[Federal Register Volume 80, Number 170 (Wednesday, September 2, 2015)]
[Notices]
[Pages 53101-53102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21747]
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Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
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Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 /
Notices
[[Page 53101]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2014-0076]
J.R. Simplot Co.; Determination of Nonregulated Status of Potato
Genetically Engineered for Late Blight Resistance, Low Acrylamide
Potential, Reduced Black Spot Bruising, and Lowered Reducing Sugars
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public of our determination that
Innate\TM\ Potato designated as Russet Burbank event W8, which has been
genetically engineered for late blight resistance, low acrylamide
potential, reduced black spot bruising, and lowered reducing sugars, is
no longer considered a regulated article under our regulations
governing the introduction of certain genetically engineered organisms.
Our determination is based on our evaluation of data submitted by J.R.
Simplot Company, in its petition for a determination of nonregulated
status, our analysis of available scientific data, and comments
received from the public in response to our previous notices announcing
the availability of the petition for nonregulated status and its
associated environmental assessment and plant pest risk assessment.
This notice also announces the availability of our written
determination and finding of no significant impact.
DATES: Effective September 2, 2015.
ADDRESSES: You may read the documents referenced in this notice and the
comments we received at http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0076 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.
Supporting documents are also available on the APHIS Web site at
http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml
under APHIS Petition Number 14-093-01p.
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: [email protected]. To obtain copies
of the supporting documents for this petition, contact Ms. Cindy Eck at
(301) 851-3892, email: [email protected].
SUPPLEMENTARY INFORMATION: 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
14-093-01p) from J.R. Simplot Company (Simplot) of Boise, ID, seeking a
determination of nonregulated status of potatoes (Solanum tuberosum)
designated as Innate\TM\ W8, which have been genetically engineered for
late blight resistance, to express low acrylamide potential, reduced
black spot bruising, and lowered reducing sugars. Acrylamide is a human
neurotoxicant and potential carcinogen that may form in potatoes and
other starchy foods under certain cooking conditions. The petition
states that these potatoes are unlikely to pose a plant pest risk 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 November 10, 2014 (79 FR 66689-66690, Docket No. APHIS-
2014-0076), APHIS announced the availability of the Simplot petition
for public comment. APHIS solicited comments on the petition for 60
days ending on January 9, 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.
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\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
http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
\2\ To view the notice, the petition, the comments we received,
and other supporting documents, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0076.
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APHIS received 130 comments on the petition; one of these comments
included electronic attachments consisting of a consolidated document
of many identical or nearly identical letters, for a total of 22,673
comments. Issues raised during the comment period include contamination
of conventional potato production, the potential for disruption of
trade due to the presence of unwanted genetically engineered
commodities in exports, the need for more research prior to approval of
the petition, the potential for negative impacts to plant fitness and
the environment, and human health concerns. APHIS decided, based on its
review of the petition and its evaluation and analysis of the comments
received during the 60-day public comment period on the petition, that
the petition involves a GE organism that raises substantive new issues.
According to our public review process for such petitions (see footnote
1), APHIS first solicits written comments from the public on a draft
environmental assessment (EA) and a preliminary plant
[[Page 53102]]
pest risk assessment (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 the preliminary PPRA and
other information, APHIS revises the PPRA as necessary and prepares a
final EA and, based on the final EA, a National Environmental Policy
Act (NEPA) decision document (either a finding of no significant impact
(FONSI) or a notice of intent to prepare an environmental impact
statement). If a FONSI is reached, APHIS furnishes a response to the
petitioner, either approving or denying the petition. APHIS also
publishes a notice in the Federal Register announcing the regulatory
status of the GE organism and the availability of APHIS' final EA,
PPRA, FONSI, and our regulatory determination.
APHIS sought public comment on a draft EA, a preliminary PPRA, and
whether the subject potatoes are likely to pose a plant pest risk from
May 5, 2015, to June 4, 2015.\3\ APHIS received 24 comments on the
petition. Nineteen comments supported the determination of nonregulated
status, and five comments did not support the determination of
nonregulated status. The majority of the comments opposing the
determination expressed general opposition to APHIS making a
determination of nonregulated status of GE organisms. Issues raised
during the comment period included concerns regarding the potential for
disruption of trade and potential human health and environmental
impacts. APHIS has addressed the issues raised during the comment
period and has provided responses to comments as an attachment to the
FONSI.
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\3\ 80 FR 25660-25661.
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National Environmental Policy Act
After reviewing and evaluating the comments received during the
comment period on the draft EA and preliminary PPRA and other
information, APHIS has prepared a final EA. The EA has been prepared to
provide the public with documentation of APHIS' review and analysis of
any potential environmental impacts associated with the determination
of nonregulated status of Simplot's InnateTM W8 potato. The
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 EA,
the response to public comments, and other pertinent scientific data,
APHIS has reached a FONSI with regard to the preferred alternative
identified in the EA (to make a determination of nonregulated status of
InnateTM W8 potatoes).
Determination
Based on APHIS' analysis of field and laboratory data submitted by
Simplot, references provided in the petition, peer-reviewed
publications, information analyzed in the EA, the PPRA, comments
provided by the public, and information provided in APHIS' response to
those public comments, APHIS has determined that Simplot's Innate\TM\
Potato designated as Russet Burbank event W8 is unlikely to pose a
plant pest risk and therefore is no longer subject to our regulations
governing the introduction of certain GE organisms.
Copies of the signed determination document, PPRA, final EA, FONSI,
and response to comments, as well as the previously published petition
and supporting documents, are available as indicated in the ADDRESSES
and FOR FURTHER INFORMATION CONTACT sections of this notice.
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 28th day of August 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-21747 Filed 9-1-15; 8:45 am]
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