[Federal Register Volume 73, Number 196 (Wednesday, October 8, 2008)]
[Pages 58954-58956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-23860]



[EPA-HQ-OPP-2007-0179; FRL-8384-3]

Pesticide Experimental Use Permit; Receipt of Amendment 
Application; Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.


SUMMARY: This notice announces EPA's receipt of an application 264-EUP-
140 from Bayer CropScience requesting to amend and extend the existing 
an experimental use permit (EUP) for the Bacillus thuringiensis Cry1Ab 
protein and the genetic material necessary for its production in event 
T303-3 and T304-40 cotton plants. The Agency has determined that the 
permit 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 November 7, 2008.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2007-0179, 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

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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. 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 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: 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].


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 person 

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 
    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 

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 application may be of regional and national significance, 
and therefore is seeking public comment on the EUP application:
    Submitter: Bayer CropScience, (264-EUP-140).
    Pesticide Chemical: 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 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) and 
on August 28, 2008 (a separate document is published elsewhere in this

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Federal Register). Under the existing EUP, plantings are permitted 
through January 31, 2009. Bayer CropScience 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, 2009 until December 31, 2010. The Cry1Ab 
protein is effective in controlling lepidopteran larvae such as 
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, Arizona, Arkansas, California, Florida, 
Georgia, Louisiana, Mississippi, North Carolina, South Carolina, 
Tennessee, Texas, and in Puerto Rico. The proposed experimental program 
includes trials to evaluate insect and herbicide efficacy and agronomic 
performance. Also proposed is the production of sample material for 
regulatory studies and seed production for future experimental field 
trial plantings.
    A copy of the application and any information submitted is 
available for public review in the docket established for this EUP 
application as described under ADDRESSES.
    Following the review of the application and any comments and data 
received in response to this solicitation, EPA will decide whether to 
issue or deny the EUP request, and if issued, the conditions under 
which it is to be conducted. Any issuance of an EUP will be announced 
in the Federal Register.

List of Subjects

    Environmental protection, Experimental use permits.

    Dated: September 19, 2008.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

[FR Doc. E8-23860 Filed 10-7-08; 8:45 am]