[Federal Register Volume 75, Number 226 (Wednesday, November 24, 2010)]
[Notices]
[Pages 71699-71701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29223]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0926; FRL-8853-7]


Pesticide Experimental Use Permits; Receipt of Amendment and 
Extension Applications; Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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 (TwinLinkTM 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 (703) 305-5805.
    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 (703) 305-5805.

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: (703) 308-8263; 
e-mail address: [email protected].
    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: (703) 308-8097; e-mail 
address: [email protected].

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

[[Page 71700]]

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

[[Page 71701]]

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.
[FR Doc. 2010-29223 Filed 11-23-10; 8:45 am]
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