80 FR 76261 - J.R. Simplot Company; Availability of Preliminary Finding of No Significant Impact, Similarity Assessment, and Preliminary Decision for an Extension of a Determination of Nonregulated Status to V11 Snowden Potatoes With Low Acrylamide Potential and Reduced Black Spot Bruise

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 235 (December 8, 2015)

We are advising the public that the Animal and Plant Health Inspection Service has reached a preliminary decision to extend our determination of nonregulated status of Innate\TM\ potato to Snowden potato variety event SPS-00V11-6 (hereinafter V11 potato) in response to a request from the J.R. Simplot Company. V11 potato has been genetically engineered to exhibit low acrylamide potential in cooked potatoes and reduced black spot bruise. We are making available for public comment our preliminary finding of no significant impact, our similarity assessment, and our preliminary extended determination of nonregulated status.

[Federal Register Volume 80, Number 235 (Tuesday, December 8, 2015)]
[Notices]
[Pages 76261-76263]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-30878]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2015-0088]


J.R. Simplot Company; Availability of Preliminary Finding of No 
Significant Impact, Similarity Assessment, and Preliminary Decision for 
an Extension of a Determination of Nonregulated Status to V11 Snowden 
Potatoes With 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 that the Animal and Plant Health 
Inspection Service has reached a preliminary decision to extend our 
determination of nonregulated status of Innate\TM\ potato to Snowden 
potato variety event SPS-00V11-6 (hereinafter V11 potato) in response 
to a request from the J.R. Simplot Company. V11 potato has been 
genetically engineered to exhibit low acrylamide potential in cooked 
potatoes and reduced black spot bruise. We are making available for 
public comment our preliminary finding of no significant impact, our 
similarity assessment, and our preliminary extended determination of 
nonregulated status.

DATES: We will consider all comments that we receive on or before 
January 7, 2016.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0088.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2015-0088, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    The J.R. Simplot Company extension request, our preliminary finding 
of no significant impact, our similarity assessment, our preliminary 
determination, and any comments we receive on this docket may be viewed 
at http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0088 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 and any comments we received regarding our 
determination of nonregulated status of the antecedent organisms 
(Innate\TM\ Potato events E12, F10, and J3), can be found at http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0067. Supporting 
documents may also be found on the APHIS Web site for V11 potato (the 
organism under evaluation) under APHIS Petition Number 15-140-01p, and 
the antecedent organisms (Innate\TM\ Potato events E12, F10, and J3) 
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, contact Ms. Cindy Eck at (301) 851-3885, 
email: [email protected].

SUPPLEMENTARY INFORMATION: 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

[[Page 76262]]

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 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. Further, the regulations in Sec.  340.6(e)(2) 
provide that a person may request that APHIS extend a determination of 
nonregulated status to other organisms. Such a request must include 
information to establish the similarity of the antecedent organism and 
the regulated article in question.
    In a notice \1\ published in the Federal Register on November 10, 
2014 (79 FR 66688-66689, Docket No. APHIS-2012-0067), APHIS announced 
our 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. APHIS has received a request for an extension of a 
determination of nonregulated status of InnateTM potatoes 
(APHIS Petition Number 13-022-01p) to Snowden potato variety event SPS-
00V11-6 (hereinafter V11 potato) (APHIS Petition Number 15-140-01p) 
from the J.R. Simplot Company (Simplot) of Boise, ID. In the extension 
request, Simplot named three of the ten previously deregulated events 
as antecedents. Like the antecedents, V11 potato has been genetically 
engineered for low acrylamide potential and reduced black spot bruise. 
In its request, Simplot stated that V11 potato was produced by 
transforming an additional variety of potato, Snowden, using the same 
DNA and method that was used for the antecedent potatoes and, based on 
the similarity, is unlikely to pose a plant pest risk. Therefore, the 
request stated that V11 potato should not be a regulated article under 
APHIS' regulations in 7 CFR part 340.
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    \1\ To view the notice, our determination, supporting documents, 
and the comments we have received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0067.
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    As described in the extension request, V11 potato has been 
genetically engineered through the insertion of genetic elements from 
potato or wild potato (a group of related plant species that are 
sexually compatible with potato) using Simplot's InnateTM 
technologies. APHIS has previously assessed the risks associated with 
the insertion of these same genetic elements into potato and concluded 
that the resulting organisms did not pose a plant pest risk. Based on 
the information in the request, we have concluded that V11 potato is 
similar to the antecedent potatoes. V11 potato is currently regulated 
under 7 CFR part 340.
    In section 403 of the PPA, ``plant pest'' is defined as any living 
stage of any of the following that can directly or indirectly injure, 
cause damage to, or cause disease in any plant product: A protozoan, a 
nonhuman animal, a parasitic plant, a bacterium, a fungus, a virus or 
viroid, an infectious agent or other pathogen, or any article similar 
to or allied with any of the foregoing. APHIS completed a plant pest 
risk assessment (PPRA) and an environmental assessment (EA) for the 
antecedent organisms. Based on those assessments, we concluded that the 
antecedent organisms are unlikely to present a plant pest risk. V11 
potato expresses the same low acrylamide potential and reduced black 
spot bruise prevalence as the antecedent potatoes. Therefore, based on 
our PPRA for the antecedents and the similarity between V11 potato and 
the antecedents, APHIS has concluded that V11 potato is unlikely to 
pose a plant pest risk.
    The EA for the antecedent organisms was prepared using data 
submitted by Simplot, a review of other scientific data, and field 
tests conducted under APHIS oversight. The EA was prepared to provide 
the APHIS decisionmaker with a review and analysis of any potential 
environmental impacts associated with the proposed determination of 
nonregulated status of the antecedent potatoes. The EA was prepared in 
accordance with (1) the National Environmental Policy Act of 1969 
(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 the similarity of V11 potato to the antecedent potatoes, 
APHIS has prepared a preliminary finding of no significant impact 
(FONSI) on V11 potato using the EA prepared for InnateTM 
potato. APHIS considered the following alternatives: (1) Take no 
action, i.e., APHIS would not change the regulatory status of V11 
potato and it would continue to be a regulated article, or (2) make a 
determination of nonregulated status of V11 potato. APHIS' preferred 
alternative is to make a determination of nonregulated status of V11 
potato.
    APHIS has carefully examined the existing NEPA documentation 
completed for InnateTM potato and has concluded that 
Simplot's request to extend a determination of nonregulated status to 
V11 potato encompasses the same scope of environmental analysis as the 
antecedent potatoes.
    Based on APHIS' analysis of information submitted by Simplot, 
references provided in the extension request, peer-reviewed 
publications, information analyzed in the EA, and the similarity of V11 
potato to the antecedent organisms, APHIS has determined that V11 
potato is unlikely to pose a plant pest risk. We have therefore reached 
a preliminary decision to approve the request to extend the 
determination of nonregulated status of InnateTM potato to 
V11 potato, whereby V11 potato would no longer be subject to our 
regulations governing the introduction of certain genetically 
engineered organisms.
    Paragraph (e) of Sec.  340.6 provides that APHIS will publish a 
notice in the Federal Register announcing all preliminary decisions to 
extend determinations of nonregulated status for 30 days before the 
decisions become final and effective. In accordance with Sec.  340.6(e) 
of the regulations, we are publishing this notice to inform the public 
of our preliminary decision to extend the determination of nonregulated 
status of the antecedent potatoes to V11 potato.
    APHIS will accept written comments on the FONSI regarding a 
determination of nonregulated status of V11 potato for a period of 30 
days from the date this notice is published in the Federal Register. 
The FONSI, as well as the extension request, supporting documents, and 
our preliminary determination for V11 potato, are available for public 
review as indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT 
above. Copies of these documents may also be obtained by contacting the 
person listed under FOR FURTHER INFORMATION CONTACT.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. All comments will be available for public review. After 
reviewing and evaluating

[[Page 76263]]

the comments, if APHIS determines that no substantive information has 
been received that would warrant APHIS altering its preliminary 
regulatory determination or FONSI, our preliminary regulatory 
determination will become final and effective upon notification of the 
public through an announcement on our Web site at  http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml. APHIS 
will also furnish a response to the petitioner regarding our final 
regulatory determination. No further Federal Register notice will be 
published announcing the final regulatory determination regarding V11 
potato.

    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 2nd day of December 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-30878 Filed 12-7-15; 8:45 am]
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