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B. bassiana - Exemption from Tolerance for Residues 4/95

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 4F4318/R2118; FRL-4945-2]
RIN 2070-AB78

Beauveria Bassiana Strain GHA; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule establishes an exemption from the requirement for a
tolerance for residues of Beauveria bassiana Strain GHA in or on all
raw agricultural commodities. Mycotech Corp. requested this exemption.

EFFECTIVE DATE: This regulation becomes effective April 12, 1995.

ADDRESSES: Written objections, identified by the document control
number, [PP4F4318/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 a copy of objections and hearing request to Rm. 1132,
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. 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.

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 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 Beauveria
bassiana Strain GHA in or on alfalfa, corn, 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.  There were no comments received in response to
the notice of filing.

In the Federal Register of February 8, 1995 (60 FR 7543), EPA
issued a notice that Mycotech Corp., 630 Utah Drive, P.O. Box 4109,
Butte, MT 59701, had submitted an amendment to a pesticide petition, PP
4F4318, proposing to amend 40 CFR part 180 by establishing a regulation
pursuant to section 408 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 Beauveria
bassiana Strain GHA in or on all raw agricultural commodities.

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 all raw agricultural crops 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 studies with the technical-grade active ingredient (TGAI)
and a wettable powder (WP) formulation and resulted in a Toxicity
Category I rating for these products. 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 tests done with TGAI and the
WP formulations may have been due to physical effects of the TGAI and
inert ingredients. 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
[[Page 18547]] 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
second exemption from the requirement of a tolerance for this microbial
pest control agent. The first exemption appeared in the Federal
Register of March 24, 1990 (60 FR 15488).

Based on the information considered, the Agency concludes that
establishment of a tolerance is not necessary to protect the public
health. Therefore, the exemption 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 and the relief sought (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 issues(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 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 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 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, Pesticide and pests, Reporting and
recordkeeping requirements.

    Dated: March 29, 1995.

Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.

PART 180--[AMENDED]

    Therefore, 40 CFR part 180 is amended as follows:
    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 revising 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 all raw agricultural commodities when applied to
growing crops according to good agricultural practices.

[FR Doc. 95-8727 Filed 4-11-95; 8:45 am]
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