Executive Summary

Biological threats from pathogens and toxins have the capacity to cause significant and widespread harm, regardless of whether they are natural or engineered, intentional or unintentional. Although recent news and policy discussions have focused on biological threats that are enhanced or enabled by artificial intelligence (AI), pathogens and toxins can already cause harm without this emerging technology. To counter biological threats regardless of source, policymakers need a range of governance tools and mitigation measures upon which to draw. The first step in building such a toolkit is to understand what the process resulting in biological harm looks like for various scenarios. Then a suite of policy options can be assembled to intervene at points throughout the process.

This report addresses two generalized scenarios that can result in biological harm. The first outlines the steps that a malicious actor may take to intentionally generate and deploy a pathogen or toxin (marked with a target icon throughout the report). The second describes actions that could result in an unintentional laboratory accident during legitimate scientific research (marked with a test tube icon). Each scenario involves completing a series of planning and physical stages, which offer multiple opportunities to build policy toolkits with a variety of mechanisms.

While describing each pathway, this report also takes stock of the many recommendations that have been made to strengthen U.S. biosecurity and biodefense, and maps these to the steps and scenarios where they would apply. In doing so, we identify governance gaps, along with opportunities to address them by implementing new safeguards or improving existing ones. Key findings include:

• Some safeguards apply to both intentional misuse and legitimate scientific research, while others are specific to one scenario.
• Research oversight mechanisms are primarily leveraged against federally funded research, leaving both regulatory and visibility gaps for non–federally funded research.
• Biosafety, biosecurity, and biodefense responsibilities span government missions, departments, and agencies and require increased coordination.
• Effective oversight would benefit from a biological risk framework that clearly and specifically defines concerning outcomes.

The options presented throughout this report are part of a comprehensive toolkit that policymakers can apply across the entire biological risk pathway. These solutions are designed to mitigate biological harm from a variety of sources, including the AI-relevant concerns that are the focus of considerable current attention. By layering safeguards across multiple steps, policymakers can apply the tools described in this report to more effectively address both AI-enhanced and AI-agnostic threats without unduly hindering scientific innovation.

Figure A: Simplified View of Pathways that Result in Biological Harm from a Pathogen or Toxin

_{^{Source: CSET.
Note: Dashed blue line denotes the Planning-to-Physical transition, and red boxes denote harmful outcomes.}}