[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