Source: https://www.federalregister.gov/documents/2000/11/03/00-28277/sodium-o
Timestamp: 2017-09-24 20:16:29
Document Index: 761360886

Matched Legal Cases: ['§\u2009180', '§\u2009180', '§\u2009180', 'art 178', '§180', '§\u2009180', '§\u2009180', '§\u2009180']

Federal Register :: Sodium o
A Rule by the Environmental Protection Agency on 11/03/2000
This regulation is effective November 3, 2000. Objections and requests for hearings, identified by docket control number OPP-301043, must be received by EPA on or before January 2, 2001.
66178-66181 (4 pages)
OPP-301043
FRL-6740-9
VI. Determination of Safety for U.S. Population, Infants and Children-
C. Tolerance Reassessment
D. Codex Maximum Residue Level
X. Submission to Congress and the Comptroller General -
https://www.federalregister.gov/d/00-28277 https://www.federalregister.gov/d/00-28277
This regulation establishes an exemption from the requirement of a tolerance for residues of the active ingredients (a.i.) sodium o-nitophenolate, sodium p-nitrophenolate, sodium 5-nitroguaiacolate, on all food commodities when used as Plant Growth Regulators on growing crops. These three a.i. comprise the end-use product ATONIK®, ASAHI Manufacturing Company, Ltd., c/o Chemical Consultants International, Inc., West 98th Terrace, Suite 100, Overland Park, KS, 66212, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act (FQPA) of 1996, requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of sodium o-nitophenolate, sodium p-nitrophenolate, and sodium 5-nitroguaiacolate and reassess the three existing tolerances for those three a.i..
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 VIII. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket control number OPP-301043 in the subject line on the first page of your response.
By mail: Richard King, 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) 308-8052; e-mail address: king.richard@epa.gov.
2. In person. The Agency has established an official record for this action under docket control number OPP-301043. 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.
In the Federal Register of July 8, 1998 (63 FR 36901) (FRL-5791-6), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a(e), as amended by the FQPA (Public Law 104-170) announcing the filing of a pesticide tolerance petition by ASAHI Manufacturing Company, Ltd., c/o Chemical Consultants International, Inc., West 98th Terrace, Suite 100, Overland Park, KS, 66212. This notice included a summary of the petition prepared by the petitioner ASAHI Manufacturing Company, Ltd. There were no comments received in response to the notice of filing.
New section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) 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 Start Printed Page 66179residential settings, but does not include occupational exposure. Section 408(b)(2)(C) 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....” Additionally, section 408(b)(2)(D) requires that 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.”
The Biopesticide and Pollution Prevention Division (BPPD) has reviewed submitted data to assess the potential hazards and exposures that might result from the proposed use of ATONIK® in or on all food commodities. The plant growth regulator will be formulated into an End-Use product containing a mixture of 0.6% a.i. sodium 5-nitroguaiacolate (1%), sodium o-nitophenolate (0.2%), and sodium p-nitrophenolate (0.3%) by weight and applied to all crops at rates of less than 20 grams a.i. (g a.i.) per acre. Based on the review of submitted information, dose levels and toxicity end-points were evaluated for the use of exposure estimates to characterize potential risks.
The Tier I data was submitted on the end-use product, ATONIK®, each of the three a.i., sodium o-nitrophenolate, sodium p-nitrophenolate, sodium 5-nitoguaiacolate, and a manufacturing use product (a mixture of the components). No toxicity endpoints for dietary, occupational or non-occupational risk charaterizations were indicated because:
1. The no-observed-adverse-effect levels (N0AEL) from dietary administration of the a.i. are 5-6 times higher than that of the developmental toxicity study (1,589 and 1,723 milligrams/kilograms/day (mg/kg/day) for males and females compared with 300 mg/kg/day in pregant rats).
2. The acute toxicity of the end-use product is classified into Toxicity Category IV for the oral (LD50> 5,000 mg/kg) and inhalation LC50> 5.8 mg/L) routes and Toxicity Category III for the dermal route (LD50> 2,000 mg/kg).
3. No developmental effects were noted at dose up to 600 mg/kg/day highest dose tested (HDT).
4. Studies on the three components of the manufacturing use product (MUP) showed no mutagentic activity.
5. The low concentration of the a.i. in the end use product (0.6%).
6. There is a low application rate (< 20 g a.i. per acre).
No toxicity endpoints for dietary, occupational or non-occupational risk characterizations were indicated in subchronic toxicity, developmental toxicity or mutagenicity studies on ATONIK® or its three a.i.. The application rate is so low (< 20 g/acre) that negligible or nonexistent residues would be available for risk characterization. Therefore, considering the lack of toxicity and low exposure no risk characterizations have been conducted for ATONIK®.
1. Food. The end-use product, ATONIK®, contains three a.i. (sodium 5-nitroguaiacolate, sodium o-nitophenolate, and sodium p-nitrophenolate) in very low concentrations. At the application rates employed, the level of each a.i. which may be present in any of the food or feed items would be far below the levels which demonstrated any effects in the subchronic oral feeding study, the developmental toxicity study or the mutagenicity studies. It can be shown that in order to reach a dose rate comparable to the LOAEL of 1,600 mg/kg/day obtained in the subchronic oral feeding study, a person weighing 50 kg (100 lbs.) would have to consume all of the produce from 4 acres of crop every day.
Further, due to the rapid uptake and metabolism of the three a.i. in plants, it is unlikely that any of the residue would be available for potential exposure.
2. Drinking water exposure. Similarly, exposure to humans from consumption of water would be equally unlikely.
Using the previously mentioned criteria, the Agency believes that non-occupational exposures via other routes would be highly unlikely. There is no allowed use of the product containing the three a.i. on lawns, rights-of-way, golf courses, or other areas where human exposure is likely to occur. Therefore, for all practical purposes, exposure from these areas would be non-existent.
Exposure through other pesticides and substances with the same mode of toxicity is not likely. What little toxicity that was observed is only detected at extremely high concentrations of these a.i..
The three a.i. in the End-Use Product, ATONIK®, are all classified as biochemicals. The low toxicity of each of these alone and in combination, as discussed above, demonstrates that these chemicals, at the rates established, will not pose any known risk to human health, either as children or as adults. These three a.i. are already exempted from the requirement of a tolerance for use on cotton, rice, and soybeans.
EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) “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.” Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was scientific basis for including, as part of the program, androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the program include evaluations of potential effects in wildlife. For Start Printed Page 66180pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the EDSP have been developed, sodium o-nitrophenolate, sodium p-nitrophenolate, and sodium 5-nitoguaiacolate, may be subjected to additional screening an/or testing to better characterize effects related to endocrine disruption. Based on the weight of the evidence of available data, no endocrine system-related effect have been identified.
Adequate data for the end-use product, ATONIK®, and each of the three components: sodium o-nitrophenolate, sodium p-nitrophenolate, and sodium 5-nitoguaiacolate, were submitted with the initial registration and petition for tolerances.
The foregoing is a reassessment of the tolerances for § 180.1139 Sodium 5-nitoguaiacolate, and § 180.1140 Sodium o-nitrophenolate, and § 180.1141 Sodium p-nitrophenolate. This reassessment revises these tolerances to include all food commodities when used as plant growth regulators.
No known international tolerances have been granted for this pesticide. Therefore, based on the completeness and reliability of the toxicity data from the published literature and conservative exposure assessment, the Agency concludes that there is a reasonable certainty that no harm will result from aggregate exposure to residues of ATONIK® including all anticipated dietary exposure and all non-occupational exposures.
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-301043 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 January 2, 2001.
3. Copies for the docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VIII.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-301043, 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 file format 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.
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 Start Printed Page 66181the 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).
This final rule establishes an exemption from the tolerance requirement 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 October 4, 1993 (58 FR 51735). 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 prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments May 19, 1998 (63 FR 27655); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations February 16, 1994 (59 FR 7629); or require OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks April 23, 1997 (62 FR 19885). 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 exemption 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 August 10, 1999 (64 FR 43255). 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). -
2. In subpart D §180.1139, 180.1140, and 180.1141 are revised to read as follows:--------
§ 180.1139
Sodium 5-nitroguaiacolate; exemption from the requirements of a tolerance.
The biochemical sodium 5-nitroguiacolate is exempted from the requirement of a tolerance when used as a plant growth regulator in end-use products at a concentration of 0.1% by weight and applied at an application rate of 20 g of a.i. per acre or less per application, in or on all food commodities.
§ 180.1140
§ 180.1141
[FR Doc. 00-28277 Filed 11-2-00; 8:45 am]