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Title: Introduction to benchmark dose methods and U.S. EPA's benchmark dose software (BMDS) version 2.1.1

Abstract

Traditionally, the No-Observed-Adverse-Effect-Level (NOAEL) approach has been used to determine the point of departure (POD) from animal toxicology data for use in human health risk assessments. However, this approach is subject to substantial limitations that have been well defined, such as strict dependence on the dose selection, dose spacing, and sample size of the study from which the critical effect has been identified. Also, the NOAEL approach fails to take into consideration the shape of the dose-response curve and other related information. The benchmark dose (BMD) method, originally proposed as an alternative to the NOAEL methodology in the 1980s, addresses many of the limitations of the NOAEL method. It is less dependent on dose selection and spacing, and it takes into account the shape of the dose-response curve. In addition, the estimation of a BMD 95% lower bound confidence limit (BMDL) results in a POD that appropriately accounts for study quality (i.e., sample size). With the recent advent of user-friendly BMD software programs, including the U.S. Environmental Protection Agency's (U.S. EPA) Benchmark Dose Software (BMDS), BMD has become the method of choice for many health organizations world-wide. This paper discusses the BMD methods and corresponding software (i.e., BMDS version 2.1.1)more » that have been developed by the U.S. EPA, and includes a comparison with recently released European Food Safety Authority (EFSA) BMD guidance.« less

Authors:
 [1];  [1];  [2]
  1. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Research Triangle Park, NC 27711 (United States)
  2. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Cincinnati, OH 45268 (United States)
Publication Date:
OSTI Identifier:
21587793
Resource Type:
Journal Article
Journal Name:
Toxicology and Applied Pharmacology
Additional Journal Information:
Journal Volume: 254; Journal Issue: 2; Conference: TRAC 2008/2009 meeting: 2008 Toxicology and Risk Assessment Conference;2009 Toxicology and Risk Assessment Conference, West Chester, OH (United States);West Chester, OH (United States), 14-17 Apr 2008;27-30 Apr 2009; Other Information: DOI: 10.1016/j.taap.2010.10.016; PII: S0041-008X(10)00409-6; Copyright (c) 2010 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA); Journal ID: ISSN 0041-008X
Country of Publication:
United States
Language:
English
Subject:
60 APPLIED LIFE SCIENCES; ANIMALS; BENCHMARKS; COMPARATIVE EVALUATIONS; COMPUTER CODES; DOSES; PUBLIC HEALTH; RISK ASSESSMENT; SAFETY; US EPA; EVALUATION; NATIONAL ORGANIZATIONS; POLLUTION CONTROL AGENCIES; US ORGANIZATIONS

Citation Formats

Davis, J. Allen, E-mail: davis.allen@epa.gov, Gift, Jeffrey S., and Zhao, Q. Jay. Introduction to benchmark dose methods and U.S. EPA's benchmark dose software (BMDS) version 2.1.1. United States: N. p., 2011. Web. doi:10.1016/j.taap.2010.10.016.
Davis, J. Allen, E-mail: davis.allen@epa.gov, Gift, Jeffrey S., & Zhao, Q. Jay. Introduction to benchmark dose methods and U.S. EPA's benchmark dose software (BMDS) version 2.1.1. United States. doi:10.1016/j.taap.2010.10.016.
Davis, J. Allen, E-mail: davis.allen@epa.gov, Gift, Jeffrey S., and Zhao, Q. Jay. Fri . "Introduction to benchmark dose methods and U.S. EPA's benchmark dose software (BMDS) version 2.1.1". United States. doi:10.1016/j.taap.2010.10.016.
@article{osti_21587793,
title = {Introduction to benchmark dose methods and U.S. EPA's benchmark dose software (BMDS) version 2.1.1},
author = {Davis, J. Allen, E-mail: davis.allen@epa.gov and Gift, Jeffrey S. and Zhao, Q. Jay},
abstractNote = {Traditionally, the No-Observed-Adverse-Effect-Level (NOAEL) approach has been used to determine the point of departure (POD) from animal toxicology data for use in human health risk assessments. However, this approach is subject to substantial limitations that have been well defined, such as strict dependence on the dose selection, dose spacing, and sample size of the study from which the critical effect has been identified. Also, the NOAEL approach fails to take into consideration the shape of the dose-response curve and other related information. The benchmark dose (BMD) method, originally proposed as an alternative to the NOAEL methodology in the 1980s, addresses many of the limitations of the NOAEL method. It is less dependent on dose selection and spacing, and it takes into account the shape of the dose-response curve. In addition, the estimation of a BMD 95% lower bound confidence limit (BMDL) results in a POD that appropriately accounts for study quality (i.e., sample size). With the recent advent of user-friendly BMD software programs, including the U.S. Environmental Protection Agency's (U.S. EPA) Benchmark Dose Software (BMDS), BMD has become the method of choice for many health organizations world-wide. This paper discusses the BMD methods and corresponding software (i.e., BMDS version 2.1.1) that have been developed by the U.S. EPA, and includes a comparison with recently released European Food Safety Authority (EFSA) BMD guidance.},
doi = {10.1016/j.taap.2010.10.016},
journal = {Toxicology and Applied Pharmacology},
issn = {0041-008X},
number = 2,
volume = 254,
place = {United States},
year = {2011},
month = {7}
}