[Federal Register Volume 61, Number 31 (Wednesday, February 14, 1996)]
[Rules and Regulations]
[Pages 5714-5716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-3280]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP PP 5F4534/R2199; FRL-4995-2]
RIN 2070-AC18


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) (proposed common name ``imidacloprid'') and its 
metabolites in or on canola seed. Gustafson, Inc. requested this 
regulation to establish maximum permissible levels for residues of the 
insecticide.

EFFECTIVE DATE: This regulation became effective February 7, 1996.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [PP 5F4534/R2199], 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. 
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 
the Hearing Clerk may be submitted to OPP by sending electronic mail 
(e-mail) to:
    [email protected]
    Copies of electronic objections and hearing requests must be 
submitted as an ASCII file avoiding the use of special characters and 
any form of encryption. Copies of electronic objections and hearing 
requests will also be accepted on disks in WordPerfect 5.1 file format 
or ASCII file format. All copies of electronic objections and hearing 
requests must be identified by the docket number [PP 5F4534/R2199]. No 
Confidential Business Information (CBI) should be submitted through e-
mail. Copies of electronic objections and hearing requests on this rule 
may be filed online at many Federal Depository Libraries. Additional 
information on electronic submissions can be found below in this 
document.

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 published in the Federal 
Register of August 17, 1995 (60 FR 42884), which announced that 
Gustafson, Inc., P.O. Box 660065, Dallas, TX 75266-0065, had submitted 
to amend 40 CFR part 180 by establishing a regulation to permit 
residues of the insecticide (1-[6-chloro-3-pyridinyl) methyl]-N-nitro-
2-imidazolidinime, in or on the raw agricultural commodity canola seed 
at 0.05 parts per million (ppm).

[[Page 5715]]

    The Agency is currently issuing a 2-year conditional registration 
for use of ``imidacloprid'' on canola seed. Additional residue trials 
are needed. On June 2, 1994, the Agency issued a guidance document on 
crop residue trials. Among other things, this document provided 
guidance on the number and location of domestice crop field trials for 
establishment of pesticide residue trials. Based on this guidance 
document, the Agency determined that additional field trials are needed 
for canola. However, the Agency does not believe that this data will 
significantly change its risk assessment.
    The scientific data submitted in the petition and other relevant 
material have been evaluated. The toxicological data considered in 
support of the tolerance include:
    1. A three-generation rat reproduction study with 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, 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 decrease 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 carcinoginicity 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) for published uses is 
0.008189 mg/kg/bwt/day utilizing 14.4% of the RFD. The proposed 
tolerance will increase the TMRC by .000077 mg/kg/day representing an 
increase in the ADI of 1.5%. The TMRC will be .008266 mg/kg/day 
utilizing 15.9% of the RFD. For exposure of subgroups in the 
population, children (1-6), the TMRC for the published and proposed 
tolerances is 0.016934 mg/kg/day. This is equal to 29.7% 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 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-chloropyridinyl 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. Canola meal is a livestock feedstuff ruminant, and poultry 
feeding studies show transfer of imidacloprid from feedstuff to meat, 
milk, poultry, and eggs. The secondary tolerances in meat, milk, 
poutry, eggs are adequate to cover the additional use on canola.
    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 tolerance established by amending 40 CFR 
part 180 will protect the public health. Therefore, the tolerance is 
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).
    A record has been established for this rulemaking under docket 
number [PP 5F4535/R2199] (including any comments and data submitted 
electronically). 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 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.
    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 any copies of objections and hearing requests 
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, 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 

[[Page 5716]]
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. 9-354, 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: February 7, 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. In Sec. 180.472, by amending paragraph (a) in the table therein 
by adding and alphabetically inserting 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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                  Commodities                       Parts per million   
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              *        *        *        *        *                     
Canola.........................................                     0.05
                                                                        
              *        *        *        *        *                     
------------------------------------------------------------------------

Residues in these commodities not in excess of the established 
tolerances resulting from the use described in this paragraph remaining 
after expiration of the conditional registration will not be considered 
to be actionable if the insecticide is applied during the term of and 
in accordance with the provisions of the above regulation.
    *    *    *    *    *
[FR Doc. 96-3280 Filed 2-13-96; 8:45 am]
BILLING CODE 6560-50-F