The Regulatory Perspective on the Role of Toxicology in Protecting the Public Health

Abstract

The role of toxicology as far as regulatory agencies are concerned is to assist in determining the safety of products/substances to which humans and wildlife are exposed. This is accomplished primarily by assessing the adverse effects of these products/substances. In a number of cases, the benefits of the product/substance are balanced against the adverse effects or hazards. Often the stimulus for new guidelines, policies, and regulations is the discovery of a heretofore unknown hazard, or the presumption that a hazard exists for which current methodologies are deemed insufficient or totally lacking. An example of the latter type of stimulus are the so-called, endocrine modulators or disruptors. Research in toxicology also serves as a stimulus for new guidelines, policies and regulations, for example, dietary restriction and transgenic animal models. There is a painstaking process associated with the development of policy by regulatory agencies regardless of which stimulus operates. This process, however, does not meet with success in all instances. One of the major difficulties in establishing new guidelines, policies, and regulations, is that of bringing about a balance between risk and safety. The role of toxicology in providing basic information which is then used to make decisions and bring about this balance is pivotal. Toxicology can be the stimulus for new guidelines, policies, and regulations, i.e., contribute early in the process or it can contribute at a later stage in providing information to substantiate or refute the need for new guidelines, policies, or regulations.