The Role of OECD in Achieving International

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The Role of OECD in Achieving International Accept
ance of Harmonized Test Guidelines Herman B.W.M.
KoëterFormer Principal AdministratorOECD
Environment, Health and Safety Division2, rue
André Pascal75775 Paris, FranceTel
33.1.45.24.98.44/33.1.45.24.16.74Fax33.1.45.2
4.16.75 e-mail env.tgcontact_at_oecd.org
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List of abbreviations and acronymsACPA American
Crop Protection AssociationBIAC Business and
Industry Advisory CouncilCOLIPA European
Cosmetics, Toiletry and Perfumery
AssociationEC European Commission ECB European
Chemicals BureauECETOC European Centre for
Ecotoxicology and Toxicology of
ChemicalsECPA European Crop Protection
AssociationECVAM European Centre for the
Validation of Alternative MethodsED Endocrine
DisrupterEDTA Endocrine Disrupters Testing and
AssessmentEPA Environmental Protection
Agency
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EPOC Environmental Policy CommitteeHTPS High
Through Put Pre ScreenICH International
Conference on Harmonisation of
Chemicals ICCVAM Interagency Co-ordinating
Committee for the Validation of Alternative
MethodsIFCS Intergovernmental Forum on Chemical
SafetyIOMC InterOrganisation Programme on
the Sound Management of ChemicalsISO Internat
ional Standard OrganisationMAD Mutual
Acceptance of DataOECD Organisation for
Economic Co-operation and DevelopmentSPSF Stan
dard Project Submission Form
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TG Test GuidelineTUAC Trade Union Advisory
CommitteeVMG-eco Validation Management Group for
ecotoxicity testsVMG-mammalian Validation
Management Group for mammalian toxicity tests
WNT Working Group of National Co-ordinators
of the Test Guidelines Programme
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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 Mex
ico The Netherlands New Zealand Norway
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Objectives
Protect Man and Environment
Efficiency
High Quality Instruments

• Share the Burden
• Avoid duplication
• Avoid non-tariff barriers to trade

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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 2,000 600 8,700 7,500 3,30
0
(millions of products) /year (1,000 in
US) (21,000 products) (40,000 products)
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ACCEPTABLE RISKS
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Data Quality Ensured By
Test Guidelines
Good Laboratory Practice
Mutual Acceptance of Data MAD Council Decision
open to non-members
Avoid duplication of testing by
industry non-tariff trade barriers
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1981 OECD Council Decision on the Mutual
Acceptance of Data For Assessment of Chemicals

• 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.

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MAD and Non-Member Countries
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
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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

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OECD Test Guideline Development Process
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Procedure for the Development of OECD Test
Guidelines

• 1. Submission of the proposal by
• Member country
• BIAC
• TUAC
• International Scientific Society
• Secretariat

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Procedure for the Development of OECD Test
Guidelines

• 2. Completion of the Standard Project Submission
  Form (SPSF)
• http//www.oecd.org/ehs/test
• Essential Criteria
• Desirable Criteria

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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

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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

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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 documentsessential or helpful
• For guidance documents linked to a specific TG
  or for general guidance

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Procedure for the Development of OECD Test
Guidelines

• 3. Priority Setting by National Co-ordinators
• By written procedure
• High,Medium,Low ranking priorities
• Proposal for the Annual Workplan
• Endorsement by Joint Meeting

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OECD Test Guideline Development Process
Secretariat
Member Countries
TUAC
SPSF Essential Criteria Desirable Criteria
WNT
Small ad hoc Expert Group
Proposal for Test Guideline (TG) Development
BIAC
NGOs
Revised Draft TG Proposal
Intl Orgs.
Intl Sci. Societies
Revised Draft TG Proposal
Final TG Proposal
WNT
Meetings
Commenting Round(s)
JM
EPOC
Council
Publication
Final Test Guideline
Implementation
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Procedure for the Development of OECD Test
Guidelines

• Establishment of ad hoc Expert Group
• Draft Guideline
• Circulation for Expert Review

4. Start of the Project
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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

Total number of Experts in the data base 6,000
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Test Guidelines Programme
WNT

• Expert Groups
• Algae
• Lemna
• Terrestrial effects
• Statisitics
• Biocides release
• Repro tox
• Neuro tox
• etc.

EDTA
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Test Guidelines ProgrammeExpert Review Of Draft
Documents
OECD Secretariats Document

• Partner Organisations
• EC/ECB
• ICH
• IOMC
• ISO
• others

National Co-ordinators

• Industry Organisations
• BIAC
• ECETOC
• GIFAP
• CMA
• COLIPA
• others

Academia Government Industry
National Position Paper (responsibility of
the National Co-ordinator)
Organisations Position Paper
Industrys Position Paper
Secretariat
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Procedure for the Development of OECD Test
Guidelines
5. Analysis of Comments

• National Positions
• Revision of the Proposal
• Justification for the Changes
• Circulation for Expert Review

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Procedure for the Development of OECD Test
Guidelines

• Secretariat Involvement
• Workshop
• ad hoc Expert Group Meeting
• Nominated Expert Meeting

6. Arranging for Expert Meeting
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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

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

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Guidance Document on the Recognition, Assessment,
and Use of Clinical Signs as Humane Endpoints
for Experimental Animals Used in Safety
Evaluation
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THE WORK OF OECD ON TESTING AND ASSESSMENT OF
ENDOCRINE DISRUPTERS
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IFCS II (February 1997) recommended that IOMC
should
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.
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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

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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

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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

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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.

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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.

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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.

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Sharing the Burden of Testing and Assessment

• Sharing Test Results
• High throughput pre-screens (HTPS) (Japan and
  USA)
• One-generation studies with 10-12 substances
  (Japan)
• Reproductive Toxicity Screens for 1000-2000 HPV
  Chemicals (USA)
• Assessment of approx. 70 chemicals in the content
  of the Childrens Health Programme (USA).

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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.

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New Tools Needed

• 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).

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For Further Information on OECDEnvironment,
Health and Safety Division

• http//www1.oecd.org/ehs
• http//www1.oecd.org/ehs/test
• http//www1.oecd.org/ehs/endocrin/EDTA1.htm
• http//www1.oecd.org/ehs/class

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WE NEED YOU!!