[Federal Register Volume 61, Number 87 (Friday, May 3, 1996)]
[Rules and Regulations]
[Pages 19855-19857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10915]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 5F4600/5H5733/R2233; FRL-5364-5]
RIN 2070-AB18


Imidacloprid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule establishes a tolerance for residues of the 
insecticide (1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine) and its metabolites in or on pome fruits. Bayer 
Corporation (formerly Miles, Inc.) requested this regulation to 
establish these maximum permissible levels for residues of the 
insecticide.

EFFECTIVE DATES: This regulation became effective April 19, 1996.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [PP 5F4600/5H5733/R2233], may be submitted to: 
Hearing Clerk (A-110), Environmental Protection Agency, Rm. M3708, 401 
M St., SW., Washington, DC 20460. A copy of any objections and hearing 
requests filed with the Hearing Clerk should be identified by the 
docket control number and submitted 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 copy of objections and hearing 
requests to Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 
22202. Fees accompanying objections shall be labeled ``Tolerance 
Petition Fees'' and forwarded to: EPA Headquarters Accounting 
Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, 
PA 15251. An electronic copy of objections and hearing requests filed 
with Hearing Clerk may be submitted to OPP by sending electronic mail 
(e-mail) to: [email protected].

FOR FURTHER INFORMATION CONTACT: By mail: Dennis H. Edwards, Jr., 
Product Manager (PM) 19, Registration Division (7505C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: Rm. 207, CM #2, 1921 Jefferson Davis Highway, Arlington, VA, 
(703) 305-6386; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: EPA issued a notice in the Federal Register 
of November 15, 1995 (60 FR 57423), which announced that Bayer 
Corporation, 8400 Hawthorn Road, P.O. Box 4913, Kansas City, MO 64120-
0013, had submitted pesticide petition 5F4600/5H5733 to EPA requesting 
that the Administrator, pursuant to section 408(d) of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), establish tolerances 
for residues of the insecticide 1-[(6-chloro-3-pyridinyl)methyl]-N-
nitro-2-imidazolidinimine in or on pome fruit (fresh fruit) including 
apple, pear, crabapple, loquat, mayhaw, pear

[[Page 19856]]

(oriental) and quince, at 0.6 ppm and a Food Additive Tolerance (FAT) 
5H5733 in or on apples, pomace (wet or dried) at 4.0 ppm. There were no 
comments or request for referral to an advisory committee received in 
response to this notice of filing. Subsequent to the notice of filing 
Bayer submitted a revised Section F deleting the 4 ppm apple pomace 
tolerance that was proposed in the pome fruit petition. The reason 
apple pomace was deleted is because dried apple pomace is no longer 
considered a significant livestock feedstuff in the Agency's September 
1995 revised Table II and there is no significant concentration from 
apples to wet apple pomace.
    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 
developmental toxicity 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 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 under ``Group E'' (no evidence of 
carcinogenicity) by EPA's OPP/HED's 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 published uses is 
0.008187 mg/kg/bwt/day utilizing 14.4% of the RfD. The tolerance will 
increase the TMRC by .000154 mg/kg/day representing an increase in the 
ADI of 0.3%. Thus the TMRC will be .008340 mg/kg/day utilizing 14.6% of 
the RfD. For exposure of the most highly exposured subgroups in the 
population, children (ages 1-6), the TMRC for the tolerances is 
0.016570 mg/kg/day. This is equal to 29.1% of the RfD. Dietary exposure 
from the existing uses and proposed use will not exceed the reference 
dose for any subpopulation (including infants and children) based on 
the information available from EPA's Dietary Risk Evaluation System.
    The nature of the imidacloprid residue in plants and livestock is 
adequately understood. The residues of concern are combined residues of 
imidacloprid and it 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. 
Imidacloprid and its metabolites are stable in the commodities when 
frozen for at least 24 months. There are adequate amounts of 
geographically representative crop field trial data to show that 
combined residues of imidacloprid and its metabolites, all calculated 
as imidacloprid, will not exceed the proposed tolerance when used as 
directed.
    There are presently no actions pending against the continued 
registration of this chemical.
    This pesticide is considered useful for the purposes for which the 
tolerance is sought and capable of achieving the intended physical or 
technical effect. Based on the information and data considered, the 
Agency has determined that the tolerances established by amending 40 
CFR part 180 will protect the public health. Therefore, these 
tolerances are established as set forth below.
    Any person adversely affected by this regulation may, within 30 
days after publication of this document in the Federal Register, file 
written objections to the regulation and may also request a hearing on 
those objections. Objections and hearing requests must be filed with 
the Hearing Clerk, at the address given above (40 CFR 178.20). A copy 
of the objections and/or hearing requests filed with the Hearing Clerk 
should be submitted to the OPP docket for this rulemaking. The 
objections submitted must specify the provisions of the regulation 
deemed objectionable and the grounds for the objections (40 CFR 
178.25). Each objection must be accompanied by the fee prescribed by 40 
CFR 180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issue(s) on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the objector (40 CFR 178.27). A request for a hearing 
will be granted if the Administrator determines that the material 
submitted shows the following: There is genuine and substantial issue 
of fact; there is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one or more 
of such issues in favor of the requestor, taking into account 
uncontested claims or facts to the contrary; and resolution of the 
factual issue(s) in the manner sought by the requestor would be 
adequate to justify the action requested (40 CFR 178.32).
    Under Executive Order 12866 (58 FR 51735, October 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.


[[Page 19857]]


    Dated: April 19, 1996.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR part 180 is 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. Section 180.472(a) is amended in the table therein by adding in 
alphabetical order the following commodity to read as follows:


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

    (a)  *    *    *

                                                                        
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                 Commodity                        Parts per million     
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                  *        *        *        *        *                 
Pome fruits crop group                      0.6                         
                                                                        
                  *        *        *        *        *                 
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[FR Doc. 96-10915 Filed 5-02-96; 8:45 am]
BILLING CODE 6560-50-F