Reading Room Production — page 173

Topline points: • Strengthening biosafety and biosecurity oversight of life sciences research is a key priority of this Administration, as outlined in the National Biodefense Strategy. We believe the bill as drafted would significantly undermine life sciences research without commensurate security benefit. As such, we do not support this legislation. • The Administration has recently strengthened, streamlined, and expanded oversight of potentially high risk life science research in the May 2024 United States Government Policy for Oversight of Dual Use Research of Concern Pathogens with Enhanced Pandemic Potential ("DURC/PEPP policy"). This policy expands and strengthens a tiered system of oversight for all federally funded research that includes a requirement for research on pathogens with enhanced pandemic potential to undergo extra departmental review. The policy also: o Defines an expanded scope of pathogen and toxin research subject to additional oversight by the U.S. Government; o Provides a unified framework to support the consistent identification and oversight of research proposals that require enhanced oversight that accounts for safety, security, and ethical considerations; and o Delineates the roles and responsibilities of principal investigators, research institutions, and Federal departments and agencies that conduct, fund, or oversee research within the scope of the policy. • The Administration also strongly believes in the importance of ensuring the highest level of integrity in scientific and technological processes, and has supported the establishment and enforcement of policies that maintain integrity in the conduct of scientific research and in the collection of scientific or technological data. In support of this, the Administration published a report on Protecting the Integrity of Government Science in January 2022. • The bill seems to create redundancies with some reforms recently introduced by the DURC/PEPP policy, which was developed following significant interagency discussions directed by Congress and informed by the National Science Advisory Board for Biosecurity, public comment, and other expert input. • The bill retains a number of problematic details that could negatively impact innovation and the U.S. competitive edge in life sciences research, including our ability to attract and retain the best scientists. • However, the Administration welcomes efforts from Congress to further strengthen biosafety and biosecurity in the life sciences. o For example, we would welcome discussions on how the risk-based oversight processes established in the DURC policy for federally funded research could be extended to non-federally funded research. • We recognize that biosafety and biosecurity oversight responsibilities are currently shared across many different departments and agencies and welcome discussions on appropriate entities for oversight of the highest risk research. Some of our concerns with the bill are: