The Role of Biosafety Professionals in Biotechnology Governance: Assessing Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential

Biosafety professionals operate at the intersection of scientific innovation, governance, and risk management to oversee high-risk biological research. Their work involves mitigating the risk of biological incidents (biosafety) and preventing the misuse of biological agents (biosecurity). Oversight of dual use research of concern (DURC) and pathogens with enhanced pandemic potential (PEPP) shines a light on the complex interplay between these domains. This research examines how biosafety professionals interpret and implement current DURC and PEPP oversight policies in the United States. Using a mixed methods approach, combining qualitative analysis of workshop discussions with quantitative survey data, this research explores epistemic differences in risk perception, regulatory adherence, and decision-making. Drawing on science, technology, and society (STS) frameworks of organizational safety, regulatory compliance, and adaptive risk management, it explores how biosafety professionals balance regulatory compliance, institutional autonomy, and risk mitigation. Findings reveal significant differences in risk tolerance and compliance strategies, with professionals navigating tensions between rigid governance and localized decision-making. This study positions biosafety expertise as a form of regulatory science that both shapes and is shaped by governance structures and contributes to STS debates on the co-production of knowledge and policy. Rather than recommending one-size-fits-all policies, the findings recommend a tiered, flexible oversight model that integrates biosafety expertise into biosecurity governance. This approach would improve risk management and allow for scientific innovation and national security. Additionally, the study advances STS scholarship by examining how biosafety experts navigate regulatory ambiguity and contribute to anticipatory governance in emerging biotechnological risks.