[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Notices]
[Pages 60448-60449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-25086]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2007-0130]


Syngenta Biotechnology, Inc.; 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 of our determination that a cotton 
line developed by Syngenta Biotechnology, Inc., designated as event 
COT67B, which has been genetically engineered to express a protein to 
protect cotton plants from lepidopteran insect damage, is no longer 
considered a regulated article under our regulations governing the 
introduction of certain genetically engineered organisms. Our 
determination is based on our evaluation of data submitted by Syngenta 
Biotechnology, Inc., in its petition for a determination of 
nonregulated status, our analysis of available scientific data, and 
comments received from the public in response to our previous notice 
announcing the availability of the petition for nonregulated status and 
its associated environmental assessment and plant pest risk assessment. 
This notice also announces the availability of our written 
determination and finding of no significant impact.

DATES: Effective Date: September 29, 2011.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received 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. Those 
documents are also available on the Internet at http://www.aphis.usda.gov/biotechnology/not_reg.html and are posted with the 
previous notice and the comments we received on the Regulations.gov Web 
site at http://www.regulations.gov/#!docketDetail;D=APHIS-2007-0130.

FOR FURTHER INFORMATION CONTACT: Mr. Evan Chestnut, Policy Analyst, 
Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, 
Riverdale, MD 20737-1236; (301) 734-0942, e-mail: 
[email protected]. To obtain copies of the documents 
referenced in this notice, contact Ms. Cindy Eck at (301) 734-0667, e-
mail: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    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 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 event 
COT67B, which has been genetically engineered to express a Cry1Ab 
protein to protect cotton plants from lepidopteran insect damage. The 
petition stated 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.
    In a notice \1\ published in the Federal Register on May 11, 2011 
(76 FR 27301-27303, Docket No. APHIS-2007-0130), APHIS announced the 
availability of the Syngenta petition, our plant pest risk assessment, 
and our draft environmental assessment (EA) for public comment. APHIS 
solicited comments on the petition, whether the subject cotton is 
likely to pose a plant pest risk, and on the draft EA for 60 days 
ending on July 11, 2011.
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    \1\ To view the notice, petition, draft EA, the plant pest risk 
assessment, and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2007-0130.
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    APHIS received 7 comments opposing a determination of nonregulated 
status during the comment period, with one comment having an additional 
4,045 names attached. Commenters generally expressed opposition to 
genetically engineered organisms or crops but did not provide any 
specific disagreement with APHIS' analysis. One commenter expressed 
concern with gene flow. APHIS has addressed the issues raised during 
the comment period and has provided responses to these comments as an 
attachment to the finding of no significant impact.

National Environmental Policy Act

    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with the 
determination of nonregulated status for Syngenta's cotton event 
COT67B, an EA has been prepared. The 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). Based on our EA, the response to public comments, and other 
pertinent scientific data, APHIS has reached a finding of no 
significant impact with

[[Page 60449]]

regard to the preferred alternative identified in the EA.

Determination

    Based on APHIS' analysis of field and laboratory data submitted by 
Syngenta, references provided in the petition, peer-reviewed 
publications, information analyzed in the EA, the plant pest risk 
assessment, comments provided by the public, and information provided 
in APHIS' response to those public comments, APHIS has determined that 
Syngenta's cotton event COT67B is unlikely to pose a plant pest risk 
and therefore is no longer subject to our regulations governing the 
introduction of certain genetically engineered organisms.
    Copies of the signed determination document, as well as copies of 
the petition, plant pest risk assessment, EA, finding of no significant 
impact, and response to comments are available as indicated in the 
ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of this notice.

    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 23rd day of September 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-25086 Filed 9-28-11; 8:45 am]
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