[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

[[Page 23740]]

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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