[Federal Register Volume 60, Number 128 (Wednesday, July 5, 1995)]
[Proposed Rules]
[Pages 34943-34945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16429]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 5E4425/P619; FRL-4962-5]
RIN 2070-AC18


Imidacloprid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to establish a tolerance for residues of the 
insecticide (1-[6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine (referred to in this document as imidacloprid) and 
its metabolites in or on the raw agricultural commodity dried hops. The 
Interregional Research Project No. 4 (IR-4) requested pursuant to the 
Federal Food, Drug and Cosmetic Act (FFDCA) the proposed regulation to 
establish a maximum permissible level for residues of the insecticide.

DATES: Comments identified by the document control number, [PP 5E4425/
P619], must be received on or before August 4, 1995..

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 Highway, 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 should not be submitted 
through e-mail. Information marked as CBI 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 4:30 p.m., Monday through Friday, excluding legal 
holidays.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect 5.1 file format or ASCII file format. 
All comments and data in electronic form must be identified by the 
docket number [PP 5E4425/P619]. Electronic comments on this proposed 
rule may be filed online at many Federal Depository Libraries. 
Additional information on electronic submissions can be found in the 
``SUPPLEMENTARY INFORMATION'' section of this document.

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 Highway, Arlington, VA 22202, (703)-308-8783; e-
mail: [email protected].

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, has submitted pesticide 
petition (PP) 5E4425 to EPA on behalf of the Agricultural Experiment 
Stations of Oregon and Washington. This petition requests that the 
Administrator, pursuant to section 408(e) of the Federal Food, Drug, 
and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), amend 40 CFR 180.472 by 
establishing a tolerance for residues of the insecticide imidacloprid 
(1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-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 raw agricultural commodity dried hops at 6 parts per million (ppm).
    In the Federal Register of June 28, 1994 (59 FR 33204), EPA 
established a time-limited tolerance for residues of imidacloprid on 
dried hops at 3.0 ppm. The imidacloprid tolerance for dried hops was 
established to expire on June 28, 1995, to allow IR-4 sufficient time 
to conduct additional residue field trials in support of a permanent 
tolerance for this use. Subsequently, IR-4 submitted the data from the 
residue field trials and petition 5E4425 in support of a permanent 
tolerance, but EPA extended the time-limited tolerance to expire on 
June 28, 1996 (60 FR 24784, May 10, 1995), when it became apparent that 
the IR-4 proposed tolerance could not be established prior to the June 
28, 1995 expiration date. The IR-4 residue data have been reviewed and 
determined to be adequate to support a permanent tolerance for 
imidacloprid on dried hops at 6 ppm.
    The toxicological data considered in support of the proposed 
tolerance include:
    1. A 1-year chronic feeding study in dogs fed diets containing 0, 
200, 500, or 1,250/2,500 ppm (average intake was 0, 6.1, 15, or 41/72 
milligrams (mg)/kilogram (kg)/day) with a noobserved-effect level of 
1,250 ppm based on increased plasma cholesterol and liver cytochrome P-
450 levels in dogs at the 2,500-ppm dose level. The high dose was 
increased to 2,500 ppm (72 mg/kg/day) from week 17 onward due to lack 
of toxicity at the 1,250-dose level.
    2. A 2-year feeding/carcinogenicity study in rats fed diets 
containing 0, 100, 300, 900, or 1,800 ppm with a NOEL for chronic 
effects at 100 ppm (5.7 mg/kg/day in males, 7.6 mg/kg/day in females) 
that included decreased body weight gain in females at 300 ppm (24.9 
mg/kg/day) and above; and increased thyroid 

[[Page 34944]]
lesions in males at 300 ppm (16.9 mg/kg/day) and above, and in females 
at 900 ppm (73 mg/kg/day) and above. There were no apparent 
carcinogenic effects under the conditions of the study.
    3. A 2-year carcinogenicity study in mice fed diets containing 0, 
100, 330, 1,000, or 2,000 ppm with a NOEL of 1,000 ppm (208 mg/kg/day 
in males, 274 mg/kg/day in females) based on decreased food consumption 
and decreased water intake at the 2,000-ppm dose level. There were no 
apparent carcinogenic effects observed under the conditions of this 
study.
    4. A three-generation reproduction study with rats feed diets 
containing 0, 100, 250, or 700 ppm with a reproductive no-observed-
effect level (NOEL) of 100 ppm (equivalent to 8 mg/kg/day based on 
decreased pup body weight observed at the 250-ppm dose level.
    5. A developmental toxicity study in rat given gavage doses at 0, 
10, 30, or 100 mg/kg/day during gestation days 6 to 16 with a NOEL for 
developmental toxicity at 30 mg/kg/day based on increased wavy ribs 
observed at the 100 mg/kg/day dose level.
    6. A developmental toxicity study in rabbits given gavage doses at 
0, 8, 24, or 72 mg/kg/day during gestation days 6 through 19 with a 
NOEL for developmental toxicity at 24 mg/kg/day based on decreased body 
weight and increased skeletal abnormalities observed at the 72 mg/kg/
day dose level.
    7. Imidacloprid, which was tested in a battery of 23 mutagenic 
assays, was negative for mutagenic effects in all but two of the 
assays. Imidacloprid tested positive for chromosome aberrations in an 
in vitro cytogenetic study with human lymphocytes for the detection of 
induced clastogenic effects, and for genotoxicity in an in vitro 
cytogenetic assay measuring sister chromatid exchange in Chinese 
hamster ovary cells.
    Dietary risk assessments for imidacloprid indicate that there is 
minimal risk from established tolerances and the proposed tolerance for 
dried hops. A cancer risk assessment is not appropriate for 
imidacloprid since the pesticide is assigned to ``Group E'' (evidence 
of noncarcinogenicity for humans) of EPA's cancer classification 
system. Dietary risk assessments for the pesticide were conducted using 
the Reference Dose (RfD) to assess chronic exposure and risk and the 
Margin of Exposure (MOE) for acute toxicity.
    The RfD is calculated at 0.057 mg/kg/of body weight/day based on a 
NOEL of 5.7 mg/kg/day from the 2-year rat feeding/carcinogenicity study 
and 100-fold uncertainty factor. The theoretical maximum residue 
contribution (TMRC) from existing tolerances and the proposed tolerance 
for dried hops utilizes less than 5 percent of the RfD for the general 
population and 26 percent of the RfD for nonnursing infants less than 
one year in age.
    The MOE is a measure of how closely the high end acute dietary 
exposure comes to the no-observed-effect level from the toxicity 
endpoint of concern. For imidacloprid the MOE was calculated as a ratio 
of the NOEL (24 mg/kg/day) from the rabbit developmental toxicity study 
to dietary exposure, as estimated for the population subgroup at 
greatest risk (females of childbearing age). The MOE for this subgroup 
is estimated at 2500 for high-end exposure. Acute dietary margins of 
exposure of less than 100 are generally of concern to EPA. A MOE of 
2,500 poses minimal risk.
    Established tolerances for meat, milk, poultry, and eggs are 
adequate to cover secondary residues resulting from the feeding of 
spent hops to livestock.
    The metabolism of imidacloprid in plants and animals is adequately 
understood. An adequate analytical method is available for enforcement 
purposes. The enforcement method 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 method is being made available in 
the interim to any one interest 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., SW., Washington, DC 20460. 
Office location and telephone number: Rm. 1130A, CM #2, 1921 Jefferson 
Davis Hwy., Arlington, VA 22202, (703)-305-5937.
    There are currently no actions pending against the continued 
registration of this chemical.
    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 notice in the Federal Register that this rulemaking proposal be 
referred to an Advisory Committee in accordance with section 408(e) of 
the FFDCA.
    A record has been established for this rulemaking under docket 
number [PP 5E4425/P619] (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. 
The public record is located in Rm. 1132 of the Public Response and 
Program Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 
1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:
    opp-D[email protected]
    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer all comments received electronically into printed, 
paper form as they are received and will place the paper copies in the 
official rulemaking record which will also include all comments 
submitted directly in writing. The official rulemaking record is the 
paper record maintained at the address in ``ADDRESSES'' at the 
beginning of this document.
    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 

[[Page 34945]]
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: June 23, 1995.

Peter Caulkins,

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. In Sec. 180.472, paragraph (a) is amended in the table therein 
by adding and alphabetically inserting dried hops, and paragraph (d) is 
removed, as follows:


Sec. 180.472   1-[(6-Chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine; tolerances for residues.

    (a) *  *  *

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                                                              Parts per 
                         Commodity                             million  
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                  *        *        *        *        *                 
Hops, dried................................................            6
                                                                        
                  *        *        *        *        *                 
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[FR Doc. 95-16429 Filed 7-3-95; 8:45 am]
BILLING CODE 6560-50-F