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What has been done on risk assessment

Current Activities on Risk Assessment

In decision CP-9/13, the Conference of Parties serving the meeting of Parties to the Cartagena Protocol on Biosafety (COP-MOP) noted the availability of numerous guidance documents and other resources to support the process of risk assessment, and recognized the gaps and needs identified by Parties. Furthermore, the COP-MOP recognized the divergence in views among Parties on whether or not additional guidance on specific topics of risk assessment is needed.

The COP-MOP also 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.

Also in decision CP-9/13, the COP-MOP:
  1. Decided to establish a process for the identification and prioritization of specific issues regarding risk assessment of living modified organisms (LMOs) 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;
  2. Decided to establish an Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and extended the online forum on risk assessment and risk management in order to assist the AHTEG; and
  3. 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.

The COP-MOP also requested the Executive Secretary to commission studies informing the application of Annex I of the decision to living modified (LM) fish and LMOs containing engineered gene drives. The studies will be presented to the online forum and the AHTEG on Risk Assessment to inform their discussions.

Among other things, the AHTEG is to make recommendations on the need for the development of guidance on risk assessment of LMOs containing engineered gene drives and LM fish and to prepare a report for consideration by the Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA). SBSTTA is to make a recommendation to COP-MOP, which will consider, at its tenth meeting, whether additional guidance materials on risk assessment are needed for (i) LMOs containing engineered gene drives, and (ii) LM fish.

In light of these requests, a tentative calendar of activities outlining a way forward for the implementation of the elements of the COP-MOP decision is available.

History of COP-MOP Decisions on Risk Assessment

In their decision BS-II/9 the Parties considered Risk Assessment and Risk Management. They established an Ad Hoc Technical Expert Group on Risk Assessment (AHTEG) 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 COP-MOP and subject to availability of funds, regional workshops on capacity-building and exchange of experiences on risk assessment risk management of LMOs.

In their decision BS-III/11 the COP-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 COP-MOP also examined further measures for enhancing capacity-building in risk assessment.

In their decision BS-IV/11, the Parties to the Protocol established: (i) an open-ended online forum through the Biosafety Clearing-House (hereinafter “Open-ended Online Forum”); and (ii) an Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management with the objective to develop further guidance on specific aspects of risk assessment and risk management. Furthermore, COP-MOP requested the Executive Secretary to organize training activities on risk assessment and risk management, including hands-on regional or subregional training courses.

At their fifth meeting, the Parties 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, COP-MOP 5 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 COP-MOP 5 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.

In their decision BS-VI/12, the Parties 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. 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 their seventh meeting, the Parties 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, the COP-MOP also decided to extend the 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 Open-Ended 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. The COP-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 their eighth meeting, in decision BS-VIII/12, the COP-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 COP-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 COP-MOP decided to extend the 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 COP-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 COP-MOP.

At their ninth meeting, the COP-MOP mandated further activities related to risk assessment and risk management, as per 9/13 as described above.

Activities of the AHTEG

An outline of the activities of the former AHTEGs can be found at the AHTEG homepage