Framework for Assessing Risks of Environmental Exposure to Children

The Framework for Children's Health Risk Assessment report can serve as a resource on children's health risk assessment and it addresses the need to provide a comprehensive and consistent framework for considering children in risk assessments at EPA. This framework lays out the process, points to existing published sources for more detailed information on life stage-specific considerations, and includes web links to specific online publications and relevant Agency science policy papers, guidelines and guidance. The document emphasizes the need to take into account the potential exposures to environmental agents during preconception and all stages of development and focuses on the relevant adverse health outcomes that may occur as a result of such exposures. This framework is not an Agency guideline, but rather describes the overall structure and the components considered important for children's health risk assessment. The document describes an approach that includes problem formulation, analysis, and risk characterization, and also builds on Agency experience assessing risk to susceptible populations. The problem formulation step focuses on the life stage-specific nature of the analysis to include scoping and screening level questions for hazard characterization, dose response and exposure assessment. The risk characterization step recognizes the need to consider life stage-specific risks and explicitly describes the uncertainties and variability in the database. It is important to note that within this framework, life stage-specific data gaps are not meant to convey an obligatory increase in uncertainty factor(s) be applied in a given risk assessment, but rather to consider life stage-specific data in order to better characterize the risk to susceptible groups within the population.