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APHIS Evaluates Petitions Reviewed under 2012 Process, Will Use Process Consistent with USDA Biotechnology Regulations Going Forward
Monday, March 31, 2025

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on March 27, 2025, that it will no longer use the process it outlined in 2012 for reviewing petitions seeking a determination that a modified plant should not be subject to the regulations for the introduction of organisms altered or produced through genetic engineering (modified organisms) that are plant pests or that there is reason to believe are plant pests. On March 6, 2012, APHIS announced that it would publish two separate Federal Register notices for petitions for which it prepares an environmental assessment. 77 Fed. Reg. 13258. The first notice would announce the availability of the petition, and the second notice would announce the availability of APHIS’ decision-making documents, providing two opportunities for public comment. According to APHIS’ March 2025 announcement, at the time, APHIS anticipated that enabling earlier public engagement on the petition would help scope the subsequent analyses, including whether the petition raised substantive new issues. After evaluating the 34 petitions reviewed under the 2012 process, APHIS states that it “found that the first comment period has not yielded comments that significantly impacted the scoping for APHIS’ evaluation.” Given this experience, APHIS will institute the following process consistent with USDA’s biotechnology regulations:

  • Once APHIS deems a petition to be complete, it will publish a Federal Register notice that will begin a 60-day comment period on the petition and APHIS’ draft evaluation documents; and
  • After the comment period closes, APHIS will review the comments and any other relevant information it receives during the comment period, complete its evaluation documents, and make a final determination. APHIS will either approve or deny the petition and publish a Federal Register notice announcing the regulatory status of the modified plant and the availability of the regulatory determination and final supporting documents.
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