98-22013. Novartis Seeds; Approval of a Pesticide Product Registration  

  • [Federal Register Volume 63, Number 158 (Monday, August 17, 1998)]
    [Notices]
    [Pages 43935-43936]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-22013]
    
    
    -----------------------------------------------------------------------
    
    ENVIRONMENTAL PROTECTION AGENCY
    
    [OPP-30439A; FRL-6016-4]
    
    
    Novartis Seeds; Approval of a Pesticide Product Registration
    
    AGENCY: Environmental Protection Agency (EPA).
    ACTION: Notice.
    
    -----------------------------------------------------------------------
    
    SUMMARY: This notice announces Agency approval of an application 
    submitted by Novartis Seeds to conditionally register the plant 
    pesticide Attribute Insect Protected Sweet Corn 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/).
        EPA issued a notice, published in the Federal Register of September 
    10, 1997 (62 FR 47663) (FRL-5740-5), which announced that Rogers Seed 
    Company, 600 N. Armstrong Place, Boise, ID 83704, (now Novartis Seeds), 
    had submitted an application to register the plant pesticide product 
    Attribute Insect Protected Sweet Corn (EPA File Symbol 65268-R) 
    containing the active ingredient Bacillus thuringiensis CryIA(b) delta-
    endotoxin and the genetic material (plasmid vector pZO1502) necessary 
    for its production in corn at 0.0002-0.0006 percent involving a changed 
    use pattern, to include in its presently registered use on field corn, 
    a new use of the Bt. protein plant pesticide active ingredient for the 
    control of the European Corn Borer and Corn Earworm in sweet corn.
        The application was approved on February 27, 1998, as Attribute 
    Insect Protected Sweet Corn involving a changed use pattern, to include 
    in its presently registered use, a new use on sweet corn (EPA 
    Registration Number 65268-1).
        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 (plasmid vector pZO1502) 
    necessary for its production 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 
    (plasmid vector pZO1502) necessary for its production 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).
        These requirements listed below must be complied with:
        1. Sale of commercial sweet corn production only.
        2. Corn stalks must be destroyed 1-month after harvest.
        3. Insect resistance management data.
        4. Monitoring for resistance.
        5. Collembola and Daphna magna study.
        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 (plasmid vector 
    pZO1502) necessary for its production in corn.
        A copy of this fact sheet, which provides a summary description of 
    the chemical, use patterns and
    
    [[Page 43936]]
    
    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 29, 1998.
    
    Janet L. Andersen,
    
    Director, Biopesticides Pollution Prevention Division, Office of 
    Pesticide Programs.
    
    [FR Doc. 98-22013 Filed 8-14-98; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Published:
08/17/1998
Department:
Environmental Protection Agency
Entry Type:
Notice
Action:
Notice.
Document Number:
98-22013
Pages:
43935-43936 (2 pages)
Docket Numbers:
OPP-30439A, FRL-6016-4
PDF File:
98-22013.pdf