Environmental Decisions in the Face of Uncertainty (2013) / Chapter Skim
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1 Introduction
1 Introduction
Pages 19-46
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But decisions need to be made despite those uncertainties. The available data on the multiple factors, including human health risk, that shape environmental decisions rarely encompass all relevant considerations.
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A challenge for EPA is to determine how to best develop and use those estimates of uncertainty in data and analyses in its decision-making processes. UNCERTAINTY AND ENVIRONMENTAL DECISION MAKING Human health risk assessment3 is one of the most powerful tools used by EPA in making regulatory decisions to manage threats to health and the environment.
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The risk characterization should include a statement about the scientific uncertainties associated with the assessment and their effect on the assessment, including a clear description of the confidence that the technical experts have in the results. Such information is provided to decision makers at EPA for consideration in their regulatory decisions (EPA, 2000; NRC, 2009)
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Other statutes require judgments relating to the "potential" for environmental harm and "a reasonable certainty that no harm will result."6 Congress's recognition of the uncertainty inherent in factors other than human health risks is also evident, for example, in such statements as "reasonably ascertainable economic consequences of the rule."7 Such statements indicate a recognition by Congress that, at the time of a regulatory decision, data and information may be incomplete, controversial or otherwise open to variable interpretations, or that use of the available data and information may require assumptions about future events and conditions that are unknown or uncertain at the time of the rulemaking. Although the statutory language may seem vague and incomplete, the fact that such language was incorporated into a law by Congress indicates a recognition that EPA should have the discretion to interpret the statute and to develop approaches informed by agency experience, expertise, and decision-making needs.
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8 requires EPA to report to Congress on "any uncertainties in risk assessment methodology or other health assessment technique, and any negative health or environmental consequences to the community of efforts to reduce such risks." The Clean Water Act (CWA) Amendments9 require EPA to specify, in a publicly available document, "to the extent practicable .
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To try to bridge that gap, the scientific community has endeavored to provide regulatory decision makers with a more comprehensive view of the estimates of risks, and a number of scientific reports have been published that focus on regulatory decision making and, to some extent, on the uncertainties inherent in the information that supports EPA's human health regulatory decisions and on the implications of that uncertainty. Over the past three decades two core themes, which were outlined in the germinal report Risk Assessment in the Federal Government: Managing the Process (hereafter the Red Book)
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(NRC, 1996) , discussed the uncertainty inherent in estimates of health risks in the broad context of regulatory decisions, including those made by EPA.
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26 ENVIRONMENTAL DECISIONS IN THE FACE OF UNCERTAINTY The final report of the Presidential/Congressional Commission on Risk Assessment and Risk Management (1997a) recommended a risk management framework geared toward environmental risk decisions (see Figure 1-1)
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and stakeholders with opportunities to revisit stages within the framework when new information emerges. When discussing uncertainty in health risk characterizations for routine risk assessments, the report recommended using qualitative descriptions of uncertainty rather than quantitative analyses, because it "is likely to be more understandable and useful than quantitative estimates or models to [decision makers]
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Although a number of those reports discuss the factors beyond the estimates of health risks that play a role in regulatory decision making, when discussing the analysis and implications of uncertainty on decision making they focus on the uncertainty in the estimates of human health risks. The reports typically do not discuss the uncertainty inherent in the other factors that are considered in regulatory decisions.
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While a substantial database may exist for any particular chemical undergoing regulatory review, uncertainties invariably raise questions about the reliability of risk estimates and the scientific credibility of related regulatory decisions. Because some aspects of interpreting uncertainty are subjective, different risk assessors, regulators, and observers who approach the use of risk assessments and uncertainty analyses from different perspectives might have different interpretations of the results.
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. provide its best judgment and rationale on how best to use quantitative information on uncertainty in the estimates of risk in order to manage environmental risks to human health and for communicating this information."22 The specific questions that EPA requested the committee to address are presented in Box 1-2.
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risk management under different public health policy scenarios? " However, the committee found it more useful to deliberate on how uncertainty can and should influence decisions and help decision makers, rather than focusing on how it currently influences risk-management decisions.
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For example, the drinking water standards promulgated under the Safe Drinking Water Act24 require that certain costs and technological availability be considered. In contrast, the standards that EPA promulgates under the NAAQS Act25 consider only the protection of public health, although state regulators can consider costs, feasibility, and other factors when developing implementation plans to meet the NAAQS.
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to discrimination under, such programs, policies, and activities, because of their race, color, or national origin."31 Factors that are involved in regulatory decision making have been discussed before. For example, EPA's Risk Characterization Handbook describes seven factors that influence decision making: risk assessment, economic factors, technological factors, legal factors, social factors, political factors, and public values (EPA, 2000)
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and the political context. Some of those factors are discussed in key statutes under which EPA operates, and numerous EPA guidance documents on risk assessments acknowledge those factors.
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The decision maker uses the results of the risk characterization, other technological factors, and non-technological social and economic considerations in reaching a regulatory decision.
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That legal context also, to a large extent, determines the other factors that EPA considers in its decisions, in particular, human health risks, technological, and economical factors. At the same times those laws allow considerable discretion in the development and implementation of environmental regulations.
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When approaching its charge, the committee was aware that the consideration of uncertainty by EPA in its regulatory decisions could be evaluated in a number of ways. The uncertainty in decisions could be evaluated solely on the standard that is set -- that is, whether a standard limiting the amount of ozone in air or arsenic in drinking water or establishing remediation levels for a hazardous waste site is adequate or too protective.
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Chemical risk assessors typically consider uncertainty and variability to be separate and distinct, but in other fields uncertainty encompasses statistical variability and heterogeneity as well as model and parameter uncertainty (Swart et al., 2009)
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. In addition, even reports related to chemical risk assessment highlight the importance of evaluating both uncer tainty and variability in risk assessments and considering both in the decision making process (NRC, 1983, 1994, 2009)
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. Such disagreements add to the uncertainty when making a decision on the basis of that information, and, therefore, the committee considers scientific disagreements when discussing uncertainty.
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Box 1-4 presents an example of a decision made in the face of deep uncertainty. Neither the collection nor the analysis of data nor expert elicitation to assess uncertainty is likely to be productive when key parties to a decision
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And again two years would pass before such information would be available. A quick decision was needed despite the deep uncertainty surrounding the risks of creating an epidemic of BSE in infants; there was no time to decrease that uncertainty.
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The committee then moves beyond that narrow focus of uncertainty in EPA's decisions and in Chapter 3 looks at the uncertainty inherent in other factors that play a role in EPA's regulatory decisions, that is, the economic, technological, social, and political factors. In Chapter 4 the committee examines decision making in other public health policy settings to examine whether the tools and techniques used in those fields could improve EPA's decision-making processes.
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2007. Benefits and costs of Clean Air Act -- direct costs and uncertainty analysis.
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INTRODUCTION 45 Swart, R., L Bernstein, M
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