[Federal Register Volume 75, Number 226 (Wednesday, November 24, 2010)]
[Notices]
[Pages 71699-71701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29223]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2010-0926; FRL-8853-7]
Pesticide Experimental Use Permits; Receipt of Amendment and
Extension Applications; Comment Request
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces EPA's receipt of applications 264-EUP-
140 and 264-EUP-143 from Bayer CropScience LP requesting to amend and
extend the existing experimental use permits (EUPs) for the active
ingredients Bacillus thuringiensis Cry1Ab protein and the genetic
material necessary for its production in event T303-3 and T304-40
cotton plants (264-EUP-140); and Bacillus thuringiensis Cry2Ae protein
and the genetic material necessary for its production in event GHB119
and GHB714 cotton plants and Bacillus thuringiensis Cry1Ab x Cry2Ae
combined trait cotton (TwinLinkTM Cotton) plant lines (264-
EUP-143). The Agency has determined that the permits may be of regional
and national significance. Therefore, in accordance with 40 CFR
172.11(a), the Agency is soliciting comments on these applications.
DATES: Comments must be received on or before December 27, 2010.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0179 for 264-EUP-140 or EPA-HQ-OPP-2007-
0884 for 264-EUP-143, 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-
2007-0179 for 264-EUP-140 or EPA-HQ-OPP-2007-0884 for 264-EUP-143.
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 Web site 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: For 264-EUP-140, 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: [email protected].
For 264-EUP-143, Shanaz Bacchus, Biopesticides and Pollution
Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8097; 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 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
[[Page 71700]]
appropriate 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 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 applications may be of regional and national
significance, and therefore is seeking public comment on the EUP
applications:
Submitter: Bayer CropScience LP, (264-EUP-140).
Pesticide Chemical: Plant-incorporated protectants (PIPs) Bacillus
thuringiensis Cry1Ab protein and the genetic material necessary for its
production in event T303-3 and T304-40 cotton plants.
Summary of Request: Bayer CropScience LP has requested an amendment
and extension of EUP 264-EUP-140, which was first granted by EPA on
February 7, 2006 (71 FR 41020; July 19, 2006; FRL-8060-6), and was
amended on March 8, 2007 (72 FR 34009; June 20, 2007; FRL-8133-5), on
August 28, 2008 (73 FR 58949; October 8, 2008; FRL-8384-9), and on
November 24, 2008 (74 FR 10571; March 11, 2009; FRL-8398-2). Under the
existing EUP, plantings are permitted through December 31, 2010. Bayer
CropScience LP is now proposing to amend the experimental program by
conducting testing on 152 acres (out of 1,602 total acres) planted to
Cry1Ab-containing cotton, with up to 0.03 pound of Cry1Ab protein and
the genetic material necessary for its production in events T303-3 and
T304-40; and to extend the amended program to run from January 1, 2011
until December 31, 2011. The company is researching the potential of
this cotton PIP, Cry1Ab protein, for control of lepidopteran larvae
such as cotton bollworm (Helicoverpa zea) and tobacco budworm
(Heliothis virescens), which are common pests of cotton. The proposed
program will be carried out in the States of Alabama, Arkansas,
Arizona, California, Florida, Georgia, Louisiana, Mississippi, North
Carolina, South Carolina, Tennessee, Texas, and the United States
territory of Puerto Rico. The proposed experimental program includes
trials to evaluate insect and herbicide efficacy, agronomic
performance, and breeding lines. Also proposed is the production of
seed for future plantings of experimental and regulatory field trials.
Submitter: Bayer CropScience LP, (264-EUP-143).
Pesticide Chemical: Bacillus thuringiensis Cry2Ae protein and the
genetic material necessary for its production in event GHB119 and
GHB714 cotton PIPs, and Bacillus thuringiensis Cry1Ab x Cry2Ae combined
trait cotton (TwinLink \TM\ Cotton) PIPs.
Summary of Request: Bayer CropScience LP has requested an amendment
and extension of EUP 264-EUP-143, which was first granted by EPA on
September 1, 2008 (73 FR 65848; November 5, 2008; FRL-8388-6). Under
the existing EUP, plantings are permitted through December 31, 2010.
Bayer CropScience LP is now proposing to amend the experimental program
to allow further evaluation of these cotton plant lines in a wider
range of environmental conditions between January 1, 2011 and December
31, 2011. Testing is intended to include insect efficacy trials,
agronomic performance evaluations, and herbicide efficacy evaluations,
as well as the production of sample material for regulatory studies.
The applicant requests to conduct-testing in 12 States: Alabama,
Arkansas, Arizona, California, Florida, Georgia, Louisiana,
Mississippi, North Carolina, South Carolina, Tennessee, Texas, and the
United States territory of Puerto Rico. Testing will be conducted on a
total of 1,919 acres of which 152 acres will be planted to Cry2Ae and
307 acres will be planted to Cry1Ab x Cry2Ae combined trait cotton
(TwinLink \TM\ Cotton). The proposed experimental program requires up
to 0.059 pound of Cry1Ab protein from the Cry1Ab x Cry2Ae combined
trait cotton (Twinlink \TM\ Cotton) and up to 0.021 pound of Cry2Ae
protein from the Cry1Ab x Cry2Ae combined trait cotton (TwinLink \TM\
Cotton) and the Cry2Ae cotton. The level of Cry1Ab and Cry2Ae protein
in the different plant materials is only an estimation based on Bayer
CropScience LP's current level of information. The company is
researching the potential for Bacillus thuringiensis Cry2Ae and
combined Cry1Ab and Cry2Ae proteins (TwinLink \TM\ Cotton) produced by
the inserted genetic material in these cotton PIPs for control of
lepidopteran larvae such as cotton bollworm (Helicoverpa zea), tobacco
budworm (Heliothis virescens), pink bollworm (Pectinophora
gossypiella), fall
[[Page 71701]]
armyworm (Spodoptera frugiperda), and beet armyworm (Spodoptera
exigua). All cotton plants to be evaluated under this EUP contain the
Cry2Ae protein and have been derived from either transformation event
GHB119 or GHB714 or are combinations derived from either transformation
event T303-3 or T304-40 and event GHB119 or GHB714.
A copy of the applications and any information submitted is
available for public review in the dockets established for these EUP
applications as described under ADDRESSES.
Following the review of the applications and any comments and data
received in response to these solicitations, EPA will decide whether to
issue or deny the EUP amendment and extension requests, and if issued,
the conditions under which they are to be conducted. Any issuance of
the EUPs will be announced in the Federal Register.
List of Subjects
Environmental protection, Experimental use permits.
Dated: November 9, 2010.
W. Michael McDavit,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
[FR Doc. 2010-29223 Filed 11-23-10; 8:45 am]
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