Transforming American Biosecurity: How the biosecurity governing landscape is changing and how you can help

Sam Weiss Evans, D. Phil., Senior Advisor at the Federation of American Scientists

About the speaker

Dr. Sam Weiss Evans is a Senior Advisor at the Federation of American Scientists (FAS). At FAS, Sam is working to bring about foundational biosecurity and biosafety governance reform. He recently completed a term as a Senior Policy Advisor for the National Security Commission on Emerging Biotechnology, where he led the Commission’s work on biosecurity, biosafety, standards, and responsible innovation. Prior to joining NSCEB, Sam was a Senior Research Fellow at Harvard University, jointly with the Kennedy School of Government’s Program on Science, Technology & Society, and the School of Engineering and Applied Sciences. He has spent the past twenty years studying and building experimental governance capacity in bioengineering and several other areas of emerging technology and holds a D.Phil. from Oxford University.

Related links:

---

Zoom Overview

This colloquium talk, delivered by Sam Weiss Evans of the Federation of American Scientists, addressed the current state of biosecurity governance in the United States and the need for systemic reform. Drawing on his experience at the National Security Commission on Emerging Biotechnologies and the Harvard Kennedy School, Sam presented a critical analysis of how the U.S. currently manages biosecurity threats and proposed a more structured, cyclical approach to governance. The talk was the second in a series on biosecurity and related governance issues hosted by the Genetic Engineering and Society (GES) Center.

Key Concepts or Theories

  • Whoops-Then-Fix (WTF) Governing: The current reactive model of biosecurity governance, where policy responses are triggered only after problems emerge, often resulting in fragmented and ineffective oversight.
  • Design-Build-Test-Learn Cycle: A proposed alternative governance framework borrowed from engineering, emphasizing iterative assessment, innovation, testing, and deployment of biosecurity policies.
  • Biosecurity Whack-a-Mole: A metaphor describing the issue-by-issue reactive approach to biosecurity, where attention jumps between emerging threats without addressing systemic root causes.
  • Paradigm Shift (Kuhnian Framework): The application of Thomas Kuhn's concept of scientific revolutions to biosecurity governance, using anomalies in the current system to justify and drive structural reform.
  • Fractal Democracy: A concept introduced to describe a governance model that maintains democratic contestability at multiple levels, allowing diverse communities to have a say in how biosecurity concerns are addressed.
  • Gene Synthesis and Digital-to-Physical Biology: The process of converting digital genetic code into physical biological constructs, identified as a key governance gap with at least 7 federal agencies holding partial jurisdiction but no unified oversight.

Important Questions Raised

  • Where has biosecurity governance gone wrong such that it needs reform?
  • Who should be in charge of tracing the entire lifespan of a new biotechnology?
  • How do we balance valuable community feedback with potential public misunderstanding of complex biotechnologies?
  • How can moratoriums be replaced or supplemented with more robust, scalable governance structures?
  • What can the U.S. learn from international examples of biosecurity and biotechnology governance?
  • What is the one small, achievable action individuals can take to contribute to biosecurity reform?

Key Takeaways and Summary of Learning Objectives

  • The current U.S. biosecurity governance system operates reactively, addressing threats only after they emerge rather than proactively building systemic capacity.
  • Biosecurity oversight is fragmented across at least 7 federal agencies, none of which holds a complete picture or full authority over emerging biotechnology risks.
  • A design-build-test-learn cycle, adapted from engineering, offers a more coherent and iterative model for biosecurity governance reform.
  • Moratoriums, while useful as temporary pauses, are insufficient as long-term governance tools and must be replaced by structured, scalable systems.
  • The loss of Chevron deference has complicated agencies' ability to independently govern new and emerging technology spaces.
  • International examples, such as Indigenous-led innovation governance in Canada and New Zealand, offer valuable methodological insights for U.S. reform efforts.
  • Individuals can contribute to biosecurity reform through research, policy writing, fellowship programs, shaping funding landscapes, and joining government bodies.
  • The single most impactful small action is to consistently ask "whose science?" and "for whom?" when engaging with claims about scientific objectivity and research priorities.

Topic 1: The Failure of Current Biosecurity Governance

The existing U.S. biosecurity governance structure is characterized by what Sam Weiss Evans calls a "whoops-then-fix" (WTF) methodology. Rather than proactively building governance capacity, the system waits for a problem to emerge, then reaches for the nearest available tool and places it wherever is most politically expedient. This has resulted in biosecurity responsibilities being scattered across multiple agencies — each established in a different era, with different mandates and cultures — none of which can see or manage the full picture.

A central example is the governance of gene synthesis, the process of converting digital genetic sequences into physical biological constructs. Despite over 20 years of awareness of this governance gap, no binding federal requirements exist to restrict what sequences can be synthesized. At least 7 agencies hold partial jurisdiction, yet none has the authority or appetite to unify oversight without top-level White House support and sustained political will.

This fragmented system persists in part because it is functionally convenient for all stakeholders: companies appear responsible by raising concerns, agencies appear responsive by reacting to them, and the hype cycle around emerging biotechnology keeps funding flowing. However, the system produces few substantive obligations and is largely performative — effective only as long as nothing seriously goes wrong.

Relevant Q\&A

Question (online, Daryl Stover): Where has biosecurity gone wrong such that it needs reform?

Answer (Sam Weiss Evans): The system is structured around reactive, issue-by-issue responses rather than systemic reform. Biosecurity concerns are spread across the government in ways that made sense at specific historical moments but are now misaligned with the pace and complexity of emerging biotechnology. The result is a performative system that satisfies appearances without producing substantive safety improvements.

Topic 2: A Proposed Reform Framework — The Design-Build-Test-Learn Cycle

Sam Weiss Evans proposed restructuring biosecurity governance around a design-build-test-learn cycle, adapted from engineering practice. This framework clusters biosecurity reform into four phases: assessment, innovation, testing, and deployment.

In the assessment phase, the goal is to understand what is actually working in practice, including through no-fault reporting systems for laboratory incidents — a capability the U.S. currently lacks systematically. The NIH is currently proposing a national biosafety analysis center, and its draft guidelines are open for public comment. An equivalent of the National Transportation Safety Board (NTSB) for biotechnological events could enable root cause analysis and feed lessons back into governance design.

In the innovation phase, the focus shifts to creating new organizational and financial structures for biosecurity — including novel funding mechanisms, market incentives, and research and development frameworks that embed safety and security considerations from the earliest stages of ideation through publication and beyond.

In the testing phase, governance prototypes would be stress-tested in sandboxed environments before full deployment, with appropriate legal infrastructure already in place to enable this.

In the deployment phase, successful governance innovations would be rolled out — whether as new training programs, regulations, or technical infrastructure such as AI model weighting systems.

This cycle contrasts sharply with the current system, where each new biosecurity concern requires rebuilding the entire governance apparatus from scratch, consuming enormous resources and time.

Relevant Q\&A

Question (audience): In the IT world, beta testing covers many of the problems you mentioned, including whack-a-mole. To what extent could that model be adopted in biosecurity?

Answer (Sam Weiss Evans): Cybersecurity and IT development offer a rich set of analogies for biosecurity governance, and this is an underexplored area. However, a key distinction is that biological "bugs" are actual living organisms that can evolve and are far harder to control than software bugs. That said, the cybersecurity industry grew from nothing into a multi-trillion-dollar sector, and biosecurity has the potential to follow a similar trajectory.

Topic 3: Paradigm Shift and Strategies for Reform

Sam Weiss Evans framed the needed governance transformation as a Kuhnian paradigm shift — one driven by the accumulation of anomalies that the current system cannot adequately handle, such as gene drives, cloud labs, and autonomous laboratories. He outlined four interconnected strategies for achieving this shift:

  1. Narrative Structure: Telling a compelling story about what an alternative governance system could look like, using the design-build-test-learn framework to help stakeholders think outside the constraints of the existing system.
  2. Networks: Building coalitions of influencers, legislators, agency officials, and practitioners who can carry the reform message and staff new governance institutions.
  3. Proposals: Generating policy options that are grounded in the broader reform framework rather than tied only to the immediate whack-a-mole moment, ensuring they connect to lasting structural change.
  4. Moments: Leveraging crisis moments — such as the current wave of government restructuring — to ask foundational questions about governance that would otherwise be politically impossible to raise.

Sam also introduced the concept of "code switching" in biosecurity — reframing biosecurity not as a compliance burden on research and innovation, but as a source of innovation in its own right, opening new pathways for responsible biotechnology development.

Relevant Q\&A

Question (audience): How important is it to implement actual laws rather than relying on moratoriums for technologies like germline editing and gene drives?

Answer (Sam Weiss Evans): Moratoriums are not inherently bad — they provide a pause for assessment and system design. However, they are insufficient as long-term tools. The goal should be to build a governance system robust enough that, when a new concern arises, there is already a structured process to assess it, prototype a response, test it, and deploy it — potentially within six months. Without that infrastructure, moratoriums will remain the default, and the system will continue to require rebuilding from scratch each time.

Topic 4: International Perspectives and the Role of Community Knowledge

Sam Weiss Evans acknowledged that U.S. biosecurity governance has historically been resistant to learning from other countries, partly due to a post-World War II cultural assumption that domestic innovation is superior. Nevertheless, he highlighted meaningful international examples, particularly from Canada and New Zealand, where Indigenous and First Nations communities have been meaningfully included in research and innovation governance. These inclusive processes have generated innovation trajectories that would not have emerged otherwise.

On the question of community knowledge and public misunderstanding, Sam cautioned against the assumption that better public understanding of science would automatically lead to better policy. He argued that misunderstanding flows in multiple directions — institutions themselves often misunderstand how science is practiced on the ground, and biosafety officers with direct knowledge of laboratory inadequacies have no structured pathway to feed that knowledge into top-level policy design. The NIH's recent revision of recombinant DNA research guidelines, which involved listening sessions across the country over two years, was cited as a gold-standard example — but one that needs to happen regularly, not once every 40 years.

Relevant Q\&A

Question (audience): Who should be in charge of tracing the whole lifespan of a new biotechnology, and how should we balance valuable community feedback with public misunderstanding?

Answer (Sam Weiss Evans): Outside of the Department of Defense, no government body currently has a whole life-cycle view of research and innovation. The question of who should hold that responsibility is not being asked enough. On community knowledge, the issue is not simply public misunderstanding — institutions also misunderstand how science is practiced in real-world conditions. Knowledge flows in all directions, and the goal should not be to simply educate the public, but to build systems that recognize and integrate multiple forms of knowledge.

Question (online): What is the one small, achievable thing you most want to happen?

Answer (Sam Weiss Evans): Whenever someone invokes "the science" as a definitive authority, ask: "Whose science? For whom? Why were these questions asked and not others?" Asking these questions consistently begins to reveal the political and economic dynamics that structure research and innovation — and engaging with those dynamics is where meaningful reform starts.

Actionable Next Steps / Assignments

  • Attend the next GES Colloquium talk by Ben, scheduled for next week, which will cover the Chevron doctrine and its implications for agency governance.
  • Review the NIH's proposed revisions to recombinant DNA research guidelines, currently open for public comment for a limited period, and consider submitting feedback.
  • Explore fellowship and training opportunities in biosecurity, including the Johns Hopkins Emerging Leaders in Biosecurity Initiative, AAAS Congressional Fellowships, TechCongress Fellowships, and Horizon Fellowships.
  • Consider how your own research or policy work can be connected to the broader design-build-test-learn reform framework rather than addressing only immediate, issue-specific concerns.

Supplemental Resources

  • Johns Hopkins Emerging Leaders in Biosecurity Initiative: A fellowship program for those seeking training and career development in biosecurity policy.
  • AAAS Congressional Fellowship: An opportunity to work within Congress on science and technology policy, including biosecurity.
  • TechCongress Fellowship: A fellowship focused on technology policy within the U.S. Congress.
  • Horizon Fellowships: Fellowships specifically oriented toward biosecurity policy and government engagement.
  • NIH Proposed Revisions to Recombinant DNA Research Guidelines: A current policy document open for public comment, including proposals for a no-fault biosafety reporting system. Available through the NIH website.
  • Thomas Kuhn, The Structure of Scientific Revolutions: Referenced during the talk as a theoretical framework for understanding paradigm shifts in governance and knowledge systems.

__ Recorded from NC State’s GES Colloquium, this podcast examines how biotechnologies take shape in the world: microbiome engineering in built environments, gene editing and gene drives, forest and agricultural genomics, data governance and equity, risk and regulation, sci-art, and public engagement in practice.

Genetic Engineering and Society Center

Colloquium Home | Zoom Registration | Watch Colloquium Videos | LinkedIn | Newsletter

GES Center at NC State University—Integrating scientific knowledge & diverse public values in shaping the futures of biotechnology.

Produced by Patti Mulligan, Communications Director, GES Center, NC State

Find out more at https://ges-center-lectures-ncsu.pinecast.co

Rss Apple Podcaster
Podden och tillhörande omslagsbild på den här sidan tillhör Patti Mulligan. Innehållet i podden är skapat av Patti Mulligan och inte av, eller tillsammans med, Poddtoppen.