Monsanto Co.; Availability of Petition for Determination of Nonregulated Status of Maize Genetically Engineered for Increased Ear Biomass, 2674-2675 [2015-00722]
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Notices
Federal Register
Vol. 80, No. 12
Tuesday, January 20, 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–2014–0097]
Monsanto Co.; Availability of Petition
for Determination of Nonregulated
Status of Maize Genetically Engineered
for Increased Ear Biomass
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are advising the public
that the Animal and Plant Health
Inspection Service (APHIS) has received
a petition from the Monsanto Company
(Monsanto) seeking a determination of
nonregulated status of maize designated
as event MON 87403, which has been
genetically engineered for increased ear
biomass. The petition has been
submitted in accordance with our
regulations concerning the introduction
of certain genetically engineered
organisms and products. We are making
the Monsanto petition available for
review and comment to help us identify
potential environmental and
interrelated economic issues and
impacts that APHIS may determine
should be considered in our evaluation
of the petition.
DATES: We will consider all comments
that we receive on or before March 23,
2015.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!docketDetail;D=APHIS-2014-0097.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2014–0097, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road, Unit 118,
Riverdale, MD 20737–1238.
Supporting documents and any
comments we receive on this docket
rljohnson on DSK3VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
14:47 Jan 16, 2015
Jkt 235001
may be viewed at https://
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) 799–7039
before coming.
The petition is also available on the
APHIS Web site at https://
www.aphis.usda.gov/brs/aphisdocs/14_
21301p.pdf.
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: 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.
Paragraphs (b) and (c) of § 340.6
describe the form that a petition for a
determination of nonregulated status
must take and the information that must
be included in the petition.
APHIS has received a petition (APHIS
Petition Number 14–213–01p) from the
Monsanto Company (Monsanto) of St.
Louis, MO, seeking a determination of
nonregulated status of maize (Zea mays)
PO 00000
Frm 00001
Fmt 4703
Sfmt 4703
designated as event MON 87403, which
has been genetically engineered for
increased ear biomass. The petition
states that information collected during
field trials and laboratory analyses
indicates MON 87403 maize is unlikely
to pose a plant pest risk and, therefore,
should not be a regulated article under
APHIS’ regulations in 7 CFR part 340.
MON 87403 maize is currently
regulated under 7 CFR part 340.
Interstate movements and field tests of
MON 87403 maize have been authorized
by APHIS. Field tests conducted under
APHIS oversight allowed for evaluation
in a natural agricultural setting while
imposing measures to minimize the risk
of persistence in the environment after
completion of the tests. Data are
gathered on multiple parameters and
used by the applicant to evaluate
agronomic characteristics and product
performance. These and other data are
used by APHIS to determine if the new
variety poses a plant pest risk.
Paragraph (d) of § 340.6 provides that
APHIS will publish a notice in the
Federal Register providing 60 days for
public comment for petitions for a
determination of nonregulated status.
On March 6, 2012, we published in the
Federal Register (77 FR 13258–13260,
Docket No. APHIS–2011–0129) a
notice 1 describing our process for
soliciting public comment when
considering petitions for determinations
of nonregulated status for GE organisms.
In that notice we indicated that APHIS
would accept written comments
regarding a petition once APHIS
deemed it complete.
In accordance with § 340.6(d) of the
regulations and 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 regarding the petition
for a determination of nonregulated
status from interested or affected
persons for a period of 60 days from the
date of this notice. The petition is
available for public review and
comment, and copies are available as
indicated under ADDRESSES and FOR
FURTHER INFORMATION CONTACT above.
We are interested in receiving
comments regarding potential
1 To view the notice, go to https://
www.regulations.gov/#!docketDetail;D=APHIS2011-0129.
E:\FR\FM\20JAN1.SGM
20JAN1
Federal Register / Vol. 80, No. 12 / Tuesday, January 20, 2015 / Notices
environmental and interrelated
economic issues and impacts that
APHIS may determine should be
considered in our evaluation of the
petition. We are particularly interested
in receiving comments regarding
biological, cultural, or ecological issues,
and we encourage the submission of
scientific data, studies, or research to
support your comments. We also
request that, when possible,
commenters provide relevant
information regarding specific localities
or regions as maize growth, crop
management, and crop utilization may
vary considerably by geographic region.
After the comment period closes,
APHIS will review all written comments
received during the comment period
and any other relevant information. Any
substantive issues identified by APHIS
based on our review of the petition and
our evaluation and analysis of
comments will be considered in the
development of our decisionmaking
documents.
As part of our decisionmaking process
regarding a GE organism’s regulatory
status, APHIS prepares a plant pest risk
assessment to assess its plant pest risk
and the appropriate environmental
documentation—either an
environmental assessment (EA) or an
environmental impact statement (EIS)—
in accordance with the National
Environmental Policy Act (NEPA), to
provide the Agency with a review and
analysis of any potential environmental
impacts associated with the petition
request. For petitions for which APHIS
prepares an EA, APHIS will follow our
published process for soliciting public
involvement (see footnote 1) and
publish a separate notice in the Federal
Register announcing the availability of
APHIS’ EA and plant pest risk
assessment. Should APHIS determine
that an EIS is necessary, APHIS will
complete the NEPA EIS process in
accordance with Council on
Environmental Quality regulations (40
CFR parts 1500–1508) and APHIS’
NEPA implementing regulations (7 CFR
part 372).
rljohnson on DSK3VPTVN1PROD with NOTICES
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 14th day of
January 2015.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2015–00722 Filed 1–16–15; 8:45 am]
BILLING CODE 3410–34–P
VerDate Sep<11>2014
14:47 Jan 16, 2015
Jkt 235001
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2013–0043]
Monsanto Co.; Determination of
Nonregulated Status of Herbicide
Resistant Soybean and Cotton
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are advising the public of
our determination that soybean and
cotton genetically engineered for
herbicide resistance by the Monsanto
Company are no longer considered
regulated articles under our regulations
governing the introduction of certain
genetically engineered organisms. Our
determination is based on our
evaluation of data submitted by the
Monsanto Company in its two petitions
for a determination of nonregulated
status, our analysis of publically
available scientific data, and comments
received from the public on the petition
for nonregulated status and its
associated environmental impact
statement and plant pest risk
assessments. This notice also announces
the availability of our written
determination and record of decision.
DATES: Effective Date: January 20, 2015.
ADDRESSES: You may read the
documents referenced in this notice and
any comments we received in our
reading room. The reading room 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. Those documents are also
available on the Internet at https://
www.aphis.usda.gov/biotechnology/
petitions_table_pending.shtml under
APHIS Petition Numbers 10–188–01p
(soybean) and 12–185–01p (cotton) and
are posted with the comments we
received on the Regulations.gov Web
site at https://www.regulations.gov/
#!docketDetail;D=APHIS-2013-0043.
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 documents referenced in
this notice, contact Ms. Cindy Eck at
(301) 851–3892, email: cynthia.a.eck@
aphis.usda.gov.
SUMMARY:
PO 00000
Frm 00002
Fmt 4703
Sfmt 4703
2675
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 APHIS seeking a determination that
an article should not be regulated under
7 CFR part 340. Paragraphs (b) and (c)
of § 340.6 describe the form that a
petition for a determination of
nonregulated status must take and the
information that must be included in
the petition.
APHIS received two petitions
(referred to below as ‘‘the petitions’’)
from the Monsanto Company seeking
determinations of nonregulated status
for soybean and cotton cultivars
genetically engineered to be resistant to
herbicides. The first petition, APHIS
Petition Number 10–188–01p, seeks a
determination of nonregulated status of
soybean (Glycine max) designated as
event MON 87708, which has been
genetically engineered for tolerance to
the herbicide dicamba. The second
petition, APHIS Petition Number 12–
185–01p, seeks a determination of
nonregulated status of cotton
(Gossypium spp.) designated as event
MON 88701, which has been genetically
engineered for tolerance to the
herbicides dicamba and glufosinate. The
petitions state that these articles are
unlikely to pose a plant pest risk and,
therefore, should not be regulated
articles under APHIS’ regulations in 7
CFR part 340.
Notices were published 1 in the
Federal Register for each petition
advising the public that APHIS had
received the petition and was seeking
public comments on the petition. The
notices also announced that APHIS
would prepare either an environmental
assessment or an environmental impact
SUPPLEMENTARY INFORMATION:
1 Docket No. APHIS–2012–0047 published on
July 13, 2012, 77 FR 41356–41357; Docket No.
APHIS–2012–0097 published on February 27, 2013,
78 FR 13308–13309. The Federal Register notices
for the petitions and supporting and related
materials, including public comments, are available
at https://www.regulations.gov/
#!docketDetail;D=APHIS-2012-0047 and https://
www.regulations.gov/#!docketDetail;D=APHIS2012-0097.
E:\FR\FM\20JAN1.SGM
20JAN1
]]>Agencies
[Federal Register Volume 80, Number 12 (Tuesday, January 20, 2015)]
[Notices]
[Pages 2674-2675]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00722]
========================================================================
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. 12 / Tuesday, January 20, 2015 /
Notices
[[Page 2674]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2014-0097]
Monsanto Co.; Availability of Petition for Determination of
Nonregulated Status of Maize Genetically Engineered for Increased Ear
Biomass
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service (APHIS) has received a petition from the Monsanto
Company (Monsanto) seeking a determination of nonregulated status of
maize designated as event MON 87403, which has been genetically
engineered for increased ear biomass. The petition has been submitted
in accordance with our regulations concerning the introduction of
certain genetically engineered organisms and products. We are making
the Monsanto petition available for review and comment to help us
identify potential environmental and interrelated economic issues and
impacts that APHIS may determine should be considered in our evaluation
of the petition.
DATES: We will consider all comments that we receive on or before March
23, 2015.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2014-0097.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2014-0097, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
Supporting documents and any comments we receive on this docket may
be viewed at https://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) 799-7039 before coming.
The petition is also available on the APHIS Web site at https://www.aphis.usda.gov/brs/aphisdocs/14_21301p.pdf.
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: 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. Paragraphs (b) and (c) of Sec. 340.6 describe
the form that a petition for a determination of nonregulated status
must take and the information that must be included in the petition.
APHIS has received a petition (APHIS Petition Number 14-213-01p)
from the 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 petition states that information collected during
field trials and laboratory analyses indicates MON 87403 maize is
unlikely to pose a plant pest risk and, therefore, should not be a
regulated article under APHIS' regulations in 7 CFR part 340.
MON 87403 maize is currently regulated under 7 CFR part 340.
Interstate movements and field tests of MON 87403 maize have been
authorized by APHIS. Field tests conducted under APHIS oversight
allowed for evaluation in a natural agricultural setting while imposing
measures to minimize the risk of persistence in the environment after
completion of the tests. Data are gathered on multiple parameters and
used by the applicant to evaluate agronomic characteristics and product
performance. These and other data are used by APHIS to determine if the
new variety poses a plant pest risk.
Paragraph (d) of Sec. 340.6 provides that APHIS will publish a
notice in the Federal Register providing 60 days for public comment for
petitions for a determination of nonregulated status. On March 6, 2012,
we published in the Federal Register (77 FR 13258-13260, Docket No.
APHIS-2011-0129) a notice \1\ describing our process for soliciting
public comment when considering petitions for determinations of
nonregulated status for GE organisms. In that notice we indicated that
APHIS would accept written comments regarding a petition once APHIS
deemed it complete.
---------------------------------------------------------------------------
\1\ To view the notice, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
---------------------------------------------------------------------------
In accordance with Sec. 340.6(d) of the regulations and 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 regarding the petition for a determination of
nonregulated status from interested or affected persons for a period of
60 days from the date of this notice. The petition is available for
public review and comment, and copies are available as indicated under
ADDRESSES and FOR FURTHER INFORMATION CONTACT above. We are interested
in receiving comments regarding potential
[[Page 2675]]
environmental and interrelated economic issues and impacts that APHIS
may determine should be considered in our evaluation of the petition.
We are particularly interested in receiving comments regarding
biological, cultural, or ecological issues, and we encourage the
submission of scientific data, studies, or research to support your
comments. We also request that, when possible, commenters provide
relevant information regarding specific localities or regions as maize
growth, crop management, and crop utilization may vary considerably by
geographic region.
After the comment period closes, APHIS will review all written
comments received during the comment period and any other relevant
information. Any substantive issues identified by APHIS based on our
review of the petition and our evaluation and analysis of comments will
be considered in the development of our decisionmaking documents.
As part of our decisionmaking process regarding a GE organism's
regulatory status, APHIS prepares a plant pest risk assessment to
assess its plant pest risk and the appropriate environmental
documentation--either an environmental assessment (EA) or an
environmental impact statement (EIS)--in accordance with the National
Environmental Policy Act (NEPA), to provide the Agency with a review
and analysis of any potential environmental impacts associated with the
petition request. For petitions for which APHIS prepares an EA, APHIS
will follow our published process for soliciting public involvement
(see footnote 1) and publish a separate notice in the Federal Register
announcing the availability of APHIS' EA and plant pest risk
assessment. Should APHIS determine that an EIS is necessary, APHIS will
complete the NEPA EIS process in accordance with Council on
Environmental Quality regulations (40 CFR parts 1500-1508) and APHIS'
NEPA implementing regulations (7 CFR part 372).
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 14th day of January 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-00722 Filed 1-16-15; 8:45 am]
BILLING CODE 3410-34-P
