Health and Environmental Risk Assessment

book.

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INTRODUCTION

INTRODUCTION TO INTRODUCTION

Paolo F. Ricci*

WHY RISK ANALYSIS?

Technology produces benefits such as energy, employment, increased standards of living, and better health, but in so doing it adds to the existing burden of risks and distributional inequities.** Risk-benefit assessment studies the trade-offs that society makes between risks and benefits. In this paper, we limit the discussion to the issues that arise when one analyzes public and occupational health risks, for a technology per se, at the regional and national level. The focus is on energy-producing technologies and the fuel, activity, and material cycles that create and maintain technology. These cycles result in routine releases of liquid, solid, and gaseous pollutants and, thus, frequent and infrequent accidents with both small and large consequences.

Risks may be encountered long before they are recognized. Once they are recognized and quantified with some certainty, it may be too late to control or limit them. The question of whether to wait for irrefutable evidence about an adverse effect or to take what may be a costly course of action is a policy question that cannot be answered by the analyst. Yet it is necessary to know what the likely risks and benefits are, even though there is considerable fuzziness about the causes and effects of many health risks. Finally, common sense propels the need to analyze and evaluate risks to human health, the costs of controlling these risks, and the possible benefits of technology, which are uncertain. Thus, it makes good sense to not only account for the beneficial or adverse effects a technology imposes on society but also to characterize and reduce the uncertainty about each of these. Moreover, as laws, regulations, and court decisions increasingly rely on estimates of risks and benefits to set standards for protection of health or the environment, there is a pressing need to develop methods that are quantitative and reliable. We suggest here that the analysis of risk consists of determining a hazard, the likelihood that the hazard may occur, and the associated adverse consequences. The assessment extends the analysis to include private and societal evaluation of risk. Risk analysis is the systematic accounting of risks and thus provides the assessment with much information. Nevertheless, the knowledge of risks, costs, and benefits is not sufficient for an assessment. A principal ingredient is the acceptance of a technology by the public and the decision makers. Ultimately, political resolution is inevitable, since decisions about what level of health risk is acceptable by society are resolved by society through its institutions (2).

The fundamental question within which health risk analysis finds its reason to be, and may find its ultimate damnation, is in helping to determine whether energy or environmental policies (and, one might add, institutional arrangements) achieve minima in total health risks from a given set of technological options. Admittedly, this is a single objective that, of itself, does not necessarily justify the choice of a particular policy. Yet, health risk still performs a much needed function (3, 4).

It is becoming increasingly apparent that ‘safe’ is not equivalent to risk-free and that, as the U.S. Supreme Court noted,

the mere possibility that some employee somewhere … may confront some risk of cancer is a sufficient basis for … expenditures of hundreds of millions of dollars to minimize the risk. (Industrial Union Dept., AFL-CIO, v. American Petroleum Institute, 100 S.Ct. 2844, 66 L. Ed. 2d. 268, 1980)

However, judicial decisions indicate that the scientific evidence under which risks are determined should be subjected to careful scrutiny (5). Moreover, the precise meaning of de minimis, the often-found wordings of reasonable risk, ample margin of safety, and similar phrases found among the environmental statutes enacted by Congress, have had a profound impact on the analysis of risks. The key point is that an analysis must be made, so that what does and what does not constitute reasonable or de minimis risk can be assessed from scientific evidence.

Risk to human health is a cost. Its units are not monetary; rather, they are man-days lost, injuries, or deaths. Of course, there may also be direct monetary costs, such as the cost of cleaning up an oil spill or the loss of energy in the operation of pollution control equipment, but normally, costs may be quite indirect and often cannot be quantified in monetary units.

We do not discuss the cost of bearing risk, which is the amount of money an individual or other unit of the economy would be willing to pay to avoid uncertainty (e.g., uncertainty introduced by economic or other institutional factors affecting the cost of production). Nor do we address how uncertainty affects technological choices, the level of economic output, and the mix of goods and services provided by the economy. Neither do we discuss the discounting of small and large risks. Although there are parallels between the analysis of uncertainty–and thus the analysis of risk–in economic and related literature, we limit our discussion to health risk analysis. We also cannot treat ecological or other environmental risks, nor do we discuss terrorism or geopolitical risks.

A wide variety of benefits must also be considered, although they are not fully discussed here. The energy technology under analysis may prove more reliable and efficient than the one it replaces. Often there may be beneficial social changes, including increased employment. There may be less tangible benefits, such as the increased recreational opportunities that result from damming a river to reduce flood hazard, to be balanced against the intangible benefits of white-water recreation and the value of the loss of the free-flowing river (6).

SYSTEMIC ISSUES IN RISK ANALYSIS

Bounding, Variability, and Uncertainty

Most analyses are made to meet an objective; thus, there are issues which are upstream of the use of data or models. We summarize five of these issues here to set the stage for the discussions that follow:

• Choice of objective (e.g., to minimize societal health risks)

• Choice of criteria for calculating risks (e.g., expected value of risk)

• Units used in the analysis (e.g., deaths per 1000 MW(e), deaths per million tons of ore mined, injuries per employee)

• Boundaries of the analysis (e.g., the inclusion of primary activities or the associated fuel, materials, and activity cycles)

• Whether a single plant is analyzed or whether systemwide effects from various mixes of plants of different vintage and operating characteristics are to be included

Two operational factors affect the analysis of health risks to a great extent: variability and uncertainty (7). Variability–which is usually unavoidable in applied research–means that different researchers assume different design or operating parameters for the same technology. These differences are normally reconcilable. Uncertainty cannot be dealt with so easily.* It is introduced by such factors as:

1. Reliance on derived data

2. Inappropriate units of analysis (e.g., SIC aggregate data may not be appropriate for the objective of an analysis)

3. The choice of model or models

4. Interspecies comparisons (e.g, mice-to-human extrapolation of carcinogenic potency)

5. Animal experiments not sufficiently sensitive to detect a health effect

6. Errors in computer code development, or lack of validation of codes

7. Unknowability of cause-and-effect relationships (e.g., biologically plausible relationships against statistical correlations)

The logic we apply in the sections that follow is set into motion by events such as the release of pollutants or by less frequent events such as floods from failed dams. The logic can be summarized as follows:

Events (frequency, circumstances, magnitude)→exposure (sequence, transport, fate, distribution, populations at risk)→damage (intensity, magnitude).

The key components are the sources that emit hazardous materials during the production of energy or from other industrial activities. The releases are solid, liquid, and gaseous pollutants. The behavior and fate of those pollutants in air, water, and the soil is complex; for example, many pollutants react chemically to change phase and concentrations during diffusion. Damage to exposed humans takes many forms and is of varying levels of severity; it depends very much on the intensity of exposure to the concentrations of pollutants and metabolic or immunologic processes within the human receptor. Assessing the overall risk requires knowledge of the populations exposed.

The logic that links hazards to exposure to health damage provides precise estimates of risk. The outstanding issue is one of statistical uncertainty about the estimates. The question is, What is the overall effect of the inaccuracy of the data and models used to calculate emissions and transform these emissions into ambient concentrations and exposure levels to measure societal risk? We turn to this question next.

THE BASIC BLOCKS OF RISK ANALYSIS

The analysis of health risks requires many steps, ranging from identifying hazards to establishing and parameterizing dose-response functions. (We outline those steps here and discuss them in detail in the sections that follow.) The analysis begins with judgments about the existence of potential hazards, such as releases of hazardous substances, failure of a dam, or others (8). Estimates of the low probability of high-magnitude events are difficult to obtain because the events are rare or have never occurred.* The probability distribution for this general type of risk can, however, be estimated from the available data for less extreme cases; a class of statistical distributions, known as extreme value distributions, has proved useful in estimating extreme probabilities for natural hazards such as floods and earthquakes. Estimates of releases are described by probability distributions, as is the case for accidental releases of radioactive material from a nuclear power plant (9). In other instances, releases are continuous and relatively well documented, as in the case of sulfur emitted by coal-burning power plants.

Generally, risks from catastrophic or nonroutine events should be treated separately from routine ones, but their analyses have many points in common. The phenomena, and probabilities of occurrence of such phenomena, lead to releases which may be either large or small but are always continuous. Events leading to such releases are treated through event-tree and fault-tree analysis. Fault-tree analysis assumes a given state of the system under analysis and deductively, from a specific adverse event, relates to it intermediate and initiating events, which are then combined through Boolean logic statements. The event-tree approach assumes a specific state of a given component and inductively begins with an initiating event. It relates a time sequence of intermediate events leading to final adverse events and includes the probabilities of occurrence of each event, combining them according to theorems of axiomatic probability. Both the fault-tree and the event-tree approaches can be combined to determine accident sequences; this was done in WASH-1400 (10) and the German Reactor Safety Study (11). The drawbacks of those methods include lack of data, occurrence of common modes of failure, completeness of the logic tree, hidden assumptions about failure rates and their distributions, and the difficulty of these methods resulting from both human and design errors. The advantages include an accurate representation of the risks, the likely benefits, and–to some extent–valuable information for policy