EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology (Catapult’s regulatory round-up – May 2024)

In response to President Biden’s Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” the U.S. Environmental Protection Agency (EPA), the FDA, and the U.S. Department of Agriculture (USDA) have developed a plan for Regulatory Reform under the Coordinated Framework for the Regulation of Biotechnology to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology.

The agencies will focus on five major areas of biotechnology product regulation:

• Modified plants
• Modified animals
• Modified microorganisms
• Human drugs, biologics, and medical devices
• Cross-cutting issues

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

• clarify and streamline regulatory oversight for genetically engineered (GE) plants, animals and microorganisms
• update and expand their information sharing through a memoranda of understanding(MOU ) to improve and broaden communication and coordination of oversight of modified microbes
• undertake a pilot project focused on modified microbes to explore and consider the feasibility and costs of developing a web-based tool that informs developers about which agency may regulate a given product category.

Please find further information here. Published on the 5th of June in Catapult’s regulatory round-up for May 2024.