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Past Activities 2017-2018

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Discussion Summary [#8800]

Dear Forum participants,
I would like to thank you all for your contributions to the final topic of discussion of the open-ended forum on synthetic biology which focused on “Gathering information on risk management measures, safe use and best practices for safe handling of organisms, components and products of synthetic biology”. There were 30 comments made by participants from 7 Parties, 1 non-Party and 13 organizations.

I would like to, once again, acknowledge that there were several participants that had expressed their concern in also addressing risk assessment during this discussion, however, as outlined in my mid-point intervention, the AHTEG will be discussing risk assessment of synthetic biology applications, taking into account the submissions made by Parties through paragraph 10 of the decision. I will therefore focus this summary on the points raised that relate to risk management and the guiding questions.

In general, participants emphasized the importance of having robust risk management practices in place in order to ensure that the three objectives of the convention are met and that provisions are in place for the safe handling of organisms, protecting safety, health, and the environment. At the same time, other participants highlighted the need for dealing with synthetic biology in a way that allows for innovation and societal benefit from its potential contributions to global biodiversity, without imposing lengthy and costly regulatory processes.

There was general agreement amongst participants that current risk management measures and best practices, such as confinement strategies, restrictions in use, monitoring and reporting requirements as well as contingency plans, that are in use for “traditional” LMOs are also sufficient in the context of living organisms developed through current and near future applications of synthetic biology. That being said, some participants also highlighted that while such measures may be adequate for the time being, more research and evaluation might be needed as advances in the field of synthetic biology continue. Moreover, some participants noted that recommendations and decisions regarding the need for risk management measures are made on a case-by-case basis depending on the organism and type of risk being managed and, for this reason, general discussions on risk management strategies for synthetic biology applications are of limited value.

With respect to the components (e.g. a DNA molecule) and products (e.g. a chemical substance produced by an organism) of synthetic biology, in discussing the extent to which current risk management measures and best practices are sufficient, several participants pointed to the availability of national and international legislation that governs the handling and risk management of chemical substances regardless of whether they were produced using chemical synthesis or synthetic biology. Such legislations include those that focus on industrial chemicals, plant protection products, food additives, medicinal products and biological weaponry, amongst others. On the other hand, some participants highlighted that such provisions would only cover those products that are captured by specific product related legislation and may focus more on the trade related matters as opposed to their impact on the three objectives of the Convention therefore some risk management measures relating to components and products of synthetic biology may be overlooked.

With regards to participants foreseeing a need for adapting safety measures in the future as developments in the field of synthetic biology are made, participants indicated that the approaches that are presently in place are inherently adaptable and flexible enough to accommodate new knowledge due to the case-by-case nature of risk management practices. However, concerns were raised regarding the capacity of regulatory agencies to stay abreast of the increased influx of cases involving new organisms and their ability to efficiently provide the quantity and quality of new risk management measures that will be required.

Concrete examples of existing applications of synthetic biology to which risk management measures may not be sufficient to ensure the safe handling and use of living organisms developed through synthetic biology were not provided. However, several participants raised concern about organisms produced through synthetic biology that are designed to interact with and modify existing ecosystems, specifically, those containing gene drives. Some participants indicated that this is an area where additional guidance in the context of the objectives of the Convention and its Protocols is needed.

Some participants were of the view that specific new areas of research in order to ensure the safe use of current and near future applications of synthetic biology are not needed. These participants also highlighted that, due to the varied nature of organisms produced through synthetic biology techniques, ranging from microorganisms, to plants to insects, it may be more useful to consider the risk management of such organisms in a more specific context based on their intended use rather than under the umbrella of synthetic biology, which is too broad a categorization and may not serve to fill the necessary knowledge gaps relating to their safety. Other participants provided specific examples of areas where more research may be needed, including the interface of synthetic biology and ecology specifically focusing on gene transfer, direct competition, and habitat modification resulting from the interaction between organisms produced through synthetic biology and other species.

Finally, several participants submitted references relating to guidelines and guidance on risk management measures that may be applicable to organisms, components and products of synthetic biology. These are compiled in the document attached to this post and can also be accessed here http://bch.cbd.int/cms/ui/forums/attachment.aspx?id=1417.

I would wish to appreciate all of you for the valuable contributions which will enrich the work of the coming AHTEG in December and the subsequent SBSTTA.

Thanks so much for your in-depth analysis of the issue, comments and proposals.

Benson Mburu Kinyagia
(edited on 2017-10-20 13:22 UTC by Dina Abdelhakim)
posted on 2017-10-20 13:21 UTC by Dina Abdelhakim, SCBD