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News | Dec. 22, 2025

Biotechnologies and the Treaty Gap: Why Biological Weapons Governance Is Falling Behind; and Some Thoughts on How to Fix It

By Dr. James Giordano Strategic Insights

Auld Lang Syne

(Scottish: “old long since”; viz., the “good old days”)

The Scottish ballad Auld Lang Syne, written in 1788 by poet Robert Burns is a tune traditionally played to ring out the passing year and herald in the new.  he lyrics offer an invitation to celebrate that which was good, and toast to what may come. In the Stockholm International Peace Research Institute (SIPRI) Yearbook for 2025, Prof. Filippa Lentzos of Kings College, London provides an outstanding overview of the past year’s developments in biological weapons control, current status of the Biological Weapons Convention (BWC) and related treaties, and international postures of compliance and oversight. As Prof. Lentzos notes, the pace and scope of biological science and technology development is such that the possibility for dual-use poses formidable challenges to a genuine attempt at signatory governance. Indeed, her conclusion that the forthcoming BWC review conference “will still have significant work to do” is telling. In short, while the BWC may have once been “good enough,” the trajectory of technology and its weaponizable potential have rendered the value of the current BWC to be “old long since…”

International agreements designed to restrict the creation of biological weapons were drafted to govern state-run programs that cultured pathogens in secure facilities, and created these agents for battlefield use. While that world has not disappeared, it has also been supplanted by strategically significant capabilities that are increasingly distributed, dually-usable, and fast-moving. Gene editing, synthetic biology, novel biotechnologies, automated biomanufacturing, AI-enabled design of proteins and organisms, and globalized supply chains that make advanced life science possible in universities, start-ups, and contract laboratories have all complexified the field of possible engagement. These developments do not render existing treaties obsolete, but they do expose a profound mismatch between what current treaties prohibit in principle and what they can surveille, interpret, and govern in real world practice.

The BWC remains the cornerstone of global biowarfare governance, and it is normatively powerful, banning the development, production, stockpiling, acquisition, and retention of biological agents and toxins “of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes.” But the BWC was developed to be a prohibitory instrument with comparatively limited operational adjudicative power. It requires states to take domestic measures to prevent prohibited activity, yet lacks a standing verification regime comparable to other arms control frameworks. This weakness has only grown more consequential as bioscience and biotechnology have become more accessible, applicable, and dual-use more ambiguous

This reality becomes ever more salient, and important given the United States’ recent moves to (1) employ tools and methods of artificial intelligence (AI) to assess and monitor global compliance with the BWC, and (2) fortify Department of Defense focus upon biotechnologies as a fundamental component of national strategic defense. Toward both of these goals, it becomes important to query if and to what extent biotechnologies are addressed by current treaties and conventions.

The contemporary biotechnology milieu has given rise to a grey zone wherein distinctions between capability and intent, and peaceful and hostile applications are becoming obscured. Treaties designed to ban ”weapons” can fall short when the “weapon” is not a discrete object but a workflow of data and design tools; DNA synthesis and iterative experimentation; and/or scalable bioprocessing and delivery vectors. This poses a governance challenge that can be exploited by sophisticated state programs and by non-state actors who can now assemble pieces of a once-centralized capability across borders.

Where’s the governance deficit?

To my view, there are five domains of governance deficit; these are:

1) Definitions that were functional in 1972 are now strained in 2025. The BWC’s “general purpose criterion” is intentionally broad; agents and toxins are prohibited when they lack justification for use in peaceful context(s). While that categorical breadth was instrumental to the treaty enduring scientific progress, it now situates modern disputes as interpretive arguments. At what point (of categorical nomenclature or use inflection) does platform technology (e.g., high-throughput gene editing, adaptive directed evolution, automated fermentation, bioengineered neurocognitive modulating devices) constitute “peaceful” research versus weapon capacity-building? The extant language of the BWC could certainly be used to condemn malicious products and outcomes, while remaining silent about the up-range activities that enable them.

2) Regnant verification and transparency mechanisms are insufficient for modern dual-use science. In practice, compliance confidence depends on visibility. The BWC lacks a dedicated mechanism for inspection, assessment and verification of compliance and deviation practices. It relies heavily on national implementation and confidence-building measures, which while noble in intent, vary in quality and participation. The absence of such evaluation and verification mechanisms weaken deterrence and detection in light of the dual-use nature of biotechnology. The intention to employ AI toward such ends is promising. But as we have noted, this might easily become a double-edged blade: the same algorithms that can be used for assessing BWC adherence or deviation could be modified by nefarious actors to subvert both the treaty and the AI being used to monitor its compliance!

3) Non-state actor risk is structurally under-governed. The BWC is a state-to-state treaty, yet modern biotechnology reduces barriers to participation. The 2004 United Nations Security Council Resolution (UNSCR) 1540 partially bridges this gap by requiring all states to adopt and enforce domestic controls to prevent non-state actors from developing, acquiring, or using (nuclear, chemical, or) biological weapons and related materials.  But the Resolution is not a laboratory governance framework; it is a promissory to build national legal and regulatory capacity. But nations are not universally adherent to UNSCR 1540, and such unevenness creates fault lines in oversight, governance and response.

4) Supply chains and “intangible transfers” outpace the constructs and language of the current BWC. Many sensitive capabilities can now be moved as digital information (sequence data, protocols, automated lab scripts) and virtual resources and services (cloud labs, contract research, distributed manufacturing). Export control regimes such as the Australia Group maintain common control lists for pathogens, toxins, and dual-use biological equipment. To be sure, such lists are an important tool, but they are voluntary, membership-limited, and cannot validly substitute for universal treaty obligations. 

5) The “cooperation” mandate of the BWC is entangled with security concerns. Article X of the BWC emphasizes and allows the exchange of materials and information for peaceful purposes. Yet states often disagree about how to balance scientific openness, equitable access, and biosecurity. This tension has intensified as biotechnology becomes economically strategic and as knowledge itself becomes a risk vector.

Why this risk matters beyond “arms control”

Biotechnology is now a pillar of national innovation strategies, public health security, and economic competitiveness. This creates two risks. First, it incentivizes ambiguity: when biomanufacturing and biodefense are closely coupled, states (and sometimes private actors) may prefer governance regimes that are strong on rhetoric but weak on intrusive transparency. Second, it creates latent weapons relevance: capabilities built for legitimate reasons (e.g., pandemic preparedness, vaccine platforms, biomedical research translation and clinical advancement, agricultural resilience) can forge novel pathways and shorten timelines for dual use.

Thus, the dangerous actor is not just one who overtly “builds a bioweapon” in the cinematic sense; but also one who uses advanced biotechnology to engineer plausible deniability, sidestep traditional pathogen lists, and/or exploit weak oversight in distributed systems. Don’t get me wrong, none of this should instigate restricting beneficial science and technology. But all of it argues for governance that is appropriate for the pace, types and multi-utility of the science and technology that currently exist, and that which today’s capabilities could enable in the near future.

Five recommendations for revisiting and working to resolve the oversight gap

I’m not one to point out and complain about “the dark” without proposing how to light — and sustain — a flame of illumination. In that spirit, I offer the following recommendations toward committed effort to closing the existing gap(s) in biotechnology monitoring and oversight to augment the focus, tenor and fortitude of the BWC:

1) Create a “living” biotechnology annex under the purview and auspices of the BWC, which is reviewed and updated routinely. The BWC’s general prohibitions should be operationalized through an annex-like mechanism that can be updated on a scheduled basis (e.g., bi-annually) to address emerging technologies and workflows. This should include a shared vocabulary for novel capabilities (e.g., automated design-build-test cycles, gene drives, cell-free systems); risk-graded categories of concern, and agreed-upon indicators of suspicious activity at the level of process and scale (not just lists of agents). This would sustain durability of the BWC by making it meaningfully interpretable as science and technology evolve.

2) Establish a transparent peer-review system that is “verification-adjacent.” If comprehensive inspection regimes remain politically difficult to execute, states could instead adopt a modular approach to transparency that increases confidence without positing the falsehood that dual-usability can be “fully verified.” This approach could include fortified and codified BWC confidence-building submissions; voluntary peer-review site visits, and a standing technical assessment capacity to evaluate contested questions regarding particular laboratories, biomanufacturing processes and the viability of specific output products to be weaponized. 

3) Harmonize global screening of DNA synthesis, and due diligence of science and technology producers and use-customers. One of the most actionable levers is up-range: gene-length DNA synthesis and related services. Thus, international baselines should require robust screening of sequences-of-concern; verification of producer and customer identity (and end-use checks for high-risk orders), and secure data storage, transfer and sharing using safeguards-by-design. Certainly, this does not eradicate the risk of bioweapon manufacture, but it meaningfully raises the bar and barrier(s) for malicious acquisition of weaponizable products in a global environment where sequence-to-material pipelines are increasingly commoditized and expedited.

4) Yoke treaty commitments to domestic implementation benchmarks in ways that leverage UNSCR 1540. UNSC Resolution 1540 already obligates states to adopt legislation and domestic controls to prevent bioweapon distribution and provision to non-state actors. Acting upon this, the BWC community should develop a more specific set of implementation benchmarks for biosafety/biosecurity, laboratory licensing, oversight of high-containment facilities, and enforcement, which could be paired with capacity-building assistance for those states that lack BWC compliance resources. In this way, (BWC) Article X cooperation could be aligned with the security of safe scientific capacity as a public good. 

5) Establish a multi-stakeholder governance forum that is linked to, but not constrained by the BWC. Bioscientific and biotechnological innovation is very much a private-sector and academic enterprise. Therefore, any governance that excludes these communities will remain aspirational at very least, if not ineffectual in the main. To counter this, a standing forum (that is linked to BWC processes, but not wholly constrained by them) should work to develop norms and best practices for dual-use review; coordinate incident reporting; and promote a “duty of care through compliance” culture across funders, journals, platforms, and research and development enterprises. Export control efforts like the Australia Group, and efforts toward strategic trade governance show how such coordination of dual-use practices and products can work effectively. But to echo Prof. Lentzos’s point, more diligent action, broader participation and clearer linkage to establishing universal (and enforceable) norms are needed.

Closing thoughts…

The BWC and related instruments helped to establish a global norm that biological weapons are beyond the pale. That norm still matters immensely. But norms do not automatically translate into governance that is adequate in a world of rapidly developing, highly distributed biotechnology. Thus, the task at hand is to preserve scientific openness and technologic innovation, and concomitantly reduce exploitability. I believe that to do this will require a move from a 20th-century model of listing and controlling “agents” toward a 21st-century vision of overseeing and governing “capabilities, workflows, and systems,” with transparency measures and implementation support that are sufficiently robust to make prohibition credible and deterrence feasible. I fear that failure to update governance architectures, while continuing to laud a treaty that declares bioweapons illegal, will enable quiet acceptance of a growing inability to detect, deter, and respond to the ways that modern biotechnology could be used for harm.

Disclaimer

The views and opinions presented in this essay are those of the author, and do not necessarily reflect those of the United States government, Department of War, or the National Defense University.

Dr. James Giordano

Dr. James Giordano is Director of the Center for Disruptive Technology and Future Warfare, Institute for National Strategic Studies at the National Defense University.