Major Differences Vex Discussions on Assessment of New Genetic Technologies

TWN Info Service on Biosafety and Biodiversity and TK
2 July 2021
Third World Network

Major differences vex discussions on assessment of new genetic technologies

London, 1 July (Lim Li Ching*) – Discussions on the assessment of new genetic technologies, such as synthetic biology and organisms containing engineered gene drives, at the Convention on Biological Diversity’s (CBD) Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA) have brought to light major differences.

Clear divisions emerged between Parties that grow and export genetically modified crops, such as Brazil and Argentina, and other Parties that tend to take more precautionary approaches to living modified organisms (LMOs) and new genetic technologies, such as those from Europe. Argentina is not a Party to the Cartagena Protocol on Biosafety, which is a Protocol to the CBD.

The CBD held formal virtual sessions of its Subsidiary Bodies (SBSTTA and the Subsidiary Body on Implementation, SBI) over a six-week period, from 3 May to 13 June 2021. These meetings had been postponed from 2020, and informal sessions of the Subsidiary Bodies were also held in February and March 2021.

The COVID-19 pandemic has made in-person meetings currently impossible. Despite the strong reservations of many civil society organisations and developing countries with regard to formal virtual negotiations, the meetings went ahead virtually. These concerns have proven to be real, and even more inequitable and unsatisfactory than anticipated, with persistent technical connectivity and structural barriers to effective participation.

The virtual process was clearly not sufficient to bring Parties to consensus over contentious issues, with many documents now containing a proliferation of square brackets, indicating non-consensus on the text between brackets.

While SBSTTA-24 was able to proceed to the stage of adopting next to final documents (known as conference room papers, CRPs) on some agenda items, including that on synthetic biology, and on risk assessment and risk management (of LMOs), these remain heavily bracketed.

No final documents were adopted; instead these will be discussed at a later resumed SBSTTA-24 session, which will be held in-person. There is no clarity yet on when the resumed session will happen.

The main issue of contention in the discussion on synthetic biology was with regard to the establishment of a broad and regular horizon scanning, monitoring and assessment process of the most recent technological developments.

Parties to the CBD had already agreed at their last meeting in 2018 that such a process was needed. This would allow for the rapid and fast-paced developments in the field of synthetic biology to be reviewed, and their potential adverse effects anticipated, monitored and assessed.

The overwhelming majority of Parties therefore supported the establishment of the process, with the notable exception of Brazil, which felt that this was premature, citing the still unresolved issue of whether synthetic biology is considered a “new and emerging issue” under the Convention.

However, there already has been serious work under the CBD on synthetic biology for many years, and therefore many Parties felt that the horizon scanning, monitoring and assessment process should be established and implemented without delay. This is also urgent given the rapid technological developments and the need to apply a precautionary approach, which is a key underlying principle of the CBD.

The Ad Hoc Technical Expert Group (AHTEG) on Synthetic Biology, which met in June 2019, had conducted an analysis on the relationship between synthetic biology and the criteria for new and emerging issues, which was put before Parties to assist them in considering whether synthetic biology should be a new and emerging issue.

Given the divergence of views among Parties on this issue during the initial plenary session, SBSTTA Chair Hesiquio Benitez Diaz (Mexico) established a Friends of the Chair group comprising Argentina, Australia, Austria, Brazil, Canada, Ethiopia, the European Union, Finland, Japan, Mexico and Norway, and facilitated by Helena Brown (Antigua and Barbuda).

The Friends of the Chair group could not reach consensus, and came back with text that retains all options on the table: deciding not to require further analysis on whether synthetic biology is a new and emerging issue; keeping the Convention’s work on synthetic biology under review; and recognizing that synthetic biology has not been determined to be, or not to be, a new and emerging issue.

In order to try and resolve the difficult issues related to horizon scanning, monitoring and assessment, a Contact Group was established, co-chaired by Ntakadzeni Tshidada (South Africa) and Werner Schenkel (Germany). However, achieving consensus proved elusive under the limited time available in a virtual setting, and the lack of inclusive in-person participation by Parties necessary to facilitate trust and consensus building.

The AHTEG on Synthetic Biology had been tasked to recommend options for the horizon scanning, monitoring and assessment process. It had also taken stock of new technological developments that could inform the process, including the consideration of concrete applications of genome editing if they relate to synthetic biology. The AHTEG had grouped these developments into trends, such as increased development of technologies that genetically modify organisms directly in the field (for example, gene drives), increased sophistication of methods (for example, new genome editing techniques), and transient modification of organisms (for example, through the use of synthetic double-stranded RNA molecules).

While the AHTEG had recommended the establishment of a Multidisciplinary Technical Expert Group on Synthetic Biology to carry out the horizon scanning, monitoring and assessment process, at SBSTTA-24, disagreement abounded over its establishment and its form. Some Parties feared that the Multidisciplinary Technical Expert Group would become a standing process, and were more in favour of an AHTEG, which usually has a time-limited mandate and is established only when there is a specific need.

Parties eventually landed on a “multidisciplinary Ad Hoc Technical Expert Group”, although whether one should be established or not is still not agreed upon. Some Parties wanted SBSTTA to be the body that undertakes the horizon scanning, monitoring and assessment process, rather than the multidisciplinary AHTEG. However, the Parties in favour of the latter felt that SBSTTA should not be overburdened and that the specialist task would be better suited for a smaller group with the necessary expertise.

Text referring to the multidisciplinary AHTEG is therefore all in square brackets, including the terms of reference for the group. Text referring to SBSTTA carrying out the process is presented as an alternative.

The other major point of contention was the period of time the horizon scanning, monitoring and assessment process should be carried out for. Some Parties wanted the work carried out over one intersessional period, others over two intersessional periods. There was also disagreement as to whether or not to extend this initial process once it has completed.

The continuing need for the multidisciplinary AHTEG is expected to be assessed in light of the overall assessment of the effectiveness of the process. Therefore, a review has been built in; however, there is no consensus yet on how often this should happen, as that is dependent on how long the Parties decide to establish the process for.

In addition to the terms of reference for the multidisciplinary AHTEG being bracketed in their entirety, specific tasks for the group were also not agreed upon. These disagreements include reference to carrying out an actual technology assessment; identification of a methodology for the assessment of information compiled; identification of capacity building, technology transfer and knowledge sharing needs; and evaluation of the availability of tools for detection, identification and monitoring.

The Contact Group did not discuss further paragraphs in the terms of reference related to the composition of the multidisciplinary AHTEG nor was there time at the plenary session to do so. Current text indicates that it should include expertise from a broad range of disciplines, as well as interdisciplinary and intercultural expertise, and indigenous peoples and local communities (IPLCs). There is also text obligating the application of the procedure adopted by Parties for avoiding or managing conflicts of interest in expert groups.

These elements are essential to ensuring that the full spectrum of the potential impacts of synthetic biology on biodiversity, as well as on human, animal and plant health, and cultural and socioeconomic issues are identified, assessed and monitored, and in a manner that is independent, particularly because of the vested interests that some experts may have.

SBSTTA is meant to review the outcomes of the horizon scanning, monitoring and assessment process and make recommendations on technological developments of synthetic biology and their impacts. However, the issue of whether the scope of impacts should include social, economic and cultural impacts as well as related ethical issues, remains unresolved.

This is actually a regression, because the decision on synthetic biology from 2016 had already invited Parties to take into account, as appropriate, socio-economic, cultural and ethical considerations.

While the discussions on synthetic biology clearly continue to be relevant and applicable to the controversial issue of organisms containing engineered gene drives, preambular text recalling paragraphs 9 to 11 of decision 14/19 and calling on Parties to apply the precautionary approach was bracketed by Argentina in the plenary session considering the CRP on synthetic biology.

Those paragraphs in the decision from 2018 laid down strict and precautionary conditions for any introduction of organisms containing engineered gene drives into the environment, including for experimental releases and for research and development purposes.

Argentina cited the problems that its delegation had with internet connectivity and its inability to participate when the preambular paragraph was being discussed by the plenary. It asked for the paragraph to be bracketed in its entirety so as to not create the false impression that the paragraph had been agreed.

Paragraph 9 of decision 14/19 also recognized that specific guidance for organisms containing engineered gene drives may be useful. It footnoted the process set forth under the Cartagena Protocol on Biosafety, whereby Parties to the Protocol are to consider the need for specific guidance on risk assessment of LMOs containing engineered gene drives at their tenth meeting.

These discussions at SBSTTA-24, under the agenda item on risk assessment and risk management, saw many Parties to the Cartagena Protocol agreeing that guidance on risk assessment of LMOs containing engineered gene drives should be developed.

A Contact Group was established to further the discussion on the specifics of the terms of reference for the AHTEG on Risk Assessment to be set up to develop the guidance, and the process by which it would do so. The Contact Group was co-chaired by the same co-chairs as the Contact Group on synthetic biology, Ntakadzeni Tshidada (South Africa) and Werner Schenkel (Germany).

Two major areas of disagreement emerged. The first was around the scope of the guidance: whether the guidance should solely focus on gene drive mosquitoes, as preferred by some Parties, or should also explore general considerations.

The latter is viewed as necessary to understand the full spectrum of potential negative impacts and risks of organisms containing engineered gene drives. Additionally, while gene drive mosquitoes are likely to be the first application of the technology, they are not the only gene drive organisms in current research and development.

Further, Parties disagreed as to whether the previous work of the AHTEG on Risk Assessment including its identification of challenges to risk assessment of organisms containing engineered gene drives, should also be taken into consideration. They also disagreed as to whether the guidance should take into account human health, environmental and socioeconomic impacts as well as traditional knowledge and the value of biodiversity to IPLCs.

The second major area of disagreement revolved around a proposal by some developed country Parties for a smaller group of experts to develop an outline and produce a first draft of the guidance. There was disquiet with this proposal, given the lack of clarity on the composition of such a group, the criteria for selection, where the experts should be drawn from and what range of expertise they would have.

The Contact Group also discussed the issue of guidance on risk assessment of living modified (LM) fish. This was one of the areas that Parties to the Cartagena Protocol had earlier decided guidance should be considered for. However at the (virtual) meeting of the AHTEG on Risk Assessment in 2020, there were divergent views as to whether guidance for LM fish was necessary.

At the initial SBSTTA-24 plenary session, several Parties – Belarus, Indonesia, South Korea and Mexico – called for guidance for LM fish to be developed, arguing that LM fish pose transboundary and other risks such as potential food web and next-generation effects, as well as have socioeconomic implications.

At the Contact Group, while Parties could agree to the promotion of international cooperation, knowledge sharing and capacity-building on risk assessment of LM fish, they could not agree on the issue of developing guidance.

Text introduced by a Party calling for the consideration of guidance on risk assessment of LM fish at the eleventh meeting of the Parties to the Protocol could not be agreed upon, and so remains in square brackets.

Parties were however able to agree on a process for identification and prioritization for further guidance materials on specific topics of risk assessment of LMOs, with a view to considering additional issues for which guidance materials on risk assessment may be needed. This would be important to keep pace with the developments of new LMOs and to ensure that their risk assessment remains relevant and robust.

When the CRP on risk assessment and risk management was brought back to the plenary for discussion, the SBSTTA Chair urged for its adoption as a whole, given that the time remaining for the SBSTTA plenary to adopt CRPs was very limited.

Parties agreed to this proposal and adopted the CRP with brackets remaining on the contested issues. Nonetheless, it should be noted that the Contact Group did not discuss all the paragraphs, neither was there a chance to discuss these when the CRP was brought to the plenary.

The final documents for the agenda items on synthetic biology, and for risk assessment and risk management, will therefore continue to be discussed at the resumed session of SBSTTA-24, which will be a face-to-face meeting. How, when and where this session will be held remain uncertain, as is the fate of the final decisions on these important issues. +

(*With inputs from Lim Li Lin)

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