US EPA

EPA released the final report entitled, A Framework for Assessing Health Risk of Environmental Exposures to Children, which examines the impact of potential exposures during developmental lifestages and subsequent lifestages, while emphasizing the iterative nature of the analysis phase with a multidisciplinary team.

Major findings and conclusions: This report outlines the framework in which mode of action(s) (MOA) can be considered across life stages. The framework is based upon existing approaches adopted in the Framework on Cumulative Risk Assessment and identifies existing guidance, guidelines and policy papers that relate to children's health risk assessment. It emphasizes the importance of an iterative approach between hazard, dose response, and exposure analyses. In addition, it includes discussion of principles for weight of evidence consideration across life stages for the hazard characterization database.

Key science/assessment issues:This framework addresses the questions of why and how an improved children's health risk assessment will strengthen the overall risk assessment process across the Agency. This approach improves the scientific explanation of children's risk and will add value by: 1) providing for a more complete evaluation of the potential for vulnerability at different life stages, including a focus on the underlying biological events and critical developmental periods for incorporating MOA considerations; 2) evaluating of the potential for toxicity after exposure during all developmental life stages; and 3) integrating of adverse health effects and exposure information across life stages.

The Framework document 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 lifestage-specific considerations, and includes web links to specific on-line 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. The document describes an approach that includes problem formulation, analysis, and risk characterization steps, and also builds on Agency experience assessing risk to susceptible groups within the population.

• Problem formulation- Focuses on the lifestage-specific nature of the analysis to include scoping and screening level questions for the analysis phase.
• Analysis- Focuses on a lifestage-specific approach to evaluating hazard, dose-response and exposure that is relevant to the scope of the problem identified in problem formulation.
• Risk characterization- Recognizes the need to consider lifestage-specific risks and explicitly describes the uncertainties and variability in the database.

It is important to note that within this framework, lifestage-specific data gaps are not meant to convey that an obligatory increase in uncertainty factor(s) be applied in a given risk assessment, but rather to consider lifestage-specific data in order to better characterize the risk to susceptible groups within the population.

EPA has released a final report entitled, A Framework for Assessing Health Risk of Environmental Exposures to Children, as announced in the October 13, 2006 Federal Register Notice. This Framework examines the impact of potential exposures during developmental lifestages and subsequent lifestages, while emphasizing the iterative nature of the analysis phase with a multidisciplinary team.

U.S. EPA. A Framework For Assessing Health Risk of Environmental Exposures To Children (2006, Final). U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-05/093F, 2006.