[Federal Register Volume 78, Number 143 (Thursday, July 25, 2013)]
[Notices]
[Pages 44924-44926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17933]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0035]


Monsanto Co.; Availability of Plant Pest Risk Assessment, 
Environmental Assessment, Preliminary Finding of No Significant Impact, 
and Preliminary Determination of Nonregulated Status of Canola 
Genetically Engineered for Herbicide Resistance

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 has prepared a preliminary determination regarding a 
request from the Monsanto Company seeking a determination of 
nonregulated status of canola designated as MON 88302, which has been 
genetically engineered for resistance to the herbicide glyphosate with 
more flexibility in the timing of herbicide application. We are also 
making available for public review our plant pest risk assessment, 
environmental assessment, and preliminary finding of no significant 
impact for the preliminary determination of nonregulated status.

DATES: We will consider any information that we receive on or before 
August 26, 2013.

ADDRESSES: You may submit any information by either of the following 
methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2012-0035.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2012-0035, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents for this petition and any other information we 
receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0035 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 for this petition are also available on the 
APHIS Web site at http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under APHIS Petition Number 11-188-01p.

FOR FURTHER INFORMATION CONTACT: Dr. Rebecca Stankiewicz Gabel, Chief, 
Biotechnology Environmental Analysis Branch, Environmental Risk 
Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River 
Road Unit 147, Riverdale, MD 20737-1236; (301) 851-3927, 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. APHIS received a petition (APHIS Petition Number 
11-188-01p) from the Monsanto Company (Monsanto) of St. Louis, MO, 
seeking a determination of nonregulated status of canola (Brassica 
napus) designated as event MON 88302,

[[Page 44925]]

which has been genetically engineered for resistance to the herbicide 
glyphosate with more flexibility in the timing of herbicide 
application. The petition stated that this canola 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 July 13, 2012, (77 FR 41357-41358, Docket No. APHIS-2012-
0035), APHIS announced the availability of the Monsanto petition for 
public comment. APHIS solicited comments on the petition for 60 days 
ending on September 11, 2012, 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, and the comments we 
received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-
2012-0035.
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    APHIS received 67 comments on the petition. Several of these 
comments included electronic attachments consisting of a document of 
identical or nearly identical letters, for a total of 4,670 comments on 
the petition. Issues raised during the comment period include effects 
of herbicide use, such as the development of herbicide-resistant weeds 
and effects on non-target organisms, gene flow, and effects on organic 
crop production. APHIS has evaluated the issues raised during the 
comment period and, where appropriate, has provided a discussion of 
these issues in our 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 decisionmaking process. According to our 
public review 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. For this petition, we are using Approach 1.
    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 substantive new issues, APHIS will follow Approach 
2. Under Approach 2, APHIS first solicits written comments from the 
public on a draft EA and 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 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).
    As part of our decisionmaking process regarding a GE organism's 
regulatory status, APHIS prepares a PPRA to assess the plant pest risk 
of the article. APHIS also prepares the appropriate environmental 
documentation--either an EA or an environmental impact statement--in 
accordance with NEPA, to provide the Agency and the public with a 
review and analysis of any potential environmental impacts that may 
result if the petition request is approved.
    APHIS has prepared a PPRA and has concluded that canola event MON 
88302 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 prepared an EA in which we present two alternatives based 
on our analysis of data submitted by Monsanto, 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 canola event MON 88302 and it would continue to be 
a regulated article, or (2) make a determination of nonregulated status 
of canola event MON 88302.
    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 and other pertinent scientific data, APHIS has reached 
a preliminary FONSI with regard to the preferred alternative identified 
in the EA.
    Based on APHIS' analysis of field and laboratory data submitted by 
Monsanto, references provided in the petition, peer-reviewed 
publications, information analyzed in the EA, the PPRA, comments 
provided by the public on the petition, and discussion of issues in the 
EA, APHIS has determined that canola event MON 88302 is unlikely to 
pose a plant pest risk. We have therefore reached a preliminary 
decision to make a determination of nonregulated status of canola event 
MON 88302, whereby canola event MON 88302 would no longer be subject to 
our regulations governing the introduction of certain GE organisms.
    We are making available for a 30-day review period APHIS' 
preliminary regulatory determination of canola event MON 88302, along 
with our PPRA, EA, and preliminary FONSI for the preliminary 
determination of nonregulated status. The EA, preliminary FONSI, PPRA, 
and our preliminary determination for canola event MON 88302, as well 
as the Monsanto petition and the comments received on the petition, are 
available as indicated under ADDRESSES and FOR FURTHER INFORMATION 
CONTACT above. Copies of these documents may also be obtained from the 
person listed under FOR FURTHER INFORMATION CONTACT.
    After the 30-day review period closes, APHIS will review and 
evaluate any information received during the 30-day review period. If, 
after evaluating the information received, APHIS determines that we 
have not received substantive new information that would warrant

[[Page 44926]]

APHIS altering our preliminary regulatory determination or FONSI, 
substantially changing the proposed action identified in the EA, or 
substantially changing the analysis of impacts in the EA, APHIS will 
notify the public through an announcement on our Web site of our final 
regulatory determination. If, however, APHIS determines that we have 
received substantive new information that would warrant APHIS altering 
our preliminary regulatory determination or FONSI, substantially 
changing the proposed action identified in the EA, or substantially 
changing the analysis of impacts in the EA, then APHIS will notify the 
public of our intent to conduct additional analysis and to prepare an 
amended EA, a new FONSI, and/or a revised PPRA, which would be made 
available for public review through the publication of a notice of 
availability in the Federal Register. APHIS will also notify the 
petitioner.

    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 19th day of July 2013.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-17933 Filed 7-24-13; 8:45 am]
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