Guidelines for Cumulative Risk Assessment Planning and Problem Formulation

EPA’s Guidelines for Cumulative Risk Assessment Planning and Problem Formulation describes the planning and problem formulation steps of cumulative risk assessments (CRAs) and offers considerations for when such assessments might be appropriate. The document provides recommendations to aid in developing a CRA analysis plan, a discussion on data quality objectives, considerations for a conceptual model, and recommendations on participant and stakeholder involvement. The document focuses on this first phase of a cumulative risk assessment. It does not address other elements of the cumulative risk assessment process, including conducting an analysis, risk characterization, risk communication, or risk management. The guidelines update and supersede the 1997 Guidance on CRA Planning and Scoping, build on the 2003 Framework for CRA, and clarify approaches and considerations when planning for a CRA.

 

This final document was prepared by a technical panel composed of EPA senior risk assessors and risk managers, coordinated through EPA’s Risk Assessment Forum. The Risk Assessment Forum promotes agency-wide consensus on risk assessment issues and coordinates development of EPA risk assessment guidelines. Consistent with EPA’s Peer Review Handbook, the document underwent an independent external contractor-led panel peer review in 2021 and public comment in 2023. The document was reviewed by the agency’s Science and Technology Policy Council and approved for release.  

These Guidelines lay the foundation for considering current and anticipated future cumulative risk analytical methods. They provide recommendations to aid EPA risk assessors in developing a CRA analysis plan but do not dictate direction on which analytical methods to use for conducting CRAs. Emphasis is placed on providing a uniform, yet flexible, CRA planning and problem formulation approach at EPA. These guidelines are not prescriptive and do not impose any requirement for use by EPA or any federal, state or Tribal agency. 

U.S. EPA (U.S. Environmental Protection Agency). (2025). Guidelines for Cumulative Risk Assessment Planning and Problem Formulation. (EPA/100/B-24/001). Washington, D.C.: Risk Assessment Forum, U.S. EPA