Receipt of an Application for Pesticide Registration for a Transgenic Plant Pesticide

ENVIRONMENTAL PROTECTION AGENCY

[OPP-30373; FRL-4913-5]

Receipt of an Application for Pesticide Registration for a

Transgenic Plant Pesticide

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has received an application from Monsanto Company for a

transgenic plant pesticide for conditional registration containing the

new active ingredient Bacillus thuringiensis var. kurstaki delta

endotoxin protein as produced by the Cry1A(c) gene and it controlling

sequences. The EPA File Symbol for this application is 524-UTI, and the

associated tolerance petition number is PP 4F 4331. This is the second

application for registration of a transgenic plant pesticide under

section 3(c)(4) of the Federal Insecticide, Fungicide, and Rodenticide

Act (FIFRA), as amended, in which a plant has been genetically altered

to produce a pesticide. Because of its uniqueness 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 submitted by October 31, 1994.

ADDRESSES: By mail submit comments identified by the document control

number [OPP-30373] and the (File Symbol 524-UTI) to: Public Response

and Program Resources Branch, Field Operations Division (7506C),

Registration Division (7505C), Office of Pesticide Programs,

Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.

In person, bring comments to: Rm. 1132, Environmental Protection

Agency, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.

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. 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, except legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Phil 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, CM #2, 1921 Jefferson

Davis Hwy, Arlington, VA 22202, (703-305-7690).

SUPPLEMENTARY INFORMATION: On February 11, 1994, an application to

conditionally register a transgenic plant pesticide Bacillus

thuringiensis var. kurstaki (B.t.k.) Insect Control Protein (CrylA(c)),

containing the new active ingredient Bacillus thuringiensis var.

kurstaki delta endotoxin protein as produced by the Cry1A(c) gene and

it controlling sequences at 100 percent was received from Monsanto

Company, 700 Chesterfield Village Parkway, St. Louis, MO 63198. The

application was assigned EPA File Symbol 524-UTI.

Through the genetic modification of cotton, Monsanto has developed

an environmentally compatible alternative for controlling many of the

lepidopteran caterpillars which feed on this crop. This Insect

Resistant Cotton (IRC) cotton produces the insect control protein

derived from the common soil bacterium Bacillus thuringiensis var.

kurstaki (B.t.k.). The protein produced is nearly identical in

structure and activity to that found in nature and in commercial B.t.k

formulations, registered by EPA.

The commericialization and use of IRC offers several significant

benefits to the grower, the public, and environment. Results from field

experiments conducted in the past 4 years throughout the cotton growing

regions have demonstrated that IRC is protected season long from the

major lepidopteran pests which feed on the foliage and bolls of the

cotton plant, while nontarget organisms, including beneficial insects,

mammals, and birds are unaffected. Growers planting IRC may not require

additional insecticide applications to control these pests. Such a

substantial reduction in insecticide use will enhance biological

control and the implementation of other pest management strategies for

other cotton insect pests. The purpose of Monsanto's application for

pesticide registration and exemption from the requirement of a

tolerance, is to acquire a registration so that commercialization of

their innovative product can be available for commercial use in control

of the pest, the lepidopteran caterpillars on cotton.

Notice of approval or denial of an application to register a

pesticide product will be announced in the Federal Register. The

procedure for requesting data will be given in the Federal Register if

an application is approved.

Comments received within the specified time period will be

considered before a final decision is made; comments received after the

time specified will be considered only to the extent possible without

delaying processing of the application.

Written comments filed pursuant to this notice, will be available

in the Public Response and Program Resources Branch, Field Operations

Division (FOD) office at the address provided from 8 a.m. to 4 p.m.,

Monday through Friday, except legal holidays. It is suggested that

persons interested in reviewing the application file, telephone the FOD

office (703-305-5805), to ensure that the file is available on the date

of intended visit.

Authority: 7 U.S.C. 136.

List of Subjects

Environmental protection, Pesticides and pests, Product

registration.

Dated: September 22, 1994.

Stephen L. Johnson,

Director, Registration Division, Office of Pesticide Programs.

[FR Doc. 94-24129 Filed 9-28-94; 8:45 am]

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