Bayer CropScience: Determination of Nonregulated Status of MON 95275 Maize

FR: 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, genetically engineered for insecticidal properties, is no longer a regulated article. This determination follows a review of submitted data and public comments, recognizing the change in regulatory status as of March 19, 2026.

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What changed

APHIS has issued a notice announcing its determination that MON 95275 maize, developed by Bayer CropScience using genetic engineering to produce insecticidal proteins and double-stranded RNA for pest protection, is no longer considered a regulated article under the Plant Protection Act. This decision is based on a petition submitted by Bayer CropScience, a plant pest risk assessment, and consideration of public comments.

This change in regulatory status means that MON 95275 maize is no longer subject to the specific regulatory requirements outlined in 7 CFR part 340 for genetically engineered organisms considered plant pests. While this is a final determination, entities involved in the cultivation, movement, or use of this maize should be aware of the new regulatory classification. The supporting documents and the written determination are available for review.

What to do next

Review the APHIS determination and supporting documents regarding MON 95275 maize.
Update internal compliance records to reflect the non-regulated status of MON 95275 maize.

Source document (simplified)

Notice

You may be interested in this older document that published on 07/08/2025 with action 'Notice of availability.' View Document

Bayer CropScience: Determination of Nonregulated Status of MON 95275 Maize (Corn)

A Notice by the Animal and Plant Health Inspection Service on 03/27/2026

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Public Inspection Published Document: 2026-05978 (91 FR 14805) Document Headings ###### Department of Agriculture

Animal and Plant Health Inspection Service

Docket No. APHIS-2025-0021 # AGENCY:

Animal and Plant Health Inspection Service, USDA.

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.

( printed page 14806) 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

Published Document: 2026-05978 (91 FR 14805)