FDA, EPA, and USDA Develop Plan to Clarify Biotechnology Regulations

May 9, 2024
This collaborative effort comes in the wake of an executive order from President Biden, aiming to ensure public confidence in the biotechnology regulatory system.

The U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) “have developed a plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology” in response to an executive order from President Biden. FDA’s website has the press release.

The executive order itself lays out “goals of ensuring public confidence in the biotechnology regulatory system and improving its transparency, predictability, coordination, and efficiency.” The plan, created by the agencies working collaboratively, “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 plan supports a whole-of-government approach to the regulation of biotechnology products.”

The major areas of biotechnology regulation the agencies identified to focus their actions include medical human drugs, biologics, and medical devices.

Joint efforts by the agencies that will be implemented as a result of this plan include to “clarify and streamline regulatory oversight for genetically engineered (GE) 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.”

A related Request for Information has been issued to the public “to solicit information on regulatory ambiguities, gaps, uncertainties, or inefficiencies in the Coordinated Framework.”