Policy Recommendations for the Regulation of Engineered Microbes for Environmental Release

Abstract

Engineered Microbes for Environmental Release (EMERs) are an emerging biotechnology sector that is poised to play a significant role in shaping the global bioeconomy through their ability to address challenges related to climate change, environmental remediation and diagnostics, self-regenerating structural infrastructure, and more. However, the current U.S. regulatory system is not well equipped to efficiently regulate EMERs, leading to a large regulatory burden on EMER developers that may not be commensurate with the level of risk associated with the product. Such burdens impede innovation in the EMER sector. In this report, we identify some of the specific challenges that EMER products face in navigating the federal biotechnology regulatory framework, and present actionable policy recommendations to the federal government, the biotechnology industry, and the wider scientific community about how to address these challenges.

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