cyfluthrin (Baythroid) Proposed Pesticide Tolerances 10/94
40 CFR Part 180
[PP 1F3923/P593; FRL-4916-1]
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
DATES: Comments, identified by the document control number,
[PP 1F3923/P593], must be received on or before November 21,
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-
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
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
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
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
1. The authority citation for part 180 continues to read
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.
* * * * *
Commodity Parts per
* * * * *
Milkfat (reflecting 0.08 ppm in whole milk)....................2.50
* * * *
[FR Doc. 94-26195 Filed 10-20-94; 8:45 am]