Dear Chairman Babin, Ranking Member Lofgren, Chairman McCormick and Ranking Member Sykes:

On behalf of ASM and our 38,000 members in the United States and around the world, thank you for holding this hearing on U.S. biotechnology leadership and the policies needed to protect both scientific innovation and national security. ASM is one of the largest professional societies dedicated to the life sciences. Our members work across academic, government, industry, clinical and public health settings to advance the microbial sciences and translate discovery into benefits for human, animal, plant and environmental health.

The biological sciences are poised to transform nearly every sector of the economy and fundamentally improve how we prevent and treat disease, produce food, manufacture materials and energy and protect the environment. The McKinsey Global Institute estimates that “as much as 60% of the physical inputs to the global economy could, in principle, be produced biologically.” It further identified approximately 400 scientifically feasible applications that could generate between $2 trillion and $4 trillion in direct global economic impact annually over the next 10 to 20 years. The nations that lead this transformation will shape emerging industries, strengthen critical supply chains, establish global standards and capture significant economic and national security advantages.

The U.S. has the scientific talent, research institutions and innovative capacity to lead this new biological era, but continued leadership is not guaranteed. It will require sustained federal investment in fundamental research, a strong scientific workforce, responsible international partnerships and a regulatory environment that manages genuine security risks without unnecessarily obstructing beneficial research. Policies intended to protect the nation must therefore be judged not only by the risks they address, but also by whether they strengthen or weaken America’s ability to compete.

The U.S. should take credible threats to its research enterprise seriously. ASM supports appropriate safeguards to protect U.S. intellectual property, sensitive research data and taxpayer-funded discoveries from theft, diversion or misuse. Those safeguards should be targeted to identified risks and implemented with scientific expertise. America’s security and competitiveness also depend on remaining the world’s leading destination for scientific talent and a trusted partner in international research. Policies that broadly isolate U.S. scientists or impede legitimate collaboration will weaken the research ecosystem they are intended to protect.

Winning the Biotechnology Race Requires Greater U.S. Investment

The U.S. cannot protect its biotechnology leadership through restrictions alone. The bipartisan National Security Commission on Emerging Biotechnology concluded that the U.S. is falling behind in key areas as China pursues a coordinated, state-backed biotechnology strategy. The Commission reported that federal research and development spending declined from nearly 2% of gross domestic product in the 1960s to approximately 0.6% today. Meanwhile, China has developed more than 100 biotechnology research parks and 17 industrial clusters that connect research, infrastructure and commercialization. 

The competitive shift is already visible. China now conducts more clinical drug trials than the U.S., and Chinese biotechnology companies are increasingly licensing new discoveries to American firms. These trends do not mean that U.S. leadership has already been lost. The U.S. retains exceptional scientists, research institutions, companies and an open innovation ecosystem. They do mean that maintaining leadership requires deliberate national action.

Congress and the Administration should treat federal investment in basic and applied research as a national security priority. Increased support for NIH, NSF, the Department of Energy Office of Science, USDA research agencies and other federal science programs is essential to produce discoveries, develop the biotechnology workforce and move innovations from laboratories into practical use. Cuts, prolonged funding disruptions and policies that discourage international research collaborations will accelerate the erosion of America’s advantage when China is expanding its own capacity.

International Collaboration Strengthens U.S. Health and Security

Microbes do not respect geopolitical borders. Novel pathogens often emerge outside the U.S., and research on disease-causing microbes is necessarily international. Transparent research partnerships, global surveillance and the timely sharing of samples and data allow scientists to identify threats, understand how pathogens are changing and develop diagnostics, vaccines and therapeutics before outbreaks grow into larger emergencies.

ASM recognizes that biosafety and biosecurity practices abroad do not always match U.S. standards. That disparity calls for stronger American engagement and leadership, not less. The U.S. should work with international partners to raise biosafety standards, improve transparency and ensure that research involving dangerous pathogens is conducted under safeguards comparable to those applied domestically. Reducing meaningful engagement with responsible foreign scientists would limit visibility into emerging threats and diminish U.S. influence over global research practices.

Research security measures should therefore focus on conduct, affiliations, access and demonstrated risk. Strong disclosure requirements, appropriate protection of sensitive and proprietary information, cybersecurity, due diligence and enforcement against individuals or institutions that violate the law can protect U.S. discoveries while preserving legitimate scientific exchange. Clear rules will also help researchers and institutions understand their responsibilities and direct compliance resources toward the relationships and activities that present the greatest risk.

Oversight Must Distinguish Dangerous Research from the Broad Use of Gain-of-Function Techniques

ASM shares the goal of preventing research that could create an unreasonable risk to public health or national security. Scientists who study pathogens also have a responsibility to minimize the possibility that experimental results are misused or that pathogens escape laboratory containment. Research involving enhanced potential pandemic pathogens must be subject to rigorous review and conducted at the appropriate biocontainment level by properly trained personnel.

At the same time, “gain of function” is a broad scientific term. It can encompass many routine methods used to understand how organisms work. Gain-of-function techniques have contributed to advances in genetics, vaccines, therapies, insulin production and agricultural resilience. Research that raises heightened biosafety or biosecurity concerns represents a very small subset of experiments using these techniques. Treating the entire category as synonymous with dangerous research would sweep beneficial, low-risk work into restrictions designed for exceptional cases.

The potential consequences are not hypothetical. Reporting based on internal NIH communications found that 11 tuberculosis studies using common microbiology techniques were suspended in 2025 after career scientists had already concluded that the work should not be classified as dangerous gain-of-function research. One affected project created less virulent and less fit versions of tuberculosis bacteria to identify vulnerabilities that could be used to develop new drugs. That research was conducted in a biosafety level 3 laboratory under institutional biosafety review. This example illustrates how an expansive interpretation can interrupt work aimed at making a pathogen less dangerous and developing treatments for it.

The reach of broad restrictions could extend far beyond infectious disease. A scientific commentary published in ASM’s mBio documented gain-of-function approaches used in oncolytic cancer therapies, vaccine development, bacteriophage treatments, crop resilience, nitrogen fixation and industrial biotechnology. The commentary also explained that the vast majority of virology experiments do not involve changes that are expected to enhance a pathogen’s pandemic potential. Losing these tools would weaken sectors of biotechnology in which the U.S. is competing for scientific and commercial leadership. 

This distinction is central to implementation of the President’s Executive Order on dangerous gain-of-function research and related legislative proposals. ASM supports rigorous oversight of genuinely high-risk research. Any federal policy should use clear and consistent definitions focused on the characteristics that make an experiment dangerous, including the pathogen, proposed modification, research purpose, expected outcome, experimental design and containment environment. Reviews should draw on scientists, national security experts and biosafety and biosecurity professionals with hands-on operational experience.

ASM urges the Administration to refine implementation of the Executive Order so that it reaches research presenting a genuine and significant risk rather than the broad use of gain-of-function methods. Agencies should promptly review suspended projects under clear, scientifically grounded criteria and restore funding for work that does not meet a narrow high-risk standard. The Administration should also provide transparent explanations, consistent requirements across agencies and a timely process for researchers and institutions to seek reconsideration.

Congress should closely oversee implementation, including which projects have been suspended, the scientific basis for those decisions and the effects on public health preparedness, medical countermeasure development and U.S. biotechnology competitiveness. In its comments on the Risky Research Review Act, ASM recommended streamlined procedures and review timelines of approximately 30 to 60 days so that oversight does not unnecessarily delay research funding. Indefinite pauses, duplicative reviews or definitions that capture broad areas of microbiology could slow the development of vaccines and other countermeasures and reduce the ability of U.S. researchers to respond to emerging threats.

Effective Biosecurity Requires Investment As Well As Regulation

The U.S. already has a strong system of institutional and federal oversight and a record of conducting life-saving research under stringent biosafety and biosecurity standards. That system must continue to improve as science and technology advance. New requirements will have limited practical value, however, if laboratories lack the facilities, workforce and resources needed to implement them.

Congress and the Administration should pair oversight policies with investments in the nation’s biocontainment laboratory network, specialized workforce training and the agencies responsible for review and enforcement. Aging infrastructure, high operating costs and shortages of trained personnel create real-world safety challenges. Investments that ensure facilities are sound, equipment is operational and personnel are properly trained will directly strengthen biosafety and biosecurity.

Principles for Securing U.S. Biotechnology Leadership

ASM respectfully recommends that federal biotechnology and research security policies:

• Protect U.S. intellectual property, sensitive research information and taxpayer-funded discoveries through targeted, enforceable safeguards based on documented risks.
• Increase federal investment in basic and applied biotechnology research, the scientific workforce and research infrastructure that harnesses microbes to address humanity’s most pressing challenges.
• Preserve responsible international partnerships, global surveillance and the exchange of samples and information needed to identify and respond to biological threats.
• Distinguish the broad use of gain-of-function techniques from the narrow subset of experiments that warrant enhanced review.
• Refine implementation of the Executive Order, promptly reconsider suspended projects and restore support for research that does not meet a narrow, scientifically grounded high-risk standard.
• Use clear, consistent and scientifically grounded definitions across executive and legislative policies.
• Include scientific, national security, biosafety and biosecurity expertise in review decisions, with transparent standards and timely processes.
• Fund biocontainment facilities, workforce training and effective implementation of federal oversight requirements.

The U.S. can protect its research enterprise while remaining open to the people and partnerships that make American science strong. By focusing security measures on genuine risks, sustaining international engagement and supporting the infrastructure and workforce needed for safe research, policymakers can strengthen both U.S. biotechnology leadership and public safety.

ASM appreciates the Subcommittee’s consideration of these views and stands ready to serve as a resource as Congress and the Administration continue to consider biotechnology, research security, biosafety and biosecurity policies. If we can be of further assistance, please contact ASM Government Relations Manager, JR Kane, at jkane@asm.org.

Sincerely,

Stefano Bertuzzi, Ph.D., MPH
Chief Executive Officer
ASM