Information-sharing and the Biosafety Clearing-House (Article 20): modalities of operation of the Biosafety Clearing-House

The Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety,

Having examined the note by the Executive Secretary, (UNEP/CBD/BS/COP-MOP/1/5), reviewing the progress in the development and implementation of the pilot phase of the Biosafety Clearing-House,

Taking note of the recommendations made by the Intergovernmental Committee for the Cartagena Protocol on Biosafety on the development of the pilot phase of the Biosafety Clearing-House,

Taking note that the progress made and experience gained during the implementation of the pilot phase has produced valuable insights as to the future development of the Biosafety Clearing-House,

Recognizing that some developing countries, in particular the least developed and small island developing states among them, either do not have access to the Internet, or experience periodically unreliable telecommunication networks, and/or unaffordably high cost of access to the Internet, as well as inadequate information technology and competent human resources capacity to access and manage Internet-based information,

Welcoming the proposed UNEP-GEF add-on project "Building Capacity for Effective Participation in the Biosafety Clearing-House" and calling on the Global Environment Facility to extend support to all eligible countries,

1. Approves the transition of the pilot phase of the Biosafety Clearing-House to the fully operational phase;

2. Adopts the modalities of operation of the Biosafety Clearing-House that are contained in the annex to this decision;

3. Welcomes the participation in the pilot phase of governments and international organizations that have provided information to the Biosafety Clearing-House, either directly through the Management Centre of the Central Portal, or through the development of nodes that are interoperable with the Central Portal of the Biosafety Clearing-House;

4. Encourages Parties, governments and other users to develop national, regional, sub-regional and institutional nodes that are interlinked with the Central Portal, in accordance with minimum standards for partnership as outlined in Section F of the Annex hereto. It is suggested that these nodes and/or partnerships would focus initially on:

5. Urges all Parties, governments and other users to provide relevant information to the Biosafety Clearing-House as soon as possible, including information pertaining to decisions on the release or import of living modified organisms taken prior to entry into force of the Protocol;

6. Invites relevant international, regional, subregional and national organizations and entities willing to offer their cooperation as active partners in the implementation of the Biosafety Clearing-House to communicate the details of their offer and requests the Executive Secretary of the Secretariat to enter into collaborative arrangements and to report to its second meeting on the results of such arrangements;

7. Calls upon each Party that has not yet done so to designate an appropriate national focal point for the Biosafety Clearing-House;

8. In this regard, invites Governments, organizations and other users interested in entering into a partnership with the Biosafety Clearing-House to nominate an appropriate focal point to carry out this role;

9. Requests the Executive Secretary to further develop non-Internet based biosafety clearing-house mechanisms that effectively interface with the Internet-based technology, and are consistent with the characteristics and administrative requirements detailed in sections B and C of the annex to the present decision, and to make them available to Parties and Governments upon request;

10. Requests the Executive Secretary to continue analysing the identified capacity-building and financial requirements of developing countries, in particular the least developed and small island developing States among them, and countries with economies in transition, as well as countries that are centres of origin and centres of genetic diversity, to enable their active participation in the Biosafety Clearing-House. This information will be provided to Governments, intergovernmental and non-governmental organizations with a role in capacity-building;

11. Calls upon the international community to make additional voluntary contributions to meet the capacity-building needs of countries with respect to the implementation of national components of the Biosafety Clearing-House;

12. Decides to review the implementation of the Biosafety Clearing-House at its second meeting and requests the Executive Secretary to submit a progress report to that meeting, with a view to developing a longer-term programme of work for the Biosafety Clearing-House.

Annex

MODALITIES OF OPERATION OF THE BIOSAFETY CLEARING-HOUSE

A. Role of the Biosafety Clearing-House

1. The role of the Biosafety Clearing-House in the provision and exchange of information in support of implementation of the Protocol, is clearly articulated in the Protocol. At a minimum, the Biosafety Clearing-House has a role in providing access to information relating to:

(a) Existing national legislation, regulations and guidelines for implementing the Protocol, as well as information required by Parties for the advance informed agreement procedure (Article 20 paragraph 3 (a));

(b) National laws, regulations and guidelines applicable to the import of LMOs intended for direct use as food or feed, or for processing (Article 11 paragraph 5);

(c) Bilateral, multilateral and regional agreements and arrangements (Articles 14 paragraph 2 and 20 paragraph 3 (b));

(d) Contact details for competent national authorities (Articles 19.2 and 19.3), national focal points (Articles 19 paragraph 1 and 19 paragraph 3), and emergency contacts (Article 17 paragraph 3 (e));

(e) Reports submitted by the Parties on the operation of the Protocol (Article 20 paragraph 3 (e));

(f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6 paragraph 1);

(g) Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17 paragraph 1);

(h) Illegal transboundary movements of LMOs (Article 25 paragraph 3);

(i) Final decisions regarding the importation or release of LMOs (i.e. approval or prohibition, any conditions, requests for further information, extensions granted, reasons for decision) (Article 10 paragraph 3 and Article 20 paragraph 3(d));

(j) Information on the application of domestic regulations to specific imports of LMOs (Article 14 paragraph 4);

(k) Final decisions regarding the domestic use of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing (Article 11 paragraph 1);

(l) Final decisions regarding the import of LMOs intended for direct use as food or feed, or for processing that are taken under domestic regulatory frameworks (Article 11 paragraph 4) or in accordance with annex III (Article 11 paragraph 6) (requirement of Article 20 paragraph 3(d));

(m) Declarations regarding theframework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11 paragraph 6);

(n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12 paragraph 1);

(o) LMOs granted exemption statusby each Party (Article 13 paragraph 1);

(p) Cases where intentional transboundary movement may take place at the same time as the movement is notified to the Party of import (Article 13 paragraph 1); and

(q) Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20 paragraph 3 (c)).

B. Characteristics of the Biosafety Clearing-House

2. The Biosafety Clearing-House shall be developed in a manner consistent with the following characteristics:

(a) Guided by the principles of inclusiveness, transparency and equity, and open to all Governments;

(b) Making use of a central portal to assist in the use and navigation of the Biosafety Clearing-House website;

(c) Containing a central database for making information available through the Biosafety Clearing-House, that stores, at a minimum, information from countries without a national database, as well as incorporating information provided by interoperable information-exchange systems;

(d) Providing access to information to assist countries in capacity-building for implementation of the Protocol, as well as providing support to the Coordination Mechanismfor the Action Plan for Building Capacities for the Effective Implementation of the Protocol (which includes databases on capacity-building activities; identified national needs and priorities), established pursuant to decision BS-I/5;

(e) Providing access to the roster of experts on biosafety established by decision EM-I/3, paragraph 14, of the Convention of the Parties;

(f) As a decentralized mechanism where appropriate, making use of the Internet as a delivery mechanism, as well as other mechanisms to ensure the participation of Parties without Internet access;

(g) Making use of common formats to report information, such as decision information, laws and regulations, and national contact details, using a modular data structure where possible;

(h) Making use, where appropriate, of a controlled vocabulary to describe records, which can be translated into the official United Nations languages, to facilitate the ability to search for records in all languages;

(i) Making use of metadata about each record (i.e., descriptive identifiers such as name, date, author, etc.), to facilitate the submissions, searching, location and retrieval of information;

(j) Making use of existing unique identification systems for living modified organisms, as appropriate, to facilitate searching and retrieval of information;

(k) Facilitating navigation of the central portal website in all official United Nations languages;

(l) Requiring that all information be submitted to the Biosafety Clearing-House in an official language of the United Nations, while recognizing that full information sources and documents that are linked to records from the Biosafety Clearing-House may be available only in a language of the submitting Government and not in an official language of the United Nations;

(m) Encouraging Parties and other Governments to also provide courtesy translations of information in the Biosafety Clearing-House into one or more languages that are commonly used internationally, in order to minimize the burden of translation;

(n) Not including confidential data as such information shall be exchanged on a bilateral basis;

(o) Building up its functions and activities in response to clear and identified demand, and based on further experience and available resources;

(p) In close cooperation with relevant international organizations to maximize use of existing experience and expertise; and

(q) Enhancing networkingbetween national, regional, sub-regional and international centres with relevant expertise, as well as non-governmental organizations and the private sector, to maximize use of existing experience and to minimize any duplication of work.

C. Administration of the Biosafety Clearing-House

3. The Secretariat of the Convention shall administer the central portal of the Biosafety Clearing-House. These functions will include:

(a) Developing and maintaining the central portal and central databases to ensure the Biosafety Clearing-House is accessible, user-friendly, searchable, and understandable;

(b) Identifying, reviewing and establishing, as necessary, common formats for reporting information to the Biosafety Clearing-House;

(c) Providing hard copies of information available through the Biosafety Clearing-House, as and when requested by Parties;

(d) Assisting governments, on request, in the use of the Biosafety Clearing-House central portal, and coordinating the development of national, regional, subregional and institutional nodes that are interlinked with the central portal;

(e) Entering into administrative arrangements with relevant international, regional, sub-regional and national organizations and entities, as appropriate; and

(f) Performing such other administrative functions as are directed by the Conference of the Parties serving as the meeting of the Parties to the Protocol in other decisions.

D. Role of the Biosafety Clearing-House focal points

4. National focal points (or, where appropriate, Institutional Focal Points) for the Biosafety Clearing-House shall be nominated to liaise with the Secretariat regarding issues of relevance to the development and implementation of the Biosafety Clearing-House, whose functions shall include the following roles and responsibilities:

(a) Activeclearance for publishing information registered on the Biosafety Clearing-House, including validation at a national level of records to make them publicly available through the central portal;

(b) Liaison with the Secretariat regarding the technical aspectsof national participation in the Biosafety Clearing-House, as well as provision of advice on further technical development including, inter alia, suggestions for improvements to the layout and system specifications of the central portal and central databases; and

(c) Facilitation of the development of a network of multi-sectoral and interdisciplinary partners, as appropriate in the implementation process of the Biosafety Clearing-House.

E. Technical oversight and advice

5. The Secretariat may seek assistance from an informal advisory committee, constituted and coordinated by the Executive Secretary in a transparent manner, with a particular focus on providing guidance with respect to resolution of technical issues associated with the ongoing development of the Biosafety Clearing-House.

F. Obligations of partner organizations

6. Relevant international, regional, sub-regional and national organizations and entities willing to offer their cooperation as active partners in the operation of the Biosafety Clearing-House shall follow specific interoperability guidelines for information-sharing, to be prepared by the Secretariat for this purpose. Where partner institutions are hosting information that is required by the Protocol to be made available to the Biosafety Clearing-House, the following minimum standards will apply:

(a) Nomination of an institutional focal point in the partner organization, responsible for liaison with the Secretariat;

(b) Written confirmation by the relevant Party or Government that responsibility forprovision of this information has been conveyed to the institution in question;

(c) Guaranteed maintenance of their information-exchange system, as well as provision of 24 hour/7 day a week availability and open access to the required information;

(d) If these standards cannot be maintained, or if a partner does not wish to continue to provide information to the Biosafety Clearing-House, all data or information subject to this partnership shall be transferred to the central databases maintained by the Secretariat.

G. Reports on activities

7. Once a year, the Quarterly Report prepared by the Secretariat shall include information on the operation of the Biosafety Clearing-House, including information such as the number of and regional distribution of national focal points; the number of records available through the Biosafety Clearing-House; and partnership arrangements that have been entered into. These reports shall also be made available through the Biosafety Clearing-House itself.

8. In addition, Parties and other users of the Biosafety Clearing-House are encouraged to provide the Secretariat with feedback on their experiences with its operation. Such feedback shall be made available to the Conference of the Parties serving as the meeting of the Parties, and may serve as a basis for further development of the Biosafety Clearing-House.

H. Periodic review

9. The implementation and operation of the Biosafety Clearing-House shall be subject to periodic review, which should aim to include consultation with a wide variety of countries and participating organizations. The first review should be undertaken by the second meeting of the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol, with a view to developing a longer-term programme of work. Periodic reviews should then take place in accordance with Article 35 of the Protocol.