Framework for Metals Risk Assessment
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The Framework for Metals Risk Assessment (PDF), (172 pp, 1.70MB) released on March 8, 2007, outlines key principles about metals and describes how they should be considered in conducting human health and ecological risk assessments. The Framework seeks to advance our understanding of the impact of metals in a consistent manner across the Agency's programs since inorganic metals and metal compounds present unique issues for risk assessors.
This guidance is not a prescriptive manual on how any particular type of assessment should be conducted within EPA, but rather it outlines the key principles when considering metals and offers advice on how these principles can be considered in metals assessments.
The Framework serves as a single, comprehensive, state-of-the-science reference source from which the different programs within the Agency can evaluate their own methods and practices for assessing metals, and revise or update as appropriate. The Framework also provides a basis from which EPA programs can assess the hazards and risks of metals in a manner that is more consistent with the current state-of-the-science of metals and with each other.
For a hard copy of the Framework, please contact EPA's National Service Center for Environmental Publications at 1-800-490-9198.
Given the complexity of issues surrounding metals risk assessment, the Framework took several years to develop. Originally, EPA's Risk Assessment Forum sought consultation from EPA's Science Advisory Board (SAB) on the science issues and principles that need to be addressed in the Framework document. EPA identified and commissioned scientific experts to write detailed papers on these issues: environmental chemistry, exposure, human health effects, ecological effects, bioavailability and bioaccumulation.
The draft Framework was then developed and relied heavily on these papers. To ensure broad input on the Framework, the Risk Assessment Forum engaged in extensive consultation with the scientific community, stakeholders, and intended users, including risk assessors in other federal agencies, in different regions, and in the states. Throughout the development process, the Agency has held stakeholder meetings and made the issue papers open for public comment.
- Framework for Inorganic Metals Risk Assessment (External Review Draft)
- Papers Addressing Scientific Issues in the Risk Assessment of Metals
- Draft Action Plan for the Development of a Framework for Metals Assessment and Guidance for Characterizing and Ranking Metals (External Review Draft)
- Summary Report of the Meeting on Development of a Metals Assessment Framework
Chronology of Events
January 2002 EPA's Science Policy Council tasked an Agency workgroup, under the auspices of EPA's Risk Assessment Forum, with devising a Metals Action Plan (MAP) to establish a process for ensuring the consistent application of scientific principles to metals risk assessment.
September 2002 EPA's Science Advisory Board (SAB) reviewed the Agency's Draft Metals Action Plan, which called for the development of a framework for metals risk assessment. The SAB emphasized the importance of focusing on the unique properties of metals as they relate to environmental chemistry, bioavailability, bioaccumulation, exposure, and toxicity.
December 2002 To inform the considerations of the unique properties of metals, and to engage the external scientific community, the Agency commissioned external experts to lead the development of a series of issue papers.
September 2003 Draft issue papers were made available for public comment. [Public comments on the draft issue papers may be viewed at EPA's Docket by visiting http://www.regulations.gov and searching on Docket Number OAR-2003-0192.]
July 2004 A Peer consultation workshop was held on a draft Framework, followed by interagency review.
September 2004 Papers were finalized by the authors, per consideration of the public comments.
December 2004 Draft Framework made available for public comment. [Public comments on the draft Framework may be viewed at EPA's Docket by visiting http://www.regulations.gov and searching on Docket Number ORD-2004-0017.]
February 2005 SAB held a peer review meeting on the draft Framework and conducted their external peer review.
January 2006 SAB submitted their report to the Administrator (PDF) (95 pp, 600K).
April 2006 Agency response (PDF) (6 pp, 534K) to the SAB on their peer review.
March 2007 Release of final Framework for Metals Risk Assessment.
- News Release
- Fact Sheet
- EPA Science Advisory Board Peer Review Comments (PDF) (95 pp, 600K)
- Agency Response to SAB Peer Review Comments (PDF) (108 pp, 545K)