TWN Info Service on Biosafety
5 Jan 2023
Third World Network
www.twn.my
Biodiversity meeting agrees on limited action on technology and synthetic biology
London, 27 December (Lim Li Ching) – Parties to the Convention on Biological Diversity (CBD) have successfully established a process for horizon scanning, monitoring and assessment of the most recent technological developments in synthetic biology.
The outcome was however fraught, with fragile gains. Only one intersessional cycle was agreed to, with no guarantee of the continuation of a process that is supposed to be “broad and regular”, something Parties had already agreed to at their last meeting in 2018.
In discussions on the post-2020 Kunming-Montreal Global Biodiversity Framework (GBF), the biosafety target (Target 17) met with such divergence of views that Parties could only agree to restate existing provisions of the Convention related to the need to regulate, manage or control the risks of living modified organisms (LMOs) resulting from biotechnology, and to the handling of biotechnology and distribution of its benefits.
There were clear divisions between Parties that grow and export genetically modified crops, and other Parties that tend to take more precautionary approaches to LMOs and new genetic technologies, including synthetic biology.
The fifteenth Meeting of the Conference of Parties (COP15) to the CBD met in Montreal from 7 to 19 December, in conjunction with the meetings of its Protocols – the Cartagena Protocol on Biosafety (COPMOP10), and the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (COPMOP 4).
Brazil, at the Working Group plenary concerned, signaled its intentions clearly, calling for a postponement of the discussion on synthetic biology for another two years, to COP16. It claimed that there was “no urgency to discuss this matter” and that the negotiations on the GBF should get full attention.
A Contact Group was set up, co-chaired by Ntakadzeni Tshidada (South Africa) and Werner Schenkel (Germany), with the mandate to address the text remaining in brackets in the draft decision. These brackets reflected the numerous disagreements which could not be resolved at both the online and in-person meetings of the Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA24), held in May/June 2021 and March 2022, respectively.
At the Contact Group meeting, the same proposal to defer the discussion to COP16 was raised again. The Party concerned pointed to the inconclusiveness of the last Ad HocTechnical Expert Group (AHTEG) on Synthetic Biology, as to whether synthetic biology was a “new and emerging issue”, which it said put a question mark on the topic.
[The consolidated modus operandi of SBSTTA lists among its functions that SBSTTA should inter alia identify new and emerging issues relating to the conservation and sustainable use of biodiversity. These issues would then warrant urgent attention by SBSTTA and be placed on its agenda.]
This attempt to stymie the further discussion on synthetic biology under the CBD was supported by a few Parties – from both developed and developing countries. Other Parties objected to this move, given that synthetic biology is an urgent concern with fast developments, and that the issue has already been discussed by SBSTTA and the COP for a decade now, while expressing worries over the implications of deferment on Target 17 of the GBF.
The Co-Chairs of the Contact Group advised that the COP had already adopted the agenda, and that the Group had already been given a mandate. They proposed discussing the substance of the draft decision before coming back to the question of whether synthetic biology is a new and emerging issue.
Disagreements over the regularity of the horizon scanning, monitoring and assessment process were eventually resolved with a compromise of having the process run over one intersessional period, with a built-in review by SBSTTA. The subsidiary body is tasked to consider the interim and final reports on effectiveness of the process and to make a recommendation to COP16 on the need to extend that process.
Multidisciplinary AHTEG
Another key point of contention was around the term “multidisciplinary AHTEG”. The AHTEG on Synthetic Biology had actually recommended that a “Multidisciplinary Technical Expert Group” take on the task of horizon scanning, monitoring and assessment. Previous discussions at SBSTTA24 compromised on this issue, clarifying that an AHTEG would be set up, according to the usual modus operandi, but qualifying the AHTEG by the word “multidisciplinary”.
This was viewed by many Parties as necessary, in order to incorporate the expertise needed to cover the increasing diversity of synthetic biology applications that are rapidly expanding in different fields, and to fully take into account their wide ranging impacts, including cultural and socioeconomic impacts.
However, two large LMO-exporting countries led the charge against this concept.
These arguments were mirrored in the discussion on whether to specify the need to also take into account social, economic and cultural impacts as well as related ethical issues. Decision XIII/17 of COP13 in 2016 had already invited Parties to take into account, in accordance with their applicable domestic legislation or national circumstances, as appropriate, socio-economic, cultural and ethical considerations.
A small group of Parties was tasked to discuss and prepare a compromise solution. The compromise eventually agreed on was to keep the term “multidisciplinary” in reference to the AHTEG, as well as to refer to the report of the previous AHTEG on Synthetic Biology, which consistently highlighted the need to also consider cultural, socioeconomic and ethical dimensions. In exchange, references to these considerations were excluded from this particular decision.
Nonetheless, the AHTEG should include “expertise from a broad range of scientific disciplines, as well as interdisciplinary and intercultural expertise, indigenous peoples and local communities”, while enabling a participatory process. It is also subject to the procedure for avoiding or managing conflicts of interest in expert groups set out in Decision XIV/33 (in 2018).
Returning to the “new and emerging issues” controversy, the Contact Group eventually accepted a compromise to (i) decide not to require further analysis on whether synthetic biology is a new and emerging issue; and (ii) note that this should not be precedent setting, whether for regarding synthetic biology as a permanent item under the Convention, or on the permanent adoption of procedures established in the decision, such as horizon scanning, or on future processes to consider any proposed new and emerging issues.
Regrettably, while this issue of precedence setting was viewed by many to be confined to the agenda item on synthetic biology, the main proponent of this idea used it to delete references to horizon scanning in the COP15 agenda item on “Capacity-building and development and technical and scientific cooperation”.
This intransigent position was also reflected in the discussions on Target 17 of the GBF on biosafety.
Biosafety target – a missed opportunity
During the 5th meeting of the Open-ended Working Group on the Post-2020 GBF from 3 to 5 December that preceded COP15, discussions on the biosafety target were at stalemate, with no movement in Parties’ positions.
Following an initial round of discussions at the Contact Group on the post-2020 GBF, an informal group was set up to continue negotiations at COP15, co-facilitated by Ntakadzeni Tshidada (South Africa) and Tim Strabala (New Zealand).
The gulf was so wide between Parties that wanted a precautionary approach to apply and to explicitly focus the target also on synthetic biology and new genetic techniques, and those that did not want to do so, but instead wanted a nod to science-based measures and recognizing the benefits from biotechnology, that bridging it became impossible.
The only thing that could be agreed on was to restate provisions of the CBD. All other proposed elements of the target, such as horizon scanning, monitoring and assessment, and socio-economic considerations, were dropped.
Even the restatement of the CBD’s provisions of Article 8(g) on the need to regulate, manage or control the risks of LMOs resulting from biotechnology, and of Article 19 on the handling of biotechnology and distribution of its benefits, became extremely fractious, with Parties arguing for different understandings of the compromise reached.
Minimal text was then developed, with several brackets remaining. This was subsequently sent to the Ministers to resolve, with the resulting President’s text that was eventually adopted. Target 17 finally reads: “Establish, strengthen capacity for, and implement in all countries in biosafety measures as set out in Article 8(g) of the Convention on Biological Diversity and measures for the handling of biotechnology and distribution of its benefits as set out in Article 19 of the Convention.”
This is really a wasted opportunity for what was purported to be a “missing” Aichi Biodiversity Target, and a lost chance to take forward the discussions on biosafety in the context of halting and reversing biodiversity loss.
The same blinded approach was also prevalent throughout the GBF – with a strong focus on science, technology and innovation, without the balance of technology assessment, the benefit of horizon scanning and monitoring, as well as the side-lining of precaution. This may leave Parties hampered in their ability to be able to properly identify and assess new technologies, including synthetic biology and new genetic techniques, whose developments are far outstripping regulatory abilities.
Nonetheless, the provisions of the Convention, including the precautionary approach as set out in its preamble, as well as Article 8(g) and Article 19, which set out the biosafety obligations that CBD Parties have, remain sine qua non. In addition, obligations under Article 7 (identification and monitoring), and Article 14 (impact assessment) of the Convention relate directly to the task of horizon scanning, monitoring and assessment.
As defined under the CBD, “LMOs resulting from biotechnology” would also include those resulting from synthetic biology and new genetic techniques such as genome editing. Furthermore, in so far as LMOs resulting from synthetic biology and other new genetic techniques meet the definition of LMOs under the Cartagena Protocol, they would also be regulated as such.
As made clear in the Implementation Plan for the Cartagena Protocol on Biosafety and in the Capacity-building action plan for the Cartagena Protocol on Biosafety and the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress, both of which were adopted by COPMOP10 in Montreal, “where organisms developed through new technologies constitute ‘living modified organisms’ as defined in the Protocol, these organisms are addressed” in the Plans concerned.
Other decisions adopted by Parties to the Cartagena Protocol, including that on risk assessment and risk management, and on detection and identification of LMOs, also address new genetic techniques.
In the decision on risk assessment and risk management, Parties agreed to develop guidance materials to support the risk assessment of LMOs containing engineered gene drives. They established an Ad Hoc Technical Expert Group on Risk Assessment to do so.
The decision recalls both the importance of the precautionary approach and notes the existing guidance on the assessment of socio-economic considerations. While it decided not to proceed, at this stage, with the development of additional guidance materials regarding living modified fish, it agreed to consider further guidance on living modified fish at COPMOP11 in 2024. This has been a long-standing demand of Parties.
Moreover, the decision on detection and identification specifically calls on Parties and relevant organizations to submit information on their experience with detecting newly developed and unauthorized LMOs. This information should be taken into account by SBSTTA, which will make a recommendation to COPMOP11 with regard to the need to update the training manual on the detection and identification of LMOs.
This therefore opens the door for further work on new detection techniques, and on the detection and identification of newly developed LMOs, which could include gene edited organisms and other LMOs resulting from synthetic biology and new genetic techniques.
Taken together with the further work on synthetic biology agreed under the CBD, these decisions in sum continue to address the new technologies, despite the best efforts of opponents to thwart this important work. +