[Federal Register Volume 63, Number 227 (Wednesday, November 25, 1998)]
[Notices]
[Pages 65203-65204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31547]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-30448A; FRL-6038-7]


Ecogen, Inc.; Approval of a Pesticide Product Registration

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces Agency approval of an application to 
conditionally register the pesticide product BTI Technical Powder 
Bioinsecticide containing a new active ingredient not included in any 
previously registered product pursuant to the provisions of section 
3(c)(7)(C) of the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA), as amended.

FOR FURTHER INFORMATION CONTACT: By mail: Alan Reynolds, Regulatory 
Action Leader, Biopesticides and Pollution Prevention Division (7511C), 
Office of Pesticide Programs, 401 M St., SW., Washington, DC 20460. 
Office location and telephone number: Rm. 9th floor,

[[Page 65204]]

Crystal Mall #2, Environmental Protection Agency, 1921 Jefferson Davis 
Hwy, Arlington, VA 22202, 703-605-0515; e-mail: 
[email protected].

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 Sub-Set entry for this document under ``Laws and 
Regulations'' (http://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