The role of industry and regulators in promoting process and product safety

1. SRA-E 15th Annual Conference 11-13 September 2006, Ljubljana, Slovenia « Innovation and Technical Progress: Benefit without risk ?» The role of industry and regulators in promoting process and product safety Jürgen Wettig Representation of the European Commission in Slovenia

2. Objectivesof the presentation • To explore and promote the operator-regulator relationship in high risk industrial activities as a “democratic approach”. • To promote the role of standards and research in the implementation of safety for products and processes. • To stimulate discussion at the Conference.

3. Some initial remarks … • Industrial and technological development are key factors to the benefit of our society.

4. … continued … • Some products and processes (from which our society benefits) can cause accidents and are therefore potentially dangerous for man and the environment.

5. … continued … • While the risk arising from certain products and processes can be reduced, “zero risk” is not realistic.

6. … continued … • Regulatory intervention, i.e. safety legislation, is often prompted by accidents/incidents and therefore “re-active” rather than preventive. • It can be seen as a democratically legitimated reaction/answer to industrial and technological development.

7. … continued. • The European Community (EC) started with 6 members in 1952 and has grown to the European Union (EU) with 25 Member States by now. • The legislative competence of the EC has increased significantly over the years through many amendments of the Treaties.

8. Examples forcommon protection goals • Protection of the health of our citizens • diseases, epidemics • water supply, foodstuffs • pollution of the environment • major accidents • Protection of the workers at the workplace • work-related illnesses • accidents at work • major accidents • Protection of the environment • flora, fauna, air/ozone layer, rivers/lakes/oceans etc.

9. Overview on …

10. WHO does WHAT in the …

11. Tasks of the European Commission • Exercise the (sole) ”right of proposal” • consultation of interested (=concerned) parties • elaboration of proposals for legislation • Control of transposition of Community law • pursuit of cases of non-communication/notification or incomplete communication/notification • detailed control of the laws, regulations or administrative provisions notified • Control of application in practice • pursuit of complaints • Infringement procedures • Letter of formal notice • Reasoned opinion • Appeal before the European Court of Justice

12. New approach to technical harmonisation and standards (1) • introduces a clear separation of responsibilities between the EC legislator and the European standards bodies (CEN, CENELEC and ETSI) in the legal framework allowing for the free movement of goods . • EC technical harmonisation Directives only define the "essential requirements", e.g. protection of health and safety, that goods must meet when they are placed on the market.

13. New approach to technical harmonisation and standards (2) • The European standards bodies draw up "harmonized standards", following a mandate issued by the European Commission after consultation of Member States. • Compliance with harmonized standards, of which the references have been published in the Official Journal of the EC and which have been transposed into national standards, provides presumption of conformity to the essential requirements of the EC technical harmonisation Directives.

14. What are standards? “documents containing • technical specifications • or other precise criteria to be used consistently as • rules, • guidelines, or • definitions of characteristics, to ensure that materials, products, processes and services are fit for their purpose”

15. Who makes standards? Standards are the result of voluntary agreements between all interested parties. They are developed at • national (e.g. AFNOR, ANSI, BSI, CSBTS, DIN or SIS etc.) • European (CEN, CENELEC, ETSI) or • international level (IEC, ISO).”

16. Why are international/European standards needed ? • The existence of non-harmonized standards for similar technologies in different countries or regions can contribute to so-called "technical barriers to trade". • Harmonization diminishes trade barriers, promotes security and safety, allows interoperability of products, systems and services, and promotes common technical understanding.

17. From standards for products to process-related standards … • before 1987: only standards for products existed • 1987: ISO 9000 series of standards (quality management) • 1996: ISO 14001 (environmental management) • Both, the ISO 9000 and the ISO 14000 series of standards are known as generic management system standards. They are applicable to all sectors and all sizes of business.

18. … continued. • Process-related generic standards have already been developed in the areas of quality management and environmental management. • The development of a generic standard for risk-based decision making would certainly represent a major step forward in achieving a common language in risk assessment across different technical areas and sectors.

19. “Let’s take a look at …

20. Classical steps of Risk Analysis1. Hazard Identification Example from the Seveso II Directive, Annex II - III. Description of the installation • A. description of the main activities and products of the parts of the establishment which are important from the point of view of safety, sources of major-accident risks and conditions under which such a major accident could happen, … ; • C. description of dangerous substances: …

21. Classical steps of Risk Analysis2. Risk Assessment/Analysis Example from the Seveso II Directive • Annex II – point IV. Identification and accidental risks analysis and prevention methods • A. detailed description of the possible major-accident scenarios and their probability …; • Annex III - (ii) identification and evaluation of major hazards - adoption and implementation of procedures for systematically identifying major hazards arising from normal and abnormal operation and the assessment of their likelihood and severity;

22. Classical steps of Risk Analysis3. Consequence Assessment Example from the Seveso II Directive • Annex II point B. assessment of the extent and severity of the consequences of identified major accidents; • Annex III - (ii) identification and evaluation of major hazards - adoption and implementation of procedures for systematically identifying major hazards arising from normal and abnormal operation and the assessment of their likelihoodand severity;

23. However, … • .. the Seveso II Directive contains no detailed procedures and guidelines for risk assessment and management. • A variety of such procedures is currently in use, employing different terminologies and underlying philosophies, making cross-comparison of results difficult.

24. So, in the absence of a standard … Whichmethodologydo we use ???

25. EU Research Policy - Aims • To develop the European Union’s policy in the field of research and technological development and thereby contribute to the international competitiveness of European industry; • To coordinate European research activities with those carried out at the level of the Member States; • To support the Union’s policies in other fields such as environment, health, energy, regional development etc; • To promote a better understanding of the role of science in modern societies and stimulate a public debate about research-related issues at European level.

26. EU Research Policy - Instruments • One of the instruments used for the implementation of this policy are multi-annual Framework Programmes which help to organise and financially support cooperation between universities, research centres and industries - including small and medium sized enterprises. • The current Sixth Framework Programme covers the period 2002-2006 and has a total budget of  €17.5 billion.

27. ARAMIS(Accidental Risk Assessment Methodology for IndustrieS) • Co-funded under Framework Programme 5 • 3 years (2002-2004) • 15 main partners • 10 EU countries • Objectives :To support a consistent implementation of the Seveso II Directive within the EU by creating a new integrated risk assessment methodology, combining the strong points from different methods currently used in the EU.

28. ARAMIS - Results • Safety barrier approach : • User Guide (http://aramis.jrc.it) • A probabilistic approach but an alternative solution to traditional QRA and consequence-based approaches • Compatible with LOPA and IEC 61508 standard • A series of tools to ease risk assessment • Exchange of practice among countries (partners and reviewers) and convergence of risk assessment approaches in Europe

29. SHAPE-RISKSHARING EXPERIENCE ON RISK MANAGEMENT (HEALTH, SAFETY AND ENVIRONMENT) TO DESIGN FUTURE INDUSTRIAL SYSTEMS • Co-funded under Framework Programme 6 • Duration: 3 years (2004-2007) • 19 European partners • Six work packages WP1 Integration of IPPC and SEVESO directives WP2 Continuity of risk management from work place accident to major accident WP3 Survey and comparison of common tools and service platform WP4 Improving the efficiency of the organisational management WP5 Policies for the management of environmental risks WP6 Public perception and communication on risk

30. SHAPE-RISK - Objectives • Risk management is related to : • Environment (IPPC Directive), • Major accident hazards (SEVESO II Directive) • Occupational Health and Safety (ATEX Directive) • To optimise the efficiency of integrated risk management in the context of the sustainable development of the European process industry.

31. Graphical wrap-up … Constitution, Court of Justice Monitoring/control by Public authorities Ethics, Societal pressure Industry, Standards, Technology, Research Parliament, Laws Public Financing Government

32. Synthesis (1) • Industrial operators bear the main responsibility for the safety of their products and processes. They are a driving force in research and technological development. • For certain potentially dangerous products or processes, society (through regulators) establishes safety regulations in a democratic decision-making process. Controls by public authorities represent an additional monitoring and QA layer.

33. Synthesis (2) • Goal-oriented legislation avoids burdensome and repeated adaptation to technical process. • International and European standards for the safety of products and processes promote common technical understanding and a coherent application of underlying safety requirements/legislation. • Research can and should be used to provide methodologies/guidance for the practical application of safety requirements/legislation and of principles such as ALARP or ALARA (= As Low As Reasonably Possible/Achievable).

34. Synthesis (3) • Importance to use scholarship societies and professional associations to defragment scientific work and develop research-based solutions suitable for industry and authorities=> SRA Europe is a good example for Risk Analysis ! • Promote initiatives like European Technology Platforms to develop long term vision and define research priorities (Strategic Research Agenda)that will develop European Industry Competitiveness=> ETP Industrial Safety is useful to take care of safety issues in technological development

35. Thank you for your attention !! Jürgen Wettig Head of Administration Representation of the European Commission in Slovenia Breg 14 1000 Ljubljana Tel.: +386-1-252.88.01 Fax: +386-1-425.20.85 e-mail: Juergen.Wettig@ec.europa.eu www.europa.eu.int/slovenia/