The Role of OECD in Achieving International Acceptance of Harmonized Test Guidelines

1. The Role of OECD in Achieving International Acceptance of Harmonized Test Guidelines Herman B.W.M. KoëterFormer Principal AdministratorOECD Environment, Health and Safety Division2, rue André Pascal75775 Paris, FranceTel: +33.1.45.24.98.44/+33.1.45.24.16.74Fax:+33.1.45.24.16.75 e-mail : env.tgcontact@oecd.org

2. List of abbreviations and acronymsACPA American Crop Protection AssociationBIAC Business and Industry Advisory CouncilCOLIPA European Cosmetics, Toiletry and Perfumery AssociationEC European Commission ECB European Chemicals BureauECETOC European Centre for Ecotoxicology and Toxicology of ChemicalsECPA European Crop Protection AssociationECVAM European Centre for the Validation of Alternative MethodsED Endocrine DisrupterEDTA Endocrine Disrupters Testing and AssessmentEPA Environmental Protection Agency

3. EPOC Environmental Policy CommitteeHTPS High Through Put Pre ScreenICH International Conference on Harmonisation of Chemicals ICCVAM Interagency Co-ordinating Committee for the Validation of Alternative MethodsIFCS Intergovernmental Forum on Chemical SafetyIOMC InterOrganisation Programme on the Sound Management of ChemicalsISO International Standard OrganisationMAD Mutual Acceptance of DataOECD Organisation for Economic Co-operation and DevelopmentSPSF Standard Project Submission Form

4. TG Test GuidelineTUAC Trade Union Advisory CommitteeVMG-eco Validation Management Group for ecotoxicity testsVMG-mammalian Validation Management Group for mammalian toxicity tests WNT Working Group of National Co-ordinators of the Test Guidelines Programme

5. 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

6. Objectives Protect Man and Environment Efficiency High Quality Instruments • Share the Burden; • Avoid duplication; • Avoid non-tariff barriers to trade

7. Estimated Numbers of Chemicals(EPA estimations, 1995) • Number of Chemicals: • Chemicals in Commerce: • Industrial Chemicals: • New Chemicals: • Pesticides: • Food Additives: • Cosmetic Ingredients: • Human Pharmaceuticals: 5,000,000 80,000 72,000 2,000 600 8,700 7,500 3,300 (millions of products) /year (1,000 in US) (21,000 products) (40,000 products)

8. ACCEPTABLE RISKS

9. Data Quality Ensured By: Test Guidelines Good Laboratory Practice Mutual Acceptance of Data MAD Council Decision open to non-members Avoid: duplication of testing by industry non-tariff trade barriers

10. “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

11. 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) MAD: international standard open to all interested WTO members

12. Publication Of OECD Test Guidelines • Original publication in 1981: 51 Guidelines • 13 Addenda • 100+ new/updated Guidelines • Detailed Review Documents • Guidance documents, available as: • Hard copy (loose-leaf) • CD-ROM • On-line (OECD Bookshop) • Draft Guidelines and Guidance Documents available on the internet

13. 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

14. Procedure for the Development of OECD Test Guidelines • 1. Submission of the proposal by: • Member country • BIAC • TUAC • International Scientific Society • Secretariat

15. Procedure for the Development of OECD Test Guidelines • 2. Completion of the Standard Project Submission Form (SPSF): • http://www.oecd.org/ehs/test • Essential Criteria • Desirable Criteria

16. Procedure for the Development of OECD Test Guidelines • Essential Criteria to be met before considering a proposal: • Regulatory need/Data requirement • Contributes to the International Harmonisation of Hazard/ Risk Assessment • Addresses a health or environmental concern • Considerable support from Member countries • Lead country/Stakeholder identified

17. Procedure for the Development of OECD Test Guidelines • Desirable Criteria to be met before considering a Proposal: • Guideline intended for general/broad use • Scientifically valid, reliable, relevant • Addresses endpoints not yet covered • Existing national/regional protocols as a basis

18. Procedure for the Development of OECD Test Guidelines (2) • Desirable Criteria to be met before considering a Proposal: • Animal welfare concerns are addressed • Contributes to saving resources • For guidance documents:essential or helpful • For guidance documents: linked to a specific TG or for general guidance

19. Procedure for the Development of OECD Test Guidelines • 3. Priority Setting by National Co-ordinators • By written procedure • High,Medium,Low ranking priorities • Proposal for the Annual Workplan • Endorsement by Joint Meeting

20. OECD Test Guideline Development Process 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 Revised Draft TG Proposal WNT Final TG Proposal Meetings Commenting Round(s) JM EPOC Council Publication Final Test Guideline Implementation

21. Procedure for the Development of OECD Test Guidelines 4. Start of the Project • Establishment of ad hoc Expert Group • Draft Guideline • Circulation for Expert Review

22. 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

23. VMG - mammalian VMG - eco Test Guidelines Programme WNT • Expert Groups • Algae; • Lemna; • Terrestrial effects; • Statisitics; • Biocides release; • Repro tox; • Neuro tox; • etc. EDTA

24. 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

25. Procedure for the Development of OECD Test Guidelines 5. Analysis of Comments • National Positions • Revision of the Proposal • Justification for the Changes • Circulation for Expert Review

26. Procedure for the Development of OECD Test Guidelines • Secretariat Involvement • Workshop • ad hoc Expert Group Meeting • Nominated Expert Meeting 6. Arranging for Expert Meeting

27. Procedure for the Development of OECD Test Guidelines • Reaching scientific consensus • Approval by National co-ordinators • Endorsement by Joint Meeting • EPOC Approval for Submission to Council • Council Endorsement 7. Adoption of new Guideline

28. OECD Test Guideline Development Process 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) Final Test Guideline Publication JM EPOC Council Implementation

29. Chemicals Programme and Animal Welfare Objectives: • Develop alternative methods to animal tests for regulatory hazard assessment; • Revise, as appropriate, existing animal tests to accommodate animal welfare to the extent possible; • Develop Guidance Documents on animal welfare issues, as appropriate;

30. Guidance Document on the Recognition, Assessment, and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation

31. THE WORK OF OECD ON TESTING AND ASSESSMENT OF ENDOCRINE DISRUPTERS

32. IFCS II (February 1997) recommended that IOMC should: A. Compile and harmonise definitions and terms; B. Promote coordinated research, identify gaps and priorities; C. Identify testing priorities, gaps, develop and harmonise testing guidelines; D. Adopt and maintain an inventory of research activities; E. Facilitate information exchange.

33. Task Force on Endocrine Disrupters Testing and Assessment (EDTA) Tasks: • Enhancements and modifications of existing Test Guidelines; • Development of new Test Guidelines; • Management of validation work, as appropriate; • Development of harmonised strategy for the screening and testing of endocrine disrupters; • Sharing testing and assessments

34. Endocrine Disrupters Testing and Assessment Development of new test methods: • Uterotrophic assay • Hershberger assay • Fish screening tests (3 tests) • Fish full life cycle test • Amphibian screening and testing methods

35. Endocrine Disrupters Testing and Assessment Revision of existing test methods: • TG 407: 4-week systemic toxicity study, • TG 416: 2-generation reproduction study, • TG 206: avian reproduction study

36. Validation Work • Criteria and Principles based in ICCVAM ECVAM and OECD Solna principles; • Flexibility and transparency important; • Management Committees to be established for mammalian ecotoxicology testing.

37. Sharing the Burden of Testing and Assessment • Vast number of chemicals; • Number of screens/tests for each chemical; • Time pressure; • Costs of testing are very high; • Different philosophies in Member countries; • Grouping of Chemicals; • Tools for Screening and Testing; • Co-ordination of Testing; • Hazard Assessment.

38. Sharing the Burden of Testing and Assessment • Grouping of chemicals; • Tools for Screening and Testing; • Co-ordination of Testing; • Sharing Test Results; • Sharing Hazard/Risk Assessment Reports.

39. Sharing the Burden of Testing and Assessment Sharing Test Results: • High throughput pre-screens (HTPS) (Japan and USA); • One-generation studies with 10-12 substances (Japan); • Reproductive Toxicity Screens for 1000-2000 HPV Chemicals (USA); • Assessment of approx. 70 chemicals in the content of the Children’s Health Programme (USA).

40. Sharing the Burden of Testing and Assessment Sharing Hazard/Risk Assessment Reports: • Differences in assessment approaches; • Underlying science and principles; • Exchange information on emerging scientific developments; • Agreement on essential elements of E.D. assessment reports; • Develop generic guidance for the assessment of EDs; • Sharing existing hazard/risk assessment reports.

41. New Tools Needed • Collection and generation of data (e.g., release estimation methodologies; product registers) and also; • Risk assessments (e.g., life cycle assessment; toxicogenomics/proteomics, transgenic animals); • Risk management (e.g., sustainable chemistry; green procurement; socio-economic analysis).

42. For Further Information on OECDEnvironment, Health and Safety Division: • http://www1.oecd.org/ehs • http://www1.oecd.org/ehs/test • http://www1.oecd.org/ehs/endocrin/EDTA1.htm • http://www1.oecd.org/ehs/class

43. WE NEED YOU!!