. "3 A Model for the Development of Tolerable Upper Intake Levels." Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline. Washington, DC: The National Academies Press, 1998.
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DRI Dietary Reference Intakes: For Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline
human exposure to agents in the environment. The characterization of risk typically contains both qualitative and quantitative information and includes a discussion of the scientific uncertainties in that information. In the present context the agents of interest are nutrients and the environmental media are food, water, and nonfood sources such as nutrient supplements and pharmacological preparations.
Performing a risk assessment results in a characterization of the relationship between exposure to an agent and the likelihood that adverse health effects will occur in members of exposed populations. Scientific uncertainties are an inherent part of the risk assessment process and are discussed below. Deciding whether the magnitude of exposure is acceptable or tolerable in specific circumstances is not a component of risk assessment; this activity falls within the domain of risk management. Risk management decisions depend on the results of risk assessments but may also involve the public health significance of the risk, the technical feasibility of achieving various degrees of risk control, and the economic and social costs of this control. Because there is no single, scientifically definable distinction between safe and unsafe exposures, risk management necessarily incorporates components of sound, practical decision making that are not addressed by the risk assessment process (NRC, 1983, 1994).
A risk assessment requires that information be organized in rather specific ways but does not require any specific scientific evaluation methods. Rather, risk assessors must evaluate scientific information using what they judge to be appropriate methods; must make explicit the basis for their judgments about the uncertainties in risk estimates; and, when appropriate, must include alternative scientifically plausible interpretations of the available data (NRC, 1994; OTA, 1993).
Risk assessment is subject to two types of scientific uncertainties: those related to data and those associated with inferences that are required when directly applicable data are not available (NRC, 1994). Data uncertainties arise during the evaluation of information obtained from the epidemiological and toxicological studies of nutrient intake levels that are the basis for risk assessments. Examples of inferences include the use of data from experimental animals to estimate responses in humans and the selection of uncertainty factors to estimate inter- and intraspecies variabilities in response to toxic substances. Uncertainties arise whenever estimates of adverse health effects in humans are based on extrapolations of data obtained under dissimilar conditions (e.g., from experimental animal