slide1 n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
The Role of OECD in Achieving International Acceptance of Harmonized Test Guidelines PowerPoint Presentation
Download Presentation
The Role of OECD in Achieving International Acceptance of Harmonized Test Guidelines

Loading in 2 Seconds...

play fullscreen
1 / 43

The Role of OECD in Achieving International Acceptance of Harmonized Test Guidelines - PowerPoint PPT Presentation


  • 127 Views
  • Uploaded on

The Role of OECD in Achieving International Acceptance of Harmonized Test Guidelines Herman B.W.M. Koëter Former Principal Administrator OECD Environment, Health and Safety Division 2, rue André Pascal 75775 Paris, France Tel: +33.1.45.24.98.44/+33.1.45.24.16.74 Fax:+33.1.45.24.16.75

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

The Role of OECD in Achieving International Acceptance of Harmonized Test Guidelines


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
slide1

The Role of OECD in Achieving International

Acceptance 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/+33.1.45.24.16.74Fax:+33.1.45.24.16.75

e-mail : env.tgcontact@oecd.org

slide2

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

slide3

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 International Standard OrganisationMAD Mutual Acceptance of DataOECD Organisation for Economic Co-operation and DevelopmentSPSF Standard Project Submission Form

slide4

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

slide5

OECD(Organisation for Economic Co-operation and Development)

InternationalOrganisation grouping 30 industrialised countries:

Australia

Austria

Belgium

Canada

Czech Republic

Denmark

Finland

France

Germany

Greece

Hungary

Iceland

Ireland

Italy

Japan

Luxembourg

Mexico

The Netherlands

New Zealand

Norway

Poland

Portugal

Slovak Republic

South Korea

Spain

Sweden

Switzerland

Turkey

United Kingdom

United States

objectives
Objectives

Protect Man and Environment

Efficiency

High Quality Instruments

  • Share the Burden;
  • Avoid duplication;
  • Avoid non-tariff barriers to trade
estimated numbers of chemicals epa estimations 1995
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

3,300

(millions of products)

/year (1,000 in US)

(21,000 products)

(40,000 products)

data quality ensured by
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

slide10
“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.”

1981 OECD Council Decision on the Mutual Acceptance of Data For Assessment of Chemicals

mad and non member countries
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

publication of oecd test guidelines
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
slide13

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

Int’l Orgs.

Int’l Sci. Societies

Draft Proposal

for TG

WNT

Final TG

Proposal

Meetings

Commenting

Round(s)

Publication

JM

EPOC

Council

Final Test

Guideline

Implementation

OECD Test Guideline Development Process

procedure for the development of oecd test guidelines
Procedure for the Development of OECD Test Guidelines
  • 1. Submission of the proposal by:
  • Member country
  • BIAC
  • TUAC
  • International Scientific Society
  • Secretariat
procedure for the development of oecd test guidelines1
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
procedure for the development of oecd test guidelines2
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
procedure for the development of oecd test guidelines3
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
procedure for the development of oecd test guidelines 2
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 documents:essential or helpful
    • For guidance documents: linked to a specific TG or for general guidance
procedure for the development of oecd test guidelines4
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
oecd test guideline development process
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

Int’l Orgs.

Int’l Sci. Societies

Revised Draft TG Proposal

WNT

Final TG

Proposal

Meetings

Commenting

Round(s)

JM

EPOC

Council

Publication

Final Test

Guideline

Implementation

procedure for the development of oecd test guidelines5
Procedure for the Development of OECD Test Guidelines

4. Start of the Project

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

Subject Areas For Which Member Countries Have Nominated National Experts
  • Total number of Experts in the data base: 6,000
test guidelines programme

VMG - mammalian

VMG - eco

Test Guidelines Programme

WNT

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

EDTA

test guidelines programme expert review of draft documents
Test Guidelines ProgrammeExpert Review Of Draft Documents

OECD Secretariat’s 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)

Organisation’s

Position Paper

Industry’s

Position Paper

Secretariat

procedure for the development of oecd test guidelines6
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
procedure for the development of oecd test guidelines7
Procedure for the Development of OECD Test Guidelines
  • Secretariat Involvement
  • Workshop
  • ad hoc Expert Group Meeting
  • Nominated Expert Meeting

6. Arranging for Expert Meeting

procedure for the development of oecd test guidelines8
Procedure for the Development of OECD Test Guidelines
  • Reaching scientific consensus
  • Approval by National co-ordinators
  • Endorsement by Joint Meeting
  • EPOC Approval for Submission to Council
  • Council Endorsement

7. Adoption of new Guideline

slide28

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

Int’l Orgs.

Int’l Sci. Societies

Draft Proposal

for TG

WNT

Final TG

Proposal

Meetings

Commenting

Round(s)

Final Test

Guideline

Publication

JM

EPOC

Council

Implementation

chemicals programme and animal welfare
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;
slide30

Guidance Document on the Recognition, Assessment,

and Use of Clinical Signs as Humane Endpoints for

Experimental Animals Used in Safety Evaluation

ifcs ii february 1997 recommended that iomc should
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.

task force on endocrine disrupters testing and assessment edta
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
endocrine disrupters testing and assessment
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
endocrine disrupters testing and assessment1
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
validation work
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.
sharing the burden of testing and assessment
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.
sharing the burden of testing and assessment1
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.
sharing the burden of testing and assessment2
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 Children’s Health Programme (USA).
sharing the burden of testing and assessment3
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.
slide41

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).
for further information on oecd environment health and safety division
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