federal agencies, including the Environmental Protection Agency, the Food and Drug Administration, the Food Safety Inspection Service, the National Highway Traffic Safety Administration, the Federal Motor Carrier Safety Administration, the Occupational Safety and Health Administration, and the Consumer Product Safety Commission;

  • Public workshop presentations by developers of health-related quality of life (HRQL) survey instruments and indexes, researchers in the fields of HRQL measurement and CEA, federal survey research officials, and ethicists;

  • Three CEA case studies developed by the Committee in collaboration with federal agency staff, based on published regulatory impact analyses for final rules governing air quality, food safety, and children’s car seat restraints; and

  • Reviews of the peer-reviewed literature on the performance of HRQL measures and methods, methodological research on CEA using health-related effectiveness measures, and empirical and theoretical ethical analyses of the use of HRQL indexes and HALYs in CEA.

The Committee’s investigations, analyses, and deliberations led us to the following overarching conclusions:

  • CEA, like benefit–cost analysis (BCA), offers a useful tool for the development and assessment of regulatory interventions to promote human health and safety. Different measures of effectiveness, including single-dimension measures such as life years and integrated metrics that combine estimates of HRQL and longevity such as HALYs, each provide useful and distinctive perspectives on regulatory impacts.

  • As in the case of BCA, the results of CEA for regulatory interventions are not by themselves sufficient for informed regulatory decisions. The results of economic analyses are routinely supplemented with other types of analysis, and with information from the public, to provide a more comprehensive assessment of the advantages and disadvantages of different regulatory strategies. These other sources of information are a necessary part of the decision-making process because it is not possible to quantify all of the impacts of concern.

  • It is feasible to apply CEA to regulatory interventions today, but additional data and improvements in the methods for measuring HRQL would make it more useful and reliable.

  • Federal regulatory agencies analyze disparate data and contemplate widely varying interventions and types of impacts from their actions. They use diverse approaches to value health-related benefits, partly because of these differences in data sources and types of impact, but also for reasons related to institutional history and precedent. Greater consistency in the



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