Review of EPA’s Updated Problem
Formulation and Protocol for the
Inorganic Arsenic IRIS Assessment
Committee to Evaluate the IRIS Protocol for Inorganic Arsenic
Board on Environmental Studies and Toxicology
Division on Earth and Life Studies
A Consensus Study Report of
THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu
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This activity was supported by a contract (EP-C-14-005, TO#23) between the National Academy of Sciences and the U.S. Environmental Protection Agency. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
International Standard Book Number-13: 978-0-309-49699-5
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Digital Object Identifier: https://doi.org/10.17226/25558
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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2019. Review of EPA’s Updated Problem Formulation and Protocol for the Inorganic Arsenic IRIS Assessment. Washington, DC: The National Academies Press. https://doi.org/10.17226/25558.
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COMMITTEE TO EVALUATE THE IRIS PROTOCOL FOR INORGANIC ARSENIC
Members
Aaron Barchowsky (Chair), University of Pittsburgh, PA
Hugh A. Barton, Consultant, Mystic, CT
Jay I. Goodman, Michigan State University, East Lansing
Margaret R. Karagas, Dartmouth College, Hanover, NH
Ana Navas-Acien, Columbia University, New York, NY
Michael L. Pennell, The Ohio State University, Columbus
Karen A. Robinson, Johns Hopkins University, Baltimore, MD
J. Christopher States, University of Louisville, KY
Daniele Wikoff, ToxStrategies, Inc., Asheville, NC
Carol S. Wood, Oak Ridge National Laboratory, Oak Ridge, TN
Robert O. Wright, Icahn School of Medicine at Mount Sinai, New York, NY
Staff
Susan N.J. Martel, Senior Program Officer
Tamara Dawson, Program Associate
Sponsor
U.S. Environmental Protection Agency
BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY
Members
William H. Farland (Chair), Colorado State University, Fort Collins
Lesa Aylward, Summit Toxicology, LLP, Falls Church, VA
Ann M. Bartuska, Resources for the Future, Washington, DC
Richard A. Becker, American Chemistry Council, Washington, DC
E. William Colglazier, American Association for the Advancement of Science, Washington, DC
Dominic M. DiToro, University of Delaware, Newark
David C. Dorman, North Carolina State University, Raleigh
George Gray, The George Washington University, Washington, DC
R. Jeffrey Lewis, ExxonMobil Biomedical Sciences, Inc., Annandale, NJ
Germaine M. Buck Louis, George Mason University, Fairfax, VA
Reza J. Rasoulpour, Dow AgroSciences, Indianapolis, IN
Joan B. Rose, Michigan State University, East Lansing
Gina M. Solomon, Public Health Institute, Oakland, CA
Deborah L. Swackhamer, University of Minnesota, St. Paul
Joshua Tewksbury, Future Earth, Boulder, CO
Peter S. Thorne, The University of Iowa, Iowa City
Staff
Clifford Duke, Director
Raymond A. Wassel, Scholar and Director of Environmental Studies
Susan N.J. Martel, Senior Program Officer for Toxicology
Laura Llanos, Financial Associate
Tamara Dawson, Program Associate
Acknowledgments
This Consensus Study Report was reviewed in draft form by persons chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets institutional standards of quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process.
We thank the following for their review of this report:
A. John Bailer, Miami University
Gary Ginsberg, New York State Department of Health
Koren Mann, McGill University
Keeve Nachman, Johns Hopkins Bloomberg School of Public Health
Kirk Smith, University of California, Berkeley
Joyce Tsuji, Exponent
Michael Waalkes, National Institute of Environmental Health Sciences (retired)
Paul Whaley, Lancaster University
Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report, nor did they see the final draft before its release. The review of the report was overseen by Robert Hiatt, University of California, San Francisco, and Martin Philbert, University of Michigan, who were responsible for making certain that an independent examination of the report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.
The committee gratefully acknowledges the staff of the U.S. Environmental Protection Agency for their presentations to the committee during open sessions.
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Contents
Transparency and Communication
EPA’s Approach to Prioritizing Health Outcomes
EPA’s Systematic Review Methods
EPA’s Consideration of Potential Health Effects from Early Life Exposures
Mode-of-Action Information to Inform Dose-Response Analyses
Hierarchical, Bayesian Meta-Regression Approach
Modeling Approaches to Investigate Dose-Response Relationships
A DISSENTING STATEMENT AND REBUTTAL
B BIOSKETCHES OF COMMITTEE TO EVALUATE THE IRIS PROTOCOL FOR INORGANIC ARSENIC
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