Framework for Assessing Health Risk of Environmental Exposure to Children (External Review Draft)

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Report Information

The draft document, Framework For Assessing Health Risks of Environmental Exposure to Children, 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 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. This draft report will be externally peer-reviewed in the next three or four months by an independent panel of experts prior to making the report final.

Major findings and conclusions: The draft 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 also emphasizes the importance of an iterative approach between hazard, dose response, and exposure analyses.

Key science/assessment issues: The draft 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.

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Background

The document describes an approach that includes problem formulation, analysis, and risk characterization, and also builds on Agency experience assessing risk to susceptible populations.

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.
Analysis step - Focuses on a life stage approach to evaluating hazard, dose-response and exposure that is relevant to the scope of the problem identified in problem formulation.
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.

History/Chronology

Jan 2004	The Children Health Risk Assessment (CHRA) Workgroup was formed to collect information related to these documents.
Oct 2004	An Internal Peer Review was conducted on the initial draft documents.
Mar 2005	Briefed the Office of Children's Health Protection (OCHP) children's Federal Advisory Committee Act (FACA). Then presented an overview of the CHRA framework at the Human Health Research Board of Scientific Counselors (BOSC) program review & at the 2005 Society of Toxicology (SOT) Conference.
Jun 2005	Incorporated peer review suggestions into the final report and then presented at the EPA Regional Risk Assessors Meeting & at the EPA 2005 Science Forum.
Nov 2005	Presented an overview of the CHRA framework at the World Health Organization (WHO) 2005 Meeting.
Dec 2005	Presented an overview of the CHRA framework at the Society for Risk Assessment (SRA) meeting.

Next Steps

NCEA is sponsoring an independent external peer review of the draft document. Eastern Research Associates is the contractor coordinating this peer review. Concluding this external peer panel review, the framework will be revised and finalized in late 2006 to be published on the NCEA web site.

Additional Information

EPA is releasing an independent external peer review report on the Draft Framework for Assessing Health Risk of Environmental Exposures to Children. EPA is revising the current draft framework in light of the constructive peer review and public comments received and anticipates finalizing the document within the next 2 months.

Other Sources:

International Life Sciences Institute (ILSI), 2003, Workshop to Develop a Framework for Assessing Risks to Children from Exposures to Environmental Agents. Risk Science Institute, Washington, DC: ILSI Press. Available at: http://rsi.ilsi.org/NR/rdonlyres/1B183267-ADF3-4FEC-9CA2-339DD1482FC2/0/WorkshopReportFinal.pdf

Downloads

This download(s) is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency determination or policy.

A Framework for Assessing Health Risks of Environmental Exposures to Children (Draft) (PDF) (130 pp, 1 MB, about PDF)
External Peer Review Panel Meeting Charge Questions (PDF) (2 pp, 17 KB, about PDF)
External Peer Review Meeting for Draft Framework for Assessing Health Risks of Environmental Exposures to Children June 6-7, 2006 (PDF) (117 pp, 858 KB, about PDF)