Elements of chemical risk assessment

Risk assessment is the tool used to evaluate the safety of food and food additives. As noted by the Joint FAO/WHO (Food and Agricultural Organization of the World Health Organization) Expert Committee on Food Additives (JECFA) safety evaluation of food additives is a two-stage process. In the first stage relevant data are collected, including results of studies on experimental animals and, where possible, human observations, including epidemiology studies. In the second stage data are assessed to determine whether a substance is acceptable for its intended use as a food additive. This scientific process determines the possible adverse effects in humans resulting from exposure to a substance.

In 1983, the US National Academy of Science (NAS) issued a report entitled Risk Assessment in the Federal Government: Managing the Process. The report delineated research, risk assessment, and risk management, but emphasized the separation between the scientific exercise of risk assessment, and the policy exercise of risk management (Figure 21.1). The NAS report gave a formalized structure to the risk assessment process. It described four elements: hazard identification (see Section 21.4.1), dose-response assessment (see Section 21.4.2), exposure assessment (see Section 21.4.3), and risk characterization (see Section 21.4.4), with recommendations and examples given for the types of scientific information needed for each element.

Risk assessment was defined as the process of assessing the possible adverse health effects in humans resulting from exposure to substances or other potential hazards. This definition allows ordering of the data, identifying data gaps and uncertainties, assigning priorities, and determining research needs. Based on the information in the risk assessment, a regulatory agency can then develop regulatory options, evaluate the public health, economic, social, and political consequences of the regulatory options, and implement agency decisions and actions. These decisions and actions are the core of the risk management process. The four elements associated with risk assessment (see Figure 21.1) are briefly described in the following sections. The types of information used in health risk assessment are summarized in Table 21.3.


risk assessment

Hazard identification

Dose - response assessment

Exposure assessment

Risk characterization risk management risk management

Evaluation of public health, economic, social, political consequences of regulatory options

Agency decisions and actions

Figure 21.1 Elements of risk assessment and risk management. Reprinted with permission from Risk Assessment in the Federal Government. Copyright 1983, National Academy of Sciences. Courtesy of the National Academy Press, Washington, D.C.

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