1 OECD 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

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

3 OECD Programmes of work 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

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

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

6 OECD: Structure of the Organisation Numbers of OECD Secretariat staff: Total OECD: approx 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 Role of science in OECD policies “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)

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: Mutagenicity Expert Group on: Reproductive Toxicity Expert Group on: Specific Target Organ Systemic Toxicity Expert Group on: Carcinogenicity Expert Group on: Aquatic Environmental Hazards Expert Group on: Classification Criteria for Mixtures 8 Drafting Groups Expert Group on: Water Activated Toxicity Expert Group on: Aspiration Hazards Expert Group on: Respiratory Tract Irritation

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

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, 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 of MAD

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

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

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

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.

35 WE NEED YOU!!