Modalities of operation of the BCH (Annex to BS-I/3)

A. Role of the Biosafety Clearing-House

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:
1. 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));
2. 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);
3. Bilateral, multilateral and regional agreements and arrangements (Articles 14 paragraph 2 and 20 paragraph 3 (b));
4. 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));
5. Reports submitted by the Parties on the operation of the Protocol (Article 20 paragraph 3 (e));
6. Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6 paragraph 1);
7. Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17 paragraph 1);
8. Illegal transboundary movements of LMOs (Article 25 paragraph 3);
9. 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) (Articles 10 paragraph 3 and 20 paragraph 3(d));
10. Information on the application of domestic regulations to specific imports of LMOs (Article 14 paragraph 4);
11. 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);
12. 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));
13. Declarations regarding the framework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11 paragraph 6);
14. Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12 paragraph 1);
15. LMOs granted exemption status by each Party (Article 13 paragraph 1);
16. 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
17. Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20 paragraph 3 (c)).
Go to the top of the page
B. Characteristics of the Biosafety Clearing-House
The Biosafety Clearing-House shall be developed in a manner consistent with the following characteristics:
1. Guided by the principles of inclusiveness, transparency and equity, and open to all Governments;
2. Making use of a central portal to assist in the use and navigation of the Biosafety Clearing-House website;
3. 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;
4. Providing access to information to assist countries in capacity-building for implementation of the Protocol, as well as providing support to the Coordination Mechanism for 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), should it be established by the Conference of the Parties to the Convention on Biological Diversity serving as the meeting of the Parties to the Cartagena Protocol on Biosafety;
5. Providing access to the roster of experts on biosafety established by decision EM-I/3, paragraph 14, of the Convention of the Parties;
6. 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;
7. 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;
8. 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;
9. 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;
10. Making use of existing unique identification systems for living modified organisms, as appropriate, to facilitate searching and retrieval of information;
11. Facilitating navigation of the central portal website in all official United Nations languages;
12. 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;
13. 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;
14. Not including confidential data as such information shall be exchanged on a bilateral basis;
15. Building up its functions and activities in response to clear and identified demand, and based on further experience and available resources;
16. In close cooperation with relevant international organizations to maximize use of existing experience and expertise; and
17. Enhancing networking between 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.
Go to the top of the page
C. Administration of the Biosafety Clearing-House
The Secretariat of the Convention shall administer the central portal of the Biosafety Clearing-House. These functions will include:
1. Developing and maintaining the central portal and central databases to ensure the Biosafety Clearing-House is accessible, user-friendly, searchable, and understandable;
2. Identifying, reviewing and establishing, as necessary, common formats for reporting information to the Biosafety Clearing-House;
3. Providing hard copies of information available through the Biosafety Clearing-House, as and when requested by Parties;
4. 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;
5. Entering into administrative arrangements with relevant international, regional, sub-regional and national organizations and entities, as appropriate; and
6. 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.
Go to the top of the page
D. Role of the Biosafety Clearing-House focal points
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:
1. Active clearance 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;
2. Liaison with the Secretariat regarding the technical aspects of 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
3. Facilitation of the development of a network of multi-sectoral and interdisciplinary partners, as appropriate in the implementation process of the Biosafety Clearing-House.
Go to the top of the page
E. Technical oversight and advice
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.

Go to the top of the page
F. Obligations of partner organizations
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:
1. Nomination of an institutional focal point in the partner organization, responsible for liaison with the Secretariat;
2. Written confirmation by the relevant Party or government that responsibility for provision of this information has been conveyed to the institution in question;
3. 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;
4. 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.
Go to the top of the page
G. Reports on activities
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.
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.

Go to the top of the page
H. Periodic review
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.

Modalities of operation of the BCH (Annex to BS-I/3)

Sections