Bifenthrin - Proposed Pesticide Tolerances 2/94
40 CFR Part 180
[PP 0E3921/P576; FRL-4756-1]
Pesticide Tolerance for Bifenthrin
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
40 CFR Part 180
[PP 0E3921/P576; FRL-4756-1]
Pesticide Tolerance for Bifenthrin
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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
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-
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
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,
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
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
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
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
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
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
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
Dated: February 9, 1994.
Stephen L. Johnson,
Acting Director, Registration Division, Office of Pesticide
Therefore, it is proposed that 40 CFR part 180 be amended
1. The authority citation for part 180 continues to read
Authority: 21 U.S.C. 346a and 371.
2. By revising . 180.442, to read as follows:
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]-
in or on the following commodities:
Commodity | Parts per
Cottonseed................................................... | 0.5
Hops, dried.................................................. | 10.0
Meat, fat, and meat byproducts of cattle, goats, hogs, horses,| 0.1
and sheep. |
Milk......................................................... | 0.02
[FR Doc. 94-4213 Filed 2-24-94; 8:45 am]