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MOP 5 Decision BS-V/12

BS-V/12.Risk assessment and risk management (Articles 15 and 16)

The Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety,
Recalling its decision BS-IV/11 on risk assessment and risk management,

I.Further guidance on specific aspects of risk assessment

1.Commends the use of innovative methods under the open-ended online forum on risk assessment and risk management as an efficient means to maximize the use of limited financial resources;
2.Takes note of the conclusions and recommendations of the open-ended online forum and the Ad Hoc Technical Expert Group on Risk Assessment and Risk Management and welcomes the resulting “Guidance on Risk Assessment of Living Modified Organisms” (hereinafter referred to as “the Guidance”);
3.Notes that the Guidance is a document in evolution and that its objective is to provide a reference that may assist Parties and other Governments in implementing the provisions of the Protocol with regards to risk assessment, in particular its Annex III and, as such, this Guidance is not prescriptive and does not impose any obligations upon the Parties;
4.Decides to extend the current open-ended online forum and the Ad Hoc Technical Expert Group on Risk Assessment and Risk Management in accordance with the terms of reference annexed hereto;
5.Urges Parties and invites other Governments and relevant organizations to nominate further experts with experience relevant to risk assessment to the open-ended online forum and to actively participate in the online discussions;
6.Further notes that the first version of the Guidance requires further scientific reviewing and testing to establish its overall utility and applicability to living modified organisms of different taxa introduced into different environments, and requests the Executive Secretary to, prior to the first meeting of the Ad Hoc Technical Expert Group on Risk Assessment and Risk Management, (i) translate the first version of the Guidance into all United Nations languages with a view to enabling a large number of experts to take part in the reviewing process; (ii) coordinate with Parties and other Governments, through their technical and scientific experts, and relevant organizations, a review process of the first version of the Guidance; (iii) make the comments of the review process available through the Biosafety-Clearing House;
7.Requests the Executive Secretary to convene, prior to the sixth meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol, (i) ad hoc discussion groups and real-time online conferences under the open-ended online forum, and (ii) two meetings of the Ad Hoc Technical Expert Group, and to compile the views and recommendations submitted by participants in the online forum for consideration by the Parties;
8. Further requests the Executive Secretary to: (i) update the common format for submission of records to the Biosafety Information Resources Centre in order to link its records on risk assessment to specific sections of the Guidance; and (ii) explore possible ways to link background materials available in the “Scientific Bibliographic Database on Biosafety” to specific sections of the Guidance;

II.Capacity-building in risk assessment

Welcoming the development of a training manual on risk assessment of living modified organisms,
Welcoming also the reports of the Pacific Subregional Workshop on Capacity-building and Exchange of Experiences on Risk Assessment (UNEP/CBD/BS/COP-MOP/5/INF/16) held in Nadi, Fiji and of the Asian Subregional Training Course on Risk Assessment of Living Modified Organisms (UNEP/CBD/BS/COP-MOP/5/INF/17) held in Siem Reap, Cambodia and taking note of their recommendations,
9.Requests the Executive Secretary to:
(a)Submit the training manual to experts and other reviewers from Parties and other Governments for an assessment of its effectiveness;
(b)Convene, at the earliest convenient date, further regional or subregional training courses to enable countries to gain hands-on experience in the preparation and evaluation of risk assessment reports in accordance with the relevant articles and Annex III of the Protocol, and to further test the first version of the Guidance and make the results of the testing available through the Biosafety-Clearing House;
(c)Improve the training manual “Risk Assessment of Living Modified Organisms” in cooperation with relevant United Nations bodies, other relevant organizations and expert reviewers by revising it on the basis of the recommendations provided during the regional and subregional capacity-building activities and feedback from Parties, in such a way that any further improvements of the training manual, on the one hand, and of the Guidance through the process outlined in paragraph 6 above, on the other hand, is made in a coherent and complementary manner;
(d)Develop an interactive learning tool based on the training manual, and make it available through the Biosafety Clearing-House in all United Nations languages with the view to developing a more cost-effective way for delivering training on risk assessment;

III.Identifying living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health

Welcoming the views submitted by Parties, other Government and relevant organizations regarding the identification of living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health and acknowledging the challenges in harmonizing the divergent views,
Welcoming also the recommendations by the Ad Hoc Technical Expert Group on Risk Assessment and Risk Management regarding possible modalities for cooperation in identifying living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, in particular the implementation of a step-wise approach for this purpose that starts with the exchange of information,
10.Urges Parties and invites other Governments to submit to the Biosafety Clearing-House decisions and risk assessments where potential adverse effects have been identified, as well as any other relevant information that may assist Parties in the identification of living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, including information, if possible, when a decision is not taken due to the potential of a living modified organism to cause adverse effects when introduced into specific environments;
11.Requests the Executive Secretary to compile the information for consideration by the Parties at their sixth meeting;

IV.Identifying living modified organisms that are not likely to have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health

Recalling the provisions of the medium-term programme of work, decision BS-I/12 paragraph 7 (a) (i), to consider a modality that might enable the identification of living modified organisms that are not likely to have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, with a view to arriving at a decision in accordance with paragraph 4 of Article 7,
12.Requests Parties and invites other Governments and relevant organizations to submit to the Executive Secretary (i) information on risk assessments, carried out on a case-by-case basis with regards to the receiving environment of the living modified organism, that might assist Parties in the identification of living modified organisms that are not likely to have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and (ii) the criteria that were considered for the identification of such living modified organisms;
13.Requests the Executive Secretary to compile the information received and prepare a synthesis report for consideration by the Parties at their sixth meeting.

Annex

TERMS OF REFERENCE FOR THE OPEN-ENDED ONLINE FORUM AND AD HOC TECHNICAL EXPERT GROUP ON RISK ASSESSMENT AND RISK MANAGEMENT

Methodology

1.The open-ended online forum and the Ad Hoc Technical Expert Group on Risk Assessment and Risk Management shall work primarily online to (i) revise and test the first version of the Guidance on the basis of the results of the scientific review process, the testing associated with capacity-building activities and any testing initiated by the Ad Hoc Technical Expert Group and organized by the Executive Secretary, and (ii) assess the overall applicability and utility of the Guidance to living modified organisms across different taxa and receiving environments, with the view to achieving the expected outcomes outlined below;
2.The Ad Hoc Technical Expert Group on Risk Assessment and Risk Management shall meet twice face-to-face prior to the sixth meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol;

Expected outcomes

3.The open-ended online forum and the Ad Hoc Technical Expert Group on Risk Assessment and Risk Management shall work together with the view to developing and achieving the following:
(a)A revised version of the “Guidance on Risk Assessment of Living Modified Organisms”;
(b)A mechanism, including criteria, for future updates of the lists of background materials;
(c)Further guidance on new specific topics of risk assessment, selected on the basis of the priorities and needs by the Parties and taking into account the topics identified in the previous intersessional period;

Reporting

4.The open-ended online forum and the Ad Hoc Technical Expert Group on Risk Assessment and Risk Management shall submit final reports detailing their activities, outcomes and recommendations for consideration by the sixth meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol.

  • United Nations
  • United Nations Environment Programme