White House Freshens Up Federal Regulation of Biotechnology

July 8, 2015

By Ricardo Carvajal –  

The White House Office of Science and Technology Policy (OSTP) directed the three federal agencies charged with ensuring the safety of biotechnology products (FDA, USDA, and EPA) to undertake a review intended to “improve the transparency, predictability, coordination, and, ultimately, efficiency of the biotechnology regulatory system.”  The review will consist of three elements: an update to the Coordinated Framework for the Regulation of Biotechnology to “help clarify which biotechnology product areas are within the authority and responsibility of each agency;” development of a “long-term strategy to ensure that the system is prepared for the future products of biotechnology;” and the conduct of “an expert analysis of the future landscape of biotechnology products” by the National Academies of Sciences, Engineering, and Medicine.   

As noted by OSTP, the Coordinated Framework was established in 1986 and hasn’t been updated since 1992.  In explaining the need for a review, OSTP pointed to changes in the biotechnology product landscape, a proliferation of regulations and guidance documents by FDA, USDA, and EPA, an apparent lack of public understanding with regard to safety evaluation of biotechnology products, and unnecessary burdens on small companies.  Among other things, OSTP directs the agencies to take measures to ensure that the Coordinated Framework is periodically reviewed and updated going forward.

OSTP’s directive can be expected to have an impact on regulation of bioengineered foods, but not on human drugs and medical devices because those products “are not the focus of the activities described” in the OSTP memorandum.  Given ongoing controversy over certain aspects of regulation of biotechnology, most notably in the area of labeling, there should be significant interest in the OSTP-directed review.  Public meetings are anticipated in the fall, and interested parties are encouraged to sign up to be notified of further developments.