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EDITORIAL

Regulate Risk management, which deals with the effects of hu- man exposure to potential carcinogens, is a topic of great concern to the public, to industry, and to the federal government. Federal agencies have used a wealth of methods to arrive at hundreds of separate decisions either to regulate or not to regulate chemicals suspected of causing cancer in a variety of uses and situations. The result is a mountain of paper in the public domain.

One of the feature articles in this issue, “Cancer risk management, ” integrates a large amount of that infor- mation for the first time in an attempt to define the rationale the government uses to manage risk. What emerges is a fairly consistent picture: More often than not, if a substance is expected to increase the number of cancer cases by more than four in 1O00, federal agen- cies elect to regulate that substance. On the other hand, if a substance is expected to increase the number of cases by less than one in a million, the chemical is rarely regulated.

When cancer-causing effects fall between these two extremes, decision makers conduct cost-effectiveness analyses, which weigh the cost of the regulation against the number of lives it is likely to save. If the cost falls below $2 million per life saved, the substance is regu- lated. Although this does not appear to be an iron-clad formula, the $2-million figure emerges as a fairly con- sistent break point, separating proposed regulations that are deemed too costly from those that are economi- cally justifiable.

The authors arrived at this conclusion after an ex- haustive search of public documents. Curtis Travis, the feature’s primary author, says “If you ask these agen- cies, they won’t tell you how they are making these decisions. . . . Instead of asking them, we looked at what they did.”

There has always been a certain amount of confusion in the public perception of the difference between risk assessment and risk management. Risk management is a broad area that involves choices regulators must make concerning issues of social and economic policy. Risk assessment is the scientific component of risk management, and as such it does not concern itself with matters of social or economic policy. Rather, it is used to determine the best procedures for estimating health

0013936W87/0921-0411$01.50/0 0 1987 American Chemical Society

the risks effects from chemicals, drugs, and food additives. Fac- tual information, including the dose-response relation- ships seen in laboratory studies involving animals, is used to define the likely exposure effects in a popula- tion at large. And although the end point of cancer causation is currently used in many studies, neurologi- cal damage may soon be used in others. Moreover, there are virtually as many methods and criteria for risk assessment as there are agencies: The Food and Drug Administration may use one set in evaluating a given chemical, EPA another, and the Occupational Safety and Health Administration still another before arriving at regulatory decisions.

In 1981, the National Academy of Sciences estab- lished its Committee on Institutional Means for Assess- ment of Risks to Public Health. The committee was formed at the request of Congress and in response to confusion over the risk management-risk assessment dichotomy. In March 1983 it released a report calling for the federal government to establish a uniform method for determining and regulating risk. Clearly, this has not come to pass in any formal way, although Bavis et al. point out that in a sense there has been some consistency all along.

What is more, the word is beginning to get out to the scientific community. Only last month, the Society for Risk Analysis sponsored a course on carcinogenic risk assessment, which convened at the National Academy of Sciences in Washington, D.C. The object was to bring together those who assess and regulate risk to provide an overview of methods, assumptions, and new research in the area. The long-term goal seems to be to synthesize risk management into an integrated endeavor. This is an ambitious goal, but this month’s feature on risk management and the course on risk assessment will be useful in the continuing dialogue on regulating the risks.

Environ. Sci. Technol., Vol. 21, No. 5, 1987 411