[Federal Register Volume 59, Number 114 (Wednesday, June 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14423]


[[Page Unknown]]

[Federal Register: June 15, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 3E4255/P583; FRL-4866-4]
RIN 2070-AC18

 

Pseudomonas Fluorescens Strain NCIB 12089; Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to establish an exemption from the requirement of 
a tolerance for residues of Pseudomonas fluorescens in or on the raw 
agricultural commodity mushrooms. This exemption from the requirement 
of a tolerance was requested in a petition submitted by the 
Interregional Research Project No. 4 (IR-4).
DATES: Comments, identified by the document control number [PP 3E4255/
P583], must be received on or before July 15, 1994.

ADDRESSES: By mail, submit written comments 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 comments to: Rm. 1132, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA 22202.
    Information submitted as a comment concerning this notice may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). Information so marked will 
not be disclosed except in accordance with procedures set forth in 40 
CFR part 2. A copy of the comment that does not contain CBI must be 
submitted for inclusion in the public record. Information not marked 
confidential may be disclosed publicly by EPA without prior notice. All 
written comments will be available for public inspection in Rm. 1132 at 
the address given above, from 8 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Hoyt L. Jamerson, 
Registration Division (7505W), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location and telephone number: Sixth Floor, Crystal Station #1, 
2800 Jefferson Davis Hwy., Arlington, VA 22202, (703)-308-8783.

SUPPLEMENTARY INFORMATION: The Interregional Research Project No. 4 
(IR-4), New Jersey Agricultural Experiment Station, P.O. Box 231, 
Rutgers University, New Brunswick, NJ 08903, has submitted pesticide 
petition (PP) 3E4255 to EPA on behalf of the State Agricultural 
Experiment Stations and the United States Department of Agriculture. 
This petition requests that the Administrator, pursuant to section 
408(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 
346a(e), establish an exemption from the requirement of a tolerance for 
residues of the biological pesticide Pseudomonas fluorescens strain 
NCIB 12089, in or on the raw agricultural commodity mushrooms. The 
proposed use of the biological pesticide is to control bacterial blotch 
of cultivated mushrooms.
    Pseudomonas fluorescens is a naturally occurring bacterium, is the 
dominant microflora found in mushroom caps, and is found in tap and 
fresh water, marine environments, and plants. It is reasonable to 
assume that most people are exposed daily to this bacterium. 
Pseudomonas fluorescens has been marketed for several years in 
Australia for mushroom blotch control.
    The scientific data submitted in the petition and all other 
relevant material have been evaluated. An acute oral toxicity test 
indicated that Pseudomonas fluorescens strain NCIB 12089 was not toxic 
or pathogenic to rats by the oral route of exposure. Tests of various 
Pseudomonas strains closely related to those considered in the petition 
have been conducted. Acute oral, acute injection, and acute inhalation 
tests indicated that the related strains tested were not lethal or 
toxic to rats. Primary eye and primary dermal studies in rabbits using 
closely related strains showed no significant irritation effects.
    Growth temperature studies were conducted for Pseudomonas 
fluorescens strain NCIB 12089 between 25 degrees and 37 degrees 
Centigrade (C). These studies demonstrated that this bacterial strain 
does not thrive at mammalian body temperatures (above 35 degrees C). 
This information, along with the toxicity infectivity tests, indicates 
that this organism is not a human pathogen. None of the members of this 
biotype of Pseudomonas fluorescens have been shown to be involved in 
mammalian pathogenicity or capable of forming toxic or sensitizing 
substances.
    Reference Dose (RfD) considerations are not relevant to this 
petition; the available data indicate that this biological agent is not 
toxic to humans. Since no tolerance level will be set for this 
microbial control agent, the requirement for an analytical method for 
enforcement purposes is not applicable to this exemption from the 
requirement of a tolerance.
    Based on the information and data considered, the Agency has 
determined that a tolerance is not needed to protect the public health. 
Therefore, it is proposed that the exemption from the requirement of a 
tolerance be established as set forth below.
    Any person who has registered or submitted an application for 
registration of a pesticide, under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA) as amended, which contains any of the 
ingredients listed herein, may request within 30 days after publication 
of this notice in the Federal Register that this rulemaking proposal be 
referred to an Advisory Committee in accordance with section 408(e) of 
the FFDCA.
    Interested persons are invited to submit written comments on the 
proposed regulation. Comments must bear a notation indicating the 
document control number, [PP 3E4255/P583]. All written comments filed 
in response to this petition will be available in the Public Response 
and Program Resources Branch, at the address given above from 8 a.m. to 
4 p.m., Monday through Friday, except legal holidays.
    Under Executive Order 12866 (58 FR 51735, Oct. 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: May 30, 1994.

Stephanie R. Irene,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR part 180 be 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. By adding new Sec. 180.1129 to subpart D, to read as follows:


Sec. 180.1129   Pseudomonas fluorescens strain NCIB 12089; exemption 
from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the biological pesticide Pseudomonas fluorescens strain 
NCIB 12089 in or on mushrooms.

[FR Doc. 94-14423 Filed 6-14-94; 8:45 am]
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