Preparing for Future Products of Biotechnology
What will the likely future products of biotechnology be over the next 5–10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? A report by the US National Academies of Sciences, Engineering, and Medicine.
The Coordinated Framework for the Regulation of Biotechnology is the U.S. government’s mechanism for providing oversight for the diverse array of products of biotechnology that are being brought to market in a manner that protects health and the environment. In light of some of the recent advances in biotechnology, including in genome editing, gene drives, and synthetic biology, the federal government is in the process of making much needed updates to the Coordinated Framework, which had its last major revision in 1992. The task of this committee was to look into the future and describe the possible future products of biotechnology that will arise over the next 5–10 years, as well as provide some insights that can help shape the capabilities within the agencies as they move forward. Given the rapid (and often unforeseen) advances of the past 5–10 years, it is clear that making accurate predictions of what will be possible is a difficult task, but some trends are clear: there will be a profusion of new products that will in many cases be very different in terms of their type, scope, and complexity, and the number of actors who will be able to contribute to biotechnology will be even more diverse as engineering biology becomes accessible to a broader range of actors. At the same time, there is increased public awareness (and in some cases controversy), and the regulatory agencies are faced with the challenge of balancing the many competing interests from industry, society, government, and academia.
This report reflects the committee’s deliberations regarding the future products of biotechnology that are likely to appear on the horizon, the challenges that the regulatory agencies might face, and the opportunities for enhancing the regulatory system to be prepared for what might be coming. The committee reached consensus on conclusions and recommendations that are based on extensive information gathering, committee discussions, and input from a wide variety of communities interested in biotechnology. The committee contained a diverse set of experts, including individuals with experience in natural sciences and engineering, law and public policy, social sciences, and risk assessment.