The role of industry and The role of industry and regulators in promoting regulators in promoting

process and product process and product safetysafety

Jürgen WettigJürgen WettigRepresentation of the European Representation of the European

CommissionCommissionin Sloveniain Slovenia

SRA-E 15th Annual ConferenceSRA-E 15th Annual Conference11-13 September 2006, Ljubljana, Slovenia11-13 September 2006, Ljubljana, Slovenia

« Innovation and Technical Progress: « Innovation and Technical Progress: Benefit without risk ?»Benefit without risk ?»

ObjectivesObjectivesof the presentationof 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.

Some initial remarks …Some initial remarks …

Industrial and technological Industrial and technological development are key factors development are key factors to the benefit of our society.to the benefit of our society.

… … continued …continued …

Some products and processes (from Some products and processes (from which our society benefits) can which our society benefits) can cause cause accidentsaccidents and are therefore and are therefore potentially potentially dangerousdangerous for for manman and and the the environmentenvironment..

… … continued …continued …

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

… … continued …continued …

Regulatory intervention, i.e. safety Regulatory intervention, i.e. safety legislation, is often prompted by legislation, is often prompted by accidents/incidents and therefore accidents/incidents and therefore “re-active” rather than preventive.“re-active” rather than preventive.

It can be seen as a democratically It can be seen as a democratically legitimated reaction/answer to legitimated reaction/answer to industrial and technological industrial and technological development.development.

… … continued.continued.

The European Community (EC) started The European Community (EC) started with 6 members in 1952 and has grown with 6 members in 1952 and has grown to the European Union (EU) with 25 to the European Union (EU) with 25 Member States by now.Member States by now.

The legislative competence of the EC has The legislative competence of the EC has increased significantly over the years increased significantly over the years through many amendments of the through many amendments of the Treaties.Treaties.

Examples forExamples forcommon protection goalscommon protection goals

Protection of the health of our citizensProtection of the health of our citizens– diseases, epidemicsdiseases, epidemics– water supply, foodstuffswater supply, foodstuffs– pollution of the environmentpollution of the environment– major accidentsmajor accidents

Protection of the workers at the Protection of the workers at the workplaceworkplace– work-related illnesseswork-related illnesses– accidents at workaccidents at work– major accidentsmajor accidents

Protection of the environmentProtection of the environment– flora, fauna, air/ozone layer, rivers/lakes/oceans flora, fauna, air/ozone layer, rivers/lakes/oceans

etc.etc.

Overview on …Overview on …

Industrial Risk Management

Control of products Control of processes

Nuclear Safety Chemical Plant Safety

WHO does WHAT in the … WHO does WHAT in the …

"Implementation“ of European safety legislation ?

Transpositioninto national laws,

regulations andadministrative provisions

Government

Application in practiceof the laws, regulations and

administrative provisionsand control

Industrialoperators

Nationalauthorities

Tasks of the European Tasks of the European CommissionCommission

Exercise the (sole) Exercise the (sole) ”right of proposal””right of proposal”– consultation of interested (=concerned) partiesconsultation of interested (=concerned) parties– elaboration of proposals for legislation elaboration of proposals for legislation

Control of transposition of Community lawControl of transposition of Community law– pursuit of cases of non-communication/notification pursuit of cases of non-communication/notification

or incomplete communication/notificationor incomplete communication/notification– detailed control of the laws, regulations or detailed control of the laws, regulations or

administrative provisions notifiedadministrative provisions notified Control of application in practiceControl of application in practice

– pursuit of complaintspursuit of complaints Infringement proceduresInfringement procedures

– Letter of formal noticeLetter of formal notice– Reasoned opinionReasoned opinion– Appeal before the European Court of JusticeAppeal before the European Court of Justice

New approach to technical New approach to technical harmonisation and standards harmonisation and standards

(1)(1)

introduces a clear separation of introduces a clear separation of responsibilities between the EC responsibilities between the EC legislator and the European standards legislator and the European standards bodies (CEN, CENELEC and ETSI) in the bodies (CEN, CENELEC and ETSI) in the legal framework allowing for the free legal framework allowing for the free movement of goods .movement of goods .

EC technical harmonisation Directives EC technical harmonisation Directives only define the "essential only define the "essential requirements", e.g. protection of requirements", e.g. protection of health and safety, that goods must health and safety, that goods must meet when they are placed on the meet when they are placed on the market.market.

New approach to technical New approach to technical harmonisation and standards harmonisation and standards

(2)(2)

The European standards bodies draw The European standards bodies draw up "harmonized standards", following up "harmonized standards", following a mandate issued by the European a mandate issued by the European Commission after consultation of Commission after consultation of Member States.Member States.

Compliance with harmonized Compliance with harmonized standards, of which the references standards, of which the references have been published in the Official have been published in the Official Journal of the EC and which have been Journal of the EC and which have been transposed into national standards, transposed into national standards, provides provides presumption of conformitypresumption of conformity to to the essential requirements of the EC the essential requirements of the EC technical harmonisation Directives.technical harmonisation Directives.

What are standards?What are standards?

““documents containingdocuments containing– technical specificationstechnical specifications– or other precise criteriaor other precise criteria

to be used consistently as to be used consistently as – rules, rules, – guidelines, or guidelines, or – definitions of characteristics, definitions of characteristics,

to ensure that materials, products, processes to ensure that materials, products, processes and services are fit for their purpose”and services are fit for their purpose”

Who makes standards?Who makes standards?

Standards are the result of Standards are the result of voluntaryvoluntary agreements between all interested agreements between all interested parties.parties.

They are developed at They are developed at – national (e.g. AFNOR, ANSI, BSI, national (e.g. AFNOR, ANSI, BSI,

CSBTS, DIN or SIS etc.) CSBTS, DIN or SIS etc.) – European (CEN, CENELEC, ETSI) or European (CEN, CENELEC, ETSI) or – international level (IEC, ISO).”international level (IEC, ISO).”

Why are Why are international/European international/European

standards needed ?standards needed ?

The existence of non-harmonized The existence of non-harmonized standards for similar technologies in standards for similar technologies in different countries or regions can different countries or regions can contribute to so-called "contribute to so-called "technical technical barriers to tradebarriers to trade".".

Harmonization diminishes trade Harmonization diminishes trade barriers, promotes security and safety, barriers, promotes security and safety, allows interoperability of products, allows interoperability of products, systems and services, and promotes systems and services, and promotes common technical understanding.common technical understanding.

From standards for products to From standards for products to process-related standards …process-related standards …

before 1987: only standards for before 1987: only standards for products existedproducts existed

1987: ISO 9000 series of standards 1987: ISO 9000 series of standards (quality management)(quality management)

1996: ISO 14001 (environmental 1996: ISO 14001 (environmental management) management)

Both, the ISO 9000 and the ISO 14000 Both, the ISO 9000 and the ISO 14000 series of standards are known as series of standards are known as generic management system generic management system standardsstandards. They are. They are applicable to all applicable to all sectors and all sizes of business.sectors and all sizes of business.

… … continued.continued.

Process-related generic standards have Process-related generic standards have already been developed in the areas of already been developed in the areas of quality management and quality management and environmental management.environmental management.

The development of a generic standard The development of a generic standard for risk-based decision making would for risk-based decision making would certainly represent a major step certainly represent a major step forward in achieving a common forward in achieving a common language in risk assessment across language in risk assessment across different technical areas and sectors.different technical areas and sectors.

““Let’s take a look Let’s take a look at …at …

Classical steps of Risk AnalysisClassical steps of Risk Analysis1. Hazard Identification1. Hazard Identification

Example from the Seveso II Directive, Annex Example from the Seveso II Directive, Annex II - III. Description of the installationII - III. Description of the installation

A. description of the main activities and A. description of the main activities and products of the parts of the establishment products of the parts of the establishment which are important from the point of view of which are important from the point of view of safety, safety, sources of major-accident riskssources of major-accident risks and and conditions under which such a major conditions under which such a major accident could happen, … ;accident could happen, … ;

C. description of C. description of dangerous substancesdangerous substances: …: …

Classical steps of Risk AnalysisClassical steps of Risk Analysis2. Risk Assessment/Analysis2. Risk Assessment/Analysis

Example from the Seveso II DirectiveExample from the Seveso II Directive Annex II – point IV. Identification and Annex II – point IV. Identification and

accidental risks analysis and prevention accidental risks analysis and prevention methodsmethods– A. detailed description of the possible A. detailed description of the possible major-major-

accident scenariosaccident scenarios and their and their probabilityprobability …; …;

Annex III - (ii) identification and evaluation of Annex III - (ii) identification and evaluation of major hazards - adoption and implementation major hazards - adoption and implementation of procedures for of procedures for systematically identifying systematically identifying major hazardsmajor hazards arising from normal and arising from normal and abnormal operation and the abnormal operation and the assessment of assessment of their likelihood their likelihood and severity;and severity;

Classical steps of Risk AnalysisClassical steps of Risk Analysis3. Consequence Assessment3. Consequence Assessment

Example from the Seveso II DirectiveExample from the Seveso II Directive Annex II point Annex II point B. assessment of the B. assessment of the extent extent

and severity of the consequencesand severity of the consequences of of identified major accidents;identified major accidents;

Annex III - (ii) identification and evaluation of Annex III - (ii) identification and evaluation of major hazards - adoption and major hazards - adoption and implementation of procedures for implementation of procedures for systematically identifying major hazards systematically identifying major hazards arising from normal and abnormal operation arising from normal and abnormal operation and the and the assessment of their assessment of their likelihoodlikelihood and and severityseverity;;

However, …However, …

.. the Seveso II Directive contains no .. the Seveso II Directive contains no detailed procedures and guidelines for detailed procedures and guidelines for risk assessment and management.risk assessment and management.

A variety of such procedures is A variety of such procedures is currently in use, employing different currently in use, employing different terminologies and underlying terminologies and underlying philosophies, making cross-comparison philosophies, making cross-comparison of results difficult.of results difficult.

So, in the absence of a standard So, in the absence of a standard ……

WhichWhichmethodologymethodologydo we use ???do we use ???

EU Research Policy - AimsEU Research Policy - Aims

To develop the European Union’s policy in the field of To develop the European Union’s policy in the field of research and technological development and thereby research and technological development and thereby contribute to the international competitiveness of contribute to the international competitiveness of European industry;European industry;

To coordinate European research activities with those To coordinate European research activities with those carried out at the level of the Member States;carried out at the level of the Member States;

To support the Union’s policies in other fields such as To support the Union’s policies in other fields such as

environment, health, energy, regional development environment, health, energy, regional development etc; etc;

To promote a better understanding of the role of To promote a better understanding of the role of science in modern societies and stimulate a public science in modern societies and stimulate a public debate about research-related issues at European debate about research-related issues at European level.level.

EU Research Policy - EU Research Policy - InstrumentsInstruments

One of the instruments used for the One of the instruments used for the implementation of this policy are implementation of this policy are multi-multi-annual Framework Programmesannual Framework Programmes which which help to organise and financially support help to organise and financially support cooperation between universities, cooperation between universities, research centres and industries - research centres and industries - including small and medium sized including small and medium sized enterprises.enterprises.

The current The current Sixth Framework Sixth Framework ProgrammeProgramme covers the period 2002- covers the period 2002-2006 and has a total budget of  €17.5 2006 and has a total budget of  €17.5 billion. billion.

ARAMISARAMIS((AAccidental ccidental RRisk isk AAssessment ssessment MMethodology for Industrieethodology for IndustrieSS))

Co-funded under Framework Programme 5Co-funded under Framework Programme 5 3 years (2002-2004)3 years (2002-2004) 15 main partners15 main partners 10 EU countries10 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.

ARAMIS - ResultsARAMIS - Results

Safety barrier approach : Safety barrier approach : – User Guide (http://aramis.jrc.it)User Guide (http://aramis.jrc.it)– A probabilistic approach but an alternative solution A probabilistic approach but an alternative solution

to traditional QRA and consequence-based to traditional QRA and consequence-based approachesapproaches

– Compatible with LOPA and IEC 61508 standardCompatible with LOPA and IEC 61508 standard– A series of tools to ease risk assessmentA series of tools to ease risk assessment

Exchange of practice among countries (partners Exchange of practice among countries (partners and reviewers) and and reviewers) and convergence of risk convergence of risk assessment approaches in Europeassessment approaches in Europe

SHAPE-RISKSHAPE-RISKSHARING EXPERIENCE ON RISK MANAGEMENT (HEALTH, SHARING EXPERIENCE ON RISK MANAGEMENT (HEALTH,

SAFETY AND ENVIRONMENT) TO DESIGN FUTURE INDUSTRIAL SAFETY AND ENVIRONMENT) TO DESIGN FUTURE INDUSTRIAL SYSTEMSSYSTEMS

Co-funded under Framework Programme 6Co-funded under Framework Programme 6

Duration: 3 years (2004-2007)Duration: 3 years (2004-2007)

19 European partners19 European partners

Six work packagesSix 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

SHAPE-RISK - ObjectivesSHAPE-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.

Graphical wrap-up …Graphical wrap-up …

Monitoring/control by Public authorities

Ethics,

Societal pressure

Parliament,Laws

Constitution, Court of Justice

Government

Industry,Standards,Technology,Research

Public Financing

Synthesis (1)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.

Synthesis (2)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).

Synthesis (3)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

Thank you for your Thank you for your attention !!attention !!

Jürgen WettigJürgen WettigHead of AdministrationHead of Administration

Representation of the European CommissionRepresentation of the European Commissionin Sloveniain Slovenia

Breg 14Breg 141000 Ljubljana1000 Ljubljana

Tel.: +386-1-252.88.01Tel.: +386-1-252.88.01Fax: +386-1-425.20.85Fax: +386-1-425.20.85

e-mail: e-mail: Juergen.Wettig@ec.europa.euJuergen.Wettig@ec.europa.euwww.europa.eu.int/slovenia/www.europa.eu.int/slovenia/