Principles and Methods for the Assessment of Risk from Essential Trace Elements

The risk assessment approach described in this monograph applies only to essential trace elements (ETEs) involved in human health and not to non-essential elements.

The purpose of the work is to provide the scientific principles that support the concept of an "acceptable range of oral intake" (AROI), which uses a "homeostatic model" for determining the range of dietary intakes for ETEs that meet the nutritional requirements of a healthy population and avoid excess intakes.

To facilitate comparisons, AROIs are discussed in relation to other risk assessment approaches.

Although it includes examples, this monograph is not a compendium of assessments on ETEs, nor is it a textbook detailing the scientific basis of risk assessment of the derivation of dietary reference intakes.

Described in the volume is the process of risk assessment which begins with the selection of the database for a particular ETE.

A weight-of-evidence approach is then used for hazard identification, selecting relevant end-point of deficient and excess exposures.

Next, the probability of risk and the severity of various effects are quantified and critical effects are selected. The AROI is then established by balancing end-points of comparable health significance.

At this time, the exposure assessment is conducted. Finally, a risk characterization enumerating the strengths and weaknesses of the databases is performed, integrating the AROI and exposure assessment.