[Federal Register: September 12, 2007 (Volume 72, Number 176)]
[Notices]
[Page 52127-52128]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12se07-86]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-0884; FRL-8145-4]
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 264-EUP-RUG
from Bayer CropScience (BCS) requesting an experimental use permit
(EUP) for the plant-incorporated protectants, Bacillus thuringiensis
Cry2Ae protein and the genetic material necessary for its production
(pTEM12) in Event GHB119 or GHB714 cotton plants and the Bacillus
thuringiensis Cry1Ab protein and the genetic material necessary for its
production (pTDL004 or pTDL008) in Event T303-3 or T304-40 cotton
plants. 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 October 12, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0884, 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
Bldg.), 2777 S. Crystal Dr., 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 Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-0884. 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 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
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
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 Bldg.),
2777 S. Crystal Dr., 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 Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Sharlene R. Matten, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 605-0514; e-mail
address: matten.sharlene@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 persons who may be required to conduct
testing 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 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.
[[Page 52128]]
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.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
BCS has requested an EUP, 264-EUP-RUG, to allow for the evaluation
of cotton plants that produce the insecticidal protein, Bacillus
thuringiensis Cry2Ae, as well as cotton plants that produce two
insecticidal proteins, Bacillus thuringiensis Cry1Ab and Cry2Ae, for
protection against lepidopteran cotton pests. For 2008, the proposed
acreage includes 94.75 acres of Events GHB119 and/or GHB714, 138.75
acres of Events T303-3 and/or T304-40 cotton plants and Events GHB119
and/or GHB714 cotton plants, and 434.50 acres of non plant-incorporated
protectant border areas (688 total acres). Cotton derived from
transformation events T303-3 or T304-40 express the plant-incorporated
protectant, Bacillus thuringiensis Cry1Ab protein (pTDL004 or pTDL008)
and the genetic material necessary for its production were included in
the previously granted EUP, 264-EUP-140. Cotton events GHB119 or GHB714
express the plant-incorporated protectant, Bacillus thuringiensis
Cry2Ae protein (pTEM12) and the genetic material necessary for its
production. These plants also contain a pesticidal inert ingredient as
a selectable marker, the phosphinothricin acetyltransferase (PAT)
protein that confers tolerance to glufosinate-ammonium herbicides.
The Cry1Ab and Cry2Ae proteins are being tested for their
effectiveness in controlling the following lepidopteran cotton pests:
Cotton bollworm (Helicoverpa zea), tobacco budworm (Heliothis
virescens), pink bollworm (Pectinophora gossypiella), fall armyworm
(Spodoptera frugiperda), and beet armyworm (Spodoptera exigua).
Four trial protocols have been proposed:
Introgression (nurseries), evaluation (line trials), and
seed increases.
Evaluation of the insecticidal efficacy against cotton
insect pests, under different degrees of insect pressure, in different
growing environments and in different genetic backgrounds.
Evaluation of the agronomic performance in different
genetic backgrounds and in different growing regions.
Generation of plant material and data to support future
regulatory submissions in the United States and other countries.
The states involved in the proposed EUP include: Mississippi, North
Carolina, South Carolina, Tennessee, and Texas. Proposed shipment/use
dates are March 1, 2008 to January 31, 2009.
III. What Action is the Agency Taking?
Following the review of the BCS 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: August 29, 2007.
W. Michael McDavit,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
[FR Doc. E7-17769 Filed 9-11-07; 8:45 am]
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