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
The presentation will have five sections. A short introduction on the Protocol’s parent Convention – the Convention on Biodiversity and the negotiation background of the the Protocol. Then my colleague, Xueman Wang will give you a whole picture of the Protocol and the CBD cooperation with other international organizations. After this, I will talk briefly about the on-going work under the CBD process on invasive alien species. Finally I will explore areas of cooperation between CBD and WTO to pursue our common objective of mutual supportiveness.

2. HISTORY 1992: UNCED - AGENDA 21 1992: ADOPTION OF THE CBD
2000: ADOPTION BIOSAFETY PROTOCOL
2000: GEF STRATEGY ON BIOSAFETY : 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
The presentation will have five sections. A short introduction on the Protocol’s parent Convention – the Convention on Biodiversity and the negotiation background of the the Protocol. Then my colleague, Xueman Wang will give you a whole picture of the Protocol and the CBD cooperation with other international organizations. After this, I will talk briefly about the on-going work under the CBD process on invasive alien species. Finally I will explore areas of cooperation between CBD and WTO to pursue our common objective of mutual supportiveness.

8. Cartagena Protocol on Biosafety
Embrace Benefits Ensure adequate safety
A balanced approach toward Biotech
In early 1990s, Biotechnology is growing rapidly and LMOs are traded across borders. There was a sense of urgency to develop an international regulatory framework to address safe transfer, handling and use of LMOs.
In 1995, Parties to the Convention responded to this challenge by launching negotiations on a legally binding agreement that would address potential risks posed by LMOs. They recognized while modern biotechnology has great potential for human being, it must be developed and used with adequate safety measures for the environment and human health.
After five year intensive negotiation, the Protocol was adopted in January The negotiation process was open to all countries and organizations, and participated by more than one hundred countries, NGOs and industry. The adoption of the Protocol was a historical moment and reflected a broad consensus on the need to take action on biosafety.
The Protocol sets out a comprehensive framework for international cooperation aimed at ensuring safety of transboundary movements of LMOs, or in other words, trading in LMOs. It strikes a balanced approach to meet the needs of consumers, industry and environment. (My colleague will further explain such an approach shortly)
(See next slide)

9. Protection of biodiversity and human health
Objectives
Objectives:
Protection of biodiversity and human health
Focus:
Transboundary movements of LMOs
In early 1990s, Biotechnology is growing rapidly and LMOs are traded across borders. There was a sense of urgency to develop an international regulatory framework to address safe transfer, handling and use of LMOs.
In 1995, Parties to the Convention responded to this challenge by launching negotiations on a legally binding agreement that would address potential risks posed by LMOs. They recognized while modern biotechnology has great potential for human being, it must be developed and used with adequate safety measures for the environment and human health.
After five year intensive negotiation, the Protocol was adopted in January The negotiation process was open to all countries and organizations, and participated by more than one hundred countries, NGOs and industry. The adoption of the Protocol was a historical moment and reflected a broad consensus on the need to take action on biosafety.
The Protocol sets out a comprehensive framework for international cooperation aimed at ensuring safety of transboundary movements of LMOs, or in other words, trading in LMOs. It strikes a balanced approach to meet the needs of consumers, industry and environment. (My colleague will further explain such an approach shortly)
(See next slide)

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 II Rights and Obligations A. Two Procedures
The presentation will have five sections. A short introduction on the Protocol’s parent Convention – the Convention on Biodiversity and the negotiation background of the the Protocol. Then my colleague, Xueman Wang will give you a whole picture of the Protocol and the CBD cooperation with other international organizations. After this, I will talk briefly about the on-going work under the CBD process on invasive alien species. Finally I will explore areas of cooperation between CBD and WTO to pursue our common objective of mutual supportiveness.

14. Decision-making(Art.10)
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
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. Decision- Making Precaution
AIA procedure: Decision-making
Decision-
Making
Risk Assessment
(Basis)
Precaution

18. Procedure for LMO-FFPs (1)
Sharing information:
- Informing BCH of final decisions on domestic use 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 III B. 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 II C. Handling, Transport Packaging and Identification (Art

24. General Obligations: Article 18
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 II D. 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. Promote public awareness and education Facilitate public access to BCH
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
Trade ban is identified as one of the measures that Parties to the protocol may take regarding the import of LMOs for intentional introduction into the environment under the AIA procedure. However such measure must be taken based on a risk assessment.
The risk assessment is elaborated in the Protocol in detail. It should be carried out in a scientific sound manner. A technical annex is attached containing principles and methodologies on how to conduct a risk assessment.
Regarding who would conduct a risk assessment, the Party of import may conduct it for itself, but it may require the notifier or exporter to bear the costs. It may also require the exporter to carry out the risk assessment.

35. Section II E. 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
Trade ban is identified as one of the measures that Parties to the protocol may take regarding the import of LMOs for intentional introduction into the environment under the AIA procedure. However such measure must be taken based on a risk assessment.
The risk assessment is elaborated in the Protocol in detail. It should be carried out in a scientific sound manner. A technical annex is attached containing principles and methodologies on how to conduct a risk assessment.
Regarding who would conduct a risk assessment, the Party of import may conduct it for itself, but it may require the notifier or exporter to bear the costs. It may also require the exporter to carry out the risk assessment.

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 ? Protocol BCH Project Dev Project Obligations
Tools
Imp. Project
Obligations
BCH Project ?

40. Country Process for Meeting the Obligations under the Cartagena Protocol
The presentation will have five sections. A short introduction on the Protocol’s parent Convention – the Convention on Biodiversity and the negotiation background of the the Protocol. Then my colleague, Xueman Wang will give you a whole picture of the Protocol and the CBD cooperation with other international organizations. After this, I will talk briefly about the on-going work under the CBD process on invasive alien species. Finally I will explore areas of cooperation between CBD and WTO to pursue our common objective of mutual supportiveness.

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. National Biosafety Framework (NBF)
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 workshops for 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)

51. UNEP-GEF Biosafety Projects
Development of NBFs :pilot enabling activities in 18 countries
1. Development of NBFs
126 countries developing an NBF
3. Implementation Projects
… 8 demonstration projects (out of 12) on Implementation of NBF
2. BCH Project
…Up to 139 countries to help use and access BCH

52. Main project characteristics
 Addresses national priorities
 Country-driven & managed
 Meet CPB country’s obligations

53. Implementation Phase Issues to consider:
Objective 1:
To integrate Biosafety and Biotechnology into national and development plans (Policy)
Some possible outcomes (activities dev to meet outcomes):
Biotechnology and biosafety recognized as a sustainable development issue in NBSAP, NEAP and Biotechnology and Biosafety Strategy and Action Plan
Strengthened political and public support for biotech/biosafety policy
Enabling mechanisms to adapt policy to changing needs

54. Implementation Phase Issues to consider: (cont’d)
Objective 2:
To establish a fully functional and responsive regulatory regime in line with CP and national needs on biosafety Some possible outcomes (activities dev to meet outcomes):
Regulatory regime in place that is consistent with CP and other domestic and international obligations
Regulatory regime published and made accessible to all stakeholders
Application and enforcement of the regulatory regime

55. Implementation Phase Issues to consider: (cont’d)
Objective 3:
To have fully functional national system for handling requests and applications
Some possible outcomes (activities dev to meet outcomes):
Establishment of a fully functional and workable system for handling applications, their consideration and decision making
A fully functional decision-making system
A fully functional administrative system
A fully functional system for handling, storing and exchanging information including the use of the BCH

56. Implementation Phase Issues to consider: (cont’d)
Objective 4:
To set up a workable and fully functional system for monitoring and enforcement
Some possible outcomes (activities dev to meet outcomes):
Establishment of roles and responsibilities for monitoring and enforcement
Strengthen systems for enforcement
Emergency response procedures established and operational

57. Implementation Phase Issues to consider: (cont’d)
Objective 5:
To establish a fully functional systems for: Public awareness, Education, Participation, Access to information
Some possible outcomes (activities dev to meet outcomes):
National system for access and sharing of information
Strengthen system for public awareness and education
Strengthen system for public participation in decision-making

58. UNEP-GEF Biosafety Projects
1. Development of NBFs
120 countries developing an NBF
3. Implementation Projects
… 8 demonstration projects (out of 12) on Implementation of NBF
2. BCH Project
…Up to 139 countries to help use and access BCH

59. Background
Project developed as direct response to country needs for access and use of the BCH;
Developed in collaboration with the SCBD; and
Fits within the GEF Initial Strategy for assisting countries to prepare for entry into force of the Cartagena Protocol.…. to support activities for countries to participate in BCH, once the terms of reference are agreed.

60. Project Objectives
To develop core human resources in use and access of BCH in countries;
Establish an appropriate national BCH infrastructure to enable eligible countries to fully participate in, and benefit from, the Biosafety Clearing-House (BCH).

61. BCH Regional Advisors BCH Regional Advisors will:
Assist countries in making choice for type and style of national participation in the BCH;
Deliver training activities, with national counterparts, in the use and access of the BCH; and
Assist in making choice of national participation in the BCH operational.

62. Objective: Establish Appropriate National BCH Infrastructure
Support for:
Making a choice for national participation in the BCH;
Purchase and set up of equipment required for the national BCH;
Collaboration with Governments of:
Canada;
Switzerland; and
USA

63. Regional BCH
Some countries have requested a regional BCH structure that would allow country web presence, and reduce maintenance problems;
UNEP-GEF Biosafety team is exploring with different donor governments the possibilities to create regional BCHs;
With Environment Canada’s assistance there is a project under way for the Pacific island countries.

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

66. THANK YOU !