Abstract
The approach to assessing the risk to infants and children has been one of the key issues in risk assessment over the last decade. Occasional reports of unexpected adverse effects in these younger subpopulations from the exposure to pharmaceutical agents or environmental chemicals has heightened the awareness that the risk to the younger subpopulations can differ substantially from those to the adults. The need for a special approach to account for the unique characteristics of the younger subpopulations in risk assessment was clearly outlined in a joint report by the International Programme on Chemical Safety (IPCS) and the Commission of the European Communities (CEC) (World Health Organization, 1986). The similarities and differences between children and adults were further documented in a conference sponsored by the International Life Sciences Institute (ILSI) and US Environmental Protection Agency (USEPA) (Guzelian et al., 1992).
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