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 (Corn) Genetically Engineered for Insect Resistance and Herbicide Tolerance
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Abstract
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) DP23211 insect-resistant and glufosinate-ammonium-tolerant maize (corn) to DP51291 maize (corn). Similar to DP23211 corn, DP51291 corn was genetically engineered to express the IPD072Aa protein for control of certain susceptible corn rootworm pests, the phosphinothricin acetyltransferase protein as a selectable marker and for tolerance to glufosinate herbicide, and the phosphomannose isomerase protein as a selectable marker. We are making the extension request, our draft plant pest risk similarity assessment, and preliminary determination of nonregulated status available for public review and comment.
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<title>Federal Register, Volume 91 Issue 44 (Friday, March 6, 2026)</title>
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[Federal Register Volume 91, Number 44 (Friday, March 6, 2026)]
[Notices]
[Pages 11028-11029]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-04459]
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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
appearing in this section.
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Federal Register / Vol. 91, No. 44 / Friday, March 6, 2026 /
Notices
[[Page 11028]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2025-0411]
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 (Corn) Genetically
Engineered for Insect Resistance and Herbicide Tolerance
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice of availability.
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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) DP23211 insect-resistant and glufosinate-ammonium-tolerant
maize (corn) to DP51291 maize (corn). Similar to DP23211 corn, DP51291
corn was genetically engineered to express the IPD072Aa protein for
control of certain susceptible corn rootworm pests, the
phosphinothricin acetyltransferase protein as a selectable marker and
for tolerance to glufosinate herbicide, and the phosphomannose
isomerase protein as a selectable marker. We are making the extension
request, our draft plant pest risk similarity assessment, and
preliminary determination of nonregulated status available for public
review and comment.
DATES: We will consider all comments that we receive on or before April
6, 2026.
ADDRESSES: You may submit comments by either of the following methods:
<bullet> Federal eRulemaking Portal: Go to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Enter APHIS-2025-0411 in the Search field. Select the Documents tab,
then select the Comment button in the list of documents.
<bullet> Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2025-0411, Regulatory Analysis and Development, PPD,
APHIS, 5601 Sunnyside Ave., #AP760, Beltsville, MD 20705.
The extension request, draft plant pest risk similarity assessment,
preliminary determination of nonregulated status, and any comments we
receive on this docket may be viewed at <a href="http://www.regulations.gov">www.regulations.gov</a> or in our
reading room, located in 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.
FOR FURTHER INFORMATION CONTACT: Mr. Alan Pearson, Biotechnology
Regulatory Services, APHIS, USDA, 5601 Sunnyside Avenue, AP100,
Beltsville, MD 20705; (301) 851-3944; email: <a href="/cdn-cgi/l/email-protection#c0a1aca1aeeeb0a5a1b2b3afae80b5b3a4a1eea7afb6"><span class="__cf_email__" data-cfemail="e1808d808fcf91848093928e8fa194928580cf868e97">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the authority of the plant pest
provisions of the Plant Protection Act (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 organisms and products are
considered ``regulated articles.''
Section 340.6(e)(2) of the regulations provides that any person may
request that APHIS extend a determination of nonregulated status to
other organisms. Such a request shall include information to establish
the similarity of the antecedent organism and the regulated article in
question.
On December 1, 2023, APHIS announced \1\ its determination of
nonregulated status of Pioneer Hi-Bred International, Inc.'s (Pioneer)
DP23211 maize (corn), and the herbicide active ingredient glufosinate-
ammonium (hereafter referred to as DP23211 maize) and progeny derived
from it. DP23211 maize was developed using genetic engineering for
resistance to western corn rootworm. APHIS has received a request for
an extension of that determination of nonregulated status of DP23211
maize to insect resistant and herbicide tolerant maize DP-
[Oslash]51291-2 referred to as DP51291 (APHIS Petition Number 25-171-
01ext), also from Pioneer. In its request, Pioneer stated that this
maize is similar to the antecedent organism DP23211 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.
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\1\ To view the notice, go to <a href="http://www.regulations.gov">www.regulations.gov</a> and enter
APHIS-2020-0098 in the Search field.
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Similar to DP23211 maize, DP51291 maize was genetically engineered
to express the IPD072Aa protein for control of certain susceptible corn
rootworm pests. Also similar to DP23211 maize, DP51291 maize was
genetically engineered to express the phosphinothricin
acetyltransferase protein as a selectable marker and for tolerance to
glufosinate herbicide, and the phosphomannose isomerase protein as a
selectable marker. Further, DP51291 maize was developed using site-
specific integration similar to DP23211 maize.
APHIS has prepared a plant pest risk similarity assessment (PPRSA)
to compare DP51291 maize to the antecedent DP23211 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 DP51291 maize to the
antecedent DP23211 maize, APHIS has determined that DP51291 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 for DP51291 maize, whereby DP51291 maize would
no longer be subject to our regulations in 7 CFR part 340 governing
organisms developed using genetic engineering.
We are therefore publishing this notice to make available our
evaluation and inform the public of our preliminary decision to extend
the
[[Page 11029]]
determination of nonregulated status for DP51291 maize.
APHIS will accept written comments on the request for extension,
PPRSA, and our preliminary determination for DP51291 maize for 30 days.
These documents are available for public review as indicated under
ADDRESSES and from the individual listed under the 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
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 <a href="https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status">https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status</a>. 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 of DP51291 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 3rd day of March 2026.
Kelly Moore,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2026-04459 Filed 3-5-26; 8:45 am]
BILLING CODE 3410-34-P
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