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[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Notices]
[Pages 27301-27303]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11519]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2007-0130]

Syngenta Biotechnology, Inc.; Availability of Petition, Plant 
Pest Risk Assessment, and Environmental Assessment of Determination of 
Nonregulated Status for Lepidopteran-Resistant Cotton

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 Syngenta Biotechnology, 
Inc., seeking a determination of nonregulated status for cotton 
designated as event COT67B, which has been genetically engineered to 
express a protein to protect cotton plants from lepidopteran insect 
damage. 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 Syngenta 
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 July 
11, 2011.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0130 to submit or view comments and 
to view supporting and related materials available electronically.
     Postal Mail/Commercial Delivery: Please send one copy of 
your comment

[[Page 27302]]

to Docket No. APHIS-2007-0130, Regulatory Analysis and Development, 
PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 
20737-1238. Please state that your comment refers to Docket No. APHIS-
2007-0130.
    Reading Room: You may read any comments that we receive on this 
docket in our reading room. The reading room 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) or on the APHIS Web site at 
http://www.aphis.usda.gov/brs/aphisdocs/07_10801p.pdf, http://www.aphis.usda.gov/brs/aphisdocs/07_10801p _dea.pdf, and http://www.aphis.usda.gov/brs/aphisdocs/07_10801p _dpra.pdf.

FOR FURTHER INFORMATION CONTACT: Mr. Rick Coker, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-5720, e-mail: richard.s.coker@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 07-108-01p) 
from Syngenta Biotechnology, Inc. (Syngenta), seeking a determination 
of nonregulated status for cotton (Gossypium spp.) designated as 
COT67B, which has been genetically engineered to express a Cry1Ab 
protein to protect cotton plants from lepidopteran insect damage, 
stating that cotton event COT67B 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, COT67B cotton produces a full-length 
Cry1Ab protein originally derived from Bacillus thuringiensis subsp. 
kurstaki HD-1 which has activity against several important lepidopteran 
pest species of cotton. These include, but are not limited to, 
Helicoverpa zea (cotton bollworm), Heliothis virescens (tobacco 
budworm), Pectinophora gossypiella (pink bollworm), and Trichoplusia ni 
(cabbage looper). Cotton event COT67B is currently regulated under 7 
CFR part 340. Interstate movements and field tests of cotton event 
COT67B 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 data are used by APHIS to determine if the new 
variety poses a plant pest risk. Syngenta has petitioned APHIS to make 
a determination that cotton event COT67B should not be regulated under 
7 CFR part 340.
    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 cotton event COT67B 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 Syngenta, 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 cotton event COT67B and it would 
continue to be a regulated article, or (2) approve the petition based 
on a determination of the nonregulated status of cotton event COT67B in 
whole.
    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 nonregulated status for 
cotton event COT67B. 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 line. 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 as 
indicated under ADDRESSES above. 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 cotton event

[[Page 27303]]

COT67B 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 4th day of May 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-11519 Filed 5-10-11; 8:45 am]
BILLING CODE 3410-34-P
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