[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]
BILLING CODE 6560-50-F