[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13309-13312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04519]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 http://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 http://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 http://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
http://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: [email protected].
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.
---------------------------------------------------------------------------
\1\ The notices and environmental assessments are available at
http://www.regulations.gov/#!docketDetail;D=APHIS-2007-0027, http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0059, and http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0130.
---------------------------------------------------------------------------
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