[Federal Register Volume 60, Number 138 (Wednesday, July 19, 1995)]
[Rules and Regulations]
[Pages 37019-37020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17602]
[[Page 37019]]
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: [email protected]. 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:
[email protected].
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,
[[Page 37020]]
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-D[email protected]
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