USDA Is Exploring an Overhaul of its Biotech Regulations

When a U.S. District Court vacated the SECURE rule in 2024, the Animal and Plant Health Inspection Service (APHIS) reverted to its legacy framework for regulating genetically engineered plants, microbes, and other organisms. As the agency considers new rulemaking to withdraw its existing regulations (7 CFR Part 340), it has an opportunity to establish a product- and risk-based regulatory framework that focuses on an organism's characteristics rather than the breeding method used in development.

The Breakthrough Institute submitted a comment to APHIS warning the agency should avoid replicating past reform attempts or substituting one process-based regulatory trigger for another. Instead, Breakthrough recommends APHIS build a tiered, risk-proportionate regulatory system that presumes that no premarket regulation is needed for most new organisms, and that requires review only of organisms with high-risk traits, regardless of how they were developed. Experience with conventionally-bred and genetically engineered crops to date provides enough evidence to treat a wide variety of traits as low-risk. Such an approach would more efficiently use government resources to assess risks in a scalable and proportional manner, as recommended by the National Academies of Sciences; would support innovation by streamlining commercialization of low-risk products; and would provide a regulatory framework that can more easily adapt to new technologies.

Additionally, USDA should proactively request funding for the staff needed to pursue a regulatory overhaul, which often requires additional resources. Otherwise a shift from the current regulatory system would risk creating new bottlenecks in ongoing review processes.