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of the exposed population, if any, having nutrient intakes (Step 3) in excess of the estimated UL (Steps 1 and 2). If possible, scientific characterization also covers the magnitude of any such excesses. Scientific uncertainties associated with both the UL and the intake estimates are described so that risk managers understand the degree of scientific confidence they can place in the risk assessment.
The risk assessment contains no discussion of recommendations for reducing risk; these are the focus of risk management.
A principal feature of the risk assessment process for noncarcinogens is the long-standing acceptance that no risk of adverse effects is expected unless a threshold dose (or intake) is exceeded. The adverse effects that may be caused by a nutrient or food component almost certainly occur only when the threshold dose is exceeded (NRC, 1994; WHO, 1996). The critical issues concern the methods used to identify the approximate threshold of toxicity for a large and diverse human population. Because most nutrients are not considered to be carcinogenic in humans, the approach to carcinogenic risk assessment (EPA, 1996) is not discussed here.
Thresholds vary among members of the general population (NRC, 1994). For any given adverse effect, if the distribution of thresholds in the population could be quantitatively identified, it would be possible to establish ULs by defining some point in the lower tail of the distribution of thresholds that would be protective for some specified fraction of the population. However, data are not sufficient to allow identification of the distribution of thresholds for all but a few, well-studied nutrients and compounds found in food (for example, acute toxic effects or for chemicals such as lead, where the human database is very large). The method described here for identifying thresholds for a general population is designed to ensure that almost all members of the population will be protected, but it is not based on an analysis of the theoretical (but practically unattainable) distribution of thresholds. By using the model to derive the threshold, however, there is considerable confidence that the threshold, which becomes the UL for nutrients or food components, lies very near the low end of the theoretical distribution, and is the end representing the most sensitive members of the population. For some nutrients, there may be subpopulations that are not included in the general distribution because of extreme or distinct vulnerabilities to toxicity. Such distinct groups, whose conditions warrant medical supervision, may not be protected by the UL.
The Joint FAO/WHO Expert Commission on Food Additives and various national regulatory bodies have identified factors (called uncertainty factors [UFs]) that account for interspecies and intraspecies differences in response to