OECD

1. What is it Forum for policy dialogue and development based on science and technology Centre for policy research Provider of instruments for harmonisation, co-operation, cost sharing and outreach A “club” of 30 industrialised countries What is it not Provider of technical assistance Supranational ruling body UN Organisation European Organisation Bank OECD

2. OECD(Organisation for Economic Co-operation and Development) InternationalOrganisation grouping 30 industrialised countries: Australia Austria Belgium Canada Czech Republic Denmark Finland France Germany Greece Hungary Iceland Ireland Italy Japan Luxembourg Mexico The Netherlands New Zealand Norway Poland Portugal Slovak Republic South Korea Spain Sweden Switzerland Turkey United Kingdom United States

3. economic policy; education, employment, labour and social affairs; energy; environment; financial, fiscal and enterprise affairs; food, agriculture and fisheries; international trade; public management; science, technology and industry; statistics; territorial development; development cooperation OECD Programmes of work

4. OECD: Structure of the Organisation (1) Member Countries’ Governments Council of Ambassadors to OECD Government Representatives to Chemicals Programme Environmental Policy Committee (EPOC) Joint Meeting

5. Joint Meeting Working Party on Chemicals,Pesticides and Biotechnology Chemicals Committee OECD: Structure of the Organisation (2) • 5 Task Forces: • HCL • Existing Chemicals • New Chemicals • PRTR • Novel Foods and Feeds Safety • 5 Working Groups: • Test Guidelines Programme • Chemical Accidents • Pesticides • Biotechnology • GLP

6. OECD: Structure of the Organisation Numbers of OECD Secretariat staff: • Total OECD: approx. 2000 • Environment Directorate: approx. 100 • EHS Division (9 Programmes): approx. 28 • Test Guideline Programme: approx. 8 OECD offices: • Paris (Headquarters) • Bonn, Mexico City, Tokyo, Washington (publication centers).

7. Environment, Health and Safety Division Objectives and Activities Protect Man and Environment Efficiency • Share the Burden; • Co-ordination; • Avoid duplication; • Avoid non-tariff barriers to trade • High Quality Instruments; • Outreach; • Harmonisation

8. Sharing the Burden • Investigating High Production Volume Chemicals • Hazard/Risk Assessment Methods • Pesticide (Re-) registration • Risk Reduction • Information Exchange

9. Co-ordination • Risk Management • Capacity Building • Endocrine Disruptors • PRTR

10. Outreach • Transfer of Expertise • Transfer of Policy Experience • Formal Co-operation - MAD

11. Role of science in OECD policies • All OECD agreements, policies and other products are developed by consensus; • Scientific or technical agreement is the first step in the processes leading to OECD’s policy decisions: “Science rules, policy rules” • Some examples of the work in practice…

12. “De-coupling environmental issues from economic growth” (Environmental strategy for the first decade of the 21st century, May 2001) “Economic growth is key to environmental progress” (President George W. Bush, 15 February 2002) Role of science in OECD policies

13. GHS:Globally Harmonised System for Classification and Labelling of Chemicals and Chemical Mixtures

14. What is the GHS? • A common and coherent approach to defining and classifying hazards, and communicating information on labels and safety data sheets; • Target audiences include workers, consumers, transport workers, and emergency responders; • Provides the underlying infrastructure for establishment of national, comprehensive chemical safety programs.

15. GHS:Globally Harmonised System for Classification and Labelling of Chemicals and Chemical Mixtures • 1. Hazard Classification of Substances • Human Health Hazards (9 classes) • Hazards to the Environment (1 class) • Physical/Chemical Hazards (10 classes) • 2. Hazard Classification of Mixtures • Human Health Hazards (7 classes) • Hazards to the Environment (1 class) • 3. Hazard Communication • Label elements • Safety Data Sheets

16. Step 1 Detailed Review Document (DRD) a) Overview of available classification systems in a given area b) Thorough analysis, including the scientific basis of each system Step 2 Proposal for a harmonized classification system, leaving options for discussion; agreement of the Expert Group Step 3 Discussion of the proposed harmonized classification system by the Task Force; reaching consensus and approval of the proposal Sequential Approach - The Process of Harmonisation of Classification Systems

17. Policy and Expert Groups of the Harmonisation of Classification and Labelling Project Task Force on Harmonisation of Classification and Labelling (TF-HCL) Expert Group on:Acute Toxicity Expert Group on:Specific Target Organ Systemic Toxicity Expert Group on:Water Activated Toxicity Expert Group on:Mutagenicity Expert Group on:Carcinogenicity Expert Group on:Aspiration Hazards Expert Group on:Reproductive Toxicity Expert Group on:Aquatic Environmental Hazards Expert Group on:Respiratory Tract Irritation Expert Group on:Classification Criteria for Mixtures 8 Drafting Groups

18. Step 4 Step 5 Endorsement of the proposed harmonized classification system by OECD Member countries at the Joint Meeting (Policy decision) Acceptance via IOMC by UN ECOSOC (Sub)Committee on GHS for inclusion in GHS Sequential Approach - The Process of Harmonisation of Classification Systems

19. The long and winding road to scientific consensus Example: aquatic environmental hazards (1): • Two separate Expert Groups, later combined (total of approx. 60 experts); • Work started in February 1995 and finished in June 2001; • 10 face-to-face meetings, 50-60 teleconferences;

20. The long and winding road to scientific consensus Example: aquatic environmental hazards (2): • Achievements: • Harmonised classification systems for chemical substances and mixtures; • Comprehensive Guidance Document on the use of the classification system for aquatic environmental hazards; • Guidance Document for the conduct of the Transformation/Dissolution protocol for metal compounds.

21. The development of OECD Test Guidelines as standard reference tools for chemical testing. The story ofMAD

22. “Decides that data generated in the testing of chemicals in an OECD Member country in accordance with OECD Test Guidelines and OECD Principles of Good Laboratory Practice shall be accepted in other Member countries for purposes of assessment and other uses relating to the protection of man and the environment.” 1981 OECD Council Decision on the Mutual Acceptance of Data For Assessment of Chemicals

23. MAD and Non-Member Countries • Accept data from OECD countries (GLP, TG) • Assistance in developing compliance system • Participate in OECD work • OECD countries accept data from non-OECD countries (GLP, TG) • International standard open to all interested WTO members

24. Procedure for the development of an OECD Test Guideline (1): • Submission of the proposal to develop a Test Guideline; • Completion of the Standard Project Submission Form (SPSF); • Priority setting by National Co-ordinators; • Start of the project;

25. Procedure for the development of an OECD Test Guideline (2) • Establishment of ad hoc Expert Group; • Consider details of the method and validation status; • Review of the draft guideline proposal; • Analysis of comments; • Expert meeting(s);

26. Physical-Chemical Properties Aquatic Ecotoxicity TerrestrialEcotoxicity Abiotic Degradation Biodegradation Bioaccumulation Health Effects Exposure Data Analysis Animal Welfare Subject Areas For Which Member Countries Have Nominated National Experts • Total number of Experts in the data base: 6,000

27. Test Guidelines ProgrammeExpert Review Of Draft Documents OECD Secretariat’s Document • Partner Organisations: • EC/ECB • ICH • IOMC • ISO • others National Co-ordinators • Industry Organisations: • BIAC • ECETOC • GIFAP • CMA • COLIPA • others Academia Government Industry National Position Paper (responsibility of the National Co-ordinator) Organisation’s Position Paper Industry’s Position Paper Secretariat

28. Procedure for the development of an OECD Test Guideline (3): • Review of the revised guideline proposal; • Approval of the draft Test Guideline by WNT; • Endorsement at policy level; • Adoption by Council; • Publication as Addendum to Council Decision C(81)30(Final).

29. Secretariat Member Countries TUAC SPSF Essential Criteria Desirable Criteria WNT Small ad hoc Expert Group Proposal for Test Guideline (TG) Development BIAC NGOs Revised Draft TG Proposal Int’l Orgs. Int’l Sci. Societies Draft Proposal for TG WNT Final TG Proposal Meetings Commenting Round(s) Publication JM EPOC Council Final Test Guideline Implementation OECD Test Guideline Development Process

30. Genetically Modified Foods and Feeds (GMFs) (or Products of Modern Biotechnology) and the Precautionary Principle Where science and policy are intertwined…

31. GMF’s and Precaution The safety of genetically modified foods/feeds: • “Precautionary Principle”: concept description appreciated by a number of countries as appropriate, by others as too strongly science-driven; • “Precautionary Approach”: concept description appreciated by all.

32. GMF’s and Precaution Precautionary Approach interpreted as: • In case of lack of scientific certainty: use of the is not allowed; more data should be generated; or: • In case of lack of scientific certainty: adjust (increase) the safety/uncertainty factor(s), allow use of the GMF and develop more data.

33. GMF’s and Precaution Arguments heard: • “Lack of scientific certainty” is not defined; requiring more data could be used as a tool to control/avoid the import of GMF containing foods/feeds: non-tariff trade barrier. • Increasing the safety factor does not make up for insufficient data: there could be a long term major environmental/health effect.

34. GMF’s and Precaution • Member countries have not been able to reach consensus on data requirements for GMF’s; • Focus in OECD is on science-based “Consensus Documents” on specific novel foods/feeds that can be used for national regulatory assessments.

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