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documents regarding possible toxicity and as long as these trials employ appropriate safety monitoring of trial subjects.


The possibility that the methodology used to derive Tolerable Upper Intake Levels (ULs) might be reduced to a mathematical model that could be generically applied to all nutrients was considered. Such a model might have several potential advantages, including ease of application and assurance of consistent treatment of all nutrients. It was concluded, however, that the current state of scientific understanding of toxic phenomena in general, and nutrient toxicity in particular, is insufficient to support the development of such a model. Scientific information about various adverse effects and their relationships to intake levels varies greatly among nutrients and depends on the nature, comprehensiveness, and quality of available data. The uncertainties associated with the unavoidable problem of extrapolating, from the circumstances under which data are developed (e.g., in the laboratory or clinic) to other circumstances (e.g., the healthy population), adds to the complexity.

Given the current state of knowledge, any attempt to capture in a mathematical model all of the information and scientific judgments that must be made to reach conclusions about ULs would not be consistent with contemporary risk assessment practices. Instead, the model for the derivation of ULs consists of a set of scientific factors that always should be considered explicitly. The framework by which these factors are organized is called risk assessment. Risk assessment (NRC, 1983, 1994) is a systematic means of evaluating the probability of occurrence of adverse health effects in humans from excess exposure to an environmental agent (in this case, a nutrient) (FAO/WHO, 1995; Health Canada, 1993). The hallmark of risk assessment is the requirement to be explicit in all of the evaluations and judgments that must be made to document conclusions.


Basic Concepts

Risk assessment is a scientific undertaking having as its objective a characterization of the nature and likelihood of harm resulting from human exposure to agents in the environment. The characteriza-

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