[Federal Register Volume 78, Number 77 (Monday, April 22, 2013)]
[Notices]
[Pages 23738-23740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-09384]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2013-0013]
Monsanto Company and Forage Genetics International (FGI);
Availability of Petition for Determination of Nonregulated 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 that the Animal and Plant Health
Inspection Service (APHIS) has received a petition from the Monsanto
Company and Forage Genetics International (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. The petition has been submitted in accordance with our
regulations concerning the introduction of certain genetically
engineered organisms and products. We are making the Monsanto Company
and FGI petition available for review and comment to help us identify
potential environmental and interrelated economic issues and impacts
that APHIS may determine should be considered in our evaluation of the
petition.
DATES: We will consider all comments that we receive on or before June
21, 2013.
[[Page 23739]]
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2013-0013-0001.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2013-0013, 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-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.
The petition is also available on the APHIS Web site at http://www.aphis.usda.gov/brs/aphisdocs/12_32101p.pdf.
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 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. 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 has received a petition (APHIS Petition Number 12-321-01p)
from the Monsanto Company and Forage Genetics International (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 (G lignin), a major subunit component of
total lignin, as compared to conventional alfalfa at the same stage of
growth. This reduction in G lignin leads to reduced accumulation of
total lignin in alfalfa forage, the principal feed product derived from
alfalfa. The petition states that this alfalfa event is unlikely to
pose a plant pest risk and, therefore, should not be a regulated
article under APHIS' regulations in 7 CFR part 340.
As described in the petition, the Monsanto Company and FGI have
developed event KK179 (Medicago sativa L.) for reduced levels of G
lignin through the suppression of caffeoyl CoA 3-O-methyltransferase
(CCOMT), a key enzyme in the lignin biosynthetic pathway. Event KK179
was produced by insertion of CCOMT gene segments, derived from alfalfa,
assembled to form an inverted repeat DNA sequence. The inverted repeat
sequence produces double-stranded RNA which suppresses endogenous CCOMT
gene expression via the RNA interference pathway. Suppression of the
CCOMT gene expression leads to lower CCOMT protein expression resulting
in reduced synthesis of G lignin subunit compared to conventional
alfalfa at the same stage of growth. The reduction in G lignin subunit
synthesis leads to reduced accumulation of total lignin, measured as
acid detergent lignin. Event KK179 is currently regulated under 7 CFR
part 340. Interstate movement and field tests of event KK179 have been
conducted under notifications acknowledged by APHIS.
Field tests conducted under APHIS oversight allowed for evaluation
in a natural agricultural setting while imposing measures to minimize
risk of persistence in the environment after completion of the test.
Data are gathered on multiple parameters and used by the applicant to
evaluate agronomic characteristics and product performance. These and
other data are used by APHIS to determine if the new variety poses a
plant pest risk.
Paragraph (d) of Sec. 340.6 provides that APHIS will publish a
notice in the Federal Register providing 60 days for public comment for
petitions for a determination of nonregulated status. On March 6, 2012,
we published in the Federal Register (77 FR 13258-13260, Docket No.
APHIS-2011-0129) a notice \1\ describing our process for soliciting
public comment when considering petitions for determinations of
nonregulated status for GE organisms. In that notice we indicated that
APHIS would accept written comments regarding a petition once APHIS
deemed it complete.
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\1\ To view the notice, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
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In accordance with Sec. 340.6(d) of the regulations and 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 regarding the petition for a determination of
nonregulated status from interested or affected persons for a period of
60 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.
We are interested in receiving comments regarding potential
environmental and interrelated economic issues and impacts that APHIS
may determine should be considered in our evaluation of the petition.
We are particularly interested in receiving comments regarding
biological, cultural, or ecological issues, and we encourage the
submission of scientific data, studies, or research to support your
comments. We also request that, when possible, commenters provide
relevant information regarding specific localities or regions as
alfalfa growth, crop management, and crop utilization may vary
considerably by geographic region.
After the comment period closes, APHIS will review all written
comments received during the comment period and any other relevant
information; any substantive issues identified by APHIS based on our
review of the petition and our evaluation and analysis of comments will
be considered in the development of our decisionmaking documents.
As part of our decisionmaking process regarding a GE organism's
regulatory status, APHIS prepares a plant pest risk assessment to
assess its plant pest risk and the appropriate environmental
documentation--either an environmental assessment (EA) or an
environmental impact statement (EIS)--in accordance with the National
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Environmental Policy Act (NEPA), to provide the Agency with a review
and analysis of any potential environmental impacts associated with the
petition request. For petitions for which APHIS prepares an EA, APHIS
will follow our published process for soliciting public comment (see
footnote 1) and publish a separate notice in the Federal Register
announcing the availability of APHIS' EA and plant pest risk
assessment. Should APHIS determine that an EIS is necessary, APHIS will
complete the NEPA EIS process in accordance with Council on
Environmental Quality regulations (40 CFR part 1500-1508) and APHIS'
NEPA implementing regulations (7 CFR part 372).
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 17th day of April 2013.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-09384 Filed 4-19-13; 8:45 am]
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