WASHINGTON—U.S. Senators Mitt Romney (R-UT), member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and Bill Cassidy, M.D. (R-LA), HELP Ranking Member, along with U.S. Representatives Cathy McMorris Rodgers (R-WA), Chair of the House Energy and Commerce Committee, and Richard Hudson (R-NC), called on the Biden Administration to bolster oversight of research involving dangerous pathogens, which Congress required as part of the PREVENT Pandemics Act. Specifically, the lawmakers urged the Administration to prioritize improving oversight of “gain of function” research, or research involving enhanced pathogens of pandemic potential, and developing a strategy for the management and oversight of federal high-containment laboratories. By law, the Biden Administration must implement these provisions by December 29th.
Since the enactment of the PREVENT Pandemics Act, the Government Accountability Office (GAO) and the National Science Advisory Board for Biosecurity (NSABB) have reaffirmed the need to improve federal oversight of this research and issued recommendations to the Biden administration that align with these policies.
“As you know, in December 2022, the President signed the PREVENT Pandemics Act… [which] intended to address lessons learned from the COVID-19 pandemic response, including improving and enhancing domestic biosafety and biosecurity,” wrote the lawmakers.
“Timely implementation … is critical to enhancing our biosafety and biosecurity,” continued the lawmakers. “Accordingly, we request a briefing for our staffs no later than Friday, June 30, 2023, from members of your staff. The goal of this briefing will be to learn about your progress to date in implementing these two provisions and your plan to fulfill these requirements by the statutory deadline of December 29, 2023.”
Read the full letter here or below.
Dear Director Prabhakar:
As you know, in December 2022, the President signed the PREVENT Pandemics Act (“PREVENT”) into law as Title II of Division FF of the Consolidated Appropriations Act, 2023. PREVENT intended to address lessons learned from the COVID-19 pandemic response, including improving and enhancing domestic biosafety and biosecurity. As part of this effort, the law directs the Office of Science and Technology Policy (OSTP) to undertake two specific activities: (1) develop a strategy for the management, maintenance, and oversight of federal high-containment laboratories (section 2312); and (2) review and update policies for the review and oversight of research involving enhanced pathogens of pandemic potential (section 2315). Your office is responsible for fulfilling both of these requirements by December 29, 2023.
Section 2312 was intended as an initial step toward addressing a longstanding Government Accountability Office (GAO) recommendation that a single federal entity be charged with leading the evaluation and coordination of high-containment laboratory capacity in the U.S. Among other requirements, the law states that your strategy should:
- Describe federal roles and responsibilities related to high-containment laboratories;
- Assess federal capacity needs and summarize existing capacity that is either federally owned or was established through federal funding at non-federal facilities;
- Summarize existing plans to maintain this capacity and describe how agencies determine whether it is necessary to maintain or expand capacity; and
- Describe how federal departments and agencies will coordinate in overseeing this capacity to improve scientific collaboration and reduce any unnecessary duplication of effort.
Section 2315 was intended to capture OSTP’s January 2017 Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO). As written, the provision could also include updates to other policy frameworks, such as policies for the oversight of dual-use research of concern (DURC) at federal and nonfederal institutions. Notably, both GAO and the National Science Advisory Board for Biosecurity, which Congress also codified through PREVENT, have recently issued recommendations to improve both policies with the goal of ensuring a more cohesive framework for oversight of this type of research. Under the law, the updated policy should:
- Include a clear scope to support the consistent identification of research proposals subject to such policy by relevant Federal departments and agencies;
- Provide a framework for such reviews that accounts for safety, security, and ethical considerations related to the creation, transfer, or use of enhanced pathogens of pandemic potential;
- Include measures to enhance the transparency and public availability of information related to such research actives in a manner that does not compromise national security, the safety and security of such research activities, or any identifiable, sensitive information of relevant individuals; and
- Ensure consistent procedures across relevant Federal departments and agencies related to the identification and referral of research proposals.
Timely implementation of sections 2312 and 2315 is critical to enhancing our biosafety and biosecurity. Accordingly, we request a briefing for our staffs no later than Friday, June 30, 2023, from members of your staff. The goal of this briefing will be to learn about your progress to date in implementing these two provisions and your plan to fulfill these requirements by the statutory deadline of December 29, 2023. Thank you for your attention to this request.