(IOM, 2001, p. 216). When there is no cautionary language in the DRI report, discretionary fortification might be considered. When caution is expressed as part of the UL discussion for the nutrient in a DRI report, then according to the decision model discretionary fortification would be considered only after more detailed scientific review and modeling or, on a trial basis while more data are collected, similar to the temporary marketing authorization used in Canada (Health Canada, 1999) and the temporary marketing permits used for variation from standardized food in the United States (21 C.F.R. 130.17). If sufficient public heath need is demonstrated, the regulatory agencies may consider other approaches to increase the availability of the nutrient. If the nutrient has a UL, then the next step is to proceed with modeling of the impact of fortification on the appropriate populations.
Step Three. An exposure analysis would be prepared using the appropriate populations. The analysis would include an evaluation of the severity of the adverse effect and whether the effect is observed with food, fortified food, supplements, or dosages designed for pharmacological purposes. If the totality of evidence from the exposure analysis indicates that fortification of a food item poses a significant risk of adverse effects to at least one segment of the population, then discretionary fortification at the proposed level would not be scientifically justified. If the exposure analysis indicates a minimal risk of harm and/or the effects are not noted at the levels proposed to be provided in food and supplements, discretionary fortification might be scientifically justified. In all cases appropriate records of the analyses should be maintained in the event adverse effects occur. If sufficient public health need is demonstrated, other approaches may be considered to increase the availability of the nutrient to the population.
Use of the decision flow diagram presented in Figure 6-1 is necessarily dependent upon many factors, such as the food that is being considered for fortification, the form of the food, the form and amount of the nutrient to be included in the food, and the exposure/ modeling data. Below are four hypothetical examples that illustrate how the approach might be used. These examples are highly abstract because the necessary data specifics are not included.