OECD

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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
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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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)
Member Countries Governments
Council of Ambassadors to OECD
Government Representatives to Chemicals Programme
Environmental Policy Committee (EPOC)
Joint Meeting
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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

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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 OECDs 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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GHSGlobally 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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GHSGlobally 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

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Sequential Approach - The Process of
Harmonisation of Classification Systems
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Policy and Expert Groups of the Harmonisation of
Classification and Labelling Project
Task Force on Harmonisation of Classification
and Labelling (TF-HCL)
Expert Group onAcute Toxicity
Expert Group onSpecific Target Organ Systemic
Toxicity
Expert Group onWater Activated Toxicity
Expert Group onMutagenicity
Expert Group onCarcinogenicity
Expert Group onAspiration Hazards
Expert Group onReproductive Toxicity
Expert Group onAquatic Environmental Hazards
Expert Group onRespiratory Tract Irritation
Expert Group onClassification Criteria for
Mixtures
8 Drafting Groups
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Sequential Approach - The Process of
Harmonisation of Classification Systems
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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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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)
• 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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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 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 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
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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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GMFs 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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GMFs 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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GMFs 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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GMFs and Precaution

• Member countries have not been able to reach
  consensus on data requirements for GMFs
• 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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