[Federal Register Volume 81, Number 185 (Friday, September 23, 2016)]
[Notices]
[Pages 65622-65623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22928]


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 Notices
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
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  Federal Register / Vol. 81, No. 185 / Friday, September 23, 2016 / 
Notices  

[[Page 65622]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2016-0057]


J.R. Simplot Company; Availability of Preliminary Finding of No 
Significant Impact, Preliminary Plant Pest Risk Similarity Assessment, 
and Preliminary Determination for an Extension of a Determination of 
Nonregulated Status for X17 and Y9 Potato Varieties

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 J.R. Simplot Company's 
(Simplot) InnateTM Potato designated as Russet Burbank event 
W8 (the antecedent potato event) to Simplot's Ranger Russet variety 
(X17) and Atlantic variety (Y9) potatoes. Simplot's X17 and Y9 potatoes 
have been genetically engineered for late blight resistance, low 
acrylamide potential, lowered reducing sugars, and reduced black spot 
using the same genetic constructs used to transform the antecedent 
potato event. We are making available for public comment our 
preliminary determination, preliminary plant pest risk similarity 
assessment, and preliminary finding of no significant impact for the 
proposed determination of nonregulated status.

DATES: We will consider all comments that we receive on or before 
October 24, 2016.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2016-0057.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2016-0057, 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 
determination, preliminary plant pest risk similarity assessment, 
preliminary finding of no significant impact, and any comments we 
receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2016-0057 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 organism (potato 
event W8) can be found at http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0076. Supporting documents may also be 
found on the APHIS Web site for X17 and Y9 (the organisms under 
evaluation) under APHIS Petition Number 16-064-01p, and the antecedent 
organism (potato event W8) under APHIS Petition Number 14-093-01p.

FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director, 
Biotechnology 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 
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 September 2, 
2015 (80 FR 53101-53102, Docket No. APHIS-2014-0076), APHIS announced 
our determination of nonregulated status of the J.R. Simplot Company's 
(Simplot) InnateTM 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. APHIS has received a request from Simplot for an 
extension of that determination of nonregulated status to its Ranger 
Russet variety (X17) and Atlantic variety (Y9) potatoes (APHIS Petition 
Number 16-064-01p). In the extension request, Simplot named the 
previously deregulated W8 potato event as the antecedent organism. Like 
the antecedent, X17 and Y9 are genetically engineered for late blight 
resistance, low acrylamide potential, reduced black spot bruising, and 
lowered reducing sugars. In its request, Simplot stated that X17 and Y9 
potatoes were produced by using the same genetic construct that was 
used to transform the antecedent potato and, based on the similarity, 
is unlikely to pose a plant pest risk. Therefore, the request stated 
that X17 and Y9 potatoes should not be regulated articles 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=2014=0076.
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    As part of our decisionmaking process regarding a genetically 
engineered organism's regulatory status, APHIS evaluates the plant pest 
risk of the regulated article. In section 403 of the

[[Page 65623]]

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.
    As described in the extension request, X17 and Y9 potatoes have 
been genetically engineered through the insertion of genetic elements 
from plant pest organisms listed in 7 CFR 340.2. APHIS previously 
completed a plant pest risk assessment (PPRA) associated with the 
insertion of these same genetic elements into potatoes during the 
review of the antecedent variety, InnateTM Russet Burbank 
event W8 potato, and concluded that the resulting organisms did not 
pose a plant pest risk.
    X17 and Y9 potatoes express the same resistance for late blight 
resistance, low acrylamide potential, reduced black spot bruising, and 
lowered reducing sugars as the antecedent potato. APHIS prepared a 
plant pest risk similarity assessment (PPRSA) to compare X17 and Y9 
potatoes to the antecedent. As described in the PPRSA, X17 and Y9 
potatoes were obtained by introducing the same construct used to 
produce InnateTM Russet Burbank event W8 into the Ranger 
Russet variety (X17) and Atlantic variety (Y9). Based on our PPRA for 
the antecedent and the similarity between X17 and Y9 potatoes and the 
antecedent based on the PPRSA, APHIS has concluded that X17 and Y9 
potatoes are unlikely to pose a plant pest risk.
    The environmental assessment (EA) for the antecedent organism 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 potato. 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 X17 and Y9 potatoes to the antecedent 
potato, APHIS has prepared a preliminary finding of no significant 
impact (FONSI) on X17 and Y9 potatoes using the EA prepared for W8 
potato. APHIS considered the following alternatives: (1) Take no 
action, i.e., APHIS would not change the regulatory status of X17 or Y9 
potatoes and it would continue to be a regulated article, or (2) make a 
determination of nonregulated status of X17 and Y9 potatoes. APHIS' 
preferred alternative is to make a determination of nonregulated status 
of X17 and Y9 potatoes.
    APHIS has carefully examined the existing NEPA documentation 
completed for W8 potato and has concluded that Simplot's request to 
extend a determination of nonregulated status to X17 and Y9 potatoes 
encompasses the same scope of environmental analysis as the antecedent 
potato.
    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 X17 
and Y9 potatoes to the antecedent organisms, APHIS has determined that 
X17 and Y9 potatoes are 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 W8 potato to X17 and 
Y9 potatoes, whereby X17 and Y9 potatoes 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 potato to X17 and Y9 potatoes.
    APHIS will accept written comments on its preliminary determination 
and the preliminary FONSI regarding a determination of nonregulated 
status of X17 and Y9 potatoes for a period of 30 days from the date 
this notice is published in the Federal Register. The preliminary 
FONSI, as well as the extension request, supporting documents, and our 
preliminary determination for X17 and Y9 potatoes, 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 the comments, if APHIS determines that no new 
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 
X17 and Y9 potatoes.

    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 19th day of September 2016.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-22928 Filed 9-22-16; 8:45 am]
 BILLING CODE 3410-34-P