[Federal Register Volume 60, Number 239 (Wednesday, December 13, 1995)]
[Proposed Rules]
[Pages 64006-64009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30372]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 5E4598/P638; FRL-4990-5]
RIN 2070-AC18


Imidacloprid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to establish a time-limited tolerance for 
indirect or inadvertent combined residues of the insecticide (1-[6-
chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine (referred to in 
this document as imidacloprid) and its metabolites resulting from crop 
rotational practices in or on the raw agricultural commodities in the 
cucurbit vegetables crop group. The proposed regulation to establish a 
maximum permissible level for residues of the insecticide was requested 
in a petition submitted by the Interregional Research Project No. 4 
(IR-4) pursuant to the Federal Food, Drug and Cosmetic Act (FFDCA). The 
time-limited tolerance would expire on December 31, 1996.

DATES: Comments, identified by the document control number [PP 5E4598/
P638], must be received on or before January 12, 1996.

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 22202. 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 

[[Page 64007]]
comments and data in electronic form must be identified by the docket 
number [PP 5E4425/P638]. Electronic comments on this proposed rule may 
be filed online at many Federal Depository Libraries. Additional 
information on electronic submissions can be found below in this 
document.
    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.

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) 5E4598 to EPA on behalf of the Agricultural Experiment 
Stations of California, Florida, Georgia, South Carolina, and Texas. 
The 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 indirect 
or inadvertent, combined 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, 
resulting from crop rotational practices in or on the raw agricultural 
commodities in the cucurbit vegetables crop group at 0.2 part per 
million (ppm).
    The proposed tolerance will not support registration for 
imidacloprid on cucurbit vegetables. EPA will not consider applications 
for section 3 or section 24(c) registration of imidacloprid on cucurbit 
vegetables based the proposed time-limited tolerance. The tolerance 
would allow growers to produce cucurbit vegetables in rotation with 
crops that are treated in accordance with registered uses of 
imidacloprid. Imidacloprid registrations prohibit growers from planting 
crops which lack an imidacloprid tolerance on ground treated with the 
insecticide within a 12-month period. In some areas, however, it is a 
common practice for growers to plant back cucurbit vegetables (melons, 
squash, and cucumbers) in fields that have been used to produce 
tomatoes and peppers. Imidacloprid is registered and tolerances are 
established for the fruiting vegetables crop group (including tomatoes 
and peppers). There are no established imidacloprid tolerances, 
however, for the cucurbit vegetables. Crop rotational studies reviewed 
by EPA indicate that plant-back crops grown in fields treated with 
imidacloprid may contain measurable amounts of the pesticide residue, 
if the rotational crop is planted within 12 months of application of 
the pesticide.
    Currently, growers who plan to double crop with cucurbit vegetables 
must not use imidacloprid, or they must not plant back cucurbit 
vegetables in fields treated within 12 months of application with 
imidacloprid. According to the University of Florida Cooperative 
Extension Service, the inability to double crop because of the 
imidacloprid plant-back restriction will have a serious financial 
impact on the South Florida vegetable industry. Approximately 12,000 
acres in South Florida are double cropped with cucurbit vegetables. 
Much of this acreage has been treated with imidacloprid to control 
sweet potato whitefly (silverleaf whitefly) on tomatoes. Prior to 
registration of imidacloprid on tomatoes, EPA approved emergency 
exemptions under Section 18 of Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) for its use in California, Florida, South 
Carolina, and Texas to avert significant economic loss from sweet 
potato white fly damage.
    The proposed tolerance, which would expire on December 31, 1996, 
should allow IR-4 sufficient time to submit a permanent tolerance for 
imidacloprid on cucurbit vegetables. IR-4 is developing field residue 
data in support of a permanent tolerance and registration for use of 
imidacloprid on cucurbit vegetables. The permanent tolerance will be 
proposed by IR-4 to cover residues in cucurbit vegetables from 
application to the growing crop, as well as crop rotational practices.
    EPA's policy is to consider tolerance petitions, when requested by 
the registrants or any interested parties, for pesticide residues on 
replacement or rotational crops when residues result from pesticide 
carryover in soil from treatment of previous crops. Such tolerances 
will be set at levels determined to be appropriate based on evaluations 
of toxicity and residue data submitted to the Agency by the petitioner. 
Guidance on how to conduct residue studies on rotation crops can be 
found in the EPA publication ``Pesticide Reregistration Reject Rate 
Analysis Residue Chemistry/Environmental Fate Follow Up Guidance for 
Conducting Rotational Crop Studies,'' February 1993. The procedures for 
filing a petition, as described in 40 CFR 180.7, should be followed, 
and each petition must be accompanied by the appropriate fee, as 
specified in 40 CFR 180.33.
    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 no-observed-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 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 fed diets 
containing 0, 100, 250, or 700 ppm with a reproductive no-observed-
effect level 

[[Page 64008]]
(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 was negative for mutagenic effects in all but two 
of 23 mutagenic 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 
cucurbit vegetables. A cancer risk assessment is not appropriate for 
imidacloprid since the pesticide is assigned to ``Group E'' (no 
evidence of carcinogenicity) 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.
    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 utilizes less than 15 
percent of the RfD for the general population and less than 30 percent 
of the RfD for nonnursing infants less than 1 year in age. The proposed 
tolerance for cucurbit vegetables would utilize less than 1 percent of 
the RfD for the general population and all population subgroups.
    There is no reasonable expectation that secondary residues will 
occur in milk and eggs, or meat, fat, and meat byproducts of livestock 
or poultry; there are no livestock feed items associated with the 
cucurbit vegetables.
    The metabolism of imidacloprid in plants and livestock is 
adequately understood. The residues of concern are combined residues of 
imidacloprid and its metabolites containing the 6-chloropyridinyl 
moiety, all calculated as imidacloprid. The analytical method is a 
common moiety method for imidacloprid and its metabolites containing 
the 6-chloropyridiyl moiety using a permanganate oxidation, silyl 
derivatization, and capillary GC-MS selective ion monitoring.
    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 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 5E4598/P638] (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 4:30 p.m., Monday through Friday, excluding legal 
holidays. The public record is located in Room 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 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: November 30, 1995.

Stephen L. Johnson,
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.


[[Page 64009]]

    2. In Sec. 180.472, by adding new paragraph (f), to read as 
follows:


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

 *        *        *        *        *
    (f) Time-limited indirect or inadvertent tolerance: A time-limited 
tolerance, to expire on December 31, 1996, is established for indirect 
or inadvertent combined residues of the insecticide 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, when present therein 
as a result of the application of the pesticide to growing crops listed 
in this section and other nonfood crops as follows:

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                                                              Parts per 
                         Commmodity                            million  
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Vegetables, cucurbit.......................................          0.2
                                                                        
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[FR Doc. 95-30372 Filed 12-12-95; 8:45 am]
BILLING CODE 6560-50-F