Public Policy

Since the establishment of the Coordinated Framework for Biotechnology Regulation in 1986, U.S. regulatory policies and statutes have evolved across multiple levels in accordance with scientific developments to generate a sophisticated but complex multi-agency regulatory framework. However, the rapid acceleration of progress in the biotechnology field over the past decade has generated increasingly frequent needs to update the regulatory framework. The Obama, Trump, and Biden administrations have each successively directed federal agencies to modernize the Coordinated Framework, most recently via Executive Order 14081 issued in 2022.

Despite these extensive efforts, the U.S. biotechnology regulatory system is still predominantly structured around agricultural and pharmaceutical products. The upcoming explosion of developments in synthetic biology, which will enable new classes of live microbial biotechnology products in applications such as engineered living materials, precision microbiome editing, carbon sequestration, and bioremediation, will once again require extensive updates to the Coordinated Framework that rethink the nature of how biotechnology will interface with our society and environment.

In anticipation of this upcoming challenge, I worked with Mary Maxon and Richard Murray to organize a workshop on ‘Pathways Towards the Safe and Effective Deployment of Engineered Microbial Technologies’ in Feb 2024. This workshop, hosted by Caltech’s Linde Center for Science, Society, and Policy, brought together representatives from the biotechnology industry, scientists and scholars, and federal regulatory agencies to discuss the future of engineered microbial products (particularly those intended for release into the environment) and how to properly regulate them.

A policy report detailing the conclusions from this workshop is available here.