[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.
* * * * *
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Parts per
Commodity million
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Cattle, fat................................................ 0.40
Cattle, meat............................................... 0.40
Cattle, mbyp............................................... 0.40
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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
