Monsanto Co.; Availability of Preliminary Plant Pest Risk Assessment and Draft Environmental Assessment of Maize Genetically Engineered for Protection Against Corn Rootworm and Resistance to Glyphosate, 30997-30998 [2015-13164]
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30997
Notices
Federal Register
Vol. 80, No. 104
Monday, June 1, 2015
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.
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2014–0007]
Monsanto Co.; Availability of
Preliminary Plant Pest Risk
Assessment and Draft Environmental
Assessment 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
that the Animal and Plant Health
Inspection Service is making available
for public comment a preliminary plant
pest risk assessment and draft
environmental assessment for maize
designated as event MON 87411, which
has been genetically engineered for
protection against corn rootworm and
resistance to the herbicide glyphosate.
DATES: We will consider all comments
that we receive on or before July 1,
2015.
SUMMARY:
You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!docketDetail;D=APHIS-2014-0007.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2014–0007, 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
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
Lhorne on DSK2VPTVN1PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
14:50 May 29, 2015
Jkt 235001
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 for this
petition 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 petition, contact Ms. Cindy
Eck at (301) 851–3892, email:
cynthia.a.eck@aphis.usda.gov.
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 § 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 the
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.
PO 00000
Frm 00001
Fmt 4703
Sfmt 4703
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. 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 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).
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.
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=APHIS2011-0129.
2 To view the notice, the petition, and the
comments we received, go to https://
www.regulations.gov/#!docketDetail;D=APHIS2014-0007.
E:\FR\FM\01JNN1.SGM
01JNN1
Lhorne on DSK2VPTVN1PROD with NOTICES
30998
Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices
Under Approach 1, APHIS announces in
the Federal Register the availability of
APHIS’ preliminary regulatory
determination along with its EA,
preliminary finding of no significant
impact (FONSI), and its 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.
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 substantive new
issues, APHIS will follow Approach 2.
Under Approach 2, APHIS first solicits
written comments from the public on a
draft EA and preliminary PPRA for a 30day 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 will revise the
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).
For this petition, we are using Approach
2.
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.
APHIS has prepared a preliminary
PPRA and has concluded that maize
designated as event MON 87411, which
has been genetically engineered for
protection against corn rootworm and
resistance to the herbicide glyphosate, 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
VerDate Sep<11>2014
14:50 May 29, 2015
Jkt 235001
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 87411, or (2) make a
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).
In accordance with 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 on our draft EA and
our preliminary PPRA regarding the
petition for a determination of
nonregulated status from interested or
affected persons for a period of 30 days
from the date of this notice. Copies of
the draft EA and the preliminary PPRA,
as well as the previously published
petition, are available as indicated
under ADDRESSES and FOR FURTHER
INFORMATION CONTACT above.
After the comment period closes,
APHIS will review all written comments
received during the comment period
and any other relevant information.
After reviewing and evaluating the
comments on the draft EA and the
preliminary PPRA and other
information, APHIS will revise the
PPRA as necessary and prepare a final
EA. Based on the final EA, APHIS will
prepare a NEPA decision document
(either a FONSI or a notice of intent to
prepare an environmental impact
statement). If a FONSI is reached,
APHIS will furnish a response to the
petitioner, either approving or denying
the petition. APHIS will also publish 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.
Authority: 7 U.S.C. 7701–7772 and 7781–
7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
371.3.
PO 00000
Frm 00002
Fmt 4703
Sfmt 4703
Done in Washington, DC, this 22nd day of
May 2015.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2015–13164 Filed 5–29–15; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Food and Nutrition Service
Agency Information Collection
Activities: Proposed Collection;
Comment Request—USDA National
Hunger Clearinghouse Database
Forms FNS 543 and FNS 543–A
Food and Nutrition Service
(FNS), USDA.
ACTION: Notice.
AGENCY:
In accordance with the
Paperwork Reduction Act of 1995, this
notice invites the general public and
other public agencies to comment on
this proposed information collection.
This is a revision of a currently
approved collection for the purpose of
collecting information from
organizations fighting hunger and
poverty.
DATES: Written comments must be
received on or before July 31, 2015.
ADDRESSES: Comments are invited on:
(a) Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information, including the validity of
the methodology and assumptions that
were used; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on those who
are to respond, including use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Comments may be sent to: Tony
Craddock, Jr., Food and Nutrition
Service, U.S. Department of Agriculture,
3101 Park Center Drive, Room 941,
Alexandria, VA 22302. Comments may
also be submitted via email to Tony
Craddock, Jr. at tony.craddock@
fns.usda.gov. Comments will also be
accepted through the Federal
eRulemaking Portal. Go to https://
www.regulations.gov and follow the
online instructions for submitting
comments electronically. Comments
will also be accepted through the
SUMMARY:
E:\FR\FM\01JNN1.SGM
01JNN1
]]>Agencies
[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)]
[Notices]
[Pages 30997-30998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13164]
========================================================================
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.
========================================================================
Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 /
Notices
[[Page 30997]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2014-0007]
Monsanto Co.; Availability of Preliminary Plant Pest Risk
Assessment and Draft Environmental Assessment 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 that the Animal and Plant Health
Inspection Service is making available for public comment a preliminary
plant pest risk assessment and draft environmental assessment for maize
designated as event MON 87411, which has been genetically engineered
for protection against corn rootworm and resistance to the herbicide
glyphosate.
DATES: We will consider all comments that we receive on or before July
1, 2015.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2014-0007.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2014-0007, 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 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 for this petition 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 petition, contact Ms. Cindy Eck at (301) 851-3892, email:
cynthia.a.eck@aphis.usda.gov.
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
13-290-01p) from the 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.
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 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).
---------------------------------------------------------------------------
\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, and the comments we
received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-
2014-0007.
---------------------------------------------------------------------------
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.
[[Page 30998]]
Under Approach 1, APHIS announces in the Federal Register the
availability of APHIS' preliminary regulatory determination along with
its EA, preliminary finding of no significant impact (FONSI), and its
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.
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 substantive new issues, APHIS will 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 will revise the 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). For this
petition, we are using Approach 2.
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.
APHIS has prepared a preliminary PPRA and has concluded that maize
designated as event MON 87411, which has been genetically engineered
for protection against corn rootworm and resistance to the herbicide
glyphosate, 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 87411, or
(2) make a 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).
In accordance with 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 on our draft EA and our preliminary
PPRA regarding the petition for a determination of nonregulated status
from interested or affected persons for a period of 30 days from the
date of this notice. Copies of the draft EA and the preliminary PPRA,
as well as the previously published petition, are available as
indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
After the comment period closes, APHIS will review all written
comments received during the comment period and any other relevant
information. After reviewing and evaluating the comments on the draft
EA and the preliminary PPRA and other information, APHIS will revise
the PPRA as necessary and prepare a final EA. Based on the final EA,
APHIS will prepare a NEPA decision document (either a FONSI or a notice
of intent to prepare an environmental impact statement). If a FONSI is
reached, APHIS will furnish a response to the petitioner, either
approving or denying the petition. APHIS will also publish 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.
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 May 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-13164 Filed 5-29-15; 8:45 am]
BILLING CODE 3410-34-P
