2010-29223. Pesticide Experimental Use Permits; Receipt of Amendment and Extension Applications; Comment Request

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces EPA's receipt of applications 264-EUP-140 and 264-EUP-143 from Bayer CropScience LP requesting to amend and extend the existing experimental use permits (EUPs) for the active ingredients Bacillus thuringiensis Cry1Ab protein and the genetic material necessary for its production in event T303-3 and T304-40 cotton plants (264-EUP-140); and Bacillus thuringiensis Cry2Ae protein and the genetic material necessary for its production in event GHB119 and GHB714 cotton plants and Bacillus thuringiensis Cry1Ab x Cry2Ae combined trait cotton (TwinLink^TM Cotton) plant lines (264-EUP-143). The Agency has determined that the permits may be of regional and national significance. Therefore, in accordance with 40 CFR 172.11(a), the Agency is soliciting comments on these applications.

DATES:

Comments must be received on or before December 27, 2010.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2007-0179 for 264-EUP-140 or EPA-HQ-OPP-2007-0884 for 264-EUP-143, 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 Facility'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-2007-0179 for 264-EUP-140 or EPA-HQ-OPP-2007-0884 for 264-EUP-143. 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 Web site 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 at http://www.regulations.gov. 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:

For 264-EUP-140, Denise Greenway, 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].

For 264-EUP-143, Shanaz Bacchus, 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 are interested in agricultural biotechnology or may be required to conduct testing of pesticidal 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 appropriate 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.

viii. Make sure to submit your comments by the comment period deadline identified.

3. Environmental justice. EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticide(s) discussed in this document, compared to the general population.

II. What action is the agency taking?

Under section 5 of FIFRA, 7 U.S.C. 136c, EPA can allow manufacturers to field test pesticides under development. Manufacturers are required to obtain an EUP before testing new pesticides or new uses of pesticides if they conduct experimental field tests on 10 acres or more of land or one acre or more of water.

Pursuant to 40 CFR 172.11(a), the Agency has determined that the following EUP applications may be of regional and national significance, and therefore is seeking public comment on the EUP applications:

Submitter: Bayer CropScience LP, (264-EUP-140).

Pesticide Chemical: Plant-incorporated protectants (PIPs) Bacillus thuringiensis Cry1Ab protein and the genetic material necessary for its production in event T303-3 and T304-40 cotton plants.

Summary of Request: Bayer CropScience LP has requested an amendment and extension of EUP 264-EUP-140, which was first granted by EPA on February 7, 2006 (71 FR 41020; July 19, 2006; FRL-8060-6), and was amended on March 8, 2007 (72 FR 34009; June 20, 2007; FRL-8133-5), on August 28, 2008 (73 FR 58949; October 8, 2008; FRL-8384-9), and on November 24, 2008 (74 FR 10571; March 11, 2009; FRL-8398-2). Under the existing EUP, plantings are permitted through December 31, 2010. Bayer CropScience LP is now proposing to amend the experimental program by conducting testing on 152 acres (out of 1,602 total acres) planted to Cry1Ab-containing cotton, with up to 0.03 pound of Cry1Ab protein and the genetic material necessary for its production in events T303-3 and T304-40; and to extend the amended program to run from January 1, 2011 until December 31, 2011. The company is researching the potential of this cotton PIP, Cry1Ab protein, for control of lepidopteran larvae such as cotton bollworm (Helicoverpa zea) and tobacco budworm (Heliothis virescens), which are common pests of cotton. The proposed program will be carried out in the States of Alabama, Arkansas, Arizona, California, Florida, Georgia, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee, Texas, and the United States territory of Puerto Rico. The proposed experimental program includes trials to evaluate insect and herbicide efficacy, agronomic performance, and breeding lines. Also proposed is the production of seed for future plantings of experimental and regulatory field trials.

Submitter: Bayer CropScience LP, (264-EUP-143).

Pesticide Chemical: Bacillus thuringiensis Cry2Ae protein and the genetic material necessary for its production in event GHB119 and GHB714 cotton PIPs, and Bacillus thuringiensis Cry1Ab x Cry2Ae combined trait cotton (TwinLink ^TM Cotton) PIPs.

Summary of Request: Bayer CropScience LP has requested an amendment and extension of EUP 264-EUP-143, which was first granted by EPA on September 1, 2008 (73 FR 65848; November 5, 2008; FRL-8388-6). Under the existing EUP, plantings are permitted through December 31, 2010. Bayer CropScience LP is now proposing to amend the experimental program to allow further evaluation of these cotton plant lines in a wider range of environmental conditions between January 1, 2011 and December 31, 2011. Testing is intended to include insect efficacy trials, agronomic performance evaluations, and herbicide efficacy evaluations, as well as the production of sample material for regulatory studies. The applicant requests to conduct-testing in 12 States: Alabama, Arkansas, Arizona, California, Florida, Georgia, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee, Texas, and the United States territory of Puerto Rico. Testing will be conducted on a total of 1,919 acres of which 152 acres will be planted to Cry2Ae and 307 acres will be planted to Cry1Ab x Cry2Ae combined trait cotton (TwinLink ^TM Cotton). The proposed experimental program requires up to 0.059 pound of Cry1Ab protein from the Cry1Ab x Cry2Ae combined trait cotton (Twinlink ^TM Cotton) and up to 0.021 pound of Cry2Ae protein from the Cry1Ab x Cry2Ae combined trait cotton (TwinLink ^TM Cotton) and the Cry2Ae cotton. The level of Cry1Ab and Cry2Ae protein in the different plant materials is only an estimation based on Bayer CropScience LP's current level of information. The company is researching the potential for Bacillus thuringiensis Cry2Ae and combined Cry1Ab and Cry2Ae proteins (TwinLink ^TM Cotton) produced by the inserted genetic material in these cotton PIPs for control of lepidopteran larvae such as cotton bollworm (Helicoverpa zea), tobacco budworm (Heliothis virescens), pink bollworm (Pectinophora gossypiella), fall armyworm (Spodoptera frugiperda), and beet armyworm (Spodoptera exigua). All cotton plants to be evaluated under this EUP contain the Cry2Ae protein and have been derived from either transformation event GHB119 or GHB714 or are combinations derived from either transformation event T303-3 or T304-40 and event GHB119 or GHB714.

A copy of the applications and any information submitted is available for public review in the dockets established for these EUP applications as described under ADDRESSES.

Following the review of the applications and any comments and data received in response to these solicitations, EPA will decide whether to issue or deny the EUP amendment and extension requests, and if issued, the conditions under which they are to be conducted. Any issuance of the EUPs will be announced in the Federal Register.

List of Subjects

• Environmental protection
• Experimental use permits

Dated: November 9, 2010.

W. Michael McDavit,

Acting Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.