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June 16 -- The U.S. Environmental Protection Agency (EPA) is announcing a 60-day public comment period on the draft Cumulative Risk Assessment (CRA) Guidelines for Planning and Problem Formulation. The CRA Guidelines for Planning and Problem Formulation describe steps for the planning and problem formulation of CRAs and offer guidelines for when cumulative risk assessments could be appropriate. Planning defines both the process for conducting the risk assessment and its general scope, while problem formulation identifies major factors considered in a specific assessment to inform its technical approach. The draft CRA Guidelines for Planning and Problem Formulation are not final, and do not represent, and should not be construed to represent, Agency policy or views. Comments must be received on or before August 15, 2023 to be considered by EPA.

The CRA Guidelines for Planning and Problem Formulation focus on this first phase of a cumulative risk assessment. The document does not address other elements of the cumulative risk assessment process, including conducting an analysis, risk characterization, risk communication, or risk management. Public comments focused on the planning and problem formulation phase of a cumulative risk assessment would be most useful.

EPA undertook the development of methods for CRA beginning with the 1997 Guidance on Cumulative Risk Assessment, Part 1, Planning and Scoping. In 2003, EPA published A Framework for Cumulative Risk Assessment. EPA continued to advance CRA methods to support understanding and reducing risks to people in disproportionately impacted communities, in 2008 publishing Concepts, Methods, and Data Sources for Cumulative Health Risk Assessment of Multiple Chemicals, Exposures and Effects. This draft CRA Guidelines for Planning and Problem Formulation build off the 2003 CRA Framework and updates the 1997 CRA Guidance. The draft CRA Guidelines for Planning and Problem Formulation provides methods by which stressors are identified and incorporated into problem formulation and a conceptual model. In June 2021, the draft CRA Guidelines for Planning and Problem Formulation received an independent contractor-led external panel peer review. Subsequent revision has produced the draft CRA Guidelines for Planning and Problem Formulation that is now released for public comment.

Public comment received on the draft CRA Guidelines for Planning and Problem Formulation will be reviewed and considered to be incorporated into or modify text in the final revised draft of the Guidelines. The final draft Guidelines will then undergo internal EPA review and revision, and then be finalized for publication.
 
EPA Risk Assessment: https://www.epa.gov/risk
Draft CRA Guidelines for Planning and Problem Formulation: https://www.epa.gov/​risk/​guidelines-cumulative-risk-assessment-planning-and-problem-formulation
FRN: https://www.federalregister.gov/d/2023-12972

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