[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.
[[Page 20561]]
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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