Regulatory Futures: What Can STS Contribute?

Review of Roland Bal and Willem Halffman (eds.), The Politics of Chemical Risk. Scenarios for a Regulatory Future. Dordrecht, Boston, London: Kluwer Academic Publishers 1998, 367 pages.

In many Western countries in recent years, public authorities have been faced with major crises of credibility regarding their ability to adequately manage environmental and public health issues, based predominantly on scientific and technical advice. In controversies concerning BSE or transgenic products, for example, the relationships between science and politics have been at the center of the debate. These controversies have clearly indicated that uncertainties in science impose limits to political or regulatory solutions rationalised on technical grounds. Additional evidence indicates that public trust is a pre-condition for effective decision making. These notions, which have been acknowledged by STS researchers for at least two decades, have recently become more distinct to the public, and hopefully also to policy makers.

The Politics of Chemical Risk. Scenarios for a Regulatory Future, edited by Roland Bal and Willem Halffman, has chosen a more traditional theme than the regulation of BSE or of transgenic products. It inquires into the relationships between risk assessment (science-based evaluation), and risk management (policy-oriented or regulatory decision). Analyses of the tensions at this interface are undertaken in the light of a variety of national and international regulatory systems and cultures, with different styles of using science, and different ways of doing politics. Although the theme is not unusual (in the editors’ own words), the perspectives from which the authors look at it are, in my view, rather innovative. The book indeed brings in new insights and thoughtful theoretical and policy-oriented suggestions for a regulatory future in the area of chemical risk that may be of use for both social and policy researchers, and regulators in this, as well as in other public policy areas.

In their introductory remarks, the editors recall that the separation between science and policy in the evaluation of chemical risk has been instrumental, particularly since the 70s, in the legitimation of the regulation of chemicals. Social analysts, however, have questioned this separation by focusing on risk assessment and management as social constructs. One basic proposition of this book is exactly to combine the approaches from the natural and the social sciences, with a view to improving the regulation of chemical risk. In promoting the building of such a bridge, the endeavour of The Politics of Chemical Risk. Scenarios for a Regulatory Future appears to be much in line with present efforts within STS studies to put social research to practical policy use.

The book is based on a workshop. Its contents, however, represent more than just a record of proceedings . The volume contains a collection of original papers authored mainly by academic researchers, but also by regulatory scientists, and public administrators. The editors’ work in the structuring and balancing of the book’s contents, and in introducing constructive suggestions for improving regulation, deserves special reference. Parts I, II and III are preceded by an introduction, and succeeded by a summary of the discussions that followed the presentation of the corresponding papers at the workshop. Part IV consists of a reflection on scenarios for regulatory policy. At the end of the book, the editors tell us the story of the rationale, the organisation, and the dynamics of the workshop, in a set of very useful and inspiring notes.

Part I addresses the Risk Assessment/Risk Management boundary, a topic which in fact pervades the whole book. Part II looks, in a comparative perspective, to the National/International arenas. Part III’s object is Standardisation. Part IV, authored by the editors, presents the Scenarios and Reflections for a regulatory future.

Most of the articles included in this volume provide evidence that scientific data used as a basis for chemical risk regulation, despite their apparent (quantified) precision, and the rhetoric that often accompanies their use, are the result of presupositions and choices, and involve considerable uncertainties. As pointed out by Sue Mayer and Gillian Glegg, in the first paper of Part I, while ecotoxicology’s function has been to supply scientific data for use in decisions about chemicals control, by defining the amount of a chemical that may be discharged, seldom does sufficient data exist to carry out a complete assessment of both the chemical, and its receiving environment. Besides, the ways in which such uncertainties are interpreted are unknown, which obscures the boundary between risk assessment and risk management (p. 15). That notwithstanding, scientists themselves usually regard the establishment of relevant standards as a technical problem, away from politics and economics, and tend to minimise uncertainties (p. 19). This attitude is often coupled with a propension to give industry the benefit of the doubt (p. 20-21).

Following a similar line of argument, Mark Piney calls attention to the contrast between the rhetoric of the standard setting process for occupational exposure limits (OEL), that considers the health effects of toxic substances, and the fact that potential risks to health are balanced against the practicabilities of control (p. 48). The capabilities and costs of current control technologies and methods, current exposure levels, the technical and financial situations of the industry, the relative organisational ability and power of the groups involved in the OEL setting process, as well as the perceptions by the standard setters of the seriousness of the health effects — all these factors underlay the standard setting process (p. 55-56). Thus, political aspects clearly enter risk assessment.

The risk assessment/risk management divide is, after all, a myth , argue Mayer and Glegg, and the real question is how to have it recognised that choices behind risk assessment ultimately are political choices (p. 23). It would, therefore, be in the domain of democratic responsibility to make judgments about how much uncertainty over risk we wish to tolerate in relation to particular products and processes (p. 24). For the sake of clarity and effectiveness of regulatory procedures, Piney also claims there s a better separation to be made between science-based health-based standards, on the one hand, and reasonably practicable exposure limits and associated specification standards, on the other.

Roland Bal examines how organisational formats and mandates, what he calls the rationalistic repertoire , affect the role of different partners involved in the development of standards for occupational chemicals, thereby institutionalising the boundary between science and non-science. His history of the Dutch system shows that the institutionalisation of OELs definition and the setting of a structure where experts, interest groups and policy makers were represented, with no clear organisational boundaries between assessment and management functions, led, with time, to recognising the need for a neater boundary. This boundary became one of the main sources of the procedure’s legitimacy. But the need to find ways to deal with uncertainties in scientific data across that boundary remained (p. 86).

Part II addresses the political aspects of harmonisation of standard setting at European and international levels. The central issue here is the implications of Europeanisation and internationalisation of regulation for the risk assessment/risk management distinction. The starting assumption, as laid down in the introduction to this chapter, is that the European Union regulatory system seems to favour technocratic forms of expert advice (p. 117).

In the first article of this part, Vic Feron recognises that even relatively well structured systems, such as the Dutch system for the definition of occupational standards, are confronted with the difficulties raised by poor toxicological databases, procedure delays, and inconsistencies of evaluations. One crucial message coming out of this paper is the importance of the experts’ experience (a different concept from that of expert knowledge), and open-mindedness to compensate for those limitations, both in the national and the international instances (p. 128). The author’s belief in the wisdom of experts and their capacity to promote understanding and, ultimately, the required consensus in risk assessment, across communities and nations, does not seem to depart much from the concept of epistemic communities . This notion, which has been helpful in explaining the role of scientific expertise in international organisations, might, in my view, also provide insights into the role of expertise inside EU regulatory committees.

Like Roland Bal in Part I, Karel van Damme also takes an institutionalist approach to focus on two different legal frameworks under which standard setting is carried out within the EU: Articles 100 and 118 of the European Union Treaty, which deal respectively with the harmonisation of regulation in the single market, and with health protection of workers under the EU social policy. Whereas under Article 118, a clear separation between health-based and feasibility considerations appears to be guaranteed, under Article 100, the provision of scientific advice for the classification and labelling of chemicals is largely dependent on the industry (p. 148). The comparative study of the two procedures leads the author to conclude that risk assessments under Article 118 better meet the criteria of objectivity, impartiality and non-neutrality (to protect public health), than Article 100. Article 100 procedures are criticised, in particular, for facilitating the dominance of manufacturers, with the exclusion of certain sciences, as well as certain publics , and to be more prone to political pressures.

The contribution by Robert Nilsson brings in the special case of Sweden, and the tensions that the social and political features of this country are beginning to raise for EU standards harmonisation. Environmental extremism, with low levels of acceptance of risks, and a highly centralised and powerful regulatory system, have led Sweden to introduce a number of chemical bans and regulations with no parallel in other EU countries, and the EU (p. 162). Stringent controls on industry, in particular, depart considerably from the common trend in the EU. As other papers in this book show (e.g. Mayer and Glegg, and to some extent also Irwin et al.), uncertainties involved in risk assessment tend to be interpreted so as to favour industrial interest. Not surprisingly, differences between the regulatory practices of Sweden and the EU have been at the core of political tension. Nilsson believes that Swedish participation in the EU will lead to a better balance of power (in favour of industry, in this case) between regulators, citizens, and industry.

Sheila Jasanoff attempts to answer the difficulties of harmonising standards across countries and cultures by putting forward a suggestive concept of harmonisation as reciprocal commentary . By reciprocal commentary she means the exchange, among partners in this process, of qualitative (not only quantitative) information about prior practices, through feedback mechanisms that may enable appreciation of successes or failures across countries, thereby promoting cross learning and understanding of institutions’ culture and history (p. 174). Lessons drawn from constructivist analyses could, in her view, serve to improve standard setting processes, particularly in international contexts marked by greater socio-cultural, economic and political differences among partners (p. 186). Letting the messiness of politics back into harmonisation , concludes Jasanoff, may well be more productive in many cases than leaning too hard on the supports of science - especially at a time when science is faced with a problem of credibility, one might add.

Part III begins with Patrick McCutcheon’s description of the standardisation of tests and assessment protocols for the regulation of chemicals at European level. The author focuses on the procedures for delivery of data by industry, the selection of priority substances according to relative risk, the evaluation by rapporteurs, and the function of governmental committees (p. 220). McCutcheon’s central point is the role of expert judgment throughout all this process.

Irwin et al. address the workings of regulatory science in the field of agro-chemicals in the United Kingdom, under the impact of European regulation. Regulatory science, the authors argue, presents a number of special features, namely its location, its ethos and its contents. As could be expected, the institutional location of regulatory research is industry. This institutional context shapes the ethos of this kind of research (p. 245). The consequences of this status quo for the intermingling of science and economic interests are not hard to perceive. The traditionally secretive and informal nature of the British regulatory system, and its close relationships with the private sector, seem to have helped the features of U.K. regulatory research to survive for a long time. The authors, however, point to the impact of the EU regulatory environment on U.K. firms. These firms have had to adapt their practices in order to comply with the more formal and demanding requirements of European harmonisation.

Peter Calow goes further into the deconstruction of risk assessment. Before any risk assessment can be undertaken, the author recalls, a number of preliminary management decisions must be made, namely on what to protect, how far to standardise, and which tests to select. The same is true for the choice of habitat and species where tests are to be applied (p. 254). In spite of this, the author observes, the technical community is actually the one who takes most of these decisions. For Calow, the challenge, therefore, is to enable informed and useful input from all interested parties on either side of the technical divide, in accordance with the principles of permeability and transparency.

Based on examples taken from environmental risk assessment of chemicals in the Netherlands, the UK and the US, the last article of this volume, authored by Wilhem Halffman, centers its attention on the issue of trust, particularly on standardisation as a trust device. Standardisation of risk assessment methodology should be regarded as more than a merely technical affair, stresses Halffman. It also should be viewed as a means to establish trust among experts (p. 267). Here again, one is faced with a contrast between rhetoric and practice. Even though the standardisation of the environmental hazard of chemicals is generally presented as a technical affair, this does not imply that there are no expert judgments, which are not technical judgments, to be made.

Without wanting to diminish the solid technical reasons for regulatory scientists to standardise toxicity tests, Halffman’s paper argues that a sociological approach offers additional insights that could help to understand how standardisation works or does not work. Halffman emphasises that the process of establishing trust among experts has very similar traits to the process of establishing trust in experts, by those who are not members of the institutions of risk assessment (p. 267). This kind of comparison might be useful to understand sources of mistrust and contestation.

As this very brief and selective summary of contents indicates, consensus emerged among the contributors to Politics of Chemical Risk regarding the usefulness, for the regulatory process, of maintaining (or establishing) the separation between the risk assessment and the risk management functions. Most authors also agreed, however, that uncertainties in science, and the social and political basis of scientific assessments should be made more explicit and transparent than is often the case. Most papers also seemed to accept that the actual alternative is not between basing harmonisation efforts just on science, or understanding cultural differences and rationalities with the assistance of social scientists. It is rather in a compromise among the two kinds of action.

Drawing upon suggestions from the various papers, the editors attempt, at the end of the book, to map different scenarios for the future development of chemical regulation. Four possible scenarios are presented, in a reflexive and imaginative, though somewhat schematic manner, with particular reference to the EU (p. 310 ff.). In scenarios 1 and 2, regulation is centralised at the international or European level. In the first of these scenarios, regulation relies on a corpus of international experts belonging to a European Agency of Chemical Regulation . Under this scenario, the boundary between risk assessment and risk management is very marked. In scenario 2, labelled European risk consultation , a European Office of Chemical Assessment centralises the risk assessment process. The boundary between science and politics is looser. International political decisions are based on expertise in the context of an open process.

In the two remaining scenarios, by contrast, member states play the major role. In scenario 3, called European Coordination of Assessment , EU expertise is provided mainly by member states, the role of the EU being to harmonise standards in committees that represent national institutions. Expertise and the national context, therefore, intermingle. Scenario 3 is apparently closer to actual European regulatory practice. In scenario 4, Europe, through the European Office of Constructive Risk Assessment acts as a translator : differences in regulatory styles and in views on risk from different countries and interest groups are the starting point for European action. Various risk assessments are compared, and ultimately standardisation is lacking (p. 317).

The authors conclude that there are good reasons to maintain a division of labour between the domains of science and policy. To politicise every technical detail would, of course, increase conflictuality. Conversely, regulatory decision-making that is relegated to experts would lead to uncontrollable technocracies, as actual crises on BSE or transgenic products do confirm.

Regulators in the field of chemical risk, as well as in other fields of public regulation, in both national and international agencies, can find, in these propositions, valuable information for reflection and action aimed to improve the theory and practice of regulation.