[Federal Register Volume 85, Number 123 (Thursday, June 25, 2020)]
[Notices]
[Pages 38110-38111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13711]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2020-0048]


J.R. Simplot Company; Availability of a Request and Plant Pest 
Risk Similarity Assessment for an Extension of a Determination of 
Nonregulated Status for Z6 Potatoes With Late Blight Protection, Low 
Acrylamide Potential, Lowered Reducing Sugars, and Reduced Black Spot

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 received a request to extend our determination 
of nonregulated status of J.R. Simplot Company's (Simplot's) W8 potato 
to event Z6 (hereafter Z6 potato). Z6 potato has been genetically 
engineered for late blight protection, low acrylamide potential, 
lowered reducing sugars, and reduced black spot using the same 
construct and method of transformation as W8 potato. We are making 
available for public comment the request and our plant pest risk 
similarity assessment and preliminary determination of nonregulated 
status.

DATES: We will consider all comments that we receive on or before July 
27, 2020.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2020-0048.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2020-0048, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
    The Simplot extension request, our plant pest risk similarity 
assessment and preliminary determination of nonregulated status, and 
any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2020-0048 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.

FOR FURTHER INFORMATION CONTACT: Ms. Cindy Eck, Biotechnology 
Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 
20737-1236; (301) 851-3892, 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 (GE) 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.
    On September 2, 2015,\1\ APHIS announced its determination of 
nonregulated status of J.R. Simplot Company's (Simplot's) W8 potato 
(Solanum tuberosum), which was genetically engineered for late blight 
protection, low acrylamide potential, lowered reducing sugars, and 
reduced black spot. APHIS has received a request for an extension of 
that determination of nonregulated status of W8 potato to potato 
designated as event Z6 (APHIS Petition Number 19_099-02p), also from 
Simplot. Z6 potato also expresses late blight protection, low 
acrylamide potential, lowered reducing sugars, and reduced black spot. 
In its request, Simplot stated that this potato is similar to the 
antecedent organism W8 potato and, based on the similarity to the 
antecedent organism, is unlikely to pose a plant pest risk and, 
therefore, should not be a regulated article under APHIS' regulations 
in 7 CFR part 340.
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    \1\ https://www.regulations.gov/document?D=APHIS-2014-0076-0160.
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    As described in the extension request, Z6 potato was developed 
using the same constructs and method of transformation as W8 potato. 
Based on the information in the request, we have concluded that Z6 
potato is similar to W8 potato. Z6 potato is currently regulated under 
7 CFR part 340.
    As part of our decisionmaking process regarding a GE organism's 
regulatory status, APHIS evaluates the plant pest risk of the article. 
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.

[[Page 38111]]

    APHIS has prepared a plant pest risk similarity assessment (PPRSA) 
to compare Z6 potato to the antecedent. As described in the PPRSA, the 
same genetic constructs used in W8 potato were previously used in Z6 
potato, and APHIS has concluded that W8 potato is unlikely to pose a 
plant health risk. Therefore, based on the similarity between Z6 potato 
and W8 potato as described in the PPRSA, APHIS has concluded that Z6 
potato is no more likely to pose a plant pest risk than W8 potato.
    APHIS has analyzed information submitted by Simplot, references 
provided in the extension request, peer-reviewed publications, and 
supporting documentation prepared for the antecedent organism. Based on 
APHIS' analysis of this information and the similarity of Z6 potato to 
the antecedent organism W8 potato, APHIS has determined that Z6 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 W8 potato to Z6 potato, whereby Z6 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 W8 potato to Z6 potato.
    APHIS will accept written comments on the request for extension, 
PPRSA, and our preliminary determination for Z6 potato for 30 days. 
These documents 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, APHIS will furnish a response to 
the petitioner regarding our final regulatory determination. APHIS will 
also publish a notice in the Federal Register announcing the regulatory 
status of Z6 potato.

National Environmental Policy Act

    Previous requests for extension of nonregulated status were often 
accompanied by environmental documentation prepared pursuant to 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).
    However, on May 24, 2018, APHIS issued a final rule (83 FR 24003-
24011, Docket No. APHIS-2013-0049) that revised our NEPA Implementing 
Procedures in 7 CFR part 372. Among other revisions, it added 
extensions of nonregulated status under 7 CFR part 340 to organisms 
similar to those already deregulated to the categories of APHIS actions 
that meet the criteria for categorical exclusion.

    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 22nd day of June 2020.
Mark Davidson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2020-13711 Filed 6-24-20; 8:45 am]
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