40 CFR Part 180

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