Increasing assurance under the BTWC through biorisk management standards

[Cross-posted from The Trench]

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.

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

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Synthetic biology & biosecurity: How scared should we be?

The link between synthetic biology and heightened biosecurity threats is often exaggerated. In a report published today (22nd May), King’s College London researchers say that in order to produce more refined assessments of the biosecurity threat, we need to understand more clearly what would be achieved by synthetic biology’s goal to ‘make biology easier to engineer’.

Synthetic Biology and Biosecurity: How scared should we be? summarises and analyses the discussions from a workshop organised by Dr Catherine Jefferson, Dr Filippa Lentzos and Dr Claire Marris, at King’s in February 2014.

Synthetic biology’s aim to make biology easier to engineer has raised concerns that it could increase the risk of misuse for biowarfare or bioterrorism. The workshop brought together synthetic biologists, social scientists, policy experts and science journalists to explore whether concerns about these risks are realistic or exaggerated in the light of current scientific realities.

It is often assumed that synthetic biology will ‘de-skill’ biology and that this means that any layperson, working outside professional scientific institutions, is or soon will be able to design and engineer living organisms at will. However, workshop participants argued that this representation is too simplistic. De-skilling does not necessarily mean that skills become irrelevant. As we see in other industries such as aeronautics, de-skilling does not necessarily mean that specialised expertise becomes irrelevant.

The report will be presented at the meeting of experts to the Biological Weapons Convention at the United Nations in Geneva this summer.

Join the discussion and tell us what you think on twitter: #synbiosec

The “Synthetic Biology and Biosecurity” workshop and report formed part of SSHM’s on-going work on the social dimensions of synthetic biology, conducted within the EPSRC funded Centre for Synthetic Biology and Innovation and the Flowers Consortium, and an ESRC funded project on the politics of bioterrorism.

[Original post by Filippa Lentzos; cross-posted from The Trench]