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Monsanto gen eng BT corn approved by EPA today




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:
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 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 secti

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Kert Davies
Environmental Working Group
1718 Connecticut Ave. NW, Suite 600
Washington, D.C.  20009
kert@ewg.org  WWWeb: http://www.ewg.org
202-667-6982  fax 202-232-2592
Any opinions expressed are mine and not my employer's.
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