What has been done on risk assessment
Current activities on risk assessment
At their eleventh meeting, the Conference of the Parties serving the meeting of Parties to the Cartagena Protocol on Biosafety (CP-MOP) welcomed with appreciation the outcomes of the AHTEG and also welcomed the additional voluntary guidance materials to support the case-by-case risk assessment of living modified organisms containing engineered gene drives (CBD/CP/MOP/11/9) in its decision CP-11/7. The CP-MOP invited Parties, other Governments, indigenous peoples and local communities, and relevant organizations and stakeholders that have used the voluntary guidance materials to submit information on their experiences and assessment of the applicability and usefulness of the materials to the Executive Secretary. Parties were further invited to submit detailed 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 annex I to decision CP-9/13. The CP-MOP decided to extend the Open-Ended Online Forum on Risk Assessment to support the analysis of further topics of risk assessment and to establish an Expert Group with terms of reference contained in the annex to the decision.
The Expert Group will analyse the information submitted by Parties and the discussions of the Open-ended Online Forum on Risk Assessment and Risk Management, and on that basis prepare a list of prioritized topics, if any, on which further guidance materials on risk assessment may be needed. The Expert Group will also prepare a report for consideration of the Subsidiary Body on Scientific, Technical and Technological Advice, with a view of enabling the Subsidiary Body to prepare a recommendation for consideration by the CP-MOP.
The twelfth meeting of the CP-MOP will consider additional issues on which guidance materials on risk assessment may be needed, if any, taking into account the needs and priorities identified by Parties and the recommendation of the Subsidiary Body.
History of CP-MOP decisions on risk assessment
In decision BS-II/9, the Conference of the Parties serving as the meeting of the Cartagena Protocol on Biosafety (CP-MOP) first considered risk assessment and risk management as an agenda item. An Ad Hoc Technical Expert Group on Risk Assessment (AHTEG) was established to further consider and evaluate the nature and scope of existing approaches to risk assessment and identify existing gaps, and capacity-building needs. The Executive Secretary was requested to convene, prior to the fourth meeting of the CP-MOP and subject to availability of funds, regional workshops on capacity-building and exchange of experiences on risk assessment risk management of living modified organisms (LMOs).
At its third meeting, in their decision BS-III/11, the CP-MOP further considered a strategy for risk assessment and risk management based on information received from interim national reports under the Protocol, a synthesis of views and compilations of existing guidance materials as well as the report of the AHTEG. The CP-MOP also examined further measures for enhancing capacity-building in risk assessment.
At its fourth meeting, the CP-MOP established: (i) an open-ended online forum through the Biosafety Clearing-House (hereinafter “Open-ended Online Forum on Risk Assessment and Risk Management”); and (ii) an AHTEG on Risk Assessment and Risk Management with the objective to develop further guidance on specific aspects of risk assessment and risk management in decision BS-IV/11. Furthermore, CP-MOP requested the Executive Secretary to organize training activities on risk assessment and risk management, including hands-on regional or subregional training courses.
At its fifth meeting, the CP-MOP welcomed the document "Guidance on Risk Assessment of Living Modified Organisms" (hereinafter “the Guidance”) developed through the joint efforts of the two groups and called for its first version, in their decision BS-V/12, to be further scientifically reviewed and tested to establish its overall utility and applicability to living modified organisms of different taxa introduced into different environments. With regard to capacity-building in risk assessment, the CP-MOP welcomed reports of the two Subregional Workshops on Capacity-building and Exchange of Experiences on Risk Assessment and the training manual on risk assessment. Additionally, the CP-MOP invited governments to submit relevant information that may assist Parties in the identification of LMOs or specific traits that may or are not likely to have adverse effects on biodiversity.
At its sixth meeting, the CP-MOP commended the progress made on the resulting Guidance on Risk Assessment of Living Modified Organisms, the revised Training Manual on Risk Assessment of Living Modified Organisms as well as the initial concept of an e-learning tool in their decision BS-VI/12. They also welcomed reports of the Subregional Workshops on Capacity-building that were held by the Secretariat. Furthermore they decided to extend the Open-ended Online Forum while bringing to a close the current AHTEG. The Parties further decided to establish a new AHTEG on Risk Assessment and Risk Management, that will work following the input provided by the Open-Ended Online Forum, in accordance with the terms of reference and modalities of work in the Annex to the decision.
At its seventh meeting, the CP-MOP welcomed the results of the testing of the Guidance and invited Parties, other Governments and relevant organizations to test or use, as appropriate, the Guidance in actual cases of risk assessment and as a tool for capacity-building activities in risk assessment in their decision BS-VII/12. Further, the CP-MOP also decided to extend the Open-ended Online Forum and AHTEG on Risk Assessment and Risk Management as well as expanding the composition of the AHTEG to add one new member from each region. The expanded AHTEG will work following the input provided by the online forum, in accordance with the terms of reference and modalities of work in the Annex to the decision, to revise and improve the Guidance on Risk Assessment of Living Modified Organisms, taking into account the results of the testing process, established in decision BS-VI/12. Furthermore, the CP-MOP also welcomed the package that aligns the Guidance and Training Manual and invited Parties and other Governments and relevant organizations to test or use, as appropriate, the package as a tool for, inter alia, capacity-building in risk assessment.
At its eighth meeting, in decision BS-VIII/12, the CP-MOP acknowledged the work of the AHTEG on Risk Assessment and Risk Management and the Online forum on Risk Assessment and Risk Management for completing their mandate. The CP-MOP also took note of the voluntary Guidance on Risk Assessment and invited interested Parties, other Governments and relevant organizations to take the guidance into account as a voluntary tool to assist in conducting risk assessment in accordance with the Cartagena Protocol, while also acknowledging other guidance documents and national approaches can also assist in conducting risk assessment in accordance with the Protocol. The CP-MOP decided to extend the Open-Ended Online Forum on Risk Assessment and Risk Management to exchange experiences on risk assessment, provide information and views on, and perceived gaps in existing guidance materials, and proposals to address any gaps identified. Furthermore, the CP-MOP requested the SBSTTA to review the information provided from the online forum and recommend a way forward to address the needs, priorities and gaps identified by Parties for consideration at the ninth meeting of the CP-MOP.
In decision CP-9/13, the nineth meeting of the CP-MOP reaffirmed decision XII/24 of the Conference of Parties urging Parties and inviting other Governments to take a precautionary approach, in accordance with the preamble and Article 14 of the Convention on Biological Diversity, when addressing threats of significant reduction or loss of biodiversity posed by organisms, components and products resulting from synthetic biology, in accordance with domestic legislation and other relevant international obligations. In addition, the COP-MOP also decided to establish a process for the identification and prioritization of specific issues regarding risk assessment of living modified organisms for consideration by the COP-MOP with a view to develop further guidance on risk assessment on the specific issues identified, taking into account Annex I of the decision. Moreover, the CP-MOP requested the commissioning of studies informing the application of Annex I of the decision to living modified (LM) fish and LMOs containing engineered gene drives, established an AHTEG, extended the online forum and invited Parties, other Governments, indigenous peoples and local communities, and relevant organizations to submit to the Executive Secretary information relevant to the work of the online forum and the AHTEG.
At its tenth meeting, CP-MOP welcomed the analysis of the AHTEG on the topics of LMOs containing engineered gene drives and LM fish according to decision CP-9/13, annex I, and endorsed the recommendation of the AHTEG that additional voluntary guidance materials be developed to support case-by-case risk assessment of LMOs containing engineered gene drives in decision CP-10/10. The CP-MOP agreed to develop these additional voluntary guidance materials and decided to establish an AHTEG to work. It also requested the Executive Secretary to commission the preparation of a detailed outline of the additional voluntary guidance materials to support the work of the AHTEG, to convene online discussions of the online forum to review an outline of the additional voluntary guidance materials and to support the work of the AHTEG. Likewise, the same decision invited Parties, other Governments, indigenous peoples and local communities and relevant organizations to submit to the Executive Secretary information relevant to the work of the AHTEG, and invited Parties to also submit information on their needs and priorities for further guidance materials on specific topics of risk assessment of LMOs, including a rationale following the criteria set out in decision CP-9/13, annex I.
