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Pasteuria Penetrans; Proposed Exemption from the Requirement of a Tolerance
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[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]
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