Eriksson / Gilek / Rudén Regulating Chemical Risks

European and Global Challenges
1. Auflage 2010
ISBN: 978-90-481-9428-5
Verlag: Springer Netherlands
Format: PDF
Kopierschutz: 1 - PDF Watermark

E-Book, Englisch, 350 Seiten

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.

Autoren/Hrsg.

Eriksson, Johan

Gilek, Michael

Rudén, Christina

Inhaltsverzeichnis

1;Preface;6
2;Contents;8
3;Contributors;10
4;Chapter 1: Introduction;14
5;Part I:Chemical Risk Assessment and RiskCommunication;19
5.1;Chapter 2: Risk Governance: Contemporary and Future Challenges;20
5.1.1;2.1 Challenges Posed by Seriousness, Complexity, Uncertainty, and Ambiguity;21
5.1.1.1;2.1.1 Seriousness;21
5.1.1.2;2.1.2 Complexity;21
5.1.1.3;2.1.3 Scientific Uncertainty;22
5.1.1.4;2.1.4 Interpretative and Normative Ambiguity;23
5.1.2;2.2 Conceptual Design of an Integrative Risk Governance Model;24
5.1.2.1;2.2.1 Pre-assessment;26
5.1.2.2;2.2.2 Risk Appraisal;27
5.1.2.3;2.2.3 Tolerability and Acceptability Judgment;28
5.1.2.4;2.2.4 Risk Management;30
5.1.2.5;2.2.5 Risk Communication;33
5.1.3;2.3 Conclusions;35
5.1.4;References;37
5.2;Chapter 3: Communicating Chemical Risks: Beyond the Risk Society;39
5.2.1;3.1 Introduction;39
5.2.2;3.2 Early Approaches to Researching Science and the Media;41
5.2.3;3.3 Which Risks Attract Attention, Why and Under What Conditions?;43
5.2.4;3.4 Risk Society;44
5.2.5;3.5 The Brent Spar;46
5.2.6;3.6 The Prestige Oil Disaster;48
5.2.7;3.7 Conclusion: Beyond the Risk Society;50
5.2.8;References;52
5.3;Chapter 4: Framing Chemical Risks in Sweden and Poland: Journalists’ Narratives and Media Texts;55
5.3.1;4.1 Introduction;55
5.3.2;4.2 Purpose;57
5.3.3;4.3 The Swedish and Polish Cases;57
5.3.4;4.4 Method and Materials;60
5.3.5;4.5 Results;63
5.3.6;4.5.1 Chemicals in the Swedish Press;63
5.3.7;4.5.2 Chemicals in the Polish Press;68
5.3.8;4.5.3 Swedish Journalists’ Narratives About Chemicals;71
5.3.9;4.5.4 Polish Journalists’ Narratives About Chemicals;73
5.3.10;4.6 Conclusions and Reflections;75
5.3.11;References;76
5.4;Chapter 5: REACH: What Has Been Achieved and What Needs To Be Done?;80
5.4.1;5.1 Introduction;80
5.4.2;5.2 Risk Management Criteria;81
5.4.3;5.3 Data Requirements in REACH;85
5.4.4;5.4 What Needs To Be Done;90
5.4.5;References;91
5.5;Chapter 6: Improving the Value of Standard Toxicity Test Data in REACH;93
5.5.1;6.1 Introduction;94
5.5.2;6.2 Suboptimal Testing Conditions;95
5.5.2.1;6.2.1 Background;95
5.5.2.2;6.2.2 Environmental Factors of Importance for Uptake and Effects;97
5.5.3;6.3 Population Modelling;99
5.5.3.1;6.3.1 Available Tools;99
5.5.3.2;6.3.2 Standard Test Data To Be Used for Regulatory Modelling;100
5.5.4;6.4 Suggestions for Improvements of REACH;102
5.5.5;6.5 Concluding Remarks;104
5.5.6;References;104
5.6;Chapter 7: Testing in Aquatic Ecotoxicology: What Are the Scientific Conditions for the ‘3R’ Concept?;107
5.6.1;7.1 Introduction;108
5.6.2;7.2 Why Fish Tests At All?;109
5.6.3;7.3 Alternative ‘3 R’ Based Approaches in Ecotoxicology;111
5.6.3.1;7.3.1 Reduction: Acute Threshold Approach;111
5.6.3.2;7.3.2 Replacement: In Vitro Cell Based Methods;112
5.6.3.2.1;7.3.2.1 Cytotoxicity;112
5.6.3.2.2;7.3.2.2 Sub-lethal and Mechanistic Endpoints;117
5.6.3.2.3;7.3.2.3 Bioconcentration and Bioaccumulation;118
5.6.3.3;7.3.3 Replacement: Fish Egg/Embryo Systems;118
5.6.4;7.4 Current Trends in Ecotoxicological Testing;122
5.6.5;7.5 Conclusion: Has the 3R’s Concept a Future in Ecotoxicology?;123
5.6.6;References;125
5.7;Chapter 8: Chemical Risk Assessment in Toxicological Perspective;128
5.7.1;8.1 Data Requirements for Hazard Assessment;129
5.7.1.1;8.1.1 Hazard Identification and Dose Response;129
5.7.1.2;8.1.2 Exposure Assessment;130
5.7.2;8.2 Risk Assessment;131
5.7.2.1;8.2.1 The General Approach;131
5.7.2.2;8.2.2 The Tools for Hazard Identification;132
5.7.2.2.1;8.2.2.1 Toxicokinetics;132
5.7.2.2.2;8.2.2.2 Omics;133
5.7.2.2.3;8.2.2.3 Mode Versus Mechanism of Action;133
5.7.2.3;8.2.3 Risk Assessment for Threshold Compounds;134
5.7.2.4;8.2.4 Risk Assessment for Non-threshold Genotoxic Carcinogens;134
5.7.3;8.3 Classification and Labelling of Carcinogens;135
5.7.4;8.4 Conclusion;136
5.7.5;References;137
5.8;Chapter 9: Occupational Exposure Limits in Comparative Perspective: Unity and Diversity Within the European Union;139
5.8.1;9.1 Introduction;139
5.8.2;9.2 European Community Involvement;140
5.8.3;9.3 Aiming for Unity;141
5.8.4;9.4 National Diversity;143
5.8.5;9.5 Scrutinising Diversity;147
5.8.6;9.6 Unity and Diversity;151
5.8.7;References;153
5.9;Chapter 10: Scientific Uncertainty and Science-Policy Interactions in the Risk Assessment of Hazardous Chemicals;157
5.9.1;10.1 Identifying Substances of High Concern;157
5.9.2;10.2 Uncertainty in Risk Assessments of Potential PBT/vPvB Substances;159
5.9.2.1;10.2.1 Uncertainties Identified in the Exposure Assessment;159
5.9.2.2;10.2.2 Uncertainties Identified in the Hazard Assessment;160
5.9.2.3;10.2.3 Uncertainties Identified in the Overall PBT Conclusions;161
5.9.3;10.3 Discussion;163
5.9.4;10.4 Conclusions and Recommendations;165
5.9.5;References;166
5.10;Chapter 11: Assessing Chemical Risks: Evaluating Products Rather than Substances, and the Case of Anti-fouling Paints;168
5.10.1;11.1 Introduction;168
5.10.2;11.2 Background: Anti-fouling Paints;170
5.10.2.1;11.2.1 History of Anti-fouling Paints Globally;170
5.10.2.2;11.2.2 History of Regulations in Sweden;171
5.10.2.3;11.2.3 The Situation of Today on Anti-fouling Paints in Sweden;172
5.10.3;11.3 The Biocidal Products Directive, REACH and Pitfalls;172
5.10.4;11.4 Experimental Results of Toxicity from Physically Working Paints;174
5.10.4.1;11.4.1 How Can Products Only Containing Basic Chemicals Be Toxic?;176
5.10.4.1.1;11.4.1.1 Effects of Regulations;176
5.10.4.1.2;11.4.1.2 Toxic Chemicals Added for Other Reasons Than Biocidal;177
5.10.4.1.3;11.4.1.3 Synergistic Effects;178
5.10.5;11.5 Classification of Substances and Labelling of Products;178
5.10.6;11.6 Conclusion;178
5.10.7;References;179
6;Part II:Chemical Regulation: Politics, Policy andManagement;182
6.1;Chapter 12: Global Trends in Chemicals Management;183
6.1.1;12.1 Drivers for International Cooperation in Chemical Safety;183
6.1.1.1;12.1.1 Developed Countries Lead Legislation and Its Implementation;184
6.1.1.2;12.1.2 Developing Countries Suffer the Worst Effects of Chemicals on Health;184
6.1.1.3;12.1.3 Chemicals Cross National Borders;185
6.1.1.4;12.1.4 Production and Use Move Towards Developing Countries;186
6.1.1.5;12.1.5 A Multitude of Chemicals May Harm Health and the Environment;186
6.1.1.6;12.1.6 Reducing Differences May Help Industry, Trade and Health;188
6.1.1.7;12.1.7 Chemical Safety Helps Overall Development;188
6.1.1.7.1;12.1.7.1 The Poor Are at Greatest Risk;189
6.1.1.7.2;12.1.7.2 Chemical Safety Has Links to Development Beyond Poverty Aspects;189
6.1.1.8;12.1.8 A Broad Range of Stakeholders Are Involved;190
6.1.1.9;12.1.9 Main Contentions: Protecting Industry vs. Funding for Developing Safety;190
6.1.2;12.2 Global Development of Chemical Safety;191
6.1.2.1;12.2.1 Excessively Comprehensive Cooperation?;191
6.1.2.1.1;12.2.1.1 Almost 100 International Agreements and Programs;191
6.1.2.1.2;12.2.1.2 Policy from the Highest International Level;192
6.1.2.1.3;12.2.1.3 Policy Instruments: Binding and Voluntary;192
6.1.2.2;12.2.2 International Coordination Is Extensive;193
6.1.2.2.1;12.2.2.1 Organisation for Economic Cooperation and Development (OECD);194
6.1.2.2.2;12.2.2.2 International Program on Chemical Safety (IPCS);194
6.1.2.2.3;12.2.2.3 The International Council of Chemical Associations (ICCA);194
6.1.2.2.4;12.2.2.4 Intergovernmental Forum on Chemical Safety (IFCS);195
6.1.2.2.5;12.2.2.5 Inter-Organisation Programme for the Sound Management of Chemicals (IOMC);195
6.1.2.2.6;12.2.2.6 The International POPs Elimination Network (IPEN);195
6.1.2.2.7;12.2.2.7 Strategic Approach to International Chemicals Management (SAICM);196
6.1.2.2.8;12.2.2.8 Coordination of Basel, Rotterdam and Stockholm Conventions;196
6.1.2.3;12.2.3 Domination by Developed Countries;197
6.1.2.3.1;12.2.3.1 Assessment of Risks;197
6.1.2.3.2;12.2.3.2 Harmonisation of Classification and Labelling;198
6.1.2.3.3;12.2.3.3 Information Exchange;199
6.1.2.4;12.2.3.4 Risk Reduction;200
6.1.2.5;12.2.3.5 Strengthening of National Capacities;202
6.1.2.6;12.2.3.6 Prevention of Illegal International Traffic;202
6.1.3;12.2.4 Developing Countries Start with the Most Hazardous Chemicals;202
6.1.3.1;12.2.4.1 The SAICM Contents and Implementation;203
6.1.3.2;12.2.4.2 National Profiles;204
6.1.3.3;12.2.4.3 National Action Plans;205
6.1.3.4;12.2.4.4 Chemical Safety and National Development Priorities;205
6.1.3.5;12.2.4.5 How To Build Capacity;206
6.1.4;12.3 The Future of Global Chemical Safety;207
6.1.4.1;12.3.1 Developed Countries Accomplish What They Started;207
6.1.4.2;12.3.2 Lagging Implementation, Few New Agreements, Calls for Coordination;208
6.1.4.3;12.3.3 Developing Countries Will Not Keep Up To Speed;208
6.1.4.4;12.3.4 New Approaches Needed To Meet Increasing Risks;209
6.1.4.4.1;12.3.4.1 A More Complex Chemical Safety Landscape Takes Time To Master;210
6.1.4.4.2;12.3.4.2 Controlling Total World Emissions To Be Below Natural Ones?;210
6.1.4.5;12.3.5 Control at the Source Instead of Cleaning Up Later;211
6.1.4.5.1;12.3.5.1 The Intake Fraction Links Release and Exposure;212
6.1.4.5.2;12.3.5.2 Equitable Responsibility for Releases Through Assigned Linearity;212
6.1.4.5.3;12.3.5.3 Screening Tools Can Elucidate the Need for Source Control;213
6.1.4.5.4;12.3.5.4 Paying for Unnecessary Emissions;214
6.1.4.5.5;12.3.5.5 Policy Developments Overdue;215
6.1.5;References;215
6.2;Chapter 13: Regulating Chemical Risk: REACH in a Global Governance Perspective;220
6.2.1;13.1 The Evolution of European Risk Regulation: The Road to REACH;220
6.2.1.1;13.1.1 Chemicals Control in the EU Before REACH;221
6.2.1.2;13.1.2 Why Reform?;222
6.2.1.3;13.1.3 Negotiating and Adopting REACH;224
6.2.2;13.2 REACH and the Transformation of Regulatory Decision-making;225
6.2.2.1;13.2.1 Privatisation of Chemical Control Responsibilities Under REACH;226
6.2.2.2;13.2.2 Centralising Regulatory Decision-making;227
6.2.2.3;13.2.3 Understanding the Transformation of Regulatory Decision-making;229
6.2.3;13.3 REACH as a Model for Global Risk Governance;231
6.2.3.1;13.3.1 Why Would Non-EU Countries Adopt REACH?;232
6.2.3.2;13.3.2 Globalisation Models;233
6.2.3.2.1;13.3.2.1 First Model: Full Assimilation;233
6.2.3.2.2;13.3.2.2 Second Model: Approximation of Rules;234
6.2.3.2.3;13.3.2.3 Global Risk Governance Considered;236
6.2.4;13.4 Conclusion;238
6.2.5;References;238
6.3;Chapter 14: The Precautionary Principle in EU and US Chemicals Policy: A Comparison of Industrial Chemicals Legislation;241
6.3.1;14.1 Chemicals and Complex Risks;241
6.3.2;14.2 Core Elements of the Precautionary Principle;242
6.3.3;14.3 The Precautionary Principle and EU Chemicals Policy;244
6.3.3.1;14.3.1 The Precautionary Principle in the EU;244
6.3.3.2;14.3.2 The Development of Chemicals Policy in the EU;245
6.3.3.3;14.3.3 The REACH Regulation;245
6.3.3.3.1;14.3.3.1 Registration (Title II);246
6.3.3.3.2;14.3.3.2 Evaluation (Title VI);247
6.3.3.3.3;14.3.3.3 Authorisation (Title VII);248
6.3.3.3.4;14.3.3.4 Restrictions (Title VIII);249
6.3.3.3.5;14.3.3.5 Other Central Elements of REACH;250
6.3.3.4;14.3.4 REACH and the Precautionary Principle;251
6.3.4;14.4 The Precautionary Principle in US Chemicals Policy;252
6.3.4.1;14.4.1 The Precautionary Principle in US Policies;253
6.3.4.2;14.4.2 History of Chemicals Law in the US;253
6.3.4.3;14.4.3 The Toxic Substances Control Act;254
6.3.4.3.1;14.4.3.1 Testing of Chemical Substances and Mixtures (Section 4);254
6.3.4.3.2;14.4.3.2 Manufacturing and Processing Notices (Section 5);255
6.3.4.3.3;14.4.3.3 Regulation of Hazardous Chemical Substances and Mixtures (Section 6);256
6.3.4.3.4;14.4.3.4 Reporting and Retention of Information (Section 8);257
6.3.4.3.5;14.4.3.5 Other Central Elements in TSCA;258
6.3.4.4;14.4.4 TSCA and the Precautionary Principle;258
6.3.5;14.5 Discussion;259
6.3.6;References;263
6.4;Chapter 15: Chemical Regulations in Central and Eastern Europe: The Pull of Transnational Markets and Associations;268
6.4.1;15.1 Introduction;269
6.4.2;15.2 The Market Logic of Harmonising Chemical Regulations;269
6.4.3;15.3 Industry Associations, Policy Coalitions, and Regulatory Diffusion;273
6.4.4;15.4 Corporatisation of Chemical Safety and Implications;279
6.4.5;15.5 Conclusion;281
6.4.6;References;281
6.5;Chapter 16: Capacity Building for Chemicals Control: Legislation, Institutions, Public–Private Relationships;283
6.5.1;16.1 Introduction;283
6.5.2;16.2 Background;284
6.5.2.1;16.2.1 Chemicals Control – An Internationally Prioritised Issue;284
6.5.2.2;16.2.2 Basic Elements of Chemicals Risk Management;285
6.5.3;16.3 Legislation on Product and Trade-orientated Risk Management;285
6.5.4;16.4 Rationale for Separate General Legislation on Chemicals;286
6.5.5;16.5 Design of Legislation on Chemicals;288
6.5.6;16.6 Responsibility of Enterprises;289
6.5.7;16.7 Capability and Capacity of Enterprises;291
6.5.7.1;16.7.1 Organisation and Expertise;291
6.5.7.2;16.7.2 Good Chemicals Control Promotes Business;292
6.5.8;16.8 Role of Public Institutions;292
6.5.9;16.9 NGOs;292
6.5.10;16.10 Capability and Capacity of Public Institutions;293
6.5.11;16.11 Organisation of Public Institutions;293
6.5.11.1;16.11.1 Policy Level;294
6.5.11.1.1;16.11.1.1 Allocation of Responsibilities at the Ministerial Level;294
6.5.11.1.2;16.11.1.2 Co-ordination of Institutions;295
6.5.11.2;16.11.2 Implementation and Management Level;295
6.5.11.3;16.11.3 Enforcement Level;296
6.5.11.3.1;16.11.3.1 Organisation of Supervision Is Vital;296
6.5.12;16.12 Mechanisms of Financing;297
6.5.12.1;16.12.1 Costs and Gains;297
6.5.12.1.1;16.12.1.1 Public Sector;297
6.5.12.1.2;16.12.1.2 Enterprises;298
6.5.12.1.3;16.12.1.3 Possible Alternatives for Financing Work of Public Institutions;298
6.5.13;16.13 Conclusion;299
6.5.14;References;300
6.6;Chapter 17: Scientific Committees and EU Policy: The Case of SCHER;301
6.6.1;17.1 Introduction;302
6.6.2;17.2 Perspectives on the Science–Policy Interface;303
6.6.3;17.3 Mandate and Composition of SCHER;304
6.6.4;17.4 The Working Process: Managing Facts and Values;308
6.6.5;17.5 Coping with External Pressure;312
6.6.6;17.6 The Political Role and Impact of SCHER;313
6.6.7;17.7 Conclusion;315
6.6.8;References;316
6.7;Chapter 18: Implementing Chemical Regulation: The Role of Inspectors;318
6.7.1;18.1 Introduction;318
6.7.2;18.2 The Swedish Chemicals Inspectorate and the Swedish Work Environment Authority and Their Inspectors;320
6.7.3;18.3 The Discretion of Inspectors;322
6.7.4;18.4 Vagueness in the Law (Regulations);324
6.7.5;18.5 Priorities of Inspection Themes and Objects;326
6.7.6;18.6 Compliance Strategies Used by Inspectors;330
6.7.7;18.7 Is Chemical Inspection an Effective Policy Instrument?;331
6.7.8;References;332
7;Part III:Conclusion;335
7.1;Chapter 19: Regulatory Futures in Retrospect;336
7.1.1;19.1 Regulatory Futures;336
7.1.2;19.2 The Future, As It Was;337
7.1.3;19.3 New Key Tensions in Chemical Regulations: Controversy;340
7.1.4;19.4 New Key Tensions in Chemical Regulations: Complexity;341
7.1.5;19.5 Conclusions;344
7.1.6;References;344
8;Index;346