[Federal Register: December 19, 2007 (Volume 72, Number 243)]
[Notices]
[Page 71907-71908]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19de07-66]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-1047; FRL-8343-4]
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-97
from Monsanto Company requesting an amendment to the experimental use
permit (EUP) for Bacillus thuringiensis Cry1A.105 protein and the
genetic material necessary for its production (vector PV-ZMIR245) in
event MON 89034 corn, Bacillus thuringiensis Cry2Ab2 protein and the
genetic material necessary for its production (vector PV-ZMIR245) in
event MON 89034 corn, and Bacillus thuringiensis Cry3Bb1 protein and
the genetic material (vector PV-ZMIR39) necessary for its production in
event MON 88017 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 January 18, 2008.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-1047, 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-
2007-1047. 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., 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: cerrelli.susanne@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 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).
[[Page 71908]]
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
On June 29, 2006, EPA approved Monsanto's application for an EUP
for the testing of MON 89034 x MON 88017 combined insecticidal trait
corn as well as MON 89034 and MON 88017 individually (524-EUP-97). This
permit allows planting through June 20, 2008. MON 89034 contains the
lepidopteran protecting Bacillus thuringiensis Cry1A.105 protein and
the genetic material necessary (vector PV-ZMIR245) for its production
in MON 89034 corn and Bacillus thuringiensis Cry2Ab2 protein and the
genetic material necessary (vector PV-ZMIR245) for its production in
MON 89034 corn. MON 88017 contains the corn rootworm protecting
Bacillus thuringiensis Cry3Bb1 protein and the genetic material
necessary (vector PV-ZMIR39) for its production in MON 88017 corn.
Monsanto proposes amending the EUP to allow the treatment of 11,952
acres in total. This includes a maximum of 4,421 acres for MON 89034 x
MON 88017, 3,687 acres of MON 89034, 1,742 acres of MON 88017, 415
acres of corn containing registered plant-incorporated protectants
(PIPS) and 1,687 acres of non-PIP and border rows. The proposed period
of use of this amended EUP is February 15, 2008-June 15, 2009.
Eight trial protocols are proposed to be conducted including:
Breeding and observation nursery.
Inbred seed increase and sample hybrid production.
Line per se hybrid 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 include: Alabama, Arizona,
California, Colorado, Delaware, Florida, Georgia, Hawaii, Idaho,
Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland,
Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska,
New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma,
Oregon, Pennsylvania, Puerto Rico, South Carolina, 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: December 10, 2007.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. E7-24601 Filed 12-18-07; 8:45 am]
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