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GUEST EDITORIAL
De minimis risk: Progress and paradox Those professionals involved in environmental risk regulation spend an enormous amount of time and energy on issues of de minimis risk-situations in which substances have been found or are suspected of being carcinogenic at high-dose levels in laboratory animals but, as encountered in air, water, food, and other environmental media, are estimated to pose extremely small risks (such as an upper-bound risk of less than one in one million over the lifetime of the exposed population). What, if any, regulatory action is justified to reduce or eliminate such risks? At what cost? Under what circumstances? Increasingly, public health officials are recognizing “safe” levels of exposure to animal carcinogens and concluding that de minimis risk can be tolerated in some situations. In one sense, the current focus on de minimis risk is a sign of progress. Issues of de minimis risk come to the fore only as our scientific tools are sharpened (especially in toxicology and analytical chemistry) and we progress on the larger issues of environmental risk regulation. Paradoxically, many in the public, the media, and organized interest groups depict the recognition and tolerance of de minimis risk as a sign not of progress but of retreat. The societal goal, they contend, should be to eliminate all exposure to substances found to be carcinogenic in animal studies. Nothing less will do. A further paradox of the current situation is that the zero-risk goal written into some of our regulatory statutes-such as the Delaney clause in the federal Food, Drug, and Cosmetic Act-can actually impede, rather than advance, progress toward risk reduction. This was documented last May with respect to pesticides in a National Academy of Sciences report titled Regulating Pesticides in Food-the Delaney Paradox. There are other areas, notably the regulation of hazardous air pollutants under the Clean Air Act, in which an apparent zero-risk statutory goal has helped stymie progress toward reducing risk. M)13936W8710921.1027$01.SO10 0 1987 American Chemical Society
What can be done to resolve these paradoxes? Unfortunately, public perception and tolerance of risk remains a poorly understood, extremely complex social phenomenon that is not subject to rapid change. For better or for worse, our environmental laws fairly reflect the public’s current gut-level attitude toward environmental risks assumed involuntarily. It is futile to hope for overnight changes in the public’s attitude toward such risks or in our basic environmental statutes. We should instead pursue evolutionary progress toward the consistent, realistic exercise of judgment about environmental carcinogens. This progress can be made by providing regulatory agencies with the resources needed to make good decisions; conducting research to improve the scientific basis for risk assessment and other elements of the decision-making process; supporting the agencies when they make good decisions; and offering constructive criticism when deserved. We also must work to educate the public and our elected representatives. The environmental laws of the 1970s eventually must be updated if they are to function adequately in the 1990s. In our democracy this decision rests not with the experts but with the people. We must speak intelligently to the public so that people can act responsibly for themselves.
Michael R. Taylor is a legal partner in King & Spalding. Washington. D. C., who specializes in food, drug, pesticide, and related health and safefy regulatoq issues. He served on the NASINRC committee that reported last May on Regulating Pesticides in Food. Environ. Sci. Technal.. Vol. 21. No. 11. 1987 1027
