[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:

------------------------------------------------------------------------
                                                              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