[Federal Register Volume 74, Number 4 (Wednesday, January 7, 2009)]
[Notices]
[Pages 710-711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-31410]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0135; FRL-8397-5]


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's receipt of an application 524-EUP-
99 from Monsanto Company requesting an amendment to the 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 (vector PHI 8999) in 
corn, and 5) Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and 
the genetic material necessary for their production (vector PHP 17662) 
in Event DAS-59122-7 corn. 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 February 6, 2009.

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 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-
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 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: Susanne Cerrelli, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8077; 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:

[[Page 711]]

    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 amendment application may be of regional and national 
significance, and therefore is seeking public comment on the EUP 
amendment application:
    Submitter: Monsanto Company, (524-EUP-99).
    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 (OECD Unique Identifier: MON-88017-3), 
4) Bacillus thuringiensis subspecies Cry1F protein and the genetic 
material necessary for its production (vector PHI 8999) in corn, and 5) 
Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic 
material necessary for their production (vector PHP 17662) in Event 
DAS-59122-7 corn.
    Summary of Request: On July 17, 2008, EPA approved Monsanto 
Company's application for an EUP for the testing of 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) as well as other 
event sub-combinations through June 30, 2009, appears elsewhere in this 
issue of the Federal Register. Monsanto proposes amending the EUP 
application to allow testing on a maximum 17,777.42 total program acres 
with a proposed planting season from February 15, 2009 through June 13, 
2010. This acreage includes 3,736.72 acres of combined trait product, 
MON 89034 x TC1507 x MON 88017 x DAS-59122-7; 4,906.85 acres of other 
event sub-combinations; 5,257.82 acres of other corn containing 
registered plant-incorporated protectants to be used as comparators in 
these trials; and 3,876.03 acres of non-plant-incorporated protectant 
corn acres and border rows.
    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.
     Benefits trials.
     Seed treatment.
    States and territories involved include: Alabama, Arkansas, 
California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, 
Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, 
Missouri, Nebraska, New York, North Carolina, Ohio, Oklahoma, 
Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, 
Texas, Washington, and Wisconsin.
    A copy of the amendment application and any information submitted 
is available for public review in the docket established for this EUP 
amendment application as described under ADDRESSES.
    Following the review of the amendment 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: December 29, 2008.
W. Michael McDavit,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.
[FR Doc. E8-31410 Filed 1-7-08; 8:45 am]
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