The Environmental Protection Agency, the Food and Drug Administration, and USDA have developed a plan to update, streamline, and clarify their regulations and oversight mechanisms for biotechnology products.
The joint plan is intended to ensure public confidence in the biotechnology regulatory system and improve its transparency, predictability, coordination, and efficiency. The new plan incorporates processes and timelines to implement regulatory reform, such as identifying guidance and regulations to update, streamline, clarify, and identify the potential need for new guidance or regulations.
The major areas of biotechnology product regulation include modified plants, animals, and microorganisms, along with human drugs, biologics, medical devices, and cross-cutting issues. The three agencies intend to implement their joint efforts like clarifying and streamlining regulatory oversight for genetically engineered plants, animals, and microorganisms. They will also update and expand their information sharing through a Memorandum of Understanding to improve and broaden communication and coordination oversight of modified microbes.
