National Research Council. "3 A Model for the Development of Tolerable Upper Intake Levels." Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Washington, DC: The National Academies Press, 2001. 1. Print.
The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc
of daily nutrient intake that is likely to pose no risk of adverse health effects for 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 for members of the general population. In cases where the UL pertains only to supplement use and does not pertain to usual food intakes of the nutrient, the assessment is directed at supplement intakes only. It does not depend on step 1 or 2.
Step 4. Risk characterization summarizes the conclusions from steps 1 and 2 with step 3 to determine the risk. The risk is generally expressed as the fraction of the exposed population, if any, having nutrient intakes (step 3) in excess of the estimated UL (steps 1 and 2). If possible, 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.
Thresholds
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 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, approaches used for carcinogenic risk assessment are 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 protect some specified fraction of the population. The method for identifying thresholds for a general population described here 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)
