Science and politics: the possible regulation of cancer promoters.

To address the problems associated with the regulation of tumor promoters, one must recognize that a regulatory agency's actions in the formulation of policy redound from a matrix of political, social and scientific pressures; each affecting the other, and all influencing the final policy outcome. Scientific understanding of the mecha-nism(s) of tumor promotion plays a determinant role in such interaction, for the selection of particular biological tests as surrogates for human response to chemical exposure provides the radical upon which such interaction occurs, industry responding to the legal, regulatory instrument that relies in turn on scientific confidence in required tests. These parties operate within the penumbra cast by political expedients , environmental action groups, and special interest lobbies whose concerns involve the cost of testing, the availability of resources, the consideration of particular chemicals of economic or symbolic value, and other such aspects of regulatory policy or its consequence. In examining the complex development of policy for future regulation of tumor promoters , we must attend first to the legal instrument framing such regulations, assessing probable impact on these various scientific, economic, social and political factors. Potential regulation of most tumor promoters would fall within the regulatory ambit of the U.S. Toxic Substances Control Act of 1976 (TSCA). As with other regulatory acts, the making of public policy, in this case concerning the manufacture and use of chemicals, derives from two major concerns: the attempt to achieve technical analyses of risks and benefits as one base for regulation, and a general judgment of social welfare or public safety as the other. Technical analysis and social judgment entwine at the outset of TSCA, the Congress finding risk of injury to health and environment from chemical exposure (1), and then establishing as United States policy the development of adequate data regarding the effect of chemical substances and mixtures on health and the environment in order to preclude risk of injury by restrictions on manufacture and use. Social judgment, basically a political process, was intended to lie with the Congress, while technical analysis was to lie with the administrator of the regulatory agency. This basic concept has failed due to continued inexactitude of scientific risk assessment , forcing technical assessment processes to become quasi-political, dependent upon convention, upon opinion and to a surprisingly large degree upon social judgment within the agency and from without. The U.S Environmental Protection Agency, however, by its nature-and …