Reading Room Production — page 174

• Scope: The legislation continues to codify a list of pathogens, which would reduce the flexibility of funding agencies to adapt to changes from natural and anthropogenic evolution. It also continues to enable the board to review routine life science research outside of the "high risk" definition on a case-by-case basis, and it is unclear how this would be implemented in practice without significantly impacting research review timelines. • Board processes and makeup: 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 and threat assessments. • Review criteria: The bill does not articulate a principle or threshold that guides whether the board should or should not approve a study for funding - for example, should the Board approve research where it determines that the potential public health benefits of the research outweigh the potential risks to U.S. national security? Or should some other standard govern the Board's review? Any statute mandating this style of review should clarify the applicable standard. • Classified review and intelligence concerns: The legislation continues to authorize the board to access and review all classified research funded by any agency, including nonlife sciences research. Those provisions extend beyond the scope of oversight that is reasonable for this board to take on and they may impinge on the constitutional authority of the Executive to control classified national security information. • Enforcement: The enforcement provisions are extreme and may raise significant legal and privacy concerns. Those provisions mandate a suite of harsh penalties for violations of certain provisions of the statute, including technical violations; they allow for no flexibility in determining the severity of punishment; they provide the aggrieved party with no process; and they mandate public identification of aggrieved individuals. These provisions may dissuade scientists from pursuing any research that might be potentially considered high-risk. • Authorities: Agencies have raised concerns about how the legislation would conflict with and impede their existing authorities, including those related to grantmaking. For example, DOD has noted the legislation would curtail DOD's flexibility and weaken DOD's Title 10 authorities to fund research that is in the best interest of national security. In several places the legislation raises privacy concerns by requiring sharing of information that is normally protected under the Privacy Act. In addition, USAID has noted that ambiguity in the definition of federal funding could imply that contributions to other bodies such as CEPI are required to go through this process, which could limit U.S. Government's ability to effectively work with such organizations.