EPA, FDA, and USDA Issue Updates to Joint Regulatory Plan for Biotechnology

In response to U.S. President Joseph 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), U.S. Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA) developed a plan to update, streamline and clarify their regulations and oversight mechanisms for products of biotechnology.

Executive Order 14081, issued on September 12, 2022, aims to accelerate biotechnology innovation and grow 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.

On May 8, 2024, EPA, FDA, and USDA released the plan incorporating 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 agencies identified five major areas of biotechnology product regulation where these actions will focus, including modified plants, modified animals, modified microorganisms, human drugs, biologics and medical devices, and cross-cutting issues.

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

• Clarify and streamline regulatory oversight for genetically engineered plants, animals, and microorganisms;
• Update and expand their information sharing through an MOU to improve and broaden communication and coordination of oversight of modified microbes; and
• 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.

For more details about the joint regulatory plan, read the EPA news release.