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

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The role of industry and regulators in promoting
process and product safety
SRA-E 15th Annual Conference 11-13 September
2006, Ljubljana, Slovenia  Innovation and
Technical Progress Benefit without risk ?

• Jürgen Wettig
• Representation of the European Commission
• in Slovenia

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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.

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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.

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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.

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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.

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Overview on
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WHO does WHAT in the
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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

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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.

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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.

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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

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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).

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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.

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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.

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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.

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• Lets take a look at

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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

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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

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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 likelihood
  and severity

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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.

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So, in the absence of a standard

• Whichmethodologydo we use ???

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EU Research Policy - Aims

• To develop the European Unions 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 Unions 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.

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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.

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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.

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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

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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
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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.

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

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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).

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Synthesis (3)

• Importance to use scholarship societies and
  professional associations to defragment
  scientific work and develop research-based
  solutions suitable for industry and
  authoritiesgt 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
  Competitivenessgt ETP Industrial Safety is
  useful to take care of safety issues in
  technological development

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Thank you for your attention !!

• Jürgen Wettig
• Head of Administration
• Representation of the European Commission
• in Slovenia
• Breg 14
• 1000 Ljubljana
• Tel. [phone]
• Fax [phone]
• e-mail Juergen.Wettig_at_ec.europa.eu
• www.europa.eu.int/slovenia/