S14E1 - Christopher Cummings on Risk, Responsibility, and Standardization

Risk, Responsibility, and Standardization: Lessons from multiple NATO-Sponsored Biotechnology Workshops Christopher L. Cummings, Ph.D.

Research Social Scientist at the US Army Corp of Engineers and Senior Research Fellow at the GES Center, NC State University

About the speaker

Christopher L. Cummings, PhD, is a behavioral theorist and social science researcher specializing in risk perception, public engagement, and the governance of emerging technologies. He leads the Center for Health Engineering at the U.S. Army Engineer Research and Development Center, where he integrates behavioral science with engineering, risk analysis, and public health systems. At North Carolina State University, he is a Senior Research Fellow with the Genetic Engineering and Society Center and a Research Social Scientist with the NSF-funded Precision Microbiome Engineering Research Center, where he examines the societal and governance dimensions of biotechnology. Dr. Cummings has directed multiple NATO Advanced Research Workshops addressing biotechnology convergence, risk governance, standardization, and defense resilience. He also served on a National Academies committee reviewing environmental, biosafety, and biosecurity considerations for synthetic cell research. Author of more than 100 peer-reviewed publications and Secondary Risk Theory, his work connects technical risk assessment with public values, trust, policy acceptance, and strategic communication.

• Google Scholar >

---

Zoom Overview

This colloquium session, hosted by the Genetic Engineering and Society (GES) Center at NC State, featured a presentation by Dr. Christopher Cummings, Director of the Center for Health Engineering within the U.S. Army Corps of Engineers (ERDC) and Senior Research Fellow at GES. Dr. Cummings presented findings and lessons learned from a series of NATO-funded Advanced Research Workshops (ARWs) focused on biotechnology risk, responsibility, and standardization. The talk addressed the growing gap between rapidly advancing biotechnologies and the governance frameworks intended to oversee them, with particular emphasis on the need for international standards, adaptive governance, and responsible innovation.

Key Concepts or Theories

• The Pacing Problem: The phenomenon where technological development outstrips the pace of regulatory and governance responses
• Standards as Governance Tools: The use of voluntary, flexible, and performance-based standards as a bridge between hard law and rapid innovation
• ELSI (Ethical, Legal, and Societal Implications): A framework for identifying non-technical barriers across the biotechnology development pipeline
• TAPIC Model: A governance values framework comprising Transparency, Accountability, Participation, Integrity, and Capacity
• Soft Law: Non-binding governance mechanisms such as voluntary consensus standards, codes of conduct, and ethics guidelines used to guide behavior in the absence of formal legislation
• Information Hazards: Situations where scientific knowledge itself poses a potential risk if disseminated without appropriate safeguards
• Interoperability: The ability of different nations and sectors to use shared technical and safety standards to collaborate effectively across borders

Important Questions Raised

• How can international standards be developed that respect national regulatory differences while enabling cross-border collaboration?
• What are the risks and hazards of standardization itself, including blind spots and power imbalances?
• How do information hazards from AI-enabled biotechnology get governed before they cause harm?
• How can data sharing be encouraged in a competitive landscape where both market and national security interests incentivize secrecy?
• How do human values get institutionalized into technology governance in a durable, evolving way?
• What role does public perception, misinformation, and media framing play in shaping biotechnology investment and policy?

Key Takeaways and Summary of Learning Objectives

• Biotechnology is advancing at a pace that far outstrips existing governance and regulatory frameworks — a phenomenon known as the "pacing problem."
• Standards, particularly flexible and performance-based ones, can serve as effective governance tools to bridge the gap between innovation and regulation.
• Non-technical barriers — including public trust, ethical concerns, and misinformation — are significant drivers of biotechnology failure in the marketplace.
• International collaboration through forums like NATO Advanced Research Workshops is essential for developing shared frameworks and fostering cross-sector trust.
• Data sharing remains a critical and unresolved challenge, complicated by both market competitiveness and national security concerns.
• The TAPIC model (Transparency, Accountability, Participation, Integrity, Capacity) offers an aspirational framework for responsible governance.
• AI and biotechnology convergence is creating new and compounding risks that current governance structures are ill-equipped to handle.
• Responsible Research and Innovation (RRI) principles, including early ELSI assessment, can help anticipate and mitigate downstream societal harms.

Topic 1: Background and Context — Dr. Christopher Cummings and the NATO Advanced Research Workshops

Dr. Christopher Cummings introduced himself as an NC State alumnus who began his career as a communication scholar studying political rhetoric before being drawn into science and risk communication through a nanoparticles research grant. Over time, his work evolved to span academic, governmental, and international domains. He currently leads the Center for Health Engineering within the U.S. Army Corps of Engineers (ERDC), where his team conducts highly academic research in service to government, including work for the Principal Director for Biotechnology in the Office of the Undersecretary of War.

Dr. Cummings has directed multiple NATO-funded Advanced Research Workshops (ARWs), including a 2024 meeting in Malta focused on biotechnology standards, and an upcoming April workshop in Brussels on biomanufacturing standards across the NATO enterprise. These workshops bring together experts from across NATO member nations to identify emerging problems, deliberate in working groups, and produce actionable publications and frameworks. He also noted his recent appointment to the National Academies Committee on the External Review of Environmental Biosafety and Biosecurity Considerations for Synthetic Cell Research and Development.

Relevant Q\&A

Question: How do you get industry participants to show up and genuinely participate in these workshops?

Answer: Dr. Cummings explained that industry participants benefit from direct access to national leaders and decision-makers who can influence commercialization pathways. The workshops also provide visibility into larger international conversations that directly affect R\&D agendas, which is valuable even for participants who are focused on narrow technical work.

Topic 2: The Pacing Problem and the Role of Standards in Biotechnology Governance

A central theme of Dr. Cummings' presentation was the "pacing problem" — the persistent gap between the speed of biotechnology development and the ability of governance systems to keep up. Technologies such as CRISPR, AI-driven biology, and synthetic biology are evolving exponentially, while regulatory responses remain slow and incremental. Traditional hard law is too rigid and time-consuming to address rapidly emerging risks effectively.

Dr. Cummings argued that standards — particularly voluntary, performance-based, and adaptive standards — offer a practical alternative. Unlike hard law, standards can be updated more quickly, provide clarity for developers and investors, and enable a degree of international consistency even amid regulatory divergence. He emphasized that a one-size-fits-all approach will not work given the breadth of biotechnology across health, agriculture, energy, environment, and defense sectors.

Key lessons from the NATO ARWs include:

• Divergent national approaches create duplication, trade barriers, and collaboration failures
• Interoperability at key junctions such as tech transfer and international trade is essential
• Conformance testing and certification should be required before widespread product use
• Global data sharing and biosafety validation best practices are critical but remain contested
• Performance-based standards that focus on outcomes rather than rigid procedural rules are better suited to biological complexity

Historical examples such as the failure of Golden Rice due to lack of public trust, the 15-year regulatory delay of the AquAdvantage salmon, and preemptive state bans on cell-cultured meats illustrated the real-world consequences of neglecting non-technical barriers.

Relevant Q\&A

Question: Is the intersection of AI and biotechnology — including the potential to generate functioning pathogens — a topic discussed at these workshops?

Answer: Dr. Cummings confirmed that information hazards are a central concern. He noted that top journals already screen submissions for potentially dangerous knowledge, and that his colleague Dr. Benjamin Trump is actively working with AI companies to implement guardrails. He also noted that AI can be used defensively — for example, to accelerate vaccine development — and that alarming headlines, while concerning, can serve a useful agenda-setting function by prompting government action.

Question: Could you speak more about negative labeling and its parallels to AI-enabled products?

Answer: Dr. Cummings noted that the GMO debate became so contentious that the U.S. government eliminated the term entirely, replacing it with "bioengineered" under a national standard. He expressed concern that similar dynamics are emerging around AI-enabled products, particularly given EU AI Act labeling requirements taking effect in December.

Topic 3: Misinformation, Public Trust, and Investment Dynamics in Biotechnology

Dr. Cummings highlighted that misinformation, disinformation, and malinformation are creating structural barriers to biotechnology development. Negative public messaging — sometimes deliberately amplified by competing nations seeking to suppress U.S. biotech investment — is causing venture capital to withdraw from the sector. This dynamic is particularly visible in novel agri-food biotechnologies, where public opposition has led to preemptive legislative bans even before products reach the market.

He emphasized that public opinion research is a core part of his work, and that understanding the factors driving public decision-making is essential to responsible governance. He also noted the irony that investors who pivoted away from biotech toward AI are now facing similar public backlash, suggesting that no sector can ultimately avoid reckoning with public values.

Relevant Q\&A

Question: On data sharing — is the barrier primarily market competitiveness or national security?

Answer: Dr. Cummings confirmed it is both. Even individual academic researchers resist immediate data sharing to protect their ability to publish. In industry, intellectual property systems partially address market competitiveness, but national security data sharing involves additional layers of complexity. The rapid pace of digital communication and the risk of data breaches further complicate the landscape, particularly with the computational power of modern AI systems.

Question: From Bill Kinsella (online): Are there hazards in standardization itself — blind spots, power imbalances, and the suppression of diverse perspectives?

Answer: Dr. Cummings acknowledged these risks fully, noting that the outcomes of ARWs are aspirational and that walking the walk remains difficult. He expressed confidence that adhering to governance values like TAPIC can help minimize these hazards, while acknowledging that human fallibility means perfect outcomes are unlikely.

Topic 4: Building the Future — Recommendations for Responsible Biotechnology Governance

Dr. Cummings concluded with a set of overarching recommendations drawn from the collective wisdom of ARW participants:

1. Balance speed and safety: Use flexible standards and shared best practices to narrow the gap between innovation and regulation
2. Build cross-sector bridges: Develop frameworks that link sectors and stages of development so that knowledge and standards travel with the technology from lab to marketplace
3. Embrace performance standards: Favor outcome-based benchmarks over overly prescriptive rules to better accommodate biological complexity and rapid change
4. Foster global cooperation: Use soft law tools, data sharing networks, and international forums to build trust and enable coordination across nations
5. Embed shared responsibility: Recognize that risk and responsibility in biotechnology are collective, and that internationally coordinated, agile, yet accountable governance is essential to realizing biotechnology's promise safely and equitably

Dr. Cummings also advocated for the continuous injection of social science into technology development and governance, arguing that better understanding of public values — and ensuring those values are reflected in how technologies are developed and deployed — is fundamental to responsible innovation.

Relevant Q\&A

Question: Is there a higher-level framework that can transcend the time-consuming, detail-level work of harmonizing standards across countries with different IP and regulatory systems?

Answer: Dr. Cummings pointed to Dr. Jennifer Kuzma's work on proactive, adaptive, and resilient governance mechanisms as a model. He noted that ARW participants found discussions around shared human values more productive than attempts to align on specific technical benchmarks. However, he acknowledged the challenge of institutionalizing values in a durable way, given staff turnover and evolving societal norms. His recommendation was to continuously integrate social science research to keep governance anchored to current public values.

Actionable Next Steps / Assignments

• Attendees interested in meeting with Sam Weiss-Evans, who is visiting from DC the following week to give a GES colloquium talk, were asked to reply to the email circulated by the host to schedule time.
• Dr. Benjamin Trump is scheduled to present in two weeks on AI convergence and related governance topics; attendees were encouraged to attend for follow-up on themes raised in this session.

Supplemental Resources

• Book: Biotechnology and AI: Technological Convergence and Information Hazards — co-authored by Dr. Benjamin Trump, Dr. Christopher Cummings, and colleagues; produced from the NATO ARW held in Cartagena, Colombia. A QR code was displayed during the presentation linking to this publication.
• TAPIC Model: Referenced from Scott Greer's work on governance values — Transparency, Accountability, Participation, Integrity, and Capacity — as a framework for evaluating and improving governance systems.
• Upcoming NATO ARW: Building the Defense Industrial Base Across the NATO Enterprise: Applying Biomanufacturing Standards to Expand International Markets — to be held at NATO HQ in Brussels in April; relevant for those interested in biomanufacturing, standards, and international security policy.
• Dr. Jennifer Kuzma's work on proactive and adaptive governance mechanisms for emerging biotechnologies was referenced as a key resource for those interested in forward-looking regulatory frameworks.

__ 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