i- In a press release issued on May 8, 2024, the U.S. Department of Agriculture (USDA) announced that has developed a joint regulatory plan with the U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) to update, streamline, and clarify their regulations and oversight mechanisms for biotechnology products.
- The plan intends to address President Biden’s goals in Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Economy.” 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 agencies have specifically identified five major areas of biotechnology regulation where the plan focuses:
- Modified plants;
- Modified animals;
- Modified microorganisms;
- Human drugs, biologics, and medical devices; and
- Cross-cutting issues
- USDA, FDA, and USDA noted the following joint efforts:
- clarifying and streamlining regulatory oversight for genetically engineered (GE) plants, animals, and microorganisms;
- updating and expanding their information sharing through an MOU to improve and broaden communication and coordination of oversight of modified microbes; and
- undertaking 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.
USDA, FDA, EPA Release Joint Regulatory Plan for Biotechnology
Thursday, May 9, 2024
