TWN Info Service on Biosafety and Biodiversity/Traditional Knowledge
21 November 2025
Third World Network
www.twn.my
Discussions on risk assessment of living modified organisms stuck in a loop
London, 20 Nov (Lim Li Ching) – The risk assessment of living modified organisms (LMOs) is a central obligation of Parties to the Cartagena Protocol on Biosafety. At a subsidiary body meeting of the Convention on Biological Diversity (CBD), which also serves the Protocol, a small minority of Parties blocked progress on the development of further guidance materials on risk assessment.
The Parties were convening at the twenty-seventh meeting of the Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA 27), from 24-27 October 2025, in Panama City. Ironically, the host country, Panama, was the main opposer of any further guidance materials and the establishment of an ad hoc technical expert group (AHTEG) to conduct the work.
This impasse may leave Parties, particularly from developing countries, ill-equipped to face the increasing challenges posed by LMOs. As modern biotechnology expands into new and riskier domains, LMOs now encompass a wider range of species, traits and applications, with greater potential for uncontrollable spread and unpredictable effects. However, risk assessment methods were largely designed for terrestrial crop species, resulting in significant knowledge gaps and uncertainties with new LMOs.
Additional guidance materials would help Parties to better assess the risks that LMOs may pose. Since they are voluntary in nature, it would be a shame for any Party to stand in the way of others that would like such guidance materials.
The requests for additional guidance materials by Parties have been made over numerous years. In decision CP-9/13 of 2018, the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety (COP-MOP) established a process for the identification and prioritisation of specific issues regarding risk assessment of LMOs, with a view to developing further guidance, in accordance with criteria set out in Annex I of that decision.
[Since then, guidance materials have been developed on risk assessment of LMOs containing engineered gene drives (EGD-LMOs). However, observers fear that those materials are not precautionary enough, given the wide-ranging impacts that EGD-LMOs may have, due to their self-spreading nature. Earlier guidance on risk assessment of LMOs and monitoring in the context of risk assessment was taken note of by Parties, but faced opposition from biotech-friendly countries.]
In decision CP-11/7 of 2024, Parties were invited to submit detailed information on their needs and priorities for further guidance materials. The Open-ended Online Forum on Risk Assessment and Risk Management was extended to support the analysis. An AHTEG analysed the information and prepared a list of prioritised topics on which further guidance materials on risk assessment may be needed.
The AHTEG concluded that seven topics fulfilled all the criteria set out in Annex I of decision CP-9/13 to warrant further guidance on risk assessment. Four topics were prioritised for risk assessment guidance materials: LM fish, LM microorganisms, LM algae, and LMOs expressing genome editing machinery for pest or pathogen control.
Three topics were prioritised for the development of “technical notes”, which the AHTEG proposed as supplements to existing guidance materials, to support more specific risk assessment considerations. These are: long-term and cumulative effects of genetic constructs and LMOs; use of LMOs in centres of origin and in traditional agricultural systems; and operationalising protection goals into relevant risk assessment endpoints.
When the issue was considered at the plenary of SBSTTA 27, many Parties, including those from Africa, Asia, Latin America and Europe, supported the development of further guidance materials on risk assessment. Some, like Egypt and Mexico, welcomed guidance materials for all the topics suggested by the AHTEG.
Others highlighted their priorities. For example, Morocco and Norway were in favour of guidance on LM fish, while Switzerland preferred guidance on both LM fish and LM microbes. India proposed a focus on LM microbes and LM algae.
Guatemala and Mexico were strongly in support of a technical note on the use of LMOs in centres of origin and in traditional agricultural systems, given their national contexts as centres of origin and centres of genetic diversity for specific crop species. Guatemala even proposed that this be upgraded from a technical note to guidance material.
Several Parties, largely from Europe, suggested reducing the number of guidance materials to be developed over the intersessional period, to reduce the workload on the AHTEG. They were flexible as to which topics are chosen. Finland suggested that remaining topics could be decided at COP-MOP 13, while Austria and Hungary proposed the elaboration of a work programme or plan on how to cover the remaining topics.
On the other hand, a minority of Parties, including New Zealand, Brazil and Panama, were not in favour of the development of further guidance materials on risk assessment. Panama was also opposed to the establishment of a new AHTEG to carry out further work. Brazil feared that a proliferation of new guidance materials would create non-tariff barriers, but was open to the establishment of a new AHTEG provided its value could be clearly demonstrated.
Parties from Africa differed in their positions. Some, like Egypt and Morocco, supported the development of guidance materials. Others were ambivalent to the development of new guidance materials, with Parties such as Uganda, Zimbabwe and Namibia calling for a focus on capacity building instead.
South Africa preferred a technical series on the issue of operationalising protection goals into relevant risk assessment endpoints, and called for activities that further the relevant goals of the Implementation Plan and Capacity-building Action Plan of the Protocol relating to risk assessment and risk management.
Malawi expressed reservations on the development of new guidance materials, but called for technical notes on two topics: on long-term and cumulative effects of genetic constructs and LMOs, and operationalising protection goals into relevant risk assessment endpoints.
Given the divergence of views, the SBSTTA Chair (Jean Bruno Mikissa from Gabon) established a Contact Group on the matter, co-chaired by Martha Kandawa-Schulz (Namibia) and Werner Schenkel (Germany). Its mandate was to prepare a recommendation for consideration by COP-MOP 12, including areas where further guidance might be required.
The Contact Group met twice. A non-paper was produced by the co-chairs, which formed the basis of negotiations. As negotiations proceeded, it became clear that the Parties opposed to new guidance were adamant on maintaining this position. They instead pointed to capacity building, which to them was a greater need.
However, Parties in favour of developing new guidance emphasised that the two issues were not mutually exclusive, and proposed that the draft decision address both in a balanced way. On the basis of this understanding, Parties made proposals and text suggestions for the two issues, with differing opinions as to how many and what topics would be selected.
Some Parties also reminded the group that no matter what topics are chosen, the remaining topics should not be forgotten, given that the AHTEG had already analysed them and determined that they meet the criteria laid out in Annex 1 of decision CP-9/13.
At the second meeting of the Contact Group, the co-chairs conveyed the SBSTTA Chair’s instruction to focus on the guidance materials, and not capacity building, as the latter is the mandate of the Subsidiary Body on Implementation (SBI) rather than the SBSTTA.
Questions surfaced with regard to the difference between “guidance materials” and “technical notes”, the latter being something the AHTEG had proposed. Some Parties were wary of the introduction of new ideas, while others felt that the draft decision could focus generally on guidance materials as per the COP-MOP mandate, with details being specified in the terms of reference for the AHTEG.
On the issue of the number of topics, the co-chairs put forward a proposal that a maximum of two additional guidance materials would be developed. However, as there was no agreement on which topics would be selected, or on “technical notes”, Parties proposed to leave the decision to the COP-MOP.
Therefore, all the seven topics (as proposed by the AHTEG) were listed in brackets, as possible topics for which “additional voluntary guidance materials in accordance with annex III to the Cartagena Protocol on Biosafety” would be developed, “while avoiding duplication with and, where appropriate, supplementing existing guidance materials”.
Nonetheless, one Party maintained its insistence that it could not support the development of any new guidance materials, “full stop”. Neither could it support the establishment of an AHTEG. As such, paragraphs referring to guidance materials and the AHTEG were all bracketed in their entirety.
Another issue of contention was whether to refer to the guidance materials on EGD-LMOs, which was published in Biosafety Technical Series 7 by the CBD Secretariat, as a basis for capacity building. Some Parties were adamant that those guidance materials be the sole basis, others were of the view that capacity building needed to draw on a broad range of materials. Two alternative paragraphs were therefore proposed, reflecting both views, and in brackets.
A Friends of the co-chairs group was established to work on the Annex containing the terms of reference of the AHTEG. Chaired by Finland, it included Austria, Denmark, Egypt, Finland, Guatemala, Hungary, India, Malawi, New Zealand, Norway, Panama and Zimbabwe.
The conference room paper (CRP) was considered in the evening of the last day of the meeting. The SBSTTA Chair suggested that due to the late hour, and the fact that the CRP was a product of the Contact Group’s deliberations, the CRP be adopted as a whole.
Finland and Hungary intervened to explain that the Friends group developed an alternative text for the paragraph in the Annex focusing on “technical notes” to try to better explain what they are. As this alternative text was not reflected in the CRP, they suggested that it be included in the document, since the whole Annex is in brackets.
Brazil, Togo and Panama raised some concerns with regard to the late introduction of the text. That proposal is now reflected in brackets, with the whole list of seven topics identified by the AHTEG, alongside the original text on technical notes, for the COP-MOP to consider.
Essentially, everything remains on the table as options – whether or not to develop guidance materials on risk assessment, whether or not to establish an AHTEG, the nature and scope of such materials, and the topics that could be selected.
Parties to the Cartagena Protocol will thus have to reflect carefully on the issues, so that a decision on risk assessment can be taken at COP-MOP 12, and not risk repeating the discussions. That decision should be one that is able to equip Parties to robustly assess the risks posed by LMOs and new developments, in accordance with the precautionary approach.+