TWN Briefings for UN Biodiversity Conference #3
13th Conference of the Parties to the Convention on Biological Diversity
8th Conference of the Parties serving as the Meeting of the Parties to the Cartagena Protocol on Biosafety
2nd Conference of the Parties serving as the Meeting of the Parties to the Nagoya Protocol on Access and Benefit-Sharing
4-17 December 2016, Cancún, Mexico
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Synthetic biology and risk assessment
Lim Li Ching, Third World Network
Coordinated approach needed
Synthetic biology is bringing about a convergence of the agendas of the Convention on Biological Diversity (CBD) and the Cartagena Protocol on Biosafety, around the topic of risk assessment. Risk assessment is the cornerstone of the Cartagena Protocol, as the Protocolrecognises the fact that living modified organisms (LMOs) may have biodiversity and human health impacts, and that these impacts need to be risk assessed.
In 2014, the COP-MOP of the Cartagena Protocol recommended to the CBD COP a coordinated approach among the two Governing Bodies on the issue of synthetic biology, taking into account that the provisions of the Cartagena Protocol may also apply to living organisms resulting from synthetic biology. The COP meanwhile urged a precautionary approach, and called for the establishment or putting in place of effective risk assessment and management procedures and/or regulatory systems to regulate environmental release of any organisms, components or products resulting from synthetic biology techniques.
The COP also established an Ad Hoc Technical Expert Group (AHTEG) on Synthetic Biology, which met in September 2015. The AHTEG recommended to the COP to “urge Parties to address synthetic biology in a coordinated manner within the context of the objectives of the Convention and its Protocols, particularly by tapping into existing processes, such as the AHTEG on Risk Assessment and Risk Management”.
Updating and adapting risk assessment methodologies
The role of the Cartagena Protocol, and its AHETG on Risk Assessment and Risk Management, in relation to synthetic biology becomes even more important with the following considerations (also contained in the COP 13 draft decision on synthetic biology):
- The conclusion of the AHTEG on Synthetic Biology that living organisms developed through current applications of synthetic biology, or that are currently in the advanced stages of research and development, are similar to living modified organisms as defined in the Cartagena Protocol.
- The general principles and methodologies for risk assessment under the Cartagena Protocol and existing biosafety frameworks provide a good basis for risk assessment regarding living organisms developed through current applications of synthetic biology, or that are currently in the advanced stages of research and development, but such methodologies may need to be updated and adapted for current and future developments and applications of synthetic biology.
The Cartagena Protocol therefore has an important role to play in providing Parties with the tools to deal with the risks posed by living organisms – and to a limited extent – products and components, of synthetic biology. Importantly, while existing risk assessment methodologies can be applied as a basis to assess the risks of living organisms developed through current and near future applications of synthetic biology, these methodologies still need to be updated and adapted, to ensure that the risks are adequately assessed. Some CBD Parties have already acknowledged that there could be specific challenges and limitations with regard to risk assessment principles and methodologies that are currently applied to evaluate LMOs, given that synthetic biology is likely to lead to the development of organisms that will differ fundamentally from naturally occurring ones.
The draft decision on synthetic biology that is being considered by COP13 therefore encouragescooperation in updating and adapting current methodologies for risk assessment of LMOs to organisms resulting from synthetic biology. It also invites submissions to the Executive Secretary on this issue, as well as on experiences in conducting risk assessments of organisms, components and products of synthetic biology, including any challenges encountered, lessons learned and implications for risk assessment frameworks.
Guidance on risk assessment
In the meantime, the AHTEG on Risk Assessment and Risk Management under the Cartagena Protocol, in response to its terms of reference to take into account the previously prioritized topics for the development of further guidance, decided to recommend to the COP-MOP the development of additional guidance on risk assessment of LMOs developed through synthetic biology. To facilitate this, the AHTEG prepared an outline of guidance on “Risk Assessment of LMOs developed through synthetic biology”.
The outline recognises that synthetic biology may lead to the development of LMOs containing new significantly different features from those in the original organism or from organisms existing in nature. It lists out six considerations specific to risk assessment of synthetic biology:
(a) The choice of comparators – The comparative approach may not be suitable or sufficient for the risk assessment of LMOs developed through synthetic biology in cases where the depth or kind of intervention result in LMOs whose genomes differ substantially from those in existing organisms. Risk assessors need to carefully consider the lack of suitable comparators or the need to use multiple comparators.
(b) LMOs being developed faster and with an increased number of modified traits – Synthetic biology may lead to a faster development of LMOs through the use of automation and to more numerous and complex changes and novel traits, making the evaluation of their overall risk more complex. As such, current risk assessment methodologies may not be adequate and may need to be adapted.
(c) Potential to alter wild populations, species and ecosystems – Tools that support synthetic biology, such as high throughput DNA sequencing and computational analyses, may make it easier to develop LMOs containing ‘gene drive’ systems. Gene drives may cause irreversible adverse effects on beneficial organisms and ecosystems. Risk assessment methodologies may need to be adapted in order to fully assess the potential adverse effects. (It should be noted, however, that civil society is calling for a moratorium on the applied research, development and release of genetically engineered gene drives, because of the lack of international governance on the issue and the serious ecological and societal effects a release could introduce.)
(d) LM microorganisms resulting from synthetic biology – Some applications of synthetic biology aim at developing microorganisms for intentional release into the environment. Current risk assessment methodologies may not be adequate to assess environmental risks of complex LM microorganisms developed through synthetic biology and therefore may need to be adapted.
(e) Increased accessibility to techniques of synthetic biology – In some countries, synthetic biology approaches are becoming more accessible and easy to use by the general public. LMOs developed by ‘citizen scientists’ may escape containment and be introduced into the environment. Considerations of the risks of such LMOs may require adopting measures to ensure the safe handling and use of such LMOs.
(f) Detection of LMOs developed through synthetic biology using genome editing –
Synthetic biology may use genome editing to modify organisms, which may create multiple simultaneous changes across the genome. The resulting LMOs may not be easily characterized or detected through methods that are currently in use.
In order to advance the work on risk assessment of synthetic biology, it is therefore crucial that Parties at COP-MOP8 establish a process for the development of guidance on the basis of the outline developed, in coordination with relevant processes under the CBD. In order to do so, Parties need to also extend two inter-sessional processes dealing with risk assessment under the Protocol – the Open-ended Online Expert Forum and the AHTEG on Risk Assessment and Management – to develop the guidance.