1. Introduction to the Obligations of the Party to the Biosafety Clearing-House Manoranjan Hota

2. footer What is the Cartagena Protocol on Biosafety? The Cartagena Protocol on Biosafety is an international agreement (treaty), concluded and adopted in the framework of the Convention on Biological Diversity (CBD).

3. footer  Adopted under auspices of UNEP 1992, (Rio)  First global treaty to provide a comprehensive framework that addresses all aspects of biodiversity Convention on Biological Diversity

4. footer What is the purpose of the CPB? “ to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms (LMOs) resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and focusing, in particular, on transboundary movements”. This objective is to be achieved in accordance with the precautionary approach.

5. footer What is the role of the BCH? Under Art 20, the CPB established the BCH. The Protocol sets out two functions for the BCH: –To facilitate the exchange of scientific, technical, environmental and legal information on, and experience with, LMOs; and –To assist Parties to implement the Protocol.

6. footer While all Parties have obligations under the Protocol to make information available through the BCH, they also have benefits from using the BCH. For example, they can: –access information about the national laws, regulations and guidelines of other Parties; and information about the decisions and assessments of other countries relating to specific LMOs; –ensure, by posting up-to-date information on the BCH, that all potential exporters of LMOs to their country, or those who wish to transport LMOs across their territory, are aware of their national regulatory requirements; –access information about capacity-building and other assistance available to support implementation of the Protocol; and –ensure that the relevant authorities in other countries can quickly find out who to inform in the event of an accidental movement of LMOs into their territory. How Parties and non-Parties can benefit from the BCH?

7. footer What are the obligations of Parties regarding Posting and Updating information on the BCH? Parties have obligations under the Protocol to make some information available through the BCH. Art 20 of the CPB lists specific information that Parties must provide to the BCH. COP-MOP, In addition, may adopt decisions in the future regarding operational and technical aspects of the BCH, including additional information that should be made available through the BCH. Hence, Parties will have to monitor future decisions. (Therefore: not only registering but also regular visiting BCH-obligation).

8. footer What are the Types of Information Parties Need to make available? Some information should be available on the BCH as soon as the Protocol enters into effect for a country (i.e. as soon as it becomes a “Party” to the Protocol), e.g –The Party should inform the Secretariat of its Competent National Authority (or authorities). This information will then be placed on the BCH; Information on the Competent National Authority(ies) of many countries is already available on the BCH. –The Party should make available, through the BCH, information on existing laws, regulations or guidelines relevant to LMOs.

9. footer Information in the BCH

10. footer What are the Types of Information Parties Need to make available? (cont) Some information must be made available to the BCH when a country take certain steps, e.g. –If a Party enters into a bilateral, regional or multilateral agreement or arrangement regarding the transboundary movement of LMOs; or –If the Party adopts or amends laws, regulations or guidelines relevant to LMOs.

11. footer Advanced Information Agreement

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14. What are the Types of Information Parties Need to make available? (cont) Some information must be made available on the BCH when a country takes certain decisions, e.g. –If a Party takes a final decision on the importation or release of LMOs (e.g. under the AIA procedure); or –If the Party takes a final decision regarding domestic use, including placing on the market, of an LMO that may be subject to transboundary movement for direct use and food or feed, or for processing.

15. footer What are the Types of Information Parties Need to make available? (cont) Some information must only be made available only if certain events occur, e.g. –Information concerning cases of illegal transboundary movement of LMOs; or –Notification of an occurrence under the Party’s jurisdiction resulting in a release that leads to, or may lead to, an unintentional transboundary movement of an LMO.

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17. In order to fully participate in the BCH, Governments need to put in place lines of communication and information exchange to ensure that information that should be made available through the BCH is placed on the BCH; To assist Parties in doing so, the governing body has established some basic principles for the operation of the BCH. What is the functioning of the BCH?

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19. Parties must nominate National Focal Points for the BCH (or institutional focal points), who will: –Clear, for publishing, information registered on the BCH, including validation at a national level of records to make them publicly available through the central portal of the BCH; –Liaison with the Secretariat regarding the technical aspects of national participation in the BCH; –Liaison with the Secretariat regarding issues of relevance to the development and implementation of the BCH. What is the functioning of the BCH? (cont) BCH Focal Point

20. footer Institutions of the Protocol

21. footer Information in the BCH is open and accessible to all users; Since the information on the BCH is meant to be accessible to all, confidential information should NOT be posted on the BCH. Who can access the BCH?

22. footer Information that must go onto the BCH might originate in different governments departments and agencies; Therefore, only information that is validated by the BCH focal point, is posted on the BCH; Depending on the option for national participation chosen by a country, validation from the BCH FP may occur in several different ways. Who can put information on the BCH?

23. footer All information should be submitted to the BCH in an official United Nations language (Arabic, Chinese, English, French, Russian or Spanish); However, it is recognised that full information sources and comments that are linked to records in the BCH may be available only in a language of the government submitting the information and not in one of the six UN official languages. Language Requirements for the BCH

24. footer The MOP encourages Parties and other governments to provide courtesy translations of information in the BCH into one or more languages that are commonly used internationally. Language Requirements for the BCH (cont)

25. footer What information can be found on the BCH? There are several broad categories of information that are required by the BCH: –Laws and Regulations; –National Contacts; –Decisions and Declarations on LMOs; –Risk Assessments; –Unique Identification; –Capacity Building; –Roster of Experts; –National Reports submitted by Parties.

26. footer Laws and Regulations Existing national legislation, regulations and guidelines for implementing the Protocol, as well as information required by Parties for the AIA procedure (ongoing obligation); National laws, regulations and guidelines applicable to the import of LMOs intended for direct use as food or feed, or for processing (Article 11(5)) (ongoing requirement); Bilateral, multilateral and regional agreements and arrangements (Article 14) (requirement).

27. footer National Contacts Contact details for competent national authorities (Article 19) (critical information); Contact details for national focal points (Article 19) (liasing with the Secretariat); BCH national focal points (validation of information).

28. footer Decisions and Declarations on LMOs (cont) Risk Assessment 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(1)); 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); Declarations regarding the framework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11(6)) ;

29. footer Risk Assessment Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12(1)); LMOs subject to simplified procedures regarding intentional transboundary movement and exempted by a Party from the AIA procedure (Article 13(1)); Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity, and related information, including contact point for further information (Article 17); Illegal transboundary movements of LMOs (Article 25(3)).

30. footer Risk Assessment Summaries of risk assessments or environmental reviews of LMOs by regulatory processes and relevant information regarding products thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology (Article 20(3)(c)).

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32. Unique Identification The BCH contains a database providing a registry of unique identification classifications as a key to access records in the BCH, such as the OECDs unique identifiers for transgenic plant lines for LMOs-FFP.

33. footer Capacity Building Through the BCH, Parties and others can access important information about capacity-building and other assistance for implementation of the Cartagena Protocol; For example, the BCH contains databases of capacity- building opportunities and projects and initiatives; Governments can also register their capacity-building needs and priorities; Eventually, a database on capacity-building outcomes and lessons learned will also be added.

34. footer Roster of Experts The governing body of the Protocol has decided that access to the roster of experts will be maintained through the BCH; The roster of experts was established by the Governing Body of the Convention when the Protocol was adopted; Purpose is to provide advice and other support, as appropriate and upon request, to developing country Parties and Parties with economies in transition, –to conduct risk assessment, –make informed decisions, –develop national human resources and –promote institutional strengthening, associated with the transboundary movement of LMOs.

35. footer Roster of Experts (cont) Parties are encouraged to provide the Secretariat with an evaluation of any advice provided by experts from the roster and results achieved; Evaluations will be made available to the BCH in order to assist other Parties in making decisions about use of the roster of experts; Through the BCH nomination forms for the roster can be accesses to enable Parties to nominate experts; Guidelines for the use of experts from the roster, and information on the voluntary fund can also be accessed through the BCH.

36. footer Roster of Experts (cont) The expert nominated by a country can be of any nationality.

37. footer National reports submitted by Parties The Protocol requires each Party to submit a periodic report on its implementation of the Protocol to the Protocol’s governing body; These reports will be made available on the BCH.

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