[Federal Register Volume 63, Number 151 (Thursday, August 6, 1998)]
[Notices]
[Pages 42030-42031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21036]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-30377B; FRL-6016-3]
Novartis Seeds; Approval of a Pesticide Product Amended
Registration
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces Agency approval of an application
submitted by Novartis Seeds Incorporation to conditionally amend the
plant pesticide product involving a changed use pattern of the product
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 (7511C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: Rm. 14, 9th
floor, CM #2, 1921 Jefferson Davis Highway, 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 Federal
Register-Environmental Documents entry for this document under ``Laws
and Regulations'' (http://www.epa.gov/fedrgstr/).
[[Page 42031]]
EPA issued a notice, published in the Federal Register of January
13, 1995 (60 FR 3209) (FRL-4928-9), which announced that Ciba-Geigy
Corporation (Ciba-Seeds), 3054 Cornwallis Road, P.O. Box 12257,
Research Triangle Park, NC, 27709, (now Novartis Seeds), had submitted
an application to register the transgenic plant pesticide B.t.k.
CryIA(b) Insect Control Protein as Produced in Corn (EPA File Symbol
66736-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 an active ingredient not included in any previously
registered product.
The application was approved on August 9, 1995, and was published
in the Federal Register of February 14, 1996 (61 FR 5768) (FRL-4980-5),
involving a changed use pattern, to include in its presently registered
use, a new use for full commercial use in field corn (EPA Registration
Number 66736-1). The registration was conditionally amended to allow
additional use of the product for food and feed in field corn in
accordance with FIFRA section 3(c)(7)(B).
On March 17, 1998 the amendment of this registration was approved
as ``Bacillus Thuringiensis European Corn Borer Control Protein'' to
include popcorn, containing the active ingredient Bacillus
thuringiensis CryIA(b) delta-endotoxin and the genetic material
necessary for its production (pCIB4431 in corn) involving a changed use
pattern. This use is conditional and requires insect resistance data
management, USDA NC-205 guidelines for refuge must be followed for
popcorn, and monitoring for resistance management 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 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 CryIA(b)
delta-endotoxin and the genetic material necessary for its production
(pCIB4431 in corn), 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
CryIA(b) delta-endotoxin and the genetic material necessary for its
production (pCIB4431 in corn) 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).
If the conditions are not complied with the registration will be
subject to cancellation in accordance with FIFRA section 6(e). The
registration will automatically expire on midnight April 1, 2001.
More detailed information on the conditional registration is
contained in an EPA Pesticide Fact Sheet on Bacillus thuringiensis
CryIA(b) delta-endotoxin and the genetic material necessary for its
production (pCIB4431 in corn).
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, 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 (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: July 28, 1998.
Janet L. Andersen,
Director, Biopesticides Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. 98-21036 Filed 8-5-98; 8:45 am]
BILLING CODE 6560-50-F
