Reading Room Production — page 111

the intent of the term "GOF" in this bill is to refer specially to research that has the potential to enhance the transmissibility or virulence of a potential pandemic pathogen, for clarity we would recommend the use of the term "pathogen with enhanced pandemic potential" in the 2024 OSTP policy that addresses this type of research, as well as it's associated definition. This would help to avoid the ongoing confusion surrounding the term GOF. · 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 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 membership of the Board or its support staff are vague, including the requirement that Board members be "impartial" and that support staff be prohibited from "directly or indirectly influenc[ing]" the Board. The proposed legislation would also politicize independent peer review by making the constituent members presidential appointees. · Review process: While a path for expedited review has been added, there could still be major issues with continuity of science due to delays of reviews or membership being confirmed. Among other concerns, in particular, this will significantly impede the USG's ability to prepare for and detect emerging infectious diseases/epidemics/pandemics and will also significantly impede the USG's research response to an epidemic/pandemic. We recommend establishing a default rule that research may proceed if a decision is not made within a fixed timeframe to ensure that any lapse in function by the Board (e.g., delays in confirmation) do not result in life sciences research grinding to a halt. We also recommend a formal appeals process and an exemption to public reporting requirements if the information could pose national security risks. · 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: We recommend striking provisions that mandate the provision of security clearances to Board members, Board staff, and members of Congress, or that require these individuals to access and review all classified research funded by any agency. 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. We also recommend that clauses be included to enable the intelligence community to respond to requests from the Board in a manner consistent with the protection of intelligence sources and methods. · Enforcement: The enforcement provisions are extreme and may raise significant legal and privacy concerns. Those provisions mandate a suite of harsh penalties for any violations of certain provisions of the statute, including technical or unintentional 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 could broadly disincentivize individuals from working in life sciences research and funding agencies, which could send research outside of this country and compromise progress