Cartagena Protocol on Biosafety:

1. Cartagena Protocol on Biosafety: Capacity Building Projects in helping Parties meet their obligations Charles Gbedemah, UNEP/GEF, Nairobi, Kenya Training of Trainers Workshop for Regional Advisors, Bangkok, Thailand, 15 – 27 May 2006

2. HISTORY 1992: UNCED - AGENDA 21 1992: ADOPTION OF THE CBD 2000: ADOPTION BIOSAFETY PROTOCOL 2000: GEF STRATEGY ON BIOSAFETY 2001: DEVELOPMENT PROJECTS 2002: IMPLEMENTATION PROJECTS 2004: BCH PROJECTS

3. 1992: UNCED AGENDA 21, CHAPTER 16 • MODERN BIOTECHNOLOGY OFFERS PROMISES FOR: • SUSTANAIBALE FOOD PRODUCTION • IMPROVED HEALTH CARE • ENVIRONMENTAL PROTECTION

4. AGENDA 21, CHAPTER 16: “…. MANKIND CAN ONLY THEN BENEFIT FULLY FROM A NEW TECHNOLOGY IF ADEQUATE SAFETY MECHANISMS ARE SET IN PLACE….”

5. 1992: THE CONVENTION ON BIOLOGICAL DIVERSITY: • ART. 8.G: “IN SITU CONSERVATION OF BIODIVERSITY”>> OBLIGATION TO DEVELOP NATIONAL BIOSAFETY MECHANISMS • ART. 19.3: “HANDLING BIOTECHNOLOGY AND DISTRIBUTION OF ITS BENEFITS”>> CONSIDER A PROTOCOL ON BIOSAFETY

6. THE BIOSAFETY PROTOCOL • 1995: DECISION TO DEVELOP A PROTOCOL FOCUSING ON THE TRANSBOUNDARY MOVEMENT OF LMOs (GMOs) • 1996 – 2000: NEGOTIATIONS • 2000 : ADOPTION • 2003: 11th SEPTEMBER, PROTOCOL COMES INTO FORCE.

7. The Cartagena Protocol I. Overview of the Protocol II. Rights and Obligations

8. Cartagena Protocol on Biosafety Embrace BenefitsEnsure adequate safety A balanced approach toward Biotech

9. Objectives • Objectives: Protection of biodiversity and human health • Focus: Transboundary movements of LMOs

10. Scope • Applying to: • Transboundary movement (main focus) • Transit • Handling • Use • Exception: - Pharmaceuticals for humans covered by other relevant international agreements or organizations

11. Categories of LMOs Three categories of LMOs: • Intentional introduction into the environment (e.g. seed for planting) • Intended for direct use as food or feed or for processing (e.g. genetically modified corn for human consumption) • For contained use (e.g. for laboratory use)

12. The Protocol Architecture Objective:Protection of biodiversity and human health Focus: Transboundary movements of LMOs Precautionary Approach • AIA Procedure • Procedure for FFP Handling transport packaging Identification • documentation for shipment Risk Assessment Risk Management Info Sharing (BCH) SUPPORTING MECHANISMS BCH, Capacity Building, Compliance, Liability

13. Section IIRights and ObligationsA. Two Procedures

14. AIA procedure Procedural steps: Acknowledgement (Art.9) (Importing Party Within 90 days) Notification (Art.8) (Exporters) Decision-making(Art.10) (maximum 270 days) Review of decision (Art.12)

15. AIA procedure: Application • Application: First intentional transboundary movement of LMOs for intentional introduction into the environment of the Party of import • Exemption Not to apply LMOs identified by decisions of COP/MOP (Art.7.4)

16. AIA procedure: Discretions • Opt out of AIA by Applying: • Domestic framework - Art.9.2 (c) • Simplified Procedure: Inform the BCH imports of LMOs to be exempted from AIA (Art.13) Conditions: Domestic regulatory framework or adequate safety measures in place

17. AIA procedure: Decision-making Decision- Making Risk Assessment (Basis) Precaution

18. Procedure for LMO-FFPs (1) • Sharing information: • - Informing BCH of final decisions on domesticuse of LMOs within 15 days - Providing information specified in Annex II - Ensuring Accuracy of information • Decision-making on the import: Subject to domestic regulatory framework • Precaution (Art.11.8)

19. Procedure for LMO-FFPs (2) Developing and EIT Parties in the absence of domestic regulatory framework • Risk assessment based on the Protocol • Decision making within 270 days • Silence not to imply consent or refusal

20. Section IIIB.Risk Assessment Risk Management

21. Risk Assessment Risk assessment - basis for decision-making • Parties may subject all LMOs to risk assessment prior to decisions on import • How to conduct - In a scientifically sound manner - In accordance with a technical annex of the Protocol(Annex III)

22. Risk Management Establish strategies and mechanisms to regulate and control risks of LMOs identified in the risk assessment (Art.16)

23. Section IIC.Handling, TransportPackaging and Identification (Art.18)

24. Article 18 General Obligations: • Take measures to ensure LMOs handled, packaged and transported under conditions of safety Specific Obligations: • Require documentation for shipment of LMOs - identification

25. Documentation Requirements • Identification of LMOs - LMO-FFP:“May contain” - LMO for introduction into the environment:Clear identification/Declaration of conformity with the Protocol - LMO for contained use: clear identification/requirements for safe handling

26. Current MOP 3 Issue, Curitiba, Brazil, 13 – 17th March 2006 • Handling,transport, packaging and identification (Art 18) • Risk Assessment and risk management: (Art 15 & 16) • Liability and redress (Art 27) • Subsidiary bodies (Art 30) • Monitoring and reporting (Art 33) • Assessment and Review (Art 35)

27. Decision of COP-MOP 3 • Adopted a decision that requires clear and detailed identification requirements for shipments LMO-FFPs • A two-stage approach is set out for cases where the identity of the LMO shipment is not known

28. Decision of COP-MOP 3 • Where the identity of the LMO is known through “means such as identity preservation systems”, the shipment must be identified as one that “contains” LMOs that are for direct use as food or feed, or for processing

29. Decision of COP-MOP 3 • Where the identity of the LMO is not known through “means such as identity preservation systems” the shipment can be identified as one that “may contain” one or more LMOs This requirement is subject to review and assessment at the 5th Meeting of the Parties (2010), “with a view to considering a decision” at the 6th Meeting of the Parties (2012) to ensure that the shipment “contains” LMO-FFPs. (4-6 years interim period)

30. Decision of COP-MOP 3 • Both case: the documentation accompanying them must include the following details: - that the LMOs are not intended for intentional introduction into the environment- the common, scientific and, where available, commercial names of the LMOs - the transformation event code of the LMOs or, where available, as a key to accessing information in the Biosafety Clearing House (BCH), its unique identifier code - the internet address of the BCH for further information

31. Decision of COP-MOP 3 • “transformation event code”, which distinguishes between the different transgenic lines • Some LMOs have a “unique identifier code” which acts as a key to accessing full information about the LMO in a database. • The BCH is a publicly accessible internet based database which is administered by the Secretariat of the Convention on Biological Diversity which provides some information about LMOs, and is part of the implementation of the Biosafety

32. Section IID.Information Sharing

33. Information Sharing Obligation to submit the Information to BCH • National Law and regulation • Bilateral/Regional/Multilateral Agreements • Summaries of Risk Assessment • Decisions on importation and release of LMOs • National reports • Decisions under AIA and Article 11 procedures • Contact details for CAN, NFP and emergency contacts

34. Public Participation • Promote public awareness and education • Facilitate public access to BCH • Consult the public in decision-making • Make result of decisions available MOP Decision: MOP2 considered options of cooperation and implementation

35. Section IIE.Other Provisions

36. Socio-Economic Considerations In reaching decisions on import of LMOs: • May take into account socio-economic considerations arising from the impact of LMOs on the conservation and sustainable use of biodiversity, especially with regard to the value of biodiversity to indigenous and local community • Consistent with Parties’ international obligations

37. MOP Decision Decision BS-I/12 MOP 2 considered: Cooperation on research and information exchange on any socio-economic impacts of LMOs, especially on indigenous and local communities

38. Questions ? and Answers ? Dev Project BCH Project ? ? Protocol ? Obligations Imp. Project Tools

40. Country Process for Meeting the Obligations under the Cartagena Protocol

41. Question ! What are Parties doing to meet these obligations? (2 step approach) • Draft NBF with the following 5 common components • Integrate the NBFs into their national systems

42. National Biosafety Frameworks key components • Biosafety Policy • Regulatory regime • System to handle requests (administrative, risk assessment & management, decision making) • Follow up activities (enforcement, monitoring for environmental effects) • Public Awareness and Participation

43. GEF Initial Strategy on Biosafety, 2000 ACTIVITIES OF GEF INITIAL STRATEGY • A project to assist in developing National Biosafety Frameworks (NBFs) • A limited number of demonstration projects to assist in implementing the National Biosafety Frameworks; • Support for countries to participate in the Biosafety Clearing House • Coordination with other organizations to provide biosafety-related assistance • Enhancement of scientific and technical advice to GEF on biosafety issues

44. UNEP-GEF Projects for National Biosafety Frameworks 1. Development of NBFs …Up to 130 countries developing an NBF 3. Implementation Projects … 8 Demonstration Projects on Implementation of NBF 2. BCH Project …Up to 139 countries

45. UNEP-GEF Development of NBFs Dates:Started June 2001 and ending December 2006 Duration: National projects average 24 months Total cost: $36 million from the GEF, plus co-financing of $12 million from UNEP and participating countries. Participants: Up to 130 countries – Each country budget of between 100,000 to 200,000 US $ plus 50% in additional co-financing from country

46. GEF Initial Strategy on Biosafety FROM: the initial country status TO: an advanced draft NBF ready for process in government 1. Development Phase FROM: a draft or approved NBF TO: a fully operational NBF 2. Implementation Phase

47. Suggested Country Road Map for the development of National Biosafety Framework (NBF) Establish project management structures Surveys of: • Existing capacity building programmes • Current status of biotechnology • Existing legislation • Regional mechanisms for harmonisation • Other issues as identified by country • National expertise in relevant fields National workshop for stakeholders to: review findings, identify gaps and needs, and to decide priorities for NBF Prepare draft of National Biosafety Framework Stakeholder workshops to identify key components of NBF and discuss final draft Training workshops on different NBF components as required Awareness workshopsfor target groups Roster of national experts

48. Tools for Development of NBFs • Regional Coordinators give support to countries • Training to help financial and project management • Toolkits help guide through Phases of the Project • Workshops help to build capacity • Meetings provide opportunity to build networks • Technical advice made available to countries • Promotion of cooperation with all other relevant organizations, countries, etc • Information needs serviced from central point

49. Legislation Surveys: Gaps identified • Lack of primary legislation • Existing legislation not having enforcement mandates • Statutes not “LMO issue sensitive” or Cartagena Protocol compliant Provide useful guidelines in the elaboration of the relevant legislation on Biosafety. • Challenge for countries • Modify existing legislation • A new legislation as part of existing one • A new legislation entirely

50. Administrative Systems Gaps Need for competent authority/authorities Institutional arrangements for permits Operational modalities of the authority Enforcement arrangements Lack of national database (BCH)