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Anagrapha falcifera (Celery Looper) - Exemption of Tolerance Requirement 7/95

40 CFR Part 180
[PP 4F4402/R2149; FRL-4963-6]
RIN 2070-AB78
Inclusion Bodies of Multi-Nuclear Polyhedrosis Virus of Anagrapha
Falcifera; 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
inclusion bodies of the multi-nuclear polyhedrosis virus of Anagrapha
falcifera (celery looper) in or on all raw agricultural commodities.
Biosys requested this tolerance exemption that eliminates the need to
establish a maximum permissible level for residues of Anagrapha
falcifera multi-nuclear polyhedrosis virus.

EFFECTIVE DATE: This regulation becomes effective July 19, 1995.

ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 4F4402/R2149], may be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. 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. 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.
A copy of objections and hearing requests filed with the Hearing Clerk
may also be submitted electronically by sending electronic mail (e-mail)
to: opp-docket@epamail.epa.gov. Copies of objections and hearing
requests must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Copies of objections and hearing
requests will also be accepted on disks in WordPerfect in 5.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number [PP
4F4402/R2149]. No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic copies of objections and hearing
requests on this rule may be filed online at many Federal Depository
Libraries. Additional information on electronic submissions can be found
below in this document.

FOR FURTHER INFORMATION CONTACT: By mail: Linda Hollis, Biopesticides
and Pollution Prevention Division (7501W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location and telephone number: CS #1, 5th Floor, 2800 Crystal
Drive, Crystal City, VA 22202, (703) 308-8733; e-mail:
hollis.linda@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the Federal
Register of November 2, 1994 (59 FR 54902), which announced that Biosys,
Palo Alto, CA 94303, had submitted a pesticide petition, PP 4F4402, to
EPA requesting that the Administrator, pursuant to section 408(d) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), exempt
from the requirement of a tolerance the residues of the microbial pest
control agent inclusion bodies of the multi- nuclear polyhedrosis virus
of Anagrapha falcifera in or on all raw agricultural commodities when
used to control certain lepidopteran pest species.
No comments were received in response to the notice of filing.

Residue Chemistry Data

Residue chemistry data are necessary only if the submitted toxicology
studies indcate 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 considered in support of this exemption from the
requirement of a tolerance were satisfied via data waivers from the open
scientific literature with the exception of an acute oral toxicity
study. Waivers include an acute dermal toxicity study in the guinea pig,
an acute inhalation toxicity study in the rat, a primary eye irritation
study in the rabbit, and a cell culture study. 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 this low toxicity and lack
of pathogenicity or infectivity as reported in the open scientific
literature.
Based on the information cited above, the Agency concludes that the
establishment of a tolerance for the active ingredient Anagrapha
falcifera multi-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 to the regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed 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 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).
A record has been established for this rulemaking under docket number
[PP 4F4402/R2149] (including objections and hearing requests submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does not
include any information claimed as CBI, is available for inspection from
8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
The public record is located in Room 1132 of the Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2,
1921 Jefferson Davis Highway, Arlington, VA.
Written objections and hearing requests, identified by the document
control number [PP 4F4402/R2149], may be submitted to the Hearing Clerk
(1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW.,
Washington, DC 20460.
A copy of electronic objections and hearing requests filed with the
Hearing Clerk can be sent directly to EPA at:

opp-Docket@epamail.epa.gov

A copy of electronic objections and hearing requests filed with the
Hearing Clerk must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption.
The official record for this rulemaking, as well as the public version,
as described above will be kept in paper form. Accordingly, EPA will
transfer any objections and hearing requests received electronically
into printed, paper form as they are received and will place the paper
copies in the official rulemaking record which will also include all
objections and hearing requests submitted directly in writing. The
official rulemaking record is the paper record maintained at the address
in ADDRESSES at the beginning of this document.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency
must determine whether the regulatory action is "significant" and
therefore subject to all the requirements of the Executive Order (i.e.,
Regulatory Impact Analysis, review by the Office of Management and
Budget (OMB)). Under section 3(f), the order defines "significant" as
those actions likely to lead to 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 (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 this 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: July 3, 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. 180.1149, to read as follows:

Sec. 180.1149 Inclusion bodies of the multi-nuclear polyhedrosis virus
of Anagrapha falcifera; exemption from the requirement of a tolerance.

The microbial pest control agent inclusion bodies of the multi- nuclear
polyhedrosis virus of Anagrapha falcifera is exempted from the
requirement of a tolerance in or on all raw agricultural commodities
when used to control certain lepidopteran pest species.

[FR Doc. 95-17602 Filed 7-18-95; 8:45 am] BILLING CODE 6560-50-F