[Federal Register Volume 62, Number 154 (Monday, August 11, 1997)]
[Notices]
[Pages 42979-42980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21146]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-30407B; FRL-5730-1]


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 to 
conditionally register the pesticide product CryIA(b) Form of the 
B.t.k. Insect Control Protein, containing a new active ingredient not 
included in any previously registered product pursuant to the 
provisions of section 3(c)(7)(C) 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, 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: 
[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 April 17, 
1996 (61 FR 16781; FRL-5362-2), which announced that Monsanto Company, 
700 Chesterfield Parkway North, St. Louis, MO 63198, had submitted an 
application to register the pesticide product CryIA(b) Form of the 
Bacillus thuringiensis subsp. kurstaki Insect Control Protein (EPA File 
Symbol 524-UOE), containing the new active ingredient Bacillus 
thuringiensis delta-endotoxin as produced in corn by a CryIA(b) gene 
and its controlling

[[Page 42980]]

sequences, an active ingredient not included in any previously 
registered product. 
    The application was approved on May 29, 1996, as CryIA(b) Form of 
the B.t.k. Insect Control Protein for seed propagation (EPA 
Registration Number 524-492). The chemical was amended to read 
``Bacillus thuringiensis delta-endotoxin as produced by the CryIA(b) 
gene and the genetic material necessary for its production (PV-ZMCT01) 
in corn.''
    A conditional registration may be granted under section 3(c)(7)(C) 
of FIFRA for a new active ingredient where certain data are lacking, on 
condition that such data are received by the end of the conditional 
registration period and do not meet or exceed the risk criteria set 
forth in 40 CFR 154.7; that use of the pesticide during the conditional 
registration period will not cause unreasonable adverse effects; and 
that use of the pesticide is in the public interest.
    The Agency has considered the available data on the risks 
associated with the proposed use of Bacillus thuringiensis delta-
endotoxin as produced by the CryIA(b) gene and the genetic material 
necessary for its production (PV-ZMCT01) in corn, and information on 
social, economic, and environmental benefits to be derived from such 
use. Specifically, the Agency has considered the nature and its pattern 
of use, application methods and rates, and level and extent of 
potential exposure. Based on these reviews, the Agency was able to make 
basic health and safety determinations which show that use of Bacillus 
thuringiensis delta-endotoxin as produced by the CryIA(b) gene and the 
genetic material necessary for its production (PV-ZMCT01) in corn 
during the period of conditional registration will not cause any 
unreasonable adverse effect on the environment, and that use of the 
pesticide is in the public interest.
    This product is conditionally registered in accordance with FIFRA 
section 3(c)(7)(C). If the conditions are not complied with the 
registration will be subject to cancellation in accordance with FIFRA 
section 6(e).
    Consistent with section 3(c)(7)(C), the Agency has determined that 
this conditional registration is in the public interest. Use of the 
pesticides are of significance to the user community, and appropriate 
labeling, use directions, and other measures have been taken to ensure 
that use of the pesticides will not result in unreasonable adverse 
effects to man and the environment.
    More detailed information on this 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 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.

    Dated: July 30, 1997.

Janet L. Andersen,

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

[FR Doc. 97-21146 Filed 8-8-97; 8:45 am]
BILLING CODE 6560-50-F