[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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]
BILLING CODE 3410-34-P