Decision COP XIII/17

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UNEP/CBD/COP/DEC/13/17 filtered
Synthetic biology
The Conference of the Parties
informational

paragraph 1

1.Reaffirms decision XII/24, in which it urged Parties and invited other Governments to take a precautionary approach, in accordance with decision XI/11, paragraph 4;
informational

paragraph 2

2.Reiterates paragraph 3 of decision XII/24 and notes that it can also apply to some living modified organisms containing gene drives;
informational

paragraph 3

3.Commends the work of the online forum and the Ad Hoc Technical Expert Group on Synthetic Biology, and welcomes the conclusions and recommendations of the report of the Group as a basis for further discussion;
informational

paragraph 4

4.Acknowledges that the outcome of the work of the Ad Hoc Technical Expert Group on Synthetic Biology on the operational definition is “synthetic biology is a further development and new dimension of modern biotechnology that combines science, technology and engineering to facilitate and accelerate the understanding, design, redesign, manufacture and/or modification of genetic materials, living organisms and biological systems”, and considers it useful as a starting point for the purpose of facilitating scientific and technical deliberations under the Convention and its Protocols;
informational

paragraph 5

5.Takes note of the conclusion of the Ad Hoc Technical Expert Group on Synthetic Biology that living organisms developed through current applications of synthetic biology, or that are currently in the early stages of research and development, are similar to living modified organisms as defined in the Cartagena Protocol;
informational

paragraph 6

6.Notes that 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 early 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;
informational

paragraph 7

7.Also notes that it is not clear, given the current state of knowledge, whether or not some organisms of synthetic biology, which are currently in the early stages of research and development, would fall under the definition of living modified organisms under the Cartagena Protocol, and further notes that there are cases in which there may be no consensus on whether the result of a synthetic biology application is “living” or not;
operational active parties

paragraph 8

8.Invites Parties, in accordance with their applicable domestic legislation or national circumstances, to take into account, as appropriate, socio-economic, cultural and ethical considerations when identifying the potential benefits and potential adverse effects of organisms, components and products resulting from synthetic biology techniques in the context of the three objectives of the Convention;
operational active other governments parties organizations

paragraph 9

9.Encourages Parties and invites other Governments and relevant organizations, in the context of the three objectives of the Convention and taking into account, if appropriate and in accordance with domestic legislation or national circumstances, socio-economic, cultural and ethical considerations:

paragraph 9 item (a)

(a)To conduct research on the benefits and adverse effects of organisms, components and products of synthetic biology on biodiversity, with a view to filling knowledge gaps and identifying how those effects relate to the objectives of the Convention and its Protocols;

paragraph 9 item (b)

(b)To promote and enable public and multi-stakeholder dialogues and awareness-raising activities on the potential benefits and potential adverse effects of organisms, components and products of synthetic biology on biodiversity, involving all relevant stakeholders and with the full and effective engagement of indigenous peoples and local communities;

paragraph 9 item (c)

(c)To cooperate in the development of guidance and capacity-building activities with a view to assessing the potential benefits and potential adverse effects of organisms, components and products of synthetic biology and, if necessary, updating and adapting current methodologies for risk assessment of living modified organisms to organisms resulting from synthetic biology, as appropriate;
operational implemented parties other governments organizations IPLC

paragraph 10

10.Invites Parties, other Governments, relevant organizations and indigenous peoples and local communities to submit to the Executive Secretary information and supporting documentation on:

paragraph 10 item (a)

(a)Research, cooperation and activities noted in paragraph 9 above;

paragraph 10 item (b)

(b)Evidence of benefits and adverse effects of synthetic biology vis-à-vis the three objectives of the Convention;

paragraph 10 item (c)

(c)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;

paragraph 10 item (d)

(d)Examples of risk management and other measures that have been put in place to avoid or minimize the potential adverse effects of organisms, components and products of synthetic biology, including experiences of safe use and best practices for the safe handling of organisms developed through synthetic biology;

paragraph 10 item (e)

(e)Regulations, policies and guidelines in place or under development which are directly relevant to synthetic biology;

paragraph 10 item (f)

(f)Knowledge, experience and perspectives of indigenous peoples and local communities in the context of living in harmony with nature for comparison and better understanding of the potential benefits and adverse effects of synthetic biology;
operational implemented

paragraph 11

11.Decides to extend the mandate of the current Ad Hoc Technical Expert Group on Synthetic Biology in accordance with the terms of reference annexed hereto and also to contribute to the completion of the assessment as requested in paragraph 2 of decision XII/24;
operational implemented parties other governments IPLC organizations

paragraph 12

12.Also decides to extend the open-ended online forum to support the work of the Ad Hoc Technical Expert Group on Synthetic Biology, and invites Parties, other Governments, indigenous peoples and local communities and relevant organizations to continue nominating experts to take part in the open-ended online forum;
operational implemented SBSTTA

paragraph 13

13.Requests the Subsidiary Body on Scientific, Technical and Technological Advice to review the recommendations of the Ad Hoc Technical Expert Group on Synthetic Biology and make further recommendation to the Conference of the Parties, including on the analysis using the criteria set out in paragraph 12 of decision IX/29;
operational active es

paragraph 14

14.Requests the Executive Secretary, subject to the availability of resources:
operational implemented es

paragraph 14 item (a)

(a)To continue to facilitate moderated discussions under the open-ended online forum on synthetic biology through the Biosafety Clearing-House, and to continue to invite Parties, other Governments, indigenous peoples and local communities and relevant organizations to nominate experts to take part in the forum;
operational implemented es

paragraph 14 item (b)

(b)To make the information received through paragraph 10 above available online;
operational implemented es

paragraph 14 item (c)

(c)To compile and synthesize the results of the work referred to in the paragraphs above and make them available for further discussion through the online forum and the Ad Hoc Technical Expert Group;
operational implemented es

paragraph 14 item (d)

(d)To convene moderated online discussions under the open-ended online forum and, subject to the availability of funds, a face-to-face meeting of the Ad Hoc Technical Expert Group on Synthetic Biology with the terms of reference annexed to the present decision, and submit the report of the Ad Hoc Technical Expert Group to peer review by Parties for consideration by the Subsidiary Body on Scientific, Technical and Technological Advice at a meeting held prior to the fourteenth meeting of the Conference of the Parties;
operational active es

paragraph 14 item (e)

(e)To cooperate and establish synergies with other United Nations and international organizations whose mandates are relevant to synthetic biology;
operational active es

paragraph 14 item (f)

(f)To promote the full and effective engagement of indigenous peoples and local communities in future activities relating to synthetic biology under the Convention;
operational active es

paragraph 14 item (g)

(g)To facilitate, in collaboration with relevant research institutions and organizations, capacity-building and support to developing countries, in particular the least developed countries, small island developing States and countries with economies in transition, on undertaking the activities outlined in paragraph 9 above;
operational active

paragraph 15

15.Welcomes the recommendation of the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety, in its decision BS-VII/12, on a coordinated approach on the issue of synthetic biology, taking into account that the provisions of the Protocol may also apply to living organisms resulting from synthetic biology, and invites the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety to take into account in its future deliberations relevant information resulting from the processes under the Convention.
Body
Conference of the Parties (COP)

Meeting
COP-13
Thirteenth meeting of the Conference of the Parties to the Convention on Biological Diversity
4 - 17 December, 2016
Cancun, Mexico

Elements of decision
31 7 informational 15 operational
15 8 implemented 0 superseded 0 elapsed 7 active

Actors
23 4 parties   3 other-governments   3 organizations   2 IPLC   2   1 SBSTTA   8 executive-secretary  

AICHI targets
0

Subjects
4 Cartagena Protocol on Biosafety Biosafety and Biotechnology Indigenous peoples and local communities Capacity-building

Document
Related decisions
XII/24 para 1
New and emerging issues: 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 Convention and 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;
XII/24 para 3
New and emerging issues: synthetic biology
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;