Risk assessment and risk management (Articles 15 and 16)
The Conference of the Parties serving as the meeting to the Parties to the Cartagena Protocol on Biosafety,Recalling decision CP-9/13, paragraph 7, in which it decided to consider, at its tenth meeting, whether additional guidance materials on risk assessment are needed for (a) living modified organisms containing engineered gene drives, and (b) living modified fish,Recalling also decision BS-VII/12, paragraph 17, in which it recommended to the Conference of the Parties to the Convention of Biological Diversity a coordinated approach with the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety on the issue of synthetic biology, taking into account the possibility that the provisions of the Protocol might also apply to living organisms resulting from synthetic biology,Recalling further the importance of the precautionary approach, in accordance with the Cartagena Protocol on Biosafety,Noting the existing voluntary guidance on the assessment of socioeconomic considerations in the context of Article 26 of the Cartagena Protocol on Biosafety,1.Welcomes the outcomes of the discussions of the Ad Hoc Technical Expert Group on Risk Assessment;11CBD/CP/RA/AHTEG/2020/1/5.2.Takes note of the clarifications made by the Ad Hoc Technical Expert Group on annex I to decision CP-9/13 regarding the process for identification and prioritization of specific issues of risk assessment of living modified organisms that may warrant consideration;22See CBD/CP/RA/AHTEG/2020/1/5, annex I, sect. III.3.Welcomes the analysis done by the Ad Hoc Technical Expert Group on the topics of (a) living modified organisms containing engineered gene drives and (b) living modified fish pursuant to decision CP-9/13, annex I;4.Notes the range of perspectives on the need for the development of guidance on risk assessment of living modified fish, decides not to proceed, at this stage, with the development of additional voluntary guidance materials on risk assessment regarding living modified fish, and encourages Parties and invites other Governments and relevant organizations to promote international cooperation, information sharing and capacity-building on risk assessment of living modified fish, and to make use of existing guidance materials, with a view to considering further guidance on living modified fish at its eleventh meeting, subject to the provisions of annex I to decision CP-9/13;5.Endorses the recommendation of the Ad Hoc Technical Expert Group that additional voluntary guidance materials to support case-by-case risk assessment of living modified organisms containing engineered gene drives should be developed, and agrees to develop such additional voluntary guidance materials as per the annex below;6.Decides to establish an ad hoc technical expert group on risk assessment that will work according to the terms of reference annexed hereto;7.Invites Parties, other Governments, indigenous peoples and local communities and relevant organizations to submit to the Executive Secretary information relevant to the work of the Ad Hoc Technical Expert Group on Risk Assessment established in paragraph 6 above;8.Invites Parties to also submit information on their needs and priorities for further guidance materials on specific topics of risk assessment of living modified organisms, including a rationale following the criteria set out in decision CP-9/13, annex I;9.Calls upon Parties, other Governments and relevant organizations to continue to disseminate information and share experiences, especially through the Biosafety Clearing-House, that are useful for risk assessments of living modified organisms, including living modified fish and organisms containing engineered gene drives;10.Requests the Executive Secretary:(a)To commission, subject to the availability of resources and applying decision 14/33 on the procedure for avoiding or managing conflicts of interest in expert groups, the preparation of detailed outline of additional guidance materials on risk assessment of living modified organisms containing engineered gene drives to be reviewed by the online forum as a base for the work of the Ad Hoc Technical Expert Group;(b)To convene online discussions of the Online Forum on Risk Assessment and Risk Management to review an outline of the additional voluntary guidance materials and to support the work of the Ad Hoc Technical Expert Group;(c)To collect and synthesize relevant information to facilitate the work of the Online Forum and the Ad Hoc Technical Expert Group;(d)To synthesize the views referred to in paragraphs 7 and 8 above and the discussions of the Online Forum and make them available to the Ad Hoc Technical Expert Group;(e)To convene, subject to the availability of resources, two meetings of the Ad Hoc Technical Expert Group on Risk Assessment, with at least one of the meetings as a face-to-face meeting;33Depending on restrictions due to the pandemic situation.(f)To facilitate the process of identification and prioritization of specific issues of risk assessment of living modified organisms that may warrant consideration, as established in paragraph 6 of decision CP-9/13, by making information submitted by Parties on issues identified in accordance with annex I to the same decision, as well as information useful for the risk assessment of those topics, available through a dedicated web page within the Biosafety Clearing-House;(g)To ensure the full and effective participation of indigenous peoples and local communities in the discussions and in the work on risk assessment under the Cartagena Protocol;(h)To explore ways to facilitate and support capacity-building and knowledge-sharing and technology transfer regarding risk assessment and risk management of living modified organisms;(i)To provide dedicated web pages in the Biosafety Clearing-House to facilitate easy access and raise awareness of available information that is relevant for risk assessment of living modified organisms, including living modified fish and organisms containing engineered gene drives;11.Requests the Subsidiary Body on Scientific, Technical and Technological Advice to consider the outcomes of the Ad Hoc Technical Expert Group on Risk Assessment at its twenty-sixth meeting and to make a recommendation for consideration by the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol at its eleventh meeting;12.Decides to consider, at its eleventh meeting, additional issues on which guidance materials on risk assessment may be needed, further to the process for the identification and prioritization of specific issues of risk assessment of living modified organisms established in decision CP-9/13, taking into account priorities identified by Parties pursuant to paragraph 8 above and the report of the Ad Hoc Technical Expert Group as per paragraph 1 (e) of its terms of reference.Annex
Terms of reference for the Ad Hoc Technical Expert Group on Risk Assessment
1.The Ad Hoc Technical Expert Group (Group) on Risk Assessment shall:(a)Be composed of experts selected in accordance with section H of the consolidated modus operandi of the Subsidiary Body on Scientific, Technical and Technological Advice, ensuring specific scientific and technical expertise on organisms containing engineered gene drives and their potential effects on biodiversity as well as on issues relevant to the mandate of the Group, and including experts from relevant international organizations,4 as well as from indigenous peoples and local communities, and applying decision 14/33 on the procedure for avoiding or managing conflicts of interest in expert groups;4Such as the World Trade Organization, the Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services and the Food and Agriculture Organization of the United Nations.(b)Meet twice, subject to the availability of funds and prior to the eleventh meeting of the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety, with at least one of the meetings being face-to-face, and perform necessary tasks between its two meetings supported by online means of communication and engagement;(c)Develop additional voluntary guidance materials for conducting case-by-case risk assessments of living modified organisms containing engineered gene drives in accordance with Annex III to the Protocol. A specific focus of this material should be engineered gene drive mosquitos taking into account the current experience with the organism, the type of gene drive and specific issues of risk assessment, identified in annex I to decision CP-9/13, including existing reports,5 general considerations of living modified organisms containing engineered gene drives, and existing national and regional risk assessment experiences;5Inter alia the Perseus report commissioned by the Secretariat of the Convention on Biological Diversity.(d)Analyse the information submitted by Parties as per paragraph 8 of decision CP-10/10, and, on the basis of this, prepare a list of prioritized topics on which further guidance materials on risk assessment may be needed according to criteria in decision CP-9/13, annex I;(e)Prepare a report, including draft additional voluntary guidance materials on living modified organisms containing engineered gene drives and a list of prioritized topics as per paragraph (d) above, on which further guidance materials on risk assessment may be needed, for consideration by the Subsidiary Body on Scientific, Technical and Technological Advice.2.In undertaking its work, the Group shall consider the synthesis of views from the submissions and discussions in the online forum prepared by the Executive Secretary, existing resources, including those identified in the stocktaking exercise of the “study on risk assessment: application of annex I to decision CP-9/13 to living modified organisms containing engineered gene drives”,6 guidance materials already available, relevant decisions on risk assessment and risk management taken under the Cartagena Protocol on Biosafety and any other relevant information collected by the Executive Secretary further to paragraph 10(c) of decision CP-10/10.6CBD/CP/RA/AHTEG/2020/1/4.