[Federal Register Volume 59, Number 119 (Wednesday, June 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15084]
[[Page Unknown]]
[Federal Register: June 22, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 7F3546/P584; FRL-4869-1]
RIN 2070-AC18
Bifenthrin; Pesticide Tolerances and Extension of 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 bifenthrin in or on the raw agricultural commodities (RACs)
corn (field, seed, and pop) grain, silage (forage), stover (fodder),
milk, milk fat, meat, fat, and meat byproducts of cattle, goats, hogs,
horses, sheep, and poultry and eggs. The proposed regulation to
establish maximum permissible levels for residues of the pesticide in
or on these commodities was requested in a petition submitted by FMC
Corp. EPA also proposes to extend tolerances for the residues of
bifenthrin in or on cottonseed.
DATES: Comments, identified by the document control number, [PP 7F3546/
P584] must be received on or before July 22, 1994.
ADDRESSES: By mail, submit written comments and hearing requests to:
Public Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Rm. M3708, 401 M St., SW., Washington, DC 20460. In person, bring
objections and hearing requests to: Rm. 1128, 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 (7505W), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Second Floor, Crystal
Mall #1, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-
6100.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of November 25, 1987 (52 FR 45237), which announced
that FMC Corp., 1735 Market St., Philadelphia, PA 19103, had submitted
pesticide petition (PP) 7F3546 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 part 180 by establishing
tolerances for residues of the pesticide bifenthrin, (2-methyl [1,1'-
biphenyl]-3-yl)methyl-3-(2-chloro-3,3,3,-trifluoro-1-propenyl)-2,2-
dimethylcyclopropanecarboxylate, and its 4'-hydroxy metabolite in or on
the raw agricultural commodities corn (field, seed, and pop) grain at
0.05 part per million (ppm), forage at 2.0 ppm, fodder at 4.0 ppm, milk
at 0.02 ppm, milk fat at 0.20 ppm, meat at 0.10 ppm, fat at 0.30 ppm,
and meat byproducts of goats, hogs, horses, and sheep at 0.10 ppm.
At the request of FMC Corp., EPA issued an amended notice published
in the Federal Register of August 4, 1993 (58 FR 41473), proposing that
tolerances be established as follows: Corn (field, seed, and pop) grain
at 0.05 ppm (No detectable residues were found in grain at exaggerated
rates, and the proposed tolerance is based on method sensitivity),
silage (fodder) combined residue of bifenthrin plus 4'-OH bifenthrin at
2.0 ppm, stover (fodder) for the combined residue of bifenthrin plus
4'-OH bifenthrin at 5.0 ppm; milk, fat at 1.0 ppm (reflecting 0.1 ppm
in whole milk); meat of cattle, goats, hogs, horses, and sheep at 0.05
ppm; fat of cattle, goats, hogs, horses, and sheep at 1.0 ppm; and meat
byproducts of cattle, goats, hogs, horses, and sheep at 0.10 ppm.
On September 8, 1993, FMC Corp. requested that the pesticide
petition be amended by proposing that tolerances be established in/on
meat, fat, and meat byproducts of poultry and eggs at 0.05 ppm and by
deleting the 4'-hydroxy metabolite from the tolerance expression. This
amendment was submitted in response to EPA's conclusion that although
residues in poultry from existing and proposed uses are expected to be
nondetectable, tolerances should be set at the limit of quantitation
and that the residue to be regulated is bifenthrin per se and not the
4'hydroxy metabolite.
The scientific data submitted in the petition and other relevant
material have been evaluated. The toxicological data considered in
support of the proposed tolerances include:
1. Metabolism studies in rats with single doses of 4 and 35 mg/kg
demonstrate that about 90 percent of parent compound and its
hydroxylated metabolites are excreted. With doses of 0.5 mg/kg/day,
significant bioaccumulation of the parent compound can occur in tissues
with high fat content, with half-lives in these tissues of about 50
days.
2. A 12-month feeding study in dogs fed dose levels of 0, 0.75,
1.5, 3.0, or 5.0 milligrams(mg)/kilogram (kg)/day with a no-observed-
effect level (NOEL) of 1.5 mg/kg/day. The lowest-effect level (LEL) for
this study is established at 3.0 mg/kg/day based on the occurrence of
intermittent tremors in the test animals.
3. A developmental toxicity study in rats given gavage doses of 0,
0.5, 1.0, or 2.0 mg/kg/day with maternal and fetal NOELs at 1.0 mg/kg/
day. The maternal NOEL is based on the occurrence of tremors, and the
fetal NOEL is based on an increased incidence of hydroureter without
hydronephrosis at the 2.0-mg/kg/day dosage level.
4. A developmental toxicity study in rabbits given gavage doses of
0, 2.67, 4, or 8 mg/kg/day with no developmental toxicity observed
under the conditions of the study. The maternal NOEL is established at
4 mg/kg/day based on the occurrence of twitching and tremors at the 8
mg/kg/day dosage level.
5. A two-generation reproduction study in rats fed diets containing
0, 30, 60, or 100 ppm with no reproductive effects or developmental
toxicity observed under the conditions of the study. The maternal NOEL
for the study is established at 30 ppm (equivalent to 5 mg/kg/day)
based on lower body weight in females.
6. Mutagenicity tests, including gene mutation in Salmonella,
chromosomal aberrations in Chinese hamster ovary and rat bone marrow
cells, HGPRT locus mutation in mouse lymphoma cells, and unscheduled
DNA synthesis in rat hepatocytes, were all negative. Bifenthrin was
marginally active in a forward mutation test involving the thymidine
kinase locus in mouse lymphoma cells. These test results indicate a low
mutegenic potential for bifenthrin.
7. A 24-month feeding/carcinogenicity study with rats fed diets
containing 0, 12, 50, 100, or 200 ppm with a systemic NOEL of 50 ppm
(equivalent to 2.5 mg/kg/day) based on tremors, elevated body weight,
and higher liver and kidney organ-to-body weight ratios. There were no
carcinogenic effects observed under the conditions of the study.
8. A carcinogenicity study with mice fed diets containing 0, 50,
200, 500, or 600 ppm (equivalent to 7.5, 30, 75, or 90 mg/kg/day) for
87 weeks (males) and 92 weeks (females) with a statistically
significant trend for hemangiopericytomas of the urinary bladder of
male mice. In this study, male mice in the high-dose group (600 ppm)
showed an increase in the number of hemangiopericytomas of the urinary
bladder as compared to the control group. Although the number of
hemangiopericytomas was twice as high in male mice at the high dose
level compared to the control animals, the difference in rate of tumors
between the control group and the high-dose group was not statistically
significant by pair-wise comparison. There were also significant dose-
related trends in hepatocellular carcinomas and in the combined
hepatocellular adenomas and/or carcinomas in male mice. Female mice had
significantly higher incidences of combined lung adenomas and
carcinomas in the 50, 200, and 600 ppm groups, although there was no
significant dose-related trend.
Bifenthrin has been classified by the Office of Pesticide Programs'
Health Effect's Division's Carcinogenicity Peer Review Committee (CPRC)
as a Group C carcinogen, i.e., possible human carcinogen. The Agency
has chosen to use the reference dose calculations to estimate human
dietary risk from bifenthrin residues. The decision supporting
classification of bifenthrin as a possible carcinogen (Group C) rather
than a probable carcinogen (Group B) was primarily based on the
following:
1. Evidence for carcinogenicity was only observed in mice; no
compound- related increases in tumors were observed in the
carcinogenicity study in rats.
2. It is unlikely that the hemangiopericytomas observed in the
mouse study were malignant.
3. Mutagenicity studies do not support Group B classification for
bifenthrin.
4. Feeding studies using structurally related pyrethroids, which
were classified as Group C carcinogens by the CPRC, have resulted in
increased incidences of lung tumors in female mice.
A dietary exposure/risk assessment was performed for bifenthrin
using a Reference Dose (RfD) of 0.015 mg/kg of body weight/day. The RfD
is based on an NOEL of 1.5 mg/kg/day from the 1-year feeding study in
dogs, which demonstrated intermittent tremors in test animals at the
lowest effect level, and an uncertainty factor of 100. The current
estimated dietary exposure for the overall U.S. population resulting
from established tolerances is 0.000385 mg/kg bwt/day, which represents
2.6 percent of the RfD. The current action will increase exposure to
0.001935 mg/kg bwt/day or 12.9 percent of the RfD. In the subgroup
population exposed to the highest risk, nonnursing infants less than 1
year old, the current action would increase exposure to 0.007404 mg/kg
bwt/day or 49.4 percent 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 bifenthrin, as
estimated by the dietary risk assessment, does not appear to be of
concern. The cancer risk to humans is considered negligible, given the
weight of evidence considerations, which only support the
classification of bifenthrin as a possible carcinogen, and the low
level of exposure to bifenthrin residues in the human diet.
The metabolism of the chemical in plants and animals for this use
is adequately understood. Although a processing study shows some
concentration of bifenthrin residues in corn oil, EPA has determined
that a section 409 food additive regulation is unnecessary because it
is unlikely that the bifenthrin residues in corn oil will exceed the
limit of quantification tolerance that is being established for
bifenthrin in corn grain. Analysis of the field trial data indicates
that bifenthrin residue levels in corn grain will be lower than the
grain tolerance by a factor greater than the concentration factor.
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 bifenthrin 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 of October 20, 1993 (58 FR 54094) and February 22, 1994 (59
FR 9411)). On November 15, 1993, EPA amended the registration on
cottonseed by extending the expiration date to November 15, 1996. The
registration was amended and extended to allow time for submission and
evaluation of additional environmental effects data. In order to
evaluate the effects of bifenthrin 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 extension issued for
the conditional registration, the Agency is proposing to extend the
tolerance on cottonseed and other commodities, and establish a time-
limited tolerance on corn (field, seed, and pop) with an expiration
date of November 15, 1997, to cover residues expected to result from
use during the period of conditional registration.
The pesticide is considered useful for the purposes for which it is
sought. Based on the information and data considered, the Agency
concludes that the proposed section 408 tolerances and extension will
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 0E3921/P584]. 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 Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 2, 1994.
Stephen L. Johnson,
Acting 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 revising Sec. 180.442, to read as follows:
Sec. 180.442 Bifentrhin; tolerances for residues.
Tolerances, to expire on November 15, 1997, are established for
residues of the pyrethroid bifenthrin, (2-methyl [1,1'-biphenyl]-3-
yl)methyl-3-(2-chloro-3,3,3-trifluoro-1-propenyl)-2,2-
dimethylcyclopropanecarboxylate, in or on the following commodities:
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Parts per
Commodities million
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Cattle, fat................................................ 1.0
Cattle, meat............................................... 0.5
Cattle, mbyp............................................... 0.10
Corn, forage............................................... 2.0
Corn, fodder............................................... 5.0
Corn, grain (field, seed, and pop)......................... 0.05
Cottonseed................................................. 0.5
Eggs....................................................... 0.05
Goats, fat................................................. 1.0
Goats, meat................................................ 0.5
Goats, mbyp................................................ 0.10
Hogs, fat.................................................. 1.0
Hogs, meat................................................. 0.5
Hogs, mbyp................................................. 0.10
Hops, dried................................................ 10.0
Horses, fat................................................ 1.0
Horses, meat............................................... 0.5
Horses, mbyp............................................... 0.10
Milk, fat (reflecting 0.1 ppm in whole milk)............... 1.0
Poultry, fat............................................... 0.05
Poultry, meat.............................................. 0.05
Poultry, mbyp.............................................. 0.05
Sheep, fat................................................. 1.0
Sheep, meat................................................ 0.5
Sheep, mbyp................................................ 0.10
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[FR Doc. 94-15084 Filed 6-21-94; 8:45 am]
BILLING CODE 6560-50-F
