The Regulatory Landscape for Synthetic Biology

Executive Summary

Biotechnology is regulated in the United States via a mosaic of statutes enforced by three government agencies: Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and United States Department of Agriculture (USDA). This paper provides a broad overview of the United States’ regulatory approach for biotechnology, describing specific pathways for oversight and gaps in regulation. We primarily focus on the EPA’s Toxic Substance Control Act (TSCA) regulation of environmental applications and FDA’s Food, Drug, and Cosmetic Act (FDCA). The majority of synthetic biology products produced by the synthetic biology will likely be regulated by one of these agencies. Anticipating regulatory pathways can inform how experiments are designed to facilitate a smoother assessment process. Researchers may identify ways that their work could inform regulatory gaps (i.e., gene transfer in complex open environments, frequency of off-target events in cell therapies). Finally, researchers can use their expertise to inform regulatory policy or decisions via public comments, meeting with policymakers, or other mechanisms. This document guides researchers towards areas where they can be more involved if they wish to engage in policy more directly. 

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Acknowledgments

Funding for this project was provided by grants from: Rice University’s Synthetic Biology Institute (Matthews and Beth Beason-Abmayr), the Rita Allen Foundation Civic Science Fellow Award (Matthews and Johnson), and the National Science Foundation (#2223678). We thank Rice undergraduate students Elizabeth Craig, Caroline Snider, and Michelle Oyoo Abiero for their assistance in graphic design and referencing.

To access other papers in this three-part series, see “Ethical Challenges and Concerns in Synthetic Biology” and “Exploring Public Engagement Possibilities for Synthetic Biology: An Overview for Research Scientists.” For additional information and related projects, visit the Synthetic Biology website. 

This publication was produced on behalf of Rice University’s Baker Institute for Public Policy. It has not undergone editorial or peer review. Any errors are the responsibility of the author(s) alone.

This material may be quoted or reproduced without prior permission, provided appropriate credit is given to the author(s) and Rice University’s Baker Institute for Public Policy. The views expressed herein are those of the individual author(s) and do not necessarily represent the views of Rice University’s Baker Institute for Public Policy.