BS-IV/11. Risk assessment and risk management

The Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety,

Recalling its decision BS-III/11, on risk assessment and risk management,

I. Further guidance on specific aspects of risk assessment and risk management

Recalling paragraph 9 of decision BS-III/11, in which Parties agreed to consider, at the fourth meeting of the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety, the need for further guidance on specific aspects of risk assessment and risk management, and the appropriate modalities for development of any such guidance such as a further meeting of the Ad Hoc Technical Expert Group on Risk Assessment and Risk Management,

1. Takes note of the report of the Norway-Canada Workshop on Risk Assessment for Emerging Applications of Living Modified Organisms, and expresses its gratitude to the Governments of Norway and Canada for organizing this workshop;

2. Takes note of the conclusions and recommendations in the reports of the regional and subregional workshops on capacity-building and exchange of experiences on risk assessment and risk management of living modified organisms regarding the need to develop additional guidance on specific aspects of risk assessment;

3. Decides to establish through the Biosafety Clearing-House an open-ended online forum on specific aspects on risk assessment as referenced to in the annex;

4. Decides to establish an Ad Hoc Technical Expert Group on Risk Assessment and Risk Management according to the modality of work and the terms of reference annexed hereto;

5. Invites Parties, other Governments and relevant organizations to submit to the Executive Secretary, prior to the first meeting of the Ad Hoc Technical Expert Group, information relevant to the work of the Group, particularly on existing guidance documents on risk assessment;

6. Requests the Executive Secretary to:

(a) Convene ad hoc discussion groups and at least one real-time online conference per region prior to each of the meetings of the Ad Hoc Technical Expert Group, with the view to identifying major issues related to specific aspects of risk assessment and risk management as referenced to in the annex;

(b) Convene, prior to the fifth meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol, and subject to the necessary financial resources being made available, two meetings of the Ad Hoc Technical Expert Group on Risk Assessment and Risk Management;

7. Urges Parties, other Governments and relevant organizations to make funds available to the Executive Secretary for the organization of the second meeting of the Ad Hoc Technical Expert Group, prior to the fifth meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol;

II. Collaboration in identifying living modified organisms that may have an adverse effect 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 4 (b) (iii), on 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, and taking appropriate measures regarding the treatment of such living modified organisms or specific traits,

8. Requests Parties and invites other Governments and relevant organizations to submit to the Executive Secretary, not later than three months prior to the first meeting of the Ad Hoc Technical Expert Group, scientifically sound information available at that time, on 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;

9. Requests the Executive Secretary to compile the information received and to prepare a synthesis report for consideration by the Ad Hoc Technical Expert Group and the Parties;

III. Capacity-building relevant to risk assessment and risk management

Recalling that risk assessment and other scientific and technical expertise are indicated as key elements requiring concrete action in the updated Action Plan for Building Capacities for the Effective Implementation of the Biosafety Protocol,

10. Welcomes the reports of the regional and subregional workshops on capacity-building and exchange of experiences on risk assessment and risk management of living modified organisms that were held in Barbados, Ethiopia, Malaysia and the Republic of Moldova;

11. Expresses its gratitude to the Governments of Germany, Netherlands, Norway, Spain and Switzerland for their financial contributions and the hosting Governments and the African Union for their organizational support;

12. Requests the Executive Secretary to convene, in cooperation with relevant regional organizations, at the earliest convenient date and subject to the availability of financial resources, a sub-regional workshop on capacity-building and exchange of experiences on risk assessment and risk management of living modified organisms in the Pacific subregion;

13. Requests the Executive Secretary, subject to availability of funds, to coordinate and facilitate, along with other relevant United Nations bodies and other international organizations, the development of training on risk assessment and risk management in relation to living modified organisms, and to convene prior to the fifth meeting of the Conference of the Parties serving as the meeting of the Parties, regional or subregional training courses to enable countries to gain hands-on experience in preparing and evaluating risk assessment reports in accordance to the articles and Annex III of the Protocol.

14. These courses could, inter alia, cover:

(a) How to establish interdisciplinary teamwork in the context of risk assessment;

(b) Developing skills in using and interpreting existing information, as well as identifying and addressing information gaps; and

(c) How to establish baseline information to be used in risk assessment;

15. Calls upon Parties, other Governments and relevant donor organizations to make funds available to the Secretariat to support the training activities referred to in the above paragraphs.

Annex

TERMS OF REFERENCE FOR THE AD HOC TECHNICAL EXPERT GROUP ON RISK ASSESSMENT AND RISK MANAGEMENT

1. The Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management shall:

(a) Include experts selected on the basis of their expertise on the issues relevant for the mandate of the Group, based on a standardized common format for submission of CVs from experts nominated by Parties, respecting geographical representation, in accordance with the consolidated modus operandi of the SBSTTA of the Convention on Biological Diversity (decision VIII/10 of the Conference of the Parties, annex III);

(b) Include observers in accordance with the rules of procedure for meetings of the Conference of the Parties serving as the meeting of the Parties to the Protocol;

(c) Meet twice, pending availability of funds, with an interval of not less than ten months between meetings and prior to the fifth meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol, and perform necessary tasks between the two meetings to achieve the proposed outcomes outlined herein;

(d) During the first meeting, the Group shall:

(i) Develop a "roadmap", such as a flowchart, on the necessary steps to conduct a risk assessment in accordance with Annex III to the Protocol and, for each of these steps, provide examples of relevant guidance documents;

(ii) Taking into consideration the identified need for further guidance on specific aspects of risk assessment, including particular types of (i) living modified organisms (for example, fish, invertebrates, trees, pharmaplants and algae); (ii) introduced traits; and (iii) receiving environments, as well as monitoring of the long-term effects of living modified organisms released in the environment, prioritize the need for further guidance on specific aspects of risk assessment and define which such aspects should be addressed first, taking also into account the need for and relevance of such guidance, and availability of scientific information;

(iii) Define an action plan to produce, prior to the second meeting of the Group, modalities for development of the guidance documents on the specific aspects that were identified as priorities and for testing of the roadmap. This action plan should include the details of a process for monitoring and reviewing the progress in each of the specific aspects;

(iv) Prepare an progress report containing a detailed summary of the terms and procedures for reviewing the modalities for the development of guidance documents to be followed prior to the second meeting of the Group;

(e) During the second meeting, the Group shall:

(i) Revise and finalize the "roadmap" for the effective use of guidance documents on risk assessment;

(ii) Make recommendations to the Secretariat on how to integrate the "roadmap" and tools for retrieval of guidance materials available in the Biosafety Information Resources Centre of the Biosafety Clearing-House that are relevant at the different stages of risk assessment;

(iii) Review the action plan referred to in subparagraph 1 (d) (iii) of this annex on specific aspects of risk assessment and risk management developed in accordance with the terms and procedures established in the first meeting of the Group;

(iv) Consider 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;

(v) Prepare a report for consideration by the fifth meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol;

2. The deliberations of the Ad Hoc Technical Expert Group shall be based primarily on:

(a) Submissions received in accordance with paragraph 5 of this decision;

(b) The reports of the regional and sub-regional workshops on capacity-building and exchange of experiences on risk assessment and risk management of living modified organisms (UNEP/CBD/BS/COP-MOP/4/INF/14-17) and the report of the Canada-Norway Workshop on Risk Assessment for Emerging Applications of Living Modified Organisms (UNEP/CBD/BS/COP-MOP/4/INF/13);

(c) Contribution received through the open-ended online forum, ad hoc discussion groups and real-time online regional conferences;

(d) Guidance materials available in the Biosafety Information Resource Centre of the Biosafety Clearing House;

(e) Any other relevant materials made available by the Secretariat.