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Experimental Use Permit; Receipt of Application
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: November 8, 2006 (Volume 71, Number 216)]
[Notices]
[Page 65508-65509]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08no06-71]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2006-782; FRL-8095-7]
Experimental Use Permit; Receipt of Application
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces receipt of an application 67979-EUP-A
from Syngenta Seeds, Inc. requesting an experimental use permit (EUP)
for the plant-incorporated protectants MIR162 Bacillus thuringiensis
Vip3A protein and the genetic material (plasmid vector pNOV1300)
necessary for its production in corn, Bt11 Bacillus thuringiensis
Cry1Ab protein and the genetic material (plasmid vector pZO1502)
necessary for its production in corn, and MIR604 Bacillus thuringiensis
mCry3A protein and the genetic material (plasmid vector pZM26)
necessary for its production in corn. The Agency has determined that
the application may be of regional and national significance.
Therefore, in accordance with 40 CFR 172.11(a), the Agency is
soliciting comments on this application.
DATES: Comments must be received on or before December 8, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-782, by one of the following methods:
? Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
? Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
? Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-782. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are available
either in the electronic docket at http://www.regulations.gov,
or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation
of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Alan Reynolds, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 605-0515; e-mail
address: reynolds.alan@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general. This action may,
however, be of interest to those interested in agricultural
biotechnology and those persons who are or may be required to conduct
testing of chemical substances under the Federal Food, Drug, and
Cosmetic Act (FFDCA) or the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). Since other entities may also be interested,
the Agency has not attempted to describe all the specific entities that
may be affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
[[Page 65509]]
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
The 67979-EUP-A application is for 536 acres of MIR162, 220 acres
of Bt11, 199 acres of MIR604, 469 acres of Bt11 x MIR162, 468 acres of
Bt11 x MIR162 x MIR604, and 1,207 acres of non plant-incorporated
protectant border areas. MIR162 contains the lepidopteran protecting
Bacillus thuringiensis Vip3A protein and the genetic material (plasmid
vector pNOV1300) necessary for its production. Bt11 contains the
lepidopteran protecting Bacillus thuringiensis Cry1Ab protein and the
genetic material (plasmid vector pZO1502) necessary for its production.
MIR604 contains the coleopteran protecting Bacillus thuringiensis
mCry3A protein and the genetic material (plasmid vector pZM26)
necessary for its production.
Proposed shipment/use dates are March 1, 2007 through February 29,
2008. Five trial protocols have been proposed, including the following:
? Breeding and observation.
? Efficacy evaluation.
? Agronomic observation.
? Inbred and hybrid seed production.
? Regulatory studies.
States and commonwealths involved include: California, Colorado,
Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas,
Kentucky, Louisiana, Maryland, Minnesota, Mississippi, Missouri,
Nebraska, New York, Ohio, Puerto Rico, South Dakota, Texas, and Wisconsin.
III. What Action is the Agency Taking?
Following the review of the Syngenta Seeds, Inc. application and
any comments and data received in response to this notice, EPA will
decide whether to issue or deny the EUP request for this EUP program,
and if issued, the conditions under which it is to be conducted. Any
issuance of an EUP will be announced in the Federal Register.
IV. What is the Agency's Authority for Taking this Action?
The Agency's authority for taking this action is under FIFRA section 5.
List of Subjects
Environmental protection, Experimental use permits.
Dated: October 27, 2006.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. E6-18941 Filed 11-7-06; 8:45 am]
BILLING CODE 6560-50-S