96-15478. Chlorothalonil; Pesticide Tolerance for Use in or on Asparagus  

  • [Federal Register Volume 61, Number 119 (Wednesday, June 19, 1996)]
    [Proposed Rules]
    [Pages 31073-31075]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-15478]
    
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    40 CFR Part 180
    
    [PP 2E4042/P661; FRL-5374-6]
    RIN 2070-AC18
    
    
    Chlorothalonil; Pesticide Tolerance for Use in or on Asparagus
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Proposed rule.
    
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    SUMMARY: EPA proposes to establish a tolerance for combined residues of 
    the fungicide chlorothalonil and its metabolite in or on the raw 
    agricultural commodity asparagus. The proposed regulation to establish 
    a maximum permissible level for residues of the fungicide was requested 
    in a petition submitted by the Interregional Research Project No. 4 
    (IR-4).
    
    DATES: Comments, identified by the docket number [PP 2E4042/P661], must 
    be received on or before July 19, 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 Highway, Arlington, VA 22202.
        Comments and data may also be submitted to OPP by sending 
    electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Electronic 
    comments must be submitted as an
    
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    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 2E4042/
    P661]. 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.
        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). 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: jamerson.hoyt@epamail.epa.gov.
    
    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) 2E4042 to EPA on behalf of the Agricultural Experiment 
    Stations of Kentucky, North Carolina, Oklahoma, Virginia, 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 180.275 by establishing a tolerance for combined 
    residues of the fungicide chlorothalonil [tetrachloroisophthalonitrile] 
    and its metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile, in or 
    on the raw agricultural commodity asparagus at 0.1 part per million 
    (ppm).
        The scientific data submitted in the petition and other relevant 
    material have been evaluated. A discussion of the toxicological data 
    considered in support of the proposed tolerance for asparagus can be 
    found in a proposed rule (PP 0E3889, 2E4113, and 5E4538/P639) published 
    in the Federal Register of January 24, 1996 (61 FR 1884). The Federal 
    Register notice of January 24, 1996, also provides a discussion of the 
    basis for the EPA's classification of chlorothalonil and 
    hexachlorobenzene (HCB), a manufacturing impurity found in 
    chlorothalonil formulations, as probable human carcinogens (Group B2 of 
    EPA's classification system for carcinogens).
        Dietary risk assessments were conducted using Reference Doses 
    (RfD), the applicable cancer potency factors to assess chronic exposure 
    and risk from chlorothalonil and HCB residues, and the Margin of 
    Exposure (MOE) to assess acute toxicity from chlorothalonil residues.
        The Reference Dose (RfD) for chlorothalonil is established at 0.018 
    mg/kg of body weight (bwt)/day, based on a no-observed-effect-level 
    (NOEL) of 1.8 mg/kg/day from the 2-year feeding study in dogs, which 
    demonstrated as effects increased urinary bilirubin levels and kidney 
    vacuolated epithelium, and an uncertainty factor of 100. Available 
    information on anticipated residues and/or percent of crop treated was 
    incorporated into the analysis to estimate the Anticipated Residue 
    Contribution (ARC) from existing uses. The proposed tolerance level of 
    0.1 ppm and 100 percent crop treated were assumed to estimate dietary 
    exposure to residues of chlorothalonil from the proposed use on 
    asparagus. The ARC from existing uses and the proposed uses utilizes 
    less than 1 percent of the RfD for chlorothalonil for the U.S. 
    population and all population subgroups. EPA generally has no cause for 
    concern for exposures below 100 percent of the RfD.
        The RfD for HCB is established at 0.0008 mg/kg bwt/day based on a 
    NOEL of 0.08 mg/kg of bwt/day and an uncertainty factor of 100. The 
    NOEL was taken from a 130 week feeding study in rats that showed 
    hepatic centrilobular basophilic chromogenesis. Since there are no 
    published tolerances for HCB, the ARC was generally calculated by 
    multiplying the anticipated residues for chlorothalonil by 0.05 
    percent, an adjustment based on comparisons of residue data for the two 
    compounds from controlled field trials. The ARC for HCB from existing 
    uses of chlorothalonil and the proposed use on asparagus utilizes less 
    than 1 percent of the RfD for the U.S. population and all population 
    subgroups.
        The upper bound carcinogenic risks were calculated using the ARC 
    estimates for dietary exposure from existing uses and the proposed use 
    on asparagus, and Q*s (Q stars) of 0.00766 (mg/kg/day)-1 for 
    chlorothalonil and 1.02 (mg/kg/day)-1 for HCB. The upper bound 
    carcinogenic risk from existing and all pending uses of chlorothalonil 
    is estimated at 6.5   x  10-7, with the proposed use for asparagus 
    contributing 1.05   x  10-8 to the cancer risk assessment. The 
    upper bound carcinogenic risk for HCB is estimated at 3.2  x  10-7 
    from existing and all pending uses, with the proposed use for asparagus 
    contributing 1.2   x  10-7 to the cancer risk assessment. The 
    proposed use on asparagus would contribute negligible increases in the 
    total cancer risks from dietary exposure to residues of chlorothalonil 
    and HCB.
        The Margin of Exposure (MOE) is a measure of how closely the high-
    end acute dietary exposure comes to the NOEL from the toxicity endpoint 
    of concern. For chlorothalonil, the MOE was calculated as ratio of the 
    lowest-observed effect level (LOEL) of 175 mg/kg/day from the 
    subchronic study in rats. A NOEL was not established since an effect 
    (renal and gastric lesions) was observed at the single dose tested. An 
    uncertainty factor of 300 was used to calculate the MOE since there was 
    no available NOEL from the study. The acute dietary MOE for 
    chlorothalonil is calculated to be greater than 1,500 for the general 
    population and all population subgroups. Chlorothalonil poses minimal 
    acute dietary risk.
        The nature of the residue in asparagus is adequately understood. 
    The parent compound and its metabolite (4-hydroxy- 2,5,6-
    trichloroisophthalonitrile) are the regulated residues. An adequate 
    analytical method, is available for enforcement purposes. The method is 
    listed in the Pesticide Analytical Manual, Volume II (PAM II).
        There is no reasonable expectation that secondary residues will 
    occur in milk, eggs, or meat, fat, or meat byproducts of livestock or 
    poultry as a result of this action; there are no livestock feed items 
    associated with asparagus.
        There are presently no actions pending against the continued 
    registration of this chemical. The pesticide is considered useful for 
    the purpose for which the tolerance is sought.
        Based on the information and data considered, the Agency has 
    determined that the tolerance established by amending 40 CFR part 180 
    would
    
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    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.
        Interested persons are invited to submit written comments on the 
    proposed regulation. Comments must bear a notation indicating the 
    docket number [PP 2E4042/P661].
        A record has been established for this rulemaking under docket 
    number [PP 2E4042/P661] (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.
        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 Virginia 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 t his 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.
        This action does not impose any enforceable duty, or contain any 
    ``unfunded mandates'' as described in Title II of the Unfunded Mandates 
    Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as 
    specified by Executive Order 12875 (58 FR 58093, October 28, 1993), 
    entitled Enhancing the Intergovernmental Partnership, or special 
    consideration as required by Executive Order 12898 (59 FR 7629, 
    February 16, 1994).
        Pursuant to the requirements of the Regulatory Flexibility Act (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 explaing the factual basis for this 
    determination 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 4, 1996.
    
    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.
        2. In Sec. 180.275, the table in paragraph (a) is amended by adding 
    alphabetically the raw agricultural commodity asparagus, to read as 
    follows:
    
    
    Sec. 180.275  Chlorothalonil; tolerances for residues.
    
        (a) * * *
    
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                                                                  Parts per 
                             Commodity                             million  
    ------------------------------------------------------------------------
                                                                            
                      *        *        *        *        *                 
    Asparagus..................................................         0.10
                                                                            
                      *        *        *        *        *                 
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    * * * * *
    
    [FR Doc. 96-15478 Filed 6-18-96; 8:45 am]
    BILLING CODE 6560-50-F
    
    

Document Information

Published:
06/19/1996
Department:
Environmental Protection Agency
Entry Type:
Proposed Rule
Action:
Proposed rule.
Document Number:
96-15478
Dates:
Comments, identified by the docket number [PP 2E4042/P661], must be received on or before July 19, 1996.
Pages:
31073-31075 (3 pages)
Docket Numbers:
PP 2E4042/P661, FRL-5374-6
RINs:
2070-AC18
PDF File:
96-15478.pdf
CFR: (1)
40 CFR 180.275