[Federal Register Volume 88, Number 230 (Friday, December 1, 2023)]
[Notices]
[Pages 83896-83897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26458]


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 Notices
                                                 Federal Register
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 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 
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  Federal Register / Vol. 88, No. 230 / Friday, December 1, 2023 / 
Notices  

[[Page 83896]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2020-0098]


Pioneer Hi-Bred International, Inc.; Determination of 
Nonregulated Status for Insect Resistant and Herbicide-Tolerant 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 DP23211 
maize (corn), which has been developed using genetic engineering for 
insect resistance to western corn rootworm and contains the gene that 
codes for the phosphinothricin acetyltransferase protein responsible 
for tolerance to glufosinate-ammonium herbicides, and also the gene 
that encodes for the phosphomannose isomerase protein as a selectable 
marker, is no longer considered regulated. Our determination is based 
on our evaluation of information Pioneer Hi-Bred International, Inc. 
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 on December 
1, 2023.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received at regulations.gov, 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) 799-7039 before coming.
    Supporting documents are also available on the APHIS website at 
https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/regulatory-processes/petitions/petition-status/petitions-table.

FOR FURTHER INFORMATION CONTACT: Dr. Alan Pearson, Biotechnology 
Regulatory Services, APHIS, USDA, 4700 River Road, Unit 147, Riverdale, 
MD 20737-1236; (301) 851-3944; 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 importation, interstate movement, or release into the environment 
of organisms modified or produced through genetic engineering that are 
plant pests or pose a plausible plant pest risk.
    The petition for nonregulated status described in this notice was 
evaluated under the version of the regulations effective at the time 
that it was received. The Animal and Plant Health Inspection Service 
(APHIS) issued a final rule, published in the Federal Register on May 
18, 2020 (85 FR 29790-29838, Docket No. APHIS-2018-0034),\1\ revising 7 
CFR part 340; however, the final rule was implemented in phases. The 
new Regulatory Status Review (RSR) process, which replaces the petition 
for determination of nonregulated status process, became effective on 
April 5, 2021, for corn, soybean, cotton, potato, tomato, and alfalfa. 
The RSR process became effective for all crops as of October 1, 2021. 
However, ``[u]ntil RSR is available for a particular crop . . . APHIS 
will continue to receive petitions for determination of nonregulated 
status for the crop in accordance with the [legacy] regulations at 7 
CFR 340.6.'' (85 FR 29815). This petition for a determination of 
nonregulated status was evaluated in accordance with the regulations at 
7 CFR 340.6 (2020) as it was received by APHIS on July 21, 2020.
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    \1\ To view the final rule, go to www.regulations.gov and enter 
APHIS-2018-0034 in the Search field.
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    Pioneer Hi-Bred International (Pioneer) submitted a petition (APHIS 
Petition Number 20-203-01p) to APHIS, seeking a determination of 
nonregulated status for DP23211 maize (corn), which was developed using 
genetic engineering for insect resistance to western corn rootworm and 
contains the gene that codes for the phosphinothricin acetyltransferase 
protein responsible for tolerance to glufosinate-ammonium herbicides. 
DP23211 corn also contains the gene that encodes for the phosphomannose 
isomerase protein, which is used as a selectable marker. The petition 
stated that DP23211 corn 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 for 
organisms developed using genetic engineering, APHIS accepts written 
comments regarding a petition once APHIS deems it complete. On November 
3, 2020, APHIS published a notice in the Federal Register (85 FR 69564-
69566, Docket No. APHIS-2020-0098) announcing the availability of the 
Pioneer petition for public comment. Four comments were received. One 
comment was from an individual, which stated opposition to 
biotechnology-derived crops in general. Three comments were received 
from industry organizations, which generally supported approval of 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 organisms developed using genetic 
engineering. To view the notice, go to www.regulations.gov and enter 
APHIS-2011-0129 in the Search field.
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    A second opportunity for public involvement was provided on April 
11, 2023, with a notice published in the Federal Register (88 FR 21602-
21603, Docket No. APHIS-2020-0098) announcing the availability of the 
draft EA and draft plant pest risk assessment (PPRA) for public review 
and comment. That comment period closed on May 11,

[[Page 83897]]

2023. APHIS received three comments. One commenter expressed concern 
that the DvSSJ1 dsRNA insect resistant trait in DP23211 corn is 
associated with an animal and thus presents cultural/dietary concerns 
for plant-based diet adherents who may inadvertently consume DP23211 
corn, and thereby DvSSJ1 dsRNA. We responded that the potential risk of 
exposure to insect DNA/RNA via inadvertent consumption of DP23211 corn 
products is not expected to appreciably increase in the event of 
deregulation and subsequent production of DP23211 corn, and that DvSSJ1 
dsRNA poses no health risk to humans. Another commenter expressed 
opposition to biotechnology-derived crops, in general. A comment from a 
State organization representing farmers expressed support for the 
deregulation of DP23211 corn. APHIS provided a response to the comments 
in Appendix 2 of our final EA. None of the comments identified new 
information or data regarding the draft EA or draft PPRA.

National Environmental Policy Act

    After reviewing and evaluating the comments received during the 
comment period on the draft EA, draft 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 DP23211 corn. 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, 
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 for DP23211 corn).

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 DP23211 corn is unlikely to pose a 
plant pest risk and therefore is no longer subject to our regulations 
governing the movement of organisms developed using genetic 
engineering.
    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 from the 
person listed under the 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 27th day of November 2023.
Michael Watson,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2023-26458 Filed 11-30-23; 8:45 am]
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