Monsanto Co.; Determination of Nonregulated Status of Maize Genetically Engineered For Protection Against Corn Rootworm and Resistance to Glyphosate, 65689-65690 [2015-27284]
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Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Notices
our final regulatory determination. No
further Federal Register notice will be
published announcing the final
regulatory determination regarding
MZHG0JG corn.
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 22nd day of
October.
Michael C. Gregoire,
Associate Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2015–27296 Filed 10–26–15; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
Monsanto Co.; Determination of
Nonregulated Status of Maize
Genetically Engineered For Protection
Against Corn Rootworm and
Resistance to Glyphosate
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
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 https://
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
tkelley on DSK3SPTVN1PROD with NOTICES
VerDate Sep<11>2014
19:58 Oct 26, 2015
Jkt 238001
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 § 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
SUPPLEMENTARY INFORMATION:
[Docket No. APHIS–2014–0007]
SUMMARY:
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
https://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:
john.t.turner@aphis.usda.gov. To obtain
copies of the supporting documents for
this petition, contact Ms. Cindy Eck at
(301) 851–3892, email: cynthia.a.eck@
aphis.usda.gov.
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 https://
PO 00000
Frm 00003
Fmt 4703
Sfmt 4703
65689
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.
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.
www.regulations.gov/#!docketDetail;D=APHIS2011-0129.
2 To view the notice, the petition, other
supporting documents, and the comments we
received, go to https://www.regulations.gov/
#!docketDetail;D=APHIS-2014-0007.
E:\FR\FM\27OCN1.SGM
27OCN1
65690
Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Notices
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.
tkelley on DSK3SPTVN1PROD with NOTICES
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
3 80
FR 30997–30998.
VerDate Sep<11>2014
19:58 Oct 26, 2015
Jkt 238001
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
DEPARTMENT OF AGRICULTURE
Food and Nutrition Service
Submission for OMB Review;
Comment Request
October 21, 2015.
The Department of Agriculture has
submitted the following information
collection requirement(s) to OMB for
review and clearance under the
Paperwork Reduction Act of 1995,
Public Law 104–13. Comments
regarding (a) whether the collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information will have practical utility;
(b) the accuracy of the agency’s estimate
of burden including the validity of the
methodology and assumptions used; (c)
ways to enhance the quality, utility and
clarity of the information to be
collected; (d) ways to minimize the
burden of the collection of information
on those who are to respond, including
through the use of appropriate
automated, electronic, mechanical, or
other technological collection
techniques or other forms of information
technology should be addressed to: Desk
Officer for Agriculture, Office of
Information and Regulatory Affairs,
Office of Management and Budget
(OMB), OIRA_Submission@omb.eop.gov
or fax (202) 395–5806 and to
Departmental Clearance Office, USDA,
OCIO, Mail Stop 7602, Washington, DC
20250–7602. Comments regarding these
information collections are best assured
of having their full effect if they are
received within 30 days of this
notification. Copies of the submission(s)
may be obtained by calling (202) 720–
8958.
An agency may not conduct or
sponsor a collection of information
PO 00000
Frm 00004
Fmt 4703
Sfmt 4703
unless the collection of information
displays a currently valid OMB control
number and the agency informs
potential persons who are to respond to
the collection of information that such
persons are not required to respond to
the collection of information unless it
displays a currently valid OMB control
number.
Food and Nutrition Service
Title: 7 CFR part 215—Special Milk
Program for Children.
OMB Control Number: 0584–0005.
Summary of Collection: Section 3 of
the Child Nutrition Act (CNA) of 1966
(Pub. L. 89–642, as amended; 42 U.S.C.
1772) authorizes the Special Milk
Program (SMP) for Children. It provides
for appropriation of such sums as may
be necessary to enable the Secretary of
Agriculture, under such rules and
regulations as the Secretary may deem
in the public interest, to encourage
consumption of fluid milk by children
in the United States in (1) nonprofit
schools of high school grades and
under, and (2) nonprofit nursery
schools, child care centers, settlement
houses, summer camps, and similar
nonprofit institutions devoted to the
care and training of children, which do
not participate in a food service program
authorized under the CNA or the
National School Lunch Act.
Need and Use of the Information: The
SMP is administered at the State, school
food authority (SFA), and child care
institution levels. The Food and
Nutrition Service (FNS) collects
information concerning the operation of
the program including the submission of
applications and agreements,
submission and payment of claims, and
the maintenance of records. Without
this information FNS would not be able
to reimburse schools and institutions in
a timely manner to allow them to
properly administer the program. In
addition, data reporting would be
delayed and the timely monitoring of
program funding and program trends
would be affected.
Description of Respondents: State,
Local, and Tribal Government.
Number of Respondents: 3,933.
Frequency of Responses:
Recordkeeping; Reporting: On Occasion,
Monthly, and Annually.
Total Burden Hours: 14,914.
Food and Nutrition Service
Title: Supplemental Nutrition
Assistance Program—Supplemental
Nutrition Assistance for Victims of
Disasters.
OMB Control Number: 0584–0336.
Summary of Collection: The authority
to operate the Disaster Supplemental
E:\FR\FM\27OCN1.SGM
27OCN1
]]>Agencies
[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Notices]
[Pages 65689-65690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27284]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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
https://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: john.t.turner@aphis.usda.gov. To obtain copies
of the supporting documents for this petition, contact Ms. Cindy Eck at
(301) 851-3892, email: cynthia.a.eck@aphis.usda.gov.
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.
---------------------------------------------------------------------------
\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
https://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 https://www.regulations.gov/#!docketDetail;D=APHIS-2014-0007.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\3\ 80 FR 30997-30998.
---------------------------------------------------------------------------
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
