Framework for Human Health Risk Assessment to Inform Decision Making
- Framework for Human Health Risk Assessment to Inform Decision Making (Final) (PDF) (76 pp, 5Mb, About PDF)
- EPA Responses to External Peer Review Report (PDF) (43 pp, 327Kb, About PDF)
- EPA Response to Public Comments (PDF) (7 pp, 58 Kb, About PDF)
- External Peer Review Report (PDF) (43 pp, 239Kb, About PDF)
- Framework External Review Draft (PDF) (85 pp, 1.1 Mb, About PDF)
Federal Register Notice
This document was developed as part of an agencywide program by the EPA's Risk Assessment Forum. The final Framework for Human Health Risk Assessment to Inform Decision Making was released in April 2014. Previously, EPA released a draft document for public comment and external peer review. The document underwent independent peer review in September 2012. The External Peer Review Report is available in the links section to the right. In preparing the final document, EPA considered the public comments submitted to EPA's docket during the public comment period and the comments and recommendations from the external peer reviewers. EPA’s responses to public comments and external peer review are included in the links to the right.
The purpose of the Framework for Human Health Risk Assessment to Inform Decision Making is to describe a Framework for conducting human health risk assessments that are responsive to the needs of decision making processes at the U.S. Environmental Protection Agency. The Framework is intended to foster increased implementation of existing agency guidance for conducting human health risk assessments and improve the utility of risk assessment in the decision making process.
In developing this Framework the recommendations presented in the National Research Council's report Science and Decisions: Advancing Risk Assessment have been taken into consideration. Specifically, this Framework addresses the recommendations that the EPA formalize and implement planning, scoping and problem formulation in the risk assessment process and that the agency adopt a framework to inform decision making.
The Framework highlights the important roles of planning and scoping as well as problem formulation in designing a risk assessment. In accordance with longstanding agency policy, it also emphasizes the importance of scientific review and public involvement. This Framework will enhance the agency's emphasis on the importance of transparency of the human health risk assessment and decision making. This document is not intended to supersede existing agency guidance; rather by citing and discussing existing guidance in the context of the Framework it is intended to foster increased implementation of agency guidance.
The docket for comments on the external review draft is located on the internet at the following address:
Docket ID: EPA-HQ-ORD-2012-0579.