[Federal Register Volume 62, Number 175 (Wednesday, September 10, 1997)]
[Notices]
[Pages 47664-47665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23686]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-30394A; FRL-5726-6]


Monsanto Company; 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 
submitted by Monsanto Company to conditionally register the product 
YieldGard for a changed use pattern 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, 
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: 
[email protected].

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 Monsanto 
Company 700 Chesterfield Parkway North St. Louis, MO 63198, had 
submitted an application to register the product Bacillus thuringiensis 
subsp. kurstaki (B.t.k.) Insect Control Protein (EPA File Symbol 524-
UIO).
    The product was announced as containing 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.  
Subsequent to this, the Agency approved a seed increase registration 
for this active ingredient on May 28, 1996, under EPA Registration No. 
524-492.
    The full commercial use application from Monsanto was approved on 
December 20, 1996, as YieldGard (formerly Bacillus thuringiensis subsp. 
kurstaki (B.t.k.) Insect Control Protein) for use on field corn (EPA 
Registration Number 524-489), the chemical was amended to read 
``Bacillus thuringiensis CryIA(b) delta endotoxin and the genetic 
material necessary for its production in corn at 0.023-0.029 percent.''
    This registration was conditionally granted 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 certain 
data are lacking, on condition that such data are received as specified 
by EPA and the applicant has submitted satisfactory 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 
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 health and safety determinations which 
show that use of Bacillus thuringiensis CryIA(b) delta endotoxin and 
the genetic material necessary for its production in corn consistent 
with the terms and conditions of registration during the period of 
conditional registration will not cause any unreasonable adverse effect 
on the environment.
    This product is conditionally registered in accordance with FIFRA 
section 3(c)(7)(B). This registration will automatically expire on 
midnight April 1, 2001. EPA will reevaluate the effectiveness of 
Monsanto's resistance management plan before April 1, 2001, and decide 
whether to convert the registrations to a non-expiring registrations. 
If the conditions are not complied with the registration will be 
subject to cancellation in accordance with FIFRA section 6(e).
    More detailed information on this conditional registration is 
contained in an EPA Pesticide Fact Sheet on Monsanto's Bacillus 
thuringiensis CryIA(b) delta-endotoxin and the genetic material 
necessary for its production in corn.
    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 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.


[[Page 47665]]


    Dated: August 26, 1997.

Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

[FR Doc. 97-23686 Filed 9-9-97; 8:45 am]
BILLING CODE 6560-50-F