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Cyfluthrin (Bayer -ex Miles Corp.). March 15, 1996. Time-Limited Pesticide Tolerance. Final Rule. Federal Register.
http://www.epa.gov/docs/fedrgstr/EPA-PEST/1996/March/Day-15/pr-600.html
[Federal Register: March 15, 1996 (Volume 61, Number 52)] [Rules and Regulations]
[Page 10678-10681]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180
[PP 4F4309/R2216; FRL-5354-9]
RIN 2070-AB78
Cyfluthrin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This document establishes time-limited tolerances with an expiration date of November 15, 1997, for residues of the synthetic pyrethroid cyfluthrin in or on the raw agricultural commodities (RAC's) alfalfa, sunflowers, and fat of cattle, goats, horses, hogs, and sheep; and an expiration date of July 5, 1999 for residues of cyfluthrin in or on sweet corn. The proposed tolerances and regulations to establish a maximum permissible level for residues of the pesticide was requested in a petition submitted by Bayer Corp. (formerly Miles Corp.).
EFFECTIVE DATE: This regulation becomes effective March 15, 1996.
ADDRESSES: Written objections and hearing requests, identified by the document control number, [PP 4F4309/R2216], may be submitted to: Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460. A copy of any objections and hearing requests filed with the Hearing Clerk should be identified by the document control number and submitted 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. In
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person, bring copy of objections and hearing requests to Rm. 1132, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202. Fees accompanying objections shall
be labeled ``Tolerance Petition Fees'' and forwarded: EPA Headquarters Accounting
Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251.
An electronic copy of objections and hearing requests filed with the Hearing
Clerk may be submitted to OPP by sending electronic mail (e-mail) to: oppdocket
@epamail.epa.gov.
Copies of electronic objections and hearing requests must be submitted as an
ASCII file avoiding 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 5.1 file format or ASCII file format. All copies of electronic
objections and hearing requests must be identified by the docket number [PP
4F4309/R2216]. No Confidential Business Information (CBI) should be submitted
through email. Copies of electronic objections and hearing requests on this
rule may be filed online at many Federal Depository Libraries. Additional information
on electronic submissions can be found below in this document.
FOR FURTHER INFORMATION CONTACT: By mail: George T. LaRocca, Product Manager
(PM) 13, Registration Division (7505C), Office of Pesticide Programs, 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; e-mail: larocca.george@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a public notice, published in the Federal
Register of July 13, 1994 (59 FR 35719), which announced that Bayer Corp. had
submitted pesticide petition (PP) 4F4309 and feed additive petition (FAP) 4H5686
to EPA.
Pesticide petition (PP) 4F4309 requests that the Administrator, pursuant to
sections 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C.
346a(d) and 348(b), amend 40 CFR 180.436 by establishing tolerances for residues
of the insecticide cyfluthrin, [cyano[4-fluoro-3-phenoxyphenyl]- methyl-3-[2,2-dicloroethenyl]-2,2-
dimethylcyclopropanecarboxylate] in or on the raw agricultural commodities (RACs)
sweet corn, forage at 54.0 ppm; alfalfa, hay at 10.0 ppm; soybean, forage at
10.0 ppm; alfalfa, forage at 5.0 ppm; soybean, hay at 1.5 ppm; sunflower, forage
at 1.0 ppm; sweet corn at 0.05 ppm; soybeans at 0.03 ppm and sunflower, seed
at 0.02 ppm. Food/feed additive petition (FAP) 4H5686 requests that the Administrator
pursuant to section 409(e) of the FFDCA (21 U.S.C. 348(e)) amend 40 CFR 186.1250
by establishing a food/feed additive regulation for cyfluthrin in or on sunflower
hulls at 2.5 ppm and soybean hulls at 0.1 ppm.
On September 18, 1995, Bayer Corp. requested (60 FR 64059, December 13, 1995)
that the pesticide petition (4F4309) be amended by decreasing the proposed tolerances
on sweet corn forage from 54.0 ppm to 30.0 ppm; increasing tolerances for fat
of cattle, goats, hogs, horses and sheep from 0.05 ppm to 5.0 ppm; establishing
a tolerance of 15.0 ppm for milkfat (representing 0.5 ppm in whole milk); and
withdrawing proposed tolerances for soybean forage, soybean hay, and soybeans;
and the food/ feed additive regulation petition (3H5686) for sunflower hulls
at 2.5 ppm and soybeans hulls at 0.1 ppm without prejudice to future filing.
On November 3, 1995, Bayer Corp. requested that the pesticide petition (4F4309)
be further amended by reducing the tolerances for fat of cattle, goats, hogs,
horses and sheep from 5.0 ppm to 1.0 ppm; and withdrawing the tolerance for
milkfat. An increased milkfat tolerance was established in (59 FR 53130, May
31, 1995) at 2.5 ppm (reflecting 0.08 ppm in whole milk) which adequately addresses
secondary tolerances for this proposed action. This amendment also addressed
EPA's preference for the sweet corn tolerance to be expressed in terms of kernel
plus cob with husk removed (K+CWHR). There were no comments or requests to the
advisory committee received in response to the initial and amended notices of
filing. The data base for cyfluthrin is essentially complete. Data lacking but
desirable are a new 21-day subchronic dermal study, an acute neurotoxicity study
in rats, and a 90-day neurotoxicity study in rats and a dermal sensitization
study on the end use product Baythroid 2. Although these data are lacking, the
Agency believes it has sufficient toxicity data to support the proposed tolerance,
and these missing data will not significantly change its risk assessment. In
a letter dated April 20, 1995, Bayer Corp. has committed to submit the 21-day
subchronic dermal study by June 1996, the acute neurotoxicity study by December
1996, and the 90-day neurotoxicity study by May 1997. On October 12, 1995, Bayer
Corp submitted to the Agency a dermal sensitization study on Baythroid 2.
The scientific data submitted in the petition and other relevant material have
been evaluated. The toxicology data submitted in support of the tolerance include:
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statement of the factual issue(s) on which a hearing is requested, the requestor's
contentions on such issues, and a summary of any evidence relied upon by
the objector (40 CFR 178.27). A request for a hearing will be granted if
the Administrator determines that the material submitted shows the following:
There is 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 the requestor, taking into
account uncontested claims or facts to the contrary; and resolution of the
factual issue(s) in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32). A record has been established
for this rulemaking under docket number [PP 4F4309/R2216] (including objections
and hearing requests submitted electronically as described below). A public
version of this record, including printed, paper versions of electronic
comments, which does not include any information claimed as CBI, is available
for inspection from 8 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The public record is located in Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division (7506C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal Mall
#2, 1921 Jefferson Davis Highway, Arlington, VA. Written objections and
hearing requests, identified by the document control number [PP 4F4309/R2216],
may be submitted to the Hearing Clerk (1900), Environmental Protection Agency,
Rm. 3708, 401 M St., SW., Washington, DC 20460.
A copy of electronic objections and hearing requests filed with the Hearing
Clerk can be sent directly to EPA at: opp-Docket@epamail.epa.gov
A copy of electronic objections and hearing requests filed with the Hearing
Clerk must be submitted as an ASCII file avoiding the use of special characters
and any form of encryption. The official record for this rulemaking, as
well as the public version, as described above will be kept in paper form.
Accordingly, EPA will transfer any objections and hearing requests received
electronically into printed, paper form as they are received and will place
the paper copies in the official rulemaking record which will also include
all objections and hearing requests submitted directly in writing. The official
rulemaking record is the paper record maintained at the address in ``ADDRESSES''
at the beginning of this document. Under Executive Order 12866 (58 FR 51735,
October 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: March 6, 1996.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, chapter I of title 40 of the Code of Federal Regulations is amended as follows:
PART 180--[AMENDED]
a. The authority citation of part 180 continues to read as follows:
Authority: 21 U.S.C. 346a and 371.
b. In Sec. 180.436, the table to paragraph (a) by adding alphabetically entries for ``alfalfa, forage'', ``alfalfa, hay'', ``sunflower, forage'', and ``sunflower, seed'', and by revising the entries ``cattle, fat'', ``goats, fat'', ``hogs, fat'', ``horses, fat'', and ``sheep, fat'', and in paragraph (b) by revising the table, to read as follows:
Sec. 180.436 Cyfluthrin, tolerances for residues.
(a) * * *
Parts perCommodity million Expiration date
Parts per Expiration Commodity million date
1999Corn, grain, field and pop.................... 0.01 Do. Corn, sweet, (K+CWHR)......................... 0.05 Do Corn, sweet, fodder........................... 15.00 Do.
[FR Doc. 96-6250 Filed 3-14-96, 8:45 am]
BILLING CODE 6560-50-F