If No Risk Is Proven, Is There a Risk? Some Reflections on Risk, Science and Environmental...

If No Risk Is Proven, Is There a Risk? Some Reflections on Risk, Science and EnvironmentalRegulation in Ireland after Watson v EPA and MonsantoAuthor(s): George TaylorSource: Irish Studies in International Affairs, Vol. 17 (2006), pp. 99-114Published by: Royal Irish AcademyStable URL: http://www.jstor.org/stable/30002100 .

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If no Risk is Proven, is there a Risk? Some Reflections on Risk, Science and Environmental Regulation in

Ireland after Watson v EPA and Monsanto*

George Taylor

National University of lreland, Galway

ABSTRACT

There are few areas where risk, science and politics collide that are more controversial than genetically modified organisms. This paper places the findings of the Watson v EPA case heard in the High Court in Dublin in 1998 within the context of change wrought upon international institutional politics, where modern conservatism has challenged the state's responsibility for defining what is an acceptable level of risk. A neo-liberal agenda transpires in which science no longer underscores the regulation of the market through the state (the realm of the political/legal), but participates in the reconstruction of individual citizens as consumers of both products and their attendant risks (the economic/legal). In the event of catastrophe, the function of science is to participate in assigning negligence or culpability to market failure. More crucially, its role is not to prevent development on the grounds that it may be risky (because in all walks of life we encounter risk), but to define more clearly where a risk can be proven. And, if no risk can be proven, state intervention, or regulation that impinges upon a free market, cannot be justified.

INTRODUCTION

Take a glimpse at the following list: nuclear power, Thalidomide, Vioxx, genetically modified organisms (GMOs), dioxin release from waste incineration and the potential link between the mumps, measles and rubella (MMR) jab and autism. I'm aware that it's an emotive and contentious list, but having read it, ask yourself the following question: if no risk is proven, is there a risk? It's a thorny one to grasp, for, disparate though these topics at first appear, they all have at least one thing in common: they involve debates about risk that are circumscribed increasingly by the complex terminology of science. *The author would like to thank Lorraine Higgins BL, Kings Inns, for discussions on the legal themes explored in this paper, two anonymous referees and the editor of Irish Studies in Internationl Affairs, Dr John Doyle.

Author's e-mail: [email protected]

Irish Studies in International Affairs, Vol. 17 (2006), 99-114.



100 Irish Studies in International Affairs

Few would disagree that the role of risk in politics has emerged as an increasingly prominent and controversial topic.' Neither is there likely to be much disagreement that it is an area of debate where modem conservatives feel compelled to enter the political fray. Whether it is an American Republican, a British Conservative or an Irish Progressive Democrat, the argument runs that far too much weight has been accorded to the role of the state in 'deciding' what is in our best interests, and far too little consideration given to the individual's capacity to decide on potential risks. These were certainly issues that gained prominence when the ban on smoking in public places took centre stage in the Irish media.

Alternatively, for environmental activists (or those of a social democratic persuasion) unease with the manner in which risk and politics collide finds its roots in the way science has been used, to obfuscate rather than illuminate, in situations of uncertainty.2 As the public's anxiety has grown, and political protest has surfaced, government has chosen to side-step the issue(s), choosing to reassure through the media. To the utter dismay of environmentalists and social democrats, calls for greater participation or more stringent regulation are often seen as the cries of the heretic, anarchists or worse, green fundamentalists, out of touch with the imperative of sustaining a healthy economy.3

Irrespective of your political persuasion, the relationship between risk, science and policy-making appears to have come under intense scrutiny. And yet, it seems remarkable that whether the issue is Bovine Spongiform Encephalopathy (BSE), nuclear power or GMOs, political debate has been skewed by a view of science in politics that assumes the source of the problem (a relatively recent problem) to be the inability of the modern state to juggle (and communicate) the complex findings of a scientific community operating at the 'cutting edge'.

This paper seeks to challenge such a limited view of the role of risk in politics. It begins by examining the role of risk under the auspices of the interventionist

'Ulrich Beck has argued that industrial society has been supplanted by a 'risk society' in which science no longer possesses an overwhelming grip upon the public's imagination. A 'world-wide growth of large scale technological systems' has meant that the least likely event will occur in the long run. The technocracy of hazard: 'squirms in the thumbscrews of the safety guarantees which it is forced to impose on itself...the security system which anticipates social provision for the worst conceivable case, broke down with the advent of large scale nuclear, ecological and genetic hazards'. These hazards develop a momentum of their own and not only pose a threat to everyone, but also stand 'in contradiction to the state's institutionalized pledges of safety and welfare'. If industrial society revolved around the distribution of goods, then risk society is about how we distribute the 'bads'. It is a transformation that begins where nature ends, as we shift our concern from what nature can do to us to what we have done to nature. See Ulrich Beck, Risk society: towards a new modernity (London, 1992), 10. For some critical (if flawed) comments see Martin J. Smith, 'Mad cows and mad money: problems of risk in the making and understanding of policy', British Journal of Politics and International Relations 6 (2004), 312-32.

2This tends to draw upon the work of those such as Timothy O'Riordan et al. or Giandomenico Majone. O'Riordan et al. have argued that within rigid interpretations of positivistic science, which promulgate an ability to provide universal explanation, and where the importance of the rational is elevated, there is a tendency to explain uncertainty in terms of either a lack of knowledge, ignorance or the competing views of experts. The argument runs that when the public challenges the scientific process it is often found to 'fall short of the (unrealistic) formal, rule-bound images of scientific practice', leading to a deterioration in regulatory credibility. See Timothy O'Riordan, R. Kemp, and M. Purdue. Sizewell B: an anatomy of an inquiry (London, 1988), 128. See also Giandomenico Majone, 'The credibility crisis of Community regulation', Journal of Common Market Studies 38 (2) (2000), 273-302.

3The political furore that surrounded the Rossport Five springs to mind. In that case, a group of activists spent time in custody as a result of their protest against Shell's decision to develop a gas field in County Mayo. The activists were deemed to be in contempt of court for their protest.



TAYLOR-Risk, Science and Environmental Regulation in Ireland 101

state, where a number of arguments are put forward. First, that in its regulation of the market the interventionist state was always required to be keenly aware of the incomplete nature of scientific knowledge. Politicians (and civil servants) recognised that science was rarely absolute, that expert advice was refracted through political channels, subject to conflicting interpretation and that they were predisposed to acknowledge the importance of consultation in the policy process to offset the possibility of any legal challenge. Second, that the role of risk in politics was framed within a social democratic project in which altruism and solidarity were to the fore. Intervention was legitimate if it reduced the risks to health, welfare and employment while not imposing an excessive burden upon the free market. Third, that during the 1980s the first tentative signs of a reconfiguration of risk in politics emerged as the EU, the US and the UK sought to deregulate markets, reduce 'red tape' and allow the entrepreneurial spirit free reign. Within this conservative political landscape, institutional politics became increasingly predisposed to alter the relationship between risk assessment and its management (intervention/regulation).

The second section of the paper draws upon the work of Friedrich Hayek and details more extensively the modem conservative critique of social democracy and the role of risk in politics. Following Hayek's anti-rationalist beliefs, modern conservatism has argued that it is impossible for the state to decide what is an acceptable level of risk (and therefore has challenged the possibility that risk can be contained within the realm of the political/legal), given that it involves an attempt to balance competing and conflicting economic and social objectives. Where possible, conservative governments have sought to reduce regulation, increase the use of risk assessment to reduce intervention and, where this has not been possible, to ensure that regulation is justified on the grounds of 'sound science' or definitive expert advice. Science no longer underscores the regulation of the market through the state, but actively participates in the reconstruction of individual citizens as consumers of both products and their attendant risks.

In a subtle, but nonetheless crucial fashion, the role of science in regulation is about sustaining the view that 'risks' are an attendant feature of day-to-day life: that what matters is how, as individuals, we make judgements about those risks. Indeed, it seems increasingly evident that the function of science (and expert advice) is to articulate the extent to which individuals are exposed to risk or, to define more clearly, where no risk can be proven. This reconfiguration of risk in politics reveals the preference (and influence) of multinational capital, for which the role of science should be to determine definitively whether a product is detrimental to public health, thereby establishing negligence or culpability.

If the second section of the paper outlines the influence of modem conservatism in the reconfiguration of risk in politics, the objective of the final section is to show how this has impacted upon environmental regulation in Ireland. Here, the paper draws upon the controversial case of Watson v EPA and Monsanto, in which a member of Genetic Concern, an Irish NGO, attempted to halt trials for the use of GMOs in Ireland. Put simply, the final section of the paper argues that if we are to understand environmental regulation in Ireland more fully we need to acknowledge the manner in which risk has been reconfigured in both national and international institutional politics. Indeed, the case study shows that the ruling in the Watson case sits comfortably within a neo-liberal inspired vision, where the role of science is not to prevent development on the grounds that it may be risky, (because in all walks of life we encounter risk), but to define more clearly where a risk can be proven. And




if no risk can be proven, it cannot form the basis of legitimate (acceptable) intervention.

RISK, SCIENCE AND REGULATION UNDER THE INTERVENTIONIST STATE

For many social democrats the Keynesian vision provided the tantalising prospect of an electoral mandate, a succession of economic tools for an interventionist government and, in areas of social policy, a political argument to reduce (but not necessarily remove) the vagaries of the free market.4 This vision, which sought to qualify the free market, found a ringing endorsement in the work of those such as Titmuss, who had rejected the narrow interpretation of 'choice in welfare' to be found in liberal economic thinking.5 His fervent opposition to the unfettered forces of the free market was expressed most cogently in his promotion of a blood supply system based not on the 'professional donors from skid row denizens' to be found in the US, but on a system involving free donations. In advocating this system, Titmuss felt it would improve not just the 'choice of all' in welfare, but confirm that altruism and solidarity could form the basis for efficient state intervention. Socialism was about community as well as equality, and it was important to recognise and value each individual's contribution to that community.6

Titmuss's defence of state intervention carried force not only because it argued the case for efficiency, but also because it identified legitimate state intervention, or responsible government, in terms of its capacity to reduce the unpredictability and uncertainty of risk to unemployment, poverty, ill-health, homelessness or ignorance. It was not about providing the 'institutionalized pledges of safety and welfare' to which those such as Beck refer.7 Rather, it was about regulating (and thereby alleviating) the worst excesses of the free market. It was this that gave the interventionist state of the post-war period the imprimatur of the public. However, if we are to understand more accurately the role of risk in politics during this period, we need also to appreciate how it was refracted through the architecture of the state.

For many political commentators the relationship between expert advice and politics is presented in terms of a simple dichotomy: on the one hand scientists are responsible for risk assessment; a technical, non-political matter of gauging adverse effects on humans, plants and animals as a result of exposure to an agent. On the other hand, politicians have a responsibility for managing the risk identified by scientists, thereby setting the appropriate level of protection.8

Such an approach palpably fails to consider the way in which scientific advice is refracted though the political channels of government. In practice, the distinction between the objective pronouncements of science and the subjective interpretation of politics is often blurred. This is amply demonstrated in the evidence of one civil servant

4See Christopher Pierson, Beyond the welfare state: the new political economy of welfare (Cambridge, 1998).

51n areas such as medical care, Titmuss derided the work of liberal economists who failed to realise that consumers did not know in advance their needs, how much care would cost or what categories of medical care they would be purchasing. A free market would simply neglect and 'punish the indigent, the coloured, the dispossessed and the deviant'. See Richard Titmuss, 'Choice and the welfare state', in Socialism and affluence (Glasgow, 1967), 25-38: 38.

6Titmuss, 'Choice and the welfare state', 37-8. 7See Ulrich Beck, 'Risk and the provident state' in Jane Franklin (ed.), The politics of risk society

(Cambridge, 1998), 9-23: 12. 8See Grace Skogstad, 'The WTO and food safety regulatory policy innovation in the European

Union', Journal of Common Market Studies 39 (3) (2001), 485-505.




to the Philips Inquiry on BSE in the UK, where he noted that in certain circumstances advice given to a minister might be affected by the experts' 'understanding of the minister's current thinking'. Moreover, while an opportunity for debate meant that a particular 'line' could be challenged, once a firm decision had been made at ministerial level: 'it would have been very unusual to have advised ministers to think again, unless there was a factor which they had clearly not been able to take into account...'9

If the issue of ministerial responsibility often had an important bearing upon the 'political shape' that expert advice took, the channels through which communication travelled were also important. Due consideration was accorded to statements made by politicians, either in opposition or office. Indeed, those who did not 'draft things in a way that emphasised the benefits of government policies', would tend to be less popular.'0 While the relationship between ministers, civil servants and experts provided a political context in which advice was shaped, the communication of that information, whether to parliament or the public, was also important in the construction of policy. Once a minister had taken a certain line, public officials would be expected to follow suit. If the manner in which expert advice was refracted through the political architecture of the state questioned the level of scientific certainty that underpinned decisions, the nature of the regulatory principles adopted during this period also provide further grounds for caution.

During the post-war period, much of the legislation drafted by both the British and Irish governments operated with an assessment of risk that involved a number of regulatory principles that endorsed different views. In the UK's Health and Safety Act (1974), for example, the operating principle in relation to risk was ALARP (as low as reasonably practicable), and this act included the following wording: 'the injunction laid down in safety law that any risk must be reduced so far as reasonably practicable, or to a level which is as "low as reasonably practicable"'. Such principles were by no means new. In Ireland, the Alkali Works Regulation Act (1906), which borrowed heavily from its British counterpart, stipulated that works should be registered with the inspectorate and that the principle of 'best practicable means' would inform the standards for certification."

It is not simply that a plethora of regulatory principles existed, each with a subtle but nonetheless discernibly different slant on risk.12 Rather, they were premised upon the realisation that science was incomplete, that a government's defence would need to be: 'bolstered by regulations that were soundly based in law, were reasonable themselves, were consistent and had been subject to reasonable consultation'.'3

Such arguments run counter to the modern mantra that risk (or perhaps more accurately risk analysis) in politics is a purely recent phenomenon, emerging largely as a result of the state's inability to grapple with science at the cutting edge.'4 What

9Robert Lowson, cited in Lord Philips, June Bridgeman and Malcolm Ferguson-Smith, Report of the inquiry into BSE and variant CJD in the United Kingdom (London, 2000), 14. (Hereafter cited as Report of the inquiry.)

J"Lowson, cited in Philips et al., Report of the inquiry, 14. "'See Yvonne Scannell, The law and practice relating to pollution control in Ireland (London,

1982), in regard to the 1906 act. For the 1974 act see C. Hood, D.K. Jones, N.F. Pidgeon and B.A. Turner, 'Risk management', in Risk: analysis, perception and management (London, 1992),

121n those areas such as the licensing of medicines, or the assessment of food additives, the preference was to adopt the principle of NOAEL: no observable adverse effects level. If it involved the regulation of food contaminants, then legislation tended to endorse the principle of either ADI or TDI: acceptable or tolerable daily intakes.

'3Philips et al., Report of the Inquiry, 36. (Emphasis added.) "4See Smith, 'Mad cows and mad money'.




has clearly occurred over the last two decades is that the change wrought upon the interventionist state has effected a reconfiguration of risk in politics. The thrust of this change has been to deregulate markets, reduce bureaucratic 'red tape' and allow the spirit of free enterprise to reign. At both the national and international levels, institutional politics has been increasingly predisposed to alter the relationship between risk assessment and its management. Put simply, modern conservatives have sought, where possible, to remove or reduce regulation (intervention). Where resistance has been met, conservative governments have demanded that further regulation is made on the grounds of 'sound' or conclusive science.

By the late 1980s governments both in Europe and the US, as well as influential institutional bodies such as the Codex Alimentarius Commission (Codex),'5 had been deliberating upon the potential for risk assessment to reduce government regulation.16 Codex attempted to persuade the EU that risk assessment should be a scientific process consisting of the identification of hazards, the assessment of exposure and the characterisation of risk. Risk management was a process of weighing policy alternatives in light of this assessment and then selecting the appropriate controls and measures (regulation and intervention).

These were issues that clearly had an important bearing upon the emergence of two regulatory principles in the EU: proportionality and the principle of the 'best available technology not entailing excessive cost' (BATNEEC). Proportionality was a principle generally taken to mean not using a 'sledgehammer to crack a nut', and it was adopted to assess whether national regulations impinged inordinately on the free movement of goods." BATNEEC underpinned the Integrated Pollution Control (IPC) licensing system of both the Irish and British Environmental Protection Agencies.'8 Unlike the principle of best available technology (BAT), which had been mooted as the preferred option at the European level to underscore IPC licence applications, BATNEEC endorses a view of safety that involves a risk assessment that accords value to other objectives, such as wealth creation and international competitiveness. 19

It was not only in areas such as environmental regulation that the governmental interest in new forms of risk assessment could be seen. In the UK, a succession of documents emanating from the Treasury began to forge the view that it was a mistake to regulate against all risks and that regulation must be seen to be balanced and appropriate to the problem. In food safety, for example, ministers were adamant that regulators were placing burdens on industry that could not be justified in terms of the risks involved. As one of the UK government's veterinary service hygiene advisers observed: 'a wide understanding...of the standards that were required of

15For more information on this international organisation see Philip James, Fritz Kempler and Gerard Pascal, A European public health and food authority: the future of scientific advice in the EU (Brussels, 1999).

16For more detail on risk and food safety in Ireland see George Taylor, 'From the slurry to the curry: the politics of food regulation and reform in Ireland, Irish Studies in International Affairs 14 (2003), 149-65. See also George Taylor and Michelle Millar, 'The appliance of science: the politics of European food regulation and reform', Public Policy and Administration 13 (4) (2002), 125-46.

'7Philips et al., Report of the inquiry, 45. '8Over the years it has been more common for policy to be transferred from the UK to Ireland.

However, in this instance the Irish EPA was at the forefront of attempts to develop new regulatory principles that were influential in Europe. See George Taylor, 'Looking back (but not in anger): policy transfer and the role of institutional memory in the construction of the Irish Environmental Protection Agency', Irish Studies in International Affairs 13 (2002), 187-201.

19George Taylor, Conserving the Emerald Tiger (Galway, 2001). (Emphasis in the original).




the slaughterhouses.. .existed. However, ministers were insistent that there should be no gold-plating, and slaughterhouses should not be required to do more than was the legal requirement'.20

Principles such as proportionality and BATNEEC bore the imprint not only of a concern to reduce state regulation, but to realign priorities. The regulation of the environment and food safety would need to strike a balance between a level of safety deemed sufficient and other valued objectives, such as economic growth and free competition. Ultimately, this would reduce government responsibility, redefine the relationship between the state and the individual and ensure that regulation would shift from the realm of the political/legal to the economic/legal (producer/consumer).

In the UK, the Deregulation Initiative was to be the first of three important influences on the changing nature of risk in politics, all of which bore the imprint of Hayek's critique of social democracy. The second was a growing interest in the use of formal risk-assessment techniques in developing controls on chemicals and GMOs that culminated in the creation of the Inter-Departmental Liaison Group on Risk Assessment (ILGRA). The third influence lay in negotiations taking place at an international level between the EU and the Codex that proved pivotal in shaping reform of food safety in Europe and Ireland.

THE RECONFIGURATION OF RISK IN A NEW CONSERVATIVE ORDER

In both Europe and the US, the political landscape of the 1980s differed markedly to that of the 1960s and 1970s. The positive glow of post-war economic growth had subsided and was replaced with pessimism in political circles about escalating public-sector debt, increasing inflation and rising long-term unemployment. Under the leadership of Margaret Thatcher, Helmut Kohl and Ronald Reagan, conservative parties extolled the virtues of competition and individual responsibility. Under these leaders, consumers would benefit from greater choice and business would respond positively to the invigorating forces of the free market. Much of the intellectual resource for this new conservatism came from Friedrich Hayek's damning critique of socialism.

Hayek's antipathy toward socialism rests on the fact that two of its core principles, altruism and solidarity, provide the two greatest obstacles to sustained economic growth. Perturbed by the fact that even anti-socialists regard such concepts as virtuous, Hayek asserted that altruism can extend only to the needs of known other people and that in an extended order, its practice is impossible. In contrast to the interventionist vision of Keynes, Hayek proposed that the morality of the Great Society was one constructed upon individual freedom and responsibility, a limited state and a reduction in the power of the trade unions. Not surprisingly, the notion of social justice that pervades the Keynesian welfare state was viewed as pernicious, for not only does it deny the freedom of individuals (the state 'decides' what is fair, it defines what is just), but it undermines individual responsibility. In Hayek's view, liberty and responsibility were inseparable and a free society would not function or: 'maintain itself unless its members regard it as right that each individual occupy the position that results from his action and accept it as due to his own action'.21

Hayek produced an influential body of work that provided the bedrock for a conservative challenge to state intervention. From the 1980s onwards, conservative

21'Philips et al., Report of the inquiry, 43. 21See Friedrich Hayek, The constitution of liberty, (London, 1960), 72.




governments sought to redefine the relationship between the individual and the state, convinced that a retrenchment in the welfare state, a reduction in the power of trade unions and a programme of privatisation could release the invigorating forces of the entrepreneurial spirit.

Against this political backdrop, the first significant public arena in which the complicated role of risk in UK politics was seriously engaged was the public inquiry into the decision of the Central Electricity Generating Board (CEGB) to opt for the controversial Pressurised Water Reactor (PWR) for the Sizewell B nuclear plant (in Suffolk); this was a technology that had been used in the ill-fated meltdown at Three Mile Island in the US. Amid the turmoil that enveloped nuclear power in the post- Chernobyl period, much of the inquiry about the Sizewell B reactor was concerned with scientific uncertainty and the technological reliability of nuclear power. As the inquiry unfolded it revealed the propensity for major projects such as the Sizewell plant to be the subject of risk analysis. This type of analysis was an obscure area of science dominated by mathematical modelling that had assumed an increasing hold on policy-makers, discernible in the burgeoning field of research that sought to justify and expand its use.22 In a nutshell, risk forecasting does not guarantee that an event will not occur, only that it is unlikely to take place.23

In an attempt to grapple with some of the difficulties of risk analysis, the chairman of the Sizewell B inquiry, Sir Frank Layfield, criticised the concept of 'acceptable risk' because it failed to reflect the importance of the problem and, in particular, the level of reluctance individuals show toward involvement in hazardous activities.24 He suggested that the term 'tolerable risk' might better reflect the true seriousness of the question, prompting the UK's Health and Safety Executive (HSE) to argue that:

tolerability does not mean acceptability. It refers to the willingness to live with a risk to secure certain benefits and in the confidence that it is being properly controlled. To tolerate risk does not mean that we do not regard it as negligible or something we might ignore, but rather as something we need to keep under review.25

By the early 1990s the British government was pursuing the possibility of expanding the role for risk analysis as part of its drive to reduce public expenditure and redefine government responsibility. While a concern with public finances provided the initial spur for the British Treasury's involvement in exploring the utility of risk assessment

22See O'Riordan et al., Sizewell B. 23One of the criticisms of risk analysis is that implementation deficits, largely related to local factors,

are generally underestimated or downplayed because this type of analysis assumes a rational or methodical transfer (and acceptance) of knowledge. Moreover, there is little room for competing views, conflicts of opinion or differences about how change is received. In other words, risk analysis neglects the institutional context in which there may be: 'different definitions of the decision problems, different perceptions of what the primary risk-generating problem is, and different kinds of relevant experience and expertise'. See O'Riordan et al., Sizewell B, 14. A further problem lies in the use of comparison in fine-tuning, and with highly complex technologies, such as nuclear power or genetically modified organisms, where we have no experience to draw upon. This is an omission dramatically revealed at the Sizewell B inquiry, where the project director of the PWR at Three Mile Island was asked if he 'had any comparable experience?' His response, which provoked laughter in the audience, was 'No. (not) until after the accident', O'Riordan et al., Sizewell B, 182. For further criticisms of risk analysis see Mary Douglas 'Dominant rationality and risk perception', PERC Occasional Paper 4, (Sheffield, 1994). For those concerned with risk and nuclear power see Charles Perrow, Normal accidents (Princeton, 1999).

24See Hood et al., 'Risk management', 93. 25Hood et al., 'Risk management', 93.




in public policy, further momentum was given by a succession of White Papers that began to sketch out a shift in the role of risk in politics that would bear fruition in the Deregulation Initiative.

Under the arrangements envisaged in the Deregulation Initiative, a central task force of officials would check existing or new regulations initiated by a department or agency for their likely cost and impact upon business. From here on in, busy staff would be required to spend time identifying legislation that could either be revoked or simplified. The initiative also questioned the need for complex regulations that impacted on business, prompting the establishment in April 1991 of an official group to produce guidance on risk assessment, with a view to achieving greater consistency.

Such developments were not confined to the UK. From the early 1980s onwards the impact of federal regulation had become an increasingly controversial issue in American politics. Conservative lobby groups (such as the National Rifle Association) balked at the level of regulation to materialise from a sustained period of environmental legislation in the 1970s.26 Much of this legislation, and subsequent regulatory action, drew upon emerging scientific disciplines-toxicology, epidemiology and environmental monitoring-that raised new issues for administrative conduct: the relevance and integrity of the science, the competence of those charged with evaluating such evidence and the role of the courts in overseeing the way in which regulatory agencies operated.27

In the period that has elapsed since, the role and function of science in federal regulation has been increasingly the focus of challenge through the courts. Initially, the issue of judicial responsibility emerged in a series of debates that offered competing views on the appropriate judicial role. To some, it seemed sufficient that judges insist that scientific evidence was 'ventilated' with interested parties.28 However, to others it seemed that more should be expected of the courts, that judges should be versed in the underlying science in order to be able to assess an agency's competence. Although the courts of appeals assumed a 'hard look' position with regard to evidence submitted by regulatory agencies, they were generally disposed to a deferential position on expert advice submitted.29

This was a position that was eroded steadily as a series of high-profile cases sought to challenge the claim by regulatory agencies that their decisions were based on 'sound science'. Indeed, the findings of Daubert v Merrell Dow Pharmaceuticals Inc., were to signal a sustained assault on the role of science in regulatory decision- making. In what became a landmark case, the Supreme Court assigned a 'gate- keeper' role to federal judges hearing cases that involved expert testimony. Following Daubert, trial judges would be required to familiarise themselves with the science underpinning testimony, to assess whether it was sufficiently sound and whether the scientific data were sufficiently robust to justify the expert's scientific conclusions.30

26The most notable among a raft of new legislative reforms were the Clean Air Act (1963), the Occupational Safety and Health Act (1970), the Clean Water Act (1972), amendments to the Federal Pesticide Law (1972), the Toxic Substances Control Act (1976) and the Resource Conservation and Recovery Act (1976). The EU's convoluted attempts to legislate on the chemical industry have clearly been influenced by these developments.

27Richard Merrill, 'Foreword', Law and Contemporary Problems 66 (4) (2003), 1-5. 28Merrill, 'Foreword'. 29Merrill, 'Foreword'. 30Alan Raul and Julia Dwyer, 'Regulatory Daubert: a proposal to enhance judicial review of agency

by incorporating Daubert principles into administrative law', Law and Contemporary Problems 66 (4) (2003), 7-44.




In a conservative political environment in which the calls for the shackles on business to be removed were incessant, two other reforms complemented Daubert: the Shelby Amendment (1998) and the Data Quality Act (2000) (DQA).

To supporters of reform, the regulation of the 1970s and 1980s had either been based on 'bad science' or had resulted from a predefined agenda that chose to ignore competing scientific interpretations. For those who supported the 'good science' reforms, the intention was to improve peer review and provide checks on research of poor quality.3' Thus, the Shelby Amendment allows regulatory participants access to data underlying studies funded by federal money. Similarly, the DQA requires agencies to establish a process whereby parties can lodge petitions for the correction of information, and it places interested parties in the role of peer reviewer.

However, for those such as Wagner, the 'good science' reforms seem all the more incredible when the evidence for the use of unreliable science in over 30 years of environmental legislation remains extremely limited.32 Proponents of the Daubert reforms also tend to ignore the range of committees within the federal agencies designed to provide peer review and oversight and the fact that the scientific community itself provides a powerful check upon path-breaking claims.33 Moreover, attempts to 'Daubertise' often ignore the fact that most of the federal agencies engage in very little original science and fails to realise that most of the regulation was passed with the explicit purpose of by-passing heavy burdens of proof, largely because in areas such as toxic regulations this precautionary approach often makes rational economic sense.34

More disconcerting, perhaps, is the subtle effect these reforms have upon the burden of producing and then defending evidence. As Wagner points out, over the last 30 years scientific knowledge regarding public health and environmental harm has advanced very little. And yet, the 'good science' reforms focus on the few studies that have been done. Rather than increasing our knowledge base, the likelihood is that resources will be diverted to debating the quality of these studies.35 Moreover, these reforms have concentrated the focus on the quality of individual studies as opposed to on the weight-of-evidence arguments that often underpin regulation, challenging the risk assessments and the methodology of epidemiological studies that underpin health and environmental regulation.36

31Wendy Wagner, 'The "bad science" fiction: reclaiming the debate over the role of science in public health and environmental regulation', Law and Contemporary Problems 66 (4) (2003), 63-133.

32Wagner, 'The "bad science" fiction', 72-9. 33Wagner, 'The "bad science" fiction', 80-4. 34The good science reforms may also have the unintended consequence of undermining the quality

and quantity of agency science. Agencies may avoid disseminating data or may produce data that may be 'deconstructed'. Any risk assessments relying on 'cutting edge' data may be challenged through the Data Quality Act or regulatory Daubert. Scientists may also be reluctant to share cutting-edge work for fear that their work may be tarnished by good science complaints for more detail. As a consequence of these reforms, Wagner believes that agencies may prefer to make regulation on as thin a scientific record as possible, or may down play 'influential studies' so as to avoid the burden of 'reproducibility' under the Data Quality Act. See Wagner, 'The "bad science" fiction', 87-106.

35The private sector has little incentive to engage in research that may lead to further, more stringent regulation. The DQA also exempts industry from the good science requirements, a situation compounded by the protections available through trade-secret law and confidential business protection. See Wagner, 'The "bad science" fiction', 93-9.

36Epidemiology is a fledgling science that consists of a statistical comparison of human beings who have received a higher-than-normal exposure to a particular agent with others who have received little or none. The statistical threshold level is determined by the scientist and rests on the scientist's acceptance of what is a cause-effect relationship. And yet, as McGarity observes, the health and environmental risks posed by toxins and carcinogens cannot be proven with the certainty of




Taken together, the 'good science reforms' in the US do not simply qualify the actions of federal agencies but seek to redefine the role of science and risk in regulation. Under political administrations that favour deregulation, agencies are under direction to ensure that their science is not only of high quality, but also of sufficient magnitude or quantity, to justify regulation. Under such legislation, a range of business groups and trade associations have sought to limit regulation based on what they perceive to be 'junk science'.37 Such reforms have proved particularly influential in the arenas of European food and environmental regulation where the role of science has been reconfigured: new technologies such as GMOs may be contentious, they may well be risky, but grounds for regulation must be founded upon a proven risk.

If the challenge to federal regulation in the US resembled the desire in the UK to reduce the regulatory burden on industry, there was also enthusiasm to extend the role of risk assessment to a broader swathe of public policy, including controls on chemicals and GMOs. In the UK this culminated in the formation of the Inter- Departmental Liaison Group on Risk Assessment (ILGRA). Although initially it was far from systematic or fully coordinated, the civil service in the UK organised a series of seminars to draw upon expert advice from outside Whitehall to deliberate on the problems of adopting risk assessment.38

One of the more prominent issues addressed in this period was the role of risk perception, or perhaps more accurately a concern with the disparity between risk assessment and the public perception of that risk. Whereas scientists tend to compare and rank different risks according to probabilities, the lay public tends to be more subjective, taking account of the novelty of risks, the extent to which exposure to these risks was within public control and whether the hazards were man-made or natural.39 However, in line with developments taking place in Codex, the Irish and British governments shifted concern from 'risk perception' to 'risk communication'.40 The change in terminology (from risk 'perception' to 'communication') is instructive, for it reveals a subtle, but nonetheless important, reconfiguration of risk in politics. Terms such as 'risk perception' convey a concern with how the message is received, and if it is at variance with expert advice there is the potential for a crisis of credibility to emerge.41 However, under a regime in which risk communication is to the fore, there is less emphasis upon assuaging the public because the focus is on providing information upon which individuals will make judgements.

The third crucial influence was the negotiations that had taken place between European nation states, the Food and Agriculture Organisation (FAO), the World Health Organisation (WHO) and the Codex. Under the Sanitary and Phytosanitary

mathematical reasoning. The 'proof' generated is subject to conflicting interpretations-'there is no perfect epidemiological study'. Such studies often rely upon 'coherence or biological plausibility' as a criterion for the study's conclusion: in other words, does the evidence generated fit the 'known facts' from previous studies? As such, most agencies use epidemiological evidence not to provide absolute proof, but to assist in weighing evidence to reach an informed opinion. Because hazard identification is laden with uncertainty, there can be no definitive proof. Indeed, 'if definitive proof is the goal risk assessment is simply the wrong tool', Thomas McGarity, 'On the prospect of Daubertizing judicial review of risk assessment', Law and Contemporary Problems 66 (4) (2003), 165-7.

37McGarity, 'On the prospect', 167. 38Taylor, 'Risk and British politics'. 39See Hood et al., 'Risk management'. 4"For more detail see Taylor 'From the slurry to the curry'. 41Majone, 'The credibility crisis'.




Measures Agreement (SPS), Codex attempted to develop further its international reference status on food standards, a position that ultimately requires scientific justification for any new control measures that might diverge from internationally agreed, relevant standards. In tandem with the agreement on Technical Barriers to Trade (TBT), the SPS was designed to prevent technical legislation being adopted that may create unjustified barriers to international trade. Thus, while the SPS agreement acknowledges the sovereign right of states to provide the level of regulatory protection deemed appropriate, these measures must recognise the need to avoid constructing impediments to free trade.42

Under the WTO agreement on SPS, Codex is specified as the arbiter of scientific analyses of risk and can determine whether barriers to trade based on health concerns are justified.43 At the heart of this struggle to balance regulation and trade was an attempt to establish (market) consistency in the application of scientific standards. Concern was expressed not simply about the different terminology being used, but also about whether risk assessment should necessarily involve its management. Codex was looking to separate risk assessment from risk management, preventing nation-states from invoking regulatory principles that were not 'soundly' based on science and which would impair free trade. It was not just the potential for variations to emerge that alarmed multinationals, but the manner in which regulatory principles, such as the principle of precaution, could be invoked.44 Consistency was important, and the multinationals were keen that any new food safety authorities at the European or national level would be responsible for advising the level of scientific uncertainty that warranted the application of the precautionary principle.

Science, influenced by a conservative view of individual responsibility and a liberal distaste for state regulation of the market, is now charged with performing the crucial task of sustaining the view that 'risks' are an inescapable part of life. Its role is not to prevent development on the grounds that it may be risky, but to provide evidence that a product or technology will be detrimental to public health, thereby establishing negligence or culpability. In other words, if no risk can be proven, there is no risk.

42Taylor 'From the slurry to the curry'. 43See James, Kempler and Pascal, A European public health and food authority. 44While competing definitions of risk exist, the debate between the principle of precaution (PP) and

proportional regulation had been completed in favour of the latter. For many, PP appeared to offer regulation capable of reconciling the trade off between economy/environment. See Joyce Tait and Les Levidov, 'Proactive and reactive approaches to risk regulation: the case of biotechnology', Futures 24 (3) (April 1992), 219-23. However, it has become clear that the principle of precaution has been misunderstood. The literal translation of the German word Vorsorge is precaution or foresight but, whereas in English it often suggests something that goes beyond normal caution, in the German usage it includes a notion of good husbandry, what one might call best practice. In the area of air pollution for example, German control legislation was understood as a means of measuring 'control of emissions in accordance with the state of technology'. Public declarations may have exhorted the importance of reducing risk, but this often meant only ensuring that the level of risk was 'as low as possible'. And for those that state blithely that had the principle been adopted the BSE crisis could have been avoided, it is worth asking this simple question: at what point do you invoke the principle of precaution? This is a difficult enough question to answer at any time, but when faced with the pressure to reduce 'excessive regulation', to challenge influential political bodies such as the Irish Farmers Association and the British National Farmers Union or to threaten important export markets, it is a particularly thorny one to grasp. See K. Von Molke, 'The Vorsorgeprinzip in West German environmental policy', Royal Commission on Environmental Pollution: The best practicable option, Cm. 310. (1988).



TAYLOR-Risk, Science and Environmental Regulation in Ireland Ill

WATSON V THE EPA AND MONSANTO

If the intrinsic balance of nature is capable of instilling respect not to say awe in a relatively untutored mind such as my own, it is small wonder that persons of elevated sensibility...express deep misgivings at what they perceive as experimental tampering at the heart of this delicate balance.45

As a member of Genetic Concern, an unincorporated association, Clare Watson sought judicial review in 1998 of the decision by the Environmental Protection Agency (EPA) to grant experimental trials to Monsanto for its genetically-modified sugar beet plant. (Watson v EPA and Monsanto Plc, 1998, hereafter Watson v EPA).46 The thrust of Watson's case was that in issuing consents for trials to Monsanto, the EPA had failed to apply the 'effectively zero' test, a standard she maintained existed in the Genetically Modified Organisms Regulations (1994). Indeed, her counsel suggested that the declaration by the EPA that the risk from GMOs was 'extremely low' confirmed it had applied the wrong standard and had failed to eliminate risk to the environment. The EPA and Monsanto countered that the standard required was not that high, or indeed absolute. Although 'they did not state precisely' what the standard should be, they noted that the type of deliberate release of GMOs intended would be the basis for a decision.47

In the view of the presiding judge, Justice O'Sullivan, Watson was not only 'taking on a heavy onus of proof' but would need to recognise that 'the battle ground' had moved from the merits of scientific debate 'to the legal technicalities governing the processing of Monsanto's application for consent'.48 While he conceded that a considerable amount of opinion evidence had been submitted, he was adamant that the merits of the debate were irrelevant to the determination of the legal issues before the court and that it was the 'function of the EPA to assess such material', not a High Court judge 'whose expertise is in the field of law'. The principal concern for the court was to establish the 'standard' by which consents should be granted and whether the regulations were consistent.

As O'Sullivan acknowledged, his decision rested on an interpretation of three separate, but complementary pieces of legislation: the European directive on 'Deliberate release into the environment of genetically modified organisms' (90/220/EEC), the Irish government's 'Regulations on genetically modified organisms (1994)' (S.I. No. 345/1994) and the Irish Environmental Protection Act (1992). For the purposes of this paper two distinct, but related themes emerge from O'Sullivan's ruling. First, the extent to which environmental protection is deemed to be (only) one of a series of competing values (the others being competition and economic growth) to which the legislation seeks to define a balance.49 Second, that

45Justice O'Sullivan, Watson v EPA Monsanto, written High Court statements, Dublin, 6 October 1998, 1-58. (Hereafter cited as Watson v EPA.)

46Monsanto (and Novartis) had been engaged in developing a sugar beet plant that would be tolerant of glyphostate, an ingredient of Monsanto's well-known herbicide, Round Up. Whereas Round Up was a financially successful weed killer it was non-selective, which meant that it killed both weeds and crops. Developing a sugar beet plant tolerant to Round Up would allow farmers to apply a glyphostate product while the beet was growing that would kill weeds without affecting the beet crop.

47See Watson v EPA, written High Court statements, Dublin, 6 October 1998. 480'Sullivan, Watson v EPA. 49The US has long been concerned that European legislation in the 1980s had veered toward

embracing the principle of precaution, that regulatory bodies would become overly cautious or that nation states would use spurious cultural arguments or junk science to develop trade barriers. For more detail see Marsha Echols, 'Food safety regulation in the European Union and the United States:




much of the legislative remit is concerned not with environmental protection (at any cost), but with environmental management. In this latter scenario, risk assessment and management are separated. Trials and experiments form part of a licensing system in which science is recognised to be incomplete, research is a valued social exercise and, while trials may be risky, unless a risk is proven, there is no risk.

For those not versed in European environmental legislation, much of the European directive on deliberate release appears to provide the protection sought by many environmentalists. For example, it states that a competent body, such as the Irish EPA, shall 'give its consent only after it has been satisfied that the release will be safe for human health and the environment' and that: 'before undertaking a deliberate release into the environment of a GMO, or the placing on the market of a product containing or consisting of GMOs, notification with the national competent authority is required'. Consent shall be granted only when that body is 'satisfied' that the release will be safe for human health.50

On closer inspection, it emerges that the principal objective of the European directive lies not exclusively in environmental protection, but rather in attempting to affect a balance with other, related concerns such as competition and economic growth. The general tenor of the directive is to qualify rather than strengthen the manner in which environmental protection is considered. This is confirmed in the adoption of the principle of the BATNEEC in the EPA Act (1992). Here, O'Sullivan observed that this

provides merely that a person in charge of any process or action involving a GMO shall use the best available technology not entailing excessive cost...and so on...rather than a higher (and quite possibly excessively costly) degree of technology which one would have thought necessary if the standard contemplated in the Act is that all risks to health and the environment should be reduced to effectively zero.5'

In other words, there is a crucial economic dimension to the debate about environmental protection, one not considered fully in Watson's challenge, that the risk should be effectively zero. The second difficulty faced in the challenge presented by Watson can be found in the confusion between risk assessment and risk management, or perhaps more accurately in the failure to recognise that these are not conflated managerial exercises. The separation of risk assessment and risk management has important ramifications, both for Watson's challenge and environmental regulation.

different cultures, different laws', Columbia Journal of European Law 14 (3) (1998), 525-43. It is worth noting that in an attempt to assuage the US its free market commitments, the European directive on deliberate release stipulates that when a product containing a GMO or combination of GMOs is placed on the market, and it has been authorised under the directive, an EU member state may not, on grounds relating to matters covered by this directive, prohibit, restrict or impede the deliberate release of the organism in that product on its territory, where the conditions set out in the consent are respected.

50 This extract from the directive was cited by O'Sullivan in his ruling on Watson v EPA, and he went on to cite the following from the directive: 'whereas measures...which have as their object the establishment and functioning of the internal market should, in as much as they concern health, safety, environmental and consumer protection, be based on a high level of protection throughout the community...and that whereas the protection of human health and the environment requires that due attention be given to controlling risks from the deliberately released GMOs...that Member States shall ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment', cited by O'Sullivan, in Watson v EPA. (Emphasis added.)

51O'Sullivan, Watson v EPA. (Emphasis added.)




Counsel for Watson submitted that the evaluation of risks posed is something that is necessary, so that the EPA can ensure that the risk of adverse effects is effectively zero. However, in Justice O'Sullivan's view the EPA could not be satisfied, unless it had first evaluated the risks.52 In this vein, he felt that the EPA must be permitted to exercise a degree of discretion and that even where a court must be satisfied beyond reasonable doubt, this does not mean that there must be proof beyond a shadow of a doubt.

Moreover, in article 5(2) of the European directive, which deals with notifications to the competent authority, it explicitly states that a notification shall include a 'statement evaluating the risks' posed by GMOs to human health and the environment. This assumes the possibility of risks and contemplates not an absolute elimination of these risks, but their control. In other words, there is no environment in which risks are completely eliminated, or ventures that do not carry risks. Rather, it considers a scenario in which risks are assessed and then managed. In this first step, an analysis of the potential risk is developed, recognising fully that there may well be some level of risk to human health and the environment. Even if the EPA were to identify these risks, its remit, indeed its operating rationale, is not to prevent development at all costs, but rather to balance environmental concerns with economic development.53 Here, the legislative framework is replete with clauses that avoid attempts to establish absolute standards (such as effectively zero) and which, in turn, emphasise the importance of the pragmatic: experiments and trials on an on-going basis.

Once a risk analysis is complete, it becomes not a matter of preventing development, but how that risk is managed. Indeed, the directive explicitly anticipates such a development when it stipulates that:

it is necessary to establish harmonized procedures and criteria for the case by case evaluation of the potential risks arising from the deliberate release of GMOs into the environment...the introduction of GMOs into the environment should be carried out according to the 'step by step' principle; this means that the containment of GMOs is reduced and the scale of release increased gradually,...no product containing, or consisting of, GMOs and intended for deliberate release shall be considered for placing on the market without it first having been subjected to satisfactory field testing at the research and development stage in ecosystems which could be affected by its use.54

On completion of the first stage-a risk analysis-concern shifts toward environmental management. The purpose of both the Irish Environmental Protection Act (1992) and the EU directive is therefore to control risks, to establish a high level of protection throughout the community and to ensure that a consent is given only for releases that are safe. This interpretation is consistent with the step-by-step principle that governs the application for field trials. This ensures that a wider release, which follows a narrow one, is permitted only if evaluation of the earlier step (in terms of the protection of human health and the environment) indicates that the next step can be taken. Clearly, as O'Sullivan points out, this phraseology

521n the 1994 regulations, article 30(2) requires a notification to include sufficient information to enable the EPA to 'evaluate the foreseeable risks...the deliberate release...may pose to human health or the environment...Equally, the agency itself is required to "evaluate the risks posed by the deliberate release", which would appear to be a pointless exercise if those risks were reduced to effectively zero'. (O'Sullivan, Watson v EPA).

53See Taylor, 'Conserving the Emerald Tiger'. 540'Sullivan, Watson v EPA. (Emphasis added.)




contemplates that an earlier step could indicate that the later one should not be taken, because the deliberate release involved has not proved 'safe'. Accordingly, when article 4(1) of the European directive refers to all appropriate measures taken to avoid adverse effects, the word 'avoid' has to be read in the context of as requiring a high level of protection throughout the community, as distinct from requiring such a level of risk elimination as would render pointless the step-by-step principle.

Taken together, the findings in the case between Watson and the EPA/Monsanto reveal the changes that have taken place in the role of risk in regulation over the last two decades. Indeed, if we return at this point to the question posed in the introduction (if no risk can be proven is there a risk?) the response is 'No'. Or rather, not before we've gone ahead with experimentation to provide evidence that a risk is proven.

CONCLUSION

That a tension now resides in the relationship between science, regulation and political decision-making is undeniable. This paper has argued that if we are to understand the manner in which risk has been reconfigured in politics we need to abandon simplistic accounts of the relationship between science and politics that abound and that, more often than not, argue that government is no longer capable of juggling issues that are at the cutting edge of complex science; that risk in politics is an exclusively recent phenomenon. Indeed, the paper maintains that the regulation of the market by the interventionist state always recognised the uncertain nature of scientific advice and the need to consult and negotiate with vested interests in order to assuage groups from taking a legal challenge.

The paper has also argued that, as in other areas of public policy, the role of risk in politics has been reconfigured as a result of a sustained challenge to the interventionist state. The new conservatives have vilified legislation such as the ban on smoking in public bars precisely because it impinges upon individual liberty. The argument runs that such legislation forms part of a deluge in state responsibility, justified largely on the grounds of 'junk science' or, if you prefer, science that cannot provide certainty with regard to causal explanation, which undermines the spirit of free enterprise.

Influenced by a conservative view of individual responsibility and a liberal distaste for state regulation of the market, science is now charged with performing the crucial task of sustaining the view that 'risks' are an attendant feature of day-to- day life, that what matters is how, as individuals, we make judgements about those risks. The role of science, in that conservative view, is not to prevent development on the grounds that it may be risky, rather it is to establish definitively whether a product will be detrimental to public health, thereby establishing negligence or culpability. It is at this point that we see how the reconfiguration of risk has impacted upon environmental regulation in Ireland, an issue that Watson's challenge to the EPA and Monsanto failed to address. The Irish EPA Act and Part B of the European directive outline the contours in which the EPA's action are circumscribed not exclusively by environmental considerations, since environmental protection is simply one among a range of valued social objectives. It is a vision with which Hayek would have approved, for the role of science should not be to prevent development on the grounds that it may be risky, but to articulate the extent to which individuals are exposed to risk, or to define more clearly where no risk can be proven.



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If No Risk Is Proven, Is There a Risk? Some Reflections on Risk, Science and Environmental...

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