Monsanto Co.; Availability of a Preliminary Plant Pest Risk Assessment, Draft Environmental Assessment, Preliminary Finding of No Significant Impact, and Preliminary Determination of Nonregulated Status for Maize Genetically Engineered for Resistance to Dicamba and Glufosinate, 8035-8037 [2016-03194]
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Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Notices
active against D. virgifera virgifera and
certain other coleopteran pests of corn.
The native Cry1Ab from B. thuringiensis
subsp. kurstaki is active against certain
lepidopteran pests, however, the portion
of Cry1Ab included in eCry3.1Ab does
not retain activity against lepidopterans.
The transgene pat-08 was derived from
the soil bacterium Streptomyces
viridochromogenes. The PAT enzyme
deactivates glufosinate herbicides thus
conferring glufosinate resistance to the
plants. PAT was also used as a
selectable marker in the development of
MZIR098 corn. The antecedent
organism, Pioneer 4114 corn, was
similarly genetically engineered to
produce proteins which have the same
mechanisms of action as do the proteins
produced in MZIR098 corn. Based on
the information in the request, we have
concluded that MZIR098 corn is similar
to Pioneer 4114 corn. MZIR098 corn is
currently regulated under 7 CFR part
340.
As part of our decisionmaking process
regarding a GE organism’s regulatory
status, APHIS evaluates the plant pest
risk of the article. In section 403 of the
PPA, ‘‘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
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 completed a plant pest risk
assessment (PPRA) on the antecedent
organism in which we concluded that
Pioneer 4114 corn is unlikely to present
plant pest risks. APHIS also prepared a
plant pest risk similarity assessment
(PPRSA) to compare MZIR098 to the
antecedent. As described in the PPRSA,
the proteins expressed in MZIR098 corn
are similar to those expressed in Pioneer
4114 corn, and APHIS has concluded
that the proteins expressed in Pioneer
4114 corn are unlikely to pose a plant
health risk. Furthermore, the
Environmental Protection Agency
reviewed the safety of the proteins
expressed in MZIR098 corn and
concluded that there would ‘‘no
unreasonable adverse effects on the
environment’’ from exposures to these
proteins. Therefore, based on our PPRA
for Pioneer 4114 corn and the similarity
between Pioneer 4114 corn and
MZIR098 corn as described in the
PPRSA, APHIS has concluded that the
proteins expressed in MZIR098 corn are
unlikely to pose a plant pest risk.
In addition, APHIS has carefully
examined the existing National
Environmental Policy Act (NEPA)
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documentation completed for Pioneer
4114 corn and has concluded that
Syngenta’s request to extend a
determination of nonregulated status to
MZIR098 corn encompasses the same
scope of environmental analysis as
Pioneer 4114 corn. Therefore, based on
the similarity of MZIR098 corn to
Pioneer 4114 corn, APHIS has prepared
a preliminary finding of no significant
impact (FONSI) on MZIR098 corn. The
FONSI 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).
APHIS is considering the following
alternatives: (1) Take no action, i.e.,
APHIS would not change the regulatory
status of MZIR098 corn and it would
continue to be a regulated article, or (2)
make a determination of nonregulated
status of MZIR098 corn. APHIS’
preferred alternative is to make a
determination of nonregulated status of
MZIR098 corn.
APHIS has analyzed information
submitted by Syngenta, references
provided in the extension request, peerreviewed publications, and information
in the NEPA documentation prepared
for the antecedent organism. APHIS has
also analyzed information in the PPRA
for the antecedent organism and other
information. Based on APHIS’ analysis
of this information and the similarity of
MZIR098 corn to the antecedent
organism Pioneer’s 4114 corn, APHIS
has determined that MZIR098 corn is
unlikely to pose a plant pest risk. We
have therefore reached a preliminary
decision to approve the request to
extend the determination of
nonregulated status of Pioneer 4114
corn to MZIR098 corn, whereby
MZIR098 corn would no longer be
subject to our regulations governing the
introduction of certain genetically
engineered organisms.
Paragraph (e) of § 340.6 provides that
APHIS will publish a notice in the
Federal Register announcing all
preliminary decisions to extend
determinations of nonregulated status
for 30 days before the decisions become
final and effective. In accordance with
§ 340.6(e) of the regulations, we are
publishing this notice to inform the
public of our preliminary decision to
extend the determination of
nonregulated status of Pioneer 4114
corn to MZIR098 corn.
APHIS will accept written comments
on the preliminary FONSI regarding a
PO 00000
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8035
determination of nonregulated status of
MZIR098 corn for a period of 30 days
from the date this notice is published in
the Federal Register. The preliminary
FONSI, as well as the extension request,
supporting documents, and our
preliminary determination with
appended PPRSA for MZIR098 corn, are
available for public review as indicated
under ADDRESSES and FOR FURTHER
INFORMATION CONTACT above. Copies of
these documents may also be obtained
by contacting the person listed under
FOR FURTHER INFORMATION CONTACT.
After the comment period closes,
APHIS will review all written comments
received during the comment period
and any other relevant information. All
comments will be available for public
review. After reviewing and evaluating
the comments, if APHIS determines that
no substantive information has been
received that would warrant APHIS
altering its preliminary regulatory
determination or FONSI, our
preliminary regulatory determination
will become final and effective upon
notification of the public through an
announcement on our Web site at https://
www.aphis.usda.gov/biotechnology/
petitions_table_pending.shtml. APHIS
will also furnish a response to the
petitioner regarding our final regulatory
determination. No further Federal
Register notice will be published
announcing the final regulatory
determination regarding MZIR098 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 10th day of
February 2016.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2016–03193 Filed 2–16–16; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2015–0048]
Monsanto Co.; Availability of a
Preliminary Plant Pest Risk
Assessment, Draft Environmental
Assessment, Preliminary Finding of No
Significant Impact, and Preliminary
Determination of Nonregulated Status
for Maize Genetically Engineered for
Resistance to Dicamba and
Glufosinate
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
E:\FR\FM\17FEN1.SGM
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8036
Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Notices
We are advising the public
that the Animal and Plant Health
Inspection Service has prepared a
preliminary determination regarding a
request from Monsanto Co. seeking a
determination of nonregulated status for
maize designated as event MON 87419,
which has been genetically engineered
for resistance to the herbicides dicamba
and glufosinate. We are also making
available for public review and
comment our preliminary plant pest risk
assessment, draft environmental
assessment, and preliminary finding of
no significant impact for the
preliminary determination of
nonregulated status.
DATES: We will consider all comments
that we receive on or before March 18,
2016.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!docketDetail;D=APHIS-2015-0048.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2015–0048, 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-2015-0048 or in our reading
room, which is located in room 1141 of
the USDA South Building, 14th Street
and Independence Avenue SW.,
Washington, DC. Normal reading room
hours are 8 a.m. to 4:30 p.m., Monday
through Friday, except holidays. To be
sure someone is there to help you,
please call (202) 7997039 before coming.
Supporting documents 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 15–113–01p.
FOR FURTHER INFORMATION CONTACT: Dr.
John Turner, Director, Biotechnology
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
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
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19:05 Feb 16, 2016
Jkt 238001
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 15–113–01p) from the
Monsanto Company (Monsanto) of St.
Louis, MO, seeking a determination of
nonregulated status of maize (Zea mays)
designated as event MON 87419, which
has been genetically engineered for
resistance to the herbicides dicamba and
glufosinate. The Monsanto petition
states that information collected during
field trials and laboratory analyses
indicates that MON 87419 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 August 13, 2015
(80 FR 48489–48490, Docket No.
APHIS–2015–0048), APHIS announced
the availability of the Monsanto petition
for public comment. APHIS solicited
comments on the petition for 60 days
ending on October 13, 2015, in order to
help identify potential environmental
and interrelated economic issues and
impacts that APHIS may determine
should be considered in our evaluation
of the petition. APHIS received 21
comments on the petition, one of which
included over 23,000 signatures
opposing the petition. APHIS has
evaluated the issues raised during the
comment period and, where
appropriate, has provided a discussion
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=APHIS2015-0048.
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Fmt 4703
Sfmt 4703
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.
Under Approach 1, APHIS announces in
the Federal Register the availability of
APHIS’ preliminary regulatory
determination along with its draft EA,
preliminary finding of no significant
impact (FONSI), and its preliminary
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. For this petition, we are
using Approach 1.
Had APHIS decided, 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 would
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 would
revise the preliminary 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).
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.
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asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Notices
APHIS has prepared a preliminary
PPRA and has concluded that maize
designated as event MON 87419, which
has been genetically engineered for
resistance to the herbicides dicamba and
glufosinate, 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 87419, or (2) make a
determination of nonregulated status of
maize designated as event MON 87419.
The draft 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 draft EA and other pertinent
scientific data, APHIS has prepared a
preliminary FONSI with regard to the
preferred alternative identified in the
draft EA.
Based on APHIS’ analysis of field and
laboratory data submitted by Monsanto,
references provided in the petition,
peer-reviewed publications, information
analyzed in the draft EA, the
preliminary PPRA, comments provided
by the public on the petition, and
discussion of issues in the draft EA,
APHIS has determined that maize
designated as event MON 87419 is
unlikely to pose a plant pest risk. We
have therefore reached a decision to
make a preliminary determination of
nonregulated status of maize designated
as event MON 87419, whereby maize
designated as event MON 87419 would
no longer be subject to our regulations
governing the introduction of certain GE
organisms.
We are making available for a 30-day
review period APHIS’ preliminary
regulatory determination of maize
designated as event MON 87419, along
with our preliminary PPRA, draft EA,
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19:05 Feb 16, 2016
Jkt 238001
and preliminary FONSI for the
preliminary determination of
nonregulated status. The draft EA,
preliminary FONSI, preliminary PPRA,
and our preliminary determination for
maize designated as event MON 87419,
as well as the Monsanto petition and the
comments received on the petition, are
available as indicated under ADDRESSES
and FOR FURTHER INFORMATION CONTACT
above. Copies of these documents may
also be obtained from the person listed
under FOR FURTHER INFORMATION
CONTACT.
After the 30-day review period closes,
APHIS will review and evaluate any
information received during the 30-day
review period. If, after evaluating the
information received, APHIS determines
that we have not received substantive
new information that would warrant
APHIS altering our preliminary
regulatory determination or FONSI,
substantially changing the proposed
action identified in the draft EA, or
substantially changing the analysis of
impacts in the draft EA, APHIS will
notify the public through an
announcement on our Web site of our
final regulatory determination. If,
however, APHIS determines that we
have received substantive new
information that would warrant APHIS
altering our preliminary regulatory
determination or FONSI, substantially
changing the proposed action identified
in the draft EA, or substantially
changing the analysis of impacts in the
draft EA, then APHIS will conduct the
additional analysis and prepare an
amended EA, a new FONSI, and/or a
revised PPRA, which would be made
available for public review in a
subsequent notice in the Federal
Register, similar to an Approach 2
petition. APHIS will also notify the
petitioner.
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 10th day of
February 2016.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2016–03194 Filed 2–16–16; 8:45 am]
BILLING CODE 3410–34–P
8037
Notice of intent to prepare a
supplemental environmental impact
statement.
ACTION:
The Ochoco National Forest is
preparing a supplemental
environmental impact statement (EIS) to
analyze the effects of changing the
existing motorized trail system to create
and designate a sustainable system of
roads, trails and areas open to motor
vehicles that will provide legal public
access, enhance regulation of
unmanaged wheeled motor vehicle
travel, protect resources, and decrease
conflicts between motorized and nonmotorized use on the Ochoco National
Forest. Consistent with the Ochoco
National Forest Land and Resource
Management Plan, as amended, this
action is needed to provide to the public
a diversity of road and trail
opportunities for experiencing a variety
of environments and modes of travel.
The original notice of intent to prepare
an environmental impact statement was
published in the Federal Register on
November 20, 2009 (74 FR 60235–
60236). The supplemental
environmental impact statement is
being prepared because a 2014 wildfire
in the project area changed the
conditions initially analyzed so that
additional analysis was required, and
because the responsible official desired
to have additional discussions with
stakeholders prior to making a decision.
The Ochoco Summit Trail System
decision and the reasons for the
decision will be documented in the
record of decision. That decision will be
subject to the Forest Service Projectlevel Predecisional Administrative
Review Process (36 CFR part 218).
SUMMARY:
The supplemental draft
environmental impact statement is
expected to be completed and available
for public comment in February 2016.
The final environmental impact
statement is expected to be completed
in the fall of 2016.
DATES:
Ochoco Summit Trail
System Planning Team, Ochoco
National Forest, 3160 NE Third Street,
Prineville, Oregon 97754.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF AGRICULTURE
Forest Service
Ochoco National Forest, Lookout
Mountain Ranger District; Oregon;
Ochoco Summit Trail System Project
Supplemental EIS
AGENCY:
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Frm 00004
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Sfmt 4703
Marcy Anderson, Project Leader, at 3160
NE Third Street, Prineville, Oregon
97754, or at (541) 416–6463, or by email
at marcelleanderson@fs.fed.us.
Dated: February 10, 2016.
Stacey L. Forson,
Forest Supervisor.
[FR Doc. 2016–03174 Filed 2–16–16; 8:45 am]
BILLING CODE 3410–11–P
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]]>Agencies
[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)]
[Notices]
[Pages 8035-8037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03194]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2015-0048]
Monsanto Co.; Availability of a Preliminary Plant Pest Risk
Assessment, Draft Environmental Assessment, Preliminary Finding of No
Significant Impact, and Preliminary Determination of Nonregulated
Status for Maize Genetically Engineered for Resistance to Dicamba and
Glufosinate
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 8036]]
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has prepared a preliminary determination regarding a
request from Monsanto Co. seeking a determination of nonregulated
status for maize designated as event MON 87419, which has been
genetically engineered for resistance to the herbicides dicamba and
glufosinate. We are also making available for public review and comment
our preliminary plant pest risk assessment, draft environmental
assessment, and preliminary finding of no significant impact for the
preliminary determination of nonregulated status.
DATES: We will consider all comments that we receive on or before March
18, 2016.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2015-0048.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2015-0048, 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-2015-0048 or in our reading room, which is
located in room 1141 of the USDA South Building, 14th Street and
Independence Avenue SW., Washington, DC. Normal reading room hours are
8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure
someone is there to help you, please call (202) 7997039 before coming.
Supporting documents 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 15-113-01p.
FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director,
Biotechnology 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
15-113-01p) from the Monsanto Company (Monsanto) of St. Louis, MO,
seeking a determination of nonregulated status of maize (Zea mays)
designated as event MON 87419, which has been genetically engineered
for resistance to the herbicides dicamba and glufosinate. The Monsanto
petition states that information collected during field trials and
laboratory analyses indicates that MON 87419 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 August 13, 2015 (80 FR 48489-48490, Docket No. APHIS-2015-
0048), APHIS announced the availability of the Monsanto petition for
public comment. APHIS solicited comments on the petition for 60 days
ending on October 13, 2015, in order to help identify potential
environmental and interrelated economic issues and impacts that APHIS
may determine should be considered in our evaluation of the petition.
APHIS received 21 comments on the petition, one of which included over
23,000 signatures opposing the petition. 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-
2015-0048.
---------------------------------------------------------------------------
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. Under Approach 1, APHIS announces in
the Federal Register the availability of APHIS' preliminary regulatory
determination along with its draft EA, preliminary finding of no
significant impact (FONSI), and its preliminary 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. For this
petition, we are using Approach 1.
Had APHIS decided, 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 would 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 would revise the
preliminary 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).
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.
[[Page 8037]]
APHIS has prepared a preliminary PPRA and has concluded that maize
designated as event MON 87419, which has been genetically engineered
for resistance to the herbicides dicamba and glufosinate, 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 87419, or
(2) make a determination of nonregulated status of maize designated as
event MON 87419.
The draft 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 draft EA and other pertinent scientific data,
APHIS has prepared a preliminary FONSI with regard to the preferred
alternative identified in the draft EA.
Based on APHIS' analysis of field and laboratory data submitted by
Monsanto, references provided in the petition, peer-reviewed
publications, information analyzed in the draft EA, the preliminary
PPRA, comments provided by the public on the petition, and discussion
of issues in the draft EA, APHIS has determined that maize designated
as event MON 87419 is unlikely to pose a plant pest risk. We have
therefore reached a decision to make a preliminary determination of
nonregulated status of maize designated as event MON 87419, whereby
maize designated as event MON 87419 would no longer be subject to our
regulations governing the introduction of certain GE organisms.
We are making available for a 30-day review period APHIS'
preliminary regulatory determination of maize designated as event MON
87419, along with our preliminary PPRA, draft EA, and preliminary FONSI
for the preliminary determination of nonregulated status. The draft EA,
preliminary FONSI, preliminary PPRA, and our preliminary determination
for maize designated as event MON 87419, as well as the Monsanto
petition and the comments received on the petition, are available as
indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
Copies of these documents may also be obtained from the person listed
under FOR FURTHER INFORMATION CONTACT.
After the 30-day review period closes, APHIS will review and
evaluate any information received during the 30-day review period. If,
after evaluating the information received, APHIS determines that we
have not received substantive new information that would warrant APHIS
altering our preliminary regulatory determination or FONSI,
substantially changing the proposed action identified in the draft EA,
or substantially changing the analysis of impacts in the draft EA,
APHIS will notify the public through an announcement on our Web site of
our final regulatory determination. If, however, APHIS determines that
we have received substantive new information that would warrant APHIS
altering our preliminary regulatory determination or FONSI,
substantially changing the proposed action identified in the draft EA,
or substantially changing the analysis of impacts in the draft EA, then
APHIS will conduct the additional analysis and prepare an amended EA, a
new FONSI, and/or a revised PPRA, which would be made available for
public review in a subsequent notice in the Federal Register, similar
to an Approach 2 petition. APHIS will also notify the petitioner.
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 10th day of February 2016.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-03194 Filed 2-16-16; 8:45 am]
BILLING CODE 3410-34-P
