[Federal Register Volume 61, Number 31 (Wednesday, February 14, 1996)]
[Notices]
[Pages 5768-5769]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2726]



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ENVIRONMENTAL PROTECTION AGENCY
[OPP-30377A; FRL-4980-5]


Certain Companies; Approval of Pesticide Product Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces Agency approval of applications 
submitted by Ciba-Geigy Corporation (Ciba Seeds) and Mycogen Plant 
Sciences, to conditionally amend two transgenic plant pesticide 
products involving a changed use pattern of the products pursuant to 
the provisions of section 3(c)(7)(B) of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA), as amended.

FOR FURTHER INFORMATION CONTACT: By mail: Michael Mendelsohn, 
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: Rm. CS51B6, 
Westfield Building North Tower, 2800 Crystal Drive, Arlington, VA 
22202, (703) 308-8715; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the 
Federal Register of January 13, 1995 (60 FR 3209), which announced that 
Ciba-Geigy Corporation (Ciba-Seeds), 3054 Cornwallis Road, P.O. Box 
12257, Research Triangle Park, NC, 27709, and Mycogen Plant Sciences, 
4980 Carroll Canyon Road, San Diego, CA 92121, had submitted 
applications to register the transgenic plant pesticides B.t.k. 
CryIA(b) Insect Control Protein as Produced in Corn and B.t.k. CryIA(b) 
Insect Control Protein as Produced in Corn (EPA File Symbols 66736-R 
and 68467-R), containing the active ingredient Bacillus thuringiensis 
delta-endotoxin as produced in corn by a cryIA(b) gene and its 
controlling sequences as found on plasmid vector pCIB4431 0.0001-0.0018 
percent total plant protein respectively, an active ingredient not 
included in any previously registered products.
    Both applications were approved on August 9, 1995 to include in 
their presently registered uses a new use for full commercial use in 
field corn (EPA Registration Numbers 66736-1 and 68467-1).
    These registrations were conditionally amended to allow additional 
use of the products for food and feed in field corn in accordance with 
FIFRA section 3(c)(7)(B). This use is conditional upon data development 
in the area of resistance management research and limited by resistance 
management and expiration provisions of the registrations.
    A conditional registration may be granted under section 3(c)(7)(B) 
of FIFRA for a product involving a changed use pattern where certain 
data are lacking, on condition that such data are received as specified 
by EPA and the applicant has submitted satsifactory data pertaining to 
the proposed additional use and the amended registration would not 
significantly increase the risk of any unreasonable adverse effect.
    The Agency has considered the available data on the risks 
associated with the proposed use of Bacillus thuringiensis delta-
endotoxin as produced in corn by a cryIA(b) gene and its controlling 
sequences as found on 

[[Page 5769]]
plasmid vector pCIB4431, and information on social, economic, and 
environmental benefits to be derived from such use. Based on these 
reviews, the Agency was able to make basic environmental, health, and 
safety determinations which show that use of Bacillus thuringiensis 
delta-endotoxin as produced in corn by a cryIA(b) gene and its 
controlling sequences as found on plasmid vector pCIB4431 consistent 
with the terms and conditions of registration during the period of 
conditional registration will not significantly increase the risk of 
unreasonable adverse effect on the environment.
    These products are conditionally registered in accordance with 
FIFRA section 3(c)(7)(B). Submission of production information for 
these products for the fiscal year in which use of commercial field 
corn is conditionally registered, begins on October 1, and ends 
September 30. Production information will be submitted to the Agency no 
later than November 15, following the end of the preceding fiscal year. 
If the conditions are not complied with the registrations will be 
subject to cancellation in accordance with FIFRA section 6(e). These 
registrations will automatically expire on midnight August 2, 2000.
    More detailed information on these conditional registrations is 
contained in an EPA Pesticide Fact Sheet on Bacillus thuringiensis 
delta-endotoxin as produced in corn by a cryIA(b) gene and its 
controlling sequences as found on plasmid vector pCIB4431.
    A copy of this fact sheet, which provides a summary description of 
the chemical, use patterns and formulations, science findings, and the 
Agency's regulatory position and rationale, may be obtained from the 
National Technical Information Service (NTIS), 5285 Port Royal Road, 
Springfield, VA 22161.
    In accordance with section 3(c)(2) of FIFRA, a copy of the approved 
label and the list of data references used to support registration are 
available for public inspection in the office of the Product Manager. 
The data and other scientific information used to support registration, 
except for material specifically protected by section 10 of FIFRA, are 
available for public inspection in the Public Response and Program 
Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, Rm. 1132, CM #2, 
Arlington, VA 22202 (703-305-5805). Requests for data must be made in 
accordance with the provisions of the Freedom of Information Act and 
must be addressed to the Freedom of Information Office (A-101), 401 M 
St., SW., Washington, D.C. 20460. Such requests should: (1) Identify 
the product name and registration number and (2) specify the data or 
information desired.

    Authority: 7 U.S.C. 136.

List of Subjects

    Environmental protection, Pesticides and pests, Product 
registration.

    Dated: January 31, 1996.

Janet L. Andersen,
Acting Director, Biopesticides Pollution Prevention Division, Office of 
Pesticide Programs.

[FR Doc. 96-2726 Filed 2-13-96; 8:45 am]
BILLING CODE 6560-50-F