[Federal Register Volume 78, Number 216 (Thursday, November 7, 2013)]
[Notices]
[Pages 66891-66892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26703]



[[Page 66891]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0020]


Monsanto Co.; Determination of Nonregulated Status of Soybean 
Genetically Engineered for Increased Yield

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 
event developed by the Monsanto Company, designated as MON 87712, which 
has been genetically engineered for increased yield, 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 notices 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: November 7, 2013.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received at http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0020 or in our reading room, which 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) 799-7039 before coming.
    Supporting documents are also available on the APHIS Web site at 
http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml 
under APHIS Petition Number 11-202-01p.

FOR FURTHER INFORMATION CONTACT: Dr. Rebecca Stankiewicz Gabel, Chief, 
Biotechnology Environmental Analysis Branch, Environmental Risk 
Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River 
Road Unit 147, Riverdale, MD 20737-1236; (301) 851-3927, email: 
[email protected]. To obtain copies of the 
supporting documents for this petition, contact Ms. Cindy Eck at (301) 
851-3892, 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 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. APHIS received a petition (APHIS Petition Number 
11-202-01p) from the Monsanto Company (Monsanto) of St. Louis, MO, 
seeking a determination of nonregulated status of soybean (Glycine max) 
designated as MON 87712, which has been genetically engineered for 
increased yield. The petition states 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.
    According to our process \1\ for soliciting public comment when 
considering petitions for determinations of nonregulated status of 
genetically engineered (GE) organisms, APHIS accepts written comments 
regarding a petition once APHIS deems it complete. In a notice \2\ 
published in the Federal Register on July 13, 2012, (77 FR 41354-41355, 
Docket No. APHIS-2012-0020), APHIS announced the availability of the 
Monsanto petition for public comment. APHIS solicited comments on the 
petition for 60 days ending on September 11, 2012, in order to help 
identify potential environmental and interrelated economic issues and 
impacts that APHIS may determine should be considered in our evaluation 
of the petition.
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    \1\ On March 6, 2012, APHIS published in the Federal Register 
(77 FR 13258-13260, Docket No. APHIS-2011-0129) a notice describing 
our public review process for soliciting public comments and 
information when considering petitions for determinations of 
nonregulated status for GE organisms. To view the notice, go to 
http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
    \2\ To view the notice, the petition, the comments we received, 
and other supporting documents, go to  http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0020.
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    APHIS received 66 comments on the petition. Several of these 
comments included electronic attachments consisting of a consolidated 
document of many identical or nearly identical letters, for a total of 
4,665 comments. APHIS decided, based on its review of the petition and 
its evaluation and analysis of comments received during the 60-day 
public comment period on the petition, that the petition involves a GE 
organism that raises substantive new issues. According to our public 
review process for such petitions (see footnote 1), APHIS first 
solicits written comments from the public on a draft environmental 
assessment (EA) and plant pest risk assessment (PPRA) for a 30-day 
comment period through the publication of a Federal Register notice. 
Then, after reviewing and evaluating the comments on the draft EA and 
PPRA and other information, APHIS revises the PPRA as necessary and 
prepares a final EA and, based on the final EA, a National 
Environmental Policy Act (NEPA) decision document (either a finding of 
no significant impact (FONSI) or a notice of intent to prepare an 
environmental impact statement). If a FONSI is reached, APHIS furnishes 
a response to the petitioner, either approving or denying the petition. 
APHIS also publishes a notice in the Federal Register announcing the 
regulatory status of the GE organism and the availability of APHIS' 
final EA, PPRA, FONSI, and our regulatory determination.
    In a notice (see footnote 2) published in the Federal Register on 
August 5, 2013, (78 FR 47272-47273, Docket No. APHIS-2012-0020), APHIS 
announced the availability of a PPRA and a draft EA for public comment. 
APHIS solicited comments on the draft EA, the PPRA, and whether the 
subject soybeans are likely to pose a plant pest risk for 30 days 
ending on September 4, 2013. APHIS received one comment during the 
comment period. The comment did not address the regulatory status of 
MON 87712 soybean, but rather raised concerns regarding APHIS' 
authority to regulate GE plants and the Agency's NEPA process. APHIS 
has addressed the issues raised during the comment period and has 
provided responses to this comment as an attachment to the FONSI.

National Environmental Policy Act

    After reviewing and evaluating the comment received during the 
comment

[[Page 66892]]

period on the draft EA and PPRA and other information, APHIS has 
prepared a final EA. The EA has been prepared to provide the public 
with documentation of APHIS' review and analysis of any potential 
environmental impacts associated with the determination of nonregulated 
status of Monsanto's MON 87712 soybean. The EA was prepared in 
accordance with: (1) 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 FONSI with regard to the preferred alternative identified in 
the EA (to make a determination of nonregulated status of MON 87712 
soybean).

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 MON 87712 
soybean is unlikely to pose a plant pest risk and therefore is no 
longer subject to our regulations governing the introduction of certain 
GE organisms.
    Copies of the signed determination document, PPRA, final EA, FONSI, 
and response to comments, as well as the previously published petition 
and supporting documents, 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 1st day of November 2013.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-26703 Filed 11-6-13; 8:45 am]
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