[Federal Register Volume 61, Number 31 (Wednesday, February 14, 1996)]
[Notices]
[Pages 5768-5769]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2726]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-30377A; FRL-4980-5]
Certain Companies; Approval of Pesticide Product Registrations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces Agency approval of applications
submitted by Ciba-Geigy Corporation (Ciba Seeds) and Mycogen Plant
Sciences, to conditionally amend two transgenic plant pesticide
products involving a changed use pattern of the products pursuant to
the provisions of section 3(c)(7)(B) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended.
FOR FURTHER INFORMATION CONTACT: By mail: Michael Mendelsohn,
Biopesticides and Pollution Prevention Division (7501W), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: Rm. CS51B6,
Westfield Building North Tower, 2800 Crystal Drive, Arlington, VA
22202, (703) 308-8715; e-mail: mendelsohn.mike@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of January 13, 1995 (60 FR 3209), which announced that
Ciba-Geigy Corporation (Ciba-Seeds), 3054 Cornwallis Road, P.O. Box
12257, Research Triangle Park, NC, 27709, and Mycogen Plant Sciences,
4980 Carroll Canyon Road, San Diego, CA 92121, had submitted
applications to register the transgenic plant pesticides B.t.k.
CryIA(b) Insect Control Protein as Produced in Corn and B.t.k. CryIA(b)
Insect Control Protein as Produced in Corn (EPA File Symbols 66736-R
and 68467-R), containing the active ingredient Bacillus thuringiensis
delta-endotoxin as produced in corn by a cryIA(b) gene and its
controlling sequences as found on plasmid vector pCIB4431 0.0001-0.0018
percent total plant protein respectively, an active ingredient not
included in any previously registered products.
Both applications were approved on August 9, 1995 to include in
their presently registered uses a new use for full commercial use in
field corn (EPA Registration Numbers 66736-1 and 68467-1).
These registrations were conditionally amended to allow additional
use of the products 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 of resistance management research and limited by resistance
management and expiration provisions of the registrations.
A conditional registration may be granted under section 3(c)(7)(B)
of FIFRA for a product involving a changed use pattern where certain
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.
The Agency has considered the available data on the risks
associated with the proposed use of Bacillus thuringiensis delta-
endotoxin as produced in corn by a cryIA(b) gene and its controlling
sequences as found on
[[Page 5769]]
plasmid vector pCIB4431, and information on social, economic, and
environmental benefits to be derived from such use. Based on these
reviews, the Agency was able to make basic environmental, health, and
safety determinations which show that use of Bacillus thuringiensis
delta-endotoxin as produced in corn by a cryIA(b) gene and its
controlling sequences as found on plasmid vector pCIB4431 consistent
with the terms and conditions of registration during the period of
conditional registration will not significantly increase the risk of
unreasonable adverse effect on the environment.
These products are conditionally registered in accordance with
FIFRA section 3(c)(7)(B). Submission of production information for
these products for the fiscal year in which use of commercial field
corn is conditionally registered, begins on October 1, and ends
September 30. Production information will be submitted to the Agency no
later than November 15, following the end of the preceding fiscal year.
If the conditions are not complied with the registrations will be
subject to cancellation in accordance with FIFRA section 6(e). These
registrations will automatically expire on midnight August 2, 2000.
More detailed information on these conditional registrations is
contained in an EPA Pesticide Fact Sheet on Bacillus thuringiensis
delta-endotoxin as produced in corn by a cryIA(b) gene and its
controlling sequences as found on plasmid vector pCIB4431.
A 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 and the list of data references used to support registration are
available for public inspection in the office of the Product Manager.
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 Response and Program
Resources Branch, Field Operations 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: January 31, 1996.
Janet L. Andersen,
Acting Director, Biopesticides Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. 96-2726 Filed 2-13-96; 8:45 am]
BILLING CODE 6560-50-F
