Source: https://www.federalregister.gov/articles/2002/09/18/02-23745/indoxacarb-pesticide-tolerance-for-emergency-exemption
Timestamp: 2016-08-27 22:21:15
Document Index: 388422164

Matched Legal Cases: ['art 180', 'art 166', 'art 180', 'ART 180', 'art 180', '§ 180']

Federal Register | Indoxacarb; Pesticide Tolerance for Emergency Exemption
Publication Date: Wednesday, September 18, 2002
Dates: This regulation is effective September 18, 2002. Objections and requests for hearings, identified by docket ID number OPP-2002-0256, must be received on or before November 18, 2002.
Effective Date: 09/18/2002
-58730 (6 pages)
Document Number: 02-23745
Shorter URL: https://federalregister.gov/a/02-23745 Related Topics
B. Exposure Assessment-
B. International Residue Limits-
C. Conditions-
IX. Submission to Congress and the Comptroller General-
Table 1.—Aggregate Risk Assessment for Acute Exposure to Indoxacarb
Table 2.—Aggregate Risk Assessment for Chronic Exposure to Indoxacarb
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/. 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.-
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 submit or 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.1. Once in the system, select “search,” then key in the appropriate docket ID number.
II. Background and Statutory Findings- Back to Top
III. Emergency Exemption for Indoxacarb on Cranberry and FFDCA Tolerances- Back to Top
The Massachusetts Department of Food and Agriculture have indicated that populations of the cranberry weevil in the state have developed resistance to the registered alternative, chlorpyrifos. Without adequate control, this pest was expected to result in significant crop damage and yield losses for cranberry growers, leading to significant economic losses. The state requested indoxacarb for this use, since field trials have shown it to be effective at controlling this pest. EPA has authorized under FIFRA section 18 the use of indoxacarb on cranberry for control of the cranberry weevil in Massachusetts. After having reviewed the submission, EPA concurs that emergency conditions exist for this State.-
As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of indoxacarb in or on cranberry. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although this tolerance will expire and is revoked on December 31, 2004, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on cranberry after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this tolerance at the time of that application. 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.- Because this tolerance is being approved under emergency conditions, EPA has not made any decisions about whether indoxacarb meets EPA's registration requirements for use on cranberry or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this tolerance serves as a basis for registration of indoxacarb by a State for special local needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for any State other than Massachusetts to use this pesticide on this crop under section 18 of FIFRA without following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for indoxacarb, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety- Back to Top
The Dietary Exposure Evaluation Model (DEEM
) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. -
Using these exposure assumptions, EPA concluded that indoxacarb acute exposures from food consumption are below levels of concern (100% of the acute Population Adjusted Dose (aPAD)) for the general US population and all population subgroups. The amount of the aPAD utilized for the most highly exposed subgroup, Females (13-50 yrs old) is 41%. Acute risk from dietary exposure for the most highly exposed infant/children subpopulation, Children (1-6 yrs old) is at 12% of the aPAD. For the general US Population and all other population subgroups, acute risk from dietary exposure is estimated at 6% of the aPAD. In addition, despite the potential for acute dietary exposure to indoxacarb in drinking water, after calculating drinking water levels of concern (DWLOCs) and comparing them to conservative model estimated environmental concentrations (EECs) of indoxacarb in surface and ground waters, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 1.
General US Population
Females (13-50 yrs old)
Children (1-6 yrs old)
-The following assumptions were made for the chronic exposure assessments: The chronic dietary assessment assumed tolerance level residues, default processing factors and 100% CT. Refinements using ARs, actual processing factors, and %CT data would result in lower chronic dietary exposure estimates.-
Using these exposure assumptions, EPA concluded that indoxacarb chronic exposures from food consumption are below levels of concern (100% of the cPAD) for the general US population and all population subgroups. The cPAD utilized for the most highly exposed subgroup, Children (1-6 yrs old) is 90%. Chronic risk from dietary exposure for Infants (1 year old) is 4% of the cPAD, and for Children (7-12 yrs old) it is 52% of the cPAD. Chronic dietary risk for the general US Population is 36% of the cPAD, and the estimated chronic risk for all other population subgroups is below this level. In addition, despite the potential for chronic dietary exposure to indoxacarb in drinking water, after calculating DWLOCs and comparing them to conservative model EECs of indoxacarb in surface and ground waters, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 2.
Children (7-12 yrs old)
Infants (1 yr old)
-Short and intermediate term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Indoxacarb is not registered for use on any sites that would result in residential exposure, and thus short- and intermediate-term exposures are not expected, so these risk assessments were not conducted.-
VI. Conclusion- Back to Top
VII. Objections and Hearing Requests- Back to Top
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.”-
3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VII.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.1. Mail your copies, identified by the docket ID number OPP-2002-0256, 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 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. 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.
VIII. Regulatory Assessment Requirements-- Back to Top
IX. Submission to Congress and the Comptroller General- Back to Top
List of Subjects in 40 CFR Part 180- Back to Top
PART 180—[AMENDED]- Back to Top
1.The authority citation for part 180 continues to read as follows:- Authority:
2. Section 180.564 is amended by adding the following language and table to paragraph (b) to read as follows: § 180.564 Indoxacarb; tolerances for residues.-
(a) ***-