The plan was developed in response to Executive Order 14081, issued by President Joe Bidon in September 2022, which launched a biotechnology and biomanufacturing initiative that aims to grow the U.S. bioeconomy across multiple sectors, including the health, agriculture and energy industries.
The White House Office of Science and Technology Policy, in coordination with the EPA, USDA and RFA, in December 2022 issued a request for information seeking relevant data and information to held identify regulatory ambiguities, gaps or uncertainties in the Coordinated Framework for Regulation of Biotechnology, particularly as related to new and emerging biotechnology products. The effort aimed to gather information to help regulatory agencies improve the clarity and efficiency of the regulatory processes for biotechnology products as described in the executive order. The information gathering effort helped inform the development of the plan released on May 8.
According to the USDA, the plan helps meet the administration’s goals of ensuring public confidence in the biotechnology regulatory system and improving its transparency, predictability, coordination, and efficiency. It 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 agency said.
The plan identifies five major areas of biotechnology product regulation where these actions will focus, including modified plants; modified animals; modified microorganisms; human drugs, biologics and medical devices; and cross-cutting issues.
The EPA, USDA and FDA said they intend to implement several joint efforts; including by 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.
The new plan is one of several documents the USDA has released related to Executive Order 14081. In March, the agency released a report that outlines its vision to create a more resilient biomass supply chain and an accompanying implementation framework identifying actions it will take in the next year to increase available cultivated biomass, invest in infrastructure involving biobased products, and support the responsible development of the biomass supply chain.
A full copy of the plan, titled “The Coordinated Framework for the Regulation of Biotechnology,” is available on the United Website for Biotechnology Regulation.
