The Role of OECD in Achieving International Acceptance of Harmonized Test Guidelines Herman B.W.M. Koëter Former Principal Administrator OECD Environment, Health and Safety Division 2, rue André Pascal Paris, France Tel: / Fax:

List of abbreviations and acronyms ACPAAmerican Crop Protection Association BIACBusiness and Industry Advisory Council COLIPAEuropean Cosmetics, Toiletry and Perfumery Association ECEuropean Commission ECBEuropean Chemicals Bureau ECETOCEuropean Centre for Ecotoxicology and Toxicology of Chemicals ECPAEuropean Crop Protection Association ECVAMEuropean Centre for the Validation of Alternative Methods EDEndocrine Disrupter EDTAEndocrine Disrupters Testing and Assessment EPAEnvironmental Protection Agency

EPOCEnvironmental Policy Committee HTPSHigh Through Put Pre Screen ICHInternational Conference on Harmonisation of Chemicals ICCVAMInteragency Co-ordinating Committee for the Validation of Alternative Methods IFCSIntergovernmental Forum on Chemical Safety IOMCInterOrganisation Programme on the Sound Management of Chemicals ISOInternational Standard Organisation MADMutual Acceptance of Data OECDOrganisation for Economic Co-operation and Development SPSFStandard Project Submission Form

TGTest Guideline TUACTrade Union Advisory Committee VMG-ecoValidation Management Group for ecotoxicity tests VMG-mammalian Validation Management Group for mammalian toxicity tests WNTWorking Group of National Co-ordinators of the Test Guidelines Programme

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

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

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, ,700 7,500 3,300 (millions of products) /year (1,000 in US) (21,000 products) (40,000 products)

ACCEPTABLE RISKS

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

“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

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 MAD and Non-Member Countries

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

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

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

Procedure for the Development of OECD Test Guidelines 2. Completion of the Standard Project Submission Form (SPSF): Essential Criteria Desirable Criteria

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

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

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

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

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

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

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

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

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

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

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

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

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 Revised Draft TG Proposal Final TG Proposal WNT JMEPOCCouncil Final Test Guideline Implementation Publication OECD Test Guideline Development Process Small ad hoc Expert Group SPSF Essential Criteria Desirable Criteria Commenting Round(s)

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;

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

THE WORK OF OECD ON TESTING AND ASSESSMENT OF ENDOCRINE DISRUPTERS

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. IFCS II (February 1997) recommended that IOMC should:

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

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

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

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.

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.

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.

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

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.

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). New Tools Needed

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