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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Review of DOD's Approach to Deriving an Occupational Exposure Level for Trichloroethylene. Washington, DC: The National Academies Press. doi: 10.17226/25610.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Review of DOD's Approach to Deriving an Occupational Exposure Level for Trichloroethylene. Washington, DC: The National Academies Press. doi: 10.17226/25610.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Review of DOD's Approach to Deriving an Occupational Exposure Level for Trichloroethylene. Washington, DC: The National Academies Press. doi: 10.17226/25610.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Review of DOD's Approach to Deriving an Occupational Exposure Level for Trichloroethylene. Washington, DC: The National Academies Press. doi: 10.17226/25610.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Review of DOD's Approach to Deriving an Occupational Exposure Level for Trichloroethylene. Washington, DC: The National Academies Press. doi: 10.17226/25610.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Review of DOD's Approach to Deriving an Occupational Exposure Level for Trichloroethylene. Washington, DC: The National Academies Press. doi: 10.17226/25610.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Review of DOD's Approach to Deriving an Occupational Exposure Level for Trichloroethylene. Washington, DC: The National Academies Press. doi: 10.17226/25610.
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Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Review of DOD's Approach to Deriving an Occupational Exposure Level for Trichloroethylene. Washington, DC: The National Academies Press. doi: 10.17226/25610.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Review of DOD's Approach to Deriving an Occupational Exposure Level for Trichloroethylene. Washington, DC: The National Academies Press. doi: 10.17226/25610.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Review of DOD's Approach to Deriving an Occupational Exposure Level for Trichloroethylene. Washington, DC: The National Academies Press. doi: 10.17226/25610.
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PREPUBLICATION COPY Review of DOD’s Approach to Deriving an Occupational Exposure Level for Trichloroethylene Committee to Review DOD’s Approach to Deriving an Occupational Exposure Limit for TCE 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 activity was supported by a contract (W81K04-16-D-0036/W81K0418F0055) between the National Acad- emy of Sciences and the U.S. Department of Defense. 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. Digital Object Identifier: https://doi.org/10.17226/25610 Additional copies of this publication are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. 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 DOD’s Approach to Deriving an Occupational Exposure Level for Trichloroethylene. Washington, DC: The National Academies Press. https://doi.org/10.17226/25610. Prepublication Copy

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 re- lated to science and technology. Members are elected by their peers for outstanding contribu- tions to research. Dr. Marcia McNutt is president. The National Academy of Engineering was established in 1964 under the charter of the Na- tional Academy of Sciences to bring the practices of engineering to advising the nation. Mem- bers are elected by their peers for extraordinary contributions to engineering. Dr. John L. An- derson 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 Medicine 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 understanding in matters of science, engineering, and medicine. Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org. Prepublication Copy

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 au- thoring committee of experts. Reports typically include findings, conclusions, and recommen- dations 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 rep- resents 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. Prepublication Copy

COMMITTEE TO REVIEW DOD’S APPROACH TO DERIVING AN OCCUPATIONAL EXPOSURE LIMIT FOR TCE Members Edward C. Bishop (Chair), HDR, Inc. (retired), Council Bluffs, IA Richard A. Corley, Greek Creek Toxicokinetics, LLC, Boise, ID Anneclaire J. De Roos, Drexel University, Philadelphia, PA David C. Dorman, North Carolina State University, Raleigh Theodore J. Hogan, Northern Illinois University, DeKalb Juleen Lam, California State University, East Bay, Hayward Karen A. Robinson, Johns Hopkins University, Baltimore, MD Elizabeth P. Ryan, Colorado State University, Fort Collins Kary E. Thompson, Bristol-Myers Squibb Company, New Brunswick, NJ Carol S. Wood, Oak Ridge National Laboratory, Oak Ridge, TN Staff Susan N.J. Martel, Senior Program Officer Tamara Dawson, Program Associate Sponsor U.S. Department of Defense Prepublication Copy v

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 vi Prepublication Copy

Acknowledgments This Consensus Study Report was reviewed in draft form by persons chosen for their diverse perspec- tives and technical expertise. The purpose of this independent review is to provide candid and critical com- ments that will assist the National Academies of Sciences, Engineering, and Medicine in making each pub- lished 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 con- fidential to protect the integrity of the deliberative process. We thank the following for their review of this report: Weihsueh Chiu, Texas A&M University Kathleen Gilbert, University of Arkansas for Medical Sciences (retired) Tee Guidotti, Consultant Charles Poole, University of North Carolina at Chapel Hill Vicki Sutherland, National Toxicology Program Katya Tsaioun, Johns Hopkins Bloomberg School of Public Health 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 Joseph Rodricks, Ramboll Environ, 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. Department of Defense for their presen- tations to the committee during the public meeting. Prepublication Copy vii

Contents SUMMARY ......................................................................................................................................................... 1 1 INTRODUCTION........................................................................................................................................ 5 Committee’s Task and Approach, 5 Organization of the Report, 6 References, 6 2 APPROACHES TO DEVELOPING EXPOSURE VALUES .................................................................. 8 Development of Occupational Exposure Guidelines, 8 Development of Public Health Exposure Guidelines, 9 DOD’s Conceptual Approach to Deriving an OEL, 10 Findings, 11 References, 12 3 SCOPING AND PROBLEM FORMULATION ..................................................................................... 14 Scoping, 14 Problem Formulation, 15 Selection of the Hazard Assessment Method, 18 Findings, 18 References, 19 4 HAZARD IDENTIFICATION ................................................................................................................. 20 Systematic Review, 20 Integrate Evidence, 25 Findings, 25 References, 26 5 QUANTITATIVE DOSE-RESPONSE ASSESSMENT AND DERIVATION OF OCCUPATIONAL EXPOSURE LEVELS ............................................................................................. 29 Selection of Studies for Dose-Response Assessment and Determine Points of Departure, 29 Dose-Response Assessment, 30 Application of PBPK Modeling for HEC Determinations, 31 Use of Extrapolation Tools for Derivation of Uncertainty Factors, 32 Cancer Exposure-Response Assessment, 32 Findings, 34 References, 35 6 CONCLUSIONS ........................................................................................................................................ 37 Proposed OEL for Inhaled TCE, 37 DOD Approach for Deriving an OEL, 38 Path Forward, 43 References, 43 APPENDIX BIOSKETCHES OF THE COMMITTEE ..................................................................................................... 46 Prepublication Copy ix

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Trichloroethylene (TCE) is a solvent that is used as a degreasing agent, a chemical intermediate in refrigerant manufacture, and a component of spot removers and adhesives. It is produced in mass quantities but creates dangerous vapors and is an environmental contaminant at many industrial and government facilities, including facilities run by the U.S. Department of Defense (DoD). It is important to determine the safe occupational exposure level (OEL) for the solvent in order to protect the health of workers who are exposed to its vapors. However, there are concerns that the current occupational standards insufficiently protect workers from these health threats.

Review of DOD’s Approach to Deriving an Occupational Exposure Level for Trichloroethylene makes recommendations to improve the DoD’s approach to developing an OEL for TCE, strengthen transparency of the process, and improve confidence in the final OEL value. This report reviews the DoD’s approach using a literature review, evidence synthesis based on weight of evidence [WOE], point-of-departure derivation, physiologically based pharmacokinetic modeling, extrapolation tools, and explores other elements of the process of deriving an OEL for TCE. It examines scientific approaches to developing exposure values and cancer risk levels, defining the scope of the problem, and improving hazard identification.

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