Presentation on theme: "OECD Austria Belgium Czech Republic Denmark Finland France Germany"— Presentation transcript:
1OECD Austria Belgium Czech Republic Denmark Finland France Germany (Organisation for Economic Co-Operation and Development) Intergovernmental Organisation grouping 30 industrialised countriesEUNAFTAAustriaBelgiumCzech RepublicDenmarkFinlandFranceGermanyGreeceHungaryIrelandItalyLuxembourgThe NetherlandsPolandPortugalSlovak RepublicSpainSwedenUnited KingdomCanadaMexicoUnited statesASIA - PACIFICAustraliaJapanNew ZealandSouth KoreaEUROPEAN NON-EUIcelandNorwaySwitzerlandTurkey19 European Union member states4 other European countriesthe 3 NAFTA countries4 Asia/Pacific countries
2OECD MEMBERSHIP 30 countries European Commission STUCTURE Council Working GroupsCommitteesSecretariatINSTRUMENTS DecisionsRecommendations
3PARTICIPATION IN EHS WORK Members (make decisions)Selected non-member countriesIndustryTrade UnionsEnvironmental NGOsAnimal Welfare NGOs
4EHS OBJECTIVES Protect man and environment Efficiency Work sharing; High quality policies and instrumentsWork sharing;avoid duplication; avoid non-tariff barriers to trade
5WORK PROGRAMME Support for (Regulatory) Acceptance of New Instruments (Q)SARsEndocrine Disrupter Testing and AssessmentNon-animal methodsFormats for Reporting and EvaluationSustainable ChemistryMutual Acceptance of Data(including Test Guidelines and Good Laboratory Practice)Assessment and Management of Chemicals (including New and Existing Chemicals)
6WORK OF RELEVANCE IN RELATION TO ANIMAL WELFARE Exposure AssessmentGlobal Portal on HPV ChemicalsMutual Acceptance of DataTest Guidelines (in vivo)Test Guidelines (in vitro)(Q)SARsRead-across/category assessmentToxicogenomics
7EXPOSURE ASSESSMENT Tools: Guidance documents Emission Scenario DocumentsExposure modellingExposure reporting formatsDatabase on exposure assessment methodsDatabase on use and releases of chemicalsPollutant Release and Transfer Registers(Release Estimation Techniques)
8GLOBAL HAZARD DATA PORTAL ON HPV CHEMICALS Globally accessible for freeCo-operation with EC, US, Canada, Japan, industry, IPCSHarmonised electronic templatesGood overview of available data
9MAD Good Laboratory Practice Test Guidelines Mutual Acceptance of Data Principles of Good Laboratory PracticeCompliance Monitoring ProcedureMutual Acceptance of DataAvoid: duplication of testing by industry non-tariff trade barriersSaves animalsMAD Council Decisions open to non-members
10TEST GUIDELINES WORK Updating New Test Guidelines Expert network (6000 experts)Animal welfare issues
11TEST GUIDELINES PROGRAMME National co-ordinatorsWorking GroupProducts:Test GuidelinesDetailed Review DocumentsGuidance Documents
12TEST GUIDELINES PROGRAMME EXPERT REVIEW OF DRAFT DOCUMENTS OECD Secretariat’s DocumentPartner Organisations:EC/ECBICHIOMCISOothersNGOs:BIACTUACECETOCCroplifeACCCOLIPACivil Society NGO’sICAPOothersNationalCo-ordinatorsNational ExpertsAcademia Government NGOsOrganisationPosition PaperNationalPosition Paper(responsibility of theNational Co-ordinator)NGOPosition PaperThis slide is not included to go over allthe details, but to show that TestGuidelines development and updatingis a transparent process, involving allpossible stakeholders (governments,academia, industry, ENGOs).Secretariat
13Physical 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
14Process for development and adoption of TGs TEST GUIDELINES (2)Process for development and adoption of TGsMC proposals to National coordinators Meeting(Expert Group agreement)Endorsement by National coordinatorsEndorsement by Chemicals Committee and by Environment Policy CommitteeAdoption by OECD Council
15TEST GUIDELINES (3) New and updated TG should improve risk management in countries and/orlead to a further reduction of animal use and improvements in animal welfare (widespread support and endorsement of the principle of the 3Rs)
16GUIDANCE 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)
17REGULATORY ACCEPTANCE OF NEW/UPDATED METHODS (1) The test method shouldhave 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
18REGULATORY ACCEPTANCE OF NEW/UPDATED METHODS (2) The test method should alsobe time and cost effective;sufficiently robust (insensitive to minor changes in the protocol);transferable among properly equipped and staffed laboratories.
19REGULATORY 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.
20IN 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.
21NEW 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
22NEW AND REVISED TEST GUIDELINES (2) Addendum 15431 In vitro Skin Corrosion: Human Skin Model Test432 In vitro Phototoxicity Test
23NEXT 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 MethodTG 435 In Vitro Membrane Barrier Test Method for skin Corrosion
24SUMMARY 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.
25SUMMARY TG’s (2)Alternative test methods are developed as OECD Test Guidelines;All Test Guidelines are now developed with consideration of the 3Rs.
26(Q)SARS OECD Principles for validation of (Q)SARs Guidance on ValidationIdentification of Acceptable (Q)SARsAccessibility of (Q)SAR models(Q)SAR Application Toolbox
27READ-ACROSSIn HPV chemicals workCategories of chemicals: similar physical chemistry or toxicology due to structural similarityWorkshop in 2005Guidance documentChapter in Manual for Investigating HPV chemicals
28TOXICOGENOMICS 2 Workshops with WHO Priorities Category approaches Survey of existing toolsSurvey of regulatory needsCross species extrapolationBiomarkers
29IATA Toxicogenomics Global Portal Exposure AssessmentToxicogenomicsGlobal PortalIntegrated Approaches to Testing and AssessmentIn vivo Test GuidelinesRead-acrossIn vitro Test Guidelines(Q)SARsMutual Acceptance of Data
30SUMMARY Animal welfare issues are very important in OECD work Balance with regulatory needsMany possibilities to address animal welfareIntegrated Approach to Testing and Assessment neededOECD looks forward to working with EU on this