Benchmark Dose (BMDS) Technical Guidance Document (Final, 2012)
This document provides technical guidance on the use of the benchmark dose approach for application in quantitative health risk assessment. The benchmark dose approach involves dose-response modeling of the observable data to obtain "benchmark doses" (BMDs), i.e., dose levels corresponding to specific response levels. These BMDs (or their lower confidence limits) can then serve as possible points of departure for linear or nonlinear extrapolation of health effects data and/or as bases for comparison of dose-response results across studies/chemicals/endpoints.
The BMD approach, when practicable, is an improvement on the NOAEL/LOAEL approach for a number of reasons, including the following: 1) BMDs are not restricted to being dose levels used in the experiment, 2) BMD modeling makes better use of all the dose-response data, and 3) BMDs can be based on standardized response levels. This guidance document discusses data evaluation and minimum data requirements for BMD modeling; selection of the benchmark response; modeling the dose-response data, for both quantal and continuous data; computation of BMDs and their lower confidence limits; assessing model fit and comparing across models; and reporting requirements. The document also includes an appendix with examples illustrating various aspects of BMD modeling.
The BMD approach, when practicable, is an improvement on the NOAEL/LOAEL approach for a number of reasons, including the following: 1) BMDs are not restricted to being dose levels used in the experiment, 2) BMD modeling makes better use of all the dose-response data, and 3) BMDs can be based on standardized response levels. This guidance document discusses data evaluation and minimum data requirements for BMD modeling; selection of the benchmark response; modeling the dose-response data, for both quantal and continuous data; computation of BMDs and their lower confidence limits; assessing model fit and comparing across models; and reporting requirements. The document also includes an appendix with examples illustrating various aspects of BMD modeling.
Citation
U.S. EPA. Benchmark Dose (BMDS) Technical Guidance Document (Final, 2012). U.S. Environmental Protection Agency, Washington, DC, EPA/100/R-12/001.
This document has been reviewed in accordance with U.S. Environmental Protection Agency policy and approved for publication. Mention of trade names or commercial products does not constitute endorsement or recommendation for use.