Recalling Article 35 of the Protocol which requires the evaluation of the effectiveness of the Protocol, including an assessment of its procedures and annexes, to be undertaken at least every five years,
Recognizing that the first assessment and review, which was to be conducted in 2008, could not lead to a meaningful evaluation of the effectiveness of the Protocol due to the absence of a methodological approach and lack of sufficient experience in the implementation of the Protocol,
Recalling decision BS-IV/15 which requested the Executive Secretary to develop a methodological approach, draft criteria or indicators that could contribute to an effective second assessment and review of the Protocol,
1.Decides:
(a)That the scope of the second assessment and review of the effectiveness of the Protocol focus primarily on evaluating the status of implementation of core elements of the Protocol as identified in the annex below;
(b)That the evaluation should be based on information on the implementation of the Protocol gathered through the second national reports, the Biosafety Clearing-House, information that might be made available through the Compliance Committee in relation to its functions to review general issues of compliance, the capacity-building coordination mechanism and other relevant processes and organizations;
2.Requests the Executive Secretary to collect and compile information on the implementation of the Protocol and to commission the analysis of such compilation of information with a view to facilitating the second assessment and review of the effectiveness of the Protocol;
3.Decides also:
(a)To establish a regionally balanced ad hoc technical expert group, subject to the availability of funds, to: (i) review the analysis of information referred to in paragraph 2 above; and (ii) submit its recommendations to the sixth meeting of the Conference of the Parties serving as the meeting of the Parties for its consideration; and
(b)That the third assessment and review of the Protocol be conducted in conjunction with the mid term review of the implementation of the Strategic Plan at the eighth meeting of the Parties, using, among other things, information collected through the third national reports;
4.Urges Parties and invites other Governments and relevant international organizations to contribute, as appropriate, to the data collection processes by completing and submitting, in a timely manner, national reports, or by responding to a questionnaire and providing complete information on the implementation of the Protocol.
Annex
ELEMENTS AND CORRESPONDING INDICATORS FOR SECOND ASSESSMENT AND REVIEW
A.Coverage
Element 1. Geographic coverage of the Protocol and Protocols coverage of transboundary movements of LMOs:
(a)Number of Parties to the Protocol;
(b)Number of Parties that have designated national focal points;
(c)Number of Parties submitting timely national reports on their implementation of the Protocol;
(d)Number of Parties importing LMOs from non-Parties;
(e)Number of Parties exporting LMOs to non-Parties.
B.Domestic implementation of core procedures and annexes
Element 2. AIA procedures (or domestic regulatory frameworks consistent with the Protocol), in accordance with the Protocol, are established for the transboundary movement of LMOs for intentional introduction into the environment:
(a)Number of Parties that have put in place laws and regulations and/or administrative measures for operation of the AIA procedure;
(b)Number of Parties that have adopted a domestic regulatory framework consistent with the Protocol as regards the transboundary movement of LMOs for intentional introduction into the environment;
(c)Number of Parties that have designated competent national authorities;
(d)Number of Parties importing or exporting LMOs that do not have relevant laws and regulations in place governing transboundary movements of LMOs for intentional introduction into the environment;
(e)Regional trends in adopting AIA procedures or domestic regulatory frameworks consistent with the Protocol.
Element 3. AIA procedures (or domestic regulatory framework consistent with the Protocol) for the transboundary movement of LMOs for intentional introduction into the environment are operational and functioning:
(a)Number of Parties with domestic institutional and administrative (decision-making) arrangements in place to deal with AIA applications;
(b)Number of Parties with a budgetary allocation for the operation of their national biosafety framework;
(c)Number of Parties with permanent staff in place to administer their national biosafety frameworks (including AIA applications);
(d)Number of Parties that have processed AIA applications and reached decisions on import;
(e)Regional trends in operation and functioning of AIA procedures.
Element 4. Procedures for decision-making in relation to transboundary movements of living modified organisms intended for direct use as food or feed, or for processing (LMO-FFPs) are established and operational:
(a)Number of Parties that have taken final decisions regarding domestic use, including placing on the market, of LMO-FFPs that may be subject to transboundary movement;
(b)Number of Parties with a decision-making procedure specific to the import of LMO FFPs.
Element 5. Risk assessment procedures for LMOs are established and operational:
(a)Number of Parties with risk assessment guidance in place for LMOs;
(b)Number of Parties that have conducted risk assessments as part of a decision-making process regarding an LMO;
(c)Number of Parties with an advisory committee or other arrangements in place for conducting or reviewing risk assessment;
(d)Number of decisions in the Biosafety Clearing-House accompanied by a summary of the risk assessment of the LMO;
(e)Number of Parties with the necessary domestic capacity to conduct risk assessment;
(f)Number of Parties reporting having used Annex III of the Protocol or any other guidance on risk assessment agreed to by the Conference of the Parties serving as the meeting of the Parties to the Protocol;
(g)Regional trends in relation to risk assessment capacity.
Element 6. Procedures for the establishment of appropriate LMO risk management measures and monitoring are established and operational:
(a)Number of Parties that have authorized introductions of LMOs into the environment and that have requirements and/or procedures in place and enforced to regulate, manage and control risks identified in risk assessments;
(b)Number of Parties with capacity to detect and identify the presence of LMOs;
(c)Regional trends in relation to risk management capacity.
Element 7. Procedures for identifying and addressing illegal transboundary movements of LMOs are in place and operational:
(a)Number of Parties with domestic measures to prevent and penalize illegal transboundary movements, including through the regulation of transit and contained use;
(b)Number of Parties reporting having received information concerning cases of illegal transboundary movements of an LMO to or from territories under its jurisdiction;
(c)Number of Parties with capacity to detect illegal transboundary movements of LMOs (e.g. personnel, technical capacity).
Element 8. Procedures for preventing, identifying and addressing unintentional transboundary movements of LMOs are established and operational, including notification procedures and emergency measures:
(a)Number of Parties having notified to the Biosafety Clearing-House their contact points regarding unintentional transboundary movement of LMOs in accordance with Article 17;
(b)Number of Parties with a mechanism in place for notifying potentially affected States of actual or potential unintentional transboundary movements of LMOs;
(c)Number of instances of unintentional transboundary movements identified;
(d)Number of Parties with a mechanism to identify and determine significant adverse effects on biological diversity of any unintentional transboundary movements of LMOs;
Element 9. Appropriate requirements are established and implemented in relation to the Protocols requirements on the handling, transport, packaging and identification of LMOs:
(a)Number of Parties with requirements for handling, transport, packaging and identification of LMOs in place consistent with Article 18 of the Protocol and relevant subsequent decisions of the Conference of the Parties serving as the meeting of the Parties to the Protocol for:
(i)Contained use;
(ii)Intentional introduction into the environment;
(iii)LMO-FFPs.
Element 10. Procedures for notification of required information to the Biosafety Clearing-House are established and operational:
(a)Number of Parties that have allocated responsibilities for notification of information to the Biosafety Clearing House;
(b)Number of Parties that have in place systems for the management of biosafety information necessary for the implementation of the Protocol.
Element 11. Procedures and measures for promoting public awareness are being implemented:
(a)Number of Parties implementing public-awareness programmes or activities;
(b)Number of Parties providing for some level of public participation in decision-making processes on LMOs.
C.International level procedures and mechanisms
Element 12. Capacity-building Action Plan being effectively implemented:
(a)Amount of funding provided or received for supporting biosafety capacity-building activities and the impacts resulting from such funding.
(b)Number of Parties seeking assistance to be able to use experts from the roster of experts and number of Parties actually receiving such assistance;
(c)Number of Parties reporting using local expertise to undertake or review risk assessments and other activities relating to the implementation of the Protocol.
Element 13. Compliance Committee is functioning:
(a)Parties raise issues with the Compliance Committee concerning their own compliance with Protocol obligations;
(b)Compliance Committee has decision-making rules of procedure in place.
Element 14. The Biosafety Clearing-House is operational and accessible:
(a)Number of Parties and other users accessing the Biosafety Clearing-House on a regular basis, i.e. at least once a month;
(b)Number of Parties reporting difficulties accessing or using the Biosafety Clearing-House;
(c)Extent to which information on the Biosafety Clearing-House is reliable and up to date.
D.Impacts of transboundary movements of LMOs on biological diversity, taking also into account risks to human health
Element 15. Consideration should be given to the work on biodiversity indicators in the context of the Convention on Biological Diversity.
