The Cartagena Protocol on Biosafety

ICCP 3 Recommendation III/3

Information-sharing (Article 20)

The Intergovernmental Committee on the Cartagena Protocol on Biosafety,

Noting with appreciation the outcomes of the inter-sessional activities related to information-sharing recommended at its second meeting,

Recalling that the pilot phase of the Biosafety Clearing-House is an ongoing activity being implemented in accordance with the recommendations made at its first meeting,

Recalling also the interconnection between national capacities, effective use of the Biosafety Clearing-House, and successful implementation of the Protocol,

Recognizing the importance of gaining experience with the operation of the pilot phase as a necessary prerequisite for making a decision on the modalities of operation of the Biosafety Clearing-House at the first meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol,

1. Urges Governments to further participate in the development of the pilot phase by registering and retrieving information, and to submit their views on the transition between the pilot phase and the fully operational and functional Biosafety Clearing-House no later than five months prior to the first meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol;

2. Welcomes the response from the Organisation for Economic Co-operation and Development to the Executive Secretary's request for views and proposals on unique identification systems, takes note of the adoption by the OECD of the Guidance for the Designation of a Unique Identifier for Transgenic Plants as a key to accessing in OECD product database and interoperable systems for the products of modern biotechnology which have been approved for commercial application, and recommends that OECD product database establish interoperability with the pilot phase of the Biosafety Clearing-House, incorporating the use of the OECD unique identifiers for transgenic plants, as appropriate and as they become available, and to further elaborate on its applicability for the Cartagena Protocol and to report on this to the first meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol;

3. Requests the Executive Secretary to invite relevant national and international organizations to provide views on the development of unique identification systems for classes of living modified organisms and their harmonization, that may be applicable to the Biosafety Clearing-House for inclusion in a synthesis report for consideration by the first meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol;

4. Recommends that a registry of any unique identification of living modified organisms used in the Biosafety Clearing-House be established under the central portal of the pilot phase;

5. Notes that the future development of the pilot phase of the Biosafety Clearing-House will be undertaken in accordance with the third note developed by the Bureau of the Intergovernmental Committee for the Cartagena Protocol on Biosafety on technical issues associated with the implementation of the pilot phase, as annexed to the present recommendation;

6. Recognizes the importance of developing a fully functioning Biosafety Clearing-House by the time of entry into force of the Protocol, and of meeting the capacity needs of all countries with respect to implementation and use of the Biosafety Clearing-House, and invites developed country Governments and other donors to provide financial support to ensure that, where appropriate, these recommendations and those contained in the third note of the Bureau can be implemented, including the continuing development of regional activities and of essential tools and required equipment, such as the tool kit and the templates to assist countries to develop their own national databases that are interoperable with the Biosafety Clearing-House;

7. Welcomes the efforts made by relevant intergovernmental organizations, including the International Centre for Genetic Engineering and Biotechnology, in making the pilot phase a valuable tool for the retrieval of official information, particularly in the area of risk assessment, with a view to facilitating decision-making and assisting countries in building capacity.

Annex

THIRD NOTE ON TECHNICAL ISSUES ASSOCIATED WITH THE DEVELOPMENT OF THE PILOT PHASE

I. BACKGROUND

1. Subsequent to the completion of the independent review of the pilot phase of the Biosafety Clearing-House, 1/ the Bureau of the ICCP, in line with the mandate given to it by the first meeting of the ICCP to provide management oversight on the implementation and development of the pilot phase of the Biosafety Clearing-House, has adopted the present note in order to assist the ICCP at its third meeting in its efforts aimed at developing a fully functional Biosafety Clearing-House at the time of entry into force of the Protocol.

2. The present note contains recommendations for further development of the Biosafety Clearing-House, taking into account the strengths and weaknesses that were identified in the report of the consultant in conducting the independent review, taking also into account the recommendations arising from the regional meetings held on the Biosafety Clearing-House, as well as what has been specified in the relevant recommendations of the ICCP regarding the objectives and operation of the pilot phase and the guidance on its monitoring and review.

3. In preparing these recommendations, the Bureau considered the outcome of the report of the independent review, the lessons learned to date in the development and implementation of the pilot phase of the Biosafety Clearing-House, and sought technical advice from the technical experts that had participated in previous liaison group meetings involved in the formulation of technical recommendations for the development and implementation of the pilot phase so far.

4. The Bureau recalled that one main objective of the pilot phase was to build experience and provide feedback for the development of a functional and accessible Internet-based Biosafety Clearing-House, and considered that the pilot phase has been able to demonstrate that a primarily Internet-based system, using open protocols and standards in order to enable the setting of a distributed system, provides a useful and satisfactory model for efficient information exchange under the Biosafety Protocol.

5. The Bureau also noted that, while the pilot phase provides a technological solution to meet the needs of most countries, another main objective of the pilot phase was to identify and address the capacity needs of countries with respect to the Biosafety Clearing-House, and that increased participation of all countries, including the issue of capacities development, needs to be further addressed to enable full participation in the development and implementation of the pilot phase of the Biosafety Clearing-House, in order to achieve the objective of providing appropriate feedback on the development of the pilot phase.

6. The Bureau recognizes also that the issue of the non-Internet based component of the Biosafety Clearing-House needs to be appropriately addressed with a view to cover the interim period at the time of entry into force of the Protocol, until all capacities necessary for full participation in the Internet-based component are in place.

II. RECOMMENDATIONS

1. Continued use of the Internet for implementation of the Biosafety Clearing-House pilot phase

(a) Ensure the provision of up-to-date information in the Biosafety Clearing-House by encouraging and facilitating countries and organizations to remain custodians of their own data, and through enhanced and continued use of a distributed Internet-based system for sharing data during the pilot phase of the Biosafety Clearing-House, and thereafter.

(b) Provide access to information and documents available through the pilot phase of the Biosafety Clearing-House in different formats (such as HTML, XML, PDF, compressed files and other major document formats), where possible.

2. Central database

(a) Ensure security of the Biosafety Clearing-House databases through the use of `best practice' procedures (e.g. firewalls, data encryption, etc.).

(b) Recalling the recommendation that countries establish a national focal point for the Biosafety Clearing-House, which will be responsible for validating data registered on the Biosafety Clearing-House for that country, ensure greater integrity of the Biosafety Clearing-House databases through standardization of validation procedures within partner organizations and user countries, and through the automated generation of reports relating to changes in the data to detect unauthorized registration or modification of data.

3. Participation in the pilot phase

(a) Continue to urge all Governments, relevant intergovernmental organizations and other participants to further contribute information to the pilot phase, as soon as possible, and to actively participate in its development and use, prior to the entry into force of the Protocol.

(b) Continue the use of open protocols and standards, and encourage partners to the Biosafety Clearing-House to adhere to and fully implement the interoperability guidelines for the Biosafety Clearing-House in initial and further development of their information systems.

(c) Promote collaboration between information-technology experts, national biosafety clearing-house focal points and partner organizations through, for example, the use of electronic discussion groups to facilitate cooperation and discussion.

(d) Continue the development and distribution of the offline Biosafety Clearing-House on CD-ROM.

(e) Develop templates and models (available online and on CD-ROM), to assist Governments in developing their own national biosafety databases that will be interoperable with the Biosafety Clearing-House.

4. Content of the Biosafety Clearing-House pilot phase

(a) Recognizing the role of the Biosafety Clearing-House in the implementation of the regulatory processes of the Protocol, ensure that access to information through the Biosafety Clearing-House (for example, scientific information) is provided on the basis of quality, neutrality, multidisciplinarity and relevance to the needs of Parties.

(b) Continue to seek partnerships with other international organizations (such as the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO)), or other scientific sources of information (such as that available through the clearing-house mechanism of the Convention, or ITIS or Species 2000) to add value and global relevance to the regulatory and scientific information provided through the Biosafety Clearing-House.

(c) Expand the capacity-building project database in the Biosafety Clearing-House (for example to include information on other available capacity-building opportunities, such as funding and training opportunities).

(d) To facilitate efficient retrieval of information, refer to existing harmonized unique identification systems for living modified organisms, on the basis of the work of other relevant international organizations, such as the OECD Guidance for the Designation of a Unique Identifier for Transgenic Plants.

5. Development of the Biosafety Clearing-House tool kit

(a) Continue to develop the links between specific sections of the Biosafety Clearing-House and the appropriate sections in the tool kit.

(b) Further develop the tool kit of the Biosafety Clearing-House to include more in-depth training materials, targeted for different audiences.

6. Capacity-building

(a) Recognizing that capacity-building is an ongoing process, and that capacity-building programmes should be developed with a long-term view to ensure sustainability, the Bureau noted that further development of capacity-building activities would be taken up by the ICCP at its third meeting.

(b) Encourage Governments to take into account the synthesis of capacity-building needs identified by the regions for implementation of the pilot phase of the Biosafety Clearing-House (UNEP/CBD/ICCP/3/5/Add.3) in the consideration of the agenda item on capacity-building (UNEP/CBD/ICCP/3/6).

(c) Invite the Global Environment Facility and other donors to take into account these identified needs in providing assistance to developing countries, in particular the least developed and the small island developing States among them, and Parties with economies in transition.

(d) Collaborate with existing initiatives and organizations, such as the International Telecommunications Union, to assist in ensuring full and equitable access to the Internet by all regions of the world.

(e) Make available a telephone and fax hotline to offer uninterrupted access to, and dissemination of, information available on the Biosafety Clearing-House.

7. Administration

(a) Recalling the establishment of the Biosafety Clearing-House under paragraph 1 of Article 20 of the Protocol, as part of the clearing-house mechanism of the Convention, to facilitate the exchange of relevant information on living modified organisms, and to assist Parties to implement the Protocol,

(b) Recalling the recommendation of the first meeting of the ICCP that, given the distinctly different roles that the clearing-house mechanism and the Biosafety Clearing-House have, the latter shall be run, at the technical and operational level, as a distinct element, 2/

(c) The ICCP Bureau recommends that the Biosafety Clearing-House be administered and operated in a manner that allows Parties to the Protocol to clearly recognize its status and identity as a tool to implement obligations under the Biosafety Protocol.

8. Monitoring and review

(a) The Bureau will continue to provide management oversight on the implementation and development of the Biosafety Clearing-House, as well as technical guidance on the development of the pilot phase of the Biosafety Clearing-House, utilizing the advice of technical experts, where appropriate.

(b) The ICCP Bureau recommends that future review of the development of the Biosafety Clearing-House should aim to include consultation with a wide variety of countries and participating organizations.


1 / UNEP/CBD/ICCP/3/5/Add.1; UNEP/CBD/ICCP/3/INF/10.

2 / UNEP/CBD/ICCP/1/9, annex.