Pioneer Hi-Bred International, Inc.; Availability of a Request and Plant Pest Risk Similarity Assessment for an Extension of Determination of Nonregulated Status for Maize for Use in the Seed Production Technology for Africa Process, 71875-71876 [2020-25037]

Download as PDF 71875 Notices Federal Register Vol. 85, No. 219 Thursday, November 12, 2020 This section of the FEDERAL REGISTER contains documents other than rules or proposed rules that are applicable to the public. Notices of hearings and investigations, committee meetings, agency decisions and rulings, delegations of authority, filing of petitions and applications and agency statements of organization and functions are examples of documents appearing in this section. DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2020–0097] Pioneer Hi-Bred International, Inc.; Availability of a Request and Plant Pest Risk Similarity Assessment for an Extension of Determination of Nonregulated Status for Maize for Use in the Seed Production Technology for Africa Process Animal and Plant Health Inspection Service, USDA. ACTION: Notice. 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 Pioneer Hi-Bred International, Inc.’s (Pioneer’s) DP– 32138–1 SPT maintainer maize to maize MS44 maintainer line DP56113 for use in the Seed Production Technology for Africa (SPTA) process (hereafter DP56113 SPTA maintainer maize). DP56113 SPTA maintainer maize has been genetically engineered for maintenance and recovery of malesterile maize breeding lines using the same construct and method of transformation as DP–32138–1 SPT maintainer maize. 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 December 14, 2020. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to http://www.regulations.gov/ #!docketDetail;D=APHIS-2020-0097. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2020–0097, Regulatory Analysis jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:07 Nov 10, 2020 Jkt 253001 and Development, PPD, APHIS, Station 3A–03.8, 4700 River Road, Unit 118, Riverdale, MD 20737–1238. The Pioneer 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-2020-0097 or in our reading room, which is located in Room 1620 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) 7997039 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. 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, ‘‘Movement of Organisms Modified or Produced Through Genetic Engineering,’’ 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 organisms and products are considered regulated articles. Pursuant to the terms set forth in a final rule published in the Federal Register on May 18, 2020 (85 FR 29790– 29838, Docket No. APHIS–2018–0034),1 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, or that APHIS extend a determination of nonregulated status to other organisms. Such an extension request must include information to establish the similarity of the antecedent organism and the regulated article in question. On June 28, 2011,2 APHIS announced its determination of nonregulated status 1 To view the final rule, go to http:// www.regulations.gov/#!docketDetail;D=APHIS2018-0034. 2 https://www.regulations.gov/ document?D=APHIS-2010-0041-0057. PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 of Pioneer Hi-Bred International, Inc.’s (Pioneer’s) DP–32138–1 SPT maintainer maize, which was genetically engineered for maintenance and recovery of male-sterile maize breeding lines. APHIS has received a request for an extension of that determination of nonregulated status of DP–32138–1 SPT maintainer maize to maintainer maize designated as MS44 maintainer line maize event DP-;56113–9 and referred to as DP56113 SPTA maintainer maize (APHIS Petition Number 20–043– 01.ext), also from Pioneer. DP56113 SPTA maintainer maize has also been genetically engineered for maintenance and recovery of male-sterile maize breeding lines. In its request, Pioneer stated that this maintainer maize is similar to the antecedent organism DP– 32138–1 SPT maintainer maize 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, DP56113 SPTA maintainer maize was developed using the same constructs and method of transformation as DP– 32138–1 SPT maintainer maize. Based on the information in the request, we have concluded that DP56113 SPTA maintainer maize is similar to DP– 32138–1 SPT maintainer maize. DP56113 SPTA maintainer maize is currently regulated under 7 CFR part 340. As part of our decision-making 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. APHIS has prepared a plant pest risk similarity assessment (PPRSA) to compare DP56113 SPTA maintainer maize to the antecedent. As described in the PPRSA, the same genetic constructs used in DP56113 SPTA maintainer maize were previously used in DP– 32138–1 SPT maintainer maize, and APHIS has concluded that DP56113 SPTA maintainer maize is unlikely to E:\FR\FM\12NON1.SGM 12NON1 jbell on DSKJLSW7X2PROD with NOTICES 71876 Federal Register / Vol. 85, No. 219 / Thursday, November 12, 2020 / Notices pose a plant health risk. Therefore, based on the similarity between DP56113 SPTA maintainer maize and DP–32138–1 SPT maintainer maize as described in the PPRSA, APHIS has concluded that DP56113 SPTA maintainer maize is no more likely to pose a plant pest risk than DP–32138– 1 SPT maintainer maize. APHIS has analyzed information submitted by Pioneer, 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 DP56113 SPTA maintainer maize to the antecedent organism DP– 32138–1 SPT maintainer maize, APHIS has determined that DP56113 SPTA maintainer maize 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 DP–32138–1 SPT maintainer maize to DP56113 SPTA maintainer maize, whereby DP56113 SPTA maintainer maize would no longer be subject to our regulations governing the introduction of certain genetically engineered organisms. We are therefore publishing this notice to make available our evaluation and inform the public of our preliminary decision to extend the determination of nonregulated status of DP–32138–1 SPT maintainer maize to DP56113 SPTA maintainer maize. APHIS will accept written comments on the request for extension, PPRSA, and our preliminary determination for DP56113 SPTA maintainer maize 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, if APHIS determines that no substantive information has been received that would warrant APHIS altering its preliminary regulatory determination, our preliminary regulatory determination will become final and effective upon notification of the public through an announcement on our website at https:// www.aphis.usda.gov/aphis/ourfocus/ biotechnology/permits-notificationspetitions/petitions/petition-status. APHIS will also furnish a response to VerDate Sep<11>2014 17:07 Nov 10, 2020 Jkt 253001 the petitioner regarding our final regulatory determination. No further Federal Register notice will be published announcing the final regulatory determination regarding DP56113 SPTA maintainer maize. 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 6th day of November 2020. Michael Watson, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2020–25037 Filed 11–10–20; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Forest Service Information Collection: Collaborative Forest Landscape Restoration Program Forest Service, USDA. Notice; request for comment. AGENCY: ACTION: In accordance with the Paperwork Reduction Act of 1995, the U.S. Forest Service (USFS) is seeking comments from all interested individuals and organizations on the renewal and revision of the information collection, Collaborative Forest Landscape Restoration Program. DATES: Comments must be received in writing on or before January 11, 2021 to be assured of consideration. Comments received after that date will be considered to the extent practicable. ADDRESSES: Comments concerning this notice should be addressed to Lindsay Buchanan, Collaborative Forest Landscape Restoration Program Coordinator, 1220 SW 3rd Ave., Portland, Oregon 97204. Comments may also be submitted by email to: lindsay.buchanan@usda.gov. The public may inspect comments received at 1220 SW 3rd Ave., Portland, Oregon 97204, during normal business hours. Visitors are encouraged to call ahead to 503– 808–2810 to facilitate entry to the building. FOR FURTHER INFORMATION CONTACT: Lindsay Buchanan, Collaborative Forest Landscape Restoration Program Coordinator, Forest Management, Range Management, and Vegetation Ecology, can be reached by phone at 503–808– 2810, or by email at lindsay.buchanan@ usda.gov. Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1–800–877– 8339, twenty-four hours a day, every day of the year, including holidays. SUMMARY: PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 SUPPLEMENTARY INFORMATION: Title: Collaborative Forest Landscape Restoration Program. OMB Number: 0596–0245. Expiration Date of Approval: January 31, 2021. Type of Request: Renewal with Revisions. Abstract: The Collaborative Forest Landscape Restoration Program (CFLRP) is a USFS program started in 2010 to encourage collaborative groups of neighboring landowners, to work with the Forest Service to find common ground pertaining to forest restoration. Such collaborative neighboring landowners include State, local, and Tribal government representatives, businesses, interest groups, and nonprofit organizations. Partners work with the USFS to implement restoration work and multi-party monitoring of landscape restoration treatments. The Forest Landscape Restoration Act (FLRA) of 2009 (16 U.S.C. 7303), which enabled the CFLRP, requires monitoring ‘‘to assess the positive or negative ecological, social, and economic effects of projects implementing a selected proposal for not less than 15 years after project implementation commences.’’ This Information Collection Request (ICR) will help meet the obligation for monitoring the social impacts on residents and stakeholders of activities conducted under the CFLRP. The scope of the ICR includes residents of communities within and adjacent to the CFLRP landscapes and collaborative participants. Gaining information from individuals who work or live in the geographic area of the CFLRP projects provides valuable information to partners and land management decision makers. To ensure the USFS is informed about the opinions of participants of collaborative processes and public members living in or around the CFLRP project, the USFS seeks to obtain approval by the Office of Management and Budget (OMB) of an ICR to collect both qualitative and quantitative feedback from stakeholders on management decisions, forest restoration work, monitoring activities, and land management planning. The information will be collected through a census survey of participants and a mail-in, on-line, and hard copy survey of residents. Through the collection of this information, managers and planners will obtain valuable information to inform future decisions. USFS public affairs staff, social scientists, and economists may also use this information, and USFS, academic, and other researchers may use or cite the results or data collected in publications. E:\FR\FM\12NON1.SGM 12NON1

Agencies

[Federal Register Volume 85, Number 219 (Thursday, November 12, 2020)]
[Notices]
[Pages 71875-71876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25037]


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Notices
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
and investigations, committee meetings, agency decisions and rulings, 
delegations of authority, filing of petitions and applications and agency 
statements of organization and functions are examples of documents 
appearing in this section.

========================================================================


Federal Register / Vol. 85, No. 219 / Thursday, November 12, 2020 / 
Notices

[[Page 71875]]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2020-0097]


Pioneer Hi-Bred International, Inc.; Availability of a Request 
and Plant Pest Risk Similarity Assessment for an Extension of 
Determination of Nonregulated Status for Maize for Use in the Seed 
Production Technology for Africa Process

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 Pioneer Hi-Bred International, Inc.'s 
(Pioneer's) DP-32138-1 SPT maintainer maize to maize MS44 maintainer 
line DP56113 for use in the Seed Production Technology for Africa 
(SPTA) process (hereafter DP56113 SPTA maintainer maize). DP56113 SPTA 
maintainer maize has been genetically engineered for maintenance and 
recovery of male-sterile maize breeding lines using the same construct 
and method of transformation as DP-32138-1 SPT maintainer maize. 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 
December 14, 2020.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2020-0097.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2020-0097, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
    The Pioneer 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-2020-0097 or in our reading 
room, which is located in Room 1620 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) 7997039 
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, ``Movement of Organisms Modified or 
Produced Through Genetic Engineering,'' 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 organisms and products are considered 
regulated articles.
    Pursuant to the terms set forth in a final rule published in the 
Federal Register on May 18, 2020 (85 FR 29790-29838, Docket No. APHIS-
2018-0034),\1\ 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, or that APHIS 
extend a determination of nonregulated status to other organisms. Such 
an extension request must include information to establish the 
similarity of the antecedent organism and the regulated article in 
question.
---------------------------------------------------------------------------

    \1\ To view the final rule, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0034.
---------------------------------------------------------------------------

    On June 28, 2011,\2\ APHIS announced its determination of 
nonregulated status of Pioneer Hi-Bred International, Inc.'s 
(Pioneer's) DP-32138-1 SPT maintainer maize, which was genetically 
engineered for maintenance and recovery of male-sterile maize breeding 
lines. APHIS has received a request for an extension of that 
determination of nonregulated status of DP-32138-1 SPT maintainer maize 
to maintainer maize designated as MS44 maintainer line maize event DP-
[Oslash]56113-9 and referred to as DP56113 SPTA maintainer maize (APHIS 
Petition Number 20-043-01.ext), also from Pioneer. DP56113 SPTA 
maintainer maize has also been genetically engineered for maintenance 
and recovery of male-sterile maize breeding lines. In its request, 
Pioneer stated that this maintainer maize is similar to the antecedent 
organism DP-32138-1 SPT maintainer maize 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.
---------------------------------------------------------------------------

    \2\ https://www.regulations.gov/document?D=APHIS-2010-0041-0057.
---------------------------------------------------------------------------

    As described in the extension request, DP56113 SPTA maintainer 
maize was developed using the same constructs and method of 
transformation as DP-32138-1 SPT maintainer maize. Based on the 
information in the request, we have concluded that DP56113 SPTA 
maintainer maize is similar to DP-32138-1 SPT maintainer maize. DP56113 
SPTA maintainer maize is currently regulated under 7 CFR part 340.
    As part of our decision-making 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.
    APHIS has prepared a plant pest risk similarity assessment (PPRSA) 
to compare DP56113 SPTA maintainer maize to the antecedent. As 
described in the PPRSA, the same genetic constructs used in DP56113 
SPTA maintainer maize were previously used in DP-32138-1 SPT maintainer 
maize, and APHIS has concluded that DP56113 SPTA maintainer maize is 
unlikely to

[[Page 71876]]

pose a plant health risk. Therefore, based on the similarity between 
DP56113 SPTA maintainer maize and DP-32138-1 SPT maintainer maize as 
described in the PPRSA, APHIS has concluded that DP56113 SPTA 
maintainer maize is no more likely to pose a plant pest risk than DP-
32138-1 SPT maintainer maize.
    APHIS has analyzed information submitted by Pioneer, 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 DP56113 SPTA 
maintainer maize to the antecedent organism DP-32138-1 SPT maintainer 
maize, APHIS has determined that DP56113 SPTA maintainer maize 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 DP-32138-1 SPT maintainer maize to DP56113 
SPTA maintainer maize, whereby DP56113 SPTA maintainer maize would no 
longer be subject to our regulations governing the introduction of 
certain genetically engineered organisms.
    We are therefore publishing this notice to make available our 
evaluation and inform the public of our preliminary decision to extend 
the determination of nonregulated status of DP-32138-1 SPT maintainer 
maize to DP56113 SPTA maintainer maize.
    APHIS will accept written comments on the request for extension, 
PPRSA, and our preliminary determination for DP56113 SPTA maintainer 
maize 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, if APHIS determines that no 
substantive information has been received that would warrant APHIS 
altering its preliminary regulatory determination, our preliminary 
regulatory determination will become final and effective upon 
notification of the public through an announcement on our website at 
https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status. 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 DP56113 SPTA 
maintainer maize.

    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 6th day of November 2020.
Michael Watson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2020-25037 Filed 11-10-20; 8:45 am]
BILLING CODE 3410-34-P