Abstract

Congress has enacted numerous laws in an attempt to protect people from carcinogens. But neither regulators nor oncologists can hope to accomplish this protection via studies in epidemiology. Nor can they hope to accomplish this using unverified models in carcinogenesis bioassays. The only viable hope is to test and utilize models of carcinogenicity that will tell us what we really need to know; i.e., does this substance pose a reasonable risk of carcinogenesis in man? And if so, what is a quantitative estimate of that risk? There is a substantial number of known human carcinogens. Yet, the most elaborate cancer-testing facility in the world continues to operate without the benefit of validating its results using positive controls (known human carcinogens). Without such controls to gauge the potency of the response in the test animal, Congress can pass 10,000 more laws and still the public will remain unprotected.

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