Pesticide Experimental Use Permits; Receipt of Amendment and Extension Applications; Comment Request, 71699-71701 [2010-29223]

Download as PDF Federal Register / Vol. 75, No. 226 / Wednesday, November 24, 2010 / Notices Bioscience, Inc., 12085 Research Drive, Suite 185, Alachua, FL 32615). Product name: Pasteuria reniformis—Pr3. Active ingredient: Pasteuria reniformis—Pr3 at 0.01%. Proposed classification/Use: Manufacturing-use product. File symbol: 87485–E. Docket number: EPA–HQ–OPP–2010–0685. Applicant: Michael T. Novak; Keller and Heckman, LLP; 1001 G Street, NW.; Washington, DC 20001(on behalf of DSM Food Specialities BV; P.O. Box 12600 MA Delft; The Netherlands). Product name: Natamycin L. Active ingredient: Natamycin at 10.34%. Proposed classification/Use: Fungicide. File symbol: 87485–R. Docket number: EPA–HQ–OPP–2010–0685. Applicant: Michael T. Novak; Keller and Heckman, LLP; 1001 G Street, NW.; Washington, DC 20001(on behalf of DSM Food Specialities BV, P.O. Box 12600 MA Delft; The Netherlands). Product name: NATAMYCIN TGAI. Active ingredient: Natamycin at 91.02%. Proposed classification/Use: Technical product. List of Subjects Environmental protection, Pesticides and pests. Dated: November 9, 2010. W. Michael McDavit, Acting Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. [FR Doc. 2010–29224 Filed 11–23–10; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2010–0926; FRL–8853–7] Pesticide Experimental Use Permits; Receipt of Amendment and Extension Applications; Comment Request Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: 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 WReier-Aviles on DSKGBLS3C1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 15:30 Nov 23, 2010 Jkt 223001 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: https:// 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 https:// 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 email. 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 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 71699 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 https://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 https:// 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: greenway.denise@epa.gov. 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: bacchus.shanaz@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 E:\FR\FM\24NON1.SGM 24NON1 71700 Federal Register / Vol. 75, No. 226 / Wednesday, November 24, 2010 / Notices WReier-Aviles on DSKGBLS3C1PROD with NOTICES 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 VerDate Mar<15>2010 15:30 Nov 23, 2010 Jkt 223001 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: Plantincorporated 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 Cry1Abcontaining 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 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 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 conducttesting 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 E:\FR\FM\24NON1.SGM 24NON1 Federal Register / Vol. 75, No. 226 / Wednesday, November 24, 2010 / Notices 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] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [FRL–9230–7] Science Advisory Board Staff Office; Request for Nominations of Experts for the Review of a Draft Microbial Risk Assessment Guideline: Pathogenic Microorganisms in Food and Water Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: The EPA Science Advisory Board (SAB) Staff Office is requesting public nominations for technical experts to form an SAB panel to review a draft interagency Microbial Risk Assessment Guideline: Pathogenic Microorganisms in Food and Water (the Guideline) which provides a flexible framework for conducting microbial risk assessment that may be applied by different agencies with various statutory authorities. WReier-Aviles on DSKGBLS3C1PROD with NOTICES SUMMARY: Nominations should be submitted by December 15, 2010 per instructions below. DATES: VerDate Mar<15>2010 15:30 Nov 23, 2010 Jkt 223001 Any member of the public wishing further information regarding this Notice and Request for Nominations may contact Mr. Thomas Carpenter, Designated Federal Officer (DFO), SAB Staff Office, by telephone/voice mail at (202) 564– 4885, by fax at (202) 565–2098, or via e-mail at carpenter.thomas@epa.gov. General information concerning the EPA Science Advisory Board can be found at the EPA SAB Web site at https:// www.epa.gov/sab. SUPPLEMENTARY INFORMATION: Background: The SAB (42 U.S.C. 4365) is a chartered Federal Advisory Committee that provides independent scientific and technical peer review, advice, consultation, and recommendations to the EPA Administrator on the technical basis for EPA actions. As a Federal Advisory Committee, the SAB conducts business in accordance with the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2) and related regulations. The SAB will comply with the provisions of FACA and all appropriate SAB Staff Office procedural policies. EPA and the U.S. Department of Agriculture (USDA) are leading the Interagency Microbial Risk Assessment (MRA) Guideline Workgroup to develop a Guideline to improve transparency in how Federal agencies conduct MRA and promote consistency in terms of approaches and methods. The Guideline is intended to be a resource for U.S. Federal Government risk assessors, their contractors, and the general risk assessment community. The draft Guideline is focused on infectious diseases associated with the gastrointestinal tract and fecal/oral transmission through food and water but has utility to a broader variety of scenarios. It applies to human pathogens including viruses, bacteria, protozoa, and fungi. In addition to issues in common with chemical risk assessment the document addresses issues that are unique to MRA such as secondary transmission, variation in immune status, and fluctuation in microbial populations. The EPA Office of the Science Advisor’s Risk Assessment Forum has requested the SAB to review the draft Microbial Risk Assessment Guideline: Pathogenic Microorganisms in Food and Water to assess the appropriateness of the Guideline to provide technical guidance and its efficacy as a resource in conducting MRA. The SAB Staff Office will consider nominations received in response to this FR Notice, members of the Science Advisory Board, and the USDA National Advisory FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 71701 Committee on Microbiological Criteria for Foods (NACMCF) to form an expert panel under the auspices of the SAB to review the draft MRA Guideline. Request for Nominations: The SAB Staff Office is seeking nominations of nationally and internationally recognized scientists and risk assessors with demonstrated expertise and research or management experience in one or more of the following areas: Microbiology, infectious disease, food safety, exposure assessment, biostatistics, public health, risk assessment and risk communication. We are particularly interested in scientists and risk assessors with direct experience in the design, management, and implementation of public health protection programs that have included development of approaches to assess exposure reduction to food- and waterborne pathogens. Availability of the review materials: Information on the Guideline is available on the EPA Risk Assessment Forum Web site https://www.epa.gov/raf/ microbial.htm. For questions concerning the MRA Guideline, please contact Dr. Kathryn Gallagher, Executive Director, Risk Assessment Forum, Office of the Science Advisor US EPA, Mail Code, 8105R, 1200 Pennsylvania Ave, NW., Washington, DC 20460, (phone) 202– 564–1398 (fax) 202–564–2070 or at gallagher.kathryn@epa.gov. Process and Deadline for Submitting Nominations: Any interested person or organization may nominate qualified individuals in the areas of expertise described above for possible service on this expert Panel. Nominations should be submitted in electronic format (which is preferred over hard copy) following the instructions for ‘‘Nominating Experts to Advisory Panels and Ad Hoc Committees Being Formed’’ provided on the SAB Web site. The instructions can be accessed through the ‘‘Nomination of Experts’’ link on the blue navigational bar on the SAB Web site at https://www.epa.gov/sab. To receive full consideration, nominations should include all of the information requested below. EPA’s SAB Staff Office requests contact information about the person making the nomination; contact information about the nominee; the disciplinary and specific areas of expertise of the nominee; the nominee’s curriculum vita; sources of recent grant and/or contract support; and a biographical sketch of the nominee indicating current position, educational background, research activities, and recent service on other national advisory committees or national professional organizations. E:\FR\FM\24NON1.SGM 24NON1

Agencies

[Federal Register Volume 75, Number 226 (Wednesday, November 24, 2010)]
[Notices]
[Pages 71699-71701]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29223]


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

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.

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

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: https://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 https://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 https://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 https://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: greenway.denise@epa.gov.
    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: bacchus.shanaz@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

[[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]
BILLING CODE 6560-50-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.