E7-17769. 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 [phone].

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 [phone].

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: [phone]; e-mail address: [e-mail].

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.

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.