Document ID: EPA-HQ-OPP-2008-0135-0001
Agency: epa
Document Type: Notice
Title: Experimental Use Permit; Receipt of Application
Posted Date: 2008-04-16T04:00Z

[Federal Register: April 16, 2008 (Volume 73, Number 74)]
[Notices]               
[Page 20625-20626]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ap08-45]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0135; FRL-8357-8]

 
Experimental Use Permit; Receipt of Application

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces receipt of an application 524-EUP-00 
from Monsanto Company requesting an experimental use permit (EUP) for 
the plant-incorporated protectants: 1) Bacillus thuringiensis Cry1A.105 
protein and the genetic material necessary for its production (vector 
PV-ZMIR245) in event MON 89034 corn, 2) Bacillus thuringiensis Cry2Ab2 
protein and the genetic material necessary for its production (vector 
PV-ZMIR245) in event MON 89034 corn, 3) Bacillus thuringiensis Cry3Bb1 
protein and the genetic material necessary for its production (Vector 
ZMIR39) in Event MON 88017 corn (Organization for Economic Cooperation 
and Development (OECD) Unique Identifier: MON-88017-3), 4) Bacillus 
thuringiensis subspecies Cry1F protein and the genetic material 
necessary for its production (plasmid insert PHI 8999) in corn, and 5) 
Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic 
material necessary for their production (plasmid insert PHP 17662) in 
Event DAS-59122-7 corn. 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 May 16, 2008.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2008-0135, 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-
2008-0135. 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

[[Page 20626]]

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 (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: mendelsohn.mike@epa.gov.

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 and Dow AgroSciences have used conventional 
breeding techniques to produce the combined trait corn product MON 
89034 (Cry1A.105 and Cry2Ab2) x TC1507 (Cry1F) x MON 88017 (Cry3Bb1) x 
DAS-59122-7 (Cry34Ab1 and Cry35Ab1) that provides insect protection 
against lepidopteran insects including European corn borer, as well as 
the coleopteran corn rootworms. Monsanto has submitted an EUP 
application to test 383 acres of the combined trait product, 2,570 
acres of the intermediate breeding combinations, 190 acres of MON 
89034, 509 acres of other registered plant-incorporated protectants, 
and 1,341 acres of non-plant-incorporated protectant corn acres and 
border rows through June 30, 2009.
    Trial protocols to be conducted include:
     Breeding and observation nursery.
     Inbred seed increase and sample hybrid production.
     Line per se.
     Hybrid yield and herbicide tolerance.
     Insect efficacy.
     Product characterization and performance.
     Insect resistant management.
     Seed treatment.
    States involved include: Alabama, Arkansas, California, Colorado, 
Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, 
Louisiana, Maryland, Michigan, Minnesota, Mississippi, Missouri, 
Nebraska, New York, North Carolina, Ohio, Oregon, Pennsylvania, Puerto 
Rico, South Dakota, Tennessee, Texas, Washington, and Wisconsin.

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: April 7, 2008.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

[FR Doc. E8-8004 Filed 4-15-08; 8:45 am]

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