Epidemiology in the regulatory arena.

Received for publication September 11, 2000, and accepted for publication September 10, 2001. Abbreviations: CDC, US Centers for Disease Control and Prevention; EPA, US Environmental Protection Agency; FDA, US Food and Drug Administration; NRC, National Research Council. From the US Environmental Protection Agency, Washington, DC. Correspondence to Dr. Lynn Goldman, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Suite W8511, Baltimore, MD 21205 (e-mail: lgoldman@jhsph.edu). While epidemiologic evidence and, particularly, results of individual studies is often highly controversial, epidemiologic findings often play a significant role in the development of many environmental standards and regulations. This prominence reflects the direct relevance of epidemiologic evidence to public health, which was a focus for new policy initiatives over the first 5 years of the Clinton administration. Federal environmental statutes state that protection of human health is a major goal in ensuring, for example, clean water, clean air, and responsible management of waste. At times in the past, however, there was less focus on public health and greater reliance on projections of theoretical tools, such as modeling and risk assessment as the basis for selecting among policy options. With the implementation of the Government Performance and Results Act of 1993 (1), a government-wide effort began to identify ways for measuring and tracking outcomes of governmental efforts, including those of the US Environmental Protection Agency (EPA) and other regulatory agencies. At the same time, there is increased appreciation of the relevance of epidemiology in the public policy arena (2). A demand for more surveillance and other epidemiologic data can be anticipated. There are numerous other forces that have pushed regulatory agencies in the direction of relying more on epidemiology. Industry has questioned the applicability of animal toxicology data to human health risk and has wanted human data to be used to validate this practice. Public health advocates have pushed regulatory agencies to look beyond cancer and other diseases that are more readily assessed using animal models to include other diseases (e.g., reproductive, neurologic, and respiratory) where epidemiology studies have indicated there may be additional risks. The National Toxicology Program has recently begun to incorporate more epidemiology information into its cancer assessments for the Report on Carcinogens. Epidemiologists and the findings of epidemiologic studies will probably play a more significant role in environmental regulation in the future. This presentation offers the perspective of a physicianepidemiologist on the role of epidemiologic evidence in the regulatory arena. It draws on selected examples and experiences of the author as a basis for general considerations on epidemiology and regulation. While the presentation is thus based around a particular era of one administration, it offers more general lessons concerning epidemiology and policy. It is hoped that these perspectives will help to promote a greater understanding of the policy process among epidemiologists, and how their data are likely to be used (and misused). It is also hoped to promote a greater understanding and appreciation of the need to incorporate epidemiology among risk assessors (who predominantly are toxicologists).