The U.S. Environmental Protection Agency (EPA) has issued a draft Framework for Human Health Risk Assessment to Inform Decision Making that aims to formalize and implement planning, scoping and problem formulation in the risk-assessment process. A response to the National Research Council’s 2009 report Science and Decisions: Advancing Risk Assessment, the draft framework seeks to ensure that risk assessments are tailored to the problems and decisions at hand and are useful to decision makers.  

The framework states several general principles, including that risk assessments should (i) be fit for their intended purpose; (ii) “state the purpose, context and scope clearly”; (iii) “be based on exposure scenarios, consistent with the purpose and context”; (iv) “follow an acceptable, overtly logical path employing common sense and sound judgment in applying relevant guidance”; (v) clearly convey “[a]ll steps, key assumptions, limitations and decisions, along with associated rationale”; (vi) consider “the role of scientific peer and public consultation and review”; and (vii) be presented in an understandable and useful form. EPA has requested comments by September 28, 2012, and will later announce an expert peer-review meeting to be convened by an independent contractor in 2012.