[Federal Register Volume 59, Number 188 (Thursday, September 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-24129]


[[Page Unknown]]

[Federal Register: September 29, 1994]


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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]
BILLING CODE 6560-50-F