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HOW FEDERAL 'GUESSWORK' MISLEADS CONSUMERSFrom Consumers' Research Magazine, Vol 78 No. 1, January 1995Editorial Preface by Consumers' ResearchSuch actions have great practical impact on consumers, since they often involve banning or limitation of services and products, denying access of medications and technologies, and imposing burdens on firms and individuals-all affecting the availability, cost, and quality of things that we consume. Environmental, workplace, health, and safety measures of all types rest on such allegedly scientific findings. As we have frequentLy reported, the "science" behind many of these decisions isn't very scientific. Rather, all too often, it rests on assumptions and procedures that are Little more than guesswork, and in many cases reflect a mind-set geared to ever-more-intrusive reguLation. In some instances, supposedly scientific standards are ignored, or altered, to fit a preconceived conclusion. * Concerns about these matters are underscored by a new report on federal regulatory policy - Choices In Risk Assessment: The Role of Science Policy in the Environmental Risk Management Process-sponsored by the U.S. Department of Energy. Despite the dry-sounding titLe, and under-stated official prose, this is an explosive document. What it tells us is that the federal regulatory process not only substitutes assumptions and "science policy" for knowledge, but that these assumptions are so heavily tilted toward banning things as to defy common logic. Among these assumptions are: 1) that any substance causing tumours in laboratory rats, administered in the most massive doses, must be carcinogenic for human beings; and 2) that there is no "threshold" for such dangers, so that even the tiniest quantities must be forbidden. Other factors enter in, but these two notions by themselves are enough to ban almost any substance on which the regulators set their sights. Interestingly, as this new report makes clear, these impossible standards have been waived when the regulators decide that they would like to do so (see box, page 12). Thus the standards are invoked to ban some things, but not others. Everything therefore depends on the discretion of the regulators, and/or political-ideological pressures in favour of banning something or letting it stay on the market. Whatever else this may be called, it doesn't sound very much like "science. " The reality of this process, and the degree to which assumptions and "science policy" are used in place of science, are seldom reported to the public. The result is not only to substitute guesswork for data, but also to mislead consumers as to what has been occurring. The following excerpts from the new report highlight these aspects of the subject. - Ed.
In the context of this report, "science policy issues" are the gaps and uncertainties in scientific knowledge and data that arise in the assessment of risks to human health and the environment associated with exposure to "substances, conditions, activities, and sites. Science policy decisions" are the policy choices made to bridge such gaps and uncertainties. Science policy decisions are vital to the regulatory risk assessment and management processes. Science policy decisions enable regulators to justify the costs of regulatory programs in terms of estimated health and environmental risk reductions.
Default assumptions are science policy decisions that are applied automatically when certain
science policy issues arise. Examples of science policy issues and the corresponding default
assumptions include:
Some risks to human health and the environment are provable. Provable risks can be measured or observed directly and include actuarial risks such as those associated with highway or air travel accidents. In contrast, other risks-such as those associated with low-doses of radiation or exposure to chemicals in the environment-are often too small to be measured or observed directly with existing scientific methods and available resources. Additionally, specific health and environmental effects are often difficult to attribute to specific causes because other competing causes cannot be excluded with reasonable certainty. Such risks are unprovable. However, the fact that a risk is unprovable does not mean that it does not exist. Provable risks can be calculated, whereas unprovable risks can only be estimated through the risk assessment process. Although unprovable risks may be estimated and expressed in probabilistic terms, they are at best educated guesses and do not constitute knowledge or uncontroverted fact. In other words, the ability to produce a numerical estimate of an unprovable risk does not mean that the risk is proven. By design, many science policy decisions lead to risk assessment results that are more likely to overstate than to understate risks. In other words, compensation for the lack of knowledge in the risk assessment process is intended to be protective of public health. Risk assessment results are even less likely to underestimate risk when, as is generally the case, a series of conservative science policy decisions is involved. There is nothing wrong with such science policy decisions and risk assessments unless the nature and extent of the science policy decisions madf are not fully disclosed to policy makers, risk managers, the media, and the public. The numerical results of' risk assessments tend to be emphasized while discussions of the role of science policy in generating the risk assessment results tend to be de-emphasized. For example, given that many risks are unprovable, there is some probability that, in fact, they are zero. For unprovable risks, science policy decisions enable the estimation of non-zero risks. However, this fact rarely, if ever, is clearly presented in a risk assessment. The lack of disclosure causes risk assessment results to be communicated essentially as fact. Such communication is misleading.
Lack of full and fair disclosure of the role of science policy in risk assessment is not the fault of regulators alone. Media communication of risk information tends to omit discussions of science policy because such discussions: 1) do not fit into sound bites, 2) tend to detract from the sensationalism of the risk information, or 3) are not simple to communicate, and subtleties are lost. When risks can only be estimated, the benefits of regulatory programs to reduce those risks also can only be estimated, are not verifiable, and depend on science policy-based assumptions. Similarly, cost assessments often depend on assumptions, are uncertain, and cannot constitute uncontroverted fact. An important distinction between estimates of costs and benefits is in the certainty of their existence. Because it is not possible to prove with certainty the existence of unprovable risks, the existence of benefits from regulatory programs also cannot be proven. In contrast, while there is uncertainty involved in cost assessments, such uncertainty is associated with the magnitude of the estimated costs, not their existence. Although a great deal of scientific knowledge has been developed over the last 20 years, existing knowledge still cannot answer all the questions we can put to it. Advances in knowledge are not likely to come fast enough to address the onslaught of genuine and manufactured, known and hypothetical, and significant and insignificant risks faced by regulatory agencies, the regulated community, and the public. Although continued scientific research is highly valued, from a practical point of view, regulatory agencies rarely enjoy the luxury of time to wait for new research to aid them in regulatory decisions. Hence, science policy decisions will continue to be relied upon by regulators. For policy makers and risk managers who are aware of the tendency of risk assessors to make conservative science policy decisions, regulatory decisions are easier, because they know their decisions are not likely to be made on the basis of underestimated risk.
Although risk assessors are likely to be aware of science policy issues and decisions, the same cannot be said for policy makers, risk managers, the media, and the public. Risk assessors often fail to emphasize the existence and extent of science policy in risk assessment. Where the role of science policy is not explicitly explained, risk estimates may be erroneously communicated to policy makers, risk managers, the media, and the public as uncontroverted fact. Because these groups are unaware of the role of science policy, they often fail to inquire about its impact on risk assessment. Either failure may result in regulatory decisions that are made on an uninformed basis to an uninformed, misled, or unnecessarily alarmed public. Risk assessors should ensure that such miscommunication does not occur. Policy makers, risk managers, and the media should inquire about the existence and extent of science policy. Decisions based on risk assessment affect the health and safety of people, the condition of the environment, the operation of federal, state, and local governments, and the operation of industries and businesses. Remarkably, no formal training in risk assessment or risk management is required of the policy makers, risk managers, and risk assessors and their staffs who participate in the making of these weighty regulatory decisions. In contrast, physicians, attorneys, policemen, fire-fighters, plumbers, and electricians, among others, are required to undergo substantial training, apprenticeship, and licensing before engaging in their respective occupations. Although professional societies exist, and regulatory agencies sponsor seminars and workshops from time to time, there is no system in place which attempts to achieve a minimal level of competence in the area of risk assessment and risk management among all policy makers, risk managers, risk assessors, and their staffs. Because risk assessments for unprovable risks are educated guesses, risk assessment results should never intentionally or inadvertently be presented as fact. Full disclosure of the role of science policy should accompany risk estimates wherever presented, including Federal Register notices, executive summaries of regulatory documents, press releases, and other public and media communications. Disclosure is ineffective if it is inaccessible.
[It should be] comprehensive, explicit, and understandable. Disclosure should attempt to address
the following questions:
Answers to these questions will facilitate understanding of the likelihood that a risk exists and its potential magnitude. Improved understanding will enable: 1) policy makers and risk managers to decide on a more fully informed basis whether and what resources should be expended to address the risk and 2) the public and media to debate the issue on a more fully informed basis. Risk assessment guidelines can provide a framework within which regulators can make science policy decisions. Such a framework would provide the regulated community and the public with the "rules" for science policy decisions in regulatory risk assessment. Flexible guidelines would delineate the factors to be considered in developing a risk assessment and would require explanations for all judgments. Risk assessment guidelines should not establish a cookbook approach. Unless the guidelines are flexible enough to accommodate new scientific developments and specify the level of evidence required to deviate from a default assumption, efforts to develop new knowledge may be stymied or wasted. This could, in turn, inhibit advances in risk assessment. To the extent that risk assessment guidelines actually provide policy guidance, such guidance should be complied with in good faith by regulatory agency staff or it will be of little practical value. Default science policy decisions generally are employed in risk assessment. In some cases, however, regulatory agencies have opted to use alternatives to the default science policy decisions where this alternatives are supported by scientific knowledge or data. This trend should be encouraged To the extent possible, risk assessment guidelines should prove a timely and effective process for evaluating and implementing potential alternatives to the default science policy decisions. Such a process should include a compliance mechanism, perhaps independent from the particular regulatory agency, to ensure an objective review.
Risk assessment is a valuable tool through which regulators can gauge the existence and severity of potential risks to human health and the environment. Risk assessment cannot provide the definitive answers policy makers, regulators, the regulated community, and the public would like. Nonetheless, risk assessment based on science policy can frame the debate about whether particular potential risks should be regulated and who should bear t.he costs of regulation. Full and open disclosure of science policy in risk assessment can take the debate to the next level. Only when policy makers, risk managers, the public, and the media fully understand the role of science policy decisions in risk assessment can the "real" issue in environmental and public health protection be debated. We must determine what society is willing to pay to reduce or avoid risks to human heath and the environment which have been identified and estimated using science policy rather than science alone. These risks may or may not actually exist. If they do exist, they are likely to be relatively small or in.distinguishable from other risks. If risks are too small or indistinguishable, it likely will not be possible t i know whether regulation produced any benefit. The open debate of the value and priority of regulating these types of risks will enable, but not guarantee, policy and regulatory decisions to be made on a fully informed basis. Copyright © 1994 Regulatory Impact Analysis Project, Inc., Washington, D.C.
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