Ecogen, Inc.; Approval of a Pesticide Product Registration
[Federal Register: November 25, 1998 (Volume 63, Number 227)]
[Notices]
[Page 65203-65204]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25no98-102]
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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:
reynolds.alan@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 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
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