[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