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Making the Relationship between Risk Assessment and Risk Management More Intimate P. Calow†,* and V. E. Forbes‡ †
Office of Research and Economic Development, University of Nebraska-Lincoln, Nebraska 68583-0857, United States School of Biological Sciences, University of Nebraska-Lincoln, Nebraska 68588-0118, United States responses that organisms have, and loss of individuals (even some species) may not matter in terms of the delivery of ecosystem services. Even more generally, uncertainties abound at all levels in risk assessments and, because of the complexities, judgments about how seriously they should be taken are often made by the risk assessors. Second, risk should be expressed in terms of entities that matter. This is because management decisions are often made in the context of trade-offs between the benefits (to human health and environment) of an intervention and the costs of restrictions. Expressing the benefits in terms of entities that matter (human lives, lifespan, morbidity, and ecosystem services) and that can be valued facilitates balancing gains with the costs and making transparent decisions about the form and extent of interventions. As noted above, where the risk is expressed in terms of end points that are not directly related to the entities that matter (such as molecular and cellular responses) judgments have to be made about how important they are and this is often carried out by the risk assessors. Third, the effects should be calibrated against the changes needed to bring them about. This follows because the costbenefit analysis is most effectively carried out by calibrating marginal changes in impacts against changes in the conceneeping a separation between risk assessment and risk trations/doses needed to achieve them through restrictions. Yet management is a common theme in environmental risk characterizations are often expressed in terms of thresholds regulatory affairs. Values should play no part in the science of of effect/no effect. This means that judgments have to be made assessment, and management decisions often have to be based as to whether exposures are sufficiently close to thresholds to on more than the science and the values of scientists. Yet a merit concern, and again this is often done by the risk assessors. couple of recent reports, from both the US (“Silver Book” 1) Finally, there is an understandable inclination for scientists to and EU (Opinion of the Scientific Committees of the European call for more work to reduce uncertainties in assessments. In Commission2) arenas, have drawn attention to shortcomings in regulatory risk assessment the challenge will be to develop a the risk assessment process that derive, in part at least, from way of deciding how much science is enoughenough, that is, maintaining a too sharp separation between the assessors and to reduce uncertainties in the risks of making the wrong the managers. Here we revisit the relationship between risk decision sufficiently for policymakers to act with confidence assessment and risk management with these developments as rather than to continuously call for more funds. Whether and background and argue for a closer relationship. Our focus will how much to invest in more research ought to depend on the be on the risks from chemicals in the environment but the uncertainties and the costs of mistakesthe bigger these are, principles will be more broadly applicable. the more should be invested. FOUR CHALLENGES MORE DIALOGUE There are at least four challenges that arise from the sharp It should be clear from these four challenges that when separation of risk assessment and risk management. scientists make decisions about what to measure in assessing First, it is not always obvious to the risk assessors and the risks, and how much more work is needed to address stakeholders that they serve that decisions taken on what end uncertainties, they often exercise value judgments. These points to use in risk assessments involve value judgments. Thus should be subjected to policy steer. On the other hand there deciding to express risk to human health in either lives or lifespan has implications for how important you take the aged; Received: June 18, 2013 and deciding to measure impacts on cells instead of whole organisms or ecosystems has implications for how precauAccepted: June 28, 2013 tionary you want to be because cells may not have the defense Published: July 12, 2013 ‡
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dx.doi.org/10.1021/es402705y | Environ. Sci. Technol. 2013, 47, 8095−8096
Environmental Science & Technology
Viewpoint
should be no policy bias in assessing adverse effects and the causes of them. For example, political and economic pressures inappropriately and incorrectly led the science advice away from the hypothesis that the disease could cross the species barrier in the “mad cow debacle” in Europe in the 1990s.3 There needs to be better dialogue between scientists and policymakers to make the science more policy relevant without allowing this to bias outputs and conclusions.4
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HOW FAR TO GO? The “Silver Book” 1 modifies the risk assessment framework to involve an exchange between risk assessors and risk managers upfront to identify the management options that have to be informed by the risk assessment. The European Opinion2 advocates a process in which risk assessment and socioeconomic analysis (fundamental to sound risk management) run in parallel with exchanges upfront and at appropriate points during the course of the work to ensure that the risk assessment focuses on relevant protection goals. Some regulatory committees involve all stakeholders throughout the entire assessment process. More dialogue is certainly needed but the challenges of making it effective when it crosses disciplines, and hence involves different terms and processes, should not be underestimated. We believe that the right balance is likely to depend on circumstances. The less straightforward the policy options, the less clear the protection goals and the more uncertainty, the more extended should be the dialogue between assessors and managers5 and the more effort should be invested in making the dialogue work. This is not to advocate the mixing of values into the evidence-based assessments. On the contrary, and somewhat paradoxically, we believe that transparent interaction between risk assessors and the other stakeholders at all stages in the assessment/management chain is likely to lead to less value judgments (especially from the assessors) entering the process unnoticed and hence to a more credible and effective outcome. Careful consideration therefore needs to be given to the institutional arrangements for achieving this in specific regulatory contexts.
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AUTHOR INFORMATION
Corresponding Author
*E-mail:
[email protected]. Notes
The authors declare the following competing financial interest(s): Calow was chairman of the working group that developed the EU Opinion.2
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REFERENCES
(1) NRC. Science and Decisions: Advancing Risk Assessment; Committee on Improving Risk Analysis; National Research Council, National Academy of Sciences: Washington, DC, 2009. (2) SCHER (Scientific Committee on Health and Environmental Risks), SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), SCCS (Scientific Committee on Consumer Safety). Making Risk Assessment More Relevant for Risk Management; European Commission: Brussels, 2013. (3) Jasanoff, S. Designs on Nature; Princeton University Press: Princeton and Oxford, 2005. (4) Calow, P.; Forbes, V. E. Ecological risk assessment should be value-relevant but not value-biased. Integr. Environ. Assess. Manage. 2010, 6, 784−785. (5) Pielke, R. A. The Honest Broker; Cambridge University Press: Cambridge, 2007. 8096
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