570. Breaking (Bad) Biotech — Revisiting the Biological and Toxin Weapons Convention

[Editor’s Note:  Army Mad Scientist welcomes back frequent collaborator and proclaimed Mad Scientist Dr. James Giordano, head of the Center for Strategic Deterrence and the Study of Weapons of Mass Destruction, with a new submission. In today’s post, Dr. Giordano explores how advances in biotechnology, like gene editing and AI, allow adversaries to easily create novel, weaponizable biological agents that are difficult to detect and defend against. In an evolving operational environment, the nature of biological warfare has shifted. — Enjoy!]

Breaking (Bad) News on the Uses of Biotech:

1. 1. 1. Thousands of vials of suspicious materials, some labeled as pathogenic bioagents, laboratory equipment, cold storage and refrigeration units were discovered in a private home in Reedley, California.
      2. European allies at the Munich Security Conference reported that epibatidine, a highly potent neurotoxin derived from non-indigenous poison dart frogs, was used to poison Russian opposition leader Alexei Navalny.

These stories bring to light a disturbing convergence of biological risk vectors that extend well beyond the historical paradigms envisioned when the Biological and Toxin Weapons Convention (BWC) was established in 1972.  Although currently framed by the international community as a violation of the Chemical Weapons Convention (CWC), the Navalny case raises fundamental questions about whether and how regnant international classification standards, treaties, and verification mechanisms can contend with the dual-use capacity of emerging biotechnologic tools and methods, including gene editing, synthetic biology, and the force multiplying effects of big data and artificial intelligence (AI) that enable creation, dissemination, and concealment of novel forms of existing agents, as well as those that are newly formulated.

The California case illustrates that biotechnology has progressed from capabilities in pathogen isolation and basic culture to advances in molecular design, sequence manipulation, and synthetic pathways that enable development of more viably weaponizable drugs, microbes and toxins. This underscores the clear and present need for a revised, robust, and operationally relevant iteration (and interpretation) of the BWC that explicitly addresses these emergent risks and threats.

Such cases highlight three salient points. First, toxins (like drug and microbial research) are dually usable and thus straddle the fundamental ambit of the current BWC against agents with no justifiable medical purpose, and the CWC’s prohibitions on toxic chemicals. Second, the tactical and strategic exploitation of biological molecules, especially through clandestine or unconventional means, is a demonstrated reality with geopolitical reverberations; and third, that technological convergence facilitates ease and accessibility of both benign innovation and potential misuse in ways that challenge existing regulatory frameworks.

To the first, and perhaps most sentinel point, I opine that the BWC’s general-purpose criterion, which prohibits the development, production, stockpiling, and retention of biological agents or toxins “of types and in quantities that have no justification for prophylactic, protective, or other peaceful purposes”, has become conceptually capacious. This language, while seeming to have considerable normative power, has proven to be operationally inapt in addressing how newly designed agents and synthetic constructs might be created, stored and deployed in ways that can sidestep conventional biodefense and arms control governances.

Dealing with Dual-Use Realities and De-limiting the BWC.

To the second and third points, current reality reveals that since the BWC’s establishment in the early 1970s, the life sciences have undergone a transformative technologic evolution. Technologies such as CRISPR-Cas systems, oligonucleotide synthesis, and modular synthetic biology platforms now allow precise genotypic and phenotypic bioengineering at scales and speeds that were beyond the pale of consideration at the treaty’s inception. Current biologic tools and techniques enable: 1) expedited sequencing and synthesis timeframes for creating novel agents from digital templates with minimal physical infrastructure; 2) metabolic pathway engineering and chimeric constructs to produce agents that could evade detection or display atypical pathogenic features; and (as the Reedley California case demonstrates); 3) lower technical barriers, so that individual actors or small laboratories can manipulate biological systems without cooperation (or oversight) of large research entities.

The BWC lacks operational mechanisms for verification, compliance assessment, or enforcement that are comparable to those of the CWC or the Non-Proliferation Treaty. While BWC review conferences have acknowledged scientific and technological developments, they have not led to meaningful revisions toward operationalizing normative intentions or formulating binding, verifiable obligations. Moreover, state implementation of preventive measures, as required under Article IV, can vary widely, thereby creating regulatory heterogeneity that malign actors could readily exploit.

Thus, I believe that the U.S. and its allies pursue a comprehensive revision of the BWC that incorporates explicit, proactive provisions to address risks posed by emerging methods and uses of biotechnology, such as gene editing and synthetic biology. This modernization should encompass several core elements, to include:

A clarified definition of emerging biothreats: The BWC should be revised to recognize that technology, not taxonomy, now defines risk. To wit, definitions should be expanded to include both traditional biological agents as well as synthetic constructs and engineered agents (whether derived from natural organisms or created anew) that could be used for hostile purposes.

1. 1. 1. Operationalized verification and compliance mechanisms: Without verification protocols (e.g.- on-site inspection capabilities, sample analysis frameworks, and confidence-building measures) the BWC will remain reliant on political desire rather than empirical assessment. Integrating scalable verification mechanisms would be instrumental toward deterring misuse and reinforcing norms
      2. Development of pragmatic governance framework(s) of digital (i.e.- AI-driven) bio-engineering tools: Research has shown that advanced computational models can be used to formulate and develop pathogenic bioagents. Thus, the BWC must incorporate language and frameworks that govern digital bio-design  and coordinate safeguards across the physical, natural and life sciences, information technology, and (inter)national security domains.
      3. Homogeneity of national oversight and implementation processes: Article IV’s requirement that states “take any necessary measures” to prohibit development and misuse must be clarified to define necessary measures via benchmarks, timelines, and accountability. Such uniformity in norms and standards would reduce regulatory gaps that could be easy to exploit.
      4. Establishment of multilateral response frameworks: Effective deterrence and rapid attribution require international mechanisms for real-time data sharing, forensic analysis, and coordinated responses. These capabilities should be formalized within an enhanced BWC structure to preclude ad hoc, reactive policymaking.

The operational implications of such revisions are multifold, and include:

• • • Deterrence: A modernized BWC would fortify deterrence by reducing ambiguity about what constitutes a prohibited capability, and by enabling credible compliance assessment.
• • • Force Protection: These revisions help ensure that military biomedical research and defensive efforts remain within a framework that avoids misinterpretation and mitigates escalation.
• • • Allied Interoperability: Harmonized standards facilitate intelligence sharing, joint biodefense planning, and coalition surveillance/monitoring and response operations.
• • • Strategic Messaging: Reinforcing the norms against misuse (and mishandling) of weaponizable bioagents strengthens global stability and aligns with ethical principles upheld by democratic societies.

Conclusion

The breaking news relayed in this essay illustrates that biological threats are no longer confined to natural pathogens, overt delivery systems, or large national laboratory facilities. The convergence of gene editing, synthetic biology, ramped-up dual-use research, and increased accessibility underscores vulnerabilities that the existing BWC was not designed or articulated to manage. Simply put, change happens, and in the biotechnology space it is happening fast. To protect national and allied interests, it will be important, and I argue necessary, to revise the BWC to be as agile and adaptive as the technologies that define the emerging battlespace.

 

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Our T2COM OE Threat Assessment 1.0, The Operational Environment 2024-2034: Large-Scale Combat Operations

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Our North Korea Landing Zone, including Resources for Studying North Korea, Instruments of Chinese Military Influence in North Korea, and Instruments of Russian Military Influence in North Korea.

Our Irregular Threats Landing Zone, including TC 7-100.3, Irregular Opposing Forces, and ATP 3-37.2, Antiterrorism (requires a CAC to access).

Our Running Estimates SharePoint site (also requires a CAC to access) — documenting what we’re learning about the evolving OE (including Russia’s war in Ukraine war since 2024 and other ongoing competitions and conflicts around the globe).  Contains our monthly OE Running Estimates, associated Narratives, and the quarterly OE Assessment Intelligence Posts.

About the Author:  Proclaimed Mad Scientist Dr. James Giordano is head of the Center for Strategic Deterrence and the Study of Weapons of Mass Destruction, and leads the Program in Disruptive Technology and Future Warfare of the Institute for National Strategic Studies.

Disclaimer: The views expressed in this blog post do not necessarily reflect those of the U.S. Department of War, Department of the Army, or the U.S. Army Transformation and Training Command (T2COM).