[Federal Register Volume 59, Number 203 (Friday, October 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-26195]


[[Page Unknown]]

[Federal Register: October 21, 1994]


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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.

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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 no-
observed-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 5.5% of the 
RfD for the U.S. population or 11% of the RfD if the new tolerances are 
granted. Established tolerances utilize 20% of the RfD for nonnursing 
infants less than 1 year old, the subgroup with the highest estimated 
exposure to cyfluthrin residues or 30% of 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  
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Cattle, fat................................................         0.40
Cattle, meat...............................................         0.40
Cattle, mbyp...............................................         0.40
                                                                        
                                  *****                                 
Milkfat (reflecting 0.08 ppm in whole milk)................         2.50
                                                                        
                                  *****                                 
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[FR Doc. 94-26195 Filed 10-20-94; 8:45 am]
BILLING CODE 6560-50-F