99-11385. Myclobutanil; Extension of Tolerance for Emergency Exemptions  

  • [Federal Register Volume 64, Number 87 (Thursday, May 6, 1999)]
    [Rules and Regulations]
    [Pages 24292-24295]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 99-11385]
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    
    40 CFR Part 180
    
    [OPP-300846; FRL-6074-9]
    RIN 2070-AB78
    
    
    Myclobutanil; Extension of Tolerance for Emergency Exemptions
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Final rule.
    
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    SUMMARY: This regulation extends a time-limited tolerance for combined 
    residues of the fungicide myclobutanil and its metabolite in or on 
    strawberries at 0.5 parts per million (ppm) for an additional 1-year 
    period. This tolerance will expire and is revoked on March 31, 2000. 
    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 strawberries. Section 
    408(l)(6) of the Federal Food, Drug, and Cosmetic Act 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 FIFRA section 18.
    
    DATES: This regulation becomes effective May 6, 1999. Objections and 
    requests for hearings must be received by EPA, on or before July 6, 
    1999.
    
    ADDRESSES: Written objections and hearing requests, identified by the 
    docket control number [OPP-300846], must be submitted to: Hearing Clerk
    
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    (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-300846], 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@epa.gov. 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 objections and 
    hearing requests will also be accepted on disks in WordPerfect 5.1/6.1 
    or ASCII file format. All copies of electronic objections and hearing 
    requests must be identified by the docket control number [OPP-300846]. 
    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.
    
    FOR FURTHER INFORMATION CONTACT: By mail: Stephen Schaible, 
    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., 271, 
    Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, 703-308-
    9362; e-mail: schaible.stephen@epa.gov.
    
    SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the 
    Federal Register of April, 11, 1997 (62 FR 17730) (FRL-5597-9), which 
    announced that on its own initiative under section 408 of the Federal 
    Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a and (l)(6), as 
    amended by the Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-
    170) it established a time-limited tolerance for the combined residues 
    of myclobutanil and its metabolite in or on strawberries at 0.5 ppm, 
    with an expiration date of March 31, 1998. EPA extended the expiration 
    date of this tolerance to March 31, 1999, in a Federal Register notice 
    published March 4, 1998 (FRL 5772-8). 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 FIFRA section 18. Such tolerances can be established without 
    providing notice or period for public comment.
        EPA received a request to extend the use of myclobutanil on 
    strawberries for this year growing season due to continued incidence of 
    powdery mildew in Florida and California and the claimed 
    ineffectiveness of registered alternatives at controlling the disease. 
    After having reviewed the submission, EPA concurs that an emergency 
    condition could exist. EPA has authorized under FIFRA section 18 the 
    use of myclobutanil on strawberries for control of powdery mildew in 
    strawberries.
        EPA assessed the potential risks presented by residues of 
    myclobutanil in or on strawberries. In doing so, EPA considered the 
    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 safety standard and with FIFRA section 18. The data and other 
    relevant material have been evaluated and discussed in the final rule 
    of April 11, 1997 (62 FR 17730) (FRL-5597-9). 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. EPA will publish a document in the 
    Federal Register to remove the revoked tolerance from the Code of 
    Federal Regulations (CFR). Although this tolerance will expire and is 
    revoked on March 31, 2000, under FFDCA section 408(l)(5), residues of 
    the pesticide not in excess of the amounts specified in the tolerance 
    remaining in or on strawberries 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 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 July 6, 1999, 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 under the ``ADDRESSES'' section (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). EPA is authorized to waive any fee requirement 
    ``when in the judgement of the Administrator such a waiver or refund is 
    equitable and not contrary to the purpose of this subsection.'' For 
    additional information regarding tolerance objection fee waivers, 
    contact James Tompkins, 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. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
    Arlington, VA, (703) 305-5697, tompkins.jim@epa.gov. Requests for 
    waiver of tolerance objection fees should be sent to James Hollins, 
    Information Resources and Services Division (7502C), Office of 
    Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
    Washington, DC 20460.
        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
    
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    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 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
    
        EPA has established a record for this regulation under docket 
    control number [OPP-300846] (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 8:30 a.m. 
    to 4 p.m., Monday through Friday, excluding legal holidays. The public 
    record is located in Room 119 of the Public Information and Records 
    Integrity Branch, Information Resources and Services Division (7502C), 
    Office of Pesticide Programs, Environmental Protection Agency, Crystal 
    Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
        Objections and hearing requests may be sent by e-mail directly to 
    EPA at:
        opp-docket@epa.gov.
    
    
        E-mailed objections and hearing requests must be submitted as an 
    ASCII file avoiding the use of special characters and any form of 
    encryption.
        The official record for this regulation, as well as the public 
    version, as described in this unit 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 record which 
    will also include all comments submitted directly in writing. The 
    official record is the paper record maintained at the Virginia address 
    in ``ADDRESSES'' at the beginning of this document.
    
    III. Regulatory Assessment Requirements
    
    A. Certain Acts and Executive Orders
    
        This final rule establishes a tolerance under section 408 of the 
    FFDCA. 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). 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).
        In addition, since tolerances and exemptions that are established 
    under section 408(l)(6) of FFDCA, such as the exemption in this final 
    rule, do 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 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.
    
    B. Executive Order 12875
    
        Under Executive Order 12875, entitled Enhancing the 
    Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
    not issue a regulation that is not required by statute and that creates 
    a mandate upon a State, local or tribal government, unless the Federal 
    government provides the funds necessary to pay the direct compliance 
    costs incurred by those governments. If the mandate is unfunded, EPA 
    must provide to OMB a description of the extent of EPA's prior 
    consultation with representatives of affected State, local, and tribal 
    governments, the nature of their concerns, copies of any written 
    communications from the governments, and a statement supporting the 
    need to issue the regulation. In addition, Executive Order 12875 
    requires EPA to develop an effective process permitting elected 
    officials and other representatives of State, local, and tribal 
    governments ``to provide meaningful and timely input in the development 
    of regulatory proposals containing significant unfunded mandates.''
        Today's rule does not create an unfunded Federal mandate on State, 
    local, or tribal governments. The rule does not impose any enforceable 
    duties on these entities. Accordingly, the requirements of section 1(a) 
    of Executive Order 12875 do not apply to this rule.
    
    C. Executive Order 13084
    
        Under Executive Order 13084, entitled Consultation and Coordination 
    with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not 
    issue a regulation that is not required by statute, that significantly 
    or uniquely affects the communities of Indian tribal governments, and 
    that imposes substantial direct compliance costs on those communities, 
    unless the Federal government provides the funds necessary to pay the 
    direct compliance costs incurred by the tribal governments. If the 
    mandate is unfunded, EPA must provide OMB, in a separately identified 
    section of the preamble to the rule, a description of the extent of 
    EPA's prior consultation with representatives of affected tribal 
    governments, a summary of the nature of their concerns, and a statement 
    supporting the need to issue the regulation. In addition, Executive 
    Order 13084 requires EPA to develop an effective process permitting 
    elected officials and other representatives of Indian tribal 
    governments ``to provide meaningful and timely input in the development 
    of regulatory policies on matters that significantly or uniquely affect 
    their communities.''
        Today's rule does not significantly or uniquely affect the 
    communities of Indian tribal governments. This action does not involve 
    or impose any requirements that affect Indian tribes. Accordingly, the 
    requirements of section 3(b) of Executive Order 13084 do not apply to 
    this rule.
    
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    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 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: April 23, 1999.
    
    Peter Caulkins,
    Acting 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. 321(q), 346(a), and 371.
    
    
    Sec. 180.443   [Amended]
    
        2. In Sec. 180.443, by amending the table in paragraph (b), by 
    revising the date for Strawberries from ``3/31/99'' to read ``3/31/
    00''.
    
    [FR Doc. 99-11385 Filed 5-5-99; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Effective Date:
5/6/1999
Published:
05/06/1999
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
99-11385
Dates:
This regulation becomes effective May 6, 1999. Objections and requests for hearings must be received by EPA, on or before July 6, 1999.
Pages:
24292-24295 (4 pages)
Docket Numbers:
OPP-300846, FRL-6074-9
RINs:
2070-AB78
PDF File:
99-11385.pdf
CFR: (1)
40 CFR 180.443