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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Progress Toward Transforming the Integrated Risk Information System (IRIS) Program: A 2018 Evaluation. Washington, DC: The National Academies Press. doi: 10.17226/25086.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Progress Toward Transforming the Integrated Risk Information System (IRIS) Program: A 2018 Evaluation. Washington, DC: The National Academies Press. doi: 10.17226/25086.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Progress Toward Transforming the Integrated Risk Information System (IRIS) Program: A 2018 Evaluation. Washington, DC: The National Academies Press. doi: 10.17226/25086.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Progress Toward Transforming the Integrated Risk Information System (IRIS) Program: A 2018 Evaluation. Washington, DC: The National Academies Press. doi: 10.17226/25086.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Progress Toward Transforming the Integrated Risk Information System (IRIS) Program: A 2018 Evaluation. Washington, DC: The National Academies Press. doi: 10.17226/25086.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Progress Toward Transforming the Integrated Risk Information System (IRIS) Program: A 2018 Evaluation. Washington, DC: The National Academies Press. doi: 10.17226/25086.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Progress Toward Transforming the Integrated Risk Information System (IRIS) Program: A 2018 Evaluation. Washington, DC: The National Academies Press. doi: 10.17226/25086.
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Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Progress Toward Transforming the Integrated Risk Information System (IRIS) Program: A 2018 Evaluation. Washington, DC: The National Academies Press. doi: 10.17226/25086.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Progress Toward Transforming the Integrated Risk Information System (IRIS) Program: A 2018 Evaluation. Washington, DC: The National Academies Press. doi: 10.17226/25086.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Progress Toward Transforming the Integrated Risk Information System (IRIS) Program: A 2018 Evaluation. Washington, DC: The National Academies Press. doi: 10.17226/25086.
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Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Progress Toward Transforming the Integrated Risk Information System (IRIS) Program: A 2018 Evaluation Committee to Review Advances Made to the IRIS Process Board on Environmental Studies and Toxicology Division on Earth and Life Studies A Consensus Study Report of

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 This project was supported by Contract EP-C-14-005, TO#008 between the National Academies of Sciences, Engineering, and Medicine and the US Environmental Protection Agency. Any opinions, findings, conclu- sions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of any organization or agency that provided support for this project. Digital Object Identifier: https://doi.org/10.17226/25086 Copyright 2018 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. 2018. Progress Toward Transforming the Integrated Risk Information System (IRIS) Program: A 2018 Evaluation. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/25086.

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. The National Academy of Engineering was established in 1964 under the charter of the National Acad- emy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. C. D. Mote, Jr., is president. The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president. The three Academies work together as the National Academies of Sciences, Engineering, and Medi- cine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public under- standing in matters of science, engineering, and medicine. Learn more about the National Academies of Sciences, Engineering, and Medicine at www.national academies.org.

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.

COMMITTEE TO REVIEW ADVANCES MADE TO THE IRIS PROCESS Members JONATHAN M. SAMET (Chair), Colorado School of Public Health, Denver, CO RICHARD A. CORLEY (retired), Pacific Northwest National Laboratories, Richland, WA GEORGE DASTON, Proctor & Gamble Company, Cincinnati, OH DAVID C. DORMAN, North Carolina State University, Raleigh, NC RUSS B. HAUSER, Harvard T.H. Chan School of Public Health, Boston, MA KAREN A. ROBINSON, Johns Hopkins University, Baltimore, MD RICHARD P. SCHEINES, Carnegie Mellon University, Pittsburgh, PA LAUREN ZEISE, CalEPA Office of Environmental Health Hazard Assessment, Berkeley, CA YILIANG ZHU, University of New Mexico, Albuquerque, NM Staff ELLEN K. MANTUS, Project Director RADIAH ROSE-CRAWFORD, Manager, Editorial Projects SUZANNE THILENIUS, Administrative Coordinator MIRSADA KARALIC-LONCAREVIC, Manager, Technical Information Center JESSICA WOLFMAN, Senior Program Assistant Sponsor US ENVIRONMENTAL PROTECTION AGENCY v

BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY Members WILLIAM H. FARLAND (Chair), Colorado State University, Fort Collins, CO 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, DE DAVID C. DORMAN, North Carolina State University, Raleigh, NC CHARLES T. DRISCOLL, JR., Syracuse University, Syracuse, NY ANNE FAIRBROTHER, Exponent, Inc., Philomath, OR GEORGE GRAY, The George Washington University, Washington, DC STEVEN P. HAMBURG, Environmental Defense Fund, New York, NY ROBERT A. HIATT, University of California, San Francisco, CA SAMUEL KACEW, University of Ottawa, Ontario, Canada H. SCOTT MATTHEWS, Carnegie Mellon University, Pittsburgh, PA ROBERT PERCIASEPE, Center for Climate and Energy Solutions, Arlington, VA R. CRAIG POSTLEWAITE, US Department of Defense, Burke, VA MARK A. RATNER, Northwestern University, Evanston, IL JOAN B. ROSE, Michigan State University, East Lansing, MI GINA M. SOLOMON, California Environmental Protection Agency, Sacramento, CA ROBERT M. SUSSMAN, Sussman and Associates, Washington, DC DEBORAH L. SWACKHAMER, University of Minnesota, St. Paul, MN PETER S. THORNE, University of Iowa, Iowa City, IA Staff TERESA A. FRYBERGER, Director ELLEN K. MANTUS, Scholar and Director of Risk Assessment RAYMOND A. WASSEL, Scholar and Director of Environmental Studies SUSAN N.J. MARTEL, Senior Program Officer for Toxicology ELIZABETH BOYLE, Program Officer TAMARA DAWSON, Program Associate BERNIDEAN WILLIAMS-SMITH, Financial Associate SUZANNE THILENIUS, Administrative Coordinator JESSICA WOLFMAN, Senior Program Assistant vi

Acknowledgments This Consensus Study Report was reviewed in draft form by persons chosen for their diverse per- spectives 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, objec- tivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript re- main confidential to protect the integrity of the deliberative process. We thank the following for their review of this report: David Eaton, University of Washington David Savitz, Brown University Joyce Tsuji, Exponent Harvey Clewell, Ramboll Lisa Bero, University of Sidney Nancy Reid, University of Toronto 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 Mark Cullen, Stanford University, who was responsible for making certain that an independent examination of the report was carried out in ac- cordance with institutional procedures and that all review comments were carefully considered. Respon- sibility for the final content rests entirely with the authoring committee and the National Academies. The committee gratefully acknowledges the staff of the US Environmental Protection Agency, espe- cially Tina Bahadori and Kristina Thayer, for their presentations to the committee during open sessions. The committee is also grateful for the assistance of Norman Grossblatt who served as the report editor. vii

Contents SUMMARY ......................................................................................................................................................... 1 1 INTRODUCTION........................................................................................................................................ 2 The Integrated Risk Information System and Previous National Academies Reports, 2 The Committee, Its Task, and Its Approach, 3 Organization of the Report, 4 References, 4 2 RESPONSES TO NATIONAL ACADEMIES RECOMMENDATIONS .............................................. 5 General Process Issues, 5 Systematic Review: Problem Formulation, Protocol Development, and Evidence Identification and Evaluation, 6 Evidence Integration, 8 Derivation of Toxicity Values, 10 Concluding Remarks, 12 References, 12 APPENDIXES A BIOGRAPHIC INFORMATION ON THE COMMITTEE TO REVIEW ADVANCES MADE TO THE IRIS PROCESS .......................................................................................................... 14 B WORKSHOP AGENDA ........................................................................................................................ 17 C PRESENTATIONS BY US ENVIRONMENTAL PROTECTION AGENCY .................................. 20 D POSTERS BY US ENVIRONMENTAL PROTECTION AGENCY ................................................. 99 E FINDINGS REGARDING INDIVIDUAL RECOMMENDATIONS .............................................. 110 BOXES AND FIGURE BOXES 1-1 Statement of Task, 4 2-1 Environmental Protection Agency Description of Its Portfolio Approach, 6 FIGURE 1-1 The IRIS process in the context of systematic review, 3 ix

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Over the past several years, the US Environmental Protection Agency (EPA) has been transforming the procedures of its Integrated Risk Information System (IRIS), a program that produces hazard and dose‒response assessments of environmental chemicals and derives toxicity values that can be used to estimate risks posed by exposures to them. The transformation was initiated after suggestions for program reforms were provided in a 2011 report from the National Academies of Sciences, Engineering, and Medicine that reviewed a draft IRIS assessment of formaldehyde. In 2014, the National Academies released a report that reviewed the IRIS program and evaluated the changes implemented in it since the 2011 report.

Since 2014, new leadership of EPA’s National Center for Environmental Assessment (NCEA) and IRIS program has instituted even more substantive changes in the IRIS program in response to the recommendations in the 2014 report. Progress Toward Transforming the Integrated Risk Information System Program: A 2018 Evaluation reviews the EPA’s progress toward addressing the past recommendations from the National Academies.

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