Advancing the U.S. leadership in emerging biotechnology is a strategic imperative, one that will shape regional development within the U.S., economic competitiveness abroad, and our national security for decades to come. In the past few years, the contribution of biotechnology to the U.S. economy (referred to as the bioeconomy) has grown significantly, contributing over $210 billion to GDP and creating more than 640,000 domestic jobs, cementing its role as a major and expanding economic force. The impact of biotechnologies and biomanufacturing can be seen across diverse sectors and geographies, with applications spanning agriculture, energy, industrial manufacturing, and health. As biotechnology continues to drive innovation, it is emerging as a core engine of the next industrial revolution. 

To maximize the strategic potential of emerging biotechnology, Congress established the bipartisan National Security Commission on Emerging Biotechnology (NSCEB) through the FY22 National Defense Authorization Act. The commission was tasked with conducting a comprehensive review of how advancements in biotechnology and related technologies will shape the current and future missions of the Department of Defense (DOD), and developing actionable policy recommendations to support the adoption and advancement of biotechnology within DOD and across the federal government. This effort culminated in a report, “Charting the Future of Biotechnology”, delivered to Congress in April 2025. The final report outlines 49 recommendations aimed at accelerating biotechnology innovation and scaling the U.S. biomanufacturing base, reinforcing the bioeconomy as a strategic pillar of national security and economic competitiveness. 

In addition to developing a series of recommendations to promote and grow the U.S. bioeconomy, the Commission has also been tasked with facilitating the implementation and adoption of these policy recommendations by Congress and relevant federal agencies. To date, several pieces of legislation have been introduced in both the 118th and 119th Congress that incorporate recommendations from NSCEB’s interim and final reports (Table 1). This Legislation Tracker will be updated as this legislation moves through the process and as new bills are introduced.

Table 1: Legislation Tracker

The NSCEB report represents a critical policy opportunity for the U.S. bioeconomy. It proposes an injection of $15 billion to support sustained growth in biotechnology innovation and biomanufacturing through strategic investment and improved coordination. This level of investment is significant and would signal congressional support for the bioeconomy that goes beyond that seen in CHIPS and Science Act and the Inflation Reduction Act of 2022. This much needed infusion of federal investment offers a timely opportunity to build on existing momentum and unlock the next phase of U.S. leadership in the bioeconomy. 

The recommendations in the report should be seen as opportunities for engagement with the Commission and with Congress for further refinement of these policy ideas. As the Commission begins its work on implementation, they have called on stakeholders across the bioeconomy to help refine and strengthen its proposals. Responding to this need, the Federation of American Scientists (FAS) has identified priority areas requiring greater clarity and has issued an open call for supplemental recommendations and policy proposals through the Day One Open Call process.

Overall, FAS supports the Commission’s final report and we applaud the Commission’s efforts to elevate the national conversation around emerging biotechnologies. The report provides a necessary foundation for long-term federal strategy and investment in biotechnology and biomanufacturing. At the same time, there remain clear opportunities to strengthen the recommendations through greater specificity and deeper stakeholder engagement. Two overarching decisions by the Commission deserve some additional scrutiny. First, the report’s adversarial framing towards China, while grounded in strategic reality, risks overlooking opportunities for targeted collaboration that could yield global benefits, particularly in areas where scientific progress depends on multinational cooperation. Second, the final report gives limited attention to the agricultural sector, despite its clear relevance to national security and the DOD’s growing interest in agricultural biotechnology. The “Additional Considerations” section does include a constructive call to modernize the USDA’s BioPreferred Program and update federal classification systems, recommendations that echo those issued by FAS. A more comprehensive approach toward this sector is needed.

The following sections summarize the report’s key pillars and provide analysis, highlighting core recommendations and identifying opportunities where additional detail and stakeholder input, through the Day One Open Call, will be essential for translating the report’s vision into actionable, high-impact policy. Additionally, the Supplementary Recommendations Table for the NSCEB Final Report (Table 2) lists each of the recommendations from the pillars and cross references related proposals from prior FAS work, subject matter experts, and Day One Memos submitted by external stakeholders.

Table 2: Supplementary Recommendations Table for the NSCEB Final Report

Pillar 1. Prioritize Biotechnology at the National Level

Pillar 1 of the report emphasizes the need to prioritize biotechnology at the national level. The recommendations within this pillar are essential for the development of a cohesive national strategy, and we encourage Congress to consider incorporating terminology and drawing on previous policy related to the bioeconomy to ensure that previous progress related to emerging biotechnologies is not lost.

A central recommendation within this Pillar is the establishment of the National Biotechnology Coordination Office (NBCO), which would reduce fragmentation and elevate biotechnology as a national priority. To succeed, the NBCO must address challenges faced by past coordination bodies and be empowered by the administration to drive cross-agency strategy despite differing institutional perspectives. While the presidential appointment of the director could lend authority, it also risks politicization and strategic shifts that may destabilize the sector. Success will depend on clarity of roles, coordination across functions, and strong institutional support for implementation. 

FAS provided several additional recommendations and insights on these topics (see Table 2) to make them more nuanced and actionable by Congress, including: 

• Coordinating the U.S. Government Approach to the Bioeconomy by Sarah Carter
• A National Bioeconomy Manufacturing and Innovation Initiative by Alexander Titus

Pillar 2. Mobilize the Private Sector to get U.S. Products to Scale

Pillar 2 of the final report focuses on mobilizing the private sector to strengthen biotechnology products by addressing key challenges to the sector, including regulatory reform, financing obstacles, and infrastructure and data needs. While the report correctly identifies long standing regulatory bottlenecks for products of biotechnology under the Coordinated Framework, including unclear oversight and interagency conflicts, it also acknowledges statutory complexities that make reform difficult. Empowering the Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA) to mediate these disputes is a promising approach, but would require statutory reinforcement. Similarly, proposals to modernize regulatory capacity, such as agency fellowships and regulatory science programs, highlight a critical need for technical expertise within government, though questions remain about institutional placement and long-term sustainability.

On financing and infrastructure, the report points to real gaps in early-stage capital and scale-up capacity, particularly for bridging the “Valley of Death” for biotechnology manufacturing. Concepts like advance market commitments and a new investment fund have potential, but their impact will depend heavily on design, risk management, and alignment with existing capital pipelines. The infrastructure recommendations are strong, but coordination challenges, particularly among national labs, regional hubs, and entities like BioMADE, must be addressed to avoid duplication or underutilization and approaches to securing bioeconomy infrastructure and data are underdeveloped. It will be critical to better define what constitutes critical biotechnology infrastructure and how it should be protected.

FAS provided significant expertise on these topics (see Table 2), such as: 

• Coordinating the U.S. Government Approach to the Bioeconomy by Sarah Carter
• Regulations for the Bioeconomy by Sarah Carter
• A National Frontier Tech Public-Private Partnership to Spur Economic Growth by Katie Rae, Orin Hoffman & Michael Kearney
• De-Risking the U.S. Bioeconomy by Establishing Financial Mechanisms to Drive Growth and Innovation by Nazish Jeffery & Zak Weston
• Advancing the U.S. Bioindustrial Production Sector by Michael Fisher
• Closing Critical Gaps from Lab to Market by Phil Weilerstein, Shaheen Mamawala, and Heath Naquin
• Strengthening the U.S. Biomanufacturing Sector Through Standardization by Chris Stowers
• Summary Report – December 7, 2022, Bioeconomy Policy Workshop: Financial and Economic Tools
• Project BOoST: A Biomanufacturing Test Facility Network for Bioprocess Optimization, Scaling, and Training by Ed Charles & Chris Fracchia

One of the NSCEB’s recommendations in particular would benefit from additional input from external subject matter experts to make it more concrete and actionable for Congress:

1. Recommendation 2.2d: Congress should improve the effectiveness and reach of the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs to support early-stage innovation. Specifically, stakeholder input on:
   1. Which areas of biotechnology or sectors within the bioeconomy would most benefit from SBIR and STTR investment?
   2. How can these programs better support not only early- but also late-stage innovation?

If you have specific policy suggestions related to this topic, we encourage you to submit your ideas through the Day One Open Call page at FAS.

Pillar 3. Maximize the Benefits of Biotechnology for Defense

Pillar 3 of the final report focuses on maximizing the benefits of biotechnology for national defense, with an emphasis on the intelligence community and the Department of Defense (DOD). This pillar includes recommendations related to BioMADE oversight as well as internal workforce education on biotechnology. While oversight of BioMADE is important, it is unclear why additional oversight from Congress is needed for this manufacturing institute above and beyond that provided by its federal sponsor. Additionally, it will be essential for DOD to establish a mechanism for regularly updating workforce education in biotechnology, given the sector’s rapid and continuous evolution.

More broadly, this Pillar appropriately reframes biotechnology as a strategic capability, beyond its traditional role in R&D. This shift in perspective is timely, but realizing the potential of these technologies will require significant institutional change. Ethical use frameworks, particularly around dual-use risks (warfighter enhancement, surveillance, and environmental impact) must be developed through a transparent process that extends beyond DOD to include external stakeholders and independent organizations. In addition, proposed investment and export controls aimed at limiting adversarial advantage must be carefully scoped and implemented. The Department of Commerce (DOC) has published multiple Requests for Information (2018, 2020) to understand and delineate “high-risk” biotech products. Yet, DOC has not added new biotech products to the export list, which highlights the complexity of this task, and underscores the need for precision to avoid stifling beneficial collaboration or disrupting global supply chains.

FAS provided several additional recommendations and insights on these topics (see Table 2) to make them more nuanced and actionable by Congress, including:

• CLimate Improvements through Modern Biotechnology (CLIMB) — A National Center for Bioengineering Solutions to Climate Change and Environmental Challenges by Jennifer Panlilio & Hanny Rivera
• A Foundational Technology Development and Deployment Office to Create Jobs by Katie Rae, Michael Kearney, and Orin Hoffman

Pillar 4. Out-Innovate our Strategic Competitors

Pillar 4 of the NSCEB’s report offers recommendations for strengthening the biotechnology sector to out-innovate global competitors. It focuses on building robust data ecosystems, enhancing biosecurity, and expanding bio R&D infrastructure within the U.S. A central theme is the creation of a modern biological data ecosystem, which would provide the foundational infrastructure necessary to accelerate innovation. While a biological data ecosystem and associated standards are timely, several technical and governance challenges must be addressed, like harmonizing legacy systems, defining AI-readiness, and coordinating cloud lab integration. These complexities present an opportunity for stakeholder engagement and thoughtful design.

Within the Pillar, proposals that call for expanding National Lab capabilities and funding interdisciplinary biotechnology research are directionally strong, but success will depend on interagency coordination and alignment with industry needs. Finally, the report calls for stronger governance of biosafety and biosecurity, though its assertion that past efforts have “failed” could benefit from more nuanced analysis. 

While FAS provided expertise on these topics (see Table 2), such as:

• A National Bioeconomy Manufacturing and Innovation Initiative by Alexander Titus
• Kickstarting Collaborative, AI-Ready Datasets in the Life Sciences with Government-funded Projects by Erika DeBenedictis, Ben Andrew, and Pete Kelly
• Creating a National Exposome Project by  Gurdane Bhutani, Gary  Miller, and Sandeep Patel
• Accelerating Biomanufacturing and Producing Cost-Effective Amino Acids through a Grand Challenge by Allison Berke
• Accelerating Bioindustry Through Research, Innovation, and Translation by Jon Roberts

A few of the report’s recommendations would benefit from additional stakeholder input to enhance clarity and ensure they are actionable for Congress: 

1. Recommendation 4.1c: Congress should authorize and fund the Department of Interior to create a Sequencing Public Lands Initiative to collect new data from U.S. public lands that researchers can use to drive innovation and Recommendation 4.1d: Congress should authorize the National Science Foundation to establish a network of “cloud labs,” giving researchers state-of-the-art tools to make data generation easier. Specifically, stakeholder input on:
   1. What type of data should be generated and what types of data generation or collection should be prioritized?
   2. How can we best draw on or expand existing cloud lab capabilities?

2. Recommendation 4.3b: Congress should initiate a grand research challenge focused on making biotechnology predictably engineerable. Specifically, stakeholder input on:
   1. What specific grand challenge should Congress pursue and how should it be implemented?
   2. How should the U.S. government engage the scientific community (and others) in establishing and pursuing grand challenges for biotechnology?

3. Recommendation 4.4a: Congress must direct the executive branch to advance safe, secure, and responsible biotechnology research and innovation. Specifically, stakeholder input on:
   1. The report calls for establishment of a body within the U.S. government for this purpose. What should this look like and how would it operate?

If you have specific policy suggestions related to these topics, we encourage you to submit your ideas through the Day One Open Call at FAS.

Pillar 5. Build the Biotechnology Workforce of the Future

Pillar 5 of the final report looks to the future by offering recommendations to secure and build the biotechnology workforce needed in the future. It addresses both the modernization of the federal biotech workforce and the development of the broader U.S. biotech workforce. Modernizing the federal workforce requires more than training programs. It requires coordination across HR systems, consistent standards, and better integration of biotechnology experts into national security and diplomacy. Proposals to expand Congressional science capacity are long overdue and necessary to equip lawmakers to address rapidly evolving biotechnology issues. On the national level, scaling the biomanufacturing workforce will depend on aligning credentials with industry needs and securing input from labor, academia, and employers. Expanding biotechnology education is promising, but successful implementation will require investment in teacher training and curriculum development.

While FAS contributed several recommendations to support this critical capacity-building effort (see Table 2), such as:

• Gathering Industry Perspectives on how the U.S. Government can Support the Bioeconomy by Sarah Carter
• Meeting Biology’s “Sputnik Moment”: A Plan to Position the United States as a World Leader in the Bioeconomy by Natalie Kuldell

One of the NSCEB’s recommendation would benefit from additional stakeholder input to enhance its clarity and make it more actionable for Congress:

1. Recommendation 5.2a: Congress must maximize the impact of domestic biomanufacturing workforce training programs. Specifically, stakeholder input on:
   1. How should the government approach creating competency models for biomanufacturing training and microcredentialing?
   2. Which specific areas are best suited for microcredentialing efforts?

If you have specific policy suggestions related to these topics, we encourage you to submit your ideas through the Day One Open Call at FAS.

Pillar 6. Mobilize the Collective Strengths of our Allies and Partners

Pillar 6 of the final report focuses on strengthening alliances and partnerships on the global stage to enhance the U.S. biotechnology sector. It highlights the role of the State Department (DOS) in facilitating this effort through development of foreign policy tools, strengthening global data and market infrastructure, and leading in the establishment of international standards within the sector. Elevating biotechnology within U.S. foreign policy is both timely and necessary, particularly as biotech becomes increasingly strategic in areas like health security, climate resilience, and defense. Leveraging existing tools like the International Technology Security and Innovation (ITSI) Fund could provide a solid foundation, but effective execution will require clearer interagency coordination, transparency in funding allocation, and defined metrics for impact, especially across overlapping technology domains.

Proposals to create shared data infrastructure, joint purchasing mechanisms, and international fellowships point to smart long-term strategies for building trust and interoperability with allies. Yet, success hinges on careful coordination, especially around sensitive areas like dual-use biotechnology export controls. If U.S. standards are significantly more restrictive than those of allies, it could create friction and undermine broader goals of international collaboration and leadership.

FAS provided several additional recommendations and insights on these topics (see Table 2) to make them more nuanced and actionable by Congress, including:

• A Matter of Trust: Helping the Bioeconomy Reach Its Full Potential with Translational Governance by  Christopher J. Gillespie
• Strategic Investments the U.S. Should Make in the Bioeconomy Right Now by Nazish Jeffery
• Strengthening U.S. Engagement in International Standards Bodies by Natalie Thompson and Mark Montgomery
• What’s Next for the U.S. Bioeconomy? Defining It. by Nazish Jeffery

One particularly important recommendation emphasizes the need to engage the public and build trust in the sector by collecting data on public acceptance. This data can help inform national governance and ensure it is more responsive and translatable to public concerns.

Additional Considerations

The additional considerations section of the NSCEB report brings several key recommendations that do not fit with the rest of the report, though are still very important. Many focus on aligning federal leadership and economic infrastructure with the needs of a growing and strategically vital biotechnology sector. Elevating biotechnology leadership within DOD is a logical step to align R&D with budget authority and operational needs. Similarly, expanding the scope of the Bioenergy Technologies Office (BETO) beyond biofuels and codifying the Office of Critical and Emerging Technology (OCET) role reflects an overdue shift toward recognizing biotech’s relevance to national security and broader innovation policy, though these changes will require institutional buy-in and cultural adjustment. On the economic side, proposals to create a public-private innovation consortium are timely, especially for supporting smaller firms and navigating the convergence of biotechnology with other technologies, like AI. However, care should be taken to not overly narrow the scope at the expense of other critical intersections. 

While FAS provided a few recommendations on these topics (see Table 2), such as:

• Summary Report – December 5, 2022, Bioeconomy Policy Workshop: Measurement and Language
• Laying the Groundwork for the Bioeconomy by Sarah Carter

One of the report’s recommendations would benefit from additional stakeholder input to enhance clarity and ensure that it is actionable for Congress: 

1. Recommendation 8: Congress should direct the National Science Foundation (NSF) to establish a federal grant program for a national system of community biology labs that would engage Americans in informal learning. Specifically, stakeholder input on:
   1. What is most needed to support community biology labs?
   2. Should community labs be incorporated within universities or run as independent institutions?

If you have specific policy suggestions related to these topics, we encourage you to submit your ideas through the Day One Open Call at FAS.

Next Steps for the U.S. Bioeconomy 

The NSCEB’s final report outlines a vision for a national biotechnology strategy aimed at securing U.S. leadership in a sector that is not only rapidly advancing but also delivering significant economic returns, outpacing even AI. While the report offers thoughtful, well-grounded recommendations that address many of the core challenges facing the U.S. biotechnology landscape, several proposals would benefit from greater specificity and refinement to make them actionable in legislative form. This moment presents a unique opportunity for stakeholders across the biotechnology ecosystem to contribute meaningfully to the development of a national bioeconomy strategy. 

The U.S. bioeconomy, which encompasses biotechnology, holds enormous strategic and economic potential. Without a clear, well-implemented plan, the nation risks repeating the mistakes of past industrial shifts, such as the decline in domestic semiconductor leadership. FAS urges Congress to act on the Commission’s recommendations and leverage FAS’ additional proposals to strengthen them further (see Table 2). We also call on the scientific community to provide additional input on these recommendations to ensure they are viable and impactful. If you have actionable policy ideas on how to shape the path forward for the U.S. bioeconomy, we encourage you to submit them through the Day One Open Call. Applicants with compelling ideas will be partnered with our team at FAS to develop their idea into an implementation ready policy memo. Click here to learn more about the Day One Open Call. 

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FAS Bioeconomy Open Call Areas

• Recommendation 2.2d (SBIR and STTR): Congress should improve the effectiveness and reach of the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs to support early-stage innovation.
  • Which areas of biotechnology or sectors within the bioeconomy would most benefit from SBIR and STTR investment?
  • How can these programs better support not only early- but also late-stage innovation?

• Recommendation 4.1c (Bio Data Generation): Congress should authorize and fund the Department of Interior to create a Sequencing Public Lands Initiative to collect new data from U.S. public lands that researchers can use to drive innovation and Recommendation 4.1d: Congress should authorize the National Science Foundation to establish a network of “cloud labs,” giving researchers state-of-the-art tools to make data generation easier.
  • What type of data should be generated and what types of data generation or collection should be prioritized?
  • How can we best draw on or expand existing cloud lab capabilities?

• Recommendation 4.3b (Predictable BioEngineering): Congress should initiate a grand research challenge focused on making biotechnology predictably engineerable.
  • What specific grand challenge should Congress pursue and how should it be implemented?
  • How should the U.S. government engage the scientific community (and others) in establishing and pursuing grand challenges for biotechnology?

• Recommendation 4.4a (Safe, Secure, Responsible): Congress must direct the executive branch to advance safe, secure, and responsible biotechnology research and innovation.
  • The report calls for establishment of a body within the U.S. government for this purpose. What should this look like and how would it operate?

• Recommendation 5.2a (Domestic Bio Workforce): Congress must maximize the impact of domestic biomanufacturing workforce training programs.
  • How should the government approach creating competency models for biomanufacturing training and microcredentialing?
  • Which specific areas are best suited for microcredentialing efforts?

• Additional Considerations #8 (Grant Programs): Congress should direct the National Science Foundation (NSF) to establish a federal grant program for a national system of community biology labs that would engage Americans in informal learning.
  • What is most needed to support community biology labs?
  • Should community labs be incorporated within universities or run as independent institutions?

The Federation of American Scientists supports the National Security Commission on Emerging Biotechnology’s Final Report and the Recommendations contained within it.

Charting the Future of Biotechnology delivers 49 recommendations to foster the growth of the biotechnology and biomanufacturing sector within the U.S. bioeconomy. Implementing the recommendations outlined in this report will strengthen the U.S. bioeconomy by establishing a unified national strategy that fosters innovation in biotechnology, ensures our continued global competitiveness, and delivers significant economic and societal benefits to the nation.

FAS is particularly excited by these recommendations:

• 1.1a: Establishment of a National Biotechnology Coordination Office
• 2.2a-d: Economic levers to promote scale-up and innovations coming to market
• 2.4a: Biotechnology infrastructure and data to be classified as “critical infrastructure”
• 3.1a: Department of Defense to consult with stakeholders to define principles for ethical use of biotechnology
• 4.3a-c: Centers for Biotechnology
• 5.1a through 5.3b: Biotechnology workforce for the future
• 6.1a-e: Strengthen global U.S. biotechnology efforts through global policy 

These recommendations have the potential to address key challenges within the U.S. bioeconomy, including the lack of a coordinated strategy, commercialization barriers, workforce shortages, and supply chain vulnerabilities.

“FAS applauds the NSCEB’s deep investigation of unlocking U.S.-led biotechnology in the Fourth Industrial Revolution. We look forward to bringing FAS’s unique and effective approach of policy entrepreneurship to realize the promise of these capabilities while reducing the risks of misuse,” said Yong-Bee Lim, Associate Director of Global Risk at the Federation of American Scientists.

“The National Commission on Emerging Biotechnology report developed 50 recommendations to address the major challenges currently facing the U.S. bioeconomy: a lack of strategy and coordination across the federal government, difficulties in scaling biotechnology innovations, and the need for a trained workforce for the future. These recommendations aim to de-risk the biotechnology sector, thereby enabling private sector investment in critical biotechnology and biomanufacturing initiatives. Ultimately, these efforts will foster continued growth, secure the U.S. bioeconomy, and lead to the creation of new jobs and further economic growth.”” said Nazish Jeffery, Bioeconomy Policy Manager at the Federation of American Scientists. “It will be important to continue advocating, refining, and adding additional recommendations in order to realize the full value that this report offers.”

For more information contact Nazish Jeffery, FAS Bioeconomy Policy Manager, njeffery@fas.org.

Grant Funds Research of AI’s Impact on Nuclear Weapons, Biosecurity, Military Autonomy, Cyber, and other global issues

Washington, D.C. – September 11, 2024 – The Federation of American Scientists (FAS) has received a $1.5 million grant from the Future of Life Institute (FLI) to investigate the implications of artificial intelligence on global risk. The 18-month project supports FAS’s efforts to bring together the world’s leading security and technology experts to better understand and inform policy on the nexus between AI and several global issues, including nuclear deterrence and security, bioengineering, autonomy and lethality, and cyber security-related issues.

FAS’s CEO Daniel Correa noted that “understanding and responding to how new technology will change the world is why the Federation of American Scientists was founded. Against this backdrop, FAS has embarked on a critical journey to explore AI’s potential. Our goal is not just to understand these risks, but to ensure that as AI technology advances, humanity’s ability to understand and manage the potential of this technology advances as well.

“When the inventors of the atomic bomb looked at the world they helped create, they understood that without scientific expertise and brought her perspectives humanity would never live the potential benefits they had helped bring about. They founded FAS to ensure the voice of objective science was at the policy table, and we remain committed to that effort after almost 80 years.”

“We’re excited to partner with FLI on this essential work,” said Jon Wolfsthal, who directs FAS’ Global Risk Program.  “AI is changing the world. Understanding this technology and how humans interact with it will affect the pressing global issues that will determine the fate of all humanity. Our work will help policy makers better understand these complex relationships. No one fully understands what AI will do for us or to us, but having all perspectives in the room and working to protect against negative outcomes and maximizing positive ones is how good policy starts.”

“As the power of AI systems continues to grow unchecked, so too does the risk of devastating misuse and accidents,” writes FLI President Max Tegmark. “Understanding the evolution of different global threats in the context of AI’s dizzying development is instrumental to our continued security, and we are honored to support FAS in this vital work.”

The project will include a series of activities, including high-level focused workshops with world-leading experts and officials on different aspects of artificial intelligence and global risk, policy sprints and fellows, and directed research, and conclude with a global summit on global risk and AI in Washington in 2026.

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ABOUT FAS

The Federation of American Scientists (FAS) works to advance progress on a broad suite of contemporary issues where science, technology, and innovation policy can deliver dramatic progress, and seeks to ensure that scientific and technical expertise have a seat at the policymaking table. Established in 1945 by scientists in response to the atomic bomb, FAS continues to work on behalf of a safer, more equitable, and more peaceful world. More information at fas.org.

ABOUT FLI

Founded in 2014, the Future of Life Institute (FLI) is a leading nonprofit working to steer transformative technology towards benefiting humanity. FLI is best known for their 2023 open letter calling for a six-month pause on advanced AI development, endorsed by experts such as Yoshua Bengio and Stuart Russell, as well as their work on the Asilomar AI Principles and recent EU AI Act.

The Biological Weapons Convention’s Ninth Review Conference (RevCon) took place under a unique geopolitical storm, as the COVID-19 pandemic raged and the Russian invasion of Ukraine took center stage. Russia’s continued claims of United States-sponsored bioweapons research laboratories in Ukraine only added to the tension. Russia asserted that they had uncovered evidence of offensive biological weapons research underway in Ukrainian labs, supported by the United States, and that the invasion of Ukraine was due to the threat they faced so close to their borders. 

While this story has been repeated countless times to countless audiences – including an Article V consultative meeting and the United Nations Security Council (UNSC) as part of an Article VI complaint against the U.S. lodged by Russia, the fact remains that Russia’s assertion is untrue.

The biological laboratories present in Ukraine operate as part of the Department of Defense’s Biological Threat Reduction Program, and are run by Ukrainian scientists charged with detecting and responding to emerging pathogens in the area. Articles V and VI of the Biological Weapons Convention (BWC) are intended to be invoked when a State Party hopes to resolve a problem of cooperation or report a breach of the Convention, respectively. The Article V formal consultative meeting resulted in no consensus being reached, and the Article VI UNSC meeting rejected Russia’s claims. The lack of consensus during the consultative meeting created a foothold for Russia to continue their campaign of disinformation, and the UNSC meeting only further reinforced it. The Article V and VI clauses are meant to provide some means of mediation and recourse to States Parties in the case of BWC violation. However, in this case they were not invoked in good faith, rather, they were used as a springboard for a sweeping Russian disinformation campaign.

Abusing Behavioral Norms for Political Gain

While Russia’s initial steps of calling for an Article V consultative meeting and an Article VI Security Council investigation do not seem outwardly untoward, Russia’s behavior during and after these proceedings dismissed the claims indicated their deeper purpose. 

Example: Misdirection in Documentation Review

During the RevCon, the Russian delegation often brought up how the results of the UNSC investigation would be described in the final document during the article-by-article review, calling for versions of the document that included more slanted versions of the events. They also continually mentioned the U.S.’ refusal to answer their questions, despite the answers being publicly available on the consultative meeting’s UNODA page, the Russians characterized their repeated mentioning of the UNSC investigation findings as an act of defiant heroism, implying that the U.S. was trying to quash their valid concerns, but that Russia would continue to raise them until the world had gotten the answers it deserved. This narrative directly contradicts the facts of the Article V and VI proceedings. The UNSC saw no need to continue investigating Russia’s claims. 

Example: Side Programming with Questionable Intent 

The Russian delegation also conducted a side event during the BWC dedicated to the outcomes of the consultative meeting. The side event included a short ‘documentary’ of Russian evidence that the U.S.-Ukraine laboratories were conducting biological weapons research. This evidence included footage of pesticide-dispersal drones in a parking lot that were supposedly modified to hold bioweapons canisters, cardboard boxes with USAID stickers on them, and a list of pathogen samples supposedly present that were destroyed prior to filming. When asked about next steps, the Russian delegation made thinly veiled threats to hold larger BWC negotiations hostage, stating that if the U.S. and its allies maintain their position and don’t demonstrate any further interest in continuing dialogue, it would be difficult for the 9^th RevCon to reach consensus. 

Example: Misuse of ‘Point of Order’

Russia’s behavior at the 9^th RevCon emphasizes the unwitting role international institutions can play as springboards for state-sponsored propaganda and disinformation. 

During opening statements, the Russian delegation continually called a point of order upon any mention of the Russian invasion of Ukraine. A point of order allows the delegation to respond to the speaker immediately, effectively interrupting their statement. During the Ukrainian delegation’s opening statement, the Russian delegation called four points of order, citing Ukraine’s “political statements” as disconnected from the BWC discussion. Russia’s use of the rules of procedure to bully other delegations continued – after they concluded a point of order during the NATO delegate’s statement, they called another one almost immediately after the NATO delegate resumed her statement with the singular word, “Russia.” This behavior continued throughout all three weeks of the RevCon. 

Example: Single Vote Disruption Made in Bad Faith

All BWC votes are adopted by consensus, meaning that all states parties have to agree for a decision to be made. While this helps ensure the greatest inclusivity and equality between states parties, as well as promote implementation, it also means that one country can be the ‘spoiler’ and disrupt even widely supported changes. 

For example, in 2001, the United States pulled out of verification mechanism negotiations at the last minute, upending the entire effort. Russia’s behavior in 2022 was similarly disruptive, but made with the goal of subversion. The vote changed how other delegations reacted, as representatives seemed more reluctant to mention the Article V and VI proceedings. The structure of the United Nations as impartial and the BWC as consensus-based means that by their very nature they cannot combat their misuse. Any progress to be had by the BWC relies on states operating in good faith, which is impossible to do when a country has a disinformation agenda.

Thus, the very nature of the UN and associated bodies attenuates their ability to respond to states’ misuse. Russia’s behavior at the 9th RevCon is part of a pattern that shows no signs of slowing down. 

We Need More Sophisticated Biological Verification and Attribution Tools

The actions described above demonstrate the door has been kicked fully open for regimes to use the UN and associated bodies as mouthpieces for state-sponsored propaganda. 

So, it is imperative that 1) more sophisticated biological verification and attribution tools be developed, and 2) the BWC implements a legally binding verification mechanism. 

The development of better verification methods to verify whether biological research is for civil or military purposes will help to remove ambiguity around laboratory activities around the world. It will also make it harder for benign activities to be misidentified as offensive biological weapons activities. 

Further, improved attribution methods will  determine where biological weapons originate from and will further remove ambiguity during a genuine biological attack. 

The development of both these capabilities will strengthen an eventual legally binding verification mechanism. These two changes will also allow Article V consultative meetings and Article VI UNSC meetings to determine the presence of offensive bioweapons research more definitively, thus contributing rather substantively to the strengthening of the convention. As ambiguity around the results of these investigations decreases, so does the space for disinformation to take hold.

It’s no secret that the world is becoming increasingly complex and interconnected. And as our societies become more technologically advanced, the risks of a global catastrophe become greater. Natural disasters or severe climate change in one part of the world can quickly become a humanitarian crisis in another, an airborne virus can spread around the globe in days, and a terrorist attack can have ripple effects across borders. In recent years, we’ve seen a number of such major disasters—both natural and man-made—that have had devastating impacts on communities around the world. From hurricanes and earthquakes to cyberattacks and pandemics, these events have shown us just how vulnerable we are to the forces of nature and the dangers posed by our own technologies. Yet, despite the clear and present danger, governments appear woefully unprepared to manage any of these risks.

Fortunately, top lawmakers on the Senate Homeland Security and Government Affairs Committee (HSGAC), Senator Rob Portman (R-OH) and Senator Gary Peters (D-MI), have introduced legislation—the Global Catastrophic Risk Preparedness Act—that would establish an interagency taskforce to study how the U.S. government should be prepared to mitigate and manage such risks. This bipartisan legislation would ensure that our government has the tools and resources necessary to identify, assess, and respond to these risks in a coordinated and effective manner and would be the first critical step towards a national preparedness plan. 

In recent years, the U.S. government has been caught flat-footed by a number of global catastrophic risks. From pandemics to climate change, the U.S. has been slow to respond to these existential threats. While the probability of some of these events happening may be low, the potential consequences are far too severe to ignore.

Given the potentially devastating consequences of these events, it is essential that the U.S. government is prepared to manage them should they occur. Moreover, the cost of preparing for them is dwarfed by the cost of doing nothing and being caught unprepared when one of them does occur. For instance, the COVID-19 pandemic has cost the United States over $16 trillion, while the White House estimates it needs merely $65 billion to help prevent the next pandemic. Similarly, an analysis by Deloitte found that if the U.S. does not decarbonize over the next 50 years, it would cost the economy nearly $14.5 trillion but the U.S. economy would gain $3 trillion if it rapidly decarbonizes during that time. But to prevent such catastrophic events from happening requires an all-of-government approach to mitigation and preparedness—a gap this legislation aims to fill.

Aside from the natural catastrophes waiting to happen in the lack of a coordinated global response, there are also man-made catastrophic risks that the U.S. Government must be prepared to mitigate and manage. In 1939, Einstein wrote to President Roosevelt, warning him of the possibility to engineer a nuclear chain reaction that could lead to the creation of powerful bombs. Just a few years later, these bombs were created. In little more than a decade, enough had been produced that, for the first time in history, a handful of decision-makers could destroy civilization. Humanity had entered a new age, in which we faced not only existential risks from our natural environment, but also the possibility that we might be able to extinguish ourselves. This technology which was considered “emerging” in 1939 almost led to destruction of humanity 23 years later.

It is difficult to forecast what emerging technologies may develop in the future. Emerging technologies are quite literally emerging. When they are realized, they develop rapidly and the full extent of their capabilities is often not known for years or even decades. Just last year, The Department of Justice indicted several FSB officers for their involvement in a multi-stage campaign in which they gained remote access to critical infrastructure, including a US nuclear power plant where they planted malware. In 2005, Paul Krugman would have likely laughed at the possibility of the internet being used as a weapon to cause a nuclear meltdown. Yet to come machine learning technologies in possession of power hungry dictators could potentially be used in a similar manner to expand their powers and harm large populations in other countries. An algorithm that can identify a cure for superbugs could also be used by bioterrorists to find strains of viruses that likely evade any such cures. Thus preparing for what could potentially happen, even if considered a low probability event today, only makes sense.

While lawmakers fuss over the finer details of the Global Catastrophic Risk Preparedness Act, it is also essential to look at the next steps. If an interagency task force works to develop an assessment of the current state of preparedness and implementation plans to prepare the U.S. government for these risks, it would also be responsible for ensuring that these plans are regularly updated and tested, so that we can be as prepared as possible when—not if, as we see with climate change—one of these events happens. Some may argue that this is unnecessary bureaucracy—but given the stakes involved, we cannot afford to take chances. The time to act is now, before it’s too late.

WASHINGTON, D.C. — The Federation of American Scientists joined over 30 leaders in the scientific, medical, public health, research, and science policy fields in providing a set of recommendations regarding oversight of enhanced potential pandemic pathogen (ePPP) research and dual use research to the National Science Advisory Board on Biosecurity (NSABB). Research involving potential pandemic pathogens can provide significant benefits to society but, if done incorrectly, can also contribute to pandemic risk.

The recommendations aim to diminish the risk that U.S. science could inadvertently initiate epidemics or pandemics, clarify the scope and decision-making process associated with governance of ePPP research and dual-use science, increase transparency around U.S. policy and decision making on these issues, and minimize or eliminate disruption of science work that does not pose these risks.

“Without proper governance, dual use research can be as dangerous as it is illuminating. The U.S. government must revise its decision-making process to protect scientists and the public,” said FAS CEO Daniel Correa. “Bio innovation and pandemic prevention are not disparate aims, and finding the balance between them can enhance pathogen research responsibly and foster innovation.”

The letter highlights five primary recommendations to improve the guidance and implementation of governing research related to dual use and ePPP pathogens including:

• Modify and expand the scope of pathogens governed by the ePPP Framework to include criterion of research that could lead to another pandemic not currently accounted for in the framework – including modest virulence, enhanced virulence and transmissibility regardless of the starting pathogen, and oversight of sequencing viruses.
• Assess and detail risks and benefits to provide guidance on when benefits of research would outweigh the risks, including detailed risk and benefit factors.
• Clarify and restructure processes of review, communication, biosafety and biosecurity, and transparency to include involvement of more stakeholders, preventing conflicts of interest, and overall more transparent standards and guidelines.
• Expand the reach of the ePPP Framework to apply to non-federally funded research and be implemented by all U.S. government agencies, as well as to strengthen international outreach.
• Revise the policy for dual use research of concern (DURC) to include additional pathogens, types of experiments, and clarify risk assessment and mitigation plan requirements.

Read the full letter to the NSABB here.

2022 Bioautomation Challenge: Investing in Automating Protein Engineering
Thomas Kalil, Chief Innovation Officer of Schmidt Futures, interviews biomedical engineer Erika DeBenedictis

Schmidt Futures is supporting an initiative – the 2022 Bioautomation Challenge – to accelerate the adoption of automation by leading researchers in protein engineering. The Federation of American Scientists will act as the fiscal sponsor for this challenge.

​This initiative was designed by Erika DeBenedictis, who will also serve as the program director. Erika holds a PhD in biological engineering from MIT, and has also worked in biochemist David Baker’s lab on machine learning for protein design ​​at the University of Washington in Seattle.  

​Recently, I caught up with Erika to understand why she’s excited about the opportunity to automate protein engineering.

Why is it important to encourage widespread use of automation in life science research?

Automation improves reproducibility and scalability of life science. Today, it is difficult to transfer experiments between labs. This slows progress in the entire field, both amongst academics and also from academia to industry. Automation allows new techniques to be shared frictionlessly, accelerating broader availability of new techniques. It also allows us to make better use of our scientific workforce. Widespread automation in life science would shift the time spent away from repetitive experiments and toward more creative, conceptual work, including designing experiments and carefully selecting the most important problems. 

How did you get interested in the role that automation can play in the life sciences?

​I started graduate school in biological engineering directly after working as a software engineer at Dropbox. I was shocked to learn that people use a drag-and-drop GUI to control laboratory automation rather than an actual programming language. It was clear to me that automation has the potential to massively accelerate life science research, and there’s a lot of low-hanging fruit. 

Why is this the right time to encourage the adoption of automation?

​The industrial revolution was 200 years ago, and yet people are still using hand pipettes. It’s insane! The hardware for doing life science robotically is quite mature at this point, and there are quite a few groups (Ginkgo, Strateos, Emerald Cloud Lab, Arctoris) that have automated robotic setups. Two barriers to widespread automation remain: the development of robust protocols that are well adapted to robotic execution and overcoming cultural and institutional inertia.

What role could automation play in generating the data we need for machine learning?  What are the limitations of today’s publicly available data sets?

​There’s plenty of life science datasets available online, but unfortunately most of it is unusable for machine learning purposes. Datasets collected by individual labs are usually too small, and combining datasets between labs, or even amongst different experimentalists, is often a nightmare. Today, when two different people run the ‘same’ experiment they will often get subtly different results. That’s a problem we need to systematically fix before we can collect big datasets. Automating and standardizing measurements is one promising strategy to address this challenge.

Why protein engineering?

​The success of AlphaFold has highlighted to everyone the value of using machine learning to understand molecular biology. Methods for machine-learning guided closed-loop protein engineering are increasingly well developed, and automation makes it that much easier for scientists to benefit from these techniques. Protein engineering also benefits from “robotic brute force.” When you engineer any protein, it is always valuable to test more variants, making this discipline uniquely benefit from automation. 

If it’s such a good idea, why haven’t academics done it in the past?

​Cost and risk are the main barriers. What sort of methods are valuable to automate and run remotely? Will automation be as valuable as expected? It’s a totally different research paradigm; what will it be like? Even assuming that an academic wants to go ahead and spend $300k for a year of access to a cloud laboratory, it is difficult to find a funding source. Very few labs have enough discretionary funds to cover this cost, equipment grants are unlikely to pay for cloud lab access, and it is not obvious whether or not the NIH or other traditional funders would look favorably on this sort of expense in the budget for an R01 or equivalent. Additionally, it is difficult to seek out funding without already having data demonstrating the utility of automation for a particular application. All together, there are just a lot of barriers to entry.

You’re starting this new program called the 2022 Bioautomation Challenge. How does the program eliminate those barriers?

​This program is designed to allow academic labs to test out automation with little risk and at no cost. Groups are invited to submit proposals for methods they would like to automate. Selected proposals will be granted three months of cloud lab development time, plus a generous reagent budget. Groups that successfully automate their method will also be given transition funding so that they can continue to use their cloud lab method while applying for grants with their brand-new preliminary data. This way, labs don’t need to put in any money up-front, and are able to decide whether they like the workflow and results of automation before finding long-term funding.

Historically, some investments that have been made in automation have been disappointing, like GM in the 1980s, or Tesla in the 2010s. What can we learn from the experiences of other industries? Are there any risks?

​For sure. I would say even “life science in the 2010s” is an example of disappointing automation: academic labs started buying automation robots, but it didn’t end up being the right paradigm to see the benefits. I see the 2022 Bioautomation Challenge as an experiment itself: we’re going to empower labs across the country to test out many different use cases for cloud labs to see what works and what doesn’t.

Where will funding for cloud lab access come from in the future?

​Currently there’s a question as to whether traditional funding sources like the NIH would look favorably on cloud lab access in a budget. One of the goals of this program is to demonstrate the benefits of cloud science, which I hope will encourage traditional funders to support this research paradigm. In addition, the natural place to house cloud lab access in the academic ecosystem is at the university level. I expect that many universities may create cloud lab access programs, or upgrade their existing core facilities into cloud labs. In fact, it’s already happening: Carnegie Mellon recently announced they’re opening a local robotic facility that runs Emerald Cloud Lab’s software.

What role will biofabs and core facilities play?

​In 10 years, I think the terms “biofab,” “core facility,” and “cloud lab” will all be synonymous. Today the only important difference is how experiments are specified: many core facilities still take orders through bespoke Google forms, whereas Emerald Cloud Lab has figured out how to expose a single programming interface for all their instruments. We’re implementing this program at Emerald because it’s important that all the labs that participate can talk to one another and share protocols, rather than each developing methods that can only run in their local biofab. Eventually, I think we’ll see standardization, and all the facilities will be capable of running any protocol for which they have the necessary instruments.

In addition to protein engineering, are there other areas in the life sciences that would benefit from cloud labs and large-scale, reliable data collection for machine learning?

​I think there are many areas that would benefit. Areas that struggle with reproducibility, are manually repetitive and time intensive, or that benefit from closely integrating computational analysis with data are both good targets for automation. Microscopy and mammalian tissue culture might be another two candidates. But there’s a lot of intellectual work for the community to do in order to articulate problems that can be solved with machine learning approaches, if given the opportunity to collect the data.

In this report, Christoper Bidwell, JD and Randall Murch, PhD, explore the use of microbial forensics as a tool for creating a common base line for understanding biologically-triggered phenomena, as well as one that can promote mutual cooperation in addressing these phenomena. A particular focus is given to the Middle East/North Africa (MENA) region, as it has been forced to deal with multiple instances of both naturally-occurring and man-made biological threats over the last 10 years. Although the institution of a microbial forensics capability in the MENA region (however robust) is still several years away, establishing credibility of the results offered by microbial forensic analysis performed by western states and/or made today in workshops and training have the ability to prepare the policy landscape for the day in which the source of a bio attack, either man-made or from nature, needs to be accurately attributed.

A full PDF version of the report can be found here.

The threat from the manufacture, proliferation, and use of biological weapons (BW) is a high priority concern for the U.S. Government. As reflected in U.S. Government policy statements and budget allocations, deterrence through attribution (“determining who is responsible and culpable”) is the primary policy tool for dealing with these threats. According to those policy statements, one of the foundational elements of an attribution determination is the use of forensic science techniques, namely microbial forensics. In this report, Christopher Bidwell, FAS Senior Fellow for Nonproliferation Law and Policy, and Kishan Bhatt, an FAS summer research intern and undergraduate student studying public policy and global health at Princeton University, look beyond the science aspect of forensics and examine how the legal, policy, law enforcement, medical response, business, and media communities interact in a bioweapon’s attribution environment. The report further examines how scientifically based conclusions require credibility in these communities in order to have relevance in the decision making process about how to handle threats.

A full PDF version of the report can be found here.

The first identified case of the Zika virus acquired in the continental United States has been confirmed in Texas, contracted via sexual transmission. The CDC is expected to release guidelines on sexual transmission, however relatively little is known. While it has been established that the virus remains in the blood for roughly a week, the viability in semen is yet to be determined. Find out more about the latest research developments of Zika virus at CNN: http://www.cnn.com/2016/02/02/health/zika-virus-sexual-contact-texas/

Hawaii, Illinois, Florida, and Texas have all recently reported travel-related cases of Zika virus, including two pregnant women who are being actively monitored. The virus has shown a strong association with fetal brain damage, but no treatment or vaccine is currently available. Last week, the CDC advised pregnant women to avoid traveling to countries where transmission of the virus has been reported. Read more at The Washington Post: https://www.washingtonpost.com/news/to-your-health/wp/2016/01/19/cdc-issues-guidelines-for-pregnant-women-returning-from-zika-affected-countries/

An investigation into the Army labs at Dugway Proving Ground in Utah, responsible for chemical and biological defensive testing, was launched last year after it was discovered to be accidentally shipping live anthrax to laboratories across the country for over a decade. The report reveals gaps that go far beyond that of poor leadership, and include a dozen personnel that are being held accountable and could face disciplinary action as a result. To read more about the findings of the Army investigation report, visit USA Today:  http://www.usatoday.com/story/news/nation/2016/01/15/military-bioterrorism-lab-safety/78752876/