[Federal Register Volume 59, Number 38 (Friday, February 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4213]
[[Page Unknown]]
[Federal Register: February 25, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 0E3921/P576; FRL-4756-1]
RIN 2070-AC18
Pesticide Tolerance for Bifenthrin
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish a tolerance for residues of the
pesticide bifenthrin in or on the raw agricultural commodity dried
hops. The proposed regulation to establish a maximum permissible level
for residues of the pesticide was requested in a petition submitted by
the Interregional Research Project No. 4 (IR-4). This time-limited
tolerance would expire on November 15, 1994.
DATES: Comments, identified by the document control number [PP 0E3921/
P576], must be received on or before March 28, 1994.
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 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: Hoyt L. Jamerson,
Registration Division (7505W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St. SW., Washington, DC 20460.
Office location and telephone number: Sixth Floor, Crystal Station #1,
2800 Jefferson Davis Hwy., Arlington, VA 22202, (703) 308-8783.
SUPPLEMENTARY INFORMATION: The Interregional Research Project No. 4
(IR-4), New Jersey Agricultural Experiment Station, P.O. Box 231,
Rutgers University, New Brunswick, NJ 08903, submitted pesticide
petition (PP) 0E3921 and food additive petition (FAP) 0H5602 to EPA on
behalf of the Agricultural Experiment Stations of Idaho, Oregon, and
Washington. Pesticide petition 0E3921 requested that the Administrator,
pursuant to section 408(e) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e), establish a tolerance 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, in or on the raw agricultural
commodity green hops at 2 parts per million (ppm). Food additive
petition 0H5602 requested that the Administrator, pursuant to section
409 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 348,
establish a food additive regulation for residues of bifenthrin in or
on dried hops at 6 ppm.
IR-4 subsequently withdrew food additive petition 0H5602 and
revised pesticide petition 0E3921 by deleting the requested tolerance
for green hops and by requesting a pesticide tolerance, pursuant to
section 408(e) of the FFDCA, for residues of bifenthrin on the raw
agricultural commodity dried hops at 10 ppm. IR-4's withdrawal of the
food additive petition for dried hops and request for the establishment
of a pesticide tolerance for residues of bifenthrin on dried hops,
pursuant to section 408(e) of the FFDCA, was submitted in response to
EPA's revision of Subdivision O of the Pesticide Assessment Guidelines
that reclassified dried hops as a raw agricultural commodity (RAC).
This change was announced in PR Notice 93-12, which was issued on
December 23, 1993.
EPA has been considering for some time whether dried hops are
properly classified as a processed food. The FFDCA defines a RAC as
``food in its raw or natural state, including all fruits that are
washed, colored, or otherwise treated in their unpeeled natural form
prior to marketing.'' Elsewhere the FFDCA lists canning, cooking,
freezing, dehydration, and milling as examples of processing activities
for RACs.
Hops are a unique commodity, used almost exclusively as a flavoring
agent for beer. Harvested in a fresh form (green hops), they are
immediately dried in kilns. This on-farm drying is necessary to prevent
spoilage and always occurs prior to the shipment of the dried hops to
beer manufacturers. While the drying of hops is, in the most general
sense, a form of dehydration, both EPA and FDA have traditionally
treated many forms of dried or partially dried food as RACs, e.g.,
peanuts and grains. Hops growers, both domestic and international, have
asserted that dried hops should be considered a RAC because the drying
process takes place immediately upon harvest, before the hops leave the
farm or enter commerce, i.e., ``prior to marketing.''
Congress indicated in its most recent appropriations bill for EPA
that it believes that EPA's treatment of dried hops as a processed food
was a misinterpretation of the statute. That bill, Public Law 103-124,
which was signed by President Clinton on October 28, 1993, prohibits
EPA from using funds for any regulatory activity under FFDCA or FIFRA
that relates to hops as a processed food. In the Congressional report
that accompanied the bill (S. Rep. 103-137, 103d Cong., 1st Sess. 121
(1993)), the Appropriations Committee explained that this limitation on
spending was directed at barring EPA from acting on what Congress
believes is an erroneous interpretation of the term RAC as it applies
to dried hops. In consideration of these factors, EPA revised its
guidelines to change the classification of dried hops from a processed
commodity to a RAC. EPA requests comments on this change.
The scientific data submitted in the petition and other relevant
material have been evaluated. The toxicological data considered in
support of the proposed tolerance include:
1. A metabolism study in rats demonstrated that about 90 percent of
parent compound and its hydroxylated metabolites are excreted.
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 no developmental toxicity observed
under the conditions of the study. Maternal and fetal NOELs for this
study are established 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 support a low
level of concern for mutagenicity from 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 Effects 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:
a. Evidence for carcinogenicity was only observed in mice; no
compound related increases in tumors were observed in the
carcinogenicity study in rats.
b. It is unlikely that the hemangiopericytomas observed in the
mouse study were malignant.
c. Mutagenicity studies do not support Group B classification for
bifenthrin.
d. 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 dog feeding study,
which demonstrated intermittent tremors in test animals at the lowest
effect level, and an uncertainty factor of 100. The Theoretical Maximum
Residue Contribution (TMRC) from established tolerances utilizes 3.0
percent of the RfD for the U.S. population, or 3.2 percent of the RfD
if the tolerance for dried hops is granted. Established tolerances
utilize 10.2 percent of the RfD for non-nursing infants less than 1
year old, the subgroup with the highest estimated exposure to
bifenthrin residues. The proposed use on hops would not contribute to
the dietary exposure of non-nursing infants.
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.
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, Volume 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 any one
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.
The established meat and milk tolerances for bifenthrin, which are
time-limited tolerances established in support of conditional
registration for use of bifenthrin on cotton, are adequate to cover
secondary residues resulting from the proposed use of bifenthrin on
hops. On October 20, 1993, EPA granted a time extension for established
bifenthrin tolerances for cottonseed at 0.5 ppm, cattle, goat, sheep,
hog and horse fat, meat and meat byproducts at 0.1 ppm, and milk at
0.02 ppm. The meat and milk tolerances will expire on November 15,
1994. The proposed tolerances for dried hops would expire on November
15, 1994, to coincide with the expiration date for bifenthrin meat and
milk tolerances. In the event that the Agency establishes the proposed
tolerance for dried hops and subsequently establishes permanent
bifenthrin tolerances for meat and milk, the tolerance for dried hops
would be reassessed and, if appropriate, the Agency would propose that
a permanent tolerance be established for this commodity.
Based on the information and data considered, the Agency has
determined that the tolerance established by amending 40 CFR part 180
would protect the public health. Therefore, it is proposed that the
tolerance 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/P576]. 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: February 9, 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 Bifenthrin; tolerances for residues.
Tolerances, to expire on November 15, 1994, 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
Commodity million
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Cottonseed................................................. 0.5
Hops, dried................................................ 10.0
Meat, fat, and meat byproducts of cattle, goats, hogs,
horses, and sheep......................................... 0.1
Milk....................................................... 0.02
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[FR Doc. 94-4213 Filed 2-24-94; 8:45 am]
BILLING CODE 6560-50-F