Industry's role in cancer research: Anticipating regulatory problems

Abstract

The established national policy in the United States requires manufacturers and processors of chemicals to bear the responsibility for testing their products to ensure that they present no unreasonable risk to health or the environment. This article focuses on the problems which arise after the required testing of a chemical is complete, and the test results appear to be positive for carcinogenicity. It identifies the scientific issues common to recent regulatory proceedings concerning suspected chemical carcinogens and proposes to industry a general program of testing and data collection which can aid manufacturers in their efforts to establish the safety of individual chemicals. Responsible federal regulators charged with implementing environmental safety and health statutes will act cautiously in permitting man to be exposed to any chemical which poses a risk of cancer. Their caution will include reliance upon scientific hypotheses and assumptions concerning chemical carcinogenesis, which, until disproven, will play an unnecessarily restrictive role in determining the availability to the American public of useful chemicals. In response, the chemical industry needs well-focused research to provide hard scientific evidence as a solid foundation for balanced decision-making on suspect chemical carcinogens. This article provides a blueprint for such research.