Document ID: EPA-HQ-OPP-2010-0628-0001
Agency: epa
Document Type: Notice
Title: Pesticide Experimental Use Permits: Receipt of Application; Comment Request
Posted Date: 2010-08-18T04:00Z

[Federal Register: August 18, 2010 (Volume 75, Number 159)]
[Notices]               
[Page 51043-51045]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18au10-91]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0628; FRL-8839-8]

 
Pesticide Experimental Use Permit; Receipt of Application; 
Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice announces EPA's receipt of an application 524-EUP-
RNR from Monsanto Company requesting an experimental use permit (EUP) 
for the plant-incorporated protectants (PIPs), Bacillus thuringiensis 
(Bt ) Vip3Aa19

[[Page 51044]]

protein and the genetic material necessary for its production (vector 
pCOT1) in event COT102 cotton, Bt Cry1Ac protein and the genetic 
material necessary for its production (vector PV-GHBK04) in event MON 
15985 cotton, and Bt Cry2Ab2 protein and the genetic material necessary 
for its production (vector PV-GHBK11) in event MON 15985 cotton. 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 September 17, 2010.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2010-0628, 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-
2010-0628. 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: greenway.denise@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 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 
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

[[Page 51045]]

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 the Federal Insecticide, Fungicide and 
Rodenticide Act (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: Monsanto Company, (524-EUP-RNR).
    Pesticide Chemical: Bacillus thuringiensis (Bt ) Vip3Aa19 protein 
and the genetic material necessary for its production (vector pCOT1) in 
event COT102 cotton, Bt Cry1Ac protein and the genetic material 
necessary for its production (vector PV-GHBK04) in event MON 15985 
cotton, and Bt Cry2Ab2 protein and the genetic material necessary for 
its production (vector PV-GHBK11) in event MON 15985 cotton.
    Summary of Request: The non-food 524-EUP-RNR application is for 
1897 acres of PIP test materials, 909 acres of non-PIP materials, and 
10857 acres of border plantings for a total of 13,663 acres. Proposed 
shipment/use dates are December 1, 2010 to June 30, 2012.
    Eight trial protocols will be conducted:
     Breeding and observation nursery.
     Seed increase.
     Yield and herbicide tolerance trials.
     Insect efficacy trials.
     Product characterization and performance trials.
     Insect resistance management trials.
     Benefit trials.
     Seed treatment trials.
    States and Commonwealth involved are: Alabama, Arkansas, Arizona, 
California, Florida, Georgia, Hawaii, Kansas, Kentucky, Louisiana, 
Maryland, Missouri, Mississippi, New Mexico, North Carolina, Oklahoma 
Puerto Rico, South Carolina, Tennessee, Texas and Virginia.
    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: August 9, 2010.
W. Michael McDavit,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.

[FR Doc. 2010-20174 Filed 8-17-10; 8:45 am]
BILLING CODE 6560-50-S