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
Washington, DC
www.nap.edu
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This activity was supported by a contract (W81K04-16-D-0036/W81K0418F0055) between the National Academy 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.
International Standard Book Number-13: 978-0-309-49924-8
International Standard Book Number-10: 0-309-49924-0
Digital Object Identifier: https://doi.org/10.17226/25610
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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.
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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
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:
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 presentations to the committee during the public meeting.
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Contents
2 APPROACHES TO DEVELOPING EXPOSURE VALUES
Development of Occupational Exposure Guidelines
Development of Public Health Exposure Guidelines
DOD’s Conceptual Approach to Deriving an OEL
3 SCOPING AND PROBLEM FORMULATION
Selection of the Hazard Assessment Method
5 QUANTITATIVE DOSE-RESPONSE ASSESSMENT AND DERIVATION OF OCCUPATIONAL EXPOSURE LEVELS
Selection of Studies for Dose-Response Assessment and Determine Points of Departure
Application of PBPK Modeling for HEC Determinations
Use of Extrapolation Tools for Derivation of Uncertainty Factors
DOD Approach for Deriving an OEL
BOX, FIGURES, AND TABLES
BOX
3-1 PECO Statement for DOD’s Systematic Literature Search of TCE
FIGURES
2-2 Overview of DOD’s process for deriving an occupational exposure level for TCE
TABLES
2-1 Candidate OELs Developed by DOD
3-1 Advantages and Disadvantages of Narrative Review and Systematic Review Methods
6-1 Evaluation of DOD’s Systematic Review Using the AMSTAR 2 Critical Appraisal Tool
