[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.P<a href="/cdn-cgi/l/email-protection#1170656378727870517461707c70787d3f7461703f767e67"><span class="__cf_email__" data-cfemail="a0c1d4d2c9c3c9c1e0c5d0c1cdc1c9cc8ec5d0c18ec7cfd6">[email protected]</span></a>.

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

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