1. 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

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

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

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

5. 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)

6. 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

7. 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)

8. 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

9. 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

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

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

12. 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

13. 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

14. 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

15. 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)

16. 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)

17. 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

18. 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.

19. 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.

20. 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.

21. 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

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

23. 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

24. 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.

25. SUMMARY 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 Validation
Identification of Acceptable (Q)SARs
Accessibility of (Q)SAR models
(Q)SAR Application Toolbox

27. 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

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

29. 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

30. 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