99-30409. Avermectin B1 and its delta-8,9-isomer; Extension of Tolerance for Emergency Exemptions  

  • [Federal Register Volume 64, Number 224 (Monday, November 22, 1999)]
    [Rules and Regulations]
    [Pages 63709-63711]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 99-30409]
    
    
    
    40 CFR Part 180
    
    [OPP-300948; FRL-6391-8]
    RIN 2070-AB78
    
    
    Avermectin B1 and its delta-8,9-isomer; 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 the 
    combined residues of the insecticide and miticide avermectin 
    B1 and its delta-8,9-isomer in or on celeriac at 0.05 part 
    per million (ppm) for an additional 1-year period. This tolerance will 
    expire and is revoked on December 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 authorizing use of 
    the pesticide on celeriac. 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 section 18 of the Federal 
    Insecticide, Fungicide, and Rodenticide Act.
    
    DATES: This regulation is effective November 22, 1999. Objections and 
    requests for hearings, identified by docket control number OPP-300948, 
    must be received by EPA on or before January 21, 2000.
    
    ADDRESSES: Written objections and hearing requests may be submitted by 
    mail, in person, or by courier. Please follow the detailed instructions 
    for each method as provided in Unit III. of the ``SUPPLEMENTARY 
    INFORMATION.'' To ensure proper receipt by EPA, your objections and 
    hearing requests must identify docket control number OPP-300948 in the 
    subject line on the first page of your response.
    
    FOR FURTHER INFORMATION CONTACT: By mail: Dan Rosenblatt, Registration 
    Division (7505C), Office of Pesticide Programs, Environmental 
    Protection Agency, 401 M St., SW., Washington, DC 20460; telephone 
    number: (703) 308-9375; and e-mail address: rosenblatt.dan@epa.gov.
    SUPPLEMENTARY INFORMATION:
    
    I. General Information
    
    A. Does this Action Apply to Me?
    
        You may be affected by this action if you are an agricultural 
    producer, food manufacturer, or pesticide manufacturer. Potentially 
    affected categories and entities may include, but are not limited to:
    
     
    ------------------------------------------------------------------------
                                                              Examples of
               Categories                 NAICS codes         potentially
                                                           affected entities
    ------------------------------------------------------------------------
    Industry                          111                 Crop production
                                      112                 Animal production
                                      311                 Food manufacturing
                                      32532               Pesticide
                                                           manufacturing
    ------------------------------------------------------------------------
    
        This listing is not intended to be exhaustive, but rather provides 
    a guide for readers regarding entities likely to be affected by this 
    action. Other types of entities not listed in the table could also be 
    affected. The North American Industrial Classification System (NAICS) 
    codes have been provided to assist you and others in determining 
    whether or not this action might apply to certain entities. If you have 
    questions regarding the applicability of this action to a particular 
    entity, consult the person listed under ``FOR FURTHER INFORMATION 
    CONTACT.''
    
    B. How Can I Get Additional Information, Including Copies of this 
    Document and Other Related Documents?
    
        1. Electronically.You may obtain electronic copies of this 
    document, and certain other related documents that might be available 
    electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
    To access this document, on the Home Page select ``Laws and 
    Regulations'' and then look up the entry for this document under the 
    ``Federal Register--Environmental Documents.'' You can also go directly 
    to the Federal Register listings at http://www.epa.gov/fedrgstr/.
        2. In person. The Agency has established an official record for 
    this action under docket control number OPP-300948. The official record 
    consists of the documents specifically referenced in this action, and 
    other information related to this action, including any information 
    claimed as Confidential Business Information (CBI). This official 
    record includes the documents that are physically located in the 
    docket, as well as the documents
    
    [[Page 63710]]
    
    that are referenced in those documents. The public version of the 
    official record does not include any information claimed as CBI. The 
    public version of the official record, which includes printed, paper 
    versions of any electronic comments submitted during an applicable 
    comment period is available for inspection in the Public Information 
    and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 
    Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday 
    through Friday, excluding legal holidays. The PIRIB telephone number is 
    (703) 305-5805.
    
    II. Background and Statutory Findings
    
        EPA issued a final rule, published in the Federal Register of 
    August 19, 1997 (62 FR 44089) (FRL-5737-1), which announced that on its 
    own initiative under section 408 of the Federal Food, Drug, and 
    Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality 
    Protection Act of 1996 (FQPA) (Public Law 104-170) it established a 
    time-limited tolerance for the combined residues of avermectin 
    B1 and its delta-8,9-isomer in or on celeriac at 0.05 ppm, 
    with an expiration date of July 31, 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 the Federal Insecticide, Fungicide, and Rodenticide 
    Act (FIFRA). Such tolerances can be established without providing 
    notice or period for public comment. In the Federal Register of August 
    7, 1998 (63 FR 42246) (FRL-6021-2), EPA extended the time-limited 
    tolerance for the combined residues of avermectin B1 and its 
    delta-8,9-isomer in or on celeriac at 0.05 ppm, with an expiration date 
    of January 31, 2000.
        EPA received a request to extend the use of avermectin 
    B1 and its delta-8,9-isomer on celeriac for this year's 
    growing season due to continued pest pressure from the two-spotted 
    spider mite. After having reviewed the submission, EPA concurs that 
    emergency conditions exist. EPA has authorized under FIFRA section 18 
    the use of avermectin B1 and its delta-8,9-isomer on 
    celeriac for control of the two-spotted spider mite in celeriac.
        EPA assessed the potential risks presented by residues of 
    avermectin B1 and its delta-8,9-isomer in or on celeriac. 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 August 19, 1997 (62 FR 44089) (FRL-
    5737-1). 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 December 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 celeriac 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.
    
    III. Objections and Hearing Requests
    
        Under section 408(g) of the FFDCA, as amended by the FQPA, any 
    person may file an objection to any aspect of this regulation and may 
    also request a hearing on those objections. The EPA procedural 
    regulations which govern the submission of objections and requests for 
    hearings appear in 40 CFR part 178. Although the procedures in those 
    regulations require some modification to reflect the amendments made to 
    the FFDCA by the FQPA of 1996, EPA will continue to use those 
    procedures, with appropriate adjustments, until the necessary 
    modifications can be made. The new section 408(g) provides essentially 
    the same process for persons to ``object'' to a regulation for an 
    exemption from the requirement of a tolerance issued by EPA under new 
    section 408(d), as was provided in the old FFDCA sections 408 and 409. 
    However, the period for filing objections is now 60 days, rather than 
    30 days.
    
    A. What Do I Need to Do to File an Objection or Request a Hearing?
    
        You must file your objection or request a hearing on this 
    regulation in accordance with the instructions provided in this unit 
    and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
    identify docket control number OPP-300948 in the subject line on the 
    first page of your submission. All requests must be in writing, and 
    must be mailed or delivered to the Hearing Clerk on or before January 
    21, 2000.
        1. Filing the request. Your objection must specify the specific 
    provisions in the regulation that you object to, and the grounds for 
    the objections (40 CFR 178.25). If a hearing is requested, the 
    objections must include a statement of the factual issues(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). 
    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.
        Mail your written request to: Office of the Hearing Clerk (1900), 
    Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
    You may also deliver your request to the Office of the Hearing Clerk in 
    Rm. M3708, Waterside Mall, 401 M St., SW., Washington, DC 20460. The 
    Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday 
    through Friday, excluding legal holidays. The telephone number for the 
    Office of the Hearing Clerk is (202) 260-4865.
        2. Tolerance fee payment. If you file an objection or request a 
    hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
    request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
    mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
    of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
    identify the fee submission by labeling it ``Tolerance Petition Fees.''
        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 the waiver of these fees, you may contact James 
    Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, 
    or by mailing a request for information to Mr. Tompkins at Registration 
    Division (7505C), Office of Pesticide Programs, Environmental 
    Protection Agency, 401 M St., SW., Washington, DC 20460.
        If you would like to request a waiver of the tolerance objection 
    fees, you must mail your request for such a waiver to: James Hollins, 
    Information Resources
    
    [[Page 63711]]
    
    and Services Division (7502C), Office of Pesticide Programs, 
    Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
        3. Copies for the Docket. In addition to filing an objection or 
    hearing request with the Hearing Clerk as described in Unit III.A., you 
    should also send a copy of your request to the PIRIB for its inclusion 
    in the official record that is described in Unit I.B.2. Mail your 
    copies, identified by docket control number OPP-300948, 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 or 
    by courier, bring a copy to the location of the PIRIB described in Unit 
    I.B.2. You may also send an electronic copy of your request via e-mail 
    to: opp-docket@epa.gov. Please use an ASCII file format and avoid 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 6.1/8.0 file format or ASCII file format. Do not 
    include any CBI in your electronic copy. You may also submit an 
    electronic copy of your request at many Federal Depository Libraries.
    
    B. When Will the Agency Grant a Request for a Hearing?
    
        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 issues(s) in the manner sought 
    by the requestor would be adequate to justify the action requested (40 
    CFR 178.32).
    
    IV. Regulatory Assessment Requirements
    
        This final rule establishes a time-limited tolerance under FFDCA 
    section 408. 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) (Public Law 104-4). Nor does it require any prior consultation 
    as specified by Executive Order 13084, entitled Consultation and 
    Coordination with Indian Tribal Governments (63 FR 27655, May 19, 
    1998); 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 or any Agency action under Executive Order 13045, 
    entitled Protection of Children from Environmental Health Risks and 
    Safety Risks (62 FR 19885, April 23, 1997). This action does not 
    involve any technical standards that would require Agency consideration 
    of voluntary consensus standards pursuant to section 12(d) of the 
    National Technology Transfer and Advancement Act of 1995 (NTTAA), 
    Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
    tolerances and exemptions that are established on the basis of a FIFRA 
    section 18 petition under FFDCA section 408, such as the [tolerance/
    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. In addition, the Agency has 
    determined that this action will not have a substantial direct effect 
    on States, on the relationship between the national government and the 
    States, or on the distribution of power and responsibilities among the 
    various levels of government, as specified in Executive Order 13132, 
    entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
    13132 requires EPA to develop an accountable process to ensure 
    ``meaningful and timely input by State and local officials in the 
    development of regulatory policies that have federalism implications.'' 
    ``Policies that have federalism implications'' is defined in the 
    Executive Order to include regulations that have ``substantial direct 
    effects on the States, on the relationship between the national 
    government and the States, or on the distribution of power and 
    responsibilities among the various levels of government.'' This final 
    rule directly regulates growers, food processors, food handlers and 
    food retailers, not States. This action does not alter the 
    relationships or distribution of power and responsibilities established 
    by Congress in the preemption provisions of FFDCA section 408(n)(4).
    
    V. Submission to Congress and the General Accounting Office
    
        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 this final rule in the Federal Register. This final 
    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: November 9, 1999.
    
    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. 321(q), 346(a) and 371.
    
    Sec.  180.449  [Amended]
    
        2. In Sec.  180.449, by amending paragraph (b) in the table, for 
    the commodity ``celeriac,'' by revising the date ``1/31/00'' to read 
    ``12/31/00''.
    
    [FR Doc. 99-30409 Filed 11-19-99; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Effective Date:
11/22/1999
Published:
11/22/1999
Entry Type:
Rule
Action:
Final rule.
Document Number:
99-30409
Dates:
This regulation is effective November 22, 1999. Objections and requests for hearings, identified by docket control number OPP-300948, must be received by EPA on or before January 21, 2000.
Pages:
63709-63711 (3 pages)
Docket Numbers:
OPP-300948, FRL-6391-8
RINs:
2070-AB78
PDF File:
99-30409.pdf
CFR: (1)
40 CFR 180.449