Pioneer Hi-Bred International; Determination of Nonregulated Status for Enhanced Grain Yield Potential and Glufosinate-Ammonium Resistant Maize, 83027-83028 [2020-28060]

Download as PDF 83027 Notices Federal Register Vol. 85, No. 245 Monday, December 21, 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. AGENCY FOR INTERNATIONAL DEVELOPMENT 60-Day Notice of Proposed Information Collection—Development Information Solution Bureau for Management, Office of Acquisition and Assistance, Policy Division, United States Agency for International Development (USAID). ACTION: Notice of request for public comment. AGENCY: The U.S. Agency for International Development (USAID) seeks Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, USAID requests public comment on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB. DATES: Comments must be received no later than February 19, 2021. ADDRESSES: You may submit comments by any of the following methods: 1. Web: Through the Federal eRulemaking Portal at https:// www.regulations.gov. Follow the instructions for submitting comments. 2. Email: policymailbox@usaid.gov. FOR FURTHER INFORMATION CONTACT: Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument, to Marcelle Wijesinghe at 202–916–2606 or via email at mwijesinghe@usaid.gov. SUPPLEMENTARY INFORMATION: SUMMARY: Instructions All comments must be in writing and submitted through the method(s) specified in the Addresses section above. All submissions must include the VerDate Sep<11>2014 22:33 Dec 18, 2020 Jkt 253001 information collection title. Please include your name, title, organization, postal address telephone number, and email address in the text of the message. Please note that comments submitted in response to this Notice are public record. We recommend that you do not submit detailed personal information, Confidential Business Information, or any information that is otherwise protected from disclosure by statute. USAID will only address comments that explain why the proposed collection would be inappropriate, ineffective, or unacceptable without a change. Comments that are insubstantial or outside the scope of the notice of request for public comment may not be considered. Purpose USAID is implementing the Development Information Solution (DIS) Pilot to consolidate reporting, improve efficiencies, and facilitate evidencebased decision-making. 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Contractors and recipients will use the access to DIS during the pilot to submit indicator data and narrative on the deviation between indicator results and targets, when required as a subset of performance reporting under special award requirements. We estimate that indicator information will be submitted to DIS quarterly. As the DIS pilot progresses, USAID will use information from the pilot to inform rulemaking under Regulation Identifier Number PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 (RIN) 0412–AA90, which will require contractors and grant recipients to submit digital information required under awards through the DIS, replacing other current methods of submission. This information collection request will be updated in conjunction with the rulemaking to capture digital information submission requirements for information collected under other standard award terms. Overview of Information Collection • Title of Information Collection: USAID Development Information Solution Pilot. • Type of Review: A New Information Collection. • Respondents: USAID contractors and grant and cooperative agreement recipients. • Estimated Number of Annual Responses—DIS Access: 2,368. • Estimated Number of Annual Burden Hours—DIS Access: 1,184. • Estimated Number of Annual Responses—Indicator Information: 11,236. • Estimated Number of Annual Burden Hours—Indicator Information: 2,809. • Total Estimated Number of Annual Responses: 13,604. • Total Estimated Number of Annual Burden Hours: 3,993. Dated: December 15, 2020. Mark Walther, Senior Procurement Executive. [FR Doc. 2020–27989 Filed 12–18–20; 8:45 am] BILLING CODE 6116–01–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2019–0040] Pioneer Hi-Bred International; Determination of Nonregulated Status for Enhanced Grain Yield Potential and Glufosinate-Ammonium Resistant Maize Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: We are advising the public of our determination that the corn variety designated as maize event DP202216, which has been genetically engineered SUMMARY: E:\FR\FM\21DEN1.SGM 21DEN1 83028 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices for increased yield potential and resistance to the herbicide glufosinateammonium, is no longer considered regulated under our regulations governing the introduction of certain genetically engineered organisms. Our determination is based on evaluation of information Pioneer submitted in its petition for a determination of nonregulated status, our analyses, and public comments received in response to previous notices announcing the availability of the petition for nonregulated status and our associated environmental assessment and plant pest risk assessment. This notice also announces the availability of our written determination and finding of no significant impact. DATES: This change in regulatory status will be recognized December 21, 2020. ADDRESSES: You may read the documents referenced in this notice and the comments we received at https:// www.regulations.gov/ #!docketDetail;D=APHIS-2019-0040, or in our reading 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) 799–7039 before coming. Supporting documents are also available on the APHIS website at https://www.aphis.usda.gov/aphis/ ourfocus/biotechnology/permitsnotifications-petitions/petitions/ petition-status. 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, regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products modified or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. 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 1 Although this final rule (termed the SECURE rule) published revisions to 7 CFR part 340 with phased effective dates beginning August 17, 2020 (https://www.aphis.usda.gov/brs/fedregister/BRS_ 2020518.pdf), the SECURE rule stated that the petition evaluation process found in the previous regulations would continue to be used for a period VerDate Sep<11>2014 22:33 Dec 18, 2020 Jkt 253001 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. APHIS received a petition (APHIS Petition Number 19–101–01p) from Pioneer Hi-Bred International, Inc. (Pioneer) on April 10, 2019, seeking a determination of nonregulated status for a maize event designated as DP202216, which has been genetically engineered for enhanced grain yield potential and glufosinate-ammonium resistance. The Pioneer petition stated that this maize is unlikely to pose a plant pest risk and, therefore, should not be regulated under APHIS’ regulations in 7 CFR part 340. According to our process 2 for soliciting public comment when considering petitions for determination of nonregulated status of GE organisms, APHIS accepts written comments regarding a petition once APHIS deems it complete. On July 25, 2019, APHIS published a notice 3 in the Federal Register (84 FR 35850–35851, Docket No. APHIS–2019–0040) announcing the availability of the Pioneer petition for public comment. Four comments were received. Two were opposed to deregulating DP202216 maize, one comment was in favor of deregulation, and one comment was unrelated to the petition. APHIS evaluated the issues raised during the initial comment period and, where appropriate, incorporated a discussion of them within a draft environmental assessment (EA). A second opportunity for public involvement was provided on July 20, 2020, with a notice 4 published in the Federal Register (85 FR 43807–43809, Docket No. APHIS–2019–0040) announcing the availability of the draft EA and preliminary plant pest risk assessment (PPRA) for public review and comment. That comment period closed August 19, 2020. APHIS received two comments. Both comments were in favor of the petition, and neither commenter provided new information or data (for example, peer-reviewed of time following that August 17, 2020 effective date. This product was evaluated in accordance with that process. 2 On March 6, 2012, APHIS published in the Federal Register (77 FR 13258–13260, Docket No. APHIS–2011–0129) a notice describing our public review process for soliciting public comments and information when considering petitions for determinations of nonregulated status for GE organisms. To view the notice, go to https:// www.regulations.gov/#!docketDetail;D=APHIS2011-0129. 3 To view the notice, the petition, supporting documents, and the comments we received, go to https://www.regulations.gov/ #!docketDetail;D=APHIS-2019-0040. 4 See footnote 3. PO 00000 Frm 00002 Fmt 4703 Sfmt 9990 publications or similar science-based literature) regarding the draft EA or preliminary PPRA. National Environmental Policy Act After reviewing and evaluating the comments received during the comment period on the draft EA, preliminary PPRA, and other information, APHIS has prepared a final EA, which provides the public with documentation of APHIS’ review and analysis of any potential environmental impacts associated with the determination of nonregulated status of DP202216 maize. The EA was prepared in accordance with: (1) The National Environmental Policy Act (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 our EA, the response to public comments and other pertinent scientific data, APHIS has reached a finding of no significant impact (FONSI) with regard to the preferred alternative identified in the EA (to make a determination of nonregulated status of DP202216 maize). Determination Based on APHIS’ analysis of field and laboratory data submitted by Pioneer, references provided in the petition, peer-reviewed publications, information analyzed in the EA, the PPRA, the public comments, and information provided in APHIS’ response to those public comments, APHIS has determined that DP202216 maize is unlikely to pose a plant pest risk and therefore is no longer subject to our regulations governing the introduction of certain GE organisms. Copies of the signed determination document, PPRA, final EA, and FONSI, as well as the previously published petition and supporting documents, are available as indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT section in this notice. 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 16th day of December 2020. Michael Watson, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2020–28060 Filed 12–18–20; 8:45 am] BILLING CODE 3410–34–P E:\FR\FM\21DEN1.SGM 21DEN1

Agencies

[Federal Register Volume 85, Number 245 (Monday, December 21, 2020)]
[Notices]
[Pages 83027-83028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28060]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2019-0040]


Pioneer Hi-Bred International; Determination of Nonregulated 
Status for Enhanced Grain Yield Potential and Glufosinate-Ammonium 
Resistant Maize

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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

SUMMARY: We are advising the public of our determination that the corn 
variety designated as maize event DP202216, which has been genetically 
engineered

[[Page 83028]]

for increased yield potential and resistance to the herbicide 
glufosinate-ammonium, is no longer considered regulated under our 
regulations governing the introduction of certain genetically 
engineered organisms. Our determination is based on evaluation of 
information Pioneer submitted in its petition for a determination of 
nonregulated status, our analyses, and public comments received in 
response to previous notices announcing the availability of the 
petition for nonregulated status and our associated environmental 
assessment and plant pest risk assessment. This notice also announces 
the availability of our written determination and finding of no 
significant impact.

DATES: This change in regulatory status will be recognized December 21, 
2020.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received at https://www.regulations.gov/#!docketDetail;D=APHIS-2019-0040, or in our reading 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) 799-7039 before coming.
    Supporting documents are also available on the APHIS website at 
https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status.

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, regulate, among other things, the 
introduction (importation, interstate movement, or release into the 
environment) of organisms and products modified or produced through 
genetic engineering that are plant pests or that there is reason to 
believe are plant pests.
    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.
---------------------------------------------------------------------------

    \1\ Although this final rule (termed the SECURE rule) published 
revisions to 7 CFR part 340 with phased effective dates beginning 
August 17, 2020 (https://www.aphis.usda.gov/brs/fedregister/BRS_2020518.pdf), the SECURE rule stated that the petition 
evaluation process found in the previous regulations would continue 
to be used for a period of time following that August 17, 2020 
effective date. This product was evaluated in accordance with that 
process.
---------------------------------------------------------------------------

    APHIS received a petition (APHIS Petition Number 19-101-01p) from 
Pioneer Hi-Bred International, Inc. (Pioneer) on April 10, 2019, 
seeking a determination of nonregulated status for a maize event 
designated as DP202216, which has been genetically engineered for 
enhanced grain yield potential and glufosinate-ammonium resistance. The 
Pioneer petition stated that this maize is unlikely to pose a plant 
pest risk and, therefore, should not be regulated under APHIS' 
regulations in 7 CFR part 340.
    According to our process \2\ for soliciting public comment when 
considering petitions for determination of nonregulated status of GE 
organisms, APHIS accepts written comments regarding a petition once 
APHIS deems it complete. On July 25, 2019, APHIS published a notice \3\ 
in the Federal Register (84 FR 35850-35851, Docket No. APHIS-2019-0040) 
announcing the availability of the Pioneer petition for public comment. 
Four comments were received. Two were opposed to deregulating DP202216 
maize, one comment was in favor of deregulation, and one comment was 
unrelated to the petition. APHIS evaluated the issues raised during the 
initial comment period and, where appropriate, incorporated a 
discussion of them within a draft environmental assessment (EA).
---------------------------------------------------------------------------

    \2\ On March 6, 2012, APHIS published in the Federal Register 
(77 FR 13258-13260, Docket No. APHIS-2011-0129) a notice describing 
our public review process for soliciting public comments and 
information when considering petitions for determinations of 
nonregulated status for GE organisms. To view the notice, go to 
https://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
    \3\ To view the notice, the petition, supporting documents, and 
the comments we received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2019-0040.
---------------------------------------------------------------------------

    A second opportunity for public involvement was provided on July 
20, 2020, with a notice \4\ published in the Federal Register (85 FR 
43807-43809, Docket No. APHIS-2019-0040) announcing the availability of 
the draft EA and preliminary plant pest risk assessment (PPRA) for 
public review and comment. That comment period closed August 19, 2020. 
APHIS received two comments. Both comments were in favor of the 
petition, and neither commenter provided new information or data (for 
example, peer-reviewed publications or similar science-based 
literature) regarding the draft EA or preliminary PPRA.
---------------------------------------------------------------------------

    \4\ See footnote 3.
---------------------------------------------------------------------------

National Environmental Policy Act

    After reviewing and evaluating the comments received during the 
comment period on the draft EA, preliminary PPRA, and other 
information, APHIS has prepared a final EA, which provides the public 
with documentation of APHIS' review and analysis of any potential 
environmental impacts associated with the determination of nonregulated 
status of DP202216 maize. The EA was prepared in accordance with: (1) 
The National Environmental Policy Act (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 our EA, 
the response to public comments and other pertinent scientific data, 
APHIS has reached a finding of no significant impact (FONSI) with 
regard to the preferred alternative identified in the EA (to make a 
determination of nonregulated status of DP202216 maize).

Determination

    Based on APHIS' analysis of field and laboratory data submitted by 
Pioneer, references provided in the petition, peer-reviewed 
publications, information analyzed in the EA, the PPRA, the public 
comments, and information provided in APHIS' response to those public 
comments, APHIS has determined that DP202216 maize is unlikely to pose 
a plant pest risk and therefore is no longer subject to our regulations 
governing the introduction of certain GE organisms.
    Copies of the signed determination document, PPRA, final EA, and 
FONSI, as well as the previously published petition and supporting 
documents, are available as indicated under ADDRESSES and FOR FURTHER 
INFORMATION CONTACT section in this notice.

    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 16th day of December 2020.
Michael Watson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2020-28060 Filed 12-18-20; 8:45 am]
BILLING CODE 3410-34-P

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