Assessment of the NIOSH Head-and-Face Anthropometric Survey of U.S. Respirator Users

Committee for the Assessment of the NIOSH Head-and-Face Anthropometric Survey of U.S. Respirator Users

Board on Health Sciences Policy

John C. Bailar III, Emily Ann Meyer, and Robert Pool, Editors

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
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Assessment of the NIOSH Head-and-Face Anthropometric Survey of U.S. Respirator Users Assessment of the NIOSH Head-and-Face Anthropometric Survey of U.S. Respirator Users Committee for the Assessment of the NIOSH Head-and-Face Anthropometric Survey of U.S. Respirator Users Board on Health Sciences Policy John C. Bailar III, Emily Ann Meyer, and Robert Pool, Editors INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Assessment of the NIOSH Head-and-Face Anthropometric Survey of U.S. Respirator Users THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This study was supported by Award No. HHSH200-2005-10881 between the National Academy of Sciences and the U.S. Department of Health and Human Services. Any opinions, findings, or conclusions expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number -13: 978-0-309-10398-5 International Standard Book Number -10: 0-309-10398-3 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2007 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Suggested citation: Institute of Medicine (IOM). 2007. Assessment of the NIOSH Head-and-Face Anthropometric Survey of U.S. respirator users. Washington, DC: The National Academies Press.

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Assessment of the NIOSH Head-and-Face Anthropometric Survey of U.S. Respirator Users “Knowing is not enough; we must apply. Willing is no enough; we must do.” —Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Advising the Nation. Improving Health.

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Assessment of the NIOSH Head-and-Face Anthropometric Survey of U.S. Respirator Users THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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Assessment of the NIOSH Head-and-Face Anthropometric Survey of U.S. Respirator Users COMMITTEE FOR THE ASSESSMENT OF THE NIOSH HEAD-AND-FACE ANTHROPOMETRIC SURVEY OF U.S. RESPIRATOR USERS JOHN C. BAILAR III, (Chair), University of Chicago, Illinois LISA M. BROSSEAU, University of Minnesota, Minneapolis HOWARD J. COHEN, University of New Haven, West Haven, Connecticut ALAN L. HACK, Los Alamos, New Mexico SUBHASH R. LELE, University of Alberta, Edmonton, Canada YOUCHENG LIU, Yale University School of Medicine, New Haven, Connecticut JOAN T. RICHTSMEIER, Pennsylvania State University, University Park KNUT RINGEN, Seattle, Washington JAVIER ROJO, Rice University, Houston, Texas ALBERT A. SCIARRETTA, CNS Technologies, Inc., Springfield, Virginia IOM Staff BRUCE M. ALTEVOGT, Study Director (since December 2006) EMILY ANN MEYER, Study Director (until November 2006) SARAH L. HANSON, Research Associate (since December 2006) LORA K. TAYLOR, Senior Project Assistant VILIJA TEEL, Senior Project Assistant

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Assessment of the NIOSH Head-and-Face Anthropometric Survey of U.S. Respirator Users BOARD ON HEALTH SCIENCES POLICY* FRED H. GAGE (Chair), Salk Institute for Biological Studies, La Jolla, California GAIL H. CASSELL, Eli Lilly and Company, Indianapolis, Indiana JAMES F. CHILDRESS, University of Virginia, Charlottesville ELLEN WRIGHT CLAYTON, Vanderbilt University Medical School, Nashville, Tennessee DAVID R. COX, Perlegen Sciences, Mountain View, California LYNN R. GOLDMAN, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland BERNARD D. GOLDSTEIN, University of Pittsburgh, Pennsylvania MARTHA N. HILL, Johns Hopkins University School of Nursing, Baltimore, Maryland ALAN LESHNER, American Association for the Advancement of Science, Washington, D.C. DANIEL MASYS, Vanderbilt University Medical Center, Nashville, Tennessee JONATHAN D. MORENO, University of Virginia, Charlottesville E. ALBERT REECE, University of Maryland School of Medicine, Baltimore MYRL WEINBERG, National Health Council, Washington, D.C. MICHAEL J. WELCH, Washington University School of Medicine, St. Louis, Missouri OWEN N. WITTE, University of California, Los Angeles MARY WOOLLEY, Research!America, Alexandria, Virginia IOM Staff ANDREW M. POPE, Director AMY HAAS, Board Assistant DAVID CODREA, Financial Associate * IOM boards do not review or approve individual reports and are not asked to endorse conclusions and recommendations. The responsibility for the content of the report rests with the authoring committee and the institution.

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Assessment of the NIOSH Head-and-Face Anthropometric Survey of U.S. Respirator Users Independent Report Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for 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 wish to thank the following individuals for their review of this report: David Abrams, ARS Environmental Health, Inc., Minnetonka, Minnesota Jeffrey S. Birkner, Moldex-Metric, Inc., Simi Valley, California Fred L. Bookstein, Department of Statistics and Department of Psychology and Behavioral Sciences, Fetal Alcohol and Drug Unit, University of Washington, Seattle Craig E. Colton, Regulatory Affairs & Training, 3M Occupational Health & Environmental Safety Division, St. Paul, Minnesota Harry Ettinger, Los Alamos National Laboratories, New Mexico, Retired David C. Hoaglin, Abt Associates Inc., Cambridge, Massachusetts James Melius, New York State Laborers’ Union, Albany, New York James Platner, Center to Protect Workers’ Rights, Silver Spring, Maryland Aaron Richardson, Applied Biology and Aerosol Technology, Battelle Memorial Institute, Columbus, Ohio

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Assessment of the NIOSH Head-and-Face Anthropometric Survey of U.S. Respirator Users Tim D. White, Department of Integrative Biology and Human Evolution Research Center, University of California, Berkeley M. Donald Whorton, WorkCare, Inc., Alameda, California Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Dr. Enriqueta C. Bond, Burroughs Wellcome Fund. Appointed by the National Research Council and the Institute of Medicine, she was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Assessment of the NIOSH Head-and-Face Anthropometric Survey of U.S. Respirator Users Acknowledgments The committee acknowledges with appreciation the individuals who provided information to the committee. These individuals include Heinz Ahlers, NIOSH; Roland Berry Ann, NIOSH; Jeffrey Birkner, Moldex; Les Boord, NIOSH; Bill Hoffman, NIOSH; Roy McKay, University of Cincinnati; William Newcomb, NIOSH; Alex Pappas, Edgewood Chemical Biological Center; Jim Platner, Center to Protect Workers’ Rights; Ron Shaffer, NIOSH; Julie Tremblay, Aearo; and Robert Weber, 3M. The committee is especially grateful to Bruce Bradtmiller from Anthrotech, Inc. The National Personal Protective Technology Laboratory at NIOSH sponsored this study. We appreciate their support and especially thank Maryann D’Alessandro and Ziqing Zhuang for their efforts on behalf of this study. We finally would like to thank the IOM staff, including Bruce Altevogt, Judy Estep, Sarah Hanson, Amy Haas, Emily Ann Meyer, Andrew Pope, and Vilija Teel.

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Assessment of the NIOSH Head-and-Face Anthropometric Survey of U.S. Respirator Users Preface This Committee’s task—to examine and assess the adequacy and validity of the National Institute for Occupational Safety and Health (NIOSH)-sponsored Anthrotech Survey of U.S. Respirator Users—was as challenging as it was important. Having effective respiratory protection can be, and often is, a matter of life and death. Yet the scientific bases for developing and fitting effective respiratory protection remain more art than science. A Los Alamos National Laboratory (LANL) respirator fit-test panel, performed in the 1970s and based on a survey of Air Force personnel, has been the basis for testing and certifying respirators for the past 30 years. It is not clear, however, that the Air Force population adequately represented the range of workers even then, and more recent changes in the composition and diversity of the U.S. workforce may make it even less suitable. Developing new test panels for respirators that will fit the changing “face” of the U.S. workforce became an obvious need that NIOSH sought to address in contracting with Anthrotech to conduct a new survey of the U.S. workforce in 2001. NIOSH is to be commended for taking that initiative and also for seeking an independent review of the study’s outcome by the Institute of Medicine (IOM) (as presented in this report). The conduct of our work was interrupted after our second meeting in order to accommodate an urgent request from the DHHS Office of the Secretary for advice on the potential reusability of disposable face masks in protecting against pandemic flu. Some of our committee members served on that committee, and then returned 6 months later to reconvene in addressing this committee’s charge.

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Assessment of the NIOSH Head-and-Face Anthropometric Survey of U.S. Respirator Users It is always easier to critique someone else’s work than it is to develop and conduct new work. And it is with this awareness that our committee offers our evaluation and assessment. We found many weaknesses in the collection and analysis of the data that were used to develop the proposed face panels. The Anthrotech survey, rather than using novel methodology, served more as an update of a 30-year-old strategy with a larger sample population. The study would have been improved greatly by assuring that the sample was representative of workers who should be using respirators, by validating and incorporating three dimensional measures, and by measuring quantitative fit. There was also a surprising lack of detailed information about the methods that were used in its conduct. Nonetheless, the proposed NIOSH face panel represents an improvement over the existing LANL face panel, and its application is likely to improve the availability of respirators that fit a broader segment of the workforce. The committee was not charged to comment on whether or not the survey should be redone. However, the Anthrotech research plan, survey, and data analysis had weaknesses that will limit their reliability for NIOSH purposes. As resources and time become available, NIOSH might undertake a new study with a different strategy and research plan. The committee acknowledges and thanks the IOM staff who supported its efforts, the numerous NIOSH staff who provided detailed information and briefings, and others who provided information in open meetings, and otherwise during the conduct of this study. Appendix A lists the public meeting agendas and meeting participants. The committee most importantly thanks NIOSH for having asked these questions in the first place, for working on updating the respirator test standards, and for having a steadfast dedication to scientific research in support of the health of the public. John C. Bailar III, M.D., Ph.D. Committee Chairman

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Assessment of the NIOSH Head-and-Face Anthropometric Survey of U.S. Respirator Users Contents     SUMMARY   1 1   INTRODUCTION   19      Historical Background,   20      Certification of Face Mask Respirators,   21      Los Alamos National Laboratory Panel,   22      The 2001 NIOSH-Sponsored Anthrotech Study,   23      The Institute of Medicine Review of the NIOSH-Sponsored Anthrotech Study,   24      References,   26 2   ANTHROPOMETRIC MEASUREMENTS   29      The Anthrotech Measurements,   29      Landmarks,   34      Error Estimation,   36      Three-Dimensional Measurements,   38      References,   41 3   THE NIOSH-SPONSORED ANTHROTECH STUDY’S SAMPLING STRATEGY   43      The Anthrotech Sampling Plan,   43      Sampling Protocol,   45      Sample Distribution,   46      Limitations of the Sample Population,   48      References,   52

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Assessment of the NIOSH Head-and-Face Anthropometric Survey of U.S. Respirator Users 4   DATA ANALYSIS AND FIT-TEST PANELS   53      Weighting of Data,   53      Establishing the Face Panel,   61      Validity of the Proposed Face Panels,   66      The Impact of Face Dimension of Fit,   67      Alternative Nonlinear Face Panel Design,   77      References,   79 5   FUTURE DIRECTIONS: ADDITIONAL ANALYSES AND RESEARCH TO PRACTICE   81      Face Panels Require Periodic Updates,   81      Face Panel Validation,   83      Qualitative Fit Testing,   83      Certification of Face Masks,   85      Provide Access to Primary Data,   88      Improving the Practice of Respiratory Protection,   89      Developing Face Panels Applicable to the World’s Workforce,   91      References,   92     APPENDIXES     A   Data Sources and Methods   93 B   Acronyms   99 C   2001 NIOSH Protocol and 2004 NIOSH-Sponsored Anthrotech Report   101 D   Committee and Staff Biographies   103