USA Issues Joint Regulatory Plan for Biotechnology

MAY 9, 2024

The US EPA, the US FDA, and the USDA have developed a plan to update, streamline, and clarify their regulations and oversight mechanisms for biotechnology products.

The plan, which is aimed at improving the transparency, predictability, coordination, and efficiency of the biotechnology regulatory system, has been developed through a collaboration of the Agencies and incorporates processes and timelines to implement regulatory reform, and identifies five major areas of biotechnology product regulation requiring attention:

  1. Modified plants
  2. Modified animals
  3. Modified microorganisms
  4. Human drugs, biologics, and medical devices
  5. Cross-cutting issues

The EPA, the FDA and USDA also intend to implement 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 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.