1 oecd what is it –forum for policy dialogue and development based on science and technology...

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OECD What is it

– Forum for policy dialogue and development based on science and technology

– Centre for policy research– Provider of instruments for

harmonisation, co-operation, cost sharing and outreach

– A “club” of 30 industrialised countries

What is it not– Provider of

technical assistance

– Supranational ruling body

– UN Organisation– European

Organisation– Bank

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OECD(Organisation for Economic Co-operation

and Development)

International Organisation grouping 30 industrialised countries:

AustraliaAustriaBelgiumCanadaCzech RepublicDenmarkFinlandFranceGermanyGreece

PolandPortugalSlovak RepublicSouth KoreaSpainSwedenSwitzerlandTurkeyUnited KingdomUnited States

HungaryIcelandIrelandItalyJapanLuxembourgMexico The NetherlandsNew ZealandNorway

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OECD Programmes of work

economic policy; education,

employment, labour and social affairs;

energy; environment; financial, fiscal and

enterprise affairs; food, agriculture and

fisheries;

international trade; public

management; science, technology

and industry; statistics; territorial

development; development

cooperation

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OECD: Structure of the Organisation (1)

Council of Ambassadors to OECD

Government Representatives to Chemicals Programme

Environmental Policy Committee (EPOC)

Joint Meeting

Member Countries’ Governments

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Working Party on Chemicals,Pesticides and Biotechnology

Chemicals Committee

Joint Meeting

OECD: Structure of the Organisation (2)

5 Working Groups:Test Guidelines Programme

Chemical Accidents

Pesticides

Biotechnology

GLP

5 Task Forces: HCL

Existing Chemicals

New Chemicals

PRTR

Novel Foods and Feeds Safety

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OECD: Structure of the Organisation

Numbers of OECD Secretariat staff: Total OECD: approx. 2000 Environment Directorate: approx. 100 EHS Division (9 Programmes): approx. 28 Test Guideline Programme: approx. 8

OECD offices: Paris (Headquarters) Bonn, Mexico City, Tokyo, Washington

(publication centers).

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Environment, Health and Safety Division Objectives and Activities

Protect Man and Environment

Efficiency

Share the Burden;

Co-ordination;

Avoid duplication;

Avoid non-tariff barriers to trade

High Quality Instruments;

Outreach;

Harmonisation

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Sharing the Burden

Investigating High Production Volume Chemicals

Hazard/Risk Assessment Methods

Pesticide (Re-) registration

Risk Reduction

Information Exchange

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Co-ordination

Risk Management

Capacity Building

Endocrine Disruptors

PRTR

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Outreach

Transfer of Expertise

Transfer of Policy Experience

Formal Co-operation - MAD

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Role of science in OECD policies

All OECD agreements, policies and other products are developed by consensus;

Scientific or technical agreement is the first step in the processes leading to OECD’s policy decisions:

“Science rules, policy rules” Some examples of the work in

practice…

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Role of science in OECD policies

“De-coupling environmental issues from economic growth”

(Environmental

strategy for the first decade of the 21st century, May 2001)

“Economic growth is key to environmental progress”

(President George W. Bush, 15 February 2002)

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GHS:Globally Harmonised

System for Classification and Labelling of

Chemicals and Chemical Mixtures

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What is the GHS?

A common and coherent approach to defining and classifying hazards, and communicating information on labels and safety data sheets;

Target audiences include workers, consumers, transport workers, and emergency responders;

Provides the underlying infrastructure for establishment of national, comprehensive chemical safety programs.

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GHS:Globally Harmonised System for Classification and Labelling of

Chemicals and Chemical Mixtures1. Hazard Classification of Substances Human Health Hazards (9 classes) Hazards to the Environment (1 class) Physical/Chemical Hazards (10 classes)

2. Hazard Classification of Mixtures Human Health Hazards (7 classes) Hazards to the Environment (1 class)

3. Hazard Communication Label elements Safety Data Sheets

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Step 1 Detailed Review Document (DRD)

a) Overview of available classification systems in a given area

b) Thorough analysis, including the scientific basis of each system

Step 2 Proposal for a harmonized classification system, leaving options for discussion; agreement of the Expert Group

Step 3 Discussion of the proposed harmonized classification system by the Task Force; reaching consensus and approval of the proposal

Sequential Approach - The Process of Harmonisation of Classification

Systems

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Policy and Expert Groups of the Harmonisation of Classification and

Labelling ProjectTask Force on Harmonisation of

Classification and Labelling (TF-HCL)

Expert Group on:Acute Toxicity

Expert Group on:Mutagenicity

Expert Group on:Reproductive Toxicity

Expert Group on:Specific Target Organ Systemic Toxicity

Expert Group on:Carcinogenicity

Expert Group on:Aquatic Environmental Hazards

Expert Group on:Classification Criteria for Mixtures

8 Drafting Groups

Expert Group on:Water Activated Toxicity

Expert Group on:Aspiration Hazards

Expert Group on:Respiratory Tract Irritation

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Sequential Approach - The Process of Harmonisation of

Classification Systems

Step 4 Endorsement of the proposed harmonized classification system by OECD Member countries at the Joint Meeting (Policy decision)

Step 5 Acceptance via IOMC by UN ECOSOC (Sub)Committee on GHS for inclusion in GHS

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The long and winding road to scientific consensus

Example: aquatic environmental hazards (1):

Two separate Expert Groups, later combined (total of approx. 60 experts);

Work started in February 1995 and finished in June 2001;

10 face-to-face meetings, 50-60 teleconferences;

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The long and winding road to scientific consensus

Example: aquatic environmental hazards (2): Achievements:

– Harmonised classification systems for chemical substances and mixtures;

– Comprehensive Guidance Document on the use of the classification system for aquatic environmental hazards;

– Guidance Document for the conduct of the Transformation/Dissolution protocol for metal compounds.

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The development of OECD Test Guidelines as standard reference tools for chemical

testing.

The story of MAD

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“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

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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) International standard open to all

interested WTO members

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Procedure for the development of an OECD Test Guideline (1):

Submission of the proposal to develop a Test Guideline;

Completion of the Standard Project Submission Form (SPSF);

Priority setting by National Co-ordinators;

Start of the project;

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Procedure for the development of an OECD Test Guideline (2)

Establishment of ad hoc Expert Group; Consider details of the method and

validation status; Review of the draft guideline proposal; Analysis of comments; Expert meeting(s);

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Total number of Experts in the data base: 6,000

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

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Test Guidelines ProgrammeExpert Review Of Draft

Documents

Partner Organisations:

• EC/ECB• ICH• IOMC• ISO• others

Industry Organisations:

• BIAC• ECETOC• GIFAP• CMA• COLIPA• others

National Position Paper(responsibility of the

National Co-ordinator)Organisation’sPosition Paper

Industry’sPosition Paper

Secretariat

OECD Secretariat’s Document

National Co-ordinators

Academia Government Industry

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Procedure for the development of an OECD Test Guideline (3):

Review of the revised guideline proposal;

Approval of the draft Test Guideline by WNT;

Endorsement at policy level; Adoption by Council; Publication as Addendum to Council

Decision C(81)30(Final).

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OECD Test Guideline Development Process

Member Countries

TUAC

BIAC

NGOs

Int’l Sci. Societies

Secretariat

Int’l Orgs.

Proposal for Test Guideline (TG)

Development

WNT

Draft Proposal for TG

Meetings

CommentingRound(s)

Revised DraftTG Proposal

Final TG ProposalWNT

JM EPOC CouncilFinal TestGuideline Implementation

Publication

Small ad hocExpert Group

SPSFEssential CriteriaDesirable Criteria

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Genetically Modified Foods and Feeds (GMFs) (or Products of Modern

Biotechnology) and the Precautionary Principle

Where science and policy are intertwined…

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GMF’s and Precaution

The safety of genetically modified foods/feeds:

“Precautionary Principle”: concept description appreciated by a number of countries as appropriate, by others as too strongly science-driven;

“Precautionary Approach”:concept description appreciated by all.

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Precautionary Approach interpreted as:

In case of lack of scientific certainty: use of the is not allowed; more data should be generated;

or:

In case of lack of scientific certainty:adjust (increase) the safety/uncertainty factor(s), allow use of the GMF and develop more data.

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Arguments heard: “Lack of scientific certainty” is not

defined; requiring more data could be used as a tool to control/avoid the import of GMF containing foods/feeds: non-tariff trade barrier.

Increasing the safety factor does not make up for insufficient data: there could be a long term major environmental/health effect.

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Member countries have not been able to reach consensus on data requirements for GMF’s;

Focus in OECD is on science-based “Consensus Documents” on specific novel foods/feeds that can be used for national regulatory assessments.

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