29 september 2006 | folie 1 the impact of the oecd on the development of national/international...
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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
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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
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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
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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
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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
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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
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Examples of major „Products“ of OECD
The Consensus Documents The OECD Product Database
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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
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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
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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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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
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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