WASHINGTON — Three federal agencies recently unveiled a joint regulatory plan designed to update, streamline and clarify regulations and oversight for biotechnology products.
The Environmental Protection Agency (EPA), the US Food Drug Administration (FDA), and the US Department of Agriculture (USDA) noted that the plan is designed to support a whole-of-government approach to regulation and biotechnology products.
The plan was made following an executive order by President Joe Biden titled “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.”
“Through engagement with developers and stakeholders, as well as horizon scanning for novel biotechnology products, the agencies worked collaboratively to develop a cohesive plan,” a joint statement read.
The agencies identified five areas of biotechnology product regulation where actions will focus on:
- Modified plants
- Modified animals
- Modified microorganisms
- Human drugs, biologics, and medical devices
- Cross-cutting issues
The joint efforts include clarifying and streamlining regulatory oversight for genetically engineered (GE) plants, animals and microorganisms. Next, the agencies want to update and expand their information sharing through a memorandum of understanding to improve and broaden communications and coordination of oversight of modified microbes.
Finally, the three agencies want to undertake a pilot project focused on those 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.
The federal government established the Coordinated Framework for the Regulation of Biotechnology in 1986 and most recently updated it in 2017. It describes the comprehensive federal regulatory policy for ensuring the safety of biotechnology products, including how EPA, the FDA, and USDA share responsibility for regulating many of the products of biotechnology in the United States.
In response to Biden’s executive order, the three regulatory agencies consulted with the Office of Science and Technology Policy (OSTP) and issued a Request for Information (RFI) to the public to solicit information on regulatory ambiguities, gaps, uncertainties, or inefficiencies in the coordinated framework.
The agencies received 88 distinct public comments, including a sign-on letter from over 6,000 members from biotechnology developers, producers, manufacturers, non-governmental organizations, and academia. The agencies will continue to engage with all interested stakeholders as they implement the plan.
