OECD Austria Belgium Czech Republic Denmark Finland France Germany (Organisation for Economic Co-Operation and Development) Intergovernmental Organisation grouping 30 industrialised countries EU NAFTA Austria Belgium Czech Republic Denmark Finland France Germany Greece Hungary Ireland Italy Luxembourg The Netherlands Poland Portugal Slovak Republic Spain Sweden United Kingdom Canada Mexico United states ASIA - PACIFIC Australia Japan New Zealand South Korea EUROPEAN NON-EU Iceland Norway Switzerland Turkey 19 European Union member states 4 other European countries the 3 NAFTA countries 4 Asia/Pacific countries

OECD MEMBERSHIP  30 countries European Commission STUCTURE  Council Working Groups Committees Secretariat INSTRUMENTS  Decisions Recommendations

PARTICIPATION IN EHS WORK Members (make decisions) Selected non-member countries Industry Trade Unions Environmental NGOs Animal Welfare NGOs

EHS OBJECTIVES Protect man and environment Efficiency Work sharing; High quality policies and instruments Work sharing; avoid duplication; avoid non-tariff barriers to trade

WORK PROGRAMME Support for (Regulatory) Acceptance of New Instruments (Q)SARs Endocrine Disrupter Testing and Assessment Non-animal methods Formats for Reporting and Evaluation Sustainable Chemistry Mutual Acceptance of Data (including Test Guidelines and Good Laboratory Practice) Assessment and Management of Chemicals (including New and Existing Chemicals)

WORK OF RELEVANCE IN RELATION TO ANIMAL WELFARE Exposure Assessment Global Portal on HPV Chemicals Mutual Acceptance of Data Test Guidelines (in vivo) Test Guidelines (in vitro) (Q)SARs Read-across/category assessment Toxicogenomics

EXPOSURE ASSESSMENT Tools: Guidance documents Emission Scenario Documents Exposure modelling Exposure reporting formats Database on exposure assessment methods Database on use and releases of chemicals Pollutant Release and Transfer Registers (Release Estimation Techniques)

GLOBAL HAZARD DATA PORTAL ON HPV CHEMICALS Globally accessible for free Co-operation with EC, US, Canada, Japan, industry, IPCS Harmonised electronic templates Good overview of available data

MAD Good Laboratory Practice Test Guidelines Mutual Acceptance of Data Principles of Good Laboratory Practice Compliance Monitoring Procedure Mutual Acceptance of Data Avoid: duplication of testing by industry non-tariff trade barriers Saves animals MAD Council Decisions open to non-members

TEST GUIDELINES WORK Updating New Test Guidelines Expert network (6000 experts) Animal welfare issues

TEST GUIDELINES PROGRAMME National co-ordinators Working Group Products: Test Guidelines Detailed Review Documents Guidance Documents

TEST GUIDELINES PROGRAMME EXPERT REVIEW OF DRAFT DOCUMENTS OECD Secretariat’s Document Partner Organisations: EC/ECB ICH IOMC ISO others NGOs: BIAC TUAC ECETOC Croplife ACC COLIPA Civil Society NGO’s ICAPO others National Co-ordinators National Experts Academia Government NGOs Organisation Position Paper National Position Paper (responsibility of the National Co-ordinator) NGO Position Paper This slide is not included to go over all the details, but to show that Test Guidelines development and updating is a transparent process, involving all possible stakeholders (governments, academia, industry, ENGOs). Secretariat

Physical Chemical Properties (21) Effects on Biotic Systems (21) TEST GUIDELINES (1) Physical Chemical Properties (21) Effects on Biotic Systems (21) Degradation and Accumulation (12) Health Effects (48) Existing TG

Process for development and adoption of TGs TEST GUIDELINES (2) Process for development and adoption of TGs MC proposals to National coordinators Meeting (Expert Group agreement) Endorsement by National coordinators Endorsement by Chemicals Committee and by Environment Policy Committee Adoption by OECD Council

TEST GUIDELINES (3) New and updated TG should improve risk management in countries and/or lead to a further reduction of animal use and improvements in animal welfare (widespread support and endorsement of the principle of the 3Rs)

GUIDANCE DOCUMENT 34 Synopsis of the current state of test method validation and guidance on the conduct of validation studies (reliability and relevance). 2 sets of principles: 9 principles for validation (1996) 6 principles for regulatory acceptance (Adopted in 2005)

REGULATORY ACCEPTANCE OF NEW/UPDATED METHODS (1) The test method should have been subjected to a transparent and independent peer review process; demonstrate a linkage between the new test and the existing test method or effects in the target species; provide a comparable or better level of protection

REGULATORY ACCEPTANCE OF NEW/UPDATED METHODS (2) The test method should also be time and cost effective; sufficiently robust (insensitive to minor changes in the protocol); transferable among properly equipped and staffed laboratories.

REGULATORY ACCEPTANCE OF NEW/UPDATED METHODS (3) Furthermore, Adequate test data should be provided for chemicals or products representative of the type of chemicals for which the test is proposed; Justification (scientific, ethical, economic) should be provided for the new method with respect to existing ones.

IN VIVO TESTING/ IN VITRO TESTING Non-animal methods increasingly adopted. For data which are needed to address regulatory requirements but which cannot yet be obtained from in vitro tests, optimisation of use of information from in vivo tests is an effective way to reduce the use of animals.

NEW AND REVISED TEST GUIDELINES (1) Addendum 15, October 2004: 11 TGs and 4 updated TGs, including: 427 Skin Absorption (in vivo) 428 Skin Absorption (in vitro) 430 In vitro Skin Corrosion: Transcutaneous Electrical Resistance Test

NEW AND REVISED TEST GUIDELINES (2) Addendum 15 431 In vitro Skin Corrosion: Human Skin Model Test 432 In vitro Phototoxicity Test

NEXT NEW AND REVISED TEST GUIDELINES Addendum 16 and 17 (to be adopted soon): 10 new or updated TGs, including: Updated TG 425 Up and Down Method TG 435 In Vitro Membrane Barrier Test Method for skin Corrosion

SUMMARY TG’s (1) A large number of projects are underway in the OECD Test Guidelines Programme; These are conducted to meet the regulatory needs of the member countries and to bring a high level of harmonization in testing approaches.

SUMMARY TG’s (2) Alternative test methods are developed as OECD Test Guidelines; All Test Guidelines are now developed with consideration of the 3Rs.

(Q)SARS OECD Principles for validation of (Q)SARs Guidance on Validation Identification of Acceptable (Q)SARs Accessibility of (Q)SAR models (Q)SAR Application Toolbox

READ-ACROSS In HPV chemicals work Categories of chemicals: similar physical chemistry or toxicology due to structural similarity Workshop in 2005 Guidance document Chapter in Manual for Investigating HPV chemicals

TOXICOGENOMICS 2 Workshops with WHO Priorities Category approaches Survey of existing tools Survey of regulatory needs Cross species extrapolation Biomarkers

IATA Toxicogenomics Global Portal Exposure Assessment Toxicogenomics Global Portal Integrated Approaches to Testing and Assessment In vivo Test Guidelines Read-across In vitro Test Guidelines (Q)SARs Mutual Acceptance of Data

SUMMARY Animal welfare issues are very important in OECD work Balance with regulatory needs Many possibilities to address animal welfare Integrated Approach to Testing and Assessment needed OECD looks forward to working with EU on this