Eight Commonsense Actions
Eight Commonsense Actions on Biosafety and Biosecurity
J. Stephen Morrison and Michaela Simoneau | 2023.11.21
Today, there is a shared sense of vulnerability and a shared resolve across political divides to better protect the United States and the world against the accidental release of biological agents (biosafety), deliberate misuse of biological agents (biosecurity), and naturally occurring spillover of dangerous pathogens.
Biosafety and biosecurity have become more urgent U.S. priorities in the post-Covid era, tied to U.S. national security interests. They have been visibly elevated in U.S. security doctrines, structured around the risks, threats, and vulnerabilities that arise at home and abroad.
For decades, the United States has been in a conventional arms race. Now, that race also focuses intensely on biotechnology that could bring major benefits but, in the hands of nefarious actors, also could cause enormous harm. An alarm has sounded, in part due to heightened awareness of the remarkable speed of scientific and technological changes that are unfolding, including the advance of converging technologies such as artificial intelligence (AI). Furthermore, high-containment laboratories are rapidly expanding around the world, including in low- and middle-income countries — a process that has accelerated dramatically in the post-Covid moment. The sudden proliferation of facilities elevates risks and the demands for improved training, standards, and systems of detection and oversight. Advanced science is now conducted by a highly diverse set of individuals and organizations, including militaries, large biopharmaceutical firms, and countless start-ups that operate quite independent of government. A widely underappreciated dimension is the massive scale of illegal and legal cross-border wildlife trade, often linked with illicit networks transiting people, drugs, and finances. Together, these trends lower the barriers for bad actors to access potentially dangerous biological knowledge.
In mid-2023, the CSIS Bipartisan Alliance for Global Health Security’s Working Group on R&D Innovation concluded that biosafety and biosecurity should be a priority focus of its efforts for the balance of the year. To that end, five highly productive working group meetings were held between July and early October 2023 (see appendix for details).
Important policy reviews are underway within the U.S. government to carefully reassess the evolving threat environment. There is debate over what should be the new balance required between controlling risk and promoting gains in the life sciences that will improve and save lives. There is an urgency to better understand the strengths and vulnerabilities of U.S. biosafety and biosecurity approaches and to rethink how to overcome vexing implementation and coordination challenges across a fragmented government and a complex interface among the U.S. government, industry, foundations, partner governments, nongovernmental groups, and international institutions. Policymakers are also debating what communications capabilities are required to effectively reach U.S. citizens and all entities working in the health security research and development (R&D) community in an age of pervasive mis- and disinformation.
Two important questions remain unanswered: First, who is mandated to set policy and ensure authoritative leadership, including effective coordination and oversight across the U.S. government and with partners outside government, including international partners? Second, will the U.S. government augment staff and programs across multiple departments and agencies with adequate, sustained budgets to ensure they have an effective, sustained capability to implement policy? Far too often, as seen at the Department of Health and Human Services (HHS) and elsewhere, unfunded mandates in the critical areas of biosafety and biosecurity remain so weakly staffed and financed that they create only the appearance, and not the reality, of seriously meeting emerging challenges.
Through its deliberations, the working group has engaged with U.S. government experts, industry leaders, international organizations, and other stakeholders to weigh this question: What concrete actions can and should the U.S. government undertake in the coming few months to strengthen U.S. and global biosafety and biosecurity?
Below are eight commonsense actions proposed by the working group that attempt to answer this question. Many imply an increase in staff, programs, and budgets, but in the larger picture these are modest investments. None are excessive or unaffordable. An expedited costing exercise is an important next step.
What concrete actions can and should the U.S. government undertake in the coming few months to strengthen U.S. and global biosafety and biosecurity?
These eight actions can attract political support across the aisle and from industry, foundations, and other partners. They will have meaningful impacts in preventing and mitigating future accidental or deliberate biological events and strengthen approaches aimed at controlling naturally occurring pathogens. No less important, they will clarify who in the White House is in charge of setting national policy and how sustainable implementation capacity will be established and funded across the U.S. government over the long term. Several pending pieces of legislation provide opportunities to advance these actions, such as the Pandemic and All-Hazards Preparedness Act (PAHPA), the Medical Supply Chain Resiliency Act, and the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act.
If carried forward through consistent high-level political leadership, these pragmatic reforms hold the promise of generating momentum and common purpose. If successful, they will open the way for deeper structural changes in U.S. policy that will position the United States to continue in its role as a responsible leader in advancing a safe, secure, and innovative global bioeconomy for decades to come.
Action 1: The White House should finish the job on time of updating and integrating the U.S. Potential Pandemic Pathogen Care and Oversight (P3C0) Policy and Dual-Use Research of Concern (DURC) Policy.
Updated, strengthened, and unified guidelines for research on enhanced potential pandemic pathogens (ePPPs) are overdue. Combining the two policies is a sound idea. These policies should be consistent with the impressive early 2023 National Science Advisory Board for Biosecurity recommendations, take account of the extensive subsequent consultations that have been held, and reflect the valuable input received from the request for information issued by the White House Office of Science and Technology Policy in October 2023. As mandated by Congress, this process is meant to be completed by the end of 2023. Hewing as close to that timeline as possible will be consequential in demonstrating resolve.
Action 2: The national security advisor should designate a lead on biosafety and biosecurity policy from either — or as a shared responsibility of — the National Security Council (NSC) Directorate for Health Security and Biodefense or the new White House Office of Pandemic Preparedness and Response Policy (OPPR).
At present, it is unclear to many expert observers who is mandated to lead on U.S. policy on biosafety and biosecurity — a refrain heard repeatedly across the CSIS bipartisan alliance working group meetings. To some degree, this reflects that White House policy on biosecurity and biosafety is not managed or communicated effectively across the U.S. government or to external partners. The mission of transforming U.S. pandemic preparedness and biodefense capabilities should be managed with the seriousness of purpose, commitment, and accountability of the Apollo program.
OPPR was created to make major contributions in several areas of health security; it is still positioned to do so as long as the White House builds it consistent with the authority, spirit, and vision of the originating legislation. Both the NSC directorate and OPPR need to ensure that there are an adequate number of expert staff to carry out the expanded agenda laid out here.
The White House, in coordination with the Office of the Director of National Intelligence (ODNI) and departments and agencies, can and should complete a horizon-scanning exercise and clearly define a hierarchy of risks that identifies and explains the most significant threats for the nation and the world. What are the uncontrollable potential pandemic pathogens and the broad societal implications of greatest concern? How should the United States prioritize those pathogens that pose the greatest societal risks while recognizing new, presently unknown threats likely to emerge?
The White House, working with ODNI and other partners, can and should be responsible for iteratively assessing the threat landscape, accounting for scientific and technological changes along with the reemergence of dangerous pathogens and arrival of new infectious disease threats. A special effort should be made to strengthen U.S. biosecurity intelligence capabilities. The White House is uniquely positioned to direct new capabilities that not only reduce the highest-priority risks but are also beneficial in addressing other bacterial and fungal threats, including drug-resistant pathogens.
The White House should work with senior-level, designated, visible counterparts at HHS, the Department of Defense (DOD), and other agencies to harmonize the special capabilities of different departments, prioritize investments, and eliminate redundancies. A subgoal should be to review existing layered biosafety and biosecurity protections with the aim of eliminating those that are ineffectual and elevating those that most effectively address priority risks across life sciences research, biotechnology development, and biomanufacturing activities.
The White House is best positioned to drive and integrate the capabilities of the security sector — including its ability to analyze signals and manage massive volumes of data — with the health and biological domains. These efforts should also be coordinated with industry and academic partners in support of the U.S. National Biodefense Strategy and Implementation Plan and the vision to create medical countermeasures (MCMs) for all potential pandemic pathogens. It should conduct periodic exercises to evaluate U.S. pandemic preparedness, including preparedness for deliberate and accidental outbreaks, by deploying national capabilities, including rapid product development.
Action 3: The U.S. government should mandate universal screening of DNA synthesis orders and create incentives to make implementation achievable. It should also extend the voluntary research norm of “know your customer” beyond DNA products to all private sector biotech providers of goods and services.
The U.S. government needs to strengthen oversight of and safeguards for DNA synthesis providers, particularly as new benchtop synthesis technologies evolve and become far more readily accessible outside of major laboratories. Private industry is reportedly asking for mandated screening of DNA synthesis orders to ensure responsible actors are not financially penalized for implementing safeguards of their own volition.
In the Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, President Joseph Biden directed the U.S. government to establish a framework to encourage providers of synthetic DNA to screen orders for potential national security risks. The government will engage with industry partners to refine best practices for technical implementation, clarify reporting mechanisms, and encourage voluntary compliance. It will also mandate compliance for companies that receive federal funding. This important step by the White House should be strengthened through additional legislative action.
Various other incentives for private sector biotech, such as financial offsets or tax incentives, particularly for those who do not receive government grants and contracts, could help expedite the transition by making compliance with such regulatory standards financially viable for DNA providers. Other forms of active support could be valuable, such as improving training on the responsibilities of industry for biosecurity and establishing an advice center to assist in adjudication of orders that have an ambiguous biosecurity risk.
The U.S. government should expand the guidance that biotech companies “know your customer” to all biotech industry providers of goods and services, including those that create custom molecules, modify strains, and allow for the outsourcing of key lab work. Such companies provide critical scientific resources and knowledge for their downstream customers and therefore serve as important control points to guard against misuse.
Action 4: All federal government investments and grants in infectious disease research on potential pandemic pathogens — in the United States and internationally — should require a dedicated and integrated investment in biosafety and biosecurity safeguards, including applied research and innovation by design.
HHS should designate a visible, active, senior-level lead who is responsible for integrating biosecurity and biosafety investments into grants and contracts for life sciences research, biotechnology development, and biomanufacturing, in accordance with Section 9 of the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.
This is an essential step if new norms and standards for biosafety and biosecurity are to be adopted and routinized, if a biosafety and biosecurity innovation ecosystem is to be created, and if a skilled biosafety and biosecurity discipline is to be established. Investments in biosafety and biosecurity research and innovation can also help keep pace with emerging biological risks associated with rapid technological advances by developing effective safeguards and risk management tools. This goal could be realized if a modest percentage (1–4 percent) of the research grants from the National Institutes of Health (NIH) and other U.S. government agencies on infectious diseases in the viral families with pandemic potential is dedicated to biosafety and biosecurity, with research and risk assessment built into the initial proposal design. In addition, there should be a separate pool of funding to conduct biosafety research, which could include wet lab work involving pathogens as well as work outside containment settings involving the physical sciences, the life sciences, the social sciences, and human systems research. These investments will deepen the grasp of what it takes to create reproducibility, identify recurrent mistakes, increase efficiency, and move toward embracing a bold target of no lab-linked uncontrolled outbreaks of potential pandemic pathogens.
These same requirements should also be built into U.S. global research funding on potential pandemic pathogens, including Pandemic Fund grantmaking, and into the operations of executive agencies carrying out infectious disease work. International norm-setting organizations including the World Health Organization (WHO), the European Health Emergency Preparedness and Response Authority (HERA), and the International Biosecurity and Biosafety Initiative for Science (IBBIS) will play an important role. This approach may be modeled, in part, on how the Human Genome Project built in funding for ethical considerations and how the Advanced Research Projects Agency for Health (ARPA-H) and the Defense Advanced Research Projects Agency (DARPA) have pressed for research projects to take account of ethical, legal, and societal implications.
Action 5: The U.S. government should pursue a far more muscular diplomacy to secure biosafety and biosecurity safeguards globally.
In every area of U.S. domestic policy in biosafety and biosecurity, there should be a conscious and deliberate effort to explain how innovations tie to U.S. diplomacy to strengthen capabilities with external partners. U.S. domestic policy is often developed with little regard for the global context, yet it is frequently, in practice, a de facto baseline for the world. U.S. global programs cannot be treated as an add-on; rather, the U.S. approach to advancing biosecurity and biosafety must be seen as an integral component of a strategy that can be implemented in a wide range of resource-rich and resource-limited settings. The demand for U.S. technical expertise, best practices, and training is rising steeply as middle-income countries in particular invest in an exceedingly swift expansion of high-containment laboratories. Building effective partnerships across the range of areas detailed below requires sustained outreach and engagement; a commitment to equity, access, technology transfer, and strengthening of local and regional capabilities; a belief in combining bilateral and multilateral strategies; and an upgraded communications capability to combat mis- and disinformation against U.S. programs and affirm and promote responsible scientific research.
U.S. global programs cannot be treated as an add-on; rather, the U.S. approach to advancing biosecurity and biosafety must be seen as an integral component of a strategy that can be implemented in a wide range of resource-rich and resource-limited settings.
A U.S. diplomacy of expanded U.S. global investments in biosafety and biosecurity will strengthen bilateral partnerships and global norms and standards. As several U.S. government agencies and programs already conduct work in these areas, the challenge now becomes how to create far more coherence, vitality, and visible unity of effort through both the newly launched Department of State Bureau of Global Health Security and Diplomacy and the Bureau of International Security and Nonproliferation; the U.S. Centers for Disease Control and Prevention, particularly the Division of Select Agents and Toxins program; the HHS Office of Global Affairs; the U.S. Agency for International Development; and the DOD Biological Threat Reduction Program, among others.
U.S. diplomacy should prioritize the following activities:
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Require biosecurity and biosafety investments as integral components across U.S. global health and health security policies and programs, especially those providing laboratory, surveillance, and workforce capacity to combat infectious disease threats. This work to strengthen and build capacity and standards, particularly in low- and middle-income countries, is critical to sustain, detect, and respond to naturally occurring threats.
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Invest in multilateral institutions to strengthen routine and emergency biosafety and biosecurity efforts and reduce vulnerabilities outside U.S. borders. Activities should include investment in the WHO and close support for the UN Office for Disarmament Affairs, including the Biological Weapons Convention.
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Engage systematically with China and the G20 on biosafety and biosecurity norms. No credible U.S. global strategy can ignore China. That said, this goal will require careful, incremental bilateral efforts to address key challenges and involve navigating existing tensions with China and the deep hostility toward China in the United States. The United States will also need to cultivate a coalition of like-minded global partners, including across the G20, and work with other regional partners — including Singapore, Vietnam, India, and Indonesia — and multilateral institutions to test what pressure points and forms of engagement with China would be most fruitful. The November 15 meeting between President Biden and Chinese president Xi Jinping in San Francisco and the Asia-Pacific Economic Cooperation (APEC) Leaders’ Week that followed may create new opportunities for dialogues in 2024 on biosafety and biosecurity, including under the auspices of new talks on the risk associated with AI. Those possibilities should be systematically tested.
The United States should also engage with and support promising new lines of international work in biosafety and biosecurity as they evolve, define the gaps they will fill, and demonstrate concrete returns. Two nascent developments are of particular note:
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The Coalition for Epidemic Preparedness Innovations (CEPI) is working to leverage its laboratory, manufacturing, and preclinical animal model research networks in partner countries to catalyze responsible capacity building with a focus in the Global South. Through U.S. support to CEPI’s vision to develop MCMs for all potential pandemic pathogens, it will be important to ensure that biosecurity and biosafety investments are integrated as explicit priorities.
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IBBIS aims to provide tools and best practices to biotech industry, academia, funders, governments, and other global stakeholders to improve biosecurity and biosafety by safeguarding the tools of modern bioscience and biotechnology. Although IBBIS will be a nongovernmental organization, it will potentially advance key U.S. biosecurity and biosafety goals and raise the bar globally. Support for IBBIS should include using U.S. diplomatic convening power and technical expertise to build international political support for the organization and its work. Under the management of IBBIS, a bio funders’ compact with philanthropic and other private donors could be valuable in strengthening norms and incentives for compliance with biosecurity best practices.
Action 6: Create rules of the road for U.S.-supported viral discovery work.
Both U.S. civilian and military institutions have funded field research in remote settings, often in bat caves, to search for new viruses with pandemic potential. But while research on naturally occurring pathogens remains critical, much more careful U.S. guidance is needed in the form of enforceable and effective rules to assess, permit, and fund this type of work. Clearer standards are needed to weigh the possible scientific benefits, identify the potential dangers, determine whether those risks can be mitigated, and judge whether the work can be pursued responsibly. Protocols should be established for field research and sampling before specimens reach the lab. Once new pathogens are discovered, there should be clearer guidance around the personal protective equipment (PPE) standards required and the biosafety level appropriate to handle such unknown, novel risks. Guidance could also be developed for communities on how to avoid interactions that could lead to zoonotic spillover.
In the post-Covid era, funders and scientists have turned away from funding research on potentially dangerous viruses to a significant degree, in part out of fear of accusations of lab leaks. New, more effective rules will be an essential element in sustaining responsible future research and should be developed based on consultation with experts inside and outside government to ensure standards are reasonable, evidence-based, and not subject to political interference.
Action 7: Invest in research on a rolling, iterative basis on the risks of AI convergence with biotechnologies.
U.S. civilian and military agencies should invest in an ambitious research agenda to assess the dual-use risks posed by AI-enabled bio design tools, consider what steps will effectively prevent large language models (LLMs) from lowering knowledge barriers to the misuse of biology, monitor ongoing developments in AI-enabled automation of life sciences research, and establish preemptive guardrails to protect data and advance norms and standards for these technologies. This research should be done on an ongoing basis to keep pace with technological advances and identify emerging risks.
Many of these research priorities are articulated in the new White House executive order on AI, which initiates several reviews on both how AI could increase biosecurity risks and how it could benefit biological discovery and public health. The order directs a variety of agencies and departments to develop guidance and benchmarks for auditing future AI capabilities, including red-teaming and evaluating dual-use models, and for protecting U.S. government biological data, elevating responsibility for implementation to a new cabinet-level White House AI council. It also eases the pathways for AI professionals to join the federal government, which will be critical to ensure that agencies have the staff capacity to monitor advancing capabilities and, when needed, institute new guidance, safeguards, and regulations in an agile way. The executive order recognizes the international nature of these threats and commits the United States to working with other nations to ensure technologies are safe, secure, trustworthy, and interoperable. Partner nations echoed these collaborative intentions at the 2023 AI Safety Summit in the United Kingdom, in the resulting Bletchley Declaration, and in related efforts by the G7 and the United Nations.
The U.S. government should make clear it will work only with LLM developers who are dedicated to producing safe and secure models — for instance, those who agreed to voluntary commitments with the White House earlier in 2023. It should also support efforts within the science community to establish and implement principles to guide responsible use of AI technologies in biomolecular design.
Action 8: Research and update basic laboratory protections, including fit-for-purpose PPE and workforce training.
The U.S. government should invest in research and demonstration pilots focused on innovative, fit-for-purpose PPE that is better adapted to the diverse healthcare workforce. Actions should include encouraging the uptake of reusable PPE, which has been shown to lower infection rates and increase productivity; adapting the standard for health worker PPE to follow designs for women; creating designs that accommodate religious headwear, beards, and the faces of people of color; and providing workforce training. There should also be a focus on ensuring a warm manufacturing base, options for rapid expansion of domestic production and distribution in the event of an emergency, and improved monitoring of logistics chains of raw materials.
In the United States, organizations that engage in research on potential pandemic pathogens should have established relationships with regional or national medical centers equipped to provide full-spectrum diagnostic and treatment capabilities and biocontainment in the event of accidental pathogen exposure. This would be a critical step outside the lab to prevent further community spread. Regional relationships could be established through the National Emerging Special Pathogens Training and Education Center.
A Moment of Opportunity
In the post-Covid moment, the eight commonsense actions proposed by the CSIS bipartisan alliance lay out a realistic vision for achieving concerted progress in reducing the risks of biological accidents and misuse of dangerous biological agents while providing a safe path for continued research on naturally occurring infectious disease threats. These eminently pragmatic steps are affordable and need not be unduly burdensome, and they will enhance the protection of Americans and others who are vulnerable today. But that protection will only be realized with sufficient political will and a sustained commitment to building adequate staff and programs. An expedited costing exercise is an important next step.
These eminently pragmatic steps are affordable and need not be unduly burdensome, and they will enhance the protection of Americans and others who are vulnerable today.
At their core, these commonsense actions will address two vexing gaps. They will clarify who at the White House is mandated to set national policy and ensure authoritative leadership, including effective coordination and oversight across the government and with partners outside government. They will also enhance the U.S. government’s capability to implement policies in the many diverse departments and agencies that require stronger biosafety and biosecurity approaches.
If carried forward, this package of actions could win support from diverse political perspectives and different institutional interests, deliver results that stir momentum, and open a pathway to U.S. leadership at home and abroad in creating a far safer and more predictable bioeconomy.
J. Stephen Morrison is a senior vice president at the Center for Strategic and International Studies (CSIS) and directs its Global Health Policy Center. Through several high-level commissions, he has shaped decisions in Congress and the administration on HIV/AIDS, reproductive health and gender equality, and health security, including pandemic preparedness. Currently, the CSIS Bipartisan Alliance for Global Health Security is addressing critical post-Covid challenges.
Michaela Simoneau is an associate fellow for global health security with the Global Health Policy Center at CSIS. She manages the secretariat of the CSIS Bipartisan Alliance for Global Health Security and formerly managed the secretariat of the CSIS Commission on Strengthening America’s Health Security, both groups of senior experts charged with generating bipartisan recommendations to strengthen U.S. and global pandemic preparedness and response policy.