The hormesis concept and risk assessment: are there unique ethical and policy considerations?

The hormesis concept holds that low doses of toxic substances and radiation elicit modest biological responses opposite to those caused by higher doses of the same agents. This concept stands in contrast to the prevailing views that a threshold model predicts most responses to toxicants at low doses and that linear extrapolation best predicts mutagenic and carcinogenic responses. Beyond the scientific considerations, there has been concern that inclusion of the hormesis model in risk assessment would raise complex ethical questions, pose serious challenges for policy makers, and threaten public safety. This article briefly reviews the growing evidence for hormesis and offers a perspective on the related ethical and societal issues. Complexities stem from the nature of biphasic curves, in which biological responses fall both above and below background levels. The monotonic responses of the threshold and linear models lend themselves to a single policy objective--avoiding harm associated with exposures. The biphasic responses of the hormesis model, however, suggest the possibility of accruing benefit as well as avoiding harm. The prospect of applying the hormesis model to public health policy is impeded by insufficient ability to identify the hormetic and toxic zones with precision. Moreover, heterogeneity among individuals in susceptibility to toxicants suggests that benefit and risk may be distributed unequally in the population. The potential shift in policy objectives associated with hormesis is considered relative to the difficulty of balancing the ethical principles of nonmaleficence and beneficence while maintaining a higher priority on the former.