[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]


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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 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.
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    \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.
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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]
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