Strengthening Gene Synthesis Security: Desired Outcomes and Capabilities

Gene synthesis, the process of creating physical genes based on digital sequence data, is critical for growing the U.S. biotechnology industry. The industry currently relies on voluntary security guidance from government and industry, which may be an inadequate approach to prevent harms while ensuring global competitiveness.

Moving forward, Congress should designate an entity to employ an iterative governance approach to secure gene synthesis. This approach would include engaging stakeholders, implementing a base level of security, conducting exercises to verify implementation and test the limits of security systems, extracting lessons learned, and integrating those lessons into improved security practices (see figure). The designated entity would regularly report progress towards outcomes with the appropriate legislative oversight committee.