FIGURE 3-2 Theoretical description of health effects of a nutrient as a function of level of intake. The Tolerable Upper Intake Level (UL) is the highest level of daily nutrient intake that is likely to pose no risks of adverse health effects for almost all individuals in the general population. At intakes above the UL, the risk of adverse effects increases.

the observed data to the general population (see Appendix K). Applying a UF to a NOAEL (or LOAEL) results in a value for the derived UL that is less than the experimentally derived NOAEL, unless the UF is 1.0. The greater the uncertainty, the larger the UF and the smaller the resulting UL. This is consistent with the ultimate goal of the risk assessment: to provide an estimate of a level of intake that will protect the health of virtually all members of the healthy population (Mertz et al., 1994).

Although several reports describe the underlying basis for UFs (Dourson and Stara, 1983; Zielhuis and van der Kreek, 1979), the strength of the evidence supporting the use of a specific UF will vary. Because the imprecision of these UFs is a major limitation of risk assessment approaches, considerable leeway must be allowed for the application of scientific judgment in making the final determination. Because data are generally available regarding intakes of nutrients in human populations, the data on nutrient toxicity may not be subject to the same uncertainties as are data on nonessential chemical agents. The resulting UFs for nutrients and food components are typically less than the factors of 10 often applied to nonessential toxic substances. The UFs are lower with higher quality data and when the adverse effects are extremely mild and reversible.

In general, when determining a UF, the following potential