Framework for Inorganic Metals Risk Assessment (External Review Draft)

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

Risk Assessment Forum

Federal Register Notices

FR Notice: December 20, 2005

Notice

Public comments on this document may be viewed using EPA's https://www.epa.gov/edocket/. Select "search" and key in the Docket Number ORD-2004-0017. Per the December 20, 2004 Federal Register Notice, all comments submitted by Tuesday, January 18, 2005 were provided to the EPA Science Advisory Board for consideration during their review of the draft framework.

The Agency recognizes that inorganic metals and metal compounds present unique issues and the added challenge of addressing the complexity of these issues in a consistent manner across the Agency's programs. The draft Framework for Metals Risk Assessment (Framework) reflects an EPA effort to develop cross-agency internal guidance for assessing metals. The overarching goals of the framework are to outline key metal-specific scientific principles and consistent approaches for conducting metals risk assessment, based on the best currently available science.

Given the complexity of issues surrounding metals risk assessment, EPA commissioned recognized scientific experts to develop papers on key scientific issues related to risk assessment of metals. These issues included environmental chemistry, exposure, human health effects, ecological effects, and bioavailability and bioaccumulation. The draft framework relies heavily on these issue papers. Development of the framework has also involved 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. After peer review deliberation by EPA's Science Advisory Board (SAB) is complete and the framework is finalized, EPA program offices will be in a position to review their current practices against the recommendations of the metals framework and incorporate adjustments as necessary, consistent with the principles of the framework.

Contact: Risk Assessment Forum Staff, 202-564-6483, or risk.forum@epa.gov

Background/Chronology

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.
July 2004 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.
February 2005 SAB held a peer review meeting on the draft framework.

Downloads/Related Links

Section 1: Introduction (Includes Full Table of Contents) (PDF) (36 pp, 403KB, About PDF)
Section 2: Problem Formulation and Metals Principles (PDF) (17 pp, 170KB, About PDF)
Section 3: Metals Risk Assessment Recommendations (PDF) (39 pp, 155KB, About PDF)
Section 4: Metal-Specific Topics and Methods (PDF) (185 pp, 1MB, About PDF)
Glossary (PDF) (7 pp, 55KB, About PDF)
References (PDF) (44 pp, 257KB, About PDF)
Appendix (PDF) (4 pp, 74KB, About PDF)
Peer Review Plan (PDF) (1 page, 3KB,, About PDF)
Full Document (Includes Full Table of Contents, All Sections, Glossary, References and Appendix) (PDF) (334 pp, 2MB, About PDF)
Section 5: Metals Research Needs (PDF) (12 pp, 75KB, About PDF)

Related Link(s)

Papers Addressing Scientific Issues in the Risk Assessment of Metals

Citation

Framework for Inorganic Metals Risk Assessment (External Review Draft). U.S. Environmental Protection Agency, Washington, D.C., EPA/630/P-04/068B, 2004.