APHIS Announces Update to Practices for Determination of Nonregulated Status for Organisms Altered or Produced Through Genetic Engineering

The U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) is updating its process for reviewing petitions that see a determination of nonregulated status for organisms altered or produced through genetic engineering under 7 C.F.R. part 340. These updates ensure that APHIS' petition process aligns with recent developments related to the National Environmental Policy Act (NEPA) and APHIS' authority in the Plant Protection Act (PPA).

APHIS uses 7 C.F.R. part 340 and the PPA to regulate modified organisms that could potentially pose as plant pests. If APHIS determines, through a factual and scientific review, that a modified organism is unlikely to pose a greater plant pest risk, it grants a nonregulated status. Once this status is granted, APHIS's jurisdiction under these regulations ends, and it cannot impose further conditions or consider environmental impacts, even though it has historically conducted environmental assessments. The agency's practice of conducting NEPA analysis does not mean that it is obligated to conduct such analysis.

The United States Congress amended NEPA in 2023 to add a section describing the circumstances under which federal agencies are not required to prepare environmental analyses. On May 29, 2025, the U.S. Supreme Court reiterated the "NEPA canon" that "where an agency has no ability to prevent a certain effect due to its limited statutory authority over the relevant actions, the agency cannot be considered the legally relevant ‘cause' of the effect."

According to the APHIS news release, when evaluating requests for nonregulated status, APHIS will first determine if a modified organism poses a greater plant pest risk. If it is found to be not a plant pest, APHIS will conclude its review and must grant nonregulated status, as it lacks further jurisdiction. APHIS will continue to solicit public comment on draft reviews before making final determinations.

For more details, read the news update on the APHIS website.