[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)]
[Notices]
[Pages 8035-8037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03194]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2015-0048]


Monsanto Co.; Availability of a Preliminary Plant Pest Risk 
Assessment, Draft Environmental Assessment, Preliminary Finding of No 
Significant Impact, and Preliminary 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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[[Page 8036]]

SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has prepared a preliminary determination regarding a 
request from Monsanto Co. seeking a determination of nonregulated 
status for maize designated as event MON 87419, which has been 
genetically engineered for resistance to the herbicides dicamba and 
glufosinate. We are also making available for public review and comment 
our preliminary plant pest risk assessment, draft environmental 
assessment, and preliminary finding of no significant impact for the 
preliminary determination of nonregulated status.

DATES: We will consider all comments that we receive on or before March 
18, 2016.

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.
    Supporting documents for this 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) 7997039 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 15-113-01p.

FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director, 
Biotechnology 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: 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 
15-113-01p) from the Monsanto Company (Monsanto) of St. Louis, MO, 
seeking a determination of nonregulated status of 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 not likely to be 
a plant pest 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 August 13, 2015 (80 FR 48489-48490, Docket No. APHIS-2015-
0048), APHIS announced the availability of the Monsanto petition for 
public comment. APHIS solicited comments on the petition for 60 days 
ending on October 13, 2015, 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. 
APHIS received 21 comments on the petition, one of which included over 
23,000 signatures opposing the petition. APHIS has evaluated the issues 
raised during the comment period and, where appropriate, has provided a 
discussion of these issues in our draft environmental assessment (EA).
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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-
2015-0048.
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    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 draft EA, preliminary finding of no 
significant impact (FONSI), and its preliminary 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.
    Had APHIS decided, 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 would follow 
Approach 2. Under Approach 2, APHIS first solicits written comments 
from the public on a draft EA and preliminary 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 
preliminary PPRA and other information, APHIS would revise the 
preliminary 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.

[[Page 8037]]

    APHIS has prepared a preliminary PPRA and has concluded that maize 
designated as event MON 87419, which has been genetically engineered 
for resistance to the herbicides dicamba and glufosinate, 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 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 maize designated as event MON 87419, or 
(2) make a determination of nonregulated status of maize designated as 
event MON 87419.
    The draft 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 draft EA and other pertinent scientific data, 
APHIS has prepared a preliminary FONSI with regard to the preferred 
alternative identified in the draft 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 draft EA, the preliminary 
PPRA, comments provided by the public on the petition, and discussion 
of issues in the draft EA, APHIS has determined that maize designated 
as event MON 87419 is unlikely to pose a plant pest risk. We have 
therefore reached a decision to make a preliminary determination of 
nonregulated status of maize designated as event MON 87419, whereby 
maize designated as event MON 87419 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 maize designated as event MON 
87419, along with our preliminary PPRA, draft EA, and preliminary FONSI 
for the preliminary determination of nonregulated status. The draft EA, 
preliminary FONSI, preliminary PPRA, and our preliminary determination 
for maize designated as event MON 87419, 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 APHIS 
altering our preliminary regulatory determination or FONSI, 
substantially changing the proposed action identified in the draft EA, 
or substantially changing the analysis of impacts in the draft 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 draft EA, 
or substantially changing the analysis of impacts in the draft EA, then 
APHIS will conduct the additional analysis and prepare an amended EA, a 
new FONSI, and/or a revised PPRA, which would be made available for 
public review in a subsequent notice in the Federal Register, similar 
to an Approach 2 petition. 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 10th day of February 2016.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-03194 Filed 2-16-16; 8:45 am]
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