticides. Disulfoton, as well as several other pesticides, was found at 0.2­ 2.5 ppm in vegetation samples. Possible certainty index for disulfoton. (Incident Report No. I003826­ 002). 1/ 24/ 94 unknown Puerto Rico: 6 grackles fell dead from tree in yard of private residence. Dead heron and owl also found in vicinity. Use site and method not reported. Birds had depressed acetyl cholinesterase. Analysis of GI contents of a grackles showed disulfoton at 2.37 ppm wet weight. Highly probable certainty index for disulfoton. (Incident Report No. I003966­ 004). 6/ 11/ 94 unknown Arapahoe CO: Fish kill following application of Di­ Syston EC. to wheat just before heavy rain. Water samples contained disulfoton sulfoxide at 29.5­ 48.7 ppb and disulfoton sulfone at 0.0199­ 0.214 ppb. (Incident Report No. I001167­ 001). 6/ 18/ 93 No Young County, TX: 18 Swainson's hawks dead, 1severely disabled in a cotton field. Cotton seed had been treated with disulfoton prior to planting, ~10 days before the birds were discovered. No additional applications of OP or carbamate pesticides made in vicinity of field. Autopsies showed no trauma or disease. Lab analysis showed insect material in GI tracts; this material contained disulfoton (~ 7 ppm); no other OP or carbamate insecticides were present. Hawks fed on insects, which had been feeding on the young cotton plants, which contained disulfoton residues. (L. Lyon, Div. of Environmental Contaminants, U. S. Fish and Wildlife Service, Arlington, VA.) 6/ 22/ 91 unknown Onslow County, NC: Fish kill in pond at private residence. Pond received runoff from neighboring tobacco field; pondwater analysis showed disulfoton and several other pesticides, including endosulfan. Disulfoton sulfoxide found in water at 0.32 ppb. Endosulfan had highest concentration (1.2 µg/ L), and is toxic to fish, but disulfoton cannot be ruled out as a possible cause of death. No tissue analysis. Possible certainty index for disulfoton. (Incident Report No. B0000216­ 025). 4/ 26/ 91 unknown Sussex County, DE: 9 American robins dead following application of granular disulfoton at tree nursery. Corn and soybeans also in vicinity. No laboratory analysis. Probable certainty index for disulfoton. (Incident Report No. I000116­ 003).

epa

2024-06-07T20:31:41.696990

regulations

EPA-HQ-OPP-2002-0055-0012

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM January 24, 2002 SUBJECT: Endangered Species addendum to EFED's Disulfoton Science Chapter FROM: Henry Craven, Biologist EFED Thomas Steeger, Acting Branch Chief ERB 3, EFED Larry Turner, Mammalogist FEAD Arty Williams, Branch Chief EFB, FEAD TO: Christina Scheltema, Chemical Review Manager SRRD This memo reflects EFED's consultation with FEAD and presents the results of a preliminary assessment for potential risk to endangered birds and mammals from disulfoton's use in the following situations: Asparagus­­ foliar application of liquid in CA and WA Barley ­­ foliar application of liquid in CO, ID, MT and WA Christmas trees ­­ spot broadcast of granular in NC Coffee ­­ spot broadcast of granular in Puerto Rico Cotton ­­ in furrow application of granular and liquid in LA, MO, OK, NC and SC Potatoes ­­ foliar application of liquid in ID and WA Wheat ­­ foliar application of liquid in KY Appended to this memo are two print outs from OPPs Endangered Species data base that compares USDA's Agriculture Census information on crop and county overlap with USFWS information on the location of endangered species to the county level. One print out applies to Christmas trees in N Carolina and the second is for the other crops (except coffee) and states. Since the data base does not include information on Puerto Rico, Larry Turner had personal communication with Felix Lopez, Environmental Contaminants Specialist USFWS, Tel #. 787­ 851­ 7297 (ext. 26). The results of a cursory screen of the two print outs and the phone call are as follows: Two species were identified as possibly needing some form of mitigation. These species are the Puerto Rican plain pigeon in coffee plantations and the Mountain plover in barley fields. Puerto Rico has no endangered mammals, however two endangered ground feeding birds, i. e. Yellow shouldered blackbird and Puerto Rican plain pigeon, could consume granules as grit. Only the Puerto Rican plain pigeon utilizes coffee plantations. Puerto Rico is divided up politically into 72 municipalities. The Puerto Rican plain pigeon resides in 5 municipalities of which 4, i. e. Cayey, Cidra, Comerio, Utuado, contain coffee plantations. Utuado has ~7500 acres of coffee, which is about 1/ 4th the area of the municipality; the other three have less than 100 acres each. Mitigation could be assured by off labeling for the 4 municipalities. There was no county overlap between asparagus in Washington and California and endangered species. With respect to disulfoton use on barley, only the Mountain plover is at potential risk from ingesting soil invertebrates in soil that has been sprayed directly or received wash off from the foliage. However, residues would likely be lower than what would be required to cause an adverse effect. The overlap between the number of counties where barley is grown and the bird may occur includes 14 in Colorado and 17 in Montana. Additionally, like other plovers, the bird prefers unvegetated, open areas; if the barley is taller than 3 inches before it is sprayed there is little likelihood the bird would utilize the field. Therefore, a label statement limiting application of disulfoton to when the crop is at least 3 inches tall could provide a reasonable measure of mitigation of risk from disulfoton exposure. Finally, the species has been proposed, but is not officially listed as endangered. Regardless of the status, OPP needs to be aware of the potential for exposure. Although carnivorous birds (ie. owls and eagles) and mammals (ie. Black­ footed ferret, grizzly, Gray wolf and Red Wolf) were located in the same counties as all crops except coffee, they are not at risk because secondary poisoning studies on representatives from these two classes did not indicate concern. Several crops such as cotton, wheat and Christmas trees were located in the same counties as endangered bats. However bats are not at risk from disulfoton sprays as they would only be feeding on flying insects from dusk to dawn. If spraying is restricted to daylight hours, bats would not be exposed to disulfoton. Bats would not be exposed to granules. With respect to Christmas trees in North Carolina, in addition to some of the organisms stated above there are several birds and mammals which although they could be in or around the vicinity of Christmas tree plantations are not considered at risk especially from use of granules. The Wood Stork feeds on fish and the Piping plover resides on sand bars and feeds on aquatic invertebrates; therefore neither of these species are likely to be impacted. Because disulfoton is systemic, there is a slight potential for low, undetermined dietary exposure to the Northern flying squirrel and the Red­ cockaded woodpecker. The squirrel consumes organisms, i. e. lichens, fungi and insects, or plant parts, i. e. buds and seeds that could take up disulfoton residues from the xylem. However as the squirrel is a cavity nester it prefers tall deciduous trees to conifers in the same proximity. The woodpecker requires old growth (at least 60 years) living pine trees in which to make cavities; they feed on insects found under the bark of conifers where the trunk is larger and more accessible than in young Christmas trees. Concerning uses other than Christmas trees and coffee the following endangered species are forest dwellers and are not associated with agricultural sites: Northern Idaho Ground Squirrel, Marbled murrelet (feeds on fish), Woodland caribou, Brown Pelican (feeds on fish), Red cockaded woodpecker, Carolina northern flying squirrel, Preble's meadow jumping mouse (resides in high elevation meadows). These species would not be considered at risk. In addition to the forest dwellers, Wood storks feed on fish, Whooping cranes feed on aquatic invertebrates, Black capped vireos reside in scrub areas and feed on flying insects, Piping Plovers reside principally on sand bars and feed on aquatic invertebrates, and Idaho ground squirrels inhabit meadows. These species would not be considered at risk. Considering the biology of the species mentioned above and the specific recommendations to avoid exposure of disulfoton to the Puerto Rican plain pigeon and the Mountain plover, we believe there will be no effect on threatened and endangered species.

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EPA-HQ-OPP-2002-0055-0013

Supporting & Related Material

Memorandum From: Larry Turner, Ph. D. Environmental Field Branch Field and External Affairs Division Thru: Arty Williams, Chief Environmental Field Branch Field and External Affairs Division To: Christina Scheltema Reregistration Branch III Special Review and Registration Division Subject: Puerto Rican Plain Pigeon and Disulfoton In our files and databases, the Puerto Rican Plain Pigeon is indicated to occur in several municipalities in Puerto Rico where coffee is grown. The municipality of Utuado had thousands of acres of coffee. When we initially contacted the Fish and Wildlife Service in Puerto Rico, it was indicated to us that the pigeon did occur in Utuado and several other municipalities where smaller amounts of coffee are grown. However, in an April 18, 2002 phone conversation with Marelisa Rivera, endangered species specialist with the Puerto Rico office of the Fish and Wildlife Service, we were informed that our information was old. The pigeon no longer occurs in coffee growing areas. With no exposure, there will be no effect. Therefore, there is no need to provide special protection for this species from disulfoton. According to Ms. Rivera, the Puerto Rican sharp­ shinned hawk, Puerto Rican broad­ winged hawk, and the Puerto Rican boa are the only listed animals that occur in coffee. These three species all feed on bats, mice, and birds. Since there are data indicating a lack of secondary hazards for disulfoton, there will be no effect on these species from disulfoton. cc: Harry Craven, EFED

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2024-06-07T20:31:41.709329

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EPA-HQ-OPP-2002-0055-0014

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES TO: Christina Scheltema Betty Shackleford Michael Goodis Special Review and Reregistration Division (7508C) FROM: James Wolf ERB3 Environmental Fate and Effects Division (7507C) DATE: November 20, 2001 RE: Disulfoton residues in ground water found in the Virginia BMP Study: BMP Impacts on Nitrate and Pesticide Transport to Groundwater in the Nomini Creek Watershed. Final Report Report No. NC­ 0298 S. Mostaghimi, S. Shukla, and P. W. McClellan. 1998. Biological Systems Engineering Department Virginia Polytechnic Institute and State University Blacksburg, VA # The ground water monitoring component was started in 1986 and ended in June, 1997. # Nomini Creek Watershed is located in Westmoreland County, Va. The 1463 ha watershed has typical Coastal Plain land use 49% cropland, 47% woodland, and 4% used for homestead and roads (different reports has slightly different breakdown, but have the same major uses). Average annual precipitation is 102 cm, with most of the rainfall occurring between April and September. Most ground water recharge occurs in late Fall or early spring. # Nomini Creek Watershed is located in the Coastal Plain Physiographic providence. Soils, geology and topography are similar to the of the unglaciated Atlantic Coastal Plain. 2 Soils are mostly Ultisols. The major soil series are Suffolk and Rumford. These soils cover 91 percent of the area and have similar physical properties. Soil Taxonomy Sulfolk Coarse­ loamy, siliceous, thermic Typic Hapudults Rumford Coarse­ loamy, siliceous, thermic Typic Hapudults The Coastal Plain has been identified as a vulnerable area to ground water contamination. Other vulnerable regions have also been identified. The soils could also be used to identify possible problem areas. (Can't be done by tomorrow). These are vulnerable soil for leaching. # Agriculture is primarily row crops. Major crops are corn, soybeans, and small grains (wheat and barley). Typical rotation is conventionally­ tilled corn, followed by small grains with no­ till soybeans planted in the small grain residues. Occasionally, full season, conventionally­ tilled soybeans is also grown. USDA Ag Statistics do not report tobacco production for Westmoreland County. Potatoes are reported to be produced, but production appears to be declining. # Study Objective to study the quality of surface and ground water as influenced by the agricultural practices in the watershed. # Monitoring consisted of two (2) runoff and surface water monitoring stations; seven rain gauges; one weather station; and eight (8) ground­ water monitoring wells (GN1 to GN8). The ground water wells were located primarily in agricultural areas. These wells were drilled in pairs, 100 ­ 150 meters apart, with one in pair located hydraulically downgradient of the other. Characteristic (m) Value Well GN1 GN2 GN3 GN4 GN5 GN6 GN7 GN8 Well depth 13.7 12.8 15.2 13.7 16.5 12.0 15.8 11.9 GW depth Mean 10.3 9. 6 13.1 9. 4 12.9 8. 2 13.3 8. 6 " Max. 12.0 10.8 14.0 12.7 13.9 9. 1 14.4 9. 6 " Min 8. 5 7.1 11.5 7. 0 11.3 7. 0 11.8 7. 4 # Approximately monthly samples were taken from each monitoring well and analyzed for a number of analytes including 22 pesticides. QA/ QC procedures were followed. 3 # Herbicide and insecticide application information in the watershed were obtained from farmer surveys. The rate and time of herbicide application was dependent on the crop rotation adopted by the farmer. Corn is usually planted between late April and early May. Post­ emergence sprays applications occur in early July. The timing and application rates of insecticides, applied individually or in combination, in the watershed depending on the type and extent of the insect problem observed. Note: the label does allow for fall application to wheat. Perhaps fall application and greater fall recharge resulted in the observed concentration (2.87 µg/ L). Possible mitigation option? # Disulfoton sampling results and detection statistics in the Nomini Creek Watershed (Table 15, after Mostaghimi, 1998). These are disulfoton parent. Pesticide Total Samples Detections 1 Detection 2 Frequency (percent) Concentration (µg/ L) Max Mean SD Disulfoton 1010 10 1.0 2.87 0.39 0.32 Pre­ BMP 3 (5/ 86 ­ 10/ 88) 229 7 3.1 2.87 0.52 Post BMP 4 (11/ 89 ­ 9/ 96) 693 3 0.4 0.10 0.08 1 Number of samples with detectable levels of pesticide 2 (samples with detectable levels of pesticide * 100)/ total number of samples 3 Before agricultural Best Management Practice (BMP) implemented in watershed. 4 Following the implementation of BMP within the watershed. Note: I only had (raw) data through 1990. Thus, I only had 6 of the 10 detections, mean was 0.57 µg/ L, which is only slightly greater than the mean with 7 samples (pre­ BMP). Disscussion and recommendation: The following table was included in Feb. 7, 2000 Additional Clarification of Disulfoton GroundWater Monitoring Data Assessment. In a recent discussion about a "chronic" exposure for ground water the following suggestions was put forth (mean = 1.49 µg/ L = (2.87 +0.1)/ 2 for well site GN3. Considering there are many "monthly samples, with most being less than the detection limit, a lower mean is probably justified (disulfoton parent only). The mean of all the detections is 0.39 µg/ L, the mean of the pre­ BMP is 0.52 µg/ L, and post­ BMP is 0.08 µg/ L. Without specifically estimating a concentration, I think that as far as parent disulfoton goes, the average concentration would be expected to be considerably less than the DWLOC of 1.2(?). 4 Summary of Disulfoton Detections in ground water from the eight ground­ water monitoring wells in Nomini Creek Watershed (Virginia), during 1986 and 1987. Sampling Date Well­ Site Number Concentration (µg/ L) 11/ 5/ 86 GN3 2.87 11/ 5/ 86 GN6 0.04 3/ 13/ 87 GN4 0.10 8/ 20/ 87 GN1 0.13 8/ 20/ 87 GN2 0.16 8/ 20/ 87 GN3 0.10

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2024-06-07T20:31:41.711810

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EPA-HQ-OPP-2002-0055-0015

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES PC Code: 032501 CHEMICAL: Disulfoton DP Barcode: D280670A March 7, 2002 MEMORANDUM TO: Betty Shackleford, CRM Christina Scheltema, PM Team Reviewer Michael Goodis Reregistration Branch 3 Special Review and Reregistration Division (7508W) FROM: James K. Wolf, Ph. D., Soil Scientist Environmental Risk Branch 3 THRU: Kevin J. Costello, Acting Branch Chief Environmental Risk Branch 3 Environmental Fate and Effects Division (7507C) SUBJECT: Correction to the Disulfoton: Summary of Estimated Drinking Water Concentrations (EDWCs) use in the Human Health Risk Assessment memo DP Barcode: D280670, date February 25, 2002. Footnote number 2 for Table 1 (page 2) is incorrect. It should be Barley with 1.0 lb ai/ A application has an EDWC that is (1.00/ 0.83) larger than the 0.83 lb ai/ A application. The difference between the to the two granular, soil applied barley estimates the difference in application rate (0.83 lb ai/ A compared to 1.0 lb ai/ A). Both used the same PCA value of 0.87. The incorrect footnote is as follows: Barley with 1.0 lb ai/ A application has an EDWC that is (1.0/ 0.87) larger than the 0.87 lb ai/ A application.

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2024-06-07T20:31:41.714496

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EPA-HQ-OPP-2002-0055-0016

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES PC CODE: 032501 CHEMICAL: Disulfoton DP Barcode: D280670 MEMORANDUM February 25, 2002 SUBJECT: Disulfoton: Summary of Estimated Drinking Water Concentrations (EDWCs) use in the Human Health Risk Assessment. TO: Betty Shackleford, PM 53 Christina Scheltema, PM Team Reviewer Michael Goodis Reregistration Branch 3 Special Review and Reregistration Division (7508W) FROM: James K. Wolf, Ph. D., Soil Scientist Environmental Risk Branch 3 THRU: Kevin J. Costello, Acting Branch Chief Environmental Risk Branch 3 Environmental Fate and Effects Division (7507C) This memo summarizes the Tier II estimated drinking water concentrations (EDWC) for disulfoton in surface water for use in human risk assessment. Tier I ground water concentrations are also presented. The drinking water assessment considers both parent disulfoton and total disulfoton residues (TDR, the sum of disulfoton, D. sulfoxide, and D. sulfone) as these degradates were included in the HED human risk assessment. The EDWCs considered by HED in the human risk characterization (i. e., surface water peak, annual mean, and long term mean) are summarized by crop and management practice in Table 1. The parent disulfoton and TDR 2 concentrations for the cotton scenario are also given using the default "for all agricultural " crops (0.87) PCA factor, because all uses have not been modeled. The cotton scenario, with the 0.87 PCA, is given as to represent an upper end exposure site. Table 1. Tier II Estimated Drinking Water Concentrations (EDWC) for parent disulfoton and total disulfoton residues (sum of parent disulfoton and D. sulfone and D. Sulfoxide) by crop in Index Reservoir and PCA 1 . Crop (PCA) Application Rate (lb ai/ A) and Method Number of Applications/ Interval (days) Concentration ( : g/ L) Peak parent/ total Annual Average parent/ total Long­ term Average parent/ total Barley (0.87) 1.0 foliar 2 15.51/ 34.53 1.61/ 7.62 0.95/ 4.21 Barley (0.87) 0.83 granular, soil applied 2 12.96/ 33.96 1.06/ 8.70 0.44/ 4.72 Barley (0.87) 1.0 2 granular, soil applied 2 14.88/ 39.05 1.22/ 10.01 0.51/ 5.42 Cotton (0.20) 1.0 ground and soil 1 7. 21/ 12.59 0.40/ 1.96 0.12/ 1.05 Cotton (0.87) 3 1.0 ground and soil 1 31.35/ 54.76 1.73/ 8.53 0.52/ 4.57 Potatoes (0.87) Western states 3.0 ground and soil 1 6. 89/ 12.53 0.46/ 4.77 0.39/ 3.71 Potatoes (0.87) East of Rockies 1.0 foliar 3 13.09/ 34.37 1.09/ 16.72 0.94/ 9.49 Spring Wheat (0.56) 0.75 foliar 1 2. 79/ 8.02 0.24/ 2.39 0.19/ 1.82 1 PCA = 0.87 for barley and potatoes, 0.56 for spring wheat, 0.20 for cotton, and 0.87 all agricultural land. One cotton scenario the PCA is assumed to be 0.87. 2 Barley with 1.0 lb ai/ A application has an EDWC that is (1.0/ 0.87) larger than the 0.87 lb ai/ A application. 3 The Agency default PCA for cotton is 0.20. Cotton without an adjustment for PCA, or 0.87, would overestimated the EDWC. In Table 1, the peak surface water EDWC represents the upper 1­ in­ 10­ year peak event concentration, the surface water annual EDWC represents the upper 1­ in­ 10 year mean annual concentration, and the long term EDWC is the overall average for the entire simulation. The EDWCs are based on linked PRZM and EXAMS models, with the Percent Crop Area (PCA) and Index Reservoir (IR), while using the label maximum rate and number of applications, and the 3 shortest re­ application interval. Note, the cotton is shown with a PCA of 0.87 to represent an upper end exposure site. SCI­ GROW and monitoring data was used to estimate ground water concentrations (Table 2). Table 2. Ground­ water concentrations. Method Application rate/ number 1 Concentration ( : g/ L) Parent disulfoton Total Disulfoton Residues SCI­ GROW (modeled) 3.0 lb ai/ ac/ 1 0.02 1.19 Monitoring Mostaghimi, 1998 mean = 0.39 2 (range 0.04 to 2.87) not measured " NAWQA 0.010 to 0.060 not measured " WI DNR 4.0 to 100.0 not measured 1 Cotton use rate, maximum use rate for major crops. 2 Overall mean of data. The PRZM/ EXAMS estimated disulfoton residue concentrations in surface water appear to be strongly related to the application rate, number of applications, application interval, and method of application and timing to application to rainfall events. Everything else being equal, several management factors had an effect on the estimated drinking water concentrations. One factor was the application rate, a second was the application method (spray drift and depth of incorporation). A third factor was the percent cropped area (PCA). These values were set as presented to the SAP (Jones and Abel, 1997; Jones et al., 2000). The application rate and PCA result in linear differences in estimated concentrations (e. g., double the rate the EDWC doubles). Increasing the depth of incorporation also lowered the EDWCs. Method of application and formulation also influenced the EDWCs; the granular formulation essentially has no spray drift while for aerial applications drift can be significant. Summary and Conclusions: The models used by EFED show that disulfoton and degradates will be found in runoff. Non­ targeted monitoring has found disulfoton and disulfoton degradates in surface water. However, the fate of disulfoton and its degradates once in surface water and sediments, and the likely concentrations therein, cannot be modeled with a high degree of certainty since data are not available for the aerobic and anaerobic aquatic degradation rates. Surface water concentrations of disulfoton and total disulfoton residues were estimated by using linked PRZM3 and EXAMS models using several different scenarios (barley, cotton, potato, and spring wheat). The large degree of latitude available in the disulfoton labels also allows for a wide range of possible application rates, total amounts, application methods, intervals between applications and 4 application date( s). The relatively rapid rate of microbial degradation in the soil (< 20 day aerobic soil metabolism half­ life) and direct aquatic photolysis, suggests that disulfoton parent can degrade fairly rapidly in surface water. Although there is a lack of some environmental fate data for the degradates, the assessment suggests that the degradates will reach higher concentrations than the parent because they are more persistent and probably more mobile. The estimated drinking water concentrations (EDWC) for parent disulfoton and total disulfoton residues for different crops were determined using the IR and PCA concepts (Table 1). The peak concentrations of disulfoton in the IR appear capable of being quite high, with 1­ year­ in 10 peak surface water concentrations of 2.79 to 15.51 µg/ L and annual mean concentrations of 0.24 to 1.61 : g/ L for the parent compound. The mean EDWCs of the annual means of disulfoton ranged from 0.12 to 0.95 : g/ L. Although, there is a lack of some environmental fate data for the degradates, the assessment suggests that the degradates will reach higher concentrations than the parent because they are more persistent and probably more mobile. The estimated 1­ in­ 10 year peak concentrations for the total disulfoton residues in the IR ranged from 8.02 to 34.53 : g/ L and annual mean ranged from 1.96 to 16.72 : g/ L, and the mean of the annual means ranged from 1.05 to 9.49 : g/ L. These estimated concentrations were highly influenced by the value PCA value. The PCA values have been estimated by OPP for spring wheat (0.56) and cotton (0.20). The default for value for all agricultural land of 0.87 was used for the barley and potatoes scenarios. Better estimates of the PCA for these crops would reduce the uncertainty associated with the estimated drinking water concentrations. The parent disulfoton and TDR concentrations for the cotton scenario are also given with all agricultural land PCA factor being factored in for one of the cotton scenarios (Table 1). Because all uses have not been modeled, the cotton scenario, the all agricultural land PCA, is given as to represent an upper end exposure site. The EDWC values for disulfoton parent have less uncertainty than the total residue, because there is more certainty surrounding the "estimated" aerobic aquatic metabolism half­ life for the estimated aerobic aquatic half­ life for the total disulfoton residues. It is recommended that the Virginia data be considered in the "quantitative" drinking water assessment for ground water exposure. The Wisconsin data should be noted and addressed more qualitatively. Highly vulnerable areas, such as the Central Sand Plain, do not represent the entire use area and can probably be better mitigated or managed a local or state level. Specifically, it is recommended that the 1.2 : g/ L be used for acute and chronic exposure from ground water (see Table 2). Based upon the fate properties of disulfoton, the sulfoxide and sulfone degradates (more persistent and probably more mobile) have a greater probability of being found in ground water. The Agency has requested more data on the mobility and persistence of the disulfoton sulfone and sulfoxide degradates. Depending upon the results of the mobility studies, a ground water study (ies) may be required to better assess the potential exposure from the degradates (and also parent). Monitoring Data 5 Surface­ water samples were collected in a study to evaluate the effectiveness of Best Management Practices (BMP) in a Virginia watershed. Approximately half of the watershed is in agriculture and the other half is forested. The detections of parent disulfoton in surface­ water samples ranged from 0.037 to 6.11 : g/ L and fell within an order of magnitude with the estimated environmental concentrations (EECs) obtained from the PRZM/ EXAMS models. The surface­ water monitoring in the USGS in the NAWQA (USGS, 1998) project found relatively few detections of parent disulfoton in surface water with a maximum concentration of 0.060 : g/ L. Degradates were not included in the NAWQA study. In a separate study, disulfoton degradates were, however, reported in surface water, when a rainfall event occurred following application to wheat, where fish kills occurred; pesticide residue concentrations ranged from 29.5 to 48.7 : g/ L for D. sulfoxide and 0.02 to 0.214 : g/ L for D. sulfone (Incident Report No. I001167­ 001). The wheat field was located several miles from the pond. The volume of run off water raised the level of the pond fifteen feet. The PRZM/ EXAMS estimates of peak TDR correspond fairly well with the levels noted above in the fish kill incident. EFED also made inquires to all fifty states concerning the whether there had been any monitoring for organophosphates pesticides in ground water and surface water as part of the cumulative assessment. (http:// www. epa. gov/ pesticides/ cumulative/ pra­ op/ iii_ e_ 3­ f. pdf). The following states conducted monitoring which included parent disulfoton: HI, KS, KT, MD, MI, NE, NC, WV, WI, and WY. There were no detections reported. Surface­ and ground­ water monitoring data available in STORET were evaluated in detail, but were generally not considered due to limitations associated with high detection limits and difficulty in interpreting the data. About 50 percent of the well samples reported in STORET as <1 : g/ L (low range) of disulfoton residues and the other 50% were reported as < 250 : g/ L (high range). Therefore, the specific concentration of the well is not indicated. The low range wells could have concentrations from zero to 0.99 : g/ L), while the high range could have concentrations from zero to 249.99 : g/ L. Disulfoton concentrations were simply given as less than a value. Thus, considerable uncertainty exists with respect to the STORET monitoring data. A pilot reservoir monitoring study was initiated by USEPA Office of Pesticide Programs, Environmental Fate and Effects Division (USEPA/ EFED/ OPP), USEPA Office of Ground Water and Drinking Water (USEPA/ ODWGW/ OPP), and the USGS National Water Quality Assessment (USGS/ NAWQA) to assess pesticide concentrations in raw and finished drinking water. (http:// www. epa. gov/ pesticides/ cumulative/ pra­ op/ iii_ e_ 3­ f. pdf). Disulfoton, and disulfoton sulfone and disulfoton sulfoxide were included in the study. Parent disulfoton was not detected (limit of detection = 0.005 : g/ L). Degradates disulfoton sulfone were detected (0.013 : g/ L) in 1 of 316 samples (LOD = 0.005 : g/ L) and disulfoton sulfoxide (0.006 : g/ L) in 1 of 316 samples( LOD = 0.016 : g/ L). While this pilot study does not allow for a definitive assessment of potential disulfoton residues in drinking water, it does show that the degradates can be found in drinking water sources. No disulfoton residues were detected in the finished water samples. More detail can be obtained from the draft Cumulative Risk Assessment for Organophosphates. 6 Water Resources Assessment i. Summary and Conclusions The Tier II modeling of disulfoton residue concentrations in surface water used the PRZM3 and EXAMS models as applied to barley, cotton, potatoes, and spring wheat, using maximum label application rates and several application methods (Table 1). The Tier II EEC assessment uses a single site, or multiple single sites, over multiple years which represents a high­ end exposure scenario from pesticide use on a particular crop or non­ crop use site for ecological exposure assessments. The EECs for disulfoton were generated for multiple crop scenarios using PRZM3.12 (Carsel, 1997; 5/ 7/ 98) which simulates the erosion and run­ off from an agricultural field and EXAMS 2.97.5 (Burns, 1997; 6/ 13/ 97) which simulates the fate in a surface water body. Each scenario, or site, was simulated for 20 to 40 (depending on data availability) years. The sites selected generally were the EFED (standard scenarios) to represent a reasonable "at risk" soil for the region or regions being considered. The scenarios selected represent highend exposure sites. The sites are selected so that they generate exposures larger than for most sites (about 90 percent) used for growing the selected crops. An "at risk" soil is one that has a high potential for run­ off and soil erosion. Thus, these scenarios are intended to produce conservative estimates of potential disulfoton concentrations in surface water. The crop, MLRA, state, site, and soil conditions for each scenario are given in Tables 3 and 4. The SCI­ GROW (Screening Concentration in Ground Water) screening model developed in EFED (Barrett, 1997) was used to estimate potential ground water concentrations for disulfoton parent and total disulfoton residues under "generic" hydrologically vulnerable conditions. SCI­ GROW provides a screening concentration, an estimate of likely ground water concentrations if the pesticide is used at the maximum allowed label rate in areas with ground water exceptionally vulnerable to contamination. In most cases, a majority of the use area will have ground water that is less vulnerable to contamination than the areas used to derive the SCIGROW estimate. ii. Application Rates Used in Modeling Disulfoton application rates (Table 1) selected for use in the modeling scenarios were based upon information submitted by the registrant, analysis conducted by BEAD, and the disulfoton (Di­ Syston) labels. Three factors were considered when selecting the application rate: 1) the labels range of allowable application rates; 2) the number of applications; and 3) the application interval. The maximum rate (ounces or pounds a. i. per crop simulated), maximum number of applications, and the shortest application intervals were selected. iii. Modeling Scenarios 7 Surface Water: The disulfoton scenarios (Tables 3 and 4) are representative of high run­ off sites for barley in the Southern Piedmont of Virginia (MLRA 136), cotton in the Southern Mississippi Valley Silty Uplands of Mississippi (MLRA 134), potatoes in the New England and Eastern New York Upland of Maine (MLRA 144A), and spring wheat in the Rolling Till Prairie of South Dakota (MLRA 102A). The wheat scenario was selected because of high disulfoton use on wheat in South Dakota was high. Soils property data (Table 4) and planting date information were obtained from the EFED Standard Scenarios or the PRZM Input Collator (PIC) data bases (Bird et al, 1992). The Percent Crop Area (PCA) values used for the four scenarios for estimated drinking water concentrations are also given in Table 3. 8 Table 3. Crop, location, soil and hydrologic group for each modeling scenario. Crop MLRA 1 State Soil Series Soil Texture Hydrologic Group Period (Years) PCA 2 Barley 136 VA Gaston sandy clay loam C 270. 87 Cotton 131 3 MS Loring silt loam C 20 0. 20 Potatoes 144A ME Paxton sandy loam C 36 0. 87 Spr. Wheat 102A SD Peever clay loam C 40 0. 56 1 MLRA is major land resource area (USDA, 1981). 2 PCA is the Percent Crop Area. 3 Meteorological file met131. met is used in the EFED standard cotton scenario, since the weather station is closer to the simulated site then met134. met. Table 4. Selected soil properties used modeling. Soil Series (MLRA) Depth (in) Bulk Density (g/ cm 3 ) Organic Carbon (%) Field Capacity (cm 3 /cm 3 ) Wilting Point (cm 3 /cm 3 ) Gaston (136) 16 1.6 1. 740 0.246 0.126 84 1.6 0. 174 0.321 0.201 50 1.6 0. 116 0.222 0.122 Loring (131) 10 1.6 1. 160 0.294 0.094 10 1.6 1. 160 0.294 0.094 105 1.8 0. 174 0.147 0.087 Paxton (144A) 20 1.6 2. 90 0. 166 0.66 46 1.8 0. 174 0.118 0.38 34 1.8 0. 116 0.085 0.035 Peever (102A) 18 1.35 1.740 0.392 0.202 82 1.60 0.116 0.257 0.177 50 1.60 0.058 0.256 0.176 Ground Water: The SCI­ GROW (Screening Concentration in Ground Water) screening model developed in EFED (Barrett, 1997) was used to estimate potential ground water concentrations for disulfoton parent and total disulfoton residues under "generic" hydrologically vulnerable 9 conditions, but not necessarily the most vulnerable conditions. The SCI­ GROW model is based on scaled ground water concentrations from ground water monitoring studies, environmental fate properties (aerobic soil half­ lives and organic carbon partitioning coefficients­ Koc's) and application rates. iv. Modeling Procedure Environmental fate parameters used in PRZM3 and EXAMS runs are summarized in Table 5. A site specific Index Reservoir was used for each scenario. The PRZM3 simulations were run for a period of 36 years on potatoes, beginning on January 1, 1948 and ending on December 31, 1983. Barley was run for 27 years (1956­ 1983) and spring wheat was run for 40 years (1944­ 1983). Cotton was run for 20 years of data (January 1, 1964­ December 31, 1983). Scenario information is summarized in Tables 4 and 5. 10 Table 5. Disulfoton fate properties and values used in (PRZM3/ EXAMS) modeling. Parameter Value Source Molecular Weight 274.39 MRID 150088 Water Solubility 15 mg/ l @20 MRID 150088 Henry's Law Coefficient 2. 60 atm­ m3/ mol EFED One­ liner 05/ 21/ 97 Partition Coefficient (Koc) 551.5 (mean of 4 ) MRID 43042500 Vapor Pressure 1.8E­ 04 mmHg EFED One­ liner 05/ 21/ 97 Hydrolysis Half­ lives @ pH 4 pH 7 pH 9 1174 days 323 " 231 " MRID 143405 Hydrolysis Rate Constants (needed for EXAMS derived from Hydrolysis halflives Kah = (negative) Knh = 8.88E­ 05 Kbh = 3.58 Aerobic Soil Half­ life (Disulfoton) 6.12 days (0.113/ d) Upper 90% confidence bound on the mean of "half­ lives" for the two aerobic soils tested in the laboratory. MRIDs 40042201, 41585101, 43800101 Aerobic Soil Half­ life 1 (Total Disulfoton Residues) 259.63 days (2.67E­ 03/ d) Upper 90% confidence bound on the mean of half­ lives for the two aerobic soils tested in the laboratory. MRIDs 40042201, 41585101, 43800101 Water Photolysis 3.87 days (pH = 5) (0.179/ d) MRID 40471102 Aerobic Aquatic Half­ life (Disulfoton) (Kbaws, Kbacs) 12.2 days (0.05682/ day) Estimated per EFED guidance Aerobic Aquatic Half­ life (Total Disulfoton Residues) (Kbaws, Kbacs) 259.63 days (2.67E­ 03/ d) Did not multiple half­ life by 2 per EFED guidance to account for uncertainty. Half­ lives greater than a year would show residue accumulation. Foliar Dissipation Rate 3.3 days (0.21/ d) MRID 41201801 1 Half­ lives for total residues were determined from the total residues at each sampling interval. Total disulfoton residues did follow first­ order kinetic decay (The slope (decay rate constant, k) of the transformed (natural log or ln) (ln C( t) = ln Co ­ kt, where Co is the initial concentration, C is concentration, and t is time) ). 11 A. Surface Water Drinking Water Assessment with Percent Crop Area and Index Reservoir. The estimated drinking water concentrations (EDWCs) were evaluated using the methodology outlined in EPA­ OPP draft Guidance for Use of the Index Reservoir and Percent Crop Area Factor in Drinking Water Exposure Assessments (USEPA, 2000). This generally results in the modification of the scenarios developed for farm ponds to scenarios for the index reservoirs. The purpose the Index Reservoir (IR) scenario and the Percent Crop Area (PCA) for use in estimating the exposure in drinking water derived from vulnerable surface water supplies. Since the passage of the Food Quality Protection Act (FQPA) in 1997, the Agency has been using the standard farm pond as an interim scenario for drinking water exposure and has been assuming that 100% of this small watershed is planted in a single crop. The Agency is now implementing the index reservoir to represent a watershed prone to generating high pesticide concentrations that is capable of supporting a drinking water facility in conjunction with the percent cropped area (PCA) which accounts for the fact that a watershed large enough to support a drinking water facility will not usually be planted completely to a single crop. These two steps are intended to improve the quality and accuracy of the drinking water exposure for pesticides obtained by models. Percent Crop Area (PCA): PCA is a generic watershed­ based adjustment factor that will be applied to pesticide concentrations estimated for the surface water component of the drinking water exposure assessment using PRZM/ EXAMS with the index reservoir scenario. The output generated by the linked PRZM/ EXAMS models is multiplied by the maximum percent of crop area (PCA) in any watershed (expressed as a decimal) generated for the crop or crops of interest. Currently, OPP has PCA adjustments for four major crops – corn, cotton, soybeans, and wheat. Two are appropriate for disulfoton, cotton and wheat. The concept of a factor to adjust the concentrations reported from modeling to account for land use was first proposed in a presentation to the SAP in December 1997 (Jones and Abel, 1997). This guidance results from a May 1999 presentation to the FIFRA Scientific Advisory Panel (SAP), Proposed Methods For Determining Watershed­ derived Percent Crop Areas And Considerations For Applying Crop Area Adjustments to Surface Water Screening Models, and the response and recommendations from the panel. A more thorough discussion of this method and comparisons of monitoring and modeling results for selected pesticide/ crop/ site combinations is located at: http:// www. epa. gov/ scipoly/ sap/ 1999/ may/ pca_ sap. pdf. The Agency will continue to develop PCAs for other major crops in the same manner as was described in the May 1999 SAP presentation. However, the Agency expects that it will use smaller watersheds for these calculations in the near future. For minor­ use crops, the SAP found that the use of PCAs produced less than satisfactory results and advised OPP to further investigate possible sources of error. Thus, for the near term, OPP is not be using PCAs in a crop­ specific manner for both major crops that do not yet have PCAs and minor­ use crops. 12 Instead it will use a default PCA that reflects the total agricultural land in an 8­ digit Hydrologic Unit Code (HUC). The PCA values used in this assessment are listed in Appendix VII. The OPP guidance document provides information on when and how to apply the PCA to model estimates, describes the methods used to derive the PCA, discusses some of the assumptions and limitations with the process, and spells out the next steps in expanding the PCA implementation beyond the initial crops. Instructions for using the index reservoir and PCA are provided below. Discussion on some of the assumptions and limitations for both the PCA and Index Reservoir are included in the Reporting section. One should note that there is an entry for `All Agricultural Land' in Appendix VII. This is a default value to use for crops for which no specific PCA is available. It represents the largest amount of land in agricultural production in any 8­ digit hydrologic unit code (HUC) watershed in the continental United States. The unadjusted EDWC (PRZM/ EXAMS output) is multiplied by the appropriate PCA for that crop to obtain the final estimated drinking water concentration (EDWC). Note that if Tier 2 modeling is done for an area other than the standard scenario, the PCA would still be applied, since it represents the maximum percent crop area for that particular crop. (As regional modeling efforts are expanded, regional PCAs could be developed in the future.) As an example, for a pesticide used only on cotton, the PRZM/ EXAMS estimated environmental concentrations would be multiplied by 0.20. This factor would be applied to the standard PRZM/ EXAMS scenario for cotton or any non­ standard cotton scenario until such time as regional PCAs are developed. When multiple crops occur in the watershed, the co­ occurrence of these crops needs to be considered (maximum of 0.87). The PCA approach assumes that the adjustment factor represents the maximum potential percentage of a watershed that could be planted to a crop (0.87). If, for example, a pesticide is only used on cotton, then the assumption that no more than 20% of the watershed (at the current HUC scale used) would be planted to the crop is likely to hold true. The Index Reservoir (IR): Barley, cotton, potatoes, and spring were considered because they represent significant uses, maximum application rates, and are grown in vulnerable regions of the United States. This excludes the Christmas tree use, for which there is not a adequate Tier II scenario. For the PRZM, the input files for each IR scenario are essentially the same as its farm pond scenario. Three parameters in the PRZM input file require modification, AFIELD, HL, and DRF (http:// www. epa. gov/ scipoly/ sap/ 1998/ index. htm). The Tier II modeling results (Table 1) from PRZM/ EXAMS fall within the range of parent disulfoton concentrations for surface water reported in a Virginia monitoring study (0.37 to 6.11 : g/ L) and NAWQA (0.010 to 0.060 : g/ L). The modeled parent disulfoton concentration estimates are generally greater than those seen in the monitoring data. The modeling results of the degradates correspond reasonably well with those measured at fish kill incident site, but were greater than the detections in the pilot reservoir study. The monitoring data for the disulfoton degradates is extremely limited. 13 Uncertainty surrounds these estimates because the sites selected for modeling represent sites thought to be representative of vulnerable sites. Additionally, the IR was generic (to each scenario) and data to fully understand of the fate of disulfoton and disulfoton residues is not available. Evidence suggests that the concentrations will not be as high as suggest by the modeled estimates. The PCA values have been estimated by OPP for spring wheat (0.56) and cotton (0.20). The default for value for all agricultural land of 0.87 was used for the barley, potatoes, and tobacco scenarios. Better estimates of the PCA for these crops would reduce the uncertainty associated with the estimated drinking water concentrations. B. Ground Water Assessment For this assessment, the maximum rate and number of disulfoton applications were used, while assuming average environmental properties (90 percent upper confidence bound on the mean aerobic soil half­ life of 6.12 days and an average Koc value of 551 mL/ g). The maximum parent disulfoton concentration predicted in ground water by the SCI­ GROW model (using the maximum rate 3 lb. a. i./ ac @ 1 applications ­ potatoes or 1 lb. ai./ ac @ 3 applications) was 0.02 : g/ L. The maximum total disulfoton residue concentration predicted in ground water by the SCI­ GROW model is 1.19 : g/ L (90 percent upper bound on mean half­ life of total residues is 259.6 days). It should be noted that all the detections of disulfoton residues in ground water in Wisconsin (range 4.0 to 100.0 : g/ L) and some detections in Virginia (range 0.04 ­2.87 : g/ L) exceeded the concentrations predicted by SCI­ GROW (0.02 : g/ L). Although SCI­ GROW, which is thought to be conservative (e. g., a vulnerable site), is based on a regression relationship between monitoring data (detected concentrations) and pesticide fate chemistry at vulnerable sites, SCI­ GROW does not account for preferential flow, point­ source contamination, pesticide spills, misuses, or pesticide storage sites. Many unknowns, data limitations, such as on­ site variability, are also present in the prospective ground­ water monitoring studies which were not included when developing SCI­ GROW. The difference between monitoring and modeling is discussed further in the next section. Disulfoton Monitoring Data Surface Water Monitoring: Virginia: The previously discussed study to evaluate the effectiveness of Best Management Practices (BMP) in a 3616­ acre watershed in the Nomini Creek Watershed, Westmoreland County, Virginia (Mostaghimi, 1989; Mostaghimi et al. 1998) also collected a limited number of runoff and surface water samples at two stations. For more discussion see Ground­ Water Section above, and Appendix 1. The results the surface water monitoring for disulfoton parent is presented in Table 6. 14 Table 6. Disulfoton detections in surface water samples collected in the Nomini Creek Watershed (Virginia), during 1986. Sample date Site number: Sample number Concentration ( : g/ L) 8/ 18/ 86 QN1: 1 (9: 13 am) 6.11 8/ 18/ 86 QN1: 2 (12: 25 pm) 0.37 9/ 28/ 86 QN2: (only 1 sample) 1.62 NAWQA: Disulfoton residues have been detected in surface water at a low frequency in the USGS NAWQA study. The percentage of detections with disulfoton concentrations >0.01 : g/ L for all samples, agricultural streams, urban streams were 0.27%, 0.20, and 0.61%, respectively. The corresponding maximum concentrations were 0.060, 0.035, and 0.037 : g/ L. Disulfoton has not been detected in ground water in the NAWQA study. Although pesticide usage data is collected for the different NAWQA study units, the studies are not targeted, specifically for disulfoton. STORET: About 50 percent of the well samples reported in STORET had low levels (< 1 : g/ L) of disulfoton residues. However, there were indications of some high concentrations (the other 50% were reported as <250 : g/ L), which may be a reflection of how the data were reported as the disulfoton concentrations in the monitoring were not always known. This is because the detection limit was extremely high or not specified, and/ or the limit of quantification was not stated or extremely high. Disulfoton concentrations were simply given as less than a value. Therefore, considerable uncertainty exists with respect to the STORET monitoring data. The STORET data was considered only from a "qualitative" standpoint. EFED considered in the assessment that while one does not know the concentration in the wells reported as disulfoton concentrations < 1 : g/ L , you know do it is not > than 1 : g/ L. Ground Water Monitoring: Monitoring Studies With No Disulfoton Residues Detections in Ground Water: The Pesticides in Ground Water Data Base (USEPA, 1992) summarizes the results of a number of groundwater monitoring studies conducted which included disulfoton (and rarely the disulfoton degradates D. sulfone and D. sulfoxide). Monitoring, with no detections (limits of detections ranged from 0.01 to 6.0 : g/ L), has occurred in the following states (number of wells): AL (10), CA (974), GA (76), HI (5), IN (161), ME (71), MS (120), MN (754), OK (1), OR (70), and TX (188). The range of detection limits, especially the high ones (e. g., 6 : g/ L) reduce the certainty of these data. One hundred twenty wells were analyzed in MS for disulfoton degradates sulfone and sulfoxide and 188 wells were analyzed in TX for sulfone. Limits of detection were 3.80 and 15 1.90 : g/ L for the sulfone and sulfoxide degrade, respectively, in MS. There were no degradates reported in these samples. North Carolina: The North Carolina Departments of Agriculture (NCDA) and Environment, Health, and Natural Resources (DEHNR) conducted a cooperative study under the direction of the North Carolina Pesticide Board (NCIWP, 1997). The purpose of the statewide study was to determine if the labeled uses of pesticide products were impacting the ground water resources in North Carolina. The study was conducted in two phases. In phase one, 55 wells in the DEHNR Ground Water Section's ambient monitoring network representing the major drinking water aquifers of the state were sampled at least twice and analyzed for selected pesticides. In phase two, 97 cooperator monitoring wells were installed and subsequently sampled at least twice in 36 counties across the North Carolina. Sites for the cooperator monitoring wells were chosen based on an evaluation of the vulnerability of ground water to risk of contamination from the use of pesticides. Monitoring wells were located adjacent to and down­ gradient from areas where pesticides were reported to have been applied (within 300 feet) during the previous five years. Wells were constructed so that the shallowest ground water could be collected for analysis. The objective of these criteria was to use a scientific method for determining monitoring well locations so that the results could be used as an early indication of the potential for problems associated with pesticides leaching to ground water. Disulfoton residues were monitored for in five North Carolina counties, Allegheny, Ash, Beaufort, Madison, and Robeson. Seven wells were located in Christmas Tree growing areas, one in wheat growing county, and two in tobacco areas. The study authors make the following statement, "Results cannot be interpreted as representing the quality of ground water near pesticide use areas statewide because the study methods targeted areas of highly vulnerable ground water". There were no detections of disulfoton, disulfoton sulfoxide, and disulfoton in the ground­ water monitoring study conducted in North Carolina. Efforts were made to place the wells in vulnerable areas where the pesticide use was known, so that the pesticide analyzed for would reflect the use history around the well. Limitations of the study include that sites were sampled only twice and the limits of detections were high (e. g., > 1.0 : g/ L) for some of disulfoton analytes. Uncertainties associated with the study include whether two samples from eight wells are adequate to represent the ground­ water concentrations of disulfoton residues, if DRASTIC correctly identified a site's vulnerability, and if the wells were placed down­ gradient of the use areas. The study used tools and information available at the time of the study to identify vulnerable locations for well placement. This included statewide agricultural data from the N. C. Agricultural Statistics which were used to identify crop growing areas, the USEPA DRASTIC method (Aller et al., 1987) was used to locate the most vulnerable locations in the target crop growing areas, and local county agents of the USDA Natural Resources Conservation Service 16 (NRCS) helped identify cooperators­ farmers for placement of wells. The Pesticide Study staff and county agents also met with the cooperators to obtain pesticide use information. Other studies have shown that DRASTIC is not as good a method to identify vulnerable areas as hoped. The study appeared to QA/ QC practices. Monitoring Studies With Disulfoton Detections in Ground Water: Two of the studies cited in the PGWDB (USEPA, 1992) report the detection of disulfoton residues in ground water. The disulfoton detections in ground water in occurred studies conducted by Virginia Polytechnic Institute and State University (VPI& SU, Mostaghimi, 1989; Mostaghimi et al. 1998) in Virginia where disulfoton concentrations ranged from 0.04 to 2.87 : g/ L and in a Wisconsin Department of Natural Resources study in Wisconsin (WDNR, after Barton, 1982) where concentrations ranged from 4.00 to 100.00 : g/ L. Of specific are the disulfoton concentrations of parent disulfoton reported in these studies (VA and WI) that exceeded the estimate of 0.02 : g/ L obtained from EFED's SCI­ GROW (ground­ water screening model) model. Virginia: A monitoring study was conducted to evaluate the effectiveness of Best Management Practices (BMP) in a 3616­ acre watershed in the Nomini Creek Watershed, Westmoreland County, Virginia. (A more detailed assessment of the final report of Nomini Creek Watershed BMP study was prepared earlier (11/ 20/ 01) in Appendix 1). Approximately half of the watershed is in agriculture and the other half is forested. The major focus of this study was surface­ water quality rather than ground­ water quality. However, in addition to the surfacewater monitoring, twelve wells were analyzed for pesticides, including disulfoton. Samples were initially taken in 1985 and 1986 from four household wells in the Nomini Creek Watershed (NCW). Water samples from these wells were analyzed for 24 pesticides. Detectable levels of (not specified) pesticides were found in all four wells at concentrations below the respective MCL. One of these four household wells consistently had higher pesticide levels than the other wells. The study authors suggested that this household well was not "sufficiently protected and was contaminated by surface runoff from adjacent land". Based upon these results of the four household wells sampled, eight pairs of groundwater monitoring wells (39 to 54 feet deep) were installed at eight sites in the NCW and sampled approximately monthly from June 1986 through June 1997. Information concerning farming practices in the watershed was obtained from farmer interviews and questionnaires. Monitoring consisted of two (2) runoff and surface water monitoring stations; seven rain gauges; one weather station; and eight (8) pairs of ground­ water monitoring wells. The ground water wells were located primarily in agricultural areas. These wells were drilled in pairs, 100 ­ 150 meters apart, with one in pair located hydraulically down­ gradient of the other. Approximately monthly samples were taken from each monitoring well and analyzed for a number of analytes including 22 pesticides. QA/ QC procedures were followed. The mean of all parent disulfoton detections is 0.39 : g/ L, the mean of the pre­ BMP is 0.52 : g/ L, and post­ BMP is 0.08 : g/ L (Table 7). The maximum detection was 2.87 : g/ L The final report is discussed in Appendix 1. 17 Table 7. Ground­ water parent disulfoton sampling results and detection statistics in the Nomini Creek Watershed (Mostaghimi, 1998). Pesticide Total Samples Detections 1 Detection 2 Frequency (percent) Concentration ( : g/ L) Max Mean SD Disulfoton 1010 10 1.0 2.87 0.39 0.32 Pre­ BMP 3 (5/ 86 ­ 10/ 88) 229 7 3.1 2.87 0.52 Post BMP 4 (11/ 89 ­ 9/ 96) 693 3 0.4 0.10 0.08 1 Number of samples with detectable levels of pesticide 2 (samples with detectable levels of pesticide * 100)/ total number of samples 3 Before agricultural Best Management Practice (BMP) implemented in watershed. 4 Following the implementation of BMP within the watershed. Wisconsin: Barton, 1982. In May and June 1982, the Wisconsin Department of Natural Resources (WDNR) sent twenty­ nine water samples from wells in the Central Sands area of Wisconsin to the EPA's Office of Pesticide Programs for pesticide residue analysis. Samples were taken from one municipal well, two or three community wells, and twenty­ five home wells; all of which were sources of drinking water. Of the 29 samples, 15 samples were reported as no detects whereas 14 samples were reported disulfoton detections. Disulfoton detections ranged from 4.00 to 100.00 : g/ L, with a mean (samples with detections) of 38.43 : g/ L and standard deviation of 31.56 : g/ L. No detection limit was specified for disulfoton, although detections as low as 1 : g/ L are reported for other pesticide residues (aldicarb, and aldicarb sulfone, dinoseb, sencor, linuron, carbofuran, and Lasso/ Bravo). Holden (1986) wrote that the WDNR sampling program was criticized for a number of reasons including that the quality assurance and quality control procedures (QA/ QC) were not always followed during some stages of sampling and analysis (Holden, 1986). Holden (1986) further indicates that "Harkin et al. (1984) noted in their WIS WRC report Pesticides in Groundwater beneath the Central Sand Plain of Wisconsin that some detections of pesticides in initial screening were false positives and were not supported by resampling and reanalysis by more sensitive analytical methods." Aldicarb and aldicarb sulfone were also found in this study and in follow up studies, while disulfoton was apparently not found in follow­ up sampling. Aldicarb is no longer registered for use in Wisconsin. The criticisms of the WDNR study must, however, be put in some sort of perspective. First, a study that did not follow QA/ QC criteria does not and should not automatically mean that 18 the data is bad or wrong, the detections may be correct (presence and wrong magnitude). Frequently "older" monitoring studies often had problems associated with them, such as QA/ QC problems, limited pesticide usage information, and no knowledge about the study area's hydrology. Frequently, studies with QA/ QC programs are poorly designed, so that the results may be meaningless. These data were considered in the water assessment, but were not included when deriving the disulfoton concentrations (EDWCs) for human health assessment. Pesticide residues not being found in follow­ up sampling may be the result of dissipation processes and should not be used to discount detections in earlier samples. The environmental fate properties and site hydrology must also be considered. Because ground water is a dynamic system, pesticides may be present at one sampling event and not at another. So when the sample is collected, in relationship to pesticide use and rainfall, is important. All that can be said is that residues were not found in follow­ up samples. It is unknown which samples were re­ analyzed with more sensitive methods. The disulfoton detections in the Central Sand Plain may have been the result of preferential flow and transport processes. Literature documents preferential flow in the Central Sand Plain. Thus, disulfoton residues may have by­ passed the soil matrix and gone directly to ground water which is possibly reflected in the "high" level of the detections. Although preferential flow is currently an ongoing area of research and much remains unknown, it is known that preferential flow is influenced by a number of factors, including rainfall amounts, intensity, and frequency. Disulfoton generally appears to be not very persistent under aerobic soil conditions and therefore may also not be very persistent in aquifers that are aerobic. Therefore it may have also been missed by utilizing a predetermined sampling schedule (e. g., monthly). Whereas a persistent chemical, such as aldicarb and aldicarb sulfone, will be found at greater frequencies and be less dependent upon timing of sampling. Disulfoton usage history before the detections and prior to the follow­ up sampling is not specified. Additional Monitoring Without Disulfoton Detections OPP's EFED contacted individuals in nearly all the states concerning whether organophosphate (OP) pesticides had been sampled for in their state as part of the cumulative OP assessment (http:// www. epa. gov/ pesticides/ cumulative/ pra­ op/ iii_ e_ 3­ f. pdf). The following presents the survey of states conducted by EFED for the cumulative OP assessment with respect to disulfoton, disulfoton sulfone, and disulfoton sulfoxide. Florida, did not include disulfoton or disulfoton degradates, but is included because the sulfone and sulfoxide degradates of the OP fenamiphos was included. EFED has not evaluate whether any of the monitoring studies noted below were also included in those reported in the PGWDB (USEPA, 1992). Florida Over 20,000 "determinations" were made for OPs in several Florida ground­ water monitoring programs. Only wells with detections are reported, both for fenamiphos sulfoxide. 19 This is a large dataset, and it will require more conversations with Florida to understand the full significance of these data. Continued monitoring in the Lake Ridge monitoring program includes fenamiphos and transformation products fenamiphos sulfoxide and sulfone. These have not been detected in quarterly sampling of monitoring wells in 11 to 33 wells over the last two years. Hawaii Robert Boesch of the Department of Agriculture described a drinking­ water study conducted this past March. In preparation for the OP risk assessment, Hawaii sampled 36 drinking­ water wells in areas where OPs are used on pineapples, or for urban use. These water supply wells, which have shown contamination for other organic chemicals, did not have detections (LOD 0.5 ppb) of the following OPs: acephate, azinphos methyl, chlorpyrifos, DDVP, demeton, diazinon, dimethoate, disulfoton, ethoprop, fenamiphos, malathion, methidation, methyl parathion, mevinphos, monocrotophos, naled and parathion. Kansas Theresa Hodges of the Kentucky Department of Health and Environment reports that of the OPs, only diazinon has been detected in their routine ambient surface water quality sampling network. While diazinon is not on the list of pesticides routinely included, it was added because it had been detected. Since 1995, 44 detections were found at 16 urban or golf course sites. The range of detections was from 0.19 to 1.5 micrograms/ liter. Dale Lambley of the Kansas Department of Agriculture sent information on their ground­ water monitoring of chemigation wells. The objective of the study "is to assess and monitor groundwater quality by obtaining water samples at selected chemigation sites located at agricultural irrigation wells." In sampling from 1987 to 2000, chlorpyrifos was detected three times at concentrations of 1.9, 3.5 and 4.2 ppb (LOD = 0.5 : g/ l). Dimethoate, disulfoton and methyl parathion were included in sampling, but were not detected above detection levels of 2.0, 0.5 and 1.0 : g/ l, respectively. The 100 samples taken annually are apportioned among five Groundwater Management Districts based on the number of registered chemigation sites in each. Highest priority is given to finding active chemigation sites. Ranking of wells has also been based on proximity to public water supplies (within 3 miles), depth to water, soil type, and whether chemigation misuse is suspected. Kentucky Peter Goodman reports that the following OPs are included in their ground­ water monitoring program: acephate, chlorpyrifos, diazinon, disulfoton, ethoprop, malathion, methyl parathion and 20 terbufos. Each was included in more than 1300 analyses from over 300 wells, but only diazinon, chlorpyrifos and malathion were detected. Maryland Rob Hofstedter of the Maryland Department of Agriculture reports that their agency has a current ground­ water study that includes diazinon. Results of this study are not yet available. He referred me to the Maryland Geological Survey for information on previous surface­ water studies which included malathion. David Bolton of the Maryland Geological Survey provided summary tables from the MGS Report of Investigations number 66, "Ground­ Water Quality in the Piedmont Region of Baltimore County, Maryland." Analysis in this rural region included 12 OPs, 10 of which are still registered. Disulfoton was not detected in ground water. Results of the monitoring are as follows, which concentrations in : g/ l. Pesticide # samples MRL 1 >/= MRL <MRL Maximum Conc. Disulfoton 112 0.017 0 0 1 MRL = Minimum Reporting Limit Michigan Mark Breithart of the MDEQ Drinking Water Division examined their database, and found that analysis was done for the following OPs in Michigan drinking water: azinphos methyl, chlorpyrifos, diazinon, dimethoate, disulfoton, fenamiphos, malathion, and methyl parathion None of these were detected in 49 analyses of public water supplies. Of the 421 analyses from private water supplies, only dimethoate was detected. This single detection of 2 micrograms/ liter occurred at an aerial spray service, and therefore it is not clear if it was the result of a point source. Nebraska Nebraska maintains the "Quality­ Assessed Agricultural Contaminant Database for Nebraska Ground Water," which was created from ground water quality data submitted by many organizations." There were no disulfoton detections in 185 analyses. The following OPs are included in the database: chlorpyrifos, diazinon, ethion, malathion, methyl parathion, phorate, and terbufos. The levels of detection are generally below 1 ppb. Mr. John Lund, supervisor in the Surface Water Unit of the Nebraska Department of Environmental Quality, indicated that OPs have not been included in the State's surface­ water monitoring. 21 North Carolina Dr. Henry Wade described the "Interagency Study of the Impact of Pesticide Use on Ground Water in North Carolina," which took place between 1991 and 1995. Sampling of mostly shallow monitoring wells was performed based on information by farmers on which pesticides they used within 300 feet of the wells. By the end of the study, more than 240 pesticides were included as analytes. Sixteen OPs were included in the analysis, but none were detected. The number of wells sampled for each OP is shown below: acephate (23 wells), azinphos­ methyl (7), chlorpyrifos (25), diazinon (8), dimethoate (5), disulfoton (12), ethoprop (6), fenamiphos (4), fonofos (1), malathion (9), mevinphos (1), parathion (5), phorate (3), phosmet (2), terbufos (13) and trichlorfon (2). Other pesticides were detected in these wells, especially herbicides. The main focus of the study was herbicides which the EPA had identified as "potential leachers." West Virginia Doug Hudson of the WV Department of Agriculture says that West Virginia DoA does intermittent ground water sampling, including an OP screen. He could recall only a single detection of diazinon, which they could not confirm. Other OP detections in ground water were in response to improper termiticide use. Chad Board of the DEP sent a spreadsheet with analytical results which included the following OPs: chloropyrifos, diazinon, disulfoton, ethoprop, malathion, phorate, and terbufos. Each were sampled in 12 wells, but not detected. The detection limits ranged from 0.005 to 0.027 ppb. Wisconsin Bill Phelps, of the Wisconsin Department of Natural Resources Bureau of Drinking & Groundwater provided a summary of monitoring Wisconsin has done in public and private water supply wells and information on monitoring from their GEMS database performed at regulated/ investigated sites. The detections of disulfoton occurred at a pesticide formulation plant ­ thus this would be a point source rather than non­ point source normal use. Analyte # Water Supply Wells # Detects in Water Supply Wells #GEMS wells # GEMS wells with detections Maximum concentration detected (ug/ l) disulfoton 0 190 9 240 Wyoming 22 Jim Bigelow of the Wyoming Department of Agriculture described the generic Pesticide Management Plan ground­ water program, which includes a network of 178 wells. A total of 54 active ingredients are included as analytes, including eight active OPs: azinphos­ methyl, chlorpyrifos, diazinon, disulfoton, malathion, methyl parathion, phorate and terbufos. Ms. Miller indicated that there have been detections of pesticides in 117 of 178 wells. The Agency will investigate further details of this monitoring program. Limitations of Monitoring Data The interpretation of the monitoring data is limited by the lack of correlation between sampling dates and the use patterns of the pesticide within the study's drainage basin. Additionally, the sample locations were not associated with actual drinking water intakes for surface water nor were the monitored wells associated with known ground water drinking water sources. Also, due to many different analytical detection limits, no specified detection limits, or extremely high detection limits, a detailed interpretation of the monitoring data is not always possible. Limitations for the monitoring studies include the use of different limits of detection between studies, lack of information concerning disulfoton use around sampling sites, and lack of data concerning the hydro geology of the study sites. The spatial and temporal relationship between disulfoton use, rainfall/ runoff events and the location and time of sampling cannot often be adequately determined. Thus, it is not always possible to judge the significance of the level or the lack of detections. Although no assessment can be made for degradates due to lack of monitoring data, limited data suggests that the degradates are more persistent (> 200 days) than disulfoton, suggesting their presence in water for a longer period of time than the parent. The degradates also appear to be more mobile than the parent compound. vii. Limitations of this Modeling Analysis There are number of factors which limit the accuracy and precision of this modeling analysis including the selection of the high­ end exposure scenarios and maximum number of applications and rates, the quality of the data, the ability of the model to represent the real world, and the number of years that were modeled. There are additional limitations on the use of these numbers as an estimate of drinking water exposure. Individual degradation/ metabolism products were also not considered due to lack of data. Another major uncertainty in the current EXAMS simulations is that the aquatic degradation rate used an estimated rate due to lack of data. Direct aquatic photolysis was also included. The total disulfoton residue decline rate was estimated from data, but Kocs and hydrolysis rates for D. sulfoxide and D. sulfone were not known and assumed to be equal to those of parent disulfoton. These limitations influence the estimates of 23 pesticides transported off the field (loading files) to the reservoir, plus the degradation once in the reservoir. Spray drift is determined by method of pesticide application, and is assumed to be 0% percent when applied as broadcast (granular) or in­ furrow, and 6.4% ground and 16.4% aerial spray for the Index Reservoir scenario (Jones et al., 2000). The Tier II scenarios are also ones that are likely to produce high concentrations in aquatic environments. The scenarios were intended to represent sites that actually exist and are likely to be treated with a pesticide. These sites should be vulnerable enough to provide a conservative estimates of the EDWC, but not so vulnerable that the model cannot properly simulate the fate and transport processes at the site. The EDWCs in this analysis are accurate only to the extent that the sites represent the hypothetical high exposure sites. The quality of the analysis is also directly related to the quality of the chemical and fate parameters available for disulfoton. Acceptable data are available, but rather limited (minimal) or not available for the degradates. Data were not available for degradates and the aquatic aerobic metabolism rate was not known, but estimated. Degradates with greater persistence and greater mobility would be expected to have a higher likelihood of leaching to ground water, with greater concentrations in surface water. The measured aerobic soil metabolism data is limited, but has sufficient sample size to establish an upper 90% confidence bound on the mean of halflives for the three aerobic soils tested in the laboratory (and submitted to EFED) and reported in the EFED One­ liner Database (MRIDs 40042201, 41585101, 43800101). The use of the 90% upper bound value may be sufficient to capture the probable estimated environmental concentration when limited data are available. PRZM assumes pesticide decline follows firstorder kinetics. As discussed in the aerobic soil metabolism section of the disulfoton RED, disulfoton doesn't entirely follow first­ order kinetics. The models themselves represent a limitation on the analysis quality. These models were not specifically developed to estimate environmental exposure in drinking water so they may have limitations in their ability to estimate drinking water concentrations. Another limitation is the lack of field data to validate the predicted pesticide run­ off. Although, several of the algorithms (volume of run­ off water, eroded sediment mass) are somewhat validated and understood, the estimates of pesticide transport by PRZM3 has not yet been fully validated. Other limitations of PRZM are the inability to handle within site variation (spatial variability), crop growth, and the overly simple water balance. Another limitation is that 20 to 40 years of weather data were available for the analysis. Consequently there is a 1 in 20, 27, 36, or 40 chance that the true 10% exceedence EDWCs are larger than the maximum EDWC in the analysis. If the number of years of weather data were increased, it would increase the level of confidence that the estimated value for the 10% exceedence EDWC was close to the true value. EXAMS is limited because it is a steady­ state model and cannot accurately characterize the dynamic nature of water flow. A model with dynamic hydrology would more accurately reflect concentration changes due pond overflow and evaporation. Thus, the estimates derived 24 from the current model simulates a pond having no­ outlets, flowing water, or turnover. Another major limitation in the current EXAMS simulations is that the aquatic (microbial) and abiotic degradation pathways were adequately considered. Disulfoton and the sulfone and sulfoxide degradates were considered as total disulfoton residues. The binding potentials of the degradates were not known (they were not considered individually), but were assumed to be the same as parent disulfoton. Citations: Barrett, M. R. 1999. Updated Documentation on the SCI­ GROW Method to Determine Screening Concentration Estimates for Drinking Water Derived from Ground Water Sources. Memorandum From: M. R. Barrett To: J. Merenda. Environmental Fate and Effects Division, Office of Pesticide Programs, U. S. Environmental Protection Agency, Arlington, VA. Barton, A. 1982. Note to Ed Johnson dated 12/ 10/ 82 describing joint effort between EPA/ OPP and Wisconsin Department of Natural Resources to monitor pesticides in ground water per communication with the Wisconsin Department of Natural Resources. 1982. Pesticide Monitoring in Wisconsin Ground Water in the Central Sands Area. Madison, WI Harken, J. M., F. A. Jones, R. Fathulla, E. K. Dzanton, E. J. O'Neill, D. G. Kroll, and G. Chesters. 1984. Pesticides in Groundwater beneath the Central Sand Plain of Wisconsin. Univ. of Wisc. Resources Center Technical Report WIS WRC 84­ 01. Holden, P. W. 1986. Pesticide and Groundwater Quality Issues and Problems in Four States. National Academy Press. Washington, D. C. Jones, R. D., J. Breithaupt, J. Carleton, L. Labelo, J. Lin, R. Matzner, R. Parker, W. Effland, N. Thurman, and I. Kennedy. 2000. Guidance for Use of the Index Reservoir and Percent Crop Area Factor in Drinking Water Assessments. Draft 3/ 21/ 2000. Environmental Fate and Effects Division, Office of Pesticide Programs, U. S. Environmental Protection Agency, Arlington, VA. Mostaghimi, S. et al. 1989. Watershed/ Water quality monitoring for evaluating BMP effectiveness ­ Nomini Creek Watershed. Report N­ P1­ 8811. Agricul. Engineer. Dept. Virginia Tech. Mostaghimi, S., S. Shukla, and P. W. McClellan. 1998. BMP Impacts on Nitrate and Pesticide Transport to Groundwater in the Nomini Creek Watershed. Final Report No. NC­ 0298 Biological Systems Engineering Department, Virginia Polytechnic Institute and State University, Blacksburg, VA NCIWP, 1997. The Interagency Study of the Impact of Pesticide Use on Ground Water in North Carolina. Prepared for North Carolina Pesticide Board by The Interagency Work Group. March 4, 1997. North Carolina Department of Agriculture, Raleigh, NC. 25 PRZM/ EXAMS Modeling, dated 4/ 13/ 99) from Water Quality Technology Team, Environmental Fate and Effects Division, Office of Pesticide Programs, USEPA. Arlington, VA. USEPA., 2000. DP Barcode 267486 EPA Review of NCIWP, 1997. The Interagency Study of the Impact of Pesticide Use on Ground Water in North Carolina. Prepared for North Carolina Pesticide Board by The Interagency Work Group. March 4, 1997. North Carolina Department of Agriculture, Raleigh, NC and its relevance to the disulfoton. References­ Personal Communications Kevin Costello, EFED (http:// www. epa. gov/ pesticides/ cumulative/ pra­ op/ iii_ e_ 3­ f. pdf). Note: All states contacted are listed below. Only the states which monitored for disulfoton (except Florida) are include in this document. Monitoring contacts Tony Cofer, Pesticide Administrator of the Alabama Department of Agriculture and Industry Groundwater Protection Section Dr. Enid Probst , Alabama Department of Environmental Management Rose Lombardi , Alaska Department of Environmental Conservation Pesticide Program Charles Armstrong, Assistant Director, Arkansas State Plant Board Dr. Robert Matzner, California Department of Pesticide Regulation Frank Spurlock, California Department of Pesticide Regulation Brad Austin, Water Quality Control Division, Colorado Department of Public Health and Environment Judith Singer, Connecticut Department of Environmental Protection Pesticide Management Division Scott Blaier , Hydrologist, Delaware Department of Agriculture Keith Parmer, Florida Department of Agriculture and Consumer Services Doug Jones, Georgia Department of Agriculture Robert Boesch, Hawaii Department of Agriculture Pesticides Branch Gary Bahr, Idaho Dept of Agriculture Division of Agricultural Technology 26 Dave McMillan, Illinois Environmental Protection Agency, Bureau of Water, Ground Water Section Ryan McDuffee , Environmental Scientist, Indiana Department of Environmental Management Al Lao, Indiana Department of Environmental Management Mary Skopec, Acting Section Supervisor, Iowa Department of Natural Resources Water Monitoring Section Theresa Hodges, Kansas Department of Health and Environment Dale Lambley, Special Environmental Assistant to the Secretary, Kansas Department of Agriculture Peter Goodman, Manager, Ground Water Branch, Division of Water, Kentucky Department of Environmental Protection Karen Irion, Louisiana Julie Chizmas, Senior Water Quality Specialist, Maine Department of Agriculture Rob Hofstedter, Maryland Department of Agriculture David Bolton, Maryland Geological Survey Kenneth Pelotiere, Massachusetts Department of Environmental Protection Source Water Assessment Program Dennis Bush, Surface Water Quality Division, Michigan Department of Environmental Quality Mark Breithart, Drinking Water Division, Michigan Department of Environmental Quality Daniel Helwig, Minnesota Pollution Control Agency Mark Zabel, Minnesota Department of Agriculture Rusty Crowe, Mississippi Department of Agriculture and Commerce Bureau of Plant Industry Shedd Landreth, Mississippi Department of Environmental Quality Paul Andre, Program Coordinator, Department of Agriculture Plant Industries Division 27 Terry Timmons, Missouri Department of Natural Resources John Ford, Missouri Department of Natural Resources Donna Rise, Montana Department of Agriculture, Agricultural Sciences Division, Technical Services Bureau John Lund, Supervisor, Surface Water Unit, Nebraska Department of Environmental Quality Craig Romary, Nebraska Department of Agriculture, Bureau of Plant Industry Scott Cichowlaz, Nevada Depart (of Ag?) Pat Bickford, New Hampshire Department of Environmental Services Dr. Roy Meyer, Pesticide Monitoring and Evaluation, New Jersey Department of Environmental Protection Doug Henson, New Mexico Department of Agriculture, Bureau of Pest Management. Jeff Myers, New York Department of Environmental Conservation Bureau of Technical Support Dr. Henry Wade, Environmental Programs Manager, North Carolina Department of Agriculture and Consumer Services William Schuh, North Dakota State Water Commission Norene Bartelson, North Dakota Department of Health Todd Kelleher, Ohio Environmental Protection Agency Department of Drinking and Ground Waters Julie Letterhos, Ohio Environmental Protection Agency Department of Drinking and Ground Waters Gail Hess, Ohio Environmental Protection Agency Don Molnar, Oklahoma Department of Agriculture, Plant Industry and Consumer Services Division John Pari, Pennsylvania Department of Agriculture, Bureau of Plant Industry Eugene Pepper, Rhode Island Department of Environmental Management, Division of Agriculture and Resource Marketing 28 Jerry Moore, South Carolina Pesticide Regulation Board, Clemson University Peter Stone, South Carolina Department of Health and Environmental Control Kathy Stecker, South Carolina Department of Health and Environmental Control Stan Pence, Senior Hydrologist, South Dakota Geological Survey Brad Berven, South Dakota Department of Agriculture Pesticide Program Ken Nafe, Tennessee Department of Agriculture Dr. Ambrose Charles, Texas Department of Agriculture Mark Quilter, Utah Department of Agriculture and Food Arne Hulquist, Utah Department of Environmental Quality Cary Giguere, Vermont Department of Agriculture, Food and Markets Marvin Lawson, Virginia Department of Agriculture and Consumer Services Daniel Schweitzer, Virginia Department of Agriculture and Consumer Services Doug Hudson, West Virginia Department of Agriculture Chad Board, West Virginia Department of Environmental Protection William Phelps, Wisconsin Department of Natural Resources Bureau of Drinking & Groundwater Jim Bigelow, Wyoming Department of Agriculture Cheryl Eddy Miller, United States Geological Survey, Wyoming Robert Sneed, United States Army Corps of Engineers 29 APPENDIX 1. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES TO: Christina Scheltema Betty Shackleford Michael Goodis Special Review and Reregistration Division (7508C) FROM: James Wolf ERB3 Environmental Fate and Effects Division (7507C) 30 DATE: November 20, 2001 RE: Disulfoton residues in ground water found in the Virginia BMP Study: BMP Impacts on Nitrate and Pesticide Transport to Groundwater in the Nomini Creek Watershed. Final Report No. NC­ 0298 S. Mostaghimi, S. Shukla, and P. W. McClellan. 1998. Biological Systems Engineering Department Virginia Polytechnic Institute and State University Blacksburg, VA # The ground water monitoring component was started in 1986 and ended in June, 1997. # Nomini Creek Watershed is located in Westmoreland County, Va. The 1463 ha watershed has typical Coastal Plain land use 49% cropland, 47% woodland, and 4% used for homestead and roads (different reports has slightly different breakdown, but have the same major uses). Average annual precipitation is 102 cm, with most of the rainfall occurring between April and September. Most ground water recharge occurs in late Fall or early spring. # Nomini Creek Watershed is located in the Coastal Plain Physiographic providence. Soils, geology and topography are similar to the of the unglaciated Atlantic Coastal Plain. Soils are mostly Ultisols. The major soil series are Suffolk and Rumford. These soils cover 91 percent of the area and have similar physical properties. Soil Taxonomy Sulfolk Coarse­ loamy, siliceous, thermic Typic Hapudults Rumford Coarse­ loamy, siliceous, thermic Typic Hapudults The Coastal Plain has been identified as a vulnerable area to ground water contamination. Other vulnerable regions have also been identified. The soils could also be used to identify possible problem areas. (Can't be done by tomorrow). These are vulnerable soil for leaching. # Agriculture is primarily row crops. Major crops are corn, soybeans, and small grains (wheat and barley). Typical rotation is conventionally­ tilled corn, followed by small grains with no­ till soybeans planted in the small grain residues. Occasionally, full season, conventionally­ tilled soybeans is also grown. USDA Ag Statistics do not report 31 tobacco production for Westmoreland County. Potatoes are reported to be produced, but production appears to be declining. # Study Objective to study the quality of surface and ground water as influenced by the agricultural practices in the watershed. # Monitoring consisted of two (2) runoff and surface water monitoring stations; seven rain gauges; one weather station; and eight (8) ground­ water monitoring wells (GN1 to GN8). The ground water wells were located primarily in agricultural areas. These wells were drilled in pairs, 100 ­ 150 meters apart, with one in pair located hydraulically downgradient of the other. Characteristic (m) Value Well GN1 GN2 GN3 GN4 GN5 GN6 GN7 GN8 Well depth 13.7 12.8 15.2 13.7 16.5 12.0 15.8 11.9 GW depth Mean 10.3 9. 6 13.1 9. 4 12.9 8. 2 13.3 8. 6 " Max. 12.0 10.8 14.0 12.7 13.9 9. 1 14.4 9. 6 " Min 8. 5 7.1 11.5 7. 0 11.3 7. 0 11.8 7. 4 # Approximately monthly samples were taken from each monitoring well and analyzed for a number of analytes including 22 pesticides. QA/ QC procedures were followed. # Herbicide and insecticide application information in the watershed were obtained from farmer surveys. The rate and time of herbicide application was dependent on the crop rotation adopted by the farmer. Corn is usually planted between late April and early May. Post­ emergence sprays applications occur in early July. The timing and application rates of insecticides, applied individually or in combination, in the watershed depending on the type and extent of the insect problem observed. Note: the label does allow for fall application to wheat. Perhaps fall application and greater fall recharge resulted in the observed concentration (2.87 : g/ L). Possible mitigation option? # Disulfoton sampling results and detection statistics in the Nomini Creek Watershed (Table 15, after Mostaghimi, 1998). These are disulfoton parent. Pesticide Total Samples Detections 1 Detection 2 Frequency (percent) Concentration ( : g/ L) Max Mean SD Disulfoton 1010 10 1.0 2.87 0.39 0.32 32 Pre­ BMP 3 (5/ 86 ­ 10/ 88) 229 7 3.1 2.87 0.52 Post BMP 4 (11/ 89 ­ 9/ 96) 693 3 0.4 0.10 0.08 1 Number of samples with detectable levels of pesticide 2 (samples with detectable levels of pesticide * 100)/ total number of samples 3 Before agricultural Best Management Practice (BMP) implemented in watershed. 4 Following the implementation of BMP within the watershed. Note: I only had (raw) data through 1990. Thus, I only had 6 of the 10 detections, mean was 0.57 : g/ L, which is only slightly greater than the mean with 7 samples (pre­ BMP). Discussion and recommendation: The following table was included in Feb. 7, 2000 Additional Clarification of Disulfoton GroundWater Monitoring Data Assessment. In a recent discussion about a "chronic" exposure for ground water the following suggestions was put forth (mean = 1.49 : g/ L = (2.87 +0.1)/ 2 for well site GN3. Considering there are many "monthly samples, with most being less than the detection limit, a lower mean is probably justified (disulfoton parent only). The mean of all the detections is 0.39 : g/ L, the mean of the pre­ BMP is 0.52 : g/ L, and post­ BMP is 0.08 : g/ L. Without specifically estimating a concentration, I think that as far as parent disulfoton goes, the average concentration would be expected to be considerably less than the DWLOC of 1.2(?). Summary of Disulfoton Detections in ground water from the eight ground­ water monitoring wells in Nomini Creek Watershed (Virginia), during 1986 and 1987. Sampling Date Well­ Site Number Concentration ( : g/ L) 11/ 5/ 86 GN3 2.87 11/ 5/ 86 GN6 0.04 3/ 13/ 87 GN4 0.10 8/ 20/ 87 GN1 0.13 8/ 20/ 87 GN2 0.16 8/ 20/ 87 GN3 0.10

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Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES PC Code: 032501 CHEMICAL: Disulfoton DP Barcode: D280670A March 7, 2002 MEMORANDUM TO: Betty Shackleford, CRM Christina Scheltema, PM Team Reviewer Michael Goodis Reregistration Branch 3 Special Review and Reregistration Division (7508W) FROM: James K. Wolf, Ph. D., Soil Scientist Environmental Risk Branch 3 THRU: Kevin J. Costello, Acting Branch Chief Environmental Risk Branch 3 Environmental Fate and Effects Division (7507C) SUBJECT: Correction to the Disulfoton: Summary of Estimated Drinking Water Concentrations (EDWCs) use in the Human Health Risk Assessment memo DP Barcode: D280670, date February 25, 2002. Footnote number 2 for Table 1 (page 2) is incorrect. It should be Barley with 1.0 lb ai/ A application has an EDWC that is (1.00/ 0.83) larger than the 0.83 lb ai/ A application. The difference between the to the two granular, soil applied barley estimates the difference in application rate (0.83 lb ai/ A compared to 1.0 lb ai/ A). Both used the same PCA value of 0.87. The incorrect footnote is as follows: Barley with 1.0 lb ai/ A application has an EDWC that is (1.0/ 0.87) larger than the 0.87 lb ai/ A application.

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Supporting & Related Material

1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Memorandum SUBJECT: Asparagus Benefits Assessment for Disulfoton FROM: Nikhil Mallampalli, Ph. D, Entomologist Herbicide and Insecticide Branch Colwell Cook, Ph. D, Entomologist Herbicide and Insecticide Branch Anthony Gilbert, Economist Economic Analysis Branch Biological and Economic Analysis Division (7503C) THROUGH: David Brassard, Ph. D., Senior Scientist Arnet Jones, Ph. D., Branch Chief Herbicide and Insecticide Branch Biological and Economic Analysis Division (7503C) TO: Christina Scheltema, Chemical Review Manager Betty Shackleford, Branch Chief Reregistration Branch 3 Special Review and Reregistration Division (7508C) PRP review date: September 5, 2001 Summary of Analysis Disulfoton is a critical pest management tool for asparagus growers in the primary production regions of the country. These regions lie in the Pacific northwest and California, and face large economic losses if populations of the European asparagus aphid are not rigorously and immediately controlled. Management of this insect pest is the primary reason for disulfoton use in this crop. Human health risk modeling suggests that the liquid form of disulfoton may pose risks to mixers, loaders, and applicators. However, all the disulfoton used in the U. S. asparagus crop is applied in liquid form, either aerially or by ground spray rigs. Thus, eliminating these methods of application is likely to result in significant negative impacts on asparagus production in the western U. S. The following analysis provides an overview of U. S. asparagus production, the role of disulfoton in asparagus production, a description of 2 available alternatives to disulfoton, and estimates of the impacts of eliminating aerial application and/ or the liquid forms of disulfoton in this crop. Overview Disulfoton is an organophosphate insecticide used on a wide variety of crops in part because it not only has contact toxicity but is also taken up by plant root systems and remains active against target insects for a relatively long time. HED risk modeling indicates that the liquid form of this chemical may pose hazards to mixer/ loaders and applicators (calculated MOE = 1­ 35) in asparagus. Therefore, SRRD has asked BEAD to investigate the importance of liquid disulfoton in U. S. asparagus production and the impacts created by restrictions on using the liquid form of this chemical. Re­ entry and pre­ harvest intervals are not being considered for regulatory action at this time. Asparagus, Asparagus officinalis, is a perennial row crop grown primarily in Washington and California, which together account for about 83% of U. S. production of this vegetable. Michigan accounts for approximately 13%, while the rest of the crop is grown in Arizona, Idaho, Illinois, Maryland, Minnesota, New Jersey, and Oregon (7) . Asparagus requires well­ drained, heavier soil with a relatively alkaline pH, and does best in climates where periods of either cold or drought regularly occur. These periods stimulate dormancy in the plants, and this in turn subsequently produces more vigorous vegetative growth of the plants, and thus higher yields. These conditions are best provided in the midwestern and northwestern parts of the U. S. A total of approximately 76,000 acres of asparagus were grown in the U. S. in 1999 (7) . While asparagus can be planted either with seeds, transplants, or crowns, the most common method is to establish fields is to plant one­ year old crowns. Crops are harvested no earlier than the second year after planting, so as to allow plants to undergo more vigorous growth. Harvesting of asparagus spears generally begins in mid­ January in the western U. S. and in early spring in the mid­ west and east coast areas, and continues through June. Virtually all harvesting is done by hand, on a repetitive basis, every one to five days during the early part of each growing season. This harvesting activity lasts one to two months, depending on the size and productivity of fields. After harvest, remaining spears are allowed to grow out into "ferns" (vegetative growth), during which little to no human presence is required in fields (1, 6) . Pest insect biology In asparagus, disulfoton is used primarily to control the European asparagus aphid, Brachycorynella ( = Brachycolus) asparagi, an insect specialized to feed only on this plant. B. asparagi was accidentally introduced from Europe in the early 1920s and is a serious pest of this crop in Washington, Oregon and California (1, 6) . It is brought into fields primarily via infested crown brought in from nurseries. Once in fields, aphids overwinter as eggs in old fern debris and cracks in the soil. All life stages occur on edible varieties of asparagus. Eggs hatch in the spring and nymphs crawl onto asparagus spears as they emerge from the soil. During most of the crop's growing season, aphids exist as nymphs, feeding and reproducing asexually. Aphid populations tend to build up under conditions of low rainfall or humidity. Major damage to plants occurs from a toxin injected by aphids during feeding. This toxin causes bushy, stunted, and bluish­ green growth. This in turn reduces the number of viable spears, due to dessication of the developing crowns. The toxin itself can also cause a delay in bud break and a profusion of small, less valuable spears (1, 6) . Even low populations of this aphid can cause total losses in an asparagus field, and growers often have no choice but to plow out the field and plant again (1, 4, 5) . Other aphid species, including the green peach aphid, and the bean, melon, and potato aphids, can also become problems on asparagus if left uncontrolled, but disulfoton use is thought to keep these pests rare (1, 3) . 3 Role of disulfoton in asparagus production During 1987­ 1998, a weighted average of 37,000 lb of disulfoton (active ingredient) were applied on asparagus nationwide; of this 96 % was used in California and Washington. The granular form of disulfoton is currently not registered for use on asparagus, (10) so all of these applications may reasonably be considered to be of the liquid form. Virtually all of this use was targeted against the asparagus aphid (1, 3, 4) . In California, Washington, and Oregon, disulfoton is applied using both ground­ boom or aerial methods. However, in all these regions, aerial applications are by far the more common. In 1999, 65 % of applications in California were aerial (2) . In California, closed mixing/ loading systems are required, but this is not the case in other states where disulfoton is registered for use on asparagus. In Washington and Oregon, an estimated 98 % of applications are aerial (3) . As a result, most of the disulfoton use in these primary asparagus producing areas is in the liquid form. The chemical is applied 1­ 2 times per year, almost always during the "fern" stage, when virtually no human presence in fields is required. Aerial application is dictated by the mat­ like growth of asparagus in the fern stage, which must be optimized to ensure good harvests the following season, and by the need to keep the crop well irrigated, which makes the soil wet and unstable. These factors often make the use of ground application equipment impossible, due to the difficulty involved in moving it about and the risk of significantly damaging ferns (3, 4) . Asparagus farm sizes tend to be larger in California as compared to other regions of the western U. S. production areas. In 1997, 48 % of asparagus farms in California had 100 acres or more of the crop; on average, these farms had 431 acres grown. Overall average farm size was 219 acres (8) . In Washington, no farms are greater than 300 acres; average size was 62 acres ( 9) . The maximum area treated in a day by an aerial applicator has been estimated to be about 75 to 150 acres in Washington, and 150 to 200 acres in California (3, 4) . These estimates were based (by the crop experts contacted) on discussions with aerial applicators in their respective states. This is partly a result of the fact that, even on larger farms, asparagus fields are interspersed with other crops, and applicators do not typically treat all the acreage of a given grower at any one time (3, 4) . Chemical alternatives For aphid control in asparagus, chlorpyrifos is the only currently registered chemical control alternative available in California. It is also available in Washington, and Oregon, where dimethoate is also an option in this context. Both these insecticides have significant drawbacks in this cropping system, however. Chlorpyrifos is not as effective as disulfoton in eliminating asparagus aphids from fields due to a short residual effect, and may cause outbreaks of other aphid species (1, 3) . Dimethoate also has a very short residual effect (1 day) and thus is also not as good as disulfoton (3) . Biological control agents such as ladybeetles and parasitic wasps occur, but cannot usually keep up with aphid infestations in the western growing regions (3, 4) . Impact of restricting disulfoton use in asparagus Curtailing aerial or liquid application of disulfoton will be effectively equivalent to eliminating this pesticide in asparagus, since ground application is so difficult and the granular form is not an option 4 for control of the target pest. Given the damage inflicted by the asparagus aphid, this can be expected to result in substantial economic losses to growers in Washington and California. Yearly per acre economic losses in Washington could exceed $700 if disulfoton were eliminated and growers were forced to rely on the other available chemical alternatives (chlorpyrifos and dimethoate). This would translate into aggregate losses to asparagus growers of about $273,000 per year. In California, per acre economic losses could exceed $1000 per season with an aggregate loss to growers of approximately $166,000 per year. This analysis corroborates the results of an earlier study, conducted by Washington State University in 1997. It estimated aggregate losses to the asparagus industry in these states of about $38,000,000 per year, about 40% of gross farm­ level (preprocessing level) revenue (1) . That study was based on chlorpyrifos and malathion as the chemical alternatives available. The authors estimated that this would end west coast asparagus production in four years at most. Sources and References 1. Eskelson, S., A. Schreiber, S. E. Crawford, and R. J. Folwell. 1997. Biological and Economic Assessment of the Impact of Pesticide Use on Asparagus. Washington State University Publication No. MISCO193. 2. California Dept of Pesticide Regulation data, courtesy of Linda Herbst, University of California, Davis. 3. Dr. Alan Schreiber, Agriculture Development Group, Pasco, WA. 4. Dr. Robert Mullen, University of California Cooperative Extension Service, Stockton, CA. 5. Ms. Cherie Watte, California Asparagus Commission, Stockton, CA. 6. USDA Crop Profile for Asparagus in California, Feb. 2000. 7. USDA/ NASS Agricultural Statistics 2000. 8. USDA/ NASS Census of Agriculture, California State and County Data. 1997. Vol. 1, part 5. 9. USDA/ NASS Census of Agriculture, Washington State and County Data. 1997. Vol. 1, part 47. 10. Crop Data Management Systems Pesticide database, http:// www. cdms. net/.

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EPA-HQ-OPP-2002-0055-0019

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Memorandum SUBJECT: Benefits of Disulfoton on Selected Vegetable Crops and Cotton FROM: Colwell Cook, Entomologist Herbicide and Insecticide Branch Biological and Economic Analysis Division THROUGH: David Brassard, Senior Scientist Jonathan Becker, Team Leader Arnet Jones, Chief Herbicide and Insecticide Branch Biological and Economic Analysis Division REVIEWED BY PRP: September 26, 2001 TO: Christina Scheltema Betty Schakleford Reregistration Branch Special Review and Reregistration Division (7508C) CC: Denise Keehner, Director Biological and Economic Analysis Division SUMMARY All applications of disulfoton on the crops in this assessment are made by groundboom. Cole crops, lettuce, chili peppe rs use the liquid formulation, w hich is either shan k injected o r in­ furrow at pla nt. Disulfoton, b oth granular and liquid, is currently applied in­ furrow at plant on cotton and beans, snap and lima. BEAD believes that the cotton an d bean gr owers would switch to gra nular if the liquid fo rmulation wa s no longer a vailable. Background Special Review and Reregistration Division (SRRD) has asked BEAD to evaluate the benefits of disulfoton for lima beans, snap beans, cole crops, lettuce, chili peppers, and cotton. The Health Effects Division (HED) has calculated the margins of exposure (MOE) to be of concern for mixer/ loaders and handlers. For the EC formulation of disulfoton, the MOEs were calculated to be 20 and 30, for mixer/ loader and handler, respectively. For the granular form ulation, HE D has calc ulated M OEs of 8 00 and 9 6 for mixer/ lo ader and handler, resp ectively. Additionally, aerial applications have much lower MOEs than do groundboom applications for mixer/ loader and handler. Postapplication risks were calculated for those sites that allowed foliar application. In this assessment, that includes only cotton, which had an MOE of 108 one day after treatment. Therefore, post application activities have not been inc luded in this asse ssment. 2 SRRD has requested that BEAD investigate the importance of liquid and granular formulations, and aerial applications of disulfoton. Cole Crops and Chili Pepp ers Cole crops assessed include broccoli, cauliflower, cabbage, and Brussels sprouts. Chili pepper production is similar to the co le crops an d the pest pr oblems ar e the same, so it is included in this sec tion. The m ajority of cole crops produc tion occurs in California. New M exico produces most chili peppers in the United States. Most disulfoton applied to these crops is in California. Use of disulfoton has been decreasing, probably due to the recent registration of im idacloprid . Disulfoton is u sed to con trol several sp ecies of aph ids on cole crops and chili peppe rs; it is especially efficacious against the cabbage aphid. It is shank injected when the plants are 4­ 5 weeks old and the aphids have exceeded the economic threshold. The formulation of disulfoton used is based upon the fertilizers, fungicides or herbicide s that will be shank injected at the same time, usu ally the liquid form ulation. Currently, imid acloprid is a pplied at­ p lant, but imidac loprid alo ne cannot control the ca bbage aphid throughout the entire growing season due to its limited period of residual effectiveness. Imidacloprid is not effective as a foliar app lication. The refore, orga nophosp hates are still nece ssary to insure ap hid­ free head s or florets. Alternatives to disulfoton are oxydemeton­ methyl and dimethoate. Chlorpyrifos is also registered, but it is injurious to beneficial ins ects and has some phyto toxicity prob lems at the high ra tes required to control the cabbage aphid. Lettuce Most of the United States iceberg lettuce (96%) and leaf lettuce (97%) is produced in California and Arizona. California treated about 2­ 3% of the iceberg and 1% of the leaf lettuce acreage with disulfoton in 1999 (Kurtz, pe rsonal com munication; CA Pestic ide Use R eport data , 1999). The primary pest targeted by disulfoton on lettuce is the root aphid . Disulfoton is applied at­ plant or as a pre­ plant application and incorporated into the soil. It is only applied in the liquid formulation since the site was removed from the granular label in the late 1990s. It is not shank injected because this would put the active ingredient below the shallow root system of the lettuce plants (Kurtz, personal communication). The recent decline in d isulfoton use o n lettuce may ha ve occurred due to the registration o f imidaclop rid and a strong program to remove Lombardy Poplar trees from residential and park areas. The poplar trees are a primary host for the root aphid. The reduction of these ornamentals near lettuce production has reduced the root aphid populations enough for imidacloprid to control most problems. However, there are still a few hot spots  of root aphids and these are the areas that still require disulfoton applications. There are no other effective alternatives to this particular aphid. Beans, Lima and Snap Fresh lima beans are primarily produced in Georgia. Disulfoton is applied at­ plant to control thrips. Based on a survey o f county extensio n agents, Dr . Adams re ported tha t anywhere fro m 20­ 30% of lima b ean growers in Georgia use disulfoton , both liquid a nd granular formulations . The only alternative for thrips for lima beans would be foliar applications of acephate. Imidacloprid is not registered for this vegetable, and the expense would prohibit its use if it should get registered (Adams, personal communication). The crop profiles for snap bean production in Michigan does not recommend disulfoton. Although, other 3 Michigan publications recommend the granular formulation at plant (Rosenbaum, personal communication). The New York crop profile recommends only in­ furrow application at­ plant for potato leafhoppers. However, extension entomologists at Cornell do not recommend disulfoton as part of an IPM strategy. The potato leafhop per is a sporadic pest and d oes not req uire contro l every year. T hey advise gr owers to wa it until they have a p roblem with the insects befo re treating, and then applying acephate, carbaryl, me thomyl or dimethoate. D isulfoton is still recommended at­ plant if neighbo ring fields have identified pro blems with potato leafho pper. Ad ditionally, processo rs will disqualify any b eans treated with systemic insec ticides at­ plant un less the abov e condition is substantiated by extension agents (Pe tzoldt, perso nal communication). Disulfoton is applied to beans as either a liquid or granular formulation. The formulation decision appears to be based upon whether the grower is applying fertilizer or herbicide at the same time. Although there is limited information to accurately a ssess impact of eliminating the liq uid formulation, BEA D believe s that doing so would not be a pr oblem to the majority o f growers. H owever, the re is a need fo r disulfoton in lim a bean, and occassion ally in snap bea n, produc tion. Cotton Disulfoton is the insecticide of c hoice in area s that use clom azone to c ontrol the we eds: velvetlea f, primrose, and mo rning glory. Clomazone is the herb icide of choice in these areas bec ause it is very effective against these weeds and is less cos tly than the other h erbicides. D isulfoton wor ks as a safener w hen clomazone is used . Disulfoton is a pplied in­ furro w with the seed , while clomaz one is app lied as a ban d on top. T he liquid form ulation is preferred as it appears to be a better safener and more effective than the granular formulation at protecting the cotton seedlings against thrips. However, the alternative, phorate, is applied as a granular formulation although it is not as efficacious against the thrips. Another alternative, aldicarb, is very effective against thrips but do es not act as a safener. (Lentz and Leona rd, personal comm unications) Use of disu lfoton in cotto n has been declining. T his has been attributed to the introduction of glyphosate tolerant (round­ up­ ready®) cotton. However, the percentage of acreage that can be planted with glyphosate tolerant cotton is restricted. Therefore, in areas without the modified cotton, herbicides that are efficacious against the aforementioned weeds are still necessary and subsequently so is disulfoton (Adams and Leonard, personal communications). The cotton growers would probably switch to the granular formulation if the liquid formulation was no longer available. Maximum Acres Treated Cole Crops and Chili Pepp ers According to Mr. B reschini, a custo m applica tor, his comp any applies d isulfoton on up to 40 acre s/ day, maximum, usually less. He said that it is shank injected with fertilizer, when the plants are about 4 to 5 weeks old, and the co nsultants have b een identifying a phid pro blems. Ad ditionally, if the area is having an ap hid outbre ak, his company may apply disulfoton for u p to 4 wee ks, but has nev er applied it more than 3 times in one we ek, and usua lly only twice a week. Also, as a commercial applicator, the company has several mixer/ loaders and applicators, so Mr. Breschini said it is highly impro bable that the same peo ple would be making all the disulfoton application s. Lettuce Lettuce in California is usually planted in blocks of 8­ 12 acres. Planting is staggered so that growers can harvest throughout the growing season. Disulfoton is applied in liquid formulation with herbicide at planting. The maximum acreage that could be treated in one day is 40, although 20 acres a day is probably more likely. With a commercial applicator, there may be 2 to 3 days of planting in a row, however, it would be unlikely that the same 4 application team would be making all of the applications. A private grower would be only able to plant 2 blocks or about 40 acres in a day. It is unlikely the private grower would plant more at one block at a time, otherwise, the staggering plan would not be in effect (Kurtz, Platts, personal communications). Cotton Southern c otton farms te nd to be ab out 1,000 Acres +/­ 10 %. Gro wers usually ow n 2 or 3 p lanters. Generally a planter can plant 100 ­150 A/ d ay. Under most circum stances a gro wer will have his fa rm planted within 3 days; however, the process can take up to 7­ 10 interrupted days if problems arise (weather, usually) (Leonard, personal communication) References Agricultural Statistics 2000. NASS, USDA Agricultural Statistics 2001. NASS, USDA California P esticide Use Reports d ata, 1999 . Crop Profile for Peppers (Chile) in New Mexico. March 2000. USDA Crop Profile for Broccoli in California. August 1999. USDA Crop Profile for Brussels Sprouts in California. November 1999. USDA Crop Profile for Cabbage in California. 2000. USDA Crop Profile for Cauliflower in California. January, 2000. USDA Crop Profile for Cotton in Alabama. Prepared December 1999. USDA Crop Profile for Cotton in Arkansas. Prepared August 1999. USDA. Crop Profile for Cotton in Tennessee. December, 1998. USDA. Crop Profile for Cotton in Texas. Prepared September 1999. USDA. Crop Profile for Lettuce (Iceberg) in California. March 1999. USDA. Crop P rofile for Lettuc e (Leaf) in Ca lifornia. April 1 999. USDA. Crop P rofile for Be ans (Snap ) in Michiga n. Prepar ed August 1999. U SDA. Jackson, L ., K. Mayb erry, S. Ko ike, F. Laem mlen, K. Sc hulback, an d W. Chaney. Leaf L ettuce Pro duction in California. U niversity of Califo rnia, Division of Agriculture and Natu ral Resour ces, Public ation 721 6. David Adams. Extension Ento mologist, U niversity of Ge orgia. Les Breschini. John P ryor and C ompany, Salinas, Califor nia (a profes sional fertilizer co mpany) Edward A. Kurtz. California Lettuce Research Board. 5 Gary Lentz. Cotton E ntomologist. University of T ennessee  Knoxville Roger Leonard. C otton Ento mologist, Lo uisiana State U niversity. Curtis Petzo ldt. Vegetab le IPM Co­ ordin ator, Corn ell University. Belinda P latts. Pest Con trol Agent. D ole Fresh F oods. Robin Rosenbaum. Pesticide Registration P rogram M anager, M ichigan De partment o f Agriculture. Ron Smith. Cotton E xtension En tomologist. Auburn U niversity.

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EPA-HQ-OPP-2002-0055-0020

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Memorandum SUBJECT: Benefits Assessment for Disulfoton Use on Potatoes and Radish Seed FROM: Nikhil Mallampalli, Entomologist Herbicide and Insecticide Branch Colwell Cook, Entomologist Herbicide and Insecticide Branch Anthony Gilbert, Economist Economic Analysis Branch Biological and Economic Analysis Division ( 7503C) THROUGH: David Brassard, Senior Scientist Art Grube, Senior Economist Arnet Jones, Branch Chief Herbicide and Insecticide Branch David Widawsky, Branch Chief Economic Analysis Branch Biological and Economic Analysis Division ( 7503C) TO: Christina Scheltema, Chemical Review Manager Betty Shackleford, Branch Chief Reregistration Branch 3 Special Review and Reregistration Division ( 7508C) September 26, 2001 Summary of Analysis This assessment investigates the pest management and economic benefits of the use of liquid disulfoton in potatoes and radishes, in the context of mitigation proposed for risks faced by mixer/ loaders and applicators of this insecticide. Disulfoton appears to have very different benefits in the production of each of these crops. In potatoes, while disulfoton has historically been an important component of the chemical arsenal used against aphid pests, its use in the past two years or so has declined greatly. It is now used on a small proportion of the total US crop, though in some areas, particularly Idaho, it remains an insecticide of some importance. This reduction in use is largely a result of the development of effective alternative insecticides. As long as the currently available insecticide options exist, however, growers should still be able to achieve adequate control of pests, though perhaps less economically, without liquid disulfoton. In radishes grown for seed, liquid disulfoton use is a much more important pest management tool for those growers operating in Washington state. Producers in this region face aphid pests not seen in other areas, and have many fewer chemical alternatives available to them, as compared to potato growers. The economics of radish seed production create a small profit margin and this also contributes to the importance of disulfoton, which is both cheap and efficacious in its liquid form. Thus, in this crop, and for this region in particular, liquid disulfoton use has critical benefits and risk mitigation should be carefully considered. Background Disulfoton is an organophosphate insecticide used on a wide variety of crops in part because it not only has contact toxicity but is also taken up by plant root systems and remains active against target insects for a relatively long time. It is available for both the crops addressed here in both liquid and granular form. Risk modeling by the Health Effects Division indicates that this chemical may pose the greatest hazards to mixer/ loaders and applicators if the liquid form is applied aerially or via chemigation. Furthermore, the liquid form is more hazardous than the granular form ( regardless of application method) . Therefore, SRRD has asked BEAD to investigate the importance of liquid disulfoton in U. S. production of potatoes and radishes grown for seed, as well as the impacts created by restrictions on these pest control practices. Role of disulfoton and chemical alternatives available in potato production Disulfoton has historically been used as one of many insecticides in this crop to control aphid infestations across the U. S. The main targets of this use are the green peach aphid, Myzus persicae , and the potato aphid, Macrosiphum euphorbiae . During the period from 1987­ 1998, an average of 4 % of the nation s potato acreage was treated with this chemical, and in 1999, the National Potato Council asserted in a letter to EPA that it was an important component of aphid pest management, in both its granular and liquid forms. In addition to suppression of pest populations, disulfoton is also used to manage resistance to organophosphate insecticides, a phenomenon common in the targeted aphid species. Granular disulfoton is applied at planting to control early season aphid populations. A subsequent application of liquid disulfoton may also be made during the growing season, either aerially, by ground sprayers, or chemigation. However, the latest USDA/ NASS statistics available indicate that in 1999, an average of only a single application was used in the states surveyed ( including Colorado, all Pacific Northwest growing regions, Indiana, Maine, Minnesota, North Dakota, Pennsylvania, and Wisconsin) . Since 1999, the average U. S. acreage treated with disulfoton has declined to 1 % ( USDA/ NASS statistics, 2000) . Indeed, in some states ( Delaware, Florida, North Carolina) growers apparently no longer apply this insecticide, and it is not listed as an insecticide option in crop profiles published by extension services in these states, despite current registration ( USDA Crop Profiles for Delaware, Florida, Ohio, North Carolina, and Pennsylvania) . In Idaho, however, disulfoton use is higher than the national average. The latest published information indicates that 4 % of the total acres grown were treated with disulfoton ( USDA Crop Profile) . This use appears to be predominantly of the liquid form. In some areas of Idaho the systemic uptake of disulfoton by plants translates into less harmful effects on beneficial insects such as pollinators, which are important in adjacent crops such as alfalfa ( A. Schreiber, R. Stoltz, pers. comm . ) . Some growers in Washington state also use disulfoton, for the same reason ( A. Schreiber, pers. comm . ) . Disulfoton is applied aerially in these regions so as not to damage potato vines ( as would occur if ground spray equipment were used) . In Washington an estimated 90 % of disulfoton applications are of the liquid form, applied aerially ( A. Schreiber, pers. comm . ) . No such information has been provided for Idaho. Reduction in disulfoton use in recent years has apparently occurred largely because of the registration and adoption ( by growers) in the past two years, of other insecticides for similar purposes in potato ( A. Schreiber, R. Stoltz, M. Aerts, pers. comm . ) . These include imidacloprid, pymetrozine, and thiamethoxam. These chemicals join a set of other insecticides that together provide adequate control of the target pests in most regions of production. Information provided by extension service contacts in Florida suggest that the insecticides that are currently used most commonly against the aphid pests principally targeted by disulfoton are methamidophos, aldicarb, and imidacloprid ( M. Aerts, pers. comm . ) . Like disulfoton, both imidacloprid and methamidophos have good systemic activity against aphids ( Crop Profiles for Wisconsin, Idaho) . Furthermore, imidacloprid, in particular, also controls other pests, such as the Colorado potato beetle and whiteflies, that often occur at the same time as aphids and are not as well managed with disulfoton ( Crop Profiles for Florida, Wisconsin) . These aspects have probably 2 contributed to the adoption of these insecticides for pest control in potatoes. Role of disulfoton and chemical alternatives available in the production of radishes grown for seed In this crop, disulfoton is used only by growers in the Columbia basin area of Washington state, on a special local needs ( ( 24c) label. Radish seed is a minor, but economically important crop for producers in the Columbia Basin of Washington. Production from here is utilized domestically and internationally for growing fresh radishes for consumers. Radish seed is grown in regions where cool, wet seasons consistently predominate, and in the U. S. the crop has historically been grown in the Pacific northwest and California ( McGregor, 1976) . Further information on the current extent of the total U. S. crop are not available, however, as it does not appear to be tracked by USDA s agricultural surveys. The crop is an annual one, and, in Washington, it is planted in March and harvested in August ( G. Pelter, pers. comm ) . Disulfoton use is targeted toward two aphid species, the cabbage aphid ( Brevicoryne brassicae ) and the turnip aphid ( Rhopalosiphum pseudobrassicae ) . They cause premature crop senescence, which results in yield loss and/ or loss of seed quality. They also make harvesting very difficult when their sticky honeydew ( ( excreta) coats machines. Growers operate with a slim profit margin and produce a relatively small acreage of this crop ­ 635 acres total in this area in 2000 ( G. Pelter, pers. comm . ) . As a result, aphid damage, if not rigorously controlled, could easily be catastrophic for individual farmers. Disulfoton is applied in both granular and liquid form on radishes in this region, and virtually all acreage receives one application, early in the growing season after seed stalks form on plants. Growers usually apply the insecticide themselves ( G. Pelter, pers. comm ) . Liquid disulfoton is applied as a soil injection in combination with a fertilizer. The application to an average field ( typically 20 to 25 acres in size) takes an estimated four hours at most. Thus, a grower would be typically exposed to disulfoton only once annually, and only during mixing­ loading operations ( G. Pelter, pers. comm . ) . Pirimicarb, chlorpyrifos, pymetrozine are the only registered chemical control alternatives available to growers for these insect pests. Pirimicarb is already used once to control late­ season infestations of these aphids, if at all. Chlorpyrifos cannot be used during bloom, when aphids can occur, due to toxicity to honey bees that pollinate this and other nearby crops. Pymetrozine is relatively expensive and does not provide good lower canopy control. Disulfoton is also advantageous in that it allows predatory and parasitic insects to develop in seed radish fields, since other insecticides are not utilized until later in the growing season ( if at all) . As a result disulfoton is considered an important part of the industry' s IPM program ( G. Pelter, pers . comm . ) . Economic impact of mitigation of disulfoton risks in potato Curtailing liquid application of disulfoton could motivate growers to switch to other registered alternatives, such as imidacloprid, or increase the applications of methamidophos in addition to the current pesticide control regime. In order to estimate the economic impact to the potato industry, disulfoton was compared with methamidophos and imidacloprid using a five year historical range of production costs and grower revenues. Washington State, Idaho and Wisconsin were selected for this analysis. In 2000, these three states together harvested over 60 % of the total US market supply of potatoes and generated a combined total of $ 1.3 billion of revenue. Washington State and Idaho applied an average of 11,000 lbs of disulfoton in 2000. Using the worst case scenario for this analysis, an additional application of methamidophos could result in an $ 11 increase in the cost of chemical inputs per season. Applying the maximum label rate for imidacloprid could increase grower costs approximately $ 45 per season. Replacing disulfoton with methamidophos or imidacloprid in Washington State could result in economic losses for the local potato industry of approximately 0.3­ 1.6% per year. The Wisconsin potato industry could potentially lose 0.5­ 2.3 % as a result of mitigation. The most severe impact of mitigation could occur in Idaho, where economic losses to the potato industry are 0.7­ 2.9 % per year, at most. Thus, the potential economic loss resulting from substituting either methamidophos or imidacloprid for disulfoton would appear to cause a negligible economic impact given the potato industry s overall gross earnings. Economic impact of mitigation of disulfoton risks in radishes grown for seed 3 Economic data for radish seed are scarce and information could be found for only 635 acres in Washington State. Based on information from Washington state, break­ even analysis shows that growers are currently operating under very narrow profit margins. Given a $ 0.93 break­ even price per pound of radish seed and average prices for radish seed at $ 0.93 per lb, an increase in production costs could negatively impact grower operations significantly. Washington State University agricultural extension agent Gary Pelter claims that without liquid disulfoton, growers would have to purchase new equipment in order to apply a granular form of the chemical. The cost to purchase this equipment and switch to a new formulation, Mr. Pelter states, would be in excess of $ 9,000 per grower. He also estimates that the cost of applying liquid fertilizer separately would add about $ 40 per acre to a grower s production costs. Therefore, impact of mitigation could create a severe economic burden to an apparently fragile radish seed industry. Sources and references Mr. Michael Aerts, Florida Fruit and Vegetable Association, Orlando, FL. Mr. Gary Q. Pelter, Washington State university Cooperative Extension Service, Ephrata, WA. Dr. Alan Schreiber, Agriculture Development Group, Pasco, WA. Dr. Robert Stoltz, University of Idaho, Twin falls, Idaho. Potato Association of America Handbook ­ Marketing and Economics web site at: www. css. orst. edu/ classes/ CSS322/ marketing. html . USDA Crop Profile for Potatoes in Delaware, June 2000. USDA Crop Profile for Potatoes in Idaho, June 2000. USDA Crop Profile for Potatoes in Idaho, June 2000. USDA Crop Profile for Potatoes in Florida, December 2000. USDA Crop Profile for Potatoes in Idaho, June 2000. USDA Crop Profile for Irish Potatoes in North Carolina, November 1999. USDA Crop Profile for Potatoes in Wisconsin, September 2000. USDA/ NASS Agricultural Statistics 1999, 2000 and 2001. 1997 Enterprise Budgets: Carrot Seed, Radish Seed, and Onion Seed; Columbia Basin, Washington. Gary Pelter and Herbert Hinman. Washington State University. USDA/ NASS Agricultural Chemical Usage, 1999 Vegetable Crop Summary. USDA 1997 Census of Agriculture; Volume 1 Geographic Area Series; Part 12: Idaho. USDA 1997 Census of Agriculture; Volume 1 Geographic Area Series; Part 47: Washington. 4

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EPA-HQ-OPP-2002-0055-0021

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Memorandum SUBJECT: Use of Disulfoton on Bell and Pimento Peppers (Barcode D278640) FROM: Colwell A. Cook, Entomologist Herbicide and Insecticide Branch Istanbul Yusuf, Econo mist Economic Analysis Branch Biological and Economic Analysis Division (7503C) THROUGH: David Brassard, Senior Entomologist Arnet Jones, Chief Herbicide and Insecticide Branch Arthur Grube, Senior Economist David Widawsky, Acting Chief Economic Analysis Branch DATE OF BEAD PEER REVIEW: October 31, 2001 TO: Christina Scheltema, Chemical Review Manager Betty Shackleford, Chief Reregistration Branch 3 Special Review and Reregistration Division (7508C) CC: Denise Keehner, Director Biological and Economic Analysis Division Introduction Special Review and Reregistration Division has requested that the Biological and Economic Analysis Division (BEAD) examine the use of d isulfoton on sw eet pepp ers and pim entos in resp onse to an inq uiry from the C alifornia Pepper Commission. The Commission claims that use of disulfoton on sweet peppers and pimentos is the same as on chili peppe rs. BEAD investigate d the claim an d the results follo w. Summary Produc tion practice s and pest co ntrol of bell pe ppers and pimentos a re the same fo r chili pepp ers. Appro ximately equal acreages of bell and chili peppers in California are treated with disulfoton. Application of disulfoton is shank injected of the liquid formulation as a side­ dress when the plants are 4­ 5 weeks old. The primary insect pest on peppers is the green p each aphid which also transmits a mo saic viral diseas e that kills the plants. Background Peppers Bell or sweet, chili or hot, and pimiento peppers are Capsicum annuum, L. All domesticated peppers are varieties of C. annuum. There is a w ide variety of fruit co lor and sha pes. The bell or swee t pepper h as a large blo cky fruit with 3 or 4 lobes and is harvested as mature green fruit. Many colors of fruit have been introduced into the commercial markets. Chili, chile, hot, cayenne peppers are tapered, slender, thin walled and highly pungent. Chili peppers are usually harveste d when the fru it is red. Pimiento (pimento) are large, co ne­ or heart­ sha ped, thick­ wa lled fruit usually are not p ungent and harvested w hen fully red (R ubatzky and Yamaguchi, 1997). In 2000, the US harvested 70,650 acres of bell peppers, California harvested 41% of the total. In 2000, the US harvested 3 1,400 a cres of chili pe ppers, N ew Mexico harveste d 57%, and Califor nia harvested 12% o f the total. NASS has not surve yed pimento pepper produ ction. Near ly 2,000 ac res of bell pe ppers, ab out 1,600 acres of chili peppers, and 37 acres of pimento peppers in California were treated with disulfoton in 1998. New Mexico applies nearly 4,400 lbs of disulfoton to its peppers. For all peppers there is one application at a median rate of 2 lbs ai/ acre (2001 Agricultural S tatistics, EPA proprieta ry data). Green P each Aphid In bell pep pers, the prim ary insect pest d riving disulfoto n use is the green peach ap hid, Myzus persicae (Sulzer). This insect is found throughout the world and attacks over 800 species of plants, including all solanaceous crops such as peppers. T his insect vectors 50 plant viral diseases (D avidson and Lyon, 1987). In pepp ers it transmits a mosaic virus that rapidly kills the plant. This aphid prefers shade­ grown plants (Davidson and Lyon, 1987); therefore, the fo ggy Salinas V alley is prime ha bitat as also pr ovides num erous alterna tive hosts. Th is insect is notorious for developing resistance to insecticides, therefore having several compounds available is necessary for insecticide res istance mana gement. Cu rrently, disulfoton remains efficac ious to the gre en peach aphid. Symphylans The garden symphylan, though n ot an insect, is be coming a p roblem fo r peppe r growers in C alifornia. The se pests feed on the r oot systems o f many vegetables, small fruits, and speciality crop s like mint. Con trol of symphyla ns is difficult due to the ir vertical and la teral movem ent in the soil. Som e control m ay be gained by a 2 to 3 w eek flood in the spring or fall or by tilling the soil in the spring (Berry, 1998). The former is impractical in most situations and the latter is not po ssible in reduc ed­ or no­ till situatio ns. Chemical Use In bell and pimento peppers, disulfoton is shank injected as a liquid side­ dress when the plants are around 4 to 5 weeks old (Fisher; Chuck, personal communication). Mr. Chuck said that growers are already set­ up with closed cabs and closed systems for the liquid formulation of disulfoton. He has no idea how to use or apply the granular formulation. He is conc erned ab out equipm ent costs and whether the gr anules would be efficacio us long eno ugh to protect peppers from the aphids and viral disease (Chuck, personal communication). Other compounds registered for use in bell peppers for green peach aphid are imidacloprid, diazinon, dimethoate, malathion and pyrethrins . Neither dia zinon nor m alathion is very e fficacious aga inst the green p each aphid. Dimethoate is frequently used and much less costly, but in some areas of CA and NM it is no longer effective for aphid control. Use of imidacloprid has been increasing, but, again, in some areas of CA control of this pest has been less than satisfacto ry. Pyrethroid s do not fit well with in tegrated pe st managem ent (IPM ) strategies since th ey will annihilate the p redators a nd parasito ids as well. Farm Size According to Mr. F isher, most of the members of the CA P epper C ommission farm appr oximately 20 0­ 300 acres. Bell pep pers or pim entos acco unt for anywhe re from 50 to 100 ac res. Mos t growers pla nt 3 vegetab les, commo nly one third of their acreage in peppers, one third in lettuce and a third in broccoli. Nearly 50% of the pepper growers use commercial applicators to apply disulfoton (Ludwig, personal communication). Progress The California Pep per Com mission was fo rmed seve ral years ago in response to pressure fro m the green peach ap hid and the mo saic virus. Th ey have bee n actively supp orting resear ch to identify resista nt cultivars to the m osaic virus. Although the y have not be en successful in a ttaining their goa ls, they are interested in reducing the pesticides use d in their industry (Fish er, persona l communication). References Berry, Ra lph E. 199 8. Insects and Mites of E conomic Importa nce in the N orthwest, 2 nd ed. Chuck, Mike. Pepper Grower, California. Personal communication 10/ 18/ 01. Davidson, Ralph and William Lyon. 1987. Insect Pests of Farm, Garden and Orchard, eighth edition. John Wiley and Sons, New York. Fisher, Glen. Chair CA Pepper Commission. Personal communication 10/ 18/ 01. Ludwig, Gabrielle. Schr amm and Williams, A ssociates. Pe rsonal com munication 10/ 19/ 0 1 and 10 /25/ 01. Rubatzky, Vincent and Mas Yamaguchi. 1997. W orld Vegetables: P rinciples, Production, and N utritive Values. Chapman and H all, New Y ork. 2001 A gricultural Statistics. N ASS. USDA.

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EPA-HQ-OPP-2002-0055-0022

Supporting & Related Material

Cursory assessment of disulfoton use in coffee in Puerto Rico By : Nikhil Mallampalli, BEAD/ HIB To : Christina Scheltema, SRRD As per DP Barcode # : 279009 Disulfoton is available only in the 15 % granular form for coffee production in Puerto Rico. It is registered under a section 24( c) label, for control of leafminers ( larvae of the moth, Leucoptera coffeella ) . This insect, left uncontrolled, can cause up to 50 % reduction in photosynthetic activity and 40 % reduction in yield 1 . As such, this pest can pose a major economic problem, since coffee crops in Puerto Rico provide a gross income of approximately $ 30.3 million 3 . Of about 50,000 acres planted to coffee in 2000, approximately 15.3 % ( 7,636 acres) were treated with disulfoton 1 . The insecticide is also applied to plants in nursery production, with an unknown amount of the total product being treated. Treatment of coffee in the field is carried out exclusively by government employees ( known locally as the A Brigades @ ) , as this is cheaper for individual growers. Nursery applications are carried out by growers themselves 1 . Rates of application in fields vary according to the age of the plants involved. They are 0.25, 0.5 or 1 oz for newly planted, 2 nd year, and in­ production trees, , respectively. This represents 20 lb ( = 3 lb active ingredient) , 30 lb ( = 4.5 lb active ingredient) , and 60 lb ( = 9 lb active ingredient) per acre, of granular 15% disulfoton 2 . These estimates are based on an assumption of 1,000 trees per acre 2 , though some newer varieties can be planted at 1,500 trees per acre. Fields with these ( unspecified) varieties would require commensurately greater active ingredient 1 . Nursery applications are broadcast at an approximate rate of 0.5 gm ( = 0.08 gm active ingredient) per plant. Plants in nurseries are kept in polyethylene bags, 3 3.5 inches in diameter and 10 inches deep 1 . All applications of disulfoton are made using a bucket and spoon. This is their time­ honored method, and has been used for about 37 years 1 . Early attempts to use a Swiss­ Mix , a belly­ grinder type of spreading device used in Puerto Rico to apply aldicarb, were unsuccessful, due to rapid damage of the mechanism from the abrasive disulfoton granules 1 . Growers and extension staff appear receptive to alternative, more closed, systems of application. It is noteworthy that the application rates quoted above are based on efficacy studies done in the 1950s, by Puerto Rican scientists who used a 10 % granular formulation of disulfoton 2 , as opposed to the currently used 15 % formulation. Aldicarb ( Temik) is the only currently available alternative to disulfoton in this crop that is believed to have some effectiveness against leafminers. It is considered by growers and extension service staff to be less effective than disulfoton, and was applied to only about 3,500 acres in 2000 1 . Aldicarb is also slightly more expensive than disulfoton 1 . Azadirachtin is also registered for use against leafminers and a variety of other insects in coffee, but is unlikely to be as beneficial as disulfoton, since it has no systemic residual activity, and breaks down on plant surfaces rapidly. The extension service staff that were consulted do not list it as a control option for coffee growers in Puerto Rico 1 . Sources 1. Acin, N. , R. Ingles, and M. Monroig. University of Puerto Rico, Mayaguez, PR. 2. Cibes, H. , and M. Perez. 1957. Informe Oficial EEA, UPR, No. 33. 3. Office of Agricultural Statistics ( OAS) . 1999. Gross farm income of Puerto Rican agriculture; 1997­ 1998. Puerto Rican Department of Agriculture, San Juan, PR. Pp 20­ 21.

epa

2024-06-07T20:31:41.760207

regulations

EPA-HQ-OPP-2002-0055-0023

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Memorandum SUBJECT: Responses to Questions Concerning Disulfoton Posed by Special Review and Reregistration Division FROM: Colwell A. Co ok, Entom ologist Nikhil Mallampalli, Entomologist Herbicide and Insecticide Branch Anthony Gilbert, Eco nomist Economic Analysis Branch Biological and Economic Analysis Division THROUGH: David Brassard, Senior Entomologist Arnet Jones, Chief Herbicide and Insecticide Branch Biological and Economic Analysis Division Arthur Grube, Senior Economist Economic Analysis Branch Biological and Economic Analysis Division BEAD PEER REVIEW DATE: 12 December 2001 TO: Christina Scheltema Michael Goodis Betty Shackleford, Chief Special Review and Reregistration Division CC: Denise Keehner, Director, OPP/ BEAD Introduction A meeting was held on November 28, 2001 between Special Review and Reregistration Division (SRRD) and BEAD concerning disulfoton. This memo addresses questions posed by SRRD during the meeting. The questions ranged from general information to help SR RD complete the IRED to verifying concerns from growers. This memo contains p roprietary d ata and is for O PP use o nly. Questions And Answers 1. The Pacific Northwest (PNW) primarily uses the liquid formulation of disulfoton on potatoes. Is the granular product needed for use outside the PNW? Granular disulfoton (15G), like the liquid (8EC), is used at a relatively low level nationwide. However, more crop area (nationwide) is treated with granular than with liquid, according to Doane s data. In 2000, about 11,000 acres were treated with 15G, 8,000 with 8EC. This is equivalent to about 1% of the 2000 crop treated with 15G, as compared to about 0.6 % treated with 8EC. Some extension services still list granular disulfoton as a pest control option, which is presumably followed by growers in their regions. These include: Texas, North Dakota, New York, Delaware, and Colorado ­ all states outside the PNW. Taken together, these results suggest greater reliance on granular disulfoton in potato production outside the PNW. However, since granular disulfoton is used on less than 2% of the national potato crop, its use may reasonably be characterized as somewhat low. 2. There was an SLN in 1992 for North Carolina peanuts. Where is disulfoton on peanuts used? What are the formulations an d the target pests? Only the granular formulation of disulfoton is registered for use on peanuts. There is a Section 3 label for nationwide use on this crop. However, North Carolina has a 24( c) label that allows two applications per season instead of the sin gle applica tion allowed elsewhere. T hrips are the m ain targeted p est, though in so me areas (e .g., Texas), aphids are also listed as targets (USDA Crop Profile) of peanuts. The main thrips species involved is the tobacco thrips, Frankliniella fusca. Doane's data indicate usage in peanuts in the following states in 2000: Alabama, Georgia, North Carolina, and Oklahoma. 3. Is it reasonable to narrow the scope of the 15G label to gladiolus in Florida, deciduous (birch) trees in New England and New York state? Ho w narrowly ca n EPA define the use of disulfoton o n ornamentals? Unknown. The ornamental industry is quite varied, not only because there are well over 600 species of plants grown commercially, but there is little common practice among nursery and floriculture producers. We do know that of the 4,000 operations that responded to the NASS survey for Nursery and Floriculture Chemical Usage (to be published Dec. 2001 or Jan. 2002), only 22 operations reported using disulfoton on a total of 56 applications (about 0.1% of reported pesticide ap plications). W ith such low rep orting NA SS will prob ably not con duct much analyses with this chemical. BEAD has not been able to verify the Am erican Nu rsery and La ndscape Association  s claim that disulfo ton is critical to the indu stry and rate red uctions belo w 13 lbs ai/ A will cause significan t harm to the nu rsery industry. Based o n NASS information sta ted abov e, disulfoton d oes not ap pear to be critical to the indu stry. The Ca lifornia Department of Pesticide Regulation (CA DPR, years 1997­ 1999) database does not have any record of use above 6 lbs ai/ A. There are a couple of growers of birch trees in NY that do use disulfoton at the 13 lbs ai/ A rate, but they offered no evidence why such a rate is necessary. At this time, BEAD believes the critical need of disulfoton to be low. 4. How much disulfoton is used on lettuce and co le crops in California, spe cifically the Salinas Valley, vs. the rest of the country? Where and how much of the granular formulation of disulfoton is used for cole crops and peppers? If there is no use of the granular, does it make sense to cancel? The table below examines the amount of disulfoton that has been used on the selected vegetables in CA. Salinas Valley encompasses Monterey, San Benito, Santa Clara and Santa Cruz Counties. Since Monterey County is the largest prod uction area it is the subject of the table. Site Pounds of Disulfoton applied to the Site in CA (3 yr Average: 1997­ 1999) 1 % of the CA Disulfoton used by Site in Monterey Co., CA Broccoli 8617 60 Brussels Sprouts 394 87 Cabbage 2 3117 <1 Cauliflower 1114 52 Lettuce, head 8883 59 Lettuce, leaf 2377 57 1 Data from the CA DPR database and includes years 1997­ 1999. 2 Ventura Co, not part of Salinas Valley, is maximum user of disulfoton in CA, 3 yr average of 83% of disulfoton applied to cabbage. Also, from the CA D PR database (years 1997­ 199 9), an average of 85,6 17 lbs of disulfoton was app lied to 36 crops, about 29% of which was applied in Salinas Valley. The majority of disulfoton was applied to asparagus (about 45%), of which less than 10% is gr own in Salina s Valley, CA . USDA NASS Agriculture Chemical Usage Vegetable Summary 2000 has limited information. The low number of reports of d isulfoton are p robably b ecause the u sage is low on vegetable c rops othe r than aspara gus. Broccoli Production: CA, AZ, TX; with 6% of CA broccoli treated with disulfoton (7,200 lbs). Cabbage Production: CA, NY , TX, NC; with all states reporting some use. Only 3% of total cabbage produced was treate d with a total of 3 ,400 lbs d isulfoton nation wide. Cauliflower Production: CA, AZ, NY; no reported use in AZ or NY. Lettuce Production: CA, AZ; no reported use in AZ. Bell Peppers: CA, FL, NC, GA; no reported use in FL, NC, or GA. About 85­ 87% of disulfoton is applied as the liquid formulation on asparagus, broccoli, cabbage, cauliflower, lettuce, and peppers, both nationally and in California. If EPA cancels the granular formulation of disulfoton on these crop s the smaller gro wers would bear the ec onomic impact, either b y investing in new a pplication e quipment, by hiring com mercial ap plicators, or n ot growing the crop.

epa

2024-06-07T20:31:41.763779

regulations

EPA-HQ-OPP-2002-0055-0024

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF 02/ 10/ 2000 PREVENTION, PESTICIDES AND MEMORANDUM: TOXIC SUBSTANCES Subject: Risk Assessment and Reregistration Eligibility Decision (RED) Documents for Disulfoton (Revised Risk Assessment, Phase 4). Chem. No. 032501, Rereg. Case No. 0102 DP Barcode: D262883 Sub DP Barcode of 237133 S526236 PC Code: 032501 CAS Reg No.: 274­ 04­ 4 Caswell File No.: 341 From: David Anderson, Risk Assessor Health Effects Division, OPP (7509C) Through: Alan Nielsen, Branch Senior Scientist Health Effects Division, OPP (7509C) To: Christina Scheltema, Chemical Review Manager Special Review and Reregistration Division, OPP (7508W) This memorandum and six appendices constitute the revised (Phase 4) Risk Assessment and Reregistration Eligibility Decision (RED) documents for disulfoton. Changes from the previous risk assessment (Phase 3) include incorporation of new data and information from revised and updated appendices. Revisions to the appendices include: major changes in the acute and chronic dietary risk to include probabilistic acute dietary risk and use of monitoring data for residues of disulfoton and metabolites of concern in food (Tier 3); minor changes in the occupational/ residential exposure chapter related to public comment; inclusion of the new acute delayed neurotoxicity hen study in the toxicology chapter; the revised hazard identification assessment, and no changes in the product and residue chemistry chapter; or the incident report for disulfoton. Consideration is also given to the Food Quality Protection Act of 1996 (FQPA). Cumulative risk assessment from other pesticides that have a common mechanism of toxicity will be addressed at a future date. ii The attachments include the Revised Toxicology Chapter for the Disulfoton RED (David G Anderson, Appendix 1); the most recent Hazard Identification Assessment Review Committee (HIARC, 1/ 19/ 2000) Report for Disulfoton: Revisit ( David G Anderson, Appendix 2); The FQPA Safety Factor Committee Report for Disulfoton (Brenda Tarplee, 1/ 24/ 2000, Appendix 3); the revised Disulfoton: Acute and Chronic Dietary Risk Assessment (William O. Smith, Appendix 4); the revised Product Chemistry and Residue Chemistry Chapters for Disulfoton RED (John Abbots/ Ken Dockter, Appendix 5); the revised Occupational/ Residential Exposure Chapter (ORE) for Disulfoton RED (Jonathan Becker, Appendix 6) and Memorandum from Jerome Blondell to Jonathan Becker of HED (3/ 25/ 1998), Review of Disulfoton Incidence Reports (Jerome Blondell, Appendix 6). HUMAN HEALTH RISK ASSESSMENT Disulfoton U. S. Environmental Protection Agency Office of Pesticide Programs Health Effects Division (7509C) David Anderson, Risk Assessor February 10, 2000 HUMAN HEALTH RISK ASSESSMENT Disulfoton Phase 4 Risk Assessment Team: Lead Risk Assessor: DavidAnderson Dietary Risk: William O. Smith Occupational and Jonathan Becker Residential Exposure: Epidemiology: Jerome Blondell Toxicology: DavidAnderson Management: Senior Scientist: Alan Nielsen Branch Chief: Pauline Wagner Division Director: Margaret J. Stasikowski, Date TABLE OF CONTENTS 1. 0 EXECUTIVESUMMARY .............................................. 4 2. 0 PHYSICAL/ CHEMICALPROPERTIESCHARACTERIZATION................ 8 3. 0 HAZARDCHARACTERIZATION........................................ 8 3.1 Hazard Profile .................................................. 8 3. 2 EndpointSelection.............................................. 13 3. 3 FQPAConsiderations............................................ 14 4. 0 EXPOSURE ASSESSMENT ........................................... 15 4. 1 SummaryofRegisteredUses ...................................... 15 4. 2 DietaryExposurefromFood ...................................... 15 4.2.1 Acute and Chronic Dietary Exposure Methodology and Characterization .......................................... 16 4. 2. 2 AcuteDietaryRisk( Food) .................................. 17 4. 2. 3 ChronicDietaryRisk( Food)................................. 18 4. 3 WaterExposure( DrinkingWaterSources)............................ 19 4. 3. 1 SurfaceWater............................................ 19 4. 3. 2 Groundwater............................................. 20 4. 3. 3 MonitoringData .......................................... 20 4. 3. 4 DWLOCsforAcuteandChronicExposure ..................... 20 4. 3. 4. 1AcuteDWLOCs .................................... 21 4. 3. 4. 2ChronicDWLOCs................................... 22 4. 4 Occupational/ ResidentialExposure.................................. 23 4. 4. 1 AssumptionsforOccupationalHandler Exposure ................. 23 4. 4. 2 OccupationalHandler ExposureandCharacterization.............. 26 4. 4. 3 OccupationalHandler RisksofConcern ........................ 26 4. 4. 4 DataGaps............................................... 28 4. 4. 5 DataQualityandConfidenceinAssessment ..................... 28 4. 4. 6 PostapplicationExposure ................................... 29 4. 4. 7 HumanIncidenceInformation................................ 30 4. 5 ResidentialExposure ............................................ 30 4. 5. 1 Handler................................................. 30 4. 5. 2 ResidentialHandler ExposureScenarios­ DataandAssumptions ...... 31 4. 5. 3 PostapplicationResidentialExposureandRisk ................... 33 4. 5. 4 PotentialSprayDrift ....................................... 34 5.0 AGGREGATE RISK (FOOD, WATER AND RESIDENTIAL) ................. 34 6.0 ENDOCRINE MODULATION .......................................... 35 7. 0 CUMULATIVE EXPOSURE ANDRISK.................................. 35 2 8. 0 REQUIREDDATA .................................................. 36 9. 0 CODEX............................................................ 36 10. 0 APPENDICES....................................................... 37 Appendix1: ToxicologyChapter fortheDisulfotonRED( DavidG. Anderson) ........... 37 Appendix 2: The Hazard Identification Assessment Review Committee Report for Disulfoton( Revisit)( DavidG. Anderson). ......................... 37 Appendix 3: The FQPA Safety Factor Committee Report on Disulfoton (Brenda Tarplee). . . . 37 Appendix 4: The Revised Disulfoton: Acute and Chronic Dietary Risk Assessment (Includes MRID # 44821701 & 44821702, Chem. No. 032501; William O. Smith) ..... 37 Appendix 5: Product Chemistry and Residue Chemistry Chapters for the DisulfotonRED( JohnAbbots/ KenDockter) .......................... 37 Appendix 6: Occupational/ Residential Exposure Chapter for the Disulfoton RED (Jonathan Becker) and Memorandum from Jerome Blondell to Jonathan Becker of HED (3/ 25/ 1998): Review of Disulfoton Incidence Reports (Jerome Blondell) ..... 37 LIST OF TABLES Table1: AcuteToxicityofDisulfotonTechnical .............................. 9 Table2: ToxicityProfileofDisulfotonTechnical............................. 11 Table3: EndpointsSelectedfor AcuteandChronicDietaryExposure............. 13 Table 4: Endpoints Selected for Occupational and Residential Exposure Scenarios . . . 14 Table 5: Common and Chemical Names of Identified Disulfoton Tolerance Residues . . 16 Table 6: Acute Dietary Risk Estimates (aPAD = 0. 0025 mg/ kg/ day) .............. 18 Table 7: Chronic Dietary Risk Estimates (cPAD = 0. 00013 mg/ kg/ day) ........... 19 Table 8: DWLOC Values for Total Acute Dietary Exposure at the 99.9 th percentile (DWLOC acute ) ........................................ 21 Table 9: DWLOC Values for Total Chronic Dietary Exposure (DWLOC chronic )...... 22 3 Table 10: Occupational Handler Total Exposure (dermal and inhalation) to Disulfoton for Short­ and Intermediate­ Term Exposure with Baseline, PPE or EngineeringControls( EngC) ................................... 24 Table 11: Disulfoton Intermediate­ Term Surrogate Occupational Postapplication Assessment( RangeFinder) for HighApplicationRates ............... 29 Table12: ResidentialHandlerShort­ termRisksfromDisulfotonatBaseline ........ 32 1 In this document, risk estimates are presented as a percentage of the population adjusted dose (aPAD or cPAD) and occupational/ residential risk is estimated as Margin of Exposure (MOE). Dietary exposure greater than 100 percent of the PAD is a risk of concern and MOEs less than 100 are a risk of concern for occupational/ residential and aggregate exposure (water, diet and residential). 4 1.0 EXECUTIVE SUMMARY 1 This risk assessment is being conducted on the organophosphate pesticide, disulfoton, for reregistration. Disulfoton (O, O­ diethyl S­[ 2­( ethylthio) ethyl] phosphorodithioate) is an acaricide and insecticide currently registered by Bayer Corporation for application to grains, vegetables, cotton, and other crops. Technical disulfoton contains 98.5 percent active ingredient (ai). Formulations include the emulsifiable concentrate (17.5 percent­ 85 percent ai) and the granular (0. 37 percent­ 15 percent ai). The two percent and 15 percent granular, 95 percent ready­ to­ use (RTU), and the 8 lb/ gal emulsifiable concentrate (EC) formulations are the disulfoton formulation classes registered for use on food/ feed crops. Applications are made with ground and aerial equipment, as well as hand­ held equipment. Application rates range from 0. 005 lb ai/ 1000 ft 2 to over 100 lb ai/ A. Disulfoton is registered for use on both occupational and non­ occupational use­ sites including, but not limited to, food and feed crops, nut trees, non­ bearing fruit trees, ornamental flowers, shrubs and trees, potted plants, residential rose bushes, and residential vegetable gardens. The registrant has agreed to discontinue disulfoton use on vegetable gardens. Exposure to disulfoton and its cholinesterase inhibiting metabolites occurs through exposure to residues in food and water; through mixing, loading, application, and other handling procedures; and from dislogeable residues on treated plants. Residential exposure can occur through food, water, home garden use, and flower and ornamental disulfoton application and uses. The potential problem of exposure to children from hand­ to­ mouth exposure in treated areas was shown to be below the Agency's level of concern. Introduction 2 PAD = Population Adjusted Dose = Acute or Chronic RfD FQPA Safety Factor 5 Toxicity endpoints selected for risk assessment are based on cholinesterase inhibition. Disulfoton is an organophosphate, causing cholinesterase inhibition at low dose levels and across species. No neuropathy is seen in any of the studies. Brain, plasma and erythrocyte cholinesterase inhibition all occurred at the same dose level in many, but not all, studies. Females are slightly more sensitive than males. An uncertainty factor (UF) of 100X was applied to the risk assessment to account for inter­ and intraspecies variation. The FQPA safety factor (as required by the Food Quality Protection Act of August 3, 1996) was reduced to 1X because disulfoton studies show no increased susceptibility to infants and children, and no neuropathy was seen in any study. Current reassessed tolerances are based on submitted field trial data on disulfoton, its oxygenated metabolite (demeton­ S), and the corresponding sulfoxide and sulfone metabolites. In plants, disulfoton is rapidly converted to disulfoton sulfoxide and sulfone or disulfoton oxygen analog sulfoxide and sulfone (demeton­ S sulfone). When the sulfur­ containing side chain is removed, the products are no longer cholinesterase inhibitors. The tolerance expression for disulfoton is composed of disulfoton and its five metabolites expressed as disulfoton. This risk assessment includes all supported crops and use sites listed on the current labels. The revised acute (probabilistic assessment) and chronic dietary exposure assessment represent the most highly refined dietary assessments possible with the data available. The revised assessments were based on data from the U. S. Department of Agriculture (USDA) Continuing Survey of Food Intake by Individuals, monitoring data from USDA Pesticide Data Program (PDP) and the Food and Drug Administration (FDA) monitoring program, field trial data, processing factors from the registrant, published literature, and percent crop treated information. The monitoring data showed few detections for disulfoton or its five metabolites, thus anticipated residues were estimated by one­ half­ the­ limit­ of­ detection (½ LOD) for disulfoton and its metabolites that were likely to be present for all non­ detectable residues. The acute dietary exposure is below the Agency's level of concern (< 100 percent acute Population Adjusted Dose, or aPAD 2 ). The most highly exposed groups are children one to six years old and infants less than one year, both with 9. 6 percent (at the 99.9 th percentile) of the aPAD. The remaining groups show an acute risk that ranges from 4.7 percent to 8. 8 percent of the aPAD at the 99.9 th percentile exposure. Toxicity, Dose­ Response, and the FQPA Factor Dietary Risk Assessment 6 The chronic dietary exposure is below the Agency's level of concern (< 100 percent chronic Population Adjusted Dose, or cPAD). The most highly exposed group is children one to six years old with 3. 5 percent of the cPAD. The remaining groups show a chronic dietary risk that ranges from 0.87 percent to 2. 4 percent of the cPAD. Most monitoring data for drinking water were inadequate; therefore, drinking water levels of comparison (DWLOCs) were calculated and compared with surface water concentration levels estimated from the Tier 2 PRZM/ EXAMS model, and groundwater concentration levels estimated from the SCI­ GROWmodel of disulfoton in water. Exposure to disulfoton through drinking water may be of concern when calculated DWLOCs are lower than the estimated environmental concentrations of disulfoton in water. PRZM/ EXAMS and SCI­ GROW model estimates are conservative and thus tend to over estimate concentration levels of disulfoton that may be present in ground and surface water. The limited quality assured monitoring data supported the SCIGROW modeling values for groundwater and showed that SCI­ GROW values were reasonably accurate for vulnerable areas. Modeled surface water estimates are higher than the acute DWLOCs for the highest exposed group through food (children one to six years), which indicates that disulfoton in surface water may be an acute risk of concern. Modeled groundwater estimates are lower than the acute DWLOC for the most exposed population, which indicates that disulfoton and residues in groundwater may not be of concern. For chronic exposure, surface water and groundwater estimates are higher than the chronic DWLOCs for the highest exposed group through food (children one to six years), which indicates that disulfoton and residues in surface and groundwater may be a chronic risk of concern. Endpoints used for occupational and residential assessments were based on cholinesterase inhibition seen in a dermal study for short­ term exposure (one to seven days) and an oral study for intermediate exposure (one week to several months). A 36 percent oral equivalent dermal absorption value was used for the intermediate exposure assessment. An inhalation endpoint was based on an inhalation study for both short­ term and intermediate­ term exposure. For most occupational pesticide handler scenarios exceed the Agency's level of concern. With engineering controls in place, only four of the 20 occupational scenarios showed risks that do not exceed the Agency's level of concern. Based on acute toxicity category of I, postapplication reentry intervals (REIs) are 48 hours after treatment with liquid disulfoton at 4. 0 lb ai/ A or lower rates of application. Reentry intervals, using standard values are estimated to be 28 to 36 days at higher rates of application of disulfoton. Drinking Water Assessment Occupational and Residential Risk Assessment 7 Scenarios that do not exceed the Agency's level of concern for residential handler uses are limited to ornamentals and garden use at the lowest application rates. Postapplication risks for adult homeowners were estimated to be low. Toddlers, with hand­ to­ mouth exposures in treated areas, do not exceed the Agency's level of concern. An aggregate risk assessment (food, drinking water, and residential) was not conducted for disulfoton. All of the residential exposure scenarios specified on the label exceed the Agency's level of concern (MOEs < 100) at the maximum use rate. Estimated environmental concentrations of disulfoton residues in water are above the Agency's level of concern. Any aggregation of exposure to disulfoton through residential uses and drinking water would only serve to increase the Agency's level of concern. The Agency is in the process of formulating guidance for conducting cumulative assessment. When this guidance is complete, the cumulative risk from all organophosphates will be assessed where appropriate. Some minor revisions in the tolerance expression are required for harmonization with Codex. Tolerances that are currently expressed as demeton­ S should be expressed as disulfoton. In summary, exposure to disulfoton in the diet is below the Agency's level of concern for both acute and chronic food exposure, but most occupational and residential exposures exceed the Agency's level of concern even with engineering controls (when applicable). Acute and chronic DWLOCs for surface water may be a risk of concern, and chronic DWLOC compared with the groundwater estimates may show a risk of concern. Aggregate and Cumulative Risk Assessment Codex Conclusion 8 P S S S CH 3 OC 2 H 5 H 5 C 2 O 2.0 PHYSICAL/ CHEMICAL PROPERTIES CHARACTERIZATION Disulfoton is a colorless to yellow liquid with a boiling point of 62
C at 0. 01 mm Hg, vapor pressure 1.8x10 ­4 millibars at 20
C. The vapor pressure of disulfoton is moderately high, suggesting that inhalation of disulfoton may contribute to exposure under certain circumstances. Disulfoton is soluble in water at 25 ppm at 20
C and is miscible in dichloromethane , hexane, 2propranol and toluene at 20
C. Disulfoton is an organophosphate insecticide with a molecular weight of 274.4 g/ mole. The systematic name is O, O­ diethyl S­[ 2­ ethylthio) ethyl] phosphorodithioate with a trade name of Di­ Syston (R) . The structure is presented below. Empirical Formula: C6H19O2PS3 Molecular Weight: 274.4 g/ mole CAS Registry No.: 298­ 04­ 4 Chemical No.: 032501 3.0 HAZARD CHARACTERIZATION 3.1 Hazard Profile Disulfoton is acutely toxic by the oral, dermal and inhalation routes (Table 1). Disulfoton was too toxic for guideline studies on primary eye, skin irritation and dermal sensitization to be conducted. The data requirements were waived because of the severity of the anticipated results and the most severe categories should be assumed for eye and skin irritation. The mode of action of disulfoton is inhibition of cholinesterase. In all of the toxicity studies evaluated in this hazard assessment, the LOAEL and NOAEL were established by the inhibition of cholinesterase (the basis for all regulatory endpoints). Clinical signs, such as muscle fasciculation and tremors are seen either at higher dose levels or at the LOAEL some studies. All three cholinesterases (plasma, erythrocyte and brain) are inhibited at the LOAEL in at least one study in the rat, mouse, rabbit and dog and are likely to occur across species. Slight species differences occur, but the differences may be due to normal variation and differences in the duration of the studies conducted in different species. Adult females appear to be slightly more sensitive than males. In a six­ month study in rats (MRID# 43058401), cholinesterase inhibition was seen only in females at the LOAEL. 9 Table 1: Acute Toxicity of Disulfoton Technical Guideline No. Study Type MRID #( S). Results Toxicity Category 81­ 1 Acute Oral Acc# 072293, Doc# 003958, p41 LD50 = M: 6. 2 mg/ kg; F: 1.9 mg/ kg I 81­ 2 Acute Dermal Acc# 07793, Doc# 03958, p71 & 004223, p24 LD50 = M: 15.9 mg/ kg; F: 3.6 mg/ kg I 81­ 3 Acute Inhalation Acc# 258569, Doc# 05789 LC50 =M: 0. 06mg/ L; F: 0.015 mg/ L I 81­ 4 Primary Eye Irritation Data requirement waived. Doc# 03958, p12; 004223, p14 I (assumed) 81­ 5 Primary Skin Irritation Data requirement waived. Doc# 03958, p12; 004223, p14 I (assumed) 81­ 6 Dermal Sensitization Data requirement waived. Doc# 03958, p12 Sensitizer (assumed) 81­ 7 Acute Delayed Neurotoxicity MRID# 44996401, Doc# 013957 Negative for OPIDP The cholinesterase endpoints between acute and chronic studies in rats all are approximately within a 10 fold exposure level. Longer exposure always showed cholinesterase inhibition at a lower dose level. Clinical signs occurred in test animals at the same dose level as cholinesterase inhibition in the acute neurotoxicity study, whereas in the 90­ day neurotoxicity study, cholinesterase inhibition occurred at a lower dose level. Motor activity was affected at lower dose levels in the 90­ day study than in the acute study, but no treatment related or significant neuropathology occurred either acutely or in the 90­ day studies. No definitive endocrine disruption was seen in any of the studies. Absolute testes and ovarian weights were decreased (of unknown cause) at the highest dose level and in the presence of cholinesterase inhibition and well above the NOAEL in the chronic rat study. See Section 6. 0 on Endocrine Modulation for the Agency's plans for implementation of tests on pesticides for possible endocrine affects. There is an adequate dermal absorption study in rats and an adequate 21­ day dermal study in rabbits showing cholinesterase inhibition (plasma, erythrocyte and brain). Acceptable studies in rats and mice did not demonstrate evidence of carcinogenicity. 10 Disulfoton is positive in some mutagenicity studies without activation, but negative or weakly positive with activation in most. The mutagenicity database is complete for the pre­ 1990 required three mutagenicity categories and the in vivo database support a lack of concern for the mutagenicity of disulfoton. The metabolism of disulfoton was studied in the rat. Disulfoton was found to be rapidly absorbed and excreted with over 95 percent of the administered C 14 labeled disulfoton being recovered in the urine. Approximately 90 percent of the disulfoton was excreted within 24 hours. Less than two percent was recovered from the feces. Bioaccummulation was not observed with less than 0.3 percent being recovered in tissues and less than one percent being recovered in the carcass. A major metabolite was incompletely identified, but it co­ chromatographed with 1­( ethylsulfonyl)­ 2­( methylsulfonyl) ethane, a fully oxidized form of the putative hydrolysis product. The toxic metabolites of disulfoton are disulfoton sulfoxide, disulfoton sulfone, disulfoton oxygen analog (demeton­ S), disulfoton oxygen analog sulfoxide and disulfoton oxygen analog sulfone. The Metabolism Committee determined that the residues to be regulated in plant and animal commodities are disulfoton and these five disulfoton metabolites. There is no increased susceptibility to fetuses or pups in acceptable developmental and reproductive toxicity studies in the rabbit or rat. In the study on reproduction, cholinesterase was inhibited (plasma, erythrocyte and brain) in parents at lower dose levels than in pups. Pup death occurred at the highest dose tested in the study on reproduction. The deaths were attributed to an inadequate milk supply and maternal care failure. In the developmental toxicity study in the rat, developmental toxicity occurred at higher doses than caused toxicity in dams. Developmental toxicity in the rat was seen in the form of incomplete ossification, but no developmental toxicity was seen in the rabbit at the adequate dose levels administered. No fetal or offspring sensitivity issues or neuropathology was identified in the toxicology database. The toxicity profile of disulfoton is presented in Table 2. The toxicity database for disulfoton is adequate to support reregistration. The database is of generally high quality with better than average consistency in data on the dose and treatment relationship of plasma, erythrocyte and brain cholinesterase inhibition which are the regulatory endpoints of concern. All the toxicity data used to select endpoints for regulation were acceptable guideline studies. 11 Table 2: Toxicity Profile of Disulfoton Technical Study Type MRID No. Results Acute Neurotoxicity ­ Rat 42755801 NOAEL (Clinical signs and ChE Inhibition) = 0. 25 mg/ kg/ day LOAEL (Clinical signs and ChE Inhibition) = 0. 75 mg/ kg/ day Acute Inhalation ­ Rat Acc# 258569 NOAEL (ChE Inhibition) = 0. 0005 mg/ L LOAEL (ChE Inhibition) = 0. 0018 mg/ L 21­ Day Dermal ToxicityRabbit 00162338 NOAEL (Systemic) = 1. 6 mg/ kg/ day LOAEL (Systemic) = 6.5 mg/ kg/ day NOAEL (ChE Inhibition) = 0. 4 mg/ kg/ day LOAEL (ChE Inhibition) = 1. 6 mg/ kg/ day Subacute Inhalation ­ Rat (3­ 5 day exposures) Acc# 258569 NOAEL (ChE Inhibition) = Not established LOAEL (ChE Inhibition) = 0. 0005 mg/ L Subchronic Inhalation ­ Rat 41224301 NOAEL = (ChE Inhibition) = 0. 00016 mg/ L LOAEL = (ChE Inhibition) = 0. 0014 mg/ L Subchronic Neurotoxicity ­Rat 42977401 NOAEL (Clinical signs) = 0. 071 mg/ kg/ day LOAEL (Clinical signs) = 0. 315 mg/ kg/ day (HDT) NOAEL (ChE Inhibition)= Not established. LOAEL (ChE Inhibition)= <0.071mg/ kg/ day (LDT) Subchronic­ Feeding­ Rat Data waived because an adequate chronic study was available Special 6­ Month Cholinesterase ­ Rat Non­ guideline study 43058401 NOAEL (ChE Inhibition) = 0. 03 mg/ kg/ day LOAEL (ChE Inhibition) = 0. 07 mg/ kg/ day Subchronic­ Feeding­ Dog Data waived because an adequate chronic dog study was available Chronic­ Feeding­ Dog (1­ year) 44248002 NOAEL (ChE Inhibition)= 0. 013 mg/ kg/ day LOAEL (ChE Inhibition)= 0. 094 mg/ kg/ day Chronic­ Feeding­ Dog (1­ year) 00073348 NOAEL = (ChE Inhibition) = 0. 25 mg/ kg/ day LOAEL (ChE Inhibition) = 0. 05 mg/ kg/ day Chronic Toxicity/ Carcinogenicity Rat 00146873 41850001 41850002 NOAEL (systemic) = 0. 04 mg/ kg/ day LOAEL (systemic) = 0.165 mg/ kg/ day (HDT) NOAEL (ChE Inhibition) = Not demonstrated LOAEL (ChE Inhibition) = 0. 04 mg/ kg/ day (LDT) No evidence of carcinogenicity Carcinogenicity ­ Mouse 00129456 00139598 NOAEL (ChE Inhibition) = 0. 6 mg/ kg/ day LOAEL (ChE Inhibition) = 2. 4 mg/ kg/ day (HDT) No evidence of carcinogenicity Developmental Toxicity­ Rat 00129458 Maternal: NOAEL = 0.1 mg/ kg/ day LOAEL = 0.3 mg/ kg/ day Developmental: NOAEL = 0. 3 mg/ kg/ day LOAEL = 1.0 mg/ kg/ day Table 2: Toxicity Profile of Disulfoton Technical Study Type MRID No. Results 12 Developmental Toxicity­ Rabbit 00147886 Maternal: NOAEL = 1.0 mg/ kg/ day LOAEL = 1.5 mg/ kg/ day Developmental: NOAEL= >3. 0 mg/ kg/ day LOAEL = >3. 0 mg/ kg/ day Reproductive Toxicity ­ Rat 44440801 Parental/ NOAEL = Not established Systemic: LOAEL = 0.025 mg/ kg/ day (LDT) Offspring: NOAEL = 0. 10 mg/ kg/ day LOAEL = 0.45 mg/ kg/ day (HDT) Reproductive Toxicity ­ Rat 00157511 Parental/ NOAEL = 0.04 mg/ kg/ day Systemic: LOAEL = 0.12 mg/ kg/ day Offspring: NOAEL = 0. 04 mg/ kg/ day LOAEL = 0.12 mg/ kg/ day Gene Mutation Salmonella 00028625 Non­ mutagenic (±) activation. Gene Mutation ­ HGPRT 40638401 Assumed + because tested at partially soluble conditions. Chromosomal Aberrations 43615701 Non­ mutagenic (±) activation. Sister Chromatide Exchange 40495001 Non­ mutagenic (­) activation, but (+) with activation. Sister Chromatide Exchange Acc# 072293 Non­ mutagenic (±) activation Unscheduled DNA Synthesis Acc# 028625 Mutagenic (+) activation, but non­ mutagenic (­) activation Mouse Lymphoma EPA­ 600/ 1­ 84­ 003 Mutagenic (+) activation, but non­ mutagenic (+) activation. Mouse Micronucleus EPA­ 600/ 1­ 84­ 003 Non­ mutagenic. Sister Chromatide Exchange EPA­ 600/ 1­ 84­ 003 Weakly mutagenic (­) activation, but non­ mutagenic (+) activation Table 2: Toxicity Profile of Disulfoton Technical Study Type MRID No. Results 13 Metabolism­ Rat 42565101 Greater than 90 percent of the administered radioactivity was metabolized completely and eliminated within 24 hours. About 95 percent of the radiolabel was recovered in the urine, <2 percent in the feces, <0. 3 percent in tissues and <1 percent in the carcas. No bioaccummulation was noted. Sex related differences were attributed to different metabolic rates rather than different profiles. The (toxicologically inactive) major and minor metabolites were produced by hydrolysis of oxygen metabolites. Dermal Absorption ­ Rats 43360201 Dermal absorption is considered to be 36 percent at 10 hours 3.2 Endpoint Selection Table 3 shows the acute and chronic dietary exposure endpoints. Table 4 shows the NOAELs, endpoints, and MOEs selected for residential and occupational exposure. Table 3: Endpoints Selected for Acute and Chronic Dietary Exposure Exposure Scenario Study NOAEL 1 Endpoint Acute dietary Acute neurotox/ rat (81­ 8) 0.25 mg/ kg/ day Cholinesterase inhibition and muscle fasciculation was seen in females at 0. 75 mg/ kg/ day Acute dietary PAD = 0.0025 mg/ kg (NOAEL/ 100) Chronic dietary Chronic/ Dog (83­ 1) 0.013 mg/ kg/ day Plasma, erythrocyte, brain and retinal cholinesterase inhibition was seen in females at 0.094 mg/ kg/ day Chronic dietary PAD = 0.00013 mg/ kg/ day (NOAEL/ 100) 14 Table 4: Endpoints Selected for Occupational and Residential Exposure Scenarios Exposure Scenario Study NOAEL 1 Endpoint Short­ term (dermal) 21­ day dermal/ rabbit (82­ 3) 0.4 mg/ kg/ day Plasma, erythrocyte and brain cholinesterase inhibition was seen in males and females at 1.6 mg/ kg/ day Correction for dermal absorption unnecessary (MOE necessary is 100) Intermediateterm (dermal) 6­ month oral chronic/ rat 0.03 mg/ kg/ day 2 Plasma, erythrocyte and brain cholinesterase inhibition was seen in females at 0. 7 mg/ kg/ day Correction for oral to dermal exposure necessary (MOE necessary is 100) Long­ term (dermal) Chronic oral/ dog (83­ 1) 0.013 mg/ kg/ day 2 Plasma, erythrocyte, brain and retinal cholinesterase inhibition was seen in females at 0.094 mg/ kg/ day Correction for oral to dermal exposure necessary (MOE necessary is 100) All Time Periods ShortIntermediate and Long­ term (inhalation) 90­ day inhal/ rat (82­ 4) 0.00016 mg/ L Plasma, erythrocyte and brain cholinesterase inhibition was seen in males and females at 0.0014 mg/ L Inhalation (MOE necessary is 100) 1 = No Observed Adverse Effect Level. 2 = Appropriate route­ to­ route extrapolation should be performed for these risk assessments ( i. e., oral to dermal components use absorption rates of 36 percent). 3.3 FQPA Considerations The Hazard Identification Assessment Review Committee (HIARC) recommended that the FQPA safety factor be removed for disulfoton (A Combined Report of the Hazard Identification Assessment Review Committee, 1/ 19/ 2000 and the FQPA Safety Factor Committee, 1/ 24/ 2000). The toxicity database is complete including neurotoxicity studies in rats and there is no evidence of either neurotoxicity or increased susceptibility of fetuses or offspring in prenatal and postnatal studies in rabbits or rats. The committee determined that the 1X FQPA factor is applicable for all populations. 15 4.0 EXPOSURE ASSESSMENT 4.1 Summary of Registered Uses Disulfoton is an organophosphate insecticide/ acaricide registered by Bayer Corporation under the trade name DiSyston ® . Disulfoton is registered in the United States for preplant, at­ planting, preemergence and foliar applications. Formulations include the 98.5 percent active ingredient (ai) technical product, an emulsifiable concentrate (17.5 percent to 85 percent ai), and a granular (0.37 percent to 15 percent ai). Disulfoton has been registered for use on both occupational and non­ occupational usesites Occupational use­ sites include food and feed crops, nut trees, non­ bearing fruit trees, ornamental flowers, shrubs and trees, and potted plants. Non­ occupational use­ sites include residential ornamental flowers, shrubs and trees, residential rose bushes, residential vegetable gardens (proposed for deletion), and residential potted plants. Application rates range widely from 0. 005 lb ai/ 1000 ft 2 to over 100 lb ai/ A. Disulfoton is applied with ground and air equipment as well as hand­ held equipment. 4.2 Dietary Exposure from Food The Metabolism Committee concluded that residue to be regulated in plants include parent disulfoton and five metabolite expressed as disulfoton (Table 5). In plants, disulfoton is rapidly converted to disulfoton sulfoxide and sulfone or disulfoton oxygen analog sulfoxide and sulfone (demeton­ S sulfone). When the sulfur­ containing side chain is removed, the products are no longer cholinesterase inhibitors. In ruminants and poultry, of the six metabolites of concern, only parent disulfoton was identified. The analytical methods for enforcement and data collection involve oxidation of disulfoton and its metabolites to the corresponding sulfones. It should be noted the method of analysis for USDA Pesticide Data Program (PDP) and the Food and Drug Administration (FDA) data analyzes for disulfoton and each metabolite individually where analyzed because the oxidation step is not included. The PDP included some but not all metabolites. Tolerances for disulfoton residues in food were reassessed and range from 0. 01 ppm for milk to 5. 0 ppm for oats and wheat folder. For additional details see Appendix 4. 16 Table 5: Common and Chemical Names of Identified Disulfoton Tolerance Residues I. Disulfoton IV. Disulfoton oxygen analog; Demeton­ S O, O­ diethyl S­[ 2­( ethylthio) ethyl] phosphorodithioate O, O­ diethyl S­[ 2­( ethylthio)­ ethyl] phosphorothioate II. Disulfoton sulfoxide V. Disulfoton oxygen analog sulfoxide O, O­ diethyl S­[ 2 ethylsulfinyl) ethyl] phosphorodithioate O, O­ diethyl S­[ 2­( ethylsulfinyl) ethyl phosphorothioate III. Disulfoton sulfone VI. Disulfoton oxygen analog sulfone O, O­ diethyl S­[ 2­( ethylsulfonyl) ethyl] phosphorodithioate O, O­ diethyl S­[ 2­( ethylsulfonyl ethyl] phosphorothioate 4.2.1 Acute and Chronic Dietary Exposure Methodology and Characterization The acute and chronic dietary risk assessments are performed using DEEM® software. The dietary exposure estimates are the most refined possible from the data available. For the current Tier 3 dietary risk estimates, a probabilistic model (Monte Carlo) was used for acute dietary risk and deterministic methodology utilizing average food consumption was used for chronic dietary risk. USDA's Pesticide Data Program (PDP) and the Food and Drug Administration (FDA) data were used for detectable levels of disulfoton and metabolites of concern. PDP and FDA collect residue data on large food samples (generally 5 lb or more). The data is collected in a statistically sound manner and under Good Laboratory Practices that are approved by the Agency. For the acute dietary assessment, all single serving food forms included in the disulfoton assessment, and for which monitoring data were used include asparagus, broccoli, cabbage, cauliflower, sweet corn, head lettuce, leaf lettuce, sweet peppers, potatoes, and tomatoes. Combining ½ LODs for disulfoton and its five metabolites for non­ detects may over estimate the probable levels of these residues. The ½ LOD procedure was modified to include ½ LOD for parent and those metabolites that were likely to occur (estimated from field trial and metabolism data which indicated only three of the five metabolites were likely to occur). This method yields conservative estimates of the possible residue levels, and will not underestimate these levels. For details on the use of this method to modify the use of ½ LOD for disulfoton and all five metabolites in estimating appropriate values for non­ detectable residues, see Monitoring Data, in Appendix 4. Percent Crop Treated Data 17 A quantitative usage analysis was provided by OPP's Biological and Economic Analysis Division (BEAD) based on data years 1987­ 98 (Steven M. Nako, QUA date: May 5, 1999). Data sources included USDA/ NASS (1990­ 97), California EPA, Department of Pesticide Regulation (1993­ 96), National Center for Food and Agricultural Policy (1992), and various proprietary data sources including Doane (1987­ 98), Maritz, and Mike Buckley (1994­ 97). Contribution of potential residues from crops with import tolerances was based on information provided by Bayer Corporation (MRIDs 44821701 & 44821702). As a default assumption, all imports from countries approved for disulfoton use on coffee, hops, and rice were included, and of these imports 100 percent were assumed treated with disulfoton. Additionally, only Argentina has a registration for disulfoton on hops but in the submitted analysis 100 percent of the imported hops and imported beer (from all countries) was considered as treated. The registrant's proposal for these crops is acceptable and, in the absence of more refined data, will be used in estimating residues on these crops. Food Processing Factors The registrant has included processing information in their most recent refined dietary assessments (explained and documented in MRIDs 44821701 & 44821702). These factors were based on several Bayer reports as well as published articles from the scientific literature and were used by Bayer to adjust residue values derived from field trial data. These reports have been reviewed and, where applicable, the data have been incorporated in the dietary risk assessment. 4.2.2 Acute Dietary Risk (Food) The most highly refined acute dietary risk using available data is presented below in Table 6. The highest acute dietary risk is 9. 6 percent of the aPAD at the 99.9 th percentile for children one to six years old. The acute dietary risk for the general population is seven percent of the aPAD at the 99.9 th percentile. See table 6 for the acute dietary risk for other subpopulations. An extensive sensitivity analysis has not been conducted; however, it would be expected that the critical commodities would be high consumption items that have residues on them. The succulent beans have the most delectable residues from monitoring data, although they are few and at low levels. For additional details see Appendix 4. 18 Table 6: Acute Dietary Risk Estimates (aPAD = 0.0025 mg/ kg/ day) Population 95 th percentile 99 th percentile 99. 9 th percentile Exposure % aPAD Exposure % aPAD Exposure % aPAD US pop­ All seasons 0.000031 1.2 0. 000065 2.6 0. 000176 7.0 All infants (< 1 yr) 0.000043 1.7 0. 000074 3.0 0. 000218 8.7 Children (1­ 6 yr) 0.000063 2.5 0. 000116 4.6 0. 000239 9.6 Children (7­ 12 yr) 0. 000041 1.6 0. 000076 3.0 0. 000203 8.1 Females (13+/ preg/ not nursing) 0.000019 0.76 0.000033 1.3 0. 000084 3.4 Males (20+ yr) 0. 000021 0.84 0.000046 1.8 0. 000148 5.9 Seniors (55+) 0. 000019 0.78 0.000045 1.8 0. 000184 7.4 DEEM ® (Ver 6. 78), Acute analysis disulfoton based on 1989­ 92 data. 4.2.3 Chronic Dietary Risk (Food) The estimates of chronic dietary exposures from uses of disulfoton on food and feed crops are shown in Table 7. The highest chronic food exposure was to children one to six years old at 3.5 percent of the cPAD. The chronic dietary risk for the general population is 2. 3 percent of the cPAD. For chronic dietary risk the chronic module version 6.76 of DEEM™ was used and is the most highly refined possible with the data available. Human consumption of the various commodities was estimated from the 1989 ­ 1992 USDA Continuing Surveys of Food Intake for Individuals. The chronic assessment incorporated average residues of disulfoton and its five metabolites of concern from monitoring data and field trials, adjusted for percent crop treated and for residue reduction or concentration from processing and cooking. For additional details see Appendix 4. 19 Table 7: Chronic Dietary Risk Estimates (cPAD = 0.00013 mg/ kg/ day) Population Average Exposure (mg/ kg/ day) %cPAD US population (total) 0.000003 2.3 All infants (< 1 yr) 0.000001 0.9 Children (1­ 6 yr) 0.000005 3.5 Children (7­ 12 yr) 0. 000003 2.4 Females (13­ 19 not preg or nursing) 0. 000002 1.4 Females (20+ yr not preg or nursing) 0. 000003 2.3 Females (13+ preg/ not nursing) 0. 000002 1.3 Females (13+ yr nursing) 0. 000002 1.9 Males (20+ yr) 0. 000003 2.4 Seniors (55+) 0. 000003 2.5 DEEM ® (Ver. 6.76) Chronic dietary analysis for disulfoton using 1989­ 92 data; Adjustment factor #2 used 4.3 Water Exposure (Drinking Water Sources) Potential exposure to disulfoton in drinking water was assessed using modeling and limited monitoring data. The data were provided by the Environmental Fate and Effects Division (EFED)( Memorandum from Kathryn Montague, John Jordon, James Wolf, and Mary Frankenberry to Christina Scheltema, SRRD (amended 10/ 07/ 99 from 8/ 26/ 99). The major routes of dissipation are microbial degradation in an aerobic soil and aqueous photolysis and soil photolysis. Limited data suggest that the sulfoxide and sulfone degradates are much more persistent than the parent. 4.3.1 Surface Water A Tier 2 assessment was conducted using PRZM/ EXAMS modeling based on the fate profile for disulfoton, disulfoton sulfoxide, and disulfoton sulfone, as well as maximum registered application rates. The maximum peak concentration of parent disulfoton and cholinesterase inhibiting residues was estimated at 58  g/ L and the estimated maximum mean of annual averages is 9.3  g/ L. 20 4.3.2 Groundwater The SCI­ GROW (Screening Concentrating in Groundwater) screening model was used to estimate potential groundwater concentrations for disulfoton parent and residues. At the maximum application rate, the maximum predicted disulfoton and residue groundwater concentration was 3.2  g/ L from SCI­ GROWmodels. Groundwater levels from SCI­ GROW are supported by the 2. 9  g/ L from limited monitoring data (see Section 4. 4. 3). 4.3.3 Monitoring Data Surface water monitoring data collected by the USGS as part of the National Water Quality Assessment (NAWQA) program was also considered. Disulfoton and residues were found in 10 out of 2700 surface water samples. Maximum concentrations were 0.002  g/ L and 0.007­ 0.041  g/ L in integrated streams/ agricultural wells and urban/ agricultural streams, respectively. There were no reported detections in about 2200 groundwater samples. EPA's Pesticides in Groundwater Data Base (GWDB) (EPA 732­ 12­ 92­ 0001, 1992) and EPA's STORET data was also reviewed. EPA's GWDB showed no detects in 2430 wells from 11 states (limit of detection was 0. 01 to 6. 0  g/ L). However, the GWDB data showed that disulfoton was detected in six of 12 wells sampled in Virginia (0.04 to 2.9  g/ L) and in14 of26 wells( 4. 0to100  g/ L) sampled in Wisconsin. The data from Wisconsin was not quantity assured. The data from Virginia and Wisconsin wells show the potential contamination of wells in vulnerable areas and support the SCI­ GROW modeling data. 4.3.4 DWLOCs for Acute and Chronic Exposure The Drinking Water Level of Comparison (DWLOC) is the concentration of a pesticide in drinking water that is acceptable as a theoretical upper limit, in light of total aggregate exposure to the pesticide from food, water, and residential sources. DWLOCs have been calculated for acute dietary and chronic dietary exposure. For assessing human health risk, DWLOCs are compared to estimated environmental concentrations (EECs). When DWLOCs are greater than the EECs, the aggregate risk from food, water, and residential (if applicable) exposures is considered to be less than the Agency's level of concern. 21 4.3.4.1 Acute DWLOCs The acute DWLOC values are shown in Table 8 below. The highest acutely exposed groups from food are children one to six years old and non­ nursing infants less than one year old. The acute drinking water estimated concentration for surface water (58  g/ L) was greater than DWLOC acute for children one to six years and infants less than one year (23  g/ L). This indicates that acute exposure to disulfoton and residues in surface water may be a risk concern. Table 8: DWLOC Values for Total Acute Dietary Exposure at the 99.9 th percentile (DWLOC acute ) Population Acute PAD (mg/ kg/ day) Food Exposure (mg/ kg/ day) Max. Water Exposure (mg/ kg/ day) DWLOC acute (
g/ L) PRZM/ EXAMS (
g/ L a ) SCI­ GROW (
g/ L) US population 0. 00250 0.000176 0.00232 81 58 3.2 Infants <1 yr/ non nursing 0.00250 0.000237 0.00226 23 58 3.2 Children 1­ 6 yr 0.00250 0.000239 0.00226 23 58 3.2 Female (13+ yr/ nursing) 0.00250 0.000117 0.00238 70 58 3.2 Seniors (55+ yr) 0. 00250 0.000184 0.00232 81 58 3.2 a The peak water levels of 58
g (disulfoton and cholinesterase inhibiting residues)/ L from Tier 2 PRZMZ3/ EXAMS (1­ in­ 10 year values) model, page 15, Table 3b of the memorandum cited in section 4. 4). The default body weights and water consumption values used to calculate DWLOCs are as follows: 70 kg/ 2L (adult male), 60 kg/ 2L (adult female), and 10 kg/ 1L (children/ infants). According to the August 1, 1999 Updated Interim Guidance for Incorporating Water Exposure into Aggregate Risk Assessments, the following formulas were used to calculate the acute DWLOCs. DWLOC acute (ug / L) day water exposure (mg / kg / day) body weight (kg) Water consumption (L) 10 3 (mg / ug) = One × × Where; One ­ day water exposure (mg / kg / day) Acute foodexposure (mg / kg / day)] = [aPAD 22 4.3.4.2 Chronic DWLOCs The chronic DWLOC values are shown in Table 9. The chronic drinking water estimated concentration for surface water (9.3  g/ L) exceeds the DWLOCchronic (1. 2 to 4.4  g/ L) for all population subgroups. The chronic drinking water estimated concentration for groundwater (3.2  g/ L) exceeds the DWLOCchronic for children one to six years and infants less than one year. This indicates the chronic exposure to disulfoton and residues in drinking water may be a risk of concern. Table 9: DWLOC Values for Total Chronic Dietary Exposure (DWLOC chronic ) Population Chronic PAD (mg/ kg/ day) Food Exposure (mg/ kg/ day) Max. Water Exposure (mg/ kg/ day) DWLOC chronic (
g/ L) PRZM/ EXAMS (
g/ L a ) SCI GROW (
g/ L) cPAD 0.000130 0 0. 000130 4.5 9. 3 3.2 US Population 0.000130 0.000003 0.000127 4.4 9. 3 3.2 Infants <1 yr 0. 000130 0.000001 0.000129 1.3 9. 3 3.2 Children 1­ 6 yr 0.000130 0.000005 0.000125 1.2 9. 3 3.2 Female (13+ yr)/ nursing 0.000130 0.000002 0.000128 3.8 9. 3 3.2 a The maximum mean of annual average concentration 9. 3
g (disulfoton and cholinesterase inhibiting residues)/ L from PRZM/ EXAMs model, tier 2 water assessment , page 15, Table 3b of the memorandum cited in section 4. 4. Chronic DWLOCs are calculated from chronic dietary (food) exposure and default body weights and default water consumption. According to the August 1, 1999 Updated Interim Guidance for Incorporating Water Exposure into Aggregate Risk Assessments, the following formulas were used to calculate the chronic DWLOCs. DWLOC chronic ug L Chronic water mg kg day body weight kg Water consumption L (/) (//) () () (mg / ug) = × × exposure 10 3 Where; Chronic water consumption mg kg day cPAD Chronic food mg kg day (//) [(//)] = exposure 23 4.4 Occupational/ Residential Exposure An occupational exposure assessment is required for an active ingredient if (1) certain toxicological criteria are triggered and (2) if there is potential exposure to handlers (mixers, loaders, applicators, etc.) during use or to persons entering treated sites after application is complete. Disulfoton meets both criteria. Based on toxicological NOAELs and potential exposure and uses, the Agency has conducted exposure and risk assessments for occupational/ residential handlers and postapplication workers. The margin of exposure (MOE), calculated for each occupational exposure scenario, is inclusive of total exposure (dermal and inhalation) and is calculated as MOE = 1/[( 1/ MOEdermal )+( 1/ MOEinhalation )]. 4.4.1 Assumptions for Occupational Handler Exposure An exposure assessment for each exposure scenario is developed where appropriate data are available, using the Pesticide Handlers Exposure Database (PHED) Version 1. 1. PHED was designed by a task force of representatives from U. S. EPA, Health Canada, the California Department of Pesticide Regulation and member companies of the American Crop Protection Association. PHED is a software system consisting of two parts— a database of measured exposure values for workers involved in handling of pesticides under actual field conditions and a set of computer algorithms used to subset and statistically summarize the selected data. Currently, the database contains over 1, 700 monitored individuals (i. e., replicates). Users select criteria to subset the PHED database to reflect the exposure scenario being evaluated. The subsetting algorithms in PHED are based on the central assumption that the magnitude of the handler exposures to pesticides are primarily a function of activity (e. g., mixing/ loading, applying), formulation type (e. g., liquids, wettable powders, granulars), application method (e. g., aerial, groundboom), and clothing scenarios (e. g., gloves, double layer clothing). While data from PHED provide the best available information on handler exposures, it should be noted that some aspects of the included studies (e. g., duration, acres treated, pounds of active ingredient handled) may not accurately represent labeled uses in all cases. HED has developed a series of tables of standard unit exposure values for many occupational scenarios that can be utilized to ensure consistency in exposure assessments. The Revised Occupational and Residential Exposure Assessment, Appendix 6, summarizes the caveats and parameters specific to the surrogate data used for each scenario and corresponding exposure/ risk assessment for disulfoton. Table 10 shows the range of MOEs for combined dermal and inhalation exposure. The range of the MOE in each scenario in Table 10 is the result of the different disulfoton label use rates possible by the handler. The highest MOE and the lowest MOE in Table 10, respectively represent the lowest and highest labeled use rate for that scenario. 24 Table 10: Occupational Handler Total Exposure (dermal and inhalation) to Disulfoton for Short­ and Intermediate­ Term Exposure with Baseline, PPE or Engineering Controls (EngC) NOTE: An MOE< 100 exceeds Agency's Level of Concern. See Appendix 6 for additional detail about exposure and MOEs Exposure Scenario (Scenario#) Short­ Term Exposure MOE Intermediate­ Term Exposure MOE Baseline PPE EngC Baseline PPE EngC Mixer/ Loader Risk Mixing/ Loading Liquid Formulations (Emulsifiable Concentrates) for Aerial/ Chemigation Application (1a) 0.009­ 0.06 1.4­ 8.4 2. 9­ 17 0. 002­ 0.01 0.3­ 1.9 0.6­ 3.8 Mixing/ Loading Liquid Formulations (Emulsifiable Concentrates) for Ground­ boom Application (1b) 0.03­ 0.2 4. 6­ 37 9. 4­ 75 0. 006­ 0.05 1.0­ 8.4 2. 1­ 17 Mixing/ Loading Liquid Formulations (Emulsifiable Concentrates) for Orchard Airblast Sprayer Application (1c) 0.08 12 25 0.02 2.8 5. 6 Loading Granulars for Aerial Application (2a) 1.7­ 4.5 6. 2­ 17 85­ 230 0.7­ 1.9 2. 1­ 5.5 36­ 95 Loading Granulars for Drawn Spreader Application (2b) 1.9 200 6.9­ 200+ 93­ 1000 0.8­ 84 2.3­ 240 39­ 440 Applicator Risk Applying Sprays with a Fixed­ Wing Aircraft (3) No data See EC No data See EngC 14­ 29 No data See EngC No data See EC 3.3­ 6.5 Applying Granulars with a Fixed Wing Aircraft (4) No data See EngC No data See EngC 3.0­ 8.0 No data See EngC No data See EngC 2.0­ 5.4 Applying Sprays with a Helicopter (5) No data See EngC No data See EngC 42­ 84 No data See EngC No data See EngC 8.8­ 18 Applying Granulars with a Helicopter (6) No data No data No data No data No data No data Table 10: Occupational Handler Total Exposure (dermal and inhalation) to Disulfoton for Short­ and Intermediate­ Term Exposure with Baseline, PPE or Engineering Controls (EngC) NOTE: An MOE< 100 exceeds Agency's Level of Concern. See Appendix 6 for additional detail about exposure and MOEs Exposure Scenario (Scenario#) Short­ Term Exposure MOE Intermediate­ Term Exposure MOE Baseline PPE EngC Baseline PPE EngC 25 Applying Sprays with a Groundboom (7) 4.3­ 34 7.1­ 57 16­ 130 1.2­ 9.5 1. 6­ 13 3. 6­ 29 Applying Sprays to Orchards with an Airblast (8) 0.6 1. 0 1.6 0. 1 0.2 0. 4 Applying Granulars with a TractorDrawn Spreader (9) 2.1­ 230 6.9­ 77 11­ 120 0.8­ 80 2.0­ 210 3.6­ 41 Mixer/ Loader/ Applicator Risk Loading/ Applying Granulars Using a Belly Grinder (10) 0.3­ 1.3 0. 2­ 0.8 NA 0.07­ 0.3 0. 04­ 0.2 NA Loading/ Applying Granulars with a Push­ Type Granular Spreader (11) 0.05­ 4.7 0. 2­ 19 NA 0. 01­ 1.0 0. 04­ 4.0 NA Loading/ Applying Granulars by Hand, witha Spoon, ShakerCan, or a Measuring Scoop (12) 1.5 3. 8 NA 0.3 0. 8 NA Applying Ready­ to­ Use Liquid as a Seed Treatment (13) No data No data No data No data No data No data Flagger Risk Flagging Aerial Spray Applications (14) 5.7­ 11 7.5­ 15 15­ 30 1.4­ 2.9 1. 6­ 3.3 3.3­ 6.6 Flagging Aerial Granular Applications (15) 9.7­ 26 21­ 55 9.9­ 26 2.7­ 7.2 5. 0­ 16 3. 3­ 8.9 26 Handler exposure assessments are completed by EPA using a baseline exposure scenario and, if required, increasing levels of risk mitigation. Progressively more methods of handler protection beyond baseline are added to achieve an appropriate margin of exposure (MOE), such as Personal Protective Equipment (PPE) and engineering controls (EngC). Adequate worker protection was not always achieved by any type of protection. The baseline scenarios generally represents a handler wearing long pants, a long­ sleeved shirt, and no chemical­ resistant gloves. PPE controls include, but are not limited to chemical resistant gloves, eye protection, dust /mist protection or respirator and extra clothing. EngC include closed systems (loading and packaging and/ or closed tractor cabs or cockpits) and other means. 4.4.2 Occupational Handler Exposure and Characterization The Agency has identified 15 different major exposure scenarios during mixing, loading and applying disulfoton products to agricultural crops and non­ agricultural sites. The accepted range of application equipment and methods are covered in Appendix 6, in addition to the duration of handler exposure. The duration of exposure is covered by short­ term (one day to one week), and intermediate­ term (one week to several months) exposure scenarios. Disulfoton products are typically applied one to three times per season and at 20 to 42 day intervals. The major routes of exposure to handlers are dermal and inhalation. The margins of exposure (MOE) are the ratio of the NOAELs to the exposure. MOEs are calculated for short­ term and intermediate­ term dermal and inhalation exposure and presented in Table 10 as combined MOEs for dermal and inhalation. Shortterm and intermediate­ term endpoints are presented in Section 3. 2. There were no long­ term occupational exposure scenarios. (See Appendix 6 for additional detail.) 4.4.3 Occupational Handler Risks of Concern The acceptable occupational scenarios (MOE> 100) given below are for short­ term and intermediate­ term exposure each with baseline and PPE protection and engineering controls in place. Most occupational scenarios exceed the Agency's level of concern (MOE< 100). Of the 18 short­ term and intermediate­ term exposure scenarios (dermal and inhalation combined) listed in Table 10, 10 show marginally low MOEs between 70 and 100. For individual dermal MOEs and inhalation MOEs see Appendix 6. All occupational scenarios exceed the Agency's level of concern, except those listed below. 27 Calculations indicate that none of the total short­ term MOEs are greater than 100 for baseline protection exposure scenarios except the following:
(2b) loading granulars with a tractor­ drawn spreader to nut (pecan) trees assuming an application rate of 3 lb ai/ A, applied to 2 acres per day.
(9) applying granulars with a tractor­ drawn spreader to nut (pecan) trees assuming an application rate of 3 lb ai/ A, applied to 2 acres per day. Calculations indicate that none of the total intermediate­ term MOEs are greater than 100 for baseline protection exposure scenarios. Calculations indicate that none of the remaining total short­ term MOEs are greater than 100 with additional PPE. Calculations indicate that none of the total intermediate ­term MOEs are greater than 100 with additional PPE except the following:
(2b) loading granulars with a tractor­ drawn spreader to nut (pecan) trees assuming an application rate of 3 lb ai/ A, applied to 2 acres per day.
(9) applying granulars with a tractor­ drawn spreader to nut (pecan) trees assuming an application rate of 3 lb ai/ A, applied to 2 acres per day. Calculations indicate that none of the total short­ term MOEs are greater than 100 for scenarios with engineering controls in place except the following:
(2a) loading granulars for aerial application using a 1. 0 lb ai/ A or less application rate.
(2b) loading granulars for tractor­ drawn spreader application to agricultural crops at application rates of 4 lb ai/ A or less. MOEs are greater than 100 also for loading of granulars for application to non­ bearing fruit trees and to flowers and groundcovers using a tractor­ drawn spreader.
(7) applying with a groundboom to agricultural crops using an application rate of 0. 5 lb ai/ A. 28
(9) applying granulars with a tractor­ drawn spreader to agricultural crops at 0. 75 lb ai/ A and to flowers and groundcover using an application rate of 28.6 lb ai/ A. Calculations indicate that none of the total intermediate­ term MOEs are greater than 100 for scenarios with engineering controls in place except the following:
(2b) loading granulars for tractor­ drawn spreader application to agricultural crops at application rate of 1 lb ai/ A or less. MOEs are greater than 100 also for loading of granulars for application to non­ bearing fruit trees and to flowers and groundcovers using a tractor­ drawn spreader. 4.4.4 Data Gaps As noted below, several of the exposure scenarios could not be assessed due to lack of PHED surrogate data. Data gaps exist for the following scenario:
(6) ­ no PHED data exist for applying granulars from helicopters.
(16) ­ no PHED data exist for applying ready­ to­ use liquid as a seed treatment. 4.4.5 Data Quality and Confidence in Assessment Several issues must be considered when interpreting the occupational exposure risk assessment. Confidence in the exposure data is also listed in Appendix 6, as low (L), medium (M) or high (H). These include:
Several handler assessments were completed using "low quality" PHED data due to the lack of a more acceptable data set.
Several generic protection factors were used to calculate handler exposures. These protection factors have not been completely evaluated and accepted by HED.
Factors used to calculate daily exposures to handlers (e. g., acres treated per day and gallons of liquid applied) are based on the best professional judgement, due to a lack of pertinent use data. 29 4.4.6 Postapplication Exposure Postapplication exposure potential occurs to individuals entering treated areas for harvesting nut trees (pecans); harvesting low­ growing field crops; weeding and scouting and other non­ harvesting activities associated with low­ growing crops; and transplanting, harvesting and pruning ornamentals. EPA estimates that a 48­ hour reentry interval (REI), based on the acute toxicity category (I), and is adequate to protect field workers when 4.0 lb ai/ A or less has been applied as a disulfoton spray or granules to the field. For use rates that exceed 4.0 lb ai /A, minimum reentry times of 28 to 36 days are estimated using standard values (Table 11). The assumptions made would be expected to bracket the reentry exposure levels from disulfoton used on these crops. This consideration is based on the following: (1) Use of high rates directly on soil and that often soil incorporated (either mechanically or by watering in) occurs and that high application rates may be rarely used and (2) the use of a residue fraction that is retained on the foliage and available for transfer is likely to be substantially less than the 20 percent used. Additional data are required to further refine the post application exposure assessment. Based on these activities, four representative scenarios were evaluated using surrogate dislodgeable foliar residue data and assumptions about transfer of residues to skin. The surrogate assessments presented in Table 11 are based on the applications rates on disulfoton labels that are recommended for field crops, nut trees and ornamentals. Additional details, default assumptions and formulas for the calculations for the dislodgeable foliar residues and reentry times are presented in Appendix 6. Table 11: Disulfoton Intermediate­ Term Surrogate Occupational Postapplication Assessment (Range Finder) for high Application Rates Application Rate (lb ai /A) DAT a DFR (
g/ cm 2 ) b Dermal Dose (mg/ kg/ day) MOE 8 28 0. 006 0.0002 130 28.6 32 0. 006 0.0003 110 102 36 0.0007 0.0003 100 a DAT is "days after treatment." b Initial DFR = Application rate x Conversion factor (lb ai/ A = 11. 209
g/ cm 2 ) x fraction of initial ai retained on foliage. 30 4.4.7 Human Incidence Information Human incidence data contained in a memorandum from Jerome Blondell to Jonathan Becker of HED (3/ 25/ 1998), Review of Disulfoton Incidence Reports, show that disulfoton was 11 th among the 28 pesticides reported (1982­ 1989) with the highest incidence rates and had the highest ratio for cases when the pesticide was considered the primary cause of poisoning of field workers per 1000 applications. Disulfoton ranked third on percentage of occupational Poison Control Center cases requiring hospitalization and fourth among these 28 pesticides studied on percentage of occupational cases with life­ threatening symptoms. Death (including suicides and possible homicides) confounded by misuse is known to infrequently occur; however, no other permanent disability has been adequately documented. The report does not indicate the frequency or proportion of incidences related to morbidity, to labeled uses, or misuse. 4.5 Residential Exposure 4.5.1 Handler Disulfoton is applied one to three times per season and thus individual handlers would mostly be exposed short­ term. Short­ term exposure scenarios were used to calculated anticipated residential exposure (Table 12). Although short­ term exposure is defined as one day to one week, the dermal and inhalation toxicity data used in the calculations covers up to three weeks of daily exposure and is considered a conservative estimate of residential exposure. An MOE of 100 or greater is below the Agency's level of concern for residential exposure. Exposure to granular formulations were evaluated, since only granular formulations are recommended for residential use. The residential risk was shown to range from MOEs of 0. 002 to 1,900 (Table 12). Only two types of activities had MOEs below the Agency's level of concern for the lowest application rates only, and these were: (1) loading /applying granulars with a push type spreader to flower gardens at the lower rates of 0.005 lb ai/ 1, 000 ft 2 (MOE= 1,900), and (2) using the same type of equipment at the lowest rate of 0.00032 lb ai/ 4 ft shrub (MOE= 1,200). Two other activities show marginally low MOEs. These were (1) loading /applying granulars with a push type spreader to flower gardens at the lower rates of 0.1 lb ai/ 1,000 ft 2 (MOE= 93), and loading and applying granulars with a push type spreader at the labeled use rate of 0. 00188 lb ai/ bush to 50 rose bushes (MOE= 99). All other residential activities showed MOEs ranging from 0. 002 to 37 (Table 12). Table 12 lists MOEs for dermal and inhalation exposure combined. For individual dermal MOEs and inhalation MOEs see Appendix 6. The anticipated residential use patterns and current labeling indicate several major 31 exposure scenarios based on the types of equipment that potentially can be used to make disulfoton applications. These scenarios include: (1) loading/ applying granulars with a belly grinder; (2) loading/ applying granulars with a push type spreader; (3) loading/ applying granulars with a spoon, shaker can, measuring scoop, or by hand; (4) application of insecticidal spikes. 4.5.2 Residential Handler Exposure Scenarios­ Data and Assumptions Residential handler exposure assessments were completed by HED using a baseline exposure scenario. PHED values used to estimate daily unit exposure were taken from Standard Operating Procedures (SOPs) for Residential Exposure Assessments, document dated December 1997. The caveats and parameters specific to surrogate data used for each scenario and corresponding exposure/ risk assessment are detailed in Appendix 6. Data Quality The quality of the data used in the residential and non­ occupational risk assessment is ranked of low confidence category for push type granular spreaders. Factors used to calculate daily exposures to handlers (e. g., square footage treated per day, number of pots treated per day and number of tree or shrubs treated per day) are best professional judgement due to a lack of pertinent data. Data Gaps No satisfactory data exists for applying insecticidal spikes to roses or ornamental shrubs and trees. 32 Table 12: Residential Handler Short­ term Risks from Disulfoton at Baseline Exposure Scenario (Scenario #) Crop Type or Target a Amount Handled Per Day b Application Rate Baseline Total Short­ Term MOE c Mixer/ Loader/ Applicator Risks Loading/ Applying Granulars with a Belly Grinder (1) Flower/ Veg Gardens (pre­ planting) 10,000 ft. 2 0.2 lb ai/ 1000 ft 2 0.1 0.1 lb ai/ 1000 ft 2 0.3 Loading/ Applying Granulars with a Push Type Spreader (2) Roses 50 bushes 0. 00188 lb ai/ bush 99 Vegetable Gardens 10,000 ft. 2 0.1125 lb ai/ 1, 000 ft 2 h 8.2 0.0313 lb ai/ 1, 000 ft 2 h 30 Flower Gardens 1,000 ft. 2 0.3 lb ai/ 1, 000 ft 2 31 0.1 lb ai/ 1, 000 ft 2 93 0.005 lb ai/ 1, 000 ft 2 1,900 Ornamental Shrubs/ Small Trees 25 shrubs 1.32 lb ai/ 4 ft. shrub 0.3 0.01 lb ai/ 4 ft. shrub 37 0.00032 lb ai/ 4 ft. shrub 1,200 Loading/ Applying Granulars with a Spoon, Shaker Can, Measuring Scoop, or by Hand (3) Roses 50 bushes 0. 00188 lb ai/ bush 0. 7 Vegetable Gardens 10,000 ft. 2 0.1125 lb ai/ 1, 000 ft 2 h 0.06 0.0313 lb ai/ 1, 000 ft 2 h 0.2 Flower Gardens 1,000 ft. 2 0.3 lb ai/ 1, 000 ft 2 0.2 0.1 lb ai/ 1, 000 ft 2 0.6 0.005 lb ai/ 1, 000 ft 2 13 1.32 lb ai/ 4 ft. shrub 0.002 Ornamental Shrubs/ Small Trees 25 shrubs 0.01 lb ai/ 4 ft. shrub 0.3 0.00032 lb ai/ 4 ft. shrub 8.1 Potted Plants 20 pots 0. 00011 lb ai/ 6" pot 29 Table 12: Residential Handler Short­ term Risks from Disulfoton at Baseline Exposure Scenario (Scenario #) Crop Type or Target a Amount Handled Per Day b Application Rate Baseline Total Short­ Term MOE c 33 Application of Insecticidal Spikes (4) Roses/ Trees No Data No Data No Data a Crop Type or Target provides a general description of the intended use of various products containing disulfoton. Separate categories are presented because of the distinct differences in application rates and acres treated. b Amount Handled Per Day values are from default estimates of square footage or number of pots treated a single day for each exposure scenario of concern. c Total Short­ term MOE = 1/ [( 1/ Short­ term Dermal MOE) + (1/ Short­ term Inhalation MOE)]. 4.5.3 Postapplication Residential Exposure and Risk Potential postapplication exposure from residential use of the granular product can occur during transplanting garden or house plants, and weeding treated flowers, ornamental shrubs, and trees. Potential exposure can occur from non­ harvest activities such as weeding home vegetables, and from incidental soil ingestion by toddlers (hand­ to­ mouth exposure). The Agency has no data upon which to assess postapplication contact with treated soil through activities such as weeding, hoeing, and transplanting home ornamentals, vegetable crops, and house plants. However, postapplication risks for adult homeowners were estimated to be low. Exposure to toddlers was assessed using surrogate data. Exposure to toddlers (hand­ to­ mouth) in treated vegetable and flower gardens at the maximum application rates for these scenarios show MOEs of 230 and 610, respectively. Lower rates of application would show even higher MOEs. No data were available to assess exposure to toddlers (hand­ to­ mouth) for shrubs and small tree areas treated with disulfoton by residential handlers. In calculating postapplication toddler exposure, the intermediate­ term NOAEL of 0.03 mg/ kg/ day was used rather than short­ term NOAEL of 0.4 mg/ kg/ day because some reentry activity was considered to be longer than one to seven days and to be conservative. The MOE for toddlers ingesting soil at vegetable and flower garden application sites (at the lowest application rate) showed an acceptable MOE greater than 100. 3 Since the PRZM/ EXAMS model estimates are greater than the SCI­ GROW model estimates, DWLOCs are compared to the PRZM/ EXAMS estimates only. 34 4.5.4 Potential Spray Drift This assessment reflects the Agency's current approaches for completing residential exposure assessments based on the guidance provided in the Draft: Series 875­ Occupational and Residential Exposure Test Guidelines, Group BPostapplication Exposure Monitoring Test Guidelines (7/ 24/ 97 Version), the Draft: Standard Operating Procedures (SOPs) for Residential Exposure Assessment (12/ 11/ 97 Version), andtheOverview of Issues Related to the Standard Operating Procedures for Residential Exposure Assessment presented at the September 1999 meeting of the FIFRA Scientific Advisory Panel (SAP). The Agency is, however, currently in the process of revising its guidance for completing these types of assessments and expanding the scope of the residential exposure assessments by developing guidance for characterizing exposures from other sources already not included such as from spray drift, residential residue track­ in, exposures to farm worker children, and exposures to children in schools. Modifications to this assessment for disulfoton shall be incorporated as updated guidance becomes available and it is feasible from a regulatory perspective. 5.0 AGGREGATE RISK (FOOD, WATER AND RESIDENTIAL) The Food Quality Protection Act amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA, Section 408( b)( 2)( A)( ii)) require for establishing a pesticide tolerance "that there is reasonable certainty that no harm will result from aggregate exposure to pesticide chemical residue, including all anticipated dietary exposures and other exposures for which there is reliable information." Aggregate exposure will typically include exposures from food, drinking water, and residential uses of a pesticide. The aggregate risk estimate to disulfoton has addressed exposure from dietary (food) sources, drinking water, and residential uses. Acute and chronic dietary food risks are below the Agency's level of concern (< 100 percent aPAD/ cPAD). All of the residential use scenarios specified on the label exceed the Agency's level of concern (i. e., MOE< 100) at the maximum application rate, except for roses which are at the level of concern/ no concern (MOE= 99). PRZM/ EXAMS estimates 3 of exposure to disulfoton in surface water exceed the Agency's level of concern (i. e., DWLOCs< EECs). Therefore, any aggregation of exposure from residential uses and drinking water with food exposure would only further increase the risk even higher than the Agency's level of concern. 35 6.0 ENDOCRINE MODULATION The Food Quality Protection Act requires that EPA develop a screening program to determine whether certain substances (including all pesticides and inerts) "may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect...." EPA has been working with interested stakeholders, including other government agencies, public interest groups, industry and research scientists to develop a screening and testing program as well as a priority setting scheme to implement this program. The Agency's proposed Endocrine Disrupter Screening Program was published in the Federal Register of December 28, 1998 (6 3 FR 71541). The Program uses a tiered approach and anticipates issuing a Priority List of chemicals and mixtures for Tier 1 screening in the year 2000. As the Agency proceeds with implementation of this program, further testing of disulfoton and its end­ use products for endocrine effects may be required. 7.0 CUMULATIVE EXPOSURE AND RISK It has been determined that organophosphates (OPs) share a common mechanism of inhibiting cholinesterase. As required by FQPA, cumulative assessment will need to be conducted to evaluate the risk from food, water and non­ occupational exposure resulting from all uses of organophosphates. The Agency is in the process of formulating guidance for conducting cumulative risk assessments. When the guidance is finalized, disulfoton and other ChE­ inhibiting compounds (carbamates and organophosphates) will be revisited to assess the cumulative effects of exposure to multiple cholinesterase inhibiting compounds. 36 8.0 REQUIRED DATA The only toxicity study required is from a general data­ call­ in for a developmental neurotoxicity study (Guideline# 870.6300), for which disulfoton was included. There are requirements for product chemistry and several for tolerance assessments and recommendations for tolerance revocation (See the Appendix 5: Residue Chemistry Considerations for the Disulfoton RED). Data needs for Product Chemistry:
Guideline #830.1750 for EPA Reg. No. 3125­ 183
Guideline #830.1800 for EPA Reg. No. 3125­ 183
Guideline #830.7050 for EPA Reg. No. 3125­ 183
Guideline #830.1800 for EPA Reg. No. 3125­ 158
Guideline #830.1800 for EPA Reg. No. 3125­ 128 Additional data needs for residue chemistry are listed in Appendix 5. Data needs for Occupational Assessment: Occupational exposure data is necessary for applying granulars from helicopters and for applying ready­ to­ use liquid as a seed treatment because no PHED data exist for these scenarios. In addition, the Agency has no data on exposure from the use of disulfoton spikes for tree treatment. 9.0 CODEX The Codex MRLs are expressed in terms of the sum of disulfoton, demeton­ S, and their sulfoxides and sulfones expressed as disulfoton. Some US tolerance are still expressed in terms of demeton­ S. However, since the molecular weight of disulfoton is only six percent lower than demeton­ S, the difference is small. Codex MRLs and the U. S. tolerances will be compatible when the U. S. tolerance expression is revised to include disulfoton, its oxygen analog, and their sulfoxides and sulfones, calculated as disulfoton. 37 10.0 APPENDICES Appendix 1: Toxicology Chapter for the Disulfoton RED (David G. Anderson) Appendix 2: The Hazard Identification Assessment Review Committee Report for Disulfoton (Revisit) (David G. Anderson). Appendix 3: The FQPA Safety Factor Committee Report on Disulfoton (Brenda Tarplee). Appendix 4: The Revised Disulfoton: Acute and Chronic Dietary Risk Assessment (Includes MRID # 44821701 & 44821702, Chem. No. 032501; William O. Smith) Appendix 5: Product Chemistry and Residue Chemistry Chapters for the Disulfoton RED (John Abbots/ Ken Dockter) Appendix 6: Occupational/ Residential Exposure Chapter for the Disulfoton RED (Jonathan Becker) and Memorandum from Jerome Blondell to Jonathan Becker of HED (3/ 25/ 1998): Review of Disulfoton Incidence Reports (Jerome Blondell)

epa

2024-06-07T20:31:41.768438

regulations

EPA-HQ-OPP-2002-0055-0025

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Memorandum SUBJECT: Analysis of Disulfoton Use on Fraser Fir Christmas Trees in Western North Carolina. FROM: Colwell A. Cook, Entomologist Michael K. Hennessey, Entomologist Herbicide and Insecticide Branch Biological and Economic Analysis Division THRU: Arnet Jones, Chief Herbicide and Insecticide Branch Biological and Economic Analysis Division TO: Christina Scheltema, Chemical Review Manager Betty Shackelford, Branch Chief Reregistration Branch 3 Special Review and Reregistration Division DATE OF PEER REVIEW: July 3, 2002 Introduction The Special Review and Reregistration Division (SRRD) has requested that the following documents, originally prepared by Michael K. Hennessey and incorporated below, be reviewed prior to their being placed in the docket and on the web. These documents were originally written to answer if the organophosphate, disulfoton, was critical to the Fraser fir Christmas tree industry in western North Carolina. BEAD has reviewed the documents and has determined that they reflect the state of knowledge for the time in which they were written, July 2000. BEAD feels compelled to mention that several of the alternatives listed in the documents are currently under review for reregistration and some chemicals are still in the registration pipeline and should not be considered as alternatives. The following are Mike's documents submitted to SRRD on July 5, 2000. 2 Site: Fraser Fir Christmas Trees This analysis focuses on the level of need for OPs and alternatives for Fraser firs. All Fraser firs are grown in the mountainous areas of North Carolina where they are the major agricultural commodity. They are perennial with a 6­ 10 year crop cycle. In 1996, 34 million trees were grown on 24,000 acres by 1,600 growers. Over 66% of the growers had <10 acres. About 10­ 20% of the trees are harvested annually around Christmastime. Seventy­ five percent of the harvest is for the wholesale market and 25% is for the retail, choose­ and­ cut market. The value for 1996 was $78 million and for 1999 was $122 million. Trees for harvest are graded either by USDA or according to the NC Christmas Tree Association standards. Fraser firs represented 27% of the US­ grown Christmas tree market in 1999. Commercial Christmas trees of other varieties are mainly grown in OR, MI, WA, OH, and WI. Six pests are of concern to growers. OPs are critically needed for four of the pests. Crop loss comes mainly from cosmetic damage to foliage visible in the last year or two before harvest or tree death (balsam wooly adelgid). Before the last two years, trees can usually compensate for foliage loss. Large trees (6­ 7 ft tall) are most valuable. Choice of pesticide for a given pest depends upon timing, row spacing, land slope, size of trees, and acreage. Generally, pesticides applied foliarly on small trees may not be suitable for large trees after canopies are closed. Small acreage (because of cost) and acreage planted without tractor rows are not generally amenable to foliar spraying that requires access by truck or tractor. Because of mountainous terrain, aerial spraying is not generally done. Balsam twig aphid and spruce spider mite are widespread and perennial pests. Impacts are greatest near harvest when trees may be downgraded for cosmetic damage. Disulfoton, a systemic soil granular applied by either hand or motorcycle, is most used followed by foliarlyapplied chlorpyrifos and esfenvalerate. Disulfoton has the advantages of controlling both balsam twig aphid and spuce spider mite, and, being systemic, conserving predators. Disulfoton and esfenvalerate may be alternated if resistance management becomes an issue. Chlorpyrifos and esfenvalerate must be foliarly­ applied by commercial applicator by mist blower or high­ powered hose sprayer. The chlorpyrifos foliar spray is phytotoxic in some situations. Foliar applications are problematic because they are usually uneven, which significantly affects efficacy. Disulfoton is also the pesticide most used against spruce spider mite, followed by chlorpyrifos. Esfenvalerate has the advantage of also controlling balsam wooly adelgid to a limited extent but the disadvantage of causing spider mite populations to increase. The other four pests are minor but may be important in spotty situations. Hemlock rust mite and rosette bud mite are mainly controlled with foliarly­ applied dimethoate. There is no alternative to dimethoate for rosette bud mite. Balsam wooly adelgid is a major pest of spotty distribution that is mainly controlled with esfenvalerate spraying. If it is not controlled, the tree is killed or culled. White grubs are not very widespread and are controlled with soil­ applied chlorpyrifos at plant. Overall, for trees nearing harvest, twig aphids and spider mites are the critical pests 3 annually. Under those conditions, disulfoton is the OP that is critically needed because alternatives are somewhat ineffective. Without disulfoton, a significant amount of loss from downgrading and extra application costs would be sustained over the region annually. Disulfoton is important in resistance management and conserving beneficials. Sources: USDA Crop Profile for Christmas Trees in the North Carolina Mountains. 11/ 99. Personal Observation. NC Christmas Tree Crop tour with NC Cooperative Extension Service. 6/ 25­ 27/ 00. Pesticide labels. Metasystox­ R, Dimethoate 4EC, Di­ Syston 15%, Lorsban 4E. 6/ 00. Sidebottom, J. Personal communication. 6/ 22/ 00. Sidebottom, J. 1999. NC Crop Profile Christmas Trees, Mountain. 1997 North Carolina Christmas Tree Survey. NCASS. 3/ 98. Www. agr. state. nc. us/ stats/ trees/ xmastree. htm Prepared by: Michael K. Hennessey, Entomologist, EPA/ OPP/ BEAD/ HIB, 7/ 5/ 00. OP TOLERANCE REASSESSMENT USE/ USAGE MATRIX CROP SUMMARY 4 Site: Fraser Fir Christmas Trees Overall Confidence Rating: H Background: this analysis focuses on OP use. North Carolina is the only producer. Perennial crop with 6­ 10 year crop cycle. 34 million trees were grown on 24,000 acres with 1,600 growers in 1996. 66% of the farms are <10 acres. 93% of the trees were grown in five NC counties. Trees are cut and shipped fresh for homeowner ornamental use around Christmastime annually. 25% of the trees sold are retail. Value was $78 million in 1996 and $122 million in 1999. Commodity represented 27% of all US grown Christmas trees sold in 1999. Commercial Christmas trees of other varieties are produced in OR, MI, WA, OH, and WI. % Treated # Applications Rate (lb AI/ A) PHI (days) Organophosphate Pesticides Max Avg Max Avg Max Avg Min Avg Disulfoton 72 65 2 1 4.5 3 2 >14 Chlorpyrifos 7 62 11 0. 2511 Oxydemeton methyl 2 1 2 1 1 0. 5 3 3 Dimethoate 11 10 2 1 0.67 0.67 2 2 Confidence Rating: H= high confidence = data from several confirming sources; confirmed by personal experience M = medium confidence = data from only a few sources; may be some conflicting or unconfirmed info. L = low confidence = data from only one unconfirmed source Organophosphate Target Pests for Fraser Fir Major balsam twig aphid, spruce spider mite Minor hemlock rust mite, rosette bud mite, balsam wooly adelgid, white grubs Major = 20+% of all OP usage on pest; Moderate = 5­ 20% of all OP usage on pest; Minor =< 5% of all OP usage on pest Sources: USDA Crop Profile for Christmas Trees in the North Carolina Mountains. 11/ 99. Personal Observation. NC Christmas Tree Crop tour with NC Cooperative Extension Service. 6/ 25­ 27/ 00. Pesticide labels. Metasystox­ R, Dimethoate 4EC, Di­ Syston 15%, Lorsban 4E. 6/ 00. Sidebottom, J. Personal communication. 6/ 22/ 00. Sidebottom, J. 1999. NC Crop Profile Christmas Trees, Mountain. 1997 North Carolina Christmas Tree Survey. NCASS. 3/ 98. Www. agr. state. nc. us/ stats/ trees/ xmastree. htm Prepared By: Michael K. Hennessey Date: 7/ 5/ 00 Time: 17: 00 OP TOLERANCE REASSESSMENT USE/ USAGE MATRIX ­ PEST SUMMARY Page 5 5 Pest Organophosphate Efficacy Mkt Class Alt. Pesticide List Efficacy Mkt Constraints of Alternatives Crop: Fraser fir Christmas Trees Region: North Carolina Timing: All plant stages balsam twig aphid (Major) disulfoton ( hi P esfenvalerate med Esfenvalerate has an advantage of also controlling adelgid but disadvantage of flaring spider mite. Liquids (esfenvalarate and oxydemeton methyl, 2 apps required) are difficult to apply –coverage/ efficacy is poor with hose or mist blower most of the time depending on spacing or size of trees. Chlorpyrifos causes some phytotoxicity. Predators are important and are killed off by foliar sprays of esfenvalerate and chlorpyrifos. Tau fluvalinate (good efficacy), imidacloprid, azadirachtin (good efficacy) and bifenthrin are registered but not used. Triazimate and pymetrozine are in EPA pipeline. chlorpyrifos med O imidacloprid lo dimethoate lo O cinnamaldehyde lo oxydemeton methyl lo spruce spider mite (Major) disulfoton ( hi O abamectin lo Oil, tau­ fluvalinate (good efficacy adults only), pyridaben (good efficacy), and bifenthrin (not effective on eggs) are registered for this but not used. Hexythiazox doesn't control adults. Bifenazate (good efficacy) and clofentazine are in research pipeline. Chlorpyrifos causes some phytotoxicity. oxydemeton methyl lo O hexythiazox lo chlorpyrifos med hemlock rust mite (Minor) dimethoate ( hi O sulfur lo Pyridaben (good efficacy) is registered but not used. Sulfur was experimental use only. Clofentazine in research pipeline. rosette bud mite (Minor) dimethoate ( med Clofentazine in research pipeline. balsam wooly adelgid (Minor) oxydemeton methyl lo imidacloprid lo Esfenvalerate took over for lindane that was cancelled. It must be applied by high­ pressure hose. Older trees with infestations are culled. Predators are important and they are killed off by sprays. Pymetrozine is in research pipeline. Some phytotoxicity with chlorpyrifos, oil, and soap. chlorpyrifos lo esfenvalerate ( hi oil lo soap lo OP TOLERANCE REASSESSMENT USE/ USAGE MATRIX ­ PEST SUMMARY Page 6 Pest Organophosphate Efficacy Mkt Class Alt. Pesticide List Efficacy Mkt Constraints of Alternatives Crop: Fraser fir Christmas Trees Region: North Carolina Timing: All plant stages 6 white grubs (Minor) chlorpyrifos lo O methyl bromide ( med Soil application. Preplant soil methyl bromide is for root rot but would kill grubs also. Halofenozide soil use in EPA pipeline. ADDITIONAL INFORMATION: For above, ( ­excellent, ­good, ­poor. Market share: hi=> 20%, med= 5­ 20%, lo=< 5%. Class: P= pyrethroid, O= other SOURCES: USDA Crop Profile for Christmas trees in North Carolina mountains (Fraser fir) Sidebottom, J. 1/ 00. Registered alternatives for Fraser fir. Sidebottom, J. 6/ 00. Alternatives to Di­ syston 15G. Personal observation and talks with growers and extension personnel D. Hundley, J. Sidebottom, J. Moody, J. Owen. Extension tour of Fraser fir in NC. 6/ 25­ 27/ 00. Prepared By: M. Hennessey, Entomologist, OPP/ BEAD, 703­ 308­ 7076. Date: 7/ 5/ 00 Time: 17: 00

epa

2024-06-07T20:31:41.786304

regulations

EPA-HQ-OPP-2002-0061-0002

Rule

Fludioxonil; Re-establishment of Tolerance for Emergency Exemptions

[ Federal Register: May 29, 2002 ( Volume 67, Number 103)] [ Rules and Regulations] [ Page 37332­ 37335] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr29my02­ 8] ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP­ 2002­ 0061; FRL­ 7176­ 8] Fludioxonil; Re­ establishment of Tolerance for Emergency Exemptions AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ SUMMARY: This regulation re­ establishes a time­ limited tolerance for residues of the fungicide fludioxonil in or on caneberries at 5 parts per million ( ppm) for an additional 2 year period. This tolerance will expire and is revoked on December 31, 2003. This action is in response to EPA's granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) authorizing use of the pesticide on caneberries. Section 408( l)( 6) of the Federal Food, Drug, and Cosmetic Act ( FFDCA) requires EPA to establish a time­ limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. DATES: This regulation is effective May 29, 2002. Objections and requests for hearings, identified by docket control number OPP­ 2002­ 0061, must be received on or before July 29, 2002. ADDRESSES: Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit III. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket control number OPP­ 2002­ 0061 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 308­ 9364; e­ mail address: pemberton. libby@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Examples of Categories NAICS codes potentially affected entities ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select Laws and Regulations,'' Regulations and Proposed Rules,'' and then look up the entry for this document under the Federal Register''­­ Environmental Documents. You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. 2. In person. The Agency has established an official record for this action under docket control number OPP­ 2002­ 0061. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall i2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305­ 5805. II. Background and Statutory Findings EPA issued a final rule, published in the Federal Register of June 30, 1999 ( 64 FR 35037) ( FRL­ 6086­ 4), which announced that on its own initiative under section 408 of the FFDCA, 21 U. S. C. 346a, as amended by the FQPA of 1996 ( Public Law 104­ 170), it established a time­ limited tolerance for the residues of fludioxonil in or on caneberries at 5 ppm, with an expiration date of December 31, 2000. EPA established the tolerance because section 408( l)( 6) of the FFDCA requires EPA to establish a time­ limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA). Such tolerances can be [[ Page 37333]] established without providing notice or period for public comment. The tolerance was extended in the Federal Register of December 6, 2000 ( 65 FR 76169) ( FRL­ 6756­ 6) until December 31, 2001. EPA received a request to extend the use of fludioxonil on caneberries for this year's growing season due to the widespread development of pest resistance to previously­ used standard fungicides benomyl, iprodione, and vinclozolin; no curently available alternatives appear to provide suitable disease control and significant economic losses are expected with moderate to severe disease pressure. After having reviewed the submission, EPA concurs that emergency conditions exist. EPA has authorized under FIFRA section 18 the use of fludioxonil on caneberries for control of gray mold in Oregon and Washington. EPA assessed the potential risks presented by residues of fludioxonil in or on caneberries. In doing so, EPA considered the safety standard in FFDCA section 408( b)( 2), and decided that the necessary tolerance under FFDCA section 408( l)( 6) would be consistent with the safety standard and with FIFRA section 18. The data and other relevant material have been evaluated and discussed in the final rule published in the Federal Register of June 30, 1999 ( FR 64 35037) ( FRL­ 6086­ 4). Based on that data and information considered, the Agency reaffirms that extension of the time­ limited tolerance will continue to meet the requirements of section 408( l)( 6). Therefore, the time­ limited tolerance is extended for an additional 2 year period. EPA will publish a document in the Federal Register to remove the revoked tolerance from the Code of Federal Regulations ( CFR). Although this tolerance will expire and is revoked on December 31, 2002, under FFDCA section 408( l)( 5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on caneberries after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA and the application occurred prior to the revocation of the tolerance. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. III. Objections and Hearing Requests Under section 408( g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) provides essentially the same process for persons to object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days. A. What Do I Need To Do To File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP­ 2002­ 0061 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before July 29, 2002. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 202) 260­ 4865. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305­ 5697, by e­ mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit III. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 2. Mail your copies, identified by docket control number OPP­ 2002­ 0061, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 2. You may also send an electronic copy of your request via e­ mail to: opp­ docket@ epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries. [[ Page 37334]] B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested ( 40 CFR 178.32). IV. Regulatory Assessment Requirements This final rule re­ establishes a time­ limited tolerance under FFDCA section 408. The Office of Management and Budget ( OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104­ 4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low­ Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104­ 113, section 12( d) ( 15 U. S. C. 272 note). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 petition under FFDCA section 408, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' Policies that have federalism implications'' is defined in the Executive order to include regulations that have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408( n)( 4). For these same reasons, the Agency has determined that this rule does not have any tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' Policies that have tribal implications'' is defined in the Executive order to include regulations that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. V. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a major rule'' as defined by 5 U. S. C. 804( 2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 16, 2002. Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180­­ [ AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U. S. C. 321( q), 346( a) and 374. [ sect] 180.516 [ Amended] 2. In [ sect] 180.516, revise the entry in paragraph ( b) for Caneberries to read as follows: * * * * * ( b) * * * ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Parts per Expiration/ Commoditiy million revocation date ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ * * * * * * * Caneberry............................... 5.0 12/ 31/ 03 * * * * * * * ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ [[ Page 37335]] * * * * * [ FR Doc. 02­ 13252 Filed 5­ 28­ 02; 8: 45 am] BILLING CODE 6560­ 50­ S

epa

2024-06-07T20:31:41.791277

regulations

EPA-HQ-OPP-2002-0065-0001

Notice

Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food

[ Federal Register: June 5, 2002 ( Volume 67, Number 108)] [ Notices] [ Page 38660­ 38664] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr05jn02­ 42] ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ENVIRONMENTAL PROTECTION AGENCY [ OPP­ 2002­ 0065; FRL­ 7177­ 4] Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket control number OPP­ 2002­ 0065, must be received on or before July 5, 2002. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. C. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP­ 2002­ 0065 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: Sidney Jackson, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 305­ 7610; e­ mail address: jackson. Sidney@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Examples of Categories NAICS codes potentially affected entities ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select Laws and Regulations,'' Regulations and Proposed Rules,'' and then look up the entry for this document under the Federal Register­­ Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. 2. In person. The Agency has established an official record for this action under docket control number OPP­ 2002­ 0065. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Highway, Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305­ 5805. C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP­ 2002­ 0065 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305­ 5805. 3. Electronically. You may submit your comments electronically by e­ mail to: opp­ docket@ epa. gov, or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in Wordperfect 6.1/ 8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP­ 2002­ 0065. Electronic comments may also be filed online at many Federal Depository Libraries. D. How Should I Handle CBI That I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the [[ Page 38661]] information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. What Action is the Agency Taking? EPA has received a pesticide petition as follows proposing the establishment and/ or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in section 408( d)( 2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition. List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 17, 2002. Robert Forrest, Acting Director, Registration Division, Office of Pesticide Programs. III. Summary of Petition The petitioner summary of the pesticide petition is printed below as required by section 408( d)( 3) of the FFDCA. The summary of the petition was prepared by Valent U. S. A. Corporation, P. O. Box 8025, Walnut Creek, CA 94596­ 8025 and represents the view of Valent U. S. A. Corporation. EPA is publishing the petition summary verbatim without editing it in any way. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed. PP 1E6272, 1E6285, and 2E6353 EPA has received pesticide petitions ( PP) 1E6272, 1E6285, and 2E6353 from the Interregional Research Project Number 4 ( IR­ 4), Technology Centre of New Jersey, Rutgers, the State University of New Jersey, 681 U. S. Highway No. 1 South, North Brunswick, NJ 08902­ 3390 proposing, pursuant to section 408( d) of the FFDCA, 21 U. S. C. 346a( d), to amend 40 CFR part 180 by establishing tolerances for residues of pyriproxyfen, 2­[ 1­ methyl­ 2­( 4­ phenoxyphenoxy) ethoxy] pyridine, in or on the raw agricultural commodities as follows: 1. PP 1E6272 proposes tolerances for lychee, longan, Spanish lime, rambutan, and pulasan at 0.3 parts per million ( ppm). 2. PP 1E6285 proposes tolerances for guava, feijoa, jaboticaba, wax jambu, starfruit, passionfruit, and acerola at 0.1 ppm, and 3. PP 2E6353 proposes tolerances for Bushberry subgroup 13 B at 1.0 ppm and lingonberry, juneberry, and salal at 1.0 ppm. EPA has determined that the petitions contain data or information regarding the elements set forth in section 408( d)( 2) of the Federal Food Drug and Cosmetic Act ( FFDCA); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petitions. Additional data may be needed before EPA rules on the petitions. Pyriproxyfen is manufactured by Sumitomo Chemical Company, represented in the United States by Valent U. S. A. Corporation. A. Residue Chemistry 1. Plant metabolism. Metabolism of 14C­ pyriproxyfen labelled in the phenoxyphenyl ring and in the pyridyl ring has been studied in cotton, apples, tomatoes, lactating goats, laying hens and rats. The major metabolic pathways in plants is aryl hydroxylation and cleavage of the ether linkage, followed by further metabolism into more polar products by further oxidation and/ or conjugation reactions. However, the bulk of the radiochemical residue on raw agricultural commodities ( RAC) samples remained as parent. Comparing metabolites detected and quantified from cotton, apple, tomato, goat, hen and rat shows that there are no significant aglycones in plants which are not also present in the excreta or tissues of animals. The residue of concern is best defined as the parent, pyriproxyfen. Ruminant and poultry metabolism studies demonstrated that transfer of administered 14C­ residues to tissues was low. Total 14C­ residues in goat milk, muscle and tissues accounted for less than 2% of the administered dose, and were less than 1 ppm in all cases. In poultry, total 14C residues in eggs, muscle and tissues accounted for about 2.7% of the administered dose, and were less than 1 ppm in all cases except for gizzard. 2. Analytical method. Practical analytical methods for detecting and measuring levels of pyriproxyfen ( and relevant metabolites) have been developed and validated in/ on all appropriate agricultural commodities, respective processing fractions, milk, animal tissues, and environmental samples. The extraction methodology has been validated using aged radiochemical residue samples from metabolism studies. The methods have been validated in cottonseed, apples, soil, and oranges at independent laboratories. EPA has successfully validated the analytical methods for analysis of cottonseed, pome fruit, nutmeats, almond hulls, and fruiting vegetables. The limit of detection of pyriproxyfen in the methods is 0.01 ppm which will allow monitoring of food with residues at the levels proposed for the tolerances. 3. Magnitude of residues ­­ i. Lychee. Three lychee field residue trials were conducted in 1998 in EPA Region 13. Each field site received two pyriproxyfen applications at 0.11 lb active ingredient/ acre ( a. i./ A), with an interval of 10 to 11 days between applications, and a preharvest interval of 11 to 13 days. Pyriproxyfen residues on treated lychee samples ranged from [[ Page 38662]] 0.0759 to 0.272 ppm. These data support a tolerance for pyriproxyfen in or on lychee of 0.3 ppm. ii. Guava. Three guava field residue trials were conducted in 1999 in EPA Region 13. Each field site received two pyriproxyfen applications at 0.11 lb a. i./ A, with an interval of 13 days between applications, and a pre­ harvest interval of 14 to 15 days. Pyriproxyfen residues on treated guava samples ranged from < 0.025 to 0.055 ppm. The data support a tolerance for pyriproxyfen in or on guava of 0.1 ppm. iii. Blueberry. Eight blueberry field residue trials were conducted in 1999. Three trials were conducted in EPA Region 2, three trials in EPA Region 5, one trial in EPA Region 1, and one trial in EPA Region 12. Each field site received two pyriproxyfen applications at 0.1 lb ai/ A with a retreatment interval ranging between 13 to 15 days. At seven trial locations samples were collected 6 to 8 days after the last application. At one trial location, samples were collected at 2, 7, 10, 14 and 21 days after the last application. Pyriproxyfen residues ranged from 0.14 ppm to 0.64 ppm for treated samples collected 6 to 8 days after the last application. In the residue decline study, pyriproxyfen residues ranged from 0.10 ppm to 0.22 ppm in treated samples collected at the first three sampling intervals, declining to as low as 0.03 ppm after 21 days after the last application. These data support a tolerance for pyriproxyfen in or on blueberries and commodities within the bushberry subgroup of 1.0 ppm. B. Toxicological Profile An assessment of toxic effects caused by pyriproxyfen is discussed in Unit III. A. and Unit III. B. of the Federal Register dated April 4, 2001, ( FRL­ 6772­ 4) ( 66 FR 17883). 1. Animal metabolism. The absorption, tissue distribution, metabolism and excretion of 14C­ labeled pyriproxyfen were studied in rats after single oral doses of 2 or 1,000 milligrams/ kilograms body weight ( mg/ kg bw) ( phenoxyphenyl and pyridyl label), and after a single oral dose of 2 mg/ kg bw, phenoxyphenyl label only, following 14 daily oral doses at 2 mg/ kg bw of unlabelled material. For all dose groups, most ( 88­ 96%) of the administered radiolabel was excreted in the urine and feces within two days after radiolabeled test material dosing, and 92­ 98% of the administered dose was excreted within seven days. Seven days after dosing, tissue residues were generally low, accounting for no more than 0.3% of the dosed 14C. Radiocarbon concentrations in fat were the higher than in other tissues analyzed. Recovery in tissues over time indicates that the potential for bioaccumulation is minimal. There were no significant sex or dose­ related differences in excretion or metabolism. 2. Metabolite toxicology. Metabolism studies of pyriproxyfen in rats, goats and hens, as well as the fish bioaccumulation study demonstrate that the parent is very rapidly metabolized and eliminated. In the rat, most ( 88­ 96%) of the administered radiolabel was excreted in the urine and feces within 2 days of dosing, and 92­ 98% of the administered dose was excreted within 7 days. Tissue residues were low 7 days after dosing, accounting for no more than 0.3% of the dosed 14C. Because parent and metabolites are not retained in the body, the potential for acute toxicity from in situ formed metabolites is low. The potential for chronic toxicity is adequately tested by chronic exposure to the parent at the maximum tolerated dose ( MTD) and consequent chronic exposure to the internally formed metabolites. Seven metabolites of pyriproxyfen, 4'­ OH­ pyriproxyfen, 5''­ OH­ pyriproxyfen, desphenyl­ pyriproxyfen, POPA, PYPAC, 2­ OH­ pyridine and 2,5­ diOH­ pyridine, have been tested for mutagenicity, via Ames Assay, and acute oral toxicity to mice. All seven metabolites were tested in the Ames assay with and without S9 at doses up to 5,000 micro­ grams per plate or up to the growth inhibitory dose. The metabolites did not induce any significant increases in revertible colonies in any of the test strains. Positive control chemicals showed marked increases in reverting colonies. The acute toxicity to mice of 4'­ OH­ pyriproxyfen, 5''­ OH­ pyriproxyfen, desphenyl­ pyriproxyfen, POPA, and PYPAC did not appear to markedly differ from pyriproxyfen, with all metabolites having acute oral Lethal Dose ( LD50) values greater than 2,000 mg/ kg bw. The two pyridines, 2­ OH­ pyridine and 2,5­ diOH­ pyridine, gave acute oral LD50 values of 124 ( male) and 166 ( female) mg/ kg bw, and 1,105 ( male) and 1,000 ( female) mg/ kg bw, respectively. 3. Endocrine disruption. Pyriproxyfen is specifically designed to be an insect growth regulator and is known to produce juvenoid effects on arthropod development. However, this mechanism­ of­ action in target insects and some other arthropods has no relevance to any mammalian endocrine system. While specific tests, uniquely designed to evaluate the potential effects of pyriproxyfen on mammalian endocrine systems have not been conducted, the toxicology of pyriproxyfen has been extensively evaluated in acute, sub­ chronic, chronic, developmental, and reproductive toxicology studies including detailed histopathology of numerous tissues. The results of these studies show no evidence of any endocrine­ mediated effects and no pathology of the endocrine organs. Consequently, Valent concludes that pyriproxyfen does not possess estrogenic or endocrine disrupting properties applicable to mammals. C. Aggregate Exposure 1. Dietary exposure. An evaluation of chronic dietary exposure including both food and drinking water has been performed for the U. S. population and various sub­ populations including infants and children. No acute dietary endpoint and dose was identified in the toxicology data base for pyriproxyfen, therefore, the Valent Corporation concludes that there is a reasonable certainty of no harm from acute dietary exposure. i. Food. Chronic dietary exposure to pyriproxyfen residues was calculated for the U. S. population and 25 population subgroups assuming tolerance level residues, processing factors from residue studies, and 100% of the crop­ treated. The analyses included residue data for all existing uses, pending uses, and proposed new uses. The results from several representative subgroups are listed below. Chronic exposure to the overall U. S. population is estimated to be 0.002984 mg/ kg bw/ day, representing 0.9% of the Reference Dose ( RfD). For the most highly exposed sub­ population, children 1 to 6 years of age, exposure is calculated to be 0.007438 mg/ kg bw/ day, or 2.1% of the RfD. Generally speaking, the Agency has no cause for concern if total residue contribution for established and proposed tolerances is less than 100% of the RfD. Calculated Chronic Dietary Exposures to the Total U. S. Population and Selected Sub­ Populations to Pyriproxyfen Residues in Food ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Exposure ( mg/ kg bw/ Population Subgroup day) Percent of RfD ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Total U. S. population ( all 0.002984 0.853 seasons) Children ( 1­ 6 years) 0.007438 2.125 Non­ Nursing infants (< 1 year 0.006483 1.852 old) All infants (< 1 year old) 0.005604 1.601 Children ( 7­ 12 years) 0.004159 1.188 [[ Page 38663]] Females ( 13+/ nursing) 0.002964 0.847 Nursing infants (< 1 year old) 0.002601 0.743 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ii. Drinking water. Since pyriproxyfen is applied outdoors to growing agricultural crops, the potential exists for pyriproxyfen or its metabolites to reach ground or surface water that may be used for drinking water. Because of the physical properties of pyriproxyfen, it is unlikely that pyriproxyfen or its metabolites can leach to potable ground water. To quantify potential exposure from drinking water, surface water concentrations for pyriproxyfen were estimated using GENEEC 1.3. The average 56­ day concentration predicted in the simulated pond water was 0.16 parts per billion ( ppb). Using standard assumptions about body weight and water consumption, the chronic exposure to pyriproxyfen from this drinking water would be 4.57 x 10­ 6 and 1.6 x 10­ 5 mg/ kg bw/ day for adults and children, respectively; 0.0046% of the RfD ( 0.35 mg/ kg/ day) for children. Based on this worse case analysis, the contribution of water to the dietary risk is negligible. 2. Non­ dietary exposure. Pyriproxyfen is currently registered for use on residential non­ food sites. Pyriproxyfen is the active ingredient in numerous registered products for flea and tick control. Formulations include foggers, aerosol sprays, emulsifiable concentrates, and impregnated materials ( pet collars). With the exception of the pet collar uses, consumer use of pyriproxyfen typically results in acute and short­ term intermittent exposures. No acute dermal, or inhalation dose or endpoint was identified in the toxicity data for pyriproxyfen. Similarly, doses and endpoints were not identified for short and intermediate term dermal or inhalation exposure to pyriproxyfen. The Valent Corporation has concluded that there are reasonable certainties of no harm from acute, short­ term, and intermediate­ term dermal and inhalation occupational and residential exposures due to the lack of significant toxicological effects observed. Chronic residential post­ application exposure and risk assessments were conducted to estimate the potential risks from pet collar uses. The risk assessment was conducted using the following assumptions: application rate of 0.58 mg active ingredient ( ai)/ day, average bw for a 1­ 6 year old child of 10 kg, the a. i. dissipates uniformly through 365 days ( the label instruct to change collar once a year), 1% of the active ingredient is available for dermal and inhalation exposure per day ( assumption from Draft EPA Standard Operating Procedures ( SOPs) for Residential Exposure Assessments, December 18, 1997). The assessment also assumes an absorption rate of 100%. This is a conservative assumption since the dermal absorption was estimated to be 10%. The estimated chronic term MOE was 61,000 for children, and 430,000 for adults. The risk estimates indicate that potential risks from pet collar uses do not exceed the Agency's level of concern. D. Cumulative Effects Section 408( b)( 2)( D)( v) requires that the Agency must consider available information'' concerning the cumulative effects of a particular pesticide's residues and other substances that have a common mechanism of toxicity.'' Available information in this context include not only toxicity, chemistry, and exposure data, but also scientific policies and methodologies for understanding common mechanisms of toxicity and conducting cumulative risk assessments. For most pesticides, although the Agency has some information in its files that may turn out to be helpful in eventually determining whether a pesticide shares a common mechanism of toxicity with any other substances, EPA does not at this time have the methodologies to resolve the complex scientific issues concerning common mechanism of toxicity in a meaningful way. There are no other pesticidal compounds that are structurally related to pyriproxyfen and have similar effects on animals. In consideration of potential cumulative effects of pyriproxyfen and other substances that may have a common mechanism of toxicity, there are currently no available data or other reliable information indicating that any toxic effects produced by pyriproxyfen would be cumulative with those of other chemical compounds. Thus, only the potential risks of pyriproxyfen have been considered in this assessment of aggregate exposure and effects. Valent will submit information for EPA to consider concerning potential cumulative effects of pyriproxyfen consistent with the schedule established by EPA at 62 FR 42020 ( Aug. 4, 1997) and other subsequent EPA publications pursuant to the Food Quality Protection Act. E. Safety Determination 1. U. S. population. ­­ i. Chronic dietary exposure and risk adult sub­ populations. The results of the chronic dietary exposure assessment described above demonstrate that estimates of chronic dietary exposure for all existing, pending and proposed uses of pyriproxyfen are well below the chronic RfD of 0.35 mg/ kg bw/ day. The estimated chronic dietary exposure from food for the overall U. S. population and many non­ child/ infant subgroups is from 0.002123 to 0.003884 mg/ kg bw/ day, 0.607 to 1.100% of the RfD. Addition of the small but worse case potential chronic exposure from drinking water ( calculated above) increases exposure by only 4.57 x 10­ 6 mg/ kg bw/ day and does not change the maximum occupancy of the RfD significantly. Generally, the Agency has no cause for concern if total residue contribution is less than 100% of the RfD. Valent concludes that there is a reasonable certainty that no harm will result to the overall U. S. Population or any non­ child/ infant subgroups from aggregate, chronic dietary exposure to pyriproxyfen residues. ii. Acute dietary exposure and risk adult sub­ populations. No acute dietary endpoint and dose were identified in the toxicology data base for pyriproxyfen; therefore, it can be concluded that there is a reasonable certainty that no harm will result to the overall U. S. population or any non­ child/ infant subgroups from aggregate, acute dietary exposure to pyriproxyfen residues. iii. Non­ dietary exposure and aggregate risk adult sub­ populations. Acute, short term, and intermediate term dermal and inhalation risk assessments for residential exposure are not required due to the lack of significant toxicological effects observed. The results of a chronic residential post­ application exposure and risk assessment for pet collar uses demonstrate that potential risks from pet collar uses do not exceed the Agency's level of concern. The estimated chronic term MOE for adults was 430,000. 2. Infants and children ­­ i. Safety factor for infants and children. In assessing the potential for additional sensitivity of infants and children to residues of pyriproxyfen, FFDCA section 408 provides that EPA shall apply an additional margin of safety, up to 10­ fold, for added protection for infants and children in the case of threshold effects unless EPA determines [[ Page 38664]] that a different margin of safety will be safe for infants and children. The toxicological data base for evaluating pre­ natal and post­ natal toxicity for pyriproxyfen is complete with respect to current data requirements. There are no special prenatal or postnatal toxicity concerns for infants and children, based on the results of the rat and rabbit developmental toxicity studies or the 2­ generation reproductive toxicity study in rats. Valent concludes that reliable data support use of the standard 100­ fold uncertainty factor and that an additional uncertainty factor is not needed for pyriproxyfen to be further protective of infants and children. ii. Chronic dietary exposure and risk infants and children. Using the conservative exposure assumptions described above, the percentage of the RfD that will be utilized by chronic dietary ( food only) exposure to residues of pyriproxyfen ranges from 0.002601 mg/ kg bw/ day for nursing infants, up to 0.007438 mg/ kg bw/ day for children ( 1 to 6 years of age), 0.743 to 2.125% of the RfD, respectively. Adding the worse case potential incremental exposure to infants and children from pyriproxyfen in drinking water ( 1.6 x 10­ 5 mg/ kg bw/ day) does not materially increase the aggregate, chronic dietary exposure and only increases the occupancy of the RfD by 0.0046% to 2.130% for Children ( 1 to 6 years of age). EPA generally has no concern for exposures below 100% of the RfD because the RfD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. Valent concludes that there is a reasonable certainty that no harm will result to infants and children from aggregate, chronic dietary exposure to pyriproxyfen residues. iii. Acute dietary exposure and risk infants and children. No acute dietary endpoint and dose were identified in the toxicology data base for pyriproxyfen; therefore, Valent believes that there is a reasonable certainty that no harm will result to infants and children from aggregate, acute dietary exposure to pyriproxyfen residues. iv. Non­ dietary exposure and aggregate risk infants and children. Acute, short term, and intermediate term dermal and inhalation risk assessments for residential exposure are not required due to the lack of significant toxicological effects observed. The results of a chronic residential post­ application exposure and risk assessment for pet collar uses demonstrate that potential risks from pet collar uses do not exceed the Agency's level of concern. The estimated chronic term MOE for children was 61,000. F. International Tolerances There are no presently existing Codex maximum residue levels ( MRLs) for pyriproxyfen. [ FR Doc. 02­ 13810 Filed 6­ 4­ 02; 8: 45 am] BILLING CODE 6560­ 50­ S

epa

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regulations

EPA-HQ-OPP-2002-0068-0002

Supporting & Related Material

1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON DC 20460 Office of Prevention, Pesticides and Toxic Substances May 25, 2001 MEMORANDUM SUBJECT: RFA/ SBREFA Certification for Import Tolerance Revocation FROM: Denise Keehner, Division Director, Biological and Economic Analysis Division (7503C), Office of Pesticide Programs, OPPTS, U. S. Environmental Protection Agency TO: Public Docket concerning Tolerance Revocation Rulemaking, Proposed or Final Issue: Because tolerance revocation is rule­ making, the Agency needs to certify ­­ under RFA/ SBREFA ­­ that the tolerance revocation does not impose a significant adverse impact on a substantial number of small entities or conduct an initial and final regulatory flexibility analysis and convene a review panel. Currently, OPP is trying to update the FR notice from 1997 that made a broad, general certification. The same conditions apply now as they did in 1997, but the supporting documentation is being updated, so it is necessary to reconstruct the basis for Agency expectations that import tolerance revocations will not generate significant impacts on substantial numbers of small entities. The primary RFA/ SBREFA focus is on U. S. based import businesses who trade in products that may contain one or more residues being banned under the tolerance revocation. Preliminary Analysis: The arguments for why we would not expect to see significant impacts on a substantial number of small entities can be put into three different categories: 1. Cases where substantial numbers of small entities are not affected because: a. Import companies are not small businesses. b. If import companies are small businesses, then too few are affected to be ineligible for SBREFA certification. 2. Cases where impact on import commodity price is not significant (minimal supply effects) because: a. Affected commodity is widely traded on international markets/ exchanges, and only a small proportion of overall production is treated. b. A small proportion of a crop is treated within a country, suggested the supply within that country will be relatively unaffected. c. There are sufficient alternatives for the chemical with the cancelled tolerance, and these alternatives have few, if any, impacts on output or production costs for the raw agricultural commodity. 3. Cases where there are limited alternatives for the pesticide in a given country, leading 2 to an increase in the supply price, but: a. The supply price is only a proportion of the import price, where the majority of the price reflects transportation and other distribution costs. b. The supply price increases for a particular commodity from a particular country, but it does not impose a significant impact on importer sales because the import company has diversified sales. c. The supply price increases for a particular commodity from a particular country, but there are other sources of the commodity, and the transaction costs of utilizing other suppliers is sufficiently low that it doesn't significantly affect the overall sales of the importing company. Therefore, if ANY of these eight conditions hold, then we can certify that there is no SBREFA issue. Conversely, in order for there to be consideration of a SBREFA concern that would require more detailed analysis, ALL of the following have to hold: 1. There are importers for a particular commodity affected by the tolerance revocation, who qualify as small business under SBA guidelines; AND 2. there is a substantial number of small importers whose sales are affected by the tolerance revocation; AND 3. the affected commodity is NOT widely traded on international markets; AND 4. a sizable proportion of the production in the limited geographic production region is treated with the particular pesticide (suggesting potential supply effects); AND 5. there a limited and/ or expensive alternatives for the particular pesticide in the limited geographic production region, with a concomitant potential for sizable yield loss or increase in cost of production; AND 6. the price of the raw agricultural commodity is a large component of the sales price of the import; AND 7. the importing companies are not diversified, and the increase in raw commodity cost will lead to a significant decline in sales revenue. There is a negligible joint probability of all these conditions holding simultaneously, so I believe it appropriate for the Agency to take the position that import tolerance revocations can be certified under RFA/ SBREFA. I base this conclusion on several observations: most commodities subject to import tolerance revocation are widely traded on international markets (according to USDA's data on agricultural imports and exports) and BEAD's data on foreign pesticide use suggest it is rare for a single pesticide to be extensively used in each production/ export region, such that there is a minimal chance of import tolerance revocation leading to price/ cost increases for importers with an attendant SBREFA concern. Even in the very unlikely event that an import tolerance revocation leads to significant price/ cost increases for a particular commodity, many importers of agricultural commodities are diversified companies dealing in many commodities, so that a price/ cost increase for one commodity will not significantly affect total company revenues. At the same time, it will be useful to continue building a set of data describing why one or more of these seven conditions is not likely to hold. The plan for the medium to long term is to collect such supporting data, sometimes using general industry profiles and sometimes using analyses of specific commodity/ chemical combinations.

epa

2024-06-07T20:31:41.803955

regulations

EPA-HQ-OPP-2002-0069-0001

Notice

Methodology for Lower Toxicity Pesticide Chemicals; Notice of Availability.

40732 Federal Register / Vol. 67, No. 114 / Thursday, June 13, 2002 / Notices TABLE 1.— REGISTRATIONS WITH REQUESTS FOR AMENDMENTS TO DELETE USES IN CERTAIN PESTICIDE REGISTRATIONS— Continued Registration no. Product Chemical Name Delete From Label 067760– 00044 Dimethoate 4 E Dimethoate Residential and housefly uses 068156– 00004 Dintec HFP Trifluralin Trifluralin Rapeseed EPA company numbers 000264, 002217, 040083, 042750 and 067760 have requested a 30– day comment period for registrations listed. Users of these products who desire continued use on crops or sites being deleted should contact the applicable registrant listed in Table 2 below before December 10, 2002, to discuss withdrawal of the application for amendment. This 180– day period will also permit interested members of the public to intercede with registrants prior to the Agency's approval of the deletion. Table 2 includes the names and addresses of record for all registrants of the products in Table 1, in sequence by EPA company number. TABLE 2.— REGISTRANTS REQUESTING VOLUNTARY CANCELLATION EPA Company no. Company Name and Address 000264 Aventis Cropscience USA LP, 2 T. W. Alexander Drive Box 12014, Research Triangle Park, NC 27709. 001386 Universal Cooperatives Inc., 1300 Corporate Center Curve, Eagan, MN 55121. 002217 PBI/ Gordon Corp., Attn: Craig Martens, Box 014090, Kansas City, MO 64101. 008660 Earth Care, Division of United Industries Corporatio, Box 142642, St. Louis, MO 63114. 010163 Gowan Co., Box 5569, Yuma, AZ 85366. 040083 Inquinosa Internacional, S. A., Paseo De La Castellance, 123, 9 B, 28046 Mardr, . 042750 Pyxis Regulatory Consulting, Agent For: Albaugh Inc., 11324 17th Ave. Ct. NW, Gig Harbor, WA 98332. 062719 Dow AgroSciences LLC, 9330 Zionsville Rd 308/ 2E225, Indianapolis, IN 46268. 067760 Cheminova Inc., Oak Hill Park 1700 Route 23 ­ Ste 210, Wayne, NJ 07470. 068156 Dintec Agrichemicals, 9330 Zionsville Rd, Indianapolis, IN 46268. III. What is the Agency Authority for Taking This Action? Section 6( f)( 1) of FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be amended to delete one or more uses. The Act further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register. Thereafter, the Administrator may approve such a request. IV. Procedures for Withdrawal of Request Registrants who choose to withdraw a request for use deletion must submit such withdrawal in writing to James A. Hollins, at the address under FOR FURTHER INFORMATION CONTACT, postmarked on or before December 10, 2002. V. Provisions for Disposition of Existing Stocks The Agency has authorized the registrants to sell or distribute product under the previously approved labeling for a period of 18 months after approval of the revision, unless other restrictions have been imposed, as in special review actions. List of Subjects Environmental protection, Pesticides and pests. Dated: May 29, 2002. Linda Vlier Moos, Acting Director, Information Resources and Services Division. [FR Doc. 02– 14997 Filed 6– 12– 02; 8: 45 a. m.] BILLING CODE 6560– 50– S ENVIRONMENTAL PROTECTION AGENCY [OPP– 2002– 0069; FRL– 7177– 9] Methodology for Lower Toxicity Pesticide Chemicals; Notice of Availability AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA is soliciting comments on a document entitled `` Methodology for Determining the Data Needed and the Types of Assessments Necessary to Make FFDCA Section 408 Safety Determinations for Lower Toxicity Pesticide Chemicals. '' Interested parties may request a copy of the Agency's proposed guidance document as set forth in Unit IB of this Notice. DATES: Comments, identified by docket ID number OPP– 2002– 0069, must be received on or before September 11, 2002. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP– 2002– 0069 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 VerDate jun< 06> 2002 18: 18 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 13JNN1. SGM pfrm15 PsN: 13JNN1 40733 Federal Register / Vol. 67, No. 114 / Thursday, June 13, 2002 / Notices Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 703– 305– 6304; fax number: 703– 305– 0599; e­ mail address: boyle. kathryn@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. This action may, however, be of interest to those persons who are or may be required to conduct testing of chemical substances ­ under the Federal Food, Drug, and Cosmetic Act (FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations, '' `` Regulations and Proposed Rules, '' and then look up the entry for this document under the `` Federal Register''— Environmental Documents. You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. 2. In person. The Agency has established an official record for this action under docket ID number OPP– 2002– 0069. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305– 5805. C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP– 2002– 0069 in the subject line on the first page of your response. 1. By mail. Submit your comments to: PIRIB, Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: PIRIB Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305– 5805. 3. Electronically. You may submit your comments electronically by e­ mail to: opp­ docket@ epa. gov, or you can submit a computer disk as described in this unit. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in WordPerfect 6.1/ 8.0 or ASCII file format. All comments in electronic form must be identified by docket ID number OPP– 2002– 0069. Electronic comments may also be filed online at many Federal Depository Libraries. D. How Should I Handle CBI that I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the notice or collection activity. 7. Make sure to submit your comments by the deadline in this notice. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. What Action is the Agency Taking? The Agency is announcing the availability of a methodology for assessing the hazards and risks of lower toxicity pesticide chemicals for public comment and review. This paper describes how lower toxicity pesticide chemicals, including inert ingredients, would be evaluated for use in pesticide products. The OPP is the Office within the Environmental Protection Agency (EPA or the Agency) that evaluates pesticide products. OPP's responsibilities (all of which could be affected by the use of this new methodology) include: registration of new active ingredients, reregistration of older active ingredients, reassessment of both tolerances and tolerances exemptions, approval of new inert ingredients, and list reclassification of inert ingredients. Development of this methodology began as a result of OPP's need to (1) develop a new methodology for assessing inert ingredients to comply with the requirements of the Food Quality Protection Act (FQPA) of 1996 which amended both the FFDCA and the FIFRA, and (2) to improve the efficiency and effectiveness of the inert review process. In many instances, a chemical can be used as an inert ingredient in some pesticide products and as an active ingredient in other VerDate May< 23> 2002 14: 07 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 13JNN1. SGM pfrm17 PsN: 13JNN1 40734 Federal Register / Vol. 67, No. 114 / Thursday, June 13, 2002 / Notices pesticide products. Since FFDCA section 408 makes no distinction between active and inert ingredients of a pesticide product, EPA may use this tiered data screening methodology when evaluating any pesticide chemical of apparent low or low/ moderate toxicity, regardless of whether it might be characterized as an active or inert ingredient. At this time, EPA has completed review of two tolerance exemption petitions and over 200 tolerance reassessments for low or low/ moderate toxicity chemicals using essentially the process described in this paper. More reviews are underway. Based on these experiences, OPP intends to continue its chemical­ by­ chemical reviews of pesticide chemicals according to the process described herein for the foreseeable future. However, EPA remains interested in further improvements in the efficiency and reliability of its process, and therefore welcomes comments from interested persons. After evaluating several alternatives, OPP believes that a screening methodology is the most appropriate way to handle the variety of hazard and exposure issues posed by inert ingredients. This screening methodology will allow OPP to make decisions in a streamlined manner for low or low/ moderate toxicity chemical substances. By being able to quickly review and approve the use of these chemical substances, more low or low/ moderate toxicity chemical substances will be available for use in pesticide products. OPP will also be able to focus its resources on those chemical substances of potentially higher toxicity requiring in­ depth evaluation. OPP has incorporated elements of a tiered data approach into this methodology. For these lower toxicity chemicals, OPP would use existing information on the hazard potential (both human health and ecological) of a chemical substance as the basis for deciding if additional data are needed to support the use of the chemical. The hazard potential ­ the toxicity ­ is the driving force in determining tier placement. Chemical substances that are of low or low/ moderate toxicity may be appropriately placed in a lower tier, with fewer data needed to make the safety finding. Chemicals of higher toxicity that can not be appropriately addressed in the lower tiers would be evaluated in a manner substantially similar to that of an active ingredient. The process described in this paper has three tiers, with the first tier being subdivided into Tiers 1a and 1b. The process begins with a preliminary Tier determination that is based on widely available information on chemical families and categories which includes the hazards associated with these chemicals. Later as the Agency begins to review chemical­ specific or surrogate information in the open literature, the preliminary Tier determination may be revised. The methodology is intended to provide guidance to EPA personnel and decision­ makers, and to pesticide registrants. The policies and process described in this methodology are not binding on either EPA or pesticide registrants, and EPA may modify or disregard the process described herein where circumstances warrant and without prior notice. Likewise, pesticide registrants may assert that this process is not appropriate generally or not applicable to a specific pesticide chemical or situation. III. Questions/ Issues for Public Comment A significant challenge faced in developing a methodology for a comprehensive assessment program for chemicals of low or low/ moderate toxicity is determining the most appropriate procedure for evaluating such a diverse group of substances, with a very wide range of physical/ chemical characteristics. Does the screening approach as described in the methodology paper reflect a workable, logical approach? It is likely that a large percentage of inert ingredients are not likely to be of significant toxicological concern. The Agency's expectation is that on the order of 50% of inert ingredients would be of low or low/ moderate risk. At the same time, EPA must be able to identify problematic inert ingredients and then have the resources to take appropriate action to analyze and reduce these risks. Would this methodology give the Agency the necessary flexibility while allowing for an effficient and productive process? Several sources for credible, scientifically valid chemical information are given in the policy paper. What other possible sources of readily available credible, scientifically valid chemical information are available? The Agency has described, as best possible at this beginning stage, the process that would be used to evaluate inert ingredients as well as the role played by a petitioner for a tolerance or tolerance exemption or those seeking to support a chemical during tolerance reassessment. What additional information would be helpful to the regulated community? List of Subjects Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests. Dated: June 7, 2002. Marcia E. Mulkey, Director, Office of Pesticide Programs. [FR Doc. 02– 14996 Filed 6– 12– 02; 8: 45 am] BILLING CODE 6560– 50– S ENVIRONMENTAL PROTECTION AGENCY [FRL– 7230– 6] Persistent Organic Pollutants AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of availability. SUMMARY: This notice announces the availability of a final technical report titled, The Foundation for Global Action on Persistent Organic Pollutants: A United States Perspective (EPA/ 600/ P– 01/ 003F, March 2002), which was prepared by the Office of Research and Development's (ORD) National Center for Environmental Assessment (NCEA). The purpose of this report is to inform decision makers, general academia, and the public on the scientific foundation and relevance to the United States of the Stockholm Convention on Persistent Organic Pollutants (POPs). ADDRESSES: The document is available electronically on NCEA's Web site at www. epa. gov/ ncea, under the What's New or Publications menus. The CD– ROM version and a limited number of paper copies will be available shortly from the EPA's National Service Center for Environmental Publications (NSCEP), PO Box 42419, Cincinnati, OH 45242; telephone: 1– 800– 490– 9198 or 513– 489– 8190; facsimile: 513– 489– 8695. Please provide your name and mailing address and the title and EPA number of the requested publication. FOR FURTHER INFORMATION CONTACT: For further information on The Foundation for Global Action on Persistent Organic Pollutants: A United States Perspective, please contact Dr. Bruce Rodan, National Center for Environmental Assessment (8601D), U. S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; Telephone: 202– 564– 3329; facsimile: (202) 565– 0090; e­ mail: rodan. bruce@ epa. gov; or the Technical Information Staff, National Center for Environmental Assessment/ Washington Office (8623D), U. S. Environmental Protection Agency, VerDate May< 23> 2002 14: 07 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 13JNN1. SGM pfrm17 PsN: 13JNN1

epa

2024-06-07T20:31:41.806832

regulations

EPA-HQ-OPP-2002-0069-0003

Notice

Methodology for Lower Toxicity Pesticide Chemicals; Notice of Availability . Extension of Comment Period

55252 Federal Register / Vol. 67, No. 167 / Wednesday, August 28, 2002 / Notices ENVIRONMENTAL PROTECTION AGENCY [OPP– 2002– 0069; FRL– 7197– 4] Methodology for Lower Toxicity Pesticide Chemicals; Extension of Comment Period AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of Availability; Extension of Comment Period. SUMMARY: On June 13, 2002, EPA published a notice of availability soliciting comments on a document `` methodlogy for determining the data needed and the types of assessments necessary to make FFDCA section 408 safety determinations for lower toxicity pesticide chemicals. '' EPA is extending the comment period for 30 days, from September 11, 2002, to October 11, 2002. DATES: Comments, identified by the docket ID number OPP– 2002– 0069, must be received on or before October 11, 2002. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP– 2002– 0069 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305– 6304; fax number: (703) 305– 0599; e­ mail address: boyle. kathryn@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. This action may, however, be of interest to those persons who are or may be required to conduct testing of chemical substances­ under the Federal Food, Drug, and Cosmetic Act (FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)]. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. On the Home Page select `` Laws and Regulations, '' `` Regulations and Proposed Rules, '' and then look up the entry for this document under the `` Federal Register— Environmental Documents. '' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. To obtain an electronic copy of the methodology, go to www. epa. gov/ oppfead1/ cb/ csb page/ updates/ lowertox. pdf . 2. In person. The Agency has established an official record for this action under docket ID number OPP– 2002– 0069. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305– 5805. C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP– 2002– 0069 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305– 5805. 3. Electronically. You may submit your comments electronically by e­ mail to: opp­ docket@ epa. gov, or you can submit a computer disk as described in this unit. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in WordPerfect 6.1/ 8.0/ 9.0 or ASCII file format. All comments in electronic form must be identified by docket ID number OPP– 2002– 0069. Electronic comments may also be filed online at many Federal Depository Libraries. D. How Should I Handle CBI that I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. VerDate Aug< 23> 2002 14: 18 Aug 27, 2002 Jkt 197001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 28AUN1. SGM 28AUN1 55253 Federal Register / Vol. 67, No. 167 / Wednesday, August 28, 2002 / Notices 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the notice or collection activity. 7. Make sure to submit your comments by the deadline in this notice. 8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. What Action is EPA Taking? In the Federal Register of June 13, 2002 (67 FR 40732) (FRL– 7177– 9), EPA published a notice of availability soliciting comments on a document `` methodology for determing the data needed and the types of assessments necessary to make FFDCA section 408 safety determinations for lower toxicity pesticide chemicals. '' In response to a request for an extension, EPA is extending the comment period for 30 days, from September 11, 2002 to October 11, 2002. The methodology is available on the Agency's Web site at www. epa. gov/ oppfead1/ cb/ csb page/ updates/ lowertox. pdf. List of Subjects Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests. Dated: August 22, 2002. Deborah Edwards, Acting Director, Registration Division, Office of Pesticide Programs. [FR Doc. 02– 21937 Filed 8– 27– 02; 8: 45 am] BILLING CODE 6560– 50– S ENVIRONMENTAL PROTECTION AGENCY [OPP– 2002– 0165; FRL– 7190– 5] Pesticides; Guidance for Pesticide Registrants on Submitting Requests for Threshold of Regulation (TOR) Decisions and Standard Operating Procedures (SOP) for Making TOR Decisions AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The Agency is announcing the availability of Pesticide Registration Notice 2002– 2 (PR­ Notice) Entitled `` Guidance for Submitting Requests for Threshold of Regulation (TOR) Decisions. '' The Office of Pesticide Programs (OPP) issues PR­ Notices to inform pesticide registrants and other interested persons about important policies, procedures and registrationrelated decisions and to provide guidance to pesticide registrants and OPP personnel. PR­ Notice 2002– 2 provides guidance concerning procedures to use when a registrant or other person wants the Agency to determine whether a use of a pesticide in a manner that has the possibility of resulting in residues in food qualifies under the Agency's October 27, 1999 `` Threshold of Regulation'' policy. If EPA concludes a use is below the threshold of regulation, no tolerance or tolerance exemption would be required. The accompanying SOP explains how the Agency will process TOR requests. FOR FURTHER INFORMATION CONTACT: Vivian Prunier, Field and External Affairs Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308– 9341; fax number: (703) 305– 5884; e­ mail address: Prunier. Vivian@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. This action may, however, be of interest to those persons who are required to register pesticides under the Federal Fungicide, Insecticide and Rodenticide Act (FIFRA) or to persons who may be interested in ascertaining whether a tolerance or tolerance exemption is required under the Federal Food, Drug and Cosmetic Act (FFDCA) as a condition of FIFRA registration of a pesticide. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations, '' `` Regulations and Proposed Rules, '' and then look up the entry for this document under the `` Federal Register— Environmental Documents. '' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. You may view the PR Notice and the SOP described in this notice on the Office of Pesticide Programs Internet Home Page at http:// www. epa. gov/ opppmsd1/ PR Notices/. 2. In person. The Agency has established an official record for this action under docket ID number OPP– 2002– 0165. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305– 5805. II. Background In the Federal Register of October 27, 1999 (64 FR 57881), the Environmental Protection Agency (EPA) announced the availability of a document entitled `` Threshold of Regulation Policy — Deciding Whether a Pesticide with a Food Use Pattern Needs a Tolerance. '' The Threshold of Regulation (TOR) policy listed criteria and procedures for considering whether a tolerance is required for the use of a pesticide. A use may qualify as a TOR use if: (a) Using a reliable and appropriately sensitive analytical method to measure residues in the commodity, no residues are detected in the commodity under the expected conditions of use; and (b) using reasonably protective criteria, the estimated potential risk of any theoretically possible residues in food is not of concern. In the Federal Register of October 5, 2001 (55 FR 51040), the Agency announced the availability of, and asked for comments on, a draft PR­ Notice entitled `` Guidance for Submitting Requests for Threshold of Regulation (TOR) Decisions. '' The draft PR­ Notice would provide guidance on how to submit a request for a TOR decision and would explain how EPA will make TOR decisions in the course of pesticide VerDate Aug< 23> 2002 14: 18 Aug 27, 2002 Jkt 197001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 28AUN1. SGM 28AUN1

epa

2024-06-07T20:31:41.811410

regulations

EPA-HQ-OPP-2002-0071-0001

Notice

Terrestrial Field Dissipation Workshop; Notice.

[ Federal Register: June 12, 2002 ( Volume 67, Number 113)] [ Notices] [ Page 40290] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr12jn02­ 68] ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ENVIRONMENTAL PROTECTION AGENCY [ OPP­ 2002­ 0071; FRL­ 7176­ 3] Terrestrial Field Dissipation Workshop; Notice AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ SUMMARY: EPA and Canada's Pesticide Management Regulatory Agency ( PMRA) will hold a 3­ day workshop to discuss a proposed harmonized pesticide guideline for terrestrial field dissipation studies beginning on July 23, 2002, and ending on July 25, 2002. This notice announces the location and times for the workshop and sets forth the tentative agenda topics. DATES: The workshop meetings will be held on Tuesday, July 23, 2002, and Wednesday, July 24, 2002, from 9 a. m. to 5 p. m., and Thursday, July 25, 2002, 9 a. m. to noon. The meetings on July 23 and July 25 2002, are open to the public. The meeting on July 24, 2002, is an internal meeting. ADDRESSES: The workshop will be held at the Double Tree Hotel, Crystal City, 300 Army Navy Drive, Arlington, VA 22202. Space is limited. FOR FURTHER INFORMATION CONTACT: Mark Corbin, Environmental Fate and Effects Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: ( 703) 605­ 0033; fax number: ( 703) 305­ 6309; e­ mail address: corbin. mark@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does This Action Apply to Me? This action is directed to the public in general. This action may, however, be of interest to pesticide registrants and to all others who are involved in pesticide matters. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of This Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document on the Home Page, select Laws and Regulations,'' Regulations and Proposed Rules,'' and then look up the entry for this document under the Federal Register''­­ Environmental Documents. You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. For additional information on the goals, purpose, and agenda for the terrestrial field dissipation workshop, refer to the following Web site: http:// esc. syrres. com/ fdw/. 2. In person. The Agency has established an administrative record for this workshop under docket control number OPP­ 2002­ 0071. The administrative record consists of the documents specifically referenced in this notice, any public comments received during an applicable comment period, and other information related to the workshop. This administrative record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the administrative record, which includes printed, paper versions of any period, is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305­ 5805. C. Goals/ Purpose/ Agenda The goals of the workshop include the following: 1. Resolve Science Advisory Panel issues and industry ( Crop Life America/ Crop Life Canada) comments on the 1998 draft harmonized guidelines/ protocol. 2. Involve industry, government, academic, and other interested parties in providing feedback on and obtaining resolution of the remaining issues pertaining to the revised guidelines/ protocol. 3. Finalize the harmonized guidelines/ protocol. List of Subjects Environmental protection. Dated: June 6, 2002. Elizabeth Leovey, Acting Director, Environmental Fate and Effects Division, Office of Pesticide Programs. [ FR Doc. 02­ 14771 Filed 6­ 11­ 02; 8: 45 am] BILLING CODE 6560­ 50­ S

epa

2024-06-07T20:31:41.814073

regulations

EPA-HQ-OPP-2002-0077-0001

Notice

Notice of Receipt of Requests to Voluntarily Cancel Certain Pesticide Registrations.

[ Federal Register: June 3, 2002 ( Volume 67, Number 106)] [ Notices] [ Page 38272­ 38276] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr03jn02­ 50] ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ENVIRONMENTAL PROTECTION AGENCY [ OPP­ 2002­ 0077; FRL­ 7179­ 8] Notice of Receipt of Requests to Voluntarily Cancel Certain Pesticide Registrations AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ SUMMARY: In accordance with section 6( f)( 1) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), as amended, EPA is issuing a notice of receipt of request by registrants to voluntarily cancel certain pesticide registrations. DATES: Unless a request is withdrawn, the Agency will approve these use deletions and the deletions will become effective on December 2, 2002. FOR FURTHER INFORMATION CONTACT: By mail: James A. Hollins, Information Resources Services Division 7502C, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 305­ 5761; e­ mail address: hollins. james@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. Although this action may be of particular interest to persons who produce or use pesticides, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the information in this notice, consult the person listed under FOR FURTHERINFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select Laws and Regulations,'' Regulations and Proposed Rules,'' and then look up the entry for this document under the Federal Register­­ Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. II. What Action is the Agency Taking? This notice announces receipt by the Agency of applications from registrants to cancel 67 pesticide products registered under section 3 or 24( c) of FIFRA. These registrations are listed in sequence by registration number ( or company number and 24( c) number) in Table 1 of this unit: Table 1.­­ Registrations With Pending Requests for Cancellation ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Registration no. Product Name Chemical Name ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000052­ 00208 Germ Warfare Concentrated Sodium 2­ benzyl­ 4­ chlorophenate Detergent Germicide Sodium o­ phenylphenate p­ tert­ Amylphenol, sodium salt ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000100­ 01019 Eptam 2.3 G S­ Ethyl dipropylthiocarbamate ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000100 FL­ 89­ 0025 D. Z. N. Diazinon AG 500 O, O­ Diethyl O­( 2­ isopropyl­ 6­ methyl­ 4­ pyrimidinyl) phosphorothioate ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000100 FL­ 90­ 0002 Pennant Liquid Herbicide 2­ Chloro­ N­( 2­ ethyl­ 6­ methylphenyl)­ N­ ( 2­ methoxy­ 1­ methylphenyl) acetamide ( 9CI) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ [[ Page 38273]] 000192­ 00195 Dexol Lawn & Garden Tetrachloroisophthalonitrile Fungicide with Daconil 2787 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000241 OR­ 00­ 0031 Raptor Herbicide (+­)­ 2­( 4,5­ Dihydro­ 4­ methyl­ 4­( 1­ methylethyl)­ 5­ oxo­ 1H­ imidazol­ 2­ ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000264­ 00639 Brestan H 47.5 WP Fungicide Triphenyltin hydroxide ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000264 OR­ 94­ 0014 Dodine 65W Dodecylguanidine acetate ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000264 WA­ 93­ 0011 Nortron Flowable Herbicide 2­ Ethoxy­ 2,3­ dihydro­ 3,3­ dimethyl­ 5­ benzofuranyl methanesulfonate, (+­)­ ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000264 WA­ 95­ 0020 Nortron Flowable Herbicide 2­ Ethoxy­ 2,3­ dihydro­ 3,3­ dimethyl­ 5­ benzofuranyl methanesulfonate, (+­)­ ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000279 FL­ 77­ 0039 Niagara Ethion 4 Miscible O, O, O', O'­ Tetraethyl S, S'­ methylene Miticide Insecticide bis( phosphorodithioate) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000432 OR­ 96­ 0022 Acclaim 1EC Herbicide 2­( 4­(( 6­ Chloro­ 2­ benzoxazolyl) oxy) phenoxy) propionic acid, ethyl ester, (+­)­ ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000524 ND­ 99­ 0013 MON­ 65005 Herbicide Isopropylamine glyphosate ( N­ ( phosphonomethyl) glycine) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000675­ 00025 Amphyl Disinfectant Ethanol Deodorant Spray o­ Phenylphenol ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000675­ 00046 New O­ Syl Disinfectant ­ 2­ Benzyl­ 4­ chlorophenol Detergent o­ Phenylphenol ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000769­ 00633 Smcp Ethion EM­ 4 O, O, O', O'­ Tetraethyl S, S'­ methylene bis( phosphorodithioate) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 001769­ 00174 Watrol 6,7­ Dihydrodipyrido( 1,2­ a: 2', 1'­ c) pyrazinediium dibromide ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 002517­ 00060 Sergeant's Dual Action Flea o­ Isopropoxyphenyl methylcarbamate and Tick Collar for Dogs 2,2­ Dichlorovinyl dimethyl phosphate ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 002935 OR­ 97­ 0003 Orthene 75 S Soluble Powder O, S­ Dimethyl acetylphosphoramidothioate ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 003125­ 00173 Di­ Syston Seed Treatment O, O­ Diethyl S­( 2­( ethylthio) ethyl) Insecticide phosphorodithioate ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 003125 ID­ 99­ 0001 Admire 2 Flowable 1­(( 6­ Chloro­ 3­ pyridinyl) methyl)­ N­ nitro­ 2­ imidazolidinimine ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 003862­ 00118 Di­ Elec Wasp & Hornet Spray ( Butylcarbityl)( 6­ propylpiperonyl) ether 80% and related compounds20% Bendiocarb ( 2,2­ dimethyl­ 1,3­ benzoldioxol­ 4­ yl methylcarbamate) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 005481­ 00270 AMVAC Ethion 4 Miscible for O, O, O', O'­ Tetraethyl S, S'­ methylene Citrus bis( phosphorodithioate) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007173­ 00080 Rozol Ready­ To­ Use Rat and 2­(( p­ Chlorophenyl) phenylacetyl)­ 1,3­ Mouse Bait indandione ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007173­ 00128 Rozol Rat and Mouse Killer 2­(( p­ Chlorophenyl) phenylacetyl)­ 1,3­ indandione ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007173­ 00161 Rozol Rat and Mouse Killer 2­(( p­ Chlorophenyl) phenylacetyl)­ 1,3­ Pellets indandione ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007173­ 00171 Maki Rat and Mouse Meal Bait 3­( 3­( 4'­ Bromo­( 1,1'­ biphenyl)­ 4­ yl)­ 3­ hydroxy­ 1­ phenylpropyl)­ 4­ hydroxy­ 2H­ 1­ ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007173­ 00184 Rozol Pocket Gopher Bait 2­(( p­ Chlorophenyl) phenylacetyl)­ 1,3­ indandione ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007173­ 00186 Maki Rat and Mouse Meal Bait 3­( 3­( 4'­ Bromo­( 1,1'­ biphenyl)­ 4­ yl)­ 3­ hydroxy­ 1­ phenylpropyl)­ 4­ hydroxy­ 2H­ 1­ ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007173­ 00190 Rozol Paraffin Blocks 2­(( p­ Chlorophenyl) phenylacetyl)­ 1,3­ indandione ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007173­ 00195 Ridall­ Zinc Rodent Field & Zinc phosphide ( Zn3P2) Agricultural Bait ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007173 AZ­ 77­ 0006 Rozol Ground Squirrel Bait 2­(( p­ Chlorophenyl) phenylacetyl)­ 1,3­ indandione ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007173 ID­ 92­ 0003 Rozol Paraffinized Pellets 2­(( p­ Chlorophenyl) phenylacetyl)­ 1,3­ indandione ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007173 OR­ 78­ 0018 Rozol Rodenticide Ground 2­(( p­ Chlorophenyl) phenylacetyl)­ 1,3­ Spray Concentrate indandione ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007173 UT­ 77­ 0001 Rozol Paraffinized Pellets 2­(( p­ Chlorophenyl) phenylacetyl)­ 1,3­ indandione ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ [[ Page 38274]] 007173 UT­ 78­ 0006 Rozol Rodenticide Ground 2­(( p­ Chlorophenyl) phenylacetyl)­ 1,3­ Spray Concentrate indandione ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007173 WA­ 78­ 0060 Rozol Rodenticide Ground 2­(( p­ Chlorophenyl) phenylacetyl)­ 1,3­ Spray Concentrate indandione ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007173 WV­ 77­ 0003 Rodenticide Ground Spray 2­(( p­ Chlorophenyl) phenylacetyl)­ 1,3­ Concentrate indandione ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007401­ 00113 Ferti­ Lome Citrus & O, O, O', O'­ Tetraethyl S, S'­ methylene Ornamental Spray bis( phosphorodithioate) Aliphatic petroleum hydrocarbons ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007501­ 00098 Gustafson 2% Reldan Dust O, O­ Dimethyl O­( 3,5,6­ trichloro­ 2­ Insecticide pyridyl) phosophorothioate ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007501­ 00099 Gustafson 3% Reldan Dust O, O­ Dimethyl O­( 3,5,6­ trichloro­ 2­ Insecticide pyridyl) phosophorothioate ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007501 ID­ 99­ 0002 Gaucho 75 St Insecticide 1­(( 6­ Chloro­ 3­ pyridinyl) methyl)­ N­ nitro­ 2­ imidazolidinimine ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007501 ID­ 99­ 0005 MZ ­ Curzate Gas cartidge ( as a device for burrowing animal control) Zinc ion and manganese ethylenebisdithiocarbamate, coordination product 2­ Cyano­ N­(( ethylamino) carbonyl)­ 2­ ( methoxyimino) acetamide ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007501 NE­ 00­ 0001 Evolve Potato Seed­ Piece Zinc ion and manganese Treatment ethylenebisdithiocarbamate, coordinationproduct Dimethyl (( 1,2­ phenylene) bis( iminocarbonothioyl)) bis( carbamate) 2­ Cyano­ N­(( ethylamino) carbonyl)­ 2­ ( methoxyimino) acetamide ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007501 NE­ 01­ 0001 Tops­ MZ­ Gaucho Gas cartidge ( as a device for burrowing animal control) Zinc ion and manganese ethylenebisdithiocarbamate, coordination product Dimethyl (( 1,2­ phenylene) bis( iminocarbonothioyl)) bis( carbamate) 1­(( 6­ Chloro­ 3­ pyridinyl) methyl)­ N­ nitro­ 2­ imidazolidinimine ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007501 NE­ 99­ 0004 MZ ­ Curzate Potato Seed­ Gas cartidge ( as a device for burrowing Piece Treatment animal control) Zinc ion and manganese ethylenebisdithiocarbamate, coordination product 2­ Cyano­ N­(( ethylamino) carbonyl)­ 2­ ( methoxyimino) acetamide ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007501 WA­ 99­ 0004 Tops ­ MZ ­ Gaucho Potato Gas cartidge ( as a device for burrowing Seed­ Piece Treatment animal control) Zinc ion and manganese ethylenebisdithiocarbamate, coordination product Dimethyl (( 1,2­ phenylene) bis( iminocarbonothioyl)) bis( carbamate) 1­(( 6­ Chloro­ 3­ pyridinyl) methyl)­ N­ nitro­ 2­ imidazolidinimine ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007501 WA­ 99­ 0011 Tops ­ MZ ­ CZ Gas cartidge ( as a device for burrowing animal control) Zinc ion and manganese ethylenebisdithiocarbamate, coordination product Dimethyl (( 1,2­ phenylene) bis( iminocarbonothioyl)) bis( carbamate) 2­ Cyano­ N­(( ethylamino) carbonyl)­ 2­ ( methoxyimino) acetamide ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 008536 FL­ 97­ 0006 Methyl Bromide 98% Methyl bromide ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 009198­ 00122 The Andersons Turcam Bendiocarb ( 2,2­ dimethyl­ 1,3­ Insecticide I benzoldioxol­ 4­ yl methylcarbamate) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 009688­ 00118 Chemsico Granules Formula B Bendiocarb ( 2,2­ dimethyl­ 1,3­ benzoldioxol­ 4­ yl methylcarbamate) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 010145­ 00007 Vita­ San WS 2­ Benzyl­ 4­ chlorophenol Sodium o­ phenylphenate ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 010163­ 00080 Gowan Azinphos­ M 2 EC O, O­ Dimethyl S­(( 4­ oxo­ 1,2,3­ benzotriazin­ 3( 4H)­ yl) methyl) phosphorodithioate ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 010163 OR­ 94­ 0045 Imidan 70­ WP Agricultural N­( Mercaptomethyl) phthalimide S­( O, O­ Insecticide dimethyl phosphorodithioate) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 010163 OR­ 94­ 0047 Imidan 70­ WP Agricultural N­( Mercaptomethyl) phthalimide S­( O, O­ Insecticide dimethyl phosphorodithioate) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 010807­ 00095 Pine Oil Disinfectant Pine oil ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 045639 OR­ 00­ 0009 Hoelon 3EW Herbicide Methyl 2­( 2­( 2,4­ dichlorophenoxy) phenoxy) propanoate ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ [[ Page 38275]] 048598­ 00003 Insecto Formula 7 Pine oil ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 051036 AZ­ 89­ 0011 Dimethoate 4E Systemic O, O­ Dimethyl S­ Insecticide (( methylcarbamoyl) methyl) phosphorodithioate ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 051161 OR­ 93­ 0013 Orthene 75 S Soluble Powder O, S­ Dimethyl acetylphosphoramidothioate ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 054555 TX­ 00­ 0001 Dormex Cyanamide ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 062719­ 00404 Stampede CM Herbicide 3', 4'­ Dichloropropionanilide 2­ Ethylhexyl 2­ methyl­ 4­ chlorophenoxyacetate ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 067752 OR­ 93­ 0014 Orthene 75 S Soluble Powder O, S­ Dimethyl acetylphosphoramidothioate ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 071368 WA­ 80­ 0081 Weedar 64 Broad Leaf Dimethylamine 2,4­ Herbicide dichlorophenoxyacetate ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 071368 WA­ 85­ 0021 Weedar 64 Broad Leaf Dimethylamine 2,4­ Herbicide dichlorophenoxyacetate ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 071368 WA­ 95­ 0037 Weedar 64 ( R) Broadleaf Dimethylamine 2,4­ Herbicide dichlorophenoxyacetate ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 071768­ 00001 Bear Pause Attack Deterrent Capsaicin ( in oleoresin of capsicum) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ There is a 30­ day comment period on registrations for EPA companynumbers 000279, 005481, 071768. Unless a request is withdrawn by the registrant within 180 days of publication of this notice, orders will be issued canceling all of these registrations. Users of these pesticides or anyone else desiring the retention of a registration should contact the applicable registrant directly during this 180­ day period. Table 2 of this unit includes the names and addresses of record for all registrants of the products in Table 1 of this unit, in sequence by EPA company number: Table 2.­­ Registrants Requesting Voluntary Cancellation ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ EPA Company no. Company Name and Address ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000052 W. P. Chemical Products, Inc., W. Penetone Corp., 74 Hudson Ave., Tenafly, NJ 07670. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000100 Syngenta Crop Protection, Inc., Box 18300, Greensboro, NC 27419. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000192 Value Gardens Supply, LLC, Box 585, St. Joseph, MO 64502. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000241 BASF Corp., Box 13528, Research Triangle Park, NC 27709. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000264 Aventis Cropscience USA LP, 2 T. W. Alexander Drive Box 12014, Research Triangle Park, NC 27709. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000279 FMC Corp. Agricultural Products Group, 1735 Market St., Philadelphia, PA 19103. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000432 Aventis Environmental Science USA LP, 95 Chestnut Ridge Rd., Montvale, NJ 07645. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000524 Monsanto Co., 600 13th Street, NW, Suite 660, Washington, DC 20005. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000675 Reckitt Benckiser Inc., 1655 Valley Rd., Wayne, NJ 07474. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 000769 Value Gardens Supply, LLC, Box 585, St. Joseph, MO 64502. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 001769 NCH Corp., 2727 Chemsearch Blvd., Irving, TX 75062. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 002517 Sergeant's Pet Products, Box 18993, Memphis, TN 38181. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 002935 Wilbur Ellis Co., 191 W. Shaw Ave, i107, Fresno, CA 93704. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 003125 Bayer Corp., Agriculture Division, 8400 Hawthorn Rd., Box 4913, Kansas City, MO 64120. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 003862 ABC Compounding Co, Inc., Box 16247, Atlanta, GA 30321. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 005481 AMVAC Chemical Corp., Attn: Jon C. Wood, 4695 Macarthur Ct., Suite 1250, Newport Beach, CA 92660. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007173 LiphaTech, Inc., 3600 W. Elm Street, Milwaukee, WI 53209. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007401 Brazos Associates, Inc., Agent For: Voluntary Purchasing Group Inc., 2001 Diamond Ridge Drive, Carrollton, TX 75010. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 007501 Gustafson LLC, 1400 Preston Rd., Suite 400, Planos, TX 75093. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ [[ Page 38276]] 008536 Soil Chemicals Corp., D/ b/ a Cardinal Professional Products, Box 782, Hollister, CA 95024. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 009198 The Andersons Inc., Lawn Fertilizer Division, Box 119, Maumee, OH 43537. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 009688 Chemsico, Div of United Industries Corp., Box 142642, St Louis, MO 63114. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 010145 Blumberg Co. Inc., Box 1329, Newburyport, MA 01950. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 010163 Gowan Co., Box 5569, Yuma, AZ 85366. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 010807 AMREP, Inc., 990 Industrial Dr, Marietta, GA 30062. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 045639 Agrevo USA Co., Little Falls Centre One, 2711 Centerville Rd., Wilmington, DE 19808. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 048598 Natural Insecto Products, Inc., 221 Sherwood Place, Box 12138, Costa Mesa, CA 92627. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 051036 Micro­ Flo Co. LLC, Box 772099, Memphis, TN 38117. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 051161 Round Butte Seed Growers Inc., 505 C Street, Box 117, Culver, OR 97734. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 054555 Siemer & Associates, Inc., Agent For: Degussa Ag., 4672 W. Jennifer, Suite 103, Fresno, CA 93722. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 062719 Dow AgroSciences LLC, 9330 Zionsville Rd., 308/ 2E225, Indianapolis, IN 46268. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 067752 Central Oregon Seed Inc., 1747 NW Mill St., Madras, OR 97741. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 071368 Nufarm, Inc., 500 Lower Lake Rd., St. Joseph, MO 64504. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 071768 Chemarmor, 625 North Ave. W., Box 4363, Missoula, MT 59806. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ III. What is the Agency's Authority for Taking this Action? Section 6( f)( 1) of FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register. Thereafter, the Administrator may approve such a request. IV. Procedures for Withdrawal of Request Registrants who choose to withdraw a request for cancellation must submit such withdrawal in writing to the person listed under FOR FURTHER INFORMATION CONTACT, postmarked before December 2, 2002. This written withdrawal of the request for cancellation will apply only to the applicable FIFRA section 6( f)( 1) request listed in this notice. If the product( s) have been subject to a previous cancellation action, the effective date of cancellation and all other provisions of any earlier cancellation action are controlling. The withdrawal request must also include a commitment to pay any reregistration fees due, and to fulfill any applicable unsatisfied data requirements. V. Provisions for Disposition of Existing Stocks The effective date of cancellation will be the date of the cancellation order. The orders effecting these requested cancellations will generally permit a registrant to sell or distribute existing stocks for 1 year after the date the cancellation request was received. This policy is in accordance with the Agency's statement of policy as prescribed in the FederalRegister of June 26, 1991 ( 56 FR 29362) ( FRL­ 3846­ 4). Exceptions to this general rule will be made if a product poses a risk concern, or is in noncompliance with reregistration requirements, or is subject to a data call­ in. In all cases, product­ specific disposition dates will be given in the cancellation orders. Existing stocks are those stocks of registered pesticide products which are currently in the United States and which have been packaged, labeled, and released for shipment prior to the effective date of the cancellation action. Unless the provisions of an earlier order apply, existing stocks already in the hands of dealers or users can be distributed, sold, or used legally until they are exhausted, provided that such further sale and use comply with the EPA­ approved label and labeling of the affected product. Exception to these general rules will be made in specific cases when more stringent restrictions on sale, distribution, or use of the products or their ingredients have already been imposed, as in a Special Review action, or where the Agency has identified significant potential risk concerns associated with a particular chemical. List of Subjects Environmental protection, Pesticides and pests. Dated: May 14, 2002. Linda Vlier Moos, Acting Director, Information Resources Services Division, Office of Pesticide Programs. [ FR Doc. 02­ 13811 Filed 5­ 31­ 02; 8: 45 am] BILLING CODE 6560­ 50­ S

epa

2024-06-07T20:31:41.817488

regulations

EPA-HQ-OPP-2002-0078-0001

Proposed Rule

Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food.

[ Federal Register: June 3, 2002 ( Volume 67, Number 106)] [ Notices] [ Page 38276­ 38279] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr03jn02­ 51] ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ENVIRONMENTAL PROTECTION AGENCY [ OPP­ 2002­ 0078; FRL­ 7179­ 2] Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain [[ Page 38277]] pesticide chemical in or on various food commodities. DATES: Comments, identified by docket control number OPP­ 2002­ 0078, must be received on or before July 3, 2002. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. C. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP­ 2002­ 0078 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: Shaja Brothers, Registration Support Branch, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 308­ 3194 and e­ mail address: brothers. shaja@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Examples of Categories NAICS codes potentially affected entities ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select Laws and Regulations,'' Regulations and Proposed Rules,'' and then look up the entry for this document under the Federal Register''­­ Environmental Documents. You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. 2. In person. The Agency has established an official record for this action under docket control number OPP­ 2002­ 0078 official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall i2, 1921 Jefferson Davis Highway, Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305­ 5805. C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP­ 2002­ 0078 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall i2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305­ 5805. 3. Electronically. You may submit your comments electronically by e­ mail to: opp­ docket@ epa. gov, or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in Wordperfect 6.1/ 8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP­ 2002­ 0078. Electronic comments may also be filed online at many Federal Depository Libraries. D. How Should I Handle CBI That I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your [[ Page 38278]] response. You may also provide the name, date, and Federal Register citation. II. What Action is the Agency Taking? EPA has received a pesticide petition as follows proposing the establishment and/ or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in section 408( d)( 2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition. List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 17,2002. Robert Forrest, Acting Director, Registration Division, Office of Pesticide Programs. Summary of Petition The petitioner summary of the pesticide petition is printed below as required by section 408( d)( 3) of the FFDCA. The summary of the petition was prepared by the Interregional Research Project Number 4, and represents the view of the Interreional Research Project. EPA is publishing the petition summary verbatim without editing it in any way. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed. PP 1E6322 EPA has received a pesticide petition ( 1E6322) from the Interregional Research Project Number 4, 681 U. S. Highway 1 South, North Brunswick, New Jersey 08902­ 3390] proposing, pursuant to section 408( d) of the FFDCA, 21 U. S. C. 346a( d), to amend 40 CFR 180.479 by establishing a tolerance for residues of the herbicide [ halosulfuron, methyl 5­[( 4,6­ dimethoxy­ 2­ pyrimidinyl) amino] carbonylaminosulfonyl­ 3­ chloro­ 1­ methyl­ 1H­ pyrazole­ 4­ carboxylate] in or on the raw agricultural commodities ( RAC) dry bean and succulent snap bean at 0.05 parts per million ( ppm). EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition. This notice includes a summary of the petition prepared by Gowan Company, Yuma, Arizona 85366. A. Residue Chemistry 1. Plant metabolism. The metabolism of halosulfuron­ methyl as well as the nature of the residues in plants is adequately understood for purposes of this tolerance. 2. Analytical method. A practical analytical method, gas chromatography with a nitrogen specific detector ( TSD) which detects and measures residues of halosulfuron­ methyl, is available for enforcement purposes with a limit of detection that allows monitoring of food with residues at or above the levels set in these tolerances. This enforcement method has been submitted to the Food and Drug Administration for publication in the Pesticide Analytical Manual ( PAM II). It has undergone independent laboratory validation and validation at the Beltsville laboratory. 3. Magnitude of residues. In snap and dry bean residue studies, there were no quantifiable residues found in the RAC using an analytical method with limit of quantitation ( LOQ) of 0.05 ppm. B. Toxicological Profile The nature of the toxic effects caused by halosulfuron­ methyl is discussed in unit II. B of the Federal Register on April 31, 2001 ( 66 FR 45993) ( FRL­ 6796­ 1). C. Aggregate Exposure 1. Dietary exposure. Tolerances have been established ( 40 CFR 180.479) for residues of halosulfuron­ methyl in or on a variety of plant and animal RACs. i. Food­­ a. Acute exposure. For purposes of assessing the potential dietary exposure from food under existing and proposed tolerances, the aggregate exposure is based on the Theoretical Maximum Residue Contribution ( TMRC) which is an estimate of the level of residues consumed daily if each food item contained pesticide residues equal to the tolerance. The calculated TMRC value using the 99.9th percentile consumption data was 0.006 milligrams/ kilograms bodyweight day ( mg/ kg bwt day) or 1.2% acute Reference Dose ( aRfD) for the general U. S. population. TMRC is obtained by multiplying the tolerance levels for each commodity by the daily consumption of the food forms of that commodity eaten by the U. S. population and various population subgroups. In conducting this exposure assessment, conservative assumptions were made resulting in a large overestimate of human exposure. Thus, the dietary exposures to halosulfuron­ methyl are less 3.0% aRfD for all sub­ populations. Food consumption data from DEEM software were used in the calculation. b. Chronic exposure. The chronic Reference Dose ( cRfD) is 0.1 mg/ kg/ day. For all established and proposed tolerances of halosulfuron­ methyl, the calculated TMRC value for the U. S. population is 0.00049 mg/ kg/ day or 0.5% RfD. ii. Drinking water. The estimated environmental concentrations ( EECs) in ground water ( acute and chronic) is 0.008 [ mu] g/ L. The estimated EECs ( acute and chronic) for surface water are 4.3 [ mu] g/ L and 1.1 [ mu] g/ L, respectively. These estimates are based on a maximum application rate of 0.063 lbs. active per acre, which may be applied twice per season. There is no Maximum Contaminant Level ( MCL) established for residues of halosulfuron­ methyl. 2. Non­ dietary exposure. The non­ dietary exposure assessment for halosulfuron­ methyl is discussed in unit II. C of the Federal Register on April 31, 2001 ( 66 FR 45993) ( FRL­ 6796­ 1). D. Cumulative Effects The potential for cumulative effects for halosulfuron­ methyl is discussed in unit II. D of the Federal Register on April 31, 2001 ( 66 FR 45993) ( FRL­ 6796­ 1). E. Safety Determination 1. U. S. population. Aggregate chronic exposure to halosulfuron­ methyl from food only'' utilizes less than 1% of the chronic populated adjusted dose ( cPAD) for the most sensitive subgroup, children ( 1­ 6 years). The lowest drinking water level of concern ( DWLOC) calculated was 1,000 [ mu] g/ L for infants and children which is significantly higher than the EEC for chronic ground water ( 0.008 [ mu] g/ L) and surface water ( 1.1 [ mu] g/ L). As a result, the aggregate risk from chronic exposure to halosulfuron­ methyl residues from all anticipated dietary exposures does not pose appreciable risks to human health. Short­ term risk­­ short­ term aggregate exposure takes into account chronic dietary food and water plus short­ term residential exposure. For halosulfuron­ methyl, the EPA has determined that it is appropriate to aggregate exposure via [[ Page 38279]] oral exposure route ( food and water) with those via oral and dermal exposure routes from residential uses. The MOEs for food only'' and residential exposure routes are 113, 600, and 330 for females 13+ years. Short­ term DWLOC for females 13+ is 10,000 [ mu] g/ L which is substantially higher than the EECs for acute surface water ( 4.3 [ mu] g/ L). The food only and residential ( oral and dermal) MOEs are well above the acceptable short­ term aggregate MOE of 100. Therefore, exposure to halosulfuron­ methyl residues resulting from current and proposed uses does not pose a short­ term aggregate risk. Intermediate­ term risk­­ intermediate­ term aggregate exposure takes into account chronic dietary food and water plus intermediate­ term residential exposure. The MOEs for food only'' and residential exposure routes are 22,800 and 120 for adult males, and 23,000 and 100 for females 13+ years. The intermediate­ term DWLOCs are 590 [ mu] g/ L and 57 [ mu] g/ L, respectively, for adult males and females 13+. Intermediate­ term DWLOCs are substantially higher than the EEC for chronic surface water ( 1.1 [ mu] g/ L). The food only and residential ( dermal) MOEs are above the acceptable short­ term aggregate MOE of 100. Therefore, exposure to halosulfuron­ methyl residues resulting from current and proposed uses does not pose a intermediate­ term aggregate risk. Halosulfuron­ methyl has been classified as a Group E chemical based upon the lack of evidence of carcinogenicity in mice and rats, and has been classified as not likely to be a human carcinogen. Therefore based upon this risk assessment, there is reasonable certainty that no harm will result from aggregate exposure to halosulfuron­ methyl residues resulting from current and proposed uses. 2. Infants and children. FFDCA section 408 provides that EPA may apply an additional safety factor ( up to 10) in the case of threshold effects for infants and children to account for pre­ natal and post­ natal toxicity and the completeness of the data base. Except for the pending request for a developmental neurotoxicity study, the toxicity data base is complete for halosulfuron­ methyl. The chronic RfD was determined to be 0.1 mg/ kg/ day based upon the chronic dog study. The percent of RfD occupied is 0.9% for the most sensitive population subgroup, children ( 1­ 6 years old). The DWLOC for chronic exposure for infants and children is 1,000 [ mu] g/ L and is significantly greater than the maximum concentration of halosulfuron­ methyl in drinking water ( 0.008 [ mu] g/ L in ground water and 1.1 [ mu] g/ L in surface water). Based upon reliable toxicity data, the use of an additional 10X safety factor is not warranted. Dietary assessments do not indicate a level of concern for potential risks to infants and children based upon the low use rates of halosulfuron­ methyl, and the results of field and animal RAC studies conclude that detectable residues are not expected in human foods. Therefore, based on complete and reliable toxicity data and the conservative exposure assessment, it is concluded that there is reasonable certainty that no harm will result to infants and children from aggregate exposure to halosulfuron­ methyl residues with respect to the proposed new uses on dry and succulent snap beans. F. International Tolerances Maximum residue levels have not been established for residues of halosulfuron­ methyl on any food or feed crop by the Codex Alimentarius Commission. [ FR Doc. 02­ 13814 Filed 5­ 31­ 02 8: 45 am] BILLING CODE 6560­ 50­ S

epa

2024-06-07T20:31:41.824296

regulations

EPA-HQ-OPP-2002-0079-0002

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM DATE: April 16, 2002 SUBJECT: HED Chapter for the Linuron Tolerance Reassessment Eligibility Decision PC Code: 035506. Case 0047. DP Barcode D271950 FROM: Carol Christensen, Risk Assessor Reregistration Branch II Health Effects Division (7509C) THRU: Al Nielsen, Branch Senior Scientist Reregistration Branch II Health Effects Division (7509C) TO: Dirk Helder Chemical Review Manager Special Review and Reregistration Division (7508C) The following human health risk assessment has been prepared by the Health Effects Division (HED) for Phase II­ Registrant Error Correction ­ of the tolerance reassessment process for linuron. The HED chapter reflects the Agency's current guidelines concerning the retention of the Food Quality Protection Act (FQPA) safety factor and risk assessment. The chapter is based upon the product chemistry review by Ken Dockter, the toxicology review by Robert Fricke, the residue chemistry and dietary exposure and risk analysis by John Punzi, the drinking water exposure assessment by Ibrahim Abdel­ Saheb of the Environmental Fate and Effects Division (EFED), and the incident review by Jerry Blondell. HED has acknowledged the Registrant's error­ only comments in this version of the risk assessment as well as in a separate Response to Comment document. This document includes corrections from John Punzi on residue chemistry and dietary risk assessment and Robert Fricke 2 concerning toxicology comments, as well as risk assessment and characterization corrections by Carol Christensen. Table of Contents 1.0 Executive Summary .......................................................... 3 2.0 Physical and Chemical Properties ................................................ 6 3.0 Hazard Characterization ....................................................... 7 3.1 Hazard Profile ........................................................ 7 3.2 FQPA Considerations ................................................. 19 3.3 Dose­ Response Assessment ............................................. 20 3.3.1 Acute Reference Dose (RfD) ­ Females 13­ 50 ..................... 23 3.3.2 Chronic Reference Dose (RfD) ................................... 24 3.4 Endocrine Disruption .................................................. 24 3.5 Potential Tetrachloroazobenzene Contamination .............................. 25 4.0 Exposure Assessment and Characterization ................................. 26 4.1 Summary of Registered Use Patterns ...................................... 26 4.2 Dietary (Food) Exposure/ Risk Pathway .................................... 27 4.2.1 Residue Profile ............................................... 27 4.2.2 Acute Dietary ­ Females 13­ 50 ................................... 30 4.2.3 Chronic Dietary ............................................... 32 4.3 Water Exposure/ Risk Pathway ........................................... 33 4.3.1 Environmental Fate ............................................ 34 4.3.2 Drinking Water Exposure Estimates ........................... 34 4.4 Residential Exposure/ Risk Pathway ....................................... 37 5.0 Aggregate Risk Assessment and Risk Characterization ............................... 38 5.1 Acute Risk .......................................................... 39 5.1.1 Acute Aggregate Risk Assessment (Females 13­ 50) ................... 39 5.1.2 Acute DWLOC Calculations ..................................... 40 5.2 Chronic Risk ........................................................ 40 5.2.1 Chronic Aggregate Risk Assessment ............................... 40 5.2.2 Chronic DWLOC Calculations ................................... 41 6.0 Cumulative Risk ............................................................ 41 7.0 Incident Data .............................................................. 42 3 8.0 Data Needs .............................................................. 43 References: .................................................................. 45 4 1.0 Executive Summary Linuron [3­( 3,4­ dichlorophenyl)­ 1­ methoxy­ 1­ methylurea] is a substituted urea, selective herbicide. Linuron is a systemic, photosynthesis inhibitor (Hill reaction) and controls a variety of weed species including annual morning glory, rye grass, and barnyard grass. Linuron may be applied preplant pre­ emergence, post­ emergence or post­ transplant and is registered for use on asparagus, carrots, celery, field and sweet corn, cotton, parsley, potatoes, sorghum, soybeans, and wheat. Linuron is formulated as an emulsifiable concentrate, flowable concentrate, water dispersible granules, and a wettable powder. The range of percentage of active ingredient in the end use product formulations is 40­ 50%. The application rates range from 0.5­ 4.0 lbs ai/ acre/ year and 1 or 2 applications are allowed per year. Linuron is mainly used in the early season and consequently has fairly long pre­ harvest intervals (PHIs), but a few crops have short PHIs, notably asparagus (1 day) and carrot (14 days). Linuron can be applied using ground or aerial equipment including band sprayer, boom sprayer, sprayer, sprinkler irrigation, and tractor mounted sprayer. There are 1.2 million pounds of linuron active ingredient used in the U. S. annually. Linuron has low acute toxicity (Toxicity Category III­ IV) by the oral, dermal and inhalation exposure routes. Primary eye and skin irritation studies with linuron were category III and IV, respectively. Linuron does not produce dermal sensitization. In chronic studies, linuron affects the hematopoetic system, the male reproductive system and the renal pelvis. Blood effects were seen in all species tested. Chronic toxicity studies in the dog, mouse and rat showed altered hematological findings. Beagles fed linuron displayed hemolytic anemia and secondary erythropogenic activity evidenced by slightly reduced hemoglobin, hematocrit, and erythrocyte counts accompanied by hemosiderin deposition in liver Kupffer cells and erythroid hyperplasia of bone marrow. Systemic toxicity observed in mice included increased methemoglobin formation and vacuolation and hemosiderosis of the spleen. In a chronic study in rats, microscopic observations consistent with hemolysis (hemosiderin in Kupffer cells and increased hemosiderosis in bone marrow, spleen, and/ or mesenteric lymph nodes) were seen. Other findings observed in the chronic rat study include, a significant decrease in body weight gain which persisted throughout the entire study, with females showing consistently lower body weight gain than males. The decreases in body weight gain correlated to some degree with decreased food consumption. Rats also showed an increased incidence of microscopic changes in the epididymides (perivasculitis/ vasculitis) and renal pelvis (transitional cell hyperplasia and mineralization/ calculi) of males and kidneys (calculi in renal tubules) of females. Developmental studies in the rat and rabbit showed no quantitative or qualitative susceptibility in the offspring. Effects seen include decreased body weight gain and food consumption, as well as increased postimplantation loss, fetal resorptions, fewer fetuses per litter, and decreased fetal body weight in rats, and an increased incidence of fetuses with skeletal skull variations in rabbits. These findings do not indicate increased susceptibility because increases in resorptions were marginal and there was no change in the number of live fetuses to corroborate the increases in post­ implantation losses. However, in a 2­ generation reproductive toxicity study using rats, linuron caused gross lesions of the 5 testes (including reduction in size), abnormally large, soft, and small epididymides, and unspecified deformities of the epididymides in F1 animals. These were all noted as significant incidences. A 3­ generation study using rats showed reduced body weights and fertility, decreased pup survival, and decreased weanling body, liver and kidney weights, as well as liver atrophy. The Hazard Identification Assessment Review Committee (HIARC) determined that these results illustrate qualitative susceptibility in the rat offspring. There is ample evidence from special studies submitted to the Agency by the registrant as well as open literature studies which indicate that linuron is an endocrine disruptor. These findings include, in part: (1) competitive androgen receptor antagonist; but not an estrogen receptor antagonist; (2) competitive inhibition of the transcriptional activity of dihydrotestosterone (DHT)­ human androgen receptor (hAR) in vitro, decreased anogenital distance and/ or an increase in the retention of areolae/ nipples in male offspring following in utero exposure to linuron; (3) inhibition of steroidogenic enzymes, and (4) decreased responsiveness of Leydig cells to luteinizing hormone in both immature (22 days) and mature (11 months) male rats treated with linuron, mature rats were less responsive that immature animals; and, (5) F0 and F1 males had significantly increased levels of estradiol and luteinizing hormone. Linuron was not mutagenic in bacteria or in cultured mammalian cells. There was also no indication of a clastogenic effect up to toxic doses in vivo. Tumors were observed in oncogenicity studies in the rat and mouse, however, no sex and species differences were noted nor did they show consistent tumor profiles between sexes and species. The weight of evidence suggested that the carcinogenic potential of linuron in humans is weak, the HIARC decided that linuron should not be regulated as a carcinogen. The major metabolites identified in the rat metabolism study are hydroxy­ norlinuron, desmethoxy linuron (3­( 3,4­ dichlorophenyl)­ 1­ methylurea or DCPMU) and norlinuron (3,4­ dichlorophenylurea or DCPU). The metabolites DCPU and DCPMU were identified in the rat metabolism study, the plant and animal metabolism studies, and as water degradates in the aerobic soil metabolism study. These metabolites, in addition to desmethyl­ linuron, are among the metabolites of toxicological concern referenced in the tolerance expression and considered in this risk assessment. Linuron has low acute toxicity but exhibits developmental and neurotoxic concerns based on the neuroendocrine effects seen in the toxicological database. Toxicological endpoints were established for all exposure scenarios, populations and durations, except acute dietary exposure to the general population. No adverse effects attributed to a single exposure were identified for the general population. For the purposes of this tolerance reassessment eligibility decision (TRED) for linuron, only the acute and chronic dietary exposure scenarios will be assessed. There are no registered uses for linuron in the residential environment. Occupational exposure and risks were assessed in the previous re­ registration eligibility decision (RED) and will not be reassessed here. 6 An acute dietary endpoint was identified for females 13­ 50 years of age. This endpoint was derived from a developmental toxicity study in the rat and is based on increases in post­ implantation loss and litter/ fetal resorptions [No Observed Adverse Effect Level (NOAEL) = 12.1 mg/ kg/ day]. The chronic dietary endpoint was derived from an oral toxicity study in the dog and is based on abnormal hematology findings (increased met­ and sulfhemoglobin levels [NOAEL = 0.77 mg/ kg/ day]. A total uncertainty factor (UF) of 100 was applied (UF of 100 to account for both interspecies and intraspecies extrapolation). The FQPA Safety Factor Committee (SFC) concluded that the factor should be retained at 10x because there is a qualitative increase in susceptibility seen in the F1 males in the rat reproductive toxicity studies (a long­ term study). And, a developmental neurotoxicity study in rats is required for the chemical because linuron is an endocrine disruptor and there is evidence for testicular lesions and decreased fertility in the rat reproductive toxicity study. The Committee concluded that the safety factor could be reduced to 3x for acute dietary exposure to females 13­ 50, only, because there was no indication of susceptibility identified following in utero exposure, the toxicology database is complete for FQPA assessment; the dietary (food and water) exposure assessments will not underestimate the potential exposures for infants, children, and/ or women of childbearing age; and, there are no residential uses. Therefore, when assessing chronic dietary exposure and risk, the FQPA safety factor will be retained (10x) and when assessing acute dietary exposure and risk to females 13­ 50 the FQPA safety factor will be reduced (3x). Estimated acute dietary (food) risks for females 13­ 50 years of age associated with the use of linuron does not exceed the Agency's level of concern. The acute dietary risk for females 13­ 50 is approximately 10% of the acute Population Adjusted Dose (PAD) at the 99.9th percentile of exposure. The acute exposure analysis was a highly refined probabilistic analysis which utilized field trial data for parent linuron and its metabolites that are hydrolyzable to 3,4­ dichloroaniline (3,4­ DCA), percent of crop treated data, processing data and residue reduction studies. The chronic dietary risk estimate did not exceed the Agency's level of concern for any population subgroups examined including the most highly exposed sub­ group, children ages 1­ 6 years. The chronic dietary risk for children 1­ 6 years of age is approximately 35% of the chronic PAD and approximately 15% for the general U. S. population. The chronic exposure analysis is also highly refined and utilized field trial data (including the parent linuron and metabolites hydrolyzable to 3,4­ DCA), percent of crop treated data, and residue reduction data. Aggregate acute and chronic risk estimates include the contribution of risk from dietary (food+ water). There are no uses of linuron registered for the residential environment. Acute aggregate risk do not exceed the Agency's level of concern. However, the Agency cannot conclude with reasonable certainty that residues of linuron, plus its metabolites hydrolyzable to 3,4­ DCA in food and drinking water would likely result in an aggregate chronic risk to infants and children below the Agency's level of concern. The Agency based this determination on a comparison of estimated concentrations of linuron and its metabolites in surface water and groundwater to "drinking water levels of comparison" 7 N H Cl Cl O N O CH 3 CH 3 (DWLOCs) for linuron and its metabolites. However, since the drinking water exposure estimates are based on upper­ end input parameters such as the maximum application rate, the assessment indicates a need to refine the drinking water exposure estimates by attaining additional information about the persistence and mobility of linuron water degradates. The database for linuron is considered adequate for risk assessment, however, data deficiencies have been identified. Studies required by the Agency include a developmental neurotoxcity study, a 28­ day inhalation study in the rat, in addition to environmental fate data, including a leaching/ adsorption/ desorption study and a terrestrial field dissipation study. There are also a number of outstanding residue chemistry data requirements listed in Section 8.0. 2.0 Physical and Chemical Properties Linuron [3­( 3,4­ dichlorophenyl)­ 1­ methoxy­ 1­ methylurea] is a selective herbicide used for preemergent and post­ emergent control of many annual grasses and broadleaf weeds on asparagus, carrot, celery, field corn, sweet corn, cotton, parsley, parsnip, potato, sorghum, soybean, and winter wheat. Linuron end­ use products are formulated as flowable concentrate, emulsifiable concentrate, wettable powder, and granular types and are currently registered by Griffin Corporation, Drexel Chemical Company, and Micro­ Flo Company. Identity: 3­( 3,4­ dichlorophenyl)­ 1­ methoxy­ 1­ methylurea Class: Substituted Urea Empirical Formula: C9 H10 Cl2 N2 O2 Molecular Weight: 249.1 CAS Registry No.: 330­ 55­ 2 PC Code: 035506 Color: off­ white to light tan Physical state: solid Odor: odorless MP: 93­ 94 C Bulk density: 1.45 g/ cc Water solubility: 75 ppm @ 25 C vp: 1.5 x 10 ­5 mm Hg @ 24 C log Pow : 2.76 Stability: Stable up to MP; stable at concentrations of 5 & 5000 ppm in aqueous buffers [pH 5,7 &9] for 30 days @ 20 C. Linuron exhibits relatively low water solubility and low lipophilic potential and, thus is not likely to bioaccumulate. The vapor pressure for linuron is high; there is a likelihood of exposure via the inhalation route. Based on the physical and chemical properties of linuron, there is the potential for exposure to the chemical via all routes, oral, dermal and inhalation. However, this tolerance 8 reassessment eligibility decision document will assess the exposure and risks via the oral route (food and water pathways), only. There are no registered uses for linuron in the residential environment. Occupational exposures and risk will not be considered at this time as they were assessed at the time of the reregistration eligibility decision (RED). There are traces of manufacturing impurities which may be of toxicological concern reported in one of the linuron technical product confidential statement of formula. These manufacturing impurities are present in the production of linuron and other dichloroaniline derivative pesticides, including diuron and propanil. However, these impurities have been present in all toxicological test materials, and the Agency, therefore, does not believe that linuron risk has been underestimated at this time. 3.0 Hazard Characterization 3.1 Hazard Profile The acute toxicity of linuron is presented in Table 1. All studies were performed using linuron as the test substance. Table 1: Acute Toxicity of Linuron Guideline No. Study Type MRID No. Results Toxicity Category 870.1100 Acute Oral (Rat) 00027625 LD 50 = 2600 mg/ kg III 870.1200 Acute Dermal (Rabbit) 00027625 LD 50 > 2000 mg/ kg III 870.1300 Acute Inhalation (Rat) 00053769 LC 50 > 218 mg/ L IV 870.2400 Primary Eye Irritation 42849001 Slight conjunctival redness at 24 hrs; clear at 72 hrs III 870.2500 Primary Skin Irritation 42849002 Not an irritant IV 870.2600 Dermal Sensitization 00146868 Not a sensitizer N/ A The toxicity profile for linuron is shown in Table 2. 9 Table 2: Toxicity Profile Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 870.3100 90­ Day oral toxicityrat Requirement fulfilled by Chronic rat study870.4100a N/ A 870.3150 90­ Day oral toxicitydog Requirement fulfilled by Chronic dog study870.4100b N/ A 870.3200 21/ 28­ Day dermal toxicity­ rabbit No study available N/ A 870.3250 90­ Day dermal toxicity No study available N/ A 870.3465 90­ Day inhalation toxicity No study available N/ A 870.4100 [83­ 1( b)] 1­ Year Feeding Study ­ Dog 40952601 (1988) Acceptable/ Guideline 0, 10, 25, 125, 625 ppm %%: 0, 0.29, 0.79, 4.17, 18.6 mg/ kg/ day &&: 0, 0.30, 0.77, 3.49, 16.1 mg/ kg/ day NOAEL= 0.77 mg/ kg/ day LOAEL = 3.49 mg/ kg/ day, based on hematological effects in males and females (increased methemoglobin and sulfhemoglobin levels) Table 2: Toxicity Profile Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 10 870.4100 [83­ 1( b)] 2­ Year Feeding Study ­ Dog 00018374 (1963) Unacceptable/ Guideline 0, 25, 125, 625 ppm 0, 0.6, 3.1, 16 mg/ kg/ day (based on standard conversion factor of 0.025 .mg/ kg/ day per ppm) NOAEL= 3.1 mg/ kg/ day LOAEL = 16 mg/ kg/ day, based on mild hemolytic anemia, slightly deceased hemoglobin, hematocrit, and RBC counts 870.4200 [83­ 2 (b)] Oncogenicity Study Mouse 0124195 (1981) Acceptable/ Guideline 0, 50, 150, and 1500 ppm 0, 8, 23, and 261 mg/ kg/ day in males and 0, 12, 35, and 455 mg/ kg/ day in females NOAEL= 23 mg/ kg/ day LOAEL = 261 mg/ kg/ day, based on microscopic liver changes, methemoglobinemia, and deceased body weight gain throughout the study Histopathology: hepatocytomegaly, hepatocellular cytoplasmic alterations, vacuolation, and necrosis in liver, slightly increased incidence of hemosiderosis in spleens of both sexes; Significant increase in hepatocellular adenomas in females 870.4300 [83­ 5( a)] Combined Chronic Toxicity/ Carcinogenicity Study ­ Rat 0029680, 00029679 (1980) 00167411 (1986) Acceptable/ Guideline 0, 50, 125, 625 ppm 0,2.09, 5.11, 27.1 mg/ kg/ day in males and 0, 3.13, 7.75, 48.3 mg/ kg/ day in females NOAEL= 2.09 mg/ kg/ day LOAEL = 5.11 mg/ kg/ day, based on hematological effects, decreased body weight gains in both sexes, microscopic observations consistent with hemolysis (hemosiderin in Kupffer cells and increased hemosiderosis in bone marrow, spleen, and/ or mesenteric lymph nodes) Histopathology: Significant (p = 0.004) increase (27%, 5.7% control) in benign interstitial cell adenomas in testes incidences. Table 2: Toxicity Profile Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 11 870.3700 [83­ 3( a)] Developmental Toxicity Study ­ Rat 00018167 (1979) Acceptable/ Guideline 0, 50, 125, 625 ppm &&: 0, 5.0, 12, 50 mg/ kg/ day Maternal Systemic NOAEL: 12 mg/ kg/ day LOAEL = 50 mg/ kg/ day, based on decreased maternal body weight (9%) and food consumption (7­ 8%). Developmental NOAEL: 12 mg/ kg/ day LOAEL = 50 mg/ kg/ day, based on increased post­ implantation loss and litters with early resorptions. 870.3700 [83­ 3( b)] Developmental Toxicity ­ Rabbit 00153867 (1985), 40437201( 1985) Acceptable/ Guideline 0, 5, 25, 100 mg/ kg/ day Maternal Systemic NOAEL= 5 mg/ kg/ day LOAEL = 25 mg/ kg/ day, based on decreased maternal body weight gain. Developmental NOAEL = 25 mg/ kg/ day LOAEL = 100 mg/ kg/ day, based on alterations of the bones and skull (irregularly shaped fontanelle, hole in parietals, parietals contain intraparietals, and unossified). 870.3800 [83­ 4] 3­ Generation Reproduction ­ Rat 00146071 (1984) 00155168 (1985) Unacceptable/ Guideline 0, 25, 125, 625 ppm %%: 0, 2, 10­ 11, 48­ 50 mg/ kg/ day &&: 0, 2, 9, 44­ 50 mg/ kg/ day Systemic NOAEL= 2 mg/ kg/ day LOAEL = 9 mg/ kg/ day, based on decreased body weight gains in males and females and anemia in females. Reproductive NOAEL = 10 mg/ kg/ day LOAEL = 44 mg/ kg/ day based on reduced fertility, decreased pup survival, and lower pup body weights. Offspring NOAEL = 9 mg/ kg/ day LOAEL = 44 mg/ kg/ day, based on decreased pup survival, and lower pup body weights. Table 2: Toxicity Profile Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 12 870.3800 [83­ 4] 2­ Generation Reproduction ­ Rat 41463401 (1990) 41864701 (1991) Acceptable/ Guideline 0, 12.5, 100, 625 ppm %%: 0, 0.74, 5.8, 36 mg/ kg/ day &&: 0, 0.92, 7.3, 45 mg/ kg/ day, Systemic NOAEL= 0.74 mg/ kg/ day LOAEL = 5.8 mg/ kg/ day, based on decreased body weight gains in males and females in both generations Reproductive NOAEL = 36 mg/ kg/ day LOAEL = not established Offspring NOAEL= 0.74 mg/ kg/ day LOAEL = 5.8 mg/ kg/ day, based on decreased pup survival and lower pup body weights of F1a, b and F2a, b litters 870.7485 (85­ 1) Metabolism Study Rat 00146489 (1985), 40142401 (1985) 41960001 (1991 42006801 (1991) Linuron (single doses at 24 mg/ kg and 400 mg/ kg) was administered by gavage to male and female rats. The biological half­ lives ranged from 21 hr in the low dose males to 56 hr in the high dose females. Total recovery of radioactivity was 96% in males and 97% in females, the majority of the administered C­ linuron was eliminated in the urine (> 80%) and, to a lesser extent, in the feces (~ 15%). Tissue and organ residues were very low (< l%) at both dose levels, and there was no indication of accumulation or retention of linuron or its metabolites. The major metabolites identified in the urine were hydroxy­ norlinuron, desmethoxy linuron and norlinuron, and in feces, hydroxy­ norlinuron, and norlinuron. Neither hydroxy­ 3,4­ dichloroanaline nor 3,4­ dichloroanaline were present in any of the samples. Exposure to linuron appeared to induce mixed­ function oxidative enzymes. Table 2: Toxicity Profile Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 13 870.7600 (85­ 2) Dermal Penetration Rat 00163837 (1984) Acceptable/ Guideline 14 C (2.35 :Ci/ mg) 0.12, 1.00, or 7.4 mg/ 2 in2 2.82, 23.5, or 17.4 :Ci Dermal absorption factor = 16% over 8 to 10 hr (2%/ hr). 870.5100­ Bacterial reverse gene mutation assay MRID 00131738 Acceptable/ Guideline .5, 0.75, 1.0, 2.5, and 5.0 :g/ plate( S9­ mix) 1, 5, 10, 50, and 100 :g/ plate +S­ 9 mix. In a reverse gene mutation assay in bacteri, S. typhimurium strains TA98, TA100, TA1535, and TA1537 were exposed to Linuron (95­ 97%, lot number not given) in dimethylsulfoxide at concentrations of 0 There was no evidence of induced mutant colonies over background with or without S9 activation. Table 2: Toxicity Profile Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 14 870.5300 CHO/ HGPRT cell forward gene mutation assay MRID 00137152 Acceptable/ Guideline 0.05, 0.25, 0.35, 0.40, 0.45, and 0.50 mM (S9­ mix) 0.25, 0.50, 0.75, 0.90, and 1.0 mM (+ S9­ mix) In a mammalian cell gene mutation assay in vitro, triplicate (in the absence of activation) or duplicate (in the presence of activation) cultures of Chinese hamster ovary (CHO) CHO­ K1­ BH4 cells were exposed to Linuron (Lot No. 1N2­ 326­ 141, 94.5% a. i.) in F12 medium. The S9­ fraction was obtained from Aroclor 1254­ induced 8 to 9 week­ old male Charles River CD rats. Linuron was tested up to concentrations limited by cytotoxicity. Cytotoxicity was observed at 0.45 and 0.5 mM under nonactivated conditions and at 0.75 mM and above with 0.5 mg S9 protein/ mL and at 1.0mM and above with 1.0 mg S9 protein/ mL. (Percentage cell survival were not provided in the DER). There was no increase in mutant frequency in cells treated with linuron in either the presence or absence of metabolic activation. The positive (ethyl methane sulfonate (EMS) without S9­ mix and dimethylbenzanthracene with S9­ mix) and solvent (DMSO) controls responded appropriately. No evidence of an increased mutant frequency was observed in the presence or absence of metabolic activation. Table 2: Toxicity Profile Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 15 870.5385­ In vivo bone marrow chromosomal aberration assay MRID 00137153 Acceptable/ Guideline 0, 100, 300, or 1000 mg/ kg. In a mammalian cell cytogenetics chromosomal aberration assay in bone marrow cells of Sprague­ Dawley rats, 5 rats per sex per harvest time were administered Linuron (94.5%, lot number not given) by single gavage at doses. Bone marrow cells were harvested 6­, 12­, 24­, or 48­ hours after test compound administration and 48 hours after the positive control dose. The vehicle was corn oil (20 mL/ kg) and the positive control was a single 40 mg/ kg dose of cyclophosphamide. One high­ dose rat in the 24­ hour group was found dead and 8 of 10 high­ dose rats in the 48­ hour group died prior to sacrifice on day 2. Lowand mid­ dose animals exhibited slight depression, ataxia, and/ or prostration. Treated animals also had decreased body weights compared to controls. There was no significant increase in the frequency of aberrations in bone marrow cells of treated animals compared to controls at any sampling time. Values in treated animals ranged from 0.3­ 0.8% aberrant cells/ group; the positive control group had 19.6% aberrant cells, indicating that this control responded appropriately. There was no change in mitotic index of dosed groups compared to controls. There is no evidence that Linuron induced chromosomal aberrations in bone marrow cells of rats over background levels. Table 2: Toxicity Profile Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 16 870.5550 ­ Unscheduled DNA synthesis in mammalian cell culture MRID 00132583 Acceptable/ Guideline 0.00001, 0.0001, 0.001, 0.01, 0.1, 1.0, 10, and 50.0 mM (trial 1) 0.01, 0.1, 1.0, 10, and 50.0 mM (trial 2) In an unscheduled DNA synthesis assay, primary rat hepatocyte cultures were exposed to Linuron (94.5% a. i. in dimethylsulfoxide; Lot No. T80311­ 81) in Williams' Medium E (WME) for 18 hours. There is no evidence that Linuron induced chromosomal aberrations in bone marrow cells of rats over background levelS Special Study Leydig cell tumorigenesis in rats 41630101 (1990) Acceptable/ Nonguideline 0 or 200 mg/ kg/ day for 14 days to 32 to 33 and 93 day old rats No treatment­ related clinical signs of toxicity were observed. Body weight and body weight change were significantly less than controls and decreased accessory sex organ weights for growing and adult rats. 0, 0.74, 5.8, 36 mg/ kg/ day in males and 0, 0.92, 7.3, 45 mg/ kg/ day in females F0 and F1 animals from 2­ generation reproduction study (41463401), Selected animals from the 2­ generation reproduction study were used to evaluate changes in serum hormone levels, accessory sex organ weights. Increased serum luteinizing hormone and estradiol levels were observed in F0 and F1 males. High­ dose F0 males had decreased absolute epididymides, dorsal lateral prostate, and levator ani muscle weights and increased relative testes, epididymides, and ventral prostate weights. Organ weights were unaffected in the two lower dose groups. These data support the hypothesis that rats exposed to linuron could develop interstitial hyperplasia and subsequent adenomas (Leydig cell tumors) via a mechanism of sustained hypersecretion of luteinizing hormone induced by the antiandrogenic potential of linuron. Table 2: Toxicity Profile Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 17 Special Study ­ Cross Mating ­ Rats 00159846 (1985) Acceptable/ Nonguideline 0, 625 ppm %%: 0, 48 mg/ kg/ day &&: 0, 44 mg/ kg/ day The cross­ mating results suggest that linuron may cause paternally­ mediated effects based on decreased fertility and fecundity as well as maternally­ mediated effects based on decreased pup viability and litter survival. Special Study ­ Aged male rats 45506501 (1986) Acceptable/ Nonguideline 0, 625 ppm 0, 22 mg/ kg/ day Linuron induced hyperplasia and adenomas of the testes in aged rats. In addition, life­ time feeding was not necessary to induce oncogenic responses in this tissue. Exposure duration was 6 to 12 months. Special Study Biochemical and Histopathological effects 164093 (1986) Acceptable/ Nonguideline 0, 12.5, 100, 625 ppm %%: 0, 0.75, 4.1, 22 mg/ kg/ day &&: 0, 1.1, 6.1, 37 mg/ kg/ day The biochemical and histopathological data presented in this report suggest that linuron may affect testosterone metabolism in horse testicular microsomes for a range of concentrations which overlap the dose levels given rats chronically. However, the net effect of these enzyme changes and the relevance to the rat in vivo are uncertain. Evidence in young and old rats exposed repeatedly (3­ 7x) or for 11 or 19 months suggests that Leydig cell incubates are differentially altered in their sensitivity to LH. Microscopic lesions in the testes and cervix have been confirmed in other studies. The toxicological database for linuron is considered adequate for hazard characterization. The toxicity profile of linuron can be characterized for all effects including potential developmental, reproductive, and neuroendocrine effects. Linuron elicits effects primarily upon the hematopoetic system and also displays evidence of endocrine disruption. There was evidence of qualitative susceptibility in both the 2­ and 3­ generation rat reproduction studies in the toxicological database. Based upon a dermal penetration study in the rat, a dermal absorption factor of 16% for 8­ 10 hours of 18 exposure was determined. In addition, linuron is not regulated as a carcinogen, and, there is an adequate metabolism study in the rat. However, there are toxicological data gaps for linuron. The HIARC requires that both a 28­ day inhalation study and a developmental neurotoxicity (DNT) study be performed to provide better hazard characterization. The requirement of the DNT is based upon the finding that linuron is an endocrine disruptor. Linuron has low acute toxicity, with toxicity categories of III for oral (LD50 2600 mg/ kg), dermal (LD50 > 2000 mg/ kg) and toxicity category IV for inhalation ( LC50 > 218 mg/ L/ hr). Primary eye and skin irritation studies were category III and IV, respectively; no dermal sensitization was observed in rabbits. The major finding in chronic toxicity studies in the dog, mouse and rat was altered hematological parameters. Dogs fed linuron at concentration of 16.1 mg/ kg/ day, resulted in hemolytic anemia and secondary erythropogenic activity evidenced by slightly reduced hemoglobin, hematocrit, and erythrocyte counts accompanied by hemosiderin deposition in liver Kupffer cells and erythroid hyperplasia of bone marrow. Methemoglobinemia was seen at the LOAEL dose in the chronic dog study. Systemic toxicity observed in mice included increased methemoglobin formation and vacuolation and hemosiderosis of the spleen. In another chronic study, ChR­ CD rats fed linuron at 5.11 mg/ kg/ day in males and 7.75 mg/ kg/ day in females, displayed microscopic observations consistent with hemolysis (hemosiderin in Kupffer cells and increased hemosiderosis in bone marrow, spleen, and/ or mesenteric lymph nodes). Other findings observed in the chronic toxicity study in the rat include, a significant decrease in body weight gain after one week of treatment which was observed at 600 ppm in males (59% of control) and females (53% of control). These decreases persisted throughout the entire study, with females showing consistently lower body weight gains (68 to 76%) than males (82 to 93%). The decreases in body weight gains correlated to some degree with decreased food consumption. Rats also showed increased incidences of microscopic changes in the epididymides (perivasculitis/ vasculitis) and renal pelvis (transitional cell hyperplasia and mineralization/ calculi) of males and kidneys (calculi in renal tubules) of females. In a developmental toxicity study using rats, the highest dose level caused decreased body weight gain and food consumption in the dams, as well as the developmental effect of increased postimplantation loss and fetal resorptions. In a study using rabbits, linuron caused decreases in maternal body weight, food consumption and liver weight, as well as abortions, fewer fetuses per litter, decreased fetal body weight, and an increased incidence of fetuses with skeletal skull variations. However, the HIARC determined that neither quantitative nor qualitative susceptibility was indicated by these test results since increases in resorptions were marginal and there was no change in the number of live fetuses to corroborate the increases in post­ implantation losses. There was no quantitative evidence of susceptibility either in the 2­ generation or the 3­ generation 19 reproduction studies. In the 2­ generation study, reduced body weight gains of pups were seen at the same dose that caused decreases in parental body weights. In the 3­ generation study, offspring effects (deceased pup survival and pup body weight) were seen a dose ( 44 mg/ kg/ day) higher than the dose that caused decreases in body weight gain in the parental animals (9 mg/ kg/ day). However, when the reproductive effects were examined, testicular atrophy was seen at the same dose (625 ppm, 45 mg/ kg/ day) in both studies. In both studies, while the F0 males were not affected, testicular lesions and reduced fertility were seen in the F1 males. This effect in the F1 males is an indication of qualitative evidence of susceptibility. In addition, there is ample evidence from special studies submitted by the registrant as well as open literature studies which indicate that linuron is an endocrine disruptor. These findings include, in part: (1) competitive androgen receptor antagonist; but not an estrogen receptor antagonist; (2) competitive inhibition of the transcriptional activity of dihydrotestosterone (DHT)­ human androgen receptor (hAR) in vitro, (3) decreased anogenital distance and/ or an increase in the retention of areolae/ nipples in male offspring following in utero exposure to linuron; (4) inhibition of steroidogenic enzymes, and (5) decreased responsiveness of Leydig cells to luteinizing hormone in both immature (22 days) and mature (11 months) male rats treated with linuron (mature rats were less responsive than immature ones); (6) F0 and F1 males had significantly increased levels of estradiol and luteinizing hormone. Oncogenicity studies in the rat and mouse did not show consistent tumor profiles between sexes and species. In the combined chronic toxicity/ oncogenicity study in rats, common neoplasms, included pituitary adenomas of the pars anterior in both male and female rats and mammary fibroadenomas in female rats. Testicular adenomas were observed in 6%, 28% and 54%, respectively for control, 125 and 625 ppm dose groups. Decreased incidences of both these tumor types were noted in the highdose female group. In the mouse oncogenicity study, treatment of up to 104 weeks with 1500 ppm resulted in a significant increase in the incidence of hepatocellular adenomas (control, 6%; 1500 ppm, 25%, p < 0.05) in females. Linuron was not mutagenic in bacteria or in cultured mammalian cells. There was also no indication of a clastogenic effect up to toxic doses in vivo. Based on the results of these studies, linuron was classified as an unquantifiable Group C carcinogen (a possible human carcinogen for which there is limited animal evidence) requiring no quantification of human cancer risk. A rat metabolism study demonstrates that the biological half­ lives of linuron ranged from 21 hr in the low dose males to 56 hr in the high dose females. Total recovery of radioactivity was 96% in males and 97% in females, the majority of the administered 14 C­ linuron was eliminated in the urine (> 80%) and, to a lesser extent, in the feces (~ 15%). Tissue and organ residues were very low (< l%) at both dose levels, and there was no indication of accumulation or retention of linuron or its metabolites. The major metabolites identified in the urine were hydroxy­ norlinuron, desmethoxy linuron (3­( 3,4­ dichlorophenyl)­ 1­ methylurea or DCPMU) and norlinuron (3,4­ dichlorophenylurea or DCPU), and in feces, hydroxy­ norlinuron, and norlinuron. The major metabolites DCPU and DCPMU were identified in the rat metabolism study, in both plant and animal metabolism studies, and as water metabolites in the aerobic soil metabolism study. These metabolites, in addition to desmethyl­ linuron, are the metabolites of toxicological concern referenced in the tolerance expression and considered in this risk assessment. 20 Neither hydroxy­ 3,4­ dichloroanaline, 3,4­ dichloroanaline nor 3,3', 4,4'­ tetrachloroazobenzene (TCAB) were present in any of the samples in the rat metabolism study. Exposure to linuron appeared to induce mixed­ function oxidative enzymes in mammals. 3.2 FQPA Considerations There is no qualitative/ quantitative evidence of increased susceptibility in the rabbit developmental study; developmental effects were seen at a dose higher than that causing maternal toxicity. In the rat developmental toxicity study, increases in post­ implantation losses and increases in fetal resorptions/ litter were seen at a dose that caused decreases in maternal body weight and food consumption. The HIARC determined that the developmental effects are not a concern for qualitative evidence of susceptibility, since increases in resorptions were marginal and there was no change in the number of live fetuses to corroborate the increases in post­ implantation losses. There was no quantitative evidence of susceptibility identified in either the 2­ generation or the 3­ generation reproduction studies. In the 2­ generation study, reduced body weight gains of pups were seen at the same dose that caused decreases in parental body weights. In the 3­ generation study, offspring effects (deceased pup survival and pup body weight) were seen a dose higher than the dose that caused decreases in body weight gain in the parental animals. In both the 2­ generation and the 3­ generation rat reproductive toxicity studies, testicular atrophy was seen at the same dose that caused parental/ systemic toxicity. The HIARC determined that these findings were of a concern and provide qualitative evidence of increased susceptibility because in both studies they were seen in the F1 males but not in F0 males. This indicates an adverse effect on the male reproductive system of the F1 generation. The HIARC concluded that a development neurotoxicity study in the rat is required by the available evidence. This conclusion is based on the findings that linuron is an endocrine disruptor, as evidenced by the observation of increased testicular lesions and decreased fertility in the reproduction studies. The FQPA SFC concluded that a safety factor should be retained at 10x because: 1. A qualitative increase in susceptibility was seen in the F1 males in the rat reproductive toxicity study (a long­ term study); and 2. A developmental neurotoxicity study in rats is required for the chemical because linuron is an endocrine disruptor and there is evidence for testicular lesions and decreased fertility in the rat reproductive toxicity study. However, the Committee concluded that the safety factor could be reduced to 3x for acute dietary exposure to females 13­ 50 years of age because: 1. There was no susceptibility identified in following in utero exposure; 21 2. The toxicology database is complete for FQPA assessment; 3. The dietary (food and water) exposure assessments will not underestimate the potential exposures for infants, children, and/ or women of childbearing age; and, 4. There are no residential uses. When assessing acute dietary exposure of females 13­ 50 years of age, the safety factor should be reduced to 3x since the developmental neurotoxicity study in rats is required and may further define the potential neuro­ endocrine effects observed in rats that were exposed in pre­ and post­ natal time periods. However, when assessing chronic dietary exposure to all other population sub­ groups, the safety factor should be retained at 10x since there is concern for the qualitative increase in susceptibility observed in the rat reproductive toxicity study (a long­ term study), and, since the developmental neurotoxicity study in rats is required. The developmental neurotoxicity study may further define the potential neuro­ endocrine effects observed in rats due to pre­ and post­ natal exposure. 3.3 Dose­ Response Assessment Toxicological endpoints were established for all exposure scenarios. Acute dietary exposure to the general population is not assessed since there was no appropriate endpoint attributable to a single­ dose available in the database. Three toxicological studies determined toxicological endpoint doses: a prenatal developmental toxicity study in the rat, a chronic oral study in the dog, and, a 2­ generation reproduction study in the rat. For this tolerance reassessment eligibility decision for linuron, only the acute and chronic dietary exposure scenarios will be assessed because there are no registered uses for linuron in the residential environment. Occupational exposures and risks will not be considered at this time as they were assessed at the time of the reregistration eligibility decision (RED). A discussion of the dose­ response relationships for acute and chronic dietary endpoints follows presentation of Table 3. (Linuron ­ Report of the Hazard Identification Assessment Review Committee, HED Doc. No. 0050286, Robert Fricke November 20, 2001.) Table 3: Toxicological Endpoints for Risk Assessment Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF and Endpoint for Risk Assessment Study and Toxicological Effects Acute Dietary females 13­ 50 years of age NOAEL = 12 UF = 100 Acute RfD = 0.12 mg/ kg/ day FQPA SF = 3 aPAD = acute RfD FQPA SF = 0.04 mg/ kg/ day Prenatal Oral Developmental / Rat LOAEL = 50 mg/ kg/ day based on increased post­ implantation loss and fetal/ litter resorptions. Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF and Endpoint for Risk Assessment Study and Toxicological Effects 22 Acute Dietary general population including infants and children N/ A N/ A No appropriate effects attributed to a single exposure were identified. Chronic Dietary all populations NOAEL= 0.77 mg/ kg/ day UF = 100 Chronic RfD = 0.007 mg/ kg/ day FQPA SF = 10 cPAD = chr RfD FQPA SF = 0.00077 mg/ kg/ day Chronic Feeding Study ­ Dog LOAEL = 4.17 mg/ kg/ day in males and 3.5 mg/ kg/ day in females based on increased met­ and sulfhemoglobin levels. Short­ Term Oral (1­ 7 days) (Residential) NOAEL= 5.8 mg/ kg/ day LOC for MOE = 1000 (Residential, includes the FQPA SF) 2­ Generation Reproduction Study/ Rat LOAEL = 36 mg/ kg/ day based on statistically and biologically significant decrease in premating body weights in F0 and F1 animals IntermediateTerm Oral (1 week ­ several months) (Residential) NOAEL= 0.77 mg/ kg/ day LOC for MOE = 1000 (Residential, includes the FQPA SF) Chronic Feeding Study ­ Dog LOAEL = 4.17 mg/ kg/ day in males and 3.5 mg/ kg/ day in females based on increased met­ and sulfhemoglobin levels. Short­ Term Dermal (1­ 30 days) (Occupational/ Residential) Oral NOAEL= 5.8 mg/ kg/ day dermal absorption rate = 16% LOC for MOE = 100 (Occupational) LOC for MOE = 1000 (Residential, includes the FQPA SF) 2­ Generation Reproduction Study/ Rat LOAEL = 36 mg/ kg/ day based on statistically and biologically significant decrease in premating body weights in F0 and F1 animals Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF and Endpoint for Risk Assessment Study and Toxicological Effects 23 IntermediateTerm Dermal (1 ­ 6 months) (Occupational/ Residential) Oral NOAEL= 0.77 mg/ kg/ day dermal absorption rate = 16% LOC for MOE = 100 (Occupational) LOC for MOE = 1000 (Residential, includes the FQPA SF) Chronic Feeding Study ­ Dog LOAEL = 4.17 mg/ kg/ day in males and 3.5 mg/ kg/ day in females based on increased met­ and sulfhemoglobin levels after 3 and 6 months of treatment Long­ Term Dermal (Longer than 6 months) (Occupational/ Residential) Oral NOAEL= 0.77 mg/ kg/ day dermal absorption rate = 16% LOC for MOE = 100 (Occupational) LOC for MOE = 1000 (Residential, includes the FQPA SF) Chronic Feeding Study ­ Dog LOAEL = 4.17 mg/ kg/ day in males and 3.5 mg/ kg/ day in females based on increased met­ and sulfhemoglobin levels. Short­ Term Inhalation (1­ 30 days) (Occupational/ Residential) Oral NOAEL= 5.8 mg/ kg/ day (inhalation absorption rate = 100% LOC for MOE = 1000 (Residential, includes the FQPA SF) 2­ Generation Reproduction Study/ Rat LOAEL = 36 mg/ kg/ day based on statistically and biologically significant decrease in premating body weights in F0 and F1 animals IntermediateTerm Inhalation (1 to 6 months) (Occupational/ Residential) Oral NOAEL= 0.77 mg/ kg/ day (inhalation absorption rate = 100% LOC for MOE =1000 (Residential, includes the FQPA SF) Chronic Feeding Study ­ Dog LOAEL = 4.17 mg/ kg/ day in males and 3.5 mg/ kg/ day in females based on increased met­ and sulfhemoglobin levels. Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF and Endpoint for Risk Assessment Study and Toxicological Effects 24 Long­ Term Inhalation (Longer than 6 months) (Occupational/ Residential) Oral NOAEL= 0.77 mg/ kg/ day inhalation absorption rate = 100% LOC for MOE = 100 (Occupational) LOC for MOE = 1000 (Residential, includes the FQPA SF) Chronic Feeding Study ­ Dog LOAEL = 4.17 mg/ kg/ day in males and 3.5 mg/ kg/ day in females based on increased met­ and sulfhemoglobin levels. Cancer (oral, dermal, inhalation) Group C carcinogen Does not require quantification of human cancer risk Based on a dose­ related increase in interstitial cell hyperplasia and adenomas in a two­ year rat feeding study and hepatocellular tumors that appeared in low­ dose male and highdose female mice in a two­ year feeding study 1 UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, LOC = level of concern, MOE = margin of exposure 3.3.1 Acute Reference Dose (RfD) ­ Females 13­ 50 The study selected to define the dose­ response relationship for risk assessment is a prenatal oral developmental study in the rat (MRID 00018167). In this study, 27 presumed pregnant Crl: CD rats per group were administered 0, 50, 125, or 625 ppm of linuron (97% a. i.; Lot No. INZ­ 326­ 118) in the diet on gestation days (GD) 6­ 15, inclusive. All animals survived to scheduled termination without the appearance of any treatment­ related clinical signs of toxicity. Gross necropsy was unremarkable. No treatment­ related clinical signs of toxicity were observed. The maternal toxicity LOAEL is 625 ppm (50 mg/ kg/ day) based on reduced body weight gains and food consumption. The maternal toxicity NOAEL is 125 ppm (12 mg/ kg/ day). No dose­ or treatment­ related effects were observed on fetal sex ratios, numbers of corpora lutea/ dam, implantations/ dam, live or dead fetuses/ dam, fetal body weights, or crown­ rump length in the low and mid­ dose groups. In the high­ dose group, bipartite thoracic vertebral centra was observed in 7 fetuses from 7 litters and unopposed sternebrae were observed in 3 fetuses from 3 litters. These anomalies were not found in the control group and were considered indicative of developmental delays. Therefore, the developmental toxicity LOAEL is 50 mg/ kg/ day based on increases in post­ implantation 25 loss and in litter/ fetal resorptions. The developmental toxicity NOAEL is 12 mg/ kg/ day. Therefore, the dose and endpoint for establishing the acute reference dose (RfD) is a NOAEL = 12 mg/ kg/ day, based on increases in post­ implantation loss and litter/ fetal resorptions at the LOAEL of 625 ppm (50 mg/ kg/ day). An uncertainty factor of 100x (10x intraspecies variability, 10x interspecies extrapolation) is recommended. The developmental effects are presumed to occur following a single exposure of females of child­ bearing age and, therefore, are appropriate for this risk assessment. Acute RfD = 12 mg/ kg/ day = 0.12 mg/ kg/ day 100( UF) 3.3.2 Chronic Reference Dose (RfD) For the chronic reference dose, the study selected to define the dose­ response relationship for risk assessment is a chronic toxicity (1­ Year) study in the dog (MRID 40952601). In this study, linuron (96.2% a. i., Batch No. 6,569) was administered to groups of 4 male and 4 female dogs in the diet at concentrations of 0, 10, 25, 125, or 625 ppm. No treatment­ related clinical signs of toxicity or mortalities were observed at any dose level. However, red blood cell counts, hemoglobin, and hematocrit were slightly decreased throughout the study in high­ dose males and females as compared with those of the controls. White blood cell and platelet counts were significantly (p # 0.05) increased in high­ dose females at 3, 6, and 9 months and platelet counts were increased (p # 0.05) in high­ dose males at 3 months. Met­ and sulf­ hemoglobin levels were significantly (p # 0.05) increased in the 625 ppm males and females at all time points as compared with those of the controls. In addition, for the 125 ppm groups methemoglobin levels were increased (p # 0.05) in males and females at 3 and 6 months while sulfhemoglobin levels were (p # 0.05) increased at 9 months in males and at 3, 9, and 12 months in females. Increased hematopoiesis was observed in the bone marrow in 3/ 4 high­ dose males and 4/ 4 high­ dose females, compared with none of the control males and only 1/ 4 control females. The LOAEL for linuron in male and female beagle dogs was established at 4.2 mg/ kg/ day in males and 3.5 mg/ kg/ day in females based on abnormal hematology findings (increased met­ and sulfhemoglobin levels). The NOAEL was established at 25 ppm (0.79 mg/ kg/ day, males and 0.77 mg/ kg/ day, females). An uncertainty factor of 100x (10x intraspecies variability, 10x interspecies extrapolation) was recommended. Chronic RfD = 0.77 mg/ kg/ day = 0.0077 mg/ kg/ day 100 (UF) 3.4 Endocrine Disruption From special studies (non­ guideline) and open literature publications, linuron was shown to be an 26 endocrine disruptor. Key findings include (See HIARC Report, HED Doc. No. 0050286, Robert Fricke November 20, 2001 for more details): (1) Linuron and some of its metabolites are androgen receptor antagonists; (2) Rats treated with linuron had reduced anogenital distance, retention of nipples, and a low incidence of hypospadias; (3) The responsiveness of Leydig cells to luteinizing hormone was decreased in both immature (22 days) and mature (11 months) male rats treated with linuron. Mature rats were less responsive that immature ones; (4) F0 and F1 males had significantly increased levels of estradiol and luteinizing hormone; (5) Linuron inhibits activities of steroidogenic enzymes; and, (6) A dose­ dependent increase in areola/ nipple retention in male rats. The Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) is the Agency's body that is asked to develop a screening program to determine whether certain substances "may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." However, in the case of linuron, the toxicological database includes compelling evidence that the chemical is an endocrine disruptor. The Agency believes that this assessment is protective of these effects. The endpoints selected for regulation of linuron are below the doses at which endocrine effects (areola/ nipple retention, hypoplastic testes and epididymides, and partial agenesis of the epididymides) were seen (HIARC Report, HED Doc. No. 0050286, Robert Fricke November 20, 2001). When additional testing protocol are developed, linuron may be subjected to further study to better characterize effects related to endocrine disruption. 3.5 Potential Tetrachloroazobenzene Contamination This section has been derived from the Diuron Risk Assessment (DP Barcode D272130). Diuron, propanil and linuron have all been reported to contain trace amounts of a manufacturing impurity, 3,3', 4,4'­ tetrachloroazobenzene, a. k. a. TCAB, which has been shown to be a cytochrome P450 enzyme inducer. A summary of short­ term bioassays compiled by the National Toxicology Program states that, "3,3', 4,4'­ tetrachloroazobenzene caused typical dioxin­ like effects, such as thymic atrophy, an increase in liver weights, induction of hepatic cytochrome P4501A, and decreased mean body weight gains. Furthermore, in the 13­ week studies, a sharp decrease in circulating thyroxine 27 concentrations was observed even at the lowest dose (0.1 mg/ kg) tested in rats. Other effects included a decrease in epididymal spermatozoal concentration in mice, major effects on the hematopoietic system, and increased incidences of hyperplasia of the forestomach in 3 and 30 mg/ kg males and 30 mg/ kg females. A NOAEL was not reached in rats. The NOAEL in mice was 0.1 mg/ kg. Comparison of various dioxin­ like effects in these studies with those reported in the literature indicate that 3,3', 4,4'­ tetrachloroazobenzene is six to two orders of magnitude less potent than 2,3,7,8­ tetrachlorodibenzo­ p­ dioxin." Chronic toxicity/ carcinogenicity studies are not available for TCAB. The specific endpoint( s) and related dose levels that may be observed in chronic toxicity studies, or the specific carcinogenic potential of this compound is not known. However, since it is assumed that TCAB may have been present in all linuron toxicological test materials, including the test material for the chronic toxicity/ carcinogenicity studies, the Agency believes that the risks from exposure to linuron (including carcinogenic potential) have not been underestimated. 4.0 Exposure Assessment and Characterization 4.1 Summary of Registered Use Patterns Linuron [3­( 3,4­ dichlorophenyl)­ 1­ methoxy­ 1­ methylurea] is a substituted urea compound and controls a variety of weed species including annual morning glory, rye grass, and barnyard grass. Linuron is a systemic, selective herbicide that works as a photosynthesis inhibitor (Hill reaction). Linuron may be applied pre­ plant, pre­ emergence, post­ emergence or post­ transplant and is registered for use on asparagus, carrots, celery, field and sweet corn, cotton, parsley, potatoes, sorghum, soybeans, and wheat. Linuron can be applied using ground equipment including band sprayer, boom sprayer, sprinkler irrigation, and tractor mounted sprayer as well as using aerial application methods. Linuron is formulated as an emulsifiable concentrate, flowable concentrate, water dispersible granules, and a wettable powder. The range of percentage of active ingredient in the product formulations is 40­ 50%. The application rates range from 0.5­ 4.0 lbs ai/ acre/ year and 1 or 2 applications are allowed per year. Linuron is mainly an early season use, but a few crops have relatively short PHIs, notably asparagus (1 day) and carrot (14 days). Pre­ harvest intervals are currently not often specified on the label and are necessary. This is one of the recommendations made in this tolerance reassessment. A profile of linuron usage has been developed by the OPP Biological and Economic Analysis Division (F. Hernandez, August 18, 2000). The use profile is based on data from EPA, USDA, and the National Center for Food and Agricultural Policy. Based on data from 1988 through 1997, an annual estimate of linuron total domestic usage averaged 1.2 million pounds of active ingredient for over two million acres treated. The largest market interms of total pounds of active ingredient is allocated to soybean (75%), carrots (9%), and potatoes (7%). Most of the usage is in the Midwestern states of 28 Illinois, Indiana, Ohio, and Michigan and also Maryland and Washington states. Crops with the highest percent of crop treated include carrots (100%), asparagus (33%) and celery (22%). This information has been used in the food exposure analysis. There are no registered uses for this chemical at residential sites. The populations of concern for this assessment are those who may be exposed through consuming crops treated with linuron or consuming water contaminated with linuron. 4.2 Dietary (Food) Exposure/ Risk Pathway 4.2.1 Residue Profile The qualitative nature of the residue in plants and animals is adequately understood. Plant metabolism studies show the major plant metabolites to be 3,4­ dichlorophenylurea or DCPU (a. k. a. norlinuron) and desmethoxy­ linuron (3­( 3,4­ dichlorophenyl)­ 1­ methylurea, DCPMU). There was a significant amount of unidentified polar components in both plant metabolism studies, however, it was concluded that the components in plants are hydrolyzable to 3,4­ dichloroaniline (3,4­ DCA). In animals, linuron is metabolized to DCPU and hydroxy­ norlinuron through desmethoxy­ linuron and demethyl­ linuron intermediates. Small amounts of 3,4­ dichloroaniline were detected in both the corn and poultry studies. The registrant analyzed poultry tissues, excreta, and eggs for TCAB and TCAOB residues and none were detected. The chemical structures of the metabolites of concern are listed in Figure 1. Tolerances are currently established for the use of linuron on asparagus, carrots, celery, field and sweet corn, cotton, parsley, potatoes, sorghum, soybeans, and winter wheat. The tolerance for asparagus is 7.0 ppm and the tolerance for field corn is 6.0 ppm, all other tolerances range from 0.05­ 2.0 ppm. They are listed at 40 CFR 180.184. During the Phase II Response to Error­ Only Comment time period, two new uses supported by the Inter­ regional Research Project number 4 (IR­ 4) were added to the list of crops on which linuron may be used, rhubarb (0.5 ppm) and celeriac (1.0 ppm). These additional uses are incorporated into this risk assessment. Tolerances for residues of linuron are currently expressed in terms of linuron per se. However, the HED Metabolism Assessment and Review Committee (MARC) determined that the tolerance expression under 40 CFR §180.184( a) and (c) should be revised as follows: "Tolerances are established for the combined residues of the herbicide linuron (3­( 3,4­ dichlorophenyl)­ 1­ methoxy­ 1­ methylurea) and its metabolites convertible to 3,4­ dichloroaniline, calculated as linuron." It should be noted that the analytical method for quantifying residues of concern from application of linuron converts all residues to 3,4­ DCA as a technical convenience. (Linuron Plant and Animal Metabolism: Results of the HED Metabolism Committee Meetings held October 21 and October 29, 1993. Dennis McNeilly. November 17, 1993.) The MARC concluded that residues of 3,4­ DCA are not of regulatory concern in connection with the 29 N H Cl Cl O N O CH 3 CH 3 N H N H O Cl Cl CH 3 N H NH 2 O Cl Cl N H Cl Cl O N H O CH 3 N H Cl Cl O NH 2 OH NH 2 Cl Cl registered use of linuron. Tolerances for linuron residues of concern in milk are being recommended in this action. There are established tolerances for linuron residues of concern in the meat, fat, and meat byproducts of cattle, goat, swine, horse, and sheep. Tolerances are being recommended for the liver and kidney of certain animal commodities and a reduction in tolerance is recommended for certain animal tissues. Metabolism studies with corn, soybeans, and potatoes indicate that linuron is absorbed from the soil and translocated (i. e., systemic). Poultry and ruminant feeding studies were also performed. These studies show that the metabolic pathways for plants and animals are similar. Figure 1. Chemical names and structures of linuron and its metabolites identified in plant and animal commodities. Linuron: 3­( 3,4­ dichlorophenyl)­ 1­ methoxy­ 1­ methylurea DCPMU; IN­ 15654; Desmethoxy linuron: 3­( 3,4­ dichlorophenyl)­ 1­ methylurea DCPU; Norlinuron; IN­ R915: 3,4­ dichlorophenylurea Desmethyl linuron: 3­( 3,4­ dichlorophenyl)­ 1­ methoxyurea Hydroxy­ norlinuron: (4,5­ dichloro 2­ hydroxyphenyl) urea 3,4­ DCA: 3,4­ dichloroaniline Metabolism studies also illustrate the distribution of residues of linuron within plant and animals. Radiolabeled 14 C­ linuron equivalents were found in corn forage and potato and soybean foliage. Detectable residues were also found in the potato plant itself, however. In animals, the highest levels of 14 C­ linuron equivalents were found in the liver of both goat and poultry. No intact linuron (< 0.001 ppm) was detected in the milk, tissues, or urine of the test animals. About 95% of the radioactivity in milk was identified as polar metabolites based on polar solvents used in the analytical procedure. No attempts were made to identify these polar metabolites. The residues listed in the tolerance expression are the same that will be included in the dietary risk assessment, linuron and metabolites convertible to 3,4­ DCA. On November 17, 1993, the HED Metabolism Assessment and Review Committee (MARC) met to discuss the plant and animal metabolism of linuron. Plant metabolism studies in corn, potato, and soybean as well as animal metabolism studies in poultry and for ruminant consumption, were considered by the committee. The terminal residues of concern in plants and animals are linuron (parent) and 30 metabolites convertible to 3,4­ DCA including desmethoxy­ linuron, norlinuron, desmethyl linuron, and hydroxy­ norlinuron. The committee also decided that 3,4­ DCA was not of regulatory concern in connection with the registered use of linuron due to the very low levels at which the chemical is detected in plants and animals (< 0.01ppm). The MARC concluded that with the possible exception of 3,4­ DCA itself, metabolites convertible to 3,4­ DCA are not likely to be more toxic than the parent compound. Linuron can therefore, be regulated by using the enforcement analytical method in which unidentified polar components in plants and bound residues in animal tissues are hydrolyzed to 3,4­ DCA. The total residue convertible to 3,4­ DCA will be compared to the reference dose for parent linuron for purposes of dietary risk assessment. The MARC did not review linuron as part of the TRED process because no new metabolism information was provided since the time of the RED (EPA 738­ R­ 95­ 003, March 1995). Samples for the plant and animal metabolism studies were analyzed using the extraction procedures of the enforcement methods (colorimetric method and modifications thereof and the GC/ ECD method). These methods demonstrate that the identified metabolites plus a large portion of the unidentified polar metabolites were converted to 3,4­ DCA and would therefore be determined using the enforcement method. (Linuron TRED Residue Chemistry Consideration, D272368, John Punzi, November 26, 2001) HED has confidence in the magnitude of the residue data used to determine reassessed tolerances for linuron in/ on plant and animal commodities. Adequate and representative field trial studies are available to assess the degree of chemical in food commodities. Field trial studies showed detectable residues of linuron on plants, and, ruminant feeding studies and animal metabolism studies indicate transfer of residues to meat and milk. The tolerance for asparagus is 7.0 ppm and the tolerance for field corn is 6.0 ppm, all other tolerances range from 0.05­ 2.0 ppm. However, there are some aspects of the residue chemistry database that are incomplete for linuron. There are a number of label amendments required. The amendments relate to the use of linuron in tank mixes, impractical grazing/ feeding restrictions which should be removed from the label, and the specification of PHIs for several crops and use directions. Use directions on product labels for asparagus and soybean need to be clarified. The re­ registeration requirements for residue analytical methods are not fulfilled as the registrants must proposed a new enforcement method. In addition, storage stability requirements are not fulfilled for some crops. Information about cotton, sweet corn and parsnips must be submitted. The re­ registration requirements for magnitude of the residue in plants are not fulfilled for a number of crops. The unsatisfied data requirements for crops are generally either storage stability information or additional geographic representation. The re­ registration requirements for the magnitude of the residue in processed food/ feed are fulfilled for field corn, cotton, soybeans, and wheat. Previous actions by the Agency concluded that additional data were required to upgrade an existing potato processing study. These data are not available, but are considered confirmatory. There are sufficient data available to reassess tolerances and estimate dietary exposure for potato processed products. Generally, residues of linuron and metabolites do not 31 appear to concentrate in processed commodities. There are, however, two exceptions. The potato processing data indicate that linuron residues of concern concentrate in wet peel waste (processing factor of 5.5x), chips (2.0x), dehydrated granules (3.4x), and oven­ baked potatoes (2.1x), but do not concentrate in peeled potato (0.82x) or mashed potato (0.61x). The available soybean processing data indicate that residues were found to concentrate in soybean isolate (1.6x) and lecithin (2.3x). Cooking studies were available in asparagus, carrot and potato. These studies generally show a significant reduction in residues through cooking. Monitoring data are available from both the U. S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA). However, both monitoring programs report levels of linuron parent only. USDA and FDA do not look for residues of linuron metabolites convertible to 3,4 dichloroaniline, namely DCPU (3,4­ dichlorophenylurea) and DCPMU (3­( 3,4­ dichlorophenyl)­ 1­ methylurea). In USDA Pesticide Data Program information, the detection rate for linuron parent on carrots is approximately 35% and residues were frequently found as high as 0.2 and 0.3 ppm. However, these data cannot be used in dietary exposure assessment as they may underestimate the amount of residues of concern. The assessment will use field trial data, refined by percent of crop treated data, processing studies and residue reduction studies. Currently, the Pesticide Analytical Manual (PAM) Vol. II lists a colorimetric method (Method I) and a paper chromatographic method for the enforcement of tolerances for linuron residues. Both these methods determine linuron and all metabolites hydrolyzable to 3,4­ DCA and have limits of detection of 0.05 ppm. However, the registrants must propose a more updated data collection method as an enforcement method for plant and animal commodities. The current enforcement method, GC/ ECD, involves conversion to residues of 3,4­ DCA and therefore will detect residues of linuron and its metabolites. The LOQ is 0.01 ppm. This method is the same method used for data collection purposes for residues of diuron in/ on plant and animal commodities. Therefore, the reregistration requirements for residue analytical methods are not fulfilled. Residue data for linuron in/ on plant and animal commodities were collected using Method I (or modifications thereof) or a GC­ ECD method similar to Method I. The multi­ residue testing method is inadequate for detection of linuron and its metabolites in/ on plant and animal commodities it is able to identify linuron parent only and some of the metabolites of concern. No maximum residue limits (MRLs) for linuron have been established by Codex for any agricultural commodity. In addition, no Canadian or Mexican MRLs have been established for linuron. Therefore, no compatibility questions exist with respect to U. S. tolerances. 4.2.2 Acute Dietary ­ Females 13­ 50 Acute dietary (food) risk estimates associated with the use of linuron do not exceed the Agency's level of concern (> 100% of aPAD) for females 13­ 50 years of age. The acute dietary risk estimate for females 13­ 50 is approximately 10% of the aPAD. (Linuron Anticipated Residues and Dietary Exposure Assessment, DP Barcode D 279340, John Punzi, November 26, 2001.) 32 The acute dietary exposure assessment for linuron is a tier III probabilistic (Monte Carlo) analysis. Residue levels from USDA and FDA monitoring programs do not include all residues of concern needed for this assessment (linuron and metabolites converted to 3,4­ DCA) and would underestimate residue values. Anticipated residues (ARs) were computed from field trial data and subsequently utilized to estimate the acute dietary exposure to linuron in the diets of females 13­ 50. Percent crop treated (% CT) data, residue reduction data from washing, cooking and various processing studies were used as refinements to the residue data. Residue distribution files (RDFs) were generated for all nonblended commodities in the linuron dietary risk assessment incorporating the maximum percent of crop treated estimate as a representative number of `zeros' in the RDF. The linuron acute dietary exposure assessment was conducted using the Dietary Exposure Evaluation Model (DEEM™) software Version 7.73, which incorporates consumption data from USDA's Continuing Surveys of Food Intake by Individuals (CSFII), 1989­ 1992. The 1989­ 92 data are based on the reported consumption of more than 10,000 individuals over three consecutive days, and therefore represent more than 30,000 unique person days of data. Foods as consumed (e. g., apple pie) are linked to raw agricultural commodities and their food forms (e. g., apples­ cooked/ canned or wheat­ flour) by recipe translation files internal to the DEEM software. Consumption data are retained as individual consumption events for acute exposure assessment. For acute exposure assessments, individual one­ day food consumption data are used on an individual­ by­ individual basis. The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or matched in multiple random pairings with residue values and then summed in a probabilistic (Tier 3/ 4) assessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i. e., those who reported eating relevant commodities/ food forms) and a per­ capita (i. e., those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis. The acute population adjusted dose (aPAD) is calculated as the acute RfD divided by the FQPA safety factor. The calculated acute exposure (residue x consumption) was compared to an aPAD of 0.0403 mg/ kg­ bw/ day, which reflects an FQPA factor of 3x. The results are presented in Table 4. Table 4: Summary of Acute Dietary Exposure and Risk for Linuron Percentile of Exposure Population Subgroup: Females 13­ 50 Dietary Exposure (mg/ kg/ day) % aPAD 95th 0.000605 1.5 99th 0.001177 2.9 33 99.9th 0.003839 9.5 Uncertainties associated with this assessment include accuracy of the percent of crop treated estimates; the translation of the cooking/ processing factors across crops; and, the representativeness of the Continuing Survey of Food Intake by Individuals (CSFII) consumption survey. The Agency is confident, however, that the dietary exposures and risks anticipated through use of linuron in/ on plant and animals are not under­ estimated. 4.2.3 Chronic Dietary Chronic dietary (food) risk estimates associated with the use of linuron do not exceed the Agency's level of concern (> 100% cPAD) for any population subgroup including the most highly exposed subgroup, children 1­ 6 years. The chronic dietary risk for children ages 1­ 6 years is approximately 35% of the cPAD and approximately 15% for the general population. (Linuron Anticipated Residues and Dietary Exposure Assessment, DP Barcode D 279340, John Punzi January 15, 2002.) A refined (tier 3) analysis was done for the chronic dietary risk assessment. Residue levels from USDA and FDA monitoring programs do not include all residues of concern needed for this assessment (linuron and metabolites converted to 3,4­ dichloroanaline) and would underestimate residue values. Anticipated residues were computed from field trial data and subsequently utilized to estimate the dietary exposure to linuron of the general U. S. population, as well as certain population subgroups. Percent crop treated data, residue reduction data from washing, cooking and various processing studies were used as refinements to the residue data. Linuron chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model (DEEM™) software Version 7.73, which incorporates consumption data from USDA's Continuing Surveys of Food Intake by Individuals (CSFII), 1989­ 1992. Consumption data are averaged for the entire U. S. population and within population subgroups for chronic dietary exposure assessment. For chronic exposure and risk assessment, an estimate of the residue level in each food or foodform (e. g., orange or orange­ juice) on the commodity residue list is multiplied by the average daily consumption estimate for that food/ food form. The resulting residue consumption estimate for each food/ food form is summed with the residue consumption estimates for all other food/ food forms on the commodity residue list to arrive at the total estimated exposure. Exposure estimates are expressed in mg/ kg body weight/ day and as a percent of the cPAD. The chronic population adjusted dose (cPAD) is the chronic RfD divided by the FQPA safety factor. The calculated chronic exposure (residue x consumption) was compared to an cPAD of 0.00077 mg/ kg­ bw/ day, which reflects an FQPA factor of 10x. This procedure is performed for each population subgroup. 34 This assessment is a refined tier III analysis employing a number of residue correction factors to reflect realistic exposure levels in the diet. These include the application of percent of crop treated information and residue reduction studies. Uncertainties associated with this assessment include accuracy of the percent of crop treated estimates; the application of the cooking/ processing factors across crops; and, the representativeness of the CSFII consumption survey. The Agency is confident, however, that the exposures and risks anticipated through use of linuron on plant and animals is not under­ estimated. The chronic exposure estimates were less than 100% of the cPAD with the highest chronic exposure (0.00027 mg/ kg/ day) occurring in children 1­ 6 years old (35% of the cPAD). These results are presented in Table 5. Table 5: Chronic Dietary Exposure and Risk Values Population Subgroup Dietary Exposure (mg/ kg/ day) % cPAD U. S. Population 0.000114 14.8 All Infants (< 1 year) 0.000179 22.3 Children 1­ 6 years 0.000268 34.7 Children 7­ 12 years 0.000173 22.4 Females 13­ 50 years 0.000083 10.8 Males 13­ 19 years 0.000102 13.2 Males 20+ years 0.000088 11.4 Seniors 55+ years 0.000094 12.2 4.3 Water Exposure/ Risk Pathway The linuron drinking water exposure assessment is based upon review of environmental fate studies for parent linuron, modeling and monitoring results for parent linuron, and modeling results for the degradates of linuron based upon parent linuron model input parameters. Parent linuron appears to be moderately persistent and relatively immobile. Water degradates identified in the linuron aerobic soil metabolism study are desmethyl linuron, 3,4­ dichlorophenylurea or DCPU (norlinuron) and desmethoxy­ linuron (3­( 3,4­ dichlorophenyl)­ 1­ methylurea, DCPMU. The degradate 3,4­ dichloroaniline was not included in the water assessment as it was not detected in the aerobic soil metabolism study (0.01 ppm detection limit). According to acceptable fate studies, 3,4­ DCA is formed under anaerobic aquatic conditions rarely found in the environment and is not relevant to drinking water assessment. The environmental fate assessment for linuron is incomplete and tentative because information on the persistence, mobility and dissipation pathways of several degradates of linuron is not 35 available. However, none of the linuron water degradates are present at levels greater than 10% of the applied parent, and therefore not considered major water metabolites. With the information available, EFED believes linuron and its degradates have the potential to impact drinking water quality. (Drinking Water Assessment for Linuron metabolites on Carrots in California. Ibrahim Abdel­ Saheb. Environmental Fate and Effects Division. January 14, 2002.) 4.3.1 Environmental Fate There is a reasonable expectation that linuron parent and its metabolites would be found in drinking water. Increased mobility may occur under specific environmental conditions such as in coarse textured soils and soils with low levels of organic matter. Linuron dissipates principally by biotic processes such as microbial degradation. In surface soils with adequate organic matter, the combined processes of adsorption and microbial degradation would limit linuron's potential to migrate to groundwater. Linuron could runoff to surface water bodies. In that case, it would degrade fairly rapidly to desmethyl linuron, 3,4­ dichlorophenylurea (DCPU or norlinuron), and, desmethoxy­ linuron (3­( 3,4­ dichlorophenyl)­ 1­ methylurea (DCPMU). None of these water degradates is present in amounts greater than 10% of the applied radioactivity in the aerobic soil metabolism study. The available data on the major degradates of linuron are insufficient to assess their runoff potential or persistence in water. Linuron exhibits some of the properties and characteristics of chemicals that have been detected in ground water, and linuron itself has been detected in ground water in four states (Georgia, Missouri, Virginia and Wisconsin). Linuron is moderately persistent with an aerobic soil metabolism half­ life ranging from 57 to 100 days. Because parent linuron is sufficiently persistent and may be mobile under certain environmental conditions, it has the potential to impact ground water quality. Linuron can be applied aerially or by ground spray and therefore could contaminate surface waters through spray drift. It has the potential to be somewhat persistent in surface waters, particularly those with low microbiological activity and long hydrological residence times. Linuron degraded with a half­ life of less than 3 weeks in non­ sterile anaerobic silt loam and sand soil: water (1: 1) systems. It may be less persistent in water and sediment under anaerobic conditions than under aerobic conditions. Its bioconcentration potential is relatively low. Linuron is not currently regulated under the Safe Drinking Water Act, and water supply systems are not required to sample and analyze for it. The primary treatment processes employed by most water systems may not always be completely effective in removing linuron and its degradates. As a result, the Agency does have some moderate concerns regarding potential risks of linuron and these degradates to surface water source supply systems. 4.3.2 Drinking Water Exposure Estimates The Agency currently lacks sufficient water­ related exposure data from monitoring to complete 36 a quantitative drinking water exposure analysis and risk assessment for linuron and its degradates. Therefore, the Agency is presently relying on computer­ generated estimated environmental concentrations (EECs). The tier II screening model PRZM/ EXAMS is used to generate expected environmental concentrations (EECs) for surface water and SCI­ GROW (an empirical model based upon actual monitoring data collected for a number of pesticides that serve as benchmarks) predicts EECs in groundwater. These models take into account the use patterns and the environmental profile of a pesticide, but do not include consideration of the impact that processing raw water for distribution as drinking water could have on the removal or metabolism of pesticides from the source water. For any given pesticide, the SCI­ GROW model generates a single EEC value of pesticide concentration in ground water. That EEC is used in assessments of both acute and chronic dietary risk. It is not unusual for the ground water EEC to be significantly lower than the surface water EECs. PRZM/ EXAMS provides surface water annual daily maximum, an annual mean as well as 36­ year overall mean value of pesticide concentration in surface water and is used when a refined surface water EEC is needed. Surface Water The use of linuron on carrots in California was modeled for the purpose of assessing surface drinking water exposure to the chemical and its degradates. This use represents the greatest potential drinking water exposure. The Tier II screening models PRZM and EXAMS with the Index Reservoir and Percent Crop Area adjustment (IR­ PCA) were used to determine estimated surface water concentrations of linuron and linuron degradates. The IR­ PCA modeling results indicate that linuron and its degradates have the potential to contaminate surface waters by spray drift, and runoff in areas with large amounts of annual rainfall. Modeling results are higher than those from existing surface water monitoring data for linuron. EFED has limited monitoring data on the concentrations of linuron (parent only) in surface water and has no monitoring data on the concentrations of desmethyl linuron, desmethoxy linuron or nor linuron in surface water. EFED has limited fate and mobility data on these metabolites; thus, a combined residue approach was used to calculate their aerobic soil metabolism half­ lives (assuming equal toxicity) by the summation of the concentrations of the parent and its metabolites. The index reservoir represents a potentially vulnerable drinking water source based on the geometry of an actual reservoir and its watershed in a specific area (Illinois), using regional screening specific cropping patterns, weather, soils, and other factors. The PCA is a generic watershed­ based adjustment factor which represent the portion of a watershed planted to a crop or crops and will be applied to pesticide concentrations estimated for the surface water component of the drinking water exposure assessment using PRZM/ EXAMS with the index reservoir scenario. The IR­ PCA PRZM/ EXAMS inputs included modeling the use of linuron on carrots (greatest percent of crop treated estimate), a 14­ day interval between applications, and ground boom application, among other things. (" Drinking Water Assessment for Linuron on Carrots in California." Ibrahim Abdel­ Sahed, EFED, October 14, 2001.) 37 There are a number of inherent limitations with the water model used to estimate concentrations on linuron in surface water. Because the index reservoir represents a fairly vulnerable watershed, the estimated exposure may not reflect actual exposure for most drinking water sources. A single steady flow has been used to represent the flow through the reservoir and this assumption can underestimate or overestimate the concentration in the pond depending upon the annual precipitation pattern at the site. In addition, soils can vary substantially across even small areas, affecting residue concentrations in water, and this variation is not reflected in these simulations. Tile drainage is not specifically considered in the index­ reservoir of PRZM­ EXAMS. Tile drainage may cause either an increase or decrease in the pesticide concentration in the reservoir. Turnover occurs when the temperature drops in the fall and the thermal stratification of the reservoir is removed and EXAMS is unable to easily model spring and fall turnover. EFED assumes that the field scale processes simulated by the coupled PRZM and EXAMS models are a reasonable approximation of pesticide fate and transport within a watershed that contains a drinking water reservoir. However, available monitoring data suggest uneven model results. In addition, the use of input parameter values for the parent when assessing the linuron degradates increases the uncertainties in the assessment. All these limitations should be noted when evaluating exposure to linuron through surface water. Groundwater The Screening Concentration in Groundwater (SCI­ GROW) model was used to estimate groundwater concentrations for linuron and its degradates. The SCI­ GROW groundwater modeling result is lower than historical monitoring data for linuron presence in groundwater. The maximum observed concentration was 5.0 µg/ l as compared to the SCI­ GROW EEC of 0.78 µg/ l (combined residues). The recommended groundwater drinking water EECs is 5.0 µg/ l and is based upon monitoring data. Groundwater monitoring data were compiled from the 1992 USEPA Pesticide in Groundwater Database. Validated monitoring data for linuron sampled in Georgia, Missouri, Virginia, and Wisconsin were considered when selecting the EEC for groundwater. The highest concentration of linuron in groundwater is from a study in Georgia in which 67 out of 70 well results detected the presence of linuron. Monitoring data were also available from the USGS National Water Quality Assessment Program (NAWQA), however, the frequency and duration of sampling were not sufficient to represent an adequate monitoring data set for exclusive use in drinking water exposure determination. SCIGROW model results are substantially less than both surface water modeling and groundwater monitoring data indicate. Therefore, for drinking water concentrations from groundwater, EFED recommends an EEC value of 5.0 µg/ l derived from the results of groundwater monitoring studies for linuron parent. EFED also reviewed potential groundwater contamination by linuron degradates. EFED has no monitoring data on the concentrations of desmethyl linuron, desmethoxy linuron or nor linuron in groundwater at the present time. There is a possibility that those metabolites were not included in the 38 sampling, or they might have been present at concentrations lower than that of the instruments used for the water samples collected. The SCI­ GROW model was used to estimate potential groundwater concentrations of linuron water degradates. Groundwater EECs predicted using the SCI­ GROW screening model are substantially less than those estimated for surface water using PRZM and EXAMS. However, generally, persistence of linuron water degradates in groundwater should be longer. The values listed in Table 6 will be used in comparison to a drinking water level of comparison (DWLOC). Table 6. Estimated environmental concentrations in surface and groundwater for linuron use on carrots. model/ monitoring EECs (µg/ L) Linuron Desmethyl linuron Desmethoxy linuron Norlinuron Surface water/ peak (90 th percentile annual daily max.) 31.3 1.69 3.26 1.26 Surface water/ 90 th percentile annual mean) 12.5 1.60 3.10 1.20 Surface water/ 36­ year overall mean 7.31 1.17 2.28 0.88 Groundwater/ peak and long term average 0.54 0.047 0.094 0.035 Groundwater monitoring result 5.0* N/ A N/ A N/ A Use( s) modeled two applications on carrots @ 1.0 lb ai/ acre, ground application two applications on carrots @ 0.04 lb ai/ acre, ground application two applications on carrots @ 0.08 lb ai/ acre, ground application two applications on carrots @ 0.03 lb ai/ acre, ground application Percent Crop Area (PCA) Default PCA (0.87) * USEPA Pesticide in Groundwater Database, 1992 4.4 Residential Exposure/ Risk Pathway 39 There are currently no registered uses for linuron in the residential environment. However, the linuron label does include use of the chemical in rights­ of­ way areas and spray drift is always a potential source of exposure to residents nearby to this type of spraying operation. This is particularly the case with aerial application, but, to a lesser extent, could also be a potential source of exposure from groundboom application methods. The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and State Lead Agencies for pesticide regulation and other parties to develop the best spray drift management practices. The Agency is now requiring interim mitigation measures for aerial applications that must be placed on product labels/ labeling. The Agency has completed its evaluation of the new data base submitted by the Spray Drift Task Force, a membership of U. S. pesticide registrants, and is developing a policy on how to appropriately apply the data and the AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard airblast and ground hydraulic methods. After the policy is in place, the Agency may impose further refinements in spray drift management practices to reduce off­ target drift and risks associated with the application of linuron by aerial as well as other application types where appropriate. 5.0 Aggregate Risk Assessment and Risk Characterization The Food Quality Protection Act (FQPA) amendments to the Federal Food, Drug and Cosmetic Act requires for establishing or reassessing a pesticide tolerance "that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposure for which there is reliable information." The November 20 th , 2001 HIARC meeting resulted in endpoint selection for all exposure durations and routes, including the residential pathway. However, exposure is only expected to occur via the food and water pathways of exposure. If new uses are added to the label in the future which include possible exposure to persons in the residential environment, EPA will conduct this analysis. The toxicological endpoints appropriate for the dietary (oral) route of exposure are, therefore, the only hazard endpoints considered in this analysis. Acute and chronic aggregate risk is comprised of the combined exposures from food and water. Risk estimates are aggregated because it is assumed exposure may occur over the same time period. The HIARC selected an acute dietary endpoint for females 13­ 50 based upon increased postimplantation loss and fetal/ litter resorptions at the LOAEL seen in a developmental rat study. However, no appropriate effect attributed to a single exposure was identified in the toxicology database for the general population. The chronic dietary aggregate assessment will utilize an endpoint based on a chronic oral study in the dog which demonstrated an increased met­ and sulfhemoglobin level at the LOAEL. DWLOCs are used to estimate aggregate risk from drinking water sources. DWLOCs are theoretical upper limits of a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and drinking water. A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weight. HED uses DWLOC's internally in the risk assessment process as a surrogate measure of potential exposure associated with pesticide exposure 40 through drinking water. In the absence of reliable monitoring data for pesticides which can be used directly and quantitatively in the risk assessment, it is used as a point of comparison against conservative model estimates of a pesticide's concentration in water. DWLOC values are not a regulatory standard for drinking water. However, they do have an indirect regulatory impact through aggregate exposure and risk assessments. Risk estimates for food and water are summarized in Tables 7 and 8. The estimates of food exposure are considered to be highly refined since anticipated residues were generated for both the acute and chronic dietary exposure scenarios which includes incorporation of percent of crop treated values, processing factors, and reduction of residue information such as cooking and washing factors. In addition, for the acute dietary exposure assessment, a probabilistic approach was used. On March 13, 2002, the Registration Division informed the Health Effects Division of an Interregional Research Project number 4 (IR­ 4) request for additional tolerances for linuron. The two new uses are on rhubarb (0.5 ppm) and celeriac (1.0 ppm). When these two new uses are added to the dietary exposure assessment, there are no changes to the total exposure and, therefore, total dietary risk estimates for this chemical. Similarly, there are no changes expected to the total aggregate exposure and risk estimate. Therefore, there is a reasonable certainty that no harm will result from aggregate exposure to linuron when the new uses for rhubarb and celeriac are added to the list of crops on which the chemical may be used. 5.1 Acute Risk 5.1.1 Acute Aggregate Risk Assessment (Females 13­ 50) The acute aggregate exposure from residues of linuron and its metabolites in food and drinking water and do not exceed the Agency's level of concern. The calculated DWLOCs exceed the estimated drinking water concentrations. HED calculates DWLOCs by a two­ step process: exposure is subtracted from the PAD to obtain the maximum exposure allowed in drinking water; DWLOCs are then calculated using that value and HED default body weight and drinking water consumption figures. In assessing human health risk, DWLOCs are compared to EECs. When EECs are less than DWLOCs, HED considers the aggregate risk [from food + water exposures] to be acceptable. Estimated environmental concentrations for linuron and its water degradates were compared to the acute DWLOCs since adequate monitoring data were not available. EFED provided Tier II PRZM­ EXAMS with Index Reservoir and Percent Crop Area adjustment (IR­ PCA PRZM­ EXAMS) estimates to determine acute dietary aggregate exposure and risk values. This model simulated linuron drinking water concentrations (for the carrot use) of 38 µg/ L for the surface water peak annual daily maximum for linuron and its degradates in water. The SCI­ GROW model was used to estimate concentrations of linuron and its degradates in groundwater (0.76 µg/ L), however, EFED recommended that the groundwater drinking water EEC of 5.0 µg/ L determined through groundwater monitoring 41 studies be used. This is because the model estimate is an order of magnitude below the monitoring estimate. The DWLOC calculated for acute aggregate risk for females 13­ 50 is 1085 µg/ L. These results are presented in Table 7. Therefore, HED concludes with reasonable certainty that residues of linuron and its metabolites in drinking water will not contribute significantly to the acute human health risk and that the acute aggregate exposure from residues of linuron and its metabolites in food and drinking water and will not exceed the Agency's level of concern for acute aggregate exposure for females 13­ 50. 5.1.2 Acute DWLOC Calculations Table 7. Acute DWLOC Calculations Population Subgroup 1 Acute Scenario aPAD mg/ kg/ day Acute Food Exp mg/ kg/ day Max Acute Water Exp mg/ kg/ day 1 Ground Water EEC (ppb) 2 Surface Water EEC (µg/ l) 2 Acute DWLOC (µg/ L) 3 Females 13­ 50 0.0403 0.003839 4 0.036461 5 38 1085 1 Maximum acute water exposure (mg/ kg/ day) = [( acute PAD (mg/ kg/ day) ­ acute food exposure (mg/ kg/ day)] 2 The crop producing the highest level was used for the surface water EEC and groundwater monitoring results are used for the groundwater EEC. 3 Acute DWLOC( µg/ L) = [maximum acute water exposure (mg/ kg/ day) x body weight (kg)] [water consumption (L) x 10 ­3 mg/ µg] 4 Acute food exposure is exposure estimate at the 99.9th percentile from the Monte Carlo assessment performed. Assumptions: Body weights (60 kg adult female); water consumption 2 liters/ day adult. 5.2 Chronic Risk 5.2.1 Chronic Aggregate Risk Assessment Chronic aggregate exposure from residues of linuron and its metabolites in food and drinking water from surface water sources exceeds the Agency's level of concern for chronic aggregate exposure for infants and children. Calculated DWLOCs are below the drinking water exposure estimates. EFED provided Tier II PRZM­ EXAMS with Index Reservoir and Percent Crop Area adjustment (IR­ PCA PRZM­ EXAMS) to determine chronic dietary aggregate exposure and risk values. This model simulated drinking water concentrations of linuron and its degradates (for the carrot use) of 18.4 µg/ L for the surface water annual mean. The SCI­ GROW model was used to estimate concentrations of linuron in groundwater (0.76 µg/ L), however, EFED recommended that the groundwater drinking water EEC of 5.0 µg/ L determined through groundwater monitoring studies be used. Because the model estimate is an order of magnitude below the monitoring estimate, the Agency is using the results of the monitoring data assure exposure and risks are conservatively assessed. As shown in Table 8, the DWLOCs calculated for chronic aggregate risk range from 6 µg/ L for infants and children to 23 µg/ L for the general population and females 13­ 50. The chronic aggregate 42 risk calculations show that the EEC of linuron in surface drinking water exceed the allowable levels of linuron in drinking water based upon the DWLOC value for the infants and children sub­ groups. Therefore, residues of linuron and its metabolites in drinking water may represent a chronic human health risk and that the chronic aggregate exposure from residues of linuron and its metabolites in food and drinking water exceeds the Agency's level of concern for chronic aggregate exposure for infants and children. The degree to which the EEC exceeds the calculated DWLOC is slight, but it does represent the best information HED has to assess chronic aggregate exposure and risk to linuron. An immediate conclusion of safety cannot be made for the population subgroups of infants and children 1­ 6 since the DWLOC is less than the estimated EECs. However, since the EEC estimates are based on upper­ end input parameters such as the maximum application rate, the assessment indicates a need to refine the drinking water exposure estimates by attaining additional information about the persistence and mobility of linuron water degradates. The issues will be considered by the Agency as part of linuron tolerance reassessment. 5.2.2 Chronic DWLOC Calculations Table 8. Chronic DWLOC Calculations Population Subgroup 1 Chronic Scenario cPAD mg/ kg/ day Chronic Food Exp mg/ kg/ day Max Chronic Water Exp mg/ kg/ day 2 Ground Water EEC (ppb) 3 Surface Water EEC (µg/ L) 3 Chronic DWLOC (µg/ L) U. S. Population 0.00077 0.00011 0.00066 5 18 23 Females 13­ 50 0.00077 0.000083 0.00069 5 18 23 Infants (< 1 year) 0.00077 0.00018 0.00059 5 18 6 Children 1­ 6 0.00077 0.00027 0.0005 5 18 6 1 Children 1­ 6 are the most highly exposed sub­ group. 2 Maximum Chronic Water Exposure (mg/ kg/ day) = [Chronic PAD (mg/ kg/ day) ­ Chronic Dietary Exposure (mg/ kg/ day)] 3 The use of linuron on carrots was modeled to determine surface water EEC's and the results of groundwater monitoring study was used to determined groundwater EEC. 4 Chronic DWLOC( µg/ L) = [maximum chronic water exposure (mg/ kg/ day) x body weight (kg)] [water consumption (L) x 10 ­3 mg/ µg] Assumptions: Body weights (70 kg adult male; 60 kg adult female; 10 kg child); water consumption 2 liters/ day adult and 1 liter/ day infants and children. 6.0 Cumulative Risk The Food Quality Protection Act (1996) stipulates that when determining the safety of a pesticide chemical, EPA shall base its assessment of the risk posed by the chemical on, among other things, available information concerning the cumulative effects to human health that may result from 43 dietary, residential, or other non­ occupational exposure to other substances that have a common mechanism of toxicity. The reason for consideration of other substances is due to the possibility that low­ level exposures to multiple chemical substances that cause a common toxic effect by a common mechanism could lead to the same adverse health effect as would a higher level of exposure to any of the other substances individually. A person exposed to a pesticide at a level that is considered safe may in fact experience harm if that person is also exposed to other substances that cause a common toxic effect by a mechanism common with that of the subject pesticide, even if the individual exposure levels to the other substances are also considered safe. HED did not perform a cumulative risk assessment as part of the TRED for linuron because HED has not yet initiated a comprehensive review to determine if there are any other chemical substances that have a mechanism of toxicity common with that of linuron. For purposes of this TRED, EPA has assumed that linuron does not have a common mechanism of toxicity with other substances. On this basis, the registrant must submit, upon EPA's request and according to a schedule determined by the Agency, such information as the Agency directs to be submitted in order to evaluate issues related to whether linuron shares a common mechanism of toxicity with any other substance and, if so, whether any tolerances for linuron need to be modified or revoked. If HED identifies other substances that share a common mechanism of toxicity with linuron, HED will perform aggregate exposure assessments on each chemical, and will begin to conduct a cumulative risk assessment. HED has developed a framework for conducting cumulative risk assessments on substances that have a common mechanism of toxicity. This guidance was issued on January 16, 2002 (67 FR 2210­ 2214) and is available from the OPP Website at: http:// www. epa. gov/ pesticides/ trac/ science/ cumulative_ guidance. pdf. In the guidance, it is stated that a cumulative risk assessment of substances that cause a common toxic effect by a common mechanism will not be conducted until an aggregate exposure assessment of each substance has been completed. Before undertaking a cumulative risk assessment, HED will follow procedures for identifying chemicals that have a common mechanism of toxicity as set forth in the "Guidance for Identifying Pesticide Chemicals and Other Substances that Have a Common Mechanism of Toxicity" (64 FR 5795­ 5796, February 5, 1999). 7.0 Incident Data The Agency searched several databases for reports of poisoning incident data for linuron. These databases include the OPP Incident Data System, the Poison Control Centers database, the California Department of Pesticide Regulation, and the National Pesticide Telecommunications Network. Relatively few incidents of illness have been reported. Three cases were submitted to the California Pesticide Illness Surveillance Program (1982­ 1999) concerning possible linuron poisoning. Effects reported in these cases include chemical conjuctivitis when linuron was splashed into the eyes, 44 headache, nausea, swollen tongue and blurred vision, and itchy hives. According to the fifth edition of "Recognition and Management of Pesticide Poisonings" (EPA 1999), systemic toxicity is unlikely unless large amounts have been ingested. No recommendations can be made based on the few incident reports available for linuron. (" Review of Linuron Incident Reports." # 035506 Jerome Blondell, January 11, 2002.). 8.0 Data Needs Product Chemistry 1. The product chemistry data base is complete. Toxicology 2. A developmental neurotoxicity study is required for linuron due to concern for neuro­ endocrine disruption. And, a 28­ day inhalation study in the rat is required. Residue Chemistry 3. A review of the product labels and the supporting residue data indicate that the following label amendments are required: The product labels include directions for use for a number of tank mixes. In many cases, the tank mix products are no longer registered for use on the subject crop. Inappropriate tank mix recommendations are noted in Table 2 of "Linuron Tolerance Reassessment Eligibility Decision Residue Chemistry Considerations." (DP Barcode 272368) A number of grazing/ feeding restriction are considered to be impractical by HED and must be removed from the appropriate product labels. Several crops/ use directions require PHIs to be specified. Product labels which contain use directions for asparagus must be modified to make it clear that the maximum combined application rate is 4.0 lb ai/ A/ season when more than one type of application (preemergence, postemergence, or application at the fern stage) is made. The product label for EPA Reg. No. 1812­ 245 includes two tables of application rates at the end of the soybean use directions which are titled "Soybeans: Broadcast Application ­ Linex 4L and Sencor DF and Lasso" and "Soybeans: Broadcast 45 Application ­ Linex 4L and Sencor DF and Duel 8E." The label should be modified to clarify application timing for these tables; it is not clear to which application type preemergence or post­ emergence) these application rates pertain. 4. The reregistration requirements for residue analytical methods are not fulfilled. The registrants must propose the current data collection method, a GC/ ECD method, as an enforcement method for plant and animal commodities to replace the outdated colorimetric enforcement method. 5. The reregistration requirements for storage stability are not fulfilled. The final reports for ongoing storage stability studies on cotton processed commodities, and sweet corn commodities must be submitted. In addition, information pertaining to sample storage intervals and conditions for samples of parsnips and for the animal feeding studies are required. 6. The reregistration requirements for magnitude of the residue in plants are not fulfilled for: celery; corn, field, aspirated grain fractions; corn, sweet (K+ CWHR); corn, sweet, forage; corn, sweet, stover; sorghum forage and stover; wheat forage, hay, and straw. Additional crop field trial data and/ or information is required for these commodities. 7. Tolerances for linuron residues of concern in milk must be proposed. Environmental Fate 8. Two environmental fate data requirements are not fulfilled. They are a Leaching/ Adsorption/ Desorption study and a Terrestrial Field Dissipation study. 46 References: Linuron. Product Chemistry Chapter for the Tolerance Renewal Eligibility Decision (TRED) Document. DP Barcode D273274. Ken Dockter. October 1, 2001. LINURON ­ Report of the Hazard Identification Assessment Review Committee. (HED Doc. No. 0050286) Robert Fricke. November 20, 2001. LINURON (PC code 035506) Toxicology Disciplinary Chapter for the Tolerance Reassessment Eligibility Decision Document. Robert Fricke. DP Barcode D272367 January 30, 2002. Linuron. Anticipated Residues and Dietary Exposure Assessment (PC Code 035506). John Punzi. DP Barcode D279340. January 15, 2002. Linuron Tolerance Reassessment Eligibility Decision Residue Chemistry Considerations. (DP Barcode D272368) John Punzi. November 26, 2001. Linuron Plant and Animal Metabolism: Results of the HED Metabolism Committee Meetings held October 21 and October 29, 1993. Dennis McNeilly. November 17, 1993. Drinking Water Assessment for Linuron on Carrots in California. Ibrahim Abdel­ Saheb. Environmental Fate and Effects Division. October 14, 2001. Drinking Water Assessment for Linuron metabolites on Carrots in California. Ibrahim Abdel­ Saheb. Environmental Fate and Effects Division. January 14, 2002. Quantitative Usage Analysis for Linuron. Frank Hernandez. August 18, 2000. Review of Linuron Incident Reports. Chemical 035506. Jerome Blondell. January 11, 2002. Linuron ­ Report of the FQPA Safety Factor Committee. Carol Christensen. December 6, 2001. DIURON: The HED Chapter of the Reregistration Eligibility Decision Document (RED). PC Code: 035505. Case 0046. DP Barcode D272130. Diana Locke. December 2002. Reregistration Eligibility Decision: Linuron. EPA No. 738­ R­ 95­ 003. March 1995.

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Supporting & Related Material

N Cl Cl O N O 10­ 01­ 01 MEMORANDUM SUBJECT: Linuron. List A Reregistration Case 0047. PC Code 035506. Product Chemistry Chapter for the Tolerance Renewal Eligibility Decision [TRED] Document. DP Barcode D273274. FROM: K. Dockter, Chemist Reregistration Branch 2 Health Effects Division [7509C] THRU: Alan Nielsen, Branch Senior Scientist Reregistration Branch 2 Health Effects Division [7509C] TO: Carol Christensen, Risk Assessor Reregistration Branch 2 Health Effects Division [7509C] Linuron [3­( 3,4­ dichlorophenyl)­ 1­ methoxy­ 1­ methylurea] is registered for selective weed control in many crops, and on roadsides, and fence rows. Empirical formula: C9H10Cl2N2O2 Molecular weight: 249.1 CAS Registry No.: 330­ 55­ 2 PC Code: 035506 Chemical structure by J. Punzi The Reregistration Standard [RS] issued 6/ 30/ 82, the Guidance 6/ 29/ 84, & the Update [U] 6/ 20/ 90. The Reregistration Eligibility Decision Document issued 3/ 96. A search of REFS conducted 9/ 25/ 01 identified 26 active products, 5 of which are technicals [Ts] subject to a TRED. The Ts are identified in Table 1. Table 1. Technical Linuron Active Products EPA Reg. No. Registrant Product Name % a. i. CSF Date 1812­ 270 Griffin Corp. Griffin Linuron Technical 96.25 9/ 28/ 90 1812­ 411 " L. L. C. DuPont Linuron Flake Technical 97.0 12/ 20/ 95 19713­ 158 Drexel Chml. Co. Drexel " " " 95 10/ 1/ 98 " ­367 " " Linuron Technical I 95.0 1/ 4/ 99 " ­368 " " " " II " 10/ 1/ 98 The product chemistry data base is complete. The Series 830 physical and chemical properties are given in the table below. GLN MRID Data 6302 Color 460023­ 045 off­ white to light tan 6303 Physical state " solid 6304 Odor " odorless 7200 MP " 93 ­ 94 C 7300 Bulk density " 1.45 g/ cc 7840 Water solubility " 75 ppm @ 25 C 7950 vp " 1.5 x 10 ­5 mm Hg @ 24 C 7550 log Pow " 2.76 6313 Stability " stable up to MP; stable at concentrations of 5 & 5000 ppm in aqueous buffers [pH 5, 7, & 9] for 30 days @ 20 C. cc: RF, Dockter, C. Christensen, J. Punzi, R. Fricke. RD\ I RRB2 Linuron TRED Team. 7509C: RRB2: Rm712N: 57886: KD/ kd Linuron. TRED [987] = D273274. mem.

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EPA-HQ-OPP-2002-0079-0004

Supporting & Related Material

Quantitative Usage Analysis for Linuron Case Number: 0047 PC Code: 35506 Date: October 22, 2001 Analyst: Frank Hernandez Based on available usage information from pesticide surveys for the years of 1992 through 2000, total annual domestic usage of linuron averaged approximately over four hundred thousand pounds of active ingredient (a. i.) for just under four hundred thousand acres treated. Linuron is a herbicide with its largest markets in terms of total pounds of active ingredient allocated to carrots (35%), potatoes (20%), and cotton (17%). Most of the usage is in IL, IN, MD, MI, OH, and WA. Crops with a high percentage of the total U. S. planted acres treated include carrots (75%), celery (24%), asparagus (20%), and potatoes (7%). Crops with less than 1 percent of the crop treated include alfalfa, barley, dry beans, corn, cotton, lettuce, melons, peanuts, rice, rye, sorghum, soybeans, sweet corn, and wheat. Site Acres Grown (000) Acres Treated (000) % of Crop Treated LB AI Applied (000) Average Application Rate States of Most Usage Wtd Avg Est Max Wtd Avg Est Max Wtd Avg Est Max lb ai/ A/ yr #appl / yr lb ai/ A/ appl (% of total lb ai used on this site) Alfalfa 23,701 1 4 0.00 0.02 1 2 0.7 1.0 0.7 MO KS CA 100% Asparagus 90 18 30 20.39 33.29 18 36 1.0 1.0 1.0 CA WA 85% Barley 7,326 0 0 0.00 0.00 0 0 0.5 1.0 0.5 ID MT ND 85% Beans/ Peas, Dry 2,190 3 12 0.14 0.54 2 10 0.8 2.5 0.3 OH WA 88% Beans/ Peas, Green 709 1 2 0.10 0.28 0 1 0.4 1.0 0.4 MN MD 80% Carrots 104 79 104 75.31 100.00 145 210 1.8 1.0 1.8 CA MI FL WA TX 83% Celery 34 8 11 23.67 32.54 4 8 0.5 1.0 0.5 MI CA TX 84% Corn 72,425 7 10 0.01 0.01 15 29 2.1 1.3 1.7 KY NC OH IN PA MI 58% Cotton 12967 88 233 0.68 1.80 72 123 0.8 1.0 0.8 MS AR SC NC LA TN 83% Site Acres Grown (000) Acres Treated (000) % of Crop Treated LB AI Applied (000) Average Application Rate States of Most Usage Wtd Avg Est Max Wtd Avg Est Max Wtd Avg Est Max lb ai/ A/ yr #appl / yr lb ai/ A/ appl (% of total lb ai used on this site) Lettuce 274 2 8 0.61 2.98 1 5 0.6 1.0 0.6 CA FL 86% Melons 375 1 2 0.25 0.5051 1 2 1.0 1.0 1.0 TX 89% Oats/ Rye 6,184 0 1 0.01 0.01 0 1 0.7 1.0 0.7 ME MI 93% Parsley 5 0 0 3.00 6.00 0 2 2.7 3.5 0.8 CA 60% Parsnips 4 0 0 1.55 2.33 0 0 1.0 1.0 1.0 CA FL 70% Peanuts 1,582 0 1 0.03 0.06 1 1 1.1 1.0 1.1 SC FL 100% Potatoes 1,433 100 158 6.98 11.03 85 180 0.8 1.0 0.8 ND MI RI ME NY MN 71% Rice 2,992 5 20 0.18 0.66 3 13 0.5 1.1 0.5 TX CA LA 91% Rye 4,364 0 1 0.01 0.02 0 1 0.7 1.0 0.7 ME MI 93% Sorghum 11,140 33 107 0.30 0.96 13 52 0.4 1.0 0.4 TX KS 80% Soybeans 63,141 25 41 0.04 0.07 53 100 2.1 1.1 2.0 MI OH IN MD IL VA 67% Sweet Corn 732 3 10 0.47 1.37 4 8 1.19 1.6 0.8 PA MA OH 81% Wheat, Spring 21,311 0 2 0.00 0.01 0 1 0.5 1.0 0.5 MN 100% Wheat, Winter 44,907 7 13 0.01 0.03 3 6 0.4 2.0 0.2 MD MS DE AL WA TN 78% Total 383 577 421 605 COLUMN HEADINGS Wtd Avg = Weighted average­­ the most recent years and more reliable data are weighted more heavily. Est Max = Estimated maximum, which is estimated from available data. Average application rates are calculated from the weighted averages. NOTES ON TABLE DATA Usage data primarily covers 1992 ­ 2000. Calculations of the above numbers may not appear to agree because they are displayed as rounded to the nearest 1000 for acres treated or lb. a. i. (therefore 0 = < 500), and to two decimal percentage points for % of crop treated. Other/ Crop Groups Melons include cantaloupe, watermelon, honeydew, muskmelon, and winter melon. SOURCES: EPA data, USDA, and National Center for Food and Agricultural Policy. cc: JSPunzi (RRB2), Linuron Reg. Std. File, Linuron SF, RF, LAN. RD/ I: RRB2 Chem Review Team (12/ 10/ 2001), Alan Nielsen (12/ 30/ 2001), ChemSac (12/ 12/ 2001), DeSac (12/ 18/ 2001). 7509C: RRB2: John S. Punzi: CM2: Rm 804E: 703­ 305­ 7727: 12/ 20/ 2001.

epa

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regulations

EPA-HQ-OPP-2002-0079-0005

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES January 11, 2001 MEMORANDUM SUBJECT: Review of Linuron Incident Reports DP Barcode D280196, Chemical #035506 FROM: Jerome Blondell, Ph. D., Health Statistician Chemistry and Exposure Branch 1 Health Effects Division (7509C) Monica F. Spann, M. P. H., Environmental Health Scientist Chemistry and Exposure Branch 1 Health Effects Division (7509C) THRU: Francis B. Suhre, Senior Scientist Chemistry and Exposure Branch 1 Health Effects Division (7509C) TO: Carol Christiansen, Environmental Protection Specialist Reregistration Branch 2 Health Effects Division (7509C) BACKGROUND The following data bases have been consulted for the poisoning incident data on the active ingredient Linuron (PC Code: 035506): 1) OPP Incident Data System (IDS) ­ reports of incidents from various sources, including registrants, other federal and state health and environmental agencies and individual consumers, submitted to OPP since 1992. Reports submitted to the Incident Data System represent anecdotal reports or allegations only, unless otherwise stated. Typically no conclusions can be drawn implicating the pesticide as a cause of any of the reported health effects. Nevertheless, sometimes with enough cases and/ or enough documentation risk mitigation measures may be suggested. 2 2) Poison Control Centers ­ as the result of a data purchase by EPA, OPP received Poison Control Center data covering the years 1993 through 1998 for all pesticides. Most of the national Poison Control Centers (PCCs) participate in a national data collection system, the Toxic Exposure Surveillance System which obtains data from about 65­ 70 centers at hospitals and universities. PCCs provide telephone consultation for individuals and health care providers on suspected poisonings, involving drugs, household products, pesticides, etc. 3) California Department of Pesticide Regulation ­ California has collected uniform data on suspected pesticide poisonings since 1982. Physicians are required, by statute, to report to their local health officer all occurrences of illness suspected of being related to exposure to pesticides. The majority of the incidents involve workers. Information on exposure (worker activity), type of illness (systemic, eye, skin, eye/ skin and respiratory), likelihood of a causal relationship, and number of days off work and in the hospital are provided. 4) National Pesticide Telecommunications Network (NPTN) ­ NPTN is a toll­ free information service supported by OPP. A ranking of the top 200 active ingredients for which telephone calls were received during calendar years 1984­ 1991, inclusive has been prepared. The total number of calls was tabulated for the categories human incidents, animal incidents, calls for information, and others. LINURON REVIEW I. Incident Data System Please note that the following cases from the IDS do not have documentation confirming exposure or health effects unless otherwise noted. Incident# 2796­ 239 Only one report in the Incident Data System involved linuron mixed with another herbicide. The health effects reported in this case could not be attributed to linuron. II. Poison Control Center Data ­ 1993 through 1998 No data. III. California Data ­ 1982 through 1999 Detailed descriptions of 3 cases submitted to the California Pesticide Illness Surveillance Program (1982­ 1999) were reviewed. In the first case, a worker, who removed their eye protection, reported chemical conjunctivitis after the product splashed into their eyes while preparing to rinse a container. The individual was hospitalized for five days. In the second case, a foreman of a crew 3 thinning head lettuce reported nausea, headache, swollen tongue and lips, and blurred vision. In the third case, a farm worker reported severe itchy hives on the trunk, neck, and arms while collecting bundles of asparagus and delivering them to a packing shed. Only cases with a definite, probable or possible relationship were reviewed. Linuron ranked 216 th as a cause of systemic poisoning in California based on data for 1982 through 1999. IV. National Pesticide Telecommunications Network On the list of the top 200 chemicals for which NPTN received calls from 1984­ 1991 inclusively, linuron was ranked 171 st with 15 incidents in humans reported and 1 in animals (mostly pets). V. Conclusions Relatively few incidents of illness have been reported due to linuron. According to the fifth edition of "Recognition and Management of Pesticide Poisonings" (EPA 1999), systemic toxicity is unlikely unless large amount have been ingested. Linuron and other substituted ureas are known to be irritating to eyes, skin, and mucous membranes as evidenced by the cases reported in California. VI. Recommendations No recommendations can be made based on the few incident reports available. cc: Correspondence Linuron file (chemical no. 035506) Tom Myers, SRRD ­ (7508C)

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regulations

EPA-HQ-OPP-2002-0079-0006

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM 11/ 26/ 2001 Subject: Linuron Tolerance Reassessment Eligibility Decision Residue Chemistry Considerations. Reregistration Case No.: 0047 PC Code: 035506 DP Barcode No.: 272368 FROM: John S. Punzi, Ph. D., Chemist Reregistration Branch II Health Effects Division [7509C] THROUGH: Alan Nielsen, Branch Senior Scientist Reregistration Branch II Health Effects Division [7509C] TO: Tom Myers, Chemical Review Manager Special Review and Reregistration Division [7508C] Attached is a review of the Linuron Tolerance Reassessment Eligibility Decision Residue Chemistry Considerations. The Residue Chemistry Chapter for the Linuron Reregistration Eligibility Document (RED) was published 2/ 18/ 94. An Addendum to the Linuron Residue Chemistry RED Chapter was issued on 2/ 21/ 95. This updated review (post­ FQPA) of the available residue chemistry database was completed by the Dynamac Corporation under supervision of HED and has undergone secondary review/ modification in Reregistration Branch 2 for consistency with current EPA policies. Conclusions/ Recommendations The residue chemistry database is incomplete. 1. A review of the product labels and the supporting residue data indicate that the following label amendments are required: ° The product labels include directions for use for a number of tank mixes. In many cases, the tank mix products are no longer registered for use on the subject crop. Inappropriate tank mix recommendations are noted in Table 2. ° A number of grazing/ feeding restriction are considered to be impractical by HED and must be removed from the appropriate product labels. ° Several crops/ use directions require preharvest intervals (PHIs) to be specified. ° Product labels which contain use directions for asparagus must be modified to make it clear that the maximum combined application rate is 4.0 lb ai/ A/ season when more than one type of application (preemergence, postemergence, or application at the fern stage) is made. ° The product label for EPA Reg. No. 1812­ 245 includes two tables of application rates at the end of the soybean use directions which are titled "Soybeans: Broadcast Application ­ Linex 4L and Sencor DF and Lasso" and "Soybeans: Broadcast Application ­ Linex 4L and Sencor DF and Duel 8E." The label should be modified to clarify application timing for these tables; it is not clear to which application type (preemergence or postemergence) these application rates pertain.. 2. The reregistration requirements for residue analytical methods are not fulfilled. The registrants must propose the current data collection method, a GC/ ECD method, as an enforcement method for plant and animal commodities to replace the current colorimetric enforcement method, which is outdated. 3. The reregistration requirements for storage stability are not fulfilled. The final reports for ongoing storage stability studies on cotton gin byproducts, cotton processed commodities, and sweet corn commodities must be submitted. In addition, information pertaining to sample storage intervals and conditions for samples of parsnips and for the animal feeding studies are required (MRIDs 00018209, 00018210, 00018375, 00018383, 00018450, and 00018775). 4. The reregistration requirements for magnitude of the residue in plants are not fulfilled for: celery; corn, field, aspirated grain fractions; corn, sweet (K+ CWHR); corn, sweet, forage; corn, sweet, stover; cotton gin byproducts; sorghum forage and stover; wheat forage, hay, and straw. Additional crop field trial data and/ or information is required for these commodities. 5. Tolerances for linuron residues of concern in milk must be proposed. cc: JSPunzi (RRB2), Linuron Reg. Std. File, Linuron SF, RF, LAN. RD/ I: RRB2 Chem Review Team (01/ 26/ 2001), Alan Nielsen (11/ 30/ 2001). 7509C: RRB2: John S. Punzi: CM2: Rm 804E: 703­ 305­ 7727: 11/ 26/ 2001. LINURON PC Code 035506; Case 0047 Tolerance Reassessment Eligibility Decision Residue Chemistry Considerations September 26, 2001 Contract No. 68­ W­ 99­ 053 Submitted to: U. S. Environmental Protection Agency Arlington, VA Submitted by: Dynamac Corporation 20440 Century Boulevard, Suite 100 Germantown, MD 20874 LINURON TOLERANCE REASSESSMENT ELIGIBILITY DECISION RESIDUE CHEMISTRY CONSIDERATIONS PC Code 035506; Case 0047 TABLE OF CONTENTS page A. INTRODUCTION ........................................................ 1 B. USE PATTERN SUMMARY ............................................... 1 1. Product List ......................................................... 1 2. Use Pattern Table .................................................... 2 C. SUMMARY OF RESIDUE CHEMISTRY DATA REQUIREMENTS ............... 24 D. RESIDUE CHARACTERIZATION .......................................... 32 General Discussion on Residue Chemistry of Linuron .............................. 32 1. Nature of the Residue in Plants .......................................... 32 2. Nature of the Residue in Livestock ....................................... 34 3. Residue Analytical Methods ............................................ 35 4. Multiresidue Method Testing ........................................... 36 5. Storage Stability Data ................................................ 36 6. Magnitude of the Residue in Crop Plants .................................. 38 Root and Tuber Vegetables Group ....................................... 38 Leafy Vegetables Group .............................................. 39 Legume Vegetables Group ............................................. 41 Foliage of Legume Vegetables Group ..................................... 41 Cereal Grain Group .................................................. 41 Forage, Fodder, and Straw of Cereal Grains Group .......................... 44 Miscellaneous Commodities ............................................ 46 7. Magnitude of the Residue in Processed Food/ Feed ........................... 47 Corn, field ......................................................... 47 Cotton ............................................................ 48 Potato ............................................................ 48 Sorghum, grain ...................................................... 49 Soybean .......................................................... 49 Wheat ............................................................ 49 8. Magnitude of the Residue in Meat, Milk, Poultry, and Eggs ..................... 49 9. Reduction of Residues ................................................ 52 3 10. Confined and Field Accumulation in Rotational Crops ......................... 52 E. TOLERANCE REASSESSMENT SUMMARY ................................ 53 1. Tolerance Reassessments for Linuron ..................................... 53 Tolerances Listed Under 40 CFR §180.184( a) ............................. 53 Tolerances To Be Proposed Under 40 CFR §180.184( a) ..................... 54 Tolerances Listed Under 40 CFR §180.184( c) ............................. 54 Tolerances To Be Proposed Under 40 CFR §180.184( c) ..................... 54 Pending Tolerance Petitions ............................................ 54 2. Tolerance Reassessment Table .......................................... 56 3. Codex/ International Harmonization ....................................... 59 F. BIBLIOGRAPHY ....................................................... 60 1. Study Citations ..................................................... 60 2. Agency Memoranda Citations .......................................... 67 LINURON TOLERANCE REASSESSMENT ELIGIBILITY DECISION RESIDUE CHEMISTRY CONSIDERATIONS PC Code 035506; Case 0047 A. INTRODUCTION Linuron [3­( 3,4­ dichlorophenyl)­ 1­ methoxy­ 1­ methylurea] is a selective herbicide that is classified as a nonquantifiable Group C carcinogen. Linuron, which is formulated as dry flowable (DF) or flowable concentrate (FlC) formulations, is currently registered by Griffin Corporation, Drexel Chemical Company, and Micro­ Flo Company for pre­ or postemergence use on asparagus, carrot, celery, field corn, sweet corn, cotton, parsley, parsnip, potato, sorghum, soybean, and winter wheat. The nature of the residue in plants and animals is adequately understood based on plant metabolism studies on corn, soybeans, and potatoes and animal metabolism studies on goats and poultry. Currently tolerances for plant and animal commodities are expressed in terms of linuron per se. The HED Metabolism Committee has determined that the residues of concern are linuron and its metabolites convertible to 3,4­ dichloroaniline, expressed as linuron (D. McNeilly, 11/ 17/ 93); residues of 3,4­ dichloroaniline per se need not be regulated separately. The Residue Chemistry Chapter for the Linuron Reregistration Eligibility Document (RED) was published 2/ 18/ 94. An Addendum to the Linuron Residue Chemistry RED Chapter was issued on 2/ 21/ 95. The Residue Chemistry Chapter of the Linuron Reregistration Standard was issued 6/ 30/ 82, and the Residue Chemistry Chapter of the Linuron Reregistration Standard Update was issued 6/ 20/ 90. B. USE PATTERN SUMMARY 1. Product List A search of the Agency's Reference Files System (REFS) on 6/ 14/ 01 indicates that there are five linuron end­ use products (EPs) registered to Griffin Corporation, Drexel Chemical Company, and Micro­ Flo Company that have uses on food and/ or feed crops (Table 1). At the time of the 02/ 94 RED, there were 15 linuron EPs with food/ feed uses; these were registered to E. I. du Pont de Nemours and Company, Griffin Corporation, Drexel Chemical Company, Platte Chemical Company, and Micro­ Flo Company. Since the 2/ 94 RED, all the Dupont EPs have been canceled except for one EP (EPA Reg. No. 352­ 394) which was transferred to Griffin Corporation (EPA Reg. No. 1812­ 417) and then subsequently canceled. In addition, one Drexel EP (EPA Reg. No. 19713­ 79) and one Platte EP (EPA Reg. No. 34704­ 703) have been canceled. There are 13 SLN registrations with food/ feed uses associated with linuron. 2 Table 1. Linuron EPs with Uses on Feed/ Food Crops Registered to Griffin Corporation, Drexel Chemical Company, and Micro­ Flo Company. EPA Reg. No. Label Acceptance Date Formulation Class Product Name Griffin Corporation 1812­ 245 a 3/ 27/ 98 4 lb/ gal FlC Linex® 4L Herbicide 1812­ 320 b 4/ 15/ 99 50% DF Lorox® DF Drexel Chemical Company 19713­ 97 5/ 17/ 94 4 lb/ gal FlC c Linuron 4L Weed Killer 19713­ 251 4/ 1/ 94 50% DF Linuron DF Herbicide Micro­ Flo Company 51036­ 78 12/ 22/ 93 4 lb/ gal FlC Linuron 4L Weed Killer a Including SLN Nos. AL000002, AR000007, LA000013, MS000003, TN000005, and TX000012. b Including SLN Nos. AR000008, CO970001, ID970004, LA000015, MS000011, TN000006, and WA000036. c Product formulation is listed as emulsifiable concentrate (EC) in REFs; however, upon examination of the product label, the formulation should be classified as a flowable concentrate (FlC). 2. Use Pattern Table A comprehensive summary of the registered use patterns of linuron, based on the product labels registered to Griffin Corporation, Drexel Chemical Company, and Micro­ Flo Company, is presented in Table 2. A tabular summary of the residue chemistry science assessments for reregistration of linuron is presented in Table 3. The conclusions listed in Table 3 regarding the tolerance reassessment eligibility are based on the use patterns registered by the basic producers, Griffin Corporation and Drexel Chemical Company. When end­ use product DCIs are developed, RD should require that all end­ use product labels (e. g., MAI labels, SLNs, and products subject to the generic data exemption) be amended such that they are consistent with the basic producers' labels. A review of the above EP labels and the supporting residue data indicate that the following label amendments are required: ° The product labels include directions for use for a number of tank mixes. In many cases, the tank mix products are no longer registered for use on the subject crop. The following tank mix recommendations must be removed from all relevant product labels: chloramben on any crop (no currently registered chloramben products); dinoseb on any crop (no currently registered dinoseb products); oryzalin on soybeans; and propachlor on soybeans. Also, the product labels for the 50% DF formulations (1812­ 320 and 19713­ 251) include tank mix recommendations for 3 Bronco®, a product which was cancelled 3/ 9/ 00. Inappropriate tank mix recommendations are highlighted in Table 2. ° The following grazing/ feeding restriction are considered to be impractical by HED and must be removed from the appropriate product labels: restrictions against the grazing or feeding of treated sorghum forage or silage to dairy animals (EPA Reg. Nos. 1812­ 320, 19713­ 97, 19713­ 251, and 51036­ 78); restrictions against the feeding of cotton gin trash to livestock (EPA Reg. Nos. 1812­ 245, 19713­ 251, and 51036­ 78 as well as SLN Nos. AL000002, AR0000007, AR000008, LA000013, LA000015, MS000001, MS000011, TN000005, TN000006, and TX000012); and restrictions against the grazing/ feeding of immature wheat plants to livestock (EPA Reg. Nos. 1812­ 245, 19713­ 97, and 51036­ 78). ° The following crops/ use directions require preharvest intervals (PHIs) to be specified: postemergence uses on sorghum (EPA Reg. Nos. 1812­ 245, 1812­ 320, 19713­ 97, 19713­ 251, and 51036­ 78); application to newly planted or direct­ seeded asparagus (EPA Reg. Nos. 1812­ 245, 1812­ 320, 19713­ 97, 19713­ 251 and SLN No. ID970004); postemergence application to carrots grown in NY (EPA Reg. Nos. 1812­ 245 and 1812­ 320); postemergence application to field corn (EPA Reg. Nos. 1812­ 245, 19713­ 97, 19713­ 251, and 51036­ 78); posttransplant application to celery (EPA Reg. No. 1812­ 245, 1812­ 320, 19713­ 97, 19713­ 251, and 51036­ 78); and postemergence application to cotton (EPA Reg. Nos. 1812­ 245, 19713­ 251, and 51036­ 78 as well as SLN Nos. AL000002, AR0000007, AR000008, LA000013, LA000015, MS000001, MS000011, TN000005, TN000006, and TX000012). ° Product labels which contain use directions for asparagus must be modified to make it clear that the maximum combined application rate is 4.0 lb ai/ A/ season when more than one type of application (preemergence, postemergence, or application at the fern stage) is made. In addition, the available crop field trial data for asparagus are sufficient to support application of linuron to asparagus in all areas of the U. S. Therefore, the registrants may wish to modify product labels to remove the restrictions limiting use on asparagus to certain states. ° The product label for EPA Reg. No. 1812­ 245 includes two tables of application rates at the end of the soybean use directions which are titled "Soybeans: Broadcast Application ­ Linex 4L and Sencor DF and Lasso" and "Soybeans: Broadcast Application ­ Linex 4L and Sencor DF and Duel 8E." The label should be modified to clarify application timing for these tables; it is not clear to which application type (preemergence or postemergence) these application rates pertain. 4 (continued; footnotes follow) Table 2. Food/ Feed Use Patterns Subject To Reregistration for Linuron (PC Code 035506). Site Application Type Application Timing Application Equipment Formulation [EPA Reg. No.] Single Application Rate, lb ai/ A Maximum Number of Applications Maximum Seasonal Application Rate, ai Preharvest Interval, days Use Limitations 1 Asparagus Soil broadcast or band Direct seeded or newly planted crowns Preemergence (after planting) Ground 4 lb/ gal FlC [1812­ 245] 1.0­ 2.0 1 2.0 Not specified (NS) Use limited to CA, MI, MN, NC, OR, and WA for a single preemergence application and up to two postemergence applications (when ferns are 6­ 18 inches) to direct seeded or newly planted crowns. Direct seeded or newly planted crowns Postemergence Ground 0.5­ 1.0 2 NS Soil broadcast or band Direct seeded or newly planted crowns Preemergence (after planting) Ground 50% DF [1812­ 320] [ID970004] 1.0­ 2.0 1 2.0 NS Use limited to CA, HI, ID, MI, MN, NC, ND, NJ (preemergence only), OR, WA, and WI for a single preemergence application and up to two postemergence applications (when ferns are 6­ 18 inches) to direct seeded or newly planted crowns. Direct seeded or newly planted crowns Postemergence Ground 0.5­ 1.0 2 NS Soil broadcast or band Direct seeded or newly planted crowns Preemergence (after planting) Ground 4 lb/ gal FlC [19713­ 97] 50% DF [19713­ 251] 1.0­ 2.0 1 2.0 NS Use limited to CA for a single preemergence application and up to two postemergence applications (when ferns are 6­ 18 inches) to direct seeded or newly planted crowns. Direct seeded or newly planted crowns Postemergence 0.5­ 1.0 2 NS Table 2 (continued). Site Application Type Application Timing Application Equipment Formulation [EPA Reg. No.] Single Application Rate, lb ai/ A Maximum Number of Applications Maximum Seasonal Application Rate, ai Preharvest Interval, days Use Limitations 1 5 (continued; footnotes follow) Asparagus (continued) Established beds Preemergence (after planting) Ground 4 lb/ gal FlC [1812­ 245] 1.0­ 2.0 1 4.0 NS Use limited to CA, MI, MN, NC, OR, and WA for a single preemergence application and up to four postemergence applications (before cutting season or immediately after cutting) to established beds. A one year PBI has been established for any other crop if more than 2.0 lb ai/ A/ season is applied. Established beds Postemergence Ground 0.5­ 1.0 4 1 Established beds Preemergence (after planting) Ground 4 lb/ gal FlC [19713­ 97] 50% DF [19713­ 251] 1.0­ 2.0 1 4.0 NS Use limited to CA for a single preemergence application and up to four postemergence applications (before cutting season or immediately after cutting) to established beds. Established beds Postemergence Ground 0.5­ 1.0 4 1 Established beds Preemergence (after planting) Ground 50% DF [1812­ 320] 1.0­ 2.0 1 2.0 NS Use limited to CA, HI, ID, MI, MN, NC, ND, NJ preemergence only), OR, WA, and WI for a single preemergence application and up to three postemergence applications (before cutting season or immediately after cutting) to established beds. Established beds Postemergence Ground 0.5­ 1.0 3 1 Established beds Preemergence (after planting) Ground 50% DF [ID970004] 1.0­ 2.0 1 4.0 NS Use limited to ID for a single preemergence application and up to four postemergence applications (before cutting season or immediately after cutting) to established beds. A one year PBI has been established for any other crop if more than 2.0 lb ai/ A/ season is applied. Established beds Postemergence Ground 0.5­ 1.0 4 1 Table 2 (continued). Site Application Type Application Timing Application Equipment Formulation [EPA Reg. No.] Single Application Rate, lb ai/ A Maximum Number of Applications Maximum Seasonal Application Rate, ai Preharvest Interval, days Use Limitations 1 6 (continued; footnotes follow) Asparagus (continued) Directed spray Postharvest Ground 4 lb/ gal FlC [1812­ 245] 2.0­ 4.0 1 4.0 NS Use limited to CA, MI, MN, NC, OR, and WA for a single postemergence directed spray application to the base of plant in the fern stage. A one year PBI has been established for any other crop if more than 2.0 lb ai/ A/ season is applied. 50% DF [1812­ 320] 2.0 1 2.0 NS Use limited to CA, HI, ID, MI, MN, NC, ND, NJ (preemergence only), OR, WA, and WI for a single postemergence directed spray application to the base of plant in the fern stage. 4 lb/ gal FlC [19713­ 97] 50% DF [19713­ 251] 2.0­ 4.0 1 4.0 NS Use limited to CA for a single postemergence directed spray application to the base of plant in the fern stage. A one year PBI has been established for any other crop if more than 2.0 lb ai/ A/ season is applied. 50% DF [ID970004] 2.0­ 4.0 1 4.0 NS Use limited to ID for a single postemergence directed spray application to the base of plant in the fern stage. A one year PBI has been established for any other crop if more than 2.0 lb ai/ A/ season is applied. Table 2 (continued). Site Application Type Application Timing Application Equipment Formulation [EPA Reg. No.] Single Application Rate, lb ai/ A Maximum Number of Applications Maximum Seasonal Application Rate, ai Preharvest Interval, days Use Limitations 1 7 (continued; footnotes follow) Carrot Preemergence (after planting) Ground 4 lb/ gal FlC [1812­ 245] 0.5­ 1.5 1 1.5 NS Use limited to FL, MI, NJ, OH, and WI. 4 lb/ gal FlC [19713­ 97] 0.5­ 1.0 for FL 0.5­ 1.5 for MI, OH, and WI 1 1.0 (FL) 1.5 (MI, OH, and WI) 14 Use limited to FL, MI, OH, and WI. 50% DF [19713­ 251] 0.5­ 1.0 for FL 0.5­ 1.5 for MI and WI 1 1.0 (FL) 1.5 (MI and WI) 14 Use limited to FL, MI, and WI. 50% DF [1812­ 320] 0.5­ 1.0 for CA, FL, MN, ND, OR, and WA 0.5­ 1.5 for MI, OH, and WI 1 1.0 (CA, FL, MN, ND, OR, and WA) 1.5 (MI, OH, and WI) 14 Use limited to CA, FL, MI, MN, ND, OH, OR, WA, and WI. 4 lb/ gal FlC [51036­ 78] 0.5­ 1.5 1 1.5 14 Use limited to MI and WI. Table 2 (continued). Site Application Type Application Timing Application Equipment Formulation [EPA Reg. No.] Single Application Rate, lb ai/ A Maximum Number of Applications Maximum Seasonal Application Rate, ai Preharvest Interval, days Use Limitations 1 8 (continued; footnotes follow) Carrots (continued) Postemergence Ground 4 lb/ gal FlC [1812­ 245] [19713­ 97] 50% DF [1812­ 320] [19713­ 251 0.75­ 1.5 NS 2.0 1.5 (west of Rocky Mountains) 14 Multiple foliar applications for use in the entire U. S. Postemergence applications are to be made after carrots reach 3 inches in height. Maximum seasonal rate includes preemergence applications, if made. 4 lb/ gal FlC [51036­ 78] 0.75­ 1.5 NS 2.0 14 4 lb/ gal FlC [1812­ 245] 50% DF [1812­ 320] 0.125­ 0.25 NS NS NS Use limited to NY for multiple broadcast applications made postemergence. Applications may be made at lower rate when carrots have at least one fully developed true leaf or at the higher rate to carrots having three or more leaves. Preemergence (after planting) Ground 50% DF [CO970001] 0.125­ 0.25 1 2.0 14 Use limited to CO. Additional postemergence applications may be made as long as the total application rate does not exceed 2.0 lb ai/ A/ season. Celery Foliar Posttransplant Ground 4 lb/ gal FlC [1812­ 245] 50% DF [1812­ 320] 0.75­ 1.5 1 1.5 NS Use allowed in all states except CA. Application is to be made before celery reaches 8 inches in height. 0.75­ 1.0 1 1.0 NS Use limited to CA. Application is to be made before celery reaches 8 inches in height. 50% DF [19713­ 251] 4 lb/ gal FlC [19713­ 97] [51036­ 78] 0.75­ 1.5 1 1.5 NS Use limited to east of the Rocky Mountains. Application is to be made before celery reaches 8 inches in height. Table 2 (continued). Site Application Type Application Timing Application Equipment Formulation [EPA Reg. No.] Single Application Rate, lb ai/ A Maximum Number of Applications Maximum Seasonal Application Rate, ai Preharvest Interval, days Use Limitations 1 9 (continued; footnotes follow) Corn, field Preemergence (after planting) Ground 4 lb/ gal FlC [1812­ 245] Sandy loam soils: 0.3­ 1.0 1 1.0 NS Use limited to east of the Rocky Mountains. A single preemergence application may be made as a tank mix with alachlor (Lasso®), propachlor (EPA Nos. 19713­ 97 and 51036­ 78 only), or atrazine. Silt loam soils: 0.5­ 1.25 1 1.25 Clay loam soils: 0.6­ 1.5 1 1.5 Preemergence (after planting) Ground 50% DF [1812­ 320] Sandy loam soils: 0.33­ 0.75 1 0.75 NS Use limited to east of the Rocky Mountains. A single preemergence application may be made as a tank mix with alachlor (Lasso®), propachlor (Ramrod®), or atrazine. Loam, silt loam, silt, sandy clay, sandy clay loam soils: 0.5­ 0.75 Silty clay, silty clay loam, clay, clay loam soils: 0.6­ 0.75 50% DF [19713­ 251] Sandy loam soils: 0.3­ 1.0 1 1.0 NS Use limited to east of the Rocky Mountains. A single preemergence application may be made as a tank mix with alachlor, propachlor, or atrazine. Loam, silt loam, silt, sandy clay, sandy clay loam soils: 0.5­ 1.5 1.5 Silty clay, silty clay loam, clay, clay loam soil: 0.625­ 1.5 1.5 Table 2 (continued). Site Application Type Application Timing Application Equipment Formulation [EPA Reg. No.] Single Application Rate, lb ai/ A Maximum Number of Applications Maximum Seasonal Application Rate, ai Preharvest Interval, days Use Limitations 1 10 (continued; footnotes follow) Corn, field (continued) Directed spray Postemergence Ground 4 lb/ gal FlC [1812­ 245] [19713­ 97] [51036­ 78] 0.625­ 1.5 1 1.5 NS A single postemergence directed (to weeds) spray application to field corn at least 15 inches in height. 50% DF [19713­ 251] 0.625 1 0.625 NS Corn, sweet Directed spray Postemergence Ground 4 lb/ gal FlC [19713­ 97] [51036­ 78] 0.625­ 1.5 1 1.5 NS A single postemergence directed (to weeds) spray application to sweet corn at least 15 inches in height. 50% DF [19713­ 251] 0.625 1 0.625 NS Cotton Directed spray Postemergence Ground 4 lb/ gal FlC [1812­ 245] [51036­ 78] [MS000003] 50% DF [19713­ 251] 0.5­ 0.75 2 1.5 (implied) NS Use limited to east of the Rocky Mountains for one or two postemergence directed (to weeds) spray applications made after cotton is at least 15 inches tall. Feeding forage or gin trash from treated areas to livestock and grazing treated fields are prohibited. Directed spray After last cultivation (layby) Ground 1.0­ 1.5 1 1.5 NS Use limited to east of the Rocky Mountains for a single postemergence directed (to weeds) spray application made after the last cultivation (layby) when cotton is at least 20 inches tall. Feeding forage or gin trash from treated areas to livestock and grazing treated fields are prohibited. Table 2 (continued). Site Application Type Application Timing Application Equipment Formulation [EPA Reg. No.] Single Application Rate, lb ai/ A Maximum Number of Applications Maximum Seasonal Application Rate, ai Preharvest Interval, days Use Limitations 1 11 (continued; footnotes follow) Cotton (continued) Directed spray Postemergence Ground 4 lb/ gal FlC [AL010001] [AR000007] [LA000013] [TN000005] [TX000012] 50% DF [AR000008] [LA000015] [MS000011] [TN000006] 0.5­ 0.75 2 1.5 (implied) NS Use limited to AL, AR, LA, MS, TN, and TX for one or two postemergence directed spray applications made after cotton is at least 8 inches tall. Feeding forage or gin trash from treated areas to livestock and grazing treated fields are prohibited. Directed spray After last cultivation (layby) Ground 1.0­ 1.5 1 1.5 NS Use limited to AL, AR, LA, MS, TN, and TX for a single postemergence directed spray application made after the last cultivation (layby) when cotton is at least 20 inches tall. Feeding forage or gin trash from treated areas to livestock and grazing treated fields are prohibited. Parsley Preemergence (after planting) Ground 50% DF [1812­ 320] Mineral and muck soils: 0.5­ 1.5 1 1.5 30 Use limited to east of the Mississippi River and Texas. Postemergence Ground Muck soils only: 0.5 1 30 Use limited to east of the Mississippi River and Texas. Application should be made after parsley has a minimum of three true leaves. Parsnip Preemergence (after planting) Ground 4 lb/ gal FlC [1812­ 245] [19713­ 97] [51036­ 78] 50% DF [1812­ 320] [19713­ 251] 0.75­ 1.5 1 1.5 NS Table 2 (continued). Site Application Type Application Timing Application Equipment Formulation [EPA Reg. No.] Single Application Rate, lb ai/ A Maximum Number of Applications Maximum Seasonal Application Rate, ai Preharvest Interval, days Use Limitations 1 12 (continued; footnotes follow) Potato Preemergence (after planting) Ground or aerial 4 lb/ gal FlC [1812­ 245] Lighter soils (sandy loams, silty loams): 0.75­ 1.25 1 1.25 NS Use limited to east of the Rocky Mountains for a single preemergence application. Application must be made in a minimum of 3 gal/ A when using aerial equipment. Heavier soils (silts, clay loams): 1.25­ 2.0 1 2.0 NS Sand soil: 0.5 1 0.5 NS Use limited to WI (central sands area) for a single preemergence application. Loamy sand soil: 1.0 1 1.0 NS Coarse soils (sandy loam): 0.5­ 1.0 1 1.0 NS Use limited to the Northeast. A single preemergence application may be made as a tank mix with metolachlor (Dual 8E). Medium soils (loam, silt loam, silt, sandy clay, sandy clay loam): 0.75­ 1.25 1 1.25 NS Table 2 (continued). Site Application Type Application Timing Application Equipment Formulation [EPA Reg. No.] Single Application Rate, lb ai/ A Maximum Number of Applications Maximum Seasonal Application Rate, ai Preharvest Interval, days Use Limitations 1 13 (continued; footnotes follow) Potato (continued) Preemergence (after planting) Ground 4 lb/ gal FlC [19713­ 97] [51036­ 78] Coarser soils (sandy loam, silt loam): 0.75­ 1.25 1 1.25 NS Use limited to east of the Rocky Mountains for a single preemergence application. Finer soils (silts, clay loams): 1.25­ 2.0 1 2.0 NS Sand soil: 0.5 1 0.5 NS Use limited to WI (central sands area) for a single preemergence application. Loamy sand soil: 1.0 1 1.0 NS 50% DF [19713­ 251] Coarser soils (sandy loam, silt loam): 0.75­ 1.25 1 1.25 NS Use limited to east of the Rocky Mountains for a single preemergence application. Finer soils (silts, clay loams): 1.25­ 2.0 1 2.0 NS Sand soil: 0.5 1 0.5 NS Use limited to WI (central sands area) for a single preemergence application. Loamy sand soil: 1.0 1 1.0 NS Coarse soils (sandy loam): 0.5­ 1.0 1 1.0 NS Use limited to Northeast. A single preemergence application may be made as a tank mix with metolachlor. Medium soils (loam, silt loam, silt, sandy clay, sandy clay loam): 0.75­ 1.25 1 1.25 NS Table 2 (continued). Site Application Type Application Timing Application Equipment Formulation [EPA Reg. No.] Single Application Rate, lb ai/ A Maximum Number of Applications Maximum Seasonal Application Rate, ai Preharvest Interval, days Use Limitations 1 14 (continued; footnotes follow) Potato (continued) Preemergence (after planting) Ground 50% DF [1812­ 320] Coarse soils (sandy loam, silt loam): 0.75­ 1.25 1 1.25 NS Use limited to east of the Rocky Mountains for a single preemergence application. Fine soils (silts, clay loams): 1.25­ 1.5 1 1.5 NS Coarse soils (sandy loam): 0.5­ 1.0 1 1.0 NS Use limited to Northeast. A single preemergence application may be made as a tank mix with metolachlor (Dual 8E). Medium soils (loam, silt loam, silt, sandy clay, sandy clay loam): 0.75­ 1.25 1 1.25 NS Sorghum Preemergence (after planting) Ground 4 lb/ gal FlC [1812­ 245] Sandy loam soils: 0.3­ 0.75 1 0.75 90 PGI 2 Rotating to fall crops, sugar beets, tobacco, potatoes or other vegetables following treated sorghum crop is prohibited. Loam, silt loam, silt, sandy clay or sandy clay loam: 0.5­ 1.0 1 1.0 Directed spray Postemergence Ground 0.5­ 1.0 1 1.0 90 PGI A single postemergence directed (to weeds) spray application to sorghum. Application may be made at lower rate when sorghum is at least 12 inches in height or at the higher rate when sorghum is at least 15 inches tall. Rotating to fall crops, sugar beets, tobacco, potatoes or other vegetables following treated sorghum crop is prohibited. Table 2 (continued). Site Application Type Application Timing Application Equipment Formulation [EPA Reg. No.] Single Application Rate, lb ai/ A Maximum Number of Applications Maximum Seasonal Application Rate, ai Preharvest Interval, days Use Limitations 1 15 (continued; footnotes follow) Sorghum (continued) Preemergence (after planting) Ground 50% DF [1812­ 320] Sandy loam soils: 0.25­ 0.75 1 0.75 NS For use as a tank mix with registered herbicides. Grazing or feeding sorghum forage or silage from treated fields to dairy animals is prohibited. Rotating to fall crops, sugar beets, tobacco, potatoes or other vegetables following treated sorghum crop is prohibited. 3 Loam, silt loam, silt, sandy clay, or sandy clay loam soils: 0.5­ 1.0 1 1.0 NS Directed spray Postemergence Ground 0.5­ 1.0 1 1.0 NS A single postemergence directed (to weeds) spray application to sorghum. Application may be made at lower rate when sorghum is at least 12 inches in height or at the higher rate when sorghum is at least 15 inches tall. Grazing or feeding sorghum forage or silage from treated fields to dairy animals is prohibited. Rotating to fall crops, sugar beets, tobacco, potatoes or other vegetables following treated sorghum crop is prohibited. 3 Table 2 (continued). Site Application Type Application Timing Application Equipment Formulation [EPA Reg. No.] Single Application Rate, lb ai/ A Maximum Number of Applications Maximum Seasonal Application Rate, ai Preharvest Interval, days Use Limitations 1 16 (continued; footnotes follow) Sorghum (continued) Preemergence (after planting) Ground 4 lb/ gal FlC [19713­ 97] [51036­ 78] Sandy loam soils: 0.3­ 0.75 1 0.75 NS Use limited to the Southwest. A single preemergence application may be made as a tank mix with propazine. The rotation of treated sorghum with any fall crop or with sugar beets, tobacco, potatoes, or vegetables is prohibited. Silt loam, clay loam soils: 0.5­ 1.0 1 1.0 Sandy loam soils: 0.3­ 1.0 1 1.0 NS Use limited to the Great Plains. A single preemergence application may be made as a tank mix with propachlor. The grazing or feeding of sorghum forage or silage from treated fields to dairy animals is prohibited. Silt loam soils: 0.5­ 1.25 1 1.25 NS Clay loam soils: 0.6­ 1.5 1 1.5 NS Directed spray Postemergence Ground 0.5­ 1.0 1 1.0 90 PGI A single postemergence directed (to weeds) spray application to sorghum. Application may be made at the lower rate when sorghum is at least 12 inches in height or at the higher rate when sorghum is at least 15 inches tall. Table 2 (continued). Site Application Type Application Timing Application Equipment Formulation [EPA Reg. No.] Single Application Rate, lb ai/ A Maximum Number of Applications Maximum Seasonal Application Rate, ai Preharvest Interval, days Use Limitations 1 17 (continued; footnotes follow) Sorghum (continued) Preemergence (after planting) Ground 50% DF [19713­ 251] Sandy loam soils: 0.3­ 1.0 1 1.0 NS Use limited to the Great Plains. A single preemergence application may be made as a tank mix with propachlor. The grazing or feeding of sorghum forage or silage from treated fields to dairy animals is prohibited. Loam, silt loam, silt, sandy clay, sandy clay loam soils: 0.5­ 1.25 1 1.25 NS Silty clay, silty clay loam, clay, clay loam soils: 0.6­ 1.5 1 1.5 NS Directed spray Postemergence Ground 0.5­ 1.0 1 1.0 90 PGI A single postemergence directed (to weeds) spray application to sorghum. Application may be made at lower rate when sorghum is at least 12 inches in height or at the higher rate when sorghum is at least 15 inches tall. Soybean Conventional tillage systems Preemergence (after planting) Ground or aerial 4 lb/ gal FlC [1812­ 245] Sandy loam soils: 0.1­ 1.5 1 1.5 NS Application may be made alone or as a tank mix with alachlor (Lasso®; use limited east of the Rocky Mountains), metolachlor (Dual 8E), pendimethalin (Prowl®), or metribuzin (Lexone® DF). Application must be made in a minimum of 3 gal/ A when using aerial equipment. Feeding of treated forage to livestock is prohibited following tank mix use with Dual 8E. Loam, silt loam, silt, sandy clay, sandy clay loam soils: 0.25­ 2.0 1 2.0 NS Silty clay, silty clay loam, clay, clay loam soils: 0.4­ 3.0 1 3.0 NS Table 2 (continued). Site Application Type Application Timing Application Equipment Formulation [EPA Reg. No.] Single Application Rate, lb ai/ A Maximum Number of Applications Maximum Seasonal Application Rate, ai Preharvest Interval, days Use Limitations 1 18 (continued; footnotes follow) Soybean (continued) Conventional tillage systems Preemergence (after planting) Ground 4 lb/ gal FlC [19713­ 97] Sandy loam soils: 0.3­ 1.5 1 1.5 NS Application may be made alone or as a tank mix with alachlor, chloramben, metolachlor, oryzalin (Surflan®), pendimethalin (Prowl®), or propachlor (seed crop only). Feeding of treated forage to livestock is prohibited following tank mix use with metolachlor, oryzalin, or propachlor. Silt loam soils: 0.5­ 2.0 1 2.0 NS Clay loam soils: 0.6­ 3.0 1 3.0 NS 50% DF [19713­ 251] Sandy loam soils: 0.3­ 1.5 1 1.5 NS Application may be made alone or as a tank mix with alachlor, metolachlor, or metribuzin. Feeding of treated forage to livestock is prohibited following tank mix use with metolachlor. A 40­ day PGI has been established for tank mix use with alachlor. Loam, silt loam, silt, sandy clay, sandy clay loam soils: 0.5­ 2.0 1 2.0 NS Silty clay, silty clay loam, clay, clay loam soils: 0.6­ 3.0 1 3.0 NS 50% DF [1812­ 320] Coarse soils (sandy loam): 0.2­ 1.0 1 1.0 NS Application may be made alone or as a tank mix with alachlor (Lasso®), metolachlor (Dual 8E), or metribuzin (Lexone® DF). Grazing or feeding forage from treated areas to livestock is prohibited. Medium soils (loam, silt loam, silt, sandy clay, sandy clay loam): 0.25­ 1.0 1 1.0 NS Fine soils (silty clay, silty clay loam, clay, clay loam): 0.4­ 1.0 1 1.0 NS Table 2 (continued). Site Application Type Application Timing Application Equipment Formulation [EPA Reg. No.] Single Application Rate, lb ai/ A Maximum Number of Applications Maximum Seasonal Application Rate, ai Preharvest Interval, days Use Limitations 1 19 (continued; footnotes follow) Soybean (continued) Conventional tillage systems Preemergence (after planting) Ground 4 lb/ gal FlC [51036­ 78] Sandy loam soils: 0.3­ 1.5 1 1.5 NS Application may be made alone or as a tank mix with alachlor (Lasso®), chloramben, and propachlor (Ramrod®; seed crop only). Grazing or feeding of treated forage to livestock is prohibited following tank mix use with propachlor. Silt loam soils: 0.5­ 2.0 1 2.0 NS Clay loam soils: 0.6­ 3.0 1 3.0 NS Minimum or no­ tillage systems Preemergence (before, during, or after planting) Ground or aerial 4 lb/ gal FlC [1812­ 245] Sandy loam soils: 0.3­ 1.0 1 1.0 NS Tank mix use with paraquat or glyphosate. To improve control of grasses and volunteer small grains, tank mix may be combined with alachlor (Lasso®) or metolachlor (Dual 8E). Application must be made in a minimum of 3 gal/ A when using aerial equipment. The grazing or feeding of treated forage to livestock is prohibited. Silt loam soils: 0.5­ 1.25 1 1.25 NS Clay loam soils: 0.6­ 1.5 1 1.5 NS Minimum or no­ tillage systems Preemergence (before, during, or after planting) Ground 4 lb/ gal FlC [19713­ 97] Sandy loam soils: 0.3­ 1.0 1 1.0 NS Tank mix use with paraquat or glyphosate. To improve control of grasses and volunteer small grains, tank mix may be combined with alachlor, metolachlor, or oryzalin (Surflan®). Feeding of treated forage to livestock is prohibited following tank mix use with metolachlor or oryzalin. Silt loam soils: 0.5­ 1.25 1 1.25 NS Clay loam soils: 0.6­ 1.5 1 1.5 NS 50% DF [19713­ 251] Sandy loam soils: 0.3­ 1.5 1 1.5 NS Application may be made alone or as a tank mix with paraquat or glyphosate. To improve control of grasses and volunteer small grains, tank mix may be combined with alachlor, metolachlor, or oryzalin. Feeding of treated forage to livestock is prohibited following tank mix use with metolachlor or oryzalin. Loam, silt loam, silt sandy clay, sandy clay loam soils: 0.5­ 2.0 1 2.0 NS Table 2 (continued). Site Application Type Application Timing Application Equipment Formulation [EPA Reg. No.] Single Application Rate, lb ai/ A Maximum Number of Applications Maximum Seasonal Application Rate, ai Preharvest Interval, days Use Limitations 1 20 (continued; footnotes follow) Silty clay, silty clay loam, clay, clay loam soils: 0.6­ 3.0 1 3.0 NS Table 2 (continued). Site Application Type Application Timing Application Equipment Formulation [EPA Reg. No.] Single Application Rate, lb ai/ A Maximum Number of Applications Maximum Seasonal Application Rate, ai Preharvest Interval, days Use Limitations 1 21 (continued; footnotes follow) Soybean (continued) Minimum or no tillage systems Directed spray Postemergence Ground 4 lb/ gal FlC [1812­ 245] 0.5­ 1.0 2 1.0 60 Use limited to Midsouth and Southeast. Application is to be directed to weeds. For single application, application may be made at lower rate when soybean is at least 8 inches in height (Midsouth) or at the higher rate when soybean is at least 12 inches tall (Southeast). For split applications, the first application may be made when soybean is 12 inches tall with a 7­ day retreatment interval. Feeding of treated forage or hay to livestock is prohibited. 0.5 2 1.0 (implied) 60 Tank mix use with 2,4­ DB. Application may be made when soybean is at least 8 inches in height. 4 lb/ gal FlC [19713­ 97] 0.5­ 1.0 1 1.0 60 For single application, application may be made at lower rate when soybean is at least 8 inches in height or at the higher rate when soybean is at least 12 inches tall. For split applications, the first application may be made when soybean is 12 inches tall with a 7­ day retreatment interval. Feeding of treated forage or hay to livestock is prohibited. 0.5 2 1.0 0.5 2 1.0 NS Tank mix use with 2,4­ DB or dinoseb. Conventional, minimum, or no tillage systems Directed spray Postemergence Ground 50% DF [19713­ 251] 0.5­ 1.0 1 1.0 60 For single application, application may be made at lower rate when soybean is at least 8 inches in height or at the higher rate when soybean is at least 12 inches tall. For split applications, the first application may be made when soybean is 12 inches tall with a 7­ day retreatment interval. Feeding of treated forage or hay to livestock is prohibited. 0.5 2 1.0 (implied) 0.5 2 1.0 (implied) 60 Tank mix use with 2,4­ DB. Feeding of treated forage or hay to livestock is prohibited. Table 2 (continued). Site Application Type Application Timing Application Equipment Formulation [EPA Reg. No.] Single Application Rate, lb ai/ A Maximum Number of Applications Maximum Seasonal Application Rate, ai Preharvest Interval, days Use Limitations 1 22 (continued; footnotes follow) Soybean (continued) Conventional tillage systems Directed spray Postemergence Ground 4 lb/ gal FlC [51036­ 78] 0.25­ 1.0 2 2.0 (implied) 60 Use limited to Midsouth and Southeast. Application is to be directed to weeds. In Midsouth, a single application may be made at 0.25­ 0.5 lb ai/ A when soybean is at least 8 inches in height. In Midsouth and Southeast, a single application may be made at 0.5­ 1.0 lb ai/ A when soybean is at least 12 inches in height. A second application may be made. Feeding of treated forage or hay to livestock is prohibited. Application may be made alone or as a tank mix with 2,4­ DB. Minimum or no­ tillage systems Preemergence (before, during, or after planting) Ground 50% DF [1812­ 320] Coarse soils (sandy loam): 0.4­ 1.0 1 1.0 NS Application may be made alone or as a tank mix with alachlor (Lasso®), metolachlor (Dual 8E), oryzalin (Surflan), paraquat, glyphosate (Roundup®), and/ or alachlor plus glyphosate (Bronco®). Medium soils (loam, silt loam, sandy clay, sandy clay loam): 0.6­ 1.0 1 1.0 NS Fine soils (silty clay, silty clay loam, clay, clay loam): 0.7­ 1.0 1 1.0 NS Table 2 (continued). Site Application Type Application Timing Application Equipment Formulation [EPA Reg. No.] Single Application Rate, lb ai/ A Maximum Number of Applications Maximum Seasonal Application Rate, ai Preharvest Interval, days Use Limitations 1 23 1. Inappropriate tank mix recommendations are highlighted. The restricted entry interval (REI) for the 4 lb/ gal FlC (EPA Reg. Nos. 1812­ 245 and 19713­ 97) and 50% DF (EPA Reg. Nos. 1812­ 320 and 19713­ 251) formulations is 24 hours. The REI for the 4 lb/ gal FlC (EPA Reg. No. 51036­ 78) formulation is 12 hours. The labels for the 4 lb/ gal FlC (EPA Reg. Nos. 1812­ 245, 19713­ 97, and 51036­ 78) and the 50% DF (EPA Reg. Nos. 1812­ 320 and 19713­ 251) formulations include the following restrictions: application should not be made on sand, loamy sand, gravelly soils or exposed subsoils nor on soils containing less than 1% organic matter. For EPA Reg. Nos. 1812­ 245, 1812­ 320, and 19713­ 251, the following general rotational crop restrictions have been established: unless otherwise stated, any crop may be planted after 4 months except cereals where only barley, oats, rye, and wheat may be planted; West of the Rocky Mountains, carrots or celery may be planted after 4 months and no other crop may be planted within one year. Additional crop­ specific restrictions are noted in the table. EPA Reg. No. 1812­ 320 includes the following additional restriction: in the state of WA, when applications are made during the months of October, November, and December then crops can be planted 6 months after application. In addition, SLN No. WA000036 adds the following rotational crop restriction to EPA Reg. No. 18121­ 320: asparagus, barley, carrots, celery, corn (field and sweet), oats, potatoes, rye, soybeans, and wheat may be planted after 4 months except when applications are made during the months of October, November and December, for which crops may be planted 6 months after application; all other crops may be planted 12 months following application. For EPA Reg. No. 19713­ 97, the following rotational crop restrictions have been established: if initial seeding fails to produce a stand, the same crop may be replanted in soil treated preemergence with the 4 lb/ gal FlC [EPA Reg. No. 19713­ 97] formulation (or with recommended tank mixtures). Thoroughly rework soil application as injury to the crop may result. West of the Rocky Mountains, carrots or celery may be planted 4 months after last application; unless otherwise directed, no other crop may be planted within one year after the last application. For EPA Reg. No. 51036­ 78, the following rotational crop restrictions have been established: do not rotate crops used for food or feed which Wheat, winter (drill planted) Preemergence, early postemergence, or semi­ dormant Ground 4 lb/ gal FlC [1812­ 245] [19713­ 97] [51036­ 78] 0.25­ 1.75 1 1.75 (west of the Cascade Range) 0.75 (east of the Cascade range) NS Use limited to ID, OR, and WA for a single preemergence, early postemergence, or semidormant application made in the fall or winter. Application may be made alone or as a tank mix with bromoxynil. Grazing or feeding immature plants to livestock is prohibited. A 6­ month PBI for any rotational crop has been established. Table 2 (continued). 24 are not registered for use with linuron onto areas previously treated with this chemical. 2. PGI = pregrazing interval. 3. Label also states that sorghum and field corn may be planted within 4 months and that any crop may be planted after 4 months. 25 (continued) C. SUMMARY OF RESIDUE CHEMISTRY DATA REQUIREMENTS Table 3. Summary of Residue Chemistry Data Requirements for Linuron (PC Code 035506). OPPTS Guideline No. Guideline Description / Commodity §180.184 Tolerances (ppm) 1 Must Additional Data Be Submitted? MRID Nos. 2 Comments 860.1200 Directions for Use NA Yes – Several label amendments are required. 3 860.1300 Nature of the Residue ­ Plants NA No 00018173 00018176 00027624 00164195 00164196 40084801 4 41716101 5 41716102 5 41938101 6 42542101 7 42548401 8 Metabolism studies on corn, soybeans, and potatoes are adequate. 860.1300 Nature of the Residue ­ Animals NA No 00029932 42635401 9 43245101 10 Ruminant and poultry metabolism studies are adequate. 860.1340 Residue Analytical Method Plant commodities NA Yes 00018087 00018089 00018127 00018176 The registrants must propose the current GC/ ECD data collection method as an enforcement method. Animal commodities NA Yes 00018176 The registrants must propose the current GC/ ECD data collection method as an enforcement method. 860.1360 Multi­ Residue Method NA No See PAM, Vol. I, Appendix II No comment 860.1380 Storage Stability Data Plant commodities NA Yes 00159802 11 41716103 5 42836701 12 42836702 12 42913301 13 42974401 13 43040001 13 43104401 14 43215901 15 43215902 15 43288301 16 43288302 16 43356202 15 43356203 15 43681401 17 The final reports for ongoing storage stability studies on cotton gin byproducts and cotton processed commodities (up to 3 months) and sweet corn commodities (up to 6 months) must be submitted. In addition, information pertaining to sample storage intervals and conditions for samples used for tolerance reassessment must be submitted for parsnips. Table 3 (continued). OPPTS Guideline No. Guideline Description / Commodity §180.184 Tolerances (ppm) 1 Must Additional Data Be Submitted? MRID Nos. 2 Comments 26 (continued) Animal commodities NA Yes none Storage conditions and intervals for samples from the animal feeding studies must be submitted. Supporting storage stability data may be needed if samples were stored longer than one month prior to analysis. 860.1400 Magnitude of the Residue ­ Water, Fish, and Irrigated Crops NA NA NA No comment 860.1460 Magnitude of the Residue ­ Food Handling NA NA NA No comment 860.1480 Magnitude of the Residue ­ Meat, Milk, Poultry, Eggs ­ Milk, fat, meat, and meat byproducts of cattle, goat, hog, horse, and sheep 1, fat, meat, and meat byproducts No 00018209 00018210 00018375 00018450 00018775 00029932 Adequate feeding study data are available for tolerance reassessment, pending submission of storage stability information. ­ Eggs, fat, meat, and meat byproducts of poultry None No 00018383 Tolerances for poultry commodities are not required. 860.1500 Crop Field Trials Root and Tuber Vegetables Group ­ Carrot 1 No 00018172 00027635 00163267 18 40210901 19 40537601 41503401 20 Adequate field trial data are available. ­ Parsnip 0.5 No 00018171 Adequate field trial data are available. ­ Potato 1 No 00027635 00163267 18 40210901 19 41452701 20 Adequate field trial data are available. Table 3 (continued). OPPTS Guideline No. Guideline Description / Commodity §180.184 Tolerances (ppm) 1 Must Additional Data Be Submitted? MRID Nos. 2 Comments 27 (continued) Leafy Vegetables Group ­ Celery 0.5 Yes 00018443 40537601 41501501 20 43681401 17 Griffin Corporation submitted IR­ 4 residue data in support of a request for amended use of the 4 lb/ gal FlC and 50% DF formulations on celery grown west of the Rocky Mountains. HED concluded that two additional field trials in Region 10 are required to fulfill the residue data requirements. ­ Parsley 0.25 [180.184( c)] No 41189801 21 Adequate field trial data are available. Legume Vegetables Group ­ Soybean seed and aspirated grain fractions 1, seed No 00018076 00018206 00027635 00163267 18 40210901 19 43039101 22 Adequate field trial data are available for soybean seed. Residue data for soybean aspirated grain fractions are not required. Foliage of Legume Vegetables Group ­ Soybean forage and hay 1, forage 1, hay No 00018076 00018206 00027635 Provided that pertinent labels are modified to prohibit the feeding of soybean forage and hay to livestock, no data are required. Cereal Grains Group ­ Corn, field, grain and aspirated grain fractions 0.25, grain No 00018171 00018206 00018375 00018382 00018450 00163267 18 40210901 19 40537601 42948501 23 43044101 24 Adequate data are available for field corn grain. ­ Corn, pop, grain 0.25 No NA There are currently no registered uses on popcorn. Table 3 (continued). OPPTS Guideline No. Guideline Description / Commodity §180.184 Tolerances (ppm) 1 Must Additional Data Be Submitted? MRID Nos. 2 Comments 28 (continued) ­ Corn, sweet (K+ CWHR) 0.25 Yes 00018171 00018206 00018375 00018382 00018450 45444101 25 Crop field trial data from three additional trial sites must be submitted to fulfill geographic representation requirements. Because the data submitter (Griffin) has deleted uses on sweet corn from product labels, a use on sweet corn must be proposed prior to acceptance of the field trial data. ­ Sorghum, grain and aspirated grain fractions 0.25, grain No 00018171 00018148 40537601 41377601 Adequate field trial data are available for sorghum grain. Residue data for sorghum aspirated grain fractions are not required. ­ Wheat, grain and aspirated grain fractions 0.25, grain No 00018171 00018175 40537601 42605901 26 Adequate field trial data are available for wheat grain. Residue data for wheat aspirated grain fractions are not required. Forage, Fodder, and Straw of Cereal Grains Group ­ Corn, field, forage and stover 1, forage 1, fodder No 00018171 00018206 00018375 00018382 00018450 00163267 18 40210901 19 40537601 42948501 23 43044101 24 Adequate field trial data are available. ­ Corn, pop, stover 1, fodder No None There are currently no registered uses on popcorn. ­ Corn, sweet, forage and stover 1, forage 1, fodder Yes 00018171 00018206 00018375 00018382 00018450 45444101 25 Crop field trial data from three additional trial sites must be submitted to fulfill geographic representation requirements. Because the data submitter (Griffin) had deleted uses on sweet corn from product labels, a use on sweet corn must be proposed prior to acceptance of the field trial data. Table 3 (continued). OPPTS Guideline No. Guideline Description / Commodity §180.184 Tolerances (ppm) 1 Must Additional Data Be Submitted? MRID Nos. 2 Comments 29 (continued) ­ Sorghum, forage and stover 1, forage 1, fodder Yes 00018171 00018148 40537601 No data have been submitted in response to the Update. Data pertaining to residues in/ on sorghum forage and fodder following a single postemergence application of a 50% DF or 4 lb/ gal FlC formulation at the maximum registered rate remain outstanding. ­ Wheat, forage, hay, and straw 0.5, forage 0.5, hay 0.5, straw Yes 00018171 40537601 42605901 26 Adequate field trial data are available for wheat straw, which indicate that the established tolerance is too low; however these data reflect application at >1x. Field residue data remain outstanding for wheat forage and wheat hay; the registrants may also wish to generate field trial data for wheat straw. Miscellaneous Commodities ­ Asparagus 7.0 No 00018087 00018089 00163267 18 40210901 19 41452601 20 Adequate field trial data are available. ­ Cotton, seed and gin byproducts 0.25, seed Yes 00018067 41569901 20 45302201 27 Additional data and/ or information is required to fulfill geographic representation requirements. 860.1520 Processed Food/ Feed ­ Corn, field None No 42560001 28 Adequate processing data are available. ­ Cotton, seed None No 45302201 27 Adequate processing data are available. ­ Potato None Yes 40049201 29 42397201 30 Additional information pertaining to sample storage, the processing protocol, and LOQ determination, as well as an explanation for low method recoveries from potato chips, are required to upgrade the submitted potato processing study. ­ Sorghum, grain None No 42542102 7 Adequate processing data are available. Table 3 (continued). OPPTS Guideline No. Guideline Description / Commodity §180.184 Tolerances (ppm) 1 Must Additional Data Be Submitted? MRID Nos. 2 Comments 30 1. All tolerances are established under §180.184( a) unless otherwise specified. 2. Bolded references were reviewed in the 6/ 90 Update. Unbolded references were reviewed in the 6/ 82 Registration Standard. Otherwise, MRIDs were reviewed as noted. 3. A review of the above EP labels and the supporting residue data indicate that the following label amendments are required: ° The product labels include directions for use for a number of tank mixes. In many cases, the tank mix products are no longer registered for use on the subject crop. The following tank mix recommendations must be removed from all relevant product labels: chloramben ­ Soybean None No 00018206 41241202 31 42462901 32 Adequate processing data are available. ­ Wheat None No The requirement for a wheat processing study has been waived. 860.1560 Reduction of Residues NA Yes 41241201 31 42397201 30 42379901 33 Additional information on sample storage, the cooking protocol, and the determination of LOQs is required to upgrade the potato cooking study. Additional information on the determination of limits of quantitation and an adequate description of the cooking procedure are required to upgrade the carrot cooking study. 860.1850 Confined Accumulation in Rotational Crops NA No 40104101 40730101 An adequate confined rotational crop study is available. 860.1900 Field Accumulation in Rotational Crops None Yes None The requirements for field rotational crop studies have been waived based on the results of the confined rotational crop study. The registrants must modify all rotational crop restrictions such that specific plantback intervals are defined (e. g., "do not plant any crop within 4 months of application to treated sorghum"). In addition, the registrants must provide justification for any plantback intervals on the product labels. Table 3 (continued). 31 on any crop (no currently registered chloramben products); dinoseb on any crop (no currently registered dinoseb products); oryzalin on soybeans; and propachlor on soybeans. Also, the product labels for the 50% DF formulations (1812­ 320 and 19713­ 251) include tank mix recommendations for Bronco®, a product which was cancelled 3/ 9/ 00. Inappropriate tank mix recommendations are highlighted in Table 2. ° The following grazing/ feeding restriction are considered to be impractical by HED and must be removed from the appropriate product labels: restrictions against the grazing or feeding of treated sorghum forage or silage to dairy animals (EPA Reg. Nos. 1812­ 320, 19713­ 97, 19713­ 251, and 51036­ 78); restrictions against the feeding of cotton gin trash to livestock (EPA Reg. Nos. 1812­ 245, 19713­ 251, and 51036­ 78 as well as SLN Nos. AL000002, AR0000007, AR000008, LA000013, LA000015, MS000001, MS000011, TN000005, TN000006, and TX000012); and restrictions against the grazing/ feeding of immature wheat plants to livestock (EPA Reg. Nos. 1812­ 245, 19713­ 97, and 51036­ 78). ° The following crops/ use directions require preharvest intervals (PHIs) to be specified: postemergence uses on sorghum (EPA Reg. Nos. 1812­ 245, 1812­ 320, 19713­ 97, 19713­ 251, and 51036­ 78); application to newly planted or direct­ seeded asparagus (EPA Reg. Nos. 1812­ 245, 1812­ 320, 19713­ 97, 19713­ 251 and SLN No. ID970004); postemergence application to carrots grown in NY (EPA Reg. Nos. 1812­ 245 and 1812­ 320); postemergence application to field corn (EPA Reg. Nos. 1812­ 245, 19713­ 97, 19713­ 251, and 51036­ 78); posttransplant application to celery (EPA Reg. No. 1812­ 245, 1812­ 320, 19713­ 97, 19713­ 251, and 51036­ 78); and postemergence application to cotton (EPA Reg. Nos. 1812­ 245, 19713­ 251, and 51036­ 78 as well as SLN Nos. AL000002, AR0000007, AR000008, LA000013, LA000015, MS000001, MS000011, TN000005, TN000006, and TX000012). ° Products labels which contain use directions for asparagus must be modified to make it clear that the maximum combined application rate is 4.0 lb ai/ A/ season when more than one type of application (preemergence, postemergence, or application at the fern stage) is made. In addition, the available crop field trial data for asparagus are sufficient to support application of linuron to asparagus in all areas of the U. S. Therefore, the registrants may wish to modify product labels to remove the restrictions limiting use on asparagus to certain states. ° The product label for EPA Reg. No. 1812­ 245 includes two tables of application rates at the end of the soybean use directions which are titled "Soybeans: Broadcast Application ­ Linex 4L and Sencor DF and Lasso" and "Soybeans: Broadcast Application ­ Linex 4L and Sencor DF and Duel 8E." The label should be modified to clarify application timing for these tables; it is not clear to which application type (preemergence or postemergence) these application rates pertain. 4. CBRS No. 2838, 12/ 24/ 87, L. Propst. 5. DP Barcode D160079, 4/ 25/ 91, R. Perfetti. 6. DP Barcode D167107, 5/ 21/ 92, P. Deschamp. 7. DP Barcode D187993, 11/ 18/ 93, D. McNeilly. 8. DP Barcode D187998, 11/ 18/ 93, D. McNeilly. Table 3 (continued). 32 9. DP Barcode D188002, 11/ 18/ 93, D. McNeilly. 10. DP Barcode D204807, 7/ 27/ 94, D. Miller. 11. CBRS No. 1244, 8/ 12/ 85, J. Garbus. 12. DP Barcode D195090, 10/ 5/ 93, D. McNeilly. 13. DP Barcode D198861, 3/ 29/ 94, D. McNeilly. 14. DP Barcode D199375, 3/ 16/ 94, D. McNeilly. 15. DP Barcodes D203624 and D207488, 1/ 11/ 95, S. Hummel. 16. DP Barcode D206666, 9/ 23/ 94, D. Miller. 17. DP Barcodes D216614 and D216621, 10/ 13/ 95, W. Cutchin. 18. CB No. 1317, 10/ 29/ 86, J. Garbus. 19. CB No. 2333, 6/ 2/ 87, J. Garbus. 20. CB Nos. 6663 and 6994, 3/ 26/ 91, R. Perfetti. 21. CB No. 5658, 10/ 5/ 89, F. Griffith. 22. DP Barcode D198859, 3/ 16/ 94, D. McNeilly. 23. DP Barcode D196857, 12/ 15/ 93, D. McNeilly. 24. DP Barcode D198851, 3/ 31/ 94, D. McNeilly. 25. DP Barcode D276294, 9/ 21/ 01, J. Punzi. 26. DP Barcode D188028, 5/ 10/ 93, D. McNeilly. 27. DP Barcode D271950, 9/ 24/ 01, J. Punzi. 28. DP Barcode D188001, 7/ 13/ 93, D. McNeilly. 29. CBRS No. 2279, 6/ 2/ 87, J. Garbus. 30. DP Barcode D181454, 9/ 2/ 92, S. Knizner. 31. CBRS No. 5858, 10/ 31/ 89, C. Olinger. 32. DP Barcode D182595, 3/ 18/ 93, D. McNeilly. 33. DP Barcode D181455, 9/ 8/ 92, S. Knizner. 33 D. RESIDUE CHARACTERIZATION General Discussion on Residue Chemistry of Linuron 1. Nature of the Residue in Plants The qualitative nature of the residue in plants is adequately understood (D. McNeilly, 11/ 17/ 93). Metabolism studies with corn, soybeans, and potatoes indicate that linuron is absorbed from the soil and translocated (i. e., systemic). The metabolic pathway involves demethylation to 3­( 3,4­ dichlorophenyl)­ 1­ methoxyurea (desmethyl linuron) which is further metabolized to 3,4­ dichloroaniline (3,4­ DCA); metabolism may also occur through demethoxylation of linuron. The residues of concern in plants are linuron and its metabolites convertible to 3,4­ DCA; the chemical structures of linuron and its metabolites identified in plant and animal metabolism studies are presented in Figure 1. Corn (MRID 40084801): Corn samples (forage, fodder, silage, and dry ear corn) were harvested 0­ 116 days following a single over­ the­ top application of uniformly ring­ labeled [phenyl­ 14 C] linuron at 1.4 lb ai/ A (-1x the maximum registered postemergence application rate) when corn plants were 15­ 18 inches tall. The TRR, expressed as [ 14 C] linuron equivalents, were: (i) 66.10 ppm in corn forage harvested 0 days posttreatment and 2.05 ppm in corn forage harvested 31 days posttreatment; (ii) 0.34­ 0.37 ppm in silage harvested 89 days posttreatment; and (iii) 0.01­ 0.014 ppm in corn grain, 0.844­ 1.09 ppm in corn fodder, and 0.049­ 0.31 ppm in cobs & husks harvested 98­ 116 days posttreatment. The parent linuron was found at 7.5­ 91.7% of TRR (0.15­ 60.6 ppm) in forage, 4.8% of TRR (0.016 ppm) in silage, 4.7% of TRR (0.051 ppm) in fodder, and 5.2% of TRR (0.002 ppm) in cobs & husks. Other residues identified in corn matrices were desmethyl linuron at 0.5­ 10.9% of TRR (0.001­ 0.80 ppm), desmethoxy linuron at <1­ 3.5% TRR (< 0.001­ 0.76 ppm), DCPU at 0.5­ 6.9% of TRR (0.002­ 0.30 ppm), and 3,4­ DCA at <0.05­< 1% of TRR (< 0.001­< 0.04 ppm). Polar unknowns accounting for 0.8­ 40.0% of TRR (0.089­ 1.82 ppm) in forage, silage, fodder, and cobs & husks were observed. Additional studies were conducted in order to generate more samples for isolation of larger amounts of polar metabolites for characterization. Based on the analysis of samples using the enforcement analytical method, it was concluded that unidentified polar components in plants are hydrolyzed to 3,4­ DCA. Potato (MRID 42542101): Immature potato plant samples were harvested 24, 31, 51, 72, and 111 days, and mature potato plants were harvested 115 days following a single preemergence (after planting) application of uniformly ring­ labeled [phenyl­ 14 C] linuron at 2.0 lb ai/ A (1x the maximum registered seasonal application rate). Plants harvested <72 days after treatment were analyzed as whole plants, and plants harvested at 72, 77, 111, and 115 days after treatment were separated into foliage and tubers for analysis. The TRR, expressed as [ 14 C] linuron equivalents, were: (i) 0.24­ 0.34 ppm in whole plants harvested 24­ 51 days posttreatment; (ii) 0.22­ 0.26 ppm in foliage and 0.01­ 0.02 ppm in tubers harvested 72­ 111 days posttreatment; (iii) 0.67 ppm in foliage, 0.03 ppm in unpeeled 34 tubers, 0.02 ppm in peeled tubers, and 0.09 ppm in peelings harvested (at maturity) 115 days posttreatment. The parent linuron was found at 30.7­ 56.7% of TRR (0.14­ 0.21 ppm) in potato foliage at 24­ 115 days postreatment. Other residues identified in potato foliage were desmethyl linuron at 1.7­ 4.7% of TRR (< 0.01­ 0.02 ppm; 24­ and 31­ day posttreatment samples only), desmethoxy linuron at 5.8­ 13.1% (0.02­ 0.09 ppm), and norlinuron (DCPU) at 1.9­ 8.1% TRR (< 0.01­ 0.05 ppm). Polar unknowns accounting for 2.4­ 33.2% of TRR (< 0.01­ 0.11 ppm) in potato foliage were observed. Even though the specific identity of the polar metabolites was unknown, enforcement method analyses indicated that they were all converted to 3,4­ DCA under the alkaline conditions of the enforcement method. Soybean (MRID 42548401: Mature soybean plants were harvested 87 days following a single postemergence directed spray application (to the lower three inches of the soybean stem) of uniformly ring­ labeled [phenyl­ 14 C] linuron at 1.0 lb ai/ A (1x the maximum registered postemergence application rate). The TRR, expressed as [ 14 C] linuron equivalents, were 75.2% of TRR (3.76 ppm) in foliage, 16.2% of TRR (0.81 ppm) in pods, and 8.6% of TRR (0.43 ppm) in soybeans harvested (at maturity) 87 days posttreatment. The parent linuron was found at 3.4% of TRR (0.2 ppm) in soybean foliage, 1.0% of TRR (< 0.01 ppm) in soybean pods, and was nondetectable in soybeans. Other residues identified were: (i) desmethyl linuron at 0.3% of TRR (0.02 ppm), desmethoxy linuron at 6.1% of TRR( 0.26 ppm), and norlinuron at 12.6% of TRR (0.54 ppm) in soybean foliage; (ii) desmethoxy linuron at 5.7% of TRR (0.05 ppm) and norlinuron at 11.1% of TRR (0.10 ppm) in soybean pods; and (iii) desmethoxy linuron at 31.3% of TRR (0.1 ppm) and norlinuron at 8.4% of TRR (0.04 ppm) in soybeans. Polar unknowns accounting for 57.2% of TRR (2.48 ppm) in soybean foliage, 52.6% of TRR (0.47 ppm) in soybean pods, and 49.2% of TRR (0.22 ppm) in soybeans were also observed. Even though the specific identity of the polar metabolites was unknown, the metabolites appeared to be quantitatively converted to 3,4­ DCA under the alkaline conditions of the enforcement method. 35 N H Cl Cl O N O CH 3 CH 3 N H N H O Cl Cl CH 3 N H NH 2 O Cl Cl N H Cl Cl O N H O CH 3 N H Cl Cl O NH 2 OH NH 2 Cl Cl Figure 1. Chemical names and structures of linuron and its metabolites identified in plant and animal commodities. Linuron: 3­( 3,4­ dichlorophenyl)­ 1­ methoxy­ 1­ methylurea DCPMU; IN­ 15654; Desmethoxy linuron: 3­( 3,4­ dichlorophenyl)­ 1­ methylurea DCPU; Norlinuron; IN­ R915: 3,4­ dichlorophenylurea Desmethyl linuron: 3­( 3,4­ dichlorophenyl)­ 1­ methoxyurea Hydroxy­ norlinuron: (4,5­ dichloro­ 2­ hydroxyphenyl) urea 3,4­ DCA: 3,4­ dichloroaniline 2. Nature of the Residue in Livestock The qualitative nature of the residue in ruminants and poultry is adequately understood (D. McNeilly, 11/ 17/ 93). An acceptable metabolism study with goats indicates that linuron is rapidly metabolized by demethylation, demethoxylation, and hydroxylation and is primarily eliminated by excretion. The metabolism of linuron in poultry has been found to be consistent with metabolism in goats. The terminal residues of concern are the parent and its metabolites which are convertible to 3,4­ DCA. Ruminants (MRID 00029932): Lactating goats were dosed with uniformly ring­ labeled 14 C] linuron at 1 and 5 ppm (0.14x and 0.7x, respectively, the maximum dietary burden of 7.22 ppm for dairy cattle) for 5 consecutive days. During the feeding period, ~85­ 86% of the radioactivity was rapidly eliminated from the body. The TRR in milk, expressed as linuron equivalents, were 0.004­ 0.005 ppm for the 1­ ppm dose group and 0.014­ 0.027 ppm from the 5­ ppm dose group. For the 1­ ppm dose group, TRR were 0.070 ppm in liver, 0.029 ppm, in kidney, and 0.001 ppm in muscle and fat. For the 5­ ppm dose group, TRR were 0.358 ppm in liver, 0.150 ppm in kidney, 0.015 ppm in fat, and 0.014 ppm in muscle. No intact linuron (< 0.001 ppm) was detected in the milk, tissues, or urine of the test animals. About 95% of the radioactivity in milk was identified as polar metabolites based on polar solvents used in TLC procedure. No attempts were made to identify these polar metabolites in the study. Poultry (MRIDs 42635401 and 43245101): Laying hens were dosed with uniformly ring­ labeled [phenyl­ 14 C] linuron at 10 ppm (~ 45x the maximum dietary burden of 0.22 ppm) for 5 consecutive 36 days. At sacrifice, the highest levels of radioactivity in poultry tissues and eggs were observed in liver (0.57­ 1.13 ppm; mean of 0.78 ppm) and kidney (0.44­ 0.75 ppm; mean of 0.60 ppm). Residues were 0.1­ 0.17 ppm (mean of 0.13 ppm) in fat and 0.05­ 0.12 ppm in muscle (mean of 0.09 ppm for thigh muscle and 0.07 ppm for breast muscle), while residues in whole eggs ranged from 0.02 ppm (Day 1) to 0.12 ppm (Day 5). Linuron was observed only in egg yolk and fat as a minor component of the residue profile (< 1.3­ 2.8% TRR, <0.01­ 0.01 ppm). Norlinuron was the primary metabolite found in poultry tissues and eggs which comprised 65­ 68.5% of TRR (0.05 ppm) in muscle, 40.8% of TRR (0.04 ppm) in fat, 65.2% of TRR (0.38 ppm) in liver, 41.6% of TRR (0.17 ppm) in kidney, 51.9­ 64.7% of TRR (0.01­ 0.19 ppm) in egg yolk and 12.0­ 15.5% of TRR (< 0.01 ppm) in egg white. Desmethyl linuron, DCPMU, and hydroxy­ norlinuron were also detected at low levels (#0.05 ppm). 3,4­ DCA was detected at very low levels in poultry tissues; <0.01 ppm for kidney, muscle, fat, egg white, and egg yolk and 0.01 ppm in liver. The HED Metabolism Committee concluded (D. McNeilly, 11/ 17/ 93) that linuron can be regulated using the enforcement method. Residues of concern are linuron and metabolites convertible to 3,4­ DCA, expressed as linuron. 3,4­ DCA, per se, need not be regulated separately. 3. Residue Analytical Methods The reregistration requirements for residue analytical methods are not fulfilled. The registrants must propose the current data collection method, a GC/ ECD method, as an enforcement method for plant and animal commodities to replace the current colorimetric enforcement method, which is outdated. The Pesticide Analytical Manual (PAM) Vol. II lists a colorimetric method (Method I, Bleidner et al.) and a paper chromatographic method (Method II) for the enforcement of tolerances for linuron residues. Residues of diuron may interfere in Method I. A modified version of Method I (H. L. Pease, Journal of Agric. and Food Chem., 1962, Vol. 10, p. 279), which includes a cellulose column step to separate linuron from diuron, has been used for tolerance enforcement purposes. Both these methods determine linuron and all metabolites hydrolyzable to 3,4­ DCA and have limits of detection of 0.05 ppm. A GLC/ ECD method for linuron residues in/ on asparagus from the CA Department of Food and Agriculture has been validated by the Agency and sent to FDA to be published in PAM Vol. II as Method III. This method determines residues of linuron per se and the limit of detection is 0.05 ppm. We note however that this method is inadequate for tolerance enforcement since it does not determine all the residues of concern. In addition, this method uses benzene as the extraction solvent. Residue data for linuron for plant and animal commodities were collected using Method I (or modifications thereof) or a GC/ ECD method similar to Method I. The GC/ ECD data collection method involves conversion of residues to 3,4­ DCA and therefore will detect residues of linuron and its metabolites, or any compound that can be hydrolyzed to 3,4­ DCA (such as diuron). The method involves hydrolysis of samples by alkaline reflux to convert residues to 3,4­ DCA, distillation into concentrated acid, neutralization, and clean up by silica gel column 37 chromatography. The eluates are then analyzed by GC/ ECD. The LOQ is 0.01 ppm. We note that this method is the same method used for data collection purposes for residues of diuron in/ on plant and animal commodities. As discussed above, samples from the plant and animal metabolism studies were analyzed using the extraction procedures of the enforcement methods, which demonstrated that the identified metabolites plus a large portion of the unidentified polar metabolites were converted to 3,4­ DCA and would therefore be determined using the enforcement method. 4. Multiresidue Method Testing The FDA PESTDATA database dated 10/ 99 (PAM Vol. I, Appendix II) contains data concerning the applicability of multiresidue methods D and E (fatty and nonfatty foods) for recovery of linuron and its metabolites desmethyl linuron, DCPMU, DCPU, and 3,4­ DCA. Linuron recovery using Multiresidue Methods Sections 302 (Luke Method; Protocol D), 303 (Mills, Onley, and Gaither; Protocol E, nonfatty), and 304 (Mills, fatty food) is variable (but $40%). There is a small recovery (< 50%) of 3,4­ DCA using Section 303, and variable recovery using Section 302; no data are available for Section 304. Linuron metabolites desmethyl linuron, DCPMU, and DCPU are not recovered using Sections 303 and 304. Linuron metabolite desmethyl linuron is recovered using Section 302, but no quantitative information is available. No recovery data are available for Section 302 for linuron metabolites DCPMU and DCPU. 5. Storage Stability Data The reregistration requirements for storage stability are not fulfilled. The final reports for ongoing storage stability studies on cotton gin byproducts, cotton processed commodities (up to 3 months), and sweet corn commodities (up to 6 months) must be submitted. In addition, information pertaining to sample storage intervals and conditions for samples used for tolerance reassessment must be submitted. This information is needed for parsnips (field trial data in MRID 00018171) and for the animal feeding studies (MRIDs 00018209, 00018210, 00018375, 00018383, 00018450, and 00018775). The available storage stability data indicate that linuron residues of concern are stable during frozen storage at ­20 C in asparagus (fresh and cooked) for at least 24 months, carrots (fresh and cooked) for at least 21 months, potatoes for at least 18 months, celery for at least 18 months, corn grain for at least 12 months, sorghum grain for at least 12 months, corn oil for at least 12 months, sorghum starch for at least 12 months, potato wet peel for at least 18 months, potato dry peel for at least 18 months, mashed potatoes for at least 18 months, potato chips for at least 20 months, dehydrated potato granules for at least 20 months, soybean oil for at least 18 months, and soybean tofu for at least 18 months. 38 The available storage stability data will support field trial data on leafy vegetables, oilseeds/ nuts, and root crops stored for 2 years at ­18 C and on grain crops stored for 1 year at ­18 C. Available storage stability data on processed commodities will support processing studies on grains, oilseeds, and root crops where samples were stored at ­18 C up to 12 months and 18 months for soybean oil and tofu studies, and 18­ 20 months for potato processed commodities. HED concludes that additional storage stability data (beyond those already promised to HED) will not be necessary provided that storage intervals do not exceed one year for non­ oily grains and two years for oilseeds/ nuts, leafy vegetables, and root crops: the registrant has provided sufficient data to indicate that significant linuron residue declines are not expected to occur in oilseeds/ nuts, leafy vegetables, root vegetables, and non­ oily grains over short to intermediate storage intervals. Since residues have been shown to be stable in several matrices of several different crop groupings, no additional storage data other than studies currently in progress discussed above will be required, provided that linuron is not registered for use on fruits, fruiting vegetables, or citrus. Storage stability data for soybean seeds and sugar beet tops were submitted previously (MRID 00159802). Additional raw data were required to support these data before HED could conclude that the data were adequate (CB No. 1244, 8/ 12/ 85, J. Garbus); these data have not been submitted. Although not supported by raw data, the study indicated that residues of linuron were stable during up to two years of frozen storage in/ on soybeans and sugar beet tops. We note that the available storage stability studies reflect fortification of samples with linuron per se; storage stability data for the metabolites were not submitted. Because the methods used for analysis were the methods which convert residues to 3,4­ DCA and because any degradation product of linuron or its metabolites would likely be a compound hydrolyzable to 3,4­ DCA, HED concludes that storage stability data for linuron metabolites will not be required. There is no indication in HED files that storage stability data for livestock commodities have been submitted. As stated above, information pertaining to the storage conditions and intervals of samples used for tolerance reassessment must be submitted. If samples from the animal feeding studies were stored for longer than one month prior to analysis, supporting storage stability data will be required. 6. Magnitude of the Residue in Crop Plants The reregistration requirements for magnitude of the residue in plants are fulfilled for asparagus, carrots; field corn grain; field corn forage and fodder; cottonseed; parsley; parsnips; potatoes; sorghum grain; sorghum aspirated grain fractions; soybeans; soybean forage and hay; soybean aspirated grain fractions; and wheat grain. Adequate field trial data depicting linuron residues of concern following applications made according to the maximum registered use patterns have been submitted for these commodities. Geographical representation is adequate, and a sufficient number of trials reflecting representative formulation classes were conducted. 39 The reregistration requirements for magnitude of the residue in plants are not fulfilled for: celery; corn, field, aspirated grain fractions; corn, sweet (K+ CWHR); corn, sweet, forage; corn, sweet, stover; cotton gin byproducts; sorghum forage and stover; wheat forage, hay, and straw. Additional crop field trial data and/ or information is required for these commodities. Brief summaries of available linuron residue data, useful for tolerance reassessment only, along with the status of requirements for RACs eligible for reregistration, are presented below. Root and Tuber Vegetables Group Carrot: The 2/ 94 RED concluded that Griffin and Drexel must submit additional residue data for carrots. However, the 2/ 95 RED Addendum concluded that, provided label amendments are made to reflect a 14­ day PHI, no additional field trial data would be required for carrots. Data reported in MRID 41503401 indicate that the linuron residues of concern will not exceed the established tolerance of 1.0 ppm in/ on carrots harvested 14 days following a preemergence application at 0.5 lb ai/ A plus a postemergence application at 1­ 1.5 lb ai/ A using a 50% DF or 4 lb/ gal FlC formulation. Tests conducted in FL and NJ received a total of 1.5 lb ai/ A (0.75x the maximum seasonal rate), and tests conducted in CA and WI each received a total of 2.0 lb ai/ A (1x the maximum seasonal rate). Linuron residues of concern were 0.08­ 0.45 ppm in/ on six samples treated at 1x and 0.37­ 0.56 ppm in/ on four samples treated at 0.75x. Samples were stored frozen for 368­ 648 days prior to analysis, which is within the 2­ year interval that linuron residues have been shown to be stable in root crops. Data from additional carrot field trials (MRID 40537601) indicate that residues ranged from 0.28­ 0.50 ppm and 0.30­ 0.60 ppm in/ on samples of washed and unwashed carrots, respectively, harvested 14 days following either a single postemergence application of a 50% WP or 50% DF formulation at 2.0 lb ai/ A (1x the maximum seasonal application rate) or two applications for a total rate of 2.0 or 4.0 lb ai/ A (1x or 2x the maximum seasonal application rate). Samples were stored frozen for 125­ 127 days prior to analysis. Currently, the Griffin labels (EPA Reg. Nos. 1812­ 245 and 1812­ 320) for the 4 lb/ gal FlC and 50% DF formulations do not specify a PHI for postemergence application to carrots in NY. The registrant must modify the product labels to reflect a 14­ day PHI for carrots. Parsnip: No additional residue data for parsnips are required. Previously, data had been required comparing the use of a DF formulation with that of an FlC formulation on parsnips. These requirements have been waived, based on residue data for field trials conducted on asparagus, carrots, celery, corn, cotton, potatoes, sorghum, soybeans, and wheat, which indicated similar residue patterns regardless of formulation. Data reviewed in the 6/ 82 Reregistration Standard (MRID 00018171) indicate that the linuron residues of concern will not exceed the established tolerance of 0.5 ppm in/ on parsnips harvested 155, 169, and 182 days following a single application of the 50% WP at 1.0 or 2.0 lb ai/ A (0.7x or 1.3x the maximum seasonal rate). Linuron residues of concern were nondetectable (< 0.05 ppm). There is no 40 storage stability information available for these samples; these data are required (see Storage Stability Data). Potato: The 2/ 94 RED and the 2/ 95 RED Addendum concluded that no additional field trial data are required for potato. Data reported in MRID 41452701 indicate that the linuron residues of concern will not exceed the established tolerance of 1.0 ppm in/ on potatoes harvested 42­ 110 days following a single preemergence application of the 4 lb/ gal FlC formulation at 2.0 lb ai/ A (1x the maximum seasonal rate). Linuron residues of concern were nondetectable (< 0.01 ppm) in/ on five samples of potato tubers. Samples were stored frozen for 279­ 593 days, which is within the 2­ year interval that linuron residues have been shown to be stable in root crops. Data from additional potato field trials (MRID 00163267) indicate that residues were nondetectable (< 0.05 ppm) in/ on all but one sample (0.07 ppm) of potato harvested 125 to 155 days after planting. A single preeemergence or postemergence application of the WP or DF formulation was made at 1.0­ 4.0 lb ai/ A (0.5­ 2x the maximum seasonal application rate) using ground equipment. No additional field trial data are required for potatoes. Leafy Vegetables Group Celery: The 2/ 94 RED and the 2/ 95 RED Addendum concluded that no additional field trial data are required for celery grown east of the Rocky Mountains. This conclusion was based on field residue data (MRID 41501501) indicating that linuron residues of concern were 0.04­ 0.42 ppm in/ on six celery samples harvested 68­ 102 days following a single posttransplant application of the 4 lb/ gal FlC or 50% DF formulation at 1.5 lb ai/ A (1x the maximum seasonal rate) in tests performed in FL, MI, and NY (east of the Rocky Mountains). Data from additional celery field trials (MRID 40537601) indicate that linuron residues of concern were nondetectable (< 0.05 ppm) to 0.32 ppm in/ on celery (washed/ unwashed and trimmed /untrimmed) harvested 44­ 82 days following postemergence application of either the 4 lb/ gal FlC, 50% WP, or 50% DF formulation at (i) 0.5­ 1.5 lb ai/ A (0.33­ 1x the maximum single application rate) and (ii) two or four applications at consecutive intervals of 22, 13, and 19 days for a total seasonal rate of 1.5 or 3.0 lb ai/ A (1 or 2x the maximum registered seasonal rate) in tests performed in CA, FL, and MI. Samples were stored frozen for 74­ 343 days prior to analysis, which is within the 2­ year interval that linuron residues have been shown to be stable in leafy vegetable crops. Currently, the Griffin labels for the 4 lb/ gal FlC and 50% DF (EPA Reg. Nos. 1812­ 245 and 1812­ 320) formulation permit use on celery in all states including CA. Griffin Corporation submitted Interregional Research Project No. 4 (IR­ 4) residue data (MRID 43681401) in support of a request for amended use of the 4 lb/ gal FlC and 50% DF formulations (EPA Reg. Nos. 1812­ 245 and 1812­ 320) on celery grown west of the Rocky Mountains. Linuron residues of concern were 0.04­ 0.12 ppm in/ on celery grown in CA or OR and harvested 66 or 77 days following posttransplant application at 1.5 lb ai/ A (1x the maximum seasonal rate for all states except CA; 1.5x the maximum seasonal rate 41 for CA). Samples were stored frozen for up to 390 days prior to analysis. HED concluded that the geographic representation of the submitted studies was not adequate to represent the celery growing regions requested by the amended use petition; two additional field trials in Region 10 are required to fulfill the residue data requirements for celery grown west of the Rocky Mountains. HED concluded that the data were not sufficient to support the request to add uses west of the Rockies, however it was concluded that a conditional registration would be recommended while the data were generated. Parsley: The 2/ 94 RED and the 2/ 95 RED Addendum concluded that no additional field trial data are required for the regional registration for parsley grown in all states east of the Mississippi River. Data reported in MRID 41189801 indicate that the linuron residues of concern will not exceed the established tolerance of 0.25 ppm in/ on parsley grown in OH or NJ and harvested: (i) 52­ 90 days following a single preemergence application of the 4 lb/ gal FlC formulation at either 1.5 lb ai/ A (1x the maximum seasonal rate) or 3.0 lb ai/ A (2x the maximum seasonal rate) and (ii) 24 days following a preemergence application at 1.5 lb ai/ A plus a postemergence application at 0.5 lb ai/ A (1.3x the maximum seasonal application rate). Linuron residues of concern from the single preemergence application at 1x were <0.06­ 0.11 ppm in/ on 14 samples of parsley. Linuron residues of concern from the single preemergence application at 2x were 0.14­ 0.21 ppm in/ on four samples of parsley. Linuron residues of concern from the single preemergence plus postemergence application at 1.3x were 0.09­ 0.18 ppm in/ on parsley. Storage stability information for these studies was not discussed in the study review. Legume Vegetables Group Soybean seed and aspirated grain fractions: The 2/ 94 RED concluded that Griffin and Drexel must submit additional residue data for soybean because Craven data were submitted to support reregistration of linuron on soybeans. Craven replacement data reflecting postemergence application of the 50% DF or 4 lb/ gal FlC formulation at the maximum registered rate were submitted and deemed acceptable (DP Barcode D198859, 3/ 16/ 94, D. McNeilly). The 2/ 95 RED Addendum concluded that no additional soybean data were required. Data reported in MRID 43039101 indicate that the linuron residues of concern will not exceed the established tolerance of 1 ppm in/ on soybeans harvested 56­ 77 days following either (i) a single preemergence application of the DF formulation at 2.5 lb ai/ A followed by a single directed postemergence application at 1.0 lb ai/ A for a total rate of 3.5 lb ai/ A (-1x the maximum seasonal rate) or (ii) a single preemergence application of the DF formulation at 2.5 lb ai/ A (0.8x the maximum seasonal rate). Linuron residues of concern from the single preemergence plus single directed postemergence application at -1x were <0.01­ 1.0 ppm in/ on 15 samples of soybeans. Linuron residues of concern from the single preemergence application at 0.8x were <0.01­ 0.18 ppm in/ on 17 samples of soybeans. Samples were stored frozen up to 8.5 months prior to analysis, which is within the 2­ year interval that linuron residues have been shown to be stable in oilseeds. 42 There are no data available for soybean aspirated grain fractions. Because processing data for soybeans indicated no concentration of residues of concern in light impurities, data for soybean aspirated grain fractions will not be required. Foliage of Legume Vegetables Group Soybean forage and hay: The 2/ 94 RED concluded that because restrictions against the feeding of treated soybean forage and hay existed on all pertinent product labels, no data would be required for soybean forage and hay, and that the established tolerances for soybean forage and hay should be revoked. However, the 2/ 95 RED Addendum concluded that these restrictions were no longer considered practical and required tolerances and supporting residue data. The Agency has since amended its policy on label restrictions on feeding of soybean forage and hay and now allows these label restrictions on soybean forage and hay. Residue data and tolerances for soybean forage and hay will not be required, provided all pertinent labels are amended to include the following feeding restriction on the product labels: "The feeding of treated forage or hay to livestock is prohibited." Cereal Grain Group Barley, oats, and rye grain: There are no longer registered uses of linuron on barley, oats, and rye. Applicable tolerances have been revoked since the 2/ 95 RED Addendum. Corn, field, grain and aspirated grain fractions: The 2/ 94 RED concluded that Griffin and Drexel must submit additional residue data for corn because Craven data were submitted to support reregistration of linuron on field corn. Craven replacement data (MRID 42948501) reflecting two different treatments, differing only in the timing of postemergence application were submitted and deemed acceptable (DP Barcode D198851, 3/ 28/ 94, D. McNeilly). The 2/ 95 RED Addendum concluded that no additional field corn grain data were required, but that field corn aspirated grain fractions data were required. Data indicate that the linuron residues of concern will not exceed the established tolerance of 0.25 ppm in/ on field corn grain harvested 57­ 65 days following a single preemergence application of the DF formulation at 1.5 lb ai/ A followed by a single postemergence application at 1.5 lb ai/ A for a total rate of 3.0 lb ai/ A (1x the maximum seasonal rate). Linuron residues of concern from the single preemergence plus single directed postemergence application were <0.01­ 0.018 ppm in/ on nine samples of field corn grain. Storage stability information for these samples was not discussed in the study review. Data from an additional field corn grain field trial (MRID 40537601) indicate that linuron residues were nondetectable (< 0.05 ppm) to 0.06 ppm in/ on two samples of field corn grain harvested 98 and 116 days following a single postemergence application of the 4 lb/ gal FlC formulation at 1.5 lb ai/ A (1x the maximum postemergence application rate). Samples were stored frozen for up to 110 days prior to analysis, which is within the 1­ year interval that linuron residues have been shown to be stable in grain crops. 43 Data from an additional field corn grain field trial (MRID 00163267) indicate that linuron residues were nondetectable (< 0.05 ppm) in/ on 31 samples of field corn grain harvested 128­ 150 days after planting following a single preemergence application of the DF formulation at 0.5­ 1.5 lb ai/ A (0.3­ 1x the maximum preemergence application rate). Storage stability information for these samples was submitted but was not discussed in the study review. Corn field trial data (MRIDs 00018171, 00018206, 00018375, 00018382, and 00018450) reviewed in the 6/ 82 Reregistration Standard indicate that linuron residues were: (i) nondetectable (< 0.05 ppm) in/ on corn grain harvested 56­ 65 days following a single postemergence application of the WP formulation at 0.75­ 6.0 lb ai/ A; and (ii) nondetectable (< 0.05 ppm) in/ on corn grain harvested 116­ 125 days following a single preemergence application of the WP formulation at 1.5 lb ai/ A. Note: No distinction was made in the Science Chapter about the type of corn (field or sweet) that was treated. No storage stability information is available for these samples. There are no data available for field corn aspirated grain fractions. This data requirement cannot be waived because the corn grain processing study indicated concentration of linuron residues of concern in light impurities. Aspirated grain fractions data remain outstanding. Corn, pop, grain: There are no registered uses of linuron on popcorn. The applicable tolerance for popcorn should be revoked. Corn, sweet (K+ CWHR): Additional data were required for sweet corn (K+ CWHR) in the 6/ 90 Update. The 2/ 94 RED and the 2/ 95 RED Addendum reiterated this data requirement. Crop field trial data for sweet corn were submitted by Griffin; these data are inadequate to fulfill reregistration requirements because of incomplete geographic representation. An additional three crop field trials must be conducted in Regions 1 (1 trial) and 5 (2 trials). In addition, because Griffin had deleted uses on sweet corn from product labels, a use on sweet corn must be proposed. Although inadequate, the field trial data indicate that linuron residues of concern were below the LOQ (< 0.01 ppm) to 0.048 ppm in/ on sweet corn K+ CWHR harvested at maturity following a single soil directed application of the 50% DF or 4 lb/ gal FlC formulation at 1.48­ 1.57 lb ai/ A made when sweet corn plants were at least 15 inches tall. Samples were stored frozen for up to 6 months prior to analysis; a supporting storage stability study is ongoing. Sorghum, grain and aspirated grain fractions: The 2/ 94 RED and the 2/ 95 RED Addendum concluded that no additional field trial data are required for sorghum grain. Data reported in MRID 40537601 indicate that the linuron residues of concern were nondetectable (< 0.05 ppm) in/ on six samples of sorghum grain harvested 137­ 154 days following a single preplant application of the 50% DF at 0.5­ 0.63 lb ai/ A (0.3­ 0.4x the maximum preemergence application rate). Data reported in MRID 41377601 indicate that the linuron residues of concern were <0.01­ 0.16 ppm in/ on eight samples of sorghum grain harvested 69­ 98 days following a single preemergence application of the 4 lb/ gal FlC formulation at 1.5 lb ai/ A (1x the maximum preemergence application rate) followed by a single postemergence application of the 50% DF formulation at 1.0 lb ai/ A (1x the maximum postemergence 44 application rate). Samples were stored frozen up to 364 days prior to analysis, which is within the 1­ year interval that linuron residues have been shown to be stable in grain crops. Data reviewed in the 6/ 82 Reregistration Standard indicate that linuron residues of concern were <0.05­ 0.27 ppm in/ on sorghum grain harvested 72­ 111 days following a single postemergence application of a 50% WP formulation at 1.0 lb ai/ A (1x the maximum registered postemergence application rate); tolerance­ exceeding residues (0.27 ppm) were observed at the 72­ and 74­ day harvest intervals. No information pertaining to sample storage conditions and intervals is available for this study. The registrants are required to specify a preharvest interval for postemergence use on sorghum (see Directions for Use). If a PHI greater than 74 days is specified, then no increase in the sorghum grain tolerance will be required. No data were submitted for sorghum aspirated grain fractions, however, the Agency recommended that a waiver be granted for residue data on sorghum aspirated grain fractions because residues did not concentrate in sorghum processed commodities flour or starch. Wheat, grain and aspirated grain fractions: There are three linuron EPs (EPA Reg. Nos. 1812­ 245, 19713­ 97, and 51036­ 78) currently registered for use on winter wheat (drill planted) in ID, OR, and WA. The 2/ 94 RED and the 2/ 95 RED Addendum concluded that no additional field trial data are required for wheat grain. Data reported in MRID 42605901 indicate that the linuron residues of concern were nondetectable (< 0.03 ppm) in/ on two samples of wheat grain harvested 128 days following a single postemergence application of the DF formulation at 2.5 or 5.0 lb ai/ A (1.4x or 2.9x the maximum seasonal rate for areas west of the Cascade Range and 3.3x or 6.7x the maximum seasonal rate for areas east of the Cascade Range). No data are available for the current maximum rates of 1.75 lb ai/ A, for west of the Cascade Range, and 0.75 lb ai/ A, for east of the Cascade Range. Samples were stored frozen for up to 5 months prior to analysis, which is within the 1­ year interval that linuron residues have been shown to be stable in grain crops. There are no crop field trial data available for wheat aspirated grain fractions, however, no residue data for aspirated grain fractions of wheat are required because linuron is registered for use on wheat during the early vegetative stage (preemergence, early postemergence or semi­ dormant) and/ or before the reproduction stage begins and seed heads are formed. In addition, the requirements for a wheat processing study were waived because the magnitude of the residue study performed to obtain wheat grain for processing employed a 6.7x treatment rate and nondetectable residues (< 0.03 ppm) were observed (DP Barcode D185892, 1/ 15/ 93, R. Perfetti). Prior to cancellation of their linuron products, Dupont proposed canceling the use on wheat in the U. S., but maintaining the tolerances for wheat commodities to support imported commodities, primarily from Canada. HED reviewed this request and concluded that additional data/ information pertaining to use patterns, export quantities, and the residue data used to support the import tolerances would be required before the Agency could recommend for any import tolerances (DP Barcode D227293, 1/ 7/ 97, C. Olinger). 45 Forage, Fodder, and Straw of Cereal Grains Group Barley, oats, and rye (forage, hay, and straw): There are no longer registered uses of linuron on barley, oats, and rye. Applicable tolerances have been revoked since the 2/ 95 RED Addendum. Corn, field, forage and stover: The 2/ 94 RED concluded that additional residue data for field corn forage and fodder must be submitted because Craven data were submitted to support reregistration of linuron on field corn. Craven replacement data (MRIDs 42948501 and 43044101) reflecting two different treatments, differing only in the timing of postemergence application were submitted and deemed acceptable (D196857, 12/ 15/ 93, D. McNeilly and DP Barcode D198851, 3/ 28/ 94, D. McNeilly, respectively). The 2/ 95 RED Addendum concluded that no additional field trial data were required for field corn forage and fodder. Field corn forage data indicate that the linuron residues of concern will not exceed the established tolerance of 1.0 ppm in/ on field corn forage harvested 58­ 73 days following a single preemergence application of the DF formulation at 1.5 lb ai/ A followed by a single directed postemergence application at 1.5 lb ai/ A for a total rate of 3.0 lb ai/ A. Linuron residues of concern from the single preemergence plus single directed postemergence application were 0.023­ 0.54 ppm in/ on nine samples of field corn forage. Field corn fodder data indicate that the linuron residues of concern will exceed the established tolerance of 1.0 ppm in/ on field corn fodder (stover) harvested 57­ 65 days following a single preemergence application of the DF formulation at 1.5 lb ai/ A followed by a single directed postemergence application at 1.5 lb ai/ A for a total rate of 3.0 lb ai/ A. Linuron residues of concern from the single preemergence plus single directed postemergence application were 0.1­ 5.5 ppm in/ on nine samples of field corn fodder. The data for corn fodder (stover) showed five of nine samples had tolerance­ exceeding residues (> 1 ppm). Storage stability information for these samples was not discussed in the study review. Data from additional field corn forage and fodder field trials (MRID 40537601) indicate that linuron residues will not exceed the established tolerance in/ on field corn forage and fodder. Linuron residues of concern were as follows: (i) 0.37­ 0.87 ppm in/ on three forage, silage, and whole plant samples harvested 98­ 116 days following a single postemergence application of the 4 lb/ gal FlC formulation at 1.5 lb ai/ A (1x the maximum postemergence application rate); (ii) 0.065 and 0.11 ppm in/ on two forage samples harvested 47 days following a single preemergence application of the 4 lb/ gal FlC formulation at 0.75 and 1.5 lb ai/ A (0.5x and 1x the maximum preemergence application rate) one day after planting; and (iii) <0.05­ 0.1 ppm in/ on six forage samples harvested 70 days following a single preemergence application of the 50% DF formulation at 0.5­ 1.65 lb ai/ A (0.4­ 1x the maximum preemergence application rate). Samples were stored frozen for 92­ 638 days prior to analysis, which is within the 2­ year interval that linuron residues have been shown to be stable in leafy vegetable crops. Data from an additional field corn grain field trial (MRID 00163267) indicate that linuron residues were nondetectable (< 0.05 ppm) in/ on 31 samples of field corn fodder harvested 128­ 150 days after planting following a single preemergence application of the DF formulation at 0.5­ 1.5 lb ai/ A (0.3­ 1x the maximum preemergence application rate). Storage stability information for these samples was not discussed in the study review. 46 Corn, pop, stover: There are no registered uses of linuron on popcorn. Corn, sweet, forage and stover: The 2/ 94 RED and the 2/ 95 RED Addendum required additional data for sweet corn forage, but concluded that sweet corn fodder (stover) was no longer considered a significant livestock feed item. However, Table 1 has been updated, and HED now requires field trial data for sweet corn stover. Crop field trial data for sweet corn commodities were submitted by Griffin; these data are inadequate to fulfill reregistration requirements because of incomplete geographic representation. An additional three crop field trials must be conducted in Regions 1 (1 trial) and 5 (2 trials). In addition, because Griffin had deleted uses on sweet corn from product labels, a use on sweet corn must be proposed. Although inadequate, the field trial data indicate that linuron residues of concern were below the LOQ (< 0.01 ppm) to 2.44 ppm in/ on sweet corn forage and 0.0189 to 4.00 ppm in/ on sweet corn stover harvested at maturity following a single soil directed application of the 50% DF or 4 lb/ gal FlC formulation at 1.48­ 1.57 lb ai/ A made when sweet corn plants were at least 15 inches tall. Samples were stored frozen for up to 7 months prior to analysis; a supporting storage stability study is ongoing. Sorghum, forage and stover: The 2/ 94 RED and the 2/ 95 RED Addendum concluded that no data for sorghum forage and fodder (stover) have been submitted in response to the Update. Data pertaining to residues in/ on sorghum forage and fodder (stover) following a single postemergence application of the 50% DF or 4 lb/ gal FlC formulation at the maximum registered rate remain outstanding. Wheat, forage, hay, and straw: At the request of the Agency, Dupont previously submitted a petition (PP# 4F4293) to increase linuron tolerances on wheat straw (CBTS No. 13020, DP Barcode D197620, 3/ 9/ 94, D. McNeilly). No data were submitted or are available for wheat forage and hay. These data are required. Restrictions against the feeding of wheat forage are not considered practical, and the Agency now requires field trial data for wheat hay. There are three linuron EPs (EPA Reg. Nos. 1812­ 245, 19713­ 97, and 51036­ 78) currently registered for use on winter wheat (drill planted) in ID, OR, and WA. The 2/ 95 RED Addendum concluded that no additional field trial data are required for wheat straw. Data reported in MRID 42605901 indicate that the linuron residues of concern exceeded the established tolerance of 0.5 ppm in/ on wheat straw, grown in OR, harvested 128 days following a single postemergence application of the DF formulation at 2.5 lb ai/ A (1.4x the maximum seasonal rate for areas west of the Cascade Range, and 3.3x the maximum seasonal rate for areas east of the Cascade Range). Linuron residues of concern from the single postemergence application were 0.64 and 2.0 ppm in/ on two samples of wheat straw following application at a slightly exaggerated rate (1.4x). No data are available for the current maximum rates of 1.75 lb ai/ A, for west of the Cascade Range, and 0.75 lb ai/ A, for east of the Cascade Range. Samples were stored frozen for up to 5 months prior to analysis. These data indicate that a higher tolerance is needed; a 2­ ppm tolerance is recommended, as proposed in PP# 4F4293 (CB No. 16149, DP Barcode D218971, 10/ 3/ 95, S. Hummel). Alternatively to proposing a higher tolerance, the registrants may wish to conduct wheat straw field trials, in conjunction with the required 47 wheat forage and hay field trials, which reflect application to winter wheat at the current maximum registered rates. Miscellaneous Commodities Asparagus: The 2/ 94 RED and the 2/ 95 RED Addendum concluded that additional data for asparagus reflecting application of the 4 lb/ gal FlC formulation at the maximum registered rate were required; these data were required to be submitted by linuron registrants other than Dupont. In addition, it was concluded that a higher tolerance for asparagus must be proposed. Residue data (MRID 41452601) previously evaluated (CB Nos. 6663 and 6994, 3/ 26/ 91, R. Perfetti) were reevaluated in conjunction with the petition request (PP# 5E04464; DP Barcode D211335, 5/ 9/ 95, W. Cutchin) by IR­ 4 to increase the tolerance for asparagus from 3 ppm to 7 ppm. These data indicate that linuron residues of concern were 0.4­ 5.0 ppm in/ on asparagus harvested 1 or 2 days following four applications (one at preemergence, a second at early emergence, followed by two postemergence applications) at 1.0 lb ai/ A/ application for a total rate of 4.0 lb ai/ A (1x the maximum seasonal rate). If the maximum residue of 5.0 ppm is corrected for method recovery (74%) the maximum residue would be 6.8 ppm. Samples were stored frozen for 532­ 634 days prior to analysis, which is within the 2­ year interval that linuron residues have been shown to be stable in leafy vegetable crops.. These data are adequate to satisfy data requirements for asparagus; the tolerance for asparagus has been increased to 7 ppm. Cotton, seed and gin byproducts: The 2/ 94 RED and the 2/ 95 RED Addendum concluded that no additional data were required for cotton because a Federal Register Notice (3/ 4/ 92) was issued cancelling use of Dupont products on cotton. Subsequently, Griffin Corporation submitted cotton field trial data (MRID 45302201) in support of reregistration. The submitted cotton field trial data, in conjunction with field trial data reviewed previously in the 6/ 82 Reregistration Standard and Agency memorandum (CB Nos. 6663 and 6994, 3/ 26/ 91, R. Perfetti), are adequate to satisfy data requirements for cottonseed but are inadequate to satisfy data requirements for cotton gin byproducts. For the gin byproducts field trials, information describing the type of equipment used for harvesting in the machine­ harvest trials must be submitted. In addition, additional cotton gin byproducts field trials must be conducted, such that the requirements of GLN 860.1000 (Table 1) for gin byproducts field trials are fulfilled, or a justification for the substitution of data from field trials reflecting hand harvesting must be submitted. Field trial data (MRID 41569901) indicate that linuron residues of concern were nondetectable (< 0.05 ppm) in/ on cottonseed harvested 76­ 107 days following a single postemergence broadcast application with the 4 lb/ gal FlC and 50% DF formulation to 20­ inch tall cotton plants at 1.5 lb ai/ A (1x the 48 maximum registered rate). Samples were stored frozen for 524­ 551 days prior to analysis, which is within the 2­ year interval that linuron residues have been shown to be stable in oilseeds. Although inadequate, the submitted gin byproducts field trial data indicate that linuron residues of concern were nondetectable (< 0.01 ppm) to 8.14 ppm in/ on cotton gin products harvested 54­ 104 days following application of either the 50% DF or 4 lb/ gal FlC formulation as follows: (i) a single layby application at 1.48­ 1.58 lb ai/ A (-1x the maximum registered seasonal rate); or (ii) two split applications at 0.75 lb ai/ A/ application, for a total application rate of 1.50­ 1.53 lb ai/ A (-1x the maximum registered seasonal rate). Samples were stored frozen for 14­ 66 days prior to analysis; a supporting storage stability study is ongoing. 7. Magnitude of the Residue in Processed Food/ Feed The reregistration requirements for the magnitude of the residue in processed food/ feed are fulfilled for field corn, cotton, soybeans, and wheat. An acceptable cottonseed processing study has been submitted to satisfy the requirements identified in the the 2/ 94 RED and the 2/ 95 RED Addendum. The 2/ 94 RED and 2/ 95 RED Addendum also concluded that additional data were required to upgrade an existing potato processing study (S. Knizner, 9/ 2/ 92); these data remain outstanding. Outstanding potato processing data are considered confirmatory; sufficient data are available to reassess tolerances and estimate dietary exposure for potato processed products. A summary of the available data and reregistration status for each commodity is presented below. Corn, field: The 2/ 94 RED and the 2/ 95 RED Addendum concluded that no additional data were required for the processed commodities of field corn. An acceptable field corn processing study has been submitted (MRID 42560001; DP Barcode D188001, 7/ 13/ 93, D. McNeilly). The data indicate that linuron residues of concern do not concentrate in starch, grits, meal, flour, or crude or refined oil (from both wet and dry milling) processed from field corn grain bearing trace residues following treatment at 5x. No tolerances are required for the processed commodities of field corn. Processing factors were not calculated because residues in/ on all commodities were greater than or equal to the LOD of 0.003 ppm (except starch which bore nondetectable residues) but below the LOQ (< 0.01 ppm). The processing data also indicated that linuron residues of concern in light impurities and large screenings were approximately 3x those in the RAC. Samples were stored frozen for up to 12 months prior to analysis, which is supported by 12­ month storage stability data for corn grain, corn oil, and sorghum starch. Cotton: Acceptable residue data are available for cotton processed commodities (DP Barcode D271950, 9/ 24/ 01, J. Punzi). No concentration of linuron residues of concern was observed in cotton meal, hulls, and refined oil processed from cottonseed bearing detectable linuron residues of concern. No tolerances are required for the processed commodities of cotton. Samples were stored frozen for up to 2 months prior to analysis; a supporting storage stability study is ongoing. 49 Potato: The 2/ 94 RED and the 2/ 95 RED Addendum required additional information pertaining to sample storage, the processing protocol, and the LOQ determination, as well as an explanation for low method recovery from potato chips to upgrade the study (DP Barcode D181454, 9/ 2/ 92, S. Knizner). These data remain outstanding. Although inadequate, the processing data indicate that linuron residues of concern concentrate in wet peel waste (processing factor of 5.5x), chips (2.0x), dehydrated granules (3.4x), and oven­ baked potatoes (2.1x) but do not concentrate in peeled potato (0.82x) or mashed potato (0.61x). Samples were stored frozen for up to 20.5 months prior to analysis, which is supported by adequate storage stability data for potatoes and its processed commodities wet peel, dry peel, dehydrated granules, and mashed potatoes. HED had previously concluded that no tolerances for potato processed commodities would be required (DP Barcode D218971, 10/ 3/ 95, S. Hummel). The highest average residue of linuron found in field trials at the maximum rate (HAFT) is 0.07 ppm. [In another study linuron residues of concern were below the limit of quantitation of 0.14 ppm when potatoes were treated at a 2x rate. A HAFT of 0.07 ppm will be used for calculation purposes.] Using the processing factor of 3.4x and the HAFT, expected residues in potato granules would be 0.07 ppm x 3.4 = 0.24 ppm. Because this amount does not significantly exceed the reassessed potato tolerance of 0.2 ppm, no food additive tolerance is needed for granules. Because the processing factor for chips is less than that for granules, expected residues in chips would be less than those in granules. For processed potato waste, the same HAFT is used. Residues were found to concentrate in wet peel by 5.5x. In addition to wet peel, potato processing waste may contain cull potatoes and washing water. For the purposes of calculating expected residues, it was assumed that the dry matter content of wet peels is the same as the dry matter content of potatoes (20%). Potato processing waste has a dry matter content of 12%. The expected linuron residues of concern in potato processing waste will be no more than 0.07 ppm x 5.5x x 12%/ 20% = 0.23 ppm. The resulting residue does not significantly exceed the tolerance recommended for potatoes of 0.2 ppm. Thus, no tolerance is needed for linuron residues in processed potato waste. Sorghum, grain: HED does not currently require data for the processed commodities of sorghum. However, sorghum processing data (DP Barcode D187993, 11/ 18/ 93, D. McNeilly) submitted by Dupont indicate that linuron residues of concern do not concentrate in sorghum flour (processing factor of <0.44x) or starch (< 0.44x). Soybean: The available soybean processing data (CBRS No. 5858, 10/ 31/ 89, C. Olinger, and DP Barcode D182595, 3/ 18/ 93, D. McNeilly) indicate that linuron residues of concern do not concentrate significantly in hulls (processing factor of 0.5x), meal (1.2x), soapstock (0.7x), crude oil (0.2x), refined oil (0.2x), degummed oil (0.2x), tofu (0.3x), light impurities (0.9x), soybean milk (0.15x), or soybean kernels (0.9x). Residues were found to concentrate in soybean isolate (1.6x) and lecithin (2.3x). Samples were stored frozen for up to 19 months prior to analysis, which is supported by adequate storage stability data for soybean oil and tofu (18­ month storage interval). The Agency does not 50 currently establish tolerances for soybean isolate or lecithin. Tolerances for soybean processed commodities are not required. Wheat: HED granted a waiver for a wheat processing study for linuron (DP Barcode D185892, 1/ 15/ 93, R. Perfetti) based on the fact that linuron residues of concern were below the LOQ (< 0.03 ppm) in/ on wheat grain treated at an exaggerated rate of 6.7x. Note the "6.7x" rate is actually 6.7x the maximum rate for areas east of the Cascade Range but only 2.9x the maximum rate for areas west of the Cascade Range (and 2.9x the maximum rate currently registered). 8. Magnitude of the Residue in Meat, Milk, Poultry, and Eggs Reregistration requirements for magnitude of the residue in meat, milk, poultry, and eggs are fulfilled. Feeding study data are available depicting linuron residues of concern in animals. There are established tolerances for linuron residues of concern in the meat, fat, and meat byproducts of cattle, goat, hog, horses, and sheep. Tolerances for linuron residues of concern in milk and poultry commodities have not been established. The 2/ 94 RED and the 2/ 95 RED Addendum reassessed the established tolerances for meat, fat, and meat byproducts of cattle, goats, hogs, horses, and sheep at lower levels and concluded that no tolerances are required for poultry and eggs. Since the issuance of the RED and RED Addendum, crop field trial data for sweet corn forage and fodder and cotton gin byproducts have been submitted. Although additional field trial data are required for these commodities, the available data indicate that the estimated cattle dietary burden used in the 2/ 95 RED Addendum (3.1 ppm based on a diet of 50% corn grain and 50% corn fodder) is too low. The maximum theoretical dietary burdens of linuron to beef and dairy cattle, poultry, and swine are presented in the table below. We note that these dietary burdens are estimated because additional crop field trial data are required for several feed items (sweet corn forage and fodder, cotton gin byproducts, sorghum forage and fodder, and wheat forage, hay, and straw). 51 Calculation of maximum dietary burdens of linuron to livestock Feed Commodity % Dry Matter 1 % Diet 1 Estimated Residues Levels (ppm) 2 Dietary Contribution (ppm) 3 Beef Cattle Carrot, culls 12 25 1.00 2.08 Corn, sweet, forage 48 40 3.00 4 2.50 Cotton, gin byproducts 90 20 9.00 4 2.00 Cottonseed, meal 89 15 0.10 0.017 TOTAL BURDEN 100 6.60 Dairy Cattle Carrot, culls 12 25 1.00 2.08 Corn, sweet, forage 48 50 3.00 4 3.13 Cotton, gin byproducts 90 20 9.00 4 2.00 Cottonseed, meal 89 5 0.10 0.006 TOTAL BURDEN 100 7.22 Poultry Cottonseed, meal NA 20 0.10 0.02 Sorghum, grain NA 80 0.25 0.20 TOTAL BURDEN 100 0.22 Swine Carrot, culls NA 10 1.0 0.10 Sorghum, grain NA 90 0.25 0.225 TOTAL BURDEN 100 0.325 1 Table 1 (OPPTS Guideline 860.1000). 2 Reassessed tolerance based on data from field trials. 3 Contribution = [tolerance / % DM (if cattle)] X % diet). Poultry and swine diets are not corrected for % dry matter. 4 Estimated tolerance; additional crop field trial data are required. A summary of the available livestock feeding studies follows: Ruminant: Several dairy cattle feeding studies were discussed in the 6/ 82 Reregistration Standard. The results of these studies are summarized in the table below. Samples were analyzed for linuron residues of concern using Method I of PAM Vol. II. The LOQ was 0.05 ppm for each matrix. 52 Dosing Summary of residues from cow feeding studies Two cows at an average of 0.15 ppm (0.02x) for 37 days to obtain tissue samples; three cows at same level to obtain milk samples No detectable residues in milk or tissues. Milk was collected every three days during dosing (MRID 00018775). Two cows fed at an average of 0.25 ppm (0.03x) for 37 days Kidney samples bore residues of 0.06­ 0.07 ppm. No residues were detected in any other tissue (MRID 00018375). One cow at an average of 0.30 ppm (0.04x) for 30 days to obtain tissue samples; another cow at same level for milk samples Detectable residues observed in liver and kidney at 0.08 and 0.09 ppm, respectively. Residues in fat, muscle, and milk were not detectable. Milk was collected every other day during dosing (MRID 00018450). Two cows at 1.0 ppm (0.14x) for 30 days Detectable residues observed in liver and kidney at 0.36­ 0.50 and 0.65­ 0.67 ppm, respectively. Residues in milk, lean muscle, and subcutaneous fat were not detectable. Milk was collected every other day during dosing (MRID 00018209). Two cows at 50 ppm (6.9x) for 30 days Residues were 12.0 and 13.0 ppm in kidney, 11.0 and 13.0 in liver, 0.45 and 0.48 ppm in lean muscle, and 0.48 and 1.10 ppm in subcutaneous fat. Milk residues were 0.05­ 0.37 ppm, with the highest value observed on Day 27 of dosing; milk samples were collected every other day during dosing (MRID 00018210). Using the results from the feeding study at 50 ppm, expected residues at a 1x feeding level would be 1.9 ppm in liver and kidney, 0.07 ppm in muscle, 0.16 ppm in fat, and 0.05 ppm in milk. These data indicate that increased tolerances for liver and kidney are necessary but that the established tolerances for meat and fat may be reduced. A tolerance for milk must be proposed. The estimated dietary burden in swine is much less than that for beef and dairy cattle. If the results of the exaggerated rate cattle feeding study are used, expected levels of linuron residues of concern in swine commodities would be 0.08 ppm in liver and kidney, 0.007 ppm in fat, and 0.003 ppm in muscle. Therefore, the established tolerances for hog commodities may be reduced. Poultry: Two poultry feeding studies were discussed in the 6/ 82 Reregistration Standard. Following feeding of poultry (broilers) at 0.35 ppm (1.6x) or 1 ppm (4.5x) for 28 days, no detectable residues were observed in liver, skin, muscle, or fat; and no detectable residue were observed in tissues or eggs from laying hens fed 0.7 ppm linuron (3.2x) for 21 days (MRID 00018383). Samples were analyzed using Method I of PAM, Vol. II with an LOQ of 0.05 ppm. In addition, analysis of samples from the poultry metabolism study, in which hens were fed at 10 ppm (45x) for 5 days, using the enforcement method resulted in residues of 0.23 ppm in egg yolk, <0.01 ppm in egg white, 0.46 ppm in liver, 0.03 ppm in breast and thigh muscle, and 0.04 ppm in fat. If these levels are adjusted to a 1x feeding level, expected residues would be below 0.05 ppm. Therefore, no linuron tolerances for poultry commodities are needed. 53 9. Reduction of Residues All data for reduction of residues have been evaluated and deemed adequate except that additional information is required to upgrade existing potato and carrot cooking studies. The asparagus cooking study shows washing with water reduces residues by 40%. Boiling removes an additional 25% of the residues, while steaming had little or no effect on reducing residue levels in or on asparagus (D182590, 3/ 18/ 93, D. McNeilly). A carrot cooking study indicated that linuron residues of concern concentrate in peels (3.3x) but reduce after boiling (0.3x) or steaming (0.4x). Additional information pertaining to how the carrots were cooked and how the LOQs were determined is required to upgrade this study (D181455, 9/ 8/ 92, S. Knizner). The potato cooking study shows that linuron residues concentrate in oven­ baked potatoes (1.5x) and microwave­ baked potatoes (1.6x), but are reduced in boiled potatoes (0.48x). Additional information pertaining to the cooking procedures, LOQ determination, and sample handling/ storage is required to upgrade this study (D181454, 9/ 2/ 92, S. Knizner). 10. Confined and Field Accumulation in Rotational Crops All data for nature of the residue in confined rotational crops have been evaluated and deemed adequate. The requirement for field rotational crop studies has been waived. The registrants have several varying plantback intervals established on product labels (see Table 2). Some plantback restrictions are too general; e. g., "Do not follow treated sorghum with any fall crop, nor with sugar beets, tobacco, vegetables or potatoes in rotation." In addition, some of the plantback intervals are conflicting. For example, EPA Reg. Nos. 1812­ 245 and 1812­ 320 include the following contradictory plantback restrictions under the use directions for sorghum: "Do not follow treated sorghum with any fall crop, nor with sugar beets, tobacco, vegetables or potatoes in rotation. Sorghum or field corn may be replanted within 4 months; after 4 months any crop may be planted." The registrants must modify all rotational crop restrictions such that specific plantback intervals are defined (e. g., do not plant any crop within 4 months of application to treated sorghum). In addition, the registrants must provide justification for any plantback intervals on the product labels. 54 E. TOLERANCE REASSESSMENT SUMMARY 1. Tolerance Reassessments for Linuron Tolerances for residues of linuron are currently expressed in terms of linuron per se. Permanent tolerances are established for linuron residues in/ on several raw agricultural commodities and animal commodities under 40 CFR §180.184( a). A tolerance with regional restriction has been established for linuron residues in/ on parsley under 40 CFR §180.184( c). The tolerance expression under 40 CFR §180.184( a) and (c) should be revised as follows: "Tolerances are established for the combined residues of the herbicide linuron (3­( 3,4­ dichlorophenyl)­ 1­ methoxy­ 1­ methylurea) and its metabolites convertible to 3,4­ dichloroaniline, calculated as linuron, in or on the following raw agricultural commodities: ". The Agency has updated the list of raw agricultural and processed commodities and feedstuffs derived from crops (Table 1, OPPTS GLN 860.1000). As a result of changes to Table 1, diuron tolerances for certain RACs which have been removed from the livestock feeds table need to be revoked. Also, some commodity definitions must be corrected. A summary of linuron tolerance reassessments is presented in Table 5. Tolerances Listed Under 40 CFR §180.184( a): Pending label amendments for some crops, adequate residue data have been submitted to reassess the established tolerances for the following commodities, as defined: asparagus; carrots; corn, field, fodder; corn, field, forage; corn, grain; cottonseed; parsnips; potatoes; sorghum, grain; soybeans; wheat, grain; and wheat, straw. The available data indicate that the established tolerances for field corn fodder and wheat straw must be increased, that the established tolerances for asparagus, carrots, field corn forage, sorghum grain, and soybeans are reassessed at the same level, and that the tolerances for field corn grain, cottonseed, parsnips, potatoes, and wheat grain may be reduced. The tolerances for soybean forage and hay should be revoked, provided that all registrants modify product labels to include restrictions against the feeding of soybean forage and hay from treated plants to livestock. Adequate feeding study data have been submitted to reassess the established tolerances for the fat, meat, and meat byproducts of cattle, goats, hogs, horses, and sheep. The feeding study data indicate that separate tolerances are required for the liver and kidney of cattle, goats, horses, and sheep. The available data also indicate that the tolerances for the fat, meat, and meat byproducts of cattle, goat, horses, and sheep may be lowered, with the modification of the meat byproducts tolerances to state "meat byproducts, exc. liver and kidney". All tolerances for hog commodities may be lowered. 55 Inadequate residue data are available to reassess the established tolerances for: celery; corn, fresh; corn, sweet, fodder; corn, sweet, forage; sorghum, fodder; sorghum, forage; wheat, forage; and wheat, hay. The established tolerances for the following commodities should be moved to §180.184( c) because use of linuron on these crops is restricted to certain geographical areas: cottonseed, potatoes, and all wheat commodities. Tolerances To Be Proposed Under 40 CFR §180.184( a): The available crop field trial and feeding study data indicate that tolerances for linuron residues must be proposed for: milk; liver of cattle, goats, horses, and sheep; and kidney of cattle, goats, horses, and sheep. Tolerances Listed Under 40 CFR §180.184( c): Adequate data are available to reassess the established tolerance for parsley. Tolerances To Be Proposed Under 40 CFR §180.184( c): Because use of linuron on several crops is restricted to certain geographical areas, the established tolerances for the following commodities should be moved from §180.184( a) to §180.184( c): cottonseed, potatoes, and all wheat commodities. In addition, a tolerance for cotton gin byproducts must be proposed under §180.184( c); additional data are required before the appropriate tolerance level may be determined. Pending Tolerance Petitions: Dupont has proposed (PP# 4F4293) to increase the established tolerance for wheat straw from 0.5 ppm to 2.0 ppm. This proposal was based on crop field trial data which indicated that the established tolerance was too low. There are no outstanding residue chemistry deficiencies pertaining to this petition. Dupont proposed (PP# 0F3832) revisions to the established tolerances for potatoes and animal commodities as follows: 0.2 ppm for potatoes; 0.1 ppm for the fat, meat, and meat byproducts, except liver and kidney, of cattle, goats, hogs, horses, and sheep; and 1.0 ppm for the liver and kidney of cattle, goats, hogs, horses, and sheep. This petition is currently in reject status because of issues pertaining to product chemistry, potato and poultry metabolism, storage stability, crop field trials, processed commodities, and reduction of residues. 56 IR­ 4 has proposed a tolerance with regional registration (states east of the Mississippi River) for residues of linuron in/ on lettuce at 0.1 ppm (PP# 1E02486). There are no outstanding residue chemistry deficiencies pertaining to this petition. IR­ 4 has also proposed tolerances for residues of linuron in/ on taro (corms, including dasheen) and ginger at 1.0 ppm (PP# 3E2920). This petition is currently in reject status because of issues pertaining to product chemistry, storage stability, and field trial data. IR­ 4 has proposed a tolerance for residues of linuron in/ on lupin grain, forage, and hay (PP# 2E04419). This petition is currently in reject status because of issues pertaining to product chemistry, poultry metabolism, and crop field trials. 57 (continued; footnotes follow) 2. Tolerance Reassessment Table Table 5. Tolerance Reassessment Summary for Linuron. Commodity Current Tolerance (ppm) 1 Range of Residues (ppm) 2 Tolerance Reassessment (ppm) Comment/ Correct Commodity Definition Tolerances listed under 40 CFR §180.184( a): Asparagus 7.0 0.4­ 5.0 (0.5­ 6.8 when corrected for a 74% method recovery) 7.0 Carrots 1 0.08­ 0.60 1 [Carrot] Cattle, fat 1 0.16 3 0.2 Cattle, mbyp 1 0.07 3 0.1 [Cattle, meat byproducts, except kidney and liver] Cattle, meat 1 0.07 3 0.1 Celery 0.5 <0.05­ 0.42 (celery grown east of the Rocky Mountains) To be determined The available data support use east of the Rocky Mountains; additional data are required to support use on celery west of the Rocky Mountains. Corn, field, fodder 1 <0.05­ 5.5 6 [Corn, field, stover] Corn, field, forage 1 0.023­ 0.87 1 Corn, fresh (inc. sweet K+ CWHR) 0.25 <0.01­< 0.05 To be determined Additional crop field trial data are required. [Corn, sweet (K+ CWHR)] Corn, grain (inc. popcorn) 0.25 <0.01­ 0.06 0.1 Popcorn grain tolerance should be deleted since there are no registered uses. [Corn, field, grain] Corn, sweet, fodder 1 0.0189­ 4.00 To be determined Additional crop field trial data are required. [Corn, sweet, stover] Corn, sweet, forage 1 <0.01­ 2.44 To be determined Additional crop field trial data are required. Cottonseed 0.25 <0.05 Reassign This tolerance should be reclassified under 180.184( c) because use of linuron on cotton is restricted to east of the Rocky Mountains. Goats, fat 1 0.16 3 0.2 [Goat, fat] Table 5 (continued). Commodity Current Tolerance (ppm) 1 Range of Residues (ppm) 2 Tolerance Reassessment (ppm) Comment/ Correct Commodity Definition 58 (continued; footnotes follow) Goats, mbyp 1 0.07 3 0.1 [Goat, meat byproducts, except kidney and liver] Goats, meat 1 0.07 3 0.1 [Goat, meat] Hogs, fat 1 0.007 3 0.05 [Hog, fat] Hogs, mbyp 1 0.08 3 0.1 [Hog, meat byproducts] Hogs, meat 1 0.003 3 0.05 [Hog, meat] Horses, fat 1 0.16 3 0.2 [Horse, fat] Horses, mbyp 1 0.07 3 0.1 [Horse, meat byproducts, except kidney and liver] Horses, meat 1 0.07 3 0.1 [Horse, meat] Parsnips (with or without tops) 0.5 <0.05 0.05 [Parsnip, root] Potatoes 1 <0.01­ 0.07 Reassign This tolerance should be reclassified under 180.184( c) as use of linuron on potatoes is restricted to east of the Rocky Mountains. Sheep, fat 1 0.16 3 0.2 Sheep, mbyp 1 0.07 3 0.1 [Sheep, meat byproducts, except kidney and liver] Sheep, meat 1 0.07 3 0.1 Sorghum, fodder 1 ­­ To be determined [Sorghum, stover] Sorghum, forage 1 ­­ To be determined Sorghum, grain (milo) 0.25 <0.01­ 0.16 0.25 [Sorghum, grain] Soybeans, (dry or succulent) 1 <0.01­ 1.0 1 [Soybean, seed] Soybean, forage 1 Not applicable Revoke These tolerances should be revoked, provided all pertinent labels are amended to include the following feeding restriction on the product labels: "The feeding of treated forage or hay to livestock is prohibited. Soybean, hay 1 Not applicable Revoke Table 5 (continued). Commodity Current Tolerance (ppm) 1 Range of Residues (ppm) 2 Tolerance Reassessment (ppm) Comment/ Correct Commodity Definition 59 (continued; footnotes follow) Wheat, forage 0.5 ­­ Reassign These tolerances should be reclassified under 180.184( c), as use of linuron on wheat is restricted to ID, OR, and WA. Wheat, grain 0.25 <0.03 Reassign Wheat, hay 0.5 ­­ Reassign Wheat, straw 0.5 0.64­ 2.0 Reassign Tolerances needed under 40 CFR §180.184( a): Cattle, kidney Not applicable 1.9 3 2.0 Cattle, liver Not applicable 1.9 3 2.0 Goat, kidney Not applicable 1.9 3 2.0 Goat, liver Not applicable 1.9 3 2.0 Horse, kidney Not applicable 1.9 3 2.0 Horse, liver Not applicable 1.9 3 2.0 Milk Not applicable 0.05 3 0.05 Sheep, kidney Not applicable 1.9 3 2.0 Sheep, liver Not applicable 1.9 3 2.0 Tolerances established under 40 CFR §180.184( c): Parsley 0.25 <0.06­ 0.18 0.25 Tolerances needed under 40 CFR §180.184( c): Cotton, gin byproducts Not applicable <0.01­ 8.14 To be determined Additional field trial data and/ or information is required. Cottonseed 0.25 <0.05 0.05 This tolerance should be reclassified under 180.184( c) because use of linuron on cotton is restricted to east of the Rocky Mountains. [Cotton, undelinted seed] Potatoes 1 <0.01­ 0.07 0.2 This tolerance should be reclassified under 180.184( c) because use of linuron on potatoes is restricted to east of the Rocky Mountains. [Potato] Table 5 (continued). Commodity Current Tolerance (ppm) 1 Range of Residues (ppm) 2 Tolerance Reassessment (ppm) Comment/ Correct Commodity Definition 60 Wheat, forage 0.5 ­­ To be determined Crop field trial data are required. This tolerance should be reclassified under 180.184( c), because use of linuron on wheat is restricted to ID, OR, and WA. Wheat, grain 0.25 <0.03 0.05 This tolerance should be reclassified under 180.184( c), because use of linuron on wheat is restricted to ID, OR, and WA. Wheat, hay 0.5 ­­ To be determined Crop field trial data are required. This tolerance should be reclassified under 180.184( c), because use of linuron on wheat is restricted to ID, OR, and WA. Wheat, straw 0.5 0.64­ 2.0 2.0 The registrants may wish to generate additional crop field trial data at 1x instead of proposing an increased tolerance. This tolerance should be reclassified under 180.184( c), because use of linuron on wheat is restricted to ID, OR, and WA. 1 Expressed in terms of linuron per se. 2 Refer to sections on Magnitude of the Residue in Crop Plants, Magnitude of the Residue in Processed Food/ Feed, and Magnitude of the Residue in Meat, Milk, Poultry, and Eggs for detailed discussion of residues in plant and animal commodities. 3 Expected residues at a 1x feeding level. 3. Codex/ International Harmonization No maximum residue limits (MRLs) for linuron have been established by Codex for any agricultural commodity. In addition, no Canadian or Mexican MRLs have been established for linuron. Therefore, no compatibility questions exist with respect to U. S. tolerances. 61 F. BIBLIOGRAPHY 1. Study Citations 00018067 E. I. du Pont de Nemours & Company (1961) Residue Data ­ Linuron ­ Sweetcorn. (Unpublished study received Apr 8, 1963 under unknown admin. no.; CDL: 124702­ B) 00018076 E. I. du Pont de Nemours & Company (1967) Residue Information. (Unpublished study received Jan 10, 1968 under 352­ 270; CDL: 124701­ A) 00018087 California. Department of Food and Agriculture (19??) Determination of Linuron Residues on Asparagus. Undated method. (Unpublished study/ received Mar 20, 1973 under 3E1373; CDL: 093663­ B) 00018089 California. Department of Agriculture (1974) Linuron Recoveries from Asparagus by Alkaline Hydrolysis (200 gram samples). Method dated Jul 31, 1974. (Unpublished study received on unknown date under 3E1373; CDL: 093662­ B) 00018127 E. I. du Pont de Nemours and Company (1962) Determination of 3­( 3,4­ Dichlorophenyl) 1 methoxy­ 1­ methylurea (Linuron) in Soils and Plant Tissue. (Unpublished study received Nov 8, 1962 under 352­ 270; CDL: 026676­ D) 00018148 E. I. du Pont de Nemours & Company (1970) Residue Data: Table A. (Unpublished study received Sep 16, 1971 under 352­ 270; CDL: 125817­ A) 00018171 E. I. du Pont de Nemours & Company, Incorporated (1966) Results of Tests on the Amount of Residue in Crops Grown on Treated Soil. (Unpublished study received Oct 5, 1966 under 7F0542; CDL: 090665­ C) 00018172 E. I. du Pont de Nemours & Company, Incorporated (1963) Residue Data: Linuron Carrots Pre­ emergence Treatment. (Unpublished study received Oct 5, 1966 under 7F0542; CDL: 090665­ D) 00018173 Belasco, I. J. (1967) Absence of Tetrachloroazobenzene in Soils Treated with Diuron and Linuron. (Unpublished study received on unknown date under 7F0542; submitted by E. I. du Pont de Nemours & Co., Inc., Wilmington, Del.; CDL: 092830­ A) 00018175 E. I. du Pont de Nemours and Company (19??) Residue Data: Linuron ­ Diuron: Cereal Grains. (Unpublished study received Oct 14, 1966 under 7F0542; CDL: 092830­ D) 62 00018176 Reasons, K. M.; Furtick, W. R.; Atkeson, G. A.; et al. (1966) Additional Data in Support of Petition. (Unpublished study received Oct 14, 1966 under 7F0542; submitted by E. I. du Pont de Nemours& Co., Inc., Wilmington, Del.; CDL: 092830­ G) 00018206 E. I. du Pont de Nemours and Company (1962) Results of Tests on the Amount of Residue in Crops Grown on Treated Soil: [Linuron]. (Unpublished study received Apr 13, 1963 under PP0356; CDL: 092640­ E) 00018209 E. I. du Pont de Nemours & Company, Incorporated (1954?) Feeding Study at 1 PPM in Corn Fodder. (Unpublished study received Apr 13, 1963 under PP0356; CDL: 092640­ I) 00018210 E. I. du Pont de Nemours & Company, Incorporated (1954?) Feeding Study at 50 PPM in Total Daily Diet. (Unpublished study received Apr 13, 1963 under PP0356; CDL: 092640­ J) 00018375 E. I. du Pont de Nemours and Company (1962) Linuron Livestock Feeding Studies: Milk and Meat. (Unpublished study received Feb 7, 1963 under PP0356; CDL: 090386­ B) 00018382 E. I. du Pont de Nemours & Company (1962) Residue Data: Linuron ­ Sweetcorn ­ 1962. (Unpublished study received Apr 13, 1962 under 352­ 270; CDL: 090385­ D) 00018383 E. I. du Pont de Nemours and Company (1963) Linuron: Poultry Feeding Studies: Residue Data ­ Tissues and Eggs. (Unpublished study received Apr 13, 1962 under 352­ 270; CDL: 090385­ E) 00018443 E. I. du Pont de Nemours & Company, Incorporated (1970) The Results of Tests on the Amount of Linuron Residue Remaining on or in Celery including a Description of the Analytical Method Used. (Unpublished study received Apr 18, 1971 under 1E1148; submitted by Interregional Research Project No. 4, New Brunswick, N. J.; CDL: 090935­ A) 00018450 E. I. du Pont de Nemours and Company, Incorporated (1961) Du Pont Herbicide 326 Corn (Unpublished study received on unknown date under PP0356; CDL: 098656­ A) 00018775 E. I. du Pont de Nemours and Company, Incorporated (1961) Linuron ­ Livestock Feeding Studies. (Unpublished study received on unknown date under PP0356; CDL: 098656­ B) 00027624 E. I. du Pont de Nemours and Company (1966) Name, Chemical Identity, and Composition: [Linuron]. (Unpublished study received Oct 14,1966 under 7F0542; CDL: 092830­ E) 00027635 E. I. du Pont de Nemours & Company, Incorporated (1963) Results of Tests on the Amount of Residue in Crops Grown on Treated Soil: [Linuron]. (Unpublished study received Feb 18, 1963 under PP0413; CDL: 090447­ B) 63 00029932 Belasco, I. J. (1979) The Metabolism of 14C­ Phenyl Labeled Linuron in the Lactating Nanny Goat. (Unpublished study received Jan 21, 1980 under 352­ 270; submitted by E. I. du Pont de Nemours & Co., Wilmington, Del.; CDL: 241635­ C) 00159802 E. I. du Pont de Nemours & Co., Inc. (1978) Linuron Freezer Storage Study on Soybean and Sugarbeet Tops. Unpublished study. 14 p. 00163267 E. I. du Pont de Nemours & Co., Inc. (1986) Linuron Residue Study: Response to Special Review/ Reregistration Guidance Document ­ EPA Case No. 47 (6/ 29/ 84). Unpublished compilation. 159 p. 00164195 Fuesler, T. (1986) Metabolism of Carbon 14 ­Linuron in Field­ grown Soybean Plants: Document No. AMR­ 570­ 86. Unpublished study prepared by E. I. du Pont de Nemours & Co., Inc. 49 p. 00164196 Ferguson, E. (1986) Metabolism of Carbon 14 ­Linuron by Potato Plants: Document No. AMR­ 559­ 86. Unpublished study prepared by E. I. du Pont de Nemours & Co., Inc. 35 p. 40049201 McIntosh, C. (1986) Linuron Processing Studies ­ Potatoes: Du Pont Study No. AMR­ 587­ 86 No. 1. Unpublished study prepared in cooperation with National Food Laboratory and Enviro­ Bio­ Tech., Ltd. 33 p. 40084801 Ferguson, E. (1986) Metabolism of Carbon 14 ­Linuron by Corn Plants: Laboratory Project ID. AMR­ 642­ 86. Unpublished study prepared by E. I. du Pont de Nemours and Co., Inc. 64 p. 40104101 Erbes, D. (1986) Confined Accumulation Study of Phenyl( U)­ carbon 14 Linuron on Rotational Crops: Laboratory Project ID: AMR­ 609­ 86. Unpublished study prepared by E. I. du Pont de Nemours & Co., Inc. 53 p. 40210901 E. I. du Pont de Nemours & Co. (1987) Linuron Residue Study: Supplement: Response to Special Review/ Reregistration Guidance Document: Lab Project ID: 47. Unpublished compilation prepared in cooperation with Enviro­ Bio­ Tech, Ltd. 676 p. 40537601 E. I. du Pont de Nemours & Co., Inc. (1988) Linuron Residue Study: Response to Special Review/ Reregistration: Du Pont EPA Case No. 47. Unpublished study prepared by Enviro­ Bio­ Tech, Ltd. 268 p. 40730101 Erbes, D. (1988) Supplement to: Confined Accumulation Study of [Phenyl( U)­[ Carbon 14]] Linuron on Rotational Crops ...: Laboratory Project ID: AMR 609­ 86. Unpublished study prepared by E. I. du Pont de Nemours and Co., Inc. 85 p. 64 41189801 Baron, J. (1989) Linuron: Magnitude of Residue on Parsley: Project ID: IR­ 4 PR No. 925/ 3035/ 3629. Unpublished study prepared by Cornell University, IR­ 4 Northeast Region. 74 p. 41241201 Fujinari, E.; Guinivan, R. (1989) Reduction of Linuron Residues During Cooking of Carrots, Asparagus, and Potatoes: Laboratory Project ID AMR­ 587­ 86. Unpublished study prepared by E. I. du Pont de Nemours and Co., Inc. in cooperation with Enviro­ Bio­ Tech., Ltd. 83 p. 41241202 Guinivan, R. (1989) Magnitude of Residues of Linuron in Soybeans and Processed Products: Laboratory Project ID AMR­ 969­ 87. Unpublished study prepared by E. I. du Pont de Nemours and Co., Inc. in cooperation with The National Food Laboratory, Inc. and Enviro­ Bio­ Tech. Ltd. 66 p. 41377601 Eble, J. (1989) Magnitude of Lorox L and Lorox DF Herbicide Residues in Sorghum: Lab Project Number: AMR/ 1131/ 88. Unpublished study prepared by Morse Laboratories. 47 p 41452601 Elbe, J. (1990) Magnitude of Lorox L and Lorox DF Herbicide Residues in Asparagus: Lab Project No: ML89­ 0125­ DUP: AMR­ 1134­ 88. Unpublished study prepared by Morse Laboratories. 51 p. 41452701 Elbe, J. (1990) Magnitude of Lorox L Herbicide Residues in Potatoes: Lab Project Number: AMR­ 1132­ 88. Unpublished study prepared by Morse Laboratories. 47 p. 41501501 Eble, J. (1989) Magnitude of Lorox L and Lorox DF Herbicide Residues in Celery: Lab Project Number: AMR­ 1133­ 88. Unpublished study prepared by E. I. du Pont de Nemours & Co., Inc. 42 p. 41503401 Eble, J. (1990) Magnitude of Lorox L and Lorox DF Herbicide Residues in Cotton: Lab Project Number: AMR­ 1130­ 88. Unpublished study prepared by du Pont Agric. Products Dept., Glasgow Residue Lab. 47 p. 41569901 Eble, J. (1990) Magnitude of Lorox L and Lorox DF Herbicide Residues in Cotton: Lab Project Number: AMR­ 1130­ 88. Unpublished study prepared by E. I. du Pont de Nemours & Co. 47 p. 41716101 Brown, A. (1986) Supplement No. 1 to: Metabolism of [carbon 14] ­ Linuron by Potato Plants: Lab Project Number: AMR 559­ 86. Unpublished study prepared by E. I. du Pont de Nemours and Co., Inc. 20 p. 41716102 Brown, A. (1986) Supplement No. 1 to Metabolism of [carbon 14] ­ Linuron in Field­ grown Soybean Plants: Lab Project Number: AMR 570­ 86. Unpublished study prepared by E. I. du Pont de Nemours and Co., Inc. 25 p. 65 41716103 E. I. du Pont de Nemours and Co. (1990) Supplement No. 1 to: Linuron Residue Study: Supplement: Response to Special Review/ Reregistration Guidance Document­ EPA Case No. 47 (6/ 29/ 84): Lab Project Number: 47. Unpublished study prepared by Enviro­ Bio­ Tech, Ltd. 33 p. 41938101 Brown, A. (1991) Supplement #2 to: Metabolism of [Carbon 14] Linuron by Potato Plants (MRID 00164196): Lab Project Number: AMR 559­ 86. Unpublished study prepared by E. I. du Pont de Nemours and Co. 30 p. 42379901 McClory, J.; Tomic, D. (1992) Residues of Lorox Herbicide in Carrots as Affected by Cooking: Lab Project Number: AMR 1701­ 90: ML91­ 0259­ DUP. Unpublished study prepared by E. I. du Pont de Nemours and Comp., Morse Laboratories. 81 p. 42397201 McClory, J.; Tomic, D. (1992) Residues of Lorox Herbicide in Potatoes and their Processed Fractions: Lab Project Number: AMR 1698­ 90: 65388­ 01: ML90­ 0211­ DUP. Unpublished study prepared by E. I. du Pont de Nemours and Co., Arthur D. Little, Inc., and Others. 180 p. 42462901 McClory, J.; Jones, W.; Sund, R. et al. (1992) Residues of Lorox Herbicide in Soybeans and Its Processed Fractions: Lab Project Number: AMR 1699­ 90. Unpublished study prepared by E. I. du Pont de Nemours and Co. in cooperation with The Texas A& M University System. 68 p. 42462902 McClory, J.; Tomic, D. (1992) Residues of Lorox Herbicide in Asparagus as Affected by Cooking: Lab Project Number: AMR 1700­ 90: ML90­ 0258­ DUP. Unpublished study prepared by E. I. du Pont de Nemours and Co. in cooperation with Morse Laboratories, Inc. 70 p. 42542101 Brown, A. (1992) Plant Metabolism Study of [Phenyl( U)­ carbon 14] Linuron in Potatoes: Lab Project Number: AMR 2236­ 91. Unpublished study prepared by E. I. du Pont de Nemours and Company. 53 p. 42542102 McClory, J.; Devine, P. (1992) Residues of Lorox Herbicide in Grain Sorghum Seed and Its Processed Fractions: Lab Project Number: AMR 1918­ 91: LOR­ 1918­ 91: ML92­ 0324­ DUP. Unpublished study prepared by E. I. du Pont de Nemours and Company, Texas A& M, and Morse Labs, Inc. 88 p. 42548401 Brown, A. (1992) Plant Metabolism Study of [Phenyl( U)­ carbon 14] Linuron in Soybeans: Lab Project Number: AMR 2159­ 91. Unpublished study prepared by E. I. du Pont de Nemours and Co. 60 p. 42560001 McClory, J.; Tomic, D. (1992) Residues of Lorox Herbicide in Field Corn Grain and its Processed Fractions: Lab Project Number: AMR 1916­ 91: LOR­ 1916­ 91: ML92­ 0294­ DUP. Unpublished study prepared by E. I. DuPont de Nemours and Co. 116 p. 66 42605901 McClory, J.; Tomic, D. (1992) Residues of Linuron in Wheat and Wheat Straw Following Application of Lorox DF Herbicide: Lab Project Number: AMR 2136­ 92: LOR­ 2136­ 92. Unpublished study prepared by E. I. du Pont de Nemours and Co. and The Texas A &M University System. 59 p. 42635401 Hawkins, D.; Elsom, L.; Dighton, M.; et al. (1993) The Metabolism of (carbon 14)­ Linuron in Laying Hens: Lab Project Number: HRC/ DPT 267/ 921558: AMR­ 2200­ 91. Unpublished study prepared by Huntingdon Research Centre Ltd. 101 p. 42836701 McClory, J.; Jones, W.; Tomic, D. (1993) Freezer Storage Stability of Linuron on Fresh and Cooked Asparagus: Lab Project Number: AMR 2339­ 92. Unpublished study prepared by DuPont Agricultural Products. 44 p. 42836702 McClory, J.; Jones, W.; Tomic, D. (1993) Freezer Storage Stability of Linuron on Wheat Straw and Grain: Lab Project Number: AMR 2623­ 93. Unpublished study prepared by DuPont Agricultural Products. 40 p. 42913301 McClory, J.; Tomic, D. (1993) Freezer Storage Stability of Linuron On Potatoes and Its Processed Fractions: (Interim Report): Lab Project Number: AMR 2240­ 91: ML91­ 0280­ DUP: METH­ 65. Unpublished study prepared by E. I. du Pont de Nemours and Co. and Morse Labs, Inc. 91 p. 42948501 Lomax, N. (1993) Letter Sent to Office of Pesticide Programs dated Oct. 1, 1993 concerning preliminary results­ linuron­ magnitude of residue study on corn. Prepared by DuPont Agricultural Products. 5 p. 42974401 Jones, W.; Tomic, D. (1993) Freezer Storage Stability of Linuron on Fresh and Cooked Carrots: Lab Project Number: AMR 2442­ 92. Unpublished study prepared by E. I. du Pont de Nemours & Co. 39 p. 43039101 McClory, J.; Tomic, D. (1993) Residues of Linuron in Soybean Seed Following Application of Lorox DF Herbicide: Lab Project Number: AMR 2064­ 92: ML93­ 0368­ DUP. Unpublished study prepared by DuPont Agricultural Products and Morse Labs, Inc. 145 p. 43040001 McClory, J.; Tomic, D. (1993) Freezer Storage Stability of Linuron on Corn, Sorghum and Their Processed Fractions: Lab Project Number: AMR 2591­ 92: ML92­ 0360­ DUP: 65364. Unpublished study prepared by E. I. du Pont de Nemours & Co., Agricultural Products and Morse Laboratories, Inc. 63 p. 43044101 McClory, J.; Tomic, D. (1993) Residues of Linuron in Corn Forage, Seed, and Stover Following Applications of Lorax DF Herbicide: Final Report: Lab Project Number: AMR 2065­ 92: 67 ML93­ 0367­ DUP. Unpublished study prepared by DuPont Agricultural Products and Morse Labs, Inc. 186 p. 43104401 McClory, J.; Jones, W.; Tomic, D. (1994) Freezer Storage Stability of Linuron on Soybean Processed Fractions: Lab Project Number: AMR/ 2501/ 92. Unpublished study prepared by E. I. du Pont de Nemours and Co. 42 p. 43215901 Jones, W.; Tomic, D. (1994) Freezer Storage Stability of Linuron on Fresh Celery: Lab Project Number: AMR 2502­ 92. Unpublished study prepared by DuPont Agricultural Products. 39 p. 43215902 McClory, J.; Tomic, D. (1994) Freezer Storage Stability of Linuron on Potatoes and Its Processed Fractions: Supplement: Lab Project Number: AMR 2240­ 91: ML91­ 0280­ DUP. Unpublished study prepared by DuPont Agricultural Products and Morse Laboratories, Inc. 69 p. 43245101 Hawkins, D.; Elsom, L.; Dighton, M.; et al. (1994) The Metabolism of (carbon 14)­ Linuron in Laying Hens: Supplement 1 the Identification of Metabolite B: Lab Project Number: HRC/ DPT 267/ 921558: AMR 2200­ 91. Unpublished study prepared by Huntingdon Research Centre Ltd. 20 p. 43288301 Jones, W. (1994) Freezer Storage Stability of Linuron on Fresh and Cooked Carrots: Supplement: Lab Project Number: AMR/ 2442/ 92. Unpublished study prepared by E. I. du Pont de Nemours and Co. 31 p. 43288302 McClory, J.; Jones, W. (1994) Freezer Storage Stability of Linuron on Fresh and Cooked Asparagus: Lab Project Number: AMR/ 2339/ 92. Unpublished study prepared by E. I. du Pont de Nemours and Co. 46 p. 43356202 McClory, J.; Jones, W.; Tomic, D. (1994) Freezer Storage Stability of Linuron on Soybean Processed Fractions: Supplement No. 1: Lab Project Number: AMR/ 2501/ 92. Unpublished study prepared by DuPont Experimental Station. 49 p. 43356203 McClory, J.; Tomic, D. (1994) Freezer Storage Stability of Linuron on Corn, Sorghum and Their Processed Fractions: Supplement No. 1: Lab Project Number: AMR/ 2591/ 92: ML92/ 0360/ DUP. Unpublished study prepared by DuPont Experimental Station and Morse Laboratories, Inc. 45 p. 43681401 Lurvey, E. (1995) Linuron: Magnitude of Residue on Celery: Lab Project Number: 4936/ 91/ NYR44: 4936/ 91/ CA061: 4936/ 91/ OR025. Unpublished study prepared by IR­ 4. 223 p. 45302201 Mickelson, K. (2000) Magnitude of Linuron Residues in/ on Cotton and Processed Fractions of Cotton Resulting From Pro­ Emergence and Post­ Directed Applications of Lorox DF and 68 Linex 4L: Final Study Report: Lab Project Number: AA000903: GP00­ 021: CA1. Unpublished study prepared by American Agricultural Services, Inc. 217 p. 45444101 Willard, T (2000) Magnitude of Linuron Residues in/ on Sweet Corn Resulting From a Post­ Directed Applications of Lorox DF and Linex 4L: Final Study Report: Lab Project Number: AA000901: GP00­ 022. Unpublished study prepared by American Agricultural Services, Inc. 199 p. 69 (continued) 2. Agency Memoranda Citations Table 7. Agency Memoranda Citations. Date DP Barcode CB No. From To MRID Nos. Subject 8/ 12/ 85 ­­ 1244 J. Garbus R. Taylor/ J. Miller and I. Sunzenauer 00159802 Linuron: Reregistration and Special Review: Storage Stability Data. Accession No. 258681 10/ 29/ 86 ­­ 1317 J. Garbus I. Sunzenauer and R. Taylor 00163267 ID. No. 035506: Linuron: Reregistration and Special Review: Response to Data Call­ In. Additional Residue Data for Soybeans, Corn, Carrots, Asparagus, and Potatoes. Access. No. 264383 6/ 2/ 87 ­­ 2279 J. Garbus M. Boodee 40049201 ID. No. 0035506: Linuron: Reregistration and Special Review: Potato Processing Protocol. 6/ 2/ 87 ­­ 2333 J. Garbus M. Boodee 40210901 ID. No. 0035506: Linuron: Reregistration and Special Review: Response to Data Call­ In. Additional Residue Data for Soybeans, Corn, Carrots, Asparagus, and Potatoes. 12/ 24/ 87 ­­ 2838 L. Propst R. Taylor and M. Boodee and Toxicology Branch 40084801 Metabolism of 14C­ Linuron by Corn Plants. Data Requirement for the Linuron Registration Standard. 10/ 5/ 89 ­­ 5658 F. Griffith H. Jamerson 41189801 PP# 6E3416 Linuron on Parsley. Evaluation of the July 10, 1989 Amendment. (MRID #411898­ 01 (HED Project #9­ 1934) 10/ 31/ 89 ­­ 5858 C. Olinger R. Hundemann 41241201 and 41241202 Review of Linuron Cooking Studies (Carrots, Asparagus, Potatoes) and Soybean Processing Studies, ID No. 035506; Record No. 253170 4/ 25/ 90 ­­ None E. Zager L. Rossi None. Linuron Reregistration: Data Waiver Request for Residues of Lorox® on Parsnips Table 7 (continued). Date DP Barcode CB No. From To MRID Nos. Subject 70 (continued) 6/ 11/ 90 ­­ 6210­ 6215 F. Griffith R. Taylor and Toxicology Branch 00264283, 00265637, 00018375, 00029932, 00027635, 40210901, and 41241201 PP# 0F3832 Linuron on Potatoes; Meat, Fat, and Meat Byproducts of Cattle, Goats, Hogs, Horses, and Sheep. Review of Analytical Methods and Residue Data. 3/ 26/ 91 ­­ 6663 and 6994 R. Perfetti R. Engler and L. Rossi 41376601, 41452601, 41452701, 41569901, 41503401 and 41501501 E. I. du Pont de Nemours and Co., Inc.: Response to the Linuron Reregistration Standard: Cropfield [sic.] Trials 4/ 25/ 91 D160079 7523 R. Perfetti R. Engler and L. Rossi 41716101­ 41716103 E. I. du Pont de Nemours and Co., Inc.: Response to the Linuron Reregistration Standard: Residue Chemistry 8/ 5/ 91 D162080 7731 W. Wassell H. Jamerson and Toxicology Branch None PP# 1E02486. Linuron (Lorox® Weed Killer, EPA Reg. No. 352­ 270) in or on Lettuce. Evaluation of the amendment dated 2/ 21/ 91. 5/ 21/ 92 D167107 8391 P. Deschamp L. Rossi/ C. Peterson 41938101 Reregistration of Linuron. Qualitative Nature of the Residue in Plants (potato metabolism study). 5/ 21/ 92 D167107 8391 P. Deschamp L. Rossi/ C. Peterson 41938101 Reregistration of Linuron. Qualitative Nature of the Residue in Plants (potato metabolism study). 9/ 2/ 92 D181454 10368 S. Knizner L. Rossi and B. Burnam 42397201 Linuron. Section 6( a)( 2) Data. Review of "Residues of Lorox Herbicide in Potatoes and their Processed Fractions, Du Pont Project No. AMR 1698­ 90". 9/ 8/ 92 D181455 10370 S. Knizner C. Peterson 42379901 Linuron. Review of "Residues of Lorox Herbicide in Carrots as Affected by Cooking. Du Pont Project No. AMR 1701­ 90". 11/ 5/ 92 D181229 10326 M. Peters H. Jamerson None PP# 3E2920, Linuron (Lorox®, EPA Reg. No. 352­ 270) in or on Ginger and Taro (Corms); Evaluation of revised sections B and F. 1/ 15/ 93 D185892 11063 R. Perfetti L. Rossi and E. Saito None Response to the Linuron Reregistration Standard: Residue Chemistry Data Waiver request Table 7 (continued). Date DP Barcode CB No. From To MRID Nos. Subject 71 (continued) 3/ 18/ 93 D182595 10586 D. McNeilly C. Peterson 42462901 and 42462902 Linuron: Soybean processing and an asparagus cooking study. 5/ 10/ 93 D188028 11362 D. McNeilly P. Perreault 42605901 Linuron: Wheat Residue Data and a Waiver Request for Wheat Processing Study. 7/ 13/ 93 D188001 11360 D. McNeilly P. Perreault 42560001 Linuron: Corn Processing Study. 8/ 18/ 93 D179614 10061 R. Griffin H. Jamerson None PP# 2E04119, Linuron (Lorox®, EPA Reg. No. 352­ 270) in/ on Lupin. 9/ 5/ 93 D195090 12553 D. McNeilly P. Perreault 42836701 and 42836702 Storage Stability: Asparagus and Wheat. 11/ 18/ 93 D187993 11358 D. McNeilly P. Perreault 42542101 and 42542102 Linuron: Potato Metabolism Study, Sorghum Grain Processing Data, and a Waiver request for the Sorghum Grain Dust Study. 11/ 18/ 93 D187998 11359 D. McNeilly P. Perreault 42548401 Linuron Soybean Metabolism Study. 11/ 18/ 93 D188002 11361 D. McNeilly P. Perreault 42635401 Linuron Poultry Metabolism Study. 12/ 15/ 93 D196857 12835 D. McNeilly W. Allen 42948501 Linuron: 6( a)( 2) Report of Over­ tolerance Residues in or on Corn Fodder. 2/ 18/ 94 D194477 12392 D. McNeilly L. Rossi and E. Saito None Linuron Reregistration Eligibility Document (RED). 3/ 9/ 94 D197620 13020 and 13021 D. McNeilly V. Walters and P. Perreault None PP# 4F4293: Linuron, request to raise tolerance on wheat straw to 2.0 ppm. 3/ 16/ 94 D198859 13162 D. McNeilly P. Perreault 43039101 Linuron: Soybean Magnitude of the Residue Data. 3/ 16/ 94 D199375 13213 D. McNeilly P. Perreault 43104401 Linuron: Storage Stability of Linuron in/ on Soybean Processed Fractions. 3/ 28/ 94 D198851 13161 D. McNeilly P. Perreault and W. Allen 43044101 Linuron: Magnitude of the Residue in/ on Corn; 6( a)( 2) residue data. Date DP Barcode CB No. From To MRID Nos. Subject 72 3/ 29/ 94 D198861 13160 D. McNeilly P. Perreault 43040001, 42913301, and 42974401 Linuron: Storage Stability of Linuron in/ on Carrots, Corn, Potatoes, Sorghum, and Processed Fractions. 7/ 27/ 94 D204807 13915 D. Miller P. Perreault 43245101 Linuron. Response to Registrant's Supplemental Information re: Metabolism in Laying Hens. 9/ 23/ 94 D206666 14229 D. Miller K. Jones 43288301 and 43288302 Linuron: Addendum to RED. Storage Stability Study (fresh and cooked carrots and fresh and cooked asparagus). 1/ 11/ 95 D203624 and D207488 13789 and 14366 S. Hummel K. Jones 43215901, 43215902, 43356202, and 433562203 Linuron (035506), Reregistration Case No. 0047: Storage Stability of Linuron in/ on Celery, Corn, Potatoes, Sorghum, and Processed Fractions of Corn, Sorghum, and Soybeans. 2/ 21/ 95 D212230 15113 S. Hummel K. Jones None Linuron. (035506) Addendum to RED Residue Chemistry Chapter Reregistration Case No. 0047. 5/ 9/ 95 D211335 15011 W. Cutchin H. Jamerson and J. Smith None PP# 5E04464, Request for Increase in Tolerance. Linuron on Asparagus. 9/ 5/ 95 D218302 15998 D. Miller K. Jones None Linuron. (035506) CBRS Response to DuPont Certification re: Product Chemistry and Crop Field Trials (Asparagus and Carrots). GDLNs 61­ 2( a) and 171­ 4( k). 10/ 3/ 95 D218971 16149 S. Hummel K. Jones and P. Parsons None Linuron (035506) Tolerance Recommendations for RED. 10/ 13/ 95 D216614 and D216621 15772 and 15773 W. Cutchin R. Taylor 43681401 ID# s: 001812­ 00245 and 001812­ 00320, Request for Amended Use. Linuron on Celery. 1/ 7/ 97 D227293 17327 C. Olinger J. Redden None Reregistration of Linuron: Cancellation of Wheat Registration; Chemical No. 35506. Case No. 0047 9/ 24/ 01 D271950 None J. Punzi 45302201 Magnitude of the Residue in Cotton Gin Byproducts and a Cotton Processing Study. 9/ 21/ 01 D276294 None J. Punzi 45444101 Magnitude of the Residue in Sweet Corn Commodities 73

epa

2024-06-07T20:31:41.854373

regulations

EPA-HQ-OPP-2002-0079-0007

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICID ES AND TOXIC SUBSTANCES HED DOC. NO. 0050286 DATE: November 20, 2001 MEMORANDUM SUBJECT: LINURON ­ Report of the Hazard identification Assessment Review Committee FROM: Robert F. Fricke, Ph. D. Reregistration Branch 2 Health Effects Division (7509C) THROUGH: Jess Rowland, Co­ Chair and Elizabeth Doyle, Co­ Chair Hazard Identification Assessment Review Committee Health Effects Division (7509C) TO: Carmen Rodia Chemical Review Manager Special Review and Registration Division (7508C) CC: Tom Meyers (SRRD, 7508C) Carol Christensen (HED, RRB2, 7509C) PC CODE: 035506 On September 13 and 27, 2001 the Hazard Identification assessment Review Committee (HIARC) reviewed the toxicology data base of linuron and selected endpoints/ doses for various exposure assessments. The HIARC also evaluated the potential for increased susceptibility of infants and children from exposure to linuron as required by the Food Quality Protection Act (FQPA) of 1996. The conclusions drawn at these meetings are presented in this report. 2 Committee Members in Attendance Members in attendance: Ayaad Assaad, William Burnam, Jonathan Chen, Paula Deschamp Pamela Hurley, John Liccione, David Nixon, Jess Rowland (Co­ Chair), and Brenda Tarplee Members in absentia:. Elizabeth Doyle (Co­ Chair) and Elizabeth Mendez Also in attendance: Susan Makris, Carol Christensen, Ken Doctor, and Pauline Wagner Data evaluation / presentation: Robert F. Fricke Reregistration Branch 2 3 N H Cl Cl O N CH 3 O CH 3 Linuron (035506) 1 INTRODUCTION On September 13 and 27, 2001 the Health Effects Division's (HED) Hazard Identification Assessment Review Committee (HIARC) reviewed the recommendations of the toxicology reviewer for Linuron with regard to the acute and chronic Reference Doses (RfD), the toxicological endpoints for short (1­ 30 days)­ and intermediate (1­ 6 months)­ term dermal occupational exposure, and the endpoints for short­, intermediate­ and long­ term (greater than 6 months) inhalation occupational exposure. The potential for increased susceptibility of infants and children from exposure to Linuron was also evaluated. The conclusions drawn at this meeting are presented in this report. 2 HAZARD IDENTIFICATION 2.1 Acute Reference Dose (RfD) ­ Females 13+ Study Selected: Prenatal Oral Developmental/ Rat OPPTS 870.3700 MRID No.: 00018167 Executive Summary: In a developmental toxicity study (MRID 00018167), 27 presumed pregnant Crl: CD rats per group were administered 0, 50, 125, or 625 ppm of linuron (97% a. i.; Lot No. INZ­ 326­ 118) in the diet on gestation days (GD) 6­ 15, inclusive. Average doses to the treated dams were 5.0, 12.1, and 50 mg/ kg/ day, respectively. The day evidence of mating was found was designated GD 1. Maternal body weights and food consumption were recorded on GD 6, 10, 16, and 21. On GD 21, all surviving dams were sacrificed and all fetuses were weighed and examined for external malformations/ variations. Crown­ rump length was measured on each fetus. Approximately one­ half of the fetuses in each litter were fixed in Bouin's solution for visceral examination and the remaining one­ half were processed for skeletal examination. All animals survived to scheduled termination without the appearance of any treatmentrelated clinical signs of toxicity. Gross necropsy was unremarkable. No treatment­ related clinical signs of toxicity were observed. Body weight gains and food consumption by the low­ and mid­ dose groups were similar to the controls throughout the study. Body weights of the high­ dose group were significantly (p # 0.05) less than the control group on GD 10, 16, and 21. Food consumption by the high­ dose group was significantly (p # 0.05) less than that of the controls for the intervals of GD 6­ 10 and 10­ 16. 4 Therefore, the maternal toxicity LOAEL is 625 ppm (50 mg/ kg/ day) based on reduced body weight gains and food consumption. The maternal toxicity NOAEL is 125 ppm (12 mg/ kg/ day). No dose­ or treatment­ related effects were observed on fetal sex ratios, numbers of corpora lutea/ dam, implantations/ dam, live or dead fetuses/ dam, fetal body weights, or crown­ rump length. In the control, low­, mid­, and high­ dose groups post­ implantation loss was 5.8, 3.5, 4.4, and 14.0%, respectively, and the number of resorptions per litter with resorption was 1.6, 1.6, 1.2, and 2.1, respectively. No treatment­ related external or visceral malformations/ variations were noted. In the highdose group bipartite thoracic vetebral centra was observed in 7 fetuses from 7 litters and unopposed sternebrae were observed in 3 fetuses from 3 litters. These anomalies were not found in the control group and were considered indicative of developmental delays. Therefore, the developmental toxicity LOAEL is 625 ppm (50 mg/ kg/ day) based on increases in post­ implantation loss and in litter/ fetal resorptions. The developmental toxicity NOAEL is 125 ppm (12 mg/ kg/ day). This study is classified as Acceptable/ Guideline and does satisfy the guidelines for a developmental toxicity study [OPPTS 870.3700 (83­ 3a)] in rats. AcuteR D mg kg day UF mg kg day f = = 12 100 012 // () .// Dose and Endpoint for Establishing Acute RfD: NOAEL = 12 mg/ kg/ day, based on increases in post­ implantation loss and litter/ fetal resorptions at the LOAEL of 625 ppm (50 mg/ kg/ day). Uncertainty Factor( s): 100x (10x intraspecies variability, 10x interspecies extrapolation). Comments about Study/ Endpoint/ Uncertainty Factor( s): The developmental effects are presumed to occur following a single exposure of females of child­ bearing age and, therefore, are appropriate for this risk assessment. 2.2 Acute Reference Dose (RfD) ­ General Population An appropriate end point attributable to a single­ dosesment for this population subgroup was not available in the database. 5 2.3 Chronic Reference Dose (RfD) Study Selected: Chronic Toxicity (1­ Year)/ Dog 870.4100 (§ 83­ 1b) MRID No.: 40952601 Executive Summary: In a one­ year chronic toxicity study, linuron (96.2% a. i., Batch No. 6,569) was administered to groups of 4 male and 4 female beagle dogs in the diet at concentrations of 0, 10, 25, 125, or 625 ppm (MRID 40952601). Time­ weighted average doses for the treated groups were 0.29, 0.79, 4.2, and19 mg/ kg/ day, respectively, for males and 0.30, 0.77, 3.5, and 16 mg/ kg/ day, respectively, for females. No treatment­ related clinical signs of toxicity or mortalities were observed at any dose level. Body weights, body weight gains, and food consumption were not affected by treatment. No treatment­ related ophthalmological lesions or changes in urinalysis parameters were noted and gross necropsy was unremarkable. RBC counts, hemoglobin, and hematocrit were slightly (n. s.) decreased throughout the study in high­ dose males and females as compared with those of the controls. WBC and platelet counts were significantly (p # 0.05) increased in high­ dose females at 3, 6, and 9 months and platelet counts were increased (p # 0.05) in high­ dose males at 3 months. Met­ and sulfhemoglobin levels were significantly (p # 0.05) increased in the 625 ppm males and females at all time points as compared with those of the controls. In addition, for the 125 ppm groups methemoglobin levels were increased (p # 0.05) in males and females at 3 and 6 months while sulfhemoglobin levels were (p # 0.05) increased at 9 months in males and at 3, 9, and 12 months in females. Increased hematopoiesis was observed in the bone marrow from 3/ 4 high­ dose males and 4/ 4 high­ dose females, compared with none of the control males and only 1/ 4 control females. Cholesterol levels were increased in the high­ dose groups at all time points as compared with control levels with statistical significance (p # 0.05) attained at 3, 6, 9, and 12 months for males and 3 months for females. Absolute liver weights were slightly (n. s.) increased in the 625 ppm males and relative liver weights were significantly (p # 0.05) increased in the 125 and 625 ppm males. No effects on liver weights were noted in females. Increases in the incidence and/ or severity of brown pigment (hemosiderin) deposition in the liver were observed microscopically in high­ dose males and females. The LOAEL for linuron in male and female beagle dogs was established at 125 ppm (4.17 mg/ kg/ day in males and 3.5 mg/ kg/ day in females) based on abnormal hematology findings (increased met­ and sulfhemoglobin levels). The NOAEL was established at 25 ppm (0.79 mg/ kg/ day, males and 0.77 mg/ kg/ day, females). 6 This study is classified as Acceptable/ Guideline and satisfies the guideline requirements for a chronic toxicity study [OPPTS 870.4100 (83­ 1b)] in dogs. Dose and Endpoint for Establishing Chronic RfD: NOAEL = 0.77 mg/ kg/ day, based on increased met­ and sulfhemoglobin levels at the LOAEL (4.17 mg/ kg/ day in males and 3.5 mg/ kg/ day in females). Uncertainty Factor( s): 100x (10x intraspecies variability, 10x interspecies extrapolation). Comments about Study/ Endpoint/ Uncertainty Factor( s): The route of administration and duration of exposure are appropriate for establishing a chronic RfD. ChronicR D mg kg day UF mg kg day f = = 077 100 0 0077 .// () .// 2.4 Occupational Exposure 2.4.1 Oral Exposure 2.4.1.1 Short­ Term (1­ 30 days) Incidental Oral Exposure Study Selected: Reproduction and Fertility Effects/ Rat 870.3800 (§ 83­ 4) MRID No.: 41463401, 41864701 Executive Summary: In a two­ generation reproduction study, linuron (96.2% a. i.) was administered to groups of 30 male and 30 female Crl: CDBR rats in the diet at concentrations of 0, 12.5, 100, or 625 ppm (MRID Nos: 41463401, 41864701). One litter was produced by each generation. Average premating doses for the treated F0 groups were 0.74, 5.8, and 36 mg/ kg/ day, respectively, for males and 0.92, 7.33, and 45.1 mg/ kg/ day, respectively, for females. Average premating doses for the treated F1 groups were 0.948, 7.77, and 54.0 mg/ kg/ day, respectively, for males and 1.12, 9.24, and 63.0 mg/ kg/ day, respectively, for females. F0 and F1 parental animals were administered test or control diet for 72 or 75 days, respectively, prior to mating and throughout mating, gestation, and lactation, and until necropsy. No treatment­ related clinical signs of toxicity or mortalities were observed in the adult animals of either generation. Body weights, body weight gains, and food consumption were significantly (p # 0.05) less than those of the controls beginning on day 7 for the high­ dose F0 animals (19%, males; 14%, females) and throughout premating for the mid­ (6%, males; 8%, females) 7 and high­ (24%, males; 25%, females) dose F1 animals. At the high­ dose, overall weight gains in F0 males and females were decreased 59% and 55%, respectively, and for highdose F1 males and females, 76% and 75%, respectively. Mean daily food consumption levels for the high­ dose groups during the premating interval were 80­ 85% of the control levels. Absolute body weights of the mid­ dose F0 males were occasionally significantly (p # 0.05) less than the controls with premating weight gains and food consumption 88% and 94% (both, p # 0.05), respectively, of the control levels. For the mid­ dose F1 males and females, final premating body weights, body weight gains, and food consumption were 92­ 94% of the control levels. For the mid­ and high­ dose dams of both generations, lower body weights during gestation and lactation were considered a continuation of premating effects. No treatment­ related lesions were noted at necropsy of the F0 males or females. In highdose F1 males, gross lesions of the testes included reduced in size (9/ 30), abnormally large (3/ 30), soft (5/ 30), small epididymides (8/ 30), and unspecified deformities of the epididymides (5/ 30); these were noted as significant incidences, but control rates were not given in the original DER. Microscopically, increased incidences (p # 0.05) of testicular and epididymal lesions were found in high­ dose F1 males as compared with the controls: atrophy (14/ 30), fibrosis (8/ 30), and hyperplasia (7/ 30) in the testes and arteritis (6/ 30), inflammation (5/ 30), and oligospermia (12/ 30) in the epididymides. Only one incidence each of atrophy and oligospermia were observed in control animals. Absolute testes weights of the high­ dose F1 males were significantly (p # 0.05; 80% of control) less than the controls. In high­ dose F1 females, gross findings (n. s.) included cystic ovaries (4/ 30), dilatation (3/ 30), and fluid filled uterine horns (2/ 30), none of which were observed in control animals. In addition, lesions of the eye were noted in high­ dose F1 males and females and were reviewed in MRID 41864701. A significant (p # 0.05) increase was seen in the number of high­ dose F1 males with any type of corneal or conjunctival change (14/ 30 vs 4/ 30 controls). The lesions included corneal degeneration/ basophilia and conjunctival inflammation/ basophilia. Degeneration of the lens was observed in 3/ 30 high­ dose males and 3/ 29 high­ dose females compared with only 1/ 30 control male. However, a clear treatment­ related effect in females was not considered to be definitive. The systemic toxicity LOAEL was established at 100 ppm (average premating doses 5.8­ 9.24 mg/ kg/ day) based on reduced body weight gains in males and females during both generations. The systemic toxicity NOAEL was established at 12.5 ppm (average premating doses 0.74­ 1.12 mg/ kg/ day). No treatment­ related adverse effects were found on the reproductive performance of either generation. For the control, low­, mid­, and high­ dose group, pup viability for lactation days 0­ 4 was 99.4, 98.0, 99.8, and 91.7% (p # 0.05), respectively, for the F1 generation and 96.8, 92.7, 99.5, and 76.2% (p # 0.05), respectively, for the F2 generation. The mean number of pups per litter in the high­ dose F2 group was significantly (p # 0.05) less than the control throughout lactation. The number of litters 8 with pups showing clinical signs was significantly (p # 0.05) increased in both generations. Body weights of the mid­ and high­ dose F1 male and female pups and of the high­ dose F2 male and female pups were significantly (p # 0.05) less than those of the controls throughout lactation. These data were not considered for setting the reproductive toxicity NOAEL in the original DER. The reproductive toxicity NOAEL was greater than or equal to 625 ppm (average premating doses 36­ 63.0 mg/ kg/ day) and the reproductive toxicity LOAEL was not established. This study is classified as Acceptable/ Guideline and satisfies the guideline requirements for a reproductive toxicity study [OPPTS 870.3800 (83­ 4)] in rats. Dose and Endpoint Selected: 5.8 mg/ kg (maternal NOAEL) based statistically and biologically significant decrease in premating body weights in F0 and F1 animals observed at 36 mg/ kg/ day. Comments about Study/ Endpoint: The systemic toxicity (body weight decrease) is relevant for the populations (infants and children) and duration (1 ­ 30 days) of concern. The NOAEL of 5.8 mg/ kg/ day used for this exposure period is based on the decrease in body weight seen during days 1 through 30 at 36 mg/ kg/ day and is used only for this risk assessment. This NOAEL/ LOAEL differs from the overall NOAEL/ LOAEL (0.7/ 5.8) established for the study. In an open literature publication [McIntyre, B. S. et al., Toxicol Appl Pharmacol 167( 2): 87­ 99 (2000)] the effects observed (retention of areolae/ nipples in male rats) at 12.5 mg/ kg/ day were not considered to be biologically significant for risk assessment since the findings were not replicated in any other studies. . 2.4.2 Intermediate­ Term (1 to 6 Months) Incidental Oral Exposure Study Selected: One­ year chronic study ­ Dog 870.4100 (§ 83­ 1b) MRID No.: 40952601 Executive Summary: See Chronic RfD (2.3) Dose and Endpoint Selected: 0.77 mg/ kg/ day, based on increased met­ and sulfhemoglobin concentrations at 3.5 mg/ kg/ day. Comments about Study/ Endpoint: The effects seen in this study after 3 and 6 months treatment were within the time frame for intermediate­ term exposure. 2.5 Dermal Absorption 9 Study Selected: Dermal penetration 870.7600 (§ 85­ 2) MRID No.: 163837 Executive Summary: In this dermal absorption study, four groups of 20 rats (one female group and three male groups) were dosed with 14 C (2.35 : Ci/ mg) linuron at 0.12, 1.00, or 7.4 mg/ 2 in 2 (2.82, 23.5, or 17.4 : Ci, respectively). Based on the results of this study, a dermal absorption factor of 16% was observed for an exposure of 8 to 10 hr (2%/ hr). Percentage (%) Dermal Absorption: 16% for 8 to 10 hour exposure (2% per hour) 2.6 Dermal Exposure 2.6.1 Short­ Term (1­ 30 days) Dermal Exposure Study Selected: Reproduction and Fertility Effects/ Rat 870.3800 (§ 83­ 4) MRID No.: 41463401, 41864701 Executive Summary: See short­ term oral exposure (2.4.1.1) Dose and Endpoint Selected: Parental NOAEL of 5.8 mg/ kg based statistically and biologically significant decrease in premating body weights in F0 and F1 animals observed at 36 mg/ kg/ day. Comments about Study/ Endpoint: No repeat dose dermal toxicity study is available. Therefore, an oral NOAEL of 5.8 mg/ kg/ day was selected for this exposure period. The NOAEL used for this exposure period is based on the decrease in body weight seen during days 1 through 30 at 36 mg/ kg/ day and is used only for this risk assessment. This NOAEL/ LOAEL differs from the overall NOAEL/ LOAEL (0.7/ 5.8) established for the study. A dermal absorption factor of 16% should be used for route to route extrapolation. 2.6.2 Intermediate (1 to 6 Months) Term Dermal Exposure Study Selected: One­ year chronic study ­ Dog 870.4100 (§ 83­ 1b) MRID No.: 40952601 Executive Summary: See Chronic RfD (2.3) Dose and Endpoint Selected: 0.77 mg/ kg/ day, based on increased met­ and sulfhemoglobin concentrations after 3 and 6 months treatment at 3.5 mg/ kg/ day. 10 Comments about Study/ Endpoint: No repeat dose dermal toxicity study is available. The systemic toxicity (increased met­ and sulfhemoglobin concentrations) is relevant for this duration (seen after 3 and 6 months). A dermal absorption factor of 16% should be used for route to route extrapolation. 2.6.3 Long­ term (greater than 6 months) Dermal Exposure Study Selected: One­ year chronic study ­ Dog 870.4100 (§ 83­ 1b) MRID No.: 40952601 Executive Summary: See Chronic RfD (2.3) Dose and Endpoint Selected: 0.77 mg/ kg/ day; based on increased met­ and sulfhemoglobin concentrations after 9 and 12 months treatment at 3.5 mg/ kg/ day. A dermal absorption factor of 16% should be used for route to route extrapolation. Comments about Study/ Endpoint: This dose and endpoint were selected to establish the chronic RfD. A dermal absorption factor of 16% should be used for route to route extrapolation. 2.7 Inhalation Exposure 2.7.1 Short­ Term (1­ 30 days) Inhalation Exposure Study Selected: Reproduction and Fertility Effects/ Rat 870.3800 (§ 83­ 4) MRID No.: 41463401, 41864701 Executive Summary: See short­ term oral exposure (2.4.1.1) Dose and Endpoint Selected: Parental NOAEL of 5.8 mg/ kg based statistically and biologically significant decrease in premating body weights in F0 and F1 animals observed at 36 mg/ kg/ day. Comments about Study/ Endpoint: In the absence of an inhalation study, an oral study was selected. The NOAEL used for this exposure period is based on the decrease in body weight seen during days 1 through 30 at 36 mg/ kg/ day and is used only for this risk assessment. This NOAEL/ LOAEL differs from the overall NOAEL/ LOAEL (0.7/ 5.8) established for the study. 2.7.2 Intermediate­ Term (1 to 6 Months) Incidental Inhalation Exposure Study Selected: One­ year chronic study ­ Dog 870.4100 (§ 83­ 1b) 11 MRID No.: See Chronic RfD (2.3) Executive Summary: See Chronic RfD (2.3) Dose and Endpoint Selected 0.77 mg/ kg/ day, based on increased met­ and sulfhemoglobin concentrations after 3 and 6 months treatment at 3.5 mg/ kg/ day. Comments about Study/ Endpoint: In the absence of an inhalation study, an oral study was selected. 2.7.3 Long­ term (greater than 6 months) Inhalation Exposure Study Selected: One­ year chronic study ­ Dog 870.4100 (§ 83­ 1b) MRID No.: See Chronic RfD (2.3) Executive Summary: See Chronic RfD (2.3) Dose and Endpoint Selected: 0.77 mg/ kg/ day, based on increased sulfhemoglobin concentrations after 9 and 12 months treatment at 3.5 mg/ kg/ day. Comments about Study/ Endpoint: See Chronic RfD (2.3) 2.8 Margins of Exposure for Occupational Risk Assessments Margin of exposure of 100 is adequate for occupational dermal and inhalation exposure risk assessments. The MOEs for residential use will be determined by the FQPA Safety Factor Committee. 3 CLASSIFICATION OF CARCINOGENIC POTENTIAL 3.1 Combined Chronic Toxicity/ Carcinogenicity Study in Rats MRID No.: 00029680, 00029679 Executive Summary: In a chronic toxicity/ oncogenicity study (MRID 00029680 and MRID 00029679), INZ­ 326 (Linuron; 96.9­ 97.2% a. i.; Lot No. 20427, Batch No. 90, E 6110­ 29B) was administered in the diet to groups of 70 ChR­ CD® rats/ sex/ dose at concentrations of 0, 50, 125, and 625 ppm (0, 2.09, 5.11, and 27.1 mg/ kg/ day for males and 0, 3.13, 7.75, and 48.3 mg/ kg/ day for females) for up to 2 years. Additional groups of 10 rats/ sex/ dose were administered the same diets for 12 months for interim evaluation. All clinical pathology data were reanalyzed (MRID 00164117) due to inappropriate statistical methods used in the original study report. 12 Linuron had no effect on mortality at any dose, and there were no treatment­ related clinical signs reported. Absolute body weights of the high­ dose male group were decreased to 88­ 91% of controls during weeks 1­ 19, with decreased body weight gain during weeks 0­ 13 and 52­ 104 resulting in body weight gain for the entire study being 89% of controls. Absolute body weights of the high­ dose female group were decreased throughout the study, with the magnitude of the decrease generally increasing throughout the course of the study. The body weight gain of this group for the entire study was 57% of controls. Body weight gain by mid­ dose males was decreased to 64% of controls during the week 52­ 76 interval, with body weight loss during the week 76­ 104 interval being increased to 148% of controls. Body weight gain by the mid­ dose female group was decreased to 75% of controls during the week 52­ 76 interval. There were no toxicologically significant treatment­ related effects on food consumption; however, food efficiency values of high­ dose females were decreased to 74­ 88% of controls during weeks 1­ 4 and to 58% of controls for the entire study period. Histopathology observations consistent with hemolysis were observed at increased incidences in high­ and mid­ dose males and females from the main study and interim sacrifice groups, including hemosiderin in Kupffer cells and increased hemosiderosis in bone marrow, spleen, and/ or mesenteric lymph nodes, and transient decreases in the erythrocyte count, hemoglobin concentration, and hematocrit of the high­ dose female group were noted at 6 and/ or 12 months. Male rats of the main study group had significantly increased incidences of mineralization/ calculi in the renal pelvis, transitional cell hyperplasia in the renal pelvis, and subacute perivasculitis and/ or vasculitis in the epididymides at the mid­ and high­ dose treatment levels. Female rats of the main study group had significantly increased incidences of calculi in renal tubules at the mid­ and high­ dose treatment levels and significantly increased incidences of hepatic sinusoidal ectasia and collecting duct ectasia in the kidney at the high­ dose treatment level. The high­ dose female group also had a non­ statistically significantly increased incidence of transitional cell hyperplasia in the renal pelvis compared to controls. Hepatocellular megalocytosis/ syncytium formation with fibroplasia radiating between hepatic cords, and occasional increased hepatocellular intracytoplasmic basophilia was only observed in the main study high­ dose female group (15/ 68 animals examined at that site) and may have been related to induction of hepatocellular protein synthesis. The significance of this finding is unknown but considered adverse. The lowest­ observed­ adverse­ effect level (LOAEL) for Linuron in ChR­ CD® rats is 125 ppm (5.11 mg/ kg/ day for males and 7.75 mg/ kg/ day for females), based on decreased body weight gains in both sexes, microscopic observations consistent with hemolysis (hemosiderin in Kupffer cells and increased hemosiderosis in bone marrow, spleen, and/ or mesenteric lymph nodes), and increased incidences of microscopic changes in the epididymides (perivasculitis/ vasculitis) and renal pelvis (transitional cell hyperplasia and mineralization/ calculi) of males and kidneys (calculi in renal tubules) of females. The corresponding no­ observed­ adverse­ effect level is 50 ppm (2.09 mg/ kg/ day for males and 3.13 mg/ kg/ day for females). 13 There was a treatment­ related increase in the incidence of testicular interstitial adenomas at the 125 and 625 ppm treatment levels (5.7, 27.5, and 53.6% for control, mid­, and high­ dose males, respectively; p< 0.01). Common neoplasms, included pituitary adenomas of the pars anterior in both male and female rats and mammary fibroadenomas in female rats. Decreased incidences of both these tumor types were noted in the high­ dose female group. Dosing was considered adequate based on the decreases in body weight and body weight gain of high­ dose females. This chronic toxicity/ oncogenicity study in the rat is Acceptable/ Guideline and does satisfy the guideline requirement for a chronic toxicity/ oncogenicity oral study [OPPTS 870.4300 (§ 83­ 5)] in the rat; however, it must be noted that results from concentration and stability analyses indicate potential variation between nominal and actual diet concentrations which make the exact doses to the animals questionable. Discussion of Tumor Data: In a chronic toxicity/ oncogenicity study, INZ­ 326 (linuron; 96.9­ 97.2% a. i.) was administered in the diet to groups of 70 ChR­ CD' rats/ sex/ dose at concentrations of 0, 50, 125, and 625 ppm (0, 2.09, 5.11, and 27.1 mg/ kg/ day for males and 0, 3.13, 7.75, and 48.3 mg/ kg/ day for females) for up to 2 years. There was a treatment­ related increase in the incidence of testicular interstitial adenomas at the 125 and 625 ppm treatment levels (5.7, 27.5, and 53.6% for control, mid­, and high­ dose males, respectively; p< 0.01). Common neoplasms, included pituitary adenomas of the pars anterior in both male and female rats and mammary fibroadenomas in female rats. Decreased incidences of both these tumor types were noted in the high­ dose female group. Adequacy of Dose Levels: Dosing was considered adequate based on the decreases in body weight and body weight gain of high­ dose females. 3.2 Carcinogenicity Study in Mice MRID No. 00124195 Executive Summary: In an oncogenicity study (MRID 00124195), INZ­ 326 (97.0% a. i., Haskell Laboratory identification no. 10720) was administered to groups of 80 male and 80 female Charles River CD®­ 1 mice in the diet at concentrations of 0, 50, 150, or 1500 ppm. The test diets were given for 24 months. The concentrations of 50, 150, and 1500 ppm resulted in mean daily compound intakes for males of 8, 23, and 261 mg/ kg/ day; and for females of 12, 35, and 455 mg/ kg/ day, respectively, calculated from food intake and body weight measurements. No significant treatment­ related effects were seen in clinical signs or survival. Body weights were consistently and significantly lower in males and females at 1500 ppm than in the control groups throughout the study. At 52 weeks, the group mean body weights and weight 14 gains of high­ dose males were 8% and 15% lower than the controls, respectively, and highdose females were decreased by 11% and 21%. At 104 weeks, the body weights and weight gains of high­ dose males were 10% and 20% less than the controls, and in high­ dose females were 8% and 14% less than the controls, respectively. The overall food intake for high­ dose males was decreased by about 14% and by 10% for high­ dose females compared to the controls. Food efficiency for the 2­ year study was not significantly affected in treated animals. Increases of 9­ 18% in group mean erythrocyte cell volume and mean cell hemoglobin were seen in males and females after 6 months of treatment at 1500 ppm. Erythrocyte counts were decreased by 9% and 14% in high­ dose males and females, respectively, compared to the controls at 6 months. These hematology values returned to near control levels later in the study. A significant increased incidence of hemosiderin deposits in the spleens of both sexes at 1500 ppm is suggestive of a compensated hemolytic anemia in high­ dose animals. Methemoglobin levels were increased in high­ dose females by 117% compared to the control group, and were increased in high­ dose males by 613% compared to the 50 ppm group (the male control value was not available). Differential white cell counts were within normal parameters for both sexes at all doses. The absolute and relative (to body) liver weights were increased by 20% and 24%, respectively in high­ dose males and by 65% in high dose females compared to the controls. Microscopic evidence of liver toxicity at 1500 ppm included increased incidences of focal hepatocellular cytoplasmic alteration, focal centrilobular peliosis, and centrilobular hepatocytomegaly in both sexes, and increased incidence of hepatocellular cytoplasmic vacuolation in females. The LOAEL for INZ­ 326 in mice is 1500 ppm in the diet for males (261 mg/ kg/ day) and females (455 mg/ kg/ day), based on microscopic liver changes, methemoglobinemia, and decreased body weight and weight gain in both sexes. The NOAEL was 150 ppm for males (23 mg/ kg/ day) and females (35 mg/ kg/ day). Treatment of up to 104 weeks with 1500 ppm INZ­ 326 resulted in a significant increase in the incidence of hepatocellular adenomas (control, 6%; 1500 ppm, 25%, p < 0.05) in female Charles River CD®­ 1 mice under the conditions of this study. Dosing was considered adequate based on the liver changes, methemoglobinemia, and decreased body weights. This oncogenicity study in the mouse is Acceptable (Guideline) and does satisfy the guideline requirement for an oncogenicity study [OPPTS 870.4200 (§ 83­ 2)] in mice. There were a number of deficiencies in this study, but none that would alter the conclusions reached through the available data. Discussion of Tumor Data: Treatment of up to 104 weeks with 1500 ppm INZ­ 326 resulted in a significant increase in the incidence of hepatocellular adenomas (control, 6%; 1500 ppm, 25%, p < 0.05) in female Charles River CD®­ 1 mice under the conditions of this study. 15 Adequacy of the Dose Levels: Tested: Dosing was considered adequate based on the decreases in body weights, body weight gains and other systemic effects (microscopic liver changes, methemoglobinemia) in high­ dose males (261 mg/ kg/ day) and females (455 mg/ kg/ day). 3.3 Special Oncogenicity Study ­ Aged Male Rats MRID No.: 45506501 Executive Summary: A special study (MRID 45506501) was conducted to determine whether linuron (94.5% a. i.) administered in the diet to aged male Crl: CD( SD) BR rats would induce testicular interstitial cell (Leydig cell) hyperplasia and adenomas. Two groups of 25 rats each were given 625 ppm linuron beginning at 12 or 18 months of age and continuing for 6 and 12 months; terminal sacrifice was carried out at 24 months of age. Another group of 25 rats was given basal diet and served as controls. Compound intake for both treated groups was 22­ 23 mg/ kg/ day for the treatment interval. Treatment­ related clinical signs of toxicity were limited to swollen testes observed in 2, 4, and 5 rats in the control, 6­, and 12­ month groups. A total of 6, 4, and 4 rats, respectively, were found dead or were sacrificed in extremis prior to scheduled termination; further details were not included. Body weights of both treated groups were significantly reduced as compared with the control group within two weeks after the initiation of feeding the test article. Final body weights for the control, 6­, and 12­ month groups were 848.5, 670.1, and 668.5 g, respectively (additional data not given in original DER). Weight gains during the treatment intervals were significantly (p # 0.05) less than the controls with a weight loss for animals treated for 6 months (­ 107.8 g vs 45.6 g for control) and a weight gain 2.1% of the control level by the animals treated for 12 months. Food consumption and food efficiency values were slightly reduced for both treated groups as compared with the controls throughout the treatment intervals, but statistical significance was not attained. At necropsy discoloration of the testes was observed in 2/ 25, 4/ 25, and 6/ 25 rats in the control, 6­ and 12­ month groups, respectively. However the observation did not correlate with either interstitial cell adenoma or hyperplasia. For rats sacrificed at study termination, a dose­ related increases in the incidence of testicular adenoma were observed. The incidences in the control, 6­, and 12­ month groups were 0/ 19, 2/ 21, and 6/ 21 (p # 0.05), respectively. In addition, testicular hyperplasia was observed in 6/ 19, 7/ 21, and 14/ 21 (p # 0.05) rats, respectively. No increased incidences of hyperplasia or adenoma in the adrenal cortex, adrenal medulla, or the pituitary gland were observed in the treated groups as compared with the control group. 16 In conclusion, linuron induced hyperplasia and adenomas of the testes in aged rats. In addition, life­ time feeding was not necessary to induce oncogenic responses in this tissue, in fact linuron may be more potent as an oncogen than previously estimated from the two­ year study. This study is classified as Acceptable/ Nonguideline as a special feeding study in aged rats. Discussion of Tumor Data: A special study was conducted to determine whether linuron (94.5% a. i.) administered in the diet to aged male Crl: CD( SD) BR rats would induce testicular interstitial cell (Leydig cell) hyperplasia and adenomas. Two groups of 25 rats each were given 625 ppm linuron beginning at 12 or 18 months of age and continuing until sacrifice at 24 months of age; another group of 25 rats was given basal diet and served as controls. Compound intake for both treated groups was 22­ 23 mg/ kg/ day for the treatment interval. For rats sacrificed at study termination, a dose­ related increased incidence of testicular adenoma was observed. The incidence rates in the control, 6­, and 12­ month groups were 0/ 19, 2/ 21, and 6/ 21 (p # 0.05), respectively. In addition, testicular hyperplasia was observed in 6/ 19, 7/ 21, and 14/ 21 (p # 0.05) rats, respectively. No increased incidences of hyperplasia or adenoma in the adrenal cortex, adrenal medulla, or the pituitary gland were observed in the treated groups as compared with the control group. In conclusion, linuron induced hyperplasia and adenomas of the testes in aged rats. In addition, life­ time feeding was not necessary to induce oncogenic responses in this tissue, in fact, linuron may be a more potent oncogen than previously estimated from the 2 year study. Adequacy of Dose Levels: Dose levels were the same as the previously conducted oncogenicity study in the rat. 3.4 Classification of Carcinogenic Potential Linuron was placed in special review for carcinogenic effects in 1982. Linuron was later classified as a group C carcinogen with a Q1* of 2 x 10 ­5 on the basis of a dose­ related increase in interstitial cell hyperplasia and adenomas in a two­ year rat feeding study (00029680) and hepatocellular tumors that appeared in low­ dose male and high­ dose female mice in a two­ year feeding study (00124195). Subsequent review by the HED peer review committee and the Science Advisory Panel resulted in the removal of the Q1* for quantification of risk. At present, Linuron is classified as a Group C carcinogen requiring no quantification of human cancer risk [Federal Register 54( 17): 4072]. 4 MUTAGENICITY 4.1 Gene Mutations 4.1.1 Salmonella typhimurium/ Escherichia coli reverse gene mutation assay MRID No.: 00131738 17 Executive Summary: In a reverse gene mutation assay in bacteria, S. typhimurium strains TA98, TA100, TA1535, and TA1537 were exposed to Linuron (95­ 97%) in dimethylsulfoxide (DMSO) at concentrations of 0.5, 0.75, 1.0, 2.5, and 5.0 : g/ plate in the absence of mammalian metabolic activation (S9­ mix) and 1, 5, 10, 50, and 100 : g/ plate in the presence of S­ 9 mix. Duplicate plates were utilized for each test concentration, and two independent assays were performed. The S9­ fraction was obtained from Aroclor 1254 induced Charles River CD rat liver. Linuron was cytotoxic at $ 5 : g/ plate without S­ 9 mix; and was cytotoxic at $ 50 : g/ plate with S­ 9 mix. No treatment­ related increase in mutant frequency was noted in any strain tested with or without exogenous metabolic activation. The solvent (DMSO) and positive control (N­ methyl­ N'­ nitro­ N­ nitrosoguanidine, 2­ nitrofluorene, 9­ aminoacridine, and 2­ aminoacridene) values were appropriate in the respective strains. There was no evidence of induced mutant colonies over background with or without S9 activation. This study is classified as Acceptable/ Guideline. It satisfies the requirements for FIFRA Test Guideline [OPPTS 870.5100 (§ 84­ 2)] for in vitro mutagenicity (bacterial reverse gene mutation) data. 4.1.2 Chinese Hamster Ovary (CHO)/ HGPRT cell forward gene mutation assay MRID No.: 00137152 Executive Summary: In a mammalian cell gene mutation assay in vitro, triplicate (in the absence of activation) or duplicate (in the presence of activation) cultures of Chinese hamster ovary (CHO) CHO­ K1­ BH4 cells were exposed to Linuron (Lot No. 1N2­ 326­ 141, 94.5% a. i.) in F12 medium at concentrations of 0.05, 0.25, 0.35, 0.40, 0.45, and 0.50 mM in the absence of mammalian metabolic activation (S9­ mix), and at 0.25, 0.50, 0.75, 0.90, and 1.0 mM in the presence of Charles River S9­ mix. The S9­ fraction was obtained from Aroclor 1254­ induced 8 to 9 week­ old male Charles River CD rats. Linuron was tested up to concentrations limited by cytotoxicity. Cytotoxicity was observed at 0.45 and 0.5 mM under nonactivated conditions and at 0.75 mM and above with 0.5 mg S9 protein/ mL and at 1.0mM and above with 1.0 mg S9 protein/ mL. (Percentage cell survival were not provided in the DER). There was no increase in mutant frequency in cells treated with linuron in either the presence or absence of metabolic activation. The positive (ethyl methane sulfonate (EMS) without S9­ mix and dimethylbenzanthracene with S9­ mix) and solvent (DMSO) controls responded appropriately. No evidence of an increased mutant frequency was observed in the presence or absence of metabolic activation. 18 This study is classified as Acceptable/ Guideline. It satisfies the requirements for FIFRA Test Guideline [OPPTS 870.5300 (§ 84­ 2)] for in vitro mutagenicity (mammalian forward gene mutation) data. 4.2 Chromosome Aberrations 4.2.1 In vivo bone marrow cytogenetic assay MRID No.: 00137153 Executive Summary: In a mammalian cell cytogenetics chromosomal aberration assay in bone marrow cells of Sprague­ Dawley rats, 5 rats per sex per harvest time were administered Linuron (94.5%, lot number not given) by single gavage at doses of 0, 100, 300, or 1000 mg/ kg. Bone marrow cells were harvested 6­, 12­, 24­, or 48­ hours after test compound administration and 48 hours after the positive control dose. The vehicle was corn oil (20 mL/ kg) and the positive control was a single 40 mg/ kg dose of cyclophosphamide. One high­ dose rat in the 24­ hour group was found dead and 8 of 10 high­ dose rats in the 48­ hour group died prior to sacrifice on day 2. Low­ and mid­ dose animals exhibited slight depression, ataxia, and/ or prostration. Treated animals also had decreased body weights compared to controls. There was no significant increase in the frequency of aberrations in bone marrow cells of treated animals compared to controls at any sampling time. Values in treated animals ranged from 0.3­ 0.8% aberrant cells/ group; the positive control group had 19.6% aberrant cells, indicating that this control responded appropriately. There was no change in mitotic index of dosed groups compared to controls. There is no evidence that Linuron induced chromosomal aberrations in bone marrow cells of rats over background levels. This study is classified as Acceptable/ Guideline. It satisfies the requirements for FIFRA Test Guideline OPPTS [870.5385 (§ 84­ 2)] for in vivo cytogenetic mutagenicity data. 4.3 Other Mutagenic Mechanisms 4.3.1 Unscheduled DNA synthesis (UDS) in WI­ 38 human fibroblasts assay MRID No.: 00132583 Executive Summary: In an unscheduled DNA synthesis assay, primary rat hepatocyte cultures were exposed to Linuron (94.5% a. i. in dimethylsulfoxide; Lot No. T80311­ 81) in Williams' Medium E (WME) at concentrations of 0.00001, 0.0001, 0.001, 0.01, 0.1, 1.0, 10, and 50.0 mM (trial 1) or 0.01, 0.1, 1.0, 10, and 50.0 mM (trial 2) for 18 hours. Linuron was cytotoxic in one of 2 cultures at 1.0 mM in trial 1; no other cytotoxicity data 19 were provided. The mean net nuclear grain counts were calculated from 25 randomly selected nuclei per slide. There was no increase in mean net nuclear grain counts in treated cells compared to the solvent control, indicating no induction of UDS activity. The solvent (DMSO) and positive control (1.0 mM dimethylbenzanthracene) values were appropriate. There was no evidence that unscheduled DNA synthesis, as determined by radioactive tracer procedures [nuclear silver grain counts] was induced. This study is classified as Acceptable/ Guideline. It satisfies the requirements for FIFRA Test Guideline [OPPTS 870.5550 (§ 84­ 2)] for other genotoxic mutagenicity data. 4.4 Conclusions: Linuron was not mutagenic in bacteria or in cultured mammalian cells. There was also no indication of a clastogenic effect up to toxic doses in vivo. The submitted test battery satisfies the Pre­ 1991 mutagenicity initial testing battery guidelines. No further testing is required at this time. 5 FQPA CONSIDERATIONS 5.1 Adequacy of the Data Base The toxicology data base is complete but is inadequate for an FQPA assessment. The required developmental toxicity studies in the rat and rabbit and reproduction studies in the rat meet guideline requirements. 5.2 Neurotoxicity Data No acute or subchronic neurotoxicity studies on Linuron are available. Evaluation of subchronic, chronic and reproduction toxicity, did not indicate any treatment­ related effects on the central or peripheral nervous system of mice, rats, or rabbits. No changes in clinical signs, brain weights, gross necropsy results or histopathological results suggested any part of the nervous system as a target organ. 20 5.3 Developmental Toxicity 5.3.1 Prenatal Developmental Study ­ Rat MRID No: 00018167 Executive Summary: In a developmental toxicity study, 27 presumed pregnant Crl: CD rats per group were administered 0, 50, 125, or 625 ppm of linuron (97% a. i.; Lot No. INZ­ 326­ 118) in the diet on gestation days (GD) 6­ 15, inclusive. Average doses to the treated dams were 5.0, 12, and 50 mg/ kg/ day, respectively. The day evidence of mating was found was designated GD 1. Maternal body weights and food consumption were recorded on GD 6, 10, 16, and 21. On GD 21, all surviving dams were sacrificed and all fetuses were weighed and examined for external malformations/ variations. Crown­ rump length was measured on each fetus. Approximately one­ half of the fetuses in each litter were fixed in Bouin's solution for visceral examination and the remaining one­ half were processed for skeletal examination. All animals survived to scheduled termination without the appearance of any treatmentrelated clinical signs of toxicity. Gross necropsy was unremarkable. No treatmentrelated clinical signs of toxicity were observed. Body weight gains and food consumption by the low­ and mid­ dose groups were similar to the controls throughout the study. Body weights of the high­ dose group were significantly (p # 0.05) less than the control group on GD 10, 16, and 21. Food consumption by the high­ dose group was significantly (p # 0.05) less than that of the controls for the intervals of GD 6­ 10 and 10­ 16. The maternal toxicity LOAEL is 625 ppm (50 mg/ kg/ day) based on reduced body weight gain and food consumption. The maternal toxicity NOAEL is 125 ppm (12 mg/ kg/ day). No dose­ or treatment­ related effects were observed on fetal sex ratios, numbers of corpora lutea/ dam, implantations/ dam, live or dead fetuses/ dam, fetal body weights, or crown­ rump length. In the control, low­, mid­, and high­ dose groups post­ implantation loss was 5.8, 3.5, 4.4, and 14.0%, respectively, and the number of resorptions per litter with resorption was 1.6, 1.6, 1.2, and 2.1, respectively. No treatment­ related external or visceral malformations/ variations were noted. In the high­ dose group bipartite thoracic vetebral centra was observed in 7 fetuses from 7 litters and unapposed sternebrae were observed in 3 fetuses from 3 litters. These anomalies were not found in the control group and were considered indicative of developmental delays. The developmental toxicity LOAEL is 625 ppm (50 mg/ kg/ day) based on increases in post­ implantation loss and in litter/ fetal resorptions. The developmental toxicity NOAEL is 125 ppm (12 mg/ kg/ day). 21 This study is classified as Acceptable/ Guideline and does satisfy the guidelines for a developmental toxicity study [OPPTS 870.3700 (83­ 3a)] in rats. Deficiencies included no information on dietary formulation preparation or analyses, the treatment period should have been GD 7­ 16, body weight on GD 0 were not collected, fetal anomalies were not classified as malformations or variations, and fetuses were not individually identified. 5.3.2 Developmental Toxicity Study in the Rabbit MRID Nos: 00153867 and 40437201 Executive Summary: In a developmental toxicity study, 25 presumed pregnant New Zealand white rabbits per group were administered 0, 5, 25, or 100 mg/ kg/ day of linuron (96.2% a. i.) by gavage on gestation days (GD) 7­ 19, inclusive. Doses were chosen based on the results of a range­ finding study. The vehicle was 0.5% hydroxypropylmethylcellulose On GD 29, all surviving does were sacrificed and the livers weighed. All fetuses were weighed and examined for external and visceral malformations/ variations including free­ hand sectioning of the brain. All fetuses were eviscerated and processed for skeletal examination. No dose­ or treatment­ related clinical signs of toxicity, maternal deaths, or necropsy findings were observed in any group. Absolute body weights and food consumption for the low­ and mid­ dose groups and body weight gain by the low­ dose group were not affected by treatment. Body weight of the high­ dose group was significantly (p # 0.05) less than that of the controls on GD 19. Body weight gains during GD 13­ 16 were slightly less for the middose group (50%, n. s.) and significantly less for the high­ dose group (­ 0.01 g vs 0.08 g for the controls; p # 0.05) as compared with the controls. Similarly, during GD 16­ 20 body weight gains were slightly less for the mid­ dose group and significantly (p # 0.01) less for the high­ dose group (0.00 g for mid­ dose and ­0.12 g for high­ dose vs 0.02 g for the controls) as compared with the controls. Both mid­ and high­ dose groups had significantly (p # 0.05) greater body weight gains as compared with the controls during GD 20­ 24. Food consumption by the high­ dose group was significantly (p # 0.05) less than that of the controls on GD 13­ 16 and 16­ 20. In the high­ dose group, absolute and relative liver weights were increased to 129% (p # 0.01) and 135% (n. s.), respectively of controls. The maternal toxicity LOAEL was established at 25 mg/ kg/ day based on reduced body weight gain. The maternal toxicity NOAEL was established at 5 mg/ kg/ day. The number of fetuses( litters) available for evaluation in the control, low­, mid­, and high­ dose groups was 135( 20), 135( 20), 121( 17), and 79( 13), respectively. 22 Five high­ dose does aborted between days 20­ 25 compared with one control doe on GD 22. The mean number and percentage of resorptions and number of dead fetuses were similar between the treated and control groups. In the high­ dose group, slight (n. s.) decreases in the mean number of live fetuses/ litter (6.1 vs 6.8 for controls) and mean fetal body weight (41.99 g vs 45.8 g for controls) were observed. No treatment­ related external or visceral fetal malformations/ variations were noted. In the control, low­, mid­, and high­ dose groups, skull alterations (irregularly shaped fontanelle, hole in parietals, parietals contain intraparietals, and unossified) were observed in 1( 1), 9( 5), 5( 3), and 19( 6) fetuses( litters), respectively. The litter incidence for the high­ dose group was significantly (p # 0.05) greater than that of the control group. It should be noted that 6 fetuses from 5 low­ dose litters also had a variety of external malformations of the head and body. The developmental toxicity LOAEL was established at 100 mg/ kg/ day based on alterations of the bones of the skull. The developmental toxicity NOAEL was established at 25 mg/ kg/ day. This study is classified as Acceptable/ Guideline and does satisfy the guidelines for a developmental toxicity study [OPPTS 870.3700 (83­ 3b)] in rabbits. 5.4 Reproductive Toxicity 5.4.1 Three­ Generation Reproduction ­ Rat MRID No.: 00146071 & 00155168 Executive Summary: In a three­ generation reproduction study, Linuron (94.5% a. i.) was administered to groups of 20 male and 20 female Crl: CD® rats in the diet at concentrations of 0, 25, 125, or 625 ppm. Two litters were produced by the F0 and F1 generations and one litter was produced by the F2 generation. Average premating doses were 0, 2, 9, and 44 mg/ kg/ day, respectively, for F0 males; 0, 2, 10, and 50 mg/ kg/ day, respectively, for F0 females; 0, 2, 9, and 50 mg/ kg/ day, respectively, for F1 males; 0, 2, 11, and 59 mg/ kg/ day, respectively, for F1 females; 0, 2, 9, and 48 mg/ kg/ day, respectively, for F2 males; and 0, 2, 11, and 67 mg/ kg/ day, respectively, for F2 females. F1 and F2 adults were chosen from the F1b and F2b litters, respectively. F0, F1, and F2 male and female parental animals were administered test or control diet for at least 90 days prior to mating, throughout mating, gestation, and lactation, and until necropsy. At weaning 10 F2b pups/ sex/ group were subjected to gross necropsy with microscopic examination of selected tissues. Following the reproductive toxicity evaluations, F1 and F2 adults were maintained on their respective diets, for up to a total of 22 months on study, for hematological evaluations (MRID 00155168). Premature deaths of several adults in each generation were considered incidental to 23 treatment. No treatment­ related clinical signs of toxicity were observed in males or females during premating in any generation. Necropsy findings were not reported for adults. No effects on body weights or body weight gains were seen in the low­ dose groups of any generation; food consumption and food efficiency were not affected by treatment. Body weights of the high­ dose parental animals were significantly (p # 0.05) less than those of the controls beginning on day 7 for the F0 adults and throughout premating for the F1 and F2 adults. Compared with their control levels, body weights for the high­ dose males and females were 83­ 90% and 88­ 93%, respectively, for the F0 adults, 77­ 81% and 74­ 87%, respectively, for the F1 adults, and 72­ 79% and 74­ 81%, respectively, for the F2 adults. Premating weight gains for the high­ dose males and females were significantly (p # 0.05) less than those of the controls in all generations. Body weights of the mid­ dose males were less than those of the controls during each generation, but statistical significance was reached only occasionally. Body weights of the mid­ dose females from all generations were 88­ 94% of the control levels with statistical significance (p # 0.05) attained at most time points. Lower body weights of the mid­ and/ or high­ dose dams after weaning of their litters were considered a continuation of the premating effects on body weights. Hematology results for the F1 rats were inconclusive. No treatment­ related hematological effects were noted in F2 males after continuous feeding for 20 months. However, for F2 females a mild anemia was observed in the mid­ and high­ dose groups at 20 and 22 months. In mid­ and high­ dose females, RBC counts were decreased to 90­ 91% of the controls, hemoglobin was decreased to 89­ 93% of controls, and the percent of reticuloytes was increased to 147­ 213% of the control levels. Although statistical significance was not attained for all endpoints at both sampling intervals, the changes in red cell parameters are considered to be biologically significant. Treatment­ related lesions observed in the liver of high­ dose F2b weanlings are considered systemic toxicity. In the control, low­, mid­, and high­ dose groups, the incidence (average severity) of hepatocellular atrophy was 1/ 10 (2.0), 0/ 10 (0), 2/ 10 (1.5), and 8/ 10 (2.1), respectively, for males and 2/ 10 (3.0), 1/ 10 (3.0), 2/ 10 (2.0), and 10/ 10 (2.5), respectively, for females. The incidence and severity of decreased cytoplasmic vesiculation was the same as that of hepatocellular atrophy for all groups except the high­ dose males in which 10/ 10 were affected with an average severity score of 2.0. The LOAEL for systemic toxicity was established at 125 ppm (average premating dose 9 mg/ kg/ day, males and 10 mg/ kg/ day, females) based on reduced body weights of males and females and anemia in females. The systemic toxicity NOAEL is 25 ppm (premating dose 2 mg/ kg/ day in males and females). Fertility, pup survival, and pup body weights were not affected in the low­ or mid­ dose 24 groups in any generation. In the high­ dose groups, fertility was decreased with each successive litter and generation. The fertility indices for production of the F1a, F1b, F2a, F2b, and F3 litters were 100, 89.5, 63.2, 61.1, and 52.6%, respectively. Mean live litter size at birth and pup viability during lactation days 0­ 4 were significantly (p # 0.05) or slightly reduced for all litters produced by the high­ dose groups. Both of these parameters generally declined with each successive litter and generation. Mean live litter sizes were 6.2­ 9.3 pups for the high­ dose groups compared with 11.7­ 13.3 pups for the control groups. Viability indices for lactation days 0­ 4 were 58.8­ 92.0% for the highdose litters compared with 92.1­ 100% for the control litters. The reproductive toxicity LOAEL was established at 625 ppm (premating dose 44 mg/ kg/ day in males and 48 mg/ kg/ day in females) based on reduced fertility. The reproductive toxicity NOAEL is 125 ppm (average premating dose 9 mg/ kg/ day in males and 10 mg/ kg/ day in females). Body weights of the high­ dose pups from all generations were consistently reduced throughout lactation as compared to those of the controls with statistical significance (p # 0.05) attained at most time points. Body weights of the high­ dose pups from both litters of the F1 and F2 generations were approximately 82­ 94% of the control levels one day after birth and declined to approximately 66­ 80% of the control levels at weaning. In contrast body weights of the high­ dose F3 pups were 84­ 89% of the controls throughout lactation. Differences in absolute and/ or relative organ weights in high­ dose F2b weanlings were considered to be due to lower final body weights. The offspring toxicity LOAEL was established at 625 ppm (premating dose 44 mg/ kg/ day, males and 48 mg/ kg/ day, females) based on decreased pup survival, and lower pup body weights. The offspring toxicity NOAEL is 125 ppm (average premating dose 9 mg/ kg/ day in males and 10 mg/ kg/ day in females). This study is classified as Acceptable/ Guideline and satisfies the requirements for a reproduction study (870.3800 [83­ 4]) in rats. 5.4.2 Two­ Generation Reproduction ­ Rat MRID No: 41463401 Executive Summary: In a two­ generation reproduction study, linuron (96.2% a. i.) was administered to groups of 30 male and 30 female Crl: CDBR rats in the diet at concentrations of 0, 12.5, 100, or 625 ppm. One litter was produced by each generation. Average premating doses for the treated F0 groups were 0.74, 5.8, and 36 mg/ kg/ day, respectively, for males and 0.92, 7.3, and 45.1 mg/ kg/ day, respectively, for females. Average premating doses for the treated F1 groups were 0.95, 7.77, and 54.0 mg/ kg/ day, respectively, for males and 1.12, 9.24, and 63.0 mg/ kg/ day, respectively, for females. F0 and F1 parental animals were administered test or control diet for 72 or 75 days, respectively, prior to mating and throughout mating, gestation, and lactation, and until 25 necropsy. No treatment­ related clinical signs of toxicity or mortalities were observed in the adult animals of either generation. Body weights, body weight gains, and food consumption were significantly (p # 0.05) less than those of the controls beginning on day 7 for the high­ dose F0 animals and throughout premating for the mid­ and high­ dose F1 animals. At the end of premating, body weights of the high­ dose F0 males and females were 81% and 86%, respectively, of the controls with overall weight gains 59% and 55%, respectively, of the control values. For the high­ dose F1 males and females final premating body weights were 76% and 75%, respectively, with weight gains 77% and 77%, respectively, of the control levels. Mean daily food consumption levels for the high­ dose groups during the premating interval were 80­ 85% of the control levels. Absolute body weights of the mid­ dose F0 males were occasionally significantly (p # 0.05) less than the controls with premating weight gains and food consumption 88% and 94% (both, p # 0.05), respectively, of the control levels. For the mid­ dose F1 males and females, final premating body weights, body weight gains, and food consumption were 92­ 94% of the control levels. For the mid­ and high­ dose dams of both generations, lower body weights during gestation and lactation were considered a continuation of premating effects. No treatment­ related lesions were noted at necropsy of the F0 males or females. In highdose F1 males, gross lesions of the testes included reduced in size (9/ 30), abnormally large (3/ 30), soft (5/ 30), small epididymides (8/ 30), and unspecified deformities of the epididymides (5/ 30); these were noted as significant incidences, but control rates were not given in the original DER. Microscopically, increased incidences (p # 0.05) of testicular and epididymal lesions were found in high­ dose F1 males as compared with the controls: atrophy (14/ 30), fibrosis (8/ 30), and hyperplasia (7/ 30) in the testes and arteritis (6/ 30), inflammation (5/ 30), and oligospermia (12/ 30) in the epididymides. Only one incidence each of atrophy and oligospermia were observed in control animals. Absolute testes weights of the high­ dose F1 males were significantly (p # 0.05; 80% of control) less than the controls. In high­ dose F1 females, gross findings (n. s.) included cystic ovaries (4/ 30), dilatation (3/ 30), and fluid filled uterine horns (2/ 30), none of which were observed in control animals. In addition, lesions of the eye were noted in high­ dose F1 males and females and were reviewed in MRID 41864701. A significant (p # 0.05) increase was seen in the number of high­ dose F1 males with any type of corneal or conjunctival change (14/ 30 vs 4/ 30 controls). The lesions included corneal degeneration/ basophilia and conjunctival inflammation/ basophilia. Degeneration of the lens was observed in 3/ 30 high­ dose males and 3/ 29 high­ dose females compared with only 1/ 30 control male. However, a clear treatment­ related effect in females was not considered to be definitive. The systemic toxicity LOAEL was established at 100 ppm (average premating doses 5.8­ 9.24 mg/ kg/ day) based on reduced body weight gains in males and females 26 during both generations. The systemic toxicity NOAEL was established at 12.5 ppm (average premating doses 0.74­ 1.12 mg/ kg/ day). No treatment­ related adverse effects were found on the reproductive performance of either generation. For the control, low­, mid­, and high­ dose group, pup viability for lactation days 0­ 4 was 99.4, 98.0, 99.8, and 91.7% (p # 0.05), respectively, for the F1 generation and 96.8, 92.7, 99.5, and 76.2% (p # 0.05), respectively, for the F2 generation. The mean number of pups per litter in the high­ dose F2 group was significantly (p # 0.05) less than the control throughout lactation. The number of litters with pups showing clinical signs was significantly (p # 0.05) increased in both generations. The reproductive toxicity NOAEL was greater than or equal to 625 ppm (average premating doses 36­ 63.0 mg/ kg/ day) and the reproductive toxicity LOAEL was not established. Body weights of the mid­ and high­ dose F1 male and female pups and of the high­ dose F2 male and female pups were significantly (p # 0.05) less than those of the controls throughout lactation LOAEL for offspring toxicity was established at 100 ppm (average premating doses 5.8­ 9.24 mg/ kg/ day) based on reduced F1 pup body weights. The offspring toxicity NOAEL was established at 12.5 ppm (average premating doses 0.74­ 1.12 mg/ kg/ day). This study is classified as Acceptable/ Guideline and satisfies the guideline requirements for a reproductive toxicity study [OPPTS 870.3800 (83­ 4)] in rats. 5.5 Special Studies 5.5.1 Biochemical and Histopathological Effects in Rats MRID No: 00164093 Executive Summary: A special study was conducted to determine the biochemical and histopathological effects under a variety of conditions of linuron (94.5% a. i.) administration to Crl: CD® BR rats. The rats utilized for various parts of this study were young adult males approximately 22 days old (young), retired breeder males approximately 11 months old (old), and male and female F1b and F2b rats from a multigeneration study (MRID 41463401) maintained on diets of 0, 12.5, 100, or 625 ppm (0, 0.75, 4.1, and 22 mg/ kg/ day, respectively, for males and 0, 1.1, 6.1, and 37 mg/ kg/ day, respectively, for females). Additionally, Leydig cell enzyme analyses were conducted in vitro. The activities of five testicular steroidogenic enzymes were assayed in vitro using horse 27 testicular microsomal preparations in the presence of 0, 0.5, 5, 50, 500, or 5000 : M linuron or linuron metabolites. Enzyme activities measured included aromatase, 17­ 20 desmolase (desmolase), 3­ $ ­hydroxysteriod dehydrogenase/ isomerase (isomerase), 17­ hydroxylase (hydroxylase), and 17­ ketosteriod reductase (reductase). Linuron concentrations of 500 and 5000 : M resulted in significantly decreased aromatase and desmolase and increased reductase activities. At 50 : M the activities of aromatase, desmolase, isomerase, and hydroxylase were decreased by 10­ 20% and reductase was increased by 20% as compared with the controls. Effects of linuron metabolites on enzyme activities were highly variable and generally only seen at 5000 : M. The testosterone metabolic clearance rate was measured in young male rats. Groups of 5 animals were administered 0 or 200 mg/ kg/ day for eight days, castrated, and then infused with testosterone at 3 or 6 : g/ hour. Blood samples were taken every 30 minutes for 180 minutes after the start of infusion. No differences between the treated and control groups were noted at the lower infusion rate. At the higher infusion rate, the mean plateau concentrations (60­ 180 minutes) in the control and treated rats were 769± 344 and 605± 67.4 : g/ dL, respectively, resulting in calculated metabolic clearance rates of 780 and 992 mL/ h, respectively. Due to the large variability between individual animals it was concluded that linuron does not affect testosterone clearance in young, castrated rats. Two trials evaluated the response of Leydig cells to luteinizing hormone (LH). In trial 1, the groups consisted of five young or five old males treated with 0 or 200 mg/ kg/ day for three days, and five 0­ ppm and five 625­ ppm F2b males which were approximately 11 months old. In trial 2, the groups consisted of five young or five old males treated with 0 or 200 mg/ kg/ day for seven days, and five each of the 0, 12.5, 100, and 625 ppm F2b males which were approximately 19 months old. Leydig cells were isolated from the testes and incubated with up to 1000 ng LH/ tube. Results from trial 1 showed no differences in the response between the treated and control young rats. However in old rats, Leydig cells from the treated animals were less responsive than the controls both in maximum response and potency. In contrast, Leydig cells from the chronically treated F2b males were significantly more responsive to LH stimulation as compared with their controls. In trial 2, Leydig cells from treated young and old rats had decreased maximum responses and potency as compared with controls, with old rats more affected than young rats. From the chronically exposed rats, Ledig cells were moderately responsive from the control and low­ dose groups, minimally responsive from the mid­ dose group, but significantly greater in response from the high­ dose group. Taken together, the two trials were reasonably consistent with a preliminary conclusion that there are dose­ and timerelated effects of linuron upon the sensitivity of rat Leydig cells to stimulation by LH. F1b and F2b rats were sacrificed at two years of age for histopathological evaluation of selected tissues. The number of high­ dose males of both generations with small or discolored testes was increased as compared with the controls (stated in text of DER; incidence rates not readable). No other gross observations were noted. Microscopically, mid­ and high­ dose males had increased incidences of interstitial cell adenomas and hyperplasia. Combining data from both generations, adenomas were observed in 1/ 19, 28 0/ 25, 6/ 25, and 2/ 16 animals and hyperplasia was observed in 2/ 19, 0/ 25, 7/ 25, and 3/ 19 animals from the control, low­, mid­, and high­ dose groups, respectively. The lower incidences in the high­ dose group were probably due to fewer animals available for examination. In females the combined incidence rate for cervical endometrial hyperplasia was 0/ 28, 6/ 30, 9/ 29, and 13/ 29, respectively, and of cervical cystic hyperkeratosis was 0/ 28, 1/ 30, 1/ 29, and 7/ 29, respectively. These lesions in both males and females are consistent with findings in a 2­ year chronic study. In conclusion, the biochemical and histopathological data presented in this report suggest that linuron may affect testosterone metabolism in horse testicular microsomes for a range of concentrations which overlap the dose levels given rats chronically. However, the net effect of these enzyme changes and the relevance to the rat in vivo are uncertain. Evidence in young and old rats exposed repeatedly (3­ 7x) or for 11 or 19 months suggests that Leydig cell incubates are differentially altered in their sensitivity to LH. Microscopic lesions in the testes and cervix have been confirmed in other studies. This study is classified as Acceptable/ Nonguideline as a special mechanistic study in rats. 5.5.2 Special Reproduction Study ­ Leydig Cell Tumorigenisis in Rat MRID No: 41630101 Executive Summary: A special mechanism study was conducted in male Crl: CD( SD) BR rats. Linuron (96.2% a. i) was administered at 200 mg/ kg/ day by gavage for 14 days to groups of 10 growing (32­ 33 days of age) and adult (93 days of age) rats. Additional groups of 10 rats each were used as negative control, pair­ fed control, and positive control (flutamide, 10 mg/ kg/ day). All rats were observed daily and body weights and food consumption were recorded. At termination, blood was collected for serum hormone analyses and the organs of the reproductive tract were weighed. In addition, blood was collected from the F0 and F1 males and organ weights were recorded from the F0 males from a multigeneration study (MRID 41463401). Premating doses for the multigeneration study were 0.74­ 0.95, 5.8­ 7.8, and 36­ 54 mg/ kg/ day. Finally, linuron and four of its metabolites were evaluated in vitro for their ability to compete for binding to the androgen receptor. No treatment­ related clinical signs of toxicity were observed in the growing rats, the positive controls, or the F0 and F1 rats. Adult rats treated with the test article for 14 days had significantly (p # 0.05) increased incidences of discharge and/ or stains in the perioral, perinasal, and or periocular regions (9/ 10), eye discharge (5/ 10), and weak appearance (9/ 10) as compared with both the negative and pair­ fed control groups. These signs were not observed in the control groups with the exception of one pair­ fed animal with discharge and/ or stains. Final body weights, body weight changes, and food consumption of the 14­ day treated groups, of the pair­ fed control groups, and of the mid­ and high­ dose F0 and F1 groups 29 were significantly (p # 0.05) less than that of their concurrent negative control group values. Final body weight and weight change for the 14­ day adult group were also significantly (p # 0.05) less than those of their pair­ fed control. Body weights and body weight changes were significantly (p # 0.05) reduced only in the adult positive control group as compared with their negative controls (food consumption not measured in positive controls). For growing rats, absolute and relative accessory sex organ unit, prostate, ventral prostate, and seminal vesicle weights were significantly (p # 0.05) reduced as compared with both negative and pair­ fed control groups. Absolute and relative dorsal lateral prostate and levator ani muscle weights and absolute testes weights were significantly (p # 0.05) reduced and relative testes weights were significantly increased (p # 0.05) as compared with the negative controls. Significant (p # 0.05) differences in the pair­ fed control group as compared with the negative control group included decreased absolute accessory sex organ unit, ventral prostate, dorsal lateral prostate, seminal vesicles, and levator ani muscle weights and relative testes and levator ani muscle weights. In the positive control rats, absolute and relative testes weights were not affected, but all other absolute and relative organ weights were significantly (p # 0.05) less than their negative controls. For adult rats, absolute and relative accessory sex organ unit, prostate, and ventral prostate weights were significantly (p # 0.05) reduced as compared with both negative and pair­ fed control groups. Absolute epididymides, seminal vesicle, coagulating gland, and levator ani muscle weights significantly (p # 0.05) reduced as compared with the negative controls. Significant (p # 0.05) differences in the pair­ fed control group as compared with the negative control group included decreased absolute accessory sex organ unit, coagulating gland, and levator ani muscle weights. In the positive control rats, testes weights were not affected, but all other absolute and relative organ weights were significantly (p # 0.05) or slightly (n. s.) less than their negative controls. Significant differences (p # 0.05) in organ weights for the high­ dose F0 males as compared with the controls included decreased absolute epididymides, dorsal lateral prostate, and levator ani muscle weights and increased relative testes, epididymides, and ventral prostate weights. Organ weights were unaffected in the two lower dose groups. Serum testosterone, estradiol, and luteinizing hormone levels in both growing and adult rats were similar to the control levels. However, F0 and F1 males had significantly (p # 0.05) increased levels of estradiol (155 and 115%, respectively) and luteinizing hormone (175 and 168%, respectively). In the positive control groups, testosterone, estradiol, and luteinizing hormone levels were increased (p # 0.05) 304, 123, and 304%, respectively, in growing rats and 915, 100 (n. s.), and 346%, respectively, in adult rats. Linuron and three other compounds [1­ (3,4­ dichlorophenyl)­ 3­ methoxyurea; 3,4­ dichloroanaline; 3,4­ dichlorophenylurea; and 1­( 3,4­ dichlorophenyl)­ 3­ methylurea] appeared to compete with testosterone for binding to the androgen receptor in vitro, although the results were highly variable. IC50 values for linuron and flutamide were 30 approximately 18,000 ± 3,500 and 64,000± 11,000 nM, respectively. 3,4­ dichlorophenylurea did not displace testosterone from the receptor, therefore an IC50 value could not be determined. The remaining metabolites had IC50 ranging from 110,000 to 260,000 nM. In conclusion, linuron may be a weak androgen receptor antagonist based on decreased accessory sex organ weights for growing and adult rats, increased serum luteinizing hormone levels in F0 and F1 rats, and competitive androgen receptor binding in vitro. These data support the hypothesis that rats exposed to linuron could develop interstitial hyperplasia and subsequent adenomas (Leydig cell tumors) via a mechanism of sustained hypersecretion of luteinizing hormone induced by the antiandrogenic potential of linuron. This study is classified as Acceptable/ Nonguideline as a special mechanistic study in rats. 5.5.3 Special Reproduction Study ­ Cross­ mating ­ Rat MRID No: 00159846 Executive Summary: A special study (MRID 00159846) was conducted to evaluate the effects of linuron (94.5% a. i.) on the reproduction and lactation performance of crossmated male and female Crl: CD®( SD) BR rats. The rats utilized for this study were the F2 adults from a multigeneration study and the current study was initiated within two weeks after weaning of the last F3a litter. High­ dose (625 ppm) and control animals were cross­ mated to produce F3b and F3c litters; different pairings were made for production of each litter. The data from the original F2 control group from the multigeneration study was used as control data for the current study, but the animals were not remated. The fertility index was calculated in the report as (no. litters delivered/ no. females mated) x 100. The reviewer calculated the following indices: male fertility index = (no. males impregnating females/ no. males exposed to females) x 100; female fertility index = (no. females conceiving/ no. females exposed to males) x 100; and fecundity index = (no. pregnancies/ no. copulations) x 100. During production of both litters, the fertility index and the number of pups/ litter at birth and at weaning were reduced as compared with the control values. The fertility indices for control females crossed with treated males and for treated females crossed with control males were 11.8 and 47.4%, respectively, for the F3b litters and 41.2 and 42.1%, respectively, for the F3c litters as compared with 89.5% for the controls. The number of pups/ litter at birth was 4.0­ 9.2 for the cross­ mated groups and 13.1 for the controls. At weaning the number of pups/ litter was 4.0­ 4.3 for the F3b litters and the F3c litters from treated females crossed with control males compared with 8.1 pups/ litter for both the control group and the F3c litters from control females crossed with treated males. In production of both litters, male and female fertility indices for the groups in which the males were treated were reduced (47­ 71% for males and 47­ 60% for females) compared with those for groups in which the females were treated (90­ 86% for males and 85­ 85% 31 for females). The fecundity index was reduced only for treated males crossed with control females during production of the F3b litters (25%) as compared with the other groups (56.2­ 63.6%). Pup viability was decreased in litters from treated dams mated with control males as compared with litters from control dams mated with treated males. Pup viability for days 0­ 4 was 77.5% in litters from treated dams and 98.5% in litters from control dams while viability for days 1­ 4 was 88.6% and 98.7%, respectively. Litter survival was 75% from treated dams compared with 100% from control dams. Mean pup body weights from treated dams were also slightly or significantly (p # 0.05) less than those from the control dams throughout lactation. The cross­ mating results suggest that linuron may cause paternally­ mediated effects based on decreased fertility and fecundity as well as maternally­ mediated effects based on decreased pup viability and litter survival. This study is classified as Acceptable/ Nonguideline as a special cross­ mating study in rats. 5.6 Additional Information from Literature Sources 5.6.1 McIntyre BS, Barlow NJ, Wallace DG, Maness SC, Gaido KW, Foster PM, Effects of in utero exposure to linuron on androgen­ dependent reproductive development in the male Crl: CD( SD) BR rat. Toxicol Appl Pharmacol 167( 2): 87­ 99 (2000) Pregnant rats were administered linuron by gavage at 0, 12.5, 25, or 50 mg/ kg/ day (n = 11/ group) from gestation day 12 to 21. Anogenital distance of resulting offspring was unaffected, whereas male areola/ nipple retention per rat was increased at 12.5, 25, and 59 mg/ kg/ day (1.0, 1.6, and 3.7, respectively) compared to the control (< 1.0). Hypoplastic testes in adult offspring were seen in 2/ 56 rats (2/ 10 litters), 8/ 69 rats (4/ 11 litters), and 5/ 44 rats (3/ 8 litters), while hypoplastic epididymides occurred in 1/ 56 rats (1/ 10 litters), 8/ 69 rats (4/ 11 litters), and 2/ 44 rats (1/ 8 litters) in the 12.5, 25, and 50 mg/ kg/ day dose groups, respectively. Partial agenesis of the epididymides was observed in 3/ 44 rats (2/ 8 litters) only in the 50 mg/ kg/ day group. These data indicate that in utero exposure to linuron preferentially impairs testosterone­ mediated, rather than DHT­ mediated, reproductive development. This effect is distinctly different from the effects induced by flutamide, an AR antagonist that shares structural similarities with linuron. 5.6.2 Lambright C, Ostby J, Bobseine K, Wilson V, Hotchkiss AK, Mann PC, 32 Gray LE, Cellular and molecular mechanisms of action of linuron: an antiandrogenic herbicide that produces reproductive malformations in male rats. Toxicol Sci 56( 2): 389­ 99 (2000) In vitro, linuron binds human AR (hAR), and and acts as an hAR antagonist. Linuron competed with an androgen for rat prostatic AR EC50 = 100­ 300 microM) and human AR (hAR) in a COS cell­ binding assay EC50 = 20 microM). Linuron inhibited dihydrotestosterone (DHT)­ hAR induced gene expression in CV­ 1 and MDA­ MB­ 453­ KB2 cells EC50 = 10 microM) at concentrations that were not cytotoxic. Linuron (oral 100 mg/ kg/ d for 7 days) treatment reduced testosterone­ and DHT­ dependent tissue weights in the Hershberger assay using castrate­ immature­ testosterone propionate­ treated male rats and altered the expression of androgen­ regulated ventral prostate genes (oral 100 mg/ kg/ d for 4 days). [The Hershberger assay is an EDSTAC Tier 1 assay to provide in vivo screening data relevant to androgen agonism and antagonism for preliminary hazard identification.] Histological effects of in utero exposure to linuron (100 mg/ kg/ d, day 14­ 18) or DBP (500 mg/ kg/ d, day 14 to postnatal day 3) on the testes and epididymides also are shown here. These results support the hypothesis that linuron is an AR antagonist both in vivo and in vitro, but it remains to be determined if linuron alters sexual differentiation by additional mechanisms of action. 5.6.3 Gray LE, Wolf C, Lambright C, Mann P, Price M, Cooper RL, Ostby J, Administration of potentially antiandrogenic pesticides (procymidone, linuron, iprodione, chlozolinate, p, p'­ DDE, and ketoconazole) and toxic substances dibutyland diethylhexyl phthalate, PCB 169, and ethane dimethane sulphonate) during sexual differentiation produces diverse profiles of reproductive malformations in the male rat. Toxicol Ind Health 15( 1­ 2): 94­ 118 (1999) Linuron (100 mg/ kg/ day) treatment induced a level of external effects consistent with its low affinity for AR [reduced anogenital distance (AGD), retained nipples, and a low incidence of hypospadias]. Linuron treatment also induced malformed epididymides and testis atrophy. The results suggest that Linuron may display several mechanisms of endocrine toxicity, one of which involves AR binding 5.6.4 Vinggaard, AM, Hnida, C, Breinholt, V and Larsen, JC, Screening of 33 Selected Pesticides for Inhibition of CYP19 Aromatase Activity In vitro, Toxicol in Vitro 14: 227­ 234 (2000) Linuron was tested for its ability to affect CYP19 aromatase activity in human placental microsomes using the classical [ 3 H] 20 method. Linuron did not affect CYP19 aromatase activity in human placental microsomes. The positive control, 4­ hydroxyandrostendione (1 : m), caused a 74% inhibition of CYP19 aromatase activity and a 94% inhibition of aromatase activity in JEG­ 3 human carcinoma cells. 5.6.5 Vinggaard, AM, Breinholt, V and Larsen, JC, Screening of selected pesticides for oestrogen receptor activation in vitro, Food Addit Contam 16 (12), 533­ 542 (1999) Linuron, tested in the oestrogen receptor in vitro using an MCF7 cell proliferation assay and a Yeast Oestrogen screen, did not effect the proliferation response after 6 days of exposure. 5.6.6 Cook, J. C., Mullin, L. S., Frame, S. R., Biegel, L. B., Investigation of a Mechanism for Leydig Cell Tumorigenesis by Linuron in Rats, Toxicol Appl Pharmacol 119( 2): 195­ 204 (1993) Serum testosterone, estradiol, and luteinizing hormone (LH) concentrations in sexually immature rats and testosterone and LH concentrations in sexually mature rats were significantly increased. Linuron significantly decreased body weight and relative epididymides, accessory sex organ, prostate, and seminal vesicle weights in sexually immature rats and body weight and relative accessory sex organ and prostate weights in mature rats. Serum estradiol and LH concentrations were significantly increased in sexually mature rats. Estradiol, LH, and testosterone concentrations were not affected in immature males. Linuron significantly decreased body weights and increased serum LH and estradiol concentrations in both parental and F1rats. Linuron was found to compete with testosterone for binding to the androgen receptor. The authors conclude that linuron apparently induces Leydig tumors by disrupting the hypothalamic/ pituitary/ testicular axis which leads to a sustained hypersecretion of LH. 34 5.7 Determination of Susceptibility There is no qualitative/ quantitative evidence of increased susceptibility of rabbit developmental study; developmental effects were seen at a dose higher than that causing maternal toxicity. In the rat developmental study, increases in post­ implantation losses and increases in fetal resorptions/ litter were seen as a dose that caused decreases in maternal body weight and food consumption. The HIARC determined that the developmental effects are not indicative of qualitative evidence of susceptibility., since increases in resorptions were marginal and there was no change in the number of live fetuses to corroborate the increases in post­ implantation losses. There was no quantitative evidence of susceptibility either in the 2­ generation or the 3­ generation reproduction studies. In the 2­ generation study, reduced body weight gains of pups were seen at the same dose that caused decreases in parental body weights. In the 3­ generation study, offspring effects (deceased pup survival and pup body weight) were seen a dose ( 44 mg/ kg/ day) higher than the dose that caused decreases in body weight gain in the parental animals (9 mg/ kg/ day). However, when the reproductive effects were examined, testicular atrophy was seen at the same dose (625 ppm, 45 mg/ kg/ day) in both studies. In both studies, while the F0 males were not affected, testicular lesions and reduced fertility were seen in the F1 males. This effect in the F1 males is an indication of qualitative evidence of susceptibility. 5.8 Evidence that suggest study requiring a Developmental Neurotoxicity Study: From special studies and open literature publications, Linuron was shown to be an endocrine disruptor. Key findings include: (1) Linuron and some of its metabolites are androgen receptor antagonists [§ 5.5.2] (2) Rats treated with linuron had reduced anogenital distance, retention of nipples, and a low incidence of hypospadias. [§ 5.5.3]. (3) The responsiveness of Leydig cells to luteinizing hormone was decreased in both immature (22 days) and mature (11 months) male rats treated with linuron. Mature rats were less responsive that immature ones [§ 5.4.3] (4) F0 and F1 males had significantly increased levels of estradiol and and luteinizing hormone [§ 5.4.4]. (5) Linuron inhibits activities of steroidogenic enzymes [§ 5.4.3] (6) A dose­ dependent increase in areola/ nipple retention in male rats [§ Although there was no evidence for increased susceptibility in rats, based on the findings that linuron is an endocrine disruptor, increased testicular lesions and decreased fertility, the HIARC concluded that a development neurotoxicity study in the rat is required. 6 HAZARD CHARACTERIZATION 35 The toxicological database for linuron is considered adequate for hazard characterization. At the time of this review, there are no toxicological data gaps and no outstanding toxicological concerns. Linuron has low acute toxicity, with toxicity categories of III for oral (LD50 2600 mg/ kg), dermal (LD50 > 2000 mg/ kg) and toxicity category IV for inhalation ( LC50 > 218 mg/ L/ hr). Primary eye and skin irritation studies were category III and IV, respectively; no dermal sensitization was observed in rabbits. Chronic toxicity studies in the dog, rat and mouse showed altered hematological findings. Beagle dogs fed linuron at dietary concentration of 625 ppm, resulted in hemolytic anemia and secondary erythropogenic activity evidenced by slightly reduced hemoglobin, hematocrit, and erythrocyte counts accompanied by hemosiderin deposition in liver Kupffer cells and erythroid hyperplasia of bone marrow. ChR­ CD rats fed diets containing Linuron at 125 ppm (5.11 mg/ kg/ day in males and 7.75 mg/ kg/ day in females), microscopic observations consistent with hemolysis (hemosiderin in Kupffer cells and increased hemosiderosis in bone marrow, spleen, and/ or mesenteric lymph nodes). Rats also showed decreased body weight gains in both sexes increased incidences of microscopic changes in the epididymides (perivasculitis/ vasculitis) and renal pelvis (transitional cell hyperplasia and mineralization/ calculi) of males and kidneys (calculi in renal tubules) of females. Systemic toxicity observed in mice included increased methemoglobin formation and vacuolation and hemosiderosis of the spleen. Oncogenicity studies in the rat and mouse did not show consistent tumor profiles between sexes and species. In rats there was a significant increase in the incidence of testicular interstitial cell adenomas in males, while no treatment­ related neoplasms were observed in females. In a mouse oncogenicity study a statistically significant increase in liver tumors was observed in females. Based on the results of these studies, linuron was classified as an unquantifiable Group C carcinogen (a possible human carcinogen for which there is limited animal evidence). In a developmental toxicity study using rats, the highest dose level caused maternal toxic effects including decreased body weight gain and food consumption, as well as increased postimplantation loss and fetal resorptions. In a study using rabbits, linuron caused decreases in maternal body weight, food consumption and liver weight, as well as more abortions, fewer fetuses per litter, decreased fetal body weight, and an increased incidence of fetuses with skeletal skull variations. In a 2­ generation reproductive toxicity study using rats, linuron caused effects on the parents including decreased body weight gain and abnormalities in the eyes and testes. Rats exposed to linuron could develop cell tumors in testicular tissue. A 3­ generation study using rats showed reduced body weights and fertility, decreased pup survival, and decreased weanling body, liver and kidney weights, as well as liver atrophy. The chronic toxicity of linuron has been evaluated in two­ year feeding studies in both the rat and dog. Body weights were measured weekly during the entire study. In the rat study, after one 36 week of treatment, a significant decrease in body weight gain was observed at 600 ppm in males (59% of control) and females (53% of control). These decreases persisted throughout the entire study, with females showing a consistently lower body weight gains (68 to 76%) than males (82 to 93%). The decreases in body weight gains correlated to some degree with decreased food consumption. Linuron was not mutagenic in bacteria or in cultured mammalian cells. There was also no indication of a clastogenic effect up to toxic doses in vivo. In oncogenicity studies in the rat and mouse tumors were observed, however, no sex and species differences were noted. In the mouse oncogenicity study, a significant increase in malignant lymphomas were observed in the spleen of females. In the combined chronic toxicity/ oncogenicity study in rats, testicular adenomas were observed in 16 and 58% of males at 600 and 1800 ppm, respectively, compared to 6% in both control and low­ dose groups. In female rats, the incidence of endometrial polyps was observed at 600 (15%) and 1800 (13%) ppm, compared to 4% for control and 8% at 200 ppm. There is ample evidence from special studies submitted by the registrant as well as open literature studies which indicate that linuron is an endocrine disruptor. These findings include, in part: (1) competitive androgen receptor antagonist [§ 5.6.2]; but not an estrogen receptor antagonist [§ 5.6.5]; (2) competitive inhibition of the transcriptional activity of dihydrotestosterone (DHT)­ human androgen receptor (hAR) in vitro [§ 5.6.1, §5.6.3], decreased anogenital distance [§ 5.6.3] and/ or an increase in the retention of areolae/ nipples [§ 5.6.1, §5.6.3] in male offspring following in utero exposure to linuron; (3) inhibition of steroidogenic enzymes [§ 5.6.4], and (4) decreased responsiveness of Leydig cells to luteinizing hormone in both immature (22 days) and mature (11 months) male rats treated with linuron, mature rats were less responsive that immature ones [§ 5.5.1]; (5) F0 and F1 males had significantly increased levels of estradiol and luteinizing hormone [§ 5.5.2]. 7 DATAGAPS Developmental neurotoxicity study ­Rat 28­ day inhalation study ­ Rat. 37 8 ACUTE TOXICITY Acute Toxicity of Linuron, Technical Guideline No. Study Type MRID No. Results Toxicity Category 81­ 1 Acute Oral (Rat) 00027625 2600 mg/ kg III 81­ 2 Acute Dermal (Rabbit) 00027625 > 2000 mg/ kg III 81­ 3 Acute Inhalation (Rat) 00053769 > 218 mg/ L/ hr IV 81­ 4 Primary Eye Irritation 42849001 Slight conjunctival redness at 24 hrs; clear at 72 hrs III 81­ 5 Primary Skin Irritation 42849002 Not an irritant IV 81­ 6 Dermal Sensitization 00146868 Not a sensitizer N/ A 38 9 SUMMARY OF TOXICOLOGY ENDPOINT SELECTION The doses and toxicological endpoints selected for various exposure scenarios are summarized below. EXPOSURE SCENARIO DOSE (mg/ kg/ day) ENDPOINT STUDY Acute Dietary (Females 13­ 50) NOAEL= 12 UF = 100 Increased post­ implantation loss and fetal/ litter resorptions at 50 mg/ kg/ day (LOAEL). Rat Prenatal Developmental Toxicity (MRID 00018167) Acute RfD (Females 13­ 50 years old) = 0.12 mg/ kg Acute Dietary (General Population) No appropriate effects attributed to a single exposure was identified. Chronic Dietary NOAEL = 0.77 UF = 100 Increased met­ and sulfhemoglobin levels at LOAEL (4.17 mg/ kg/ day, males; 3.5 mg/ kg/ day, females). Chronic Oral / Dog Chronic RfD = 0.0077 mg/ kg/ day Incidental Oral Short­ Term NOAEL= 5.8 Statistically and biologically significant decrease in premating body weights in F0 and F1 animals observed at 36 mg/ kg/ day (LOAEL). 2­ Generation Reproduction Study/ Rat Incidental Oral Intermediate­ Term NOAEL = 0.77 Increased met­ and sulfhemoglobin concentrations after 3 and 6 months exposure4.17 mg/ kg/ day (males) and 3.5 mg/ kg/ day (females). Chronic Oral / Dog Dermal 1 Short­ Term NOAEL= 5.8 Statistically and biologically significant decrease in premating body weights in F0 and F1 animals observed at 36 mg/ kg/ day (LOAEL). 2­ Generation Reproduction Study/ Rat Dermal 1 Intermediate­ Term NOAEL = 0.77 Increased met­ and sulfhemoglobin concentrations after 3 and 6 months exposure4.17 mg/ kg/ day (males) and 3.5 mg/ kg/ day (females). Chronic Oral / Dog Dermal 1 Long­ Term NOAEL = 0.77 Increased met­ and sulfhemoglobin concentrations after 9 and 12 months exposure4.17 mg/ kg/ day (males) and 3.5 mg/ kg/ day (females). Chronic Oral / Dog Inhalation 2 Short­ Term NOAEL= 5.8 Statistically and biologically significant decrease in premating body weights in F0 and F1 animals observed at 36 mg/ kg/ day (LOAEL). 2­ Generation Reproduction Study/ Rat Inhalation 2 Intermediate­ Term NOAEL = 0.77 Increased met­ and sulfhemoglobin concentrations after 3 and 6 months exposure4.17 mg/ kg/ day (males) and 3.5 mg/ kg/ day (females). Chronic Oral / Dog Inhalation 2 Long­ Term NOAEL = 0.77 Increased met­ and sulfhemoglobin concentrations after 9 and 12 months exposure4.17 mg/ kg/ day (males) and 3.5 mg/ kg/ day (females). Chronic Oral / Dog 1 The dermal absorption factor of 16% should be applied to extrapolate from the oral route to the dermal route. 2 100% absorption rate (default value) should be used to extrapolate from the oral route to the inhalation route.

epa

2024-06-07T20:31:41.872250

regulations

EPA-HQ-OPP-2002-0079-0008

Supporting & Related Material

1 TXR NO. 0050322 December 6, 2001 MEMORANDUM SUBJECT: LINURON: Report of the FQPA Safety Factor Committee. FROM: Carol Christensen, Acting Executive Secretary FQPA Safety Factor Committee Health Effects Division (7509C) THROUGH: Ed Zager, Chair FQPA Safety Factor Committee Health Effects Division (7509C) TO: Carol Christensen, Risk Assessor Registration Action Branch 2 Health Effects Division (7509C) PC Code: 035506 The Health Effects Division (HED) FQPA Safety Factor Committee met on November 26, 2001 to evaluate the hazard and exposure data for linuron and recommended that the FQPA safety factor (as required by the Food Quality Protection Act of August 3, 1996) be retained when assessing the risks posed from the use of this pesticide. I. HAZARD ASSESSMENT 2 (Correspondence: R. Fricke to C. Christensen, October 31, 2001) 1. Adequacy of Toxicity Database The toxicology data base for linuron is complete for FQPA assessment. The toxicology data bases for linuron were reviewed by the Hazard Identification Assessment Review Committee (HIARC) on September 13 th and 27 th . Prenatal developmental toxicity studies in the rat and rabbit and a two­ generation reproduction study are available with linuron. 2. Determination of Susceptibility There is no qualitative/ quantitative evidence of increased susceptibility in the rabbit developmental study; developmental effects were seen at a dose higher than that causing maternal toxicity. In the rat developmental study, increases in post­ implantation losses and increases in fetal resorptions/ litter were seen a dose that caused decreases in maternal body weight and food consumption. The HIARC determined that the developmental effects are not a concern for qualitative evidence of susceptibility, since increases in resorptions were marginal and there was no change in the number of live fetuses to corroborate the increases in post­ implantation losses. There was no quantitative evidence of susceptibility either in the 2­ generation or the 3­ generation reproduction studies. In the 2­ generation study, reduced body weight gains of pups were seen at the same dose that caused decreases in parental body weights. In the 3­ generation study, offspring effects (deceased pup survival and pup body weight) were seen a dose higher than the dose that caused decreases in body weight gain in the parental animals. In both the 2­ generation and the 3­ generation rat reproductive toxicity studies, testicular atrophy was seen at the same dose that caused parental/ systemic toxicity. However, the HIARC determined that these lesions were of a concern and provide qualitative evidence of increased susceptibility because in both studies they were seen in the F1 males but not in F0 males. This indicates an adverse effect on the male reproductive system of the F1 generation. 3. Requirement of a Developmental Neurotoxicity Study The HIARC concluded that a development neurotoxicity study in the rat is required by the available evidence. This conclusion is based on the findings that linuron is a potential endocrine disruptor, as evidenced by the observation of increased testicular lesions and decreased fertility in the reproduction studies. II. EXPOSURE ASSESSMENT AND RISK CHARACTERIZATION 3 1. Dietary (Food) Exposure Considerations (Correspondence: J. Punzi to C. Christensen, November 15, 2001) Linuron is registered for pre­ plant and postemergent use on the following crops: asparagus, carrots, celery, corn (field & sweet), cotton, parsley, potato, sorghum, soybean, and wheat. The rates of application range from 0.5­ 4 lb ai/ A/ yr and may be applied 1 or 2 times per year. Linuron is mainly early season but a few crops have short PHI's (notably asparagus (1 day) and carrot (14 day)). There are no Codex, Canadian, or Mexican MRL's for this chemical. Due to the data collection methods, linuron and metabolites convertible to 3,4­ dichloroanaline require regulation. Residues of linuron are systemic, however, washing will remove some of the residue in some instances. Linuron residues are persistent. Monitoring data are available for this chemical, however, both PDP and FDA look for the parent only. In PDP data detection rates for carrots are about 35 % and residues frequently found at 0.2 and 0.3 ppm. Field trial residue data corrected for percent of crop treated will be used to estimate exposure. Residue reduction studies are available for asparagus (washing, boiling) and carrot and potato (cooking) and will be used to assess the dietary exposure for linuron. Carrots, meats, and milk will contribute significantly to the diet. Feeding studies indicate tolerances are needed for meats and milk, linuron is registered on many feed crops. The dietary exposure assessment is considered Tier 3. It will include field trial data corrected for percent of crop treated and the translation of cooking studies to various foods. The Committee recognizes that further refinement to the dietary food exposure analyses may be required as the risk assessment is developed. Therefore, provided the final dietary food exposure assessment includes the metabolites of regulatory concern and does not underestimate the potential risk for infants and children, the safety factor recommendations of this Committee stand. 2. Dietary (Drinking Water) Exposure Considerations (Correspondence: I. Abdel­ Saheb to C. Christensen, dated November 20, 2001) The environmental fate data base for parent linuron is complete for FQPA assessment. Parent linuron appears to be moderately persistent and relatively immobile. Information on the persistence, mobility and dissipation pathways of several degradates of linuron is limited. However, EFED believes that there is no reason to believe that the EECs produced for the drinking water for linuron will underestimate the risk from its major degradates. Estimate are conservative because the metabolites are formed under aerobic soil metabolism conditions at low percentages and, therefore, no significant changes to the parent water numbers would result due to degradation. 4 A combination of modeling and monitoring data were used in the assessment. The Tier II screening models PRZM­ EXAMS with the Index Reservoir and Percent Crop Area adjustment (IR­ PCA PRZM/ EXAMS) were used to determine estimated surface water concentrations of linuron. The Screening Concentration in Groundwater (SCI­ GROW) model was used to estimate groundwater concentrations for linuron. However, because SCI­ GROW estimated concentrations of linuron were less than those from monitoring data, EFED recommends using monitoring results in the groundwater drinking water assessment. The FQPA Safety Factor Committee recognizes that further refinement to the dietary water exposure analyses may be required as the risk assessment is developed. Therefore, provided the final dietary water exposure assessment adequately assesses for metabolites of concern in drinking water and does not underestimate the potential risk for infants and children, the safety factor recommendations of this Committee stand. 3. Residential Exposure Considerations There are no registered residential uses of linuron. 5 III. SAFETY FACTOR RECOMMENDATION AND RATIONALE 1. FQPA Safety Factor Recommendation The Committee recommended that the FQPA safety factor for protection of infants and children (as required by FQPA) should be retained. 2. Rationale for Requiring the FQPA Safety Factor The FQPA SFC concluded that a safety factor is required because: 1. A qualitative increase in susceptibility seen in the F1 males in the rat reproductive toxicity study; and 2. A developmental neurotoxicity study in rats is required for the chemical because linuron is a potential endocrine disruptor and there is evidence for testicular lesions and decreased fertility in the rat reproductive toxicity study. However, the Committee concluded that the safety factor could be reduced to 3x for linuron because: 1. The toxicology database is complete; 2. The dietary (food and water) exposure assessments will not underestimate the potential exposures for infants, children, and/ or women of childbearing age; and, 3. There are no residential uses. 3. Application of the Safety Factor ­ Population Subgroups / Risk Assessment Scenarios Females 13­ 50 Population Subgroup: When assessing Acute Dietary exposure, the safety factor should be reduced to 3x since the developmental neurotoxicity study in rats is required. The developmental neurotoxicity study may further define the neurotoxic (neuro­ endocrine) potential observed in rats that were exposed in pre­ and post­ natal time periods. All Population Subgroups: When assessing Chronic Dietary, the safety factor should be Retained at 10x since there is concern for the qualitative increase in susceptibility observed in the rat reproductive toxicity study, and, since the developmental neurotoxicity study in rats is required. The developmental neurotoxicity study may further define the neurotoxic (neuro­ endocrine) potential observed in rats due to pre­ and post­ natal exposure.

epa

2024-06-07T20:31:41.885883

regulations

EPA-HQ-OPP-2002-0079-0009

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Date: 1/ 14/ 02 MEMORANDUM: Drinking Water Assessment for Linuron metabolites on Carrots in California. TO: Carol Christensen Reregistration actions Branch II Health Effects Division (7509C) FROM: Ibrahim Abdel­ Saheb/ Agronomist Environmental Risk Branch II Environmental Fate and Effects Division (7507C) PEER REVIEW: Ian Kennedy/ Hydrologist Environmental Risk Branch II Environmental Fate and Effects Division (7507C) THRU: Tom Bailey, Branch Chief Environmental Risk Branch II Environmental Fate and Effects Division (7507C) Conclusions: In response to HED request (Carol Christensen on 12/ 21/ 01), the three major linuron metabolites * formed under aerobic soil conditions use on carrots in (EPA Reg. No. 1812­ 320) are represented by this memorandum. The degradate 3,4­ dichloroaniline (3,4­ DCA) was not included in this assessment. Based on the results from the aerobic soil metabolism study (MRID# 41625401), the degradate 3,4­ DCA was not detected (0.01 ppm detection limit). According to acceptable fate studies, 3,4­ DCA is formed under anaerobic aquatic conditions (conditions rarely found in the environment and/ or relevant to drinking water assessment) consisted of 1.5% of the applied linuron. *:( 3­( 3­, 4­ dichlorophenyl)­ 1­ methoxyurea) (desmethoxy linuron), (3­( 3­, 4­ dichlorophenyl)­ 1­ methoxy­ 1­ methylurea) (desmethoxy linuron), and 1­( 3­, 4­ dichlorophenyl) urea) (norlinuron) 2 EFED currently has no monitoring data for these degradates in surface or groundwater. The Tier II screening models PRZM 1 and EXAMS 2 with the Index Reservoir and Percent Crop Area adjustment (IR­ PCA PRZM/ EXAMS) were used to determine estimated surface water concentrations of the linuron metabolites listed above. The Screening Concentration in Groundwater (SCI­ GROW 3 ) model was used to estimate groundwater concentrations for linuron. Modeling results are shown in Table 1. Table 1. Estimated environmental concentrations in surface and groundwater for desmethyl linuron, demthoxy linuron, and nor linuron use on carrots. model EECs (µg/ L) desmethyl linuron demthoxy linuron norlinuron Surface water/ peak (90 th percentile annual daily max.) 1.69 3.26 1.26 Surface water/ 90 th percentile annual mean) 1.60 3.10 1.20 Surface water/ 36­ year overall mean 1.17 2.28 0.88 Groundwater/ peak and long term average 0.047 0.094 0.035 use( s) modeled two applications on carrots @ 0.04 lb ai/ acre, ground application two applications on carrots @ 0.08 lb ai/ acre, ground application two applications on carrots @ 0.03 lb ai/ acre, ground application PCA Default PCA (0.87) The IR­ PCA PRZM/ EXAMS modeling results indicate that desmethyl linuron, desmethoxy linuron and norlinuron have the potential to contaminate surface waters by spray drift, and runoff in areas with large amounts of annual rainfall. 3 Environmental Fate and Transport Assessment Although the environmental fate data base for parent linuron is essentially complete, two environmental fate data requirements (leaching/ adsorption/ desorption and terrestrial field dissipation studies) are not fulfilled. The environmental fate assessment for linuron is incomplete and tentative because information on the persistence, mobility and dissipation pathways of several degradates of linuron is not available. Parent linuron appears to be moderately persistent and relatively immobile. Increased mobility may occur under specific environmental conditions such as in coarse textured soils and soils with low levels of organic matter. Linuron dissipates principally by biotic processes such as microbial degradation. In surface soils with adequate organic matter, the combined processes of adsorption and microbial degradation would limit linuron's potential to migrate to ground water. Linuron could runoff to surface water bodies. In that case, it would degrade fairly rapidly to three primary metabolites (desmethoxy linuron, desmethyl linuron, norlinuron, and 3,4­ DCA, none of each is >10% of the applied linuron in the aerobic soil metabolism study). However, information on the persistence and mobility of these degradates is not currently available. Linuron exhibits some of the properties and characteristics of chemicals that have been detected in ground water, and linuron itself has been detected in ground water in four states (Georgia, Missouri, Virginia and Wisconsin). Linuron is moderately persistent with an aerobic soil metabolism half­ life ranging from 57 to 100 days. Because linuron is sufficiently persistent and may be mobile under certain environmental conditions, it has the potential to impact ground water quality. Linuron can be applied aerially or by ground spray and therefore could contaminate surface waters through spray drift. It has the potential to be somewhat persistent in surface waters, particularly those with low microbiological activity and long hydrological residence times. In a lab study, linuron degraded with a half­ life of less than 3 weeks in nonsterile anaerobic silt loam and sand soil: water (1: 1) systems. It may be less persistent in water and sediment under anaerobic conditions than under aerobic conditions. Its bioconcentration potential is relatively low. Linuron is not currently regulated under the Safe Drinking Water Act, and water supply systems are not required to sample 4 and analyze for it. The primary treatment processes employed by most water systems may not always be completely effective in removing linuron's degradates. As a result, the Agency does have some moderate concerns regarding potential risks of these degradates to surface water source supply systems. Surface Water Monitoring The EFED currently has no monitoring data on the concentrations of desmethyl linuron, desmethoxy linuron or nor linuron in surface water. Modeling Tier II surface water modeling was done using the Index Reservoir (IR) scenario and Percent Crop Area (PCA) factor applied after modeling. The index reservoir represents a potentially vulnerable drinking water source based on the geometry of an actual reservoir and its watershed in a specific area (Illinois), using regional screening specific cropping patterns, weather, soils, and other factors. The PCA is a generic watershed­ based adjustment factor which represents the portion of a watershed planted to a crop or crops and will be applied to pesticide concentrations estimated for the surface water component of the drinking water exposure assessment using PRZM/ EXAMS with the index reservoir scenario. EFED has limited fate and mobility data on these metabolites; thus, a combined residue approach was used to calculate their aerobic soil metabolism half­ lives (assuming equal toxicity) by the summation of the concentrations of the parent and its metabolites. The IR­ PCA PRZM/ EXAMS model use and fate input parameters for linuron in surface water are shown in Table 2. The IR­ PCA PRZM/ EXAMS model input and output files for linuron are shown in Appendix I. Table 2: IR­ PC PRZM/ EXAMS input parameters for desmethyl linuron, desmethoxy linuron, and nor linuron use on carrots in California. Input variable Input value & calculations Source/ Quality of data Crop name carrots carrots carrots label EPA Reg. No. 1812­ 320). 5 application rate (lb ai/ acre) 0.04 0.08 0.03 label EPA Reg. No. 1812­ 320). Linuron application rate X [the maximum conversion rate from the degradation of Linuron to degradate in aerobic soil metabolism studies) x( the molecular weight ratio of degradate to parent)]. Interval between appl. (d) 14 14 14 label EPA Reg. No. 1812­ 320). A p p l i c a t i o n efficiency 0.99 0.99 0.99 IR­ PCA Guidance 8 S p r a y d r i f t fraction 0.064 0.064 0.064 IR­ PCA Guidance Application method ground ground ground label (EPA Reg. No. 1812­ 362). DWRATE (day ­1 ) 0.002 0.002 0.002 MRID# 41625401; combined residue calculation, Input parameters guidance 9 ; single value X 3. DSRATE (day ­1 ) 0.002 0.002 0.002 MRID# 41625401; combined residue calculation Input parameters guidance; single value X 3 Kd (mL/ g) 0 * 0 0 No data available Henry (atm. m 3 /mole) 6.07X10 ­8 (calculate d) 6.07X10 ­8 (calcula ted) 6.07X10 8 (calcul ated) RED, 1994. Value for the parent (linuron) was used. KBACW (h ­1 ) 0.001 0.001 0.001 No aerobic aquatic data is available, the aerobic soil met. degradation rate was multiplied by 0.5. MRID# 41625401. Input parameters guidance. KBACS (h ­1 ) 0.0004 0.0004 0.0004 Anaerobic aquatic half­ life (21 days) was multiplied by 3. MRID# 40142501. Input parameters guidance . KDP (h ­1 ) 0.0006 0.0006 0.0006 MRID# 40103601; Input parameters guidance. KBH, KNH, KAH (h ­1 ) (stable) (stable) (stable ) MRID# 40916201; Input parameters guidance. Value for parent used. KPS (mL/ g) 0 0 0 MRID# 00148443; Input parameters guidance. MWT (g/ mole) 235.1 219.1 205.1 RED, 1994. Solubility @ 25 0 C (ppm) 81 81 81 RED, 1994. Value for parent used. Vapor pressure (torr) 1.5X10 ­5 1.5X10 ­5 1.5X10 ­5 The MERCK Index 10 . Value for parent used. *: Preliminary modeling using Kd of 0 and 2.7 resulted in little difference in EEC's. A Kd of 0 was used in this assessment as a worse scenario condition. 6 Assumptions and Uncertainties 11,12 In general, the use of input parameter values for the parent may increase the uncertainties in this assessment. Index Reservoir The Index reservoir represent potential drinking water exposure from a specific area (Illinois) with specific cropping patterns, weather, soils, and other factors. Use of the index reservoir for areas with different climates, crops, pesticides used, sources of water (e. g. rivers instead of reservoirs, etc), and hydrogeology creates uncertainties. In general, because the index reservoir represents a fairly vulnerable watershed, the exposure estimated with the index reservoir will likely be higher than the actual exposure for most drinking water sources. However, the index reservoir is not a worst case scenario, communities that derive their drinking water from smaller bodies of water with minimal outflow, or with more runoff prone soils would likely get higher drinking water exposure than estimated using the index reservoir. Areas with a more humid climate that use a similar reservoir and cropping patterns may also get more pesticides in their drinking water than predicted using this scenario. PRZM/ EXAMS uses the characteristics of a single soil to represent the soil in the basin. In fact, soils can vary substantially across even small areas, and this variation is not reflected in these simulations. PRZM/ EXAMS does not consider tile drainage. Areas that are prone to substantial runoff are often tile drained. Tile drainage contributes additional water and in some cases, additional pesticide loading to the reservoir. This may cause either an increase or decrease in the pesticide concentration in the reservoir. Tile drainage also causes the surface soil to dry out faster. This will reduce runoff of the pesticide into the reservoir. The watershed used as the model for the index reservoir (Shipman City Lake) does not have tile drainage in the cropped areas. EXAMS is unable to easily model spring and fall turnover. Turnover occurs when the temperature drops in the fall and the thermal stratification of the reservoir is removed. Turnover occurs again in the spring when the reservoir warms up. This results in complete mixing of the chemical through the water column at these times. Because of this inability, the Index Reservoir has been simulated without stratification. There is 7 data to suggest that Shipman City Lake, upon which the Index Reservoir is based, does indeed stratify in the deepest parts of the lake at least in some years. This may result in over or underestimation of the concentration in drinking water depending upon the time of the year and the depth the drinking water intake is drawing from. Percent Crop Area Correction Factor The PCA is a watershed­ based modification. Implicit in its application is the assumption that currently­ used field­ scale models reflect basin­ scale processes consistently for all pesticides and uses. In other words, we assume the field scale processes simulated by the coupled PRZM and EXAMS models are a reasonable approximation of pesticide fate and transport within a watershed that contains a drinking water reservoir. If the models fail to capture pertinent basin­ scale fate and transport processes consistently for all pesticides and all uses, the application of a factor that reduces the estimated concentrations predicted by modeling could, in some instances, result in inadvertently passing a chemical through the screen that may actually pose a risk. Some preliminary assessments made in the development of the PCA suggest that PRZM/ EXAMS may not be realistically capturing basin­ scale processes for all pesticides or for all uses. A preliminary survey of water assessments which compared screening model estimates to readily available monitoring data suggest uneven model results. In some instances, the screening model estimates are more than an order of magnitude greater than the highest concentrations reported in available monitoring data; in other instances, the model estimates are less than monitoring concentrations. Because of these concerns, the Science Advisory Panel (SAP) recommended using the PCA only for "major" crops in the Midwest. For other crops, development of PCA's will depend on the availability of relevant monitoring data that could be used to evaluate the result of the PCA adjustment. The spatial data used for the PCA came from readily­ available sources and have a number of inherent limitations: ° The size of the 8­ digit HUC [mean = 366,989 ha; range = 6.7­ 2,282,081 ha; n = 2,111] may not provide reasonable estimates of actual PCA's for smaller watersheds. The watersheds that drain into drinking water reservoirs are generally smaller than the 8­ digit HUC and may be better represented by watersheds defined for drinking water intakes. 8 ° The conversion of the county level data to watershed­ based percent crop areas assumes the distribution of the crops within a county is uniform and homogeneous throughout the county area. Distance between the treated fields and the water body is not addressed. ° The PCA's were generated using data from the 1992 Census of Agriculture. However, recent changes in the agriculture sector from farm bill legislation may significantly impact the distribution of crops throughout the country. The methods described in this report can rapidly be updated as more current agricultural crops data are obtained. The assumption that yearly changes in cropping patterns will cause minimal impact needs to be evaluated. The PCA adjustment is only applicable to pesticides applied to agricultural crops. Contributions to surface waters from nonagricultural uses such as urban environments are not wellmodeled Currently, non­ agricultural uses are not included in the screening model assessments for drinking water. The PCA does not consider percent crop treated because detailed pesticide usage data are extremely limited at this time. Detailed pesticide usage data are currently available for only a few states. Groundwater Monitoring The EFED has no monitoring data on the concentrations of desmethyl linuron, desmethoxy linuron or nor linuron in groundwater at the present time. There is a possibility that those metabolites were not intended to look for, or they might have been present at concentrations lower than that of the instruments used for the water samples collected The SCI­ GROW model was used to estimate potential groundwater concentrations of linuron. Table 3 shows the input parameter values used in SCI­ GROW modeling. Table 3. Input parameters for desmethyl linuron, desmethoxy linuron, and nor linuron used in the SCI­ GROW model. 9 Input variable Input value & calculations Source/ Quality of data 1 Application rate (lb ai/ acre) 0.0 4 0.0 8 0.0 3 (EPA Reg. No. 1812­ 320). Maximum No. of Applications 2 2 2 (EPA Reg. No. 1812­ 320). Koc (mL/ g) 208 208 208 MRID# 46007015 (median value for parent); Input parameters guidance. Aerobic Soil metabolism t1/ 2. (day) 99 99 99 MRID# 41625401; combined residue calculations, Input parameters guidance. Groundwater EECs predicted using the SCI­ GROW screening model are substantially less than those estimated for surface water using PRZM and EXAMS. However, persistence in groundwater should be longer. REFERENCES 1. Carsel, R. F., J. C. Imhoff, P. R. Hummel, J. M. Cheplick and J. S. Donigian, Jr. 1997. PRZM­ 3, A Model for Predicting Pesticide and Nitrogen Fate in Crop Root and Unsaturated Soil Zones: Users Manual for Release 3.0; Environmental Research Laboratory, Office of Research and Development, U. S. Environmental Protection Agency, Athens, GA. 2. Burns, L. A. March 1997. Exposure Analysis Modeling System (EXAMSII) Users Guide for Version 2.97.5, Environmental Research Laboratory, Office of Research and Development, U. S. Environmental Protection Agency, Athens, GA. 3. Barrett, M., 1997, Proposal For a Method to Determine Screening Concentration Estimates for Drinking Water Derived from Groundwater Studies, EFED/ OPP. 4. U. S GS. 1992. National Water Quality Assessment (NWQA), Pesticides National Synthesis Project, Annual Use: Linuron. 5. U. S GS. 1993. National Water Quality Assessment Program San Joaquin ­ Tulare Basins Study Unit, [Online]. Available at http:// ca. water. usgs. gov/ sanj_ nawqa/ data_ sw/ ifs. 1993. herb2. 6. The United State Department of Agriculture, Office of Pesticide Management Policy & Pesticide Impact Assessment Program. Crop Profile for Carrots in California, [Online]. A v a i l a b l e a t http:// pestdata. ncsu. edu/ cropprofiles/ Detail. CFM? FactShee 10 ts_ RecordID= 285. 7. USGS. 1998. Pesticides in Surface and Ground Water of the United States: Summary of Results of the National Water Quality Assessment Program, [Online]. Available at http://( NAWQA)= http:// ca. water. usgs. gov/ pnsp/ allsum/# t1. 8. Effland, W., N. Thurman, I. Kennedy, R. D. Jones, J. Breithaupt, J. Lin, J. Carleton, L. Libel. R. Parker, and R. Matzner. 2000. " Guidance for use of the index Reservoir and Percent Crop Area Factor in drinking water exposure assessment s. Office of Pesticide Programs. 9. Guidance for Chemistry and Management Practice Input Parameters For Use in Modeling the Environmental Fate and Transport of Pesticides. Version 2. November 7, 2000. U. S. EPA Office of Pesticide Programs, Environmental Fate and Effects Division. 10. The Merck Index. 1989. An encyclopedia of chemicals, drugs, and biologicals. 11 th ed. Rahway, N. J. p. 533. 11. Carsel, R. F., J. C. Imhoff, P. R. Hummel, J. M. Cheplick and J. S. Donigian, Jr. 1997. PRZM­ 3, A Model for Predicting Pesticide and Nitrogen Fate in Crop Root and Unsaturated Soil Zones: Users Manual for Release 3.0; Environmental Research Laboratory, Office of Research and Development, U. S. Environmental Protection Agency, Athens, GA. 12. U. S. Environmental Protection Agency. 1984. Chemical Information Fact Sheet Number 28: Linuron. Office of Pesticides and Toxic Substances, Washington, DC, 9­ 13. 13. U. S. EPA. 1992. Pesticides in Ground Water Database­ A compilation of Monitoring Studies: 1971 ­ 1991. Office of Prevention, Pesticides, and Toxic Substances, EPA 734­ 12­ 92­ 001. 14. U. S GS. 1998. National Water Quality Assessment (NWQA), Pesticides National Synthesis Project [Online] at http:// ca. water. usgs. gov/ pnsp/ allsum/# over. APPENDIX I IR­ PCA PRZM/ EXAMS INPUT FILE FOR THE USE OF DESMETHYL LINURON ON CARROTS IN CALIFORNIA 11 WTR WTR *********************************** WTR * PESTICIDE ROOT ZONE MODEL * WTR * RELEASE 3.12 Beta * WTR * February 1998 * WTR *********************************** WTR WTR *********************************** WTR WTR DEVELOPED FOR: WTR U. S. ENVIRONMENTAL PROTECTION AGENCY WTR OFFICE OF RESEARCH AND DEVELOPMENT WTR NATIONAL EXPOSURE RESEARCH LABORATORY WTR ECOSYSTEMS RESEARCH DIVISION WTR ATHENS, GEORGIA 30605­ 2700 WTR 706/ 355­ 8328 WTR Distributed by: Des Center for Exposure Assessment Modeling WTR http:// www. epa. gov/ CEAM WTR ceam@ epamail. epa. gov WTR WTR WTR WTR SIMULATION START DATE (DAY­ MONTH­ YEAR) 1 JAN., 48 WTR SIMULATION END DATE (DAY­ MONTH­ YEAR) 31 DEC., 83 WTR WTR WTR "Lerdo clay loam, MLRA C­ 17; Central Valley, CA, Carrots" WTR WTR WTR WTR WTR WTR HYDROLOGY AND SEDIMENT RELATED PARAMETERS WTR ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR PAN COEFFICIENT FOR EVAPORATION 0.7000 WTR FLAG FOR ET SOURCE (0= EVAP, 1= TEMP, 2= EITHER) 0 WTR DEPTH TO WHICH ET IS COMPUTED YEAR­ ROUND (CM) 17.0000 WTR SNOW MELT COEFFICIENT (CM/ DEG­ C­ DAY) 0.5000 WTR INITIAL CROP NUMBER 1 WTR INITIAL CROP CONDITION 1 WTR WTR WTR SOIL EROSION PARAMETERS WTR ­­­­­­­­­­­­­­­­­­­­­­ WTR WTR USLE "K" PARAMETER 0.2100 WTR USLE "LS" PARAMETER 1.000 WTR USLE "P" PARAMETER 1.000 12 WTR FIELD OR PLOT AREA (HA) 172.0 WTR STORM TYPE 3 WTR SLOPE 1.000 WTR HYDRAULIC LENGTH (M) 600.0 WTR WTR WTR CROPPING EROSION PARAMETERS WTR ­­­­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR WTR CROP NUMBER 1 WTR NUMBER OF USLEC FACTORS 3 WTR WTR # DAY MONTH USLEC MANNINGS N WTR WTR 1 1 1 0.100 0.020 WTR 2 21 9 0.100 0.000 WTR 3 22 9 0.100 ***** WTR WTR WTR CROP INFORMATION WTR ­­­­­­­­­­­­­­­ WTR WTR MAXIMUM SURFACE WTR INTERCEPT. MAXIMUM MAXIMUM MAXIMUM CONDITION MAXIMUM WTR CROP POTENTIAL ROOT DEPTH COVER WEIGHT AFTER HEIGHT AMC RUNOFF CURVE NUMBERS WTR NUMBER (CM) (CM) (%) (KG/ M** 2) HARVEST (CM) FALLOW CROP RESIDUE WTR WTR I 80 70 75 WTR 1 0.2000 60.00 80.00 0.0000 3 100.000 II 91 85 88 WTR III 96 93 95 WTR WTR WTR CROP ROTATION INFORMATION WTR ­­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR CROP EMERGENCE MATURATION HARVEST WTR NUMBER DATE DATE DATE WTR WTR 1 10 SEP., 49 23 DEC., 49 31 DEC., 48 WTR 1 10 SEP., 50 23 DEC., 50 31 DEC., 49 WTR 1 10 SEP., 51 23 DEC., 51 31 DEC., 50 WTR 1 10 SEP., 52 23 DEC., 52 31 DEC., 51 WTR 1 10 SEP., 53 23 DEC., 53 31 DEC., 52 WTR 1 10 SEP., 54 23 DEC., 54 31 DEC., 53 WTR 1 10 SEP., 55 23 DEC., 55 31 DEC., 54 WTR 1 10 SEP., 56 23 DEC., 56 31 DEC., 55 WTR 1 10 SEP., 57 23 DEC., 57 31 DEC., 56 WTR 1 10 SEP., 58 23 DEC., 58 31 DEC., 57 WTR 1 10 SEP., 59 23 DEC., 59 31 DEC., 58 13 WTR 1 10 SEP., 60 23 DEC., 60 31 DEC., 59 WTR 1 10 SEP., 61 23 DEC., 61 31 DEC., 60 WTR 1 10 SEP., 62 23 DEC., 62 31 DEC., 61 WTR 1 10 SEP., 63 23 DEC., 63 31 DEC., 62 WTR 1 10 SEP., 64 23 DEC., 64 31 DEC., 63 WTR 1 10 SEP., 65 23 DEC., 65 31 DEC., 64 WTR 1 10 SEP., 66 23 DEC., 66 31 DEC., 65 WTR 1 10 SEP., 67 23 DEC., 67 31 DEC., 66 WTR 1 10 SEP., 68 23 DEC., 68 31 DEC., 67 WTR 1 10 SEP., 69 23 DEC., 69 31 DEC., 68 WTR 1 10 SEP., 70 23 DEC., 70 31 DEC., 69 WTR 1 10 SEP., 71 23 DEC., 71 31 DEC., 70 WTR 1 10 SEP., 72 23 DEC., 72 31 DEC., 71 WTR 1 10 SEP., 73 23 DEC., 73 31 DEC., 72 WTR 1 10 SEP., 74 23 DEC., 74 31 DEC., 73 WTR 1 10 SEP., 75 23 DEC., 75 31 DEC., 74 WTR 1 10 SEP., 76 23 DEC., 76 31 DEC., 75 WTR 1 10 SEP., 77 23 DEC., 77 31 DEC., 76 WTR 1 10 SEP., 78 23 DEC., 78 31 DEC., 77 WTR 1 10 SEP., 79 23 DEC., 79 31 DEC., 78 WTR 1 10 SEP., 80 23 DEC., 80 31 DEC., 79 WTR 1 10 SEP., 81 23 DEC., 81 31 DEC., 80 WTR 1 10 SEP., 82 23 DEC., 82 31 DEC., 81 WTR 1 10 SEP., 83 23 DEC., 83 31 DEC., 82 WTR 1 10 SEP., 84 23 DEC., 84 31 DEC., 83 WTR WTR WTR desmethyl­ linuron ­ 2 applications @ .08 kg/ ha WTR WTR WTR WTR WTR WTR PESTICIDE APPLICATION INFORMATION WTR ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR CHEMICAL PESTICIDE INCORPORATION WTR PESICIDE APPLICATION APPLICATION APPLIED DEPTH WTR NAME DATE MODEL (KG/ HA) (CM) WTR WTR desmethyl­ linuron 10 DEC., 48 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 48 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 49 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 49 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 50 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 50 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 51 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 51 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 52 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 52 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 53 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 53 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 54 2 0.8000E­ 01 0.0000 14 WTR desmethyl­ linuron 24 DEC., 54 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 55 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 55 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 56 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 56 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 57 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 57 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 58 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 58 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 59 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 59 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 60 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 60 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 61 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 61 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 62 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 62 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 63 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 63 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 64 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 64 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 65 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 65 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 66 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 66 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 67 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 67 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 68 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 68 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 69 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 69 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 70 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 70 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 71 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 71 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 72 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 72 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 73 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 73 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 74 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 74 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 75 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 75 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 76 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 76 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 77 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 77 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 78 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 78 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 79 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 79 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 80 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 80 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 81 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 81 2 0.8000E­ 01 0.0000 15 WTR desmethyl­ linuron 10 DEC., 82 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 82 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 83 2 0.8000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 83 2 0.8000E­ 01 0.0000 WTR WTR WTR WTR PLANT PESTICIDE PARAMETERS WTR ­­­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR WTR FOLIAR PESTICIDE DECAY RATE (/ DAY) 0.0000 WTR EXTRACTION COEFFICIENT (/ CM) 0.0000 WTR FOLIAR PESTICIDE VOLATILIZATION RATE (/ DAY) 0.0000 WTR FILTRATION PARAMETER (M** 2/ MG) 0.0000 WTR AFTER HARVEST DATE, REMAINING CHEMICAL 1 IN CANOPY IS SURFACE APPLIED WTR PLANT UPTAKE EFFICIENCY FACTOR 0.0000 WTR WTR WTR Linuron WTR WTR WTR WTR WTR WTR GENERAL SOIL INFORMATION WTR ­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR CORE DEPTH (CM) 100.0 WTR TOTAL HORIZONS IN CORE 2 WTR THETA FLAG (0= INPUT, 1= CALCULATED) 0 WTR PARTITION COEFFICIENT FLAG (0= INPUT, 1= CALCULATED) 1 WTR BULK DENSITY FLAG (0= INPUT, 1= CALCULATED) 0 WTR SOIL HYDRAULICS MODULE (0= HYDR1,1= HYDR2) 0 WTR TRANSPORT SOLUTION TECHNIQUE (0= BACKDIFF, 1= MOC) 0 WTR IRRIGATION FLAG (0= OFF, 1= ON) 0 WTR TEMPERATURE CORRECTION (0= OFF, 1= ON) 0 WTR THERMAL CONDUCTIVITY (0= SUPPLIED, 1= CALCULATED) 0 WTR BIODEGRADATION FLAG (0= OFF, 1= ON) 0 WTR WTR PESTICIDE PROPERTY INFORMATION WTR ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ WTR HENRY'S LAW CONSTANT 0.0000 WTR DIFFUSION COEFFICIENT (CM** 2/ DAY) 0.0000 WTR WTR WTR WTR WTR SOIL HORIZON INFORMATION WTR ­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR INITIAL FIELD WILTING WTR SOIL 16 CAPACITY POINT WTR BULK WATER DRAINAGE LAT DRAIN WATER WATORGANIC WTR HORI­ THICK DENSITY CONTENT PARAMETER PARAMETER CONTENT CONTENT CARBON WTR ZON (CM) (G/ CM** 3) (CM/ CM) (/ DAY) (/ DAY) (CM/ CM) (CM/ CM) (%) WTR ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR 1 18.0 1.6000 0.325 0.00 0.00 .32500 0.175 0.017 WTR 2 82.0 1.5000 0.249 0.00 0.00 .24900 0.129 0.002 WTR WTR WTR HORIZON LAYER DEPTH (CM) WTR WTR 1 1.00 WTR 2 1.00 WTR WTR desmethyl­ linuron WTR WTR HORIZON 1 WTR ­­­­­­ WTR WTR LIQUID PHASE DECAY RATE (/ DAY) 0.000 WTR SOLID PHASE DECAY RATE (/ DAY) 0.000 WTR GAS PHASE DECAY RATE (/ DAY) 0.000 WTR DISPERSION COEFFICIENTS (CM** 2/ DAY) 0.000 WTR WTR HORIZON 2 WTR ­­­­­­ WTR WTR LIQUID PHASE DECAY RATE (/ DAY) 0.000 WTR SOLID PHASE DECAY RATE (/ DAY) 0.000 WTR GAS PHASE DECAY RATE (/ DAY) 0.000 WTR DISPERSION COEFFICIENTS (CM** 2/ DAY) 0.000 WTR WTR WTR WTR PLOT FILE INFORMATION WTR ­­­­­­­­­­­­­­­­­­­­ WTR WTR NUMBER OF PLOTTING VARIABLES 7 WTR TIMSER NAME MODE CMPT BEG CMPT END CONSTANT TYPE DSN WTR WTR PRCP TCUM 0 0 0.0000 P WTR RUNF TCUM 0 0 0.0000 P WTR INFL TCUM 1 1 0.0000 17 P WTR ESLS TCUM 0 0 1000. P WTR RFLX TCUM 0 0 0.1000E+ 06 P WTR EFLX TCUM 0 0 0.1000E+ 06 P WTR RZFX TCUM 0 0 0.1000E+ 06 P OUT 1948 12 31 24 0 0.0000 0.0000 0.0000 0.0000 OUT 1949 12 31 24 0 0.7272E­ 02 0.2764E­ 05 0.1450E­ 04 0.0000 OUT 1950 12 31 24 0 0.1715E­ 04 0.7148E­ 08 0.0000 0.0000 OUT 1951 12 31 24 0 0.2451E­ 04 0.1065E­ 07 0.3223E­ 01 0.0000 OUT 1952 12 31 24 0 0.5911E­ 03 0.5074E­ 06 0.0000 0.0000 OUT 1953 12 31 24 0 0.2277E­ 03 0.1693E­ 06 0.0000 0.0000 OUT 1954 12 31 24 0 0.5584E­ 03 0.4811E­ 06 0.4856E­ 02 0.0000 OUT 1955 12 31 24 0 0.4446E­ 04 0.1990E­ 07 0.0000 0.0000 OUT 1956 12 31 24 0 0.3226E­ 05 0.1185E­ 08 0.0000 0.0000 OUT 1957 12 31 24 0 0.1621E­ 04 0.6704E­ 08 0.1327 0.0000 OUT 1958 12 31 24 0 0.1110E­ 04 0.4766E­ 08 0.0000 0.0000 OUT 1959 12 31 24 0 0.1465E­ 03 0.8693E­ 07 0.7153E­ 01 0.0000 OUT 1960 12 31 24 0 0.3714E­ 05 0.1540E­ 08 0.2880E­ 01 0.0000 OUT 1961 12 31 24 0 0.9531E­ 05 0.3627E­ 08 0.9078E­ 01 0.0000 OUT 1962 12 31 24 0 0.9341E­ 04 0.5453E­ 07 0.9446E­ 01 0.0000 OUT 1963 12 31 24 0 0.1914E­ 03 0.1262E­ 06 0.2423E­ 02 0.0000 OUT 1964 12 31 24 0 0.1466E­ 03 0.1059E­ 06 0.2264E­ 01 0.0000 OUT 1965 12 31 24 0 0.1442E­ 03 0.1015E­ 06 0.2508 0.0000 OUT 1966 12 31 24 0 0.1344E­ 04 0.7784E­ 08 0.0000 0.0000 OUT 1967 12 31 24 0 0.2532E­ 03 0.2033E­ 06 0.4021E­ 01 0.0000 OUT 1968 12 31 24 0 0.3737E­ 03 0.3214E­ 06 0.1983E­ 01 0.0000 OUT 1969 12 31 24 0 0.1415E­ 03 0.1011E­ 06 0.3613E­ 01 0.0000 OUT 1970 12 31 24 0 0.1417E­ 03 0.9263E­ 07 0.3688E­ 01 0.0000 18 OUT 1971 12 31 24 0 0.3487E­ 04 0.1695E­ 07 0.3186E­ 01 0.0000 OUT 1972 12 31 24 0 0.1316E­ 03 0.8437E­ 07 0.1019 0.0000 OUT 1973 12 31 24 0 0.2615E­ 04 0.1424E­ 07 0.5410E­ 01 0.0000 OUT 1974 12 31 24 0 0.2504E­ 03 0.1762E­ 06 0.1996E­ 02 0.0000 OUT 1975 12 31 24 0 0.3815E­ 04 0.2029E­ 07 0.2573E­ 02 0.0000 OUT 1976 12 31 24 0 0.9317E­ 05 0.4169E­ 08 0.0000 0.0000 OUT 1977 12 31 24 0 0.5604E­ 04 0.3121E­ 07 0.4435E­ 01 0.0000 OUT 1978 12 31 24 0 0.9286E­ 04 0.5833E­ 07 0.2292E­ 01 0.0000 OUT 1979 12 31 24 0 0.8713E­ 04 0.4885E­ 07 0.3489E­ 01 0.0000 OUT 1980 12 31 24 0 0.7427E­ 05 0.2852E­ 08 0.5095E­ 01 0.0000 OUT 1981 12 31 24 0 0.1472E­ 04 0.8863E­ 08 0.0000 0.0000 OUT 1982 12 31 24 0 0.4429E­ 04 0.2505E­ 07 0.3448E­ 01 0.0000 OUT 1983 12 31 24 0 0.3898E­ 04 0.2235E­ 07 0.3803E­ 02 0.0000 IR­ PCA PRZM/ EXAMS OUTPUT FILE FOR THE USE OF DESMETHYL LINURON ON CARROTS IN CALIFORNIA Chemical: desmethyl­ linuron PRZM environment: dsmthl1. txt EXAMS environment: IRPRZM0. EXV Metfile: met17. met Water segment concentrations (ppb) Year Peak 96 hr 21 Day 60 Day 90 Day Yearly 1948 0.1866 0.1865 0.1288 0.046620.03108 0.008098 1949 0.3617 0.3615 0.304 0.2228 0.2078 0.1896 1950 0.5276 0.5273 0.47 0.3897 0.3751 0.3602 1951 0.6856 0.6837 0.6263 0.5467 0.5327 0.5219 1952 0.8373 0.8327 0.7558 0.6753 0.6705 0.6532 1953 0.9711 0.9705 0.9139 0.8359 0.8324 0.8194 1954 1.236 1.235 1.179 1.111 1.108 1.085 1955 1.346 1.345 1.289 1.231 1.227 1.206 1956 1.363 1.362 1.342 1.34 1.337 1.294 1957 1.504 1.502 1.439 1.367 1.364 1.342 1958 1.496 1.496 1.495 1.493 1.482 1.356 1959 1.551 1.55 1.494 1.444 1.441 1.417 1960 1.584 1.582 1.577 1.567 1.562 1.508 19 1961 1.578 1.577 1.521 1.473 1.47 1.445 1962 1.574 1.574 1.574 1.517 1.459 1.355 1963 1.545 1.544 1.488 1.463 1.456 1.417 1964 1.64 1.639 1.584 1.539 1.536 1.509 1965 1.821 1.764 1.636 1.633 1.626 1.569 1966 1.81 1.808 1.801 1.781 1.765 1.715 1967 1.902 1.9 1.869 1.861 1.853 1.795 1968 1.945 1.944 1.896 1.894 1.888 1.834 1969 1.948 1.947 1.939 1.923 1.906 1.84 1970 1.943 1.943 1.943 1.936 1.926 1.875 1971 1.944 1.943 1.937 1.934 1.93 1.851 1972 1.944 1.943 1.939 1.936 1.932 1.861 1973 1.939 1.933 1.912 1.884 1.862 1.779 1974 1.88 1.879 1.878 1.875 1.858 1.755 1975 1.821 1.82 1.765 1.737 1.731 1.698 1976 1.904 1.903 1.848 1.817 1.814 1.782 1977 1.906 1.905 1.905 1.901 1.89 1.814 1978 1.887 1.886 1.882 1.686 1.509 1.224 1979 1.383 1.382 1.326 1.271 1.267 1.245 1980 1.452 1.451 1.395 1.365 1.356 1.32 1981 1.53 1.529 1.473 1.45 1.445 1.407 1982 1.563 1.562 1.526 1.525 1.52 1.461 1983 1.599 1.597 1.525 1.517 1.513 1.465 Sorted results Prob. Peak 96 hr 21 Day 60 Day 90 Day Yearly 0.027027027 1.948 1.947 1.943 1.936 1.932 1.875 0.054054054 1.945 1.944 1.939 1.936 1.93 1.861 0.081081081 1.944 1.943 1.939 1.934 1.926 1.851 0.108108108 1.944 1.943 1.937 1.923 1.906 1.84 0.135135135 1.943 1.943 1.912 1.901 1.89 1.834 0.162162162 1.939 1.933 1.905 1.894 1.888 1.814 0.189189189 1.906 1.905 1.896 1.884 1.862 1.795 0.216216216 1.904 1.903 1.882 1.875 1.858 1.782 0.243243243 1.902 1.9 1.878 1.861 1.853 1.779 0.27027027 1.887 1.886 1.869 1.817 1.814 1.755 0.297297297 1.88 1.879 1.848 1.781 1.765 1.715 0.324324324 1.821 1.82 1.801 1.737 1.731 1.698 0.351351351 1.821 1.808 1.765 1.686 1.626 1.569 0.378378378 1.81 1.764 1.636 1.633 1.562 1.509 0.405405405 1.64 1.639 1.584 1.567 1.536 1.508 0.432432432 1.599 1.597 1.577 1.539 1.52 1.465 0.459459459 1.584 1.582 1.574 1.525 1.513 1.461 0.486486486 1.578 1.577 1.526 1.517 1.509 1.445 0.513513514 1.574 1.574 1.525 1.517 1.482 1.417 0.540540541 1.563 1.562 1.521 1.493 1.47 1.417 0.567567568 1.551 1.55 1.495 1.473 1.459 1.407 0.594594595 1.545 1.544 1.494 1.463 1.456 1.356 0.621621622 1.53 1.529 1.488 1.45 1.445 1.355 0.648648649 1.504 1.502 1.473 1.444 1.441 1.342 0.675675676 1.496 1.496 1.439 1.367 1.364 1.32 0.702702703 1.452 1.451 1.395 1.365 1.356 1.294 0.72972973 1.383 1.382 1.342 1.34 1.337 1.245 0.756756757 1.363 1.362 1.326 1.271 1.267 1.224 0.783783784 1.346 1.345 1.289 1.231 1.227 1.206 0.810810811 1.236 1.235 1.179 1.111 1.108 1.085 0.837837838 0.9711 0.9705 0.9139 0.8359 0.8324 0.8194 0.864864865 0.8373 0.8327 0.7558 0.6753 0.6705 0.6532 0.891891892 0.6856 0.6837 0.6263 0.5467 0.5327 0.5219 0.918918919 0.5276 0.5273 0.47 0.3897 0.3751 0.3602 0.945945946 0.3617 0.3615 0.304 0.2228 0.2078 0.1896 20 0.972972973 0.1866 0.1865 0.1288 0.046620.03108 0.008098 0.1 1.944 1.943 1.9376 1.9263 1.912 1.8433 1.354899944 SCI­ GROW output file SCIGROW VERSION 2.1 MAY 1, 2001 RUN No. 1 FOR desmethyl linuron ** INPUT VALUES ** ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ APP RATE APPS/ TOTAL/ SOIL AEROBIC SOIL METAB (LBS/ AC) YEAR SEASON KOC HALFLIFE (DAYS) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ .040 2 .080 208.0 99.00 GROUND­ WATER SCREENING CONCENTRATION (IN PPB) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ .0471 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ IR­ PCA PRZM/ EXAMS INPUT FILE FOR THE USE OF DESMETHOXY LINURON ON CARROTS IN CALIFORNIA WTR WTR *********************************** WTR * PESTICIDE ROOT ZONE MODEL * WTR * RELEASE 3.12 Beta * WTR * February 1998 * WTR *********************************** WTR WTR *********************************** WTR WTR DEVELOPED FOR: WTR U. S. ENVIRONMENTAL PROTECTION AGENCY 21 WTR OFFICE OF RESEARCH AND DEVELOPMENT WTR NATIONAL EXPOSURE RESEARCH LABORATORY WTR ECOSYSTEMS RESEARCH DIVISION WTR ATHENS, GEORGIA 30605­ 2700 WTR 706/ 355­ 8328 WTR Distributed by: Des Center for Exposure Assessment Modeling WTR http:// www. epa. gov/ CEAM WTR ceam@ epamail. epa. gov WTR WTR WTR WTR SIMULATION START DATE (DAY­ MONTH­ YEAR) 1 JAN., 48 WTR SIMULATION END DATE (DAY­ MONTH­ YEAR) 31 DEC., 83 WTR WTR WTR "Lerdo clay loam, MLRA C­ 17; Central Valley, CA, Carrots" WTR WTR WTR WTR WTR WTR HYDROLOGY AND SEDIMENT RELATED PARAMETERS WTR ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR PAN COEFFICIENT FOR EVAPORATION 0.7000 WTR FLAG FOR ET SOURCE (0= EVAP, 1= TEMP, 2= EITHER) 0 WTR DEPTH TO WHICH ET IS COMPUTED YEAR­ ROUND (CM) 17.0000 WTR SNOW MELT COEFFICIENT (CM/ DEG­ C­ DAY) 0.5000 WTR INITIAL CROP NUMBER 1 WTR INITIAL CROP CONDITION 1 WTR WTR WTR SOIL EROSION PARAMETERS WTR ­­­­­­­­­­­­­­­­­­­­­­ WTR WTR USLE "K" PARAMETER 0.2100 WTR USLE "LS" PARAMETER 1.000 WTR USLE "P" PARAMETER 1.000 WTR FIELD OR PLOT AREA (HA) 172.0 WTR STORM TYPE 3 WTR SLOPE 1.000 WTR HYDRAULIC LENGTH (M) 600.0 WTR WTR WTR CROPPING EROSION PARAMETERS WTR ­­­­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR WTR CROP NUMBER 1 WTR NUMBER OF USLEC FACTORS 3 WTR WTR # DAY MONTH USLEC MANNINGS N WTR WTR 1 1 1 0.100 0.020 WTR 2 21 9 0.100 0.000 WTR 3 22 9 0.100 ***** WTR WTR WTR CROP INFORMATION WTR ­­­­­­­­­­­­­­­­ 22 WTR WTR MAXIMUM SURFACE WTR INTERCEPT. MAXIMUM MAXIMUM MAXIMUM CONDITION MAXIMUM WTR CROP POTENTIAL ROOT DEPTH COVER WEIGHT AFTER HEIGHT AMC RUNOFF CURVE NUMBERS WTR NUMBER (CM) (CM) (%) (KG/ M** 2) HARVEST (CM) FALLOW CROP RESIDUE WTR WTR I 80 70 75 WTR 1 0.2000 60.00 80.00 0.0000 3 100.000 II 91 85 88 WTR III 96 93 95 WTR WTR WTR CROP ROTATION INFORMATION WTR ­­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR CROP EMERGENCE MATURATION HARVEST WTR NUMBER DATE DATE DATE WTR WTR 1 10 SEP., 49 23 DEC., 49 31 DEC., 48 WTR 1 10 SEP., 50 23 DEC., 50 31 DEC., 49 WTR 1 10 SEP., 51 23 DEC., 51 31 DEC., 50 WTR 1 10 SEP., 52 23 DEC., 52 31 DEC., 51 WTR 1 10 SEP., 53 23 DEC., 53 31 DEC., 52 WTR 1 10 SEP., 54 23 DEC., 54 31 DEC., 53 WTR 1 10 SEP., 55 23 DEC., 55 31 DEC., 54 WTR 1 10 SEP., 56 23 DEC., 56 31 DEC., 55 WTR 1 10 SEP., 57 23 DEC., 57 31 DEC., 56 WTR 1 10 SEP., 58 23 DEC., 58 31 DEC., 57 WTR 1 10 SEP., 59 23 DEC., 59 31 DEC., 58 WTR 1 10 SEP., 60 23 DEC., 60 31 DEC., 59 WTR 1 10 SEP., 61 23 DEC., 61 31 DEC., 60 WTR 1 10 SEP., 62 23 DEC., 62 31 DEC., 61 WTR 1 10 SEP., 63 23 DEC., 63 31 DEC., 62 WTR 1 10 SEP., 64 23 DEC., 64 31 DEC., 63 WTR 1 10 SEP., 65 23 DEC., 65 31 DEC., 64 WTR 1 10 SEP., 66 23 DEC., 66 31 DEC., 65 WTR 1 10 SEP., 67 23 DEC., 67 31 DEC., 66 WTR 1 10 SEP., 68 23 DEC., 68 31 DEC., 67 WTR 1 10 SEP., 69 23 DEC., 69 31 DEC., 68 WTR 1 10 SEP., 70 23 DEC., 70 31 DEC., 69 WTR 1 10 SEP., 71 23 DEC., 71 31 DEC., 70 WTR 1 10 SEP., 72 23 DEC., 72 31 DEC., 71 WTR 1 10 SEP., 73 23 DEC., 73 31 DEC., 72 WTR 1 10 SEP., 74 23 DEC., 74 31 DEC., 73 WTR 1 10 SEP., 75 23 DEC., 75 31 DEC., 74 WTR 1 10 SEP., 76 23 DEC., 76 31 DEC., 75 WTR 1 10 SEP., 77 23 DEC., 77 31 DEC., 76 WTR 1 10 SEP., 78 23 DEC., 78 31 DEC., 77 WTR 1 10 SEP., 79 23 DEC., 79 31 DEC., 78 WTR 1 10 SEP., 80 23 DEC., 80 31 DEC., 79 WTR 1 10 SEP., 81 23 DEC., 81 31 DEC., 80 WTR 1 10 SEP., 82 23 DEC., 82 31 DEC., 81 WTR 1 10 SEP., 83 23 DEC., 83 31 DEC., 82 WTR 1 10 SEP., 84 23 DEC., 84 31 DEC., 83 WTR WTR WTR desmethyl­ linuron ­ 2 applications @ 0.04 kg/ ha WTR 23 WTR WTR WTR WTR WTR PESTICIDE APPLICATION INFORMATION WTR ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR CHEMICAL PESTICIDE INCORPORATION WTR PESICIDE APPLICATION APPLICATION APPLIED DEPTH WTR NAME DATE MODEL (KG/ HA) (CM) WTR WTR desmethyl­ linuron 10 DEC., 48 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 48 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 49 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 49 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 50 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 50 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 51 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 51 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 52 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 52 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 53 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 53 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 54 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 54 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 55 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 55 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 56 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 56 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 57 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 57 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 58 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 58 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 59 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 59 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 60 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 60 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 61 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 61 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 62 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 62 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 63 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 63 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 64 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 64 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 65 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 65 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 66 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 66 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 67 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 67 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 68 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 68 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 69 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 69 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 70 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 70 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 71 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 71 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 72 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 72 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 73 2 0.4000E­ 01 0.0000 24 WTR desmethyl­ linuron 24 DEC., 73 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 74 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 74 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 75 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 75 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 76 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 76 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 77 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 77 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 78 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 78 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 79 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 79 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 80 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 80 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 81 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 81 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 82 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 82 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 10 DEC., 83 2 0.4000E­ 01 0.0000 WTR desmethyl­ linuron 24 DEC., 83 2 0.4000E­ 01 0.0000 WTR WTR WTR WTR PLANT PESTICIDE PARAMETERS WTR ­­­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR WTR FOLIAR PESTICIDE DECAY RATE (/ DAY) 0.0000 WTR EXTRACTION COEFFICIENT (/ CM) 0.0000 WTR FOLIAR PESTICIDE VOLATILIZATION RATE (/ DAY) 0.0000 WTR FILTRATION PARAMETER (M** 2/ MG) 0.0000 WTR AFTER HARVEST DATE, REMAINING CHEMICAL 1 IN CANOPY IS SURFACE APPLIED WTR PLANT UPTAKE EFFICIENCY FACTOR 0.0000 WTR WTR WTR Linuron WTR WTR WTR WTR WTR WTR GENERAL SOIL INFORMATION WTR ­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR CORE DEPTH (CM) 100.0 WTR TOTAL HORIZONS IN CORE 2 WTR THETA FLAG (0= INPUT, 1= CALCULATED) 0 WTR PARTITION COEFFICIENT FLAG (0= INPUT, 1= CALCULATED) 1 WTR BULK DENSITY FLAG (0= INPUT, 1= CALCULATED) 0 WTR SOIL HYDRAULICS MODULE (0= HYDR1,1= HYDR2) 0 WTR TRANSPORT SOLUTION TECHNIQUE (0= BACKDIFF, 1= MOC) 0 WTR IRRIGATION FLAG (0= OFF, 1= ON) 0 WTR TEMPERATURE CORRECTION (0= OFF, 1= ON) 0 WTR THERMAL CONDUCTIVITY (0= SUPPLIED, 1= CALCULATED) 0 WTR BIODEGRADATION FLAG (0= OFF, 1= ON) 0 WTR WTR PESTICIDE PROPERTY INFORMATION WTR ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ WTR HENRY'S LAW CONSTANT 0.0000 WTR DIFFUSION COEFFICIENT (CM** 2/ DAY) 0.0000 WTR 25 WTR WTR WTR WTR SOIL HORIZON INFORMATION WTR ­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR INITIAL FIELD WILTING WTR SOIL CAPACITY POINT WTR BULK WATER DRAINAGE LAT DRAIN WATER WATORGANIC WTR HORI­ THICK DENSITY CONTENT PARAMETER PARAMETER CONTENT CONTENT CARBON WTR ZON (CM) (G/ CM** 3) (CM/ CM) (/ DAY) (/ DAY) (CM/ CM) (CM/ CM) (%) WTR ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR 1 18.0 1.6000 0.325 0.00 0.00 .32500 0.175 0.017 WTR 2 82.0 1.5000 0.249 0.00 0.00 .24900 0.129 0.002 WTR WTR WTR HORIZON LAYER DEPTH (CM) WTR WTR 1 1.00 WTR 2 1.00 WTR WTR desmethyl­ linuron WTR WTR HORIZON 1 WTR ­­­­­­ WTR WTR LIQUID PHASE DECAY RATE (/ DAY) 0.700E­ 02 WTR SOLID PHASE DECAY RATE (/ DAY) 0.700E­ 02 WTR GAS PHASE DECAY RATE (/ DAY) 0.000 WTR DISPERSION COEFFICIENTS (CM** 2/ DAY) 0.000 WTR WTR HORIZON 2 WTR ­­­­­­ WTR WTR LIQUID PHASE DECAY RATE (/ DAY) 0.700E­ 02 WTR SOLID PHASE DECAY RATE (/ DAY) 0.700E­ 02 WTR GAS PHASE DECAY RATE (/ DAY) 0.000 WTR DISPERSION COEFFICIENTS (CM** 2/ DAY) 0.000 WTR WTR WTR WTR PLOT FILE INFORMATION WTR ­­­­­­­­­­­­­­­­­­­­ WTR WTR NUMBER OF PLOTTING VARIABLES 7 WTR TIMSER NAME MODE CMPT BEG CMPT END CONSTANT TYPE DSN WTR WTR PRCP TCUM 0 0 0.0000 P WTR RUNF TCUM 0 0 0.0000 P WTR INFL TCUM 1 1 0.0000 P WTR ESLS TCUM 0 0 1000. P WTR RFLX TCUM 0 0 0.1000E+ 06 P 26 WTR EFLX TCUM 0 0 0.1000E+ 06 P WTR RZFX TCUM 0 0 0.1000E+ 06 P OUT 1948 12 31 24 0 0.0000 0.0000 0.0000 0.0000 OUT 1949 12 31 24 0 0.3138E­ 05 0.4691E­ 09 0.0000 0.0000 OUT 1950 12 31 24 0 0.4200E­ 05 0.1769E­ 08 0.0000 0.0000 OUT 1951 12 31 24 0 0.6374E­ 05 0.3089E­ 08 0.0000 0.0000 OUT 1952 12 31 24 0 0.5550E­ 04 0.3689E­ 07 0.0000 0.0000 OUT 1953 12 31 24 0 0.1085E­ 05 0.4396E­ 09 0.0000 0.0000 OUT 1954 12 31 24 0 0.1648E­ 03 0.1314E­ 06 0.0000 0.0000 OUT 1955 12 31 24 0 0.1462E­ 04 0.7369E­ 08 0.0000 0.0000 OUT 1956 12 31 24 0 0.5102E­ 06 0.1537E­ 09 0.0000 0.0000 OUT 1957 12 31 24 0 0.4680E­ 04 0.3116E­ 07 0.0000 0.0000 OUT 1958 12 31 24 0 0.5786E­ 06 0.2378E­ 09 0.0000 0.0000 OUT 1959 12 31 24 0 0.0000 0.0000 0.0000 0.0000 OUT 1960 12 31 24 0 0.3622E­ 04 0.2090E­ 07 0.0000 0.0000 OUT 1961 12 31 24 0 0.3295E­ 08 0.9111E­ 12 0.0000 0.0000 OUT 1962 12 31 24 0 0.1776E­ 04 0.9296E­ 08 0.2572E­ 12 0.0000 OUT 1963 12 31 24 0 0.8455E­ 04 0.5354E­ 07 0.0000 0.0000 OUT 1964 12 31 24 0 0.3775E­ 09 0.4864E­ 13 0.0000 0.0000 OUT 1965 12 31 24 0 0.1799E­ 03 0.1426E­ 06 0.0000 0.0000 OUT 1966 12 31 24 0 0.6666E­ 05 0.3252E­ 08 0.0000 0.0000 OUT 1967 12 31 24 0 0.1010E­ 03 0.7422E­ 07 0.0000 0.0000 OUT 1968 12 31 24 0 0.3431E­ 05 0.1375E­ 08 0.0000 0.0000 OUT 1969 12 31 24 0 0.8540E­ 06 0.3494E­ 09 0.1875E­ 10 0.0000 OUT 1970 12 31 24 0 0.1465E­ 04 0.7266E­ 08 0.0000 0.0000 OUT 1971 12 31 24 0 0.7705E­ 06 0.3464E­ 09 0.0000 0.0000 OUT 1972 12 31 24 0 0.3413E­ 05 0.3211E­ 08 0.0000 0.0000 OUT 1973 12 31 24 0 0.1987E­ 04 0.1077E­ 07 0.0000 0.0000 OUT 1974 12 31 24 0 0.8009E­ 05 0.3416E­ 08 0.0000 0.0000 OUT 1975 12 31 24 0 0.1499E­ 04 0.8118E­ 08 0.0000 0.0000 OUT 1976 12 31 24 0 0.1112E­ 04 0.6433E­ 08 0.0000 0.0000 OUT 1977 12 31 24 0 0.6883E­ 04 0.4340E­ 07 0.0000 0.0000 OUT 1978 12 31 24 0 0.2672E­ 05 0.1322E­ 08 0.9375E­ 07 0.0000 OUT 1979 12 31 24 0 0.7743E­ 05 0.3922E­ 08 0.0000 0.0000 OUT 1980 12 31 24 0 0.4784E­ 05 0.2111E­ 08 0.0000 0.0000 OUT 1981 12 31 24 0 0.1599E­ 04 0.9170E­ 08 0.0000 0.0000 OUT 1982 12 31 24 0 0.9103E­ 05 0.4244E­ 08 0.0000 0.0000 OUT 1983 12 31 24 0 0.1430E­ 03 0.9153E­ 07 0.0000 0.0000 IR­ PCA PRZM/ EXAMS OUTPUT FILE FOR THE USE OF DESMETHOXY LINURON ON CARROTS IN CALIFORNIA 27 Chemical: desmethoxy­ linuron PRZM environment: dsmthl1. txt EXAMS environment: IRPRZM0. EXV Metfile: met17. met Water segment concentrations (ppb) Year Peak 96 hr 21 Day 60 Day 90 Day Yearly 1948 0.3728 0.3725 0.2571 0.09312 0.06208 0.01617 1949 0.7207 0.72 0.6054 0.4439 0.4141 0.3781 1950 1.048 1.047 0.9335 0.7744 0.7457 0.7165 1951 1.358 1.354 1.241 1.084 1.056 1.035 1952 1.656 1.646 1.495 1.337 1.328 1.293 1953 1.917 1.915 1.803 1.65 1.645 1.619 1954 2.438 2.435 2.324 2.196 2.189 2.142 1955 2.646 2.643 2.533 2.425 2.417 2.374 1956 2.673 2.67 2.635 2.632 2.626 2.539 1957 2.944 2.939 2.816 2.677 2.672 2.629 1958 2.925 2.925 2.924 2.918 2.897 2.651 1959 3.023 3.02 2.91 2.817 2.811 2.763 1960 3.085 3.082 3.072 3.053 3.043 2.937 1961 3.067 3.064 2.954 2.864 2.858 2.809 1962 3.055 3.055 3.054 2.945 2.831 2.63 1963 3.001 2.998 2.888 2.838 2.826 2.752 1964 3.18 3.177 3.068 2.985 2.978 2.926 1965 3.536 3.423 3.167 3.163 3.149 3.037 1966 3.513 3.51 3.496 3.457 3.426 3.327 1967 3.688 3.684 3.628 3.613 3.597 3.483 1968 3.764 3.761 3.673 3.668 3.656 3.551 1969 3.762 3.758 3.747 3.716 3.683 3.555 1970 3.747 3.747 3.747 3.734 3.715 3.615 1971 3.743 3.739 3.73 3.725 3.717 3.563 1972 3.738 3.735 3.728 3.723 3.715 3.578 1973 3.724 3.712 3.671 3.619 3.577 3.415 1974 3.607 3.607 3.604 3.598 3.565 3.368 1975 3.495 3.492 3.383 3.331 3.32 3.256 1976 3.651 3.648 3.54 3.484 3.478 3.416 1977 3.65 3.65 3.648 3.642 3.621 3.473 1978 3.617 3.615 3.607 3.233 2.894 2.346 1979 2.66 2.657 2.547 2.439 2.432 2.389 1980 2.793 2.791 2.68 2.622 2.604 2.536 1981 2.944 2.941 2.832 2.787 2.777 2.703 1982 3.006 3.004 2.933 2.931 2.921 2.808 1983 3.087 3.081 2.939 2.923 2.914 2.821 Sorted results Prob. Peak 96 hr 21 Day 60 Day 90 Day Yearly 0.027027027 3.764 3.761 3.747 3.734 3.717 3.615 0.054054054 3.762 3.758 3.747 3.725 3.715 3.578 0.081081081 3.747 3.747 3.73 3.723 3.715 3.563 0.108108108 3.743 3.739 3.728 3.716 3.683 3.555 0.135135135 3.738 3.735 3.673 3.668 3.656 3.551 0.162162162 3.724 3.712 3.671 3.642 3.621 3.483 0.189189189 3.688 3.684 3.648 3.619 3.597 3.473 0.216216216 3.651 3.65 3.628 3.613 3.577 3.416 0.243243243 3.65 3.648 3.607 3.598 3.565 3.415 0.27027027 3.617 3.615 3.604 3.484 3.478 3.368 0.297297297 3.607 3.607 3.54 3.457 3.426 3.327 0.324324324 3.536 3.51 3.496 3.331 3.32 3.256 0.351351351 3.513 3.492 3.383 3.233 3.149 3.037 0.378378378 3.495 3.423 3.167 3.163 3.043 2.937 0.405405405 3.18 3.177 3.072 3.053 2.978 2.926 28 0.432432432 3.087 3.082 3.068 2.985 2.921 2.821 0.459459459 3.085 3.081 3.054 2.945 2.914 2.809 0.486486486 3.067 3.064 2.954 2.931 2.897 2.808 0.513513514 3.055 3.055 2.939 2.923 2.894 2.763 0.540540541 3.023 3.02 2.933 2.918 2.858 2.752 0.567567568 3.006 3.004 2.924 2.864 2.831 2.703 0.594594595 3.001 2.998 2.91 2.838 2.826 2.651 0.621621622 2.944 2.941 2.888 2.817 2.811 2.63 0.648648649 2.944 2.939 2.832 2.787 2.777 2.629 0.675675676 2.925 2.925 2.816 2.677 2.672 2.539 0.702702703 2.793 2.791 2.68 2.632 2.626 2.536 0.72972973 2.673 2.67 2.635 2.622 2.604 2.389 0.756756757 2.66 2.657 2.547 2.439 2.432 2.374 0.783783784 2.646 2.643 2.533 2.425 2.417 2.346 0.810810811 2.438 2.435 2.324 2.196 2.189 2.142 0.837837838 1.917 1.915 1.803 1.65 1.645 1.619 0.864864865 1.656 1.646 1.495 1.337 1.328 1.293 0.891891892 1.358 1.354 1.241 1.084 1.056 1.035 0.918918919 1.048 1.047 0.9335 0.7744 0.7457 0.7165 0.945945946 0.7207 0.72 0.6054 0.4439 0.4141 0.3781 0.972972973 0.3728 0.3725 0.2571 0.09312 0.06208 0.01617 0.1 3.7442 3.7414 3.7286 3.7181 3.6926 3.5574 2.623604722 SCI­ GROW output file SCIGROW VERSION 2.1 MAY 1, 2001 RUN No. 1 FOR desmethoxy linuron ** INPUT VALUES ** ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ­­­ APP RATE APPS/ TOTAL/ SOIL AEROBIC SOIL METAB (LBS/ AC) YEAR SEASON KOC HALFLIFE (DAYS) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ­­­ .080 2 .160 208.0 99.00 GROUND­ WATER SCREENING CONCENTRATION (IN PPB) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ .0942 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 29 IR­ PCA PRZM/ EXAMS INPUT FILE FOR THE USE OF NOR LINURON ON CARROTS IN CALIFORNIA WTR WTR *********************************** WTR * PESTICIDE ROOT ZONE MODEL * WTR * RELEASE 3.12 Beta * WTR * February 1998 * WTR *********************************** WTR WTR *********************************** WTR WTR DEVELOPED FOR: WTR U. S. ENVIRONMENTAL PROTECTION AGENCY WTR OFFICE OF RESEARCH AND DEVELOPMENT WTR NATIONAL EXPOSURE RESEARCH LABORATORY WTR ECOSYSTEMS RESEARCH DIVISION WTR ATHENS, GEORGIA 30605­ 2700 WTR 706/ 355­ 8328 WTR Distributed by: Des Center for Exposure Assessment Modeling WTR http:// www. epa. gov/ CEAM WTR ceam@ epamail. epa. gov WTR WTR WTR WTR SIMULATION START DATE (DAY­ MONTH­ YEAR) 1 JAN., 48 WTR SIMULATION END DATE (DAY­ MONTH­ YEAR) 31 DEC., 83 WTR WTR WTR "Lerdo clay loam, MLRA C­ 17; Central Valley, CA, Carrots" WTR WTR WTR WTR WTR WTR HYDROLOGY AND SEDIMENT RELATED PARAMETERS WTR ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR PAN COEFFICIENT FOR EVAPORATION 0.7000 WTR FLAG FOR ET SOURCE (0= EVAP, 1= TEMP, 2= EITHER) 0 30 WTR DEPTH TO WHICH ET IS COMPUTED YEAR­ ROUND (CM) 17.0000 WTR SNOW MELT COEFFICIENT (CM/ DEG­ C­ DAY) 0.5000 WTR INITIAL CROP NUMBER 1 WTR INITIAL CROP CONDITION 1 WTR WTR WTR SOIL EROSION PARAMETERS WTR ­­­­­­­­­­­­­­­­­­­­­­ WTR WTR USLE "K" PARAMETER 0.2100 WTR USLE "LS" PARAMETER 1.000 WTR USLE "P" PARAMETER 1.000 WTR FIELD OR PLOT AREA (HA) 172.0 WTR STORM TYPE 3 WTR SLOPE 1.000 WTR HYDRAULIC LENGTH (M) 600.0 WTR WTR WTR CROPPING EROSION PARAMETERS WTR ­­­­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR WTR CROP NUMBER 1 WTR NUMBER OF USLEC FACTORS 3 WTR WTR # DAY MONTH USLEC MANNINGS N WTR WTR 1 1 1 0.100 0.020 WTR 2 21 9 0.100 0.000 WTR 3 22 9 0.100 ***** WTR WTR WTR CROP INFORMATION WTR ­­­­­­­­­­­­­­­ WTR WTR MAXIMUM SURFACE WTR INTERCEPT. MAXIMUM MAXIMUM MAXIMUM CONDITION MAXIMUM WTR CROP POTENTIAL ROOT DEPTH COVER WEIGHT AFTER HEIGHT AMC RUNOFF CURVE NUMBERS WTR NUMBER (CM) (CM) (%) (KG/ M** 2) HARVEST (CM) FALLOW CROP RESIDUE WTR WTR I 80 70 75 WTR 1 0.2000 60.00 80.00 0.0000 3 100.000 II 91 85 88 WTR III 96 93 95 WTR WTR WTR CROP ROTATION INFORMATION WTR ­­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR CROP EMERGENCE MATURATION HARVEST WTR NUMBER DATE DATE DATE WTR WTR 1 10 SEP., 49 23 DEC., 49 31 DEC., 48 WTR 1 10 SEP., 50 23 DEC., 50 31 DEC., 49 WTR 1 10 SEP., 51 23 DEC., 51 31 DEC., 50 WTR 1 10 SEP., 52 23 DEC., 52 31 DEC., 51 WTR 1 10 SEP., 53 23 DEC., 53 31 DEC., 52 WTR 1 10 SEP., 54 23 DEC., 54 31 DEC., 53 31 WTR 1 10 SEP., 55 23 DEC., 55 31 DEC., 54 WTR 1 10 SEP., 56 23 DEC., 56 31 DEC., 55 WTR 1 10 SEP., 57 23 DEC., 57 31 DEC., 56 WTR 1 10 SEP., 58 23 DEC., 58 31 DEC., 57 WTR 1 10 SEP., 59 23 DEC., 59 31 DEC., 58 WTR 1 10 SEP., 60 23 DEC., 60 31 DEC., 59 WTR 1 10 SEP., 61 23 DEC., 61 31 DEC., 60 WTR 1 10 SEP., 62 23 DEC., 62 31 DEC., 61 WTR 1 10 SEP., 63 23 DEC., 63 31 DEC., 62 WTR 1 10 SEP., 64 23 DEC., 64 31 DEC., 63 WTR 1 10 SEP., 65 23 DEC., 65 31 DEC., 64 WTR 1 10 SEP., 66 23 DEC., 66 31 DEC., 65 WTR 1 10 SEP., 67 23 DEC., 67 31 DEC., 66 WTR 1 10 SEP., 68 23 DEC., 68 31 DEC., 67 WTR 1 10 SEP., 69 23 DEC., 69 31 DEC., 68 WTR 1 10 SEP., 70 23 DEC., 70 31 DEC., 69 WTR 1 10 SEP., 71 23 DEC., 71 31 DEC., 70 WTR 1 10 SEP., 72 23 DEC., 72 31 DEC., 71 WTR 1 10 SEP., 73 23 DEC., 73 31 DEC., 72 WTR 1 10 SEP., 74 23 DEC., 74 31 DEC., 73 WTR 1 10 SEP., 75 23 DEC., 75 31 DEC., 74 WTR 1 10 SEP., 76 23 DEC., 76 31 DEC., 75 WTR 1 10 SEP., 77 23 DEC., 77 31 DEC., 76 WTR 1 10 SEP., 78 23 DEC., 78 31 DEC., 77 WTR 1 10 SEP., 79 23 DEC., 79 31 DEC., 78 WTR 1 10 SEP., 80 23 DEC., 80 31 DEC., 79 WTR 1 10 SEP., 81 23 DEC., 81 31 DEC., 80 WTR 1 10 SEP., 82 23 DEC., 82 31 DEC., 81 WTR 1 10 SEP., 83 23 DEC., 83 31 DEC., 82 WTR 1 10 SEP., 84 23 DEC., 84 31 DEC., 83 WTR WTR WTR nor­ linuron ­ 2 applications @ 0.03 kg/ ha WTR WTR WTR WTR WTR WTR PESTICIDE APPLICATION INFORMATION WTR ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR CHEMICAL PESTICIDE INCORPORATION WTR PESICIDE APPLICATION APPLICATION APPLIED DEPTH WTR NAME DATE MODEL (KG/ HA) (CM) WTR WTR nor­ linuron 10 DEC., 48 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 48 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 49 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 49 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 50 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 50 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 51 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 51 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 52 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 52 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 53 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 53 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 54 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 54 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 55 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 55 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 56 2 0.3000E­ 01 0.0000 32 WTR nor­ linuron 24 DEC., 56 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 57 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 57 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 58 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 58 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 59 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 59 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 60 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 60 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 61 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 61 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 62 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 62 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 63 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 63 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 64 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 64 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 65 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 65 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 66 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 66 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 67 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 67 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 68 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 68 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 69 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 69 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 70 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 70 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 71 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 71 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 72 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 72 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 73 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 73 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 74 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 74 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 75 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 75 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 76 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 76 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 77 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 77 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 78 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 78 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 79 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 79 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 80 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 80 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 81 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 81 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 82 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 82 2 0.3000E­ 01 0.0000 WTR nor­ linuron 10 DEC., 83 2 0.3000E­ 01 0.0000 WTR nor­ linuron 24 DEC., 83 2 0.3000E­ 01 0.0000 WTR WTR WTR WTR PLANT PESTICIDE PARAMETERS WTR ­­­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR 33 WTR FOLIAR PESTICIDE DECAY RATE (/ DAY) 0.0000 WTR EXTRACTION COEFFICIENT (/ CM) 0.0000 WTR FOLIAR PESTICIDE VOLATILIZATION RATE (/ DAY) 0.0000 WTR FILTRATION PARAMETER (M** 2/ MG) 0.0000 WTR AFTER HARVEST DATE, REMAINING CHEMICAL 1 IN CANOPY IS SURFACE APPLIED WTR PLANT UPTAKE EFFICIENCY FACTOR 0.0000 WTR WTR WTR Linuron WTR WTR WTR WTR WTR WTR GENERAL SOIL INFORMATION WTR ­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR CORE DEPTH (CM) 100.0 WTR TOTAL HORIZONS IN CORE 2 WTR THETA FLAG (0= INPUT, 1= CALCULATED) 0 WTR PARTITION COEFFICIENT FLAG (0= INPUT, 1= CALCULATED) 1 WTR BULK DENSITY FLAG (0= INPUT, 1= CALCULATED) 0 WTR SOIL HYDRAULICS MODULE (0= HYDR1,1= HYDR2) 0 WTR TRANSPORT SOLUTION TECHNIQUE (0= BACKDIFF, 1= MOC) 0 WTR IRRIGATION FLAG (0= OFF, 1= ON) 0 WTR TEMPERATURE CORRECTION (0= OFF, 1= ON) 0 WTR THERMAL CONDUCTIVITY (0= SUPPLIED, 1= CALCULATED) 0 WTR BIODEGRADATION FLAG (0= OFF, 1= ON) 0 WTR WTR PESTICIDE PROPERTY INFORMATION WTR ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ WTR HENRY'S LAW CONSTANT 0.0000 WTR DIFFUSION COEFFICIENT (CM** 2/ DAY) 0.0000 WTR WTR WTR WTR WTR SOIL HORIZON INFORMATION WTR ­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR INITIAL FIELD WILTING WTR SOIL CAPACITY POINT WTR BULK WATER DRAINAGE LAT DRAIN WATER WATORGANIC WTR HORI­ THICK DENSITY CONTENT PARAMETER PARAMETER CONTENT CONTENT CARBON WTR ZON (CM) (G/ CM** 3) (CM/ CM) (/ DAY) (/ DAY) (CM/ CM) (CM/ CM) (%) WTR ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ WTR WTR 1 18.0 1.6000 0.325 0.00 0.00 .32500 0.175 0.017 WTR 2 82.0 1.5000 0.249 0.00 0.00 .24900 0.129 0.002 WTR WTR WTR HORIZON LAYER DEPTH (CM) WTR 34 WTR 1 1.00 WTR 2 1.00 WTR WTR nor­ linuron WTR WTR HORIZON 1 WTR ­­­­­­ WTR WTR LIQUID PHASE DECAY RATE (/ DAY) 0.700E­ 02 WTR SOLID PHASE DECAY RATE (/ DAY) 0.700E­ 02 WTR GAS PHASE DECAY RATE (/ DAY) 0.000 WTR DISPERSION COEFFICIENTS (CM** 2/ DAY) 0.000 WTR WTR HORIZON 2 WTR ­­­­­­ WTR WTR LIQUID PHASE DECAY RATE (/ DAY) 0.700E­ 02 WTR SOLID PHASE DECAY RATE (/ DAY) 0.700E­ 02 WTR GAS PHASE DECAY RATE (/ DAY) 0.000 WTR DISPERSION COEFFICIENTS (CM** 2/ DAY) 0.000 WTR WTR WTR WTR PLOT FILE INFORMATION WTR ­­­­­­­­­­­­­­­­­­­­ WTR WTR NUMBER OF PLOTTING VARIABLES 7 WTR TIMSER NAME MODE CMPT BEG CMPT END CONSTANT TYPE DSN WTR WTR PRCP TCUM 0 0 0.0000 P WTR RUNF TCUM 0 0 0.0000 P WTR INFL TCUM 1 1 0.0000 P WTR ESLS TCUM 0 0 1000. P WTR RFLX TCUM 0 0 0.1000E+ 06 P WTR EFLX TCUM 0 0 0.1000E+ 06 P WTR RZFX TCUM 0 0 0.1000E+ 06 P OUT 1948 12 31 24 0 0.0000 0.0000 0.0000 0.0000 OUT 1949 12 31 24 0 0.2354E­ 05 0.3518E­ 09 0.0000 0.0000 OUT 1950 12 31 24 0 0.3150E­ 05 0.1327E­ 08 0.0000 0.0000 OUT 1951 12 31 24 0 0.4780E­ 05 0.2317E­ 08 0.0000 0.0000 OUT 1952 12 31 24 0 0.4163E­ 04 0.2767E­ 07 0.0000 0.0000 OUT 1953 12 31 24 0 0.8135E­ 06 0.3297E­ 09 0.0000 0.0000 OUT 1954 12 31 24 0 0.1236E­ 03 0.9855E­ 07 0.0000 0.0000 OUT 1955 12 31 24 0 0.1096E­ 04 0.5526E­ 08 0.0000 0.0000 OUT 1956 12 31 24 0 0.3827E­ 06 0.1153E­ 09 0.0000 0.0000 OUT 1957 12 31 24 0 0.3510E­ 04 0.2337E­ 07 0.0000 0.0000 OUT 1958 12 31 24 0 0.4340E­ 06 0.1784E­ 09 0.0000 0.0000 OUT 1959 12 31 24 0 0.0000 0.0000 0.0000 0.0000 OUT 1960 12 31 24 0 0.2717E­ 04 0.1567E­ 07 0.0000 0.0000 OUT 1961 12 31 24 0 0.2471E­ 08 0.6833E­ 12 0.0000 0.0000 OUT 1962 12 31 24 0 0.1332E­ 04 0.6972E­ 08 0.1929E­ 12 0.0000 OUT 1963 12 31 24 0 0.6341E­ 04 0.4015E­ 07 0.0000 0.0000 OUT 1964 12 31 24 0 0.2831E­ 09 0.3648E­ 13 0.0000 0.0000 OUT 1965 12 31 24 0 0.1349E­ 03 0.1069E­ 06 0.0000 0.0000 OUT 1966 12 31 24 0 0.5000E­ 05 0.2439E­ 08 0.0000 0.0000 OUT 1967 12 31 24 0 0.7577E­ 04 0.5567E­ 07 0.0000 0.0000 OUT 1968 12 31 24 0 0.2573E­ 05 0.1032E­ 08 0.0000 0.0000 OUT 1969 12 31 24 0 0.6405E­ 06 0.2620E­ 09 0.1407E­ 10 0.0000 OUT 1970 12 31 24 0 0.1098E­ 04 0.5450E­ 08 0.0000 0.0000 OUT 1971 12 31 24 0 0.5779E­ 06 0.2598E­ 09 0.0000 0.0000 OUT 1972 12 31 24 0 0.2560E­ 05 0.2408E­ 08 0.0000 0.0000 OUT 1973 12 31 24 0 0.1490E­ 04 0.8077E­ 08 0.0000 0.0000 35 OUT 1974 12 31 24 0 0.6007E­ 05 0.2562E­ 08 0.0000 0.0000 OUT 1975 12 31 24 0 0.1125E­ 04 0.6089E­ 08 0.0000 0.0000 OUT 1976 12 31 24 0 0.8344E­ 05 0.4824E­ 08 0.0000 0.0000 OUT 1977 12 31 24 0 0.5162E­ 04 0.3255E­ 07 0.0000 0.0000 OUT 1978 12 31 24 0 0.2004E­ 05 0.9915E­ 09 0.7032E­ 07 0.0000 OUT 1979 12 31 24 0 0.5807E­ 05 0.2942E­ 08 0.0000 0.0000 OUT 1980 12 31 24 0 0.3588E­ 05 0.1583E­ 08 0.0000 0.0000 OUT 1981 12 31 24 0 0.1199E­ 04 0.6877E­ 08 0.0000 0.0000 OUT 1982 12 31 24 0 0.6827E­ 05 0.3183E­ 08 0.0000 0.0000 OUT 1983 12 31 24 0 0.1073E­ 03 0.6865E­ 07 0.0000 0.0000 IR­ PCA PRZM/ EXAMS OUTPUT FILE FOR THE USE OF NOR LINURON ON CARROTS IN CALIFORNIA Chemical: nor­ linuron PRZM environment: dsmthl1. txt EXAMS environment: IRPRZM0. EXV Metfile: met17. met Water segment concentrations (ppb) Year Peak 96 hr 21 Day 60 Day 90 Day Yearly 1948 0.14 0.1399 0.0966 0.03498 0.02332 0.006075 1949 0.2713 0.2711 0.228 0.167 0.1557 0.1421 1950 0.3956 0.3954 0.3524 0.292 0.2811 0.27 1951 0.514 0.5127 0.4694 0.4096 0.399 0.3912 1952 0.6277 0.6242 0.5664 0.5064 0.5027 0.4894 1953 0.7277 0.7273 0.6847 0.626 0.624 0.6139 1954 0.9261 0.9256 0.8833 0.833 0.8303 0.8126 1955 1.008 1.007 0.965 0.9224 0.9193 0.903 1956 1.021 1.02 1.005 1.004 1.002 0.9685 1957 1.126 1.124 1.077 1.023 1.021 1.005 1958 1.12 1.12 1.12 1.118 1.109 1.015 1959 1.161 1.16 1.118 1.081 1.079 1.06 1960 1.186 1.185 1.181 1.173 1.169 1.129 1961 1.181 1.18 1.138 1.103 1.1 1.081 1962 1.178 1.178 1.178 1.135 1.092 1.013 1963 1.156 1.155 1.113 1.095 1.09 1.06 1964 1.227 1.226 1.184 1.152 1.149 1.129 1965 1.363 1.32 1.224 1.222 1.217 1.173 1966 1.354 1.353 1.348 1.333 1.321 1.282 1967 1.423 1.422 1.399 1.393 1.387 1.343 1968 1.455 1.454 1.419 1.417 1.412 1.371 1969 1.457 1.456 1.451 1.438 1.426 1.376 1970 1.453 1.453 1.453 1.448 1.44 1.401 1971 1.453 1.453 1.449 1.447 1.443 1.383 36 1972 1.453 1.453 1.45 1.448 1.445 1.391 1973 1.45 1.445 1.429 1.409 1.392 1.329 1974 1.405 1.405 1.404 1.402 1.389 1.312 1975 1.361 1.361 1.319 1.298 1.294 1.268 1976 1.423 1.422 1.381 1.359 1.356 1.332 1977 1.425 1.424 1.424 1.421 1.413 1.355 1978 1.41 1.41 1.407 1.261 1.128 0.9146 1979 1.034 1.033 0.991 0.9499 0.9469 0.93 1980 1.085 1.085 1.043 1.021 1.014 0.9867 1981 1.144 1.143 1.101 1.084 1.08 1.051 1982 1.168 1.168 1.141 1.14 1.136 1.092 1983 1.196 1.194 1.141 1.135 1.132 1.095 Sorted results Prob. Peak 96 hr 21 Day 60 Day 90 Day Yearly 0.027027027 1.457 1.456 1.453 1.448 1.445 1.401 0.054054054 1.455 1.454 1.451 1.448 1.443 1.391 0.081081081 1.453 1.453 1.45 1.447 1.44 1.383 0.108108108 1.453 1.453 1.449 1.438 1.426 1.376 0.135135135 1.453 1.453 1.429 1.421 1.413 1.371 0.162162162 1.45 1.445 1.424 1.417 1.412 1.355 0.189189189 1.425 1.424 1.419 1.409 1.392 1.343 0.216216216 1.423 1.422 1.407 1.402 1.389 1.332 0.243243243 1.423 1.422 1.404 1.393 1.387 1.329 0.27027027 1.41 1.41 1.399 1.359 1.356 1.312 0.297297297 1.405 1.405 1.381 1.333 1.321 1.282 0.324324324 1.363 1.361 1.348 1.298 1.294 1.268 0.351351351 1.361 1.353 1.319 1.261 1.217 1.173 0.378378378 1.354 1.32 1.224 1.222 1.169 1.129 0.405405405 1.227 1.226 1.184 1.173 1.149 1.129 0.432432432 1.196 1.194 1.181 1.152 1.136 1.095 0.459459459 1.186 1.185 1.178 1.14 1.132 1.092 0.486486486 1.181 1.18 1.141 1.135 1.128 1.081 0.513513514 1.178 1.178 1.141 1.135 1.109 1.06 0.540540541 1.168 1.168 1.138 1.118 1.1 1.06 0.567567568 1.161 1.16 1.12 1.103 1.092 1.051 0.594594595 1.156 1.155 1.118 1.095 1.09 1.015 0.621621622 1.144 1.143 1.113 1.084 1.08 1.013 0.648648649 1.126 1.124 1.101 1.081 1.079 1.005 0.675675676 1.12 1.12 1.077 1.023 1.021 0.9867 0.702702703 1.085 1.085 1.043 1.021 1.014 0.9685 0.72972973 1.034 1.033 1.005 1.004 1.002 0.93 0.756756757 1.021 1.02 0.991 0.9499 0.9469 0.9146 0.783783784 1.008 1.007 0.965 0.9224 0.9193 0.903 0.810810811 0.9261 0.9256 0.8833 0.833 0.8303 0.8126 0.837837838 0.7277 0.7273 0.6847 0.626 0.624 0.6139 0.864864865 0.6277 0.6242 0.5664 0.5064 0.5027 0.4894 0.891891892 0.514 0.5127 0.4694 0.4096 0.399 0.3912 0.918918919 0.3956 0.3954 0.3524 0.292 0.2811 0.27 0.945945946 0.2713 0.2711 0.228 0.167 0.1557 0.1421 0.972972973 0.14 0.1399 0.0966 0.034980.02332 0.006075 0.1 1.453 1.453 1.4493 1.4407 1.4302 1.3781 1.01316875 37 SCI­ GROW output file SCIGROW VERSION 2.1 MAY 1, 2001 RUN No. 1 FOR nor linuron ** INPUT VALUES ** ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ APP RATE APPS/ TOTAL/ SOIL AEROBIC SOIL METAB (LBS/ AC) YEAR SEASON KOC HALFLIFE (DAYS) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ .030 2 .060 208.0 99.00 GROUND­ WATER SCREENING CONCENTRATION (IN PPB) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ .0353 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 38

epa

2024-06-07T20:31:41.890047

regulations

EPA-HQ-OPP-2002-0079-0010

Supporting & Related Material

1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES 01/ 15/ 2002 MEMORANDUM SUBJECT: Linuron. Anticipated Residues and Dietary Exposure Assessment (PC Code 035506); DP Barcode D279340; Case 0047. FROM: John S. Punzi, Ph. D., Chemist Reregistration Branch II Health Effects Division (7509C) THROUGH: Alan Nielsen, Branch Senior Scientist Reregistration Branch II Health Effects Division (7509C) Dietary Exposure Science Advisory Council (DE SAC) 12/ 20/ 2001 Chemistry Science Advisory Council (DE SAC) 12/ 19/ 2001 Health Effects Division (7509C) TO: Carol Christensen, Risk Assessor Reregistration Branch II Health Effects Division (7509C) Executive Summary This exposure assessment was conducted for the herbicide linuron to estimate the dietary risk associated with registered uses of this product. A refined tier 3 analysis was done for the chronic assessment and a refined tier 3 probalistic analysis was perfomed for the acute assessment. Residue levels from USDA and FDA monitoring programs do not include all residues of concern needed for this assessment (linuron and metabolites converted to 3,4­ dichloroanaline) and would underestimate residue values for this analysis. Anticipated residues (ARs) were computed from field trial data and subsequently utilized to estimate the dietary exposure to linuron from the diets of the U. S. population, as well as certain population subgroups. In addition to percent crop treated (% CT) data, residue reduction data from 2 washing, cooking and various processing studies were used as refinements to the residue data. USDA PDP data shows that up to 70% of the carrot samples have detectable residues of linuron up to 0.3 ppm. This suggests that the ARs used for this assessment are not unrealistic. Estimated chronic dietary exposure associated with the use of linuron does not exceed HED's level of concern (> 100% cPAD 1 ) for the U. S. population or any population subgroup examined. The chronic dietary risk estimates for the US population and children aged 1­ 6 years (the highest exposed group) are approximately 15 % and 35 % of cPAD, respectively. Approximately 30 % of the chronic exposure to linuron from food is from meats and milk however the ARs for these foods are based on extremely conservative livestock diets. Estimates for acute dietary exposures associated with the use of linuron does not exceed HED's level of concern (> 100% aPAD 1 at the 99 th percentile) for the population subgroup comprised of females aged 13 to 50 years. The acute dietary risk exposure estimate for this population is approximately 10 % of aPAD. Approximately 37 % of the acute exposure to linuron from food is from asparagus and milk. As stated above the AR for milk is extremely conservative. 1 cPAD/ aPAD= acute/ chronic Population Adjusted Dose= Acute or Chronic RfD FQPA Safety Factor The data and results for this analysis are organized into 9 Sections with 4 Appendices; 1. DEEM™ Program and Consumption Information 2. Anticipated Residues 3. Crop Use Information and Field Trial Data 4. Processing Studies 5. Residue Reduction 6. Residues in Meat and Milk 7. Toxicology Data 8. Chronic Exposure Results 9. Acute Exposure Results Appendix 1; Residue Distribution Files (asparagus. rdf, carrot. rdf, celery. rdf, parsely. rdf, potato. rdf, sweetcorn. rdf). Appendix 2; Chronic DEEM input files (linuron_ chronic. rs7, linuron_ chronic. CH1). Appendix 3; Acute DEEM input files (linuron_ acute. rs7, linuron_ acute. AC1) Appendix 4; BEAD % Crop Treated Data. 1. DEEM™ Program and Consumption Information 3 Linuron acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model (DEEM™) software Version 7.73, which incorporates consumption data from USDA's Continuing Surveys of Food Intake by Individuals (CSFII), 1989­ 1992. The 1989­ 92 data are based on the reported consumption of more than 10,000 individuals over three consecutive days, and therefore represent more than 30,000 unique person days of data. Foods as consumed (e. g., apple pie) are linked to raw agricultural commodities and their food forms (e. g., apples­ cooked/ canned or wheat­ flour) by recipe translation files internal to the DEEM software. Consumption data are averaged for the entire U. S. population and within population subgroups for chronic exposure assessment, but are retained as individual consumption events for acute exposure assessment. For chronic exposure and risk assessment, an estimate of the residue level in each food or food­ form (e. g., orange or orange­ juice) on the commodity residue list is multiplied by the average daily consumption estimate for that food/ food form. The resulting residue consumption estimate for each food/ food form is summed with the residue consumption estimates for all other food/ food forms on the commodity residue list to arrive at the total estimated exposure. Exposure estimates are expressed in mg/ kg body weight/ day and as a percent of the cPAD. This procedure is performed for each population subgroup. For acute exposure assessments, individual one­ day food consumption data are used on an individual­ byindividual basis. The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic (Tier 1 or Tier 2) exposure assessment, or matched in multiple random pairings with residue values and then summed in a probabilistic (Tier 3/ 4) assessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i. e., those who reported eating relevant commodities/ food forms) and a percapita (i. e., those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis. However, for tiers 1 and 2, significant differences in user vs. per capita exposure and risk are identified and noted in the risk assessment. 2. Anticipated Residues Table 1 Residue data to be used in exposure calculations. Crop Tolerence Percent of Crop Treated Anticipated Residue s 1 Processing/ Reduction factor( s) Average Maximum Chronic Acute Asparagus 7.0 20 33 0.541750 0.893888b 2 RDF1 nb, pb Washing (0.4) 3 Boiled (0.25) Carrot 1.0 75 100 0.276250 0.368333b RDF2 nb, pb Boiled (0.35) 4 Celery 0.5 24 33 0.030150 0.041456b RDF3 nb, pb Boiled (0.35) Corn, grain 0.01 1 1 0.000633 0.000633 oil 1x bran 1x flour 1x Boiled (0.35) Corn, sweet 0.25 1 1 0.000138 0.000138b RDF4 nb, pb Boiled (0.35) Cotton 0.05 1 2 0.000500 0.000500 meal 1x oil 1x Parsley 0.25 3 6 0.003400 0.006800b RDF5 nb, pb Boiled (0.35) Parsnip 0.05 2 3 0.001000 0.001500b RDF6 nb, pb Boiled (0.35) Potato 0.20 7 11 0.003700 0.005814b RDF7 nb, pb Baked (1.5x) Boiled (0.48) Sorghum 0.25 1 1 0.002500 0.002500 Boiled (0.35) Soybean 1.0 1 1 0.002796 0.002796 oil (0.2) meal (1.2) tofu (0.3) Boiled (0.35) Wheat 0.05 1 1 0.000450 0.000450 bran 1x flour 1x germ 1x Boiled (0.35) Beef­ lean 0.10 NA 100 0.012567 0.067391 NA Beef­ fat 0.20 NA 100 0.085405 0.114493 NA Beef­ liver 0.10 NA 100 0.337838 1.775362 NA Pork­ lean 0.05 NA 100 0.002435 0.003039 NA Pork­ fat 0.05 NA 100 0.004136 0.005130 NA Pork­ liver 0.01 NA 100 0.065445 0.081169 NA Milk 0.05 NA 100 0.010000 0.053623 boiled 0.35 5 footnotes: 1. The anticipated residues have been corrected for % CT in this Table. 2. b =blended, nb= not blended, pb= partially blended. 3. Washing factor from asparagus study was applied to asparagus only since washing study from celery did not show residue reduction. 4. An average boiling factor was derived from asparagus, carrot and potato cooking studies and translated to all appropriate food forms (exception of meats). 3. Crop Use Information and Field Trial The reregistration requirements for magnitude of the residue in plants are fulfilled for asparagus, carrots; field corn grain; field corn forage and fodder; cottonseed; parsley; parsnips; potatoes; sorghum grain; sorghum aspirated grain fractions; soybeans; soybean forage and hay; soybean aspirated grain fractions; and wheat grain. The reregistration requirements for magnitude of the residue in plants are not fulfilled for: celery; corn, field, aspirated grain fractions; corn, sweet (K+ CWHR); corn, sweet, forage; corn, sweet, stover; cotton gin byproducts; sorghum forage and stover; wheat forage, hay, and straw. The unsatisfied data requirements are generally either storage stability information or additional geographic representation. The data collection method for linuron and metabolites of concern involves hydrolysis of the sample and measurement of 3,4­ DCA. The analytical methods used by monitoring programs rely on methods that will detect only the parent linuron compound. Since the MARC has determined that linuron and compounds hydrolyzable to 3,4­ DCA are the residues of concern the monitoring programs (USDA, FDA) do not collect the appropriate data. It is noteworthy that parent linuron was detected in nearly 70 % of the carrot samples from 1999 USDA PDP sampling program and that values up to 0.3 ppm have been measured. This indicates that the ARs generated herein are not unrealistically high. Root and Tuber Vegetables Group Carrot: Data from carrot field trials (MRID 40537601) indicate that linuron residues ranged from 0.28­ 0.50 ppm and 0.30­ 0.60 ppm in/ on samples of washed and unwashed carrots, respectively, harvested 14 days following either a single postemergence application of a 50% WP or 50% DF formulation at 2.0 lb ai/ A (1x the maximum seasonal application rate) or two applications for a total rate of 2.0 or 4.0 lb ai/ A (1x or 2x the maximum seasonal application rate). Data for anticipated residues are from 6 unwashed carrot samples; (0.30, 0.28, 0.40, 0.50, 0.39, 0.34 ppm). The residue value to be used for chronic and acute assessments for blended food forms is; (0.30 + 0.28 + 0.40 + 0.50 + 0.39 + 0.34)/ 6 * % CT= 0.368333(% CT) ppm. Note that the % CT value is an estimated maximum for acute assessment and a weighted average for the chronic assessment. The rdf file to be used in the acute exposure assesment for 6 non blended and partially blended food forms contains the residue values only since the maximum % CT is 100%. Parsnip: Data from 6 parsnip field trials (MRID 00018171) indicate that the linuron residues of concern were <0.05 ppm in/ on parsnips harvested 155, 169, and 182 days following a single application of the 50% WP at 1.0 or 2.0 lb ai/ A (0.7x or 1.3x the maximum seasonal rate). Linuron residues of concern were nondetectable (< 0.05 ppm). In the absence of reliable analytical data concerning the limits of detection (LOD), the residue value to be used for chronic assessments is; (0.05 + 0.05 + 0.05 + 0.05 + 0.05 + 0.05)/ 6 * % CT= 0.050000(% CT) ppm. The rdf file to be used in the acute exposure assesment for non blended and partially blended food forms contains the residue values and 194 zeros to reflect 3% CT. Potato: Data from 7 potato field trials (MRID 00163267) indicate that residues were nondetectable (< 0.05 ppm) in/ on all but one sample (0.07 ppm) of potato harvested 125 to 155 days after planting. A single preeemergence or postemergence application of the WP or DF formulation was made at 1.0­ 4.0 lb ai/ A (0.5­ 2x the maximum seasonal application rate) using ground equipment. Data for anticipated residues are; 0.05, 0.05, 0.05, 0.05, 0.05, 0.05, 0.07 ppm. The residue value to be used for chronic and acute assessments for blended food forms is; (0.05 + 0.05 + 0.05 +0.05 + 0.05 + 0.05 +0.07)/ 7* % CT= 0.052857(% CT) ppm. The rdf file to be used in the acute exposure assesment for non blended and partially blended food forms contains the residue values and 57 zeros to reflect 11% CT. Leafy Vegetables Group Celery: Residue data from celery field trials (MRID 41501501) indicate that linuron residues of concern were 0.04­ 0.42 ppm in/ on six celery samples harvested 68­ 102 days following a single posttransplant application of the 4 lb/ gal FlC or 50% DF formulation at 1.5 lb ai/ A (1x the maximum seasonal rate) in tests performed in FL, MI, and NY. Data from additional celery field trials (MRID 40537601) indicate that linuron residues of concern were nondetectable (< 0.05 ppm) to 0.32 ppm in/ on celery (washed/ unwashed and trimmed /untrimmed) harvested 44­ 82 days following postemergence application of either the 4 lb/ gal FlC, 50% WP, or 50% DF formulation at (i) 0.5­ 1.5 lb ai/ A (0.33­ 1x the maximum single application rate) and (ii) two or four applications at consecutive intervals of 22, 13, and 19 days for a total seasonal rate of 1.5 or 3.0 lb ai/ A (1 or 2x the maximum registered seasonal rate) in tests performed in CA, FL, and MI. Currently, the Griffin labels for the 4 lb/ gal FlC and 50% DF formulation permit use on celery in all states including CA. Griffin Corporation submitted Interregional Research Project No. 4 (IR­ 4) residue data (MRID 43681401) in support of a request for amended use of the 4 lb/ gal FlC and 50% DF formulations on celery grown west of the Rocky Mountains. Linuron residues of concern were 0.04­ 0.12 ppm in/ on celery grown in CA or OR and harvested 66 or 77 days following posttransplant application at 1.5 lb ai/ A (1x the maximum seasonal rate for all states except CA; 1.5x the maximum seasonal rate for CA). The data for the anticipated residues are taken from MRIDs 40537601, 43681401, and 41501501 and 7 reflect 1.5 lb/ ai/ A and PHI range of 60­ 83 days. Data for anticipated residues are; 0.08, 0.07, 0.10, 0.12, 0.05, 0.06, 0.04, 0.04, 0.12, 0.14, 0.42, 0.18, 0.32, 0.17, <0.05, <0.05 ppm. The residue value to be used for chronic and acute assessments for blended food forms is; (0.08 + 0.07 + 0.10 + 0.12 + 0.05 + 0.06 + 0.04 + 0.04 + 0.12 + 0.14 + 0.42 + 0.18 + 0.32 + 0.17 + 0.05 + 0.05)/ 16*% CT= 0.125625(% CT) ppm. The rdf file to be used in acute exposure assesment for non blended and partially blended food forms contains the 16 residue values and 17 zeros. Parsley: Data reported in MRID 41189801 indicate that linuron residues of concern from a single preemergence application at 1x were 0.08­ 0.11 ppm in/ on samples of parsley harvested 52­ 90 days after treatment. Linuron residues of concern from a single preemergence plus a postemergence application at 1.3x total were 0.09­ 0.18 ppm in/ on parsley 24 days after the last application. Data for anticipated residues are; 0.08, 0.18, 0.08, 0.12, 0.11, 0.11 ppm. The residue value to be used for chronic and acute assessments for blended food forms is; (0.08, 0.18, 0.08, 0.12, 0.11, 0.11)/ 6* (% CT)= 0.113333(% CT) ppm. The rdf file to be used in the acute exposure assesment for non blended and partially food forms contains the 6 residue values and 94 zeros. Legume Vegetables Group Soybean: Data reported in MRID 43039101 indicate that the linuron residues of concern from were <0.01­ 1.0 ppm in/ on 9 samples of soybeans harvested 56­ 132 days following a single preemergence application of the DF formulation at 2.5 lb ai/ A followed by a single directed postemergence application at 1.0 lb ai/ A for a total rate of 3.5 lb ai/ A (-1x the maximum seasonal rate). Data for anticipated residues are; 0.31, 0.29, 0.31, 0.23, 0.087, 0.11, 0.10, 0.80 ppm. The residue value to be used for chronic and acute assessments for the blended food forms is; (0.31, 0.29, 0.31, 0.23, 0.087, 0.11, 0.10, 0.80)/ 8* (% CT)= 0.279625(% CT) ppm. Cereal Grain Group Corn, field, grain: Data from field corn grain field trial (MRID 40537601) indicate that linuron residues were nondetectable (< 0.05 ppm) to 0.11 ppm in/ on five samples of field corn grain harvested between 47 and 116 days following a single postemergence application of the 4 lb/ gal FlC formulation at 1.5 lb ai/ A (1x the maximum application rate). Corn field trial data (MRIDs 00018171, 00018206, and 40210901) indicate that linuron residues were: (i) nondetectable (< 0.05 ppm) in/ on corn grain harvested 56­ 65 days following a single postemergence application of the WP formulation at 0.75­ 6.0 lb ai/ A; and (ii) nondetectable (< 0.05 ppm) in/ on corn grain harvested 116­ 125 days following a single preemergence application of the WP formulation at 1.5 lb ai/ A. One sample of corn harvested 150 days following 0.75 lb/ ai /A (0.5x) showed detectable residues (0.06 8 ppm). Data for anticipated residues are; 8@< 0.05, 0.11,0.09,0.10,0.06, ppm. The residue value to be used for chronic and acute assessments for the blended food forms is; (( 8* 0.05)+ 0.11 + 0.09 + 0.10 + 0.06)/ 12* (% CT)= 0.063333(% CT) ppm. Corn, sweet (K+ CWHR): Crop field trial data for sweet corn were submitted by Griffin; these data are inadequate to fulfill reregistration requirements because of incomplete geographic representation. Although inadequate, the field trial data indicate that linuron residues of concern were below the LOQ (< 0.01 ppm) to 0.048 ppm in/ on sweet corn K+ CWHR harvested at maturity following a single soil directed application of the 50% DF or 4 lb/ gal FlC formulation at 1.48­ 1.57 lb ai/ A (~ 1x the maximum application rate) made when sweet corn plants were at least 15 inches tall. Data for anticipated residues are; 16@< 0.01, 0.048, 0.04, ppm. The residue value to be used for chronic and acute assessments for the blended food forms is; (( 16* 0.01)+ 0.048 + 0.04)/ 18* (% CT)= 0.013777(% CT) ppm. The rdf file to be used in acute exposure assessment for non blended and partially blended food forms contains the 18 residue values and 1584 zeros. Sorghum: Since linuron is used on less than 1% of the US sorghum crop the tolerance of 0.25 ppm (corrected for % CT) will be used. Wheat, grain: There are three linuron EPs (EPA Reg. Nos. 1812­ 245, 19713­ 97, and 51036­ 78) currently registered for use on winter wheat (drill planted) in ID, OR, and WA.. Data reported in MRID 42605901 indicate that the linuron residues of concern were nondetectable (< 0.03 ppm to 0.08 ppm) in/ on two samples of wheat grain harvested 128 days following a single postemergence application of the DF formulation at 2.5 or 5.0 lb ai/ A (1.4x or 2.9x the maximum seasonal rate for areas west of the Cascade Range and 3.3x or 6.7x the maximum seasonal rate for areas east of the Cascade Range). Data for anticipated residues are; 4@ 0.03, 5@ 0.05, 0.08 ppm. The residue value to be used for chronic and acute assessments for the blended food forms is; (( 4* 0.03)+ 5*( 0.05) + 0.08)/ 10* (% CT)= 0.045(% CT) ppm. Miscellaneous Commodities Asparagus: Residure data for asparagus (MRID 41452601) indicate that linuron residues of concern were 0.4­ 5.0 ppm in/ on asparagus harvested 1 day following four applications (one at preemergence, a second at early emergence, followed by two postemergence applications) at 1.0 lb ai/ A/ application for a total rate of 4.0 lb ai/ A (1x the maximum seasonal rate) of L or DF formulations. Data for anticipated residues are from 8 samples; 6.75, 5.95, 1.74, 1.74, 1.13, 0.86, 2.0, 1.5 ppm. The residue value to be used for chronic and acute assessments for blended food forms is; (6.75 + 5.95 + 1.74 + 1.74 + 1.13 + 0.86 + 2.0 + 1.5)/ 8 (*% CT)= 2.708750 (% CT) ppm. The rdf file to be used in the acute exposure assessment for non blended and partially blended food forms contains the residue values and 17 zeros. 9 Cotton, seed: Since linuron is used on less than 1% of the U. S. cotton crop the tolerance of 0.05 ppm (corrected for % CT) will be used. 4. Processing Studies The reregistration requirements for the magnitude of the residue in processed food/ feed are fulfilled for field corn, cotton, soybeans, and wheat. Corn, field: An acceptable field corn processing study has been submitted (MRID 42560001). The data indicate that linuron residues of concern do not concentrate in starch, grits, meal, flour, or crude or refined oil (from both wet and dry milling) processed from field corn grain bearing trace residues following treatment at 5x. Cotton: Acceptable residue data are available for cotton processed commodities (DP Barcode D271950). No concentration of linuron residues of concern was observed in cotton meal, hulls, and refined oil processed from cottonseed bearing detectable linuron residues of concern. Potato: The processing data indicate that linuron residues of concern concentrate in wet peel waste (processing factor of 5.5x), chips (2.0x), dehydrated granules (3.4x), and oven­ baked potatoes (2.1x) but do not concentrate in peeled potato (0.82x) or mashed potato (0.61x). Sorghum, grain: Sorghum processing data (DP Barcode D187993, 11/ 18/ 93, D. McNeilly) indicate that linuron residues of concern do not concentrate in sorghum flour (processing factor of <0.44x) or starch (< 0.44x). Soybean: The available soybean processing data ( DP Barcode D182595) indicate that linuron residues of concern do not concentrate significantly in hulls (processing factor of 0.5x), meal (1.2x), soapstock (0.7x), crude oil (0.2x), refined oil (0.2x), degummed oil (0.2x), tofu (0.3x), light impurities (0.9x), soybean milk (0.15x), or soybean kernels (0.9x). Residues were found to concentrate in soybean isolate (1.6x) and lecithin (2.3x). Wheat: HED granted a waiver for a wheat processing study for linuron (DP Barcode D185892, 1/ 15/ 93, R. Perfetti) based on the fact that linuron residues of concern were below the LOQ (< 0.03 ppm) in/ on wheat grain treated at an exaggerated rate of 6.7x. 5. Reduction of Residues All data for reduction of residues have been evaluated and deemed adequate except that additional information is required to upgrade existing potato and carrot cooking studies. The asparagus cooking study shows washing with water reduces residues by 40%. Boiling removes an 10 additional 25% of the residues, while steaming had little or no effect on reducing residue levels in or on asparagus (D182590, 3/ 18/ 93, D. McNeilly). A carrot cooking study indicated that linuron residues of concern concentrate in peels (3.3x) but reduce after boiling (0.3x) or steaming (0.4x). Additional information pertaining to how the carrots were cooked and how the LOQs were determined is required to upgrade this study (D181455, 9/ 8/ 92, S. Knizner). The potato cooking study shows that linuron residues concentrate in oven­ baked potatoes (1.5x) and microwave­ baked potatoes (1.6x), but are reduced in boiled potatoes (0.48x). Additional information pertaining to the cooking procedures, LOQ determination, and sample handling/ storage is required to upgrade this study (D181454, 9/ 2/ 92, S. Knizner). The appropriate reduction factor will be used in the DEEM input files. For commodities not specifically tested a boiling factor will be employed using an average of the three cooking studies listed above (0.35x). 6. Residues in Meat and Milk Two cows were fed 50 ppm linuron (6.9x) for 30 days. Residues were 12.0 and 13.0 ppm in kidney, 11.0 and 13.0 in liver, 0.45 and 0.48 ppm in lean muscle, and 0.48 and 1.10 ppm in subcutaneous fat. Milk residues were 0.05­ 0.37 ppm, with the highest value observed on Day 27 of dosing; milk samples were collected every other day during dosing (MRID 00018210). Tolerances are not required for poultry. Table 2 Cattle diet for acute exposure assessment (6.9x): Feed Item % Dry Matter % Diet Residues Contibution (ppm) Carrot, culls 12 25 1.00 2.08 Corn, sweet, forage 48 40 3.00* 2.50 Cotton, gin byproducts 90 20 9.00* 2.00 Cottonseed, meal 89 15 0.10 0.017 Total 6.60 *Estimated tolerance (additional field trial data required). Anticipated residues for acute exposure assessments were computed as follows; Fat (0.48+ 1.10)/ 2 / 6.9= 0.114493 ppm Muscle (0.45+ 0.48)/ 2 /6.9 = 0.067391ppm. Liver/ kidney (12.0+ 13.0+ 11.0+ 13.0)/ 4/ 6.9= 1.775362ppm. Milk 0.37/ 6.9= 0.053623 ppm 11 Table 3 Cattle diet for chronic exposure assessment (37x). Feed Item % Dry Matter % Diet Residues Contibution (ppm) Carrot, culls 12 25 0.368333 0.767354 Corn, sweet, forage 48 40 0.277139 0.230949 Cotton, gin byproducts 90 20 1.491475 0.331439 Cottonseed, meal 89 15 0.10 0.017 Total 100 1.34672 Fat (0.48+ 1.10)/ 2 /37= 0.085405 ppm Muscle (0.45+ 0.48)/ 2 /37 =0.012567 ppm. Liver/ kidney (12.0+ 13.0+ 11.0+ 13.0)/ 4/ 37= 0.337838 ppm. Milk 0.37/ 37= 0.010000 These values are used for: liver, kidney, meat byproducts, and other organ meats of beef, goat, horses, sheep, and veal. Table 4 Swine diet for acute exposure assessment (153x). Feed Item Carrot, culls NA 10 1.0 0.10 Sorghum, grain NA 90 0.25 0.225 Total 100 0.325 Fat (0.48+ 1.10)/ 2 /153= 0.005163 ppm Muscle (0.45+ 0.48)/ 2 /153 = 0.003039 ppm. Liver/ kidney (12.0+ 13.0+ 11.0+ 13.0)/ 4/ 153= 0.080065 ppm. Table 5 Swine diet for chronic exposure assessment (191x). Feed Item Carrot, culls NA 10 0.368333 0.036833 Sorghum, grain NA 90 0.25 0.225 Total 100 0.261833 Fat (0.48+ 1.10)/ 2 /191= 0.004136 ppm Muscle (0.45+ 0.48)/ 2 /191= 0.002435 ppm. Liver/ kidney (12.0+ 13.0+ 11.0+ 13.0)/ 4/ 191= 0.065445 ppm. 12 7. Toxicology Data On September 13 and 27, 2001 the Hazard Identification Assessment Review Committee (HIARC) reviewed the toxicology data base of linuron and selected endpoints/ doses for various exposure assessments. The HIARC also evaluated the potential for increased susceptibility of infants and children from exposure to linuron as required by the Food Quality Protection Act (FQPA) of 1996. The doses and toxicological endpoints selected for various exposure scenarios are summarized below (HED DOC. No. 0050286). Table 6 Toxicology data. EXPOSURE SCENARIO DOSE (mg/ kg/ day) ENDPOINT STUDY Acute Dietary (Females 13­ 50) NOAEL= 12.1 UF = 100 Increased post­ implantation loss and fetal/ litter resorptions at 49.8 mg/ kg/ day (LOAEL). Rat Prenatal Developmental Toxicity (MRID 00018167) Acute RfD (Females 13­ 50 years old) = 0.121 mg/ kg Acute Dietary (General Population) No appropriate effects attributed to a single exposure was identified. Chronic Dietary NOAEL = 0.77 UF = 100 Increased met­ and sulfhemoglobin levels at LOAEL (4.17 mg/ kg/ day, males; 3.49 mg/ kg/ day, females). Chronic Oral / Dog (MRID 40952601) Chronic RfD = 0.0077 mg/ kg/ day The FQPA committee met on 11/ 26/ 2001 and reduced the safety factor to 3x for acute dietary and retained a 10x safety factor for chronic exposure assessment. The cPAD and aPAD are: 12.1 mg/ kg/ 300= 0.0403333 mg/ kg and 0.77 mg/ kg/ 1000= 0.00077 mg/ kg respectively (TXR No. 0050322). The rationale for requiring the FQPA Safety Factor is listed below; 1. A qualitative increase in susceptibility seen in the F1 males in the rat reproductive toxicity study. 2. A developmental neurotoxicity study in rats is required for the chemical because linuron is a potential endocrine disruptor and there is evidence for testicular lesions and decreased fertility in the rat reproductive toxicity study. 3. The toxicology database is complete; 4. The dietary (food and water) exposure assessments will not underestimate the potential exposures for infants, children, and/ or women of childbearing age; and, 5. There are no residential uses. 13 8. Results The chronic exposure to linuron from the diets of the U. S. population and a number of populations was computed using the latest version of DEEM, anticipated residues discribed above, 1989­ 1992 USDA consumption data and current percent crop treated data provided by BEAD. These results are presented in Table 4. Estimated chronic dietary exposure associated with the use of linuron does not exceed HED's level of concern (> 100% cPAD) for the US population or any population subgroup examined. The chronic dietary risk estimates for the US population and children aged 1­ 6 years (the highest exposed group) are approximately 15 % and 35 % of cPAD, respectively. Approximately 30 % of the chronic exposure to linuron from food is from meats and milk. The AR for meats and milk are based on an extremely conservative animal diets and is likely overestimated. Table 7. The chronic exposure of linuron from the diets for a variety of subpopoulations. Population subgroup Exposure (mg/ kg/ day) % cPAD U. S. Population (total) 0.000114 14.8 Infants (< 1 year) 0.000179 23.3 Children 1­ 6 yrs 0.000268 34.7 Children 7­ 12 yrs 0.000173 22.4 Females 13­ 50 yrs 0.000083 10.8 Males 13­ 19 yrs 0.000102 13.2 Males 20+ yrs 0.000088 11.4 Seniors 55+ 0.000094 12.2 The acute exposure to linuron from the diet for a subgroup of the U. S. population was computed using a Monte­ Carlo approach with 1000 iterations in the latest version of DEEM, anticipated residues discribed above, 1989­ 1992 USDA consumption data and current percent crop treated data provided by BEAD. These results are presented in Table 5. Estimates for acute dietary exposures associated with the use of linuron does not exceed HED's level of concern (> 100% aPAD) for the population subgroup comprised of 14 females aged 13 years to 50 years. The acute dietary risk exposure estimate for this population is approximately 10 % of aPAD. Approximately 37 % of the acute exposure to linuron from food is from asparagus and milk. The AR for milk is based on an extremely conservative animal diet and is likely overestimated. Table 8. Acute dietary exposure of linuron from the diets for a variety of subpopoulations. Population subgroup 95 th percentile 99 th percentile 99.9 th percentile exposure (mg/ kg/ day) %aPAD exposure (mg/ kg/ day) %aPAD exposure (mg/ kg/ day %aPAD Females 13­ 50 yrs 0.000605 1.50 0.001177 2.92 0.003839 9.52 Appendix 1; Residue Distribution Files (asparagus. rdf, carrot. rdf, celery. rdf, parsely. rdf, potato. rdf, sweetcorn. rdf). Appendix 2; Chronic DEEM input files (linuron_ chronic. rs7, linuron_ chronic. AC1). Appendix 3; Acute DEEM input files (linuron_ acute. rs7, linuron_ acute. AC1) Appendix 4; BEAD % Crop Treated Data. Asparagus. rdf totalnz= 8 totalz= 17 totallod= 0 lodres= 0.05 6.75 5.95 1.74 1.74 1.13 0.86 2.0 1.5 End of File (EOF) Parsnip. rdf totalnz= 6 15 totalz= 194 totallod= 0 lodres= 0.05 0.05 0.05 0.05 0.05 0.05 0.05 EOF Potato. rdf totalnz= 7 totalz= 57 totallod= 0 lodres= 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.07 EOF Celery. rdf totalnz= 16 totalz= 17 totallod= 0 lodres= 0.05 0.08 0.07 0.10 0.12 0.05 0.06 0.04 0.04 0.12 16 0.14 0.42 0.18 0.32 0.17 0.05 0.05 EOF Parsely. rdf totalnz= 6 totalz= 94 totallod= 0 lodres= 0.05 0.08 0.18 0.08 0.12 0.11 0.11 EOF Carrot. rdf totalnz= 6 totalz= 0 totallod= 0 lodres= 0.05 0.30 0.28 0.40 0.50 0.39 0.34 EOF Sweetcarn. rdf totalnz= 18 17 totalz= 1584 totallod= 0 lodres= 0.05 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.048 0.04 EOF Acute. AC1 Chronic. CH1 Quantitative Usage Analysis for Linuron Case Number: 0047 PC Code: 35506 Date: October 22, 2001 Analyst: Frank Hernandez Based on available usage information from pesticide surveys for the years of 1992 through 2000, total annual domestic usage of linuron averaged approximately over four hundred thousand pounds of active ingredient (a. i.) for just under four hundred thousand acres treated. Linuron is a herbicide with its largest markets in terms of total pounds of active ingredient allocated to carrots (35%), potatoes (20%), and cotton (17%). Most of the usage is in IL, IN, MD, MI, OH, and WA. Crops with a high percentage of the total U. S. planted acres treated include carrots (75%), celery (24%), 18 asparagus (20%), and potatoes (7%). Crops with less than 1 percent of the crop treated include alfalfa, barley, dry beans, corn, cotton, lettuce, melons, peanuts, rice, rye, sorghum, soybeans, sweet corn, and wheat. Site Acres Grown (000) Acres Treated (000) % of Crop Treated LB AI Applied (000) Average Application Rate Wtd Avg Est Max Wtd Avg Est Max Wtd Avg Est Max lb ai/ A/ yr #appl / yr lb ai/ A/ appl Alfalfa 23,701 1 4 0.00 0.02 1 2 0.7 1.0 0.7 Asparagus 90 18 30 20.39 33.29 18 36 1.0 1.0 1.0 Barley 7,326 0 0 0.00 0.00 0 0 0.5 1.0 0.5 Beans/ Peas, Dry 2,190 3 12 0.14 0.54 2 10 0.8 2.5 0.3 Beans/ Peas, Green 709 1 2 0.10 0.28 0 1 0.4 1.0 0.4 Carrots 104 79 104 75.31 100.00 145 210 1.8 1.0 1.8 Celery 34 8 11 23.67 32.54 4 8 0.5 1.0 0.5 Corn 72,425 7 10 0.01 0.01 15 29 2.1 1.3 1.7 Cotton 12967 88 233 0.68 1.80 72 123 0.8 1.0 0.8 Lettuce 274 2 8 0.61 2.98 1 5 0.6 1.0 0.6 Melons 375 1 2 0.25 0.5051 1 2 1.0 1.0 1.0 Site Acres Grown (000) Acres Treated (000) % of Crop Treated LB AI Applied (000) Average Application Rate Wtd Avg Est Max Wtd Avg Est Max Wtd Avg Est Max lb ai/ A/ yr #appl / yr lb ai/ A/ appl 19 Oats/ Rye 6,184 0 1 0.01 0.01 0 1 0.7 1.0 0.7 Parsley 5 0 0 3.00 6.00 0 2 2.7 3.5 0.8 Parsnips 4 0 0 1.55 2.33 0 0 1.0 1.0 1.0 Peanuts 1,582 0 1 0.03 0.06 1 1 1.1 1.0 1.1 Potatoes 1,433 100 158 6.98 11.03 85 180 0.8 1.0 0.8 Rice 2,992 5 20 0.18 0.66 3 13 0.5 1.1 0.5 Rye 4,364 0 1 0.01 0.02 0 1 0.7 1.0 0.7 Sorghum 11,140 33 107 0.30 0.96 13 52 0.4 1.0 0.4 Soybeans 63,141 25 41 0.04 0.07 53 100 2.1 1.1 2.0 Sweet Corn 732 3 10 0.47 1.37 4 8 1.19 1.6 0.8 Wheat, Spring 21,311 0 2 0.00 0.01 0 1 0.5 1.0 0.5 Wheat, Winter 44,907 7 13 0.01 0.03 3 6 0.4 2.0 0.2 Total 383 577 421 605 COLUMN HEADINGS Wtd Avg = Weighted average­­ the most recent years and more reliable data are weighted more heavily. Est Max = Estimated maximum, which is estimated from available data. Average application rates are calculated from the weighted averages. NOTES ON TABLE DATA Usage data primarily covers 1992 ­ 2000. Calculations of the above numbers may not appear to agree because they are displayed as rounded to the nearest 1000 for acres treated or lb. a. i. (therefore 0 = < 500), and to two decimal percentage points for % of crop treated. Other/ Crop Groups Melons include cantaloupe, watermelon, honeydew, muskmelon, and winter melon. SOURCES: EPA data, USDA, and National Center for Food and Agricultural Policy. 20 cc: JSPunzi (RRB2), Linuron Reg. Std. File, Linuron SF, RF, LAN. RD/ I: RRB2 Chem Review Team (12/ 10/ 2001), Alan Nielsen (12/ 30/ 2001), ChemSac (12/ 12/ 2001), DeSac (12/ 18/ 2001). 7509C: RRB2: John S. Punzi: CM2: Rm 804E: 703­ 305­ 7727: 12/ 20/ 2001.

epa

2024-06-07T20:31:41.902517

regulations

EPA-HQ-OPP-2002-0079-0011

Supporting & Related Material

OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 TXR No: 0050429 30 Jan 2002 Memorandum SUBJECT: LINURON (PC Code: 035506) REVISED Toxicology Disciplinary Chapter for the Reregistration Eligibility Decision Document, (Replaces TXR No. 0050415) FROM: Robert Fricke, Ph. D. Reregistration Branch 2 Health Effects Division (7509C) THRU: Alan Nielsen, Branch Senior Scientist Reregistration Branch 2 Health Effects Division (7509C) TO: Carol Christensen, Risk Assessor Reregistration Branch 2 Health Effects Division (7509C) DP Barcodes: D272367 Submission: S590997 Action Requested: Review toxicology studies submitted by the registrant and prepare the toxicology chapter to support reregistration eligibility decision for linuron Attached is the updated toxicology chapter summarizing the findings of the toxicology studies. LINURON PC Code: 035506 REVISED (Replaces Previous Document TXR No. 0050415) Toxicology Disciplinary Chapter for the Reregistration Eligibility Decision (or Registration Support) Document Date completed: January 30, 2002 Prepared by: Robert F. Fricke, Ph. D Reregistration Branch 2 Health Effects Division Mail Code 7509C Peer reviewed by: Yung Yang, Ph. D. Reregistration Branch 2 Health Effects Division Mail Code 7509C Robert F. Fricke, Toxicologist Yung Yang, Toxicologist TABLE OF CONTENTS 1 HAZARD CHARACTERIZATION ........................................... 5 2 REQUIREMENTS ........................................................ 6 3 DATA GAPS ............................................................ 7 4 HAZARD ASSESSMENT.................................................. 7 4. 1 Acute Toxicity ....................................................... 7 4. 2 Subchronic Toxicity................................................... 8 4.2.1 870.3100 90­ Day Oral Toxicity ­ Rat .............................. 8 4.2.2 870.3150 90­ Day Oral Toxicity ­ Dog .............................. 8 4.2.3 870.3200 21/ 28­ Day Dermal Toxicity ­ Rabbit ....................... 8 4.2.4 870.3250 90­ Day Dermal Toxicity ................................ 8 4.2.5 870.4365 90­ Day Inhalation Toxicity .............................. 9 4. 3 Prenatal Developmental Toxicity ........................................ 9 4.3.1 870.3700a Prenatal Developmental Toxicity Study ­ Rat ................ 9 4.3.2 870.3700b Prenatal Developmental Toxicity Study ­ Rabbit ............ 10 4.4 Reproductive Toxicity ................................................ 11 4.4.1 870.3800 Three­ Generation Reproduction and Fertility Effects ­ Rat .... 11 4.4.2 870.3800 Two­ Generation Reproduction Study in the Rat ............. 13 4. 5 Chronic Toxicity .................................................... 15 4.5.1 870.4300 Combined Chronic Toxicity/ Carcinogenicity Study­ CD( SD) BR Rats ............................................... 15 4.5.2 870.4100b Chronic Toxicity ­ Dog ................................ 17 4.5.3 870.4100b Chronic Toxicity ­ Dog ................................ 18 4.6 Carcinogenicity ..................................................... 19 4.6.1 870.4200b Carcinogenicity Study ­ Crl: CD­ 1 (ICR) BR Mouse ......... 19 4.6.2 870.4300 Carcinogenicity Study­ CD( SD) BR Rats ................... 20 4. 7 Mutagenicity ....................................................... 20 4. 8 Neurotoxicity....................................................... 22 4.8.1 870.6100 Delayed Neurotoxicity Study ­ Hen ....................... 22 4.8.2 870.6200a Acute Neurotoxicity Screening Battery .................... 22 4.8.3 870.6200b Subchronic Neurotoxicity Screening Battery ............... 22 4.8.4 870.6300 Developmental Neurotoxicity Study ...................... 22 4. 9 Metabolism ........................................................ 22 4.9.1 870.7485 Metabolism ­ Rat ..................................... 22 4.9.2 870.7600 Dermal Absorption ­ Rat ............................... 23 4.10 Special Studies ...................................................... 23 4.10.1 Biochemical and Histopathological Effects in Rats ................... 23 4.10.2 Leydig Cell Tumorigenisis in Rat ................................. 25 4.10.3 Special Reproduction Study ­ Cross­ mating ­ Rat ..................... 27 5 TOXICITY ENDPOINT SELECTION ....................................... 28 5.1 See Section 9.2 for Endpoint Selection Table .............................. 28 5. 2 Dermal Absorption ................................................... 28 5.3 Classification of Carcinogenic Potential .................................. 28 5.3.1 Conclusions .................................................. 28 5.3.2 Classification of Carcinogenic Potential ............................ 28 5.3.3 Quantification of Carcinogenic Potential ........................... 28 6 FQPA CONSIDERATIONS................................................ 28 6.1 Special Sensitivity to Infants and Children ................................ 28 6. 2 Recommendation for a Developmental Neurotoxicity Study .................. 29 7 OTHER ISSUES......................................................... 29 8 REFERENCES .......................................................... 29 9 APPENDICES ......................................................... 33 9. 1 Toxicity Profile Summary Tables ....................................... 34 9.1.1 Acute Toxicity Table ........................................... 34 9.1.2 Subchronic, Chronic, and Other Toxicity Table ...................... 34 9.2 Summary of Toxicological Dose and Endpoints for Linuron for Use in Human Risk Assessment......................................................... 41 5 1 HAZARD CHARACTERIZATION The toxicological database for linuron is adequate to assess the potential hazard to humans, including special sensitivity of infants and children. The database will support the reregistration eligibility decision (RED) for the current registered uses. However, the Health Effects Division's Hazard Identification Assessment Review Committee (HIARC) determined that a developmental neurotoxicity study and a 28­ day inhalation study are required to provide better hazard characterization.. Linuron has low acute toxicity by the oral (LD50 = 2600 mg/ kg), dermal (LD50 > 2000 mg/ kg), and inhalation (LC50 > 218 mg/ L) routes of exposure. Linuron is not an eye or skin irritant, and not a skin sensitizer. Chronic toxicity studies in the dog, rat and mouse showed altered hematological findings. Beagle dogs fed linuron at dietary concentration of 625 ppm, resulted in hemolytic anemia and secondary erythropogenic activity evidenced by slightly reduced hemoglobin, hematocrit, and erythrocyte counts accompanied by hemosiderin deposition in liver Kupffer cells and erythroid hyperplasia of bone marrow. In the rat study, linuron, at a dietary dose 125 ppm (5.1 mg/ kg/ day in males and 7.8 mg/ kg/ day in females) caused an increase in the incidence of hemolysis. Microscopic observations revealed increased incidence of hemosiderin in Kupffer cells and increased hemosiderosis in bone marrow, spleen, and/ or mesenteric lymph nodes). Rats also showed decreased body weight gains in both sexes and increased incidences of microscopic changes in the epididymides (perivasculitis/ vasculitis) and renal pelvis (transitional cell hyperplasia and mineralization/ calculi) of males and in the kidneys (calculi in renal tubules) of females. Systemic toxicity observed in mice included increased methemoglobin formation and vacuolation and hemosiderosis of the spleen. Oncogenicity studies in the rat and mouse did not show consistent tumor profiles between sexes and species. In the combined chronic toxicity/ oncogenicity study in rats, common neoplasms, included pituitary adenomas of the pars anterior in both male and female rats and mammary fibroadenomas in female rats. Testicular adenomas were observed in 6, 28 and 54%, respectively for control, 125 and 625 ppm dose groups. Decreased incidences of both these tumor types were noted in the high­ dose female group. In the mouse oncogenicity study, treatment of up to 104 weeks with 1500 ppm resulted in a significant increase in the incidence of hepatocellular adenomas (control, 6%; 1500 ppm, 25%, p < 0.05) in females. Linuron was not mutagenic in bacteria or in cultured mammalian cells. There was also no indication of a clastogenic effect up to toxic doses in vivo. Based on the results of these studies, linuron was classified as an unquantifiable Group C carcinogen (a possible human carcinogen for which there is limited animal evidence) requiring no quantification of human cancer risk.. There is no qualitative/ quantitative evidence of increased susceptibility of rabbit developmental study; developmental effects were seen at a dose higher than that causing maternal toxicity. In the rat developmental study, increases in post­ implantation losses and increases in fetal resorptions/ litter were seen as a dose that caused decreases in maternal body weight and food consumption. The HIARC determined that the developmental effects are not indicative of qualitative evidence of susceptibility, since increases in resorptions were marginal and there was no change in the number of live fetuses to corroborate the increases in post­ implantation losses. 6 There was no quantitative evidence of susceptibility either in the 2­ generation or the 3­ generation reproduction studies. In the 2­ generation study, reduced body weight gains of pups were seen at the same dose that caused decreases in parental body weights. In the 3­ generation study, offspring effects (deceased pup survival and pup body weight) were seen a dose ( 44 mg/ kg/ day) higher than the dose that caused decreases in body weight gain in the parental animals (9 mg/ kg/ day). However, when the reproductive effects were examined, testicular atrophy was seen at the same dose (625 ppm, 45 mg/ kg/ day) in both studies. While the F0 males were not affected, testicular lesions and reduced fertility were seen in the F1 males. This effect in the F1 males is an indication of qualitative evidence of susceptibility. In a metabolism study linuron (single doses at 24 mg/ kg and 400 mg/ kg) was administered by gavage to male and female rats. The biological half­ lives ranged from 21 hr in the low dose males to 56 hr in the high dose females. Total recovery of radioactivity was 96% in males and 97% in females, the majority of the administered 14 C­ linuron was eliminated in the urine (> 80%) and, to a lesser extent, in the feces (~ 15%). Tissue and organ residues were very low (< l%) at both dose levels, and there was no indication of accumulation or retention of linuron or its metabolites. The major metabolites identified in the urine were hydroxy­ norlinuron, desmethoxy linuron and norlinuron, and in feces, hydroxy­ norlinuron, and norlinuron. Neither hydroxy­ 3,4­ dichloroanaline nor 3,4­ dichloroanaline were present in any of the samples. Exposure to linuron appeared to induce mixed­ function oxidative enzymes. There is ample evidence from special studies submitted by the registrant as well as open literature studies which indicate that linuron is an endocrine disruptor. These findings include, in part: (1) competitive androgen receptor antagonist; but not an estrogen receptor antagonist; (2) competitive inhibition of the transcriptional activity of dihydrotestosterone (DHT)­ human androgen receptor (hAR) in vitro, decreased anogenital distance and/ or an increase in the retention of areolae/ nipples in male offspring following in utero exposure to linuron; (3) inhibition of steroidogenic enzymes, and (4) decreased responsiveness of Leydig cells to luteinizing hormone in both immature (22 days) and mature (11 months) male rats treated with linuron, mature rats were less responsive that immature ones; (5) F0 and F1 males had significantly increased levels of estradiol and luteinizing hormone. 2 REQUIREMENTS The requirements (CFR §158.340, revised as of July 1, 1999) for Food and Non­ Food Use for linuron are summarized in Table 1. Use of the new guideline numbers does not imply that the new (1998) guideline protocols were used. 7 Test Technical Required Satisfied 870.1100 Acute Oral Toxicity ......................... 870.1200 Acute Dermal Toxicity ....................... 870.1300 Acute Inhalation Toxicity .................... 870.2400 Primary Eye Irritation ....................... 870.2500 Primary Dermal Irritation ..................... 870.2600 Dermal Sensitization ........................ Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes 870.3100 Oral Subchronic (Rodent) .................... 870.3150 Oral Subchronic (Non­ Rodent) ................ 870.3200 21­ Day Dermal ............................. 870.3250 90­ Day Dermal ............................. 870.3465 28­ Day inhalation 870.3465 90­ Day Inhalation .......................... Yes Yes No No Yes No Yes a Yes a No 870.3700a Developmental Toxicity (Rodent) .............. 870.3700b Developmental Toxicity( Non­ rodent) ........... 870.3800 Reproduction .............................. Yes Yes Yes Yes Yes Yes 870.4100a Chronic Toxicity (Rodent) ..................... 870.4100b Chronic Toxicity (Non­ rodent) ................. 870.4200a Oncogenicity (Rat) ........................... 870.4200b Oncogenicity (Mouse) ........................ 870.4300 Chronic/ Oncogenicity ........................ Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes 870.5100 Mutagenicity— Gene Mutation ­ bacterial ......... 870.5300 Mutagenicity— Gene Mutation ­ mammalian ...... 870.5385 Mutagenicity— Mammalian bone marrow chromosomal aberration test ................... 870.5395 Mutagenicity— in vivo mammalian cytogenetics 870.5550 Mutagenicity— USD in Mammalian cells in vitro ... Yes Yes Yes No Yes Yes Yes Yes Yes 870.6100a Acute Delayed Neurotox. (Hen) ................ 870.6100b 90­ Day Neurotoxicity (Hen) ................... 870.6200a Acute Neurotox. Screening Battery (Rat) ......... 870.6200b 90 Day Neuro. Screening Battery (Rat) ........... 870.6300 Developmental Neurotoxicity .................. No No No No Yes No 870.7485 General Metabolism .......................... 870.7600 Dermal Penetration .......................... Yes No Yes Yes a These data requirements are satisfied by the corresponding chronic studies 3 DATA GAPS 28­ Day inhalation study (OPPTS 870.3465) Developmental neurotoxicity study (OPPTS 870.6300) 4 HAZARD ASSESSMENT 4.1 Acute Toxicity Adequacy of data base for acute toxicity: Linuron has low acute toxicity, with toxicity 8 categories of III for oral (LD50 = 2600 mg/ kg), dermal (LD50 > 2000 mg/ kg) and toxicity category IV for inhalation ( LC50 > 218 mg/ L). Primary eye and skin irritation studies were category III and IV, respectively; no dermal sensitization was observed in guinea pigs. The acute toxicity data for linuron are summarized below in Table 2. Table 2: Acute Toxicity of Linuron, Technical Guideline No. Study Type MRID No. Results Toxicity Category 870.1100 Acute Oral (Rat) 00027625 LD50 = 2600 mg/ kg III 870.1200 Acute Dermal (Rabbit) 00027625 LD50> 2000 mg/ kg III 870.1300 Acute Inhalation (Rat) 00053769 LC50 > 218 mg/ L IV 870.2400 Primary Eye Irritation 42849001 Slight conjunctival redness at 24 hrs; clear at 72 hrs III 870.2500 Primary Skin Irritation 42849002 Not an irritant IV 870.2600 Dermal Sensitization 00146868 Not a sensitizer N/ A 4.2 Subchronic Toxicity Adequacy of data base for subchronic toxicity: No subchronic toxicity studies were available; the respective chronic toxicity studies satisfies the data requirements. A 28­ day inhalation study is required at this time to address the concern for inhalation exposure. 4.2.1 870.3100 90­ Day Oral Toxicity ­ Rat The chronic rat study presented later in section 4.5.1 (870.4100a) satisfies the data requirements for 870.3100. 4.2.2 870.3150 90­ Day Oral Toxicity ­ Dog The chronic dog study presented later in section 4.5.2 (870.4100b) satisfies the data requirements for 870.3150. 4.2.3 870.3200 21/ 28­ Day Dermal Toxicity ­ Rabbit No study available 4.2.4 870.3250 90­ Day Dermal Toxicity No study available 4.2.5 870.4365 90­ Day Inhalation Toxicity 9 No study available. A 28­ day inhalation study has been identified as a data gap by the HIARC. 4.3 Prenatal Developmental Toxicity Adequacy of data base for Prenatal Developmental Toxicity: The data base for prenatal developmental toxicity is considered complete and no additional studies are required at this time. There is no qualitative/ quantitative evidence of increased susceptibility observed in the rat and rabbit developmental toxicity studies 4.3.1 870.3700a Prenatal Developmental Toxicity Study ­ Rat Executive Summary: In a developmental toxicity study (MRID No: 00018167), 27 presumed pregnant Crl: CD rats per group were administered 0, 50, 125, or 625 ppm of linuron (97% a. i.; Lot No. INZ­ 326­ 118) in the diet on gestation days (GD) 6­ 15, inclusive. Average doses to the treated dams were 5.0, 12, and 50 mg/ kg/ day, respectively. The day evidence of mating was found was designated GD 1. Maternal body weights and food consumption were recorded on GD 6, 10, 16, and 21. On GD 21, all surviving dams were sacrificed and all fetuses were weighed and examined for external malformations/ variations. Crown­ rump length was measured on each fetus. Approximately one­ half of the fetuses in each litter were fixed in Bouin's solution for visceral examination and the remaining one­ half were processed for skeletal examination. All animals survived to scheduled termination without the appearance of any treatmentrelated clinical signs of toxicity. Gross necropsy was unremarkable. No treatmentrelated clinical signs of toxicity were observed. Body weight gains and food consumption by the low­ and mid­ dose groups were similar to the controls throughout the study. Body weights of the high­ dose group were significantly (p # 0.05) less than the control group on GD 10, 16, and 21. Food consumption by the high­ dose group was significantly (p # 0.05) less than that of the controls for the intervals of GD 6­ 10 and 10­ 16. The maternal toxicity LOAEL is 625 ppm (50 mg/ kg/ day) based on reduced body weight gain and food consumption. The maternal toxicity NOAEL is 125 ppm (12 mg/ kg/ day). No dose­ or treatment­ related effects were observed on fetal sex ratios, numbers of corpora lutea/ dam, implantations/ dam, live or dead fetuses/ dam, fetal body weights, or crown­ rump length. In the control, low­, mid­, and high­ dose groups post­ implantation loss was 5.8, 3.5, 4.4, and 14.0%, respectively, and the number of resorptions per litter with resorption was 1.6, 1.6, 1.2, and 2.1, respectively. No treatment­ related external or visceral malformations/ variations were noted. In the high­ dose group bipartite thoracic vetebral centra was observed in 7 fetuses from 7 litters and unapposed sternebrae were observed in 3 fetuses from 3 litters. These anomalies were not found in the control group and were considered indicative of developmental delays. 10 The developmental toxicity LOAEL is 625 ppm (50 mg/ kg/ day) based on increases in post­ implantation loss and in litter/ fetal resorptions. The developmental toxicity NOAEL is 125 ppm (12 mg/ kg/ day). This study is classified as Acceptable/ Guideline and does satisfy the guidelines for a developmental toxicity study [OPPTS 870.3700 (83­ 3a)] in rats. Deficiencies included no information on dietary formulation preparation or analyses, the treatment period should have been GD 7­ 16, body weight on GD 0 were not collected, fetal anomalies were not classified as malformations or variations, and fetuses were not individually identified. These deficiencies were considered to be minor. 4.3.2 870.3700b Prenatal Developmental Toxicity Study ­ Rabbit Executive Summary: In a developmental toxicity study (MRID Nos: 00153867 and 40437201), 25 presumed pregnant New Zealand white rabbits per group were administered 0, 5, 25, or 100 mg/ kg/ day of linuron (96.2% a. i.) by gavage on gestation days (GD) 7­ 19, inclusive. Doses were chosen based on the results of a range­ finding study. The vehicle was 0.5% hydroxypropyl­ methylcellulose. On GD 29, all surviving does were sacrificed and the livers weighed. All fetuses were weighed and examined for external and visceral malformations/ variations including free­ hand sectioning of the brain. All fetuses were eviscerated and processed for skeletal examination. No dose­ or treatment­ related clinical signs of toxicity, maternal deaths, or necropsy findings were observed in any group. Absolute body weights and food consumption for the low­ and mid­ dose groups and body weight gain by the low­ dose group were not affected by treatment. Body weight of the high­ dose group was significantly (p # 0.05) less than that of the controls on GD 19. Body weight gains during GD 13­ 16 were slightly less for the middose group (50%, n. s.) and significantly less for the high­ dose group (­ 0.01 g vs 0.08 g for the controls; p # 0.05) as compared with the controls. Similarly, during GD 16­ 20 body weight gains were slightly less for the mid­ dose group and significantly (p # 0.01) less for the high­ dose group (0.00 g for mid­ dose and ­0.12 g for high­ dose vs 0.02 g for the controls) as compared with the controls. Both mid­ and high­ dose groups had significantly (p # 0.05) greater body weight gains as compared with the controls during GD 20­ 24. Food consumption by the high­ dose group was significantly (p # 0.05) less than that of the controls on GD 13­ 16 and 16­ 20. In the high­ dose group, absolute and relative liver weights were increased to 129% (p # 0.01) and 135% (n. s.), respectively of controls. The maternal toxicity LOAEL was established at 25 mg/ kg/ day based on reduced body weight gain. The maternal toxicity NOAEL was established at 5 mg/ kg/ day. The number of fetuses( litters) available for evaluation in the control, low­, mid­, and high­ dose groups was 135( 20), 135( 20), 121( 17), and 79( 13), respectively. 11 Five high­ dose does aborted between days 20­ 25 compared with one control doe on GD 22. The mean number and percentage of resorptions and number of dead fetuses were similar between the treated and control groups. In the high­ dose group, slight (n. s.) decreases in the mean number of live fetuses/ litter (6.1 vs 6.8 for controls) and mean fetal body weight (41.99 g vs 45.8 g for controls) were observed. No treatment­ related external or visceral fetal malformations/ variations were noted. In the control, low­, mid­, and high­ dose groups, skull alterations (irregularly shaped fontanelle, hole in parietals, parietals contain intraparietals, and unossified) were observed in 1( 1), 9( 5), 5( 3), and 19( 6) fetuses( litters), respectively. The litter incidence for the high­ dose group was significantly (p # 0.05) greater than that of the control group. It should be noted that 6 fetuses from 5 low­ dose litters also had a variety of external malformations of the head and body. The developmental toxicity LOAEL was established at 100 mg/ kg/ day based on alterations of the bones of the skull. The developmental toxicity NOAEL was established at 25 mg/ kg/ day. This study is classified as Acceptable/ Guideline and does satisfy the guidelines for a developmental toxicity study [OPPTS 870.3700 (83­ 3b)] in rabbits. 4.4 Reproductive Toxicity Adequacy of data base for Reproductive Toxicity: The data base for reproductive toxicity is considered complete and no additional studies are required at this time. 4.4.1 870.3800 Three­ Generation Reproduction and Fertility Effects ­ Rat Executive Summary: In a three­ generation reproduction study (MRID No.: 00146071 & 00155168), Linuron (94.5% a. i.) was administered to groups of 20 male and 20 female Crl: CD® rats in the diet at concentrations of 0, 25, 125, or 625 ppm. Two litters were produced by the F0 and F1 generations and one litter was produced by the F2 generation. Average premating doses were 0, 2, 9, and 44 mg/ kg/ day, respectively, for F0 males; 0, 2, 10, and 50 mg/ kg/ day, respectively, for F0 females; 0, 2, 9, and 50 mg/ kg/ day, respectively, for F1 males; 0, 2, 11, and 59 mg/ kg/ day, respectively, for F1 females; 0, 2, 9, and 48 mg/ kg/ day, respectively, for F2 males; and 0, 2, 11, and 67 mg/ kg/ day, respectively, for F2 females. F1 and F2 adults were chosen from the F1b and F2b litters, respectively. F0, F1, and F2 male and female parental animals were administered test or control diet for at least 90 days prior to mating, throughout mating, gestation, and lactation, and until necropsy. At weaning 10 F2b pups/ sex/ group were subjected to gross necropsy with microscopic examination of selected tissues. Following the reproductive toxicity evaluations, F1 and F2 adults were maintained on their respective diets, for up to a total of 22 months on study, for hematological evaluations (MRID 00155168). Premature deaths of several adults in each generation were considered incidental to treatment. No treatment­ related clinical signs of toxicity were observed in males or females during premating in any generation. Necropsy findings were not reported for 12 adults. No effects on body weights or body weight gains were seen in the low­ dose groups of any generation; food consumption and food efficiency were not affected by treatment. Body weights of the high­ dose parental animals were significantly (p # 0.05) less than those of the controls beginning on day 7 for the F0 adults and throughout premating for the F1 and F2 adults. Compared with their control levels, body weights for the high­ dose males and females were 83­ 90% and 88­ 93%, respectively, for the F0 adults, 77­ 81% and 74­ 87%, respectively, for the F1 adults, and 72­ 79% and 74­ 81%, respectively, for the F2 adults. Premating weight gains for the high­ dose males and females were significantly (p # 0.05) less than those of the controls in all generations. Body weights of the mid­ dose males were less than those of the controls during each generation, but statistical significance was reached only occasionally. Body weights of the mid­ dose females from all generations were 88­ 94% of the control levels with statistical significance (p # 0.05) attained at most time points. Lower body weights of the mid­ and/ or high­ dose dams after weaning of their litters were considered a continuation of the premating effects on body weights. Hematology results for the F1 rats were inconclusive. No treatment­ related hematological effects were noted in F2 males after continuous feeding for 20 months. However, for F2 females a mild anemia was observed in the mid­ and high­ dose groups at 20 and 22 months. In mid­ and high­ dose females, RBC counts were decreased to 90­ 91% of the controls, hemoglobin was decreased to 89­ 93% of controls, and the percent of reticuloytes was increased to 147­ 213% of the control levels. Although statistical significance was not attained for all endpoints at both sampling intervals, the changes in red cell parameters are considered to be biologically significant. Treatment­ related lesions observed in the liver of high­ dose F2b weanlings are considered systemic toxicity. In the control, low­, mid­, and high­ dose groups, the incidence (average severity) of hepatocellular atrophy was 1/ 10 (2.0), 0/ 10 (0), 2/ 10 (1.5), and 8/ 10 (2.1), respectively, for males and 2/ 10 (3.0), 1/ 10 (3.0), 2/ 10 (2.0), and 10/ 10 (2.5), respectively, for females. The incidence and severity of decreased cytoplasmic vesiculation was the same as that of hepatocellular atrophy for all groups except the high­ dose males in which 10/ 10 were affected with an average severity score of 2.0. The LOAEL for systemic toxicity was established at 125 ppm (average premating dose 9 mg/ kg/ day, males and 10 mg/ kg/ day, females) based on reduced body weights of males and females and anemia in females. The systemic toxicity NOAEL is 25 ppm (premating dose 2 mg/ kg/ day in males and females). Fertility, pup survival, and pup body weights were not affected in the low­ or mid­ dose groups in any generation. In the high­ dose groups, fertility was decreased with each successive litter and generation. The fertility indices for production of the F1a, F1b, F2a, F2b, and F3 litters were 100, 89.5, 63.2, 61.1, and 52.6%, respectively. Mean live litter size at birth and pup viability during lactation days 0­ 4 were significantly (p # 0.05) or slightly reduced for all litters produced by the high­ dose groups. Both of these 13 parameters generally declined with each successive litter and generation. Mean live litter sizes were 6.2­ 9.3 pups for the high­ dose groups compared with 11.7­ 13.3 pups for the control groups. Viability indices for lactation days 0­ 4 were 58.8­ 92.0% for the highdose litters compared with 92.1­ 100% for the control litters. The reproductive toxicity LOAEL was established at 625 ppm (premating dose 44 mg/ kg/ day in males and 48 mg/ kg/ day in females) based on reduced fertility. The reproductive toxicity NOAEL is 125 ppm (average premating dose 9 mg/ kg/ day in males and 10 mg/ kg/ day in females). Body weights of the high­ dose pups from all generations were consistently reduced throughout lactation as compared to those of the controls with statistical significance (p # 0.05) attained at most time points. Body weights of the high­ dose pups from both litters of the F1 and F2 generations were approximately 82­ 94% of the control levels one day after birth and declined to approximately 66­ 80% of the control levels at weaning. In contrast body weights of the high­ dose F3 pups were 84­ 89% of the controls throughout lactation. Differences in absolute and/ or relative organ weights in high­ dose F2b weanlings were considered to be due to lower final body weights. The offspring toxicity LOAEL was established at 625 ppm (premating dose 44 mg/ kg/ day, males and 48 mg/ kg/ day, females) based on decreased pup survival and lower pup body weights. The offspring toxicity NOAEL is 125 ppm (average premating dose 9 mg/ kg/ day in males and 10 mg/ kg/ day in females). This study is classified as Acceptable/ Guideline and satisfies the requirements for a reproduction study (870.3800 [83­ 4]) in rats. 4.4.2 870.3800 Two­ Generation Reproduction Study in the Rat Executive Summary: In a two­ generation reproduction study (MRID No: 41463401), linuron (96.2% a. i.) was administered to groups of 30 male and 30 female Crl: CDBR rats in the diet at concentrations of 0, 12.5, 100, or 625 ppm. One litter was produced by each generation. Average premating doses for the treated F0 groups were 0.74, 5.8, and 36 mg/ kg/ day, respectively, for males and 0.92, 7.3, and 45 mg/ kg/ day, respectively, for females. Average premating doses for the treated F1 groups were 0.95, 7.8, and 54 mg/ kg/ day, respectively, for males and 1.1, 9.2, and 63 mg/ kg/ day, respectively, for females. F0 and F1 parental animals were administered test or control diet for 72 or 75 days, respectively, prior to mating and throughout mating, gestation, and lactation, and until necropsy. No treatment­ related clinical signs of toxicity or mortalities were observed in the adult animals of either generation. Body weights, body weight gains, and food consumption were significantly (p # 0.05) less than those of the controls beginning on day 7 for the high­ dose F0 animals and throughout premating for the mid­ and high­ dose F1 animals. At the end of premating, body weights of the high­ dose F0 males and females were 81% and 86%, respectively, of 14 the controls with overall weight gains 59% and 55%, respectively, of the control values. For the high­ dose F1 males and females final premating body weights were 76% and 75%, respectively, with weight gains 77% and 77%, respectively, of the control levels. Mean daily food consumption levels for the high­ dose groups during the premating interval were 80­ 85% of the control levels. Absolute body weights of the mid­ dose F0 males were occasionally significantly (p # 0.05) less than the controls with premating weight gains and food consumption 88% and 94% (both, p # 0.05), respectively, of the control levels. For the mid­ dose F1 males and females, final premating body weights, body weight gains, and food consumption were 92­ 94% of the control levels. For the mid­ and high­ dose dams of both generations, lower body weights during gestation and lactation were considered a continuation of premating effects. No treatment­ related lesions were noted at necropsy of the F0 males or females. In highdose F1 males, gross lesions of the testes included reduced in size (9/ 30), abnormally large (3/ 30), soft (5/ 30), small epididymides (8/ 30), and unspecified deformities of the epididymides (5/ 30). Microscopically, increased incidences (p # 0.05) of testicular and epididymal lesions were found in high­ dose F1 males as compared with the controls: atrophy (14/ 30), fibrosis (8/ 30), and hyperplasia (7/ 30) in the testes and arteritis (6/ 30), inflammation (5/ 30), and oligospermia (12/ 30) in the epididymides. Only one incidence each of atrophy and oligospermia were observed in control animals. Absolute testes weights of the high­ dose F1 males were significantly (p # 0.05; 80% of control) less than the controls. In high­ dose F1 females, gross findings (n. s.) included cystic ovaries (4/ 30), dilatation (3/ 30), and fluid filled uterine horns (2/ 30), none of which were observed in control animals. In addition, lesions of the eye were noted in high­ dose F1 males and females and were reviewed in MRID 41864701. A significant (p # 0.05) increase was seen in the number of high­ dose F1 males with any type of corneal or conjunctival change (14/ 30 vs 4/ 30 controls). The lesions included corneal degeneration/ basophilia and conjunctival inflammation/ basophilia. Degeneration of the lens was observed in 3/ 30 high­ dose males and 3/ 29 high­ dose females compared with only 1/ 30 control male. However, a clear treatment­ related effect in females was not considered to be definitive. The systemic toxicity LOAEL was established at 100 ppm (average premating doses 5.8­ 9.2 mg/ kg/ day) based on reduced body weight gains in males and females during both generations. The systemic toxicity NOAEL was established at 12.5 ppm (average premating doses 0.74­ 1.1 mg/ kg/ day). No treatment­ related adverse effects were found on the reproductive performance of either generation. For the control, low­, mid­, and high­ dose group, pup viability for lactation days 0­ 4 was 99.4, 98.0, 99.8, and 91.7% (p # 0.05), respectively, for the F1 generation and 96.8, 92.7, 99.5, and 76.2% (p # 0.05), respectively, for the F2 generation. The mean number of pups per litter in the high­ dose F2 group was significantly (p # 0.05) less than the control throughout lactation. The number of litters with pups showing clinical signs was significantly (p # 0.05) increased in both generations. 15 The reproductive toxicity NOAEL was greater than or equal to 625 ppm (average premating doses 36­ 63 mg/ kg/ day) and the reproductive toxicity LOAEL was not established. Body weights of the mid­ and high­ dose F1 male and female pups and of the high­ dose F2 male and female pups were significantly (p # 0.05) less than those of the controls throughout lactation LOAEL for offspring toxicity was established at 100 ppm (average premating doses 5.8­ 9.2 mg/ kg/ day) based on reduced F1a, b and F2a, b pup body weights. The offspring toxicity NOAEL was established at 12.5 ppm (average premating doses 0.74­ 1.1 mg/ kg/ day). This study is classified as Acceptable/ Guideline and satisfies the guideline requirements for a reproductive toxicity study [OPPTS 870.3800 (83­ 4)] in rats. 4.5 Chronic Toxicity Adequacy of data base for chronic toxicity: The data base for chronic toxicity is considered complete and no additional studies are required at this time. 4.5.1 870.4300 Combined Chronic Toxicity/ Carcinogenicity Study­ CD( SD) BR Rats Executive Summary: In a chronic toxicity/ oncogenicity study (MRID 00029680 and MRID 00029679), INZ­ 326 (Linuron; 96.9­ 97.2% a. i.; Lot No. 20427, Batch No. 90, E 6110­ 29B) was administered in the diet to groups of 70 ChR­ CD1 rats/ sex/ dose at concentrations of 0, 50, 125, and 625 ppm (0, 2.1, 5.1, and 27 mg/ kg/ day for males and 0, 3.1, 7.8, and 48 mg/ kg/ day for females) for up to 2 years. Additional groups of 10 rats/ sex/ dose were administered the same diets for 12 months for interim evaluation. All clinical pathology data were reanalyzed (MRID 00 164117) due to inappropriate statistical methods used in the original study report. Linuron had no effect on mortality at any dose, and there were no treatment­ related clinical signs reported. Absolute body weights of the high­ dose male group were decreased to 88­ 91% of controls during weeks 1­ 19, with decreased body weight gain during weeks 0­ 13 and 52­ 104 resulting in body weight gain for the entire study being 89% of controls. Absolute body weights of the high­ dose female group were decreased throughout the study, with the magnitude of the decrease generally increasing throughout the course of the study. The body weight gain of this group for the entire study was 57% of controls. Body weight gain by mid­ dose males was decreased to 64% of controls during the week 52­ 76 interval, with body weight loss during the week 76­ 104 interval being increased to 148% of controls. Body weight gain by the mid­ dose female group was decreased to 75% of controls during the week 52­ 76 interval. There were no toxicologically significant treatment­ related effects on food consumption; however, food efficiency values of high­ dose females were decreased to 74­ 88% of controls during weeks 1­ 4 and to 58% of controls for the entire study period. 16 Histopathology observations consistent with hemolysis were observed at increased incidences in high­ and mid­ dose males and females from the main study and interim sacrifice groups, including hemosiderin in Kupffer cells and increased hemosiderosis in bone marrow, spleen, and/ or mesenteric lymph nodes, and transient decreases in the erythrocyte count, hemoglobin concentration, and hematocrit of the high­ dose female group were noted at 6 and/ or 12 months.. Male rats of the main study group had significantly increased incidences of mineralization/ calculi in the renal pelvis, transitional cell hyperplasia in the renal pelvis, and subacute perivasculitis and/ or vasculitis in the epididyinides at the mid­ and highdose treatment levels. Female rats of the main study group had significantly increased incidences of calculi in renal tubules at the mid­ and high­ dose treatment levels and significantly increased incidences of hepatic sinusoidal ectasia and collecting duct ectasia in the kidney at the high­ dose treatment level. The high­ dose female group also had a non­ statistically significantly increased incidence of transitional cell hyperplasia in the renal pelvis compared to controls. Hepatocellular megalocytosis/ syncytium formation with fibroplasia radiating between hepatic cords, and occasional increased hepatocellular intracytoplasmic basophilia was only observed in the main study high­ dose female group (15/ 68 animals examined at that site) and may have been related to induction of hepatocellular protein synthesis. The significance of this finding is unknown but considered adverse. The lowest­ observed­ adverse­ effect level (LOAEL) for Linuron in ChR­ CD' rats is 125 ppm (5.1 mg/ kg/ day for males and 7.8 mg/ kg/ day for females), based on decreased body weight gains in both sexes, microscopic observations consistent with hemolysis (hemosiderin in Kupffer cells and increased hemosiderosis in bone marrow, spleen, and/ or mesenteric lymph nodes), and increased incidences of microscopic changes in the epididymides (perivasculitis/ vasculitis) and renal pelvis (transitional cell hyperplasia and mineralization/ calculi) of males and kidneys (calculi in renal tubules) of females. The corresponding no­ observed­ adverse­ effect level is 50 ppm (2.1 mg/ kg/ day for males and 3.1 mg/ kg/ day for females). There was a treatment­ related increase in the incidence of testicular interstitial adenomas at the 125 and 625 ppm treatment levels (5.7, 27.5, and 53.6% for control, mid­, and high­ dose males, respectively; p< 0.01). Common neoplasms, included pituitary adenomas of the pars anterior in both male and female rats and mammary fibroadenomas in female rats. Decreased incidences of both these tumor types were noted in the highdose female group. Dosing was considered adequate based on the decreases in body weight and body weight gain of high­ dose females. This chronic toxicity/ oncogenicity study in the rat is Acceptable/ Guideline and does satisfy the guideline requirement for a chronic toxicity/ oncogenicity oral study [OPPTS 870.4300 (§ 83­ 5)] in the rat; however, it must be noted that results from concentration and stability analyses indicate potential variation between nominal and actual diet concentrations which make the exact doses to the animals questionable 4.5.2 870.4100b Chronic Toxicity ­ Dog 17 Executive Summary: In a one­ year chronic toxicity study, linuron (96.2% a. i., Batch No. 16,569) was administered to groups of 4 male and 4 female beagle dogs in the diet at concentrations of 0, 10, 25, 125, or 625 ppm (MRID 40952601). Time­ weighted average doses for the treated groups were 0.29, 0.79, 4.2, and 19 mg/ kg/ day, respectively, for males and 0.30, 0.77, 3.5, and 16 mg/ kg/ day, respectively, for females. No treatment­ related clinical signs of toxicity or mortalities were observed at any dose level. Body weights, body weight gains, and food consumption were not affected by treatment. No treatment­ related ophthalmological lesions or changes in urinalysis parameters were noted and gross necropsy was unremarkable. RBC counts, hemoglobin, and hematocrit were slightly (n. s.) decreased throughout the study in high­ dose males and females as compared with those of the controls. WBC and platelet counts were significantly (p # 0.05) increased in high­ dose females at 3, 6, and 9 months and platelet counts were increased (p # 0.05) in high­ dose males at 3 months. Methemoglobin and sulfhemoglobin levels were significantly (p # 0.05) increased in the 625 ppm males and females at all time points as compared with those of the controls. In addition, for the 125 ppm groups methemoglobin levels were increased (p # 0.05) in males and females at 3 and 6 months while sulfhemoglobin levels were (p # 0.05) increased at 9 months in males and at 3, 9, and 12 months in females. Increased hematopoiesis was observed in the bone marrow from 3/ 4 high­ dose males and 4/ 4 highdose females, compared with none of the control males and only 1/ 4 control females. Cholesterol levels were increased in the high­ dose groups at all time points as compared with control levels with statistical significance (p # 0.05) attained at 3, 6, 9, and 12 months for males and 3 months for females. Absolute liver weights were slightly (n. s.) increased in the 625 ppm males and relative liver weights were significantly (p # 0.05) increased in the 125 and 625 ppm males. No effects on liver weights were noted in females. Increases in the incidence and/ or severity of brown pigment (hemosiderin) deposition in the liver were observed microscopically in high­ dose males and females. The LOAEL for linuron in male and female beagle dogs was established at 125 ppm (4.2 mg/ kg/ day, males and 3.5 mg/ kg/ day, females) based on abnormal hematology findings (increased met­ and sulfhemoglobin levels). The NOAEL was established at 25 ppm (0.79 mg/ kg/ day, males and 0.77 mg/ kg/ day, females). This study is classified as Acceptable/ Guideline and satisfies the guideline requirements for a chronic toxicity study [OPPTS 870.4100 (83­ 1b)] in dogs. 4.5.3 870.4100b Chronic Toxicity ­ Dog Executive Summary: In a 2­ year chronic toxicity study (MRID 00018374), H­ 326 (Lot no. not given, purity not given) was administered in the diet to three dogs/ sex at doses of 18 0, 25, 125, or 625 ppm. Average doses to animals were not measured or calculated. No treatment­ related mortality occurred and no clinical signs of toxicity were reported during the study. One mid­ dose male was sacrificed after 47 weeks due to a neurological disorder not related to treatment. Food and water consumption were not monitored. There were no statistically significant effects on absolute or relative organ weights. Treatment with the test material did induce a slight decrease (8.5%) in the body weight of high­ dose female dogs, as well as a slight decrease in body weight gain. These effects were not observed in male dogs and were not considered biologically or toxicologically relevant in females. At necropsy, no significant changes in gross pathology were observed at any treatment level. Hematocrit, hemoglobin, and erythrocyte counts were slightly but statistically significantly (p # 0.05) reduced in male dogs at 625 ppm after 104 weeks of treatment. Corroborating microscopic pathology data indicated hemosiderin deposition in liver Kupffer cells of 6/ 6 dogs and erythroid hyperplasia in the bone marrow of 3/ 6 dogs (1 male and 2 females) in this group. Under the conditions of this study, the LOAEL for the systemic toxicity of H­ 326 in male and female beagles is 625 ppm based on mild hemolytic anemia and secondary erythropogenic activity evidenced by slightly reduced hemoglobin, hematocrit, and erythrocyte counts accompanied by hemosiderin deposition in liver Kupffer cells and erythroid hyperplasia of bone marrow. The NOAEL is 125 ppm. For a variety of reasons discussed in the study deficiencies, this chronic toxicity study is classified as Unacceptable/ Guideline and does not satisfy the Subdivision F requirements for a chronic oral toxicity study in non­ rodents [OPPTS 870.4100 (§ 83­ 1)]. 4.6 Carcinogenicity Adequacy of data base for Carcinogenicity: The data base for carcinogenicity is considered complete and no additional studies are required at this time. 4.6.1 870.4200b Carcinogenicity Study ­ Crl: CD­ 1 (ICR) BR Mouse Executive Summary: In an oncogenicity study (MRID 00124195), INZ­ 326 (97.0% a. i., Haskell Laboratory identification no. 10720) was administered to groups of 80 male and 80 female Charles River CD®­ 1 mice in the diet at concentrations of 0, 50, 150, or 1500 ppm. The test diets were given for 24 months. The concentrations of 50, 150, and 1500 ppm resulted in mean daily compound intakes for males of 8, 23, and 261 mg/ kg/ day; and for females of 12, 35, and 455 mg/ kg/ day, respectively, calculated from food intake and body weight measurements. No significant treatment­ related effects were seen in clinical signs or survival. Body weights were consistently and significantly lower in males and females at 1500 ppm than in the control groups throughout the study. At 52 weeks, the group mean body weights and weight gains of high­ dose males were 8% and 15% lower than the controls, 19 respectively, and high­ dose females were decreased by 11% and 21%. At 104 weeks, the body weights and weight gains of high­ dose males were 10% and 20% less than the controls, and in high­ dose females were 8% and 14% less than the controls, respectively. The overall food intake for high­ dose males was decreased by about 14% and by 10% for high­ dose females compared to the controls. Food efficiency for the 2­ year study was not significantly affected in treated animals. Increases of 9­ 18% in group mean erythrocyte cell volume and mean cell hemoglobin were seen in males and females after 6 months of treatment at 1500 ppm. Erythrocyte counts were decreased by 9% and 14% in high­ dose males and females, respectively, compared to the controls at 6 months. These hematology values returned to near control levels later in the study. A significant increased incidence of hemosiderin deposits in the spleens of both sexes at 1500 ppm is suggestive of a compensated hemolytic anemia in high­ dose animals. Methemoglobin levels were increased in high­ dose females by 117% compared to the control group, and were increased in high­ dose males by 613% compared to the 50 ppm group (the male control value was not available). Differential white cell counts were within normal parameters for both sexes at all doses. The absolute and relative (to body) liver weights were increased by 20% and 24%, respectively in high­ dose males and by 65% in high dose females compared to the controls. Microscopic evidence of liver toxicity at 1500 ppm included increased incidences of focal hepatocellular cytoplasmic alteration, focal centrilobular peliosis, and centrilobular hepatocytomegaly in both sexes, and increased incidence of hepatocellular cytoplasmic vacuolation in females. The LOAEL for INZ­ 326 in mice is 1500 ppm in the diet for males (261 mg/ kg/ day) and females (455 mg/ kg/ day), based on microscopic liver changes, methemoglobinemia, and decreased body weight and weight gain in both sexes. The NOAEL was 150 ppm for males (23 mg/ kg/ day) and females (35 mg/ kg/ day). Treatment of up to 104 weeks with 1500 ppm INZ­ 326 resulted in a significant increase in the incidence of hepatocellular adenomas (control, 6%; 1500 ppm, 25%, p < 0.05) in female Charles River CD®­ 1 mice under the conditions of this study. Dosing was considered adequate based on the liver changes, methemoglobinemia, and decreased body weights. This oncogenicity study in the mouse is Acceptable (Guideline) and does satisfy the guideline requirement for an oncogenicity study [OPPTS 870.4200 (§ 83­ 2)] in mice. There were a number of deficiencies in this study, but none that would alter the conclusions reached through the available data. Adequacy of the Dose Levels Tested: Dosing was considered adequate based on the decreases in body weights, body weight gains and other systemic effects (microscopic liver changes, methemoglobinemia) in high­ dose males (261 mg/ kg/ day) and females (455 mg/ kg/ day). The chronic/ oncogenicity study presented above in section 4.5 (870.4100a) satisfies the data requirements for 870.4200a. 20 4.6.2 870.4300 Carcinogenicity Study­ CD( SD) BR Rats The executive summary for the chronic/ oncogenicity study is presented above in section 4.5.1 (870.4300) satisfies the data requirements for 870.4300. 4.7 Mutagenicity Adequacy of data base for Mutagenicity: The submitted test battery satisfies the Pre1991 mutagenicity initial testing battery guidelines. No further testing is required at this time. Gene Mutation 870.5100­ Bacterial reverse gene mutation assay MRID 00131738 Acceptable In a reverse gene mutation assay in bacteri, S. typhimurium strains TA98, TA100, TA1535, and TA1537 were exposed to Linuron (95­ 97%, lot number not given) in dimethylsulfoxide at concentrations of 0.5, 0.75, 1.0, 2.5, and 5.0 : g/ plate in the absence of mammalian metabolic activation (S9­ mix) and 1, 5, 10, 50, and 100 : g/ plate in the presence of S­ 9 mix. There was no evidence of induced mutant colonies over background with or without S9 activation. 870.5300 CHO/ HGPRT cell forward gene mutation assay MRID 00137152 Acceptable In a mammalian cell gene mutation assay in vitro, triplicate (in the absence of activation) or duplicate (in the presence of activation) cultures of Chinese hamster ovary (CHO) CHO­ K1­ BH4 cells were exposed to Linuron (Lot No. 1N2­ 326­ 141, 94.5% a. i.) in F12 medium at concentrations of 0.05, 0.25, 0.35, 0.40, 0.45, and 0.50 mM in the absence of mammalian metabolic activation (S9­ mix), and at 0.25, 0.50, 0.75, 0.90, and 1.0 mM in the presence of Charles River S9­ mix. The S9­ fraction was obtained from Aroclor 1254­ induced 8 to 9 week­ old male Charles River CD rats. Linuron was tested up to concentrations limited by cytotoxicity. Cytotoxicity was observed at 0.45 and 0.5 mM under nonactivated conditions and at 0.75 mM and above with 0.5 mg S9 protein/ mL and at 1.0mM and above with 1.0 mg S9 protein/ mL. (Percentage cell survival were not provided in the DER). There was no increase in mutant frequency in cells treated with linuron in either the presence or absence of metabolic activation. The positive (ethyl methane sulfonate (EMS) without S9­ mix and dimethylbenzanthracene with S9­ mix) and solvent (DMSO) controls responded appropriately. No evidence of an increased mutant frequency was observed in the presence or absence of metabolic activation. Cytogenetics 21 870.5385­ In vivo bone marrow chromosomal aberration assay MRID 00137153 Acceptable In a mammalian cell cytogenetics chromosomal aberration assay in bone marrow cells of Sprague­ Dawley rats, 5 rats per sex per harvest time were administered Linuron (94.5%, lot number not given) by single gavage at doses of 0, 100, 300, or 1000 mg/ kg. Bone marrow cells were harvested 6­, 12­, 24­, or 48­ hours after test compound administration and 48 hours after the positive control dose. The vehicle was corn oil (20 mL/ kg) and the positive control was a single 40 mg/ kg dose of cyclophosphamide. One high­ dose rat in the 24­ hour group was found dead and 8 of 10 highdose rats in the 48­ hour group died prior to sacrifice on day 2. Low­ and mid­ dose animals exhibited slight depression, ataxia, and/ or prostration. Treated animals also had decreased body weights compared to controls. There was no significant increase in the frequency of aberrations in bone marrow cells of treated animals compared to controls at any sampling time. Values in treated animals ranged from 0.3­ 0.8% aberrant cells/ group; the positive control group had 19.6% aberrant cells, indicating that this control responded appropriately. There was no change in mitotic index of dosed groups compared to controls. There is no evidence that Linuron induced chromosomal aberrations in bone marrow cells of rats over background levels. Other Genotoxicity 870.5550 ­ Unscheduled DNA synthesis in mammalian cell culture MRID 00132583 Acceptable In an unscheduled DNA synthesis assay, primary rat hepatocyte cultures were exposed to Linuron (94.5% a. i. in dimethylsulfoxide; Lot No. T80311­ 81) in Williams' Medium E (WME) at concentrations of 0.00001, 0.0001, 0.001, 0.01, 0.1, 1.0, 10, and 50.0 mM (trial 1) or 0.01, 0.1, 1.0, 10, and 50.0 mM (trial 2) for 18 hours. There is no evidence that Linuron induced chromosomal aberrations in bone marrow cells of rats over background levels. 4.8 Neurotoxicity Adequacy of data base for Neurotoxicity: No acute or subchronic neurotoxicity studies on Linuron are available. Evaluation of subchronic, chronic and reproduction toxicity, did not reveal any treatment­ related effects on the central or peripheral nervous system of mice, rats, or rabbits. No changes in clinical signs, brain weights, gross necropsy results or histopathological results suggested any part of the nervous system as a target organ. However, the HIARC (Nov 20, 2001) determined that a developmental neurotoxicity study in the rat is required based on the finding that linuron is an endocrine disruptor, increased testicular lesions and decreased fertility. 4.8.1 870.6100 Delayed Neurotoxicity Study ­ Hen This study is not required. 4.8.2 870.6200a Acute Neurotoxicity Screening Battery This study is not required. 22 4.8.3 870.6200b Subchronic Neurotoxicity Screening Battery This study is not required. 4.8.4 870.6300 Developmental Neurotoxicity Study This study is required. 4.9 Metabolism Adequacy of data base for metabolism: The data base for metabolism is considered complete and no additional studies are required at this time. 4.9.1 870.7485 Metabolism ­ Rat Executive Summary: In a metabolism study (00146489, 40142401, 41960001, 42006801), linuron was administered by gavage to male and female rats at single doses of 24 or 400 mg/ kg/ day, Linuron was extensively metabolized by male and female rats at both the low and high­ dose levels. The biological half­ life was affected by sex and dose level and ranged from 21 hours in the low dose males to 56 hours in the high dose females. Total recovery of radioactivity was 96% in males and 97% in females. At 400 mg/ kg, the majority of the administered 14 C­ linuron was eliminated in the urine (81% in males and 72% in females) and, to a lesser extent, in the feces (15% in males and 20% in females). In general, tissue and organ residues were very low (< l%) at both dose levels, and there was no indication of accumulation or retention of linuron or its metabolites. The major metabolites identified in the urine were hydroxy­ norlinuron (59% in males and 64% in females), desmethoxy linuron (11% in males and females) and norlinuron (3% in males and 2% in females), and in feces, hydroxy­ norlinuron,( 28% in males and 32% in females) and norlinuron (28% in males and 23% in females). Neither hydroxy­ 3,4­ dichloroanaline nor 3,4­ dichloroanaline were present in any of the samples. Exposure to linuron appeared to induce mixed­ function oxidative enzymes. This metabolism study in the rat is Acceptable/ Guideline and satisfies the guideline requirement for a metabolism study [OPPTS 870.7485 (§ 85­ 1)] in the rat. 4.9.2 870.7600 Dermal Absorption ­ Rat Executive Summary: In this dermal absorption study (MRID 163837), four grous of 20 rats (one female group and three male groups) were dosed with 14 C (2.35 : Ci/ mg) linuron at 0.12, 1.00, or 7.4 mg/ 2 in 2 (2.82, 23.5, or 17.4 : Ci, respectively). Based on the results of this study, a dermal absorption factor of 16% was observed for an exposure of 8 to 10 hr (2%/ hr). 4.10 Special Studies 4.10.1 Biochemical and Histopathological Effects in Rats 23 Executive Summary: A special study (MRID No: 00164093) was conducted to determine the biochemical and histopathological effects under a variety of conditions of linuron (94.5% a. i.) administration to Crl: CD® BR rats. The rats utilized for various parts of this study were young adult males approximately 22 days old (young), retired breeder males approximately 11 months old (old), and male and female F1b and F2b rats from a multigeneration study (MRID 41463401) maintained on diets of 0, 12.5, 100, or 625 ppm (0, 0.75, 4.1, and 22 mg/ kg/ day, respectively, for males and 0, 1.1, 6.1, and 37 mg/ kg/ day, respectively, for females). Additionally, Leydig cell enzyme analyses were conducted in vitro. The activities of five testicular steroidogenic enzymes were assayed in vitro using horse testicular microsomal preparations in the presence of 0, 0.5, 5, 50, 500, or 5000 : M linuron or linuron metabolites. Enzyme activities measured included aromatase, 17­ 20 desmolase (desmolase), 3­ $ ­hydroxysteriod dehydrogenase/ isomerase (isomerase), 17­ hydroxylase (hydroxylase), and 17­ ketosteriod reductase (reductase). Linuron concentrations of 500 and 5000 : M resulted in significantly decreased aromatase and desmolase and increased reductase activities. At 50 : M the activities of aromatase, desmolase, isomerase, and hydroxylase were decreased by 10­ 20% and reductase was increased by 20% as compared with the controls. Effects of linuron metabolites on enzyme activities were highly variable and generally only seen at 5000 : M. The testosterone metabolic clearance rate was measured in young male rats. Groups of 5 animals were administered 0 or 200 mg/ kg/ day for eight days, castrated, and then infused with testosterone at 3 or 6 : g/ hour. Blood samples were taken every 30 minutes for 180 minutes after the start of infusion. No differences between the treated and control groups were noted at the lower infusion rate. At the higher infusion rate, the mean plateau concentrations (60­ 180 minutes) in the control and treated rats were 769± 344 and 605± 67.4 : g/ dL, respectively, resulting in calculated metabolic clearance rates of 780 and 992 mL/ h, respectively. Due to the large variability between individual animals it was concluded that linuron does not affect testosterone clearance in young, castrated rats. Two trials evaluated the response of Leydig cells to luteinizing hormone (LH). In trial 1, the groups consisted of five young or five old males treated with 0 or 200 mg/ kg/ day for three days, and five 0­ ppm and five 625­ ppm F2b males which were approximately 11 months old. In trial 2, the groups consisted of five young or five old males treated with 0 or 200 mg/ kg/ day for seven days, and five each of the 0, 12.5, 100, and 625 ppm F2b males which were approximately 19 months old. Leydig cells were isolated from the testes and incubated with up to 1000 ng LH/ tube. Results from trial 1 showed no differences in the response between the treated and control young rats. However in old rats, Leydig cells from the treated animals were less responsive than the controls both in maximum response and potency. In contrast, Leydig cells from the chronically treated F2b males were significantly more responsive to LH stimulation as compared with their controls. In trial 2, Leydig cells from treated young and old rats had decreased maximum responses and potency as compared with controls, with old rats more affected than young rats. From the chronically exposed rats, Ledig cells were moderately responsive from the control and low­ dose groups, minimally responsive from the mid­ dose group, but 24 significantly greater in response from the high­ dose group. Taken together, the two trials were reasonably consistent with a preliminary conclusion that there are dose­ and timerelated effects of linuron upon the sensitivity of rat Leydig cells to stimulation by LH. F1b and F2b rats were sacrificed at two years of age for histopathological evaluation of selected tissues. The number of high­ dose males of both generations with small or discolored testes was increased as compared with the controls (stated in text of DER; incidence rates not readable). No other gross observations were noted. Microscopically, mid­ and high­ dose males had increased incidences of interstitial cell adenomas and hyperplasia. Combining data from both generations, adenomas were observed in 1/ 19, 0/ 25, 6/ 25, and 2/ 16 animals and hyperplasia was observed in 2/ 19, 0/ 25, 7/ 25, and 3/ 19 animals from the control, low­, mid­, and high­ dose groups, respectively. The lower incidences in the high­ dose group were probably due to fewer animals available for examination. In females the combined incidence rate for cervical endometrial hyperplasia was 0/ 28, 6/ 30, 9/ 29, and 13/ 29, respectively, and of cervical cystic hyperkeratosis was 0/ 28, 1/ 30, 1/ 29, and 7/ 29, respectively. These lesions in both males and females are consistent with findings in a 2­ year chronic study. In conclusion, the biochemical and histopathological data presented in this report suggest that linuron may affect testosterone metabolism in horse testicular microsomes for a range of concentrations which overlap the dose levels given rats chronically. However, the net effect of these enzyme changes and the relevance to the rat in vivo are uncertain. Evidence in young and old rats exposed repeatedly (3­ 7x) or for 11 or 19 months suggests that Leydig cell incubates are differentially altered in their sensitivity to LH. Microscopic lesions in the testes and cervix have been confirmed in other studies. This study is classified as Acceptable/ Nonguideline as a special mechanistic study in rats. 4.10.2 Leydig Cell Tumorigenisis in Rat Executive Summary: A special mechanism study (MRID No: 41630101) was conducted in male Crl: CD( SD) BR rats. Linuron (96.2% a. i) was administered at 200 mg/ kg/ day by gavage for 14 days to groups of 10 growing (32­ 33 days of age) and adult (93 days of age) rats. Additional groups of 10 rats each were used as negative control, pair­ fed control, and positive control (flutamide, 10 mg/ kg/ day). All rats were observed daily and body weights and food consumption were recorded. At termination, blood was collected for serum hormone analyses and the organs of the reproductive tract were weighed. In addition, blood was collected from the F0 and F1 males and organ weights were recorded from the F0 males from a multigeneration study (MRID 41463401). Premating doses for the multigeneration study were 0.74­ 0.95, 5.8­ 7.8, and 36­ 54 mg/ kg/ day. Finally, linuron and four of its metabolites were evaluated in vitro for their ability to compete for binding to the androgen receptor. No treatment­ related clinical signs of toxicity were observed in the growing rats, the positive controls, or the F0 and F1 rats. Adult rats treated with the test article for 14 days had significantly (p # 0.05) increased incidences of discharge and/ or stains in the perioral, perinasal, and or periocular regions (9/ 10), eye discharge (5/ 10), and weak 25 appearance (9/ 10) as compared with both the negative and pair­ fed control groups. These signs were not observed in the control groups with the exception of one pair­ fed animal with discharge and/ or stains. Final body weights, body weight changes, and food consumption of the 14­ day treated groups, of the pair­ fed control groups, and of the mid­ and high­ dose F0 and F1 groups were significantly (p # 0.05) less than that of their concurrent negative control group values. Final body weight and weight change for the 14­ day adult group were also significantly (p # 0.05) less than those of their pair­ fed control. Body weights and body weight changes were significantly (p # 0.05) reduced only in the adult positive control group as compared with their negative controls (food consumption not measured in positive controls). For growing rats, absolute and relative accessory sex organ unit, prostate, ventral prostate, and seminal vesicle weights were significantly (p # 0.05) reduced as compared with both negative and pair­ fed control groups. Absolute and relative dorsal lateral prostate and levator ani muscle weights and absolute testes weights were significantly (p # 0.05) reduced and relative testes weights were significantly increased (p # 0.05) as compared with the negative controls. Significant (p # 0.05) differences in the pair­ fed control group as compared with the negative control group included decreased absolute accessory sex organ unit, ventral prostate, dorsal lateral prostate, seminal vesicles, and levator ani muscle weights and relative testes and levator ani muscle weights. In the positive control rats, absolute and relative testes weights were not affected, but all other absolute and relative organ weights were significantly (p # 0.05) less than their negative controls. For adult rats, absolute and relative accessory sex organ unit, prostate, and ventral prostate weights were significantly (p # 0.05) reduced as compared with both negative and pair­ fed control groups. Absolute epididymides, seminal vesicle, coagulating gland, and levator ani muscle weights significantly (p # 0.05) reduced as compared with the negative controls. Significant (p # 0.05) differences in the pair­ fed control group as compared with the negative control group included decreased absolute accessory sex organ unit, coagulating gland, and levator ani muscle weights. In the positive control rats, testes weights were not affected, but all other absolute and relative organ weights were significantly (p # 0.05) or slightly (n. s.) less than their negative controls. Significant differences (p # 0.05) in organ weights for the high­ dose F0 males as compared with the controls included decreased absolute epididymides, dorsal lateral prostate, and levator ani muscle weights and increased relative testes, epididymides, and ventral prostate weights. Organ weights were unaffected in the two lower dose groups. Serum testosterone, estradiol, and luteinizing hormone levels in both growing and adult rats were similar to the control levels. However, F0 and F1 males had significantly (p # 0.05) increased levels of estradiol (155 and 115%, respectively) and luteinizing hormone (175 and 168%, respectively). In the positive control groups, testosterone, estradiol, and luteinizing hormone levels were increased (p # 0.05) 304, 123, and 304%, respectively, in growing rats and 915, 100 (n. s.), and 346%, respectively, in adult rats. 26 Linuron and three other compounds [1­ (3,4­ dichlorophenyl)­ 3­ methoxyurea; 3,4­ dichloroanaline; 3,4­ dichlorophenylurea; and 1­( 3,4­ dichlorophenyl)­ 3­ methylurea] appeared to compete with testosterone for binding to the androgen receptor in vitro, although the results were highly variable. IC50 values for linuron and flutamide were approximately 18,000 ± 3,500 and 64,000± 11,000 nM, respectively. 3,4­ dichlorophenylurea did not displace testosterone from the receptor, therefore an IC50 value could not be determined. The remaining metabolites had IC50 ranging from 110,000 to 260,000 nM. In conclusion, linuron may be a weak androgen receptor antagonist based on decreased accessory sex organ weights for growing and adult rats, increased serum luteinizing hormone levels in F0 and F1 rats, and competitive androgen receptor binding in vitro. These data support the hypothesis that rats exposed to linuron could develop interstitial hyperplasia and subsequent adenomas (Leydig cell tumors) via a mechanism of sustained hypersecretion of luteinizing hormone induced by the antiandrogenic potential of linuron. This study is classified as Acceptable/ Nonguideline as a special mechanistic study in rats. 4.10.3 Special Reproduction Study ­ Cross­ mating ­ Rat Executive Summary: A special study (MRID 00159846) was conducted to evaluate the effects of linuron (94.5% a. i.) on the reproduction and lactation performance of crossmated male and female Crl: CD®( SD) BR rats. The rats utilized for this study were the F2 adults from a multigeneration study and the current study was initiated within two weeks after weaning of the last F3a litter. High­ dose (625 ppm) and control animals were cross­ mated to produce F3b and F3c litters; different pairings were made for production of each litter. The data from the original F2 control group from the multigeneration study was used as control data for the current study, but the animals were not remated. The fertility index was calculated in the report as (no. litters delivered/ no. females mated) x 100. The reviewer calculated the following indices: male fertility index = (no. males impregnating females/ no. males exposed to females) x 100; female fertility index = (no. females conceiving/ no. females exposed to males) x 100; and fecundity index = (no. pregnancies/ no. copulations) x 100. During production of both litters, the fertility index and the number of pups/ litter at birth and at weaning were reduced as compared with the control values. The fertility indices for control females crossed with treated males and for treated females crossed with control males were 11.8 and 47.4%, respectively, for the F3b litters and 41.2 and 42.1%, respectively, for the F3c litters as compared with 89.5% for the controls. The number of pups/ litter at birth was 4.0­ 9.2 for the cross­ mated groups and 13.1 for the controls. At weaning the number of pups/ litter was 4.0­ 4.3 for the F3b litters and the F3c litters from treated females crossed with control males compared with 8.1 pups/ litter for both the control group and the F3c litters from control females crossed with treated males. In production of both litters, male and female fertility indices for the groups in which the males were treated were reduced (47­ 71% for males and 47­ 60% for females) compared 27 with those for groups in which the females were treated (90­ 86% for males and 85­ 85% for females). The fecundity index was reduced only for treated males crossed with control females during production of the F3b litters (25%) as compared with the other groups (56.2­ 63.6%). Pup viability was decreased in litters from treated dams mated with control males as compared with litters from control dams mated with treated males. Pup viability for days 0­ 4 was 77.5% in litters from treated dams and 98.5% in litters from control dams while viability for days 1­ 4 was 88.6% and 98.7%, respectively. Litter survival was 75% from treated dams compared with 100% from control dams. Mean pup body weights from treated dams were also slightly or significantly (p # 0.05) less than those from the control dams throughout lactation. The cross­ mating results suggest that linuron may cause paternally­ mediated effects based on decreased fertility and fecundity as well as maternally­ mediated effects based on decreased pup viability and litter survival. This study is classified as Acceptable/ Nonguideline as a special cross­ mating study in rats. 5 TOXICITY ENDPOINT SELECTION 5.1 See Section 9.2 for Endpoint Selection Table 5.2 Dermal Absorption For Executive Summary see section 4.9.2 The dermal absorption factor = 16% 5.3 Classification of Carcinogenic Potential 5.3.1 Conclusions Linuron was placed in special review for carcinogenic effects in 1982. Linuron was later classified as a group C carcinogen on the basis of a dose­ related increase in interstitial cell hyperplasia and adenomas in a two­ year rat feeding study (00029680) and hepatocellular tumors that appeared in low­ dose male and high­ dose female mice in a two­ year feeding study (00124195). Subsequent review by the HED peer review committee and the Science Advisory Panel again classified linuron as a Group C carcinogen requiring no quantification of human cancer risk [Federal Register 53( 159): 31262]. 5.3.2 Classification of Carcinogenic Potential Group C carcinogen 5.3.3 Quantification of Carcinogenic Potential 28 Not quantification of human cancer risk is required 6 FQPA CONSIDERATIONS 6.1 Special Sensitivity to Infants and Children There is no qualitative/ quantitative evidence of increased susceptibility seen in the rabbit developmental study; developmental effects were seen at a dose higher than that causing maternal toxicity. In the rat developmental study, increases in post­ implantation losses and increases in fetal resorptions/ litter were seen as a dose that caused decreases in maternal body weight and food consumption. The HIARC determined that the developmental effects are not indicative of qualitative evidence of susceptibility, since increases in resorptions were marginal and there was no change in the number of live fetuses to corroborate the increases in postimplantation losses. There was no quantitative evidence of susceptibility either in the 2­ generation or the 3­ generation reproduction studies. In the 2­ generation study, reduced body weight gains of pups were seen at the same dose that caused decreases in parental body weights. In the 3­ generation study, offspring effects (deceased pup survival and pup body weight) were seen a dose ( 44 mg/ kg/ day) higher than the dose that caused decreases in body weight gain in the parental animals (9 mg/ kg/ day). However, when the reproductive effects were examined, testicular atrophy was seen at the same dose (625 ppm, 45 mg/ kg/ day) in both studies. In both studies, while the F0 males were not affected, testicular lesions and reduced fertility were seen in the F1 males. This effect in the F1 males is an indication of qualitative evidence of susceptibility. 6.2 Recommendation for a Developmental Neurotoxicity Study Although there was no evidence for increased susceptibility in rats, based on the findings that linuron is an endocrine disruptor, increased testicular lesions and decreased fertility, the HIARC concluded that a development neurotoxicity study in the rat is required. 7 OTHER ISSUES None 8 REFERENCES 00018167 E. I. du Pont de Nemours & Company (1978) Teratogenicity Study of 3­ (3,4­ Dichlorophenyl)­ 1­ methoxy­ 1­ methylurea in Rats: Haskell Laboratory Report No. 33­ 79. (Unpublished study received Sep13, 1979 under 352­ 270; CDL: 240982­ B) 00018374 Hodge, H. C. and W. L. Downs (1963). Chronic feeding studies of Linuron (Herbicide 326) in dogs. Department of Pharmacology, University of Rochester 29 School of Medicine and Dentistry, Rochester, NY. Laboratory Study ID not given. February 1, l963. 00027625 Consultox Laboratories, Limited (1974) Linuron: Acute Oral and Dermal Toxicity Evaluation: CL74 : 46 : 996G. (Unpublished study received Dec 19, 1977 under 33660­ 11; submitted by Industrial Prodotti Chimici s. p. a., Novate Milanese, Italy; CDL: 232505­ A) 00029679 Everett, R. (1980) Two­ year feeding study­ ChR­ CD rats. Haskell Laboratory for Toxicology and Industrial Medicine, Central Research and Development Department, E. I. du Pont de Nemours and Company, Newark, DE 19711. Pathology Report No. 1­ 80, February 4, 1980, Unpublished. 00029680 Kaplan, A., L., et. al. (1980) Long­ term feeding study in rats with 3­( 3,4­ dichlorophenyl)­ l­ methoxy­ l­ methylurea (Lorox', linuron: INZ­ 326). Haskell Laboratory for Toxicology and Industrial Medicine, Central Research and Development Department, E. I. du Pont de Nemours and Company, Newark, DE 19711. Laboratory report number, 100­ 80, full study date not provided. Unpublished. 00053769 Kapp, R. W. (1975) Final Report: Acute Inhalation Toxicity Study in Rats: Project No. M915­ 103. (Unpublished study received Dec 19, 1977 under 33660­ 11; prepared by Hazleton Laboratories America, Inc., submitted by Industria Prodotti Chimici, s. p. a., Novate Milanese, Italy; CDL: 232505­ E) 00124195 Wood, C.; et al. (1982) Long­ term Feeding Study with ... Lorox, Linuron, Inz­ 326 in Mice: Haskell Laboratory Report No. 758­ 82. Final rept. (Unpublished study received Jan 13, 1983 under 352­ 326; submitted by E. I. du Pont de Nemours & Co., Inc., Wilmington, DE; CDL: 249255­ A; 249256) 00131738 Russell, J. (1983) Mutagenicity Evaluation in Salmonella typhimurium: Haskell Laboratory Report No. 106­ 83; MR No. 4581­ 067. (Unpublished study received Oct 26, 1983 under 352­ 326; submitted by E. I. du Pont de Nemours & Co., Inc., Wilmington, DE; CDL: 251571­ A) 00132583 Chromey, N.; Horst, A.; McCooey, K. (1983) Unscheduled DNA Synthesis/ Rat Hepatocytes in vitro: Haskell Laboratory Report No. 190­ 83; MR No. 4581­ 067. (Unpublished study received Oct 26, 1983 under 352­ 326; submitted by E. I. du Pont de Nemours & Co., Inc., Wilmington, DE; CDL: 251571­ B) 00137152 McCooey, K. (1983) CHO/ HGPRT Assay for Gene Mutation: [Linuron]: Haskell Laboratory Report No. 540­ 83; MR No. 4581­ 067. (Unpublished study received Jan 12, 1984 under 352­ 326; submitted by E. I. du Pont de Nemours & Co., Inc., Wilmington, DE; CDL: 252172­ A) 00137153 Farrow, M., et al. (1983) In vivo Bone Marrow Chromosome Study in Rats: [H# 14,703]: HLA Project Number 201­ 584. Final rept. (Unpublished study received 30 Jan 12, 1984 under 352­ 326; prepared by Hazleton Laboratories America, Inc., submitted by E. I. du Pont de Nemours & Co., Inc., Wilmington, DE; CDL: 252172­ B) 00146071 Pastoor, T. (1984) Multigeneration Reproduction Study in Rats with 3­( 3,4­ Dichlorophenyl)­ 1­ methoxy­ 1­ methylurea (Lorox, Linuron, INZ­ 326): Haskell Laboratory Report No. 436­ 84. Unpublished study prepared by E. I. du Pont de Nemours & Co., Inc. 347 p. 00146489 Carter, L. (1985) Metabolism of Phenyl­[ Carbon 14 (UL)] Linuron by Male and Female Rats: Document No. AMR­ 250­ 84. Unpublished study prepared by E. I. du Pont de Nemours & C0., Inc. 110 p. 00146868 Schulz, M. (1985) Guinea Pig Maxinization Test Using Linuron Technical: Intox Sample No. 584: Project NO. GRF­ AT­ 008. Unpublished study prepared by Intox Laboratories. 19 p. 00153867 Hoberman, A. (1985) Developmental Toxicity Study of INZ­ 326 Administered Via Gavage to New Zealand White Rabbits: Final Report: Protocol 104­ 009. Unpublished study prepared by Argus Research Laboratories, Inc. 214 p. 00155168 Holt, D.; Carakostas, M. (1985) Hematologic Values in Rats Fed for 20, 22 or 26 Months with 0,25,125 or 625 ppm INZ­ 326: Haskell Lab. Rep. No. 760­ 85; Clinical Pathology Rep. No. 21­ 85. Unpublished study prepared by Haskell Laboratory. 68 p. 00159846 Pastoor, T. (1985) Cross­ mating Study in Rats with INZ­ 326: Report No. 413­ 85: MR No. 4580­ 001. Unpublished study prepared by E. I. du Pont de Nemours and Co. 70 p. 00163837 Anderson, J. (1984) Dermal Absorption of Carbon 14 Linuron in the Lorox L Formulation by the Rat: Document No. AMR­ 259­ 84. Unpublished study prepared by E. I. du Pont de Nemours & Co., Inc. 29 p. 00164093 Pastoor, T. (1986) Biomedical and Pathological Effects of Linuron on Selected Tissues of Male and Female Rats: Report No. 643­ 86: MR No. 4580­ 001. Unpublished study prepared by Haskell Laboratory for Toxicology and Industrial Medicine in cooperation with E. I. du Pont de Nemours and Co. 468 p. 00164117 Carakostas, M. (1986) Evaluation of clinical laboratory data from two­ year rat study with INZ­ 326. Central Research and Development Department, Haskell Laboratory for Toxicology and Industrial Medicine. Re­ evaluation of data from Haskell Laboratory Report number 100­ 80, with no new laboratory or registrant report or study number provided, August 13, 1986, Unpublished. 40142401 Cater, L. (1985) Metabolism of Phenyl­ Carbon 14( UL) Linuron by Male and Female Rats: ?Supplement to F : Report No. AMR­ 250­ 84. Unpublished study 31 prepared by E. I. du Pont de Nemours & Co. 62 p. 40437201 Christian, M. and Hoberman, A. (1985) Supplement to: Developmental Toxicity Study of INZ­ 326 Administered via Gavage to New Zealand White Rabbits: Laboratory Project ID: MR 7560­ 001; HLO 609­ 85. Unpublished study prepared by Argus Research Laboratories, Inc. 76 p. 40952601 Malley, L. (1988) Chronic Toxicity Study with IN Z326­ 118: One­ Year Feeding Study in Dogs: Report No. 181­ 88; Medical Research Project No. 8031­ 001. Unpublished study prepared by E. I. du Pont de Nemours and Co., Inc. 660 p 41463401 Mullin, L. (1990) Reproductive and Fertility Effects with INZ326­ 118 (Linuron) Multigeneration Reproduction Study in Rats: Medical Research Project 511­ 001: Haskell Laboratory Report 20­ 90. Unpublished study prepared by E. I. du Pont de Nemours and Co., Haskell Laboratory for Toxicology and Industrial Medicine. 1104 p. 41630101 Cook, J. (1990) Investigation of a Mechanism for Leydig Cell Tumorigenesis by Linuron in Rats: Lab Project Number: 494/ 90. Unpublished study prepared by E. I. du Pont de Nemours & Company Inc. 173 p. 41864701 Stula, E. (1990) Reproductive and Fertility Effects with IN Z326­ 118 MultiGeneration Reproduction Study in Rats: Revised Supplemental: Lab Project Number: 8511­ 001: 20­ 90. Unpublished study prepared by E. I. du Pont de Nemours and Co. 41960001 Hundley, S. (1991) Metabolism of [Phenyl­ Carbon­ 14( U)] Linuron by the Laboratory Rat: Lab Project Number: HLR 351­ 91: 1448­ 89. Unpublished study prepared by E. I. du Pont de Nemours and Co. 7 p. 42006801 Brown, A. (1991) Supplement No. 1 to: Metabolism of [Phenyl­ 14­ Carbon (U)] Linuron by the Laboratory Rat: Lab Project Number: HLR 351­ 91: 1448­ 89. Unpublished study prepared by E. I. du Pont de Nemours and Co., Inc. 67 p. 42849001 Shibata, R. (1992) A Primary Eye Irritation Study of Linuron Technical in the Rabbit: Final Report: Lab Project Number: BOZO/ B­ 2177: B­ 2177. Unpublished study prepared by Bozo Research Center Inc. 24 p. 42849002 Allen, D. (1993) Linuron Technical: Primary Skin Irritation Test in the Rabbit: Lab Project Number: 498/ 21. Unpublished study prepared by Safepharm Labs, Ltd. 13 p. Fed Reg Linuron; Preliminary determination to Conclude the Special Review Notice 53( 159): 31262 (August 17, 1988) U. S. EPA LINURON ­ Report of the Hazard identification Assessment Review Committee HED Doc No: 0050286 (November 20, 2001) 32 U. S. EPA LINURON: Report of the FQPA Safety Factor Committee, TXR NO. 0050322 (December 6, 2001) 33 9 APPENDICES Tables for Use in Risk Assessment 34 9.1 Toxicity Profile Summary Tables 9.1.1 Acute Toxicity Table ­ See Section 4.1 9.1.2 Subchronic, Chronic, and Other Toxicity Table Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 870.3100 90­ Day oral toxicity­ rat Requirement fulfilled by Chronic rat study870.4100a N/ A 870.3150 90­ Day oral toxicity­ dog Requirement fulfilled by Chronic dog study870.4100b N/ A 870.3200 21/ 28­ Day dermal toxicity­ rabbit No study available N/ A 870.3250 90­ Day dermal toxicity No study available N/ A 870.3465 90­ Day inhalation toxicity No study available N/ A 870.4100 [83­ 1( b)] 1­ Year Feeding Study ­ Dog 40952601 (1988) Acceptable/ Guideline 0, 10, 25, 125, 625 ppm % % : 0, 0.29, 0.79, 4.2, 19 mg/ kg/ day & & : 0, 0.30, 0.77, 3.5, 16 mg/ kg/ day NOAEL= 0.77 mg/ kg/ day LOAEL = 3.5 mg/ kg/ day, based on hematological effects in males and females (increased methemoglobin and sulfhemoglobin levels) Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 35 870.4100 [83­ 1( b)] 2­ Year Feeding Study ­ Dog 00018374 (1963) Unacceptable/ Guideline 0, 25, 125, 625 ppm 0, 0.6, 3.1, 16 mg/ kg/ day (based on standard conversion factor of 0.025 .mg/ kg/ day per ppm) NOAEL= 3.1 mg/ kg/ day LOAEL = 16 mg/ kg/ day, based on mild hemolytic anemia, slightly deceased hemoglobin, hematocrit, and RBC counts 870.4200 [83­ 2 (b)] Oncogenicity Study ­ Mouse 0124195 (1981) Acceptable/ Guideline 0, 50, 150, and 1500 ppm 0, 8, 23, and 261 mg/ kg/ day in males and 0, 12, 35, and 455 mg/ kg/ day in females NOAEL= 23 mg/ kg/ day LOAEL = 261 mg/ kg/ day, based on microscopic liver changes, methemoglobinemia, and deceased body weight gain throughout the study Histopathology: hepatocytomegaly, hepatocellular cytoplasmic alterations, vacuolation, and necrosis in liver, slightly increased incidence of hemosiderosis in spleens of both sexes; significant increase in hepatocellular adenomas in females 870.4300 [83­ 5( a)] Combined Chronic Toxicity/ Carcinogenicity Study ­ Rat 0029680, 00029679 (1980) 00167411 (1986) Acceptable/ Guideline 0, 50, 125, 625 ppm 0, 2.1, 5.1, 27 mg/ kg/ day in males and 0, 3.1, 7.8, 48 mg/ kg/ day in females NOAEL= 2.1 mg/ kg/ day LOAEL = 5.1 mg/ kg/ day, based on hematological effects, decreased body weight gains in both sexes, microscopic observations consistent with hemolysis (hemosiderin in Kupffer cells and increased hemosiderosis in bone marrow, spleen, and/ or mesenteric lymph nodes) Histopathology: Significant (p = 0.004) increase (27%, 5.7% control) in incidence of benign interstitial cell adenomas in testes. Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 36 870.3700 [83­ 3( a)] Developmental Toxicity Study ­ Rat 00018167 (1979) Acceptable/ Guideline 0, 50, 125, 625 ppm & & : 0, 5.0, 12, 50 mg/ kg/ day Maternal Systemic NOAEL: 12 mg/ kg/ day LOAEL = 50 mg/ kg/ day, based on decreased maternal body weight (9%) and food consumption (7­ 8%). Developmental NOAEL: 12 mg/ kg/ day LOAEL = 50 mg/ kg/ day, based on increased post­ implantation loss and litters with early resorptions. 870.3700 [83­ 3( b)] Developmental Toxicity ­ Rabbit 00153867 (1985), 40437201( 1985) Acceptable/ Guideline 0, 5, 25, 100 mg/ kg/ day Maternal Systemic NOAEL= 5 mg/ kg/ day LOAEL = 25 mg/ kg/ day, based on decreased maternal body weight gain. Developmental NOAEL = 25 mg/ kg/ day LOAEL = 100 mg/ kg/ day, based on alterations of the bones and skull (irregularly shaped fontanelle, hole in parietals, parietals contain intraparietals, and unossified). 870.3800 [83­ 4] 3­ Generation Reproduction ­ Rat 00146071 (1984) 00155168 (1985) Acceptable/ Guideline 0, 25, 125, 625 ppm % % : 0, 2, 10­ 11, 48­ 50 mg/ kg/ day & & : 0, 2, 9, 44­ 50 mg/ kg/ day Systemic NOAEL= 2 mg/ kg/ day LOAEL = 9 mg/ kg/ day, based on decreased body weight gains in males and females and anemia in females. Reproductive NOAEL = 10 mg/ kg/ day LOAEL = 44 mg/ kg/ day based on reduced fertility, decreased pup survival and lower pup body weights. Offspring NOAEL = 9 mg/ kg/ day LOAEL = 44 mg/ kg/ day, based on decreased pup survival, and lower pup body weights. The offspring toxicity NOAEL is Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 37 870.3800 [83­ 4] 2­ Generation Reproduction ­ Rat 41463401 (1990) 41864701 (1991) Acceptable/ Guideline 0, 12.5, 100, 625 ppm % % : 0, 0.74, 5.8, 36 mg/ kg/ day & & : 0, 0.92, 7.3, 45 mg/ kg/ day, Systemic NOAEL= 0.74 mg/ kg/ day LOAEL = 5.8 mg/ kg/ day, based on decreased body weight gains in males and females in both generations Reproductive NOAEL = 36 mg/ kg/ day LOAEL = not established Offspring NOAEL= 0.74 mg/ kg/ day LOAEL = 5.8 mg/ kg/ day, based on decreased pup survival and lower pup body weights of F1a, b and F2a, b litters 870.7600 (85­ 2) Dermal Penetration Rat 00163837 (1984) Acceptable/ Guideline 14 C (2.35 : Ci/ mg) 0.12, 1.00, or 7.4 mg/ 2 in2 2.82, 23.5, or 17.4 : Ci Dermal absorption factor = 16% over 8 to 10 hours. Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 38 870.7485 (85­ 1) Metabolism Study Rat 00146489 (1985), 40142401 (1985) 41960001 (1991 42006801 (1991) Linuron (single doses at 24 mg/ kg and 400 mg/ kg) was administered by gavage to male and female rats. The biological half­ lives ranged from 21 hr in the low dose males to 56 hr in the high dose females. Total recovery of radioactivity was 96% in males and 97% in females, the majority of the administered Clinuron was eliminated in the urine (> 80%) and, to a lesser extent, in the feces (~ 15%). Tissue and organ residues were very low (< l%) at both dose levels, and there was no indication of accumulation or retention of linuron or its metabolites. The major metabolites identified in the urine were hydroxy­ norlinuron, desmethoxy linuron and norlinuron, and in feces, hydroxy­ norlinuron, and norlinuron. Neither hydroxy­ 3,4­ dichloroanaline nor 3,4­ dichloroanaline were present in any of the samples. Exposure to linuron appeared to induce mixed­ function oxidative enzymes. Special Study Leydig cell tumorigenesis in rats 41630101 (1990) Acceptable/ Nonguideline 0 or 200 mg/ kg/ day for 14 days to 32 to 33 and 93 day old rats No treatment­ related clinical signs of toxicity were observed. Body weight and body weight change were significantly less than controls and decreased accessory sex organ weights for growing and adult rats. Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 39 0, 0.74, 5.8, 36 mg/ kg/ day in males and 0, 0.92, 7.3, 45 mg/ kg/ day in females F0 and F1 animals from 2­ generation reproduction study (41463401), Selected animals from the 2­ generation reproduction study were used to evaluate changes in serum hormone levels, accessory sex organ weights. Increased serum luteinizing hormone and estradiol levels were observed in F0 and F1 males. High­ dose F0 males had decreased absolute epididymides, dorsal lateral prostate, and levator ani muscle weights and increased relative testes, epididymides, and ventral prostate weights. Organ weights were unaffected in the two lower dose groups. These data support the hypothesis that rats exposed to linuron could develop interstitial hyperplasia and subsequent adenomas (Leydig cell tumors) via a mechanism of sustained hypersecretion of luteinizing hormone induced by the antiandrogenic potential of linuron. Special Study Cross Mating 00159846 (1985) Acceptable/ Nonguideline 0, 625 ppm % % : 0, 48 mg/ kg/ day & & : 0, 44 mg/ kg/ day The cross­ mating results suggest that linuron may cause paternally­ mediated effects based on decreased fertility and fecundity as well as maternally­ mediated effects based on decreased pup viability and litter survival. Special Study Aged male rats 45506501 (1986) Acceptable/ Nonguideline 0, 625 ppm 0, 22 mg/ kg/ day Linuron induced hyperplasia and adenomas of the testes in aged rats. In addition, life­ time feeding was not necessary to induce oncogenic responses in this tissue. Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 40 Special Study Biochemical and Histopathological effects 164093 (1986) Acceptable/ Nonguideline 0, 12.5, 100, 625 ppm % % : 0, 0.75, 4.1, 22 mg/ kg/ day & & : 0, 1.1, 6.1, 37 mg/ kg/ day The biochemical and histopathological data presented in this report suggest that linuron may affect testosterone metabolism in horse testicular microsomes for a range of concentrations which overlap the dose levels given rats chronically. However, the net effect of these enzyme changes and the relevance to the rat in vivo are uncertain. Evidence in young and old rats exposed repeatedly (3­ 7x) or for 11 or 19 months suggests that Leydig cell incubates are differentially altered in their sensitivity to LH. Microscopic lesions in the testes and cervix have been confirmed in other studies. 41 9.2 Summary of Toxicological Dose and Endpoints for Linuron for Use in Human Risk Assessment 42 Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF and Endpoint for Risk Assessment Study and Toxicological Effects Acute Dietary females 13­ 50 years of age NOAEL = 12 UF = 100 Acute RfD = 0.12 mg/ kg/ day FQPA SF = 3 aPAD = acute RfD FQPA SF = 0.04 mg/ kg/ day Prenatal Oral Developmental / Rat LOAEL = 50 mg/ kg/ day based on increased post­ implantation loss and fetal/ litter resorptions. Acute Dietary general population including infants and children N/ A N/ A No appropriate effects attributed to a single exposure was identified. Chronic Dietary all populations NOAEL= 0.77 mg/ kg/ day UF = 100 Chronic RfD = 0.0077 mg/ kg/ day FQPA SF = 10 cPAD = chr RfD FQPA SF = 0.00077 mg/ kg/ day Chronic Feeding Study ­ Dog LOAEL = 4.2 mg/ kg/ day in males and 3.5 mg/ kg/ day in females based on increased met­ and sulfhemoglobin levels. Short­ Term Oral (1­ 7 days) (Residential) NOAEL= 5.8 mg/ kg/ day LOC for MOE = 1000 (Residential, includes the FQPA SF) 2­ Generation Reproduction Study/ Rat LOAEL = 36 mg/ kg/ day based on statistically and biologically significant decrease in premating body weights in F0 and F1 animals IntermediateTerm Oral (1 week ­ several months) (Residential) NOAEL= 0.77 mg/ kg/ day LOC for MOE = 1000 (Residential, includes the FQPA SF) Chronic Feeding Study ­ Dog LOAEL = 4.2 mg/ kg/ day in males and 3.5 mg/ kg/ day in females based on increased met­ and sulfhemoglobin levels. Short­ Term Dermal (1­ 30 days) (Occupational/ Residential) Oral NOAEL= 5.8 mg/ kg/ day dermal absorption rate = 16% LOC for MOE = 100 (Occupational) LOC for MOE = 1000 (Residential, includes the FQPA SF) 2­ Generation Reproduction Study/ Rat LOAEL = 36 mg/ kg/ day based on statistically and biologically significant decrease in premating body weights in F0 and F1 animals Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF and Endpoint for Risk Assessment Study and Toxicological Effects 43 IntermediateTerm Dermal (1 ­ 6 months) (Occupational/ Residential) Oral NOAEL= 0.77 mg/ kg/ day dermal absorption rate = 16% LOC for MOE = 100 (Occupational) LOC for MOE = 1000 (Residential, includes the FQPA SF) Chronic Feeding Study ­ Dog LOAEL = 4.2 mg/ kg/ day in males and 3.5 mg/ kg/ day in females based on increased met­ and sulfhemoglobin levels after 3 and 6 months of treatment Long­ Term Dermal (Longer than 6 months) (Occupational/ Residential) Oral NOAEL= 0.77 mg/ kg/ day dermal absorption rate = 16% LOC for MOE = 100 (Occupational) LOC for MOE = 1000 (Residential, includes the FQPA SF) Chronic Feeding Study ­ Dog LOAEL = 4.2 mg/ kg/ day in males and 3.5 mg/ kg/ day in females based on increased met­ and sulfhemoglobin levels. Short­ Term Inhalation (1­ 30 days) (Occupational/ Residential) Oral NOAEL= 5.8 mg/ kg/ day (inhalation absorption rate = 100% LOC for MOE = 1000 (Residential, includes the FQPA SF) 2­ Generation Reproduction Study/ Rat LOAEL = 36 mg/ kg/ day based on statistically and biologically significant decrease in premating body weights in F0 and F1 animals IntermediateTerm Inhalation (1 to 6 months) (Occupational/ Residential) Oral NOAEL= 0.77 mg/ kg/ day (inhalation absorption rate = 100% LOC for MOE =1000 (Residential, includes the FQPA SF) Chronic Feeding Study ­ Dog LOAEL = 4.2 mg/ kg/ day in males and 3.5 mg/ kg/ day in females based on increased met­ and sulfhemoglobin levels. Long­ Term Inhalation (Longer than 6 months) (Occupational/ Residential) Oral NOAEL= 0.77 mg/ kg/ day inhalation absorption rate = 100% LOC for MOE = 100 (Occupational) LOC for MOE = 1000 (Residential, includes the FQPA SF) Chronic Feeding Study ­ Dog LOAEL = 4.2 mg/ kg/ day in males and 3.5 mg/ kg/ day in females based on increased met­ and sulfhemoglobin levels. Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF and Endpoint for Risk Assessment Study and Toxicological Effects 44 Cancer (oral, dermal, inhalation) Group C carcinogen Does not require quantification of human cancer risk Based on a dose­ related increase in interstitial cell hyperplasia and adenomas in a two­ year rat feeding study and hepatocellular tumors that appeared in low­ dose male and high­ dose female mice in a two­ year feeding study 1 UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, LOC = level of concern, MOE = margin of exposure

epa

2024-06-07T20:31:41.909409

regulations

EPA-HQ-OPP-2002-0079-0012

Supporting & Related Material

Mr. Dirk Helder April 30, 2002 April 30, 2002 helder. dirk@ epa. gov F 1 703­ 305­ 4610 Mr. Dirk Helder, Linuron Chemical Review Manager U. S. EPA OPP/ SRRD (7508C) 1921 Jefferson Davis Highway Room 266A, Crystal Mall #2 Arlington, VA 22202­ 4501 SUBJECT: LINURON TRED ­ RESPONSE TO DRAFT HED, RESIDUE AND DRINKING WATER CHAPTERS Dear Mr. Helder: The purpose of this letter is to respond to the subject chapters received by GRIFFIN LLC on February 11, 2002. We have reviewed the documents and limited our responses to apparent discrepancies between the studies we have in hand and the draft chapters. Response to: HED Chapter of the Linuron Tolerance Reassessment Eligibility Decision. PC Codes: 035506. Case 0047. DP Barcode D271950. There are several discrepancies in the series of documents prepared to support the Tolerance Reassessment Eligibility Decision of Linuron. Many are basic to the decisions which will be made for additional studies and the risk assessment process. These need to be addressed before any of these reports are published. 1) The first discrepancy is the statement on page 4 that linuron exhibits developmental concerns. On page 3 of the same document it states: Developmental studies in the rat and rabbit showed no quantitative or qualitative susceptibility in the offspring. … These findings do not indicate increased susceptibility because increases in resorptions were marginal and there was no change in the number of live fetuses to corroborate the increase in post­ implantation losses. This is in direct contradiction with the statements that there are developmental toxicity concerns. In addition, the acute dietary endpoint was `derived from the developmental toxicity study in the rat and is based on increases in post­ implantation loss and litter/ fetal resorptions." (page 5) Although the acute dietary endpoint is correctly set at 12.1 mg/ kg/ day, it should be based on the NOEL for maternal toxicity seen in this study at 12.1 mg/ kg/ day. 2) The second error was the use of the 3­ generation rat study. This study was deemed `supplemental' because it was a non­ guideline study. Substantial effort was expended by DuPont, the former registrant, to upgrade this study in the late 1980's. The Agency, after multiple responses, would not consider this study as acceptable or guideline compliant (CAS # 004405, Record # 154,911, CAS# 004819, CAS# 005626, CAS# 008113, CAS# 008612). After a meeting held on July 22, 1987, a new 2­ generation reproduction study in rats was required. No records of additional scientific reviews can be located which reverses this decision. This new 2­ generation study was submitted with subsequent studies to elucidate questionable effects. This study with the amendments was accepted, therefore, this study should be used for regulatory decision­ making and the rejected study discounted. Mr. Dirk Helder April 30, 2002 Page 2 The report states on page 4: A 3­ generational study using rats showed reduced body weights and fertility, decreased pup survival, and decreased weanling body, liver and kidney weights, as well as liver atrophy. The Hazard Identification Assessment Review Committee (HIARC) determined that these results illustrate qualitative susceptibility in the rat offspring. In the discussion of the 3­ generational study in the HED Toxicology Disciplinary Chapter the LOEL for systemic toxicity was established at 125 ppm and the NOEL was set at 25 ppm. The offspring toxicity LOEL was established at 625 ppm with the NOAEL at 125 ppm. This was based on decreased pup survival and lower pup body weights. It is clear that this effect was at maternally toxic levels. This is NOT evidence of a qualitative susceptibility in rat offspring. EPA's position was very clearly stated in the August 15, 1985 rebuttal comments from James N. Rowe. (Record Number 154,911). It states: "It is apparent that gross and histopathological examinations of the adult rats were not performed by the registrant. Therefore, proper interpretation of the reproductive effects observed in the study cannot be performed." In addition, meeting minutes from a discussion between DuPont and the Agency's scientists held on July 22, 1987 (in the public docket) make it clear that in addition to the lack of histopathological data, fewer than 20 animals per group were tested which were fewer than guideline specification. Griffin LLC can only assume an error was made in reviewing the classification of the acceptable/ guideline designation or the study was re­ evaluated and given a new assessment. If there is a new review, the Agency has not notified the registrant. Regardless, a significant discrepancy exists. 3) The third major discrepancy is the determination of a `neurotoxicity' concern. There has never been an Agency concern for neurotoxicity induced by linuron. The Agency previously recognized this in that no acute or subchronic neurotoxicity studies were requested. Linuron has been shown to be an endocrine disruptor. This has never been in question. There is, however, a big difference between the weak anti­ androgenic activity elicited by linuron and `neuroendocrine' effects referred to by the Agency in this document. No data have been presented by the Agency either from registrant sponsored studies or from the literature which would be a basis for a neurotoxicity concern. This designation of "neuroendocrine effects" has no scientific basis and should be either deleted from the document or supported somewhere in the scientific documents. The request for a developmental neurotoxicity test is not supported by the Agency's own assessment of the science. (see discussion above as it relates to the developmental studies) 4) The fourth major discrepancy is the reference with Linuron (and subsequent regulatory action) to linuron as an inhalation concern. There is essentially no toxicity by the inhalation route. The LD50 is >218 mg/ L or 21.8 g/ M 3 . The MOEs calculated in the Linuron RED of March 1995 were all above 100 and of no concern. These were based on the NOELs (12.1 mg/ kg) from the rat developmental study for the short­ term assessment and the 2­ generation reproduction study (1.25 mg/ kg/ day) for the intermediate term assessment. Because the occupational exposure to a pre­ emergent herbicide used once per season/ year will not exceed 30 days exposure, there is not a great inhalation risk concern driven by the use patterns. In addition, linuron is neither volatile as an active ingredient nor contains volatiles nor becomes volatile in its formulations. Given the lack of inhalation toxicity and Mr. Dirk Helder April 30, 2002 Page 3 potential for exposure, the request for a 28­ day inhalation study is not supported. This is either in error or requires scientific justification. Response to EPA Document: Linuron TRED Residue Chemistry Considerations There are two discrepancies in the series of documents prepared to support the Tolerance Reassessment Eligibility Decision of Linuron. Many are basic to the decisions which will be made for additional studies and the risk assessment process. These need to be addressed before any of these reports are published. 5) Page 46. Miscellaneous Commodities "Cotton, seed and gin products For the gin byproducts field trials, information describing the type of equipment used for harvesting in the machine­ harvest trials must be submitted. In addition, additional cotton gin byproducts field trials must be conducted, such that the requirements of GLN 860.1000 (Table 1) for gin byproducts field trials are fulfilled, or a justification for the substitution of data from field trials reflecting hand harvesting must be submitted." A response to the issues raised above was submitted to Mr. Tom Myers, Chemical Review Manager. The letter of transmittal is dated January 14, 2002 and was sent via FedEx on this date. Our records indicate that this response was received on January 16. 6) Page 47. Magnitude of the Residue in Processed Food/ Feed "The 2/ 94 RED and 2/ 95 RED Addendum concluded that additional data were required to upgrade an existing potato processing study (S. Knizner, 9/ 2/ 92); these data remain outstanding." A response to the memorandum from Steven A. Knizer to Lois Rossi was submitted to the Agency on February 14, 2000. Our records show that the response was received by the Agency on February 18, 2000. The information requested for upgrading this study was included in the submittal. Response to Linuron TRED, Drinking Water There are two discrepancies in the series of documents prepared to support the Tolerance Reassessment Eligibility Decision of Linuron. Many are basic to the decisions which will be made for additional studies and the risk assessment process. These need to be addressed before any of these reports are published. Surface Water 7) Model used for estimating residues in drinking water The Agency used the IR­ PCA PRZM/ EXAM model that has never been validated and has been proven to grossly overestimate residues in drinking water. It is stated in the document that "Modeling results are higher than those from existing surface water monitoring data for linuron targeted to the pesticide use area". Percent Crop Area (PCA) was used in the modeling of linuron on carrots. PCA is only applicable to major crops and carrots in the San Joaquin –Tulare Basins is not considered a major crop. Data from the 1992 Census of Agriculture were used to generate the PCA's and recent changes in the agriculture sector has significantly impacted the distribution of crops throughout the US. We feel that the IR­ PCA PRZM/ EXAM model is not a valid modeling system for estimating residues in drinking water and that the inputs into the model are not valid. The results from this model misrepresent the actual residues that Mr. Dirk Helder April 30, 2002 Page 4 occur in drinking water. Monitoring data cited by the Agency much more accurately reflects linuron residues in drinking water. Ground Water 8) The Agency recommended that 5 ppb of linuron be used in the drinking water assessment based on monitoring data cited. It is recommended in this document that 5 ppb be used in the drinking water assessment in ground water. Data cited in the review show that the highest residue in drinking water was 5 ppb. We recommend that the Agency use in their drinking water assessment an average residue from the water monitoring data. Data cited by the Agency from a USGS NAWQA monitoring study show linuron residues were detected in only 0.11% of the 924 samples analyzed. The maximum concentration was 0.029 ppb. In another study cited, linuron residues were present in 29% of the 377 analyses. The highest residue from this monitoring study was 5 ppb. Again, the Agency is using a value that grossly overestimates linuron residues in drinking water. If an average residue value is used, then the estimated exposure would be <1 ppb. Additional monitoring data can be found at the following website: http:// water. wr. usgs. gov/ pnsp/ pestgw/ In this monitoring program, water samples were collected from 1243 wells and 1849 aquifers located in agricultural areas. Linuron residues were detected in 0.16% of the wells and 0.05% of the aquifers. The maximum linuron residue detected in these water samples was 0.03 ppb. Water samples were also collected from 643 wells in urban areas and no residues were detected in any of the water samples analyzed. Please advise if any additional draft Linuron chapters will be distributed. Sincerely yours, Wm. Ronald Landis, Ph. D. Consultant to GRIFFIN, LLC pc: Richard Collier, Ph. D., GRIFFIN, LLC Bill Tweedy, Ph. D., GRIFFIN, LLC Jimmy Lefiles, GRIFFIN, LLC Gail Arce, Ph. D., GRIFFIN, LLC

epa

2024-06-07T20:31:41.922207

regulations

EPA-HQ-OPP-2002-0079-0013

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES PC Code: 035506 DP Barcode: D281893 MEMORANDUM DATE: March 25, 2002 FROM: Ibrahim Abdel­ Saheb, Agronomist ERB II Environmental Fate and Effects Division (7507C) THRU: Tom Baily, Branch Chief ERBII Environmental Fate and Effects Division (7507C) TO: Dirk Helder Chemical Review Manager Special Review and Reregistration Division (7508C) The purpose of this memo is to respond to the comments made by GRIFFIN LLC contained in the document to HED on Draft HED, Residue and Drinking Water Chapters ( February 11, 2002) . EFED has reviewed the comments and concluded that the issues raised by GRIFFIN LLC are not errors but policy and procedure issues. These issues will be addressed in the Public Comments phase.

epa

2024-06-07T20:31:41.926015

regulations

EPA-HQ-OPP-2002-0079-0014

Supporting & Related Material

1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES March 27, 2002 MEMORANDUM SUBJECT: Occupational Exposure and Risk Assessment/ Characterization for the Proposed Use of Linuron on Rhubarb and Celeriac. FROM: Shanna Recore, Industrial Hygienist Reregistration Branch II Health Effects Division (7509C) TO: Carol Christensen, Risk Assessor Reregistration Branch II Health Effects Division (7509C) THROUGH: Alan Nielsen, Branch Senior Scientist Reregistration Branch II Health Effects Division (7509C) Please find the review of Linuron. DP Barcode: D281845 Pesticide Chemical Codes: 035506 EPA Reg Numbers: 1812­ 245, 1812­ 320 PHED: Yes, Version 1.1 Summary 2 Interregional Research Project No. 4 (IR­ 4), on behalf of Griffin Corporation, is proposing two new uses, rhubarb and celeriac, for the herbicides Linex ® 50DF (dry flowable) and Linex ® 4L (liquid) which controls grasses and broadleaf weeds. Linuron may be applied either by ground sprayers or chemigation to rhubarb and celeriac. A maximum of one application of 1.5 lbs active ingredient (ai)/ acre per season is proposed. Based on the proposed use patterns, short­ term dermal and inhalation exposures (1­ 30 days) are expected for private applicators (farmers treating their own crops) and commercial applicators. Since no chemical­ specific data are available to assess potential exposure to workers, the exposure and risk assessment presented in this document are based on the Pesticide Handler Exposure Database Version 1.1 (PHED, Surrogate Exposure Guide, August 1998). The maximum application rate listed on the label was used for all calculations. The standard values for acreage were taken from HED Exposure Science Advisory Committee (Expo SAC) Policy # 9.1, effective September 25, 2001. All calculated Margins of Exposure (MOEs) do not exceed HED's level of concern at the minimum personal protective equipment (PPE) level. Workers having potential post­ application re­ entry exposure to linuron from the proposed use include scouts and workers re­ entering treated fields to perform irrigation and handweeding tasks. Since linuron will be applied at the early stages of crop growth, low potential for post­ application exposure is expected. In order to demonstrate that minimal exposure and risk are expected, a post­ application exposure assessment was done for scouting, handweeding and irrigating. The estimated MOE for these activities related to the proposed use of linuron on rhubarb and celeriac does not exceed HED's level of concern, on the day of application. Use Patterns and Formulations IR­ 4, on behalf of Griffin LLC, has proposed the registration of two new uses, rhubarb and celeriac, for the previously registered herbicides Linex ® 50DF (EPA Reg. No. 1812­ 320) and Linex ® 4L (EPA Reg. No. 1812­ 245). Linex ® 50DF is a dry flowable containing 50% of the ai linuron. Linex ® 4L is a liquid containing 40.6% of the ai linuron. According to the labels, this product is applied as a non­ direct spray to control annual grasses and broadleaf weeds. A maximum of one to two application per season of 0.75 to 1.5 lbs ai/ acre, but no more than 2 lb ai/ acre/ year, may be applied by ground sprayers or by chemigation (Linex ® 4L only). For Linex ® 50DF, applications using irrigation equipment is prohibited. According to the proposed labels, linuron is applied to rhubarb, after harvest but before the regrowth of crop, and to celeriac, before a height of eight inches is reached and before annual grasses exceed two inches in height and before broadleaf weed exceed six inches in height. Table 1 summarizes the proposed linuron use on rhubarb and celeriac. Currently, there are no registered or proposed residential uses of linuron. 4,5 Table 1: Use Pattern Summary of Linuron on Rhubarb and Celeriac 3 Formulation Linex ® 50DF ­ dry flowable Linex ® 4L ­ liquid Pests annual grasses and broadleaf weeds Application methods Linex ® 50DF ­ groundboom sprayer Linex ® 4L ­ groundboom sprayer and chemigation Maximum application rate (AR) 1.5 lbs a. i./ acre (Maximum application per year is 2 lbs ai/ acre) Number of applications per season 1­ 2 Timing/ frequency Rhubarb ­ after harvest but before the regrowth of crop Celeriac ­ before a height of 8 inches is reached and before annual grasses exceed 2 inches in height and before broadleaf weed exceed 6 inches in height Manufacturer Griffin LLC Toxicological Profile Table 2 presents the acute toxicity categories as outlined in the Linuron ­ Report of the Hazard Identification Assessment Review Committee (HIARC). 3 Table 2: Acute Toxicity of Linuron (ai) Guideline No. Study Type MRIDs # Results Toxicity Category 870.110 Acute Oral (Rat) 00027625 LD50 = 2600 mg/ kg III 870.1200 Acute Dermal (Rabbit) 00027625 LD50 > 2,000 mg/ kg III 870.1300 Acute Inhalation (Rat) 00053769 LC50 > 218 mg/ L IV 870.2400 Primary Eye Irritation 42849001 Slight conjunctival redness at 24 hrs; clear at 72 hrs III 870.2500 Primary Skin Irritation 42849002 Not an irritant IV 870.2600 Dermal Sensitization 00146868 Not a sensitizer N/ A The HIARC memorandum, dated November 20, 2001, indicates that there are toxicological endpoints of concern for linuron. The endpoints, and associated uncertainty factors used in assessing the risks for linuron are presented in Table 3. 3 Table 3: Summary of Dose and Toxicological Endpoints for Linuron 4 Exposure Scenario NOAEL (mg/ kg/ day) Effect Study Uncertainty Factors Target MOE Short­ Term Dermal (1­ 30 days) (Occupational/ Residential) Oral NOAEL = 5.8 a Statistically and biologically significant decrease in premating body weights in F0 and F1 animals 2­ Generation Reproduction Study ­ Rat Interspecies: 10x Intraspecies: 10x FQPA: 10x Occupational: 100 IntermediateTerm Dermal (1 ­ 6 months) (Occupational/ Residential) Oral NOAEL = 0.77 a Increased met­ and sulfhemoglobin levels after 3 and 6 months of treatment Chronic Feeding Study ­ Dog Interspecies: 10x Intraspecies: 10x FQPA: 10x Occupational: 100 Long­ Term Dermal (Longer than 6 months) (Occupational/ Residential) Oral NOAEL = 0.77 a Increased met­ and sulfhemoglobin levels Chronic Feeding Study ­ Dog Interspecies: 10x Intraspecies: 10x FQPA: 10x Occupational: 100 Short­ Term Inhalation (1­ 30 days) (Occupational/ Residential) Oral NOAEL = 5.8 b statistically and biologically significant decrease in premating body weights in F0 and F1 animals 2­ Generation Reproduction Study ­ Rat Interspecies: 10x Intraspecies: 10x FQPA: 10x Occupational: 100 IntermediateTerm Inhalation (1 to 6 months) (Occupational/ Residential) Oral NOAEL = 0.77 b Increased met­ and sulfhemoglobin levels Chronic Feeding Study ­ Dog Interspecies: 10x Intraspecies: 10x FQPA: 10x Occupational: 100 Long­ Term Inhalation (Longer than 6 months) (Occupational/ Residential) Oral NOAEL= 0.77 b Increased met­ and sulfhemoglobin levels Chronic Feeding Study ­ Dog Interspecies: 10x Intraspecies: 10x FQPA: 10x Occupational: 100 Footnote a = Assume 16% dermal absorption for route­ to­ route extrapolation b = Assume 100% inhalation absorption for route­ to­ route extrapolation FQPA Safety Factor The FQPA Safety Factor Committee memorandum, dated December 6, 2001, 5 recommended that the FQPA safety factor be retained at 10x for the following weight­ ofevidence considerations: ° a qualitative increase in susceptibility seen in the F1 males in the rat reproductive toxicity study; and ° a developmental neurotoxicity study in rats is required for the chemical because linuron is a potential endocrine disruptor and there is evidence for testicular lesions and decreased fertility in the rat reproductive toxicity study. However, the Committee concluded that the safety factor could be reduced to 3x for linuron because: ° the toxicology database is complete; ° the dietary (food and water) exposure assessments will not underestimate the potential exposures for infants, children, and/ or women of childbearing age; and ° there are no residential uses. When assessing acute dietary exposure of females 13­ 50 years of age, the safety factor should be reduced to 3x since the developmental neurotoxicity study in rats is required and may further define the neurotoxic (neuro­ endocrine) potential observed in rats that were exposed in pre­ and post­ natal time periods. However, when assessing chronic dietary exposure to all other population sub­ groups, the safety factor should be retained at 10x since there is concern for the qualitative increase in susceptibility observed in the rat reproductive toxicity study (a long­ term study), and, since the developmental neurotoxicity study in rats is required. The developmental neurotoxicity study may further define the neurotoxic (neuro­ endocrine) potential observed in rats due to pre­ and post­ natal exposure. 2 Cancer Determination The RfD/ Peer Review Committee has classified linuron as an unquantifiable Group C carcinogen (a possible human carcinogen for which there is limited animal evidence) requiring no quantification of human cancer risk. Occupation Exposure Assessment Occupational Handler Exposures and Risk Estimates PHED Since no chemical­ specific data are available to assess potential exposure to workers, the exposure and risk assessment presented in this document are based on the Pesticide Handlers Exposure Database (PHED) Version 1.1. It is the policy of the HED to use data from PHED to assess handler exposures for regulatory actions when chemical­ specific monitoring data are not available. 7 6 PHED was designed by a task force of representatives from the U. S. EPA, Health Canada, the California Department of Pesticide regulation, and member companies of the American Crop Protection Association. PHED is a software system consisting of two parts ­­ a database of measured exposure values for workers involved in the handling of pesticides under actual field conditions and a set of computer algorithms used to subset and statistically summarize the selected data. Currently, the database contains values for over 1,700 monitored individuals (i. e., replicates). Users select criteria to subset the PHED database to reflect the exposure scenario being evaluated. The subsetting algorithms in PHED are based on the central assumption that the magnitude of handler exposures to pesticides are primarily a function of activity (e. g., mixing/ loading, applying), formulation type (e. g., wettable powders, granulars), application method (e. g., aerial, groundboom), and clothing scenarios (e. g., gloves, double layer clothing). Once the data for a given exposure scenario have been selected, the data are normalized (i. e., divided by) by the amount of pesticide handled resulting in standard unit exposures (milligrams of exposure per pound of active ingredient handled). Following normalization, the data are statistically summarized. The distribution of exposure values for each body part (e. g., chest upper arm) is categorized as normal, lognormal, or "other" (i. e., neither normal nor lognormal). A central tendency value is then selected from the distribution of the exposure values for each body part. These values are the arithmetic mean for normal distributions, the geometric mean for lognormal distributions, and the median for all "other" distributions. Once selected, the central tendency values for each body part are composited into a "best fit" exposure value representing the entire body. The unit exposure values calculated by PHED generally range from the geometric mean to the median of the selected data set. To add consistency and quality control to the values produced from this system, the PHED Task Force has evaluated all data within the system and has developed a set of grading criteria to characterize the quality of the original study data. The assessment of data quality is based on the number of observations and the available quality control data. These evaluation criteria and the caveats specific to each exposure scenario are summarized in Table 6. While data from PHED provide the best available information on handler exposures, it should be noted that some aspects of the included studies (e. g., duration, acres treated, pounds of active ingredient handled) may not accurately represent labeled uses in all cases. HED has developed a series of tables of standard unit exposure values for many occupational scenarios that can be utilized to ensure consistency in exposure assessments. 6 7 Occupational Handler Exposure Scenarios HED has determined that there are potential exposures to mixer, loader, applicator and other handlers during the usual use­ patterns associated with linuron. Based on the use patterns, three major occupational exposure scenarios were identified for linuron: (1a) mixing/ loading liquids for ground application; (1b) mixing/ loading liquids for chemigation application; (2) mixing/ loading dry flowable for ground application; and (3) applying liquids with groundboom sprayer. The current Linex ® 50DF and Linex ® 4L labels have the following PPE requirements for handlers: coveralls over short­ sleeved shirt and short pants, waterproof gloves, shoes plus socks, and chemical­ resistant headgear for overhead exposures. Assumptions for Handler Exposure Scenarios The following assumptions and factors were used in order to complete this exposure assessment: C average body weight of an adult handler is 70 kg; ° average work day interval represents an 8 hour workday (e. g., the acres treated or volume of spray solution prepared in a typical day); ° for groundboom equipment use on rhubarb and celeriac, 80 acres per day was used to assess handler exposure; 8 ° for chemigation application to rhubarb and celeriac, 350 acres per day was used; 8 ° aerial application will be prohibited on the label for application to rhubarb and celeriac; ° calculations are completed at the maximum application rates for crops as stated on the designated linuron labels; and ° due to a lack of scenario­ specific data, HED calculates unit exposure values using generic protection factors that are applied to represent various risk mitigation options (i. e., the use of PPE and engineering controls). 8 Occupational Handler Exposures and Non­ Cancer Risk Assessment Equations to Calculate Handler Exposure Daily dermal exposure is calculated using the following formula: Daily inhalation exposure is calculated using the following formula: The daily dermal and inhalation dose is calculated as follows using a 70 kg body weight: The dermal and inhalation MOEs were calculated using the following formulas: Based on the available toxicity data, it is appropriate to combine short­ term dermal and inhalation MOEs because the effects observed at the LOAEL were identical. The total MOE 9 were calculated using the following formula: Based on the proposed use patterns, short­ term (1 to 30 days) dermal and inhalation exposures are expected for private applicators (farmers treating their own crops) and commercial applicators. Since linuron may be applied only one to two times per year and has a limited crop production (for celeriac ­ only 750 acres are grown in the United States; for rhubarb ­ only 860 acres are grown in the United States), intermediate­ term (30 days to 6 months) and long­ term (longer than 6 months) exposures are not expected from the proposed use. Table 4 presents the summary of occupational handler short­ term (1­ 30 days) dermal and inhalation exposures at baseline, with additional personal protective equipment, and with engineering controls. Table 5 lists the caveats and parameters specific to the surrogate data used for each scenario and corresponding exposure/ risk assessment. See appendix tables A, B, C, and D for additional information. 10 Table 4. Summary of Occupational Handler Short­ term Dermal and Inhalation Total Exposure Variables Exposure Scenario (Scenario #) Crop Application rates a Area Treated Total Short­ term MOE Baseline b, f Total Short term MOE Min PPE c, f Total Short term MOE Max PPE d, f Total Short term MOE Eng. Control e, f Mixer/ Loader Mixing/ Loading Liquids for Groundboom application (1a) Rhubarb and Celeriac 1.50 lb ai per acre 80 Acres per day 7. 3 860 ­ Mixing/ Loading Liquids for Chemigation application (1b) Rhubarb and Celeriac 1.50 lb ai per acre 350 Acres per day 1. 7 200 ­ Dry Flowables for Groundboom application (2) Rhubarb and Celeriac 1.50 lb ai per acre 80 Acres per day 300 ­ ­ Applicator Sprays for Groundboom application (3) Rhubarb and Celeriac 1.50 lb ai per acre 80 Acres per day 1100 ­ ­ Footnotes : a Application Rates are based on the maximum application rates listed on the proposed linuron labels. b Baseline dermal unit exposure represents long pants, long sleeved shirt, no gloves, open mixing/ loading, open cab tractor and baseline inhalation unit exposure represents no respirator 8 . c Minimum PPE for all dermal scenarios include chemical resistant gloves (90% Protection Factor) and minimum PPE for all inhalation scenarios include a dust/ mist respirator (5­ fold Protection Factor). d Maximum PPE for all dermal scenarios include double layer of clothing (50% Protection Factor for clothing) and chemical resistant gloves (90% Protection Factor) and maximum PPE for all inhalation scenarios include an organic vapor respirator (90% Protection Factor). e Engineering Controls for mixer/ loader include closed mixing/ loading, single layer clothing and scenario 1a and 1b also include chemical resistant gloves. Engineering Controls for applicators and flaggers include enclosed cockpit, cab or truck, single layer clothing, no gloves. f Total MOE (combined dermal and inhalation) = 1 / (( 1/ dermal MOE) + (1/ inhalation MOE)) ­ Scenario's calculated MOE exceeds the target MOE at the previous level of mitigation (MOE> 100) Table 5. Occupational Handler Exposure Scenario Descriptions for the Use of Linuron 11 Exposure Scenario (Scenario Number) Data Source Standard Assumption a (8­ hr work day) Comments b MIXER/ LOADER DESCRIPTORS Mixing/ Loading Liquid Formulations (1a, b) PHED V1.1 ° 80 acres for groundboom to rhubarb and celeriac ° 350 acres for chemigation application to rhubarb and celeriac Baseline: Hand, dermal, and inhalation data are AB grades. Hand = 72 to 122 replicates; dermal = 53 replicates; and inhalation = 85 replicates. High confidence in hand/ dermal and inhalation data. No protection factor was needed to define the unit exposure value. PPE: The same dermal and inhalation data are used as for the baseline coupled with a 50% protection factor to account for an additional layer of clothing, and an 80% protection factor to account for the use of a dust/ mist respirator and 90% protection factor to account for the use of an organic vapor respirator, respectively. Hand data are AB grades, with 59 replicates. High confidence in hand/ dermal data. Engineering Controls: Hand, dermal, and inhalation data are AB grades. Hand = 31 replicates; dermal =16 to 22 replicates; inhalation = 27 replicates. High confidence in hand/ dermal and inhalation data. Mixing/ Loading Dry Flowable Formulations (2) PHED V1.1 ° 80 acres for groundboom to rhubarb and celeriac Baseline: Hand, dermal and inhalation data are AB grades. Hand = 7 replicates; dermal = 16 to 26 replicates; and inhalation = 23 replicates. Low confidence in hand/ dermal data and high confidence in inhalation data. PPE: Hand/ dermal data are AB grades. The same inhalation data are used as for the baseline coupled with an 80% protection factor to account for the use of a dust/ mist respirator and 90% protection factor to account for the use of an organic vapor respirator. Hand = 21 replicates and dermal = 16 to26 replicates. High confidence in hand/ dermal data. Engineering Controls: No data APPLICATOR DESCRIPTORS Applying Sprays with a Groundboom Sprayer (3) PHED V1.1 ° 80 acres for groundboom to rhubarb and celeriac Baseline: Hand, dermal, and inhalation data are AB grades. Hand = 29 replicates; dermal = 23 to 42 replicates; and inhalation = 22 replicates. High confidence in hand/ dermal and inhalation data. No protection factor was needed to define the unit exposure value. PPE: The same dermal and inhalation data are used as for the baseline coupled with a 50% protection factor to account for an additional layer of clothing, and an 80% protection factor to account for the use of a dust/ mist respirator and 90% protection factor to account for the use of an organic vapor respirator, respectively. Hand data are ABC grades, with 21 replicates. Medium confidence in hand/ dermal data. Engineering Controls: Hand and dermal data are ABC grades, and inhalation are AB grades. Hand = 16 replicates; dermal =20 to 31 replicates; inhalation = 16 replicates. Medium confidence in hand/ dermal data, and high confidence in inhalation data. Footnotes a Standard Assumptions based on an 8­ hour work day as estimated by HED. BEAD data were not available. b All handler exposure assessments in this document are based on the "Best Available" data as defined by OREB SOP for meeting Subdivision U Guidelines. Best available grades are assigned to data as follows: matrices with grades A and B data and a minimum of 15 replicates; if not available, then grades A, B and C data and a minimum of 15 replicates; if not available, then all data regardless of the quality (i. e., All Grade Data) and number of replicates. High quality data with a protection factor take precedence over low quality data with no protection factor. Generic data confidence categories are assigned as follows: 12 High = grades A and B and 15 or more replicates per body part Medium = grades A, B, and C and 15 or more replicates per body part Low = grades A, B, C, D and E or any combination of grades with less than 15 replicates Summary of Non­ Cancer Risk Concerns for Occupational Handlers For the dermal and inhalation, short­ term exposure, the target MOE is 100. The calculated dermal and inhalation MOE values were combined for short­ term because the dermal and inhalation endpoints were the same. MOEs are calculated for all scenarios at baseline, minimum PPE, maximum PPE, and engineering control level exposures. Baseline Level The calculations of short­ term combined dermal and inhalation risk indicate that the only scenarios with MOEs that are less than the target MOE of 100 at the baseline level are the following: ° (1a) mixing/ loading liquids for groundboom application to rhubarb and celeriac at 80 acres per day; and ° (1b) mixing/ loading liquids for chemigation application to rhubarb and celeriac at 350 acres per day. Additional PPE The calculations of short­ term combined dermal and inhalation risk indicate that all the scenarios have MOEs that exceed the target MOE of 100 at the additional PPE level. Engineering Controls The calculations of short­ term combined dermal and inhalation risk indicate that all the scenarios have MOEs that exceed the target MOE of 100 at the engineering control level. Occupational Handler Exposure and Risk Estimates for Cancer Linuron cancer classification is "Suggestive evidence of carcinogenic potential by all routes of exposure, but not sufficient to assess human carcinogenic potential" therefore a occupational handler cancer assessment was not conducted. Occupational Post Application Exposures and Non­ Cancer Risk Estimates Linuron is in toxicity category III and IV for the dermal route of exposure, primary eye irritation, and primary skin irritation. Linuron is not a dermal sensitizer. Based on the Worker 13 Protection Standard (WPS), an interim REI of 12 hours is sufficient to protect workers performing re­ entry activities for the proposed use of linuron. The WPS prohibits routine entry to perform hand labor tasks during the REI and requires PPE to be worn for other early­ entry tasks that require contact with treated surfaces. The linuron labels specify the following early entry PPE: coveralls over short­ sleeved shirt and short pants, waterproof gloves, shoes, socks, and chemical resistant headgear for overhead exposure. The transfer coefficients used in this assessment for the use on rhubarb and celeriac are from the Agricultural Re­ entry Task Force (ARTF) database. An interim transfer coefficient policy was developed by HED's Science Advisory Council for Exposure using the ARTF database. It is the intention of HED's Science Advisory Council for Exposure that this policy will be periodically updated to incorporate additional information about agricultural practices in crops and new data on transfer coefficients. Much of this information will originate from exposure studies currently being conducted by the ARTF, from the further analysis of studies already submitted to the Agency, and from the studies in the published scientific literature. 8,9 Although rhubarb and celeriac are not specifically listed in the EPA Policy 3.1, the transfer coefficient for celery, a similar crop, was used as a surrogate. The rhubarb and celeriac surrogate assessments use a low transfer coefficient of 500 cm 2 /hr for activities such as scouting during minimal foliage development. 8 The linuron labels indicates that it is applied pre­ emergent to rhubarb and post­ emergent but before a height of eight inches is reached to celeriac. 4,5 Therefore, the high transfer coefficient for activities, such as scouting during full foliage, will not be used. No chemical specific dislodgeable foliar residue (DFR) or turf transferable residue (TTR) data exist. The DFR is derived from using an estimated 20 percent of the rate applied as initial dislodgeable residues for rhubarb and celeriac. An estimated 10 percent dissipation rate per day for rhubarb and celeriac. The duration of postapplication exposure is assumed to be short­ term. The equations used to calculate the post­ application in Table 6 are presented below: Surrogate DFR calculation (rhubarb and celeriac): Where: AR = Application rate (1.5 lbs ai/ acre for rhubarb and celeriac) DR = Daily dissipation rate (10 percent/ day) t = Days after treatment CF = Conversion factor (11.2 µg per cm 2 /lb ai per A) F = Fraction retained on foliage (20% for rhubarb and celeriac) 14 Dose calculation: Where: DFR = Initial DFR or daily DFR (µg/ cm 2 ) Tc = Transfer coefficient (500 cm 2 /hr for rhubarb and celeriac) CF = Conversion factor (1 mg/ 1,000 µg) ED = Exposure duration (8 hours per day) BW = Body weight (70 kg) Where: NOAEL = 5.8 mg/ kg/ day Dose = Calculated dose (mg/ kg/ day) Occupational Post­ application Non­ cancer Risk Summary For non­ cancer risks, the calculated MOE for rhubarb and celeriac exceeds the target MOE on the day of application for activities such as handweeding, scouting, and irrigating (see table 6). 15 Table 6. Linuron Non­ Cancer Post application Assessment Crop Maximum Label Application Rate (lbs ai/ acre) a Transfer Coefficient b (cm 2 /hr) Activity c DAT d DFR e (µg/ cm 2 ) MOE f Rhubarb and Celeriac 1.5 500 hand weeding, scouting, and irrigating 0 (12 hours) 3.36 190 Footnotes: a Maximum application rates as proposed for linuron use on rhubarb and celeriac. b Transfer Coefficients from Science Advisory Council on Exposure Policy 3.1. 7 c Activities from Science Advisory Council on Exposure Policy 3.1. 7 Every activity listed may not occur for every crop in the group. d DAT is "days after treatment" e Initial DFR (µg/ cm 2 ) = Application rate (lbs ai/ A) x Conversion factor (1 lb ai/ acre= 11.209 µg/ cm2) x Fraction of initial ai retained on foliage (20%) f MOE = NOAEL (mg/ kg/ day) / Dermal dose (mg/ kg/ day). Target MOE = 100. Occupational Post­ application Exposure and Risk Estimates for Cancer Linuron was classified as an unquantifiable Group C carcinogen (a possible human carcinogen for which there is limited animal evidence) requiring no quantification of human cancer risk; therefore, an occupational handler cancer assessment was not conducted. Residential Exposure and Risks Spray drift is always a potential source of exposure to residents nearby to spraying operations. This is particularly the case with aerial application, but to a lesser extent, groundboom application methods could also be a potential source of exposure. The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and State Lead Agencies for pesticide regulation and other parties to develop the best spray drift management practices. The Agency is now requiring interim mitigation measures for aerial applications that must be placed on product labels/ labeling. The Agency has completed its evaluation of the new data base submitted by the Spray Drift Task Force, a membership of U. S. pesticide registrants, and is developing a policy on how to appropriately apply the data and the AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard airblast and ground hydraulic methods. After the policy is in place, the Agency may impose further refinements in spray drift management practices to reduce off­ target drift and risks associated with aerial as well as other application types where appropriate. HED has determined that, other than the possibility of spray drift exposure, there are no potential post­ application exposures to residents because linuron is not used in any residential areas. 16 Incident Reports The Agency searched several databases for reports of poisoning incident data for linuron. These databases include the OPP Incident Data System, the Poison Control Centers database, the California Department of Pesticide Regulation, and the National Pesticide Telecommunications Network. Relatively few incidents of illness have been reported. Three cases were submitted to the California Pesticide Illness Surveillance Program (1982­ 1999) concerning possible linuron poisoning. Effects reported in these cases include chemical conjuctivitis when linuron was splashed into the eyes, headache, nausea, swollen tongue and blurred vision, and itchy hives. According to the fifth edition of "Recognition and Management of Pesticide Poisonings" (EPA 1999), systemic toxicity is unlikely unless large amounts have been ingested. No recommendations can be made based on the few incident reports available for linuron. 1 17 References 1. Blondell, J. and M. Spann (2001) Review of Linuron Incident Reports DP Barcode D280196, Chemical #035506. U. S. Environmental Protection Agency, Office of Pesticide Programs. January 11, 2001. 2. Christensen, C. (2001) Linuron ­ Report of the FQPA Safety Factor Committee. Washington, D. C.: U. S. Environmental Protection Agency, Office of Pesticide Programs. December 6, 2001. 3. Fricke, R. (2001) Linuron: Report of the Hazard Identification Assessment Review Committee. Washington, D. C.: U. S. Environmental Protection Agency, Office of Pesticide Programs. November 20, 2001. 4. Interregional Research Project No. 4 (1998) Petition Re: Linuron/ Rhubarb/ PR#­ 06591, New Use, No date for review. Interregional Research Project No. 4. Center for Minor Crop Pest Management. Letter from Edith Lurvey (IR­ 4) to Hoyt Jamerson (MUERIB/ RD/ OPP), August 20, 1998. 5. Interregional Research Project No. 4 (1998) Petition Re: Linuron/ Celeriac/ PR#­ 03557, New Use, No date for review. Interregional Research Project No. 4. Center for Minor Crop Pest Management. Letter from Edith Lurvey (IR­ 4) to Hoyt Jamerson (MUERIB/ RD/ OPP), August 20, 1998. 6. U. S. EPA (1998) PHED Surrogate Exposure Guide, Version 1.1. Washington, D. C.: U. S. Environmental Protection Agency, Office of Pesticide Programs. August 1998. 7. U. S. EPA (1999) Use of Values from the PHED Surrogate Table and Chemical­ specific Data, Science Advisory Council for Exposure Policy No. 7. Washington, D. C.: U. S. Environmental Protection Agency, Office of Pesticide Programs. January 28, 1999. 8. U. S. EPA (2001) Agricultural Transfer Coefficients, Science Advisory Council for Exposure Policy No. 3.1. Washington, D. C.: U. S. Environmental Protection Agency, Office of Pesticide Programs. August 7, 2000. 9. U. S. EPA (2001) Revised ­ Standard Values for Daily Acres Treated in Agriculture, Science Advisory Council for Exposure Policy No. 9.1. Washington, D. C.: U. S. Environmental Protection Agency, Office of Pesticide Programs. September 25, 2001. 18 Appendix 19 Table A. Occupational Handler Short­ Term Risk to Linuron at Baseline Exposure Scenario (Scenario #) Dermal Unit Exposure (mg/ lb ai) a Inhalation Unit Exposure b (Ug/ lb ai) Crop Application Rate c Amount Treated Dermal Dose (mg/ kg/ day) d Dermal MOE e Inhalation Dose (mg/ kg/ day) f Inhalation MOE g Total MOE h Mixer/ Loader Mixing/ Loading Liquids for Groundboom application (1) 2.9 1. 2 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.80 7 0. 0021 2800 7.3 Dry Flowables for Groundboom application (2) 0.066 0.77 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.018 320 0.0013 4400 300.0 Mixing/ Loading Liquids for Chemigation application (3) 2.9 1. 2 Rhubarb, Celeriac 1.50 lb ai per acre 350 Acres per day 3.5 2 0.009 640 1.7 Applicator Sprays for Groundboom application (4) 0.014 0.74 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.0038 1500 0.0013 4600 1100.0 Footnotes: a Baseline dermal unit exposure represents long pants, long sleeved shirt, no gloves, open mixing/ loading, and open cab tractor b Baseline inhalation unit exposure represents no respirator. c Application rates are based on the maximum application rates listed on the proposed linuron labels. d Daily Dermal Dose (mg/ kg/ day) = Dermal Unit Exposure (mg/ lb ai)* Application Rate (lb ai/ acre)* Amount Treated (acres/ day)* dermal absorption (16%)/ Body Weight (70 kg)). e Dermal MOE = NOAEL (5.8 mg/ kg/ day) / Daily Dermal Dose (mg/ kg/ day) . The target MOE value is 100. f Daily Inhalation Dose (mg/ kg/ day) = (Inhalation Unit Exposure (mg/ lb ai) * Application Rate (lb ai/ acre) * Amount Treated (acres/ day)* 1mg/ 1000µg) / Body weight (70kg). g Inhalation MOE = NOAEL (5.8 mg/ kg/ day) / Daily Inhalation Dose (mg/ kg/ day). The target MOE value is 100. h Total MOE (combined dermal and inhalation) = 1 / (( 1/ dermal MOE) + (1/ inhalation MOE)). The target MOE value is 100. 20 Table B. Occupational Handler Short­ Term Risk to Linuron with Minimum PPE Exposure Scenario (Scenario #) Dermal Unit Exposure (mg/ lb ai) a Inhalation Unit Exposure b (Ug/ lb ai) Crop Application Rate c Amount Treated Dermal Dose (mg/ kg/ day) d Dermal MOE e Inhalation Dose (mg/ kg/ day) f Inhalation MOE g Total MOE h Mixer/ Loader Mixing/ Loading Liquids for Groundboom application (1) 0.023 0.24 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.0063 920 0.00041 14000 860.0 Dry Flowables for Groundboom application (1b) 0.066 0.15 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.018 320 0.00026 23000 320.0 Mixing/ Loading Liquids for Chemigation application (2) 0.023 0.24 Rhubarb, Celeriac 1.50 lb ai per acre 350 Acres per day 0.028 210 0.0018 3200 200.0 Applicator Sprays for Groundboom application (3) 0.014 0.15 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.0038 1500 0.00026 23000 1400.0 Footnotes : a Baseline dermal unit exposure represents long pants, long sleeved shirt, no gloves, open mixing/ loading, and open cab tractor b Baseline inhalation unit exposure represents no respirator. c Application rates are based on the maximum application rates listed on the proposed linuron labels. d Daily Dermal Dose (mg/ kg/ day) = Dermal Unit Exposure (mg/ lb ai)* Application Rate (lb ai/ acre)* Amount Treated (acres/ day)* dermal absorption (16%)/ Body Weight (70 kg)). e Dermal MOE = NOAEL (5.8 mg/ kg/ day) / Daily Dermal Dose (mg/ kg/ day) . The target MOE value is 100. f Daily Inhalation Dose (mg/ kg/ day) = (Inhalation Unit Exposure (mg/ lb ai) * Application Rate (lb ai/ acre) * Amount Treated (acres/ day)* 1mg/ 1000µg) / Body weight (70kg). g Inhalation MOE = NOAEL (5.8 mg/ kg/ day) / Daily Inhalation Dose (mg/ kg/ day). The target MOE value is 100. h Total MOE (combined dermal and inhalation) = 1 / (( 1/ dermal MOE) + (1/ inhalation MOE)). The target MOE value is 100. 21 Table C. Occupational Handler Short­ Term Risk to Linuron with Maximum PPE Exposure Scenario (Scenario #) Dermal Unit Exposure (mg/ lb ai) a Inhalation Unit Exposure b (Ug/ lb ai) Crop Application Rate c Amount Treated Dermal Dose (mg/ kg/ day) d Dermal MOE e Inhalation Dose (mg/ kg/ day) f Inhalation MOE g Total MOE h Mixer/ Loader Mixing/ Loading Liquids for Groundboom application (1) 0.017 0.12 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.0047 1200 0.00021 28000 1200.0 Dry Flowables for Groundboom application (1b) 0.047 0.077 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.013 450 0.00013 44000 450.0 Mixing/ Loading Liquids for Chemigation application (2) 0.017 0.12 Rhubarb, Celeriac 1.50 lb ai per acre 350 Acres per day 0.020 280 0.0009 6400 270.0 Applicator Sprays for Groundboom application (3) 0.011 0.074 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.0030 1900 0.00013 46000 1800.0 Footnotes : a Baseline dermal unit exposure represents long pants, long sleeved shirt, no gloves, open mixing/ loading, and open cab tractor b Baseline inhalation unit exposure represents no respirator. c Application rates are based on the maximum application rates listed on the proposed linuron labels. d Daily Dermal Dose (mg/ kg/ day) = Dermal Unit Exposure (mg/ lb ai)* Application Rate (lb ai/ acre)* Amount Treated (acres/ day)* dermal absorption (16%)/ Body Weight (70 kg)). e Dermal MOE = NOAEL (5.8 mg/ kg/ day) / Daily Dermal Dose (mg/ kg/ day) . The target MOE value is 100. f Daily Inhalation Dose (mg/ kg/ day) = (Inhalation Unit Exposure (mg/ lb ai) * Application Rate (lb ai/ acre) * Amount Treated (acres/ day)* 1mg/ 1000µg) / Body weight (70kg). g Inhalation MOE = NOAEL (5.8 mg/ kg/ day) / Daily Inhalation Dose (mg/ kg/ day). The target MOE value is 100. h Total MOE (combined dermal and inhalation) = 1 / (( 1/ dermal MOE) + (1/ inhalation MOE)). The target MOE value is 100. 22 Table D. Occupational Handler Short­ Term Risk to Linuron with Engineering Controls Exposure Scenario (Scenario #) Dermal Unit Exposure (mg/ lb ai) a Inhalation Unit Exposure b (Ug/ lb ai) Crop Application Rate c Amount Treated Dermal Dose (mg/ kg/ day) d Dermal MOE e Inhalation Dose (mg/ kg/ day) f Inhalation MOE g Total MOE h Mixer/ Loader Mixing/ Loading Liquids for Groundboom application (1) 0.0086 0.083 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.0024 2500 0.00014 41000 2300.0 Dry Flowables for Groundboom application (1b) No Data No Data Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day No Data No Data No Data No Data Mixing/ Loading Liquids for Chemigation application (2) 0.0086 0.083 Rhubarb, Celeriac 1.50 lb ai per acre 350 Acres per day 0.010 560 0.00062 9300 530.0 Applicator Sprays for Groundboom application (3) 0.005 0.043 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.0014 4200 0.000074 79000 4000.0 Footnotes : a Baseline dermal unit exposure represents long pants, long sleeved shirt, no gloves, open mixing/ loading, and open cab tractor b Baseline inhalation unit exposure represents no respirator. c Application rates are based on the maximum application rates listed on the proposed linuron labels. d Daily Dermal Dose (mg/ kg/ day) = Dermal Unit Exposure (mg/ lb ai)* Application Rate (lb ai/ acre)* Amount Treated (acres/ day)* dermal absorption (16%)/ Body Weight (70 kg)). e Dermal MOE = NOAEL (5.8 mg/ kg/ day) / Daily Dermal Dose (mg/ kg/ day) . The target MOE value is 100. f Daily Inhalation Dose (mg/ kg/ day) = (Inhalation Unit Exposure (mg/ lb ai) * Application Rate (lb ai/ acre) * Amount Treated (acres/ day)* 1mg/ 1000µg) / Body weight (70kg). g Inhalation MOE = NOAEL (5.8 mg/ kg/ day) / Daily Inhalation Dose (mg/ kg/ day). The target MOE value is 100. h Total MOE (combined dermal and inhalation) = 1 / (( 1/ dermal MOE) + (1/ inhalation MOE)). The target MOE value is 100.

epa

2024-06-07T20:31:41.928707

regulations

EPA-HQ-OPP-2002-0079-0015

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES April 16, 2002 MEMORANDUM: Response to Comment Document ­ Phase II LINURON: The HED Chapter of the Tolerance Reassessment Eligibility Decision (TRED) PC Code (035506). Case 0047. DP Barcode D281779 FROM: Carol Christensen, Risk Assessor Reregistration Branch II Health Effects Division (7509C) THRU: Alan Nielsen, Branch Senior Scientist Reregistration Branch II Health Effects Division (7509C) TO: Dirk Helder Chemical Review Manager Reregistration Branch II Special Review and Reregistration Division (7508W) The attached document was generated in response to the comments received from the Linuron registrant Griffin Chemical on March 11 th , 2002. This document was generated as part of Phase II (error­ only) of the Interim Public Participation Process. The comments pertain to the 3­( 3,4­ dichlorophenyl)­ 1­ methoxy­ 1­ methylurea or linuron TRED document dated January 30, 2002. HED has acknowledged these comments in the Response to Comment document as well as in an updated version of the HED Chapter of the Linuron TRED document. The responses documented here reflect the Agency's current guidelines and policies concerning risk assessment. This document and the updated HED chapter includes replies from John Punzi on residue chemistry and dietary risk assessment and Robert Fricke concerning toxicology, as well as risk assessment and characterization corrections by Carol Christensen. Toxicological Considerations: 2 Registrant Comment 1: The first discrepancy is the statement on page 4 that linuron exhibits developmental concerns. On page 3 of the same document it states: Developmental studies in the rat and rabbit showed no quantitative or qualitative susceptibility in the offspring. … These findings do not indicate increased susceptibility because increases in resorptions were marginal and there was no change in the number of live fetuses to corroborate the increase in post­ implantation losses. This is in direct contradiction with the statements that there are developmental toxicity concerns. In addition, the acute dietary endpoint was `derived from the developmental toxicity study in the rat and is based on increases in post­ implantation loss and litter/ fetal resorptions." (page 5) Although the acute dietary endpoint is correctly set at 12.1 mg/ kg/ day, it should be based on the NOEL for maternal toxicity seen in this study at 12.1 mg/ kg/ day. Agency Response 1: The following statement in the Hazard Identification and Review Committee (HIARC) report and the HED Chapter of the TRED and is correct. "The findings... increases in resorptions were marginal and there was no change in the number of live fetuses to corroborate the increase in post­ implantation losses." The HIARC felt that the fetal effects were not severe enough to be indicative of qualitative susceptibility. If the fetal effects were more severe, linuron may have shown qualitative susceptibility, even if there was no evidence of quantitative susceptibility (fetal and maternal effects occurred at the same dose). There were toxic effects seen in the developmental toxicity study, however, these effects do not include increased susceptibility of fetuses. For determination of the Acute RfD, the HIARC concluded that the developmental effects were presumed to occur following a single exposure of females of child­ bearing age and, therefore, are appropriate for this risk assessment. The reduced body weights and food consumption observed in the maternal animals were not a result of a single exposure. If the fetal NOAEL were higher than the maternal NOAEL, the fetal NOAEL would still be used in establishing the Acute RfD. Therefore, this study and endpoint are appropriate to the acute dietary endpoint. Registrant Comment 2: The second error was the use of the 3­ generation rat study. This study was deemed `supplemental' because it was a non­ guideline study. Substantial effort was expended by DuPont, the former registrant, to upgrade this study in the late 1980's. The Agency, after multiple responses, would not consider this study as acceptable or guideline compliant (CAS # 004405, Record # 154,911, CAS# 004819, CAS# 005626, CAS# 008113, CAS# 008612). After a meeting held on July 22, 1987, a 3 new 2­ generation reproduction study in rats was required. No records of additional scientific reviews can be located which reverses this decision. This new 2­ generation study was submitted with subsequent studies to elucidate questionable effects. This study with the amendments was accepted, therefore, this study should be used for regulatory decision­ making and the rejected study discounted. The report states on page 4: A 3­ generational study using rats showed reduced body weights and fertility, decreased pup survival, and decreased weanling body, liver and kidney weights, as well as liver atrophy. The Hazard Identification Assessment Review Committee (HIARC) determined that these results illustrate qualitative susceptibility in the rat offspring. In the discussion of the 3­ generational study in the HED Toxicology Disciplinary Chapter the LOEL for systemic toxicity was established at 125 ppm and the NOEL was set at 25 ppm. The offspring toxicity LOEL was established at 625 ppm with the NOAEL at 125 ppm. This was based on decreased pup survival and lower pup body weights. It is clear that this effect was at maternally toxic levels. This is NOT evidence of a qualitative susceptibility in rat offspring. EPA's position was very clearly stated in the August 15, 1985 rebuttal comments from James N. Rowe. (Record Number 154,911). It states: "It is apparent that gross and histopathological examinations of the adult rats were not performed by the registrant. Therefore, proper interpretation of the reproductive effects observed in the study cannot be performed." In addition, meeting minutes from a discussion between DuPont and the Agency's scientists held on July 22, 1987 (in the public docket) make it clear that in addition to the lack of histopathological data, fewer than 20 animals per group were tested which were fewer than guideline specification. Griffin LLC can only assume an error was made in reviewing the classification of the acceptable/ guideline designation or the study was re­ evaluated and given a new assessment. If there is a new review, the Agency has not notified the registrant. Regardless, a significant discrepancy exists. Agency Response 2: The HIARC (TXR No. 0050286, November 20, 2001) used the 2­ generation reproduction study in the rat was used to establish the endpoints for short­ term oral, dermal, and inhalation exposure scenarios. In the 2­ generation reproduction study, the NOAEL was established at 5.8 mg/ kg/ day, based on statistically and biologically significant increases in pre­ mating body weights in F0 and F1 animals. 4 Further, the results of the 3­ generation study, in conjunction with those of the 2­ generation study, were examined to help inform the Agency` s assessment of susceptibility. Table 2 of the HED Chapter incorrectly classified the 3­ generation reproduction study in the rat (MRID 00146071, 00155168) as acceptable/ guideline. The Registrant is correct in stating that the 3­ generation study should be classified as unacceptable/ guideline. Registrant Comment 3: The third major discrepancy is the determination of a `neurotoxicity' concern. There has never been an Agency concern for neurotoxicity induced by linuron. The Agency previously recognized this in that no acute or subchronic neurotoxicity studies were requested. Linuron has been shown to be an endocrine disruptor. This has never been in question. There is, however, a big difference between the weak anti­ androgenic activity elicited by linuron and `neuroendocrine' effects referred to by the Agency in this document. No data have been presented by the Agency either from registrant sponsored studies or from the literature which would be a basis for a neurotoxicity concern. This designation of "neuroendocrine effects" has no scientific basis and should be either deleted from the document or supported somewhere in the scientific documents. The request for a developmental neurotoxicity test is not supported by the Agency's own assessment of the science. (see discussion above as it relates to the developmental studies) Agency Response 3: Linuron causes endocrine disruption, which is a neuro­ endocrine effect. Classifying linuron as neurotoxicant is too broad and does not accurately describe the neuro­ endocrine effects– endocrine disruption­­ seen with linuron. References to linuron as a neurotoxicant will be changed to the more accurate term neuro­ endocrine or endocrine disruptor. Registrant Comment 4: The fourth major discrepancy is the reference with Linuron (and subsequent regulatory action) to linuron as an inhalation concern. There is essentially no toxicity by the inhalation route. The LD50 is >218 mg/ L or 21.8 g/ M 3 . The MOEs calculated in the Linuron RED of March 1995 were all above 100 and of no concern. These were based on the NOELs (12.1 mg/ kg) from the rat developmental study for the short­ term assessment and the 2­ generation reproduction study (1.25 mg/ kg/ day) for the intermediate term assessment. Because the occupational exposure to a pre­ emergent herbicide used once per season/ year will not exceed 30 days exposure, there is not a great inhalation risk concern driven by the use patterns. In addition, linuron is neither volatile as an active ingredient nor contains volatiles nor becomes volatile in its formulations. Given the lack of inhalation toxicity and potential for exposure, the request for a 28­ day inhalation study is not supported. This is either in error or requires scientific justification. Agency Response 4: Beyond the scope of error­ only comments and will be addressed in Phase IV. 5 Residue Chemistry Considerations: Registrant Comment 5: Page 46. Miscellaneous Commodities "Cotton, seed and gin products For the gin byproducts field trials, information describing the type of equipment used for harvesting in the machine­ harvest trials must be submitted. In addition, additional cotton gin byproducts field trials must be conducted, such that the requirements of GLN 860.1000 (Table 1) for gin byproducts field trials are fulfilled, or a justification for the substitution of data from field trials reflecting hand harvesting must be submitted." A response to the issues raised above was submitted to Mr. Tom Myers, Chemical Review Manager. The letter of transmittal is dated January 14, 2002 and was sent via FedEx on this date. Our records indicate that this response was received on January 16. Agency Response 5: The registrant states that a response to the issues raised in the chapter was submitted to Mr. Tom Myers, CRM, on January 14, 2002. This document is identified as additional information to MRID 45302201 (d280653) without an MRID. The registrant has submitted justification for hand harvesting samples of cotton gin trash and has supplied the requested information describing the machinery used in harvesting. Although the field trial data are not consistent with current guideline for geographic distribution, since the use of Linuron is limited to east of the rocky mountains the data submitted represent nearly 90% of the growing regions. The data requirement for a tolerance for cotton gin trash is satisfied and a tolerance of 10 ppm will be recommended. Registrant Comment 6: Page 47. Magnitude of the Residue in Processed Food/ Feed "The 2/ 94 RED and 2/ 95 RED Addendum concluded that additional data were required to upgrade an existing potato processing study (S. Knizner, 9/ 2/ 92); these data remain outstanding." A response to the memorandum from Steven A. Knizer to Lois Rossi was submitted to the Agency on February 14, 2000. Our records show that the response was received by the Agency on February 18, 2000. The information requested for upgrading this study was included in the submittal. Agency's Response 6: The registrant claims to have submitted a response on February 14, 2000 to the memorandum from Steven Knizer to Lois Rossi (09/ 02/ 1992) upgrading the potato processing study. The registrant has identified the response only by date. The document in question cannot be located without a MRID number. If the registrant can provide the Agency with a copy of the original February 14, 2000 document or an MRID number it will be reviewed. 6 Drinking Water Considerations Registrant Comment 7: The Agency used the IR­ PCA PRZM/ EXAM model that has never been validated and has been proven to grossly overestimate residues in drinking water. It is stated in the document that "Modeling results are higher than those from existing surface water monitoring data for linuron targeted to the pesticide use area". Percent Crop Area (PCA) was used in the modeling of linuron on carrots. PCA is only applicable to major crops and carrots in the San Joaquin –Tulare Basins is not considered a major crop. Data from the 1992 Census of Agriculture were used to generate the PCA's and recent changes in the agriculture sector has significantly impacted the distribution of crops throughout the US. We feel that the IR­ PCA PRZM/ EXAM model is not a valid modeling system for estimating residues in drinking water and that the inputs into the model are not valid. The results from this model misrepresent the actual residues that occur in drinking water. Monitoring data cited by the Agency much more accurately reflects linuron residues in drinking water. Agency Response 7: These comments are beyond the scope of error­ only comments and will be addressed in the Public Comment Phase (Phase III) of the public participation process. Registrant Comment 8: The Agency recommended that 5 ppb of linuron be used in the drinking water assessment based on monitoring data cited. It is recommended in this document that 5 ppb be used in the drinking water assessment in ground water. Data cited in the review show that the highest residue in drinking water was 5 ppb. We recommend that the Agency use in their drinking water assessment an average residue from the water monitoring data. Data cited by the Agency from a USGS NAWQA monitoring study show linuron residues were detected in only 0.11% of the 924 samples analyzed. The maximum concentration was 0.029 ppb. In another study cited, linuron residues were present in 29% of the 377 analyses. The highest residue from this monitoring study was 5 ppb. Again, the Agency is using a value that grossly overestimates linuron residues in drinking water. If an average residue value is used, then the estimated exposure would be <1 ppb. Additional monitoring data can be found at the following website: http:// water. wr. usgs. gov/ pnsp/ pestgw/ In this monitoring program, water samples were collected from 1243 wells and 1849 aquifers located in agricultural areas. Linuron residues were detected in 0.16% of the wells and 0.05% of the aquifers. The maximum linuron residue detected in these water samples was 0.03 ppb. Water samples were also collected from 643 wells in urban areas and no residues were detected in any of the water samples analyzed. Agency Response 8: These comments are beyond the scope of error­ only comments and 7 will be addressed in the Public Comment Phase (Phase III) of the public participation process.

epa

2024-06-07T20:31:41.935491

regulations

EPA-HQ-OPP-2002-0079-0016

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES April 16, 2002 MEMORANDUM: LINURON: IR­ 4 Petitions for Use on Rhubarb (8E5027) and Celeriac (8E5028) PC Code (035506) DP Barcodes D281591 and D281599 FROM: Carol Christensen, Risk Assessor Reregistration Branch II Health Effects Division (7509C) THRU: Alan Nielsen, Branch Senior Scientist Reregistration Branch II Health Effects Division (7509C) TO: Hoyt Jamerson, IR­ 4 Petition Manager Minor Use, Inerts and Emergency Response Branch Registration Division (7505C) The attached document was generated in response to Inter­ Regional Research Project number 4 IR4 petitions for the establishment of tolerances for the use of 3­( 3,4­ dichlorophenyl)­ 1­ methoxy­ 1­ methylurea, linuron, on rhubarb (petition 8E5027) and celeriac (petition 8E5028). The aggregate exposures and risks associated with the use of linuron were assessed in the HED Chapter of the Tolerance Reassessment Eligibility Decision document dated April 15, 2002 to which this document is an addendum. Potential risks associated with the additional use of linuron on rhubarb and celeriac are represented in this addendum. The dietary exposures were assessed by John Punzi and potential occupational exposures were assessed by Shanna Recore. Aggregate risk and risk characterization were discussed by Carol Christensen. The aggregate risk from linuron (including use on rhubarb and celeriac) do not exceed the Agency's level of concern. 2 IR­ 4 Petitions: Dietary Exposure to Rhubarb and Celeriac IR­ 4 has submitted a proposal to establish a tolerance for Linuron in/ on Rhubarb (8E5027). There are no data submitted along with this proposal. The request is for field trial data to be translated from celery to rhubarb. The proposed label directions for EPA Reg. No. 18112­ 320 and EPA Reg. No. 1812­ 245 for use on rhubarb are essentially the same directions as for celery. The following use parameters are proposed: a single application of 0.75 to 1.5 lbs ai/ A (not to exceed 2.0 lbs ai/ A (per year)); application as a non­ directed broadcast or banded spray in spring or late summer to rhubarb after harvest or before regrowth of the crop; and, a pre­ harvest interval (PHI) of 30 days. The translation of data and use directions are appropriate. The dietary exposure to Linuron from the addition of rhubarb to the registered uses will not substantially increase the exposure to Linuron from the diet. HED recommends that a tolerance of 0.50 ppm be established for Linuron and metabolites convertible to 3,4­ DCA in/ on Rhubarb. IR­ 4 has also submitted a proposal to establish a tolerance for Linuron in/ on Celeriac (8E5028). There are no data submitted along with this proposal. The request is for data to be translated from carrot to celeriac. The proposed label use directions for EPA Reg. No. 18112­ 320 and EPA Reg. No. 1812­ 245 for celeriac are essentially the same directions as for carrot. The following use parameters are proposed: a single application 0.75 to 1.5 lbs ai/ A (not to exceed 2.0 lbs ai/ A (per year) and application as a non­ directed spray after celeriac is transplanted but before it is 8 inches high. A PHI is not specified. The translation of data and use directions are appropriate. The dietary exposure to Linuron from the addition of celeriac to the registered uses will not substantially increase the exposure to Linuron from the diet. HED recommends that a tolerance of 1.0 ppm be established for Linuron and metabolites convertible to 3,4­ DCA in/ on celeriac. Aggregate Risk Assessment and Risk Characterization Because there are no changes to the dietary exposure and risks associated with the use of linuron when rhubarb and celeriac are added to the list of crops on which the chemical may be used, the acute and chronic aggregate risk assessments prepared in the HED Chapter of the Tolerance Reassessment Eligibility Decision document dated April 16, 2002 are not changed. The aggregate risk from linuron (including use on rhubarb and celeriac) do not exceed the Agency's level of concern. Occupational Exposure and Risks An occupational exposure assessment was performed for the use of linuron on rhubarb and celeriac. (DP Barcode 281845, March 27, 2002) The herbicides Linex ® 50DF (dry flowable) and Linex ® 4L (liquid) which controls grasses and broadleaf weeds were included in the assessment. Linuron may be applied either by ground sprayers or chemigation to rhubarb and celeriac. A maximum of one application of 1.5 lbs active ingredient (ai)/ acre per season is proposed. 3 Based on the proposed use patterns, short­ term dermal and inhalation exposures (1­ 30 days) are expected for private applicators (farmers treating their own crops) and commercial applicators. Since no chemical­ specific data are available to assess potential exposure to workers, the exposure and risk assessment presented in this document are based on the Pesticide Handler Exposure Database Version 1.1 (PHED, Surrogate Exposure Guide, August 1998). The maximum application rate listed on the label was used for all calculations. The standard values for acreage were taken from HED Exposure Science Advisory Committee (Expo SAC) Policy # 9.1, effective September 25, 2001. All calculated Margins of Exposure (MOEs) do not exceed HED's level of concern. Workers having potential post­ application re­ entry exposure to linuron from the proposed use include scouts and workers re­ entering treated fields to perform irrigation and handweeding tasks. Since linuron will be applied at the early stages of crop growth, low potential for post­ application exposure is expected. In order to demonstrate that minimal exposure and risk are expected, a post­ application exposure assessment was done for scouting, handweeding and irrigating. The estimated MOE for these activities related to the proposed use of linuron on rhubarb and celeriac does not exceed HED's level of concern. Reference: Occupational Exposure and Risk Assessment/ Characterization for the Proposed Use of Linuron on Rhubarb and Celeriac. S. Recore, March 27, 2002 DPBarcode D281845.

epa

2024-06-07T20:31:41.939757

regulations

EPA-HQ-OPP-2002-0079-0017

Supporting & Related Material

Linuron Summary Uses ° Linuron is a substituted urea, selective herbicide registered for use on asparagus, carrots, celery, field and sweet corn, cotton, parsley, parsnips, potatoes, sorghum, soybeans, and wheat for control of a variety of weed species including annual morning glory, rye grass, and barnyard grass. In addition, three new uses are proposed for use on cotton gin by­ products, celeriac, and rhubarb. There are no registered residential uses of linuron products. ° Linuron may be applied pre­ plant, pre­ emergence, post­ emergence or post­ transplant at application rates from 0.5­ 4.0 lbs/ ai/ acre/ year and 1­ 2 applications are allowed per year. Linuron can be applied using ground equipment including band sprayer, boom sprayer, sprinkler irrigation, and tractor mounted sprayer. ° There are approximately four hundred thousand pounds of linuron active ingredient used in the U. S. annually. Health Effects C Linuron has low acute toxicity but developmental and potential neuroendocrine effects were observed in the 3­ generation reproduction rat study, the cross mating in rats study, and the leydig cell tumorigenesis in rats study. In a prenatal oral developmental rat study, linuron caused increased post­ implantation loss and fetal/ litter resorptions. In a chronic dog feeding study, blood effects were found which include reduced hemoglobin, hematocrit, and erythrocyte counts. In reproductive studies, there is evidence for testicular lesions and decreased fertility. Dietary Risks ° Based on highly refined Tier III analyses, both acute and chronic dietary risk from exposure to linuron is low (< 10% and <35% of the Population Adjusted Dose respectively) for all populations and is below the Agency's level of concern. The Agency has reassessed all 40 tolerances for linuron and can make a FQPA safety determination. Drinking Water Risks ° Based on PRZM/ EXAMS IR­ PCA (Tier II) modeling, acute drinking water Estimated Environmental Concentrations (EECs) of linuron in either ground water or surface water are less than the acute Drinking Water Level of Comparison (DWLOCs) and below the Agency's level of concern. ° Based on monitoring data from the 1992 USEPA Pesticide in Groundwater Database, the chronic drinking water EEC of linuron in ground water is less than the chronic DWLOC and below the Agency's level of concern. ° Based on PRZM/ EXAMS IR­ PCA (Tier II) modeling, the chronic drinking water EEC (18 ppb) for linuron in surface water slightly exceeds the chronic DWLOC (6 ppb). The EEC is based on upper­ end input parameters such as 87% cropped area. The EEC is most likely higher than concentrations that would actually be found in drinking water. Nonetheless, additional data are being required that will further refine the chronic drinking water risk assessment. A leaching/ adsorption/ desorption study will provide important data on the mobility of linuron and a terrestrial field dissipation study will provide information on what happens to linuron under field conditions. Aggregate Risks ° Aggregate (food + drinking water) acute risk from both surface and ground water is low and below the Agency's level of concern. ° Aggregate (food + drinking water) chronic risk from ground water is low and below the Agency's level of concern. ° Aggregate (food + drinking water) chronic risk from surface water is above the Agency's level of concern because the EEC (18 ppb) slightly exceeds the chronic DWLOC (6 ppb) for infants and children, the most sensitive population subgroups. The EEC is based on upper­ end input parameters such as 87% cropped area. The EEC is most likely higher than concentrations that would actually be found in drinking water. Nonetheless, additional data are being required that will further refine the chronic drinking water risk assessment. A leaching/ adsorption/ desorption study will provide important data on the mobility of linuron and a terrestrial field dissipation study will provide information on what happens to linuron under field conditions. Occupational and Ecological Risks ° Because linuron is under review for tolerance reassessment only, no occupational or ecological risk assessment would normally be conducted. Occupational and ecological risk management decisions were made as part of the 1995 Linuron RED and have been implemented. However, two new minor uses were established for linuron as part of the tolerance reassessment process for use on celeraic and rhubarb. A occupational risk assessment was performed for these two new uses and they do not present risks of concern for the Agency.

epa

2024-06-07T20:31:41.943100

regulations

EPA-HQ-OPP-2002-0079-0018

Supporting & Related Material

OVERVIEW OF LINURON RISK ASSESSMENT Introduction This document summarizes EPA's human health findings and conclusions for the herbicide linuron, as presented fully in the documents: HED Chapter for the Linuron Tolerance Reassessment Eligibility Decision, dated April 16, 2002, and Drinking Water Assessment for Linuron on Carrots in California, dated October 14, 2001, Drinking Water Assessment for Linuron Metabolites on Carrots in California, dated January 14, 2002, and Occupational Exposure and Risk Assessment/ Characterization for the Proposed Use of Linuron on Rhubarb and Celeriac, dated March 27, 2002. The purpose of this summary is to assist the reader by identifying the key features and findings of this risk reassessment in order to better understand the conclusions reached in the tolerance reassessment. This summary was developed in response to comments and requests from the public, which indicated that the risk assessments were difficult to understand, that they were too lengthy, and that it was not easy to compare the assessments for different chemicals due to the use of different formats. The Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act (FQPA) of 1996, requires EPA to review all the tolerances for registered chemicals in effect on or before the date of the enactment of FQPA. In reviewing these tolerances, the Agency must consider, among other things, aggregate risks from non­ occupational sources of pesticide exposure, whether there is increased susceptibility to infants and children, and the cumulative effects of pesticides with a common mechanism of toxicity. The tolerances are considered reassessed once the safety finding has been made or a revocation occurs. A Reregistration Eligibility Decision (RED) for linuron was completed in March 1995, prior to FQPA enactment; therefore, it needed to be updated to consider the provisions of the Act. FQPA stipulates that when determining the safety of a pesticide chemical, EPA shall base its assessment of the risk posed by the chemical on, among other things, available information concerning the cumulative effects to human health that may result from dietary, residential, or other nonoccupational exposure to other substances that have a common mechanism of toxicity. The reason for consideration of other substances is due to the possibility that low­ level exposures to multiple chemical substances that cause a common toxic effect by a common mechanism could lead to the same adverse health effect as would a higher level of exposure to any of the substances individually. A person exposed to a pesticide at a level that is considered safe may in fact experience harm if that person is also exposed to other substances that cause a common toxic effect by a mechanism common with that of the subject pesticide, even if the individual exposure levels to the other substances are also considered safe. EPA did not perform a cumulative risk assessment as part of the Tolerance Reassessment Decision (TRED) for linuron because the Agency has not yet initiated a comprehensive review to 2 determine if there are any other chemical substances that have a mechanism of toxicity common with that of linuron. For purposes of this risk assessment, EPA has assumed that linuron does not have a common mechanism of toxicity with other substances. Available data indicates that 3,4­ DCA is a metabolite of linuron, diuron, and propanil. EPA is not aggregating residues of 3,4­ DCA for the linuron, diuron, and propanil risk assessments because neither linuron nor diuron metabolize to 3,4– DCA in appreciable amounts (less than 1% of the parent compound) in animal, plant and environmental (soil) metabolism studies. While 3,4­ DCA is a significant residue of concern for propanil, it is not a residue of concern for linuron or diuron. In the future, the registrant may be asked to submit, upon EPA's request and according to a schedule determined by the Agency, such information as the Agency directs to be submitted in order to evaluate issues related to whether linuron shares a common mechanism of toxicity with any other substance and, if so, whether any tolerances for linuron need to be modified or revoked. The Agency has developed a framework for conducting cumulative risk assessments on substances that have a common mechanism of toxicity. This guidance was issued on January 16, 2002 (67 FR 2210­ 2214) and is available from the OPP Website at: http:// www. epa. gov/ pesticides/ trac/ science/ cumulative_ guidance. pdf. The risk assessment, and documents pertaining to the Agency's report on FQPA tolerance reassessment progress and risk management decision for linuron are available on the Internet at http:// www. epa. gov/ pesticides/ reregistration/ status. htm and in the public docket for viewing. The Agency's report on FQPA tolerance reassessment progress and risk management decision for linuron will be announced in the Federal Register. Use Profile Herbicide: Linuron is a substituted urea, selective herbicide. It is a systemic, photosynthesis inhibitor and controls a variety of weed species including annual morning glory, rye grass, and barnyard grass. Linuron is registered for use on asparagus, carrots, celery, field and sweet corn, cotton, parsnips, parsley, potatoes, sorghum, soybeans, and wheat. In addition, three new tolerances are proposed for use on cotton gin by­ products (9.0 ppm), celeriac (1.0 ppm), and rhubarb (0.5 ppm). There are no registered residential uses of linuron products. Formulations: Formulated as a wettable powder, dry flowable, flowable concentrate, water dispersible granules, (40­ 50% active ingredient for all formulations). Rates, Methods and Timing of Application: Linuron may be applied pre­ plant, pre­ emergence, post­ emergence or post­ transplant at application rates from 0.5­ 4.0 lbs/ ai/ acre/ year and 1­ 2 applications are allowed per year. Linuron is mainly used in the early season and has fairly long preharvest intervals (PHIs) (14­ 30 days), but a few crops have short PHIs, notably asparagus (1 day) and carrots (14 days). Linuron can be applied using ground equipment including band sprayer, boom sprayer, sprinkler irrigation, and tractor mounted sprayer. 3 Use Summary: On average, there are approximately four hundred thousand pounds of linuron active ingredient used in the U. S. annually. Registrant: Griffin, LLC Table 1. Major Use Sites For Linuron Crop Site Acres Grown (000) Acres Treated (000) % of Crop Treated LB AI Applied (000) States of Most Usage (% of total lbs ai used on this crop in these states) Avg Max Avg Max Avg Max Asparagus 90 18 30 20% 33% 18 36 CA WA (85%) Carrots 104 79 104 75% 100% 145 210 CA MI FL WA TX (83%) Celery 34 8 11 23% 32% 4 8 MI CA TX (84%) Cotton 12,967 88 233 1% 2% 72 123 MS AR SC NC LA TN (83%) Potatoes 1,433 100 158 7% 11% 85 180 ND MI RI ME NY MN (71%) Total For All Sites 383 577 421 788 COLUMN HEADINGS Avg = Weighted average­ the most recent years and more reliable data are weighted more heavily. Max = Estimated maximum, which is estimated from available data. Human Health Risk Assessment Acute Dietary (Food) Risk (For a complete discussion, see section 4.2.2 of the Human Health Risk Assessment) Because no effects attributed to a single exposure were identified for the general population, the 4 acute dietary exposure and risk assessment includes females 13­ 50 only. Acute dietary risk from food is calculated considering what is eaten in one day (in this instance, the full range of consumption values as well as the range of residue values in food). A risk estimate that is less than 100% of the acute Population Adjusted Dose (aPAD) (the dose at which an individual could be exposed on any given day and no adverse health effects would be expected) does not exceed the Agency's level of concern. The aPAD is the reference dose (RfD) adjusted for the FQPA Safety Factor. Table 2 presents the results of the acute dietary (food) exposure and risk analysis for females (13­ 50 years of age). Table 2. Acute Dietary (Food) Exposure and Risk (99.9th Percentile of Exposure) Population Subgroup Exposure (mg/ kg/ day) % aPAD Females (13­ 50 years) 0.003839 9.5 ° The acute dietary risk estimate does not exceed the aPAD at the 99.9th percentile estimated exposure level. The acute dietary risk estimate for females 13­ 50 years old is <10% of the aPAD. ° For the females (13­ 50 years) population subgroup, the acute No Observed Adverse Effects Level (NOAEL) of 12 mg/ kg/ day was established, based on increased post­ implantation loss and fetal/ litter resorptions in a prenatal oral developmental study in the rat. The LOAEL was 50 mg/ kg/ day. ° A traditional uncertainty factor (UF) of 100 was applied to the doses selected for the risk assessment to account for interspecies extrapolation (10x) and intraspecies variability (10x). ° For acute dietary exposure, the FQPA safety factor was reduced to 3X since: there was no susceptibility identified following in utero exposure; toxicology database is complete for FQPA assessment; the dietary exposure assessment will not underestimate the potential exposures for infants, children, and/ or women of childbearing age; and there are no residential exposures. The safety factor should be retained since the developmental neurotoxicity study in rats is required and may further define the potential neuro­ endocrine effects observed in the 3­ generation reproduction rat study, the cross mating in rats study, and the leydig cell tumorigenesis in rats study. ° The acute RfD for females 13­ 50: 12 mg/ kg/ day (NOAEL) ÷ 100 (UF) = 0.12 mg/ kg/ day. The acute PAD for females 13­ 50: 0.12 mg/ kg/ day ÷ 3 (FQPA) = 0.04 mg/ kg/ day. ° The acute dietary exposure analysis is based on the Dietary Exposure Evaluation Model (DEEM ™ ). The DEEM ™ analysis evaluated the individual food consumption as reported by respondents in the USDA 1989­ 92 Continuing Surveys for Food Intake by Individuals (CSFII). The data are based on the reported consumption of more than 10,000 individuals over three 5 days. For the acute exposure assessment, individual one­ day food consumption data are used on an individual­ by­ individual basis. ° The acute dietary (food) exposure assessment for linuron is a tier III probabilistic (Monte Carlo) analysis. Anticipated residues (ARs) were computed from field trial data and subsequently utilized to estimate the acute dietary exposure to linuron in the diets of females 13­ 50. Percent crop treated (% CT) data, residue reduction data from washing, cooking and various processing studies were used to refine the residue data. Chronic Dietary (Food) Risk (For a complete discussion, see section 4.2.3 of the Human Health Risk Assessment) Chronic dietary risk from food is calculated by using the average consumption values for food and average residue values for those foods over a 70­ year lifetime. A risk estimate that is less than 100% of the chronic PAD (cPAD) (the dose at which an individual could be exposed over the course of a lifetime and no adverse health effects would be expected) does not exceed the Agency's level of concern. Table 3 presents the results of the chronic dietary (food) exposure and risk analysis. Table 3. Chronic Dietary (Food) Exposure and Risk Population Subgroup Exposure (mg/ kg/ day) % cPAD General U. S. 0.000114 14.8 Females (13­ 50 years) 0.000083 10.8 All infants (< 1 year) 0.000179 22.3 Children (1­ 6 years) 0.000268 34.7 Children (7­ 12 years) 0.000173 22.4 ° The chronic dietary risk estimate for all population subgroups does not exceed the cPAD, all population subgroups are < 35% of the cPAD. ° For the general population, the NOAEL of 0.77 mg/ kg/ day was established, based on increased met­ and sulfhemoglobin levels in a chronic feeding study in dogs. The LOAEL was 4.17 mg/ kg/ day in males and 3.5 mg/ kg/ day in females. ° An uncertainty factor (UF) of 100 was applied to the doses selected for the risk assessment to account for interspecies extrapolation (10x) and intraspecies variability (10x). 6 ° For chronic dietary exposure, the FQPA safety factor was retained at 10X since: a qualitative increase in susceptibility was seen in the F1 males in the rat reproductive toxicity study (a longterm study); there is evidence for testicular lesions and decreased fertility in this study; and, a developmental neurotoxicity study in rats is required and may further define the potential neuroendocrine effects observed in the 3­ generation reproduction rat study, the cross mating in rats study, and the leydig cell tumorigenesis in rats study. (For a complete discussion, see LINURON­ Report of the Hazard Identification Assessment Review Committee). ° The chronic RfD: 0.77 mg/ kg/ day (NOAEL) ÷ 100 (UF) = 0.0077 mg/ kg/ day. The chronic PAD: 0.007 mg/ kg/ day ÷ 10 (FQPA) = 0.00077 mg/ kg/ day. ° The chronic dietary exposure analysis is based on the Dietary Exposure Evaluation Model (DEEM ™ ). For chronic dietary (food) assessments, a three­ day average of consumption for each population subgroup is combined with average residues in commodities to determine average exposures in mg/ kg/ day. ° The chronic dietary (food) exposure assessment for linuron is a refined tier III analysis. Anticipated residues (ARs) were computed from field trial data and subsequently utilized to estimate the chronic dietary exposure to linuron in the diets of the general U. S. population. Percent crop treated (% CT) data, residue reduction data from washing, cooking and various processing studies were used as refinements to the residue data. Drinking Water Dietary Risk (For a complete discussion, see section 4.3 of the Human Health Risk Assessment) Drinking water exposure to pesticides can occur through surface and/ or ground water contamination. EPA considers acute (one day) and chronic (lifetime) drinking water risks and uses either modeling or actual monitoring data, if available, to estimate those risks. Modeling is carried out in tiers of increasing refinement, but is designed to provide a conservative estimate of potential exposure. To determine the maximum allowable contribution from water allowed in the diet, EPA first looks at how much of the overall allowable risk is contributed by food and then determines a Drinking Water Level of Comparison" (DWLOC) to ascertain whether modeled or monitored Estimated Environmental Concentrations (EECs) exceed this level. The linuron drinking water exposure assessment is based upon review of environmental fate studies for linuron and includes both modeling and monitoring results for parent linuron, and modeling results for the degradates of linuron. Parent linuron appears to be moderately persistent and relatively immobile in the environment. The environmental fate assessment for linuron is incomplete because information on the persistence, mobility and dissipation pathways of several degradates of linuron is not available. However, none of the linuron water degradates are present at levels greater than 10% of the 7 applied parent, and therefore are not considered major water metabolites. ° The use of linuron on carrots was modeled for the purpose of assessing surface drinking water exposure to the chemical and its degradates. This use represents the greatest potential drinking water exposure because an estimated 75% of carrots are treated with linuron. ° Estimated Environmental Concentrations (EECs) for surface water were estimated using PRZM/ EXAMS (Tier II) modeling and the Index Reservoir and Percent Crop Area adjustment (IR­ PCA). The surface water monitoring data were insufficient to complete a drinking water exposure analysis so modeling was used to complete the analysis. ° EECs for ground water are based on monitoring data from the 1992 USEPA Pesticide in Groundwater Database for linuron sampled in Georgia, Missouri, Virginia, and Wisconsin. The groundwater EECs were then compared to the SCI­ GROW (Tier I) computer model for linuron and its degradates. Drinking water DWLOCs and EECs are compared in Table 4. Table 4. Drinking Water DWLOC and Acute & Chronic EEC Comparisons Population Subgroup Acute Scenario Chronic Scenario Acute DWLOC Ground Water EEC Surface Water EEC Chronic DWLOC Ground Water EEC Surface Water EEC U. S. General 23 5 18 Females (13­ 50 years) 1085 5 38 23 5 18 All infants 6 5 18 Children (1­ 6 years) 6 5 18 ° For acute drinking water risk, potential (peak) EECs of linuron in either ground water (5 ppb) or surface water (38 ppb) are below the acute DWLOC for females (13­ 50 years) (1085 ppb). ° For chronic drinking water risk from ground water, the potential (average) EEC of linuron (5 ppb) is below the chronic DWLOC (6 ppb) for infants and children, the most sensitive population subgroups. ° For chronic drinking water risk from surface water, the potential (average) EEC of linuron (18 ppb) slightly exceeds the chronic DWLOC (6 ppb) for infants and children, the most sensitive population subgroups. The chronic EEC was estimated using modeling and exceeds the DWLOC. The EEC estimate is based on upper­ end input parameters such as an assumption 8 that 87% of a watershed would be treated with linuron. EECs predicted from this model are likely higher than would be found in drinking water from surface reservoirs because it is unlikely that 87% of a watershed would be treated with linuron. Nonetheless, additional data are being required that will further refine the chronic drinking water risk assessment. A leaching/ adsorption/ desorption study will provide data on the mobility of linuron and a terrestrial field dissipation study will provide information on what happens to linuron under field conditions. Residential Risk Linuron is not registered for home use nor is it used in and around schools, or parks. Thus, there is no residential exposure to assess nor aggregate with the dietary exposure. Aggregate Risk (For a complete discussion, see section 5.0 of the Human Health Risk Assessment) Aggregate risk examines the combined risk from exposure through food, drinking water, and residential uses. Using the DWLOC approach, all risks from these exposures must be less than 100% of the aPAD or cPAD. For linuron, the aggregate risks are limited to food and water exposure, because there are no residential uses. ° Combining both the acute dietary (food) risk estimates with the surface and ground water EECs (drinking water) for linuron, the acute aggregate (food + drinking water) risk is less than 100% of the aPAD; and therefore, is not of concern to the Agency. ° Combining both the chronic dietary (food) risk estimate with the ground water EEC (drinking water) for linuron, the chronic aggregate (food + drinking water) risk is less than 100% of the cPAD, and therefore, is not of concern to the Agency. However, combining the chronic dietary (food) risk estimate with the surface water EEC (drinking water) for linuron, the chronic aggregate (food + drinking water) risk is slightly more than 100% of the cPAD. The chronic EEC was estimated using modeling and exceeds the DWLOC. The EEC estimate is based on upper­ end input parameters such as an assumption that 87% of a watershed would be treated with linuron. EECs predicted from this model are likely higher than would be found in drinking water from surface reservoirs because it is unlikely that 87% of a watershed would be treated with linuron. Nonetheless, additional data are being required that will further refine the chronic drinking water risk assessment. A leaching/ adsorption/ desorption study will provide data on the mobility of linuron and a terrestrial field dissipation study will provide information on what happens to linuron under field conditions. 9 Occupational and Ecological Risk (For a complete discussion, see section 4.2 of the Human Health Risk Assessment) Because linuron is under review for tolerance reassessment only, no occupational or ecological risk assessment would normally be conducted. Occupational and ecological risk management decisions were made as part of the 1995 Linuron RED and have been implemented. However, two new minor uses were established for linuron as part of the tolerance reassessment process for use on celeraic and rhubarb. An occupational risk assessment was performed for these two new uses and they do not present risks of concern for the Agency. Tolerance Reassessment Summary (For a complete discussion, see Linuron Tolerance Reassessment Eligibility Decision Residue Chemistry Considerations, dated 11/ 26/ 2001.) The Agency has reassessed all 40 tolerances for linuron and can make a FQPA safety determination. In addition, three new tolerances are proposed for use on cotton gin by­ products (9.0 ppm), celeriac (1.0 ppm), and rhubarb (0.5 ppm). The Agency has sufficient residue data for reassessing the tolerances for linuron and is requiring additional confirmatory data for celery, corn, sorghum, and wheat. For commodities that require additional residue data, the Current Tolerance value was used in the acute and chronic dietary risk assessments and this is the value that will continue to be used for enforcement purposes. Anticipated residues for all commodities were calculated from field trial data and subsequently utilized to estimate the dietary exposure to linuron. Acute and chronic dietary risks from exposure do not exceed the Agency's level of concern. Final tolerances are being proposed as part of this Tolerance Reassessment Decision (TRED). Additional tolerances may be revised once the confirmatory field trial data has been submitted to and reviewed by the Agency. Table 5. Tolerance Reassessment Summary for Linuron. Commodity Current Tolerance (ppm) 1 Reassessed Tolerance Level (ppm) Comment/ Correct Commodity Definition Tolerances listed under 40 CFR §180.184( a): Asparagus 7.0 7.0 Carrots 1.0 1.0 [Carrot] Cattle, fat 1.0 0.2 Cattle, mbyp 1.0 0.1 [Cattle, meat byproducts, except kidney and liver] Commodity Current Tolerance (ppm) 1 Reassessed Tolerance Level (ppm) Comment/ Correct Commodity Definition 10 Cattle, meat 1.0 0.1 Celery 0.5 0.5 / (TBD 4) The available data support use east of the Rocky Mountains; additional data are required to support use on celery west of the Rocky Mountains. Corn, field, fodder 1.0 6.0 [Corn, field, stover] Corn, field, forage 1.0 1.0 Corn, fresh (inc. sweet K+ CWHR) 0.25 0.25 / (TBD 4) Additional crop field trial data are required. [Corn, sweet (K+ CWHR)] Corn, grain (inc. popcorn) 0.25 0.1 Popcorn grain tolerance should be deleted since there are no registered uses. [Corn, field, grain] Corn, sweet, fodder 1.0 1.0 / (TBD 4) Additional crop field trial data are required. [Corn, sweet, stover] Corn, sweet, forage 1.0 1.0 / (TBD 4 ) Additional crop field trial data are required. Cottonseed 0.25 Reassign This tolerance should be reclassified under 180.184( c) because use of linuron on cotton is restricted to east of the Rocky Mountains. Goats, fat 1.0 0.2 [Goat, fat] Goats, mbyp 1.0 0.1 [Goat, meat byproducts, except kidney and liver] Goats, meat 1.0 0.1 [Goat, meat] Hogs, fat 1.0 0.05 [Hog, fat] Hogs, mbyp 1.0 0.1 [Hog, meat byproducts] Hogs, meat 1.0 0.05 [Hog, meat] Horses, fat 1.0 0.2 [Horse, fat] Commodity Current Tolerance (ppm) 1 Reassessed Tolerance Level (ppm) Comment/ Correct Commodity Definition 11 Horses, mbyp 1.0 0.1 [Horse, meat byproducts, except kidney and liver] Horses, meat 1.0 0.1 [Horse, meat] Parsnips (with tops) 0.5 0.05 [Parsnip, root] Parsnips (without tops) 0.5 0.05 [Parsnip, root] Potatoes 1.0 Reassign This tolerance should be reclassified under 180.184( c) as use of linuron on potatoes is restricted to east of the Rocky Mountains. Sheep, fat 1.0 0.2 Sheep, mbyp 1.0 0.1 [Sheep, meat byproducts, except kidney and liver] Sheep, meat 1.0 0.1 Sorghum, fodder 1.0 1.0 / (TBD 4) Additional crop field trial data are required. [Sorghum, stover] Sorghum, forage 1.0 1.0 / (TBD 4) Additional crop field trial data are required. Sorghum, grain (milo) 0.25 0.25 [Sorghum, grain] Soybeans (dry) 1.0 1.0 [Soybeans, seed] Soybeans (succulent) 1.0 1.0 [Soybean, seed] Soybean, forage 1.0 Revoke These tolerances should be revoked, provided all pertinent labels are amended to include the following feeding restriction on the product labels: "The feeding of treated forage or hay to livestock is prohibited. Commodity Current Tolerance (ppm) 1 Reassessed Tolerance Level (ppm) Comment/ Correct Commodity Definition 12 Soybean, hay 1.0 Revoke Wheat, forage 0.5 Reassign These tolerances should be reclassified under 180.184( c), as use of linuron on wheat is restricted to ID, OR, and WA. Wheat, grain 0.25 Reassign Wheat, hay 0.5 Reassign Wheat, straw 0.5 Reassign Tolerances listed under 40 CFR §180.184( c): Parsley 0.25 0.25 Tolerances established under 40 CFR §180.184( a): Cattle, kidney Not applicable 2.0 Cattle, liver Not applicable 2.0 Celeraic Not applicable 1.0 Goat, kidney Not applicable 2.0 Goat, liver Not applicable 2.0 Horse, kidney Not applicable 2.0 Horse, liver Not applicable 2.0 Milk Not applicable 0.05 Rhubarb Not applicable 0.5 Sheep, kidney Not applicable 2.0 Sheep, liver Not applicable 2.0 Tolerances established under 40 CFR §180.184( c): Cotton, gin byproducts Not applicable 9.0 Additional field trial data and/ or information is required. Cottonseed 0.25 0.05 This tolerance should be reclassified under 180.184( c) because use of linuron on cotton is restricted to east of the Rocky Mountains. [Cotton, undelinted seed] Commodity Current Tolerance (ppm) 1 Reassessed Tolerance Level (ppm) Comment/ Correct Commodity Definition 13 Potatoes 1.0 0.2 This tolerance should be reclassified under 180.184( c) because use of linuron on potatoes is restricted to east of the Rocky Mountains. [Potato] Wheat, forage 0.5 0.5 / (TBD 4) Crop field trial data are required. This tolerance should be reclassified under 180.184( c), because use of linuron on wheat is restricted to ID, OR, and WA. Wheat, grain 0.25 0.05 This tolerance should be reclassified under 180.184( c), because use of linuron on wheat is restricted to ID, OR, and WA. Wheat, hay 0.5 0.5 / (TBD 4) Crop field trial data are required. This tolerance should be reclassified under 180.184( c), because use of linuron on wheat is restricted to ID, OR, and WA. Wheat, straw 0.5 2.0 The registrants may wish to generate additional crop field trial data at 1x instead of proposing an increased tolerance. This tolerance should be reclassified under 180.184( c), because use of linuron on wheat is restricted to ID, OR, and WA. 1 Expressed in terms of linuron per se. 2 Refer to sections on Magnitude of the Residue in Crop Plants, Magnitude of the Residue in Processed Food/ Feed, and Magnitude of the Residue in Meat, Milk, Poultry, and Eggs for detailed discussion of residues in plant and animal commodities. 3 Expected residues at a 1x feeding level. 4 These commodities were included in the dietary risk assessment using the Current Tolerance level. Additional confirmatory field trial residue data are required; therefore, the final tolerance may be revised. Codex/ International Harmonization No maximum residue limits (MRLs) for linuron have been established by Codex for any agricultural commodity. In addition, no Canadian nor Mexican MRLs have been established for linuron. Therefore, no compatibility questions exist with respect to U. S. tolerances. 14 Summary of Pending Data A developmental neurotoxicity study is required and may further define the potential neuroendocrine effects observed in the 3­ generation reproduction rat study, the cross mating in rats study, and the leydig cell tumorigenesis in rats study. A 28­ day inhalation study is also required. Two environmental fate studies are required, a leaching/ adsorption/ desorption study will provide data on the mobility of linuron and a terrestrial field dissipation study will provide information on what happens to linuron under field conditions. The requirements for storage stability are not fulfilled including the final reports for ongoing storage stability studies on cotton processed commodities and sweet corn commodities. In addition, information pertaining to sample storage intervals and conditions for samples of parsnips and for the animal feeding studies are necessary. The requirements for magnitude of the residue in plants are not fulfilled for: celery, corn, sorghum, and wheat.

epa

2024-06-07T20:31:41.946378

regulations

EPA-HQ-OPP-2002-0079-0019

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES May 31, 2002 CERTIFIED MAIL Ronald Landis, Ph. D. Landis International 3185 Madison Highway PO Box 5126 Valdosta, GA 31603­ 5126 Dear Mr. Landis: This is the Environmental Protection Agency's (hereafter referred to as EPA or the Agency) "Report of the Food Quality Protection Act (FQPA) Tolerance Reassessment Progress and Risk Management Decision (TRED) for Linuron", which was approved on May 31, 2002. A Notice of Availability of this tolerance reassessment decision will be published in the Federal Register (FR) shortly. The Federal Food, Drug and Cosmetic Act (FFDCA), as amended by FQPA, requires EPA to reassess all the tolerances for registered chemicals in effect on or before the date of the enactment of the FQPA, which was in August of 1996. In reassessing these tolerances, the Agency must consider, among other things, aggregate risks from non­ occupational sources of pesticide exposure, whether there is increased susceptibility to infants and children, and the cumulative effects of pesticides with a common mechanism of toxicity. Once a safety finding has been made that aggregate risks are not of concern, the tolerances are considered reassessed. A Reregistration Eligibility Decision (RED) for linuron was completed in March, 1995, prior to FQPA enactment. Therefore, the tolerances need to be reassessed to meet the FQPA standard. The Agency has evaluated the dietary risk associated with linuron and has determined that there is a reasonable certainty that no harm to any population subgroup will result from aggregate exposure to linuron when considering dietary exposure and all other non­ occupational sources of pesticide exposure for which there is reliable information. However, for chronic drinking water risk from surface water, potential (average) Estimated Environmental Concentrations (EECs) of linuron (18 ppb) exceeds the chronic Drinking Water Level of Comparison (DWLOC) (6 ppb) for infants and children, the most sensitive population subgroups. The chronic EECs were estimated using modeling and exceed the DWLOC slightly. The EEC estimate is based on upper­ end input parameters such as an assumption that 87% of a watershed would be treated with linuron. EECs predicted from this model are likely higher than would be found in drinking water from surface reservoirs because it is unlikely that 87% of a watershed would be treated with linuron. Nonetheless, additional data are being required that will further refine the chronic drinking water risk assessment. A leaching/ adsorption/ desorption study will provide data on the mobility of linuron and a terrestrial field dissipation study will provide information on what happens 2 to linuron under field conditions. FQPA requires that EPA consider "available information" concerning the cumulative effects of a particular pesticide's residues and "other substances that have a common mechanism of toxicity." The reason for considering other substances is because of the possibility that low­ level exposures to multiple chemical substances that cause a common toxic effect by a common mechanism could lead to the same adverse health effect, as would a higher level of exposure to any of the other substances individually. EPA did not perform a cumulative risk assessment as part of this review of linuron, because the Agency has not determined that there are any other chemical substances that have a mechanism of toxicity common with that of linuron. If EPA identifies other substances that share a common mechanism of toxicity with linuron, then a cumulative risk assessment will be conducted that includes linuron once the final framework EPA will use for conducting cumulative risk assessments is available. Further, EPA is in the process of developing criteria for characterizing and testing endocrine disrupting chemicals and plans to implement an Endocrine Disruptor Screening Program. Linuron will be reevaluated at that time and additional studies may be requested. The Agency's human health findings for the pesticide linuron, were discussed in a closure conference call, and are summarized in the enclosed Linuron Overview and Linuron Summary of the risk assessments. The risk assessments and other documents pertaining to the linuron tolerance reassessment decision are available on the Internet at http:// www. epa. gov/ pesticides/ reregistration/ status. htm and are in the public docket for viewing. The Agency has reassessed all 40 tolerances for linuron and can make a FQPA safety determination. In addition, three new tolerances are proposed for use on cotton gin by­ products (9.0 ppm), celeriac (1.0 ppm), and rhubarb (0.5 ppm). The Agency has sufficient residue data for reassessing the tolerances for linuron and is requiring additional confirmatory data for celery, corn, sorghum, and wheat. Anticipated residues for all commodities were calculated from field trial data and subsequently utilized to estimate the dietary exposure to linuron. For commodities that require additional residue data, the Current Tolerance value was used in the acute and chronic dietary risk assessments and this is the value that will continue to be used for enforcement purposes until the additional confirmatory data are reviewed. Acute and chronic dietary risks from exposure do not exceed the Agency's level of concern. Final tolerances are being proposed as part of this Tolerance Reassessment Decision. Tolerances may be revised once the confirmatory field trial data have been submitted to and reviewed by the Agency. Table 1. Tolerance Reassessment Summary for Linuron. Commodity Current Tolerance (ppm) 1 Reassessed Tolerance Level (ppm) Comment/ Correct Commodity Definition Tolerances listed under 40 CFR §180.184( a): Asparagus 7.0 7.0 Carrots 1.0 1.0 [Carrot] Cattle, fat 1.0 0.2 Commodity Current Tolerance (ppm) 1 Reassessed Tolerance Level (ppm) Comment/ Correct Commodity Definition 3 Cattle, mbyp 1.0 0.1 [Cattle, meat byproducts, except kidney and liver] Cattle, meat 1.0 0.1 Celery 0.5 0.5 / (TBD 4) The available data support use east of the Rocky Mountains; additional data are required to support use on celery west of the Rocky Mountains. Corn, field, fodder 1.0 6.0 [Corn, field, stover] Corn, field, forage 1.0 1.0 Corn, fresh (inc. sweet K+ CWHR) 0.25 0.25 / (TBD 4) Additional crop field trial data are required. [Corn, sweet (K+ CWHR)] Corn, grain (inc. popcorn) 0.25 0.1 Popcorn grain tolerance should be deleted since there are no registered uses. [Corn, field, grain] Corn, sweet, fodder 1.0 1.0 / (TBD 4) Additional crop field trial data are required. [Corn, sweet, stover] Corn, sweet, forage 1.0 1.0 / (TBD 4 ) Additional crop field trial data are required. Cottonseed 0.25 Reassign This tolerance should be reclassified under 180.184( c) because use of linuron on cotton is restricted to east of the Rocky Mountains. Goats, fat 1.0 0.2 [Goat, fat] Goats, mbyp 1.0 0.1 [Goat, meat byproducts, except kidney and liver] Goats, meat 1.0 0.1 [Goat, meat] Hogs, fat 1.0 0.05 [Hog, fat] Hogs, mbyp 1.0 0.1 [Hog, meat byproducts] Hogs, meat 1.0 0.05 [Hog, meat] Horses, fat 1.0 0.2 [Horse, fat] Commodity Current Tolerance (ppm) 1 Reassessed Tolerance Level (ppm) Comment/ Correct Commodity Definition 4 Horses, mbyp 1.0 0.1 [Horse, meat byproducts, except kidney and liver] Horses, meat 1.0 0.1 [Horse, meat] Parsnips (with tops) 0.5 0.05 [Parsnip, root] Parsnips (without tops) 0.5 0.05 [Parsnip, root] Potatoes 1.0 Reassign This tolerance should be reclassified under 180.184( c) as use of linuron on potatoes is restricted to east of the Rocky Mountains. Sheep, fat 1.0 0.2 Sheep, mbyp 1.0 0.1 [Sheep, meat byproducts, except kidney and liver] Sheep, meat 1.0 0.1 Sorghum, fodder 1.0 1.0 / (TBD 4) Additional crop field trial data are required. [Sorghum, stover] Sorghum, forage 1.0 1.0 / (TBD 4) Additional crop field trial data are required. Sorghum, grain (milo) 0.25 0.25 [Sorghum, grain] Soybeans (dry) 1.0 1.0 [Soybean, seed] Soybeans (succulent) 1.0 1.0 [Soybean, seed] Soybean, forage 1.0 Revoke These tolerances should be revoked, provided all pertinent labels are amended to include the following feeding restriction on the product labels: "The feeding of treated forage or hay to livestock is prohibited. Soybean, hay 1.0 Revoke Commodity Current Tolerance (ppm) 1 Reassessed Tolerance Level (ppm) Comment/ Correct Commodity Definition 5 Wheat, forage 0.5 Reassign These tolerances should be reclassified under 180.184( c), as use of linuron on wheat is restricted to ID, OR, and WA. Wheat, grain 0.25 Reassign Wheat, hay 0.5 Reassign Wheat, straw 0.5 Reassign Tolerances listed under 40 CFR §180.184( c): Parsley 0.25 0.25 Tolerances established under 40 CFR §180.184( a): Cattle, kidney Not applicable 2.0 Cattle, liver Not applicable 2.0 Celeraic Not applicable 1.0 Goat, kidney Not applicable 2.0 Goat, liver Not applicable 2.0 Horse, kidney Not applicable 2.0 Horse, liver Not applicable 2.0 Milk Not applicable 0.05 Rhubarb Not applicable 0.5 Sheep, kidney Not applicable 2.0 Sheep, liver Not applicable 2.0 Tolerances established under 40 CFR §180.184( c): Cotton, gin byproducts Not applicable 9.0 Additional field trial data and/ or information is required. Cottonseed 0.25 0.05 This tolerance should be reclassified under 180.184( c) because use of linuron on cotton is restricted to east of the Rocky Mountains. [Cotton, undelinted seed] Potatoes 1.0 0.2 This tolerance should be reclassified under 180.184( c) because use of linuron on potatoes is restricted to east of the Rocky Mountains. [Potato] Commodity Current Tolerance (ppm) 1 Reassessed Tolerance Level (ppm) Comment/ Correct Commodity Definition 6 Wheat, forage 0.5 0.5 / (TBD 4) Crop field trial data are required. This tolerance should be reclassified under 180.184( c), because use of linuron on wheat is restricted to ID, OR, and WA. Wheat, grain 0.25 0.05 This tolerance should be reclassified under 180.184( c), because use of linuron on wheat is restricted to ID, OR, and WA. Wheat, hay 0.5 0.5 / (TBD 4) Crop field trial data are required. This tolerance should be reclassified under 180.184( c), because use of linuron on wheat is restricted to ID, OR, and WA. Wheat, straw 0.5 2.0 The registrants may wish to generate additional crop field trial data at 1x instead of proposing an increased tolerance. This tolerance should be reclassified under 180.184( c), because use of linuron on wheat is restricted to ID, OR, and WA. 1 Expressed in terms of linuron per se. 2 Refer to sections on Magnitude of the Residue in Crop Plants, Magnitude of the Residue in Processed Food/ Feed, and Magnitude of the Residue in Meat, Milk, Poultry, and Eggs for detailed discussion of residues in plant and animal commodities. 3 Expected residues at a 1x feeding level. 4 These commodities were included in the dietary risk assessment using the Current Tolerance level. Additional confirmatory field trial residue data are required; therefore, the final tolerance may be revised. No maximum residue limits (MRLs) for linuron have been established by Codex for any agricultural commodity. In addition, no Canadian nor Mexican MRLs have been established for linuron. Therefore, no compatibility questions exist with respect to U. S. tolerances. Note that you will be sent a Section 3( c)( 2)( B) Data­ Call­ In (DCI) letter under the Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) in a separate mailing. If you have questions on this document, please contact the Chemical Review Manager, Dirk V. Helder, at (703) 305­ 4610. Sincerely, Lois A. Rossi, Director Special Review and Reregistration Division 7 Enclosures: "Linuron Overview" and "Linuron Summary"

epa

2024-06-07T20:31:41.953500

regulations

EPA-HQ-OPP-2002-0079-0020

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES PC Code: 035506 DP Barcode: D275651 Date: 10/ 14/ 01 MEMORANDUM: Drinking Water Assessment for Linuron on Carrots in California. TO: Carol Christensen Reregistration actions Branch II Health Effects Division (7509C) FROM: Ibrahim Abdel­ Saheb/ Agronomist Environmental Risk Branch II Environmental Fate and Effects Division (7507C) PEER REVIEW: Jim Carleton/ Chemist Environmental Risk Branch II Environmental Fate and Effects Division (7507C) THRU: Tom Bailey, Branch Chief Environmental Risk Branch II Environmental Fate and Effects Division (7507C) Conclusions: The 3­( 3­, 4­ dichlorophenyl)­ 1­ methoxy­ 1­ methylurea (Linuron) use on carrots in Griffin Label (EPA Reg. No. 1812­ 320) is represented by this memorandum. Linuron is a herbicide used to control germinating and newly emerging grasses and broad­ leafed weeds. It is applied to agricultural crops, ornamental bulbs, and poplar trees for use in shelterbelts in the mid­ west. 2 Formulations include water dispersable granules, wettable powders, flowable concentrates, and emulsifiable concentrates/ liquid suspensions. Linuron usually is applied after a crop has been planted but before weeds emerge, using ground or aerial equipment. In some crops, such as carrots and celery, linuron is applied to newly emerging plants as an over­ top spray. In asparagus, linuron is applied between cuttings of newly emerging spears for weed control during harvest. The Tier II screening models PRZM 1 and EXAMS 2 with the Index Reservoir and Percent Crop Area adjustment (IR­ PCA PRZM/ EXAMS) were used to determine estimated surface water concentrations of linuron. The Screening Concentration in Groundwater (SCI­ GROW 3 ) model was used to estimate groundwater concentrations for linuron. Modeling results are shown in Table 1. Table 1. Estimated environmental concentrations in surface and groundwater for linuron use on carrots. model EECs (µg/ L) use( s) modeled PCA Surface water/ peak (90 th percentile annual daily max.) 31.3 two applications on carrots @ 1.0 lb ai/ acre, ground application Defaul t PCA (0.87) Surface water/ 90 t h percentile annual mean) 12.5 Surface water/ 36­ year overall mean 7.31 Groundwater/ peak and long term average 0.54 The IR­ PCA PRZM/ EXAMS modeling results indicate that linuron has the potential to contaminate surface waters by spray drift, and runoff in areas with large amounts of annual rainfall. Modeling results are higher than those from existing surface water monitoring data for linuron targeted to the pesticide use area. 3 The recommended groundwater drinking water EECs is 5.0 ppb (from the USEPA Pesticide in Groundwater Database). The modeling result is lower than historical data from the USEPA (data > 10 years old). The maximum observed concentration was 5.0 ppb. Recent NAWQA data which includes drinking water wells show no concentration > 0.029 ppb. This recommendation is based on the fact that there are no obvious changes in the use pattern presented in the June 7, 2001 Linuron SMART meeting. Usage map for linuron 4 is attached. Environmental Fate and Transport Assessment Although the environmental fate data base for parent linuron is essentially complete, two environmental fate data requirements (leaching/ adsorption/ desorption and terrestrial field dissipation studies) are not fulfilled. The environmental fate assessment for linuron is incomplete and tentative because information on the persistence, mobility and dissipation pathways of several degradates of linuron is not available. Parent linuron appears to be moderately persistent and relatively immobile. Increased mobility may occur under specific environmental conditions such as in coarse textured soils and soils with low levels of organic matter. Linuron dissipates principally by biotic processes such as microbial degradation. In surface soils with adequate organic matter, the combined processes of adsorption and microbial degradation would limit linuron's potential to migrate to ground water. Linuron could runoff to surface water bodies. In that case, it would degrade fairly rapidly to three primary metabolites (desmethoxy linuron, desmethyl linuron, norlinuron, and 3,4­ DCA, none of each is >10% of the applied radioactivity in the aerobic soil metabolism study). However, information on the persistence and mobility of these degradates is not currently available. Linuron exhibits some of the properties and characteristics of chemicals that have been detected in ground water, and linuron itself has been detected in ground water in four states (Georgia, Missouri, Virginia and Wisconsin). Linuron is moderately persistent with an aerobic soil metabolism half­ life ranging from 57 to 100 days. Because linuron is sufficiently persistent and may be mobile under certain environmental conditions, it has the potential to impact ground water quality. Linuron can be applied aerially or by ground spray and therefore could contaminate surface waters through spray drift. It has the potential to be somewhat persistent in surface 4 waters, particularly those with low microbiological activity and long hydrological residence times. Linuron degraded with a halflife of less than 3 weeks in nonsterile anaerobic silt loam and sand soil: water (1: 1) systems. It may be less persistent in water and sediment under anaerobic conditions than under aerobic conditions. Its bioconcentration potential is relatively low. Linuron is not currently regulated under the Safe Drinking Water Act, and water supply systems are not required to sample and analyze for it. No Maximum Contaminant Level (MCL) or drinking water health advisories have been established for linuron. The primary treatment processes employed by most water systems may not always be completely effective in removing linuron. As a result, the Agency does have some moderate concerns regarding potential risks of linuron to surface water source supply systems. Surface Water Monitoring The EFED has limited monitoring data on the concentrations of linuron in surface water at the present time. The USGS­ National Water Quality Assessment Program, San Joaquin ­ Tulare Basins analyzed surface water samples from a fixed site on the San Joaquin River near Vernalis, CA. Grab water samples were collected biweekly for one year (1993). Maximum linuron concentration was 0.29 ppb 5 , even though the San Joaquin Valley is a major production region for carrots in California 6 . In another study, the US Geological Survey (USGS) National Water Quality Assessment Program (NAWQA) collected 5196 surface water samples from 40 agricultural stream sites through the nation during the period from 1992­ 1998. One to two samples were collected at each site each month during periods when pesticide transport in the streams was expected to be low. At most sites, the sampling frequency was increased to 1 to 3 samples per week during periods when elevated levels of pesticides were expected in the streams. Linuron was detected in 2.70% of the samples (detection limit = 0.01 ppb) with a linuron maximum concentration of 1.4 ppb 7 . The frequency of sampling and the length of sampling period of both of the USGS studies were not sufficient to represent the temporal and spatial requirements for use in making regulatory determinations concerning drinking water. 5 Modeling Tier II surface water modeling was done using the Index Reservoir (IR) and Percent Crop Area (PCA) modifications to PRZM and EXAMS. The index reservoir represents a potentially vulnerable drinking water source based on the geometry of an actual reservoir and its watershed in a specific area (Illinois), using regional screening specific cropping patterns, weather, soils, and other factors. The PCA is a generic watershed­ based adjustment factor which represent the portion of a watershed planted to a crop or crops and will be applied to pesticide concentrations estimated for the surface water component of the drinking water exposure assessment using PRZM/ EXAMS with the index reservoir scenario. The IR­ PCA PRZM/ EXAMS model use and fate input parameters for linuron in surface water are shown in Table 2. The IR­ PCA PRZM/ EXAMS model input and output files for linuron are shown in Appendix I. Table 2: IR­ PC PRZM/ EXAMS input parameters for linuron use on carrots in California. Input variable Input value & calculations Source/ Quality of data Crop name carrots label EPA Reg. No. 1812­ 320). application rate (lb ai/ acre) 2 label EPA Reg. No. 1812­ 320). Interval between appl. (d) 14 label EPA Reg. No. 1812­ 320). Application efficiency 0.99 IR­ PCA Guidance 8 Spray drift fraction 0.064 IR­ PCA Guidance Application method ground label (EPA Reg. No. 1812­ 362). DWRATE (day ­1 ) 0.005 MRID# 41625401; Input parameters guidance 9 ; single value X 3. DSRATE (day ­1 ) 0.005 MRID# 41625401; Input parameters guidance; single value X 3 Kd (mL/ g) 2.7 (sandy loam) MRID# 00148443; Input parameters guidance. Soil­ Kd for best match of soil in model was used. Henry (atm. m 3 /mole) 6.07X10 ­8 (calculated) RED, 1994. 6 KBACW (h ­1 ) 0.0003 No aerobic aquatic data is available, the aerobic soil met. degradation rate was multiplied by 0 .5. MRID# 41625401. Input parameters guidance. KBACS (h ­1 ) 0.0002 Anaerobic aquatic half­ life (21 days) was multiplied by 3. MRID# 40142501. Input parameters guidance . KDP (h ­1 ) 0.0006 MRID# 40103601; Input parameters guidance. KBH, KNH, KAH (h ­1 ) (stable) MRID# 40916201; Input parameters guidance. KPS (mL/ g) 2.7 MRID# 00148443; Input parameters guidance. MWT (g/ mole) 249.1 RED, 1994. Solubility @ 25 0 C (ppm) 81 RED, 1994. Vapor pressure (torr) 1.5X10 ­5 The MERCK Index 10 . Assumptions and Uncertainties 11,12 Index Reservoir The results from the index reservoir represent potential drinking water exposure from a specific area (Illinois) with specific cropping patterns, weather, soils, and other factors. Use of the index reservoir for areas with different climates, crops, pesticides used, sources of water (e. g. rivers instead of reservoirs, etc), and hydrogeology creates uncertainties. In general, because the index reservoir represents a fairly vulnerable watershed, the exposure estimated with the index reservoir will likely be higher than the actual exposure for most drinking water sources. However, the index reservoir is not a worst case scenario, communities that derive their drinking water from smaller bodies of water with minimal outflow, or with more runoff prone soils would likely get higher drinking water exposure than estimated using the index reservoir. Areas with a more humid climate that use a similar reservoir and cropping patterns may also get more pesticides in their drinking water than predicted using this scenario. A single steady flow has been used to represent the flow through the reservoir. Discharge from the reservoir also removes chemical so this assumption will underestimate removal from the reservoir during wet periods and overestimates removal during dry periods. This assumption can underestimate or overestimate the concentration in the pond depending upon the annual precipitation pattern at the site. 7 The index reservoir scenario uses the characteristics of a single soil to represent the soil in the basin. In fact, soils can vary substantially across even small areas, and this variation is not reflected in these simulations. The index reservoir scenario does not consider tile drainage. Areas that are prone to substantial runoff are often tile drained. Tile drainage contributes additional water and in some cases, additional pesticide loading to the reservoir. This may cause either an increase or decrease in the pesticide concentration in the reservoir. Tile drainage also causes the surface soil to dry out faster. This will reduce runoff of the pesticide into the reservoir. The watershed used as the model for the index reservoir (Shipman City Lake) does not have tile drainage in the cropped areas. EXAMS is unable to easily model spring and fall turnover. Turnover occurs when the temperature drops in the fall and the thermal stratification of the reservoir is removed. Turnover occurs again in the spring when the reservoir warms up. This results in complete mixing of the chemical through the water column at these times. Because of this inability, the Index Reservoir has been simulated without stratification. There is data to suggest that Shipman City Lake, upon which the Index Reservoir is based, does indeed stratify in the deepest parts of the lake at least in some years. This may result in over or underestimation of the concentration in drinking water depending upon the time of the year and the depth the drinking water intake is drawing from. Percent Crop Area Correction Factor The PCA is a watershed­ based modification. Implicit in its application is the assumption that currently­ used field­ scale models reflect basin­ scale processes consistently for all pesticides and uses. In other words, we assume that the field scale processes simulated by the coupled PRZM and EXAMS models are a reasonable approximation of pesticide fate and transport within a watershed that contains a drinking water reservoir. If the models fail to capture pertinent basin­ scale fate and transport processes consistently for all pesticides and all uses, the application of a factor that reduces the estimated concentrations predicted by modeling could, in some instances, result in inadvertently passing a chemical through the screen that may actually pose a risk. Some preliminary assessments made in the development of the PCA suggest that PRZM/ EXAMS may not be realistically capturing basin­ scale processes for all pesticides or for all uses. A preliminary survey of water assessments which 8 compared screening model estimates to readily available monitoring data suggest uneven model results. In some instances, the screening model estimates are more than an order of magnitude greater than the highest concentrations reported in available monitoring data; in other instances, the model estimates are less than monitoring concentrations. Because of these concerns, the SAP recommended using the PCA only for "major" crops in the Midwest. For other crops, development of PCA's will depend on the availability of relevant monitoring data that could be used to evaluate the result of the PCA adjustment. The spatial data used for the PCA came from readily­ available sources and have a number of inherent limitations: ° The size of the 8­ digit HUC [mean = 366,989 ha; range = 6. 7­ 2,282,081 ha; n = 2,111] may not provide reasonable estimates of actual PCA's for smaller watersheds. The watersheds that drain into drinking water reservoirs are generally smaller than the 8­ digit HUC and may be better represented by watersheds defined for drinking water intakes. ° The conversion of the county level data to watershed­ based percent crop areas assumes the distribution of the crops within a county is uniform and homogeneous throughout the county area. Distance between the treated fields and the water body is not addressed. ° The PCA's were generated using data from the 1992 Census of Agriculture. However, recent changes in the agriculture sector from farm bill legislation may significantly impact the distribution of crops throughout the country. The methods described in this report can rapidly be updated as more current agricultural crops data are obtained. The assumption that yearly changes in cropping patterns will cause minimal impact needs to be evaluated. The PCA adjustment is only applicable to pesticides applied to agricultural crops. Contributions to surface waters from nonagricultural uses such as urban environments are not wellmodeled Currently, non­ agricultural uses are not included in the screening model assessments for drinking water. The PCA does not consider percent crop treated because detailed pesticide usage data are extremely limited at this time. Detailed pesticide usage data are currently available for only a few states. 9 Groundwater Monitoring EFED has limited monitoring data on the concentrations of Linuron in groundwater. Table 3 shows validated monitoring data for linuron that are available for the states of Georgia (GA), Missouri (MO), Virginia (VA), and Wisconsin (WI). Table 3. Groundwater monitoring data for linuron. Number of wells sampled (number of wells with residues) 13 . State well results range of conc. (ppb) GA 70 (67) 1.0 ­ 5.0 Mo 269 (38) 0.2 ­ 1.9 VA 12 (5) 0.042 ­ 3.79 WI 26 (1) 3.00 In addition, the US Geological Survey (USGS) National Water Quality Assessment Program (NAWQA) analyzed pesticide occurrence and concentrations in shallow ground water in agricultural areas (detection limit = 0.01 ppb). Analysis of 924 samples showed linuron in 0.11% of the samples analyzed with a maximum concentration of 0.029 ppb 14 . A Major component of the sampling design in the NAWQA study was to target specific watersheds and shallow ground water areas that are influenced primarily by a single dominant land use( agricultural or urban) that is important in the particular area. The ground­ water data were primarily collected from a combination of production and monitoring wells. Ground­ water sites in the NAWQA study were sampled for pesticides once at each site. Even though the groundwater monitoring data collected by USGS NAWQA are from sites considered to represent typical use areas, the frequency and duration of sampling were not sufficient to represent an adequate monitoring data set for exclusive use in drinking water exposure determination. The SCI­ GROW model was used to estimate potential groundwater concentrations of linuron. 10 Table 4 shows the input parameter values used in SCI­ GROW modeling. Table 4. Input parameters for linuron used in the SCI­ GROW model. Input variable Input value & calculation s Source/ Quality of data 1 Application rate (lb ai/ acre) 1.0 (EPA Reg. No. 1812­ 320). Maximum No. of Applications 2 (EPA Reg. No. 1812­ 320). Koc (mL/ g) 208 MRID# 46007015 (median value); Input parameters guidance. Aerobic Soil metabolism t1/ 2. (day) 49 MRID# 41625401; Input parameters guidance. Groundwater EECs predicted using the SCI­ GROW screening model are substantially less than those estimated for surface water using PRZM and EXAMS. SCI­ GROW estimated concentrations of linuron are also much less than those from monitoring data shown in Table 3. Therefore, for drinking water concentrations from groundwater sources we recommend 5.0 ppb to be used in the drinking water assessment. REFERENCES 1. Carsel, R. F., J. C. Imhoff, P. R. Hummel, J. M. Cheplick and J. S. Donigian, Jr. 1997. PRZM­ 3, A Model for Predicting Pesticide and Nitrogen Fate in Crop Root and Unsaturated Soil Zones: Users Manual for Release 3.0; Environmental Research Laboratory, Office of Research and Development, U. S. Environmental Protection Agency, Athens, GA. 2. Burns, L. A. March 1997. Exposure Analysis Modeling System (EXAMSII) Users Guide for Version 2.97.5, Environmental Research Laboratory, Office of Research and Development, U. S. Environmental Protection Agency, Athens, GA. 3. Barrett, M., 1997, Proposal For a Method to Determine Screening Concentration Estimates for Drinking Water Derived from Groundwater Studies, EFED/ OPP. 11 4. U. S GS. 1992. National Water Quality Assessment (NWQA), Pesticides National Synthesis Project, Annual Use: Linuron. 5. U. S GS. 1993. National Water Quality Assessment Program San Joaquin ­ Tulare Basins Study Unit, [Online]. Available at http:// ca. water. usgs. gov/ sanj_ nawqa/ data_ sw/ ifs. 1993. herb2. 6. The United State Department of Agriculture, Office of Pesticide Management Policy & Pesticide Impact Assessment Program. Crop Profile for Carrots in California, [Online]. A v a i l a b l e a t http:// pestdata. ncsu. edu/ cropprofiles/ Detail. CFM? FactShee ts_ RecordID= 285. 7. USGS. 1998. Pesticides in Surface and Ground Water of the United States: Summary of Results of the National Water Quality Assessment Program, [Online]. Available at http://( NAWQA)= http:// ca. water. usgs. gov/ pnsp/ allsum/# t1. 8. Effland, W., N. Thurman, I. Kennedy, R. D. Jones, J. Breithaupt, J. Lin, J. Carleton, L. Libel. R. Parker, and R. Matzner. 2000. " Guidance for use of the index Reservoir and Percent Crop Area Factor in drinking water exposure assessment s. Office of Pesticide Programs. 9. Guidance for Chemistry and Management Practice Input Parameters For Use in Modeling the Environmental Fate and Transport of Pesticides. Version 2. November 7, 2000. U. S. EPA Office of Pesticide Programs, Environmental Fate and Effects Division. 10. The Merck Index. 1989. An encyclopedia of chemicals, drugs, and biologicals. 11 th ed. Rahway, N. J. p. 533. 11. Carsel, R. F., J. C. Imhoff, P. R. Hummel, J. M. Cheplick and J. S. Donigian, Jr. 1997. PRZM­ 3, A Model for Predicting Pesticide and Nitrogen Fate in Crop Root and Unsaturated Soil Zones: Users Manual for Release 3.0; Environmental Research Laboratory, Office of Research and Development, U. S. Environmental Protection Agency, Athens, GA. 12. U. S. Environmental Protection Agency. 1984. Chemical Information Fact Sheet Number 28: Linuron. Office of Pesticides and Toxic Substances, Washington, DC, 9­ 13. 13. U. S. EPA. 1992. Pesticides in Ground Water Database­ A compilation of Monitoring Studies: 1971 ­ 1991. Office of 12 Prevention, Pesticides, and Toxic Substances, EPA 734­ 12­ 92­ 001. 14. U. S GS. 1998. National Water Quality Assessment (NWQA), Pesticides National Synthesis Project [Online] at http:// ca. water. usgs. gov/ pnsp/ allsum/# over. APPENDIX I IR­ PCA PRZM/ EXAMS INPUT FILE FOR THE USE OF LINURON ON CARROTS IN CALIFORNIA LINURON Lerdo clay loam, MLRA C­ 17; Central Valley, CA, Carrots 0.700 0.500 0 17.00 1 1 4 0.21 1.00 1.000 172.8 3 1.00 600.00 1 1 0.20 60.00 80.00 3 91 85 88 0.00 100.00 1 3 0101 21 9 2209 0.10 0.10 0.10 .023 .023 .023 36 100948 231248 311248 1 100949 231249 311249 1 100950 231250 311250 1 100951 231251 311251 1 100952 231252 311252 1 100953 231253 311253 1 100954 231254 311254 1 100955 231255 311255 1 100956 231256 311256 1 100957 231257 311257 1 100958 231258 311258 1 100959 231259 311259 1 100960 231260 311260 1 100961 231261 311261 1 100962 231262 311262 1 100963 231263 311263 1 100964 231264 311264 1 100965 231265 311265 1 100966 231266 311266 1 100967 231267 311267 1 13 100968 231268 311268 1 100969 231269 311269 1 100970 231270 311270 1 100971 231271 311271 1 100972 231272 311272 1 100973 231273 311273 1 100974 231274 311274 1 100975 231275 311275 1 100976 231276 311276 1 100977 231277 311277 1 100978 231278 311278 1 100979 231279 311279 1 100980 231280 311280 1 100981 231281 311281 1 100982 231282 311282 1 100983 231283 311283 1 2 non­ incorporated applications of 2.0 lbs A. I./ acre (2.24 Kg/ Ha), spry drift 0.99, APPEFF. 0.064 72 1 0 Linuron *** Kd: 2.7 AeSM: T1/ 2= 49 days AnAQ Met: T1/ 2= 21 days *** 101248 0 2 0.00 2.24 0.99 0.064 241248 0 2 0.00 2.24 0.99 0.064 101249 0 2 0.00 2.24 0.99 0.064 241249 0 2 0.00 2.24 0.99 0.064 101250 0 2 0.00 2.24 0.99 0.064 241250 0 2 0.00 2.24 0.99 0.064 101251 0 2 0.00 2.24 0.99 0.064 241251 0 2 0.00 2.24 0.99 0.064 101252 0 2 0.00 2.24 0.99 0.064 241252 0 2 0.00 2.24 0.99 0.064 101253 0 2 0.00 2.24 0.99 0.064 241253 0 2 0.00 2.24 0.99 0.064 101254 0 2 0.00 2.24 0.99 0.064 241254 0 2 0.00 2.24 0.99 0.064 101255 0 2 0.00 2.24 0.99 0.064 241255 0 2 0.00 2.24 0.99 0.064 101256 0 2 0.00 2.24 0.99 0.064 241256 0 2 0.00 2.24 0.99 0.064 101257 0 2 0.00 2.24 0.99 0.064 241257 0 2 0.00 2.24 0.99 0.064 101258 0 2 0.00 2.24 0.99 0.064 241258 0 2 0.00 2.24 0.99 0.064 101259 0 2 0.00 2.24 0.99 0.064 241259 0 2 0.00 2.24 0.99 0.064 101260 0 2 0.00 2.24 0.99 0.064 241260 0 2 0.00 2.24 0.99 0.064 101261 0 2 0.00 2.24 0.99 0.064 241261 0 2 0.00 2.24 0.99 0.064 101262 0 2 0.00 2.24 0.99 0.064 241262 0 2 0.00 2.24 0.99 0.064 101263 0 2 0.00 2.24 0.99 0.064 241263 0 2 0.00 2.24 0.99 0.064 14 101264 0 2 0.00 2.24 0.99 0.064 241264 0 2 0.00 2.24 0.99 0.064 101265 0 2 0.00 2.24 0.99 0.064 241265 0 2 0.00 2.24 0.99 0.064 101266 0 2 0.00 2.24 0.99 0.064 241266 0 2 0.00 2.24 0.99 0.064 101267 0 2 0.00 2.24 0.99 0.064 241267 0 2 0.00 2.24 0.99 0.064 101268 0 2 0.00 2.24 0.99 0.064 241268 0 2 0.00 2.24 0.99 0.064 101269 0 2 0.00 2.24 0.99 0.064 241269 0 2 0.00 2.24 0.99 0.064 101270 0 2 0.00 2.24 0.99 0.064 241270 0 2 0.00 2.24 0.99 0.064 101271 0 2 0.00 2.24 0.99 0.064 241271 0 2 0.00 2.24 0.99 0.064 101272 0 2 0.00 2.24 0.99 0.064 241272 0 2 0.00 2.24 0.99 0.064 101273 0 2 0.00 2.24 0.99 0.064 241273 0 2 0.00 2.24 0.99 0.064 101274 0 2 0.00 2.24 0.99 0.064 241274 0 2 0.00 2.24 0.99 0.064 101275 0 2 0.00 2.24 0.99 0.064 241275 0 2 0.00 2.24 0.99 0.064 101276 0 2 0.00 2.24 0.99 0.064 241276 0 2 0.00 2.24 0.99 0.064 101277 0 2 0.00 2.24 0.99 0.064 241277 0 2 0.00 2.24 0.99 0.064 101278 0 2 0.00 2.24 0.99 0.064 241278 0 2 0.00 2.24 0.99 0.064 101279 0 2 0.00 2.24 0.99 0.064 241279 0 2 0.00 2.24 0.99 0.064 101280 0 2 0.00 2.24 0.99 0.064 241280 0 2 0.00 2.24 0.99 0.064 101281 0 2 0.00 2.24 0.99 0.064 241281 0 2 0.00 2.24 0.99 0.064 101282 0 2 0.00 2.24 0.99 0.064 241282 0 2 0.00 2.24 0.99 0.064 101283 0 2 0.00 2.24 0.99 0.064 241283 0 2 0.00 2.24 0.99 0.064 0. 1 0.0 0.00 0.072 0.5 Lerdo clay loam; Hydrologic Group C 100.00 0 0 0 0 0 0 0 0 0 0.0 0.000 0.00 2 1 18.00 1.600 0.325 0.000 0.000 0.000 0.005 0.005 0.000 1.00 0.325 0.175 0.017 2.700 2 82.00 1.500 0.249 0.000 0.000 0.000 0.005 0.005 0.000 1.0 0.249 0.129 0.002 2.700 0 WATR YEAR 10 PEST YEAR 10 CONC YEAR 10 1 6 15 11 ­­­­ 5 DAY RUNF TSER 0 0 1. E0 EFLX TSER 0 0 1. E0 ESLS TSER 0 0 1. E0 RUNF TSER 0 0 1. E0 PRCP TSER 0 0 1. E0 16 IR­ PCA PRZM/ EXAMS OUTPUT FILE FOR THE USE OF LINURON ON CARROTS IN CALIFORNIA WATER COLUMN DISSOLVED CONCENTRATION (PPB) YEAR PEAK 96 HOUR 21 DAY 60 DAY 90 DAY YEARLY ­­­­ ­­­­ ­­­­­­­ ­­­­­­ ­­­­­­ ­­­­­­ ­­­­­ 1948 9.435 9.325 6.422 2.329 1.553 0.404 1949 9.955 9.840 8.497 7.644 7.053 3.680 1950 11.890 11.760 11.330 10.280 9.819 5.169 1951 10.600 10.480 9.986 9.396 8.974 4.647 1952 21.000 20.770 19.830 18.430 17.710 9.137 1953 12.020 11.890 11.640 10.740 9.992 5.283 1954 27.190 26.890 25.790 23.460 21.690 10.420 1955 15.580 15.410 14.710 13.740 12.790 6.510 1956 11.290 11.160 9.362 8.490 7.831 4.669 1957 12.600 12.460 11.880 10.920 10.360 5.678 1958 13.920 13.710 13.000 11.700 10.870 6.840 1959 10.270 10.160 9.697 8.797 8.148 4.086 1960 16.510 16.330 15.640 14.390 13.280 6.984 1961 11.670 11.550 11.020 9.910 9.124 4.476 1962 37.470 37.030 35.920 32.460 29.850 14.070 1963 28.360 28.030 26.690 24.540 22.870 11.350 1964 11.050 10.930 10.430 9.383 8.641 4.259 1965 24.260 20.610 10.820 10.240 9.405 5.963 1966 29.150 28.820 27.450 24.760 23.860 11.930 1967 17.300 17.110 16.320 14.610 13.830 7.722 1968 10.360 10.240 9.774 8.791 8.478 4.829 1969 12.320 12.180 11.610 10.550 10.350 5.865 1970 14.000 13.840 13.180 11.760 10.730 5.920 1971 10.990 10.870 10.400 9.372 8.630 5.431 1972 11.240 11.110 9.625 8.657 7.971 5.639 1973 25.240 24.960 23.810 21.460 20.490 10.300 1974 17.600 17.380 16.470 14.490 13.000 7.568 1975 15.110 14.940 14.230 12.690 11.890 6.320 1976 12.340 12.200 11.650 10.480 10.000 5.397 1977 22.180 21.930 11.240 9.721 9.147 6.433 1978 73.250 72.400 68.960 61.770 56.310 26.430 1979 16.730 16.550 15.790 14.530 13.770 6.910 1980 15.100 14.940 14.580 14.130 13.460 7.027 1981 13.080 12.930 12.390 11.380 11.000 6.157 1982 11.170 11.000 10.320 9.676 9.229 5.630 1983 36.360 35.960 34.270 31.170 28.770 13.920 17 SORTED FOR PLOTTING ­­­­­­ ­­­ ­­­­­­­ PROB PEAK 96 HOUR 21 DAY 60 DAY 90 DAY EARLY ­­­­ ­­­­ ­­­­­­­ ­­­­­­ ­­­­­­ ­­­­­­ ­­­­ 0.027 73.250 72.400 68.960 61.770 56.310 26.430 0.054 37.470 37.030 35.920 32.460 29.850 14.070 0.081 36.360 35.960 34.270 31.170 28.770 13.920 0.108 29.150 28.820 27.450 24.760 23.860 11.930 0.135 28.360 28.030 26.690 24.540 22.870 11.350 0.162 27.190 26.890 25.790 23.460 21.690 10.420 0.189 25.240 24.960 23.810 21.460 20.490 10.300 0.216 24.260 21.930 19.830 18.430 17.710 9.137 0.243 22.180 20.770 16.470 14.610 13.830 7.722 0.270 21.000 20.610 16.320 14.530 13.770 7.568 0.297 17.600 17.380 15.790 14.490 13.460 7.027 0.324 17.300 17.110 15.640 14.390 13.280 6.984 0.351 16.730 16.550 14.710 14.130 13.000 6.910 0.378 16.510 16.330 14.580 13.740 12.790 6.840 0.405 15.580 15.410 14.230 12.690 11.890 6.510 0.432 15.110 14.940 13.180 11.760 11.000 6.433 0.459 15.100 14.940 13.000 11.700 10.870 6.320 0.486 14.000 13.840 12.390 11.380 10.730 6.157 0.514 13.920 13.710 11.880 10.920 10.360 5.963 0.541 13.080 12.930 11.650 10.740 10.350 5.920 0.568 12.600 12.460 11.640 10.550 10.000 5.865 0.595 12.340 12.200 11.610 10.480 9.992 5.678 0.622 12.320 12.180 11.330 10.280 9.819 5.639 0.649 12.020 11.890 11.240 10.240 9.405 5.630 0.676 11.890 11.760 11.020 9.910 9.229 5.431 0.703 11.670 11.550 10.820 9.721 9.147 5.397 0.730 11.290 11.160 10.430 9.676 9.124 5.283 0.757 11.240 11.110 10.400 9.396 8.974 5.169 0.784 11.170 11.000 10.320 9.383 8.641 4.829 0.811 11.050 10.930 9.986 9.372 8.630 4.669 0.838 10.990 10.870 9.774 8.797 8.478 4.647 0.865 10.600 10.480 9.697 8.791 8.148 4.476 0.892 10.360 10.240 9.625 8.657 7.971 4.259 0.919 10.270 10.160 9.362 8.490 7.831 4.086 0.946 9.955 9.840 8.497 7.644 7.053 3.680 0.973 9.435 9.325 6.422 2.329 1.553 0.404 1/ 10 31.313 30.962 29.496 26.683 25.333 12.527 MEAN OF ANNUAL VALUES = 7.307 STANDARD DEVIATION OF ANNUAL VALUES = 4.336 UPPER 90% CONFIDENCE LIMIT ON MEAN = 8.377 18 SCI­ GROW output file RUN No. 1 FOR linuron INPUT VALUES ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ­­ APPL (#/ AC) APPL. URATE SOIL SOIL AEROBIC RATE NO. (#/ AC/ YR) KOC METABOLISM (DAYS) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ­­­ 1.000 2 2.000 208.0 49.0 GROUND­ WATER SCREENING CONCENTRATIONS IN PPB ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ .544 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ A= 44.000 B= 207.000 C= 1.643 D= 2.316 RILP= 2.768 F= ­. 553 G= .280 URATE= 2.000 GWSC= .560119

epa

2024-06-07T20:31:41.956482

regulations

EPA-HQ-OPP-2002-0082-0001

Rule

Triflusulfuron Methyl; Pesticide Tolerance

40189 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Rules and Regulations List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 20, 2002. Marcia E. Mulkey, Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180 [ AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U. S. C. 321( q), 346( a) and 371. 2. Section 180.[ 380] is amended by removing from the table in paragraph ( a) the entries for `` cucumbres'', `` peppers ( bell)'', `` stonefruits, except plums/ fresh prunes'' and `` strawberries'', and by adding paragraph ( e) to read as follows: § 180.380 Vinclozolin; tolerances for residues. * * * * * ( e) Revoked tolerances subject to the channel of trade provisions. The following table lists commodities with residues of vinclozolin resulting from lawful use are subject to the channels of trade provisions of section 408( l)( 5) of the FFDCA: Commodity Parts per million Cucumbers 1.0 Peppers ( bell) 3.0 Stonefruits, except plums/ fresh prunes 25.0 Strawberries 10.0 [ FR Doc. 02 13520 Filed 6 11 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP 2002 0082; FRL 7180 8] Triflusulfuron Methyl; Pesticide Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of triflusulfuron methyl in or on beet, sugar, roots; beet, sugar, tops; and chicory, roots. Interregional Research Project # 4 ( IR­ 4) and E. I. Dupont de Nemours & Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act of 1996 ( FQPA). DATES: This regulation is effective June 12, 2002. Objections and requests for hearings, identified by docket ID number OPP 2002 0082, must be received on or before August 12, 2002. ADDRESSES: Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket ID number OPP 2002 0082 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: James A. Tompkins or Hoyt Jamerson, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 305 5697 or ( 703) 308 9368; e­ mail address: tompkins. jim@ epa. gov or jamerson. hoyt@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: TABLE 1. EXAMPLES OF POTENTIALLY AFFECTED ENTITIES Categories NAICS codes Examples of potentially affected entities Industry 111 112 311 32532 Crop production Animal production Food manufacturing Pesticide manufacturing This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the persons listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations,'' `` Regulations and Proposed Rules,'' and then look up the entry for this document under the `` Federal Register Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http:// www. epa. gov/ opptsfrs/ home/ guidelin. htm. 2. In person. The Agency has established an official record for this action under docket ID number OPP 2002 0082. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805. II. Background and Statutory Findings In the Federal Register of December 22, 1999 ( 64 FR 71760) ( FRL 6391 1) and August 8, 2001 ( 66 FR 41593) ( FRL 6795 4), EPA issued a notice pursuant to section 408 of FFDCA, 21 U. S. C. 346a, as amended by FQPA ( Public Law 104 170), announcing the filing of a pesticide petition ( PP) by IR­ 4 and E. I. Dupont de Nemours & Company, 681 US Highway # 1 South North Brunswick, NJ 08902 3390, and E. I. DuPont de VerDate May< 23> 2002 00: 52 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 12JNR1. SGM pfrm17 PsN: 12JNR1 40190 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Rules and Regulations Nemours & Company, DuPont Agricultural Products, Barley Mill Plaza, Wilmington, DE 19880 0038. This notice included a summary of the petition prepared by E. I. DuPont de Nemours, the registrant. There were no comments received in response to the notice of filing. The petition requested that 40 CFR 180.492 be amended by establishing a tolerance for residues of the herbicide, triflusulfuron methyl, methyl 2­[[[[[ 4­ ( dimethylamino)­ 6­( 2,2,2­ trifluoroethoxy)­ 1,3,5­ triazin­ 2­ yl] amino] carbonyl] amino] sulfonyl]­ 3­ methylbenzoate, in or on chicory, root at 0.05 parts per million ( ppm) ( PP 0E6214). PP 4F4278 proposed that the currently established time­ limited tolerances for sugar beet, root at 0.05 ppm and sugar beet, top at 0.05 ppm be converted to permanent tolerances and to revise the commodities to read beet, sugar, roots at 0.05 ppm and beet, sugar, tops at 0.05 ppm. Section 408( b)( 2)( A)( i) of FFDCA allows EPA to establish a tolerance ( the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is `` safe.'' Section 408( b)( 2)( A)( ii) of FFDCA defines `` safe'' to mean that `` there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408( b)( 2)( C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to `` ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....'' EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances ( 62 FR 62961, November 26, 1997) ( FRL 5754 7). III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408( b)( 2)( D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408( b)( 2) of FFDCA, for tolerances for residues of triflusulfuron methyl on chicory, root at 0.05 ppm; and to convert the timelimited tolerances for beet, sugar, root at 0.05 ppm and beet, sugar, top at 0.05 to permanent tolerances. EPA's assessment of exposures and risks associated with establishing the tolerances follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by triflusulfuron methyl are discussed in Table 2 of this unit, as well as the no­ observed­ adverseeffect level ( NOAEL) and the lowestobserved adverse­ effect­ level ( LOAEL) from the toxicity studies reviewed. TABLE 2. SUBCHRONIC, CHRONIC, AND OTHER TOXICITY Guideline No. Study type Results 870.3100 90 Day oral toxicity rodents ( two studies submitted) NOAEL = 6.56/ 7.71 ( m/ f) mg/ kg/ day ( milligram/ kilogram/ day) LOAEL = 133/ 153 ( m/ f) mg/ kg/ day based on decreased body weight gain and food efficiency in males; increased incidence of histopathological changes ( kidney and spleen) in females. NOAEL = 6.20/ 7.54 ( m/ f) mg/ kg/ day LOAEL = 127/ 150 ( m/ f) mg/ kg/ day; based on decreased mean body weight gain, decreased mean food consumption ( f), decreased mean food efficiency, alterations in hematology parameters ( m); hemosiderin in kidneys ( f) 870.3150 90 Day oral toxicity in nonrodents NOAEL = 3.9/ 3.7 ( m/ f) mg/ kg/ day LOAEL = 146.9/ 159.9 ( m/ f) mg/ kg/ day based on decreased mean body weight and body weight gain, decreased hematocrit, hemoglobin, RBC` s, SGOT, SGPT, ALP, absolute and relative liver and testes weight; microscopic abnormalities of the liver and testes. 870.3200 21/ 28 Day dermal toxicity NOAEL = 1,000 mg/ kg/ day LOAEL = 1,000 mg/ kg/ day based on limit dose. 870.3700a Pre­ natal developmental in rodents Maternal NOAEL = 120 mg/ kg/ day LOAEL = 350 mg/ kg/ day based on decreased body weight gain, decreased food consumption and lower food efficiency. Developmental NOAEL = > 1,000 mg/ kg/ day limit dose LOAEL = > 1,000 mg/ kg/ day. 870.3700b Pre­ natal developmental in nonrodents Maternal NOAEL = 90 mg/ kg/ day LOAEL = 270 mg/ kg/ day based on clinical signs including absent/ reduced stool and stained fur, maternal death, increased abortions, decreased body weight gain, and lower­ food efficiency. Developmental NOAEL = 90 mg/ kg/ day LOAEL = 270 mg/ kg/ day based on increased abortions. VerDate May< 23> 2002 00: 52 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 12JNR1. SGM pfrm17 PsN: 12JNR1 40191 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Rules and Regulations TABLE 2. SUBCHRONIC, CHRONIC, AND OTHER TOXICITY Continued Guideline No. Study type Results 870.3800 Reproduction and fertility effects Parental/ Systemic NOAEL = 5.81/ 7.75 ( m/ f) mg/ kg/ day LOAEL = 44/ 58 mg/ kg/ day based on decreased body weight, decreased body weight gain, decreased food consumption, and decreased­ food efficiency. Reproductive NOAEL = 89.5/ 115 ( m/ f) mg/ kg/ day based on the absence of reproductive effects at the highest dose tested ( HDT). LOAEL = > 115 mg/ kg/ day. Offspring NOAEL = 5.81/ 7.75 ( m/ f) mg/ kg/ day LOAEL = 44/ 58 ( m/ f) mg/ kg/ day based on decreased F1 pup body weight on days 14 and 21 due to exposure via milk and in the diet. 870.4100a Chronic toxicity rodents NOAEL = 2.44 mg/ kg/ day LOAEL = 30.6 mg/ kg/ day based on decreased body weight and body weight gain, alteration in hematology ( mainly males) and increased incidences of interstitial cell hyperplasia in testes. 870.4100b Chronic toxicity dogs NOAEL = 26.9 mg/ kg/ day LOAEL = 116.6 mg/ kg/ day based on increased liver weight, alkaline phosphatase, and hepatocellular hypertrophy. 870.4200 Carcino­ genicity rats NOAEL = 2.44 mg/ kg/ day LOAEL = 30.6 mg/ kg/ day based on decreased body weight and body weight gain, alteration in hematology ( mainly males) and increased incidences of interstitial cell hyperplasia in the testes. ( Possible) evidence of carcinogenicity 870.4300 Carcino­ genicity mice NOAEL = 14.6 mg/ kg/ day LOAEL = 349 mg/ kg/ day based on increased liver weight and increased hepatic cell tumors ( adenomas and/ or carcinomas combined. ( Possible) evidence of carcinogenicity 870.5100 Gene Mutation No genotoxic effect in Ames assay using S. typhimurium. ( two studies) 870.5375 Cytogenetics No genotoxic effect in Chinese hampster ovary ( CHO) gene mutation assay 870.5375 870.5395 Other Effects Positive effects in the presence of metabolic activation, but inconclusive in the absence of metabolic activation in a chromosomal aberration/ human lymphocyte study. Mouse micronucleus assay negative for genotoxic effects. 870.6200a Acute neurotoxicity screening battery NOAEL = > 2,000 mg/ kg/ day HDT LOAEL = Not established 870.6200b Subchronic neurotoxicity screening battery NOAEL = 92.7/ 7.1 ( m/ f) mg/ kg/ day LOAEL = 186.2/ 51.6 ( m/ f) mg/ kg/ day based on decreased body weight and body weight gain. 870.7485 Metabolism and pharmacokinetics Urine major route of excretion at low doses and the feces at high doses. Ndesmethyl triflusulfuron methyl, the upper urinary metabolite composed between 25 44% of the dose at the low dose level ( single and repeated). Parent was the major component in the high dose feces and liver. 870.7600 Dermal penetration No dermal absorption studies were available. A 27% absorption was calculated from a ratio of the LOAEL from a developmental and 21 day dermal toxicity studies in rabbits. Special studies: In vivo and in vitro mechanic studies The purpose of these studies was to investigate the mechanism of Leydig cell tumor induction in the testes of male rats. A dose­ dependent decrease in aromatase enzyme activity was seen in vitro, but was inconclusive in vivo. B. Toxicological Endpoints The dose at which no adverse effects are observed, the NOAEL, from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern ( LOC). However, the lowest dose at which adverse effects of concern are identified, the LOAEL, is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor ( UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences. For dietary risk assessment ( other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose ( acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF ( RfD = NOAEL/ VerDate May< 23> 2002 00: 52 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 12JNR1. SGM pfrm17 PsN: 12JNR1 40192 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Rules and Regulations UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose ( aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA safety factor. For non­ dietary risk assessments ( other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF ( 10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures ( margin of exposure ( MOE) = NOAEL/ exposure) is calculated and compared to the LOC. The linear default risk methodology ( Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases ( e. g., risk is expressed as 1 x 10­ 6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non­ linear approach, a `` point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure ( MOEcancer= point of departure/ exposures) is calculated. A summary of the toxicological endpoints for triflusulfuron methyl used for human risk assessment is shown in Table 3 of this unit: TABLE 3. SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR TRIFLUSULFURON METHYL FOR USE IN HUMAN RISK ASSESSMENT Exposure scenario Dose used in risk assessment UF FQPA SF* and LOC for risk assessment Study and toxicological effects Acute Dietary ( all population subgroups) N/ A No toxicological effects attributable to a single exposure ( dose) were observed in oral toxicity studies. Therefore, an acute RfD can not be established and an acute dietary risk assessment will not be conducted for the general population. Chronic Dietary ( all populations) NOAEL = 2.44 mg/ kg/ day UF = 100 Chronic RfD = 0.024 mg/ kg/ day FQPA SF = 1x cPAD = chronic RfD ÷ FQPA SF = 0.024 mg/ kg/ day Chronic Toxicity in Rats LOAEL = 30.6 mg/ kg/ day based on decreased body weight and body weight gain, alter. In hematology ( mainly males), increased incidence of interstitial cell hyperplasia in testes. Cancer ( oral, dermal, inhalation) Triflusulfuron methyl is classified as a Group C possible human carcinogen chemical. * The reference to the FQPA safety factor refers to any additional safety factor retained due to concerns unique to the FQPA. C. Exposure Assessment 1. Dietary exposure from food and feed uses. Tolerances have been established ( 40 CFR 180.492) for the residues of triflusulfuron methyl in or on sugar beet, root and sugar beet, top. Risk assessments were conducted by EPA to assess dietary exposures from triflusulfuron methyl in food as follows: i. Acute exposure. Acute dietary risk assessments are performed for a fooduse pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1 day or single exposure. There are no effects attributable to a single, oral dose of triflusulfuron methyl. Therefore, an acute dietary risk assessment was not conducted. ii. Chronic exposure. In conducting this chronic dietary risk assessment, the Dietary Exposure Evaluation Model ( DEEMTM) analysis evaluated the individual food consumption as reported by respondents in the United States Department of Agriculture 1989 1992 Nationwide Continuing Surveys of Food Intake by Individuals ( CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Tolerance level residues and that 100% of the crop is treated. Because suitable data depicting residues of triflusulfuron methyl in drinking were not available for incorporation into the dietary exposure model, the dietary exposure estimates do not include potential exposure from drinking water. The dietary exposure is based on sugar beets, because chicory was not reported as being consumed in the 1989 1992 CSFII. Therefore, inclusion of chicory in the dietary analysis would not alter the exposure or risk estimates from those obtained from sugar beets. The cRfD or 0.024 mg/ kg/ day was determined where the NOAEL of 2.44 mg/ kg/ day is based on decreased body weight gain, alterations in hematology ( mainly in males) and increases in the incidence of interstitial hyperplasia in the testes at the LOAEL of 30.6 mg/ kg/ day. A 100 fold UF for interspecies extrapolation and intraspecies variability was applied. iii. Cancer. Triflusulfuron methyl is classified as a Group C possible human carcinogen chemical and for the purpose of risk characterization the RfD approach should be used for quantification of human risk. This decision was based on evidence of statistically significant, dose related increases in the incidence of interstitial cell adenomas of the testes at two doses, as well as statistically significant positive trend for these tumors in male rats. The testicular interstitial cell adenomas observed in the rat were benign. There was no reported increased tumor incidences of any type in the female rat and the dosing was adequate for assessing the carcinogenic potential of triflusulfuron methyl. Evidence of a hormonal mechanism for development of these benign tumors in rats does exist, however, the data were suggestive but not conclusive. Although there was some evidence of clastogenic activity for triflusulfuron methyl, positive results were only seen with activation in human lymphocytes/ chromosomal aberration assay. Triflusulfuron methyl is a member of a class of chemicals known as sulfonylureas. Of the 12 VerDate May< 23> 2002 00: 52 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 12JNR1. SGM pfrm17 PsN: 12JNR1 40193 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Rules and Regulations analogs structurally related to triflusulfuron methyl, three sulfonylureas have been associated with carcinogenicity in rodents. Primisulfuron methyl and prosulfuron are classified as Group D carcinogens ( not classifiable as to human carcinogenicity). Only tribenuron methyl is classified as a Group C carcinogen ( possible human carcinogen), however, a Q* for cancer risk assessment is not required because there is no evidence of genotoxicity and the increased incidence of mammary gland tumors is observed at doses which exceed the maximum tolerated dose. Therefore the RfD approach is appropriate for quantification of human cancer risk. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for triflusulfuron methyl in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of triflusulfuron methyl. The Agency uses the First Index Reservoir Screening Tool ( FIRST) or the Pesticide Root Zone/ Exposure Analysis Modeling System ( PRZM/ EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The SCI­ GROW model is used to predict pesticide concentrations in shallow ground water. For a screening­ level assessment for surface water EPA will use FIRST ( a tier 1 model) before using PRZM/ EXAMS ( a tier 2 model). The FIRST model is a subset of the PRZM/ EXAMS model that uses a specific highend runoff scenario for pesticides. While both FIRST and PRZM/ EXAMS incorporate an index reservoir environment, the PRZM/ EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin. None of these models include consideration of the impact, processing ( mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health LOCs. Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations ( EECs) from these models to quantify drinking water exposure and risk as a % RfD or % PAD. Instead drinking water levels of comparison ( DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to triflusulfuron methyl they are further discussed in the aggregate risk sections in Unit III. E. Based on the PRZM/ EXAMS and SCIGROW models the EECs of triflusulfuron methyl for acute exposures are estimated to be 0.42 parts per billion ( ppb) for surface water and 0.5 ppb for ground water. The EECs for chronic exposures are estimated to be 0.005 ppb for surface water and 0.5 ug/ L ( micrograms/ Liter) for ground water. 3. From non­ dietary exposure. The term `` residential exposure'' is used in this document to refer to nonoccupational non­ dietary exposure ( e. g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Triflusulfuron methyl is not registered for use on any sites that would result in residential exposure. 4. Cumulative exposure to substances with a common mechanism of toxicity. Section 408( b)( 2)( D)( v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider `` available information'' concerning the cumulative effects of a particular pesticide's residues and `` other substances that have a common mechanism of toxicity.'' EPA does not have, at this time, available data to determine whether triflusulfuron methyl has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, triflusulfuron methyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that triflusulfuron methyl has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances ( 62 FR 62961, November 26, 1997). D. Safety Factor for Infants and Children 1. In general. Section 408 of FFDCA provides that EPA shall apply an additional 10 fold margin of safety for infants and children in the case of threshold effects to account for pre­ natal and post­ natal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty ( safety) factors in calculating a dose level that poses no appreciable risk to humans. 2. Pre­ natal and post­ natal sensitivity. There is no quantitative or qualitative evidence of increased susceptibility of rat or rabbit fetuses to in utero exposure in the developmental studies. No developmental toxicity was seen at the limit dose ( 1,000 mg/ kg/ day) in rats. In rabbits, developmental toxicity manifested as abortions in the presence of severe maternal toxicity ( mortality, abortions, clinical signs, decreased body weight, and food efficiency). In the 2 generation reproductive toxicity study, the effects in the offspring ( decreased pup body weight in F1 on days 14 and 21; late lactation) can be attributed to the decreases in body weights seen in the parental animals. In addition, this decrease was seen only in the F1 generation but not in the second generation. There is no indication for a developmental neurotoxicity study since no neuropathological or neurobehavioral effects in the acute or subchronic neurotoxicity studies were observed; no alteration of the fetal nervous system was observed; and no evidence of neurotoxicity was found in other studies in the data base. 3. Conclusion. The toxicity data base for triflusulfuron methyl is complete except for a 28 day inhalation ( nose only) toxicity study. This study is of marginal value for the FFDCA determination because there are no residential uses of triflusulfuron methyl. Exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. Based on these reasons, the FQPA Safety Factor for the protection of children has been removed ( i. e. reduced to 1x.) E. Aggregate Risks and Determination of Safety To estimate total aggregate exposure to a pesticide from food, drinking water, VerDate May< 23> 2002 00: 52 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 12JNR1. SGM pfrm17 PsN: 12JNR1 40194 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Rules and Regulations and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure ( i. e., the PAD) is available for exposure through drinking water ( e. g., allowable chronic water exposure ( mg/ kg/ day) = cPAD ¥ ( average food + residential exposure)). This allowable exposure through drinking water is used to calculate a DWLOC. A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the EPA Office of Water are used to calculate DWLOCs: 2L/ 70 kg ( adult male), 2L/ 60 kg ( adult female), and 1L/ 10 kg ( child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening­ level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short­ term, intermediate­ term, chronic, and cancer. When EECs for surface water and ground water are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to the pesticide in drinking water ( when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process. 1. Acute risk. Because there are no effects attributable to a single, oral dose of triflusulfuron methyl is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to triflusulfuron methyl from food will utilize < 1% of the cPAD for the U. S. population, < 1% of the cPAD for infants < 1 year, and < 1% of the cPAD for children aged 1 6 years and children aged 7 12 years. There are no residential uses for triflusulfuron methyl that result in chronic residential exposure to triflusulfuron methyl. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 4 of this unit: TABLE 4. AGGREGATE RISK ASSESSMENT FOR CHRONIC ( NON­ CANCER) EXPOSURE TO TRIFLUSULFURON METHYL Population Subgroup cPAD mg/ kg/ day % cPAD ( food) Surface water EEC ( ppb) Ground water EEC ( ppb) Chronic DWLOC ( ppb) U. S. Population 0.000011 < 1 0.005 0.50 840 Female ( 13 50 years) 0.000009 < 1 0.005 0.50 720 All infants (< 1 year) 0.000040 < 1 0.005 0.50 240 Children ( 1 6 years) 0.000025 < 1 0.005 0.50 240 3. Short­ term risk. Short­ term aggregate exposure takes into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). Triflusulfuron methyl is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's LOC. 4. Intermediate­ term risk. Intermediate­ term aggregate exposure takes into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). Triflusulfuron methyl is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's LOC. 5. Aggregate cancer risk for U. S. population. Triflusulfuron methyl has been designated a Category C `` possible human carcinogen'' and does not require a separate cancer risk assessment. Because the RfD approach was determined appropriate for quanification of human cancer risk, the chronic aggregate risk assessment is sufficiently protective of human health. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to triflusulfuron methyl residues. IV. Other Considerations A. Analytical Enforcement Methodology An adequate tolerance enforcement method is available in PAM II. The method extracts residues of triflusulfuron methyl in a buffered acetonitrile solution, cleans the extract on a phenyl solid­ phase extraction cartridge, and quantitates residues on a HPLC/ UV system. B. International Residue Limits There are no Canadian or Codex MRLs established for triflusulfuron methyl. C. Conditions Submission of a 28 day inhalation ( nose only) toxicity study is required as condition of registration. V. Conclusion Therefore, the tolerances are established for residues of triflusulfuron methyl, methyl 2­[[[[[ 4­ ( dimethylamino)­ 6­( 2,2,2­ trifluoroethoxy)­ 1,3,5­ triazin­ 2­ yl] amino] carbonyl] amino] sulfonyl]­ 3­ methylbenzoate, in or on chicory, roots at 0.05 ppm; and time­ limited tolerances for sugar beet, root at 0.05 ppm and sugar beet, top at 0.05 ppm are converted to permanent tolerances and redefined as beet, sugar, roots and beet, sugar, tops. VI. Objections and Hearing Requests Under section 408( g) of FFDCA, as amended by the FQPA, any person may VerDate May< 23> 2002 00: 52 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00054 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 12JNR1. SGM pfrm17 PsN: 12JNR1 40195 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Rules and Regulations file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) of FFDCA provides essentially the same process for persons to `` object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d) of FFDCA, as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days. A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP 2002 0082 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before August 12, 2002. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 202) 260 4865. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305 5697, by e­ mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 2. Mail your copies, identified by docket ID number OPP 2002 0082, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 2. You may also send an electronic copy of your request via e­ mail to: oppdocket epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries. B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested ( 40 CFR 178.32). VII. Regulatory Assessment Requirements This final rule establishes a tolerance under FFDCA section 408( d) in response to a petition submitted to the Agency. The Office of Management and Budget ( OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104 4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low­ Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104 113, section 12( d) ( 15 U. S. C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408( d), such as the tolerance in this final rule, do not VerDate May< 23> 2002 00: 52 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 12JNR1. SGM pfrm17 PsN: 12JNR1 40196 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Rules and Regulations require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408( n)( 4). For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VIII. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule'' as defined by 5 U. S. C. 804( 2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 31, 2002. Peter Caulkins, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180 [ AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U. S. C. 321( q), 346( a) and 374. 2. Section 180.492 is revised to read as follows: § 180.492 Triflusulfuron methyl; tolerances for residues. ( a) General. Tolerances are established for residues of the herbicide, triflusulfuron methyl 2­[[[[[ 4­ ( dimethylamino)­ 6­( 2,2,2­ trifluoroethoxy)­ 1,3,5­ triazin­ 2­ yl] amino] carbonyl] amino] sulfonyl]­ 3­ methylbenzoate in or on the raw agricultural commodities: Commodity Parts per million Beet, sugar, roots ..... 0.05 Beet, sugar, tops ....... 0.05 Chicory, roots ............ 0.05 ( b) Section 18 emergency exemptions. [ Reserved] ( c) Tolerances with regional registrations. [ Reserved] ( d) Indirect or inadvertent residues. [ Reserved] [ FR Doc. 02 14501 Filed 6 11 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP 2002 0099; FRL 7182 1] RIN 2070 AB78 Spinosad; Time­ Limited Pesticide Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule. SUMMARY: This regulation establishes a time­ limited tolerance for residues/ combined residues of spinosad in or on stored grains ( barley, corn, oats, rice, sorghum/ milo, and wheat). Dow AgroSciences LLC requested this tolerance under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act ( FQPA) of 1996. The tolerance will expire on May 31, 2004. This timelimited tolerance is to permit the marketing of stored grains in accordance with the Experimental Use Permit ( EUP) 62719­ EUP­ 50 which is being issued concurrently. DATES: This regulation is effective June 12, 2002. Objections and requests for hearings, identified by docket ID number OPP 2002 0099, must be received on or before August 12, 2002. ADDRESSES: Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket ID number OPP 2002 0099 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: William G. Sproat, Jr., Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 703 308 8587; e­ mail address: sproat. william@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide VerDate May< 23> 2002 00: 52 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00056 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 12JNR1. SGM pfrm17 PsN: 12JNR1

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2024-06-07T20:31:41.963352

regulations

EPA-HQ-OPP-2002-0083-0023

Supporting & Related Material

OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 June 19, 2002 MEMORANDUM SUBJECT: Cancellation of the June 25, 2002 FIFRA SAP Consultation Session Status Report on Organophosphorus Pesticide Cumulative Risk Estimates: Comparison of Outputs from Three Models (Calendex J , Lifeline J and Cares J ) TO: Docket Number : OPP­ 2002­ 0083 FROM: Olga Odiott, Designated Federal Official FIFRA Scientific Advisory Panel Office of Science Coordination and Policy The June 25, 2002 Session of the FIFRA SAP Meetings scheduled from June 25 ­ June 27 has been cancelled. The sessions scheduled for June 26 and June 27 will proceed as scheduled. A note announcing the cancellation of the June 25, 2002 Session has been posted to the FIFRA SAP Web site at http:// www. epa. gov/ scipoly/ sap/.

epa

2024-06-07T20:31:41.974060

regulations

EPA-HQ-OPP-2002-0083-0041

Supporting & Related Material

1 July 19, 2002 MEMORANDUM SUBJECT: Transmittal of Meeting Minutes of the FIFRA Scientific Advisory Panel Meeting Held June 26­ 27, 2002 TO: Marcia E. Mulkey, Director Office of Pesticide Programs FROM: Paul I. Lewis, Designated Federal Official FIFRA Scientific Advisory Panel Office of Science Coordination and Policy THRU: Larry C. Dorsey, Executive Secretary FIFRA Scientific Advisory Panel Office of Science Coordination and Policy Sherell A. Sterling, Acting Director Office of Science Coordination and Policy Please find attached the meeting minutes of the FIFRA Scientific Advisory Panel open meeting held in Arlington, Virginia from June 26­ 27, 2002. This report addresses a set of scientific issues being considered by the Environmental Protection Agency regarding determination of the appropriate FQPA Safety Factor( s) in the organophosphorous pesticide cumulative risk assessment: susceptibility and sensitivity to the common mechanism, acetylcholinesterase inhibition. Attachment 2 cc: Stephen Johnson Susan Hazen Adam Sharp James Jones Janet Andersen Debbie Edwards Anne Lindsay Steve Bradbury Denise Keehner Linda Moos Lois Rossi Frank Sanders Margaret Stasikowski William Jordan Antonio Bravo Douglas Parsons David Deegan Vanessa Vu (SAB) OPP Docket FIFRA Scientific Advisory Panel Members Stephen M. Roberts, Ph. D. Fumio Matsumura, Ph. D. Herbert Needleman, M. D. Christopher J. Portier, Ph. D. Mary Anna Thrall, D. V. M. FQPA Science Review Board Members John Bigbee, Ph. D. William Brimijoin, Ph. D. Amira T. Eldefrawi, Ph. D. Jean Harry, Ph. D. Dale Hattis, Ph. D. George Lambert, M. D. Michael McClain, Ph. D. Carey Pope, Ph. D. Nu­ May Ruby Reed, Ph. D. Lester Sultatos, Ph. D. 3 SAP Meeting Minutes No. 2002­ 03 June 26­ 27, 2002 FIFRA Scientific Advisory Panel Meeting, held at the Sheraton Crystal City Hotel, Arlington, Virginia A Set of Scientific Issues Being Considered by the Environmental Protection Agency Regarding: Determination of the Appropriate FQPA Safety Factor( s) in the Organophosphorous Pesticide Cumulative Risk Assessment: Susceptibility and Sensitivity to the Common Mechanism, Acetylcholinesterase Inhibition 4 NOTICE This report has been written as part of the activities of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Scientific Advisory Panel (SAP). This report has not been reviewed for approval by the United States Environmental Protection Agency (Agency) and, hence, the contents of this report do not necessarily represent the views and policies of the Agency, nor of other agencies in the Executive Branch of the Federal government, nor does mention of trade names or commercial products constitute a recommendation for use. The FIFRA SAP was established under the provisions of FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, to provide advice, information, and recommendations to the Agency Administrator on pesticides and pesticide­ related issues regarding the impact of regulatory actions on health and the environment. The Panel serves as the primary scientific peer review mechanism of the EPA, Office of Pesticide Programs (OPP), and is structured to provide balanced expert assessment of pesticide and pesticide­ related matters facing the Agency. Food Quality Protection Act Science Review Board members serve the FIFRA SAP on an ad­ hoc basis to assist in reviews conducted by the FIFRA SAP. Further information about FIFRA SAP reports and activities can be obtained from its website at http:// www. epa. gov/ scipoly/ sap/ or the OPP Docket at (703) 305­ 5805. Interested persons are invited to contact Larry Dorsey, SAP Executive Secretary, via e­ mail at dorsey. larry@. epa. gov. 5 SAP Meeting Minutes No. 2002­ 03 FIFRA Scientific Advisory Panel Meeting, June 26­ 27, 2002, held at the Sheraton Crystal City Hotel, Arlington, Virginia A Set of Scientific Issues Being Considered by the Environmental Protection Agency Regarding: Determination of the Appropriate FQPA Safety Factor( s) in the Organophosphorous Pesticide Cumulative Risk Assessment: Susceptibility and Sensitivity to the Common Mechanism, Acetylcholinesterase Inhibition Mr. Paul Lewis Stephen M. Roberts, Ph. D. Designated Federal Official FIFRA SAP Session Chair FIFRA Scientific Advisory Panel FIFRA Scientific Advisory Panel Date: July 19, 2002 Date: July 19, 2002 6 Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel Meeting June 26­ 27, 2002 Determination of the Appropriate FQPA Safety Factor( s) in the Organophosphorous Pesticide Cumulative Risk Assessment: Susceptibility and Sensitivity to the Common Mechanism, Acetylcholinesterase Inhibition PARTICIPANTS FIFRA SAP Session Chair Stephen M. Roberts, Ph. D., University of Florida, Gainesville, FL Designated Federal Official Mr. Paul Lewis, FIFRA Scientific Advisory Panel Staff, Office of Science Coordination and Policy FIFRA Scientific Advisory Panel Fumio Matsumura, Ph. D., University of California at Davis, Davis, CA Herbert Needleman, M. D., University of Pittsburgh, Pittsburgh, PA Christopher J. Portier, Ph. D., National Institute of Environmental Health Science Research Triangle Park, NC Mary Anna Thrall, D. V. M., Colorado State University, Fort Collins, CO FQPA Science Review Board Members John Bigbee, Ph. D., Virginia Commonwealth University, Richmond, VA William Brimijoin, Ph. D., Mayo Clinic and Medical School, Rochester, MN Amira T. Eldefrawi, Ph. D., University of Maryland School of Medicine, Baltimore, MD Jean Harry, Ph. D., National Institute of Environmental Health Science, Research Triangle Park, NC Dale Hattis, Ph. D., Clark University, Worcester, MA George Lambert, M. D., Environmental and Occupational Health Sciences Institute, UMDNJ, Piscataway, NJ Michael McClain, Ph. D., McClain and Associates, Randolph, NJ Carey Pope, Ph. D., Oklahoma State University, Stillwater, OK Nu­ May Ruby Reed, Ph. D., California Environmental Protection Agency, Sacramento, CA Lester Sultatos, Ph. D., New Jersey Medical School, Newark, NJ INTRODUCTION The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Scientific Advisory Panel (SAP) has completed its review of the set of scientific issues being considered by the 7 Agency pertaining to determination of the appropriate FQPA Safety Factor( s) in the organophosphorous pesticide cumulative risk assessment: susceptibility and sensitivity to the common mechanism, acetylcholinesterase inhibition. Advance notice of the meeting was published in the Federal Register on May 31, 2002. The review was conducted in an open Panel meeting held in Arlington, Virginia, on June 26­ 27, 2002. The meeting was chaired by Dr. Stephen Roberts. Mr. Paul Lewis served as the Designated Federal Official. Before the Agency presentation on issues pertaining to determination of the appropriate FQPA safety factor, Mr. Francis B. Suhre (Office of Pesticide Programs, EPA) provided the Panel a status report on organophosporus pesticide cumulative risk estimates: comparison of outputs from different models. Vicki Dellarco, Ph. D. (Office of Pesticide Programs, EPA), began the Agency presentations by providing an introduction and overview of the approach to evaluating susceptibility/ sensitivity of children in cumulative risk assessments and review of available animal studies. Stephanie Padilla, Ph. D. (Office of Research and Development, EPA) summarized age dependent sensitivity and susceptibility. Vicki Dellarco, Ph. D. (Office of Pesticide Programs, EPA) ended the Agency presentation by discussing the risk characterization of sensitivity and susceptibility. Other EPA participants were Randy Perfetti, Ph. D. (Office of Pesticide Programs, EPA) and Karl Baetcke, Ph. D. (Office of Pesticide Programs, EPA). In preparing these meeting minutes, the Panel carefully considered all information provided and presented by the Agency presenters, as well as information presented by public commenters. These meeting minutes address the information provided and presented at the meeting, especially the response to the charge by the Agency. PUBLIC COMMENTERS Oral statements were made by: Jennifer Sass, Ph. D., on behalf of the Natural Resources Defense Council Angelina Duggan, Ph. D., on behalf of Sound Science Policy Alliance Larry Sheets, Ph. D., Bayer Crop Science, on behalf of CropLife America James Gibson, Ph. D., The Brody School of Medicine of Eastern Carolina University, on behalf of Sound Science Policy Alliance Jack M. Zabik, Ph. D., Dow AgroSciences, on behalf on CropLife America 8 Mr. Ed Gray, McDermott Will and Emery, on behalf of FQPA­ Implementation Working Group Mr. Art Beltrone, private citizen Judith Schreiber, Ph. D. State of New York, Office of the Attorney General Written statements were received as follows: No written comments were received. CHARGE Issue 1. Role of Cholinesterases and Acetylcholine As discussed in the EPA report, inhibition of acetylcholinesterase (AChE) in the young can result in cholinergic toxicity as in the adult, but evidence has also been emerging over the last several years that indicates that AChE and acetylcholine may serve as neuromodulators in development. Question 1.1 Please comment on the extent to which the report adequately summarizes the current state of knowledge. Does the scientific evidence support the conclusion that perturbation of the cholinergic nervous system during development by inhibiting AChE can potentially lead to deficits in the structure and function of the central and peripheral nervous systems? Issue 2. Age­ Dependent Sensitivity to Cholinesterase inhibition in Animal Studies Age­ dependent sensitivity (i. e., young animals can exhibit higher levels of cholinesterase (ChE) inhibition at the same dose or inhibition at lower doses compared to adults) has been observed in several laboratory studies following treatment (acute and/ or repeated oral gavage doses) of neonatal, juvenile, and adult rats with organophosphorus (OP) pesticides. The exact mechanisms of this age­ dependent sensitivity are not known, but several studies have demonstrated that toxicokinetic factors may be responsible. Most notably, the more limited ability of the young to detoxify OP pesticides by A­ esterases and carboxylesterases appears to be an important factor underlying the increased sensitivity of the immature rat to ChE inhibition. There appears to be more rapid recovery of inhibited AChE (synthesis of new ChE enzyme) in postnatal (and fetal) rat tissues, but information on comparative recovery in children and human adults is lacking. Question 2.1 Please comment on the extent to which the report adequately discussed and summarized 9 the current understanding of age­ dependent sensitivity to ChE inhibition, the prevailing views in the scientific community concerning the biological factors involved, and the role esterases may play as a major factor accounting for potential increased sensitivity of the immature rat. Question 2.2 Please comment on the timing of administration (i. e., the developmental stage treated) and the differential found between adults and the young animal. Question 2.3 Please comment on the extent to which comparative ChE data on six OP pesticides (chlorpyrifos, diazinon, dimethoate, methamidophos, malathion, methyl parathion) may represent a reasonable subset of different structural and pharmacokinetic characteristics of the cumulative group of OP pesticides to define an upper bound on the differential sensitivity that may be expected at different life stages of the immature animal. As an example, there are no chemicalspecific comparative cholinesterase data on azinphos­ methyl (AZM), an important contributor of risk for the food pathway. Pesticide­ specific comparative cholinesterase data on the other six pesticides from the OP class (including data on malathion, a member of the same chemical subgroup as AZM) show a limited range of differential sensitivities ­­ from one­ fold (no increased sensitivity) up to three­ fold ­­ between the young and adults. EPA regards these data on other OPs as providing sufficient evidence to assess the potential for AZM to show age­ dependent sensitivity, and to reasonably predict the degree of potential difference in sensitivity between the young and adults. Given the results of the other OPs, EPA concludes that it is unlikely that AZM would exceed a magnitude of difference greater than approximately 3­ fold following treatment of PND 11 through 21 pups versus adult animals. Issue 3. Relevance of the Animal Findings to Children Age dependent sensitivity to cholinesterase inhibition has been associated with the limited ability of the immature rat to detoxify OP pesticides by esterases. In rats, A­ esterase activity increases from birth to reach adult levels around postnatal day 21. Fetal rats possess very little carboxylesterase activity with increasing activity as the postnatal rat matures, reaching adult values after puberty (50 days of age). Data showing increased sensitivity of the young animal to cholinesterase inhibition compared to adults has generally been derived from acute dosing of PND 7 or PND 11 pups, or repeated dosing of PND 11 to PND 21 pups. The available data also show as the young rat rapidly matures in its ability to detoxify by esterases, the differential in cholinesterase inhibition becomes smaller. Thus, the relative sensitivities of immature rats found in the studies of dosing pups through PND 11 to 21 are smaller compared to studies of dosing a PND 11 pup. The dosing studies of PND 11 through 21 pups are considered to better approximate the maturation profile of the A­ esterases of the highly exposed children's age group in the OP cumulative risk assessment, the one and two year olds, compared to a study of a PND 11 pup which is similar to a newborn. Thus, the repeated rat dosing studies more closely mimic 10 the maturation or developmental profile of A­ esterase appearance in children around the one and two year olds where children are reaching adult levels of A­ esterase activity. The use of dosing studies of PND 11 through 21 is consistent with the exposure patterns of children. Humans generally do not begin to consume fresh (uncooked) fruits and vegetables until after six months of age or more. Furthermore, repeated dosing studies were used to determine relative sensitivity because people are exposed every day to an OP pesticide through food, and thus an animal study using repeat exposures is considered appropriate. Finally, following exposure to an OP, regeneration of cholinesterase to pre­ exposure levels does not occur for days or weeks, making the exposed individual potentially more vulnerable to subsequent exposures during that period. Question 3.1 Please comment on the maturation profile of A­ esterase and the uncertainties surrounding these data in young children. Because no human data are available on the maturation profile of carboxylesterases, please comment on what should be assumed in humans, especially children age 1 to 2 years, given the animal data and what science understands in general about detoxification maturation profiles. Question 3.2 Please comment on the extent to which the biological understanding of observed agedependent sensitivity to cholinesterase inhibition in laboratory animal studies informs our understanding about the likelihood of similar effects occurring in children; in particular, what can be inferred from animal and human information regarding the potential for different age groups to show increased sensitivity if exposed to cholinesterase­ inhibiting pesticides. Does the scientific evidence support the conclusion that infants and children are potentially more sensitive to organophosphorus cholinesterase inhibitors? Question 3.3 Please comment on the conclusions regarding the faster recovery in the young animal of AChE activity. Because there is no human information on the recovery of AChE in children compared to adults, please comment on the extent to which recovery of AChE in children should be factored into conclusions regarding potential risk to children. PANEL CONSIDERATION OF AGENCY APPLICATION OF THE FQPA SAFETY FACTOR The Panel was not explicitly charged with making a determination as to whether the EPA, in the Agency background document developed for this meeting, had made an appropriate choice of a 3x versus the presumptive 10x FQPA safety factor, and the rational 11 for its decision. Nonetheless, discussion of this point arose several times during the two­ day Panel session. Given the importance of the issue, an attempt is made here to summarize the views expressed by Panel members along with the logic behind these views. The Panel recognizes that it is constituted as a technical advisory body, not a group intended to provide legal/ policy advice. However the choice to apply particular FQPA safety factors in EPA's cumulative risk analysis clearly involves both policy and science. A legal/ policy interpretation is needed to define the standard of evidence required to depart from the mandated default 10­ fold factor in any ultimate risk management decisions that might be made on the basis of the cumulative risk analysis. Technical judgments are also needed in assessing whether any particular standard of evidence has been met by the data available for individual organophosphate pesticides or AChE inhibitors as a common mechanism group. The discussion below summarizes the Panel's assessment of the scientific evidence pertaining to the FQPA safety factor. A majority of the Panel members who commented on the Agency decision of an appropriate FQPA safety factor disagreed with the Agency's proposal to deal with the FQPA requirements to ensure protection of infants and children by selective application of a 3X safety factor. These Panel members concluded that the confidence with the available data was not sufficient to assure adequate protection with less than the 10x FQPA safety factor. Other Panel members were prepared to accept the EPA proposal, some with certain reservations. The Agency has proposed not to apply the full 10x FQPA safety factor in cases where animal studies have indicated that younger animals (rats) are no more sensitive than adults to AChE inhibition by repeated (as opposed to single dose) exposure to OPs. Where there are data that indicate no greater sensitivity for cholinergic inhibition in weanling animals than in adults, the Agency would apply no special, additional safety factor. The Agency proposes to apply a 3X safety factor (described as a database uncertainty factor) in cases of chemicals that have been shown to be about three­ fold more potent as AChE inhibitors in weanling rats than in adults. The Agency also proposes to apply the same safety factor to the 24 remaining chemicals currently under review, while awaiting receipt of new data from ongoing studies of developmental neurotoxicity in rats. Various reasons were cited by the Panel members who recommended instead that the EPA apply across the board a uniform 10X FQPA safety factor. The most widely cited reason for this recommendation was a concern that the existing animal database does not provide sufficient assurance that young children are not at substantially greater risk than adults from exposures to OPs. This concern was based on the uncertainties arising from several deficiencies in the EPA's cumulative risk analysis. These deficiencies include the following: 1. Extrapolation from data on a limited set of compounds. The EPA's proposal to use a 3­ fold factor for the cumulative risk assessment is based on relative sensitivity to cholinesterase inhibition from a set of six organophosphorus toxicants. At 12 most, an approximate 3­ fold difference in sensitivity to cholinesterase inhibition was noted in younger animals following repeated dosing. The EPA considered that this subset of compounds represents the range of variability of differential responses for all 30 compounds under consideration. The age­ dependence of differences in sensitivity to cholinesterase inhibition by the other 24 OP toxicants is unknown. This data gap alone was felt to make it prudent to accept the 10x default. 2. Uncertainties about the mechanisms of age­ dependent sensitivity in young rats and their applicability to human beings. Even with the six compounds known to have relatively small age­ dependent sensitivity in young rats, the extrapolation to humans is problematic. First, the mechanism of age­ dependent sensitivity in rats has not yet been fully elucidated. More important, we lack comprehensive information about the relative biotransformation capacities for OPs in young and adult humans, and about the relative rates of enzyme recovery by de novo synthesis and other mechanisms. Without detailed information of this sort (admittedly difficult to obtain) we cannot be sure that the relatively rapid decrease in OP sensitivity in weanling rats will also apply to children in the critical 1­ 2 year age group. 3. Limitations of animal models to identify effects of cholinesterase inhibition in children While the Agency noted that the OP cumulative risk assessment is based on AChE inhibition and cholinergic toxicity, more relevant indications of whether an exposure to OPs are " safe for children'' are needed, specifically behavioral and cognitive measures such as IQ, attention, language function, etc. Much uncertainty is introduced by using AChE inhibition as a surrogate for these endpoints. For example, as was pointed out at the meeting, it is not known whether a given level of AChE inhibition has the same consequences for a young child as for an adult. Information is largely lacking about the sensitivity, specificity and predictive power of AChE inhibition as a marker for neurobehavioral effects of OPs based on current animal models. In addition, such information is also lacking in terms of high quality epidemiological studies of exposure to pesticides to infants and children. Particularly, the lack of long term neurobehavioral studies at any stage of development creates a great deal on uncertainty in trying to identify the risks of the OPs to children. 4. Uncertainties about the potential frequency of "high­ level exposure". Another consideration in the application of the FQPA safety factor is confidence in the extent to which the exposure assessment truly captures high­ end exposures, particularly in children. One Panel member pointed out that although the Agency proposes to consider upper percentile estimates of exposure in the cumulative risk assessment, these estimates may not be as high as the percentiles imply. As evidence for this, an example was cited in which consumption of small amounts of a single food item (e. g., apple or pear) containing a single OP at the upper end of its PDP range could result in exposure above the 95 th percentile for cumulative dietary 13 exposure calculated by the Agency. In view of this, an argument could be made for an additional FQPA safety factor if the benchmark for risk management decision is a percentile of exposure that does not adequately address infrequent, but not truly rare, exposure events. While aware of all these issues, other Panel members nonetheless considered that the Agency's proposal for a 3X safety factor was reasonable, with certain provisions. The major provision asked for by some of these panel members was to use 3X safety factors even for agents that showed no age­ dependent sensitivity in rats and an increase to 10X in the case of agents that have not yet been evaluated for potential age­ dependent sensitivity. This position was based on a reasonable level of confidence in the existing animal database for the six different OP anticholinesterases so far evaluated for age­ dependent sensitivity. This database showed no compounds with more than 3X greater potency in weanling than in adult rats, and several that show identical potency in these two age groups (e. g., methamidophos). Reasonable confidence was expressed that the animal data can be extrapolated to humans in light of the recent data that illuminate the mechanisms underlying age­ dependent sensitivity to OP anticholinesterases in the rat. These data demonstrate that at least a large portion of the age dependent sensitivity reflects the maturation profiles of enzymes involved in metabolism and elimination of such agents. Although comparative information on humans is not complete, the species extrapolation is strengthened by information on A­ esterase maturation indicating similarly rapid maturation during the period equivalent to early infancy, with near adult levels reached by the time of weaning in rats in humans. Finally, one Panel member noted that many of the agents in question have been in use for decades and yet, despite isolated cases of acute toxicity, no clear evidence of developmental abnormalities has emerged. DETAILED RESPONSE TO THE AGENCY'S CHARGE The specific issues to be addressed by the Panel are keyed to the Agency's background document, dated June 3, 2002, and are presented as follows: Issue 1. Role of Cholinesterases and Acetylcholine As discussed in the EPA report, inhibition of acetylcholinesterase (AChE) in the young can result in cholinergic toxicity as in the adult, but evidence has also been emerging over the last several years that indicates that AChE and acetylcholine may serve as neuromodulators in development. Question 1.1 Please comment on the extent to which the report adequately summarizes the current state of knowledge. Does the scientific evidence support the conclusion that perturbation of the cholinergic nervous system during development by inhibiting AChE can potentially lead to deficits in the structure and function of the central and peripheral nervous systems? 14 As discussed in the EPA report, inhibition of acetylcholinesterase (AChE) in the young can result in cholinergic toxicity as in the adult, but evidence has also been emerging over the last several years to indicate that AChE and acetylcholine (ACh) may serve as neuromodulators in development. The Panel concluded that there is a significant potential that brain development could be affected by any agent that blocks the activity of AChE and raises the level of synaptic (or nonsynaptic acetylcholine. Thus the Panel agreed that the scientific evidence support the conclusion that perturbation of the cholinergic nervous system during development, by inhibiting AChE, could potentially lead to deficits in the structure and function of the central and peripheral nervous systems. Overview The Panel commends the Agency on the preparation of the section of the report dealing with the potential role( s) of organophosphate (OP) inhibitors on the structure and function of the developing nervous system. Section II A of the report presents information regarding the roles of acetylcholine and AChE in neurodevelopment. It is well known that inhibition of AChE catalytic function leads to the accumulation of acetylcholine, which in addition to its role in cholinergic transmission, also participates in the structural development of neurons. Compelling evidence demonstrates that AChE is a multifunctional protein with a catalytic domain and a surface adhesive domain that may be important for morphogenesis in the nervous system. In vitro studies in which the adhesive site is perturbed have clearly demonstrated a direct developmental role for this domain in both the central and peripheral nervous systems. Finally, inhibition of AChE in the adult leads to the expression of a novel AChE isoform (AChE­ R) which has a different tissue distribution from the normal synaptic form (AChE­ S) and may serve different functions. Thus, the potential effect( s) of OP inhibitors on the developing nervous system are complex. An elaboration of the Panel's position is provided below. Elevated acetylcholine levels and neuronal development The cumulative risk assessment of OP anti­ AChEs is based on their common mechanism of toxicity, i. e., phosphorylation of AChE leading to accumulation of acetylcholine and consequent cholinergic signs of toxicity. Importantly, acetylcholine is itself a neuromodulator. Thus, the elevated levels of acetylcholine, subsequent to AChE inhibition, might disrupt neurodevelopment by affecting axonal outgrowth and guidance (Coronas, et al., 2000; Wessler, et al., 1998). The published data provide ample evidence that acetylcholine modulates neural growth and plasticity in addition to its well­ known role in interneuronal, neuromuscular and neuroglandular signal transmission. Acetylcholine effects are mediated by diverse subtypes of ionotropic and metabotropic receptors. Inhibition of synaptic AChE by OPs causes excessive activation of nicotinic and muscarinic receptors. The former responds by rapid conformational change to an inactive, desensitized state. On the other hand, muscarinic receptors respond by 15 down regulation (i. e. their numbers are reduced). The functional impact of such changes on the developing brain would be very serious if they were prolonged, for example, if AChE activity does not recover. Eskenazi and co­ workers (1999) recently reviewed the evidence that repeated low­ level exposure of animals to OP pesticides might affect neurodevelopment and growth in developing animals. For example, animal studies have reported neurobehavioral effects such as impairment on maze performance, locomotion, and balance in neonates exposed in utero and during early postnatal periods. Possible mechanisms for these effects include inhibition of brain AChE, downregulation of muscarinic receptors, decreased brain DNA synthesis, and reduced brain weight in the offspring. Research findings also suggest that it is biologically plausible that OP exposure may cause dysregulation of the autonomic nervous system. Downstream effects at multiple sites, including the lungs, could predispose children to a variety of disabilities. All such changes can be considered endpoints elicited by the common mechanism of toxicity and must be anticipated from exposure to any OP anticholinesterase. Another downstream effect that could potentially result from the common mechanism of OP toxicity is the compensatory upregulation of novel forms of AChE that do not function quite like the normal forms. Some recent research suggests that inhibition of AChE in adults stimulates production of an AChE variant known as "read­ through" AChE (because the normal transcriptional splicing at the C­ terminus is omitted). The major AChE expressed in nervous tissue is the so­ called "synaptic" form. Chronic inhibition of AChE activity can lead to the expression of the unique "read­ through" product, which is secreted as a monomer (Grisaru, et al., 1999; Soreq, H. and S. Seidman, 2001). This protein has the same enzyme kinetics as the synaptic form and thus would behave like other forms of AChE in a typical assay. However, because read­ through AChE has a different distribution within the cell, and from tissue to tissue, it may not have the same functional impact as normal AChE. The presence of read­ through AChE has not yet been described in the fetus or the neonate, nor has there been any study of the potential for developmentally significant modulation of this form after OP exposure. Nonetheless, the possibility of such effects, or additional changes in protein expression that may eventually be revealed by proteomic studies, reinforces concerns that OPs might exert developmental neurotoxicity through their common mode of action. These observations also give rise to a concern that apparent recovery of assayed total brain cholinesterase following OP inhibition might not indicate a return to a completely normal state in a developing nervous system. Direct role for AChE in development There is also evidence that AChE inhibitors could disturb neuronal development by mechanisms in addition to the common mode of action. AChE is developmentally expressed by neurons during axonal outgrowth and migration, periods when its role in terminating cholinergic transmission would be unnecessary (Drews, U. 1975; Grisaru, et al., 1999; Layer, P. G. and E. Willbold. 1995; Soreq, H. and S. Seidman. 2001). Experimental studies in vitro, involving perturbation of AChE either by certain non­ OP AChE inhibitors or AChE­ specific antibodies, 16 confirm a specific developmental role for AChE (Bigbee, et al., 1999; Dupree and Bigbee. 1994; Layer, P. G., et al., 1993). In addition, observations by Slotkin and collaborators have demonstrated persistent neurobehavioral and DNA/ protein abnormalities in rats subjected to moderate or low dose AChE inhibitor treatment in utero or in an early postnatal period. A direct role for AChE in the process of neural development has also been demonstrated by genetic manipulation of AChE expression, either by stable transfection or by antisense treatment (Bigbee, et al., 2000; Brimijoin, S. and C. Koenigsberger. 1999; Grisaru, et al., 1999; Sternfeld, et al., 1998). In tissue culture, AChE that is catalytically inactivated by point mutation of the active site serine can still support some morphogenic phenomena (Sternfeld, et al., 1998). Such findings indicate that the morphogenic potential of this enzyme is at least partially independent of its esterase activity, possibly because of morphogenic properties in the adhesive domain surrounding the opening of the active site gorge. Results from studies using transgenic mice, however, have produced results that raise questions about the significance of adhesion­ based functions of AChE in brain development. In one study, it was shown that neuronal development and structure of the brain are apparently normal in AChE knockout heterozygote mice that have only 50% of normal AChE expression levels (Xie et al. 2000). Even complete AChE knockout causes no profound changes in the structure of cholinergic pathways in the brain as revealed by histochemistry and immunohistochemistry (Mesulam et al., 2002). It can also be questioned whether OPs are likely to influence the adhesive functions of AChE, in contrast to certain long­ chain, bis­ quaternary AChE inhibitors that bind reversibly to catalytic and peripheral sites. No evidence exists to indicate that OPs bind to the adhesive domain. On the other hand, as pointed out in the EPA report, the possibility exists that an OP could alter the three­ dimensional structure of AChE by binding to the active site, thereby subtly altering the surface adhesive domain. For this reason, as was pointed out by one Panel member, there is need for additional pharmacodynamic studies to better define the different OPs and their structural interactions with AChE. At present, it would be prudent to recognize the potential for developmental toxicity stemming from mechanisms that operate in addition to the common mode of OP toxicity. Thus we must recognize that the degree of AChE inhibition may not fully capture the ability of an OP to perturb the development of the nervous system. AChE is uniquely high during critical periods of development and thus may be especially vulnerable for short periods. Furthermore, a given degree of inhibition of AChE in the fetus or neonate may have a greater effect than the same level of inhibition in the adult. However, the current review is almost completely qualitative. There is no quantitative analysis relating either the presence or the extent of developmental effects and duration of measured or estimated cholinesterase inhibition in the developing brain. This quantitative component is a key missing link in the chain of analysis that is needed to assess whether the degree of cholinesterase inhibition that has been judged statistically detectable for adults should also be expected to be without appreciable consequence during development. 17 The Panel generally agreed that the existing evidence falls short of what would be needed to prove that AChE inhibition during development will cause later deficits in nervous system structure and function. However, while definitive evidence is lacking, the potential nevertheless exists. Of particular importance to the risk assessment of OP toxicants, more recent information suggests that some OP inhibitors of AChE can modify neuronal growth in vitro. It should be stressed, however (as noted in the Report) that some anticholinesterases have no apparent effect on neurite outgrowth. Some studies suggest that neurodevelopment may be affected in vivo by some OP toxicants, but most of these studies utilize unrealistic exposure conditions and thus have uncertain relevance for risk assessment. In addition, there could be very subtle changes not disclosed by standard behavioral tasks. The two best­ described systems are both sensory in nature and are difficult to assess. The report did not summarize the studies for neuro­ behavioral effects from fetal exposure to the OPs. Thus it is difficult to determine whether there is a common potential for neurological and behavioral effects. This issue needs greater clarification in the document, especially as it relates to registrant­ provided developmental neurotoxicity (DNT) studies. Without this comprehensive review and evaluation of a larger number of DNT studies, it is difficult to assess whether the existing data support or refute a common, additional developmental risk above the adult risk, for a common level of AChE inhibition. Issue 2. Age­ Dependent Sensitivity to Cholinesterase inhibition in Animal Studies Age­ dependent sensitivity (i. e., young animals can exhibit higher levels of cholinesterase (ChE) inhibition at the same dose or inhibition at lower doses compared to adults) has been observed in several laboratory studies following treatment (acute and/ or repeated oral gavage doses) of neonatal, juvenile, and adult rats with organophosphorus (OP) pesticides. The exact mechanisms of this age­ dependent sensitivity are not known, but several studies have demonstrated that toxicokinetic factors may be responsible. Most notably, the more limited ability of the young to detoxify OP pesticides by A­ esterases and carboxylesterases appears to be an important factor underlying the increased sensitivity of the immature rat to ChE inhibition. There appears to be more rapid recovery of inhibited AChE (synthesis of new ChE enzyme) in postnatal (and fetal) rat tissues, but information on comparative recovery in children and human adults is lacking. Question 2.1 Please comment on the extent to which the report adequately discussed and summarized the current understanding of age­ dependent sensitivity to ChE inhibition, the prevailing views in the scientific community concerning the biological factors involved, and the role esterases may play as a major factor accounting for potential increased sensitivity of the immature rat. Age­ dependent sensitivity (i. e., young animals can exhibit higher levels of cholinesterase (ChE) inhibition at the same dose, or inhibition at lower doses compared to adults) has been observed in several laboratory studies following treatment (acute and/ or repeated oral gavage 18 doses) of neonatal, juvenile, and adult rats with organophosphorus (OP) pesticides. The exact mechanisms of this age­ dependent sensitivity are not known, but several studies have demonstrated that toxicokinetic factors may be responsible. Most notably, the more limited ability of the young to detoxify OP pesticides by A­ esterases and carboxylesterases appears to be an important factor underlying the increased sensitivity of the immature rat to ChE inhibition. There also appears to be more rapid recovery of inhibited AChE (synthesis of new ChE enzyme) in postnatal (and fetal) rat tissues, but information on comparative recovery in children and human adults is lacking. The Panel considered the Agency's summarization of the current literature to be adequate in some areas and deficient in others. The discussion and summation of the age­ dependent toxicity of the six OP insecticides for which data are available was concise and complete, and Tables 1 and 2 were helpful and informative. Toxicokinetic factors were proposed to be critically important in age­ related sensitivity and limited discussion was provided in the document on the detoxifying esterases (carboxylesterase and A­ esterase) and their differential expression during maturation. However, little is mentioned regarding differences in oxidative metabolism and its potential role in differential sensitivity via differential rates of metabolism of some OPs to more active forms. The report documented the role of A and B esterases in the limitation of AChE inhibitor action and the importance of AChE resynthesis as a means of differential recovery from enzyme inhibition. However, the discussion of the biological factors [specifically, A­ esterases and carboxylesterases] that might result in age­ dependent susceptibility to toxicity of certain OPs could be significantly improved by presenting a more balanced interpretation of the available data. Some anticholinesterases show distinct age­ related differences in effects, while other OP agents appear to express little age­ related differences. Differences in sensitivity tend to be smaller with repeated dosing and may also be a function of age of the developing animal. Several factors may contribute to this finding, including faster recovery of acetylcholinesterase in tissues of young animals and increasing levels of detoxifying esterases with increasing maturity of metabolic systems. Several studies have shown that the sensitivity of the target enzyme in tissues from different age groups does not differ. Thus, sensitivity of acetylcholinesterase molecules themselves probably does not contribute to age­ related sensitivity. Differences in cholinergic receptor adaptation were also considered. Cholinergic receptors often downregulate following cholinesterase inhibition, but differences in receptor adaptation do not appear responsible for agerelated sensitivity. The Agency's background document also mentions the presence of muscarinic autoreceptors, capable of inhibiting acetylcholine release presynaptically. In fact, the postnatal maturation of the muscarinic autoreceptor correlates roughly with decreasing acute sensitivity to OP toxicants and may therefore play a role in age­ related sensitivity. The Agency's background document summarized evidence that supports important roles for A­ esterases and carboxylesterases in the increased sensitivity of the immature rat, but ignores observations or interpretations that might suggest other possibilities. Consequently the document tends to overstate the degree to which the mechanisms of age­ dependent toxicity of OPs are understood. This is most apparent with regard to three issues: 19 1. The document summarizes several studies that have reported correlation between the temporal patterns of development of A­ esterase and carboxylesterase activities and OP sensitivity. However, the document does not mention that some of those studies also have reported a decreased capacity of immature rats to oxidatively activate these same insecticides. Immature rats have reduced A­ esterase and carboxylesterase activities, but they also have a similarly reduced capacity to produce the oxygen analogs from the parent insecticides. This is an important potentially offsetting observation that should be discussed in the report. It should be noted that no targeted mechanistic studies have evaluated the role of these esterases in age­ related sensitivity. Thus, only a correlation between inherent esterase activity levels and sensitivity to the anticholinesterases support the concept of esterase­ mediated differential sensitivity. 2. The report presents evidence in support of a role for A­ esterase in detoxification of certain OPs and in age­ dependent sensitivity, but does not discuss evidence that might be contrary to this view. There are only three oxons that have been identified that are substrates for A­ esterase in vitro – paraoxon, chlorpyrifos oxon, and diazoxon. Studies with knockout mice have indicated that paraoxon metabolism by A­ esterase is probably insignificant in vivo. And as indicated in the document, knockout mice were much more sensitive to chlorpyrifos oxon or diazoxon. However, not mentioned in the document was the observation that knockout mice were only slightly more sensitive to the parent compounds chlorpyrifos and diazinon, and even then only at high doses, suggesting that A­ esterase may not be an important detoxification pathway upon exposure to the parent insecticides. In addition, some reports in the literature have suggested that A­ esterase in the rat probably only plays a role in detoxification when the chlorpyrifos or diazinon doses are very large. At small to moderate doses, detoxification by A­ esterase is probably insignificant compared to detoxification through carboxylesterase. The report should include some discussion of this issue. 3. The document, referring to Table 2 on p. 22, states that the temporal pattern of A­ esterase and carboxylesterase activities correlate reasonably well with studies on OP sensitivity. But it does not discuss possible exceptions to this correlation. For example, methyl paraoxon is not a substrate for A­ esterase, and has limited interactions with carboxylesterase. Therefore, one should expect limited age­ dependent sensitivity yet its acute age­ dependent sensitivity (from Table 1) is almost the same as that of chlorpyrifos, and its age­ dependent toxicity after repeated administration might even exceed that of chlorpyrifos (again from Table 1). These observations could suggest involvement of other factors in the age­ dependent sensitivity of at least methyl parathion. The discussion focused on developmental profiles of esterases exclusively and ignores changes in cytochrome P450 activities with age as a potential contributing toxicokinetic factor in agerelated sensitivity to OPs. The discussion should be expanded to include a description of the state of knowledge on P450 development in the rat, focusing primarily on isoforms known or suspected 20 to be involved with OP bioactivation and detoxification. The Agency needs to include a discussion in the background document on the implications of different possible dose metrics in explaining age­ related sensitivities through metabolism. There should be a clear articulation of reasonable alternative hypotheses about which dose metric( s) for ChE could be important for the developmental pharmacodynamic actions of anti­ cholinesterase agents. For example, it is possible that the best dose metric for predicting effects could be "peak" levels of cholinesterase inhibition on one day or several days of successive exposure. Alternatively, an "AUC" measure of the integral of % inhibition X time could prove to be the closest causally relevant predictor of developmental effects. There are also a few more complex hypotheses. In any event, given each of these and/ or other plausible measures of internal delivered "dose", a discussion should be included on the roles of activating vs. detoxifying enzyme activities and other factors in this context. As an example, for measures of acute peak cholinesterase inhibition by OPs requiring activation for biological activity, activating enzyme activities will be important and detoxifying enzymes such as the esterases will tend to be less important. The opposite would tend to be the case if AUC (integrated % inhibition X time) over an extended period of dosing is more important for causing developmental effects— in that case, activating activity would be somewhat less important and detoxifying enzyme activities for both the parent chemical and the activated intermediate would tend to be more important. Question 2.2 Please comment on the timing of administration (i. e., the developmental stage treated) and the differential found between adults and the young animal. The Panel interpreted the question as a query on the impact of dosing parameters on relative sensitivity of different age groups. The Panel concluded that the timing of exposures is critically important in evaluation of age­ related differences in sensitivity to anticholinesterases. The Agency's background document describes a number of studies, some with prenatal, some with postnatal, and some with combined prenatal/ postnatal exposures. Based on cholinesterase inhibition, the studies utilizing exclusively prenatal dosing appear to report consistently equal or lesser effects in the developing organism than in the dam. This may in some cases be due to the timing of biochemical measurements relative to exposure, but the findings generally suggest no higher sensitivity to cholinesterase inhibition in prenatally­ exposed animals. The reverse is often found when animals are exclusively treated postnatally. In essence, higher toxicity and more extensive cholinesterase inhibition are often noted in neonatal animals compared to older immature animals, and even greater differences in sensitivity arise when comparing very young animals to adults dosed similarly with a number of OP toxicants. With acute, relatively high exposures, several OP insecticides are markedly more toxic to very young individuals. This kind of stage­ related sensitivity is compound specific and it appears to be directly related to the maturational state of A­ esterases and carboxylesterases. Compounds that are not substrates for one or both of these developmentally regulated enzymes appear generally not to show differential inhibition based on timing of bolus injection. In some cases, however, age­ related sensitivity may 21 occur with OP toxicants that are not well detoxified by either carboxylesterase or A­ esterase (e. g., young animals are markedly more sensitive to methyl parathion). Other toxicokinetic or toxicodynamic factors may therefore play an important role in age­ related sensitivity. In contrast, when immature and adult rats were repeatedly exposed to some OP insecticides (e. g., chlorpyrifos), relatively little age­ related differences in cholinergic toxicity were noted. The ability to recover between exposures in tissues from younger animals may be important in this regard, i. e., if AChE molecules are being synthesized faster in immature animals, overall enzymatic activity will recover faster following each cholinesterase inhibitor exposure, thereby reducing accumulation of insult. Because of the relatively short maturation period in rodents, however, repeated dosing studies can change the baseline, i. e., the animal is becoming less sensitive to the pesticide throughout the dosing period. Thus, lesser age­ related differences in sensitivity with repeated, compared to acute exposures, may be due both to inherent differences in recovery potential and to decreased sensitivity as the dosing period progresses. One could question if changes in enzyme recovery may even cause a reversal of age­ related sensitivity in repeated dosing paradigms; that is a situation in which adults are more sensitive than younger animals. In fact, several studies (Chakraborti et al., 1993; Pope and Liu, 1997; Zheng et al., 2000) suggest that while neonatal rats are markedly more sensitive to acute exposures to chlorpyrifos, fewer differences are noted with daily dosing, and if intermittent dosing (every four days) is used, more extensive neurochemical changes (i. e., AChE inhibition, muscarinic receptor downregulation) may occur in adults. These findings imply that more rapid recovery of AChE activity noted in the immature animal's brain following OP exposure can in fact contribute to more rapid functional recovery of neurotransmission. Question 2.3 Please comment on the extent to which comparative ChE data on six OP pesticides (chlorpyrifos, diazinon, dimethoate, methamidophos, malathion, methyl parathion) may represent a reasonable subset of different structural and pharmacokinetic characteristics of the cumulative group of OP pesticides to define an upper bound on the differential sensitivity that may be expected at different life stages of the immature animal. As an example, there are no chemical­ specific comparative cholinesterase data on azinphosmethyl (AZM), an important contributor of risk for the food pathway. Pesticide­ specific comparative cholinesterase data on the other six pesticides from the OP class (including data on malathion, a member of the same chemical subgroup as AZM) show a limited range of differential sensitivities ­­ from one­ fold (no increased sensitivity) up to three­ fold between the young and adults. EPA regards these data on other OPs as providing sufficient evidence to assess the potential for AZM to show age­ dependent sensitivity, and to reasonably predict the degree of potential difference in sensitivity between the young and adults. Given the results of the other OPs, EPA concludes that it is unlikely that AZM would exceed a magnitude of difference greater than approximately 3­ fold following treatment of PND 11 through 21 pups versus adult animals. 22 The majority of the Panel members concluded that the comparative data on six OP pesticides (chlorpyrifos, diazinon, dimethoate, methamidophos, malathion, and methyl parathion) should not be considered to represent a reasonable subset of different structural and pharmacokinetic characteristics of the cumulative group of OP pesticides to define an upper bound on the differential sensitivity that may be expected at different life stages of the immature animal. However one Panelist dissented from this view, and agreed with the report that these six pesticides could be used to define an upper bound on the differential sensitivity for the cumulative group. Specific comments by Panelists against the use of the 6 OPs as a representative subset of the cumulative group were as follows: The currently available data on direct postnatal exposure of six OP pesticides shed some light on the potential differential sensitivity of OPs during stages of development. The Agency is to be commended for the extensive effort in addressing these rather complicated issues. However, the complex interplay of many factors (e. g., pharmacokinetics and pharmacodynamics that are chemical­ and developmental stage­ specific) leading up to the inhibition of brain ChE inhibition is the source of substantial uncertainty for predicting the upper bound of the differential sensitivity for all the OPs under evaluation. The document suggests that the age­ related change in sensitivity to certain OPs is largely a function of toxicokinetic factors since age­ related changes in acetylcholinesterase catalysis and sensitivity to inhibitors do not occur. If this is the case, one must consider whether or not the toxicokinetic characteristics of any remaining members of the cumulative assessment group are sufficiently different from the six indicated in the document, so as to lead to a juvenile/ adult differential toxicity greater than a 3­ fold uncertainty factor. Based on the lack of information in the open literature regarding the toxicokinetic characteristics of the remaining pesticides (most importantly their metabolism and volumes of distribution), one must conclude that there simply is not enough information available to know whether or not the six insecticides indicated in the document are representative toxicokinetically of the cumulative group. Consequently, we do not know if those six OPs can define an upper bound for the possible differential age­ dependent sensitivity of other OPs. One Panelist offered differences in potency among ChE agents as an illustration of the uncertainties involved in extrapolating biological properties between agents. A more that 10­ fold difference in the relative potency factor (RPF) is observed between the metabolic activation pair of acephate and methamidophos, just within adult female rats. For these two chemicals, and with the rich database available for methamidophos, the Agency's document stated that it is not possible to determine "whether acephate would show comparable responses in adult and young rats" (page 13, Determination of the Appropriate FQPA Safety Factor( s) in the Organophosphorus Pesticide Cumulative Risk Assessment; June 10, 2002). Other than obtaining chemical­ specific data, much more information is needed for a reliable estimate of a range of agerelated sensitivity of OPs. There are insufficient data to fully support a 3­ fold uncertainty factor 23 based on an estimated upper bound of 3­ fold age­ related differential sensitivity. It should also be noted that dose­ response modeling would give a more consistent comparison for the age­ related sensitivity among chemicals, and the Agency's analysis showed that the upper bound would be 4­ fold based on data for methyl parathion. Presumably this is only based on the data from repeated dosing, and not including the single dosing study that showed up to 7­ fold differences. Thus, given the current data, it may be prudent to consider an upper bound of greater than 3 just for the toxicity side of the uncertainty factor consideration. Overall, it is ill­ advised to speak of an "upper bound" from the six available observations in this case. "Upper bound" conveys the impression of a firm, known upper limit and the existing data cannot support a conclusion of this sort with any reasonable degree of confidence. It is even challenging to attempt a distributional treatment from such a small number of chemicals but this is the best treatment that can be made. A first step should be to apply either the Agency's exponential model as presented at the February 2002 SAP meeting, or, where the data are insufficient for this, a simplified version of it to express the apparent relative potency based on estimated ED10's of the chemicals for either acute or repeated dosing exposures for animals of various young age groups versus adults. The simplified exponential model is needed because some of the current calculations distort the relative potency of the cholinesterase inhibition results in young versus adult animals by failing to take into account the fact that no more than 100% of the enzyme can be inhibited. For example, the calculation from the Moser et al acute dosing data for male animals is based on a simple ratio of 89% inhibition in pups versus 39% inhibition in adults. Clearly, with a simple ratio, even if the true potency ratio in the two groups were 100 or 1000, the calculation could not produce a result larger than 100/ 39 or approximately 2.5. The 2. 3 in the document becomes about 5 when one applies a simple one­ parameter version of the exponential model. One Panelist suggested a revised experimental model, as presented by the Agency, that uses a basic exponential form, but omits the high dose saturation level of inhibition and the expanded model's low dose nonlinearity feature: Fraction inhibited = 1 – e ­kd (1) Where d is the dose and k is the measure of potency (inhibition units per dose at low doses). This model at least corrects for the fact that one cannot get more than 100% inhibition while calculating apparent potency in each group. Using this simplified exponential model, the relative potency for two comparable experiments in animals of different age is just the ratio of k1 for the younger age group to k2 for the older/ adult age group, or: Potency in young age group relative to adults (k1/ k2)= 24 d 2 (adult animals) ln (1 ­ Fraction inhibited in young) d 1 (young animals) ln( 1 ­ Fraction inhibited in adults) (Alternatively, one could use equation 1 to estimate ED10's for each group and take a ratio of the ED10's as the measure of relative potency. The results of this would be very similar to the ratio of "k" potency factors described above). This equation for relative potency in adult and young animals incorporates a saturation at 100% cholinesterase inhibition and also corrects for the situation where the inhibition findings are from different doses. Putting in an upper limit of inhibition short of 100% (as is found necessary in some cases in the Agency's modeling) would tend to increase the pup/ adult sensitivity ratios in cases where the pup shows greater inhibition than the adult. A particular challenge for this proposed analysis applies to cases such as malathion where in some cases there is no detectable cholinesterase inhibition in adult animals at rather high doses, but there is appreciable inhibition at comparable and lower doses in younger animals. Simply excluding these cases risks biasing the analysis, so some truncated distributional analysis is needed here. Other specific comments offered by one Panelist in support of the use of the 6 OPs as a representative subgroup of the cumulative risk were as follows: First, there is no inherent difference in the ChE enzymes or its binding to an OP between young and adult animals. Second, the difference between inhibition of ChE between newborn, pups and adult animals is primarily due to two factors, which are the rate of regeneration of the enzyme and the level of various enzymes, such as the esterases and others, that detoxify the OP, neither of which will be different among the compounds that are tested. The main difference among the test compounds is going to be the relative rate of detoxification. In general, the 6 OPs for which data are available for ChE inhibition of young and adult animals are qualitatively similar with respect to ChE inhibition. For these compounds, the ratio of ChE inhibition of adult to pup sensitivity ranged from no difference to three fold. Based on this information, the Agency has included a 3­ fold uncertainty factor. The 3­ fold factor is reasonable since the range of 1 to 3 fold is based on dosing of large amounts of OPs directly to the pup and adult animals, which represents exaggerated exposure conditions. Under more realistic conditions of exposure to pregnant or lactating dams, the degree of inhibition in the neonates and the pups was generally less than the dam. Overall, the prediction of the range of enzyme inhibition is more limited than the prediction of toxicity and the lack of information for the other OPs and the uncertainty in making 25 this estimate is taken into account by the incorporation of a 3­ fold uncertainty factor. Issue 3. Relevance of the Animal Findings to Children Age dependent sensitivity to cholinesterase inhibition has been associated with the limited ability of the immature rat to detoxify OP pesticides by esterases. In rats, Aesterase activity increases from birth to reach adult levels around postnatal day 21. Fetal rats possess very little carboxylesterase activity with increasing activity as the postnatal rat matures, reaching adult values after puberty (50 days of age). Data showing increased sensitivity of the young animal to cholinesterase inhibition compared to adults has generally been derived from acute dosing of PND 7 or PND 11 pups, or repeated dosing of PND 11 to PND 21 pups. The available data also show as the young rat rapidly matures in its ability to detoxify by esterases, the differential in cholinesterase inhibition becomes smaller. Thus, the relative sensitivities of immature rats found in the studies of dosing pups through PND 11 to 21 are smaller compared to studies of dosing a PND 11 pup. The dosing studies of PND 11 through 21 pups are considered to better approximate the maturation profile of the A­ esterases of the highly exposed children's age group in the OP cumulative risk assessment, the one and two year olds, compared to a study of a PND 11 pup which is similar to a newborn. Thus, the repeated rat dosing studies more closely mimic the maturation or developmental profile of A­ esterase appearance in children around the one and two year olds where children are reaching adult levels of A­ esterase activity. The use of dosing studies of PND 11 through 21 is consistent with the exposure patterns of children. Humans generally do not begin to consume fresh (uncooked) fruits and vegetables until after six months of age or more. Furthermore, repeated dosing studies were used to determine relative sensitivity because people are exposed every day to an OP pesticide through food, and thus an animal study using repeat exposures is considered appropriate. Finally, following exposure to an OP, regeneration of cholinesterase to preexposure levels does not occur for days or weeks, making the exposed individual potentially more vulnerable to subsequent exposures during that period. Question 3.1 Please comment on the maturation profile of A­ esterase and the uncertainties surrounding these data in young children. Because no human data are available on the maturation profile of carboxylesterases, please comment on what should be assumed in humans, especially children age 1 to 2 years, given the animal data and what science understands in general about detoxification maturation profiles. The Panel concluded that there is appreciable residual uncertainty about the differences in activity at early versus adult life stages in relevant activation and detoxification pathways in animals and humans, especially for detoxification by carboxylesterases. Many Panel members provided generally similar perspectives. The discussion below 26 begins with evaluations of the specific data cited in the Agency's background document for the changes in A­ esterase levels during development. With this as background, the Panel responded to the last part of the question with a review of the general profile of changes in whole­ body elimination half lives for drugs in general, and drugs eliminated by various specific pathways. In the absence of more direct evidence for developmental changes in carboxylesterases and other even less well characterized routes of elimination, these data provide the most applicable starting point for defining baseline expectations and associated uncertainties. Specific Data on Changes in A­ esterases and P450 Activating and Detoxifying Enzymes During Development It would be useful to include more information in the Agency's background document on metabolic enzymes and metabolism since the rate of detoxification appears to contribute to the differences in the relative inhibition of ChE at various ages as compared to the adult in rats. Carboxylesterases and A­ esterases have been shown to be important in the detoxification of some OP toxicants in rats, and may contribute to age­ related differences in sensitivity in humans. However, some studies suggest that other metabolic factors may also be important contributors to age­ related sensitivity for other OP agents. The entire spectrum of enzymes responsible for activation/ detoxification of the OP toxicants should be evaluated for potential changes in enzyme expression and function during human development and their potential contributions to relative sensitivity. Determination of activities of all processes in human tissues would be ideal, but difficult to accomplish. Additionally, while the relative contributions of blood and tissue detoxification can be estimated in animal models, this information is unknown in humans for most if not all OP toxicants. This subject therefore represents a potentially significant uncertainty in how young children may respond to OP toxicants relative to adults based on differential metabolism. Both the carboxyesterases and A­ esterase are non­ specific esterases. Data are available concerning changes in the levels of A­ esterase in blood with age in humans, which are about 20 % of adult levels at birth and near adult levels by 6 months of age; however, there are fewer data for the carboxylesterases during development. Several Panel members felt that data should be collected at least with blood carboxylesterases to limit the uncertainty associated with that missing information. There is a complete lack of data about the activity levels of these esterases in the liver and other tissues where the bulk of the detoxification is likely to occur. At birth, the esterases in general, like many other enzymes responsible for metabolism, are at a low level— approximately 20% of adult values. These enzymes increase rapidly during the first few months and although variable, are near the adult level (60­ 70%) at six months. The fact that the OP exposure of very young infants is estimated to be smaller than that of other age groups tends to reduce concerns arising from neonatal deficiencies in esterases that detoxify OPs. One Panel member noted that the development of the various esterases appears to be generally similar and the carboxyesterases are likely to be similar to the A­ esterases in this regard. Some Panel members felt strongly that EPA should not accept the remaining data gaps on the relative importance of different esterases for detoxification of different OPs for any length of 27 time. Now that EPA research scientists have developed an in­ house assay that at least approximately tracks the age dependent shift in blood samples' ability to alter OP availability in vitro based on A­ esterase and carboxylesterase activities, these assays should be performed with human blood samples at all ages of interest and with all environmentally relevant OPs. The problem with carboxylesterase is that human blood contains very little of this enzyme, which is largely confined to liver. Therefore, for the foreseeable future, the Agency must continue to reason by analogy with animal data and with the developmental profile of other liver drug metabolizing enzymes. In this context, however, it does appear reasonable to assume that the youngest infants will indeed be deficient in carboxylesterase expression, and that expression of this enzyme will approach adult levels sometime in early childhood— possibly in the 1­ 2 year bracket. Some OPs are initially metabolized by cytochrome P450s to oxon intermediates. It appears that the P450s involved are P450 3a and 2D6 families. Cytochrome P4502 D6 expression is decreased in the newborn's liver and then approaches the adult level within a few weeks. Family 3 enzyme overall activity is generally thought to be increased during the newborn, infancy and early childhood stages of life. Family 3a during development is primarily composed of P4503a4 and 3a7. P4503a7 is the fetal form of family 3a and is expressed in high levels in the fetal, newborn and infant liver as compared to the adult. The P450 3a4 is expressed at higher activity levels during these periods than in adulthood. These findings are somewhat substrate dependent and to the Panel's knowledge, studies of the capacity of 3a7 to metabolize OPs have not been conducted. The changing expression of these P450 forms may add to the overall toxicities of the OPs to the human during development. The expression of these enzymes in the human brain during development has not yet been extensively studied. Detoxification Maturation Profiles Overall, the pattern of age­ related change in the A­ esterase bears a close resemblance to general patterns of change for elimination inferred from human observations of age­ related changes in the pharmacokinetics of therapeutic drugs. Table 1 reproduces the results of an analysis by Hattis et al. (2002, in press) and Ginsberg et al. (2002). The table shows geometric means ± 1 standard error range of the ratios of the half lives of drugs eliminated by a variety of pathways in children of various age groups relative to adult half lives. Overall, premature infants show on average about a four­ fold prolongation of elimination half life for the typical drug; and infants under 2 months of age have about double the half life of adults. The 6 month to 2 year age group shows, if anything, a slightly shorter geometric mean half life than in comparable adult studies. If these patterns hold for activation and inactivation pathways for OPs, then agents that do not require metabolic activation would be expected to pose greater risks in very young full term infants (achieving comparable blood levels at about half the long term internal dose per mg/ kg of external dose) but children in other age groups would, on average show no greater pharmacokinetic sensitivity than adults. Other things being equal, it seems most likely that the unmeasured carboxylesterase will behave similarly, but how confident one should be about this is open to question. 28 A further topic where data are available is the extent of human inter­ individual variability in half lives as a function of age. Variability is much larger than adults in the age groups up until about six months, but reverts approximately to adult levels of pharmacokinetic variability thereafter. 29 Table I. Geometric Mean Ratios of Child/ Adult Elimination Half­ Lives. Data Represent Regression Results from 135 Data Groups for 41 Drugs, Log( Arithmetic Mean Half­ Life) Data Major Elimination Pathway Premature neonates Full term neonates 1 wk­ 2 mo 2­6 mo 6 mo­2 yr 2­ 12 yr 12 ­18yr All pathways 3. 89 (2.8­ 5.4) a 1.96 (1.7­ 2.3) 1.93 (1.7­ 2.2) 1.17 (1.0­ 1.3) 0.79 (0.66­ 0.94) 0.98 (0.89­ 1.1) 1.11 (0.86­ 1.4) All CYP (P450 metabolism) 4.52 (2.5­ 8.0) 1.83 (1.4­ 2.3) 3.51 (3.1­ 4.0) 1.22 (0.96­ 1.6) 0.51 (0.41­ 0.65) 0.61 (0.52­ 0.72) 0.73 (0.26­ 2.0) All Non­ CYP 3. 43 (2.4­ 4.8) 1.80 (1.5­ 2.1) 1.46 (1.3­ 1.7) 1.06 (0.91­ 1.2) 0.98 (0.78­ 1.2) 0.92 (0.81­ 1.03) 1.11 (0.87­ 1.4) Unclassified 1. 00 (0.83­ 1.2) 0.94 (0.94­ 1.06) more detailed classification: CYP1A2 2.74 (0.9­ 7.6) 9.45 (2.9­ 31) 4.29 (3.8­ 4.9) 1.24 (1.0­ 1.5) 0.57 (0.44­ 0.72) 0.54 (0.45­ 0.64) Renal 2. 78 (1.4­ 5.4) 2.75 (1.8­ 4.1) 1.15 (0.86­ 1.6) 0.81 (0.60­ 1.1) 0.60 (0.48­ 0.74) 1.13 (0.73­ 1.7) Glucuronidation 4. 40 (4.1­ 4.7) 2.98 (2.8­ 3.2) 2.15 (1.7­ 2.7) 0.98 (0.84­ 1.1) 1.19 (1.0­ 1.4) 1.36 (1.2­ 1.5) 1.47 (1.3­ 1.7) CYP3A 5. 28 (2.7­ 10) 2.08 (1.4­ 3.2) 1.91 (1.5­ 2.5) 0.41 (0.27­ 0.63) 0.61 (0.45­ 0.84) 0.73 (0.25­ 2.1) CYP2C9 2. 19 (1.7­ 2.8) 0.55 (0.39­ 0.79) 0.77 (0.51­ 1.2) Other, mixed CYP's 1. 27 (0.7­ 2.3) 1.08 (0.58­ 2.0) Other Non­ CYP's (not renal, glucuronidation) 0.41 (. 03­ 5) 1.22 (0.94­ 1.6) 1.05 (0.80­ 1.4) 0.77 (0.58­ 1.0) 1.24 (0.94­ 1.6) 1.41 (0.82­ 2.4) a Parentheses show the ± 1 standard error range. 30 Question 3.2 Please comment on the extent to which the biological understanding of observed age­ dependent sensitivity to cholinesterase inhibition in laboratory animal studies informs our understanding about the likelihood of similar effects occurring in children; in particular, what can be inferred from animal and human information regarding the potential for different age groups to show increased sensitivity if exposed to cholinesteraseinhibiting pesticides. Does the scientific evidence support the conclusion that infants and children are potentially more sensitive to organophosphorus cholinesterase inhibitors? The scientific evidence supports the conclusion that infants and children are potentially more sensitive to OP cholinesterase inhibitors than are adults. There are still important unresolved questions including: 1) What is the extent of age­ dependency in human fetuses, children, juveniles, adults (and the elderly) and is it larger or smaller than in rats? 2) What are the ages at which higher sensitivity is present in humans as compared with rats (e. g., are 1­ 2 yr. humans best modeled by the PND 21 rat)? 3) Are underlying mechanisms contributing to agerelated sensitivity fundamentally similar? and 4) Does a certain degree of acetylcholinesterase inhibition in the immature system leads to equivalent neurochemical consequences as those observed in adults ­ or, by contrast, are there likely to be some adverse neurodevelopmental consequences for amounts of brain cholinesterase inhibition that are considered reasonably tolerable by adults? The understanding of differential age­ related toxicity in experimental animals exposed to OP toxicants suggests that, with acute high exposures, young children may be markedly more sensitive to some agents. This is likely based on both toxicodynamic and toxicokinetic factors including differences in expression of detoxifying esterases, possible differences in activation of some agents, and in maturation of adaptive processes that limit or modulate anticholinesterase toxicity. With other OP toxicants (e. g., methamidophos), lesser or even no age­ related differences in acute sensitivity may exist. Some studies suggest, however, that differences in sensitivity are less pronounced or non­ existent with repeated dosing. Both kinetic (e. g., detoxification) and dynamic (e. g., feedback inhibition of acetylcholine release) pathways are most likely important in contributing to age­ related differences in sensitivity to high dose exposures, i. e., these processes are likely challenged only when high levels of the toxicant occur in the system. Thus, with repeated, lower exposures, lesser differences in sensitivity would be expected. As noted above, however, it is likely that the reduced age­ related differences with repeated exposures in rodents is due to rapid maturation of the animal with consequent decreased sensitivity over the course of exposure. Therefore, the Panel agreed that the scientific evidence supports the conclusion that infants and children are potentially more sensitive to OP cholinesterase inhibitors to acute high dose exposures. With lower and repeated exposures, the evidence for higher sensitivity in young individuals is not as convincing. In the absence of directly applicable data, it was felt that humans might differ from rats in 31 the extent and nature of age­ dependent sensitivity for enzyme inhibition. All the animal data were generated using either direct exposure to neonates, juvenile and adult animals at very high doses or the treatment of pregnant or lactating animals, also at relatively high dose levels. The data from the repeated direct dosing experiments yielded ChE inhibition sensitivity ratios of 1 to 3­ fold for pups versus the adults. This could become as much as 10­ fold following acute dosing. Whether this makes a substantial difference in humans likely depends on the exposure level. As stated above, the remaining data gap regarding human blood A­ esterase­ mediated detoxification of the different OP anticholinesterases should be addressed by further research. A number of experimental approaches were proposed by Panel members. One was the use of an in vitro model recently developed (Padilla et al., 2002). Now that EPA scientists have developed an in­ house assay that at least approximately (and perhaps quite accurately) tracks the age dependent shift in blood esterase abilities to alter OP availability in vitro, as a direct comparison between species, these assays should be run with human and rat blood samples at all ages of interest and with all environmentally relevant OPs. For carboxylesterase, a complication exists for projection between species, i. e., in humans (in contrast to rodents), very little of this enzyme is found in the blood. One Panel member recommended a set of studies on the age­ related variation in sensitivity of blood cholinesterases to inhibition by OP inhibitors in a primate model, preferably a higher primate. An advantage of a primate model is the similarity in plasma carboxylesterase activity, i. e., primates are deficient in this pathway. Such studies would provide the most relevant possible animal data on several fronts, including the difficult question of whether AChE and BChE resynthesis is indeed faster in young children than in adults, and at what developmental stage. They would also provide information on the potential importance of carboxylesterases and Aesterases at different ages. In the foreseeable future, however, we must continue to reason by analogy with rodent data and with the developmental profile of other liver drug metabolizing enzymes. In this context, it does appear reasonable to assume that the youngest infants will indeed be deficient in tissue carboxylesterase expression, and that expression of this enzyme will approach adult levels sometime in early childhood— probably in the 1­ 2 year bracket or sooner. Two Panel members felt strongly that the studies presented by the Agency have limited application to understanding the effects of OP insecticides, specifically in children. While adverse effects related to mechanisms other than acetylcholinesterase inhibition are considered in the risk assessment for individual OP agents, there is concern that such possible effects could be "hidden" in the process of cumulative risk assessment. The evaluation of OP toxicity can be considered to belong in the realms of behavioral teratology and toxicology. James Wilson, who opened this field, delineated dose­ response relationships of prenatal toxicants. At highest exposures, the outcome is fetal death; at somewhat lower doses, congenital defects; at lesser doses, growth retardation is seen; and finally, at the lowest exposures, functional deficits, most notably behavior, become visible. It is in this lowest exposure stratum that examination of OP toxicity should continue. The concern with the effects of OPs prenatally and postnatally is associated with the brain. This relates to the impact of OPs on children's function, and among their most critical functions is their ability to think, talk and pay attention. Not to include data on these outcomes excludes important variables in the assessment and therefore introduces important specification 32 error. Wilson's work and the work of many others have shown that systematically measured behavior may demonstrate toxicological effects at lower doses than those that yield phenotypic or biochemical alterations. These same Panel members further stated that EPA­ listed studies of animal behavioral effects, some of which were not associated with cholinergic alterations, were conducted at doses of OP pesticides previously thought to be without effect. Levin and colleagues reported long term behavioral changes in offspring following maternal chlorpyrifos exposure. The nature of the changes (loss of sensitivity to cholinergic muscarinic antagonist) suggested that the behavioral effects were not cholinergic in origin. These and other data point to mechanisms besides AChE inhibition that may also be at work in OP toxicity. Thus, reliance on a single biochemical assay to measure brain damage may become problematic. Expanding on this issue, the Panel members pointed out that when using a marker, in this case brain AChE levels as a marker for more proximate effects of OPs, one is required to calibrate it and determine its validity in estimating the process or event that it stands for. To determine this, it is necessary to measure both the marker and the process of interest (e. g., synaptogenesis, behavioral outcome) and determine the correlation between the two variates, the coefficient of determination, the sensitivity, specificity, and predictive power, both positive and negative, of the marker. These factors have precise meanings in science. Sensitivity is the probability that an outcome (e. g., impaired learning) will be identified by the marker. Specificity is the probability that the absence of such an outcome will be correctly identified. Predictive power positive is the probability that a positive test will identify a specified outcome. EPA has not indicated anywhere in its report that these important determinations have been accomplished. As a consequence, the amount of measurement error in the cumulative risk assessment is unknown. Since this measurement error is nonsystematic (neither systematically higher or lower AChE levels than the true values) and non­ differential (not increased in subjects with higher brain AChE, etc., than with lower levels), the direction of the bias introduced by measurement error is toward the null. That is, it would tend to underestimate the size of the effect under study, in this case the sensitivity of children to OPs. From these points, these Panel members concluded that the EPA report contains substantial measurement and specification errors, and as a consequence, underestimates the risk of OPs for child health. In general, however, it should be stressed that the cumulative risk assessment for the OP insecticides is indeed based on acetylcholinesterase inhibition and cholinergic toxicity. While noncholinergic endpoints may weigh on the risk assessment of individual agents, the cumulative risk assessment is driven by cholinergic mechanisms initiated by acetylcholinesterase inhibition and related to consequent increases in acetylcholine, if the common mechanism for OP insecticides is acetylcholinesterase inhibition and cholinergic toxicity. Based on this endpoint, there is compelling evidence to support the conclusion of potentially higher sensitivity in infants and children. Question 3.3 33 Please comment on the conclusions regarding the faster recovery in the young animal of AChE activity. Because there is no human information on the recovery of AChE in children compared to adults, please comment on the extent to which recovery of AChE in children should be factored into conclusions regarding potential risk to children. The Panel agreed that given the conservation of neurodevelopmental processes across species, all aspects of this biological process identified to be critical in the rodent model should be taken into consideration when evaluating these compounds for their potential risk to children. The Panel raised some issues regarding the interpretation of the biological consequences of the apparent faster recovery of AChE activity in the young animals – that is the Panel had reservations about whether the faster recovery could be regarded as indicating a return to a completely normal state that is free of further neurodevelopmental consequences. The Agency's background document provides information regarding what appears to be a faster recovery of AChE in young animals as compared to the adult. The available data are quite limited, however, and it is not possible to reach a conclusion regarding the dynamics of the underlying mechanisms of how this phenomenon occurs and its biological impact. Given the species conservation of many such biological processes, as well as the high degree of structural and functional homology between AChEs and ACh receptors in rats and humans, differential recovery rates should ultimately be factored into conclusions regarding possible risk to children. How this will be done in the absence of biological data is a question. The general mechanism proposed for differential recovery rates deals with higher on­ going macromolecular synthesis in immature tissues than adult tissue. There may also be differences in the ability of tissues to respond to AChE inhibition by inducing the synthesis of AChE. For example, some studies suggest that anticholinesterases can activate the transcription of AChE (Soreq and Seidman, 2001). These phenomena however, have not been adequately evaluated in animal models following OP exposure. In order to fully appreciate the importance compensatory mechanisms in the younger animal, information is needed on relevant transmitter systems including synthesis rates, turnover rates, and equilibrium levels of the transmitters, as well as the pharmacology, numbers and binding capacities of the transmitter receptors. Finally, we need to know much more about the down stream effects of increased acetylcholine levels resulting from an inhibition of AChE. Once this is known, we will have a better idea of exactly what the inhibition of AChE activity and its time to recovery may mean in the young animal. The compensatory ability of the developing animal also shows itself in the relatively normal phenotypes seen with certain knockout animals and genetic mutants. One might take comfort in reasoning that adaptive mechanisms seen in experimental animal models are also likely to operate in humans. A strong caution needs to be raised, however, because compensatory and adaptive mechanisms can still lead to permanently abnormal outcomes. Recovery of whole brain 34 AChE does not necessarily imply return to a normal state, especially in the developing nervous system. That is because the formation of brain architecture and the elaboration and stabilization of synapses must continue during the period of neurochemical disruption. The possible result is a permanent alteration in the characteristics of synapses formed in the interval prior to, during, and following exposure. In addition, the replenishment of AChE may merely reflect synthesis of catalytically active but functionally deficient molecules, with regard to cholinergic neurotransmission. As noted previously, however, when exposure periods are separated in time (4 day intervals between exposures), adult rats show more cumulative AChE inhibition and downregulation of receptors (Chakraborti et al., 1993). These findings suggest that the more robust recovery of AChE in immature animals indeed represents enhanced functional recovery. The major AChE expressed in nervous tissue is the so­ called "synaptic" form (AChE­ S). Chronic inhibition of AChE activity can lead to the expression of a unique transcript, referred to as the "read­ through" form (AChE­ R) that is secreted as a monomer (Grisaru, et al., 1999; Soreq and Seidman, 2001). This protein has the same enzyme kinetics as the synaptic form, and thus would appear in an enzyme assay as normal AChE. However, because the enzyme has a different distribution, it may not have the same functional impact as the normal AChE­ S. The relevance of these findings to the issue currently under review remains to be determined, yet they raise concerns regarding the dynamics of the overall process of cholinesterase inhibition during development. With all of these biological processes, the consequences of such inhibition and replenishment would depend upon the stage of brain development occurring during this period. ADDITIONAL COMMENTS One Panel member provided comments on the exposure assessment for consideration in the selection of an appropriate FQPA uncertainty factor. This Panel member analyzed the EPA's treatment of exposures (e. g. dietary exposure). References in the document to 95 th ,99 th , 99.5th, 99. 9th percentiles imply a view that such numbers bracket the high end exposures. A simple calculation of the corresponding consumption would show otherwise. This point can be illustrated by using the Agency's cumulative exposure for individuals 1­ 2 years old and assuming thatthe entire amountofexposure comesfroma single chemicalina single foodformofa commodity. For example, let's assume that the entire exposure is from azinphos methyl (AZM) in fresh apple or pear. The 1999 PDP single serving monitoring data showed that AZM was detected in 76.2% (1088 of 1427 samples) of apples at 0.01­ 0.55 ppm, and 43.2% (152 of 352 samples) of pears at 0. 013­ 0.87 ppm. Taking into account the 0.1 of RPF for AZM, and using the highest detected residue (0. 55 ppm for apple or 0. 87 ppm for pears), the cumulative dietary exposure of 0.0002 mg/ kg/ day at the 95 th percentile is equivalent to the consumption of either 1.3­ 1.9 oz. of apple or 0. 8­ 1. 2 oz. of pears. These levels of consumption do not appear to represent the high end of consumption even from just fresh apple or pears. Only as the cumulative exposure moves toward the higher distributional percentiles does it begin to appear more unlikely to be contributed from a single source. 35 This type of analysis is helpful to provide a context for exposure estimates in a cumulative risk assessment. Obviously, to choose an uncertainty factor to account for the exposure component we must know what percentile captures the reasonably expected high end. In this illustration, an argument can be made for an additional FQPA uncertainty factor if the benchmark for risk management decision is based on the 95 th percentile of dietary exposure. Fortunately, for the exposure assessment, especially the dietary route, sufficient data are available for a much more informed decision. The Agency is encouraged to provide documentation that goes beyond the numerical exposure values and percentiles present in the Agency's background document. REFERENCES Bigbee, J. W., K. V. Sharma, E­ L. Chan and O. Bogler. 2000. Evidence for the direct role of acetylcholinesterase in neurite outgrowth in primary dorsal root ganglion neurons. Brain Res., 861: 354­ 362. Bigbee, J. W., K. V. Sharma, J. J. Gupta and J. L. Dupree. 1999. Morphogenic role for acetylcholinesterase in axonal outgrowth during neural development. Env., Health Perspect., 107( Suppl 1): 81­ 87. Brimijoin, S. and C. Koenigsberger. 1999. Cholinesterases in neural development: new findings and toxicological implications. Environ. Health Perspect., 107( Suppl 1): 59­ 64. Chakraborti, T. K., J. D. Farrar and C. N. Pope. (1993). Comparative neurochemical and neurobehavioral effects of repeated chlorpyrifos exposures in young and adult rats. Pharmacol. Biochem. Behav. 46: 219­ 224. Coronas, V., M. Durand, J. G. Chabot, F. Jourdan, R. Quirion. 2000. Acetylcholine induces neuritic outgrowth in rat primary olfactory bulb cultures. Neurosci., 98: 213­ 219. Drews, U. 1975. Cholinesterase in embryonic development. Prog. Histochem. Cytochem., 7: 1­ 52. Dupree, J. L and J. W. Bigbee. 1994. Retardation of neurite outgrowth and cytoskeletal changes accompany acetylcholinesterase inhibitor treatment in cultured rat dorsal root ganglion neurons. J. Neurosci. Res., 39: 567­ 575. Eskenazi, B. A., A. Boardman and R. Castorina. 1999. Exposure of children to organophosphate pesticides and their potential adverse health affects. Env. Health Perspective, 107, (suppl. 3) 409­ 419. Ginsberg, G., Hattis, D., Sonawane, B., Russ, A., Banati, P., Kozlak, M., Smolenski, S., and Goble, R. (2002) "Evaluation of Child/ Adult Pharmacokinetic Differences from a Database derived from the Therapeutic Drug Literature," Toxicological Sciences, Vol. 66, pp. 185­ 200. 36 Grisaru, D., M. Sternfeld, A. Eldor, D. Glick and H. Soreq. 1999. Structural roles of acetylcholinesterase variants in biology and pathology. Eur. J. Biochem., 264: 672­ 686. Hattis, D., Ginsberg, G, Sonawane, B., Smolenski, S., Russ, A., Kozlak, M, and Goble, R. (2002, in press) "Differences in Pharmacokinetics Between Children and Adults— II. Children's Variability in Drug Elimination Half­ Lives and in Some Parameters Needed for PhysiologicallyBased Pharmacokinetic Modeling," Risk Analysis. Koenigsberger, C., S. Chiappa and S. Brimijoin. 1997. Neurite differentiation is modulated in neuroblastoma cells engineered for altered acetylcholinesterase expression. J. Neurochem., 69: 1398­ 1397. Layer, P. G. and E. Willbold. 1995. Novel functions of cholinesterases in development, physiology and disease. Progr. Histochem. Cytochem., 29: 1­ 94. Layer, P. G., T. Weikert and R. Alber. 1993. Cholinesterases regulate neurite growth of chick nerve cells in vitro by means of a non­ enzymatic mechanism. Cell Tiss. Res., 273: 219­ 226. Mesulam, M. M., A. Guillozat, P. Shaw, A. Levey, E. G. Duysen and O. Lockridge. 2002. Acetylcholinesterase knockouts establish central cholinergic pathways and can use butyrylcholinesterase to hydrolyze acetylcholine. Neurosci., 110: 627­ 639. Pope, C. N. and Liu, J. (1997). Age­ related differences in sensitivity to organophosphorus pesticides. Environ. Toxicol. Pharmacol. 4: 309­ 314. Sharma, K. V. and J. W. Bigbee. 1998. Acetylcholinesterase antibody treatment results in neurite detachment and reduced outgrowth from cultured neurons: further evidence for a cell adhesive role for neuronal AChE. J. Neurosci. Res., 53: 454­ 461. Soreq, H. and S. Seidman. 2001. Acetylcholinesterase – New roles for an old actor. Nature Neuroscience, 2: 8­ 16. Sternfeld, M., G­ L. Ming, H­ J. Song, K. Sela, R. Timberg, M­ M. Poo and H. Soreq. 1998. Acetylcholinesterase enhances neurite growth and synapse development through alternative contributions of its hydrolytic capacity, core protein and variable C­ termini. J. Neurosci., 18: 1240­ 1249. Wessler, I., C. J. Kirkpatrick and K. Racke. 1998. Non­ neuronal acetylcholine, a locally acting molecule, widely distributed in biological systems: Expression and function in humans. Pharmacol. Ther., 77: 59­ 79. Xie, W., J. A. Stribley, A. Chatonnet, P. J. Wilder, A. Rizziono, R. D. McComb, P. Taylor, S. H. Hinrichs and O. Lockridge. 2000. Postnatal developmental delay and supersensitivity to 37 organophosphate in gene­ targeted mice lacking acetylcholinesterase. J. Pharm. Exp. Therap., 293: 896­ 902. Zheng, Q., Won, Y., Olivier, K. and Pope, C. (2000). Comparative cholinergic neurotoxicity of oral chlorpyrifos exposures in preweanling and adult rats. Toxicological Sci. 55: 124­ 132.

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regulations

EPA-HQ-OPP-2002-0084-0002

Notice

Pesticides; Draft Guidance for Pesticide Registrants on False or Misleading Pesticide Product Brand Names; Extension of Comment Period.

48469 Federal Register / Vol. 67, No. 142 / Wednesday, July 24, 2002 / Notices and intermediate dermal toxicity studies with rats, EPA has determined that an added FQPA safety factor of 3x is appropriate of assessing the risk of glufosinate­ ammonium derived residues in crop commodities. Using the conservative assumptions described in the exposure section above, the percent of the chronic RfD that will be used for exposure to residues of glufosinate­ ammonium in food for children 1– 6 (the most highly exposed sub­ group) is 61%. Infants utilize 37% of the chronic RfD. As in the adult situation, drinking water levels of comparison are higher than the worst case DWECs and are expected to use well below 100% of the RfD, if they occur at all. Therefore, there is a reasonable certainty that no harm will occur to infants and children from aggregate exposure to residues of glufosinateammonium F. International Tolerances Maximum residue limits (Codex MRLs) for glufosinate­ ammonium and metabolites in or on rice commodities have not been established by the Codex Alimentarius Commission. [FR Doc. 02– 18586 Filed 7– 23– 02; 8: 45 am] BILLING CODE 6560– 50– S ENVIRONMENTAL PROTECTION AGENCY [OPP– 2002– 0084; FRL– 7188– 8] Pesticides; Draft Guidance for Pesticide Registrants on False or Misleading Pesticide Product Brand Names; Extension of Comment Period AGENCY: Environmental Protection Agency (EPA). ACTION: Notice; Extension of comment period. SUMMARY: In the Federal Register of March 28, 2002, EPA published a document announcing the availability of and sought public comment on a draft Pesticide Registration (PR) Notice titled, `` False or Misleading Pesticide Product Brand Names. '' PR Notices are issued by the Office of Pesticide Programs (OPP) to inform pesticide registrants and other interested persons about important policies, procedures, and registration related decisions, and serve to provide guidance to pesticide registrants and OPP personnel. The draft PR Notice provides guidance to registrants, applicants, and the public as to what product brand names may be false or misleading, either by themselves or in association with company names or trademarks. In response to a request from stakeholders, EPA extended the comment period for 60 days, until August 1, 2002, and is now extending the comment period for an additional 90 days, until October 30, 2002. DATES: Comments, identified by docket ID number OPP– 2002– 0084, must be received on or before October 30, 2002. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP– 2002– 0084 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: Jeff Kempter, Antimicrobials Division (7510C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305– 5448; fax number: (703) 308– 6467; e­ mail address: kempter. carlton@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general although this action may be of particular interest to those persons who are required to register pesticides. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the information in this notice, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations, '' `` Regulations and Proposed Rules, '' and then look up the entry for this document under the `` Federal Register— Environmental Documents. '' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. You may obtain an electronic copy of all PR Notices, both final and draft, at http:// www. epa. gov/ opppmsd1/ PR Notices. 2. Fax­ on­ demand. You may request a faxed copy of the draft PR Notice titled, `` False or Misleading Pesticide Product Brand Names, '' by using a faxphone to call (202) 564– 3119 and selecting item 6146. You may also follow the automated menu. 3.In person. The Agency has established an official record for this action under docket ID number OPP– 2002– 0084. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305– 5805. C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP– 2002– 0084 in the subject line on the first page of your response. 1.By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305– 5805. 3. Electronically. You may submit your comments electronically by e­ mail to: opp­ docket@ epa. gov, or you can submit a computer disk as described above. Do not submit any information VerDate Jul< 19> 2002 19: 15 Jul 23, 2002 Jkt 197001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24JYN1. SGM pfrm12 PsN: 24JYN1 48470 Federal Register / Vol. 67, No. 142 / Wednesday, July 24, 2002 / Notices electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in WordPerfect 6.1/ 8.0 or ASCII file format. All comments in electronic form must be identified by docket ID number OPP– 2002– 0084. Electronic comments may also be filed online at many Federal Depository Libraries. D. How Should I Handle CBI That I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the notice. 7. Make sure to submit your comments by the deadline in this notice. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. What Action is EPA Taking? In the Federal Register of March 28, 2002 (67 FR 14941) (FRL– 6809– 9), EPA announced the availability of a draft PR Notice titled, `` Pesticides; Draft Guidance for Pesticide Registrants on False or Misleading Pesticide Product Brand Names. '' The Agency provided a 60– day comment period, which was scheduled to end May 28, 2002. EPA extended the comment period for the draft PR Notice for 60 days in the Federal Register of May 24, 2002 (67 FR 36595) (FRL– 7180– 9), until August 1, 2002, and is now extending the comment period for an additional 90 days, until October 30, 2002. List of Subjects Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests. Dated: July 16, 2002. Marcia E. Mulkey, Director, Office of Pesticide Programs. [FR Doc. 02– 18716 Filed 7– 23– 02; 8: 45 am] BILLING CODE 6560– 50– S ENVIRONMENTAL PROTECTION AGENCY [FRL– 7250– 7] LCP­ Holtrachem Superfund Site; Notice of Proposed Settlement AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of proposed consent order. SUMMARY: The United States Environmental Protection Agency is proposing to enter into a consent order for a removal action pursuant to section 122 of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended, regarding the LCPHoltrachem Superfund Site located in Riegelwood, Columbus County, North Carolina. EPA will consider public comments on the cost recovery component of the proposed settlement, section VIII, for thirty (30) days. EPA may withhold consent to all or part of section VIII of the proposed settlement should such comments disclose facts or considerations which indicate section VIII is inappropriate, improper or inadequate. Copies of the proposed settlement are available from: Ms. Paula V. Batchelor, U. S. EPA, Region 4 (WMD– CPSB), Sam Nunn Atlanta Federal Center, 61 Forsyth Street, SW., Atlanta, Georgia 30303, (404) 562– 8887. Written comments may be submitted to Ms. Batchelor within thirty (30) calendar days of the date of this publication. Dated: July 11, 2002. James T. Miller, Acting Chief, CERCLA Program Services Branch, Waste Management Division. [FR Doc. 02– 18714 Filed 7– 23– 02; 8: 45 am] BILLING CODE 6560– 50– P ENVIRONMENTAL PROTECTION AGENCY [FRL– 7250– 3] Notice of Availability of List of Impaired Waters Prepared by the Commonwealth of Virginia Under the Clean Water Act AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of availability. SUMMARY: On July 15, 2002, the Commonwealth of Virginia published a notice announcing that it was making available for public comment its proposed `` 2002 303( d) Report on Impaired Waters. '' The Department of Environmental Quality (DEQ) of the Commonwealth of Virginia prepared this proposed report pursuant to section 303( d)( 1)( A) of the Clean Water Act (CWA), 33 U. S. C. 1313( d)( 1)( A), and implementing regulations at 40 CFR 130.7( b). The purpose of today's notice is to provide additional notice to the public of the availability of that proposed report. On July 15, 2002, the Virginia Department of Environmental Quality also announced the availability of its 2002 `` 305( b) Water Quality Assessment. '' DATES: Comments on both reports should be sent by midnight August 16, 2002 to the Virginia Department of Environmental Quality. In addition, the Virginia Department of Environmental Quality will hold public information meetings regarding the 303( d) and 305( b) reports on July 29, July 31, and August 1, 2002. ADDRESSES: Submit written comments to Mr. Darryl M. Glover, DEQ Water Quality Monitoring and Assessment Manager, at P. O. Box 10009, Richmond, Virginia 23240– 0009, or via e­ mail to dmglover@ deq. state. va. us. Please include your name, (US mail) address, and telephone number. The public information meetings will be held as follows: July 29th, 2 p. m.– 3: 30 p. m.— DEQ West Central Regional Office, 3019 Peters Creek Road in Roanoke. For directions please call (540) 562– 6700. July 31st, 1: 30 p. m.– 3 p. m.— DEQ Northern Va. Regional Office, 13901 VerDate Jul< 19> 2002 19: 15 Jul 23, 2002 Jkt 197001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24JYN1. SGM pfrm12 PsN: 24JYN1

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regulations

EPA-HQ-OPP-2002-0086-0002

Supporting & Related Material

1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON DC 20460 Office of Prevention, Pesticides and Toxic Substances May 25, 2001 MEMORANDUM SUBJECT: RFA/ SBREFA Certification for Import Tolerance Revocation FROM: Denise Keehner, Division Director, Biological and Economic Analysis Division (7503C), Office of Pesticide Programs, OPPTS, U. S. Environmental Protection Agency TO: Public Docket concerning Tolerance Revocation Rulemaking, Proposed or Final Issue: Because tolerance revocation is rule­ making, the Agency needs to certify ­­ under RFA/ SBREFA ­­ that the tolerance revocation does not impose a significant adverse impact on a substantial number of small entities or conduct an initial and final regulatory flexibility analysis and convene a review panel. Currently, OPP is trying to update the FR notice from 1997 that made a broad, general certification. The same conditions apply now as they did in 1997, but the supporting documentation is being updated, so it is necessary to reconstruct the basis for Agency expectations that import tolerance revocations will not generate significant impacts on substantial numbers of small entities. The primary RFA/ SBREFA focus is on U. S. based import businesses who trade in products that may contain one or more residues being banned under the tolerance revocation. Preliminary Analysis: The arguments for why we would not expect to see significant impacts on a substantial number of small entities can be put into three different categories: 1. Cases where substantial numbers of small entities are not affected because: a. Import companies are not small businesses. b. If import companies are small businesses, then too few are affected to be ineligible for SBREFA certification. 2. Cases where impact on import commodity price is not significant (minimal supply effects) because: a. Affected commodity is widely traded on international markets/ exchanges, and only a small proportion of overall production is treated. b. A small proportion of a crop is treated within a country, suggested the supply within that country will be relatively unaffected. c. There are sufficient alternatives for the chemical with the cancelled tolerance, and these alternatives have few, if any, impacts on output or production costs for the raw agricultural commodity. 3. Cases where there are limited alternatives for the pesticide in a given country, leading 2 to an increase in the supply price, but: a. The supply price is only a proportion of the import price, where the majority of the price reflects transportation and other distribution costs. b. The supply price increases for a particular commodity from a particular country, but it does not impose a significant impact on importer sales because the import company has diversified sales. c. The supply price increases for a particular commodity from a particular country, but there are other sources of the commodity, and the transaction costs of utilizing other suppliers is sufficiently low that it doesn't significantly affect the overall sales of the importing company. Therefore, if ANY of these eight conditions hold, then we can certify that there is no SBREFA issue. Conversely, in order for there to be consideration of a SBREFA concern that would require more detailed analysis, ALL of the following have to hold: 1. There are importers for a particular commodity affected by the tolerance revocation, who qualify as small business under SBA guidelines; AND 2. there is a substantial number of small importers whose sales are affected by the tolerance revocation; AND 3. the affected commodity is NOT widely traded on international markets; AND 4. a sizable proportion of the production in the limited geographic production region is treated with the particular pesticide (suggesting potential supply effects); AND 5. there a limited and/ or expensive alternatives for the particular pesticide in the limited geographic production region, with a concomitant potential for sizable yield loss or increase in cost of production; AND 6. the price of the raw agricultural commodity is a large component of the sales price of the import; AND 7. the importing companies are not diversified, and the increase in raw commodity cost will lead to a significant decline in sales revenue. There is a negligible joint probability of all these conditions holding simultaneously, so I believe it appropriate for the Agency to take the position that import tolerance revocations can be certified under RFA/ SBREFA. I base this conclusion on several observations: most commodities subject to import tolerance revocation are widely traded on international markets (according to USDA's data on agricultural imports and exports) and BEAD's data on foreign pesticide use suggest it is rare for a single pesticide to be extensively used in each production/ export region, such that there is a minimal chance of import tolerance revocation leading to price/ cost increases for importers with an attendant SBREFA concern. Even in the very unlikely event that an import tolerance revocation leads to significant price/ cost increases for a particular commodity, many importers of agricultural commodities are diversified companies dealing in many commodities, so that a price/ cost increase for one commodity will not significantly affect total company revenues. At the same time, it will be useful to continue building a set of data describing why one or more of these seven conditions is not likely to hold. The plan for the medium to long term is to collect such supporting data, sometimes using general industry profiles and sometimes using analyses of specific commodity/ chemical combinations.

epa

2024-06-07T20:31:42.034064

regulations

EPA-HQ-OPP-2002-0087-0001

Rule

Cyhalofop-butyl; Time-Limited Pesticide Tolerance

[ Federal Register: June 7, 2002 ( Volume 67, Number 110)] [ Notices] [ Page 39384­ 39385] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr07jn02­ 71] ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ENVIRONMENTAL PROTECTION AGENCY [ OPP­ 2002­ 0054; FRL­ 7178­ 8] Region III Urban Initiative Grants; Notice of Availability AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ SUMMARY: EPA Region III is announcing the availability of approximately $ 100,000 in fiscal year ( FY) 2002 grant/ cooperative agreement funds under section 20 of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) as amended, ( the Act), for grants to States and federally recognized Native American Tribes for research, public education, training, monitoring, demonstration, and studies. For convenience, the term State'' in this notice refers to all eligible applicants. DATES: In order to be considered for funding during the FY 2002 award cycle, all applications must be received by EPA Region III on or before July 8, 2002. EPA will make its award decisions by June 30, 2002. FOR FURTHER INFORMATION CONTACT: Fatima El Abdaoui, Environmental Protection Agency, Region III, Mail Code 3WC32, Waste Chemicals and Management Division, 1650 Arch St., Philadelphia, PA 19103­ 2029; telephone number: ( 215) 814­ 2129; fax number: ( 215) 814­ 3113; e­ mail address: El­ Abdaoui. Fatima@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. This action may, however, be of interest to eligible applicants who primarily operate out of and will conduct the project in one of the following Region III States: Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, and West Virginia. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select Laws and Regulations,'' Regulations and Proposed Rules, and then look up the entry for this document under the Federal Register­­ Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. [[ Page 39385]] 2. By mail or in person. Contact the person listed under FOR FURTHER INFORMACTION CONTACT. II. Availability of FY 2002 Funds With this publication, EPA Region III is announcing the availability of approximately $ 100,000 in grant/ cooperative agreement funds for FY 2002. The Agency has delegated grant making authority to the EPA Regional Offices. EPA Region III is responsible for the solicitation of interest, the screening of proposals, and the selection of projects. Grant guidance will be provided to all applicants along with any supplementary information Region III may wish to provide. All applicants must address the criteria listed under Unit IV. B. Interested applicants should contact the Regional Urban Initiative coordinator listed un Unit V. for more information. III. Eligible Applicants In accordance with the Act . . . Federal agencies, universities, or others as may be necessary to carry out the purposes of the act, . . .'' are eligible to receive a grant. Eligible applicants for purposes of funding under this grant program include those operating within the six EPA Region III States ( Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, and West Virginia), and any agency or instrumentality of a Region III State including State universities and non­ profit organizations operating within a Region III State. For convenience, the term State'' in this notice refers to all eligible applicants. IV. Activities and Criteria A. General The goal of the Urban Initiative Grant Program is to: ( 1) Detect any diversion of highly toxic pesticides from the agriculture sector into urban areas for illegal use indoors; ( 2) identify any ongoing misuse of agricultural pesticides in urban and residential communities; and ( 3) prevent future diversion and structural application of pesticide misuse through compliance assistance and education. B. Criteria Proposals will be evaluated based on the following criteria: 1. Qualifications and experience of the applicant relative to the proposed project. Does the applicant demonstrate experience in the filed of the proposed activity? Does the applicant have the properly trained staff, facilities, or infrastructure in place to conduct the project? 2. Consistency of applicant's proposed project with the risk reduction goal of the Urban Initiative. 3. Provision for a quantitative or qualitative evaluation of the project's success at achieving the stated goals. Is the project designed in such a way that it is possible to measure and document the results quantitatively and qualitatively? Does the applicant identify the method that will be used to measure and document the project's results quantitatively and qualitatively? Will the project assess or suggest a means for measuring progress in reducing risk associated with the use of pesticides? 4. Likelihood the project can be replicated to benefit other communities or the product may have broad utility to a widespread audience. Can this project, taking into account typical staff and financial restraints, be replicated by similar organizations in different locations to address the same or similar problem? C. Program Management Awards of FY 2002 funds will be managed through EPA Region III. Quality Management Plans and Quality Assurance Project Plans may be required, depending on the nature of the project and the data collected. Contact your Regional Urban Initiative coordinator for more information about this requirement. D. Contacts Interested applicants must contact the appropriate EPA Regional Urban Initiative coordinator listed under Unit V. to obtain specific instructions, regional criteria, and guidance for submitting proposals. V. Region III Urban Initiative Program Contact Region III: ( Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, and West Virginia), Dr. Fatima El Abdaoui, ( 3WC32), 1650 Arch St., Philadelphia, PA 19103; telephone ( 215) 814­ 2129; e­ mail address: El­ Abdaoui. Fatima@ epa. gov. VI. Submission to Congress and the Comptroller General Under the Agency's current interpretation of the definition of a rule,'' grant solicitations such as this which are competitively awarded on the basis of selection criteria, are considered rules for the purpose of the Congressional Review Act ( CRA). The CRA, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996 ( SBREFA), generally provides that before a rule may take effect, the agency promulgating the rules must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This rule is not a major rule'' as defined by 5 U. S. C. 804( 2). List of Subjects Environmental protection, Pesticides, Risk reduction. Dated: May 21, 2002. Thomas C. Voltaggio, Acting Regional Adminstrator, Region III. [ FR Doc. 02­ 14211 Filed 6­ 6­ 02; 8: 45 am] BILLING CODE 6560­ 50­ S

epa

2024-06-07T20:31:42.036860

regulations

EPA-HQ-OPP-2002-0089-0001

Notice

Avermectin; Receipt of Application for Emergency Exemption Solicitation of Public Comment

[ Federal Register: June 5, 2002 ( Volume 67, Number 108)] [ Notices] [ Page 38664­ 38666] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr05jn02­ 43] ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ENVIRONMENTAL PROTECTION AGENCY [ OPP­ 2002­ 0089; FRL­ 7181­ 5] Avermectin; Receipt of Application for Emergency Exemption Solicitation of Public Comment AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ SUMMARY: EPA has received a specific exemption request from the California EPA, Department of Pesticide Regulation, to use the pesticide avermectin ( CAS No. 717517­ 41­ 2) to treat up to 3,000 acres of basil to control leafminer. The Applicant proposes a use which has been requested in 3 or more previous years, and a petition for tolerance has not yet been submitted to the Agency. DATES: Comments, identified by docket ID number OPP­ 2002­ 0089, must be received on or before June 20, 2002. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number 2002­ 0089 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 305­ 6463; fax number: ( 703) 308­ 5433; e­ mail address: sec­ 18­ mailbox@ epamail. epa. gov. SUPPLEMENTARY INFORMATION: General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you petition EPA for emergency exemption under section 18 of FIFRA. Potentially affected categories and entities may include, but are not limited to: ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Examples of Categories NAICS Codes Potentially Affected Entities ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ State government 9241 State agencies that petition EPA for section 18 pesticide exemption ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. Other types of entities not listed in the table in this unit could also be regulated. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action applies to certain entities. To determine whether you or your business is affected by this action, you should carefully examine the applicability provisions. Since other entities also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select Laws and Regulations,'' Regulations and Proposed Rules,'' and then look up the entry for this document under the Federal Register­­ Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. 2. In person. The Agency has established an official record for this action under docket ID number OPP­ 2002­ 0089. The official record consists of the documents specifically referenced in this action, any public comments [[ Page 38665]] received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305­ 5805. C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP­ 2002­ 0089 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305­ 5805. 3. Electronically. You may submit your comments electronically by e­ mail to: opp­ docket@ epa. gov, or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in WordPerfect 6.1/ 8.0 or ASCII file format. All comments in electronic form must be identified by docket ID number OPP­ 2002­ 0089. Electronic comments may also be filed online at many Federal Depository Libraries. D. How Should I Handle CBI that I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the notice. 7. Make sure to submit your comments by the deadline in this document. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. Background A. What Action is the Agency Taking? Under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) ( 7 U. S. C. 136p), at the discretion of the Administrator, a Federal or State agency may be exempted from any provision of FIFRA if the Administrator determines that emergency conditions exist which require the exemption. California EPA, Department of Pesticide Regulation has requested the Administrator to issue a specific exemption for the use of avermectin on basil to control leafminer. Information in accordance with 40 CFR part 166 was submitted as part of this request. As part of this request, the Applicant asserts that during the months of July through September of 1997, a severe leafminer infestation impacted the major basil growing areas of California. It is anticipated this year that if environmental conditions do not change, the basil growers will experience the same if not worse leafminer pest problem. Basil is grown next to various vegetable crops that serve as host plants for leafminers. During the harvesting of these various vegetable crops, leafminers will migrate to the adjacent basil crop that also serves as an ideal host crop. Basil growers do not have an effective registered pesticide to control leafminers. Without avermectin net revenues are estimated at a loss of $ 195 per acre. With the use of avermectin net revenues are estimated to be $ 18 per acre. The Applicant proposes to make no more than two applications per single cutting and no more than 3 to 6 applications can be made per cropping season. Between 0.01 lbs to 0.02 lbs active ingredient may be applied per acre. A maximum of 0.06 lbs active ingredient can be applied per acre per year. Avermectin, formulated as a 2.0% emulsifiable concentrate will be applied to no more than 3,000 acres of basil from July 1, 2002, until October 30, 2002, in California. If the maximum number of acres ( 3,000) were treated at the maximum application rate ( 0.06 lbs) than, a total of 180 lbs of avermectin could be applied. This notice does not constitute a decision by EPA on the application itself. The regulations governing section 18 of FIFRA require publication of a notice of receipt of an application for a specific exemption proposing a use which has been requested in 3 or more previous years, and a petition for tolerance has not yet been submitted to the Agency. The notice provides an opportunity for public comment on the application. The Agency, will review and consider all comments received during the comment period in determining whether to issue the specific exemption requested by the California EPA, Department of Pesticide Regulation. List of Subjects Environmental protection, Pesticides and pests. [[ Page 38666]] Dated: May 22, 2002 Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs. [ FR Doc. 02­ 13524 Filed 6­ 4­ 02; 8: 45 am] BILLING CODE 6560­ 50­ S

epa

2024-06-07T20:31:42.040440

regulations

EPA-HQ-OPP-2002-0090-0001

Notice

Association of American Pesticide Control Officials/State FIFRA Issues Research and Evaluation Group (SFIREG).

Federal Register: June 3, 2002 ( Volume 67, Number 106)] [ Notices] [ Page 38270­ 38271] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr03jn02­ 48] ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ENVIRONMENTAL PROTECTION AGENCY [ OPP­ 2002­ 0090; FRL­ 7181­ 3] Association of American Pesticide Control Officials/ State FIFRA Issues Research and Evaluation Group ( SFIREG) AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ SUMMARY: The Association of American Pesticide Control Officials ( AAPCO)/ State FIFRA Issues Research and Evaluation Group ( SFIREG) will hold a 2­ day meeting, beginning on June 24, 2002, and ending June 25, 2002. This notice announces the location and times for the meeting and sets forth the tentative agenda topics. The purpose of this meeting is to provide an opportunity for States to discuss with EPA environmental matters relating to pesticide registration, enforcement, training and certification, water quality, and disposal. DATES: Comments identified by docket ID number OPP­ 2002­ 0090, must be received on or before July 3, 2002. The meeting will be held on Monday, June 24, 2002, from 8: 30 a. m. to 5 p. m., and Tuesday, June 25, 2002, from 8: 30 a. m. to noon. ADDRESS: This meeting will be held at the Doubletree Hotel, 300 Army Navy Drive, Arlington Crystal City, VA. Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP­ 2002­ 0090 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: Georgia A. McDuffie, Field and External Affairs Division ( 7506C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 605­ 0195; fax number: ( 703) 308­ 1850; e­ mail address: mcduffie. georgia@ epa. gov, or Philip H. Gray, SFIREG Executive Secretary, P. O. Box 1249, Hardwick, VT 05843­ 1249; telephone number: ( 802) 472­ 6956; fax ( 802) 472­ 6957; e­ mail address: aapco@ vtlink. net SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. This action may, however, be [[ Page 38271]] of interest to all parties interested in SFIREG's information exchange relationship with EPA regarding important issues related to human health, environmental exposure to pesticides, and insight into EPA's decision­ making process, and they are invited and encouraged to attend the meetings and participate as appropriate. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select Laws and Regulations,'' Regulations and Proposed Rules,'' and then look up the entry for this document under the Federal Register­­ Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. 2. In person. The Agency has established an official record for this action under docket ID number OPP­ 2002­ 0090. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall i2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m. Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305­ 5805. C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP­ 2002­ 0090 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall i2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305­ 5805. 3. Electronically. You may submit your comments electronically by e­ mail to: opp­ docket@ epa. gov, or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in WordPerfect 6.1/ 8.0 or ASCII file format. All comments in electronic form must be identified by docket ID number OPP­ 2002­ 0090. Electronic comments may also be filed online at many Federal Depository Libraries. D. How Should I Handle CBI that I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the notice or collection activity. 7. Make sure to submit your comments by the deadline in this notice. 8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. Tentative Agenda The following outlines the tentative agenda for the 2­ day meeting. 1. Recommendations of the water quality registration review team. 2. Residual homeowner use chlorpyrifos stocks in the marketplace. 3. An issue review team to study conflicts among FIFRA and other environmental statutes ( discussion). 4. Discussion of Certification and Training Advisory Group recommendations. 5. Discussion on e­ Labeling. 6. Committee reports and introduction of issue papers. 7. Update on current Office of Enforcement and Compliance Assurance activities. 8. Update on current OPP activities. 9. SFIREG issue paper status reports. 10. Regional reports. 11. Other topics as appropriate. List of Subjects Environmental protection, Business and industry, Government contracts, Government property, Security measures. Dated: May 23, 2002. Jay S. Ellenberger, Acting Division Director, Field and External Affairs Division, Office of Pesticide Programs.

epa

2024-06-07T20:31:42.045746

regulations

EPA-HQ-OPP-2002-0095-0001

Notice

Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Peticide Chemical in or on Food

40292 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Notices List of Subjects Environmental protection, Chemicals, Pesticides and pests. Dated: May 21, 2002. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. [ FR Doc. 02 14493 Filed 6 11 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0095; FRL 7181 2] Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number 2002 0095, must be received on or before July 12, 2002. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. C. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number 2002 0095 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 308 3194; e­ mail address: brothers. shaja@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: Categories NAICS codes Examples of potentially affected entities Industry 111 Crop production Categories NAICS codes Examples of potentially affected entities 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations'' and then look up the entry for this document under the `` Federal Register Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. 2. In person. The Agency has established an official record for this action under docket ID number 2002 0095. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physical located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Highway, Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805. C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you indentify docket ID number 2002 0095 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental ProtectionAgency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805. 3. Electronically. You may submit your comments electronically by e­ mail to: opp­ docket@ epa. gov, or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in Wordperfect 6.1/ 8.0 or ASCII file format. All comments in electronic form must be identified by docket ID number 2002 0095. Electronic comments may also be filed online at many Federal Depository Libraries. D. How Should I Handle CBI That I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior VerDate May< 23> 2002 23: 00 Jun 11, 2002 Jkt 197001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 12JNN1. SGM pfrm17 PsN: 12JNN1 40293 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Notices notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. What Action is the Agency Taking? EPA has received a pesticide petition as follows proposing the establishment and/ or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in section 408( d)( 2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition. List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 31, 2002. Peter Caulkins, Acting Director, Registration Division, Office of Pesticide Programs. Summary of Petition The petitioner summary of the pesticide petition is printed below as required by section 408( d)( 3) of the FFDCA. The summary of the petition was prepared by the petitioner and represents the views of the petitioner. EPA is publishing the petition summary verbatim without editing it in any way. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed. Interregional Research Project Number 4 ( IR 4) 0E6185 EPA has received a pesticide petition ( 0E6185) from the Interregional Research Project Number 4 ( IR­ 4), 681 U. S. Highway # 1 South, North Brunswick, NJ 08902 3390 proposing, pursuant to section 408( d) of the FFDCA, 21 U. S. C. 346a( d), to amend 40 CFR part 180 by establishing timelimited tolerances for residues of the herbicide, diflufenzopyr, 2­( 1­( 3,5­ difluorophenylamino) carbonyl) hydrazono) ethyl(­ 3­ pyridinecarboxylic acid, its metabolites convertible to 8­ methylpyrido( 2,3­ d] pyridazin­ 5( 6H)­ 1, and free and acidreleased 8­ hydroxymethylpyrido( 2,3­ d) pyridazine­ 2,5( 1H, 6H)­ dione, expressed as diflufenzopyr in or on the raw agricultural commodities of cattle, goat, hog, horse, and sheep meat at 0.60 parts per million ( ppm); cattle, goat, hog, horse, and sheep kidney at 4.0 ppm; cattle, goat, hog, horse, and sheep meat by­ products ( except kidney) at 0.50 ppm; cattle, goat, hog, horse, and sheep fat at 0.30 ppm; and milk at 3.0 ppm. EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition. This notice includes a summary of the petition prepared by BASF Corporation, P. O. Box 13528, Research Triangle Park, NC, 27709. A. Residue Chemistry 1. Plant metabolism. The nature of the residue of diflufenzopyr is adequately understood. 2. Analytical method. BASF Corporation has provided suitable independently validated analytical methods for detecting and measuring levels of diflufenzopyr and its metabolites in or on food with a limit of detection that allows monitoring of food with residues at or above the levels described in these and the existing tolerances. Adequate enforcement methodology ( gas chromatography) is available to enforce the tolerance expression. 3. Magnitude of residues. Data from metabolism studies in goat and poultry have established that the expected dietary burden from crops treated with diflufenzopr will not result in quantifiable residues above the limits of the standard analytical method. B. Toxicological Profile The nature of the toxic effects caused by diflufenzopyr is discussed in Unit II. B. of the Federal Register of December 12, 2001 ( 66 FR 64257) ( FRL 6812 7). C. Aggregate Exposure The aggregate exposure ( food, drinking water, and residential) assessment for diflufenzopyr is discussed in Unit II. C. of the Federal Register of December 12, 2001 ( 67 FR 64257). D. Cumulative Effects The potential for cumulative effects for diflufenzopyr and other substances with a common mechanism of toxicity is discussed in Unit II. D. of the Federal Register of December 12, 2001 ( 66 FR 64257). E. Safety Determination The safety determination for the U. S. population, infants, and children for diflufenzopyr is discussed in Unit II. E. of the Federal Register of December 12, 2001 ( 66 FR 64257). F. International Tolerances There is no CODEX or Mexican residue limits established for diflufenzopyr or its metabolites. [ FR Doc. 02 14490 Filed 6 11 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0101; FRL 7182 3] Tebufenozide; Receipt of Application for Emergency Exemption, Solicitation of Public Comment AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: EPA has received a specific exemption request from the Vermont Department of Agriculture, Food, and Markets and the Maine Department of Agriculture, Food, and Rural Resources to use the pesticide tebufenozide ( CAS No. 112410 23 8) to treat up to 25,000 acres of pasture and haylands in Vermont and 100,000 acres of pasture and haylands in Maine to control VerDate May< 23> 2002 23: 00 Jun 11, 2002 Jkt 197001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 12JNN1. SGM pfrm17 PsN: 12JNN1

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2024-06-07T20:31:42.049665

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