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[Federal Register Volume 78, Number 150 (Monday, August 5, 2013)]
[Notices]
[Pages 47272-47273]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18876]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0020]

Monsanto Co.; Availability of Plant Pest Risk Assessment and 
Environmental Assessment for 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 that the Animal and Plant Health 
Inspection Service is making available for public comment our plant 
pest risk assessment and our draft environmental assessment regarding a 
request from the Monsanto Company seeking a determination of 
nonregulated status of soybean designated as MON 87712, which has been 
genetically engineered for increased yield. We are soliciting comments 
on whether this genetically engineered soybean is likely to pose a 
plant pest risk.

DATES: We will consider all comments that we receive on or before 
September 4, 2013.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2012-0020.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2012-0020, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed 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: 
rebecca.l.stankiewicz-gabel@aphis.usda.gov. To obtain copies of the 
supporting documents for this petition, contact Ms. Cindy Eck at (301) 
851-3892, email: cynthia.a.eck@aphis.usda.gov.

SUPPLEMENTARY INFORMATION:

Background

    Under the authority of the plant pest provisions of the Plant 
Protection Act (7 U.S.C. 7701 et seq.), 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 has 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 event MON 87712, which has been genetically 
engineered for increased yield. The petition stated 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 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,

[[Page 47273]]

(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, and the comments we 
received, 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. Issues raised during the comment period include effects 
on plant and animal diversity, soybean supply and prices, and organic 
soy production; gene flow; and food and feed impacts. APHIS has 
evaluated the issues raised during the comment period and, where 
appropriate, has provided a discussion of these issues in our 
environmental assessment (EA).
    After public comments are received on a completed petition, APHIS 
evaluates those comments and then provides a second opportunity for 
public involvement in our decisionmaking process. According to our 
public review process (see footnote 1), the second opportunity for 
public involvement follows one of two approaches, as described below.
    If APHIS decides, 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 no substantive new issues, APHIS will follow 
Approach 1 for public involvement. Under Approach 1, APHIS announces in 
the Federal Register the availability of APHIS' preliminary regulatory 
determination along with its EA, preliminary finding of no significant 
impact (FONSI), and its plant pest risk assessment (PPRA) for a 30-day 
public review period. APHIS will evaluate any information received 
related to the petition and its supporting documents during the 30-day 
public review period.
    If APHIS decides, 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, APHIS will follow Approach 
2. Under Approach 2, APHIS first solicits written comments from the 
public on a draft EA and 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 will revise the PPRA as necessary and prepare a final EA and, 
based on the final EA, a National Environmental Policy Act (NEPA) 
decision document (either a FONSI or a notice of intent to prepare an 
environmental impact statement). For this petition, we are using 
Approach 2.
    APHIS has prepared a PPRA to determine if soybean event MON 87712 
is unlikely to pose a plant pest risk. In section 403 of the Plant 
Protection Act, ``plant pest'' is defined as any living stage of any of 
the following that can directly or indirectly injure, cause damage to, 
or cause disease in any plant or plant product: A protozoan, a nonhuman 
animal, a parasitic plant, a bacterium, a fungus, a virus or viroid, an 
infectious agent or other pathogen, or any article similar to or allied 
with any of the foregoing.
    APHIS has also prepared a draft EA in which we present two 
alternatives based on our analysis of data submitted by Monsanto, a 
review of other scientific data, field tests conducted under APHIS 
oversight, and comments received on the petition. APHIS is considering 
the following alternatives: (1) Take no action, i.e., APHIS would not 
change the regulatory status of soybean event MON 87712 and it would 
continue to be a regulated article, or (2) make a determination of 
nonregulated status of soybean event MON 87712.
    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).
    In accordance with our process for soliciting public input when 
considering petitions for determinations of nonregulated status for GE 
organisms, we are publishing this notice to inform the public that 
APHIS will accept written comments on our PPRA and draft EA regarding 
the petition for a determination of nonregulated status from interested 
or affected persons for a period of 30 days from the date of this 
notice. The petition is available for public review, and copies are 
available as indicated under ADDRESSES and FOR FURTHER INFORMATION 
CONTACT above.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. After reviewing and evaluating the comments on the draft 
EA and PPRA and other information, APHIS will revise the PPRA as 
necessary and prepare a final EA. Based on the final EA, APHIS will 
prepare a NEPA decision document (either a FONSI or a notice of intent 
to prepare an environmental impact statement). If a FONSI is reached, 
APHIS will furnish a response to the petitioner, either approving or 
denying the petition. APHIS will also publish 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.

    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 31st day of July 2013.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-18876 Filed 8-2-13; 8:45 am]
BILLING CODE 3410-34-P
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