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Three Decades of EU Risk Regulation Research

Published online by Cambridge University Press:  26 April 2017

Ellen VOS
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Abstract

For nearly three decades scholars have studied issues of EU risk regulation, first presented as regulation of safety of products and persons,1 later on as true issues of risk regulation. This short comment will give brief, and at times personal, insights into the development on scholarly thinking on EU risk regulation and sketch a few challenges for the future.

I. Exploring EU risk regulation

“Nothing can be absolutely free of risk. One can’t think of anything that isn’t, under some circumstances, able to cause harm. Because nothing can be absolutely free of risk, nothing can be said to be absolutely safe. There are degrees of risk, and consequently there are degrees of safety.”Footnote 2

In his memorable book Of Acceptable Risk: Science and the Determination of Safety, William Lowrance analysed the issues and procedures involved in measuring risk, judging safety, and determining standards through regulation. I read this book during the risk regulation course taught by Giandomenico Majone at the European University Institute (EUI) at the beginning of the 1990s. This book was highly instructive for me, unveiling the immense struggle of decision-makers in dealing with risks, dilemmas and trade-offs to be made, underlining that decisions on risks are about decisions to accept some risks and not others.

These insights were extremely helpful to me in understanding the complexities of EU health and safety regulation that I studied in the context of my PhD at the EUI in the 1990s, exploring rather unknown agencies (which were just starting to be created) and committees, characteristic of EU risk regulation. This PhD aimed to analyse and understand how the EU dealt with science and scientific advice to protect human health and safety whilst not forgetting about the internal market, whereby I examined three models: committees, agencies and standardization bodiesFootnote 3 . Studying the intriguing world of committees that were set up to deal with human health and safety was without doubt very rewarding and was, in those times, for a legal researcher like me, an extremely exciting undertaking. For it not only required me to study literature and legal documents, but also required me, in that pre-internet era (!), to knock on the doors of civil servants in Brussels to try to unfold the untold stories of the functioning of committees.

Committee-based decision-making in the field of foods, based on the scientific advice of scientific committees created by the Commission in the 1970s and composed of scientists nominated by the Member States, and after consultation with a committee composed of Member States, so-called comitology, seemed actually to function very well.Footnote 4 This led Christian Joerges and Jürgen Neyer to conceptualise this model as an example of deliberative supranationalism.Footnote 5 The propitious picture of committee-based decision-making, however, shattered after the outbreak of the BSE crisis in 1996. The serious shortcomings in the institutionalization of scientific knowledge within EU decision-making on uncertain risks and the secretive method of decision-making that were revealed by the Inquiry Committee of the European Parliament in 1997 investigating alleged contraventions or maladministration in the implementation of EU law in relation to BSEFootnote 6 led to a dramatic collapse of confidence in EU science-based decision-making and called for change.Footnote 7

The BSE crisis exemplified the complex and vital relationships between science and society and of the difficulties stemming from dealing with (scientific) uncertainty. It can likewise be seen as an example of “organised irresponsibility”, a legendary notion devised by Ulrich Beck.Footnote 8 The resulting extensive re-appraisal of the EU’s prevailing structures of risk regulation in the aftermath of the BSE crisis led to a fundamental change in the use of science or scientific expertise, also referred to as “regulatory science”Footnote 9 in EU decision-making. Whilst formally introducing the precautionary principle, the role of science no doubt obtained a pivotal place in decision-making, and risk assessment was separated from risk management, formalising herewith a linear process of risk regulation whereby risk assessment feeds directly into risk management.Footnote 10 Agencies were set up in the EU’s institutional structure to replace and absorb scientific committees in response to this and other crises.

Accordingly, today’s EU legal frameworks increasingly use science and risk assessment as the yardstick to measure and decide on for example the access of products to the EU market and thereby privilege processes of depoliticisation and scientification in order to rationalise EU decision-making.Footnote 11 They are based on a “meta-legal authority of science”,Footnote 12 rooted in the ideal of science as the objective arbiter. This trend of scientification is nowadays reinforced by the globalisation of economies and embedded in international trade rules, in particular the sanitary and phytosanitary rules of the World Trade Organization (SPS agreement) which base on science the protective measures aimed at health and environmental protection.Footnote 13

II. EU risk regulation research

The BSE and other food crises were not only key lessons of risk regulation for EU (and national) authorities, but also led an increasing number of academics to embark upon EU risk regulation, studying the role of science, uncertainty, decision-making and institutional reform. The continuous stretching of the frontiers of science in areas such as biotechnology and its applications in the food chain has fortified academic research. Unsurprisingly, therefore, risk regulation has become over the years a true field of research in the legal area.Footnote 14 Where the European Court of Justice recognized the precautionary principle as applying also to human health and safety in the BSE case,Footnote 15 and the Commission promoted this principle as a general principle of EU law, and against the backdrop of the dispute between the USA and the EU on meat produced with hormones,Footnote 16 the precautionary principle received abundant attention in academic literature.Footnote 17 The attention to the functioning and application of the precautionary principle has slowly faded away in the past years and increasingly attention is paid to the study of several policy sectors and products, such as the highly complex and politically-sensitive matter of GMO regulationFootnote 18 and nanotechnology.Footnote 19 Moreover, the growing need to regulate risks in other areas than the “traditional” area of EU health and safety and environmental regulation in response to, for example, the financial crisis and migration crisis and terrorist attacks, has led to academics to study these areas also.Footnote 20

Likewise, the complexity of risk regulation has equally necessitated in-depth disciplinary and multi- and interdisciplinary study of this field, and manifold studies have been carried out on the basis of an interdisciplinary approach. This has also pushed me into more multi- and interdisciplinary research. Collaboration with Michelle Everson has underlined the tension between the functionalist need for science-based decision-making and the wider demand for a form of public participation and transparency within risk governance structures.Footnote 21 Collaboration with Marjolein van Asselt has given invaluable insights about risk assessment and uncertainty. Together we have further developed concepts such as the uncertainty paradox and uncertain risksFootnote 22 which helped to understand EU regulatory and judicial decision-making in situations of scientific uncertainty. The writings of social scientists Ortwin Renn,Footnote 23 Marion Dreyer,Footnote 24 Andy StirlingFootnote 25 and Ragnar LöfstedtFootnote 26 all have been influential for this field of research and underlined the need for more interdisciplinary approaches to EU risk regulation. This challenge was perfectly taken up by Alberto Alemanno as the instigator of the European Journal of Risk Regulation, a publication that filled “a serious gap in the scholarly literature of the old continent”.Footnote 27 This Journal has wholeheartedly embraced the multi- and interdisciplinary approach to risk regulation and has vastly contributed to the flourishing of EU risk regulation and beyond in scholarly research.

III. Challenges

After almost three decades, the study of EU risk regulation has only gained in importance. “Old” questions in relation to legitimacy and accountability, transparency and participation in decision-making continue to be highly relevant. The role of science in decision-making by EU authorities and courts will continue to require our attention. The focus on science and the predominance of a linear process of risk regulation in EU legal frameworks whereby “risk assessors do the science ‘bit’ and risk managers the law/policy ‘bit’”Footnote 28 needs close consideration as this is problematic for various reasons. It inter alia would generate a de-legitimation of regulatory authorities and their decision-making processes as they outsource their political responsibility to risk assessors. It is, moreover, problematic as it fails to recognise the uncertain and provisional nature of scientific knowledgeFootnote 29 and the culturally constructed, socially-contested nature of risks.Footnote 30 This, therefore, surely requires further in-depth study.

The area of risk regulation research will also be extended in view of novel challenges for society in relation to terrorist attacks, as well as the rise of Big Data and the increasing importance of privacy and data protection confront us with “new” questions of transparency and secrecyFootnote 31 and risk regulation and governance.

Multi- and interdisciplinary research continues to be highly pertinent. Social sciences-legal research remains and will become even more relevant, whereby it is important that empirical, case-study research will inform and strengthen theory and vice versa.Footnote 32 Scholars have already started to explore other disciplines relevant to our understanding of EU risk regulation, in particular behavioural studiesFootnote 33 and nutritional sciences and toxicology,Footnote 34 the study of which will only increase in importance and which will be extremely challenging for researchers dealing with EU risk regulation in view of the highly distinctive nature of these disciplines. The European Journal of Risk Regulation will hence remain a vital forum to present and discuss scholarly research and important developments in practice.

Footnotes

*

Maastricht University, Maastricht Centre for European Law; email: e.vos@maastrichtuniversity.nl.

1 C Joerges, J Falke, H-W Micklitz and G Brüggemeier, Die Sicherheit von Konsumgütern und die Entwicklung der Europäischen Gemeinschaft (Baden-Baden: Nomos 1988), translations: European Product Safety, Internal Market Policy and the New Approach to Technical Harmonisation and Standards, EUI Working Papers Law Nos. 91/10-14: <http://www.iue.it/LAW/WP-Texts/Joerges91>; <http://hdl.handle.net/1814/73> and Hanse Law Review, No 2, Vol 6, Bremen: Hanse Law Review eV 2010.

2 WW Lowrance, Of Acceptable Risk: Science and the Determination of Safety (Los Altos, CA: W Kaufmann 1997).

3 E Vos, Institutional Frameworks of Community Health and Safety Regulation (Oxford: Hart Publishing 1999).

4 C Joerges, K Ladeur and E Vos, Integrating Scientific Expertise into Regulatory Decision-Making. National Traditions and European Innovations (Schriftenreihe des Zentrums für Europäische Rechtspolitik, Band 23) (Baden-Baden: Nomos 1997).

5 C Joerges and J Neyer, “From Intergovernmental Bargaining to Deliberative Political Processes: The Constitutionalisation of Comitology” (1997) 3(3) European Law Journal 273.

6 Temporary committee of inquiry into BSE, Report on alleged contraventions or maladministration in the implementation of Community law in relation to BSE, without prejudice to the jurisdiction of the Community and national courts, A4-0020/97.

7 E Vos, “EU Food Safety Regulation in the Aftermath of the BSE Crisis” (2000) Journal of Consumer Policy 227; D Chalmers, “Food For Thought, Reconciling European Risks and Traditional Ways of Life” (2003) 4 Modern Law Review 532.

8 See U Beck, Risk Society: Towards a New Modernity (SAGE 1986); id., World Risk Society (Polity Press 1999).

9 S Jasanoff, The Fifth Branch. Science Advisers as Policymakers (Harvard University Press 1990).

10 E Fisher, “Framing Risk Regulation: A Critical Reflection” (2014) 2 European Journal of Risk Regulation 125.

11 MBA van Asselt, M Everson and EIL Vos, “Trade versus health and the environment?” in MBA van Asselt, M Everson and EIL Vos (eds), Trade, Health and the Environment. The European Union Put to the Test (London: Routledge/Earthscan 2014) 3.

12 C Joerges, “Scientific Expertise in Social Regulation and the European Court of Justice: Legal Framework for Denationalised Governance Structures” in Christian Joerges, Karl-Heinz Ladeur and Ellen Vos (eds), Integrating Scientific Expertise into Regulatory Decision-Making. National Experiences and European Innovations (Nomos 1997) 320.

13 See, inter alia, J Scott, Commentary on the Sanitary and Phytosanitary Measures Agreement (Oxford: OUP 2007; paperback 2009).

14 See e.g., E Fisher, Risk Regulation and Administrative Constitutionalism (Hart Publishing 2007); M Lee, “Beyond Safety? The Broadening Scope of Risk Regulation” (2010) Current Legal Problems 242; A Alemanno, Trade in Food: Regulatory and Judicial Approaches in the EC and the WTO (Cameron May 2007); C Joerges, “Law, Science and the Management of Risks to Health at the National. European and International Level – Stories on Baby Dummies, Mad Cows and Hormones in Beef” (2000) 7 Columbia Journal of European Law 1.

15 Case C-180/96.

16 J Scott, “On Kith and Kine (and Crustaceans), ‘Trade and Environment in the EU and WTO’” in JHH Weiler (ed), The EU, the WTO, and the NAFTA (Oxford: Oxford University Press 2001) 125.

17 E.g., E Fisher, “Precaution, Precaution Everywhere: Developing a ‘Common Understanding’ of the Precautionary Principle in the European Union” (2002) 9(1) Maastricht Journal of European and Comparative Law 7; EC Fisher, JS Jones and R von Schomberg (eds), Implementing the Precautionary Principle: Perspectives and Prospects (Cheltenham: Edward Elger Publishing, 2006); P Harremoës, D Gee, M MacGarvin, A Stirling, J Keys, B Wynne, S Guedes Vaz, The Precautionary Principle in the 20th Century: Late Lessons from Early Warnings (London: Earthscan 2002); N de Sadeleer, “The Precautionary Principle in EC Health and Environmental Law” (2006) 12(2) ELJ 139; JB Wiener, MD Rogers, JK Hammit and P Sand (eds), The Reality of Precaution: Risk Regulation in the United States and Europe (Routledge 2011); M Haritz, An Inconvenient Deliberation: The Precautionary Principle’s Contribution to the Uncertainties Surrounding Climate Change Liability (Kluwer 2011); V Heyvaert, “Facing the Consequences of the Precautionary Principle in European Community Law” (2006) 31(2) European Law Review 185; G Majone, “What Price safety? The Precautionary Principle and its Policy Implications” (2002) 40(1) JCMS 89; J Scott and E Vos, “The Juridification of Uncertainty: Observations on the Ambivalence of the Precautionary Principle within the EU and the WTO” in C Joerges and R Dehousse (eds), Good Governance in Europe’s Integrated Market (Oxford University Press 2002) 253; D Vogel, The Politics of Precaution: Regulating Health, Safety, and Environmental Risks in Europe and the United States (Princeton University Press 2010); J Zander, The Application of the Precautionary Principle in Practice, Comparative Dimensions (Cambridge University Press 2010).

18 E.g., Maria Weimer, “Risk Regulation, GMOs, and the Challenges to Deliberation in EU Governance – Politicization and Scientification as Co-Producing Trends” in C Joerges and C Glinski (eds), The European Crisis and the Transformation of Transnational Governance – Authoritarian Managerialism versus Democratic Governance (Hart 2014); P Dąbrowska-Klosińska, “EU Governance of GMOs: political struggles and experimentalist solutions?” in C Sabel and J Zeitlin (eds), EU Governance: Towards a New Architecture? (Oxford University Press 2010) 177; M Lee, EU Regulation of GMOs: Law, Decision-making and New Technology (Edward Elgar 2008).

19 E.g., T Ehnert, “The Legitimacy of New Risk Governance: A Critical View in Light of the EU’s Approach to Nanotechnologies in Food” (2014) 21(1) European Law Journal 44.

20 E.g. H Micklitz and T Trimidas (eds), Risk and Law (Edward Elgar 2015).

21 M Everson and E Vos, “The Scientification of Politics and the Politicisation of Science” in M Everson and E Vos (eds), Uncertain Risks Regulated (Routledge/Cavendish Publishing 2009) 12.

22 MBA van Asselt and EIL Vos, “The Precautionary Principle and the Uncertainty Paradox” (2006) 9(4) Journal of Risk Research 313; MBA van Asselt and E Vos, “Wrestling with Uncertain Risks: EU Regulation of GMOs and the Uncertainty Paradox” (2008) 11 Journal of Risk Research 281.

23 See e.g., O Renn, “Risk Governance: Towards an integrative approach” IRGC White Paper No 1 (2006) International Risk Governance Council (IRGC), Geneva, Switzerland; O Renn and A Klinke, “A New Approach to Risk Evaluation and Management: Risk-Based, Precaution-Based and Discourse-Based Strategies” (2002) 22(6) Risk Analysis 1071.

24 M Dreyer and O Renn (eds), Food Safety Governance. Integrating Science, Precaution and Public Involvement (Heidelberg: Springer 2009).

25 Andreas Klinke, Marion Dreyer, Ortwin Renn, Andrew Stirling and Patrick Van Zwanenberg, “Precautionary Risk Regulation in European Governance” (2006) 9(4) Journal of Risk Research 373.

26 RE Löfstedt, Risk Management in Post-trust Societies (Hampshire: Palgrave Macmillan 2005).

27 G Majone, “Foundations of Risk Regulation: Science, Decision-making, Policy Learning and Institutional Reform” (2010) 1 European Journal of Risk Regulation 5.

28 E Fisher “Framing Risk Regulation: A Critical Reflection” (2014) 2 European Journal of Risk Regulation 125.

29 Idem.

30 S Jasanoff, Designs on Nature: Science and Democracy in Europe and the US (Princeton: Princeton University Press 2005).

31 D Curtin, “Overseeing Secrets in the EU: A Democratic Perspective” (2014) 52(3) JMCS 684; V Abazi, Secrecy and Oversight in the European Union. The Law and Practice of Classified Information, (CPI Koninklijke Wohrmann 2015).

32 See for this approach, MBA van Asselt, E Versluis and EIL Vos (eds), Balancing Between Trade and Risk. Integrating Legal and Social Science Perspectives (Earthscan Routledge 2013).

33 E.g. A Alemanno and A Sibony (eds), Nudge and the Law: A European Perspective (Hart 2015).

34 A De Boer, Interactions between Nutrition and Medicine in Effect and Law (Maastricht 2015).

* Maastricht University, Maastricht Centre for European Law; email: .