[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.

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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 http://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.
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    \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.
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    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).
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    \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 
http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
    \3\ To view the notice, the petition, supporting documents, and 
the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2019-0040.
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    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.
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    \4\ See footnote 3.
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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]
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