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Bacillus thuringiensis var. tenebrionis - Receipt for Registration Application 11/1993

Receipt of an Application for Pesticide Registration for a Transgenic
Plant Pesticide
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
SUMMARY: EPA has received an application from the Monsanto Company
for a transgenic plant pesticide registration containing the
new active ingredient Bacillus thuringiensissubsp. tenebrionis
delta endotoxin protein as produced by the CryIIIA gene and
its controlling sequences. The EPA File Symbol for this application
is 524-UTU, and the associated tolerance petition number is
PP 3F4273. This is the first application for registration of
a transgenic plant pesticide under section 3(c)(4) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended,
in which a plant has been genetically altered to produce a pesticide.
Because of its uniqueness, the Agency has determined that this
application may be of regional and national significance. Therefore,
in accordance with 40 CFR 172.11(a), the Agency is soliciting
public comments on this application.
DATES: Written comments must be received on or before January
7, 1994.
ADDRESSES: By mail submit comments identified by the document
control number [OPP-0930355] and the (File Symbol 524-UTU) to:
Public Response and Program Resources Branch, Field Operations
Division (7506C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In
person, bring comments to: Rm. 1128, CM #2, 1921 Jefferson Davis
Highway, Arlington, VA.
   Information submitted in any comment concerning this notice
may be claimed confidential by marking any part, or all of that
information as "Confidential Business Information" (CBI).
Information so marked, will not be disclosed except in accordancewith
procedures set forth in 40 CFR part 2. A copy of the comment
that does not contain CBI must be submitted for inclusion in
the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice to the submitter.
Written comments will be available for public inspection in
Rm.1128 at the address given above, from 8 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal holidays.
Product Manager (PM) 18, Registration Division (7505C), Office
of Pesticide programs, Environmental Protection Agency, 401
M St., SW., Washington, DC 20460. Office location and telephone
number: Rm. 213, CM #2, 1921 Jefferson Davis Highway, Arlington,
VA, (703)-930-509-7690.
SUPPLEMENTARY INFORMATION: On September 3, 1993, an application
to register a transgenic plant pesticide containing a new active
ingredient was received from Monsanto Company, 700 Chesterfield
Village Parkway, St. Louis, MO 63198. The application was assigned
EPA File Symbol 524-UTU. Monsanto has formally applied for registration
of their plant pesticide Bacillus thuringiensis var. tenebrionis
(B.t.t.) Colorado potato beetle (CPB) control protein (CryIIIA).
Monsanto has genetically modified potato plants to produce the
pesticide control protein derived from the common soil bacterium
Bacillus thuringiensis subsp. tenebrionis (B.t.t.). The protein
produced by CPB resistant potatoes is identical to that found
in nature. Monsanto has genetically engineered Russett Burbank
potatoes by using a plant expressed vector that transferred
the CryIIIA and nptII genes into the genomic DNA of the potato
plants. Monsanto has isolated the CryIIIA gene from Bacillus
thuringiensis subsp. tenebrionis (B.t.t.) which encodes the
Colorado potato beetle active protein. Monsanto has improved
the gene for expression in plants and transferred it into potato
plant to produce the natural identical B.t.t. protein pest control
agent. This allows for the continuous pesticidal effect on the
potato plant pesticide. In addition, the engineered potato plants
express an enzyme, neomycin phosphotransferase II, which allows
for selective growth of transformed plant cells on kanamycin
during plant tissue culture. The purpose of Monsanto's application
for pesticide registration, and exemption from the requirements
of a tolerance, is to acquire a registration so that commercialization
of their new and innovative product can be available for commercial
use in control of the persistent pest, the Colorado potato beetle.
   Notice of approval or denial of an application to register
a pesticide product will be announced in the Federal Register.
The procedure for requesting data will be given in the Federal
Register if an application is approved.
   Comments received within the specified time period will beconsidered
before a final decision is made; comments received after the
time specified will be considered only to the extent possible
without delaying processing of the application.
   Written comments filed pursuant to this notice will be available
in the Public Response and Program Resources Branch, Field Operations
Division (FOD) office at the address provided above from 8 a.m.
to 4 p.m., Monday through Friday, except legal holidays. For
persons interested in reviewing the application file, It is
suggested to telephone the FOD office (703-305-5805) to ensure
that the file is available on the date of intended visit.

   Authority: 7 U.S.C. 136.

List of Subjects

   Environmental protection, Pesticides and pests, Product registration.
   Dated: November 22, 1993.

Stephen L. Johnson,

Acting Director, Registration Division, Office of Pesticide

[FR Doc. 93-29717 Filed 12-7-93; 8:45 am]