[Federal Register Volume 78, Number 150 (Monday, August 5, 2013)]
[Notices]
[Pages 47272-47273]
From the Federal Register Online via the Government Publishing 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:
[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:
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]
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