[Federal Register Volume 76, Number 197 (Wednesday, October 12, 2011)]
[Notices]
[Pages 63279-63280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-26351]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2011-0038]


Monsanto Co.; Determination of Nonregulated Status for Soybean 
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 soybean 
line developed by the Monsanto Co., designated as event MON 87701, 
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 the 
Monsanto Company 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: October 12, 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-2011-0038.

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 09-082-01p) from 
the Monsanto Company (Monsanto) of St. Louis, MO, seeking a 
determination of nonregulated status for soybean (Glycine max) 
designated as event MON 87701, which has been genetically engineered 
for insect resistance, stating that this soybean 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 June 28, 2011 
(76 FR 37770-37771, Docket No. APHIS-2011-0038), APHIS announced the 
availability of the Monsanto petition, a plant pest risk assessment 
(PPRA), and a draft environmental assessment (EA) for public comment. 
APHIS solicited comments on the petition, whether the subject soybeans 
are likely to pose a plant pest risk, the draft EA, and the PPRA for 60 
days ending on August 29, 2011.
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    \1\ To view the notice, petition, draft EA, the PPRA, and the 
comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0038.
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    APHIS received four comments during the comment period. Two 
commenters referenced a different soybean line. One commenter expressed 
general opposition to genetically engineered crops but did not provide 
any specific comments on the petition, draft EA, or PPRA. One commenter 
suggested that APHIS should analyze the impacts of MON 87701 on bees 
and groundwater. APHIS has addressed the issues raised by this 
commenter in an attachment to the finding of no significant impact, and 
impacts to non-target insects and impacts on water are both addressed 
in the EA.

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 Monsanto's soybean event MON 
87701, 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 regard to the preferred alternative identified 
in the EA.

Determination

    Based on APHIS' analysis of field and laboratory data submitted by 
Monsanto, references provided in the petition, peer-reviewed 
publications, information analyzed in the EA, the PPRA, comments 
provided by the public, and information provided in APHIS' response to 
those public comments, APHIS has determined that Monsanto's

[[Page 63280]]

soybean event MON 87701 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, PPRA, 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 5th day of October 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-26351 Filed 10-11-11; 8:45 am]
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