Abstract
The new U.S. government policy for oversight of dual-use research of concern and pathogens with enhanced pandemic potential (PEPP) focuses on federally funded research projects that are predicted by the funding applicant to have a nontrivial likelihood of generating a PEPP. This leaves a considerable gap in oversight of nonfederally funded work and research on novel pathogens. The prediction of pandemic risk arising from novel experiments is difficult even for multidisciplinary teams of experts, and a self-reporting system is inadequate as evidenced by past incidents. Creating an independent organization for oversight, inspection, and investigation of research projects regardless of funding source will ensure consistency and transparency in policy implementation and help to build knowledge and best practices for mitigating the risks of accidental outbreaks.