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Austria Belgium Czech Republic Denmark Finland France Germany Greece Hungary Ireland Italy Luxembourg The Netherlands
Poland Portugal Slovak Republic Spain Sweden United Kingdom
(Organisation for Economic Co-Operation and Development)Intergovernmental Organisation grouping 30 industrialised countries
Canada Mexico United states
OECD
EU NAFTA
EUROPEAN NON-EU
Iceland Norway Switzerland Turkey
ASIA - PACIFIC
Australia Japan New Zealand South Korea
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OECD
MEMBERSHIP 30 countriesEuropean Commission
STUCTURE CouncilWorking GroupsCommitteesSecretariat
INSTRUMENTS DecisionsRecommendations
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PARTICIPATION IN EHS WORK
Members (make decisions) Selected non-member countries Industry Trade Unions Environmental NGOs Animal Welfare NGOs
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EHS OBJECTIVES
Protect man and environment
Efficiency
High quality policies and instruments
Work sharing;avoid duplication;
avoid non-tariff barriersto trade
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WORK PROGRAMME
I. Support for (Regulatory) Acceptance of New InstrumentsI. (Q)SARs
II. Endocrine Disrupter Testing and Assessment
III. Non-animal methods
IV. Formats for Reporting and Evaluation
V. Sustainable Chemistry
II. Mutual Acceptance of Data (including Test Guidelines and Good Laboratory Practice)
III. Assessment and Management of Chemicals (including New and Existing Chemicals)
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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
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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)
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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
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MAD
Avoid: duplication of testing by industry non-tariff trade barriers
Saves animals
MAD Council Decisions open to non-members
Good Laboratory Practice-Principles of Good Laboratory Practice-Compliance Monitoring Procedure
Test Guidelines
Mutual Acceptance of Data
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TEST GUIDELINES WORK
Updating
New Test Guidelines
Expert network (6000 experts)
Animal welfare issues
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TEST GUIDELINES PROGRAMME
National co-ordinators Working Group
Products:
Test Guidelines Detailed Review Documents Guidance Documents
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NationalCo-ordinators
National Experts
Academia Government NGOs
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
NationalPosition Paper
(responsibility of theNational Co-ordinator)
OrganisationPosition Paper
NGOPosition Paper
Secretariat
TEST GUIDELINES PROGRAMMEEXPERT REVIEW OF DRAFT DOCUMENTS
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TEST GUIDELINES (1)
Physical Chemical Properties (21)
Effects on Biotic Systems (21)
Degradation and Accumulation (12)
Health Effects (48)
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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
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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)
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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)
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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
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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.
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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.
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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.
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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
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NEW AND REVISED TEST GUIDELINES (2)
Addendum 15
431 In vitro Skin Corrosion: Human Skin Model Test
432 In vitro Phototoxicity Test
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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
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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.
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SUMMARY TG’s (2)
Alternative test methods are developed as OECD Test Guidelines;
All Test Guidelines are now developed with consideration of the 3Rs.
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(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
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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
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TOXICOGENOMICS
2 Workshops with WHO
Priorities Category approaches Survey of existing tools Survey of regulatory needs Cross species extrapolation Biomarkers
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IATA
Exposure Assessment
Mutual Acceptance
of Data
In vivo Test Guidelines
In vitro Test Guidelines
Global Portal
(Q)SARs
Read-across
Toxicogenomics
Integrated Approaches to
Testing and Assessment
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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