Notice2025-18823
Bayer U.S.-Crop Science: Determination of Nonregulated Status of MON 95379 Lepidopteran-Protected Maize (Corn) Genetically Engineered To Produce Two Insecticidal Proteins To Protect Against Feeding Damage Caused by Target Lepidopteran Pests
Primary source
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Published
September 29, 2025
Issuing agencies
Agriculture DepartmentAnimal and Plant Health Inspection Service
Abstract
We are advising the public of our determination that MON 95379 Lepidopteran-Protected Maize (corn), which was developed using genetic engineering to produce two insecticidal proteins to protect against feeding damage caused by target lepidopteran pests, is no longer considered regulated. Our determination is based on our evaluation of information and data Bayer U.S.-Crop Science submitted in its petition for a determination of nonregulated status, available scientific data, the plant pest risk assessment, and public comments received in response to a previous notice announcing the availability of the petition for nonregulated status and a draft plant pest risk assessment. This notice announces the availability of our written determination and the availability of the final plant pest risk assessment.
Full Text
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<title>Federal Register, Volume 90 Issue 186 (Monday, September 29, 2025)</title>
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[Federal Register Volume 90, Number 186 (Monday, September 29, 2025)]
[Notices]
[Pages 46546-46547]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18823]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2020-0113]
Bayer U.S.-Crop Science: Determination of Nonregulated Status of
MON 95379 Lepidopteran-Protected Maize (Corn) Genetically Engineered To
Produce Two Insecticidal Proteins To Protect Against Feeding Damage
Caused by Target Lepidopteran Pests
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public of our determination that MON 95379
Lepidopteran-Protected Maize (corn), which was developed using genetic
engineering to produce two insecticidal proteins to protect against
feeding damage caused by target lepidopteran pests, is no longer
considered regulated. Our determination is based on our evaluation of
information and data Bayer U.S.-Crop Science submitted in its petition
for a determination of nonregulated status, available scientific data,
the plant pest risk assessment, and public comments received in
response to a previous notice announcing the availability of the
petition for nonregulated status and a draft plant pest risk
assessment. This notice announces the availability of our written
determination and the
[[Page 46547]]
availability of the final plant pest risk assessment.
DATES: This change in regulatory status is recognized as of September
24, 2025.
ADDRESSES: You may read the petition, our determination referenced in
this notice, and supporting documents by any of the following methods:
<bullet> Federal eRulemaking Portal: Go to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Enter APHIS-2020-0113 in the Search field.
<bullet> 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. Joseph Tangredi, Biotechnology
Regulatory Services, APHIS, USDA, 5601 Sunnyside Avenue, AP100-3-WS-
1100, Beltsville, MD 20705; (301) 851-4061; email:
<a href="/cdn-cgi/l/email-protection#e983869a8c9981c79d88878e9b8c8d80a99c9a8d88c78e869f"><span class="__cf_email__" data-cfemail="53393c2036233b7d27323d342136373a13262037327d343c25">[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.) and 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,'' APHIS regulates,
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.''
The regulations in Sec. 340.6(a) provide 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.
APHIS received a petition (APHIS Petition Number 20-205-01p) from
Bayer U.S.-Crop Science seeking a determination of nonregulated status
for MON 95379 Lepidopteran-Protected Maize (corn) which has been
developed using genetic engineering to produce two insecticidal
proteins to protect against feeding damage caused by target
lepidopteran pests. The petition provides information in support of the
position that MON 95379 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 published
the draft PPRA in the Federal Register [90 FR 23513-23514, APHIS-2020-
0113] and accepted public comments from June 3, 2025, through July 3,
2025. APHIS received five hundred ninety-four comments.
APHIS also prepared and published a draft environmental assessment
(EA). However, on July 9, 2025, APHIS issued a Program Update titled
``APHIS Announces Update to Practices for Reviewing Petitions Seeking a
Determination of Nonregulated Status for Organisms Altered or Produced
Through Genetic Engineering,'' available at <a href="https://www.aphis.usda.gov/news/program-update/aphis-announces-update-practices-reviewing-petitions-seeking-determination">https://www.aphis.usda.gov/news/program-update/aphis-announces-update-practices-reviewing-petitions-seeking-determination</a>. In this Program Update, APHIS
announced that it will no longer prepare a National Environmental
Policy Act analysis to accompany its review of petitions seeking a
determination nonregulated status. Therefore, consistent with this July
9, 2025 Program Update, APHIS terminated work on the EA.
Determination
Based on APHIS' evaluation in the final PPRA of information and
data submitted by Bayer U.S.-Crop Science in its petition, available
scientific data, and public comments received in response to the
petition and PPRA, APHIS has determined that MON 95379 is unlikely to
pose a greater plant pest risk than the unmodified comparator and
therefore is no longer subject to our regulation governing the
introduction of certain organisms developed using genetic engineering.
Copies of the signed determination, final PPRA, and response to
comments, as well as the previously published petition and supporting
documents, are available as indicated in the ADDRESSES and FOR FURTHER
INFORMATION CONTACT sections of 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 24th day of September 2025.
Michael Watson,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2025-18823 Filed 9-26-25; 8:45 am]
BILLING CODE 3410-34-P
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