[Federal Register Volume 79, Number 217 (Monday, November 10, 2014)]
[Notices]
[Pages 66686-66687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26597]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2013-0013]
Monsanto Company and Forage Genetics International; Determination
of Nonregulatory Status of Genetically Engineered Alfalfa
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public of our determination that an
alfalfa event developed by the Monsanto Company and Forage Genetics
International, designated as event KK179, which has been genetically
engineered to express reduced levels of guaiacyl lignin, 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 the
Monsanto Company and Forage Genetics International in its petition for
a determination of nonregulatory 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 November 10, 2014.
ADDRESSES: You may read the documents referenced in this notice and the
comments we received at http://www.regulations.gov/#!docketDetail;D=APHIS-2013-0013 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 12-321-01p.
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:
[[Page 66687]]
[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
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
12-321-01p) from the Monsanto Company and Forage Genetics International
(Monsanto and FGI), seeking a determination of nonregulated status of
alfalfa designated as event KK179, which has been genetically
engineered to express reduced levels of guaiacyl lignin, a major
subunit component of total lignin that slows the digestion of cellulose
in livestock, as compared to conventional alfalfa at the same stage of
growth. The petition states that this alfalfa 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 April 22, 2013, (78 FR 23738-23740, Docket No. APHIS-2013-
0013), APHIS announced the availability of the Monsanto and FGI
petition for public comment. APHIS solicited comments on the petition
for 60 days ending on June 21, 2013, 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, the comments we received,
and other supporting documents, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2013-0013.
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APHIS received 55 comments on the petition. APHIS decided, 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.
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 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 PPRA and other information, APHIS revises the 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.
In a notice (see footnote 2) published in the Federal Register on
May 30, 2014, (79 FR 31082-31083, Docket No. APHIS-2013-0013), APHIS
announced the availability of a draft EA and a PPRA for public comment.
APHIS solicited comments on the draft EA, the PPRA, and whether the
subject alfalfa is likely to pose a plant pest risk for 30 days ending
on June 30, 2014. During the comment period, APHIS received a total of
177 comments, of which, 13 were opposed to a determination of
nonregulated status and 164 were supportive of a determination of
nonregulated status. Issues raised include potential effects on human
health, effects from gene flow and effects on pollinators. APHIS has
addressed the issues raised during the comment period and has provided
responses to the comments as an attachment to the FONSI.
National Environmental Policy Act
After reviewing and evaluating the comments received during the
comment period on the draft EA and the 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 Monsanto and FGI's KK179 alfalfa. 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
KK179 alfalfa).
Determination
Based on APHIS' analysis of field and laboratory data submitted by
Monsanto and FGI, 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 Monsanto and FGI's
KK179 alfalfa is unlikely to pose a plant pest risk and therefore is 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 3rd day of November 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-26597 Filed 11-7-14; 8:45 am]
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