Virtual Informal Session of SBSTTA-24 Considers Synthetic Biology and LMO Risk Assessment



Dear Friends and Colleagues

Virtual informal session of SBSTTA-24 considers synthetic biology and LMO risk assessment

The CBD’s Subsidiary Body on Scientific, Technical and Technological advice is currently holding a virtual informal session (17-19 and 24-26 February 2021). This is not a formal meeting or a virtual negotiation, as there has been no agreement yet on moving forward in this manner. Some developing countries are concerned that formal virtual negotiations will be inequitable, disadvantaging poorer countries with limited capacity and resources and without good internet and technical capability, while posing challenges for regional and other coordination.

Among the agenda items discussed were that of synthetic biology, and risk assessment and risk management of LMOs. The issue of gene drive organisms features prominently in both these agenda items, with civil society calling for a moratorium on environmental releases of such organisms.  Switzerland, a Party to both the CBD and the Cartagena Protocol on Biosafety, also stated that “as long as risks and benefits cannot be correctly assessed, as long as risk management measures cannot be correctly set into force, it is necessary to refrain [from] releasing living modified organisms containing gene drive to avoid irreversible effects to the biodiversity and unintended transboundary movements”.

The Ad Hoc Technical Expert Group (AHTEG) on Synthetic Biology recommended a process for broad and regular horizon scanning, monitoring and assessment of the most recent technological developments, the necessity of which was agreed by Parties to the CBD in 2018, and the establishment of a Multidisciplinary Technical Expert Group to support this process. The AHTEG on Risk Assessment and Risk Management recommended the development of guidance for the risk assessment on living modified organisms containing engineered gene drives. Both these recommendations were largely supported by Parties to the CBD and Cartagena Protocol, respectively.

We are pleased to highlight below TWN’s statements on the two agenda items.


With best wishes,

Third World Network
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Item 1: Agenda Item 4 (Synthetic Biology)

 Statement by Third World Network

We are in unprecedented times, and the urgency to protect biodiversity and share the benefits equitably has never been greater. While we appreciate the opportunity to exchange views in this informal meeting, we do not believe that it would be equitable to hold formal virtual negotiations due to the digital divide, disadvantaging developing countries with limited capacity and without good internet and technical capability.

What is needed urgently is for renewed commitment by Parties to implement their obligations under the CBD. In this regard, the discussions on synthetic biology are clearly urgent, and should not be postponed by circular arguments of whether it is a new and emerging issue. It clearly is.

Synthetic biology technologies are intensifying in scale and depth, resulting in increased risks to biodiversity and human health. For example, applications that aim to perform population-wide engineering, and technologies to directly engineer organisms in the environment, are in development.

We urgently need a process for broad and regular horizon scanning, monitoring and assessment of the most recent technological developments, including of concrete applications of genome editing if they relate to synthetic biology.

The Multidisciplinary Technical Expert Group has to fully incorporate the multidisciplinary expertise needed to cover the increasing diversity of applications that are expanding beyond agriculture, into human health, conservation, as well as gain-of-function experiments and reconstruction of pathogenic viruses. Such trends also emphasise the urgent need to conduct technology assessments to adequately assess the human, animal and plant health, socioeconomic, cultural and ethical impacts. There must be effective participation of indigenous peoples and local communities in the Multidisciplinary Technical Expert Group.

The free, prior and informed consent of indigenous peoples and local communities must be obtained before releasing any synthetic biology organisms, components or products that may impact their traditional knowledge, innovation, practices, livelihood and use of land, resources and water.

We are extremely concerned by near future plans for release of organisms containing engineered gene drives. Such organisms, designed to spread indefinitely, have the potential to result in an irreversible impact on biodiversity. There is a need to apply the precautionary principle. We call for an immediate global moratorium on the release, including experimental release, into the environment of such organisms.

At the same time research and development continues in the laboratory. Accidental escape could result in indefinite transmission of some of these technologies. There has to be stringent contained use regulations at national levels. In particular, we need international contained use regulations for organisms containing engineered gene drives, as these do not yet exist.

Finally, further work on detection, identification and monitoring of organisms, components and products of synthetic biology, is necessary. In particular, to identify organisms for which current tools are insufficient, and to develop additional detection, identification and monitoring tools.


Item 2: Agenda Item 5 (Risk assessment and risk management)

Statement by the CBD Alliance, made by Third World Network

Thank you, Chair. I am making this statement on behalf of the CBD Alliance, which gathers a diverse range of views and proposals from civil society.

There are fundamental risk assessment challenges for living modified fish, as listed in the AHTEG report. The modification of wild organisms such as fish introduces the potential for next-generation effects as the organisms persist over time and space. Such increases in spatial and temporal complexities, along with fundamental knowledge gaps, as acknowledged by the AHTEG, increases uncertainty.

We therefore agree with the AHTEG members who saw a clear need and rationale for guidance on risk assessment to be developed on living modified fish. We support the intervention of Mexico in this regard.

The AHTEG also acknowledged that LMOs containing engineered gene drives pose specific challenges to risk assessment due to their invasive design to spread and persist in wild populations. This presents a potentially irreversible threat to biodiversity, which is compounded by the inability to control or recall a gene drive after release.

Gene drives have potential next-generation effects. The inclusion of genetic engineering machinery that will continue to perform genetic engineering at every generation, in genetically diverse wild populations raises specific challenges due to the potential for unintended effects to occur over time, as acknowledged by the AHTEG. Evolutionary processes make it possible to turn events with a low probability of ever happening into events that are likely to happen. Inherent non-knowledge can, thereby, increase to such an extent that the conclusiveness of risk assessment is severely affected.

We support the conclusion of the AHTEG that current risk assessment frameworks are insufficient for LMOs containing engineered gene drives. Given their invasive nature and inability to control, recall or reverse them, we call for an immediate global moratorium on the release, including experimental release, into the environment of such organisms.

Any guidance on risk assessment has to fully operationalize the precautionary principle to protect against the potential irreversible damage to biodiversity and acknowledge the serious challenges to risk assessment for LMOs containing engineered gene drives. If it is likely that such organisms can escape spatio-temporal controllability, the risk assessment cannot be sufficiently reliable because it is not conclusive. Under such circumstances, the environmental release of such organisms is not compatible with the precautionary principle.

The work of the AHTEG developing guidance on risk assessment for LMOs containing engineered gene drives must build on and complement existing CBD decisions on organisms containing engeneered gene drives, inter alia, applying a precautionary approach, obtaining the free, prior and informed consent of potentially affected indigenous peoples and local communities, and assessing the socioeconomic, cultural and ethical impacts.

Furthermore, we remind all of the procedure for avoiding or managing conflicts of interest, adopted by Parties and as contained in COP Decision 14/33 and COPMOP Decision 9/10 and the necessity of applying these procedures to the AHTEG developing guidance. It is also essential that there is full, meaningful and effective participation of IPLCs in the AHTEG.

Finally, given the rapid technology developments, including of LMOs produced through genome editing, it is urgent that additional guidance materials on risk assessment continue to be developed, taking into account priorities identified by Parties.

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