Epidemiological studies for regulatory agencies.

In regulation of exposures to hazardous environmental agents, epidemiologic evidence is especially important in defining human risk estimates. The process of developing appropriate regulations is complex, however, and depends on many considerations beyond those established to a high degree of scientific certainty. Thus the needs of regulatory agencies are involved in the way epidemiologic data are developed and presented. To coordinate and review common problems associated with preventive and regulatory activities among the federal agencies concerned with regulation, an Interagency Regulatory Liaison Group (IRLG) was established in 1977. Because of difficulties encountered by these agencies or Congressional committees in evaluating epidemiologic evidence, a subcommittee of the IRLG has developed in draft form guidelines for human population studies to be used in public health decision-making. Although these guidelines have attracted much controversy, their aim is to present criteria for design and documentation of epidemiologic studies, without interfering with the initiative of investigators. Some aspects of the IRLG guidelines are discussed. The need for epidemiologic research in providing evidence for regulatory purposes is increasing, but such studies must be well done if they are to be useful.