Certain Companies; Approval of Pesticide Product Registrations

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

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