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The Red Book in Context: Science at the Center

A national focus on carcinogen risk assessment grew out of the expectations for zero risk inspired by the strong environmental movement of the early 1970s. With the U.S. Environmental Protection Agency (EPA) in its infancy, the enthusiasm of the movement inspired zero risk expectation and served to underscore the fear that an epidemic of cancer existed and was closely linked, if not substantially caused, by exposure to contaminants in the environment. Founded in 1970, EPA fostered a zero risk policy until it became evident in the mid-1970s that such a policy was unobtainable. The then-Administrator, Russell Train, announced a new procedure on May 15, 1976, which emphasized a two-part process, risk assessment followed by the regulatory decision process, for making policy decisions regarding carcinogens. After 8 years of wholesale application of the two-step process for scores of agents at EPA, the National Research Council's (NRC's) report Risk Assessment in the Federal Government: Managing the Process, called the “Red Book,” gave validity to the approach, codified terminology, and emphasized the central role of science as discrete from the regulatory process which necessarily includes policy, economic and social factors as well as political considerations. The emphasis on the need to preserve the integrity of the scientific process has continuing application 20 years later as there is increasing evidence of the tensions created at the confluence of science and regulatory policy. This paper places the Red Book in the context of history and points to its utility for the present and the future.