NSCEB Paper Outlines Policy Options to Modernize Oversight of Biotechnology Products

The National Security Commission on Emerging Biotechnology (NSCEB) has published a January 2026 discussion paper entitled “Creating Clear Regulatory Pathways for Biotechnology.” According to the paper, biotechnology regulations in the United States are complex, resulting in a slow process, while regulations in China and other countries allow developers to move ahead more quickly. The paper notes that the regulatory system in the United States is “built on laws that predate biotechnology, and that were not written with the rapid advancement of emerging biotechnology products in mind,” and the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) “has not kept pace with scientific advances, leaving a system marked by regulatory gaps.” Congress could “reduce unnecessary regulatory burden, empower and resource regulators to work efficiently, and uphold safety and transparency for consumers.” The paper includes statutory amendments and regulatory reforms consistent with the following themes:

• Clear roles: Agencies clearly define responsibilities in interagency agreements so both developers and regulators know which agencies are involved and what processes to follow;

• Risk-tiered processes: Agencies sort products into tiers: exempt or fast-track review for familiar products, streamline review for moderate-risk products, and reserve the highest scrutiny for novel products;

• Single point of entry: A short intake form confirms the lead agency and next steps. One application with product-specific annexes enables data sharing and reduces duplication;

• Streamlined review: Agencies coordinate effectively. Along with clear pathways, adequate staffing and focused expertise reduce backlogs and make timelines predictable;

• Continuous improvement: Horizon scanning identifies new products before they enter the regulatory system. Regulatory pilots are used to test new and improved regulatory pathways; and

• Regulatory diplomacy Working with allies and partners on shared solutions, such as international standards, data sharing, and complementary regulatory frameworks, helps to open markets for American-made products.

Last updated in 2017, the Coordinated Framework outlines a comprehensive regulatory policy for ensuring the safety of biotechnology products and summarizes the roles and responsibilities of the U.S. Department of Agriculture (USDA), U.S. Environmental Protection Agency (EPA), and U.S. Food and Drug Administration (FDA) with respect to regulating biotechnology products. The agencies intended to release an updated Coordinated Framework in December 2024 under the Biden Administration but failed to do so. President Trump rescinded former President Biden’s September 2022 Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” and without congressional action, it is unlikely that the Coordinated Framework will be updated any time soon.