FIGURE 1.

Risk assessment model for nutrient toxicity.

whenever estimates of adverse health effects in humans are based on extrapolations of data obtained under dissimilar conditions (for example, from experimental animal studies). Options for dealing with uncertainties are discussed below and in detail in Appendix B.

Steps in the Risk Assessment Process

The organization of risk assessment is based on a model proposed by the NRC (1983, 1994); that model is widely used in public health and regulatory decision making. The steps of risk assessment as applied to nutrients are as follows (see also Figure 1):

  • Step 1. Hazard identification involves the collection, organization, and evaluation of all information pertaining to the adverse effects of a given nutrient. It concludes with a summary of the evidence concerning the capacity of the nutrient to cause one or more types of toxicity in humans.
  • Step 2. Dose-response assessment determines the relationship between nutrient intake (dose) and adverse effect (in terms of incidence and severity). This step concludes with an estimate of the UL—it identifies the highest level of daily nutrient intake that is likely to pose no risk of adverse health effects to almost all individuals in the general population. Different ULs may be developed for various life stage groups.
  • Step 3. Intake assessment evaluates the distribution of usual total daily nutrient intakes among members of the general population.
  • Step 4. Risk characterization summarizes the conclusions from Steps 1 through 3 and evaluates the risk. Generally, the risk is expressed as the fraction


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