[Federal Register Volume 75, Number 75 (Tuesday, April 20, 2010)]
[Notices]
[Pages 20560-20561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9198]



[[Page 20560]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2009-0072]


Syngenta Biotechnology, Inc.; Determination of Nonregulated 
Status for Corn Genetically Engineered for Insect Resistance

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 corn 
line developed by Syngenta Biotechnology, Inc., designated as 
transformation event MIR162, which has been genetically engineered for 
insect resistance, 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 other scientific 
data, and our response to comments received from the public on 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 of nonregulated status 
and finding of no significant impact.

EFFECTIVE DATE: April 20, 2010.

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/brs/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/fdmspublic/component/main?main=DocketDetail&d=APHIS-2009-0072).
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at (http://www.aphis.usda.gov).

FOR FURTHER INFORMATION CONTACT: Dr. Subray Hegde, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-0810, email: ([email protected]). To 
obtain copies of the documents referenced in this notice, contact Ms. 
Cindy Eck at (301) 734-0667, email: ([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 may be 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.
    On September 10, 2007, APHIS received a petition seeking a 
determination of nonregulated status (APHIS Petition Number 07-253-01p) 
from Syngenta Biotechnology, Inc., of Research Triangle Park, NC 
(Syngenta), for corn (Zea mays L.) designated as transformation event 
MIR162, which has been genetically engineered for insect resistance, 
stating that corn line MIR162 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 January 13, 
2010 (75 FR 1749-1751, Docket No. APHIS-2009-0072), APHIS announced the 
availability of Syngenta's petition and the associated draft 
environmental assessment (EA) and plant pest risk assessment for public 
comment. APHIS solicited comments for 60 days ending on March 15, 2010, 
on whether the genetically engineered corn is or could be a plant pest 
and on the EA and the risk assessment.
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    \1\ To view the notice, petition, EA, risk assessment, and the 
comments we received, go to (http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2009-0072).
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    APHIS received 35 comments during the comment period. There were 19 
comments from groups or individuals who supported deregulation and 13 
from those who opposed deregulation. 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 MIR162 corn, 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 that EA, 
the response to public comments, and other pertinent scientific data, 
APHIS has reached a finding of no significant impact with regard to the 
preferred alternative identified in the EA, i.e., that Syngenta's 
MIR162 corn line and lines developed from it should not result in any 
significant impacts once they are granted nonregulated status and are 
no longer regulated articles under its regulations in 7 CFR part 340.

Determination

    Based on APHIS' analysis of field, greenhouse, and laboratory data 
submitted by Syngenta, references provided in the petition, 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 MIR162 corn will 
not pose a plant pest risk and should be granted nonregulated status.
    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.

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    Done in Washington, DC, this 16\th\ day of April 2010.

Cindy J. Smith
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2010-9198 Filed 4-16-10; 4:15 pm]
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