10.2190/3RTA-83T0-GUFQ-HTME 3RTA83T0GUFQHTME 2 An Example of Decision-Making on Environmental Carcinogens: The Delaney Clause 109 121 20020509 20020509 20020509 20020509 3RTA83T0GUFQHTME.pdf http://baywood.metapress.com/link.asp?target=contribution&id=3RTA83T0GUFQHTME 2 William P. Darby Department of Technology and Human Affairs, Washington University This analysis focuses on the decision-making process of regulating environmental carcinogens as carried out under the Delaney Clause of the Federal Food, Drug, and Cosmetics Act. The study concludes that regulation of environmental carcinogens in this way is unavoidably based upon a relative assessment of risks and benefits, even though the Delaney Clause is commonly believed to preclude such an assessment. The analysis further concludes that by waiting for evidence acceptable to the scientific community before acting, the decision-maker may unknowingly be operating under a relative assessment of risks and benefits not in accord with his or her own perception. U. S. Congress House Committee on Appropriations, Agriculture-Environmental and Consumer Protection Appropriations for 1975, Hearings, 93rd Congress, 2nd Session, Part 8, Food and Drug Administration, Study of the Delaney Clause and Other Anticancer Clauses, U. S. Government Printing Office, 1974. Office of Technology Assessment, U. S. Congress, Cancer Testing Technology and Saccharin, U. S. Government Printing Office, 1977. M. D. Reuber, Preliminary Review of the Carcinogenicity Studies on Saccharin, typescript, September 12, 1977. Saccharin and Its Salts-Proposed Rule and Hearing, <i>Federal Register, 42</i>:13, p. 20000, April 15, 1977. J. J. Gart, The Comparison of Proportions: A Review of Significance Tests, Confidence Intervals and Adjustments for Stratification, <i>Review of the International Statistical Institute, 39</i>, pp. 148-169, 1971. C. W. Dunnett and M. Gent, Significance Testing to Establish Equivalence Between Treatments, With Special Reference to Data in the Form of 2 X 2 Tables, <i>Biometrics, 33</i>, pp. 593-602, December, 1977. R. A. Fisher, The Logic of Inductive Inference, <i>Journal of the Royal Statistical Society, Series A, 98</i>, pp. 93-94, 1935. E. L. Lehmann, <i>Testing Statistical Hypotheses</i>, John Wiley and Sons, Inc., New York, New York, pp. 140-146, 1959. Y. M. M. Bishop, S. E. Fienberg, and P. W. Holland, <i>Discrete Multivariate Analysis: Theory and Practice</i>, The MIT Press, Cambridge, Massachusetts, pp. 364-366, 1975. S. Siegel, <i>Nonparametric Statistics for the Behavioral Sciences</i>, McGraw-Hill Book Company, New York, New York, pp. 95-104, 1956. K. D. Tocher, Extension of the Neyman-Pearson Theory of Tests to Discontinuous Variates, <i>Biometrika, 37</i>, pp. 130-144, 1950.