80 FR 76260 - Monsanto Co.; Determination of Nonregulated Status of Maize Genetically Engineered for Increased Ear Biomass

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 235 (December 8, 2015)

Page Range		76260-76261
FR Document		2015-30877

We are advising the public of our determination that maize designated as event MON 87403, which has been genetically engineered for increased ear biomass, is no longer considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms. Our determination is based on our evaluation of data submitted by Monsanto Company in its petition for a determination of nonregulated status, our analysis of available scientific data, and comments received from the public in response to our previous notices announcing the availability of the petition for nonregulated status and its associated environmental assessment and plant pest risk assessment. This notice also announces the availability of our written determination and finding of no significant impact.

Federal Register, Volume 80 Issue 235 (Tuesday, December 8, 2015)

[Federal Register Volume 80, Number 235 (Tuesday, December 8, 2015)]
[Notices]
[Pages 76260-76261]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-30877]


========================================================================
Notices
                                                Federal Register
________________________________________________________________________

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 
appearing in this section.

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Federal Register / Vol. 80, No. 235 / Tuesday, December 8, 2015 / 
Notices

[[Page 76260]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2014-0097]


Monsanto Co.; Determination of Nonregulated Status of Maize 
Genetically Engineered for Increased Ear Biomass

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that maize 
designated as event MON 87403, which has been genetically engineered 
for increased ear biomass, is no longer considered a regulated article 
under our regulations governing the introduction of certain genetically 
engineered organisms. Our determination is based on our evaluation of 
data submitted by Monsanto Company in its petition for a determination 
of nonregulated status, our analysis of available scientific data, and 
comments received from the public in response to our previous notices 
announcing the availability of the petition for nonregulated status and 
its associated environmental assessment and plant pest risk assessment. 
This notice also announces the availability of our written 
determination and finding of no significant impact.

DATES: Effective December 8, 2015.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received at http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0097 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 are also available on the APHIS Web site at 
http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml 
under APHIS Petition Number 14-213-01p.

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: 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 
14-213-01p) from Monsanto Company (Monsanto) of St. Louis, MO, seeking 
a determination of nonregulated status of maize (Zea mays) designated 
as event MON 87403, which has been genetically engineered for increased 
ear biomass. The Monsanto petition states that information collected 
during field trials and laboratory analyses indicates that MON 87403 
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 January 20, 2015 (80 FR 2674-2675, Docket No. APHIS-2014-
0097), APHIS announced the availability of the Monsanto petition for 
public comment. APHIS solicited comments on the petition for 60 days 
ending on March 23, 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.
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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, other supporting 
documents, and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0097.
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    APHIS received 20 comments on the petition. Issues raised during 
the comment period include the contamination of conventional crop 
production, the potential for disruption of trade due to the presence 
of unwanted genetically engineered commodities in exports, the 
potential for negative impacts on plant fitness and the environment, 
and health concerns. APHIS decided, based on its review of the petition 
and its evaluation and analysis of the comments received during the 60-
day public comment period on the petition, that the petition involves a 
GE organism that raises substantive new issues. According to our public 
review process for such petitions (see footnote 1), APHIS is following 
Approach 2 where we first solicit written comments from the public on a 
draft environmental assessment (EA) and a preliminary plant pest risk 
assessment (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 preliminary PPRA and other 
information, APHIS revises the preliminary PPRA as necessary and 
prepares a final EA and, based on the final EA, a National 
Environmental Policy Act (NEPA) decision document (either a finding of 
no significant impact

[[Page 76261]]

(FONSI) or a notice of intent to prepare an environmental impact 
statement). If a FONSI is reached, APHIS furnishes a response to the 
petitioner, either approving or denying the petition. APHIS also 
publishes 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.
    APHIS sought public comment on a draft EA and a preliminary PPRA 
from July 21, 2015, to August 20, 2015.\3\ APHIS solicited comments on 
the draft EA, the preliminary PPRA, and whether the subject maize is 
likely to pose a plant pest risk. APHIS received 4 comments on the 
petition. One commenter supported a decision of nonregulated status for 
MON 87403 maize; two were opposed, and one was in support of 
nonregulated status but wanted APHIS to require continued oversight 
during the commercialization process. Issues raised during the comment 
period included concerns regarding general safety, potential for 
increased weediness, and the potential for gene flow to other corn 
varieties. APHIS has addressed the issues raised during the comment 
period and has provided responses to comments as an attachment to the 
FONSI. National Environmental Policy Act.
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    \3\ 80 FR 43053-43055.
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    After reviewing and evaluating the comments received during the 
comment period on the draft EA and preliminary PPRA and other 
information, APHIS has prepared a final EA. The EA has been prepared to 
provide the public with documentation of APHIS' review and analysis of 
any potential environmental impacts associated with the determination 
of nonregulated status of maize designated as event MON 87403. 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, 
the response to public comments, and other pertinent scientific data, 
APHIS has reached a FONSI with regard to the preferred alternative 
identified in the EA (to make a determination of nonregulated status of 
maize designated as event MON 87403).

Determination

    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, and information provided in APHIS' response to 
those public comments, APHIS has determined that maize designated as 
event MON 87403 is unlikely to pose a plant pest risk and therefore are 
no longer subject to our regulations governing the introduction of 
certain GE organisms.
    Copies of the signed determination document, PPRA, final EA, FONSI, 
and response to comments, as well as the previously published petition 
and supporting documents, are available as indicated in the ADDRESSES 
and FOR FURTHER INFORMATION CONTACT sections of this notice.

    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 2nd day of December 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-30877 Filed 12-7-15; 8:45 am]
 BILLING CODE 3410-34-P

76260

Notices Federal Register
Vol. 80, No. 235

Tuesday, December 8, 2015

This section of the FEDERAL REGISTER help you, please call (202) 7997039 considering petitions for determinations
contains documents other than rules or before coming. of nonregulated status of GE organisms,
proposed rules that are applicable to the Supporting documents are also APHIS accepts written comments
public. Notices of hearings and investigations, available on the APHIS Web site at regarding a petition once APHIS deems
committee meetings, agency decisions and http://www.aphis.usda.gov/ it complete. In a notice 2 published in
rulings, delegations of authority, filing of
biotechnology/petitions_table_ the Federal Register on January 20,
petitions and applications and agency
statements of organization and functions are pending.shtml under APHIS Petition 2015 (80 FR 2674–2675, Docket No.
examples of documents appearing in this Number 14–213–01p. APHIS–2014–0097), APHIS announced
section. FOR FURTHER INFORMATION CONTACT: Dr. the availability of the Monsanto petition
John Turner, Director, Environmental for public comment. APHIS solicited
Risk Analysis Programs, Biotechnology comments on the petition for 60 days
DEPARTMENT OF AGRICULTURE Regulatory Services, APHIS, 4700 River ending on March 23, 2015, in order to
Road Unit 147, Riverdale, MD 20737– help identify potential environmental
Animal and Plant Health Inspection 1236; (301) 851–3954, email: and interrelated economic issues and
Service john.t.turner@aphis.usda.gov. To obtain impacts that APHIS may determine
copies of the supporting documents for should be considered in our evaluation
[Docket No. APHIS–2014–0097] this petition, contact Ms. Cindy Eck at of the petition.
(301) 851–3892, email: cynthia.a.eck@ APHIS received 20 comments on the
Monsanto Co.; Determination of aphis.usda.gov. petition. Issues raised during the
Nonregulated Status of Maize comment period include the
SUPPLEMENTARY INFORMATION: The
Genetically Engineered for Increased contamination of conventional crop
Ear Biomass regulations in 7 CFR part 340,
‘‘Introduction of Organisms and production, the potential for disruption
Products Altered or Produced Through of trade due to the presence of
AGENCY: Animal and Plant Health
Genetic Engineering Which Are Plant unwanted genetically engineered
Inspection Service, USDA.
Pests or Which There Is Reason to commodities in exports, the potential
ACTION: Notice. for negative impacts on plant fitness and
Believe Are Plant Pests,’’ regulate,
among other things, the introduction the environment, and health concerns.
SUMMARY: We are advising the public of
(importation, interstate movement, or APHIS decided, based on its review of
our determination that maize designated
release into the environment) of the petition and its evaluation and
as event MON 87403, which has been
organisms and products altered or analysis of the comments received
genetically engineered for increased ear
produced through genetic engineering during the 60-day public comment
biomass, is no longer considered a
that are plant pests or that there is period on the petition, that the petition
regulated article under our regulations
reason to believe are plant pests. Such involves a GE organism that raises
governing the introduction of certain
genetically engineered (GE) organisms substantive new issues. According to
genetically engineered organisms. Our
and products are considered ‘‘regulated our public review process for such
determination is based on our
articles.’’ petitions (see footnote 1), APHIS is
evaluation of data submitted by
The regulations in § 340.6(a) provide following Approach 2 where we first
Monsanto Company in its petition for a
that any person may submit a petition solicit written comments from the
determination of nonregulated status,
to the Animal and Plant Health public on a draft environmental
our analysis of available scientific data,
Inspection Service (APHIS) seeking a assessment (EA) and a preliminary plant
and comments received from the public
determination that an article should not pest risk assessment (PPRA) for a 30-day
in response to our previous notices
be regulated under 7 CFR part 340. comment period through the
announcing the availability of the
APHIS received a petition (APHIS publication of a Federal Register notice.
petition for nonregulated status and its
Petition Number 14–213–01p) from Then, after reviewing and evaluating the
associated environmental assessment
Monsanto Company (Monsanto) of St. comments on the draft EA and the
and plant pest risk assessment. This
Louis, MO, seeking a determination of preliminary PPRA and other
notice also announces the availability of
nonregulated status of maize (Zea mays) information, APHIS revises the
our written determination and finding
designated as event MON 87403, which preliminary PPRA as necessary and
of no significant impact.
has been genetically engineered for prepares a final EA and, based on the
DATES: Effective December 8, 2015. final EA, a National Environmental
increased ear biomass. The Monsanto
ADDRESSES: You may read the petition states that information collected Policy Act (NEPA) decision document
documents referenced in this notice and during field trials and laboratory (either a finding of no significant impact
the comments we received at http:// analyses indicates that MON 87403
www.regulations.gov/ maize is not likely to be a plant pest and
APHIS–2011–0129) a notice describing our public
#!docketDetail;D=APHIS-2014-0097 or review process for soliciting public comments and
therefore should not be a regulated information when considering petitions for
Lhorne on DSK9F6TC42PROD with NOTICES

in our reading room, which is located in article under APHIS’ regulations in 7 determinations of nonregulated status for GE
room 1141 of the USDA South Building, CFR part 340. organisms. To view the notice, go to http://
14th Street and Independence Avenue According to our process 1 for www.regulations.gov/#!docketDetail;D=APHIS-
SW., Washington, DC. Normal reading 2011-0129.
soliciting public comment when 2 To view the notice, the petition, other
room hours are 8 a.m. to 4:30 p.m., supporting documents, and the comments we
Monday through Friday, except 1 On March 6, 2012, APHIS published in the received, go to http://www.regulations.gov/
holidays. To be sure someone is there to Federal Register (77 FR 13258–13260, Docket No. #!docketDetail;D=APHIS-2014-0097.

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Federal Register / Vol. 80, No. 235 / Tuesday, December 8, 2015 / Notices 76261

(FONSI) or a notice of intent to prepare references provided in the petition, DATES: We will consider all comments
an environmental impact statement). If peer-reviewed publications, information that we receive on or before January 7,
a FONSI is reached, APHIS furnishes a analyzed in the EA, the PPRA, 2016.
response to the petitioner, either comments provided by the public, and ADDRESSES: You may submit comments
approving or denying the petition. information provided in APHIS’ by either of the following methods:
APHIS also publishes a notice in the response to those public comments, • Federal eRulemaking Portal: Go to
Federal Register announcing the APHIS has determined that maize http://www.regulations.gov/
regulatory status of the GE organism and designated as event MON 87403 is #!docketDetail;D=APHIS-2015-0088.
the availability of APHIS’ final EA, unlikely to pose a plant pest risk and • Postal Mail/Commercial Delivery:
PPRA, FONSI, and our regulatory therefore are no longer subject to our Send your comment to Docket No.
determination. regulations governing the introduction APHIS–2015–0088, Regulatory Analysis
APHIS sought public comment on a of certain GE organisms. and Development, PPD, APHIS, Station
draft EA and a preliminary PPRA from Copies of the signed determination 3A–03.8, 4700 River Road Unit 118,
July 21, 2015, to August 20, 2015.3 document, PPRA, final EA, FONSI, and Riverdale, MD 20737–1238.
APHIS solicited comments on the draft response to comments, as well as the The J.R. Simplot Company extension
EA, the preliminary PPRA, and whether previously published petition and request, our preliminary finding of no
the subject maize is likely to pose a supporting documents, are available as significant impact, our similarity
plant pest risk. APHIS received 4 indicated in the ADDRESSES and FOR assessment, our preliminary
comments on the petition. One FURTHER INFORMATION CONTACT sections determination, and any comments we
commenter supported a decision of of this notice. receive on this docket may be viewed at
nonregulated status for MON 87403 Authority: 7 U.S.C. 7701–7772 and 7781– http://www.regulations.gov/
maize; two were opposed, and one was 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and #!docketDetail;D=APHIS-2015-0088 or
in support of nonregulated status but 371.3. in our reading room, which is located in
wanted APHIS to require continued Done in Washington, DC, this 2nd day of Room 1141 of the USDA South
oversight during the commercialization December 2015. Building, 14th Street and Independence
process. Issues raised during the Kevin Shea, Avenue SW., Washington, DC. Normal
comment period included concerns Administrator, Animal and Plant Health reading room hours are 8 a.m. to 4:30
regarding general safety, potential for Inspection Service. p.m., Monday through Friday, except
increased weediness, and the potential [FR Doc. 2015–30877 Filed 12–7–15; 8:45 am] holidays. To be sure someone is there to
for gene flow to other corn varieties. help you, please call (202) 799–7039
BILLING CODE 3410–34–P
APHIS has addressed the issues raised before coming.
during the comment period and has Supporting documents and any
provided responses to comments as an DEPARTMENT OF AGRICULTURE comments we received regarding our
attachment to the FONSI. National determination of nonregulated status of
Environmental Policy Act. Animal and Plant Health Inspection the antecedent organisms (InnateTM
After reviewing and evaluating the Service Potato events E12, F10, and J3), can be
comments received during the comment found at http://www.regulations.gov/
period on the draft EA and preliminary [Docket No. APHIS–2015–0088]
#!docketDetail;D=APHIS-2012-0067.
PPRA and other information, APHIS has Supporting documents may also be
J.R. Simplot Company; Availability of
prepared a final EA. The EA has been found on the APHIS Web site for V11
Preliminary Finding of No Significant
prepared to provide the public with potato (the organism under evaluation)
Impact, Similarity Assessment, and
documentation of APHIS’ review and under APHIS Petition Number 15–140–
Preliminary Decision for an Extension
analysis of any potential environmental 01p, and the antecedent organisms
of a Determination of Nonregulated
impacts associated with the (InnateTM Potato events E12, F10, and
Status to V11 Snowden Potatoes With
determination of nonregulated status of J3) under APHIS Petition Number 13–
Low Acrylamide Potential and
maize designated as event MON 87403. 022–01p.
Reduced Black Spot Bruise
The EA was prepared in accordance FOR FURTHER INFORMATION CONTACT: Dr.
with: (1) NEPA, as amended (42 U.S.C. AGENCY: Animal and Plant Health John Turner, Director, Environmental
4321 et seq.), (2) regulations of the Inspection Service, USDA. Risk Analysis Programs, Biotechnology
Council on Environmental Quality for ACTION: Notice. Regulatory Services, APHIS, 4700 River
implementing the procedural provisions Road Unit 147, Riverdale, MD 20737–
of NEPA (40 CFR parts 1500–1508), (3) SUMMARY: We are advising the public
that the Animal and Plant Health 1236; (301) 851–3954, email:
USDA regulations implementing NEPA john.t.turner@aphis.usda.gov. To obtain
(7 CFR part 1b), and (4) APHIS’ NEPA Inspection Service has reached a
preliminary decision to extend our copies of the supporting documents,
Implementing Procedures (7 CFR part contact Ms. Cindy Eck at (301) 851–
372). Based on our EA, the response to determination of nonregulated status of
InnateTM potato to Snowden potato 3885, email: cynthia.a.eck@
public comments, and other pertinent aphis.usda.gov.
scientific data, APHIS has reached a variety event SPS–00V11–6 (hereinafter
FONSI with regard to the preferred V11 potato) in response to a request SUPPLEMENTARY INFORMATION: Under the
alternative identified in the EA (to make from the J.R. Simplot Company. V11 authority of the plant pest provisions of
a determination of nonregulated status potato has been genetically engineered the Plant Protection Act (PPA) (7 U.S.C.
of maize designated as event MON to exhibit low acrylamide potential in 7701 et seq.), the regulations in 7 CFR
Lhorne on DSK9F6TC42PROD with NOTICES

87403). cooked potatoes and reduced black spot part 340, ‘‘Introduction of Organisms
bruise. We are making available for and Products Altered or Produced
Determination public comment our preliminary finding Through Genetic Engineering Which
Based on APHIS’ analysis of field and of no significant impact, our similarity Are Plant Pests or Which There Is
laboratory data submitted by Monsanto, assessment, and our preliminary Reason to Believe Are Plant Pests,’’
extended determination of nonregulated regulate, among other things, the
3 80 FR 43053–43055. status. introduction (importation, interstate

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Document Created: 2015-12-14 13:27:32
Document Modified: 2015-12-14 13:27:32

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Effective December 8, 2015.
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]
FR Citation		80 FR 76260

80 FR 76260 - Monsanto Co.; Determination of Nonregulated Status of Maize Genetically Engineered for Increased Ear Biomass

DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service

Federal Register Volume 80, Issue 235 (December 8, 2015)

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service