°®¶¹´«Ã½

On behalf of our 30,000 members in the °®¶¹´«Ã½ States and around the world, the American Society for °®¶¹´«Ã½ (ASM) thanks Chairman Morgan Griffith, Ranking Member Kathy Castor, and members of the House Energy & Commerce Subcommittee on Oversight and Investigations for holding today’s hearing to discuss the science and policies concerning biosafety and pathogen research. The °®¶¹´«Ã½ States has a strong track record of safely conducting life-saving research and adhering to the most stringent biosafety and biosecurity standards. This has enabled us to lead the world in science and innovation, and we have saved countless lives through the development of diagnostics, vaccines and therapeutics to target infectious disease threats. ASM recognizes the importance of cutting-edge research on human, animal and plant microbes, as well as our responsibility as scientists to minimize the likelihood that results of experiments with microbes of concern are misused, or that these pathogens accidentally escape laboratory containment. Our scientific society and its members have been actively engaged in policy development and discussions pertaining to biosafety and biosecurity for many years, and we offer a few points for your consideration below.

Policies should be grounded in science and strike an appropriate balance between benefit and risk.
When considering biosafety and biosecurity policies, it is important that they be evidence-based and draw from scientific expertise both inside and outside of governmental agencies to address the security implications of existing, emerging and reemerging infectious disease threats. ASM appreciates the recent recommendations and revisions put forth by the National Science Advisory Board for Biosecurity (NSABB) following a thorough review of policies governing ePPP and DURC that seek to balance benefits with risks. The NSABB appropriately leverages scientific and bioethical expertise to inform these policies. We urge the federal government to take up these recommendations and implement a robust oversight plan for ePPP and DURC.

Federal funding is essential for policies to work.
Policies must be in place not only to promote the responsible and secure conduct of biodefense research in accordance with biosafety protocols, but also to facilitate education, training and support in biosecurity, biodefense and biosafety. But for the policies to work, there must be a commitment from Congress to provide robust, sustained and predictable funding for federal, state and even local agencies to effectively detect and respond to global threats and outbreaks, and for the research ecosystem to ensure facilities and training program are supported.

Research that involves working with enhanced potential pandemic pathogens (ePPPs) must be accompanied by safeguards and conducted under strict biosafety and biosecurity measures in laboratories at the appropriate biocontainment safety level (BSL). The American public can have confidence that research conducted on ePPPs in the U.S. adheres to the highest standards that set the bar for countries around the world. Even with our strong track record in this country, we recognize the need to continually refine and update standards. For American leadership to continue, Congress must invest in the network of high containment laboratories to ensure that the infrastructure is sound, laboratorians are appropriately trained and the work is conducted with minimal risk to both those working in the lab and to the general population. The network is threatened by high operating costs that cannot be met through traditional indirect costs typically associated with extramural grants and contracts, the increasing regulatory burden and the demands for a highly trained workforce. The business model originally envisioned to sustain the network through indirect costs associated with extramurally funded research and development projects has failed to meet the extraordinary operations costs of these unique facilities.

The U.S. must continue to lead internationally.
Novel pathogens with the ability to infect humans have emerged at an increasing rate over the past 20 years, and nearly all have originated outside the U.S. Beyond funding support, policies should facilitate productive engagement among global partners. Research on disease-causing microbes is necessarily international and the health and security of the American public depends on transparent research collaborations and sharing of samples from other countries. We appreciate concerns that policies and practices around the globe do not always align with those here in the U.S. It is critical that the work outside the U.S. occurs at a biosafety level comparable to that which is applied domestically to reduce risk of laboratory accidents or malfeasance. Congress should consider what policy and funding levers can be used to raise the bar for biosafety in other countries, and also how we can bolster diplomacy to provide stronger American leadership on biosafety practices. The risk of accidental releases or purposeful misuse of dangerous pathogens is greater without meaningful engagement between U.S. and our colleagues working in biocontainment around the world. ASM believes it is possible to both protect national security and work with governments and researchers in other countries to ensure that this work is being conducted safely.

Field work is an essential component to understanding pathogens and preventing outbreaks.
In addition to bench science in the laboratory setting, field work plays an important and complementary role in helping us identify and characterize pathogens in order to prevent potential outbreaks. Without the information gained from research in the field, we are blind to emerging threats, of which there are many in wildlife. The SARS-CoV-2 pandemic and others before it have shown us that viruses can rapidly change and adapt. Advanced knowledge of viruses that pose a danger can avert outbreaks in humans and is gained by global surveillance and hypothesis-driven field research. This work tells us where and how a suspect virus is circulating geographically, how the virus is evolving and where and how new species, including humans, may become exposed. Without such insights, options to prepare for or prevent a pandemic are highly constrained. Such work is subject to oversight and biosafety protocols, and the NSABB recently made recommendations to expand oversight of this work. We encourage thoughtful consideration of these recommendations, as well as sufficient federal funding support for this work.

We thank the Subcommittee for consideration of our views. ASM is committed to assisting the Committee, its members, the Congress and the Administration as we continue to consider biosafety, biosecurity and related research policies and practices, as well as lessons learned from the COVID-19 pandemic.

###

°®¶¹´«Ã½ is one of the largest professional societies dedicated to the life sciences and is composed of 30,000 scientists and health practitioners. ASM's mission is to promote and advance the microbial sciences.

ASM advances the microbial sciences through conferences, publications, certifications and educational opportunities. It enhances laboratory capacity around the globe through training and resources. It provides a network for scientists in academia, industry and clinical settings. Additionally, ASM promotes a deeper understanding of the microbial sciences to diverse audiences.