[Federal Register Volume 60, Number 70 (Wednesday, April 12, 1995)]
[Proposed Rules]
[Pages 18562-18565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9149]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180, 185, and 186
[PP 9F3731 and FAP 9H5574/P612; FRL-4948-4]
RIN 2070-AC18
Cyfluthrin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish 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)
tomatoes; carrots; peppers; radishes; meat, fat, and meat byproducts of
cattle, goats, horses, hogs, poultry, and sheep; milkfat; and eggs and
in food/feed additive commodities tomato, pomace (dry and wet) and
tomato concentrated products. Miles Corp., Animal Products (formerly
Mobay Corp.), requested the proposed tolerances and regulations to
establish maximum permissible levels for residues of the pesticide.
DATES: Comments, identified by the document control number, [PP 9F3731
and FAP 9H5574/P612], must be received on or before May 12, 1995.
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. In person, bring comments to: Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA 22202.
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. 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 March 23, 1989 (54 FR 35434), which announced that
Miles Corp. had submitted pesticide petition (PP) 9F3731 and food/feed
additive petition (FAP) 9H5574 to EPA.
Pesticide petition (PP) 9F3731 requests 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-dicloroethenyl)-2,2-
dimethylcyclopropanecarboxylate, in or on the raw agricultural
commodities alfalfa forage at 5.0 ppm; alfalfa hay at 10.0 ppm;
broccoli at 2.0 ppm; brussels sprouts at 0.5 ppm; cabbage at 1.0 ppm;
cauliflower at 0.5 ppm; carrots at 0.1 ppm; celery at 1.5 ppm; lettuce
at 2.5 ppm; peppers at 0.2 ppm; radishes at 0.5 ppm; spinach at 1.0
ppm; sweet corn at 0.05 ppm; sweet corn forage at 1.0 ppm; sunflower
seed at 0.02 ppm; sunflower forage at 1.0 ppm; soybeans at 0.03 ppm;
soybean forage at 10.0 ppm; soybean hay at 1.5 ppm; soybean straw at
1.0 ppm; tomato at 0.2 ppm; milk at 0.1 ppm; eggs at 0.01 ppm; meat,
fat and meat byproduct of cattle, goats, hogs, horses, and sheep at 1.5
ppm; and meat, fat, and meat byproducts of poultry at 0.01 ppm.
Food/feed additive petition (FAP) 9H5574 requests that the
Administrator, pursuant to section 409(e) of the FFDCA (21 U.S.C.
348(e)) amend 40 CFR parts 185 and 186 by establishing a food/feed
additive regulation for cyfluthrin in or on processed food commodities
tomato concentrated products at 0.5 ppm and feed commodities sweet corn
(cannery wastes) at 1.5 ppm; tomato, pomace (wet) at 1.5 ppm; tomato,
pomace dry at 5.0 ppm.; soybean hulls at 0.1 ppm; and sunflower hulls
at 2.5 ppm.
On July 20, 1993, Miles Corp. requested that the pesticide petition
and food/feed additive petition be amended by withdrawing the proposed
tolerance [[Page 18563]] for broccoli, brussels sprouts, cabbage,
cauliflower, celery, lettuce, soybeans (straw), spinach and the feed
additive regulation for sweet corn (cannery wastes) without prejudice
to future filing and by raising the tolerances for carrots, peppers,
and radishes to 0.2, 0.5 and 1.5 ppm, respectively. In a letter dated
November 18, 1993, Miles amended the petition by withdrawing the crops
alfalfa, soybeans, sweet corn, and sunflowers from the subject
petitions and proposing them under a separate petition. On June 10,
1994, Miles requested that the pesticide petition be further amended by
reducing the tolerance for radishes to 1.0 ppm; proposing one tolerance
for wet and dry tomato pomace; reducing the animal commodities to 0.4
ppm; and revising the milk tolerances to be expressed as 2.5 ppm milk
fat (reflecting 0.08 ppm in whole milk). This amendment was submitted
in response to EPA's preference that an integer tolerance (i.e, one
significant figure) rather than a fraction be proposed for radishes;
EPA's current practice to set one tolerance on tomato pomace, wet and
dry, rather than individual tolerances on the two pomaces; and to make
the above tolerances for animal commodities consistent with the feed
items in this petition.
The scientific data submitted in the petition and other relevant
material have been evaluated. All toxicology data necessary to support
these tolerances have been previously submitted, reviewed, and
accepted. The toxicology data considered in support of the proposed
tolerance include:
1. A 12-month chronic feeding study in dogs with a no-observed-
effect level (NOEL) of 4 mg/kg/day. The lowest-effect level (LEL) for
this study is established at 16 mg/kg/day, based on slight ataxia,
increased vomiting, diarrhea, and decreased body weight.
2. A 24-month chronic feeding/carcinogenicity study in rats with a
NOEL of 2.5 mg/kg/day and LEL of 6.2 mg/kg/day, based on decreased body
weights in males and females, decreased food consumption in males, and
inflammatory foci in the kidneys in females. There were no carcinogenic
effects observed under the conditions of the study.
3. A 24-month carcinogenicity study in mice. There were no
carcinogenic effects observed under the conditions of the study.
4. An oral developmental toxicity study in rats with a maternal and
fetal NOEL of 10 mg/kg/day (highest dose tested). An oral developmental
toxicity study in rabbits with a maternal NOEL of 20 mg/kg/day and a
maternal LEL of 60 mg/kg/day, based on decreased body weight gain and
decreased food consumption during the dosing period. A fetal NOEL of 20
mg/kg/day and a fetal LEL of 60 mg/kg/day were also observed in this
study. The LEL was based on increased resorptions and increased
postimplantation loss.
5. A developmental toxicity study in rats by the inhalation route
of administration with a maternal NOEL of 0.0011 mg/L and an LEL of
0.0047 mg/L, based on reduced mobility, dyspnea, piloerection,
ungroomed coats, and eye irritation. The fetal NOEL is 0.00059 mg/L and
the fetal LEL is 0.0011 mg/L, based on sternal anomalies and increased
incidents in runts. A second developmental toxicity study in rats by
the inhalation route of administration is currently under review. The
issue of whether cyfluthrin directly induces fetotoxicity under these
conditions is unresolved at this time.
6. A three-generation reproduction study in rats with a systemic
NOEL of 2.5 mg/kg/day and a systemic LEL of 7.5 mg/kg/day due to
decreased parent and pup body weights. The reproductive NOEL and LEL
are 7.5 mg/kg/day and 22.5 mg/kg/day, respectively.
7. Mutagenicity tests, including a gene mutation assay (reverse
mutation and recombination assays in bacteria and a Chinese hamster
ovary (CHO)/(HGPRT)); a structural chromosome aberration assay (CHO/
sister chromatid exchange assay); and an unscheduled DNA synthesis
assay in rat hepatocytes. All test 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 end-
point effects of concern were decreased body weights in males and
inflammation of the kidneys in females at the LEL of 150 ppm (6.2 mg/
kg/day). The current estimated dietary exposure for the overall U.S.
population resulting from established tolerances is 0.001378 mg/kg/bwt
day, which represents 5.5 % of the RfD. The current action will
increase exposure to 0.002730 mg/kg/ bwt/day or 11% of the RfD. In the
subgroup population exposed to the highest risk, nonnursing infants
less than 1 year old, the current action will increase exposure to
0.008044 mg/kg bwt/day or 32% of the RfD. Generally speaking, EPA has
no cause for concern if total residue contribution for published and
proposed tolerances is less than the RfD. 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 rat developmental toxicity study (with a
NOEL of 0.00059 mg/L by the inhalation route of exposure) 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 1,250.
Generally speaking, MOE's greater than 100 for data derived from animal
studies are acceptable to the Agency.
The metabolism of the chemical in animals for this use is
adequately understood. An adequate analytical 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 Operations
Divisions (7506C), Office of Pesticide Programs, Environmental
Protection Agency 401 M St., 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 time-
limited 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 the 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 [[Page 18564]] 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
proposing to issue a conditional registration with an expiration date
of November 15, 1996, and establishing a time-limited tolerance on
tomatoes, carrots, peppers, radishes, meat, milk, and egg tolerances
with an expiration date of November 15, 1997, to cover residues
expected to result from use during the period of 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 parts
180, 185, and 186 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 regulation. Comments must bear a notation indicating the
document control number, [PP 9F3731 and FAP 9H5574/P612]. All written
comments filed in response to this petition 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
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 Parts 180, 185, and 186
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Feed additives, Food additives, Pesticides
and pests, Reporting and recordkeeping requirements.
Dated: April 5, 1995.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that chapter I of title 40 of the Code of
Federal Regulations be amended as follows:
PART 180--[AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
b. By amending Sec. 180.436, by revising the table therein, to read
as follows:
Sec. 180.436 Cyfluthrin; tolerances for residues.
* * * * *
------------------------------------------------------------------------
Parts per Expiration
Commodities million date
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Carrots....................................... 0.20 Nov. 15,
1997
Cattle, fat................................... 0.40 Do.
Cattle, meat.................................. 0.40 Do.
Cattle, mbyp.................................. 0.40 Do.
Cottonseed.................................... 1.0 Do.
Eggs.......................................... 0.01 Do.
Goats, fat.................................... 0.40 Do.
Goats, meat................................... 0.40 Do.
Goats, mbyp................................... 0.40 Do.
Hogs, fat..................................... 0.40 Do.
Hogs, meat.................................... 0.40 Do.
Hogs, mbyp.................................... 0.40 Do.
Hops, fresh................................... 4.0 None
Horses, fat................................... 0.40 Nov. 15,
1997
Horses, meat.................................. 0.40 Do.
Horses, mbyp.................................. 0.40 Do.
Milkfat (reflecting 0.08 ppm in whole milk)... 2.50 Do.
Peppers....................................... 0.50 Do.
Poultry, fat.................................. 0.01 Do.
Poultry, meat................................. 0.01 Do.
Poultry, mbyp................................. 0.01 Do.
Radishes...................................... 1.00 Do.
Sheep, fat.................................... 0.40 Do.
Sheep, meat................................... 0.40 Do.
Sheep, mbyp................................... 0.40 Do.
Tomato........................................ 0.20 Do.
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PART 185--[AMENDED]
2. In part 185:
a. The authority citation for part 185 continues to read as
follows:
Authority: 21 U.S.C. 346a and 348.
b. In Sec. 185.1250, by revising paragraph (a) and removing
paragraph (b) and designating it as reserved, as follows:
Sec. 185.1250 Cyfluthrin.
(a) A tolerance, to expire on November 15, 1997 is established for
residue of the insecticide cyfluthrin (cyano(4-fluoro-3-
phenoxyphenyl)methyl-3-(2,2-dicloroethenyl)-2,2-
dimethylcyclopropanecarboxylate) in or on the following food
commodities:
[[Page 18565]]
------------------------------------------------------------------------
Commodity Parts per million Expiration date
------------------------------------------------------------------------
Cottonseed oil........... 2.0............... Nov. 15, 1997
Tomato, concentrated 0.5............... Do.
products.
------------------------------------------------------------------------
(b) [Reserved]
* * * * *
PART 186--[AMENDED]
3. In part 186:
a. The authority citation for part 186 continues to read as
follows:
Authority: 21 U.S.C. 348.
b. In Sec. 186.1250, by revising paragraph (a) and removing
paragraph (b) and designating it as reserved, as follows:
Sec. 186.1250 Cyfluthrin.
(a) A tolerance, to expire on November 15, 1997, is established for
residues of the insecticide cyfluthrin (cyano[4-fluoro-3-
phenoxyphenyl]methyl-3-(2,2-dicloroethenyl)-2,2-
dimethylcyclopropanecarboxylate) in or on the following feed
commodities:
------------------------------------------------------------------------
Commodity Parts per million Expiration date
------------------------------------------------------------------------
Cottonseed, hulls........ 2.0............... November 15, 1997
Tomato, pomace (dry and 5.0............... Do.
wet).
------------------------------------------------------------------------
(b) [Reserved]
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[FR Doc. 95-9149 Filed 4-10-95; 1:53 pm]
BILLING CODE 6560-50-F