[Federal Register Volume 73, Number 45 (Thursday, March 6, 2008)]
[Notices]
[Pages 12170-12171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-4345]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0134; FRL-8353-8]


Experimental Use Permit; Receipt of Application; Amendment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces receipt of an application 524-EUP-1 from 
Monsanto Company requesting to amend and extend an experimental use 
permit (EUP) for the plant-incorporated protectant Bacillus 
thuringiensis Cry1Ac protein and the genetic material necessary for its 
production (vector PV-GMIR9) in event MON 87701 soybean. 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 April 7, 2008.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2008-0134, 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-
2008-0134. 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.,

[[Page 12171]]

Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Mike Mendelsohn, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8715; 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 interested in agricultural 
biotechnology or those who are or may be required to conduct testing of 
chemical 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 
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.

II. Background

    Monsanto Company has developed an insect-protected soybean, MON 
87701, that produces the Cry1Ac protein to provide protection from 
feeding damage from certain lepidopteran pests. The 524-EUP-1 
application is for 133.10 acres of MON 87701 and 156.52 acres of non-
plant-incorported protectant and border acres for plantings through 
July 31, 2009. A total of five trial protocols will be conducted, 
including: Agronomic yield trials, breeding and observation nursery 
trials, regulatory trials, product characterization and efficacy 
trials, and product development trials. States involved include: 
Alabama, Arkansas, Georgia, Illinois, Indiana, Kansas, Louisiana, 
Maryland, Mississippi, Missouri, North Carolina, Oklahoma, Puerto Rico, 
South Carolina, Tennessee, Texas, and Virginia.

III. What Action is the Agency Taking?

    Following the review of the Monsanto Company 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: February 27, 2008.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

[FR Doc. E8-4345 Filed 3-5-08; 8:45 am]
BILLING CODE 6560-50-S