95-7452. Beauveria Bassiana Strain GHA; Exemption From the Requirement of a Tolerance  

  • [Federal Register Volume 60, Number 57 (Friday, March 24, 1995)]
    [Rules and Regulations]
    [Pages 15486-15488]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 95-7452]
    
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    40 CFR Part 180
    
    [PP 4F4318/R2118; FRL-4943-9]
    RIN 2070-AB78
    
    
    Beauveria Bassiana Strain GHA; 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 
    tolerance for residues of Beauveria bassiana Strain GHA in or on 
    alfalfa, corn, cotton, potatoes, rapeseed, safflower, small grain 
    crops, soybeans, sugarbeets, sunflower, rangeland, improved pastures, 
    and in meat, milk, or other animal products from livestock grazed on 
    treated rangeland or improved pastures when applied to growing crops in 
    accordance with good agricultural practices. Mycotech Corp. requested 
    this exemption.
    
    EFFECTIVE DATE: March 10, 1995.
    
    ADDRESSES: Written objections, identified by the document control 
    number, [PP 4F4318/R2118], may be submitted to: Hearing Clerk (1900), 
    Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, 
    DC 20460. 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. Fees 
    accompanying objections shall be labeled ``Tolerance Petition Fees'' 
    and [[Page 15487]] forwarded to: EPA Headquarters Accounting Operations 
    Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251.
    
    FOR FURTHER INFORMATION CONTACT: By mail: Patricia A. Cimino, 
    Biopesticides and Pollution Prevention Division (7501W), Office of 
    Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
    Washington, DC 20460, (703)-308-7035; e-mail: 
    Cimino.Patricia@epamail.epa.gov.
    
    SUPPLEMENTARY INFORMATION: In the Federal Register of July 13, 1994 (59 
    FR 35718), EPA issued a notice that Mycotech Corp., 630 Utah Drive, 
    P.O. Box 4109, Butte, MT 59701, had submitted pesticide petition (PP) 
    4F4318 proposing to amend 40 CFR part 180 by establishing a regulation 
    pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act 
    (FFDCA), 21 U.S.C. 346a(d), to exempt from the requirement of a 
    tolerance the residues of the microbial pest control agent Beauvaria 
    bassiana Strain GHA in or on alfalfa, corn, cotton, potatoes, rapeseed, 
    safflower, small grain crops, soybeans, sugarbeets, sunflower, 
    rangeland, improved pastures, and in meat, milk, or other animal 
    products from livestock grazed on treated rangeland or improved 
    pastures when applied to growing crops in accordance with good 
    agricultural practices. In the Federal Register of February 8, 1995 (60 
    FR 7543), EPA issued a notice of amendment to PP 4F4318 to establish a 
    regulation to exempt from the requirement of a tolerance residues of 
    the insecticide Beauvaria bassiana Strain GHA in or on all raw 
    agricultural commodities.
        There were no comments received in response to the notices of 
    filing.
        Beauveria bassiana Strain GHA is naturally occurring and was 
    originally isolated from indigenous grasshoppers.
        The data submitted in the petition and all other relevant material 
    have been evaluated. The toxicological data considered in support of 
    the exemption from the requirement of a tolerance for Beauveria 
    bassiana Strain GHA in or on rangeland, improved pastures, meat, milk, 
    or other animal products from livestock grazed on treated rangeland or 
    improved pastures, alfalfa, corn, potatoes, rapeseed, safflower, small 
    grain crops, soybeans, sugarbeets, and sunflower include an acute oral 
    toxicity/pathogenicity study, an acute dermal toxicity study, an acute 
    pulmonary toxicity/pathogenicity study, an acute intraperitoneal 
    toxicity/pathogenicity study, and primary eye irritation studies.
        The results of these studies indicated that the organism was not 
    toxic to test animals when administered via oral, dermal, pulmonary, or 
    intraperitoneal routes.
        The active ingredient was not infective or pathogenic to the test 
    animals in any of the studies. Ocular lesions were observed in the eye 
    irritation study with the technical-grade active ingredient (TGAI) and 
    resulted in a Toxicity Category I rating. Minimal ocular irritation was 
    observed in the eye irritation studies done with oil-flowable and 
    emulsifiable suspension end-use product formulations indicating that 
    the lesions observed in the eye irritation test done with TGAI may have 
    been due to physical effects of the TGAI. Slight skin irritation 
    persisted in test animals treated with the TGAI resulting in a Toxicity 
    Category III rating. There have been no reports of hypersensitivity 
    related to the active ingredient. All of the toxicity studies submitted 
    are considered acceptable.
        The toxicology data provided are sufficient to demonstrate that 
    there are no foreseeable human health hazards likely to arise from use 
    of Beauveria bassiana Strain GHA on the requested food and feed 
    commodities when applied during the growing season in accordance with 
    good agricultural practices.
        Acceptable daily intake (ADI) and maximum permissible intake (MPI) 
    considerations are not relevant to this petition because the data 
    submitted demonstrated that this biological control agent is not toxic 
    to humans by dietary exposure. No enforcement actions are expected 
    based on a level of residues in food. Therefore, the requirement for an 
    analytical method for enforcement purposes is not applicable to this 
    exemption request. This is the first exemption from the requirement of 
    a tolerance for this microbial pest control agent.
        Based on the information considered, the Agency concludes that 
    establishment of a tolerance is not necessary to protect the public 
    health. Therefore, the exmeption from tolerance is established 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 and/or request a hearing 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 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 issue(s) in the manner 
    sought by the requestor would be adequate to justify the action 
    requested (40 CFR 178.32).
        Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency 
    must determine whether the regulatory action is ``significant'' and 
    therefore subject to review by the Office of Management and Budget 
    (OMB) and the requirements of the Executive Order. Under section 3(f), 
    the order defines a ``significant regulatory action'' as an action that 
    is likely to result in 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 referred to 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 the rights and obligations of recipients 
    thereof; 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 the 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). [[Page 15488]] 
    
    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 10, 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. 180.1146, to read as follows:
    
    
    Sec. 180.1146 Beauveria bassiana Strain GHA; exemption from the 
    requirement of a tolerance.
    
        Beauveria bassiana Strain GHA is exempted from the requirement of a 
    tolerance in or on alfalfa, corn, cotton, potatoes, rapeseed, 
    safflower, small grain crops, soybeans, sugarbeets, sunflower, 
    rangeland, and improved pastures and in meat, milk, or other animal 
    products from livestock grazed on treated rangeland or improved 
    pastures when applied to growing crops according to good agricultural 
    practices.
    
    [FR Doc. 95-7452 Filed 3-22-95; 12:28 pm]
    BILLING CODE 6560-50-F
    
    

Document Information

Effective Date:
3/10/1995
Published:
03/24/1995
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
95-7452
Dates:
March 10, 1995.
Pages:
15486-15488 (3 pages)
Docket Numbers:
PP 4F4318/R2118, FRL-4943-9
RINs:
2070-AB78
PDF File:
95-7452.pdf
CFR: (1)
40 CFR 180.1146