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Reading Room Production — page 179

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pathogens already listed what is meant by "synthetic construct" in addition to previous use of "synthetic" and does this mean that using only a piece of a "high-consequence pathogen" (e.g. synthesizing the receptor-binding site and studying receptor affinity in vitro, or synthesizing a viral or bacterial enzyme and studying inhibitors in vitro) would potentially still be considered "high-consequence"? o Subparagraph B is auto-referential creating an exclusion for seasonal influenza unless genetic sequences have been introduced from the list of pathogens that includes influenza A - does this mean that any introduction of genetic material from one seasonal influenza virus into another seasonal influenza virus would be considered "high-consequence"? o Some other included pathogens besides influenza may be commonly circulating in the population, and classifying them as automatically "high-consequence" could potentially delay or interfere with clinical diagnosis and care depending on how the other criteria for centralized Board review are interpreted (e.g. all sarbecoviruses, all mpox viruses). o According to the next section at the bottom of the page, it looks like maybe only experiments that meet DURC/GOF criteria with these agents would need centralized board review, and if it were possible to obtain clarification that non-DURC/GOF experiments are not subject to the Act provisions that might mitigate some of the potential concerns, but there is the possibility that uncertainty about interpretation could still have major impact on willingness to conduct or review research in some of the relevant areas of importance for public health. • The text of the proposed legislation reads as if the Life Sciences Research Security Board could review all life sciences research. Throughout the text of the proposed legislation, the terms used seem to vary between "high-risk life sciences research," which is defined very specifically, and broader terms like "life sciences research." The scope of review seems far beyond what a single Board could reasonably be able to review especially given the broad definition of life sciences research, even if limited to high-risk life sciences research and even with the Board trying to develop expert committees. Creating such a broad scope of review for the Board risk delays of important research, which does not rise to the level of high-risk life sciences research, that could be adequately addressed at a more local or Agency review level and is already subject to laws, regulations, guidances, and policies. Expertise/Board Processes and Makeup • While biosafety expertise is now included, the makeup and processes of the board could introduce a number of issues. For example, the limitations on prior federal service and designation of participation in high-risk research as a "conflict of interest" could limit the board from accessing relevant national security and life sciences expertise. The exclusion of those involved in high-risk research, based on the definition in the draft legislation, could exclude anyone with a current BSL3 or BSL4 program, excluding individuals with key expertise on how to conduct work safely. These limitations may also exclude individuals who work in government with relevant knowledge of intelligence, threat assessments, and biosecurity. 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. and threat assessments. • We also recommend relaxing the limitations on membership of the board and note that a number of the timelines are untenable (e.g., Congressional notification requirements within 3 days of identifying a potential conflict of interest; publishing procedures in the Federal Register within 90 days of the appointment of initial members; etc.). We note that several provisions relating to the

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