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Bacillus thuringiensis CryIA(b) Delta-Endotoxin - Experimental Use Permit 2/94

[OPP-50775; FRL-4761-2]
Receipt of an Application for an Experimental Use Permit for
a Transgenic Plant Pesticide
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
------------------------------------------------------------
SUMMARY: On October 21, 1993, EPA received an application from
Monsanto Company for an Experimental Use Permit (EUP) for a
transgenic plant pesticide. This is the fourth EUP application
under the Federal Insecticide, Fungicide, and Rodenticide Act
for testing with a pesticidal substance that is produced in
a plant. The Agency has determined that this application may
be of regional and national significance. Therefore in accordance
with 40 CFR 172.11(a), the Agency is soliciting public comments
on this application.

DATES: Written comments must be received by March 25, 1994.

ADDRESSES: Comments, in triplicate, should bear the docket control
number OPP-50775 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: Phillip O. Hutton,
Product Manager (PM) 18, Registration Division (7505C), Office
of Pesticide Programs, Environmental Protection Agency, 401
M St., SW., Washington, DC 20460. Office location and telephone
number: Rm. 213, Crystal Mall #2, 1921 Jefferson Davis Highway,
Crystal City, VA 22202, (703)305-7690.

SUPPLEMENTARY INFORMATION: On October 21, 1993, EPA received
an application for an EUP from Monsanto Company, 700 Chesterfield
Village Parkway, St. Louis, Missouri 63198. The application
was assigned EPA File Symbol 524-EUP-IE. Monsanto proposes to
test the cryIA(b) ë-endotoxin (derived from the soil microbe
Bacillus thuringiensis) as expressed in a series of corn lines
from March 1, 1994, to February 28, 1995. The amino acid sequence
of the ë-endotoxin in corn was maintained to be identical to
the amino acid sequence produced in Bacillus thuringiensis.
However, the nucleotide sequence of the cryIA(b) gene was modified
to enhance expression in corn. In addition to expressing the
cryIA(b) ë-endotoxin, the majority of the corn lines being evaluated
also express the 5-enol-pyruvylshikimate-3-phosphate (CP4, ESPS)
and/or glyphosate oxidoreductase (GOX) proteins which are used
as selectable markers and bestow glyphosate resistance. A minimal
number of the cryIA(b) ë-endotoxin expressing corn lines expressed
neomycin phosphotranferase II (NPTII) as the selectable marker.
NPTII bestows resistance to the common aminoglycoside antibiotics
kanamycin, G418, or panomomycin.
   Several small-scale field experiments have been conducted
under permits granted by the United States Department of Agriculture.
Larger scale testing is now required in order to further evaluate
the performance of the expressed protein against the European
Corn Borer in various geographical areas in which corn is commercially
produced. These experiments include: Isopopulation yield trials,
gene efficacy, ECB ecological studies, and various evaluations
of the Bt ë-endotoxin corn lines in combination with glyphosate.
In addition to experiments related to efficacy, breeding nursery
and seed increase trials are planned.
   Up to 605 acres are proposed for planting with approximately
17,274 pounds of transgenic seed. This amount of seed will contain
approximately 205 grams (dry weight) of the cryIA(b) ë-endotoxin.
The following States are included in the program: Colorado,
Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky,
Maryland, Michigan, Minnesota, Missouri, Nebraska, New York,
North Carolina, Ohio, Pennsylvania, South Dakota, Tennessee,
Texas, Virginia, and Wisconsin, and Puerto Rico.
   No temporary tolerances are being requested relative to the
proposed experimental use permit since any reserved transgenic
plant material will be used only for research or future plantings.
All other materials will be destroyed. Professionally qualified
Monsanto employees will supervise the program, which will be
carried out by public and private cooperators in addition to
professionals at Monsanto test facilities.
   Upon review of the Monsanto application, any comments received
in response to this notice and any other relevant information,
EPA will set conditions under which the experiments will be
conducted. Any issuance of an EUP will be announced in the Federal
Register.

   Dated: February 15, 1994.

Stephanie R. Irene,
Acting Director, Registration Division, Office of Pesticide
Programs.

[FR Doc. 94-4050 Filed 2-22-94; 8:45 am]