Writing Seveso II safety reports: new EU guidance reflecting 5 years' experience with the Directive

Since the coming into force of the Seveso II Directive, considerable experience has been acquired in regard to preparation of safety reports for establishments that fall under the requirements of this Directive. In light of this experience, the Amendment of the Seveso II Directive adopted by the European Parliament and the Council on 16 December 2003, gave the European Commission the mandate "to review by 31 December 2006 in close cooperation with the Member States, the existing Guidance on the Preparation of a safety report (EUR 17690)". As a result, a technical working group of Member States representing the Seveso competent authorities and the European Commission's Major Accident Hazards Bureau was established to review and re-examine the guidance. The new guidance maintains the high-level and overarching character of the older version, but improves the document through better definition of conceptual elements of the safety report and greater alignment with Annex II of the Directive, which describes the essential elements of the safety report. This paper describes the new guidance in terms of its contribution to developing a harmonized conceptual framework for preparing and reviewing safety reports within the context of Seveso II implementation. Overall, the aim of the guidance is to provide concrete advice to operators and competent authorities on the logic and expectations underlying the safety report, so as to make both preparation and review of the report a more efficient and useful exercise for all parties involved.     

The AETL methodology as a potential solution to current challenges associated with the development and use of acute exposure levels in Seveso II applications

This paper analyses current trends in the development and use of acute exposure levels in Europe for the implementation of the Seveso II Directive [Council Directive 96/82/EC of December 9, 1996 on the control of major-accident hazards involving dangerous substances. Official Journal of the European Communities, vol. L 10, January 14, 1997, Luxembourg, pp. 13-33]. It also describes a new initiative to develop a European methodology for deriving acute exposure threshold levels that responds to emerging needs in this area. The need for acute exposure values to predict human health effects of potential accidents on exposed populations has burgeoned in recent years. As the driving legislation for managing industrial hazards in Europe, the Seveso II Directive has particularly influenced this trend. Yet at this time it is questionable whether the availability and range of acute exposure values for toxic substances has kept apace with the growing need. Results of a survey of Seveso II competent authorities in the EU-15 revealed that a variety of different types of acute exposure values (AEGLs, EPRGs, etc.) are used for Seveso II applications. Moreover, a comparison of these values indicates gaps in coverage of substances as well as inconsistencies in terms of how health effects and exposure periods are defined for each type. These findings highlight an opportunity for greater collaboration on scientific inputs to application of the Directive in Europe. The ACUTEX project is an EU-funded research project aimed at furthering scientific exchange and collaboration in support of the development of acute exposure levels for toxic substances in Europe. Its goal is to develop a European methodology for deriving acute exposure threshold levels (AETLs). In particular, it provides the possibility for a common European platform for developing additional acute exposure values to meet emerging needs and cover more chemical substances. To maximise success, the work plan is designed to meet two very important challenges, the need to complement and add value to the existing array of acute exposure methodologies and the necessity of meeting requirements of a diverse range of European stakeholders. As such the project will draw on collaboration among European scientists and process of deliberation among stakeholders to deliver the following key results: (1) to facilitate wide acceptance of the methodology in Europe by both the scientific community and communities of different end-users; (2) to provide greater equivalence and transparency in implementation of the Seveso II Directive across the Member States, specifically through the development of common scientific bases for assessing risks and making risk management decisions related to toxic releases; (3) to produce a methodology that remains open to future collaboration on derivation of acute exposure levels on a European and a global basis.     

The use of geographic information systems in major accident risk assessment and management

The paper discusses the use of modern information technologies, and in particular geographic information systems (GIS), in the management and control of major accident risk. For this purpose, the regulatory framework of the recent "Seveso II" Directive is briefly described. This asks for more transparent procedures and decision-making, and requires consultation of the public in land-use and off-site emergency planning. Correspondingly, new demands are put to support tools being developed. The main features of tools dealing with hazard sources mapping, risk assessment, risk management, and emergency planning are discussed and examples are given. Moreover, it is argued that, if appropriately designed, their use can enhance the dialog between plant operators, authorities and the public to facilitate a consensus on risk issues. Finally, limitations in the use of these tools and prospects for future developments are discussed.     

Precautions against industrial accidents: experience in applying the Seveso II Directive in central and eastern European countries.

Adopted approaches to safety reports and internal emergency plans are described. Based on the provisions of the Seveso II Directive and on the achieved state of hazard prevention management of the respective enterprises in central and eastern European states, reports and plans were prepared. Although these states are no members of the European Union, the parties recognised the requirements of the Seveso II Directive as a working basis. In detail: Methodical experience in preparing safety reports and emergency plans include a methodology in the three main steps: Analysis of information on hazardous substances, hazard analysis including all plants, more specific hazard analysis for representative plants. Basic ways of forming scenarios are given. According to a procedure, various types of scenarios were usually taken into account. Based on the assessment of effects of a substance release, important conclusions can be drawn regarding the extent of danger prevention. In most cases, the structure of the described internal accident emergency plan turned out to be helpful. The programmed system DISMA (Disaster Management) which is widely used in Germany turned out to be a suitable tool for the internal as well as external emergency planning. An example of information to the population is described.     

A "worst case" methodology for obtaining a rough but rapid indication of the societal risk from a major accident hazard installation

This paper describes a methodology developed to provide a rough but rapid indication of the magnitude of the societal risks at and in the vicinity of a major accident hazard installation. It is intended to be used by the UK Health & Safety Executive (HSE) as a first screening tool when examining safety reports submitted under The Control of Major Accident Hazards (COMAH) Regulations 1999. These are the Regulations which implement in the UK the major aspects of Council Directive 96/82/EC, the "Seveso II" Directive. Within the methodology a new weighted risk integral parameter is defined, suitable for comparison with criteria, and its value calculated. The paper includes examples to illustrate the use of the methodology.     

Risk-maps informing land-use planning processes A survey on the Netherlands and the United Kingdom recent developments

The definition of safety distances as required by Art 12 of the Seveso II Directive on dangerous substances (96/82/EC) is necessary to minimize the consequences of potential major accidents. As they affect the land-use destinations of involved areas, safety distances can be considered as risk tolerability criteria with a territorial reflection. Recent studies explored the suitability of using Geographical Information System technologies to support their elaboration and visual rendering. In particular, the elaboration of GIS "risk-maps" has been recognized as functional to two objectives: connecting spatial planners and safety experts during decision making processes and communicating risk to non-experts audiences. In order to elaborate on these findings and to verify their reflection on European practices, the article presents the result of a comparative study between the United Kingdom and the Netherlands recent developments. Their land-use planning practices for areas falling under Seveso II requirements are explored. The role of GIS risk-maps within decisional processes is analyzed and the reflection on the transparency and accessibility of risk-information is commented. Recommendations for further developments are given.     

Emergency planning and the Control of Major Accident Hazards (COMAH/Seveso II) Directive: an approach to determine the public safety zone for toxic cloud releases

The EU Control of Major Accidents Hazards Directive (Seveso II) requires an external emergency plan for each top tier site. This paper sets out a method to build the protection of public health into emergency planning for Seveso sites in the EU. The method involves the review of Seveso site details prescribed under the directive. The site safety report sets out the potential accident scenarios. The safety report's worst-case scenario, and chemical involved, is used as the basis for the external emergency plan. A decision was needed on the appropriate threshold value to use as the level of concern to protect public health. The definitions of the regulatory standards (air quality standards and occupational standards) in use were studied, how they are derived and for what purpose. The 10 min acute exposure guideline level (AEGL) for a chemical is recommended as the threshold value to inform decisions taken to protect public health from toxic cloud releases. The area delimited by AEGL 1 defines the population who may be concerned about being exposed. They need information based on comprehensive risk assessment. The area delimited by AEGL 2 defines the population for long-term surveillance when indicated and may include first responders. The area delimited by AEGL 3 defines the population who may present acutely to the medical services. It ensures that the emergency responders site themselves safely. A standard methodology facilitates discussions with plant operators and concerned public. Examples show how the methodology can be adapted to suit explosive risk and response to fire.     

Effect of pre-treatments on hydrolysis and methane production potentials of by-products from meat-processing industry

Language issues are problems with communication via speech, signs, gestures or their written equivalents. They may result from poor reading and writing skills, a mix of foreign languages and other circumstances. Language issues are not picked up as a safety risk on the shop floor by current safety management systems. These safety risks need to be identified, acknowledged, quantified and prioritised in order to allow risk reducing measures to be taken. This study investigates the nature of language issues related danger in literature, by experiment and by a survey among the Seveso II companies in the Netherlands. Based on human error frequencies, and on the contents of accident investigation reports, the risks associated with language issues were ranked. Accident investigation method causal factor categories were found not to be sufficiently representative for the type and magnitude of these risks. Readability of safety related documents used by the companies was investigated and found to be poor in many cases. Interviews among regulators and a survey among Seveso II companies were used to identify the gap between the language issue related dangers found in literature and current best practices. This study demonstrates by means of triangulation with different investigative methods that language issue related risks are indeed underestimated. A recommended coarse of action in order to arrive at appropriate measures is presented.     

Safety issues in modern applications of robots

Since January 1995, machines not undergoing the appropriate European Community conformity assessment and not declared to comply with the essential health and safety requirements of the Machinery Directive may not be marketed in the European Community. The Machinery Directive fundamentally changes the way new machinery should be developed for safety. This paper outlines the requirements of the Machinery Directive and discusses potential difficulties in validating the safety of computer controlled machinery, particularly that used in robotics. The paper concludes that the way to address these problems practically is to use a thought through, risk based, quality approach that is used in the draft international standard IEC 1508.     

From LESSEPS to the workstation for reliability engineers

Three Mile Island and Chernobyl in the nuclear industry, Challenger, in the space industry, Seveso and Bhopal in the chemical industry—all these accidents show how difficult it is to forecast all likely accident scenarios that may occur in complex systems. This was, however, the objective of the probabilistic safety assessment (PSA) performed by EDF at the Paluel nuclear power plant. The full computerization of this study led to the LESSEPS project, aimed at automating three different steps: generation of reliability models—based on the use of expert systems, qualitative and quantitative processing of these models using computer codes, and overall management of PSA studies. This paper presents the results obtained and the gradual transformation of this first generation of tools into a workstation aimed at integrating reliability studies at all stages of an industrial process.     

Assessment of requirements on safety management systems in EU regulations for the control of major hazard pipelines

The European Commission has carried out a thorough review and assessment on whether pipelines conveying dangerous substances need a level of control similar to chemical installations, based on consideration of the hazards and risks and on accidents world-wide. The study examines whether sufficient controls already exist within the European Union (EU) Member States, considering the control philosophy of the 'Seveso II' Directive and the need to support development of pipeline networks across the EU taking into account the principles of sustainability. Community legislation would be supported by a set of criteria for the classification of Major-Accident Hazard Pipelines. Such criteria are examined for the onshore transmission pipelines in the EU. The Commission study has shown that there is a large variation in the degree to which Member States have comprehensive 'major-accident hazard' legislation on pipelines, and that existing legislation rarely addresses elements of the Safety Management System. The assessment, based on a proposed Pipeline Safety Instrument, indicates that there will be added value in a European Instrument drawing on the principles of Seveso II Directive concerning Safety Management System requirements.     

Application of land-use planning criteria for the control of major accident hazards: a case-study

Land-use planning (LUP) with respect to major accident hazards is one of the more important requirements of Directive 96/82/EC (the so-called Seveso II Directive). Different approaches were developed by the Member States of the European Union in order to implement this aspect of the Directive. This study focuses on the comparison of the specific approaches developed for LUP with respect to major accidents hazards. An Italian industrial area has been selected to perform a case study. The different LUP criteria have been used both to evaluate the present state of the area and the effect of several proposed hazard reduction actions. The results obtained have allowed a comparison of the different LUP methodologies. Critical steps in the application of the different LUP criteria have been identified, and the different priorities of hazard reduction actions resulting from risk-based and consequence-based approaches have been highlighted.     

The accidental risk assessment methodology for industries (ARAMIS)/layer of protection analysis (LOPA) methodology: A step forward towards convergent practices in risk assessment?

In the last ten years, layer of protection analysis (LOPA) emerged as a simplified form of quantitative risk assessment (QRA). The European Commission funded project Accidental Risk Assessment Methodology for Industries in the context of the Seveso 2 Directive (ARAMIS) has recently been completed. ARAMIS has several modules which give a consistent simplified approach to risk assessment which does not approach the complexity or expense of full QRA. LOPA is potentially a means of carrying out the assessment of barriers required in ARAMIS. This paper attempts to explain the principles of LOPA and the means by which it can be used within ARAMIS.     

Alerting the population in emergency plans: examples of local public policy in Provence

Article 8 of the European Seveso-1 Directive on 1982 imposed that the measures of self-protection to be adopted in the event of an industrial disaster were to be supplied to all persons who might have been concerned by a major accident. The second version of the Seveso Directive calling for a larger public participation has been applicable in France since February 3, 1999. At the dawn of this new text coming into effect, it is necessary to draw up the balance sheet of the actions undertaken in the field.In France, the public authorities and industrialists were actively engaged in this public policy of increasing public awareness of the industrial risks and safety measures to be applied in case of an accident. The first information campaign was launched in the spring of 1989. To evaluate the impact of this campaign, we will compare the results of three sociological surveys in the area: the first was carried out during the months of January and February 1988 before the public awareness campaign. The second survey was completed in December 1989 after the information campaign. The third and final survey was just after a major accident at the Total plant at La Mède.Insights from public reactions show needs for an appropriate sociological background so that information to the public might correspond to citizens' expectations.     

Introduction of threat analysis into the land-use planning process

The subject of this paper is a method for introducing risk assessment into the land-use planning (LUP) process. Due to adaptations of the results of risk assessment, which are needed to make the risk assessment usable by land-use planners, we term the overall process threat analysis. The key features of the threat analysis can be summarised as follows. (i) It consists of three main steps. The first is determination of the threat intensity level of an accident, the second is analysis of the environmental vulnerability of the surroundings of an accident, and the third, integrating the previous two, is determination of a threat index in the accident impact zone. All three are presented in GIS based maps, since this is a common expression in LUP. (ii) It can and should be applied in the early stages of the LUP process. The methodology is illustrated by an example in the context of renewal of a land-use plan for the Municipality of Koper in Slovenia. The approach of threat analysis follows directions of the Article 12 of the Directive 96/82/EC of the European Commission (the Seveso II Directive).     

Substance prioritisation for the development of EU Acute Exposure Toxicity Thresholds (AETLs)

The aim of the EU Acute Exposure project, ACUTEX, is to develop a methodology for establishing European Acute Exposure Threshold Levels, EU AETLs, for toxic substances in relation to harm to people by inhalation. The development of AETLs is initially in the context of the risks of major accidents from chemical sites and in particular their regulation through the EU 'Seveso II' Directive. It is intended that AETLs can be used within Member States, where appropriate, to inform decisions on land-use planning and emergency planning. AETLs will not have a regulatory status. This paper describes: the selection of 21 preliminary substances to use as case studies in the development and testing of the AETL's methodology; and the development of a prioritisation methodology to inform initial substance selection for a possible further AETLs program. The work was based on consultation with experts drawn from EU major stakeholder groups. It included a Validation Exercise working with three Member States, which account for between approximately 40% and 50% of all EU Seveso II sites. From this Validation Exercise we infer that, if these three Member States are representative in terms of numbers of priority substances, then the number of EU higher priority substances for further AETLs development is unlikely to be much in excess of 50.     

The management of mechanical integrity inspections at small-sized “Seveso” facilities

The mechanical integrity (MI) of equipment has been controlled at all industrial facilities for many decades. Control methods and intervals are regulated by laws or codes and best practices. In European countries, the legislations implementing the Seveso Directives on the control of major accident hazards require the owner of establishments where hazardous chemicals are handled, to implement a safety management system (SMS). MI controls should be an integral part of the SMS. At large establishments this goal is achieved by adopting the RBI method, but in small-sized establishments with a limited budget and scanty personnel, a heuristic approach is more suitable. This paper demonstrates the feasibility and advantages of integrating SMS and MI by means of a simple method that includes a few basic concepts of RBI without additional costs for operator. This method, supported by a software tool, is resilient as it functions effectively in spite of eventual budget reductions and personnel turnover. The results of MI controls can also be exploited to monitor equipment condition and demonstrate the adequacy of technical systems to the Competent Authorities (CA). Furthermore, the SMS can “capture” knowledge resulting from MI experience and exploit it for a better understanding of risk.     

2010版《食品安全管理体系认证实施规则》新要求解读及实施探讨

本文针对2010年3月1日实施的《食品安全管理体系认证实施规则》,就其与2007年3月1日实施的《食品安全管理体系认证实施规则》变化的条款进行解析,并结合新规则的要求,对认证机构应如何实施食品安全管理体系认证进行探讨。     

Object oriented programming in production management—two pilot systems

This paper discusses AI-oriented production management systems using object oriented programming. The two pilot systems described here are both implemented using the Smalltalk-80 programming environment. One of the systems concerns production planning in dairy industries, while the other is a simulation tool for production flow analysis. The merits of object oriented programming in the design of the user interfaces are emphasised. The flexibility of the object oriented approach for stepwise development has been observed. Simulation method as a communication tool is used in both systems and the applicability of Smalltalk in simulation is demonstrated. Design effectiveness and efficiency has proven surprisingly good. The experiences introduced in the paper are based on two geographically disjoint research groups, having thus impact on the generality of the observations made.