[Federal Register Volume 60, Number 40 (Wednesday, March 1, 1995)]
[Notices]
[Pages 11094-11095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4757]



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ENVIRONMENTAL PROTECTION AGENCY
[OPP-50806; FRL-4937-7]


Receipt of an Application for an Experimental Use Permit of a 
Transgenic Plant Pesticide

Agency: Environmental Protection Agency (EPA).

Action: Notice.

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Summary: EPA has received an application (65247-EUP-R) from Calgene, 
Inc., of Davis, California, requesting an Experimental Use Permit (EUP) 
to conduct field testing of a transgenic plant pesticide. The first EUP 
for field testing of a genetically altered cotton plant having 
pesticidal properties was issued on April 10, 1992. EPA has determined 
that this permit may be of regional and national significance.

DATES: Written comments must be received on or before March 31, 1995.

ADDRESSES: Comments, in triplicate should bear the docket control 
number OPP-50806 and be submitted 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. In person bring comments to: Rm. 1128, Crystal 
Mall #2, 1921 Jefferson Davis Highway, Crystal City, VA 22202.
    Information submitted in any comment concerning this notice 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 to 
the submitter. Written comments will be available for public inspection 
in Rm. 1128 at the address given above, from 8 a.m. to 4:30 p.m., 
Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Janet L. Andersen, Acting 
Director, Biopesticides and Pollution Prevention Division (7501W), 
Office of Pesticide Programs, Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460. Office location and telephone number: 
CS1 5th floor, 2800 Crystal Drive, Crystal City, VA 22202 (703-308-
8712).

SUPPLEMENTARY INFORMATION: An application for an EUP pursuant to EPA's 
Statement of Policy entitled ``Microbial Products Subject to the 
Federal Insecticide, Fungicide, and Rodenticide Act and the Toxic 
Substances Control Act'', published in the Federal Register of June 26, 
1986 (51 FR 23313), was received on January 17, 1995, from Calgene, 
Inc. of Davis, California (65247-EUP-R).
    Calgene, Inc. proposes to experiment in the field for 1 year, 
beginning April 1, 1995, with a transgenic insect resistant cotton 
plant which expresses a Bacillus thuringiensis subsp. kurstaki (B.t.k.) 
cryIA(c) segment within the plant cells. Bacillus thuringiensis subsp. 
kurstaki protein will be present at no more than .001 percent of the 
total weight of the cottonseed. The cryIA(c) gene of Bacillus 
thuringiensis is transferred to cotton via the Ti plasmid of 
Agrobacterium tumefaciens, a vector system which has been used to 
stably transform many plant pesticides. All transgenic plants to be 
used in this field trial are upland cotton Gossypium hirsutum.
    The 1995 Program as proposed by Calgene, Inc. will include four 
types of field trials. Target lepidopteran pests include: Helicoverpa 
zea (Cotton bollworm); Pectinophora gossypiella (Pink bollworm); 
Heliothis virescens (Tobacco budworm); Spodoptera exigua (Beet 
armyworm), Spodoptera frugiperda (Fall armyworm) and other lepidopteran 
insects pest of cotton. A total of 2,460 pounds of transgenic 
cottonseed will be planted on 0.5 to 20 acre sites for a total of 164 
acres. The total amount of active ingredient used for 164 acres will be 
11.3 grams, the amount of active ingredient to be tested per state is 
less than 1.5 gram. Testing will be conducted from April 1, 1995 to 
December 15, 1995, at research stations or seed production fields in 
the following states: Alabama, Arizona, Arkansas, California, Georgia, 
Louisiana, Mississippi, Missouri, North Carolina, South Carolina, 
Tennessee, and Texas.
    A breeding nursery trial will be conducted to: (1) Evaluate and 
compare the efficacy of transgenic strains in control of lepidopteran 
target pests; (2) evaluate and select for agronomic performance of 
prospective strains for commercialization, and (3) evaluate production 
of purity blocks to minimize variability of seed within potential 
strains for commercialization. Strain trials will be conducted to 
compare advanced Bacillus thuringiensis cotton [[Page 11095]] strains 
to common commercial varieties for agronomic characteristics and fiber 
quality. There will be a maximum of 0.5 to 1 acre of transgenic 
planting per site. Research trials will be performed to: (1) Evaluate 
B.t. trait performance against target pests; (2) formulate plans for 
resistance management in B.t. cotton, and (3) provide recommendations 
for integrated pest management utilizing B.t. cotton. There will be a 
maximum of 0.5 to 2 acres of transgenic planting per site. Seed 
multiplication trials will be conducted for the purposes of ensuring 
seed purity for further research and development. There will be a 
maximum of 15 acres of transgenic planting per site.
    Containment procedures will be employed to minimize dissemination 
via pollen transfer or seed dispersal. A non-transgenic border will be 
planted and maintained should cotton be present within 1,320 feet of 
the transgenic trial. Upon completion of the tests, all plants 
(transgenic, non-transgenic control lines, and non-transgenic buffer) 
will be destroyed via bush-hog, or shred and disk. Unused seed will be 
destroyed by incineration, autoclaving, plowed under, or returned to 
the designated seed company. Monitoring will occur through the next 
growing season. The occurrence of subsequent cotton volunteers will be 
destroyed by soil incorporation or herbicide application. Transgenic 
seed will be stored in marked bags. Equipment will be thoroughly 
cleaned before and after field trials.
    The labeling proposed by Calgene, Inc. that would govern the 
conduct of the experiment states:

    This package contains insect resistant cottonseed expressing a 
Bacillus thuringiensis subsp. kurstaki (B.t.k.) protein. B.t.k. 
protein is effective in controlling certain lepidopteran insects. 
For use only at an application site of a cooperator and in 
accordance with the terms and conditions of the Experimental Use 
Permit. This labeling must be in the possession of the user at the 
time of planting. Not for sale to any person other than a 
participant or cooperator of the EPA approved Experimental Use 
Permit Program. The contents may only be used according to the 
approved EUP program. Cooperators must have at least one copy of 
each applicable protocol prior to initiating any research with the 
contents.

    Following the review of the Calgene, Inc. application and any 
comments received in response to this notice, EPA will decide whether 
to issue or deny the EUP request for this EUP program, and if issued, 
the conditions under which it is to be conducted. Any issuance of an 
EUP will be announced in the Federal Register.

List of Subjects

    Environmental protection.
    Dated: February 16, 1995.
Janet L. Andersen,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.

[FR Doc. 95-4757 Filed 2-28-95; 8:45 am]
BILLING CODE 6560-50-F