Reading Room Production — page 139

'ch ral lv 18, Page 17 regarding employee disciplines. This section would make people charged with compliance consistently and constantly afraid for their jobs. A punitive reporting process would have the opposite impact that I think is intended. Transparency on situations is important but its unclear what would happen because of these reports. We have significant concerns about this bill and approach this would take for the oversight of biological research. Based on timelines and reviews, plus the lack of appropriate experience, many researchers would likely leave critical research fields and the work would be paused having negative and catastrophic impact to the biomedical enterprise and by extension human and animal health and safety. OSP Topline points: · While some aspects of this bill related to scope are improved, there continue to be significant concerns about the impact on biomedical research. · 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, and its oversight provisions fail to target the subset of research posing greatest risk. 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 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. · As currently drafted, this legislation has the potential to 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: · Scope: While steps have been made toward harmonization of the scope of the Board's oversight with the new United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (2024 OSTP DURC/PEPP Policy), some of the listed experiments in the "dual use research of concern" definition do not match those in the policy, and other articulated in-scope research in the bill including the "gain of function research" term continues to be in conflict with USG policy. These definition differences will be challenging to deconflict for the research community. Many of the USG definitions were determined following significant interagency discussions directed by Congress and informed by the National Science Advisory Board for Biosecurity, public comment, and other expert input. o This could result in delays to critical biosurveillance efforts such as COVID-19 testing, H5N1 monitoring, and detection of emerging outbreaks of Ebola and other diseases. It could also result in delays for development of vaccines, therapeutics, and biomedical, agricultural, and other life sciences research