[Federal Register Volume 60, Number 31 (Wednesday, February 15, 1995)]
[Notices]
[Pages 8657-8658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-3761]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-30108; FRL-4937-5]
Notice of Limited Plant Propagation Registration for a Plant-
Pesticide
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is proposing to issue a limited plant propagation
registration under section 3(c)(5) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) to Monsanto Company for the
Bacillus thuringiensis var. kurstaki (B.t.k.) delta endotoxin produced
in cotton for the purpose of increasing reproductive plant materials
(plant propagation/seed production). This limited plant propagation
registration will be restricted as to the duration of the registration,
time and acreage of cotton planted, containment of field plots, and the
subsequent harvesting and processing of the resulting crop.
DATES: Comments identified by the docket control number [OPP-30108]
must be received on or before March 17, 1995.
ADDRESSES: By mail: Submit written comments identified by the document
control number [OPP-30108] 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, Attention: Phil Hutton. In person bring comments to: Rm.
1132, CM #2, 1921 Jefferson Davis Highway, Arlington, VA, (703) 305-
5805.
Information submitted as a comment concerning this notice may be
claimed confidential by marking any part or all of the 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 at the time of submission 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 holidays.
FOR FURTHER INFORMATION CONTACT: Phil Hutton, Biopesticides and
Pollution Prevention Division (7501W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Telephone number: (703) 308-8260.
SUPPLEMENTARY INFORMATION: EPA has received several requests for
experimental use permits for plant-pesticides which include acreage
dedicated solely to seed increase. Because plant-pesticides are
produced in living plants, their commercial development involves the
propagation and breeding of new varieties of the crops producing the
plant-pesticides. This plant breeding process also involves increases
of plant reproductive materials prior to commercialization. The
production of propagative plant products (such as seeds, tubers, corms,
cuttings, etc.) is an integral step in the development of new
commercial plant varieties. Because of the biology of plants and
general planting and harvesting restrictions associated with plant
propagation, this step usually takes an entire year in the product
development cycle. In the case of tree crops, it may take much
longer. [[Page 8658]]
EPA has considered procedural options under FIFRA which would allow
plant-pesticides to be propagated for the production of reproductive
plant materials under limited acreage and conditions in instances where
the Agency has determined that such plant propagation will not result
in unreasonable adverse effects to humans or the environment. EPA has
determined that a limited registration under section 3(c)(5) is an
appropriate regulatory vehicle for pesticides produced in plants grown
for the purposes of plant propagation/seed increase. A limited
registration will stipulate the conditions under which the plantings
could occur and may include such restrictions as the acreage to be
planted, the design of the field sites to ensure adequate containment,
the locations of the field sites, and any other restrictions deemed
necessary including restrictions on the sale and distribution of the
crop. The Agency, in making its finding of no unreasonable adverse
effects, will rely in part upon the restrictions set in the limited
registration. The limited registration will also stipulate that the
company acquiring the registration is liable for the actions of its
cooperators in terms of meeting the conditions of the registration.
Companies that wish to make applications for a limited registration
under FIFRA section 3(c)(5) for the purposes of plant propagation/seed
production should be cognizant of tolerance requirements under the
Federal Food, Drug, and Cosmetic Act (FFDCA). Where food or feed crops
are involved, crop destruction or other actions to prevent the
introduction of the resulting crop into commerce will be a necessary
condition of a limited registration in the absence of a tolerance or
exemption from the requirement of a tolerance. Moreover, seeds or other
plant parts may be restricted in their sale or distribution.
Monsanto has requested a limited registration for plant propagation
and has proposed certain conditions for the registration. The Agency
has evaluated the information and data that have been submitted by
Monsanto concerning the potential risks from planting cotton producing
Bacillus thuringiensis var. kurstaki (B.t.k.) delta endotoxin for the
purpose of increasing propagative materials. The information and data
evaluated by the Agency to date has led EPA to preliminarily conclude
that, under the restrictions of the limited registration, there are no
foreseeable unreasonable adverse effects to humans or the environment.
Copies of information submitted to the Agency in support of this
registration will be available from the public docket. The release of
data is subject to section 10(g) of FIFRA; disclosure requires
submission of a signed Affirmation of Non-multinational Status form. To
receive a copy of the form contact the OPP docket staff at the address
or telephone number listed under the ADDRESSES unit. Due to the volume
of data, callers will receive the data on microfiche. A papercopy of
the data is available for viewing in the docket.
Therefore, EPA is proposing to issue the following limited
registration:
524-UTI. Monsanto Company, 700 Chesterfield Parkway North, St.
Louis, MO 63198. The approved limited registration for plant
propagation would allow the use of the Bacillus thuringiensis var.
kurstaki delta endotoxin as produced by the Cry 1 A(c) gene and its
controlling sequences in cotton plants over a total of 36,850 acres.
Planting of the product would be limited to the states of Arizona,
Arkansas, California, Mississippi, South Carolina, and Texas and the
territory of Puerto Rico. The registration would be limited to
plantings from March 15, 1995 through December 15, 1995, and would
include associated agronomic activities such as the harvesting and
processing of plant propagative material. Sale or distribution of the
crop or plant propagative materials would be prohibited. This
registration would be limited in that containment of the field sites to
prevent outcrossing to other cotton would consist of the use of
isolation distances and/or buffer rows of non-transgenic cotton. This
registration would be also be limited in that all crops would either be
destroyed or stored for future plantings or research. The field sites
would be monitored for 12 months for germinating seed which would be
destroyed.
Interested parties should note that in the Federal Register of
January 25, 1995 (60 FR 4910), and February 8, 1995 (60 FR 7538), EPA
announced a March 1, 1995 meeting of the Scientific Advisory Panel for
consideration of scientific issues related to this registration.
List of Subjects
Environmental protection, Biotechnology, Plant-pesticide,
Pesticides, Plants, Registration.
Dated: February 8, 1995.
Janet L. Andersen,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
[FR Doc. 95-3761 Filed 2-14-95; 8:45 am]
BILLING CODE 6560-50-F
