Nonregulated Status Determination for MON 95275 Maize

Regs.gov: Animal and Plant Health Inspection Service

Published March 19th, 2026

Detected March 27th, 2026

Summary

The Animal and Plant Health Inspection Service (APHIS) has determined that MON 95275 maize, developed using genetic engineering for insect resistance, is no longer a regulated article. This determination, effective March 19, 2026, follows a review of submitted data, risk assessments, and public comments.

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What changed

APHIS has issued a notice announcing its determination that MON 95275 maize, a genetically engineered corn developed by Bayer CropScience to resist corn rootworm pests, is no longer subject to regulation under the Plant Protection Act and its associated regulations (7 CFR part 340). This decision is based on the agency's evaluation of Bayer's petition, scientific data, a plant pest risk assessment, and public comments received on a prior notice. The change in regulatory status is effective March 19, 2026.

Companies involved in the development or commercialization of genetically engineered organisms should note this determination signifies that MON 95275 maize will not be considered a "regulated article" moving forward. While this specific product is now outside the scope of 7 CFR part 340, entities seeking similar determinations for other genetically engineered organisms must still submit petitions and undergo APHIS's review process. Compliance officers should be aware that this marks a shift in the regulatory landscape for this specific maize variety, potentially impacting its future use and market access without the prior regulatory oversight.

What to do next

Review the written determination and supporting documents for MON 95275 maize.
Note the effective date of March 19, 2026, for the change in regulatory status.

Source document (simplified)

Content

ACTION:

Notice.

SUMMARY:

We are advising the public of our determination that MON 95275 maize (corn), which was developed using genetic engineering
to produce two insecticidal proteins and a double-stranded RNA transcript to provide protection from feeding damage caused
by targeted coleopteran (corn rootworm) insect pests, is no longer considered regulated. Our determination is based on our
evaluation of information and data Bayer CropScience 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 supporting documents.

DATES:

This change in regulatory status is recognized as of March 19, 2026.

ADDRESSES:

You may read the petition, our determination referenced in this notice, and supporting documents by any of the following methods:

• Federal eRulemaking Portal: Go to www.regulations.gov. Enter APHIS-2025-0021 in the Search field.

• Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2025-0021, Regulatory Analysis and Development, PPD, APHIS, 5601 Sunnyside Ave. #AP760,
Beltsville, MD 20705.

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, AP100-3-WS-1151, Beltsville, MD 20705;
(301) 851-3944; email: alan.pearson@usda.gov.

SUPPLEMENTARY INFORMATION:

Under the authority of the plant pest provisions of the Plant Protection Act (7 U.S.C. 7701-7772, 7781-7786) 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.”

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.

APHIS received a petition (APHIS Petition Number 25-083-01p) from Bayer CropScience (Bayer) seeking a determination of nonregulated
status for MON 95275 maize (corn), which has been developed using genetic engineering to produce two insecticidal proteins
and a double-stranded RNA transcript to provide protection from feeding damage caused by targeted coleopteran (corn rootworm)
insect pests. The petition provides information in support of petitioners' position that MON 95275 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 petition and draft PPRA in the
Federal Register
[90 FR 30035, APHIS-2025-0021] and accepted public comments from July 8, 2025, through September 8, 2025. APHIS received 11
comments by the close of the comment period. No comments addressed the PPRA. Five comments from individuals stated general
opposition to genetic engineering. These comments are non-substantive and will not be addressed further. One comment specifically
opposed deregulating the product and also expressed concerns related to deregulation contributing to carbon dioxide (CO 2) emissions. This comment is addressed in our response to comments. One comment remained neutral regarding the petition, but
also expressed concerns related to deregulation contributing to CO 2 emissions. This comment is also addressed in our response to comments. The remaining four comments from non-government organizations
expressed support in the deregulation of the corn. We note the support expressed by these commenters to deregulate the corn
for the record.

Determination

Based on APHIS' evaluation in the PPRA of information and data submitted by Bayer in its petition, available scientific data,
and public comments received in response to the petition and draft PPRA, APHIS has determined that MON 95275 is unlikely to
pose a greater plant pest risk than the unmodified comparator and therefore is no longer subject to the regulations in 7 CFR
part 340 governing the introduction of certain organisms developed using genetic engineering.

Copies of the signed determination, 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 25th day of March 2026. Kelly Moore, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2026-05978 Filed 3-26-26; 8:45 am] BILLING CODE 3410-34-P