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BENCHMARK DOSE TECHNICAL GUIDANCE DOCUMENT
[2/27/07] The BMDS software (version 1.4.1) is available for download at http://www.epa.gov/ncea/bmds.htm
The purpose of this project is to provide guidance for the Agency and the outside community on the application of the benchmark dose (BMD) approach in determining the point of departure (POD) for all types of health effects data, whether a linear or nonlinear low dose extrapolation is used.
The U.S. EPA conducts risk assessments for an array of health effects that may result from exposure to environmental agents, and that require an analysis of the relationship between exposure and health-related outcomes. The dose-response assessment is essentially a two-step process, the first being the definition of a point of departure (POD), and the second extrapolation from the POD to low environmentally-relevant exposure levels. The benchmark dose (BMD) approach provides a more quantitative alternative to the first step in the dose-response assessment than the current NOAEL/LOAEL process for noncancer health effects, and is similar to that for determining the POD proposed for cancer endpoints. As the Agency moves toward harmonization of approaches for human health risk assessment, the dichotomy between cancer and noncancer health effects is being replaced by consideration of mode of action and whether the effects of concern are likely to be linear or nonlinear at low doses. Thus, the purpose of this project is to provide guidance for the Agency and the outside community on the application of the BMD approach in determining the POD for all types of health effects data, whether a linear or nonlinear low dose extrapolation is used. A guidance document is being developed under the auspices of EPA's Risk Assessment Forum.
URLs/Downloads:BENCHMARK DOSE TECHNICAL GUIDANCE DOCUMENT (2000) (PDF,96 pp, 1 KB, about PDF)
Response to Comments (PDF,NA pp, 80 KB, about PDF)
SUMMARY REPORT OF THE WORKSHOP TO PEER REVIEW THE BENCHMARK DOSE TECHNICAL GUIDANCE DOCUMENT (PDF,NA pp, 1309 KB, about PDF)
Peer Review Plan (PDF,1 pp, 2 KB, about PDF)
Record Details:Record Type: DOCUMENT
Organization:U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF THE SCIENCE ADVISOR