Risk assessment and risk management

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

Noting the review of existing guidance materials relevant to risk assessment and risk management (UNEP/CBD/BS/COP-MOP/2/9), prepared by the Executive Secretary for the second meeting of the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety,

Recalling its decision to consider, at its second meeting, the development of guidance and a framework for a common approach in risk assessment and risk management (decision BS-I/12, annex, paragraph 4 (b)), and noting that there are various approaches for guidance on risk assessment and risk management, as reflected in paragraph 8 of review of existing guidance materials (UNEP/CBD/BS/COP-MOP/2/9),

Acknowledging that any guidance on risk assessment and risk management developed by the Conference of the Parties serving as the meeting of the Parties to the Protocol should support a harmonized approach, in accordance with annex III of the Protocol, taking into account internationally agreed principles and techniques developed by relevant international organizations and bodies,

Recalling that risk assessment and other scientific and technical expertise, and risk management, have been identified as key elements requiring concrete action under the Action Plan for Building Capacities for the Effective Implementation of the Cartagena Protocol on Biosafety (decision BS-I/5, annex I, paragraph 3),

Recalling also its decision I/9, adopted at its first meeting, requesting Parties to submit interim national reports on implementation of the Cartagena Protocol on Biosafety two years after the entry into force of the Protocol, and noting that the format for reporting includes a section on risk assessment and risk management,

1. Requests the Executive Secretary to include the materials listed in the annex of the review of existing guidance materials (UNEP/CBD/BS/COP-MOP/2/9) in the Biosafety Information Resource Centre on the Biosafety Clearing-House, and encourages Parties, other Governments and relevant organizations to contribute further to the Biosafety Information Resource Centre on the Biosafety Clearing-House, by registering additional guidance materials and other scientific and technical information;

2. Requests the Executive Secretary to convene, prior to the fourth 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, regional workshops on capacity-building and exchange of experiences on risk assessment and risk management of living modified organisms, taking into account the results of the meeting of the Ad Hoc Technical Expert Group on Risk Assessment referred to in paragraph 4 below, and also taking into account experience and expertise in the context of relevant international agreements and bodies;

3. Reminds Parties to submit their interim reports on implementation of the Protocol by 11 September 2005, in accordance with decision BS-I/9, and encourages Parties to include, in accordance with the section of the reporting format related to risk assessment and risk management, information on experiences and progress in implementing Articles 15 and 16, including any obstacles or impediments encountered;

4. Decides to establish an Ad Hoc Technical Expert Group on Risk Assessment, according to the specific terms of reference annexed to the present decision, and welcomes the generous offer of the Government of Italy to provide the necessary financial support for a meeting of the Group prior to the third meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol;

5. Requests the Executive Secretary to compile the information on risk assessment and risk management submitted by Parties in their interim national reports, for inclusion in a synthesis report for consideration by the Ad Hoc Technical Expert Group referred to in paragraph 4 above;

6. Requests the Executive Secretary to prepare for the third meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol, a pre-sessional paper regarding risk assessment and risk management that synthesizes:

(a) The findings of the meeting of the Ad Hoc Technical Expert Group on Risk Assessment referred to in paragraph 4 above;

(b) Information on experiences and progress in implementing Articles 15 and 16 received in the interim national reports under the Protocol, noting that this information will be reviewed in a synthesis report prepared in advance of the meeting of the Ad Hoc Technical Expert Group on Risk Assessment;

(c) The submissions on risk assessment and risk management received from Parties, other Governments and international organizations (UNEP/CBD/BS/COP-MOP/2/INF/2), as well as the synthesis of views and compilation of guidance materials (UNEP/CBD/BS/COP-MOP/2/9).

Annex

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

1. The Ad Hoc Technical Expert Group shall:

(a) Include experts from relevant international organizations and bodies as observers;

(b) Consider the nature and scope of existing approaches to risk assessment based on national experiences and existing guidance materials;

(c) Evaluate the relevance of existing approaches and guidance materials to risk assessment under the Protocol, and identify gaps in those existing approaches and guidance materials;

(d) Identify specific areas where limitations in capacity may be an impediment to effective implementation of the risk assessment provisions of the Protocol at national level, and where capacity-building activities may be particularly important,

(e) Submit a report for consideration by the third 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) Information provided in the interim national reports referred to in paragraphs 3 and 5 of this decision;

(b) Guidance materials listed in the annex to the review of existing guidance material relevant to risk assessment and risk management (UNEP/CBD/BS/COP-MOP/2/9);

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