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Reaffirming paragraph 4 of decision XI/11, in which it recognized the development of technologies associated with synthetic life, cells or genomes, and the scientific uncertainties of their potential impact on the conservation and sustainable use of biological diversity, urged Parties and invited other Governments to take a precautionary approach, in accordance with the preamble of the Convention and with Article 14, when addressing threats of significant reduction or loss of biological diversity posed by organisms, components and products resulting from synthetic biology, in accordance with domestic legislation and other relevant international obligations,
Noting decision BS-VII/12 of the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety, recommending a coordinated approach 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,
1.Takes note of the conclusions of the Subsidiary Body on Scientific, Technical and Technological Advice at its eighteenth meeting, as contained in paragraph 1 of recommendation XVIII/7, recognizes that this issue is of relevance to the Conventionand concludes that there is currently insufficient information available to finalize an analysis, using the criteria set out in paragraph 12 of decision IX/29, to decide whether or not this is a new and emerging issue related to conservation and sustainable use of biodiversity;
2.Awaits the completion of a robust analysis using the criteria set out in paragraph 12 of decision IX/29;
3.Urges Parties and invites other Governments to take a precautionary approach, in accordance with paragraph 4 of decision XI/11, and:
(a)To establish, or have in place, 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, consistent with Article 3 of the Convention;
(b)To approve organisms resulting from synthetic biology techniques for field trials only after appropriate risk assessments have been carried out in accordance with national, regional and/or international frameworks, as appropriate;
(c)To carry out scientific assessments concerning organisms, components and products resulting from synthetic biology techniques with regard to potential effects on the conservation and sustainable use of biodiversity, taking into account risks to human health and addressing, as appropriate, and according to national and/or regional legislation, other issues such as food security and socioeconomic considerations with, where appropriate, the full participation of indigenous and local communities;
(d)To encourage the provision of funding for research into synthetic biology risk assessment methodologies and into the positive and negative impacts of synthetic biology on the conservation and sustainable use of biodiversity, and to promote interdisciplinary research that includes related socioeconomic considerations;
(e)To cooperate in the development and/or strengthening of human resources and institutional capacities, including on methodologies for risk assessments in synthetic biology and its potential impacts on biodiversity, in developing countries, in particular the least developed countries and small island developing States, and countries with economies in transition, including through existing global, regional and national institutions and organizations and, as appropriate, by facilitating civil society involvement. The needs of developing country Parties, in particular the least developed countries and small island developing States among them, and Parties with economies in transition, for financial resources; access to and transfer of technology consistent with Article 16 of the Convention; establishing or strengthening regulatory frameworks; and the management of risks related to the release of organisms, components and products resulting from synthetic biology techniques, should be taken fully into account in this regard;
4.Decides, subject to the availability of resources, to establish an Ad Hoc Technical Expert Group, with terms of reference contained in the annex to the present decision, to be convened after the Executive Secretary has completed the requests in paragraph 7 below;
5.Invites Parties, other Governments, relevant organizations and stakeholders to submit information to the Executive Secretary relevant to the work of the Ad Hoc Technical Expert Group established by the present decision, as well as on measures undertaken in accordance with paragraph 3 above, including the identification of needs for guidance;
6.Invites Parties, other Governments, relevant international organizations, indigenous and local communities and relevant stakeholders to continue to provide further information to the Executive Secretary in response to decision XI/11, paragraph 3 (a);
(a)To make available the information reported in accordance with paragraphs 5 and 6 above, through the clearing-house mechanism of the Convention and other means;
(b)To convene a moderated open-ended online forum1 to support the work of the Ad Hoc Technical Expert Group established in paragraph 4 above in meeting its terms of reference;
(c)To prepare an updated report on the work specified in paragraphs 3 (a), 3 (b) and 3 (c) of decision XI/11, taking into account information submitted in paragraphs 5 and 6 above and a synthesis of the outcomes of the process mentioned in paragraph 7 (b) and to submit these for consideration by the Ad Hoc Technical Expert Group;
(d)To submit for consideration by a meeting of the Subsidiary Body on Scientific, Technical and Technological Advice prior to the thirteenth meeting of the Conference of the Parties, the peer‑reviewed reports of the outcomes of the process mentioned in paragraphs 7 (b) and 7 (c) above;
8.Invites relevant organizations, including relevant United Nations organizations and bodies, to consider the possible implications of synthetic biology as it relates to their mandates.