[Federal Register Volume 80, Number 12 (Tuesday, January 20, 2015)]
[Notices]
[Pages 2675-2676]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-00723]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2013-0043]


Monsanto Co.; Determination of Nonregulated Status of Herbicide 
Resistant Soybean and Cotton

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that soybean 
and cotton genetically engineered for herbicide resistance by the 
Monsanto Company are no longer considered regulated articles 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 two petitions for a 
determination of nonregulated status, our analysis of publically 
available scientific data, and comments received from the public on the 
petition for nonregulated status and its associated environmental 
impact statement and plant pest risk assessments. This notice also 
announces the availability of our written determination and record of 
decision.

DATES: Effective Date: January 20, 2015.

ADDRESSES: You may read the documents referenced in this notice and any 
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) 799-7039 before coming. Those 
documents are also available on the Internet at http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under 
APHIS Petition Numbers 10-188-01p (soybean) and 12-185-01p (cotton) and 
are posted with the comments we received on the Regulations.gov Web 
site at http://www.regulations.gov/#!docketDetail;D=APHIS-2013-0043.

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 documents referenced in this notice, 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 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 two petitions (referred to below as ``the 
petitions'') from the Monsanto Company seeking determinations of 
nonregulated status for soybean and cotton cultivars genetically 
engineered to be resistant to herbicides. The first petition, APHIS 
Petition Number 10-188-01p, seeks a determination of nonregulated 
status of soybean (Glycine max) designated as event MON 87708, which 
has been genetically engineered for tolerance to the herbicide dicamba. 
The second petition, APHIS Petition Number 12-185-01p, seeks a 
determination of nonregulated status of cotton (Gossypium spp.) 
designated as event MON 88701, which has been genetically engineered 
for tolerance to the herbicides dicamba and glufosinate. The petitions 
state that these articles are unlikely to pose a plant pest risk and, 
therefore, should not be regulated articles under APHIS' regulations in 
7 CFR part 340.
    Notices were published \1\ in the Federal Register for each 
petition advising the public that APHIS had received the petition and 
was seeking public comments on the petition. The notices also announced 
that APHIS would prepare either an environmental assessment or an 
environmental impact

[[Page 2676]]

statement (EIS) in accordance with the National Environmental Policy 
Act of 1969, as amended (42 U.S.C. 4321 et seq., NEPA) to provide the 
Agency with a review and analysis of any potential environmental 
impacts associated with the petition request.
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    \1\ Docket No. APHIS-2012-0047 published on July 13, 2012, 77 FR 
41356-41357; Docket No. APHIS-2012-0097 published on February 27, 
2013, 78 FR 13308-13309. The Federal Register notices for the 
petitions and supporting and related materials, including public 
comments, are available at http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0047 and http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0097.
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    Following review of public comments, we published another notice 
\2\ in the Federal Register on May 16, 2013 (78 FR 28796-28797, Docket 
No. APHIS-2013-0043), advising the public of our intent to prepare an 
EIS for the potential determination of nonregulated status requested by 
the petitions. APHIS decided to prepare an EIS in order to perform a 
comprehensive environmental analysis of the potential environmental 
impacts that may occur as a result of granting determinations of 
nonregulated status for these two events.
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    \2\ To view the notice the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2013-0043.
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National Environmental Policy Act and Record of Decision

    To provide the public with documentation of APHIS' review and 
analysis of the potential environmental impacts associated with a 
determination of nonregulated status of MON 87708 soybean and MON 
88701cotton, an EIS has been 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).
    A notice of availability regarding the draft EIS prepared by APHIS 
was published by the Environmental Protection Agency (EPA) in the 
Federal Register on August 11, 2014 (79 FR 46799, Docket No. ER-FRL-
9016-4). Along with the draft EIS,\3\ APHIS also made available the 
plant pest risk assessments (PPRAs) for the petitions. APHIS reviewed 
and evaluated all of the public comments received on the draft EIS and 
prepared formal responses to them as part of the final EIS.
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    \3\ To view the draft EIS, final EIS, supporting documents, and 
the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2013-0043.
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    A notice of availability regarding the final EIS prepared by APHIS 
was published by EPA in the Federal Register on December 12, 2014 (79 
FR 73890, Docket No. ER-FRL-9018-4). The NEPA implementing regulations 
in 40 CFR 1506.10 require a minimum 30-day review period between the 
time the notice of availability of a final EIS is published and the 
time an agency makes a decision on an action covered by the EIS. APHIS 
has reviewed and evaluated the comments received during the 30-day 
review period and has concluded that it has fully and appropriately 
analyzed the relevant environmental issues covered by the final EIS and 
those comments. Based on our final EIS, the response to public 
comments, and other pertinent scientific data, APHIS has prepared a 
record of decision for the final EIS.

Determination of Nonregulated Status

    Based on APHIS' analysis of field and laboratory data submitted by 
the Monsanto Company, references provided in the petitions, peer-
reviewed publications, information analyzed in the EIS, the PPRAs, 
comments provided by the public, and APHIS' evaluation of and response 
to those comments, APHIS has determined that MON 87708 soybean and MON 
88701 cotton are unlikely to pose a plant pest risk. Accordingly, the 
petitions requesting a determination of nonregulated status are 
approved and MON 87708 soybean and MON 88701 cotton are no longer 
subject to our regulations governing the introduction of certain 
genetically engineered organisms and to the plant pest provisions of 
the Plant Protection Act.
    Copies of the two signed determination document and the signed 
record of decision, as well as copies of the final EIS and two PPRAs 
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 13th day of January 2015.
Michael Gregoire,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-00723 Filed 1-16-15; 8:45 am]
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