[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:

------------------------------------------------------------------------
                                                              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