SECURE Rule Vacature Creates Opportunity for USDA to Develop Improved Product- and Risk-Based Agricultural Biotechnology Regulations

After a decades-long process to update U.S. agricultural biotechnology regulations, the U.S. Department of Agriculture (USDA) published their revision to regulations regarding the movement of certain genetically engineered organisms at 7 CFR Part 340 in May 2020. The new regulatory framework, called the SECURE rule, was the first comprehensive revision of federal regulations for genetically engineered organisms since 1987. While the SECURE rule streamlined regulatory review processes for non-exempt plants, it perpetuated a process-based approach to regulation. The U.S. Coordinated Framework for the Regulation of Biotechnology, updated by the White House Office of Science and Technology Policy in 1992, affirmed that federal oversight should focus on the characteristics of the product, not the process by which the product is created.

In spite of this, the SECURE rule continued to rely upon arbitrary distinctions between genetically engineered and non-genetically engineered organisms to choose products for review, rather than tying regulation to the traits of the end product. The U.S. District Court for the Northern District of California vacated the SECURE rule in 2024. Accordingly, USDA reverted its regulatory review processes to align with the regulatory framework in place prior to the SECURE rule. The current state of U.S. agricultural biotechnology regulation remains overly burdensome and fails to allocate resources based on the actual risks associated with genetically engineered organisms. Given the limitations of the SECURE rule and its repeal, this paper argues that USDA should develop new product- and risk- based regulations for agricultural products of biotechnology.

You can read the white paper below: