[Federal Register Volume 59, Number 211 (Wednesday, November 2, 1994)]
[Proposed Rules]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-26800]


[[Page Unknown]]

[Federal Register: November 2, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4F4387/P592; FRL-4915-7]
RIN 2070-AC18
 

Pasteuria Penetrans; Proposed Exemption from the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.

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SUMMARY: EPA proposes establishing an exemption from the requirement of 
a tolerance for residues of the biological pesticide Pasteuria 
penetrans in or on all raw agricultural commodities when used as a 
nematicide in producing fruits and vegetables, except roots and tubers, 
in greenhouses. Walt Disney World Co. requested this exemption.

DATES: Comments, identified by the document control number, [PP 4F4387/
P592], must be received on or before December 2, 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. Office location and telephone number: In person, 
bring comments to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., 
Arlington, VA 22202.
    Information submitted as a comment concerning this document 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: Leonard S. Cole, Acting 
Product Manager (PM 21), Registration Division (7505C), Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location and telephone number: Rm. 227, CM #2, 1921 Jefferson Davis 
Hwy., Arlington, VA 22202, (703)-305-6900.

SUPPLEMENTARY INFORMATION: EPA received from Walt Disney World Co., 
P.O. Box 10000, Lake Buena Vista, FL 32830, pesticide petition (PP) 
4F4387 on July 14, 1994, proposing to amend 40 CFR part 180 by 
establishing a regulation under the Federal Food, Drug and Cosmetic 
Act, 21 U.S.C. 346a, to exempt from the requirement of a tolerance the 
residues of the biological pesticide Pasteuria penetrans in or on all 
raw agricultural commodities when used as a nematicide in producing 
fruits and vegetables (other than vegetables whose roots or tubers are 
considered to be food items) in greenhouses at The Land in EPCOT Center 
at Walt Disney World. This petition is not associated with an 
application for pesticide registration. The establishment of this 
tolerance exemption would not relieve manufacturers, distributors, or 
sellers of this pesticide of any obligation they may have under the 
Federal Insecticide, Fungicide and Rodenticide Act, 7 U.S.C. 136 et 
seq.
    Pasteuria penetrans is a naturally occurring soil microbe that is a 
parasite of species of the nematode genus Meloidogyne. Pasteuria 
penetrans reproduces by means of endospores which remain dormant in the 
soil until contacted by a migrating juvenile nematode. The spore 
attaches itself to the nematode and is carried by the nematode into a 
plant root. The endospore germinates and invades the body of the 
nematode where it eventually produces new endospores that are released 
into the soil following the death of the nematode and decomposition of 
root tissue. The infected nematodes do not produce eggs and therefore 
do not reproduce.
    The information submitted in support of this petition and all other 
relevant material have been evaluated. Literature citations regarding 
the nature of this organism were considered adequate to support an 
exemption from the requirement of a tolerance for the limited use of 
this biological pesticide. Additionally, since Pasteuria penetrans can 
only be grown in association with the host nematode, it is not possible 
to conduct standard toxicological tests with this organism.
    Pasteuria penetrans is not known to be pathogenic, infective, or 
toxic to humans. The specificity of the organism as a parasite only on 
nematodes of the genus Meloidogyne would make it extremely unlikely to 
infect any other unrelated organism. Pasteuria penetrans is a common 
inhabitant of soils in areas infested with nematodes, including the 
area of Florida where the organism will be used. The microorganism will 
only be applied to the soil in greenhouses, and use in this manner 
would result in its presence only in the soil and roots of plants grown 
in the greenhouses. The proposed exemption excludes plant roots which 
will be used for food purposes since the nematode and the associated 
parasite will be contained in the root portion of such plants. Since 
there are no data available regarding any possible effects from the 
consumption of elevated levels of either nematodes or their parasites, 
roots and tubers which may contain these organisms have been excluded 
from this exemption from tolerance requirements. Above-ground parts of 
plants harvested from treated soil would not be expected to contain 
levels of Pasteuria penetrans above that normally found in crops 
harvested under natural conditions and consumed on a daily basis. The 
information submitted is adequate to show that there are no forseeable 
human or domestic health hazards likely to arise from the use of the 
product as a nematicide in connection with the production of fruits and 
vegetables in greenhouses.
    Although the submitted petition for an exemption from tolerance 
requirements for Pasteuria penetrans limited the use of the organism to 
greenhouses at The Land in EPCOT Center at Walt Disney World, the 
Agency believes that this limitation is overly restrictive. Based on 
the lack of any known hazards from the use of this organism in the 
manner described, the Agency has elected not to impose a geographic 
restriction for the use of this biological nematicide. Pasteuria 
penetrans is considered useful for the purpose for which the exemption 
from the requirement of a tolerance is sought. Based on the information 
considered, the Agency concludes that establishment of the exemption 
will protect the public health. Therefore, the regulation is proposed 
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 document 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 4F4387/P592]. All written comments filed 
in response to these petitions 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, or establishing or raising food additive regulations 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: October 14, 1994.

Steven L. Johnson,
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. In subpart D, by adding new Sec. 180.1135, to read as follows:


Sec. 180.1135   Pasteuria penetrans; exemption from the requirement of 
a tolerance.

    The biological nematicide Pasteuria penetrans is exempted from the 
requirement of a tolerance in or on all raw agricultural commodities, 
except roots and tubers, when used as a nematicide in the production of 
fruits and vegetables in greenhouses.

[FR Doc. 94-26800 Filed 11-1-94; 8:45 am]
BILLING CODE 6560-50-F