[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:
mendelsohn.mike@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 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
