[Federal Register Volume 59, Number 93 (Monday, May 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11827]
[[Page Unknown]]
[Federal Register: May 16, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300343; FRL-4866-7]
RIN No. 2070-AC18
Pesticide Tolerances for 1-[(6-Chloro-3-Pyridinyl)Methyl]-N-
Nitro-2-Imidazolidinimine
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes to establish time-limited tolerances
for residues of the insecticide 1-[(6-chloro-3-pyridinyl)methyl]-N-
nitro-2-imidazolidinimine and its metabolites (proposed common name
``imidacloprid'') in or on dried hops at 3.0 parts per million (ppm),
milk at 0.05 ppm, and meat, fat, and meat byproducts of cattle, goats,
hogs, horses, and sheep at 0.2 ppm, with an expiration date of 1 year
after the beginning of the effective date of a final rule based on this
proposal. EPA is issuing this proposal on its own initiative.
DATES: Comments, identified by the document control number, [OPP-
300343], must be recieved on or before June 15, 1994.
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. 1128, 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 the EPA without prior notice.
All written comments will be available for public inspection in Rm.
1128 at the address given below, from 8 a.m. to 4 p.m., Monday through
Friday, excluding 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), EPA is proposing a time-limited tolerance for the
residues of imidacloprid on dried hops at 3.0 parts per million (ppm).
EPA recently reclassified dried hops as raw agricultural commodity (59
FR 9167; Feb. 25, 1994 and 59 FR 17487; April 13, 1994). EPA is
proposing the tolerance because EPA has 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 that export hops to the United
States; and the database for imidacloprid is relatively complete. The
most significant data gap for establishing a permanent tolerance for
imidacloprid on dried hops is a third field-residue trial. Given the
relatively low risks presented by imidacloprid, EPA does not believe
that the missing data will significantly change EPA's risk assessment.
Nevertheless, EPA is establishing a 1-year time limitation on this
tolerance for a full residue data base to be available in making a
decision on a permanent tolerance.
All relevant materials have been evaluated. The toxicology data
considered in support of the tolerance include:
1. A three-generation rat reproduction study with a no-observed-
effect level (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 male and 7.6 mg/kg/bwt female) for
noncarcinogenic effects that 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 with 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 that 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
uncertainity 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 percent of
the ADI.
The nature of the residue in plants and livestock is adequately
understood. Results of a bovine feeding study show that finite
imidacloprid residues will actually occur in milk, meat, fat, and meat
by-products of cattle, goats, hogs, horses, and sheep from feeding of
imidacloprid-treated raw agricultural commodities or their processed
commodities when the formulations are used as directed; therefore,
tolerances are required. 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-chloropyridiyl 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 indicate that residues
of total imidacloprid will not exceed the proposed tolerance when the
formulations are used as directed.
The tolerance would be established for 1 year, with an expiration
date of 1 year after the beginning of the effective date of a final
rule based on this proposal.
This pesticide is considered useful for the purposes for which the
tolerances are sought. Based on the above information considered by the
Agency, the tolerances established by amending 40 CFR part 180 would
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 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 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-300343]. 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 exemptions from tolerance
requirements do not have a significant economic impact on a substantial
number of small entities. A certification statement of this effect was
published in the Federal Register of May 4, 9181 (46 FR 24950).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Recording and
recordkeeping requirements.
Dated: May 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 as follows:
Authority: 21 U.S.C. 346a and 371.
b. By adding new 180.472, to read as follows:
Sec. 180.472 1-[(6-Chloro-3-pyridinyl) methyl]-N-2-imidazolidinimine;
tolerances for residues.
Time-limited tolerances, to expire (1 year after beginning of
effective date of final rule), are established permitting the combined
residues of the insecticide 1-[(6-chloro-3-pyridinyl) methyl]-N-2-
imidazolidinimine and its metabolites containing the 6-chloropyridinyl
moiety, all expressed as 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine, in or on the following raw agricultural commodities:
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Parts per
Commodity million
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Cattle, fat................................................ 0.2
Cattle, meat............................................... 0.2
Cattle, meat byproducts.................................... 0.2
Hops, dried................................................ 3.0
Goats, fat................................................. 0.2
Goats, meat................................................ 0.2
Goats, meat byproducts..................................... 0.2
Hogs, fat.................................................. 0.2
Hogs, meat................................................. 0.2
Hogs, meat byproducts...................................... 0.2
Horses, fat................................................ 0.2
Horses, meat............................................... 0.2
Horses, meat byproducts.................................... 0.2
Milk....................................................... 0.05
Sheep, fat................................................. 0.2
Sheep, meat................................................ 0.2
Sheep, meat byproducts..................................... 0.2
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[FR Doc. 94-11827 Filed 5-11-94; 12:37 pm]
BILLING CODE 6560-50-F
