°®¶¹´«Ã½

The Honorable Gary Peters Chair, U.S. Senate Committee on Homeland Security and Governmental Affairs 340 Dirksen Senate Office Building Washington, D.C. 20510

The Honorable Rand Paul Ranking Member, U.S. Senate Committee on Homeland Security and Governmental Affairs 295 Russell Senate Office Building Washington, D.C. 20510

Dear Senators Peters and Paul:

°®¶¹´«Ã½ (ASM) recognizes the important role of Congressional oversight of U.S. taxpayer funded research. As Chairman Peters mentioned in his opening statement at the Senate Homeland Security and Governmental Affairs Committee hearing on July 11, it is important to strike a delicate balance between fostering scientific progress and minimizing potential harms of high-risk life sciences research. The framework for regulating research with pathogens with enhanced pandemic potential or dual use research of concern has served the nation well, and there is already a robust system in place at the institutional, local, state and federal levels. However, there’s widespread acknowledgement of the need to improve these processes. 

While the recently introduced Risky Research Review Act (S.4667) acknowledges the importance of research involving pathogens with pandemic potential, the framework it establishes also raises a number of concerns. For example, the bill’s definitions of key terms, such as "dual use," "gain of function research," "high-risk life sciences research," and "potential pandemic pathogen," are unclear and inconsistent with other federal definitions. As a starting place, we recommend that you consider the definitions included in the White House Office of Science and Technology Policy's guidance “°®¶¹´«Ã½ States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential” that was released on May 6, 2024. To avoid sweeping whole new swaths of research into unnecessary regulations, we recommend that oversight focuses solely on high-risk research. 

ASM members recognize the importance of public confidence in the biosafety and biosecurity of research being conducted. The proposed Life Sciences Research Security Board must have the requisite scientific expertise to be effective. We recommend including multiple biosafety and biosecurity professionals with hands-on operational experience to the proposed board and establishing clear criteria for selection to ensure a balanced representation of scientific expertise, national security experts and biosafety and biosecurity professionals. Given the public health risks we continue to face, it is imperative that any new review process not slow down research funding. We recommend streamlined procedures for the review process and setting clear timelines for decisions to ensure that the review process does not exceed a reasonable time frame (e.g., 30-60 days). 

Finally, the bill authorizes an appropriation of $30 million to establish a regulatory structure to carry out the work established by the bill. That will be important should the bill move forward. More importantly, however, the bill is silent on the need to provide funding for the network of the nation’s biocontainment labs and specialized workforce training to ensure that ongoing work is being conducted in the safest way possible. Such investments will have an important real-world impact on biosafety and biosecurity.

Thank you for the opportunity to provide feedback on the Risky Research Review Act. Science is the best defense mechanism to protect us against and respond to the next pandemic. We look forward to working with you to balance fostering scientific progress and minimizing potential harms of high-risk life sciences research. If we can be of further assistance, please have your staff contact Nick Cox, Senior Federal Affairs Officer at the American Society for °®¶¹´«Ã½, at ncox@asmusa.org.

Sincerely,


Amalia Corby
Director of Federal Affairs
American Society for °®¶¹´«Ã½