Review of the
Department of Defense
Biokinetic Modeling Approach in
Support of Establishing an
Airborne Lead Exposure Limit
Committee to Review DoD’s Proposed Occupational Exposure Limits for Lead
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
THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001
This activity was supported by a contract (W81K04-16-D-0036/W81K0418F0054) 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: 978-0-309-67192-7
International Standard Book Number-10: 0-309-67192-2
Digital Object Identifier: https://doi.org/10.17226/25683
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 2020 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. 2020. Review of the Department of Defense Biokinetic Modeling Approach in Support of Establishing an Airborne Lead Exposure Limit. Washington, DC: The National Academies Press. https://doi.org/10.17226/25683.
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 Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. John L. Anderson 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.
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 DOD’S PROPOSED OCCUPATIONAL EXPOSURE LIMITS FOR LEAD
Members
Justin G. Teeguarden (Chair), Pacific Northwest National Laboratory, Richland, WA
Jeffrey W. Fisher, U.S. Food and Drug Administration, Jefferson, AR
Gary L. Ginsberg, New York State Department of Health, Albany
Philip E. Goodrum, GSI Environmental Inc., Fayetteville, NY
Sheryl A. Milz, University of Toledo, OH
Roberta B. Ness (NAM), University of Texas Health Science Center (retired), Houston
Gurumurthy Ramachandran, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD
Brad Reisfeld, Colorado State University, Fort Collins
Staff
Raymond A. Wassel, Project Director
Susan N. J. Martel, Senior Program Officer for Toxicology (until December 31, 2019)
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
Germaine M. Buck Louis, George Mason University, Fairfax, VA
E. William Colglazier, American Association for the Advancement of Science, Washington, DC
Francesca Dominici, Harvard University, Boston, MA
George Gray, The George Washington University, Washington, DC
R. Jeffrey Lewis, ExxonMobil Biomedical Sciences, Inc., Annandale, NJ
Linsey C. Marr, Virginia Polytechnic Institute and State University, Blacksburg
R. Craig Postlewaite, U.S. Department of Defense, Burke, VA
Reza J. Rasoulpour, Corteva Agriscience, Indianapolis, IN
Ivan Rusyn, Texas A&M University, College Station
Deborah L. Swackhamer, University of Minnesota, St. Paul
Joshua Tewksbury, Future Earth, Boulder, CO
Sacoby M. Wilson, University of Maryland, College Park
Staff
Clifford S. Duke, Director
Raymond A. Wassel, Scholar and Director of Environmental Studies
Susan N. J. Martel, Senior Program Officer for Toxicology (until December 31, 2019)
Laura Llanos, Finance Business Partner
Tamara Dawson, Program Associate
Acknowledgments
In the course of preparing its report, the committee held a public information-gathering session on June 13, 2019, to hear presentations from James Brown (U.S. Environmental Protection Agency), John Seibert (U.S. Department of Defense), Lisa Sweeney (UES, Inc.), and Kathleen Vork (California Environmental Protection Agency). Desmond Bannon (U.S. Department of Defense) served as the sponsor’s point of contact during the study and facilitated responses to committee requests for written information.
This Consensus Study Report was reviewed in draft form by individuals 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 the institutional standards for 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 individuals for their review of this report:
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 this report was overseen by Mark Cullen, Stanford University, and Michael McCawley, West Virginia University. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.
This page intentionally left blank.
Acronyms and Abbreviations
ACGIH | American Conference of Governmental Industrial Hygienists |
ACSL | Advanced Continuous Simulation Language |
AF | absorption fraction |
BLL | blood lead level |
CV | coefficient of variation |
DoD | U.S. Department of Defense |
DOEHRS | Defense Occupational and Environmental and Health Readiness System |
EPA | U.S. Environmental Protection Agency |
GFR | glomerular filtration rate |
GI | gastrointestinal |
GSD | geometric standard deviation |
ITC | inhalation transfer coefficient |
MATLAB | Matrix Laboratory |
OEL | occupational exposure limit |
OSHA | Occupational Safety and Health Administration |
Pb | lead |
PBPK | physiologically-based pharmacokinetic |
PEL | permissible exposure limit |
RBC | red blood cell |
TB | tracheo-bronchial |
TLV | threshold limit value |
TWA | time-weighted average |
µg/dL | microgram per deciliter |
µg/m3 | microgram per cubic meter |
This page intentionally left blank.
Contents
DoD’s Initiative to Develop Airborne Lead Occupational Exposure Limits
Committee’s Statement of Task for the Review of the DoD-O’Flaherty Model
2 COMMITTEE’S APPROACH TO ITS TASK
Considerations for Determining Model Appropriateness
3 COMMITTEE’S REVIEW OF THE DOD-O’FLAHERTY MODEL
Was an Appropriate Model Chosen?
Were Structural Modifications to the Model Justified?
Were the Model Assumptions and Inputs Reasonable?
This page intentionally left blank.