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, 38110-38111 [2020-13711]

Download as PDF 38110 Federal Register / Vol. 85, No. 123 / Thursday, June 25, 2020 / Notices Agency, including whether the information will have practical utility; (2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses. Estimate of burden: The public burden for this collection of information is estimated to average 0.25 hours per response. Respondents: Importers, exporters, and shippers of bees and related articles; foreign and State governments; and containment facilities. Estimated annual number of respondents: 18. Estimated annual number of responses per respondent: 12. Estimated annual number of responses: 210. Estimated total annual burden on respondents: 50 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.) All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record. Done in Washington, DC, this 19th day of June 2020. Mark Davidson, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2020–13686 Filed 6–24–20; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service jbell on DSKJLSW7X2PROD with NOTICES [Docket No. APHIS–2020–0048] Animal and Plant Health Inspection Service, USDA. ACTION: Notice. VerDate Sep<11>2014 19:15 Jun 24, 2020 Jkt 250001 You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://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 https://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: cynthia.a.eck@ usda.gov. ADDRESSES: 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 SUPPLEMENTARY INFORMATION: 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: 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. SUMMARY: PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 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 § 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 § 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. 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. 1 https://www.regulations.gov/document? D=APHIS-2014-0076-0160. E:\FR\FM\25JNN1.SGM 25JNN1 jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 123 / Thursday, June 25, 2020 / Notices 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, peerreviewed 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 § 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 § 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. VerDate Sep<11>2014 19:52 Jun 24, 2020 Jkt 250001 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] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Rural Business-Cooperative Service [DOCLET #: RBS–20–CO–OP–2020] Inviting Applications for SociallyDisadvantaged Groups Grants Rural Business—Cooperative Service, USDA. ACTION: Notice of Funding Availability. AGENCY: This Notice announces that the Rural Business-Cooperative Service (Agency) is announcing fiscal year (FY) 2020 funding for applications for the Socially-Disadvantaged Groups Grant (SDGG) program. The program funding level for FY2020 is a total of $3.0 million. Detailed information can be found on the SDGG website located at https://www.rd.usda.gov/programsservices/socially-disadvantaged-groupsgrant. Expenses incurred in developing applications are the responsibility of the applicant. The purpose of this program is to provide technical assistance to SociallyDisadvantaged Groups in rural areas. Eligible applicants include SUMMARY: PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 38111 Cooperatives, Groups of Cooperatives, and Cooperative Development Centers. This program supports Rural Development’s (RD) mission of improving the quality of life for rural Americans and commitment to directing resources to those who most need them. DATES: Completed applications for grants must be submitted electronically by no later than midnight Eastern Time August 10, 2020, through https:// www.grants.gov to be eligible for grant funding. Please review the Grants.gov website at https://www.grants.gov/web/ grants/applicants/organizationregistration.html for instructions on the process of registering your organization as soon as possible to ensure that you are able to meet the electronic application deadline. Late applications are not eligible for funding under this Notice and will not be evaluated. ADDRESSES: You are encouraged to contact your USDA Rural Development State Office well in advance of the application deadline to discuss your project and ask any questions about the application process. Contact information for State Offices can be found at: https://www.rd.usda.gov/ contact-us/state-offices. Program guidance as well as application templates may be obtained at https://www.rd.usda.gov/programsservices/socially-disadvantaged-groupsgrant or by contacting your State Office. To submit an electronic application, follow the instructions for the SDGG funding announcement located at https:// www.grants.gov. Please review the Grants.gov website at https:// www.grants.gov/web/grants/applicants/ organization-registration.html for instructions on the process of registering your organization as soon as possible to ensure you can meet the electronic application deadline. You are strongly encouraged to file your application early and allow sufficient time to manage any technical issues that may arise. FOR FURTHER INFORMATION CONTACT: David Chestnut, Branch Chief, Program Management Division, Rural BusinessCooperative Service, United States Department of Agriculture, 1400 Independence Avenue SW, Mail Stop3226, Room 4204-South, Washington, DC 20250–3226, (202) 692–5233 or email David.chestnut@usda.gov. SUPPLEMENTARY INFORMATION: Preface The Agency encourages applications that will support recommendations made in the Rural Prosperity Task Force report to help improve life in rural America. https://www.usda.gov/topics/ rural/rural-prosperity. Applicants are E:\FR\FM\25JNN1.SGM 25JNN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://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 https://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.
---------------------------------------------------------------------------

    \1\ https://www.regulations.gov/document?D=APHIS-2014-0076-0160.
---------------------------------------------------------------------------

    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]
BILLING CODE 3410-34-P

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