[Federal Register Volume 60, Number 90 (Wednesday, May 10, 1995)]
[Notices]
[Pages 24851-24852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-11500]



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ENVIRONMENTAL PROTECTION AGENCY
[OPP-50806A; FRL-4952-8]


Issuance of an Experimental Use Permit for a Transgenic Plant 
Pesticide

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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Summary: On April 13, 1995, EPA issued EPA Experimental Use Permit 
(EUP) to Calgene Inc. to conduct field testing of a transgenic plant 
pesticide. EPA has determined that this permit may be of regional and 
national significance. The Agency evaluated the data submitted by 
Calgene and, based on these data and other available data, could 
foresee no significant risk to humans or to nontarget organisms from 
this group of field tests as proposed by Calgene. In accordance with 40 
CFR 172.11(a), the Agency is soliciting public comments.

DATES: Written comments must be received on or before June 9, 1995.

ADDRESSES: Written comments, in triplicate should bear the docket 
control number OPP-50806A 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.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect in 5.1 file format or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket number ``OPP-50806A'' No Confidential Business Information 
(CBI) should be submitted through e-mail. Electronic comments on this 
document may be filed online at many Federal Depository Libraries. 
Additional information on electronic submissions can be found in unit 
III of this document.
    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: Linda A. Hollis, 
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 (703-308-8733).

SUPPLEMENTARY INFORMATION:

I. EUP Program

    The EUP was issued to Calgene Inc., 1920 5th St., Davis, CA 95616. 
The permit was assigned EUP number 65247-EUP-1 and issued for 1 year, 
beginning April 13, 1995 and ending April 15, 1996. Calgene will be 
testing 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.
    A total of 2,460 pounds of transgenic cottonseed will be planted on 
2.0 to 27.0 acre sites for a total of 67 acres transgenic planting. 
Calgene's test sites are located in the following States: Alabama, 
Arizona, Arkansas, Georgia, Louisiana, Mississippi, Missouri, North 
Carolina, South Carolina, Tennessee and Texas. Upon completion of data 
collection and/or harvest, all cotton plants in the transgenic trial 
will be destroyed by incorporation into the soil. Seed harvested from 
the plant breeding nursery and strains test may be retained for use in 
further research and [[Page 24852]] development and used as future 
planting seed. No seed may be used for food or feed, and all other 
plant material must be destroyed.
    Calgene's EUP program will include the following three experiments 
designed to evaluate the performance of the expressed proteins against 
lepidopteran pests: Strains Tests; Breeding Nurseries, and Research 
Tests.
    EPA's scientific staff has evaluated the potential for adverse 
effects on nontarget species and the environment as a result of this 
EUP. The Agency does not foresee any human health risks or effects 
resulting from the proposed field tests because there will be minimal 
human exposure.
    Further, EPA foresees no significant environmental impact resulting 
from the testing under this EUP because it is of limited acreage and 
duration and because minimal offsite movement (approximately three 
percent or less) of expressed proteins is expected to occur. Yet a 
potential exists for offspring of commercially grown cotton to become 
feral (wild), and these wild offspring might have a selective advantage 
due to the addition of these insect resistance traits in their genetic 
make-up; however, feral cotton has many additional constraints, such as 
hardiness, habit, and reproductive limits, which have prevented it from 
becoming aggressive or weedy despite cotton's long cultivation in the 
continental United States. Hence, the expression of B.t.k. protein or 
NPT II marker enzyme genes is expected to neither create nor aggravate 
any weedy or aggressive characteristics in cotton grown for this EUP.
    Because the field tests will be conducted in areas of the 11 States 
where no known populations of endangered lepidopteran species exist, no 
risk is expected as a result of the proposed field tests. In addition, 
because of the low exposure due to the limited acreage and duration of 
the EUP, EPA feels that there will not be a situation warranting a 
formal review under the Endangered Species Act for any endangered 
mammals, birds, invertebrates, plants or aquatic species.

II. Labeling

    The labeling states the following:

    This package contains insect resistant cottonseed expressing a 
Bacillus thuringiensis subsp. kurstaki (B.t.k.) protein 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.

III. Public Comments

     A record has been established for this document under docket 
number ``OPP-50806A'' (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The public record is located in Rm. 1132 of the Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.

    Electronic comments can be sent directly to EPA at:

    [email protected]

    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.

    The official record for this document, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer all comments received electronically into printed, 
paper form as they are received and will place the paper copies in the 
official record which will also include all comments submitted directly 
in writing. The official record is the paper record maintained at the 
address in ``ADDRESSES'' at the beginning of this document.

    The Agency announced receipt of Calgene's application in the 
Federal Register of March 1, 1995 (60 FR 11904). A 30-day public 
comment period was provided. No comments were received.

    Dated: April 28, 1995.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

[FR Doc. 95-11500 Filed 5-9-95; 8:45 am]

BILLING CODE 6560-50-F