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Cyfluthrin (Bayer). July 31, 1996. Time-Limited Pesticide Tolerances. Final Rule. Federal Register.
http://www.epa.gov/docs/fedrgstr/EPA-PEST/1996/July/Day-31/pr-823DIR/pr-823.html
[Federal Register: July 31, 1996 (Volume 61, Number 148)] [Rules and Regulations]
[Page 39883-39887]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 2F4137/R2259; FRL-5387-2]
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 insecticide cyfluthrin, a synthetic pyrethroid, in or on the raw agricultural commodities (RAC's) sorghum, fodder, forage and grain; aspirated grain fractions; the fat of cattle, goats, horses, hogs, and sheep; and milkfat. The regulation to establish a maximum permissible level for residues of the insecticide cyfluthrin was requested in a petition submitted by Bayer Corporation.
EFFECTIVE DATE: This regulation becomes effective July 31, 1996.
ADDRESSES: Written objections and hearing requests, identified by the document control number, [PP 2F4137/R2259], may be submitted to: Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460. A copy of any
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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 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: opp-docket@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
2F4137/R2259] . 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.
Information submitted as a comment concerning this notice 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), Office of Pesticide Programs, Environmental Protection Agency, 401 M St. SW., Washington, DC 20460. Office location and telephone number: Rm. 204, CM #2, 1921 Jefferson Davis Highway, Arlington, VA 22202. (703) 305-6100.
SUPPLEMENTARY INFORMATION: EPA issued a public notice, published in the Federal
Register of December 30, 1992 (57 FR 62334), which announced that Bayer Corp.
(formerly Miles, Inc.) had submitted pesticide petition (PP) 2F4137 to EPA.
Pesticide petition (PP) 2F4137 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) sorghum, forage at 2.0 parts per million (ppm); sorghum,
grain at 4.00 ppm; sorghum, fodder, silage and hay at 5.00 ppm.
In a letter dated October 16, 1995, Bayer Corp. (61 FR 26904, May 29, 1996)
requested that the pesticide petition (2F4137) be amended by increasing the
existing tolerances in or on the fat of cattle, goats, hogs, horses and sheep
to 5.00 ppm; milkfat to 15.00 ppm (reflecting 0.50 ppm in whole milk) and establishing
a tolerance for aspriated grain fraction at 300 ppm. This amendment also addressed
EPA's preference for the sorghum, fodder, silage and hay tolerances to be expressed
in terms of sorghum, fodder. 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,
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 November 2, 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. On July
11, 1996, Bayer Corporation submitted a 21-day subchronic dermal study on Baythroid
2 to the Agency.
The scientific data submitted in the petition and other relevant material have
been evaluated. The toxicology data submitted in support of the tolerance include:
sister chromatid exchange assay); and an unscheduled DNA synthesis assay
in rat hepatocytes. All tests were negative for genotoxicity. 8. A metabolism
study in rats showing that cyfluthrin is rapidly absorbed and excreted,
mostly as conjugated metabolites in the urine, within 48 hours. An enterohepatic
circulation was observed. A chronic dietary exposure/risk assessment was
performed for cyfluthrin using a Reference Dose (RfD) of 0.025 mg/kg bwt/day,
based on a NOEL of 50 ppm (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 in males and inflammation
of the kidneys in females at the LEL of 6.2 mg/kg/day. For purposes of this
dietary exposure/risk assessment tolerance level residues were used and
percent crop treated assumption made for some of the commodities. The current
estimated dietary exposure for the overall U.S. population resulting from
established tolerances is 0.001221 mg/ kg/bwt day, which represents 4.8
percent of the RfD. The current action will increase exposure to 0.009420
mg/kg/bwt/day or 37.6 percent of the RfD. The current estimated dietary
exposure for the subgroup population exposed to the highest risk, non-nursing
infants less than 1 year old, is 0.002081 mg/kg bwt/day, which represents
8.3 percent of the RfD. The current action will increase exposure to 0.025266
mg/kg bwt/day or 101 percent of the RfD. Although the estimate of dietary
exposure for the subgroup, non-nursing infants less than 1 year old, is
slightly higher than the Agency's level of concern, i.e., greater than 100
percent of the RfD, the Agency believes that actual exposure and risk would
be lower. The basis for this is that the risk reflects a higher than actual
dietary exposure because it assumes that 100 percent of the U.S. sorghum
crop is treated with cyfluthrin and that all quantities of the feed consumed
will bear residue levels as high as the proposed tolerance. In reality,
the Agency knows that all sorghum will not be treated with this pesticide
and that actual levels on meat and milk will be lower than tolerance levels.
In addition the food commodity that contributes the most to this slight
risk exceedence is milk at 88.2 percent of the RfD; 71.2 percent from milk
fat and 17 percent from whole milk and milk sugars. Metabolism data indicates
that most of the cyfluthrin will concentrate in milk fat and very little
in the other components, whole milk and milk sugar. Thus the 17 percent
contribution is an overestimate of actual exposure. Thus, EPA concludes
that the chronic dietary risk of cyfluthrin, as estimated by the dietary
risk assessment, does not appear to be of concern. Because there was a sign
of developmental effects seen in animal studies, the Agency used the rabbit
developmental toxicity study with a maternal NOEL of 20 mg/kg/day to assess
acute dietary exposure and determine a margin of exposure (MOE) for the
overall U.S. population and certain subgroups. Since the toxicological end-point
pertains to developmental toxicity, the population group of concern for
this analysis is women aged 13 and above, the subgroup which most closely
approximates women of child-bearing age. The MOE is calculated as the ratio
of the NOEL to the exposure. For this analysis the Agency calculated the
MOE for women ages 13 and above to be 2,500. Generally speaking, MOE's greater
than 100 for data derived from animal studies are regarded as showing no
appreciable risk. The metabolism of cyfluthrin in plants and livestock for
this use is adequately understood. The residues of concern is cyfluthrin
per se. Current established tolerances for cyfluthrin in poultry meat, fat
and meat-by-products are adequate. An adequate analytical method, gasliquid
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 Operations Divisions (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. On August 5, 1988, EPA
issued a conditional registration and timelimited tolerance for cyfluthrin
for use on cottonseed with an expiration date of October 31, 1991 (see the
Federal Register of August 15 ,1988 (53 FR 30676)). On November 12, 1992,
the conditional registration was amended and extended to November 15, 1993
and the tolerance on cottonseed extended to November 15, 1994 (see Federal
Registers October 20, 1993 (58 FR 54094) and February 22, 1994 (54 FR 9411)).
On November 15, 1993, EPA amended the conditional registration on cottonseed
by extending the expiration date to November 15, 1996 and extending the
time-limited tolerance to November 15, 1997. The conditional registration
was amended and extended to allow time for submission and evaluation of
additional environmental effects data. In order to evaluate the effects
of cyfluthrin on fish and aquatic organisms and its fate in the environment,
additional data were required to be collected and submitted during the period
of conditional registration. Such requirements included a sediment bioavailability
and toxicity study and a small-plot runoff study that must be submitted
to the Agency by July 1, 1996. To be consistent with the conditional registration
and extension on cottonseed, the Agency is issuing a conditional registration
with an expiration date of November 15, 1996 and establishing a time-limited
tolerance on sorghum (fodder, forage and grain), aspirated grain fractions
and livestock animal commodities with an expiration date of November 15,
1997, to cover residues expected to result from use during the period of
conditional registration.
Residues remaining in or on the above commodities after expiration of these
tolerances will not be considered actionable if the pesticide is legally
applied during the term and in accordance with provisions of the conditional
registration.
There are presently no actions pending against the continued registration
of this chemical.
The pesticide is considered useful for the purposes for which it is sought.
Based on the information and data considered, the Agency has determined
that the tolerances established by amending 40 CFR 180.436 would protect
the public health. Therefore, the tolerances are established as set forth
below.
Any person adversely affected by this regulation may, within 30 days after
publication of this document in the Federal Register, file written objections
to the regulation and may also request a hearing on those objections. Objections
and hearing requests must be filed with the Hearing Clerk, at the address
given above (40 CFR 178.20). A copy of the objections and/or hearing requests
filed with the Hearing Clerk should be submitted to the OPP docket for this
rulemaking. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by
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40 CFR 180.33(i). If a hearing is requested, the objections must include
a 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
2F4137/R2259] (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 22202.
A copy of electronic objections and hearing request 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 of this rulemaking, as well
as the public eversion, 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<gr-thn-eq>); (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.
This action does not impose any enforceable duty, or contain any unfunded
mandates as described in Title II of the Unfunded Mandates Reform Act of
1995 (Pub. L. 104-4), or require prior consultation as specified by Executive
Order 12875 (58 FR 58093, October 28, 1993), entitled Enhancing the Intergovernmental
Partnership, or special consideration as required by Executive Order 12898
(59 FR 7629, February 16, 1994).
Pursuant to the requirements of the Regulatory Flexibility Act (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 do not have a significant economic impact on a substantial
number of small entities. A certification statement explaining the factual
basis for this determination was published in the Federal Register of May
4, 1981 (46 FR 24950).
Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act (APA) as
amended by the Small Business Regulatory Enforcement Fairness Act of 1996
(Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted a report containing
this rule and other required information to the U.S. Senate, the U.S. House
of Representatives and the Comptroller General of the General Accounting
Office prior to publication of the rule in today's Federal Register. This
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2) of the APA as
amended.
List of Subjects in 40 CFR Part 180
Environmental Protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and record keeping requirements.
Dated: July 19, 1996.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
Therefore, chapter I of title 40 Code of Federal Regulations is amended as follows:
PART 180--[AMENDED]
2. In Sec. 180.436, the table in paragraph (a) is amended by adding alphabetically entries for the commodities ``aspriated grain fractions'' and ``sorghum fodder,'' ``sorghum forage'' and ``sorghum grain;'' and by revising the entries for cattle, fat; goats, fat; hogs, fat; horses, fat; milkfat; and sheep, fat; to read as follows:
Sec. 180.436 Cyfluthrin: tolerances for residues.
(a) * * *
Parts per
Commodity million Expiration date
Aspirated Grain Fractions................................. 300.00 Nov. 15, 1997. Cattle, fat............................................... 5.00 Do.
Goats, fat................................................ 5.00 Do.
Hogs, fat................................................. 5.00 Do.
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Horses, fat............................................... 5.00 Do. Milkfat (reflecting 0.5 ppm in whole milk)................ 15.00 Do.
Sheep, fat................................................ 5.00 Do.
Sorghum, fodder........................................... 5.00 Do. Sorghum, forage........................................... 2.00 Do. Sorghum, grain............................................ 4.00 Do.
[FR Doc. 96-19085 Filed 7-30-96; 8:45 am] BILLING CODE 6560-50-F