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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