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Steps in the Development of the Tolerable Upper Intake Level
Pages 14-19

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From page 14...
... adverse effects. Observational studies that focus on well-def~ned populations with clear exposures to a range of nutrient intake levels are useful for establishing a relationship between exposure and effect.
From page 15...
... . Key issues that are addressed in the data evaluation of human and animal studies are the following: · Evidence of adverse effects in humans.
From page 16...
... Data derived from studies involving parenteral, inhalation, or dermal routes of exposure may be considered relevant if the adverse effects are systemic and data are available to permit interroute extrapolation. Duration of exposure.
From page 17...
... · Identification of distinct and highly sensitive subpopulations. The ULs are based on protecting the most sensitive members of the general population from adverse effects of high nutrient intake.
From page 18...
... · The critical data set documents the route of exposure and the magnitude and duration of the intake. Furthermore, the critical data set documents the intake that does not produce adverse effects (the NOAEL)
From page 19...
... Since data are generally available regarding intakes of nutrients and food components in human populations, the data on nutrient toxicity may not be subject to the same uncertainties as with nonessential chemical agents, resulting in UFs for nutrients and food components typically less than 10. They are lower with higher quality data and when the adverse effects are extremely mild and reversible.

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