Global Biosecurity in the Age of Low-Probability, High-Consequence (LPHC) Biological Risks-

Some risks are just not worth the possible rare outcomes. The problem is how to identify, monitor, and prevent unacceptable risk-taking in an age of LPHC Biological threats

The evaluation and opinions expressed below are those of the author, and do not represent positions or viewpoints of the United States Government, the US State Department, or the US Department of Health and Human Services.

Overview

The Biological Weapons Convention was developed in the late 1960s and early 1970s, opened for signature in 1972, and entered into force in 1975. It was the first multilateral treaty to comprehensively ban an entire category of weapons of mass destruction. This multilateral treaty establishes strong international norms that reject the development, production, and use of biological weapons, but it remains institutionally weak, lacking verification, enforcement, and inspection mechanisms As a result, while it is effective as a moral and legal prohibition, it is poorly equipped to detect, deter, or manage accidental, dual-use, and emerging biological risks that fall short of explicit treaty violations.

In particular, the current version of the Biological Weapons Convention does not directly address modern low-probability, high-consequence biological risks associated with advanced biotechnology research and development. It is primarily designed to prohibit the deliberate development and use of biological weapons by states, leaving accidental releases, dual-use research (including gain of function) with catastrophic potential, systemic failures, and preparedness for worst-case biological events largely outside its scope.

Low-probability, high-consequence (LPHC) biological risks pose a distinctive risk management challenge because their rarity belies the scale of devastation they could inflict on global health, security, and stability. These types of risks are unlikely to occur in any single year but could cause catastrophic global harm if and when they do manifest. Identification and mitigation of LPHC biological risks requires international consensus and governance frameworks that move beyond traditional, state-centric regulation to address transboundary technologies, systemic uncertainty, catastrophic worst-case outcomes, and the wide range of state, non-state, academic, and commercial interests that drive these risks. Updated, innovative governance approaches to address these threats must go beyond standard national regulatory frameworks and embrace international coordination, develop shared norms, enable robust oversight mechanisms, and incorporate new information technologies capable of effective risk monitoring.

The COVID-19 pandemic and other recent outbreaks have demonstrated how biological risks can propagate across borders, overwhelming health and political systems while disrupting trade, travel, and societal stability. Preventing and mitigating such events requires global cooperation on surveillance, preparedness, and response capacity rather than isolated national action. Experts argue that governance should explicitly incorporate systemic impacts, uncertainty, and worst-case scenario planning, rather than relying solely on traditional risk assessments that underweight rare but extreme outcomes.

Emerging biotechnology innovations, which may be developed internationally, particularly those with transboundary ecological or health impacts, underscore the need for bilateral or multilateral governance structures, shared decision-making frameworks, and international consensus on prohibitions.

For example, gene drives (man-made genetic systems designed to bias inheritance and spread a trait through a wild population) have been proposed and even developed to suppress disease vectors or invasive species. Yet because these man-made gene drives can persist and spread beyond intended boundaries, potentially with irreversible ecological effects, robust international risk assessment, public engagement, and international governance mechanisms are recommended before any environmental release. Without agreed international standards for ecological risk assessments and public accountability, unilateral deployment could produce unintended consequences and erode trust among states and communities.

Similarly, gain-of-function (GOF) research, which seeks to enhance pathogen transmissibility or virulence to understand biological mechanisms and anticipate natural evolution, has sparked debates over risk, benefits, and oversight. While some analysts emphasize that enhanced pathogen research may help improve bio-surveillance or countermeasure development, there is broad recognition that inadequate governance and oversight can expose the world to catastrophic laboratory accidents or misuse.

The challenges of defining what constitutes “dangerous” GOF work and aligning oversight across jurisdictions underscore the difficulty of managing such risks unilaterally. International norms and frameworks for assessing, approving, and monitoring high-risk research are essential to ensure both safety and scientific progress.

Across these examples, best practices for managing low-probability, high-impact biological risks at multilateral or bilateral international levels should include strengthening global biosafety and biosecurity standards, enhancing information sharing, and institutionalizing mechanisms for early warning and coordinated response.

Policy experts recommend reinforcing foundational multilateral instruments, such as the Biological Weapons Convention, and exploring new binding or voluntary frameworks that extend beyond traditional treaty obligations to include monitoring, verification, and accountability. Equally important is investing in ongoing multilateral dialogue and technical collaboration to build trust, reduce capacity disparities, and ensure that governance frameworks can adapt as technologies evolve.

Ultimately, international governance of Low-Probability, High-Consequence biological risks requires a shift from reactive crisis management to proactive, collaborative stewardship, involving embedding risk assessment and mitigation into global scientific and policy ecosystems.

By aligning innovation with shared values of safety and transparency, the international community can better balance the transformative benefits of biotechnology with the imperative to protect against rare but devastating biological threats.

The Global Biosecurity Treaty Framework

The global biosecurity treaty framework is a loosely connected set of international agreements, norms, and institutions designed to prevent the misuse of biological agents, reduce biological risks, and coordinate responses to serious biological threats. Unlike nuclear or chemical governance, this framework is fragmented, under-resourced, and largely non-enforceable, reflecting both the dual-use nature of biology and the difficulty of verification.

Despite multiple international agreements on biosecurity, many of the most consequential biological risks are only partially addressed or remain entirely ungoverned at the treaty level. This gap arises because current instruments were designed for intentional state misuse or routine public health threats, not for rare, systemic, and technologically mediated risks.

As a consequence, low-probability, high-consequence (LPHC) biological risks frequently fall outside existing international treaty frameworks. The Biological Weapons Convention (BWC), for example, establishes a strong norm against the hostile use of biology but does not meaningfully address accidental releases, institutional failures, or high-risk research conducted for ostensibly peaceful purposes. As a result, catastrophic biological harm can plausibly arise without any treaty violation, leaving the international system poorly positioned to prevent or detect such risks before they materialize.

One major gap lies in the governance of accidental and dual-use risks. Existing treaties do not impose binding international standards for biosafety, laboratory oversight, or risk-benefit assessment of research that could plausibly generate catastrophic outcomes. While national regulations exist, they vary widely, and there is no global mechanism to ensure that activities with transboundary consequences meet a shared threshold of safety and precaution. For example, the WHO International Health Regulations (IHR) focus on outbreak detection and response, but they do not address upstream risk creation or mandate preparedness for extreme, system-overwhelming scenarios.

Self-propagating biological technologies, such as gene drives and other mobile genetic elements, further expose treaty blind spots. Environmental agreements offer partial oversight, but they were not designed to manage irreversible, large-scale biological interventions with global ecological or public health implications. There is no clear international framework governing intentional releases of biological systems that can spread autonomously across borders, even when such interventions are justified as beneficial. This creates governance ambiguity precisely where potential harms are hardest to reverse.

Verification and transparency gaps compound these problems. The absence of inspection or auditing mechanisms under the Biological Weapons Convention means that high-risk capabilities can accumulate invisibly, whether through advanced research programs, weak biosafety practices, or rapid technological diffusion. At the same time, treaties have limited capacity to adapt to accelerating biotechnology innovation, leaving governance reactive rather than anticipatory. Furthermore, high-risk biological research is often conducted by non-state actors, such as corporations or even by individuals, which makes surveillance very difficult.

Finally, existing agreements largely ignore the second-order effects, including economic disruption, political instability, and erosion of trust, that drive much of the damage in low-probability, high-consequence biological events. Taken together, these gaps mean that the most severe biological risks facing the international community are often neither illegal, nor monitored, nor systematically managed under current treaty arrangements.

Examples of how Low-probability, High-consequence Biological Risks Fall Outside Existing Treaties

1. Accidental Catastrophic Events Are Largely Unaddressed

The Biological Weapons Convention (BWC) focuses on prohibiting deliberate hostile use of biological agents. It does not explicitly address accidental releases, laboratory failures, or institutional errors that could produce comparable global harm. While biosafety is implicitly relevant, there are no binding international standards, inspection mechanisms, or reporting obligations for high-containment laboratories or risky research practices.

As a result, the governance of accidental low-probability, high-consequence events is left almost entirely to national discretion, creating uneven safety standards and blind spots in global risk awareness.

2. Dual-Use Research With Catastrophic Potential Falls Between Regimes

Research that has legitimate scientific or public health objectives but also carries plausible catastrophic downside risks, such as certain pathogen enhancement studies, sits in a governance gap. The Biological Weapons Convention discourages misuse but does not regulate research design, risk–benefit thresholds, or alternative safer methodologies. The International Health Regulations (IHR) focus on outbreak response, not upstream risk creation.

This leaves no treaty-level mechanism to assess whether the global risks introduced by certain research activities outweigh their scientific benefits.

3. Self-Propagating Biological Technologies Lack Clear Oversight

Technologies such as gene drives and other mobile genetic elements, which can spread through populations and ecosystems, pose transboundary risks that may be irreversible. Existing environmental treaties (e.g., the Convention on Biological Diversity and Cartagena Protocol) provide partial coverage but were not designed with catastrophic ecological or biosecurity tail risks in mind.

There is no global treaty that clearly governs the intentional release of self-propagating biological systems with global ecological or health implications, especially when such releases are framed as public health or environmental interventions.

4. Preparedness for Worst-Case Scenarios Is Not Mandated

The WHO International Health Regulations require baseline public health capacities, but they do not mandate preparedness for extreme, system-overwhelming biological events. There are no treaty obligations to:

• Stress-test health systems for catastrophic scenarios

• Maintain surge capacity for rare but massive outbreaks

• Coordinate internationally for worst-case response planning risks; therefore, remain under-prioritized relative to more frequent, moderate events.

5. Verification and Enforcement Gaps Enable Hidden Risk Accumulation

The absence of verification mechanisms under the BWC means there is no systematic way to detect or deter risky biological activities that could generate catastrophic harm, whether intentional or accidental. This includes:

• Undisclosed high-risk research programs

• Weak biosafety practices in sensitive facilities

• Capability accumulation without proportional oversight

Low-probability, high-consequence risks accumulate silently until failure occurs, at which point response options are limited.

6. Governance of Rapid Technological Change Is Fragmented

Treaties evolve slowly, while biotechnology advances quickly. Emerging risks associated with automation, data-driven biology, and decentralized innovation span multiple domains (health, security, trade, and research ethics) without a single coordinating authority.

No existing treaty is tasked with continuous horizon scanning for catastrophic biological risk, leaving governance perpetually reactive.

7. Secondary and Tertiary Impacts Are Not Covered

Current treaties largely ignore the second-order consequences that drive much of the harm in low-probability, high-consequence events, including:

• Economic collapse and supply-chain disruption

• Political instability and conflict

• Misinformation and loss of public trust

These impacts shape outcomes but sit outside the mandates of biosecurity and public health treaties.

General Character and Limitations of the Current Global Biosecurity Treaty Framework

Taken together, the global biosecurity treaty framework is:

• Normatively strong in prohibiting biological weapons

• Operationally weak in verification, enforcement, and risk governance

• Fragmented across security, health, trade, and research domains

• Reactive, with limited capacity to proactively manage low-probability, high-consequence risks

The current framework was largely designed for state-based weapons programs, not for a world of rapidly advancing biotechnology, widespread scientific capacity, and systemic biological risks that can arise without malicious intent. This existing structure is now obsolete and will require major revisions to address current and foreseeable future risks.

Global Biosecurity Treaty Framework, Bottom Line

The current global biosecurity treaty framework provides an essential moral and legal foundation against biological weapons, but does not function as a comprehensive system for managing catastrophic biological risk. Strengthening it will require expanding its focus beyond prohibition toward prevention, preparedness, transparency, and collective risk governance, while preserving its core norm against the hostile use of biology.

Low-probability, high-consequence biological risks often arise not from treaty violations, but from treaty blind spots. Existing agreements prohibit hostile use and support routine public health response, but they leave ungoverned the rare, systemic risks created by powerful technologies, institutional failure, and global interdependence.

Addressing these gaps will require expanding the international biosecurity framework from a rules-based prohibition system into a continuous, collective risk-management regime focused on catastrophic outcomes rather than narrow definitions of compliance.

Conclusion

In conclusion, this analysis underscores that low-probability, high-consequence biological risks pose a fundamental challenge to the existing global biosecurity treaty framework, not because they violate its core norms, but because they frequently fall outside its scope.

Current treaties were crafted for an earlier era focused on deliberate state misuse and routine public health threats, leaving critical gaps in the governance of accidental releases, dual-use research, self-propagating biological technologies, and preparedness for worst-case scenarios. As biotechnology advances and biological risks become increasingly systemic, transboundary, and difficult to reverse, these gaps create conditions in which catastrophic harm can emerge without triggering legal breaches or early warning mechanisms.

Addressing low-probability, high-consequence risks, therefore, requires a shift from reactive, prohibition-centered governance toward proactive, anticipatory, and collective risk management; one that embeds precaution, transparency, verification, and resilience into international institutions.

Strengthening the global biosecurity framework in this way is essential not only to preserve its foundational norm against the hostile use of biology, but also to ensure that it remains fit for purpose in a world where the greatest biological dangers may arise from treaty blind spots rather than treaty violations.

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