ICCP 3 Recommendation III/5

Capacity-building (Article 22 and Article 28, paragraph 3)

The Intergovernmental Committee for the Cartagena Protocol on Biosafety,

Recalling its recommendation 2/9 A adopted at its second meeting,

Recognizing the critical need to build the capacity of developing countries, in particular the least developed and the small island developing States among them, and Parties with economies in transition, to enable them access the Biosafety Clearing-House and to ratify and implement the Cartagena Protocol on Biosafety,

Welcoming the initial gap analysis by the Executive Secretary of the capacity-building initiatives as an important step in identifying areas where further efforts would be needed,

Recognizing the roles played by different entities in supporting capacity-building for biosafety;

Stressing the need for coordination between various capacity-building efforts and funding initiatives at all levels to maximize complementarities and synergies, and promote partnerships,

Noting the varying requirements of countries and the need for capacity-building initiatives to be demand-driven,

1. Welcomes the decision of the Conference of the Parties at its sixth meeting, 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;

2. Recommends that the Conference of the Parties serving as the meeting of the Parties to the Protocol 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 I to the present recommendation;

3. Invites developed country Parties and other donors to make voluntary financial contributions to the Secretariat to facilitate implementation of the Coordination Mechanism;

4. Urges Parties, Governments and relevant organizations to register information on their biosafety capacity-building initiatives in the Biosafety Clearing-House, including reports on the achievements, lessons learned and opportunities for cooperation;

5. Invites Parties, Governments and relevant organizations to address the gaps in implementation of the priority elements of the Action Plan and the geographic coverage of the capacity-building initiatives identified by the Executive Secretary, taking into account the indicative list of the roles of different entities in supporting capacity-building contained in annex II to the present recommendation;

6 Requests developed country Parties, donors and relevant organisations to provide assistance to developing countries, in particular the least developed and the small island developing States among them, and Parties with economies in transition, to organize workshops on capacity-building;

7. Encourages Parties, Governments and organizations to use, as appropriate, the relevant implementation tool kit contained in annex III to the present recommendation;

8. 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;

9. Takes note of the preliminary set of indicators for monitoring implementation of the Action Plan, contained in annex IV to this recommendation; invites Parties, Governments, and relevant organizations to submit their views and comments to the Executive Secretary no later than three months prior to the first meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol; and requests the Executive Secretary to prepare, on the basis of these submissions, a revised set of indicators for consideration by that meeting;

10. Requests the Executive Secretary to discharge the functions, within existing resources, specified in annex I to the present recommendation, in collaboration with other relevant agencies, with a view to operationalizing the Coordination Mechanism.

Annex I

COORDINATION MECHANISM FOR THE IMPLEMENTATION OF THE ACTION PLAN ON BUILDING CAPACITIES FOR THE EFFECTIVE IMPLEMENTATION OF THE CARTAGENA PROTOCOL ON BIOSAFETY

A. Objective

The overall goal of Coordination Mechanism is to facilitate exchange of information with a view to promoting partnerships and to maximize complementarities and synergies between various capacity building initiatives being undertaken in support of the Action Plan for Capacity Building for the Effective Implementation of the Cartagena Protocol on Biosafety.

B. Elements

The coordination mechanism for the implementation of the Action Plan consists of the following elements:

1. A regionally-balanced liaison group on capacity building for biosafety:

This shall be established by the Executive Secretary to provide expert advice to the Secretariat and the Intergovernmental Committee for the Cartagena Protocol on Biosafety/Conference of the Parties serving as the meeting of the Parties on ways and means to enhance the coordination and effective implementation of the Action Plan.

2. The biosafety capacity-building projects database:

The projects database currently maintained by the Secretariat on the Biosafety Clearing-House shall be strengthened and kept up-to-date to facilitate coordination and exchange of information, and also to serve as a tool for identifying the coverage, overlaps and gaps in the capacity-building activities and funding by different organizations.

3. An information sharing and networking mechanism:

An information sharing mechanism (including, an e-mail list-server) shall be established to facilitate regular and timely exchange of information and lessons learned between individuals in different countries, relevant organizations and donor agencies involved in promoting biosafety capacity-building. In addition, the Secretariat shall collaborate with the ad-hoc Inter-Agency Network for Safety in Biotechnology (IANB), coordinated by the Organisation for Economic Co-operation and Development, in promoting regular interaction and networking.

4. Coordination meetings and workshops:

Periodic coordination meetings, workshops or roundtables for government representatives, relevant organizations and donors agencies shall be organized on a regular basis, to promote dialogue, identify and promote synergies, encourage partnerships, address emerging common issues, promote greater understanding of evolving capacity needs of countries and encourage mutually supportive strategies across organizations involved in capacity-building for biosafety.

5. Reporting mechanism:

A central reporting mechanism, using existing databases, for major capacity-building projects and other initiatives using a uniform format, for example, a central portal or database linked to relevant national, regional or institutional nodes/ databases, shall be established to facilitate the identification of the coverage, progress and impact made, and major gaps, on the basis of the information received. The projects database maintained under the Biosafety Clearing-House shall be expanded and resourced to play this role.

C. Administration of the Coordination Mechanism

The Secretariat of the Convention on Biological Diversity and the Protocol shall administer the Coordination Mechanism. These functions of the Secretariat, as the administrator of the Mechanism shall, in pursuit of the above goal, include the following:

1. Maintain the capacity-building project database, including its regular updating based on submissions received from the participating Parties, Governments, relevant organizations and donors;

2. Develop and maintain in the Biosafety Clearing-House a page where countries can access information readily on available capacity-building support and those requiring support could indicate their specific capacity-building needs.

3. Facilitate 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;

4. Prepare and disseminate synthesis of 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;

5. Convene and service meetings of the liaison group on capacity building on biosafety, as necessary;

6. Organize, subject to availability of funding, periodic coordination meetings and workshops for government representatives, relevant organizations and donors, in collaboration with GEF, UNEP and other relevant organizations;

7. Promote broad and common understanding of the capacity-building needs for the effective implementation of the Protocol.

Annex II

THE ROLE OF DIFFERENT ENTITIES IN SUPPORTING CAPACITY-BUILDING 3/

1. The present annex summarizes, in a point-by-point list form, the views of Parties and governments regarding the roles which different entities could play to facilitate capacity-building to assist countries in preparing for the entry into force of the Protocol received by the Secretariat in response to a questionnaire that was sent to all national focal points together with the notification of 12 January 2001. The countries and regional economic integration organizations that specifically addressed this issue in their responses to the questionnaire were: Argentina, Costa Rica, Cuba, Ecuador, the European Union, India, Jamaica, Japan, Switzerland, Turkey, United States of America and Uruguay.

2. The role of the ICCP:

(a) Assuming the overall responsibility for decisions regarding the establishment of the work programme related to capacity-building and evaluation of its implementation (as illustrated in document UNEP/CBD/ICCP/1/9);

(b) Setting norms for harmonization;

(c) Developing common 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 required for the first meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol to decide what capacity-building projects will 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:

(a) Providing an administrative framework for creation of technical and scientific capacity;

(b) Implementing the pilot phase of the Biosafety Clearing-House, taking account of priority needs regarding the capacities of Governments for access to the Biosafety Clearing-House and the views of Governments on monitoring progress;

(c) Administering the Biosafety Clearing-House;

(d) Undertaking further synthesis and analysis of the identified needs of countries for implementation of the Protocol, and available means for assistance and information exchange;

(e) 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;

(f) Facilitating the flow of information;

(g) Promoting synergies and keeping countries abreast of important developments and opportunities with respect to capacity-building - e.g., roster of experts;

(h) Facilitating the functioning of the roster of experts;

(i) Implementing the relevant recommendation of ICCP and later the decisions of the Conference of the Parties serving as the meeting of the Parties;

(j) Cooperating with the UNEP/GEF enabling project on national biosafety frameworks;

(k) Facilitating and promoting collaboration and coordination among existing initiatives on capacity-building; and

(l) Providing coordination and leadership and suggesting ways and means to build capacity in countries, taking into account the recommendations of the ICCP.

4. Subject to the decisions of the Conference of the Parties, the role of the Global Environment Facility (GEF) includes:

(a) Providing funds necessary to build legislative and administrative frameworks, and for training in risk assessment and risk management;

(b) Deciding on further areas for financial support for capacity-building in accordance with the identified priority needs of developing countries, including results of the first meeting of the ICCP, responses to the questionnaire, the outcomes of inter-sessional workshops, and its previous pilot project on biosafety;

(c) Implementing the GEF Initial Strategy adopted by the GEF Council in November 2000 to assist countries prepare for the entry into force of the Cartagena Protocol;

(d) Facilitating the provision of technical support; and

(e) Facilitating the use of existing and developing regional networks.

5. The role of other bilateral and multilateral donors:

(a) Providing funding 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 sub-regional 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:

(a) Assisting national authorities of Parties to take decisions;

(b) Sharing "best practices", models and information pertinent to relations between obligations under trade agreements and obligations under the Protocol;

(c) 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;

(d) Contributing to implementation of the project on Development of National Biosafety Frameworks, in line with the terms agreed by the GEF Council and relevant decisions taken at the first meeting of the ICCP;

(e) Providing access to databases containing 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);

(f) 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;

(g) Ensuring coordination and mutual supportiveness with other bodies and conventions concerned with LMO issues: e.g., 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;

(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

(i) Providing co-financing for capacity-building activities.

7. The role of regional networks:

(a) Promoting harmonization of technical, legal and scientific mechanisms in the countries;

(b) Identifying and disseminating information related to best practice 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:

(a) Cooperating in consensus-building and assisting in raising public education and awareness;

(b) Participating in and assisting in national and regional efforts to implement the Protocol, including helping to implement the Biosafety Clearing-House;

(c) Contributing to guidance on Protocol implementation issues;

(d) 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;

(e) Representing specialist or sectoral interests in relation to risk assessment and risk management issues;

(f) Reinforcing collaboration among capacity-building projects on biotechnology and biosafety in order to avoid duplication and to efficiently use the limited resources available;

(g) Associating with capacity-building initiatives, ensuring public participation and promoting public awareness on biosafety issues; and

(h) Providing co-financing for capacity-building activities.

9. The role of private sector/industry:

(a) Participating in the effective implementation of the Protocol, including creation of awareness and provision of technical advice;

(b) Creating confidence with consumers;

(c) Developing techniques for identification, detection and analytical assessment and for monitoring;

(d) Developing systems for labeling, traceability and unique identifier;

(e) Improving capabilities of accessing and handling electronic information;

(f) Providing scholarships in the areas mentioned above;

(g) Undertaking risk assessment, and addressing information needs and concerns of industry;

(h) Associating with initiatives on capacity-building and sharing experience with risk assessment and management of LMOs; and

(i) Providing co-financing for capacity-building activities.

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 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 GMOs 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.

Annex III

IMPLEMENTATION TOOL KIT 4/

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:

B7 Administrative tasks (initial and future)

B7 Legal requirements and/or undertakings

B7 Procedural requirements (AIA and Article 11)

I. ADMINISTRATIVE TASKS

 

Tasks

Article

_

 

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 LMO-FFPs; 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

_

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 LMO-FFPs.

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.

Endeavor 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 LMO-FFPs

- 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.

Endeavor 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.

Endeavor 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

_

1.

Provide written acknowledgement of receipt of notification to notifier within 90 days, including:

   
 

- Date of receipt of notification;

9(2)(a)

 
 

- 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)

 

2.

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)

 

3.

Provide in writing to the Biosafety Clearing-House the decision communicated to the notifier.

10(3)

 

4.

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

_

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 LMO-FFPs:

- 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

A PRELIMINARY SET OF INDICATORS FOR THE ACTION PLAN TO BUILD CAPACITIES FOR THE EFFECTIVE IMPLEMENTATION OF THE CARTAGENA PROTOCOL ON BIOSAFETY

Key Capacity Building Element

Input/Output Indicators

(related to extent to which activities and processes have been implemented and the outputs produced)

Indicators of results

(related to the overall positive changes/ improvement in implementing the Protocol).

Indicators of Impact

(related to overall contribution to the realization of the Protocol's objectives)

1. Institutional capacity-building

     

a) Legislative and policy frameworks

B7 Number of countries that have ratified the Protocol

B7 Number of countries that have developed biosafety national biosafety frameworks - NBFs (including biosafety strategies, laws, regulations and guidelines)

B7 Level of clarity and comprehensiveness of the biosafety policies, legislation and guidelines developed

B7 Level of stakeholder involvement in the development of NBFs

B7 Existence of enforcement measures, standards and compliance mechanisms

B7 Level of effectiveness in implementing/ enforcing biosafety agreements, laws, regulations and guidelines

B7 Majority of countries are Parties to the Protocol

B7 Existence of National biosafety frameworks in all countries

B7 Biosafety regulations effectively being implemented in a participatory manner

B7 Improved implementation/ enforcement of biosafety laws and regulation

B7 Increased levels of adherence to the biosafety guidelines by importers, researchers or users of LMOs.

B7 Better biosafety policies in place in most countries

B7 Parties and governments complying effectively with the provisions of the Protocol.

B7 Fewer incidences of illegal transboundary movement, handling and use of LMOs with adverse effects on biodiversity and human health.

B7 Fewer or no cases of non-compliance.

b) Administrative Framework

B7 Number of countries with national institutional mechanisms (e.g. biosafety units, steering committees or advisory groups), with clear mandates, established to oversee biosafety

B7 Number of national research and regulatory bodies with biosafety liaison offices/ committees at the institutional level

B7 Level of clarity, and harmonisation, of institutional responsibilities for various national bodies dealing with biosafety

B7 Level and quality of collaboration between different national institutions and processes

B7 Level of coherence and effectiveness of the administrative processes and procedures, including approval of permits, acknowledgement of notification, review period, etc.

B7 Existence of monitoring and enforcement mechanisms

B7 Level of efficiency in administering the Advance Informed Agreement (AIA) procedure

B7 Level of efficiency in decision-making

B7 Increased level of effectiveness and efficiency in administering the AIA procedure.

B7 Improvements in administrative procedures and pragmatic delivery of services (faster and efficient).

B7 Existence of fully staffed National Biosafety Agencies, Division or Units and functional National Biosafety Committees in all countries by COP-MOP.2

B7 Increased efficiency in decision-making

B7 Improved quality of decisions on notifications and in cases of emergencies

B7 Streamlined and efficient administration of the AIA procedure motivating exporters to avoid illegal transactions, thus facilitating safer transboundary movement of LMOs.

B7 Efficient decision-making systems and procedures leading to reduced non-compliance.

c) Infrastructure

B7 Existence of adequate infrastructure - office facilities, services and communications systems

B7 Existence of necessary equipment and supplies, computers and transportation to support and facilitate daily work of individuals and institutions

B7 Number of research laboratories and field stations established/ strengthened

B7 Existence of border control and inspection facilities

B7 Availability of adequate office facilities, equipment and supplies for biosafety work

B7 Improvement in the number and quality of research facilities (including well equipped laboratories, field stations, etc).

B7 Well equipped institutions effectively regulating the import and use of LMOs thus minimizing potential adverse effects of LMOs on biodiversity and human health

d) Funding

B7 Levels of total funding for biosafety, both national budgetary allocations and international contributions

B7 Growth rate in expenditures on biosafety research and regulation

B7 Percentage of expenditure (investment) on biosafety in relation to the overall annual government budget

B7 Ratio of the total funding for biosafety work provided by the public sector to that provided by the private commercial sector

B7 Relative ratio of expenditures on capital: personnel: operating costs: research costs

B7 Level of mobilization and leverage of funds from different sources

B7 Levels of sustainability of funding for biosafety

B7 Increased budgetary allocations for biosafety activities

B7 Improved and timely release of funds

B7 Increased availability and sustainability of financial resources for biosafety activities

B7 Existence of diverse and secure source of funding for biosafety.

Availability of adequate, sustainable and easily accessible funding enabling timely implementation of biosafety measures thus increasing levels of preparedness and effectiveness in minimizing chances of adverse effects of LMOs on biodiversity and human health due to lack of preventative and timely action.

e) Monitoring and Assessment mechanism

B7 Number of countries that have established monitoring and enforcement mechanisms

B7 Number of countries with mechanisms for border control and inspection of LMOs

B7 Reduced number of cases of illegal importation and use of LMOs.

B7 Improved consumer confidence.

B7 Lower risk of adverse effects on biodiversity and human health due to illegal importation of LMOs

2. Human Resources Development and Training

B7 Number of biosafety training events (courses, seminars, internships, fellowships and study tours) organized

B7 Number of institutions providing specialized in key biosafety areas

B7 Number of experts trained at BSc., MSc. and PhD degree levels in different fields relevant to biosafety

B7 Number of professional staff (administrators, policy makers, regulators, legislators, scientists) and technicians (e.g. laboratory technicians, biometricians, etc) appropriately deployed to work on biosafety issues

B7 Number of experts registered in the rosters of experts at various levels

B7 The ratio of technical staff to research staff to managerial staff

B7 Existence of a critical mass of well trained experts in biosafety available in each country or sub-region

B7 More trained staff deployed appropriately and performing effectively

B7 Existence of highly motivated and efficient permanent staff working in biosafety

B7 Lower rates of staff turnover

B7 Reduced demand for the use of experts from the Roster maintained by the Secretariat.

B7 Existence of well trained experts capable of regulating the importation and use of LMOs and conducting reliable risk assessments leading to minimization of potential adverse effects of LMOs on biodiversity and human health.

3. Risk assessment and other scientific and technical expertise

B7 Number of countries that have established and are effectively using risk-assessment frameworks and guidelines

B7 Existence of risk assessment/risk management review processes and mechanisms (e.g. review bodies, directory of scientists) established

B7 Level of effectiveness in reviewing risk assessment reports

B7 Number of risk assessments effectively carried out or reviewed by local experts

B7 Extent to which science based risk assessment methods and techniques are used effectively.

B7 Improved capacity in assessing risks of LMOs

B7 Reduced incidences of 93disguised94 importation of LMOs with potential risks to the biodiversity and human health

B7 Reduced incidences of inappropriate release of inadequately assessed LMOs with potential adverse effects on biodiversity and human health

B7 Minimized risks of adverse effects of LMOs on biodiversity and human health due to effective implementation of reliable, scientifically based risk assessments

4. Risk management

B7 Number of countries with clear risk management strategies and mechanisms

B7 Existence of mechanisms for providing immediate assistance in case of emergencies that may arise from LMOs

B7 Level of effectiveness in implementing risk management strategies.

B7 Improved monitoring and prevention of potential risks to the environment due to deliberate or unintentional release of LMOs

B7 Improved level of preparedness to handle judiciously cases of emergencies that may arise from unintentional release of LMOs

B7 Minimized emergence of unpredicted adverse effects of LMOs on biodiversity and human health due to effective risk management strategies.

5. Awareness, education and participation

B7 Number of organizations involved in promoting awareness on biosafety

B7 Number of awareness workshops, symposia, seminars and other dialogues organized at the national, sub-regional, regional and global levels on biosafety themes

B7 Number of news agencies covering biosafety issues on a regular basis

B7 Average number of news articles related to biosafety appearing in news papers weekly or monthly

B7 Number and volume of awareness materials (posters, brochures, booklets, guidebooks) produced and disseminated to specific target audiences

B7 Number and range of stakeholders participating effectively in national, regional and international biosafety meetings, processes and dialogues

B7 Number of countries that have conducted stakeholder analyses (outlining the interests, strengths and limitations of relevant stakeholders)

B7 Existence of formal stakeholder consultative mechanisms/ forums at various levels.

B7 Increased media coverage of biosafety issues

B7 Policy briefs and fact sheets on emerging biosafety issues being produced and disseminated regularly

B7 Increased public awareness and understanding of the provisions of the Protocol and of the necessary actions.

B7 Increased political support for the Protocol at various levels

B7 Existence of mechanisms for open dialogue in all countries

B7 Increased level of stakeholder participation in biosafety activities/processes

B7 Increased and transparent public involvement in risk assessment leading to increased objectivity

B7 Increased and transparent involvement of the private sector in biosafety processes

B7 Increased awareness, informed public participation and the resulting Informed action and decision making enabling different stakeholders to comply with the obligations under the Protocol

6. Information Exchange and data management

B7 Number, and regional balance, of countries effectively participating in the Biosafety Clearing-House (BCH)

B7 Number of national BCH nodes established and interoperable with the global BCH

B7 Number of National BCH Focal Points registered

B7 Number of countries with well maintained databases established and interoperable with others

B7 Number of new information networks linking relevant national, regional and other international systems established

B7 Number of requests for information by the public and other stakeholders handled by the BCH and the national nodes

B7 Frequency of use of information in databases for planning and decision-making

B7 Number of publications on biosafety - books, papers and journal articles- produced and disseminated

B7 Level of participation in, and use of, relevant global scientific information systems

B7 Increased availability of, and accessibility to, reliable and science-based biosafety information at all levels

B7 Effective documentation, information-exchange mechanisms and communication systems in place

B7 Existence of effective mechanisms for the collection, processing and diffusion of data related to biosafety

B7 Improved level of interoperability between different information systems and databases at various levels

B7 Increased availability of reliable information resulting in reduced cases of irrational inadvertent release of LMOs.

7. Scientific, technical and institutional collaboration

B7 Number of regional centres of excellence in biosafety established

B7 Number of joint regional research and training programmes initiated

B7 Level of harmonization of regulatory frameworks, including risk-assessment procedures, standards and guidelines

B7 Level of mutual acceptance of the validity of biosafety data at various levels

B7 Extent to which individual researchers and regulators are in contact and exchanging knowledge with appropriate peers at various levels

B7 Existence of mechanisms for national, regional and international consultations and cooperation on biosafety issues that span beyond institutional or national boundaries

B7 Extent to which existing regional organisations (e.g. OECD, ASEAN, AMCEN, etc) are engaged in promoting co-operation in biosafety

B7 Existence of mechanisms for sharing information between countries within respective regions/ sub-region.

B7 Improved interaction and coordination between different countries and agencies

B7 Increased harmonization of regulatory frameworks and efforts across sectors and regions

B7 Improved partnerships and leverage of resources

Improved regional and institutional collaboration resulting in reduced in incidences of adverse impacts of LMOs on biodiversity across national boundaries.

8. Transfer of technology and know-how

B7 Number of countries that have clearly identified their technological needs

B7 Number of joint North-South collaborative ventures established

B7 Level and quality of transfer of technology and know-how

B7 Increased access to and transfer of relevant technologies from developed to developing countries

B7 Increased accessibility to relevant technologies by most developing country Parties to the Protocol

B7 Private sector actively facilitating transfer of relevant technologies to developing countries in accordance with the relevant provisions of the Protocol.

B7 Improved access to up-to-date technologies and know-how in all countries resulting in increased effectiveness and levels of preparedness in early detection and prevention/ minimization of negative effects of LMOs on the biodiversity and human health.

9. Identification of LMOs and LMO-FFPs

B7 Number of countries with clear and consistent procedures and mechanisms for identification of LMOs

B7 Number of universally accepted LMO identification systems.

B7 Existence of clear and consistent LMO identification systems

B7 Regulators, operators and users of LMOs in a better position to make informed choices.

B7 Existence of clear identification systems of LMOs resulting in reduced incidences of injudicious transfer, handling and use of those with potential adverse effects on biodiversity.


3  / UNEP/CBD/ICCP/3/6, annex II.