[Federal Register Volume 79, Number 45 (Friday, March 7, 2014)]
[Notices]
[Pages 13035-13036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-04968]


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 Notices
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
 and investigations, committee meetings, agency decisions and rulings, 
 delegations of authority, filing of petitions and applications and agency 
 statements of organization and functions are examples of documents 
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  Federal Register / Vol. 79, No. 45 / Friday, March 7, 2014 / 
Notices  

[[Page 13035]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2014-0007]


Monsanto Co.; Availability of Petition for Determination of 
Nonregulated Status of Maize Genetically Engineered For Protection 
Against Corn Rootworm and Resistance to Glyphosate

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 received a petition from the Monsanto Company 
seeking a determination of nonregulated status of maize designated as 
event MON 87411, which has been genetically engineered for protection 
against corn rootworm and resistance to the herbicide glyphosate. 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 petition available for 
review and comment to help us identify potential environmental and 
interrelated economic issues and impacts that the Animal and Plant 
Health Inspection Service may determine should be considered in our 
evaluation of the petition.

DATES: We will consider all comments that we receive on or before May 
6, 2014.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/# !documentDetail;D=APHIS-2014-0007-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2014-0007, 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-2014-
0007 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/biotechnology/petitions_table_pending.shtml under 
APHIS petition number 13-290-01p.

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 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 13-290-01p) 
from the Monsanto Company (Monsanto) of St. Louis, MO, seeking a 
determination of nonregulated status of maize (Zea mays) designated as 
event MON 87411, which has been genetically engineered for protection 
against corn rootworm and resistance to the herbicide glyphosate. The 
Monsanto petition states that information collected during field trials 
and laboratory analyses indicates that MON 87411 maize is not likely to 
be a plant pest and therefore should not be a regulated article under 
APHIS' regulations in 7 CFR Part 340.
    As described in the petition, Monsanto developed MON 87411 maize by 
adding a suppression cassette that expresses an inverted repeat 
sequence designed to match the sequence of corn rootworm. The 
expression of the suppression cassette results in the formation of a 
double-stranded RNA (dsRNA) transcript containing the Snf7 gene. Upon 
consumption, the plant-produced dsRNA in MON 87411 results in corn 
rootworm mortality. MON 87411 maize also contains a cry3Bb1 gene that 
produces a modified Bacillus thuringiensis (subsp. kumamotoensis) 
Cry3Bb1 protein to protect against corn rootworm larval feeding. In 
addition, MON 87411 maize contains the cp4 epsps gene from 
Agrobacterium sp. strain CP4 that confers resistance to the herbicide 
glyphosate. MON 87411 maize is currently regulated under 7 CFR Part 
340. Interstate movements and field tests of MON 87411 maize 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 
the risk of persistence in the environment after completion of the 
tests. 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

[[Page 13036]]

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.
---------------------------------------------------------------------------

    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 comment, 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 corn 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 
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 involvement 
(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 28th day of February 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-04968 Filed 3-6-14; 8:45 am]
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