EPA, FDA, & USDA Issue Biotechnology Regulatory Plan

The US Environmental Protection Agency (EPA), the US Food and Drug Administration (FDA), and the US Department of Agriculture (USDA) have developed a biotechnology plan to implement regulatory reform, including identification of regulations and guidance documents that can be updated, streamlined, or clarified, and identification of potential new guidance or regulations, where needed.

On September 12, 2022, President Biden issued Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure Bioeconomy,” with the goal of accelerating biotechnology innovation and growing America's bioeconomy across multiple sectors, including health, agriculture, and energy. Among other objectives, the executive order aims to support the safe use of biotechnology products by clarifying and streamlining regulations in service of a science and risk-based, predictable, efficient, and transparent regulatory system.

The executive order describes biotechnology as “technology that applies to and/or is enabled by life sciences innovation or product development.”

The new plan by the three agencies helps meet the President's goals of ensuring public confidence in the biotechnology regulatory system and improving its transparency, predictability, coordination, and efficiency. With engagement from developers and stakeholders, and horizon scanning for novel biotechnology products, the agencies worked collaboratively to develop a cohesive plan. The plan incorporates processes and timelines to implement regulatory reform, such as identifying guidance and regulations to update, streamline, or clarify, and identifying the potential need for new guidance or regulations. The plan supports a whole-of-government approach to the regulation of biotechnology products.

The agencies have identified five major areas of biotechnology product regulation where these actions will focus:

EPA, the FDA and USDA intend to implement the following joint efforts:

The Federal Government established the Coordinated Framework for the Regulation of Biotechnology in 1986 and most recently updated it in 2017. It describes the comprehensive federal regulatory policy for ensuring the safety of biotechnology products, including how EPA, FDA, and USDA share responsibility for regulating many of the products of biotechnology in the US. The Executive Order directs the three agencies to improve how they implement the Coordinated Framework.

In response to the Executive Order, the three regulatory agencies, in consultation with the Office of Science and Technology Policy (OSTP), issued a Request for Information (RFI) to the public to solicit information on regulatory ambiguities, gaps, uncertainties, or inefficiencies in the Coordinated Framework. The agencies received 88 distinct public comments, including a sign-on letter from more than 6,000 members from biotechnology developers, producers, manufacturers, non-governmental organizations, and academia.

The agencies will continue to engage with all interested stakeholders as they implement the plan.