RSI Research Seminar

Join us every other Monday at noon for lunch and a 30-minute research talk, presented by Resnick Sustainability Institute Graduate Fellows and Caltech researchers funded by the Resnick Sustainability Institute. To see the full schedule of speakers, visit the RSI Research Seminar web page. Seminars currently take place in a hybrid format, both in-person (in the new Resnick Sustainability Center building!) and via Zoom. For more information and to get the Zoom login info, please reach out to [email protected]

The role of policy and governance in shaping biotechnology for sustainability: A case study of U.S. regulations governing engineered microbes for environmental release

John Marken, RSI Postdoctoral Scholar, Bruce Hay Lab

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 conventional 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 alongside the RSI, 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. The white paper which emerged from these discussions can be found here.

In this talk, I will present the insights from this workshop and discuss additional possible avenues by which rigorous thinking about policy and governance can integrate with the scientific research activities being conducted at Caltech.