[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: [email protected].

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