USDA APHIS Updates Petition Review Practices for Genetically Engineered Organisms
Thursday, July 31, 2025
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  • On July 9, 2025, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) announced a significant update to its procedures for reviewing petitions seeking a determination of nonregulated status for genetically engineered organisms. These changes aim to align APHIS’s petition review process with recent legal developments, particularly amendments to the National Environmental Policy Act (NEPA) and the agency’s authority under the Plant Protection Act (PPA).
  • Under the revised approach, APHIS will focus its review on whether a genetically modified organism (GMO) poses a greater plant pest risk compared to an appropriate comparator. If the organism is found not to be a plant pest, APHIS will conclude its review and issue a determination that the organism is not subject to regulation under 7 C.F.R. part 340.
  • Historically, APHIS included environmental impact assessments as part of its petition process. However, the agency clarified that this practice was discretionary, not mandatory. The 2023 amendments to NEPA, enacted through the Fiscal Responsibility Act, reinforce this position by specifying that federal agencies are not required to prepare environmental documents for nondiscretionary actions where they lack authority to consider environmental factors.
  • Despite these changes, APHIS will continue to publish draft reviews of petitions in the Federal Register, allowing for public comment before final determinations are made.
  • Keller and Heckman will continue to monitor developments related to NEPA implementation and APHIS’ regulatory authority under the Plant Protection Act.
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