EPA, FDA and USDA release regulatory plan for biotechnology

The U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) have issued developed a biotechnology plan implement regulatory reform, including the identification of regulations and guidance documents that could be updated, improved or clarified, and the identification of potential new guidance or regulations, where necessary.

On September 12, 2022, President Biden issued Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure Bioeconomy,” which aims to accelerate biotechnology innovation and advance America’s bioeconomy across multiple sectors, including service health, agriculture, and energy. The Implementing Regulation aims, among other things, to support the safe use of biotechnology products by clarifying and streamlining regulations in the service of a science- and risk-based, predictable, efficient and transparent regulatory system.

The Implementing Regulation describes biotechnology as “technology that applies and/or is made possible by innovation in the life sciences or product development.”

The new three-agency plan helps achieve the president’s goals of ensuring public confidence in the biotechnology regulatory system and improving its transparency, predictability, coordination and efficiency. By engaging developers and stakeholders and scanning the horizons for novel biotechnology products, the agencies worked together to develop a coherent plan. The plan includes processes and timelines for implementing regulatory reform, such as identifying guidance and regulations that require updating, improvement or clarification and identifying the potential need for new guidance or regulation. The plan supports a whole-of-government approach to regulating biotechnology products.

The agencies have identified five main areas of biotechnology product regulation on which this effort will focus:

  • Human medicines, biological products and medical devices

EPA, FDA, and USDA intend to undertake the following joint efforts:

  • clarify and improve regulatory oversight of genetically engineered (GE) plants, animals and microorganisms;

  • update and expand information exchange under the Memorandum of Understanding to improve and expand communication and coordination of surveillance of engineered microorganisms;

  • undertake a pilot project focusing on engineered microbes to explore and consider the feasibility and costs of developing a web-based tool that informs developers which agency may regulate which product category.

The federal government established the Coordinated Biotechnology Regulatory Framework in 1986 and most recently updated it in 2017. It describes a comprehensive federal regulatory policy designed to ensure the safety of biotechnology products, including the shared responsibility of the EPA, FDA, and USDA for regulating many biotechnology products in the U.S. . The implementing regulation directs the three agencies to improve how they implement the coordinated framework.

In response to the Executive Order, three regulatory agencies, in consultation with the Office of Science and Technology Policy (OSTP), issued a Request for Information (RFI) to the public seeking information on regulatory ambiguities, gaps, uncertainties, or inefficiencies in coordinated framework. The agencies received 88 separate public comments, including a letter of signature from more than 6,000 members composed of biotechnology developers, producers, manufacturers, non-governmental organizations and academia.

The agencies will continue to engage with all stakeholders as the plan is implemented.