Bayer U.S.-Crop Science: Availability of a Petition for a Determination of Nonregulated Status and Draft Plant Pest Risk Assessment for MON 94637 Lepidopteran-Protected Soybean (Glycine Max)
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Abstract
We are advising the public that the Animal and Plant Health Inspection Service has received a petition from Bayer U.S.-Crop Science seeking a determination of nonregulated status for MON 94637 Lepidopteran-protected Soybean (Glycine max) which has been developed using genetic engineering to express two insecticidal proteins to protect against feeding damage caused by target lepidopteran pests. We are making the petition and draft plant pest risk assessment available for public review and comment.
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<title>Federal Register, Volume 91 Issue 32 (Wednesday, February 18, 2026)</title>
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[Federal Register Volume 91, Number 32 (Wednesday, February 18, 2026)]
[Notices]
[Page 7421]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03154]
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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.
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Federal Register / Vol. 91, No. 32 / Wednesday, February 18, 2026 /
Notices
[[Page 7421]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2026-0166]
Bayer U.S.-Crop Science: Availability of a Petition for a
Determination of Nonregulated Status and Draft Plant Pest Risk
Assessment for MON 94637 Lepidopteran-Protected Soybean (Glycine Max)
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 petition from Bayer U.S.-Crop Science
seeking a determination of nonregulated status for MON 94637
Lepidopteran-protected Soybean (Glycine max) which has been developed
using genetic engineering to express two insecticidal proteins to
protect against feeding damage caused by target lepidopteran pests. We
are making the petition and draft plant pest risk assessment available
for public review and comment.
DATES: We will consider all comments that we receive on or before April
20, 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-2026-0166 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-2026-0166, Regulatory Analysis and Development, PPD,
APHIS, 5601 Sunnyside Avenue #AP760, Beltsville, MD 20705.
The petition, draft plant pest risk assessment, 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, which is 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, AP100-3-WS-
1151, Beltsville, MD 20705; (301) 851-3944; email:
<a href="/cdn-cgi/l/email-protection#2b4a474a45055b4e4a595844456b5e584f4a054c445d"><span class="__cf_email__" data-cfemail="98f9f4f9f6b6e8fdf9eaebf7f6d8edebfcf9b6fff7ee">[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(a) of the regulations provides that 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. Paragraphs (b) and (c) of Sec. 340.6 describe
the form that a petition for a determination of nonregulated status
must take and the information that must be included in the petition.
APHIS has received a petition (APHIS Petition Number 25-321-01p)
from Bayer U.S.-Crop Science seeking a determination of nonregulated
status for MON 94637 Lepidopteran-protected Soybean (Glycine max),
referred to as MON 94637, which has been developed using genetic
engineering to express two insecticidal proteins to protect against
feeding damage caused by target lepidopteran pests. The petition states
that the information provided indicates that MON 94637 is unlikely to
pose a plant pest risk and therefore should not be regulated under
APHIS' regulations in 7 CFR part 340.
As part of our decision-making process regarding the organism's
regulatory status, APHIS prepared a draft plant pest risk assessment
(PPRA) to assess the plant pest risk of the organism. APHIS' draft PPRA
compared the pest risk posed by MON 94637 with that of the nonmodified
variety from which it was derived. The draft PPRA concluded that MON
94637 is unlikely to pose an increased plant pest risk compared to the
nonmodified soybean.
Paragraph (d) of Sec. 340.6 provides that APHIS will publish a
notice in the Federal Register providing 60 days for public comment on
petitions for a determination of nonregulated status. In accordance
with Sec. 340.6(d), we are publishing this notice to inform the public
that APHIS will accept written comments regarding the petition and
draft PPRA from interested or affected persons for a period of 60 days
from the date of this notice. The petition and draft PPRA are available
for public review and comment, and copies are available as indicated
under ADDRESSES and from the individual listed under the FOR FURTHER
INFORMATION CONTACT section of this notice. We are particularly
interested in receiving comments regarding biological or ecological
issues, and we encourage the submission of scientific data, studies, or
research to support your comments.
After the comment period closes, APHIS will review and evaluate any
information received during the comment period and any other relevant
information. Based upon available information, APHIS will respond to
the petitioner either approving or denying the petition. APHIS will
post its regulatory determination on its website and publish a notice
of availability in the Federal Register.
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 11th day of February 2026.
Kelly Moore,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2026-03154 Filed 2-17-26; 8:45 am]
BILLING CODE 3410-34-P
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