A Framework for Assessing Health Risk of Environmental Exposures to Children (Final)
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.
|Jan 2004||The Children Health Risk Assessment (CHRA) Workgroup was formed to collect information related to these documents.|
|Oct 2004||An Internal EPA Peer Review was conducted on the draft document.|
|Mar 2006||EPA released an external review draft of the document for pubic and peer review.|
|May 2006||EPA hosted an external peer review workshop to review the draft document and solicit public comments.|
|Jun 2006||Independent external peer review panel meeting and public comments received.|
|Oct 2006||Final document posted.|
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