95-5653. Pesticide Tolerance for Imidacloprid  

  • [Federal Register Volume 60, Number 45 (Wednesday, March 8, 1995)]
    [Rules and Regulations]
    [Pages 12704-12705]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 95-5653]
    
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    40 CFR Part 180
    
    [PP 4F4285/R2110/FRL-4935-5]
    RIN 2070-AB78
    
    
    Pesticide Tolerance for Imidacloprid
    
    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 (common name ``imidacloprid''), 
    in or on the raw agricultural commodity mango at 0.2 part per million 
    (ppm). Miles, Inc., requested this regulation to establish a maximum 
    permissible level for residues of the insecticide.
    
    EFFECTIVE DATE: This regulation becomes effective March 8, 1995.
    
    ADDRESSES: Written objections and hearing requests, identified by the 
    document control number, [PP 4F4285/R2110], may be submitted to: 
    Hearing Clerk (1900), 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 
    document 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.
    
    FOR FURTHER INFORMATION CONTACT: By mail: Dennis H. Edwards, Product 
    Manager (PM 19), Registration Division (7505C), Office of Pesticide 
    Programs, 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)-305-3686.
    
    SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the 
    Federal Register of July 13, 1994 (59 FR 35718), which announced that 
    Miles, Inc., 8400 Hawthorn Rd., P.O. Box 4913, Kansas City, MO 64120-
    0013, had submitted pesticide petition 4F4285 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 (imidacloprid) in or on the raw agricultural 
    mango at 0.2 ppm.
        There were no comments or requests for referral to an advisory 
    committee received in response to this notice of filing.
        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 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 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 [[Page 12705]] 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 
    uncertainty factor, is calculated to be 0.057 mg/kg/bwt. The 
    theoretical maximum residue contribution (TMRC) from published uses is 
    0.000985 mg/kg/bwt/day. This represents 2% of the RfD. The proposed 
    tolerance contributes 0.000001 mg/kg/bwt/day. This represents no 
    significant increase in 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-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 on mangoes at 
    0.2 ppm when use as directed.
        There are currently 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, 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 a 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.
    
        Dated: February 21, 1995.
    
    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 entry for mango, 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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                                                                   Part per 
                             Commodity                             million  
    ------------------------------------------------------------------------
                                                                            
                      *        *        *        *        *                 
    Mango......................................................          0.2
                                                                            
                      *        *        *        *        *                 
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    *        *        *        *        *
    
    [FR Doc. 95-5653 Filed 3-7-95; 8:45 am]
    BILLING CODE 6560-50-F
    
    

Document Information

Effective Date:
3/8/1995
Published:
03/08/1995
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
95-5653
Dates:
This regulation becomes effective March 8, 1995.
Pages:
12704-12705 (2 pages)
Docket Numbers:
PP 4F4285/R2110/FRL-4935-5
RINs:
2070-AB78
PDF File:
95-5653.pdf
CFR: (1)
40 CFR 180.472