The US Environmental Protection Agency (EPA), US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) have issued a joint regulatory plan for biotechnology.
Issued in response to President Joe Biden’s Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe and Secure American Bioeconomy,” the regulatory plan was aimed at updating, streamlining and clarifying the agencies’ regulations and oversight mechanisms for biotechnology products, the FDA said on 8 May.
The plan would cover five major areas of biotechnology product regulation:
- Modified plants
- Modified animals
- Modified microorganisms
- Human drugs, biologics and medical devices
- Cross-cutting issues
The agencies said they planned to work together to introduce the following joint policies: clarifying and streamlining regulatory oversight for genetically engineered (GE) plants, animals and microorganisms; updating and expanding their information sharing through a memorandum of understanding (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.
Established by the Federal Government in 1986 and updated in 2017, the Coordinated Framework for the Regulation of Biotechnology 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 biotechnology products in the USA. The executive order directs the three agencies to improve how they implement the Coordinated Framework.
In response to the executive order, the three regulatory agencies, in consultation with the Office of Science and Technology Policy (OSTP), issued a Request for Information (RFI) to the public to gain information on regulatory ambiguities, gaps, uncertainties or inefficiencies in the Coordinated Framework.
In response to the request, the agencies received 88 public comments, including a sign-on letter from over 6,000 members comprising biotechnology developers, producers, manufacturers, non-governmental organisations and academia.
