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Cyfluthrin (Miles, ex Mobay). October 21 1994, Petition for Pesticide Tolerances. Federal Register.


http://www.epa.gov/fedrgstr/EPA-PEST/1994/October/Day-21/pr-5.html

Pesticide Tolerances for Cyfluthrin

[Federal Register: October 21, 1994]

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 1F3923/P593; FRL-4916-1]
RIN 2070-AC18

Pesticide Tolerances for Cyfluthrin

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.


SUMMARY: EPA proposes to amend tolerances for residues of the synthetic pyrethroid cyfluthrin in or on the raw agricultural commodities (RAC's) milk, meat, fat, and meat byproducts of cattle and establish a tolerance for milkfat. The proposed regulation to amend the tolerances and establish a maximum permissible level for residues of the pesticide in milkfat was requested in a petition submitted by Miles Corp., Animal Products (formerly Mobay Corp.).

DATES: Comments, identified by the document control number, [PP 1F3923/ P593], must be received on or before November 21, 1994.

ADDRESSES: By mail, submit written comments to: Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: In person, bring comments to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
Information submitted as a comment concerning this document may be claimed confidential by marking any part or all of that information as ``Confidential Business Information'' (CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the comment 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. All written comments will be available for public inspection in Rm. 1132 at the address given above, from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: George T. LaRocca, Product Manager (PM 13), Registration Division (7505C), Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Rm. 200, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6100.

SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the Federal Register of April 3, 1991 (56 FR 13642), which announced that Miles Corp. had submitted pesticide petition (PP) 1F3923 to EPA requesting that the Administrator, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), amend 40 CFR 180.436 by increasing tolerances for residues of the insecticide cyfluthrin, [cyano[4-fluoro-3-phenoxyphenyl]-methyl-3-[2,2- dichloroethenyl]-2,2-dimethylcyclopropanecarboxylate], in or on the raw agricultural commodities milk to 0.08 part per million (ppm) (from 0.01 ppm) and meat, fat, and meat byproducts of cattle to 0.40 ppm (from 0.05 ppm). The proposal to increase tolerances was submitted in support of direct application (pour-on) of the pesticide Bayocide Pour On Insecticide containing cyfluthrin to lactating dairy and beef cattle. A review of the data indicated that cyfluthrin residues concentrate in fat; therefore, Miles Corp. was asked to amend the petition by requesting an appropriate milkfat tolerance. On February 14, 1994, Miles Corp. submitted an amended pesticide petition proposing that tolerances be established for milkfat at 2.5 ppm (reflecting 0.08 ppm in whole milk).


The data submitted in support of these tolerances and other relevant material have been evaluated. The toxicological and metabolism data and analytical methods for enforcement purposes considered in support of these tolerances are discussed in detail in related documents published in the Federal Register of August 16, 1989 (54 FR 33718).


A dietary exposure/risk assessment was performed for cyfluthrin using a Reference Dose (RfD) of 0.025 mg/kg bwt/day, based on a noobserved -effect-level (NOEL) of 2.5 mg/kg/ bwt/day and an uncertainty factor of 100. The NOEL was determined in a 2-year rat feeding study. The endpoint effects of concern were decreased body weights and inflammation of the kidneys. The Theoretical Maximum Residue Contribution (TMRC) from established tolerances utilizes 5.512f the RfD for the U.S. population or 1112f the RfD if the new tolerances are granted. Established tolerances utilize 2012f the RfD for nonnursing infants less than 1 year old, the subgroup with the highest estimated exposure to cyfluthrin residues or 3012f the RfD if the new tolerances are granted. Generally speaking, EPA has no cause for concern if total residue contribution for published and proposed tolerances is less than the RfD.
The metabolism of the chemical in animals for these uses is adequately understood. An adequate analtyical method, gas-liquid chromatography, is available for enforcement purposes. The enforcement methodology has been submitted to the Food and Drug Administration for publication in the Pesticide Analytical Manual, Vol. II (PAM II). Because of the long lead time for publication of the method in PAM II, the analytical methodology is being made available in the interim to anyone interested in pesticide enforcement when requested from: Calvin Furlow, Public Response and Program Resources Branch, Field Opearations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-5232. There are currently no actions pending against the continued registration of this chemical.


Based on the information and data considered, the Agency has determined that the tolerances established by amending 40 CFR part 180 would protect the public health. Therefore, it is proposed that the tolerances be established as set forth below. Any person who has registered or submitted an application for registration of a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as amended which contains any of the ingredients listed herein may request within 30 days after publication of this document in the Federal Register that this rulemaking proposal be referred to an Advisory Committee in accordance with section 408(e) of the FFDCA.


Interested persons are invited to submit written comments on the proposed regulations. Comments must bear a notation indicating the document control number, [PP 1F3923/P593]. All written comments filed in response to these petitions will be available in the Public Response and Program Resources Branch, at the address given above from 8 a.m. to 4 p.m., Monday through Friday, except legal holidays. Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency must determine whether the regulatory action is ``significant'' and therefore subject to all the requirements of the Executive Order (i.e., Regulatory Impact Analysis, review by the Office of Management and Budget (OMB)). Under section 3(f), the order defines ``significant'' as those actions likely to lead to a rule (1) having an annual effect on the economy of $100 million or more, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities (also known as ``economically significant''); (2) creating serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement, grants, user fees, or loan programs; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order. Pursuant to the terms of this Executive Order, EPA has determined that this rule is not ``significant'' and is therefore not subject to OMB review.


Pursuant to the requirements of the Regulatory Flexibility Act (Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator has determined that regulations establishing new tolerances or raising tolerance levels or establishing exemptions from tolerance requirements, or establishing or raising food additive regulations do not have a significant economic impact on a substantial number of small entities. A certification statement to this effect was published in the Federal Register of May 4, 1981 (46 FR 24950).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: October 11, 1994.

Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.

Therefore, it is proposed that 40 CFR part 180 be amended as follows:

PART 180--[AMENDED]

  1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 346a and 371.

    2. By amending Sec. 180.436 in the table therein by revising the entries for the fat, meat, and meat byproducts (mbyp) of cattle and revising the entry for milk, to read as follows:

    Sec. 180.436 Cyfluthrin; tolerances for residues.

    • * * * *

                                                                  Parts per 
                             Commodity                             million  
    

    Cattle, fat................................................ 0.40 Cattle, meat............................................... 0.40 Cattle, mbyp............................................... 0.40
                                                                            
                                      *****                                 
    

    Milkfat (reflecting 0.08 ppm in whole milk)................ 2.50

                                                                            
                                      *****                                 
    

[FR Doc. 94-26195 Filed 10-20-94; 8:45 am] BILLING CODE 6560-50-F