Reading Room Production — page 158

• 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. • However, HHS welcomes efforts from Congress to further strengthen biosafety and biosecurity in the life sciences. 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. Scope/Definitions • 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. We recommend that the definitions and scope of review be fully harmonized with the DURC/PEPP policy and not include a separate list of pathogens. Many of the definitions of research that is subject to requirements of this proposed legislation are very broad and not all are in line with existing policies, which is likely to cause confusion in the research community. 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 writ large (including research that is not associated with pathogens or toxins and raises no identified national security threats, such as cancer research). o If the statute only provided the board the responsibility to review federally-funded research involving DURC and PEPP, as defined in the DURC/PEPP policy, it would ensure oversight resources are used most efficiently to assess and mitigate risks to the public while avoiding unintended negative consequences for the nation's biomedical enterprise. We believe this is the intent of the bill but as written the definitions are not harmonized. o A large amount of scientific research involves gain or loss of function; it's a fundamental process in science. For example, some types of immune therapy cause the immune system to gain function to fight against a disease. Unfortunately, the term "gain of function" has often being misconstrued to suggest all research that causes a gain of function is highly risky, which is inaccurate. In fact, most research involving a GOF does not confer significant additional risk or require additional oversight. NIH does not define the term GOF and current federal policy does not define or operationalize the term. The research that requires strict oversight involves enhancing the transmissibility and/or