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Increasing assurance under the BTWC through biorisk management standards

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The final report of the 7th Review Conference of the Biological and Toxin Weapons Convention (BTWC) held in December 2011 contained a one-line subparagraph whose ambition came to fruition in December 2019. Under Article IV (on national implementation measures), paragraph 13 opened as follows:

The Conference notes the value of national implementation measures, as appropriate, in accordance with the constitutional process of each State Party, to:

     (a) implement voluntary management standards on biosafety and biosecurity;

That single line of new language in the final report was the outcome of a preparatory process that had begun in September 2009 and led to a Belgian Review Conference working paper endorsed by the European Union (EU). Prompted by the final report’s language, the International Organisation for Standards (ISO) initiated the complex procedure for developing a new standard. Just over seven years after the 7th Review Conference, it published the new standard, ISO 35001:2019 Biorisk management for laboratories and other related organisations.

ISO 35001:2019 – Biorisk management standard

Today, amid the global pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), questions about the virus’s origins abound. Might it have escaped from a high-containment laboratory? Did the epidemic result from a deliberate release? While we can source most of these claims to conspiracy theorists and wilful disinformation propagators, the clampdown of Chinese bureaucracy on early outbreak reports, the government’s failure to immediately report the emerging epidemic to the World Health Organisation (WHO), and its subsequent extreme vetting of any scientific publication discussing COVID-19’s origins created the space for the wildest stories to flourish.

Over the next months and years researchers from many disciplines will analyse the response by the WHO and the adequacy of the outbreak reporting requirements under the International Health Regulations. Even though nothing suggests that COVID-19 resulted from a deliberate release of a pathogen or that the virus was artificially created or genetically altered in a laboratory, different aspects of the BTWC regime relate to the reporting of outbreaks, biosecurity and -safety in laboratories and other installations, and international cooperation.

Interesting in this respect is whether the new ISO standard offers opportunities to reinforce the BTWC. In preparation for the 2020 BTWC Meetings of Experts (MX), to be held exceptionally in December instead of the late summer due to COVID-19 meeting restrictions at the United Nations, Belgium with Austria. Chile, France, Germany, Iraq, Ireland, Netherlands, Spain and Thailand submitted a working paper entitled ‘Biorisk management standards and their role in BTWC implementation’ (BWC/MSP/2020/MX.2/WP.2, 27 October2020).

Early genesis of a small success

September 2009. I was a disarmament researcher at the Paris-based European Union Institute for Security Studies (EU-ISS). The 7th BTWC Review Conference was just over two years away. I met with an acquaintance from my days at the Stockholm International Peace Research Institute (SIPRI) and a senior official at the Foreign Ministry in Brussels. I had a straightforward question for them. Belgium would hold the 6-monthly rotating Presidency of the European Council during the second half of 2010. A year before the Review Conference, this was the ideal time to update the EU Common Position for the quinquennial meeting.

Holding the Presidency offers plenty of opportunities for initiative. In 2009 EU members had no specific plans to update their common position. The 6th Review Conference they considered a success (which was relative considering the disaster five years earlier). Three months after the meeting in Brussels, the Belgian Foreign Ministry decided to seek an updated EU position. Preparations already began under the Swedish Presidency during the first half of 2010.

The idea I had put forward in Brussels was maximalist: how to equip the BTWC with verification tools? I was not seeking to reopen the Ad Hoc Group (AHG) negotiations the United States had aborted in 2001 because by the turn of the century I had already come to the conclusion that the tools under consideration in Geneva addressed past problems and not the most recent developments in biology and biotechnology. Many academics observing the AHG deliberations recognised the shortcomings of the draft text but pushed for completing the draft protocol to the BTWC, fearing that the proceedings were losing momentum. However, their argument that the protocol could be amended afterwards I did not share. In my mind, a return to the design board was the only option.

On the way to a national and common EU position

On 18 May 2010, during the Swedish Presidency, the EU Council’s Working Party on Global Disarmament and Arms Control (CODUN) invited me to present my thoughts on how to strengthen the BTWC. CODUN coordinated the EU’s Common Foreign and Security Policy regarding global disarmament and UN-related issues, which included the BTWC. (CODUN has since then been absorbed into the Working Party on Non-proliferation – CONOP.) In the EU-ISS note prepared for the briefing I identified five areas of possible progress on verification-related questions: (1) industry verification; (2) biodefence programmes; (3) technology transfers; (4) allegations of BW use and unusual outbreaks of disease; and (5) countering BW threats posed by terrorist and criminal entities. I added the following caveat:

Under the present circumstances it does not appear feasible to consider the five areas in a single, holistic model for a future BTWC. New, non-state actors have risen to prominence in the disarmament debate (the industry, scientific and professional communities, but also terrorist and criminal entities). There are different challenges posed by rapid advances in science, technology and processes that may contribute to BW acquisition, the major changes in the international security environment over the past three decades (and since the 9/11 attacks and the invasion of Iraq in particular) and the resulting changes in security expectations from weapon control treaties and their verification tools.

The main aim for the EU, I suggested, was to

obtain a decision at the 7th Review Conference establishing one or more working groups to explore and identify novel approaches to verifying the BTWC. These working groups are to meet several times during the next intersessional period and report to the 8th Review Conference in 2016, at which point States Parties may decide to act on the findings.

     Critical elements in the deliberations will be: (1) the building and application of the principle of multi-stakeholdership, with direct participation of the industrial and scientific communities; (2) the identification of processes and technologies to support the verification goals, and, where required, to identify such processes and technologies that need to be created and developed based on the latest scientific and technological advances, e.g., in detection or biological forensics; and (3) for the EU, to actively support the process by taking the lead in testing the proposed verification methodologies in realistic settings with a view of both ascertaining their feasibleness and finetuning the proposals.

The latter element was critical for deliberations to move from the conceptual to the practical. In a footnote, I clarified:

This aspect is particularly important with respect to the design and implementation of novel verification principles, techniques and technologies. For example, before the signing of the 1987 Treaty on the Intermediate-Range Nuclear Forces (INF) the United States and the Soviet Union had conducted over 400 trial inspections. The goals of those trials included the testing of the concept of onsite inspection, the finetuning of verification requirements and the investigation of ways in which sensitive information could be protected without undermining the stated verification goals.

The remainder of the note addressed the five issue areas. The document ended with a separate section on stakeholders and their involvement in verification, which included arguments to have industry and the scientific communities engaged in the preparatory processes.

Sharpening the focus

After that intervention, I continued to interact with the Belgian Foreign Ministry regarding the RevCon preparations. Early in June, less than one month before Belgium was to take over the rotating Presidency from Sweden, the Foreign Ministry convened a seminar with representatives from different ministries and agencies, national stakeholders and a few international experts. Participants discussed a full spectrum of issues affecting the BTWC at the time: verification, industry involvement in the discussions, biosecurity and safety, science and technology, etc. The seminar’s purpose was to combine desired options with feasible outcomes, ‘feasibility’ meaning first gaining consensus for the proposal among the 28 EU members and then adoption of language by the BTWC states parties at the 7th Review Conference.

BSL4 lab at Boston University’s National Emerging Infectious Diseases Laboratories (Source: Flickr)

During the second intersessional process between the 6th and 7th Review Conferences (2007–10), topics such as biosecurity and -safety, science oversight, codes of conduct, pathogen regulation, etc. featured prominently on the agenda. One year later, in June 2011, the Belgian Foreign Ministry organised its second seminar in preparation of the 7th Review Conference. Its topic caused little surprise: The Biological Weapons Convention, Biosecurity and the Industry. One of the seminar’s central themes was to investigate how the life sciences industry – one core stakeholder remaining in the background of the discussions on the future of the BTWC – could become more involved. Speakers zoomed in on industrial standards for biosafety and biosecurity being developed for laboratories in research and industry facilities as a possible point of entry. In follow up to the seminar, the idea arose to explore this lesser-known opportunity in more detail and highlight its possibilities and limitations from three perspectives: biorisk management, industry practice and government responsibility in formal disarmament. Ambassador Paul van den IJssel, President-Designate of the 7th BTWC Review Conference, closed the event.

One advantage of homing in on biorisk management (the term ‘biorisk’ reflects the common all hazards approach) was precedent. The European Committee for Standardisation (CEN, after its French name: Comité européen de normalisation) had adopted a CEN Workshop Agreement (CWA) on Laboratory biorisk management standard in February 2008, known as CWA 15793:2008. (The standard was updated in September 2011 as CWA 15793:2011.) As Gary Burns and Toon De Kesel explained at the seminar:

The most obvious benefits for organisations implementing CWA 15793 include improved biosafety and biosecurity performance ensuring protection for employees and the wider community, as well as preventing loss, theft, and misuse of biological materials with dual-use potential. Compliance with the standard furthermore avoids direct financial costs associated with business interruption, ensures conformity with legal requirements and helps to avert penalties or litigation. An additional, yet significant benefit concerns the preservation of an organisation’s reputation.

An organisation that obtained formal certification as meeting the requirements of the CWA may be able to negotiate lower insurance premiums and reduce the number of interventions by regulators. Conformity also helps to promote the exchange of materials and expansion of research collaboration, as the CWA assures that receiving/collaborating organisations can handle hazardous materials safely and securely. It also improves prospects when bidding for contracts or research funding. [...]

[See their chapter in: Jean Pascal Zanders (ed.), Setting A Standard for Stakeholdership Industry Contribution to a Strengthened Biological and Toxin Weapons Convention, Egmont Paper 52 (Egmont – The Royal Institute for International Relations: Brussels, December 2011).]

Relevant institutions thus have an interest in obtaining certification under an international standard. Burns and De Kesel further explored a standard such as CWA 15793 could contribute to providing increased assurance under the BTWC, provided modifications were implemented. They argued in favour of transforming the CWA into an ISO standard, which could also include health and safety and be translated into more languages thereby benefiting global application.

The concrete proposal

In paragraph 9 of its working paper entitled ‘Biorisk management standards and their role in BTWC implementation’ (BWC/CONF.VII/WP.7, 14 October 2011) Belgium called on the Review Conference to:

     (a) Recognise that biorisk management standards, created by stakeholders in the life sciences community, can play a complementary and supportive role in the implementation of the obligations of the BTWC;

     (b) Call on the life sciences community and international standards organisations to develop global and certifiable biorisk management standards;

     (c) Encourage states parties to provide assistance, where appropriate, for the implementation of biorisk management standards in life science institutions in accordance with Article X;

     (d) Take biorisk management standards and their role for BTWC implementation up as an intersessional topic and enter into dialogue with representatives from biosafety associations, the life sciences industry and international standards organisations on the development of new standards, and review of existing standards, in order to enhance their leverage towards the implementation of the BTWC.

The next paragraph also clarified that industrial standards are not a governmental affair and that therefore states cannot and will not control their development and implementation. In addition, adoption of such standards will not ‘dismiss states from their primordial responsibility for security and the obligation to implement the BTWC by making laws and enforcing them’.

A minor incident occurred when a member of the German delegation was the first to take to the floor in the question and answer session after the formal plenary presentation of the working paper to express his country’s opposition to the proposal. Belgium quickly shut down the challenge by pointing out that the proposal was part of the EU Common Position for the Review Conference adopted by Germany and the 27 other EU members. A few BTWC parties sought some additional clarification about the motives and purpose of the biosafety and -security management standards.

Nobody formally opposed the idea.

Towards the 9th Review Conference (2021)

Following the publication of ISO 35001:2019 on Biorisk management for laboratories and other related organisations, Belgium returns to promoting the standard in the BTWC context. The document notes in paragraph 7:

This development within the life sciences industry strengthens the international capacity to reach the goals of the BTWC in several ways:

     (a) it provides a tool for awareness raising in the scientific community regarding the risks related to biological dual-use items;

     (b) it reduces the risk of unauthorised access to biological agents and materials;

     (c) it provides an increased level of assurance that life science institutions are complying with the prohibitions and obligations of the BTWC;

     (d) it guarantees responsible biorisk management in certified facilities, even in cases where national legislation and regulation fall short of requirements;

     (e) it can facilitate international transactions relevant for Article X assistance;

     (f) it will enhance responsible research of hazardous biological materials, including engineered and synthetically derived materials.

The working paper also refers cautiously to the current global pandemic when it says:

SARS, pandemic viruses and threats of the malicious use of pathogens illustrate the risks that biological agents and materials pose and the need to reinforce safety and security precautions. The productive results of the auto-regulatory initiatives of the life sciences community offer the opportunity to increase safety and security and thus can ameliorate the implementation of the BTWC.

To a degree the working paper could complement the idea launched by Kazakh President Kassym-Jomart Tokayev in his address to the UN General Assembly on 23 September to have an International Agency for Biological Safety linked to the BTWC. As I pointed out in an earlier blog posting, this idea still requires further development. However, the shared interest of Belgium and Kazakhstan in biorisk management in the context of the disarmament treaty is clear.

In conclusion

Thinking back on the little role I played in these developments – essentially contacting the Belgian Foreign Ministry about whether it was planning to update the EU Common Position in preparation of the 7th Review Conference – gives me pleasure. The meeting in September 2009 started the process that eventually led to an ISO standard, which, if embraced by states parties, could evolve into significant building block in the provision of assurance in the BTWC context.

I never expected an ISO standard as an outcome. This may be surprising in hindsight. Having switched SIPRI for the Geneva-based BioWeapons Prevention Project (BWPP) in August 2003, I returned to Stockholm in December for a joint BWPP-SIPRI seminar sponsored by the Swedish Foreign Ministry. Participants included representatives from the Swedish Defence and Trade Ministries, customs, biotechnology industry and the life sciences. A couple of international academic experts attended too. There I presented the first outline of a possible novel transparency-enhancing system. The Weapons of Mass Destruction Commission (more commonly known as the Blix Commission) published the ideas as ‘A Verification and Transparency Concept for Technology Transfers under the BTWC’ in February 2005. An interesting detail: the text already cited the ISO as a source of inspiration and suggested using BTWC Article X as a means to assist states parties with meeting the standards to make the transparency-enhancing system function.

After the adoption of the final report of the 7th Review Conference, my colleague at the Belgian Foreign Ministry asked me whether I was not disappointed that only a reference to biorisk management standards ended up in the document. I had approached him two years earlier with a much broader verification idea. I assured him this was not the case. In BTWC politics, diplomacy is after all the art of the feasible. The global biorisk management standard had a chance in 2011 and has become a reality today.

Is verification off my table? Hell, no! But that will be the subject of a future story.

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