80 FR 48489 - Monsanto Company; Availability of Petition for Determination of Nonregulated Status for Maize Genetically Engineered for Resistance to Dicamba and Glufosinate

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 156 (August 13, 2015)

We are advising the public that the Animal and Plant Health Inspection Service (APHIS) has received a petition from the Monsanto Company (Monsanto) seeking a determination of nonregulated status for maize designated as MON 87419, which has been genetically engineered for resistance to the herbicides dicamba and glufosinate. 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 petition available for review and comment to help us identify potential issues and impacts that APHIS should be considering in our evaluation of the petition.

[Federal Register Volume 80, Number 156 (Thursday, August 13, 2015)]
[Notices]
[Pages 48489-48490]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-19925]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2015-0048]


Monsanto Company; Availability of Petition for Determination of 
Nonregulated Status for Maize Genetically Engineered for Resistance to 
Dicamba and Glufosinate

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 (Monsanto) seeking a determination of nonregulated status for 
maize designated as MON 87419, which has been genetically engineered 
for resistance to the herbicides dicamba and glufosinate. 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 petition available for review and comment to 
help us identify potential issues and impacts that APHIS should be 
considering in our evaluation of the petition.

DATES: We will consider all comments that we receive on or before 
October 13, 2015.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0048.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2015-0048, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    The petition and any comments we receive on this docket may be 
viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0048 
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 15-113-01p, or by contacting Ms. Cindy Eck at 
(301) 851-3892; email: [email protected].

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].

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. 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 15-113-01p) 
from the Monsanto Company (Monsanto) of St. Louis, MO, seeking a 
determination of nonregulated status for maize (Zea mays) designated as 
event MON 87419 which has been genetically engineered for resistance to 
the herbicides dicamba and glufosinate. The Monsanto petition states 
that information collected during field trials and laboratory analyses 
indicates that MON 87419 maize is unlikely to pose a plant pest risk 
and, therefore, should not be a regulated article under APHIS' 
regulations in 7 CFR part 340.
    MON 87419 maize is currently regulated under 7 CFR part 340. 
Interstate movements and field tests of MON 87419 maize have been 
authorized 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 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 comment, and copies are available as indicated under 
ADDRESSES 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 maize 
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.

[[Page 48490]]

    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 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 parts 1500 through 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 10th day of August 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-19925 Filed 8-12-15; 8:45 am]
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