Index
A
Abbreviated Injury Scale (AIS), 216, 218, 222–223, 234
Acceptability of risks, dimensions of value affecting, 140–143
Accounting statements, 313–315
categories of benefits and costs, 313
effects on state, local, and tribal governments, small business, wages and economic growth, 315
precision of estimates, 314
qualitative benefits and costs, 313
quantifying and monetizing benefits and costs, 313
separate reporting of transfers, 314–315
treatment of benefits and costs over time, 313–314
treatment of risk and uncertainty, 314
Activities of daily living (ADL), 115n, 126n, 318
Administrative guidance, history of regulatory analysis, 22
Administrative Procedure Act (APA), 21
Air quality, 145
improving, 1
AIS. See Abbreviated Injury Scale
Alternative assumptions, 310
Alternative HALY metrics for regulatory CEA, 86–91
choosing a HALY measure for regulatory analysis, 91
disability-adjusted life years, 88–90
healthy year equivalents, 88
quality-adjusted life years, 86–88
saved-young-life equivalents, 90–91
Alternative regulatory approaches, 266–269
different choices defined by statute, 266
different compliance dates, 266
different degrees of stringency, 267
different enforcement methods, 266
different requirements for different geographic regions, 267
different requirements for different sized firms, 267
informational measures rather than regulation, 268–269
market-oriented approaches rather than
direct controls, 268
performance standards rather than design standards, 267
Alternatives, evaluation of, 277–278
American Petroleum Institute v. OSHA, 45
Analytical approaches, 269–275
benefit–cost analysis, 269–270
cost-effectiveness analysis (CEA), 270–272
distributional effects, 274–275
the effectiveness metric for public health and safety rulemakings, 272–274
scope of, 275
to unfunded mandates, 311
Ancillary benefits and countervailing risks, 289–290
Anderson, Henry A., 326–327
Annualized values, 212
APA. See Administrative Procedure Act
Applicability issues, 117
Assessment of Quality of Life (AQoL) instrument, 126n
Assignment of health states by experts or other proxies, 106–109
expert assignment of health states using generic HRQL instruments, 110–111
Asymmetric information, 263–264
Availability issues, 98–102
Averaging, banking and/or trading (ABT) of credits, 268
B
Bacillus cereus, 204–210
Baseline, developing, 276–277
BAT. See “Best available technology”
Bayesian methods, 318
Benefit–cost analysis (BCA), 1–4, 7, 10–12, 15–22, 27–59, 64, 67, 129–134, 143–146, 151, 157, 168–174, 178–182, 188–189, 194, 197, 204, 214, 217, 229, 238, 241, 269–272, 292, 300, 318
calculation of net benefits, 31
valuation approach, 29–30
Benefit point transfer, 289
Benefits analysis guidelines, 51–55
monetized health-adjusted life years in benefit–cost analysis, 53
OMB criteria for evaluating stated preference studies, 54
Benefits and costs
ancillary benefits and countervailing risks, 289–290
benefit-transfer methods, 287–289
categories of, 313
developing estimates of, 279–296
discount rates, 296–303
identifying and measuring, 275–310
methods for treating non-monetized, 290–292
monetizing health and safety, 292–296
other key considerations, 303–305
qualitative, 313
quantifying and monetizing, 291–292, 313
revealed preference methods, 282–285
stated preference methods, 285–287
treatment of uncertainty, 305–310
treatment over time, 313–314
Benefits transfer, 4, 116–121, 318
methods for, 287–289
BenMAP model, 229
“Best available technology” (BAT), 44
Best practices, 258
in stated preference surveys and benefits transfer, 125
Board on Environmental Studies and Toxicology, 121
Brauer, Carmen, 120
“Break-even” analysis, 260
Bush, George H.W., 22
Bush, George W., 22
C
Calculation
of cost-effectiveness, 36–37
of health gains, 149–151
Carter, Jimmy, 22
Case study analytic approach, 193–244
conclusion, 240–241
EPA’s nonroad engine air emissions regulation, 228–240
FDA’s juice processing regulation, 204–215
general approach, 195–203
NHTSA estimates of annual quantified benefits, 218
NHTSA’s child restraints regulation, 215–228
purpose and scope, 193–195
Case study process, 196
Category rating (CR), 77–81, 98
CDS. See Crashworthiness Data System
CEA. See Cost-effectiveness analysis
CEA Registry, 118, 228, 235, 240
Center for Risk Analysis, 117
“Cessation lag,” 300
CFR. See Code of Federal Regulations
Charge to the committee, 2–3, 16–19
background, 16–18
OMB’s rationale for requiring CEA as part of regulatory analysis, 17
the task, 18–19
Child restraints anchoring, 145
Choices, different, defined by statute, 266
Chronic condition HRQL values, catalogues of, 111–113
Circular A-4, 3, 16, 23, 40, 50, 53–56, 62–65, 134, 146, 152–154, 174, 194–196, 217, 258–315
accounting statement, 313–315
alternative regulatory approaches, 266–269
analytical approaches, 269–275
effective date, 315
identifying and measuring benefits and costs, 275–310
introduction, 259–261
key components of, 50
need for Federal regulatory action, 261–265
regulatory analysis, 258–259
specialized analytical requirements, 310–313
Clean Air Interstate Rule, 58, 156
Code of Federal Regulations (CFR), 21
COI. See Cost of illness
Collecting data and conducting research to improve HRQL measurement and regulatory CEA, 13–14
recommendation 10, 13
recommendation 11, 13
recommendation 12, 13–14
Committee on Estimating the Health-Risk-Reduction Benefits of Proposed Air Pollution Regulations, 18
Committee on Summary Measures of Population Health, 18
Committee to Evaluate Measures of Health Benefits for Environmental, Health, and Safety Regulation, 2, 5, 15, 40, 94, 193
Common property resource and public good, externality of, 262–263
Communicating methods and results, 64–65
“Community” index values, 93, 136
Comparisons
of cost-effectiveness ratios, 176
of key features of BCA and CEA, 39
to “with condition” values based on expert assignment, 202
to “with condition” values based on patient self-assessments, 202–203
Comparisons among elicitation methods, 81–86
empirical validity, 83–85
feasibility, 81–82
reliability, 82–83
theoretical reliability, 83
Competitive Enterprise Institute v. NHTSA, 49–50
Compliance cost
per life year gained, 167, 170
Compliance dates, different, 266
Comprehensive ratio, 167, 170–171
Condition-specific indexes and applications to special populations, 102–106
HRQL measurement for children, 106–107
special populations, 104–105
Congress, 42
Construct validity, 318
Consumer Product Safety Act, 43
Consumer Product Safety Commission (CPSC), 26, 46
Consumer surpluses, 281
Contingent valuation approach, 125, 318
“Control of Emissions from Nonroad Diesel Engines,” 303
Convergent validity, 318
Correlations, 318
and conversions among HRQL measures, 123–124
and cross-walks of HRQL measures, 126–127
Corrosion Proof Fittings v. EPA, 45
Cost, 319
Cost-effectiveness analysis (CEA), 1–4, 7–22, 27–28, 31–41, 46–58, 64–73, 83–88, 92, 103–105, 109–110, 116–119, 123–189, 194, 214, 217, 228, 236–241, 270–272, 285, 292, 300, 319
calculation of, 36–37
valuation approach, 32–36
Cost-effectiveness ratios, 10, 212–215, 237–240
compliance cost per death averted, 170
compliance cost per life year gained, 170
components of, 168
comprehensive ratio, 170–171
constructing and reporting, 11–12, 167–181
defining, 171–173
disaggregated impacts, 177
examples of, 169
examples of cost-effectiveness ratios, 169
health-benefits-only ratio, 170
nonmonetized benefits of the Environmental Protection Agency’s nonroad diesel rule, 179–180
recommendation 2, 11–12, 167–173
Cost of illness (COI), 30, 33n, 319
Cost per life year ($/LY), 73
Cost per quality adjusted life year ($/QALY), 36, 73
CPSC. See Consumer Product Safety Commission
CR. See Category rating
Crashworthiness Data System (CDS), 218
Criteria for selecting integrated effectiveness measures for regulatory CEA, 7, 162
Criteria for selecting HALY metrics for regulatory CEA, 68–72
standard performance criteria for HRQL instruments, 70
Criterion validity, 319
Cryptosporidium parvum, 204–210
Current practices for regulatory analysis, 50–65
benefits analysis guidelines, 51–55
current valuation practices, 55–62
key analytic requirements of OMB guidelines, 51
other guidelines relavant to CEA, 62–65
Current valuation practices, 55–62
EPA’s morbidity inclusive life year (MILY) approach, 60–61
FDA’s benefit valuation approach, 59
maximum abbreviated injury scale (MAIS) categories used in NHTSA analyses, 58
NHTSA’s equivalent lives saved (ELS) approach, 60–61
quantified benefits of EPA’s nonroad diesel rule, 56
quantified benefits of the FDA’s juice processing rule, 57
D
DALY. See Disability-adjusted life year
Data collection and research needed to improve HRQL measurement and CEA for regulatory decision making, 184–188
direct and indirect uses of data, 283–285
recommendation 10, 185–186
recommendation 11, 186
recommendation 12, 187–188
Deaths averted, defined, 171
Decision analysis, 319
Decomposed valuation approach, 97
Degrees of stringency, different, 267
Delayed effects, risks with, 142
“Delphi methods,” 111, 309, 319
Department of Agriculture, 58
Department of Energy (DOE), 278
Department of Health and Human Services (DHHS), 13, 116, 186–187
Direct health care costs, 33
Direct non-health care costs, 33
Direct rating, category rating and visual analogue scales, 79–80
Direct uses of market data, 283–284
Disability, defined, 319
Disability-adjusted life year (DALY), 80–81, 88–91, 319
the WHO’s DALY, 89
Disaggregated impacts, 176–177
Disclosure, full, 314
Discount rates, 296–303
intergenerational discounting, 301–302
the rationale for discounting, 297–298
real discount rates of 3 percent and 7 percent, 298–300
social, 323
time preference for health-related benefits and costs, 300–301
time preference for non-monetized benefits and costs, 302–303
Discounting, 152–154, 209, 319
the rationale for, 297–298
and timing of impacts, 63, 153
Distributional concerns about risks and regulatory interventions, 144–155, 183
calculation of health gains, 149–151
children, 146–148
comparing cost-effectiveness ratios, 154–155
distributional considerations in regulatory decisions, 147
population health data and subgroups, 148–149
risk-related considerations for regulatory decisions, 145
the treatment of future generations in CEA, 151–154
Distributional effects, 274–275
Documentation, 70
DOE. See Department of Energy
and number of attribute levels for generic HRQL indexes, 95
Double-counting issues, 30, 62
E
Economic analysis, the role of, 19–26
Economic efficiency, 319–320
Economic regulation, the presumption against, 265
Economic values of uncertain outcomes, 310
“Economically significant” regulations, defining, 24
Effective date, 315
Effectiveness
constructing measures of, 272
selecting integrated measures of, 10–11, 272–273
Effectiveness metric, for public health and safety rulemakings, 272–274
ELS. See Equivalent lives saved
Emission reduction benefits, non-monetized, 303
Empirical validity, 83–85
mean valuations for 13 EQ-5D health states with four estimation methods, 85
the TTO method and discounting, 84
Endpoints, 207
describing, 197–198
Energy impacts, 312–313
Enforcement, 157
different methods for, 266
Environmental impact statements, 312
Environmental Protection Agency (EPA), 43–48, 58, 62, 101, 117, 120, 139, 143, 147–151, 156, 178, 194–199, 202, 228–232, 237–241, 276, 299, 303
New Source Review program, 291
Science Advisory Board, 294–295
violating TSCA, 48
EO. See Executive Orders
EOP. See Executive Office of the President
EPA. See Environmental Protection Agency
EPA analysis, 229–230
EPA estimates of annual quantified benefits, 230
EPA’s morbidity inclusive life year (MILY) approach, 60–61
EQ-5D. See EuroQoL-5D
Equivalent lives saved (ELS), 60, 215–217, 273
Escherichia coli O157:H7, 204–210
Estimates of QALY gains, 207–212, 223–228, 233–237
HRQL with illness at average age of incidence, 235
HRQL with injury, 227
HRQL with pathogen-related illness, 208
QALY total losses, 210, 224, 236
sensitivity analysis for QALY losses, 211, 226, 237
Estimating the Contributions of Lifestyle-Related Factors to Preventable Death, 186
Estimating the Public Health Benefits of Proposed Air Pollution Regulations, 121
Estimation of costs, 62–63
Estimation of “with condition” HRQL, 198–199
approaches for determining “with condition” HRQL, 200
Ethical and nonquantifiable aspects of regulatory decisions
beyond ratios, 130–158
conclusions, 157–158
distributional concerns about risks and regulatory interventions, 144–155
improving regulatory decision making, 155–157
value of a QALY, 134–140
Ethical and other implications of risks and of interventions to address risks, 140–144
dimensions of value affecting the acceptability of risks, 140–143
nonquantifiable impacts, 143
summary, 143–144
Ethical assumptions in QALY-based CEA, 132–134
valuing life years compared with valuing lives, 132–134
Ethically informed decisions, 7–9
EuroQoL-5D (EQ-5D), 6, 18, 72, 79, 83–85, 94, 99–104, 111–112, 119–124, 128, 136, 165–166, 198–204, 214–215, 222–228, 232–234, 238, 252
availability, 101
domains, 100
history, 100
valuation, 100–101
EuroQoL-5D (EQ-5D) health states, mean valuations, with four estimation methods, 85
EVGGFP. See Global health status measure (EVGGFP—excellent, very good, good, fair, poor)
Executive Office of the President (EOP), 16
Executive Orders (EOs), 25
No. 12044—Improving Government Regulations, 22
No. 12291—Federal Regulation, 22
No. 12866—Regulatory Planning and Review, 3, 22–26, 258–262, 266, 275, 278, 310–311
No. 12898—Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, 25
No. 13045—Protection of Children from Environmental Health Risks and Safety Risks, 25, 312
No. 13211, 312–313
No. 13272, 311
Expert assignment of health states, using generic HRQL instruments, 110–111
Externality, common property resource and public good, 262–263
“Extra-welfarists,” 27
F
Fatality risks, 293–296
FCI. See Functional Capacity Index
FDA. See Food and Drug Administration
defined, 44
Federal Insecticide, Fungicide, and Rodenticide Act, 43
Federal Motor Carrier Safety Administration (FMCSA), 46
Federal Register, 20–21
Federal regulatory action
market failure or other social purpose, 262–264
need for, 261–265
the presumption against economic regulation, 265
showing that regulation at the Federal level is the best way to solve the problem, 264–265
“Feeling thermometer,” 79
Firms, different requirements for different sized, 267
FMCSA. See Federal Motor Carrier Safety Administration
Food and Drug Administration (FDA), 46, 53, 57, 114, 117, 151–152, 194, 197, 214, 222, 225–228, 232, 238, 241
analysis by, 204–205
benefit valuation approach of, 59
case study analytic approach, 205–207
cost-effectiveness ratios, 212–215
estimates of annual quantified benefits, 206
estimates of QALY gains, 207–212
juice processing regulation, 194, 204–215
Food Quality Protection Act, 45
Food Safety and Inspection Service (FSIS), 46, 58
Food supply, safeguarding, 1
Ford, Gerald, 22
FSIS. See Food Safety and Inspection Service
Full disclosure, 314
Functional Capacity Index (FCI), 103, 198, 215, 222–226, 254–257
Future generations in CEA, 152–154
discounting and timing of impacts, 153
future effects, 151–152
future generations, 152–154
treatment of, 151–154
G
Generic HRQL indexes, 6, 93–102, 320
domains and number of attribute levels for generic HRQL indexes, 95
the EuroQol-5D, 100–101
Health Utilities Index, 98–99
measuring HRQL with generic instruments—community value, 97
Quality of Well-Being Scale, 97–98
the SF-6D, 101–102
valuation surveys for generic HRQL instruments, 96
Generic indexes, 165–166
characterizing health states with, 166
Geographic regions, different requirements for, 267
Global Burden of Disease, 81
Global health status measure (EVGGFP—excellent, very good, good, fair, poor), 126n
Graham, John, 17
Guidelines relevant to CEA, 62–65
assessing uncertainty and nonquantified effects, 64
communicating the methods and results, 64–65
determining the distribution of impacts, 64
discounting impacts over time, 63
estimating costs, 62–63
using ratios, 64
H
HALYs. See Health-adjusted life years
Harvard Center for Risk Analysis, 120
Harvard School of Public Health (HSPH), 199
Center for Risk Analysis, 117
Health-adjusted life years (HALYs), 2–10, 15–19, 27–28, 32–40, 52–56, 63–91, 122, 135, 159–163, 181, 320
alternative HALY metrics for regulatory CEA, 86–91
describing health states, 74–76
metrics of, 69
valuing health states and preference elicitation methods, 77–86
Health and Retirement Survey 2000, 99
Health and safety rulemakings, 47
Health-based requirements, 42–43
Health benefit values for regulatory analysis
correlations and cross-walks of HRQL measures, 126–127
criteria for selecting HALY metrics for regulatory CEA, 68–72
health-adjusted life years, 73–91
measures and strategies for obtaining, 67–129
research and development of metrics and valuation methodologies, 123–125
single-dimension measures of health-related outcomes, 72–73
sources of health state values for regulatory analysis, 92–123
summary and conclusions, 125–129
Health-benefits-only ratio, 167, 170
Health care policy, effectiveness in, 5
Health-care-treatment-cost impacts, defined, 172
Health effects likely to be quantified in forthcoming major health and safety rulemakings, 48
Health endpoints, describing, 197–198
Health gains, calculation of, 149–151
“Health–health” analysis, 49
Health indexes, 245–257
EuroQoL-5D, 252
Functional Capacity Index, 254–257
Health Utilities Index, 247–251
Quality of Well-Being Scale, 245–246
SF-6D, 253
Health profiling instruments, disease-specific, 103
Health-related effectiveness measures, 5–7
Health-related quality of life (HRQL), 2–16, 34–40, 52–53, 57–62, 67–79, 83–129, 133–137, 148–150, 156, 160–170, 177–189, 195–209, 214–218, 222, 227, 232–241, 273, 320
with illness at average age of incidence, 235
with injury, 227
measurement and regulatory CEA,
conducting research to improve, 13–14
measurement for children, 106–107
measurement quality, 166–167
with pathogen-related illness, 208
Health risks, regulating, 1
Health state index values
and benefits transfer, 116–121
the CEA Registry, 118
defined, 34n
from published sources, 120–121
Health state values for regulatory analysis, 92–123
approaches based on population survey data, 110–116
assignment of health states by experts or other proxies, 106–109
condition-specific indexes and applications to special populations, 102–106
generic HRQL indexes, 93–102
health state index values from prior studies and benefits transfer, 116–121
primary elicitation of condition-specific index values, 92–93
uncertainty in health status and preference measurement, 121–123
changes in, 136
concepts and domains used in defining self-reported health status, quality of life, and health-related quality of life, 76
describing, 74–76
health-adjusted life years, 75
“postregulatory,” 8
Health Utilities Index (HUI), 6, 71, 98–99, 104, 119–120, 124, 165–166, 198, 247–251
availability, 99
domains, 99
history, 98–99
Mark 1 (HUI-1), 99
Mark 2 (HUI-2), 99, 104, 107, 215, 222, 227, 247–248
Mark 3 (HUI-3), 72, 99–100, 120, 124, 202–204, 209, 214, 233, 249–251
valuation, 99
Healthy year equivalent (HYE), 88, 91, 320–321
“Hedonic price equations,” 281
Holistic approach, 97
HRQL. See Health-related quality of life
HRQL valuation, using ordinal data for, 124
HRQL values, 135–139
individual preferences and societal values, 138–139
whose values count, 135–138
HSPH. See Harvard School of Public Health
HUI. See Health Utilities Index
Hybrid requirements, 44–46
HYE. See Healthy year equivalent
I
IADL. See Immediate activities of daily living
ICD. See International Classification of Disease codes
Immediate activities of daily living (IADL), 115n
Impacts
on children, 312
determining the distribution of, 64
on small businesses and other small entities, 310–311
Indirect uses of market data, 284–285
Individual preferences, and societal values, 138–139
Informal caregiver time, 33
Information collection, paperwork, and recordkeeping burdens, 311
Information needed for regulatory decision making, 12–13, 181–184
distributional and other aspects of risk and regulation, 183
inadequate, 263–264
Information quality guidelines, 311–312
Information Quality Law, 311
Informational measures, rather than regulation, 268–269
Injuries, 321
reducing the risk of, 1
to restrained children, 219–221
Institute of Medicine (IOM), 2, 18, 116, 186, 193, 274
Committee on Summary Measures of Population Health, 18
Intangibles, 290
Integrated measures of effectiveness, 10–11, 161–167
characterizing health states with generic indexes, 166
criteria for selecting integrated effectiveness measures for health-related CEA, 162
generic indexes, 165–166
HRQL measurement quality, 166–167
valuation, 164–165
Interagency Working Group on Summary Measures of Population Health, 116
Intergenerational discounting, 301–302
International Classification of Disease (ICD) codes, 113, 233
International Classification of Impairments, Disabilities, and Handicap, 89
Interobserver reliability. See Intrarater test-retest reliability
Intrarater test-retest reliability, 321
of the SG, TTO and visual analogue scale techniques, 82
IOM. See Institute of Medicine
J
Judicial review of regulatory analyses, 47–50
Juice processing. See Food safety
K
KABCO injury categories, 216
Kaldor-Hicks criterion, 31
L
Latency period, 300
“Learning curve” effects, 303
Life expectancy (LE), 87, 115n, 321
Life years (LYs), 8–9, 132–133
gaining, 172
changes in, 5
trading off, 139
LYs. See Life years
M
MAIS. See Maximum Abbreviated Injury Scale
Mapi Research Institute, 102n
Market data, direct and indirect uses of, 283–285
Market failure or other social purpose, 262–264
externality, common property resource and public good, 262–263
inadequate or asymmetric information, 263–264
market power, 263
other social purposes, 264
Market-oriented approaches rather than direct controls, 268
Market power, 263
Maximum Abbreviated Injury Scale (MAIS), 60–61, 216–218, 222
categories used in NHTSA analyses, 58
Maximum Abbreviated Injury Scale 2 (MAIS 2), 225
Medical Expenditure Panel Survey (MEPS), 101–102, 111, 123, 148, 199, 203, 228, 232–237
Methods for treating non-monetized benefits and costs, 290–292
benefits and costs that are difficult to monetize, 291
benefits and costs that are difficult to quantify, 291–292
MILY. See Morbidity-Inclusive Life Year
Monetized emission reduction benefits, 303
Monetized health-adjusted life years in benefit cost analysis, 53
Monetizing benefits and costs, 292–296, 313
fatality risks, 293–296
nonfatal health and safety risks, 292–293
valuation of reductions in health and safety risks to children, 296
Monopoly issues, 263
Monte Carlo simulations, 309, 321
Morbidity, 321
changes in, 5
combining in a single measure with mortality, 139–140
Mortality-based indicators, 5
Motor vehicle accidents, national costs of, 55
Multiple regression analysis, 281
N
National Automotive Sampling System (NASS), 218, 221–223
National Environmental Policy Act (NEPA), 312
National Health Interview Survey (NHIS), 98, 114, 126n, 148
National Highway Traffic Safety Administration (NHTSA), 46, 50–58, 103–104, 147, 194–202, 215–217, 221, 226–227, 232, 238, 241
case study analytic approach, 217–223
child restraints regulation, 194, 215–228
equivalent lives saved (ELS) approach, 60–61
estimates of annual quantified benefits, 218
estimates of QALY gains, 223–228
National Institute on Aging, 124
National Medical Expenditure Survey (NMES), 126n
National Research Council
Board on Environmental Studies and Toxicology, 121
Committee on Estimating the Health-Risk-Reduction Benefits of Proposed Air Pollution Regulations, 18, 185
NEPA. See National Environmental Policy Act
Net benefits, calculation of, 31
Neumann, Peter, 120
New Source Review program, 291
NHIS. See National Health Interview Survey
NHTSA. See National Highway Traffic Safety Administration
Nixon, Richard, 22
NMES. See National Medical Expenditure Survey
“Non-use values,” 284–285
Nonfatal health and safety risks, 292–293
Nonmonetized benefits and costs
of the EPA’s nonroad diesel rule, 179–180, 303
methods for treating, 290–292
Nonquantifiable impacts, 143
Nonquantified effects, assessing, 64
Nonroad diesel rule, 178, 194–195
Nonroad engine air emissions regulation, 228–240
case study analytic approach, 231–233
cost-effectiveness ratios, 237–240
EPA analysis, 229–230
estimates of QALY gains, 233–237
Notice of Proposed Rulemaking, 21
NRDC v. EPA, 44
Nuclear Regulatory Commission, 26
O
Occupational Safety and Health Act of 1970, 42, 45
Occupational Safety and Health Administration (OSHA), 42–43, 46, 58
Office of Information and Regulatory Affairs (OIRA), 17, 315
Statistical and Science Policy Branch, 312
Office of Management and Budget (OMB), 1–4, 16–22, 26, 41, 50–55, 62–65, 93, 108n, 116, 121, 143, 149, 274, 279, 313–315
Circular A-4, 3, 16, 23, 40, 50, 53–56, 62–65, 134, 146, 152–154, 174, 194–196, 217, 258–315
criteria for evaluating stated preference studies, 54
rationale for requiring CEA as part of regulatory analysis, 17
OIRA. See Office of Information and Regulatory Affairs
OMB. See Office of Management and Budget
OSHA. See Occupational Safety and Health Administration
P
Panel on Cost-Effectiveness in Health and Medicine (PCEHM), 18, 32–33, 67, 93, 103–105, 110, 118–119, 122, 125, 128, 149, 172, 241
Particulate matter (PM) emissions, 229
Patient self-assessments, 222
Patient time, 33
PCEHM. See Panel on Cost-Effectiveness in Health and Medicine
Performance standards, rather than design standards, 267
Person trade-off (PTO), 6, 77–81, 89–91, 138–139, 155, 322
Personal control, degree of, 142
PM. See Particulate matter emissions
Population-based, condition-specific HRQL values, 112–113
Population health data, and subgroups, 148–149
Population survey data-based approaches, 110–116
catalogues of chronic condition HRQL values, 111–113
incorporation of health profiles and HRQL questions and instruments in routine population surveys, 114–116
sources for population-based, condition-specific HRQL values, 112–113
statistically inferred HRQL values, 114
“Postregulatory” health status, 8
Precision of estimates, 314
Preference-based indexes, 103, 322
“Preference weights,” 34n
Premature mortality, 72–73
Preventable mortality, 72–73, 211, 322
Primary elicitation of condition-specific index values, 92–93
Probabilistic analysis, of uncertainty, 64
Producer surpluses, 281
Professional judgment, 286
Proposed regulatory actions, need for analysis of, 259–260
PTO. See Person trade-off
Publicity, 157
Published sources, using health state index values from, 120–121
Purpose and scope issues, 193–195
EPA’s nonroad diesel rule, 194–195
FDA’s juice processing rule, 194
NHTSAs child restraint rule, 194
Q
QALDs. See Quality-adjusted life days
QALYs. See Quality-adjusted life years
Qualitative benefits and costs, 313
Quality
defined for benefit transfer studies, 116
Quality-adjusted life days (QALDs), 59, 204
Quality-adjusted life years (QALYs), 4–16, 34–37, 57–62, 68–71, 78–92, 103–105, 109, 117, 122–135, 139–154, 158–185, 193–197, 204–205, 214–217, 224–226, 234–241, 273, 322
gain in defined, 172
Quality of Life Instruments Database, 102n
Quality of Well-Being Scale (QWB), 6, 58–59, 71–72, 97–98, 114, 122, 165–166, 198–204, 212–215, 222–227, 245–246
availability, 98
domains, 98
history, 97–98
self-administered version, 98
valuation, 98
Quantified benefits, 313
EPA estimates of annual, 230
of EPA’s nonroad diesel rule, 56
of the FDA’s juice processing rule, 57
QWB. See Quality of Well-Being Scale
R
Radon exposure levels, 30
RAND Health Insurance Experiment, 101
Rating scale (RS), 85, 90, 119, 322
Ratios
ethical and nonquantifiable aspects of regulatory decisions beyond, 130–158
scale of, 322
using, 64
Rawls, John, 17
Real discount rates, of 3 percent and 7 percent, 298–300
“Real options” methods, 306
Recent regulations
examples of, 46–47
health effects likely to be quantified in forthcoming major health and safety rulemakings, 48
summary of recent major health and safety rulemakings, 47
Recommendations for regulatory cost-effectiveness analysis, 11–14, 159–189
constructing and reporting cost-effectiveness ratios, 167–181
data collection and research needed to improve HRQL measurement and CEA for regulatory decision making, 184–188
information needed for regulatory decision making, 181–184
selecting integrated measures of effectiveness, 161–167
summary, 188–189
Regulations
compliance costs defined, 172
at the Federal level, 264–265
recent, 46–48
summary, 65–66
types of risk regulations, 41–50
Regulatory analysis
choosing a HALY measure for, 91
current practices for, 50–65
key elements of, 260–261
Regulatory Analysis. See Circular A-4
Regulatory decision making, 155–157
enforcement, 157
presenting information needed for, 12–13
publicity, 157
relevance, 157
revisability and appeals, 157
Regulatory development
and economic analysis, 3–4
key requirements of the Administrative Procedure Act, 21
process of, 20–22
requirements for regulatory analysis and decision making, 22–26
the role of economic analysis in, 19–26
Regulatory Flexiblity Act, 267, 310
“Regulatory flexiblity analysis” (RFA), 310–311
Regulatory interventions, 10
“Regulatory Right-to-Know Act,” 26, 258, 275, 278
Relevance, 157
intrarater test-retest reliability of the SG, TTO and visual analogue scale techniques, 82
Reporting cost-effectiveness ratios, 11–12, 167–181
Representativeness issues, 70
Reproducibility of results, 278–279
Requirements for regulatory analysis and decision making, 22–26
definition of “economically significant” regulations, 24
Executive Orders, 25
history of administrative guidance on regulatory analysis, 22
Research and development of metrics and valuation methodologies, 123–125
best practices in stated preference surveys and benefits transfer, 125
correlations and conversions among HRQL measures, 123–124
using ordinal data for HRQL valuation, 124
Resource Conservation and Recovery Act, 43
Resources for the Future, 17
Revealed preference methods, 282–285, 323
direct uses of market data, 283–284
indirect uses of market data, 284–285
Revisability and appeals, 157
RFA. See “Regulatory flexiblity analysis”
RIA, 279
“Risk neutrality,” 310
Risk-related considerations for regulatory decisions, 145
“Risk–risk” analysis, 49
Risks
with delayed effects, 142
dimensions of value affecting the acceptability of, 140–143
personal control over, 142, 145
treatment of, 314
Routine population surveys, incorporation of health profiles and HRQL questions and instruments in, 114–116
RS. See Rating scale
S
SAB. See Science Advisory Board
Safe Drinking Water Act (SDWA), 44–45
Salmonella (non typhi), 204–210
Saved young life equivalent (SAVE), 90–91
Science Advisory Board (SAB), 294–295
SDWA. See Safe Drinking Water Act
Self-reported health status (SRHS), 115n
“Senior discount” controversy, 134
Sensitivity analysis, 156, 225, 308–309, 323
for QALY losses, 211, 226, 237
SF-6D, 6, 71, 75, 94, 101–102, 123–124, 165–166, 198, 204, 214, 253
availability, 102
domains, 101–102
history, 101
valuation, 102
SF-12 data sets, 71, 101–102, 123–124, 165
SF-36 data sets, 71, 75, 101–102, 165
SG. See Standard gamble
“Shadow price” approach, 298
Single-dimension measures of health-related outcomes, 72–73
Small Business Administration, Chief Counsel for Advocacy of, 311
Social purposes, 264
“Social rate of time preference,” 299
Special populations, 104–105
Specialized analytical requirements, 310–313
analysis of unfunded mandates, 311
energy impacts, 312–313
environmental impact statements, 312
impact on small businesses and other small entities, 310–311
impacts on children, 312
information collection, paperwork, and recordkeeping burdens, 311
information quality guidelines, 311–312
SPM. See “Stated preference” methods
SRHS. See Self-reported health status
Standard gamble (SG), 77–78, 80–86, 90, 105–107, 119, 124, 323
Standard performance criteria, for HRQL instruments, 70
“Stated preference” methods (SPM), 30, 285–287, 323
Statistical and Science Policy Branch, 312
Statistically inferred HRQL values, 114
Statutory standards, 42–46
health-based requirements, 42–43
hybrid requirements, 44–46
technology-based requirements, 44
Summarizing Population Health, 116
Supreme Court, 43
“Switch points,” 308
T
Technology-based requirements, 44
Theoretical reliability, 83
“Threshold” analysis, 260
Time preference, 323
for health-related benefits and costs, 300–301
for non-monetized benefits and costs, 302–303
Time trade-off (TTO), 77–90, 100, 105, 114, 119–124, 128, 324
Toxic chemicals, minimizing exposure to, 1
Toxic Substances Control Act (TSCA), 45, 48
Trade-off based methods, 80
for longevity, 139
Transfers, separate reporting of, 314–315
Transparency, 70, 261, 278–279, 314
TSCA. See Toxic Substances Control Act
TTO. See Time trade-off
TTO method and discounting, 84
U
Uncertain outcomes, economic values of, 310
Uncertainty
alternative assumptions, 310
assessing, 64
economic values of uncertain outcomes, 310
in health status and preference measurement, 121–123
probabilistic analysis of, 64
quantitative analysis of, 307–309
Unfunded Mandates Act, 311
U.S. Constitution, 42
U.S. Public Health Service, 32
“Use values,” 284–285
Utility function, 324
Utility-theoretical model, 86
Utility theory, 70
“Utility weights,” 34n
V
Validity, 324
concurrent, 318
convergent, 318
criterion, 319
Valuation, 29–30, 32–36, 70, 98–102, 137n, 164–165, 288–289
contingent, 125
decomposed, 97
of reductions in health and safety risks to children, 296
Valuation surveys, for generic HRQL instruments, 96
Value of a QALY, 134–140
combining morbidity and mortality in a single measure, 139–140
source of HRQL values, 135–139
summary, 140
Value of a statistical life (VSL), 59, 294–295, 324
Value of a statistical life year (VSLY), 59, 295
Valuing Health Outcomes conference, 17
Valuing health states and preference elicitation methods, 77–86
comparisons among elicitation methods, 81–86
direct rating—category rating and visual analogue scales, 79–80
person trade-off, 80–81
standard gamble, 78
time trade-off, 78–79
Valuing life years compared with valuing lives, 132–134
lives, life years (LYs), and quality-adjusted life years (QALYs), 133
the “senior discount” controversy, 134
Visual analogue scale (VAS), 77, 80–85, 100, 107, 324
VSL. See Value of a statistical life
VSLY. See Value of a statistical life year
W
Wage-risk studies, 30n
Water quality, improving, 1
Weitzman, Martin, 302
White House Council on Environmental Quality, 312
Whitman v. American trucking, 41
WHO. See World Health Organization
WHO’s DALY, 89
Willingness to accept (WTA), 29n, 280, 324
Willingness to pay (WTP), 16, 29–30, 34–38, 62, 65, 85, 195, 229, 280, 288, 292, 325
“With condition” HRQL, approaches for determining, 200
“With condition” values, 234
“With injury” values, 223
“With pathogen-related illness,” 215
“Without condition” HRQL, 199–203
comparison to “with condition” values based on expert assignment, 202
comparison to “with condition” values based on patient self-assessments, 202–203, 211
“Without condition” values, 234
“Without pathogen-related illness,” 215
World Health Organization (WHO), 87–89, 126n
Global Burden of Disease, 81
WTA. See Willingness to accept
WTP. See Willingness to pay
Y
Yellowstone National Park, 289
