[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]
BILLING CODE 3410-34-P