Regulating Chemical Risks (eBook)

European and Global Challenges

Johan Eriksson, Michael Gilek, Christina Rudén (Herausgeber)

eBook Download: PDF

2010 | 2010
XII, 350 Seiten
Springer Netherland (Verlag)
978-90-481-9428-5 (ISBN)

Infos

This volume presents research on current trends in chemical regulations - a fa- growing, complex, and increasingly internationalized field. The book grew out from a multidisciplinary research project entitled 'Regulating Chemical Risks in the Baltic Sea Area: Science, Politics, and the Media', led by Michael Gilek at Södertörn University, Sweden. This research project involved scholars and experts from natural as well as social sciences, based at Södertörn University, Swedish Royal Institute of Technology (KTH), Karolinska Institutet, and Umeå University. The project group organized a multidisciplinary research conference on chemical risk regulations, held in Stockholm, August 15-17, 2007. Most of the contributions published in this book were, in draft form, first presented at this conference. The conference, like the ensuing edited volume, expanded the geographical focus beyond the Baltic Sea area to include wider European, and to some extent also global trends. Many thanks to all project colleagues and conference participants! We are very grateful for the generous financial support received from The Foundation for Baltic and East European Studies (Östersjöstiftelsen), The Swedish Research Council Formas, and from Södertörn University. Without this support the present book would not have been possible. Special thanks to all of our fellow contributors, all of whom have submitted to- cal papers based on high-quality research. Many thanks also to Tobias Evers, who assisted us with technical editing. Finally, we are grateful for the professionalism shown by our editors at Springer.

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This volume presents research on current trends in chemical regulations - a fa- growing, complex, and increasingly internationalized field. The book grew out from a multidisciplinary research project entitled 'Regulating Chemical Risks in the Baltic Sea Area: Science, Politics, and the Media', led by Michael Gilek at Sodertorn University, Sweden. This research project involved scholars and experts from natural as well as social sciences, based at Sodertorn University, Swedish Royal Institute of Technology (KTH), Karolinska Institutet, and Umea University. The project group organized a multidisciplinary research conference on chemical risk regulations, held in Stockholm, August 15-17, 2007. Most of the contributions published in this book were, in draft form, first presented at this conference. The conference, like the ensuing edited volume, expanded the geographical focus beyond the Baltic Sea area to include wider European, and to some extent also global trends. Many thanks to all project colleagues and conference participants! We are very grateful for the generous financial support received from The Foundation for Baltic and East European Studies (Ostersjostiftelsen), The Swedish Research Council Formas, and from Sodertorn University. Without this support the present book would not have been possible. Special thanks to all of our fellow contributors, all of whom have submitted to- cal papers based on high-quality research. Many thanks also to Tobias Evers, who assisted us with technical editing. Finally, we are grateful for the professionalism shown by our editors at Springer.

Inhalt

Preface 6
Contents 8
Contributors 10
Chapter 1: Introduction 14
Part I:Chemical Risk Assessment and RiskCommunication 19
Chapter 2: Risk Governance: Contemporary and Future Challenges 20
2.1 Challenges Posed by Seriousness, Complexity, Uncertainty, and Ambiguity 21
2.1.1 Seriousness 21
2.1.2 Complexity 21
2.1.3 Scientific Uncertainty 22
2.1.4 Interpretative and Normative Ambiguity 23
2.2 Conceptual Design of an Integrative Risk Governance Model 24
2.2.1 Pre-assessment 26
2.2.2 Risk Appraisal 27
2.2.3 Tolerability and Acceptability Judgment 28
2.2.4 Risk Management 30
2.2.5 Risk Communication 33
2.3 Conclusions 35
References 37
Chapter 3: Communicating Chemical Risks: Beyond the Risk Society 39
3.1 Introduction 39
3.2 Early Approaches to Researching Science and the Media 41
3.3 Which Risks Attract Attention, Why and Under What Conditions? 43
3.4 Risk Society 44
3.5 The Brent Spar 46
3.6 The Prestige Oil Disaster 48
3.7 Conclusion: Beyond the Risk Society 50
References 52
Chapter 4: Framing Chemical Risks in Sweden and Poland: Journalists’ Narratives and Media Texts 55
4.1 Introduction 55
4.2 Purpose 57
4.3 The Swedish and Polish Cases 57
4.4 Method and Materials 60
4.5 Results 63
4.5.1 Chemicals in the Swedish Press 63
4.5.2 Chemicals in the Polish Press 68
4.5.3 Swedish Journalists’ Narratives About Chemicals 71
4.5.4 Polish Journalists’ Narratives About Chemicals 73
4.6 Conclusions and Reflections 75
References 76
Chapter 5: REACH: What Has Been Achieved and What Needs To Be Done? 80
5.1 Introduction 80
5.2 Risk Management Criteria 81
5.3 Data Requirements in REACH 85
5.4 What Needs To Be Done 90
References 91
Chapter 6: Improving the Value of Standard Toxicity Test Data in REACH 93
6.1 Introduction 94
6.2 Suboptimal Testing Conditions 95
6.2.1 Background 95
6.2.2 Environmental Factors of Importance for Uptake and Effects 97
6.3 Population Modelling 99
6.3.1 Available Tools 99
6.3.2 Standard Test Data To Be Used for Regulatory Modelling 100
6.4 Suggestions for Improvements of REACH 102
6.5 Concluding Remarks 104
References 104
Chapter 7: Testing in Aquatic Ecotoxicology: What Are the Scientific Conditions for the ‘3R’ Concept? 107
7.1 Introduction 108
7.2 Why Fish Tests At All? 109
7.3 Alternative ‘3 R’ Based Approaches in Ecotoxicology 111
7.3.1 Reduction: Acute Threshold Approach 111
7.3.2 Replacement: In Vitro Cell Based Methods 112
7.3.2.1 Cytotoxicity 112
7.3.2.2 Sub-lethal and Mechanistic Endpoints 117
7.3.2.3 Bioconcentration and Bioaccumulation 118
7.3.3 Replacement: Fish Egg/Embryo Systems 118
7.4 Current Trends in Ecotoxicological Testing 122
7.5 Conclusion: Has the 3R’s Concept a Future in Ecotoxicology? 123
References 125
Chapter 8: Chemical Risk Assessment in Toxicological Perspective 128
8.1 Data Requirements for Hazard Assessment 129
8.1.1 Hazard Identification and Dose Response 129
8.1.2 Exposure Assessment 130
8.2 Risk Assessment 131
8.2.1 The General Approach 131
8.2.2 The Tools for Hazard Identification 132
8.2.2.1 Toxicokinetics 132
8.2.2.2 Omics 133
8.2.2.3 Mode Versus Mechanism of Action 133
8.2.3 Risk Assessment for Threshold Compounds 134
8.2.4 Risk Assessment for Non-threshold Genotoxic Carcinogens 134
8.3 Classification and Labelling of Carcinogens 135
8.4 Conclusion 136
References 137
Chapter 9: Occupational Exposure Limits in Comparative Perspective: Unity and Diversity Within the European Union 139
9.1 Introduction 139
9.2 European Community Involvement 140
9.3 Aiming for Unity 141
9.4 National Diversity 143
9.5 Scrutinising Diversity 147
9.6 Unity and Diversity 151
References 153
Chapter 10: Scientific Uncertainty and Science-Policy Interactions in the Risk Assessment of Hazardous Chemicals 157
10.1 Identifying Substances of High Concern 157
10.2 Uncertainty in Risk Assessments of Potential PBT/vPvB Substances 159
10.2.1 Uncertainties Identified in the Exposure Assessment 159
10.2.2 Uncertainties Identified in the Hazard Assessment 160
10.2.3 Uncertainties Identified in the Overall PBT Conclusions 161
10.3 Discussion 163
10.4 Conclusions and Recommendations 165
References 166
Chapter 11: Assessing Chemical Risks: Evaluating Products Rather than Substances, and the Case of Anti-fouling Paints 168
11.1 Introduction 168
11.2 Background: Anti-fouling Paints 170
11.2.1 History of Anti-fouling Paints Globally 170
11.2.2 History of Regulations in Sweden 171
11.2.3 The Situation of Today on Anti-fouling Paints in Sweden 172
11.3 The Biocidal Products Directive, REACH and Pitfalls 172
11.4 Experimental Results of Toxicity from Physically Working Paints 174
11.4.1 How Can Products Only Containing Basic Chemicals Be Toxic? 176
11.4.1.1 Effects of Regulations 176
11.4.1.2 Toxic Chemicals Added for Other Reasons Than Biocidal 177
11.4.1.3 Synergistic Effects 178
11.5 Classification of Substances and Labelling of Products 178
11.6 Conclusion 178
References 179
Part II:Chemical Regulation: Politics, Policy andManagement 182
Chapter 12: Global Trends in Chemicals Management 183
12.1 Drivers for International Cooperation in Chemical Safety 183
12.1.1 Developed Countries Lead Legislation and Its Implementation 184
12.1.2 Developing Countries Suffer the Worst Effects of Chemicals on Health 184
12.1.3 Chemicals Cross National Borders 185
12.1.4 Production and Use Move Towards Developing Countries 186
12.1.5 A Multitude of Chemicals May Harm Health and the Environment 186
12.1.6 Reducing Differences May Help Industry, Trade and Health 188
12.1.7 Chemical Safety Helps Overall Development 188
12.1.7.1 The Poor Are at Greatest Risk 189
12.1.7.2 Chemical Safety Has Links to Development Beyond Poverty Aspects 189
12.1.8 A Broad Range of Stakeholders Are Involved 190
12.1.9 Main Contentions: Protecting Industry vs. Funding for Developing Safety 190
12.2 Global Development of Chemical Safety 191
12.2.1 Excessively Comprehensive Cooperation? 191
12.2.1.1 Almost 100 International Agreements and Programs 191
12.2.1.2 Policy from the Highest International Level 192
12.2.1.3 Policy Instruments: Binding and Voluntary 192
12.2.2 International Coordination Is Extensive 193
12.2.2.1 Organisation for Economic Cooperation and Development (OECD) 194
12.2.2.2 International Program on Chemical Safety (IPCS) 194
12.2.2.3 The International Council of Chemical Associations (ICCA) 194
12.2.2.4 Intergovernmental Forum on Chemical Safety (IFCS) 195
12.2.2.5 Inter-Organisation Programme for the Sound Management of Chemicals (IOMC) 195
12.2.2.6 The International POPs Elimination Network (IPEN) 195
12.2.2.7 Strategic Approach to International Chemicals Management (SAICM) 196
12.2.2.8 Coordination of Basel, Rotterdam and Stockholm Conventions 196
12.2.3 Domination by Developed Countries 197
12.2.3.1 Assessment of Risks 197
12.2.3.2 Harmonisation of Classification and Labelling 198
12.2.3.3 Information Exchange 199
12.2.3.4 Risk Reduction 200
12.2.3.5 Strengthening of National Capacities 202
12.2.3.6 Prevention of Illegal International Traffic 202
12.2.4 Developing Countries Start with the Most Hazardous Chemicals 202
12.2.4.1 The SAICM Contents and Implementation 203
12.2.4.2 National Profiles 204
12.2.4.3 National Action Plans 205
12.2.4.4 Chemical Safety and National Development Priorities 205
12.2.4.5 How To Build Capacity 206
12.3 The Future of Global Chemical Safety 207
12.3.1 Developed Countries Accomplish What They Started 207
12.3.2 Lagging Implementation, Few New Agreements, Calls for Coordination 208
12.3.3 Developing Countries Will Not Keep Up To Speed 208
12.3.4 New Approaches Needed To Meet Increasing Risks 209
12.3.4.1 A More Complex Chemical Safety Landscape Takes Time To Master 210
12.3.4.2 Controlling Total World Emissions To Be Below Natural Ones? 210
12.3.5 Control at the Source Instead of Cleaning Up Later 211
12.3.5.1 The Intake Fraction Links Release and Exposure 212
12.3.5.2 Equitable Responsibility for Releases Through Assigned Linearity 212
12.3.5.3 Screening Tools Can Elucidate the Need for Source Control 213
12.3.5.4 Paying for Unnecessary Emissions 214
12.3.5.5 Policy Developments Overdue 215
References 215
Chapter 13: Regulating Chemical Risk: REACH in a Global Governance Perspective 220
13.1 The Evolution of European Risk Regulation: The Road to REACH 220
13.1.1 Chemicals Control in the EU Before REACH 221
13.1.2 Why Reform? 222
13.1.3 Negotiating and Adopting REACH 224
13.2 REACH and the Transformation of Regulatory Decision-making 225
13.2.1 Privatisation of Chemical Control Responsibilities Under REACH 226
13.2.2 Centralising Regulatory Decision-making 227
13.2.3 Understanding the Transformation of Regulatory Decision-making 229
13.3 REACH as a Model for Global Risk Governance 231
13.3.1 Why Would Non-EU Countries Adopt REACH? 232
13.3.2 Globalisation Models 233
13.3.2.1 First Model: Full Assimilation 233
13.3.2.2 Second Model: Approximation of Rules 234
13.3.2.3 Global Risk Governance Considered 236
13.4 Conclusion 238
References 238
Chapter 14: The Precautionary Principle in EU and US Chemicals Policy: A Comparison of Industrial Chemicals Legislation 241
14.1 Chemicals and Complex Risks 241
14.2 Core Elements of the Precautionary Principle 242
14.3 The Precautionary Principle and EU Chemicals Policy 244
14.3.1 The Precautionary Principle in the EU 244
14.3.2 The Development of Chemicals Policy in the EU 245
14.3.3 The REACH Regulation 245
14.3.3.1 Registration (Title II) 246
14.3.3.2 Evaluation (Title VI) 247
14.3.3.3 Authorisation (Title VII) 248
14.3.3.4 Restrictions (Title VIII) 249
14.3.3.5 Other Central Elements of REACH 250
14.3.4 REACH and the Precautionary Principle 251
14.4 The Precautionary Principle in US Chemicals Policy 252
14.4.1 The Precautionary Principle in US Policies 253
14.4.2 History of Chemicals Law in the US 253
14.4.3 The Toxic Substances Control Act 254
14.4.3.1 Testing of Chemical Substances and Mixtures (Section 4) 254
14.4.3.2 Manufacturing and Processing Notices (Section 5) 255
14.4.3.3 Regulation of Hazardous Chemical Substances and Mixtures (Section 6) 256
14.4.3.4 Reporting and Retention of Information (Section 8) 257
14.4.3.5 Other Central Elements in TSCA 258
14.4.4 TSCA and the Precautionary Principle 258
14.5 Discussion 259
References 263
Chapter 15: Chemical Regulations in Central and Eastern Europe: The Pull of Transnational Markets and Associations 268
15.1 Introduction 269
15.2 The Market Logic of Harmonising Chemical Regulations 269
15.3 Industry Associations, Policy Coalitions, and Regulatory Diffusion 273
15.4 Corporatisation of Chemical Safety and Implications 279
15.5 Conclusion 281
References 281
Chapter 16: Capacity Building for Chemicals Control: Legislation, Institutions, Public–Private Relationships 283
16.1 Introduction 283
16.2 Background 284
16.2.1 Chemicals Control – An Internationally Prioritised Issue 284
16.2.2 Basic Elements of Chemicals Risk Management 285
16.3 Legislation on Product and Trade-orientated Risk Management 285
16.4 Rationale for Separate General Legislation on Chemicals 286
16.5 Design of Legislation on Chemicals 288
16.6 Responsibility of Enterprises 289
16.7 Capability and Capacity of Enterprises 291
16.7.1 Organisation and Expertise 291
16.7.2 Good Chemicals Control Promotes Business 292
16.8 Role of Public Institutions 292
16.9 NGOs 292
16.10 Capability and Capacity of Public Institutions 293
16.11 Organisation of Public Institutions 293
16.11.1 Policy Level 294
16.11.1.1 Allocation of Responsibilities at the Ministerial Level 294
16.11.1.2 Co-ordination of Institutions 295
16.11.2 Implementation and Management Level 295
16.11.3 Enforcement Level 296
16.11.3.1 Organisation of Supervision Is Vital 296
16.12 Mechanisms of Financing 297
16.12.1 Costs and Gains 297
16.12.1.1 Public Sector 297
16.12.1.2 Enterprises 298
16.12.1.3 Possible Alternatives for Financing Work of Public Institutions 298
16.13 Conclusion 299
References 300
Chapter 17: Scientific Committees and EU Policy: The Case of SCHER 301
17.1 Introduction 302
17.2 Perspectives on the Science–Policy Interface 303
17.3 Mandate and Composition of SCHER 304
17.4 The Working Process: Managing Facts and Values 308
17.5 Coping with External Pressure 312
17.6 The Political Role and Impact of SCHER 313
17.7 Conclusion 315
References 316
Chapter 18: Implementing Chemical Regulation: The Role of Inspectors 318
18.1 Introduction 318
18.2 The Swedish Chemicals Inspectorate and the Swedish Work Environment Authority and Their Inspectors 320
18.3 The Discretion of Inspectors 322
18.4 Vagueness in the Law (Regulations) 324
18.5 Priorities of Inspection Themes and Objects 326
18.6 Compliance Strategies Used by Inspectors 330
18.7 Is Chemical Inspection an Effective Policy Instrument? 331
References 332
Part III:Conclusion 335
Chapter 19: Regulatory Futures in Retrospect 336
19.1 Regulatory Futures 336
19.2 The Future, As It Was 337
19.3 New Key Tensions in Chemical Regulations: Controversy 340
19.4 New Key Tensions in Chemical Regulations: Complexity 341
19.5 Conclusions 344
References 344
Index 346

Produkt-Details

• Erscheint lt. Verlag: 18.8.2010
• Zusatzinfo: XII, 350 p.
• Verlagsort: Dordrecht
• Sprache: englisch
• Themenwelt: Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
• Themenwelt: Naturwissenschaften ► Biologie ► Ökologie / Naturschutz
• Themenwelt: Naturwissenschaften ► Chemie
• Themenwelt: Recht / Steuern ► EU / Internationales Recht
• Themenwelt: Recht / Steuern ► Öffentliches Recht ► Umweltrecht
• Themenwelt: Sozialwissenschaften ► Politik / Verwaltung ► Politische Theorie
• Themenwelt: Sozialwissenschaften ► Soziologie
• Themenwelt: Technik ► Umwelttechnik / Biotechnologie
• Schlagworte: chemicals • ecotoxicology • EDU • Ems • GHS • Governance • REACH • Regulation • Risk
• ISBN-10: 90-481-9428-8 / 9048194288
• ISBN-13: 978-90-481-9428-5 / 9789048194285