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Animal and Plant Health Inspection Service, USDA.
Notice of availability.
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.
We will consider all comments that we receive on or before April 20, 2026.
You may submit comments by either of the following methods:
The petition, draft plant pest risk assessment, and any comments we receive on this docket may be viewed at www.regulations.gov, 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.
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.
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 § 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 § 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 § 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
6 comments have been received at Regulations.gov.
Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Submitted comments may not be available to be read until the agency has approved them.