The National Academies of Sciences, Engineering and Medicine (NAS) Committee on Future Biotechnology Products and Opportunities to Enhance the Capabilities of the Biotechnology Regulatory System has released the prepublication version of a new report, “Preparing for Future Products of Biotechnology.”
The report is part of an effort that was initiated in July 2015 by the White House Office of Science and Technology Policy’s (OSTP) to clarify the roles of agencies responsible in regulating products of biotechnology. The NAS was tasked by the three regulatory agencies (U.S. Environmental Protection Agency, U.S. Food and Drug Administration, and U.S. Department of Agriculture) to look into the future and describe possible future products of biotechnology during the next five to 10 years, as well as providing some insights that can help shape the capabilities within the agencies as they move forward.
The committee has three recommendations in response to these challenges, which it states should be taken to “enhance the ability of the biotechnology regulatory system to oversee the consumer safety and environmental protection required for future biotechnology products.”
First, EPA, FDA, USDA and other agencies involved in regulation of future biotechnology products should increase scientific capabilities, tools, expertise and horizon scanning in key areas of expected growth of biotechnology, including natural, regulatory, and social sciences.
Next, EPA, FDA and USDA should increase their use of pilot projects to advance understanding and use of ecological risk assessments and benefit analyses for future biotechnology products that are unfamiliar and complex and to prototype new approaches for iterative risk analyses that incorporate external peer review and public participation.
Finally, The National Science Foundation, the Department of Defense, the Department of Energy, the National Institute of Standards and Technology, and other agencies that fund biotechnology research with the potential to lead to new biotechnology products should increase their investments in regulatory science and link research and education activities to regulatory-science activities.
