1. 29 September 2006 | Folie 1 The impact of the OECD on the development of national/international risk/safety assessment frameworks OECD Workshop Beyond the Bluebook, Framework for Risk/Safety Asssessment for Transgenic Plants Jeju Island/Korea, 29 September 2006 Helmut Gaugitsch

2. 29 September 2006 | Folie 2 Topics Intro: The Working Group, The Task Force The G 8 Report International Conferences The major products of OECD on r.a. Relevance to other international Fora (Cartagena, Codex, IPPC etc.) Outlook – Future Directions

3. 29 September 2006 | Folie 3 Relevant OECD Bodies The OECD Working Group on Harmonization of Regulatory Oversight in Biotechnology The OECD Task Force for the Safety of Novel Foods and Feeds

4. 29 September 2006 | Folie 4 The G 8 Report G 8 Summit: Okinawa/Japan, July 2000 OECD study on …implications of biotechnology and other aspects of food safety… Reports from the Working Group and the Task Force Summary of OECD work and approaches to safety in biotechnology (starting with the Blue Book) – Concept of Familiarity, Concept of Substantial Equivalence Starting point for increased international visibility and outreach

5. 29 September 2006 | Folie 5 Post G 8 – International Conferences Increased international activities of OECD Conference New Biotechnology Foods and Crops: Science, Safety & Society, Bangkok, July 2001 International Conference LMOs and the Environment, Raleigh-Durham/USA, November 2001 OECD Workshop on Review of Consensus Documents and Future Work in Harmonization, Washington, October 2003

6. 29 September 2006 | Folie 6 Characteristics and results of these Conferences Broad Participation of IGOs (FAO, Codex, WHO, SCBD) Broad Participation of Stakeholders (government authorities, notifiers, science, NGOs) Outreach: Involvement of Non-Member countries Summary of the state-of-the art concerning risk/safety assessment in biotechnology Strategic, identification of needs and priorities

7. 29 September 2006 | Folie 7 Examples of major Products of OECD The Consensus Documents The OECD Product Database

8. 29 September 2006 | Folie 8 Why Consensus Documents? Recent Compilation: Safety Assessment of Transgenic Organisms, OECD Consensus Documents An Introduction to the Biosafety Consensus Documents of the OECD`s Working Group Baseline scientific knowledge should contribute to a common basis for risk/safety assessment Process: lead country approach, Consultation, outreach to non-member countries, experts driven

9. 29 September 2006 | Folie 9 Consensus Documents Working Group: Biology and Trait - Documents Points to consider document as a standardized structure for biology documents, future review and adaptation Task Force for the Safety of Novel Foods and Feeds – compositional considerations (sugar beet, soybean, maize etc.) Used by applicants and authorities

10. 29 September 2006 | Folie 10 OECD Product Database http://www.oecd.org/biotech/productdatabase Approved Products Key to each product in the database: Unique Identifiers Various types of information available: UI, host organism, introduced trait/genes Currently: system upgrading (change of appearance)

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14. 29 September 2006 | Folie 14 Relevance to other international fora Cartagena Protocol: Interoperability with the Biosafety Clearing House (http://bch.biodiv.org)http://bch.biodiv.org Memorandum of Co-operation with the SCBD Information Elements in Annex III of the Cartagena Protocol Codex Task Force for Biotechnology Risk/safety assessment, comparative assessment based on knowledge Experience with OECD Product Database FAO – IPPC Risk/Safety Assessment

15. 29 September 2006 | Folie 15 Outlook – Future Directions Ensure global usefulness of the work – cooperation and synergies with other IGOs Intensification of Non-Member Countries engagement Address urgent needs and prioritize Improve global information exchange mechanism (Product Database, BCH etc.) Update existing consensus documents, fill remaining gaps, use them nationally and internationally Parameters for environmental risk/safety assessments, implications for national and international risk/safety assessment frameworks, use it in capacity building