Reading Room Production — page 165

ORS Concern over the confusion and differences between agent listing, some definition and intent of this as compared to the new DURC PEPP policy and also the current/ transparent process by which select agents are added or removed. We would recommend alignment 100% in line with the current SA policies and DURC PEPP policies. Curious if this Board would be subject to posting in the Federal Register with public comment, or would function in a more draconian approach. Acknowledging that risk assessment is best when diverse voices are heard, the lack and actually clear refusal to ensure persons with experience in high and maximum containment principles are included would not provide a comprehensive and scientifically robust review of this work. The Board would be all political appointees, and finding someone with no experience in this space would likely select for persons who only do not favor this work. The goals feel less neutral and scientifically based and much more politically centric. The agent listings are highly concerning and would have an immediate negative impact to science and public health. The mention of Influenza A viruses, for example, would include all work with H5N1 viruses which are having a significant impact on our poultry and dairy farms. Research into vaccines, treatment, spread and evolution of these viruses is critical to ensure to curb this outbreak and to prevent those in the future. The same could be said for the inclusion of all mpox. The current outbreak and identification of Clade I is highly concerning and without scientists able to pivot nimbly, the outcome is concerning. Page 18 of the document, line 26-30 appear to replace the work of IBCs and IREs and biosafety professionals across the country. The composition of this board would not have the appropriate expertise, training or experience to appropriately determine these requirements. It also seems quite granular for a board of this nature. Concerns about sensitivity of grant and project submissions from the confidentiality side- defer to OER and OSP. 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: Defines an expanded scope of pathogen and toxin research subject to additional oversight by the U.S. Government; 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 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.