Department of Agriculture food composition databases (Moshfegh, 2002). Thus it is presently difficult to analyze the impact of current discretionary fortification on usual nutrient intakes in the population. However, it is imperative that the contribution of existing fortification practices and dietary supplements to current intakes be understood before regulations are introduced that would dramatically alter these practices Given this situation, the agencies may decide that it important to support the continuation of certain longstanding discretionary fortification practices for the general nutritional well-being of the population.

Severity of the Adverse Effect

GUIDING PRINCIPLE 15. The severity of the adverse effect on which the Tolerable Upper Intake Level (UL) is based should be reviewed when considering discretionary fortification with a nutrient using the conceptual decision approach presented in Figure 6-1.

An important consideration in using the ULs is the heterogeneity of the severity of the adverse effects on which they are based. The definition of a UL includes the phrase “… is likely to pose no risk of adverse health effects …” (IOM, 1997, 1998, 2000b, 2001, 2002a). The DRI reports define the term adverse effect as “… any significant alteration in the structure or function of the human organism (Klaassen et al., 1986) or any impairment of a physiologically important function that could lead to a health effect that is adverse.”5 This definition provides wide latitude in identifying adverse effects. Often the effect identified for a nutrient is the first effect noted, regardless of its severity, which may not be evidenced from the consumption of food, but only from the consumption of nonfood sources or highly fortified food sources. Selected examples of the diversity of adverse effects identified as the basis for ULs for several nutrients are included in Box 6-1. The committee acknowledges that the paucity of direct data and diversity of adverse effects are limitations to the UL concept.

Therefore in evaluating the potential for overexposure to a specific nutrient, it is necessary to carefully consider the basis for esti-


This definition is “… in accordance with the definition set by the joint World Health Organization, Food and Agriculture Organization of the United Nations, and International Atomic Energy Agency (WHO/FAO/IAEA) Expert Consultation on Trace Elements in Human Nutrition and Health (WHO, 1996)” (IOM, 1997, p. 52).

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