Guidelines for Cumulative Risk Assessment: Planning and Problem Formulation (Public Comment Draft)

Abstract

EPA’s draft document describes the planning and problem formulation steps of cumulative risk assessments (CRAs) and offers guidelines for when such assessments might be appropriate. The document provides recommendations to aid in developing a CRA analysis plan, but they do not provide guidelines on which analytical methods to use for conducting CRA, which would follow completion of the analysis plan. The guidelines are intended for use in conjunction with other EPA guidelines such as the Guidelines and Supplementary Guidance for Assessment of Chemical Mixtures and the Framework for Human Health Risk Assessment to Inform Decision Making.

This draft 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 Agency risk assessment guidelines. Consistent with EPA’s Peer Review Handbook, the document underwent an independent external contractor-led panel peer review in 2021 and is now being released for public comment prior to finalizing the document.

If you are interested in commenting, please access the document in the Downloads section below. Information on submitting public comments is provided in the Federal Register Notice in the Related Links section. Public comments can be submitted electronically to the Public Comment Docket in the Related Links section.
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.

Impact/Purpose

The draft 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. 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.

Citation

U.S. EPA. Guidelines for Cumulative Risk Assessment: Planning and Problem Formulation (Public Comment Draft). U.S. Environmental Protection Agency, Risk Assessment Forum, Washington, DC, 2023.

Date	Description
01- May 2020	EPA conducted an internal peer review for the draft report.
02- Jul 2021	EPA hosted an external peer review for the draft report.
03- Nov 2021	EPA conducted a second internal peer review for the draft report.
04- Nov 2022	EPA conducted a third internal peer review for the draft report.
05- Jun 2023	EPA released the public comment draft of the Guidelines for Cumulative Risk Assessment Planning and Problem Formulation for a 60-day comment period as announced in the Federal Register. [Federal Register Notice Jun 16, 2023]

Additional Information

For technical information on the draft guidelines or information on the public comment period, contact Dr. Lawrence Martin (martin.lawrence@epa.gov) or via phone/voicemail at 202-308-5642.

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.

• Draft Guidelines for Cumulative Risk Assessment: Planning and Problem Formulation (PDF)  (73  pp, 2.0 MB, about PDF)

Related Link(s)

• Learn about the Cumulative Risk Assessment Guidelines

Docket

Comments on the assessment may be submitted and reviewed using the Docket ID EPA-HQ-ORD-2019-0287