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Benchmark Dose Technical Guidance

Risk Assessment Forum
Federal Register Notices

Federal Register Notice (PDF) (2 pp, 27 KB, About PDF)

Benchmark Dose Technical Guidance

EPA has published the final version of the Benchmark Dose Technical Guidance (PDF) (97 pp, 811K, About PDF) for the purpose of updating risk assessment methodologies. This document provides guidance to risk assessors who intend to use the benchmark dose (BMD) method for developing dose response values and determining a point of departure for toxicological studies. This document is not intended to be specific to EPA’s BMD software but rather generally applicable to any software capable of conducting BMD analysis.

Background
Dose-response analysis is one of the four components of a chemical risk assessment as defined by the National Research Council. Historically, for cancer assessments EPA assessors have used linear methods to determine a dose response while noncancer assessments have relied on identifying the dose at which no adverse effects are detected. As EPA moves toward harmonization of approaches for cancer and noncancer 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.

This guidance document addresses the computation of the BMDs and benchmark concentrations and their confidence limits; data requirements; dose-response analysis, and recommendations for reporting the results.

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