| Preface |
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vii | |
| Acknowledgments |
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ix | |
| 1.0 Introduction |
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1 | (8) |
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5 | (1) |
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6 | (1) |
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7 | (2) |
| 2.0 Exposure Characterization |
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9 | (10) |
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10 | (4) |
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2.2 Material characteristics |
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14 | (2) |
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2.3 Risk group characteristics |
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16 | (1) |
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17 | (2) |
| 3.0 Qualitative Evaluation of Human and Animal Studies |
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19 | (24) |
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20 | (1) |
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3.2 Latent period, effective exposure, and followup |
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21 | (2) |
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3.3 Matching of experimental and risk groups |
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23 | (2) |
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3.4 Animal studies: special considerations |
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25 | (2) |
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3.5 Epidemiology studies: special considerations |
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27 | (3) |
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3.6 Classification of toxicants by health effect and dose-response character |
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30 | (8) |
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31 | (4) |
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35 | (2) |
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3.6.3 Developmental toxicants |
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37 | (1) |
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3.6.4 Organ/tissue toxicants |
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38 | (1) |
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38 | (1) |
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38 | (4) |
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3.7.1 Threshold limit values (TLVs) and permissible exposure limits (PELs) |
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39 | (1) |
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39 | (1) |
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40 | (1) |
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40 | (1) |
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3.7.5 Hierarchy of data selection |
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41 | (1) |
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42 | (1) |
| 4.0 Quantitative Evaluation of Human and Animal Studies |
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43 | (18) |
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4.1 Calculation of human dose from animal and human studies |
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44 | (4) |
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4.2 Quantitation of response |
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48 | (3) |
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4.3 Tests of significance |
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51 | (5) |
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4.4 Calculation of control-adjusted test group response |
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56 | (1) |
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4.5 Calculation of the upper limit of control-adjusted test group response |
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57 | (4) |
| 5.0 Risk Analysis |
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61 | (12) |
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5.1 Individual excess risk |
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61 | (4) |
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5.1.1 Experimental dose range |
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61 | (1) |
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5.1.2 Subexperimental dose range |
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62 | (1) |
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5.1.3 Risk factor analysis |
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63 | (2) |
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5.1.4 Plausibility analysis |
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65 | (1) |
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65 | (7) |
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5.2.1 Experimental dose range |
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65 | (1) |
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5.2.2 Subexperimental dose range |
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66 | (6) |
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72 | (1) |
| 6.0 Acceptable Concentrations |
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73 | (10) |
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6.1 Risk analysis method for toxicants with zero thresholds (e.g. carcinogens) |
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74 | (3) |
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6.1.1 Acceptable individual excess risk |
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74 | (2) |
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6.1.2 Acceptable number of excess cases |
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76 | (1) |
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6.2 Safety factor method for toxicants with nonzero thresholds |
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77 | (6) |
| 7.0 Example: Environmental and Occupational Exposure to a Hypothetical Industrial Toxicant |
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83 | (14) |
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7.1 Solutions based on a rat study |
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86 | (8) |
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7.1.1 Lowest effective human dose |
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86 | (1) |
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7.1.2 Test and control group response |
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87 | (1) |
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7.1.3 Statistical significance of the difference between test and control group responses |
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88 | (1) |
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7.1.4 Control-adjusted test group response |
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88 | (1) |
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7.1.5 Upper limit of the control-adjusted test group response |
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88 | (1) |
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7.1.6 Maximum dose to an individual in the general population |
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89 | (1) |
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7.1.7 Maximum individual excess risk for the general population and workers |
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89 | (1) |
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90 | (1) |
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7.1.9 Maximum individual excess risk for the general population and workers |
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90 | (1) |
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7.1.10 Excess cases and excess cases per year for the general population |
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90 | (1) |
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7.1.11 Excess cases and excess cases per year for workers |
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91 | (1) |
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7.1.12 Acceptable concentrations for the general population |
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92 | (1) |
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7.1.13 Acceptable concentrations for workers |
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93 | (1) |
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7.2 Solutions based on an occupational epidemiology study |
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94 | (4) |
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7.2.1 Lowest effective human dose |
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94 | (1) |
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7.2.2 Test and control group response |
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95 | (1) |
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7.2.3 Statistical significance of the difference between test and control group responses |
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95 | (1) |
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7.2.4 Control-adjusted test group response |
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96 | (1) |
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7.2.5 Upper limit of the control-adjusted test group response |
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96 | (1) |
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7.2.6 Maximum dose to an individual in the general population |
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96 | (1) |
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7.2.7 Maximum individual worker dose |
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96 | (1) |
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96 | (1) |
| 8.0 Example: Environmental Exposure to a Natural Toxicant, Radon-222 and its Daughters |
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97 | (24) |
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8.1 Exposure characterization |
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98 | (2) |
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8.2 Evaluation of studies |
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100 | (7) |
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8.2.1 Swedish iron miners study |
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102 | (1) |
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8.2.2 Czechoslovakian uranium miners study |
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103 | (1) |
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8.2.3 Colorado uranium miners study |
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104 | (1) |
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8.2.4 Epidemiological study analyses |
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104 | (3) |
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107 | (5) |
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8.3.1 Equations for probability |
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107 | (1) |
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8.3.2 Adjustments for latency |
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108 | (1) |
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8.3.3 Calculation of risks |
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109 | (1) |
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8.3.4 Sensitivity analysis |
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109 | (3) |
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112 | (1) |
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8.5 Comparison of results to other estimates of risk |
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113 | (2) |
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8.6 Sources of uncertainty |
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115 | (1) |
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8.7 Public health and regulatory implications |
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116 | (2) |
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118 | (1) |
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119 | (2) |
| References |
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121 | (11) |
| Appendices |
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132 | (63) |
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1 Lower 1% and Upper 99% Limits for a Binomial Variable |
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133 | (40) |
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2 Glossary of Terms, Abbreviations, and Acronyms |
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173 | (6) |
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179 | (4) |
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4 U.S. Food and Drug Administration Risk Analysis Method for Carcinogens |
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183 | (2) |
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5 Physical and Radiological Characteristics of Radon and Radon Daughters |
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185 | (4) |
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6 Definitions of Radiological Terms |
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189 | (2) |
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7 Calculation of Working Level Months |
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191 | (4) |
| Index |
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195 | |
Lisainfo e-raamatute kohta