95-17602. Inclusion Bodies of Multi-Nuclear Polyhedrosis Virus of Anagrapha Falcifera; Exemption From the Requirement of a Tolerance  

  • [Federal Register Volume 60, Number 138 (Wednesday, July 19, 1995)]
    [Rules and Regulations]
    [Pages 37019-37020]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 95-17602]
    
    
    
    
    [[Page 37019]]
    
    
    40 CFR Part 180
    
    [PP 4F4402/R2149; FRL-4963-6]
    RIN 2070-AB78
    
    
    Inclusion Bodies of Multi-Nuclear Polyhedrosis Virus of Anagrapha 
    Falcifera; Exemption From the Requirement of a Tolerance
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Final rule.
    
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    SUMMARY: This rule establishes an exemption from the requirement of a 
    pesticide tolerance for residues of the microbial pest control agent 
    inclusion bodies of the multi-nuclear polyhedrosis virus of Anagrapha 
    falcifera (celery looper) in or on all raw agricultural commodities. 
    Biosys requested this tolerance exemption that eliminates the need to 
    establish a maximum permissible level for residues of Anagrapha 
    falcifera multi-nuclear polyhedrosis virus.
    
    EFFECTIVE DATE: This regulation becomes effective July 19, 1995.
    
    ADDRESSES: Written objections and hearing requests, identified by the 
    document control number, [PP 4F4402/R2149], may be submitted to: 
    Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M 
    St., SW., Washington, DC 20460. 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. 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.
        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.epa.gov. Copies of 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 in 5.1 
    file format or ASCII file format. All copies of objections and hearing 
    requests in electronic form must be identified by the docket number [PP 
    4F4402/R2149]. No Confidential Business Information (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. Additional information on electronic submissions can be 
    found below in this document.
    
    FOR FURTHER INFORMATION CONTACT: By mail: Linda Hollis, Biopesticides 
    and Pollution Prevention Division (7501W), Office of Pesticide 
    Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
    DC 20460. Office location and telephone number: CS #1, 5th Floor, 2800 
    Crystal Drive, Crystal City, VA 22202, (703) 308-8733; e-mail: 
    hollis.linda@epamail.epa.gov.
    
    SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the 
    Federal Register of November 2, 1994 (59 FR 54902), which announced 
    that Biosys, Palo Alto, CA 94303, had submitted a pesticide petition, 
    PP 4F4402, 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), exempt from the requirement of a tolerance the residues 
    of the microbial pest control agent inclusion bodies of the multi-
    nuclear polyhedrosis virus of Anagrapha falcifera in or on all raw 
    agricultural commodities when used to control certain lepidopteran pest 
    species.
        No comments were received in response to the notice of filing.
    
    Residue Chemistry Data
    
        Residue chemistry data are necessary only if the submitted 
    toxicology studies indcate that additional Tier II or III toxicology 
    data would be required as specified in 40 CFR 158.165(e). The submitted 
    toxicology data for this use indicate that the product is of low 
    mammalian toxicity; therefore, Tier II or III data were not required.
    
    Toxicology Data
    
        Toxicology data considered in support of this exemption from the 
    requirement of a tolerance were satisfied via data waivers from the 
    open scientific literature with the exception of an acute oral toxicity 
    study. Waivers include an acute dermal toxicity study in the guinea 
    pig, an acute inhalation toxicity study in the rat, a primary eye 
    irritation study in the rabbit, and a cell culture study. Findings from 
    the open scientific literature showed no toxic, pathogenic, or adverse 
    effects.
        Reference Dose (RfD) and maximum permissible intake (MPI) 
    considerations are not relevant to this petition because of this low 
    toxicity and lack of pathogenicity or infectivity as reported in the 
    open scientific literature.
        Based on the information cited above, the Agency concludes that the 
    establishment of a tolerance for the active ingredient Anagrapha 
    falcifera multi-nuclear polyhedrosis virus is not necessary to protect 
    the public health. Therefore, 40 CFR part 180 is amended 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 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).
         A record has been established for this rulemaking under docket 
    number [PP 4F4402/R2149] (including objections and hearing requests 
    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, 
    
    [[Page 37020]]
    1921 Jefferson Davis Highway, Arlington, VA.
        Written objections and hearing requests, identified by the document 
    control number [PP 4F4402/R2149], may be submitted to the Hearing Clerk 
    (1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW., 
    Washington, DC 20460.
        A copy of electronic objections and hearing requests filed with the 
    Hearing Clerk can be sent directly to EPA at:
    
        opp-Docket@epamail.epa.gov
    
        A copy of electronic objections and hearing requests filed with the 
    Hearing Clerk must be submitted as an ASCII file avoiding the use of 
    special characters and any form of encryption.
        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 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 objections and hearing requests submitted directly in 
    writing. The official rulemaking record is the paper record maintained 
    at the address in ADDRESSES at the beginning of this document.
        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: July 3, 1995.
    
    Daniel M. Barolo,
    Director, 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 subpart D, by adding new Sec. 180.1149, to read as follows:
    
    
    Sec. 180.1149   Inclusion bodies of the multi-nuclear polyhedrosis 
    virus of Anagrapha falcifera; exemption from the requirement of a 
    tolerance.
    
        The microbial pest control agent inclusion bodies of the multi-
    nuclear polyhedrosis virus of Anagrapha falcifera is exempted from the 
    requirement of a tolerance in or on all raw agricultural commodities 
    when used to control certain lepidopteran pest species.
    
    [FR Doc. 95-17602 Filed 7-18-95; 8:45 am]
    BILLING CODE 6560-50-F
    
    

Document Information

Effective Date:
7/19/1995
Published:
07/19/1995
Entry Type:
Rule
Action:
Final rule.
Document Number:
95-17602
Dates:
This regulation becomes effective July 19, 1995.
Pages:
37019-37020 (2 pages)
Docket Numbers:
PP 4F4402/R2149, FRL-4963-6
RINs:
2070-AB78
PDF File:
95-17602.pdf
CFR: (1)
40 CFR 180.1149