[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Notices]
[Pages 65689-65690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27284]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2014-0007]


Monsanto Co.; Determination of Nonregulated Status of Maize 
Genetically Engineered For Protection Against Corn Rootworm and 
Resistance to Glyphosate

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that maize 
designated as event MON 87411, which has been genetically engineered 
for protection against corn rootworm and resistance to the herbicide 
glyphosate, 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 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 October 27, 2015.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received at http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0007 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 13-290-01p.

FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director, 
Environmental Risk Analysis Programs, Biotechnology Regulatory 
Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737-1236; 
(301) 851-3954, 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: 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 (GE) 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 
13-290-01p) from Monsanto Company (Monsanto) of St. Louis, MO, seeking 
a determination of nonregulated status of maize (Zea mays) designated 
as event MON 87411, which has been genetically engineered for 
protection against corn rootworm and resistance to the herbicide 
glyphosate. The Monsanto petition states that information collected 
during field trials and laboratory analyses indicates that MON 87411 
maize is not likely to be a plant pest 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 GE 
organisms, APHIS accepts written comments regarding a petition once 
APHIS deems it complete. In a notice \2\ published in the Federal 
Register on March 7, 2014 (79 FR 13035-13036, Docket No. APHIS-2014-
0007), APHIS announced the availability of the Monsanto petition for 
public comment. APHIS solicited comments on the petition for 60 days 
ending on May 6, 2014, 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, other supporting 
documents, and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0007.
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    APHIS received 423 comments on the petition. Issues raised during 
the comment period include the contamination of conventional crop 
production, the potential for disruption of trade due to the presence 
of unwanted genetically engineered commodities in exports, the 
potential for negative impacts to plant fitness and the environment, 
and health concerns. APHIS decided, based on its review of the petition 
and its evaluation and analysis of the 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 a preliminary 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 the preliminary PPRA and other information, APHIS revises the 
preliminary 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.

[[Page 65690]]

    APHIS sought public comment on a draft EA and a preliminary PPRA 
from June 1, 2015, to July 1, 2015.\3\ APHIS solicited comments on the 
draft EA, the preliminary PPRA, and whether the subject maize is likely 
to pose a plant pest risk. APHIS received 12 comments on the petition; 
one of these comments had 67 documents and published articles appended 
to it. The majority of comments expressed general opposition to APHIS 
making a determination of nonregulated status of GE organisms. Issues 
raised during the comment period included concerns regarding negative 
economic impacts to farmers, potential health and environmental 
impacts, inadequate or outdated data, and the possibility for insects 
to develop insecticide resistance. APHIS has addressed the issues 
raised during the comment period and has provided responses to comments 
as an attachment to the FONSI.
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    \3\ 80 FR 30997-30998.
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National Environmental Policy Act

    After reviewing and evaluating the comments received during the 
comment period on the draft EA and preliminary 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 maize designated as event MON 87411. 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 
maize designated as event MON 87411).

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 maize designated as 
event MON 87411 are unlikely to pose a plant pest risk and therefore 
are 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.

Michael C. Gregoire,
Associate Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-27284 Filed 10-26-15; 8:45 am]
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