80 FR 65689 - Monsanto Co.; Determination of Nonregulated Status of Maize Genetically Engineered For Protection Against Corn Rootworm and Resistance to Glyphosate

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 207 (October 27, 2015)

Page Range		65689-65690
FR Document		2015-27284

We are advising the public of our determination that maize designated as event MON 87411, which has been genetically engineered for protection against corn rootworm and resistance to the herbicide glyphosate, 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 207 (Tuesday, October 27, 2015)

[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Notices]
[Pages 65689-65690]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27284]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2014-0007]


Monsanto Co.; 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 of our determination that maize 
designated as event MON 87411, which has been genetically engineered 
for protection against corn rootworm and resistance to the herbicide 
glyphosate, 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 October 27, 2015.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received at http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0007 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.
    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 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 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 
13-290-01p) from 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.
    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 March 7, 2014 (79 FR 13035-13036, Docket No. APHIS-2014-
0007), APHIS announced the availability of the Monsanto petition for 
public comment. APHIS solicited comments on the petition for 60 days 
ending on May 6, 2014, 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-2014-0007.
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    APHIS received 423 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 to 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 first 
solicits 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 (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.

[[Page 65690]]

    APHIS sought public comment on a draft EA and a preliminary PPRA 
from June 1, 2015, to July 1, 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 12 comments on the petition; 
one of these comments had 67 documents and published articles appended 
to it. The majority of comments expressed general opposition to APHIS 
making a determination of nonregulated status of GE organisms. Issues 
raised during the comment period included concerns regarding negative 
economic impacts to farmers, potential health and environmental 
impacts, inadequate or outdated data, and the possibility for insects 
to develop insecticide resistance. APHIS has addressed the issues 
raised during the comment period and has provided responses to comments 
as an attachment to the FONSI.
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    \3\ 80 FR 30997-30998.
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National Environmental Policy Act

    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 87411. 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 87411).

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 87411 are 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.

Michael C. Gregoire,
Associate Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-27284 Filed 10-26-15; 8:45 am]
BILLING CODE 3410-34-P

Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Notices 65689

our final regulatory determination. No holidays. To be sure someone is there to considering petitions for determinations
further Federal Register notice will be help you, please call (202) 799–7039 of nonregulated status of GE organisms,
published announcing the final before coming. APHIS accepts written comments
regulatory determination regarding Supporting documents are also regarding a petition once APHIS deems
MZHG0JG corn. available on the APHIS Web site at it complete. In a notice 2 published in
Authority: 7 U.S.C. 7701–7772 and 7781– http://www.aphis.usda.gov/ the Federal Register on March 7, 2014
7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and biotechnology/petitions_table_ (79 FR 13035–13036, Docket No.
371.3. pending.shtml under APHIS Petition APHIS–2014–0007), APHIS announced
Done in Washington, DC, this 22nd day of
Number 13–290–01p. the availability of the Monsanto petition
October. FOR FURTHER INFORMATION CONTACT: Dr. for public comment. APHIS solicited
Michael C. Gregoire, John Turner, Director, Environmental comments on the petition for 60 days
Risk Analysis Programs, Biotechnology ending on May 6, 2014, in order to help
Associate Administrator, Animal and Plant
Health Inspection Service. Regulatory Services, APHIS, 4700 River identify potential environmental and
Road, Unit 147, Riverdale, MD 20737– interrelated economic issues and
[FR Doc. 2015–27296 Filed 10–26–15; 8:45 am]
1236; (301) 851–3954, email: impacts that APHIS may determine
BILLING CODE 3410–34–P
john.t.turner@aphis.usda.gov. To obtain should be considered in our evaluation
copies of the supporting documents for of the petition.
DEPARTMENT OF AGRICULTURE this petition, contact Ms. Cindy Eck at APHIS received 423 comments on the
(301) 851–3892, email: cynthia.a.eck@ petition. Issues raised during the
Animal and Plant Health Inspection aphis.usda.gov. comment period include the
Service contamination of conventional crop
SUPPLEMENTARY INFORMATION: The
production, the potential for disruption
[Docket No. APHIS–2014–0007] regulations in 7 CFR part 340,
of trade due to the presence of
‘‘Introduction of Organisms and
unwanted genetically engineered
Monsanto Co.; Determination of Products Altered or Produced Through
commodities in exports, the potential
Nonregulated Status of Maize Genetic Engineering Which Are Plant
for negative impacts to plant fitness and
Genetically Engineered For Protection Pests or Which There Is Reason to
the environment, and health concerns.
Against Corn Rootworm and Believe Are Plant Pests,’’ regulate,
APHIS decided, based on its review of
Resistance to Glyphosate among other things, the introduction
the petition and its evaluation and
(importation, interstate movement, or
AGENCY: Animal and Plant Health analysis of the comments received
release into the environment) of
Inspection Service, USDA. during the 60-day public comment
organisms and products altered or
ACTION: Notice. period on the petition, that the petition
produced through genetic engineering
involves a GE organism that raises
SUMMARY: We are advising the public of that are plant pests or that there is
substantive new issues. According to
our determination that maize designated reason to believe are plant pests. Such
our public review process for such
as event MON 87411, which has been genetically engineered (GE) organisms
petitions (see footnote 1), APHIS first
genetically engineered for protection and products are considered ‘‘regulated
solicits written comments from the
against corn rootworm and resistance to articles.’’
public on a draft environmental
the herbicide glyphosate, is no longer The regulations in § 340.6(a) provide
assessment (EA) and a preliminary plant
considered a regulated article under our that any person may submit a petition
pest risk assessment (PPRA) for a 30-day
regulations governing the introduction to the Animal and Plant Health
comment period through the
of certain genetically engineered Inspection Service (APHIS) seeking a
publication of a Federal Register notice.
organisms. Our determination is based determination that an article should not
Then, after reviewing and evaluating the
on our evaluation of data submitted by be regulated under 7 CFR part 340.
comments on the draft EA and the
Monsanto Company in its petition for a APHIS received a petition (APHIS
preliminary PPRA and other
determination of nonregulated status, Petition Number 13–290–01p) from
information, APHIS revises the
our analysis of available scientific data, Monsanto Company (Monsanto) of St.
preliminary PPRA as necessary and
and comments received from the public Louis, MO, seeking a determination of
prepares a final EA and, based on the
in response to our previous notices nonregulated status of maize (Zea mays)
final EA, a National Environmental
announcing the availability of the designated as event MON 87411, which
Policy Act (NEPA) decision document
petition for nonregulated status and its has been genetically engineered for
(either a finding of no significant impact
associated environmental assessment protection against corn rootworm and
(FONSI) or a notice of intent to prepare
and plant pest risk assessment. This resistance to the herbicide glyphosate.
an environmental impact statement). If
notice also announces the availability of The Monsanto petition states that
a FONSI is reached, APHIS furnishes a
our written determination and finding information collected during field trials
response to the petitioner, either
of no significant impact. and laboratory analyses indicates that
approving or denying the petition.
MON 87411 maize is not likely to be a
DATES: Effective October 27, 2015. APHIS also publishes a notice in the
plant pest and therefore should not be
ADDRESSES: You may read the Federal Register announcing the
a regulated article under APHIS’
documents referenced in this notice and regulatory status of the GE organism and
regulations in 7 CFR part 340.
the comments we received at http:// the availability of APHIS’ final EA,
According to our process 1 for
www.regulations.gov/ PPRA, FONSI, and our regulatory
soliciting public comment when
determination.
tkelley on DSK3SPTVN1PROD with NOTICES

#!docketDetail;D=APHIS-2014-0007 or
in our reading room, which is located in 1 On March 6, 2012, APHIS published in the

Room 1141 of the USDA South Federal Register (77 FR 13258–13260, Docket No. www.regulations.gov/#!docketDetail;D=APHIS-
Building, 14th Street and Independence APHIS–2011–0129) a notice describing our public 2011-0129.
review process for soliciting public comments and 2 To view the notice, the petition, other
Avenue SW., Washington, DC. Normal information when considering petitions for supporting documents, and the comments we
reading room hours are 8 a.m. to 4:30 determinations of nonregulated status for GE received, go to http://www.regulations.gov/
p.m., Monday through Friday, except organisms. To view the notice, go to http:// #!docketDetail;D=APHIS-2014-0007.

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65690 Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Notices

APHIS sought public comment on a therefore are no longer subject to our unless the collection of information
draft EA and a preliminary PPRA from regulations governing the introduction displays a currently valid OMB control
June 1, 2015, to July 1, 2015.3 APHIS of certain GE organisms. number and the agency informs
solicited comments on the draft EA, the Copies of the signed determination potential persons who are to respond to
preliminary PPRA, and whether the document, PPRA, final EA, FONSI, and the collection of information that such
subject maize is likely to pose a plant response to comments, as well as the persons are not required to respond to
pest risk. APHIS received 12 comments previously published petition and the collection of information unless it
on the petition; one of these comments supporting documents, are available as displays a currently valid OMB control
had 67 documents and published indicated in the ADDRESSES and FOR number.
articles appended to it. The majority of FURTHER INFORMATION CONTACT sections
comments expressed general opposition of this notice. Food and Nutrition Service
to APHIS making a determination of Authority: 7 U.S.C. 7701–7772 and 7781– Title: 7 CFR part 215—Special Milk
nonregulated status of GE organisms. 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and Program for Children.
Issues raised during the comment 371.3. OMB Control Number: 0584–0005.
period included concerns regarding Summary of Collection: Section 3 of
Michael C. Gregoire, the Child Nutrition Act (CNA) of 1966
negative economic impacts to farmers,
Associate Administrator, Animal and Plant (Pub. L. 89–642, as amended; 42 U.S.C.
potential health and environmental
Health Inspection Service. 1772) authorizes the Special Milk
impacts, inadequate or outdated data,
[FR Doc. 2015–27284 Filed 10–26–15; 8:45 am] Program (SMP) for Children. It provides
and the possibility for insects to develop
insecticide resistance. APHIS has BILLING CODE 3410–34–P for appropriation of such sums as may
addressed the issues raised during the be necessary to enable the Secretary of
comment period and has provided Agriculture, under such rules and
DEPARTMENT OF AGRICULTURE regulations as the Secretary may deem
responses to comments as an attachment
to the FONSI. Food and Nutrition Service in the public interest, to encourage
consumption of fluid milk by children
National Environmental Policy Act
Submission for OMB Review; in the United States in (1) nonprofit
After reviewing and evaluating the Comment Request schools of high school grades and
comments received during the comment under, and (2) nonprofit nursery
period on the draft EA and preliminary October 21, 2015. schools, child care centers, settlement
PPRA and other information, APHIS has The Department of Agriculture has houses, summer camps, and similar
prepared a final EA. The EA has been submitted the following information nonprofit institutions devoted to the
prepared to provide the public with collection requirement(s) to OMB for care and training of children, which do
documentation of APHIS’ review and review and clearance under the not participate in a food service program
analysis of any potential environmental Paperwork Reduction Act of 1995, authorized under the CNA or the
impacts associated with the Public Law 104–13. Comments National School Lunch Act.
determination of nonregulated status of regarding (a) whether the collection of Need and Use of the Information: The
maize designated as event MON 87411. information is necessary for the proper SMP is administered at the State, school
The EA was prepared in accordance performance of the functions of the food authority (SFA), and child care
with: (1) NEPA, as amended (42 U.S.C. agency, including whether the institution levels. The Food and
4321 et seq.), (2) regulations of the information will have practical utility; Nutrition Service (FNS) collects
Council on Environmental Quality for (b) the accuracy of the agency’s estimate information concerning the operation of
implementing the procedural provisions of burden including the validity of the the program including the submission of
of NEPA (40 CFR parts 1500–1508), (3) methodology and assumptions used; (c) applications and agreements,
USDA regulations implementing NEPA ways to enhance the quality, utility and submission and payment of claims, and
(7 CFR part 1b), and (4) APHIS’ NEPA clarity of the information to be the maintenance of records. Without
Implementing Procedures (7 CFR part collected; (d) ways to minimize the this information FNS would not be able
372). Based on our EA, the response to burden of the collection of information to reimburse schools and institutions in
public comments, and other pertinent on those who are to respond, including a timely manner to allow them to
scientific data, APHIS has reached a through the use of appropriate properly administer the program. In
FONSI with regard to the preferred automated, electronic, mechanical, or addition, data reporting would be
alternative identified in the EA (to make other technological collection delayed and the timely monitoring of
a determination of nonregulated status techniques or other forms of information program funding and program trends
of maize designated as event MON technology should be addressed to: Desk would be affected.
87411). Officer for Agriculture, Office of Description of Respondents: State,
Information and Regulatory Affairs, Local, and Tribal Government.
Determination Office of Management and Budget Number of Respondents: 3,933.
Based on APHIS’ analysis of field and (OMB), OIRA_Submission@omb.eop.gov Frequency of Responses:
laboratory data submitted by Monsanto, or fax (202) 395–5806 and to Recordkeeping; Reporting: On Occasion,
references provided in the petition, Departmental Clearance Office, USDA, Monthly, and Annually.
peer-reviewed publications, information OCIO, Mail Stop 7602, Washington, DC Total Burden Hours: 14,914.
analyzed in the EA, the PPRA, 20250–7602. Comments regarding these
comments provided by the public, and information collections are best assured Food and Nutrition Service
tkelley on DSK3SPTVN1PROD with NOTICES

information provided in APHIS’ of having their full effect if they are Title: Supplemental Nutrition
response to those public comments, received within 30 days of this Assistance Program—Supplemental
APHIS has determined that maize notification. Copies of the submission(s) Nutrition Assistance for Victims of
designated as event MON 87411 are may be obtained by calling (202) 720– Disasters.
unlikely to pose a plant pest risk and 8958. OMB Control Number: 0584–0336.
An agency may not conduct or Summary of Collection: The authority
3 80 FR 30997–30998. sponsor a collection of information to operate the Disaster Supplemental

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Document Created: 2015-12-14 15:36:00
Document Modified: 2015-12-14 15:36:00

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 October 27, 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 65689

80 FR 65689 - Monsanto Co.; Determination of Nonregulated Status of Maize Genetically Engineered For Protection Against Corn Rootworm and Resistance to Glyphosate

DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service

Federal Register Volume 80, Issue 207 (October 27, 2015)

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service