Document ID: EPA-HQ-OPP-2007-0884-0001
Agency: epa
Document Type: Notice
Title: Experimental Use Permit; Receipt of Application
Posted Date: 2007-09-12T04:00Z

[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]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0884; FRL-8145-4]

 
Experimental Use Permit; Receipt of Application

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

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]

BILLING CODE 6560-50-S