LIMITS? BEYOND LIMITS? DEALING WITH CHEMICAL RISKS AT WORK IN EUROPE
Related books AHMED, LIM & LO
Learning through Knowledge Management
FRICK
Systematic Occupational Health and Safety Management
HALE, HOPKINS & KIRWAN (eds.)
Changing Regulation: Controlling Risks in Society
HALE & BARAM
Safety Management and the Challenge of Organisational Change
HALE, WILPERT & FREITAG
After the Event: From Accident to Organisational Learning
PRUSAK
Knowledge in Organisations
VINCENT & DE MOL
Safety in Medicine
WILPERT & FAHLBRUCH
System Safety: Challenges and Pitfalls of Intervention www.elsevier.com
Related Journals Accident Analysis and Prevention Editors: R. Elvik and Karl Kim
Journalof Processing O p e r a t i o and ns Management Information Editor: R. T. Saracevic Hanfield Journal of Operations Management Editors:R.R.Hanfield Hanfield Editor: Journal of Safety Research Editors: T.W. Planek and M.-L. Lin Safety Science Editor: A.R. Hale
SCIENCE
R Dl R ECT®
LIMITS? BEYOND LIMITS? DEALING WITH CHEMICAL RISKS EUROPE AT WORK IN EUROPE
By DAVID WALTERS KAROLA GRODZKI
ELSEVIER Amsterdam -– Boston -– Heidelberg -– London -– New York -– Oxford Paris -– San Diego -– San Francisco -– Singapore -– Sydney -– Tokyo
ELSEVIERB.V. ELSEVIER B.V. Radarweg29 29 211,1000 P.O. Box 211, 1000 AE Amsterdam, The Netherlands
ELSEVIER Inc. 525 B Street Suite 1900, San Diego CA 92101-4495, USA
ELSEVIER Ltd. The Boulevard Langford Lane, Kidlington, Oxford OX5 1GB, UK
ELSEVIER Ltd. 84 Theobalds Road WC1X8RR London WC1X 8RR UK
© 2006 Elsevier Ltd. All rights reserved. copyiight by Elsevier Ltd., and the following This work is protected under copyright following terms and conditions apply to its use:
Photocopying copyiight laws. Permission Single photocopies of single chapters may be made for personal use as allowed by national copyright of the Publisher and payment of aa fee is required for all other photocopying, including multiple or systematic copying, adveitising or promotional puiposes, copying for advertising purposes, resale, and all forms of document delivery. Special rates are available non-profit educational classroom use. for educational institutions that wish to make photocopies for non-profit Permissions may be sought directly from Elsevier’s Elsevier's Rights Department in in Oxford, UK: phone (+44) 1865 843830, 1865 853333, e-mail:
[email protected]. permissions @elsevier.com. Requests may also be completed on-line via the Elsevier fax (+44) 1865 (http://www.elsevier.com/locate/permissions). homepage (http://www.elsevier.com/locate/permissions). Copyiight Clearance Center, Inc., 222 In the USA, users may clear permissions and make payments through the Copyright Rosewood Drive, Danvers, MA 01923, USA; phone: (+1) (978) 7508400, fax: (+1) (978) 7504744, and in the UK Copyiight Licensing Agency Rapid Clearance Service (CLARCS), 90 Tottenham Court Road, London through the Copyright W1P 0LP, UK; phone: (+44) 20 20 7631 5555; fax: 20 7631 5500. Other countries may have aa local fax: (+44) 20 reprographic rights agency for payments.
Derivative Works of contents may be be reproduced for of the Publisher is is required for Tables of for internal circulation, but permission of for or distribution of of such material. Permission of of the Publisher is is required for all other derivative external resale or for all works, including compilations and translations. orUsage Electronic Storage or of the Publisher is is required to store or or use electronically any material contained in in this work, including Permission of of aa chapter. any chapter or part of of this work may be reproduced, stored in in aa retrieval system or or transmitted in Except as outlined above, no part of in or by by any means, electronic, mechanical, photocopying, recording or or otherwise, without prior written any form or permission of the Publisher. Elsevier's Rights Department, at at the fax and e-mail addresses noted above. Address permissions requests to: Elsevier’s
Notice is assumed by the Publisher for any injury and/or damage to persons or property as as aa matter of No responsibility is orotherwise, or from oroperation of of any methods, products, instructions or products liability, negligence or from any use or or in the of rapid advances in in the in particular, ideas contained in the material herein. Because of the medical sciences, in independent verification verification of of diagnoses and drug dosages should be made. First edition 2006 of Congress Cataloging in in Publication Data Library of A catalog record is is available from from the Library of of Congress. British Library Cataloguing in in Publication Data is available from the British Library. A catalogue record is
ISBN-13: 978-0-08-044858-9 978-0-08-044858-9 ISBN-10: 0-08-044858-5 @ The paper used in this publication meets the requirements of ANSI/NISO Z39.48-1992 (Permanence of Paper). Printed in The United Kingdom.
Working together to grow libraries in developing countries www.elsevier.com | www.bookaid.org | www.sabre.org
ELSEVIER
BOOK AID International
Sabre Foundation
v
Acknowledgements The research that went into writing this book was made possible by funding from two separate sources. First, the UK Health and Safety Executive supported a study into systems and practices for setting and using occupational exposure limits in selected EU countries. Second, the Long-range Research Initiative (LRI) of the European Chemical Industry Council (CEFIC) funded an on-going study focused on the management of chemical risks in smaller enterprises in several EU countries. Material from both these studies has been used in the completion of the present volume. The authors are grateful for the assistance of numerous individuals, from both organisations that have been helpful throughout the research and writing of the book. We would especially like to thank members of the HSC Advisory Committee on Toxic Substances, Judy Caute, Carole Sullivan and Michael Topping of the HSE and Chris Money of CEFIC and the LRI. In preparing this book we have also been reliant on the aid of a substantial number of persons in each country in which our investigations have been undertaken. Representatives of trade unions, labour inspectorates, health and safety policy makers, employers' organisations, researchers and observers were not only willing subjects for interview but often played a key role establishing further contacts with important informants in each country. Although these people are too numerous to mention by name, the authors would like to acknowledge their debt to their active co-operation and help. Without it, this book would not have been possible. In addition, we would like especially to thank Ann-Beth Antonsson, Kaj Flick, Mat Jongen, Alex Karageorgiou, Gtinther Kittel, Jan Popma, Andrea Tozzi, Remco Visser, Janneke Waage, Kerstin Wahlberg and Henning Wriedt for facilitating contacts in the countries of the study and for helping with the content of the country chapters, Martin Axon and Ian Bartlett both formerly of South Bank University for assisting with organising the early part of the work and for stimulating discussion on the scientific/technical aspects of the subject. Hazel Slavirt and Nick Bailey provided additional editorial support and last but by no means least we are especially grateful to Sandra Bonney for her help in preparing the final version of the book and for working on the Index, While acknowledging the help of all these sources, the responsibility for the content and views expressed in the following pages and any inaccuracies or misrepresentations therein remains that of the authors.
This Page is Intentionally Left Blank
vii
TABLE OF CONTENTS INTRODUCTION: HAZARDS, RISKS AND LIMITS
1
2
1
Hazardous Substances - A Defining Concern of Occupational Health and Safety Why Focus on OELs? The Countries The Structure of the Book
2 5 9 11
THE PROBLEM OF CHEMICAL RISKS
13
Introduction Chemicals at Work in the EU Mortality, Morbidity and Occupational Exposure to Hazardous Substances in Europe Issues for the Role of OELs in Managing Work With Chemical Risks What are Occupational Exposure Limits and How Have They Developed? The Meaning and Use of Exposure limits New Directions in Regulating Risk Management of Hazardous Substances and the Role of OELs Conclusions: But What About Using OELs?
13 13
EXPOSURE LIMITS AND INSTITUTIONAL STRUCTURES FOR HAZARDOUS SUBSTANCE REGULATION IN THE EUROPEAN UNION , Introduction EU Legislative Frameworks for Minimising Health and Safety Risks of Dangerous Substances Requirements Regulating Chemical Risks Generally in the EU European Legislation With A Special Focus On Protecting Workers from the Risks Arising from Hazardous Chemicals OEL Setting at the European Level Effectiveness of the Existing Legislation and the Future Approach at Community Level
15 19 21 25 30 35
37 37 38 40 47 53 56
viii Beyond Limits
REACH and Worker Protection Conclusion
60 62
SYSTEMS FOR SETTING AND USING OCCUPATIONAL EXPOSURE LIMITS IN EU 15 COUNTRIES
65
Introduction Regulatory Systems and Responsible Bodies Implementing EU Requirements in EU 15 Member States Occupational Exposure Limit Values in the EU 15 Countries Procedures for Setting OELs Enforcement and Surveillance of Compliance with OELs in EU 15 Countries Austria Belgium Denmark Finland France Germany Greece Ireland , Italy Luxembourg Portugal Spain Sweden The Netherlands United Kingdom Conclusions
94 94 95 96 97 99 102 103 104 105 106 107 108 109 110 Ill 112
THE UNITED KINGDOM
119
,
,
Introduction Background: Legislative Reforms from the 1970s Regulating Risk Management of Hazardous Chemicals Using OELs at the Workplace New Approaches to Chemical Controls: A New Role for OELs? OELs and COSHH Essentials in Practice
65 67 72 73 84
119 120 123 135 147 152
Table of Contents ix
Summary of WEL Setting Procedures (After HSC 2003)
159
Conclusions: Applying the New Framework in Practice
161
GERMANY
171
,
Introduction The Background The Extent of the Problem of Chemical Exposure in Germany Regulating Chemical Risks - The Germany Health and Safety System in Outline The Legislative Framework for OELs Wood Dust Toluene Discussion: The role of OELs in Monitoring Compliance with Requirements to Manage the Use of Chemicals Safely GREECE Introduction The Regulatory Infrastructure Setting Exposure Limits The Role of OELs in Achieving Compliance - in Theory The Role of OELs in Regulating the Management of Risk in Practice Challenges for Regulating the Management of Chemical Risks in Greece Enhancing Competence in Relation to Hazardous Substances Qualifications of Safety Engineer Sector Specific Experience of Wood Dust and Toluene Conclusions: The Limited Role of OELs in Controlling Risks of Hazardous Chemicals in the Workplace
171 173 173 175 182 193 205 217 227 227 229 233 235 237 240 241 244 245 254
ITALY
261
Introduction , The Italian Model for Regulating Health and Safety at Work Legislative Background , Measures Regulating Chemical Risks Application in Practice
261 264 265 268 276
x Beyond Limits
8
9
10
Conclusions
286
THE NETHERLANDS
289
Introduction
289
The Infrastructure and Processes Involved in Setting OELs Political and Legislative Contexts Operating the Dutch Approach to OELs , Conclusions
291 296 303 315
SWEDEN
319
Introduction The Use of Chemical Substances at Work in Sweden Economic and Legislative Background The Swedish Approach to Regulating the Work Environment Setting OELs Achieving Compliance with OELs Conclusions
319 320 321 322 324 327 335
BEYOND LIMITS?-THE PLACE OF OELs IN THE NEW REGULATION OF CHEMICAL RISKS IN EUROPE
341
Introduction What are OELs for? The Changing Role of OELs in Regulatory Approaches to Achieving Chemical Risk Management The Way Forward?
341 343 .347 357
REFERENCES
367
INDEX
407
xi LIST OF FIGURES Figure 4.1 Figure 4.2 Figure 4.3 Figure 4.4 Figure 5.1 Figure 5.2 Figure 5.3 Figure 6.1
HSE'sTolerabilityofRisk Framework and OELs Setting OELs in the UK (after Topping 2001) Mechanism of actions involving OELs Summary ofWEL setting procedures (after HSC 2003) The German OHS system Aggregated data for Toluene Exposure measurements of Toluene Number of inspection visits and sanctions distributed by economic activity
131 133 144 159 179 210 211 239
xii
LIST OF TABLES Table 3.1 National institutions with responsibilities for developing occupational exposure limits and with their surveillance. 68 Table 3.2 Some common features of OEL terminology in EU 15 country lists 76 Table 3,3 Summary of procedures for setting OELs in EU 15 countries 84 Table 5.1 Number of businesses in woodworking and furniture 196 Table 5.2 Number of employees in woodworking and furniture 196 Table 6.1 Number of inspection visits 238 Table 6.2 Number of sanctions 238 Table 6.3 Qualification Requirements for Safety Engineers According to the Risk Classification of Enterprises 244
xiii LIST OF ANNEXES
Annex 1 Websites of Ministries and other bodies involved in Health and Safety
379
Annex 2 Transposition of Main European Chemical Legislation (workers protection against hazardous chemicals)
386
Annex 3 Source of legislative provisions and occupational exposure level lists
388
Annex 4 National Institutions responsible for setting OELs.
398
This Page is Intentionally Left Blank
1
INTRODUCTION: HAZARDS, RISKS AND LIMITS This book is a study of strategic approaches to managing the risks of working with hazardous substances in the European Union. Its central theme addresses developments at national and international levels concerning safety in the use of chemical substances at work. Its primary focus is the role of occupational exposure limits (OELs) in these developments and their translation - again with particular reference to OELs - into practices within workplaces and especially within the small and medium sized workplaces that constitute the vast majority of establishments in which people work in Europe. It sets out to answer two linked questions -
What drives informed and competent risk management in chemical health and safety? What is the role (if any) of OELs in this process?
In seeking the answers to these questions and contextualising them within wider approaches to occupational health and safety (OHS) management in Europe, the book explores the challenges hazardous substances pose for effective OHS management. It grew out of a research project commissioned by the Health and Safety Commission (HSC) Advisory Committee on Toxic Substances (ACTS) in the UK in 2002.1 The aim of that project was to inform discussion of reform of the UK system for setting occupational exposure limits (OELs) by providing information on systems adopted for this purpose in other EU countries and on how such OELs are used in practice at workplaces in these countries. The contents of the present volume represent a considerable development of these aims. They encompass an overview of the legislative frameworks and responsible bodies involved in setting OELs at EU level and in all EU 15 countries and a detailed study of policy and practice in the use of OELs in risk management of hazardous substances at national, sectoral and workplace levels in six of these countries. Based on this material, they further include the identification and analysis of the issues confronting strategic approaches to regulating risk management of
The full report of this research project is available from HSE Books. See Walters et al (2003).
2 Beyond Limits
hazardous substances, ways in which they are addressed at EU level and in the countries that are the focus of the study. Nevertheless the research that was undertaken for the ACTS study remains the basis for much of the empirical material included here. It has been updated and further developed since it was originally collected in 2002/3 and also includes additional material derived from a current study funded by the European Chemical Industry Council (CEFIC)2 concerned with approaches to risk management of hazardous substances in small enterprises across most of the same range of European countries covered by the original project. As we explore in Chapter 2, the subject is particularly topical in the light of current strategies on chemical risks at EU level. Although the focus of the book is on the EU 15 countries,3 the recent expansion of the Community to include a range of new member states with reconstituted health and safety systems that are considerably younger and less sophisticated than those presently found in northern European member states, makes its findings especially timely in relation to these countries too.
HAZARDOUS SUBSTANCES—A DEFINING CONCERN OF OCCUPATIONAL HEALTH AND SAFETY. For most people, the effects of exposure to hazardous substances are prominent amongst risks that they commonly associate with the work environment. From earliest times, ill effects of work on health have been linked with exposure to chemical substances in their various physical forms and especially to airborne chemicals in the form of dusts, fumes and gases. These associations, the need to find out more about them, and to avoid or control their effects, have been fundamental to the growth of the subject of occupational health and safety as a research and professional concern, to the role of regulation in the work environment and to both the development of organised labour and its health and safety strategies. There are historical inter-relationships between these various elements that have helped to define the way in which professional, regulatory and interest group approaches to the broad subject of health and safety has developed over the last two
This research project titled, 'A Review of Workplace Management Strategies for Chemicals in Small Enterprises" is funded by the CEFIC Long Range Research Initiative (LRI). It will be completed by mid-2006 and will be the subject of further publications. That is, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden and the United Kingdom.
Introduction 3 centuries in market economies. Central to them has been concern about hazardous substances. A further dimension of the role of hazardous substances in health and safety is the part they have played in the development of attitudes and awareness of risk and risk regulation in wider society. Interlinked with occupational concerns but encompassing both consumer and environmental interests, public concern about hazardous substances in the economy is now deeply engrained in civil society and has wide-reaching political, economic and regulatory dimensions embracing for example, the governance of risk from hazardous installations, consumer safety, and environmental contamination as well as healih and safety at work. The unchecked activity of chemical polluters and the effects of their pollution were amongst the formative concerns of environmental movements internationally from the late 1960s. They remain central to the concerns of both these social interest groups and the wider public. Parenthetically, the development of much of the ideas behind modern radical support for the reform of health and safety regulation has its roots in the same formative issues. Linked to them are also the changes that have taken place in public awareness of the role of government, industry and the scientific establishment in addressing the regulation of the risks of hazardous substances. Perceived failures in exercising such control effectively account to no small extent for the current low levels of public trust in these actors and their policies. At the same time, policy makers and regulators at sectoral, national and international levels, as well as interest groups that are engaged with policy and regulation at these levels, have all struggled to effect strategies for safe use of hazardous substances at work that are both rigorous and transparent. The current frameworks for setting OELs and the thinking behind them in different EU countries and at EU level are themselves products of such efforts. This is in part because although there is substantial concern about the hazardous nature of many substances that are used at work, it is equally self-evident that the economic worth of producing and using such substances and their value to society dictates their continuing and even increasing presence in the workplace. As a consequence, the risks of working with them, as well as the need to better understand and control their use, have been a primary focus for the scientific and engineering basis of monitoring and controlling the working environment that has guided the emergence of professional disciplines such as those of occupational hygiene, elements of safety engineering and occupational medicine, toxicology and related fields during their development over the past century and a half. In post-industrialised market economies organised labour has evolved strategic positions on achieving the regulation and control of the risks of
4 Beyond Limits hazardous substances that are themselves deeply rooted in the experiences of labour including the suffering of victims and their families - and which are not so much aimed at contributing to the science, engineering and technology of safe chemical usage as they are at ensuring the representation of the views and experiences of those affected by chemical hazards. At the same time, in most social democracies the structures and processes for regulating occupational risks share some common ground in as much as there is a place within them for social dialogue. Since the 1970s tripartitism in decision making on regulating health and safety has been increasingly the pattern in most EU member states and at European level reflecting, amongst other things, the orientation of regulatory provisions towards the processes of managing health and safety in which the participation of workers is seen as central to successful health and safety management. Representatives of industry and labour and their advisers therefore meet together with those of the state to decide on ways in which improvements are to be achieved in regulating occupational risks. The structures and procedures for setting OELs and deciding their regulatory status are constituted along these lines in most EU countries. In such forums issues of cost and practicability are central to decisions about control and this is as true for the regulation of the risks of hazardous substances as it is for health and safety matters generally. In these forums therefore, as well as organised labour the role of capital is a significant presence and both the chemical industry itself and representatives of employers that use chemicals provide a powerful lobby advocating the benefits of chemical substances they produce and use. In all of this an approach to safeguarding workers' health and safety has emerged where the moral high ground has been dominated by precautionary principles of control in which essentially ethical considerations demand a preferred sequence for the selection of appropriate controls to ensure maximum safety in the use of hazardous substances and where safety should not be assumed in the absence of proven risk. Within the hierarchy of control thus envisaged, for example removal of the risk of harm through substitution of unsafe substances with a safe one, is preferable to controlling the use of the substance though physical containment to prevent human contact. This in turn is preferred to minimising the risk of human contact with airborne contamination through provision of exhaust ventilation at source, itself a strategy that is seen as preferable to minimising human contact by behavioural controls for workers and the provision of protective equipment. Juxtaposed with such ethics are the essentially economic considerations behind the use to which the hazardous substance is being put and their value to wider society, as well as the economic and technical feasibility of the
Introduction 5
introduction of suitable health and safety control. Thus compromise situations result in which notions of managing risk to acceptable or tolerable levels are pursued within whichever value system is operational in the social, legal, political and economic context of the society and time in question.
WHY FOCUS ON OELS? Achieving such controls requires good quality information concerning the properties and known health effects of exposure to substances, as well as on the technical issues of achieving appropriate environmental control, in order that the feasibility of introducing particular control measures can be weighed against the consequences of exposure. Ideally, since the toxicity of a particular substance is usually dependent on a combination of its (toxic) properties and the quantity (dose) to which the subject is exposed, it should be possible to protect the health of workers by determining levels of exposure below which the risks to health are reduced to negligible levels. The idea of exposure limits for hazardous substances in workplace health and safety developed from this. First proposed by individuals in the late 19th century, subsequently developed into nationally applicable lists in the first half of the 20th century and most conspicuously represented by the American Conference of Governmental Industrial Hygienists' (ACGIH) list of Threshold Limit Values (TLVs) that originally dated from 1946, as we discuss in Chapter 1, OELs became prominent in professional approaches to monitoring and controlling occupational exposures during the second half of the 20* century.4 Indeed, it could be argued that especially in North America and the UK, their understanding and use played a significant role in the development of the occupational hygiene profession.5 Although originally conceived as technical standards to be used as guidance for professional occupational hygienists, within in the EU such limits became increasingly incorporated into regulatory systems at national and EU level from the 1980s onwards. It is probable that there was a mixture of drivers behind this development. They would
According to Cook (1985 and 1987) the first 'official' list of OELs was issued by the USSR Ministry of Labour in 1930. See Piney (1989 and 1998) for a more detailed account of the interrelationship between the role of early OELs and the development of the occupational/industrial hygiene profession in the US and UK during the first half of the 10b century.
Limits 6 Beyond Limits have included the more structured and systematic approaches to regulating OHS management that began to emerge at national and European Community level during the 1980s, culminating in the Framework Directive 89/391 its daughter directives and the national measures that transpose them (Walters, 2002:41-47). Parallel approaches in relation to managing the risks of hazardous substances were emerging at national level (for example, the COSHH Regulations in the UK) and at EU level (such as the Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens and the Directive 98/24 on the protection of workers from the risks related to chemical agents at work). The demand for standards to control the use of a number of specific and highly toxic substances such as vinyl chloride, asbestos, benzene and lead in combination with the drive towards systematic management of OHS generally may have also fuelled the perceived need for greater systematicity in the regulation of the management of occupational exposure to hazardous substances. This may in turn have created pressure for a more developed regulatory role for OELs. At the same time that a number of European countries were setting up national bodies to set their own OELs instead of adopting the American list of TLVs produced by the ACGIH, European Community level institutions such as the Scientific Committee on Occupational Exposure Limits (SCOEL) were created with the intention to contribute to the process of setting OELs at EU level. The Chemical Agents Directive 98/24 and the Indicative Occupational Exposure Limit Value (IOELV) Directive made under it continued the institutionalisation of OELs within the legislative process, adding an international dimension to the pressure to incorporate OELs into regulatory systems. Incorporation of OELs into these systems however was not inevitable. It would seem that the decision making bodies internationally within Europe were desirous of adopting 'good occupational hygiene practice' in giving some regulatory significance to establishing the hierarchy of control practices referred to previously. Since OELs were fundamentally reference standards that were used by hygienists in exposure measurement they too would become part of the package of 'good occupational hygiene practice* that was being incorporated into regulatory systems. Additionally their incorporation seems also to have been driven by a desire to use numerical values to make judgements about risk and to guide practice in ways that may in hindsight appear, if not ill-considered, then at very least to underestimate the problems for risk communication that would be created by the need for a proper understanding of the meaning of such values.
Introduction 7 Somewhat paradoxically, by the time these developments were underway and 'good occupational hygiene practice* was achieving a level of regulatory incorporation that included a place for OELs, hygienists themselves were beginning seriously to question their value, as it was becoming more widespread knowledge that OELs were not without their limitations. As Hanson (1998:12) has observed, for a host of good reasons, there is in fact no reliable scientific basis for drawing a fine line between hazardous and non-hazardous concentrations of a toxic substance. Understanding the scientific meaning of an OEL and most importantly, its reliability as a measure of risk is therefore fundamental to its proper use. As we explore a little further in the following chapter, such an understanding requires a reasonably sophisticated appreciation of the scientific limitations of both the methodology for deriving OELs and the evidence on which they are based. In addition, as the prominence of OELs has increased, critics have pointed to serious shortcomings in both these fundamental elements in the derivation of such limits and the assumptions surrounding them, especially in relation to the most influential and widely used American ACGIH list of TLVs.6 The significance of these limitations of course becomes considerably more serious when they are incorporated into regulatory systems and this no doubt helped focus attention on them. In addition, a further set of doubts were growing, at least in some countries, concerning the practical use of OELs at the level of the workplace. To an extent these practical concerns were related to the complexities involved in understanding the meaning of OELs and thereby being able to use them in an informed and appropriate manner. However, they were also based on evidence emerging in the UK for example which indicated that despite them being quite central to the prevention principles that were the basis of regulatory measures such as the Control of Substances Hazardous to Health Regulations - they were in fact little understood by the majority of employers who were duty holders under the Regulations and required to implement their measures (HSE 1997). These developments and the debates that surround them were largely the reasons for undertaking the research project on which the following chapters are based. They raise some fundamental questions about the way in which OELs are understood by employers and workers and the use to which they are put in the practice of managing risks from Articles in the scientific literature in the late 1980s and early 1990s questioned the completeness of the evidence on which they were based and also pointed to corporate bias in the standard setting bias of the committee (Casteleman and Ziem 1988). See also Ziem and Castleman (1989) and Roach and Rappaport (1990).
Limits 8 Beyond Limits hazardous substances in European workplaces. Equally, they have implications for strategic decisions taken at national and sectoral levels about the role of OELs in regulating these practices. We explore these issues and assess their implications. There are indications of recent shifts in the function of OELs in regulatory strategies in some EU countries. We also examine the extent to which these changes reflect awareness of the possible limitations of the role of OELs in previous strategies and therefore represent more informed approaches. Fundamental to our approach, is the idea that such change cannot be understood in isolation from other aspects of regulating health and safety management in the EU. They are an integral part of this wider scenario and therefore affected by the pressures and constraints that have an impact upon it. The essential elements of current regulatory strategies aimed at the work environment in the EU - with their focus on employers' responsibilities for systematic OHS management through the adoption preventive principles in which risk evaluation and control in their workplaces are undertaken with the support, if necessary, of prevention services and through informing and consulting workers and their representatives - apply as much to managing the risks of hazardous substances as they do to all other aspects the work environment. Moreover, the same challenges to regulating the work environment in the modem world of work apply to hazardous substances as they do to regulating health and safety more generally. Any significant understanding of the strengths and weaknesses of role of OELs in managing health and safety regulation must be one that accounts for a world of work in which for example, a large proportion of work takes place in small enterprises where there is low trade union density and poor access to prevention services, as well as a very low likelihood of experiencing any proactive regulatory inspection visits. Such 'hard to reach' situations are by no means confined to small enterprises but are also found in what were formerly large organisations where the structure of work has become increasingly fragmented and where outsourcing, casualisation and the use of contractors and contractor labour on multi-employer worksites, all contribute challenges to the systematicity and penetration of management arrangements, especially where issues of information, communication and supervision are concerned. Arguably the relevance of approaches to using OELs in strategies to regulate the management of the risks of hazardous substances must account for the realities of the experiences of the most vulnerable workers in these situations if they are to be deemed to be effective. Relatedly, they need to take account of the levels of resourcing of regulatory inspection, the extent of effective worker consultation and representation, the presence and competence of prevention services in health and safety and the levels of use employers
Introduction 9 make of such services in supporting their approaches to managing the risks of hazardous substances in their workplaces. These are issues that we will examine in further detail in the chapters that deal with the approaches to setting and using OELs in the six countries that were the focus for detailed investigation. Our choice of these countries was based on several criteria as we outline in the following section.
THE COUNTRIES Resource constraints meant we could not study in detail all 15 countries that were member states of the EU at the time the fieldwork was undertaken. Countries were therefore selected on the basis of them providing a variety of national situations that reflected the full range of approaches used in relation to setting and using OELs - from highly developed OEL systems to minimal ones and therefore the range of different frameworks for the setting and use of OELs identified across all EU 15 countries. Our choice was also intended to be representative of the range of regulatory and socioeconomic systems in these countries and reflect some consideration of the size, complexity and economic importance of the countries. We selected: -
The UK - as the "benchmark' country in which there is a well-documented role for OELs within the regulatory system that has been subject to considerable and on-going reform in the light of experience. It is also a country in which the wider regulatory system for OHS reflects a particular approach to process regulation as well as to the use of more multidimensional approaches to regulatory intervention and one in which the strategy for reaching small enterprises is clearly articulated.
-
Sweden - as a representative Nordic country with advanced regulatory provisions for OHS and a long involvement in setting and using national OELs.
-
The Netherlands - because of the innovative approaches that appear to be in use in relation both to managing chemical risks and in OHS more widely. Also because in many respects it represents a hybrid of Nordic and Germanic approaches to labour relations and to regulating OHS (as well as being influenced by British pragmatism and the recommendations of the Robens Committee).
10 Beyond him its 10 Limits -
Germany - because of its size, economic importance and complexity, its dual system for OHS regulation, its approach to labour relations and its long history of setting and using exposure limits,
-
Italy - because it is a large and economically important southern European country with some unique regulatory features in its OHS system with interesting differences in approach to that of northern Europe. It also had a traditional approach to exposure standards that was different to that required under the Chemical Agents Directive.
-
Greece - as an example of a smaller and economically weaker southern European country with underdeveloped systems for the wider regulation of OHS as well as for setting and using OELs.
In each country we undertook to identify and review available literature, focusing on: -
-
issues in securing improved management of chemical health and safety, including: - perceptions of the problem - risk assessment - employer/worker awareness - securing compliance with OELs the status of controls for airborne exposures in each country degree to which such controls are applied measures used to achieve and monitor compliance and the extent of compliance itself.
It was anticipated that the literature would be rather limited in most countries and would not deal directly with many of these issues. This was indeed the case and other sources of information were sought including a number of key informants in each country. These informants were a mixture of regulatory agency personnel, trade union officials, industry spokespersons and specialist researchers/professionals, all of whom were considered to be well informed and well placed to comment on the realities of workplace practices. Their views were compared with documented policy as well as with existing literature on the issues under investigation in order to enhance and develop
Introduction 11
the picture of national practice. Specific information was sought from interviews concerning:7 -
theroleofOELs in determining what control measures were in use in OHS management at the workplace the extent to which reference was made to OELs in monitoring OHS management by the labour inspectorate what other measures were used in addition to or instead of OELs to determine control measures and good OHS management practice.
THE STRUCTURE OF THE BOOK Chapter 1 presents a brief overview of current understanding of occupational exposure to hazardous substances and its effects in terms of mortality and morbidity amongst workers. The role of chemicals in the economy and the extent of their production and use in the European Union are outlined before a discussion of the relevant key approaches to regulating health and safety health and safety management of hazardous substances in the European Union is presented. Since the book is concerned with their role in regulation, specific aspects of what OELs are and how they have developed and some key issues in understanding their meaning and appropriate use are explored. Their positions in current strategies to regulate chemical risk at European and national levels are outlined. Current issues for the use of OELs in the regulation of chemical risks emerge as a result and the chapter concludes with a discussion of their implications that sets the scene for the chapters that follow. In the original study on which this book is based, two substances were chosen for the main focus of the country studies. They were toluene and wood-dust, for which, all EU member states have exposure limits. It was intended that attention would be paid especially to sectors in which there was relevant experience of exposure to these substances and in which a reasonable range of workplace size, work processes and health and safety risks were represented. The main sectors where we thought it most likely we would find such things were the furniture industry, printing and metal manufacture. In practice, we found it necessary not to restrict the study to experiences associated only with these substances and sectors to explain and understand national approaches and a more general view of practice in relation to OELs was in feet sought. The present volume reflects this experience, however, some of the detailed examples of practices in relation to these two substances in the sectors mentioned have been retained.
12 Beyond him its 12 Limits
Chapter 2 is concerned the structures and procedures for setting and applying OELs at European level. It opens with a description of the development of the relevant EU provisions for regulating health and safety in relation to hazardous substances and describes the structures and procedures for setting OELs at the European level. It goes on to describe current changes taking place in regulatory policies on chemical substances, focusing especially on the proposals for new chemicals regulation known as REACH (Registration, Evaluation, Authorisation, of Chemicals), to Chapter 3 we turn to the regulatory provisions, institutions and procedures for setting OELs within the health and safety systems of each of the EU 15 member states. Chapters 4 to 9 detail these matters for the six countries listed above, to each country the mam focus concerns the practice of using OELs and is especially concerned with the role of OELs in regulating OHS management at the level of the enterprise. Each chapter therefore considers the role of OELs at the workplace level in each of the six countries. Using information from interviews with enforcement agencies, employers, trade unionists and other key stakeholders in each country, as well as documentary sources, the chapters offer a detailed analysis of strengths and weaknesses in the role of exposure limits in compliance strategies on chemical risk management at the workplace, to addition they report on a variety of current strategies that are undertaken in different countries to improve the management of the risks associated with working with hazardous chemicals and examine where OELs fit into these strategies. They discuss the practicability of these approaches, their application and coverage in relation to the emerging policies on chemical risks at national and international levels. In doing so they also take into account wider perspectives both in relation to perceptions of the value of OELs in managing chemical risks and in terms of structures and processes for OHS regulation more generally and the challenges they face. The national variations in these structures and processes are of direct relevance to the strategic significance or otherwise of OELs in the process of regulation and this significance cannot be appreciated fully without an understanding of the wider regulatory scenario. In Chapter 10, the concluding chapter, the information from the previous chapters is drawn together in a discussion in which the two themes of policy and practice that nm throughout the study are linked and the lessons that have been drawn from the analysis are presented.
13 13
THE PROBLEM OF CHEMICAL RISKS
INTRODUCTION In this Chapter we first present a brief outline of the role of chemicals in the economy of the European Union. We note the consequences of their use in terms of the effects of occupational exposure to hazardous substances on mortality and morbidity amongst workers. We then turn to a discussion of the relevant key approaches to regulating health and safety management of hazardous substances in the European Union. Since the book is concerned with the role of OELs in this regulation, the positions of OELs in current strategies to regulate chemical risk at European and national levels are outlined. This leads us to a reflection on some specific aspects of what OELs are and how they have developed and some key issues in understanding their meaning and appropriate use are identified and discussed. The chapter concludes with a discussion of the implications of these issues for the regulation of chemical risks that sets the scene for the chapters that follow.
CHEMICALS AT WORK IN THE EU According to the European Commission's White Paper on the strategy for a future chemicals policy, the global production of chemicals had increased from lmillion tonnes in 1930, to 400 million tones by the time the White Paper was published in 2001 (EC, 2001:4). The chemical industry in the EU produces about one third of total international chemical output and as such is collectively the largest chemical industry in the world, with an estimated turnover of some €556 billion in 2003 (for the EU 25 countries) (CEFIC 2004).
14 Beyond Limits 14
About 100,000 different chemical substances are registered in the EU, of which 10,000 are marketed in volumes of more than 10 tonnes and 20,000 marketed at volumes of between 1-10 tonnes. In 1998 world chemical production was estimated to be valued at €1,244 billion, of which the largest share (31 per cent) was produced by the EU chemical industry. It is Europe's third largest manufacturing industry, employing 1.7 million people directly with a further 3 million jobs dependent on it. Although large multinational corporations are prominent in the industry, in Europe there are also 36,000 SMEs (over 95 per cent of the total number of chemical firms in Europe) that between them are responsible for 28 per cent of chemical production (CEC 2001). The chemical industry itself is mainly concentrated in Germany, France, the UK and Italy. The largest share is in Germany with 26 per cent of total EU production, followed by France (17 per cent) the UK (14 per cent) and Italy (12 per cent). Chemical production is however only one aspect. The European Union remains the single largest market for the chemicals industry. Chemicals are used in vast numbers of workplaces across the whole spectrum of economic sectors, both private and public. In addition to the direct industrial users of chemicals supplied by their original manufacturers and importers, there are also formulators that use chemicals supplied by original manufacturers or importers in various combinations in their own products before marketing them to further users and there are distributors of these products as well as those of the original manufacturers and importers. There are several consequences of this for workers' health and safety and its regulation. First, it obviously means that the workers who may be at risk of exposure to hazardous chemicals will be found throughout the economy and not just amongst the employees of the chemical industry and its dependents. The most recent information provided by the series of surveys conducted by the European Foundation for the Improvement of Living and Working Conditions found that 22 per cent of respondents in the EU thought themselves to be exposed to dangerous substances for at least a quarter of their working time while sixteen percent thought they handled dangerous substances daily (European Foundation 2001). In an earlier study it was estimated that some 32 million workers in EU countries were exposed to occupational carcinogens (Kogevinas 1998) and there were between 35,000 to 45,000 per year.1 If these
As well as the direct products of the chemical industry occupational carcinogens identified in this estimation included environmental tobacco smoke, radon, diesel exhaust and crystalline silica. See also Finnish Institute for Occupational Health, 1998.
The Problem of Chemical Risks 15
experiences are typical for European workers generally it suggests that millions of workers across Europe as a whole are exposed to hazardous chemicals at work. Secondly, there is a huge gap in knowledge concerning the potential risks to human health associated with the enormous numbers of substances produced and marketed in the EU and only limited data on the exposure of large number of persons involved in using the substances and the situations in which they do so. Thirdly, the role of intermediaries in the downstream supply chain from manufacture to use contributes to the remoteness of some users from the original suppliers of the substances they are using. This may complicate, alter or obstruct the quality of information flow concerning safe use of chemical substances from supplier to end-user. Such potential effects on the consequent ability of users to use hazardous substances safely, therefore pose challenges for the chemical industry to fulfil its statutory obligations to the users of its products effectively and at the same time presents a problem for appropriate regulation.
MORTALITY, MORBIDITY AND OCCUPATIONAL EXPOSURE TO HAZARDOUS SUBSTANCES m EUROPE It has been estimated from EU aggregate data9 that nearly one third of all occupational diseases recognised annually in the EU are related to exposure to chemical substances (Musu 2004).10 Data on death and disease associated with occupational exposure to hazardous substances is available from a variety of sources such as those based on for example: -
National statutory reporting requirements for occupational diseases, injuries and fatalities Registries of specific conditions such as cancer, skin or respiratory diseases associated with occupational exposure Available from Occupational Diseases in Europe in 2001, Statistics in Focus, Population and Social Conditions No 15 Eurostat, 2004, http://eiiropa.eu.int/connn.eurostaP-Publications. A substantial proportion of these are caused by chemical dusts such as asbestos.
16 Beyond him its 16 Limits
— Household surveys of self-reported sickness absence — Epidemiologieal studies in relation to specific forms of ill-health and their occupational causes Despite the current widespread concern about the risks of hazardous substances in the workplace, there are considerable problems in defining the proportion of death and disease in society that can be accurately attributed to occupational exposure to hazardous substances. There are many reasons for the difficulties researchers have encountered in attempting such calculations. They include the limited completeness of officially reported data, which is often defined by laws that were put in place for reasons that are at odds with the collection of comprehensive data on occupational disease." Such data in some systems is known to under-report the occurrence of the conditions it records because of failure to report them on the part of duty-holders. There are national variations in the nature of what is required to be reported and in the administrative systems for recording it. These lead to further variation in the quality and comprehensiveness of the national data and make aggregation and consistency of such material problematic at a European level. There is often a time lag between exposure and onset of disease, which in some cases may be considerable and which means that the current information about health effects may, in fact, refer to exposures that took place at times in the past when such exposure may have been of a different character to that experienced at present. Other measures of the extent of the experience of ill-health may be derived from workers' own self-reporting such as undertaken in the Labour Force Survey in the UK for example. Such measures usually result in substantially larger estimations of the extent of work-related ill-health and may be useful in calculating time lost to economic production and burdens on the health care and social welfare systems, but as measures of the nature and extent of illhealth they are problematic for a number of other reasons to do with respondents' self-diagnosis and memory of their work experiences. Estimations of mortality and morbidity based on these sources or on extrapolations from specific studies are themselves also controversial in terms of the methodology adopted and the assumptions made about what is or is not included as indications of the extent of the harm being estimated, hi acknowledgement of such problems many current estimations provide lower and In some cases, such as in the UK for example such requirements have had more to do with limiting the number of claimants eligible for social welfare benefits than a desire to document the extent of a particular association between work and ill-health.
The Problem of Chemical Risks 17
higher limits to their figures according to the different elements of methodology and coverage in deriving them.12 Although detailed discussion of all these problems is beyond the scope of the present volume, the significance of the uncertainty to which they contribute is central to the strategic development of regulatory approaches to risk management of hazardous substances and the position of OELs in such processes. It is also central to a second important issue that current more systematic regulation of chemical substances at the EU level is attempting to cover - reducing the burden of mortality and morbidity associated with occupational exposure to chemicals whose health effects are little known and with situations in which exposure is unknown or unspecific. The approach of Doll and Peto (1981) to estimating the extent of mortality from cancer that is due to occupational causes has been the basis for several subsequent estimations.13 m one of the most recent of these, a study undertaken to inform the European Commission in its deliberations on current regulatory strategies on controlling hazardous chemicals, Postle et al (2003) estimate that 3.5 per cent of the total cancer mortality in the EU was associated with occupational exposure to chemicals and the authors suggest that about 20 per cent of such mortality may stem from exposure to currently unknown chemical carcinogens. Spokespersons for the chemicals industry have disputed these figures. They point out, amongst other things, that the authors of this study confuse the more general situation of working with hazardous substances with working with chemicals in the chemical industry. Based on evidence from large German chemical companies, they further argue that there is evidence to show that, in fact, measured exposure to carcinogens in large plants in the industry has declined (CEFIC 2003). On this basis they suggest that exposure to chemicals in similar plants in the industry is also likely to have declined and argue that this indicates the success of OHS management measures in the industry.14 "While these may be valid criticisms of the particular study undertaken by Postle et al for the European Such is the case in most of the sources referred to in subsequent paragraphs. However, in some cases the range between upper and lower limits is so great that such estimates are of limited practical use. See for example Kogeninas et al 1998; Morrell et al 1998; ILO 2000; Postle et al 2003. Also, more generally see Greenberg et al 2001; Leigh et al, 1999. See also Kromhout and Vermeulin (2000) for a more general discussion of long term trends in occupational exposure to hazardous substances.
18 Beyond him its 18 Limits
Commission, they do nothing to negate the wider evidence of the relationship between known hazardous substances and the extent of deaths from cancer, nor do they contradict the proposition that a substantial though unknown proportion of these deaths result from exposure to hazardous substances that are not yet identified as carcinogens. Cancer is by no means the only condition caused by exposure to hazardous substances. Other diseases, of the respiratory system, the skin and the central nervous system are also associated with such exposures, as are allergies and reproductive, developmental and endocrine disorders. They add up to a formidable burden of fatal and non-fatal illness caused by exposure to hazardous substances at the workplace. However, there are no reliable data concerning the full occurrence of such conditions on a European scale. Nor is there anything like complete data on exposure - although here again there are specific cases of very good exposure data-bases at national sectoral level.15 Although there are plenty of specific detailed studies that support both the idea that the health effects of occupational exposure to hazardous substances are substantial and a cause for concern, the full extent of this occupational exposure and its health consequences remains unknown. All this is a major challenge for regulatory strategies aimed at helping to reduce it. Indeed, if the logic of the argument applied by the chemical industry apologists outlined above is followed, the dimensions of the problem become apparent, for it is not the diminishing number of large chemical manufacturing firms that define its parameters. Rather, it is experiences of hazardous substances amongst users in the much larger and increasing numbers of small or fragmented workplaces in which sophisticated control measures such as those that result in reduced exposures in large chemicals firms are not in evidence and where contact with regulatory intervention is also unlikely. It is the reality of regulating the safe use of chemicals in this far more diverse environment that has exercised poEcy makers at national and European levels in recent years and it is to the role of exposure standards in this process that we will turn next. Before doing so however we need to say something about the nature of such standards.
Such as the database DOK.-MEGA run by the BGIA and the BGen in Germany for example - see Chapter 5).
The Problem of Chemical Risks 19
ISSUES FOR THE ROLE OF O E L S IN MANAGING WORK WITH CHEMICAL RISKS The main concern of this book is the role of OELs in the regulation of the risks of hazardous substances. Exposure limits are prescriptive standards in as much as they set specific requirements concerning the precise measures of particular substances that are allowed in the air of the workplace. They are based on scientific evidence concerning what is known about the biological effects of certain chemical substances combined with what is considered to be technically and economically feasible in achieving their control. Such standards are themselves not new. They had been used as technical guidance in occupational hygiene for several decades before being incorporated in the regulatory systems in many countries. However, incorporation gave them a different status to the one they held previously and at the same time has led to questions and concerns about their role. These concerns have become more prominent over the last decade as evidence questioning their usefulness within the system for regulating selfregulation has mounted, indicating the very limited degree to which duty holders understand them.16 Clearly, if many employers, especially those in small enterprises, do not know how to determine whether exposure levels in their workplaces comply with the relevant OELs, (or even that they should determine such matters) the role of limits, in the practice of managing the risks of hazardous substances at the workplace level, is open to question. Even more fundamental are questions concerning the meaning of OELs especially ones that address the extent to which they are misconceived to represent 'safe limits' by users. Such questions penetrate to the core of current thinking on risk communication and risk regulation. If the definition of the level of risk represented by an exposure limit for a 'hazardous substance' is prone to a misinterpretation concerning its meaning and limitations, then the whole system is also likely to suffer a loss of both sense and credibility in terms of risk communication. One of the major shifts that has occurred in public policy in In the UK the results of HSE commissioned research showed that only 16 per cent of a sample of respondents from establishments manufacturing or using chemicals mentioned complying with COSHH or OELs as legal requirements for work in such situations. They demonstrated an almost complete absence of detailed knowledge or understanding of the duties associated with OELs and Maximum Exposure Limits (MELs) (HSE 1997).
20 Beyond Limits
recent years has been the greater attention paid to societal perception of risk that has followed fiom the (somewhat belated) realisation that public perceptions of risk and especially of risk regulation are essential considerations if strategies on the governance of risk are to be successful. Following the catastrophic loss of public trust precipitated by governmental and 'expert' handling of issues such as nuclear power, BSE, foot and mouth disease and genetic manipulation, taking account of public trust has become a more significant aspect of regulation of risk in public policy. To do so, at very least, requires a participatory approach and a blend of clarity and transparency in both the decision-making processes and their end results. As well as the economic considerations that often affect whether substances have an OEL, there are also technical questions concerning problematic details such as the difficulties encountered in applying its criteria to certain substances, so that it is not possible to give them an OEL despite their known hazards. Such problems have contributed to a growing recognition of the need for reform. A further matter is the need for compatibility in standard setting procedures between EU Member States and procedures at the level of the EU. There are several reasons for this including the obvious requirement for general harmonisation in OHS regulation. More specifically, the question of the meaning of exposure limits, their toxicological basis and the issue of economic and technical feasibility of achieving best practice in the workplace have taxed regulators and practitioners for decades. There is consequently a history of standard setting structures, processes and outcomes at European level, the consequences of which policy makers and regulators are obliged to take account at national level. In the following section we sketch out some of these issues and provide some background to understanding the development of the role of OELs in chemical regulation. We begin with a brief outline of what occupational exposure limits are and how they have developed from scientific/technical standards to regulatory ones. In doing this we also consider some of the key issues that have exercised participants in the process of setting limits and in particular, questions of technical and economic feasibility that lie at the core of many of the debates surrounding regulating the risks of chemical substances. This leads to consideration of some relevant aspects of the relationship between societal risk perception and regulating the management of hazardous chemicals at work. Finally, we draw these various threads together by returning to the likely role of OELs in modern European
The Problem of Chemical Risks 21
approaches to regulating the management of hazardous chemicals at the workplace and the policy questions for regulating the (systematic) management of workplace chemical risks in the EU.
WHAT ARE OCCUPATIONAL EXPOSURE LIMITS AND HOW HAVE THEY DEVELOPED? Occupational exposure limits for airborne concentrations of hazardous substances are essentially measurable values of airborne (and therefore breathable) contamination by chemical substances that are points of reference for the development of workplace strategies to protect workers from health risks associated with inhalation of chemical substances. Beyond this general definition lie a number of levels of complexity and contradiction. Exposure limits have been proposed by individual researchers for particular substances and classes of substances since the late 19th and early 20th centuries (Hanson 1998). Several lists were published in Europe and the US in the 1920s and 1930s but the most influential was that of the American Conference of Governmental Hygienists (ACGIH) which published its first TLVs in 1946. The list was adopted by the US federal government as its official standard in 1969. Although from the outset certain other countries such as the USSR and the Federal Republic of Germany have determined their own limits, the dominant role that the ACGIH TLVs have played as a reference list for exposure standards in industrialised countries is well documented," The development of single figure exposure limits such as were found in the ACGIH list has been well described by Piney (1998) who applies Kuhn's (1970) theoretical explanation of the role of the paradigm concept in scientific communities to trace the development of TLVs in the US. He suggests that in the 1940s the history of science-based exposure standard setting, which until then could be characterised as being in a (pre-scientific) pre-paradigmatic stage, changed into a (scientific) paradigmatic period that was shared by both the See for example, Cook 1985, Hanson 1998, Mendeloff 1988, Piney 1998, Stokinger 1984, 1988 and Ziem and Castleman 1988 for accounts of the history of the development and use of TLVs.
22 Beyond Limits
science-based professions of industrial hygiene and industrial toxicology.18 Fundamental to this approach was the notion that it was theoretically possible to prevent risks to health through a combination of industrial toxicology and occupational hygiene that could quantify exposure levels of hazardous substances in workplace atmospheres with an exactness that would enable distinguishing between those atmospheres in which there was no risk to health and those in which levels of contamination with hazardous chemicals posed a threat. Unfortunately, reality has proved to be more complicated than this. While the approach and the ACGIH TLV list itself have been enormously influential in industrialised countries worldwide, for many reasons, it is an approach now recognised to have considerable flaws. From the 1970s, other countries, notably those in the EU, began to develop their own lists, although the influence of the ACGIH list was still widely felt in these separate national approaches. It is generally acknowledged that the TLV list is the most widely circulated and significant set of exposure standards in the industrialised world and its formal and informal influence on various national policies and practice is considerable, as is evident in most of the countries we studied. Germany's limits (Maximale Arbeitsplatzkonzentmtionen — MAKs) have developed separately from ACGIH and are said to be based exclusively on scientific information about health effects. Its documentation states that 'scientific criteria for the prevention of adverse effects on health are decisive, not technical
What this means essentially is that prior to the 1940s several approaches to exposure standards can be traced, in particular the use of specification standards in which controls were specified but control effectiveness was not The development of the profession of industrial hygiene was strongly linked to the measurement of the effectiveness of controls and hence to the use of exposure standards. Combined with the professional concerns of industrial toxicology (health effects of exposures) such standards could be used to achieve (theoretically) risk free atmospheres. Thus the paradigm of single value exposure limits was a powerful binding notion for the two science-based professions to develop a truly preventive approach to preventing damage to workers' health. While acknowledging oversimplification (which does not account for the criticism of the OEL paradigm from within the industrial hygiene community), this explanation of the mutually reinforcing growth of the profession of occupational hygiene and that of the status of the TLV list is nevertheless persuasive (see also Piney 1989).
The Problem of Chemical Risks 23
or economical feasibility'.19 Carcinogens and genotoxic substances are given TRK values because it is accepted that such limits cannot be based exclusively on health considerations.20 However, since 1 January 2005, technically based TRK values have been replaced by a new type of value (Arbeitsplatzrichtwerte or ARWs) which is not any longer health but risk based. The consequences of this will be discussed in more detail in Chapter 5 on Germany. There is no longer any explicit influence of the ACGIH on the development of exposure limits although they were used historically. In Greece, occupational exposure limits are a relatively late addition to national regulation of occupational health and safety. There is an agreement between the Greek national health and safety institute (ELINYAE) and the ACGIH and since 1997 the latter's list is translated and published in Greece. Italy has a history of not including limit values in national legislation, preferring a general requirement on employers to reduce levels of workers' exposure to as low as is technically feasible.11 However, certain collective agreements such as for example the one that exists in the chemical industry provides for the adoption of the exposure limits in the ACGIH list. Since such agreements have legal status in Italy this means that the standards in the list are also legally binding. In the Netherlands until 1977, the ACGIH TLV list was used. The first official Dutch list of MACs was published in 1978 but it consisted largely of the ACGIH TLV list of 1977. Since then, new MACs and changes in existing MACs have been established according to a procedure which separates evidence on health effects from issues of economic and technical feasibility. However a large number of current OELs remain those adopted from the ACGIH list of (around 300 such substances are currently under review).22 See Senatskommission 1996:9. "The present theory of chemical carcinogenesis indicates that even the lowest doses will produce some genotoxic damage irrespective if the observation or non-observation of tumour formation in finite experimental conditions" (Henschler 1991:15 quoted in Hanson 1998:37). But implementation of the IOELV Directive clearly changes this. A similar situation exists in the UK. where something like 350 substances have an OES that is unchanged since the last TLV list of 1980 and have not been assessed by the ACTS/WATCH committee to see if the OBS criteria are met.
24 Beyond Limits
Sweden also has had its own system since 1969 - although the list issued at this time was based almost entirely on the TLVs of the ACGIH. Since 1978 it has made a concerted effort to separate the decision-making processes dealing with scientific issues concerning the health effects of chemicals from those that deal with economic and technical feasibility. This has had an effect of gradually reducing the levels of exposure limits. According to Hanson (1998) there has been a 3.9 per cent average yearly reduction of the values of exposure limits overall, a 5 percent reduction for solvents and a 10 per cent reduction for carcinogens, generally giving Sweden the lowest limit values in Europe. In the UK the ACGIH list of TLVs was the basis for exposure limits until the 1980s when a UK provision of control limits and exposure standards was developed and incorporated into the regulatory approach encompassed by the Control of Substances Hazardous to Health (COSHH) Regulations. Despite this British regulatory position however, the majority of the limits adopted remained unchanged from those of the ACGIH list of TLVs. Discussion on exposure limits at EU level was an inevitable development of Directives intended to address the control of hazardous chemical agents that made their appearance during the 1970s and 1980s.23 Stemming from such legislative actions came moves towards setting European exposure limits during the 1990s. Reflecting national concerns about the meaning of exposure limits, debate about the scientific basis and meaning of limit values (see below) was a central feature, hi the following chapter we examine the extent to which national structures and processes reflect these requirements and their legal status. In subsequent chapters we look in greater detail at the effects of these regulatory systems and strategies to improve the management of occupational health and safety for hazardous For example, in 1974 the European Council initiated a Social Action Programme that included specific reference to health and safety. It led to new Directives on safety signs, and vinyl chloride monomer. In 1978 the first Action Programme specifically on health and safety was announced. The most significant legislation made under this programme was a framework Directive on the control of chemical physical and biological agents at work, (Directive 80/1107/EEC, later amended by Directive 88/642/EEC). There were further directives on asbestos, lead and noise. Outcomes that were achieved at this level had a significant impact within Member States, where the approach of the directives towards the assessment of risk, was arguably an influence on the development of national strategies in the UK on the control of substances hazardous to health.
The Problem of Chemical Risks 25
substances. Before doing this we outline some of the debates and issues surrounding the application of OELs in the regulation of risk management of hazardous substances.
THE MEANING AND USE OF EXPOSURE LIMITS OELs have moved from the domain of occupational hygiene and industrial toxicology, where they were originally conceived essentially as reference materials for specialists involved in monitoring occupational exposures to hazardous chemicals, to legally enforceable limits that feature in regulatory strategies. This has meant that the key issues involved in understanding the meaning and use of OELs, have both increased in significance and altered in nature. Such issues are critical aspects that influence the development of policies on OELs and in the user and public understanding of such policies. The predominant ways in which these changes have been interpreted and applied in different countries has helped to shape the way that OELs are perceived, valued and used. An outline of the general background to some of the key issues of meaning and application of OELs is therefore relevant. Health based values and what is technically feasible. Recent discourse on the OELs that are used in practice in the countries of the EU, goes to some lengths to be clear that they do not represent 'safe levels' of exposure for all workers, nor is it intended that they should set a limit below which it is unnecessary or undesirable to reduce exposures further. The Scientific Committee on Occupational Exposure Limits (SCOEL) is quite clear about this, stating for example: "It should however be emphasised that it is always prudent to reduce exposure as far below OELs as can reasonably be achieved, in order to provide the greatest degree of health protection" The introduction to the ACGIH TLV list explains that TLVs are intended for use in the practice of industrial hygiene, they do not represent fine lines between safe and dangerous concentrations of hazardous chemicals. However, the originators of the list were confident that TLVs would protect the majority of workers from harm and they have been thus extensively promulgated as essentially safe levels
26 Beyond Limits
of exposure under which "nearly all workers may he repeatedly exposed, day after day, without adverse health effects. "M There are a number of well-documented reasons to believe that it is a fundamental misconception to regard TLVs as 'safe levels'. The evidence on which they are based has in many cases been shown to be alarmingly incomplete. Historically it has been reliant on a substantial amount of unpublished (and unevaluated) corporate information, and the ACGIH committee itself has been accused of being prone to corporate bias (Castleman and Ziem 1988). Since TLVs are intended to protect 'normal' workers but not those that may be particularly sensitive to chemical exposures, it is clear that 'normality' excludes a substantial proportion of workers. Perhaps most tellingly, harmful effects at levels below TLVs are easily found in the ACGIH's own documentation (Roach and Rappaport 1990), as well as elsewhere in the scientific literature and (Ziem and Castleman 1989), One reason why the US ACGIH system attracted so much criticism once it took on a degree of federal regulatory significance, is the considerable blurring in its approach between the procedure used to derive a so called 'health based' standard and the question of technical and economic feasibility.25 Modem civil society demands far more clarity and transparency on issues of risk assessment than was evident in the ACGIH procedures which, at best, could be described as a form of expert risk assessment in which the expert's own socially constructed assumptions about risk (that is those influenced by their own social as well as scientific experiences) remained unquestioned and at worst, a system in which key economic considerations of industry covertly determined levels that purported to be scientifically derived health based standards. Once OELs started to play a role in regulatory policies, European policy makers attempted to avoid this confusion Quoted from the preamble to the TLV List still appearing in the 1990s (ACGIH 1996: 3, in Hanson 1998: 21). Technical and economic feasibility are terms that appear frequently in the literature qualiflying and explaining the setting of OELs. Within a UK context the terms largely equate with notions of reasonable practicability such as defined by British case-law. Where technical feasibility appears alone it might appear to mean something that could be technically possible to achieve without regard to cost. However in practice, it is seldom used to mean this as it is almost impossible to distinguish something that is technically feasible from consideration of the costs involved in its technical achievement. We have therefore tried to reflect this by using the term "technically and economically feasible wherever possible.
The Problem of Chemical Risks 27
by creating clearer demarcations between the procedures that deal with the science of deriving a health-based limit and those that deal with setting a value that is believed to technically and economically achievable. The first of these procedures involves the scientific assessment of evidence of the harmful effects of a substance, undertaken by persons judged to possess the scientific competence to do so. The second engages the involvement of stakeholders in debate about the extent to which it is possible to agree measures to protect workers, that are at the same time economically and technically feasible to implement in the workplaces affected. One size fits all and the 'dirty end'. Different processes (and sometimes industries) cause different distributions of exposure. The major problem for standard setters in setting single all encompassing figures as limits is how to deal with those processes (industries) causing the greatest exposure. If single level exposure limits are set to accommodate, for example, a powerful lobby from a particular branch of industry that argues it is not economically or technically feasible to reduce exposure below a certain point in that industry, the same OEL is likely to apply to exposures in other industrial sectors, even though in such sectors it may be technically and economically possible to reduce levels of exposure to well below this OEL. Critics of existing OEL systems point out that in many cases it is the so-called 'dirty end' of industry (i.e. the sector of industry in which exposures are greatest and most difficult to control) that in fact plays a powerful role in determining the value that is eventually agreed to be economically and technically feasible, despite this sector of industry only accounting for the exposure of a relative minority of workers. While it may be argued that there is nothing that prevents the rest of industry reducing the level of exposure to as low as possible below the OEL, and in many cases regulatory agencies recommend building safety factors into the use of the limits (such as working to a percentage of the value that represents the actual limit), the message that is conveyed by the legal status of the limit is that employers are only required to do as much as is necessary to demonstrate they are within it. There is often no legal incentive to do more than this. Since exposure limits do not represent safe levels for the health of workers, this approach potentially has the effect of unnecessarily increasing the risks faced by the majority of workers to suit the technical and economic needs of a minority of employers in parts of industry in which exposures are greatest. Participatory approaches to standard setting. The European approach is also a product of a regulatory strategy for occupational risks in which an orientation
28 Beyond Limits
towards process regulation has been a feature characterising regulatory systems for OHS in northern European countries since the 1970s. This is especially the case in the Netherlands, the UK and in Scandinavian countries, but latterly it is also true more generally across the EU, as EU Directives based on this approach are implemented and operationalised in all EU countries. In efforts to 'regulate the self regulation' of risks at work the characteristic elements of defining the extent of employers' duties, information and consultation rights for workers and levels of competence for support services are (more recently) coupled with measures to ensure that the management of risks is undertaken in a manner in which employers discharge their duties competently (with the assistance of competent prevention services for example), systematically (by integrating OHS management into the core management of the enterprise and through assessing and controlling the risks of their activities) and involving workers and their representatives in participative approaches to OHS management. At the sectoral and national levels, risk assessment and control is also largely envisaged as a participatory process in which stakeholders, primarily employers and trade union representatives, (that is, those that 'create the risks and those that work with them'),26 engage with representatives of regulatory bodies in both developing and implementing strategies of risk assessment and control. The means and structures by which OELs are discussed and defined are part of this approach and are therefore probably better understood as an aspect of this wider development rather than as unique structures and procedures for dealing with the regulation of chemical risks. Chemical hazards and 'risk society'; OELs, the social construction of risk and risk communication. Whatever the infrastructural context of OELs-in-the-making, the importance of the status, clarity and transparency of the decision-making involved has become fundamental in societies in which concepts of risk, governmental roles and responsibilities in its regulation and accountability of duty holders to the public have all gained increased prominence. In the 'risk society* described by social analysts of late modernity" it is often the 'invisible risks' of life that characterise societal concerns. Issues of trust and public understanding of the scientific reasoning behind decision-making in environmental matters have become such that regulators and decision-makers have been forced to rethink their approaches to risk analysis and take both public perceptions of their activities and To paraphrase the words of one of the significant harbingers of this system, Lord Alfred Robens (Robens 1972). See especially Beck (1992).
The Problem of Chemical Risks 29
public engagement with them more seriously. The political consequences of not doing so have been shown to be of sufficient significance to force governmental policy makers to give at least some consideration of the notion that expert risk analysis is itself not free from social constructions of reality and to move towards systems for decision-making on public policy on risk regulation in which such considerations can be addressed. Debate on the relationship between regulation and risk has burgeoned in recent years and discourse has become increasingly sophisticated as analysis of the subject has deepened.28 As Hutter elaborates, regulation is a form of control in which risk itself is not prohibited, rather it is an attempt to manage it, in which structures, routines and procedures are constituted 'which will be incorporated into organisational routines and also become part of everyday individual activity. Where this fails the law can intervene through more overt forms of control, notably external regulation and sanctions.' (Hutter 2001:5). In the case of OELs, what this seems to mean is that the participants in the processes of setting limits and the information generated as a result of the process should be more representative of users as well as experts. They should be clear that what is being set by their contribution to the process, is not a 'safe limit' but rather a tool in the assessment and management of risk, which, if it properly applied should contribute to more effective and systematic management of health and safety in the use of hazardous chemicals. Unfortunately (even if this were true) it does not necessarily follow that actual users of OELs will be in the same position. Indeed, one of the most significant problems with the current British system for example, is the considerable absence of understanding amongst employers and managers, especially in smaller firms, about OELs and how to comply with them (HSC 2002:19) coupled with a widely held belief that they are See for example, Ayres and Braithewaite 1992, Gunningham and Johnstone 1999, Hutter, 1997 and Hutter 1999, in relation to the development of regulation on occupational health and safety and the environment. More generally see Colebateh 1989, Bardach and Kagan 1982, Hancher and Moran 1989 and Selznick 1980 for the theoretical analysis of the role and meaning of regulation in advanced industrial societies. See Ericson and Haggarty on the relationship between risk and regulation, Jaasanoff et al 1995, Nelkin 1992 and Wynne 1994 and 1996 on the relationship between risk and science and for a more specific attempt to relate the theoretical analyses of risk and regulation to occupational health and safety management see Hutter 2001:2 -23.
30 Beyond Limits
"safe' limits. As the HSC points out this latter view is probably reinforced by the fact that once a limit has been met the employer has fulfilled his/her legal obligations. As we shall see, such problems are also much in evidence in systems that do not share either the particular history or the features of the present British approach. While it may be that some of these problems of user understanding could in practice be tempered by a revision of the system to include a clearer obligations on employers to reduce risks to as low as technically feasible below the OEL for example, it is far from certain that they would dispel the myth that the OEL represents a safe level. A much broader question which also needs to be asked is: to what extent has the introduction of a system of limit values with the legitimacy of legality, contributed to the development of totemic significance for the notion of a numerical value that can delimit one state such as safety from another, such as danger, in the use of hazardous chemicals. Clearly, if this is the case it is part of a much wider problem of perception in which the notion of measurement implies the existence of numerical values that can distinguish precisely between one such state and another. This is a misrepresentation of reality, but one likely to require widespread re-education and policy reorientation to dispel. The extent to which these issues are a feature of national systems in Europe and to what extent alternative conceptualisations occur are questions to which we will return in the final chapter.
NEW DIRECTIONS IN REGULATING RISK MANAGEMENT OF HAZARDOUS SUBSTANCES AND THE ROLE OF O E L S It is important to consider the development of the role of OELs in regulation in relation to the evolving features of current approaches to regulating the management of hazardous substances at work more generally in EU member states. Although they differ in the details of their systems for regulating OHS, since the adoption and transposition of the Framework Directive 89/391, most EU 15 countries have a broadly similar approach to regulating the process of managing health and safety (Walters 2002). Their regulatory requirements aim to provide a structure within which employers and workers can be encouraged towards achieving self-regulation of the risks of their workplaces. As one observer of the development of this international trend in the regulation of the working
The Problem of Chemical Risks 31
environment has put it, they are measures that aim to regulate self-regulation.19 These frameworks provide structures and processes applied to the management of all hazardous chemical substances at work, as well as dealing with specific substances such as lead, benzene, and named carcinogenic substances. OELs feature in both. Indeed, if OELs were not already incorporated into these regulatory systems, the adoption by the European Community of the Chemical Agents Directive and its first Indicative Occupational Exposure Limit Value (IOELV) daughter directive and their transposition into national requirements should have brought this about in all Member States. At the workplace level OELs are standards against which employers can measure the extent to which their risk management strategies are controlling the occupational exposure of workers to airborne hazardous substances. However, the extent to which employers undertake the fundamental health and safety management procedures such as risk assessment in relation to chemical as well as other hazards has been shown to be far from universally complete. It has for example been shown to be, inversely proportional to the size of the enterprises for which they are responsible. This has been demonstrated in a wide range of studies concerning the implementation of the measures of the Framework Directive 89/391 .M Additionally however - and as we document in greater detail in the following chapter - despite the many measures aimed at controlling the risks of chemical substances in Europe, gaps in coverage and limitations in orientation have become increasingly apparent. For example there is a general lack of knowledge about the properties and uses of existing chemical substances.31 There is little information concerning the scale of use or levels of exposure occurring to downstream users of such substances and only limited information on the extent and detail of associated ill-effects. Nor do we know the most effective ways in which such ill effects can be prevented or reduced in practice in the complex work environments in which they occur.
See Ayres and Braithewaite (1992). For a more recent discussion of this point see Walters (ed) 2002:271-275. See Walters 2001 for a review of such evidence. Traditionally the regulation of chemicals in the EU has distinguished between new substances for which there have been quite detailed provisions concerning the assessment of the risks they pose to human health and the existing substances that make up the vast majority of chemicals used in European workplace for which no such provisions exist.
32 Beyond Limits
At the present time therefore a further dimension to regulating risk management in relation to chemical substances is in the process of unfolding as renewed efforts are being made to provide a more comprehensive approach to regulating risk and to deal with some of the complexities and uncertainties outlined above. At its core is an effort to adopt a more holistic view of the role of regulatory intervention in relation to working with hazardous substances and it is important to understand the role perceived for OELs in these emerging regulatory strategies, as well as in existing approaches to regulating systematic OHS management. The White Paper heralding the introduction of the REACH principles made this clear. In 1998 following concerns expressed by the Council of Environment Ministers, the Commission undertook an assessment of the operation of the four main legal instruments regulating safe use of chemicals in the European Community.32 Its report and the consultation that followed pointed towards the piecemeal approach of existing regulatory policy, noting the distinction in its approach towards the large number of 'existing substances', for which there was little information concerning their properties and use, and the much smaller number of 'new substances' for which more thorough information was available. It noted the slowness and resource intensiveness of the risk assessment processes in relation to substances as well as the inappropriate distribution of responsibilities involved - with too much focus on the responsibilities of the authorities and not enough on those of enterprises producing importing and using substances - leading to poor quality of information on use of chemicals and its consequences, especially in relation to downstream users. It found that existing regimes in place to address the liability of duty holders for damage caused by chemical substances were inappropriate and insufficient to provide effective remedies because of their emphasis on the need for causal connections that in practice were impossible to establish because of the remoteness of the parties concerned (CEC 2001). For the Commission the solution was to propose the new regulatory strategy announced in its White Paper. Prominent amongst the principle elements of the new approach encapsulated in REACH is the aim to achieve realignment of the responsibilities of duty-holders for ensuring the safe use of chemical substances in Council Directive 67/548/EEC and Directive 88/379/EEC, on classification, packaging and labelling of dangerous substances and preparatins; Directive 76/769/EEC restricting the marketing and use of certain dangerous substances and preparations and Council Regulation 793/93 on the evaluation and control of risks of existing substances.
The Problem of Chemical Risks 33
ways that encourage a more joined-up approach through influencing supply chain relations and promoting product stewardship, covering the full range of manufacturers, suppliers and users involved with chemical hazards. Additionally, through the same broad framework of realigned responsibilities, the strategy encompassed the regulation of chemical hazards in relation to the wider environment. A detailed description of the provisions foreseen under REACH (at least as it was foreseen in the proposal presented by the Commission in October 2003) will be provided in the next chapter. In the context of the present discussion it is worth noting that REACH intends to establish a system which will trigger different testing requirements based on the annual production or imported volume of a substance (independent whether of being a new or an existing substance) before the substance can be marketed in Europe. In a nutshell that means that the higher the amount of a substance, the higher the test requirements. However, the whole system will only start from a production / import volume of above 1 tonne and the test requirements for substances produced / imported between 1 and 10 tonnes per year are less severe than those currently applied for new substances of the same intended production volume. With respect to setting OELs for substances which do not have a limit value assigned so far, these distinctions are important because the test requirements for the lower tonnage are very limited. Only physio-chemical data33; on skin and eye irritation, skin corrosion and skin sensitisation, one in vitro mutagenicity test and basic environmental tests will be required for these substances (which are assumed to represent two thirds of the total number of substances) which will fall under the scope of REACH. There is however agreement about the fact that a minimum of data must be available to derive health based OELs (which should be in any case the basis for an OELs, even if technical and economical feasibility factors are taken into account afterwards). This minimum set of data comprises the above mentioned physical and chemical data, but also data on acute, subchronic and chronic toxicity using different exposure routes (via inhalation, dermal, oral). If available, genotoxic data, sensitising properties, reprotoxic data should also be taken into consideration. If the available data allows to derive a socalled NOAEL (a no adverse effect level), then a threshold or limit value can be Melting and freezing point, boiling point, vapour pressure, water solubility, flammability etc.
34 Beyond Limits
arrived at. This is the procedure used for effects which normally only occur above a certain concentration or in other words for substances which do not have an adverse effect on human health below a certain concentration.34 This means that the data set required for substances between 1 and 10 tonnes will not be enough to derive OELs. However, REACH will at least generate some data for substances for which no data is publicly available today." Even if this data might not necessarily be usable for establishing OELs, it will nevertheless be helpful in providing information concerning the risks of substances to be used in European workplaces. What is even more important with respect to OELs and workers' protection is that for all substances produced / imported in quantities above 10 tonnes so-called Chemical Safety Reports (CSR) will be obligatory. A CSR will be based on a Chemical Safety Assessment and contain a description of the manufacturer's or importer's exposure scenario(s), (including exposure scenario(s) they recommended to be implemented) for the identified use(s) of the substance in question. The exposure scenarios contain a description of the risk management measures which the manufacturer or importer has implemented and recommends to be implemented by downstream users. If the substance is placed on the market, these exposure scenarios including the risk management measures shall be summarised in an annex to the safety data sheet. This will provide downstream users in particular with more targeted information with respect to the intended uses and this is, for most substances, far more information than is currently available to users. So in theory, the new system will improve the situation at the work place.36 However, as we discuss in the final chapter of this book, regulatory provisions require proper implementation and surveillance. As we shall see, experience with existing legislation has not been encouraging in this respect.
For other effects like carcinogeniciry such a threshold does not exist. For those substances if considered to be not substitutable for the time being - risk based limit values are established, taking technical and economical feasibility into account. And this is the majority of substances used in Europe. 'In theory' also because at the time of writing, the final version of REACH had not been decided and there remains the possibility of further changes being made.
The Problem of Chemical Risks 35
CONCLUSIONS: BUT WHAT ABOUT USING OELS? Despite some success at reducing measured exposure in large chemical plants through introducing more systematic approaches to risk management, it seems clear that the scale of the problem represented by the quantity and range of chemical substances in use as well as by the variety of situations in which they are used remains formidable. There are major challenges for the control of prevention in relation to known health effects of hazardous substances, arguably even greater obstacles represented by the uncertainties about the health effects of large numbers of substances in current use and concerning the ways in which they are used. Therefore the challenge for regulation of risks associated with the use of hazardous substances at work in the European Union continues to be significant. Systematicity of risk management strategies in relation to hazardous substances requires good quality information concerning their health effects and the extent and nature of their use as well as on the economic implications of control. Generating OELs is part of this process and they have been agreed for a limited number of chemical substances. In this chapter we have summarised some of the issues of meaning and usage that have beset the processes involved in reaching agreement in setting OELs, especially since they have assumed a form of regulatory status. We have further outlined the role perceived for OELs in chemical risk management at the workplace level, both in the regulatory approaches towards systematic OHS management that have been the leitmotif'of the EU approach since the early 1990s and also in the newer and more holistic approaches that are aspired to by current EU approaches to regulating chemical risks. In all of this we find a wealth of material analysing the origins, development and status of occupational exposure limits. There is also much critical discussion of the reliability of the evidence on which different kinds of exposure limits have been set as well as what they actually mean in terms of protecting workers' health. It is beyond the scope of the present chapter to present anything more than an outline of some of the salient aspects of this material. Similarly, there is a substantial field of literature dealing with approaches to regulating risks in society, dealing inter alia with assessing risks, the social construction of risk and risk communication, all of which are relevant to strategies on setting exposure limits. There is also a growing literature on changing approaches to regulation of
36 Beyond Limits
the occupational environment. Again we have outlined a few of the relevant issues from these fields that have a bearing on our interests in occupational exposure limits. However, while there is an abundance of material that considers the issues surrounding OELs at the level of their making, status and meaning, the same cannot be said about literature that analyses their use at the workplace. Indeed, matters such as how OELs are actually used (or if they are actually used) are conspicuously absent from the extensive literature on OELs and on the management of chemical hazards generally. It is disconcerting to discover that such limited attention appears to have been devoted to what is actually done in practice with OELs following the extensive debate that has taken place concerning their status and meaning. This is especially so given that what little information that does exist suggests that at least in the UK there are a majority of employers who neither understand their meaning nor use OELs appropriately, despite being significant users of chemicals in their work operations (HSE, 1997; Piney, 2001). It was with these limitations in mind that we set out to explore the practices at the workplace level to which the remainder of this book is largely devoted. First however it is important to outline in more detail the main existing European legislation addressing dangerous substances in general and the structures and processes for setting and using OELs at EU and national levels as well as the regulatory contexts in which they operate in the various EU 15 countries. These are the subjects of the following two chapters.
37
EXPOSURE LIMITS AND INSTITUTIONAL STRUCTURES FOR HAZARDOUS SUBSTANCE REGULATION IN THE EUROPEAN UNION.
INTRODUCTION In this chapter an overview is presented of the various structures that have developed at European Union level in which OELs are determined and used in the process of regulating chemical risk management. Its aim is to provide the reader with some understanding of the regulatory context for OELs at this level and their role as instruments in regulatory strategy for risk management of hazardous substances. To do so first requires an account of relevant EU legislative arrangements that provide the legal framework within which chemical risk management operates, as well as information on particular provisions relating to the specific status and role of OELs. In addition information is necessary on the EU structures and processes involved in setting OELs. This makes for the presentation of a complex legal and institutional story. To facilitate it, while at the same time providing a route map to aid readers' understanding of the key issues that relate to setting and using exposure limits and the dynamics of their development at this level, the focus of the chapter is more concerned with the rationale behind the regulation of chemical hazards than with its detailed requirements. It begins with an account of the logic behind the array of Community level provisions that make up the legislative framework in which the protection of workers' health and safety from damaging workplace exposure to
3 8 Beyond Limits him its 38
chemical and biological agents is currently embedded. It includes an indication of the relationship between instruments relating to the control of risks from chemical and biological substances and those dealing with risk management at the workplace more generally. Following this outline, the chapter focuses on the position of exposure limits within the framework for regulating chemicals. Again, it is necessary to understand a little of the situation in previous times if the current position is to be properly appreciated. The existence of key institutions at EU level are outlined and their past and present roles in establishing OELs explained before some of the features of the documentation of exposure limits are described. On-going change in policy development behind the whole framework for regulating risk from hazardous chemicals however, means that not only is it important to describe its historical underpinnings and the relationships between instruments in the existing system but it is also necessary to note some of the major changes currently under discussion in this field, whose outcomes may have implications for the future determination and use of exposure limits. A brief account is therefore included concerning the identified weaknesses in the existing system and the rationale behind the current proposals on the development of the integrated system of chemical regulation, the elements of which - (Registration, (Evaluation and (Authorisation of (CH)emicals - have given rise to the now well known acronym REACH that is the subject of widespread current international debate.
EU LEGISLATIVE FRAMEWORKS FOR MINIMISING HEALTH AND SAFETY RISKS OF DANGEROUS SUBSTANCES Existing EU health and safety legislation aims at minimising the health risks from dangerous substances in the workplace. The control measures to protect workers focus on principles of elimination and substitution. The most important pieces of European legislation in this field are listed below where they have been separated into two broad groups - those generally concerned with requirements on the producers of chemicals and those mat are more specifically related to the workplace. Their requirements represent the three main European methods for dealing with chemical risks, through hazard identification, risk assessment and in a final step, risk reduction. As we have pointed out elsewhere in this book, in terms of their operation at the workplace level all these measures also need to be understood in relation to the
Exposure Limits in in the the EU EU 39 broad requirements of the Framework Directive, 89/391 which although it does not deal with hazardous substances directly, contains the basic provisions for managing health and safety at work generally, thus providing the regulatory context into which all specific provisions on managing particular risks fit including those from using chemical substances.
Important Directives with special significance for the protection of workers: Directive 98/24/EC37 on the protection of the health and safety of workers from the risks related to chemical agents at work Directive 04/97/EEC38 as amended on the protection of workers from the risks related to exposure to carcinogens at work Directive 2000/54/EC39 as amended on the protection of workers from risks related to exposure to biological agents at work. Other important pieces of European legislation on controlling trade in chemicals that contribute to the framework for regulating chemical risks in the EU: Directive 67/548/EEC40 and Directive 1999/45/EC4' on the classification and labelling of dangerous substances and preparations and their adaptations to technical progress
Council Directive 98/24/EC of 7 April 1998 cm the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC). Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (codified version) (Text with EEA relevance) (OJL158 30.04.2004p. SO). Directive 2000/54/EC of the European Parliament and the Council of 18 September2000 on the protection of workers fiom risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC). Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances Official Journal No P 196,16708/1967, p. 0001-0098.
40 Beyond Limits Regulation (EEC) 793/934Z on the evaluation and control of the risks of existing substances Directive 76/769/EEC43 on restricting the marketing and use of certain dangerous substances and preparations and its amendments.
REQUIREMENTS REGULATING CHEMICAL RISKS GENERALLY INTHEEU In the series of Directives beginning with Council Directive 67/548/EEC, and following through Directive 1999/45/EC and Directive 91/155/EEC (as amended) that have been made to harmonise and control the marketing of dangerous substances, two central elements are evident - requirements on hazard identification and assessment. In addition, the requirement on producers to deliver these elements has a universality of application, distinguishes new substances from existing ones and places a major emphasis on responsibilities of producers to communicate information to users. It also utilises, where necessary, measures that restrict the marketing and use of certain dangerous substances and preparations. Responsibilities of Producers to Identify Hazards. The first Community legislation regulating chemical risks was Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (known as the Dangerous Substances Directive or DSD). Its aim was to identify so-called intrinsic hazardous properties of substances that were either already on, or were intended to be, placed on the European market. Although originally designed to cover in particular hazards which might pose a risk when 41
42
43
Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations Official Journal No L 200,30/07/1999, p. 0001-0068. Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances Official Journal No L 0S4,05/04/1993, p. 0001-0075. Council Directive of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (76/769/EEC).
Exposure Limits in the EU 41
handling hazardous substances at the workplace, additional concerns like those for the environment or for consumers were included when brought under the scope of the Directive over the years — in a similar way as they were perceived to be threats to human health and the environment at Community level. Another equally important reasoning for the directive was the elimination of technical barriers to trade, to be achieved by harmonised and legally binding obligations for manufacturers, producers and importers of hazardous chemicals to classify and label them according to the hazards identified under the Directive. The Directive covers fifteen classes of danger for human health and the environment. It has been amended eight times and its annexes have been adapted to technical progress 29 times. Since 1981, it has discriminated between so-called new and existing substances (by which is meant substances either on the European market before or after a specific point in time (1981). Those that were on the market before that date are listed in the so-called EINECS list.44 Substances which are not on this inventory and which are produced in volumes as low as 10 kg per year are subject to a formal hazard assessment procedure*5 before they can be marketed in Europe. Only about 3000 new chemicals underwent this procedure after 1981. Generally, for substances that existed before 1981, there is no such provision. However, a small number of these existing substances have to undergo a risk assessment, but only those which are produced in high volumes (about 140 out of the 100,000 substances listed in EINECS - for further details see below). Communicating information to users. Once identified as dangerous, a substance is listed in Annex I to the Directive, and its hazardous properties have to be communicated to the user via information provided in a very condensed form on the label of the package,46 and in a more detailed form in so-called Safety Data Sheets.4' Under Directive 91/155/EEC as amended48 (the Safety Data Sheet
European Inventory of Existing Commercial Substances. The higher the production volume, the higher the risk assessment requirements In the form of pictograms, symbols and R(isk) and S(afcty) phrases. These data sheets, however, have only to be supplied to such users of a substance or preparation. Directive 2001/58/EC of 27 July 2001 amends Directive 91/155/EEC on the detailed arrangementi for specific information on dangerous preparations in Article 14 of European Parliament and Council Directive 1999/45/EC and relating to dangerous substances in
42 Beyond Limits
Directive) industrial/occupational users49 are entitled to receive additional information via Safety Data Sheets (SDSs). SDSs provide the user with basic information on the physical-chemical and toxicological properties of a substance / preparation as well as information on how to handle, use, transport and dispose of the chemicals in a safe way at enterprise level. In addition, information on first aid measures hi case of fire, accidents or other emergencies has to be provided. Existing substances that are dangerous but not listed in Annex I have to be classified and provisionally labelled by the manufacturer, distributor or importer. The corresponding provisions for mixtures of substances (preparations) were originally laid down in Directive 88/379/EEC, which was replaced by Directive 1999/45/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous preparations (the Dangerous Preparations Directive or DPD). The vast number of preparations50 in existence makes it uneconomical to classify each of them on the basis of laboratory testing. Since this would also mean in most cases animal tests, animal welfare considerations would further render such a task nearly impossible (or politically and ethically highly controversial). Preparations are therefore normally classified with the help of calculation methods, based on the concentration of the various components of the preparation and their intrinsic hazardous properties established under the DSD. Once the appropriate classification has been established, the DPD uses, in general, the same classes of danger and the same labelling requirements as the DSD. However as is clear from the evidence presented in Box 2.1, while classification, labelling and SDSs may be the most important (and often the only) information sources for downstream users of dangerous substances and preparations, they are in fact far from universally either correct or complete.
implementation of Article 27 of Council Directive 67/548/EEC (safety data sheets) (Text with EEA relevance), Official Journal L 212 ,07/08/2001 P. 0024 - 0033. And under certain circumstances also non-industrial/occupational users. Estimates talk about 2,000,000 and more.
Exposure Limits in the EU 43
1 Box 2.1
Compliance with the provisions for classification and labelling and SDSs at EU level Trade unions and practitioners have frequently suggested that SDSs are seldom the useful and accurate sources of information that they are meant to be. Recent survey evidence supports this view. A report of the ECLIPS (European Classification and Labelling Inspections of Preparations, including Safety Data Sheets) project51 undertaken by the Chemical Legislation European Enforcement Network (CLEEN)52 to assess the extent of compliance with the classification and labelling legislation in Member States found that in practice such compliance was quite restricted. The project focused on the DPD'3 and in particular on preparations classified as dangerous for the environment, and / or classified as carcinogenic, mutagenic and / or toxic for reproduction (CMR), and / or containing substances with sensitising properties, and / or containing substances assigned the Risk Phrase R67.S4 In order to keep the results comparable, it was also decided to focus on a limited number of product groups, i.e. paints and varnishes, cleaning agents (e.g. solvent based), detergents, preparations to be used in construction of buildings and photo chemicals. It found that not more than 40 per cent of the preparations currently on the market, and only 30 per cent of the SDSs complied with legal provisions. The labelling of about 60 per cent of the preparations it examined was incorrect and two third of the SDSs were either incorrect or incomplete.
http://www.cleen-eu.nefprojects/Press_release_ECLIPS.pdf/ http://www.umweltbundesamt.at/fileadniin/site/umweltthemen/chemikalien/ECLIPS_Final _Report.pdf. CLEEN is a network of national chemicals inspectorates that coordinates and improves the enforcement of EU chemicals legislation (enforcement is the responsibility of the Member States). Is central task is the exchange of information between national enforcement authorities and it sets, in collaboration with the Member States, priorities for enforcement projects in the EU. Because most of the chemicals on the market are preparations. Vapours may cause drowsiness and dizziness.
44 Beyond Limits
The Universality of the Requirements. A classification under the DSD and the DPD can have a significant impact on the way in which substances are addressed in other Community legislation, hi at least 60 other pieces of Community legislation, reference is made either to the criteria for hazard identification of the Directives themselves or provisions for additional risk reduction measures at Community level are based on the classification of substances listed in Annex I to the DSD. For example, substances and preparations classified as category one or two carcinogens or mutagens are subject to more stringent control and protective measures at the workplace than other (hazardous) substances and preparations. The provisions for the treatment of waste are based on the hazard classification as well as the provisions under the Seveso Directive on the control of major-accident hazards. Finally, the classification of dangerous substances and preparations can have repercussions on the marketing and use of a chemical (see the following section on Directive 76/769/EEC), ranging from the prohibition of the marketing to the general public to a complete ban of a substance. Dealing with Existing Substances. Recognition of the problem of existing substances led the European Council in 1993 to adopt Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances (Existing Substances Regulation or BSR).This Regulation set the framework for the evaluation and control of existing substances, namely those listed on the EINECS list. Because the number of chemicals listed in EINECS (more than 100,000) was far too big to evaluate, a prioritisation took place at European level primarily based on production volumes55 and on the potential risk to man and the environment, resulting in four lists of about 140 substances of high concern.56 S7 5S 59 Substances on priority lists must undergo an
The Regulation was initially concerned with so-called High Production Volume Chemicals (HPVCs), imported or produced in quantities exceeding 1000 tonnes per year, followed by those of lower volumes (between 10 and 1000 tonnes). Commission Regulation (EC) No 1179/94 of 25 May 1994 concerning the first list of priority substances as foreseen under Council Regulation (EEC) No 793/93 Official Journal NO. L 131,26705/1994 P. 0003 - 0004. Commission Regulation (EC) No 2268/95 of 27 September 1995 concerning the second list of priority substances as foreseen under Council Regulation (EEC) No 793/93 Official Journal NO. L 231,28/09/1995 P. 0018 - 0019.
Exposure Limits in the EU 45
in-depth risk assessment,60 following the framework set out in Commission Regulation (EC) 1488/94" and implemented in the detailed TGD on Risk Assessment for New and Existing Substances.62 A Member State (the so-called rapporteur) is responsible for compiling the data, which is discussed at European level aiming at a consensus on conclusion of the risk assessment amongst the various stakeholders. Before the report and the conclusions are finally adopted and published, it is peer-reviewed by a Scientific Committee officially established at European level. Possible results of the risk assessment for existing substances are; (i) (ii)
(iii)
There is need for further information and/or testing. There is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already, There is a need for limiting the risks; risk reduction measures that are already being applied shall be taken into account.
If the risk assessment comes to the conclusion that further risk reduction measures beyond those already in place are necessary, a risk reduction strategy must be developed. Directive 76/769/EEC on the restrictions in marketing and use of dangerous substances is one of the legal frameworks, which could be invoked to manage the risks identified by the risk assessment.
Commission Regulation (EC) No 143/97 of 27 January 1997 concerning the third list of priority substances es foreseen under Council Regulation (EEC) No 793/93 (Text with EEA relevance) Official Journal NO. L 025 ,28/01/1997 P. 0013 - 0014. Commission Regulation (EC) No 2364/2000 of 25 October 2000 concerning the fourth list of priority substances as foreseen under Council Regulation (EEC9 793/93 (Text with EEA relevance) Official Journal NO. L 273,26/10/2000 P. 005-008. Covering the risks to man (covering workers, consumers and man exposed via the environment) and the environment (covering the terrestrial, aquatic and atmospheric ecosystems and accumulation through the food chain). Commission Regulation (EC) No 1488/94 of 28 June 1994 laying down the principles for the assessment of risks to man and the environment of existing substances in accordance with Council Regulation (EEC) No 793/93 (Text with EEA relevance). Official Journal No L 161,29/0671994, p. 0003-0011. http://ecb.jrc.it/php-bin/reframer.php?B=/TGD.
46 Beyond Limits
Restricting the Marketing and Use of Certain Dangerous Substances and Preparations. Directive 76/769/EEC was introduced in 1976 to deal with situations where classification and labelling of chemicals were not sufficient to protect health and the environment and Member States were introducing national restrictions of the marketing and use of chemicals thus creating barriers to trade. The directive sets out detailed rules for restrictions on marketing and use, harmonising the legislation throughout the Community. It creates a framework for bans or restrictions by means of an Annex, where the controlled substances and/or products are listed. These can only be placed on the market subject to the conditions specified. Two different general concepts of restrictions on marketing and use exist, which can be designated as "ban with exemptions" and "controlled use". A ban with exemptions means that marketing and use of the substances are prohibited except for applications that are explicitly allowed. Controlled use means that marketing and use of a substance and the preparations and products containing it are allowed except those that are specifically forbidden. In practice, the concept of "controlled use" is predominant, i.e. a ban limited to e.g. the general public (e.g. benzidine, chlorinated, hydrocarbons) and/or certain applications (e.g. cadmium). The provisions may be related to concentration limits for the substance in a preparation or a product (e.g. emission limit for nickel in jewellery). There are also requirements for specific labelling and other safety measures (e.g. asbestos). A special mechanism for risk reduction in the Directive, that links the directive with Council Directive 67/548/EEC is provided by the 14th amendment in 1994. This allows substances classified as carcinogenic, mutagenic or toxic to reproduction (category 1 and 2) to be banned for consumer use. The provisions in Directive 76/769/EEC do not cover areas where harmonised legislation already exists, e.g. risks to human health from cosmetics and medicinal products. Before any proposal for measures under Directive 76/769/EEC was made, the Commission consults the various stakeholders and is obliged to present an Extended Impact Assessment (ExIA) on the advantages and drawbacks of such a measure, normally undertaken by an independent consultant.
Exposure Exposure Limits in the EU 47
EUROPEAN LEGISLATION WITH A SPECIAL FOCUS ON PROTECTING WORKERS FROM THE RISKS ARISING FROM HAZARDOUS CHEMICALS In addition to measures that are focussed on the responsibilities of producers to identify and assess the hazards of their chemical products discussed above, there are several instruments amongst the array of regulatory provisions at Community level that are of particular significance for worker protection. They include: Directive 98/24/EC
-
Directive 2004/37/EC Directive 2000/54/EC -
protection of workers from the risks related to chemical agents at work protection of workers from the risks related to exposure to carcinogens at work protection of workers from risks related to exposure to biological agents at work.
As we have already noted, these provisions also need to be understood in relation to the requirements regulation health and safety management generally that are found hi Directive 89/39 I/EEC - the so-called Framework Directive. The Framework Directive 89/391/EEC. The directive sets out the principles for further legislation on workers* safety and health. A number of more specific directives (some fourteen all together) have been adopted with reference to this directive. There are no specific rules regarding chemical agents in the directive. However, Article 6 lists the general principles of prevention. They include: — — -
avoiding risks evaluating the risks which cannot be avoided combating the risks at source adapting the work to the individual, especially as regards the design of work places, the choice of work equipment and the choice of working and production methods, - adapting to technical progress — replacing the dangerous by the non-dangerous or the less dangerous
48 Beyond Limits
— developing a coherent overall prevention policy which covers technology, organisation of work, working conditions, social relationships and the influence of factors related to the working environment — giving collective protective measures priority over individual protective measures — giving appropriate instructions to the workers. The Directive not only establishes a framework of general rules for workers' safety and health protection, but also implemented Europe-wide the concept of a modern, comprehensive approach to occupational health and safety, that should be embedded in the overall management of a company. Individual Directives adopted on the basis of Article 16 (1) of the Directive are all based on the same main principles regulating OHS management but establish, in addition, specific and further going provisions, for example, for: — certain vulnerable groups (e.g. pregnant workers) — special working conditions (e.g. working with computers or on fishing vessels) — particular risks (e.g. chemical agents in general or carcinogens and mutagens in particular) — the design of workplaces and the equipment used (e.g. personal protective equipment). With respect to the protection of workers from chemicals, the three Directives, briefly described in the following, are the most important. Directive 98/24/EEC, sets the frame for preventing the risks from chemical agents in general. Its requirements are outlined below followed by those for carcinogens and for biological agents. The Chemical Agents Directive 98/24/EC. The first comprehensive framework for Community legislation on chemicals in the workplace was included in Council Directive 80/1107/EEC, which set out measures for the control of risks due to chemical, physical and biological agents. It was amended in 1988 by the adoption of Directive 88/642/EEC that focused on the mechanism for setting exposure limits for hazardous chemicals. This directive was repealed on 5 May 2001 with
Exposure Limits in the EU 49
the adoption of Directive 98/24/EEC. Besides Directive 80/1107/EEC,63 a number of other earlier Directives (on metallic lead and ionic compounds (82/605/EEC)64 and Directive 88/364/EEC on banning certain specific agents and/or work activities65 which set the scene for protecting workers from chemical and other risks before the Framework Directive came into force, were also repealed at this time. Directive 98/24/EEC lays down minimum requirements for work with hazardous chemical agents. Its provisions apply without prejudice to the more stringent and/or specific requirements of the Carcinogens Directive 2004/3 7/EC as amended. Here again can be found a link to DSD and the DPD, because the scope of the Directives covers any chemical substance and preparation that either is already classified or meets the criteria to be classified as hazardous in the meaning of those Directives. The Chemical Agents Directive also covers chemical substances which, although they do not meet these criteria, may present a risk to safety and health of workers due to their physio-chemical, chemical or toxicological properties. Importantly for our purposes, it provides a framework for setting occupational exposure limit values and biological limit values at European level. It requires: -
that risks arising from chemical agents are identified by employers through risk assessment that exposure should be prevented or at least adequately controlled that exposure should be monitored regularly in those instances where a national OELV is exceeded, the employer is to remedy the situation through preventative and protective measures. Council Directive 80/1107/EEC of 27 November 1980 on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work, Official Journal L 327 , 03/12/1980 P. 0008 - 0013. Council Directive 82/605/EEC of 28 July 1982 on the protection of workers from the risks related to exposure to metallic lead and its ionic compounds at work (first individual Directive within the meaning of Article 8 of Directive 80/1107/EEC), Official Journal L 247 ,23/08/1982 P. 0012 - 0021. Council Directive 88/364/EEC of 9 June 1988 on the protection of workers by the banning of certain specified agents and/or certain work activities (Fourth individual Directive within the meaning of Article 8 of Directive 80/1107/EEC), Official Journal L 179 , 09/07/1988 P. 0044 - 0047.
50 Beyond Limits
hi addition: -
workers have to be informed and trained when handling dangerous substances they are subject to regular health surveillance individual exposure record have to be made and kept up-to date employers have to draw up detailed procedures for dealing with accidents, incidents and emergencies that involve hazardous substances.
The principles set out in the Directive (also found in the Carcinogens Directive see below) are based on substitution, prevention, protection and control. Directive 2004/37/EC (as amended). The Carcinogen Directive. Community action on prevention of exposure to occupational carcinogens began in 1990, when the Council adopted Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens at work (sixth individual Directive within the meaning of Article 16(1) of Directive 89/391EEC). This Directive was amended twice,66 and its scope extended to cover mutagens. On 30 April 2004, a consolidated version of the Carcinogen Directive and its amendment was published in the Official Journal (Directive 2004/3767) The Directive has as its main objective to protect workers' health and safety against risks specifically arising or likely to arise from exposure to carcinogens and mutagens at work which meet the criteria for carcinogens and mutagens (category 1 and 2) under the DSD and the DPD. It lays down minimum requirements concerning carcinogens and mutagens, including limit values.
Council Directive 97/42/EC of 27 June 1997 amending for the first time Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens at work (Sixth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC), Official Journal L 179 , 08/07/1997 P. 0004 - 0006. Council Directive 1999/38/EC of 29 April 1999 amending for the second time Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens at work and extending it to mutagens, Official Journal L 138 , 01/06/1999 P. 0066 - 0069. Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (codified version) (Text with EEA relevance) (OJL 158 30.04.2004p. 50).
Exposure Limits in the EU 51
According to the Directive, it is the duty of the employer to reduce the use of a carcinogen or mutagen by replacing it with a substance, preparation or process less dangerous or not dangerous. If it is not technically possible to carry out such substitution, the employer must ensure that the carcinogen is manufactured and used in a closed system. Where neither of these precautions is possible, the employer must reduce the level of exposure to a carcinogen or mutagen to as low a level as is technically possible. Furthermore, the Directive lists a number of measures to which the employer must adhere when a carcinogen or mutagen is used: -
-
-
-
limitation of the quantities of a carcinogen or mutagen at the place of work keeping as low as possible the number of workers exposed or likely to be exposed design of work processes and engineering control measures so as to avoid or minimise the release of carcinogens or mutagens into the place of work evacuation of carcinogens and mutagens at source, local extraction system or general ventilation, all such methods to be appropriate and compatible with the need to protect public health and the environment use of existing appropriate procedures for the measurement of carcinogens and mutagens, in particular for the early detection of abnormal exposures resulting from an unforeseeable event or an accident application of suitable working procedures and methods collective protection measures and/or, where exposure cannot be avoided by other means, individual protection measures hygiene measures, in particular regular cleaning of floors, walls and other surfaces information for workers demarcation of risk areas and use of adequate warning and safety signs including 'no smoking' signs in areas where workers are exposed or likely to be exposed to carcinogens and mutagens drawing up plans to deal with emergencies likely to result in abnormally high exposure means for safe storage, handling and transportation, in particular by using sealed and clearly and visibly labelled containers.
The employers shall, when requested, make available to the competent authority appropriate information on:
52 Beyond Limits
-
the activities and/or industrial processes carried out, including the reasons for which carcinogens and mutagens are used the quantities of substances or preparations manufactured or used which contain carcinogens or mutagens the number of workers exposed the preventive measures taken the type of protective equipment used the nature and degree of exposure the cases of replacement.
The employer shall also ensure that workers and/or workers' representatives receive sufficient and appropriate training on the basis of all available information concerning the potential risks to health and the precautions to be taken to prevent exposure, etc. In particular, the employer shall inform workers of installations and related containers containing carcinogens or mutagens, ensure that all containers, packages and installations containing carcinogens or mutagens are labelled clearly and legibly and display clearly visible warning and hazard signs. Reinforced health surveillance is foreseen and the practical recommendations for the health surveillance are given in Annex II. Annex III sets limit values on the basis of the available information, including scientific and technical data. At present, Annex III includes only limit values for benzene, vinyl chloride monomer and inhalable hardwood dust. Directive 2000/54/EC (as amended), The Biological Agents Directive. Although it is not of particularly direct relevance to the subject of this account, the third element of the triumvirate of important Community measures with special significance for protecting workers against hazardous chemicals is the Biological Agents Directive. On 17 October 2000, a consolidated version of the Directive and its amendment was published in the Official Journal (2000/54/EC68). It covers the protection of workers from risks related to exposure to biological agents. Biological agents include micro-organisms, cell cultures and human endoparasites that may be able to provoke infection, allergy or toxicity. They are classified into four groups according to their level of risk of infection. It prescribes measures to Directive 2000/54/EC of the European Parliament and the Council of 18 September2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/39 I/EEC).
Exposure Exposure Limits in the EU 53
be taken to avoid risks and dangers resulting from work with biological agents such as equipment, hygiene, handling of agents, reduction of exposure, vaccination of employees etc. An annex contains a classification of organisms.69
OEL SETTING AT THE EUROPEAN LEVEL Since the central focus of this book is on the determination and use of OELs, arrangements at the level of the EU are clearly of particular interest. As noted above, directives such as the Chemical Agents Directive that have a special focus on risk management strategies for hazardous substances in relation to workplaces make provisions for OELs. To appreciate the significance of these provisions it is helpful to first outline the institutional development of approaches to these issues at the level of the EU. Approaches in the past. The objective of setting OELs in the European Union (EU) was introduced into EU legislation by Council Directive 80/1107/EEC, as amended by Directive 88/642/EEC.70 Under this Directive, two types of OELs were defined, binding limit values and indicative limit values (ILVs). Member States were asked to take the ILVs into account when establishing national OELs, but there was no legal obligation to do so. In 1990, at the request of the European Council, the European Commission set up an informal group of scientists, known as the Scientific Expert Group (SEG), to give advice on setting limit values, after having reviewed the different approaches in the Member States. In 1991, the first set of 27 ILVs was proposed by the EC and agreed by Member States on the basis of pre-existing national positions (Directive 91/322/EEC).71
http://agency.osha.eu.int/publications/factsheets/41/en/FACTSN41-EN.PDF. Council Directive 88/642/EEC of 16 December 1988 amending Directive 80/1107/EEC on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work, Official Journal L 356 , 24/12/1988 P. 0074 - 0078. Commission Directive 91/322/EEC of 29 May 1991 on establishing indicative limit values by implementing Council Directive 80/1107/EEC on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work, Official Journal L 177 , 05/07/1991 P. 0022 - 0024.
54 Beyond Limits
In 1995, the status of the SEG was formalised, becoming the SCOEL.72 Today the committee has 21 members from all Member States7* with full scientific expertise needed for this task.74 The SCOEL provides the Commission with recommendations on 'health based' OELs. Based on those recommendations, a second list of ILVs was published in 1996 (Directive 96/94/EC).75 Current approaches and types of OELs. With the introduction of the Chemical Agents Directive in 1998, the concept of OELs changed. In Article 3, the Directive introduced: -
Indicative Occupational Exposure Limit Values (IOELVs) Binding Occupational Exposure Limit Values (BOELVs) Binding Biological Limit Values (BBLVs).
IOELVs are supposed to be health based, whereas BOELVs take technical and / or economical feasibility considerations into account. With respect to the IOELVs, Member States had no longer an option whether or not to take them into account. They now have to set a national exposure limit value to implement the IOELV. They can however — under certain conditions - exceed at national level the value of the OEL set at Community level.
95/320/EC: Commission Decision of 12 July 1995 setting up a Scientific Committee for Occupational Ejqsosure Limits to Chemical Agents , Official Journal L 188 ,09/08/1995 p. 0014-0015. The Commission appoints these members after consulting the respective Member States, having regard to the need to cover all relevant aspects of the committee's work. The term of office for SCOEL members is three years and their names are published in the Official Journal of the European Union. Meetings of the committee normally take place four times a year and individuals with particular expertise in the subject under study are sometimes invited to participate. The SCOEL comprises experts in chemistry, toxicology, epidemiology, occupational medicine and industrial hygiene and has general competence in setting OELs. Commission Directive 96/94/EC of 18 December 1996 establishing a second list of indicative limit values in implementation of Council Directive 80/1107/EEC on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work (Text with EEA relevance), Official Journal L 338 , 28/12/1996 P. 0086-0088.
Exposure Limits in the EU 55
For any chemical agent for which a binding value is set at Community level, Member States have to set a corresponding national binding value. The national binding limit value can only be stricter, but cannot exceed the Community limit value. A first list of IOELVs was established in Commission Directive 2000/39/EC of 8 June 2000.76 Procedures and bodies involved. The SCOEL starts its work by evaluating criteria documents from different sources. The Commission, through publication in the Official Journal, announces the identified base document with the request for further data, especially that which is unpublished, to be provided to the Commission, to guarantee the completeness of the data for the chemical agent concerned. The SCOEL evaluates the scientific dossier and the supplementary data for the identification of the critical health effects and then proposes a recommendation for a health-based limit value in a summary document, which in addition to the recommendation for an OEL, also contains further information on the basic data, a description of the critical effect, the extrapolation techniques used, and any data on possible risks to human health. The technical feasibility of monitoring exposure is also noted. Furthermore the SCOEL identifies important gaps in the data and the need for more research. Once the Committee agrees the summary document the Commission makes it public to interested parties with the request for health based scientific comments and eventually further data. After a period of about six months allowed for comments, the SCOEL rediscusses the document in the light of the comments received and adopts the final version, which is then published by the Commission. When the Commission services have received recommendations from the SCOEL they are in a position to develop legal proposals for OELs. At this stage and according to the type of OEL, the Commission services will seek relevant technical and socio-economic data. If any of the interested parties is aware that there are such data which can be shown to be pertinent to the development of a
Commission Directive 2000/39/EC of 8 June 2000 establishing a first list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work (Text with EEA relevance), Official Journal L 142 , 16/06/2000 P. 0047 - 0050.
56 Beyond Limits
Commission's proposal then these should be made known to the Commission services. The Commission's proposal for a legislative text is submitted to the Advisory Committee for Safety, Hygiene, and Health at Work, (ACSHH), a tripartite committee consisting of representatives from governments, employers' organisations and trade unions. At this stage all the interested parties have a further opportunity, through the ACSHH structure, to contribute to the opinion adopted by the Committee. The opinion delivered by the ACSHH is available through its minutes and is also published in the ACSHH's annual report. Once these consultations have been completed the Commission services will finalise their preparation of a proposal to be agreed by the Commission. According to the type of OEL (binding or not binding) and the legal procedure selected, further consultation on the Commission's proposal, within the appropriate European Union institutions, will take place, before the final adoption and publication in the Official Journal of an OEL.77
EFFECTIVENESS OF THE EXISTING LEGISLATION AND THE FUTURE APPROACH AT COMMUNITY LEVEL Despite the quantity and detail of existing provisions at Community level, effective risk management of hazardous substances and preparations at Community and national level is far from guaranteed. Indeed, there is widespread recognition that its regulatory instruments have turned out to be fairly inefficient in particular because the processes they invoke are operationally time consuming and because they set different risk assessment obligations for so-called new and existing substances they have resulted in substantial data gaps for the majority of substances78 marketed in Europe.
OELs are measured or calculated for a reference period of eight-hour time weighted average (TWA). For a number of substances, short-term exposure limit values (STEL) are also given, representing a limit value above which exposure should not occur and which is related to a 15-minute period, unless otherwise specified. They are expressed either in mg/m3 of air at 20 °C and 101,3 KPa or in ppm. In addition, a skin notation can be assigned to the OEL, indicating the possibility of significant uptake through the skin. Most of the estimates speak about 99 per cent.
Exposure Limits in the EU 57
A Commission report on the operation of the main instruments was published in 1998,79 leading to the conclusion that the existing legal framework was not adequate (CEC 1998). As a consequence, the Commission developed its White Paper on a Strategy for a Future Chemicals Policy, which was adopted in 2001. It argued:80 -
There is a lack of knowledge about the dangers of many chemicals on the EU market. This makes it difficult to assess their risks properly and to make informed decisions about controlling those risks.
-
The current process of risk assessment is much too slow. Only a handful of chemical substances are assessed at EU level each year.
-
Resources are concentrated too much on the assessment of "new substances" which make up less than 1 per cent of the total volume of substances on the market and not enough on "existing substances". This has the effect of stifling innovation in new chemical products.
In May 2003, after additional impact studies and various discussions at Council level and with different stakeholders, the Commission published a draft proposal that was then subject to consultation resulting in more than 6,000 Stakeholder Representations including those from Member State Governments, Competent Authorities, the Chemicals Industry and other interested parties. Following the consultation, the Commission adopted a proposal for the 'Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals' otherwise known as REACH. It modified several of its initial requirements in what several commentators have seen as concessions to a powerful industrial lobby (Epstein 2005). The legislative proposal was put before the European Parliament and the Council where it remains subject to intensive discussions.81 http://eviropB.eu.int/coniin/eiivironni8nt/cheinicals/pd&report-4-instiuiBents_en.pdfi'. Commission Working Document: Report on the operation of Dir, 67/548, Dir. 88/379, Reg 793/93 and Dir. 76/769. http://europB.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEX numdoc&lg=EN&aumdoo=52001DC0088&model=guichett. The Commission proposal is subject to the co-decision procedure.
58 5 8 Beyond BeyondLimits him its
The main element of the new Regulation as proposed by the Commission can be summarised as follows:82 REACH will replace the main pieces of European chemical legislation by an integrated system. It will eliminate the current distinction between 'existing' and 'new* chemicals and their respective testing requirements.83 In outline it consists of several interlinked requirements on chemical producers concerning the registration, evaluation and authorisation of their chemical products. They are: (1) Registration - Registration requires all chemicals manufactured in or imported into the EU in a volume of 1 tonne or more per year to be registered with the competent authority within a new European Chemicals Agency (ECA). The ECA will manage a central, EU-wide database. - Companies will have to submit basic information including a brief description of the uses of the substance and any uses that the manufacturer advises against84, as well as a technical dossier of test data and future testing proposals. - Data requirements vary according to the production volume and suspected toxicity of the substance. - Registration will be undertaken in several stages, with deadlines varying with production volumes: - Substances supplied in excess of 1,000 tonnes a year and some substances of so-called 'high concern' (e.g. CMRs,85 PBTs,16 or vPvBs87) will be registered within 3 years of the law coming into force - those in excess of 100 tonnes within 6 years - those in excess of 1 tonne and 10 tonnes within 11 years. - For chemicals that raise no particular concerns or annual production of which usually remains below a ceiling of 100 tonnes, registration will be 82 83
http://europa.eu.int/comin/entBrprise/reach/. Certain chemicals are exempted from the proposals; these include polymers, intermediates in chemical processes that never leave the factory, pharmaeeuticals a n d foods. If a company wishes to employ a chemical for an unregistered use the registration dossier must be updated to reflect this. Substances being carcinogenic, mutagenic or toxic to reproduction. Substances being persistent, bioaccumulative and toxic. Substances being very persistent and very bioaccumulative.
Exposure Limits in the EU 59
sufficient. All substances produced or marketed in greater volumes, or which are more sensitive, will be subject to evaluation. (2) Evaluation - National authorities on the basis of the registration data will undertake evaluation. Two types of evaluation are proposed: - Dossier evaluation - all registrations that propose further animal tests will be evaluated to ensure that such tests are strictly necessary. The evaluation process checks if test data for the substance in question are already available, and whether alternative tests could be employed to prevent unnecessary animal testing. - Substance evaluation - carried out if a competent authority suspects that a substance poses a risk to human health or the environment (for example because of its structural similarity to a known dangerous substance). This involves examining the dossiers of all registrations for a substance to clarify the risks and may result in the authority requesting further information from those registering the substance. (3) Authorisation - Substances identified through registration and/or evaluation as being of high concern (CMRs, PBTs, vPvBs) cannot be used or placed on the market without authorisation. Authorisation will be granted to the producer / importer of a substance only (one for each use and user) if they can demonstrated that they can control, in an appropriate way, the risks posed by the chemical or that the socio-economic benefits of the substance outweigh the risks. This type of decision may take into account whether industry is actively researching to find an alternative substitute. Authorisations granted for socio-economic reasons will be time-limited and reviewed on a case-by-case basis. The use of other substances that pose unacceptable risks, but are not classified as of high concern, could be restricted if requested by a Member State. Restriction may ban use in certain products, by consumers, or even any use at all.
60 Beyond Limits
REACH AND WORKER PROTECTION In summary, it is intended that the measures in REACH will increase the effectiveness of existing provisions to protect workers exposed to dangerous substances and combat risks of ill-health caused by work-related exposure to chemicals by: -
-
providing information that is currently not available on the properties of chemical substances and ways of minimising the risks associated with using them improving the communication of such information throughout production and supply chains promoting substitution of the most harmful chemicals with less hazardous ones by means of its authorisation and restriction provisions.
The extent to which this will actually occur however depends on several issues for which the prognosis is at present unclear. Partly because of this, REACH has generated considerable debate. For the social and economic interests involved this debate has been polarised around issues of costs versus benefits, with the former being emphasised by industry and the benefits for human health and the environment championed by social interest groups such as environmental NGOs and most of the trade unions.88 The assumptions made by or on behalf of all the interest groups involved regarding such costs and benefits, coupled with the additional problem that it is as yet unclear what form the final implementation of the regulation will take, or how it will work in practice, make it very difficult to predict outcomes either with regard to workers" protection in general or the particular future for OELs in this process. Nevertheless some things seem clear. First, while the requirements in REACH will undoubtedly contribute to increasing knowledge and information concerning the hazardous properties and safe use of far more chemicals in use in Europe than is currently the case, the extent to which the communication of such information and its usefulness in practice will be enhanced by the Regulation is less certain. The policy rhetoric behind REACH places considerable emphasis on not only how the measures will involve greater requirements on chemical producers to exercise responsible stewardship of their products, but also how such duties will
See for example Musu (2004).
Exposure Limits in the EU 61
extend though the supply chain with the result that formulators and users will also be bound to engage in a far more active way in ensuring the safety of chemical substances than is currently the case. However, such reasoning seems to be based on a particularly optimistic way of looking at how supply chains actually operate in relation to health and safety of workers as well as on a fairly limited assessment of what prevents users from either understanding or using the information on the safe use of chemicals that is currently available. These are issues to which we will return in our discussion in the final chapter of this book, but it is sufficient to note that the existence of business networks for production, supply and demand do not automatically lend themselves to a role in enhancing health and safety - indeed in some cases they owe their existence to attempts by business organisations to off-load responsibilities for health and safety.89 Furthermore, current research findings on risk communication in relation to chemical hazards suggest that user's understanding and use of safety information is the result of a more complex set of factors than merely the failure to supply the information in the first place.90 This is of course especially important in relation to the role of OELs in risk management strategies at the workplace level. Again, we shall return to this discussion in the concluding chapter of this book. A final point is that (at least as far as the current proposal is concerned) REACH will probably have little immediate effect on the current situation at the work places with regards to OELs, because test requirements on suppliers in REACH are based on the annual production or importation volume of a substance and for substances between 1 and 10 tonnes they will not - for the reasons outlined in Chapter 1 - allow the development of OELs for substances which don't already have one. This might change in the long term, after all substances have been registered and the data evaluated.
For example business organisations frequently out-source both services and goods to wider supply networks in attempts to reduce the costs of these functions to their core organisation. See for example, the findings of the recent ECLIPS (2004) study in the light of British based research findings such as those of Briggs (2000); Kigston-Howlett (2001); Wiseman and Gilbert (2002)and Middlesex University Business School,(2004) that will be discussed further in ChapterlO.
62 Beyond Limits
CONCLUSION It should be evident from the preceding pages that there has been a substantial system for regulating risk management of hazardous chemicals in place at the level of the EU for some considerable time. It emanates from two overlapping sources, one that deals with trade and the other for the protection of workers. The system is based upon sound prevention principles, including those of hazard identification, risk assessment and communication as well as principles of safe practice that emphasise substitution and control at source and is vested with sufficient authority to deem certain substances too dangerous to be marketed unless under strict and specified conditions. The outline presented here demonstrates how regulating the risks from occupational exposures to hazardous chemicals forms a special part of this system overall and needs to be understood in this context, as well with reference to other measures regulating health and safety management such as those in place in all member states as a result of their transposition of the Framework Directive 89/391. Structures and procedures for setting exposure limits at EU level have developed as part of this subsystem for regulating chemical risks in relation to the workplace. However, the current view of the existing system is that its burgeoning regulatory requirements are failing in the degree to which they could be deemed to be effectively operational and contributing significantly and cost effectively to minimising the risks to health and the environment posed by hazardous substances at work, in consumer products and elsewhere in the environment. As a consequence, a new regulatory strategy is under discussion and likely to become effective in whole or in part over the coming decade. As we have indicated, it is unlikely that the immediate effects of the new strategy on the position and role of OELs will be particularly significant. However the thinking behind it is important and several aspects of the new proposals and the assumptions on which they are based could be particularly significant in relation to managing risks associated with hazardous substances in the medium to longer term. This is especially so in relation to the position of users of chemicals in small and medium sized enterprises where, as we shall see in subsequent chapters, the failures of existing provisions in relation to the role of OELs have been felt most acutely. We will return to this discussion in our concluding chapter, which follows the detailed exposition of the extent of the problem presented in the country chapters later in the book. Before doing so it is necessary to consider the position of OELs
Exposure Limits in the EU 63
in the legislative systems of the EU 15 countries, the extent to which such positions are comparable and the effects that approaches to OELs at the level of the EU have had on them. It is to these issues that we turn in the following chapter.
This Page is Intentionally Left Blank
65
SYSTEMS FOR SETTING AND USING OCCUPATIONAL EXPOSURE LIMITS IN EU15 COUNTRIES
INTRODUCTION
This chapter continues our analysis of the nature and role of requirements on setting and using OELs within regulatory systems that we started in Chapter 2 in relation to European Community institutions. In the present chapter however we are concerned with the position at the level of the member states, and specifically with that in the EU 15 member states. The primary intention here is to document comparable and distinguishing features of the various national level institutional and legislative frameworks in which exposure limits are developed and used. To these ends a considerable amount of detailed information on different national structures and systems was gathered, both in the original research project on which the book is based (Walters et al 2003) as well as more recently in updating that material and adding to it new elements. The main aspects of the various systems for setting and using OELs have of course not changed within the last two years. However, there have been changes to the lists of OELs in some countries as well as to many of the Internet links identified in the previous published report (Walters et al 2003). Also significant for accurate documentation of national systems is the tendency to reshuffle responsibilities within governments after an election, resulting in changes in the ministries responsible for the establishment of occupational health and safety legislation in general and for publishing/issuing the OELs in particular. We have therefore attempted to reflect these changes in the current chapter. We believe it to be a fair snapshot, but it is important to caution
66 Beyond Limits
that the details of the administrative and regulatory systems described here are subject to continuing change. In order to avoid cluttering the text with too much detail, to maintain clarity in terms of highlighting major points of comparison and difference, and for ease of reference to the material itself, much of this information has been presented in tabular form. In addition, further relevant information in tabulated in Annexes I to IV that can be found at the end of the book." The tables presented in the following pages and in the related annexes therefore outline current information, that while not essential for the understanding of the principles behind the development and operation of various systems they describe, provides the necessary tools to dig deeper into the subject, if this is required. The chapter begins with an overview of the institutional framework regulating occupational health and safety in each of the EU 15 countries. This is followed by an outline of the basic legislative frameworks governing occupational health and safety generally, and chemical substances specifically, in each country. This information is supported by further material on responsible institutions and on the transposition of EU provisions into national laws in the EU 15 countries in Annexes I, n and III. The chapter continues with the tabulation of comparative aspects of the features of systems for setting limit values, including the main types of limit values set, their origins, the number in each country, notations used, the frequency with which they may be updated and other relevant information for all the EU 15 countries. This is followed by a tabulated comparison of the procedures for setting exposure limits in each country, including the involvement of social partners and other bodies in these processes. We outline the systems for enforcement and surveillance of compliance with OELs in each country. Finally we conclude the chapter by identifying and briefly discussing some of the main issues concerning the role of OELs in national systems. These issues will be pursued in greater depth in subsequent chapters on the six countries that are the subject of our detailed study.
Additional details can also be found in Walters et al (2003), the published research report of the original study on which this book is based.
Occupational Exposure Limits in in the EU 67 67 Occupational
REGULATORY SYSTEMS AND RESPONSIBLE BODIES Table 3.1 gives an overview on the institutional framework for occupational health and safety in each country. It lists the: -
responsible ministry and its sub-department(s) scientific and / or other bodies and institutions involved in developing OELs at national level authorities responsible for surveillance and enforcement.
Names are only provided in English where translation was provided in one of the official or semi-official documents and websites used for compiling the data. In all other cases, the original name has been kept. Relevant web-site addresses where they exist for the ministries and the other bodies and institutions mentioned below are listed in Annex I (Websites of Ministries and other bodies involved in H&S).
68 Beyond Limits ON
00
Table 3.1:
National institutions with responsibilities for developing occupational exposure limits for surveillance.
Country
Ministry
Sub-Department(s)
Austria
Federal Ministry of Economics and Labour Le Service public federal Emploi, Travail et Concertation sociale (SPF) Ministry of Employment
Department III - Labour Law and Labour Inspectorates Direction generate Controle du bien-etre au travail Division du controle des risques chimiques
Ministry of Social Affairs and Health
Occupational Safety and Health Department
Belgium
Denmark
Finland
Working Environment Authority
Scientific and other bodies / institutions involved Arbeitnehmerschutzbeirat
Surveillance Authority Central Labour Inspectorate Inspection du Travail et des mines
National Institute of Occupational Health; Working Environment Council and its Committee on Limit Values Advisory Committee for Occupational Health and Safety on Chemicals; Finnish Institute of Occupational Health
Working Environment Authority
Occupational Safety and Health Inspectorates
Ministry
France
Ministere de I 'Emploi, Secteur emploi / travail du Travail et de la Direction des relations du travail Cohesion sociale
Germany
Federal Ministry of Economics and Labour
Greece
Ireland
Ministry of Employment and Social Protection Ministry of Health and Welfare Minister for
Sub-Department(s)
Federal Institute for Occupational Safety and Health (Bundesanstalt fiir Arbeitsschutz und Arbeitsmedizin)
General Directorate of Working Conditions and Health; Centre of Occupational Health and Safety Health and Safety Authority
Scientific and other bodies / institutions involved Conseil superieur de la prevention des risques professionnel; Institut National de Recherche et Securite Caisse nationale de I'Assurance Maladie des travailleurs salaries Regional Offices for Industrial Safety (Landesamter fur Arbeitsschutz); Institutions for statutory accident insurance and prevention for trade and industry (Berufsgenossenschaften); Committee for Hazardous Substances (Ausschuss fur Gefahrstoffe)
Surveillance Authority L 'inspection du travail
Trade Supervisory Offices (Gewerbeaufsichtsdmter) Technical Inspection Services (Technische Aufsichtsdienste)
National Council for Health and Soma Epitheorisis Safety at Work; National Health Ergasiss (Joint State and Safety Institute Technical Inspectors)
Advisory Committee on
Health and Safety
Occupational Exposure Limits in the EU
Country
I I
3
69
70 Beyond Limits -J
o
CO
Country
Italy
Ministry
Sub-Department(s)
Enterprise, Trade and Employment Ministero della Sanita Ministere del Lavoro e delle Politiche Sociali
Luxembourg Ministere du Travail etdul'Emploi Portugal Ministeria do Trabalho e da Solidartedade
Scientific and other bodies / institutions involved Dangerous Substances
Surveillance Authority Authority's inspectorate
Istituto Superioreper la Ispettorato del Lavoro Prevenzione e la Sicurezza del Lavoro; Istituto Superiore di Sanita; Commissione consultiva tossicologica nazionale; Instituto Nazionale per L 'Assicurazione contra gli Infortuni sul Lavoro Istituto Italiano di Medicina Sociale; Commissions consultiva permanente per la prevenzione degli infortuni e I'igiene del lavoro
Direccao-General das Condigiones de Trabalho — DGCT
Instituto para a Seguranca, Higiene e Saude no Trabalho
L'Inspection du Travail et des Mines Inspecgao Geral do Trabalho-IGT
I
Ministry
Spain
Ministerio de Trabajo Commission Nacional de y Asuntos Societies Seguridad y Salud en el Trabajo (Ministry for Labour and Social Affairs) Ministry of Industry, Swedish Work Environment Employment and Authority Communication Ministerie van Sociale Directoraat-Generaal Zaken en Arbeidsverhoudingen en Werkgelegenheid Internationale Betrekkingen
Sweden
The Netherlands
United Kingdom
Department of Work and Pensions
Sub-Depart nient(s)
Health and Safety Commission/Health and Safety Executive
Scientific and other bodies / institutions involved Instituto Nacional de Seguridad e Higiene en el Trabajo
Surveillance Authority Inspection de Trabajo
Swedish National Institute for Work Environment Working Life; Swedish Criteria Inspection Department Group Health Council of the Labour Inspectorate Netherlands Expert Committee on Occupational Standards DECOS; the Social and Economic Council Sub-Committee on MAC values of the Social and Economic Council Advisory Committee on Toxic Substances (ACTS)
Health and Safety Executive
Occupational Exposure Limits in the EU
Country
§•
•3
I
71
72 Beyond Limits
IMPLEMENTING EU REQUIREMENTS IN EU15 MEMBER STATES All EU 15 Member States claim to have transposed relevant European legislation dealing with occupational health and safety in general and with hazardous chemicals in particular into national legislation. However, some indication of the extent to which this is a reality is provided by the annual reports of the Commission monitoring the application of Community law.*2 According to the most recent of these reports for example, a decision has been taken to refer France and Italy to the European Court of Justice because they have not yet notified measures transposing Directives 98/24/EC and 2000/39/EC respectively. Moreover, following the judgment given by the Court of Justice against Austria for failure to notify Ml measures transposing Directives 95/30, 97/59 and 97/65 (risks of exposure to biological agents at work), Article 228 proceedings are in motion as regards the first two directives. Several infringement proceedings have also been commenced or continued regarding problems of incorrect transposal of the Framework Directive 89/39 I/EEC and its specific directives. Reasoned opinions were sent to Austria, France and Spain regarding the transposition of this Directive. Proceedings are also still in motion against Ireland, Sweden and the United Kingdom and the cases against the Netherlands and Luxembourg have reached the Court of Justice. On 7 February 2002 judgment was given against Germany for incorrect transposal of the obligation imposed by the directive for a health and safety risk evaluation to be available in documentary form at all times. When European Directives dealing with the protection of workers from risks arising from hazardous chemicals have been transposed into national legislation, in most cases they have been integrated into existing national chemicals legislation. The Framework Directive 89/3 9 I/EEC, however, which was somewhat of a milestone in health and safety legislation at European level, provided for so many obligations for all stakeholders that in many countries a separate law was needed to transpose it into national legislation.93
See for example, the 20th Annual report on monitoring the application of Community law (2002), Brussels 21.11.2003, COM(2003) 669 final http://europa.eu.int/eurlex/en/com/rpt/2003/ actO669en03/l.pdf, For details see Walters et al 2002 and also Vogel 1993 and 1998.
Occupational Exposure Limits in the EU 73
In addition, in all countries there is legislation (either as an individual enactment or as part of another piece of legislation) that transposes EU directives on: -
carcinogenic and rnutagenic substances in general and on asbestos in particular biological agents lead and vinyl chloride monomers banning certain substances / work procedures94 safety data sheets95 occupational exposure limit values.
In Annex If an overview on the transposition in each country of the main pieces of European legislation dealing with hazardous chemicals and workers protection is provided. In Annex HI, are found the names and the source of the basic legislation, transposing the Framework Directive (89/39 I/EEC), the Chemical Agents Directive (98/24/EC), and the Carcinogen Directive (2004/37/EC) into national law in each country. A Unk to a web page where the most recent OEL list can be found is also provided (if existent).
OCCUPATIONAL EXPOSURE LIMIT VALUES IN THE EU IS COUNTRIES Table 3.2 compares the various Emit value lists from each country in terms of: 94
95
acronyms and names/types (health based/economically-technically based) of OEL listed source of OELs (own system or based mainly on other systems like the US, the German or Nordic systems) information given on forms of notations etc. number of substances listed
Transposition o f Directive 88/364/EEC banning o f certain agents and activities (01.01.90) repealed by 98/24. The Directive on Safety data Sheets as amended has a different legal basis than the other Directives on health and safety. Nevertheless, this Directive is an important tool for providing information on hazardous chemicals at the workplace, and it is therefore listed here.
74 Beyond Limits -
other information provided regularity of updates (yes or no/last update).
In general, all OELs are established for single substances96 and fulfil the following requirements. Their underlying basic assumptions are that they are established for healthy people of employable age. Definitions for OELs include those for: -
Health-based OELs. "Maximum allowable concentration in the workplace / in the breathing zone of a worker of a working material in the form of gas, vapour, or air-suspended matter which, according to the present state of knowledge, generally does not impair the health of the workers even through repeated and prolonged exposure."
-
Technically/economically based OELs. "Concentration of a dangerous working material in the form of gas, vapour, or air-suspended matter in the air at the workplace, which can be achieved according to the state of the art in technology/the best available technology.
-
Biological limit values. Maximum value for the content of the substance or of one of its metabolites in biological media (i.e. blood, urine).
There are three different kinds of units in which the OEL concentrations are presented: -
-
ppm (number of cubic centimetres of pollutant per cubic metre of air — independent from temperature and air pressure), for gases and vapours (volatile substances) mg/m3 (milligrams of pollutant per cubic metre of air) at 20°C and 101.3 hPa for non-volatile substances and airborne particles Fibres/m3 for substances that occur as airborne fibres (e.g. asbestos).
There are several reference periods for which OELs may be established (if they are established) that are commonly used. They include: -
TWA: time-weighted average, for a shift average of normally 8 hours daily, in an average weekly working-time of 40 hours" Provisions on how to deal with mixtures are described in the lists.
Occupational Exposure Limits in the EU -
-
75
STEL: Short-term exposure limit values measured over a duration of maximum 15 minutes, normally only allowed for a maximum of one hour within the 8hour period C; Ceiling values98 - STELs that must not be exceeded at any time.
Most lists and/or the relevant legislation contain: -
notations for skin provisions on how to deal with mixtures.
Fca: a 4-shift-premise, the basis is 42 hours per week on average for four consecutive weeks. Normally established for substances which are so fest-acting that the level of exposure to them can never be permitted to exceed the limit value.
Country
notations etc
other information
"S" (and sub-groups) for sensitising
Provisions on how to
- ACGIH / German MAK Commission. Currently own system in place
substances "H" for substances, which can penetrate the
calculate the OELs for mixtures
- MAK list: ~ 700 main entries102 plus ~ 540 entries for synonyms of the main entries; = 210 of these
skin easily
Provisions for specific (groups of) substances
Type, origin, number and frequency of updating OELs - MAK;99 TRK100
Austria
101
entries are referring to either Annex II (TRK list) or Annex III (carcinogens) or both Annexes - Yes (2003) Belgium
99
100 101 102
103 104 105
(carcinogens, volatile substances, wood dust etc.)
- VLEP;103 VLB104
A - for substances which release a gas
Provisions on how to
- Principally based on the US ACGIH list of 1993105 and the EU lists of OELs - = 670 entries (no entries with synonyms etc); = 100 entries for carcinogens & mutagens
which is not toxic but reduces the amount of oxygen in the air C - recognised carcinogens or mutagens D - risk of absorption of the substance via
calculate the OELs for mixtures
Maximale Arbeitsplatzkonzentration - Maximum Workplace Concentrations. Technische Richtkonzentrationen -Technical Guidance Concentrations. American Conference of Governmental Industrial Hygienists. Individual substances or group entries either specifying the individual substances within the group entry or like xyz and its salts or xyz compounds or xyz and its compounds. Valeurs limites d'expositionprofesionnelles — professional exposure limit values. Valeurs limites biologiques - biological limit values. Information given by the Belgian member of the SCOEL and the representative of the Belgian Government in the AHG Limit Values.
76 Beyond Limits
Table 3.2 Some common features of OEL terminology in EU 15 country lists
50 3"1 and mor UD, TEI, Seo.Education E<S0 UDorTEI E>650 1" UD, 2nd UD or TEI, 3 ri and more, UD, TEI ,SE 50<E://www.iims,it/.
272 Beyond Limits National Health Service and epidemiological researchers. Reports on single chemicals or groups are distributed on request and free of charge.373 The National Institute of Insurance against Accidents at Work (Institute? Nazionale per L 'Assicurazione contro gli Infortuni sul Lavoro - INAIL). Operates under the authority of the Ministry of Labour, managing the mandatory insurance funds against occupational accidents and pathologies. The INAIL has regional and local offices all over the country. The Italian Institute of Social Medicine (Istituto Italiano di Medicina Sociale - IIMS) An advisory body, under the Ministry of Labour, devoted to study and research regarding social diseases and prevention tools. The Permanent Advisory Committee for Accidents Prevention and Occupational Hygiene (Commissione consultiva p&manente per la prevenzione degli infortuni e Vigiene del lavoro). This committee, chaired by the Minister of Labour, monitors the application of legislation, as well as its updating, and is composed of a great number of members regarding all aspects of OHS. The most represented bodies are: the Ministry of Labour, Ministry of Health, ISPESL, Regions and Autonomous Provinces, Trade Unions, Employers' Organisations. In addition, the following institutions are represented by one member each: the Ministry of Industry and Trade, Ministry of the Interior, Ministry of Defence, Ministry of Transport, Ministry of Agriculture, Ministry of Environment, Office of the Prime Minister, INAIL, EMS, National Institute of Health (ISS), National Fire Brigade, National Research Council (CNR), National Body of Standardisation (UNI), Italian Electrotechnical Committee (CEI), National Environment Protection Agency (ANPA). Implementing the EU Chemical Agents Directive and the IOELVDirective. In order to implement the transposition of the EU Chemical Agents Directive and the IOELV Directive made under it, several new committees and working groups have been set up. One was composed of nominees of the various ministries and is responsible for implementation of indicative values in the IOELV Directive. The Ministries of Labour and Industry defined the need for a Working Group with membership of about 25 persons representing wide-ranging interests in order to assist with guidance on the http://www.occuphealth,fi/e/eu/haste/i01 Lhtm, Although this committee still exists formally, according to sources in Italy it has not met for at least four years. Deereta Legislative n. 626 del 19/09/1994 Coordinate con Decreto Legislative n. 242 del 19 mono 1996,
Italy
273
definition of risk. At the same time, following a request from the Ministry of Industry and associations representing the interests of small enterprises, ISPESL created a national working group organised in seven sub-groups to deal with the production of guidelines on the transposition of the Chemical Agents Directive. It is particularly charged with dealing with the needs of small enterprises in this respect. In addition there is a group of experts designated by the Regions that has also produced its expert, nonbinding guidelines on the implementation of the Directive.375 It seems likely that these guidelines will be approved by ISPESL. A Ministerial Commission is being created by the combined efforts of the Ministries of Labour and Health. Legal status of Occupational Exposure Limits.376 D.Lgs 25/02 implements the Chemical Agents Directive 98/24 EC. It is intended to be integrated with D.Lgs 626/94 which provides for the over-riding approach to regulating systematic health and safety management in Italy (in line with the requirements of the EU Framework Directive 89/391), of which managing chemical risks is seen as one part. Only the OELs from the European Union are legally binding nation-wide. Currently this means that there are only five binding OELs (for lead, wood-dust, vinyl chloride, asbestos and benzene) and no indicative ones. TLVs agreed between social partners are only valid for the sector for which the collective agreement has been adopted. If limit values, established either via the EU or via collective agreements, are higher than those technically achievable, then such transposed/agreed values are considered to be against the law. With respect to the European Union this is generally not a problem, because all OELs based on health and safety Directives are anyway minimum standards and Member States are free to establish better values. The same seems to be the case for sectoral national agreements. If they are higher than those that can be technically achieved, they are legally void. To appreciate the significance of the thinking behind this, both types of values have to be seen in conjunction with the principle of reducing exposure to As Low As is Technically Achievable (ALATA ) that is the theoretical basis of Italian regulatory strategies on hazardous substances. According to this principle, the employer is obliged and the worker entitled, to avoid exposure to chemical agents that can have an adverse effect on health. The principle is regarded as
375
376
Presented at a Conference i n Modena in 2002 (Coodinamenta Tecnico per la Sicurezza net Luoghi di lavoro delle Regioni e deile Provincie autonomie (2002)). This again is information given b y ISPESL, a n epidemiologist from Turin and various trade
274 Beyond Limits an expression of the fundamental constitutional workers' right to health and safety discussed previously. Discussion at national level on how to deal with the obligations arising from transposing the Chemical Agents Directive and the lists of Indicative and Binding Occupational Exposure limit based on this Directive, reflect in particular the concern that binding limit values might threaten the highly valued ALATA principle. For trade unions especially, there is a worry that because Italy's capacity to influence developments at European level is not as great as that of countries with internationally recognised procedures for setting OELs,377 the Italian ALATA principles they cherish may go unrecognised at EU level. According to the trade unions (CGIL/CISL/UIL)"8 therefore, maximum effort should be made to establish at national and European level healthbased OELs in a more systematic way. They argue these health-based values should be developed by independent scientists and should extend to more sensitive groups of workers. They believe their OEL approach therefore covers far more workers than the one generally used by national OEL Committees in other European countries. The unions would not regard most of the so-called health-based values established in other countries health-based at all, and consider that their own approach (ALATA) guarantees much lower exposure levels at the work places. Despite this theoretical position, in practice the trade unions recognise that the process of establishing health-based Europe-wide recognised OELs is very time consuming. They therefore accept (in order to speed up the process for getting OELs at all) for the time being what they call 'technical OELs', or 'occupational exposure action levels'. What is meant by compliance? Based on the transposed European Framework Directive and the obligation arising from the Directive 80/1107/EEC, employers are obliged to assess the risk to workers arising from the exposure to dangerous substances at work. The employer 'is obliged to adopt within the company those measures which according to the particular features of the job, experience and technology - are necessary to ensure the physical and emotional integrity of workers' (Art. 2087 of the Civil Code). Therefore, once the risk has been identified, the only theoretical limitation for the employer when adopting preventive and protective measures (aimed at eliminating or reducing the risk) is technical feasibility. However, the Directive 98/24/EC distinguishes what is required in terms of risk assessment between 'slight' Such as the UK, the Netherlands, Sweden and Germany. This is based on information in 'I Valorie-limite per I "esposizione professionals a Sostanze conceroge', CIGL, 2002 Fiere, Modem.
Italy
275
risk and other risk categories. The Italian translation of this term - moderate) - has resulted in considerable controversy in Italy over what exactly this means (see below). Enforcement activity. Between 1955 and 1978, the Labour Inspectorate (Ispettorato del Lavoro)m as an office of the Ministry of Labour, decentralised to regional and provincial level, was the main body responsible for monitoring the application of labour legislation and collective agreements and the functioning of social insurance, welfare and health arrangements. In 1978, the Health Services Act (Law 833/78380) instituted the National Health Service structured in Local Health Agencies (L'unita sanitaria locale USL)381 at regional level under the Ministry of Health. In each USL, among the traditional health services (Aziende sanitarie locali - ASL), a unit for Occupational Health and Safety (Servizia di Preveraione e Sicurezza negli Ambienti di Lavoro PSAL) was established. The law gave some of the powers of the Labour Inspectorate to the PSAL. They were provided with regulatory powers on health and safety and enabled them to use these powers in addition to their preventive advisory activities (which were mainly oriented to support trade union actions in worksites based on Art. 9 of the L.300/70).382 The health and safety system was substantially reorganised as a result of efforts to comply with the EU Framework Directive and a somewhat more significant inspection role for the Labour Inspectorate was introduced in the late 1990s. The decree DPCM 14.10.1997 n.412383 identified a few higher risk sectors where control can be undertaken jointly by Labour Inspectorate and the prevention service of the USL for example in the construction industry. PSAL activities include:
http://www.area.fi.cnr.it/guests/prevenzione/capl.pdf. Legge 23 dicembre 1978, n, S33 'Istttuzione delServizio Sanitaria Nazionale'pubbticata sul Supplemento Ordinario delta Gazzetta Ufficiale n. 360 del 28-12-1978. Legge Regionale 17 luglio 1996, n. 26., Riordino del servizio sanitario regionale http://www.regione.marche.it/bur/96/53.2S07neggV2.html L. 20 maggio 1970, n. 300; Norme sulla tutela delta Hberta e dignita dei lavoratori, delta liberta sindacale e dell'attivita sindacale net luoghi di lavoro e norme sul collocamento http://www.dielle.it/Leggi/70-300.htm. Decreto del Presidents del Consiglio dei Ministri, Reingresso dett'ispettorato del Lavoro nell'attivita di vigilanza; http://www.626.cisl.it/doconline/Legislmione/Leggi%20Decreti/Dec%20pres%20consiglio% 20ministri.htm.
276 Beyond Limits
-
sectoral prevention plans controls on OHS legislation controls on medical surveillance carried out by the 'Competent Doctor' of the companies examining plans for the removal of asbestos preventive assessment of new activities, plants and work-sites criminal investigations on work accidents and occupational diseases providing information to workers on control activities giving information and training on legislation and authority policies to workers, trade unionists, employers and experts.
There are a number of statistics available on the extent of enforcement activity generally. However, none specifically relate enforcement activities to infringements of OELs. According to sources within the Labour Inspectorate Unit of the Ministry: '. . . data are not systematically collected. Regional Governments, such as in Tuscany or Emilia Romagna) may have databases on USL activities, that may include infringements related to chemicals.' However, such information is not collected systematically or published.
APPLICATION IN PRACTICE The introduction of OELs into the Italian regulatory system is a departure from traditional approaches. It is also a new development that is largely untested in practice. There are major concerns about the implications of transposition for the practice of risk assessment and its monitoring through the inspection activities of the regulatory authorities. Additionally the regulatory system itself is complicated by the role of the Ministry of Labour and Ministry of Health and the agencies under their separate control as well as by the regional variations in practice. In this section we consider some of the implications of this general picture for the practice of inspecting and controlling measures on chemical risks at the workplace level. We start with the structure of the system for inspection and control, followed by an outline of strategies for securing compliance and end with some of observations of participants on OELs and the efficacy of the system. The section is based mainly on interviews with regulatory officials, employer and trade union representatives as well as with representatives of structures created to support employers and workers in health and safety following the implementation of Decree 626.
Italy
277
The structure of the regulatory system. The National Health Service instituted in 1978 replaced previous employment-based health insurance schemes with a single national system. Reforms brought about by Law 833/1978 divided the management of occupational health into three levels of intervention. At national level, the Central State was responsible for national health planning, laying down uniform health and safety rules and approval of machines and equipment for accident prevention purposes. The Ministry of Health was invested with the powers previously vested in the Ministry of Labour and inspection functions of the Labour Inspectorate were transferred to the USL.384 This was a crucial point of the reform. From 1978 until the adoption of Decree 626, the Labour Inspectorate was virtually absent from the health and safety field. Inspection and control functions normally performed by the Labour Inspectorates in other countries were undertaken by inspectors from local health units (USLs). In addition the Higher Institute for Accident Prevention and Safety at Work (ISPESL) was set up by Presidential Decree 619 of 31 July 1980. ISPESL is managed on a tripartite basis. Its functions are to undertake research and to define criteria for the approval of industrial machinery and equipment. There are 36 ISPESL local departments working with the USLs. There are 19 Regions and two Autonomous Provinces. They are all entitled to adopt health legislation including provisions on health and safety at the workplace. Following the reforms introduced by Act 833 the health system was managed in highly diverse ways across regions. There are many factors that explain this variation at regional level. Among the most important are the varying degree of industrialisation, difference in the labour market, varying strength of the trade union organisations, as well as the political orientation of the regional authorities and the resources available. Obviously the feet that detailed national provisions were never adopted to operate Law 833 fostered even more regional variation. Observers have argued that the implementation of the National Health System gave rise to a double and contradictory effect. For example, according to Pelissero and Carreri (1997: 314): 'on the one hand, to place . . . . under the USL, all the services of prevention, care and rehabilitation induced a global and unitary vision of medicine. On the other hand, the fact that national programme and planning were never completed and USL: Unita Sanitarie Locali, Local Health Unit,
278 Beyond Limits that the Act 833 suffered from some technical shortcomings have given rise to an ever increasing 'regionalisation' of the organisational model. This led to the development of some 21 models of USL based on the regional laws adopted between 1978-1981.' The duties and functions of these services varied. Public hygiene, food hygiene and environmental hygiene could be found in all regions. Fifteen regions however, included developing the function of health protection in the workplace as part of the hygiene service (See Pelissero and Carreri 1997: 314 -316). It has been estimated that between 60 to 67 per cent of USLs provided a specific workplace preventive service. There were also 85 district preventive centres or services set up under the aegis of USLs in some regions. Staffed by a workforce of a little over 5,000 people, they had specialised laboratories for analysing physical and chemical factors and toxicological examinations. Their duties extended both to prevention at workplace and protection of the environment, and their activity was multidisciplinary to a high degree (See Vogel 1993: 308 and 313 In the late 1980s there were approximately 670 USLs operating at the local level, each covering a population ranging from 50,000 to 200,000 persons. At the beginning of the 1990s the National Health Service including the USLs was restructured. One aspect of this process was the requirement of Decree 502 of the 30 December 1992 for regions to reorganise and reduce the number of USLs until broadly, they corresponded to the number of provinces in each region383 (Pelissero and Carreri 1997). The implementation of this article reduced the number of USL to 228 in 1995. Article 7 of the Decree aimed to bring more uniformity to the regional systems as regard to prevention, monitoring, inspection, and health and safety at work. It specified that within the boundary of their competence, the Regions must establish within each USL a prevention department to carry out workplace prevention activities in accordance with Articles 16, 20 and 21 of the Act 833/1978.386 The setting up of prevention departments within USLs as well as the reorganisation of the USLs at provincial level constituted a major change. However, the preventive principles as well as the attributions and functions of these services remained the same. The public health system was still the main structure responsible for prevention activity in the workplace and once again, it was left to the Regions to implement the detailed operation of health reform and therefore capacity for wide variation also remained. 385
Each Region is subdivided into a number of Provinces. These are the main articles concerning prevention activities in the workplace and preventive
Italy
279
The transposition of the Framework Directive has modified but not entirely changed the involvement of public health structures in OHS. USLs are still provided with the power of the Labour Inspectorate in health and safety. Thus they have regulatory powers in health and safety and are able to use these powers in the workplace in addition to their preventive advisory activities. The Decree 626 provides that the monitoring of the application of the legislation on health and safety may also be exercised by the Labour Inspectorate, which will need to inform the prevention and safety unit of the USL at a territorial level beforehand. It also provides for the Ministry of Labour to ensure adequate co-ordination of all the levels of administration (national, regional and local) involved in the management of health and safety at work and the creation of a regional committee for co-ordination (Art.27) of all the OHS structures. However, in practice in most regions it appears that while the Labour Inspectorate has undertaken responsibilities for enforcing some aspects of the law on the terms and conditions of work and on issues of non-legal work,387 it has not engaged substantially in monitoring or enforcing compliance with occupational health and safety provisions. Nor has it made any substantial commitment to the training or employment of specialist inspectors for occupational health and safety. As we see below, the co-ordinating role of the Ministry of Labour at national, regional and local levels is problematic in practice because of its lack of engagement in operational aspects of the substantive issues involved. The implications of the structure of the regulatory system. The somewhat labyrinthine structure of the regulatory system, and the complicated distribution of responsibilities for policy and practice between the agencies of the Ministry of Labour and the Ministry of Health at national and regional level, are regarded by many as less than helpful for the promotion of a clear strategy on chemical risk. Moreover the dissociation between Ministries and agencies largely responsible for policy from those largely responsible for practice is another obstacle for the operation of strategic aims. The powerful role of the regions in implementation of the law is a further important complication, for although theoretically the Ministry of Labour has authority to implement the law, in practice this authority actually lies with the regions. At the same time, the Ministry of Labour retains a responsibility for much of the liaison between the Italian state and the European Commission on the creation, transposition and application of Directives on health and safety. It is also the architect of the national transposing measures (sometimes with other Ministries). The details of transposition are however the subject of negotiation between the regions and the national level. Constitutionally, the current system reflects It plays a substantial role in policing the illegal employment of immigrants for example.
280 Beyond Limits an approach in which it is accepted that minimum requirements will be defined by EU measures which may be taken further by national requirements and further still by requirements at regional level. This means that in some cases, such as with OELs, there are parallel developments in which national committees at Ministry level define technical policies while at the same time there are committees for consultation between regional and national level engaged in a similar task. Because of the importance of the regions in the application and use of the law, these regional committees and their recommendations play a significant role both technically and politically. In addition, because regions may introduce more rigorous measures than those required either at EU level or nationally and because there is enormous discrepancy between them, in terms of their prevention resources and policies, there is good reason to suppose that widely different standards may result. In practice, given the strong lobbying at national level by interest groups concerned with the costs of compliance, the likely practical and political result of the possibility of greater stringency at the regional level is greater pressure towards minimal standards at national level. In the case of OELs it is too soon to observe such outcomes as the process of their definition is still underway. Nevertheless, the text of the national provisions transposing the Chemical Agents Directive has been the subject of some controversy. There has been discussion concerning the retention of the substance of previous Italian requirements to reduce risks as low as is technically possible.388 But the main issue of debate seems to have concerned the definition of the level of risk at which employers are required to demonstrate that they have taken action. Clearly action is required at levels of high risk. The problem occurs in the terminology used to define the level at which employers are expected to assess risks taking into account the existence of OELs. This implies a requirement for monitoring and measurement that employers' organisations, especially those representing small enterprises, argue will place unacceptable economic burdens upon their membership. As a result they have focused on the meaning of the Italian translation of the term 'slight risk' that is used in the Directive, arguing that such onerous requirements on risk assessment do not apply to situations with such a level of risk. At the same time, trade unions and prevention specialists fear that if the level of risk at which action needs to be taken is set too high, then many workers will face unacceptable risks to their health. They are concerned that workers will experience a lower level of legal protection from their employers than that During a preparatory phase in transposition the principles of these articles were apparently inadvertently dropped. They have however subsequently been effectively reinstated with requirements on duty holders to maintain previous levels of prevention practice in relation to chemical risks.
Italy
281
to which they are entitled as a constitutional right - and which was provided to them under previous legislation in which all employers were required to reduce risks to levels that were as low as technically possible. This has therefore become a political issue that has been fuelled by an issue of translation in which the Italian transposition of the Directive's requirements implies that action is not required if risks are 'moderate". As we have noted, there are both Ministerial committees and those at regional level that are attempting to develop guidance on these issues. There is for example a technical committee with representation from the Ministries of Labour and Health and their agencies that is responsible for the implementation of EU indicative values. At the same time there are several technical working groups established by the Ministry of Industry and the Ministry of Labour, one of which is charged with defining risk. Parallel to these committees there are regional ones, indeed, by the time the technical working group on defining risk had held its first meeting the regions had already produced their guidelines. To avoid creating arbitrary distinctions between situations of 'low' or 'moderate' risks in terms of levels of protection required, the agreed aim of the guidelines from all these committees is to achieve a high protection of workers without the need to measure levels of chemical pollution in the workplace. This means producing methods which allow effective risk assessment to be undertaken to certain levels that does not preclude measurement but does not make it an essential requirement of the process. This is why the retention of former legislative principles of reducing risks to as 'as low as technically achievable' is regarded as important since such principles avoid imposing demarcation lines between situations in which risk is legally defined as requiring certain types of action and those where no action is required. Strategies for securing compliance. The different government ministries involved and the devolution of authority to the regions makes for a complicated system that results in more than a degree of obfuscation of strategy, confusion for its intended targets and many opportunities for debate and disagreement concerning both the aims and application of strategies on chemical risks. Interviews with officials with responsibilities for securing compliance from different USLs in regions in the north of Italy389 conveyed a general picture of practice in which Although there are great differences in the role of the prevention departments in USLs in the south of Italy and those of the north, it is unlikely that officials from USLs in the regions of the south of
282 Beyond Limits the traditional requirement to reduce risks as much as was technically possible was preferred to a system in which OELs played a more pivotal role in determining the nature of compliance strategies. As the transposition of the relevant EU Directives on chemical risks is a very recent development and their operation still largely under discussion, this is perhaps not surprising. However, it also reveals that inspectors share some of the concerns about the new system. That is, they are worried that the existence of an OEL will act negatively on the will of some employers to reduce exposure to as low as technically possible, even when they have the capacity to do so. In this respect they are concerned that the existence of an OEL for particular substances will reduce the discretion of the inspector and especially his/her authority to require employers to reduce exposures to levels the inspector feels to be technically feasible. Moreover, there is a strongly held view that a 'one value* OEL regardless, of the documentation that might accompany it, will be interpreted as a 'safe level', and that this will be exacerbated by the definition of risk in the legislation. It is felt that the use of terminology such as 'moderate' risks as levels below which monitoring activities may not be required, will be interpreted in ways which will effectively mean that employers will believe there is no requirement for any preventive action to be taken in such circumstances. Again this is perceived to make the inspectors' tasks of advising and persuading employers to adopt best practice approaches to prevention more difficult. All these concerns were shared by workers' representatives and trade union officials, as well as by the representatives of unilateral and bilateral OHS information and advisory agencies interviewed. While these individuals all had different perspectives resulting from their particular roles in occupational health and safety, they were nevertheless broadly of the same view regarding a perception of the legislation as requiring an 'all or nothing' response that was based around a rather arbitrary definition of risk, which in practice would do little to encourage many employers to reduce risks to levels they would be technically and economically capable of achieving. This of course is the obverse of the concerns also expressed by organisations representing the interests of the owners of small enterprises, who fear that those enterprises that fall into the higher risk category will by definition be required to invest in monitoring procedures regardless of the realities of the risks actually experienced at their workplaces.
Italy would have adhered to a more rigorous or technical use of OELs in their inspection strategies. It is widely accepted that the structure, resourcing and practice of inspection and control in OHS is southern Italy is generally much weaker and more erratic than that found in the industrialised regions of central and northern Italy. The interviewees all came from USLs in the northern regions and therefore probably represent 'best case' practices.
Italy
283
Inspectors' approaches to seeking compliance in enterprises in which chemical substances with OELs are in use are based around first checking the extent to which risks had been assessed through the examination of documentation. They then may consider the features of the workplace such as for example, its design, the use to which it is put, work practices, the quantities of substances used or released and the engineering controls that are in place to reduce exposure. If the inspector is not satisfied with the existing arrangements s/he may require the employer to present a prevention plan in which information on what practices, procedures or designs are to be introduced to assess and control risk. The requirement for a prevention plan/risk assessment could include providing information on exposure levels to substances with OELs, that would mean employers would need to measure (or contract someone to measure) chemicals in workplace air. Inspectors have the power to require such measures and/or to supervise their collection or undertake the measurement themselves. However, generally measurements are not required. Priority is given to inspection activity in workplaces where actions are most likely to be needed. Here it is normally not necessary to measure airborne contaminants in relation to their OELs since it will be obvious that OELs are being exceeded or there are other obvious problems that imply they will be exceeded. Recent strategies in some regions have resulted in more targeted inspection in which particular sectors and processes are studied in greater depth. This has been made possible by the recognition that the basis of the Italian economy is the structured network for production amongst small enterprises engaged in similar tasks and using similar processes that characterise many industrial sectors and which is evident at local levels. OELs and measurement of chemical contamination of workplace air are relevant to these strategies. Generally however, because there is an association between the notion of OELs as legal requirements and the formal enforcement role of inspectors, they are not much used in targeted strategies. The emphasis of the USL inspectors is to develop strong working relationships between employers, workers and their representatives, the regulatory authorities and other participants in OHS at local levels, hi these relationships, which are predicated on developing trust between participants, USL inspectors are at pains to project their advisory role rather than that of formal enforcement. Examples of this approach at local sectoral levels include the involvement of inspectors in projects on wood-dust and on lead and other toxic substances in ceramics, in work in the meat industry and in asbestos removal. Here a more holistic
284 Beyond Limits approach to control is sought in which for example, engineering control, control at source or (as in the case of wood-dust) controls built into the manufacture of machinery before it enters the workplace (and thus, specification standards), are the focus of discussion, rather than compliance with OELs. In some of these examples an agreed protocol for good practice at local (district) level, to which employers and other participants adhere in workplace practice, is the desired outcome. Here again, the perception of the OEL as a measure that implied a fixed environmental standard to be achieved regardless of variations in workplace realities, is seen as too rigid to allow the flexibility of practical control solutions to the exposure of individuals that could be achieved through agreeing a general protocol for good practice in relation to specific processes. In this approach, inspectors recognised that there are always likely to be some employers who Ml to participate or comply with such a protocol. However, they believe that if a critical mass of enterprises in a local area have agreed to implement a protocol concerning a particular issue such as the use of wood-working machines for example, the peer and economic pressure that this has on all the relevant firms in the area is such that it is more likely to achieve overall improved OHS performance than would otherwise be possible. It also allows the bad performers to be more readily identified and for more formal enforcement techniques to be used against them. Moreover, in the case of subsequent legal proceedings such protocols may be helpful in informing legal decisions about practicable prevention practices for the sector. Amongst the USL inspectors as well as among other participants interviewed there was a perception that exposure limits were more of a prominent issue in the debates of the 1970s than they have been in more recent times. For example, pressure for the adoption of the ACGIH list into the collective agreements in certain sectors such as the chemical industry dates from this period. Some inspectors also expressed an impression that less rather than more measurement of workplace air pollution in relation to OELs was currently conducted than had been previously. It was further suggested that the increased role of OHS consultants resulting from the requirements on prevention services that were introduced by Act 626 had not really contributed to greater facilities for measurement since many such consultants had neither instruments nor skills to undertake proper occupational hygiene practice. Therefore, although it was felt that one of the effects of the measures to transpose the Chemical Agents Directive may be increase the pressure to require some employers to undertake monitoring, the extent to which commercial prevention services had the capacity to do so was doubtful. It was feared that the effect of this would be to create a double standard - one for those employers who could afford to take appropriate monitoring actions either themselves or with the aid of qualified and competent prevention services - and another for the rest.
Italy
285
Interviews with workers' representatives and their trade union officials tended to bear out the impressions given by the USL inspectors concerning the use of OELs. For example, workers' representatives believed that national level OELs were a necessary means of alerting participants to the existence of a problem that required attention. Thus it was suggested for example by workers' representatives from the metal and chemical manufacturing sectors, that in their experience the main value in the adoption of the ACGIH list in collective agreements, was that it drew their attention to substances that may be in use in their workplaces and for which they needed to obtain appropriate information. The worker representatives from these sectors who were interviewed were unaware of any widespread use of OELs in enforcement, despite their inclusion in collective agreements. In contrast, they were able to point to numerous examples of their own experiences in which the existence of the list had prompted them to seek information on particular substances in use in their workplace or about to be introduced there. They were able to give further details of the results of the follow-up to these actions in which, by negotiation, employers had agreed to modify processes or substitute 'safer" constituents. They spoke of USL inspectors being involved in separate discussions with the employer on the same issues in some cases but did not perceive measurement and monitoring of the relevant OELs to have been of central interest. The strong impression from these interviews was that the role of OELs was somewhat peripheral in the daily realities of the worker representatives' experience. Subjective perception of risk was far more significant. It was this subjective perception that instigated bargaining for better working environment or changes in work organisation, not the technical measurement of risk. They also pointed out that since inspection only reaches a minority of workplaces, the trade union role extended beyond the confines of the large workplaces (in which there was strong worker organisation on health and safety) to smaller, less well-organised workplaces in the same sector in which trade unions could bring pressure to bear through the adherence to the principles enshrined in the collective agreement. In this sense they provided another side to strategies described above in which the USL inspectors sought to achieve agreed protocols on OHS matters which would have more widespread effect in the sectors in which they were established than could be achieved through inspection alone. Thus the worker representatives confirmed, from their own perspective, the USL inspection approach. It is noteworthy that from either perspective, OELs do not play a prominent role. They are not a main focus for compliance strategies even when such strategies deal with subjects such as reducing risk from exposure to substances such as wood-dust which have featured prominently in international debates on setting and using OELs.
286 Beyond Limits
CONCLUSIONS
The implementation of the Chemical Agents Directive poses some major challenges to the Italian system. It is not yet clear how these will be resolved. Transposition at the national level has engendered considerable debate. At the local level there is little sign of compliance strategies that place OELs in a central position, either from duty holders, workers and their organisations or the authorities for inspection and control. While representatives of all these players have quite strong views on the national debate, it is not obvious how these relate to local level experience. These are concerns on the part of smaller enterprise owners over financial implications of measurement. Trade union representatives and inspectors have concerns that setting both single limit OELs and action levels according to the proposed definitions of risk will, in practice, have a negative effect on the willingness of many employers to follow best practice and reduce exposures to as low as technically possible. There seem to be some major questions over what is being achieved by the introduction of the EU measures on OELs into the Italian system. Trade unions argue that such limits are not the truly health-based values they seek. Employers' organisations fear that their adoption will require their members to invest heavily in the use of expertise to monitor workroom air which, in the main, will be well within the relevant OEL. Inspectors, trade unions, and OHS professionals are all concerned that the national definitions of risk that are set to determine the extent to which duty holders are required to take action will have the negative effect of allowing many employers to believe they need do nothing, which in turn will make it harder for inspectors to require that they reduce risks to as low as technically possible. OELs probably have some value at national or sectoral level as indicators of risk associated with exposures to some substances. As such they are useful in raising awareness of the possible need for action at local level. But at the local level, practical realities are such that improvements in OHS management are normally effected by means that neither require, nor overtly involve, the use of OELs. Therefore it is arguable that the connision and obfuscation introduced by the current state of the transposition of EU measures on chemical risks, could well be greater than the benefits such measures seek to achieve. However, this also needs to be seen in the context of the general features of the Italian system. One of its characteristics for example, is the great variation between regions.
Italy
287
Since practices described by interviewees in the present study were all drawn from the industrialised northern regions - which are widely acknowledged as being comparatively well developed in terms of OHS provision and practice - they are not typical of Italy as a whole. Indeed the absence of input into the present study from representatives from regions in the South is largely a reflection of the lack of resources for health and safety in these regions. It further reflects their lack of engagement in issues at national level such as the development of guidance on transposition of the Chemical Agents Directive. It may be that national measures therefore do serve as a useful guide. They may not have a great deal to offer regions in which good practice in OHS prevails, supported by relatively well resourced prevention departments of USLs, and bilateral information and advice structures, as well as by informed trade union representatives. Nevertheless, they are perhaps a useful baseline for the country as a whole since the law allows regions to develop better practices but theoretically at least, it does not condone the implementation of lesser ones.
This Page is Intentionally Left Blank
289
8
THE NETHERLANDS
INTRODUCTION The Dutch chemical industry is not as large as that in Germany, the UK or Italy, however in relation to the working population of the Netherlands it not insignificant. Nor of course is exposure to hazardous chemicals limited to employees in the chemicals industries, as we have pointed out in previous chapters on the other countries in the study. Indeed, the Netherlands was chosen as one of the countries for more detailed study because its policy on regulating the management of chemical risks at the workplace is widely held to be highly developed and innovative. It is a policy that has developed as a result of a long-standing and active interest in improving the work environment in relation to the use of chemical substances that has been shared by trade unions, industry and the state. Despite (or perhaps because of) such engagement, according to the European Foundation's Third Survey of Working Conditions, Dutch respondents generally thought themselves slightly less well informed about the risks resulting from the use of materials, instruments and products at work than the average for the EU 15.390 At the same time they regarded themselves less exposed to breathing in vapours, fumes dusts or dangerous substances than the average for the EU 15 as a whole and less likely to handle dangerous products or substances.391 73 per cent of Dutch respondents regarded themselves as fairly well or very well informed about the risks from their use of materials instruments or products in their job compared with 76 per cent of respondents in the EU 915) countries overall. 14 per cent of Dutch respondents thought they were exposed to breathing in vapours, fumes dusts or dangerous substances (compared with 22 per cent of the EU 15 respondents as a whole) and 11
290 Beyond Limits Special features evident in the approach to both setting and using OELs include: -
involvement of trade unions and employers" organisations and representatives of the state a relatively long history of engagement hi standard setting extensive arrangements to distinguish between health-based criteria and the use of economic and technical considerations to agree limits.
At sectoral level the Dutch approach to chemical hazards is distinguished by the particular prominence of the debate on substitution and the strategies to achieve this in certain sectors, as well as by the recent emphasis on the use of convenanten (covenants) to set agreed sector specific targets for improvement of the work environment - which in some cases, include agreement to improve on OEls. At workplace level several features have a bearing on the approach to dealing with chemical hazards. They include: -
statutory requirement on employers to contract with occupational health services to provide them with expertise in risk evaluation and control the role of workers' participation through works councils in arrangements for health and safety strategies of the labour inspectorate to promote and support a systematic approach to occupational health and safety management.
To understand the significance of all these developments for the role OELs play in strategies to achieve compliance and their relationship to features of the wider regulatory system, it is necessary to consider a little of the context in which they occur. This means outlining the regulatory framework within which OELs are established and used and some of the political and socio-economic background to its recent development. We therefore begin this chapter with a brief overview of relevant elements of the Dutch approach to regulating the work environment before turning our attention to the more specific issue of the role of OELs in the process of managing chemical risks. Here we evaluate the significance of the above features of the Dutch approach to the management of chemical risks and also take into account the impact of recent shifts in the politics of health and safety in the Netherlands.
per cent said they wsre exposed to handling dangerous products or substances compared with 16 per cent in the EU 15 sample as a whole.
The Netherlands 291
THE INFRASTRUCTURE AND PROCESSES INVOLVED IN SETTING
OELs Regulatory system and responsible bodies. The responsibility for establishing occupational health standards lies with the Ministry of Social Affairs and Employment (Ministerie van Sociale Zaken en Werkgelegenhei)Jm Within the Ministry, the Working Environment Directorate of the (Directorate-general Working Environment and Social Security (Directoraat-generaal Arbeidsomstandigheden en Sociale Verzekeringen (DG ASV) ) is responsible for health and safety including occupational exposure limit values. In the Netherlands, working conditions are regulated under the Working Environment Act (Arbeidsomstandighedenwet - Arbowef9*), which is a framework act on the basis of which further decisions and regulations can be made.394 Such regulations can be found in the Occupational Decision (Arbobesluit 199719i) and the Occupational Regulation (Arbeidsomstandighedenregeling 1997 - Arboregeling 199739S). The legal basis for establishing OELs or MAC values as they are called in Dutch (Maximum Allowable Concentration or Maximaal Aanvaarde Coneentraties) is laid down in Article 4.9 and 4.16 of the Arbobseluit. The values themselves are found in: -
Bijlage VI behorend bij artikel 4.19 eerste lid, Lijst van wettelijke grenswaarden op grand van artikel 4.9 van hetArbeidsomstandighedenbesluif7 — Bijlage VIIbehorend bij artikel 4.20, eerste lid, Lijst van wettelijke grenswaarden voor kankerverwekkende stoffen op grand van artikel 4.16 van het Arbeidsomstandighedenbesluit
http://home.szw.nMralex/dsp_index.cftn. Wet van 18 maart 1999, houdende bepalingen ter verbetering van de arbeidsomstandigheden (Arbeidsomstandighedenwet 1998), Staatsblad No. 184 f http://www.xs4all.nl/~wilcodeb/arbol99S.html This is the Dutch legislation that implements the European Framework Directive. Besluit van 15januari 1997, houdende regeh in het belong van de veiligheid, de gezondheid en het welzijn in verband met de arbeid (Arbeidsomstandighedenbesluit: Staatsblad N° 60 I http://m.osha.eu.int/content/network/szw/docs/arbobesluil'wijzdging_09_mei_2000.pdf. Staatsblad 1997, IT 631 htrp://nl.osha.eu.int/contenl^network/szw/docs/arboregeling/arboreg_l.pdf. http://nl.asha.eu.iat/contenfnetwork/szw/dacs/grenswaarden.pdf.
292 Beyond Limits -
Bijlage 6 behorend bij beleidsregel 4.2 -1 Arbobesluif""
Occupational Exposure Limit Values are established through a three-stage consultation procedure involving three main institutional consultative structures: -
Dutch Expert Committee on Occupational Standards (DECOS).399 A subcommittee of the Health Council of the Netherlands (the independent scientific advisory body for all Ministries dealing with public health issues400 *" 402 M3) since January 1994, The DECOS-Committee informs the Ministers of Social Affairs and Employment of the harmful consequences of exposure to toxic substances in the air in the workplace. The members of the DECOS are experts from research institutes, universities, ministries and industry, who participate in the Committee on a personal basis.
-
Subcommittee on MAC values of the Social and Economic Council."* Composed of: six employers' representatives, six employees' representatives, one independent member (chairman), two advisory members (from DECOS), and six ministerial representatives. In principle, the Sub-committee meets every month.
-
Social and Economic Council (Sociaal-Economische Raad - SER).m m The Dutch government's main advisory body where social and economic matters are concerned. It is a tripartite body, comprising employers' representatives, workforce representatives and crown-appointed members (economic, financial, legal and social experts appointed as independent members by the Head of State and the Cabinet).
http://www.fcv.nl/702werkgeld/arbo/themas/gevaarlijke-8toffen/7staffen.html. http://www.gr.nl/overig/standing%20committees/DECOS.htm. http://www.gr.nl/engels/heaIm%20council/Mstory/frameset.htin. http://www.gr.nl/engels/healm%20eouncil/mission/ftameset.htm. http://www.gr.nl/engels/health%20council/domain/frameset.htni. http://www.gr.nl/engels/health%20council/organization/framesethtni. http://www,ser.nVoverdeser/default.asp?desc=connnissies_10_5. http://www.ser.mYoverde8er/default.asp?desc=en_index, http://www.ser.nl/overdeser/default.asp?desc=overdeser_mac_waarden_inleiding.
The Netherlands
293
OELs are confirmed by and published by the Ministry407 and where relevant, become legally binding as a result. The Labour Inspectorate, as part of the Ministry, is responsible for surveying and enforcing the OELs."08 Character of OELs. The Netherlands has two types of MACs409 4ro "" m : legally binding and administrative (non-legally binding) OELs (Feron 1994). Both take account of socio-economic feasibility. Binding limit values are established for both noncarcinogenic and carcinogenic substances. Administrative values are only established for non-carcinogenic substances. A MAC value is defined as time-weighted average over an eight-hour period. Substances which can easily be absorbed by the skin are assigned an 'H'. For these substances, additional protective measures have to be taken. Specific rules apply to respiratory dusts and fibres. Short-term exposure limit values are established for certain substances for a 15 minute period (up to ten times the MAC value for non-carcinogenic substances and up to two times the MAC value for carcinogens). In addition, some substances are assigned a ceiling value ('C'), which should not be exceeded at any time. The MAC values are expressed in mg/m3 and established at a temperature of 20°C and a pressure of 1013kPa. Procedure for setting of OELs.4" ni 4l5 Until 1977, the US ACGIH TLV list was used in the Netherlands. In 1978, the Directorate-General of Labour of the Ministry of Social Affairs and Employment (MS AE) published the first official list of MACs, which was similar to the ACGIH TLV list of 1977. Since 1978, new MACs and changes in existing MACs have been established in the Netherlands according to the following three-step procedure: -
407 408 409 410 41
'
412 413 414 415
In the first step a scientific evaluation of the data on the toxicity of the substance is made by DECOS. This evaluation should lead to a draft report for a healthhttp://www.gr.nl/overig/standing%20committees/DECOS.htm. http://www.niinszw.al/Documenteii/Iiiformatie/Arbo/arbeidsinspec/arbeidsmspec.htm. http://www.bbzmv.nl/arbabvi.htm. VJ. Feron: op cti. http://nl.osha.eu.intj'content/network/szw/docs/grenswaarden.pdf. http://www.bbzrhv.nl/arbobvii.hmi. http://www.industox.nl/MACcie2000/sld005.htm VJ. Feron: op. cit. http://www.minszw.nl/Documenten/Nieuws/nieuwsberichten/pbOO/00215.hmi
294 Beyond Limits based recommended occupational exposure limit value (HBR-OEL), using the no-observed-adverse-effect level (NOAEL) approach in combination with an "uncertainty (or safety) factor' (UF). Draft recommendations of DECOS are published as soon as the Committee reaches consensus. In this way, third parties are given the opportunity to submit comments on its content. The deadline for comments is approximately three months. The Committee takes the comments into consideration in establishing the definitive advisory report. This first step is only performed for legally binding OELs (MACs). For legally non-binding, administrative OELs, the Social and Economic Affairs Council uses values and data from other countries (e.g. ACGIH) as the basis for the second step.4'6 - In the next phase of the three-step procedure, the health-based recommended exposure limit is assessed for technical and economic feasibility by the MACValue Sub-Committee of the Social and Economics Affairs Council. Based on the results of this study, the Council either advises the Minister and State Secretary for Social Affairs and Employment to adopt the health-based recommended exposure limit or it recommends a different value. — In the third phase, the Secretary of State determines and publishes the limit values either as legally binding values or non-binding administrative reference values. For substances that are classified as carcinogens Category 1 or 2 by the European Union (Directive 67/548/EEC) or by the DECOS-Committee and which, in addition, probably also have a genotoxic effect, a risk evaluation is carried out by the Committee. At the request of the Minister of Social Affairs and Employment, the committee derives socalled health-based calculated - occupational cancer risk values (HBC-OCRV) for these substances. The HBC-OCRV enables the calculation of dose levels and air concentrations associated with reference cancer risk levels for the occupational situation. In its reports on individual genotoxic carcinogens the Committee presents the concentration levels associated with excess cancer mortality at levels of 4 per 1000 and 4 per 100,000 as a result of working life exposure. To estimate the additional lifetime risk of cancer in humans exposed at the workplace, i.e. to calculate the HBC-OCRV, the committee assumes that workers are exposed five days per week, eight hours per day, 48 weeks per year for 40 years. They are expected to inhale 10m3 of air during eighthour working day. This advice also results in a legally binding MAC- value (see below).
Information provided by a member of Health Council.
The Netherlands
295
Discussion at national level: theory versus practice. Several issues have been prominent in national level debate on OELs in recent years. In common with experience in some other countries, a major criticism of the current system is that for the majority of the substances dealt with at the workplace, no exposure limit value exists at all. For others, the basis on which their OELs have been established is too old. A large number of current OELs were adopted Scorn the ACGIH list of Threshold Limit Values in the 1970s (around 300 substances - these values are currently under review). There are studies indicating that for more than 10 per cent of the over 650 entries in 2000 the OEL was too high from a health protection point of view, with deviations ranging from a factor of 2 to 250. For around another 100 substances the toxicological database was judged to be too poor to recommend a health-based OEL. Another criticism is that the complete procedure starting from the inclusion of a chemical in the working programme of DECOS to the official publication of a new MAC value by the Ministry of Social Affairs and Employment takes too long - an average of three to four years per substance. In addition, the simultaneous exposure of workers to a variety of chemicals is not taken into account. The toxicity of a mixture is not only determined by the toxicity of the individual compounds but also by combination effects. Traditionally, toxicological studies for the assessment of hazards to health, as well as the setting of such standards as TLVs and MACS, have focused on single compounds. Other factors which are not really considered when establishing OELs in order to keep the whole procedure as simple as possible are: -
-
longer (or shorter) working days than those on which the standard is based differences in reaction that the human body may display depending on whether the exposure took place during the daytime or at night (these differences are of relevance to shift work, for example, but would severely complicate the method) gender or age aspects (despite certain protective measures for pregnant workers or young people).
Therefore, the safety that MAC values appear to offer is considered to be to some extent illusory. As one consequence of the weakness of the existing system, negotiations between the trade union confederation, FNV and Dutch employers resulted in an agreed framework on maximum acceptable occupational risk levels for non-substitutable carcinogens, values that are now applied across the board to materials in the Netherlands. For the trade unions, the agreement meant 'getting their hands dirty' as they had to accept a specific risk of fatal disease incidence among workers involved
296 Beyond Limits (Wilders 2002). However, the agreement had the advantage of replacing the previous, ad hoc substance-by-substanee approach to carcinogen control in the Netherlands and produced recommendations for limits that are stricter than those promulgated by other agencies. Based on this agreement between the social partners, the government asked DECOS to provide their future recommendations with two time-weighted average limits for the carcinogenic substances under consideration: one based on a residual risk of 10"6 fatalities/year and one based on 10"4 fatalities/year.
POLITICAL AND LEGISLATIVE CONTEXTS 417 The organisation of Dutch society and its economy has for many years been considered to be strongly corporatist in character with little inclination to formalities and bureaucracy. Its present day version, the so-called poldermodel or overlegeconomie (Consultation Economy)418 is based on ongoing processes of consultation and negotiation between the social partners at different levels and between the government and the social partners at central level. This form of corporatism has in the past recognised the primacy of collective bargaining at the sectoral level. In theoretical terms, it has been represented as bargained corporatism characterised by positive-sum strategies, resulting in a large measure of consensus and a trade off between economic and social policy objectives (Crouch 1994). Thus, the role of bipartite and/or tripartite agreements to elaborate or complement legislation or to avoid statutory regulation is prominent in the field of industrial relations and labour law. Implicitly, collective bargaining agreements are framework agreements, creating room and latitude for interpretations, adjustments and elaboration at the company level. This concept of tailor-made policy has pervaded OHS legislation and the means by which it is enacted. The national Socio and Economic Council is a central level important structure within which the corporatist approach to health and safety matters is undertaken, with membership including representatives of the larger confederations of employers and workers and a special committee on OHS. A subcommittee of the Council deals with setting OELs.
This section is largely based on Poptna et al in Walters (ed) (2002). On the Dutchpotdermodel cf. Visser and Ilemerijck (1997). The question remains however if the Dutch system is really a distinct 'model'. Other countries, e.g. Denmark, share many of the Dutch characteristics.
The Netherlands
297
Parallel to this corporatist approach, was a highly developed system of social welfare in which, from 1967, the principle of risque social has been used in preference to risque professionel in disability and absenteeism benefits. In the mid 1980s alarmed by the escalating economic cost of benefits, the Dutch government embarked on a reform of the social security system. The reforms included cut backs on social security expenditure, with the dual purpose of both contributing to the government's efforts to reduce state expenditure and to serve as an incentive to increase labour participation rates. The policies behind these attempts to reform social security have also driven parallel reform in the regulation of preventive OHS management, such as the introduction of risk assessment and the role of occupational health services in undertaking assessment and in advising employers on preventive options.*19 Employers are expected to have an incentive to improve the work environment in order to avoid higher premiums or to reduce financial risks related to high rates of absenteeism and disability. Greater neo-liberal emphasis within these strategies has been the result of recent political changes in the country and the role of the market and of voluntary initiatives have been emphasised in parallel with further withdrawal of the state from direct engagement with regulating the work environment. Legislation. The process regulation that characterises modern Dutch health and safety legislation begins with the Arbeidsomstandighedenwet (Work Environment Act, WEA 198pmpnt party to agreement More generally, the extent to which workplace structures and practices match the social dialogue at sector level on both substitution and agreed convenanten and are in practice able to achieve the performance objectives set sectorally is not entirely clear. However, this does not necessarily imply underperformance - the approaches at sectoral level are themselves new and in many cases themselves not yet finalised therefore it may be too early to see clear operational results.
319
SWEDEN
INTRODUCTION The Swedish system for regulating the work environment is traditionally perceived as amongst the most conceptually advanced and well resourced in Europe and a prime example of the Scandinavian approach to the subject. It has a relatively long history of setting and using OELs and from the 1960s until the present time has set exposure limits and used them in the determination of acceptable standards of occupational health and safety (OHS) management practice in workplaces. Moreover, the levels at which these OELs have been set are amongst the lowest internationally and within the Swedish system for setting them there is a long established separation of decision-making structures on scientific issues from those that include economic and other concerns. For these reasons it seemed appropriate to examine its operation, to consider how OELs are used and how they relate to the wider system for regulating the work environment in Sweden. Generally, the features of the Scandinavian approach to work environment regulation include an emphasis on consensus and on corporatist decision-making at national and sectoral level, support from a comparatively highly developed provision of external prevention services and strong representative participation in activating health and safety at the local level. From the early 1990s in Sweden such approaches at the level of the workplace were embraced by the term 'internal control" in which a systematic approach to participative OHS management was envisaged in clarifying responsibilities and obligations of employers as responsible and accountable subjects. More recently this approach has been slightly modified and renamed 'systematic work environment management' but remains as the name suggests a systematic approach to participative OHS management.
320 Beyond Limits
While some Swedish observers suggest that Sweden is not immune from the impact of neo-liberalism and as a result post-2nd World War corporatist tradition is less in evidence in current practice than in the past, OELs are nevertheless established within a corporatist national and sectoral environment and function in workplaces where ideally there are well established participative structures and procedures in place which, with the support of external prevention services, contribute towards employers* delivery of the systematic management of the risks of hazardous substances. Of course, the Swedish health and safety system and the role of OELs within it does not exist independently from the wider political and economic setting in which it is located. This wider system is far from static and as is the case in most developed market economies, it has undergone considerable change in the recent past. Such change has taken place not only in the structure and organisation of work but also in policy concerning workability, the economics of work-related well-being and the comparative role of the state and the market in its regulation and governance. These changes have had an impact at many levels and one of the aims of the present chapter considers some of their implications for the role of OELs as instruments in supporting the systematic management of the work environment. To achieve these ends the chapter begins with a brief outline of the economic and legislative background to the Swedish approach to regulating chemical risks and policy and practice in relation to achieving compliance with systematic health and safety management requirements. This is followed by some observations concerning the setting and role of OELs in the process of regulating health and safety management. Beginning with an outline of the theoretical position concerning the use of OELs, we consider the extent to which OELs and monitoring compliance with them actually form part of systematic health and safety management of chemical risks in practice. In so doing we discuss the main issues for the role of OELs in achieving compliance with measures to regulate the management of chemical risks.
THE USE OF CHEMICAL SUBSTANCES AT WORK IN SWEDEN The Swedish chemical industry plays a relatively small part in chemical production of the European Union as a whole. Nevertheless the use of hazardous chemical substances is as widespread in Sweden as in all the other countries in the study. Eighty per cent of the Swedish respondents to the European Foundation survey considered themselves very well or fairly well informed about risks resulting from the use of materials,
Sweden 321
instruments or products at work, compared with 76 per cent for the EU 15 countries as a whole. A slightly greater percentage of Swedish respondents felt they were exposed to breathing in vapours fumes dust or dangerous substances for at least a quarter of their working time (24 per cent) than the average for the EU 15 countries as a whole (22 per cent) but slightly fewer reported handing dangerous products for more than a quarter of their time at work (13 per cent compared with 16 per cent for the EU 15 average).
ECONOMIC AND LEGISLATIVE BACKGROUND*" Swedish regulation of OHS management follows a Nordic approach that has largely paralleled regulatory developments in the EU, but which was initiated prior to Swedish membership of the Community. The term characterising this approach during the 1990s was 'internal control' . In July 2001 it was slightly revised and renamed 'systematic work environment management' (AFS, 2001). As in other countries, the evolution and implementation of regulating OHS management is embedded in national politics, the economy, labour market and industrial relations (Frick 2002). A strong Social Democrat tradition dominated Swedish governments from 1932 to 1976, Welfare policies and their implementation have been much influenced by interest organisations, especially the trade unions (which have an unusually high membership rate of over 80 per cent). There is therefore a long history of participation of organised labour in economic and social policies. Such corporatism was underpinned by the agreement reached in 1938 at Saltsj8baden, between the main trade union confederation (LO) and the employers' organisation (SAF) (Johansson 1989, Sund 1994). However, since the 1970s both politics and the economy have become more volatile. Although modern Swedish politics has been dominated by Social Democrat governments, between 1976-82 and again between 1991-94 coalitions of centre-right parties held office. During recent decades the mode of governance has shifted towards decentralisation and market solutions with movement away from Keynesianism (Ryner 1993). Much of the formal corporatitist structure was dismantled when the main employers' organisation (SAF) withdrew from most of the boards of government authorities in 1993. Yet, like the rest of the so-called 'Swedish Model', labour market corporatism has not disappeared entirely. Unions and employers still control some
For a more detailed description of the main points contained in this summary see Frick (2002).
322 Beyond Limits
formal structures and an extensive bipartite co-operation on several issues still exists, especially on OHS. Many working conditions are still regulated in collective agreements, which in other countries are, by law, individual rights (Bruun 1994).
THE SWEDISH APPROACH TO REGULATING THE WORK ENVIRONMENT The legislation. The Work Environment Act of 1977 initiated modern approaches to OHS legislation. It covered practically all employees, made employers responsible for their health and safety at work and emphasised preventive local OHS activity in which workers were to participate, through dialogue with their supervisors and through their union appointed safety representatives (see Hyden 1992 and Vogel 1998). It also broadened the definition of OHS to include organisational aspects and it confirmed the gradual shift in preventive principles from behaviour control to technical prevention. OHS requirements were further specified by mandatory ordinances including standards on new hazards and stricter requirements on old ones. The National Board and the regional Labour Inspectorate received greater resourcing and the number of inspectors grew from 175 in 1967, to around 450 in the mid 1980s who visited nearly 60,000 workplaces per year (AV 1989). Internal control. Concerns about the efficacy of the system led to further changes in the Work Environment Act with the introduction of "internal control* in an ordinance (AFS, 1992) originating from 1991. Internal control (IC) duties of employers included, among other things, requirements to: -
-
integrate a systematic approach to the work environment as a natural part of dayto-day activities give the employees, safety delegates and pupil safety delegates the possibility of participating in such a systematic approach (though the forms and rights of employee participation are specified in older regulations) establish objectives for the IC continuously assess the risks of the operations and abate them list necessary OHS improvements, which can not be abated directly, in yearly action-plans allocate tasks, responsibilities and resources to prevent ill health at work ensure that managers and workers have the necessary OHS competence audit the effectiveness of the IC and make necessary revisions annually.
Sweden 323 Though the EU Framework Directive was hardly mentioned in the reform process, by introducing internal control, Swedish OHS regulation complied with nearly all of the Directive's articles and exceeded them with its requirement of an annual audit of the adequacy of the IC. In 2001 further reforms were introduced developing internal control into systematic work environment management in keeping with EU requirements and aimed at making such management an integral part of everyday work. Assessment by the Labour Inspectorate provides an indication of how far systematic work environment management (SWEM) has been implemented. According to a report from the Work Environment Authority published in 2003,442 about 40 per cent of employers claimed that SWEM had been introduced in their workplaces and was functioning well. Some 65 per cent said they had investigated the work environment and made a risk assessment while 70 per cent said they had a good or very good knowledge of SWEM.443 hi 2002 labour inspectorate estimates of compliance with systematic health and safety management requirements indicated it believed 50 per cent of firms were in fact meeting their statutory obligations in this respect (WEA 2002). However, other studies, which have compared the Labour Inspectorates' assessments with 'expert' evaluations, indicate that the inspectors may be too lenient in their own assessment of the extent of compliance. In an analysis in 2000 for example, it was suggested that according to more stringent criteria of what constitutes a fully functioning OHS management system, only 2 per cent of the assessed workplaces actually had one in place (Frick 2002:228). Arguably, the 'true' compliance rate is likely to be between these figures, but still indicates that ten years after the mandating of internal control at least half of Swedish workplaces (and probably many more) do not comply fully, despite its role as a strategic instrument in the Swedish OHS system. Recent structural reforms of the regulatory authority. In 2001 the National Board for Occupational Health and Safety and the regionally structured Labour Inspectorate merged to form a central Work Environment Authority. Since then, efforts have been made to standardise its approaches within ten regions in which some 500 staff cover the 5.3 million people engaged in work and related activities that are embraced in the Work Environment Act in the whole country.
http://www.eurofound.eu.int/working/2004/03/SE0403NU03.htni. Of course, this measure does not account for whether employers actually knew the extent of what was required from them by the statutory provisions.
324 Beyond Limits
In addition there are around 300 staff based at the Authority's head offices. As well as inspection activity the Work Environment Authority supplements and articulates the stipulations of the Work Environment Act and deals with transposition of EU legislation. To these ends it issues amendments and new working environment rules. The reorganisation of the Work Environment Authority was accompanied by an increase in the budget for the Labour Inspectorate and plans to return the number of its inspectors to that of the previous decade. The authority will also continue its strategic reorganisation towards a greater focus on organisational factors as much as technical ones, including systematic occupational health and safety management.
SETTING O E L S Procedures for setting OELs. OELs are derived from scientific data but are considered administrative limits since social, technical as well as economic aspects are all taken into account in setting them. Sweden had one of the first independent national systems for setting exposure limits in Western Europe. Its first list was published in 1969 and although it was based almost entirely on the ACGIH list of TLVs, subsequent Swedish lists have contained values that are substantially different from those of the American list. Indeed as Hanson (1998) shows the overall change in Swedish OELs since their inception in 1979 has been a steady trend towards lower values.444 The current system for setting OELs has its origins in procedures introduced in 1978 in which the then National Board for Occupational Health and Safety established two separate groups. The first of these was the Criteria Group based at the National Institute for Working Life (Kriteriegruppen fBr hygieniska grdnsvUrden Arbetslrvsinstitutet),"*5 composed of scientists whose task is to gather and evaluate the available scientific and medical information concerning substances that have been selected for its attention. A second group, known as the Regulations Group presents substances for its attention.
Hanson demonstrates that for example the change for substances overall between 1969 and 1994 corresponds to an average yearly reduction of 3.9 per cent. Most of this reduction took place in the first ten years. For carcinogens the reduction was considerably greater at 10 per cent and for solvents there was a 5 per cent reduction over the same period. This is despite the fact that Swedish OELs are not intended to be solely health based values but are set after taking into account issues of technical and economic feasibility. Originally based at the NIWL, most of the Group have subsequently moved to the IMM and the role of NIWL seems to have reduced.
Sweden 325 This group has a tripartite composition, with representatives chosen by trade unions and employers' organisations as well as members from the National Board (now part of the Work Environment Authority). Proposals for substances to be considered for OELs or for revision of existing OELs may come from the employees and employers represented by the members of the Group. Or they may be made by others such as occupational health professionals, the labour inspectorate or the secretariat for the Regulations group which is part of the WEA's Chemicals Unit. The Regulations Group drafts a priority list of such proposals for that is presentation to the Criteria Group The task of the Criteria Group is to provide the authority with the scientific criteria on the known toxicological and medical effects of the substance concerned. Published international research on the health effects of the substance in question in humans and animals is reviewed and its quality evaluated. Reviews also take account of similar critical evaluations undertaken by the Nordic Group of Experts on limit Value Documentation which is an international body set up by the Nordic Council446 to produce criteria documents for use in Nordic countries and the Dutch Expert Group which adopts a similar approach. The resulting criteria document44' from the Group contains the scientific data about the substance and if possible targets a critical effect and a dose-response/dose-effect relationship.448 The Criteria Group does not propose an OEL, rather, the criteria document provides the scientific basis for the evaluation undertaken by the Regulations Group in which issues of economic and technical feasibility are taken into account. Compliance with a proposed exposure limit is an important consideration and therefore the costs of compliance are a factor addressed in the proposal developed by the Regulations Group. A consequence evaluation is produced for each proposed limit value in which improvements in health are weighed against the costs of implementation. Technical as well as economic feasibility is taken into account and are summarised and reported to the Group to aid decision making. Data are collected from published reports, the labour inspectorate and prevention services as well as evidence from employers and trade unions in the industries potentially affected by a new or changed limit value, on the use of the substance, the volumes handled and the number of persons exposed. This The Nordic Countil was established in 1952 to promote co-operation among the parliaments and governments of Denmark, Iceland, Norway, Sweden and in 1955, Finland. These reports are published in the Arbete och ffiilsa series. The critical effect is the adverse effect that appears at the lowest exposure level (Nordberg et al 1988).
326 Beyond Limits evidence is an important part of the consequence evaluation produced by the Group (AIHA/CMA 1996). The deliberations of the Regulations Group result in recommended exposure limits which become the subject of formal consultation with trade unions, employers organisations and other bodies. The results of such consultation are taken into account by the Chemicals Unit of the Central Supervision Department of the Work Environment Authority and inform the final decision concerning the proposed limit value taken by the directorate of the National Board/Work Environment Authority. This results in a revised Ordinance on Limit Values, What Swedish limit values represent. The Swedish Work Environment Authority (Arbetsmiljoverket) is empowered under the Work Environment Ordinance (Arbetsmiljoforordmngen; SFS 1977: 1166) and Work Environment Act (Arbetsmiljolagen; SFS 1977: 1160) to issue instructions on the work environment without recourse to the legislature. The Ordinance on Limit Values (Hygieniska gransva'rden och dtgiirder mot luftfororeningar, Arbetarskyddsstyrelsens jorfattningssamling; AFS 2000: 3) is one such instruction that is revised approximately once every three years. All limit values in the Ordinance of Limit Values are binding. Some substances for example, styrene, crystalline silica, asbestos, cadmium and lead are more strictly regulated than others and subject to separate provisions since there is a demand for mandatory exposure measurement. An OEL gives the maximum acceptable average concentration of an air contaminant in respiratory air at workplaces. Concentration limits are usually averaged over eight hours ('maximal limit value', or nivagransvarde) and 15 minutes ('short-term limit', korttidsvdrde). There are ceiling values (takgransvarde) that are momentary limit values with reference times as short as five minutes. In the OEL lists, 'K' {Cancerframkallande, Grupp C), annotates carcinogenic substances, 'S' (Sensibiliserande, Grupp D), annotates sensitisers and 'R' (Reproduktionsstorande, Grupp E), indicates substances toxic to reproduction and ). H' ('Huden') annotates substances with the capability of skin penetration. The allergic potential is also considered when setting the limit value. In addition, the 'Hygienic limit values and measures for air pollutants' includes lists of substances, which are banned (Grupp A) or subject to license (Grupp B). Isocyanates, which are included on the OEL list, are also
Sweden 327
regulated by specific instructions on thermosetting plastics (HUrdplaster; AFS 1996:4).449 However, Swedish OELs are not intended to represent sharp dividing lines between healthy and unhealthy exposures. The recommendations that accompany the OEL ordinance state: 'It cannot be excluded that a few persons within a large group who are exposed to concentrations around or below the limit values can suffer mild and transitory discomfort. Nor can it be excluded that a still smaller number of persons in such a group may show symptoms of illness.' They go on to state that it is therefore important to seek to keep exposure to the lowest levels possible and that the OEL is not regarded as an end in itself but rather as an indication of what is definitely unacceptable. Therefore the employer is required to keep exposures to as far below the exposure limit as possible. According to this provision, theoretically, the Labour Inspectorate can enforce measures against an employer even if the limit is not exceeded.
ACHIEVING COMPLIANCE WITH O E L S The Work Environment Inspectorate450 within the WEA is responsible for enforcement of the exposure limits. It is an integrated part of the Authority and has access to all the scientific and technical support that can be provided through the WEA. The background outlined in the previous sections, provides an indication of the overall approach to regulating the achievement of better health and safety management and a clue to the likely role of OELs in this process. It shows that currently the emphasis in compliance strategies is with the achievement of systematic approaches to risk management by duty holders. Within this broad aim, there is a particular focus on certain issues for which improved outcomes are identified. Although not a priority issue
See European Agency website for an outline of this information on Swedish OEL: htrp://europe.osha.eu.int/good_practice/risks/ds/oe. The Work EnYironment Authority is currently refers to its inspectorate as 'inspection offices in ten localities*.
328 Beyond Limits in its own right, safety in working with chemicals is reflected in some of the current priority issues for the Work Environment Authority, For example, the industries that are the focus of the current Plan of Activity 2004-06 include construction and the timber industry. Hazardous substances are common in both. In the case of the timber industry the plan identifies wood-dust as a focus for inspection as well as surveillance of compliance with Work Environment Authority standards by suppliers. Since systematic management of the work environment is also a focus for attention across all the priority sectors and using OELs in risk assessment is a clear feature of Swedish regulatory requirements and one in which the labour inspectorate engagement is specifically identified, it might be anticipated that some consideration of OELs, especially in construction and the timber industry might feature in the inspection activities during the period covered by the current Plan of Activities. However, the Plan does not make any specific reference to such an intention (WEA 2004). In addition to this, as mentioned in the previous section, annual exposure measurements for certain hazardous substances including lead, cadmium, quartz, styrene, ethylene oxide, propylene oxide and synthetic inorganic crystalline fibres are stipulated by law and such measurements must be reported to the Work Environment Inspectorate. The regulatory requirements. Employers* duties of assessing risks and organising safe handling operations involving hazardous chemicals are specified in the Ordinances on Chemical Hazards in the Working Environment and on Occupational Exposure Limit Values and Measures against Air Contaminants 2000. Under these provisions, when assessing the chemical risks of the work environment, the hazardous chemical substances that occur or can be expected to occur in operations must be identified and assessment made of the risk of these substances causing ill-health or accidents. Documentation of risk assessment involving hazardous chemicals would normally be expected to contain the identity of the hazardous chemicals, note of their inherently dangerous properties and the exposure to which employees can be subjected as well as the handling risks entailed and the risk reduction measures decided upon. Guidance451 states: 'If there is a reason to suspect that the activity gives rise to air contaminants, the extent of the exposure must be investigated and account taken of its nature, level and duration. Thus, if a general risk assessment shows that air contamination may occur, these conditions need to be investigated more closely. Basic sampling See Chemicals Control at the Workplace - Limiting Chemical Hazards at Work, Work Environment Authority, Stockholm 2002 (in English).
Sweden 329 methods, for example by using detector tubes, may be acceptable means to confirm that the exposure is low. However, if the investigation shows cause to suspect that an occupational exposure limit is being exceeded, an exposure measurement must be carried out. This requires the person planning and carrying out the measurement to have the requisite knowledge to do so. It includes knowledge, concerning the choice of method and equipment, the timing and ability to identify the persons on whom the measurements should be carried out. The results of the measurements must be documented in a measurement report containing certain pre-specified data. Employees concerned must be informed of the results of the measurement and have access to the documentation.' (our italics) Regulation in practice. Compliance with these requirements however, is another matter. No specific data on compliance with limit values, of sufficient detail is available to evaluate the extent to which OELs actually feature in inspection practice. There are some statistics on actions by the Inspectorate in the occupational hygiene field that have been collected during the last five years. However these are not particularly helpful in determining how OELs are used in inspectorate interventions.452 The following observations are therefore based on what can be inferred from information on the inspection of health and safety management more generally combined with the views of inspectors and officials of the WEA and those of trade union representatives that we obtained in interviews that were undertaken as part of the fieldwork for this project. It is clear from the evaluations of the systematic health and safety management referred to previously, that this practice is far from universal. It is not possible to tell from these evaluations the extent to which employers carry out exposure measurements when assessing risks as part of systematic health and safety management, as they are required to do when exposures to chemicals with OELs are suspected. However it would seem unlikely that they would depart significantly from the generally limited compliance with systematic health and safety management that seems to be the norm. Moreover, according to officials of the Work Environment Authority, it is a problem to get many In addition there are occasional pieces of information relating to specific campaigns, such as during Health and Safety Week in 2003 when hazardous substances was the focus, the SWEA inspected 1800 workplaces in70 per cent of which it found cause to issue notifications concerning problems relating to chemicals and safety data sheets. Http://www.prevent.se/english/newslatter/ twooutafthreearenegligentwithhaza. asp. The same source reports a survey by the construction workers' union Byggettan in 2001 in which only one third of the 1,376 building workplaces surveyed had any form of risk assessment of hazardous substances been undertaken.
330 Beyond Limits employers to realise that OELs even exist. They suggest that employers are in fact measuring less than they have in the past. They attribute this decline, which they regard as quite marked over the last decade, at least in part to prohibitive costs of prevention services carrying out such measurement453 This observation was strongly endorsed by trade union sources, who argued that not only did prevention services not monitor any more because employers did not request them to, but that such services did not promote monitoring and did little to raise employers' awareness of its role.454 Trade union and other sources also claimed that preventive services have been employing fewer safety engineers and occupational hygienists. This was regarded as being brought about by the current orientation of prevention services towards responding to the occupational health needs perceived by the employers who were the market for their services. It was further argued that in articulating such needs both employers and often their workers too, were more interested in the role of occupational health services in relation to individual health concerns than they were in what was sometimes perceived as potential 'interference' by OHS in the (lack of) collective prevention strategies adopted by firms. It was further pointed out that it required an active union policy to deny members this perceived personal support in favour of prevention measures that were of a more collective nature, and as a consequence unions had become less involved than they were in previous times in deciding on which services were to be hired. Since employers themselves showed low awareness of the role of OELs in monitoring for compliance with health and safety standards for hazardous chemicals, it followed that there was limited market driven demand for occupational hygiene services. As the demand for these services has become less, there were increasingly fewer people employed by prevention services who could actually undertake monitoring properly. The trade unions also claimed that there has been a reduction in the provision of professional education and training to enable specialists to undertake monitoring. Such a cycle would inevitably contribute to fewer measurements As pointed out previously, prior to 1992 such services were heavily subsidised by the state (at around 30 per cent of their cost). Removal of subsidies coupled with the withdrawal of the employers' organisation from the national OHS service agreements from 1993 resulted in increased commercialism of the services influenced the extent to which they are used by smaller enterprises especially. Decline in the number of safety engineers employed by the services as well as an increased medical orientation further militates against their role in environmental measurement. They argued that such monitoring was only likely to occur if there was a trade union demand for it that was strong enough to oblige the employer to request such monitoring be undertaken by a prevention service.
Sweden 331 being undertaken. Trade union sources further suggested that greater expertise on monitoring was required within the inspectorate, commenting that while such expertise may have existed in the past, it was much less present amongst the current generation of inspectors. It is partly for these reasons that since its recent reorganisation, the Work Environment Authority has attempted to standardise practices in its ten districts. This has included trying to ensure that, while employers continue to be reminded of their obligations to undertake or to commission measurement as part of risk assessment, the Labour Inspectorate in each district is also technically competent and equipped to undertake them. Indeed, because of a perceived need for more rather than fewer measurements, currently labour inspectors are encouraged to carry them out in situations in which it appears unlikely that employers have the capacity to do so. Trade union interviewees argued that there was regional variation in the severity of the enforcement action that inspectors might take when they discover that workplace exposure levels exceeded OELs. However, the occurrence of such actions overall was so infrequent that it was not feasible to gather evidence to corroborate this claim. It was also agreed that there was variation between sectors in how much monitoring takes place. In larger workplaces in industries such plastics manufacture, motor vehicle manufacturing, in the paper industry and where certain substances are concerned, there is a tradition of monitoring. Generally larger enterprises in these sectors are the main users of monitoring, often having trained employees designated to carry it out. The problem is perceived to lie with smaller companies where there is little knowledge of the risks associated with the chemicals used and even less awareness of the meaning and use of occupational exposure limits. However, unlike in the UK and in Germany, there does not appear to have been a particularly prominent or documented development of strategy on chemical risk management with special reference to the recognised problems of addressing the subject in smaller enterprises and the role of OELs in this process. At the same time, awareness of the nature of the challenges involved appears to be widespread amongst the regulatory authorities and social partners.455
Indeed, the social partners have been involved in pprofducing joint guidance on the subject such as for example, the Chemical Guide, www.prevent.se/kemiguiden, an interactive web-tool, assisting especially small companies in finding out what is required from them and how can they go about fulfilling the requirements.
332 Beyond Limits Interestingly, both the Work Environment Authority and the trade unions commented on the significance of the role of regional safety representatives in increasing awareness of chemical risks in such workplaces and also in working in co-operation with the labour inspectors to identify and resolve problems. Although there is variation between industries and regions, generally regional health and safety representatives meet fairly regularly on an informal basis with labour inspectors to decide on strategies for dealing with risks such as those from handling and using chemicals in small enterprises. They are an important source of information for the inspectorate, since, as has been demonstrated in previous studies, they are far more numerous and visit workplaces considerably more frequently than the labour inspectors - especially the small and micro-enterprises (see Frick and Walters 1998 and Walters 2002).456 They therefore can and do alert the inspectors to the existence of problems as well as playing a significant role in resolving other problems without the need for the engagement of the inspectors. In practice employers tend to use the manufacturers and suppliers of chemicals as their major source of information and guidance on the safe use of chemicals. According to the legislation and regulations, suppliers are obliged to provide information about the risks of their products and how to use them safely - as in other countries they do so by providing material safety data sheets. The Swedish Chemical Inspectorate457 control the suppliers and it is emphasised by the authorities that the suppliers and manufacturers of chemicals should be consulted about safe use. However, unlike the experiences reported in the UK (see Chapter 4), there do not seem to be developed or documented regulatory strategies in which supply chain relationships feature significantly as levers to promote good practice amongst users of chemicals. Manufacturers* information can, in theory, be used by employers and trade union representatives to reduce risks of exposure to airborne chemical contaminants by supporting the choice of safer products. Since manufacturers and suppliers of new machinery also have information on the performance specifications of machines, including performance in relation to airborne contaminants resulting from their operation with regard to relevant OELs, this source is also important in decision-making during the purchase and installation of new machines. In addition, a risk assessment is required when new machinery is installed, thus providing an opportunity to measure performance and check against standards such as OELs. Both trade union officials and They are more numerous in terms of numbers of individuals, but since most RSRs are part-time there are still more full time equivalent inspectors (nearly 400 full time equivalent inspectors compared with320 full time equivalent RSRs). www.kemi.se.
Sweden 333 labour inspectors interviewed pointed to the possibility of these factors influencing decisions on the purchase of machinery. However, it was also pointed out that machinery itself is often manufactured outside Sweden and that low-emission machines may be difficult for users to find. Trade unions pointed to the role of well-informed and well trained health and safety representatives are enabled to participate in such decisions and to influence outcomes. However, neither unions not inspectors were able to provide evidence of the extent to which such practices might occur. Furthermore, trade union sources also pointed out that employers, especially those responsible for small enterprises that are struggling for survival often do not consult health and safety representatives, buy and install second-hand machines for which such information is lacking and moreover, do not undertake the required risk assessments on installation. Work Environment Authority strategies. Awareness of the problems of dealing with compliance across all the regions and sectors has prompted the development of current strategy within the Work Environment Authority. In terms of chemical risks and OELs it is concerned with what to measure and how and in what form to promote the education of competent persons within organisations to undertake measurement. It also clearly wishes to promote the education of employers themselves concerning chemical risks and the role of OELs and it supports the education of its own inspectors. It recogmses there is still considerable need to reduce variation in understanding and practice at the regional level. Part of the strategic approach therefore includes efforts to achieve consistency across the ten districts. As a result there are joint projects on measurement between the centre and the district levels of the inspectorate as well as efforts to co-ordinate sharing experiences across districts. For example in certain districts a considerable amount of measurement undertaken of exposure to wood-dust, while in other districts measurement is far less. Sharing experiences and expertise in this respect helps to promote better understanding of the nature of the problem of wood-dust exposure and helps improve the strategic approaches to achieving compliance. The Work Environment Authority would like to be able eventually to create an inventory of chemical usage in each region. It believes that it would then be possible to have a more systematic approach in the case of required measurement of exposure levels. It would also be able to match requirements for competence amongst employers, prevention services and the inspectorate, with needs for measurement in different sectors and regions. Wood-dust, As recent priorities for the Work Environment Authority have included hypersensitivity and current priorities include a focus on the timber industry, wood dust has been of some concern. The strategy of the inspectorate towards compliance with
334 Beyond Limits exposure standards for wood-dust therefore should provide an instructive example of the role of OELs in inspection practice. It was apparent from interviews with labour inspectors and WEA officials that achieving better control of wood-dust was perceived to be the focus for the inspectorate, not measurement and monitoring of exposure levels. In the Stockholm district for example, a strategic aim was for inspectors to visit all furniture makers. While there was a concentration of visits made by inspectors and a demand made for improvement, the use of OELs is not in the forefront of inspection activity. This is aimed more at encouraging employers to reduce wood-dust exposures at source. As in similar situations, described previously in the Netherlands, there is a perception that where serious problems of airborne dust occur, they are obvious and it is equally obvious when effective control measures have been introduced. Neither requires systematic monitoring to define their nature or effectiveness. Also the costs of such monitoring may be high and it is often argued that money would be better spent on solving or preventing a problem that can be largely identified by means other than monitoring. Enforcement, when it occurs, is therefore far more likely to be concerned with achieving such engineering control as improved exhaust ventilation than it is with measurement of OEL. There is also a strong emphasis on educating employers concerning risks in the use of products and processes that generate wood-dust. According to both trade union and Work Environment Authority sources, OELs for wood-dust therefore do not feature significantly in enforcement actions in the woodworking industry. They maybe quite important in setting specification standards for air quality to be achieved by new machines, in such cases manufacturers should therefore take them into account and they should feature in the specifications of such machines, in decisions concerning their purchase as well as in risk assessment during installation. How much this occurs in practice however is another matter. In many parts of the woodworking industry that are dominated by small enterprises struggling for economic survival, the same general problems as discussed above concerning the absence of attention to OELs in the purchase and installation of second hand machinery were known to apply to employers who are largely ignorant of the health effects of wood dust and the role of exposure limits.
Sweden 335
CONCLUSIONS The Swedish system for setting and using OELs has enjoyed a relatively long history of independent development in comparison with many of the other systems in the countries of the EU. It is also one in which OELs traditionally tend to be set lower than in other EU countries and in which there is a marked distinction between the processes for deriving the scientific basis for a limit and those for its economic/technical basis. Nevertheless, it is clear that it too, is not without problems of implementation and operation. For example, poor awareness of OELs amongst employers, especially in smaller enterprises, is of concern to the Work Environment Authority. Systematic health and safety management is the central strategic objective of the Work Environment Authority. It wishes to make OELs a more integrated part of risk assessment in this process. At the same time it recognises a general problem of awareness about the existence, role and use of OELs amongst employers that continues to thwart their more systematic use, A related issue is the reduction in capacity of prevention services to undertake measurement of OELs. This seems to be influenced by both the absence of a clear regulatory definition of what should constitute the technical resources and role of occupational health services (unlike for example in other Scandinavian countries such as Denmark, where they are more clearly prescribed) and the increased trend towards the commercialisation of such services. The combination of these two influences means that occupational health services are driven by market forces to provide the kind of service that employers want and are willing to pay for. Employers, especially in smaller enterprises are generally ignorant of the role and significance of OELs, therefore they frequently do not require monitoring from prevention services, preferring instead to concentrate their requirements more in areas such as medical surveillance.458 This in
Clearly there are exceptions to this, especially amongst large employers in industries where there has been regular and long-term use of hazardous chemicals such as for example in car manufacture, in some parts of the plastics industry and in paper and board. There are also exceptions in relation to specific substances for which there is a high level of public concern about risks associated with using the. Currently for example, substances such as styrene and isocyanates fall into this category and may be the subject of more intensive monitoring. However, in both such cases the role of trade union representatives in demanding monitoring appears to be quite
336 Beyond Limits turn has a long term effect on the capacity of such services to deliver more broad based preventive approaches including those associated with the detailed monitoring of OELs that should be part of risk evaluation and control for hazardous chemicals. These problems are further compounded by the general lack of access of small enterprises to prevention services. Countering these infrastructural weaknesses to some extent is the role played by organised labour in the regulation of work environment issues throughout the Swedish economy - and especially at the workplace level. Trade union health and safety representatives, whether representing employees of the same employer or operating regionally, include amongst their numbers many who are well trained and well informed.459 They exist in substantial numbers in comparison with either health and safety specialists of prevention services or labour inspectors. Chemical risks and the understanding and use of OELs feature in trade union training programmes on the work environment and in the information trades unions produce for their health and safety representatives, or to which they facilitate their access. For all these reasons it is likely that trained representatives have a significant role in promoting, monitoring and sustaining good practice in managing the risks of hazardous substances at work. The evidence of both work environment officials and trade unionists interviewed strongly supported the idea that the activities of trade union health and safety representatives within workplaces, either through their direct dealings with employers or through their relations with the labour inspectorate, formed a significant pressure instigating employers to monitor compliance with standards necessary for the management of the risks of hazardous substances. Moreover, since an important part of the regulatory provision for workers* rights to representation on health and safety includes the rights for trade unions to appoint regional health and safety representatives and for these representatives to have access to all workplaces where there are trade union members (between 80 to 85 per cent of Swedish employees belong to trade unions) this also may go some way towards offsetting the problems of understanding and use of information on chemical risks (including on the role of OELs) in small enterprises.
significant and they suggest that without such pressures both employers and prevention services would probably do less rather than more monitoring. This is especially so in the case of senior health and safety representatives and for many regional health and safety representatives.
Sweden 337 A further issue relates to the meaning of the OEL. Although the legislation and the official guidance is clear that OELs adopted within the Swedish system are not solely health based, nor therefore 'safe levels', according to the officials of the Work Environment Authority, labour inspectors have in the past had no formal power to demand further reduction in exposure levels if the employer is able to demonstrate that measurements shows exposure to be already below the OEL. There is some interesting case law here which suggests that employers have been able to defend the position that they have done all that is legally necessary of them if they are able to demonstrate that they are working within limits defined by the OEL - even when the labour inspector believes it would be technically and economically feasible for them to reduce exposures to much lower levels.460 Clearly such success conflicts with the theoretical position and official guidance on the meaning of OELs and sends ambivalent messages concerning their use. This is especially so since Swedish OELs are based on comprehensive and elaborate summaries of the toxicological literature. Division of the standard setting process into two distinct parts - one scientific and one regulative, aids distinction between the health and technical/economic grounds for setting them. The limits themselves are on average lower and therefore more protective than in other countries. Nevertheless as Hanson (1998; 98-102) has demonstrated, despite these positive aspects of the Swedish system, the regulatory ratios461 for many substances are too high for the exposure limit to protect It was suggested dining interviews with officials of the Work Environment Authority that in future the approach to persuading employers to reduce exposures to as low as is technically feasible below the exposure limit would be to use a combination of legal requirements drawn in part from those on exposure limits but also from other ordinances on more general measures to limit air pollution. However the introductory paragraphs to the OEL list make it clear that air in the work environment should not be unhealthy and in any case not more polluted than indicated by the standards provided in the OEL list. In a case in 1996 (1996-12- 05), the National Board acted to repeal a notice from a labour inspector to a firm (Setrab), to reduce exposure to gases at their workplace to levels well below the OEL, because of evidence of medically documented health problems at the OEL, arguing that the companies should be given a level playing field for OELs and therefore it was not acceptable to order some companies to reduce them further than others when there were alternative strategies (such as personal protection) that could be used. (Source; Frick, K. National Institute for Working Life (NIWL), personal communication). A term that Hanson (1998) uses in his discussion of the limitations of OELs as indicators of safe levels of exposure. It refers to the quotient between the OEL and the reference level (i.e. the lowest concentration at which adverse affects appear or the highest at which no adverse affects are yet
338 Beyond Limits against the critical effect of the hazardous substance and the limits are therefore not standards that will protect all workers adequately against hazardous substances. So what is the role of OELs in practice in Sweden? Although the statutory provisions on monitoring are quite clear, it is recognised that there are problems with achieving good compliance with them. These are partly cultural and partly resource based, and there appears to be a link between them. At the same time it is not apparent to what extent or how strictly the labour inspectorate has enforced such requirements in the past or indeed is likely to do so in the future.'162 Most interviewees, having identified the various weaknesses in the system that we have discussed here, nevertheless felt that the OEL has an important role. A loose synthesis of their views indicates four possible reasons for valuing the existence of OELs: -
They provide a standard for monitoring exposure to hazardous substances and therefore can be indicators of compliance with requirements for the systematic occupational health and safety management of hazardous substances. Their role in this respect may not be pursued rigorously everywhere, but its existence is nonetheless important. It is useful in situations in which employers have the resources to undertake such activity and may also be a useful tool for regulatory authorities and practitioners who are seeking improvements at the 'dirty end' of industrial activities. Compliance with such standards therefore remains a useful indicator of good practice even though not in ubiquitous use.
-
They provide an important informative and educative role in raising awareness on chemical risks. Even though there is considerable ignorance of their detailed meaning (and in some cases of their very existence) they are nevertheless an important reference point and objective standard for informing discourse on prevention strategies.
-
They act as a norm, especially for larger employers. These (usually) comply voluntarily with OELs and other ordinances, but they nevertheless like to be
observed). Thus, for example if an OEL of 10 ppm is based on the observation of the presence or absence of a health effect at lOOppm then the regulatory ratio would be 0.1. We were unable to obtain any detailed records of enforcement actions or to compare their frequency or seriousness with enforcement actions on other aspects of health and safety at work. However, interviews with both the Work Environment Authority and the trade unions suggested that such enforcement was relatively limited.
Sweden 339 told by authorities, such as the Work Environment Authority, what is right and what is wrong, and thereby also to have 'a level playing field'. -
While monitoring airborne exposures may prove difficult, OELs are an important feature of suppliers' information about the use of hazardous chemicals. They are important in determining specification standards, in the approach to risk assessment and in alerting employers, workers and their representatives to the need to take seriously risk management issues involved in processes concerning the use or substitution of such substances. They apply not only in the case of use and handling of hazardous substances themselves but are also helpful in determining risk management issues concerning the purchase and installation of new plant.
— They may have other important uses such as in claims for compensation resulting from work-related mortality and morbidity. The problems with many of these uses of course, return us to debates concerning the scientific uncertainties on the levels of protection afforded to workers by OELs, the degree of clarity with which their meaning and their limitations are presented and understood and the extent to which substances with OELs are representative of the full range of substances and the risks associated with their use at the workplace. These are issues that we will take up in our concluding chapter.
This Page is Intentionally Left Blank
341
10
BEYOND LIMITS? — THE PLACE OF O E L S IN THE NEW REGULATION OF CHEMICAL RISKS IN EUROPE
INTRODUCTION In this final chapter we draw together the various threads of our investigation on current procedures for setting and using OELs in EU Member States and the methods and practices for achieving compliance with them. We set our findings in a wider discussion of the role of OELs in the regulation of occupational health and safety management more generally and we attempt to determine the continued relevance of OELs to present day strategies to achieve improved chemical risk management across all European workplaces. Since it is fundamental to the analysis of any strategic position on OELs, we begin by asking once again, what are OELs for? We continue with an exploration of their role in regulatory approaches to risk management drawing mainly on the conclusions of our country studies. We consider the significance of the regulatory framework and the role of inspection as well as the infrastructural support for monitoring exposure to chemical hazards and we identify some of the limitations of both past and present systems. We conclude by noting some of the considerable parallels in national systems and indicate the lessons suggested by these experiences in common. The two linked and key questions around which our discussion revolves concern: -
What drives informed and competent risk management in chemical safety?
342 Beyond Limits -
What is the role (if any) of OELs in this process?
There are a number of pragmatic but none the less important reasons that appear to be informing regulatory inspectorates and their equivalents in their development of strategies to regulate risk management of hazardous chemicals. They are set within wider strategic approaches to regulating workplace risk management generally and cannot be fully understood in isolation from this context. They to revolve around what is regarded as possible and practicable in terms of preventive approaches for managing risks chemical risks that might be undertaken by duty holders who are limited in their willingness and capacity to either understand or use the sophisticated notions of measurement of performance implied by a professional conception of OELs. They may also reflect the recognition of the limited resources available for the regulatory agencies to intervene in ways that would extend the use of OELs as performance standards. These 'pragmatic' prevention strategies have often been arrived at in agreement with trade unions and employers associations in the sectors they concern and thus their pragmatism is one shared by both representatives of employers and workers. There is quite clearly a theoretical role for OELs as indices against which the measurement of hazardous substances may be undertaken in risk assessment and systematic management of health and safety. However, based on our findings in all of the countries we examined, we question the extent of the reality of this role in practice. The pragmatic and practical issues confronting inspectorates that monitor compliance with regulatory strategies to improve risk management of hazardous substances we think are in part responsible for the development of the new orientations to regulation observed in some of the countries in our study. These new orientations have major significance for the continued role of OELs. As we commented in Chapter 2, there are other, wider reasons for these changes that need to be taken into account. Moreover, although there are developments at EU level that can be related to the same changes, such as the so-called REACH proposals, those within the member states we have studied are not a harmonised response to supra-national requirements. We discuss the significance of these issues in the concluding section of this chapter, noting their impact on the role of OELs. We suggest that while it is not certain how OELs will be used at the workplace level in the future, it is quite clear that such use will remain bounded by issues of understanding and resource availability. Strategies to order the management of chemical risks by legislative, economic, social and regulatory drivers will need to address this adequately in their operation in practice.
Conclusions: Beyond Limits
343
WHAT ARE O E L S FOR? Legislation on health and safety in the use of chemical substances in all EU countries is usually in the form of some kind of framework provision supplemented by more specific requirements. Provisions emphasise process-based approaches to the management of risk to a greater or lesser extent in all national systems. National organisations for securing and monitoring compliance with these legal requirements are also present in all countries. They usually operate under the authority of a central Government Department or Ministry and mostly have some form of overall responsibility in both the setting and enforcement of OELs. There are differences between countries, for example, in the extent to which national authorities are regionalised, deal exclusively with health and safety, have specialised resources for chemical safety and are sole enforcing authorities. In the countries in our study two particular exceptional situations can be mentioned and both have implications for the way that health and safety management of hazardous substances is regulated in those countries. One is the dual German model where social insurance associations also have rule making and enforcement authority in addition to that of the state inspectorate. The other is in Italy, where although the Labour Inspectorate have a national responsibility for health and safety under the Ministry of Labour, in practice the task of seeking compliance remains with regional and local structures of the public health system, under the Ministry of Health.463 Within national regulatory systems there are strong similarities between the various structures and processes for setting and achieving compliance with OELs in the EU. Similarities are also evident in the role of national research institutes for health and safety, which play a strong, independent, advisory role in the setting and adoption of OELs in most countries.464 A further similarity is in the way in which national structures for setting or adopting OELs allow for considerable stakeholder participation. However, these similarities do not entirely override national differences apparent in the setting, status and use of OELs as well as in their legal context. There are also broadly comparable scientific/occupational hygiene treatments of the limits themselves in terms
Arguably this has contributed to a strong focus on technical standards in Germany, while in Italy the absence of substantial leadership from any central national authority has contributed to considerable regional diversity in regulatory practices in relation to chemical hazards. The UK. is somewhat exceptional in the EU in that it does not have a national research institute for health and safety comparable with those found in most other EU states.
344 Beyond Limits of the use of time weighted averages, short-term exposure limits, ceiling values and annotations for special risks such as carcinogenicity, skin absorption, allergenic substances etc. But although there is widespread use of similar terminology, there are differences in the detail of the way in which it is used in relation to different substances in different countries. There are also differences in the degree of sophistication and support for national systems and the extent to which they are capable of undertaking their appointed tasks. Generally those systems that have been in place longest, such as the UK, Dutch, German and Nordic ones, would appear considerably more robust than those of more recent origin, especially those of Southern European countries. Perhaps the most significant difference that is relevant to our interests is found in the German system, where the technical orientation and the extensive provision for surveillance through both the state inspection system and that of the BGen means that there has been considerably more monitoring of exposures in relation to OELs by these organisations than we were able to document in any of the other countries in the study. The problems of understanding and use identified by previous research on the UK situation are largely borne out by experience in other EU countries. In the legislation and official guidance of most countries it is made clear that OELs are not solely health based, nor therefore 'safe levels'. Division of the standard setting process into two distinct parts - one scientific and one regulative, aids distinction between the health and technical/economic grounds for setting them. The general principle is that exposure should be as low as is possible and OELs, whether legally binding or otherwise are indicative of what should be achieved but not necessarily all that should be achieved. Nevertheless, tendencies to regard them as 'safe levels' are persistent and are expressed to varying degrees by both employers' and workers' organisations. In all countries it is recognised that small company owner managers generally have limited awareness and understanding of the meaning of OELs and therefore little capacity to apply them adequately in their risk management strategies. Their capacity to do so is also severely constrained by their limited access to support from the expertise of prevention services. This situation begs the question 'What are OELs for?' From our review of both the structures and processes for setting OELs in the EU and their use in the countries we have studied in more detail, it would seem that the answer is that they have a variety of functions: -
They are used as reference tools for monitoring systematic management of chemical risks in larger organisations where there is experience and support for such a task either within the organisation or through the use of technical assistance from external prevention services/occupational hygiene consultants.
Conclusions: Beyond Limits
345
Clearly this is important in sectors of industry where dangerous chemicals are in use, where substitution is not possible and specification standards for machinery and processes do not mitigate the need for monitoring performance standards. Their use in these situations may have some benchmarking value for other workplaces, however, strong evidence of widespread transfer of good practice is hard to find. Their use as reference tools in monitoring workplace exposures in such firms is also a useful indicator of adequate risk assessment for regulatory agencies in enforcement practices in firms in which hazardous chemicals are in use and where it is suspected that exposure levels are high. Their role may not be pursued rigorously everywhere, but its existence is nonetheless important and particularly useful in seeking improvements at the 'dirty end' of industrial activities. Compliance with standards for which OELs are a reference point remains a useful indicator of good practice. They are also useful reference tools, from a scientific/technical perspective, for large scale surveillance of exposure such as has been practiced in relation to various substances in Germany, and which has helped to contribute to understanding concerning the health effects of exposures and the consequent need to reduce them. They provide an important informative and educative role in raising awareness on chemical risks. Even though there is considerable ignorance of their detailed meaning (and in some cases of their very existence) they are nevertheless a reference point and objective standard for informing discourse on prevention strategies. They may also be useful norms for larger employers to follow. While monitoring airborne exposures may prove difficult, the existence of OELs is an important pressure on suppliers to provide information about the safe use of hazardous chemical products that acknowledges and makes use of their OELs. As such they have a role in several different loci in risk assessment cycles. Moreover, they are important in determining the approach to risk assessment and in alerting employers, workers and their representatives to the need to take seriously risk management issues involved in processes concerning the use or substitution of such substances. A caveat concerning their use however concerns the need for a proper understanding of their meaning. That is, for example, if the notion that they represent safe levels, or even values above or below which dramatically different effects occur are persistent they undermine the value of OELs and contribute to their misuse.
346 Beyond Limits -
Provided the caveat concerning proper understanding of their meaning applies, they may have a helpful role in defining specification standards that can be used in determining risk management issues concerning the purchase and installation of new plant. In some situations where monitoring is anyway extremely unlikely, such specification standards may obviate the need for its use.
While these are all positive uses, they also need to be seen in the context of the enormous levels of ignorance about OELs amongst users of chemical products. British research has demonstrated this quantitatively (HSE 1997). We were not able to match these quantitative estimates of ignorance amongst employers with similar quantitative studies in other countries, but nevertheless there was a strong consensus in the literature and amongst interviewees that the same situation prevailed. This of course leads us to question the extent to which the above ideal scenarios of OEL usage actually occur in practice. It also helps to explain the strong orientation amongst prevention specialists, trade unions and regulators towards the use of substitution, specification standards and technological development as means of dealing with chemical risks. And as we have already noted in the introduction to this chapter, it partly explains the preference of modern regulators in some countries for a move away from a central role for OELs in monitoring compliance. It should also be mentioned that OELs are sometimes subject to uses for which they are less appropriate and for which there seems to be no scientific or ethical justification. Aside from frequent abuses arising from ignorance or misunderstanding of their meaning, further examples of misuse include their involvement in determining situations in which additional bonus payments for unhealthy working conditions have been negotiated such as in Greece, and their somewhat dubious role in cases involving compensation claims for work-related mortality and morbidity, as well as their use in redundancy settlements as in the case of previous work with asbestos in Italy. Additional to these uses and abuses, is the situation in which the adoption of EU systems for setting and using OELs is perceived to be at odds with a country's traditional approach to regulating the management of chemical risks and which therefore gives rise to a level of concern about the meaning and role of OELs as legal standards. Thus, interviewees in Italy articulated a worry that national adoption of EU 'pragmatic' standards that take economic considerations into account will undermine the Italian workers' constitutional right to healthy and safe workplaces. According to this argument the assumption of a level of risk that is implicit in such standards is fundamentally at odds with workers' rights to health that are enshrined in the
Conclusions: Beyond Limits 7A1 347
constitution. Italy was the only country in which this specific concern was expressed and arguably this is because it is the only one in the study where such rights are constitutionally defined. It is therefore a constitutional problem that may not have widespread application outside Italy. And in Italy itself, its significance is moderated by the considerable variation in regional practices and infrastructural support for health and safety. However, it is nevertheless indicative of the important changes in meaning that occur when OELs become part of the regulatory system. It is also related to other perceptions of the problem of the meaning of OELs, that are evident in all countries. Comments received from regulatory inspectors in countries such as Italy and Greece, but also in northern European countries such as Sweden and the Netherlands, suggest a concern that giving OELs a form of regulatory status created both the potential for misinterpretation and at the same time placed equally unwanted limitations to inspectors' discretion. In such circumstances the existence of an OEL is sometimes viewed as an unhelpful distraction from the main business of improving the work environment. As a consequence it is marginalised in the regulatory inspectors' armoury of inspection tools for reducing exposures to as low as is technically possible. We saw hi the case of the UK that such concerns are amongst those responsible for causing regulators to reappraise the position of OELs in regulatory strategies and that developments in recent years such as the focus on control banding and using simplified methods of chemical risk assessment have been a pragmatic acknowledgement of the failure of the central focus that was given to OELs in the control strategies of the 1980s andl990s. They are also behind the more recent move in UK provisions to both simplify the framework for OELs and to ensure that compliance with an exposure limit is not regarded as an alternative to applying good practice and reducing exposure as low as is reasonably practicable. As we discuss further in the following section, similar conclusions have been reached in other counties.
THE CHANGING ROLE OF O E L S IN REGULATORY APPROACHES TO ACHIEVING CHEMICAL RISK MANAGEMENT The regulatory framework. The predominant pattern in the countries of the EU is for an OEL to have some legal definition within the application of more generic health and safety legislation. Thus, in most countries authorities report that there are a number of OELs that are legally binding limits. In a few cases these appear to be restricted to those that are in force as a result of compliance with EU Directives but in many cases the list is longer. We have not looked at the full lists of exposure limits for each country in
348 Beyond Limits depth, but we have noted from the available literature that while broadly comparable, there are differences in detail, both with regard to the number of substances included and in some of the values set. However, we also note that the significance of such differences as an influence on practice is uncertain. They do not, for example, appear to have had any material bearing on the extent of measurement or its enforcement in the countries studies. Nor do they appear to be the cause of any differences in strategies on the part of the regulatory agencies to improve compliance. In all of the countries in the study post-Framework Directive moves towards process regulation of OHS management dominated the approach to regulation by the regulatory agencies. Thus, their regulatory strategies were focused on the means of securing compliance with a systematic approach to health and safety management rather than with breaches of individual provisions. As we have already indicated, OELs could play a role in such strategies as reference points against which compliance with systematic approaches to risk management for hazardous chemicals might be monitored. Such an approach may have occurred in some cases as is evidenced in Sweden, where regulatory authorities pointed out that measurements were made or checked by inspectors where it was suspected that OELs were in danger of being exceeded and in Greece and other countries where there was evidence of occasional enforcement actions in which proof of compliance with OELs was mandated. However such instances were exceptional. Far more significant in the strategies of the regulatory inspectors was the notion of a holistic approach to OHS management. This took a variety of forms in which arrangements for chemical hazards might be included. For example, in Greece considerable regulatory attention appears to be focused on trying to establish whether firms had made contractual arrangements to use prevention services or individual prevention specialists. In the Netherlands and Sweden where such arrangements were also important (and considerably better developed), chemical hazards were frequently subsumed into broader reviews of risk management especially in small to medium sized enterprises. Dealing with chemical risks in these contexts involves a complete cycle of risk management approaches ranging from the availability of suppliers' hazard data information, through specification standards for machinery and processes to the possible requirement of evidence of performance standards in relation to OELs in the auditing of effectiveness of risk management measures. In practice however, the latter seem to be seldom invoked and not infrequently, simpler indicators of performance were sought.465
465
Such as for example visible evidence of the presence of wood dust, or simplified occupational hygiene measurements, as in the Netherlands (see Chapter 8).
Conclusions: Beyond Limits
349
In the UK the revisions to the OEL Framework that come into force in 2005 were undertaken in the light of the limited application and understanding of relevant requirements in the previous versions of the COSHH regulations, especially in small and medium sized firms. As we demonstrate in Chapter 4, they are part of a strategic approach to regulating chemical risk management in which an essentially pragmatic recognition is afforded to the need for simple, workable solutions that employers in these kinds of organisations are thought likely to have both the will and capacity to implement effectively. At the same time the architects of the reforms claim there are sufficient safeguards in their approach to ensure the adoption of principles of risk management that are appropriate according to the risks posed by the particular chemical substances in question. Nevertheless, as we also saw in Chapter 4, critics have argued that the approach is a capitulation in the face of insufficient resources in the health and safety system to achieve anything more meaningful. Also strongly in evidence in some countries such as the Netherlands and Italy for example is the considerable attention regulatory agencies pay to gaining sectoral or regional/sectoral level agreement between representative bodies of employers and workers for OHS management improvements in particular industries. Typical of these initiatives are the sectorally based 'covenants' in the Netherlands in which specification standards on emissions for machinery and substitution principles for chemicals may be introduced. On a smaller scale, in Italy as well as in other countries, such 'partnership' approaches involve inspectors in negotiations on health and safety management with representatives of employers and workers at local/sectoral levels where the local density of small firms involved in similar activities make an agreement concerning the health and safety aspects of particular processes (including chemical hazards) especially viable. Again, in these situations the technicalities of monitoring and OELs are likely to be substituted by specification standards and simpler measures of performance. A linked approach also much in evidence in Germany, Sweden and the Netherlands is the policy of regulatory agencies to focus on 'projects' in health and safety issues, which might concern specific processes, machinery, industries, or health effects such as sensitization, or localities, or combinations of these. Again, chemical hazards, such as those arising from wood-dust or solvents are sometimes the focus of such projects. They generally involve a concentration of regulatory effort on particular sectors and processes, that is intended to result in not only improved OHS management practices in the workplaces that are the recipients of such attention but also, a cascading effect to other workplaces, aided by the publicity for the project, peer group pressure within the sector/locality and the involvement of representatives of employers and workers in the sectors concerned. Although these approaches were much in evidence in the countries
350 Beyond Limits mentioned and interviewees were able to point to local evidence of their success, the success of the desired cascade effects was less clear. An overall approach to regulating chemical risks through using indicators of good practice and safe plant that could be reasonably assumed to indicate low risk of excessive exposure to hazardous chemicals and thus reduce the need for monitoring seems to be most systematically developed in Germany. However, similar approaches were also in evidence in Sweden and the Netherlands. It was only in Germany that we found evidence of a more systematic and large-scale approach in which OELs clearly featured in the regulatory framework and were transferred to workplace surveillance in a systematic manner. As the example of the so-called 'negative list' in relation to the 2 mg/m3 OEL for wood-dust shows, there is an attempt to link requirements to achieve improved exposure levels with evidence of current levels of exposure and arrangements for measuring them. However, interviewees expressed skepticism about the widespread use of such measurements, especially in the small and medium sized firms for which, neither the state labour inspectorates, nor the inspectors of the BG had the resources to achieve significant access. There was also sometimes concern that the role of the different agencies with regulatory powers was potentially competitive rather than collaborative and might result in unnecessary duplication of effort and thereby a wastage of precious resource. In summary then, the regulatory framework for managing chemical risks in the workplace that is developing in EU 15 member states has in common an orientation towards process regulation in which the impact of the principles behind such wider EU measures as the Framework Directive 89/391 is evident.466 Amongst the more legislatively advanced northern European member states these principles co-exist with specific strategies for achieving improved chemical risk management either through generic approaches towards control banding such as in the UK or through the related approach to specifying process standards such as operated in Germany. Linked to such approaches are precautionary principles that emphasise controlling risks at source, substitution and even the removal of extremely hazardous substances altogether from the market. There is widespread recognition that all these approaches require the engagement of employers, workers and their representatives in bringing about their effective implementation. Various methods are supported by the regulatory agencies to However it is important to acknowledge cause and effect here too since existing legislative approaches in some member states themselves had a strong influence on the thinking behind the formulation of the principles implemented in the Directive (see Walters (ed) 2002 for a detailed discussion of this point).
Conclusions: Beyond Limits
351
achieve this including sectoral level engagement, special projects, partnership arrangements and supply chain strategies. In all cases in the advanced market economies of northern Europe there appears to be a general acknowledgement that focusing on OELs is somewhat tangential to these ends and that while the institutions and processes for setting exposure limits remain part of the infrastructure of health and safety regulation at national level in most countries, expectations concerning their role in risk assessment and its regulation at the workplace level are quite limited. The notions that lie behind these developing national level regulatory frameworks are also relevant to the thinking at European level that has informed REACH. There are for example similar concerns about getting better knowledge of chemical risks and improved risk management disseminated to users in all of the situations in which chemicals are found in the workplace, and not just to large workplaces in the chemicals industry. The regulatory approach to achieving this under REACH is likely to involve suppliers' responsibilities to provide information that are both more onerous and more comprehensive than is currently the case. It will further involve an obligation on users to ensure that the use to which they intend to put a chemical substance is that covered by the suppliers' information. If it is not, users may be obliged to communicate the nature of the proposed use to the supplier in order that best advice can be given. Thus a two-way communication within the supply chain is envisaged. It is unclear what will be the role for the measurement of exposure in relation to exposure limits in this process. In the studies that have been undertaken in relation to the future implementation of the REACH principles, approaches based on control banding and specification standards in achieving a targeted approach to risk assessment outlined above seem to be favoured.41" While there is some limited support in the literature for the notion that such strategies result in standards of protection that are equivalent to those achieved by monitoring to ensure exposure limits are not exceeded, most of such evidence has been gathered from willing participants in trials to test the scientific validity of the approach. It is therefore not clear how widespread would be their adoption in situations for which inspection and regulatory scrutiny is difficult It also needs to be borne in mind that two-way communication within the supply chain presupposes the, as yet, untested existence of a variety of supports and levers to facilitate and encourage users to engage in such activity. As we pointed out in Chapter 2, present day supply networks exist for a variety of business reasons, many of which are to off-load responsibilities for care that are seen as not profitable. It is therefore far from clear that the same supply networks will automatically lend themselves to be conduits for improving health and safety practices
See for example ECETOC (2005).
352 Beyond Limits of either suppliers, users or their intermediaries without considerable additional pressures to do so. In some cases they may actually militate against such uses. The role of regulation. Breach of requirements relating to binding values is either a criminal or administrative offence (or both) depending on the national regulatory system and the seriousness of the breach. Penalties are most commonly fines, the levels of which are defined usually in the relevant legislation. The extent of the use of such penalties is difficult to determine from existing records. However, interviews with subjects in all countries suggest that, as in the UK, (where some limited empirical study has been undertaken) compliance (or otherwise) with OELs is not a major subject for enforcement action - nor indeed is it even a significant aspect of regulatory actions that involve hazardous chemicals. There seem to be several linked reasons for this, most of which relate to the limited resources of both inspectors and inspected as well as to a perception that there are frequently other, more appropriate means of achieving improved risk management of chemical hazards, such as we have already described. Thus, inspectors often question the relevance of focusing on monitoring OELs in chemical risk management. At the same time they frequently do not have the capacity to do more than demand evidence of measurement, they are neither equipped nor skilled sufficiently to be able to undertake such measurement themselves. Although in most countries, such skills and equipment are possessed by at some level within regulatory inspectorates it is usually as specialist services to which ordinary inspectors may have limited access. In some cases such as in Sweden for example (and also possibly in the Netherlands and in Greece) an effort is being made to distribute such resources more evenly across inspectorates so all regions/sectors can have improved access to them. Furthermore, it is widely understood to be the responsibility of duty-holders to undertake measurement. As we have repeatedly seen, this may be reasonably well acted-upon in large companies that use hazardous chemicals, but such responsibilities are far more seldom exercised by the owner managers of the small enterprises that are also substantial users of hazardous chemicals. Moreover, the training and experience of inspectors themselves is not always adequate to ensue they are all confident in handling the scientific/technical issues involved in the interpretation of monitoring data in relation to OELs. A further factor in the relatively low profile of enforcement actions in relation to OELs in some countries may be the previously mentioned involvement of the regulatory agencies in various means of securing compliance through exemplary projects and especially through voluntary agreements such as the covenants found in a number of sectors in the Netherlands. While by no means limited to issues of chemical risk, these
Conclusions: Beyond Limits
353
initiatives often include chemical risk management as part of their remit and therefore are of some influence on regulatory strategies on hazardous chemicals. There are two aspects that are possibly significant in relation to enforcement. One concerns the extent to which these efforts can be regarded as forms of 'reflexive regulation' in the sense that they represent efforts on the part of the regulatory agencies to encourage forms of self-regulation by agreement between employers and trade unions (and sometimes others such as suppliers or local authorities). This kind of 'regulation of self-regulation'468 often implies a changed approach to enforcement activity.469 Participating organizations, agree to meet particular specifications and to aim for performance targets agreed between themselves, the regulatory authorities and the representatives of their workers, and are spared a degree of external inspection of the minutiae of their activities since they are monitoring their own performance. The nature of such enforcement action that may occur in these situations is more likely to relate to failures in meeting generic systematic OHS management standards than it is to failures in relation to individual requirements such as monitoring of hazardous substances. The second aspect relates to the desire of regulatory agencies to make overall progress in improving health and safety outcomes through cascading the project approach. Interviewees from regulatory agencies in countries such as Italy spoke of the need for greater attention to an advisory role for inspectors in such initiatives and stressed the importance of their educational functions in approaches to improving health and safety through partnership and a focus on a more holistic approach. Again these might result in less obvious enforcement actions in relation to hazardous substances in projects, with the aim that good practice that is achieved with the help of education and advice from inspectors will be passed on to other firms. Of course, it is probably also the case that enforcement actions in which issues of chemical risk management are addressed, including those in which OELs may be implicated, are recorded in ways in which these aspects are not prominent. The emphasis that regulatory agency inspectors and officials that were interviewed placed on 'holistic' approaches to ensuring compliance with systematic risk management, coupled with the difficulties in interpreting recorded enforcement data mean that a considerably more detailed study of inspection practices in process regulation is required before it is possible to make a definitive statement concerning the true extent of enforcement actions in which OELs are involved in the countries studies. However, the See Chapter 2 for an explanation of this term. Indeed, critics argue it implies reduced enforcement activity.
354 Beyond Limits strong impression gained from the interviews is that they are certainly no more significant than has been already demonstrated in the UK (HSC 2002). Who monitors workplace air? While measurement of airborne pollution to assess risks and monitor risk management is the responsibility of employers, in practice it is often undertaken by external expertise. Regulatory inspectorates, (perhaps with the exception of those of the dual system in Germany), rarely engage in proactive acts of monitoring themselves, instead it is undertaken by prevention services and/or a variety of other consultants. A major difference between the UK and most other continental European countries is in the nature of the legislative provisions that oblige employers to use prevention services to support their management of OHS, and the further provisions that serve to define the competence of the services found in these countries - in contrast to the rather limited legislative requirements concerning competence that characterise the British approach. Although there is considerable variation in the detail of these requirements, they exist in most continental EU countries and many have been there for some considerable time. All have played a substantial role in national arrangements to implement the Framework Directive and, in particular, to provide support for risk assessment/management. Not surprisingly therefore, in most countries in our study such services are perceived as having a front-line role in monitoring workplace airborne exposures to hazardous substances. In some countries an additional significant role is also played by a variety of other consultants. In our country studies we were able to identify several problems with this (theoretical) position, which may contribute to undermine its effectiveness.
There is variation in quality and competence of external prevention services/consultants. Although countries such as the Netherlands have certification systems in place that are designed to maintain high standards of competence from prevention services, the effect this has on their capacity to undertake occupational hygiene is not clear. While employers are obliged to contract with an Arbadienst to ensure that the risks of their enterprises are evaluated appropriately and risk evaluation is a statutory requirement for the services that the Arbodiensten supply to support employers, the degree to which such evaluation actually carried out appears to be less than optimal (Karageorgiou et al 2000:277-283). They are commercial organisations and the main market demand for their engagement is directed towards sickness absence and medical surveillance. Therefore it is likely that unless employers demand it, they will not undertake monitoring of workplace air. For the same reasons it is likely that, despite requirements on competence, many of the Arbodiensten may not posses the expertise required for sophisticated monitoring of OELs. Similar concerns were expressed in Sweden where it
Conclusions: Beyond Limits
355
was suggested that, in fact, as in the Netherlands, the frequency of measurement undertaken by occupational health services had declined over the last decade. In Italy there has been considerable debate surrounding provisions (or more correctly, the absence of provisions) to ensure quality of prevention services that are a product of the Law 626 (implementing the Framework Directive 89/391). In November 2001, the European Court of Justice upheld a complaint that Italian legislation did not make the use of external prevention services compulsory where skills within undertakings were insufficient for risk assessment (ECJ Case C49/00 Commission v Italy, 15.11.01). Since then, what should constitute quality in external prevention services has been the subject of on going discussion but it is unclear what, if any, will be the legislative outcome of such discussion or what effect, if any it will have on the capacity of such services to undertake airborne monitoring.
In Greece although much is expected of their role, external prevention services for OHS are a recent development. It is assumed that trained safety engineers and occupational physicians (constituting the specialist personnel of the EXYPP and ESYPP) will: -
reduce the deficit in knowledge in relation to securing improved management of chemical risks within systematic OHS management the extent of exposure future situations that require monitoring.
The EXYPP may provide the technical support to employers to enable them to understand the role of OELs as well as undertake monitoring for them. Increasing demand for their services will increase the need for people trained in monitoring. However, the reality is that at present there are extremely few of such services, they reach only limited numbers of enterprises and it is unlikely they all possess the capacity to undertake monitoring of workplace air. The absence of a clear regulatory definition of what should constitute the technical resources and role of occupational health services (unlike, for example, in countries such as Denmark, where they are more clearly prescribed) and the increased trend towards the commercialisation of such services means that they are driven by market forces to provide the kind of service that employers want. Employers are generally ignorant of the role and significance of OELs the therefore frequently do not require monitoring from prevention services, preferring instead to concentrate their requirements more in areas such as medical surveillance. In countries like Sweden and the Netherlands with prevention services of long-standing, this erodes their capacity to
356 Beyond Limits deliver broad based preventive approaches such as those associated with the detailed monitoring of OELs. In countries where such services are relatively new, the overall pressures are much the same and their effect is to make it unlikely that more than a minority of such services would gain this kind of capacity to begin with. Whatever the capacity of prevention services to deliver monitoring of chemical pollutants in workplace atmospheres, a more significant problem concerns the limited access to such services enjoyed by the majority of enterprises. This seems to be the case regardless of the legislative provisions that control such services and require employers to use them. It is a widespread problem and especially significant in small enterprises. It is generally acknowledged that for a host of reasons these are least well serviced by external prevention services, and relatively inaccessible to inspectorates (Walters 2001). It is therefore far from clear how frequently or how thoroughly monitoring actually takes place in practice in such firms, or with what results. In all these respects therefore despite the existence of more onerous legislative requirements on the establishment and use of prevention services, as far as the involvement of such services in monitoring workplace exposures in relation to exposure limits, the experience in other EU countries we studied is in practice not hugely different from that in the UK. This would seem to suggest that claims advanced by British health and safety professionals arguing that the stronger legislative arrangements in continental European could be contrasted UK experience in relation to professional support for monitoring of OELs have only limited justification (see Chapter 4). One corollary of poor access to and service by expert prevention services is poor awareness of the existence/meaning of OELs. As we have already noted this is a welldocumented feature of owner/managers in many small enterprises that use chemicals in the UK (HSE 1997). There is somewhat of a cyclic effect here - where employers are unaware of the significance of OELs they are unlikely to engage the services of prevention services to monitor airborne exposures. Equally they are unlikely to do so because of the prohibitive costs involved. As such, they will not benefit from any educational/awareness raising effects that might result from contact with prevention specialists. Regulators and trade union specialists interviewed during the study were often only too aware of this cycle and it was one of the reasons why they advocated the kind of alternative strategies we have already discussed - because, to a large extent they remove the need for employers to make informed decisions about risk management strategies for chemical hazards.
Conclusions: Beyond Limits
357
THE WAY FORWARD? A new regulatory paradigm for OELs in chemical risk management?. We have noted that the development of a regulatory function for OELs (as opposed to their previous technical/specialist reference function) has helped to create quite elaborate systems for agreeing OELs at national (and EU) level. In these systems, considerable efforts have been made to ensure clarity in the distinction between scientific deliberations on risks to health and the economic/political discussion of what is feasible in terms of exposure levels at the workplace. But there is a contrast between the sophisticated national systems for the adoption and review of OELs and practices at the workplace level, where in the majority of workplaces that use hazardous chemicals it would seem that OELs play a relatively minor role in day-to-day decision making on risk management. While national level systems (quite rightly) involve wide-ranging expertise and rigorous debate, within many workplaces there seems to be a substantial problem of understanding amongst duty-holders concerning the meaning and appropriate use of OELs. This is a widespread finding in our national studies. In some cases the development of a regulatory function for OELs has arguably worsened the misconceptions about their meaning - illustrated for example by a tendency in many countries to regard the numerical value of an OEL as an absolute distinction between safe and unsafe exposure, by debates about what constitutes a low/moderate/high risk such as in Italy, and by negotiations for exemptions from requirements on the use of competence in chemical risk management for the members of craft associations such as in Greece. These contradictions cannot be separated from the broader issues of transparency, public trust and public understanding of the development of governance strategies for risk regulation more generally. There are a number of related issues here, all of which need to be addressed if a wider appreciation of the strengths and weakness of using OELs in managing the risks of working with hazardous chemicals is to be achieved. And there would seem to be a strong case for considering what can be done to counter the mythology of absolutes that seems to surround the use of numerical values in risk assessment. Even where their meaning is understood, the role of OELs as tools in prevention strategies for chemical risk management at the workplace may still be a relatively limited one. While regulation is widely regarded as an important stimulus, we see quite clearly that technological development is the primary driver of improvements in reducing exposure to dangerous chemicals in most sectors and in most countries that we have studied. We also see that specification standards for processes and machinery play an important part in control strategies, as do estimated exposure scenarios and control
358 Beyond Limits guidance related to them. While OELs have some significance as reference points in the development of specification standards, these standards are often used as evidence that there is no requirement for monitoring to test compliance with OELs in workplaces in which machinery and processes meeting them are in use. In Germany and in the Netherlands for example, in the case of some substances this has meant substitution and closed/recovery systems while in the case of others, the advocacy of the use of abatement systems and other dust reduction facilities as with wood dust for example. The connection between monitoring compliance with the OEL and influencing these improvements is tenuous. In Germany in the case of wood-dust we have seen that the main emphasis of the regulatory authorities and other professional agents of the OHS system concerns designing model work-places that guarantee the compliance with the TRK value, by using recognised abatement and dust reduction facilities. Employers are not required to measure airborne exposure and labour inspectors simply check that certain machines are present and are working in the way they should. Measurement therefore becomes an exceptional requirement rather than a normal expectation. As such, OELs may have an important value in determining the specification standards for machines, but a reduced importance as reference points for routine airborne monitoring - because the argument goes that the need for monitoring may itself is much reduced in such circumstances. Thus, the performance standard paradigm that has underpinned professional use of OELs, is often replaced by the (older) notion of specification standards in the practices of chemical risk management, not only carried out by duty holders but also encouraged and supported by the demands of regulatory agencies. Similarly, the strategy of substitution has the effect of bypassing the need for OELs for hazardous substances, since such substances are, by definition, replaced by safer ones. While this does not exactly render the role of OELs/performance standards redundant, it certainly affects their significance in practical and achievable strategies in risk management and arguably requires a rethinking of their role in developing the philosophy behind chemical risk management at the workplace. As we outlined in Chapter 4 in the case of the UK, the development of the control strategies that are packaged in the COSHH Essentials approach developed in parallel to related strategies to estimate exposure, such as the Estimation and Assessment of Substance Exposure (EASE).470 Together they are claimed to provide a comprehensive EASE originally developed in the UK but is increasingly used in other EU countries. It is a model that postulates that the concentration of a substance can be predicted for a particular situation
Conclusions: Beyond Limits
359
strategy to assess risks of likely exposure and to recommend appropriate strategies for risk management and control in situations where employers for various reasons may not have access to appropriate expertise to monitor exposure and where arguably monitoring is not necessary because likely exposure can be predicted and appropriate controls implemented to prevent harmful consequences (Northage 2005). Converging chemical risk management scenarios in the EU? Although one of the consequences of the growth in significance of the EU as a legislative and policy making body has been greater harmonisation in many aspects of risk regulation, most comparative studies nevertheless stress the continuity of divergence amongst national systems. In common with other authors,471 we are at pains to stress that there are many features of national systems for health and safety and strategic approaches to regulating chemical risk management that remain divergent. However in terms of the role of OELs within these systems, it is the convergence of experiences and approaches that is most striking. This is particularly true of: -
national systems for setting and reviewing OELs and their position of such systems within OHS regulatory systems the limited role of OELs in control measures in use in managing chemical risks and in workplace OHS management the limited extent to which reference is made to OELs in monitoring risks management by the regulatory agencies the limited understanding of the meaning and significance of OELs by duty holders and notions concerning their meaning prevalent in wider society measures that are used in addition to or instead of OELs to determine control measures and good chemical risk management practice.
where exposure data is not available though analogy with similar situations provided that judgements are calibrated with reference to sufficiently robust measured exposure data. It seems that despite some recognised limitations, the development of this approach over the past decade or so has resulted in a model that most commentators regard as reasonably accurate for inhalation closures (Tickner et at 2005). This is not the place to discuss the convergence/divergence debate in detail. However the point about continued divergence in national systems after the imposition of the harmonising effects of EU Directives is discussed at some length by for example, Walters 2002, Vogel 1993 and 1998, and Unger and van Waarden 1995.
360 Beyond Limits Convergence is also apparent if we compare the salient points of our conclusions with the key objectives for the revised British system that were identified in the HSC's Discussion Document that led to the introduction of the revised OEL Framework in the UK in 2005. It will be recalled from Chapter 4 they were that OELs should: -
control risks to health be readily understood and accessible be legally enforceable comprehensive comply with EC legislation flexible and able to take on board new developments in science and technology provide incentives to reduce exposures.
Controlling risks to health was clearly the aim of all of the OEL systems we investigated. The extent to which they were able to do so however, was subject to considerable limitations, of scope, application and user understanding that are similar to those experienced in the UK. None of the systems we investigated had been subject to any detailed quantitative evaluation concerning their effectiveness either in terms of health outcomes or, more narrowly, in terms of their use in risk assessment.472 The qualitative evaluations on which we drew suggested broad agreement about the limitations of OELs but at the same time pointed to a widespread belief in their necessity. There were variations in the extent that it could be argued that OELs were based on clear and coherent principles but general agreement that nowhere were they either readily understood by the majority of employers or accessible to them. As far as professional input in their use was concerned, despite the existence of legal requirements on prevention services in most of the countries we investigated, there was shortage of professional input in the application of OELs in workplaces in these countries (Germany is a possible exception). There was a widespread notion that such input was least accessible to employers in small and medium sized enterprises and that these were the duty holders that were least aware of the significance and role of OELs. There was also a worrying notion expressed in some countries that there had been a
The field work for the study was undertaken before the cost/benefit studies on the likely economic impact of REACH were published. While none of these studies concern themselves specifically with the role of exposure limits, they do address the extent of ill-health related to exposure to chemicals and to some extent evaluate the capacity of existing systems to reduce such harm.
Conclusions: Beyond Limits
361
decline in the extent to which prevention services still had the capacity to provide the professional input required. In the UK a new national approach to the provision of advice and information on occupational health and safety is scheduled to commence operation in 2006. Known as Workplace Health Direct, it is based on a model that has already been piloted in different regions and industries and comprises a three level scheme that is intended to provide confidential health and safety and return to work advice to employers, including those in small and medium sized firms. The first level will be a national telephone advice service, the second, a* problem solving service at regional level while the third, will be a signposting service whereby employers who are in need of specialist advice will be referred to independent consultants such as occupational hygienists, ergonomists or other specialists. The model offers interesting possibilities when viewed in conjunction with schemes on chemical risk management such as COSHH Essentials that are already operating in the UK and clearly there is a conceptual fit between its approach to providing increasingly specialised advice at three levels and the kind of support that employers might need to deliver appropriate risk management strategies for chemical use under REACH. However, the scheme is not yet operational, there are some uncertainties concerning the level of funding it would need to function effectively and what would be the likely balance in the sources of such funding - or indeed what would need to be removed from the existing system for occupational health support in the UK in order to resource it. OELs were theoretically legally enforceable in all countries. The extent to which they are enforced however is limited. Records are hard to locate or understand, but the strong evidence of observers was that in all countries enforcement, for many reasons that have already been discussed, is not an option practised widely. At the same time, regulation is widely perceived as an important driver of improved chemical risk management, however, OELs are only one aspect of such regulation. Systems for setting OELs in northern Europe are sophisticated and highly developed. But even the most developed systems only deal with a small minority of chemical substances that are in use in industry. None could be said to be comprehensive in coverage. There is therefore discussion of the means with which such frameworks for OELs could be applied to generic groups of substances. Generally in these countries, strategies of substitution are based on quite thorough investigation of possible effects of alternative substances and the ethos of substitution is not one that would encourage the introduction of inadequately evaluated and potentially harmful substances.
362 Beyond Limits Compliance with EU level requirements is an issue that is under review in all countries. The anticipated division between north and south is also evident here. The concerns of northern European countries are with the extent to which existing systems need to be adapted and the extent to which the achievement of compatibility with EC requirements can be achieved without reducing the quality of these existing systems, m southern European countries EC requirements are sometimes necessitating more fundamental reforms. There is some questioning of compatibility of these changes with national approaches (such as the constitutional debates in Italy) and the possible influence on quality. In addition, there are several other issues that are the subject of national debate in Italy and Greece which seem to be mainly to do with the extent of duties under the legislation introduced to transpose the EC requirements and the possibility of exemptions from its coverage. There was some concern in these countries about delays that occurred in the process of review and the resource intensive nature of the process of evaluating new information and reconsidering OELs in its light. OEL systems were generally flexible enough to allow for the development of substitution and specification standards. The position in relation to the discretion of inspectors to demand improvement of exposures to below the OEL was less clear. Concerns were suggested about the role of an OEL regulatory framework in which numerical values are not properly understood, resulting in employer resistance to reducing exposure to as low as is technically feasible. Technological change is the primary driving force for improving the management of risks from chemical hazards. Substitution and specification standards operate alongside OELs in most countries we studied. At the same time concerns were raised about the misuse of OELs that result from faulty understanding of their meaning, which could include contributing a barrier to reducing exposure and countering demands for the application of good practice from regulatory inspectors. In Chapter 4 we noted that revision of the OEL framework in the UK led to the adoption of a single limit approach intended to combine good practice with special arrangements for carcinogens. Our investigations of practices in other countries would suggest that this is a step in the right direction and consistent with the approach desired by most of the regulators and stakeholders involved in our study. It would for example: -
encourage (or at least not discourage) the development of substitution strategies and the greater use of specification standards within a broader framework for chemical risk regulation
Conclusions: Beyond Limits -
363
not prevent inspectors from requiring improvements that were technically feasible help to reduce some of the misconceptions around the notion of a 'safe limit' allow the enforcement of good practice and avoid the necessity of sophisticated monitoring in some situations where it is neither economically feasible nor really necessary.
However, it is by no means certain that such reforms would alone be sufficient to address the problems of achieving widespread compliance with measures to assess and manage chemical risks. They will not solve the problems of risk perception and risk communication that seem to be inherent all the national systems for setting and using OELs that we have considered. While they may help improve the practice of risk management of hazardous chemicals amongst some duty-holders that currently fail to deal adequately with this subject, our analysis of wider European experience suggests there is no 'one size fits all* approach that can be applied successfully to this subject. Such reforms that are currently being canvassed are unlikely to reach all users, to particular, they will not guarantee that the practice of understanding and using OELs would be extended to substantially more duty-holders amongst owner managers in small enterprises, since their problems of compliance are considerably more wide ranging than can be addressed by this type of reform alone (Walters 2001). Neither do they address other concerns that we have raised, such as the question of access to services with the competence and resources to undertake monitoring or the extent to which the regulatory inspectorates are themselves sufficiently resourced and skilled to always deal adequately with OELs. We conclude therefore, that if substantial improvement is sought in the way in which all firms manage the risks of using hazardous chemicals, the kind of revision recently introduced in the UK needs to be part of a wider reform. It needs especially to address the issue of risk communication in rather more fundamental ways than at present. It requires integration within additional reforms to ensure the availability and use of professional preventive services that are sufficiently competent to undertake the monitoring of hazardous chemicals. Means to effect such availability and use would also have to take account of the particular challenges represented by small enterprises, which would additionally require special attention being paid to their education and information needs. Above all, the creation of an ethos of risk awareness for all involved in the use of hazardous chemicals is necessary. Some small steps can be made in this direction by clearer meanings for OELs included in the new OEL Framework.
364 Beyond Limits We have noted that best practice in Germany suggests that combinations of indicators of safe materials, plant and processes can be used to achieve greater worker protection from chemical risks without necessarily resorting to extensive monitoring. However, best practice in countries such as the Netherlands and in Sweden indicates that other measures to encourage participation, to make use of the skills and experience of trade union health and safety representatives and to engage with manufacturers and suppliers are also required. As the Dutch experience shows, substitution principles and specification standards steered by regulatory strategies can be arrived at by agreement between workers representatives, employers, manufacturers and suppliers, aided by the use of competent professional advice, if participants are empowered to make such agreements. OELs, far from being redundant in these processes have a variety of potential roles to play, ranging from the provision of information on hazardous substances, through design specification, to monitoring performance standards. These latter steps would seem to represent important ways forward. European Union strategic approaches to regulating chemical risk management look set to pay particular attention to supply chains in the future. They will place not only more stringent obligations concerning product stewardship on suppliers, but also will apparently require particular responses from users. The approaches described above at the level of the workplace appear to be in step with these regulatory developments, since they focus on ways of achieving improved risk management of hazardous chemicals across the full range of users, and imply more generic models of exposure assessment and control that are accessible and understandable to users with have neither the will or capacity to engage with more sophisticated exposure monitoring. The position of OELs will remain significant at international, national and sectoral levels as reference tools in the processes involved in setting specification standards OELs. Moreover, these developing trends also do not entirely preclude their role in workplace monitoring when it is required in special circumstances and they will remain useful to the specialists that are engaged in such work. Perhaps the most significant issue for the future is how to ensure that such approaches are implemented effectively. The attention that has been paid to the development of more comprehensive risk assessment of chemical substances, to models of exposure assessment and to control banding and to the role of OELs in all this is focussed on what are essentially supply issues. While it is important that their implications for the role of OELs are understood it is also imperative that at the same time a better understanding of the processes that might lead to greater user engagement is also achieved. Failure to do so risks the creation of a further elaborate system for regulating chemical supply that fails to focus sufficiently on the means to deliver effective
Conclusions: Beyond Limits
365
outcomes at the level of workplace use and fails to address the known weaknesses of the existing system. While supply chains present some useful opportunities to increase leverage on both suppliers and users of products, it also needs to be recognised that the existence of modern supply chains and the extended business networks of which they are part are to a large extent aspects of trends in modern business practice in which organisations have sought to off-load transaction costs and reduce their responsibilities for the care of workers who would otherwise remain under their control. The rationale inherent in such chains is often concerned with the transfer of risk, which takes place against a background of unequal and exploitive contracting power. Added to this, modem supply chains are often the result of fragmentation of larger, previously whole systems and the export of work to less sophisticated systems of control, where workers interests are poorly represented. All of this means that such environments are less, rather than more, likely to be conducive to prioritising health and safety concerns as well as being less likely to engage in systematic health and safety management and they are further likely to present difficulties in monitoring actual performance in health and safety. Relying on such scenarios to improve health and safety outcomes in terms of chemical risk management without additional checks and balances also being in place does seem to be leaving rather a lot to chance. Therefore, while it is clear that product stewardship and user engagement are necessary elements in improving risk management of hazardous chemicals and that techniques embodied by modelling exposure assessment and control banding may be useful tools, the significant issue would seem to be how to achieve the appropriate levels of stewardship and user engagement in practice since it cannot be assumed that supply chains or the business rationalities behind them will automatically lend themselves to such outcomes. We think this implies further regulatory engagement of some kind. Current notions of 'smart regulation' embrace a wider range of regulatory strategies as well as those of inspection and enforcement that are traditionally associated with the work of regulatory agencies in health and safety. They include for example, encouraging corporate social responsibility and promoting the business case for health and safety through education and persuasion of employers; using partnership approaches, gaining agreements for joint actions between employers and trade unions and increasing links with worker representatives. But none of these strategies replace inspection or enforcement action, which, as the limited evidence that exists demonstrates, still remain powerful influences on employer behaviour. There is less evidence available concerning the effectiveness of the range of new approaches to
366 Beyond Limits 'smart regulation'. It seems most likely however, that none of these approaches are mutually exclusive and also what works in a particular sector or business relationship may not work so well in other settings. What therefore seems to be required to achieve improved risk management of chemical hazards is a combination of regulatory strategies and risk assessment and control tools that are appropriate to particular situations and that reflect calculations of their effectiveness. This in turn means that in the risk management of hazardous substances considerably more needs to be understood about what works, why it works and how much it costs to make it work in different supply chain scenarios and work environments than is currently the case. Developing such an understanding means more research and analysis of these scenarios is required. Currently much of what we know about the effectiveness of initiatives that target levers and influences in chemical supply chains to improve health and safety is descriptive rather than analytical and is often based more on opinion than on empirically grounded research. This means that emergent policies in this field are in great danger of being based on political and ideological notions rather than being in any true sense evidence based. There is also a danger that without proper understanding of the nature of different types of business networks and supply chains, the way they operate in different sectors and how they may be influenced, these emergent policies will not only be based on inadequate evidence of their success but will also be generalised to situations in which the supports necessary for their success are in any case absent. If future chemicals strategy is to be effective in engaging with both suppliers and users of chemical substances to improve the protection of workers then it is clear that such strategy must be based on a sound understanding of what supports and sustains successful prevention practice. While not unimportant, the nature and role of exposure limits in these situations is in many ways a secondary consideration to that of understanding the social and economic processes that influence risk perception, communication and management in the various scenarios that constitute the modern work situations in which chemical risks are experienced.
367
REFERENCES Adolph, A., Lehnert, M., Zoglauer, H. (1997). Umsetzung der TRGS 553 "Halzstaub" in Schreinereien der Bundeswehr, Gefahrstqffe - Reinhaltung der Luft (1997) Nr. 5, S. 299 AFS (2001). Systematiskt arbetsmiljbarbete, Arbetarskyddsstyrelsensfb'rfattningssamling 2001: 1, The Swedish Work Environment Authority, Solna AIHA/CMA (American Industrial Hygiene Association/ Chemical Manufacturers Association) (1996). An International Review of Procedures for Establishing Occupational Exposure Limits, Fairfax: American Industrial Hygiene Association. Allen, B. (2004). COSHH Essentials 'a blunt tool' Occupational Health Review, 112, pp 9-10. Athens Labour Centre (1998). Research on Living and Working Conditions of Workers in Athens, Athens: Athens Labour Centre, (in Greek). AV (1989). Arbetarskyddsverkets versamhetsberSttebe 1988/89, The Swedish National Board of Occupational Safety and Health, Solna. AV (2000). Arbetarskyddsverkets verksamhetsberSttelse 1999, The Swedish National Board of Occupational Safety and Health, Solna. Avino, P., Cristaudo, A., Gelormini., A., Grosso, F., Marconi, M., Papacchini, M., Pellici, M. and Carlizza, F. (2003). Dangerous Substances Handle with Care, A view from the Member States: Italy, Magazine of the European Agency for Safety and Health at Wont No 6 pp., 15-18, Bilbao: European Agency. Ayres, I. and Braithwaite, J. (1992). Responsive Regulation: Transcending the Deregulation Debate, Oxford Socio-Legal Studies, Oxford University Press, New York Bardach, E., and Kagan, R. (1982). Going by the Book; the Problem of Regulatory Unreasonableness, Temple University Press, Philadelphia. Beck, U. (1992). Risk Society: Towards a New Modernity, (trans. Ritter, M.), Sage, London. Bikos, P.C. and Scarlatos, P. (2003). Practical application of E legislation on chemical hazards in the Hellenic Chemical Industry -results of a pan-hellenic survey, 8th International Symposium oflSSA Research Section, Abstracts, pp260-261, Athens. Bock, W., Brock, T. H., Stamm, R., Wittneben, V (1999): Altstoffe - Exposition am Arbeitsplatz, Beitrdge zur Risikobewertung chemischer Stoffe am Arbeitsplatz I Rahmen des EUAltstqffpragramms (BGAA-Report 1/99); Hrsg: Hauptverband der gewerblichen Berufsgenossenschafien (HVBG), Oktober 1999 Briggs, D. and Crumbie, N. (2000). Characteristics of people working with chemical products in small firms, WS Atkins, CRR278/2000, HSE Books, Sudbury, Brooke, I. M. (1998). A UK scheme to help small firms control health risks from chemicals: toxicological considerations, Annals of Occupational Hygiene, Vol. 42, No 6 pp 377-390.
368 Beyond Limits Bruun, N. (1994). Transformation of Nordic Industrial Relations, in Transformation of Nordic Industrial Relations in the European Context, IIRA 4 th European Regional Congress, Helsinki. Carter, J. T. (1989). Indicative criteria for the new occupational exposure limits under COSHH, Annals of Occupational Hygiene, Vol. 33, pp 651-2. Castleman, B. I. and Ziem, G. E. (1988). Coorporate Influence on Threshold Limit Values, American Journal of Industrial Medicine, 13: 531-559. CEC, (1998). Commission Working Document: Report on the operation of Dir. 67/548, Dir. 88/379, Reg 793/93 and Dir. 76/769. Office of Official Publications of the European Communities, Luxembourg. SEC (1998) 1986 final. CEC - Commission of the European Communities (2001). White Paper: Strategy for a Future Chemicals Policy, COM (2001) 88 final, Brussels 27.2.2001. CEFIC (2003). Occupational Diseases in the European Chemical Industry - Impact of REACH, CEFIC Comments 8 July 2003, Brussels: CEFIC. CEFIC (2004). Facts and Figures, The European Chemical Industry in a worldwide perspective, www.cefic.org/factsandfigures. Chemical Industries Association (CIA) (1993). Safe Handling of Colourants 2: Hazard Classification and Selection of Occupational Hygiene Strategies, London: Chemical Industries Association. Chemical Industries Association (CIA) (1997). Control of Substances Hazardous to Health — Guidance on Allocating Occupational Exposure Bands (Regulation 7), London: CIA. Chemicals Acts / Gesetz zum Schutz vor gefahrlichen Stojfen (Chemikaliengesetz - ChemG) In der Fassung vom 25. Mi 1994 (BGB1.1 1994 S. 1703;.1994 S. 1963; 1994 S. 2705; 1997 S. 1060; 1998 S. 950; 2000 S. 1045,2048; 2001 S. 843,2001 S. 2331) CIGL, (2002). / Valorie-limite per I'esposizione professionale a Sostanze conceroge, Fiere, Modena. Cohen, A., Colligan, M., Berger, P. (1985). Psychology in health risk messages for workers, Journal of Occupational Medicine 1985; 27(8): 543-551. Colebatch, H. K. (1989). The concept of regulation in the analysis of the organised world, Law andPolicy, ll/l,pp.71-237. Coodinamento Tecnico per la Sicurezza nei Luoghi di lavoro delle Regioni e delle Provincie autonomie (2002). Linee guida per lapplicazione dei Titoli VII e Vll-bis del D. Lgs. 626 94, Proceedings of Congress: Risch 2000, Prevenzione e Protezione da agenti chimici pericolosi, Modena 551-773. Cook, W. A. (1985). History of ACGIH TLVs Annals of the American Conference of Governmental Industrial Hygienists 12:3-9. Cook, W. A. (1987). Occupational Exposure Limits — Worldwide, Akron OH, American Industrial Hygiene Association. Crouch, C. (1994). Industrial Relations and European State Traditions, Clarendon Press, Oxford.
References
369
Davis, C. (2004). Making companies safe: What works? London: Centre for Corporate Accountability. Detering, B., Heimann, M., M6cklinghoff, K., Miiller, L., Poppe, M., Wfistefeld, B. and Wolf, J. (1999). 1st der deutsche Luftgrenzwert fur Holzstaub mit einer fortschrittlichen Staubminderungstechnik in der Praxis uberall einzuhalten? Gefahrstoffe - Reinhaltung der Luft (1999) Nr. 11/12, S. 419; Detring, B., Neuschaefer-Rube, J., Poppe, M., Woeste, W., Wilstefeld, B., Wolf, J. (2000): Staubintensive Handarbeiten bet der Holzbearbeitung im Handwerk Gefahrstojfe-Reinhaltung der Luft (2000) Nr 11/12 S.445. Doll, R and Peto, R (1981). The causes of cancer: quantitative estimates of avoidable risks of cancer in the United States today, Journal of the National Cancer Institute, vol.66,1196-308. ECETOC (2004). Targeted Risk Assessment, Technical Report No 93, European Centre for Ecotoxicology andToxicology of Chemicals, Brussels. ECLIPS Project (2004). European classification and labelling of preparations including safety Data Sheets, Final report, Office of Official Publications of the European Communities, Luxembourg. ELINYAE (1997). Threshold Limit Values (TLVs) and Biological Exposure Limits (BELs), ACGIH, Translation, Athens: ELINYAE. (in Greek). ELINYAE (1999). Industrial Solvents: Health and Safety Measures, Athens: ELINYAE (in Greek). ELINYAE (2002). Monitoring for Exposure to Toluene in the Printing /ndustry, Athens: unpublished, ELINAE (in Greek). Epstein, S. S. (2005). REACH: An unprecedented European initiative for regulating industrial chemicals, International Journal of Health Services Vol 35, No 1 ppl-38. Ericson, R. V. and Haggarty, K. D. (1997). Policing the Risk Society, University of Toronto Press, Toronto. European Foundation for the Improvement of Living and Working Conditions (2001) Third European Working Conditions Survey, Luxembourg: Office for Official Publications of the European Community Feron, V. J. (1994). A Critical Appraisal of the Setting and Implementation of Occupational Exposure Limits in the Netherlands; Indoor Environ; 3: 260 - 265. Finnish Institute for Occupational Health (1998J. Occupational Exposure to carcinogens in the European Union!990-1993, Carex, International Information System on Occupational Exposure to Carcinogens, Helsinki: Finnish Institute for Occupational Health. Frick, K. (2002). Sweden: Occupational Health and Safety Management Strategies, in Regulating Health and Safety Management in the EU, Walters D.R.(ed), Brussels, Peter Lang PIE. Frick, K. and Walters D. R. (1998). Worker representation on health and safety in small enterprises: Lessons from a Swedish approach, International Labour Review, 137: 3
370 Beyond Limits Frigeri, G. (1994). Occupational Health Policies in Italy, Working Paper, European Foundation for the Improvement of Living and Working Conditions. Dublin. Gardiner , L. J. and Oldershaw, P. J. (1991). Development of pragmantic exposure control concentrations based on packaging risk regulation phrases, Annals of Occupational Hygiene, Vol.35,158-163. Gefahrstaffinformationssystem der Gewerblichen Berufsgenossenschaften (2002)- GESTIS, Stoffdatenbank, Stand Juli 2002. Georg, H., Heinmann, M., LeBnich, W., Post, G.(1998). Ermittlung der Staubemission von handgefuhrten Elektrawerkzeugenfiir die Hohbearbeitung. Die BG (1998) Nr. 1, S. 36. Gerlinger, T. (2000). Arbeitsschutz und Europdische Integration. Europaische Arbeitsschutzrichtlinien und nationalstaatliche Arbeitsschutzpolitik in Grossbritannien und Deutschland (diss.) Opladen; Leske & Budrich Greenberg, R. S., Mandel, J. S., Pastides, H., Britton, N., Rudenko, L. and Starr, T. B. (2001). A meta analysis of cohort studies describing mortality and cancer incidence among chemical workers in the United States and Western Europe, Epidemiology 12 (6): 727-740. Greenstreet Berman Ltd (2004). Building an evidence base for the HSC strategy to 2010 and beyond: a literature review of interventions to improve health and safety compliance, RR196, Sudbury: HSE Books. Guest, I. (1998). The Chemical Industries Association guidance on allocating occupational exposure, Annals of Occupational Hygiene, Vol. 42, No 6 pp 407-411. Gunningham, N. and Johnstone, R. (1999). Regulating Workplace Safety: Systems and Sanctions, Oxford University Press, Oxford. Hancher, L., and Moran, M. (1989). Capitalism, Culture and Regulation, Clarendon Press, Oxford. Hanson, S. O. (1998). Setting the Limit: Occupational Health Standards and the Limits of Science, New York: Oxford University Press. Hauptverband der gewerblichen Berufsgenossenschaften (Hrsg.) (1999), Seeber A (Mitarb.): BK 1317. Polynewopathie oder Enzephalopathie durch organische Ldsungsmittel oder deren Gemische. Allgemeine und arbeitstechnische Hinweise. Empfehlungen zur arztlichen Begutachtung. Sankt Augustin: HVBG, 1999 (BK-Report, Nr. 3/99. Hessisches Sozialministerium und Hessische Landesanstalt fur Umwelt, Abt. Arbeitsschutz (1989). Bericht zum Gefahrstoff Holzstaub, Grundlagen und Ergebnisse einer hessischen Schwerpunktaktion zur Holzstaubbelastung in der Holzbe- und -verarbeitung (Okt. 1989). Holmlund, L. (2001). Statistics on the internal control classification by the labour inspectors during the year 2000, Swedish Work Environment Authority. Holz-Berufsgenossenschaft (Hrsg) (1998). Holzstaub. Projektbericht zur Umsetzung der TRGS 553 "Holzstaub". Munchen 1998. HSC (2002). Discussion Document on Occupational Exposure Limits (OEL) Framework, Sudbury: HSE Books.
References
"ill 371
HSC (2002a). COSHH enforcement and the role of OELs, Annex 4 Discussion Document on Occupational Exposure Limits (OEL) framework, Discussion Document, Chemical Risk Assessment Unit, HSE, London. HSC (2003). Proposals to introduce a new occupational exposure limits (OEL) framework, Consultative Document, Sudbury: HSE Books. HSC (2004). HSC Enforcement Policy Statement HSC 15, Sudbury: HSE Books. HSE (1993). COSHH - the HSE 1991/1992 evaluation survey, Occupational Health Review, 44, 10-15. HSE (1997). Industry's Perception and Use of Occupational Exposure Limits, HSE Contract Research Report, Sudbury: HSE Books. HSE (2004a). Regulation and recognition: towards good performance in health and safety, Consultative Document, HSE Bootle. Hudspith, B., and Hay, A. W. M. (1998). Information needs of workers, Annals of Occupational Hygiene, Vol 42 No 6 pp 377-390. Hutter, B. M. (1997). Compliance, Regulation and Environment, Clarendon Press, Oxford. Hutter, B. M. (1999). A Reader in Environmental Law, Clarendon Press, Oxford. Hutter, B. M. (2001). Regulation and Risk: Occupational Health and Safety on the Railways, Oxford University Press, Oxford. Hyden H. (1992). Work environment' In: Bruun N., B. e tal., The Nordic Labour Relations Model: Labour Law and Trade Unions in the Nordic Countries — Today and Tomorrow. Dartmouth, Aldershot ILO (1978). PIACTReport to the Greek Government, International Labour office, Geneva. MPELNETWORK (2002). Good Practice Facts for Printers, Athens: IMPELNETWORK (in Greek). James, P. and Walters, D. R. (1999). Regulating Health and Safety at Work: The Way Forward, London: Institute of Employment Rights. James, P., Vickers, I., Smallbone, D. and Baldock, R. (2004). The use of external sources of health and safety information and advice: the case of small firms, Policy and Practice in Health and Safety. Vol2,1, pp. 91-104. Jassanoff, S., Markle, G. E., and Pinch, T (eds.) (1995) Handbook of Science and Technology Studies, Sage London, Johansson, A. (1989). Tillvaxt och klassamarbete - en studie av den svenska modellens uppkomst. Tiden, Stockholm. John Kingston Associates (2001). Development of an information-based approach to selfregulation of health and safety in small firms, CRR 330/2001, HSE Books, ISBN 0 7176 1990 7, or www.hse.gov.uk/research/content/crr/index.htm. Karageorgiou, A. et al. (2003). Achieving Safe Chemical Handling in Metal Fabricating Sector, 8th International Symposium oflSSA Research Section, abstracts, pp.309, Athens).
372 Beyond Limits Karageorgiou, A., Jensen, P.L., Walters, D. R. and Wilthagen, T. (2000). Risk Assessment in Four Member States of the European Union, in K. Frick, P.L. Jensen, M. Quinlan, and T. Wilthagen eds, Systematic Occupational Health and Safety Management, Pergamon, Oxford. Kogevinas, M. (1995). Carex - Most Common Occupational Exposures to IARC Agents in Greece (1990-93), Barcelona: JMAS. Kuhn, T. S. (1970). The Structure of Scientific Revolutions, Chicago, University of Chicago Press. KYAE (2001). Methods of Sampling and Determination of Chemical Agents in the Work Environment, T*. Ed. Athens KYAE (in Greek). La Pegna, P. and Terracina A., (2004). Implementation of Council Directive 98/24/EC in Italian legislation: some peculiarities and characteristics, Proceedings of the §'* International Symposium of ISSA Research Section: Tools for the application of European Directives on Health at the Workplace: The Example of Chemical Risk, Athens: Elinyae. LanderausschuB fur Arbeitssehutz und Sicherheitstechnik (1996). Musterleitfaden tur Umsetzung der Gefahrstqffverordnung und der TRGS 553 "Holzstaub" mm Schutz vor den Gefahren durch Holzstaub (LV3), Feb. 1996 Leigh, J., Macaskill, P., Kuosma, E. and Mandryk, J. (1999). Global burden of disease due to occupational factors, Epidemiology, 10 (5) 626. Maidment, S. C. (1998). Occupational hygiene considerations in the development of a structured approach to select chemical control strategies, Annals of Occupational Hygiene, Vol 36, pp 601607. Mendeloff, J, M. (1988). The Dilemma of Toxic Substance Regulation, Cambridge, MA: MIT Press. Middlesex University Business School (2004). Cultural influences on health and safety attitudes and behaviour in small businesses, RR150, ISBN 0 7176 2742 X, HSE Books, £20 or at www.hse.gov.uk/research/rrhtm/rrl 50.htm. Min. Social Affairs and Employment (2004). Occupational health and safety covenants: just what we need, The Hague: SZW/GMA. Min. van Soc. Zaken en Werkgeleglegenheid (2001). Eiddverslag Inspectieproject Metaalproducten 2000, Min. van Soc. Zaken en Werkgeleglegenheid, Arbeidinspectie. Money, C. D. (1992). A structured approach to occupational hygiene in the design and operation of fine chemical plant, Annals of Occupational Hygiene, Vol 42 No 6 pp 391-400. Morrell, S., Kerr, C , Driscoll, T., Taylor, R., Salkeld, G. and Corbett, S. (1998). Best estimate of the magnitude of mortality due to occupational exposure to hazardous substances, Occupational and Environmental Medicine, Vol. 55: 634-641. Musu, T. (2004). REACHing the workplace: How workers stand to benefit from the new European policy on chemical agents, European Trade Union Technical Bureau for Health and Safety, ETUC, Brussels. Naumann, B. D., Sargent, E.V., Fraser, W. J., Becker, G. T. and Kirt, G. D. (1996). Performance based exposure control limits for pharmaceutical active ingredients, American Industrial Hygiene Journal, Vol 57,33-42.
References References
373
Nelkin, D. (ed) (1992). Controversy: Politics of Technical Divisions, 3 rd ed. Sage, London. Neubert, D., Borchert, G., Gericke, C , Hanke, B., Beckmann, G. (2001). Neubert, D., Borchert, G., Gericke, C , Hanke, B. and Beckmann, G. (2001): Toluene Field Study Group: Multicenter field trial on possible health effects of toluene. I. Toluene body burdens in workers of the rotogravure industry. Toxicology 168 (2001), 139 - 157. Nichols, T. (1997). The Sociology of Industrial Injury, Mansell, London. NNI (Standardization Institute of the Netherlands) (1996). Technical Report NPR 5001: Guide to an Occupational Health and Safety Management System, NNI., Nordberg, G. F, Frostling, H., Lundberg, P. and Westerholm, P. (1988). Swedish occupational exposure limits: developments in scientific evaluation and documentation, American Journal of Industrial Medicine, 14: 217-221. Northage, C. (2005). EASEing into the filture, Annals of Occupational Hygiene, 49, No 2 pp 99101. Ogden, T. (1998). The sunset of exposure limits - and the dawn of something better? editorial, Annals of Occupational Hygiene, Vol 42 No 6 pp 355-356. Ogden, T. (2002). Occupational Exposure Limits - Britain tries again, editorial, Annals of Occupational Hygiene, Vol 46 No 5 pp 435-437. Pelissero, G. and Carreri, V. (1997). Contributo alia Storia Organizzativa della Sanita Pubblica Italiana, in A. Grieco and P.A. Bertazzi (eds.) Per una Storiografla Italiana della Prevenzione Occupazionale ed Ambientale, Milano: FrancoAngeli, pp.309-321. Piney, M. (1989). The Development of Chemical Exposure Limits for the Workplace, PhD thesis, University of Aston. Piney, M. (1998). Exposure Limits, Practicability and Health Risks: Arguments for a Paradigm Shift, in Bal R. and Halffman (eds.) The Politics of Chemical Risk: Scenarios for a Regulatory Future, pp 27-73, Dordrecht: Kluwer. Piney, M. (2001). OELs and the effective control of exposure to substances hazardous to health in the UK, HSE FOD. Occupational Hygiene Section, Cardiff. Pitiakoudis, M., Tsaroucha, A., Constantinidis, T.C., Mimidis, K. and Erstatbiou, E., Stathopoulos, G. A. and Simopoulos, C. (2003). 'Occupational exposure to wood dust. Oesophageal and small bowel obstruction by occupational bezoarreport of a case. 8"1 International Symposium oflSSA Research Section, Abstracts, pp. 377-78. Polychroniou, P. (2001), Circular to Safety Inspectors, Athens: Office of the Special Secretary, Head of SEPE, Ministry of Labour (in Greek), Popma, J., Schaapman, M. and Wilthagen, T. (2002). The Netherlands: Implementation within wider regulatory reform, in Regulating Health and Safety Management in the European Union, Walters, D.R. (ed.), PIE, Peter Lang, Brussels. Poppe, M., Detering, B., Neuschaefer-Rube, J., Woeste, W., Wustefeld, B., Wolf, J. (2002). Holzstaubbelastung Arbeitsbereichen der deutschen Holzindustrie. Gefahrstoffe - Reinhaltung der Luft (2002) Nr 6, S.246.
374 Beyond Limits Postle, M., Vernon, J., Zarogiannis, P and Salado, R, (2003). Assessment of the Impact of the New Chemicals Policy on Occupational Health, Final Report for the European Commission, Environment Directorate General, Risk Policy Analysts Ltd, Looden, Norfolk. Remaeus, B, and Westerhohn, P. (2001). Official Supervision and the Occupational Health Service. In: Marklund M. (ed.). Worklife and Health in Sweden 2000. NIWL, Stockholm. Research International (1997). Industry's perception and use of occupational exposure limits, HSE Contract Research Report No 144, HSE Books, Sudbury. Rimmington, J. (2003). The politics of health and safety in the UK: the Health and Safety, Occupational Health Review, 105,35 - 39. Rivest, C. (2002) Italy: the Difficulty of Transposing National Law into Regional Practice, in Regulating Health and Safety Management in the European Union, ed Walters D.R., PIE Peter Lang, Brussels. Roach, S. A. and Rappaport, S. M. (1990). But They are Not Thresholds: A Critical Analysis of the Documentation ofThreshold Limit Values, American Journal of Industrial Medicine 17: 727-753. Robens, Lord Alfred (1972). Report of the Committee of Inquiry into Safety and Health at Work, Cmnd. 5034, HMSO, London. Rolt, D.A. (1987). The aims of legislation, Annals of Occupational Hygiene, Vol. 31 pp 73-80. Royal Society of Chemistry (1996). COSHHin Laboratories, 2ni ed. Cambridge: RSC. Rudiger, H.W.(1999) in BIA-Report 4/99, BeitrEge zum Workshop Fertilitatsstorungen und Fruchtschadigung durch Arbeitsstoffe am 9. und 10. Februar 1998 in Hennef (August 1999). Russell, R. M., Maidment, S. G , Brooke, I. and Topping, M. D. (1998). In introduction to a UK scheme to help small firms control health risks from chemicals, Annals of Occupational Hygiene, Vol 42 No 6 pp 367-376. Ryner, M. (1993). The economic 'success' and political failure' of Swedish social democracy in the 1980's: A historical-structural interpretation. Arbetslivscentrum, Stockholm. Seeber, A., Blaszkewicz, M., Demes, P., Kiesswetter, E., Schaper, M., Sietmann, B., Thriel, C.V., Zupanic, M. (2002). Long term effects of toluene on employees in the gravure industry?. IfADo (Institut fur Arbeitsphysiologie an der Universitat Dormund) Annual Meeting 2002 of the European Rotogravure Association, Barcelona, Spain. Selznick, P. (1980). Law, Society and Industrial Justice, Transaction Books, Brunswick, New Jersey. Senatskommission zur Pruning gesundheitsschadlicher Arbietsstoffe (1996). List ofMAK and BAT Values 1996, Weinham, Deutche Forschungsgemeinschaft. Silk, S. J. (1987). Setting recommended limits for occupational exposure, Annals of Occupational Hygiene, Vol 31, No 1 pp 91-93. Soldatos, A.P, Bakeas, E.B and Siskos, P.A., (2003). Occupational exposure to BTEX compounds of workers in car parkings and gasoline stations in Athens , 8th Int. Symp. oflSSA, pp. 337-338 Athens).
References References
375
Spyropoulos, G. (ed) (2000). Health, Safety and Working Conditions in Greece, Recent Developments and Future Prospects, Athens/Komotini: Sakkoulas Publishers, (in Greek). Stamm, R. (2000) MEGA-Database: One Million Data Since 1972, Applied Occupational and Environmental Hygiene, 16 No. 2, pp. 159-163. Stokinger H.E. (1988). Threshold Limit Values: Any Alternative? American Journal of Industrial Medicine, 14: 231-232. Stokinger, H.E. (1984). Threshold Limit Values, Annals of the American Conference of Industrial Hygienists, 9: 275-281. Sund, B. (1994), The Safety Movement and the Swedish Model, Scand. J. History, 19:41-62. Technical Rule for Hazardous Substances / Technische Regeln fur Gefahrstoffe Nr. 402: Ermittlung und Beurteilung der Konzentration gefahrlicher Stoffe in der Luft in Arbeitsbereichen (TRGS 402). BArbBl. (1997). Nr.l 1 S. 27. Technical Rule for Hazardous Substances / Technische Regeln fur Gefahrstoffe Nr.420 (TRGS 420), Annex 2 - BG/BIA-Empfehlung Nr. 1014 Ausgabe 111/96 Oberflachenbehandlung von Parkett und anderen Holzfuflb6den. Technical Rule for Hazardous Substances / Technische Regeln fur Gefahrstoffe Nr. 553: Holzstaub (TRGS 553).BArbBl. (1999). Nr. 3 S. 52, zuletzt geandert BArbBl. (2002) nr. 3 S. 70. Technical Rule for Hazardous Substances / Technische Regeln fur Gefahrstoffe Nr. 900: Grenzwerte in der Luft am Arbeitsplatz 'Luftgrenzwerte' (TRGS 900). BArbBl. (2000) Nr. 10. S. 34, zuletzt geandert BArbBl. (2002). Nr. 3, S. 71. Technical Rule for Hazardous Substances / Technische Regeln fur Gefahrstoffe Nr. 901: Begrilndungen und Erlauterungen zu Grenzwerten in der Luft am Arbeitsplatz (TRGS 901). BArbBl. (1997). Nr. 4, S. 42, zuletzt geandert BArbBl. (1998) Nr. 10, S. 74. Technical Rule for Hazardous Substances / Technische Regeln fur Gefahrstoffe: Biologische Arbeitsplatztoleranzwerte - BAT-Werte - (TRGS 903) . BArbBl. (2001) Nr. 4. S. 53, zuletzt geandert BArbBl. (2002). Nr. 5, S. 115. Technical Rule for Hazardous Substances / Technische Regeln fur Gefahrstoffe Nr. 905: Verzeichnis krebserzeugender, erbgutverandernder oder fortpflanzungsgefahrdender Stoffe (TRGS 905). BArbBl. (2001). Nr. 3, S. 97, zuletzt geandert BArbBl. (2002) Nr. 5, S. 116. Tickner, J., Friar, J., Creely, K., Cherrie, J.W. Pryde, D.E. and Kingston, J. (2005). The development of the EASE model, Annals of Occupational Hygiene, 49, No 2 pplO3-l 10. Tischer, M. Brendendiek-Kamper, S. and Poppek, U. (2003). Evaluation of the HSE COSHH Essentials Exposure Predictive Model on the basis of BauA field studies and existing substances exposure data, Annals of Occupational Hygiene, Vol 47 No 5 pp 557-569. Tompa, E., Trevithick, S. and Mcleod, C. (2004). A Systematic Review of the Prevention Incentives of Insurance and Regulatory Mechanisms for Occupational Health and Safety, Toronto: Institute for Work and Health. Topping, M. D., Williams, C. R. and Devine, J. M. (1998). Industry's perception and use of occupational exposure limits, Annals of Occupational Hygiene, Vol. 42 No 6 pp 357-366.
376 Beyond Limits Topping. M. (2001). Occupational exposure limits for chemicals, Occupational and Environmental Medicine, Vol 58:138-144. Unger B. and van Waarden F. eds. (1995). Convergence or Divergence: Internationalisation and Economic Policy Response. Avebury: Aldershot. Visser, J. and Hemerijck, A. (1997J, A Dutch Miracle. Job Growth, Welfare Reform, and Corporatism in the Netherlands. Amsterdam University Press, Amsterdam. Vogel, L, (1998). Prevention at the Workplace: the impact of Community Directives on preventive systems in Sweden, Finland, Norway, Austria and Switzerland, European Trade Union Technical Bureau for Health and Safety, Brussels. Vogel, L. (1993), Prevention at the Workplace. An initial review of how the 1989 Community Framework Directive is being implemented. Brussels: European Trade Union Bureau for Health and Safety. Vogel, L. (1998). Prevention at the Workplace: the impact of Community Directives on preventive systems in Sweden, Finland, Norway, Austria and Switzerland, European Trade Union Technical Bureau for Health and Safety, Brussels. Vogel, L. (2001). Special report: Preventive services, TUTB Newsletter, No 21, ppl9 - 37. Walters, D. R. (2001). Health and Safety in Small Enterprises: European Strategies for Managing Improvement, Peter Lang, Brussels. Walters, D. R. (2001). Health and Safety in Small Enterprises: European Strategies for Managing Improvement, Peter Lang, Brussels. Walters, D, R. (2002). Working Safely in Small Enterprises in Europe, Brussels, ETUC. Walters, D. R. ed. (2002). Regulating Health and Safety Management in the European Union, PIE Peter Lang, Brussels. Walters, D. R. Grodzki, K. and Walters, S. L. (2003). The role of Occupational Exposure Limits in the health and safety systems of EU Member States, HSE Research Report 172, Sudbury: HSB Books. Walters, D.R. (2002). Regulating Health and Safety Management in the European Union, Brussels: PIE, Peter Lang. Walters, D.R. (ed.) (1996). The Identification and Assessment of Occupational Health and Safety Strategies in Europe, Dublin: European Foundation for the Improvement of Living and Working Conditions, vol. 1: The National Situations, 220p. WEA (2002). http:Avww.av.se/English/docs/systematic.shtm. WEA (2004). Plan of Activity 2004-2006, Stockholm: Work Environment Authority. Wilders, M. (2002). Risk-based TLVs for carcinogens: Do they add to worker protection? In: Proceedings of the INRS Expert Seminar "Hazardous Substances in the Workplace Minimising the Risks ", Paris 2002. Wilthagen, T. (1994), Reflexive rationality in the regulation of occupational health and safety, in R. Rogowski and T. Wilthagen, Reflexive Labour Law, Kluwer, Deventer.
References References
"ill 377
Wiseman, J. and Gilbert, F. (2002). COSHH essentials: survey of firms purchasing this guidance, Contract Research Report 434, Sudbury: HSE Books Wiseman, J. and Gilbert, F. (2002). COSHH essentials: survey of firms purchasing this guidance, Contract Research Report 434, Sudbury: HSE Books. Work Environment Authority (2002). Chemicals Control at the Workplace - Limiting Chemical Hazards at Work, Stockholm: Work Environment Authority. Wriedt, H. (2003). The European trade union approach: threshold limit values as an instrument to reduce real life exposure of workers to carcinogens, paper presented at the National Conference on the Prevention of Risks of Cancer at the Workplace, Pisa, 20-22 February 2003. Wynne, B. (1994). Public understanding of science, in Jassanoff, S., Markle, G. E., and Pinch, T (eds.) Handbook of Science and Technology Studies, Sage London Wynne, B. (1996). May the sheep safely graze: a reflexive view of the expert-knowledge divide, in Risk, Environment and Modernity, eds. Lash, S, Szerszybski, B. and Wynne, B. Sage, London. Ziem, G.E. and Castleman, B.I (1988). Threshold Linit Values: Historical Perspectives and Current Practice, Journal of Occupational Medicine 31: 910 - 918.
This Page is Intentionally Left Blank
Annex I Websites of Ministries and other bodies involved in H&S4 Country
Name of the Institution / body etc. in the original language
Name of the Institution / body etc. in English (if provided)
Abbreviation
Internet address
Austria
Bundesministeriumfiir
Federal Ministry of Economics
BMWA
http://www.bmwa.gv.at/BMWA/defaulthtm (in German)
Wirtschaft & Arbeit
and Labour
http://www.bmwa.gv.at/EN/default.htm (in Englsih)
Sektlon III - Arbeitsrecht
Department III - Labour Law and
http://www.bmwa.gv.at/BMW A/Ministerium/Organigramm/sektion3 .htm
und Arbeitsinspektion
Labour Inspectorates
(in German); http://www.bmwa.gv.at/EN/Ministry/Organisational/
Zeniral Arbeitsinspektorat
Central Labour Inspection
hltp://www.bmwa.gv.at/BMWA/Themen/Arbeitsrecht'Arbeitsinspektion/
sektion3.htm (in English) defeulthtm (in German); http://www.bmwa.gv.at/EN/Topics/ Labourkw/Inspection/defaulthtm (in English)
Belgium
Le Service public federal
SPF
In order to reach the website of the SPF, you have to first to the following
Emploi, Travail et
website of the ministry of employment
Concertatwn sociale
http://www.meta.fgov.bepa/paa/framesetrriOO/.htm and you have to click on the link for "le SPF" on the left hand column.
Direction generate
If you have reached the SPF website via the procedure described above,
Controle du bien-Stre au
look under the first heading (Le Service public fidiral Emploi, Travail et
travail
Concertatian sociale par administration) for the link to the Direction generate Controle du bien-etre QU travail
Division du controle des risques chimiques
On the website of the Direction generate Controle du bien-etre au travail you either click on the link for the link for the Division du contrdle des risques chimiques provided for on that page at the beginning or you scrol to section 3.
379
If not indicated otherwise, the links are only available in the language of the country
Name of the Institution / body etc. in English (if provided)
Abbreviation
Inspection du travail
Internet address
You find the link to the labour inspection on the SPF website (see above) under the first heading (Le Service public federal Emploi, Travail et Concertation sociale par administration, last bullet point.
Denmark
Besfaeftigelsesministeriets
Ministry of Employment
BM
Arbejdstilsynet
Working Environment Authority
AT/WEA
http://www.at.dk/sw5441.asp (in Danish)
Arbejdsmilj0instituttet
National Institute of Occupational
AMI/NIOS
http://www.ami.dk/Om%20AMI.aspx?lang=da (in Danish)
http://www.bm.dk/Default.asp (in Danish) http://www.bm.dk/english/default.asp (in Englsih) http://www.at.dk/swl2158.asp (in English)
Health ArbejdsmiIj0rSdet
The Working Environment
http://www.ami.dk/Om%2QAMI.aspx?Iang=en (in English) AMR
http://www.amr.dk/
STM
http://www.5tin.fi/Resource.phx/stm/lndex.htx (in Finnish)
Council
Finland
Sosiaali-ja
Ministry of Social Affairs and
terveysministerid
Health
Tydsuojeluosasto
Occupational Safety and Health
TySsuojelupiirit
http://www.stm.fi/Resource.phx/eng/index.htx (in English) TSO
http://www.stm.fi/Resource.phx/vastt/tvosi/tsosa/index.htx (in Finnish)
Department
http://www.stm.fi/RESource.phx/eng/subjt/safet/oshdepart.htx (in English)
Occupational Safety and Health
http://www.doshnet.fi/hallinto/deiault.htni fon Finnish)
Inspectorates Kemian
Advisory Committee for
tyosuojeluneuvottelukunta
Occupational health and safety on
Tydterveysiaitos
Finnish Institute of Occupational
http://www.doshnet.fi/hallinKi/english/piirit/Default.htm (in English)
KETSU
http://www.ketsu.net/
TTL/FIOS
httD://www.ttl.fi/internetj'suomi (in Finnish)
Chemical
France
Health
http://www.occuphealth.fi/inteimet/english (in English)
Ministerede I'Emploi, du
Ministry for Employment,
http://www.travail.gouv.fr/ (in French)
Travail et de la Cohesion
Labour and Social Cohesion
http://www.fcavafl.gouv.ft/english/index.htm (in English)
sociale
00
o
I
Beyond Limits
Name of the Institution / body etc. in the original language
380
Country
Country
Name of the Institution / body etc. in the original language
Name of the Institution / body etc. in English (if provided)
Abbreviation
Internet address
Direction des relations du
Labour Relations Branch
DRT
http://www.travail.gouv.fr/ministere/drt.html
Social Security Directorate
DSS
http://lesservices.servicepublic.fr/mod_res/m_fserv.htm?DN=ou%3DC120
travail Direction de la s^curite
l%2C+ou%3DA01%2C+ou%3Dcentrale%2C+ou%3Dstractures%2C+ou
sociale
%3Draf%2C+o%3Dgouv%2C+c%3DFR&P PREC=national3 Le Conseil Superieur de
Higher Council for the
la Prevention des Risques
Prevention of Occupational Risks
CSPRP
This council does not have its own website
Professionnels Institut National de
National Institute of Research
Recherche et Sdcurite
and Security
L "inspection du travail
Labour Inspectorate
Caisse nattonale de
National Health Insurance Fund
I'Assurance Maladie des
for Salaried Employees
INRS
http://www.inrs.fr/ (in French) http://en.inrs.rr/ (in English) http://www,drtefp-paysdelaloire.travail.gouv.fr/§io.htro
CNAMTS
http://www.ameli.fr/134/RUB/134/orrib.html
ANACT
http://www.anact.fr/webstatic/
BMWA
http://www.bmwa.bund.de/ (in German)
travailleurs salaries
Germany
Agence nationalepour
National Agency for the
I'amelioration des
Improvement of Working
Wirtschaft und Arbeit
Labour
Bundesanstaltfir
Federal Institute for Occupational
Arbeitsschutz und
Safety and Health
http://www.bmwa.bund.de/Navigation/Service/english.html (in English) BAuA/FIOSH
http://www.baua.de/index.htm (in German) http://www.baua.de/eindex.htm (in English)
AGS
http://www.baua.de/prax/ags/index.htm
BQ
http://www.hvbg.de/d/pages/index.html (in German)
381
Conditions Ministry of Economics and
Annex I
conditions de travail Bundesministeriumftir
Arbeitsmedizin Ausschuss jur Gefahrstoffe Berufsgenossenschaften
Institutions for statutory accident
Name of the Institution / body etc. in English (if provided)
Abbreviation
insurance and prevention
Internet address
http://www.hvbg.de/e/pages/index.html (in English)
Gewerbeaufsickts&mter
http://www.ni-d.de/Doc/gewauf.html
Landesamterfitr
http://lasi.osha.de/
Arbeitsschutz Senatskommissiem zur
Senate Commission on the
htrp://www.drg.de/di^im_jHofiystruldin'/grermen/senat/korrmrissionen_au
Prtifung
Investigation of Health Hazards
sschuesse/senatskommission_pruefungL_arbeitsstoffe/index.html(in
gesundheitsschfidlicher
of Chemical Compounds in the
German); nttp://www.dfg.de/en/dfg_profile/structure('statutory_
Arbeitsstoffe
Work Area
bodies/senate/senate_cammissions_and_committees/investigation_health_ hazards/index.html (in English)
Greece
Ministry of Labour and Social
http://www.labor-ministry.gr/
Affairs Ministry of Health and Welfare
http://www.ypyp.gr/
General Directorate of Working
http://www.ash.gr/index_gr.html
Conditions and Health Centre of Occupational Health
K.A.Y.E
hni)^/www.ypergka.gr/main.php?u=^o2Fload.php%3Fd%3D9
EL.IN.Y.A.E:
http://www.elinyae.gr/ (in Greek)
and Safety Centre for Diagnosis of Occupational Diseases Elliniko Instttuyto xgieinis
Hellenic Institute for
kai asfaleias tis Ergasias
Occupational Health and Safety Joint State Technical Inspectors
Ireland
Minister for Enterprise,
http://www.elinyae.gr/ENGLISH/elinyae.htm (in English) SEPE http://www.entemp.ie/
Trade and Employment Health and Safety Authority (HSA)
http://www.hsa.ie/publisher/index.jsp
I
Beyond Limits
Name of the Institution / body etc in the original language
382
Country
Country
Name of the Institution / body etc. in the original language
Name of the Institution / body etc. in English (if provided)
Abbreviation
Health and Safety
Internet address
only reachable via the HSA website
Authority's inspectorate
Italy
Ministero della Salute
The Ministry of Health
http://www.mirdsterosalute.it/
Ministero del Lavoro e
Ministry of Labour and Social
http://www.welfare.gov.it/default
delle Politiche Social!
Affairs
Istituto Superioreper la
The National Institute of
Prevenzione e la
Occupational Safety and Health
ISPESL
http^/www.ispesl.it/
The National Institute of Health
ISS
http://www.iss.itf
CCTN
Sicurezza del Lavoro Istituto Superiors di Sanita Cotnmissione consultiva
The National Advisory
tossicologica nazionale
Committee on Toxicology
Institute Nazionale per
The National Institute of
L 'Assicurazione contra gli
Insurance against Accidents at
Infortuni sul Lavoro
Work
Istituto Italiano di
The Italian Institute of Social
Medicma Saciale
Medicine
Commissione consultiva
The Permanent Advisory Committee for Accidents
prevenzione degli
Prevention and Occupational
infortuni e I'igiene del
Hygiene
http://www.inail.it/
IIMS
http://www.iims.it/
lavoro Labour Inspectorate
Ministere du Travail et du
Ministry for Labour and
http://www.carabMeri.iti'cittadino/informa2iord/tutela/lavoro/lavoro_main. htm
Luxembourg
http://www.mt.etatlu/
383
Ispettorato del Lavoro
Annex I
permanente per la
MAIL
Abbreviation
Internet address
Name of the Institution / body etc. in the original language
Name of the Institution / body etc. in English (if provided)
/ 'Emploi
Employment
L 'Inspection du Travail et
Labour Inspectorate
ITM
http://www,itm.etatlu/#sec_au_travail
Ministirw da Seguranca
Ministry of the Social Security,
MSSFC
http://www.mssfc.gov.pt/index.php?eorpo=english (in English)
Social, da Familia e da
Family and Child ISHST
http://www.idict.gov.pt/
CES
http://www.ces.pt/ (in Portuguese)
Crianga Institute} para a Seguranca, Higiene e Saude no Trabalho Conselha Ecanamico e
Economic and Social Council
http://www.ces.pt/html/e_main.htm (in Englsih)
Social Comissao Permanamte
Permanent Commission of Social
de Concertacao Social
Consultation
Inspeccao Oeral do
http://www.ces,pt/html/e_main.htm IGT
http://www.igt .idict.gov.pt/
MTAS
http://www.mtas.es/
CNSST
http://www.cgt.es/spcgta/Comision.htm
INSHT
http://www.mtas.es/insht/index.htm
Trabalho
Spain
Ministerio de Trabajo y Asuntos Sociales Commission Nadonal de Seguridady Salud en el Trabajo Institute Nadonal de Seguridad e Hugienen el Trabajo
http://www.mtas.es/insht/sistemas/inspec.htm
Inspection de Trabajo
Sweden
Ndringsdepartementet
Ministry of Industry,
http://www.regeiingen.se/8b/d/1470 (in Swedish)
Beyond Limits
I
des Mines
Portugal
384
Country
Couutry
Name of the Institution / body etc. in the original language
Name of the Institution / body etc. in English (if provided)
Abbreviation
Internet address
http://www.sweden.gov.Se/sb/d/2067 (in English)
Employment and Communication ArbetsmiljSverket
Work Environment Authority
Arbetslivsinstltutet
National Institute for Working
http://www.arbetslivsinstitutet.se/ (in Swedish)
Life
http://www.arbetslivsinstitutet.se/en/ (in English)
Ministerie van Soclale
Ministry of Social Affairs and
http://home.szw.nl/index/dspjindex.cfm (in Dutch)
Taken en
Employment
http://www.employment.gov.nl/ (in English)
AV/SWEA
http://www.av.se/ (in Swedish) http://www.av.se/english/aboutjus/ (in Englsih)
The Netherlands
Werkgelegenheid Directoraat-Generaal
DGAVIB
http://almanak.overheid.nl/WPSServkt?action=document&id=49352
Arbeidsverhoudingen en Internationale Betrekkingen De Gezondheidsruad
The Health Council of the
http://www.gr.nl/index.php ?phpLang=nl (in Dutch)
Netherlands Dutch Expert Committee on
http://www.gr.nl/index.php (in English) DBCOS
http://www.gr.nl/wgd.php
SEE.
http://www.ser jil/ (in Dutch)
Occupational Standards Sociaal Economische
Social and Economic Council
Raad Subcommittee on MAC values of
waarden (MAC)
the Social and Economic Council
Health and Safety
HSC Advisory Committee on
Executive
Toxic substances
http://www.ser.nl/overdeser/de&ult.asp?desc=comnrissies_10_5#2 HSE/HSC/ACTS
http://www..hse.gov.uk/aboutus/hac/iacs/acts
Annex I
United Kingdom
http://www.ser.nl/deiault,asp?desc=en index (in Englsih)
Subcommissie MAC-
385
386
Annex II
1. 1. Basic Directives 474 Directives474
78/610 Vinyl Chloride Monomer (05.01.80) repealed by 99/38
A B
DK D E FIN F GR IRL
476 75 N C 47