[Federal Register Volume 59, Number 36 (Wednesday, February 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4050]


[[Page Unknown]]

[Federal Register: February 23, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
[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.

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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) 
-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 -
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) -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) 
-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 -
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) -
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]
BILLING CODE 6560-50-F