Capacity-building
The Conference of the Parties serving as the meeting of the
Parties to the Cartagena Protocol on Biosafety,
Welcoming the preparatory work and the recommendations
by the Intergovernmental Committee for the Cartagena Protocol on
Biosafety (ICCP) on the issue of capacity-building as well as the
documents prepared by the Executive Secretary,
Recognizing the urgent need to address the critical
capacity-building requirements of developing country Parties, in
particular the least developed and the small island developing
States among them, and Parties with economies in transition,
including countries amongst these that are centres of origin and
centres of genetic diversity, for effective implementation of the
Protocol,
Recognizing also the relationship between
capacity-building and the ability of developing country Parties, in
particular the least developed and the small island developing
States among them, and Parties with economies in transition to
comply with the provisions of the Protocol,
Taking note of the capacity-building needs and
priorities with regard to the Biosafety Clearing-House submitted by
Parties and other Governments,
Emphasizing the importance of ensuring that
capacity-building initiatives are demand-driven and responding to
the needs and priorities identified by the recipient countries;
Welcoming the biosafety capacity-building initiatives
already supported by Global Environment Facility and its
Implementing Agencies and by bilateral development agencies and
other organizations;
Taking note of decision VI/17 of the Conference of the
Parties, requesting the Global Environment Facility to provide
financial resources for national capacity-building in biosafety, in
particular for enabling effective participation in the Biosafety
Clearing-House and in the implementation of the Action Plan for
Building Capacities for the Effective Implementation of the
Cartagena Protocol on Biosafety;
Taking note also of the initial gap analysis by the
Executive Secretary of the capacity-building initiatives and the
capacity-building needs and priorities submitted to the Biosafety
Clearing-House by Parties and Governments as an important step in
identifying areas where further efforts would be needed;
Emphasizing the importance for Parties and other
Governments to develop and implement concrete and mutually
supportive capacity-building activities;
Emphasizing also the need for a coordinated approach
towards capacity-building at all levels in order to develop
possible synergies and promote partnerships among different
capacity-building efforts and funding initiatives for the effective
implementation of the Protocol,
Welcoming the initial activities undertaken by the
Executive Secretary to facilitate and promote coordination of
existing capacity-building initiatives in biosafety,
Action Plan for Building Capacities for Effective
Implementation of the Protocol
1. Adopts the Action Plan for Building Capacities for
the Effective Implementation of the Cartagena Protocol on Biosafety
endorsed by the ICCP, as contained in annex I to the present
decision;
2. Invites Parties, other Governments, international
and regional organizations, non-governmental organizations, private
sector and scientific organizations and other relevant bodies to
support the effective implementation of the Action Plan, taking
into account the potential roles as contained in annex II to the
present decision, of different entities in facilitating
capacity-building, and recognizing the need for synergies between
the capacity-building activities of the private sector and civil
society and national programmes and priorities;
3. Welcomes the progress made in implementing the
Action Plan, summarized in the note by the Executive Secretary on
capacity-building (UNEP/CBD/BS/COP-MOP/1/6), and invites
Parties, other Governments and relevant organizations to take
further measures towards its effective implementation;
4. Takes note of the gaps in the implementation of the
Action Plan identified in the initial analysis in the note by the
Executive Secretary (UNEP/CBD/BS/COP-MOP/1/6), and invites
Parties, other Governments and relevant organizations to
take collaborative actions to
addressthose gaps;
5. Decides to undertake a comprehensive review and
possible revision of the Action Plan and at its third meeting, on
the basis of the progress report to be prepared by the Executive
Secretary and also on the basis of the capacity needs and
priorities submitted by Parties and other Governments and decides
to, at the same time, review the guidance to the financial
mechanism with a view to updating it, as
appropriate;
6. Invites Parties and other Governments that have not
yet submitted their capacity-building needs and priorities to the
Biosafety Clearing-House to do so as soon as possible;
7. Urges Parties and other governments to review their
needs and priorities periodically and update their records in the
Biosafety Clearing-House accordingly;
8. Encourages Parties and other Governments to develop
national strategic plans and programmes to address their identified
needs and priorities;
9. Invites Parties, other Governments and relevant
organizations in a position to provide assistance to developing
country Parties, in particular the least developed and the small
island developing States among them, and Parties with economies in
transition to, as an initial step, review the information on the
needs and priorities submitted by those countries to the Biosafety
Clearing-House when developing assistance programmes;
10. Urges Parties, other Governments and relevant
organizations to register in the Biosafety Clearing-House relevant
information on their existing biosafety capacity-building
initiatives, including reports on the achievements, lessons learned
and opportunities for cooperation as well as suggestions on how to
enhance capacity building for the effective implementation of the
Protocol;
11. Invites Parties, other Governments and
organizations to use, as appropriate, the implementation tool kit
contained in annex III to the present decision;
12. Invites developed country Parties, Governments, the
Global Environment Facility, other donor agencies and relevant
organizations to provide financial support and other assistance to
developing country Parties, in particular the least developed and
the small island developing States among them, and Parties with
economies in transition, including countries amongst these that are
centres of origin and centres of genetic diversity, to develop and
implement capacity-building activities, including organization of
national, regional and inter-regional capacity building workshops
and preparatory meetings;
13. Welcomes the support already provided by the Global
Environment Facility for demonstration projects on implementation
of the national biosafety frameworks and invites the
Global Environment Facility to extend such support to other
eligible countries;
14. Urges the Global Environment Facility to ensure a
rapid implementation of its initial strategy for assisting
countries to prepare for the ratification and implementation of the
Protocol, and to support capacity-building for the establishment of
national components of the Biosafety Clearing-House in a flexible
manner, and to provide additional support for the development
and/or strengthening of existing national and regional centres for
training; regulatory institutions; risk assessment and risk
management; infrastructure for the detection, testing,
identification and long-term monitoring of living modified
organisms; legal advice; decision-making; handling of
socio-economic considerations; awareness-raising and technology
transfer for biosafety;
15. Requests the Executive Secretary to prepare a
progress report on the implementation of the
ActionPlan, on the basis of the
submissions from Parties, other Governments and relevant
organizations, for consideration at its third meeting;
16. Requests also the Executive Secretary to compile,
on the basis of the information submitted by Parties and other
Governments to the Biosafety Clearing-House, a summary report on
the capacity needs and priorities for consideration by the
Conference of the Parties serving as the meeting of the Parties to
the Protocol at its regular meetings, and make it available to
donor Governments and relevant organizations, as appropriate;
17. Welcomes the Outreach Strategy for the Cartagena
Protocol on Biosafety developed by the Executive Secretary and
requests the Executive Secretary to advance its
implementation with the view to promoting broader awareness of the
Protocol and fostering the active participation and support of a
broad range of stakeholders in the implementation of the
Protocol;
Coordination Mechanism
18. Adopts the Coordination Mechanism for the
implementation of the Action Plan for Building Capacities for the
Effective Implementation of the Cartagena Protocol on Biosafety,
contained in annex IV to the present decision;
19. Invites Parties, other Governments and relevant
organizations to provide financial contributions and other support
to facilitate the implementation of the Coordination Mechanism;
20. Urges Parties, Governments and relevant
organizations to register and update information on their biosafety
capacity-building activities in the Biosafety Clearing-House,
including capacity-building projects, opportunities, and other
relevant information;
21. Welcomes the generous offer by the Government of
Switzerland to sponsor a coordination meeting for representatives
of academic and research institutions actively involved in
education, training and research programmes in biotechnology and
biosafety in the automn of 2004;
22. Invites Parties, other Governments and relevant
organizations to actively participate in and to support the
implementation of the Coordination Mechanism and to share their
expertise and resource materials through the Mechanism;
23. Urges Parties, other Governments and relevant
organizations to establish or strengthen, as appropriate,
corresponding national or regional-level coordination mechanism in
order to promote synergies between existing capacity-building
initiatives;
24. Requests the Executive Secretary to discharge, in a
phased manner and within existing resources, the functions
specified in the annex IV to the present decision in collaboration
with other relevant agencies, to implement the Coordination
Mechanism;
25. Requests the Executive Secretary to prepare a
report on the progress made, and lessons learned, in implementing
the Coordination Mechanism for consideration by the second meeting
of the Conference of the Parties serving as the meeting of the
Parties to the Protocol;
Indicators for monitoring implementation of the
Action Plan
26. Takes note of the preliminary set of criteria and
indicators for monitoring implementation of the Action Plan,
contained in the annex V to the present
decision;
27. Invites Parties, other Governments, and relevant
organizations to use, as appropriate, the indicators referred to in
the paragraph 26 above to monitor their biosafety capacity-building
initiatives being implemented in support of the Action Plan;
28. Invites Parties, other Governments, and relevant
organizations to submit to the Executive Secretary, and to share
through the Biosafety Clearing-House, their experience in using the
preliminary set of indicators;
29. Requests the Executive Secretary to prepare, for
consideration at the fourth meeting of the Conference of the
Parties to the Convention serving as the meeting of the Parties to
the Protocol, a report on the operational experience in using the
above-mentioned indicators and proposals for their further
development and refinement, on the basis of submissions by Parties,
other Governments, and relevant organizations.
Annex I
ACTION PLAN FOR BUILDING
CAPACITIES FOR THE EFFECTIVE IMPLEMENTATION OF THE CARTAGENA
PROTOCOL ON BIOSAFETY
1. Objective of the Action Plan
1. The objective of this Action Plan is to facilitate and
support the development and strengthening of capacities for the
ratification and effective implementation of the Cartagena Protocol
on Biosafety at the national, sub regional, regional and global
levels in a timely manner. In this regard, the provision of
financial, technical and technological support to developing
countries, in particular the least developed and small island
developing states among them, as well as countries with economies
in transition, including countries amongst these that are centres
of origin and centres of genetic diversity, is essential.
2. To achieve the objective, this action plan aims at
identifying country needs, priorities, and mechanisms of
implementation and sources of funding.
2. Key elements requiring
concrete action
3. The following key elements are meant to be considered in
a flexible manner, based on a demand-driven approach, taking into
account the different situations, capabilities and stages of
development of each country.
(a) Institutional capacity-building:
(i) Legislative and regulatory framework;
(ii) Administrative framework;
(iii) Technical, scientific and telecommunications
infrastructures;
(iv) Funding and resource management;
(v) Mechanisms for follow-up, monitoring and assessment;
(b) Human-resources development and training;
(c) Risk assessment and other scientific and technical
expertise;
(d) Risk management;
(e) Awareness, participation and education at all levels
including for decision makers, stakeholders and general public;
(f) Information exchange and data management including full
participation in the Biosafety Clearing-House;
(g) Scientific, technical and institutional collaboration at sub
regional, regional and international levels;
(h) Technology transfer;
(i) Identification of living modified organisms;
(j) Socio-economic considerations.
3. Processes/steps
4. The following processes/steps should be undertaken within
appropriate timeframes:
(a) Identification of capacity needs, including the needs that
are not covered prior to the second meeting of ICCP;
(b) Prioritization of the key elements by each country prior to
the first meeting of the Conference of the Parties to the
Convention serving as the meeting of the Parties to the
Protocol;
(c) Sequencing of actions, including timelines for the operation
of capacity-building prior to first meeting of the Conference of
the Parties to the Convention serving as the meeting of the Parties
to the Protocol;
(d) Identification of the coverage and gaps in capacity-building
initiatives and resources that could support the ratification and
implementation, prior to first meeting of the Conference of the
Parties to the Convention serving as the meeting of the Parties to
the Protocol, from the following:
(i) Global Environment Facility (GEF);
(ii) Multilateral agencies;
(iii) Other international sources;
(iv) Bilateral sources;
(v) Other stakeholders;
(vi) National sources;
(a) Enhancing the effectiveness and adequacy of financial
resources to be provided by multilateral and bilateral donors and
other donors to developing countries, in particular the least
developed and small island developing States among them, as well as
countries with economies in transition
taking, including countries amongst these
thatare centres of origin and centres of
genetic diversity;
(f) Enhancing synergies and coordination of capacity-building
initiatives;
(g) Development of indicators for evaluating capacity-building
measures.
4. Implementation
5. The activities hereunder are not listed in any order of
priority:
4.1 National level
(a) Development of national regulatory frameworks on
biosafety;
(b) Development and/or strengthening of institutional,
administrative, financial and technical capacities, including the
designation of national focal points and competent national
authorities;
(c) Establishment of a mechanism to inform all stakeholders;
(d) Appropriate participation of all relevant stakeholders;
(e) A mechanism for handling requests or notifications,
including risk assessment and decision-making, as well as public
information and participation;
(f) Mechanisms for monitoring and compliance;
(g) A short- and long-term assessment for internal and external
funding;
4.2 Subregional and regional
levels
(a) Regional and subregional collaborative arrangements
(b) Regional and subregional advisory mechanisms
(c) Regional and subregional centres of excellence and
training
(d) Regional and subregional website and database
(e) Mechanisms for regional and subregional coordination and
harmonization of regulatory frameworks, where appropriate.
4.3 International level
(a) Effective functioning of the Biosafety Clearing-House;
(b) Development/updating of international guidance (by UNEP,
FAO, IUCN and others);
(c) Strengthening South-South cooperation;
(d) Development and effective use of the roster of experts
(e) Regular review and provision of further guidance by the
Conference of the Parties to the Convention serving as the meeting
of the Parties to the Protocol.
5. Monitoring and
coordination
6. Because of the multitude of different actors undertaking
different capacity building initiatives, mutual information,
coordination and regular monitoring will be promoted in order to
avoid duplications and to identify gaps. This exercise will lead to
a focus of capacity building on biosafety, ratification, and
implementation of the Cartagena Protocol on Biosafety. The
Secretariat and the Biosafety Clearing-House will be actively
involved in the process.
7. The Secretariat will prepare, on the basis of Governments'
submissions, a report on the steps taken by countries,
multilateral/bilateral and other international sources, towards
implementation of the Action Plan and submit a report to the
Conference of the Parties servicing as the meeting of the Parties
to the Protocol so that it identifies whether the actions listed
under section 4 have been carried out successfully and
effectively.
Appendix
POSSIBLE SEQUENCE OF ACTIONS
Recognizing that the sequence of action necessary to
ratify and implement the Protocol is to be decided by Parties
according to their national needs,
Cognizant of the urgent need to build capacities in
developing countries, in particular the least developed and small
island developing States among them, as well as countries with
economies in transition, including countries amongst these that are
centres of origin and centres of genetic diversity,
Building on the identified elements in the Action Plan
and without prejudice to the timeframes indicated therein,
As an aid to assist countries to establish national priorities
and to facilitate regional and subregional activities the following
sequence of actions based on experience and past practice is
proposed for consideration.
POSSIBLE SEQUENCING OF
ACTIVITIES IDENTIFIED IN THE ACTION PLAN
Each activity has associated with it specific objectives/tasks
identified in the Indicative Framework and associated documents
which will facilitate priority setting by countries and enable the
establishment of a timetable for capacity development. This
sequence does not establish priorities of action to be taken by
countries.
A. National level
1. Assessment of effectiveness and adequacy of existing
capacity.
2. Assessment of the short- and long-term requirements for
internal and external funding.
3. Development of timelines.
4. Development of national regulatory frameworks on
biosafety.
5. Development and/or strengthening of institutional,
administrative, financial and technical capacities, including the
designation of national focal points and competent authorities.
6. A mechanism for handling requests or notifications, including
risk assessment and decision-making, as well as public information
and participation.
7. Mechanisms for monitoring and compliance.
8. Establishment of a mechanism to inform all stakeholders.
9. Appropriate participation of all relevant stakeholders.
B. Regional and subregional
levels
10. Assessment of national, bilateral and multilateral
funding.
11. Regional website and database.
12. Mechanisms for regional and sub regional coordination and
harmonization of regulatory frameworks, where appropriate.
13. Regional and subregional collaborative arrangements.
14. Regional and subregional advisory mechanisms.
15. Regional and subregional centres of excellence and
training.
C. International level
16. Effective functioning of the Biosafety Clearing-House.
17. Enhancing the effectiveness and adequacy and coordination of
financial resources to be provided by multilateral and bilateral
donors and other donors to developing countries, in particular the
least developed and small island developing States
amongthem and countries with economies in
transition, including countries amongst these that are centres of
origin and centres of genetic diversity.
18. Development and effective use of the roster of experts.
19. Enhancing synergies and coordination of capacity-building
initiatives.
20. Strengthening South-South cooperation.
21. Development/updating of international guidance (by UNEP,
FAO, IUCN and others).
22. Regular review and provision of further guidance by the
Conference of the Parties to the Convention serving as the meeting
of the Parties to the Protocol.
Annex II
THE ROLE OF DIFFERENT ENTITIES IN SUPPORTING
CAPACITY-BUILDING
23. The present annex summarizes, in a point-by-point list form,
the views of Parties and governments regarding the roles which
different entities couldplay to
facilitate capacity-building to assist countries in preparing for
the entry into force of the Protocol and in its implementation.
2. The role of the Conference of the Parties serving as the
meeting of the Parties to the Protocol:
(a) Assuming the overall responsibility for decisions regarding
the establishment of the work programme related to
capacity-building and evaluation of its implementation, recognizing
the role of other relevant organizations and instruments;
(b) Setting norms for harmonization, where appropriate;
(c) Developing appropriate formats to build capacity and
encouraging consistency of standards in such matters as risk
assessment and information exchange;
(d) Revising and updating the capacity-building framework in the
light of responses to the questionnaire and the outcome of
inter-sessional workshops and projects;
(e) Providing general guidelines from an international
perspective;
(f) Gathering information necessary to determine what
capacity-building measures would be the most effective in assisting
countries to implement the provisions of the Protocol, including
information on national priority capacity needs and how to meet
them.
3. The role of the Secretariat:
(g) Providing an administrative framework for creation of
technical and scientific capacity;
(h) Implementing the Biosafety Clearing-House, taking account of
priority needs regarding the capacities of Parties and Governments
for access to and use of the Biosafety Clearing-House and the views
of Parties and Governments on monitoring its progress;
(i) Administering the Biosafety Clearing-House;
(j) Undertaking further synthesis and analysis of the identified
needs of countries for implementation of the Protocol, and
available means for assistance and information exchange;
(k) Providing technical assistance to Parties and other
Governments to help them in conducting their needs assessments;
(l) Serving as a focal point for organizations to submit
information to be made public as regards capacity-building
initiatives for the implementation of the Protocol, as well as for
identifying needs for capacity-building;
(m) Facilitating the flow of information;
(n) Promoting synergies and keeping countries abreast of
important developments and opportunities with respect to
capacity-building, including the roster of experts;
(o) Facilitating the functioning of the roster of experts;
(p) Implementing the relevant decisions of the Conference of the
Parties serving as the meeting of the Parties to the Protocol;
(q) Cooperating with the projects of the GEF implementing
agencies on national biosafety frameworks;
(r) Facilitating and promoting collaboration and coordination
among existing initiatives on capacity-building; and
(s) Providing coordination and leadership and suggesting ways
and means to build capacity in countries, taking into account the
decisions of the Conference of the Parties serving as meeting of
the Parties to the Protocol.
4. Subject to the decisions of the Conference of the Parties,
and in accordance with its mandate, the role of the Global
Environment Facility (GEF) includes:
(b) Providing funding and other assistance to build necessary
legislative and administrative frameworks, and for training in risk
assessment and risk management;
(c) Deciding on further areas for financial support for
capacity-building in accordance with the identified priority needs
of developing countries and countries with economies in transition,
responses to the questionnaires, the outcomes of inter-sessional
workshops, and its previous pilot project on biosafety;
(d) Implementing the GEF Strategy to assist countries to ratify
and implement the Cartagena Protocol on Biosafety;
(e) Facilitating the provision of technical support; and
(f) Facilitating the use of existing and developing regional
networks.
5. The role of other bilateral and multilateral donors, as
mutually agreed with recipient Parties and Governments, as
appropriate:
(a) Providing funding and other assistance to Parties,
governments and to the Secretariat, for relevant activities;
(b) Co-financing or providing matching funds for building
scientific capacity at the sub regional level, including sponsoring
regional and subregional workshops;
(c) Providing short- or long-term experts to advise on
identified needs and demands for assistance on specific issues,
including those listed in Article 22 of the Protocol;
(d) Reinforcing collaboration among capacity-building projects
on biotechnology and biosafety in order to avoid duplication and to
efficiently use the limited resources available.
6. The role of intergovernmental organizations as mutually
agreed with recipient Parties and Governments, as appropriate:
(g) Assisting national authorities of Parties to take
decisions;
(h) Sharing "best practices", models and information pertinent
to relations between obligations under trade agreements and
obligations under the Protocol;
(i) Developing advice or standards on particular technical or
regulatory issues: e.g., the work of the Organisation for Economic
Co-operation and Development (OECD) on a unique identifier for LMOs
and on Consensus Documents on common elements of risk assessment
for particular species;
(j) Contributingto the activities of
the GEF initial strategy on biosafety, in line with the terms
agreed by the GEF Council and relevant decisions taken by the
Conference of the Parties serving as the meeting of the Parties to
the Protocol;
(k) Providing access to
databasescontaining information relevant
to implementation of the Protocol: e.g. OECD's Biotrack, the
International Centre for Genetic Engineering and Biotechnology
(ICGEB), the UNIDO Biosafety Information Network and Advisory
Service (BINAS);
(l) Developing common principles for public participation and
access to information: e.g. the work of the United Nations Economic
Commission for Europe under the Aarhus Convention on Access to
Information, Public Participation in Decision-making and Access to
Justice in Environmental Matters;
(m) Promoting synergy and mutual supportiveness among the
various organizations and instruments concerned with risk analysis
in relation to living modified organisms, including the
International Plant Protection Convention (IPPC), the Office
International des Epizooties (OIE), the Food and Agriculture
Organization of the United Nations (FAO) and the Codex Alimentarius
Commission;
(n) Reinforcing collaboration among capacity-building projects
on biotechnology and biosafety in order to avoid
duplicationand to efficiently use the
limited resources available; and
(o) Providing co-financing for capacity-building activities.
7. The role of regional networks as mutually agreed with
relevant Parties and Governments, as appropriate:
(a) Promoting harmonization of technical, legal and scientific
mechanisms in the countries;
(b) Identifying and disseminating information related to best
practices in the development of national biosafety frameworks,
procedures for risk assessment and risk management,
decision-taking, information exchange, and the use of human
resources;
(c) Developing regional centres that enable/ensure sharing of
expertise and information as well as experiences and concerns;
(d) Participating in the development of the Biosafety
Clearing-House; and
(e) Providing co-financing for capacity-building activities.
8. The role of non-governmental organizations as mutually agreed
with relevant Parties and Governments, as appropriate:
(f) Cooperating in consensus-building and assisting in raising
public education and awareness;
(g) Participating in and assisting in national and regional
efforts to implement the Protocol, including helping to implement
the Biosafety Clearing-House;
(h) Contributing to guidance on Protocol implementation
issues;
(i) Integrating the views and interests of wider stakeholders,
including indigenous and local communities, through increased
public awareness, education and participation in decision-making
and the development of policy and procedures;
(j) Representing specialist or sectoral interests in relation to
risk assessmentand risk management
issues;
(k) Reinforcing collaboration among capacity-building projects
on biotechnology and biosafety in order to avoid duplication and to
efficiently use the limited resources available;
(l) Associating with capacity-building initiatives, ensuring
public participation and promoting public awareness on biosafety
issues; and
(m) Providing co-financing for capacity-building activities.
9. The role of private sector/industry as mutually agreed with
relevant Parties and Governments, as appropriate:
(a) Participating in and assisting in national and regional
efforts to implement the Protocol;
(b) Providing technical advice concerning identification,
detection and analytical assessment and for monitoring;
(c) Improving capabilities of accessing and handling electronic
information;
(d) Undertaking risk assessment, and addressing information
needs and concerns of industry;
(e) Associating with initiatives on capacity-building and
sharing experience with risk assessment and management of LMOs;
(f) Providing co-financing for capacity-building activities;
(g) Participating in and assisting in national and regional
efforts helping to implement the Biosafety Clearing-House;
(h) Reinforcing collaboration among capacity-building projects
on biotechnology and biosafety in order to avoid duplication and to
efficiently use the limited resources available; and
10. The role of scientific/academic institutions:
(a) Promoting public awareness and implementing training and
education activities;
(b) Developing of centres of expertise and excellence for
particular risk assessment and risk management issues;
(c) Providing participants for the roster of experts;
(d) Implementing exchange and scholarship programmes aimed at
enhancing the teaching and research capacities of higher education
and other private and public institutions in developing countries
and countries with economies in transition as regards biosafety
related issues;
(e) Cooperating on research and information exchange on
socio-economic impacts, especially on indigenous and local
communities;
(f) Assisting in training and conducting risk assessment,
research in LMOs for improved crop production;
(g) Participating in capacity-building initiatives as well as in
other activities in relation with the implementation of the
Protocol; and
(h) Providing co-financing for capacity-building activities;
(i) Supporting the above activities undertaken in developing
country Parties, in particular the least developed and the small
island developing States among them, and Parties with economies in
transition, including countries amongst these that are centres of
origin and centres of genetic diversity, ensuring that in
undertaking such activities the expertise available in those
countries is utilised first.
Annex III
IMPLEMENTATION TOOL KIT
This implementation tool kit provides a compilation, as a
checklist, of obligations found in the Cartagena Protocol on
Biosafety. These obligations are organized in the following
categories:
· Administrative tasks (initial and future)
· Legal requirements and/or undertakings
· Procedural requirements (AIA and Article 11)
I. ADMINISTRATIVE
TASKS
| | Tasks | Article | Check |
| | Initial
actions | | |
1. | Designate one national authority responsible for liaison with
the Secretariat and provide name/address to Secretariat. | 19(1),(2) | |
2. | Designate one or more competent authorities responsible for
performing administrative functions under the Protocol and provide
name(s)/address(es) to the Secretariat. If more than one, indicate
the types of LMOs for which each competent authority is
responsible. | 19(1),(2) | |
3. | Provide to the Biosafety Clearing-House: - any relevant existing laws, regulations or guidelines,
including those applicable to the approval of LMOs-FFP; and - any bilateral, regional or multilateral agreements or
arrangements. | 20(3)(a)-(b), 11(5), 14(2) | |
4. | Specify to the Biosafety Clearing-House cases in which import
may take place at the same time as the movement is notified. | 13(1)(a) | |
5. | Specify to the Biosafety Clearing-House imports of LMOs exempted
from the AIA procedures. | 13(1)(b) | |
6. | Notify the Biosafety Clearing-House if domestic regulations
shall apply with respect to specific imports. | 14(4) | |
7. | Provide the Biosafety Clearing-House with a point of contact for
receiving information from other States on unintentional
transboundary movements in accordance with Article 17. | 17(2) | |
8. | Notify the Secretariat if there is a lack of access to the
Biosafety Clearing-House and hard copies of notifications to the
Clearing House should be provided. | (e.g., 11(1)) | |
| | Follow-up
actions | | |
9. | Provide to the Biosafety Clearing-House: - Summaries of risk assessments or environmental reviews of LMOs
generated by regulatory processes and conducted in accordance with
Art. 15; - Final decisions concerning the import or release of LMOs;
and - Article 33 reports. | 20(3)(c)-(e) | |
10. | Make available to the Biosafety Clearing-House information
concerning cases of illegal transboundary movements. | 25(3) | |
11. | Monitor the implementation of obligations under the Protocol and
submit to the Secretariat periodic reports at intervals to be
determined. | 33 | |
12. | Notify the Biosafety Clearing-House of any relevant changes to
the information provided under part I above. | | |
II. LEGAL REQUIREMENTS AND/OR
UNDERTAKINGS
| | Tasks | Article | Check |
1. | Ensure that the development, handling, transport, use, transfer
and release of LMOs are undertaken in a manner that prevents or
reduces the risks to biological diversity, taking also into account
risks to human health. | 2(2) | |
2. | Ensure that there is a legal requirement for the accuracy of
information provided by domestic exporters for purposes of
notifications for export to another country and by domestic
applicants for domestic approvals for LMOs that may be exported as
LMOs-FFP. | 8(2) 11(2) | |
3. | Ensure that any domestic regulatory framework used in place of
the AIA procedures is consistent with the Protocol. | 9(3) | |
4. | Ensure that AIA decisions are taken in accordance with Article
15. | 10(1) | |
5. | Ensure that risk assessments are carried out for decisions taken
under Article 10 and that they are carried out in a scientifically
sound manner. | 15(1),(2) | |
6. | Establish and maintain appropriate mechanisms, measures and
strategies to regulate, manage and control risks identified in risk
assessments associated with the use, handling and transboundary
movement of LMOs under the Protocol. | 16(1) | |
7. | Take appropriate measures to prevent the unintentional
transboundary movements of LMOs, including measures such as
requiring a risk assessment prior to the first release of an
LMO. | 16(3) | |
8. | Endeavour to ensure that LMOs, whether imported or locally
developed, have undergone an appropriate period of observation that
is commensurate with its life cycle or generation time before it is
put to its intended use. | 16(4) | |
9. | Take appropriate measures to notify affected or potentially
affected States, the Biosafety Clearing-House, and, where
appropriate, relevant international organizations, when there is an
occurrence within its jurisdiction that leads or may lead to an
unintentional transboundary movement of and LMO that is likely to
have significant adverse effects on the sustainable use and
conservation of biodiversity, taking also into account risks to
human health in such States. | 17(1) | |
10. | Take necessary measures to require that LMOs that are subject to
transboundary movement under the Protocol are handled, packaged and
transported under conditions of safety, taking into account
relevant international rules and standards. | 18(1) | |
11. | Take measures to require that documentation accompanying
LMOs-FFP - clearly identifies that they "may contain" LMOs and are not
intended for intentional introduction into the environment; and - provides a contact point for further information. | 18(2)(a) | |
12. | Take measures to require that documentation accompanying LMOs
destined for contained use: - Clearly identifies them as LMOs; - Specifies any requirements for their safe handling, storage,
transport and use; - Provides a contact point for further information; and - Provides the name and address of individuals or institutions
to which they are consigned. | 18(2)(b) | |
13. | Take measures to require that documentation accompanying LMOs
that are intended for intentional introduction in the environment
and any other LMOs within the scope of the Protocol: - Clearly identifies them as LMOs - Specifies the identify and relevant traits and/or
characteristics; - Provides any requirements for the safe handling, storage,
transport and use; - Provides a contact point for further information; - Provides, as appropriate, the name and address of the importer
and exporter; and - Contains a declaration that the movement is in conformity with
the requirements of the Protocol. | 18(2)(c) | |
14. | Provide for the designation of confidential information by
notifiers, subject to the exclusions set forth in Article
21(6). | 21(1),(6) | |
15. | Ensure consultation with notifiers and review of decisions in
the event of disagreement regarding claims of confidentiality. | 21(2) | |
16. | Ensure the protection of agreed-upon confidential information
and information claimed as confidential where a notification is
withdrawn. | 21(3),(5) | |
17. | Ensure that confidential information is not used for commercial
purposes without the written consent of the notifier. | 21(4) | |
18. | Promote and facilitate public awareness, education and
participation concerning the safe transfer, handling and use of
LMOs, taking also into account risks to human health. | 23(1)(a) | |
19. | Endeavour to ensure that public awareness and education
encompass access to information on LMOs identified in accordance
with the Protocol that may be imported. | 23(1)(b) | |
20. | In accordance with relevant domestic laws, consult with the
public in decision making under the Protocol, while respecting
confidential information. | 23(2) | |
21. | Endeavour to inform the public about the means of public access
to the Biosafety Clearing-House. | 23(3) | |
22. | Adopt appropriate measures aimed a preventing and, if
appropriate, penalizing transboundary movements in contravention of
domestic measures to implement the Protocol. | 25(1) | |
23. | Dispose, at its expense, LMOs that have been the subject of an
illegal transboundary movement through repatriation or destruction,
as appropriate, upon request by an affected Party. | 25(2) | |
III. PROCEDURAL REQUIREMENTS:
ADVANCED INFORMED AGREEMENT
| | Tasks | Article | Check |
1. | Notify, or require the exporter to ensure notification to, in
writing, the competent national authority of the Party of import
prior to the intentional transboundary movement of a living
modified organism that falls within the scope of Article 7,
paragraph 1 | 8(1) | |
2. | Provide written acknowledgement of receipt of notification to
notifier within 90 days, including: | | |
| | - Date of receipt of notification; | 9(2)(a) | |
| | o) - Whether notification meets requirements of annex I; | 9(2)(b) | |
| | - That the import may proceed only with written consent and
whether to proceed in accordance with the domestic regulatory
framework or in accordance with Article 10; OR - Whether the import may proceed after 90 days without further
written consent. | 10(2)(a), 9(2)(c) 10(2)(b) | |
3. | Communicate in writing to the notifier, within 270 days of
receipt of notification: - Approval of the import, with or without conditions; - Prohibition of the import; - A request for additional relevant information in accordance
with domestic regulatory framework or Annex I; or - Extension of the 270 day period by a defined period of time;
AND | 10(3)(a)-(d) | |
| | Except where approval is unconditional, the reasons for the
decision, including the reasons for the request for additional
information or for an extension of time. | 10(4) | |
4. | Provide in writing to the Biosafety Clearing-House the decision
communicated to the notifier. | 10(3) | |
5. | Respond in writing within 90 days to a request by an Exporting
Party for a review of a decision under Article 10 where there has
been a change in circumstances or additional relevant scientific or
technical information has been made available, providing the
reasons for the decision upon review. | 12(2), (3) | |
IV. PROCEDURAL REQUIREMENTS: LIVING MODIFIED ORGANISMS
FOR DIRECT USE AS FOOD, FEED OR FOR
PROCESSING
| | Tasks | Article | Check |
1. | Upon making a final decision regarding domestic use, including
placing on the market, of LMOs that may be subject to transboundary
movement for direct use as food or feed, or for processing, inform
the Biosafety Clearing-House within 15 days of making that
decision, including the information listed in Annex II. | 11(1) | |
2. | Except in the case of field trials, provide hard copies of the
final decision to the National Focal Point of Parties that have
notified the Secretariat in advance that they do not have access to
the Biosafety Clearing-House. | 11(1) | |
3. | Provide additional information contained in paragraph (b) of
annex II about the decision to any Party that requests it. | 11(3) | |
4. | In response to the posting of a decision by another Party, a
Party that decides to import may take a decision on the import of
LMOs-FFP: - either as approved under the domestic regulatory framework
consistent with the Protocol; OR - in the absence of a regulatory framework, on the basis of a
risk assessment in accordance with Annex III within no more than
270 days. In this case, a declaration must be made to the Biosafety
Clearing-House. | 11(4), (6) | |
Annex IV
COORDINATION MECHANISM FOR
THE IMPLEMENTATION OF THE ACTION PLAN ON BUILDING CAPACITIES FOR
THE EFFECTIVE IMPLEMENTATION OF THE CARTAGENA PROTOCOL ON
BIOSAFETY
A. Objective
1. The overall goal of Coordination Mechanism is to facilitate
exchange of information with a view to promoting partnerships and
maximizing complementarities and synergies between various
capacity-building initiatives being undertaken in support of the
Action Plan for Building Capacities for the Effective
Implementation of the Cartagena Protocol on Biosafety.
B. Guiding Principles
2. The implementation of the Coordination Mechanism is guided by
the following basic principles:
(a) It serves to facilitate the sharing of information regarding
capacity-building activities implemented in support of the Action
Plan. It is not as mechanism for controlling, supervising or
evaluating different initiatives;
(b) Participation in, and exchange of information through the
Coordination Mechanism is voluntary and open to all interested
stakeholders involved in the implementation of the action plan;
(c) It is a simple, easily accessible and flexible system whose
operation involves minimal additional resource requirements;
(d) It is implemented in a flexible, gradual, phased and
incremental manner. Improvements made as experience is gained over
time;
(e) It complements and adds value to existing relevant
coordination and networking initiatives, avoiding duplication as
much as possible.
C. Elements of the Coordination
Mechanism
3. The Coordination Mechanism consists of the following five
elements:
(a) Liaison group;
(b) Biosafety capacity-building databases;
(c) Information-sharing and networking mechanism;
(d) Coordination meetings and workshops;
(e) Reporting mechanisms.
1. Liaison group on
capacity-building for biosafety
Nature and structure
4. The liaison group is a small ad hoc group,
ratherthan a standing body, established
by the Executive Secretary to address specific capacity-building
issues/topics, as need arises. Participants serve in their
individual capacity and not as representatives of their Governments
or organizations. They are selected on the basis of their
demonstrated expertise and experience with regard to the issue(s)
to be addressed, a balanced geographical distribution between
regions, and a fair representation of relevant stakeholders. Every
effort is made to ensure any one meeting of the group includes some
of the participants that attended the previous meetings in order to
maintain some degree of consistency and institutional memory.
Role
5. The overall mandate of the liaison group is to provide expert
advice to the Executive Secretary on ways and means to enhance the
coordination and effective implementation of the Action Plan for
Building Capacities for the Effective Implementation of the
Cartagena Protocol on Biosafety. Among other tasks, it exchanges
ideas and provides advice on overall strategic approaches as well
as conceptual and possible practical operational measures for
enhancing coordination of the capacity-building initiatives.
Operational modalities
6. The liaison group is established in accordance with the
existing practice under the Convention on Biological Diversity,
including guidance under decision IV/16, annex I and SBSTTA
recommendation V/14. To the extent possible the liaison group
undertakes its work using electronic communication means, including
e-mail and teleconferences moderated by the elected chairperson
with the technical support of the Secretariat. Face-to-face
meetings of the Group are usually organized, subject to
availability of resources, back-to-back with other meetings where
most members of the Group are to be present. The Secretariat
endeavours to obtain funding to facilitate the participation of
representatives of developing countries and countries with
economies in transition in the meetings of the Group.
2. Biosafety
capacity-buildingdatabases
Nature and structure
7. This element comprises databases on capacity-building
activities, such as projects and capacity-building opportunities,
as well as country capacity-needs, which are maintained and
accessed through the Biosafety Clearing-House. The projects
database includes initiatives that have a series of inter-linked
activities implemented as integral components over a long period of
time (at least over six months). Each record includes information
on: the project location, funding details, objectives and
activities, main outcomes, lessons learned and a brief background.
On the other hand, the capacity-building opportunities database
includes punctual/standalone activities (e.g. funding grants,
training courses, scholarships or internships) that are not part of
a larger project included in the projects database. Each record
includes: the type of opportunity, its scope, timeframe,
eligibility criteria, application process and contacts. Finally,
the capacity-needs database includes submissions by countries of
their prioritized needs, the desired means to address needs
identified and an outline of measures being taken. Records in all
the databases contain summary information about the project,
opportunity or country needs and provide contacts or web links
where further information can be obtained.
Role
8. The overall function of the databases is to provide a central
point where up-to-date information, or sources of information,
about biosafety capacity-building projects, opportunities and
country needs are registered and accessed easily and in a timely
manner. The databases play a "clearing-house" role where countries
requiring assistance and those providing assistance interact, thus
facilitating systematic tailoring of available assistance towards
specific country-defined priority needs and promoting partnerships
between seekers and providers of support. The databases also
facilitate identification of opportunities for promoting synergies,
collaboration and partnerships. The projects database in particular
facilitates sharing of information about the coverage,
achievements, experiences, best-practices and lessons learned under
different projects. It also facilitates the identification gaps and
minimization of unnecessary overlaps or duplication of efforts and
resources.
Operational modalities
9. The capacity-building databases are managed and accessed
through the Biosafety Clearing-House. Common formats are used to
assist all countries and organizations to submit information in a
consistent manner and facilitate customized searching of the
databases. Relevant information can be registered in the databases
either online or by hardcopy. Under the first option, persons
designated by Government or relevant organizations can register
information directly into the database through the management
centre using a password system. Those without Internet access can
fill and return to the Secretariat hard copies of the common
formats for incorporation in the databases. The databases are
maintained by the Secretariat, which periodically reminds owners of
the records in the database to update them as appropriate.
3. Information-sharing and
networking mechanism
10. This element consists of two components namely: (a)
biosafety information resource centre; and (b) biosafety
capacity-building network.
(a) Biosafety information resource
centre
Nature and structure
11. The biosafety information resource centre is a "virtual
library" consisting of catalogues of information, scientific data
and resource materials relevant to biosafety capacity-building
produced by various organizations and Governments. These may
include: training materials, course catalogues, operational
toolkits or guidelines, workshop reports, paper and presentations,
case-studies, technical publications, newsletters and journals,
legal documents, project profiles, project proposal preparation
materials and others in form of publications, CD-ROMs or other
media. Records are based on common format with the following key
fields: title of the record, type of information (e.g. manual,
case-study, or workshop report), thematic areas (based on the
Action Plan elements), author, date of publication, name of
publisher or organization, key words as well as an abstract or a
book review. Each record includes contact details
and/orlinks to the relevant websites or
databases where detailed information could be obtained are
provided.
Role
12. The biosafety information resource centre provides a central
gateway to relevant biosafety information, scientific data and
resource materials available at different sources with the view to
ensuring their broader dissemination, easy and timely access, and
their maximum use. In addition, it helps those planning to produce
new materials to avoid duplicating what is already available and
focus on areas not yet addressed or "adding-value" to existing
materials.
Operational modalities
13. The biosafety information resource centre is maintained in
the Biosafety Clearing-House and linked to the document search
facility ofthe Convention on Biological
Diversity. Governments and organizations are invited to register
their relevant information and resource materials using a common
format or provide copies to the Secretariat for entry in the
information resource centre. Records are searchable, through an
electronic catalogue, by type of information, thematic area,
author, and date of publication or by the publisher or owner of the
information. In addition, a full text search using keywords is
possible. Where possible hard copies or CD-ROMs of uncopyrighted
materials are made available to countries without Internet access,
upon request. Users of materials from the resource centre are
encouraged to indicate their specific information needs and provide
feedback on their experiences in using the resource centre in order
to facilitate ongoing improvement of the system.
(b) Biosafety capacity-building
network
Nature and structure
14. The biosafety capacity-building network is a platform that
links key different individuals from Government agencies, research
institutions and other relevant organizations who are interested in
or involved in designing, implementing or funding biosafety
capacity-building and research activities, to interact and exchange
views, knowledge and experiences, informally. It complements other
existing relevant networks such as the Inter-Agency Network for
Safety in Biotechnology (IANB) coordinated by the Organisation for
Economic Co-operation and Development (OECD).
Role
15. The primary role of the biosafety capacity-building network
is to facilitate active interaction and sharing of knowledge,
views, experiences and lessons learned among individuals,
organizations and donor agencies interested in promoting biosafety
capacity-building and sharing scientific knowledge, in a timely,
organized and effective manner. It seeks to foster contacts and
strengthen existing linkages between different organizations in
order to leverage expertise and promote synergies, partnerships and
mutual support as well as dialogue and consensus around key issues,
including adoption common concepts and approaches. It also enables
scientific experts to share biosafety research results and to
exchange professional viewpoints on specific issues. It also
provides a forum for interested scientists to discuss and build
consensus around specific technical and scientific issues related
to biosafety.
Operational modalities
16. The biosafety capacity-building network is administered
through the Biosafety Clearing-House, which serves as the "network
hub". It operates primarily using Internet-based tools, including
e-mail listservs, bulletin boards, electronic discussion forums and
electronic conferences. Prospective members of the network can
register with the Secretariat through the Biosafety Clearing-House
and be issued with a password to enable them access and participate
in the relevant e-discussions, in accordance with the established
rules and procedures. Network members are encouraged to volunteer
information and to take lead in organizing and moderating specific
thematic discussions, in collaboration with the Secretariat. The
discussions may result in specific outputs (e.g. proceedings) that
could be published and made available to all countries, as
appropriate or lead to consensus around particular issues (e.g.
agreed terminologies or approaches).
4. Coordination meetings and
workshops
Nature and structure
17. Coordination meetings provide a forum where individuals from
relevant organizations, Government agencies and donors involved in
designing, implementing or funding biosafety capacity-building
activities meet face-to-face, in an informal setting, to exchange
information, knowledge and lessons regarding their
capacity-building efforts. They may be in the form of roundtables,
workshops orinformal consultations. The
meetings are informal, flexible and not too structured in order to
allow free exchange of information and ideas.
Role
18. The primary goal of the coordination meetings is to
facilitate the sharing of knowledge, views and operational
experience between different organizations regarding their
biosafety capacity-building activities, with the view to fostering
synergies, partnerships and harmonization of efforts. In
particular, the meetings help relevant organizations to develop a
common understanding of the major biosafety capacity-building
issues, challenges and priority needs of countries. They also
provide a means to review the coverage, gaps and overlap in ongoing
activities and to identify possible solutions to address the gaps,
minimize overlaps and avoid over-coverage of certain issues or
geographic areas at the expense of others. Finally, the meetings
facilitate exchange of innovative ideas to improve the delivery of
capacity-building assistance to countries and to promote strategic
and systematic efforts, tailored to specific country-defined needs
and priorities in order to realize maximum impact.
Operational modalities
19. Coordination meetings are organized by the Secretariat, in
collaboration with interested organizations, subject to
availability of funding. Wherever possible, they are organized on
the margins of other major events where most of the relevant
organizations are present, in order to optimize participation. The
agenda and duration of the meetings is determined by the
co-organizer(s). The meetings do not necessarily follow a regular
schedule but are adaptive and take advantage of strategic events.
Prior to each meeting, participants are encouraged to submit to the
organizers relevant information including updates on their on-going
activities, to be shared with other participants.
5. Reporting mechanism
Nature and structure
20. The reporting mechanism is a central system comprising a
database of reports and/or web links to reports related to
capacity-building in biosafety which are produced by Governments
and relevant organizations. These include progress reports on
implementation of the Action Plan as requested by the Conference of
the Parties serving as the meeting of the Parties to the Protocol
as well as voluntary reports from relevant organizations, such as
project progress reports or end-of-cycle evaluation reports,
project appraisal reports or mission reports as well as
case-studies on success stories covering experiences,
accomplishments and lessons learned.
Role
21. The reporting mechanism provides a central point where
relevant reports or case-studies of success stories of initiatives
relevant to capacity-building in biosafety can be deposited,
accessed and shared. The primary purpose is to make such
information easily and widely accessible in order to enable Parties
and relevant organizations to draw upon each other's experiences
and accomplishments to enhance the implementation of the
capacity-building Action Plan. Sharing of such reports is a key
ingredient in promoting synergies, collaborative partnerships and
mutual learning. In particular, the mechanism has the following
functions: assist in developing an overall picture of the progress
made in capacity-building; showcase success stories and factors and
facilitate their replication, facilitate identification and
promotion of positive best-practices and avoidance of pitfalls or
"re-invention of the wheel".
Operational modalities
22. A database of biosafety capacity-building reports is
maintainedin the Biosafety Clearing-House
where Parties, Governments and relevant organizations submit and
access the available reports using a common format. Wherever
possible, links are made to existing national, regional or
organizational databases, websites and other contacts where such
reports can be accessed in order to minimize the need for countries
and organizations to provide the same information to more than one
place. The reports are organized in a searchable format with a
number of fields including: type of report, timeframe,
organization, thematic areas and key words (for example to
facilitate search for best-practices and lessons learned).
C. Administration of the
Coordination Mechanism
23. The Coordination Mechanism is administered by the
ExecutiveSecretary, whose primary
functions include the following:
(a) Maintaining the capacity-building databases (on projects,
opportunities and country needs), including their regular updating
based on submissions received from the participating Parties,
Governments, relevant organizations and donors;
(b) Facilitating the dissemination of relevant information and
lessons learned on biosafety capacity-building initiatives through
the Biosafety Clearing-House and information documents to the
Conference of the Parties serving as the meeting of the Parties to
the Protocol;
(c) Preparing and disseminating synthesis reports based on the
submissions by Parties, Governments and relevant organizations on
their progress in implementing various elements of the Action Plan,
using a common format;
(d) Convening and servicing meetings of the liaison group on
capacity-building on biosafety, as necessary;
(e) Organizing, subject to availability of funding, periodic
coordination meetings and workshops for Government representatives,
relevant organizations and donors, in collaboration with the Global
Environment Facility (GEF) and its Implementing Agencies and other
relevant organizations;
(f) Promoting broad and common understanding of the
capacity-building needs for the effective implementation of the
Protocol.
Annex V
SET OF INDICATORS FOR
MONITORING IMPLEMENTATION OF THE ACTION PLAN FOR BUILDING
CAPACITIES FOR THE EFFECTIVE IMPLEMENTATION OF THE
PROTOCOL
1. The set of indicators presented below is intended for use in
tracking the overall progress in implementing the Action Plan,
encompassing the overall cumulative contribution of different
capacity-building projects and other activities. The indicators are
not intended for use in measuring the results of specific
individual capacity-building projects. Such indicators would need
to be developed on a case-specific basis.
2. In the set of indicators outlined below, four main types can
be identified, namely: "indicators of existence", "indicators of
status", "indicators of change"
and"indicators of progress towards an
endpoint". The first type includes indicators that show whether
something exists or not (i.e. yes/no), e.g. existence of laws and
regulations. Status indicators include actual values/ levels of a
given parameter, either quantitatively (e.g. number of people,
percentage of people) or qualitatively (e.g., low/medium/high). The
"indicators of change" show variation in the level of a given
parameter, either increase/decrease or positive/negative.
Indicators of change are measured in comparison to a starting point
in time or in terms of progress towards and endpoint. In some
cases, the measurement may be quantitative (e.g. change in number
of staff), and in other cases it may be qualitative (e.g. change in
level of satisfaction). They may also show overall trends or
pattern of change.
Desired outcome (based on Action Plan
elements) | Criteria and
indicators |
A. Improved institutional capacity | |
(i)Effective legislative and policy frameworks in
place | 1. a) Existence of biosafety frameworks (e.g. policies, laws and
regulations) b) Level of harmonization of national biosafety frameworks with
other national policy frameworks and programmes c) Level of consistency of national biosafety frameworks with
the Protocol d) Level of stakeholder satisfaction with the national biosafety
frameworks |
(ii) Appropriate administrative frameworks in
place | 1. a) Existence of clearly defined institutional mechanisms for
administering biosafety, including designation of competent
national authorities and responsibilities among agencies b) Change in the quantity and quality of staffing in national
institutions dealing with biosafety c) Percentage of notifications handled and decisions taken
within the timeframes specified in the Protocol d) Existence of systems for managing biosafety records and for
maintaining institutional memory e) Existence of mechanisms for inter-institutional coordination
(e.g. steering committees or intranets), and change in the level of
activity of such mechanisms |
(iii) Improved technical, scientific, and
telecommunications infrastructures | 1. a) Change in the quantity and reliability of office equipment
and facilities in institutions dealing with biosafety b) Number and variety of facilities (e.g. laboratories)
available for biosafety research work c) Change in the level of reliability of telecommunication
infrastructure |
(iv) Enhanced funding and resource
management | 1. a) Amount of funding for biosafety activities received or
provided b) Percentage of funding for biosafety coming from national
budgetary allocation c) Rate at which resources earmarked for biosafety are used for
the intended activities and in a cost-effective manner |
(v) Enhanced mechanisms for follow-up, monitoring
and assessment | 1. a) Existence of national mechanisms for monitoring and
reporting of implementation of the Protocol |
B. Improved human resources capacity development and
training | 1. a) Number of national experts trained in diverse specialized
biosafety-related fields b) Frequency at which local experts are used in undertaking or
reviewing risk assessments and other activities relating to the
implementation of the Protocol c) Frequency at which expertise from the roster of experts is
accessible whenever required by countries |
C. Improved capacity for risk assessment and other
scientific and technical expertise | 1. a) Amount of biosafety research and proportion of risk
assessments carried out locally b) Frequency at which local expertise is used in undertaking or
reviewing risk assessments |
D. Improved capacity in risk
management | 1. a) Existence of risk management strategies for LMOs with
identified risks b) Rate at which risk management strategies and measures
developed to prevent or mitigate identified risks are actually
implemented |
E. Improved public awareness, participation and
education in biosafety at all levels | 1. a) Change in level of public awareness of the Protocol b) Change in the number, scope and variety of measures taken to
promote awareness of the biosafety and the Protocol c) Rate of involvement of relevant stakeholders in
decision-making and in the development and implementation of
national biodiversity frameworks d) Change in frequency of public access to relevant biosafety
information, including through the Biosafety Clearing-House |
F. Improved information exchange and data management
including full participation in the Biosafety
Clearing-House | 1. a) Change in level of exchange of relevant biosafety data and
information b) Extent to which information required under the Protocol is
provided to the Biosafety Clearing-House c) Existence of national systems for data management and
information exchange d) Existence of appropriate national infrastructure and
capability to access the Biosafety Clearing-House e) Degree to which the Biosafety Clearing-House responds to the
information needs of different stakeholders f) Level of stakeholder satisfaction with the Biosafety
Clearing-House (including its accessibility, user-friendliness and
content) g) Change in number, frequency and regional distribution of
Governments and organizations accessing and retrieving information
from the Biosafety Clearing-House h) Change in number and regional distribution of Governments and
organizations contributing information to the Biosafety
Clearing-House |
Desired outcome (based on Action Plan
elements) | Criteria and
indicators |
G. Increased scientific, technical and institutional
collaboration at sub regional, regional and international
levels | 1. a) Existence of various mechanisms for regional and
international collaboration in biosafety b) Change in number of bilateral and multilateral collaborative
initiatives in biosafety underway c) Change in level of participation in regional and
international collaborative mechanisms and initiatives d) Existence of, and level of participation in, regional/
sub-regional advisory mechanisms and centers of excellence e) Existence of regional and sub-regional websites and
databases f) Existence of mechanisms for regional and sub-regional
coordination and harmonization of biosafety regulatory
frameworks g) Existence of, and level of participation in, mechanisms for
promoting south-south cooperation in biosafety issues h) Change in amount and availability of international technical
guidance for implementation of the Protocol i) Existence of mechanisms for promoting common approaches |
H. Improved access to and transfer of technology and
know-how | 1. a) Existence of enabling frameworks for technology
transfer b) Change in number of relevant technologies transferred |
I. Improved identification of LMO shipments as
required by the Protocol | 1. a) Existence of national measures for identification of LMO
shipments b) Change in level of use of modern LMO identification
techniques c) Change in level of effectiveness of identification systems
and measures in ensuring safe handling, transport and packaging of
LMOs |
