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[Federal Register: June 28, 2011 (Volume 76, Number 124)]
[Notices]               
[Page 37769-37770]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jn11-42]                         

[[Page 37769]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2010-0102]

 
Bayer CropScience LP; Availability of Petition, Plant Pest Risk 
Assessment, and Environmental Assessment for Determination of 
Nonregulated Status for Cotton Genetically Engineered for Insect 
Resistance and Herbicide Tolerance

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has received a petition from Bayer CropScience LP 
seeking a determination of nonregulated status for cotton designated as 
TwinLink\TM\ cotton (events T304-40 and GHB119), which has been 
genetically engineered to be tolerant to the herbicide glufosinate and 
resistant to several lepidopteran pests. The petition has been 
submitted in accordance with our regulations concerning the 
introduction of certain genetically engineered organisms and products. 
We are soliciting comments on whether this genetically engineered 
cotton is likely to pose a plant pest risk. We are making available for 
public comment the Bayer petition, our plant pest risk assessment, and 
our draft environmental assessment for the proposed determination of 
nonregulated status.

DATES: We will consider all comments that we receive on or before 
August 29, 2011.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2010-0102-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2010-0102, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2010-
0102 or in our reading room, which is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 690-2817 before coming.
    Availability of Documents: The petition, draft environmental 
assessment, and plant pest risk assessment are available on the 
Regulations.gov Web site (see link above) and on the APHIS Web site at 
http://www.aphis.usda.gov/brs/aphisdocs/08_34001p.pdf, http://www.aphis.usda.gov/brs/aphisdocs/08_34001p_dea.pdf, and http://www.aphis.usda.gov/brs/aphisdocs/08_34001p_dpra.pdf.

FOR FURTHER INFORMATION CONTACT: Mr. Evan Chestnut, Policy Analyst, 
Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 146, 
Riverdale, MD 20737-1236; (301) 734-0942, e-mail: 
evan.a.chestnut@aphis.usda.gov. To obtain copies of the petition, draft 
environmental assessment, or plant pest risk assessment, contact Ms. 
Cindy Eck at (301) 734-0667, e-mail: cynthia.a.eck@aphis.usda.gov.

SUPPLEMENTARY INFORMATION: 

Background

    Under the authority of the plant pest provisions of the Plant 
Protection Act (7 U.S.C. 7701 et seq.), the regulations in 7 CFR part 
340, ``Introduction of Organisms and Products Altered or Produced 
Through Genetic Engineering Which Are Plant Pests or Which There Is 
Reason to Believe Are Plant Pests,'' regulate, among other things, the 
introduction (importation, interstate movement, or release into the 
environment) of organisms and products altered or produced through 
genetic engineering that are plant pests or that there is reason to 
believe are plant pests. Such genetically engineered organisms and 
products are considered ``regulated articles.''
    The regulations in Sec.  340.6(a) provide that any person may 
submit a petition to the Animal and Plant Health Inspection Service 
(APHIS) seeking a determination that an article should not be regulated 
under 7 CFR part 340. Paragraphs (b) and (c) of Sec.  340.6 describe 
the form that a petition for a determination of nonregulated status 
must take and the information that must be included in the petition.
    APHIS has received a petition (APHIS Petition Number 08-340-01p) 
from Bayer CropScience LP (Bayer), seeking a determination of 
nonregulated status for TwinLink\TM\ cotton (events T304-40 and 
GHB119), which has been genetically engineered to be tolerant to the 
herbicide glufosinate and resistant to several lepidopteran pests, 
stating that TwinLink\TM\ cotton is unlikely to pose a plant pest risk 
and, therefore, should not be a regulated article under APHIS' 
regulations in 7 CFR part 340.
    As described in the petition, TwinLink\TM\ cotton is a combined-
trait cotton developed using conventional breeding techniques to link 
two deoxyribonucleic acid (DNA) transformation events, each developed 
using DNA recombinant techniques. By crossing Bayer's Cry1Ab Cotton 
(event T304-40) with Bayer's Cry2Ae Cotton (event GHB119), Bayer has 
developed a cotton resistant to lepidopteran pests. The TwinLink\TM\ 
cotton also expresses a glufosinate ammonium herbicide tolerance trait 
based on LibertyLink[reg] technology. TwinLink\TM\ cotton is currently 
regulated under 7 CFR part 340. Interstate movement, importation, and 
field testing of TwinLink\TM\ cotton have been conducted under 
notifications acknowledged by APHIS.
    Field tests conducted under APHIS oversight allowed for evaluation 
in a natural agricultural setting while imposing measures to minimize 
the risk of persistence in the environment after completion of the 
test. Data are gathered on multiple parameters and used by the 
applicant to evaluate agronomic characteristics and product 
performance. These and other data are used by APHIS to determine if the 
new variety poses a plant pest risk.
    In section 403 of the Plant Protection Act, ``plant pest'' is 
defined as any living stage of any of the following that can directly 
or indirectly injure, cause damage to, or cause disease in any plant or 
plant product: A protozoan, a nonhuman animal, a parasitic plant, a 
bacterium, a fungus, a virus or viroid, an infectious agent or other 
pathogen, or any article similar to or allied with any of the 
foregoing. APHIS has prepared a plant pest risk assessment to determine 
if TwinLink\TM\ cotton is unlikely to pose a plant pest risk.
    APHIS has also prepared a draft environmental assessment (EA) in 
which it presents two alternatives based on its analyses of data 
submitted by Bayer, a review of other scientific data, and field tests 
conducted under APHIS oversight. APHIS is considering the following 
alternatives: (1) Take no action, i.e., APHIS would not change the 
regulatory status of TwinLink\TM\ cotton and it would continue to be a 
regulated article, or (2) make a determination of nonregulated status 
for TwinLink\TM\ cotton.
    The draft EA has been prepared to provide the APHIS decisionmaker 
with a review and analysis of any potential environmental impacts 
associated with the proposed determination of

[[Page 37770]]

nonregulated status for TwinLink\TM\ cotton. The draft EA was prepared 
in accordance with (1) the National Environmental Policy Act of 1969 
(NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of the 
Council on Environmental Quality for implementing the procedural 
provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations 
implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing 
Procedures (7 CFR part 372).
    In accordance with Sec.  340.6(d) of the regulations, we are 
publishing this notice to inform the public that APHIS will accept 
written comments regarding the petition for a determination of 
nonregulated status from interested or affected persons for a period of 
60 days from the date of this notice. We are also soliciting written 
comments from interested or affected persons on the plant pest risk 
assessment and the draft EA prepared to examine any potential 
environmental impacts of the proposed determination of the nonregulated 
status of the subject cotton lines. The petition, draft EA, and plant 
pest risk assessment are available for public review, and copies of the 
petition, draft EA, and plant pest risk assessment are available as 
indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. All comments received regarding the petition, draft EA, 
and plant pest risk assessment will be available for public review. 
After reviewing and evaluating the comments on the petition, the draft 
EA, plant pest risk assessment, and other data, APHIS will furnish a 
response to the petitioner, either approving or denying the petition. 
APHIS will also publish a notice in the Federal Register announcing the 
regulatory status of TwinLink\TM\ cotton and the availability of APHIS' 
written environmental decision and regulatory determination.

    Authority:  7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 
CFR 2.22, 2.80, and 371.3.

    Done in Washington, DC this 22nd day of June 2011.
John R. Clifford,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-16126 Filed 6-27-11; 8:45 am]
BILLING CODE 3410-34-P
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