[Federal Register Volume 60, Number 35 (Wednesday, February 22, 1995)]
[Proposed Rules]
[Pages 9815-9816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4185]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300379; FRL-4934-8]
RIN 2070-AC18
Extended Tolerance on Dried Hops for Imidacloprid
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to extend the tolerance for residues of the
insecticide 1-[(6-chloro-3-pyridinyl) methyl]-N-nitro-2-
imidazolidinimine and its metabolites (common name ``imidacloprid'') in
or on dried hops at 3.0 parts per million (ppm). On its own
inititative, EPA proposes to extend the tolerance to allow time to
review a petition from the Interregional Research Project No. 4 (IR-4).
DATES: Written comments, identified by the document control number,
[OPP-300379], may be submitted on or before March 24, 1995.
ADDRESSES: Comments may be submitted to: Public Docket and Freedom of
Information Section, Field Operations Division (7506C), Office of
Pesticide Programs, 401 M St., SW., Washington, DC 20604. In person,
bring comments to: Rm. 1132, CM #2, Arlington, VA 22202.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information
``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 below, from 8 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Dennis H. Edwards, Jr.,
Product Manager (PM) 19, Registration Division (7505C), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 207, CM #2, 1921 Jefferson Davis
Hwy., Arlington, VA 22202, (703)-305-6386.
SUPPLEMENTARY INFORMATION: On its own initiative and pursuant to
section 408(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(e), the Agency established in 40 CFR 180.472 a time-limited
tolerance for the residues of imidacloprid on dried hops at 3.0 parts
per million (ppm) (see the Federal Register of June 28, 1994 (59 FR
33204)). EPA established this tolerance because EPA had granted a
petition for an emergency exemption under section 18 of the Federal
Insecticide, Fungicide and Rodenticide Act, 7 U.S.C. 136p, for the use
of imidacloprid on hops in the States of Washington, Oregon, and Idaho;
imidacloprid is used in other countries which export hops to the United
States; and the database for imidacloprid is relatively complete. At
that time, a third field residue trial was outstanding. Since then, the
Interregional Research Project No. 4 (IR-4) has submitted a pesticide
petition to the Agency requesting that a tolerance be established in or
on dried hops. This petition is currently in review. The Agency may not
complete its review of the IR-4 petition before the time-limited
tolerance would expire. EPA does not believe that its risk assessment
will significantly change as a result of the IR-4 petition. Therefore,
the Agency is proposing to extend this tolerance for an additional 1-
year period, i.e., to June 28, 1996.
In the Federal Register of November 30, 1994 (59 FR 61278), EPA
revised 40 CFR 180.472 and removed the time-limited designation for
commodities listed in paragraph (a). The listing for ``Hops, dried'' at
3.0 ppm inadvertently was left in paragraph (a) in the new list of
commodities without a time-limited designation. Hops should have
retained the time-limited designation, June 28, 1995, and been moved to
a new paragraph. This change was made by a technical amendment
published in the Federal Register of February 22, 1995.
All relevant materials have been evaluated. The toxicology data
considered in support of the tolerance include:
1. A three generation rat reproduction study that showed a NOEL of
100 ppm (8 mg/kg/bwt); rat and rabbit teratology studies were negative
at doses up to 30 mg/kg/bwt and 24 mg/kg/bwt, respectively.
2. A 2-year rat feeding/carcinogenicity study that was negative for
carcinogenic effects under the conditions of the study and had a NOEL
of 100 ppm (5.7 mg/kg/bwt in males and 7.6 mg/kg/bwt in females) for
noncarcinogenic effects, which included decreased body weight gain in
females at 300 ppm and increased thyroid lesions in males at 300 ppm
and females at 900 ppm.
3. A 1-year dog feeding study that showed a NOEL of 1,250 ppm (41/
mg/kg/bwt).
4. A 2-year mouse carcinogenicity study that was negative for
carcinogenic effects under the conditions of the study and had a NOEL
of 1,000 ppm (208 mg/kg/day).
There is no cancer risk associated with exposure to this chemical.
Imidacloprid has been classified as a ``Group E'' (no evidence of
carcinogenicity for humans) carcinogen by the OPP Reference Dose (RfD)
Committee.
The reference dose (RfD), based on the 2-year rat feeding/
carcinogenic study with a NOEL of 5.7 mg/kg/bwt and 100-fold
uncertainty factor, is calculated to be 0.057 mg/kg/bwt. The
theoretical maximum residue contribution (TMRC) from the proposed
tolerances is 0.000984 mg/kg/bwt/day and utilizes 2% percent of the
ADI.
The nature of the residue in plants and livestock is adequately
understood. Spent hops are not considered a poultry feed item;
therefore, secondary imidacloprid tolerances for poultry and eggs are
not required. The analytical method is a common moiety method for
imidacloprid and its metabolites containing the 6-chloropyridinyl
moiety in plants using a permanganate oxidation, silyl derivatization,
and capillary GC-MS-selective ion monitoring. The magnitude of the
residue crop field trial data for imidacloprid on hops indicates that
residues of total imidacloprid will not exceed the proposed tolerance
when the formulations are used as directed. The extension for this use
will expire on June 28, 1996.
This pesticide is considered useful for the purposes for which the
tolerances are sought. Based on the above information considered by the
Agency, 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 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 [[Page 9816]] that this rulemaking proposal be
referred to an Advisory Committee in accordance with FFDCA section
408(e).
Interested person are invited to submit written comments on the
proposed regulation. Comments must bear notation indicating the
document control number, [OPP-300379]. All written comments filed in
response to this document will be be available in the Public Docket and
Freedom of Information Section, at the addressed given above from 8
a.m. to 4 p.m, Monday through Friday, except legal holidays.
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 exemption 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
Administrative practice and procedure, Agricultural commodities,
Pesticides and pests, Reporting and recordkeeping requirements.
Dated: February 10, 1995.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that chapter I of title 40 of the Code of
Federal Regulations be amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to as follows:
Authority: 21 U.S.C. 346a and 371.
2. In 180.472, by revising paragraph (d), to read as follows:
Sec. 180.472 1-[(6-Chloro-3-pyridinyl) methyl]-N-nitro-2-
imidazolidinimine; tolerances for residues.
* * * * *
(d) A time-limited tolerance, to expire June 28, 1996, is
established permitting the combined residues of the insecticide 1-[(6-
chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine and its
metabolites containing the chloropyridinyl moiety, all expressed as 1-
[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine, in or on
the following raw agricultural commodity:
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Parts per
Commodity million
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Hops, dried................................................ 3.0
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[FR Doc. 95-4185 Filed 2-21-95; 8:45 am]
BILLING CODE 6560-50-F
