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Chapter 2

Results of initiatives undertaken during the last two years

1. ILGRA's work over the past two years has concentrated on four of the broad areas where the first report identified that greater coherence and consistency in Departmental approaches to assessing and managing risks should help dutyholders in fulfilling their duties, while making the Government's approach as a whole look more cohesive. These are:
   • the development of more consistent approaches and methodologies for assessing and managing risks;
   • improving the way Government communicates about risk;
   • initiating projects to enable Departments to share their knowledge, resources and research on risk issues; and
   • commissioning, financing and steering a number of interdepartmental research projects on topics of interest to more than one Department.
     
2. These initiatives and their outcomes are described below. In addition a summary of the initiatives and Departments' involvement in them is at Annex 1.

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The Development of More Consistent Approaches and Methodologies

1. The need for Departments to adopt consistent methodologies for the assessment and management of risk was highlighted in the first report. This, it was argued, was necessary because risks rarely apply to a single receptor (eg, the public, workers) even though the boundaries of responsibility between Departments often appear to assume that is the case. It is evident that this has caused difficulties, not least for duty holders who often perceive regulators as adopting different standards for the same hazards in contexts which are not all that dissimilar.
   
2. Since then BRU has undertaken a number of initiatives aimed at promoting greater convergence towards regulatory best practice. They have published guidance documents on better regulation including regulatory impact assessments for Departments to follow when proposing regulations.
   
3. However, all Departments agree that much more can and should be done. ILGRA's approach to the problem has been:
   
   • to examine whether it is possible to develop consistent methodologies and guidelines for risk assessment and risk management across all Departments. In that context there has been much debate within ILGRA in order to achieve consistency in terms of similar treatment of similar problems. It was generally agreed (for reasons already mentioned in para12) that it would be both unreasonable and undesirable to expect Departments to have identical arrangements in place; and
     
   • where approaches are found to be different, to provide Departments with a forum in which the alternative approaches can be fully described and explanations given as to why the alternative approaches properly reflect the differing needs for protection of individuals and society in different areas of regulation.
     
4. ILGRA was helped in this work by two sub-groups. Their purposes andfindings are described below.

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Sub-group on Risk Assessment and Toxicology

1. This sub-group, known as the Risk Assessment and Toxicology Steering Committee (RATSC), was set up in April 1996 to guide an initiative to review progress and, in the longer term, to develop and validate innovative approaches to toxicological risk assessment.
   
2. This area was chosen because:
   • there has been considerable technological progress in the field of toxicology, for example, new methods such as in vitro studies or comparisons with toxicity of substances with a similar chemical structure are now available;
   • the control of exposure to chemicals is of interest to a wide range of Departments since it impacts on the regulation of food safety, manufacturing processes in industry, the safety of medicines, products used at home and in the workplace, and environmental pollution.
     
3. RATSC is chaired by the Chief Scientist of the Ministry of Agriculture, Fisheries and Food (MAFF) and attended by representatives from all those Departments and Agencies involved in toxicological risk assessment. In line with the above its aims are:
   • to review current practice for managing risks to health from toxic substances, taking into account both UK and overseas experience;
   • to produce a longer term research strategy to develop and validate innovative approaches to generating better estimates of risk and improved assessment procedures; and
   • to press for new regulations to be risk based, founded on agreed standards and facilitated through multi-national collaboration in this research programme.
     
4. Considerable progress has been made. An exercise mapping current practices for toxicological risk assessment has been undertaken. Three workshops have been held aimed at identifying those research areas which will yield better estimates of risk and improved assessment procedures. The reports of these workshops are being published. Where possible international consortia will be brought together to fund the research priorities identified. The outcomes of the research will be used to promote agreement on improved risk assessment procedures for incorporation into international regulations

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Sub Group on the Setting of Safety Standards

1. This second sub-group of ILGRA is concerned with rather broader issues. Its members are drawn from Departments but also include academic and industry advisers. It is chaired by the Treasury. The main purpose of the sub-group is to take forward the recommendations (see box on page 12) made by the Group on the Setting of Safety Standards (SSAS) in a sister report to the one produced by ILGRA. The SSAS report was published in June 1996 and was also endorsed by Ministers.

   ain Recommendations of the SSAS report these were:

   • a fully rule-based approach to safety regulations, where all regulations are set according to universal formulae quantifying costs and benefits, would be unrealistic. Nonetheless common frameworks could and should be developed for all safety regulations, despite the wide differences in available data and in attitudes towards different kinds of risks. This would provide a common basis for policy judgement and standard setting.
     
   • Even though the objective of all regulation should be a considered balance of costs and benefits, in the case of safety regulation, this has sometimes to include taking into account important ethical constraints.
     
   • Although regulation is widely based on the best available scientific data, there is a need for greater consistency in the extent to which costs of risk reduction, and the examination of public values and preferences, are taken into account.
2. The sub-group has taken forward its investigation through a series of case studies looking critically at how Departments set safety standards, including how far they adhere to the broad guidelines advocated by BRU in their guidance. The first area chosen for examination was environmental regulation. A review of DETR's "Guide to Risk Assessment and Risk Management for Environmental Protection" was already planned, and it was agreed that this could provide a useful context for the case studies. Three areas were examined: genetically modified maize; municipal waste incinerators; and limits for concentrations of benzene in air.
   
3. The sub-group has found evidence to support and add weight to the earlier findings of the SSAS group. Three broad problem areas were identified in the environmental case studies, but clearly these are also of relevance to other areas of regulation.
   
   • The role Of expert groups
     The role of scientific advisers is well established in the regulatory process, largely through their position on Government advisory committees. However, there is evidence of a lack of transparency in how experts reach decisions about the levels of risk posed by particular hazards. The sub-group judged that thought could usefully be given to clarifying the terms of reference for such groups so as to make clear that their role is to assist decision makers and not to set standards as such. This would help to ensure and make apparent that other useful inputs, such as costs and benefits, are also taken into account in the formulation of policy. This was particularly important. Once an expert group's judgement on the balance of the scientific arguments is published, pressure may be created for Government to regulate, even if it is unjustified in cost-benefit terms.
     
   • Ensuring that standards adopted reflect the values of society at large
     Even when the above factors are taken into account, policy makers must give due weight topublic perception of risk. The public themselves hold a wide range of value judgements and there is scope for improving consultation to take these into account. Departments therefore need to develop ways of explaining the scientific and policy background to decisions to the public, and to establish how best to incorporate both expert judgements and society's preferences into the decision-making process.
     
   • Dealing with uncertainty. The group suggested that in assessing risks where there is considerable uncertainty a clear distinction should be made between processes that are deterministic (where the cause assures the outcome) and those which are stochastic (where the outcome depends on chance). Unfortunately, for environmental risks, it is often the case that though one can readily identify the deterministic factors that must be present before the risk from a hazard is realised, the presence of these factors does not automatically mean that the risk will be realised because whether this happens or not is stochastic in nature. By analogy, one must hold a lottery ticket (a deterministic condition) to be entered in the draw. But possession of a ticket cannot guarantee winning a prize because that is a stochastic phenomenon.
     
   • Thus in estimating the risk of cancer from exposure to a contaminant or pollutant, an assessment of the exposure is first made, analogous to the number of tickets in the draw. However, the development of cancer within those exposed will be random because several of the critical factors that decide whether a particular individual develops cancer or not are inherently stochastic in nature.
     
   • Failure to distinguish deterministic from stochastic processes can cause confusion when assessing and managing risks. Thus many risk factors for disease (diet, lifestyle, exposure) may be known in a deterministic manner, but these factors can only contribute to the likelihood of the disease because the occurrence of the disease is stochastic in nature.
     
   • The Group suggested that in the cases studied not enough importance may have been attached to the stochastic processes involved.
     
   • The Group also re-iterated the need to identify and assess all possible options for tackling a particular problem and their merits. As far as the latter was concerned, they considered that there may be a role for multi-attribute analysis in choosing between potential options.

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Enhancing the UK's Effectiveness in International Negotiations

1. Most regulations on health, safety and environmental standards these days emanate from Europe or international fora. Risk assessment increasingly features in many of these, largely as a result of the success of UK negotiators.
   
2. However, a research project undertaken for ILGRA showed that, as in domestic policy, the absence of a common policy framework for risk assessment and risk management may be impeding the UK's effectiveness in the negotiation of European and international standards. The research commissioned for ILGRA, which has now been completed, assessed whether such a framework would be both desirable and achievable in the context of international negotiations, and made recommendations for improvement
   
3. The review confirmed that there are indeed wide differences within the UK and the EU in social, institutional, technical and legal approaches to health and safety and environmental regulation, some of which are justified or sustainable, and others not.
   
4. This is not unexpected given that each policy field has its established approach, cleared with Ministers and pressed for in European negotiations. Even so, the criteria used to choose between policy options are often unclear or not made explicit. A further observation was that the absence of information on the cost or benefits of implementation of European Directives was an impediment to the evaluation of outcomes. Such information could usefully help to steer the development of priorities for regulatory policy.
   
5. The review concluded that there was plenty of evidence to suggest that the likely benefits of greater consistency between Departments would not only strengthen the UK's position in international negotiations but would also bring benefits in terms of more constructive debate within Government, better prioritisation and better communication. A number of recommendations were made, relating to:
   
   • progressing towards a common framework for making decisions on risk;
   • improving communications on negotiations at international level;
   • steering this work centrally;
   • the need for common terminology between Departments.
     
6. ILGRA will be debating with BRU how best to take forward these recommendations.

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Improving the Way the Government Communicates About Risk

1. Educating the public about risks from the food they eat, the air they breathe and the environment in which they live without causing a socio-political response is a major challenge. This has been brought to the forefront by controversies surrounding events such as salmonella in eggs, listeria in cheese, blood clots from taking contraceptives, and anthrax spores in the London Underground - to name but a few.
   
2. During the past eighteen months ILGRA has embarked upon an inter-departmental project to provide guidance to Departments by distilling available good practice to improve the way risk communication is used to:
   • promote an informed debate about risks;
   • produce a constructive interaction at all stages of the decision-making process;
   • improve mutual understanding of public and Government attitudes to policy making about health, safety and the environment;
   • influence human behaviour in a positive manner.
     
3. The main aim has been to derive a set of generic principles for Government risk communications using the extensive literature available, and to test them through the examination of Departmental case studies carefully chosen to cover a range of hazards and contexts. The results are available in a short, condensed guide for officials involved in communicating on risks, and a report on the results of the research including details of the case studies. As such the project should also help to recognise good practice as well as directing and encouraging it.
   
4. The case studies have provided a number of useful insights into the way Departments use communication to develop, achieve and disseminate policy objectives and respond to concerns about risks. There is ample evidence of good practice, particularly where risk communication has been acknowledged as a valid policy instrument. But there are also shortcomings, for example:
   
   • it is the exception rather than the rule that communication is treated as an integral part of risk management policy;
   • communication is too often seen as one-way information provision;
   • risk debates are often technical in nature, presenting a barrier to public inclusion. Moreover, ensuing communications often focus on risk reduction measures which are unsympathetic to public concerns, with the net result that they do not inspire confidence and trust;
   • in certain fields, the provision of independent advice via expert committees is widely distrusted as part of the system. This may be because some of them have a history of taking their decisions behind closed doors. Moves towards making decisions of committees more accessible, such as the publication on the Internet of agendas and papers, and the widening of representation to include interested parties such as consumer and environmental groups, are helping to redress the situation while making further networks accessible for improving communications; and
   • practice varies widely across and even within Departments.
     
5. Four generic principles for successful risk communication have now been developed to address these shortcomings. The principles and how to implement them are explained in the guidance document which provides the blueprint for Departments to benchmark their own practice, identify where they might make improvements and implement change to suit their own circumstances.

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Sharing Knowledge, Resources and the Results of Research on Risk Issues

1. We pointed out in the first report that facts and data on risks are a valuable resource. Though the fact that Departments used different information technology hardware and software was once a major problem, this is no longer the case due to the availability of operating systems designed to work on most makes and types of information systems. This development together with a number of initiatives by the Government for achieving better co-ordination between Departments, such as the provision of an Intranet, should help achieve the desired objective of better sharing of data amongst Departments.
   
2. Deliberations at ILGRA suggest that there will have to be changes in the culture of Departments before easy cross-accessing of databases between Departments becomes a reality. In the meantime, ILGRA has put considerable effort into stimulating the identification of common research needs and the dissemination of information on research findings with some notable successes. For example, MAFF has taken the lead in compiling a list of risk related departmental research projects of common interest so that the findings can be shared throughout Government. Despite some problems in collating the information, not least because the information was not readily available in a consistent format, this initiative is providing a useful overview of the research interests across Government. Departments have now agreed that there would be benefits in keeping the list up to date, but further resource is needed to collect and compile the information in an accurate and accessible format.
   
3. Other examples of good practice in collaboration do exist, such as the use of Concordats between Departments, Agencies and Research Councils. The Environment Agency and HSE, for example, have explored how they might work together more profitably on research and have (recently) agreed a Concordat. This sets out how they can work together to identify interests, facilitate interaction, influence Research Councils, and learn from HSE's experience of research management. Departments also take action to share information and take views on research strategies, for example, by offering representation on research groups.
   
4. Sharing data and information between Departments on issues other than research also helps individual Departments to keep up to date with current developments. The business of ILGRA, including its biannual meetings, has provided a valuable forum for sharing information and stimulating debate. Presentations to ILGRA, some of which have been opened to a wider audience, have covered a wide range of methodological issues across a range of disciplines. Getting the right balance between enhancing understanding and information overload is not always easy, and it can be difficult to reach the right people, but ILGRA is taking steps to improve its accessibility by summarising information and by providing contact points for those who want to know more. Making use of communications technology, such as the Internet and the Government Intranet, will help.

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Identifying, Commissioning, Financing and Steering Research Projects

1. ILGRA is well placed to identify research where there would be distinct advantages in inter-departmental collaboration, either because the project can only be undertaken if Departments are prepared to make available their expertise or the data they hold, or which would benefit from joint funding because a single Department or Agency might be reluctant to invest their limited resources in investigating a problem which spans several others.
   
2. Accordingly, a number of projects have been funded across a broad range of topics and disciplines. We have already mentioned the projects on international negotiations and the risk communication benchmark study. In addition ILGRA has initiated the following research projects:
   
   • ways of establishing monetary values for avoidance of fatalities through health and safety measures. This research project, jointly funded by HSE, Treasury, DETR and the Home Office, will help to improve Departments' cost benefit analyses of risk reduction measures. It will also provide further information on what influences people's willingness to pay for reducing risks. So far, it has shown the benefits of using focus groups to access public opinion on such issues. Emerging results indicate that people readily accept the idea that policy makers working with limited resources must make choices between alternative risk reduction measures. This has prompted further research into the public's attitude to the acceptability of cost-risk trade-offs, and how these trade-offs are managed and presented.
     
   • incorporating expert judgement into decision-making. As a first step, a small project looked at how decision makers in a range of contexts use expert judgement. Further research, commissioned by HSE on behalf of a number of Departments, will analyse current practice for eliciting expert scientific advice or judgement and incorporating it into policy. The aim is to develop some guiding principles for establishing good practice. Such principles will benefit from wider dissemination and discussion.
      
   • ways of ranking risks. This critical review of the methods used to compare and rank risks summarised current practice and suggested broad criteria for ranking risks and ways of progressing such procedures.