[Federal Register Volume 62, Number 175 (Wednesday, September 10, 1997)]
[Notices]
[Pages 47665-47666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23688]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-30394B; FRL-5740-4]


Novartis Seeds; 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 Northrup King Insect Resistant Corn 
containing a new 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 and the subsequent amendment of this product for a 
changed use pattern pursuant to section 3(c)(7)(B) 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 November 
1, 1995 (60 FR 55574; FRL-4979-7), which announced that Northrup King 
Company, 7500 Olson Memorial Highway, Golden Valley, MN 55427, 
submitted an application to register the transgenic plant pesticide 
product Northrup King Insect Resistant Corn (EPA File Symbol 67979-R). 
The Northrup King Co., has changed and is now known as Novartis Seeds, 
P.O. Box 12257, Research Triangle Park, NC 27709-2257. This product 
contained the plant pesticide active ingredient Bacillus thuringiensis 
subsp. kurstaki delta-endotoxin as produced in corn by a CryIA(b) gene 
and its controlling sequences, an active ingredient not included in any 
previously registered product. 
    The application from Northrup King (now known as Novartis Seeds) 
was approved on May 14, 1996, as Northrup King Insect Resistant Corn 
for seed propagation only (EPA Registration Number 67979-1) the 
chemical was amended to read ``Bacillus thuringiensis delta endotoxin 
as produced by a CryIA(b) gene and its controlling sequences as found 
on plasmid vector pZO1502 at 0.00475-0.0006 percent.''
    A conditional registration may be granted under section 3(c)(7)(C) 
of FIFRA for new active ingredients 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 delta 
endotoxin as produced by a CryIA(b) gene and its controlling sequences 
as found on plasmid vector pZO1502, 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 delta endotoxin as produced by a CryIA(b) gene and its 
controlling sequences as found on plasmid vector pZO1502 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 was conditionally registered in accordance with FIFRA 
section 3(c)(7)(C). The registration was originally to expire in May 
1997. However, as outlined further in this document, this product was 
amended pursuant to section 3(c)(7)(B) of FIFRA to allow commercial use 
and thus, the expiration date was extended to April 1, 2001. EPA will 
reevaluate the effectiveness of Novartis Seeds resistance management 
plan before April 1, 2001, and decide whether to convert the 
registration to a non-expiring registration. If the conditions are not 
complied with the registration will be subject to cancellation in 
accordance with FIFRA section 6(e).
    Consistent with section 3(c)(7)(C), the Agency has determined that 
this conditional registration was in the public interest. Use of the 
pesticide is 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 product was amended on August 5, 1996 to include in the already 
registered uses a new use for commercial use in field corn.
    This registration was conditionally amended to allow additional use 
of the active ingredient for food and feed in field corn in accordance 
with FIFRA section 3(c)(7)(B). This use is conditional upon data 
development in the area resistance management research and Collembola 
and Daphnia magna toxicity testing and limited by resistance management 
and expiration provisions 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 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.
    More detailed information on this conditional registration is 
contained in an EPA Pesticide Fact Sheet on Bacillus thuringiensis 
delta endotoxin as produced by a CryIA(b) gene and its controlling 
sequences as found on plasmid vector pZO1502.
    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

[[Page 47666]]

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 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. 97-23688 Filed 9-9-97; 8:45 am]
BILLING CODE 6560-50-F