treatments that were implemented. In contrast, other interventions that were once thought beneficial, such as bed rest after childbirth or a heart attack, were found not to be beneficial once uncertainties were reduced.

In this chapter the committee reviews the decision-making tools and techniques from a number of different areas of public health, focusing on how uncertainty is taken into account in decisions. In particular, these reviews are in response to two of the questions in the committee’s charge: “What are promising tools and techniques from other areas of decision making on public health policy? What are benefits and drawbacks to these approaches for decision makers at EPA and their partners?” The committee could not review all organizations that make public health decisions or all decision-making processes, so it focused on selected agencies and organizations that, as does EPA, assess benefits and risks to human health (and in some cases technological, economic, and other factors), identify uncertainties, and make regulatory or policy decisions on the basis of those analyses. The chapter begins with a general discussion of the decision-making processes at a number of government agencies and organizations. It then uses case studies to illustrate how different agencies and organizations have made difficult regulatory or policy decisions while accounting for uncertainties.


A number of U.S. agencies play important public health roles that involve weighing evidence and taking into account uncertainties in the making of a policy or regulatory decision that affects public health. Table 4-1 summarizes the processes and methods used by different public health agencies and organizations to evaluate the human health risks and benefits and other factors influencing the decisions, along with their inherent uncertainties. As can be seen in the table, many organizations have no formal guidance materials related to their decision-making processes, and many do not conduct formal uncertainty analyses.

Within the U.S. Food and Drug Administration (FDA), some divisions—such as the center responsible for overseeing drug approvals and postmarketing safety, the Center for Drug Evaluation and Review, and the center responsible for overseeing medical devices, the Center for Devices and Radiological Health—have published guidance material on risk assessments. Historically, however, neither center provides a thorough discussion of uncertainty analyses or of the communication of those uncertainties along with FDA decisions, although a recent report for FDA has highlighted the importance of communicating the uncertainties in the agency’s decisions and the data that underlie them (Fischhoff et al., 2011). The Occupational Safety and Health Administration (OSHA) and the Nuclear Regulatory

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