Ecogen, Inc.; Approval of a Pesticide Product Registration

Electronic Availability: Electronic copies of this document and the Fact Sheet are available from the EPA home page at the Federal Register Environmental Sub-Set entry for this document under ``Laws and Regulations'' (www.epa.gov/fedrgstr/). EPA issued a notice, published the Federal Register of February 25, 1998 (63 FR 9517)(FRL-5773-7), which announced that Ecogen Inc., 2005 Cabot Blvd., West, P.O. Box 3023 Langhorne, PA 19047-3023, had submitted an application to conditionally register the pesticide product BTI Technical Powder Bioinsecticide (EPA File Symbol 55638-UR) containing the active ingredient Bacillus thuringiensis subspecies israelensis strain EG2215 at 20%, an active ingredient not included in any previously registered pesticide product. The application was approved on September 30, 1998, as BTI Techncial Powder Bioinsecticide, a manufacturing use product for formulation into end-use products to control mosquitoes (EPA Registration Number 55638-41). A conditional registration may be granted under section 3(c)(7)(C) of FIFRA for a new active ingredient where certain data are lacking, on condition that such data are received by the end of the conditional registration period and do not meet or exceed the risk criteria set forth in 40 CFR 154.7; that use of the pesticide during the conditional registration period will not cause unreasonable adverse effects; and that use of the pesticide is in the public interest. The Agency has considered the available data on the risks associated with the proposed use of Bacillus thuringiensis subspecies israelensis strain EG2215, and information on social, economic, and environmental benefits to be derived from such use. Specifically, the Agency has considered the nature and its pattern of use, application methods and rates, and level and extent of potential exposure. Based on these reviews, the Agency was able to make basic health and safety determinations which show that use of Bacillus thuringiensis subspecies israelensis strain EG2215 during the period of conditional registration will not cause any unreasonable adverse effect on the environment, and that use of the pesticide is, in the public interest. Consistent with section 3(c)(7)(C), the Agency has determined that this conditional registration is in the public interest. Use of the pesticides are of significance to the user community, and appropriate labeling, use directions, and other measures have been taken to ensure that use of the pesticides will not result in unreasonable adverse effects to man and the environment. The studies listed below must be completed within 6 months of the date of the conditional registration: 1. A Daphnia Study. 2. An Interperitoneal Injection Study. 3. Mosquito Bioassay to Verify the Potency of the Toxin. 4. An Eye/Dermal Irritattion Study. This product is conditionally registered in accordance with FIFRA section 3(c)(7)(C). If these conditions are not complied with, the registration will be cancelled in accordance with FIFRA section 6(e). More detailed information on this conditional registration is contained in an EPA Pesticide Fact Sheet on Bacillus thuringiensis subspecies israelensis strain EG2215. A paper 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 Intregrity 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: October 20, 1998.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.

[FR Doc. 98-31547 Filed 11-24-98; 8:45 am] BILLING CODE 6560-50-F