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

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National Research Council. "Appendix B: EPA Memorandum from Henry Habicht." Science and Judgment in Risk Assessment. Washington, DC: The National Academies Press, 1994. 1. Print.

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Page 371

sarily represent a particular individual on the distribution. The Average Estimate is not very meaningful when exposure across a population varies by several orders of magnitude or when the population has been truncated, e.g., at some point prescribed distance form a point source.

Because of the skewness of typical exposure profiles, the arithmetic mean is not necessarily a good indicator of the midpoint (median, 50th percentile) of a distribution. A Median Estimate, e.g., geometric mean, is usually a valuable descriptor for this type of distribution, since half the population will be above and half below this value.

2. Information about population exposure leads to another important way to describe risk.

Population risk refers to an assessment of the extent of harm for the population as a whole. In theory, it can be calculated by summing the individual risks for all individuals within the subject population. This task, of course, requires a great deal more information than is normally, if ever, available.

Some questions addressed by descriptors of population risk include:

How many cases of a particular health effect might be probabilistically estimated in this population for a specific time period?

For noncarcinogens, what portion of the population are within a specified range of some benchmark level, e.g., exceedance of the RfD (a dose), the RfC (a concentration), or other health concern level?

For carcinogens, how many persons are above a certain risk level such as 10-6 or a series of risk levels such as 10-5, 10-4, etc?

Answering these questions requires some knowledge of the exposure frequency distribution in the population. In particular, addressing the second and third questions may require graphing the risk distribution. These questions can lead to two different descriptors of population risk.

The first descriptor is the probabilistic number of health effect cases estimated in the population of interest over a specified time period.

This descriptor can be obtained either by (a) summing the individual risks over all the individuals in the population when such information is available, or (b) through the use of a risk model such as carcinogenic models or procedures

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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)
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