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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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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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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.
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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.
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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.