ArborGen Inc.; Availability of Petition, Notice of Intent To Prepare an Environmental Impact Statement for Determination of Nonregulated Status of Freeze Tolerant Eucalyptus Lines, and Notice of Virtual Public Meetings, 13309-13312 [2013-04519]
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Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices
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 12–185–01p) from the
Monsanto Company (Monsanto) of St.
Louis, MO, seeking a determination of
nonregulated status of cotton designated
as event MON 88701, which has been
genetically engineered for tolerance to
the herbicides dicamba and glufosinate.
The petition states that this cotton is
unlikely to pose a plant pest risk and,
therefore, should not be a regulated
article under APHIS’ regulations in 7
CFR part 340.
As described in the petition, cotton
event MON 88701 has been genetically
engineered to allow in-crop applications
of dicamba herbicide for the control of
broadleaf weeds from preemergence to 7
days preharvest and glufosinate
herbicide for broad spectrum weed
control from emergence through early
bloom growth stage. Cotton event MON
88701 provides dicamba tolerance that
allows for the in-crop application of
dicamba beyond the current preplant
uses in cotton and also provides
glufosinate tolerance equivalent to
current commercial glufosinate-tolerant
cotton events. Cotton event MON 88701
is currently regulated under 7 CFR part
340. Interstate movements and field
tests of cotton event MON 88701 have
been conducted under notifications
acknowledged 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 test. Data are gathered
on multiple parameters and used by the
applicant to evaluate agronomic
characteristics and product
performance. These and other data are
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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 copies
are available as indicated under
ADDRESSES and FOR FURTHER
INFORMATION CONTACT above. We are
interested in receiving comments
regarding potential 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 cotton 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
1 To view the notice, go to https://
www.regulations.gov/#!docketDetail;D=APHIS2011-0129.
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13309
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
comment (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 part 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 22nd day of
February 2013.
Michael Gregoire,
Deputy Administrator, Biotechnology
Regulatory Services, Animal and Plant Health
Inspection Service.
[FR Doc. 2013–04522 Filed 2–26–13; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2012–0030]
ArborGen Inc.; Availability of Petition,
Notice of Intent To Prepare an
Environmental Impact Statement for
Determination of Nonregulated Status
of Freeze Tolerant Eucalyptus Lines,
and Notice of Virtual Public Meetings
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
SUMMARY: We are advising the public
that the Animal and Plant Health
Inspection Service has received a
petition from ArborGen Inc. seeking a
determination of nonregulated status of
Freeze Tolerant Eucalyptus lines
designated 427 and 435, which have
been genetically engineered (GE) to be
more tolerant of cold conditions. The
incorporation of the GE trait allows
these eucalyptus hybrid trees to be
grown in a broader geographic area than
non-GE eucalyptus hybrid trees. The
petition has been submitted in
accordance with our regulations
concerning the introduction of certain
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Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices
GE organisms and products. We are
making available for public comment
the ArborGen Inc. petition and are
soliciting comments on whether these
GE eucalyptus lines are likely to pose a
plant pest risk. We are also announcing
to the public our intent to prepare an
environmental impact statement (EIS)
on the action with regard to the petition
for nonregulated status, identifying
potential issues and alternatives that
may be studied in the EIS, and
requesting public comments to further
delineate the scope of the alternatives
and environmental impacts and issues.
We are also announcing that APHIS will
be hosting two virtual meetings during
the comment period. The purpose of the
meetings will be to further delineate the
scope of alternatives and environmental
impacts and issues discussed in the EIS.
DATES: We will consider all comments
that we receive on or before April 29,
2013. We will also consider comments
made at virtual public meetings that
will be held during the comment period.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!documentDetail;D=APHIS-2012-00300001.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2012–0030, 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-2012-0030 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.
The petition is also available on the
APHIS Web site at https://
www.aphis.usda.gov/brs/aphisdocs/
11_01901p.pdf.
Other Information: Details regarding
the virtual meetings, including times,
dates, and how to participate, will be
available at https://
www.aphisvirtualmeetings.com.
FOR FURTHER INFORMATION CONTACT: Dr.
John Turner, Director, Environmental
Risk Analysis Programs, Biotechnology
Regulatory Services, APHIS, 4700 River
Road Unit 147, Riverdale, MD 20737–
1238; (301) 851–3954. To obtain copies
of the petition, contact Ms. Cindy Eck at
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(301) 851–851–3882, email:
cynthia.a.eck@aphis.usda.gov.
SUPPLEMENTARY INFORMATION:
Background
Under the authority of the plant pest
provisions of the Plant Protection Act
(PPA) (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.
Proposed Action
APHIS has received a petition (APHIS
Petition Number 11–019–01p) from
ArborGen Inc. of Summerville, SC,
seeking a determination of nonregulated
status of two Freeze Tolerant Eucalyptus
(FTE) lines designated 427 and 435. The
petition states that these eucalyptus
trees are unlikely to pose a plant pest
risk and, therefore, should not be a
regulated article under APHIS’
regulations in 7 CFR part 340. These
regulations are authorized by the PPA to
prevent the introduction or
dissemination of plant pests, and the
decision on whether or not to grant the
petition will be based on this standard.
As described in the petition, FTE
lines 427 and 435 have been genetically
engineered to express the CBF2 gene to
be more tolerant of cold conditions and
a gene expression cassette that prevents
pollen development. FTE lines 427 and
435 are currently regulated under 7 CFR
part 340. Field tests of FTE lines 427
and 435 have been conducted under
permits issued by APHIS at multiple
sites representing both freeze stress and
freeze stress-free environments in the
southeastern United States, Alabama,
Florida, Georgia, Louisiana, Mississippi,
South Carolina, and Texas.
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APHIS has conducted three separate
environmental assessments (EA) on
actions related to permitting confined
field releases of FTE trees under
conditions designed to prevent spread
of the trees outside the field test area,
and in each case announced the
availability of the EA in the Federal
Register. These notices 1 were published
on April 20, 2007 (Docket No. APHIS–
2007–0027, 72 FR 19876–19877), June 3,
2009 (Docket No. APHIS–2008–0059, 74
FR 26648–26649), and February 10,
2012 (Docket No. APHIS–2011–0130; 77
FR 7123–7124). In these assessments,
APHIS concluded that the field trials
would not pose a plant pest risk and
that issuing permits for the field trials
would not significantly affect the
quality of the human environment.
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 copies
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. All
comments received will be available for
public review. Any substantive issues
identified by APHIS based on our
review of the petition and our
evaluation and analysis of the
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 EA or an
environmental impact statement (EIS)—
in accordance with the National
Environmental Policy Act of 1969, as
amended (42 U.S.C. 4321 et seq.)
(NEPA), to provide the Agency with a
review and analysis of any potential
environmental impacts associated with
the petition request. Upon completion
of these documents, APHIS will furnish
1 The notices and environmental assessments are
available at https://www.regulations.gov/
#!docketDetail;D=APHIS-2007-0027, https://
www.regulations.gov/#!docketDetail;D=APHIS2008-0059, and https://www.regulations.gov/
#!docketDetail;D=APHIS-2011-0130.
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a response to the petitioner and will
notify the public of our regulatory
determination.
Under the provisions of NEPA,
Federal agencies must examine the
potential environmental impacts of
proposed Federal actions before actions
are taken. In accordance with NEPA,
regulations of the Council on
Environmental Quality for
implementing the procedural provisions
of NEPA (40 CFR parts 1500–1508), U.S.
Department of Agriculture (USDA)
regulations implementing NEPA (7 CFR
part 1b) and APHIS’ NEPA
Implementing Procedures (7 CFR part
372), APHIS has considered how to
properly examine these potential
environmental impacts. In each of the
previous three APHIS actions
concerning FTE trees, we determined
that an EA was the appropriate means
to consider and document
environmental impacts. Also, in
response to a legal challenge to the
adequacy of these EAs and the NEPA
process, the United States District Court
for the Southern District of Florida
granted summary judgment affirming
the APHIS actions (Case No. 10–14175–
ClV–MOORE/LYNCH).
An EA might also be used in this case,
where the relevant Federal action would
be determination of nonregulated status
of two FTE lines. However, APHIS is
choosing the option of preparing an EIS
to analyze the potential environmental
impacts of responding to this petition
request.
APHIS is exercising its option to
prepare an EIS rather than an EA to
address unresolved proposed or adopted
local, regional, State, interstate, or
Federal land use plans or policies that
may result in adverse environmental
impacts. In preparing an EIS, APHIS
would be responsive to other agencies
that have an interest in the possible
future establishment of FTE trees in
forest areas. Federal and State agencies
have expressed interest in this issue
from several perspectives. The USDA
Forest Service has agreed to serve as a
cooperating agency in the preparation of
this EIS and will provide expertise in
hydrology, to assess the effects of
eucalyptus on water resources, and
economic modeling, to predict where in
the United States FTE trees may be
adopted. The United States Department
of Energy considers eucalyptus as a
candidate bioenergy feedstock. The
United States Fish and Wildlife Service
has expressed interest in studies of the
impacts of eucalyptus tree plantations
on wildlife diversity and ecosystem
sustainability. Various States, including
Georgia and Florida, have conducted
studies or hearings on the possible use
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of tree plantations as sources of
bioenergy feedstocks. APHIS believes
that choosing to prepare an EIS rather
than an EA would allow us to fully
consider potential environmental
impacts of the Federal action under
consideration and would also provide,
in an efficient way, data that could
address a wide variety of government
interests and could shed light on issues
relevant to possible future actions under
the jurisdiction of interested agencies.
By preparing an EIS at this time, APHIS
may provide agencies with an
opportunity to adopt all or part of the
EIS for future actions in accordance
with the adoption provisions of the
Council on Environmental Quality’s
NEPA implementing regulations (40
CFR 1506.3).
Alternatives
This notice identifies reasonable
alternatives and potential issues that
may be studied in the EIS. We are
requesting public comments to further
delineate the scope of alternatives and
environmental impacts and issues. We
will be hosting two virtual meetings
during the comment period to discuss
the scope of the EIS (see ADDRESSES
above). 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.
The EIS will consider a range of
reasonable alternatives. APHIS is
considering including a ‘‘no action’’ and
‘‘approve the petition request’’
alternatives. Under the ’’no action’’
alternative, in accordance with 7 CFR
part 340, FTE would continue to be
regulated and the environmental release
and interstate movement of FTE lines
427 and 435 would require permits
issued or notifications acknowledged by
APHIS. APHIS might choose this
alternative if there was insufficient
evidence to demonstrate that the
regulated eucalyptus events were not
plant pests or the lack of plant pest risk
from the unconfined cultivation of FTE
lines 427 and 435. Under the ‘‘approve
the petition request’’ alternative, FTE
lines 427 and 435 would no longer be
regulated articles under the regulations
at 7 CFR part 340.
Environmental Issues for Consideration
We have also identified the following
potential environmental issues for
consideration in the EIS:
• Alteration in susceptibility to
disease or insects—Potential of FTE
lines 427 and 435 to harbor plant pests
or diseases and the impacts of these
pests or diseases on natural resources,
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13311
forestry, or agriculture within the range
of FTE lines 427 and 435.
• Alteration in weediness
characteristics—Potential of FTE lines
427 and 435 to be invasive in certain
environments and the impacts to natural
resources and sociocultural resources if
it is invasive.
• Potential impacts of growing FTE
lines 427 and 435 on soil hydrology and
water resources and how potential
changes in soil hydrology or water use
may affect natural resources and
sociocultural resources.
• Potential impacts of FTE lines 427
and 435 on fire incidence and ecology
and how this may affect natural
resources and sociocultural resources.
• Potential impacts of allelopathy of
FTE lines 427 and 435 on forestry
practices or land use.
• Potential direct or indirect effects of
FTE lines 427 and 435 on human health.
• Potential direct or indirect effects of
FTE lines 427 and 435 on wildlife and
their habitats.
In considering reasonable alternatives,
the EIS will also study whether these
potential environmental issues pose any
potential plant pest risks that FTE may
exhibit. In addition to plant pest risks
that may be posed by characteristics of
an individual GE eucalyptus, like
allelopathy (suppression of growth of
nearby plants due to toxin release), the
EIS will also examine potential plant
pest risks associated with
environmental issues arising from the
potential scale of nonregulated GE
eucalyptus plantings. Plantings under
the earlier permits were of small scale
and limited duration. A decision to
approve the petition would allow for
larger sized plantings, closer together,
over a longer period of time.
Additionally, it is the first time APHIS
has received a petition for deregulation
for a GE tree like eucalyptus, where the
species tends to be the dominant species
in many forest areas, and the engineered
change will increase the range of the
species. These changes in scope from
the small trials require analysis of the
potential environmental and plant pest
risk effects of large-scale FTE planting of
local hydrology, fire ecology, and other
potential issues discussed above.
While the EIS will consider a
comprehensive range of potential
environmental impacts that FTE
eucalyptus may cause, impacts that are
not plant pest risks will not affect
APHIS’ decision as to whether or not to
make a determination of nonregulated
status of FTE. As explained above,
under the PPA, APHIS must make a
determination of nonregulated status
based on the GE organism’s potential to
pose a plant pest risk and nothing more.
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Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices
Comments that identify other issues
or alternatives that should be
considered for examination in the EIS
would be especially helpful. All
comments received during the comment
period will be carefully considered in
developing the final scope of the EIS.
Upon completion of the draft EIS and
the plant pest risk assessment for FTE
lines 427 and 435, a notice announcing
their availability and an opportunity to
comment on them will be published in
the Federal Register.
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
February 2013.
Michael Gregoire,
Deputy Administrator, Biotechnology
Regulatory Services, Animal and Plant Health
Inspection Service.
[FR Doc. 2013–04519 Filed 2–26–13; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2012–0026]
Pioneer Hi-Bred International, Inc.;
Availability of Petition, Plant Pest Risk
Assessment, and Environmental
Assessment for Determination of
Nonregulated Status of Maize
Genetically Engineered for Herbicide
Tolerance and Insect Resistance
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
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AGENCY:
SUMMARY: We are advising the public
that the Animal and Plant Health
Inspection Service has received a
petition from Pioneer Hi-Bred
International, Inc., (Pioneer) seeking a
determination of nonregulated status of
maize designated as maize event DP–
;;4114–3, which has been genetically
engineered to be resistant to certain
lepidopteran and coleopteran pests and
tolerant to the herbicide glufosinate.
The petition has been submitted in
accordance with our regulations
concerning the introduction of certain
genetically engineered organisms and
products. We are soliciting comments
on whether this genetically engineered
maize is likely to pose a plant pest risk.
We are making available for public
comment the Pioneer petition, our plant
pest risk assessment, and our draft
environmental assessment for the
proposed determination of nonregulated
status.
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We will consider all comments
that we receive on or before April 29,
2013.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!documentDetail;D=APHIS-2012-00260001.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2012–0026, 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-2012-0026 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, draft environmental
assessment, and plant pest risk
assessment are also available on the
APHIS Web site at https://
www.aphis.usda.gov/brs/aphisdocs/
11_24401p.pdf, https://
www.aphis.usda.gov/brs/aphisdocs/
11_24401p _dea.pdf, and https://
www.aphis.usda.gov/brs/aphisdocs/
11_24401p _dpra.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 petition, draft
environmental assessment, or plant pest
risk assessment, contact Ms. Cindy Eck
at (301) 851–3892, email:
cynthia.a.eck@aphis.usda.gov.
SUPPLEMENTARY INFORMATION:
DATES:
Background
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
PO 00000
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Fmt 4703
Sfmt 4703
there is reason to believe are plant pests.
Such genetically engineered 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 11–244–01p) from
Pioneer Hi-Bred International, Inc.,
(Pioneer) of Johnston, IA, seeking a
determination of nonregulated status of
maize (Zea mays) designated as maize
event DP–;;4114–3 (event 4114). Event
4114 has been genetically engineered to
be resistant to certain lepidopteran
pests, including European corn borer
(Ostrinia nubilalis), and certain
coleopteran pests, including western
corn rootworm (Diabrotica virgifera
virgifera), and tolerant to the herbicide
glufosinate. The petition states that this
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.
As described in the petition, event
4114 has been genetically engineered to
produce the Cry proteins Cry1F,
Cry34Ab1, and Cry35Ab1, as well as the
herbicide tolerance protein
phosphinothricin acetyltransferase
(PAT). The Cry1F protein confers
resistance to certain lepidopteran pests,
including European corn borer; the
Cry34Ab1 and Cry35Ab1 proteins
confers resistance to certain coleopteran
pests, including the western corn
rootworm; and the PAT protein confers
tolerance to the herbicidal active
ingredient glufosinate-ammonium at
current labeled rates. Event 4114 is
currently regulated under 7 CFR part
340. Interstate movements and field
tests of event 4114 have been conducted
under permits issued or notifications
acknowledged 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 test. 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.
In section 403 of the Plant Protection
Act, ‘‘plant pest’’ is defined as any
E:\FR\FM\27FEN1.SGM
27FEN1
]]>Agencies
[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13309-13312]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04519]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2012-0030]
ArborGen Inc.; Availability of Petition, Notice of Intent To
Prepare an Environmental Impact Statement for Determination of
Nonregulated Status of Freeze Tolerant Eucalyptus Lines, and Notice of
Virtual Public Meetings
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has received a petition from ArborGen Inc. seeking a
determination of nonregulated status of Freeze Tolerant Eucalyptus
lines designated 427 and 435, which have been genetically engineered
(GE) to be more tolerant of cold conditions. The incorporation of the
GE trait allows these eucalyptus hybrid trees to be grown in a broader
geographic area than non-GE eucalyptus hybrid trees. The petition has
been submitted in accordance with our regulations concerning the
introduction of certain
[[Page 13310]]
GE organisms and products. We are making available for public comment
the ArborGen Inc. petition and are soliciting comments on whether these
GE eucalyptus lines are likely to pose a plant pest risk. We are also
announcing to the public our intent to prepare an environmental impact
statement (EIS) on the action with regard to the petition for
nonregulated status, identifying potential issues and alternatives that
may be studied in the EIS, and requesting public comments to further
delineate the scope of the alternatives and environmental impacts and
issues. We are also announcing that APHIS will be hosting two virtual
meetings during the comment period. The purpose of the meetings will be
to further delineate the scope of alternatives and environmental
impacts and issues discussed in the EIS.
DATES: We will consider all comments that we receive on or before April
29, 2013. We will also consider comments made at virtual public
meetings that will be held during the comment period.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/#!documentDetail;D=APHIS-2012-0030-0001.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2012-0030, 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-2012-
0030 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.
The petition is also available on the APHIS Web site at https://www.aphis.usda.gov/brs/aphisdocs/11_01901p.pdf.
Other Information: Details regarding the virtual meetings,
including times, dates, and how to participate, will be available at
https://www.aphisvirtualmeetings.com.
FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director,
Environmental Risk Analysis Programs, Biotechnology Regulatory
Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1238;
(301) 851-3954. To obtain copies of the petition, contact Ms. Cindy Eck
at (301) 851-851-3882, email: cynthia.a.eck@aphis.usda.gov.
SUPPLEMENTARY INFORMATION:
Background
Under the authority of the plant pest provisions of the Plant
Protection Act (PPA) (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.
Proposed Action
APHIS has received a petition (APHIS Petition Number 11-019-01p)
from ArborGen Inc. of Summerville, SC, seeking a determination of
nonregulated status of two Freeze Tolerant Eucalyptus (FTE) lines
designated 427 and 435. The petition states that these eucalyptus trees
are unlikely to pose a plant pest risk and, therefore, should not be a
regulated article under APHIS' regulations in 7 CFR part 340. These
regulations are authorized by the PPA to prevent the introduction or
dissemination of plant pests, and the decision on whether or not to
grant the petition will be based on this standard.
As described in the petition, FTE lines 427 and 435 have been
genetically engineered to express the CBF2 gene to be more tolerant of
cold conditions and a gene expression cassette that prevents pollen
development. FTE lines 427 and 435 are currently regulated under 7 CFR
part 340. Field tests of FTE lines 427 and 435 have been conducted
under permits issued by APHIS at multiple sites representing both
freeze stress and freeze stress-free environments in the southeastern
United States, Alabama, Florida, Georgia, Louisiana, Mississippi, South
Carolina, and Texas.
APHIS has conducted three separate environmental assessments (EA)
on actions related to permitting confined field releases of FTE trees
under conditions designed to prevent spread of the trees outside the
field test area, and in each case announced the availability of the EA
in the Federal Register. These notices \1\ were published on April 20,
2007 (Docket No. APHIS-2007-0027, 72 FR 19876-19877), June 3, 2009
(Docket No. APHIS-2008-0059, 74 FR 26648-26649), and February 10, 2012
(Docket No. APHIS-2011-0130; 77 FR 7123-7124). In these assessments,
APHIS concluded that the field trials would not pose a plant pest risk
and that issuing permits for the field trials would not significantly
affect the quality of the human environment.
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\1\ The notices and environmental assessments are available at
https://www.regulations.gov/#!docketDetail;D=APHIS-2007-0027, https://www.regulations.gov/#!docketDetail;D=APHIS-2008-0059, and https://www.regulations.gov/#!docketDetail;D=APHIS-2011-0130.
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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 copies 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. All comments received will be available for public review.
Any substantive issues identified by APHIS based on our review of the
petition and our evaluation and analysis of the 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 EA or an environmental impact statement
(EIS)--in accordance with the National Environmental Policy Act of
1969, as amended (42 U.S.C. 4321 et seq.) (NEPA), to provide the Agency
with a review and analysis of any potential environmental impacts
associated with the petition request. Upon completion of these
documents, APHIS will furnish
[[Page 13311]]
a response to the petitioner and will notify the public of our
regulatory determination.
Under the provisions of NEPA, Federal agencies must examine the
potential environmental impacts of proposed Federal actions before
actions are taken. In accordance with NEPA, regulations of the Council
on Environmental Quality for implementing the procedural provisions of
NEPA (40 CFR parts 1500-1508), U.S. Department of Agriculture (USDA)
regulations implementing NEPA (7 CFR part 1b) and APHIS' NEPA
Implementing Procedures (7 CFR part 372), APHIS has considered how to
properly examine these potential environmental impacts. In each of the
previous three APHIS actions concerning FTE trees, we determined that
an EA was the appropriate means to consider and document environmental
impacts. Also, in response to a legal challenge to the adequacy of
these EAs and the NEPA process, the United States District Court for
the Southern District of Florida granted summary judgment affirming the
APHIS actions (Case No. 10-14175-ClV-MOORE/LYNCH).
An EA might also be used in this case, where the relevant Federal
action would be determination of nonregulated status of two FTE lines.
However, APHIS is choosing the option of preparing an EIS to analyze
the potential environmental impacts of responding to this petition
request.
APHIS is exercising its option to prepare an EIS rather than an EA
to address unresolved proposed or adopted local, regional, State,
interstate, or Federal land use plans or policies that may result in
adverse environmental impacts. In preparing an EIS, APHIS would be
responsive to other agencies that have an interest in the possible
future establishment of FTE trees in forest areas. Federal and State
agencies have expressed interest in this issue from several
perspectives. The USDA Forest Service has agreed to serve as a
cooperating agency in the preparation of this EIS and will provide
expertise in hydrology, to assess the effects of eucalyptus on water
resources, and economic modeling, to predict where in the United States
FTE trees may be adopted. The United States Department of Energy
considers eucalyptus as a candidate bioenergy feedstock. The United
States Fish and Wildlife Service has expressed interest in studies of
the impacts of eucalyptus tree plantations on wildlife diversity and
ecosystem sustainability. Various States, including Georgia and
Florida, have conducted studies or hearings on the possible use of tree
plantations as sources of bioenergy feedstocks. APHIS believes that
choosing to prepare an EIS rather than an EA would allow us to fully
consider potential environmental impacts of the Federal action under
consideration and would also provide, in an efficient way, data that
could address a wide variety of government interests and could shed
light on issues relevant to possible future actions under the
jurisdiction of interested agencies. By preparing an EIS at this time,
APHIS may provide agencies with an opportunity to adopt all or part of
the EIS for future actions in accordance with the adoption provisions
of the Council on Environmental Quality's NEPA implementing regulations
(40 CFR 1506.3).
Alternatives
This notice identifies reasonable alternatives and potential issues
that may be studied in the EIS. We are requesting public comments to
further delineate the scope of alternatives and environmental impacts
and issues. We will be hosting two virtual meetings during the comment
period to discuss the scope of the EIS (see ADDRESSES above). 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.
The EIS will consider a range of reasonable alternatives. APHIS is
considering including a ``no action'' and ``approve the petition
request'' alternatives. Under the ''no action'' alternative, in
accordance with 7 CFR part 340, FTE would continue to be regulated and
the environmental release and interstate movement of FTE lines 427 and
435 would require permits issued or notifications acknowledged by
APHIS. APHIS might choose this alternative if there was insufficient
evidence to demonstrate that the regulated eucalyptus events were not
plant pests or the lack of plant pest risk from the unconfined
cultivation of FTE lines 427 and 435. Under the ``approve the petition
request'' alternative, FTE lines 427 and 435 would no longer be
regulated articles under the regulations at 7 CFR part 340.
Environmental Issues for Consideration
We have also identified the following potential environmental
issues for consideration in the EIS:
Alteration in susceptibility to disease or insects--
Potential of FTE lines 427 and 435 to harbor plant pests or diseases
and the impacts of these pests or diseases on natural resources,
forestry, or agriculture within the range of FTE lines 427 and 435.
Alteration in weediness characteristics--Potential of FTE
lines 427 and 435 to be invasive in certain environments and the
impacts to natural resources and sociocultural resources if it is
invasive.
Potential impacts of growing FTE lines 427 and 435 on soil
hydrology and water resources and how potential changes in soil
hydrology or water use may affect natural resources and sociocultural
resources.
Potential impacts of FTE lines 427 and 435 on fire
incidence and ecology and how this may affect natural resources and
sociocultural resources.
Potential impacts of allelopathy of FTE lines 427 and 435
on forestry practices or land use.
Potential direct or indirect effects of FTE lines 427 and
435 on human health.
Potential direct or indirect effects of FTE lines 427 and
435 on wildlife and their habitats.
In considering reasonable alternatives, the EIS will also study
whether these potential environmental issues pose any potential plant
pest risks that FTE may exhibit. In addition to plant pest risks that
may be posed by characteristics of an individual GE eucalyptus, like
allelopathy (suppression of growth of nearby plants due to toxin
release), the EIS will also examine potential plant pest risks
associated with environmental issues arising from the potential scale
of nonregulated GE eucalyptus plantings. Plantings under the earlier
permits were of small scale and limited duration. A decision to approve
the petition would allow for larger sized plantings, closer together,
over a longer period of time. Additionally, it is the first time APHIS
has received a petition for deregulation for a GE tree like eucalyptus,
where the species tends to be the dominant species in many forest
areas, and the engineered change will increase the range of the
species. These changes in scope from the small trials require analysis
of the potential environmental and plant pest risk effects of large-
scale FTE planting of local hydrology, fire ecology, and other
potential issues discussed above.
While the EIS will consider a comprehensive range of potential
environmental impacts that FTE eucalyptus may cause, impacts that are
not plant pest risks will not affect APHIS' decision as to whether or
not to make a determination of nonregulated status of FTE. As explained
above, under the PPA, APHIS must make a determination of nonregulated
status based on the GE organism's potential to pose a plant pest risk
and nothing more.
[[Page 13312]]
Comments that identify other issues or alternatives that should be
considered for examination in the EIS would be especially helpful. All
comments received during the comment period will be carefully
considered in developing the final scope of the EIS. Upon completion of
the draft EIS and the plant pest risk assessment for FTE lines 427 and
435, a notice announcing their availability and an opportunity to
comment on them will be published in the Federal Register.
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 February 2013.
Michael Gregoire,
Deputy Administrator, Biotechnology Regulatory Services, Animal and
Plant Health Inspection Service.
[FR Doc. 2013-04519 Filed 2-26-13; 8:45 am]
BILLING CODE 3410-34-P
