[Federal Register Volume 62, Number 175 (Wednesday, September 10, 1997)]
[Notices]
[Pages 47662-47663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23687]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-30415A; FRL-5726-7]


Dekalb Genetics Corporation; Approval of a Pesticide Product 
Conditional 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 product DEKALBt, containing a plant 
pesticide 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: Michael Mendelsohn, 
Regulatory Action Leader, Biopesticides and Pollution Prevention 
Division (7501W), Office of Pesticide Programs, 401 M St., SW., 
Washington, DC 20460. Office location and telephone number: Westfield 
Building North Tower, CS #1, Environmental Protection Agency, 2800 
Crystal Drive, Arlington, VA 22202, 703-308-8715; 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 Environmental 
Sub-Set entry for this document under ``Regulations'' (http://
www.epa.gov/fedrgstr/).
    EPA issued a notice, published in the Federal Register of July 31, 
1996 (61 FR 39959; FRL-5379-9), which announced that Dekalb Genetics 
Corporation, 3100 Sycamore Road, DeKalb, IL 60115-9600, had submitted 
an application to register the product Corn Borer-Resistant Corn 
Containing Insecticidal Bt Protein II (EPA File Symbol 69575-E), 
containing the plant pesticide active ingredient Bacillus thuringiensis 
subspecies kurstaki CryIA(c) delta-endotoxin and the genetic material 
necessary for its production in corn at 100 percent, an active 
ingredient not included in any previously registered product. 
    The application was approved on March 25, 1997, as DEKALBt 
(formerly Corn Borer-Resistant Corn Containing Insecticidal Bt Protein 
II); the corn seed containing this plant pesticide is for use on field 
corn only (EPA Registration Number 69575-2). The chemical was amended 
to read ``Bacillus thuringiensis CryIA(c) delta-endotoxin and the 
genetic material necessary for its production in corn.''
    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 CryIA(c) 
delta-endotoxin and the genetic material necessary for its production 
in corn, 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 CryIA(c) 
delta-endotoxin and the genetic material necessary for its production 
in corn 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.
    This product is conditionally registered in accordance with FIFRA 
section 3(c)(7)(C). Dekalb must submit all data required for 
registration for this product. If the conditions are not complied with 
the registration will be subject to cancellation in accordance with 
FIFRA section 6(e). This registration will automatically expire on 
April 1, 2001.
    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.
    More detailed information on this conditional registration is 
contained in an EPA Pesticide Fact Sheet on Bacillus thuringiensis 
CryIA(c) delta-endotoxin and the genetic material necessary for its 
production in corn.
    A copy of the 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 (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

[[Page 47663]]

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: August 26, 1997.

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

[FR Doc. 97-23687 Filed 9-9-97; 8:45 am]
BILLING CODE 6560-50-F