[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]
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