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Suggested Citation:"Front Matter." 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. doi: 10.17226/25558.
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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

images

THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

Suggested Citation:"Front Matter." 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. doi: 10.17226/25558.
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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

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
International Standard Book Number-10: 0-309-49699-3
Digital Object Identifier: https://doi.org/10.17226/25558

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Copyright 2019 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

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.

Suggested Citation:"Front Matter." 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. doi: 10.17226/25558.
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The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president.

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Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org.

Suggested Citation:"Front Matter." 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. doi: 10.17226/25558.
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Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task.

Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies.

For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo.

Suggested Citation:"Front Matter." 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. doi: 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

Suggested Citation:"Front Matter." 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. doi: 10.17226/25558.
×

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

Suggested Citation:"Front Matter." 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. doi: 10.17226/25558.
×

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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Suggested Citation:"Front Matter." 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. doi: 10.17226/25558.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/25558.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/25558.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/25558.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/25558.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/25558.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/25558.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/25558.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/25558.
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Page viii Cite
Suggested Citation:"Front Matter." 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. doi: 10.17226/25558.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/25558.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/25558.
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The Integrated Risk Information System (IRIS) is a program within the US Environmental Protection Agency (EPA) that is responsible for developing toxicologic assessments of environmental contaminants. An IRIS assessment contains hazard identifications and dose-response assessments of various chemicals related to cancer and noncancer outcomes. Although the program was created to increase consistency among toxicologic assessments within the agency, federal, state, and international agencies and other organizations have come to rely on IRIS assessments for setting regulatory standards, establishing exposure guidelines, and estimating risks to exposed populations.

The EPA has been working on its IRIS assessment of inorganic arsenic (iAs) for many years, and recently released its plans for completing it in the Updated Problem Formulation and Protocol for the Inorganic Arsenic IRIS Assessment. Much of the update was made in response to recommendations in a 2013 report made by the National Academies of Sciences, Engineering, and Medicine. The National Academies recently convened another evaluation of whether the various elements of the IRIS iAs assessment plan are appropriate to synthesize the scientific evidence and quantitate estimates of iAs toxicity. Review of EPA’s IRIS Assessment Plan for Inorganic Arsenic explores the 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, and various approaches to investigate dose-response relationships.

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