[Federal Register Volume 59, Number 56 (Wednesday, March 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6837]
[[Page Unknown]]
[Federal Register: March 23, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 2F4089/R2036; FRL-4753-2]
RIN 2070-AB78
Polyhedral Occlusion Bodies of Autographa Californica Nuclear
Polyhedrosis Virus; 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
Autographa californica nuclear polyhedrosis virus in or on all raw
agricultural commodities. The product Gusano is an insecticidal virus
product containing the polyhedral occlusion bodies of the naturally
occurring Autographa californica nuclear polyhedrosis virus (Family:
Baculoviridae). This tolerance exemption was requested by Crop Genetics
International. This regulation eliminates the need to establish a
maximum permissible level for residues of Autographa californica
nuclear polyhedrosis virus.
EFFECTIVE DATE: This regulation becomes effective March 23, 1994.
ADDRESSES: Written objections, identified by the document control
number, [PP 2F4089/R2036], may be submitted to: Hearing Clerk (A-110),
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 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: Phillip O. Hutton, Product
Manager (PM) 18, Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 207, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-7690.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 10, 1992 (57
FR 24645), EPA issued a notice that it had received PP 2F4089 from
Espro, Inc., requesting that 40 CFR part 180 be amended to establish a
tolerance for acal (the company and product, renamed ``Gusano,'' have
since been acquired by Crop Genetics International, 10150 Old Columbia
Rd., Columbia, MD 21046). Gusano contains the polyhedral occlusion
bodies of A. californica nuclear polyhedrosis virus and is proposed for
use in or on all raw agricultural commodities when used to control the
alfalfa looper.
No comments were received in response to the notice of filing.
Residue Chemistry Data
Although Gusano bioinsecticide will be applied on a variety of
vegetable and silvaculture crops at rates varying from 5 to 50 grams
per acre, residue chemistry data were not required. Such data were
determined to be necessary only if the submitted toxicology studies
indicate 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 requirements in support of this exemption from the
requirement of a tolerance were satisfied via data waivers from the
open scientific literature. These waivers include literature from an
acute oral toxicity/pathogenicity study in the rat, an acute pulmonary
toxicity/pathogenicity study in the rat, an acute dermal toxicity study
in the rabbit, and a primary eye irritation study in the rabbit.
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 the low
toxicity and lack of pathogenicity or infectivity as reported in the
open scientific literature.
Based on the information cited above, the Agency has determined
that the potential acute toxicity/pathogenicity of Autographa
californica nuclear polyhedrosis virus is sufficiently low to support
the proposed exemption from the requirement of a tolerance on all raw
agricultural commodities. Thus, a tolerance for the active ingredient
Autographa californica 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 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 or 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).
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 9, 1994.
Douglas D. Campt,
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. 180.1125, to read as follows:
Sec. 180.1125 Polyhedral occlusion bodies of Autographa californica
nuclear polyhedrosis virus; exemption from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
the microbial pest control agent Autographa californica nuclear
polyhedrosis virus in or on all raw agricultural commodities.
[FR Doc. 94-6837 Filed 3-22-94; 8:45 am]
BILLING CODE 6560-50-F
