4

Uncertainty and Decision Making: Lessons from Other Public Health Contexts

The U.S. Environmental Protection Agency (EPA) is not the only agency or organization that must make decisions in the face of uncertainty. Other agencies do as well, and, as is the case with EPA, when making a decision those other agencies must consider the likelihood and magnitude of a risk, the number of people at risk, whether some people are more at risk than others, the likelihood that a given intervention will mitigate the risk, the cost of potential interventions, and the potential consequences of inaction.

A number of decisions about public health interventions that are now well understood were made at a point in time when there were more uncertainties. For example, it is now well accepted that the pasteurization of dairy products eliminates the risk of infections caused by Campylobacter jejuni, Salmonella species, and other pathogens (FDA, 2011a); that fortification of foods with vitamins and minerals decreases the health consequences of vitamin and mineral deficiencies, e.g., that the fortification of wheat products with folate decreases neural tube defects (Darnton-Hill and Nalubola, 2002); that vaccination against common childhood infections prevents serious morbidity and mortality (Bonanni, 1999); and that prenatal screening for HIV infection facilitates the immediate postdelivery administration of antiviral agents to prevent HIV infection in an infected baby (Anderson and Sansom, 2006). However, not all of those interventions were unanimously accepted when first proposed or implemented, primarily due to uncertainties surrounding the possible benefits, risks, costs, feasibility, and public values. Many of those uncertainties have been reduced through research, including research on the effects of the interventions or



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4 Uncertainty and Decision Making: Lessons from Other Public Health Contexts T he U.S. Environmental Protection Agency (EPA) is not the only agency or organization that must make decisions in the face of un- certainty. Other agencies do as well, and, as is the case with EPA, when making a decision those other agencies must consider the likelihood and magnitude of a risk, the number of people at risk, whether some people are more at risk than others, the likelihood that a given intervention will mitigate the risk, the cost of potential interventions, and the potential con- sequences of inaction. A number of decisions about public health interventions that are now well understood were made at a point in time when there were more un- certainties. For example, it is now well accepted that the pasteurization of dairy products eliminates the risk of infections caused by Campylobacter jejuni, Salmonella species, and other pathogens (FDA, 2011a); that forti- fication of foods with vitamins and minerals decreases the health conse- quences of vitamin and mineral deficiencies, e.g., that the fortification of wheat products with folate decreases neural tube defects (Darnton-Hill and Nalubola, 2002); that vaccination against common childhood infec- tions prevents serious morbidity and mortality (Bonanni, 1999); and that prenatal screening for HIV infection facilitates the immediate postdelivery administration of antiviral agents to prevent HIV infection in an infected baby (Anderson and Sansom, 2006). However, not all of those interventions were unanimously accepted when first proposed or implemented, primarily due to uncertainties surrounding the possible benefits, risks, costs, feasi- bility, and public values. Many of those uncertainties have been reduced through research, including research on the effects of the interventions or 107

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108 ENVIRONMENTAL DECISIONS IN THE FACE OF UNCERTAINTY 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 commit- tee 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 organiza- tions have made difficult regulatory or policy decisions while accounting for uncertainties. UNCERTAINTY AND PUBLIC HEALTH DECISIONS 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 un- certainties. 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 post­ marketing safety, the Center for Drug Evaluation and Review, and the center responsible for overseeing medical devices, the Center for Devices and ­ adiological Health—have published guidance material on risk assess- R ments. 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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UNCERTAINTY AND DECISION MAKING 109 TABLE 4-1 Assessment of Risks, Benefits, Other Decision-Making Factors, and Uncertainty at Selected Public Health Agencies and Organizations Agency/ Organization Method of Assessing Risks Uncertainty Analyses EPAa Conducts quantitative Conducts extensive quantitative assessments of risks. uncertainty analyses of the risks of The assessment method varies individual chemical or other agents. depending on the nature of The uncertainty analyses of human the exposure (for example, health risk estimates often includes inhalation exposure vs. the uncertainties in the ingestion) and the endpoint of concern (for example, cancer   •  dose–response assessment, vs. non-cancer endpoints).   •  exposure assessment,   •  toxicity assessment, and Has published extensive   •  risk characterization. number of detailed guidance documents and other materials Has conducted some assessments, related to its assessment including analysis of the uncertainty methods and assessments in estimates of benefits and costs. of risks, benefits, and other factors related to individual agents and regulatory decisions. Participated in interagency working group on risk assessment guidelines. FDA–CFSAN Conducts quantitative Uncertainty analyses vary among assessments of risks, including the assessments, with some having product-specific assessments, qualitative and some having pathogen- and chemical- quantitative assessments. specific assessments, product- Some analyses have estimated the pathway assessments, and effects of different regulatory actions risk-ranking assessments (for example, Listeria monocytogenes (for example, Listeria assessment in FDA, 2003). Food monocytogenes in ready-to-eat terrorism and vulnerability foods, and methylmercury in assessment guidance discusses the seafood). fact that uncertainty exists, but does not provide formal guidance for Published guidance for risk analysis of uncertainty. assessments for food terrorism (FDA, 2012a). continued

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110 ENVIRONMENTAL DECISIONS IN THE FACE OF UNCERTAINTY TABLE 4-1 Continued Agency/ Organization Method of Assessing Risks Uncertainty Analyses FDA–CDER Has published guidance for Discusses the fact that uncertainty industry on premarketing risk exists, but does not present any assessment (for example, FDA, formal guidance for analysis of 2005). uncertainty. Has published guidance on The guidance does not contain risk communication with the a specific discussion of the public in the context of drug communication of uncertainty. safety (FDA, 2012b). FDA–CDRH Has published guidance for Guidance discusses the sources of industry for benefit–risk uncertainty in the science supporting determinations (FDA, 2012c). estimates of human health risks and benefits. There is no guidance related to how to analyze uncertainties. CDC–ACIP Uses the GRADE system to The GRADE system includes review and classify evidence a discussion of the strengths (Ahmed et al., 2011). and limitations of the evidence. Depending on the information available, detailed uncertainty information, including uncertainty in the analysis of costs and benefits, is considered in ACIP’s recommendations. AHRQ–Evidence Categorizes the strength of the The categories used include a Based Practice evidence related to medical qualitative discussion of the Centers interventions using a process uncertainties in evidence. based on the GRADE system. OSHA Conducts quantitative Some assessments include some assessments of risk estimates quantitative analyses of uncertainties for different exposures (such as the presentation of upper (exposures might be, for and lower bounds on estimates example, individual chemical or the evaluation of the effect of exposures, noise exposure, or using different models to generate job descriptions). estimates). FSISa Conducts qualitative, semi- The uncertainty analysis varies quantitative, and quantitative among the assessments; some include assessments of human health qualitative analyses and some include risks (for example, the quantitative analyses, sometimes Listeria monocytogenes risk including analyses of the effects assessment in FDA, 2003). of different regulatory actions (for example, the Listeria monocytogenes risk assessment in FDA, 2003).

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UNCERTAINTY AND DECISION MAKING 111 TABLE 4-1 Continued Agency/ Organization Method of Assessing Risks Uncertainty Analyses Nuclear Regulatory Conducts quantitative, Conducts uncertainty and sensitivity Commission probabilistic risk assessments analyses in its assessments. to estimate the likelihood and consequences of different events to help develop “risk- informed, performance-based regulations” (NRC, 2012). WHO–IARC Publishes IARC Monographs, Monographs include a qualitative which evaluate the increased discussion of the uncertainties in the risk of cancer associated evidence and identify data gaps. with environmental factors (including chemicals, complex mixtures, occupational exposures, physical agents, biological agents, and lifestyle factors). The monographs include a qualitative assessment to classify environmental factors into groups on the basis of the evidence of carcinogenicity. WHO–FAO Has published detailed Detailed discussions of the guidance and assessments for uncertainties in estimates of microbial risk characterization health risks and analyses of those in food that include uncertainties. Some assessments qualitative, semiquantitative, discuss economic factors in decisions, and quantitative human including uncertainties in economic health risk assessments. analyses. Some assessments include Has published quantitative discussion of risk communication. assessments of the health Uncertainties are discussed, but risks associated with various no quantitative assessments of chemicals in food (WHO, uncertainties. 2013). NOTES: ACIP, Advisory Committee on Immunization Priorities; AHRQ, Agency for Health- care Research and Quality; CDC, Centers for Disease Control and Prevention; CDER, Cen- ter for Drug Evaluation and Review; CDRH, Center for Devices and Radiological Health; CFSAN, Center for Food Safety and Nutrition; EPA, Environmental Protection Agency; FAO, Food and Agriculture Organization of the United Nations; FDA, Food and Drug Administra- tion; FSIS, Food Safety and Inspection Service; GRADE, Grading of Recommendations As- sessment, Development and Evaluation; IARC, International Agency for Research on Cancer; OSHA, Occupational Safety and Health Administration; WHO, World Health Organization. aEPA and FSIS, in conjunction with other public partners published microbial risk assess- ment guidelines (USDA/FSIS and EPA, 2012). The guidelines discuss uncertainty, uncertainty analysis, and how to communicate uncertainty for risk characterization.

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112 ENVIRONMENTAL DECISIONS IN THE FACE OF UNCERTAINTY Commission discuss and use uncertainty analyses when formulating regula- tions, as does the Agency for Toxic Substances and Disease Registry of the U.S. Centers for Disease Control and Prevention (CDC) when it conducts its health assessments. At the international level, the International Agency for Research on Cancer of the World Health Organization (WHO) evaluates the evidence for the carcinogenicity of different agents and classifies those agents into different categories according to their estimated carcinogenic- ity; uncertainties are presented qualitatively when discussing the gaps in evidence. Both the Food Safety and Inspection Service (FSIS) and the Center for Food Safety and Nutrition (CFSAN) at FDA have published—individually and jointly—a number of assessments of the health risks associated with chemical or biological agents in different foods. Those assessments often contain quantitative analyses of uncertainties and sensitivity analyses. In addition, an interagency working group1 has published draft guidelines for microbial risk assessments for food and water. The guidelines discuss the analysis and communication of uncertainties in risk assessments. WHO and the Food and Agriculture Organization (FAO) of the United Nations have also published guidance for the characterization of the risks from microbial contamination of food. That guidance discusses qualitative and quantitative human health risk assessments and the analyses of uncertainties in those as- sessments. They also discuss economic analyses to support decision making and the concomitant uncertainties in those analyses. Other uncertainties are not discussed, nor are issues related to the communication of uncertainties in the assessments of health risks and economics. The U.S. Preventive Services Task Force (USPSTF), an independent task force that is supported and administered by the Agency for Health- care Research and Quality, uses an evidence-based approach to evaluate health care interventions and make recommendations for clinical practices, including medical screening tests. To do so, the USPSTF uses an adapted version of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system that qualitatively characterizes as high, moderate, or low the likelihood that a practice or treatment is beneficial. A working group designed the GRADE system as “a common, sensible and transparent approach to grading quality of evidence and strength of recommendations” (GRADE Working Group, 2012b). A number of dif- ferent organizations, such as the USPSTF and CDC’s Advisory Committee on Immunization Practices, have used the GRADE system to characterize evidence and recommendations (GRADE Working Group, 2012a). The use of GRADE when making recommendations related to vaccines is briefly discussed later in this chapter. 1  The working group included representatives from FDA, FSIS, and EPA.

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UNCERTAINTY AND DECISION MAKING 113 The organizations that use more sophisticated uncertainty analysis, such as the Nuclear Regulatory Commission, FSIS, CFSAN, OSHA, and FAO, do so using methods and approaches that are similar to those used by EPA. A few organizations discuss the presence of uncertainty in eco- nomic analyses, but even those organizations do not explicitly discuss how or whether that uncertainty affected their decisions. Furthermore, they rarely consider factors other than health risks, health benefits, and economic analyses in their decision-making process. Many of the organiza- tions elicit input from stakeholders through public meetings and comments on proposed action, much as EPA does; they do not, however, set forth an explicit process for incorporating uncertainties, such as a heterogeneity of stakeholder perspectives, into decision making. In reviewing the processes of these public health agencies and orga- nizations, the committee identified a number of assessments or decisions that illustrate the techniques and approaches that have helped—or, in one instance, handicapped—decision makers in their efforts to make decisions in the face of uncertainty. These cases include the following, which are discussed below: (1) the assessment of the health effects associated with secondhand smoke; (2) FSIS and FDA’s assessment of regulations related to Listeria monocytogenes; (3) FSIS’s assessment of the human health risks associated with bovine spongiform encephalopathy; (4) FSIS’s and FDA’s decisions surrounding the contamination of the food supply with melamine; (5) FDA’s decisions related to the diabetes medication Avandia® (rosigli- tazone); and (6) assessments related to vaccinations. The committee did not attempt to develop a thorough evaluation or critique of each case; rather, it focused on aspects of the different cases that demonstrate useful approaches to evaluating and considering uncertainty in regulatory or policy decisions.2 SECONDHAND SMOKE Smoking bans that limit exposures to secondhand smoke (SHS) have been enacted in many places despite some stakeholders pointing to uncer- tainties in economic and other data as well as to uncertainties in estimates of health risks as a reason not to enact bans. Those uncertainties are thought to have been generated or at least exaggerated by the tobacco industry (Muggli et al., 2003; Ong and Glantz, 2000; Tong and Glantz, 2007). This section discusses what evidence was available on the economic 2  Thecommittee uses these cases to illustrate the types of analyses and processes conducted in public health settings that can facilitate decision making. The committee is not endorsing, commenting on, or drawing any conclusions about the appropriateness or correctness of the regulatory or policy decisions themselves.

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114 ENVIRONMENTAL DECISIONS IN THE FACE OF UNCERTAINTY impacts and public acceptance of smoking bans at the time of decisions and what lessons can be learned from the implementation of these bans. Human Health Risks Although many of the human health risks associated with cigarette smoking were well established by the 1960s (U.S. Surgeon General’s Advi- sory Committee on Smoking and Health, 1964), it was not until 1986 that a surgeon general’s report concluded that SHS increased the risk for many different adverse health outcomes (HHS, 1986). The evidence of the risks from SHS comes from environmental chemistry and toxicology, including animal models of disease, as well from as observational studies (most of which were case-control studies or meta-analyses of those case-control stud- ies). Federal and state human health risk assessments have concluded that SHS is harmful to humans (Cal EPA, 2005; EPA, 1992; NTP, 2011). Most of the risk-assessment findings were based on quantitative, well-conducted studies, although the findings were not always consistent among the stud- ies (see HHS et al. [2006] and IOM [2010a] for reviews of the studies). Concerns about variations in findings for a specific condition were allayed by the large number of studies, their general consistency, and the results of a number of meta-analyses conducted. Despite the scientific evidence indicating adverse effects of SHS— including EPA’s assessment of environmental tobacco smoke (EPA, 1992), some individuals and groups, many of whom had financial interests in not having smoking bans, called the evidence into question (Oreskes and Conway, 2010). Similarly, public comment periods on health risk assess- ments and proposed policies and regulations were often dominated by individuals or groups criticizing the studies who were often allied with the tobacco industry, and tobacco industry documents indicate that they had a strategy of maintaining the scientific debate around the health effects of secondhand smoke (Bryan-Jones and Bero, 2003). To set smoking policies, therefore, decision makers had to distinguish between true uncertainties in the evidence and unfounded criticisms of the evidence motivated by finan- cial interests, and they had to not only consider the results of each study, but also carefully scrutinize the quality of each study under consideration. Economic Factors One economic factor that was taken into account when considering smoking bans was the potential economic effects on the establishments that would be subject to the bans (for example, bars and restaurants). Be- fore the advent of state and local regulation, few studies had evaluated the

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UNCERTAINTY AND DECISION MAKING 115 economic effects that smoking restrictions and bans might have on those establishments. Because detailed studies of the economic consequences of likely regulations and policies were often unavailable, there was also no characterization of the uncertainties surrounding those economic factors. Legislatures were left to make decisions on environmental controls for SHS exposure in the face of large uncertainty and intense lobbying. As smoking bans were enacted and implemented, studies have looked at the economic consequences of the bans, for example, on restaurants and bars (Glantz and Charlesworth, 1999), which has decreased the uncertainty around the economic factors. Public Acceptance In accordance with national or local rules, decisions on smoking restric- tions and bans generally included the opportunity for the public to com- ment on the proposed policies and on the science underlying them (Bero et al., 2001). As mentioned above, many of the people commenting spoke out against the policies, but some of that opposition was orchestrated by the to- bacco industry and allied parties (Mangurian and Bero, 2000). In addition, several commentators on the process suggested that there was “burnout” by the public on SHS issues and a loss of advocacy that came with many years of direct cigarette regulation, particularly at the local level (WHO, 2006). Furthermore, the national environmental and public health organi- zations and agencies that could have supported local and state regulations often did not weigh in strongly, possibly because of a coordination (Bero et al., 2001). Those aspects increased the uncertainty about the percentage of people and which sectors of the public were for or against smoking bans and restrictions. Further problems with the interactions with stakeholders may have been caused by communication issues, including a lack of communication about the uncertainties surrounding the issue. Most communication with stakeholders about uncertainty used standard statistical presentations of epidemiological studies and meta-analyses (Hackshaw et al., 1997; Law et al., 1997), and there appears to have been little attempt in the federal (EPA, 1992; NTP, 2011) and state risk analyses (see, for example, Cal EPA [2005]) to present uncertainty in lay terms. The dose–response phenom- enon was also not discussed extensively, with the exception of questions concerning the relevance of studies of home exposures to social exposures. Those discussions could have led the public to believe that the extent and implications of uncertainties in the data and analyses were greater than they actually were.

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116 ENVIRONMENTAL DECISIONS IN THE FACE OF UNCERTAINTY Decisions in the Face of Uncertainty: Lessons Learned Given the lack of any known health benefits from exposure to SHS, health assessments centered on the risks associated with exposure to SHS. Despite a large amount of evidence related to those risks, discussions often focused on the uncertainties in the evidence rather than on its consistencies; individuals and groups with a financial stake in blocking smoking restric- tions and bans often drove those discussions (Bryan-Jones and Bero, 2003). There was large uncertainty about the potential costs from lost revenues to establishments subject to bans and about the financial benefits from avoided medical costs. The discussions of smoking bans also raised social issues related to infringing on personal, voluntary behaviors and personal rights, with a large amount of heterogeneity in people’s opinions on those issues. States and local jurisdictions where there was either the political will or higher public acceptance of bans were the first to implement smoking restrictions and bans. Researchers took advantage of some of those bans to investigate whether they were associated with any health effects, to study the public reaction to the bans, and to see whether the bans had any economic consequences on establishments covered by the bans. Epidemi- ology studies indicated that smoking bans or restrictions were associated with decreases in adverse cardiovascular events (Barone-Adesi et al., 2006; Bartecchi et al., 2006; Cesaroni et al., 2008; IOM, 2010a; Juster et al., 2007; Khuder et al., 2007; Lemstra et al., 2008; Pell et al., 2008; Sargent et al., 2004; Seo and Torabi, 2007; Vasselli et al., 2008). Research surveys showed that the public approval of various state and local laws and regula- tions was generally, although not uniformly, positive after implementation, both in the United States and other countries (Borland et al., 2006; Kelly et al., 2009; Miller et al., 2002; Pursell et al., 2007; Tang et al., 2003). For example, in 2000 73.2 percent of people surveyed in California who had visited a bar at least once in the previous year approved of California’s smoke-free laws, up from 59.8 percent in 1998, the year that a ban of smoking in all bars was implemented (odds ratio [OR] = 1.95; 95 percent confidence interval [CI] = 1.58, 2.40) (Tang et al., 2003). Studies of the economic effects of the bans on restaurants and other establishments de- creased the economic uncertainties related to smoking restriction and bans (Glantz and Smith, 1994, 1997; Hyland et al., 1999; Sciacca and Ratliff, 1998; Scollo et al., 2003). With the decreased uncertainty provided by all these types of studies, other state and local regulators had stronger evidence on which to base their decisions. As of October 5, 2012, more than 3,581 municipalities had laws that restrict where smoking is allowed, and “36 states, along with American Samoa, the Northern Mariana Islands, Puerto Rico, the U.S. Virgin Islands, and the District of Columbia” had workplace laws that restrict smoking (ANRF, 2012). U.S. efforts to characterize the

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UNCERTAINTY AND DECISION MAKING 117 risks of environmental tobacco smoke have also been used to support in- ternational smoking bans. The passing and implementation of smoking bans provides many les- sons for EPA and for other regulators. First, it emphasizes the importance of scientists and policy makers scrutinizing the quality of individual stud- ies as part of appropriately determining the overall weight of the evidence and the uncertainty in it. Second, it demonstrates the need to consider the sources of scientific criticisms and uncertainties that are raised and to sepa- rate valid scientific criticisms from invalid ones. Third, it emphasizes that when considering economic factors and other factors, such as public ac- ceptance, uncertainty based on anecdotal concerns about potential financial consequences might not reflect the actual effects of a regulation. Fourth, it illustrates the heterogeneity in public values and how acceptance of health- protective policies can shift over time, leading to new societal norms. LISTERIA MONOCYTOGENES Listeria monocytogenes is a bacterium that causes listeriosis, a poten- tially fatal bacterial infection that can result from eating food contaminated with the bacterium (FDA and FSIS, 2003a). Listeriosis primarily affects pregnant women, older adults, and persons with weakened immune systems (FDA and FISIS, 2003a). Infections during pregnancy can lead to premature delivery, infection of the newborn, or stillbirth. Death occurs in 20 percent of cases of listeriosis (Swaminathan and Gerner-Smidt, 2007); CDC esti- mates that L. monocytogenes causes nearly 1,600 illnesses each year in the United States, including more than 1,400 hospitalizations and 255 deaths (Scallan et al., 2011). FDA and FSIS collaborated, in consultation with the CDC, to conduct a risk assessment of L. monocytogenes. In this section, the committee discusses that risk assessment and the uncertainty analyses in it and also discusses how FDA has used the results of that risk assessment to refine its policies around the control of L. monocytogenes in different food products within its regulatory purview. Regulatory Background L. monocytogenes can contaminate food contact surfaces and also non-food contact surfaces, such as floors and drains in food-processing facilities. The growth of L. monocytogenes is more difficult to control than the growth of most other bacteria. Temperatures at or below 40°F control the growth of most bacteria, but L. monocytogenes survives on cold surfaces and can multiply slowly at 32°F; temperatures of 0°F are required to completely stop L. monocytogenes from multiplying (FDA and FSIS, 2003b).

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136 ENVIRONMENTAL DECISIONS IN THE FACE OF UNCERTAINTY In October 2010 the ACIP adopted a new framework for developing its recommendations, the Grading of Recommendations, Assessment, De- velopment and Evaluation (GRADE) approach (Ahmed et al., 2011). The key factors in that approach include “the balance of benefits and harms, type of evidence, values and preferences of the people affected, and health economic analyses” (Ahmed et al., 2011, p. 9171). In the GRADE ap- proach, ACIP includes tables that summarize the evidence on which it basis its decision. The tables include a description of the strength and limitations of the body of evidence. Those tables are intended to “enhance the ACIP’s decision-making process by making it more transparent, consistent and systematic” (Ahmed et al., 2011, p. 9171). Decisions in the Face of Uncertainty: Lessons Learned Vaccinations illustrate a number of challenges experienced by those making decisions in the face of uncertainty. Viruses are “moving targets” that evolve and change, often requiring major policy decisions to be made in the absence of a full knowledge of the characteristics of future viruses. Faced with a possible pandemic in 1976, the government embarked on a vaccination campaign that has often been criticized. The lessons learned from that decision include the need for deliberative problem formulation, the importance of having different options, and the value of considering the potential effectiveness of those options in advance (for example, shutting down schools to control the spread of influenza). Other lessons from this case study are the importance of implementing an iterative approach in the presence of uncertainty, considering the feasibility of a plan, the importance of preparing for media communications, the importance of credibility, and the value of questioning knowledge and considering uncertainties in knowl- edge (Neustadt and Fineberg, 1978). CDC’s ACIP was faced with making recommendations about whom and when to vaccinate with a newly available, but expensive, vaccine against HPV that could prevent cervical cancer. A number of very detailed cost-effectiveness analyses were available that provided the ACIP with estimates of the benefits and costs associated with a number of different vaccination programs, assuming different levels of benefit. Those extensive analyses—which included analyses of a number of uncertainties—allowed ACIP to consider the effects of different scenarios and the range of benefits and costs under those scenarios using different estimates of vaccine effec- tiveness. ACIP’s decision would potentially affect the medical care of the entire U.S. adolescent population. Having the detailed analyses showing ranges of cost effectiveness provided the ACIP with the evidence it needed to make a decision.

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UNCERTAINTY AND DECISION MAKING 137 U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS At the level of individual patients, physicians often make decisions or recommendations about preventive or therapeutic interventions with very uncertain information. They do so based on experiences from their training, advice from their professional societies, and information from government agencies and relevant private industries and by keeping current with the published medical literature and knowing their patients. In contrast to the population-based decisions that EPA makes, the decisions that physicians make or the advice they give is for one patient at a time, and the evidentiary basis for that advice typically comes from studies in populations and expert systematic reviews of the published literature, which may have different applicability to different patients. There is often conflicting evidence about the safety and effectiveness of the interventions. For example, although the U.S. Preventive Services Task Force (USPSTF) does not conduct quantita- tive uncertainty analysis when making its recommendations, the language of its recommendations qualitatively describes the level of uncertainty in the evidence (USPSTF, 2008). The USPSTF conclusions have significant policy implications. The role of certainty is explicitly stated in the conclu- sions and in the communication of the scientific evidence, providing an example of how a qualitative assessment and the description of uncertain- ties in an evidence base can provide important information to a decision maker. For example, the most strongly worded conclusion—for preventive interventions receiving a grade of A—reads, “The USPSTF recommends the intervention. There is high certainty that the net benefit is substantial.” The Grade B conclusion reads, “The USPSTF recommends the service. There is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial” (USPSTF, 2008). Unfortu- nately, for many interventions there is no clinical guidance given because the evidence is confusing or inadequate. Decisions in the Face of Uncertainty: Lessons Learned The USPSTF guidelines demonstrate how, for some types of decisions, simple, qualitative descriptions of the uncertainty can be helpful for the decisions. KEY FINDINGS • Some agencies, such as FSIS and FDA, have conducted quantitative uncertainty analyses on public health estimates. They use tools and techniques, such as probabilistic analysis and Monte Carlo simula- tions, that are similar to those that EPA has used.

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138 ENVIRONMENTAL DECISIONS IN THE FACE OF UNCERTAINTY • A phased or iterative approach to regulations, as occurred with the implementation of smoking bans, can allow for the collection of data, including data for economic analyses, that can decrease uncertainty. • Regulations that are likely to be met with opposition, such as smoking bans and mandatory vaccinations, are well served to en- gage stakeholders in problem formulation and uncertainty analysis early to ensure that uncertainties are well understood and to ensure that stakeholders’ information needs are met. • Uncertainty analyses, such as those conducted in the assessment of L. monocytogenes, can characterize heterogeneity and its con- sequences and provide decision makers with the information to decide upon regulations and risk-mitigation options that target the public health goal in the most effective manner. • Well-planned, decision-driven modeling of uncertainty, such as was conducted in the BSE risk assessment, can provide information about the likelihood of different regulatory options decreasing the risks to the public. • Decisions must sometimes be made quickly in the face of large or deep uncertainty, such as was the case with the threatened pandemic influenza in 1976 and with melamine in the food sup- ply in 2007 and 2008. Under such circumstances, probabilistic models are not typically available to help with decision making. The analysis of scenarios can be useful under such circumstances, and iterative management approaches can avoid mistakes that are costly either in terms of resources or to the reputation of and trust in the agency. • Detailed economic analyses that outline the ranges of likely cost- effectiveness of different scenarios, such as those conducted for HPV vaccinations, can provide the evidence needed to make a decision. • As demonstrated by FDA’s activities around its decision on Avan- dia, making public the uncertainty from scientific disagreements— and even the disagreements among agency scientists—can increase the transparency and the public understanding of a decision. That decision also highlights how quantitative uncertainty analyses are not always needed to make an informed decision. • All of these examples provide some characterization of uncertainty— some quantitative, some qualitative, some using safety factors— some in public health factors only and some in costs and economic impacts as well. These examples show the wide range of approaches that can be taken and provide some indication of the situations in which each approach may be appropriate. These examples also

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