ABSTRACT

Following the 2001 end to negotiations on a legally binding protocol, states parties to the 1972 Biological and Toxin Weapons Convention (BWC) developed entrenched positions about the necessity of treaty verification, hindering progress on treaty aims. The study described in this article was designed to facilitate dialogue on verification-related issues outside the context of those positions, using the term “assurance” to represent the degree of certainty that states parties are meeting their treaty obligations. From August 2020 to July 2021, the researchers conducted 36 interviews—16 with state-party delegations and 20 with independent experts, representing 20 countries. They performed mixed-methods analysis on the interviews, including quantitative metrics on qualitative interview content. Interviewees’ views on verification, compliance, and related concepts varied widely. Future efforts by states parties to achieve common understanding on these topics could facilitate concrete progress. While no single mechanism is sufficient to achieve verification or assess compliance, packages of mechanisms could increase assurance. Interviewees expressed general support for implementing assurance mechanisms, even in the absence of a comprehensive, legally binding protocol or verification regime, even among states parties for which that is the primary goal. Avenues to increase assurance among BWC stakeholders merit further discussion in the current intersessional program.

Introduction

When the 1972 Biological and Toxin Weapons Convention (BWC) entered into force in 1975, it became the first multilateral disarmament treaty to prohibit an entire class of weapons.Footnote1 As such, it served as an example for subsequent WMD arms control, disarmament, and nonproliferation treaties, but it stands out due to the absence of an implementation framework or a system to verify compliance with treaty obligations. Other nonproliferation treaties (for example, the 1993 Chemical Weapons Convention and the 1968 Treaty on the Non-Proliferation of Nuclear Weapons) have established systems and activities to implement treaty provisions and verify compliance.Footnote2 BWC states parties pursued efforts for years to strengthen the treaty through some kind of compliance mechanism, but formal efforts to identify appropriate mechanisms, frameworks, and capacities stalled in 2001. Since that time, many states parties have repeated calls for such a protocol, but in the absence of consensus support, no concrete progress has been made toward a comprehensive implementation and verification system or many other treaty aims.Footnote3

At the Third BWC Review Conference (1991), states parties agreed to convene a formal group of governmental experts to identify prospective mechanisms for verification and compliance assessment (VEREX).Footnote4 States parties held a special conference in 1994 and, based on the VEREX findings, established “an Ad Hoc Group, open to all States Parties,” for the purpose of conducting formal negotiations on a legally binding treaty protocol, including a verification regime.Footnote5 The Ad Hoc Group met from 1995 until 2001, when the United States withdrew its support over concerns regarding the feasibility of such a protocol.Footnote6

Discussions that consider the possibility of establishing a legally binding BWC protocol and a verification regime often do not clearly distinguish between these two concepts. While these concepts are closely related, they are not entirely interchangeable. States parties often address these ideas using descriptions along the lines of “a comprehensive, legally binding protocol, including verification,” although the exact phrasing varies.Footnote7 Verification mechanisms would almost certainly be part of any legally binding treaty protocol; however, such a protocol would also include other components, such as an organizational support structure, reporting requirements, mechanisms to monitor advancements in science and technology, and a slate of other mandatory activities. The term “verification protocol” is sometimes used as shorthand to address these concepts collectively, despite the scope of a treaty protocol extending beyond just verification.

The research described in this article originated with the observation that state-party officials and other BWC experts use similar terms but often with different meanings; this is particularly true for “verification.” For example, at a side event hosted by the United States at the 2018 BWC Meetings of Experts on the feasibility of BWC verification,Footnote8 panelists presented the US position that the nature of biological research made it impossible to provide evidence that all biological activities in a country comply with BWC obligations or, alternatively, impossible to identify and inspect all ongoing biological activities to assess their compliance. In contrast, many states parties and experts contend that verification serves to provide greater transparency and certainty regarding states parties’ biological activities rather than definitive proof of compliance.Footnote9 Other common terms with multiple interpretations include “confidence,” which is often associated with BWC confidence-building measures (CBMs), and “strengthen,” which is used frequently but inconsistently in the context of improving the BWC. This study aimed to bring clarity to BWC discussions on these complex issues and support efforts to increase certainty regarding states parties’ biological activities.

Assurance

Following the collapse in 2001 of the Ad Hoc Group and the negotiations on a BWC treaty protocol, the issue of verification became even more contentious and politically charged. States parties developed entrenched positions regarding a legally binding treaty protocol and verification, with the majority expressing explicit support and the United States largely standing alone in public opposition. The practical and political connotations associated with the term “verification” and its narrow but varying definitions make it difficult to hold substantive debate on issues related to BWC compliance. With these issues in mind, the authors designed the study with two principal aims. The first was to examine how states parties and other stakeholders understand verification and related concepts. While it was highly unlikely that the study would identify consensus definitions, documenting the diversity of perspectives on these important and complex topics could shed light on barriers to constructive debate. The second aim was to identify mechanisms, including activities and information, that could provide increased certainty regarding states parties’ adherence to their BWC obligations, particularly those that merit further debate in the intersessional program (ISP) following the Ninth BWC Review Conference (2022).Footnote10

The researchers selected the term “assurance” as the basis for this study to frame the discussions outside the narrow context of contentious terms such as “verification” and “confidence.” This is not the first use of the term,Footnote11 but assurance has not historically been a major topic in BWC discussions. By focusing on a relatively uncommon term, this study endeavored to facilitate constructive dialogue on verification-related concepts without limiting the conversations to specific definitions or connotations. To encourage broad discussion of these concepts and mitigate the risk of becoming mired in challenges similar to those that arise from terms such as “verification” and “confidence,” the researchers did not assign an explicit definition to “assurance.” Rather, they described it broadly as the degree of certainty that states parties are acting in accordance with their BWC obligations. In addition to assurance-related concepts, the study addressed mechanisms that could increase that degree of certainty. Framing the conversations outside the context of a comprehensive, legally binding protocol or verification regime helped maintain focus on the relative merits and limitations of—and the degree of support for—the mechanisms themselves. The researchers also raised the possibility of implementing assurance mechanisms outside of a comprehensive verification system to gauge interest in an incremental approach to assurance.Footnote12

Notably, after participating in interviews for the study, both the United States and Russia included the term “assurance” in their national statements during the 2020 BWC Meeting of States Parties.Footnote13 The degree to which the interviews with representatives from these delegations influenced their use of this term is unclear; however, its inclusion in a national statement or working paper by two of the three BWC depository states for the first time since at least the Eighth Review Conference (2016) is noteworthy and could signal interest in alternative means to increasing certainty regarding states parties’ compliance. In this context, dialogue on assurance is intended to occur in parallel with, not as a substitute for, debate on a legally binding protocol, verification, and related concepts. The Ninth Review Conference afforded states parties the opportunity to define the scope of formal debate on BWC issues for the next five years.

This article presents findings that address the diversity in how verification, compliance, and related concepts are understood in the context of the BWC. It also highlights prospective assurance mechanisms that merit further debate, which can provide valuable insights as states parties prepare for the 2023-26 ISP.

Methodology

Interviews

From August 2020 to July 2021, the researchers conducted a series of 36 semi-structured, virtual interviews with key informantsFootnote14 representing a variety of perspectives on the BWC, including individuals affiliated with BWC delegations and independent experts. The latter category included individuals affiliated with academic institutions and other civil-society organizations; the BWC Implementation Support Unit (ISU) and other nonproliferation organizations, such as the Organisation for the Prohibition of Chemical Weapons (OPCW); and former BWC delegation members who provided their individual perspectives. The researchers identified prospective interviewees based on relevant expertise and institutional affiliations, including participation in BWC and other nonproliferation meetings, utilizing purposive sampling with a view to including diverse geographic, political, and demographic perspectives.

The researchers developed the interview guide (see box) based on results of an informal literature review, including historical accounts of the BWC protocol negotiations and research and commentary on BWC verification and other WMD nonproliferation regimes, as well as the researchers’ personal experience related to BWC proceedings, statements, and debate. The first portion of each interview focused on definitions of five key concepts under the umbrella of assurance—"verification,” “compliance,” “confidence,” “monitoring,” and “strengthen”—asking the interviewees how they define or understand these terms in the context of the BWC. Focusing on these terms enabled the researchers to characterize how stakeholders approach these issues and provided a foundation for the remaining questions. The second half of the interview focused on how to increase assurance, including specific assurance mechanisms; historical changes and trends in the BWC, including technological advancements and geopolitical shifts; and the relationship between BWC verification and other nonproliferation regimes. While the interview guide included core questions and topics, interviewees were allowed to direct the conversation based on their individual experiences and priorities. All interviews were conducted on a not-for-attribution basis to promote candor and transparency. Multiple members of the research team took detailed notes during each interview, and audio was recorded—with interviewees’ consent—to supplement interview notes.

Semi-structured interview guide

The semi-structured interview guide reproduced below was developed to include priority topics identified through an informal literature review, such as analysis of the BWC protocol negotiations and commentary on BWC verification-related issues, and the research team's personal experience with BWC meetings, statements, and debate. Part I addresses the definitions of terms under the umbrella of assurance; Parts II and III address assurance-related mechanisms; Part IV addresses the value of assurance; and Part V addresses lessons that can be drawn from other nonproliferation regimes. All five terms in Part I were covered in each interview. All five parts were included in each interview, but the exact topics addressed under Parts II–V varied, to allow each interviewee to discuss her/his priorities and perspectives. Not all topics were addressed in every interview.

  1. How do you define and approach the following concepts and terms related to assurance in the context of the BWC?

    1. Verification

    2. Compliance

    3. Confidence

    4. Monitoring

    5. Strengthen or strengthening

  2. What mechanisms, including activities and information, would increase your assurance that states parties are adhering to their obligations under the BWC?

    1. Are there specific mechanisms that would apply to specific BWC articles?

    2. Are there particular mechanisms that you or your country would simply oppose or that would be impossible to implement?

    3. Are there mechanisms that you would agree to in principle but that are not practically or technically feasible?

    4. Are there mechanisms discussed during the BWC protocol negotiations that would be substantially different if debated today? Or have scientific advances made some mechanisms that were previously not possible more feasible to implement today?

    5. Are there any mechanisms used for chemical or nuclear weapons verification that you believe would be beneficial for the BWC? Or are there any that are not possible for the BWC?

  3. Would you have any stipulations, limitations, reservations, or other requirements for implementing any of these mechanisms or for gathering or providing this kind of information?

  4. What do you think is the value of assurance? What is the value of having certainty that states parties are adhering to their BWC obligations?

  5. Are there any changes over the past 20–30 years that would make implementing assurance mechanisms either easier or more difficult today? For example:

    1. New technical developments and capabilities

    2. Political barriers

    3. The priority placed on the concept of verification or assurance in BWC discussions or activities

    4. The expanding range or scope of threats, including biological agents and actors

Mixed-methods analysis

The researchers employed a mixed-methods approach to analyze interview content, systematically and rigorously documenting the landscape of perceptions associated with BWC assurance—and related concepts—and assurance mechanisms. The analysis included three stages: qualitative coding of interview notes using NVivo qualitative coding software (Release 1.5.1), quantitative analysis to identify priority topics, and targeted thematic analysis of coded interview notes. While the researchers used quantitative analysis to identify priority themes, they did not design the methodology to yield quantitative results, such as the prevalence of specific perspectives among BWC delegations or independent experts.

Codebook development and thematic coding

The research team developed the initial thematic coding framework during the second half of the interview process. Team members collaboratively added themes based on topics discussed during previous interviews, and other themes were added as they emerged in the remaining interviews. At the end of the interview process, the researchers collectively reviewed interview notes to identify remaining themes and organized the themes into a hierarchy to facilitate coding efforts.

All notes from a given interview were assigned to a single coder, and interviews were distributed evenly among the coding team. Three team members conducted all coding. The coders piloted the coding framework on a subset of interviews and reviewed the results to add, edit, and reorganize codes in the final framework (Appendix 1) before conducting the final coding on all interviews. As new themes emerged during the coding process, new codes were added to the framework, and the coders reviewed completed interviews using the new codes. The final coding framework included higher-level, topic-focused categories such as terminology and definitions; data collection, reporting, analysis, and sharing; site visits and expertise engagement; national implementation; BWC articles; dialogue and diplomacy; funding; actors; real-world examples; and historical changes. Additional categories—including qualifiers, feasibility, sentiment, and motivations or outcomes—helped document perceptions related to other topics. Each interview was also classified by interviewee type (that is, “state party” or “independent expert”). At least one team member reviewed all coding for quality control, and the coders discussed and resolved coding discrepancies and concerns by consensus. The text of interview notes could be assigned multiple codes (that is, co-coded reference), which provided the opportunity to identify potential associations between those codes.

Quantitative metrics

Quantitative data helped identify priorities for the final thematic analysis. Using NVivo 12 Pro and Microsoft Excel, quantitative metrics were generated for all codes in the framework to measure the frequency with which they were discussed. These metrics included the number of coding references (that is, individual chunks of coded text) corresponding to each code and the number of interviews in which each code was discussed, and quantitative metrics were generated for both individual codes and co-coded pairs (that is, two codes assigned to the same text). Group-specific metrics for state-party and independent-expert interviews were also generated to identify themes discussed more often in one group than the other, which could signal differences in how independent experts and states parties prioritize certain topics. To account for different numbers of state-party and independent-expert interviews, the metrics were weighted inversely by the relative proportion of interviews in each group. Priority themes identified through quantitative analysis included individual codes and co-coded pairs present in at least 10 interviews and those with a difference in weighted interview frequency of five or greater between states parties and independent experts.

Qualitative analysis

For the final thematic analysis, the researchers conducted a detailed review of the coded text corresponding to priority codes. Priority codes included those identified through quantitative analysis as well as a subset identified a priori related to topics of interest during past BWC-related meetings and literature, based on the researchers’ expertise and observations, and statements that stood out during the interviews. This a priori list of themes enabled the researchers to identify important comments that were not prevalent across numerous interviews.

The Johns Hopkins University Bloomberg School of Public Health Institutional Review Board determined that this study did not constitute human-subjects research (IRB00011207).

Findings

Interviews and quantitative analysis

The researchers conducted a total of 36 interviews—16 with individuals who work on or with BWC delegations (states parties) and 20 with independent experts (). The interviewees represented 20 countries across six continents as well as all three BWC regional groups (). One interviewee invited to represent a state party elected to participate in her/his individual capacity, but s/he was able to provide insight into how that delegation thinks about these important topics. One independent expert requested not to be listed as a participant, and one state party declined to be recorded. To promote geographic and political diversity, invitations were sent to more than 90 e-mail addresses, corresponding to individuals and diplomatic missions in more than 30 countries as well as multiple UN offices. The researchers performed thematic coding on 93 sets of interview notes, resulting in 10,307 total coding references (Appendix 1) and 23,819 co-coded references (Appendix 2). Of the 219 codes in the final coding framework, 134 were addressed in at least 10 interviews, as well as 109 co-coded pairs.

Figure 1. Participant map. Created with mapchart.net: https://www.mapchart.net/terms.html#licensing-maps. Creative Commons Attribution-ShareAlike 4.0 International License: https://creativecommons.org/licenses/by-sa/4.0/.

Figure 1. Participant map. Created with mapchart.net: https://www.mapchart.net/terms.html#licensing-maps. Creative Commons Attribution-ShareAlike 4.0 International License: https://creativecommons.org/licenses/by-sa/4.0/.

Table 1. Study participants

While the study was not designed to yield quantitative results, the findings below attempt to reflect the relative frequency with which interviewees discussed certain topics or expressed certain viewpoints (for example, “some” or “multiple” interviewees). These statements reflect only the content of the interviews and are not necessarily representative of BWC states parties or the broader BWC community.

Terminology

The first portion of the interviews focused on understanding how stakeholders define and approach core concepts under the umbrella of “assurance.” Interviewees expressed a broad range of views on these terms, without consensus emerging around particular definitions. At times, their definitions and understandings of different terms (for example, “verification” and “compliance”) overlapped considerably, which illustrates the absence of clear distinctions between these core BWC concepts.

Verification

Verification” elicited the most diverse perspectives, some in direct conflict with one another, without any clear definition or understanding of this term. Interestingly, one state party indicated that “verification” is already an established term, with the definition set during the BWC protocol negotiations, whereas others argued that there is no consensus or that the definition has evolved over time. One state party explicitly discussed how some BWC delegations use the ambiguity around verification to deliberately stoke confusion or antagonize other delegations. S/he argued that a common understanding would be beneficial in BWC discussions. States parties and independent experts both described a myriad of approaches to the concept of verification, dealing with its purpose, scope, feasibility, and associated activities.

For some interviewees, verification would need to provide concrete evidence that no nefarious activities are taking place, similar to other nonproliferation treaties. These interviewees acknowledged, however, that it is not technically feasible to achieve this standard for biology. Others perceived the value of verification in terms of increasing transparency and confidence, which necessitates a higher degree of uncertainty than with concrete evidence but enables formal implementation of mechanisms that are not currently part of the BWC. Numerous interviewees discussed how the widespread and expanding availability and accessibility of biological equipment, technology, supplies, and pathogens, coupled with biological organisms’ ability to replicate, make it impractical to apply “material accountancy” approaches used for other nonproliferation treaties to BWC verification.Footnote15 Further, the “dual-use nature” of biology makes it difficult to distinguish between appropriate and nefarious activities. In fact, one interviewee commented that verification would be a straightforward process if this delineation were clearer. Without practicable options to concretely assess biological activities, there will always be a relatively high degree of uncertainty, and several interviewees indicated that the acceptable degree of uncertainty for BWC verification remains a point of contention.

Interviewees also disagreed regarding the scope of verification, including what exactly would be verified. One of the more straightforward approaches described involved verifying the accuracy of states parties’ declarations, including on facilities, equipment, activities, or pathogens present or in use, as under some other nonproliferation treaties. More commonly, however, interviewees described verification as applying to assessments of states parties’ compliance with their BWC obligations. In fact, one state-party interviewee commented that compliance assessment is impossible without a means of verification, illustrating that some view the two concepts as inextricably linked. But even within the scope of compliance assessment, interviewees differed on how the concept applies to various treaty obligations. Some focused on BWC prohibitions—or negative obligations—such as those in Articles I–III, while others included positive obligations as well, such as national implementation under Article IV,Footnote16 international support under Articles VII and X, and required reporting or declarations. Some interviewees also discussed “internal verification” in the context of states parties assessing their own compliance, as a way to ensure the effectiveness of national implementation efforts. These interviewees generally took a broader view of verification, encompassing all treaty provisions—that is, not just the nonproliferation obligations. Beyond compliance assessment, some interviewees discussed additional benefits of verification, such as deterrence value, as verification activities would increase the difficulty of concealing prohibited activities, or support for investigations of suspected violations of the BWC, including microbial forensics or attribution for suspected deliberate biological events.

Several interviewees discussed verification as a process, as opposed to an endpoint, referring to a series of ongoing, long-term measures to maintain and assess compliance, rather than a goal states parties can achieve. They emphasized the need for a continual cycle of information sharing and follow-up to provide updated assessments regarding ongoing activities and emerging capabilities. Such a process would require a systematic approach, including defined structures and standards for collecting data, conducting analyses, and interpreting results or determining compliance. Notably, several interviewees indicated that interpreting results and drawing conclusions are inherently political processes, which further complicates compliance-assessment efforts.

While questions remain regarding verification, the concept remains important for many stakeholders, including many states parties. Numerous state-party interviewees indicated that implementing a verification regime as part of a legally binding treaty protocol is one of their highest priorities. For them, verification is a core component of the BWC, and arms-control treaties more broadly. One state party argued that verification is necessary to address compliance in a legal sense.

Compliance

The most common description of compliance was in the context of adhering to treaty obligations, but as with verification, there was considerable variation in the scope of how interviewees viewed those obligations. Obligations ranged from those explicitly outlined in the treaty text to consensus and politically binding agreements among states parties (for example, at review conferences) to the more nebulous “spirit of the treaty,” which broadly encompasses the norm against biological weapons. Some interviewees also indicated that there is a subtle difference between a state party operating in compliance with the treaty and being assessed as in compliance, which reflects a distinction between actions or self-assessment on the one hand and external assessments on the other.

The most substantial discussion in the context of compliance addressed how interviewees prioritized various treaty obligations, or alternatively, the distinction between noncompliance and treaty violations. The interviewees noted that states parties inherently prioritize different aspects of the treaty. Some viewed BWC prohibitions (for example, under Articles I–III) as the core of the treaty, seeing a failure to comply with these obligations as a violation or breach of the treaty. In contrast, failure to comply with any provision, including positive obligations (for example, under Articles IV, VII, and X), would be considered noncompliance. Essentially, they viewed treaty violations or breaches as a more egregious subset of noncompliance. Some of them also discussed a third class, technical noncompliance, that covers inadvertent noncompliance or minor aspects of the treaty (such as late reporting or a failure to pay assessed dues on time). While these interviewees emphasized nonproliferation as the core of the treaty and prioritized prohibitions for verification, they also acknowledged that all obligations are important. Conversely, others applied compliance to the treaty as a whole, placing similar importance on all BWC provisions without distinguishing between noncompliance and violation.

Confidence

Interviewees discussed confidence in less specific terms than verification and compliance. For many, confidence was closer to a feeling or perception than a clearly defined standard or process. Interviewees most often discussed it in the context of states parties’ compliance with their BWC obligations, but also in the context of the BWC's ability to fulfill its intended purpose and reinforce the norm against biological weapons. Many factors contributed to the sense of confidence, including how responsibly the states parties operate within the BWC and in other international forums. Confidence generally included a degree of trust, but for some interviewees, trust must be accompanied by supporting data or a concrete demonstration in order to yield confidence. In this sense, confidence derived not only from a state party's desire to meet its treaty obligations, but also its capacity to do so. One state party emphasized that trust needs to be grounded in evidence.

Whereas trust and evidence support confidence, uncertainty and ambiguity drive mistrust and decreased confidence. Multiple interviewees emphasized that information sharing and transparency can provide both objective evidence and increased trust, which contribute to enhanced confidence, but when states parties withdraw from cooperative activities, it has the opposite effect. Interviewees often discussed confidence in the context of CBMs, which, not surprisingly, aim to build confidence regarding states parties’ biological programs and activities; however, many officials and independent experts said that low participation and concerns about report accuracy limited the value of CBMs. Interviewees argued that ambiguity and decreased transparency breed mistrust and concern, which not only affect confidence, but can also bleed into other aspects of BWC engagement or other international forums. Several interviewees cited this as a major concern in the BWC and a potential roadblock to concrete progress on priority topics.

Monitoring

While there was no consensus on the format or scope, interviewees largely described monitoring as an information-gathering process, typically in the context of states parties’ biological activities. Generally, they discussed monitoring as a continual or sustained process, as opposed to one-time events, and indicated that monitoring can take a variety of forms, including formal, structured processes, such as those discussed by VEREX or the Ad Hoc Group or analogous mechanisms under other nonproliferation treaties.Footnote17 Several interviewees lamented, however, that the BWC has neither the authority nor the capacity to conduct formal monitoring activities. Monitoring can also be implemented on an informal basis, including by states parties or civil-society organizations. Interviewees described active or passive monitoring efforts, depending on the degree of effort required to obtain information. Active measures include inspections, site visits, or interviews, whereas passive monitoring could occur via review of reports (such as those associated with CBMs), declarations, or other available data. Monitoring activities carried out by civil-society organizations are often limited to open-source data. Independent experts emphasized civil society's role in monitoring and accountability, while states parties focused more on civil society's ability to support the BWC (for example, through technical expertise, education, and outreach). Publicly available data on exports, imports, purchases, and shipping could support civil-society monitoring. Despite the availability of open-source data, it is difficult to definitively determine activities or intent based on these data alone; one interviewee noted that proprietary processes can make it difficult to interpret these data. Some interviewees discussed monitoring in the context of advancements in science and technology and their potential impact on the BWC, again highlighting that the internal capacity to conduct these activities does not currently exist under the BWC. Multiple interviewees also discussed disease surveillance in the context of monitoring, particularly as a mechanism to identify emerging outbreaks or other events.

Strengthen

Many interviewees struggled to define “strengthen” in the context of the BWC. They noted that it is used pervasively in BWC statements and discussions, but it can apply to a variety of contexts. It generally refers to some form of improvement, but it can address many topics, including the BWC treaty text or implementation, the ISU and institutional capacity, national implementation, or the broader norm against biological weapons. Several interviewees explicitly associated “strengthen” with the Ad Hoc Group's mandate and noted that it can serve as coded language to refer to verification.Footnote18 Multiple interviewees emphasized the importance of ensuring that the BWC remains nimble, resilient, and relevant in the face of emerging capabilities and threats. Some commented that the COVID-19 pandemic highlights the potential severity of biological threats and called on states parties to leverage the current attention on large-scale biological risks to stimulate necessary updates to the BWC and its implementation at the national and global levels. One independent expert emphasized that states parties have a short window of opportunity, perhaps 6–18 months, to make lasting change before attention wanes.

Assurance mechanisms

The majority of interviewees, both states parties and independent experts, expressed support for the concept of assurance and identified various ways in which it could provide value to the BWC, including by increasing transparency and mitigating uncertainty or ambiguity regarding states parties’ biological activities. They acknowledged that assurance could build trust and confidence that states parties were abiding by their treaty obligations, which would support states parties’ efforts to realize the full benefits of biology for peaceful purposes. Even one state party that opposed assurance—in part, because it cannot substitute for verification—acknowledged that it would contribute to increased predictability and decreased tensions between states parties. Providing a substitute for verification was not the researchers’ intended purpose for BWC assurance, but this example illustrates its value to a broad scope of stakeholders.

Interviewees discussed a broad scope of mechanisms they felt could increase assurance in BWC-related activities. Again, there was no consensus on any particular mechanism, in part due to the diverse array of options presented over the past several decades. Multiple interviewees underscored that there are no new ideas in the context of BWC verification, compliance assessment, and related concepts. Rather, new strategies to address BWC compliance are essentially exhausted, and current proposals are iterations of previous strategies. In fact, one interviewee asserted that if states parties could somehow combine all past proposals, the BWC would be perfect.

Interest in specific mechanisms and proposals varied, although some implementation details and goals did attract broader support across interviewees. Numerous interviewees indicated that a package or combination of mechanisms is superior to any single mechanism in terms of increasing trust, transparency, and assurance. One interviewee even argued that “hundreds of mechanisms” were potentially needed to address various aspects of the treaty. Despite the preference for a combination of measures, several interviewees did note that an incremental approach to implementing assurance mechanisms is better than a stalemate in negotiations on a comprehensive package. Notably, this opinion was shared even among interviewees who ultimately desired a comprehensive, legally binding protocol.

Multiple interviewees argued that multilateral approaches are preferable to unilateral or bilateral efforts. They argued that the value of multilateral activities increases with greater participation due to the need for standardization and reciprocal obligations among participating states parties. Some maintained that while consensus agreement and universal participation would be ideal, they are not necessary for assurance activities to have merit, and mechanisms with limited participation could still provide benefit in terms of increasing transparency and mitigating uncertainty. One independent expert noted that other nonproliferation efforts involving smaller groups of countries can stimulate change in a difficult global geopolitical climate. Humanitarian disarmament efforts (for example, the Anti-Personnel Mine Ban Convention,Footnote19 the Convention on Cluster Munitions,Footnote20 and regional nuclear-weapon-free zonesFootnote21) illustrate how countries can tackle disarmament issues important to them, independent of the interests or actions of more powerful countries or global consensus or participation. S/he emphasized that the collective, organized activities of a few countries can create pressure on others to follow suit and generate opportunities for implementing new ideas that would not achieve consensus in larger forums and that similar principles could apply for assurance mechanisms.

Interviewees also discussed several mechanisms that are already formal components of the BWC. Numerous interviewees prioritized international scientific information exchange and engagement with national technical experts to improve assurance, and Article X obligates states parties to support capacity-building and information-sharing efforts internationally. Several interviewees emphasized the importance of establishing and maintaining biosafety and biosecurity capacities to mitigate the risk of accidental or deliberate biological incidents, including through programs supported by states parties with well-developed biology and biotechnology sectors to share best practices via training and engagement. Additionally, capacity-building efforts to improve preparedness and response systems, including for deliberate events, could disincentivize the use of biological weapons by making it clear that they would not achieve their objective—termed “deterrence by denial.” States parties discussed Article X support for national implementation more frequently than independent experts did, often focusing on support for developing and improving legislation and establishing effective oversight and regulatory systems. One state party argued that support for improving national implementation was more valuable than inspecting or monitoring the current state of national programs and policies.

In terms of expertise engagement and scientific exchange, interviewees supported the BWC meetings of experts as a forum for substantive discussions on relevant technical issues. In the absence of a formal body of experts under the BWC, interviewees viewed these meetings as one of the principal opportunities to introduce technical expertise. Several emphasized that, while the meetings often focused on technical issues, social sciences should not be excluded from such discussions, as they can address complex issues around human factors, including barriers to assessing intent. Interviewees indicated that the COVID-19 pandemic forced the BWC to incorporate mechanisms to support remote participation in meetings and that such participation expands opportunities to engage experts who are unable to attend in person. They noted that eliminating logistical and financial burdens, such as travel and lodging, could facilitate additional technical representation from states parties, including low- and middle-income countries, beyond the pandemic. Several interviewees also expressed interest in increasing participation by industry representatives, including identifying “BWC champions” that support BWC principles across relevant sectors. Independent experts discussed industry representation more frequently than states parties; the states parties tended to focus more on protecting industry interests, including intellectual property, than on facilitating engagement.

Interviewees both expressed support for CBMs as an integral mechanism for increasing transparency within the BWC and noted major limitations. While useful, there are opportunities for improvement. CBMs were designed to increase transparency and facilitate information sharing regarding relevant biological activities, but interviewees highlighted low participation and challenges with CBM report completeness and accuracy as barriers to improving confidence. They called attention to the record CBM participation in 2021—surpassing one-half for the first timeFootnote22—as encouraging, but they emphasized that participation is not the full picture. There was limited discussion of expanding CBM content, perhaps by capturing nongovernmental activities (for example, in the private sector and academic institutions) and government-sponsored work conducted in other countries. Rather, many interviewees focused on the quality of CBM submissions. CBMs are intended to increase confidence in states parties’ activities and programs through increased transparency, but some interviewees argued that incomplete or inaccurate information limits those benefits. Additionally, several interviewees expressed concern that some CBMs could be deliberately misleading, which introduces uncertainty and concern and breeds mistrust. Some interviewees, including states parties, disagreed on the question of whether CBMs—introduced at the Second Review Conference (1986) as “politically binding” measuresFootnote23—qualify as voluntary or mandatory, and several indicated that voluntary CBMs have less value, both in terms of encouraging participation and the quality of report content.

While interviewees generally encouraged participation in submitting CBM reports, some argued that the CBM submissions in and of themselves do not build confidence and that associated efforts to analyze and make use of the data are needed to provide value to states parties. Multiple interviewees, including states parties, lamented that, while participation is increasing slowly, many CBMs remain hidden from public view and called for CBM reports to be published publicly to encourage accuracy and increase transparency. All CBM submissions are available to states parties, but states parties must elect to make their reports available to the public. Several independent experts emphasized that civil society largely draws upon open-source information and that restricted CBM reports impede civil-society efforts to monitor states parties’ activities. Multiple interviewees supported a capacity to analyze CBM content, to both assess accuracy and make use of the data. They acknowledged that many states parties do not have the resources to analyze annual submissions, nor does the ISU. The interviewees argued that without such analysis—which could, for example, identify changes from previous reports or characterize longer-term trends—the information itself has limited value in terms of building confidence. They expressed interest in establishing a formal capacity to analyze CBMs and report to states parties on their content. Interviewees proposed several options, including a formal BWC body—potentially the ISU—or an independent organization. They acknowledged, however, that this capacity would be outside the ISU's current mandate and would require funding and staffing to support. They also acknowledged that an independent organization (for example, from civil society) would require full access to CBM reports, many of which are not publicly available.

Interviewees also prioritized strengthening the BWC's organizational capacity and discussed a myriad of options for doing so. Much of this discussion focused on expanding the ISU, including personnel, resources, and responsibilities. Numerous interviewees, including multiple states parties, expressed a desire for a BWC analogue to the OPCW or the International Atomic Energy Agency (IAEA). Prospective expanded ISU activities included analyzing CBMs, monitoring advances in science and technology, supporting national implementation, and coordinating assurance-related activities. Importantly, these interviewees acknowledged that any additional responsibilities would require funding and a mandate from the states parties. Interviewees emphasized the importance of establishing a BWC-specific capacity to monitor advancements in biology and biotechnology, and some discussed proposals for a scientific review mechanism or board, analogous to the OPCW's Scientific Advisory Board,Footnote24 although there remains considerable debate regarding the scope and format for such an entity. Some interviewees commented that some of these functions could be instituted outside the ISU as well, perhaps through independent bodies established by the states parties or existing international organizations.

Multiple interviewees, including three states parties, discussed expanded use of Article V consultations to address questions regarding states parties’ BWC-related activities and programs. Crucially, Article V explicitly establishes a mechanism that is intended to mitigate ambiguity and concern.Footnote25 The interviewees discussed how Article V consultations could increase transparency and trust and avert larger confrontations by allowing states parties to proactively address specific questions. They also noted that Article V enables states parties to address these concerns within the BWC, serving as a firewall between the BWC and United Nations. One interviewee emphasized that once Article VI—which empowers states parties to “lodge a complaint with the [UN] Security Council” in response to a suspected breach of treaty obligationsFootnote26–is invoked, states parties essentially transfer authority to the Security Council, and few options exist for regaining control. Several interviewees lamented that the Security Council's political environment and power dynamics, including veto authority for permanent members, could limit its effectiveness in investigating suspected breaches. Several interviewees emphasized that historical use of Article V is extremely limited, and its future use would benefit from formalized procedures. Interviewees also indicated that infrequent use has stigmatized the consultations, and there is hesitancy among states parties to invoke Article V because it can seem accusatory. They suggested that more routine use could reduce this stigma and increase transparency to mitigate concerns and foster cooperation among states parties.

Interviewees also expressed interest in assurance mechanisms outside the formal scope of the BWC. In particular, numerous interviewees discussed the value of peer review and voluntary site visits, including descriptions of multiple recent examples. Several discussed their capacity to increase transparency regarding states parties’ activities and foster engagement with technical experts. One interviewee commented that peer review approaches assurance from a holistic perspective by observing how states parties apply national implementation, rather than trying to detect noncompliance. Several interviewees also argued that insight into national implementation can facilitate the dissemination of best practices, helping other states parties adopt more effective policies or practices. While peer review may increase transparency to some degree, several interviewees emphasized that its voluntary nature limits that value. One state party insisted that because host countries have full control of access to facilities, personnel, activities, and information, the assurance that voluntary activities provide is largely illusory. This interviewee emphasized that peer review cannot substitute for compliance assessment or verification.

Interviewees also identified scientific codes of conduct as having made substantial progress since the Eighth Review Conference, and they suggested these codes can provide indirect assurance by supporting the responsible use of science. Specifically, they maintained that codes of conduct complement educational programs, awareness-raising efforts regarding risks, professional and ethical standards, and nonproliferation norms. They also establish practices for identifying and reporting concerning activities. Interviewees commented that these codes can be instituted at the national, organizational, and facility levels, and they establish both top-down and bottom-up frameworks for monitoring biological activities. The associated ethical principles apply broadly to the scientific community, including government researchers, industry, academic institutions, and even public laboratories (for example, do-it-yourself, or DIY, biology). Additionally, model codes of conduct can be adapted for a variety of environments.Footnote27 Interviewees also indicated that principles of responsible research can be incorporated into educational programs to build a sustainable ethical foundation among future generations of scientists and policy makers. They also said that establishing widely accepted ethical principles could increase assurance that biology is being used responsibly and provide frontline monitoring for questionable activities and emerging capabilities.

Beyond existing mechanisms, interviewees also discussed a variety of activities that could be implemented in the future to enhance treaty implementation and increase assurance, including on-site inspections. Several interviewees identified inspections as a core component of many other nonproliferation treaties, largely supporting compliance assessments, but proposals vary widely in how they could be implemented for the BWC. Interviewees discussed options ranging from routine inspections, based on random or quota-based sampling, to challenge inspections for investigating suspected treaty violations, assessing anything from declaration accuracy to compliance of specific activities. Several interviewees stressed that, unlike the OPCW or IAEA, there is no BWC-affiliated entity that possesses the capacity to conduct inspections. States parties would need to establish that capacity, take on that role themselves, or defer to an independent body. Any decision would require consensus on standardized procedures and analyses, potentially including the involvement of internationally accredited reference laboratories. Multiple states parties emphasized that advancements in microbial forensics could facilitate efforts to trace pathogens to their source, potentially providing attribution capacity for investigators, and several highlighted that objective and independent analysis would be especially important for these types of inspections.

Numerous interviewees expressed support for a comprehensive, legally binding protocol that includes verification, and this remained a high priority for many states parties and independent experts. Beyond a formal verification regime, interviewees identified a broad range of activities that could be codified under such a protocol, including procedures for invoking Articles V–VII; on-site inspections, including attribution investigations; and incorporating the UN Secretary-General's Mechanism for Investigation of Alleged Use of Chemical and Biological Weapons (UNSGM), which is currently not a component of the BWC. Multiple interviewees also expressed interest in revisiting protocol negotiations, accounting for geopolitical shifts and technological developments since 2001 that could alleviate previous roadblocks. Some interviewees expressed a preference for restarting discussions from existing protocol texts, such as the 2001 “composite text” or “rolling text,” but others argued that too many technical and political barriers remained and that previous drafts are no longer viable. Regardless of the starting point, numerous interviewees expressed support for revisiting negotiations on a legally binding protocol.

Barriers and facilitators

Individual assurance mechanisms have unique limitations and implementation barriers, particularly in the context of achieving universal participation; however, there are numerous broader, high-level barriers, including technical and political ones, to establishing and implementing assurance-related programs for the BWC. Assurance mechanisms also have their own unique capabilities, and they must be implemented to achieve specific purposes. States parties must determine their goals and select appropriate mechanisms to achieve those aims.

Defining and understanding core BWC concepts, including verification and compliance, remain major barriers, as there is no consensus on how they apply to the BWC. Interviewees generally viewed verification, as applied under other nonproliferation treaties, as largely limited to the context of a comprehensive, legally binding protocol. But interviewees also expressed many uncertainties regarding the scope and purpose of verification under the BWC, as well as its relationship to compliance. Interviewees emphasized that without a legally binding agreement in place, the BWC must rely on alternative mechanisms to reinforce the norm against biological weapons, build trust and certainty regarding states parties’ activities, and assess compliance with treaty obligations. They articulated a variety of perspectives regarding the aspects of the treaty to which compliance and verification apply. Some viewed compliance and verification as applying equally to all treaty obligations. Others, however, viewed verification as applying more directly to treaty prohibitions (such as under Articles I–III) or described varying degrees of noncompliance. In this context, a failure to comply with nonproliferation aspects of the treaty would constitute a more severe degree of noncompliance. There was no consensus around any particular understanding on these fundamental concepts.

Multiple interviewees indicated that the principal barriers to BWC verification are more political than technical. One of the biggest challenges discussed was the inherent tension between national sovereignty and access. Currently, in the absence of a BWC protocol and verification regime, states parties can choose to share information about their biological programs, activities, facilities, and capabilities, but they are not required to do so. If they elect to participate in such voluntary activities, they maintain control of access to facilities, data, and personnel, which limits the extent to which these types of activities provide transparency and certainty regarding treaty compliance. In contrast, a BWC protocol or verification regime would obligate states parties to provide certain information or access to other states parties and, potentially, external auditors. This approach—that is, mandatory participation and adherence to common and established standards and practices—promises a more complete picture of ongoing biological activities. With that in mind, interviewees did acknowledge that, in implementing mandatory activities, states parties would have to relinquish some control to outsiders. Several interviewees argued that a credible verification system must be able to compel states parties’ participation and guarantee access to certain facilities, data, and personnel. One state-party interviewee who supported verification, however, asserted that any activities that encroach on national sovereignty would be unacceptable, highlighting the conflict inherent in mandatory verification activities. Some also noted that similar challenges exist when expanding assurance mechanisms from government programs to the private sector, particularly for multinational companies that fall under the jurisdiction of multiple governments. Several interviewees focused on technical innovation, including the ability to enable remote monitoring, as a potential way to provide access to specific types of information while mitigating the risk to intellectual property, trade secrets, classified intelligence, or other sensitive materials. As with questions of compliance assessment, states parties must determine the appropriate balance and the extent to which they are willing to cede sovereignty to implement mandatory activities, which one interviewee emphasized would be a political decision.

Interviewees indicated that diplomatic conflict and growing mistrust among governments can spill over into BWC-related issues. For example, one interviewee noted that worsening geopolitical tensions are impacting CBMs’ ability to increase confidence, as they contribute to concerns that certain states parties are submitting inaccurate CBM reports. These problems can compound when assessing treaty compliance or the origins of emerging biological events. One interviewee described each step of any assessment, from collecting data to conducting analysis to interpreting findings, as progressively more subjective and political. S/he argued that, even starting with the same objective evidence, political influence could lead states parties to reach very different conclusions regarding the nature of a biological event or the compliance of facilities or activities. Several interviewees cited speculation regarding the origins of the SARS-CoV-2 virus—that is, that the virus escaped laboratory containment or that it was genetically engineered—as an example, emphasizing that the political influence would undoubtedly be even more prominent were an outbreak actually deliberate in origin. Multiple interviewees also described how suspected or documented violations of chemical- and nuclear-weapons treaties can negatively impact the BWC, both in terms of diplomatic tensions and erosion of WMD nonproliferation norms. Additionally, they identified biotechnology as a growing economic driver and stressed that competition between states parties can hinder information sharing, technology transfer, and transparency as governments attempt to protect their investments and relative advantages over other countries.

The dual-use and material-balance challenges for BWC verification are well documented,Footnote28 and other technical barriers remain to implementing assurance mechanisms. Multiple interviewees argued that it could be difficult or impossible to gain insight into all ongoing biological activities in a given country—depending on the scope of these activities—including government-sponsored activities and those in academic, industry, and individual or community laboratories. In particular, multiple interviewees described challenges their respective countries face in terms of engaging the DIY biology community and understanding the breadth of ongoing public biological activities. Some also discussed barriers involving protecting intellectual property and industry trade secrets, particularly in the context of the growing bioeconomy. Additionally, several interviewees emphasized that biological activities’ legitimacy under the BWC hinges on intent (that is, peaceful or nefarious), which could be very difficult to arbitrate during a compliance assessment. One independent expert commented that the contentious geopolitical landscape further complicates assessments of intent due to high degrees of mistrust between governments.

Interviewees also noted that some treaty obligations are less concrete than others, which can make compliance more difficult to evaluate. For example, Article IV obligates states parties to implement the BWC at the national level; however, there are no associated standards for the legislation or the regulatory capacity necessary to do so. Interviewees also identified similar challenges with Articles III, VII, and X, as well as other components of the treaty, including CBMs. Interviewees discussed how some activities undertaken to comply with certain treaty obligations could be viewed as conflicting with others, such as export controls in the context of Articles III and X. There was also uncertainty regarding which party, the assessor or the assessed, would bear the burden of proof for compliance assessments—that is, would states parties need to demonstrate compliance or assessors demonstrate noncompliance? While these technical barriers may have technical solutions, interviewees acknowledged that political negotiations necessary to establish boundaries on assurance-related activities could mitigate their impact.

Nevertheless, there are factors supporting efforts to implement BWC assurance mechanisms, and interviewees expressed broad interest in making progress in this area, whether their end goal was a comprehensive verification regime or increased transparency and trust. States parties and other stakeholders continue to submit and debate proposals, and multiple interviewees expressed support for resuming formal negotiations on a treaty protocol, including verification. Scientific advancements and emerging capabilities in biotechnology offer potential solutions to historical technical barriers. For example, one independent expert identified genetic tags or signatures as a tool for tracking the origin of biological agents, a capability that did not exist in 2001. Interviewees explicitly discussed remote monitoring systems, microbial forensics, and attribution as potential beneficiaries as well. They broadly expressed support for a BWC mechanism to monitor advancements in science in technology, including to identify technologies that could benefit the treaty and its implementation, and they emphasized that engagement with the scientific community can inform delegations on emerging technical capabilities that could increase benefits or mitigate shortcomings for various assurance mechanisms. Finally, multiple interviewees commented that the COVID-19 pandemic could provide the impetus and political attention needed to take positive steps on a variety of BWC issues. Several emphasized, however, that states parties may have only a short window of opportunity before attention wanes or the next crisis emerges, and that the Ninth Review Conference and early years of the next ISP provided forums to act on these important challenges.

Discussion

These interviews highlighted the absence of common definitions or understanding for core BWC concepts, including verification and compliance, calling attention to the need for explicit debate and negotiations at the international level to generate consensus around the scope and purpose in each application. The diversity of perspectives on these core BWC concepts and the uncertainty regarding how and when they apply to BWC-related activities and obligations pose barriers to debate on concrete steps to improve treaty implementation. While there certainly are technical challenges to overcome in breaking the stalemate on BWC verification and developing a legally binding treaty protocol, perhaps the first step should be agreement on the definitions of key terms, which is much more of a political issue. The BWC can draw lessons from other nonproliferation treaties; however, those applications of verification, compliance, and related concepts do not translate directly to the BWC, given the nature of biological weapons. There is interest among some states parties in resuming negotiations on a legally binding BWC protocol, including a verification regime, but the need for common definitions and understandings extends across a broader swath of BWC issues.

The absence of common understanding on core concepts makes negotiations difficult, as states parties and other stakeholders may be negotiating entirely different issues. Without first agreeing on what is being negotiated, states parties cannot even identify their goals for the negotiations, let alone hold substantive debate on the best ways to achieve them. Without a common understanding on the scope and purpose of BWC verification and compliance, states parties have little opportunity to maneuver toward concrete improvements to the treaty or its implementation. In the context of a legally binding protocol, there remain questions regarding the scope of compulsory activities. With respect to verification, there exist a myriad of uncertainties and disagreements about what would be verified. Critically, the scope and purpose of a verification regime, or compliance assessment, dictate the activities required to implement it and the acceptable degree of uncertainty regarding states parties’ biological activities. The absence of clear distinctions between related concepts—such as verification and compliance or verification and monitoring—further complicates debate regarding appropriate mechanisms or strategies for achieving key objectives under the BWC. States parties would also need to agree on the burden of proof and standards for assessing compliance or verifying other aspects of the treaty. If states parties aim to restart discussions or negotiations on a legally binding protocol, including verification, solidifying the scope and context for these concepts should be a priority.

Without a formal verification or compliance-assessment regime, a broader approach, such as assurance, could help increase transparency, build and maintain trust and confidence, bolster certainty, and mitigate ambiguity and concern across a broad scope of BWC-related obligations and activities. The authors envision assurance as a means to facilitate dialogue on concepts central to the functioning of the BWC. By framing debate outside the narrow context of terms such as “verification” and “compliance,” it could enable the BWC to adapt to evolving threats and capabilities as well as states parties’ changing needs and priorities.

Conflict remains regarding states parties’ focus on developing and adopting a legally binding protocol versus improving treaty implementation and impact.Footnote29 Many states parties continue to prioritize a comprehensive, legally binding protocol and formal verification regime, but there is also support for implementing assurance-related activities incrementally, either as a formal component of the BWC or in an informal or voluntary capacity. Notably, an incremental approach has support among some states parties that desire a comprehensive treaty protocol, which potentially signals opportunity for negotiation on a stepwise path toward a more comprehensive system. By using assurance to expand the scope of dialogue, states parties and stakeholders can identify priority goals under the BWC and appropriate mechanisms to support them. There are some examples of historical efforts to distinguish compliance assessment from verification—including broader approaches, beyond the narrow confines of verification, to increase transparency regarding treaty implementationFootnote30—but for many stakeholders, these concepts remain inextricably linked. Any assurance mechanism will have its own particular capabilities and limitations, and states parties can participate in those activities that serve their individual needs without requiring consensus across all states parties. There are limitations to implementing voluntary mechanisms, but incremental steps toward increased transparency and confidence in states parties' activities could foster increased trust and mitigate the risk that ambiguity will lead to concern. Universal participation is not necessary to increase assurance in the same way it would be for a formal, legally binding verification regime. There is support for a broad range of activities and mechanisms, including some that already exist under the BWC and others that could be implemented in formal or informal ways. Thus, states parties might consider an incremental approach to increasing their degree of assurance regarding other states parties’ biological activities, implementing specific mechanisms to support specific goals in the absence of a comprehensive protocol.

While there is no way to universally determine the benefit of all assurance mechanisms, many proposals could provide value by increasing the degree of certainty that states parties are meeting their BWC obligations. Interviewees did not identify any novel assurance mechanisms, but a broad range of options are on the table. The most substantial barrier lies in agreeing on the details of their implementation. Variations in how each mechanism is implemented will affect the degree to which it contributes to assurance. Some options are better suited to facilitating transparency, such as voluntary peer review or site visits. Others are more appropriate for mitigating a state party's concern about activities by another state party, such as formal consultations under Article V. And some, including on-site inspections, are better suited to assessing specific activities, facilities, or capabilities. Whatever the purpose, however, no single activity is sufficient to provide a comprehensive assessment of states parties’ biological activities. States parties must identify appropriate packages of mechanisms to achieve specific aims, leveraging their relative advantages and selecting combinations of activities to mitigate their respective limitations. Details regarding the mechanisms’ purpose, scope, and implementation will directly affect states parties’ willingness to participate, and disagreements on these details are generally where negotiations fail, even on mechanisms with broad support in principle. Some states parties may find assurance mechanisms unacceptable in the absence of a consensus agreement, but bilateral and multilateral efforts could still have a positive effect in increasing assurance regarding biological activities, facilities, or events.

Fortunately, some assurance mechanisms already exist formally within the BWC, either as components of the treaty itself or derived from politically binding obligations or other consensus agreements by states parties. Options such as CBMs and Article V consultations offer opportunities to increase transparency, mitigate ambiguity, and build trust among states parties, but existing implementation barriers limit their capacity to increase assurance in their current form. There are many calls to increase CBM participation and improve the quality of reports as well as for states parties to make reports publicly available. Article V has been invoked previously, but the stigma around its use and the absence of clear operational procedures hinder its value. There is interest among some states parties in utilizing Article V consultations more routinely to mitigate concern regarding biological activities. Additionally, international cooperation and assistance under Article X can facilitate the sharing of valuable information and best practices and can support states parties’ national implementation, including oversight and regulatory programs and national legislation, as well as capacity building to mitigate the effects of a deliberate biological event. National implementation demonstrates commitment to the BWC and associated norms as well as the capacity to ensure that domestic biological activities comply with treaty obligations. Together, commitment and capacity can increase confidence and mitigate uncertainty. Considering that these options already exist as formal components of the BWC, negotiating changes, procedures, or standards may not face the same barriers to achieving consensus as would implementing wholly new mechanisms. States parties did not take any explicit action on these mechanisms at the Ninth Review Conference; however, they established a working group on strengthening the BWC, which will convene during the 2023–26 ISP. The working group's mandate provides an opportunity for states parties to refine these mechanisms, establish operational frameworks, and expand participation in these activities, with a view toward concrete decisions at the Tenth Review Conference, which is to be held no later than 2027.Footnote31

One of the most pressing challenges facing the BWC is responding to emerging science and technology, including capabilities that pose new threats or offer new solutions.Footnote32 States parties and independent experts understand the importance of ensuring that the BWC remains relevant in the face of radical changes in biotechnology. Efforts are ongoing to promote awareness among BWC delegations regarding emerging capabilities and threats. These efforts include the meetings of experts during the previous ISP, the new working group during the current ISP, and countless educational events on the margins of BWC meetings. There are calls for the BWC to develop its own internal capacity to monitor these advances, such as a scientific advisory mechanism or board. Despite broad agreement on the importance of this capacity, there remain questions regarding how best to implement it, and no decision was made at the Ninth Review Conference. Regardless of the approach, the BWC should expand the inclusion of technical expertise from the scientific community to update diplomats on cutting-edge progress and emerging capabilities that could pose new threats or offer support for BWC implementation.

The absence of sufficient organizational capacity for the BWC poses major barriers to implementing many of these assurance mechanisms. In contrast to analogues in other nonproliferation treaties (for example, the OPCW and IAEA), the three-person BWC ISU is woefully under-resourced. There is broad support for expanding the personnel, funding, and mandate for the ISU. Prospective activities such as science and technology review or analysis of CBM reports would likely not be possible under the ISU's current form, nor would coordinating assurance-related activities, including on-site inspections or more frequent Article V consultations, or supporting states parties’ national implementation efforts. At the Ninth Review Conference, states parties could not reach consensus agreement to add new ISU personnel dedicated to supporting science-and-technology review or international cooperation and assistance or to expand the ISU mandate,Footnote33 but they did add one full-time general staff position to bring the ISU to four total personnel.Footnote34 The Ninth Review Conference was likely the last opportunity to make major changes to the ISU before the Tenth Review Conference.

Many of these issues have been addressed previously in other publications and forums,Footnote35 but those efforts have largely focused on review of historical statements, events, and commentary. The use of a robust dataset and systematic methodology in this study enabled the identification of key themes related to verification based on current perceptions among states parties and other experts. This systematic, data-driven effort documents both the diversity in how states parties understand core concepts under the umbrella of BWC assurance and general support for a myriad of assurance-related mechanisms, including the possibility of implementing mechanisms incrementally in the absence of a comprehensive, legally binding protocol. This study identifies priority topics for future debate, including in the current ISP, that offer the opportunity for concrete progress toward strengthening the BWC and its implementation, based on direct input from states parties and other key stakeholders.

Limitations

While this study utilized a systematic methodology, it was not without limitations. Purposive sampling was used to identify key contributors to the BWC—including broad geographic and political diversity—but it was not possible to invite or interview all states parties. Key BWC-delegation members for priority states parties were identified through official participant lists for past BWC and other nonproliferation meetings, but it was not always possible to locate contact information for key representatives. While all interviews were conducted on a not-for-attribution basis and appropriate measures were implemented to ensure confidentiality and safeguard interview data, some invitees may have been unwilling to speak to a US-based civil-society organization about contentious issues such as verification. Multiple states parties did not respond to invitations, and one declined to participate. Additionally, interviewees’ statements may not necessarily reflect the official position of their organization or country. This study was not intended to assess the suitability of any specific view or the effectiveness of any assurance mechanism, although interviewees’ perspectives on these issues are included, where appropriate. Rather, the study was designed to document the landscape of understanding and perceptions of topics related to BWC verification. While interviewees’ comments may not be generalizable across relevant organizations, including BWC delegations, they do provide insight into the breadth of perspectives on these important issues and help identify topics that have support, as well as associated barriers and challenges.

This analysis relied on extensive interview notes, rather than transcripts. Internal capacity for transcription was not available, and the researchers elected not to transmit interview audio to an external service. Considering the politically sensitive nature of these topics, the researchers took a conservative approach to promote open and transparent conversation. Due to the focus on terminology, the researchers attempted to accurately capture key language in the interview notes, but even with supplementary audio recordings, it is possible that some interview content may have been accidentally omitted, misinterpreted, or not fully contextualized, which could affect the nuanced understanding of these complex concepts. All interviews were conducted in English, which was not the primary language for every interviewee, and differences in translation of key terms could affect the interpretation of their comments. The quantitative analysis placed more emphasis on themes addressed frequently than on remarks made by only one or a few interviewees. In an effort to capture minority perspectives, all coded interview notes were reviewed for priority themes identified a priori, independent of quantitative metrics, although it was not possible to reflect all perspectives in the findings.

Conclusion

The Ninth BWC Review Conference provided states parties with an opportunity to shape future dialogue on verification and other critical issues. The previous ISP, particularly the meetings of experts, illustrated that states parties can have constructive and substantive debate on issues central to the functioning of the treaty, and these discussions can lead to progress on specific issues. At the Ninth Review Conference, states parties were ultimately unable to agree on a number of concrete proposals with broad support, including proposals to establish a science-and-technology review mechanism, provide dedicated support for CBM submissions, and endorse guidelines for scientific codes of conduct. Additionally, states parties could not agree on language for an article-by-article review of the treaty and associated activities and progress since the previous review conference, an element that is usually included in a review conference's final documents.Footnote36 They were, however, able to reach consensus on an updated ISP format and an additional ISU staff member. Crucially, states parties built on the momentum of the previous ISP in establishing the working group on strengthening the BWC. The working group has a broad mandate to “identify, examine and develop specific and effective measures, including possible legally-binding measures” on a range of priority topics under the umbrella of assurance, including verification, compliance, confidence, and transparency. This new ISP format represents a notable departure from the previous meeting-of-experts structure, which consisted of more general debate on challenges facing the treaty, and shifts the focus to identifying concrete measures to strengthen treaty implementation, with the explicit inclusion of compliance, verification, and “possible legally-binding measures."Footnote37 Undoubtedly, the additional ISU staff position will provide critical organizational support for the BWC, which will enable the unit to fulfill its mandate to assist existing and prospective states parties in areas such as CBM submissions and treaty universalization.Footnote38

The new working group should engage in deliberate and specific conversations about key terms and concepts, including “verification” and “compliance,” with an eye toward achieving common understanding on their purpose and scope. Even if consensus agreement cannot be reached, substantive debate on these issues could provide delegations with insight into how other states parties approach these fundamental ideas and help identify potential areas for collaboration or avert potential stalemates. This research study identified support for a wide range of mechanisms to achieve specific assurance aims and for technological advancements that may offer solutions to existing barriers. These mechanisms can provide value, even in the absence of a comprehensive verification regime or universal participation, and some states parties are interested in pursuing those avenues. The working group has the opportunity—and perhaps more importantly, the mandate—to identify states parties’ priority aims related to verification and compliance assessment and to develop mechanisms to meet those goals, potentially including legally binding activities for consideration at the Tenth Review Conference. Additionally, the mandate extends beyond just compliance and verification to include confidence building and transparency, which enables the working group to evaluate a wide range of tools. These tools could form part of a comprehensive package or serve as incremental or modular steps toward increased assurance. The broader concept of assurance provides a new framework for debate on efforts to increase certainty regarding states parties’ adherence to their treaty obligations—whether through verification, compliance assessment, confidence building, or transparency—including those that could be implemented in the absence of a comprehensive, legally binding protocol or verification regime.

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Acknowledgments

The authors would like to thank all the participants in their study for taking the time to share their expertise, particularly in the midst of a pandemic. They would also like to thank Open Philanthropy for its financial support of this study, as well as its continued interest in the BWC and biological-weapons nonproliferation and its commitment to promoting the broadest use of science for peaceful purposes.

Additional information

Notes on contributors

Matthew P. Shearer

Matthew P. Shearer is an associate scholar at the Johns Hopkins Center for Health Security (JHCHS) and a senior research associate in the Department of Environmental Health and Engineering at the Johns Hopkins Bloomberg School of Public Health. His research spans infectious-disease epidemiology; outbreak, epidemic, and pandemic preparedness and response operations and policy; global health security; and biological-weapons nonproliferation policy. He earned a BS in aerospace engineering from the US Naval Academy and an MPH in epidemiology from the University of Michigan School of Public Health. Mr. Shearer represents JHCHS at Biological and Toxin Weapons Convention meetings, and he has supported the BWC Implementation Support Unit in hosting regional workshops on developing preparedness and response capacity for deliberate biological events. His recent publications focus on outbreak and pandemic response, including the 2017–19 US measles epidemic, mass vaccination operations, and serological testing strategies during the COVID-19 pandemic.

Christina Potter

Christina Potter is a senior analyst at the Johns Hopkins Center for Health Security and a research associate in the Department of Environmental Health and Engineering at the Johns Hopkins Bloomberg School of Public Health (BSPH). Her primary research interests include outbreak preparedness and response in domestic and international contexts and the intersection between health-systems strengthening and health security. Ms. Potter develops qualitative and mixed-methods methodological approaches to research complex health-security challenges. She received her MSPH in global disease epidemiology and control from BSPH and her BS in cell and molecular biology from Northeastern University.

Rachel A. Vahey

Rachel A. Vahey is an analyst at the Johns Hopkins Center for Health Security (JHCHS) and a research associate at the Johns Hopkins Bloomberg School of Public Health (BSPH). She earned her MHS in environmental health from BSPH, where her thesis evaluated the environmental and public-health effects of the livestock industry in the United States. This effort built upon the research she performed at the University of Georgia during her studies to obtain an agrosecurity certificate. Her interests and work at JHCHS include agrosecurity, One Health, civil–military collaboration on health-related threats, and chemical, biological, radiological, and nuclear threats. Her recent publications focus on pandemic response, including the equity of public-health measures for the criminal-justice system; ventilation and return-to-school measures during the COVID-19 pandemic; and the potential application of canine detection teams for outbreak response.

Nancy D. Connell

Dr. Nancy D. Connell is professor emerita at Rutgers New Jersey Medical School, where she taught from 1992 to 2018, and is a senior scientist on the Board of Life Sciences at the US National Academies of Sciences, Engineering, and Medicine (NASEM). From 2018 to 2021, she was a senior scholar at the Johns Hopkins Center for Health Security. Trained in microbial genetics at Harvard University, her work focuses on life-sciences technologies and their application to developments in biosecurity, biosafety, and biodefense. Her recent research analyzes novel biotechnologies that impact the development and use of biological weapons and the impact of artificial-intelligence-based methodologies on the life sciences. She has long been involved in the development of regulatory policies associated with biocontainment and dual-use research of concern. Dr. Connell is a past member of NASEM’s Board on Life Sciences and Committee on International Security and Arms Control. Among other national and international committees, she has served on the US National Science Advisory Board for Biosecurity.

Gigi Kwik Gronvall

Dr. Gigi Kwik Gronvall is a senior scholar at the Johns Hopkins Center for Health Security and an associate professor in the Department of Environmental Health and Engineering at the Johns Hopkins Bloomberg School of Public Health. An immunologist by training, she is the author of the books Synthetic Biology: Safety, Security, and Promise (2016) and Preparing for Bioterrorism: The Alfred P. Sloan Foundation’s Leadership in Biosecurity (2013). She is a member of the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC), which provides recommendations to the director of the US National Institutes of Health and is a public forum for the discussion of scientific, safety, and ethical issues associated with emerging biotechnologies. From April 2009 to February 2010, Dr. Gronvall served as the science adviser for the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism. She currently is a member of the US Department of State's International Security Advisory Board.

Notes

1 UN Office of Disarmament Affairs, "History of the Biological Weapons Convention," n.d., <https://www.un.org/disarmament/biological-weapons/about/history/>.

2 Chemical Weapons Convention, April 29, 1997, Annex on Implementation and Verification; Treaty on the Non-Proliferation of Nuclear Weapons, July 1, 1968, Article III, para. 1; International Atomic Energy Agency (IAEA), “The IAEA and the Non-Proliferation Treaty,” n.d., <https://www.iaea.org/topics/non-proliferation-treaty>.

3 Sonia Drobysz, "Verification and implementation of the Biological and Toxin Weapons Convention," Nonproliferation Review, Vol. 27, Nos. 4–6 (2020), pp. 487–97.

4 Ad Hoc Group of Governmental Experts to Identify and Examine Potential Verification Measures from a Scientific and Technical Standpoint, “Summary of the work of the Ad Hoc Group for the period 30 March to 10 April 1992,” BWC/CONF.III/VEREX/2, para. 1, April 13, 1992, <https://unoda-documents-library.s3.amazonaws.com/Biological_Weapons_Convention_-_Ad_Hoc_Group_on_VEREX_First_session_(1992)/BWC_CONF.III_VEREX_2.pdf>.

5 Ad Hoc Group of the States Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, Procedural Report, first session, January 4–6, 1995, BWC/Ad Hoc Group/3, para. 1, <https://unoda-documents-library.s3.amazonaws.com/Biological_Weapons_Convention_-_Ad_Hoc_Group_First_session_(1995)/BWC_AHG_03.pdf>.

6 US Department of State, “Statement by the United States to the Ad Hoc Group of Biological Weapons Convention States Parties,” July 25, 2001, <https://2001-2009.state.gov/t/ac/rls/rm/2001/5497.htm>.

7 Permanent Mission of the Republic of Azerbaijan to the UN Office and Other International Organizations in Geneva, "2020 Meeting of the States Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction: General Statement on behalf of the Non-Aligned Movement and other States Parties to the Biological and Toxin Weapon Convention delivered by the Permanent Mission of the Republic of Azerbaijan to the United Nations Office in Geneva," November 22–25, 2021, <https://documents.unoda.org/wp-content/uploads/2021/11/Azerbaijan-on-behalf-of-NAM-Gen-Debate.pdf>.

8 UN Office of Disarmament Affairs, "Biological Weapons Convention – Meeting of Experts (2018)," n.d., <https://meetings.unoda.org/bwc-mx/biological-weapons-convention-meeting-experts-2018>.

9 Trevor Findlay, "Verification and the BWC: Last Gasp or Signs of Life?," Arms Control Today, September 2006, pp. 17–21, <https://www.armscontrol.org/act/2006-09/features/verification-bwc-last-gasp-signs-life>; Carmen Wunderlich, Harald Müller, and Una Jakob, "WMD compliance and enforcement in a changing global context," WMD Compliance & Enforcement Series, No. 11, UN Institute for Disarmament Research, 2021, <https://unidir.org/WMDCEChangingGlobalContext>.

10 Since the BWC entered into force in 1975, nine review conferences have been held—in 1980, 1986, 1991, 1996, 2001/2002, 2006, 2011, 2016, and 2022.

11 Richard Lennane, "Verification for the BTWC: if not the protocol, then what?" Disarmament Forum, 2011, No. 1, pp. 39–50, <https://unidir.org/sites/default/files/publication/pdfs//beyond-the-btwc-rev-con-en-313.pdf>.

12 Nicholas S. Sims and Jez Littlewood, "Ambitious Incrementalism," Nonproliferation Review, Vol. 18, No. 3 (2011), pp. 499–511.

13 “Statement by [US] Under Secretary of State Bonnie Jenkins to the 2021 Biological Weapons Convention Meeting of State Parties,” November 22, 2021, <https://documents.unoda.org/wp-content/uploads/2021/11/US-FINAL-updated.pdf>; "Statement by the Representative of the Russian Delegation at the Meeting of States Parties to the Biological and Toxin Weapons Convention (BWC) on Agenda Item 5 'General Debate,'” November 22, 2021, <https://documents.unoda.org/wp-content/uploads/2021/11/Russian-Federation-final-EN.pdf>. The scheduled 2020 meeting was postponed to 2021 because of the COVID-19 pandemic.

14 The term "key informants” encompasses practitioners and researchers who have specialized expertise on a given topic by virtue of their experience or study.

15 Filippa Lentzos, "Compliance and Enforcement in the Biological Weapons Regime," WMD Compliance & Enforcement Series, No. 4, UN Institute for Disarmament Research, 2019, <https://unidir.org/publication/compliance-and-enforcement-biological-weapons-regime>.

16 Article IV of the BWC obligates states parties to take appropriate measures at the national level to "prohibit and prevent" the proliferation of biological weapons within their territory, which is commonly referred to as "national implementation" of the BWC. See Biological and Toxin Weapons Convention, March 26, 1975, Article IV.

17 Analogous mechanisms include declarations, routine inspections, and challenge or special inspections of relevant facilities, such as those under the Chemical Weapons Convention or the Treaty on the Non-Proliferation of Nuclear Weapons. See Chemical Weapons Convention, April 29, 1997, Annex on Implementation and Verification; and International Atomic Energy Agency, IAEA Safeguards Glossary: 2022 Edition, 2022, ch. 10, <https://www-pub.iaea.org/MTCD/Publications/PDF/PUB2003_web.pdf>.

18 Special Conference of the State Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (September 19–30, 1994), Final Report, BWC/SPCONF/1, Part II, para. 36, <https://docs-library.unoda.org/Biological_Weapons_Convention_-_Special_Conference__(1994)/BWC_SPCONF_01.pdf>.

19 Anti-Personnel Mine Ban Convention, March 1, 1999.

20 Convention on Cluster Munitions, August 1, 2010.

21 UN Office for Disarmament Affairs, "Nuclear-Weapon-Free Zones," n.d., <https://www.un.org/disarmament/wmd/nuclear/nwfz/>.

22 UN Office at Geneva, “Overall rate of CBM Report submissions,” n.d., <https://bwc-ecbm.unog.ch/>.

23 Second Review Conference of the Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction, Final Document, BWC/CONF.II/13, Part III, para. 20, 1986, <https://unoda-documents-library.s3.amazonaws.com/Biological_Weapons_Convention_-_Second_Review_Conference_(1986)/BWC_CONF.II_13.pdf>.

24 Organisation for the Prohibition of Chemical Weapons, "Scientific Advisory Board: Keeping pace with scientific and technological change," 2022, <https://www.opcw.org/about/subsidiary-bodies/scientific-advisory-board>.

25 "The States Parties to this Convention undertake to consult one another and to co-operate in solving any problems which may arise in relation to the objective of, or in the application of the provisions of, the Convention … " See Biological and Toxin Weapons Convention, Article V.

26 Biological and Toxin Weapons Convention, Article VI.

27 Tianjin University Center for Biosafety Research and Strategy, Johns Hopkins Center for Health Security, and Interacademy Partnership, "The Tianjin Biosecurity Guidelines for Codes of Conduct for Scientists," July 7, 2021, <https://www.centerforhealthsecurity.org/our-work/Center-projects/IAPendorsementTianjinCodes/20210707-IAP-TianjinGuidelines.pdf>.

28 Lentzos, "Compliance and Enforcement."

29 Jez Littlewood, The Biological Weapons Convention: A Failed Revolution (Hampshire, UK: Ashgate Publishing, 2005), ch. 9.

30 Meeting of the States Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, "Revised: National implementation of the BTWC: compliance assessment: a concept paper, submitted by Canada," BWC/MSP/2010/WP.3/Rev.1, December 7, 2010, <https://documents-dds-ny.un.org/doc/UNDOC/GEN/G10/639/23/PDF/G1063923.pdf >.

31 Ninth Review Conference of the States Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, Final Document of the Ninth Review Conference, BWC/CONF.IX/9, December 22, 2022, Part II, paras. 8–16 <https://undocs.org/en/BWC/CONF.IX/9>.

32 James Revill, Alisha Anand, and Giacomo Persi Paoli, "Exploring science and technology review mechanisms under the Biological Weapons Convention," UN Institute for Disarmament Research, 2021, <https://unidir.org/exploring-science-and-tech>.

33 Ninth Review Conference of the States Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, Draft Final Document of the Ninth Review Conference, BWC/CONF.IX/CRP.2/Rev.1, Part III, <https://unodaweb-meetings.unoda.org/public/2022-12/2022-1213%20draft%20final%20document%20CRP_2_Rev_1.pdf>.

34 Ninth Review Conference, Biological and Toxin Weapons Convention, Final Document, Part II, para. 25.

35 Lentzos, "Compliance and Enforcement"; Sims and Littlewood, "Ambitious Incrementalism"; Marie Isabelle Chevrier, "Compliance mechanisms and their implementation: the contrast between the Biological and Chemical Weapons Conventions," Nonproliferation Review, Vol. 27, Nos. 4–6 (2020), pp. 475–86; James Revill, "Compliance Revisited: An Incremental Approach to Compliance in the Biological and Toxin Weapons Convention," CNS Occasional Paper No. 31, Middlebury Institute of International Studies at Monterey, August 2017, <https://www.nonproliferation.org/wp-content/uploads/2017/08/op31-compliance-revisited.pdf>; Findlay, "Verification and the BWC”; Iris Hunger and Anna Zmorzynska, "Verifying and Demonstrating Compliance with the BTWC," Non-Proliferation Papers No. 5, EU Non-Proliferation Consortium, December 2011, <https://www.files.ethz.ch/isn/136364/EUNPC_no%205.pdf>.

36 Ninth Review Conference, Biological and Toxin Weapons Convention, Draft Final Document, Rev. 1, BWC/CONF.IX/CRP.2/Rev.1, Part III.

37 Ninth Review Conference, Biological and Toxin Weapons Convention, Final Document, Part II, paras. 8–16.

38 Ninth Review Conference, Biological and Toxin Weapons Convention, Final Document, Part II, paras. 24–27; Sixth Review Conference of the States Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, Final Document, BWC/CONF.VI/6, Part III, paras. 5–6, <https://documents-dds-ny.un.org/doc/UNDOC/GEN/G07/600/30/PDF/G0760030.pdf>.