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Science and Judgment in Risk Assessment (1994)
Board on Environmental Studies and Toxicology (BEST)

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. "10 Variability." Science and Judgment in Risk Assessment. Washington, DC: The National Academies Press, 1994.

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Page 189

are created to fundamentally misunderstand or misestimate the behavior of the quantity.

To draw an analogy, the exact distance between the earth and the moon is both difficult to measure precisely (at least it was until the very recent past) and changeable, because the moon's orbit is elliptical, rather than circular. Thus, as seen in Figure 10-1, uncertainty and variability can complement or confound each other. When only scattered measurements of the earth-moon distance were available, the variation among them might have led astronomers to conclude that their measurements were faulty (i.e., ascribing to uncertainty what was actually caused by variability) or that the moon's orbit was random (i.e., not allowing for uncertainty to shed light on seemingly unexplainable differences that are in fact variable and predictable). The most basic flaw of all would be to simply misestimate the true distance (the third diagram in Figure 10-1) by assuming that a few observations were sufficient (after correcting for measurement error, if applicable). This is probably the pitfall that is most relevant for health risk assessment: treating a highly variable quantity as if it was invariant or only uncertain, thereby yielding an estimate that is incorrect for some of the population (or some of the time, or over some locations), or even one that is also an inaccurate estimate of the average over the entire population.

In the risk-assessment paradigm, there are many sources of variability. Certainly, the regulation of air pollutants has long recognized that chemicals differ from each other in their physical and toxic properties and that sources differ from each other in their emission rates and characteristics; such variability is built into virtually any sensible question of risk assessment or control. However, even if we focus on a single substance emanating from a single stationary source, variability pervades each stage from emission to health or ecologic end point:

Emissions vary temporally, both in flux and in release characteristics, such as temperature and pressure.

The transport and fate of the pollutant vary with such well-understood factors as wind speed, wind direction, and exposure to sunlight (and such less-acknowledged factors as humidity and terrain), so its concentrations around its source vary spatially and temporally.

Individual human exposures vary according to individual differences in breathing rates, food consumption, and activity (e.g., time spent in each micro-environment).

The dose-response relationship (the "potency") varies for a single pollutant, because each human is uniquely susceptible to carcinogenic or other stimuli (and this inherent susceptibility might well vary during the lifetime of each person, or vary with such things as other illness or exposures to other agents).

Each of these variabilities is in turn often composed of several underlying variable phenomena. For example, the natural variability in human weight is due to the interaction of genetic, nutritional, and other environmental factors.

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Front Matter (R1-R16)
Executive Summary (1-15)
1 Introduction (16-22)
Part I Current Approaches to Risk Assessment: 2 Risk Assessment and its Social and Regulatory Contexts (23-42)
3 Exposure Assessment (43-55)
4 Assessment of Toxicity (56-67)
5 Risk Characterization (68-78)
Part II Strategies for Improving Risk Assessment: 6 Default Options (79-105)
7 Models, Methods, and Data (106-143)
8 Data Needs (144-159)
9 Uncertainty (160-187)
10 Variability (188-223)
11 Aggregation (224-242)
Part III Implementation of Findings: 12 Implementation (243-268)
References (269-286)
Appendix A: Risk Assessment Methodologies: EPA (287-350)
Appendix B: EPA Memorandum from Henry Habicht (351-374)
Appendix C: Calculation and Modeling of Exposure (375-382)
Appendix D: Working Paper for Considering Draft Revisions to the U.S. EPA Guidelines for Cancer Risk Assessment (383-448)
Appendix E: Use of Pharmacokinetics to Extrapolate from Animal Data to Humans (449-452)
Appendix F: Uncertainty Analysis of Health Risk Estimates (453-478)
Appendix G: Improvement in Human Health Risk Assessment Utilizing Site- and Chemical-Specific Information: A Case Study (479-502)
Appendix H-1: Some Definitional Concerns About Variability (503-504)
Appendix H-2: Individual Susceptibility Factors (505-514)
Appendix I: Aggregation (515-536)
Appendix J: A Tiered Modeling Approach for Assessing the Risks Due to Sources of Hazardous Air Pollutants (537-582)
Appendix K: Science Advisory Board Memorandum on the Integrated Risk Information System and EPA Response (583-590)
Appendix L: Development of Data Used in Risk Assessment (591-598)
Appendix M: Charge to the Committee (599-600)
Appendix N-1: The Case for (601-628)
Appendix N-2: Making Full Use of Scientific Information in Risk Assessment (629-640)
Index (641-652)