- On May 15, 2026, the U.S. Department of Agriculture (USDA) issued a Request for Information (RFI) seeking stakeholder input on the regulatory framework governing modified organisms under the Plant Protection Act (PPA). Comments are due by June 15, 2026.
- The RFI follows significant recent developments in USDA biotechnology regulation. In 2020, USDA’s Animal and Plant Health Inspection Service (APHIS) finalized the SECURE rule, a comprehensive revision to 7 CFR Part 340 that shifted toward a product-based, risk-focused regulatory framework. However, in December 2024, a federal district court vacated the SECURE rule on Administrative Procedure Act grounds, resulting in a reversion to the pre-2020 regulations. USDA’s current request reflects an effort to reassess its regulatory approach in light of that decision and broader policy objectives.
- USDA is specifically seeking input on whether genetically engineered organisms present materially different plant pest risks compared to conventionally developed organisms, and whether the agency should continue to distinguish between them in its regulations. The agency notes that its experience to date has not identified meaningful differences in risk profiles.
- The RFI also invites detailed feedback on stakeholder experience under both the rescinded SECURE rule and the currently operative Part 340 regulations, including regulatory burdens, costs, and barriers to field trials and commercialization. In addition, USDA is exploring whether modified organisms could be regulated under 7 CFR Part 330, which governs plant pests and related articles, instead of Part 340, and what legal, practical, and trade considerations such a shift would entail.
- Keller and Heckman would be happy to assist in preparing and submitting comments in response to this RFI. We will continue to monitor developments.
