98-6385. Clomazone; Extension of Tolerance for Emergency Exemptions  

  • [Federal Register Volume 63, Number 52 (Wednesday, March 18, 1998)]
    [Rules and Regulations]
    [Pages 13129-13130]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-6385]
    
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    
    40 CFR Part 180
    
    [OPP-300616; FRL-5770-9]
    RIN 2070-AB78
    
    
    Clomazone; Extension of Tolerance for Emergency Exemptions
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Final rule.
    
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    SUMMARY: This rule extends a time-limited tolerance for residues of the 
    herbicide clomazone in or on watermelons at 0.1 part per million (ppm) 
    for an additional 1-year period, to May 30, 1999. This action is in 
    response to EPA's granting of an emergency exemption under section 18 
    of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
    authorizing use of the pesticide on watermelons. Section 408(l)(6) of 
    the Federal Food, Drug, and Cosmetic Act (FFDCA) requires EPA to 
    establish a time-limited tolerance or exemption from the requirement 
    for a tolerance for pesticide chemical residues in food that will 
    result from the use of a pesticide under an emergency exemption granted 
    by EPA under section 18 of FIFRA.
    
    DATES: This regulation becomes effective March 18, 1998. Objections and 
    requests for hearings must be received by EPA, on or before May 18, 
    1998.
    ADDRESSES: Written objections and hearing requests, identified by the 
    docket control number, [OPP-300616], must be submitted to: Hearing 
    Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
    SW., Washington, DC 20460. Fees accompanying objections and hearing 
    requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: 
    EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), 
    P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and 
    hearing requests filed with the Hearing Clerk identified by the docket 
    control number, [OPP-300616], must also be submitted to: Public 
    Information and Records Integrity Branch, Information Resources and 
    Services Division (7502C), Office of Pesticide Programs, Environmental 
    Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
    bring a copy of objections and hearing requests to Rm. 119, Crystal 
    Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
        A copy of objections and hearing requests filed with the Hearing 
    Clerk may also be submitted electronically by sending electronic mail 
    (e-mail) to: opp-docket@epamail.ep. Follow the instructions in 
    Unit II. of this preamble. No Confidential Business Information (CBI) 
    should be submitted through e-mail.
    
    FOR FURTHER INFORMATION CONTACT: By mail: Virginia Dietrich, 
    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. 272, CM #2, 
    1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-308-9359; e-mail: 
    dietrich.virginia@epamail.epa.gov.
    
    SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the 
    Federal Register of May 2, 1997 (62 FR 24040-24045) (FRL-5713-6), which 
    announced that on its own initiative and under section 408(e) of the 
    FFDCA, 21 U.S.C. 346a(e) and (l)(6), it established a time-limited 
    tolerance for the residues of clomazone and its metabolites in or on 
    watermelons at 2 ppm, with an expiration date of May 30, 1998. EPA 
    established the tolerance because section 408(l)(6) of the FFDCA 
    requires EPA to establish a time-limited tolerance or exemption from 
    the requirement for a tolerance for pesticide chemical residues in food 
    that will result from the use of a pesticide under an emergency 
    exemption granted by EPA under section 18 of FIFRA. Such tolerances can 
    be established without providing notice or period for public comment.
        EPA received a request to extend the use of clomazone on 
    watermelons for this year growing season because no herbicides with 
    efficacy similar to clomazone are currently registered for use and that 
    without clomazone, significant economic loss will likely result. After 
    having reviewed the submission, EPA concurs that emergency conditions 
    exist for this state. EPA has authorized under FIFRA section 18 the use 
    of clomazone on watermelons for control of weeds in watermelons.
        EPA assessed the potential risks presented by residues of clomazone 
    in or on watermelons. In doing so, EPA considered the new safety 
    standard in FFDCA section 408(b)(2), and decided that the necessary 
    tolerance under FFDCA section 408(l)(6) would be consistent with the 
    new safety standard and with FIFRA section 18. The data and other 
    relevant material have been evaluated and discussed in the final rule 
    of May 2, 1997 (62 FR 24040-24045). Based on that data and information 
    considered, the Agency reaffirms that extension of the time-limited 
    tolerance will continue to meet the requirements of section 408(l)(6). 
    Therefore, the time-limited tolerance is extended for an additional 1-
    year period. Although this tolerance will expire and is revoked on May 
    30, 1998, under FFDCA section 408(l)(5), residues of the pesticide not 
    in excess of the amounts specified in the tolerance remaining in or on 
    watermelons after that date will not be unlawful, provided the 
    pesticide is applied in a manner that was lawful under FIFRA and the 
    application occurred prior to the revocation of the tolerance. EPA will 
    take action to revoke this tolerance earlier if any experience with, 
    scientific data on, or other relevant information on this pesticide 
    indicate that the residues are not safe.
    
    I. Objections and Hearing Requests
    
         The new FFDCA section 408(g) provides essentially the same process 
    for persons to ``object'' to a tolerance regulation issued by EPA under 
    new section 408(e) and (l)(6) as was provided in the old section 408 
    and in section 409. However, the period for filing objections is 60 
    days, rather than 30 days. EPA currently has procedural regulations 
    which govern the submission of objections and hearing requests. These 
    regulations will require some modification to reflect the new law. 
    However, until those modifications can be made, EPA will continue to 
    use those procedural regulations with appropriate adjustments to 
    reflect the new law.
        Any person may, by May 18, 1998, file written objections to any 
    aspect of this 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 issues on which a hearing is requested, the 
    requestor's contentions on such issues, and a summary of any evidence 
    relied upon by the requestor (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
    
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    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 issues in the manner sought by 
    the requestor would be adequate to justify the action requested (40 CFR 
    178.32). Information submitted in connection with an objection or 
    hearing request may be claimed confidential by marking any part or all 
    of that information as CBI. Information so marked will not be disclosed 
    except in accordance with procedures set forth in 40 CFR part 2. A copy 
    of the information 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.
    
    II. Public Record and Electronic Submissions
    
        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 
    Virginia address in ``ADDRESSES''at the beginning of this document.
        Electronic comments may be sent directly to EPA at:
        opp-docket@epamail.epa.gov.
    
    
        Electronic objections and hearing requests must be submitted as an 
    ASCII file avoiding the use of special characters and any form of 
    encryption. Objections and hearing requests will also be accepted on 
    disks in WordPerfect 51/6.1 or ASCII file format. All copies of 
    objections and hearing requests in electronic form must be identified 
    by the docket control number [OPP-300616]. No CBI should be submitted 
    through e-mail. Electronic copies of objections and hearing requests on 
    this rule may be filed online at many Federal Depository Libraries.
    
    III. Regulatory Assessment Requirements
    
        This final rule extends a time-limited tolerance that was 
    previously extended by EPA under FFDCA section 408(d) in response to a 
    petition submitted to the Agency. The Office of Management and Budget 
    (OMB) has exempted these types of actions from review under Executive 
    Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 
    October 4, 1993). In addition, this final rule does not contain any 
    information collections subject to OMB approval under the Paperwork 
    Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
    duty or contain any unfunded mandate as described under Title II of the 
    Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does 
    it require any prior consultation as specified by Executive Order 
    12875, entitled Enhancing the Intergovernmental Partnership (58 FR 
    58093, October 28, 1993), or special considerations as required by 
    Executive Order 12898, entitled Federal Actions to Address 
    Environmental Justice in Minority Populations and Low-Income 
    Populations (59 FR 7629, February 16, 1994), or require OMB review in 
    accordance with Executive Order 13045, entitled Protection of Children 
    from Environmental Health Risks and Safety Risks (62 FR 19885, April 
    23, 1997).
        Since this extension of an existing time-limited tolerance does not 
    require the issuance of a proposed rule, the requirements of the 
    Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. 
    Nevertheless, the Agency has previously assessed whether establishing 
    tolerances, exemptions from tolerances, raising tolerance levels or 
    expanding exemptions might adversely impact small entities and 
    concluded, as a generic matter, that there is no adverse economic 
    impact. The factual basis for the Agency's generic certification for 
    tolerance actions published on May 4, 1981 (46 FR 24950), and was 
    provided to the Chief Counsel for Advocacy of the Small Business 
    Administration.
    
    IV. Submission to Congress and the Comptroller General
    
        The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
    Small Business Regulatory Enforcement Fairness Act of 1996, generally 
    provides that before a rule may take effect, the agency promulgating 
    the rule must submit a rule report, which includes a copy of the rule, 
    to each House of the Congress and to the Comptroller General of the 
    United States. EPA will submit a report containing this rule and other 
    required information to the U.S. Senate, the U.S. House of 
    Representatives, and the Comptroller General of the United States prior 
    to publication of the rule in the Federal Register. This rule is not a 
    ``major rule'' as defined by 5 U.S.C. 804(2).
    
    List of Subjects in 40 CFR Part 180
    
        Environmental protection, Administrative practice and procedure, 
    Agricultural commodities, Pesticides and pests, Reporting and 
    recordkeeping requirements.
    
        Dated: March 3, 1998.
    
    James Jones,
    
    Director, Registration Division, Office of Pesticide Programs.
        Therefore, 40 CFR chapter I 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.
    
    Sec. 180.425   [Amended]
    
        2. In Sec. 180.425, by amending paragraph (b) in the table, for the 
    commodity ``watermelons'' by removing the date ``May 30, 1998'' and by 
    adding in its place ``5/30/99.''
    
    [FR Doc. 98-6385 Filed 3-17-98; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Effective Date:
3/18/1998
Published:
03/18/1998
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
98-6385
Dates:
This regulation becomes effective March 18, 1998. Objections and requests for hearings must be received by EPA, on or before May 18, 1998.
Pages:
13129-13130 (2 pages)
Docket Numbers:
OPP-300616, FRL-5770-9
RINs:
2070-AB78
PDF File:
98-6385.pdf
CFR: (1)
40 CFR 180.425