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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

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Presentation Transcript
slide1
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

OECD
slide2

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

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

OECD Programmes of work
oecd structure of the organisation 1
OECD: Structure of the Organisation (1)

Member Countries’ Governments

Council of Ambassadors to OECD

Government Representatives to Chemicals Programme

Environmental Policy Committee (EPOC)

Joint Meeting

oecd structure of the organisation 2

Joint Meeting

Working Party on Chemicals,Pesticides and Biotechnology

Chemicals Committee

OECD: Structure of the Organisation (2)
  • 5 Task Forces:
  • HCL
  • Existing Chemicals
  • New Chemicals
  • PRTR
  • Novel Foods and Feeds Safety
  • 5 Working Groups:
  • Test Guidelines Programme
  • Chemical Accidents
  • Pesticides
  • Biotechnology
  • GLP
oecd structure of the organisation
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).
environment health and safety division objectives and activities
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
sharing the burden
Sharing the Burden
  • Investigating High Production Volume Chemicals
  • Hazard/Risk Assessment Methods
  • Pesticide (Re-) registration
  • Risk Reduction
  • Information Exchange
co ordination
Co-ordination
  • Risk Management
  • Capacity Building
  • Endocrine Disruptors
  • PRTR
outreach
Outreach
  • Transfer of Expertise
  • Transfer of Policy Experience
  • Formal Co-operation - MAD
role of science in oecd policies
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…
role of science in oecd policies1
“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)

Role of science in OECD policies
ghs globally harmonised system for classification and labelling of chemicals and chemical mixtures
GHS:Globally Harmonised System for Classification and Labelling of Chemicals and Chemical Mixtures
what is the ghs
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.
ghs globally harmonised system for classification and labelling of chemicals and chemical mixtures1
GHS:Globally Harmonised System for Classification and Labelling of Chemicals and Chemical Mixtures
  • 1. 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
sequential approach the process of harmonisation of classification systems

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
policy and expert groups of the harmonisation of classification and labelling project
Policy and Expert Groups of the Harmonisation of Classification and Labelling Project

Task Force on Harmonisation of Classification and Labelling (TF-HCL)

Expert Group on:Acute Toxicity

Expert Group on:Specific Target Organ Systemic Toxicity

Expert Group on:Water Activated Toxicity

Expert Group on:Mutagenicity

Expert Group on:Carcinogenicity

Expert Group on:Aspiration Hazards

Expert Group on:Reproductive Toxicity

Expert Group on:Aquatic Environmental Hazards

Expert Group on:Respiratory Tract Irritation

Expert Group on:Classification Criteria for Mixtures

8 Drafting Groups

sequential approach the process of harmonisation of classification systems1

Step 4

Step 5

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

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

Sequential Approach - The Process of Harmonisation of Classification Systems
the long and winding road to scientific consensus
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;
the long and winding road to scientific consensus1
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.
the development of oecd test guidelines as standard reference tools for chemical testing

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

The story ofMAD

slide22
“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)
  • International standard open to all interested WTO members
procedure for the development of an oecd test guideline 1
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;
procedure for the development of an oecd test guideline 2
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);
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 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 an oecd test guideline 3
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).
slide29

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

slide30

Genetically Modified Foods and Feeds (GMFs) (or Products of Modern Biotechnology) and the Precautionary Principle

Where science and policy are intertwined…

gmf s and precaution
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.

gmf s and precaution1
GMF’s and Precaution

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.

gmf s and precaution2
GMF’s and Precaution

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.
gmf s and precaution3
GMF’s and Precaution
  • 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.