[Federal Register: August 6, 1998 (Volume 63, Number 151)] [Notices] [Page 42030-42031] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr06au98-56] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [OPP-30377B; FRL-6016-3] Novartis Seeds; Approval of a Pesticide Product Amended Registration AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces Agency approval of an application submitted by Novartis Seeds Incorporation to conditionally amend the plant pesticide product involving a changed use pattern of the product 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 (7511C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Rm. 14, 9th floor, CM #2, 1921 Jefferson Davis Highway, Arlington, VA 22202, (703) 308-8715; e-mail: mendelsohn.mike@epamail.epa.gov. SUPPLEMENTARY INFORMATION: Electronic Availability: Electronic copies of this document and the Fact Sheet are available from the EPA home page at the Federal Register-Environmental Documents entry for this document under ``Laws and Regulations'' (http://www.epa.gov/fedrgstr/). [[Page 42031]] EPA issued a notice, published in the Federal Register of January 13, 1995 (60 FR 3209) (FRL-4928-9), which announced that Ciba-Geigy Corporation (Ciba-Seeds), 3054 Cornwallis Road, P.O. Box 12257, Research Triangle Park, NC, 27709, (now Novartis Seeds), had submitted an application to register the transgenic plant pesticide B.t.k. CryIA(b) Insect Control Protein as Produced in Corn (EPA File Symbol 66736-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 an active ingredient not included in any previously registered product. The application was approved on August 9, 1995, and was published in the Federal Register of February 14, 1996 (61 FR 5768) (FRL-4980-5), involving a changed use pattern, to include in its presently registered use, a new use for full commercial use in field corn (EPA Registration Number 66736-1). The registration was conditionally amended to allow additional use of the product for food and feed in field corn in accordance with FIFRA section 3(c)(7)(B). On March 17, 1998 the amendment of this registration was approved as ``Bacillus Thuringiensis European Corn Borer Control Protein'' to include popcorn, containing the active ingredient Bacillus thuringiensis CryIA(b) delta-endotoxin and the genetic material necessary for its production (pCIB4431 in corn) involving a changed use pattern. This use is conditional and requires insect resistance data management, USDA NC-205 guidelines for refuge must be followed for popcorn, and monitoring for resistance management of the registration. 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 CryIA(b) delta-endotoxin and the genetic material necessary for its production (pCIB4431 in corn), 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 CryIA(b) delta-endotoxin and the genetic material necessary for its production (pCIB4431 in corn) 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). If the conditions are not complied with the registration will be subject to cancellation in accordance with FIFRA section 6(e). The registration will automatically expire on midnight April 1, 2001. More detailed information on the conditional registration is contained in an EPA Pesticide Fact Sheet on Bacillus thuringiensis CryIA(b) delta-endotoxin and the genetic material necessary for its production (pCIB4431 in corn). 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, the list of data references, 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 Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, Rm. 119, 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, DC 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: July 28, 1998. Janet L. Andersen, Director, Biopesticides Pollution Prevention Division, Office of Pesticide Programs. [FR Doc. 98-21036 Filed 8-5-98; 8:45 am] BILLING CODE 6560-50-F