[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 80869-80870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-33011]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2011-0023]


Monsanto Co.; Determination of Nonregulated Status of Corn 
Genetically Engineered for Drought Tolerance

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 the Monsanto Co., designated as event MON 87460, 
which has been genetically engineered for drought tolerance, 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: December 27, 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-2011-0023.

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, 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 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 09-055-01p) from 
the Monsanto Company (Monsanto) of St. Louis, MO, seeking a 
determination of nonregulated status of corn (Zea mays L.) designated 
as event MON 87460, which has been genetically engineered for drought 
tolerance, stating that this corn 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 27303-27304, Docket No. APHIS-2011-0023), 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 corn is 
likely to pose a plant pest risk, the draft EA, and the PPRA for 60 
days ending on July 11, 2011. On July 27, 2011, APHIS published in the 
Federal Register (76 FR 44891-44892, Docket No. APHIS-2011-0023) a 
notice announcing the extension of the public comment period for 30 
days, ending on August 12, 2011.
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    \1\ To view the notices mentioned in this document, the 
petition, the draft EA, the PPRA, and the comments we received, go 
to http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0023.
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    APHIS received 250 comments through the Regulations.gov Web site 
during the comment period, with 21 commenters expressing support of the 
EA's preferred alternative to make a determination of nonregulated 
status and the remaining 229 commenters expressing opposition. Three of 
the submitted comments opposing a determination of nonregulated status 
included electronic attachments that consisted either of: (1) A single 
letter signed by numerous people (6,335 signatures), (2) many letters 
containing identical material (16,742 letters), or (3) a consolidated 
document of comments (22,500 comments). Many commenters generally 
expressed opposition to genetically engineered (GE) organisms

[[Page 80870]]

or crops but did not provide any specific disagreement with APHIS' 
analysis. Several commenters questioned the performance and drought-
tolerant capabilities of corn event MON 87460. Other issues raised by 
commenters include concerns regarding the adequacy of the analysis in 
the EA, effects of GE crops on biodiversity and organic agriculture, 
increased use of glyphosate, health and environmental effects of GE 
crops, and marketing and trade implications. APHIS has addressed the 
issues raised during the comment period and has provided responses to 
the 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 of Monsanto's corn event MON 
87460, 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 corn event 
MON 87460 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, 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 19th day of December 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-33011 Filed 12-22-11; 8:45 am]
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