Implementing the Precautionary Principle: Perspectives And Prospects

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Implementing the Precautionary Principle

Implementing the Precautionary Principle Perspectives and Prospects

Edited by

Elizabeth Fisher Corpus Christi College, University of Oxford, UK

Judith Jones The Australian National University, Canberra, Australia

René von Schomberg Directorate General for Research, European Commission

Edward Elgar Cheltenham, UK • Northampton, MA, USA

© Elizabeth Fisher, Judith Jones and René von Schomberg, 2006 All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical or photocopying, recording, or otherwise without the prior permission of the publisher. Published by Edward Elgar Publishing Limited Glensanda House Montpellier Parade Cheltenham Glos GL50 1UA UK Edward Elgar Publishing, Inc. 136 West Street Suite 202 Northampton Massachusetts 01060 USA

A catalogue record for this book is available from the British Library

ISBN-13: 978 1 84542 702 3 ISBN-10: 1 84542 702 5 Printed and bound in Great Britain by MPG Books Ltd, Bodmin, Cornwall

Contents List of figures List of tables List of boxes List of contributors Preface 1

vii viii ix xi xv

Implementing the precautionary principle: perspectives and prospects Elizabeth Fisher, Judith Jones and René von Schomberg

1

PART I GENERAL IMPLICATIONS OF THE PRECAUTIONARY PRINCIPLE FOR PUBLIC DECISION MAKING 2

The precautionary principle and its normative challenges René von Schomberg

3

The role of science and precaution in environmental and public health policy Joel Tickner and David Kriebel

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The precautionary principle and catastrophism on tenterhooks: lessons from a constitutional reform in France Olivier Godard

63

4

5

Precautionary policy assessment for sustainability Stephen Dovers

19

88

PART II THE CHALLENGES INVOLVED IN IMPLEMENTING THE PRECAUTIONARY PRINCIPLE 6

The precautionary principle and administrative constitutionalism: the development of frameworks for applying the precautionary principle Elizabeth Fisher and Ronnie Harding

v

113

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7

Contents

The burden and standard of proof in environmental regulation: the precautionary principle in an Australian administrative context Judith Jones and Simon Bronitt

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Tr(e)ading cautiously: precaution in WTO decision making Jan McDonald

9

The threshold test of the precautionary principle in Australian courts and tribunals: lessons for judicial review Warwick Gullett

10

Precautionary only in name? Tensions between precaution and risk assessment in the Australian GMO regulatory framework Jacqueline Peel

137 160

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PART III PROSPECTIVE APPLICATIONS OF THE PRECAUTIONARY PRINCIPLE IN SPECIFIC FIELDS 11

A long and winding road? Precaution from principle to practice in biodiversity conservation Rosie Cooney

223

12

Climate change and the precautionary principle Jeroen van der Sluijs and Wim Turkenburg

245

13

The tension between fiction and precaution in nanotechnology Arie Rip

270

14

A framework for the precautionary governance of food safety: integrating science and participation in the social appraisal of risk Andy Stirling, Ortwin Renn and Patrick van Zwanenberg

Index

284

316

Figures 4.1 Two concepts for the PP: early account of potential hazards versus more severe precautionary measures 6.1 Framework for applying the precautionary principle 6.2 Determining degrees of precaution 12.1 Risk evaluation diagram for different levels of global temperature change 14.1 Beyond risk: a series of further intractable ‘degrees of incertitude’ and examples 14.2 A general framework for the precautionary governance of food safety 14.3 The risk management escalator and stakeholder involvement (from simple via complex and uncertain to ambiguous phenomena)

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67 120 122 258 288 292

308

Tables 2.1 Deliberation levels involving the progressive invocation, application and implementation of the precautionary principle with its normative dimensions 2.2 Overview of state of affairs in science and the possible corresponding responses by risk management 2.3 Characteristics of regulatory systems 5.1 Principles of SEA 5.2 Hierarchical conceptualization of the precautionary principle relative to other approaches to decision and policy making in the face of uncertainty 6.1 Comparing the frameworks 7.1 Comparison between the core concepts of precaution and the elements of criminal burden of proof in criminal proceedings 12.1 Ice components of land ice and their sea level rise equivalents 14.1 Risk characteristics and their implications for risk management

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20 29 35 94

105 129

140 251 301

Boxes 2.1 Policy definition of the precautionary principle 2.2 Explanation of the terminology of the definition of the precautionary principle 4.1 The bias of a positive feedback of earliness on perceived severity of risks 4.2 The core of the Charter of the Environment incorporated into the French Constitution 14.1 Examples of ‘screening criteria’ that might be applied in food regulation 14.2 An example of the ‘presumption of prevention’ in food regulation 14.3 Examples of ‘precautionary appraisal’ in food regulation 14.4 An example of a ‘discursive process’ in food regulation

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37 37 69 74 295 296 299 300

Contributors Professor Simon Bronitt is the Director of the National Europe Centre and Professor in the Faculty of Law at the Australian National University. His research and teaching interests range across criminal law and procedure, and European and comparative law. He is one of the authors of a leading Australian criminal law textbook, Principles of Criminal Law (2nd edn, Lawbook Co, 2005), with B. McSherry. Dr Rosie Cooney coordinates an international collaborative initiative focused on the meaning and implementation of the precautionary principle in biodiversity conservation and natural resource management. It is a partnership of four international environment and sustainable development organizations: IUCN – The World Conservation Union, Fauna & Flora International, TRAFFIC and ResourceAfrica. Her major focus is on biodiversity conservation law and policy, particularly at the international level. She wrote The Precautionary Principle in Biodiversity Conservation and Natural Resource Management (IUCN, 2004) and co-edited Biodiversity and the Precautionary Principle: Risk and Uncertainty in Conservation and Sustainable Use (Earthscan, 2005). Professor Stephen Dovers is with the Centre for Resource and Environmental Studies, the Australian National University. Recent work includes the books Environment and Sustainability Policy: Creation, Implementation, Evaluation (Federation Press, 2005) and Institutional Change for Sustainable Development (with Robin Connor, Edward Elgar, 2004), and the coedited volumes New Dimensions in Ecological Economics (Edward Elgar, 2003), Strategic Environmental Assessment in Australasia (Federation Press, 2002), South Africa’s Environmental History (David Philip Publisher and Ohio University Press, 2002) and Ecology, Uncertainty and Policy (PrenticeHall, 2001). Dr Elizabeth Fisher is Fellow and Lecturer in Law, Corpus Christi College, University of Oxford. She has written numerous articles on the precautionary principle, risk and the law, and accountability. In 1999 she co-edited Perspectives on the Precautionary Principle (Federation Press) with Ronnie Harding. Professor Olivier Godard is Senior Researcher at the French Centre National de la Recherche Scientifique and Professor at Ecole Polytechnique, Paris. He xi

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has written extensively on environmental policies and sustainable development, including domestic waste management, climate change, emissions trading, scientific expertise, decision making under scientific controversy and the precautionary principle, to which he has dedicated more than a hundred articles. In 1997 he edited the first book in French on the precautionary principle, Le principe de précaution dans la conduite des affaires humaines (MSH-INRA), and co-edited Traité des nouveaux risques (Gallimard, 2002) with C. Henry, P. Lagadec and E. Michel-Kerjan. Dr Warwick Gullett is at the Centre for Maritime Policy, Faculty of Law, University of Wollongong in New South Wales, Australia. His research focuses on Australian and international fisheries law. He has published numerous articles in this area, as well as on marine protected areas, environmental impact assessment and the precautionary principle. He is Fisheries Law Editor for the Environmental and Planning Law Journal. Dr Ronnie Harding recently retired as Director of the Institute of Environmental Studies at the University of New South Wales. Among other roles she is currently an Assistant Commissioner with the New South Wales Natural Resources Commission. She is author (with Adrian Deville) of Applying the Precautionary Principle (Federation Press, 1997) and coeditor (with Liz Fisher) of Perspectives on the Precautionary Principle (Federation Press, 1999). Judith Jones (BSc (Syd), LLB (NSW)) is a Research Fellow at the National Europe Centre and Lecturer in Law at the Australian Centre for Environmental Law, Faculty of Law, the Australian National University. Her research interests centre on designing environmental regulation for decision making in the context of scientific uncertainty. She has numerous publications in the field of environmental law. Professor David Kriebel is Co-Director of the Lowell Center for Sustainable Production and full Professor in the Department of Work Environment, University of Massachusetts Lowell. His research as an epidemiologist covers several areas of occupational and environmental health. He was a member of the influential Institute of Medicine Committee on Agent Orange that identified links between the diseases in Vietnam veterans and exposure to herbicides. He has published widely on epidemiologic methods and exposure assessment. Professor Jan McDonald is with Griffith Law School, Queensland, Australia. She is the author of numerous articles on the linkages between international trade and environmental protection. Jacqueline Peel is a Senior Lecturer at the Faculty of Law, University of Melbourne. Jacqueline holds an LLM from New York University and

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returned to NYU as a Hauser Scholar at the Jean Monnet Center for Regional and International Economic Law and Justice in 2003–2004. Her research deals with international environmental law issues, with a particular focus on the relationship between law and science. She has recently published a book, The Precautionary Principle in Practice: Environmental Decision-making and Scientific Uncertainty (Federation Press, 2005). Professor Ortwin Renn is full Professor and Chair of Environmental Sociology of the State University in Stuttgart (Germany) and Director of the Interdisciplinary Research Unit on Risk, Governance and Sustainable Technology Development. Ortwin Renn is director of the non-profit company DIALOGIK, a research institute for the investigation of communication and participation processes in environmental policy making. He is a member of various national and international advisory councils and has received numerous awards including the Distinguished Achievement Award of the International Society for Risk Analysis (SRA). He is author of over 30 book publications and 250 articles in journals and edited volumes. Professor Arie Rip is Professor of Philosophy of Science and Technology, and a Director of the Centre for Studies of Science, Technology and Society at the University of Twente, The Netherlands. He works on science and technology dynamics, science policy, constructive technology assessment (TA), and the sociology of risk. He now directs a programme of studies on TA and social aspects of nanoscience and nanotechnologies, which is integrated in the Dutch research consortium NanNed. Dr Andy Stirling is at SPRU, science and technology policy research, at the University of Sussex. His research aims to address the policy challenges presented by scientific uncertainty, technological risk, the precautionary principle, participatory governance and transitions to more sustainable technologies. He has published widely in these areas and has served to these ends on a variety of UK and European policy advisory committees. Details of his work can be found at: http://www.sussex.ac.uk/spru/ profile7513. html. Dr Joel Tickner is Assistant Professor in the Department of Community Health and Sustainability at the University of Massachusetts Lowell where he is also a Principal Investigator at the Lowell Center for Sustainable Production. He has published numerous articles on the topics of pollution prevention, risk assessment, toxic chemicals policy, and uncertainty and the precautionary principle. Book publications include Protecting Public Health and the Environment: Implementing the Precautionary Principle (Island Press, 1999) (co-edited with C. Raffensperger) and he is editor of

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Contributors

the book Precaution, Environmental Science, and Preventive Public Policy (Island Press, 2003). Professor Wim Turkenburg is Professor at Utrecht University (The Netherlands). He is Scientific Director of the Copernicus Institute for Sustainable Development and Innovation and head of the department of Science, Technology and Society (STS) of Utrecht University. Also he is Scientific Director of the Utrecht Centre for Energy Research (UCE). He is the author of numerous publications. In 1996 he received the Greenman Award (MIT, Cambridge, MA) ‘to honor important contributions toward harnessing technology so that the human race can better live in harmony with the environment’. Dr Jeroen van der Sluijs is Senior Researcher and Assistant Professor at the Science Technology and Society division, Copernicus Institute for Sustainable Development and Innovation, Utrecht University, The Netherlands and Invited Professor at the Centre d’Economie et d’Ethique pour l’Environnement et le Développement, Université de Versailles Saint-Quentin-en-Yvelines, France. He is Rapporteur of the UNESCO COMEST Expert Group on the Precautionary Principle 2005. He has published numerous articles on multi-dimensional uncertainty methods, codes for good modelling practice, uncertainty communication and the precautionary principle. Patrick van Zwanenberg is a Research Fellow at SPRU, science and technology policy research, at the University of Sussex, working on issues of risk assessment and globalization in the food sector. Dr Dr phil. René von Schomberg is at the European Commission, Directorate General for Research. He is the author of numerous articles and monographs. Edited books in English include Science, Politics and Morality: Scientific Uncertainty and Decision Making (Kluwer, 1993), The Social Management of Genetic Engineering (Ashgate, 1998) (co-edited with Peter Wheale and Peter Glasner), Democratizing Technology (International Centre for Human and Public Affairs, 1999) and Discourse and Democracy. Essays on Habermas’s Between Facts and Norms (Suny Press, 2002) (co-edited with Kenneth Baynes).

Preface This book is a consequence of a convergence of thinking about precaution by each of the Editors, which occurred approximately a decade after the Rio Declaration launched the precautionary principle into global consciousness. Each of us was independently thinking about implementation and application of the principle and it was apparent that, in a variety of jurisdictions and contexts across the globe, there was an urgent need to examine this aspect of precaution. While debates continued to simmer on defining the principle and what it all meant, as a consequence of legal developments in each of the jurisdictions, we were turning our attention to what administrators and regulators were actually doing in response to the emerging legal obligations to apply the principle. In the European Union, environmental and public health policy is now based on the precautionary principle. The principle is now included in the EU food law and will be progressively applied to a growing number of EU policies. We were particularly interested to explore what the prospective implications are for a future application of the precautionary principle to emerging areas in the scientific and technological fields, such as biodiversity, climate change, (novel) food and nanotechnology. In Australia, the previous decade has witnessed two significant legal developments. In 1993, Justice Paul Stein of the Land and Environment Court had boldly read the precautionary principle into an existing statutory regime (Leatch v. National Parks and Wildlife Service (1993) 81 LGERA 270). This bold judicial move led to the principle playing an important role in environmental litigation, albeit often a contested one. At the same time there was an equally remarkable wave of legislative activity in Australian Federal and State/Territory parliaments, as policy makers sought to clarify the regulatory position regarding precaution in Australian environmental regulation. To reflect on the progress that had, at least in theory, been made in environmental regulation, Judith Jones convened a conference in 2003; The Precautionary Principle in Environmental Law: Ten Years Since Leatch (a conference supported by the Australian Centre for Environmental Law and the Centre for International and Public Law at the Faculty of Law, the Australian National University). This conference brought together a diverse group, including scholars, judges, policy makers and regulators to commence an exploration of implementation xv

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of precaution in Australia. Six of the chapters in this book evolved from papers presented at that conference. As well as researching the developments in these two jurisdictions Elizabeth Fisher was studying the legal and policy frameworks for standard setting under scientific uncertainty in a number of other countries and in particular the United States. Her research increasingly showed that while there were considerable differences in legal culture and thus legal doctrine and institutional structures and processes, there were also a number of common challenges. In particular, she found that the same issues were being raised in debate in different jurisdictions with the participants of those debates being oblivious to developments in other jurisdictions, or more seriously, taking those other developments out of context. Moreover, as her work crossed disciplinary boundaries, she increasingly saw that there were considerable divergences in how the challenges of implementation were characterized by policy makers and by lawyers. This is a fact that has been overlooked in much of the literature but is important in understanding the challenges in implementing the precautionary principle. Of course this book is not only a convergence of our thoughts about the precautionary principle but also those of the authors of the chapters in this collection. Many of these are also the product of ongoing discourses between those involved in this book and others and we feel honoured to have been able to carry out those conversations. We also thank the authors for the time and effort that they have put into their contributions. We do not see this book as putting an end to the debate about implementation. Rather we see it as the start. Elizabeth Fisher Judith Jones René von Schomberg Oxford, Canberra and Brussels

1. Implementing the precautionary principle: perspectives and prospects Elizabeth Fisher, Judith Jones and René von Schomberg In the last two decades the precautionary principle has become an established feature of environmental, public health and other risk regulation regimes in many different jurisdictions. It has been included in policy and law and given rise to a diverse body of decision-making practices (de Sadeleer 2002, Trouwborst 2002). The literature on the precautionary principle has grown exponentially alongside these developments. That scholarship and commentary is a rich and wide-ranging one and has included: general discussions of the principle (Freestone and Hey 1996, Harding and Fisher 1999, O’Riordan et al. 2001, Raffensperger and Tickner 1999); discussions about the legitimacy of the principle from a range of different disciplinary perspectives (Cross 1996, Morris 2000, Segal 1999, Treich 2001); reviews of its inclusion in law and policy (Christoforou 2002, de Sadeleer 2002, Scott and Vos 2002, Trouwborst 2002); discussions of its applications in specific circumstances (Gullett 2000, Gullett et al. 2001, Levidow 2001, Vos 2004, Walker 2003); and examinations of its implications for regulatory policy (Harremoës et al. 2002, Klinke and Renn 2002, Marchant and Mossman 2004, Stirling 2001, Wiener and Rogers 2002). While the literature on the principle is a large one, the challenges involved in its actual and potential application have tended to be underestimated. In particular, the messy business of integrating the principle into existing institutions and relating it to well-established decision-making processes has not received the attention it should have. Rather, the principle has tended to be dissected in an analytical vacuum, considered from a single disciplinary perspective, or treated in a ‘plug and play’ manner in that its implementation is characterized as simply requiring the inclusion of the principle into policy or a legislative scheme for it to be effective. The purpose of this collection of essays is to remedy this situation and in this book we have brought together some of the world’s top scholars on the precautionary principle to explore the complexities involved in its application. Their subject matters, modes of analysis and conclusions are 1

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Implementing the precautionary principle

very different, but one constant theme emerges from this collection, which is this. While there is no doubt that the precautionary principle is an established principle, there is an urgent need to think extensively and carefully about the circumstances in which the principle can be legitimately invoked and applied. Not only does it have implications for a wide range of decision-making institutions and processes, but in determining those implications there must be meticulous attention to how exactly the principle interrelates with existing decision-making norms and how it applies to a growing number of problem areas such as the environment, public health, food, agriculture, drugs and cosmetics, as well as how precautionary decision making in those areas interrelates with trade obligations (Button 2004, Scott and Vos 2002). In many ways the principle requires scholars and policy makers to be both visionaries and pedants. In this short introduction we first give an overview of the history of the precautionary principle. What is clear from that history is that the principle is both workable and legitimate. In the second section we examine how the chapters in this collection point to the need for scholars and policy makers to think more carefully and extensively about the process of implementation. In particular, we identify five different issues that need closer scrutiny. These are: the widespread institutional and policy implications of the principle; the multi-faceted process of application; the challenges created by specific risks; the important role for deliberation; and the three-way disjunction between scholarship, policy and practice. In identifying these issues we are not calling into question the legitimacy of the principle but rather highlighting that implementation brings with it a series of challenges that need to be taken into account in scholarship and policy making. In other words, the future success of the principle will depend on addressing these challenges.

THE RISE OF THE PRECAUTIONARY PRINCIPLE At its most basic, the precautionary principle is a principle of public decision making that requires decision makers in cases where there are ‘threats’ of environmental or health harm not to use ‘lack of full scientific certainty’ as a reason for not taking measures to prevent such harm. The simplicity of this statement should not lull the reader into thinking the principle lacks any philosophical depth – those depths are explored by a number of essays in this collection (Godard, chapter 4, von Schomberg, chapter 2) – but it is a useful place to start the discussion of the development of the principle. Conventional histories locate the precautionary principle’s birth as an explicit principle (Vorsorgeprinzip) in West German environmental policy of

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the late 1970s (Boehmer-Christiansen 1994, von Moltke 1988) although ‘precautionary-type’ policies clearly have a long history in many jurisdictions (Hamlin 1998, McGarity and Shapiro 1993) and theoretical traditions (Jonas 1984). In the 1980s the principle was included in a number of international agreements and began to have a high profile in international environmental law (Cameron and Abouchar 1991, Trouwborst 2002). In this context, the principle was perceived as being a means of stopping sovereign states from using lack of ‘full proof’ as a justification for their inaction and the principle was seen as particularly important in agreements such as the Ministerial Declaration on the Second International Conference of the Protection of the North Sea in 1987 and the Montreal Protocol on Substances that Delete the Ozone Layer (Hohmann 1994). In 1992 the principle was included in the Rio Declaration on Environment and Development (Principle 15) among the principles of general rights and obligations of national authorities at the UN Conference on Environment and Development (UNCED). At the same time it was adopted under the Convention of Biological Diversity and the Convention on Climate Change. This represented a turning point in its application. Its inclusion as a soft law principle (de Sadeleer 2002) not only gave the principle high-level legitimacy but also, due to the ‘think globally, act locally’ ideals of Agenda 21, a vehicle by which the principle was promoted in national jurisdictions (Commonwealth of Australia 1992, Department of the Environment 1990). With that said, the Rio Declaration was not the only reason for the principle’s sudden popularity in national and supranational jurisdictions in the 1990s. The principle and precautionary-type thinking were being developed independently in a number of jurisdictions, often as part of taking a more sophisticated approach to the problems of scientific uncertainty (Dovers and Handmer 1999, Wynne 1992). The principle was a sobering rejoinder to the overzealous promotion of ‘sound science’ in public policy (Fisher 2000, Porter 1995, Stirling 2001) and to decision makers putting heavy reliance on certain regulatory assumptions such as that of ‘assimilative capacity’ in relation to marine pollution (Stebbing 1992). Throughout the 1990s the precautionary principle was included in law and policy in a number of different jurisdictions, including the European Union (da Cruz Vilaca 2004), Australia (Fisher and Harding 2001), Canada (Abouchar 2002, Vanderzwaag 1999) and India,1 as well as most European states (de Sadeleer 2002). In some cases the principle was included in discrete regulatory schemes but in many cases it was construed as a broad guiding principle. Thus in Australia the principle was included in two important overarching policy documents – the National Strategy for Ecologically Sustainable Development and the Intergovernmental Agreement on the Environment (Fisher and Harding 2001). In the EU the principle was inserted into what

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is now Article 174(2) of the Treaty Establishing the European Community as one of four principles that Community policy on the environment ‘shall be based on’. Due to the operation of the integration principle in Article 6 of that same Treaty, the principle is now found to apply to all policies of the EU.2 In all these jurisdictions, many different actors have been involved in the principle’s application and the mode of implementation has often been a mixture of legislative reform, policy development and ad hoc litigation. It is now common practice in many jurisdictions for decisions to be made pursuant to the precautionary principle and public decision makers have considerable experience with applying it. Likewise, the case law relating to the principle is a large one, much of its subject matter being when and how public decision makers should apply the principle (Fisher 2001, Gullett, this book, chapter 9, Gullett et al. 2001, Vos 2004). Furthermore, the principle has also given rise to a debate about what are appropriate regulatory strategies in cases of scientific uncertainty (Raffensperger and Tickner 1999, Renn et al. 2003). The examples of the precautionary principle in operation are numerous and include examples in the field of mobile phone regulation (Independent Expert Group on Mobile Phones 2000); fisheries (Commission of the European Communities 2000a, Gullett et al. 2001); impact assessment (Gullett 2000); biotechnology regulation (Levidow 2001, Peel, this book, chapter 10); food safety (Commission of the European Communities 2000c, Stirling et al., this book, chapter 14); and the regulation of animal foodstuffs.3 The principle has continued to have a role to play in international environmental law, particularly in relation to the protection of the commons (Backes and Verschuuren 1998, Scott 2001).4 More significantly, the principle has increasingly become the focus of transnational trade disputes where states have relied on it in derogating from their international trade obligations (Bohanes 2002, McDonald, this book, chapter 8, Winickoff et al. 2005). It has been discussed in a number of rulings of the World Trade Organization (WTO)’s Dispute Appellate Body,5 has been the subject of debate in ongoing WTO discussions, and has received increased attention by international standard-setting bodies such as the Codex Alimentarius. In 2000 the principle was also adopted under the Cartagena Protocol for Biosafety, which not only gave it considerable legal force, but also set up a mutually supportive relationship between trade law and international environmental law (Schomberg 2000). What is clear from this history is that the precautionary principle is a legitimate principle that can be operationalized. Its legitimacy, its ‘worthiness to be recognised’ (Habermas 1984), can be seen in the fact that it has been embraced by countless mainstream actors in numerous jurisdictions. The principle is not the product of one culture, one agenda or one


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ideology. Its promotion has been because it is a sound principle of public decision making and its practical success can be seen in the fact that the principle has been implemented in many different legal cultures and the end result has been a large body of practice and discourse (Fisher 2002). The inclusion of the principle has not been an exercise in mere symbolism. Yet despite the growing popularity and entrenchment of the principle, it has not been without its critics. Many of those criticisms have been rehearsed in other places in the literature (Sunstein 2005) and while we have no room here to enter into a detailed discussion of those criticisms it is useful to highlight three common criticisms and their counterarguments to give some feeling about the state of the literature. In particular we would argue that much of the criticism has tended to be overly simplistic and ignored the reality of precautionary practices. First, there are those, particularly from industry, who argue that the principle is always a no-risk and non-science based principle (Brunton 1994, Sunstein 2005, Wirthlin World-wide 2000). In practice, however, decision makers relying on the precautionary principle have actually paid more attention to science and considered a wider array of possible regulatory responses (Commission of the European Communities 2000b, Stirling 1999, Tickner and Kriebel, this book, chapter 3). Thus for example, the EU sees science as an important and legitimate factor in the decision-making process.6 Second, there are those that argue that the principle does not provide clear guidance to decision makers (Cross 1996) and that this fact, along with the many different formulations of it, point to its lack of internal coherence (Stone 2001). This is an argument that blindly ignores the principle’s legal status as a legal principle (and that it is thus inherently flexible) as well as the influence of legal culture (and thus suggests that the authors do not know the basic principles of comparative law methodology) (Dworkin 1977, Fisher 2002, Kahn-Freund 1974). Finally, there are those that fear that the principle is a means of justifying arbitrary action or ulterior motives because decision makers do not need to rely on the ‘facts’ for making decisions (Majone 2002, Marchant and Mossman 2004). Such an assertion, however, overlooks the reality that in circumstances of scientific uncertainty, what is an ‘arbitrary decision’ is open to question, and relying on the ‘facts’ in such circumstances is profoundly problematic (Fisher and Harding, this book, chapter 6, Harremoës et al. 2002). In saying that much of the criticism of the precautionary principle is wrong-headed, we are not saying that the principle does not need to be carefully thought about or that there are not real challenges involved in its implementation. Rather, we are saying that criticism of the principle has tended to be directed at the issue of whether the principle is either workable and/or legitimate when it is obvious from surveying law and policy in

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many different jurisdictions that it is both. In other words, critical discourse about the principle has tended to treat it in prospective terms as something that could be implemented into regulatory regimes rather than what it is – a well-worked and much-applied principle. This is not only true of critics but for others writing about the principle as well, and there has often been a failure to engage fully with all the challenges involved in implementation. The principle has either been described from one disciplinary standpoint or has been treated as a simple exercise of including it in legislation or policy. Likewise, there have been few empirical studies of the principle in operation. The challenges created by legal culture, regulatory culture and sociopolitical culture have also been largely ignored and the operation of the precautionary principle has often been analysed as a series of outcomes (Fisher 2002).

THE CHALLENGES INVOLVED IN IMPLEMENTATION The essays in this collection go some way in remedying this deficiency in the literature by exploring a range of issues involved in the implementation of the principle. We do recognize that the principle and its application will continue to be contentious, and this can be seen in the fact that a number of essays in this book come to different conclusions. However, even where there is disagreement about some fundamental issues and problems, we feel it is still possible to: study the implementation of something that is difficult to define; accept its legitimacy from its overwhelming presence and prevalence; and examine what makes it workable in all its complexities by studying it in action. The authors, all leading experts on the precautionary principle, come from a wide array of backgrounds, both from the academy and from the world of policy making, as well as a range of legal and socio-political cultures. We invited the authors of this volume to write about what they saw as significant issues involved in implementing the principle or its possible application to future areas of policy. Some authors have evaluated and reflected on the way that the principle has been implemented so far in different national, supranational and international regimes (Fisher and Harding, chapter 6, McDonald, chapter 8, Peel, chapter 10). Others have used the past history of the principle as a starting point for considering the prospects for its future application either as a general principle (von Schomberg, chapter 2) or in relation to a specific field of application (Rip, chapter 13, van der Sluijs and Turkenburg, chapter 12). The end result is a diverse and multifaceted collection of essays that cover a wide array of


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topics and legal and socio-political cultures. In structuring this book we have divided the essays into three broad categories (although we appreciate that these categories overlap). In Part I are essays concerned with the general implications of the precautionary principle for decision making, including its implications for public decision-making practices (von Schomberg, chapter 2); its implications for regulatory science (Tickner and Kriebel, chapter 3); its conceptual nature and the implications of giving it constitutional status (Godard, chapter 4); and the need to think about its role in policy assessment (Dovers, chapter 5). In Part II we have included essays which consider the application of the principle in particular institutional contexts. Two of these essays consider the interface between the principle and established features of the institutional structures in which it is being implemented. Fisher and Harding discuss the interrelationship between general frameworks for applying the precautionary principle and administrative constitutionalism (chapter 6) and Jones and Bronitt examine the role that burdens and standards of proof play in administrative decision making (chapter 7). Other essays consider a more specific set of legal and policy developments. Thus McDonald explores the different ways in which WTO decision making takes the precautionary principle into account (chapter 8), Gullett examines some of the complex issues that arise around the threshold test for precaution for reviewing courts and tribunals (chapter 9), and Peel discusses the difficulties of inserting the principle into regulatory regimes without considering its broader implications (chapter 10). The essays in Part III explore the principle in relation to specific environmental and public health problems and illustrate in each case that there are a whole host of issues to consider. Cooney considers the implications of the principles for biodiversity conservation (chapter 11) and van der Sluijs and Turkenburg examine the uncertainties, and thus the role of the precautionary principle, in relation to climate change (chapter 12). Rip analyses the potential role of the principle in the emerging area of nanotechnology regulation (chapter 13) and Stirling, Renn and van Zwanenberg use food safety regulation as a starting point for reflecting on what form precautionary regulation should take (chapter 14). As a collection these essays represent more a research agenda than an exhaustive account of all the issues involved in the principle’s implementation, but in being such food for thought we hope they stimulate debate and reorient research and scholarship. Each essay raises a range of issues, and while there is no room here to summarize all of them it is useful to identify five key and interrelated themes which we see emerging from many of the pieces in this book. The first theme is that the implementation of the precautionary principle has widespread implications for decision-making institutions and

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processes. As the literature on the principle has shown, properly implementing the precautionary principle is not just a case of inserting it into law or policy but rather requires adjustments to institutional capacities and processes particularly in relation to deliberation (Fisher and Harding 1999, Stirling 2003). Thus for example, von Schomberg examines the way in which the principle will serve as a basis for deliberation at different decisionmaking levels and how it contrasts with ‘conventional’ modes of risk regulation (chapter 2). Stirling, Renn and van Zwanenberg argue the need to rethink how standard setting and risk appraisal processes are designed so as to take better into account different types of uncertainties and other features of food safety problems (chapter 14). Fisher and Harding argue that the implementation of the precautionary principle will, by necessity, require consideration of what is legitimate public administration, or in other words administrative constitutionalism (chapter 6). Dovers points to the need to think about the principle not only in terms of standard setting or the making of individual decisions but also in the development of policy (chapter 5). Tickner and Kriebel point to the need to think carefully about the role of science in decision making (chapter 3). Moreover, Peel illustrates the problems that arise when the principle is simply included into a regulatory regime without regard to these other issues (chapter 10). While the need to think about the widespread implications of the principle’s application may seem obvious, it has been one that has been largely overlooked in the literature and the principle has often been analysed almost as if it was an analytical riddle (Stewart 2002, Sunstein 2005), rather than a principle of public decision making which by necessity must result in an adjustment to decision-making institutions and processes. The second theme that emerges from this book is that scholars and policy makers must also think carefully about the actual technicalities of implementation and how the principle interrelates with features of the existing institutional landscape. This will often require a reflection on conventional understandings of the principle. Thus for example it is often described as a ‘shifting of the burden of proof’ or an adjustment to the ‘standard of proof’, but as Jones and Bronitt illustrate, this is by no means straightforward in the administrative context. Their piece forces scholars and policy makers to think what is meant by these terms and whether they are helpful in thinking about the principle (chapter 7). Likewise, Godard shows how there needs to be a more careful reflection on the type of arguments that are used to support and attack the precautionary principle (chapter 4). Other essays highlight the need to think in more detail about the issues that might be raised as part of implementation. Thus for example, Gullett examines those judicial and merits review cases where it is argued that decision makers have not properly applied the principle because the threshold


9

for its operation has not been triggered (chapter 9). McDonald casts a careful eye over WTO law to show that the implications of the principle are not only limited to its specific application (chapter 8). Tickner and Kriebel highlight the influence of existing regulatory regimes in the United States (chapter 3), Peel shows that legislative reform must be careful and well thought through (chapter 10), and Fisher and Harding argue that the development of frameworks is not just about the writing of practical checklists but requires an engagement with more general debates about good administration (chapter 6). Moreover, it is also clear that many of these authors are writing in terms of different legal and regulatory cultures (Fisher 2002). Gullett (chapter 9) and Jones and Bronitt (chapter 7) are engaging with many of the complexities of Australian administrative law while McDonald (chapter 8) is considering carefully a number of important features of the WTO regime. Likewise, those writing from the European perspective are characterizing the principle in terms of ‘risk’ (Stirling et al., chapter 14, von Schomberg, chapter 2) while in Australia the principle is thought of more in terms of natural resource management (Dovers, chapter 5, Gullett, chapter 9). The third theme that can be seen across this collection of essays is that there is a need to recognize that particular environmental and public health problems will create specific challenges for the implementation of the precautionary principle. Most obviously, this is due to the fact that different problems will involve different scientific uncertainties. Thus for example, Rip highlights that an emerging technology such as nanotechnology raises problems of ignorance in that we don’t know what we don’t know (chapter 13; see also Wynne 1992). In contrast van der Sluijs and Turkenburg consider the challenges that climate change creates for decision makers because of open ended systems and the uncertainties around the likelihood of large scale impacts (chapter 12). The need to think about the type of problems being regulated is not only because the scientific uncertainties involved will vary from problem to problem but also because other features of those problems will affect the decision-making process. Thus for example, Stirling, Renn and van Zwanenberg in their chapter argue the need to adapt decision-making processes in the light of not only different types of scientific uncertainty but whether a risk is also complex and/or sociopolitically ambiguous (chapter 14; see also Klinke and Renn 2002). The importance of this interrelationship between scientific uncertainty and other features of a problem can be seen in a number of the chapters. Thus for example Cooney identifies the problems of cross-sectoral activities in relation to biodiversity management (chapter 11) and the type of case law that Gullett discusses arises because of the high economic stakes involved in fisheries (chapter 9).

10


The fourth theme that emerges from this collection is that of deliberation, and a number of authors in this book make a close connection between the application of the precautionary principle and deliberative practices (Fisher and Harding, chapter 6, Stirling et al., chapter 14, von Schomberg, chapter 2). Deliberation goes beyond the meaning of simple discussions concerning a particular subject matter, and in its broadest meaning can be understood as ‘free and public reasoning among equals’ (Cohen 1996). Deliberation necessarily involves both public and individual dimensions and assumes the constraint of the principle of equality of participants to such deliberations, thereby contributing both to individual and to public autonomy of the citizen (Habermas 1996). Deliberation is concerned with the weighing of pro and contra arguments in relation to particular choices, options and measures of public concern with a view to decision making. However, deliberation does not only relate to concrete decision-making processes within the institutions of our formal democracy (for example, parliament), but also takes place at a certain distance from those formal decision-making bodies within civil society at large. Focusing on the relationship between deliberation and the precautionary principle thus requires scholars and policy makers to pay closer attention to the type of communication involved in particular participatory processes rather than taking them at face value. It also requires consideration of the type of institutional forums in which deliberation takes place (Stirling et al., chapter 14, von Schomberg, chapter 2). Likewise, a number of essays in this collection come to different conclusions about deliberation. Von Schomberg argues that the legitimacy of the invocation of the principle will be dependent on the way it is integrated in the context of deliberative democracy (chapter 2; see also Habermas 1996). As such, a constitutional basis of the precautionary principle is important in facilitating deliberation, involving public authorities and citizens in the policy-making process to ensure high qualitative and legitimate outcomes. In contrast, Fisher and Harding see deliberation having more a role to play in problem solving than in having a democratic dimension and thus argue that deliberation needs to be thought of in administrative terms (chapter 6; see also Steele 2001). The final broad theme that can be seen to emerge from this collection is that there is a need to recognize that there is often a disjunction between scholarship, policy and practice. What we mean by this is that the normative ideals of the scholar, the words of policy and law, and the actual practice of precautionary decision making may be difficult to reconcile with each other. This is highlighted by a number of authors (Cooney, chapter 11, Fisher and Harding, chapter 6, Stirling et al.,


11

chapter 14) and it is not just a case of practice falling short of ideals (Fisher 1999, Gullett 2000) but rather reflects the fact that, as seen above, the interface between the precautionary principle and its institutional and policy context is a complex one. The precautionary principle is always being applied in a context in which there are existing institutions, legal doctrines, policies, rules, and norms of decision making that will, alongside the precautionary principle, also regulate decision making (Jones and Bronitt, chapter 7; see also Fisher 2005). This can often result in the creation of often ad hoc regimes that do not provide a coherent guide to decision makers (Peel, chapter 10) or in implementation being influenced by a set of issues separate from the precautionary principle (Fisher and Harding, chapter 6). There are also many different actors involved in its application and this can often result in its implementation being shaped by debate and litigation, particularly in cases where there is a perception that it will restrict economic activity (Godard, chapter 4, Gullett, chapter 9). In recognizing all of this we are not being pessimistic about the potential for the principle’s application – the disjunction between theory, law and practice is a constant feature of all regulation (Hawkins 2002). Rather we are arguing that there is a need for far more empirical study into how the principle is implemented. Such studies could be guided by the types of themes identified above.

CONCLUSION In forcing public decision makers to think carefully about the scientific uncertainties involved in health and environmental decision making, the precautionary principle is perhaps one of the most significant principles of the contemporary era. It is no surprise that its rise has been so dramatic and that it has quickly become entrenched into regulatory regimes. What is important now for scholars and policy makers alike is to identify the challenges involved in the principle’s entrenchment and implementation and reflect on the precautionary principle in the light of them. We are confident that the essays in this book are a good starting point for this to occur.

NOTES 1. See Vellore Citizens Welfare Forum v. Union of India 9 Journal of Environmental Law 387 and AP Pollution Control Board v. Nayudu 1999 (1) UJ (SC) 426. 2. See Case T-74/00 Artegodan GmbH v. Commission [2002] ECR II-4965. 3. Case T-70/99 Alpharma v. Council [2002] ECR II-3495.

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4. See International Tribunal for the Law of the Sea: Southern Bluefish Tuna Cases (New Zealand v. Japan; Australia v. Japan) (Provisional Measures) (1999) 38 International Legal Materials 1624. 5. Appellate Body Report, European Communities – Measures Concerning Meat and Meat Products (Hormones), 16 January 1998, WT/DS26/AB; Appellate Body Report, Japan – Measures Affecting the Importation of Apples, 26 November 2003, WT/DS245/AB/R. 6. European Communities (2003), Regulation (EC) 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, Official Journal of the European Union, L268/1, 18 October 2003, paragraph 32 of the preamble.

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Hawkins, K. (2002), Law as Last Resort: Prosecution Decision-Making in a Regulatory Agency, Oxford: Oxford University Press. Hohmann, H. (1994), Precautionary Legal Duties and Principles of Modern International Environmental Law: The Precautionary Principle: International Environmental Law Between Exploitation and Protection, London: Graham & Trotman/Martinus Nijhoff. Independent Expert Group on Mobile Phones (2000), Mobile Phones and Health, London. Jonas, H. (1984), The Imperative of Responsibility: In Search for an Ethics of the Technological Age, Chicago: University of Chicago Press. Kahn-Freund, O. (1974), ‘On use and misuse of comparative law’, Modern Law Review, 37, 1–27. Klinke, A. and O. Renn (2002), ‘A new approach to risk evaluation and management: risk-based, precaution based, and discourse based strategies’, Risk Analysis, 22, 1071–94. Levidow, L. (2001), ‘Precautionary uncertainty: regulating GM crops in Europe’, Social Studies of Science, 31, 842–74. Majone, G. (2002), ‘What price safety? The precautionary principle and its policy implications’, Journal of Common Market Studies, 40, 89–109. Marchant, G. and K. Mossman (2004), Arbitrary and Capricious: The Precautionary Principle in the European Union Courts, Washington, DC: The AEI Press. McGarity, T. and S. Shapiro (1993), Workers At Risk: The Failed Promise of the Occupational Safety and Health Administration, New York: Praeger. Morris, J. (ed.) (2000), Rethinking Risk and the Precautionary Principle, Oxford: Butterworth-Heinemann. O’Riordan, T., J. Cameron and A. Jordan (eds) (2001), Reinterpreting the Precautionary Principle, London: Cameron May. Porter, T. (1995), Trust in Numbers: The Pursuit of Objectivity in Science and Public Life, Princeton: Princeton University Press. Raffensperger, C. and J. Tickner (1999), Protecting Public Health and the Environment: Implementing the Precautionary Principle, Washington, DC: Island Press. Renn, O., M. Dreyer, A. Klinke, C. Losert, A. Stirling, P. van Zwanenberg, U. Muller-Herold, M. Morosini and E. Fisher (2003), The Application of the Precautionary Principle in the European Union: Regulatory Strategies and Research Needs to Compose and Specify a European Policy on the Application of the Precautionary Principle (PrecauPri), Stuttgart: Centre for Technology Assessment, May, available at http://www.sussex.ac.uk/spru/environment/precaupripdfs.html. Schomberg, R. von (2000), ‘Agricultural biotechnology in the trade-environment interface: Counterbalancing adverse effects of globalisation’, in D. Barben and G. Abels (eds), Biotechnologie – Globalisierung-Demokratie, Berlin: Edition Sigma, pp. 111–31. Scott, J. and E. Vos (2002), ‘The juridification of uncertainty: observations on the ambivalence of the precautionary principle within the EU and WTO’, in C. Joerges and R. Dehousse (eds), Good Governance in Europe’s Integrated Market, Oxford: Oxford University Press, pp. 253–86. Scott, S. (2001), ‘How cautious is precautious? Antarctic tourism and the precautionary principle’, International and Comparative Law Quarterly, 50, 964–71.


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Segal, J. (1999), ‘An industry perspective on the precautionary principle’, in R. Harding and E. Fisher (eds), Perspectives on the Precautionary Principle, Sydney: Federation Press, pp. 73–82. Stebbing, A. (1992), ‘Environmental capacity and the precautionary principle’, Marine Pollution Bulletin, 24, 287–95. Steele, J. (2001), ‘Participation and deliberation in environmental law: a problem solving approach’, Oxford Journal of Legal Studies, 21, 415–42. Stewart, R. (2002), ‘Environmental regulation under uncertainty’, Research in Law & Economics, 10, 71–126. Stirling, A. (1999), On Science and Precaution in the Management of Technological Risk, Luxembourg: European Science and Technology Observatory. Stirling, A. (2001), ‘The precautionary principle in science and technology’, in T. O’Riordan, J. Cameron and A. Jordan (eds), Reinterpreting the Precautionary Principle, London: Cameron May, pp. 61–94. Stirling, A. (2003), ‘Risk, uncertainty and precaution: some instrumental implications from the social sciences’, in F. Berkhout, M. Leach and I. Scoones (eds), Negotiating Environmental Change: New Perspectives From Social Science, Cheltenham, UK and Northampton, MA, US: Edward Elgar, pp. 33–76. Stone, C. (2001), ‘Is there a precautionary principle?’, Environmental Law Reporter, 31, 10790–99. Sunstein, C. (2005), Laws of Fear: Beyond the Precautionary Principle, Cambridge: Cambridge University Press. Treich, N. (2001), ‘What is the economic meaning of the precautionary principle?’, Geneva Papers on Risk and Insurance, 26, 334–45. Trouwborst, A. (2002), Evolution and Status of the Precautionary Principle in International Law, The Hague: Kluwer International. Vanderzwaag, D. (1999), ‘The precautionary principle in environmental law and policy: Elusive rhetoric and first embraces’, Journal of Environmental Law and Practice, 8, 355–75. von Moltke, K. (1988), ‘The Vorsorgeprinzip in West German environmental policy’, in Royal Commission on Environmental Pollution, Best Practicable Environmental Option:12th Report, London: HMSO, Appendix Three. Vos, E. (2004), ‘Antibiotics, the precautionary principle and the Court of First Instance’, Maastricht Journal of European and Comparative Law, 11, 187–200. Walker, V. (2003), ‘The myth of science as a “neutral arbiter” for triggering precautions’, Boston College International and Comparative Law Review, 26, 197–228. Wiener, J. and M. Rogers (2002), ‘Comparing precaution in the United States and Europe’, Journal of Risk Research, 5, 317–49. Winickoff, D., S. Jasanoff, L. Busch, R. Grove White and B. Wynne (2005), ‘Adjudicating the GM food wars: science, risk and democracy in world trade law’, Yale Journal of International Law, 30, 81–123. Wirthlin World-wide (2000), The Precautionary Principle: Throwing Science Out With the Bathwater, Wirthlin World-wide Issues Perspective, McLean, VA: Wirthlin Worldwide. Wynne, B. (1992), ‘Uncertainty and environmental learning’, Global Environmental Change, 2, 111–27.

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Cases AP Pollution Control Board v. Nayudu 1999 (1) UJ (SC) 426, Supreme Court of India. Appellate Body Report, European Communities – Measures Concerning Meat and Meat Products (Hormones), 16 January 1998, WT/DS26/AB, WTO Appellate Body. Appellate Body Report, Japan – Measures Affecting the Importation of Apples, 26 November 2003, WT/DS245/AB/R, WTO Appellate Body. Case T-70/99 Alpharma v. Council [2002] ECR II-3495, Court of First Instance. Case T-74/00 Artegodan GmbH v. Commission [2002] ECR II-4965, Court of First Instance. International Tribunal for the Law of the Sea: Southern Bluefish Tuna Cases (New Zealand v. Japan; Australia v. Japan) (Provisional Measures) (1999) 38 International Legal Materials 1624. Vellore Citizens Welfare Forum v. Union of India (1997) 9 Journal of Environmental Law 387, Supreme Court of India.

PART I

General Implications of the Precautionary Principle for Public Decision Making

2. The precautionary principle and its normative challenges René von Schomberg1 1. INTRODUCTION: THE PRECAUTIONARY PRINCIPLE AND DELIBERATION This chapter aims to provide a comprehensive overview of the normative dimensions which need to be addressed while invoking the precautionary principle, implementing it under particular regulatory frameworks and applying it by taking particular measures. It is written from the perspective of a policy analyst, and informed by an EU practice which is still evolving. In the second section, I will give an overview of the normative challenges the precautionary principle faces in terms of deliberation at the levels of politics, policy making and the science-policy interface. In the third section, I will elaborate more specifically on one of the normative considerations which can trigger the precautionary principle, namely ‘reasonable grounds for concern’, which refers to the seriousness of particular threats under circumstances of scientific uncertainty. In the fourth section, I will elaborate on the normative standards for the acceptability of a particular level of protection of the environment or human health. I conclude with an operational definition of the precautionary principle on which all EU policy can and should be based. The precautionary principle is a deliberative principle. Its application involves deliberation on a range of normative dimensions which need to be taken into account while making the principle operational in the public policy context. The term ‘normative’ refers here to all the prescriptive statements and/or value judgements in contrast to factual scientific statements. In this chapter, I will identify and describe all these normative dimensions (see, for a summarized overview, Table 2.1) which involve the invocation, implementation and application of the precautionary principle. Together, they constitute the operational definition of the precautionary principle with which I will conclude (Box 2.1) at the end of the chapter. The normative dimensions consist of a particular scope of deliberation, constrained by particular normative decision modi, normative considerations and an 19

20 Aim at high level of protection

Cost-benefit analysis

Choice of framework

Choice of level of protection/broad societal and community institutions

Broad societal

Political/societal

Policy level

Policy level

Political consensus on PP/Treaty basis

Broad political debate

Political level

Political level

Type of operational rationale

Main type/scope of deliberation

Normative dimension

Implementation of Precautionary Principle

Health takes precedence over economic considerations

High level of protection, consistency, nondiscrimination

Invocation of precautionary principle: scientific uncertainty/threat of adverse effects (two trigger factors)

Factors/normative considerations to be taken into account

Allocation of burden of proof: prior risk assessment to authorization, etc.

Choice of selection rules/ priority setting: e.g. minimalizing costs, maximizing benefits, priority to health etc.

Defining/mapping adverse effects

‘Act rather than not to act’

Normative decision modi

Table 2.1 Deliberation levels involving the progressive invocation, application and implementation of the precautionary principle with its normative dimensions

21

Enabling precautionary practice

Identification of state of affairs in science/ normative qualification of uncertainties Identification of transformable standards

Type of measures

Scientific/normative

Normative basis for acceptability of products/ processes

Policy level

Science-policy interface/risk management

Science-society and policy interface/risk management

Undefined normative standards for acceptability and safety

Lack of knowledge/scientific controversy

Proportionality requirement Application of precautionary principle

Choice of transformable standards: reduction of biodiversity, acceptable levels of temperature rise etc.

Normative qualification of available information. Relating the quality of available information to ‘degree of seriousness’

‘Least onerous measure’/ measures to enable precautionary/learning practice: monitoring, limited licences, traceability/ labelling

22

General implications of the precautionary principle

operational rationale typical for a particular level of deliberation. It should be noted that the different levels of deliberation neither represent a hierarchy nor necessarily a chronological sequence, as deliberation levels mutually inform and refer to each other: deliberation at each of the particular levels can spark new deliberation at any of the other levels. What follows is an ideal-type description of all relevant deliberation levels in relation to the precautionary principle. The architectural framework of interrelating deliberation levels ensures public responsiveness and the accountability of public actors and thereby contributes to the legitimacy of the decision-making process, whereby at the same time the different deliberation levels can ensure a particular quality of outcome by positively selecting arguments in the light of the standards which are supposed to be met and also by negatively filtering out those arguments and preferences which fall below the (often demanding) constraints of the deliberation level concerned. A positive filtering out of arguments towards a consensus is favoured by deliberative procedures, yet they neither aim at nor require consensus, and outcomes can be phrased in various terms, such as clarified decision agendas or outcomes that allow a possible congruency of action of all actors concerned (Grin et al. 2004). Theorists of deliberative democracy work on the clarification of particular levels of deliberation within particular spheres of society. Neblo (2004) describes levels of public deliberation in terms of ‘deliberative breakdown’. Fischer (2003) and Dryzek (1990) describe procedures of discursive politics. Grin et al. (2004) define particular deliberations as practices of ‘reflexive design’. I will elaborate here the deliberation levels with their particular normative dimensions which need to be addressed while invoking the precautionary principle, implementing it under particular regulatory frameworks and applying it by taking particular measures.

2. THE NORMATIVE POLITICAL DIMENSION OF DECISION MAKING 2.1 The Invocation of the Precautionary Principle for a Particular (Policy) Field At the initial level of considering the invocation of the precautionary principle, one has to distinguish between applying it in the context of a particular regulation, such as EU regulations concerning genetically modified organisms (GMOs) and existing national laws, and the political decision to invoke the precautionary principle for a particular subject matter, (such as agricultural biotechnology, climate change or the protection of the ozone

The precautionary principle and its normative challenges

23

layer), before any regulation or law is available. At this initial level, the decision is purely a political one. Even if there is no existing regulation regime existing in relation to the issue, such a political decision is, and should be guided by, a definition or general understanding of the precautionary principle which provides a rationale for action. Over recent years such a rationale and understanding have emerged from political discussions at the international level, and are reflected in several descriptions of the principle in international agreements, and in the EU (apart from the formal inclusion of the precautionary principle in the EU treaty) in court rulings of the European Court of Justice, Communications from the European Commission and most recently in the general principles and requirements of EU food law. In any specific case, the rationale specifies particular circumstances, for which the possible invocation of the precautionary principle is specifically reserved; this consists of two crucial elements: 1.

2.

The principle is to be applied in cases of potential adverse impacts on the environment or human health with serious consequences (thus implying that these consequences are unacceptable if true). For the normative dimension concerning the concept of ‘seriousness of these consequences’, see further below. Governmental action should be taken even though ‘complete’ scientific evidence is not available, there is ongoing scientific controversy, and/or there are disagreements about the lack of (scientific) knowledge. These circumstances are referred to as instances of scientific uncertainty. Scientific uncertainties arise because of controversies over the possibility of adverse effects to the environment or human health, their scope or their degree of seriousness.

The precautionary principle establishes a rationale for action: it substantially lowers the (threshold) level for action of governments (and possibly, depending on its national implementation, makes it easier for governments when citizens or interest groups appeal to the precautionary principle in socio-political or judicial controversies). It represents a departure from the previous state of affairs where political actors could use or abuse a persistent dissent among scientists as a reason (or excuse), for not taking action at all.2 2.2

Chosen Level of Protection

Every nation state has under international agreements the sovereign right to determine its own level of protection. For a particular nation, this level can either be higher or lower than the level applied by other nations

24


depending on its economic situation and socio-political priorities. With or without the precautionary principle, nations can thus determine such a general level of protection as they deem to be appropriate. Having the precautionary principle in place does not imply any new standard setting and therefore does not, for instance, imply the application of strict (or stricter) environmental or health standards: it only changes the way nations can act when they want to implement their chosen levels of protection in the light of scientific uncertainty. When it comes to protecting the environment or human health, the essential normative political choice is thus the determination of the chosen level of protection. However, the level of protection is not always very clearly determined or defined. The EU treaty states only that the level of protection should be ‘high’ (for example, for environment, consumer protection, human, animal and plant health).3 It has been clarified that this does not necessarily have to be the highest level that is technically possible, and depending on the regulations involved, Community institutions do enjoy a broad discretion in relation to the determination of the level of risk deemed unacceptable for society. Therefore, ‘consistency’ and ‘nondiscrimination’ become relevant guidelines while invoking the precautionary principle and determining the chosen level of protection in a particular field and over a particular time frame (European Commission, 2000). The precautionary principle can only legitimately be invoked, according to its rationale described above, if there is a threat that this chosen level of protection could be violated by particular products or activities. The proper application of the precautionary principle has to be seen in the light of this chosen level of protection. The choice of the level of protection determines the actual standards for health and the environment which should be employed. This normative and political choice will have to be applied within all policies and is independent of the invocation of the precautionary principle. In most cases, the level of protection is hardly ever defined in quantitative terms. Indeed in cases of significant scientific uncertainty, such quantification is not feasible. Moreover, one is possibly not even sure whether anticipated adverse effects actually pose a problem for our chosen level of protection (and therefore, possibly, should not be seen as adverse effects after all) or one is not aware of effects which may indeed pose such problems. Some asked the ‘so, what?’question when the spread of transgenes into the environment as a possible consequence of massive use of GMOs was defined as a possible unacceptable environmental effect (Vries, 1999). In the context of climate change, for instance, there are no clearly defined standards for temperature rise which were to be seen as unacceptable: the uncertainty of the science is related to the uncertainty of what still could count as


25

acceptable in terms of health and environmental effects. Invoking the precautionary principle, therefore, implies a delicate interplay between the choice of possible normative standards of acceptability and scientific assessments concerning whether such standards would be violated without regulatory measures. While invoking the precautionary principle, one may, in the light of the acquisition of new knowledge, need to redefine the level of protection as well. In paragraph 2.4, I will elaborate further on the normative implications of the choice of standards. It is important to recollect at this point that the combination of an operational rationale of the precautionary principle and the obligation of maintaining a high level of protection (accompanied with possible non-quantified standards) sets the terms of the debate. At this stage of our deliberation, the question on the use of normative qualifiers which are connected to the effects which trigger the precautionary principle can already be clarified: the terms ‘negative’, ‘serious’ or ‘significant’ cannot be operationalized in a public policy context, since their use would start a new discussion on their degree of seriousness, significance and so on. The only possible proper qualifier is therefore the ‘chosen level of protection’, so that any possible infringement of that level can count as ‘negative’, ‘serious’, and so on. I will use the general term ‘adverse’ effect in the sense that it implies an infringement of that level of protection. 2.3

The Choice and Design of a Particular Framework

The political dimension of the initial invocation is not fully exhausted by the mere existence of a constitutional or European Treaty-based rationale for the precautionary principle. It is important to note that the precautionary principle is, at the level of the EU Treaty, a formal principle, which implies that, depending on the area to which it will be applied, it will result in quite different types of environmental policies or regulations with a range of possible measures, which in themselves are in need of a proper justification. Although the basic rationale justifies proactive action, the range of possible actions might vary considerably and it also raises the issue of applying the precautionary principle in a consistent, non-discriminatory and proportional way, for all areas concerned. The European Commission had to set up guidelines for the application of the precautionary principle among others, in order to tackle this issue, thereby ensuring that it can and will not be abused as a disguised protectionist trade measure and is compatible with the EU’s international obligations such as those under the WTO and the UN (European Commission, 2000). Two of these guidelines stand out in relation to decisions with a normative political nature, namely the requirement for a

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proportional application of the precautionary principle and the requirement to examine the benefits and costs of action or lack of action. The latter requirement has also been mentioned as a requirement for environmental policy in the Treaty on the European Union (European Union, article 172 of the title on the environment). As far as the examination of the benefits and costs of action or inaction is concerned, it has to be taken into account that human health issues in the EU take precedence over economic concerns4 and the Commission’s guidelines clearly state that this examination should not be reduced to a pure economic weighing of costs and benefits (European Commission, 2000 and European Council, 2002). Christoforou (2003) rightly points out that this type of consideration does not play a decisive role in whether to adopt a precautionary principlebased regulation or policy, but only in the actual choice or design of the framework. The choice and the design of the framework are part of political deliberations before they result in actual regulations and policies, and this is why I see this aspect of the implementation of the precautionary principle as being at the normative political level. The EU regulation on genetically modified organisms, for example, shows a particular design of a precautionary regulatory framework. It established a case by case and step by step procedure (Schomberg 1998). The framework does not prejudge the acceptability of individual GMO releases. It thereby takes a normative stand on GMOs as such, since it defines GMOs as a priori potentially hazardous, and shifts the burden of proof to the proponents of the activity, for example the applicant for a GMO release has to demonstrate safety rather than regulatory agencies or third parties having to demonstrate a risk.5 The European Court has also confirmed that the legislation ‘already makes provision, as one of the possible ways of giving effect to the precautionary principle, for a procedure for prior authorisation of the products concerned’ (Case C-6/99, Association Greenpeace France v. Ministère de l’Agriculture et de la Pêche [2000] ECR I-1651) (italic by the author). 2.4 The Choice of Potential Measures and the Requirement of Proportionality while Implementing the Precautionary Principle Although the requirement of proportionality has its roots in the basic principles of Community Law, it will not and cannot be considered a trump card that could override the invocation of the precautionary principle. Whereas the cost-benefit analysis requirement constrains and guides the setting up of the general regulatory framework of policy actions, the proportionality requirement relates in particular to the normative choice of possible alternative measures under such regulations or policy actions but


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does not eliminate the justification of taking measures as such, based on the precautionary principle. According to Community law the principle of proportionality requires that measures adopted by Community institutions should not exceed the limits of what is appropriate and necessary in order to attain the legitimate objectives pursued by the legislation in question, and where there is a choice between several appropriate measures, recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued. Thus the proportionate implementation of the precautionary principle is not aimed at categorical bans of products or processes (which might jeopardize the learning process) but certainly does not exclude such measures in individual cases. For instance, the EU recently withdrew particular antibiotics in feedstuffs from the market while invoking the precautionary principle. A subsequent very revealing European Court of Justice ruling concerning this antibiotics case, which included a judgment relating to both a contested interpretation of the precautionary principle and the principle of proportionality,6 judged this ban as justified. The principle of proportionality has an impact on the choice of possible measures, and in the trade context, this could mean that one adopts measures that would be the least trade-restrictive. In general terms, the normative line of thinking here is that a proportionate application of the precautionary principle involves the least onerous measure while still attaining the legitimate objective. However, the European Court of Justice has clarified in the context of the judgment Alpharma v. Council (see note 5) that a cost-benefit analysis should be seen as a particular expression of the principle of proportionality in cases involving risk management. I conclude here that because, in the case of the invocation of the precautionary principle, risk management is by definition involved (the invocation of the precautionary principle is a risk management decision in the EU context), the proportionality principle is integrated in the context of a broadly defined costbenefit analysis. The outcome of such an analysis can, therefore, favour another option than the least onerous one in terms of restrictions to trade, depending on the normative decision rules (including priority setting) employed while exercising such an analysis.7 The costs of particular measures can vary considerably in relation to the economic and social importance of the issue at stake as well as whether the invocation of the precautionary principle would lead to interference in planned activities or would involve various degrees of remediation. In the last case, it also matters whether alternatives are available. For example in relation to banning substances that depleted the ozone layer there were alternative products, while in contrast managing climate change requires changing entrenched current practices.

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3. THE NORMATIVE DIMENSION OF ASSESSING THE (EPISTEMIC) UNCERTAINTY CONCERNING THE USE OF SCIENTIFIC KNOWLEDGE The precautionary principle is applied in the context of scientific controversy and the acquisition of new knowledge. In order to apply the precautionary principle properly, a clarification is needed as to what is precisely understood by ‘scientific uncertainty’ and what types of uncertainties are relevant for the invocation of the precautionary principle. In this section I am particularly concerned with the issue of how the normative qualifier ‘reasonable grounds for concern’ can be used for triggering the precautionary principle. Any scientific advice is surrounded by some degree of uncertainty and this in itself is not a reason for, nor usually leads to, the invocation of the precautionary principle. In Table 2.2, I categorize the types of uncertainties, building upon, but significantly modifying, the work of Stirling (1999) and Renn et al. (2003) in this area. Table 2.2 presents an overview of the state of affairs in science and the corresponding responses by risk management and the appropriate regulatory framework. In accordance with what is summarized in Table 2.2, we can distinguish four circumstances. The first relates to ‘hypothetical effects and imaginary risk’. A conjectural approach which involves the identification of a purely hypothetical risk cannot be considered as an invocation of the precautionary principle. Both the EC guidelines on the precautionary principle and the ruling of the European Court of Justice (T70/99 for example) exclude such situations and confirm that any invocation of the precautionary principle should start with a scientific examination of the issue. It involves a mapping or identification of the possible adverse effects and is subsequently followed by a risk assessment. It is acknowledged that such an assessment is not necessarily either complete or conclusive in all its details. This scientific examination can also include or build upon minority views within the scientific field.8 Yet the invocation of the precautionary principle is always scientifically informed9 and, procedurally, it is mandatory to have such an examination available before invoking the precautionary principle. A second type of circumstance which can be distinguished relates to the normal situation of a defined risk, whereby the level of protection is defined, and the risk (for example, the probability of the occurrence of the adverse effects multiplied by their impact) can be quantified. In such situations, the policy makers can respond with a normal risk management approach whereby, for example, thresholds can be set, risks can be either minimized or kept below a certain level, and precautionary measures can be taken to keep particular effects well below particular thresholds by employing the


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Table 2.2 Overview of state of affairs in science and the possible corresponding responses by risk management Circumstances

State of affairs in science

Policy framework/regulatory action/examples

Risk

Known effects, quantifiable probabilities; uncertainties may have statistical (e.g. stochastical) nature

Risk management by defining thresholds on the basis of chosen level of protection, exercising prevention, minimalization of risk and/or precautionary minimalization of risks by feasible management measures: applying the ALARA principle etc.

Unquantifiable risk, lack of knowledge

Known effects/unknown or uncertain cause-effect relations, therefore unknown probabilities

Antibiotics in feed stuff/ protection of the North Sea. Invocation of precautionary principle is justified; preventive measures to take away the possible causes can be justified

Epistemic uncertainty: scientific controversies, lack of knowledge

Unknown scope of effects, however, degree and/or nature of their ‘seriousness’ (in relation to the chosen level of protection) can only be estimated in qualitative terms

Invocation of the precautionary principle is justified. Example: GMOs, climate change, ozone depletion

Hypothetical effect/ imaginary risk

Arguments on the basis of Invocation of precautionary a fully conjectural knowledge principle is not justified base, no scientific indication for their possible occurrence

Sources: Stirling (1999); Renn et al. (2003).

ALARA (as low as reasonably achievable) principle. The invocation of the precautionary principle is neither necessary nor relevant.10 Because there is a scientific consolidated basis concerning the adverse effects in question, one can act with preventive (in contrast to precautionary) interventions. The situation becomes completely different when one encounters a third type of situation in which one cannot fully rely on the scientific information system as such when it comes to the estimation of possible adverse effects. This is notably the case when an epistemic debate is going on in science:11 for example, disciplines use competing models or analogies or basic assumptions

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to disclose the subject matter under investigation in order to acquire new knowledge. In the case of (long-term) effects of the introduction of GMOs, for instance, biotechnologists usually refer, by analogy, to the practice of conventional plant breeding as a basis for making ‘predictions’ concerning their risks. Ecologists, on the contrary refer, also by analogy, to experience based on the introduction of particular species into new environments (thereby causing ‘problem’plants and pests) (Schomberg 1993). This debate even went so far that representatives of the different disciplines dismissed the relevance of each others’ knowledge base for the actual assessment of risks. The epistemic debate concerning the (long-term) effects in terms of their predictability will need decades to be completely resolved: both the analogies of the ecologists and biotechnologists are plausible, but refer to a completely different (potential) scientific information base that still needs to be disclosed by ongoing research. The possible effects of individual releases (although one needs to take into account the accumulation of many releases over time) may not be either fully identifiable, nor be known in their scope (in terms of possible negative indirect, long-term or delayed effects). However these effects might be supervisable and practical management and monitoring practices could enable an early identification of unexpected events. Also their degree of seriousness can be identified to some extent. Particular effects may be irreversible, since if transgenes are in the environment, then they cannot be (easily) retrieved. The situation is different from a classical risk management situation: a precautionary approach can be justified. Less dramatic in terms of scientific debate, but with similar relevance for the invocation of the precautionary principle, are cases relating to a fourth type of circumstance when particular cause-effect relationships cannot be scientifically established while at the same time the adverse effects are known. The withdrawal of the use of particular antibiotics in feedstuffs as well as the protection of the North Sea (dumping of waste) provides us with examples. The overview of these four types of circumstances establishes the need to have an assessment of the state of affairs in science and type of uncertainties involved. Drawing the borderline between classical risk management practice and the situation of a purely conjectural risk involves making normative choices which need to be made explicit. But even more importantly, in the case of epistemic uncertainty, a normative relationship between the nature of the uncertainties and the possible adverse effects needs to be established in order to justify policy and regulatory intervention. In assessing the uncertainty involved, normative qualifiers come into play while invoking the precautionary principle. It does make a difference if the invocation of the precautionary principle needs to be established in relation to the anticipated adverse effects: ‘reasonable grounds for concern’ (EC Communication on the precautionary principle); the identification of possible harmful effects on


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health following an assessment of available information (Regulation EC 178/2002, general principles and requirements of food law); ‘balance of evidence’ (Intergovernmental Panel for Climate Change, 2001); or ‘sufficient evidence for safety’. However it is difficult to outline precisely the normative constraints of the type of scientific information needed which is ‘sufficient’ to trigger it off. Some argue that there is a ‘degree’ of likelihood associated with those qualifiers.12 I find it, however, misleading that one would be able to assess the ‘risk’ of false positives, for example where unnecessary action will be taken on what will later turn out to be fears rather than facts. The uncertainties which are usually involved, are precisely related to the impossibility of assigning a ‘degree’of likelihood to the anticipated adverse effects. Some of the qualifiers belong, in my view, to the vocabulary of risk regulation (such as ‘sufficient evidence’ or ‘identified’ risk) rather than to precautionary practice. I suggest that we should relate the normative qualifiers to the quality of the available information. The quality of the information is not determined by the amount or degree of uncertainty but relates especially to what type of information is known or should be known and of which one is ignorant: for example the knowledge concerning established cause-effect relationships and the degree of necessity to know those relationships in order to make a judgement. The qualifier ‘reasonable grounds for concern’ as employed by the EC guidelines makes, in my view, no statement about the degree of likelihood, but this qualifier relates in fact to a judgement on the quality of the available information. It is, therefore, misleading to situate this qualifier in a scale of possible ‘levels’, or ‘degrees’of proof as Harremoës has suggested (European Environment Agency, 2002). It becomes even more complicated to take the linguistic connotations of suggested ‘degrees’ or ‘levels’ into account. Some may feel that this degree needs to be balanced against the degree of seriousness of anticipated effects. It suggests that a very serious violation of our chosen level of protection would lower our requirements concerning the quality of available scientific information and arguments. This is obviously a particular normative choice which needs to be justified in relation to possible other choices.

4. THE CHOICE OF TRANSFORMABLE NORMATIVE STANDARDS UNDER PARTICULAR REGULATORY FRAMEWORKS WHICH DEFINE THE SOCIETAL ACCEPTABILITY OF PARTICULAR EMISSIONS OR PRODUCTS Precautionary regulation always implies the regulation of a subject matter on the basis of standards that remain open for discussion. The regulation

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itself cannot define these standards. This is a completely new dimension in international environmental policy and not always appreciated. I will illustrate this point again with the case of GMOs. The European directive on GMOs (European Communities, 2001, Article 4) states: ‘Member States shall, in accordance with the precautionary principle, ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release or the placing on the market of GMOs’. The directive leaves open what precisely can be considered as an ‘adverse effect on human health and the environment’. The directive also leaves open what could be ‘a sufficient demonstration of safety’, let alone that it defines the degree of uncertainty which could justify restricted use or a ban of a particular GMO. The combination of a case by case evaluation and the absence of fixed standards for evaluating these cases provide the background for ongoing deliberations at national level and in scientific advisory committees. Without a normative standard, however, it is impossible to draw a valid conclusion on the acceptability of a product or a release. Therefore, risk managers have to make normative assumptions about which products are acceptable or not acceptable. In the case of GMOs, the implicit strategy has been to make an appeal to a conventional norm, that is to say a standard which would be acceptable because one can be certain that it is widely accepted and uncontroversial (and would fit our chosen ‘high level of protection’). What kind of standard would that be? The Netherlands Commission on Genetic Modification (COGEM) made the following statements in the evaluation of the application concerning an herbicide resistant oil-seed rape in June 1994 (COGEM 1994): ‘outcrossing transgenic characteristics will not cause a persistently negative impact on the environment [and] outcrossing the gene and its property male sterility . . . will not lead to a persistently unacceptable impact of these relatives on the composition of varieties in natural vegetation’. To draw a conclusion on the acceptability of an impact, one has to use phrases with normative implications such as ‘negative impact’ or ‘unacceptable impact’. In this case, the advisory committee assumed that a conventional standard, and therefore a non-controversial reference point, would be the ‘natural situation’ itself. It is assumed that so long as any impact could be counterbalanced by nature, which would allow nature to return to its original situation, it would be an ‘acceptable impact’. Generally, this conclusion, which at first glance seems quite uncontroversial, implies that any process or impact caused by releases or new agricultural practices would be acceptable if one finds that such a process or impact would occur in nature itself. Indeed, advisory committees came to


33

the conclusion that herbicide-resistant genes, for instance, are widespread in the natural environment and that, therefore, a possible spread of these genes caused by man-made varieties would be an acceptable phenomenon, comparable with existing natural processes. However unproblematic this appeal to a conventional norm seems to be, it soon runs into difficulties when one tries to apply this normative reference point in diverse cases over time. Our knowledge of nature is far from complete and our perception of nature changes over time while our scientific knowledge grows and our cultural values change. Until several years ago, for example, the general belief was that ‘gene flow’ is not a natural phenomenon (and therefore unacceptable), but now it has been discovered that it occurs under particular circumstance in nature as well, which would turn it again into an acceptable impact (provided one agrees that what happens in nature is always acceptable . . .). So, our further analysis turns our ‘convention’ into a transformable normative standard, which depends on (and evolves synchronically with) the historical change in our perception of nature. If one analyses the case of GMOs in more detail (see Schomberg, 1998), one will find that ‘reduction of biodiversity’ is not the only transformable standard which can be employed while assessing the acceptability of releases. Alternative standards (equally transformable in nature) on which I cannot further elaborate here are: ●

●

‘Comparison with conventional agricultural practices’,13 that is to say, anything that does not yield an impact substantially different from the impact of existing agricultural practices would be considered an ‘acceptable’ release. ‘Compatibility with sustainable agricultural practice’, that is to say only those releases which could be integrated into a sustainable agricultural practice would be considered an ‘acceptable release’.

In the European context, conflicting scientific assessments among scientific advisory bodies can be traced to the normative choice of one of those standards and the way in which these standards were applied, whereas they hardly relate to the probability of major environmental impacts. Consensus on such an issue seems a matter of agreeing on the standard(s) to be used. Until now, precautionary regulation has probably relied too much on an implicit use of such standards. The obvious solution for the problem is to embark on an open discussion on them. I conclude that an undefined high level of protection in combination with a precautionary regulatory framework forces risk managers to look out for standards which are ‘transformable’ by nature in order to make the necessary normative conclusions concerning adverse effects. Analysis of other complex scientific issues, such

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as climate change, the management of large ecosystems and so on, always involve the use of such transformable standards. This is a crucial difference from the context of classical risk management issues under which standards can be pre-defined.

5.

CONCLUSIONS AND OUTLOOK

Precautionary measures are provisional measures by nature, and need to be regularly reviewed when scientific information either calls for their relaxation strengthening. Within the EU context, these provisional measures do not have a prefixed ‘expiry’ date: one can only lift precautionary measures if scientific knowledge has progressed to a point that one would be able to translate (former) uncertainties in terms of risk and adverse effects into defined, consensual levels of harm or damage. Precautionary frameworks facilitate in particular deliberation at the science, policy and society interfaces to which risk management is fully connected. Applying the precautionary principle is to be seen as a normative risk management exercise which builds upon scientific risk assessments.14 An ongoing scientific and normative deliberation at the science/policy interface involves a shift in science-centred debates on the probability of risks towards a science-informed debate on uncertainties and plausible adverse effects: this means that decisions should not only be based on available data but on a broad scientific knowledge base including a variety of scientific disciplines. I have above elaborated the essential normative dimensions of the invocation and application of the precautionary principle. I propose to distinguish between risk-based regulation (which applies to the classical situation of a defined risk) and uncertainty-based regulation under a precautionary regulatory framework (see Table 2.3.). The table shows, in accordance with our discussion above, that there is actually uncertaintybased regulation assumed under a precautionary regulatory framework.15 The shift from risk-based regulation to uncertainty-based regulation under a precautionary regulatory framework needs a new justification since the vocabulary of a risk assessment model is inappropriate for that type of practice. The application of transformable standards is an inherently discursive process. In relation to each single case such standards need to be applied over and over again, with possible different outcomes over time. These normative standards reflect and should reflect the chosen ‘aim of high level of protection’ as enshrined in the EU Treaty. In a certain sense, this is also a transformable standard in itself, since what is considered as


35

‘high’, changes over time and relates to socio-economic circumstances. The impossibility of defining fixed standards and of operating with necessary open standards is a positive feature of a regulatory framework in democratic societies. It invites citizens to discuss those standards, as they cannot be solely defined by risk managers and scientific advisers. The challenge is to interconnect those standards with the discussions within scientific committees, the risk management level and society at large. Technology assessment and technology foresight exercises can thereby be helpful to feed such a deliberative process. Expertise needs also to be extended with forms of knowledge assessments to assess the normative quality of the information, in order to identify the meaning of particular uncertainties, the quality of the available knowledge (which includes knowledge beyond the area of science), and their relevance for policy (Schomberg et al., 2005). In the meantime, a significant progress has been achieved in dealing with scientific uncertainty by taking into account all relevant scientific disciplines while asking for scientific advice. (See among others, the EC guidelines on democratizing expertise (European Commission, 2002)). Institutional innovations have also taken place: the regulation EC 178/2002 which establishes the European Food Safety Authority (EFSA) foresees in particular, among Table 2.3

Characteristics of regulatory systems

Risk-based regulation

Uncertainty-based regulation

Identifying risks

Assessing uncertainties/state of affairs in science

Applying standards of acceptable risks

Applying transformable (deliberationbased) standards of acceptable uncertainties Appealing to normative transformable standards

Applying definitions of harm Calculating the chance of occurrence of probable effects

Assessing the plausibility of possible adverse effects

Policy objective: minimizing risks etc.

Policy objective: reducing uncertainties; enabling precautionary and learning practice etc.

Possibility of avoidance of predictable long-term effects by prevention

Prospective long-term effects can only be identified to some extent, precautionary measures such as monitoring could enable the early identification of adverse effects over time

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others, procedures when scientific opinions diverge, entailing an obligation to cooperate together with the relevant body (when the body with the diverging view is a Community body) to work together with a view to clarifying the issue, and an obligation to publish the joint findings in a publicly accessible document. There is also an obligation of the authority actively to identify and contact non-community bodies with a diverging view, in order to share the information. There is also a growing recognition of the normative challenges involved while invoking the precautionary principle. Under particular precautionary regulatory frameworks, such as the regulation of the European Parliament and of the Council on genetically modified food and feed, it is for example recognized ‘that a risk assessment alone cannot provide all the information on which a risk management decision should be based, and that other legitimate factors relevant to the matter under consideration may be taken into account’ (European Communities (2003), paragraph 32 of the preamble). I conclude by summarizing that the invocation, implementation and application of the precautionary principle follows a progressive line of different levels of deliberations (which obviously can be interconnected to each other but are distinguished here for analytical purposes). I have listed these levels of deliberation in Table 2.1. The table provides a model for guiding all the relevant normative levels of deliberation which are needed in order eventually to make legitimate conclusions on the acceptability of products or processes. The table provides a progressive line of those levels of deliberations from the initial invocation of the precautionary principle at the political level down to the level of risk management decisions, but at the same time show their interrelatedness. Although Table 2.1 may suggest a particular sequence in an ideal world (for example, from the political level downwards), practically, the ‘entry’ stage can be at any level and those levels do not represent a hierarchy in any sense. Practices which were formerly not based on the precautionary principle may become based on it by discussions which arise at the science/policy interface. I conclude with the (ultimate?) overall definition of the precautionary principle (rather than a specified definition of the precautionary principle for a particular area, such as the environment, human health or food safety) while remaining within the wide scope and limits of the recent rulings of the European Court of Justice, the broad EU endorsement of the European Guidelines on the precautionary principle, and international obligations under international Treaties such as those under the WTO and the UN. The definition contains all the normative dimensions discussed in this contribution. Box 2.1 contains the definition of the precautionary principle and Box 2.2 contains the explanation of the terminology.


BOX 2.1

POLICY DEFINITION OF THE PRECAUTIONARY PRINCIPLE

Where, following an assessment of available scientific information, there are reasonable grounds for concern for the possibility of adverse effects but scientific uncertainty persists, provisional risk management measures based on a broad cost-benefit analysis whereby priority will be given to human health and the environment, necessary to ensure the chosen high level of protection in the Community and proportionate to this level of protection, may be adopted, pending further scientific information for a more comprehensive risk assessment, without having to wait until the reality and seriousness of those adverse effects become fully apparent.

BOX 2.2

EXPLANATION OF THE TERMINOLOGY OF THE DEFINITION OF THE PRECAUTIONARY PRINCIPLE

Where, following an assessment of available scientific information: this formulates the formal obligation to have a scientific assessment. There are reasonable grounds for concern: normative qualifier employed in the EC guidelines on the precautionary principle as a requirement to relate the quality of the available information (rather than ‘degree of uncertainty’) to the seriousness of possible adverse effects. the possibility of adverse effects: adverse effects is a general formula for effects inconsistent with the chosen level of protection in relation to health, environment and so on. It concerns one of two basic trigger factors for the invocation of the PP.The term can be replaced by, for example, ‘harmful effect for health’ for the area of food. (This wording has indeed been incorporated as a definition of the precautionary principle in the general principles of EU food law.) but scientific uncertainty exists: refers to the other trigger factor concerning the invocation of the PP. Provisional risk management measures: refers to the mandatory provisional nature of measures.

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the chosen high level of protection in the Community: relates to the Community situation, and can be replaced by other definitions in other societal contexts or renewed definitions in the Treaty or constitution. Proportionate to this level of protection: relates to the mandatory requirement of the application of the principle in accordance with Community law and as an expression of or part of a general costbenefit analysis (as required by the EC guidelines on the PP). following a cost-benefit analysis, whereby priority will be given to human health and the environment: reflects political priorities as defined by the Nice Resolution, but which are also enshrined in the Treaty as clarified by rulings of the European Court of Justice. The Nice Resolution also called for a broad cost-benefit analysis.This formula can be left out under particular regulations since this analysis will be conducted with a view to the architectural framework of such a regulation. pending further scientific information for a more comprehensive risk assessment: expresses the mandatory character of an ongoing risk assessment and the accumulation of scientific knowledge. The expression ‘comprehensive’ is preferable over ‘more objective’ as used in the context of the Sanitary and Phytosanitary Agreement and is based on a particular view of science which is not the contemporary one. It articulates also the fact that these assessments do not necessarily have to be, or can be, complete by nature. may be adopted . . . without having to wait until the reality and seriousness of those adverse effects become fully apparent: follows the wording of a recent and above-cited Court ruling and expresses the general understanding and rationale of the PP: this wording legitimates early action by government. The formulation of the PP, as principle 15 in Agenda 21, seems more compelling: (. . .) no reason for postponing cost-effective measures to prevent . . .’.

NOTES 1. René von Schomberg is at the European Commission, Directorate General for Research. The views expressed here are those of the author and may not in any circumstances be regarded as stating an official position of the European Commission. Email: [email protected]. I want to thank Elizabeth Fisher, William Lawless and an anonymous reviewer for comments on an earlier draft of this chapter.

The precautionary principle and its normative challenges 2.

3. 4. 5. 6. 7.

8.

9.

10. 11. 12. 13.

14.

15.

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Case C-180/96, United Kingdom v. Commission [1998] ECR I-2265 and Case 157/96, R v. Ministry of Fisheries and Food, ex parte National Farmer’s Union [1998] ECR I-2211 on the validity of the European Commission’s decision banning the exportation of beef from the United Kingdom to reduce the risk of BSE transmission, reveal a similar rationale for action based on the precautionary principle, for the human health area: ‘Where there is uncertainty as to the existence or extent of risks to human health, the institutions may take protective measures without having to wait until the reality and seriousness of those risks become fully apparent’. ‘Community policy on the environment shall aim at a high level of protection taking into account the diversity of situations in the various regions of the Community’, European Union (2002), article 174, paragraph 2. Order of 30 June 1999, Case T 70/99, Alpharma v. Council: ‘requirements linked to the protection of public health should undoubtedly be given greater weight than economic considerations’. The EU regulation concerning chemicals (under loud protest from EU’s industry) moves in a similar direction with a mandatory risk assessment to be produced by the applicant. Judgment Case T-70/99, Alpharma v. Council [2002] ECR II-3495. This judgement and the ongoing interpretations of the proportionality principle are well reflected in Vos (2004). I cannot enter here into details on the possible normative choice of options while choosing normative selection rules such as: ‘maximizing benefits while minimizing costs/disadvantages’, or only ‘minimizing costs/disadvantages’ and using priorities such as ‘avoiding health effects’ or ‘irreversible effects’. Minority views, however, do not need to be seen in isolation. Scientific evaluations work best in the context of independent scientific peer review, as demonstrated, for example, by Lawless and Grayson (2004). It speaks for itself that those scientific evaluations need to be done in a transparent way and that the results are publicly accessible. I prefer the use of the terminology ‘scientifically informed’ over ‘science-based’, which has the connotations that the precautionary principle would only have a factual basis. It also seems to refer to a US context and the mere wish to copy US practice, rather than really relating it to actual European reality. In this chapter, I argue in fact the contrary position, namely that it has a normative basis but, at the same time, is (on a mandatory basis) scientifically informed and can only be triggered by scientific assessments. Note that one can take ‘precautionary’ measures without invoking the precautionary principle. I have characterized the nature of ‘epistemic debates’ in Schomberg (1995). A short overview appeared in Schomberg (1993). This argument, developed by Poul Harremoës, is partially reflected in a table with ‘levels of proof’ in European Environment Agency (2002). There seems to be a sort of institutional preference to compare alternatives with current practice. However, before taking current practice as the default norm or benchmark, one needs to evaluate whether future developments do not allow us to get to policies which retrospectively define current practices as insufficient. The ‘sustainability’ requirement inherently links to such discussions. It is therefore not imaginable that a proper invocation/implementation and application of the precautionary principle is based solely on a ‘perceived’ risk. I cannot enter here into the discussion on the distinction between actual versus perceived risks. Under my framework ‘perception’ is not something which is entirely defined by the ‘lay public’, nor is any ‘actual’ risk element entirely defined by experts. Since the application of the precautionary principle starts with an (as yet incomplete) scientific risk assessment, any ‘perceptional’ element is already initiated with a scientific content. Regulators and political actors often still justify this type of regulation in terms of a riskbased regulation. However, no one can either justify how to translate uncertainty to risk, or justify how to translate normative transformable standards to definitions of harm.

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REFERENCES Christoforou, T. (2003), ‘The precautionary principle and democratising expertise: a European legal perspective’, Science and Public Policy, 30, June, 205–13. COGEM (The Netherlands Commission on Genetic Modification (1994), Letter of COGEM to the Dutch Minister for the Environment with reference nr C/UK/94/MI/1, available from the public register, library of the Dutch Ministry for the Environment (VROM), The Hague, 21 June. More recent publications and documents, including correspondence of COGEM, can be retrieved from http://www.cogem.net/eng/index.htm. Convention on Biological Diversity (2000), http://wwwi.biodiv.org/convention/ default.shtml (accessed 21 October 2005). Dryzek, J.S. (1990), Discursive Democracy: Politics, Policy, and Political Science, Cambridge: Cambridge University Press. European Commission (2000), Communication from the Commission on the Precautionary Principle, (COM 2000/001), Brussels. European Commission (2002), Communication from the Commission on the Collection and Use of Expertise by the Commission: Principles and Guidelines: ‘Improving the Knowledge Base for Better Policies’: COM (2002) 713 final, Brussels. European Communities (2001), Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council directive 90/220/EEC-Commission Declaration, Official Journal of the European Communities, L 106, 17 April. European Communities (2002), Regulation (EC) 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, Official Journal of the European Communities, L 31, 1 February. European Communities (2003), Regulation (EC) 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, Official Journal of the European Union, L268/1, 18 October. European Council (2002), Resolution on the Precautionary Principle, Brussels. European Environment Agency (2002), Late Lessons from Early Warning, Copenhagen: EEA. European Union (2002), European Union consolidated versions of the treaty on European Union and of the treaty establishing the European community, Official Journal of the European Union, C325, 24 December, Title XIX, article 174, paragraphs 2 and 3. Fischer, F. (2003), Reframing Public Policy: Discursive Politics and Deliberative Practices, Oxford: Oxford University Press. Grin, J., F. Felix, B. Bos and S. Spoelstra (2004), ‘Practices for reflexive design: lessons from a Dutch programme on sustainable agriculture’, International Journal of Foresight and Innovation Policy, 1 (1/2), 126–49. Habermas, J. (1996), Between Facts and Norms: Contributions to a Discourse Theory of Law and Democracy, Cambridge, MA: MIT Press. Intergovernmental Panel for Climate Change (2001), Climate Change 2001: Working Group I: The Scientific Basis, Contribution of Working Group I to the Third Assessment Report of the Intergovernmental Panel on Climate Change, accessed June 2005 from http://www.ipcc.ch/.


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Kriebel D., J. Tickner, P. Epstein, J. Lemons, R. Levins, E. Loechler, M. Quinn, R. Rudel, T. Schettler and M. Stoto (2003), ‘The precautionary principle in environmental science’, Environmental Health Perspectives, 109 (9), Sept, 871–6. Lawless, W.F. and J.M. Grayson (2004), DOE’s Policy of Consensus Seeking Versus Truth Seeking in Traditional American Democracy, West Management Symposium 29 February – 4 March, Tuscon, AZ. Neblo, M.A. (2004), Thinking through Democracy: Deliberative Politics in Theory and Practice, paper presented at the Conference on ‘Empirical Approaches to Deliberative Politics’, European University Institute, Firenze, 21–22 May. Renn O., M. Dreyer, A. Klinke, C. Losert, A. Stirling, P. van Zwanenberg, U. MullerHerold, M. Morosini and E. Fisher (2003), The Application of the Precautionary Principle in the European Union: Regulatory Strategies and Research Needs to Compose and Specify a European Policy on the Application of the Precautionary Principle (Precaupri), project financed as a STRATA under the Improving Human Potential Programme of the EC, Stuttgart: Centre for Technology Assessment. unpublished. Robinson, N. (ed.) (1992), Agenda 21 and the UNCED Proceedings, vol 1. New York: Oceana. Stirling, A. (1999), On Science and Precaution in the Management of Technological Risk, Seville: IPTS. Schomberg, René von (ed.) (1993), Science, Politics and Morality: Scientific Uncertainty and Decision Making, Dordrecht: Kluwer Academic Publishers. Schomberg, René von (1995), Der Rationale Umgang mit Unsicherheit, Frankfurt am Main: Peter Lang. Schomberg, René von (1998), An Appraisal of the Working in Practice of Directive 90/220 Concerning the Deliberate Release of Genetically Modified Organisms in the Environment, Luxembourg: STOA report of the European Parliament, http://www.europarl.eu.int/stoa/publications/studies/19971101_en.pdf (accessed 4 April 2006). Schomberg, René von (2002), ‘The erosion of value spheres: the ways in which society copes with scientific, moral and ethical uncertainty’, in R. von Schomberg and K. Baynes (eds), Discourse and Democracy: Essays on Habermas’ Between Fact and Norms, Albany: State University of New York Press, pp. 219–41. Schomberg, René von, Angela Guimarães Pereira and Silvio Funtowicz (2005), Deliberating Foresight-Knowledge for Policy and Foresight-Knowledge Assessment, Brussels: European Commission, Directorate General for Research, also http://www.cordis.lu/foresight/working.htm Vos, Ellen (2004), ‘Antibiotics, the precautionary principle and the Court of First Instance’, Maastricht Journal of European and Comparative Law, 11, 187–200. Vries, Gerard de (1999), Commission on Genetic Modification, Proceedings of the Second International CCRO Workshop, Bilthoven, Netherlands, pp. 125–36.

Cases Case T-70/99, Alpharma v. Council [2002] ECR II-3495. Case C-6/99, Association Greenpeace France v. Ministère de l’Agriculture et de la Pêche [2000] ECR I-1651. Case 157/96, R v. Ministry of Fisheries and Food, ex parte National Farmer’s Union [1998] ECR I-2211. Case C-180/96, United Kingdom v. Commission [1998] ECR I-2265.

3. The role of science and precaution in environmental and public health policy1 Joel Tickner and David Kriebel The precautionary principle has often been portrayed as contrary to the tenets of sound science and inconsistent with the norms of ‘science-based’ decision making (Morris, 2000; Holm and Harris, 1999). Others view it as simply a management principle applied only after ‘objective’ scientific inquiry (European Commission, 2000). We believe that these critiques are based on a fundamental misunderstanding of environmental science2 and its role in policy. Most pressing environmental crises share a fundamental characteristic: they appear to arise from disruptions of natural systems or cycles, the behaviour of which is only partially understood. Global warming, endocrine disruption, ecological and health risks from genetically modified organisms and environmental breast cancer risks, are hazards about which there remains a great deal of uncertainty. We draw two conclusions from this problem of uncertainty: first, more scientific research is greatly needed to fill the gaps in our knowledge. Second, while waiting for more complete understanding, we must find ways to make decisions that are based on the best available science, while acknowledging the uncertainties that remain. We believe, therefore, that there is no contradiction between good science and precautionary action. The purpose of this chapter is to examine the precautionary principle and its relationship to science, as well as the barriers to science playing a more protective role in characterizing risks and developing solutions. We examine this relationship from the perspective of United States (U.S.)based scientists and the U.S. political and legal system, though the observations and conclusions we make should be generalizable across nations. While many of the issues we discuss with regards to the limits of environmental science and its application in policy have been widely discussed in the literature, few have related these issues to the question of their role in strengthening preventive and precautionary decision making. We make three key points about the relationship between science and precaution in environmental and public health decision making: 42

The role of science and precaution in environmental and public health policy

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1. Precaution demands more rigorous science to characterize complex risks, clarify gaps in knowledge and identify early warnings. Application of precaution means using science not only for the diagnosis of environmental hazards, but also to identify, develop and assess safer alternatives to potentially harmful activities (in other words meeting a social/economic end with any number of technological means). 2. Applying precaution in environmental science is far broader than present practices in science used in public policy. Indeed, the current conduct of environmental science and its application in policy can in many ways work against preventive, precautionary decisions in the face of uncertain risks. 3. There are numerous scientific, legal and institutional barriers to applying precaution in science and policy that can and should be overcome. If we are serious about preventing costly damage to health and ecosystems, we need to rethink science policy and funding priorities to ensure that we are using the best possible science and technology to achieve a more sustainable, economically prosperous society.

DEFINING PRECAUTION Put simply, the need for precaution arises because of uncertainty. If all potential hazards could be quantitatively assessed with minimal error, then it would be relatively easy to base policy decisions on quantitative risk assessments, and little else. However, in a world in which global weather, aquifers and growing children still hold many mysteries, we believe the best environmental policies will be informed by the best available science, but will also be guided by a principle of erring on the side of caution. Throughout the centuries, precaution has been at the heart of medical and public health theory and practice and is an underpinning to many of our current environmental and public health policies. The precautionary principle has its roots in the German word Vorsorgeprinzip (BoehmerChristiansen 1994). An alternative translation of this word is the ‘foresight principle’ or ‘forecaring principle’ which has the advantage of emphasizing anticipatory action – a proactive idea rather than precaution, which to many sounds reactive and even negative (Kriebel et al., 2001). This definition is very critical to the role of science in policy and is discussed below. While the precautionary principle has provoked considerable controversy in the United States (and many other countries throughout the world), it is not a completely foreign concept in the U.S. Precaution has

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been implicit in many early laws (such as those dealing with drugs, clean water, occupational health and food additives) and forms part of many recent state and local environmental policies (see Tickner, 2000 and Lowell Center for Sustainable Production, 2003, for more examples). Yet the international definitions of the precautionary principle unfortunately have little utility in the U.S. context where the regulatory process is heavily prescribed (administrative laws, executive branch mandates and court decisions all influence and bound decision-making processes), there is little room for agency discretion in many cases and decisions are likely to be challenged in the courts. Broad statements of principle are not easily defended in the face of challenges by regulated communities (see below). As such, proponents of the precautionary principle in the U.S. identified a need for a U.S.-focused definition of the principle and how it should be applied in policy. Because of the culture of innovation in the U.S. and the inherent negativity in the concept of ‘precaution’, a more proactive definition was needed. The participants at the 1998 Wingspread Conference on the Precautionary Principle, attended by 35 scientists, advocates and policy makers from the U.S. and Europe, defined the principle as follows: ‘when an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically’. The statement listed the two central components of the principle from most international declarations: (1) taking preventive action in the face of uncertainty; and (2) shifting burdens on to proponents of potentially harmful activities. But it also identified two new and very important components of precaution for the U.S. context: (1) exploring a wide range of alternatives to possibly harmful actions (an innovation and forward looking goal); and (2) increasing public participation in decision making (to counter the role of financial interests in public policy) (see Raffensperger and Tickner, 1999). This definition has been further refined and elaborated on in numerous analyses and a new analytical framework, called ‘precautionary assessment’ has been proposed to instil precautionary considerations in the U.S. regulatory context (see Tickner, 2000). Adapting the precautionary principle to the U.S. context, one could say that precaution shifts the questions asked in environmental and health policy from ‘what level of harm is acceptable’ to ‘how much harm is preventable’. Precaution is about how we make better, more healthprotective decisions under conditions of uncertainty. Rather than serving as a ‘hammer’ when a specific threshold of evidence is reached, precaution should be viewed as a compass that guides science and policy in the face of uncertainty (Tickner et al., 2003). When viewed in this context, there is an important role for science – for characterizing complex potential harm


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(acting in the face of uncertainty) and for developing solutions (developing and seeking safer alternatives to potentially harmful activities.

HOW SCIENCE CAN MORE EFFECTIVELY SUPPORT PRECAUTIONARY POLICIES The precautionary principle has many implications for environmental science: what we study, how we study it, and how we summarize and communicate results. Environmental science is critical to solving some of our most pressing, uncertain and complex environmental problems, and hence can be very supportive of precautionary policies. As environmental science faces the increasing challenges of more complex risks with greater uncertainty and ignorance, the nexus between science and preventive policy becomes even more important. In this context, we believe that there is no contradiction between good science and precaution – rather than demanding less science, it demands more rigorous and transparent science – that provides insights into how health and ecosystems are disrupted by technologies, identifies and assesses opportunities for prevention and restoration, and indicates clearly gaps in our current understanding of risks (see Kriebel et al., 2001). We need a greater emphasis on interdisciplinary research to understand complex ecological and human systems in order to understand the underlying causes of disease and degradation. We need better surveillance and health tracking systems to identify early warnings of problems, to understand the impact of our interventions and to gauge the overall health of our population and ecosystems. And finally we need to apply science more wisely to studying and developing safer alternatives to substances and activities for which there is scientific evidence of concern. By identifying and analysing alternatives to potentially harmful activities we may be able to circumvent some of the often contentious and time consuming debates that occur around characterizing precise ‘safe’ levels of exposure. A shift to more precautionary policies creates opportunities and challenges for scientists to think differently about the way they conduct studies and communicate results. The 2001 Lowell Statement on Science and the Precautionary Principle, drafted by 85 scientists from 17 countries, outlines changes in science and science policy that would more effectively address uncertain, complex risks, including (Tickner, 2003b): ●

A more effective linkage between research on hazards and expanded research on primary prevention, safer technological options and restoration;

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General implications of the precautionary principle ● ●

●

●

Increased use of interdisciplinary approaches to science and policy, including better integration of qualitative and quantitative data; Innovative research methods for analysing the cumulative and interactive effects of various hazards to which ecosystems and people are exposed; for examining impacts on populations and systems; and for analysing the impacts of hazards on vulnerable sub-populations and disproportionately affected communities; Systems for continuous monitoring and surveillance to avoid unintended consequences of actions, and to identify early warnings of risks; and More comprehensive techniques for analysing and communicating potential hazards and uncertainties (what is known, not known, and can be known).

Currently there is much discussion about what has been termed ‘sound science’ – a term often used to represent the standard methods of quantitative risk assessment (see://www.epa.gov/epahome/research.htm). A quantitative risk assessment may not be the most appropriate scientific method for uncertain risks because the type of evidence reviewed is too rigid and does not consider that alternative methodologies can shift the very concept of acceptable risk (see O’Brien, 2000; Tickner, 2000). A more precautionary approach should be informed by the most ‘appropriate science’, which can be understood as a framework for choosing methods and tools to fit the nature and complexity of the problem (see Kriebel et al., 2003). Critical to this framework is the flexibility to integrate a variety of research methods and data sources into the problem evaluation, and an ability to consult with many constituencies to understand the diversity of views on a problem and seek input on alternative solutions. Complex environmental problems which arise in poorly understood systems like the global environment also require new approaches to examining the whole of the evidence rather than its separate parts. Appropriate science is solutions-based, focused on broadly understanding risks, but also on finding ways to prevent them in the first place. Under this approach, the limitations of science to characterize complex risks fully are openly acknowledged, making it more difficult to use incomplete knowledge to justify preventive actions. Sir Bradford Hill, the often misquoted father of modern epidemiology, recognized the need to act on the basis of limited scientific knowledge, informed judgment and common sense when he said ‘All scientific work is incomplete – whether it be observational or experimental. All scientific work is liable to be upset or modified by advancing knowledge. That does not confer upon us a freedom to ignore the knowledge we already have or to postpone the action that it appears to demand at a given time’ (Hill 1965).


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The critical question for decision makers under an appropriate science and precautionary approach is not causality but rather whether there is enough evidence to act to prevent a particular risk. In this respect environmental science, being an applied science, serves the purpose of informing policy, of helping decision makers understand when and if there is enough evidence to act. When there is enough evidence to act should vary depending on the nature of the problem and be a function of the following: ● ● ● ● ● ●

The available knowledge and accumulated understanding; The complexity, magnitude and uncertainty of the risk; The presence of high-risk populations; The availability of options to prevent the risk; The potential implications of not acting to prevent the risk; and Social and public values.

We provide below three examples of a precautionary approach to science and policy. 1.

Massachusetts Toxics Use Reduction Program

The Massachusetts Toxics Use Reduction Act of 1989 represents a highly successful and efficient precautionary approach to science and policy. The Act encourages firms to identify ways to reduce their reliance on listed toxic substances rather than calculate acceptable emissions levels. The some 1000 substances covered under the law are listed because there is some evidence, though not always proof, of their acute or chronic toxicity. The law does not ban or even directly limit the use of toxic chemicals. Rather, manufacturing firms using listed substances are required to understand how they use chemicals and for what purposes, and to account for the materials they use. They must then develop plans for taking preventive measures to reduce their use of toxic substances and their waste generated, and to measure their progress. In examining safer options, they must analyse potential risks associated with alternative chemicals and processes. Fees collected on toxic substances use are used to fund voluntary technical assistance to firms and research in safer chemicals and processes. In ten years of experience with the Act, toxic chemical emissions have been reduced by more than 80 per cent; toxic waste, almost 60 per cent; and toxics use, almost 40 per cent, all without detailed quantitative risk assessments or command and control requirements. The most important driver for change has been the requirement to understand materials use and examine preventive options. In addition, Massachusetts firms have saved more than $15 million in the process,

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excluding the unquantifiable benefits to health and the environment (see Massachusetts Toxics Use Reduction Institute 1997 and www.turi. org). Under the Massachusetts system, companies use a wide variety of scientific tools, not to calculate the exact risk from chemical exposure (under the law any exposure to a listed chemical is considered too much) but rather to identify and compare alternatives that reduce their use of chemical exposure. 2.

Phthalates and Toys

An example of redefining when we know enough to act in environmental health was the approach taken by the Danish government with the use of phthalate plasticizers in children’s toys. Phthalates are used to make polyvinyl chloride toys flexible and are also used as solvents in cosmetics (nail polish and so on). They are among the most widely dispersed chemicals in the environment and are widely found in human blood and urine as well as household dust (Rudel et al., 2003). The most widely used phthalate, diethylhexyl phthalate is an animal carcinogen and has shown adverse effects on the kidneys and respiratory systems in related animal studies. Of greatest concern is the foetal and neonatal reproductive toxicity of the phthalates, which can affect the testes and sperm production and development, and cause defects in developing embryos (Tickner et al., 2001). There is little, if any, human evidence on the health risks of phthalates. The Danish government took this limited information into consideration when weighing what to do about phthalates in toys. When concerns were raised about these chemicals being used in children’s teething toys (in particular diisononyl phthalate), the Danish government weighed the clear evidence of exposure and uncertain toxicity of the chemical in animal studies, the unique vulnerability of children to environmental contaminants, the existing availability of alternatives and the need for such toys, and determined that precaution should be applied to phase these chemicals out of toys used by small children (Seedorf, 1999). The European Commission followed suit and in 2004 banned the use of such substances in toys. In contrast, in the United States, the Consumer Product Safety Commission – which must quantitatively demonstrate harm before acting – undertook expensive and somewhat non-representative research using adult volunteers to measure children’s exposure (U.S. Consumer Product Safety Commission, 1998). The CSPC came to the conclusion that the risk to children was probably low but that there was a great deal of uncertainty about the risk and companies should voluntarily remove phthalates from toys. The ultimate result in the U.S. and Denmark was the same – the


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chemicals were removed from the toys – but the cost in time (additional exposure to children), resources, and additional expense needed to achieve that result was much greater in the U.S. 3. Polybrominated Diphenyl Ethers in Breast Milk and Other Human Tissues Under the appropriate science approach, often evidence of exposure along with basic toxicological data on a substance – but without clear evidence of risk or harm to humans – will be enough to set basic policies to prevent or reduce exposure. For example, substances called polybrominated diphenyl ethers (PBDE) used as flame retardants in plastics and foams can be found in human body fluids (Päpke et al., 2001). They are found in places where they should not be – in breast milk and in umbilical cord blood of newborns, and PBDE levels have greatly increased in breast milk over the past 20 years (Birnbaum and Staskal, 2004). These substances are strikingly similar in structure to PCBs (polychlorinated biphenyls), a class of compounds we know to be dangerous to human health. Based on concerns regarding their persistence and bioaccumulation in humans, several Scandinavian countries took action to restrict these substances, resulting in decreased levels for the substances in breast milk (Birnbaum and Staskal, 2004). While Europe is moving rapidly to find substitutes for these compounds, the U.S. government has focused primarily on studying their risks (though in late 2003 the U.S. Environmental Protection Agency entered into a voluntary agreement with one manufacturer to stop production of two of these substances).3 The potential of these substances to do harm, even if based on limited evidence, combined with documentation of their presence in breast milk and cord blood should be sufficient to trigger a search for alternative ways to obtain the flame retarding properties of these chemicals. And, if safer alternative ways of providing the same flame-retarding function can be found, then the substitution should not have to wait for quantitative evidence showing that the estimated risk of potential health outcome exceeds an ‘acceptable’ risk threshold.

HOW SCIENCE CAN SLOW PRECAUTIONARY ACTION There are many ways in which methods of scientific inquiry can impede precautionary action, making it more difficult for policy makers to take action in the face of uncertainty. If current scientific methods result in an

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inability to identify early warnings of effects or hide the great uncertainties involved in characterizing complex risks, then precautionary actions can be substantially hindered. Below we examine some of the limitations in the current practice of environmental science that have the potential to work against precautionary policies and actions. Clearly, some of these limitations refer to the practice of environmental science itself (the methodologies and tools used). Some, however, are a reflection of the institutional frameworks which use science and place high expectations on science to provide definitive answers before preventive actions can be taken. The latter limitations are outlined in the next section. Trade-offs Between Two Errors When a scientific investigation is designed to test a hypothesis, there are two kinds of errors that scientists seek to minimize. A Type I error is the mistake of concluding that a phenomenon or association exists when in truth it does not. Scientists guard against such errors by setting that rate of error low, normally 5 per cent. In other words, the finding must be so strong that there is less than a 5 per cent probability that this result would have been seen by chance alone in a world in which no such phenomenon actually exists. In this case the result is called statistically significant (with the clear implication that one is supposed to believe it). The Type II error, failing to detect something that actually does exist, is, by convention, often set at 20 per cent (although practical limitations of sample size – for example a community cancer cluster – often result in substantially higher Type II error rates). This means that 20 per cent of the time, a real phenomenon will be missed because the data were not strong enough to demonstrate convincingly its existence. There is an implicit bias here: studies are set up to be more cautious about falsely detecting something than about failing to detect something (Kriebel et al., 2001). Lack of Interdisciplinary Perspective Scientists tend to study risks from a single disciplinary perspective, even though it might take an interdisciplinary approach to synthesize sufficient evidence to characterize a problem. We know that emerging risks such as those of global change would never have been recognized without the combined effect of concerns raised from different disciplines (McMichael, 1993). It is clear that multidisciplinary teams will be more likely to find new ways to frame hypotheses that lead to insights not possible from narrow disciplinary viewpoints. The recognition of the problem of endocrine disruption provides an example. A review of many different types of


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evidence on the effects of persistent pollutants on wildlife in the Great Lakes led to the hypothesis that a common mechanism of action might be causing a variety of reproductive and developmental effects (Colborn and Clement, 1992). Because of the fragmentation of scientific disciplines, no single researcher was able to develop a coherent hypothesis. An interdisciplinary conference provided the opportunity for scientists from many different fields to meet and share insights. The conference organizers noted that: ‘so shocking was this revelation [about the widespread observation of endocrine disruption in wildlife] that no scientist could have expressed the idea using only the data from his or her discipline alone without losing the respect of his or her peers’ (Colborn and Clement, 1992). Undervaluing Qualitative Methods Scientists tend to devalue qualitative information, viewing it as of lesser quality than quantitative evidence (Funtowicz and Ravetz, 1992). But in the face of great uncertainty such information may be the highest quality information on which to base decisions. For example, parents of children in the farming regions of Sonora, Mexico raised concerns about the impacts of pesticides on their children’s health and development. Dr Elizabeth Guillette set out to study similar communities of native Mexican farmers – one community that used pesticides and one community that did not. Dr Guillette was able to identify subtle but real differences in neurological development caused by pesticides by comparing the drawings of children in pesticide exposed and non-pesticide exposed communities (Guillette, 2003). These results were supported by other laboratory and human evidence of the impacts of pesticides on neurological development. Yet the differential effects seen in these communities would not have been captured through traditional study designs. Studying Relationships which are Easier to Study and Quantify Because of time and funding constraints we tend to study only limited, quantifiable aspects of problems, like the relationship between genes and cancer or diet and obesity, without examining the potentially more important but more difficult to prove aspects of disease such as exposure to toxic substances or impacts of urban sprawl (see Kriebel et al., 2001). The attempt to translate problems into manageable research questions means that we may get extremely precise answers to incomplete or incorrect questions – a ‘Type III’ error (Schwartz and Carpenter, 1999). A related tendency is to refine understanding and increase detail about specific substances or hazards, rather than explore new questions. While such

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increased understanding is interesting from a scientific perspective, it may also slow down preventive actions. In these cases, the search for more detailed understanding may be misinterpreted as insufficient knowledge to act and may mask what is already known about a hazard. Legal scholar Carl Cranor notes that in these cases, ‘the attempt to have more fine-grained knowledge about the risks from a particular substance may actually increase the number of mistakes made’ (Cranor, 1993). Studying the Average rather than the Vulnerable Scientists often focus research on the ‘average’ individual even though there might be populations at much higher risk due to their higher exposures, genetic susceptibility or developmental vulnerability, such as children. For example, scientists know that some chemicals, such as diethylhexyl phthalate, cause minimal effects in adult laboratory animals, but cause substantial effects in much lower doses in developing animals (Tickner et al., 2001). The areas of children’s environmental health and environmental justice have arisen, in part, because of the lack of science and policy to address the impacts of exposures on vulnerable sub-populations. Studying One Exposure at a Time Scientists generally study the direct effects of single exposures rather than exposures to multiple chemicals and other stressors – our everyday reality. For example, in the Merrimack Valley of Massachusetts, local residents were concerned about exposure from surrounding incinerators. The State Department of Environmental Protection studied each one individually and told community residents that the risk was acceptable (Massachusetts Department of Environmental Protection, 1999). However, they did not study the cumulative effects of the five incinerators in a several mile radius; the other industrial exposures in the area; or the impacts of local poverty on impacts from the exposures. In trying to develop a defensible analysis of risk, the agency neglected the multiple interacting exposures of residents in the Valley that jointly contribute to their risk of adverse health effects. While their analysis found that the risks were quite low, there is no way to know whether the risks caused by the incinerators, combined with others, would be much greater. The Implications of Limitations in Scientific Tools Used in Policy Unfortunately, the limitations in scientific methods to quantify causal relationships are often misinterpreted as proof of safety. For example, when


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initially responding to concerns about the health impacts on children and chronically ill adults of phthalates used as softeners in polyvinyl chloride medical devices such as IV bags and tubing, the U.S. Food and Drug Administration and the medical device industry stated that these substances had been used safely for 40 years without any evidence of human impacts (Phthalate Information Center, 2003). It may be that the reason there was no evidence of human disease effects is that no large studies have been done looking at these effects. In contrast, a variety of toxicologic studies identified potential hazards to human health (see Tickner et al., 2001). Biologist John Cairns has noted that scientists and policy makers often discount highly uncertain risks, while concluding that ‘Unrecognized risks are still risks, uncertain risks are still risks, and denied risks are still risks’ (Cairns, 1999). Lack of evidence is certainly not proof of safety, as this example demonstrates.

PROBLEMS WHEN TRADITIONAL SCIENCE IS APPLIED IN POLICY The regulatory system in the United States and in many other countries perpetuates these limitations in science due in part to the constant challenges that regulators face from the regulated community, politicians and others. To make their jobs easier and decisions more defensible, decision makers prefer to release seemingly precise estimates of risk and not to talk about the uncertainties underlying the numbers. In addition, they often avoid studying problems – for example cumulative effects of multiple exposures – if their tools or methods are not fully developed or might be challenged by regulated parties or others (Applegate, 2000). Uncertainty is often viewed by regulators and the regulated community as a negative aspect of science (Funtowicz and Ravetz, 1992). While uncertainty is critical to identifying new research questions, acknowledging uncertainty can weaken agency authority, by creating an image of the agency as unknowledgeable and by threatening the objectivity of ‘sciencebased’ standards which are essential to an agency’s ability to defend itself in the courts. Reluctance to acknowledge uncertainty pushes agencies to use numbers (often point estimates) as a facade to cover up what are often political decisions (see Brickman et al., 1985). The potential for challenges forces agencies to create certainty where it does not exist and to wait for more defensible proof of harm before acting, in order to avoid conflict. This fear of uncertainty can further cause problems to be structured in a way that will produce clear solutions (that is, not studying cumulative effects) (see Brickman et al., 1985, Clark and Majone, 1995). In addition,

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under uncertainty it is in the interest of those fighting regulation to convert political questions (should we act or not) into technical/scientific ones so as to delay regulation. Thus uncertainty is used strategically by the regulated community as reason to justify inaction. It is also used to as tool to minimize the importance of risk (Clarke, 1989; Abraham, 1994). The problem here is that under most regulatory approaches, while the fine points of the scientific evidence and real or manufactured uncertainties are debated, nothing is done about the potential hazards. They are considered safe in the face of lacking data and uncertainties. For example, while most Americans believe that someone tests chemicals used in everyday products and that some government agency makes sure they are safe, 93 per cent of high production chemicals in commerce, emitted into our environment and in the products we use everyday, lack some basic toxicologic data. In practice, the consequence is that lacking such data, substances are deemed safe simply by default (U.S. Environmental Protection Agency, 1998). While efforts are underway to remedy this situation for the most widely used chemicals, major gaps in our understanding of chemicals and their effects remains despite the use of many substances for over fifty years. Even when data are available, uncertainties raised about the nuances of the risk can stall action. For example, it took the Occupational Safety and Health Administration nearly a decade to finalize a standard for methylene chloride. Many of those years of debate – over a chemical known to be problematic – were focused on minutiae about how the chemical was transported through the human body and caused its toxic effects (see US Occupational Safety and Health Administration, 1997). While these debates occurred, workers continued to be exposed to what has now been deemed a potential carcinogen. This approach to environmental science is not only inefficient, it can be harmful to health and ecosystems. Indeed, if scientific research had been focused on analysing alternatives to methylene chloride in various industrial operations while simultaneously exploring the substance’s mechanism of action, these debates over toxicologic mechanism might have been avoided and workers would have been better protected sooner because debates over toxicologic mechanism would not have been the only focus of research (see Roelofs and Ellenbecker, 2003). Defenders of the current ‘sound science’ system of regulating environmental risks argue that there is no need for the precautionary principle or changes in science because uncertainties are addressed through the use of safety factors which toxicologists and risk assessors use when setting so-called ‘safe’ levels of exposure to chemicals and other agents (US Food and Drug Administration and US Department of Agriculture, 2000). It is standard practice in risk assessment to identify the level below which no


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adverse effect is observed, and then to set the safe level 10 or 100 times lower than this. But safety factors are only useful to the extent that the hazardous effects can be accurately observed and their probability quantified. We must also be confident that we are actually studying the most important effect and that we correctly identify the population that will be most affected. Recent research indicates that current safety factors may not be precautionary at all. U.S. Environmental Protection Agency (USEPA) researchers have found that many of the ‘reference doses’ (regulatory ‘safety levels’ of exposure) may in fact correspond to disease risks of greater than 1 in 1000 (meaning a probability of 1 in 1000 people exposed over a lifetime becoming ill from exposure) – clearly not safe levels given uncertainties about many chemicals and their effects and the preventability of many exposures (Castorina and Woodruff, 2003).

SCIENCE POLICY TO STIMULATE PRECAUTIONARY ACTION Given the limitations in the current approach to science used in environmental policy, we believe that it is necessary to re-evaluate scientific research agendas, funding priorities, science education and science policy if we are to support more health protective decisions under uncertainty (see Tickner, 2003a). There are two key barriers to a more precautionary and preventive approach to environmental science that could be addressed through appropriate policy interventions: (1) the limitations of current policies and court interpretations for allowing innovative science or action in the face of uncertainty; and (2) the lack of government funding for more appropriate scientific methods. Other barriers also exist, such as the lack of interdisciplinary approaches in education and efforts by regulated parties to change scientific practices. These have been discussed in depth elsewhere (see Tickner, 2003a and Kriebel et al., 2003). Limitations in Policies and Interpretations of Them There are many examples of current federal laws and executive level policies which impede the ability of regulatory agencies to act in the face of uncertainty or to experiment with new scientific methods and policy tools until fully developed and widely accepted. Many laws in the U.S. assume potentially harmful activities safe by default and require near proof of damage before government agencies can act. For example, under the U.S. Toxic Substances Control Act (TSCA), chemicals on the market prior to 1980 are considered registered and by default safe. To restrict so-called

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‘existing chemicals’ the law requires that the Environmental Protection Agency (EPA) demonstrate a significant risk to health or ecosystems in addition to demonstrating that the benefits of regulation outweigh the costs and that the action is the least restrictive to meet a particular need. As a result, the EPA has restricted less than 14 chemicals during the last 25 years under the law. The EPA’s experience in attempting to regulate asbestos in 1990 demonstrates the near impossibility for it to restrict chemicals in commerce through regulatory means. Following ten years of research, public meetings and regulatory impact analyses, in 1989 the EPA issued a final rule under Section 6 of TSCA to prohibit the future manufacture, importation, processing and distribution of asbestos in almost all products. The asbestos industry challenged the EPA’s ban and took its appeal to the Fifth Circuit Court of Appeals. In a landmark case (Corrosion Proof Fittings v. EPA 947 F 2d 1201 (5th Cir 1991)), the court all but eliminated the EPA’s ability to use TSCA Section 6 to restrict problem chemicals. Overall, the court held that the EPA had presented insufficient evidence (including risk information) to justify its asbestos ban. The court found that: (1) the agency had not used the least burdensome regulation to achieve its goal of minimizing risk, (2) had not demonstrated a reasonable basis for the regulatory action, and (3) had not adequately balanced the benefits of the restriction against the costs to industry. In its conclusions the court held that ‘the EPA’s regulation cannot stand if there is any other regulation that would achieve an acceptable level of risk as mandated by TSCA’ and that ‘EPA, in its zeal to ban any and all asbestos products, basically ignored the cost side of the TSCA equation’. Such a sharp reprimand from the court has placed a chill on any further efforts by the EPA to use its authority to restrict chemical production or use. As a result, agency officials have given up hope of being able to use their powers to regulate existing chemicals under TSCA, and instead rely almost entirely on voluntary initiatives to encourage the regulated community to take action (see Tickner and Geiser, 2003b). As can be inferred from the above example, judicial review and constant challenges have had a profound effect on how environmental agencies in the U.S. examine environmental threats and the amounts and type of evidence needed before acting (Applegate, 2000). The threat of judicial scrutiny has forced agencies to construct formal, quantitative records (von Moltke, 2000) and to make compliance with court decisions a top priority (O’Leary, 1989). Rather than risk remand, agencies prefer to develop evidence as fully as possible from the outset. This leads to protracted rule making periods (Brickman et al., 1985), results in priority placed on developing a strong scientific basis for well-established hazards at the expense of lessestablished ones, and forces agencies to rely on formal quantitative


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procedures that systematize the assessment of scientific information – namely risk assessment and the analysis of economic impacts of regulations. Because most regulatory decisions are liable to be challenged in the courts, regulatory agencies are hesitant to apply innovative new scientific tools, such as those to study root causes of disease, cumulative effects, interactions or vulnerable sub-populations, or to characterize better uncertainty and ignorance. Instead, they prefer less controversial methods that can quantify causal relations, provide precise answers, such as point estimates or risk figures, and avoid the muddling effects of uncertainty or qualitative information (Tickner, 2003a). A more precautionary approach to science may be ‘messier’, more controversial, and more difficult to defend, but this should not discourage environmental and health agencies from undertaking these challenging but necessary changes to enhance their ability to anticipate and take preventive, precautionary action on environmental hazards. Agencies must be creative and interdisciplinary in examining and addressing problems, often with a wider lens than that provided by the legislation or policies they enforce. However, Krimsky (2000) finds that a shift to a more precaution-oriented approach to assessing health effects will require restructuring of the legal foundations and regulatory framework guiding the prevention of risks. Limited Government Funding for Appropriate Science Government funding for scientific research plays a critical role in defining the types of problems and questions that are examined. Hypotheses are often formulated in ways that are feasible to test with the time and resources available. Some analysts have noted that scientific funding at the federal level for public health and environmental research is targeted toward mono-disciplinary, short-term, uncontroversial and often molecular-level research instead of holistic and integrated approaches addressing large scale, long-term problems (Krimsky, 2000). Funding agencies and sceptical peer reviewers reinforce this tendency by favouring tightly focused proposals that repeat or incrementally build upon work in wellestablished areas – such as refining mechanisms of lead or asbestos toxicity rather than examining the effects of less studied toxicants (Kriebel et al., 2001). Researchers whose work does not fall into the prevailing paradigm often have difficulties in securing funding (Krimsky, 2000). There is thus inadequate government funding for interdisciplinary, innovative and preventive environmental research. While there are no clearcut figures, we would argue that at least 80 per cent of federal funding for environmental research is focused on more and more precise characterizations of risks (problems) rather than on the identification of solutions and

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design and evaluation of prevention strategies. Of course, both types of research are needed, but risk characterization, without research on alternatives, stifles innovation and encourages inaction. Precaution can be stimulating to economic development, by promoting inherently cleaner and safer new technologies (see Ashford and Caldart, 1997 and Ashford, 1999). An additional limitation of the present funding direction is that there is a strong tendency towards research within narrow disciplinary boundaries rather than interdisciplinary research on such challenges as the life-long cumulative effects of hazardous exposure or the combined effects of simultaneous exposures to several chemicals at once. For example, the U.S. National Institutes of Environmental Health Sciences (NIEHS) has recently invested millions of dollars in research to expand the molecular-level understanding of how environmental pollutants affect health – the area of toxicogenomics.4 This investment is premised on the notion that greater understanding of how pollutants interact with the genome will help make better prevention decisions. While such an investment in long-term research is laudable, it is unclear whether the research will result in real benefits for prevention and further does not respond to the great deal of evidence to show that the effects of pollution on health and the environment can be greatly reduced by eliminating exposure to known hazards. While this work is important for understanding the etiology of disease and its treatment, there must be a better balance between molecular level research on risks and interdisciplinary research on complex risks and prevention. We believe that government should be putting a much greater share of its resources into science that is more appropriate to setting precautionary policies – with proven benefits to health and environment – and less into more speculative research such as toxicogenomics. An example of funding for more appropriate science is the area of green chemistry. While receiving only minimal government support (currently the federal green chemistry budget amounts to about as much as is spent in a two-year rodent carcinogenesis study of a single chemical), the U.S. has become a world leader in this field. Green chemistry means chemistry research on finding ways to achieve the same ‘services’ that hazardous chemicals provide, while reducing their environmental and health impacts (Anastas and Warner, 1998). There are many examples of safer chemicals and chemical syntheses being developed and implemented in U.S. universities and industries, and which deserve greater government support. In 2004, a bill was introduced in the US Congress to increase substantially the federal budget for green chemistry research to upwards of US$87 million.5


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CONCLUSIONS The idea of precaution is entirely consistent with good science and good public policy. Acknowledging the inherent uncertainty and limitations in our understanding of complex risks challenges us to develop new methods and tools to characterize these threats and focuses our attention on opportunities for prevention and innovation. We must recognize that decisions in the face of great uncertainty should be informed by science but are ultimately political. Applying the precautionary principle provides a challenge and an opportunity for environmental science. As environmental science is an applied science for informing public policy, environmental and public health scientists must engage in scientific research and education that is relevant to the nature of risks being studied and communicates information that can effectively inform decision-making processes. Applying the principle encourages scientists and policy makers to ask whether our tools and policies are sufficient to characterize and prevent environmental risks. We believe that one of the most important roles the precautionary principle can play in environmental science and policy is to encourage introspection and innovation in science, policy and technology that can lead us towards a more sustainable future.

NOTES 1. This chapter is based on testimony from a U.S. Congressional Briefing on Science and Precaution in Environmental and Public Health Policy, 24 July 2003. 2. While our backgrounds are primarily in epidemiology and toxicology, for the purposes of this chapter, we discuss environmental science in its broadest sense. Environmental science is a multidisciplinary field, and includes quite different disciplines (and their epistemological and operational biases) such as ecology, epidemiology, hydrology, environmental chemistry and so on. Based on our discussions with numerous scientists from various disciplines there is substantial interdisciplinary overlap in the types of issues about environmental science that we discuss. 3. See: www.e1.greatlakes.com/corp/news/jsp/previous_news_detail.jsp?contentfile=110303 _firemaster_550_fact_sheet.htm (accessed 21 October 2005). 4. See: www.niehs.nih.gov/nct/home.htm (accessed 21 October 2005). 5. See: www.house.gov/science/press/108/108–201.htm (accessed 21 October 2005).

REFERENCES Abraham, John (1994), ‘Distributing the benefit of the doubt: scientists, regulators, and drug safety, Science, Technology and Human Values, 19, 493–522. Anastas, P. and J. Warner (1998), Green Chemistry: Theory and Practice, London: Oxford Science Publications.

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Applegate, John (2000), ‘The precautionary preference: an American perspective on the precautionary principle’, Human and Ecological Risk Assessment, 6 (3), 413–43. Ashford, N. (1999), ‘A conceptual framework for the use of the precautionary principle in law, in C. Raffensperger and J. Tickner (eds), Protecting Public Health and the Environment: Implementing the Precautionary Principle, Washington, DC: Island Press, pp. 198–206. Ashford, N. and C. Caldart (1997), Technology Law and the Working Environment, Washington, DC: Island Press. Birnbaum, L. and L. Staskal (2004), ‘Brominated fire retardants: cause for concern’, Environmental Health Perspectives, 112 (1), 9–17. Boehmer-Christiansen, S. (1994), ‘The precautionary principle in Germany: enabling government’, in T. O’Riordan and J. Cameron (eds), Interpreting the Precautionary Principle, London: Earthscan, pp. 31–60. Brickman, Ronald, Sheila Jasanoff and Thomas Ilgen (1985), Controlling Chemicals: The Politics of Regulation in Europe and the United States, Ithaca, NY: Cornell University Press. Cairns, J. (1999), ‘Absence of certainty is not synonymous with absence of risk’, Environmental Health Perspectives, 107 (2), A1–3. Castorina, R. and T. Woodruff (2003), ‘Assessment of potential risk levels associated with U.S. Environmental Protection Agency reference values’, Environmental Health Perspectives, 111 (10), 1318–25. Clark, William and Giandomenico Majone (1995), ‘The critical appraisal of scientific inquiries with policy implications’, Science, Technology and Human Values, 10, 6–19. Clarke, Lee (1989), Acceptable Risk? Making Decisions in a Toxic Environment, Berkeley: University of California Press. Colborn, T. and C. Clement (eds) (1992), Chemically-Induced Alterations in Sexual and Functional Development: The Wildlife/Human Connection, Princeton, NJ: Princeton Scientific Publishing. Cranor, Carl (1993), Regulating Toxic Substances: A Philosophy of Science and the Law, New York: Oxford University Press. European Commission (2000), Communication from the Commission on the Precautionary Principle, Brussels, 2 February, COM 2000 (1). Funtowicz, Silvio and Jerome Ravetz (1992), ‘Three types of risk assessment and the emergence of post-normal science’, in S. Krimsky and D. Golding (eds), Social Theories of Risk, Westport, CT: Praeger, pp. 251–74. Guillette, E. (2003), ‘The children of the Yaqui Valley: precautionary science and communities’, in J. Tickner (ed.), Precaution, Environmental Science and Preventive Public Policy, Washington, DC: Island Press, pp. 321–32. Hill, A.B. (1965), ‘The environment and disease: association or causation’, Proceedings of the Royal Society of Medicine, 58, 295–300. Holm, S. and J. Harris (1999), ‘Precautionary principle stifles discovery’, Nature, 400: 398. Kriebel, D., J. Tickner and C. Crumbley (2003), Appropriate Science: Evaluating Environmental Risks for a Sustainable World, presented at Education for Sustainable Development, Committee on Industrial Theory and Assessment, University of Massachusetts Lowell, Lowell, MA, 23–24 October. Kriebel, D., J. Tickner, P. Epstein, J. Lemons, R. Levins, E.L. Loechler, M.M. Quinn, R. Rudel, T. Schettler and M. Stoto (2001), ‘The precautionary


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principle in environmental science’, Environmental Health Perspectives, 109, 871–6. Krimsky, Sheldon (2000), Hormonal Chaos: The Scientific and Social Origins of the Environmental Endocrine Hypothesis, Baltimore: Johns Hopkins University Press. Lowell Center for Sustainable Production (2003), Precautionary Chemicals Policy Initiatives in the United States, Lowell, MA, available at www.chemicalspolicy. org/repo.shtml (accessed 21 October 2005). Massachusetts Department of Environmental Protection (1999), Aggregate Impact Study for Inhalation Exposures to Air Toxics Emitted from Incinerators in the Merrimack Valley: Post Retrofit Study, Office of Research and Standards, MA DEP, January. Massachusetts Toxics Use Reduction Institute (1997), Massachusetts is Cleaner and Safer: Report on the Toxics Use Reduction Program, Lowell, MA: Massachusetts Toxics Use Reduction Institute, for more updated data see www.turi.org. McMichael, Anthony (1993), Planetary Overload: Global Environmental Change and the Health of the Human Species, New York: Cambridge University Press. Morris, J. (ed.) (2000), Rethinking Risk and the Precautionary Principle, Oxford: Butterworth-Heinemann. O’Brien, M. (2000), Making Better Environmental Decisions: An Alternative to Risk Assessment, Cambridge, MA: MIT Press. O’Leary, Rosemary (1989), ‘The impact of federal court decisions on the policies and administration of the U.S. Environmental Protection Agency’, Administrative Law Review, 41, 549–74. Päpke, O., L. Bathe, Å. Bergman, P. Fürst, D. Meironyté Guvenius, T. Herrmann and K. Norén (2001), ‘Determination of PBDEs in human milk from the United States’, Organohalogen Compounds, 52, 197–200. Phthalate Information Center (2003), Phthalates in our Lives: Phthalates in Medical Devices, www.phthalates.org, accessed 11 December 2005. Raffensperger, C. and J. Tickner (eds) (1999), Protecting Public Health and the Environment: Implementing the Precautionary Principle, Washington, DC: Island Press. Roelofs, C. and M. Ellenbecker (2003), ‘Source reduction for prevention of methylene chloride hazards: cases from four industrial sectors’, Environmental Health: A Global Access Science Source, 2, 9, available at www.ehjournal.net. Rudel, R.A., D.E. Camann, J.D. Spengler, L.R. Korn and J.G. Brody (2003), ‘Phthalates, alkylphenols, pesticides, polybrominated diphenyl ethers, and other endocrine-disrupting compounds in indoor air and dust’, Environmental Science and Technology, 37, 4543–53. Schwartz, S. and K. Carpenter (1999), ‘The right answer for the wrong question: consequences of type III error for public health research’, American Journal of Public Health, 89, 1175–80. Seedorff, Lisbet (1999), Head of Chemicals Division, Danish Environmental Protection Agency, Personal Interview, 21 May. Tickner, J. (2000), Precaution in Practice: A Framework for Implementing the Precautionary Principle, ScD Dissertation, Department of Work Environment, University of Massachusetts Lowell. Tickner, J. (2003a), ‘Commentary: barriers and opportunities to changing the research agenda to support precaution and primary prevention’, European Journal of Oncology, Library Vol. 2, 203–16, available at www.collegiumramazzini.org/links/TICKNER.pdf (accessed 21 October 2005).

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Tickner, J. (ed.) (2003b), Precaution, Environmental Science and Preventive Public Policy, Washington, DC: Island Press. Tickner, J. and K. Geiser (2003a), New Directions in European Policies, Lowell, MA: Lowell Center for Sustainable Production, available at www.chemicalspolicy.org. Tickner, J. and K. Geiser (2003b), The Promise and Limits of the United States Toxic Substances Control Act, Lowell, MA: Lowell Center for Sustainable Production, available at www.chemicalspolicy.org/repo.shtml (accessed 21 October 2005). Tickner, J., D. Kriebel and S. Wright (2003), ‘A compass for health: rethinking precaution and its role in science and public health’, Epidemiology, 32, 489–91. Tickner, J.A., T. Schettler, T. Guidotti, M. McCally and M. Rossi (2001), ‘Health risks posed by use of Di-2-ethylhexyl phthalate (DEHP) in PVC medical devices: a critical review’, American Journal of Industrial Medicine, 39 (1), 100–11. United States Consumer Product Safety Commission (1998), The Risk of Chronic Toxicity Associated with Exposure to Diisononyl Phthalate (DINP) in Children’s Products, Washington, DC: USCPSC, December. United States Environmental Protection Agency (1998), What Do We Really Know About the Safety of High Production Volume (HPV) Chemicals, Washington, DC: United States Environmental Protection Agency, Office of Pollution Prevention and Toxics. United States Food and Drug Administration and U.S. Department of Agriculture (2000), United States Food Safety System: Precaution in U.S. Food Safety Decision-Making, Washington: U.S. Food and Drug Administration and U.S. Department of Agriculture, 3 March. United States Occupational Safety and Health Administration (1997), OSHA Preambles: Methylene Chloride v. Health Effects, available at www.osha-slc. gov/pls/oshaweb/owadisp.show_document?p_table=PREAMBLES&p_id=1005] (accessed 11 December 2005). von Moltke, Konrad (2000), The Precautionary Principle, Risk Assessment, and the World Trade Organization, Winnipeg: International Institute for Sustainable Development.

4. The precautionary principle and catastrophism on tenterhooks: lessons from a constitutional reform in France Olivier Godard1 INTRODUCTION The precautionary principle (PP) has been introduced and progressively acknowledged in environmental law for more than fifteen years, but to a differing extent in international, European and domestic law. Outside Europe, many countries still refuse to give it legal effect, although it is reflected in a number of international agreements, even in the World Trade Organization (WTO) Sanitary and Phytosanitary (SPS) Agreement (Noiville 2000). Within the European Union, the PP has been a legal norm for environmental protection since the Maastricht Treaty in 1992 (Article 174(2)); the EU regulation of food safety in 2002 has confirmed its relevance in the field of public health, something that had already been established by case law, at least since 1998 in the context of the BSE crisis. During the same period of time, sound elements of doctrine had been progressively set up by academic work and within policy circles. Official policy statements eventually legitimized this doctrine at the EU level. Stepping stones in this regard are the Communication of the Commission in February 2000 and the Resolution of the European Council held in Nice in December 2000. In spite of these achievements, debates about the conceptual structure of the PP and the conditions and means to put it into practice have not stopped. Opposite expectations arose and fed controversies between experts and in the public debate. Thus, since the subsidiarity principle has become a key feature of the European story and was stressed by recent debates on the future of EU institutional working, it is wise to raise the issue of sovereignty in relation to the PP. The questions are: what could be the contribution of legal development within internal legal frameworks of European countries to the future understanding of the PP? In particular what are the 63

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consequences if a country gives the PP a constitutional value, as France did in March 2005? This chapter offers a broad range of reflections on the PP based on the French debate and constitutional reform. Those reflections are informed by economic thinking and political philosophy but also take due count of legal developments and debates about the evolution of the law. Three main points will be addressed: 1.

2.

3.

Regarding the right conceptual content of the PP, there has been for years a sustained confusion between two concepts: the Precautionary Principle, which has been validated by EU and French public authorities, and what I call the Principle of Abstention. Dissipating the confusion between both concepts was a key challenge of the debate that took place in France and one of the motives of the inclusion of the PP as part of constitutional reform (first section). The French constitutional reform is a useful case study for at least two types of lessons. First, due to the prevailing coexistence of several concepts behind the same wording, the fear of an uncontrolled extension of an ‘arbitrary’ interpretation of the PP by courts and public bodies has been an important input into the public debate. Here ‘arbitrary’ mean several things: ‘inappropriate’, ‘irrational’, ‘unpredictable’, ‘moving away from the intent of legislators’, ‘distorted judgement under influence of public opinion’ or ‘damaging basic liberties’. This situation is thought provoking in relation to the type of arguments to be deemed acceptable in public debates, particularly when these put forward risks for society that could derive from constitutional changes. Afterwards I will consider the consequences of this constitutional upgrading of the PP, although I acknowledge that this question is only relevant for countries that, like France, have written constitutional laws at the top of their legal structure (second section). Since a key feature of the French reform is to stress the will to preserve a sovereign control on the ways to implement the PP and promote risk management, additional insights are provided about the links between the PP, sovereignty, the EU and international coordination in section 3.

A brief statement is necessary regarding the terminology in use in this chapter. It concerns the word ‘risk’. In a classical regulatory framework such as the 2002 EU regulation on food safety, ‘risk’ ‘means a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard’ (Commission of European Communities 2002). In the context of the discussion of the PP, this definition cannot hold.

Lessons from a constitutional reform in France

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When facing scientific uncertainty, there is no objective basis to define meaningful probability distributions. So, with the PP, we deal with hypotheses related to possible hazards or threats, without reference to the idea of computable probabilities. This is what I name ‘potential risks’ in this chapter.

1. THE PRECAUTIONARY PRINCIPLE AND THE PRINCIPLE OF ABSTENTION: CONTRASTING THE TWO CONCEPTS Two distinct concepts are often confused (Godard 1997; 2003; 2005). Firstly, there is the PP that necessitates taking an early, but proportionate, account of potential risks or hazards, in spite of remaining scientific uncertainty. A typical definition is that ‘lack of full scientific certainty should not be used as a reason for postponing effective and proportionate preventive actions . . .’. When compared to the standard concept of prevention designed to address known hazards with known probabilities of achievement, the main and original contribution of the PP to risk management is to set up a new time schedule regarding the link between action and scientific development. Then the PP provides guidance about the measures that can be taken in such circumstances of scientific uncertainty: they have to be chosen from actions ranging from scientific observation and research, information to the public, targeted incentives and administrative procedures for authorization to a provisional ban on the particular risk-generating technology or product. The key reference for assessing the appropriateness of such measures is the concept of proportionality. This concept will be detailed below. In fact, in relation to the general issue of proportionality of measures, the PP has this in common with the usual concepts of prevention such as are applied to road transportation or chemical hazards, since prevention does not imply a commitment to a zero damage goal. In this regard the PP certainly meets specific difficulties when the scientific background is not well established, being undermined by various sources of uncertainty. But uncertainty does not alter the basic requirement of proportionality; it changes the means to reach a reasonable judgement on proportionate measures. It should be stressed that this ‘early but proportionate’ characterization of the PP is the concept explicitly supported by European legal doctrine (Commission of European Communities 2000; European Council 2000), and also the French law since 1995 (Law 95–101), reinforced in 2005 by the constitutional Charter of the Environment2 (Sénat 2004). Secondly there is the Principle of Abstention (Godard 1997; Godard et al. 2002). This apparently attractive rule demands the prohibition of any

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new activity, product or technology that could generate risks, known or still unknown, as long as these sources have not been scientifically proven to be totally safe. Under the cover of the PP, this principle has been backed by some NGOs (Greenpeace France 2005). It is linked to the (wrong) idea that the main characteristic of the PP is a reversed burden of proof and that proof of no-risk should be given.3 The Principle of Abstention is the natural outcome of a catastrophist approach to risk management. Here I define catastrophism by three components. It implies first a way of dealing with scientific uncertainty by focusing on a worst-case scenario. Then it implies making a decision to assume that the worst-case scenario will certainly occur if preventive action is not taken. Thirdly it assigns decision makers the goal of absolute prevention of this worst-case scenario. Catastrophism systematically favours the most radical measures to ensure that the envisaged scenario will not happen. Hans Jonas’ book The Imperative of Responsibility (1984) offers the often-quoted philosophical foundation for this approach. In this book Jonas argued that uncertain but possibly apocalyptic outcomes (the physical or moral end of humanity) should be avoided at all costs. No idea of probability or positive counterparts (various types of benefits) of the activities or technologies that would bear this apocalyptic outcome as a possibility should be taken into account. According to Jonas, this absolute moral imperative implies that any nondismissed possibility of an apocalyptic outcome should be absolutely avoided, however uncertain it may be. The problem with this rule is that under scientific uncertainty and early consideration of possible threats, with no clear scientific limit on the worst-case scenario other than scientific imagination, catastrophism unavoidably leads to the Principle of Abstention (Godard 2003): the requirement to prove the absence of possibility of an apocalyptic result becomes the requirement to prove the absence of damage to the environment and human health. Figure 4.1, adapted from Godard (2003), shows the basic difference between the PP and the Principle of Abstention. On the vertical axis OY is the time of scientific development in relation to a given hazard; at the top are ‘known hazards’ (y9); at the bottom is ‘informed ignorance’ (y1), that is ignorance that remains once all practical investigations based on existing knowledge have been achieved. Between them there are various degrees of emerging knowledge pertaining to hypotheses of risks, from very plausible but still not proven hazard hypotheses to non-dismissed scientific conjectures without any specific substantive empirical or theoretical element of support. On the horizontal axis OX, are all the possible preventive actions that could be taken. They are ranked according to their decreasing impact on personal and economic freedom (x1 is prohibition; x7 is scientific observation).


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Time of scientific development: state of knowledge of potential hazards Y y9

Known risks

The main drive of the PP for the EU doctrine and 1992 Rio conventions

Potential hazards y3

The driving idea of the PP for lay people and supporters of the Abstention principle y1

Ignorance

O

x7 x1 X Research Watch Provisional Incentives and Administrative Public Strict Information Prohibition Suspension restrictions of permits usage () Decreasing severity of preventive actions ()

Source: Godard (2003).

Figure 4.1 Two concepts for the PP: early account of potential hazards versus more severe precautionary measures Generally speaking an action justified by the PP can be identified both in terms of its timing (yj) and its content (xi) as A(xi,yj). For example banning any production and use of asbestos was effective in France from 1 January 1997. It was a strong measure (prohibition: x1) taken very late (y9) since first observations of health effects of asbestos for workers were made in the early years of the 20th century and the age of precaution should have given way to the age of prevention around the nineteen-sixties (European Environment Agency 2001, pp. 52–62). As said before, the EU doctrine of the PP requires first and foremost a change in the timing of preventive action. The graphic translation is

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a downward move along the vertical axis, for instance from y9 to y3. Meanwhile, if it is the case that there is complete ‘informed ignorance’ – nothing has been found but it cannot be excluded that some hazard or damage will be discovered in the future in relation to a technology or a product – the PP is not relevant and gives way to general caution, for example, by setting a general biowatch. To trigger the PP, potential hazards have to be identified as such on the basis of existing scientific work or empirical observations. The PP can only embrace those potential hazards for which there is a minimum threshold of scientific content and consistency, y3 by convention on the figure. In contrast to this understanding of the PP, the conception put forward by certain lay people and environmental activists, understands it in terms of a horizontal move on axis OX, for instance from x7 to x2. For these commentators the PP requires the taking of more severe measures than previously felt as sufficient under standard prevention policies; it comes to an overbid in caution. This figure raises the question of which relationship should be established between these two conceptually independent moves, that is between the content of preventive measures and their timing under different levels of scientific uncertainty and consistency. For the eradicative approach, which ultimately tends to Abstention, precautionary actions should be more severe and broader in scope in cases where scientific consistency is lower, that is where the scientific background is weakly supporting hypothetical risks but cannot dismiss them. Following this view, the earlier that a decision is made to address hypotheses of risks, the more uncertain is the scientific landscape and thus the higher is the need for more severe measures to be taken. This leads to the unacceptable outcome that, near the stage of ‘informed ignorance’ about the existence of possible threats, public authorities should forbid any new action (new technology, new product) (see Box 4.1). In contrast, the French and EU doctrine of the PP is framed by the idea of proportionality. The less advanced scientific knowledge is, and the weaker scientific support of hypotheses in relation to a risk is, the less severe restrictive measures should be, all things being equal regarding the order of magnitude of seriousness of potential damage. When hypotheses on some possible hazards are still at a very early stage of formulation, only scientific observation and research are relevant. The 1999 French report to the Prime Minister on the PP had taken the same line of argument when asking for a threshold of scientific plausibility to be reached before restrictive measures could be taken regarding a potential risk (Kourilsky and Viney 2000, p. 42–43). This position has since been confirmed by French and EU case law.4


BOX 4.1

THE BIAS OF A POSITIVE FEEDBACK OF EARLINESS ON PERCEIVED SEVERITY OF RISKS

With an inappropriate framing of assessment, described below, a bias arises that automatically makes perceived seriousness of potential damage a function of earliness of risk consideration. Under this inverse relationship, early consideration of a risk results in a higher chance of it being perceived as potentially catastrophic and then calls for the most severe preventive measures. This leads to the search for zero risk and the PP is then reduced to a Principle of Abstention. The inappropriate framing of assessment that generates this bias can be traced back to two axioms: 1.

2.

An activity or technology that could generate risks is only assessed for its potential damage.‘Benefits’ of any sort are not considered. Hence, at best, the characteristic value is zero (harmlessness). Any hypothesis of potential exposure to a potential hazard is said to be valid if it has not been dismissed by science, without making any distinction regarding the level of scientific consistency of hypotheses.

Then the bias comes to life. The earlier potential risks are considered in the process of scientific development, the less we know about them, the more unknowns and questions without answers increase, the more possibilities multiply that cannot be dismissed. Since only potential damages are considered, and the best characteristic value is zero, opening up of possibilities can only happen on the side of seriousness of damage. When scientific knowledge is very preliminary, every activity could be suspected to be potentially catastrophic since no hypothesis of catastrophe has been dismissed at this stage. On the basis of the second axiom, the catastrophic scenarios should be held valid. Then faced with the announced possible catastrophe, the obligation to take it as certain in order to implement preventive measures leads to the adoption of the most precautionary and severe measures, which consist in prohibition.

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To restore a proportionate approach to the PP the two axioms have to be changed: 1. 2.

Assessment of new activities and technologies should consider both possible damages and benefits. The practical effect to give to hypotheses of risks cannot be the same whatever the level of scientific consistency of those hypotheses; other things being equal, preventive measures should be less severe as hypotheses of risks are weakly supported by existing scientific knowledge.

Source:

Godard (2003).

Why the Principle of Abstention and Reversed Burden of Proof are Wrong Benchmarks I have stated that the Principle of Abstention and the reversed burden of proof are dead ends. Various reasons justify such a position (Godard et al. 2002; Godard 2003). Let us note first that the attribution of burdens of proof is not intrinsic to the PP. Take the position of the EU Commission (2000). It refused to adopt a systematic rule regarding the ‘burden of proof’, advocating a pragmatic approach depending on prevailing procedures of authorization. Beyond that, the main point of discussion concerns the matter of proof. Several points have to be made against a strict understanding of the ‘reversed burden’ thesis. First, due to the dynamic nature of scientific knowledge, there are always unresolved uncertainties at any given time and it is logically impossible to prove that a new product or technology will never be a future source of damage. Moreover, it is not scientifically possible to prove a negative – this argument echoes Popper’s argument about falsifiability (Popper 1953): the absence of negative results of a falsification test is not a proof of the truthfulness of a statement; the lack of evidence to prove the existence of a risk does not mean that the risk does not exist. Here it is the very requirement of scientific proof of the non-existence of a potential risk that leads to a dead end, whereas the reference to such scientific evidence is legitimate for known risks approached with appropriate tests. Last, if taken seriously, the Abstention Principle implies a general norm of no damage. Such a state of affairs is quite impossible to reach due to limited resources and economic scarcity. Resources mobilized to reach a state of no-damage at certain places or for some topics have an opportunity cost and are no longer available to address other risks. Hence many


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policy issues in the field of environmental and health risk management come to a trade-off of risk against risk. This situation of risk against risk is all the more pervasive when the risks considered are still hypothetical and potential: by definition, hypotheses of risks are more numerous than those that could ultimately be revealed to be real risks, and the more so if such hypotheses are considered at an early stage. Due to the logical inconsistencies of asking for definite proof of harmlessness under circumstances justifying the use of the PP, some authors (Ewald, Gollier and De Sadeleer 2001, pp. 47–48; Boy, Charlier, Rainelli and Reis 2003, pp. 1301–1302) have suggested attenuated forms of requirements pertaining to what is to be proven. One proposed way out is to switch to an approach to safety that would only be based on the proof that current tests for known hazards have been passed; it is sometimes supplemented by the additional demand to document the search for potential hazards (scientific research and information). In the first case, agents just have to prove that they have used ordinary, regulatory tests, those that set the level of due diligence in the concerned professions (engineers, physicians, biologists and so on). In the second case, agents also have to take the initiative and to bear any cost pertaining to developing science and information linked to the suspect product or technology. Whereas these requirements may contribute positively to a general framework of risk management, we may question the idea that they provide an adequate or sufficient basis to implement the PP. Here are the reasons why. First, restricting information taken from science to those accepted results or statements that have already been established and are no longer hypotheses would strongly limit the scientific information taken into account and imply ignoring all the scientific elements of understanding included in the interval between full ignorance and fully validated scientific knowledge. This restriction cannot provide a sufficient basis to take precautionary measures. It would be a strange result to push the PP back to the standard approach to prevention, reserved to tackling known risks. The second is linked to the relative capacities of various actors to gather information on risks. According to a standard convention of economic analysis, those who generate risks are assumed to be those who know those risks the best. They should then be charged with producing the scientific information needed. However because of asymmetry of information, this solution raises a standard Principal-Agent issue and is exposed to a significant risk for the Principal to be captured by agents through scientific expertise. Public authorities can create a new obligation of communicating any private information about suspected risks for consumers as affirmed by the EU regulation on food safety (Commission of the European Communities 2002, Article 19–3), but it is not enough to set incentives

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to develop research aimed at identifying and assessing potential risks. Moreover, this informational assumption has to be challenged in many cases. If agents who generate the risks are in a good position to know the sources of commonly known risks, they are not in such a good position to identify possible risks for the environment or health. This is all the more true as those risks are collective and concern widespread people or places. For instance there is no reason why a French producer of cement should be the most informed on the risks that climate change will induce for the lowlands of Bangladesh. Thirdly, whatever the context of access to information, there is a critical issue of credibility and transparency of expertise. It should be remembered that recent food and sanitary crises (AIDS, BSE, asbestos and others) led to distrust in France and Europe because expertise was revealed as, or was suspected of, not being independent but influenced by commercial, industrial or national interests beyond the care for public health. If producers are the main class of agents who generate risks for society through their technological choices and the products they put on the market, minimum requirements of credibility of scientific expertise are that it is organized at a good institutional distance from these agents: thus for example the institutional reform introduced in France in 1998 with the creation of new independent public agencies responsible for developing scientific expertise in the safety of food products, medicines and environmental conditions. On the same lines, European regulation 178/2002 created the European Food Safety Authority. For all these reasons (irrational limitation of the scientific information basis, threat of capture, lack of informational capabilities, lack of credibility of an expertise made or suspected to be biased), it would not be wise to focus on standard tests conceived on the basis of stabilized science and to ask that risk research and analysis depend exclusively or mainly on those who generate risks. Meanwhile it would be reasonable to ask them to take part in alert procedures and the financing of research and expertise but, for the latter, without responsibility for its management. These organizational reasons make it unappealing to reverse the burden of scientific research and expertise pertaining to hypotheses of risks. Two conclusions result from the analysis. First, the PP does not ask to reverse the burden of proof and it would not be wise to do so. Second, confusing the PP with the Principle of Abstention would be particularly damaging for the quality of intellectual debate and, more importantly, the quality of public decision making. These two features have been confirmed by the French debate on the constitutional Charter of the Environment.


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2. THE PRECAUTIONARY PRINCIPLE AS A CONSTITUTIONAL NORM IN FRANCE: A DIFFICULT PUBLIC DEBATE France is the first EU Member State that has incorporated the PP in its Constitution, via a dedicated Charter of the Environment. The project of the Charter was a personal initiative of the President of the French Republic following his political programme announced before the 2002 presidential elections. A national Commission was set up which was chaired by the anthropologist Yves Coppens (Coppens 2003) and composed of persons coming from various circles (business, local political representatives, physicians, trade unions, scientists and so on). Its work was prepared and fed by two committees, one for science, the other for legal aspects, and by an extended process of consultation including formal local debates in ten regions of France. This Charter project encountered strong opposition from various circles. The polluter-pays and the precautionary principles were the hottest targets. In March 2003 the Academy of Medicine and the Academy of Science released opinions asking to avoid including the PP in a constitutional text because of the potential catastrophic consequences for scientific development, technological innovation, public health, economic welfare and even environmental protection (Académie nationale de médecine 2003; Académie des sciences 2003). In May 2004, the Académie des sciences morales et politiques released an opinion expressing strong reservations about the Charter, specifically targeting article 5 devoted to the PP and article 7 declaring the right of citizens to access to information and to take part in the preparation of decisions, which they saw as an attack against the proper operation of a representative democracy (2004). The French leading business organization (MEDEF) argued that there existed a basic contradiction between the PP and the need to promote technological innovation in order to improve economic competitiveness (Seillière 2004). Liberal and libertarian right wing movements expressed the view that the PP would violate individual freedom because it legitimized the exercise of arbitrary state power and the manipulation of the latter by ideological movements and uninformed public opinion. The PP was even said to allow anybody to make legal accusations against business firms or physicians for imaginary threats without having to bring any evidence. It would then ruin the rule of law and, because of legal insecurity, prevent market forces bringing their benefits at the same time (Lepage 2003; Ewald 2004). More moderate critics pointed to the fuzzy definition of the principle and the poor understanding that politicians, the media and lay people had, resulting in the principle being wrongly characterized as guaranteeing extremely cautionary

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measures in order to achieve hazard eradication (zero-risk target). In other words they were concerned that the principle would be understood as a Principle of Abstention. On the opposite side, the Economic and Social Council released in March 2003 an opinion overly favourable to the Charter of the Environment project and specifically to the PP, but with a general recommendation to extend the scope of the Charter to sustainable development (Martinand 2003). The main federation of environmental NGOs, France-NatureEnvironnement, jointly with the main consumer organization (UFC-Que choisir), backed the project, considering that in spite of limits and imperfections it would result in the growth of collective consciousness regarding environmental issues and provide a legal resource to be mobilized in actions against unjustified, dangerous and wasteful types of development. One important trade union, CFDT,5 also decided to support the Charter (CFDT 2003). Within political parties there were internal divisions on the issue and without the strong political weight of the President, the main party of the governmental majority would have voted against the PP in the Charter. The Charter received its final vote from Congress on 28 February 2005. The full text of the core of the Charter is given in Box 4.2.

BOX 4.2

« Art. 1. « Art. 2. « Art. 3.

« Art. 4.

« Art. 5.

THE CORE OF THE CHARTER OF THE ENVIRONMENT INCORPORATED INTO THE FRENCH CONSTITUTION Every person has the right to live in a balanced environment that does not harm his or her health. Every person has the duty to participate in the conservation and improvement of the environment. Every person must, under the conditions defined by law, prevent damage that they are likely to cause to the environment or at least limit its impact. Every person must contribute to the repair of damage that they cause to the environment, under the conditions defined by law. If the occurrence of damage has the potential to affect the environment in a serious and irreversible manner, even though there may be scientific uncertainty, the public authorities should make sure, by applying the precautionary principle and within the limits of their attributions, that procedures for evaluation of the risks are


« Art. 6.

« Art. 7.

« Art. 8.

« Art. 9. « Art. 10. Notes:

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followed and that provisional and proportionate measures are taken in order to ward off the damage. Public policies must promote sustainable development. To this end, they reconcile protection and development of the environment with economic development and social progress. Everyone has the right, under the conditions and limitations defined by law, to have access to information concerning the environment that is held by the public authorities, and to participate in the preparation of public decision making that has an impact on the environment. Environmental education and training must contribute to the exercise of the rights and duties defined in this Charter. Scientific research and innovation must contribute to the protection and development of the environment. This Charter will guide France’s actions in Europe and internationally.

Unofficial translation from the French text.

On Acceptable Arguments in a Public Debate on a New Public Constitutional Rule Since the fundamental controversy of whether the PP should be included in the Charter has now been resolved, it is interesting to reflect on the conditions of debate for such a constitutional reform. The point under examination is to elucidate whether, among all arguments put forward from different sides, something can be said about acceptable and unacceptable framings of arguments to discuss a constitutional text. Here the matter lies at the highest level of hierarchy within the legal order, one that will constrain the future democratic life of the country and the autonomy of its Parliament. Taking account of the sustained conceptual confusion surrounding the PP, and fears that it would lead to arbitrary, unwanted and even catastrophic side effects on society, one of the justifications given for the constitutional reform was to bring a conceptual clarification at the highest possible level in the legal system and so to limit possible future occurrences of arbitrary or unwanted interpretations that could come from domestic and EU jurisdictions (Perben 2004; Kosciusko-Morizet 2004).

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In this regard, it should be noticed that the most prominent critics of the PP did not target its explicit rationale. Rather they criticized it for creating unintended side effects due to mistakes, deviations or perversion of legal rules that would be facilitated, so it was claimed, by a constitutional text. They put their arguments in terms of risks that the PP is supposed to generate for society and their most cherished values (freedom, competitiveness, social progress and so on). This specific framing of issues strikingly echoed the intellectual debate raised by risk management and the relevance of the PP to prevent environmental or health risks. It is thus possible to gain lessons from the previous conceptual clarification of the PP to enlighten the proper framings of public debate raised by the project to acknowledge the PP as a constitutional value. Prominent critics used a catastrophist type of argument, whereas they rejected any form of catastrophism when environmentalists used it. They imagined possible catastrophic scenarios as a result of the adoption of the PP and considered that such threats, independently of any consideration of plausibility, should suffice to dismiss the PP as a constitutional norm. So debates about the PP in the French Constitution lead us to wonder how to deal with unintended side effects of a constitutional reform and whether catastrophism, as such, is an acceptable way to discuss such a project at all. Some consideration of Jonas’s approach is useful at this point. He introduced a dichotomy between standard criteria for addressing ordinary situations of risk and the specific maxim for preventing apocalyptic outcomes: avoid at any cost any action for which the possibility that it could have an apocalyptic outcome at one moment of human history cannot be dismissed. Can we legitimately trace here the same sort of separation line between a proportionate approach to decisions about ordinary laws and a catastrophist framing to decisions about constitutional reform? Catastrophism can be proved to be an irrational framing in many ways. At a first level, we have already tested the decisional properties of this framing for managing technological risks. The development of any technical innovation could include a catastrophic scenario. Taking this as a certain outcome if no prevention is taken would result in the banning of the technological development under consideration. As this argument would affect all innovative technologies, there would be a general paralysis of innovation. This outcome could give birth to a scenario cumulating in serious social problems and increased pressure on environmental resources because of increasing poverty of certain groups and because technical progress that regularly allows an increase of productivity of natural resources usage would be stopped. In other words, the consequences of the catastrophist approach to risk management could also be a catastrophic scenario. According to the same rule of catastrophism, this possible


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outcome should be taken as certain at the moment a policy is made. The conclusion would then be for public decision makers that they should avoid this catastrophic scenario by promoting the innovation under consideration. The overall result of using catastrophism as a social framework of assessment of technological risks would be huge inconsistency: it would recommend one thing (rejecting technological innovation) and the opposite (promoting technological innovation). Adopting catastrophic thinking locks us in a double bind. At a second level, we can use a reflexive test, that is, testing catastrophism against itself. What would be the outcome if we apply the catastrophist framing to choose between the PP and catastrophism as a social framing for managing risks? Unsurprisingly, we find that catastrophism leads to inconsistent choices since it simultaneously selects and rejects itself, since a catastrophic result cannot be precluded for each alternative. The inconsistency of catastrophism is reflexive. So it does not fulfil the minimum requirements expected from a decision criterion. One way out could be to leave aside certain elements of the catastrophist framework and consider some comparisons across the various catastrophic scenarios derived from each alternative in order to choose the least catastrophic one – the maximin criterion.6 The rationale for decision making would then switch from an imperative of avoiding catastrophic results to a more realistic criterion of choosing the option bearing the least severe catastrophic potential. Such a solution would only be achievable if catastrophic scenarios could be assessed in the same framework so that they could be made comparable and clearly differentiated by their magnitude. Having in view a constitutional reform aimed at incorporating the PP, it would then be necessary to compare catastrophes that could derive from the two options under consideration: making the reform or rejecting it. As far as all possible states of the world and society under each option are not fully identified, this comparison cannot be reliably achieved. The conclusion imposes itself: attenuated forms of catastrophism (maximin) will not generally provide a means to overcome indecision and contradiction. Being intrinsically flawed, catastrophism cannot be accepted as a valuable framework to develop arguments in a public debate for a constitutional reform. All the arguments putting forward fears about the possible catastrophic unintended side effects of a constitutional acknowledgement of the PP are not sufficient reasons to reject the incorporation of the PP into the Constitution. This is all the more true as the envisaged unintended side effects are not a necessary consequence of the PP, but contingent ones resulting from misunderstandings and mistakes made by managers of business firms, physicians, politicians or courts.

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In contrast, let us apply the same reflexive testing procedure to the PP itself. Since it does not aim to eradicate all risks and does not pretend to offer a guarantee of no risks, the prospect of unintended side effects is not by itself a sufficient motive to reject it and then to reject the project of constitutional reform. The whole issue has to be considered under the light of proportionality. In this regard, the seriousness of anticipated damage, the benefits resulting from the action under consideration and the scientific consistency of hypotheses of risks should be balanced. Here, the hypothetical risk that, as a consequence of the constitutional incorporation of the PP, a jurisdiction makes a wrong interpretation of the PP and unduly stops some technological development should be matched against, on one side, the weak plausibility of a systematic mistake by courts of different levels, and on the other side the benefits that the constitutional reform could provide in reducing the chances of irreversible environmental damage provoked by inappropriate laws or public decisions. As a conclusion, if we apply the PP to itself, as is sometimes suggested, we see that it does not generate internal contradictions between its rationale and its recommendations for such things as constitutional reform. Neither does it reject the particular reform which acknowledges it a constitutional value. Implications of a Constitutional Status An important question to consider now is whether the incorporation of the PP in a national constitution changes its nature and content regarding domestic law and its relation to European law. This question is directly raised by the French initiative. Article 5 of the Charter, relative to the PP, clearly attributes the responsibility of organizing the implementation of the PP to public authorities and makes it compulsory for them to organize the assessment of potential risks. These two requirements are important steps. The same article is the only one in the Charter having direct legal force: it does not need support from additional laws and regulations to be enforceable. This means that the PP can be mobilized in legal procedures by anyone wanting to defeat a public decision in the environmental field, provided that the litigants prove that a public authority, in assessing risks or taking precautionary measures, has not acted properly, that it has not followed legal procedures or has made a manifest error of assessment. This ability to use the PP in administrative courts was a matter of concern in the Parliamentary debates over the Charter. First, it has been said that to give direct force to the PP in the field of the environment would decrease the power of the Parliament as an expression of public will; it would also give administrative judges a competency in relation to the


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interpretation of the Constitution, which should have been reserved to the Constitutional Court. These issues raise a fundamental point about which public institution deserves to be ultimately in charge of defining the content and requirements of the PP and, beyond, of risk management. The argument put forward by opponents was that the Parliament, not courts, should keep the main responsibility for defining the benchmarks of risk management. Second, some commentators feared that direct enforcement could give the PP an effect on criminal law liability and increase tendencies judicial regulation of social relationships at the expense of all persons taking responsibilities (managers of firms, local representatives, physicians) and social well being. Third, due to the specific text of article 5 of the Charter (see Box 4.2), introducing the PP in the Constitution would make it a general principle of law, said some MPs, beyond the environmental field that delimits the relevance of the Charter. Such a general principle would not be defined since the Charter only makes it explicit what public authorities should do when applying the PP in the field of the environment. This situation would open the door to unwanted extensions of the PP in terms of content and fields of implementation, well beyond environmental issues, for instance medical care, business risks, military defence and so on. This would be like opening Pandora’s box. Facing these objections, ministers and MPs’ rapporteurs in charge of defending the project have stressed several points (Perben 2004; KosciuskoMorizet 2004; Bizet 2004; Gelard 2004). First, as delineated by the Charter, the PP will be a constitutional principle only for environmental issues; health hazards will be concerned inasmuch as they depend on environmental factors. Second, a constitutional law has no effect by itself on criminal law. Criminal offences have to be precisely identified and designated by a criminal law. As such the new status of the PP has no effect on criminal law. Moreover article 5 explicitly delimits the direct responsibility of looking after the implementation of the PP to public authorities. Last, there were two main reasons why direct force has been given to article 5. The first is the will to reduce the autonomy of French case law in interpreting the PP. The previous situation had given a broad autonomy to judges in interpreting the PP in France. The second reason is to ensure that the requirements of the Charter of the environment have precedence over any case law and interpretation derived from international or European law. The latter argument is related to the issue of sovereignty of Member States of the European Union. It deserves specific treatment.

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3. THE PRECAUTIONARY PRINCIPLE AND THE SOVEREIGNTY ISSUE The Meaning of the French Reform for EU and International Law In case of conflicts between legal norms of different orders, the French Constitutional Court acknowledges that treaties and European laws have a superior value to domestic ordinary laws, but not to the Constitution of this country (Kosciusko-Morizet 2004). Each time a new treaty was proposed and points of conflicts were identified between the present state of the Constitution (text and case law) and EU or international commitments, it was necessary to amend the Constitution before the treaty could be ratified. If a clear hierarchy of legal norms were in place in favour of Community law, such amendments would not have been necessary. Putting the PP into the French Constitution and giving it a direct legal value ensures that, in case of conflict between French law and EU law or international agreements, according to French law, the French concept of the PP would have precedence. This motive has been explicitly put forward by the rapporteur of the Charter project before the first Chamber of Parliament (Assemblée nationale) (Kosciusko-Morizet 2004, pp. 35–36). Here lies a critical and sensitive point. Admitting this statement as a true image of the legal situation prevailing in 2004, would it still be true if the Treaty establishing a Constitution for Europe comes into force? Apparently, article I-6 of the Treaty project, which reads ‘The Constitution and law adopted by the institutions of the Union in exercising competences conferred on it shall have primacy over the law of the Member States’, introduces a new hierarchy within legal structures. In fact, it would be the case only under certain conditions and limits. The 2004 opinion of the French Constitutional Court about this treaty stressed that, in spite of the title ‘Constitution’, this text is still another treaty and the status of the EU is not changed to a federal state. For this Court, the French Constitution remains on the top of the domestic legal order (Conseil constitutionnel 2004a). The explanation is as follows: the legitimacy of EU law and particularly of this new treaty comes from the consent of Member States to delegate part of their sovereignty. This delegation is bounded by the terms of the consent, which correspond to the concepts and interpretation embedded in national constitutional orders. EU law is not opposable to those French constitutional rules that are inherent in its fundamental structures, those that touch explicit and specific French constitutional rules (Conseil constitutionnel 2004b; Mazeaud 2005).7 Examples given are the principles of secularism (laïcité) of the French Republic or equal access to public employment. This analysis is the view developed by the higher-level law authorities in France.


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If it happens that the European Constitution comes to life, cases of conflicts will identify the extent to which this view is shared in Europe. Let us make explicit the implications of this French view regarding the PP. Assuming that at some future time EU institutions gave an interpretation of EU law that was at odds with the concepts forming the basis of the delegation agreement, there would be a situation in which the consent of the French people had been violated; it would then be the EU legal position that would be in breach of its own legitimate foundation at the same time as it would breach the French constitutional order. Since the French constitutional text regarding the PP (article 5 of the Charter of Environment) is both explicit and more specific than any mention in past or prospective EU treaties,8 it is the French concept that would have to be enforced on the French territory for environmental matters. Though they presently share the same basic concept of the PP compared to the Principle of Abstention, there are nevertheless some differences between EU and French constructs. First the EU concept relevant for the environment is not defined by a treaty, but has been elaborated by case law and administrative thinking. These sources can evolve significantly. Second, the French concept is more restrictive than the EU one regarding the field and conditions of implementation: the only field explicitly acknowledged is the environment,9 and potential damages feared to affect the environment have to be severe and irreversible. Third, it puts aside any idea of there being a legal obligation to achieve a given outcome and limits the obligation of implementing PP procedures for environmental issues to public authorities (national government, national civil service and local governments). Lastly, the French concept of proportionality is broader than the EU one, which is mainly focused on restrictions to trade (Gonzales Vaqué et al. 1999). As a conclusion, the deeper implication of incorporating the PP into a national Constitution as in France is to provide governments a means to ensure a sovereign national control on interpretations of international and European norms that are not yet stabilized. This solution establishes an interesting equilibrium in multi-level governance. In any case, the story of the PP in France reveals that it would be an oversimplification to reduce the links between sovereign action of national states and international law to a simple hierarchy of norms. The Ambivalence of the Precautionary Principle, Between Enhancing International Cooperation and Reinforcing National Sovereignty Two opposite uses of the Precautionary Principle In the context of international relations the PP has been playing two opposite roles. First, it has been used to promote international cooperation. Examples

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can be found in the ministerial agreements to protect the North Sea and in the convention adopted by the international community regarding global climate change at the Earth Summit in Rio de Janeiro in June 1992. In the latter, states jointly acknowledged the necessity to take preventive action despite scientific uncertainties, and agreed a common framework of action. Here was the foundation for a further binding agreement, the Kyoto Protocol (1997).10 Second, the PP has also been used by states to derogate from previously agreed ordinary international or community rules, specifically trade rules. In these circumstances the PP is taken as a justification for a state taking unilateral measures, such as blocking trade flows of some specific products at borders. A typical example in the EU is the so-called ‘mad cow crisis’ in Europe in March 1996, when national governments and the Commission decided to put UK beef exports under embargo, a measure that directly opposed the principle of freedom of circulation of goods within the European area. This usage is still more evident when France maintained the embargo against UK beef exports in Autumn 1999 in spite of a EU decision to authorize exports again by August of that year. There are other cases that have raised disputes between the EU and the United States. In these cases, the PP has been used as a means to justify sovereign unilateral measures, based on unilateral judgements. Then, the involved parties initiated legal procedures, meaning that all parties did not share the same views on appropriate conditions of risk management. In some cases, such as the Cartagena Protocol on Biosafety, both uses of the PP are entangled. The core of this protocol is to define agreed procedures and conditions in which unilateral measures can derogate from ordinary rules of trade. It sets the right of an importing country to refuse an import of GMO on the basis of alleged potential risks not yet confirmed by scientific investigations, the assessment of those risks being allowed to include social and economic consequences of possible ecological effects. Yet we may wonder whether this construct is to be understood as the best means to preserve biodiversity on Earth, which is one of the main ultimate goals of the Convention to which the Protocol is affiliated, or just the conceded acknowledgement of a political space of expression for sovereign national preferences within the system of international trade rules. In order to answer yes to the first question, it would be necessary to demonstrate that a system based on the autonomous judgement of each national state regarding what can be accepted on its sovereign territory is actually the best strategy of biodiversity conservation at hand. If the demonstration were not provided, the adopted solution would rather mean a restoration of national sovereignty on politically sensitive issues, implying very different appreciations across regions. How shall we understand this double usage of the PP?


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A basic tension between legitimacy and effectiveness of preventive action I suggest that the explanation of the paradox is to be found in a basic tension affecting the PP in the field of the environment, between the primordial value given to state sovereignty for safety issues and conditions for the efficient management of global public goods. This is not a matter of contingent circumstances. In fact, for regional or global environmental public goods, the PP is torn between the need for a broad international cooperation, adapted to the very nature of issues, and the deep attachment to assigning responsibility for ensuring safety of persons and the community to politically legitimate sovereign bodies, that is, to national state governments. Each particular regime leads to some compromise between both directions. Dynamically, this interpretation points to alternations between forward moves towards enhancing cooperation and backward ones towards re-establishing national sovereignty. In that play, actual equilibriums between the two forces may be rather far away from what would be required from the strict viewpoint of management of the relevant regional or global issues. In particular, countries change their positions according to the issues, wanting more cooperation on one issue and more sovereignty on another one (Wiener and Rogers 2002). Conflicts arise because governments do not share the same ideas on which use should be selected for a given topic. In this regard, what happened in France through its constitutional reform is not wholly specific to this country. Other states have been particularly attentive to controlling the impact of the development of the PP on their sovereignty. It will be a long while before the PP benefits from the status of customary international law.

CONCLUSION This chapter has elucidated the relationship between the conceptual controversies regarding the PP, the way public debates have and can legitimately be developed about its legal status and the issue of sovereignty. It has been shown that a major aspect of the constitutional reform that incorporated the PP into the French Constitution was to confirm the proportionate PP concept and protect this French concept against possible future deviations coming from the EU or the international arena. It also aimed at reducing the supposedly excessive margin allowed to case law to define the benchmarks of management of potential risks affected by scientific uncertainty. As a matter of fact, persistent conceptual confusion about the PP explains both the reluctance of some parties to give it the highest value in

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the hierarchy of legal norms and the desire of the French public authorities to delimit an agreed domestic interpretation of a norm that initially came from regional and international soft law. As a result of this study, the basic approach to the PP, founded on the ideas of earliness and proportionality, which is at the roots of the present EU doctrine as well as the French one, has been demonstrated to pass the test of reflexive reason, whereas the Principle of Abstention and catastrophism, which the PP tended to be confused with, do not succeed with that test, being caught as general norms between double bind and pointlessness. Still pending is the tension between requirements of legitimacy – due to strong links between the PP and national sovereignty – and those of an effective international action for global environmental public goods, which ask for more integration. Paradoxically, it is in relation to these global environmental issues that the PP meets the greatest difficulties in being translated into concrete measures. In the future, consolidating the proportionate PP by giving it precise implementation procedures is all the more necessary as misinterpretations and distrust of EU governance could incite various states to define regimes of their own through constitutional reforms, which may give birth to additional sources of divergence within the EU and slow down the worldwide dissemination of a useful common understanding of risk management.

NOTES 1. 2.

3.

4.

Centre National de la Recherche Scientifique and Ecole polytechnique, Chair in Sustainable Development, Paris. E-mail: [email protected] A French environmental law adopted in 1995 (Law 95–101) defines the PP in the following terms: ‘the lack of certainty, under the present state of scientific and technological knowledge, should not lead to postponing effective and proportionate measures aimed at preventing threats of serious and irreversible damage to the environment at an acceptable economic cost’ – personal translation. This law also says that the PP should inspire actions of environmental protection under the conditions defined by law; it was then intended that additional law texts would be required to enforce the PP and other principles. Since the Wingspread Conference (January 1998) and the book edited by Raffensperger and Tickner (1999), the PP has been publicized in the United States as imposing a reversed burden of proof. Other scholars such as O’Riordan and Jordan (1995) had defended the same view in the UK. This requirement is the main reason why American authorities refuse to acknowledge that the PP has a domestic legal value. The paradox is that the EU Commission did not validate the idea of reversed burden of proof as a general principle and a key component of the PP. In fact, the PP does not imply a reversed burden of proof but aims to distance risk management from the concept of proof, whether we are considering proof of damage or proof of safety. The PP is about what you should do when you have no proof of either sort. See for instance the judgment of the Court of First Instance of the European Communities in the Pfizer case (2002).

Lessons from a constitutional reform in France 5. 6. 7.

8. 9.

10.

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Confédération française démocratique du travail. According to the maximin principle, each act is appraised by looking at the worst state for that act, and the best choice is the one with the best worst state. On this issue, the President of the French Constitutional Court, Pierre Mazeaud (2005) delivered clear comments at a solemn meeting with the President of the Republic: ‘Yes, due to the constitutional and popular consent, EU law is entitled to have direct legal force and, in case of conflict, primacy on national rules, including most of our constitutional rules. But no, however extended its primacy and directness could be, EU law cannot put into question what is explicitly written in our constitutional texts and is our own. Here I speak of all that is inherent to our constitutional identity, with the double meaning of the word “inherent”: crucial and distinctive. Said with other words: the essence of our Republic’. The PP is just quoted without definition among other principles in Article III-233 of the Treaty establishing a Constitution for Europe. Interestingly, at the EU level, human health is considered a relevant and legitimate field of implementation of the PP. Here lies a potential source of tension between French and EU law. Incidentally, the French law 2004–806, which was adopted in August 2004 to reframe the public health policy, states nine principles: they do not include the PP, but a ‘principle of earliness’. This Protocol entered into force in February 2005, without the participation of Australia and the United States.

REFERENCES Académie nationale de médecine (2003), Le souci de l’environnement et le développement durable, une indispensable complémentarité, Paris, 11 March. Académie des sciences (2003), Charte de l’environnement – Conclusion et recommandations, Paris, 18 March. Académie des sciences morales et politiques (2004), Avis sur le projet de loi constitutionnelle concernant la Charte de l’Environnement, Paris, 10 May. Bizet, Jean (2004), Avis présenté au nom de la Commission des affaires économiques et du plan sur le projet de loi constitutionnelle, adopté par l’assemblée nationale, relatif à la Charte de l’environnement, Paris: Sénat, Session ordinaire de 2003–2004, (353), annexe au procès-verbal de la séance du 16 juin 2004. Boy, Laurence, Christophe Charlier, Michel Rainelli and Patrice Reis (2003), ‘La mise en œuvre du principe de précaution dans l’accord SPS de l’OMC – Les enseignements des différends commerciaux’, Revue économique, 54(6), 1291–306. CFDT (2003), Déclaration de Jean-François Trogrlic, secrétaire national: La Charte de l’environnement intégrée dans la Constitution – Les politiques doivent passer du principe de précaution à sa mise en œuvre, Paris, 27 June. Commission of the European Communities (2000), Communication on the Precautionary Principle, Brussels, 2 February, COM(2000)1. Commission of the European Communities (2002), ‘Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety’, Official Journal of the European Communities, L 31, 1 February, pp. 1–24. Conseil constitutionnel (2004a), Décision no. 2004-505 DC du 19 novembre 2004 (Traité établissant une Constitution pour l’Europe), Paris.

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Conseil constitutionnel (2004b), ‘Décisions et documents du Conseil constitutionnel: Décision no. 2004-505 DC du 19 novembre 2004 – Traité établissant une Constitution pour l’Europe’, Cahiers du Conseil constitutionnel, 18, Paris. Coppens, Yves (président) (2003), Rapport de la Commission de préparation de la Charte de l’environnement, Paris: Ministère de l’écologie et du développement durable, April, http://www.ecologie.gouv.fr/IMG/pdf/rapport_coppens.pdf (accessed 21 October 2005). Court of First Instance of the European Communities (2002), Judgment of the Court (Third Chamber), Pfizer Animal Health SA v. Council of the European Union, Case T-13/99, 11 September. European Council (2000), Resolution on the Precautionary Principle, Annex III of Conclusions of Presidency, European Council of Nice, 7–9 December. European Environment Agency (2001), Late Lessons from Early Warnings. The Precautionary Principle: 1896–2000, Environmental issue Report 22, Copenhagen: EEA. Ewald, François (2004), ‘2004, une France précautionneuse?’, Les Échos, 8 January. Ewald, François, Christian Gollier and Nicolas de Sadeleer (2001), Le principe de précaution, Paris: PUF, (Coll. ‘Que sais-je ?’). Gélard, Patrice (2004), Rapport fait au nom de la Commission des Lois constitutionnelles, de Législation, du Suffrage universel, du Règlement et d’Administration générale sur le projet de loi constitutionnelle, adopté par l’Assemblée nationale, relatif à la Charte de l’environnement, Paris: Sénat, Session ordinaire de 2003–2004, (352), Annexe au procès-verbal de la séance du 16 juin 2004. Godard, Olivier (ed.) (1997), Le principe de précaution dans la conduite des affaires humaines, Paris: Éd de la Maison des Sciences de l’Homme et INRAEditions. Godard, Olivier (2003), ‘Le principe de précaution comme norme de l’action publique, ou la proportionnalité en question’, Revue économique, 54(6), 1245–76. Godard, Olivier (2005), ‘Le principe de précaution et la proportionnalité face à l’incertitude scientifique’, in Conseil d’Etat, Rapport public 2005 – Responsabilité et socialisation du risque, Paris: La Documentation française, pp. 377–92. Godard, Olivier, Claude Henry, Patrick Lagadec and Erwann Michel-Kerjan (2002), Traité des nouveaux risques: Précaution, crise, assurance, Paris: Gallimard, (Coll. ‘Folio-Actuel’ no 100). Gonzales Vaqué, Luis, Lothar Ehring and Cyril Jacquet (1999), ‘Le principe de précaution dans la législation communautaire et nationale relative à la protection de la santé’, Revue du Marché Unique Européen, 1, 79–128. Greenpeace France (2005), Principes fondateurs, http://www.greenpeace.org/france/ about/principes-fondateurs (accessed 21 October 2005). Jonas, Hans (1984), The Imperative of Responsibility: In Search of an Ethics for the Technological Age, Chicago: University of Chicago Press. Kosciusko-Morizet, Nathalie (2004), Rapport fait au nom de la Commission des lois constitutionnelles, de la législation et de l’administration générale de la République sur le projet de loi constitutionnelle (no 992) relatif à la Charte de l’environnement, Paris: Assemblée nationale, no 1595,19 May. Kourilsky, Philippe and Geneviève Viney (2000), Le principe de précaution. Rapport au Premier ministre, Paris: Éd. Odile Jacob. Lepage, Henri (2003), Le principe de précaution: la fin du règne du droit, Paris: Les


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Cercles Libéraux, 30 April, http://www.cerclesliberaux.com/newsite/newcercles/ article.php 3?id_article=129 (accessed 21 October 2005). Martinand, Claude (rapporteur) (2003), ‘Environnement et développement durable, l’indispensable mobilisation des acteurs économiques et sociaux – Avis adopté par le Conseil économique et social au cours de sa séance du mercredi 12 mars 2003’, Journal officiel de la République française (41103-0008), 18 March. Mazeaud, Pierre (2005), Vœux du Président du Conseil constitutionnel, M. Pierre Mazeaud, au Président de la République, Paris, 3 January. Noiville, Christine (2000), ‘Principe de précaution et Organisation mondiale du commerce: Le cas du commerce alimentaire’, Journal du Droit International, 127(2), 263–97. O’Riordan, Tim and Andrew Jordan (1995), ‘The precautionary principle in contemporary environmental politics’, Environmental Values, 4, 191–212. Perben, Dominique (garde des Sceaux et ministre de la justice) (2004), ‘Audition sur le projet de loi constitutionnelle relatif à la Charte de l’environnement (no 992)’, Compte rendu no 45, Paris: Assemblée nationale, 2 March. Popper, Karl Raimund (1953), Conjectures and Refutations: The Growth of Scientific Knowledge, Oxford: Routledge Classics (last edition 2002). Raffensperger, Carolyn and Joel Tickner (eds) (1999), Protecting Public Health and the Environment: Implementing the Precautionary Principle, Washington, DC: Island Press. Seillière, Ernest-Antoine (2004), Point de presse, Paris: MEDEF, 13 January. Sénat (2004), Projet de loi constitutionnelle relative à la Charte de l’environnement adopté le 24 juin 2004, Texte no 102, Session ordinaire 2003–2004, Paris, http://www.senat.fr/leg/tas 03-102.html (accessed 21 October 2005). Wiener, Jonathan B. and Michael D. Rogers (2002), ‘Comparing precaution in the United States and Europe’, Journal of Risk Research, 5(4), 317–49.

5. Precautionary policy assessment for sustainability Stephen Dovers INTRODUCTION The precautionary principle (PP) is one of several principles expressed in policy and legal statements of sustainability (or sustainable development internationally, or ecologically sustainable development (ESD) in Australia). It is the most tractable in the sense of policy and legal interpretation and has received the most focused attention. However, sustainability is an integrated agenda, and the PP should not be taken in isolation from other principles. In this chapter, the PP is not the sole focus but is considered in terms of its interpretation and implementation in policy-making contexts alongside other principles and imperatives. The sustainability agenda is significantly different, and more difficult, than the more traditional environmental policy agenda, and the past decade has been characterized by halting steps to address sustainability, but also by a growing acceptance that environmental issues can only be properly resolved through proactive, long-term strategies that address social and economic dimensions as well as environmental. The standard Australian version of sustainability principles, enunciated in its 1992 National Strategy for ESD, are representative, with the exception of the peculiar weighting in Guiding Principles 4 and 6 toward neoliberal economic policy approaches (Australia 1992), and the expression of the PP (in italics) as Principle 2 is typical enough: Goal: Development that improves the total quality of life, both now and in the future, in a way that maintains the ecological processes on which life depends. Core objectives: 1. To enhance individual and community well-being and welfare by following a path of economic development that safeguards the welfare of future generations. 2. To provide for equity within and between generations. 3. To protect biological diversity and maintain essential ecological processes and life-support systems. 88

Precautionary policy assessment for sustainability

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Guiding principles: 1. Decision making processes should effectively integrate both long and shortterm economic, environmental, social and equity dimensions. 2. Where there are threats of serious or irreversible environmental damage, lack of full scientific certainty should not be used as a reason for postponing measures to prevent environmental degradation. 3. The global dimension of environmental impacts of actions and policies should be recognised and considered. 4. The need to develop a strong, growing and diversified economy which can enhance the capacity for environmental protection should be recognised. 5. The need to maintain and enhance international competitiveness in an environmentally sound manner should be recognised. 6. Cost effective and flexible policy instruments should be adopted, such as improved valuation, pricing and incentive mechanisms. 7. Decisions and actions should provide for broad community involvement on issues which affect them.

Discussion of the PP has been mostly about discrete environmental issues – how to apply the principle to proposals for such things as a power plant or road development. These involve first order or direct environmental impacts that may be serious or irreversible and are characterized by uncertainty. Applying the principle in such contexts has been difficult and no clear rules of application have yet appeared. In such applications, the PP can be understood as a codification of changing social values: we used not to care much about the environment, whereas now we do and this should be reflected in a higher level of caution. Such applications of the PP are important and must be persisted with in environmental impact assessment (EIA) (Gullett 2000). However, it has become increasingly apparent that, to address environmental degradation and the social vulnerability and economic failures that interact with such degradation to comprise the sustainability agenda, direct causes are less crucial than indirect causes. The causes of ecologically unsustainable and humanly undesirable development are systemic, located deep in patterns of production and consumption, settlement and governance. The release of a chemical into a stream, clearing remnant native vegetation or the emitting of carbon dioxide are all direct, obvious manifestations of economic, institutional and cultural settings that evolved without regard to sustainability and which are resistant to change. If the institutional drivers and incentive structures underlying individual and collective behaviours have evolved with little regard to the environment, or to human well-being, then it is predictable that these behaviours will cause problems. Deeper change is required to pursue sustainability, not only targeting discrete developments or behaviours, but underlying policy processes, institutional systems and legal frameworks – a shift from projects toward higher levels in the policy system.

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This chapter explores the role of the PP in addressing indirect causes of unsustainable human development via cross-sectoral policy assessment, that is, assessment of the environmental and sustainability implications of proposals and decisions made in non-environmental portfolios, addressing approaches to policy assessment; supporting methods; assessment targets and thresholds; predictability and burdens of proof; and institutional settings. The concluding section offers a hierarchical conceptualization of the PP and other approaches, including policy assessment.1 Before this, however, the chapter discusses the nature of sustainability problems, and clarifies the meaning of the PP.

THE NATURE OF SUSTAINABILITY PROBLEMS It is a commonplace that significant sustainability problems – climate change, biodiversity, population-environment linkages, integrated land and water management or maintenance of ecosystem services – are difficult policy and research problems. It pays to delve deeper and to identify the attributes of these policy problems that make them different and/or difficult and thus why they invite particular policy responses (Dovers 1995, 1997): ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

broadened, deepened and highly variable spatial and temporal scales; the possibility of absolute ecological limits to human activity; complexity within and connections between problems; pervasive risk and uncertainty, often not amenable to probabilistic analysis; irreversible effects; cumulative rather than discrete impacts; new moral dimensions (for example, other species, future generations); ‘systemic’ causes, embedded in patterns of production, consumption, settlement and governance; important environmental assets not traded in formal markets, and thus not ascribed a monetary value; difficulty in separating public from private costs and benefits; lack of uncontested or widely practised policy instruments and management approaches; lack of defined policy, management and property rights, roles and responsibilities; need for integrated/interdisciplinary knowledge; intense demands for community participation in both policy formulation and actual management; and sheer novelty as a suite of policy problems.


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These attributes are not as commonly encountered in other policy fields, especially in combination, suggesting that different research and policy responses are required. Traditional policy approaches and knowledge systems may have poor purchase on sustainability problems, and so assessing the sustainability implications of public policy settings and proposals will test existing intellectual and policy capacities. Any of these attributes may be important in a given situation but, for this discussion, systemic causes and pervasive uncertainty are the most crucial, and in turn strongly determine other attributes. In combination with three core sustainability principles – the requirement for long-term policy approaches, integration of environmental, social and economic policy (policy integration principle), and the PP – these problem attributes define the requirement for policy assessment that can handle uncertainty.

THE NATURE OF THE PRECAUTIONARY PRINCIPLE Before proceeding to the application of the PP in policy assessment, clarification of its meaning in the context of this chapter is required. If strategic policy assessment is to occur, in what ways can the precautionary principle inform the process or serve to focus attention on key issues? Most literature on the principle recognizes a set of implications (for example, Dovers and Handmer 1995; 1999), and each of these has relevance to policy assessment. The following describes these implications in terms more relevant to policy rather than project assessment: ●

●

Explicit recognition of uncertainty. While it is established that institutional and policy settings influence sustainability, significant uncertainty exists about specific consequences. Thus it is important to recognize uncertainty in addressing broad policy initiatives, just as it is in assessing the impacts of a specific development project. Recognition of qualitative and variable forms of uncertainty. Following Smithson (1989), precautionary decision making must deal not only with quantitative risk in a probabilistic sense, but also qualitative uncertainty of various kinds, including deemed irrelevance, distortion, taboo and uneven information distribution in the community, where believable probability distributions cannot be assigned to the range of outcomes. This is even more the case when indirect or systemic threats and causes are confronted, and demands interdisciplinary approaches to assessing threats of environmental or human degradation. Uncertainty is likely to change in kind

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●

●

●

●

and increase in degree when cross-sectoral policy impacts are considered.2 Recognition of ‘serious or irreversible’ impacts. This is a key trigger in applying the PP but little attention has been given to this trigger in the case of indirect impacts. Serious or irreversible indirect impacts would include such changes as reductions in environmental management capacity not repairable in the short term, loss of continuity in core environmental data sets, or significant changes in property rights. Refocusing policy attention from reactive to proactive or preventative measures. This suggests more attention to the underlying causes of environmental effects, and an expansion of attention to broad policy and institutional processes. This is the objective of higher order assessment approaches such as strategic environmental assessment (SEA). Shifting the onus of proof from opponents to proponents of development. If broader policy, legal and institutional proposals become targets for precautionary assessment, then proponents rather than opponents of changes should share the onus of establishing that the proposal will not damage prospects for sustainability. Exploration of alternatives. The PP implies moving beyond mere amelioration of impacts of a pre-determined project proposal, to considering alternatives. It is appropriate to consider the ends and means of a policy proposal, to assess whether the end (say, economic or administrative efficiency) can be achieved in the manner most consistent with sustainability.

Implementing the PP to inform decisions is not only or even primarily a technical matter, but a political one (Hanson 2003), and even more so when applied to higher order policy. This position, however, even given its inevitable logic when the assessment of complex policy impacts is considered, is at odds with the emphasis in expressions and discussions of the PP on ‘scientific (un)certainty’. If scientific uncertainty – quantifiable and amenable to eventual resolution by data gathering – is the only admissible form, then the PP is of marginal use in situations characterized by contested values, perceptions or interests, or radical uncertainty – that is, any significant environmental issue. This chapter adopts such a wider construction of uncertainty. In applying the PP to policy assessment, in line with the points above, several issues require further exploration: the status of policy assessment approaches and processes; availability of supporting frameworks and techniques; targets and thresholds for assessment; predictability of indirect threats and causes; institutional settings; and burdens of proof that would


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be applied in triggering assessment and in decision making informed by an assessment. These issues are dealt with in the following sections, before the concluding section presents a hierarchical conceptualization of the PP and other approaches to policy and decision making in the face of uncertainty.

POLICY ASSESSMENT: APPROACHES, TARGETS AND THRESHOLDS One option for examining the sustainability implications of policy initiatives is to conduct policy assessment. Just as standard EIAs analyse the possible impacts of a proposed project, policy assessment looks at the likely effects of broader policy initiatives, plans and programmes. The aim is to subject such policies to the same thorough scrutiny that project proposals ideally receive under EIAs. Project-based environmental impact assessment (EIA) is core to environmental policy, but does not attend to cumulative effects of multiple projects or to the policy settings that influence individual proposals or developments. While EIA can assess the impacts of a mine or a coastal development, it does not scrutinize the industry policy, taxation incentives, regional development plans or other policy settings that determine the quantity and nature of such projects. Methodologies proposed to address this deficiency include: strategic environmental assessment (SEA) of policies, plans and programmes; sustainability assessment (SA) that explicitly deals with social and economic as well as environmental concerns; integrated assessment (IA) of the environmental, social and economic impacts of development projects; and technology assessment (TA) targeting new or proposed scientific and technological developments (Porter and Fittipaldi 1998; Partidario and Clark 2000; Bond et al. 2001; Marsden and Dovers 2002; Jakeman and Letcher 2003; Gibson et al. 2005). Other possible mechanisms include legislative reviews, review of environmental concerns in Cabinet submissions, or the (minimal) reporting on sustainability issues in annual reports of agencies such as is required under the Australian Environment Protection and Biodiversity Conservation Act 1999. Of these, SEA is the most widely catered for by statutory and policy provision and in actual application. While under-implemented in most jurisdictions, the recent European Union SEA directive and the adding of an SEA protocol to the Espoo Convention on trans-boundary EIA, among other developments, make it the most likely candidate for widespread application. Table 5.1 presents principles for SEA which describe an ideal regime. A crucial tension in proposals for policy assessment can be noted. While SEA has been in principle superseded by the more integrated notion of SA,

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Table 5.1


Principles of SEA

1. Initiating agencies are accountable for assessing the environmental effects of new policies, plans and programmes; 2. The assessment process should be applied early in proposal design; 3. The scope of assessment must be commensurate with the proposal’s potential environmental impact; 4. The objectives and terms of reference should be clearly defined; 5. Alternatives to, as well as the environmental effects of, a proposal should be considered; 6. Other factors, including socio-economic considerations, should be considered as appropriate; 7. Evaluation of significance and determination of acceptability should be made against a policy framework of environmental objectives and standards; 8. Provision should be made for public involvement, consistent with the potential degree of concern and controversy of the proposal; 9. Public reporting of the assessment and decisions (some confidentiality may be required but the basis for this should be explicit); 10. Independent oversight of the implementation process, compliance and government-wide performance; 11. SEA should result in the incorporation of environmental factors in policy making; 12. The SEA should be linked to other SEAs, project EIAs and monitoring for proposals that initiate further actions. Source: Contracted from Sadler and Verheem (1996); Marsden (2002).

some argue that the former is more appropriate as it explicitly gives weight to the environment in decision making, which it has previously not had. Whereas SA, in seeking to integrate environmental, social and economic factors, may simply see the environment diluted and discounted. While SEA and related approaches have potential for assessing the sustainability impacts of policy in a precautionary fashion, they are not currently designed to do so nor are they implemented widely. They do not explicitly or even always implicitly incorporate the precautionary principle, and for the most part target classes of direct threats and causes rather than indirect or systemic ones, and are not designed to be applied primarily to government policy proposals (a politically sensitive issue). However, it is possible to adapt these for such purposes (Dovers 2002a). In any adaptation, clear inclusion of the PP would be required, and the nature of sustainability problems would demand recognition of environmental, social and economic factors, and the incorporation of both expert and community perspectives.3 Hence policy assessment requires formalized and transparent structures and processes aimed at coordinating policy, science


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and community. Moreover, ‘science’ in this context will include a range of natural and social science disciplines, indigenous ecological knowledge, and the emerging domain of ‘citizen science’ (Lee 1993). The targets of an SEA regime thus enhanced, or another form of precautionary policy assessment, can be defined as any policies, laws or proposals that could significantly alter patterns of production and consumption, settlement and governance. For example, policies that encourage particular forms of consumption through changes in taxation, industry policy settings or education campaigns may have systemic environmental implications, as would those that affect capacities to monitor, manage or protect the environment. In proposing a stronger role for SEA, Goodland (1998) and Buckley (1998) proposed the following targets: ● ● ● ● ● ● ● ● ●

international agreements on trade, finance or defence; development assistance programmes; privatization/corporatization of public agencies/functions; interstate agreements in a federal system; foreign ownership approval processes; government budgets; sectoral policies, plans and programmes (for example, energy, water, transport); structural adjustment programmes; and tax systems.

These targets for SEA could be assessed for broader sustainability impacts. However, it would be impossible to mount a full assessment of every possible proposal and some threshold test would be required. The following thresholds and criteria are general, but indicate the sorts of tests that would be applied to trigger an assessment (more detailed criteria would be developed in designing a regime: ●

● ● ● ●

of significant cross-sectoral impact, affecting policy and management across a range of policy sectors, portfolios and substantive issues; of a whole-of-government nature, affecting most or all portfolio areas and agencies; likely to result in significantly altered public expenditure; determining patterns of research and development investment; involving significant restructuring or changed capacity of relevant public agencies with responsibilities for resources or environment, or with significant relevance to resources and environment (for example, mining, transport, planning, statistical agencies);

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General implications of the precautionary principle ● ●

●

involving significant changes to tenure, property rights or resource rights and allocation regimes; likely to affect substantially the rights of stakeholders to participate in environmental decisions, or the ability of the public to gain access to information about the state of the environment or about environmental law, policy and management; and/or a financial trigger, such as investment or programme cost over a defined amount.

It is apparent that the focus of precautionary assessment is the state or public sector. Private sector proposals are subject to project scale EIA, and many firms now use environmental accounting, environmental management systems, codes of practice and the like. It is governments that are responsible for the deeper policy, legal and institutional changes (or lack thereof) that influence indirect threats to sustainability, and moreover which are often reluctant to subject their own decision making to scrutiny. Addressing these targets and criteria will require the incorporation of social and natural science disciplines and public participation in the policy process in predictable and transparent ways, which will require, first, operational frameworks and techniques for implementation and, second, appropriate institutional settings. Implementation Frameworks and Techniques Policy assessment requires supporting techniques and methods. Existing or proposed policy assessment methods such as SEA can be adapted to provide a procedure, with existing sustainable development policy providing overarching objectives and guiding principles. Additional support will be needed, utilizing a range of techniques and approaches suited to informing policy decisions under conditions of uncertainty (see discussion later in this chapter, and specifically Table 5.2). A general decision-making framework for dealing with uncertainty is required, such as the Australian/New Zealand Standard 4360 Risk Management adapted for environmental management (Standards Australia 2000). This provides a framework for managing risk, including the subsidiary component of risk assessment, and directs users to specific techniques. However no single or superior method will emerge, and policy assessment must draw on a diverse toolkit, with reference to the particular context, issues, and kind of information available. An important element of assessment methodology under conditions of uncertainty and novelty is the accumulation of information and lessons across contexts and over time. This requires two strategies. One is the insti-


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tutionalization of policy learning so that previous experience informs later assessments. This will take time. While policy learning is an obvious need it is often absent (see May 1992; Lee 1993; Connor and Dovers 2004). The second strategy is more immediate: the identification and consolidation of existing information and experiences through structured, purposeful review. While imperfect, our understanding of indirect threats and causes has increased and can inform the setting of targets and thresholds for assessment. For example, recent reviews of the impact of micro-economic reform (marketization) on environmental management capacities offer a much deeper understanding than was available even a decade ago (for example, Bosselman and Richardson 1999; Productivity Commission 2000; Connor and Dovers 2004). So, while not a rigorously predictive science, possible impacts of, for example, economic policies could be assessed qualitatively. An increased emphasis on purposeful accumulation and application of policy experiences is an obvious response to uncertainty, and is consistent with the extension of the idea of adaptive management (AM) to policy processes and institutional arrangements (Gunderson et al. 1995; Dovers and Mobbs 1997). In the face of uncertainty, AM instructs posing management and policy interventions as experiments to be monitored and utilized to increase understanding, an approach that complements the precautionary principle. Institutions for Policy Assessment Comprehensive policy assessment will require suitable institutional settings. Establishing institutional settings for policy assessment as proposed here embed a precautionary approach across the policy system and clarify the engagement of different knowledge systems in the policy process. Various institutional models for policy assessment exist. Responsibility could be located within an existing agency, such as an environment department, in a separate organization, in the private sector under contract, or in a combination of these. Assigning private sector consultants responsibility for policy assessment has inherent dangers: of continuity of method, accumulation of knowledge, and of the wariness of producing assessments that endanger future contracts. Making assessment the task of a line department under direct control of a Minister or Secretary may be unwise given the political nature of the task and the fact that environment agencies are generally relatively junior within the hierarchy of portfolios. This suggests a specific agency, possibly with use of external consultants, as the logical model – a statutory authority or a statutory office of parliament. The need for specialist skills argues against giving responsibility to a generic review agency

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such as an auditor-general, at least in the absence of an amended mandate and added human resources. We can define the characteristics such an agency would need to display, drawing on institutional theory and the idea of adaptive institutions for sustainability (Gunderson et al. 1995; Goodin 1996; Dovers and Mobbs 1997; Dovers 2001a,b; Dovers and Wild River 2003). One characteristic is independence from the day-to-day pressures of executive government, if the favoured policies of the day are to be objectively scrutinized. Another is a clear mandate and defined functions provided through statutory provision. Adequate resources are necessary, including human, financial and informational resources. As there is no single, accepted approach a mandate is required for flexibility and experimentation with methods along with access to interdisciplinary expertise. Finally, an assessment regime would need to be inclusive of stakeholders and transparent in its operations (possibly including provision for targets of assessment to be nominated by the community and private sectors). This suggests no small task of institutional design. We can look to institutional models that undertake other functions such as policy development or advice, state of environment reporting, cross-portfolio review of achievement of sustainability policy, or sectoral or regional inquiry. One option is commissioners for the environment (for example, in New Zealand), or a central office of sustainability in a first minister’s department (for example, in a number of Australian jurisdictions). Another is a statutorily independent environmental protection authority (for example, in the USA). A quite different alternative option is an inclusive, independent national council or commission, now established in over seventy countries as some form of national council for sustainable development (NCSD). However, these are advisory only and unsuited to the purpose considered here without reform (Connor and Dovers 2004). A final option is a specific statutory authority sharing some of the attributes of Australia’s now-defunct Resource Assessment Commission (RAC) (Hamilton 2003), Victoria’s now-emasculated Land Conservation Council (Dovers 2001b), and the world’s most striking assessment model, the nowdefunct US Office of Technology Assessment. While there is considerable irony in the fact that these three partial, encouraging models are either now disbanded or diminished, the positive is that they convey the possibility of such a suitable statutory body within existing institutional and political parameters. These options are illustrative, and while none are perfect models and all would require institutional and legal change to undertake cross-sectoral policy assessments for sustainability, their existence indicates that it would be possible to create a suitable institutional arrangement. The design of


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a specific arrangement would need to be undertaken carefully, reflecting the realities of the jurisdiction, specific roles envisaged and targets for assessment.

PREDICTION AND BURDENS OF PROOF Handling uncertainty and novel situations raises the issue of the predictability of indirect or systemic causes of unsustainability. Environmental degradation is largely caused by policy decisions in non-environmental portfolios. Past failures to consider such threats have led to unsustainable practices, and this instructs that we consider indirect impacts in the future. But can we predict the impact of policies with sufficient clarity, or can we only be wise with hindsight? Indirect impacts will rarely be predictable in a quantitative sense, but may be so in a qualitative manner. This invites questions as to the role of different knowledge systems, scientific disciplines and modes of inquiry. It is likely that, in policy assessment as opposed to project assessment, the greater importance of qualitative information and judgements will require different approaches, such as deliberative more often than technical methods or multi-criteria analysis more often than traditional cost-benefit analysis. Discussions of risk, the PP and decision making in the face of uncertainty often agree that we cannot rely solely on the resolving power of reductionist, quantitative science, and this is especially important for assessment of broad policy approaches. The most detailed assessment will produce uncertain findings. The nature of the questions asked will require a range of inputs – natural science, social science, community opinion and traditional or indigenous knowledge. It will be necessary to apply what Funtowicz and Ravetz (1991) refer to as ‘post-normal science’, to be utilized under conditions of high uncertainty but potentially significant impacts, requiring engagement of ‘extended peer communities’ to frame questions and interpret findings. Moreover, values and political judgement will – unavoidably and rightly – play a major role in final decisions, along with scientific assessments. For example, in an exhaustive investigation into mining adjacent to Kakadu National Park, Australia’s Resource Assessment Commission reported to the Australian government on economic, ecological and sociocultural impacts. To the disappointment of those who wanted a yes/no recommendation, the RAC made it clear that, in the absence of a plausible common denominator, balancing of these must be a political decision. Then the Prime Minister drove a decision disallowing the mine largely on the basis of indigenous cultural issues; the mining lobby and other

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political figures were outraged and the RAC was disestablished shortly thereafter (Hamilton 2003). It is important to recognize this reality and not harbour false expectations of ‘rational’, clear outcomes, when the combination of different forms of knowledge, information and values must always involve political (that is, value-based) decisions. Allocation of burdens of proof is a core issue.4 There are two aspects to this: the burden of proof required to trigger an assessment; and that required to justify policy change or ameliorative measures if an assessment identifies significant issues. Scientific burdens of proof (95 or 98 per cent confidence) are different from legal burdens of proof (balance of probabilities, beyond reasonable doubt). Precaution suggests that legal traditions of proof, avoiding Type II errors (false negative), would be more suitable than, or at least should be as equally favoured as, scientific traditions of proof, which are more wary of Type I errors (false positive) (Cranor 1999). In qualitative assessments subject to multiple inputs of information and judgement, there are other burdens of proof, including those often highly risk-averse ones evident in the perception of risk in local and lay communities, which in a democratic system must be given weight even when ‘expert’ opinion does not confirm these perceptions. Moreover, using defendable data and methods, different experts will arrive at varying conclusions as to risks. With sustainability problems, and especially with systemic causes, it is not only the quantitative natural sciences that will have bearing on policy assessments, but also the qualitative judgements of political science and public administration, predictions arising from neoclassical economic models, and burdens of proof operating in political and media debates. Cranor (1999) defines a series of burdens of proof which could be operationalized as a set of options, with the burden in a specific case chosen following informed, qualitative judgements and flowing from an open, discursive process. Such a graduation of strictness of burdens of proof amounts to degrees of application of the PP, with the strength of application varied according to the significance of impacts and the costs of policy change. What might result from a precautionary policy assessment and what response is appropriate when indirect threats to sustainability are identified? Some likely options include: more attention to the initial design of statutory frameworks; placement and resourcing of residual environmental functions following organizational change; enablement of provisions for public participation; or increased or refocused monitoring of environmental change or policy implementation. Alternatively, it may be that a policy proposal could be withdrawn or radically altered in the light of assessment of its sustainability implications, although this may be rare. The cost and significance of the proposed ameliorative strategies would be a factor in


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determining the appropriate burden of proof: low cost measures would invite a lower burden of proof and vice versa. Most often, the outcomes of an assessment would be simple, precautionary measures, not radical change.

PRECAUTIONARY POLICY ASSESSMENT: FANCIFUL OR FEASIBLE? Given that precautionary policy assessment is scarcely evident as a structured process anywhere in the world, is the proposition fanciful? To explore the prospects, this section very briefly considers three examples – cases of possible application drawn from the Australian national jurisdiction – all of which fit the description of suitable targets for policy assessment as defined above. The three examples are: National Competition Policy (NCP) versus ecologically sustainable development (ESD) policy; the US-Australia Free Trade Agreement (FTA); and recent water policy reform culminating in a National Water Initiative (NWI). These are described in more detail elsewhere (Hamilton and Throsby 1998; Cater 1998; Dovers and Gullett 1999; Productivity Commission 2000; Curran and Hollander 2002; Cebon 2003; Connor and Dovers 2004; Connell et al. 2005). The NCP/ESD example contrasts two higher order goals prominent on political agendas in the 1990s and since – economic efficiency (NCP) and environmental sustainability (ESD) – both driven through the Council of Australian Governments (COAG) comprising state and national heads of government. NCP was a ‘top-down’ process and has been implemented vigorously across policy sectors, with strong institutional mechanisms (Australian Competition and Consumer Commission and National Competition Council (NCC)), significant financial commitments, and a wide ranging review of legislation across all policy sectors to ensure removal of processes and policies deemed at odds with free market competition (see National Competition Council 2003; 2004). Although environment and sustainability was one part of a public interest test, this has had little impact on the implementation of NCP. In contrast, the National Strategy for ESD was an inclusive process with much trading off of environment against economic imperatives, has been scarcely institutionalized in the policy system nationally, and is generally regarded as having been weakly implemented (Productivity Commission 1999; Dovers 2002b). Two alternative scenarios can be pondered: that ESD could have been as strongly implemented as NCP; or that NCP could have been subjected to a rigorous environment/ sustainability assessment. The prospects of thousands of statutes being subject to review for consistency with sustainability as were assessed for

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consistency with NCP is logical, but politically naïve. This example invites a number of interpretations: that sustainability is simply not sufficiently supported politically to be implemented vigorously across policy sectors; that even if it was there are not the familiar methods or processes to do so; but that the NCP case shows precedent for cross-sectoral policy and legislative assessment to ensure consistency with higher order social and political goals. Trade agreements are often cited as a logical target for strategic environmental assessment (see above), and analysis of the US-Australia FTA that came into force in 2005 identified potential sustainability implications of sufficient significance to support this proposition. Yet, other than simplistic political debate in the media, government-sponsored reports, and a belated Senate inquiry, the Australian process did not include transparent, inclusive or precautionary assessment of potential environmental let alone sustainability impacts of the agreement. Apart from the fact that a supportive national government did not see the need for such an assessment, there is no institutional ‘home’ for such a process. The FTA and NCP cases are classic SEA or precautionary assessment targets – major economic policy initiatives that could be scrutinized for potential impact on sustainability. The outcomes of such assessment would probably not be radical change but rather precautionary measures such as, in the water sector, NCP-driven market and organizational change being balanced by ensuring that residual environmental protection functions were properly assigned following corporatization, that long-term monitoring unprofitable in the short term for reformed agencies was continued, or that public participation and cross-agency links for catchment management were otherwise maintained. Similarly, reform of the electricity sector might have counterbalanced an impact that would be predicted by economic theory – that price reductions for bulk consumers would equal increased energy use and thus greenhouse emissions – through countervailing policy measures. Recent reforms in the water sector leading to the creation of the NWI, on the other hand, were driven in part by environmental concerns, especially river health and salinity, as well as by a perceived need to achieve economic efficiency through application of property rights instruments (PRI) in the form of a water market. The new NWI requires, inter alia, major advances in information on hydrological systems and the setting of defensible sustainable limits on extraction, the definition of environmental flows, new risk sharing formulae across public and private sector interests, a national water rights trading system that will incorporate for the first time land uses such as forestry, a new system of water management plans for regions/catchments, and significantly increased commitments to transparency and public access


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to information. Again driven by COAG through a less than consistent and inclusive process, the long-term prospects for this policy initiative are contested. Significant uncertainties attach to the achievement of environmental goals via PRI, including: the scientific credibility and legal defensibility of the environmental limits on extraction in each catchment within which a market must operate; the likelihood of meeting information needs associated with the new policy regime and especially registers of rights and trades and physical water accounts; the adequacy of the newly-established National Water Commission and other institutional mechanisms to implement the Initiative; legal liabilities for compensation in the face of future policy shifts; resilience of the policy regime in the face of Australia’s variable climate; and socio-economic impacts on rural communities. It is clearly the case that the fundamental institutional and policy goal shifts implicit in a strong PRI regime have not been rigorously considered, and that available insights from both theoretical and empirical work in other resource sectors (especially fisheries) have not been utilized. A full and precautionary policy assessment would in all likelihood have exposed and enabled debate and analysis around such issues. But a further insight from this case is that even environmental or resource policies proposed on the basis of pro-sustainability outcomes should be considered as targets for thorough scrutiny via precautionary policy assessment.

PROSPECTS AND CLARIFICATION This chapter has argued that the PP has a logical arena of application in the assessment of higher-order policy proposals, as well as in the domain of specific development proposals and direct impacts. Without such assessment, indirect causes of environmental degradation and threats to sustainability will remain unattended, and policy responses will address symptoms rather than causes. The chapter has also shown that precedents exist for assessing other policy domains against a recent, higher order social goal, and that the institutional, methodological and other requirements of undertaking precautionary policy assessment are significant but not insurmountable. Positively, there are implementation opportunities for precautionary policy assessment. SEA is the most advanced possibility, and exists in a number of jurisdictions. The EU SEA directive recognizes the precautionary principle. The Environment Protection and Biodiversity Conservation Act 1999 at the national scale in Australia has SEA provisions that, although discretionary, offer a chance to implement and demonstrate the potential. The 70+ national councils for sustainable development offer a location within institutional systems for the promotion of policy

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assessment, as do, in many jurisdictions, emerging whole-of-government sustainability mechanisms. Negatively, despite the logic and implementation opportunities, precautionary assessment of the sustainability implications of the major policy proposals of central agencies would appear a distant prospect in the current political and institutional environment, and the construction of a transparent regime for consistent application of such assessment even more so. However, given the logic and viability of the proposal as a response to sustainability, and the fact that the transition toward sustainability is at least a generational task, the magnitude of effecting such deeper policy and institutional changes should not surprise (Connor and Dovers 2004). The core constraint at present is political will to pursue sustainability against other social goals (for example, economic efficiency, resource development). With no prospect of reversal of the recent trends of (i) worsening sustainability problems and (ii) increasing realization of inadequacy of policy responses, there is nonetheless the prospect that commitment to deeper reforms may emerge in future. Major policy and institutional change for the most part appear slow processes, but windows of policy opportunity do appear unexpectedly, and policy and institutional change are in fact typically characterized by fits and starts, where periods of slow or even non-existent reform are punctuated by periods of quicker change. Thus, the proactive development of well-constructed and widely-understood proposals for advancement at such times is important. Another constraint to precautionary policy assessment is a lack of such wider appreciation of the potential of existing or proposed policy assessment approaches. SEA for example is largely unknown outside a distinct professional and academic community. The PP is mostly discussed amongst lawyers, and its potential is not appreciated in, for example, the environmental risk community. There is another distinct community concerned with adaptive management. Although potentially bound together by the twin problems of uncertainty and complexity in human-natural system interactions these groups lack connection. Two antidotes can be suggested. The first is communication of the theoretical and technical details of the various, equally viable approaches to informing decisions under conditions of uncertainty, toward a shared appreciation of a toolkit of approaches to be used in different circumstances. The second is a common conceptual framework for understanding this diversity of approaches. For example, what is the relationship between the PP, risk assessment, adaptive management and strategic environmental assessment? Table 5.2 proposes a hierarchy beginning with the social goal of sustainability. The next three levels operationalize this goal with respect to handling uncertainty, through principles, frameworks, and tools and


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Table 5.2 Hierarchical conceptualization of the precautionary principle relative to other approaches to decision and policy making in the face of uncertainty Level

Components

1.

Social goal

Sustainability/sustainable development/ESD

2.

Principles (to be further specified and codified in policies and laws)

Precautionary Principle Adaptive Management

3.

Frameworks

Risk management procedures (e.g. AS/NZS 4360) Policy assessment procedures (e.g. SEA) Others (e.g. ISO 14000 series)

4.

Tools and techniques (selected examples, toolkit to be filled)

a) Direct causes and impact: research and monitoring (focused) ● environmental impact assessment ● risk assessment ● extended cost-benefit analysis ● non-market valuation ● performance assurance bonds ● multi-criteria analysis (deterministic) ● mediation, negotiation ● small scale deliberative techniques (e.g. citizens, juries, focus groups) ● population viability analysis ● regulatory safe minimum standards ● court proceedings. ●

b) Indirect causes and impacts: long term research and monitoring ● strategic environmental assessment ● sustainability assessment, integrated assessment ● strategic risk assessment ● social impact assessment ● mediation, negotiation ● multi-criteria analysis (heuristic) ● large-scale deliberative techniques (e.g. deliberative polling, consensus conferences) ● commissions of inquiry ● court proceedings. ●

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techniques. The most operational level of tools and techniques is divided into examples of those most obviously suited to discrete projects and direct causes, and those more suited to higher-order policy assessment and thus indirect causes. There is some overlap between the levels of the hierarchy, such as with legal proceedings and SEA. This hierarchy is propositional and requires further development, but offers a means to increasing mutual understanding. Sustainability as a social goal is still poorly understood, although much clearer now than a decade ago. Particularly, realization is not yet widespread that sustainability is a higher-order social goal – its natural partners are other social goals such as democracy, rule of law, equity, or public health – and it is a generational policy and institutional task not offering instant policy gratification (Connor and Dovers 2004). The PP and adaptive management also require refinement to increase their potential to guide policy and decision makers, as do frameworks for decision making such as risk management. There is much work to be done in refining specific techniques and filling the toolbox in level 4 of the hierarchy, and especially in establishing when each tool is best used. The fact that these tools, and the frameworks and principles above them, are mostly only known and understood by quite small subnetworks of individuals and groups, and arise from distinct disciplines and professions, suggests a task of interdisciplinary and cross-professional communication and increased mutual understanding rather than advocacy of one method over others (see Barnett et al. 2003; Pawson and Dovers 2003). These tasks may be assisted by the further discussion of a hierarchy such as that in Table 5.2, so the relative role and merits of different approaches to policy and decision making in the face of uncertainty can be better considered.

NOTES 1. This chapter consolidates and extends arguments developed in Dovers (2002a; 2005) and Connor and Dovers (2004). 2. Following Wynne (1992), it can also be proposed that, when policy or technological commitments are made on the basis of presumed knowledge underlain by uncertainty, that uncertainty will increase. 3. Public participation is another core sustainability principle, and thus it is assumed here that any assessment process will be transparent and inclusive of interested and affected parties. 4. This is distinct from the onus of proof – who must prove the case that there are or are not serious or irreversible impacts – which the PP is argued to shift further toward the proponent rather than the opponent of a policy change.


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REFERENCES Australia, The Commonwealth (1992), National Strategy for Ecologically Sustainable Development, Canberra: Australian Government Publishing Service. Barnett, J., H. Ellemor and S. Dovers (2003), ‘Interdisciplinarity and sustainability’, in S. Dovers, D. Stern and M. Young (eds), New Dimensions in Ecological Economics: Integrated Approaches to People and Nature, Cheltenham: Edward Elgar. Bond, R., J. Curran, C. Kirkpatrick, N. Lee and P. Francis (2001), ‘Integrated impact assessment for sustainable development: a case study approach’, World Development, 29, 1011–24. Bosselman, K. and B. Richardson (eds) (1999), Environmental Justice and Market Mechanisms, London: Kluwer Law International. Buckley, R. (1998), ‘Strategic environmental assessment’, in A.L. Porter and J.J. Fittipaldi (eds), Environmental Methods Review: Retooling Impact Assessment for the New Century, Atlanta, GA: Army Environmental Policy Institute. Cater, M. (ed.) (1998), Public Interest in National Competition Policy, Sydney: Public Sector Research Centre, University of New South Wales. Cebon, M. (2003), The Australia–US Free Trade Agreement: An Environmental Impact Assessment, Melbourne: OzProspect. Connell, D., S. Dovers and R.Q. Grafton (2005), ‘A critical analysis of the National Water Initiative’, Australasian Journal of Natural Resources Law and Policy, 10, 81–107. Connor, R. and S. Dovers (2004), Institutional Change for Sustainable Development, Cheltenham: Edward Elgar. Cranor, C.F. (1999), ‘Asymmetric information, the precautionary principle, and burdens of proof’, in C. Raffensperger and J. Tickner (eds), Protecting Public Health and the Environment: Implementing the Precautionary Principle, Washington, DC: Island Press. Curran, G. and R. Hollander (2002), ‘Changing policy mindsets: ESD and NCP compared’, Australian Journal of Environmental Management, 9, 158–68. Dovers, S. (1995), ‘A framework for scaling and framing policy problems in sustainability’, Ecological Economics, 12, 93–106. Dovers, S. (1997), ‘Sustainability: demands on policy’, Journal of Public Policy, 16, 303–18. Dovers, S. (2001a), ‘Informing policy and institutions’, in J. Venning and J. Higgins (eds), Towards Sustainability: Emerging Systems for Informing Sustainable Development, Sydney: University of NSW Press. Dovers, S. (2001b), Institutions for Sustainability, Tela paper 7, Melbourne: Australian Conservation Foundation acfonline.org.au/uploads/res_tp 007.pdf (accessed 21 October 2005). Dovers, S. (2002a), ‘Too deep a SEA? Strategic environmental assessment in the era of sustainability’, in S. Marsden and S. Dovers (eds), Strategic Environmental Assessment in Australasia, Sydney: Federation Press. Dovers, S, (2002b), ‘Sustainability: reviewing Australia’s progress, 1992–2002’, International Journal of Environmental Studies, 59, 559–71. Dovers, S. (2005), Environment and Sustainability: A Policy Handbook, Sydney: Federation Press. Dovers, S. and W. Gullett (1999), ‘Policy choice for sustainability: marketisation, law and institutions’, in K. Bosselman and B. Richardson (eds), Environmental Justice and Market Mechanisms, London: Kluwer Law International.

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Dovers, S. and J. Handmer (1995), ‘Ignorance, the precautionary principle, and sustainability’, Ambio, 24, 92–7. Dovers, S. and J. Handmer (1999), ‘Ignorance and the precautionary principle: toward an analytical framework’, in R. Harding and E. Fisher (eds), Perspectives on the Precautionary Principle, Sydney: Federation Press. Dovers, S. and C. Mobbs (1997), ‘An alluring prospect? Ecology, and the requirements of adaptive management’, in N. Klomp and I. Lunt (eds), Frontiers in Ecology, London: Elsevier. Dovers, S. and S. Wild River (eds) (2003), Managing Australia’s Environment, Sydney: Federation Press. Funtowicz, S. and J. Ravetz (1991), ‘A new scientific methodology for global environmental issues’, in R. Costanza (ed.), Ecological Economics: The Science and Management of Sustainability, New York: Columbia University Press. Gibson, R.B., S. Hassan, S. Holtz, J. Tansey and G. Whitelaw (2005), Sustainability Assessment: Criteria, Processes and Applications, London: Earthscan. Goodin, R.E. (1996), ‘Institutions and their design’, in R.E. Goodin (ed.), The Theory of Institutional Design, Cambridge: Cambridge University Press. Goodland, R. (1998), ‘Strategic environmental assessment’, in A.L. Porter and J.J. Fittipaldi (eds), Environmental Methods Review: Retooling Impact Assessment for the New Century, Atlanta, GA: Army Environmental Policy Institute. Gullett, W. (2000), ‘The precautionary principle in Australia: policy, law and potential precautionary EIAs’, Risk: Health, Safety and Environment, 11, 93–124. Gunderson, L., C. Holling and S. Light (eds) (1995), Barriers and Bridges to the Renewal of Ecosystems and Institutions, New York: Columbia University Press. Hamilton, C. (2003), ‘The Resource Assessment Commission: lessons in the venality of modern politics’, in S. Dovers and S. Wild River (eds), Managing Australia’s Environment, Sydney: Federation Press. Hamilton, C. and D. Throsby (eds) (1998), The Ecologically Sustainable Development Process: Evaluating a Policy Experiment, Canberra: Academy of Social Sciences. Hanson, M. (2003), ‘The precautionary principle’, in E.A. Page and J. Proops (eds), Environmental Thought, Cheltenham: Edward Elgar. Jakeman, A.J. and R.A. Letcher (2003), ‘Integrated assessment and modelling: features, principles and examples for catchment management’, Environmental Modelling and Software, 18, 491–551. Lee, K.N. (1993), Compass and Gyroscope: Integrating Science and Politics for the Environment, Washington DC: Island Press. Marsden, S. (2002), ‘Strategic environmental assessment and fisheries management in Australia: how effective is the Commonwealth legal framework?’, in S. Marsden and S. Dovers (eds), Strategic Environmental Assessment in Australasia, Sydney: Federation Press. Marsden, S. and S. Dovers (2002), Strategic Environmental Assessment in Australasia, Sydney: Federation Press. May, P. (1992), ‘Policy learning and policy failure’, Journal of Public Policy, 14, 331–54. National Competition Council (2003), Assessment of Governments’ Progress in Implementing the National Competition Policy and Related Reforms, 3 vols, Canberra: AusInfo. National Competition Council (2004), Legislation Review Compendium, 5th edn., Canberra: AusInfo.


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Partidario, M. and R. Clark (eds) (2000), Perspectives on Strategic Environmental Assessment, Boca Raton: CRC Lewis Publishers. Pawson, E. and S. Dovers (2003), ‘Environmental history and the challenges of interdisciplinarity: an antipodean perspective’, Environment and History, 9, 53–75. Porter, A.L. and J.J. Fittipaldi (eds) (1998), Environmental Methods Review: Retooling Impact Assessment for the New Century, Atlanta, GA: Army Environmental Policy Institute. Productivity Commission (1999), Implementation of Ecologically Sustainable Development by Commonwealth Departments and Agencies, Canberra: AusInfo. Productivity Commission (2000), Microeconomic Reform and the Environment, Melbourne: Productivity Commission. Sadler, B. and R. Verheem (1996), Strategic Environmental Assessment: Status, Challenges and Future Directions, Zoetermeer, Netherlands: Ministry of Housing, Spatial Planning and the Environment. Smithson, M. (1989), Ignorance and Uncertainty: Emerging Paradigms, New York: Springer Verlag. Standards Australia (2000), Environmental Risk Management: Principles and Processes, Sydney: Standards Australia. Wynne, B. (1992), ‘Uncertainty and environmental learning: reconceiving science in the preventative paradigm’, Global Environmental Change, 2, 111–27.

PART II

The Challenges Involved in Implementing the Precautionary Principle

6. The precautionary principle and administrative constitutionalism: the development of frameworks for applying the precautionary principle1 Elizabeth Fisher and Ronnie Harding The precautionary principle is now a common feature of environmental and public health regimes in many different jurisdictions (de Sadeleer 2002, Trouwborst 2002). The process of implementing the precautionary principle has not stopped there however, and in numerous different jurisdictions there has been a focus on developing general frameworks for implementation. Yet while there is a burgeoning literature on the legitimacy of the precautionary principle, there has been very little critical attention given to these frameworks. This is a considerable deficiency in the literature when one considers that they are one of the most important means of operationalizing it. An analysis of these frameworks provides insight into the implications of applying the principle and the challenges involved in that process of application. This chapter is an introductory study of these frameworks and in it we make three points. First, policy makers and commentators need to be aware that developing these frameworks is not merely a matter of formulating practical checklists. Rather, as a framework regulates what is acceptable behaviour it will, by necessity, reflect and promote theories of what is a legitimate role for public administration, or in other words theories of administrative constitutionalism. Second, there is not one single theory of administrative constitutionalism that is promoted by these frameworks. So far, it can be seen that two different theories have tended to dominate the development of frameworks for applying the precautionary principle – the deliberative-constitutive and rational-instrumental theories. These theories differ in the role that they prescribe for public administration and the way in which environmental and public health problems are conceptualized. The theory a framework reflects will determine how that framework 113

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Challenges involved in implementing the precautionary principle

regulates administrative decision making. Third, in the light of the two points above we argue the need for commentators and policy makers to take a far more sophisticated approach to applying the precautionary principle by paying greater attention to the interrelationship between the precautionary principle and administrative constitutionalism. In particular this requires: greater analysis of the administrative implications of the principle; an appreciation that the deployment of the language of accountability, reasonableness, consistency and non-arbitrariness is meaningless without reference to broader theories of administrative constitutionalism; and more consideration of whether frameworks for applying the precautionary principle should be promoting either a deliberative-constitutive or rational-instrumental understanding of administrative constitutionalism. This chapter is structured as follows. In the first section we look at how the precautionary principle is primarily concerned with regulating the process of administrative decision making. What is understood to be a legitimate process in any particular circumstances will not only be determined by the precautionary principle but also by theories of administrative constitutionalism. In the second section we give an overview of frameworks for applying the precautionary principle and how and why they reflect theories of administrative constitutionalism. In the third and fourth sections we examine two frameworks, the content of which can be understood as promoting two different theories of administrative constitutionalism. Deville and Harding’s framework (Deville and Harding 1997) can be understood to reflect a deliberative-constitutive theory while the European Commission’s Communication on the Precautionary Principle reflects a rational-instrumental theory (Commission of the European Communities 2000b). In the fifth section we compare these two frameworks and identify the similarities and differences between them. In the final section, we consider the implications of identifying this link between the principle’s application and administrative constitutionalism. Four caveats should be made before starting. The first is that the two frameworks presented here are merely illustrative of the increasing number of frameworks that have been developed to apply the precautionary principle. Second, theories of good public administration do play a role in all areas of risk regulation and their influence is not limited to applying the precautionary principle (Fisher forthcoming).2 Third, we appreciate that the two frameworks studied here are derived from fundamentally different legal and socio-political cultures and some of the differences between the frameworks are due to differences in those cultures (Fisher 2002). Our comparison, however, is simply in relation to the theories of administrative constitutionalism that underpin the frameworks, and like all theories of constitutionalism the basic tenets of those theories tend to apply across all jurisdictions

The precautionary principle and administrative constitutionalism

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committed to democratic constitutionalism (Alexander 1998, Fisher forthcoming).3 Finally, this chapter is only concerned with frameworks per se and not with how they have been applied in practice. With this said, it should be noted that the practical operation of frameworks will also be heavily influenced by theories of administrative constitutionalism and often result in conflict between such theories (Fisher 2005, Fisher forthcoming).

THE PRECAUTIONARY PRINCIPLE, PUBLIC ADMINISTRATION AND ADMINISTRATIVE CONSTITUTIONALISM The precautionary principle is a principle that requires public decision makers to take scientific uncertainty seriously in the pursuit of the regulatory goals of environmental and public health protection. The principle regulates the reasons for a decision and the process by which a decision is made as opposed to dictating what the outcomes of that process should be (Fisher and Harding 1999, Renn et al. 2003). This is because regulating outcomes (beyond requiring decision makers to pursue broad statutory goals) is logically impossible in cases of scientific uncertainty and because, as seen below, in public life the process and reasons for a decision are the main determinant of that decision’s legitimacy (Richardson 2002). As the principle is concerned with reasons and process it requires decision makers to reflect on how they justify their decisions, what factors are relevant to a decision, how that decision should be made, and who should be involved in the decision-making process. Most formulations of the principle4 state that ‘lack of full scientific certainty should not be used as a reason’ not to take measures and as such they require the decision maker to depart from a norm that has tended to dominate contemporary public life – that a good decision is made on fully ‘proven’ facts and is as objective as possible (Porter 1995). As will be seen below, that norm has been promoted on the belief that such objectivity will restrain discretion and ensure that decision makers are held to account (Fisher 2000). The reason why the precautionary principle requires a deviation from this norm is that in circumstances of scientific uncertainty this norm is invalid and counterproductive. It is invalid because such a simplistic approach to the treatment of scientific evidence ignores the methodological, epistemological and ontological problems inherent in the practice of science when considerable scientific uncertainties exist (Wynne 1992). It is counterproductive because the failure to recognize those problems can result in profoundly flawed decisions (Harremoës et al. 2002a, ShraderFrechette 1993).

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While official formulations of the principle state this negative, very few explicitly state the basis on which decisions should be made. Moreover, while the principle does state that measures should be taken to prevent environmental degradation or human health problems (the regulatory goals of the regimes the principle is mainly included in) it does not prescribe what the nature and extent of such measures should be. This silence reflects the fact that what is deemed to be the appropriate basis for a decision and the appropriate measures to be taken will vary depending on the circumstances (Fisher 2002). It will be influenced by legal and socio-political culture, the specific statutory regime, the nature of particular environmental or public health problems, the availability and ease of implementation of ‘precautionary measures’, and more general understandings of legitimate decision making. In particular, an overwhelming influence on what is understood to be the implications of the precautionary principle for decision making will be its institutional context. In nearly all jurisdictions that institutional context is public administration. This is because the principle applies to the public activities of standard setting and authorization and these are predominantly administrative activities in that they are delegated by a primary law maker to a non-elected secondary law maker. The main reason for this is the highly resource intensive nature of these activities and in particular the need for information, expertise, the application of a normative prescription to a specific circumstance, and the intense communication between involved parties (Fisher forthcoming). The fact that the precautionary principle applies mainly in the realm of public administration has been overlooked in the literature but is crucial in understanding how it is implemented because the administrative nature of decision making will be a key influence on what is understood as legitimate and an appropriate action pursuant to the principle. This is particularly due to the nature of administrative power. As public administration is unelected it sits uneasily in liberal constitutional orders that are committed to democracy. As such the exercise of administrative power needs to be justified and legitimated in accordance with a theory of public administration. In essence, such a theory is a theory of administrative constitutionalism in that it is a theory about how public administration is and should be constituted and regulated so as to ensure legitimate governance (Fisher forthcoming). These theories are not often made explicit but if one identifies the basic assumptions on which a particular law or policy rests then one can see that those assumptions reflect normative ideals about legitimate administration (Mashaw 1997). Indeed there is a close interdependent relationship between law and policy and administrative constitutionalism. The latter will be a foundation for the former and the former will promote the latter (Fisher forthcoming). There is considerable polarization of opinion over theories of


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administrative constitutionalism and thus over the ideal legal and institutional form of public administration (Cook 1996, Fisher forthcoming, Mashaw 2002). While nearly everyone agrees that an unelected administration should be accountable, fair, consistent and non-arbitrary, these terms denote very different understandings of public administration and very different types of law and policy for regulating public administration (Fisher forthcoming). These differences in opinion will clearly be relevant in applying the precautionary principle. Theories of administrative constitutionalism will determine how an administrative decision maker is constituted, regulated and held to account by defining the legitimate role and nature of public administration (Fisher forthcoming). Whether the principle is inserted into an existing regulatory regime or is the basis for a new regulatory regime, these theories will influence what is understood as a legitimate process for applying the precautionary principle. A process would never be deemed to be legitimate if it violated fundamental principles based on these theories. As there are different theories of administrative constitutionalism then it follows that there will be very different approaches to applying the precautionary principle.

THEORIES OF ADMINISTRATIVE CONSTITUTIONALISM AND FRAMEWORKS FOR IMPLEMENTING THE PRECAUTIONARY PRINCIPLE The influence of these theories of administrative constitutionalism can be clearly seen in how the precautionary principle has been applied, whether through the principle’s interpretation in a court case or its inclusion in legislation (Fisher forthcoming, Peel, this book, chapter 10). Where that influence can be seen most obviously however, is in the increasing number of frameworks which have been developed to apply the principle. By framework we mean some form of generic guidance that has as its aim the setting out of a series of decision-making steps for decision makers to follow. These frameworks vary in their legal status and detail and many are only advisory, although arguably they are becoming increasingly entrenched.5 Frameworks have been developed by a wide range of actors including policy makers (Commission of the European Communities 2000b, Government of Canada 2002), academics (often funded by public bodies), (Deville and Harding 1997, Renn et al. 2003) and non-governmental organisations (World Conservation Congress-IUCN 2004). Predominantly, these frameworks are general and apply to a range of decision-making activities across

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government (Commission of the European Communities 2000b, Deville and Harding 1997, Government of Canada 2002, Interdepartmental Liaison Group on Risk Assessment 2002, Renn et al. 2003) although some have been developed in specific areas such as children’s health (World Health Organization 2004), biodiversity (The Precautionary Principle Project 2005) and fisheries (Commission of the European Communities 2000a). There are two main reasons why these frameworks have been developed. The first is a very practical one, which is that such frameworks are an efficient means of informing many different decision makers about how they can and should apply the principle. This is particularly the case for those frameworks which are concerned with decision making in specific areas because the framework is a means of identifying what aspects of a health or an environmental problem are relevant to the application of the principle (World Health Organization 2004). The second and more significant reason, is that such frameworks are a tool for demonstrating the legitimacy of the principle by promoting accountability and consistency through setting out the guidelines by which the principle will be applied. This has been the major reason for the development of such frameworks – a fact that can be evidenced in their general nature and explicit statements by their authors that such frameworks will ensure accountable, non-arbitrary and consistent decisions (Commission of the European Communities 2000b, Deville and Harding 1997, Government of Canada 2002). As already seen above, whether decision making pursuant to a framework is legitimate will not only be determined by the precautionary principle but also by theories of administrative constitutionalism. This is because such frameworks are concerned with ensuring ‘reasonable action’, and what is meant by that term is an issue of administrative constitutionalism. As a consequence of this, a framework will reflect or promote a particular theory of administrative constitutionalism because in giving guidance on how to apply the precautionary principle it must also give guidance on what is legitimate action. By saying that a framework reflects or promotes a particular theory of administrative constitutionalism we are not necessarily saying that this is a conscious act on the part of the framework’s authors. Rather we mean that if we deconstruct these frameworks we can see that they rest on particular assumptions about good administration. The impact of these theories is best shown by example. In the next two sections we examine two frameworks which can be understood to reflect two of the most common theories of administrative constitutionalism that have dominated risk regulation (Fisher forthcoming). The first framework was developed by two academics (Deville and Harding 1997) and is a good example of a framework promoting a ‘deliberative-constitutive’ model of administrative constitutionalism. The second framework was published by the European


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Commission (Commission of the European Communities 2000b) and is a classic example of a framework reflecting a ‘rational-instrumental’ model. As will be seen these two different theories prescribe different roles for public administration and thus have resulted in two very different types of frameworks.

A FRAMEWORK PROMOTING A DELIBERATIVECONSTITUTIVE THEORY OF ADMINISTRATIVE CONSTITUTIONALISM The first framework we examine is that of Deville and Harding, the development and publication of which was funded by the Environmental Education Trust of the New South Wales Government (Deville and Harding 1997). The framework describes itself as providing a ‘user friendly guide’ for a wide range of decision makers. This is particularly important in Australia because while the principle has been commonly included in law and policy there has been very little official elaboration about the principle’s implications for regulatory practices (Harding and Fisher 1994). Deville and Harding require decision makers to engage in a sequential process of four steps which structure thinking about particular environmental problems and the scientific uncertainties involved. Those steps are represented in Figure 6.1. Step One requires decision makers to determine whether precautionary measures are needed and this requires them to address two questions. The first is whether there are threats of serious and irreversible environmental damage and if so where that threat would lie on a rough scale of seriousness and irreversibility. Determining this requires a deliberative process that will draw on a range of views due to the diverse range of issues that need to be considered and actors that need to be consulted. At a minimum, determining whether something is a ‘serious or irreversible threat’ requires consideration of: its spatial aspects; its magnitude; its longevity; its manageability; public concern over it; as well as more general community understandings of what are ‘serious and irreversible threats’. The second question in relation to Step One is ‘how certain are we about threats to the environment?’ Decision makers need to think about the sufficiency of evidence, the level and nature of uncertainty and the feasibility of reducing the uncertainty, and again are required to locate their responses on a rough scale. If the answer to both questions under Step One is ‘yes’ the principle will need to be applied. If it is ‘maybe’ then they may need to review assessment under Step One or proceed through the next three steps anyway. At Step Two the decision maker asks ‘how precautionary should we be?’ (based on how significant the threat is and how much scientific uncertainty

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Yes

Framework for applying the precautionary principle.

Assess the riskweighted consequences of various options

Economic & social costs of measures

Options Develop a range of options based on a number of considerations

Input of the broader community

Step 3: What precautionary measures can be applied? i.e. What measures are available?

Deville and Harding (1997); reproduced with permission.

Figure 6.1

Source:

Some measures should still be applied to take into account ignorance about the effects of our actions

No

Step 1: Are precautionary measures needed?

Step 2: How precautious should we be?

Other ESD principles

Step 4 What precautionary measures should be applied?


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there is regarding cause and effect), and at Step Three ‘what precautionary measures can be applied?’ These questions need to be addressed simultaneously, given that how precautionary a decision maker can be depends in part on what measures are available. Thus for example, in some circumstances ‘easy’ precautionary measures (whether technically, economically and/or socially) will be available while in others they will not. Deville and Harding also require decision makers to think very broadly about the type of measures available to them and stress that such measures may take both a direct and indirect form. To aid the answering of the questions at Steps Two and Three, Deville and Harding suggest plotting the significance of the threat on a vertical axis against the degree of scientific uncertainty about the threat and its effects (horizontal axis), as this gives an indication of how much precaution is appropriate. They also use two ‘rules of thumb’ to guide placement on the graph: (i) the more significant the threat, the greater the precaution required; (ii) the more uncertain the threat, the greater the precaution required (though it is still within the realm of ‘reasonable scientific possibility’). The intersection of the vertical and horizontal axes marks the threshold level for ‘serious or irreversible’ environmental damage and the threshold for sufficient scientific uncertainty to warrant application of the precautionary principle. Hence the quadrant of most relevance to the application of the precautionary principle is the top left hand quadrant. Figure 6.2 illustrates this process. Deville and Harding recognize the need to take constantly into account ignorance and indeterminacy (the problem of we don’t know what we don’t know (Wynne 1992)) throughout this process as well as revisiting the answers developed in relation to Step One. They also stress that these steps will not result in an answer that amounts to a quantified measure of precaution required in a specific situation. Rather, the steps require decision makers to exercise their reasoned judgement after considering the relevant information and the views of an appropriate range of interested parties. Step Four, the final step, requires decision makers to consider what precautionary measures should be applied. This is distinct from Steps Two and Three which considered the level of precaution needed and possible measures. Step Four requires decision makers to consider the broader context and in particular to identify the range of available options taking account of the economic and social costs of measures and other relevant principles. The approach taken in the Deville and Harding framework is typical of those seen in a number of other general frameworks for applying the precautionary principle (Harremoës et al. 2002b, Renn et al. 2003).6 These frameworks have three key features. First, they require decision makers to identify and characterize scientific uncertainties. Second, they require a

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Epistemological uncertainty Uncertainty buffer

Methodological uncertainty

Determining degrees of precaution

Deville and Harding (1997); reproduced with permission.

Figure 6.2

Source:

Increasing scientific uncertainty

Slightly significant

Moderately significant

Strict prevention

Moderate prevention

Known risks

Wellknown

Increasing scientific certainty

Strong prevention

Threat buffer

Weak prevention

Insignificant threat to environment

Technical uncertainty

Weak precaution

Moderate precaution

Strong precaution

Strict precaution

Very significant

Significant threat to environment


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deliberative process in which a wide range of actors (operating across a number of disciplines) are brought together in the problem solving process (Fisher and Harding 1999, National Research Council 1996, Steele 2001) and the outcome of that process is more than the sum of individual preferences (Barron 1994). Third, they require a flexible and recursive process in which the decision-making process is adapted to the problem at hand and in the light of new scientific knowledge (Harremoës et al. 2002b, National Research Council 1996). Indeed, what can be seen is that the Deville and Harding framework, along with these other frameworks, is implying a particular role for public administration which is best described as reflecting a deliberativeconstitutive theory of administrative constitutionalism (Fisher and Harding 1999). The starting point for this theory is that the precautionary principle is applied to environmental and public health problems that are shrouded in scientific uncertainty and thus are physically and sociopolitically complex. This complexity means that such problems cannot be solved by a prescribed formula or quantified algorithm. What is needed is an institutional structure that can deal with the problem in an ongoing manner by first of all developing a process adapted to the problem but which can then also be flexible in the light of new information. Such an administrative structure is best created by constituting a body and giving it reasonably flexible powers to address that problem. Thus for example, under this model ‘threat’ is defined very broadly (Deville and Harding 1997, Renn et al. 2003) and decision makers are required to adjust who is included in the decision-making process depending on the nature of the problem. Likewise, few restrictions are placed on the measures they can take. Superficially this might seem to create an unrestricted mandate for a bureaucracy but the power of decision makers is regulated in two interrelated ways. First, decision makers must take considerable care in describing and characterizing the problem they are addressing. They cannot act without explaining themselves and those duties of explanation, as seen above, are quite onerous. Second, throughout the decision-making process they must deliberate with a considerable number of actors who will not only be helping solve the problem but also questioning the decision maker’s assessment of the problem. This deliberative process is thus both consensual and adversarial (National Research Council 1996). All in all, the deliberative-constitutive theory of administrative constitutionalism conceptualizes public administration as being constituted so as to address a series of problems in as flexible a way as possible and its power is regulated by a deliberative process. This theory has tended to underpin those frameworks for applying the principle where the starting point has

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been a desire to develop an administrative framework that can adequately address the complexities of environmental and public health problems. With that said, it should be appreciated that the deliberative-constitutive theory has a long history in Western democracies in relation to risk regulation and public administration more generally (Cook 1996, Fisher forthcoming, Woodhouse 1997).

A FRAMEWORK PROMOTING A RATIONALINSTRUMENTAL THEORY OF ADMINISTRATIVE CONSTITUTIONALISM One prime example of a risk regulation regime which has been built on the deliberative-constitutive theory of administrative constitutionalism is that of the European Union (EU) with its networks of multilevel problem solvers and its emphasis on deliberative reason (Fisher forthcoming, Joerges 2002). The precautionary principle was included in the Treaty of the European Communities in 1992 and one would expect that a framework for its implementation would promote a deliberative-constitutive theory of administrative constitutionalism. This is not the case, however, and the most significant framework developed by the EU institutions so far7 has been the European Commission’s Communication on the Precautionary Principle (Commission of the European Communities 2000b), which very much reflects rational-instrumental ideals. Before looking at that framework more closely it is useful to explain briefly what we mean by a rationalinstrumental theory. The starting point for this theory is ensuring that there are pre-ordained limits on administrative power (Fisher 2000, Fisher forthcoming). These limits are provided in two ways. First administrative decision makers are characterized as ‘instruments’ of the legislature who are carrying out a set of limited tasks. They are akin to a robotic machine, a ‘transmission belt’, that is understood to be an efficient apparatus with little discretionary power of its own (Stewart 1975, Weber 1991). Second, as this is the case, any discretion they do exercise is regulated by rational methodologies derived from science or social science that ensure that decisions are made on an ‘objective’ basis and constrained by the rigours of methodology so that no other factors, other than those explicitly allowed by the limited legislative mandate, are taken into account. From an historical perspective, the rational-instrumental theory of administrative constitutionalism has tended to dominate legal doctrine because it seemingly ensures that public administration is constrained and controlled (Wade and Forsyth 2000). Likewise, in circumstances where there have been controversies over administrative discretion


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the resulting legal and policy reforms will often reflect rational-instrumental ideals (Fisher forthcoming). The idea of strict legislative control of administrative action is not easily transferable into the EU context (Majone 2002a). With that said, rationalinstrumental ideals are clearly promoted in the European Commission’s Communication on the Precautionary Principle (Commission of the European Communities 2000b). This is due to the two aims of the Communication. First, the Communication had a particular legal purpose in that it was explicitly designed to show that EU decision making pursuant to the precautionary principle was consistent with the Sanitary and PhytoSanitary (SPS) Agreement of the World Trade Organization (WTO). This was viewed as particularly important due to the WTO Appellate Body’s ruling in 1998 that the EC had not acted in accordance with the WTO when the EU banned beef from cattle treated with growth hormones (Majone 2005).8 Second, the Commission stated that its aim in publishing the document was to ensure that the exercise of power pursuant to the principle was non-arbitrary, and one should read the Communication against a background of other policy documents published at the time which had as their theme the accountability of Community institutions (Commission of the European Communities 2000c, 2001, 2002). In both cases, this led to an approach to controlling ‘administrative’9 action based on rational instrumental ideals. In the Communication decision makers are understood to be carrying out a series of discrete tasks and environmental and public health decision making is characterized as a three-step process: a scientific process of risk assessment; a political process of risk management; and a process of risk communication.10 The Commission states that the principle only applies to the second of these steps but the Communication also lays down prescriptions for the first step. It states that the principle only applies when a risk assessment has identified a ‘potential risk’ and the uncertainties surrounding it. Such a risk assessment ‘requires reliable scientific data and logical reasoning, leading to a conclusion which expresses the possibility of occurrence and the severity of a hazard’s impact on the environment, or health of a given population including the extent of possible damage, persistency, reversibility and delayed effect’ (Commission of the European Communities 2000b). While it is recognized that scientific uncertainty may make this problematic the Communication stresses that as ‘complete a comprehensive assessment of risk’ should be made as possible. Risk assessment is defined in strict procedural terms as consisting of hazard identification, hazard characterization, appraisal of exposure and risk characterization.11 The Communication is mainly silent on how scientific uncertainty should be identified and communicated as part of the risk

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assessment process. The Commission does however, state that any ‘prudential’ approach of taking into account scientific uncertainty as part of the risk assessment process is distinct from the application of the precautionary principle. When a risk assessment does identify a potential ‘negative effect’ after a scientific evaluation has been done then, as part of risk management, there must be a decision to act or not to act and the precautionary principle will directly apply to this. In deciding this question, the Communication stresses the need for there to be an assessment of the uncertainties involved in the evaluation and an assessment of the possible consequences of inaction or waiting for more scientific information. The process of applying the principle must be transparent and inclusive, particularly in assessing the consequences of different forms of action and inaction. The Communication, however, describes this as a ‘political decision’ and provides few guidelines for this process of evaluation. What the Communication does do, however, is set out a series of standards by which the measures to be taken must be judged. Any measures taken pursuant to the principle must be proportional, non-discriminatory, consistent, based on an examination of potential costs and benefits, subject to revision in the light of new data and capable of assigning responsibility for the production of more scientific evidence.12 These can be roughly understood as a duty to carry out a form of regulatory impact assessment. The Communication is thus creating a rigid framework for decision makers to follow if they wish to apply the precautionary principle. Decision makers are being assigned two specific tasks of assessing and managing risks and in regards to each, discretion is constrained by methodologies such as risk assessment and regulatory impact assessment. Not only must a decision maker use those methodologies in making those decisions but a decision made pursuant to those methodologies is held to be valid because so long as a decision maker has followed these pre-ordained processes a decision is held to be within the power of the decision maker. There is none of the process of explanation as required by Deville and Harding. Rather the framework dictates what methodologies must apply and assumes that those methodologies will make those decisions legitimate.

COMPARING THE TWO FRAMEWORKS At a certain level of generality these two frameworks have a number of common features. First, both regulate the process of administrative decision making. Second, that process is to be transparent and inclusive. Third, they require decision makers to have reference to various types of infor-


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mation and factors including science and normative values. Fourth, the application of the principle can result in a range of different measures. Fifth, the purpose of both frameworks is to ensure legitimate decision making and thus they are seen as an aid to ensure accountable and public administration. Regardless of what theory of administrative constitutionalism underpins a framework, these are universal features of frameworks for applying the principle. This is important to note because these similarities are evidence to counteract those that argue that applying the principle results in a no-risk strategy that is anti-science and arbitrary (Cross 1996, Majone 2002b, Sunstein 2005). Where the frameworks diverge considerably however is in what is understood to be legitimate decision making because they reflect distinct theories of administrative constitutionalism. These divergences manifest themselves in five ways. First, the two frameworks conceptualize environmental and public health problems differently. For Deville and Harding those problems are complex and often intractable and thus require an institutional framework that can adapt to specific problems. For the Commission those problems are inherently manageable by methodologies and thus what is required is an institutional framework that ensures that decision makers carry out pre-ordained tasks. Second, the frameworks characterize the decision-making process differently. For Deville and Harding the process is not divided up into separate scientific and political processes because the complexity of environmental and public health problems, particularly in circumstances of scientific uncertainty, does not allow such a division. In the Communication, the process is divided up in this way because it seemingly ensures that decision makers are carrying out clearly defined tasks. This division also reflects what was perceived to be the legal obligations imposed by the SPS Agreement (Button 2004). The third way that these two frameworks diverge is that, while both require decision making to be inclusive and transparent, they do so for different reasons. For Deville and Harding one of the major reasons for broadening the range of participants and for transparency is to promote the effectiveness of the decision-making process by promoting deliberation. Ideally participants should have an array of expertise, experience and perspectives, and the transparency of the process allows them to evaluate the nature of the problem and contribute to the deliberative process (Fisher and Harding 1999). In contrast, for the Commission, the purpose of transparency is about showing that decision makers have carried out the methodological tasks assigned to them. Likewise, participant involvement is mainly limited to risk management where it would seem that interested parties are registering their preferences more than actually participating in a deliberative process (Stewart 1975).

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Fourth, each framework regulates different aspects of the decisionmaking process and thus requires decision makers to justify their decisions in divergent ways. Deville and Harding are primarily concerned with ensuring that decision makers examine the scientific uncertainties involved in any environmental or public health problem and that they carefully identify and evaluate the range of options that can and should be applied. This is important because if a decision maker does not do this properly then deliberation cannot occur and decision makers cannot properly justify the measures they wish to take. Their model is placing a burden on decision makers to show how they have evaluated the specific features of the environmental or public health problem at hand and to justify their methodologies and measures on that basis. The focus is on the substantive reasons given for the decision and how those reasons relate to the problem and the deliberative process. In contrast, the Communication does not place such specific duties of evaluating a problem on a decision maker. Rather, a decision will be presumed to be valid if a decision maker has adhered to risk assessment methodology and if the measures that a decision maker propose are judged against standards such as proportionality and non-discrimination. In other words, a decision will be justified if it accords with a pre-determined methodology and set of standards. Fifth and finally, these two frameworks have differing purposes. Deville and Harding’s terms of reference required them to show how the precautionary principle could be practically applied across the very different legal and institutional contexts of local, state and Federal government in Australia. Their starting point is essentially a blank sheet and a question – what is the best administrative process for addressing uncertain environmental and public health problems? It is only in their Step Four that they have to reconcile that process with existing legal obligations. In contrast, the European Commission’s terms of reference were dictated by concerns over the accountability of EU institutions and by the WTO rulings on hormones.13 Their starting point is showing that a decision maker who applies the principle is complying with legal obligations in both EU and WTO law and that the principle does not result in the exercise of unconstrained power. As already shown, these five differences are because each framework promotes a different theory of administrative constitutionalism and because of the fundamentally different roles that the deliberative-constitutive and rational-instrumental theories assign to public administration. The differences between these two models and frameworks are summarized in Table 6.1. As is clear from above, the difference between these two theories is not a difference between a technocratic and participatory theory of democracy but rather a difference between theories of public administration. Both


Table 6.1

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Comparing the frameworks Deville and Harding (1997)

European Commission’s Communication (2002)

Relevant Theory of Administrative Constitutionalism

Deliberative-Constitutive

Rational-Instrumental

Role and Nature of Public Administration

Institution constituted with broad deliberative powers that can be adapted to the problem at hand

Instrument of legislature that carries out a limited set of tasks on the basis of a rational methodology

Characterization of Problems Being Regulated

Socio-politically and physically complex

Manageable by methodologies

Nature of Administrative Process

Scientific analysis and deliberation combined

Division between scientific and political processes

Nature of Public Participation

Contributing to a Aid to accountability deliberative problem-solving and a means of process identifying preferences

Basis for Justifying Decisions

Reasons and deliberation

Catalyst for Developing Showing how the principle the Framework can be implemented in any institutional setting

Showing that a decision maker adhered to predetermined methodologies and standards Showing that action pursuant to the principle is accountable and consistent with preexisting legal obligations

theories give a role to science and participation but define those differently. This is because each theory assigns a different role to public administration and characterizes the nature of environmental and public health problems differently.

THE PRECAUTIONARY PRINCIPLE AND ADMINISTRATIVE CONSTITUTIONALISM In this last section we identify what we see as the three most significant implications of identifying the interrelationship between the precautionary

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principle and administrative constitutionalism. We do not see these three implications as exhausting possible lines of inquiry but they do highlight a considerable deficiency in the present literature on the principle. First, what is clear from the above is that there needs to be far greater appreciation on the part of both policy makers and commentators that the precautionary principle is primarily operating within the administrative context and that this context will influence how the principle is interpreted and how it is applied. While the literature on the precautionary principle has grown exponentially, this aspect of its application has been virtually ignored. Rather the principle tends to be either examined in analytical terms (Stewart 2002, Sunstein 2005), evaluated in legal terms (Christoforou 2002) or thought of as a universal regulatory strategy (Wiener and Rogers 2002). The fact that it is mainly applied by administrative decision makers and raises issues of administrative legitimacy has been largely overlooked. This is somewhat ironical when one considers that many of the most outspoken critics of the principle are administrative lawyers and scholars and that their primary anxiety is that the principle will be a mandate for arbitrary action (Majone 2005, Marchant and Mossman 2004, Sunstein 2005). A further consequence of needing to examine the administrative context of the principle’s application more carefully is that there is also a need to pay more careful attention to legal and socio-political culture – something which is beyond the scope of this essay but the impact of which can be seen in other papers in this collection (Peel, chapter 10, Tickner and Kriebel, chapter 3). Far too much of the literature on the principle has taken the form of ‘precaution spotting’ rather than of a methodologically rigorous analysis of the principle in specific contexts (Fisher 2002). This is particularly the case in the EU with its novel institutional forms. Moreover, any study would also need to consider how frameworks operate in practice, particularly as the relationship between theory, law and practice is such a vexed one (Fisher and Schmidt 2001). Thus for example a framework may be operating in a context shaped by a different theory of administrative constitutionalism from the one that the framework is based on, this may affect the way the framework is interpreted and operates, and also result in decision makers being subject to contradictory commands (Fisher forthcoming). Second, while both frameworks and the literature on the precautionary principle are preoccupied with ensuring that action pursuant to the principle is accountable, reasonable, consistent and non-arbitrary, these terms are meaningless without reference to broader theories of administrative constitutionalism. These terms mean different things depending upon what theory is being applied. Thus for example, while it may be reasonable to assess environmental harms and the possible measures


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to be taken simultaneously under the deliberative-constitutive theory it would not be under the rational-instrumental theory because it would be blurring a set of clearly defined roles. Likewise, while under the rationalinstrumental theory there may be a preoccupation with assessing the outcomes of the decision-making process so as to ensure accountability, this would seem misguided under the deliberative-constitutive theory because a decision is deemed to be accountable if a decision maker can demonstrate a careful evaluation of the problem and appropriate deliberation. Scholars and policy makers need to be aware that there may be sharp disagreements about the principle which arise not from anything inherent in the principle itself but from the theory that is being deployed in its application. Thus for example, Cass Sunstein has been an opponent of the precautionary principle because, among other things, he sees it threatening his vision of the ‘cost-benefit’ administrative state (Sunstein 2005). Third, and finally, an issue raised by the above analysis is whether a particular theory of administrative constitutionalism is a superior basis for developing frameworks for applying the precautionary principle. On a first examination it would seem that the deliberative-constitutive theory would serve that role better because it recognizes that public administration, in pursuing environmental and public health protection, cannot only act on the ‘facts’, when these are uncertain, and needs to adapt decision-making processes to the problem at hand. Indeed, Deville and Harding’s framework would appear to promise more accountable decision making than the Commission’s communication because it forces decision makers to proffer explicit detail about the uncertainties they are dealing with and the options available to them. In contrast, because the rational-instrumental theory is so preoccupied with constraining administrative discretion by rational methodology, it requires them to carry out a risk assessment even when it might not be appropriate to do so. It also tends to require an assessment of outcomes even when they cannot easily be assessed in circumstances of scientific uncertainty (Lee 2005). As this is the case, it is not surprising that advocates of the principle have tended to promote deliberative-constitutive theories and be critical of approaches promoting rational-instrumental ideals (Stirling 2003). With that said, the above analysis does highlight that the issue is not a straightforward one. It may be the case that the role and nature of public administration will vary depending on the nature of the risk involved and that the more uncertain the risk then the greater the tendency towards promoting deliberative-constitutive ideals in regulation. Likewise, different actors will tend to promote different theories and crudely speaking, the deliberative-constitutive theory tends to be the choice of policy makers while

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the rational-instrumental paradigm tends to be the choice of lawyers. This fact is reflected in the way that the purpose of a framework will influence what theories of administrative constitutionalism will be promoted by that framework. The reason why the Commission’s Communication reflected a rational-instrumental theory was because that accorded with existing legal obligations and because of its legal appeal in the light of accountability concerns in the EU. For certain actors, and in particular legal actors, it offers the best guarantee of ‘good’ administration. This is even though the accountability it offers may be invalid in circumstances of scientific uncertainty and that a framework based on the deliberative-constitutive theory would arguably deliver more accountable and more reasonable decisions.

CONCLUSION As stressed at the outset, this chapter is only an introductory study of frameworks for applying the principle and in it we have sketched a series of ideas that need further elaboration and research. What we have sought to show however is that the challenges involved in applying the precautionary principle can only be properly understood when one appreciates that it largely applies in an administrative context and thus raises issues of administrative legitimacy, or in other words administrative constitutionalism. Theories of administrative constitutionalism will influence the process of developing frameworks for applying the principle and we showed how frameworks will vary depending on whether they reflect a deliberativeconstitutive or a rational-instrumental theory of administrative constitutionalism. Finally, we argued that there is a need for scholars and policy makers to take a far more sophisticated approach to thinking about the principle’s application because that process of application is not about writing a checklist or carrying out an algorithm but rather about developing the institutional capacity for effective and legitimate decision making in circumstances where there is considerable polarization over what these terms mean.

NOTES 1.

This chapter has evolved from a paper that was delivered at a conference, The Precautionary Principle in Environmental Regulation: Ten Years Since Leatch (supported by the Australian Centre for Environmental Law, ANU and the Centre for International and Public Law) that was held at the Australian National University in 2003. We thank the participants at that conference as well as Judith Jones and René von Schomberg for feedback on earlier drafts of this chapter. Any error or omission remains our own.

The precautionary principle and administrative constitutionalism 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

13.

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Compare National Research Council (1983) and National Research Council (1996). This is even the case in the EU, where despite its sui generis nature, the principles of constitutionalism dominate discussion about the legitimacy of its institutions. See Weiler and Wind (2003). For examples of those formulations see Harding and Fisher (1999) at Annex One and Trouwborst (2002). Thus for example the European Court of Justice has given considerable legal weight to the European Commission’s Communication. See Case T-13/99 Pfizer Animal Health SA v. Council [2002] ECR II-3305. It should also be noted that this approach can also be seen in more general risk regulation frameworks. See National Research Council (1996) and Royal Commission on Environmental Pollution (1998). The statement by the European Council is also important to consider and it reflects more deliberative-constitutive ideals. See European Council (2000). Appellate Body Report, European Communities – Measures Concerning Meat and Meat Products (Hormones), 16 January 1998, WT/DS26/AB. See Paulwelyn (1999). Acknowledging the profound difficulty of using this term in the EU context. See Lindseth (2001). This characterization is a direct product of earlier accountability crises in public administration where the division between science and politics was perceived as a way of ensuring that decision makers did not usurp power Fisher (2006) This definition is derived from National Research Council (1983) This list broadly reflects requirements in WTO and EU law but there is no recognition of that fact in the Communication, or of the fact that these concepts are jurisprudentially complex and defined differently in WTO and EU law. For an example of the differences see de Búrca (2002). See note 8.

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Cook, B. (1996), Bureaucracy and Self Government: Reconsidering the Role of Public Administration in American Government, Baltimore: Johns Hopkins University Press. Cross, F. (1996), ‘Paradoxical perils of the precautionary principle’, Washington and Lee Law Review, 53, 851–925. de Búrca, G. (2002), ‘Unpacking the concept of discrimination in EC and international trade law’, in C. Barnard and J. Scott (eds), The Law of the Single European Market: Unpacking the Premises, Oxford: Hart Publishing, pp. 181–96. de Sadeleer, N. (2002), Environmental Principles: From Political Slogans to Legal Rules, Oxford: Oxford University Press. Deville, A. and R. Harding (1997), Applying the Precautionary Principle, Sydney: Federation Press. European Council (2000), Council Resolution on the Precautionary Principle, Nice European Council Meeting: Presidency Conclusions. Fisher, E. (2000), ‘Drowning by numbers: standard setting in risk regulation and the pursuit of accountable public administration’, Oxford Journal of Legal Studies, 20, 109–30. Fisher, E. (2002), ‘Precaution, precaution everywhere: developing a “common understanding” of the precautionary principle in the European Community’, Maastricht Journal of European and Comparative Law, 9, 7–28. Fisher, E. (2005), ‘Precaution, law and principles of good administration’, Water Science and Technology, 52, 19–24. Fisher, E. (2006), ‘Risk and environmental law: a beginner’s guide’, in B. Richardson and S. Wood (eds), Environmental Law for Sustainability: A Critical Reader, Oxford: Hart Publishing, pp. 97–125. Fisher, E. (forthcoming), Risk Regulation and Administrative Constitutionalism, Oxford: Hart Publishing. Fisher, E. and R. Harding (1999), ‘The precautionary principle: towards a deliberative, transdisciplinary, problem-solving process’, in R. Harding and E. Fisher (eds), Perspectives on the Precautionary Principle, Sydney: Federation Press, pp. 290–98. Fisher, E. and P. Schmidt (2001), ‘Seeing the blindspots in administrative law: theory, practice, and rulemaking settlements in the United States’, Common Law World Review, 30, 272–96. Government of Canada (2002), A Framework for the Application of Precaution in Science-based Decision Making about Risk, Ottowa: Government of Canada. Harding, R. and E. Fisher (1994), ‘The precautionary principle in Australia’, in T. O’Riordan and J. Cameron (eds), Interpreting the Precautionary Principle, London: Earthscan, pp. 252–61. Harding, R. and E. Fisher (eds) (1999), Perspectives on the Precautionary Principle, Sydney: Federation Press. Harremoës, P., D. Gee, M. MacGarvin, A. Stirling, J. Keys, B. Wynne and S. Guedes Vaz (eds) (2002a), The Precautionary Principle in the Twentieth Century: Late Lessons From Early Warnings, London: Earthscan. Harremoës, P., D. Gee, M. MacGarvin, A. Stirling, J. Keys, B. Wynne and S. Guedes Vaz (eds) (2002b), ‘Twelve late lessons’, in P. Harremoës et al. (eds), The Precautionary Principle in the Twentieth Century: Late Lessons From Early Warnings, London: Earthscan, pp. 185–215. Interdepartmental Liaison Group on Risk Assessment (2002), The Precautionary Principle: Policy and Application, London: ILGRA.


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Negotiating Environmental Change: New Perspectives From Social Science, Cheltenham, UK and Northampton, MA, USA: Edward Elgar, pp. 33–76. Sunstein, C. (2005), Laws of Fear: Beyond the Precautionary Principle, Cambridge: Cambridge University Press. Trouwborst, A. (2002), Evolution and Status of the Precautionary Principle in International Law, The Hague: Kluwer International. Wade, W. and C. Forsyth (2000), Administrative Law, Oxford: Oxford University Press. Weber, M. (1991), From Max Weber: Essays in Sociology, London: Routledge. Weiler, J. and M. Wind (eds) (2003), European Constitutionalism Beyond the State, Cambridge: Cambridge University Press. Wiener, J. and M. Rogers (2002), ‘Comparing precaution in the United States and Europe’, Journal of Risk Research, 5, 317–49. Woodhouse, D. (1997), In Pursuit of Good Administration: Ministers, Civil Servants and Judges, Oxford: Clarendon Press. World Conservation Congress-IUCN (2004), Applying the Precautionary Principle in Environmental Decision-Making and Management, CGR3.REC008. World Health Organization (2004), Dealing With Uncertainty: How Can the Precautionary Principle Help Protect the Future of Our Children?, EUR/04/ 5046267/11, available at www.euro.who.int/document/hms/edocll.pdf (accessed 21 October 2005). Wynne, B. (1992), ‘Uncertainty and environmental learning’, Global Environmental Change, 2, 111–27.

Cases Appellate Body Report, European Communities – Measures Concerning Meat and Meat Products (Hormones), 16 January 1998, WT/DS26/AB. Case T-13/99 Pfizer Animal Health SA v. Council [2002] ECR II-3305.

7. The burden and standard of proof in environmental regulation: the precautionary principle in an Australian administrative context Judith Jones and Simon Bronitt1 1.

INTRODUCTION

Textual formulations of the precautionary principle or precautionary approaches within legislation in Australia vary (Stein 2000). Most have been derived from Principle 15 of the Declaration on Environment and Development (12 August 1992). The progenitor Australian version of precaution was that contained in the 1992 Intergovernmental Agreement on the Environment (IGAE, 1992), between the Commonwealth and the States and Territories, which stated (at 3.5.1): Precautionary principle – Where there are threats of serious or irreversible environmental damage, lack of full scientific certainty should not be used as a reason for postponing measures to prevent environmental degradation. In the application of the precautionary principle, public and private decisions should be guided by: i. careful evaluation to avoid, wherever practicable, serious or irreversible damage to the environment; and ii. an assessment of the risk-weighted consequences of various options.

The terminology of burden of proof and standard of proof do not appear within this or in the other familiar texts of the precautionary principle. This is true of all current Australian legislative forms of the principle of precaution. Yet the term ‘burden of proof’, familiar in legal doctrine from the courtroom context, has subsequently been considered and accepted as a core conceptual component of the precautionary principle, internationally and in Australia (Stein 2000, Cameron 2001, Bates 2002, Farrier, Whelan and Brown 2002). The companion to burden of proof in the courts, namely, the standard of proof, has also appeared in the Australian discourse on the precautionary principle (Farrier 1999, Whitehouse 1999, Bates 2002, Nagorcka 137

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2003). Issues of fact finding of environmental damage have been at the core of application of the precaution and the precautionary principle, either under the guise of discussion of a threshold test (Stein 2000, Farrier, Whelan and Brown 2002), or in relation to triggering the application of the precautionary principle. This chapter neither challenges nor advocates the use of courtroom terminology or conceptions of proof in precautionary administration. Rather, it is a preliminary exploration to assess the utility of courtroom evidential concepts to implementation of precaution by administrative bodies. Nonetheless, an overarching question remains: how central to precaution should evidential concepts such as burden of proof, standard of proof (or indeed any additional evidential concepts) be? In this chapter (section 2) we consider burden of proof and standard of proof, not only in terms that are familiar from criminal and civil litigation, but more particularly as they can or might relate to fact finding in a precautionary context. We then discuss the manner and extent to which these concepts have emerged in precaution within Australian contexts including law making (section 3), administrative decision making (section 4), judicial and merit review of administrative decision making (section 5) and statutory construction (section 6). Finally, we conclude with comment on mechanisms and approaches that may contribute to the further evolution of evidential concepts within administrative fact-finding processes in order to meet precautionary objectives.

2. EVIDENTIAL CONCEPTS RELEVANT TO PRECAUTION: BURDEN OF PROOF AND STANDARD OF PROOF Notably, Cameron (2001) says: ‘common to all precautionary measures is a shifting of a burden of proof’. The notion of a precautionary shifting of the burden of proof is also well recognized in WTO jurisprudence and commentary (McDonald, this book, chapter 8). What is meant is that the precautionary principle has caused a party who customarily has not had the burden to have it now. But, in Australia at least, to focus simply on the use of the term ‘shifting’, at least in a legal sense, is somewhat misleading. It is now accepted that the correct way to view what is in fact a burden to prove something, is for the burden to be located on a party (Bronitt and McSherry 2005). When that party proves whatever it is, then the burden to prove something else is placed on another party. The burden of proof has been considered within the Australian environmental law discourse on precaution. In an administrative context, once the threshold test of the precautionary principle has been satisfied, the

The burden and standard of proof in environmental regulation

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applicant for a licence, for example, has the burden to demonstrate that the activity does not threaten environmental damage (Farrier 1999). Ordinarily, in the absence of precaution, an objector arguing that a development ought not proceed on environmental grounds would have an obligation to produce evidence of the failure by a party (applicant or agency) to discharge statutory obligations. The traditional obstacle for an objector, as noted by Bates (2002), is that in matters of environmental damage, what is likely to be required is a considerable weight of scientific evidence to prove the alleged environmental damage. Such scientific evidence, particularly conclusive evidence, may not be available to the objector, or indeed, to anyone. Consequently, it has typically been difficult, in evidential terms, for objectors to challenge such decisions. Precaution, it has been argued, has the potential to strike at the heart of this evidential problem by modifying the burden of proof that objectors must satisfy. Bates (2002) argues that application of precaution modifies the burden of proof in civil proceedings so that all that an objector needs to establish is a prima facie case. The analogy between the burden of proof in criminal law and the core elements of the precautionary principle is striking, as illustrated by Table 7.1. We do not mean to suggest that they are one and the same thing. Indeed, closer analysis of the individual components reveals a number of fundamental differences in the way each legal principle operates, which are worthy of further exploration but are beyond the scope of this chapter. Nonetheless, this comparison serves to illustrate the attraction and potential applicability of burden of proof and other evidential concepts to precautionary discourse. What indeed is the origin and meaning of the notion of a burden of proof ? In criminal law the burden of proof, sometimes referred to as the onus of proof, flows from the ‘presumption of innocence’, which is a fundamental human right protected by Article 14(2) of the International Covenant on Civil and Political Rights (Bronitt and McSherry 2005, p. 113). Rather than assuming that a person charged with an offence is innocent, in fact, this presumption operates ‘as a formal caution to those parties concerned with guilt determination – judges, lawyers and jurors – that the prosecution (usually the State) has to prove guilt, rather than the defence having to prove innocence’ (Bronitt and McSherry 2005, p. 113). Although often viewed as an evidential concept, the question of where the burden lies in relation to a particular matter is not a question determined by the rules of evidence. Rather, the location of the burden is a substantive law question, discovered by interpretation of the provisions of the relevant statute (Australian Law Reform Commission 1985, p. 15). In many environmental regimes, the obligation on applicants to comply with statutory provisions to provide factual information and on decision makers to be independently

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Table 7.1 Comparison between the core concepts of precaution and the elements of criminal burden of proof in criminal proceedings

Party

Ultimate Issue

Precaution (adapted from IGAE, 1992)

Criminal Burden of Proof (Bronitt and McSherry, 2005)

Policy maker or administrative decision maker Where there is (1) a threat of serious or irreversible environmental damage (and)

Crown Prosecutor

Standard of Proof

(2) a lack of full scientific certainty

Disposition

this ought not postpone (cost-effective) measures by the decision maker to prevent environmental degradation

Where there is (1) a trial to determine whether Crown or prosecutor has proved its case (elements of offence and rebut defences) in criminal proceedings (and) (2) a failure by the Crown or prosecutor to meet a standard of proof beyond reasonable doubt the decision maker (judge/jury)is required to acquit the accused

satisfied of factual matters is statutorily mandated. Which party, in the process of policy making, administrative decision making or court proceedings, has the obligation to satisfy or be satisfied of something, or indeed to prove or disprove something? What is it that they need to prove? It is important to note that there is not one kind of burden that shifts around. Rather, those burdened are under a burden to prove different things. As each burden is discharged, yet another burden is created. While there may be similarities in relation to what they are seeking to show, they are separate and multiple burdens. A number of commentators have also referred to standards of proof in the context of precaution (Farrier 1999, Whitehouse 1999, Bates 2002, Nagorcka 2003). The notion of standards of proof in the courtroom exists to determine ‘the quantum or level of proof: how much evidence is required to convict the accused?’ (Bronitt and McSherry 2005, pp. 119ff). The Australian courts have traditionally worked with two broad standards of proof – although a simplistic dichotomous characterization is perhaps no longer appropriate. These have been ‘beyond reasonable doubt’, historically adopted as the criminal standard, and ‘on balance of probabilities’, the civil


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standard. Any judicial elaboration of the criminal standard has been discouraged and it is usually explained as a standard of proof not requiring absolute certainty and as being stricter than the second (historically civil) standard ‘balance of probabilities’. Importantly, these legal standards fall short of requiring absolute proof, with both standards accommodating and acknowledging that factual certainty is an impossibility. Consistent with this approach, legal standards of proof bear an uneasy relation to mathematical notions of proof (Heydon 2004, p. 307). The common law has been reluctant to assign numbers or probabilities to represent ‘degrees of proof’ other than to explain, in the broadest terms, the balance of probabilities (Bronitt and McSherry 2005, p. 120). A burden (to meet a threshold standard) of proof can be placed on a party to adduce some evidence in relation to a matter not related to the ultimate out-come. For example, in committal proceedings (an exercise in administrative rather than judicial review) for the matter to proceed to trial the Crown must establish a prima facie case (Grassby v. The Queen (1989) 168 CLR 1 at 15–16 per Dawson J). In criminal law, at least in theory, the prima facie case is intended to constrain the power of the prosecution and to filter out weak cases – the purpose of the prima facie case being to justify the significant imposition that is being placed by the prosecution on the defendant, to defend him/herself. There also exists another type of burden termed the evidential or tactical burden, which is distinct from the legal burden discussed above. The evidential burden may be placed on one of the parties in criminal proceedings to adduce some evidence to support a particular claim. For example, in relation to defences, the evidential burden is placed on the accused – this operates as a threshold burden that screens out frivolous claims and relieves the prosecution of the burden to rebut all possible defences however fanciful and incredible (Bronitt and McSherry 2005, p. 119). Environmental law commentators in Australia have suggested a number of different precautionary standards of proof. Bates (2002, pp. 133–134) considers that there is ‘no clear guidance’ on the requisite standard of proof but he captures aspects of the familiar civil and criminal standards of proof in his favoured approach, suggesting that an objector would be required to: ‘bring forward legitimate scientific evidence that raised the possibility of serious or irreversible environmental damage. The [applicant] would then be required to disprove the probability of such harm beyond reasonable doubt’. Bates suggests that the standard of proof for the objectors’ case would be a ‘possibility’, something lower than even the civil standard ‘on the balance of probabilities’ which means ‘51 out of 100 per cent’ – in which case a mere ‘possibility’ (as Bates suggests) would be less than 50 per cent. Once an objector has satisfied the threshold standard of proof, Bates suggests that

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the respondent (applicant or agency) must meet the higher criminal standard of proof, beyond reasonable doubt. This is a very onerous standard – but perhaps one that is justified on environmental grounds since precaution is applied only where there is the prospect of serious or irreversible environmental damage. Bates argues that the standard, beyond reasonable doubt, is close to the scientific standard – which is commonly set at 95 per cent, that is, so that scientists can be 95 per cent confident that the results of the study are correct. But the courts are reluctant to assign statistical values to these concepts, preferring a ‘context dependent’ standard (Bronitt and McSherry 2005, p. 122). This reluctance may be related to two reasons; first, the practical difficulties for tribunals in applying theories of probability such as the competing Frequentist and Bayesian methods for quantitative assessments (Adelman 2004), which themselves remain complex and controversial, and, secondly, the successful appeals against decisions where courts have utilized statistical approaches in jury directions (see further Hunter, Cameron and Henning 2005, pp. 1024–1034 and Ligertwood 2004, pp. 12–36). An alternative standard, and one that we have argued might have potential for precaution, is the civil standard in which contextual factors become relevant (Jones and Bronitt 2003). The civil standard of proof has been held to be case- or context-dependent. What constitutes the amount of proof necessary for ‘reasonable satisfaction’ in a civil matter varies, as Justice Dixon in Briginshaw v. Briginshaw (1938) 60 CLR 336 at 361–362 observed: But reasonable satisfaction is not a state of mind that is attained or established independently of the nature and consequence of the fact or facts proved. The seriousness of an allegation made, the inherent unlikelihood of an occurrence of a given description, or the gravity of the consequences flowing from a particular finding are considerations which must affect the answer to the question whether the issue has been proved to the reasonable satisfaction of the tribunal.

This conception suggests that the standard of proof demanded by the courts will differ according to the gravity of consequences. It is precisely because this Briginshaw standard of proof varies in accordance with consequences, and because the precautionary principle is applicable where there is the prospect of serious or irreversible consequences, that we argue that it has potential. To offer an example in a precautionary context, where there is a prospect of serious or irreversible consequences, and thus the developer bears the burden of excluding this risk, the standard of proof that should be applied by the tribunal would be higher than the unmodified civil standard (namely, balance of probabilities) that ordinarily applies. It has also been suggested that a unique standard of proof, such as ‘on the balance of scientific opinion’ or ‘beyond reasonable environmental


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concern’ ought to be developed (Nagorcka 2003). Whatever the standard adopted, it is important to recognize, as Bates does, that the threshold standard of proof ought to be ‘lower’ than the ultimate standard of proof that needs to be satisfied. Of course, this is only true in circumstances where the applicant for merit review is a third party objector. Where the applicant for merit review is a disappointed proponent, then, applying the intent behind precaution, the standards of proof should be reversed. See further Gullett (this book, chapter 9), who also considers the standard of proof (or to use his formulation ‘degree of proof’) in these circumstances. In none of these formulations have commentators considered how different definitions of risk may relate to the precautionary principle. Risk in scientific terms tends to be measured in terms of the likelihood of a harmful event occurring, combined with consideration of the magnitude of the harmful consequences. Factual uncertainty can be related both to the likelihood or consequences of a harmful event, which in turn informs the uncertainty of the risk overall. The importance of adopting a binary understanding of risk is apparent from the facts of a criminal case in Victoria involving ‘murder by Russian roulette’ (R v. Faure [1999] 2 VR 537). The accused and his girlfriend agreed to take two turns each at firing a sixchambered revolver containing a single bullet, spinning the chamber between pulling the trigger. On the fourth turn, the gun discharged, killing the girlfriend. At trial there was evidence that the probability of the gun discharging was 671/1296. On a likelihood approach, one could say this game involves an ‘odds on’ chance of death or injury, but not a high risk of death or serious injury. However consideration of the consequences that flow from this activity suggest that the risk should be viewed more seriously. The judges in this case rejected a likelihood approach based on probabilities in favour of a broader concept of dangerousness. This approach suggests that some courts, intuitively at least, are prepared to embrace a notion of risk that moves beyond likelihood based on probabilities or possibilities. A broader contextual approach to risk raises the question of whether, in relation to the precautionary principle, the standard of proof should be expressly applied to the individual components of risk (namely, likelihood and consequences) rather than the risk overall. To offer an example in a precautionary context, where there is uncertainty about whether ‘environmental damage’ (the consequence) is in fact ‘serious or irreversible’, the tribunal in determining risk must consider the evidence individually related to both consequences and likelihood. This discussion has implications not only for the precautionary principle, but also how statutes that incorporate concepts of risk (however expressed) should be interpreted and applied (see section 6). In summary, while there is no real agreement on what the standard of proof for precaution should be, the high degree of interest in defining a

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standard suggests that there is a common recognition of its central importance to precautionary administration. Although our focus in this chapter is on burden and standard of proof, if these concepts are applied to precaution, a number of related evidential concepts, especially relating to the admissibility and testing of expert evidence, are also ripe for consideration in relation to precautionary administration. In an adversarial setting, the courts are experienced at the task of testing the reliability or certainty of expert testimony. When an expert giving scientific testimony in the courtroom provides an opinion or evidence (or a prediction, or estimate), there is normally a process of close examination and testing of the reliability of that evidence through cross-examination and ensuring that the witness qualifies as an expert (section 79 of the Evidence Act 1995 (Cth) and see Velevski v. The Queen (2002) 187 ALR 233). If one moves from the arena of the courts to bureaucracy, how does the administration perform essentially the same task, of assessing the scientific evidence of prospective environmental damage? The same issue, namely the quality of agency data, is currently receiving attention in the United States (Wagner 2003). In Australia, such evaluations (perhaps equivalent to cross-examinations) of the evidence, occur behind the closed doors of policy makers and administrators, and there is limited empirical data available on this process. Where the administration seeks to be informed on matters of environmental (and indeed other) policy or administration, certain evidence is, no doubt, being accepted or rejected for its reliability and certainty. Assessment of the ‘evidence’ for predicted environmental harm is, and will remain, at least to some degree, at the heart of environmental administration. Precautionary discourse squarely raises issues of proof and causes us here to re-examine the applicability of legal rules of evidence to administration. We merely wish to raise the question: ought other evidential concepts, in addition to burden of proof and standard of proof, also form part of precautionary administrative decision making? We also consider that there are potentially many lessons on scientific and technical fact finding for administrative agencies from the long history of consideration of issues of scientific proof and scientific uncertainty within the adversarial context (for example, Freeman and Reece 1998 and Jasanoff 1997). As is the case in the courts, the objective of absolute certainty or full proof is as much an unattainable goal in the administrative context. Confronted with uncertain facts, constrained time frames, limited resources and the ongoing controversy over the ‘objectivity’ of science, what indeed is the evidential task for an administrative decision maker? These constraints on fact-finding processes in the courtroom are not confined to the environmental context. Not all relevant evidence is necessarily admissible in court (Evidence Act 1995 (Cth)) because parties and


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the courts do not have infinite resources to engage in fact finding. The quality of the evidence admitted to court proceedings relates more generally to the fairness of legal processes. Even in the criminal law context, the High Court has held that the common law does not impose on trial judges a duty to achieve ‘perfect justice’, but rather an obligation to ensure a fair trial is about making the proceedings as fair as the courts can make it (see Bronitt and McSherry 2005, pp 101ff, citing Brennan J in Jago v. District Court (NSW) (1989) 168 CLR 23 at 49).

3. THE ABSENCE OF PRECAUTIONARY EVIDENTIAL CONCEPTS IN LAW MAKING In Australia, policy makers and parliaments are not exposed to judicial review of the factual basis for policy or the making of legislation. Although accountability does exist in the form of political and moral accountability and also certain constitutional limitations (and scrutiny of legislation and subordinate rules occurs through parliamentary and Senate Committee procedures), there is no searching review of the factual basis of legislative rules. Australian policy makers and parliaments are thus not generally subject to any particular ‘burden’ or indeed ‘standard’ of proof before legislation is adopted. There is no legal requirement for an evidence-based approach to law making or legislative reform. However, it should be noted that while this is the case for legislative rules, the making and validity of subordinate laws (rules or regulations) are judicially reviewable on a number of grounds for legal validity (Creyke and McMillan 2005, pp. 272–274, 298, 399–400). These grounds of judicial review (unreasonableness, uncertainty, unauthorized purpose, that the subordinate law is of disproportionate effect, or impermissibly wide or narrow (Creyke and McMillan 2005, Ch 7–9, 12, 14)) are capable of being based on factual matters but their consideration is beyond the scope of this chapter. Since the 1970s, environmental regulatory regimes, governing environmental impact assessment and risk assessment, have operated by a process of identification of substances or activities that are known to be or suspected of being harmful to the environment. Such regimes may prohibit and regulate substances or activities, either when their capacity to cause environmental damage is known (so-called preventative regulation) or when their capacity to cause environmental damage is not known but nonetheless as a matter of policy it has been decided to prohibit or regulate them (so-called precautionary regulation). Since Australian parliaments, in law making, are not bound by evidential considerations, it is difficult, if not impossible, to categorize Australian environmental policy and law as either

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preventative or precautionary. This highlights a fundamental problem for the implementation of the evidential components of precautionary policy and law making in democratic law making systems.

4. THE EXPRESS AND IMPLIED RECOGNITION OF PRECAUTIONARY EVIDENTIAL CONCEPTS WITHIN STATUTES AND ADMINISTRATIVE DECISION MAKING The second context in which evidential issues concepts within precaution might arise is administrative decision making. Once legislation is passed, a statute can create precautionary obligations and burdens in one of two ways. It can contain an express obligation by the incorporation of precaution into the text, of which there are many examples in Australian environmental law. Alternatively, there may be no express precautionary obligation but the regulatory regime may, in substance, create a burden or obligation that in effect operates in a precautionary manner – an implied principle of precaution. Indeed, the techniques of regulating precaution are not mutually exclusive, since a regulatory regime may incorporate both an express formulation of precaution and also substantively include provisions that in effect operate in a precautionary manner (see, for example, the Environment Protection and Biodiversity Conservation Act 1999 (Cth) and the Gene Technology Act 2000 (Cth)). An analysis of common forms of environmental regimes (such as environmental impact assessment) that operate by restricting certain activities or substances reveals that, irrespective of express inclusion of precautionary text or burden of proof, these statutes impose an obligation akin to a burden of proof on applicants and agencies. These regimes operate by creating a presumption of environmental damage from defined categories of activities or substances, and regulating or prohibiting their use in some way. Such environmental regulations are usually designed so that lists of activities or substances fall into one of three generically described categories (prohibited, permitted upon obtaining further approval, permitted). This form of regulatory design underpins many forms of environmental regulation such as planning and environmental/risk assessment regimes. Within the category of ‘permitted upon obtaining further approval’, the burden to demonstrate that the activity or substance is safe is located on applicants or agencies by regulatory design (Cameron 1999). A classic and already well-recognized example is chemical risk assessment (Pearse and Wright 1999). The statutory creation of health and safety regulatory burdens on industry is also well recognized in the United States. The case which


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industry must make to conduct a prohibited activity is referred to as ‘rebutting a presumption of protection’ (Wagner 2003). So, while parliaments themselves may not be bound by an ‘evidencebased’ approach to enacting laws, they can and have attached precautionary obligations to the regimes they enact. In terms of the language of burden and standard of proof, the question that remains unanswered by the legislators is this: to what extent is the administration bound by evidential principles in performing its precautionary administrative functions? Here there is, at least superficially, a mismatch between the precautionary discourse on burden of proof and standard of proof and the text of Australian legislative regimes, which do not specifically address evidential issues in terms of the burden of proof and the standard of proof. Of course the regulatory regimes can and do provide broad, and in some cases (especially in risk assessment regimes) extremely detailed, obligations and standards that applicants for approval and in some instances decision makers must meet. Importantly, those regulatory obligations are more commonly expressed in terms of the subject matter of scientific information or evidence that must be presented to the decision maker rather than specifically defining the qualities or standards of the information that underpins decision making. In the absence of regulatory provisions that prescribe the quality of information, or standard of proof, compliance with the regulation by simply submitting information on the prescribed subject matter of any (indeed no particular) quality can become just a matter of a mere formality for satisfying administrative process. The relative open-endedness of fact-finding obligations in environmental and risk regulation, particularly in precautionary regulatory settings, leads to a broader set of issues relating to precautionary regulatory design. These include issues such as: catering for the inherent limitations of scientific information; the extent to which administrative decision-making processes can and do rely on scientific information in balance with other considerations; and, whether and to what extent it is appropriate that administration mimic evidential approaches in adjudication. Of course, these issues are familiar in administrative legal discourse. However, it seems to us that they take on a larger significance in the context of environmental regulation and precaution – a principle that purports to deal in environmental administrative decision making, scientific uncertainty, and indeed, according to many (but not all) commentators, also burden of proof and standard of proof. Similarly, we note that, on the one hand, administrative law deals in the language of ‘obligations’ on decision makers and of decision makers being satisfied of factual matters, whereas evidence law deals in the language of burdens and standards of proof. Both doctrines seem relevant to this chapter. Although the terminology used within each area of doctrinal law

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is different, they are in essence raising the same set of problems, namely directing decision makers who are facing uncertainty. While precautionary environmental regulation in Australia does not expressly address issues of proof and evidence in environmental fact finding and decision making, and the academic community continues to debate their relative importance to precaution, Australian administrative decision makers are not entirely without some more general (but limited) guiding doctrinal influences about fact determination in administration. These principles of administrative fact finding are derived not only from administrative law (both judicial and merit review) but also from the principles of statutory construction as considered in the next section.

5. THE LIMITS TO DERIVING PRINCIPLES FOR FACT FINDING IN PRECAUTIONARY ADMINISTRATION FROM JUDICIAL REVIEW AND MERIT REVIEW PROCEEDINGS The potential for judicial review proceedings to develop principles of fact finding for precaution can be dealt with relatively briefly here. In Australian administrative law, the principles of judicial review of findings of fact are limited to legal errors while determining the facts, subject only to an applicant for review being able to argue successfully that there was ‘literally no evidence’ to support fact finding, or that the reasoning process was ‘very seriously irrational or illogical’ (Aronson, Dyer and Groves 2004) or that the fact was jurisdictional (Timbarra Protection Coalition Inc v. Ross Mining NL (1999) 46 NSWLR 55; Corporation of the City of Enfield v. Development Assessment Commission and Another (2000) 199 CLR 135; see further Creyke and McMillan 2005, pp. 329–333). While judicial review can raise the problematic fact/law distinction (Aronson, Dyer and Groves 2004 and Creyke and McMillan 2005) and the justiciability of elements of precaution (Fisher 2001), these issues are beyond the scope of this chapter, except to note that there are ongoing tensions and developments in this sphere (see further Australian Pork Limited v. Director of Plant and Animal Quarantine (2005) FCA 571 (27 May 2005)). The courts have, subject to limited exceptions such as having ‘no evidence’ on which to base a decision, not prescribed the quantum or quality of evidence that is needed by administrative decision makers. Nonetheless, commentators on administrative law debate the existence of a potentially elastic probative evidence rule (Creyke and McMillan 2005), a debate which is relevant to administrative tribunals and also to judicial review. Creyke and McMillan (2005) note:


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The debate starts from the settled principle that there must be some evidence to support a decision; hence under the ‘no evidence’ principle, a decision will be invalid if there is ‘no evidence’ to support it . . . But what kind of evidence? The adjective ‘probative’ is superficially appealing, because it means ‘affording proof’. Thus a decision must be supported by evidence that ‘affords proof’ for the decision. In a legal context, however, notions of ‘evidence’ and ‘proof’ can soon develop into a more demanding obligation for process of reasoning that ‘rationally’, ‘logically’ or even ‘defensibly’ supports – or proves – the decision that has been made. (p. 675)

While doctrines of judicial deference limit the potential of judicial review as a source of rules to guide administrative decision makers on fact finding for the purposes of implementation of precaution, more detailed consideration of merit review is justified for two reasons. First, merit review proceedings in Australia on precaution are the source of specific decisions on precautionary burden of proof and standard of proof. Secondly, although not technically bound by the evidential principles adopted in merit review proceedings, administrative decision makers within Australian government agencies are potentially guided by the general principles that govern finding facts in merit review of administrative decisions. The general rule, established by the various statutes establishing merit review forums, is that the rules of evidence do not apply to merit review proceedings, a term that, in Australia, has historically referred to review by the executive arm of government of its administration (see Creyke and McMillan 2005, Ch 3). The rules, or indeed perhaps more accurately, the extensive freedoms governing the finding of facts during merit review are well established by extensive case law and statute (Creyke and McMillan 2005). However, while not being bound by the rules of evidence, merit review may be informed or guided by the rules of evidence in such manner as appropriate. So, while potentially undertaking an administrative review function, in a merit review forum the actors can selectively adopt rules or principles drawn from traditional adversarial settings. This ‘voluntary’ but authorized adoption of the rules of evidence in a merit review forum signals a blurring of the traditional boundaries between administrative decision making and the rules of evidence. If merit review is to be informed or guided by the rules of evidence, the next question is the extent to which it is appropriate to reach back into the process of administration and consider the extent to which the rules of evidence ought to apply to the original administrative decisions. While acknowledging the ‘meagre’ case law and statements of principle on this issue, Creyke and McMillan (2005) consider that there is an unstated assumption that administrative decision makers, subject to complying with the criteria for lawful decision making, have considerable freedom as to the

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nature and sources of information that they may consult in making decisions – although their reliance on the information may be regulated. But this raises an important question. As they note, the ‘substantial body of case law as to how administrative tribunals should go about the task of fact finding’ is ‘generally applicable to administrative decision making’ (2005, 672–676 at p. 673). If merit review bodies are to be informed or guided by the rules of evidence, ought not the administration, particularly where potentially subject to merit review, also be informed or guided by the same rules of evidence? Similarly, in a criminal investigation should investigators be constrained to consider only admissible evidence in their investigation? Indeed, should they work with a presumption of innocence? In the current system, they patently do not. In the administrative domain, this sits within the context of overriding policy concerns as to whether, first, the standard of fact finding by a merit review body ought to be more or less rigorous than the original decision maker, and, secondly, whether the definition of such ‘tribunal’ standards of fact finding would ‘re-introduce the rules of evidence by the back door’ (Creyke and McMillan 2005, p. 166). A final policy concern arises as to the suitability of science-based environmental decisions for merit review (Administrative Review Council, 1994). The voluntary but authorized adoption of the rules of evidence within merit review forums does extend to burden of proof and standard of proof in appeals involving precautionary regulation (Creyke and McMillan 2005, pp. 166 and 673). For example, in relation to burden of proof there is no formal onus universally placed on an applicant in the Administrative Appeals Tribunal (a common forum for federal precautionary disputes). However, as a practical matter the applicant, in order to be persuasive, might need to establish the existence of a particular fact (Pearce 2003, McDonald v. Director-General of Social Security (1984) 1 FCR 354). Rather than apply an evidential standard of proof, it is said that it is the tribunal’s responsibility to be ‘reasonably satisfied’ on each component issue (Creyke and McMillan 2005, p. 673). In relation to burden of proof, this is confirmed by a recent Australian merit review decision in which precaution was applied (Conservation Council of SA Inc v. Development Assessment Commission & Tuna Boat Owners Association (1999) SAERDC 86 (unreported, Judge Trenorden and Commissioners Hodgson and Berriman, 16 December 1999)). This decision acknowledges that the applicant/proponent and an agency (and indeed the court considering an appeal) are all concerned to determine the same facts. On appeal the Court said (at para 24): It is our task, as it was that of the relevant authority, to assess the proposed development against the relevant provisions of the Development Plan. The


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development should be ecologically sustainable in the terms of Objective 35 and Principle of Development Control 12. The onus lies on the proponent to show that the development would meet the policy set out in the Development Plan.

On further appeal, the Court of Appeal of South Australia, per Chief Justice Doyle, agreed with this conclusion, but did add that it depended on the circumstances of the case. In other words, it would depend upon the statute. The Court, when administratively reviewing the decision of the relevant authority, was required to be satisfied that the development would meet environmental policy objectives, as indeed was the task of the relevant authority when making the original decision. The proponent, at least in merit review, had the onus to demonstrate that the proposed development would meet environmental objectives as set out in the statute. The general principles for determining standard of proof in precautionary merit review forums are similar. Once again, the tribunals are not bound by the rules of evidence adopted in civil litigation, yet appellants in specialist courts and tribunals would ordinarily be required to satisfy factual issues based on the civil standard of proof, on the balance of probabilities or the Briginshaw standard (Creyke and McMillan 2005, pp. 174, 673). There is a spectrum of possible standards that could be applied in the administrative context, ranging from the probative evidence rule (Creyke and McMillan 2005, p. 672), the modified civil standard of Briginshaw (Hunter, Cameron and Henning 2005), through to the more specific and onerous statutory standard of reasonable hypothesis (for example, that contained within the Veteran’s Entitlements Act 1986 (Cth), s 120). Despite academic commentary encouraging a modified standard of proof in response to precaution (noted earlier in this chapter), it appears that precaution does not modify the usual civil burden of proof adopted in merit review proceedings. In Tuna Boat Owners, on an appeal to the South Australian Environment Resources and Development Court it was stated that the respondent (proponent) would have to discharge its burden of proof only when the (objector) appellant: ‘has proved, on the balance of probabilities, that there is a threat of serious or irreversible damage to the environment’. Similarly, in De Brett Investments Pty Ltd and Anor and Australian Fisheries Management Authority, Re (2004) 82 ALD 163, the Administrative Appeals Tribunal (AAT) stated that: ‘[t]he precautionary principle is still regarded as requiring that caution be exercised but only in situations in which it is established, on the balance of probabilities, that serious or irreversible environmental damage can reasonably be expected if a certain course of action is taken’ (at 207). A specialist court or tribunal conducting a merit review would be concerned with whether or not a decision maker had properly considered ‘lack

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of full scientific uncertainty’ as to ‘threats’ or ‘serious or irreversible damage’. Consistent with this, in De Brett the Administrative Appeals Tribunal was concerned to define and interpret the core elements of precaution such as ‘threat’ and ‘full scientific certainty’ for the purposes of applying precaution. Furthermore, in De Brett, the Tribunal stated: [W]here there is a threat of serious or irreversible environmental damage, there is some aspect that gives an indication that there will be serious or irreversible damages if a certain course is followed. That aspect needs to be established on the balance of probabilities for, in the absence of any contrary indication in the Act, it is the civil standard of proof that is adopted . . . Just as the civil standard is not a fixed standard in all cases but adapts according to the seriousness of the issue under consideration in accordance with the principles in Briginshaw v. Briginshaw so too does the standard of proof where the precautionary principle is concerned. (at 208)

As we have previously argued (Jones and Bronitt, 2003) the Briginshaw standard of proof is useful in the context of implementing precaution because, like the precautionary principle, the Briginshaw standard is mindful of the seriousness of consequences and has inherent flexibility to respond to this issue. However, as noted earlier, in Australia the statements of precautionary burden of proof and standard of proof made in merit review forums only provide a guide to administrative decision makers. Although theoretically influential, the extent to which administrative decision makers exercising administrative functions have been or are inclined to be guided by such approaches to fact finding in decision making remains empirically unknown. In any event, this ad hoc and uncertain development of these principles through adjudicatory forums is potentially less than desirable, a theme that we will return to later in this chapter.

6. DERIVING PRINCIPLES FOR FACT FINDING IN PRECAUTIONARY ADMINISTRATION FROM STATUTORY CONSTRUCTION The final context in which approaches to fact finding by administration is explored is the process of construing and applying a statute. Creyke and McMillan also note that the process of fact determination during proceedings can ‘merge with the process of construing and applying a statutory provision; some provisions define the standard of satisfaction required in applying the provision (for example, “reasonable hypothesis”, “real chance”)’ (2005, p. 673). This issue is particularly relevant to environmental regulation where the triggering of key decision-making processes such


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as environmental impact assessment can be defined in terms of a ‘likely’ impact on the environment (Farrier, Whelan and Brown 2002, at 441–442). In Pacific Century Production Pty Ltd v. Watson [2001] FCA 1139 (Unreported, Kiefel J, 17 August 2001; decision affirmed on appeal in Pacific Century Production Pty v. Watson (2001) 113 FCR 466) the Federal Court considered whether farm goods were ‘likely’ to be infected with diseases subject to quarantine under s 35 of the Quarantine Act 1908 (Cth). At issue was whether the ‘decision was based on an opinion as to a fact namely, that the goods . . . were likely to be infected’ (at para 15). Her Honour (at paras 23–28) cited the High Court of Australia decision of Boughey v. The Queen (1986) 161 CLR 10, which discussed the meaning of ‘likely to cause death’ in the context of murder in the Criminal Code (Tas). Her Honour held that ‘likely’ will be ‘affected by its statutory context’. In this case, she held that its ordinary meaning has been ‘taken to be a ‘real and not remote’ chance regardless of whether it is less or more than 50 per cent’ (at para 24) citing Boughey v. The Queen (1986) 161 CLR 10 at 21 per Mason, Wilson and Deane JJ. Furthermore, Justice Keifel (also at para 24) noted that: ‘Gibbs, CJ in Sheen v. Fields Pty Ltd (1984) 58 ALJR 93, 95 endorsed the description of a “likelihood” as “something less than probability but more than a remote possibility” ’. Her Honour then considered the necessary ‘level of satisfaction’ required before a quarantine officer could impose quarantine orders on an Australian grape farm. When deciding the ‘necessary level of satisfaction about the prospect of infection’, her Honour took into account the possible harmful consequences (‘degree of harm’) of the spread of diseases brought into the country. She stated: The prevention or control of diseases would, it seems to me, be rendered difficult and in some cases not possible if a quarantine officer in every case needed evidence to support a probability of the existence of disease in imported plants or goods. No basis for such a level of satisfaction can be found in the Act and its objects. ‘Likely’ in my view is here to be understood in its ordinary sense. (at 26)

Significantly, her Honour then referred to interpretations of ‘likely’ by the Land and Environment Court in decisions arising from an ‘analogous context’, namely environmental legislation, before concluding: It is of course obvious that quarantine orders may be productive of great harm to individuals and businesses. The prospect of the existence of the disease must therefore be real and not only a remote possibility. To require more however, would seem to me to put the individual above the stated wider objects of protection from disease which may affect many persons and enterprises, and perhaps the environment itself. (at 27)

Her Honour concluded that the risk of infection from disease was ‘real and not remote’. In this way, Justice Keifel adopted the ordinary meaning

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approach to the interpretation of the term ‘likely’. Her Honour’s approach of combining an ordinary meaning approach with a de minimis test leaves considerable discretion to the decision maker. In the criminal law context, foresight of the likelihood of a proscribed consequence (which is termed ‘recklessness’) has generated multiple interpretations depending on the offence. Thus for murder, under the common law, the likely consequence of the accused’s actions (that is death) must be foreseen as a probability, whereas for other, less serious offences, a lower threshold based on possibility has been adopted (Bronitt and McSherry 2005). The difficulty with Justice Keifel’s approach of drawing on Boughey’s rather imprecise definition of ‘likely’ is that the context in which risk determination by a public servant occurs is very different from murder, where an ordinary person who causes death recklessly commonly does so on ‘the spur of the moment’ – hence the reluctance of the High Court and others in the criminal law to refine the definition of ‘likely’ in terms of statistical probabilities or percentages. In our view, Boughey is not an appropriate precedent to apply to the environmental law context. Rather than leaving it to the courts to develop in an ad hoc fashion, what is needed here is legislation to stipulate broadly the range of factors professional decision makers should adhere to in exercising discretion – this guidance may be context-specific, varying according to the regulatory domain, as well as establishing some general expectations and principles governing the approach to decision making when dealing with scientific uncertainty. The significance of the Pacific Century decision is that in this judicial decision a number of themes converge. Although there is no express precautionary obligation in the Quarantine Act 1908 (Cth), the Act is of the type that may be characterized not only as based on risk analysis, but also as precautionary. Justice Keifel’s legal construction of the statute draws not only on environmental law but also criminal law. In the course of the judgement the legal analysis considers aspects of both administrative law (‘level of satisfaction’ of the decision maker) and evidence law (consideration of probabilistic notions).

7.

CONCLUSIONS

This discussion of burden of proof and standard of proof within precaution reminds us that essentially the same problem confronts both administrative decision makers and adjudicators: the determination of facts and dealing with uncertainty when applying legal principles. Where scientific evidence forms part of the relevant facts for fact finding, in both administrative and courtroom contexts, the issues surrounding evidence and proof become oriented around the qualities of the facts and the fact-finding process.


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We can make two conclusions about the burden of proof and the standard of proof as emerging tools within a framework for fact finding in precautionary decisions in Australia. First, we have observed that where there is merit review of an express statutory obligation to implement a precautionary approach, adjudicators have voluntarily adopted the rules of evidence, including the ordinary rules relating to burden and standard of proof in civil matters (albeit on the Briginshaw standard) to guide the determination of relevant factual matters. The extent to which this approach in merit review can justify a ‘back-door’ entry of the rules of evidence into administration remains an important tension within administrative law. However, it is not only a theoretical issue – since further guidance from the courts would be desirable for administrative decision makers with current statutory obligations to implement precaution. Secondly, where there is an implied statutory obligation to implement a non-express but nonetheless precautionary approach (such as in the Quarantine Act 1908), in the course of statutory construction, we observe that the courts can merge the process of fact finding with the task of statutory construction. Furthermore, the court’s reasoning on fact finding traverses not only concepts of administrative law (‘level of satisfaction’) but also notions of proof and probability drawn from evidence law. On the one hand, this is unsurprising, since the statutory construction proceedings are adversarial and subject to the usual rules of evidence. However, it does betray a convergence between the two areas of law dealing with fact finding within adjudication on precaution. Also, since the statutory construction of ‘likely’ in Pacific Century has, of itself, broader applicability as a precedent for interpretation of the meaning of ‘likely’ or conceptions of the likelihood of harms within other environmental or precautionary statutes, the reasoning has the potential to have a far-reaching effect. These conclusions are perhaps of limited significance when considered alongside the broader implications of this exploration. Amongst these implications we include: first, the recurrent theme of tensions between the separation of administrative law and evidence law and the potential to characterize the issues relevant to fact finding in terms of either area (or some hybrid). Secondly, and related to the first point, we raise the issue of whether there needs to be greater clarity on the conceptualization of fact finding within precaution, namely, whether fact finding in the context of precaution aims to meet some standard of proof (with its inherent limitations), or indeed, whether it is more about the various parties simply conforming with procedural requirements to furnish evidence without imposing further obligations either as to the quantum or quality of evidence. Thirdly, we observe significant convergence between the elements of proof within precaution and some of the traditional core principles of criminal law (and uncertainties about them).

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Finally, perhaps the most important point is that neither the academic commentary nor the adjudicators really address the questions about the adequacy of the science before administrative decision makers, and whether they have enough evidence (scientific or otherwise) to support a decision that is potentially at the core of the precautionary principle. For example, would one study demonstrating that there will be no serious or irreversible environmental damage satisfy fact-finding requirements? Must there be corroboration? What if there were more than one study and there were competing interpretations of the data? What rigour is required of the acceptable studies? At present the law does not guide decision makers, yet these are the realities of utilizing scientific data for the prediction of environmental effects. In further developing precautionary standards of proof, regulators and the courts need to be mindful of not only the realities of decision making under conditions of scientific uncertainty but also the difficulties that the Australian (and other) courts have had attempting to resolve these issues in an adversarial context (see further Seltsam Pty Ltd v. McGuiness; James Hardie & Coy Pty Ltd v. McGuiness (2000) 49 NSWLR 262). This, in itself, reinforces the argument that the obligation to fact find in environmental statutes, to the extent that it ought to be defined, is best determined by statutory provisions rather than being developed by the courts in an ad hoc and piecemeal fashion. Our ultimate conclusion therefore is that, in terms of environmental regulatory design, only small steps have been taken towards creating a coherent framework for fact finding and resolving issues of proof within both environmental risk regulation and precaution. The spontaneous adoption of the burden of proof and standard of proof within the precautionary literature, and in the course of fact finding as part of administrative review and statute construction in Australia, suggests that the legal community is resorting to familiar concepts to fill a regulatory void. Rather than developing an overarching general principle of proof in environmental matters, we suggest that the design of a suitable regulatory architecture governing proof should be context-dependent. Evidential concepts, which are not themselves static, have the potential to evolve further with a view to strengthening the precautionary principle in a variety of legal and administrative contexts.

NOTE 1. The authors would like to acknowledge the very able research assistance of Katherine Bermingham and Prita Jobling and thank Robin Creyke and Fiona Wheeler for their comments on earlier versions of this chapter.


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REFERENCES Adelman, D.E. (2004), ‘Scientific activism and restraint: the interplay of statistics, judgment, and procedure in environmental law’, Notre Dame Law Review, 79, 497–583. Administrative Review Council (1994), Environmental Decisions and the Administrative Appeals Tribunal, Canberra: Australian Government Publishing Service. Australian Law Reform Commission (1985), Evidence, Report No. 28 (Interim), Canberra: Australian Government Publishing Service. Aronson, M., M. Dyer and M. Groves (2004), Judicial Review of Administrative Action, 3rd edn, Sydney: Law Book Company. Bates, G. (2002), Environmental Law in Australia, 5th edn, Sydney: Butterworths. Bronitt, S. and B. McSherry (2005), Principles of Criminal Law, 2nd edn, Sydney: Law Book Company. Cameron, J. (1999), ‘The precautionary principle: core meaning, constitutional framework and procedures for implementation’, in R. Harding and E. Fisher (eds), Perspectives on the Precautionary Principle, Sydney: Federation Press, pp. 29–58. Cameron, J. (2001), ‘The precautionary principle in international law’, in T. O’Riordan, J. Cameron and A. Jordan (eds), Reinterpreting the Precautionary Principle, London: Cameron May, pp. 113–42. Creyke, R. and J. McMillan (2005), Control of Government Action: Text, Cases and Commentary, Sydney: LexisNexis Butterworths. Farrier, D. (1999), ‘Factoring biodiversity conservation into decision-making processes: the role of the precautionary principle’, in R. Harding and E. Fisher (eds), Perspectives on the Precautionary Principle, Sydney: Federation Press, pp. 99–121. Farrier, D., R. Whelan and C. Brown (2002), ‘Addressing scientific uncertainty in local government decision-making processes’, Environment and Planning Law Journal, 19, 429–44. Fisher, E. (2001), ‘Is the precautionary principle justiciable?’, Journal of Environmental Law, 13, 317–34. Fisher, E. (2003), ‘Law, precaution and administration: the precautionary principle and Australian courts 1993–2003’, paper presented at The Precautionary Principle in Environmental Regulation: 10 Years Since Leatch, 20–21 November, Canberra: The Australian National University. Freeman, M. and H. Reece (eds) (1998), Science in Court, Aldershot: Ashgate. Gullett, W. (2000), ‘The precautionary principle in Australia: policy, law and potential precautionary EIAs’, Risk: Health, Safety and the Environment, 11, 93–124. Heydon, D. (2004), Cross on Evidence, 7th edn, Sydney: Butterworths. Hunter, J., C. Cameron and T. Henning (2005), Litigation II: Evidence and Criminal Procedure, 7th edn, Sydney: Butterworths. Intergovernmental Agreement on the Environment (IGAE) (1992), Heads of Government in Australia, May, available at http://www.deh.gov.au/esd/national/ igae/ accessed 10 November 2005. Jasanoff, S. (1997), Science at the Bar: Law, Science, and Technology in America, Cambridge, MA: Harvard University Press. Jones, J. and S. Bronitt (2003), ‘Standards and burdens of proof: recognising the

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divergent perspectives of science and law’, paper presented at The Precautionary Principle in Environmental Regulation: 10 Years Since Leatch, 20–21 November, Canberra: The Australian National University. Ligertwood, A. (2004) Australian Evidence, 4th edn, Sydney: Butterworths. Nagorcka, F. (2003), ‘Saying what you mean and meaning what you say: precaution, science and the importance of language’, Environment and Planning Law Journal, 20, 211–22. Pearce, D. (2003), Administrative Appeals Tribunal, Sydney: Butterworths. Pearse, W. and H. Wright (1999), ‘Chemical assessment and the precautionary principle’, in R. Harding and E. Fisher (eds), Perspectives on the Precautionary Principle, Sydney: Federation Press, pp. 240–53. Stein, P. (2000), ‘Are decision-makers too cautious with the precautionary principle?’, Environment and Planning Law Journal, 17, 3–23. Wagner, W. (2003), ‘The “bad science” fiction: reclaiming the debate over the role of science in public health and environmental regulation’, Law and Contemporary Problems, 66, 63–133. Whitehouse, J.F. (1999), ‘Will the precautionary principle affect environmental decision-making and impact assessment?’, in R. Harding and E. Fisher (eds), Perspectives on the Precautionary Principle, Sydney: Federation Press, pp. 59–82.

Cases Aldekerk Pty Ltd v. The City Council of Port Adelaide Enfield & EPA No. ERD-0061 (2000) SAERDC 47 (Unreported, Judge Bowering, 5 September 2000). Alumino (Aust) Pty Ltd v. Minister Administering the Environmental Planning and Assessment Act 1979 (1996) NSWLEC 100 (Unreported, Talbot J, 29 March 1996). Australian Pork Limited v. Director of Plant and Animal Quarantine (2005) FCA 571 (27 May 2005). Boughey v. The Queen (1986) 161 CLR 10. Briginshaw v. Briginshaw (1938) 60 CLR 336. Conservation Council of SA Inc v. Development Assessment Commission & Tuna Boat Owners Association (1999) SAERDC 86 (Unreported, Judge Trenorden and Commissioners Hodgson and Berriman, 16 December 1999). De Brett Investments Pty Ltd and Anor and Australian Fisheries Management Authority, Re (2004) 82 ALD 163. Corporation of the City of Enfield v. Development Assessment Commission and Another (2000) 199 CLR 135. Jago v. District Court (NSW) (1989) 168 CLR 23. McDonald v. Director-General of Social Security (1984) FCR 354. Nicholls v. Director-General of National Parks & Wildlife (1994) 84 LGERA 397. Leatch v. National Parks & Wildlife Service and Shoalhaven City Council (1993) 81 LGERA 270. Pacific Century Production Pty Ltd v. Watson [2001] FCA 1139 (Unreported, Kiefel J, 17 August 2001; decision affirmed on appeal in Pacific Century Production Pty Ltd v. Watson (2001) 113 FCR 466). R v. Favre [1999] 2 VR 537. Seltsam Pty Limited v. McGuiness; James Hardie & Coy Pty Ltd v. McGuiness (2000) 49 NSWLR 262.


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Sol Theo v. Caboolture Shire Council [2001] QPELR 101 (Unreported, McLaughlin QC DCJ, 14 September 2000). Timbarra Protection Coalition Inc v. Ross Mining NL (1999) 46 NSWLR 55. Velevski v. The Queen (2002) 187 ALR 233.

International Instruments United Nations General Assembly, Report of the United Nations Conference on Environment and Development (Rio de Janeiro, 3–14 June 1992), Annex I: Rio Declaration on Environment and Development, A/CONF.151/26 (Vol. I), 12 August 1992.

8. Tr(e)ading cautiously: precaution in WTO decision making Jan McDonald1 1.

INTRODUCTION

Of all the principles of sustainable development, the precautionary principle is at once the most alluring and elusive. It offers the reassurance of a ‘do no harm’ philosophy, but lacks the necessary clarity for direct implementation or application. ‘Precaution’ attempts to bridge the gap between the innovative powers of science and its capacity to anticipate and predict consequences (Harremoës et al. 2002, p. 209); in regulatory terms, it recognizes that prevention is better than cure. The concept of precaution in environmental and health decision making has emerged at a time when international economic activity is expanding in size and geographical scope, largely spurred by the very technological innovation that precaution responds to. The domination of economic developmentalist discourse in global politics means that precaution is constantly under pressure; criticized for being anti-progress. Nowhere are these tensions better demonstrated than within the principal vehicle for global economic integration, expansion and liberalization – the World Trade Organization (WTO). As part of this book exploring the implementation of the principle, this chapter examines precaution in the law and practice of the WTO. This chapter is organized into three sections. Section two briefly sketches the features of precautionary decision making that can then be used to examine WTO law and practice. Section three then considers whether these features are reflected in the decisions of dispute settlement panels and the WTO Appellate Body (AB) dealing with the General Agreement on Tariffs and Trade (GATT), the Agreement on Technical Barriers to Trade (TBTA) and the Agreement on Sanitary and Phytosanitary Measures (SPSA). Section three shows that the WTO’s ‘judicial’ decision makers generally strive to interpret these provisions in a way that preserves the precautionary autonomy of Members, but that the texts themselves are often skewed against such considerations. Section four then offers some observations 160

Precaution in WTO decision making

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about legislative and quasi-legislative decision making within the WTO, namely the process of negotiating and accepting new liberalization undertakings and the processes for developing international standards. I conclude in section five that there are limits to what the dispute settlement framework can do within the WTO’s normative framework of trade liberalization. Rather than ‘shutting the GATT once the horse has bolted’, the WTO needs to apply principles of precautionary decision making to the critical stage at which new undertakings are made.

2. FEATURES OF PRECAUTIONARY DECISION MAKING There is no definitive statement of ‘the’ precautionary principle, nor any agreement on when it applies or what it requires. Precaution is an overarching principle that will always require contextual elaboration. The discussion in this chapter is necessarily encumbered by this fluidity, but some general features of precautionary decision making can be identified. Although they are open to dispute, they are briefly outlined here as a useful set of factors for guiding an appraisal of WTO decision making. The first set of issues is the circumstances in which an obligation of precaution arises. Precaution is invoked in cases of ‘scientific uncertainty’; where some risk or potential for harm to human, animal or environmental safety is identified, but incapable of quantification. It is the inability to assess the level of risk that triggers precautionary obligations: risks whose relative likelihood can be expressed as probabilities demand preventive decision making, rather than precaution (Harremoës et al. 2002, p. 188). In practice, the line between quantifiable and unquantifiable risks is blurred, but the distinction between precautionary and preventive measures is relevant to the analysis in section three of this chapter. One of the corollaries of this distinction is that perceptions of risk and precaution differ from country to country, subject to subject. It is impossible to separate purely ‘scientific’ judgments from political and value choices. Stronger versions of precaution recognize that definitions of what is ‘at risk’ are based on subjective assumptions and values (Harremoës et al. 2002). Recognizing the rights of each country to adopt precautionary measures – referred to here as ‘precautionary autonomy’ – involves respecting legitimate differences of priority, and recognizing a wide variety of perspectives on risk and sources of information about source of risk. The numerous formulations of the precautionary approach highlight that there is no single threshold for triggering an obligation of precaution (Birnie and Boyle 2002, p. 123). It ranges from risks of ‘non-negligible’, ‘non-trivial’ or

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‘significant’, to ‘serious’ or ‘serious or irreversible’ harm (Cameron 1999, p. 242). Whatever the language, most agree that there should be a correlation between the level of threatened harm and the degree of probability required. Accordingly, the greater and less reversible the consequences, the smaller the permissible margin of error in predictions. Reponses to threats with less serious consequences will generally require stronger evidence of their likelihood. One of the most contentious aspects of the precautionary principle is whether it should shift the burden of justifying potentially damaging measures to the proponents of those measures. The analysis of WTO decision making below proceeds on the assumption that placing the burden of proving safety on the proponent will generally serve precautionary considerations more than locating it with those seeking to prevent harm, even though the standard of proof placed on the proponent is low. Conventional environmental impact assessment processes can provide a useful technique for operationalizing this burden. Good impact assessment techniques will ensure ongoing post-approval monitoring of impacts and auditing of the accuracy of predictions, in order to inform future decisions. Finally, there is disagreement about what action the precautionary principle requires. The strongest statements demand that potentially damaging activities should not proceed until potential adverse consequences are understood. Weaker ones simply fail to preclude preventive measures in the absence of scientific agreement about consequences. Economic feasibility or practicability also affects the content of precautionary decision making. Most statements refer either to cost effectiveness or cost-benefit analysis. The difficulty of any cost-benefit approach is the mismatch of costs and benefits: the costs of taking action are easily calculable and typically borne by government, while the costs of inaction (the benefits of precaution) are dispersed geographically, sometimes demographically, and often temporally or generationally. For this reason, a response that demands costeffective measures that can achieve agreed levels of protection is preferable to one resting on a cost-benefit analysis.

3.

PRECAUTION IN WTO ADJUDICATION

Using the broad characteristics of precaution outlined in section two, this part examines the role of precaution in the adjudication of disputes between WTO Members. It is beyond the scope of this chapter to rehearse the structure and operation of WTO agreements and the history of the trade-environment case law. Instead, this part focuses on the texts of the various WTO agreements relating to trade in goods, how their language has been applied by the WTO’s dispute resolution Panels and Appellate


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Body (AB) and how a more precautionary approach could be taken in future disputes. Issues of precaution do not arise in WTO dispute settlement because a Member is dissatisfied with the inadequacy of environmental measures that another Member has implemented. As a trade organization, WTO challenges arise when environmental or health measures are put in place that undermine the trade concessions afforded under the regime. A systemic or structural bias against precautionary measures therefore pervades the WTO’s dispute settlement regime. It arises when the decision to take action is challenged by those who argue that it should not be. This perverse operation of a precautionary approach operates as a shield, instead of a sword of proactive environmental policy making (Wirth 1994, p. 818). It highlights the delicate balance that tribunals must strike when resolving such disputes between legitimate domestic measures on the one hand, and trade obligations on the other. 3.1

Precaution in WTO Texts

The WTO consists of a suite of agreements that impose specific rules or ‘disciplines’ on the types of restrictions a Member may impose on the goods of its trading partners. The primary focus of the GATT is the elimination of tariffs and quantitative restrictions on trade and the imposition of obligations of non-discrimination (most favoured nation treatment) (GATT Article I) and non-protectionism (GATT Article III). The reduction in tariffs over time achieved under GATT was matched by a growth in nontariff barriers to trade, such as discriminatory product standards and testing requirements that were often contained in legislation dealing with public health or environmental protection. The WTO TBTA and SPSA were introduced to curb the abuse of such trade barriers by strictly regulating the way in which Members could introduce or maintain food safety and quarantine measures (SPSA) or other product standards or requirements (TBTA). Both agreements impose additional disciplines on WTO members to those contained in the GATT. These include the obligation to introduce measures to protect the public or the environment only when they are necessary, to base measures on international standards where possible, and to use the least trade-restrictive measure that can achieve the desired policy goal. The SPSA also introduces a strong requirement for scientific justification of food sanitary or plant and animal health requirements. The precautionary principle is not included as any sort of obligation – mandatory or hortatory – in these WTO agreements. The WTO Preamble refers to the overall objective of ‘sustainable development’, which it leaves undefined, but the principles of ecologically sustainable development (ESD) are not listed in any of the

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WTO texts. There are, however, several concessions to the precautionary autonomy of WTO Members throughout the texts. Importantly, the WTO Agreement preserves and recognizes the right of Members to adopt or maintain domestic measures aimed at achieving legitimate regulatory goals. In addition, the framework for disciplining trade in goods – the General Agreement on Tariffs and Trade (GATT) and the more detailed agreements relating to technical tariff barriers to trade and food and plant safety standards all recognize the right of Members to adopt measures for human, animal, plant or environmental protection. This regulatory autonomy is acknowledged differently in each of the agreements and this section outlines the operation and limitations of those provisions. As a trade agreement, the GATT does not explicitly apply to domestic environmental or public health laws as such. Its concern is domestic measures that restrict trade in goods in either a legally or factually discriminatory way. Restrictions or discrimination are generally prohibited but may be justified if it can be shown that they fulfil particular regulatory objectives and are not applied in a way that constitutes arbitrary or unjustifiable discrimination or a disguised trade barrier (GATT Article XX). Since this exception operates to permit otherwise inconsistent measures, the range of permissible regulatory objectives is limited. But it does include protection of human, animal or plant life or health (GATT Article XX(b)) and measures relating to the conservation of exhaustible natural resources (GATT Article XX(g)). Hence it expressly allows for measures with a precautionary rationale, albeit within the scope of a defence to breaching GATT disciplines. Members are free to set their own levels of health protection or conservation objectives, but Dispute Panels will ask whether a sufficient risk to health or conservation actually exists. Precautionary autonomy would be undermined were Panels to apply too high a threshold for sufficiency. So far this has not occurred, but as will be explained below, sufficiency is a relative concept and whether it serves to preclude the use of precautionary measures will be determined on a case-by-case basis. The right of Members to evaluate risk in quantitative or qualitative terms also supports precautionary choices at the local level (Asbestos AB, ¶167). The WTO’s General Agreement on Trade in Services (GATS) – the framework agreement for the liberalization of international trade in services – also explicitly recognizes Members’ rights to regulate service provision (GATS Preamble). The potential scope of the GATS is broader than the agreements dealing with trade in goods because of the wide definition of ‘services’. It is currently far more limited, however, because it is a ‘bottom-up’ agreement – the only general obligations are transparency (GATS Article II) and most-favoured-nation treatment (GATS Articles


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III). Like the GATT, GATS provides an exception for measures that are necessary to protect human, animal or plant life or health (GATS Article XIV(b)), but has no equivalent to the GATT’s exception for conservation of exhaustible natural resources. The implications of this omission are yet to be fully understood. The GATT’s restrictions on domestic regulation in areas of environmental protection are elaborated in the Agreement on Technical Barriers to Trade (TBTA). The right to introduce environmental or safety measures is an underlying premise of the TBTA, rather than an exception to nondiscrimination obligations (TBTA Preamble and Article 2.2). The choice of policy objectives and levels of protection is also safeguarded and in general terms, the TBTA leaves it to individual Members to determine which policy objectives they will pursue (TBTA Preamble and Article 2.2), and expressly recognizes the legitimacy of the objectives of human health or safety, animal or plant life or health, or environmental protection measures (TBTA Article 2.2). Theoretically, therefore, the starting point for TBTA disputes should be an acceptance that Members may adopt precautionary measures. But the TBTA balances Members’ rights to take such measures against the specific measure they select to achieve those objectives. These ‘balancing’ disciplines on the development and application of technical regulations include: ●

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the obligation to base domestic regulations on relevant international standards (where they exist), unless they would be ineffective or inappropriate to achieve the nominated policy goal (TBTA Article 2.4); and general criteria for all technical regulations, such as necessity, least trade-restrictiveness, non-discrimination and balancing or proportionality (TBTA Article 2.4).

As will be demonstrated below, their cumulative operation may compromise the use of precaution in national standard setting, despite the TBTA’s saving for domestic priorities. A key site for precautionary measures within the WTO has been the Agreement on Application of Sanitary and Phytosanitary Measures (SPSA), which disciplines the development and application of national measures for food safety and plant and animal health. The SPS framework is similar to the disciplines of the TBTA insofar as it permits Members to set their own levels of food safety and plant and animal protection (SPSA Preamble and Article 2.1), and disciplines the means by which those standards are achieved (SPSA Articles 2, 4 and 5). Like the TBTA, it raises a presumption of consistency for measures based on international standards,

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and imposes obligations of necessity, consistency and non-discrimination in the choice of SPS measure (SPSA Articles 2 and 5). The SPSA receives heightened attention primarily because the subject matter of the agreement relates solely to human or environmental risk, issues which are commonly the objects of precautionary decision making. Moreover, while the SPSA expressly reaffirms Members’ rights to introduce measures to achieve nationally-determined levels of health protection (SPSA Article 2.1), it adopts scientific evidence as the principal basis for justifying trade-restrictive measures (SPSA Article 2.2). This requirement of scientific evidence of risk immediately creates a tension with the precautionary principle, which is invoked precisely in the absence or insufficiency of science. In summary, therefore, Members are theoretically free to pursue extremely high standards of environmental or health protection, even where it is very expensive, provided they satisfy the other disciplines of the relevant Agreement (Atik 1997, p. 744). These disciplines include the use of international standards, necessity and least trade restrictiveness. The extent to which their application impinges upon Members’ precautionary autonomy is considered below. 3.2

The WTO AB’s Treatment of Precaution

The WTO AB has had little to say about the role of the precautionary principle in interpreting the WTO-consistency of trade-restrictive health or environmental measures. In its first consideration of the SPSA, the AB considered it unnecessary and ‘probably imprudent’ for it to take a position on the status of the precautionary principle in public international law (ECHormones AB, ¶123). It noted, however, that the SPS Agreement itself made no provision for the application of the precautionary principle to justify SPS measures, other than under SPSA Article 5.7 in respect of provisional measures. It also found that ‘responsible, representative governments commonly act from perspectives of prudence and precaution where risks of irreversible . . . damage to human health are concerned’ (ECHormones AB, ¶124). Apart from these observations, however, the AB concluded that the specific wording of SPSA prevailed over the precautionary principle. It has not revisited its views about the status of the precautionary principle; neither rejecting nor accepting its use as a guiding principle in WTO interpretation. For the most part, therefore, our understanding of the status of precaution in WTO law is gleaned from an evaluation of how the AB has approached the interpretation and application of WTO provisions. This evaluation is set out in the remainder of this section.


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International Standards and Precaution

While permitting Members to select their own levels of health protection, the TBTA and SPSA both encourage Members to base their technical regulations and SPS measures on relevant international standards (SPSA Article 3.1; TBTA Article 2.2). Harmonization is not a binding obligation nor even a ‘general rule’, since both agreements establish criteria by which higher standards may be justified (SPSA Article 3.3; TBTA Article 2.2; EC-Hormones AB, ¶163; EC-Sardines AB, ¶242), but the EC-Hormones and EC-Sardines disputes suggest that the presumptive influence of international standards is strong. The harmonization obligation is problematic for precaution in two ways. Firstly it dilutes or undermines the possibility of differences in perceptions of or responses to risk. This concern is offset by the provision of alternatives in each agreement. Secondly, the emphasis on international norms assumes that standard-setting bodies apply precautionary considerations in developing and drafting standards. That this does not occur is argued in section 4 of this chapter. 3.4

The Necessity and Balancing Requirements

Common to all the agreements on trade in goods and services is the stipulation that domestic regulations may only restrict trade to the extent necessary to achieve the policy objective and that they avoid unnecessary obstacles to trade (GATT Article XX; TBTA Article 2.2; SPSA Article 2.2).2 The necessity requirements create concerns about what leeway they give governments to introduce measures before a problem arises. The GATT Article XX necessity test has dominated commentary on the tradeenvironment interface. For years, the requirement of necessity undermined precautionary autonomy because it was subject to a narrow interpretation that required exhaustion of less trade-restrictive measures before the challenged measure could be justified (Thai-Cigarettes Panel, ¶75; TunaDolphin 1, ¶¶5.26–27, 5.31 (unadopted); Tuna-Dolphin II, ¶¶5.28, 5.39 (unadopted). In its revised approach to GATT Article XX, the AB has emphasized that paragraph (b) only requires exhaustion of reasonable alternatives (Korea-Beef AB, ¶162). In determining whether another measure is reasonably available, it is necessary to weigh and balance the importance of the health objective, the extent to which alternative measures contribute to the realization of the health objective being pursued, and its impact on trade (Korea-Beef AB, ¶¶162, 163, 166). The identification of reasonable alternatives should be undertaken in the light of economic and administrative

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realities, which may vary depending on how well-resourced or trained the bureaucracy may be (Asbestos Panel, ¶8.207). The Asbestos dispute between Canada and France illustrates the effect of the revised test. Canada argued that controlling the use of asbestos was a less restrictive option than France’s outright ban. Controls would indeed have impeded trade less than a ban, but the difficulties of controlling use made them an ineffective and unreasonable alternative to a ban (Asbestos Panel, ¶¶8.209, 8.217). The AB was therefore satisfied that it was unreasonable to require France to introduce a measure that continued the very risk that the ban sought to halt (Asbestos AB, ¶¶168, 174). In addition, France did not have to justify its ban on a product with known risks by showing that other products were less dangerous (Asbestos Panel, ¶8.221). In other words, absence of scientific certainty about the safety of alternatives could not be used to undermine France’s protective measures in relation to asbestos. Finally, it is worth noting that the necessity test does not apply at all to precautionary measures that are aimed at conservation of natural resources. The validity of trade restrictions introduced to conserve exhaustible natural resources is considered under Article XX(g). This provides that the trade measure need only ‘relate to’ the conservation objective. It requires that there be some ‘means-end’ connection between the measure and the conservation objective, but does not require the prior exploration of any alternatives, reasonable or otherwise. While Article XX(g) makes no explicit mention of precautionary measures, it requires a lower threshold than proving the necessity of the measure, even on the AB’s relaxed test, and thus supports higher levels of precaution for conservation measures. The language of Article XX(g) is not reproduced in the TBTA or SPSA, where only the necessity and least trade-restrictive tests apply. 3.5

Scientific Justification

The TBTA and SPSA share a number of common requirements that are not found in the GATT, most notably the harmonization of domestic standards. The most significant difference between the two agreements is the SPS regime’s emphasis on science to justify domestic measures. The requirement that measures be based on ‘sufficient science’ (SPSA Article 2.2) has dominated critiques of the agreement, with vastly differing views on the extent to which it compromises domestic precautionary autonomy. Authors like Howse, for example, argue that the science requirements provide ‘comprehensive and accurate information about risks and their costs and benefits’ and thereby enhance domestic decision making (Howse 2000, p. 2330). Sykes, on the other hand, argues that while a scientific justification aids in motive review, ‘meaningful scientific evidence requirements fundamentally


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conflict with regulatory sovereignty in all cases of scientific uncertainty’ (Sykes 2002, pp. 354–355). 3.5.1 Sufficient scientific basis and the SPSA The SPSA’s requirement of sound science is achieved by undertaking a risk assessment (SPSA Articles 3.3 fn2, 5.1). The WTO dispute settlement tribunals have endeavoured to safeguard domestic precautionary autonomy in their interpretation of risk assessment requirements, but are constrained by the language of the SPSA itself. The definition of risk assessment reveals two biases in favour of human health over plant or animal safety. Firstly, risk assessment for food-borne risks needs only to determine the potential or possibility of health threats from a food additive, residue, contaminant or disease. This does not require any ‘minimum degree of risk’ (SPSA Annex A.4; EC-Hormones AB, ¶183), which accords with the idea that the amount of evidence required should be lower where risks are of very serious or irreversible harm. Risk assessments for the spread of pests and diseases, on the other hand, require an evaluation of the likelihood or probability of entry, establishment and spread of pests and diseases (Salmon AB, ¶121). While this assessment may be qualitative or quantitative, it still implies the need for a higher threshold of scientific evidence before measures may be said to be ‘based on sufficient scientific evidence’ (SPSA Annex A.4; Salmon AB). The second bias is that the risk assessment for spread of pests and disease requires a calculation of the associated biological and economic consequences of such a spread but those for health risks do not (SPSA Annex A, ¶4). The definition of risk assessment speaks of associated biological and economic consequences, but SPSA Article 5.3 only elaborates the relevant economic risks. Article 5.3 provides that: . . . Members shall take into account as relevant economic factors: the potential damage in terms of loss of production or sales in the event of the entry, establishment or spread of a pest or disease; the costs of control or eradication in the territory of the importing Member; and the relative cost-effectiveness of alternative approaches to limiting risks.

This emphasis could result in some bias against consequences that are difficult to express in economic terms. In some circumstances, the economic costs of pests or disease could be so high that including economic considerations will actually advance the case for precautionary measures, but this is only likely where the risk relates to some commercially valuable land or resource. The less onerous risk assessment obligations imposed in relation to food safety (potential not likely risk; no economic factors) are explicable on

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anthropocentric political grounds. But damage to an ecosystem or environmental values from the spread of pests or diseases is more likely to be irreversible than food-borne risks. In this respect, the higher standard or persuasiveness of evidence required is at odds with a precautionary approach. Aside from these textual biases, the SPS requires Members to assess the specific risks created by the product whose importation or use is restricted. The AB in EC-Hormones rejected general evidence of a relationship between hormones and cancer: to serve as a basis for the beef ban, the risk assessment had to relate specifically to growth-promoting hormones in food (EC-Hormones AB, ¶¶196–199). Similarly, in Japan-Varietals, the Panel rejected Japan’s risk assessment in relation to the introduction of codling moth. Although Japan had identified differences in fruit varieties that could affect the efficacy of measures to eliminate the moth, it had not adduced evidence of any case in which treatment of one variety failed on another variety (Sykes 2002, p. 363). In Japan-Apples, the AB found that Japan had failed to address the specific risk of fire blight arising from apple imports, rather than the general risks of fruit-borne fire-blight (JapanApples AB, ¶¶203–206). Analysis of the SPSA itself shows that the textual justification for the AB’s strict specificity requirement is weak. The definition of risk assessment does not demand it, nor does Article 5.1’s stipulation that SPS measures be based on risk assessment. While the focus of dispute resolution is WTO-consistency of the measure complained of, this should not also circumscribe the scope of the risk assessment that informs the decision to take a measure. An element of remaining uncertainty concerning the scope of SPS risk assessment obligations is the relevance of non-scientific factors. These include evidence of public perceptions and ethical preferences, and nonscientific ‘evidence’ of risks, such as lay persons’ observations and traditional or indigenous knowledge. Inclusion of these issues is important to precautionary decision making if we accept that different societies have different perceptions of risk, and that science is neither infallible nor valuefree. Risk assessment theory generally favours limiting assessments to purely scientific inquiries, leaving the political and social factors to be considered in the risk management phase during which measures are selected and implemented (Nunn 2001, p. 95; Wirth 1994, p. 833). The SPSA draws no such distinction explicitly (EC-Hormones AB, ¶181). The AB has rejected a purely science-based approach to risk assessment, saying that the risk to be assessed is not just risk assessable under strictly controlled scientific conditions, but the ‘risk in human societies as they actually exist . . . the actual potential for adverse effects on human health in the real world where people live and work and die’ (EC-Hormones AB, ¶187).


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Even if the risk assessment process does permit non-scientific considerations, however, these presumably cannot override or replace the need for the measure to be based on ‘sufficient scientific evidence’ under SPSA Article 2.2. This makes the inclusion of social or political factors ultimately irrelevant to the risk assessment stage, leaving them to be considered in the determination of ‘appropriate levels of protection’ and choice of measure. The amount of scientific evidence required to justify a precautionary SPS measure is obviously critical to any assessment of the WTO’s precautionary credentials. Risk assessment should produce ‘sufficient scientific evidence’, but ‘sufficiency’ is a relational concept (Japan-Varietals AB, ¶22) and must be determined on a case-by-case basis. The AB has said that there needs to be a rational and objective relationship between the findings of the risk assessment and the choice of SPS measures. Evidence must ‘sufficiently warrant’ or ‘reasonably support’ the measure (EC-Hormones AB, ¶93; Salmon Panel, ¶8.94), but this does not mean that Members must base SPS measures on majority scientific opinion. In the face of scientific uncertainty over serious health or environmental impacts, prudent governments may rely on credible minority views (EC-Hormones, ¶¶193–194; Japan-Varietals AB, ¶¶ 73–84; Japan-Apples AB, ¶¶145, 162). Despite the reassurances about majority and minority science, however, the AB has rejected ‘minority science’ measures in all four cases considered to date, substituting its or the Panel’s assessment of the weight of science and the precautionary imperative for that of the Member maintaining the measure. The gap between the AB’s statements on minority science and its decisions to date may be attributable to the SPSA’s requirement that risk assessments for pest and disease risks must assess the probability of spread or damage. If a measure is to be based on a risk assessment, and that assessment must determine probability, a minority view will, by definition, be insufficient. 3.5.2 Provisional measures under the SPSA The SPSA does not rule out precautionary SPS measures where insufficient evidence is available on which to evaluate risk fully. In such cases, it permits provisional measures, provided that: they are adopted ‘on the basis of available pertinent information’; additional evidence is obtained to perform a more objective risk assessment; and provided the measure is reviewed within a reasonable period of time (SPSA Article 5.7; Japan-Varietals AB, ¶89). Some see this as the WTO’s principal reflection of precaution, but its operation may not be as favourable as originally imagined. Only if there is in fact insufficient evidence to permit the evaluation of risk can SPSA Article 5.7 be relied on (Japan-Apples AB, ¶179). Japan failed this test in the Japan-Apples dispute because the panel found that there was a large

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quantity of high quality, reliable scientific evidence on the risk of transmission of fire-blight through apple fruit. Although Japan took a contrary view of the evidence, it produced no evidence of its own to refute its credibility or persuasiveness (Apples Panel, ¶¶7.9, 8.216–219). If evidence exists with which to conduct a risk assessment and to conclude that the risk was negligible, the fact that a national measure does not do so does not permit reliance on Article 5.7 (Japan-Apples AB, ¶182). This raises important questions about how the SPSA deals with scientific indeterminacy or ‘irreducible uncertainty’ that demands precautionary policies. In any given case there may be a significant body of reliable evidence pointing to a particular conclusion, but rarely will scientific conclusions be completely certain. The real question for precautionary decision making in the SPSA, therefore, is how Members may respond to this potential for science to be wrong, in the face of strong evidence pointing to one conclusion. In Japan-Apples, the AB emphasized that Article 5.7 is invoked by the insufficiency of scientific evidence upon which to base a risk assessment, not by scientific uncertainty as such (Japan-Apples AB, ¶184). These two concepts are not interchangeable. Regrettably, the AB went no further in elaborating the issue. It said that Article 5.7 is broad enough to be invoked where there is a substantial quantity of evidence, if its quality is unreliable (Japan-Apples AB, ¶185). In Japan-Apples, the AB was satisfied that all available evidence pointed to the safety of importing US apples, so it could not be said that there was insufficient evidence on which to conduct a risk assessment. To avoid the rigorous SPSA risk assessment obligations by relying on Article 5.7, additional evidence must be obtained and a more objective appraisal of risk undertaken within a ‘reasonable period of time’ (SPSA Article 5.7; Japan-Varietals AB, ¶¶89, 92). What constitutes ‘a reasonable period’ will be case-specific, and will depend on factors like the nature of the risk, the availability of evidence or testing techniques, and the nature of the SPS measure (Japan-Varietals AB, ¶¶89–94; EC 2000). The AB has acknowledged that in some cases where reliable evidence is clearly inadequate, it may take quite some time to gather scientific knowledge, but it nonetheless contemplates that sufficient evidence will eventually be available in order to form a view about the level of risk posed by an activity or product. It thus precludes permanently precautionary measures that are based upon irreducible uncertainty, converting precaution into a ‘postponement principle’. As Nunn explains it, SPS obligations ‘preclude the ongoing or indefinite use of the precautionary principle as grounds for not taking a decision on any import access request’ (Nunn 2001, p. 101). This is a significant limitation on the capacity of the SPSA to accommodate genuinely precautionary, rather than preventive, SPS measures.


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3.5.3 Scientific requirements under GATT and TBTA The GATT and TBTA contain neither an express substantive requirement of scientific justification nor a procedural requirement for risk assessment similar to those contained in the SPSA. Satisfying the GATT Article XX exception that a measure is ‘necessary to protect human, animal or plant life or health’ or ‘related to the conservation of exhaustible natural resources’ will nonetheless require some scientific evidence of a risk. In Asbestos, the AB applied the language of the SPSA risk assessment requirements to its analysis of Article XX(b), and decided that Members were not obliged to follow ‘majority scientific opinion’ (Asbestos AB, ¶178). This signals a greater willingness to defer to national judgements about what risks are unacceptable and to accept legitimate precautionary measures as satisfying Article XX(b). As noted above, however, this was not a case where the AB had to assess a Member’s reliance on minority science, since the scientific evidence of the carcinogenicity of asbestos is extremely strong. The policy objective underpinning many TBTA measures is not scientifically provable. For example the prevention of fraudulent or deceptive practices is a social policy, not based in science. Science would therefore have been an inappropriate criterion by which to measure all TBT measures, so there is no express science requirement in the TBTA. That is not to say, however, that scientific evidence is irrelevant in disputes involving claims of safety, public health or environmental protection. Where the objectives of a technical regulation do concern human health or environmental protection, it is highly likely that panels will employ the same threshold as under GATT Article XX. A full SPS-style risk assessment will not be required, but some credible scientific basis for the measure must be established. The strength of the available science in Asbestos makes it hard to predict whether the AB will respect Members’ rights to prefer credible minority scientific opinion in more marginal cases, so the TBTA’s deference to precaution is an open issue. Scientific evidence also finds its way into the TBTA’s assessment of whether a regulation is ‘not . . . more trade-restrictive than necessary to fulfil a legitimate objective’ (TBTA Article 2.2). In determining whether a measure is necessary, one relevant factor is the risks created by not fulfilling the policy objective. Available scientific and technical information is one of the factors to be taken into account in assessing those risks. Science therefore plays a role in demonstrating the seriousness of the need for precautionary measures, but is not subject to a minimum threshold of sufficiency. This potentially leaves more scope for precautionary autonomy in respect of technical regulations than the science-based SPS measures. The TBTA lacks an equivalent to SPSA Article 5.7, however, so it may be harder to make provisional technical regulations under the TBTA.

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3.6


Regulatory Consistency and Precaution

The SPSA requires Members to avoid arbitrary differences in the level of protection they apply in similar circumstances or to address similar threats. Even where the scientific basis for a measure can be established, therefore, Members that introduce protective measures against one source of risk without simultaneously addressing other sources of risk may be challenged (SPSA Articles 2.3, 3.5 and 5.5; Salmon AB, ¶140). GATT and TBTA (GATT Article XX and Preamble; TBTA Preamble) also demand ‘regulatory consistency’. These obligations require Members to avoid differences in choice of regulatory effort that reveal ‘arbitrary or unjustifiable differences’ in their treatment of comparable situations (Salmon AB, ¶140). As I suggested earlier in this chapter, inconsistency in domestic precautionary priorities may be attributable to differing public pressures, perceptions and values. From a trade perspective, such differences may seem arbitrary, but they may reflect the democratic choices of a particular society or culture. Citizens’ perceptions and tolerance of risk are affected by how controllable the risk is, whether it is assumed voluntarily, the permanence of potential losses, the distribution of dangers and benefits, and the resilience or marginalization of likely victims (Sunstein and Pildes 1997, p. 133). A broad principle of precaution embraces these differences, but requiring consistency potentially constrains them. SPSA Article 5.5’s regulatory consistency requirement is offset in part by the stipulation that ‘arbitrary or unjustifiable’ difference in the treatment of comparable situations requires proof of discrimination between members (EC-Hormones AB, ¶245; Salmon AB, ¶158). This is determined on the facts of each case, so one way in which the consistency requirement could be maintained while still respecting differences in risk priorities would be to permit inconsistency where Members undertake to review the regulation and use of goods or activities that pose comparable risks, to bring them into line over time (EC-Hormones AB, ¶¶239–240). This could have assisted the Australian position in Salmon, for example, where a principal weakness of Australia’s salmon import ban was the failure to impose equivalent restrictions on imports of bait fish and aquarium fish that posed identical risks to commercial salmon fisheries and other marine species. 3.7

Summary

In addition to systemic constraints, the requirements of ‘necessity’ and ‘least trade-restrictiveness’ that are found in all the agreements dealing with trade in goods can limit the scope for early precautionary measures. The extent of this constraint has been ameliorated by the AB’s recent relaxation


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of the ‘necessity’ requirement. A Member’s obligation to explore less restrictive alternatives is now limited to those that can achieve the level of protection a Member seeks. Coupled with comments that the assessment of necessity may take account of ‘minority scientific opinion’, it appears that the dispute settlement tribunals are attempting to strike an appropriate balance between Members’ precautionary autonomy and WTO obligations, at least in relation to the GATT. Just how respectful of precautionary autonomy the SPSA’s ‘sufficient science’ and risk assessment requirements are capable of being is still unclear. There have still only been five disputes that have turned on these obligations and many would say that these have been poor test cases for genuinely precautionary measures. Despite their factual weaknesses, however, it is worth noting that, following the AB’s ruling in EC-Hormones that the EC ban on hormone-treated beef was SPSA inconsistent, the EC chose to compensate North American beef exporters rather than lift its ban, at least pending further research into the health effects of growth hormones in food. After Salmon, Canada made concessions that exempted Australia’s island state of Tasmania from the obligation to accept salmon imports. These outcomes suggest that the SPS motivations behind many restrictions will genuinely reflect national precautionary autonomy, despite any regulatory inconsistency between the measures.

4. PRECAUTIONARY DECISION MAKING ON WTO UNDERTAKINGS If the precautionary principle should be invoked wherever activities involve a risk of serious or irreversible environmental harm, a focus on WTO dispute settlement and interpretation of existing texts is very much a case of ‘shutting the GATT once the horse has bolted’. There is substantial evidence that trade liberalization itself produces a range of environmental effects – both negative and positive – by expanding the scale of production, shifting patterns of production and economic activity, and increasing transport impacts (OECD 1994). These impacts flow from the implementation of new liberalization commitments. They are often caused by the expansion of economic activity and associated pollution and resource exploitation generated by trade liberalization. Rather than expecting the AB to tread an interpretive tightrope, the implementation of precautionary decision making when new agreements are negotiated would be far more effective to ensure that the agreements themselves reflect a precautionary bias. There have already been numerous assessments of the environmental impacts of trade liberalization by national governments, non-government

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organizations, academics and inter-governmental organizations like the OECD (Kirkpatrick and Morrissey 1999; Bermudez 2004; OECD 2000). These have involved entire undertakings, such as the Uruguay Round commitments, or particular sectors or agreements, such as the GATS or North American Free Trade Agreement (OECD 2000). They provide useful information about the kinds of risks posed by further liberalization and this knowledge may therefore trigger precautionary obligations in respect of future negotiations. The WTO as an organization has undertaken neither ex ante nor ex post assessments of the environmental impacts of new undertakings. These are negotiated on the basis of predictions of economic gain, with considerable faith placed in the ‘grow now, pay later’ philosophy regarding any environmental consequences. Given the significant uncertainties inherent in the economic assumptions and modelling that underpins these predictions, and the potential for significant environmental impacts, the case for a precautionary approach is strong. Of course, the complexity of environmental impacts makes any assessment of new undertakings extremely difficult. Moreover, the trend towards negotiating composite packages of commitments or ‘single undertakings’ will make it hard for Members to single out particular agreements based on the risks of adverse environmental effects. Environmental impacts will vary from Member to Member depending on their economic status, existing levels of trade restriction, natural resource endowment and domestic regulatory framework for environmental protection. If these variables affect the patterns for individual Members, their interrelationship across the entire Membership and for a complex array of undertakings is considerably harder to analyse. As a first step, however, it is reasonable to expect individual Members to determine whether new commitments will undermine domestic precautionary policies and their ability to fulfil precautionary international environmental undertakings. Properly executed, impact assessment of new undertakings should result in a general increase in precautionary decision making, by informing individual Members’ negotiating positions on undertakings, enhancing any assessment of the true benefits of liberalization, and identifying appropriate mitigation or ‘flanking measures’ (OECD 2000, 16; Bermudez 2004). The United States has committed to undertaking environmental reviews of new trade agreements (United States Trade Representative (USTR)/ Council on Environmental Quality (CEQ) 2000), much like domestic environmental impact assessment procedures for new developments and activities. These reviews are to be undertaken sufficiently early to inform national negotiating positions (USTR/CEQ 2000, ¶12). The triggers recognize impacts on both specific resources or areas and general impacts of altering


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trade flows, as well as constraints on regulatory autonomy (USTR/CEQ 2000, ¶2). The primary concern of the US impact assessment process is domestic environmental quality, but the scoping process may also reveal global and transboundary impacts that demand further investigation. The availability of relevant data and analytic tools and diplomatic considerations will influence whether such impacts are included in domestic reviews (USTR/CEQ 2000, ¶8). The EC has also embraced impact assessment of trade agreements, but it attempts to assess overall ‘sustainability’, adding social and developmental factors to the environmental impact mix. The EC has applied a complex sustainability assessment methodology in analysing sectoral liberalization proposals (Kirkpatrick and Morrissey 1999; Bermudez 2004), but has not comprehensively assessed an integrated suite of trade reforms of the kind that are likely to occur simultaneously as part of a Doha Round single undertaking. UNEP, the Commission on Sustainable Development and WWF International have also developed guidelines for developed and developing countries on how to assess the environmental, social and economic impacts of trade undertakings, but developing country implementation of SA methodology is still extremely limited (Bermudez 2004, 6; CLAES, FARN and WWF 2003). 4.1

The Development of International Standards

The SPS and TBT agreements are ‘incomplete contracts’, in that they delegate rule-making power regarding international standards to specified standard-setting bodies, such as Codex Alimentarius and the International Organization for Standardization (ISO). Compliance with these standards presumptively satisfies the ‘necessity’ tests of both the SPSA and TBTA (SPSA Article 3.2; TBTA Article 2.5). It also appears that Members with existing domestic regulations should review them whenever new international standards are developed, to consider the appropriateness of adopting the new standard instead (EC-Sardines Panel, ¶7.79; EC-Hormones AB, ¶128). Higher domestic measures may be maintained if the international standard is not effective and appropriate to achieve the chosen policy objective, but the presumptive power of international standards is undeniable. What were previously advisory guidelines now carry much greater legal force: a form of ‘delegated legislation’ under the WTO agreements. Despite their growing importance, there has been very little scrutiny of the composition or decision-making processes of these bodies or the extent to which the development of standards takes a precautionary approach (Atik 1997, p. 744). The following discussion uses the body responsible for food safety standards, the UN FAO/WHO Codex Alimentarius Commission

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(Codex) to illustrate the deficiencies of the current framework, since no other body has grappled with the relevance of precaution to its decisionmaking processes. Codex was established to develop international standards for food and food products in order to protect the health of consumers and to ensure ‘fair trade practices’ (Codex Statute Article 1). Codex does not currently adopt the precautionary principle to inform its standard-setting functions. In 2001, it adopted the position that: . . . When there is evidence that a risk to human health exists but scientific data are insufficient or incomplete, the Commission should not proceed to elaborate a standard but should consider elaborating a related text, such as a code of practice, provided that such a text would be supported by the available scientific evidence (Codex Alimentarius Commission 2001, p. 43).

The Codex Manual recognizes that precaution is an inherent element of risk analysis and that there are many sources of uncertainty in risk assessment and management processes. It provides that uncertainty should be explicitly considered in the risk analysis and that if there is enough evidence on which to develop a standard, the risk management options should reflect the degree of uncertainty and the characteristics of the hazard (Codex Alimentarius Commission 2001, p. 43). This rather unhelpful compromise text highlights the inability of Codex members to accept even the weakest form of precaution. Indeed, it seems to prefer a decidedly un-precautionary approach, namely to postpone or preclude the development of clear standards until scientific data becomes available. The focus on science and risk assessment in Codex standard setting also fails precaution because it examines the particular additive or residue in isolation, rather than considering its cumulative effects. This approach is consistent with that of the WTO AB in relation to SPSA risk assessment. But both are inconsistent with the experience of exposures and tolerance levels in the real world, in which people and receiving environments are subjected to a complex array of substances simultaneously. The harmonization of national food, quarantine and product standards based on international standards is a process to which existing WTO agreements have already committed. Virtually no consideration is given to issues of precaution in any of the standards organizations except Codex. In Codex, uncertainty over health risks is reason to avoid developing a standard – the very opposite of even the weakest non-preclusion formulation of precaution. Coupled with the heavy use of science-based, narrow risk assessments, and the influence of trade effects, the conclusion that precaution has no place in these delegated legislative activities is inescapable.


5.

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CONCLUSIONS

The precautionary principle is not referred to explicitly in any WTO Agreement. This leaves it to the WTO dispute settlement tribunals to define an appropriate role for precaution within the trade regime. In the established normative framework of trade liberalization, precautionary measures in areas of social and environmental policy are employed as defensive tools in dispute settlement – shields instead of swords. The test cases that inform our current understanding of WTO jurisprudence have not yet dealt with the full implications of Members’ precautionary autonomy. Where it has grappled with the issues, though, the Appellate Body (AB) has exercised extraordinary legal skill and political sensitivity, walking a tightrope between considerations of precautionary autonomy and the need for objective justification of trade-restrictive measures. It has reduced or resolved some concerns, but major points of contention remain in respect of the WTO’s necessity, consistency and harmonization requirements, and its general emphasis on science as a prerequisite for protective measures. The situation whereby the precautionary principle must be employed to defend non-trade measures highlights the importance of applying a rigorous precautionary approach to the agreement of trade undertakings in the first place. However well the dispute settlement process adopts precautionary approaches to existing texts, tr(e)ading cautiously demands a commitment to precautionary decision making in the development of those texts. There is a growing literature on sustainability or environmental assessment of trade agreements, but practice remains patchy and its results or recommendations are difficult to discern in the negotiating positions of Members, much less the Organization as a whole. The presumptive consistency of international standards under some WTO agreements also makes it important to ensure that those standards are set with precaution in mind. The mandates and standard-setting procedures of the major bodies like Codex and ISO fall far short of this objective. The WTO’s precautionary sensitivity will continue to be limited until WTO legislative and quasi-legislative decision making considers potential environmental and health risks, even where those risks are uncertain or ill-defined.3

NOTES 1. School of Law, Griffith University, jan.mcdonald@griffith.edu.au. The law is correct as at September 2004. 2. Unlike Article XX of the GATT, the necessity obligations in the TBTA and SPSA do not operate as defences to general obligations, but are themselves core obligations, although this may make little difference in the practice of dispute resolution.

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3. The procedures for standards development and decision making in ISO have been assessed and critiqued elsewhere (Hauselmann 1996).

REFERENCES Atik, J. (1997), ‘Science and international regulatory governance’, Northwestern Journal of International Law and Business, 17, 736–58. Bermudez, E. (2004), Sustainability Assessments of Trade Policies and Programmes, Technical Report, January 2001–December 2003, Gland: WWF International. Birnie, P. and A. Boyle (2002), International Law and the Environment, 2nd edn, Oxford: Oxford University Press. Cameron, J. (1999), ‘The precautionary principle’, in G. Sampson and W. Chambers (eds), Trade, Environment and the Millennium, Tokyo: United Nations University Press, pp. 240–69. Central Laboratory for Agricultural Expert Systems (CLAES), Fundación Ambiente y Recursos Naturales (FARN) and World Wildlife Fund (WWF) (2003), Comments on the Proposed Methodology: EC Sustainability Impact Assessment of the Trade Aspects of the EU-Mercosur Association Agreement – Draft Inception Report, Gland: WWF International. Codex Alimentarius Commission (2001), Procedural Manual of the Codex Alimentarius Commission, 13th edn., Rome: FAO. European Commission (2000), Communication from the Commission on the Precautionary Principle, COM(2000)1 final, available at http://europa.eu.int/ comm/dgs/healthconsumer/library/pub/pub07_en.pdf. (accessed 21 October 2005). Harremoës, P., D. Gee, M. MacGarvin, A. Stirling, J. Keys, B. Wynne and S. Guedes Vaz (eds) (2002), The Precautionary Principle in the 20th Century: Late Lessons from Early Warnings, London: Earthscan. Hauselmann, P. (1996), ISO Inside Out: A WWF International Discussion Paper, Gland: WWF International. Howse, R. (2000), ‘Democracy, science, and free trade: risk regulation on trial at the WTO’, Michigan Law Review, 98, 2329–57. Kirkpatrick, C. and O. Morrissey (1999), WTO New Round Sustainability Impact Assessment Study Phase One Report, Manchester: Institute for Development Policy and Management and Environmental Impact Assessment Centre, University of Manchester and Centre for Research on Economic Development and International Trade, University of Nottingham. Nunn, M. (2001), ‘Allowing for risk in setting standards’, in D. Robertson and A. Kellow (eds), Globalization and the Environment, Cheltenham, UK and Northampton, MA, USA: Edward Elgar, pp. 95–105. Organization for Economic Co-operation and Development (OECD) (1994), The Environmental Effects of Trade, Paris: OECD. Organization for Economic Co-operation and Development (OECD) (2000), Assessing the Environmental Effects of Trade Liberalisation Agreements: Methodologies, Paris: OECD. Sunstein, C. and R. Pildes (1997), ‘Experts, economists and democrats’, in C. Sunstein (ed.), Free Markets and Social Justice, New York: Oxford University Press, pp. 133–48.


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Sykes, A. (2002), ‘Domestic regulation, sovereignty, and scientific evidence requirements: a pessimistic view’, Chicago Journal of International Law, 3 (2), 353–68. United States Trade Representative and Council on Environmental Quality (2000), Guidelines for the Implementation of Executive Order 13141 – Environmental Review of Trade Agreements, Washington, DC: USTR/CEQ. Wirth, D. (1994), ‘The role of science in the Uruguay Round and NAFTA trade disciplines’, Cornell International Law Journal, 27, 817–59.

WTO Reports Australia – Measures Affecting Importation of Salmon, Report of the Appellate Body (‘Australia-Salmon AB’) WT/DS18/AB/R, 20 October 1998. Australia – Measures Affecting Importation of Salmon, Report of the Panel (‘Australia-Salmon Panel’) WT/DS18/R, 12 June 1998. European Communities – Measures Affecting Asbestos and Asbestos-Containing Products, Report of the Appellate Body (‘EC-Asbestos AB’) WT/DS135/AB/R, 12 March 2001. European Communities – Measures Affecting Asbestos and Asbestos-Containing Products, Report of the Panel (‘EC-Asbestos Panel’) WT/DS135/R, 18 September 2000. European Communities – Measures Concerning Meat and Meat Products (Hormones), Report of the Panel (‘EC-Hormones Panel’) WT/DS26/R and WT/DS48/AB/R. European Communities – Trade Description of Sardines, Report of the Appellate Body (‘EC-Sardines AB’) WT/DS231/AB/R, 26 September 2002. European Communities – Trade Description of Sardines, Report of the Panel (‘ECSardines Panel’) WT/DS231/R, 22 May 2002. Japan – Measures Affecting Agricultural Products, Report of the Appellate Body (‘Japan-Varietals AB’) WT/DS76/AB/R, adopted 19 March 1999. Japan – Measures Affecting the Importation of Apples, Report of the Appellate Body(‘Japan-Apples AB’) WT/DS245/AB/R, 15 July 2003. Japan – Measures Affecting the Importation of Apples, Report of the Panel (‘JapanApples Panel’) WT/DS245/R, 15 July 2003. Korea – Measures Affecting Imports of Fresh, Chilled and Frozen Beef, Report of the Appellate Body (‘Korea-Beef AB’) WT/DS161/AB/R, 11 December 2000. Thailand – Restrictions on Importation of and Internal Taxes on Cigarettes, Report of the Panel (‘Thai-Cigarettes Panel’), GATT Document DS10/R (1990) BISD 39S/200. United States – Restrictions on Imports of Tuna, Report of the Panel (‘Tuna-Dolphin I’), GATT Document DS 21/R (1991) 40S/155 (unadopted), reprinted in (1991) 30 ILM 1594. United States – Restrictions on Imports of Tuna, Report of the Panel (‘Tuna-Dolphin II’), GATT Document DS 29/R (1994) (unadopted) reprinted in (1994) 33 ILM 842.

9. The threshold test of the precautionary principle in Australian courts and tribunals: lessons for judicial review Warwick Gullett INTRODUCTION The increasing preparedness of Australian environmental managers to rely on the precautionary principle when exercising their legislative powers is testament to the principle’s usefulness regarding a range of environmental management challenges. However, Australian legislation provides limited support for precautionary decision making because it adopts a vague formulation of the principle and appears to limit its application to circumstances when there are ‘threats of serious or irreversible environmental damage’. Further, many environmental management agencies remain without express legislative instructions either to consider or apply the principle. The combination of a weak legislative mandate for precautionary decision making, and its potentially significant economic consequences for affected individuals, raises the prospect of a new wave of judicial review challenges against decisions which are arguably impermissibly precautionary. Such legal challenges to decisions made by environmental and planning agencies may not only result in their invalidation; they may also shape administrative culture in using the principle. This makes it necessary for care to be taken in how the principle is incorporated into rules and regulations so that decisions of government departments and agencies can be made in a manner consistent with the philosophy behind it. The Australian experience reveals that the legislative formulation of the principle may be pivotal in determining the lawfulness of precautionary management decisions. This experience is informative for other jurisdictions which embed the principle in legislation. The adoption of the precautionary principle in Australian environmental legislation, despite its lengthy history, has failed to come with clear guidance regarding the two central issues raised by it: (1) when does the need to 182

The threshold test of the precautionary principle in Australian courts

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act with precaution arise? (the threshold question) and (2) what does the duty to consider or act with precaution entail? (the content question). Notwithstanding the reticence of the judiciary to flesh out these issues and the absence to date in Australia of a successful judicial review challenge to a statutory authority’s interpretation or application of the principle, imprecise legislative instructions may not preclude the principle being used as the basis for a successful judicial review action. Most litigation has consisted of an objector unsuccessfully arguing that a statutory authority or government department failed to fulfil properly its legislative duty to take the principle into account when arriving at a decision (Gullett et al. 2001). Put simply, the unsuccessful argument in these cases was that the administrative decision being reviewed, or the process leading to the decision, was not precautionary enough. However, there is increasing acceptance of the precautionary principle by environmental managers and preparedness on their part to use it as a justification for their decisions. In some cases, more robust legislative incorporation of the ecologically sustainable development (ESD) concept may have facilitated increased reliance on the principle. Also, some environmental legislation enacted prior to the principle’s widespread adoption in policy instruments in the early 1990s has been updated to include the principle.1 However, in many cases, statutory authorities have received no further grant of legislative power to make precautionary decisions. Indeed, many statutory environmental authorities are given no express legislative instruction to consider the principle,2 despite it being entrenched in environmental policy. A consequence of increased reliance on the principle by statutory authorities is the emergence of a new group of legal objectors who are aggrieved by the effects of precautionary decisions. This is because the principle can be used to justify significant regulatory intervention with financial or other consequences for individuals or companies. For example, in the fisheries management context, the principle can be used to impose restrictions on the use of commercial fishing licences,3 require increased monitoring of threatened species,4 prohibit the landing of bycatch species,5 close fisheries due to the impact on bycatch species6 and to refuse to grant permits.7 Opponents to a specific ‘precautionary’ decision will be exploring ways to argue that an environmental agency fell into legal error by making a decision that was too precautionary. Although courts need to be wary about ‘enthusiastically’ dissecting administrative decision making ‘in a desperate bid to discover legal error’ (Bates 2002, p. 188), the formulation of the principle in Australian legislation presents the possibility of environmental managers engaging in precautionary decision making without adequate legislative support for doing so. This chapter assesses the susceptibility of ‘precautionary’ decisions to successful judicial review challenge. It reviews litigation in Australia

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concerning the principle to assist in the identification of arguments that could be raised in future judicial review challenges. Most of the cases reviewed were merits review appeals and they differ from the way in which judicial review challenges need to be argued. The principal difference between merits review and judicial review is that the former allows for wideranging review of administrative decisions, and the tribunals or various state specialist environmental courts empowered to hear them are able to substitute a new decision for the one being reviewed; whereas judicial review cases can only be heard in courts and are limited to a determination of whether or not the decision under review was made lawfully. Nevertheless, merits review cases, including the famous Leatch case,8 represent almost the entire body of litigation in Australia on the principle and shed light on how statutory expressions of the principle are interpreted, and how courts faced with judicial review challenges may deal with them. The chapter focuses on the threshold question and on fisheries management, an area in which challenges to precautionary decisions have commenced.

THE PRECAUTIONARY PRINCIPLE IN AUSTRALIAN LEGISLATION The two critical aspects of the legislative adoption of the principle are the formulation of it and the express or implied duty associated with it. A remarkable aspect of Australia’s legislative experience with the principle is that there is a uniform formulation. Every piece of Australian legislation that includes the principle either uses the definition given to it in the 1992 Intergovernmental Agreement on the Environment (IGAE) or defines it in a manner substantively identical to the IGAE formulation. Clause 3.5.1 of the IGAE provides that: Where there are threats of serious or irreversible environmental damage, lack of full scientific certainty should not be used as a reason for postponing measures to prevent environmental degradation. In the application of the precautionary principle, public and private decisions should be guided by: (i) careful evaluation to avoid, wherever practicable, serious or irreversible damage to the environment; and (ii) an assessment of the risk-weighted consequences of various options.

This formulation does not provide a strong mandate for the use of precaution in environmental management. This is because the measures that are


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needed to give effect to the principle are not clearly spelled out. There is only an instruction about what should not be done. Further, this formulation utilizes preventive rather than precautionary phraseology. It focuses on responding to risk (including ‘serious’ and ‘irreversible’ damage) rather than uncertainty, which is the essence of the principle (Gullett 2000, p. 101). The apparent haste with which this version of the principle was entrenched in Australian policy and legislation resulted in a missed opportunity for Australia to develop a more workable formulation. Although Canada eclipses Australia in having the vaguest definition of the precautionary approach (simply, ‘erring on the side of caution’),9 the IGAE formulation of the principle is nebulous with the exception of its statement of the threshold for its operation. The duty associated with the principle in legislation is normally the nonrigorous duty of having ‘regard’ to it in the process of decision making. However, there are now a handful of pieces of legislation which cast ESD objectives in a more substantive manner, indicating a positive duty on public agencies to achieve certain outcomes. The most onerous legislative duty with respect to the principle in Australian legislation is contained in section 3(1)(b) of the Fisheries Management Act 1991 (Cth): 3 Objectives (1) The following objectives must be pursued . . . in the administration of this Act . . .: ... (b) ensuring that the exploitation of fisheries resources and the carrying on of any related activities are conducted in a manner consistent with the principles of ecologically sustainable development and the exercise of the precautionary principle . . .

Section 4 of the Act provides that the principle has the same meaning as in clause 3.5.1 of the IGAE. The remarkable aspect of this legislative adoption of the principle is the requirement that the principle be ‘pursued’ rather than simply ‘taken into account’, thus placing a positive duty on the Australian Fisheries Management Authority (AFMA) to advance the principle in some way (Gullett et al. 2001, p. 102). This phraseology accords more weight to the principle than where it simply needs to be considered, and necessarily structures decision making to this extent. However, guidance on how to apply this standard is not provided. It is to be noted that the principle is located alongside other instructions consistent with sustainability in the fisheries management arena such as considering the long term sustainability of the marine environment and the impact of fishing practices on non-target species. These objectives may provide additional support for precautionary decision making.

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The absence of clear guidance in legislation on when and how to apply the principle leaves environmental managers with little instruction about how to exercise their legislative duty lawfully to consider the principle or pursue the exercise of it. There is anecdotal evidence to suggest that some environmental managers are less confident that their decisions can withstand merits or possibly judicial review attack. We now consider whether an administrative decision that encompasses a high level of precaution can be rendered void in a judicial review action on the basis of a misconstruction of the legislation under which it was made.

THE JUSTICIABILITY OF PRECAUTIONARY DECISIONS The task of determining the legal boundaries of precautionary decision making is challenging by virtue of the principle’s normally platitudinous and poorly defined inclusion in legislation, and the common practice of locating it alongside other competing objectives. Further, there are a variety of ways in which the principle can be included in legislation. It can be expressly included in a preamble or objectives section,10 in a substantive provision,11 or implicitly where there is adoption of the sustainable development concept12 or where specific ‘precautionary’ instructions are given in the absence of mention of the principle itself.13 Further, even where the principle is arguably absent from a statute, it does not necessarily follow that it is an extraneous matter that cannot be considered. This is because its widespread acceptance in the environmental policy context has imbued it with general relevance for environmental decision making. Notwithstanding concern about its justiciability (that is, whether a dispute about its application is a matter that is capable of being adjudicated by a court), the principle has been recognized as a proposition of law that may be interpreted and applied in accordance with established grounds of review because it relates to decisions made under legislation (Fisher 2001). However, the principle is invariably intended to guide discretionary decision making rather than to determine particular outcomes. Nevertheless, it is well established that courts will not construe wide discretionary powers as being completely unfettered. A role of the courts is to ensure that administrators do not stray beyond the legislative powers conferred on them. Established rules include the requirement to consider relevant matters and prohibitions on considering irrelevant matters, making manifestly unreasonable decisions and exercising powers for purposes outside the legislative scheme. Concerns about the non-justiciability of the principle are confined to the issue of courts being an inappropriate forum to resolve the


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substantive nature of the principle’s application (Fisher 2001, p. 323). However, the legality/merits distinction in judicial review arguably provides the necessary safeguard for any potential trespass by a court on the merits of a decision (Finn 2002). Although the formulation of environmental policy is not a matter for the courts, once the executive formulates policy and places it in legislation, the implementation of that policy is subject to judicial scrutiny. Put simply, the fact that wide discretion is conferred on an administrator does not immunize a decision from challenge if there has been an abuse of legislatively conferred power. Further, courts have, for example, reviewed and ascribed content to other difficult legislative objectives placed alongside the precautionary principle notwithstanding the consequences of such determinations for future decision making.14 The ability to seek judicial review on the basis of the precautionary principle is most obviously available when legislation either expressly or implicitly establishes a procedural framework for making decisions in a manner consistent with it. The courts will then need to interpret such procedures where a dispute exists, specifically to determine whether there has been compliance with them (Fisher 2001, p. 333). What the courts cannot do, however, is determine a particular outcome after consideration of the principle. Indeed, an administrator may choose from a range of available precautionary responses to an identified threat (Gullett 1997, p. 60). Courts will necessarily employ self-restraint and not engage in intensive review of the substance of the decision where this can be distinguished from matters of procedure. If there is compliance with precautionary procedures, then the weight to be given to the principle in any final decision is a matter properly left to the administrator. Although an administrator’s interpretation and use of the principle is justiciable and reviewable according to established grounds, this does not necessarily mean that courts will be exacting in their search for the principle’s legal content. The case law bears out this observation (Gullett 1997). The main conclusion to be drawn from the case law is that where the principle is specifically included in legislation, a decision may be invalidated where there has been a failure to consider it. One reason why it is unsurprising that courts have not been rigorous in searching for the legal content of the principle is because most of the cases were reviewed on their merits and were in situations when an opponent to a decision raised the argument that the principle was not included sufficiently in the decision-making process. However, the absence of a unified detailed conceptualization of the principle has meant that courts have had little ability to identify its legal content and have generally deferred to a department’s interpretation or application of legislation. Further, it is rare to find an onerous positive duty associated with the principle in legislation with which courts need to ensure

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compliance. It is in this sense that Fisher (2001, p. 325) remarked that the principle, despite its popularity, ‘has not been a particularly sharp “sword” for litigants’. There is, however, the prospect for more penetrating review of the principle when opponents to a decision submit that a decision maker was too precautionary rather than not precautionary enough. This is because if a court rejects a submission that an agency’s ‘precautionary’ decision is unlawful then it must provide reasons why the consideration or application of the principle in the given case was within legal limits. In doing so, the fleshing out of the legal content of the principle can commence more easily. As an example, an objector’s submission that the principle’s high threshold test was not met in the particular circumstances of the case would need to be addressed squarely by the court. In such a situation, it is likely that more detail about the legal content of the principle (in the context of the particular legislation in the case) would emerge. Likewise, heavy reliance on the principle by a decision maker may be questioned where there is no mention of it in the relevant Act.

PURSUING PRECAUTION WHEN THE PRINCIPLE IS NOT TRIGGERED Can a ‘precautionary’ decision be invalidated where the principle was applied in circumstances not envisaged by the legislation? That is, were the facts of the case insufficient to ‘trigger’ the principle? This discussion proceeds on analysis of the IGAE definition of the principle, as this is the standard formulation used in Australia. Consideration is not given to whether a separate broader formulation can be applied by virtue of the principle’s regular appearance in environmental policy, in addition to its specific inclusion in legislation. The reasons for this are twofold: first, the formulation of the principle in Australian environmental policy is the same as its formulation in legislation. Secondly, primary attention and weight must be given to the actual words used in legislation. It would be permissible to consider key policy documents to assist in interpreting and ascertaining the meaning of the principle in legislation, but it would not be permissible to transplant a vaguer and more expansive formulation in place of the actual principle included in the legislation. A further point to dispense with is that any international treaty to which Australia is a party that adopts the principle in a more substantive manner than the IGAE formulation cannot add further support for precautionary decision making under legislation unless the legislation expressly gives effect to international precautionary obligations. However, the Australian


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legislation discussed here, with one partial exception,15 does not purport to do this.

THE THRESHOLD TEST IN AUSTRALIA The IGAE version of the principle sets as its threshold ‘where there are threats of serious or irreversible environmental damage’. It thus calls for response to threats involving a certain degree of evidence of the two elements of ‘risk’ – likelihood of occurrence and severity of consequences. This suggests that a high level of scientific understanding or proof is required before the principle can be invoked, thus limiting the ability to take anticipatory action before the threshold of ‘threat’ is reached. This limits action to situations when there is knowledge that a dangerous outcome is possible (or probable) rather than when there is uncertainty or only some indication that environmental harm may occur. As such, the IGAE sets out a high threshold for the application of the precautionary principle and consequently provides little support for precautionary, as opposed to preventative, decisions. Determination of the point at which there is a ‘threat’ of ‘serious’ or ‘irreversible’ environmental harm is necessarily subjective. Notwithstanding the amorphous nature of what constitutes a ‘threat’, if the principle is expressly included in legislation with a relatively specific assemblage of words for its threshold, then it seems correct to assume that the threshold was intended to have some effect and thus some level of proof of environmental harm is required to trigger the principle. Indeed, all versions of the principle require some indication that harm may result to justify regulatory intervention (Gullett 2000, p. 112). If the need for a threshold were dispensed with, then this would open up the prospect of arbitrary use of the principle (Fisher 1999, 90). We proceed on the basis that the legislative adoption of the principle requires some threshold to be determined for a power to be validly exercised under it. In a judicial review case when a decision to deny development approval is challenged for being too precautionary, it would be necessary for an objector to show why the development should proceed and to show that the environmental agency was impermissibly precautionary on the ground that the threshold had not been reached. The question remains of what evidence would be sufficient to discharge this burden. This is a concern that has been around since the early days of the principle. What level of proof of ‘serious or irreversible harm’ would permit a decision maker to exercise a power in the pursuit of the precautionary principle? The precautionary principle does not make it clear what degree of proof is required. The balance of probabilities is used in civil law as the standard

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of proof. By contrast, a 95 per cent confidence level is generally required in experimental sciences before the probability of an event occurring can be accepted (Bates 2002, p. 133). However, this is not necessarily appropriate in the environmental planning and regulation context in which the legal test is a complex mixture of scientific and non-scientific standards. Also, where the possible impact on the environment would be severe, it is reasonable to argue that the level of evidence required to take precautionary measures could be less rigorous than where the type of possible environmental damage feared is minor. With respect to a proposed development project where the prospect of serious or irreversible harm can be made out, the correct application of the principle would be for the responsible government agency to prohibit or restrict the development unless the proponent proves that harm will not occur, or that if such harm is a possibility, that it can be acceptably managed.16 Although it is a logical impossibility to prove a negative proposition, evidence could be brought forward which could lead to a conclusion that the risk of feared harm is within acceptable limits. If such evidence is adduced, then it could be argued that it would be an improper exercise of power to apply the principle with respect to a situation of low-level threat. In this sense, a precautionary decision would prima facie be permissible unless the weight of evidence shows that the feared level of threat is unlikely, or short of ‘serious’ or ‘irreversible’. In this case, support for the decision must be sought from other legislative objectives.

AUSTRALIAN CASE LAW AND THE THRESHOLD TEST Analysis of the cases demonstrates that they fall into two main types. The first group illustrates the reluctance of courts and tribunals to enquire deeply into the establishment of the threshold test. A good example is the decision of the Administrative Appeals Tribunal (AAT) in Justice v. AFMA.17 The case concerned a challenge by a commercial fisher to area conditions placed on his fishing permit. The AAT considered evidence presented by AFMA regarding limited knowledge of fish stocks and concluded that the evidence ‘urges a precautionary approach until better information becomes available’ so impacts could be managed most effectively.18 There was no suggestion that serious or irreversible damage was being caused to fish stocks. Rather, the suggestion was that careful evaluation to avoid such a predicament was advisable. As such, constraint of catch levels in the short term was considered to be consistent with the pursuit of ESD. The approach the AAT took in this regard is more consistent with precautionary philosophy than with


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the restrictive meaning given to it in the IGAE. This is because it refused to extend fishing effort in recognition of the need to avoid allowing activities in the absence of confident predictions of future environmental effects. AJKA Pty Ltd v. AFMA19 was an appeal in the AAT against AFMA’s refusal to grant a permit to take skipjack tuna. The applicant submitted that Australian fishers take only ‘an infinitesimal quantity’ of the abundant resource20 and that ‘there was no evidence . . . to suggest there was a threat of serious environmental damage’. The principal argument put forward by AFMA to justify its decision was the lack of knowledge of the impact of fishing for skipjack tuna. The AAT did not consider that there was a threat of ‘serious or irreversible environmental damage’, but what the evidence of one scientist did establish was that while ‘the necessary scientific evidence as to the state of the fish stocks . . . remains . . . uncertain, there is, accordingly, a risk of serious environmental damage’ by permitting further fishing. The AAT found that the non-issuing of the permits was ‘a step which pursues’ the precautionary objective and thus the refusal to grant the permits ‘was a lawful pursuit’ of the objective.21 The AAT decision was unsuccessfully appealed to the Federal Court of Australia. The Court did not disturb the AAT’s conclusion that uncertainty alone can meet the threshold.22 It is important to note that in many environmental management contexts a sufficient threat may exist, yet this remains unknown due to an absence of adequate data. In such situations, it would seem that the precautionary principle is not triggered in Australia. However, the decision in AJKA v. AFMA appears to provide strong, if indirect, support for the conclusion that the high threshold in the IGAE can be met by the presentation of nonrigorous evidence of uncertainty. Indeed, in the fisheries management context, it would be relatively easy to argue that areas of uncertainty exist in relation to every commercially targeted species – such as impacts on predator species, levels of bycatch and levels of fishing effort. In this sense, the decision in AJKA v. AFMA appears to allow for ‘uncertainty’, as opposed to a specific ‘threat’, to provide a lawful justification for precautionary responses. Although such reasoning is consistent with precautionary philosophy, it appears to be out of step with the legislative formulation of the principle. The second group of cases illustrate a different approach. Here the cases reveal the possibility of enforcing the principle’s threshold test in the context of appeals against refusal to grant development consent. In Tuna Boat Owners Association of SA v. Development Assessment Commission & Conservation Council of SA,23 Doyle CJ of the Supreme Court of South Australia noted that there could be no ‘hard and fast rules’ about what is required by the precautionary principle,24 but cautioned that ‘one must take care not to drift’ into a position of refusing to grant consent to

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a proposed development ‘because all of the consequences that might flow from it are not known’.25 Similarly, in Histpark P/L v. Maroochy Shire Council,26 Robertson J of the Queensland Planning and Environment Court confirmed that ‘the precautionary principle is not concerned with “bare possibilities” of serious or irreversible environmental damage’27 and observed that a proponent of an activity which has been denied approval is not required to prove ‘the complete absence of any likely future environmental harm’ when seeking approval.28 This suggests the need for credible evidence that the threshold has been reached to warrant refusal of development consent. The applicant in Dixon v. AFMA29 argued that the principle was invalid because the threshold for its operation had not been met. Although the AAT rejected this argument, it stated that the contention that AFMA cannot exercise the principle if the threshold test is not met ‘has merit’ if the measures undertaken are not in the pursuit of other legislative objectives.30 However, there was nothing to prevent AFMA from exercising the principle if the threshold is not met, as long as it is also acting properly in pursuit of other mandatory objectives. Thus, AFMA could adopt a precautionary standard until such time as it was established that its removal would not cause a risk of serious or irreversible damage.31 However, in such a case, it would be valid for AFMA to retain the standard if this would be in pursuit of other mandatory objectives. It is to be noted that the Tribunal indicated that it might be that an AFMA decision will be invalid if it is properly in pursuit of the precautionary principle but gives that objective ‘undue paramountcy’ over other mandatory objectives.32 In Commercial Crash Repairs P/L v. Corporation of the City of Adelaide,33 the South Australian Environment Resources and Development Court [SAERDC] considered whether the principle should be applied with respect to an application to develop a car spray painting workshop in a suburban area. The Council had refused development consent but the Court decided that the principle should not be applied because no evidence was presented about the existence of a threat of ‘serious or irreversible environmental damage’ arising from the proposed use.34 The evidence indicated that the development would comply with recognized emission standards.35 As such, the Court concluded that ‘the risk of unacceptable emissions is low and that the caution advocated in the precautionary principles is not warranted’,36 and thus granted provisional development consent. In Aldekerk P/L v. City of Port Adelaide Enfield and Environment Protection Authority,37 the SAERDC needed to determine whether to allow an appeal against the refusal to grant development consent for the construction within a funeral home of a furnace for the cremation of human remains.


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The City of Port Adelaide Enfield refused the application due to evidence that although the furnace would in normal operation meet emission regulations, ‘abnormal’ operations could occur due to mechanical breakdowns, possibly resulting in the emission of ‘dark smoke and excessive odour’. The Court acknowledged the need to be ‘cautious and careful’ but also declared that it had ‘some reservations as to whether this is a proper case for the application of the precautionary principle’.38 The scientific opinions expressed were that the likely emissions would not constitute an environmental threat.39 The Court approved the development application after making the following observation: [T]here is insufficient scientific uncertainty . . . to render this a case in which the precautionary principle might properly be used . . . The precautionary principle should only be applied . . . in those cases where there is genuine uncertainty or ignorance on relevant scientific matters and there is a risk of substantial impairment to the environment. It cannot be used to prop up a decision that is unsupported by tenable evidence.40

Although the above decisions reveal that the AAT and merits review environmental courts will afford agencies a degree of flexibility in how they decide to implement precaution when fulfilling their legislative functions, they nevertheless expect that the principle’s threshold will be met. The Federal Court decision in AJKA v. AFMA is surprising because it implicitly equates ‘uncertainty’ with the threshold set in the IGAE. Its willingness to do so seemed to be in recognition of the complexity of the tasks AFMA faces when managing a large multiple-use environment, and the absence of counsel submissions on this point during the court case. Although the Federal Court decision may be questionable, its relevance to other environmental management contexts may be limited due to the administrative culture developing in the fisheries management context and the uncertainties that abound in the marine environment. For example, the Federal Court’s reasoning may not be easily applied to smaller-scale development applications as in Aldekerk. Nevertheless, these decisions provide support for the proposition that a test for determination of the threshold is needed, although it need not be highly rigid and may differ depending on the environmental management context.

IS THE THRESHOLD TEST ENFORCEABLE? The attention that has been given to the question of whether the threshold test can be relied on when challenging an administrative decision has focused on challenges to a department or agency’s failure to invoke the

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principle. These challenges have relied on the relevant consideration or unreasonableness grounds of review. These grounds are difficult to establish. First, the courts have enabled a duty (where it exists) to consider the principle when making decisions under legislation to be satisfied easily.41 This is perhaps influenced by the absence of consequences that would flow from a mere failure to consider the principle. That is, it would be unlikely in most circumstances that a failure to consider the principle would result in the repository of a discretionary power reaching a different decision. Secondly, the unreasonableness ground is difficult to establish for the reason that there needs to be ‘something overwhelming’42 about the decision for it to be legally flawed. However, we are here considering whether a legal challenge can be made to a decision for the reason that it was too precautionary. As such, another ground of judicial review becomes arguable: improper (or unauthorized) purpose. Although in most cases an improper purpose would also be an irrelevant consideration, this is not always the case. The improper purpose ground is narrower. Under this ground, an exercise of power will be invalid if it was exercised for a purpose other than that contemplated by the legislature.43 Although the content of the principle is flexible and can lead to a range of precautionary outcomes, the expression of its threshold utilizes relatively clear language, and thus the threshold for its operation can be determined. If it were parliament’s intention that the principle be allowed to be pursued in situations of uncertainty that do not amount to a significant threat, then arguably the legislation would have been so worded. As such, it would seem open to argue that, if the legislative threshold for the operation of the principle were not met in the circumstances of a case, then it would be an improper exercise of power to base a decision on the principle in the absence of additional legislative support. The Australian litigation reviewed above shows that merits review tribunals and courts look for the threshold test to be met and indeed there have been cases that have overturned precautionary decisions because of insufficient evidence of threat. Although no clear rule can be discerned from the cases and we are still yet to see a full judicial review challenge in Australia of the use of precaution in an environmental decision, these merits review cases show us that there is an acceptance that some threshold is appropriate for precautionary decision making, and that it must be established. Courts in New Zealand and England have also required the presentation of evidence that the threshold was established.44 This is consistent with academic commentary, including that by Justice Stein (2000, p. 21) in an extra-curial piece when he noted that the precautionary principle ‘does not prohibit an activity until the science is clear’. What is, however, also clear from the cases is that the various tribunals and merits review courts


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have differed with regard to what level of evidence satisfies the threshold test. Their variance is most likely attributable to the context of the decision at hand – whether it is a decision on natural resource management or on a small-scale planning matter. This reasoning is likely to inform any future judicial review cases.

THE THRESHOLD TEST IN THE CONTEXT OF OTHER LEGISLATIVE OBJECTIVES If a decision is considered to be impermissibly precautionary by reason of it being made without the threshold being established, can an authority find support for its decision in other statutory objectives? In other words, can an administrator adopt a risk-averse approach notwithstanding that the principle does not, as expressed in the IGAE, apply to low-level threats? In relation to AFMA, in addition to its precautionary principle objective, it has broader ESD objectives as well as various other specific objectives such as having regard to the impact of fishing activities on ‘non-target species’ and the ‘long term sustainability of the marine environment’.45 These specific directions support AFMA taking strong decisions to, for example, reduce bycatch. Some decisions can be based on these objectives without resting on the precautionary principle for justification. As such, a ‘precautionary’ decision may be a matter appropriately within legislatively conferred discretion, and the correct statutory construction of the principle may not be pivotal for decisional validity. A precautionary decision could, however, be challenged where, although it is not disputed that the decision was properly in pursuit of the principle, the decision gave the principle undue paramountcy in the light of other legislative objectives. This would arise, for example, where competing economic or, possibly, social objectives are given insufficient weight, especially when precaution was applied particularly strictly. In the fisheries context, where the precautionary objective is located alongside an ‘economic efficiency’ objective, a management decision to, for example, close a fishery due to concern over stock levels might have failed to accord sufficient weight to short-term economic consequences of the decision. A court’s willingness to find the threshold enforceable could also be influenced by the way in which the precautionary duty is expressed. For example, the ‘imperative nature’46 of the section 3(1) obligations in the Fisheries Management Act 1991 (Cth) requires a positive act to pursue precaution. This may lead to the determination of a restrictive threshold, particularly as other objectives must also be pursued.

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APPLYING PRECAUTION WHEN NOT ALL UP TO DATE INFORMATION IS CONSIDERED Two decisions of the New Zealand High Court reveal another way in which ‘precautionary’ decisions can be challenged. This is when a decision has been made ostensibly in support of the principle in circumstances where not all readily available information was considered or where there was a misunderstanding of the scientific evidence. The Fisheries Act 1996 (NZ) generally mirrors the IGAE version of the principle but also adds an instruction in section 10(a) that decisions ‘should be based on the best available information’. In the first case, Northern Inshore Fisheries Company Limited v. Minister of Fisheries,47 the Minister of Fisheries made a decision to close inshore set netting to protect the highly vulnerable Hector Dolphin. The Minister received advice which reported that the Hector Dolphin population ‘may eventually decline to extinction if the by-catch rate from fishing is more than one dolphin in the five year period’.48 It was also believed that there had been three fishing-related deaths of Hector Dolphins in the previous six months, thus raising the fear that 15 years’ worth of ‘acceptable’ bycatch had been reached.49 The Minister stated that in closing the fishery he ‘adopted a precautionary approach’.50 The fishing industry submitted in its appeal against the decision that it had been based on a mistake of fact with respect to the extinction threshold. It presented evidence that the determination of the maximum allowable level of fishing-related mortality [MALFIRM] of one dolphin death in five years had incorrectly been assumed to mean that exceeding this figure would lead to the likely extinction of the species. It argued that the calculation predicted the probability of survival, not extinction, of the species.51 Ronald Young J accepted this interpretation and concluded that the Minister made a mistake of fact by not using the MALFIRM calculation as intended to predict a level at which it is probable that the population will increase.52 His Honour considered that section 10(a) ‘is a clear statement about the quality of the information to be available to decision makers’53 and set aside the Minister’s ‘precautionary’ measure to protect the dolphin. The second case, Squid Fishery Management Company Limited v. Minister of Fisheries,54 concerned an appeal against a decision to close the squid fishery due to mortality of sea lions. A MALFIRM calculation was used whereby once squid fishing operations had killed 70 sea lions, the fishery would be closed. The key issue was how to determine whether 70 sea lions had in fact been killed during the fishing season. The management plan provided that a default mortality figure of 9.4 per cent of all fishing tows would be applied if observer coverage fell below 20 per cent of all fishing vessels.


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The determination of actual sea lion mortality was complicated by the use in some fishing nets of devices designed to enable sea lions to escape. Sea lion excluder devices (SLEDs) were fitted to a number of vessels, including all vessels on which observers were placed. The fishing industry unsuccessfully sought a reduction in the default figure to take account of the fact that some sea lions would escape unharmed. The Ministry submitted that the principal reason why the rate was not discounted was ‘the absence of scientific or other information about the effectiveness of SLEDs’.55 However, there was available evidence, which did not reach the Minister, that approximately 90 per cent of sea lions that entered nets were able to escape through the SLEDs, although approximately 20–40 per cent were thought to suffer lifethreatening injuries in the process of escaping.56 Nevertheless, it was assumed that a number of sea lions escaped without such injuries. The Court criticized the purported reliance on precaution in the circumstances. After reading the advice presented to the Minister, Ronald Young J noted that it could easily be assumed that little or nothing was known about what happened to sea lions escaping from SLEDs. This is simply not true. . . . [P]retending there were no . . . results [of ejection and survival rates] is misleading.57

The Court concluded that the Minister received ‘misleading and inaccurate’58 advice that was not up to date59 and thus the Minister ‘was not in a position to make an informed decision’, as required by section 10, to set the default rate and had thereby made an error of law.60 Another complication was that during the fishing period only two sea lion deaths had been observed. This actual observed death rate extrapolated to a 1.3 per cent death rate for the fishery, substantially below the default rate. Unfortunately, the Minister was not informed of the actual observed in-season mortality rate.61 The Court concluded that an error of law occurred because the Minister should have considered the actual observed in-season death rate because it was ‘relevant available information about sea lion deaths which seemed significantly at odds with the predicted death rates. . . . The Ministry had shut its eyes to what was happening, or at least it refused to reconsider and analyse what was happening.’62 These two cases show that ‘precautionary’ decisions can be set aside in judicial review actions on the basis of misconstruction of statutory duties, in particular, failure to take into account relevant considerations and, possibly, unreasonableness. In both of these cases the Court held that there had been a failure to obtain accurate and up to date information as required by the specific legislative precautionary guides. Although the Act expressly adopts the core of precautionary philosophy by requiring that decisions ‘be based on the best available information’, this instruction is useful with respect to decisions to allow future activities but it can actually work

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against the principle with respect to the principle’s second application – whether to prohibit or restrict an existing activity before there is conclusive proof of harm. As such, the ‘precautionary’ best information requirement in the Act reduces the ability to make precautionary decisions because decisions to close fisheries due to concerns about unacceptable impact on threatened bycatch species cannot be made until all presently available relevant scientific information is considered and correctly understood. The remarkable aspect of these cases is that they demonstrate that administrators cannot claim uncertainty as the basis for their decisions when in fact relevant information is available or when there was a material factual error that was pivotal to the decision. As such, the manner in which departmental advice is phrased and passed on to final decision makers can be crucial to the legality of decisions. The cases reviewed here show that there are four possible ways to challenge a precautionary decision. The first method would be to show that the threshold had not been met (in cases where the legislation incorporates a threshold in a manner similar to that contained in the IGAE), providing that in the circumstances there is no other legislative support for the decision. The second method would be to show that the principle was given undue paramountcy in the context of other legislative objectives (or given undue weight in circumstances where it is not specifically included in the relevant piece of legislation). The third and fourth methods (where legislation additionally provides that decisions need to be based on the best available information) would be to show either that not all up to date information was considered or that there was reliance on inaccurate evidence.

CONCLUSION The increased reliance on the precautionary principle by Australian environmental management agencies has resulted in a change in litigation concerning the principle – from opponents to decisions arguing that government departments failed to act with requisite caution to opponents arguing that government departments impermissibly acted with too much caution. Although to date these challenges have almost exclusively been merits review cases, it is likely that judicial review challenges will also be made. Departments that have developed a culture of acting with precaution are particularly susceptible to challenge, especially if they do not have clear legislative mandates to make precautionary decisions. Although application of the principle is reviewable by courts, opponents to decisions will be faced with onerous evidentiary burdens to invalidate precautionary decisions. Where a development application is refused, the


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burden necessarily falls on the proponent to show why the development should proceed and that the agency applied precaution in circumstances where it either was not triggered or gave the principle undue paramountcy at the expense of other legislative objectives. Further, courts are likely to continue to give environmental management agencies a degree of flexibility in making decisions. Infusion of policy considerations will also be apparent, such that courts might be inclined to continue to adopt a ‘commonsense’ approach to the principle rather than a strict textual interpretation of the threshold. However, the establishment of the threshold may be an achievable task with respect to small discrete project development applications as opposed to large-scale natural resource exploitation decisions, such as in the fisheries management context. Although the principle is not a rigid rule and there may be a range of permissible precautionary outcomes in any given situation, the threshold expressed in Australian legislation is relatively precise and it is an essential component of the principle. As such, some legal meaning must be ascribed to it so that the principle cannot be a complete shield for public decision makers and a blanket excuse for arbitrary action in the infinite number of environmental issues where uncertainty exists (see Fisher 2001, p. 324). Notwithstanding the failure hitherto of courts to determine ‘bright line’criteria for the application of the precautionary principle, some operational content in particular environmental management contexts could be determined in judicial review challenges, especially in relation to its threshold, and precautionary decisions could be invalidated as a result of such litigation. It is necessary to revise legislative adoptions of the principle to minimize the prospect of such litigation and to provide more guidance for environmental decision makers faced with ambiguous and possibly, inconsistent statutory environmental management obligations. There is now a pressing need in Australia for legislative adoption of a more useful definition of the principle’s threshold, in a manner that is more consistent with precautionary philosophy.

NOTES 1. 2. 3. 4. 5.

For example, the Fisheries Management Act 1991 (Cth) was so amended in 1997. For example, most State fisheries legislation in Australia does not expressly include the principle. Justice v. Australian Fisheries Management Authority [2001] AATA 49. For example, Bass Strait Scallop Central Zone Fishery Strategic Assessment Report (2003) under Part 10 of the Environment Protection and Biodiversity Conservation Act 1999 (Cth). For example, 2000 Commonwealth ban on commercial tuna fishing permit holders to land shark fins unattached to the body of sharks. See Hon Warren Truss, Minister for

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6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38. 39. 40. 41. 42. 43. 44. 45. 46. 47. 48. 49. 50. 51.

Challenges involved in implementing the precautionary principle Agriculture, Fisheries and Forestry, ‘Federal Government to ban shark finning’, Media Release, 5 October 2000, AFFA00/181WT. For example, Northern Inshore Fisheries Company Limited v. Minister of Fisheries CP 235/01 HC Wellington, Ronald Young J 4/3/2002 (unreported). AJKA Pty Ltd v. Australian Fisheries Management Authority [2001] AATA 258. Leatch v. Director-General of National Parks & Wildlife and Shoalhaven City Council (1993) 81 LGERA 270. Section 30(c) Oceans Act 1996 (Canada). Fisheries Management Act 1991 (Cth). Section 391 Environment Protection and Biodiversity Conservation Act 1999 (Cth). See for example s 7(1) Living Marine Resources Management Act 1995 (Tas). See for example s 10 Fisheries Act 1996 (NZ). See for example Bannister Quest v. Australian Fisheries Management Authority (1997) 77 FCR 503. Section 3(2)(c) Fisheries Management Act 1991 (Cth) (with respect to straddling and highly migratory stocks). This phraseology is drawn from Bates (2002, p. 134). [2001] AATA 49. Ibid, para. 71. [2001] AATA 258. Ibid, para. 61. Ibid, para. 86. AJKA P/L v. AFMA [2003] FCA 248. [2000] SASC 238. Ibid, para. 30. Ibid, para. 35. [2001] QPEC 059. Ibid, para. 21. Ibid. [2000] AATA 442. Ibid, paras 120–121. [2000] AATA 442, para. 105. Ibid, para. 182. [2000] SAERDC 83. Ibid, para. 43. Ibid. Ibid. [2000] SAERDC 47. Ibid, para. 22. Ibid, para. 25. Ibid. See for example Friends of Hinchinbrook Society Inc v. Minister for the Environment (1997) 142 ALR 632. Associated Provincial Picture Houses Ltd v. Wednesbury Corporation [1948] 1 KB 223 at 230. Section 5(2)(c) Administrative Decisions (Judicial Review) Act 1977 (Cth). R v. Secretary of State for Trade and Industry ex parte Duddridge and Others, Queens Bench Division [1995] Env LR 151 and Greenpeace New Zealand Inc v. Minister of Fisheries, unreported, High Court of New Zealand, CP 492/93, 27 November 1995. Section 3(1)(b) Fisheries Management Act 1991 (Cth). Bannister Quest v. Australian Fisheries Management Authority (1997) 77 FCR 503. CP 235/01 HC Wellington, Ronald Young J 4/3/2002 (unreported). Ibid, para. 20. Ibid, paras 35 and 59. Ibid, para. 40. CP 235/01 HC Wellington, Ronald Young J 4/3/2002 (unreported), paras 54–55.

The threshold test of the precautionary principle in Australian courts 52. 53. 54. 55. 56. 57. 58. 59. 60. 61. 62.

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Ibid, para. 58. Ibid, paras 74–75. CP 20/03, HC Wellington, Ronald Young J, 11/4/2003 (unreported). Ibid, para. 24. Ibid, para. 25. Ibid, para. 29. Ibid, para. 29. Ibid, para. 31. Ibid, para. 35. Ibid, para. 40. Ibid, para. 40.

REFERENCES Bates, G. (2002), Environmental Law in Australia, 5th edn, Sydney: Butterworths. Finn, C. (2002), ‘The justiciability of administrative decisions: a redundant concept?’, Federal Law Review, 30 (2), 239–59. Fisher, E. (1999), ‘The precautionary principle as a legal standard for public decision-making: the role of judicial and merits review in ensuring reasoned deliberation’, in R. Harding and E. Fisher (eds), Perspectives on the Precautionary Principle, Sydney: Federation Press, pp. 83–98. Fisher, E. (2001), ‘Is the precautionary principle justiciable?’, Journal of Environmental Law, 13 (3), 315–34. Fisher, E. (2002), ‘Precaution, precaution everywhere: developing a “common understanding” of the precautionary principle in the European Community’, Maastricht Journal of European and Comparative Law, 9 (1), 7–28. Gullett, W. (1997), ‘Environmental protection and the “precautionary principle”: a response to scientific uncertainty in environmental management’, Environmental and Planning Law Journal, 14 (1), 52–69. Gullett, W. (2000), ‘The precautionary principle in Australia: policy, law and potential precautionary EIAs’, Risk: Health, Safety and Environment, 11 (2), 93–124. Gullett, W., C. Paterson and E. Fisher (2001), ‘Substantive precautionary decisionmaking: the Australian Fisheries Management Authority’s “lawful pursuit” of the precautionary principle’, Australasian Journal of Natural Resources Law and Policy, 7 (2), 95–139. Stein, P.L. (2000), ‘Are decision-makers too cautious with the precautionary principle?’, Environmental and Planning Law Journal, 17 (1), 3–23.

10. Precautionary only in name? Tensions between precaution and risk assessment in the Australian GMO regulatory framework* Jacqueline Peel INTRODUCTION More than a decade on from the enunciation of ‘Principle 15’ in the Rio Declaration,1 debate regarding the precautionary principle is shifting from issues of scope and definition to questions of implementation. Notions of precaution now advanced – including that in this chapter – emphasize the role of the principle as a broad framework for decision making, directed to anticipating possible adverse effects that, although scientific uncertainty persists, are cause for reasonable concern. In Australia, as elsewhere in the world, support is growing for a concept of precaution that focuses on the responsiveness of health and environmental decision-making processes to scientific uncertainty (Fisher and Harding, 2001). This represents a departure from more conventional understandings of precaution, which have seen its operation as dependent upon ‘threshold’ findings of some minimal level of risk, variously expressed as a ‘non-negligible threat of harm’ (Cameron and Abouchar, 1996, p. 44) or a risk of ‘reasonable scientific plausibility’ (de Sadeleer, 2002, p. 160). Moving from thresholds of risk as a basis for precautionary measures, to an approach concentrating on the process by which determinations of risk are reached in circumstances of scientific uncertainty, highlights potential tensions between the implementation of precaution and orthodox ‘science-based’ decision-making processes of risk assessment. In particular, I argue that a focus on the decision-making process required for implementation of precaution reveals the importance of exposing risk assessment to a broader range of views *

A more detailed version of the argument in this chapter is published in Peel, J. (2005), The Precautionary Principle in Practice: Scientific Uncertainty and Environmental Decisionmaking, Sydney: Federation Press. This chapter is published by permission.

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Precautionary only in name?

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than the traditional inputs provided by scientists and regulatory ‘experts’. Opening up risk assessment in this way can ensure a comprehensive consideration of the issues of uncertainty that frequently arise in the identification and evaluation of health and environmental risks associated with new technologies. This is especially so where the uncertainties at issue reflect the current limitations of scientific knowledge to provide, in every case, reliable, long-term information about harm-generating processes and/or their impact on receiving ecosystems. Ideally then, implementation of the precautionary principle alongside risk assessment will require attention to the issue of how regulatory frameworks incorporate broader input – most usually from the general public – into processes for the selection and assessment of health and environmental risks. In Australia, however, inclusion of precautionary concepts in regulatory frameworks concerned with issues of risk has been relatively haphazard, with a common approach being to add precaution to the objects section of legislation that otherwise contains standard ‘science-based’ decision-making processes (Gullett, 2000). The new Australian risk regulatory scheme governing ‘dealings’ with genetically modified organisms (GMOs) provides a case study of this kind of ad hoc approach to implementation of the precautionary principle, and the difficulties it generates when decision makers then attempt to reconcile precaution with the other elements of the decision-making framework. The Federal Gene Technology Act 2000 (GTA) at the heart of the GMO regulatory scheme contains requirements for the scheme’s ‘Gene Technology Regulator’ (Regulator) to undertake scientific risk assessment of GMO dealings, followed by a process of risk management, which together are designed to achieve the Act’s object of protecting the health and safety of people and protecting the environment. On to this framework has been grafted a Rio Declaration formulation of the precautionary principle that was introduced into the legislation as a last-minute measure to secure political support for its passage through the Federal Parliament. Precaution thus appears in the GTA only in the equivocal role of one element of ‘a regulatory framework’ that is to be used to ‘achieve’ the object of the Act. While this reference to precaution in the legislation may create expectations on the part of the public, and indeed the Regulator herself, that the GMO risk assessment process should be undertaken in a ‘precautionary’ (or at least a ‘cautious’) fashion (OGTR, 2005, pp. 15–16), I argue that other elements of the scheme work against the implementation of a truly ‘precautionary process’ that makes comprehensive provision for the consideration of scientific uncertainty. The chapter begins by elaborating my preferred notion of precaution as a concept concerned with the process of risk assessment, explaining the necessity for risk assessment to be open to a ‘broader’ range of inputs in

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order to allow for a ‘comprehensive’ consideration of scientific uncertainty associated with new technologies like GMOs. The following section of the chapter describes the Australian GMO regulatory framework. This discussion focuses on the aspects of the risk assessment process operating under the GTA that tend to work against its capacity to be ‘precautionary’ in the manner and extent to which it takes account of issues of uncertainty. Two particular elements of the current Australian GMO regulatory framework are analysed in this regard. First, the limited scope for the involvement in the initial phase of risk assessment of viewpoints beyond those of scientists and regulatory experts because of a provision in the legislation that makes public consultation on the application dependent upon a discretionary finding by the Regulator that the dealing concerned ‘may pose significant risks’ to health or the environment. Second, the narrow ambit of the Regulator’s risk assessment mandate under the Act, which favours scientific and ‘expert’ ways of conceptualizing the risks and uncertainties associated with GMOs, over other risk perceptions. The discussion of these two elements of the Australian GMO regulatory framework serves to highlight an issue of wider significance, namely the need for careful design of decisionmaking frameworks within which precaution is implemented if the principle is to be given effect in substance and not merely in name.

PROCESSES OF PRECAUTIONARY RISK ASSESSMENT The expression of the precautionary principle most prevalent in Australian environmental legislation (including the GTA) is based on the Rio Declaration formula that ‘where there are threats of serious or irreversible environmental damage, a lack of full scientific certainty should not be used as a reason for postponing cost-effective measures to prevent environmental degradation’ (Gullett, 2000).2 This formulation of the precautionary principle is often interpreted by Australian decision makers and courts to require the satisfaction of a ‘threshold’ finding of ‘threats of serious or irreversible environmental damage’ before the principle becomes operational.3 However, applied rigidly, such an approach limits precautionary measures to a narrow range of circumstances ‘where there is knowledge that a dangerous outcome is possible (or probable) rather than where there is uncertainty or only some indication that environmental harm may occur’ (Gullett et al., 2001, p. 130). In this way, risks of harm for which scientific knowledge is poor, absent or difficult to verify in the face of ecosystem complexity may evade the precautionary principle net. The problems of a ‘threshold’ approach in dealing with complex and intractable forms of


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uncertainty have led to recognition of the need for a more flexible concept of precaution that sees the principle, not as a ‘hard and fast rule’, but as a guide to processes of decision making that are designed to accommodate scientific uncertainty. The success of implementation of precaution in this sense is judged by ‘how adequately and meaningfully scientific uncertainty is taken into account in the decision-making process’ (Fisher, 2005, p. 19). Dealing with Uncertainty in Risk Assessment Processes of risk assessment, involving systematic procedures for evaluating scientific information about potential risks,4 have traditionally been oriented towards the prevention of harm to human health and safety from known and well-characterized hazards (Sullivan and Hunt, 1999). As techniques of risk assessment have been extended beyond the domains of engineering and toxicology to the environmental field they have increasingly encountered issues of uncertainty. Given the open-ended nature of ecosystems, the complexity of ecological processes and the more limited nature of scientific knowledge concerning many environmental issues compared with disease risks, the issues of uncertainty that arise will frequently be intractable (Santillo et al., 1998), that is, they ‘cannot be reduced by more effort such as more data or more accurate data’ (OGTR, 2005, p. 101). Where such issues of uncertainty are associated with the potential effects of technologies like GMOs, the ‘precautionary’ capacity of the risk assessment process used to evaluate those effects can be determined by the manner and extent to which the process responds to scientific uncertainty. The ways in which risk assessment can respond to issues of scientific uncertainty is a topic of growing prominence in the risk literature. Klinke and Renn (2002) describe the two broad approaches that have emerged for dealing with uncertainty in the evaluation and management of risk, which they label ‘risk-based’, and ‘precaution-based’. In the ‘risk-based’ approach, the solution to problems of uncertainty is seen to lie in the honing of analytical tools for characterizing uncertainty, modelling variability and expressing levels of uncertainty in an unambiguous fashion. Risk assessment, according to this approach, still relies on the evaluation of scientific material to produce risk estimates that combine the probability of occurrence of hazards with the predicted magnitude of harms. However, better knowledge of the components of uncertainty, and improved techniques for managing it, allow more reliable assessments that effectively contain problems of uncertainty within the process of ‘scientific’ risk assessment. The alternative ‘precaution-based’ approach takes the position that the management of some uncertainties currently remains beyond existing technical capacities so that protective measures are required to provide

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insurance against ‘unexpected’ events. The ‘precaution-based’ approach does not reject the need for scientific input into risk assessment, but it is acknowledged that the intractable nature of many of the uncertainties identified will mean that scientific risk evaluation alone cannot provide a definitive basis for determining the significance of possible risks. Instead, policy decisions or value trade-offs are needed to determine how much uncertainty society is prepared to accept in the light of the potential benefits of a proposal. The extent to which a ‘risk-based’ or ‘precautionbased’ approach will be appropriate in any particular risk assessment setting as a means for taking account of uncertainties will depend upon an appraisal of the features of the hazards at issue, in particular, the nature of the uncertainties that arise (Stirling and van Zwanenberg, 2003). Need for a ‘Broader’ Risk Assessment Process Questions of scientific uncertainty have been seen as especially pertinent in the GMO context because of the relatively short time period of use of the technology and unresolved issues over the long-term health and environmental effects of GMOs released into ecosystems, such as GM crops (NRC, 2002). The main concerns relate to uncertainties that are difficult to resolve, at least over the short term, because they arise from incomplete scientific knowledge regarding some risks, or the inability to characterize other risks fully. In these circumstances, dealing with uncertainty will rarely be a matter of simply honing analytical tools for characterizing, modelling or expressing uncertainty. Rather, addressing these uncertainties will involve value judgments about what unknowns society is prepared to tolerate (or put another way, what evidence society is prepared to accept as adequate ‘proof’ of safety in the circumstances) (Klinke and Renn, 2002). These judgements, like all ‘value’ determinations, will be affected by socio-cultural factors, producing divergent views between those who are ‘risk-averse’ and those who are ‘risk-tolerant’. Differences can also be expected to emerge on these questions between ‘experts’ and ‘lay people’, given the different ways in which individuals from each category have been found to evaluate risk (Slovic, 2000). It is in this context that the involvement of a ‘broader’ range of views in the risk assessment process becomes a crucial tool for ensuring that the process takes account of scientific uncertainty in as comprehensive a fashion as possible. A ‘comprehensive’ assessment here connotes one that will take the greatest possible cognisance of issues of uncertainty relating not just to the deficiencies of existing scientific evidence, but also to what may lie outside of its bounds (Fisk, 1998). There are two main reasons that can be advanced in support of opening up risk assessment as a means of


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ensuring greater responsiveness of the process to issues of uncertainty, particularly in its more complex and intractable forms. First, inviting a broader range of perspectives into the risk assessment process will tend to offset the tendency of ‘experts’ to overestimate the predictive value of current scientific knowledge and so downplay remaining uncertainties. This tendency on the part of experts arises because of long familiarity with scientific methodologies, which give prominence to tractable uncertainties but tend to render other, more intractable forms of uncertainty invisible to practitioners working within a given theory’s boundaries (Wynne, 1992). An important part of public responses to GMOs, on the other hand, appears to be ‘a combined ethical-intellectual judgment of the exaggerated claims being made by scientific experts about the intellectual power of the scientific risk knowledge’ (Wynne, 2001, p. 447). This suggests that ‘outside’ involvement in the process used to evaluate scientific knowledge about risk (and associated uncertainties) can provide an effective mechanism for drawing attention to the potential limits of scientific knowledge regarding GMOs, and the contested nature of judgements about what counts as adequate ‘proof’ of safety where definitive scientific evidence is lacking. The second reason for embracing a ‘broader’ process relates to the consequences of restricting participation in risk assessment to scientific assessors and regulatory experts in circumstances where intractable issues of uncertainty arise. Limitations on the direct involvement of the public in the risk assessment process are often justified in accordance with the traditional notion that a ‘science-based’ evaluation of risk will ensure the ‘objectivity’ of resulting risk estimates (Sullivan and Hunt, 1999). However, where the relevant issues of uncertainty extend beyond technical matters to encompass questions of what levels of uncertainty are acceptable, there is little justification for privileging scientific judgements on these questions, especially as it is not only experts who will have to bear the consequences of these decisions (Levidow and Carr, 1997). In pluralistic societies, leaving value choices to one group runs counter to the general assumption that decisions on questions of social value will be made taking into consideration the values of all in the community (Fisher, 1999). Thus in cases where complex or intractable forms of uncertainty arise, I argue that a ‘precautionary’ process of risk assessment should allow for more than the views of scientists and regulatory experts to influence the identification and evaluation of the health and environmental risks associated with use of a particular technology. Incorporation of a broader range of views on risk and uncertainty issues may not be accommodated by conventional models of risk assessment, which designate the process as a ‘scientific’ domain in line with the view that this will promote objectivity

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and reliability. Newer risk regulatory regimes may well make provision (sometimes extensive) for public consultation and discussion of ‘ethical’ issues, although this generally does not play a role in risk evaluation because of the separation of issues of ‘risk’ (seen as a matter for expert assessors) from those of ‘ethics’ (Levidow and Carr, 1997). Structuring risk assessment in this way assumes that dealing with any uncertainties surrounding risks is also a matter for science that does not implicate value judgements. However, where the uncertainties at issue raise questions over the capacity of science to be able to know reliably what the risks are (or what they might be over the longer term) exclusively ‘scientific’ processes for managing those uncertainties will not provide a comprehensive, nor (according to the conception of precaution advanced in this chapter) a ‘precautionary’ response. It is against this notion of precaution – as a principle concerned with the manner and extent to which uncertainty is taken into account in the decision-making process – that I shall evaluate the Australian GMO regulatory framework.

AUSTRALIAN GMO REGULATORY FRAMEWORK Uncertainties over the risks posed by GMOs, generating public concern and potential resistance to the commercialization of gene technology, were an important driver in the development of a new GMO regulatory framework in Australia (Senate Community Affairs Committee, 2000). The process that led to the drafting of the Federal Gene Technology Bill involved multiple rounds of consultation between Federal and State governments, between regulatory agencies within the Federal government, with ‘stakeholder’ groups and with the general public (OGTR, 2005, pp. 81–82). The agreement that emerged from these consultations was that the new scheme was to focus exclusively on the evaluation of risks to health and safety and the environment . . . to prevent economic considerations (e.g. cost-benefit analyses, market access and agricultural trade implications) from compromising the regulatory system’s focus upon the scientific evaluation of risks and the protection of human health and safety and the environment (OGTR, 2005, p. 13).

As a result, the central object of the legislation is ‘to protect the health and safety of people and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with GMOs’ (GTA, s.3). The decision-making framework that underlies this object is one of combined ‘risk assessment’ and ‘risk management’ for dealings that will involve the release of a GMO


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into the environment (GTA, s.51). Responsibility for undertaking the risk assessment and risk management process is delegated under the scheme to an independent statutory officer, the Regulator, who produces a ‘risk assessment and risk management plan’ (RARMP) for each GMO environmental release application (GTA, s.50). This document informs the Regulator’s decision on the licensing of a GMO for environmental release, which licence cannot be issued unless the Regulator is satisfied that any risks posed by the dealing can be managed in such a way as to protect human health and safety, and the environment (GTA, s.56). Precaution in the GTA The role played by precaution in the risk assessment and risk management framework established by the GTA is an uncertain one, reflecting the somewhat ad hoc manner of incorporation of precaution into the Act. During initial negotiations regarding the legislation, the possibility of including a reference to the precautionary principle was considered by Federal and State governments, but ultimately rejected on the basis that ‘the risk assessment and risk management approach contained in the Bill embodied an appropriate precautionary approach without being directly stated’ (Senate Community Affairs Committee, 2000, p. 40). When the Bill reached the Senate of the Federal Parliament it was referred to a Senate Committee inquiry, which received submissions from governments and the public, and heard presentations from a variety of witnesses. One of the recommendations of the Committee was that a ‘precautionary approach’ should be adopted in the regulation of GMOs, which would be ‘underpinned in the Bill if the precautionary principle appeared as one of the objects’, although the Committee did not support ‘the precautionary principle being made a specific test in the licensing process’ (Senate Community Affairs Committee, 2000, p. 45). Ultimately, precautionary language, in the sense of repetition of the Rio Declaration formula of the precautionary principle,5 was included in the final form of the legislation, but not in the objects section of the GTA. Instead precautionary language appears in a section regarding the elements of the ‘regulatory framework’ used to ‘achieve’ the object of the Act (GTA, s.4(aa)). As such, precaution in the GTA exists alongside other elements of the regulatory framework that relate to providing ‘an efficient and effective system for the application of gene technologies’ and ensuring the scheme’s operation ‘in conjunction with other Commonwealth [that is, Federal] and State regulatory schemes relevant to GMOs and GM products’ (GTA, s.4(a) & (b)). In guidelines issued by the Regulator, known as the Risk Analysis Framework (RAF), which explain how the Regulator carries out

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the process of risk assessment and risk management required by the GTA, the reference to precaution in section 4(aa) is interpreted as an indication that ‘the Regulator is required to take protective measures as a prudent and sound response in the face of a lack of full scientific certainty’ (OGTR, 2005, p. 9). However, the RAF goes on to say that this ‘pillar’ of the regulatory framework must be given equal weight to the others mentioned in section 4 and that ‘the Regulator is required to balance these in the implementation of the Act’ (OGTR, 2005, p. 8). The legal significance of precaution as one factor to be ‘balanced’ against others in implementing a regulatory framework is unclear (Gullett et al., 2001), particularly as no further mention of precaution is made in the remaining provisions of the Act. Moreover, there is no substantive context or normative reference point for the operation of precaution in the GTA. Proposals for the Act to incorporate concepts of ecologically sustainable development, which underlie other Australian environmental legislation and are accepted in Australian environmental policy to encompass precaution (see Stein, 2000), were not ultimately adopted (Senate Community Affairs Committee, 2000, p. 46). The fashion in which precaution is expressed in the GTA is thus equivocal – it is not a mandatory consideration in the decision-making process of risk assessment and risk management, but neither is it clearly a discretionary matter for the Regulator given its place as a ‘pillar’ of the Act’s regulatory framework. Nonetheless, the very presence of precautionary language, together with the fact that this language was inserted following a Senate Committee inquiry that considered the need for a ‘precautionary approach’ to GMO regulation, means that community expectations of ‘precautionary’ decision making under the Act remain prevalent. ‘Precaution and general safety’ concerns are raised in public comments on Risk Assessment and Risk Management Plans (RARMPs)6 and the precautionary principle has been a topic of discussion before the ‘community consultative’ committee established by the GTA.7 The need for ‘caution’,8 and the ways in which caution can be integrated into the framework for risk assessment and risk management, are also matters that were recently revised in the RAF (OGTR, 2005, pp. 15–16). The ongoing debate about the role of precaution under the GTA means that, whether binding or not as a formal legal matter, the Regulator will face pressure, from both within and without, to explain how ‘precautionary’ concerns over uncertainty are taken into account in decision making. While it is not clear from the form and manner in which precaution has been incorporated in the GTA whether it is to be interpreted as requiring a ‘comprehensive’ consideration of uncertainty or ‘broader’ conceptions of risk assessment as discussed above, it is argued that both community expectations of precautionary decision making and also efforts by the Regulator to improve the way in which risk assessment and


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risk management accommodate uncertainty are countered by current features of the legislative scheme. As discussed below, these provisions of the GTA, when applied by the Regulator in accordance with ‘the regulatory system’s focus upon the scientific evaluation of risks’ (OGTR, 2005, p. 13), tend to produce a narrower consideration of uncertainties arising in respect of GMO environmental releases than the ‘precautionary’ assessment advocated in this chapter would require. Public Input into Risk Assessment In line with the recognition that a critical feature of any contemporary risk regulatory scheme is that it ‘remains relevant to the science it oversees, the community it protects, and the industry it regulates’ (Senate Community Affairs Committee, 2000, p. 27), the risk assessment and risk management structure established by the GTA seeks to integrate input from a range of ‘stakeholders’. However, the Act’s commitment to a ‘scientific’ process of risk assessment (OGTR, 2005, pp. 10–11) means that, in the identification and evaluation of risks raised by a particular GMO release, the perspectives of scientists and regulatory experts play a more substantial role than those of the public. Under section 51 of the GTA, risk assessment is the first part of the process that must be undertaken by the Regulator in preparing a ‘risk assessment and risk management plan’ (RARMP) for a GMO licence application involving the intentional release of a GMO into the environment (for example, in a field trial or as part of commercialization of a GM crop). This assessment will be based on information deriving from technical material provided with the application, as well as other sources of scientific data, expert opinion and overseas GMO regulatory assessments available to the Regulator (OGTR, 2005, pp. 44–6). As part of the risk assessment process, it is mandatory for the Regulator to seek, and take into account, the advice of various regulatory bodies: State and Territory governments, Federal regulatory agencies with responsibilities extending to GM products, the Federal Environment Minister and any local council that the Regulator considers appropriate (GTA, ss.50(3) & 51(1)). Advice must also be sought and considered from an expert technical advisory committee, known as the Gene Technology Technical Advisory Committee (GTTAC), made up of specialists from various scientific and technical disciplines relevant to the assessment of GMO risks. By contrast, public participation in risk assessment for GMO licence applications is subject to a discretionary judgement by the Regulator. Public consultation on an application, prior to risk assessment, is required where ‘the Regulator is satisfied that at least one of the dealings proposed

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to be authorised by the licence may pose significant risks to the health and safety of people or to the environment’ (GTA, s.49(1)). The notion of a ‘significant risk’ is not defined in the GTA, although the legislation specifies a number of factors to which the Regulator must have regard in making this decision. These factors are listed as: ● ● ● ● ● ●

the properties of the conventional organism from which the GMO is derived; the effect of the genetic modification that has occurred on the properties of the organism; provisions for limiting the dissemination or spread of the GMO or its genetic material in the environment; the potential for spread or persistence of the GMO or its genetic material in the environment; the extent or scale of the proposed dealings; and any likely impacts of the proposed dealings on the health and safety of people (GTA, s.49(2)).

While this list of considerations is not exhaustive (in the sense that other factors can be added by way of regulations made by the Federal executive government) it currently references only technically-oriented, evidencebased matters relating to the potential risks posed by a GMO release and the management of those risks. Assessments of the ‘significance’ of risks or impacts on health or the environment generally take account of a much broader range of concerns that relate not only to the technical dimensions or measurable properties of effects, but also their social importance. Indeed, the Regulator’s discussion of ‘significance’ in the RAF (in the context of evaluations of the adverse consequences of a hazard undertaken as part of risk assessment) suggests that this inquiry extends to questions over the ‘severity’, ‘seriousness’ and ‘acceptability’ of effects, as well as their potential to be long-term, cumulative or irreversible (OGTR, 2005, p. 41). In the context of environmental impact assessment, the traditionally broad nature of assessments of the ‘significance’ of environmental impacts reflects the fact that they require a combination of scientific judgements about the extent of harm and community judgements about whether harm is to valued ecosystems or is more or less important when traded off against potential benefits (Thomas and Elliott, 2005). The notion of a ‘significant impact’ in environmental impact assessment legislation is thus usually interpreted to require an evaluation of both questions of ‘intensity’, which are susceptible to quantification (for example, the duration, frequency or extent of an effect), as well as ‘contextual’ factors, which are qualitative in nature.9 As the latter factors implicate more directly value judgements


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about the relative importance of different ecosystems and any effects upon them, determinations of ‘significance’ often elicit a range of views from different members of the community. Hence it is argued that such determinations in environmental impact assessment should ideally involve ‘a collective judgment of officers, elected persons, and the public’ (Gilpin, 1995, p. 7). This is facilitated by broad public consultation provisions and the ability of decision makers to balance environmental concerns with social and economic considerations in reaching a final determination. By contrast, the restricted range of criteria in the provision in the GTA requiring a decision on the potential ‘significance’ of health or environmental risks posed by a particular application limits the basis on which the Regulator can make this decision to essentially technical matters. The Regulator is thus unable to assess the ‘significance’ of risks posed by a particular licence application taking account of the full range of factors that will affect community, as well as scientific, judgements on this question. As a result, the information feeding into the risk assessment process for a GMO licence application will usually be limited to technical data, scientific opinion and the views of regulatory bodies. Without the benefit of a ‘broader’ perspective on the available information regarding risk and its potential limitations, the risk assessment that follows will be less wellequipped, it is argued, to undertake a ‘comprehensive’ evaluation of the issues of uncertainty that arise. To date, the Regulator has not found any licence application to be one that ‘may pose significant risks’ invoking a requirement under section 49 for public consultation on the application prior to preparation of a RARMP, despite the fact that some applications – such as those for commercial release of varieties of the food crop GM canola – have generated considerable public debate (Tranter, 2003).10 While this application of section 49 is consistent with the GTA’s premise that decisions on GMO releases should be focused on questions of health and environmental ‘risk’, rather than a balance of risk and other social and economic considerations, it highlights a more fundamental problem with the legislative scheme discussed further below. Namely that the Act favours a conception of the issues and uncertainties surrounding GMOs that accords with scientific views but tracks far less successfully the ways in which those issues are understood and debated by the general community. Regulator’s Narrow Risk Assessment Mandate While the scope for public consultation on an application prior to risk assessment is limited by the requirements of section 49 of the GTA, this is not the only point at which public consultation occurs in the overall

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decision-making process on a GMO licence application. Following the preparation of a RARMP for a particular GMO dealing, the Regulator must invite written submissions from the public on the plan (GTA, s.52(2)(c)) in addition to seeking the advice of the same regulatory bodies and GTTAC who were consulted initially on the application (GTA, s.52(3)). This information is then taken into account by the Regulator when deciding whether to issue a licence and in determining what (if any) specific licence conditions to impose. In making this decision, the Regulator is subject to a general duty not to issue a licence unless she is satisfied that any risks posed by the proposed dealings are able to be managed in such a way as to protect the health and safety of people and the environment (GTA, s.56(1)). Public submissions on the RARMP, in addition to the risk assessment and the risk management plan itself, are matters to which the Regulator must have regard in evaluating whether risks can be appropriately managed (GTA, s.56(2)). While the GTA thus gives public views a role in the licensing process, their practical impact is frequently limited by the narrow scope of the Regulator’s risk regulatory mandate under the Act. If concerns raised by the public do not match the restricted range of risks the Regulator is permitted to consider, they are noted in the relevant RARMP to fall outside the scope of the Act and are not taken into account by the Regulator in the licensing decision.11 Constraints on the risks the Regulator is able to consider in the process of risk assessment and risk management under the GTA flow from the legislative focus on ‘risks to the health and safety of people or risks to the environment’ evaluated on the basis of scientific data and expert opinion (GTA, s.51(1)(a); see also OGTR, 2005, p. 11). Although the matters to be considered by the Regulator in risk assessment extend to the long-term potential of the GMO to ‘be harmful to other organisms’ and ‘adversely affect any ecosystems’ (Gene Technology Regulations 2001, r.10) – matters that might encompass a broad evaluation of ‘harms’ and the different ways in which they are evaluated by different groups in society (Levidow and Carr, 1997) – several features of the GTA direct the Regulator towards a much more ‘scientific’ assessment of these factors. For example, the definition of ‘environment’ included in the Act (GTA, s.10) excludes any reference to social, economic or cultural aspects of the environment found in comparable definitions under other Federal environmental legislation. Together with the consensus that emerged in the preparatory process for the legislation that ‘marketing’ and ‘economic’ issues should not be encompassed by assessments under the scheme, the narrower definition of ‘environment’ in the GTA means that the socio-economic dimensions of environmental risks posed by GMOs, such as the potential for GM agriculture to impact on the viability of non-GM farming practices, are excluded from its ambit


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(OGTR, 2005, pp. 12–14). Also falling outside of the Regulator’s regulatory mandate are any risks that may arise at a later stage of the GMO’s commercial lifecycle, for example, when it is processed to become a food or, for herbicide tolerant GM plants, when they are used in conjunction with herbicides in broad-acre agriculture. Instead, these issues are treated by the scheme as the regulatory responsibility of other Federal agencies (OGTR, 2005, pp. 96–9). The effect of such divisions is to create categories of GMO issues, some of which fall within the Regulator’s risk assessment mandate under the GTA (for example, ‘health and environmental risks’) and others that fall outside it (the ‘social’ and ‘economic’ consequences of the commercial release of GMOs, ‘consumer concerns’ and potential changes in ‘weed management practices’). Of those matters that fall outside the scope of risk assessment, some can be taken up at a policy level by the Act’s advisory committees for ‘ethics’ and ‘community consultation’ (OGTR, 2005, p. 13). This manner of compartmentalizing concerns over GMOs maps very well to the ways of understanding GMO risks favoured by scientific experts and regulators (see Levidow et al., 1997), but far less successfully to those favoured by the broader public. As Wynne (2001, p. 447) argues, the ‘institutionalised divorce of risk concerns from ethical concerns’, which is characteristic of many GMO regulatory schemes, ‘fails to see that public meanings and responses do not even fit these categories, let alone agree or disagree with them’. Rather than adhering to what are in reality rather artificial boundaries between objective ‘risk’ and value-laden ‘ethical’ concerns (Levidow and Carr, 1997), public views about GMOs are far more likely to mix questions of science, judgements about uncertainty and issues of how particular ecosystems are valued. The Regulator’s narrow risk assessment mandate under the GTA has important consequences for the extent to which these views, expressed in public submissions on a RARMP, are taken into account in the decision-making process on a GMO licence application. A large portion of the public submissions received on a RARMP may be excluded from the scope of consideration by virtue of being categorized as relating to ‘consumer concerns’, ‘marketing’ issues or ‘ethical’ matters (Tranter, 2003). In so doing, the scope for ‘broader’ views to draw attention to issues of uncertainty that tend to be systematically underestimated by experts and regulators in risk assessment will be significantly diminished.

CONCLUSION: PRECAUTIONARY ONLY IN NAME? As it currently stands, the regulatory regime established by the GTA places significant limitations on the capacity of the Regulator, when assessing

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applications for the environmental release of GMOs, to undertake a ‘comprehensive’ evaluation of issues of scientific uncertainty of the kind that would be consistent with the ‘precautionary’ process advanced in this chapter. Since a number of the uncertainties of relevance to decision making about GMO releases are of a complex or intractable nature, a more ‘open’ risk assessment process is crucial to ensuring that such uncertainties are taken into account ‘adequately and meaningfully’ (Fisher, 2005, p. 19). Although the GTA was devised after extensive public consultation and makes provision for public involvement in a number of ways, I have argued that these mechanisms of public participation are not appropriately structured to facilitate a ‘precautionary’ consideration of the uncertainties at issue in GMO risk assessment. This produces disjuncture between the precautionary language in section 4 of the GTA, and the design of the remainder of the decision-making framework, which tends to bring about a narrower, ‘scientific’ evaluation of issues of uncertainty. One element of the present scheme that contributes to this disjuncture is the limited scope of operation of the discretionary public consultation provision under section 49. If this were the only limitation of the GTA in achieving a comprehensive consideration of uncertainty in decision making on GMO licence applications it might be easily remedied. Indeed, section 49(2)(g) allows the Federal executive government to add further considerations by way of regulations to the list of matters the Regulator must have regard to in determining whether a particular GMO licence application ‘may pose significant risks’ to the health and safety of people, or to the environment. A broader range of considerations, drawing on experience from the analogous area of environmental impact assessment, could give this provision a more expansive operation, allowing pubic consultation on applications at an earlier stage of the decision-making process (see also Levidow and Carr, 1997). If public views were taken into account prior to risk assessment for an application, at a time when the Regulator is identifying the hazards that arise and establishing the relevant ‘risk context’ (OGTR, 2005, pp. 29–35), they could play a constructive role in the consideration of uncertainty, for example, by facilitating debate over the strengths and weaknesses of available scientific evidence or by allowing a clearer delineation between issues of ‘fact’ and ‘value’. Nevertheless, enhanced public participation in earlier stages of the risk assessment process would not provide a complete solution to the criticisms of the scheme from the ‘precautionary’ perspective advocated in this chapter if restrictions on the Regulator’s risk assessment mandate under the GTA remained. Currently the Act’s exclusion of ‘socio-economic’ and ‘marketing’ concerns, ‘consumer’ issues and ‘ethical’ matters from the ambit of risk assessment is justified on the basis that this allows a ‘scientific


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evaluation’ of the health and environmental risks posed by GMOs free from the ‘compromising’ influence of economic considerations (OGTR, 2005, p. 13). However, a further consequence of defining the scope of permissible risk assessment in this way is that it tends to screen out a significant portion of public views, which do not conform as readily to categories of ‘risk’ and ‘other’ concerns as the opinions of scientists and regulatory experts. Even if public comments were received on an application at an earlier stage in the risk assessment process, they would still be in danger of being excluded from playing a role in risk evaluation because they often do not fit the expert categorization system used in describing what can (and cannot) be assessed and managed under the GTA. Thus, the majority of public comments would probably still be seen as ‘about’ social, ethical or consumer concerns, rather than as reflecting a different understanding of, or response to, issues of uncertainty from that presented by ‘experts’. Given the limitations of the current GTA scheme that have been identified in this chapter, I argue that implementing a ‘precautionary approach’ to GMO regulation, rather than merely a process that assesses risks and associated uncertainties in line with ‘expert’ views, will necessitate legislative change. While additions to the matters for consideration under section 49 might be made by way of regulations, removing constraints on the Regulator’s risk regulatory mandate could only be achieved by the passage of amendments to the GTA through the Federal Parliament. Such a recalibration of the regulatory regime is unlikely to be an easy task, possibly involving a negotiation and consultation process as extensive as the initial one undertaken in establishing the regulatory framework. It would also require attention to as yet under-explored questions regarding the best ways to take account of public comments in risk-related decision-making processes (Rowe and Frewer, 2000), including how to ensure that the comments that are received are reflective of community views as a whole, and how to integrate the insights they provide with more traditional scientific and regulatory inputs. Nevertheless, it is becoming clear that the challenges of ‘democratizing’ risk assessment processes in this way are not only critical to ensuring a ‘precautionary’ assessment of the intractable uncertainties surrounding some novel technologies, but also to instilling public confidence in the technology itself and its regulation (Levidow and Carr, 1997). Notably, it is the failures of the GTA scheme as a means for promoting public confidence in the application of gene technology that have drawn the most stringent criticism from commentators (Hain et al., 2002; Tranter, 2003). The Australian experience with the inclusion of precaution in a GMO risk regulatory framework may also offer broader lessons for schemes in other environmental fields or in other countries. As the operation of the

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Australian GTA scheme illustrates, implementing a ‘precautionary approach’ to GMO regulation requires attention to the design of the underlying risk assessment process in terms of the manner and extent to which it takes account of scientific uncertainty. Where the risk assessment process is likely to encounter questions of uncertainty that are intractable, precaution will rarely be able to be implemented adequately without consideration being given to the appropriateness of decision-making structures for integrating views beyond those of scientists and other ‘experts’. As regulatory systems around the world move increasingly into an era of precautionary implementation, these questions of how to give effect to precaution in substance and not just name will be ones that assume growing importance.

NOTES 1. 2.

3.

4.

5.

6. 7.

8.

9. 10.

Rio Declaration on Environment and Development, UN.Doc.A/CONF.151/26 (1992). In other Australian environmental legislation containing the precautionary principle, such as the Federal Environment Protection and Biodiversity Conservation Act 1999, the reference to the ‘cost-effectiveness’ of protective measures has been removed. However, this terminology has been retained in the GTA, s.4(aa). For a recent example of this approach see De Brett Investments Pty Ltd and Lamason v. Australian Fisheries Management Authority [2004] AATA 704 (Unreported, Administrative Appeals Tribunal, 30 June 2004). Other relevant Australian case law is discussed in Fisher and Harding (2001). Various terms are used in different regulatory systems to describe this phase of risk regulation, including ‘risk assessment’, ‘risk evaluation’ and ‘risk analysis’. The term ‘risk assessment’ is employed here as this is the term used in the legislation and by the Regulator to describe the initial process of health and environmental risk evaluation. The Senate Committee had in fact recommended inclusion of the slightly broader formulation of the precautionary principle found in other Federal environmental legislation such as the Environment Protection and Biodiversity Conservation Act 1999, which does not contain a reference to ‘cost-effective’ protective measures. For example, the summaries of public comments provided in RARMPs for controversial applications such as the commercial release of GM canola varieties reveal a large proportion of comments regarding ‘precaution and general safety’ concerns. In recent meetings, the Gene Technology Community Consultative Committee has heard presentations on the precautionary principle: see Quarterly Report of the Gene Technology Regulator for the period 1 July–30 September 2004, p. 22, available from http://www.ogtr.gov.au/pdf/public/sept2004qrpt.pdf (accessed 21 October 2005). In Australian case law, the precautionary principle is often interpreted as a requirement for ‘cautious’ decision making. As a consequence, it is common for decision makers and regulatory authorities to describe precaution in terms of a requirement for ‘caution’. See further Fisher and Harding (2001). See, for example, the case of Booth v. Bosworth (2001) 114 FCR 39, 65 discussing the meaning of ‘significant impact’ as used in the Federal Environment Protection and Biodiversity Conservation Act 1999. For example, the RARMP issued for Bayer’s InVigor® canola application resulted in 256 written submissions to the Regulator, together with 531 ‘campaign’ letters and emails, and five petitions representing 471 signatories.

Precautionary only in name? 11.

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For example, RARMPs for applications involving the commercial release of GM canola listed the following matters raised by public comments as ‘issues outside the scope of assessment’: ‘agricultural practices’, ‘economic/market issues’ and ‘other general issues’. Further, issues relating to ‘herbicide use and resistance management’ and ‘safety and labeling of GM foods’ were excluded as issues that are the responsibility of other Federal agencies.

REFERENCES Cameron, J. and J. Abouchar (1996), ‘The status of the precautionary principle in international law’, in David Freestone and Ellen Hey (eds), The Precautionary Principle and International Law: The Challenge of Implementation, The Hague: Kluwer Law International, pp. 29–52. De Sadeleer, N. (2002), Environmental Principles: From Political Slogans to Legal Rules, Oxford: Oxford University Press. Fisher, E. (1999), ‘The precautionary principle as a legal standard for public decision-making: the role of judicial and merits review in ensuring reasoned deliberation’, in Ronnie Harding and Elizabeth Fisher (eds), Perspectives on the Precautionary Principle, Leichhardt, Australia: Federation Press, pp. 83–98. Fisher, E. (2005), ‘Precaution, law and principles of good administration’, Water, Science and Technology, 52 (6), 19–24. Fisher, E. and R. Harding (2001), ‘The precautionary principle in Australia: from aspiration to practice?’, in Timothy O’Riordan, James Cameron and Andrew Jordan (eds), Reinterpreting the Precautionary Principle, London: Cameron May, pp. 215–33. Fisk, D. (1998), ‘Environmental science and environmental law’, Journal of Environmental Law, 10 (1), 3–8. Gilpin, A. (1995), Environmental Impact Assessment (EIA): Cutting Edge for the Twenty-First Century, Cambridge: Cambridge University Press. Gullett, W. (2000), ‘The precautionary principle in Australia: policy, law and potential precautionary EIAs’, Risk: Health, Safety and Environment, 11, 93–124. Gullett, W., C. Paterson and E. Fisher (2001), ‘Substantive precautionary decisionmaking: the Australian Fisheries Management Authority’s “lawful pursuit” of the precautionary principle’, The Australasian Journal of Natural Resources, 7 (2), 95–135. Hain, M., C. Cocklin and D. Gibbs (2002), ‘Regulating biosciences: the Gene Technology Act 2000’, Environmental and Planning Law Journal, 19, 163–79. Klinke, A. and O. Renn (2002), ‘A new approach to risk evaluation and management: risk-based, precaution-based, and discourse-based strategies’, Risk Analysis, 22 (6), 1071–94. Levidow, L. and S. Carr (1997), ‘How biotechnology regulation sets a risk/ethics boundary’, Agriculture and Human Values, 14, 29–43. Levidow, L., S. Carr, R. von Schomberg and D. Wield (1997), ‘European biotechnology regulation: framing the risk assessment of a herbicide-tolerant crop’, Science, Technology and Human Values, 22 (4), 472–505. National Research Council (NRC) (2002), Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation, Washington, DC: National Academies Press.

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Office of the Gene Technology Regulator (OGTR) (2005), Risk Analysis Framework, Canberra, Australia: Commonwealth Government. Rowe, G. and L. Frewer (2000), ‘Public participation methods: a framework for evaluation’, Science, Technology and Human Values, 25 (1), 3–29. Santillo, D., R.L. Stringer, P.A. Johnston and J. Tickner (1998), ‘The precautionary principle: protecting against failures of scientific method and risk assessment’, Marine Pollution Bulletin, 36 (12), 939–50. Senate Community Affairs Committee (2000), A Cautionary Tale: Fish Don’t Lay Tomatoes, Canberra: Commonwealth of Australia. Slovic, P. (2000), The Perception of Risk, London: Earthscan. Stein, P.L. (2000), ‘Are decision-makers too cautious with the precautionary principle?’, Environmental and Planning Law Journal, 17, 3–23. Stirling, A. and P. van Zwanenberg (2003), ‘A general model for the precautionary regulation of risk’, in O. Renn, M. Dreyer, A. Klinke, C. Losert, A. Stirling, P. van Zwanenberg, U. Muller-Herold, M. Morosini and E. Fisher (eds), The Application of the Precautionary Principle in the European Union, PrecauPri Project, Stuttgart: Centre for Technology Assessment, pp. 10–27. Sullivan, R. and A. Hunt (1999), ‘Risk assessment: The myth of scientific objectivity’, Environmental and Planning Law Journal, 16, 522–30. Thomas, I. and M. Elliott (2005), Environmental Impact Assessment in Australia: Theory and Practice, 4th edn. Sydney, Australia: Federation Press. Tranter, M. (2003), ‘A question of confidence: an appraisal of the operation of the Gene Technology Act 2000’, Environmental and Planning Law Journal, 20, 245–60. Wynne, B. (1992), ‘Uncertainty and environmental learning: reconceiving science and policy in the preventative paradigm’, Global Environmental Change, 2 (2), 111–27. Wynne, B. (2001), ‘Creating public alienation: expert cultures of risk and ethics on GMOs’, Science as Culture, 10 (4), 445–81.

PART III

Prospective Applications of the Precautionary Principle in Specific Fields

11. A long and winding road? Precaution from principle to practice in biodiversity conservation Rosie Cooney INTRODUCTION Biodiversity includes the diversity of genes, species and ecosystems on earth,1 but here for convenience I focus on species loss and ecosystem degradation. At least five times since life evolved on Earth, mass extinction events have taken place, involving the extinction of vast numbers of species (Futuyma, 1998). Perhaps over 95 per cent of all species that have lived on earth are now extinct (Rosenzweig, 1995), and a ‘background’ level of extinction is to be expected regardless of human activities (Macleod, 2002). Today, however, relevant indices point to our being on the cusp of the sixth great extinction event, this one distinguished by the fact that it is caused primarily by human activities (Leakey and Lewin, 1995). Around one in eight of the world’s bird species, a quarter of its mammals, and one in three amphibians are threatened with extinction (Baillie, Hilton-Taylor and Stuart, 2004). The extent and rapidity of anthropogenically-induced recent and threatened extinctions far outstrips the rate of evolution of new species and threatens fundamental ecosystem processes which maintain all life on earth. Many would view the extinction of other species as alarming per se. However, threats to biodiversity are also threats to humans: to the provision of materials and services for life, health, security and wellbeing. Biodiversity provides food, medicine, fuel and building materials. Biodiverse ecosystems help filter water, control flooding, regulate climate, decompose waste, generate soil and pollinate crops. They provide aesthetic, recreational and spiritual benefits, and are fundamental in soil formation and fertility, photosynthesis and nutrient cycling. Today around 60 per cent of the ecosystem services that support life on Earth are being degraded or used unsustainably (Millennium Ecosystem Assessment, 2005). While humans 223

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are buffered against environmental changes by culture and technology, they remain and will continue to remain fundamentally dependent on biodiverse, healthy ecosystems. Uncertainty surrounds virtually every aspect of this actual and threatened loss of biodiversity. We know that the major proximate causes of loss of biodiversity are loss and degradation of habitat (due to deforestation, conversion to agriculture, aquaculture, urbanization, and so forth); the impacts of invasive alien species; and over-exploitation (over-fishing, overhunting, over-harvest) (Baillie et al., 2004). However, attempts to conserve biodiversity and manage wild resources face uncertainty and ignorance about a wide range of parameters (Dovers and Handmer, 1995). We do not know (to the nearest ten million) how many species currently exist (May, 2000). There are major gaps in our knowledge of the status of threatened species: while the status of vertebrates is relatively well documented, we know little about non-terrestrial systems (freshwater and marine), or many species-rich habitats (such as tropical forest or the ocean depths), or species-rich groups such as invertebrates, plants and fungi (which together compose the overwhelming majority of species). Our understanding of the interactions between species in complex systems is in its infancy (Redford and Feinsinger, 2001), and we understand little about the long-term biodiversity impacts of interventions and innovations such as widespread tropical deforestation, dramatically increased trade and transport between regions, and commercialization of many wild resources. The precautionary principle is of immediate and widespread relevance in the biodiversity context: indeed, it has been argued that it applies to biodiversity more than to any other environmental problem, due to the dramatic and irreversible nature of current extinction patterns (Myers, 1993). It is all the more relevant because uncertainty has been, and still is, frequently used as a reason not to take action to conserve biodiversity. In this chapter I explore a number of challenges and problems for efforts to construct precautionary policy, regulatory and management frameworks which effectively (and equitably) address the threats to biodiversity. These challenges are discussed with reference to the levels of deliberation characterized by von Schomberg (this volume, chapter 2), and the terminology set out therein of invocation, implementation and application of the precautionary principle is adopted. In this chapter I follow the view of de Sadeleer (2003) that the distinction drawn between the terms ‘precautionary principle’ and ‘precautionary approach’ is largely a ‘semantic squabble’ with little practical significance. I therefore use these terms and the term ‘precaution’ interchangeably.

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PRECAUTION IN BIODIVERSITY-RELATED LAW AND POLICY First, however, I provide a brief survey of precaution in biodiversity law and policy. The immediate relevance of the precautionary principle to efforts to conserve and manage biodiversity has led to a widespread political recognition of the precautionary principle in this arena and its widespread invocation in law and policy instruments. This section provides a selective summary, drawing on a lengthier review in Cooney (2004), highlighting three policy areas in which precaution has been a focus of particular debate and attention. Multilateral Agreements The United Nations Conference on Environment and Development (UNCED, Rio de Janeiro, 1992) was a major catalyst for widespread invocation of precaution in relation to biodiversity and living natural resources. A general statement of the principle is expressed in the Rio Declaration (1992, Principle 15), and the Preamble of the Convention on Biological Diversity (CBD, 1992) invokes the principle in the following terms ‘Where there is a threat of significant reduction or loss of biological diversity, lack of full scientific certainty should not be used as a reason for postponing measures to avoid or minimize such a threat’. The precautionary principle has subsequently been extensively included in CBD decisions and related work on a wide range of issues, including biosafety, marine and coastal biodiversity, invasive alien species and sustainable use of wild living resources. The Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES, 1975) adopted in 1994 a version of the principle to guide decisions by Parties as to which species should be listed in the CITES Appendices and subject to international trade controls (see below). While other major global biodiversity agreements of broad scope such as the Ramsar Convention on Wetlands (1971) and the Convention on Migratory Species (1982) do not include the precautionary principle in Convention texts, it has been incorporated in various subsequent resolutions and subsidiary agreements.2 Many regional conservation instruments now invoke the precautionary principle. For instance, the newly amended (not yet in force) African Convention on the Conservation of Nature and Natural Resources (2004) contains a strong endorsement of the precautionary principle as part of its fundamental obligation. In the European Union, the 1992 EC Directive on the Conservation of Natural Habitats and of Wild Flora and Fauna (Directive 92/43, the Habitats Directive) does not explicitly incorporate the

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precautionary principle, but states that in the case of a project likely to have a significant effect on a protected site ‘competent national authorities shall agree to the plan or project only after having ascertained that it will not adversely affect the integrity of the site concerned . . .’. This reversal of the evidentiary presumption represents a form of application of the precautionary principle. A number of agreements related to specific taxa or species also invoke the precautionary principle, such as the Agreement on Conservation of Cetaceans of the Black Sea, Mediterranean Sea and Contiguous Atlantic Area (ACCOBAMS, 1996), the African-Eurasian Waterbird Agreement (1995), and the Agreement on the Conservation of Albatrosses and Petrels (2001). National Level The precautionary principle is increasingly widely explicitly incorporated in national law and policy related to biodiversity (for instance in Australia, Costa Rica, Argentina and Cameroon), frequently within legislation implementing the CBD. Of course, many countries not explicitly incorporating the precautionary principle into law or policy may nonetheless establish regulatory or management frameworks which embody strong precautionary elements. In many countries, including Australia and Costa Rica, the precautionary principle has been a key issue in legal disputes related to biodiversity. Key Policy Areas i. International wildlife trade CITES involves international trade controls on species listed in its Appendices. Species listed in Appendix I may not be commercially traded, and trade in species included in Appendix II is regulated by a permit system. CITES Resolution of the Conference 9.24 (Rev CoP13) requires that the Parties, when considering proposals to amend Appendix I or II ‘shall, by virtue of the precautionary approach and in case of uncertainty either as regards the status of a species or the impact of trade on the conservation of a species, act in the best interest of the conservation of the species concerned and adopt measures that are proportionate to the anticipated risks to the species’. Further specific ‘Precautionary measures’ restrict the circumstances under which species can be transferred from Appendix I to Appendix II. Overall, therefore, the specific operative effect of the precautionary principle under the terms of the relevant resolution is to weigh in favour of species protection when making listing decisions


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(subject to the requirement that such measures are proportionate), and in favour of maintaining Appendix I species in Appendix I. However, it has been pointed out that the precautionary principle is commonly used in advocacy and debate within CITES as an argument specifically in favour of increased trade regulation and of trade bans or restrictions (Dickson, 1996, 1999 and see Wold, 1985). CITES provides for Parties to adopt ‘stricter domestic measures’ with respect to trade in wild species (Article XIV(1)), such as additional limitations on the import of particular taxa. Typically such measures are motivated by precautionary considerations, as they respond to uncertainty surrounding management of harvest and trade, enforcement, and/or species status. Such stricter import restrictions are, for instance, relied on by the USA and the European Union. CITES provisions are implemented through measures taken at the national level, including the making of findings that trade will not be detrimental to the wild population (see Articles III and IV), the establishment of export quotas and a choice of harvest or management strategies. These decisions are frequently made in conditions of substantial uncertainty and the precautionary principle may be given operational effect by national management authorities. A range of further controls on wildlife access, use and trade are usually operative at the national level. ii. Fisheries Fisheries have major actual and potential impacts on biodiversity, deriving not just from impacts on target species, but via incidental capture (often of vulnerable species such as sea turtles, sharks and dolphins) and habitat destruction (such as by deep-sea trawling). Recognition and incorporation of uncertainty has been a major driver of the evolution of fisheries policy and regulatory approaches in recent years, and the precautionary approach to fisheries management has emerged strongly in international, regional and national fisheries law and policy. It is probably within the fisheries context that the concept of precautionary resource utilization and management has received the most detailed attention and fullest elaboration to date (for comprehensive analyses see Freestone, 1999; Juda, 2002). The UN Fish Stocks Agreement (FSA)3 was the first global fisheries agreement requiring a precautionary approach, which is to be applied to fisheries conservation, management and exploitation measures. The precautionary approach is increasingly adopted by many regional fisheries agreements, such as the North Atlantic Salmon Conservation Organisation (NASCO) and the International Commission for the Conservation of Tunas (ICCAT). The Food and Agriculture Organization of the United States (FAO) has led the development of a voluntary Code

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of Conduct for Responsible Fisheries which strongly endorses the precautionary approach, and has developed detailed technical guidance for implementation of the precautionary approach (FAO, 1995). This guidance represents one of the most detailed treatments of the operational meaning of precaution in a natural resource management or conservation arena. At national level, some States have incorporated the precautionary principle, or text analogous to it into fisheries legislation and policy, including Australia, South Africa and New Zealand. iii. Biosecurity The precautionary principle has become increasingly important in policy efforts to address the threats to biodiversity posed by invasive alien species and genetically modified organisms. The CBD’s Guiding Principles4 on invasive alien species, the status of which remains contested due to controversy over the precautionary approach, invokes the precautionary approach as the first Guiding Principle. It specifies that lack of scientific certainty about the environmental, social and economic risk posed by a potentially invasive alien species or by a potential pathway should not be used as a reason for not taking preventative action against the introduction of potentially invasive alien species, and that lack of certainty about the long-term implication of an invasion should not be used as a reason for postponing eradication, containment or control measures. The precautionary approach is also included in guidance on invasives developed under other agreements.5 From a biodiversity viewpoint, genetically modified organisms can be seen as a special case of a potentially invasive alien organism. The Cartagena Protocol on Biosafety (2000) to the CBD reaffirms the precautionary approach in relation to the trade of living genetically modified organisms (LMOs). Key requirements include an Advance Informed Agreement procedure for transboundary movements of LMOs, and risk assessments by importing States. It is reaffirmed in several places that lack of scientific certainty shall not prevent import States from taking action to avert potential risks.

KEY CHALLENGES AND QUESTIONS This section highlights and discusses a series of challenges and questions which face efforts to establish and elaborate precautionary policy and management frameworks for biodiversity conservation.


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The Extent and Nature of Uncertainty It is necessary to begin by examining the specificities of uncertainty and threat in the biodiversity context. In a number of important respects, this ‘green’ context diverges significantly from the ‘brown’ scenarios (dealing with industrial and urban issues such as pollution, toxic chemicals and food safety) upon which most discussion of the precautionary principle has focused. As stated above, conservation and management of biological resources must typically deal with uncertainty. At least two forms of uncertainty can be distinguished (this discussion follows Walker et al., 2003). Epistemic uncertainty derives from missing, inadequate or incomplete data, linked to lack of investigation, sampling error or measurement biases. In principle, this form of uncertainty can be ‘solved’ by more investigation or data. In most contexts in which the precautionary principle has been extensively discussed, this is the form of uncertainty countenanced. Application of the precautionary principle is therefore viewed as a provisional or temporary measure to be maintained until scientific investigation progresses adequately to describe more fully the risk. For instance, we may exercise precaution about a novel chemical until we better understand its toxicity to humans. While there is a high degree of this form of uncertainty when analysing threats to biodiversity, there is also a less tractable form. Ontological or variability uncertainty derives from the intrinsic nature of the system being studied, due to its complexity, scale, stochasticity, dynamics and so forth. These make understanding or prediction of outcomes inherently impossible or highly unreliable. Ecosystems, particularly the most biodiverse, are composed of myriad interacting species engaged in complex interactions with each other and with abiotic factors such as nutrients, temperature and hydrological regimes. They exhibit the dynamics of complex systems, characterized by chaotic dynamics, threshold effects, state changes and inherent stochasticity. Experimentation involving any but the simplest variables is not generally possible. This form of uncertainty is not temporary or provisional, but an inherent feature of threat scenarios to be addressed by regulation and management. Most formulations and discussions of the precautionary principle posit precaution as a response to ‘scientific’ uncertainty. However, the uncertainties which precaution must confront in the biodiversity realm typically go well beyond strictly defined ‘scientific’ uncertainty (see Dovers and Handmer, 1995). Biodiversity conservation scenarios involve a close and complex interaction between natural and human systems. A decision maker contemplating applying the precautionary principle in response to an uncertain threat of overexploitation of a timber species must consider not

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only uncertainties relating to biological factors (what are the trends in forest cover? what is the distribution and status of a particular tree species? is a particular forest bird in decline?); the consequences of these changes for biodiversity and associated ecological functions (is harvest level of a species threatening it with extinction? what is the impact of logging practices on forest fauna? will a particular intensity of logging impact on watershed functions or lead to soil erosion?); but also what factors drive the overexploitation (poverty? over-consumption? market failure? poor enforcement?); and what effective interventions are likely to look like (a logging moratorium? stricter penalties? changes to pricing? community forestry?) While the boundaries of ‘science’ are subject to dispute, relevant uncertainties clearly go well beyond the biological and ecological sciences and into the murky realms of the dynamics of human social, economic and political systems. The Nature of Threats The nature of the threats which precautionary regulation and management must tackle in the biodiversity context are also significantly different. The precautionary principle emerged to deal with – and its current evolution is largely shaped by addressing – new processes or products, usually the result of technological development, such as industrial chemicals, hormonetreated livestock or nanotechnology. The uncertainties faced are scientific uncertainties related to the causal nexus between a substance or process and damage to environmental or human health. In the context of biodiversity conservation, threats posed by qualitatively novel processes or technologies exist (for example, from GMOs or toxic chemicals), but are globally less important than threats posed by magnification and spread of familiar processes. Forests are cleared by chainsaw or hand, wetlands are drained and concreted, wildlife is trapped, shot and snared. There is no particular mystery, particularly concerning causal links, comparable to a new, poorly understood technology or chemical. The harm results not from major, poorly understood discrete activities but from the large and poorly understood incremental impact of myriad small and well-understood acts. Valuing Biodiversity and the Level of Protection The level of protection to be extended to biodiversity, and how threats to biodiversity are to be balanced against socio-economic costs, are important normative choices which are rarely well-defined in biodiversity-related law or policy. Stakeholders vary widely in how they value biodiversity and how they view trade-offs with other values, even within the constituency broadly


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in favour of environmental protection. Some focus on the welfare and rights of individual animals, and seek to avert suffering or death of individuals. Some seek to conserve biodiversity as a whole for its intrinsic and aesthetic value, and prevent any significant loss of biodiversity. Some seek to ensure the continued provision of utilities such as ecosystem services, like freshwater supply or microclimate regulation, rather than biodiversity per se. Some aim to sustain livelihoods, income or ways of life rather than species or ecosystems, and may tolerate major reductions in stocks or simplification of ecosystems to do so. In most decision-making contexts, interest groups with no stake in environmental protection will also be involved. Values are likely to vary from the local, to national, to global level, and may diverge between North and South. This provides fertile ground for conflict over the precautionary principle, and highlights the need for transparent and participatory decision-making processes when applying it. Tensions Between Sectors Threats to biodiversity are mediated not just through laws and policies aimed at biodiversity conservation or natural resource management (NRM), but through policies in a very wide range of other sectors. An international trade agreement to expand trade in soybeans may lead to loss of vast areas of tropical forest. Extending an agricultural subsidy regime encouraging intensive production may lead to dramatic loss of rural biodiversity. Trade, agriculture, transport, industry, tourism and forestry are only the most obvious policy areas with major potential impacts. While law and policy for biodiversity conservation frequently and now perhaps typically invoke the precautionary principle, and this is true also of some biodiversity-related ‘natural resource’ sectors such as fisheries, in these other sectors recognition of, and support for, the precautionary principle may be very much weaker. Lack of a shared awareness and acceptance of the precautionary principle across different sectors of law, policy and management presents major challenges for implementation, leading to policy incoherence, inconsistent approaches to threats, and poor implementation of the principle. International law and policy on forests is illustrative. A disproportionate amount of terrestrial biodiversity – the vast majority – occurs in tropical forests. However, forestry law and policy has traditionally focused primarily on exploitation and management of the timber resource, and incorporation of biodiversity conservation concerns is a relatively recent feature. Despite the prominence of the precautionary principle at UNCED in 1992, it was a highly controversial subject during negotiations for, and

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was not reflected in, the Statement on Forests6 adopted at that meeting (Humphreys, 1996). Likewise, the precautionary principle is not reflected in the International Tropical Timber Agreement (Yokohama, 1992), the CBD programme of work on forests (see Decisions IV/7, V/4, VI/9), the Global Strategy for Plant Conservation (Decision VI/9), or the deliberations of the United Nations Forum on Forests, the International Forum on Forests or the International Panel on Forests. Biosecurity provides another good example. The legal and political acceptability of import restrictions (to conserve biodiversity) based on the precautionary principle is a key locus of actual and potential conflict between the multilateral environmental and trade regimes. The instruments discussed above on biosafety and invasive alien species both strongly endorse application of the precautionary approach. However, the precautionary principle is highly controversial within the World Trade Organization, and in marked tension with the provisions of the WTO agreement of major relevance, the Sanitary and Phytosanitary Agreement (SPS). The SPS is designed to ensure that SPS measures are not disguised restrictions on international trade, and (as interpreted through dispute resolution) places substantive limitations on the scope for precautionary action in the face of scientific uncertainty.7 Translating the Principle into Practice Invocation of the precautionary principle in policy or law will have little substantive or consistent impact on practice if not accompanied by ‘materialization’ of the principle into more detailed regulatory or management frameworks and measures that address the threats. For instance, after a decade of precaution being incorporated as a broad obligation in Australian environmental law, it is not clear that it has had a consistent impact on practice (Fisher and Harding, 2001; Sant, in press). Many invocations of precaution in biodiversity-related law use non-mandatory language: the principle is stated to ‘inspire’ a policy instrument, decision makers ‘may have regard to’ the precautionary principle in making a decision, or the precautionary principle appears only in preambular texts. Such invocations will typically have less impact than those in which applying the precautionary approach is set out as an obligation in the operative text of an instrument, and linked to specified process or outcome standards developed on a sectoral or thematic basis, with respect to, for instance, specific species, industries, fisheries or protected areas. Furthermore, the precautionary principle relies for its effective application on a supportive legal, policy, institutional, administrative, procedural and technical framework. Where there are governance problems such as


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corruption, poor enforcement, low capacity, or lack of inter-institutional coordination, it will be difficult to apply the precautionary principle. As conservation priority areas typically lie in countries with the most serious governance problems (Smith et al., 2003) this represents a major challenge. Distributional Impacts and Equity Implementation and application of the precautionary principle in the biodiversity context can raise difficult questions of its relationship to development, poverty alleviation and equity. Debate and practical operation of the precautionary principle (and biodiversity conservation in general) must be viewed in the policy context of ‘sustainable development’ with its three pillars of environmental, social and economic sustainability (World Commission on Environment and Development, 1987), rather than in the context of pure ‘environmentalism’ (Dovers and Handmer, 1995; O’Riordan, 1999). Furthermore, the Millennium Development Goals adopted by the United Nations represent an unprecedented global consensus on the roadmap for human development, highlighting poverty eradication as Goal 1. As biodiversity is overwhelmingly located in the poorer, less developed regions of the world, the interrelationship between these imperatives is crucial. The links between biodiversity conservation and poverty are complex and context-specific, depending on scale, geography, social and political dynamics and context (Adams et al., 2004; Department for International Development, 2002; Roe et al., 2002; Kepe, Saruchera and Whande, 2004). However in many familiar biodiversity-related scenarios the costs of adopting a precautionary approach can fall on poorer and less powerful groups, and exacerbate existing distributional inequities (Dickson, 2003). ‘Protectionist’8 biodiversity strategies raise the most serious equity concerns (Mohammed-Katerere, 2001; although whether ‘precautionary’ should necessarily be equated with ‘protectionist’ is a controversial question discussed further below). This approach emphasizes strict protected areas and restrictions on use and trade of wildlife, and is usually characterized by ‘top-down’ regulation and enforcement, rather than by community-based approaches or incentive-based strategies. While all people rely on biological resources, less developed countries and poorer people tend to rely more heavily and directly on use and trade of their biological resources (Department for International Development, 2002; Koziell and Saunders, 2001). For instance, the number of poor people dependent on wild products for at least part of their income range from estimates of 200 million worldwide to 1 billion just in Asia and the Pacific (van Rijsoort, 2000), and up to an estimated 80 per cent of the world’s population depends on traditional

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healthcare from wild products (World Health Organization, IUCN and WWF, 1993). International trade controls on wild resources can undermine local livelihoods and incomes (Roe et al., 2002), as well as involving administrative costs and loss of revenue to government agencies which must implement them. Designation of strict protected areas can impose substantial costs on local people, including expulsion, lost access to resources and undermined livelihoods (Brockington, 2002; Ghimire and Pimbert, 1997; McShane, 2003). Uncertainty regarding the impacts on biodiversity may be explicitly used as a rationale for excluding people from traditional uses of wild fauna and flora (Risby, 2002). The allocation of the burden of proof in the biodiversity context has particularly important potential equity impacts. Application of the precautionary principle often reverses the burden of proof, so that proponents of potentially damaging activities are required to demonstrate that an activity is unlikely to cause harm (see Wingspread Statement, in Tickner, 2003). However, those responsible for resource management, or reliant on natural resource use in biodiverse tropical biomes often have little money and technological capacity compared to their counterparts in more developed countries. They will therefore seldom be able to satisfy the information and scientific requirements to the standards of the industrialized world, and a strict application of the precautionary principle will have inequitable impacts (Freese, 1996). Asking indigenous or local communities to demonstrate that their use of non-wood forest products, sea turtle eggs or pasture was not causing any harm would be tantamount to ending the livelihood activities of a substantial proportion of the world’s rural poor. Effective and equitable implementation of the precautionary principle would seem to demand an integrated policy and management framework that addresses environmental, social and economic dynamics. At the international level, the international sustainable development law principle of ‘common but differentiated responsibility’9 is relevant. However, the socioeconomic impacts of the principle are not necessarily well-integrated into application of the precautionary principle, although this varies widely across sectors and contexts. For instance, the CBD recognizes in its Preamble, along with the precautionary principle, that economic and social development and poverty eradication are the priorities of developing countries. FAO guidance on the precautionary approach in fisheries incorporates consideration of socio-economic elements in a number of ways (FAO, 1995). However, under CITES, it is clear from language on ‘the best interests of the species’ that conservation impacts are assigned priority in the application of the precautionary principle, and there is no obligation or process for considering livelihood or socio-economic impacts of


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conservation measures based on the precautionary principle (Roe et al., 2002; CITES; 2005). Implementing a stronger precautionary approach at all levels, while taking into account equity impacts, will arguably require a much greater North-to-South flow of investments into research and capacity building, and compensation for the impacts of conservation measures for local stakeholders who forego returns from use of biological resources in order to satisfy others’ desire for reduced risk (Freese, 1996). Questions of equity are closely linked to questions of participation in decision making. Particularly when politically or economically less powerful interests are affected, precautionary decision making will be more equitable, and often more effective, when affected stakeholders and interests are consulted and involved. As discussed above, different stakeholders have different perceptions of the values of natural resources. Different priorities may have equal validity, and effective management needs to reconcile these perceptions and priorities and build a level of consensus around sustainable management strategies. Local values of biodiversity in particular tend to be poorly documented (Vermeulen and Koziell, 2002), and conservation measures which are unresponsive to local priorities and perceptions of environmental threat may have poor conservation outcomes (Brockington and Schmidt-Soltau, 2002). At international level, precautionary trade controls to conserve biodiversity in other States (CITES ‘stricter domestic measures’ – see above) are often unilaterally imposed without consultation with the groups affected. However, these too may be more effective, as well as equitable, when accompanied by consultation with the stakeholders affected (Morgan, 2003). What is the Precautionary Strategy? Translating explicit invocations of precaution into operational measures in the biodiversity context will involve a wide, highly context-specific range of measures, tools and approaches. Given that uncertainty is a long-familiar feature of biodiversity and natural resource management, it is also the case that many decisions, policy measures or management regimes may be regarded as implicitly precautionary, despite lack of any explicit inclusion of or reference to the precautionary principle. These can be characterized as involving risk-averse measures which cannot be unambiguously justified by available scientific or other information, and will be equally varied. Explicitly or implicitly precautionary measures might involve, inter alia, moratoria on hunting, fishing, or logging; leaving a ‘margin of error’ on quotas for extraction or harvesting of a resource; banning potentially harmful activities such as introduction of alien species; establishing monitoring programmes to provide early warning of threats of biological

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degradation or species decline; establishing bans or controls on trade of wild resources; and so forth. However, biodiversity conservation and NRM often involve ‘multiple risks’: it may not be straightforward to judge which of two competing strategies should be considered precautionary (Freese, 1996). This provides another contrast to most contexts of use of the precautionary principle. In the case of regulation of carcinogens or hazardous waste, for instance, there will typically be a clear precautionary or low-risk option: that which limits production, exposure or release. Decisions are between ‘risk’ and ‘caution’. However in NRM and conservation, decision makers are often confronted with a choice of strategies which each carry attendant environmental risks – the choice is between risk and risk. If people are prevented from harvesting coral reef fish for trade, they may dynamite the reef for cement. If harvest of medicinal plants and wild foods from a forest is prohibited, people may resent such restrictions and actively oppose further conservation efforts. Management of an ecosystem for the benefit of commercially valuable species may yield economic benefits that ensure that the habitat is not converted to agriculture, but may lead to alterations detrimental to other species. What does applying the precautionary principle mean in these situations? There is a tendency in some conservation sectors to view the more protectionist strategy – that which involves the strongest prohibitions or restrictions on use and trade of wildlife – as necessarily the most risk-averse and precautionary. This will often be justifiable: where open-access resources such as high-seas fisheries are concerned, for instance, there will rarely be conservation benefits associated with utilization. However, the equation is often made with little detailed examination of context and potential consequences. Prohibitive precautionary measures may themselves carry negative conservation consequences. Potential negative consequences of trade prohibitions include creating a black market, which means illegal, unregulated and unmonitored trade; boosting demand for rare and illegal species (in some specialist sectors) (TRAFFIC, undated); and undermining local livelihoods and thereby local support for conservation (Lombard and du Plessis, 2003). For instance, the Tanimbar corella Cacatua goffini was listed in Appendix I of CITES, banning commercial trade, in response to concern about biological impacts of international trade. Listing was based on the precautionary principle, as biological information on species status was inadequate. While trade decreased, Jepson, Brickle and Chayadin (2001) argue that the prohibition has had longer term negative impacts, causing resentment among local people (who perceived the bird as abundant and an agricultural pest) and local hostility toward conservation NGOs, and leading to the consequent abandonment of plans for a protected area in the region. Likewise, it


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has been pointed out that creation of strict protected areas that cause harm to local groups will be threatened by non-cooperation or outright resistance (Brockington and Schmidt-Soltau, 2004). The conservation benefits of strict protectionist strategies often rely on effective State enforcement and management, often unfeasible in developing countries and problematic in the most developed. It has been pointed out that State control and management of protected areas may be highly ineffective where there are neither resources nor political will for effective management, and exclusion of local people may remove the group with the strongest incentive for good management (Molnar, Scherr and Khare, 2004). Without strict and comprehensive enforcement, prohibitions may often not solve the conservation problem, but simply drive it underground and/or make it impossible to monitor or manage. For instance, Kenya has a long-standing ban on the consumption and trade of wild meat, a precautionary response to concerns about overexploitation. It has been argued that the combination of lack of adequate resources to police such a ban, with a lack of incentives for wildlife management, plus the need of rural people for meat, has led to widespread poaching and rapidly declining wildlife populations (Barnett, 2005). On the other side of the equation, it is also clear that utilization and trade of wild resources can provide conservation benefits (Hutton and LeaderWilliams, 2003). These include economic incentives for communities, private interests or States to conserve and manage wild lands, countering the pressures for conversion or uncontrolled grazing or harvesting (Child, 1995; Hutton and Webb, 2003; Oldfield et al., 2003; Johnson, 1997). Revenue from wildlife utilization and trade, including from direct sales of specimens or of permits and licences, is sometimes responsible for a substantial proportion of the budgets of wildlife departments. Consumptive use, such as trophy hunting, will sometimes be simpler to implement than alternative conservation strategies, and avoid other environmental risks associated with them. Ecotourism, for instance, frequently viewed as a more precautionary conservation strategy than sustainable use, requires substantial institutional capacity and infrastructure development, is vulnerable to a fickle tourist market, and carries attendant environmental risks such as habitat degradation and pollution (see for example, Roe, LeaderWilliams and Clayton, 1997). The threats that face biodiversity require careful assessment of different options, threats and opportunities. This complex set of costs and benefits – in different currencies, over different timescales, to different groups, and all uncertain – illustrates the challenges faced. It is important to note that it may be uncertainties deriving from lack of information or understanding of social/economic factors which affect the conservation impact of

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decisions. Adequate assessment will require examination of information drawn from well beyond the ‘natural sciences’, biology or ecology, and will need to assess information relating to a wide range of social, economic and institutional factors. Furthermore, indigenous and local people will often be primarily responsible for managing resources and wildlife, and may have a better understanding of the dynamics of threat and risk than formal scientific or other institutions. This knowledge and understanding needs to be incorporated into decision making. Paralysis by Precaution, or Adaptive Management? Particularly when considering actions which may impact on endangered species, a strong or ‘absolutist’ version of the principle is often used, which requires ‘proof’ that an activity will not harm biodiversity (Dickson, 1996). This may be highly appropriate, for instance where particularly vulnerable species or ecosystems are involved. However a highly prohibitive version risks ‘paralysis by precaution’: endless delay of management action in the face of endless uncertainty. ‘Doing nothing’ is often not an effective option in the conservation context, and a failure to take management action can itself have attendant conservation risks. For instance, the US Endangered Species Act embodies a strong ‘no harm’ understanding of the precautionary principle (Bodansky, 1994). Mealey et al. (2005) argue that in the management of some forests in the USA, a precautionary imperative to avoid short-term risks to endangered species has led to potentially jeopardizing their long-term survival. They argue that avoidance of management actions which would impact the forest in the short term but decrease the risk of catastrophic fire in the long term, have not been taken, thereby jeopardizing the long-term survival of the Northern spotted owl Strix occidentalis caurina. However, countering this potential for uncertain threats to paralyse management, conservation and natural resource management has in recent years strongly emphasized the concept and practice of adaptive management. This is a management approach that expressly tackles the uncertainty and dynamism of complex systems (Holling and Sanderson, 1996; Oglethorpe, 2002; Salafsky et al., 2001; Walters, 1986). While the term is used in various and not always well-defined ways, its hallmark is an emphasis on ‘learning by doing’. Adaptive management involves management actions that are designed as experiments to produce information about the resource being managed. It emphasizes making modest, reversible management interventions, careful monitoring of impacts and continual assessment and refinement of management practice as information increases. Management approaches to biodiversity conservation and NRM increasingly stress adaptive management. They are emphasized in, for instance, fisheries


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management approaches and advocacy, in the CBD Guidelines on Sustainable Use (Decision VII/12), and in environmental certification standards such as those of the Forest Stewardship Council (see FSC Principle 7.1, 7.2) and the Marine Aquarium Council (see MAC, 2001). In adaptive management mistakes are to be expected and to be learned from, but it is also precautionary in that irreversible mistakes are to be avoided (Freese, 1998). Adaptive management contrasts with absolutist versions of the precautionary principle, particularly those which reverse the burden of proof or require clear evidence of the safety of a practice in advance. It does not require extensive research in advance of management action (with associated delay and costs). However, in many contexts of conservation and NRM it represents a pragmatic and effective approach to implementing precaution and managing dynamic, ever-changing, and highly uncertain human/natural systems of resource use.

CONCLUSIONS Biodiversity conservation is an urgent and compelling current global imperative, and the precautionary principle should be seen as a fundamental policy principle underpinning this effort. However, equitable and effective implementation faces major challenges. Of all these perhaps the most profound is the balancing of different interests involved in precautionary decision making. This dilemma is common to all contexts where precaution is applied or debated, but unlike many ‘brown’ scenarios, in the biodiversity context those who may bear the immediate costs of precautionary decision making may be groups which are already vulnerable, disenfranchised and poor. In particular, conservation approaches based on restricting access to and use of biological resources can impose major livelihood costs, and reversing the burden of proof can involve the imposition of unfeasible technical burdens on poor communities or poor countries. Tensions around the precautionary principle in this context echo broader debates about how biodiversity conservation should be pursued in a world grappling with poverty, and how to achieve the elusive ‘win-win’ solutions which would make uncomfortable trade-offs between these values irrelevant.

NOTES 1. The Convention on Biological Diversity, Article 2 states that ‘ “Biological diversity” means the variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems’.

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2. These include, for example, the Ramsar Guidelines on Management Planning for Wetlands (Resolution VIII.14 Chapter VI) and the resolution on Allocation and Management of Water (Resolution VIII.1 Article 10.1), and the CMS resolution on Wind Turbines and Migratory Species (Resolution 7.5). 3. Agreement for the Implementation of Provisions of the United Nations Convention on the Law of the Sea of 10 December 1982 Relating to the Conservation and Management of Straddling Fish Stocks and Highly Migratory Fish Stocks (1995). 4. Guiding Principles for the Prevention, Introduction and Mitigation of Impacts of Alien Species that Threaten Ecosystems, Habitats or Species are included in Annex of Decision VI/23. See also Decision V/8. 5. Both the Convention on the Conservation of European Wildlife and Natural Habitats (Bern Convention, 1982) and the African-Eurasian Waterbird Agreement (AEWA), developed under the Convention on Migratory Species (CMS; 1979), have developed guidelines on introductions of alien species that incorporate the precautionary approach (see Bern Convention: Standing Committee No 57 (1997) and No 77 (1999); CMS: MOP Resolution 2.3). 6. Non-Legally Binding Authoritative Statement of Forest Principles for a Global Consensus in the Management, Conservation and Sustainable Development of All Types of Forests (1992). 7. The WTO-compatibility of trade-restrictive measures taken in the face of uncertainty with respect to threats posed by alien species was a key issue in the Australia-salmon (Australia – Measures Affecting Importation of Salmon Adopted 6 November 1998, WT/DS18/AB/R) and Japan-varietals (Adopted 22 February 1999, WT/DS76/AB/R) cases. Likewise, major differences over the precautionary principle between the EU and the US have emerged in a running dispute over trade in GMOs, echoing previous stances vis a vis precautions taken in the Beef hormones dispute (EC Measures Concerning Meat and Meat Products (Hormones) Adopted 13 February 1998, WT/DS26/AB/R, WT/DS48/ AB/R). 8. Note that the term ‘protectionist’ in this context should not be equated with the use of the term in the trade context. 9. The Rio Declaration states ‘In view of the different contributions to global environmental degradation, States have common but differentiated responsibilities. The developed countries acknowledge the responsibility that they bear in the international pursuit of sustainable development in view of the pressures their societies place on the global environment and of the technologies and financial resources they command’ (Principle 7).

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Walker, W.E., P. Harremoës, J. Rotmans, J.P. van der Sluijs, M.B.A. van Asselt, P. Janssen and M.P. Krayer von Krauss (2003), ‘Defining uncertainty: a conceptual basis for uncertainty management in model-based decision support’, Integrated Assessment, 4, 5–17. Walters, C. (1986), Adaptive Management of Renewable Resources, London: Macmillan. Wold, C. (1985), CITES and the Precautionary Principle: The Burden to Show that a Use is Sustainable, Washington, DC: Humane Society of the United States. World Commission on Environment and Development (1987), Our Common Future, Oxford: Oxford University Press. World Health Organization, IUCN and WWF (1993), Guidelines on the Conservation of Medicinal Plants, Gland, Switzerland: IUCN.

12. Climate change and the precautionary principle Jeroen van der Sluijs and Wim Turkenburg INTRODUCTION Scientific assessment of the risks of anthropogenic climate change has shown that there is a reasonable concern for the possibility of irreversible large-scale adverse effects in the long term. Examples of such effects are a severe reduction or shutdown of the Gulf Stream and the North Atlantic current, accelerated species extinction and extreme sea level rise. But deep scientific uncertainty on causality, timing, probability and magnitude of such adverse effects persists. This meets all the criteria of the definition of the Precautionary Principle (PP) proposed by von Schomberg (see chapter 2, Box 2.1, in this volume): Where, following an assessment of available scientific information, there are reasonable grounds for concern for the possibility of adverse effects but scientific uncertainty persists, provisional risk management measures based on a broad cost-benefit analysis whereby priority will be given to human health and the environment, necessary to ensure the chosen high level of protection in the Community and proportionate to this level of protection, may be adopted, pending further scientific information for a more comprehensive risk assessment, without having to wait until the reality and seriousness of those adverse effects become fully apparent.

In theory, the international community has acknowledged that the PP needs to be invoked here. In Article 3.3 of the United Nations Framework Convention on Climate Change (United Nations FCCC, 1992) it is stated that: The Parties should take precautionary measures to anticipate, prevent or minimize the causes of climate change and mitigate its adverse effects. Where there are threats of serious or irreversible damage, lack of full scientific certainty should not be used as a reason for postponing such measures, taking into account that policies and measures to deal with climate change should be costeffective so as to ensure global benefits at the lowest possible cost. 245

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In practice however, actions have been delayed and postponed. The Kyoto protocol has been watered down in the successive negotiations on the details of its mechanisms. Also, the level of protection for the climate chosen by, for instance, the EU is increasingly challenged. In this chapter we will review the management of climate risks from the viewpoint of the PP. Following this definition of the PP, we first explore the grounds for concern with a focus on potential irreversible large-scale adverse effects and associated uncertainties. Next we explore the issue of the chosen level of protection for climate change. Finally we discuss the implications of the PP for climate risk management and the science-policy interface.

THE RISKS OF ANTHROPOGENIC CLIMATE CHANGE In the geological past, major global climate changes have occurred. These changes had natural causes, such as variation in the distance between the sun and the Earth, changes in solar luminosity, meteor impact, volcanic activity and continental drift. Over the past 8000 years, climate on Earth has been relatively stable, which has been a key factor in the development of humanity. This development, however, brought far-reaching changes in land use and vegetation patterns (disappearance of old growth forests, emergence of agriculture and cattle breeding and so on) along with exponential growth in the use of commodities to fulfil the energy and material demand of the fast growing world population. As a consequence, the emission of greenhouse gases (such as CO2, CH4, N2O, SF6, CFCs and HFCs) has increased to a point where it has changed the composition of the atmosphere significantly. Analysis of the composition of air bubbles trapped in ice in the Vostoc ice core suggests that in the past 420 000 years the CO2 concentration has varied between 180 ppmv (parts per million by volume) during ice ages and 280 ppmv in the interglacial periods (Petit et al., 1999). Since the first industrial revolution, the atmospheric CO2 concentration has increased from the equilibrium concentration of 280 ppmv in 1750 to nearly 380 ppmv in 2005. For all greenhouse gases together, the CO2-equivalent concentration is now more than 450 ppmv. Present-day atmospheric greenhouse gas concentrations thus exceed the natural variability of the past half million years. After 10 years of Earth system research, the International Geosphere Biosphere Programme concluded that the human enterprise drives multiple, interacting effects that cascade through the Earth system in complex ways. The Earth’s dynamics are characterized by critical thresholds and

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abrupt changes. Human activities could inadvertently trigger changes with catastrophic consequences for the Earth system, which has moved well outside the range of natural variability exhibited over the last half million years at least. The nature of changes now occurring simultaneously in the global environment, their magnitudes and rates, are evaluated as unprecedented in human history. According to Steffen and Tyson (2001), the Earth is now operating in a no-analogue state. Assessment of the risks of climate change is based on a number of insights: understanding of the physical laws that govern the climate, historic trends, scenario analysis and model calculations. The increase in atmospheric greenhouse gas concentrations adds to the well-known natural greenhouse effect of the atmosphere by absorbing and re-emitting infrared radiation emitted by the Earth’s surface, thereby increasing the net downward flux of infrared radiation emitted by the atmosphere. The extra downward flux of infrared radiation to the Earth surface through this mechanism compared to the pre-industrial equilibrium energy balance of the earth is called the ‘radiative forcing’ of the climate. The extent to which this radiative forcing leads to changes in climate (temperature, evaporation and precipitation, circulation patterns and so on) depends on the complex interactions of a large number of poorly understood feedback loops in the Earth system. State of the art climate research as reviewed by the Intergovernmental Panel on Climate Change (IPCC (2001); Houghton et al., 2001) shows that globally, the average Earth surface temperature has increased by 0.7 ± 0.2°C since the late 19th century. The largest increase has occurred over the past 20 to 30 years. At the North Pole the observed temperature change is twice as big. In Europe, the observed warming is 0.95°C (European Environment Agency, 2004). Temperatures in winter have increased more than in summer. The observed rate of global warming is now 0.17 ± 0.05°C per decade. The seawater temperature has also increased. Differences in temperature increase between sea and land lead to changes in circulation patterns. Increased evaporation of water has led to a 2 per cent increase of precipitation over land. More important than the average rainfall is that at many places on Earth big changes in precipitation patterns have been observed, both positive and negative. The IPCC concluded in its second (Houghton et al., 1996) and third (Houghton et al., 2001) scientific assessment report that the observed climate change is for a substantial part attributable to human activities. Scenario studies by the IPCC (Nakicenovic and Swart, 2000; Houghton et al., 2001) have shown that human activity is likely to lead to further climate change with possibly severe impacts. It should be noted that even if

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atmospheric composition were fixed today, temperature would continue to rise because thermal inertia of the oceans causes the realized warming to lag several decades behind changes in radiative forcing. Moreover, temporary aerosol cooling masks part of the greenhouse warming. A recent study by Wigley (2005) showed that committed warming for present day atmospheric greenhouse gas concentrations could exceed an additional 1°C on top of the 0.7°C that has already been realized. However, without additional policies, greenhouse gas concentrations are projected to rise to 650–1215 ppmv, which could lead to a global mean temperature increase in 2100 of 1.5 to 6°C compared to 1990. These projections have been made using seven different climate models assuming a climate sensitivity – the equilibrium change in global mean temperature resulting from a doubling of atmospheric carbon dioxide concentrations – in the range 1.7 to 4.2°C. Recent uncertainty analysis of the sensitivity of the climate to changes in greenhouse forcing suggest that it covers a wider range. Using the technique of ensemble modelling to explore the propagation of model parameter uncertainty in the Hadley Centre Global Climate Model, Murphy et al. (2004) found a 5–95 per cent probability range for climate sensitivity of 2.4–5.4°C. Stainforth et al. (2005) found climate sensitivities on the high end of the range up to 11.5°C. Based on probability density functions representing uncertainty in climate sensitivity taken from eight different studies, Dessai and Hulme (2004) show that, while there appears to be confidence in the lower bound of climate sensitivity, the central value (50th percentile of the distribution) ranges from 2 to 6ºC. The range for the upper bound (for instance the 95th percentile) is even wider: it ranges roughly from 5 to 9°C across the eight attempts to quantify the uncertainty. Projected ranges published by IPCC in 1996 and 2001 do not reflect these uncertainties. However, IPCC projects and reports the transient temperature change for the year 2100, whereas committed climate change in that year is higher. Finally, one has to bear in mind that regional climate change can be significantly smaller (for example, near the equator) or larger (especially near the poles). The impacts of projected climate change are expected to be manifold. Because of limited understanding of a large number of feedback loops in the complex Earth system and inherent limitations to the predictability of climate on the local and regional spatial scales, uncertainty in climate projections are huge and partly irreducible. Effects can become manifest gradually and linearly, but can also be non-linear as a singular event. Gradual changes include the increase of temperature, sea level rise, melting of glaciers, increase in length of the growing season, increase in precipitation and increase of extreme weather events such as heat waves and super storms. Examples of non-linear effects are the possible strong reduction or even


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shutdown of the so-called thermohaline circulation in the oceans (which could lead to a cooling of North and North-West Europe), disintegration of gas hydrates in melting permafrost and in the oceans (which leads to massive emissions of the greenhouse gas methane), disintegration of the West Antarctic Ice Sheet or strongly increased melting of the Greenland Ice Sheet (which may lead to several metres of sea level rise in the long term).

POORLY-KNOWN PROBABILITY, HIGH-IMPACT EVENTS A number of possible irreversible large-scale non-linear impacts of climate change has been identified, ranging from a regime shift in the thermohaline ocean circulation and sea level rise of several metres to extinction of species and loss of unique ecosystems, migration of human populations (environmental refugees), changes in frequency and intensity of extreme weather events, reduction of food security and changes in the geographical distribution of diseases. Although our state of knowledge suggests that in the long term such impacts are plausible, it is not possible to quantify the magnitude and probability of each of these potential effects, especially at regional and local level. At the same time, the observed climate change in the past decades has led to several unanticipated impacts. An example of such a surprise is a recent collapse of a dyke in the Netherlands (August, 2003) in a period of extreme drought, leading to the flooding of a village. The dyke was made of local soil and it turned out that peat in the dyke had dried out, and as a result it had lost so much weight that the dyke could no longer withstand the pressure of the water. It was then realized that the Netherlands has thousands of kilometres of dyke made of local soil that contains peat. A large-scale monitoring system has now been set up to assure early detection of peat drying in dykes. Never in history had this type of dyke been exposed to such extreme drought and nobody had thought of this scenario. Because models anticipate climate change well beyond the natural variability of the climate in the past millennia, the climate may move outside of the part of the so-called ‘parameter hyperspace’ on which our knowledge of the dynamics of the present climate system is based. This implies that more unanticipated impacts and surprises are likely to occur. In the following we review in more detail grounds for concern of three poorly-known probability, high-impact events that may occur in a warming world: a shutdown of the thermohaline circulation in the oceans, extreme sea level rise through disintegration of ice masses and accelerated (massive) species extinction.

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Thermohaline Circulation The Gulf Stream and the North Atlantic current are part of a larger ocean circulation system known as the thermohaline circulation (THC). The THC is driven by gradients in temperature and salinity and it transports large amounts of heat to the North Atlantic regions. It strongly determines present day climates in Western and Northern Europe. The main ‘pump’ that drives the THC is the North Atlantic deep water formation: the combined effects of evaporation during the northward transport and cooling in the North Atlantic increase the salinity and density of the water to a point where it sinks. Theoretical and paleoclimatic evidence point to the possibility of rapid changes in the THC. Global warming is likely to lead to an extra influx of fresh water in the North Atlantic through increased rainfall and increased amounts of melting water, while with higher temperatures less sea ice is formed and thus less fresh water is extracted from the sea water. This could decrease the salinity and density of the surface sea water to a threshold point where it stops sinking, which would imply a shutdown of the THC. Model studies show that such a shutdown, once it occurs, is quasi-permanent due to a so called ‘hysteresis’ in the system’s response to changes in fresh water input: the fresh water input has to go back to a point far below the shutdown threshold point before the THC is switched on again, which may take several centuries. Paleologic evidence shows that such regime shifts in the THC have occurred several times in the geological past. This evidence also indicates potentially large regional climate impacts (Alley, 2003). Model studies suggest that a shutdown of the THC could lead to a local cooling of several degrees in the North Atlantic region within a few decades (Rahmstorf, 1995; Stocker et al., 2001). A study with the UK Hadley Centre climate model showed that in the first decade after the extreme case of a total shutdown of the THC, the annual mean cooling in the UK might be 3–5°C, and 2–3°C in the third decade. To put these numbers in context: typical decadal mean cooling during the Little Ice Age period was for the UK in the order of magnitude of 0.5°C and the coldest individual year in the UK during the Little Ice Age was 1740 with an anomaly in annual mean temperature of 2.5°C (Wood et al., 2003). Such a cooling of the Nothern hemisphere would reduce local evaporation, precipitation and wind regimes and global circulation patterns, which in combination with the regional cooling may lead to a wide range of severe impacts on ecosystems, agriculture, economies and so on. It is unknown what the threshold point is to trigger a shutdown of the THC and where the present THC is on the hysteresis curve that describes


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North Atlantic deep water formation as a function of fresh water input. Hence it is also not yet possible to assess whether this threshold point can be reached for any of the projected climate change scenarios presently considered. Some experts believe that there is a 50 per cent chance that a shutdown occurs for a global warming of 4–5°C. The present day global climate models fed with IPCC’s emission scenarios show a gradual weakening, but not a shutdown of the THC. Simplified Earth system models however, have shown the possibility of a shutdown under plausible greenhouse gas forcings (Wood et al., 2003). Deutch et al. (2002) argue that the present ocean observation system is so incomplete and infrequent that it would detect a change in THC intensity only after the point at which climate policy would be able to respond with effective mitigation. Extreme Sea Level Rise In the assessments of the risk of sea level rise through anthropogenic climate change, four factors play a role: thermal expansion of sea water, ice sheet dynamics, natural trends and other man-made causes of sea level rise (mainly ground water extraction). The ice sheet dynamics constitutes the most problematic factor in the assessments of future sea level as it harbours the largest uncertainties and can be non-linear. In Table 12.1 the present ice volumes and sea level equivalents of the Earth are given. If all ice on Earth were to melt, the worldwide average sea level would rise about 80 metres. The mass balance of ice sheets is quite complicated. Increase of temperature at the poles leads to increased evaporation of seawater and increased snowfall, positively contributing to the mass balance. At the same time the melting rate increases, which is a negative contribution. Morphological aspects (profiles of the bottom, shape and thickness of the ice shelves and so on) are a third factor, as they influence calving and streaming of the ice. Table 12.1

Ice components of land ice and their sea level rise equivalents Ice volume (106 km3)

East Antarctica West Antarctica Greenland Small ice caps and mountain glaciers Permafrost Source: Titus (1986).

25.92 3.40 3.0 0.12 0.03–0.7

Sea level rise equivalent (m) 64.8 8.5 7.6 0.3 0.08–0.17

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The research into the behaviour of ice sheets was originally part of a scientific discussion on the causes of sea level changes in the recent geological past. The debate on the stability of the West Antarctic Ice Sheet (WAIS) was initiated by John H. Mercer, a glaciologist. He was interested in the dramatic sea level changes during the last glaciation. He developed a hypothesis that sought to explain interglacial high sea levels by the deglaciation of West Antarctica. This hypothesis pointed out that fringing ice shelves, which are essential for the continued existence of an ice sheet grounded far below sea level, must consist of ‘cold’ ice below the pressure melting point, and will rapidly disintegrate by calving, if the average temperature of the warmest month rises above freezing point at sea level (Mercer, 1970). This theory opposed the accepted theory of Emiliani, which suggested that the high interglacial sea levels were the result of significant melting of the Greenland Ice Sheet. In 1978, Mercer linked up for the first time the stability of the WAIS with anthropogenic climate change. He suggested in an article in Nature that: If the global consumption of fossil fuels continues to grow at its present rate, atmospheric CO2 content will double in about 50 years. Climate models suggest that the resultant greenhouse warming effect will be greatly magnified in high latitudes. The computed temperature rise at latitude 80 degrees South could start rapid deglaciation of West Antarctica, leading to a 5 meter rise in sea level.

and: . . . deglaciation of West Antarctica would probably be the first disastrous result of continued fossil fuel consumption. . . . If so, major dislocations in coastal cities, and submergence of low lying areas such as much of Florida and the Netherlands, lies ahead.

Mercer’s theory gave rise to public concern and to a scientific debate on the stability of the WAIS. Further research in the 1980s pointed in the direction that the WAIS might be more stable than hitherto assumed and anticipated that warming in the coming century would not be large enough to initiate the complete melting of the West Antarctic ice shelves (van der Veen and Oerlemans, 1987). It should be noted that this assessment was biased by the time horizon chosen of one century, which is short in comparison to the typical time scales of ice sheet dynamics and does not account for committed warming. Later assessments exhibit the same bias. The first IPCC report concluded in 1990: ‘Within the next century, it is not likely that there will be a major outflow of ice from West Antarctica due directly to global warming’ (Houghton et al., 1990). In the third assessment report (Houghton et al., 2001) IPCC concluded that ice-dynamic instability of the


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WAIS and accelerated sea level rise are very unlikely during the 21st century for the range of projected warming. However, for warming of more than 10°C, simple runoff models predict that a zone of net mass loss would develop on the ice sheet surface. Irreversible disintegration of the WAIS would result because it cannot retreat to higher ground once its margins are subjected to surface melting and begin to recede. According to IPCC, once started, such disintegration would take at least a few millennia. The threshold for total disintegration of the East Antarctic Ice Sheet by surface melting is estimated to be about 20°C warming (Houghton et al., 2001). The Greenland ice sheet is the most vulnerable to climate warming but is not as potentially unstable as the WAIS, meaning that the melting would be a more gradual process. Models project that a local annual average warming of more than 3°C sustained for millennia would lead to virtually a complete melting of the Greenland ice sheet. For a local warming over Greenland of 5.5°C the Greenland ice sheet would contribute about 3 metres in 1000 years. For a warming of 8°C, the contribution is about 6 metres, the ice sheet being largely eliminated (Houghton et al., 2001). Species Extinction Shifting climate zones may lead to habitat loss and thereby to species extinction. Using projections of species’ distributions for future climate scenarios, Thomas et al. (2004) assessed extinction risks for sample regions that cover some 20 per cent of the Earth’s terrestrial surface. On the basis of mid-range climate warming scenarios for 2050, they found that 18–35 per cent of species would be ‘committed to extinction’. Note that the number committed to future extinction as a consequence of climate change over the next 50 years is not the same as the number of species that will become extinct during this period. Information is not currently available on time lags between climate change and species-level extinctions, but decades might elapse between area reduction (from habitat loss) and extinction. Land use should also be incorporated into analyses: extinction risks might be higher than projected by Thomas et al. if future locations of suitable climate do not coincide with other essential resources (such as soil type or food resources). According to the UN Millennium Ecosystem Assessment (2005) observed changes in climate, especially warmer regional temperatures, have already had significant impacts on biodiversity and ecosystems in many parts of the world. There have been changes in species distributions, population sizes and the timing of reproduction or migration events, as well as an increase in the frequency of pest and disease outbreaks, especially in forested systems.

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Although it is not possible to determine whether the extreme temperatures were a result of human-induced climate change, many coral reefs have undergone major, although often partially reversible, bleaching episodes when sea surface temperatures have increased during one month by 0.5–1°C above the average of the hottest months. Extensive coral mortality has occurred with observed local increases in temperature of 3°C. The Millennium Ecosystem Assessment further concludes that by the end of the century, climate change and its impacts may be the dominant direct driver of biodiversity loss and changes in ecosystem services globally. It will increase the risk of extinction for many species, especially those already at risk due to factors such as low population numbers, restricted or patchy habitats and limited climatic ranges.

THE CHOSEN LEVEL OF PROTECTION In risk management a widely used approach is agreeing on a normative choice for an acceptable risk level for the risky activity and putting enough measures in place to keep the risk below that level. This is problematic for three reasons. First, the degree to which people consider a risk acceptable or not depends not only on the magnitude of the damage and the probability that damage will occur, but on other risk dimensions as well. A given risk tends to be seen as less acceptable if the (perceived) controllability of consequences is lower; if the nature of the consequences is unfamiliar and dreadful; if one is exposed to the risk involuntarily; if the benefits of the activity are less clear and smaller; if the effects are more acute and closer in space and time; if risk and benefits are unfairly distributed; and if the likely harm is intentional (Vlek, 2004). Second, attitudes towards risks vary from person to person and across cultures. Some people have a risk-seeking attitude whereas others have a risk-averse attitude. Environmental risk attitudes tend to correlate with the way that people view nature. Those that see nature as robust tend to be risk-seeking, those that see nature as fragile tend to be risk-averse. In between are those that have a risk-regulating attitude, corresponding to a view of nature as ‘robust within limits’, and those that are indifferent to risk, corresponding to a view of nature as capricious or risk as fate (Douglas and Wildavski, 1982). One should further be aware that being risk-averse to ecological risks is not the same as being risk-averse to economic risks. This cultural plurality in risk attitudes implies that the question of how society ought to deal with risks can only be answered in public debate – a debate in which people will necessarily discuss their perception of risks and risk management from


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different points of view and different conceptual and ethical frameworks (Davidson, 2002). Third, in the case of the PP the acceptable risk approach is problematic because the uncertain nature of the risks makes it very difficult to set a safe level. Some argue that the PP reframes this choice into the question of how much harm can be avoided. Tickner (1999) for instance, illustrates that estimating a safe level of temperature increase is difficult and controversial. Reframing the question would change the focus from assessing a safe level to reducing greenhouse gas emissions as much as possible. Anyway, the international community has taken the more traditional risk approach by seeking to agree on a level of protection. This is laid down in Article 2 of the United Nations FCCC (1992): The ultimate objective of this Convention . . . is to achieve . . . stabilization of greenhouse gas concentrations in the atmosphere at a level that would prevent dangerous anthropogenic interference with the climate system. Such a level should be achieved within a time frame sufficient to allow ecosystems to adapt naturally to climate change, to ensure that food production is not threatened and to enable economic development to proceed in a sustainable manner.

The parties have not yet agreed on a quantified stabilization level for atmospheric greenhouse gas concentrations that is considered to meet this vaguely described level of protection. Because ecosystems have a maximum speed in keeping up with shifting climate zones, it is widely held that the rate of global warming has to be limited. Also, a maximum allowable global temperature increase has to be set. Further, in order to protect coastal ecosystems and coral reefs, limits have to be set on total sea level rise and rate of sea level rise. Finally, it is often argued that the third criterion mentioned in Article 2, to enable economic development to proceed in a sustainable manner, can be made operational by setting a limit to the maximum rate of emission reduction per year, so protecting economies from disruption by unrealistically strict policies. During their 1987 Villach-Bellagio workshops, the Advisory Group on Greenhouse Gasses (AGGG, the precursor of the IPCC) for the first time proposed long-term climate targets for temperature change and sea level rise to protect ecosystems (Jäger, 1990). They proposed for sea level rise: a maximum rate of increase of between 2 and 5 cm per decade and a maximum rise of between 0.2 and 0.5 m above the 1990 mean global sea level. For temperature, a maximum rate of increase of temperature of 0.1°C per decade was proposed, along with a maximum temperature increase of 1.0°C or 2.0°C above pre-industrial global mean temperature. These ‘Villach-Bellagio targets’ have played an important role in the climate policy debates since. They have inspired for instance the EU in its

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Sixth Environment Action Programme (European Commission, 2001), to set a long-term climate target of a maximum global temperature increase of 2°C over pre-industrial levels (which means 1.3°C above current global mean temperature) and a CO2 concentration below 550 ppmv. In December 2004 the EU revised its interpretation, stating that the 550 ppmv target is for the CO2-equivalent concentration (all greenhouse gases together rather than CO2 only). For CO2 this implies a stabilization level of 450 ppmv. This is likely to require a global reduction in emissions of greenhouse gases by at least 70 per cent as compared to 1990. In the discourses about the quantification of such levels of protection, key arguments have been parallels with past climates and paleological insights regarding how ecosystems have responded to major natural climate changes in the past. In the following we will review the underpinnings of such quantified levels of protection for climate change. Maximum Rate of Warming Much research has been done on the climate tolerance of ecosystems and species. The speed by which ecosystems can keep up with shifting climate zones depends on many factors. A major limiting factor is the seed cycle of trees. Analysis of pollen in sediment since the previous ice age shows that the maximum migration speed of trees varies between 4 and 200 km per century, depending on the species (Davis, 1989; Hinckley, 1997; Watson et al., 1997). For boreal forests, the speed by which climate zones shift towards the poles is critical. For Alpine ecosystems it is the speed by which climate zones shift upward. For coastal ecosystems the rate of sea level rise is critical. Roughly, a warming rate of 1°C per century produces a rate of sea level rise of 20 cm/century, a poleward shift of climate zones by 100 km per century and an upward shift of Alpine climate zones of 150 m. The most vulnerable ecosystems are the Alpine ecosystems. Many Alpine species are already committed to extinction for the current warming rate. Oak forests are also quite sensitive; the maximum rate of global warming with which they can keep up is estimated to be 0.12°C per century. Maximum Allowable Warming The aforementioned Villach Bellagio target specified two levels for maximum temperature increase, respectively 1.0°C and 2.0°C above preindustrial global mean temperature. The lower temperature target was set on the basis of their understanding of the vulnerability of ecosystems to historical temperature changes. Temperature increases beyond 1°C could


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trigger rapid, unpredictable and non-linear responses that could lead to extensive ecosystem damage. The absolute temperature limit of 2°C was judged to be as the limit beyond which the risks of grave damage to ecosystems and of non-linear responses are expected to increase rapidly. Krause et al. (1989) have sketched a context to grasp what different levels of global warming imply, by comparing them to the climate history of the Earth: ●

●

●

●

An increase of 1–1.5°C in global average surface temperature would imply a climate warmer than it ever was since 6000 years ago in the Holocene period, which was roughly the beginning of agricultural societies. A 2–2.5°C warming would imply a climate not experienced since the so-called Eem-Sangamon interglacial period some 125 000 years ago. At that time, human society consisted of hunter-gatherer societies and the West Antarctic Ice Sheet had partially disintegrated, raising sea levels by up to 5–7 metres. A 3–4°C warming would represent a climate not experienced since humans appeared on Earth (about 2 million years ago). The last time the Earth was this warm was in the Pliocene period (5 to 3 million years ago). A global average warming of 5°C and above corresponds to a climate not experienced for tens of millions of years. In that period there were no glaciers in the Antarctic and Greenland.

Risks for different levels of warming have been visualized qualitatively by IPCC on the basis of five risk indicators (Figure 12.1). The indicators used in this risk evaluation diagram are (IPCC, 2001): I

Unique and threatened systems: Some changes in species and systems have already been associated with observed changes in climate, and some highly vulnerable species and systems may be at risk for very small changes in climate. Greater warming would intensify the risks to these species and systems, and place additional ones at risk. II Extreme climate events: Increased frequencies and intensities of some extreme events have already been observed and are likely to increase with further warming, as would the risks to human life, property, crops, livestock and ecosystems. These risks increase where development is occurring in inherently dynamic and unstable zones (for example, river floodplains and low-lying coastal regions). III Uneven distribution of impacts: In general, developing countries are at greater risk of adverse impacts from climate change than are developed

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C 6 5

Risks to many

Large increase

4

Negative for most regions

3 2 1 0 1

Risks to some

Increase

Negative for some regions

I

II

III

I II III IV V

C 6

Net negative in all metrics Positive or negative market impacts; majority of people adversely affected

Very low

IV

V

Higher

5 4 3 2 1 0 1

Risks to unique and threatened systems Risk from extreme climate events Distribution of impacts Aggregate impacts Risks from future large-scale discontinuities

Source: IPCC (2001); reprinted with kind permission of the IPCC.

Figure 12.1 Risk evaluation diagram for different levels of global temperature change countries; some of the latter may experience market sector benefits for warming less than a few °C. For greater warming, most regions are at risk of predominantly negative effects from climate change. But developing countries generally would continue to be more severely impacted than developed countries. Within countries, vulnerability varies and the poorest populations often have higher exposure to impacts that threaten their lives and livelihoods. IV Global aggregate impacts: Globally aggregated market sector impacts may be positive or negative up to a few °C, though the majority of people may be negatively affected. With greater warming, the risk of negative global market sector impacts increases, and impacts would be predominantly negative for most people. V Large-scale, high-impact events: The probability of large-scale, highimpact events within a 100-year time horizon such as shutdown of the THC or collapse of the West Antarctic Ice Sheet is very low for


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warming of less than a few °C. For greater warming, and over a time horizon longer than 100 years, the probabilities and the risks increase, but by an amount that cannot now be estimated. Many ecosystems are sensitive to temperature. For instance, coral reefs around the Equator are sensitive to seawater temperature. When even during a short period the local seawater temperature exceeds 32–34°C, coral bleaching occurs. In a recent study, Leemans and van Vliet (2005) found that over the last decade, many more ecological responses to climate change have been observed than expected from the average 0.7°C warming trend alone. Current impact assessments of climate change are therefore likely to underestimate ecological impacts and vulnerability. Ecosystems respond faster to changes in extreme weather than to ‘normal’ climate characteristics. Based on these new insights into the vulnerability of species and ecosystems, Leemans and van Vliet suggest that the EU target is not strict enough and claim that ecosystem protection, in particular protection of coral reefs, makes it necessary to limit the increase in global mean surface temperature to 1.5°C above pre-industrial levels and to limit the rate of change to less than 0.05°C per decade. Based on the paleoclimate evidence, James Hansen, director of the NASA Goddard Space Center recently suggested that the highest prudent level of additional global warming (above the increase of 0.7°C already) is not more than about 1°C if we want to avoid the risks of large-scale ice sheet break up and associated extreme sea level rise. To achieve that, the atmospheric CO2 concentration should remain below 450 ppmv (Hansen, 2004). Maximum Sea Level Rise The Villach-Bellagio workshops (Jäger, 1990) proposed a maximum rate of sea level rise of between 2 and 5 cm per decade and a maximum rise of between 0.2 and 0.5 m above the 1990 mean global sea level. Since then, these targets have been criticized because they do not protect species and ecosystems that are highly sensitive to sea level rise such as coral reefs, mangrove ecosystems and coastal wetlands. Mangrove ecosystems protect 25 per cent of the tropical coastline. It is estimated that protection of mangrove ecosystems requires that the rate of sea level rise stays below 10 cm/century (Hinckley, 1997). Maximum Rate of Emission Reduction The rate by which greenhouse gas emissions can be reduced without disrupting the economy is limited. This is because the existing energy

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infrastructure can (without capital destruction) only be changed in a time frame of several decades. Krause et al. (1989) suggest a maximum rate of emission reduction of 2–3 per cent per year. Other studies that focus on energy efficiency improvement, renewables, technology development and structural changes of economies are more optimistic and suggest percentages up to 4 per cent per year (see for an overview, van der Sluijs and Turkenburg, 1998). Overall, the original Villach-Bellagio targets that were the basis for the EU target of 2°C over pre-industrial levels, which translates into 550 ppmv CO2 equivalents, is increasingly challenged as being insufficient to protect ecosystems and prevent non-linear climate change. As we saw, Leemans and van Vliet (2005) make a case for a limit of 1.5°C to protect ecosystems, whereas Hansen (2004) argues that a 1.7°C limit is required to avoid the risk of large-scale ice sheet breakdown. In any case, even for the presently agreed levels of protection, prevention of dangerous anthropogenic interference with the climate will require drastic greenhouse gas emission reductions, particularly of CO2. Options with major potentials to achieve this are energy efficiency improvement, renewable energy sources, CO2 capture and storage and nuclear energy. The latter two options can also involve major uncertain risks that may require a precautionary approach as well. It is however beyond the scope of this chapter to discuss these issues in detail.

IMPLICATIONS OF THE PRECAUTIONARY PRINCIPLE FOR RISK MANAGEMENT In risk management based on the prevention principle, risks can be managed by agreeing on an acceptable risk level for the activity and putting enough measures in place to keep the risk below that level. This approach is workable if the risks are well known and quantifiable in a credible way. The PP however deals with risks with poorly-known outcomes and poorlyknown probability, making this traditional approach problematic. The PP asks for a number of changes in scientific culture and in the way in which risk assessment and risk management are performed (Harremöes et al., 2001; Grandjean et al., 2003; UNESCO COMEST, 2005). In the following we will discuss these with a focus on the climate change case. Coping with Uncertainty The PP requires a science that better reflects uncertainty and complexity in the assessment of risks. Both qualitative and quantitative dimensions of


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uncertainty need explicit treatment. Uncertainties, along with the key assumptions on which knowledge claims on risks are conditioned, need to be made explicit and communicated clearly to the various actors involved in the discourse on these risks. This requires the further development and dissemination of multidisciplinary and multidimensional uncertainty analysis, which enables the delivery of policy-relevant quantitative information on risks together with the essential warnings about its uncertainties, limitations and pitfalls (van der Sluijs et al., 2005). The PP imposes a clear need to improve communication and requires reflection on various levels and types of uncertainty in scientific assessment. There is a pitfall to presenting high impact events of which the knowledge is so uncertain that there is no ground to estimate the probability, as ‘low-probability high-impact events’. We argue that it is better in such cases to talk about ‘poorly-known probability, high-impact events’. Patt (1999) has shown that the consensus building process in climate risk assessment tends to lead to strategic treatment of poorly-known probability, highimpact events: those issues on which no consensus can be achieved are under-addressed or ignored (for example, by categorizing them as ‘low probability’) whereas such issues may well be policy-relevant. As a consequence, in the development of many climate policy plans, non-linearity and surprise have been under-addressed and worst-case scenarios have not been included. Possible impacts in the case of warming of more than 4oC, or impacts in the case where (regionally) climate would cool rather than warm, have not been considered. Assessments have hardly looked beyond the year 2100. The focus has been on the state of the climate, while the trajectory of accelerated climate change and the committed climate change might be more important. All these omissions make society less prepared for possible surprises and potential disasters (van der Sluijs et al., 2002). At present, poorly-known probability, high-impact events are getting little attention in climate risk management, when objectively speaking, they may present a similar level of risk as say, high-probability low-impact events. In a precautionary approach, extreme events, surprises and worstcase scenarios should get a more prominent role in risk assessment and in the development of mitigation, adaptation and back stop options such as CO2 capture and storage capacity. Decision making under uncertainty further requires flexibility which can be related to timing of investments in, for example, energy infrastructure, timing with regard to tree cycles in forestry and so on. It also requires reversibility of policies and adequate monitoring of compliance to and effectiveness of policies. Finally, more focus will need to be put on the consequences of a possible failure of the international community to stabilize atmospheric greenhouse gas concentrations at a safe level in a timely manner.

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Enhance the Role of Vulnerability Science: Systematic Search for Surprises and Ways to Constrain Them To reiterate, models anticipate climate change well beyond the natural variability of the climate in the past millennia. The past is thus no longer a reliable key to the future and we can expect to meet surprises in our collective journey into Terra Incognita. Given the absence of adequate methodology to assess surprise, a systematic search for examples of surprises and nonlinear system behaviour from the past might be the prelude to a search for possible surprises in the future (Brooks, 1986). Other strategies that can help us to anticipate surprise include focusing on the underlying principles of surprise, which is what happens in surprise theory (Holling, 1986) and systematic ‘thinking the unthinkable’ by imagining unlikely (undesirable) future events or future states of the environment, followed by the construction of plausible scenarios by which they might be realized. From such an analysis we then hope to be able to identify precautionary intervention strategies that constrain the possibilities for the current system to develop towards such undesired states (Kates and Clark, 1996). A growing body of evidence as produced by paleoscientific studies reveals that major dynamic patterns, teleconnections and feedback loops in the total Earth system can be flipped to different modes of operation by internal and external perturbations, of which the thermohaline circulation regime is only one example. Revealing the mechanisms that bring about such ‘extreme events’ in the coupled nature-society system is a major scientific challenge. Novel approaches are needed that take full advantage of state of the art non-linear dynamics and complexity theory (for example, Bunde et al., 2002; Petschel-Held et al., 1999). A key challenge here is the advancement of vulnerability science, which is able to look at the responses of systems to multiple perturbations and stresses in models, and identify those directions that represent a catastrophic risk to the system under consideration (Schellnhuber, 2004). Enhance the Role of Monitoring and Empirical Research One of the difficulties in understanding complex environmental systems is that short-term observations (even of decades or a century) may be too short to reveal the full range of possible behaviours of the system. Scientists cannot use observations to demonstrate the existence of an alternative state that has not, for instance, appeared in the observational record. Therefore, the PP requires further development of models of integrated socialecological systems that exhibit complex behaviours on a variety of spatial and temporal scales. These models, which may reveal the existence of


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undesirable states and give some indication of the warning signals of change from one state to another, must be accompanied by a more intensive effort in monitoring. By placing a greater emphasis on direct measures to monitor observable effects systematically, a precautionary approach offers a way to be more responsive to harm when the first signals of it manifest themselves in the real world, however ambiguous these first signals may be. By an active search for early warnings, one can hope to reduce significantly society’s exposure to uncertainty and ignorance. For the case of the thermohaline circulation, Deutsch et al. (2002) have shown that a monitoring system to detect changes in THC in time to be useful for climate policy is possible by more and more frequent observations. They argue that the benefits of such an improved ocean observation system would considerably exceed the costs. Search for Robust Solutions that Increase Resilience Climate policy planning studies often take an average scenario for climate change as a starting point for the risk management strategy. By doing so, the strategy would not be adequate in the case where a THC shutdown were to cause a regional cooling in Western Europe. In searching for adaptation options one should strive for measures that are robust against such uncertainties. Such measures reduce the damage from both possible outcomes – warming and cooling. A key concept here is resilience. Resilience is the capacity of a system to tolerate disturbance without collapsing into a qualitatively different – usually undesired – state. For instance, a resilient ecosystem can withstand shocks and rebuild itself when necessary. Resilience in social systems includes the capacity of humans to anticipate and plan for the future, and to adapt to inevitable unanticipated conditions. Humans depend on ecological systems for survival and their actions are continuously impacting on ecosystems from the local to the global scale. Resilience is a property of these linked social-ecological systems. It has three characteristics: (1) the amount of change the system can undergo and still retain the same controls on function and structure, (2) the degree to which the system is capable of self-organization and (3) the ability to build and increase the capacity for learning and adaptation. The first two are also the focus of vulnerability science, and fostering the third should be a central element of any precautionary governance. In the case of forest management, robust measures include increasing the biodiversity and improving the water balance of the forest. In the case of food production, robust adaptation measures can be increasing the diversity of crops, developing crops with a broad climate and water tolerance, improving the management system for the water balance (irrigation and

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drainage), implementing food storage and distribution programmes to cope with crop failures, increasing trade in food products and providing insurance to enable farmers to cope with crop failures. For extreme weather events (storms, floods, droughts and so on), robust adaptation options could include the development of early warning systems, land use controls in vulnerable areas, developing insurance and compensation arrangements, modifying building codes and setting up international cost sharing mechanisms. Be More Realistic About the Role and Potential of Science in Assessment of Complex Risks Precaution entails a greater degree of humility or realism over the role and potential of science in the assessment of risks. Scientific and technical evidence and analysis remain essential. However – under a precautionary approach – scientific analysis is seen as a necessary, rather than a sufficient, basis for effective policy choices. More realism is also needed in the level of precision and confidence with which findings of risk assessment are expressed. The present focus on the quest for hard evidence rather than on the relative likelihood and plausibility of risks needs revision. Scientists are not bound to remove uncertainty – at least this may not be their primary task – but they can inform society about possible risks, or the background of what may be relevant for their audiences. Instead of a one-sided focus on ‘hard evidence’, plausibility requires scientific reasoning in order to explain certain observations or hypotheses so that they make sense to both expert and non-expert audiences and appeal to their understanding of the problem. Increase Societies’ Capacity to Act Upon Uncertain Early Warnings As a reviewer of this chapter pointed out, one could argue that scientists have been providing us with early warnings of climate change for at least two decades now. Although scientists could do so in a better and more sophisticated way, there is also an urgent need for a greater societal risk management process to cope with and act upon such uncertain warnings. The Late lessons from early warnings report (Harremoës et al., 2001) provides a number of recommendations in this regard, such as maintaining regulatory independence, identification and reduction of institutional obstacles to learning and action and avoidance of paralysis by analysis.


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Knowledge Partnerships for Precaution and Sustainable Development The PP implies a need for transdisciplinary approaches to science and policy. Science for policy in the face of uncertainty requires new transdisciplinary contacts and integration (internal extension of the peer community) on the one hand, and new contacts with policy makers, non-governmental organizations (NGOs), industry, media and the public (external extension of the peer community) on the other hand to meet the challenges of quality control in the assessment of complex risks. Because of the many uncertainties, traditional science is not able to provide sufficient support for the drastic steps that may sometimes be needed to deal with complex risks. The traditional dominance of ‘hard facts’ over ‘soft values’ has been inverted: hard value commitments may have to be made – even in the course of research design – based on soft facts. The assessment of risks and the setting of policy should therefore encompass public agreement and participation (Funtowicz and Ravetz, 1993). The knowledge and perspectives of stakeholders can bring in valuable new views and relevant information on that problem. Stakeholders can contribute to knowledge on local conditions which may help determine which data are strong and relevant or which response options are feasible. They may provide personal observations on the risk and its effects, which may lead both to new foci for empirical research, addressing dimensions of the problem which were previously overlooked, and to creative thinking about mechanisms and scenarios through which different sectors of society may be affected. Making full use of this reservoir of extra knowledge requires the establishment of an extended peer community not only in the phase where response options are debated, but also in the problem-framing and risk assessment processes that precede it. Further materialization of the PP requires not only a change towards a deliberative societal process of climate risk management but also a change in climate risk assessment towards fully-fledged management of uncertainty, inclusion of minority views and extended peer review of underlying assumptions. New platforms need to be established that bring together stakeholders, scientists working on evaluating risks and scientists working on options for risk reduction and more sustainable energy technologies and systems.

CONCLUSION Managing the risks of anthropogenic climate change poses a major challenge to society. A number of possible irreversible large-scale non-linear

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impacts of climate change has been identified, including a regime shift in the large-scale ocean circulation, extreme sea level rise if ice sheets disintegrate, and extinction of large numbers of species. Although our state of knowledge suggests that in the long term such impacts are plausible, it is not yet possible to quantify the magnitude and probability of each of these potential effects. To protect human societies and ecosystems from these risks, climate change should be kept within limits. A widely agreed limit for maximum acceptable warming is at present 2°C. Current projections of climate change for the coming century exceed this limit, showing the necessity of drastic emission reductions. Present day atmospheric greenhouse gas concentrations are outside the range of natural variability of the past half million years. Model studies anticipate climate change in the coming century well beyond the natural variability of the climate in the past millennia and a possibility of a climate not experienced for tens of millions of years (more than 5°C warming). The past is thus no longer a reliable key to the future and we can expect to meet surprises in our collective journey into Terra Incognita. A precautionary approach is needed and this requires a number of changes in scientific culture and in the way risk assessment is performed. Uncertainty management has to be further improved, vulnerability science should be promoted and a more systematic search for possible surprises and ways to avoid undesired states of the Earth system is needed. Monitoring and empirical research need be enhanced with a special focus on detection and early warning systems, to detect occurrence of possible large-scale instabilities in the climate system in good time. Risk management strategies need to focus on robustness, resilience and disaster preparedness. More realism is needed regarding the role and potential of science in assessing complex risks. There is a need for a greater societal risk management process to cope with and act upon uncertain early warnings. Finally, further development of knowledge partnerships for sustainable development, involving scientists, stakeholders and the public, are crucial in achieving effective climate risk management.

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13. The tension between fiction and precaution in nanotechnology Arie Rip1 The precautionary principle stands midway between a general philosophy of precaution and prudential approaches, and specific legal and regulatory provisions and their implementation. The European Union has taken the lead in articulating such a principle (Commission of the European Communities 2000), and von Schomberg (see chapter 2 in this volume) has offered a comprehensive formulation: Where, following an assessment of available scientific information, there are reasonable grounds for concern for the possibility of adverse effects but scientific uncertainty persists, provisional risk management measures based on a broad cost-benefit analysis whereby priority will be given to human health and the environment, necessary to ensure the chosen high level of protection in the Community and proportionate to this level of protection, may be adopted, pending further scientific information for a more comprehensive risk assessment, without having to wait until the reality and seriousness of those adverse effects become fully apparent [my italics].

Such a precautionary principle is not immediately applicable to nanotechnology. Firstly, nanotechnology is an umbrella term for a range of enabling technologies, rather than a coherent set of processes and products which can be assessed in terms of adverse effects. In this respect, it differs from biotechnology and genomics, with which it tends to be compared in terms of societal impact and public responses. Secondly, it is still quite uncertain which options will be developed and which applications can and will materialize. Nanotechnology is mostly promise, and sometimes pure speculation, as in the case of so-called molecular manufacturing – even while there can be intense debate about such speculative options and the need for precaution. What is ‘reasonable concern’ becomes itself a contested issue. There are some actual applications, like new types of coatings and nanoparticles in sunscreens. For such short-term, well-defined applications one can work with the precautionary principle (if appropriate) in 270

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a relatively straightforward manner. As the discussions about risks of nanoparticles show (DG SANCO 2004, Rathenau Instituut 2004), there is still reluctance to apply the principle and some hedging occurs, even if by now there is sufficient scientific information to indicate the possibility of adverse effects. The report of the Royal Society Working Group (2004), for example, is concerned about gaps in our knowledge of effects of nanoparticles, but emphasizes that there is no need for a moratorium (on the use of synthetic nanoparticles) because there is no ‘incontrovertible demonstration of negative impacts on human health or the environment, although there are some indications (which require further study) that substances in the form of nanoparticles may be more toxic than larger forms’ (Royal Society 2004, p. 77). To counter calls for a moratorium, as in ETC (2003), they are actually willing to revert to a position opposite to the precautionary principle: ‘we will only act when there is incontrovertible evidence’. For the more speculative promises of nanotechnology, it is unclear on what grounds one can and should invoke the precautionary principle: by definition, there is no scientific information about the possibility of adverse effects. Still, there are concerns, and the question is what can be considered to be a reasonable concern in such a situation. There are proposals to be more precautionary, and sometimes doom scenarios are invoked to support such proposals (Joy 2000). The notion of reasonable concern, and the attendant interest in deliberative approaches (von Schomberg, see chapter 2 of this volume), might still be a guideline, but the topic and style of deliberation will be different. One indication is the use of looser terminology: a precautionary philosophy or precautionary approach. The Royal Society Working Group (2004) speaks of a ‘precautionary basis’ and ‘precautionary recommendations’. Another possible entrance point is the stance of actors, which frames attitudes and responses. The cultural theory of Mary Douglas (for example, Douglas and Wildavsky 1982) claims that there are different ‘reasonabilities’ of concerns, depending on the position and context of the actors. A precautionary stance contrasts with a risk-embracing stance, and is itself split up between a risk-averse stance and a regulatory stance (the precautionary principle is then an instance of the latter). Cultural theory helps to explain the nature of the debate, but does not, by itself, offer ways to handle it productively other than that the three main cultural positions or stances should be involved (Schwarz and Thompson 1990). What is happening anyway is that precaution is on the agenda and actors have to come to terms with it. Thus, this chapter will trace ongoing debates in terms of precaution and prudence, and indicate how dimensions and

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issues become articulated. Second, a number of attempts to do better, that is, to improve the combination of fiction and precaution, will be identified. Taken together, this allows a preliminary evaluation of the challenge of nanotechnology for the precautionary principle.

PRUDENCE, RESPONSIBLE INNOVATION AND BURDEN OF PROOF Prudence is visible in two ways: by the ‘enactors’ of nanotechnology who want to safeguard its progress; and by the ‘receptors’ who don’t want to be exposed to, and surprised by, side-effects – or just don’t want to buy into the promises of the ‘enactors’.2 Actually, ‘enactors’ now anticipate the concerns of ‘receptors’, as they see them. Nanotechnologists, when discussing possible impacts and concerns about them, often refer to what happened to GMOs. They want to avoid the impasse about green biotechnology at all costs, and are prepared to take societal concerns and ethical, legal and social aspects on board. Illustrative is the testimony of Vicky Colvin (Rice University) to the US Congress in April 2003 (available on the CBEN website): . . . every new technology brings with it a set of societal and ethical concerns that can rapidly turn ‘wow’ into ‘yuck’. [example of genetic manipulation of crops, public backlash crippling the industry despite the lack of sound scientific data] The failure of the industry to produce and share information with public stakeholders left it ill-equipped to respond to GMO detractors. This industry went, in essence, from ‘wow’ to ‘yuck’ to ‘bankrupt’. There is a powerful lesson here for nanotechnology. In contrast, the Human Genome Project provides a good model for how an emerging technology can defuse potential controversy by addressing it in the public sphere. . . . they wisely welcomed and actively encouraged the debate from the outset by setting aside 5% of the annual budget for a program to define and address the ethical, legal and other societal implications of the project. I sincerely hope that we can learn from this example. . . . In effect, early research into unintended consequences redirects the wow-to-yuck trajectory. . . . We seek to avoid the path traveled by the GMO industry by encouraging the industry to answer the tough questions about societal and environmental impacts while it is still developing. We need partners in this endeavor. Based on the recent National Research Council report and our own experience, there is little money and interest in the societal, ethical and environmental impact of nanotechnology, despite the rhetoric. Your help here is essential. . . . If I had to guess, I would estimate that of the nearly one billion dollars slated to go to nanotechnology this year not even one percent is directed specifically towards studying the societal, ethical and environmental impact of nanotechnology. A tangible symbol of your commitment to this kind of research would be to set a target research funding for the


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area; the 3 to 5% rule used by the Department of Energy in the Human Genome Project would be a good starting point.

In a sense, Vicky Colvin is drawing on a precautionary approach here, but now directed to avoiding harm to the progress of nanotechnology. This is to be realized by including studies about possible impacts. In fact, the USA 21st Century Nanotechnology R&D Act (2003) now includes such provisions. On the side of ‘receptors’, through their putative spokespersons, a debate about moratoriums is emerging for particular areas where nanotechnology might be applied. Examples are calls for a moratorium on production of nanoparticles (because of their health and environmental risks), or on non-medical implants, or on military robots which can kill autonomously (Altmann and Gubrud 2004). Proponents of nanotechnology depict calls for a moratorium as part of a campaign to halt progress (or at least, delay it). This can lead to impasses, as was visible in the responses to ETC’s argument for a moratorium on the release of new nanomaterials (ETC 2003, ETC 2004). But other actors are now adding their voices, in particular the re-insurance company Swiss Re, which recognizes the difficulties of ‘better safe than sorry approaches’, but still says: ‘In view of the dangers to society that could arise out of the establishment of nanotechnology, and given the uncertainty currently prevailing in scientific circles, the precautionary principle should be applied whatever the difficulties’ (Swiss Re 2004, p. 47). Of course, insurance companies have their own, financially motivated, reasons to be prudent, especially with the asbestos history fresh in their minds. In the case of nanoparticles, especially carbon nanoparticles, studies of hazards are now done (and some are published in nanoscience rather than toxicology journals (Borm and Kreyling 2004), which shows how prudence is now seen as an integral part of scientific and technological development). First results indicate that there may well be cause for concern, even if a moratorium, or a temporary moratorium, need not be the proportionate response. For workers at risk, in research laboratories and in the automotive industry, protective measures may be in order. When such measures are introduced, this then legitimates consideration of broader concerns, and calls for further precaution. Clearly, there is a debate, positions are taken, advice is sought and further studies are commissioned. Hopefully, this will lead to further articulation of the issues and insight into how to handle them. The key question is how precaution can function in a debate which is doubly speculative: the future science and technology is still uncertain, let alone the future world in which these may function and have effects.

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Nanoscientists tend to say that nanotechnology is still mostly science fiction, referring to the literary genre of SF in a commonsensical way. In the same vein, one could think of the future worlds as a kind of social science fiction. Definitely, there is an element of fiction involved in offering promises as well as concerns.3 Sometimes, explicit scenarios of future technologies are built and their possible impacts considered. For nanotechnology, there is a range from the more or less concrete to the wildly speculative and contested. For ‘converging technologies’ or NBIC (nanotechnology, biotechnology, information technology and cognitive sciences), speculation, for example about improved human performance, is the central element, especially in USA documents (for example, Roco and Bainbridge 2003). In Europe, there is more restraint (for example, Nordmann 2004). An example of wrestling with this conundrum is how the Center for Responsible Nanotechnology (which is linked to Drexler’s Foresight Institute) focuses on molecular manufacturing, in particular the risks associated with tiny, foraging, self-replicating systems – the ‘gray goo’ scenario which is referred to in popular publications and has come alive in fiction, in Michael Crichton’s Prey (2002). Phoenix and Treder (2004), after noting that ‘at this point, science does not have sufficient information to rule on the likelihood or even the theoretical possibility of such a risk’, say: ‘This is the sort of case that the precautionary principle was designed for’. As it turns out, however, they are not able to apply whatever the principle was they had in mind (definitely not the European Union version), but are forced to talk in terms of general strategies towards the unknown. They distinguish what they call the strict form which requires inaction when action might pose a risk, and an active form, where inaction is considered to have problems as well (in particular, forgoing possible benefits) and the strategy is to act, but search for less risky alternatives and take responsibility for potential risk. They propose to do so by having only one development programme with strict conditions to minimize risks, but broad access to the resulting manufacturing capabilities. This example shows the difficulty, in the case of speculative developments, of progressing beyond the general strategies which have been discussed for decades, in particular in relation to environmental harm. Mary Douglas’s cultural theory helped us to understand the social location of the strategies of excluding risk by prohibition of certain actions (the strict version of precaution), the rule-based approach, and the embracing of risk as an opportunity for learning. The Center for Responsible Nanotechnology’s approach is to accept the risk and go forward, but in a responsible manner. The difficult questions come after: is it possible to contain risks, and how exactly should that be done? The Center for Responsible Nanotechnology’s


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argument appears to be that further work cannot be stopped anyhow, so better try to do it in a responsible way. It positions itself (and is able to create a living that way) between the extreme of condemnation of all attempts at hindering what is considered to be progress, and the contrary position of avoiding all possible risks. Spaces for such positions appear to emerge. The ETC group, when they argue that one should try to learn as much as possible about possible harm and benefit before one commits oneself to action with possibly irreversible effects, can be seen as occupying part of such a middle ground as well. Greenpeace UK (Arnall 2003) recognizes the value of new technologies, but wants their progress to be subjected to democratic control. From the side of the ‘enactors’, there is interest in ‘responsible innovation’. It has become an important concept in high-level meetings (even if it is not quite clear what it will imply for ongoing research and product development). On the initiative of Mihail C. Roco, who leads the US National Nanotechnology Initiative, a meeting was convened in Alexandria, VA, 17–18 June 2004, of high-level officials and scientists from countries all over the world, to discuss international dialogue on responsible research and development of nanotechnology. (A report was drawn up by the Meridian Institute, see www.merid.org.) The European Commission indicated its interest in pursuing such a dialogue. In its recently published action plan, Looking small, thinking big – keeping Europe at the forefront of nanotechnology, it says, according to the press release: ‘The European Commission has today [13 June 2005] announced the ways in which it intends to keep Europe at the forefront of the fast-moving field of nanotechnology in a safe and responsible way’. At the level of ongoing nanoscience and nanotechnology, one sees initiatives (induced by credibility considerations, but nonetheless real) to include consideration of ethical, legal and social aspects (ELSA), as in the Ethics Boards of European Union Networks of Excellence, and in national nano-consortia (in the Netherlands) and nano-research centres (as in Cambridge, UK). It is not yet clear what the eventual effects will be on ongoing research and product and process development. But it is clear that such attempts to earn a licence to research or produce will introduce precautionary approaches, even if there is no precautionary principle involved. The notion of ‘responsible innovation’ is important, but should not be seen as an attempt to create harmony. The situation is one of struggle and of force being exerted to push one or the other position. Deliberative approaches can help to articulate positions and support interaction, but will not create a consensus. In other words, struggle is unavoidable, but through the contestation, some learning can occur (Rip 1986). In these

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struggles, invocation of a precautionary approach shifts the balance of forces. As von Schomberg (see chapter 2, this volume) notes for the precautionary principle: if it is accepted as applicable, then the activity under consideration is defined as potentially hazardous, and the burden of proof (that is, proof of innocence) is shifted to the promotors of the activity.4 Naturally, such a shift will be resisted, and one will hear declarations of innocence. For chemicals, this pattern was visible in the 1970s and 1980s, but by the 1990s, innocence had been lost, regulations were in place, and the chemical industry itself had created its Sustainable Care programme (now succeeded by People, Planet, Profit). While in the European Union, by now, invocation of the precautionary principle is guided by the normative qualifier used in the EC guidelines on the PP, ‘reasonable grounds for concern’ (the grounds are scientifically informed: nature and extent of uncertainties and so on), in the case of promises and concerns about nanotechnology, the whole idea of what would be ‘reasonable grounds’ is still unclear. In a sense, the lack of clarity is structural, because of the combination of science fiction and social science fiction: one might well find the concern about a ‘grey goo’ scenario reasonable, but what if this is just science fiction? And how does one know whether this is indeed impossible, so ‘just’ science fiction? The struggle about the burden of proof thus shifts from the question of possible harm, or adverse effects, as with chemicals, to the question of plausibility of future scientific and technological achievements. Possible, and possibly reasonable, concerns about nanotechnology are counteracted by declaring the underlying, and assumed, scientific and technological achievements impossible. This is what happens around molecular manufacturing (molecular assemblers), which are linked to ‘grey goo’ scenarios. Indicative is the response to a clause in the USA 21st Century Nanotechnology R&D Act (section 5b and c) where the National Research Council was asked to study the technical possibility of ‘molecular self-assembly’ and to consider how ‘responsible development’ of nanotechnology could be guaranteed, in particular for ‘self-replicating nanoscale machines or devices & the release of such machines in natural environments’. Many mainstream nanotechnologists interpreted the latter phrase as suggesting that the USA Congress saw such a development as possible, and thus a support for the Drexlerian vision of nanotechnology (Drexler and Smalley 2003); they not only disagreed with this, but wanted to contest it, up to allegations of wheeling and dealing with members of Congress (see TNT Weekly, 28 November 2003). This is part of a second-order struggle: if self-replicating nano-devices were possible, the concerns about their risks would be legitimate, and would


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justify limitations on R&D nanoscience and technology. Instead of declaring innocence, the nanotechnologists have to declare impossibility, at least for some of the developments that are discussed. Such second-order struggles are typical, and in fact unavoidable, for new and emerging science and technology.

TURNING THE STRUGGLES INTO PRODUCTIVE LEARNING AND ACTION The challenge is to develop a precautionary approach (and perhaps an articulated addition to the precautionary principle) which is productive in this world of science fiction and social science fiction. A precautionary approach will always involve scoping of future developments, and thus implicit or explicit scenario building. In the present European Union approach, the scenarios are about the possible adverse effects, and about the cause for concern and the extent of measures (proportionality). This assumes that the technology, as well as the dimensions of uncertainty about adverse impacts, are more or less known. The extent of uncertainty is then addressed in a precautionary manner. Sometimes, new dimensions of uncertainty may be included, for example the effect of combined exposure to contaminants. For nanotechnology, this approach to precaution is not sufficient. Instead of uncertainty, the scenarios must now address ignorance, and explore the future with the help of science fiction and social science fiction. Within this overall, and programmatic approach, a number of specific entrance points can be identified. An important prior step is to disaggregate nanotechnology: discuss molecular manufacturing separately from transplants and human enhancement, and from nano-electronics, and from nanoparticles. It is intriguing that mobilization of funds and other support for the promise of nanotechnology builds on the rhetorical force of the umbrella term, while such a consolidated approach will then also imply that risks and concerns about one particular domain of application ‘infect’ other domains: if it is ‘nano’, it must be bad. Such a global condemnation (as has occurred for green biotech) is not the case yet, but nanotech actors are concerned that it might happen.5 Exposure Scenarios While the second-order struggles become less diffuse when applications are more concrete, they do not disappear. For nanoparticles, there are an

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increasing number of concrete applications, and risk assessment is taken up seriously. Toxicological and epidemiological studies are being done, and the question, how much new regulation is in order, is asked (see Royal Society 2004). A key issue is that size, and size distribution, are not part of the present regulatory regime for noxious substances. What is neglected in these studies and debates, are the actual exposure scenarios: which exposures (and for which size distribution) can be expected. This depends on the uptake and diffusion of the new technologies and products, which are still speculative. Still, for nanoparticles, a precautionary approach is relatively easy. There is in fact scientific data on the effect of size: partly because nanosized particles occurred already (in soot, in aerosols) before they were intentionally produced, and partly because of the recent concerns which led to dedicated further studies. Present regulation is in terms of concentrations, and to include size effects further measurement techniques must be developed (compare Rathenau Instituut 2004 and DG SANCO 2004). The Royal Society Working Group (2004, p. 71) offered a creative recommendation: consider nanoparticles not as smaller-size versions of existing substances, but as new substances so that they can be treated under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. Interestingly, the quandary that was visible for nanotechnology in general (big promises generate big concerns), returns in a specific version for nanoparticles: ‘size matters’ constitutes the promise of special performance in applying nanoparticles, but the same phrase indicates that health and environmental effects will depend on the size of the particles. The general message is twofold. First, the tension between the promise of new phenomena and effects, and the possibilities of new and possibly negative effects should be recognized and addressed, for example through studies of possible effects. Second, such studies should be complemented by constructing and checking exposure scenarios. A simple example, already being discussed, is the difference between nanoparticles embedded in materials and therefore ‘safe’, and nanoparticles in the ambient air. Precaution must focus on actual exposure, rather than criminalize a component or product per se. Depth of Intervention An interesting even if still programmatic approach is to shift from doubly speculative impact assessments to characterization of the nature of the technology, particularly its actual or envisaged ‘depth of intervention’ (Haum et al. 2004, Nill and Petschow 2004). There is a precedent in the way


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recombinant DNA research and genetic modification have been regulated: the larger the distance between inserted DNA and its host organism, the stronger the presumption that there is a larger risk, and thus a more strict regulatory regime. The clause on reasonable concern following an assessment of available scientific information will take on a new meaning: the ‘information’ now regards an assessment of changes with respect to the present set-up, for example, from limited structural changes to changes in reactivity and catalytical effects, to quantum effects. The larger the change, the more reasonable is the concern. Haum et al. (2004) list specific considerations and approaches. For nanotechnology in general, depth of intervention is linked to broad promises, like a third industrial revolution. Scepticism of such promises may be in order – another form of precaution, to avoid investment in forlorn options. Here, the point is that the promise of new and powerful functionalities enabled by nanotechnologies should be checked on depth of intervention. It is exactly the promise of new functionalities which justifies a cause for concern. Storylines, Learning and Action In general, scenarios create a microcosm, and plausibility of that microcosmic ‘world’ is just as important as detailed considerations of uncertainty. Within such a world, one can then do a virtual exercise of mapping and ‘early’ identification of possible adverse effects, which could lead to the invocation of a precautionary approach. One can try to improve the scenario building, but the key point is how such scenarios link to the world of action. This may provide early warning, but the lessons are often learned after something has gone wrong (Harremoës et al. 2001). It is important to locate the scenario building in the whole range of diffuse and only partly articulated anticipations and scenarios that various actors work with. This is also where story telling becomes important. Different actors will develop different (diffuse or articulated) scenarios, depending on their interest in ‘enacting’ a new technology, or respond to a new technology by selectively comparing it with other options (Garud and Ahlstrom 1997). ‘Bridging events’ between the ‘enactors’ and ‘comparative selectors’ (Rip 2004), are important loci for articulating the nature and possibilities of such interactions. Supporting and orchestrating such ‘bridging events’ then becomes just as important as the improvement of one or another scenario as such. Story telling will always be involved (which is important in social and economic life, and in our culture in general anyway). One striking example

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is the force of the storyline of a ‘runaway’ nuclear reactor, of ‘runaway’ GMOs, now of ‘runaway’ nanoswarms as in Crichton’s SF novel (Rip and Talma 1998). The general idea of ‘storyline’ has been shown to be an important driver in policy articulation and implementation (Hajer 1995), and it is clearly useful to understand the link between the diffuse struggles and the eventual precautionary action. An example would be how in 1974–1976 measures to reduce the use of fluorochlorocarbons in spray cans were put in place after the early warning about the ozone layer (Dotto and Schiff 1978): the archetypal story of Icarus and his fall after flying too close to the sun reinforced the argument for precautionary measures even before measurements had shown reduction of the ozone layer. Storylines function as part of our culture, but when they are (made) explicit, they can also set in motion attempts to corroborate or to undermine them. Then they become ‘hypotheses’ in a collective, distributed (and agonistic) attempt at learning (Rip 1986, 2001). Governance of New and Emerging Science and Technology In relation to nanotechnology there is implicit or embedded governance, for example when the notion of responsible innovation starts to make a difference in what actors do and do not do. Dominant storylines in our culture have effects in that they attribute roles and responsibilities. At an earlier stage, Greenpeace has profited from its being seen to play David against the Goliath of multinational companies and government establishments. Governance can be made explicit, and in a broader way than through government regulation, for example, through publicly announced selfrestraint, as happened with recombinant DNA research after the 1975 Asilomar meeting. There are no such initiatives visible for nanotechnology, and it is not clear whether there is occasion to consider self-restraint. But there may be governance reasons: showing that self-regulation is possible and will improve trust in scientists and technologists. I have actually suggested a moratorium for a special area of nanotechnology (in my submission to the Royal Society Working Group 2004). Not necessarily because of adverse effects linked to that area, but for symbolic reasons, to show that nanotechnologists and regulators are prepared to consider a moratorium seriously. This then could defuse a possible impasse between proponents and opponents of nanotechnology push. It would also indicate that a moratorium is a governance instrument, not a halt to progress. And in fact, it can be set up in such a way that learning practices can continue.


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IN CONCLUSION There are two types of conclusion: about nanotechnology and precaution, and about precaution in the case of new and emerging technologies. The doubly speculative character of the development and impact of nanotechnology is clear, but it is also clear that actors are now starting to discuss precaution and are attempting to come to terms with the challenges. I have described the interactions and struggles, and shown that there are building blocks for precautionary approaches even when the precautionary principle cannot be applied directly. One interesting feature is how prudence leads nanotechnologists and government actors to consider social and ethical aspects at an early stage of development: a precaution to ensure continued progress of nanotechnology turns into (some) precaution applied to nanotechnology. The issues and struggles about nanotechnology are important in their own right. In this chapter, I have used them to discuss possibilities and limitations of precautionary approaches. In particular, to show that there are possibilities for precautionary approaches even when the precautionary principle cannot handle speculative technologies like nanotechnology (where there is ignorance, not just uncertainty). Looking back at the items I presented above, it is clear that they will work, in the sense of being taken up in an appropriate manner and having some effect, if there are governance patterns backing them up. ‘Soft governance’has been put forward as a possibility(Nill and Petschow 2004). It will be particularly interesting to – critically and constructively – follow the move towards responsible innovation.

NOTES 1. Acknowledgement: I am grateful to René von Schomberg and an anonymous reviewer for constructive comments. 2. The terminology ‘enactors’ and the complement ‘receptors’ is inspired by Garud and Ahlstrom (1997), as further developed by Arie Rip (2004). In these analyses, ‘comparative selectors’ is used rather than ‘receptors’ to emphasize their independent status and possibility of rejecting a technological option in favour of an alternative. 3. Actors can play on the fictional elements. IBM’s Almaden Research Center starts its website with the phrase ‘Working towards the magic of tomorrow’s technology’. This refers to a quote from SF writer Arthur C. Clarke, featured at the bottom of the page: ‘Any sufficiently advanced technology is indistinguishable from magic’. 4. In the Communication of the Commission of the European Communities on the Precautionary Principle (2000), the shift in the burden of proof is emphasized, but not positioned as a general rule (section 6.4): ‘Action taken under the head of the precautionary principle must in certain cases include a clause reversing the burden of proof and placing it on the producer, manufacturer or importer, but such an obligation cannot be systematically entertained as a general principle’. 5. Tim Harper has reported on the rise of nano as a label that helps mobilize resources, including interest of customers. He now also signals (TNT log 27 May 2005)

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Prospective applications of the precautionary principle that some firms are dropping the reference to nano in their products and their PR documents.

REFERENCES Altmann, J. and M.A. Gubrud (2004), ‘Military arms control and security aspects of nanotechnology’, in Davis Baird, Alfred Nordmann and Joachim Schummer (eds), Discovering the Nanoscale, Amsterdam: IOS Press, pp. 269–77. Arnall, A.H. (2003), Future Technologies, Today’s Choices: Nanotechnology, Artificial Intelligence and Robotics – A Technical, Political and Institutional Map of Emerging Technologies, London: Greenpeace Environmental Trust. Borm, P.J.A. and W. Kreyling (2004), ‘Toxicological hazards of inhaled nanoparticles: potential implications for drug delivery’, Journal of Nanoscience and Nanotechnology, 4, 1–11. Commission of the European Communities (2000), Communication from the Commission on the Precautionary Principle, com 2000/001, Brussels, 2 February. Crichton, Michael (2002), Prey, New York: Harper & Collins. DG SANCO (2004), Risk and Nanotechnology, March 1–2, 2004, Workshop, Brussels: European Commission, DG Sanco, papers presented (unpublished). Dotto, Lydia and Harold Schiff (1978), The Ozone War, New York: Doubleday. Douglas, Mary and Aron Wildavsky (1982), Risk and Culture: An Essay on the Selection of Technological and Environmental Dangers, Berkeley, California: University of California Press. Drexler, E.K. and R. Smalley (2003), ‘Nanotechnology: Drexler and Smalley make the case for and against “molecular assemblers” ’, Chemical & Engineering News 81 (48), December, 37–42. ETC (2003), No Small Matter II: The Case for a Global Moratorium – Size Matters!, Occasional Paper Series, 7 (1), available at http://www.etcgroup.org/documents// Occ.Paper_Nanosafety.pdf (accessed 22 October 2005). ETC (2004), Nano’s Troubled Waters, 1 April, available at http://www.etcgroup.org/ article.asp?neusid=445. Garud, Raghu and David Ahlstrom (1997), ‘Technology assessment: a sociocognitive perspective’, Journal of Engineering and Technology Management, 14, 25–48. Hajer, M.A. (1995), The Politics of Environmental Discourse: Ecological Modernization and the Policy Process, Oxford: Clarendon Press. Harremoës, P., D. Gee, M. Mac Garvin, A. Stirling, J. Keys, B. Wynne and S. Guedes Vaz (eds) (2001), Late Lessons From Early Warnings: The Precautionary Principle 1896–2000, Copenhagen: European Environmental Agency. Haum, Rüdiger, Ulrich Petschow, Michael Steinfeldt and Arnim von Gleich (2004), Nanotechnology and Regulation within the Framework of the Precautionary principle, Berlin: Institut für ökologische Wirtschaftsforschung. Report prepared for the Committee on Industry, Technology, Research and Energy of the European Parliament, February. Joy, Bill (2000), ‘Why the future doesn’t need us’, Wired, 8 (4), 238–62. McCray, W. Patrick (2005), ‘Will small be beautiful? Making policies for our nanotech future’, History and Technology, 21 (2), June, 177–203.


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Nill, Jan and Ulrich Petschow (2004), ‘The precautionary principle and nanotechnologies’, paper presented to the European Workshop on Social and Economic Research on Nanotechnologies and Nanosciences, Brussels, 14–15 April. Nordmann, Alfred (rapporteur) (2004), Converging Technologies: Shaping the Future of European Societies, the Report of the High Level Expert Group ‘Foresighting the New Technology Wave’, Luxembourg: European Communities. Phoenix, Chris and Mike Treder (2004), Applying the Precautionary Principle to Nanotechnology, January, available at http://www.crnano.org/precautionary.htm (accessed 22 October 2005). Rathenau Instituut (2004), Verslaglegging Workshop: Kansen en Risico’s van Nanodeeltjes, Den Haag, 17 februari 2004, Den Haag: Rathenau Instituut. Rip, Arie (1986), ‘Controversies as informal technology assessment’, Knowledge, 8 (2), 349–71. Rip, Arie (2001), ‘Contributions from social studies of science and constructive technology assessment’, in Andrew Stirling (ed.), On Science and Precaution in the Management of Technological Risk. Volume II: Case Studies, Sevilla: Institute for Prospective Technology Studies (European Commission Joint Research Centre), November, pp. 94–122. Rip, Arie (2004), ‘Articulating images, attitudes and views of nanotechnology: enactors and comparative selectors’, paper presented at the European Workshop on Social and Economic Research on Nanotechnologies and Nanosciences, Brussels, 14–15 April. Rip, Arie and Siebe Talma (1998), ‘Antagonistic patterns and new technologies’, in C. Disco and B.J.R. van der Meulen (eds), Getting New Technologies Together, Berlin: Walter de Gruyter, pp. 285–306. Roco, Mihail C. and William S. Bainbridge (eds) (2003), Converging Technologies for Improving Human Performance: Nanotechnology, Biotechnology, Information Technology and Cognitive Science, Dordrecht: Kluwer. Royal Society (2004), Nanoscience and Nanotechnologies: Opportunities and Uncertainties, RS Policy Document 19/04, London: The Royal Society. Schwarz, Michiel and Michael Thompson (1990), Divided We Stand: Redefining Politics, Technology and Social Choice, Hemel Hempstead: Harvester Wheatsheaf. Swiss Re (May 2004), Nanotechnology: Small Matter, Many Unknowns, Zürich: Swiss Re. USA 21st Century Nanotechnology R&D Act (2003), 108th US Congress, First Session, S.189.

14. A framework for the precautionary governance of food safety: integrating science and participation in the social appraisal of risk Andy Stirling, Ortwin Renn and Patrick van Zwanenberg1 1.

INTRODUCTION

The precautionary principle has been adopted in a variety of forms at international, European Union and national levels (Fisher, 2002). It is applied across an increasing number of national jurisdictions, economic sectors and environmental areas (Trouwborst, 2002; de Sadeleer, 2002). It has moved from the regulation of industry, technology and health risk, to the wider governance of science, innovation and trade (O’Riordan and Cameron, 1994; Raffensperger and Tickner, 1999; Harding and Fisher, 1999; O’Riordan et al., 2001). As it has expanded in scope, so it has grown in profile and authority. In particular, at a European level, the precautionary principle is explicitly laid down as a guiding principle of EC environmental policy (Article 174 (2) of the EC Treaty) and recognized both by the European Court of Justice (for example, ECJ 1998) and the European Commission (Commission of the European Communities, 2000) to be a general principle of EC law. In the aftermath of a series of formative public health controversies, economic calamities and political conflicts (such as those involving BSE and GM crops), precaution is nowhere of greater salience or importance than in the field of food safety (van Zwanenberg and Millstone, 2005). Despite the intensity of the policy attention, however, there remain a number of serious ambiguities and queries concerning the nature and appropriate role of the precautionary principle in governance (Cross, 1996; Morris, 2000; Stone, 2001; Majone, 2002; Marchant and Mossman, 2004). These are addressed – if not resolved – in a burgeoning literature which is both academic (Sand, 2000; Fisher, 2001; Renn and Klinke, 2001; Stirling, 284

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2003a; van Zwanenberg and Stirling, 2004) and more policy-oriented (Stirling, 1999a; Harremoës et al., 2001; Renn et al., 2003). In focusing on the particular case of food safety as an illustration of these general challenges, the present chapter will engage with a series of intractable questions. First, does the precautionary principle bear exclusively on the ‘taking of decisions’ in governance, or does it also have implications for the processes of appraisal that inform such decision making? Second, is the precautionary principle best understood as a substantive ‘decision rule’, or more procedurally, as a principle informing the design of a governance process without necessarily prescribing its outcome? Third (and in either event), there is the question of how the precautionary principle relates to parallel (and sometimes contending) principles of good governance, such as proportionality and non-discrimination, transparency and public reason, accountability and effectiveness (Fisher, 2003). Much of the academic discussion on these matters takes the form of sophisticated (but sometimes divergent, open-ended and discipline-specific) critical commentary and analysis. Official policy documents, on the other hand, focus on ostensibly clear and operational (but sometimes rather simplistic, circumscribed and closed) formulations of the precautionary principle. Given the resulting ambiguities, tensions and conflicts it may be unfeasible (and potentially misleading) to seek a single, uniquely authoritative, universally applicable or uncontroversially appealing ‘model’ of precaution in governance. On the other hand, there does seem to be some relatively under-realized complementary value in efforts to develop broadly operational policy frameworks, which embody attention to a full range of issues and complexities raised in the academic literature. Accordingly, the present chapter reports on collaborative ‘work in progress’ of just this type. It is based on the findings of a series of policyoriented research projects, funded by European Commission bodies, but involving interaction with diverse disciplinary and stakeholder groups (Stirling, 1999a; Harremoës et al., 2001; Renn et al., 2003; Dreyer and Renn, 2005). The focus of attention is a possible ‘general framework’ for the implementation of precaution in the governance of technological risk. This will be discussed for the purpose of illustration, with particular attention to the field of food safety. In setting out this framework, the intention is not to claim some uniquely complete, robust or final status. The purpose is rather to offer a concrete basis for dealing systematically with the intractable questions raised above. The idea is to develop a framework, which at the same time spans the gap between the ambiguities and complexities of academic analysis and the contending simplifications and polarizations of policy debates. It is in this way that this type of interactive, action-oriented policy research may hope to make a significant contribution to developing useful

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practical responses to the profound and far reaching challenges of precaution in governance.

2. SOME KEY DEFINITIONS: GOVERNANCE, APPRAISAL, PRECAUTION AND RISK The precautionary principle was introduced in the previous section in terms of some key general challenges that are presented for governance (Commission of the European Communities, 2001). As will be discussed further below, the term governance for present purposes describes structures and processes for collective decision making involving both governmental and non-governmental actors (Nye and Donahue, 2000). In order to examine these challenges in more detail, it is helpful to focus more specifically on one particular area – in this case food safety. Among other things, this permits the development of a series of precise working definitions. These will be used later in discussing the proposed framework for precautionary governance of food safety. Each of the defined terms is indicated on first use here with italics. In food safety, as in other areas of risk regulation, the process of risk analysis is held under internationally recognized terminology to involve three subordinate elements (Codex, 2001). Risk assessment is defined as a ‘science-based’ process, using quantitative techniques where possible to characterize hazards, model dose-response relationships and measure exposures. Risk management is held to be distinct from risk assessment, in that it involves the process of decision making itself, introducing nonscientific considerations beyond risk assessment, such as levels of protection, selection of instruments, alternative policies and the associated wider benefits, costs and evaluations of different parties. The third element, risk communication, involves the interactive exchange of information, both within and beyond risk analysis as a whole, with an emphasis on ‘the explanation of risk assessment findings and the basis of risk management decisions’ (Codex, 2001). Conceived in this way, the entire business of risk analysis forms just one – albeit important – part of the wider process of risk governance. Alongside matters of assessment, management and communication, risk governance extends to issues of institutional design, legislative procedure, consultative style, organizational culture, expert accreditation, methodology choice, political accountability, stakeholder negotiation, conflict resolution and the exercise of power. It applies equally to the activities of private, commercial and civil society organizations as to public sector bodies, and emerges as much from the relationships between such actors as from their


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individual attributes. As such, governance also includes more general features of social and institutional networks – for building and using scientific knowledge, for developing innovation and technical competences, for fostering efficiency and competitive strategies, for establishing legitimacy and competence and for promoting social and organizational learning (Nye and Donahue, 2000). Risk governance is thus broader than – and entirely subsumes – the business of risk analysis. The concrete implications will be returned to in the final section of this chapter. Whether explicit or implicit, a key element in the broad process of risk governance lies in the appraisal of alternative technology, strategy or policy options. It is appraisal that informs, substantiates and justifies subsequent governance decisions and commitments. The more technical aspects of this appraisal function are conventionally delivered by ‘science based’ risk assessment. This uses probabilistic concepts and methods to help narrow down the complexities, ambiguities and uncertainties encountered in appraisal, into a neatly tractable form, of a kind that can then provide ready justification in decision making (Stirling, 2003a, 2004). It is in these terms that much policy discussion of the precautionary principle – including key documentation produced by the European Commission – holds the precautionary principle to apply not to the ‘sound scientific’ procedures of risk assessment, but to what is held to be the more broad based and judgemental business of risk management (Commission of the European Communities, 2000). There can be no doubting the elegance and facility of these kinds of ‘science based’ risk assessment techniques across an array of different conditions. It is clear that the precautionary principle is of considerable importance in risk management. However, what is of particular relevance in considering the relationship with risk assessment, is that the precautionary principle also holds a number of crucial implications for the process of appraisal. This stems from recognition of the way in which a series of distinct forms of incertitude present rather different challenges to the more tractable and readily quantifiable forms of risk addressed in risk assessment (Tickner, 1999; Stirling, 1999a, 2003a). Figure 14.1 presents a schematic illustration of the way in which incertitude presents a range of challenges beyond the condition of risk. In these terms, the formal scientific definition of risk is described in the top left corner, where there is an ability fully to characterize the different possibilities and confidently to determine their relative likelihoods. The strict definition of the state of uncertainty, by contrast, is that it is a condition under which the possible outcomes are clear (such as specific types or degrees of harm or benefit), but where it is difficult to quantify probabilities (Knight, 1921; Keynes, 1921; Luce and Raiffa, 1957; Morgan et al., 1990; Funtowicz and Ravetz, 1990). A condition of ambiguity emerges where the problem lies not

288

e.g.: many carcinogens floods under climate change shareholder value

UNCERTAINTY

e.g.: routine floods transport safety known diseases

RISK

not problematic

e.g.: BSE CFCs and the ozone hole endocrine disruption

IGNORANCE

e.g.: greenhouse scenarios energy impacts concept of GM harm

AMBIGUITY

problematic

KNOWLEDGE ABOUT POSSIBILITIES

Beyond risk: a series of further intractable ‘degrees of incertitude’ and examples

After Stirling (2003b).

Figure 14.1

Source:

problematic

not problematic

KNOWLEDGE ABOUT LIKELIHOODS


289

with probabilities, but in agreeing the appropriate questions to ask, values to adopt, priorities to assign, or limits to impose in the definition of the possible outcomes themselves (Thomson and Warburton, 1985; Wynne, 1992, 2002; Rosenberg, 1996; Renn, 1999; Stirling, 1999b; forthcoming; Renn and Klinke, 2001). Ambiguity may thus prevail over the meaning, prioritization or bounding of outcomes, even where there is no question of uncertainty in relation to their likelihood. Finally, a condition of ignorance exists where neither probabilities nor outcomes may be fully or confidently characterized. In this latter case, where ‘we don’t know what we don’t know’, we are exposed to the perennial prospect of ‘surprise’ (Keynes, 1921; Loasby, 1976; Collingridge, 1982; Ravetz, 1986; Smithson, 1989; Wynne, 1992; Faber and Proops, 1994; Stirling, 1999b). Each of these ‘degrees of incertitude’ may exist simultaneously in any given practical context. And each may be variously subdivided according to different sources, methodological implications or locations at different stages in the process of appraisal (van Asselt, 2000; Stirling, 2003a). For this reason, it may help avoid confusion to employ the term ‘risk’ (where possible) only in the established strict sense of this word. To avoid coining neologisms, the colloquial term threat – as used, for instance, in the classic enunciation of the precautionary principle in the Rio Declaration (UNCED, 1992) – may offer a more clear and consistent way to refer to individual products or industrial processes, specific features of which may exhibit forms of incertitude beyond mere risk. This will be the convention in the present chapter, when turning later to the development of a systematic framework for the governance of food safety. Given this wider and deeper picture of incertitude, prompted by consideration of the precautionary principle, it becomes clear that there exist a variety of approaches to appraisal beyond conventional risk assessment. Depending on the circumstances, these might include various forms of technology assessment, decision analysis and ‘extended foresight’, including sensitivity, scenario analysis and ‘multi-criteria mapping’, as well as a variety of approaches to transdisciplinary deliberation, stakeholder engagement and citizen participation (Renn, 2004; Stirling, forthcoming). Some of these approaches share with ‘science based’ risk assessment the properties of narrowing down the appraisal through procedures of quantification, reduction and aggregation. Others are much more broadbased, permitting the inclusion in appraisal of a wider array of qualitative, indirect and ‘non-scientific’ factors and a more explicit and flexible treatment of the way in which subjective values and contingent framing assumptions can determine very different appraisal results. Accordingly, it is clear that the precautionary principle is of relevance not only to the management, but also to the assessment of risk.

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3. PRACTICAL CHALLENGES: INFORMING A FRAMEWORK FOR PRECAUTIONARY GOVERNANCE In the light of the preceding analysis, excessive reliance on conventional risk assessment can seem to reflect a rather narrow, optimistic or expedient view of the depth and form of knowledge that is necessary in appraisal (Tickner, 1999; Stirling, 1999a, 1999b, 2003a; Harremoës et al., 2001). At the same time, however, recourse to more broad-based ‘precautionary’ approaches to appraisal can also bring its own problems. To some, precaution can appear unduly pessimistic about the quality of the available knowledge (Morris, 2000). In particular there can be a lack of clarity over the ‘triggering’ of precaution and the consequent procedures may sometimes seem fuzzy, onerous or exaggerated in their impacts (Sand, 2000). Among other things, these can raise governance challenges over the way in which the precautionary principle is articulated with risk assessment in appraisal. In an industrial sector that is as large and globally pervasive as food production and distribution, these challenges introduce high political, economic and institutional stakes. Each side of the risk assessment/precautionary principle contrast therefore comes to be represented in very different ways by contending actors. The general effect of this is to compound the prevailing state of confusion, polarization and conflict over the appropriate approaches to appraisal. Yet, despite the complexities, the central governance challenge seems quite clear. In short, there lies a compelling imperative to develop a clear and consistent framework for the articulation of both risk assessment and the precautionary principle in appraisal. First (and foremost), any such integrated framework must address accepted principles of good governance. Reflecting complex political and academic discourses on these matters, the European Commission has identified five such general normative principles in its White Paper on Governance (Commission of the European Communities, 2001). Among other areas, these apply particularly to the governance of food safety (Commission of the European Communities, 1999). Although not unproblematic (Joerges et al., 2002; Fisher, 2004), these provide a practical operational basis for a deliberately policy oriented initiative, such as the normative framework that will be proposed here. The European Commission’s principle of openness entails clear, accessible communication of the rationale for decisions and other governance outcomes. Participation requires governance institutions actively to engage with other social groups, from the conception of strategic options right through to the implementation of decisions. Accountability involves clarity over the nature of the


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reasoning and the allocation of responsibility in legislative and executive processes. Effectiveness relates to issues of subsidiarity, and to timeliness and proportionality in decision outcomes. This in turn relates to issues of ‘non discrimination’, which – though (curiously) not explicitly referred to in the White Paper – are elsewhere emphasized strongly by the European Commission, especially with regard to the governance of food safety (Commission of the European Communities, 1999). Coherence concerns the degree of consistency that can be achieved by complex institutional frameworks in addressing even more complex technical, social and natural systems. Each of these principles accompanies the precautionary principle itself, as a central consideration in evaluating any candidate framework for the governance of risk. Second (and to this end), it is clear that compliance with these governance criteria requires a high degree of specificity over the way in which an appropriate balance may be struck between the roles played by different economic interests and public constituencies, specialist disciplines, technical procedures, institutional designs and modes of engagement. In particular, this involves an associated duty explicitly to state the reasons why particular courses of action are favoured over others. Third, in the light of the preceding conceptual discussion, we may now determine more specifically that these governance criteria also require of any framework that it address in a deliberately targeted fashion, the distinct challenges of ‘risk’, ‘complexity’, ‘uncertainty’, ambiguity’ and ‘ignorance’. Taken together, identification of these challenges helps provide a transparent basis for evaluative conclusions over the degree to which the framework developed here successfully addresses the principles of good governance and associated issues raised in the last section. As such, they will be returned to at the end of this chapter, after the ensuing discussion of the framework itself.

4. A GENERAL FRAMEWORK FOR THE PRECAUTIONARY GOVERNANCE OF FOOD SAFETY Overview It now remains to discuss in detail a particular illustrative framework for addressing these challenges in the governance of food safety. Accordingly, Figure 14.2 presents a schematic representation of a general architecture comprising three distinct aspects: screening, appraisal and management (Stirling and van Zwanenberg, 2003). These broadly correspond with the familiar stages in the conventional process of risk analysis described

292 no

yes

yes

yes

yes

APPRAISAL

STANDARD RISK ASSESSMENT

DISCURSIVE PROCESS

EXTENDED RISK ASSESSMENT

PRECAUTIONARY APPRAISAL

PRESUMPTION OF PREVENTION

A general framework for the precautionary governance of food safety

Stirling and van Zwanenberg (2003).

Figure 14.2

Source:

is the threat ambiguous?

is the threat complex or large in scale?

is the threat scientifically uncertain?

SCREENING

no

Is there definitely a serious threat?

DESIGN, DEVELOPMENT AND OVERSIGHT

EVALUATION

MANAGEMENT

UNRESTRICTED ACTIVITY

INSTRUMENTS

MANAGEMENT

OF

RANGE

PREVENTIVE MEASURES


293

earlier, with the different terminology used here reflecting the extension of scope required in order to address the issues listed in the previous section. Each step is summarized here before more detailed discussion in the following subsections. The first step is a process of screening. This applies governance principles such as openness and effectiveness, as well as precaution, in order to characterize key features of different threats. The purpose of that characterization is to identify the most appropriate form of subsequent appraisal in each case. The second step is appraisal itself. Essentially, this reflects a broader understanding of the function conventionally fulfilled by risk assessment. Again governance principles such as effectiveness and coherence, as well as precaution, dictate that different aspects of a threat (such as uncertainty and ambiguity) are appropriately addressed by a wider portfolio of appraisal tools than just risk assessment alone. The third step is management. This corresponds closely to conventional understandings of risk management, involving the evaluation of the outcomes of appraisal and the taking of explicit decisions over levels of protection and appropriate instruments. The major difference is that decisions are informed by wider processes of appraisal than risk assessment alone. It should be emphasized that what is conventionally recognized as a single separate task of risk communication in risk analysis, is incorporated in this framework as an intrinsic feature of the process. As indicated by the interlinkages and the feedback loops with ‘design development and oversight’, the three steps each embody their own intense and distinctive processes of communication. One further point that it is important to note at the outset, is that this framework distinguishes between the precautionary principle, precautionary appraisal and prevention. The precautionary principle is a general principle employed in the general design of risk governance as a whole, and in particular in the ‘screening’ of ‘threats’ for the properties of seriousness or uncertainty in order to determine their subsequent treatment in appraisal. Precautionary appraisal is a specific approach to appraisal adopted in cases where screening has identified a lack of scientific certainty. Prevention refers to the approach that is taken when a threat is identified as being both serious and certain. The Role of Screening In the screening stage, key features of the threat in question are identified in advance. These attributes are then used to select the best approach to more

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detailed appraisal, bearing in mind the particular kinds of information required for effective and efficient regulation. Screening also helps in prioritizing attention to different threats. This essential activity relates to established notions of ‘preliminary risk assessment’ in discussions under the auspices of the WTO and elsewhere, which can be either quantitative or qualitative in form (Vogel, 2004; Fisher, 2003). As discussed earlier, the term ‘threat’ is important here, because it admits interpretation either in terms of probabilistic risk or intrinsic hazard properties, depending on the context. Such intrinsic properties bearing on the ‘seriousness’ of the threat may relate to endpoint effects (such as carcinogenicity, mutagenicity or reprotoxicity) or – in the case of environmental pollutants – to exposure potentials like bioaccumulation, persistence and ubiquity (Mueller-Herold et al., 2003). Each of these offers a criterion of ‘seriousness’. Where any threat is held under these criteria definitely to be serious, then subsequent appraisal involves a ‘presumption of prevention’. There are a number of reasons why a threat may be considered not to be definitely serious. One important reason is where the threat is subject to scientific uncertainty, or ‘ignorance’in the senses discussed earlier. Screening here focuses on examining the applicability of probabilistic risk assessment techniques in any given case. Specific criteria include various questions about the status of the relevant theoretical frameworks, the presence of substantive novelty or unprecedented characteristics in the products or production processes and the sufficiency and applicability of the relevant models and data sources. Where any of these criteria are triggered then risk assessment techniques are ruled out and regulation instead takes the form of ‘precautionary appraisal’. Where a threat is judged neither definitely to be ‘serious’ nor ‘scientifically uncertain’, then the question remains as to whether it is nonetheless significant in scale or whether there exist complexities, which, whilst not scientifically uncertain, do warrant treatment using extended risk assessment techniques (Klinke and Renn, 2001). Criteria of ‘complexity and scale’ that may be employed to screen for such cases include the presence of cumulative or additive causal mechanisms and whether the threats involve exposed populations, potential scales of damage or likely time delays which exceed certain critical thresholds. Where any one of these criteria is activated, then the threat in question is assigned to ‘extended risk assessment’ in subsequent appraisal. Where threats are identified not to be definitely serious, and not to present scientific uncertainty or issues of scale and complexity, then there still remain questions over the ‘socio-political ambiguity’ of the threat (Collingridge, 1982; Thompson and Warburton, 1985; Renn, 1999; Stirling, 2003a). For example, is it associated with significant institutional conflict


295

or political mobilization or are there issues of ‘distributional equity’ or signs of ‘social amplification’ in the news media? If such criteria are activated, then the threat in question is assigned to a discursive process in subsequent appraisal. Where a threat is found not to be serious, uncertain, complex, large in scale or socio-politically ambiguous in any of the senses described above, then it may be subject to a ‘standard risk assessment’ process. As is conventionally the case at present, this is the approach that is adopted in the case of a very large number of instances of ‘routine risks’. The selection and constituting of the specific criteria with which to render operational these key features of screening, will itself involve an in-depth analytic-deliberative process of the kind discussed by the US National Research Council (Stern and Fineberg, 1996) and other bodies (Royal Commission on Environmental Pollution, 1998; House of Lords, 2000; German Advisory Council on Global Change, 2000). This ‘design discourse’ (Renn et al., 1995) will combine ‘scientific’, ‘political’ and ‘societal’ deliberation subject to all the principles of good governance discussed in Section 2. Examples of screening criteria can be found in Box 14.1.

BOX 14.1

EXAMPLES OF ‘SCREENING CRITERIA’ THAT MIGHT BE APPLIED IN FOOD REGULATION

These examples are not intrinsic to the framework, but depend on the outcome of deliberation over the appropriate choice of screening criteria in different cases. Examples of threats that might be construed as ‘definitely serious’ might include new and existing pesticide active ingredients for which there exists unequivocal qualitative evidence of properties such as genotoxicity and/or carcinogenicity and (possibly) reprotoxicity or endocrine disruption. Examples of threats that could be construed as ‘scientifically uncertain’ might include new genetically modified crop varieties, on the grounds that probabilistic risk assessment techniques are not fully applicable to modelling the ecological effects of proposed releases. Another example might be packaging materials including chemicals that are suspected of having endocrine disruption properties. Other examples might include uncertainty over the possible presence of a novel pathogen. Examples of threats that could be construed as‘complex or largescale’ would include well-understood food pathogens such as lysteria and salmonella and chemical agents routinely employed in

296


the food industry, as well as genetically modified organisms intended for contained use as an intermediate in a food production process. Examples of threats that might be construed as ‘ambiguous’ include a number of strategic technology-wide decisions, for example over the commercialization of modern agricultural biotechnology or the wider implementation of intensive industrial agriculture.

5. FROM SCREENING TO APPRAISAL: A PORTFOLIO OF APPROACHES As described above, the screening process may allocate threats to treatment by one or more of five different approaches to appraisal. Each is designed to gather the information necessary for regulatory decision making in different contexts in a fashion that respects governance principles of openness, accountability, effectiveness and coherence as well as precaution. Accordingly, each approach involves different rationales for – and thus forms of – participation. Of course, where a given threat displays a number of different attributes, these may be allocated to parallel treatment by the different forms of appraisal. If the threats in question are definitely serious then – as at present – subsequent appraisal adopts a presumption of prevention (Box 14.2). This is shown in dark shading towards the top of Figure 14.1. Rather than aiming

BOX 14.2

AN EXAMPLE OF THE ‘PRESUMPTION OF PREVENTION’ IN FOOD REGULATION

Prevention might be applied in the case of a genotoxic pesticide used to control fungal infection in an important food crop. In such a case, countervailing risks might be identified if, for example, there were human health risks arising from aflatoxin contamination due to uncontrolled fungal crop infection and the pesticide was the only available means of controlling this infection. In such a case, these mitigating factors would trigger further analysis of the genotoxic pesticide under a precautionary form of appraisal.


297

at further elaborate characterization of the threat, this involves simply examining for countervailing justifications or overriding social need, which would dictate a precautionary approach to appraisal. Otherwise, regulation results in the implementation of preventive measures. The main purpose in respecting the governance principle of participation, thus lies in the initial formulation of the appropriate screening criteria for the property of ‘seriousness’. On the other hand, if the threats in question are found under the screening criteria to be certainly and unambiguously not serious, not complex and not large in scale, then they are assigned directly to routine administration by standard risk assessment. Here, appraisal takes a straightforward form, based on probabilities and magnitudes, and can be performed by in-house staff using conventional techniques. It involves a presumption, subject to management considerations, in favour of approval. In terms of cooperative strategies, a discourse among agency staff and directly affected groups (such as product or activity providers and immediately exposed individuals) as well as enforcement personnel is advisable (instrumental discourse). One should be aware, however, that often risks that appear simple turn out to be more complex, uncertain or ambiguous than originally appraised. It is therefore essential to revisit these risks regularly and monitor the outcomes carefully. If screening is unable to allocate to straightforward preventive or standard management measures, then more elaborate appraisal procedures are undertaken. If a lack of scientific certainty has been identified in screening, then the subsequent regulatory process takes the form of precautionary appraisal. This involves a broad-based approach, with the full engagement of different interested and affected parties and does not rely on probabilistic techniques alone. Here, a number of ‘decision rules’ may help to guide the appraisal – including reference to established regulatory concepts such as ‘the polluter pays’, with protection thresholds set ‘as low as reasonably achievable’ and an emphasis on ‘substitution’ by the ‘best available technology’ (Raffensperger and Tickner, 1999). However, it is a distinct feature of this particular approach to appraisal, that precaution is addressed more as a ‘deliberative process’, than as a formulaic ‘decision rule’ (Stirling, 2003a; van Zwanenberg and Stirling, 2004). A key characteristic of this precautionary deliberation includes particular attention to the characterizing of uncertainties. However, it is also distinguished by the detailed consideration of benefits and justifications (as well as direct and indirect effects) of a full range of technology and policy options, looking at the entire associated product and life cycles. In establishing the evidence base, levels of proof are deployed such as to favour public health and the burden of persuasion is placed on proponents of the

298


products in question (Harremoës et al., 2001). In order to address intractable uncertainty and ignorance, explicit attention is given to properties of flexibility, adaptability, reversibility and diversity in different industrial and regulatory strategies (Stirling, 1999a, 2003a). In essence, the type of participatory deliberation required in this process of precautionary appraisal is a ‘reflective discourse’ (Klinke and Renn, 2002; Renn, 2004). It involves collective reflection over the balancing of possibilities of over- and under-protection under conditions of uncertainty and ignorance. If too much emphasis is placed on protection, certain innovations may be unduly prevented or stalled; if too little protection is afforded, society may experience catastrophic surprises. The classic question of how safe is safe enough is replaced by the question of how much uncertainty and ignorance the main social actors are willing to accept in exchange for some given benefit. It is recommended that policy makers, representatives of major stakeholder groups and scientists take part in this type of discourse. The reflective discourse can take different forms: round tables, open space forums, negotiated rulemaking exercises or mixed advisory committees including scientists and stakeholders. Examples of precautionary appraisal can be found in Box 14.3. Where a threat is directed in screening to treatment by ‘extended risk assessment’ it is, by definition, susceptible to characterization by probabilistic techniques. In such cases, appraisal uses conventional methods applied in a transparent fashion by interdisciplinary groups of external independent specialists. The knowledge inputs should be provided by an epistemological discourse aimed at finding the best estimates for characterizing and evaluating the risks under consideration (Klinke and Renn, 2002; Renn, 2004). This discourse should be conditioned by different scientific perspectives and the participation of dissenting experts. These participants may come from academia, government, industry or civil society. But their legitimacy to participate rests on their claim to bring new or additional knowledge to the negotiating table. The goal is to resolve cognitive conflicts. Exercises such as Delphi, Group Delphi and consensus workshops offer good means to fulfil the goals of this kind of epistemological discourse. On the other hand, where screening has identified ‘socio-political ambiguity’, then the choice of appropriate management instruments will be a discursive process, subject to inclusive participatory procedures designed to clarify and so help resolve this ambiguity. Examples can be found in Box 14.4. High ambiguities require the most inclusive strategy for participation since not only the directly, but also the indirectly affected groups have something to contribute to this debate. Informed by results of discursive processes in appraisal, which ‘open up’ the salient features of the


BOX 14.3

299

EXAMPLES OF ‘PRECAUTIONARY APPRAISAL’ IN FOOD REGULATION

A specifically precautionary approach to appraisal might be adopted, for example, on health effects from acrylamide contamination in high temperature food processing, or with the commercial release of a genetically modified crop. In the latter case, the kinds of substantive and procedural considerations that might arise take a variety of forms. First, the specification of ecological experimental and data requirements will require broad disciplinary and stakeholder involvement. Second, the scope of ecological assessment will include analysis of effects on a wide variety of species, over several generations. Third, this will include analysis of the anticipated size and distribution of social benefits of licensing the crop variety, alongside investigation into the nature and distribution of the risks. This will include analysis of the pros and cons of alternative technological means of producing the same crop product, including conventional varieties, under a range of management systems. Fourth, it will specify research programmes and evidence required to permit commercial release. Finally, it will involve analysis of means for reversing the licensing decision at a later date; for example, by considering technological options to ensure that the variety is infertile.

ambiguities in question and the particular divergences of perspective, the aim of this kind of participatory deliberation in the management of ambiguity is to ‘close down’ on the most robust basis for consensus or common ground in decision making. The type of discourse required here is called participatory discourse, illustrated by a series of approaches including citizen panels (Renn et al., 1995), consensus conferences (Joss and Durant, 1995) and deliberative mapping (Davies et al., 2003). Whatever form it takes, these kinds of participatory discourse are all subject to demanding governance criteria of openness and accessibility, clarity and accountability as well as timeliness and proportionality.The specific design of this participatory process should respect general criteria of good participatory process such as representativeness, transparency, accessibility and unconstrained scope (Renn et al., 1995; Rowe and Frewer, 2000; Petts, 2001; Clark et al., 2001).

300


BOX 14.4

AN EXAMPLE OF A ‘DISCURSIVE PROCESS’ IN FOOD REGULATION

This concerns the introduction of food irradiation as a means to reduce bacterial contamination of fresh foodstuffs. The technology would not be classified as posing a ‘definitely serious’ threat. Nor would there be any uncertainties pertaining to that classification because there would be no scientific doubt, in this case, about our theoretical understanding of irradiation as a technology, and it is not an entirely new technique. Similarly, we would be unlikely to have any serious doubt about the evidence and analytical techniques used to establish the effects of irradiation on fresh foodstuffs. As far as issues of complexity and scale are concerned, it is conceivable, for example, that irradiation might alter the nutritional constituents of a food and do so for very large populations. It is possible therefore that food irradiation would be subject to an extended risk assessment in subsequent appraisal. There are also, however, a number of public concerns about food irradiation which thus far have derailed any attempt to introduce the technology on a widespread commercial scale. Those concerns pertain, for example, to the possibility that food irradiation might be used to disguise a failure to ensure production and distribution of fresh food. In this case, the technology might therefore trigger the screening criteria on socio-political ambiguity. This would then be a matter for a discursive process in tandem with an extended risk assessment.

As shown by small two-headed arrows in Figure 14.2, the different approaches to appraisal are not necessarily mutually exclusive. If characteristics of uncertainty, complexity, scale or ambiguity are encountered at a later stage in appraisal, then different aspects of a threat may be assigned in series or parallel through the appropriate appraisal approaches.

6.

ALTERNATIVE DISCOURSES IN MANAGEMENT

As in conventional understandings of the regulatory process, the third major element in any general framework for precautionary governance, after screening and appraisal, is management. This involves the evaluation of the information yielded by the different appraisal processes and the


301

consideration of this information alongside other relevant social and economic factors. As in conventional risk analysis, the purpose of the evaluation process is to take account of the results obtained in appraisal, weigh this up against appropriate levels of protection, wider social and economic issues and the pros and cons of different possible instruments. Based on the general framework presented here, five types of decision-making strategies can be distinguished: routine, risk-informed, precaution-based, discoursebased and preventive strategies. Table 14.1 provides a summary of these five risk strategies and lists the kinds of instruments and tools that may be appropriate for the respective strategy. Table 14.1 Risk characteristics and their implications for risk management Knowledge Characterization

Management Style

Appropriate Instruments

Simple risk problems

Routine-based (risk evaluation) (risk reduction)

● ● ● ● ● ●

●

Risk problems due to high scientific complexity

Risk-induced (risk agent and causal chain)

●

●

Risk problems due to high unresolved uncertainty

risk-benefit analysis risk-risk trade-offs technical standards trial and error economic incentives education, labelling and information voluntary agreements Expert consensus-seeking tools, such as Delphi or consensus conferencing, meta-analysis, scenario construction. Results fed into routine operation

Robustness-focused (risk-absorbing system)

Improving buffer capacity of risk target through: ● additional safety factors ● redundancy and diversity in designing safety devices ● improving coping capacity ● establishing high reliability organizations

Precaution-based (risk agent)

Using hazard characteristics such as persistence, ubiquity as proxies for risk estimates.

302


Table 14.1 (continued) Knowledge Characterization

Management Style

Resilience-focused (risk-absorbing system)

Appropriate Instruments Tools include: containment, ALARA (as low as reasonably achievable), BACT (best available control technology) Improving capability to cope with surprises: ● diversity of means to accomplish desired benefits ● avoiding high vulnerability ● allowing for flexible responses ● preparedness for adaptation

Risk problems due to interpretative or normative ambiguities

Discourse-based

Application of conflict resolution methods for reaching consensus or tolerance for risk evaluation results and management option selection. Integration of stakeholder involvement in reaching closure. Emphasis on communication and social discourse

Serious risk problems

Prevention

Phase-out of activity Substitution Tolerance only when benefit is overwhelming

The Routine Risk Strategy This requires little change from traditional decision making. Policy goals are determined by law or statutory requirements and the role of risk management is to ensure that all risk reduction measures are implemented and enforced. Traditional risk-risk comparisons (or risk-risk trade-offs), riskbenefit analysis and cost-effectiveness studies are typical instruments of choice for finding the most appropriate risk reduction measures. It is important to note, however, that simple risks are not necessarily small or


303

negligible risks. The important point here is that the potential negative consequences are obvious, the values that are applied are non-controversial and the uncertainties low. The Risk-Informed Strategy This applies to threats that are complex in nature and where there is a need, in the preceding appraisal stage, for external expertise and experience so as to characterize reliably, for example, dose-effect relationships or the alleged effectiveness of measures to decrease vulnerabilities. Once the probabilities and their corresponding damage potentials are determined in appraisal, however, management can proceed in a similar fashion to that in the routine case. Traditional tools such as risk-risk comparison, cost-effectiveness and cost-benefit analysis are well suited to facilitate the overall judgement of risk evaluation. Properly used, these instruments can provide effective, efficient and distributionally fair solutions with respect to finding the best trade-off between opportunities and risks. The proper use of these instruments requires transparency over subjective ‘framing assumptions’, sensitivities and limits to applicability and their implications for the shaping of parameters on both sides of the cost-benefit equation. The Precaution-Based Strategy This applies to situations in which there exists uncertainty. Informed by processes of precautionary appraisal, detailed earlier, specifically precautionary management strategies may include, for example, an emphasis on the substitution of those options presenting the greatest threats, based on principles of ‘clean technology’ and ‘green production’, addressing entire product life cycles using ‘best available technology’ (BAT) and applying a strict ‘ALARA’ (‘as low as reasonably achievable’) criterion of admissible harm. Precautionary management may also be associated with more stringent provision for compensation, including strict and absolute liability regimes, mandatory insurance requirements and product-take-back schemes. It may also be associated with enhancing the resilience of riskbearing systems so that they can cope with surprises. Instruments for resilience include diversification of the means for approaching identical or similar ends and reducing overall catastrophic potential or vulnerability. It is important to recognise that these management strategies do not fully resolve the challenge of precaution and – indeed – raise their own further problems. A preoccupation with the uncertainties does not provide the management process with priorities for risk reduction. How can one judge

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the severity of a situation when the potential damage and its probability are unknown or highly uncertain? It is because of this dilemma, that risk management must be conducted in a fashion that is particularly subject to the governance principle of participation – engaging all interested and affected parties not only in the appraisal process, but also in the resulting management decisions. Such decisions may involve, for instance, questions over the appropriate trade-off between different safety margins and unlikely but potentially catastrophic consequences. The Discourse-Based Strategy This applies to situations in which information about a threat is interpreted in varying ways by different stakeholders and/or if assumptions about what should be protected are subject to dispute. Risk management, in such circumstances, needs to address the causes of such conflicting views. Very often such conflicts are not fuelled by differences over factual explanations or predictions but, instead, are based on different viewpoints about the relevance, meaning and implications of these findings for risk evaluation and risk management actions. Where we are confronted with such ambiguities, however, it is not enough to demonstrate that management is open to public concerns. As in the case with precaution, the governance principle of participation here requires transdisciplinary deliberation in the process of decision making itself – involving specialists from ethics, humanities and social (as well as natural) sciences alongside active engagement by wider interested and affected parties. Informed by results of discursive processes in appraisal, which ‘open up’ the salient features of the ambiguities in question and the particular divergences of perspective, the aim of this kind of deliberation in the management of ambiguity is to ‘close down’ on the most robust basis for consensus or common ground in decision making. The Prevention Strategy This applies in the case of a presumption of prevention. It does not, however, introduce any new elements beyond those already discussed in the context of appraisal. Existing preventive approaches yield a wide variety of instruments and measures appropriate for the reduction, phasing-out or banning of the activities or products in question. The only objective here is to eliminate the threat-causing activity in a fashion that is as economically efficient and socially acceptable as possible. The prevention strategy may, however, involve acknowledging that a threat may nonetheless be tolerated if the benefits or justifications are sufficiently overwhelming, Whilst


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depending intrinsically on the case in question, the criterion of sufficiency must, however, itself be extremely rigorous. Subject again to the governance principle of participation, such a criterion could only be determined and applied through a broad-based process of participatory deliberation of the kind applicable under ambiguity, and further legitimated through dedicated procedures of democratic accountability.

7.

STAKEHOLDER PARTICIPATION

Any decision-making process has two major aspects. The first concerns the issues and actors to include in the process of appraisal (inclusion). The second concerns the challenge of selecting among contending decision options (selection): questions over both ‘how?’ and ‘what?’ Inclusion and selection are therefore the two essential parts of any decision- or policymaking activity. Classic decision analysis offers formal methods for generating options and evaluating these options against a set of predefined criteria. With the advent of new participatory methods, the two issues of inclusion and selection have become more complex and sophisticated compared to the conventional strategies of decision analysis. Our understanding of risk governance rests on a distinction between four major actors, that is, the political, economic (business), scientific and civil society players that need to be involved in the process of problem framing, generating options, evaluating options and coming to a joint conclusion. Inclusive governance requires that: ● ● ● ●

●

●

there has been a serious attempt to involve representatives of all four actor groups (where appropriate); there has been a major effort to empower all actors to participate actively and constructively in the discourse; there has been a serious attempt to co-design the framing of the (risk) problem or the issue in a dialogue with these different groups; there has been a serious attempt to generate a common understanding of the magnitude of the risk (based on the expertise of all participants) as well as the potential risk management options, and to include a plurality of options that represent the different interests and values of all parties involved; there has been a major effort to conduct a forum for decision making that provides equal and fair opportunities for all parties to voice their opinion and to express their preferences; there has been a clear connection between the role of participatory bodies in decision making and the process of political implementation.

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If these conditions are met, evidence shows that actors, along with developing faith in their own competence, use the opportunity and start to place trust in each other and have greater confidence in the management process (Kasperson et al., 1999; Viklund, 2002). Inclusive governance needs to address the second part of the decision-making process as well, that is, reaching closure on a set of options that are selected for further consideration, while others are rejected. Closure does not imply the identification of a ‘final word’ on an initiative or regulation. Rather, it represents the product of a deliberation, that is, the agreement that the participants reached. The problem is that the more actors, viewpoints, interests and values are included and thus represented in an arena, the more difficult it is to reach either a consensus or some other kind of joint agreement. With respect to the closure of debates (be they final or temporary) a second set of criteria is needed to evaluate the process of closure as well as the quality of the decision or recommendation that is generated through the closure procedure. The first aspect, the quality of the closure process itself, can be subdivided into the following dimensions: ●

● ● ● ●

●

Have all arguments been properly treated? Have all truth claims been fairly and accurately tested against commonly agreed standards of validation? Has all relevant evidence, in accordance with the actual state of the art and prevailing knowledge, been collected and processed? Was systematic, experiential and practical knowledge and expertise adequately included and processed? Were all interests and values considered and was there a major effort to come up with fair and balanced solutions? Were all normative judgements made explicit and thoroughly explained? Were normative statements deduced from accepted ethical principles or legally prescribed norms? Were serious efforts undertaken to preserve plurality of lifestyles and individual freedom and to restrict the realm of collectively binding decisions to those areas in which binding rules and norms are essential and necessary to produce the desired outcome?

Turning to the issues of outcome, additional criteria need to be addressed. As introduced earlier, these involve issues of effectiveness, efficiency, accountability, legitimacy, fairness, acceptance, acceptability, proportionality and non-discrimination. The potential benefits that derive from stakeholder and public involvement depend, however, on the quality of the participation process. It is not sufficient to gather all interested parties around a table and rest all hopes in some kind of catharsis effect.


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In particular, it is essential to treat the investment of time and effort on the part of participating actors as scarce resources that need to be handled with care and respect. The participation process should be designed in such a way that the various actors are encouraged to contribute to the process on all issues where they feel they are competent and can offer something to improve the quality of the final result. Figure 14.3 provides an overview of the different requirements for participation and stakeholder involvement for the different management strategies. As with all classifications, the scheme shows an extremely simplified impression of the involvement process. Considering the crucial role of ‘design, development and oversight’ the framework sketched in Figure 14.2 and summarized in Figure 14.3 is not as closed or linear as might be suggested (for purposes of exposition) by the overview. Categorizing different threats according to the quality and nature of the available information will, of course, be contested among the stakeholders. Often a consensus may not be reached as to where to locate a specific case. In such cases, application of the precautionary principle at an ‘architectural level’ in this framework, would entail a detailed (worst-case) appraisal. Here, measures such as post-market monitoring and surveillance constitute important possible bases for compromise, by providing for timely detection, confident scoping and reversible reduction of threats. Such a situation may also require a design discourse in order to reach closure on the appropriate appraisal process.

8. CONCLUSIONS: CHALLENGES AND PRINCIPLES FOR THE FRAMEWORK AS A WHOLE It remains now only to reflect on the extent to which the framework summarized here does indeed address the various problems and principles set out at the beginning of the chapter. In this regard, it is useful to refer again to the threefold challenge set out in Section 3. This required, first and foremost, that any proposed new framework for the articulation of conventional and more precautionary approaches in an area like food safety should display enhanced compliance with the European Commission’s principles of ‘good governance’ that were introduced earlier. These comprised: accountability and participation; accessibility and openness; coherence and consistency; proportionality and non-discrimination; and effectiveness, timeliness and subsidiarity. Second, it was argued in particular that compliance with these governance criteria requires a high degree of specificity over the way in which an appropriate balance may be struck between

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Risk Trade-off Analysis and Deliberation Necessary Risk Balancing Necessary

Probabilistic Risk Modelling

Risk Balancing Necessary



Types of Conflict:

Types of Conflict:

Cognitive Evaluative Normative

Cognitive Evaluative

Type of Conflict:

Actors:

Cognitive

Actors: Agency Staff, External Experts, Stakeholders, such as Industry, Directly Affected Groups, Representatives of the Public(s)

Statistical Risk Analysis

Actors:

Actors: Agency Staff

Agency Staff, External Experts

Agency Staff, External Experts, Stakeholders, such as Industry, Directly Affected Groups

Discourse: Instrumental

Discourse: Epistemological

Discourse: Reflective

Discourse: Participatory

Simple

Complex

Uncertain

Ambiguous

Figure 14.3 The risk management escalator and stakeholder involvement (from simple via complex and uncertain to ambiguous phenomena) the roles played by different interests, constituencies, disciplines, methods, institutions and modes of engagement. Third, the initial conceptual discussion showed more specifically that the framework should (in addition to the conditions of ‘risk’ and ‘complexity’ addressed in established approaches to ‘risk analysis’), fully engage with the distinct, intractable and somewhat neglected problems of ‘uncertainty’, ‘ambiguity’ and ‘ignorance’.


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To start with the first of the European Commission criteria listed above, accountability is promoted by the fact that the overall structure of the framework fosters a relatively transparent, systematic and complete consideration of different kinds of ‘threat’ – extending well beyond the narrow confines of conventional risk assessment. Moreover, it does so in a way that permits greater clarity than is typical in risk analysis over the actual basis and location of policy decision making at particular points. More specific properties of coherence and consistency are also fostered by the explicit fashion in which different forms of incertitude are distinguished in screening, allowing them to be subject to more rigorously appropriate forms of appraisal than just risk assessment alone. In this way, for instance, complexity is addressed with extended risk assessment (as at present), but also ambiguity with discursive process and scientific uncertainty and ignorance (in the strict sense) with precautionary appraisal. Yet the introduction to this chapter also raised important concerns over the sufficiency of rigid decision rules as an exclusive basis for good governance. This applies as much to the specific criteria envisaged in the present framework, as to those employed in conventional risk analysis. It is for this reason that the present framework seeks also to strike a more measured and explicit balance between the respective roles played by transparent, consistent and coherent decision criteria and open, accountable and accessible, deliberative and participatory processes. In particular, preceding sections have discussed in some detail the different modes of participation and engagement at each stage in the process. This distinguishes the practical ways in which effective and proportionate provision might be made for different forms of ‘discourse’ in different specific contexts, such as to focus on, and help foster (as appropriate): education, cognition, reflection and design. This also helps address the particular need to be clear about the terms of engagement for different forms of knowledge, as well as different stakeholder interests and socio-political values. In short, the present framework seeks a finely judged middle way between a disproportionate, costly and time-consuming presumption of extreme precaution and comprehensive participation on every issue, and the imposition of expedient, rigid and unduly circumscribed barriers between the domains of ‘risk assessment’, ‘precaution’ and ‘participation’. Finally, the framework envisaged here also displays significant features in relation to principles of proportionality and non-discrimination. The proportionality of appraisal is promoted through emphasis on a screening process in which assessment techniques are tailored quite specifically to the type of ‘threat’ being assessed. The proportionality of management outcomes is addressed through ensuring that a wider variety of appraisal tools

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provide a more complete basis for management – allowing a full range of salient pros and cons to be weighed up in decision making. In this way, by subjecting the application of precaution to systematic principles and procedures and clarifying the relationship with risk assessment, the framework permits greater clarity over the basis for decision making, thus allowing correspondingly greater confidence over the non-discriminatory nature of policy with respect to different products, organizations or trading partners. It is in this way that concerns over timeliness and subsidiarity (not resolved here) may also be addressed. Although some of the procedures envisaged here are likely to be quite elaborate and time consuming, none are entirely new to the field of risk governance. Most are already practised on an ad hoc or expedience basis. What is new, is that the framework provides a coherent architecture for their more efficient articulation. In any event, the procedures envisaged here are only likely to be elaborate or protracted in cases where the adoption of more narrow or limited procedures of risk assessment would be likely to provoke even more corrosive and resource- and time-consuming political conflict. Whatever the truth of such arguments, these and other issues are all ultimately a matter for continual review and deliberation as part of the design and oversight function in the framework itself. They are also the focus of current ongoing research activity as part of an Integrated Project on ‘Safe Foods’, under the auspices of the European Commission’s Framework 6 Programme (Kuiper and Marvin, 2005). Notwithstanding the many remaining challenges, qualifications and queries, then, it may cautiously be concluded that a framework such as that described here, does warrant further critical scrutiny and constructive attention as a potential basis for addressing the many intractable challenges in the governance of risks such as those encountered in the field of food safety. It is in this way that we may hope to mitigate the present confusion and controversy over the relationship between ‘science’ and ‘precaution’ and understand the possibility for measured and effective practical implementation of the precautionary principle in the appraisal – as well as the management – of risk.

NOTE 1. This chapter summarizes results obtained as part of a wider collaboration between a number of colleagues. Particular debts are owed to Elizabeth Fisher, Andreas Klinke, Marion Dreyer and Christine Losert and more recently to invaluable comments from Ellen Vos.


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Index abstention 69 acceptability 94 of effects 212 accountability 125, 129, 131, 296, 309 in decisions 118 in governance 285 moral 145 political 145 action 129 costs of 26 on the principle 130 preventive 52 adjudication of disputes 162 on precaution 155 administration 124, 125, 129 functions 152 law 154, 155 Australian 148 review function 149 Administrative Appeals Tribunal 150, 151, 190 administrative constitutionalism 113–36 deliberative-constitutive theory 119–24 rational-instrumental theory 124–6 admissible evidence 150 adversarial context 144 adverse consequences, potential 162 adverse effects 37, 38, 270, 277 advice decision makers, to, framing of 198 misleading and inaccurate 197 Advisory Group on Greenhouse Gases proposals 255 aesthetic benefits 223 African Convention on the Conservation of Nature and Natural Resources (2004) 225 African-Eurasian Waterbird Agreement (1995) 226, 240 agency, data quality 144

agency, discretion in United States 44 Agreement on Sanitary and Phytosanitary Measures (SPSA), see Sanitary and Phytosanitary (SPS) Agreement Agreement on Technical Barriers to Trade (TBTA), see Technical Barriers to Trade Agreement (TBTA) agricultural biotechnology 22 agricultural practices 32, 33 agricultural products in Japan 181 agricultural subsidy 231 agricultural trade implications 208 agriculture 2 conversion to 224, 236 damage to 250 AIDS 72 AJKA Pty Ltd v. Australian Fisheries Management Authority 191, 193, 200 albatrosses 226 Aldekirk P/L v. City of Port Adelaide Enfield and Environment Protection Authority 158, 192 alien species 224–5, 228, 232, 235, 239 Allocation and Management of Water 240 Almaden Research Center 281 Alpharma v. Council [2002] 11, 16, 27, 39 alpine ecosystems 256 alternative solutions 44, 46, 92, 94 Alumino (Aust) Pty Ltd v. Minister Administering the Environmental Planning and Assessment Act 1979 (1996) 158 ambiguities 287, 289, 291, 298, 299 amphibians 223 analysis 206 rigorous 130 risk, defensible 52

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Index animal foodstuffs 4 animal safety, biases to human health over 169 studies on 48 welfare 231 animals health 24, 163, 165 protection 164 Antarctica ice sheet 251 antibiotics in feedstuff 27, 29, 30 apocalyptic outcomes 66, 76 Appellate Body of World Trade Organization 162–3, 166 Appellate Body Report, European Communities – Meat (Hormones) 1998 16 Appellate Body Report, Japan – Measures Affecting the Importation of Apples (2003) 16 AP Pollution Control Board v. Nayudu 1999, India 11, 16 apple importing, Japan 170, 171, 172, 181 appraisal 296–300 knowledge necessary 290 precautionary 298 technology options 287 aquaculture 224 aquarium fish 174 Argentina 226 Artegodan GmbH v. Commission [2002] 11 asbestos 72 ban, France 67, 168 carcinogen 173 control, Canada 168 European Communities 181 regulation 56 toxicity 57 Asbestos dispute, Canada and France 168, 173 asbestos industry challenge 56 Associated Provincial Pictures Houses Ltd v. Wednesbury Corporation 200 Association Greenpeace France v. Ministère de l’Agriculture et de la Pêche, Case C6/99 [2000] 26, 41 Atlantic sea 226 Australia 88–109, 137–59

317

case law and the threshold test 9, 190–93 courts and tribunals 182–201 environmental policy 204, 210 law commentators 141 legislation and precaution 184–6 legislative regimes 147 Australia-Salmon AB 181 Australian administrative context 137–59 Australian Fisheries Management Authority 185, 192, 195 Australian GMO regulatory framework 208–15 Australian Pork Limited v. Director of Plant and Animal Quarantine (2005) 158 authority weakening 53 automotive industry 273 ‘average’, study of 52 awareness, lack of shared 231 bacterial contamination of fresh foods 300 bait fish imports 174 balance of probabilities 141, 189 Bannister Quest v. Australian Fisheries Management Authority (1997) 200 bans on products 27 Bayesian methods 142 beef and growth-promoting hormones 170, 240 ban 125, 170 exporters, compensation 175 exports from UK 39, 82 hormone-treated 175 bioaccumulation of pollutants 294 biodiversity 88, 239 conservation 7, 223–44 food and fuel and 223 increase, in forests 263 level of protection of 230 loss of 33, 223, 254 medicines and 223 poverty and 233 resource conservation of 229, 233 urgency of 239 value of 230–31

318

Index

biodiversity-related law and policy 225–39 biological consequences 169 biosafety 225, 228, 232; see also Cartagena Protocol on Biosafety biotechnology 4, 30, 274 bird species 223 black market creation 236 Boughey v. The Queen (1986) 153, 154, 158 breast cancer risks 42 breast milk and polybrominated diphenyl ethers 49 Briginshaw v. Briginshaw 152, 158 building materials 223 bulk consumers 102 bureaucracy 123, 144 business risks 79, 153 bycatch reduction, fish 191, 195 Cabinet submissions 93 Cameroon 226 Canada 3, 185 cancer and hormones 170 canola, GM 218, 219 carbon dioxide emissions 89 carbon nano particles 273 carcinogenicity 48, 294 of asbestos 173 carcinogens regulation 54, 236 car spray painting workshop in suburb 192 Cartagena Protocol on Biosafety (2000) 4, 82, 228 case law 4, 9, 149, 150, 187 autonomy of 79 cases, list of 158–9 catastrophism 63–84 cattle, growth hormones 124 causality 47 causes, indirect 89, 90 caution 43, 50, 89, 151, 185 Center for Responsible Nanotechnology, US 274, 275 Centre National de la Recherche Scientifique 84 certainty, lack of, of scientific knowledge 84; see also scientific uncertainty; uncertainty cetaceans of the Black Sea 226

challenges 187 decision 193 politicians 53 to restrictions 56 changes in climate, unprecedented 247 Charter of the Environment project, France 73–5 chemical releasing 89 chemical risk assessment 146 chemicals adverse effects 276 industrial 230 restriction of 56 risk assessment 38, 39 safer 58 toxic 47 uncertainty about 55 chemistry, green 58 children environmental health studies 52 health impacts on 53 risk to 48–9 CITES, see Convention on International Tradein Endangered Species citizen participation 289 citizen, public autonomy of 10 civil law 139, 155, 189 civil litigation 151 civil standard of proof 152 clarification 103–6 climate 103 regulation 223 targets 256 climate change 7, 9, 22, 24, 29, 34, 90 accelerated 261 anthropogenic 246–9 extreme 262 management 27 precaution and 245–69 climatic impacts 250 CO2 concentration 246 coastal biodiversity 225, 255, 256 coastal wetlands 259 code of practice 178 Codex Alimentarius Commission (Codex) 177–8 codling moth, Japan 170 cognition 309 cognitive sciences 274

Index coherence 296 collective decision making 286 commercial aspects 56 Commercial Crash Repairs P/L v. Corporation of the City of Adelaide 192 commercial fishing 190 licences 183 commercialization of gene technology 208, 211 of wild resources 224 Commission on Sustainable Development 177 commissions of enquiry 105 committal proceedings 141 common framework 104 common law 141, 145 communication 261, 265 Communication on the Precautionary Principle (EC 2000) 114, 124, 125 community 89, 90, 99, 120, 210, 211 community judgements 213 Community Law 267 community values 207 community well-being 88 compensation conservation and 235 legal liabilities 103 complexity 291 complexity theory 262 concern, reasonable ground for 31 conflict 232 of views 304 consent refusal 191–2 consequences 142, 207 prediction 160 reversibility 162 conservation management of wildlife and 237 objectives of 164 of exhaustible natural resources 165 priority areas 233 Conservation Council of SA Inc v. Development Assessment Commission & Tuna Boat Owners Association (1999) 150–51 consistency in decisions 118 constitutional norm in France 73–9, 85 constitutional reform in France 63–87

319

constitutional status of precautionary principle 78–9 Consumer Product Safety Commission, US 48 consumers concerns of GMOs 215, 216 health 178 protection of 24 consumption forms of 95 production and 89 contaminant 169 context-specific guidance 154 contribution to repair of damage 74 controversies 124 Convention on Biological Diversity 3, 239 Convention on Climate Change 3 Convention on International Trade in Endangered Species of Wild Flora and Fauna (CITES) (1975) 225, 226, 227 cooling of Northern Europe 249 coordination, lack of 233 coral reefs 255, 259 fish harvesting 236 mortality 254 Corporation of the City of Enfield v. Development Assessment Commission and Another (2000) 158 Corrosion Proof Fittings v. EPA (1991) 56 corruption in government 233 cosmetic solvents 48 cosmetics 2 Costa Rica 226 cost-benefit administrative state 131 cost-benefit analyses 20, 27, 37, 38, 99, 105, 162, 208 cost-effectiveness 218 costs and benefits 26 to vulnerable groups 239 Council of Australian Governments (COAG) 101, 103 court decisions, compliance with 56 Court of Appeal of South Australia 151 court proceedings 105

320

Index

courtroom terminology 138 courts and tribunals 7 courts, matters for 187 cremation of human remains 192–3 Criminal Code (Tas) 153 criminal law 79, 139, 145, 154 principles 155 criminal proceedings 140 Crown Prosecutor 140, 141 cumulative effects 90, 212 current practice and alternatives 39 damage 70, 78 environmental 138, 139 potential 69, 70 serious or irreversible 74–5, 84, 152, 182, 192 dangerousness 143 data 205 de minimis test 154 death 153, 154 causing by recklessness 154 rate of sea lions 197 risk 143 De Brett Investments Pty Ltd and Anor and Australian Fisheries Management Authority, Re (2004) 158 deception 173 decision making 5–8, 11, 114, 116, 126–8, 140, 146–8, 202 discretionary 186 law and 156 processes 9, 123, 205, 210 science, avoidances 53 decisions analysis 305 challenging 195, 196, 198 flawed 115 justifying 129 preventative 189 supporting the principle 196 deep-sea trawling 227 deep water formation 250 defence 95 deforestation, tropical 224 degradation 45, 236 of biodiversity systems 223 environmental 89 deliberation 10, 19, 20, 22, 127, 129

deliberative practices 10 democracy 116 democratization of risk assessment processes 217 deoxyribonucleic acid, see DNA design 309 developed and developing countries 177, 237 development assistance in 95, 233 consent and refusal for 189, 191, 192 development projects 93 opponents of 92 proponents of 92 diet and obesity 51 direct threats 94 disasters, potential 261 disciplines of World Trade Organization agreements 163 discourse-based strategy 304 discretion 187 discretionary power 124, 194, 204, 210 ‘discursive process’ in food regulation 300 disease 45, 169 distribution 249 etiology of 58 infection and 153 outbreaks 253 risks 171, 205 Dispute Panels 164 dispute settlement framework 160, 161, 163, 173, 175 dissemination of GMOs, limiting 212 DNA research 279, 280 Doha Round 177 dolphins 227 population deaths 196, 227 domestic measures 164 domestic regulation 165, 167, 176, 177 domestic standards, harmonization of 168 drought 249 drugs 2 duty to act with precaution 183 to conserve and improve the environment 74 to prevent damage 74 on public agencies 185

Index earliness of risk consideration 69 earliness principle 85 early warnings capacity to act 264 of risk 46 Earth changes 246–7 temperature increase 247 Earth Summit, Rio de Janeiro 82 East Antarctica Ice Sheet 253 EC-Hormones AB 166, 167, 175 EC-Sardines AB 167 Ecole Polytechnique 84 ecological processes 205 ecological sustainable development (ESD) 88, 101, 151, 163–4, 210; see also sustainable development ecological systems 45 ecology 30, 59, 95 economic activity expansions of 175 international 160 restriction of 11 economic competitiveness 73 economic concerns and human health 26 economic consequences 169, 213 of GMOs 215 economic development 160 economic efficiency 101, 104 economic impacts of regulation 57 economic objectives 195 economic sustainability 233 economic welfare 73 economy, strong 89 ecosystems 34, 90, 203 complexity of 204 damage 43, 170, 250 degradation 223 diversity 223 for survival 213, 215, 263 threats to 223 see also biodiversity ecotourism 237 education 95, 309 on the environment 75 effectiveness 285, 296 effects and negative effects 29, 278 electricity sector 102 embargo on UK beef exports 82

321

emissions levels 192 acceptable 47 reduction, maximum rate 259–60 endocrine disruption 42 in wildlife 50–51 energy efficiency 260 use, increased 102 enforcement, poor, of regulations 233 engineering 205 environment 2, 205 adverse effects 23, 32 balanced 74 charter, France 74–5 definition of 214 GMO spread in 212 health and 11 priority to 37, 38 protection 24 significant risks and damage to 81, 212 trading off 101 Environment Protection and Biodiversity Conservation Act 1999 93, 103, 200, 218 environmental administration 144 environmental agencies 57 environmental chemistry 59 environmental concerns 93 environmental damage 89, 139, 140, 143–6, 184, irreversible 119, 137 environmental decision making 202 environmental degradation 91, 99, 116, 137, 204 Environmental Education Trust of the New South Wales Government 119 environmental effects 94, 156, 176 environmental impact assessment (EIA) 89, 93, 105, 145–6, 153, 162, 216 global and domestic 177 of hazard 125 of trade liberalization 175 environmental law 141, 154 in Australia 138, 182 international 3, 4 environmental management 71

322

Index

environmental measures, inadequacy 163 environmental policies 25, 42–62, 151, 187 Australia 145, 146 environmental problems 7, 9, 124, 127, 128 environmental protection 73, 131, 165, 173 Environmental Protection Agency (EPA) US 55 environmental regulation 137–59 environmental release of GMOs 216 environmental risk 104, 156, 166, 203, 204, 208 and technology 207 environmental science 42, 43, 45, 47, 50, 55 and policy 59 environmental sustainability 101, 233 epidemiological studies 46, 59, 278 epistemic debates 39 equality of participants 10 Equator 259 equity 233–5 error-minimizing 50 Espoo Convention 93 ethical matters, GMOs 170, 216 ethics 208, 215 Europe 9 and polybrominated diphenyl ethers (PBDEs) 49 Western and Northern climate 250 European Commission 4, 38, 71, 117–19, 175 bodies 285 Communication on the Precautionary Principle 114 ‘good governance’ 307 guidelines on the precautionary principle 25–6, 28, 30, 31, 35, 36, 37–8 nanotechnology and 275 proof and 70 European Court of Justice 23, 27, 28, 39, 133, 284 Court of First Instance of the European Communities 84

European Environment Agency 39 European Food Safety Authority (EFSA) 35, 72 European Union 3, 5, 63, 124 European Union Directive on the Conservation of Natural Habitats and of Wild Flora and Fauna (Habitats Directive) 225 European Union Environment Action Programme (2001) 256 European Union SEA directive 93 European Union Treaty 25, 26 European wildlife conservation 239 import restriction 227 international law 80–81 law 85 practice 19 evaluation of risk 205 evaluations, fixed standards 32 evaporation reduction 250 evidence 47, 140, 170 absence of 148, 149 conclusive 139 court 145 expert 144 for threshold test 192, 194–5 lack of 17, 53, 70 quantum or quality 155 risk 49 rules of 149, 150 scientific 156 uncertainty of 191 evidence-based approach 147 evidence law 154, 155 evidential burden 141 evidential concepts 138, 144–6 exclusion of public comments, GMOs 217 expert categorization systems 217 expert opinion 207, 211 expert testimony, scientific 144 expertise 127, 303 experts 206 influenced by commercial interests 72 exploitation of forests 231–2 export quotas 227 exposure 49, 278 to multiple chemicals 52

Index extinction irreversible 224 of species caused by human activities 223 threshold of dolphins 196 fact determination 152, 154, 155 fact-finding principles 147–55 facts of the case 188 failure to detect 50 fair trade 178 falsifiability 70 farm goods 153 farmers, Mexican 51 Federal Parliament, Australia 128, 203 fertility of soil 223 fiction and precaution in nanotechnology 270–80 field trial of GMOs 211 finance 95 financial interests, countering 44 fire-blight from apple imports, Japan 170, 172 fish catching levels 190, 191 landing of bycatch species 183 non-target species 195 stocks 190, 191, 239, 240 threatened species 183 fisheries 4, 9, 227–8 closure of 198 conservation 227 exploitation 227 legislation and policy 228 management 183, 191, 227 Fisheries Management Act 1991 (Australia) 185, 195, 199, 200 fishing industry appeal 196 fishing nets 197 fishing permit 190 fishing, moratoria on 235 flame retardants 49 flood control 223 food and food products, standards 2, 178, 213, 223 crises 72 industry, chemical agents 295–6 irradiation 300

323

law 31 production 290 regulation 295–6, 299, 300 safety 4, 165, 284, 285, 286, 307 governance 284–315 measures 163 regulation 7, 63, 177 sanitary requirements 163 security reduction 249 standards, national 178 storage 264 food additives 169 Food and Agriculture Organization of the United Nations (FAO) 177, 227 Code of Conduct for Responsible Fisheries 228 Food and Drug Administration (FDA), see United States Food and Drug Administration food-borne risks 169, 170 foreign ownership approval 95 Forest Principles for a Global Consensus 240 Forest Stewardship Council 239 forestry 102, 230, 231 forests boreal 256 clearing 230 fauna 230 law and policy 231–2 products 234 tropical 224, 231 fossil fuel consumption 252 framework, coherent for fact finding 156 frameworks 105, 117 for the precautionary principle 113–36, 285 France, constitutional reform 63–87 France-Nature-Environnement 74 fraud 173 freedom, individual 73 French Constitutional Court (2005) 85 French Constitution, precautionary principle 76, 80 frequentist methods 142 fresh and seawater 250 freshwater 224, 231 Friends of the Hinchinbrook Society

324

Index

Inc. v. Minister for the Environment (1997) 200 fruit varieties in Japan, treatment 170 fuel 223 funding 51, 55, 57–8 fungi 224 gas hydrates 249 GATS, see General Agreement on Trades in Services GATT, see General Agreement on Tariffs and Trade gene diversity 223 ‘gene flow’ 33 General Agreement on Tariffs and Trade (GATT) 160, 164, 165, 175 tariff elimination 163 General Agreement on Trades in Services (GATS) 164, 165, 176 generations, future 90 genes and cancer 51 gene technologies 208, 209 Gene Technology Act 2000 (GTA) Australia 203, 208, 213–17 Gene Technology Community Consultative Committee 218 Gene Technology Regulations (2001) 214 Gene Technology Technical Advisory Committee 211 genetic modification 212, 279 genetically modified organisms (GMOs) 22–30, 33, 42, 202_20, 228, 230, 296 agriculture’s impact on non-GM farming practices 214 canola 213 crops 295 European directive on 32 feedstuffs 36, 219 imports, right of refusal 82 licence applications 213, 214, 215 regulatory framework, Australia 204 genomes and pollutants 58 genotoxic pesticide 296 glacier melting 248 global circulation patterns 250 global climate change 82 global economic integration 160 global environment 46, 84, 89

Global Strategy for Plant Conservation 232 global warming 42, 247, 255 GM canola 218 GMO, see genetically modified organisms (GMOs) governance 286–9, 233 government action 23 government funding for scientific research 55, 57 government policy proposals 94 grape farm, Australian 153 gravity of consequences 142 greenhouse gases 102, 246–8 emissions 255 greenhouse warming effect 252, 253 Greenland Ice Sheet 231, 249, 251–3 Greenpeace 280 Association Greenpeace France v. Ministère de l’Agriculture et de la Pêche, Case C6/99 [2000] 26, 41 Greenpeace France 2005 66 UK and technologies 275 ground water extraction 251 growing season, length of 248 growth hormones in cattle 124, 170 in food 175 guidance 117 guilt, proving 139 Gulf Stream 245, 250 habitat degradation 237 destruction of marine species 227 loss 253 harm 35, 161–2, 303 acceptable or preventable 44 conclusive proof of 198 irreversible 169 levels 44–5 threat of 162, 202 to human health 205 harmful activities 235 harmonization 167 harvesting of resources 235 hazards 65, 66, 67, 68, 206 characteristics 178 eradication 74 identification 125

Index potential 43 research 45 see also risks hazardous activity 276 hazardous waste 236 health 57, 165 economic considerations and 20 effects, adverse 30–31, 52 environment and 11, 160 hazards 79 objectives 167 problems 127 safety and 146, 203, 208, 212 health protection levels 164, 166 health risks 178, 212 management 71, 178, 203, 204 technology 207 threats 169 healthcare from wild products 233–4 heat waves 248 Hector Dolphin, protection of 196 herbicide resistant genes 33 herbicides 215, 219 High Court of Australia 145, 153 high-impact events 261 hormones and cancer 170 hormone-treated livestock 230 household dust 48 human activities and climate change 247 human blood and body fluids 48, 49 human dependence on biodiversity 223–4 human development, unsustainable 89, 90 human environmental protection 164 Human Genome Project 272, 273 human health 24, 26, 32, 37, 38, 116, 173 over animal safety, biases 169 over plant safety, biases 169 risk to 39 human risk 166 human settlement 89 human social systems 45, 170, 230 human tissues 49 hydrological systems 102 hydrology 59 hypothesis-testing 50 hypothetical effect 29

325

ice ages 246 ice, melting rate increase 251 ice sheet dynamics 251, 252, 253 IGAE, see Intergovernmental Agreement on the Environment ignorance 9, 121, 224, 277, 291, 294 impact indirect 99 serious and irreversible 92 unacceptable 32 impact assessment 4 import restrictions to conserve biodiversity 227, 232 imported goods infection in 153 restricted 170 improper purpose 194 inaction, costs 162 incentive mechanisms 89 incertitude 287–9 incinerators, exposure 52 inclusion 305 income protection 231 Independent Expert Group on Mobile Phones 4 independent oversight 94 indeterminacy 121 India 3 indigenous knowledge 99, 170, 238 individuals, harm to 153 industrial interests 72 industry 5, 95, 211, 231 health and safety regulation 146 policy 93 infection 153 information 31, 150, 196, 197, 304 exchange 286 from science 71 needs 103 information technology 274 infrared radiation 247 innocence, presumption of 139, 150 innovation 76 culture of in US 44 responsible 272–80 inshore set netting closure 196 insurance 206, 264, 303 integrated assessment (IA) 93 intensive agriculture 231, 296

326

Index

interaction between human and natural systems 229 interdisciplinary approaches to research 45, 58 to science and policy 46, 51, 90 Intergovernmental Agreement on the Environment (IGAE) (1992) 3, 137, 184–5, 188–9, 191, 195 Intergovernmental Panel on Climate Change (IPCC) 247 International Commission for the Conservation of Tunas (ICCAT) 227 international cooperation 23, 81–4 International Covenant on Civil and Political Rights 139 International Forum on Forests 232 International Geosphere Biosphere Programme 246–7 international law on forestry 231 International Organization for Standardization (ISO) 177 International Panel on Forests 232 international standards 163, 165, 167, 177–9 international trade 164, 231, 232 International Tribunal for the Law of the Sea: Southern Bluefish Tuna Cases (New Zealand v. Japan; Australia v. Japan) (1999) 11, 16 International Tropical Timber Agreement 232 intervention 45, 262, 278–9 invertebrates 224 investment 96 InVigor canola application 218 irradiation of fresh foods 300 irreversibility 90, 119, 212 James Hardie & Coy Pty Ltd v. McGuiness (2000) 158 Japan – Measures Affecting the Importation of Apples 16 judicial review 14, 145, 148–52, 184–9, 194, 198 error of law 197 jurisprudence of World Trade Organization 138 Justice v. Australian Fisheries Management Authority 190, 199

justiciability of precaution 186–8 justification 183 Kakadu National Park, mining 99 Kenya wildlife decline 237 kidneys, phthalates, effect on human 48 knowledge assessment 35, 47, 288, 301, 302 major gaps 191, 224 partnerships 265 systems 99, 100 Korea – Measures Affecting Imports of Fresh, Chilled and Frozen Beef 181 Kyoto Protocol, watering down of 82, 246 Lamason v. Australian Fisheries Management Authority [2004] 218 land management 90 use 102, 246, 253, 264 law and policy 78, 80, 81, 116 law in US, on chemical restriction 56 law texts 84 lay people 206 lead toxicity 57 learning, productive 277–81 Leatch v. National Parks and Wildlife Service and Shoalhaven City Council (1993) 158, 200 legal burdens of proof 100 legal challenge 182, 194 legal content of principle 187, 188 legal culture 5, 130 legal defensibility 103 legal obligations 127 legal processes, fairness 145 legislation, Australian 182 legislative change on GMOs 217 legislative control 125 legislative mandates 182, 198 legislative rules 145 legitimacy 2 legitimate action 118 levels of safety 165 liberalization 160 libertarian movements 73 licence issuing 214 licence to research in nanotechnology 275

Index life-support systems 88 litigation 4, 11, 183 Little Ice Age 250 Living Marine Resources Management Act 1995 (Tas) 200 local government in Australia 128 logging 230 moratoria on 235 logical reasoning 125 long-term effects 212 of GMOs 30, 206 loss of habitat 224 Lowell Center for Sustainable Production, US 44 Lowell Statement on Science and the Precautionary Principle 45 lysteria 295 Maastricht Treaty 63 magnitude, predicted, of harms 205 mammals 223 management 238–9, 291–3 adaptive versus absolutist 239 discourses 300–305 of risk 205 mandatory consideration 210 mangrove ecosystems 259 Marine Aquarium Council 239 marine environment 224 biodiversity 185, 193, 225 pollution 3 species 174 incidental capture of 227 sustainability 195 Massachusetts Toxic Use Reduction Program 47–8 Maximin principle 85 McDonald v. Director-General of National Parks and Wildlife (1994) 158 meat, wild, poaching in Kenya 237 mediation 105 medical care 79 medical device industry 53 medicinal plants 236 medicines 223 Mediterranean Sea 226 merits review 148–52, 155, 184, 194, 198 Merrimack Valley of Massachusetts 52

327

methane 249 methodology 124 methylene chloride 54 microclimate regulation 231 migration 253 of human populations 249, 253 migratory species 225, 240 military defence 79 military robots 273 mining lobby 99 minority views 39, 171 mobile phone regulation 4 models of social-ecological systems 262 molecular manufacturing 274, 276–7 monitoring, role of long-term 262–3 Montreal Protocol on Substances that Delete the Ozone Layer (1994) 3 moral dimensions 90 moral imperative 66 moratoria on hunting 235 on nanotechnology 273 most-favoured-nation treatment 164 multi-criteria analysis 99, 105, 289 multidisciplinary teams 50 multilateral agreements 225, 232 multinational companies 280 multiple interactions of exposure 52 mutagenicity 294 nanotechnology 7, 9, 230, 270–83 narrow risk assessment mandate on GMOs 213, 214, 215 nation states 23–4 National Competition Council (NCC) 101 National Competition Policy (NCP) 101, 102 national interests, influence of 72 national law, policy and biodiversity 226 national sovereignty 81–4 national standard setting 165 National Strategy for Ecologically Sustainable Development 3 National Water Commission, Australia 103

328

Index

National Water Initiative (NWI), Australia 101 natural environment and agriculture 32, 33 natural resource management (NRM) 9, 195, 231, 236 natural resources 168, 173, 176, 225, 234 natural sciences 99, 100 negative consequences of prohibition 236 ‘negative effect’ 126 negative, proving 70 negotiation 105 Netherlands Commission on Genetic Modification (COGEM) 32 Netherlands dyke collapse 249 neurological development 51 New Zealand High Court 196 Nicholls v. Director-General of National Parks & Wildlife (1994) 158 non-cooperation 237 non-discrimination 163, 285 non-governmental associations 117, 175 non-medical implants 273 non-protectionism 163 non-tariff barriers to trade 163 North American Free Trade Agreement (NAFTA) 176 North Atlantic current 245, 250 North Atlantic Salmon Conservation Organisation (NASCO) 227 North Sea protection 29, 82 North Sea waste dumping 30 Northern Inshore Fisheries Company Limited v. Minister of Fisheries 196, 200 Northern spotted owl Strix occidentalis aurina 238 noxious substances 278 NRM, see natural resource management nuclear energy 260 nutrient cycling 223 nutritional content of food 300 oak forests 256 objectivity 115 of risk estimates 207 objector, obstacle for 139

Oceans Act 1996 200 ocean depths 224 ocean observation system 251 oil-seed rape, herbicide resistant 32 onus of proof, see proof, burden of openness 296 Organization for Economic Cooperation and Development (OECD) 176 outcome assessment of 131 dangerous 189, 204 over-exploitation of resources 224 from poor enforcement 230 from poverty 230 ozone depletion 22–3, 27, 29, 280 Pacific Century Production Pty Ltd v. Watson [2001] 153, 154, 155, 158 packaging materials 295 paleological insights 256 paleoscientific studies 262 pathogens 295 permafrost 249, 251 permits, refusal to grant 191 pesticide effects on children’s health in Mexico 51 ingredients 295, 296 pests and diseases 30, 169–71, 253 petrels 226 Pfizer Animal Health SA v. Council [2002] 84, 136 photosynthesis 223 phthalates and toys 48–9 impacts on children 53 planning matters 195 plants 24, 30, 153, 163–5, 224 safety, biases to human health over 169 plasticizers in toys 48 plastics and foams 49 poaching in Kenya 237 policy 2, 30 analysis 19 assessment 4, 7, 8, 92–9, 105, 199, 206 definition of the precautionary principle 37

Index formulation 47, 90–91, 97 institutional change and 104 management framework and 234 policies of government 55, 99 practice and 10 traditional science and 53–5 political cover-ups in science 53, 54 political dimensions 22–7 political will 104, 237 pollen 256 pollutants 175, 237, 294 effect on wildlife in Great Lakes 51 ‘polluter pays’ principle 73, 297 polybrominated diphenyl ethers (PBDE) 49 polyvinyl chloride 48, 53 population 246 environment and 90 high-risk 47 impacts on 46 viability analysis 105 possibilities 141, 143, 154, 288 potential for spread of GMO 212 poverty 233, 239 power plants 89 precaution 43–5 concerns 210 defensive tool 179 implementing 155 implementation of precaution 6, 202, 205 in Gene Technology Act 209–11 in governance 286 negativity of concept in US 44 obligation of precaution 161 ‘paralysis by precaution’ 238 regulatory consistency and 174 risk analysis and 178, 202–20 role of 42–62 science and policy 59, 140, 150, 286–9 strength of 121, 122 World Trade Organization and 160 see also precautionary principle precautionary administration 148–54, 262–3, 277 ‘precautionary appraisal’ in food regulation 299 precautionary assessment targets 102 precautionary autonomy 161, 164, 179 precautionary governance 290–91

329

precautionary legislation 137 precautionary obligations 176 precautionary policy 1–11, 88–109 precautionary principle 37, 73, 91–3, 198, 284 and abstention principle 65–72 and biodiversity 225–39 and law 8, 63, 104 and normative challenges 19–41 and Sanitary and Phytosanitary Measures 166 and supportive framework 232 criticisms of 5–6 definition of 37 hierarchical conceptualization of precautionary policy 105, 106 history of 2–6 international precautionary obligations 188 normative dimensions 19, 20, 22–34, 36, 39, 127 rationale for action 23 see also judicial review precautionary risk assessment 204–8 precedent 154 precipitation 247, 248, 250 precision of estimates, misleading 53 predator species, impacts on 191 predictions 162, 99–101 preference registering 127 presumption of innocence 139 prevention 44, 68, 92, 122, 145, 161–2, 304–5 price reduction 102 pricing mechanisms 89 prima facie case 141 principle, duty to consider 194 Principle of Abstention 64–72, 81, 84 principle, role of 202 priority, differences of 161 privatization 95 probabilities 143 balance of 100, 151 of high impact events 258 probability 28, 65, 141, 154–5, 162, 205, 261, 287 damage 171 quantification 287 spread of disease 171 testing 50

330 procedures, systematic 205 product standards 178 production expansion 175 prohibited substances 146 prohibition 237 because of risk 66 of existing activity 198 proof 141, 148, 189 burden of 26, 66, 84, 92–3, 99–101, 137–59, 272–7 levels of 39 of damage 54, 55 of safety 52–3, 84, 162, 206 persuasion, burden of 297 principle of 156 proponent and burden of proof of safety 162 requirement to prove absence of damage 66 reversed 7, 72 scientific 144 standard of 7, 8, 137–59 property responsibilities 90 property rights 90, 92, 96 property rights instruments (PRI) 102 proportionality 65, 68, 81, 128, 165, 285 prosecution, power of 141 prospects 103–6 protection 298 levels of 20, 24–5, 28, 33, 37–9, 165, 175, 254–60, 286 see also consumers, protection of; environmental protection protectionist strategies 233, 236–7 protectionist trade measure 25 protective measures 174, 205 prudence 272–7 public administration 100, 114–19, 123 role of 129, 131 see also administration public authorities 10 public consultation 204, 208, 213 public decision making 2, 4, 7, 11, 75 public expenditure 95 public goods 83 public health 2, 73, 173 laws 164 policy 42–62

Index problem 7, 9, 124, 128 protection 131 public input into risk assessment 211–13 public international law 166 public involvement 44, 94, 100, 106, 207, 216, 265 in risk assessment 211 participation in decisions 127, 235, 298 public perceptions 179 public policies for sustainable development 75 public reason 285 public responses to GMOs 207 public written submissions 214 purpose, unauthorized 194 qualitative methods, undervaluing 51 quantifiability of risks 260 quantitative assessments 142 quantitative restrictions in trade 163 quantitative techniques 286 quarantine 153 Quarantine Act 1908 154, 155 quarantine measures 163, 178 R v. Favre [1999] 158 rainfall increase 250; see also precipitation Ramsar Guidelines on Management Planning for Wetlands 240 rare species, demand for 236 RARMP, see Risk Assessment and Risk Management Plans rational methodology 131 real chance 152 reasons not to take action 224 rebut 140 of presumption of intention 147 recklessness 154 recreational benefits 223 reef dynamiting 236 regional development plans 93 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) 278 regulation 8 of use 146 precautionary 31–4

Index risk-based 34 uncertainty-based 34 regulatory assessments 211 regulatory bodies 213, 214 regulatory consistency 174 regulatory decision making 296 challenges to 57 regulatory design 147 regulatory experts 204, 207 regulatory frameworks 203 regulatory impact assessment 126 regulatory intervention 30, 189 regulatory obligations 147 regulatory systems 35 regulatory tests 71 releases of GMOs, possible effects of 30 reproduction 253 reprotoxicity 294 research and development 95 and monitoring 105 for risks 72 mono-disciplinary 57 short-term 57 speculative 58 uncontroversial 57 research methods 46 innovative 46 research projects 285 research questions, manageable 51 residues 169 resilience 263–4, 302 resistance, potential 208 Resource Assessment Commission, Australia 98, 99 resource development 104 resource exploitation 175 resource rights 96 resources 144 and environment 95 financial 98 human 98 respiratory systems 48 restriction of fishing licences 183 right to information on environment 75 Rio Declaration on Environment and Development 3 formula 202, 203, 204, 209, 218, 289

331

risk analysis 286 Risk Analysis Framework (RAF) 209–10 risk appraisal processes 8 risk assessment 28, 30, 38, 46, 57, 105, 125–6, 131, 145, 171, 178, 202–8, 211, 216, 286 decisions 36 definitions 169 inexact methods 55 management plan and 209 methodology 128 narrow 213–15 obligations, SPS 170 Sanitary and Phytosanitary Measures (SPSA) 172 sound science and 169 standard practice 5 threats of 189 Risk Assessment and Risk Management Plans (RARMPs) 210, 214, 215, 218, 219 communication 125, 286, 287 risk-averse and risk-seeking 195, 254 risk-based approach 205, 206 risk-informed strategy 303 and precautionary principle 260–66 and proof 84 and stakeholder involvement 308 and standards 34 in France 64 procedures 105 risks 14, 35, 42–3, 49, 70–72, 99, 131, 164, 288–9, 291 actual 39 caution 236 communication 125, 286, 287 considerations 69 determination 154 eradication 78 GMOs 26 hypothetical 2 identification 161 in Europe 9 levels 24, 254, 255 minimal level 169, 20 perception 39, 161 quantitative risk 91 uncertainty 90 unquantifiable 29

332

Index

risk management 21, 27–32, 76, 77, 79, 84, 125–7, 170, 203, 286–7 and hazards 65 hypotheses 68 potential 47 uncertain, discounted 53 understanding of 45 river health 102 road development 89 rules and regulations 145 rural communities 103 safe level of risk 255 safe minimum standards 105 safety 173 and GMOs 26 by default 54–5 concerns 210 levels 55 measures 164–5 significant risks to 212 ‘sufficient demonstration’ 32 salinity 102, 250 salmon 181 import ban, Australia 174 salmonella 295 Sanitary and Phytosanitary (SPS) Agreement 63, 125, 66–72, 160, 165, 177, 232 sanitary crises 72 sardines, trade description 181 satisfaction 142 scenario analysis 289 science 5, 7, 29, 33, 42–62, 95, 124, 127, 173, 208, 211, 264 decision making 8 environmental policy 55–9 epistemological problems 115 GMOs and 215 important role 44–5 innovative powers 160 lack of interdisciplinary approaches 55 limitations 53 ontological problems 115 political cover-ups 53–5 precautionary principles and 45–9 relationship to precautionary principle 42 risk assessment and 178, 284–315

slowing precautionary action 49–53 ‘sound science’ 3 technologies, new, and 280–81 traditional, and policy 53–5 transdisciplinary approaches 265 science-based decisions 39, 150, 169–71, 203, 289 science education 55 science fiction 276, 277 science for protection 179 science/policy interface 21, 36 scientific analysis 129 scientific burdens of proof 100 scientific certainty or not 137, 140, 225 scientific consistency 68 scientific controversy 21, 23, 28 scientific credibility 103 scientific data 125, 126, 156, 178 scientific development 69, 73, 93 scientific disciplines 99 scientific enquiries 49–53, 170 scientific evaluation 38, 39, 126, 211 scientific evidence 23, 139, 141, 166–71, 196 scientific information 30 34, 38, 144, 147, 198, 206 scientific innovation to protect the environment 75 scientific investigations 50 scientific judgements 213 scientific justification 163, 168–9 scientific knowledge 287 about risk 207 lack of certainty 28–34, 84 limited 204, 205 new 123 scientific material, evaluation 205 scientific methodologies 207 scientific methods, limitations in 52–3 scientific opinion 213 scientific requirements under GATT and TBTA 173–4 scientific research to protect the environment 75 scientific risk assessment 203 scientific standard 142 scientific terms of risk 143 scientific uncertainties 4–5, 9, 20, 23–4, 29–37, 65, 89, 92, 115, 119, 125–31, 161

Index and alternatives to asbestos 168 and decision making 154 and preventative action 228 as negative 53 as postponement 184 on climate change 245 on GMOs 202, 204 insufficient 193 lack of 151–2 threats and 294 scientific understanding, high level 189 scientists 204 perspective of 211 screening 291, 292, 293, 294, 295 screening criteria in food regulation 295 sea ice 250 sea level changes 245, 247–8, 251–3, 256, 259 sea lions excluder devices in nets 197 life-threatening injuries 197 mortality 196–7 sea turtles 227, 234 Second International Conference on the Protection of the North Sea (1987) 3 Seltsam Pty Limited v. McGuiness (2000) 158 Senate Committee procedures 145 sharks 227 fins 199 side effects, unintended 78 significance of effects 212, 213 skills, specialist 97 skipjack tuna permit 191 social consequences of GMO 215 social goal 104–5 social importance of effects 212 social need, overriding 297 social science 95, 99, 124 social sustainability 233 social values 47 socio-economic concerns 94, 103, 216, 234–5 socio-political culture 130 soil erosion 230 soil generation 223 Sol Theo v. Caboolture Shire Council [2001] 159

333

solutions 57–8, 263–4 sovereignty of member states of EU 80–83 soybean trade 231 specialist disciplines 291 species conservation 226 diversity 223 extinction 249, 253–4 accelerated 245 interaction 224, 229 loss 223 numbers 224 threatened 224 trading 226 species-rich habitats 224 sperm production 48 spiritual benefits 223 SPS Agreement, see Sanitary and Phytosanitary (SPS) Agreement squid fishery closure appeal 196 Squid Fishery Management Company Limited v. Minister of Fisheries 196 stabilization level 255 stakeholders groups 208, 230, 285 knowledge 265 participation 211, 305–7 standard of proof 137–55, 189–90 Briginshaw 152 civil 142, 143 criminal 142 precautionary 143, 144, 156 see also proof standard tests 72 standards, choice of 33, 34, 35 state enforcement 237 state government in Australia 128 state sector 96 statistical approaches 142 statutes 146–8 statutory authority 98 statutory obligation 155 statutory provision 152, 156 sterility 32 stock levels of fish 195 storms 248 strategic environmental assessment (SEA) 93, 94, 103

334

Index

subjectivity 161, 189 subsidiarity 63, 310 substance banning 27 restriction 146 substantive provision 186 sufficiency threshold 164 surprise theory 262 sustainability 39, 88–109 assessment (SA) 93, 105, 177 sustainable development 74, 103, 104, 186, 233 SwissRe 273 Tanimbar corella Cacatua goffini (bird) 236 tariff barriers 164 Tasmania 175 tax systems 95 taxation 93, 95 TBT Agreement, see Technical Barriers to Trade Agreement (TBTA) Technical Barriers to Trade Agreement (TBTA) 160, 165, 173, 177 technical data 144, 213 technical regulations, criteria 165 technicalities of implementation 8 technological development 76, 78, 230 technological innovation 73, 160 technological options, safer 45 technologies new 203 potential effects of 205 technology assessment (TA) 93 and foresight 35 temperature increase 248, 255 extreme 257, 258 maximum 256–9 temperature rises 24–5 terminology of the precautionary principle 37 terrestrial biodiversity in forests 231 testes, toxicity of phthalates 48 testimony, reliability of 144 testing requirements 163 Thailand – Restrictions on Importation of and Internal Taxes on Cigarettes 181 thermal expansion of sea water 251 thermal inertia of oceans 248

Thermohaline circulation (THC) 250–51, 262, 263 shutdown 249, 250 threat 119, 187, 195, 204, 230, 289, 291–8 biodiversity 224 environmental 121, 122, 152 irreversible damage 137 serious 189, 300 threshold 28, 139, 188, 292, 294 threshold test 139, 182–201 Australia 189 enforceability 193_5 legislative objectives and 195–8 Timbarra Protection Coalition Inc. v. Ross Mining NL 159 timber resource exploitation 231–2 time restraints 51 tolerance levels 178 tools and techniques 105 tourism 231 toxic chemicals 230 toxic substances exposure to 51 listed 47 toxicity of chemicals to humans 229 toxicogenomics, investment in 58 toxicological data, lack of 54 toxicological studies 278 toxicology 205 toys and phthalates 48–9 trade 224, 231 bans 227 barriers 163, 164 disputes, transnational 4 in food products 264 in goods 162 in wild species, domestic measures 227, 237 impact on 167 liberalization 175 obligations 2, 4, 163 trade agreements 95, 102, 179 new 176, 177 trade-off against potential benefits 101, 206, 212 trade, protectionist measure 25 trade reforms 177 trade regulation 227 trade restriction 27, 81, 164–5, 167, 176

Index trade-restrictive measures 166, 173, 174, 179, 240 trade rules 82 trading in species 226 trading partners, restrictions 163 tradition and use of fauna and flora 234 traditional knowledge 99, 170, 238 transboundary impacts 177 transdisciplinary deliberation 304 transgenes 24, 30 transparency 127, 164, 285 transplants 175, 231, 277 Treaty Establishing the European Union 4 Treaty of the European Communities (1992) 124 tree seed cycles in forestry 256, 261 trial 140, 141 trial judges 145 trophy hunting 237 tropical forests 231 tuna fishing restriction in imports to US 181 shark fins 199–200 Tuna Boat Owners Association of SA v. Development Assessment Commission & Conservation Council of SA 191 UFC-Que choisir 74 umbilical cords of newborns 49 United Nations (UN) 25 United Nations Conference on Environment and Development (UNCED) 3, 231–2 United Nations Millennium Ecosystem Assessment (2005) 253 uncertainties in decision making on GMOs 216 uncertainty levels, acceptability of 207 uncertainty, relationship with scientific uncertainty 96, 99, 119, 143, 145, 154, 185, 224, 235, 287 climate projections 248 complex 207 coping with 260–62 epistemic 28, 30 extent and nature of 229, 277 precaution and 303, 304

335

qualitative and variable forms 91 recognition of 91 risk assessment 205–6 scientific 29–30, 53, 54, 144, 205, threat in biodiversity and 229 unilateral measures 82 United Kingdom beef exports 82 United Nations Conference on Environment and Development (UNCED) (1992) 225 United Nations Fish Stocks Agreement (FSA) 227 United Nations Forum on Forests 232 United National General Assembly 159 United States and polybrominated diphenyl ethers (PBDEs) 49 and precaution 43–53 United States-Australian Free Trade Agreement (FTA) 101, 102 United States Congressional Briefing on Science and Precaution in Environmental and Public Health Policy 59 United States Endangered Species Act 238 United States Environmental Protection Agency 54 United States Food and Drug Administration 53 United States National Institutes of Environmental Health Sciences (NIEHS) 58 United States Occupational Safety and Health Administration 54 United States Office of Technology Assessment 98 United States regulatory regimes 9 United States Restrictions on Imports of Tuna 181 United States Toxic Substances Control Act (TSCA) 55, 56 urban sprawl, impacts 51 urbanization 224 Uruguay Round Commitments 176 value judgements 208 vegetation, destruction of native 89 vegetation patterns 246

336

Index

Velevski v. The Queen (2002) 159 Vellore Citizens Welfare Forum v. Union of India 16 Villach Bellagio target 255, 256, 259 violation of level of protection 24 voluntary initiatives for restriction 56 vulnerability of species 259 vulnerability science 52, 262 warming maximum allowable 256–9 waste decomposition 223 waste dumping 30, 47 water balance of forests 263 catchment 102 density 250 extraction 102 filtering 223 management 90, 102 policy reform 101 rights trading 102 watersheds 230 ways of life 231 weather, extreme 249 weed management practices 215 West Antarctic Ice Sheet 249, 252 wetlands 225, 230, 239 wildlife European 240

international trade 226–7, 233 trapping and shooting 230 wind reduction 250 Wind Turbines, CMS Resolution 240 Wingspread Conference on the Precautionary Principle (1998), US 44, 84 World Conservation Congress-IUCN (2004) 117 World Health Organization 4, 25, 63, 118, 125, 160–81, 177 World Trade Organization adjudication 162–75 agreements and precaution 179 and precautionary principle 7, 232 trade-restrictive measures 240 see also Sanitary and Phytosanitary (SPS) Agreement World Trade Organization Appellate Body (AB) 160 World Trade Organization law 9 World Trade Organization, undertakings 175–9 worst-case scenarios 66, 261 World Wildlife Fund International 177 zero risk 69, 74

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