[Federal Register Volume 79, Number 104 (Friday, May 30, 2014)]
[Notices]
[Pages 31082-31083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12553]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2013-0013]


Monsanto Company and Forage Genetics International; Availability 
of a Plant Pest Risk Assessment and Environmental Assessment 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 is making available for public comment our plant 
pest risk assessment and our draft environmental assessment regarding a 
request from the Monsanto Company and Forage Genetics International 
seeking a determination of nonregulated status of alfalfa designated as 
event KK179, which has been genetically engineered to express reduced 
levels of guaiacyl lignin. We are soliciting comments on whether this 
genetically engineered alfalfa is likely to pose a plant pest risk.

DATES: We will consider all comments that we receive on or before June 
30, 2014.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2013-0013.
     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.
    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: [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: 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 12-321-01p) from the Monsanto Company and Forage Genetics 
International 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 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.
    According to our process \1\ for soliciting public input when

[[Page 31083]]

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 Company and 
Forage Genetics International 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 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-
2013-0013.
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    APHIS received 55 comments on the petition. Issues raised during 
the comment period included concerns regarding potential impacts on 
human and animal health and nontarget organisms, herbicide use changes, 
and herbicide-resistant weeds. APHIS has evaluated the issues raised 
during the comment period and, where appropriate, has provided a 
discussion of those issues in our draft 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 decision-making process. According to our 
public input 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.
    Alternatively, 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 new crop-trait GE organism or 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 a 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 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 alfalfa event KK179 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 the Monsanto 
Company and Forage Genetics International, 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 alfalfa event KK179 and it would continue to be a 
regulated article, or (2) make a determination of nonregulated status 
of alfalfa event KK179. APHIS' preferred alternative is to make a 
determination of nonregulatory status of alfalfa event KK179.
    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 of GE 
organisms, we are publishing this notice to inform the public that 
APHIS will accept written comments on our draft EA and our PPRA 
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. Copies of the draft EA and the PPRA, as well as the 
previously published petition, are available as indicated in the 
ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of this notice.
    As indicated previously, 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 the 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 23rd day of May 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-12553 Filed 5-29-14; 8:45 am]
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