[Federal Register Volume 79, Number 217 (Monday, November 10, 2014)]
[Notices]
[Pages 66688-66689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26593]
[[Page 66688]]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2012-0067]
J.R. Simplot Co.; Determination of Nonregulated Status of Potato
Genetically Engineered for Low Acrylamide Potential and Reduced Black
Spot Bruise
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public of our determination that potatoes
designated as InnateTM potatoes (events E12, E24, F10, F37,
J3, J55, J78, G11, H37, and H50), which have been genetically
engineered for low acrylamide potential (acrylamide is a human
neurotoxicant and potential carcinogen that may form in potatoes and
other starchy foods under certain cooking conditions) and reduced black
spot bruise, are 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 November 10, 2014.
ADDRESSES: You may read the documents referenced in this notice and the
comments we received at http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0067 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 13-022-01p.
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
13-022-01p) from J.R. Simplot Company (Simplot) of Boise, ID, seeking a
determination of nonregulated status of potatoes (Solanum tuberosum)
designated as InnateTM potatoes (events E12, E24, F10, F37,
J3, J55, J78, G11, H37, and H50), which have been genetically
engineered for low acrylamide potential and reduced black spot bruise.
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 May 3, 2013 (78 FR 25942-25943, Docket No. APHIS-2012-
0067), APHIS announced the availability of the Simplot petition for
public comment. APHIS solicited comments on the petition for 60 days
ending on July 2, 2013, 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-2012-0067.
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APHIS received 308 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 41,475
comments. Issues raised during the comment period include concerns
regarding potential effects on conventional potato production, export
markets, and plant fitness. 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 plant 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 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 and a PPRA from May 30,
2014, to June 30, 2014. APHIS solicited comments on the draft EA, the
PPRA, and whether the subject potatoes are likely to pose a plant pest
risk. APHIS received 60 comments during the comment period. The
majority of comments expressed general opposition to APHIS making a
determination of
[[Page 66689]]
nonregulated status of GE organisms. Issues raised during the comment
period included concerns regarding the potential transfer of genes from
GE to non-GE potatoes and potential 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.
APHIS received additional information from Simplot on the molecular
characterization of one of the events, J3, after publication of the
petition, PPRA, and draft EA. The new information indicates rearranged
repeated sequences of the inserted genetic material at the right
border. APHIS has reviewed the revised structure and concluded the
revision does not change the analyses or conclusions in either the PPRA
or the EA because there are no new sequences present that were not
previously described, no new insertion site(s), and no expected change
in functionality. The updated characterization of J3 has been appended
to the petition as Appendix 11.
National Environmental Policy Act
After reviewing and evaluating the comments received during the
comment period on the draft EA and 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 potatoes. 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 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
InnateTM potatoes are unlikely to pose a plant pest risk and
therefore are 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 3rd day of November 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-26593 Filed 11-7-14; 8:45 am]
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