Niveau juridique : International
Report of the Ad Hoc Technical Expert Group on Synthetic Biology Montreal, Canada, 5-8 December 2017
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»3.1. Recent technological developments in the field of synthetic biology
1.In its deliberations under this agenda item, the AHTEG acknowledged that technological developments within the field of synthetic biology were advancing at an accelerated rate, resulting in an increasing number of organisms that had been engineered using various tools and techniques.
2.In reviewing the recent technological developments of synthetic biology, the AHTEG noted, inter alia, the following:
(a) Some recent synthetic biology techniques expand the range of organisms that can be modified;
(b) Synthesis of whole genomes and chromosomes is now possible and can have significant implications on the way modification of organisms is done;
(c) the development of various gene editing tools enables the simultaneous targeting of multiple sites, or multiplexing, within a genome in one step;
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(f) Some recent developments in synthetic biology have advanced to the point at which organisms might be considered for introduction into the environment at an accelerated rate;
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(h) Combining new biotechnology tools and automation allows the more rapid production of modified organisms;
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17. The recent developments in synthetic biology and the continued pace of development might pose challenges to the ability to understand the possible impacts on biodiversity and human health. There might be a need to consider more thoroughly the potential benefits and potential adverse effects at the ecosystem level, particularly for some developments, such as engineered gene drives.
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19. The potential dual use nature of some advances in synthetic biology might raise biosecurity concerns in relation to the three objectives of the Convention.
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3.2. Evidence of benefits and adverse effects of organisms, components and products of synthetic biology vis-à-vis the three objectives of the Convention
22. Under this agenda item, the AHTEG recalled the conclusion reached at its previous meeting that the organisms, components and products of synthetic biology were expected to have similar types of positive and negative impacts on biological diversity as classical genetic engineering. However, it considered that the potential positive and negative impacts of synthetic biology might be broader and more wide-ranging due to the potential for synthetic biology to produce organisms and biological systems with ranging levels of complexity for use in a range of applications.
23. The AHTEG noted that, beyond the experience gained from LMOs already released into the environment, to date, there was limited direct empirical evidence of the benefits and adverse effects on biodiversity resulting from the organisms, components and products of synthetic biology.
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25. The AHTEG noted that consideration of the potential benefits and adverse effects of organisms produced through synthetic biology could be particularly relevant and urgent for those organisms that had been developed to contain engineered gene drives, in the light of the impacts that such organisms might have on the conservation and sustainable use of biological diversity, as well as the knowledge, innovations and practices of indigenous peoples and local communities, particularly if they were released into the environment. Uncertainties related to the efficacy and safety of engineered gene drive systems, as well as the relative risks that could be posed by the different applications of engineered gene drive systems (for example, for population replacement or suppression) were noted. Furthermore, while there could be potential benefits to the development of such organisms, it was noted that additional research and guidance were needed before any organism containing engineered gene drives could be considered for release into the environment, including into lands and territories of indigenous peoples and local communities. The AHTEG also noted the potential for the unintended transboundary movements and geographic spread of organisms released into the environment. Given the current uncertainties regarding engineered gene drives, a precautionary approach and cooperation with all countries and stakeholders that could be affected, taking into account the need for the free, prior and informed consent of indigenous peoples and local communities, might be warranted in the development and release of organisms containing engineered gene drives, including experimental releases, in order to avoid potential significant and irreversible adverse effects to biodiversity.
26. The discussion under this agenda item also considered the possible impacts of synthetic biology on the traditional knowledge, innovation, and practices of indigenous peoples and local communities, as well as how synthetic biology would impact the relationship of indigenous peoples and local communities with Mother Nature. The development of such technologies should be accompanied by the full and effective participation of indigenous peoples and local communities with a view to creating a vision that would further guide advances and understanding in the field of synthetic biology and to integrating the concerns and needs of indigenous peoples and local communities in decision-making.
3.3. Living organisms developed through synthetic biology that may not be regarded as living modified organisms as per the Cartagena Protocol on Biosafety
27. The AHTEG discussed this item on the basis of the contributions of the online forum and further analysed whether and how organisms developed through synthetic biology fulfilled the criteria of the definition of LMOs as per Article 3 of the Cartagena Protocol.
28. As a result of its deliberations, the AHTEG concluded that most living organisms already developed or currently under research and development through techniques of synthetic biology, including organisms containing engineered gene drives, fell under the definition of LMOs as per the Cartagena Protocol.
29. Techniques involving cell-free systems did not result in the development of living organisms. Likewise, to date, protocells that were capable of replicating genetic material did not exist and, as such, were not living organisms. In the future, however, protocells that were capable of transferring or replicating genetic material might be developed and those might be regarded as LMOs.
30. Furthermore, there were different interpretations as to whether or not organisms modified through epigenetic engineering contained novel combinations of genetic material and, therefore, those organisms might or might not be regarded as LMOs. (…)
3.4. Tools to detect and monitor the organisms, components and products of synthetic biology
32. The AHTEG noted that most tools that were currently in use for the detection, identification and monitoring of LMOs could also be used for organisms developed through synthetic biology, but those tools might need to be updated and adapted.
33. The AHTEG also noted that challenges might arise in the case of organisms that might not have a suitable target marker(s) and when the resulting LMO was indistinguishable from a naturally occurring or conventionally bred counterpart. In such cases, the development of additional detection, identification and monitoring tools might be needed.
34. With regard to detecting and monitoring products of synthetic biology, it was noted that analytical techniques could be used to distinguish between products of synthetic biology and naturally occurring or chemically synthesized counterparts. However, further development in that area might be needed.
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38. It was also suggested that developers of organisms resulting from synthetic biology that were intended for introduction into the environment or for placing on the market could be made responsible for providing validated tools, relevant sequence data and reference materials, in an accessible manner, that would facilitate the detection, identification and monitoring of such organisms and products thereof, as was already the case for LMOs under some frameworks.
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3.5. Risk management measures, safe use and best practices for safe handling of organisms, components and products of synthetic biology
39. The AHTEG took the view that it would be important to consider risk assessment as well as risk management in the discussion on this agenda item.
Risk assessment
40. The AHTEG reiterated that the general principles and methodologies for risk assessment under the Cartagena Protocol and existing national biosafety frameworks, as well as voluntary guidance, could provide a good basis for risk assessment of organisms developed through synthetic biology. These methodologies might need to be periodically updated and adapted.
41. Updates and adaptations might be needed to account for:
(a) The lack of suitable comparators in cases whereby organisms developed through techniques of synthetic biology contain features that are significantly different from existing organisms;
(b) Knowledge gaps in assessing unintended effects that might result from complex changes and novel traits;
(c) Knowledge gaps in assessing interactions of combinatorial and cumulative effects of multiple organisms developed through synthetic biology being released in the same environment;
(d) Lack of experience with the introduction of organisms containing engineered gene drives into natural populations.
42. The AHTEG also noted the existence of voluntary guidance documents that could be taken into account in the risk assessment of organisms developed through synthetic biology. (1)
43. In addition, the AHTEG noted the need to develop and conduct assessments of the potential positive and negative impacts of synthetic biology on the three objectives of the Convention, taking into account the continuing loss of biodiversity, including species extinctions and degradation of ecosystems, the relationship between indigenous peoples and local communities and Mother Nature, and the rights recognized by the United Nations Declaration on the Rights of Indigenous Peoples.
44. The AHTEG further noted that existing risk assessment considerations and methodologies might not be sufficient or adequate to assess and evaluate the risks that might arise from organisms containing engineered gene drives due to limited experience and the complexity of the potential impacts on the environment. The development or further development of guidelines on risk assessment of organisms containing engineered gene drives by the Convention, other international organizations, national governments and professional bodies would be useful in that regard.
45. Some experts noted that a stepwise approach might be appropriate in order to gather information that is needed to fill knowledge gaps and avoid adverse effects or minimise the likelihood of them occurring. However, the step of release into the environment might be irreversible and, therefore, a precautionary approach might be warranted.
46. The AHTEG noted the need to promote and support capacity-building and knowledge-sharing on synthetic biology, risk analysis and related matters in order to meet the needs of developing countries and of indigenous peoples and local communities, taking into account traditional knowledge, innovation, culture, free, prior and informed consent, customary practices and community protocols in the context of articles 8(j) and 10(c) of the Convention and the Akwé: Kon guidelines.
Risk management
47. The AHTEG noted that risk management measures should be imposed to the extent necessary to prevent adverse effects, taking into account uncertainties and lack of knowledge, and in accordance with national legislation and the customary law of indigenous peoples and local communities.
48. Current strategies for risk management and monitoring of LMOs might provide a good basis for managing the risks and monitoring potential impacts of organisms developed through synthetic biology. These strategies might need to be adapted and complemented in order to address specific characteristics of organisms developed through synthetic biology.
49. Cooperation with international organizations and other relevant stakeholders could assist in identifying best practices within other frameworks that were relevant for risk management and monitoring of organisms, components and products of synthetic biology, and that were consistent with the objectives of the Convention.
50. The AHTEG discussed the appropriateness of current containment measures and noted the existence of guidelines for various levels of containment, ranging from laboratory settings to outdoor facilities. The AHTEG also noted that the requirements for the implementation of these containment measures varied among countries.
51. Regarding the containment of organisms containing engineered gene drives, the following points were raised:
(a) Best practices for effective containment of LMOs should be adapted and applied for organisms containing engineered gene drives;
(b) Islands are not ecologically fully contained environments and should not be regarded as fulfilling the conditions in the definition of contained use as per Article 3 of the Cartagena Protocol unless it is so demonstrated;
(c) Internationally agreed standards for effective containment of organisms containing engineered gene drives might be useful in order to avoid accidental releases from laboratory facilities.
52. The AHTEG noted that horizon scanning of synthetic biology under the Convention could also keep track of progress in the adaptation of risk assessment and risk management of organisms developed through synthetic biology.
53. The AHTEG highlighted the need to take into account the socio-economic impacts, perspectives, rights and lands of indigenous peoples and local communities when considering the possible release of organisms developed through synthetic biology into the lands and territories of indigenous peoples and local communities.
(1) Such as the Guidance on Risk Assessment developed by the AHTEG on Risk Assessment and Risk Management and other relevant guidance documents as per decision CP VIII/12. »
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