The Impact of OECD on Risk/Safety Assessment Frameworks: Workshop Insights

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. 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. 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. 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. 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. 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. Examples of major „Products“ of OECD • The Consensus Documents • The OECD Product Database

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. 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. 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)

14. Relevance to other international fora • Cartagena Protocol: • Interoperability with the Biosafety Clearing House (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. 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