80 FR 76260 - Monsanto Co.; Determination of Nonregulated Status of Maize Genetically Engineered for Increased Ear Biomass

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 235 (December 8, 2015)

We are advising the public of our determination that maize designated as event MON 87403, which has been genetically engineered for increased ear biomass, 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.

[Federal Register Volume 80, Number 235 (Tuesday, December 8, 2015)]
[Notices]
[Pages 76260-76261]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-30877]


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Notices
                                                Federal Register
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This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
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Federal Register / Vol. 80, No. 235 / Tuesday, December 8, 2015 / 
Notices

[[Page 76260]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2014-0097]


Monsanto Co.; Determination of Nonregulated Status of Maize 
Genetically Engineered for Increased Ear Biomass

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 87403, which has been genetically engineered 
for increased ear biomass, 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 December 8, 2015.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received at http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0097 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) 7997039 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 14-213-01p.

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 
14-213-01p) from Monsanto Company (Monsanto) of St. Louis, MO, seeking 
a determination of nonregulated status of maize (Zea mays) designated 
as event MON 87403, which has been genetically engineered for increased 
ear biomass. The Monsanto petition states that information collected 
during field trials and laboratory analyses indicates that MON 87403 
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 January 20, 2015 (80 FR 2674-2675, Docket No. APHIS-2014-
0097), APHIS announced the availability of the Monsanto petition for 
public comment. APHIS solicited comments on the petition for 60 days 
ending on March 23, 2015, 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-2014-0097.
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    APHIS received 20 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 on 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 is following 
Approach 2 where we first solicit 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

[[Page 76261]]

(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.
    APHIS sought public comment on a draft EA and a preliminary PPRA 
from July 21, 2015, to August 20, 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 4 comments on the 
petition. One commenter supported a decision of nonregulated status for 
MON 87403 maize; two were opposed, and one was in support of 
nonregulated status but wanted APHIS to require continued oversight 
during the commercialization process. Issues raised during the comment 
period included concerns regarding general safety, potential for 
increased weediness, and the potential for gene flow to other corn 
varieties. APHIS has addressed the issues raised during the comment 
period and has provided responses to comments as an attachment to the 
FONSI. National Environmental Policy Act.
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    \3\ 80 FR 43053-43055.
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    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 87403. 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 87403).

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 87403 is 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.

    Done in Washington, DC, this 2nd day of December 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-30877 Filed 12-7-15; 8:45 am]
 BILLING CODE 3410-34-P