TWN Info Service on Biodiversity and Traditional Knowledge (May22/01)
5 May 2022
Third World Network

Dear friends and colleagues

Technical series on LMO detection and identification, and synthetic biology

The Secretariat of the Convention on Biological Diversity (CBD) has recently published two technical series relevant to discussions on living modified organisms (LMOs) and synthetic biology. These are “Biosafety Technical Series 05: Training Manual on the Detection and Identification of Living Modified Organisms in the Context of the Cartagena Protocol on Biosafety” and “CBD Technical Series 100: Synthetic Biology”.

These documents were developed pursuant to requests from Parties to the Cartagena Protocol on Biosafety and the CBD, respectively. These documents will be relevant to their discussions, including in the context of Article 17 of the Protocol (Unintentional transboundary movements and emergency measures), and on synthetic biology under the CBD. The latter discussions are currently centred on the proposed establishment of a broad and regular horizon scanning, monitoring and assessment process of the most recent technological developments.

Third World Network was invited to be a respondent at the Webinar on Synthetic Biology, held to launch the Technical Series on Synthetic Biology. We are pleased to share our intervention below.

Further information, including the documents and the recordings of the webinars, is available here:
https://bch.cbd.int/protocol/training_manual.shtml
https://bch.cbd.int/synbio/open-ended/discussion/Technical_Series.shtml

 With best wishes,
Third World Network

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Intervention by TWN at the Webinar: Launch of CBD Technical Series No. 100: Synthetic Biology, 27 April 2022

Thank you for inviting me to provide some reflections on the updated document.

The first point to make is that robust governance will not create an overly complex or stringent environment that slows development in the field. Rather, it is the lack of governance that will actually do that. Governance based on the precautionary approach, that takes into account the rights of indigenous peoples and local communities, is essential for ensuring that development of the field proceeds in a sustainable manner and is supportive of environmental and social considerations.

Second, we reaffirm the document’s assertion on the need to “expand the focus of governance beyond biosafety, human health and the biophys­ical environment to a more holistic approach that also encompasses social impacts, ethical princi­ples, and elements of social justice”. This is congruent with decisions on synthetic biology already adopted by CBD Parties. These are necessary elements for technology assessment, and efforts are needed to further provide the tools for Parties to be able to adequately assess these technologies and their impacts.

Third, the assertion of increasing economic value of synthetic biology markets is not as relevant as providing the basis for anticipating the potential adverse effects of synthetic biology. In order to do this, technology horizon scanning, monitoring and assessment is critical, and the elaboration in the document of the applications in near term research and commercialization and their potential impacts can be a foundation for such a process. We concur with the key message that such horizon scanning is important.

Fourth, the catergorization of products and applications is useful, but a word of caution – the assessment of impacts should not be solely confined to such categories or be based on the assumptions that might apply, because there is always the possibility that these categories are breached. For example, contained use is only contained in so far as there is no accidental, or deliberate, release into the environment. Or, while self-limiting insects or gene drive mosquitoes are intended for use in semi-managed, managed or urban settings, there is always the possibility that mobile organisms can reach a wild setting. What is important is that the potential impacts of such unintentional events are also anticipated and assessed.

Fifth, assessment of potential impacts is an obligation under the CBD,  so it is not a question of whether to assess. And while it is correct that only a few applications devel­oped for direct use in the environment have been authorized to date, with little field data available, this does not mean that the impacts cannot be assessed. It is also relevant that the document points out that many synthetic biology applications use older or other technologies, like transgenesis, to achieve success. Two points follow – experiences with risk assessment for LMOs remain relevant for synthetic biology organisms, and, the novel and sophisticated techniques that are used to produce synthetic biology organisms can also be used to risk assess those organisms.

Sixth, the document rightly points to the need for greater societal and community engagement and participation, including the need to obtain the free, prior and informed consent of indigenous peoples and local communities. However, regrettably, this is not happening in some countries that are deregulating organisms and products of synthetic biology, without democratic participation. As Parties to the CBD, there is obligation to put much more effort in this regard, in order to align with the many decisions and guidelines that the CBD has already adopted on these issues, as well as to guard against real and apparent conflicts of interest.

Seventh, regulation, and not self-regulation, is essential, particularly given the dual-use nature of many applications of synthetic biology. Parties to the CBD and the Cartagena Protocol already have legally binding obligations to regulate LMOs resulting from biotechnology and modern biotechnology, respectively, so we believe that the CBD and its Protocols are currently the best home for the international governance of synthetic biology. This is complemented by other international agreements that have mandates on specific aspects of synthetic biology, and whose governance thereof should align with CBD principles. It is also crucial that the approaches that Parties take, for example, on genome editing, be in line with their obligations under these instruments.

Finally, as this is a living document, there remain opportunities for improvement. We would like to see, for example, future sections dealing with self-spreading GM vaccines, which are for intentional release into the environment and designed to spread quickly, have long exposure periods, and are potentially more stable in the environment. The resulting increased degree of complexity and uncertainties associated with such applications warrant further scrutiny.

Additionally, it is important that there is continuously updated knowledge. For example, with regard to genome editing, research now demonstrates unintended on-target effects that have implications for safety and efficacy. Assumptions about there being no exogenous DNA in SDN-1 and SDN-2 applications have not been borne out by experimental evidence. Similarly, with RNAi sprays, claims that dsRNA is readily degraded or that ODM is transiently introduced and later degraded, are not confirmed by recent literature. Such examples demonstrate a consistent need to update knowledge, so that the applications are robustly assessed for their potential impacts and regulated accordingly.

Thank you very much.