Benchmark Dose Software

BMDS Version 3.3 User Guide (Oct 2022)

The BMDS 3.3 User Guide is a thorough revision of the 3.2 User Guide. The guide’s technical and conceptual explanations were comprehensively updated to reflect the latest changes to the underlying model code. The User Guide also includes screenshots and procedures for BMDS Online, which was co-released with the BMDS 3.3 Excel product.

BMDS v3.3 and BMDS Online are applications to facilitate dose-response modeling. BMDS models are accessible via an Excel-based user interface using the latest update of BMDS v3.3 (downloadable) or online via the BMDS Online module. Dose-response modeling is a technique, often used in toxicology and risk assessment, for quantitatively relating exposure (the dose) to a biological outcome (the response). It may be thought of as an elaborate form of regression, which is the statistical technique used to explore or represent the relationship(s) between two (or more) variables. In the dose-response context, the dose term (e.g., mg of chemical per kg body weight per day) is most often viewed as the “cause” of the response (e.g., presence of a tumor or other manifestation of disease or a measure of the weight of some organ that might be susceptible to the toxic effects of the exposure).

The BMDS v3.3 User Guide is a companion document to both the BMDS 3.3 Excel and BMDS Online applications, and provides users with procedural “how-to” information on using either tool to create benchmark dose analyses, generate results, and produce reports. The User Guide also provides detailed explanations of each of the models used for dose-response analysis. This information may be critical to a risk assessor seeking to understand how a specific dose-response analysis result was calculated.

The U.S. Environmental Protection Agency (EPA) Benchmark Dose Software (BMDS) was developed as a tool to facilitate the application of benchmark dose (BMD) methods to EPA hazardous pollutant risk assessments. This user guide provides instruction on how to use BMDS but is not intended to address or replace EPA BMD guidance. However, every attempt has been made to make the software consistent with EPA guidance, including the Risk Assessment Forum (RAF) Benchmark Dose Technical Guidance Document (U.S. EPA, 2012).

The BMDS User Guide has been a feature of BMDS releases since the release of BMDS 2.2 in 2013 and has been updated as new models or features were added/changed to the software.

The User Guide provides primarily two types of information. The first is descriptive and procedural information (the “how”) to orient the new user to the user interface; this information consists of screenshots, step-by-step procedures, and workflow descriptions. The second is conceptual and reference information (the “why”) on the benchmark dose models that the BMDS products implement via the user interface. The User Guide contains detailed descriptions of the mathematical formulas behind the continuous, dichotomous, and nested dichotomous endpoints, along with multi-tumor analysis; a description of the decision logic BMDS uses to recommend models; and descriptions of outputs specific to all model types.

Impact/Purpose

The U.S. Environmental Protection Agency (EPA) Benchmark Dose Software (BMDS) was developed as a tool to facilitate the application of benchmark dose (BMD) methods to EPA hazardous pollutant risk assessments.

Status

This is the final report.

Citation

U.S. EPA. BMDS Version 3.3 User Guide (Oct 2022). U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-21/245, 2022.

History/Chronology

Date Description
01-Oct 2022EPA released the Benchmark Dose Software (BMDS) Version 3.3 User Guide.
02-Aug 2020EPA released the Benchmark Dose Software (BMDS) Version 3.2 User Guide.
03-Nov 2018EPA released the Benchmark Dose Software (BMDS) Version 3.0 User Guide.
04-Nov 2015EPA released the Benchmark Dose Software (BMDS) Version 2.6.0.1 User Guide.

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.