"Regulatory Science": Industry, academic research and the European control of chemical toxicity
(Theme 1: European Regulation and the Science Base)
Dr Alan Irwin
Ms Elaine McCarthy
Dr Henry Rothstein
Prof Steven Yearley
The project is aimed at an integrated analysis of regulatory culture, research management and scientific practice using a single illustrative case area, agrochemical toxicity. As well as investigating this particular case, the project throws light on the general character of regulatory science. The project investigates how the design of regulation, especially at the European level, relates to the science base and whether growing regulation leads to the development of regulatory science. It asks howone should best characterise regulatory science: as simply a new application of science or an area with distinct cognitive and institutional practices of its own. The project also studies innovative alliances between industry and academic research and examines how regulatory science feeds forward into the regulatory process.
The study investigated the case of agrochemicals as a sub-set of toxic chemicals, focusing in particular on the relationship between European regulatory activities in this area and the emergence of new science and science policies. The case of the agrochemical industry is particularly interesting because the European Crop Protection Directive (91/414) is likely to have long term effects on the type and organisation of scientificwork in this sector.
The study examines the variety of actors and agencies that are involved in science for regulatory purposes in the agrochemical sector. Interviews were conducted with regulatory affairs managers and toxicologists in leading R&D-performing; agrochemicals companies located in the UK; with managers and researchers in a sample of university centres; with managers and technical personnel in consultancy firms and private laboratories; and with leading staff in the Pesticides Safety Directorate (PSD) and other government departments and agencies (DoH, DTI, HSE) and in DGs III, VI and XII of the European Commission.
The study produced findings of two main sorts. (For a fuller account see: Irwin et al, 1997) First, it became clear that regulatory science is a complex and many-sided activity. Based on the interview responses, a five-fold classification of regulatory science was produced:
- Speculative Research:
Speculative research is taken to embrace basic academic research on subjects which may have regulatory relevance such as chemical toxicity or environmental hazard.
- Development and Validation of Regulatory Tests:
Whilst hazards associated with the use of certain chemicals may be identified as a result of basic speculative research, specific tests have to be developed and validated so that chemicals can be screened for potential hazards.
- Regulatory Compliance Testing:
This refers to the undertaking of screening tests by industry - although often in collaboration with various scientific services - as specified by regulatory authorities.
- Investigative Problem-Solving:
When positive results from regulatory compliance testing threaten to result in regulatory failure, further investigation may be pursued in order to identify whether results are false positives, or whether special circumstances suggest that the result is irrelevant to risk assessment.
- Regulatory Submission:
The final stage of the production of regulatory science is concerned with compiling the dossier of information for regulatory review and completing the in-house risk assessment.
It is important to note that there is no implication that these aspects of regulatory science occur in a linear order. Neither are they confined to different institutional locations. Instead, the results suggest that regulatory science brings together a nexus of actors, activities and institutions in subtle and novel ways. The cross-institutional organisational settings for research in this area, can be seen both as sites for scientific activities,but also as sites of activities which reflect, and are likely to influence and frame, policy.
Key detailed findings include an increasing integration of innovatory and regulatory compliance activities. The growth of regulatory scientific requirements has been accompanied by the development of specialised contracting and consultancy facilities and by changes in the intramural management of research in firms. Effectively, knowledge of present and immediate future regulatory demands is used as a filter to screen out efficacious but impractical innovations at an early stage. This has been achieved through a multi-disciplinary 'process-orientated' team approach which integrates scientists with other sections of companies, such as marketing, throughout the innovation process. Although firms operate in a European or even global market, regulatory scientific capacity is strong at the national level both because regulation is actually enacted by national authorities and because relations between firms, regulatory authorities and contractors (in the UK at least) have continued to be based on familiarity and trust. Accordingly, close institutional relations have developed between firms and particular contract labs and indeed regulatory agencies.
Universities have proven themselves less well adapted for participation in regulatory science than might have been anticipated at the outset. Requirements such as Good Laboratory Practice (GLP) present some barriers to entering this market for university departments. Academics may also be less interested in routine testing-work which counts for little in terms of universities' broader mission. Adopting the alternative strategy of undertaking speculative or investigative work of regulatory interest is more attractive from the viewpoint of boosting academic output, but it generates relatively modest investments and, in the average case, little impact on the regulatory environment. However, this is not to deny that larger firms may acknowledge the long-term significance of speculative research.
The second sort of finding concerns regulatory science at the EU-level. It appears that the harmonisation of regulatory rules does not lead to the even dispersion of regulatory science throughout the EU but has tended to concentrate testing in certain countries. The explanation rests on three socio-cultural factors. Some countries have high concentrations of the industry and so have good reasons to do a lot of the testing on 'Europe's behalf'; certain countries are the preferred locus for the what is seen as 'authoritative' testing; and certain countries' agencies have taken a high profile role in the international politics of test development. This has resulted in some unexpected developments. For example, it is widely believed that the requirement for the PSD to operate full-cost recovery as a result of its agency status, has encouraged it to adopt an entrepreneurial role. Furthermore, the PSD's recent expansion to meet regulatory demands has even resulted in it contracting out some of its review activity. This extension of the review process blurs some of the boundaries between contract laboratories and the regulatory agency.
As well as conducting 'regulatory science' in anticipation of future regulatory trends firms are also, perhaps more significantly, participating in the shaping and 'fleshing out' of regulatory regimes. Scientific managers in the major companies have been actively involved formally and informally in the development of regulatory requirements. As active participants in the developing regime they form a vital link between government and industry to ensure that industry acts in concert with regulators as opposed to having to react to, or second guessing, regulatory developments. This is suggestive of the complexity and subtlety of the social processes defining and shaping regulatory agendas and practices.
Implications for policy and practice
Overall, the reported research is significant for reasons both of policy and theory. In terms of policy, it throws light on how science is used to meet regulatory targets and how regulatory science influences the direction and formulation of new targets. Specifically, we propose ways in which these new types of research and research-management shape the form of regulation which comes to be developed and implemented. Rather than simply assume that this new area of science is a mere 'application' of traditional disciplinary research, we consider the possibility that it represents a fresh kind of scientific development. In terms of theory, it advances our understanding of how the cognitive tools of science can respond to the pressure for 'greening' and provides detailed case study information on the process by which science is moving from a primary focus on enhancing production to achieving regulation, a process referred to as 'expertisation' (Funtowicz and Ravetz 1992) or as the rise of 'mandated science' (Salter 1988).
The project has so far been disseminated to industrial, policy and academic audiences- for example, through a presentation to the regulatory affairs committee of the British Agrochemicals Association and a one-day conference held in July 1996 at the London School of Economics. Papers were also presented at a conference in Amsterdam organised by the University of Leiden Institute for Law and Public Policy on 'The politics of chemical risk: scenarios for a regulatory future' (December 1995); and at an expert meeting of the Office of Technology Assessment of the German Parliament in Bonn (February 1997).
Publications from the project to date:
A. Irwin, H.Rothstein, S. Yearley and E. McCarthy (1997) 'Regulatory Science - towards a sociological framework', Futures, 29 (1): 17 -31
Brickman, R, Jasanoff, S and Ilgen, T 1985 Controlling Chemicals: the Politics of Regulation in Europe and the United States Ithaca, NY: Cornell University Press.
Funtowicz, S and Ravetz, J 1992 'The good, the true and the post modern' Futures 24.
Salter, L 1988 Mandated Science: Science and Scientists in the Making of Standards Dordrecht: Kluwer.
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