[Federal Register Volume 60, Number 16 (Wednesday, January 25, 1995)]
[Notices]
[Pages 4910-4911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1857]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-30106; FRL-4934-2]
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. tenebrionis (B.t.t) delta endotoxin
produced in potatoes 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 potatoes planted, the amount of
delta-endotoxin produced, and the subsequent harvesting and processing
of the resulting crop. EPA is proposing to issue this limited
registration because the intent of the plantings is to increase
reproductive plant materials.
DATES: Comments identified by the docket control number [OPP-30106]
must be received on or before February 24, 1995.
ADDRESSES: By mail: Submit written comments identified by the document
control number [OPP-30106] 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.
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 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.,
[[Page 4911]] 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.
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. 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). 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 potatoes
producing Bacillus thuringiensis var. tenebrionis (B.t.t.) delta
endotoxin for the purpose of increasing propagative materials. The
information and data evaluated by the Agency to date has led EPA to
conclude that, under the restrictions of the limited registration,
there will be no unreasonable adverse effects to humans or the
environment.
Therefore, EPA is proposing to issue the following limited
registration:
524-474. Monsanto Company, 700 Chesterfield Parkway North, St.
Louis, MO 63198. The approved limited registration for plant
propagation would allow the use of 4,988.9 grams of Bacillus
thuringiensis cryIIIc delta endotoxin produced in potato plants grown
from both tubers and plantlets over a total of 8,186 acres. Planting of
the product would be limited to the states of Colorado, Idaho, Maine,
Michigan, Minnesota, Montana, Nebraska, New York, North Dakota, Oregon,
Washington, and Wisconsin. The registration would be limited to
plantings from March 1, 1995 through January 1, 1995, and would include
associated agronomic activities such as the harvesting and processing
of plant propagative materials. Sale or distribution of the crop or
plant propagative materials would be prohibited. This registration
would also be limited in that all crops must be either destroyed or
stored for future plantings or research.
Interested parties should note that EPA will be holding a meeting
of the Scientific Advisory Panel on March 1, 1995, for consideration of
a full registration under FIFRA section 3(c)(5) (i.e., a registration
not restricted to propagation, and unlimited acreage) for this product.
The scientific merits of a proposed exemption from the requirement of a
tolerance will also be discussed at this meeting.
List of Subjects
Environmental protection, Biotechnology, Plant-pesticide,
Pesticides, Plants, Registration.
Dated: January 19, 1995.
Daniel Barolo,
Director, Office of Pesticide Programs.
[FR Doc. 95-1857 Filed 1-24-95; 8:45 am]
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