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Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate
A past National Research Council (NRC) report (1983) recommended adoption of the concepts and definitions that have been discussed in this report. The NRC committee recognized that throughout a risk assessment, data and basic knowledge will be lacking and risk assessors will be faced with several scientifically plausible options (called inference options by the NRC) for dealing with questions such as those presented above. For example, several scientifically supportable options for dose scaling across species and for high- to low-dose extrapolation will exist, but there will be no ready means to identify those that are clearly best supported. The NRC committee recommended that regulatory agencies in the United States identify the needed inference options in risk assessment and specify, through written risk assessment guidelines, the specific options that will be used for all assessments. Agencies in the United States have identified the specific models to be used to fill gaps in data and knowledge; these have come to be called default options (EPA, 1986).
The use of defaults to fill knowledge and data gaps in risk assessment has the advantage of ensuring consistency in approach (the same defaults are used for each assessment) and minimizing or eliminating case-by-case manipulations of the conduct of risk assessment to meet predetermined risk management objectives. The major disadvantage of the use of defaults is the potential for displacement of scientific judgment by excessively rigid guidelines. A remedy for this disadvantage was also suggested by the NRC committee: Risk assessors should be allowed to replace defaults with alternative factors in specific cases of chemicals for which relevant scientific data are available to support alternatives. The risk assessors’ obligation in such cases is to provide explicit justification for any such departure. Guidelines for risk assessment issued by the U.S. Environmental Protection Agency (EPA, 1986), for example, specifically allow for such departures.
The use of preselected defaults is not the only way to deal with model uncertainties. Another option is to allow risk assessors complete freedom to pursue whatever approaches they judge applicable in specific cases. Because many of the uncertainties cannot be resolved scientifically, case-by-case judgments without some guidance on how to deal with them will lead to difficulties in achieving scientific consensus, and the results of the assessment may not be credible.
Another option for dealing with uncertainties is to allow risk assessors to develop a range of estimates based on application of both defaults and alternative inferences that, in specific cases, have some