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MOP 6 Decision BS-VI/12

BS-VI/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 decisions BS-IV/11 and BS-V/12 on risk assessment and risk management,

I.Further guidance on specific aspects of risk assessment

1.Takes note of the conclusions and recommendations of the open-ended online forum and the Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management and commends the progress made on the resulting Guidance on Risk Assessment of Living Modified Organisms, clearly understanding that:
(a)The Guidance is not prescriptive and does not impose any obligations on Parties;
(b)The Guidance will be tested nationally and regionally for further improvement in actual cases of risk assessment and in the context of the Cartagena Protocol on Biosafety;
2.Encourages Parties, other Governments and relevant organizations, as appropriate, to translate the Guidance into national languages and to make such translated versions available through the Biosafety Clearing-House for wide dissemination, in order to facilitate the testing of the Guidance at national, regional and subregional levels;
3.Also encourages Parties, other Governments and relevant organizations, through their risk assessors and other experts who are actively involved in risk assessment, to test the Guidance in actual cases of risk assessment and share their experiences through the Biosafety Clearing-House and the open-ended online forum;
4.Invites Parties, other Governments and relevant organizations to provide financial and technical assistance to developing country Parties and Parties with economies in transition to undertake, as appropriate, the testing activities referred to in paragraph 3 above;
5.Requests the Executive Secretary to:
(a)Develop appropriate tools to structure and focus the testing of the Guidance;
(b)Gather and analyse, in a transparent manner, feedback provided as a result of testing on the practicality, usefulness and utility of the Guidance, (i) with respect to consistency with the Cartagena Protocol on Biosafety; and (ii) taking into account past and present experiences with living modified organisms; and
(c)Provide a report on possible improvements to the Guidance for consideration by the Conference of the Parties serving as the meeting of the Parties to the Protocol at its seventh meeting;
6.Establishes the following mechanism for regularly updating the list of background documents to the Guidance in a transparent manner:
(a)On an annual basis, the Executive Secretary will invite Parties, non-Parties, relevant organizations and all Biosafety Clearing-House users, to propose relevant background materials that can be linked to specific sections of the Guidance;
(b)In the absence of any AHTEG on risk assessment and risk management, a regionally balanced group of fifteen experts in risk assessment (three experts per region) will be nominated by the Parties and selected by the Bureau of the Conference of the Parties serving as the meeting of the Parties to the Protocol to work online to examine the relevance of the proposed background documents. The members of the Group will work on an ongoing basis, renewable every four years;
(c)The Group will nominate a chair from among its members to lead deliberations transparently in approving, updating, rearranging or rejecting the proposed background materials in a justified manner;
(d)Documents on the list will be re-validated by the Group every five years or as appropriate. Documents not re-validated after this time period will, initially, be flagged for one year as "possibly outdated" and will subsequently be deleted from the list of background materials after an additional year;
(e)The Group will submit a report of its activities to each meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol;
7.Decides to extend the open-ended online forum, bring to a close the current AHTEG and establish a new AHTEG, that will serve until the seventh meeting of the Parties, in accordance with the terms of reference annexed hereto;
8.Requests the Executive Secretary to:
(a)With a view to achieving a balance of current and new members, select experts for the new AHTEG, in consultation with the Bureau of the Conference of the Parties serving as the meeting of the Parties to the Protocol, in accordance with paragraph 18 of the consolidated modus operandi of the Subsidiary Body on Scientific, Technical and Technological Advice of the Convention on Biological Diversity (decision VIII/10, annex III);
(b)Invite other Governments and relevant international organizations to participate in the open-ended online forum;
(c)Ensure that the participation of experts nominated by other Governments and relevant organizations to the open-ended online forum and AHTEG is in accordance with rules 6 and 7 of the rules of procedure for meetings of the Conference of the Parties serving as the meeting of the Parties to the Protocol;
(d)Ensure that all online discussions of the open-ended online forum are moderated to enhance their efficiency; and
(e)Undertake temporary measures for updating the list of background documents in the time it takes to establish the membership of the new AHTEG;

II.Capacity-building in risk assessment and risk management

Acknowledging the revised training manual on risk assessment of living modified organisms and the concept of an e-training tool based on the revised training manual,
Welcoming the reports of the subregional workshops on capacity-building and exchange of experiences on risk assessment held in the Caribbean, Latin American and African (Anglophone countries) subregions and taking note of the recommendations from the workshops,
Taking note of the recommendations of the open-ended online forum and the Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management regarding capacity-building in risk assessment and risk management,
9.Requests the Executive Secretary, subject to the availability of funds, to:
(a)Convene, at the earliest convenient date, the remaining training courses on risk assessment for the African (Francophone countries) and the Central and Eastern Europe subregions to enable the countries concerned 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;
(b)Cooperate with the open-ended online forum and AHTEG to develop a package that aligns the Guidance on Risk Assessment of Living Modified Organisms (e.g. the Roadmap) with the training manual "Risk Assessment of Living Modified Organisms" in a coherent and complementary manner, with the clear understanding that the Guidance is still being tested;
(c)Follow up on training by gathering additional feedback from Parties on the practicality, usefulness and utility of the Guidance and training manual through online discussions or other means, as appropriate; and
(d)Conduct workshops on risk assessment and risk management at international, regional and/or subregional levels, using the package to carry out training courses for risk assessors, taking into consideration real case studies in risk assessment and how to apply the Guidance in the context of the decision-making process under the procedures of the Protocol;
10.Invites Parties, other Governments and international organizations to provide financial and technical assistance to developing country Parties and Parties with economies in transition to implement the above capacity-building activities, as appropriate;

III.Identification of living modified organisms or specific traits that (i) may have or (ii) are not likely to have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health

11.Invites Parties and encourages other Governments and relevant organizations to provide the Executive Secretary with scientific information that may assist in the identification of living modified organisms or specific traits that may have or 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;
12.Requests the Executive Secretary to create sections in the Biosafety Clearing-House where such information could be submitted and easily retrieved;

IV.Status of implementation of risk assessment and risk management provisions

13.Requests the Executive Secretary to conduct an online survey on the status of the implementation of operational objectives 1.3, 1.4 and 2.2 of the Strategic Plan for the Cartagena Protocol on Biosafety for the period 2011-2020, where data is missing and cannot be retrieved through existing sources of information available to the Secretariat, with a view to establishing baselines for, and collecting data on, the indicators concerned.

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 on the following issues in the given order of priority:
(a)Provide input, inter alia, to assist the Executive Secretary in his task to structure and focus the process of testing the guidance, and in the analysis of the results gathered from the testing;
(b)Coordinate, in collaboration with the Secretariat, the development of a package that aligns the Guidance on Risk Assessment of Living Modified Organisms (e.g. the Roadmap) with the training manual "Risk Assessment of Living Modified Organisms" in a coherent and complementary manner, for further consideration of the Parties, with the clear understanding that the Guidance is still being tested;
(c)Consider the development of guidance on new topics of risk assessment and risk management, selected on the basis of the Parties' needs and their experiences and knowledge concerning risk assessment.
2.Subject to the availability of funds, the Ad Hoc Technical Expert Group on Risk Assessment and Risk Management shall meet once face-to-face prior to the seventh 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 a view to developing and achieving the following:
(a)Moderated online discussions relating to the testing of the practicality, usefulness and utility of the Guidance;
(b)A package that aligns the Guidance on Risk Assessment of Living Modified Organisms (e.g. the Roadmap) with the training manual "Risk Assessment of Living Modified Organisms" in a coherent and complementary manner; and
(c)A recommendation on how to proceed with respect to the development of further guidance on specific topics of risk assessment, selected on the basis of the priorities and needs indicated by the Parties with the view of moving toward the operational objectives 1.3. and 1.4 of the Strategic Plan and its outcomes.

Reporting

4.The open-ended online forum and the Ad Hoc Technical Expert Group on Risk Assessment and Risk Management shall submit their final reports detailing the activities, outcomes and recommendations for consideration by the seventh meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol.
5.The Ad Hoc Technical Expert Group on Risk Assessment and Risk Management shall also operate the mechanism set out in paragraph 6 of decision BS-VI/12 for the regular updating of the background documents to the Guidance and submit a report on its activities related to updating the background documents to the Guidance to the seventh meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol.
BS-VI/11 BS-VI/13

  • United Nations
  • United Nations Environment Programme