Review of the U.S. Navy's Exposure Standard for Manufactured Vitreous Fibers

Subcommittee on Manufactured Vitreous Fibers

Committee on Toxicology

Board on Environmental Studies and Toxicology

Commission on Life Sciences

National Research Council

NATIONAL ACADEMY PRESS
Washington D.C.



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Review of the U.S. Navy's Exposure Standard for Manufactured Vitreous Fibers Review of the U.S. Navy's Exposure Standard for Manufactured Vitreous Fibers Subcommittee on Manufactured Vitreous Fibers Committee on Toxicology Board on Environmental Studies and Toxicology Commission on Life Sciences National Research Council NATIONAL ACADEMY PRESS Washington D.C.

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Review of the U.S. Navy's Exposure Standard for Manufactured Vitreous Fibers NATIONAL ACADEMY PRESS 2101 Constitution Ave., N.W.Washington, D.C. 20418 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 project was supported by Contracts DAMD17-89-C-9086 and DAMD17-99-C-9049 between the National Academy of Sciences and the U.S. Department of Defense. Any opinions, findings, conclusions, or recommendations 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 0-309-07093-7 Additional copies of this report are available from:National Academy Press 2101 Constitution Ave., NW Box 285 Washington, DC 20055 800-624-6242 202-334-3313 (in the Washington metropolitan area) http://www.nap.edu Copyright 2000 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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Review of the U.S. Navy's Exposure Standard for Manufactured Vitreous Fibers THE NATIONAL ACADEMIES National Academy of Sciences National Academy of Engineering Institute of Medicine National Research Council 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. Bruce M. Alberts 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. William 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. Kenneth I. Shine 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. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.

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Review of the U.S. Navy's Exposure Standard for Manufactured Vitreous Fibers SUBCOMMITTEE ON MANUFACTURED VITREOUS FIBERS MORTON LIPPMANN (Chair), New York University School of Medicine, Tuxedo, New York LEONARD CHIAZZE, Georgetown University School of Medicine, Washington, D.C. DAVID B. COULTAS, University of New Mexico, Albuquerque, New Mexico KEVIN E. DRISCOLL, Procter & Gamble Pharmaceuticals, Cincinnati, Ohio AGNES B. KANE, Brown University, Providence, Rhode Island JAMES E. LOCKEY, University of Cincinnati, Cincinnati, Ohio ERNEST E. MCCONNELL, ToxPath, Inc., Raleigh, North Carolina GÜNTER OBERDÖRSTER, University of Rochester Medical School, Rochester, New York LORENZ R. RHOMBERG, Gradient Corporation, Cambridge, Massachusetts MARK UTELL, University of Rochester Medical Center, Rochester, New York DAVID B.WARHEIT, DuPont Haskell Laboratory, Newark, Delaware STAFF KULBIR S. BAKSHI, Program Director, Committee on Toxicology ROBERTA M. WEDGE, Project Director EILEEN N. ABT, Research Associate NORMAN GROSSBLATT, Editor MIRSADA KARALIC-LONCAREVIC, Information Specialist LUCY V. FUSCO, Project Assistant LINDA LEONARD, Project Assistant SPONSOR U.S. DEPARTMENT OF DEFENSE

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Review of the U.S. Navy's Exposure Standard for Manufactured Vitreous Fibers COMMITTEE ON TOXICOLOGY BAILUS WALKER, JR., (CHAIR), Howard University Medical Center and American Public Health Association, Washington, D.C. MELVIN E. ANDERSEN, Colorado State University, Denver, Colorado GERMAINE M. BUCK, University at Buffalo, State of New York ROBERT E. FORSTER II, University of Pennsylvania, Philadelphia, Pennsylvania PAUL M.D. FOSTER, Chemical Industry Institute of Toxicology, Research Triangle Park, North Carolina WILLIAM E. HALPERIN, National Institute for Occupational Safety and Health, Cincinnati, Ohio CHARLES H. HOBBS, Lovelace Respiratory Research Institute and Lovelace Biomedical and Environmental Research Institute, Albuquerque, New Mexico SAMUEL KACEW, University of Ottawa, Ontario, Canada NANCY KERKVLIET, Oregon State University, Corvallis, Oregon FLORENCE K. KINOSHITA, Hercules Incorporated, Wilmington, Delaware MICHAEL J. KOSNETT, University of Colorado Health Sciences Center, Denver, Colorado MORTON LIPPMANN, New York University School of Medicine, Tuxedo, New York ERNEST E. MCCONNELL, ToxPath, Inc., Raleigh, North Carolina THOMAS E. MCKONE, Lawrence Berkeley National Laboratory and University of California, Berkeley, California HARIHARA MEHENDALE, The University of Louisiana of Louisiana at Monroe, Louisiana DAVID H. MOORE, Battelle Memorial Institute, Bel Air, Maryland GÜNTER OBERDÖRSTER, University of Rochester, Rochester, New York JOHN L. O'DONOGHUE, Eastman Kodak Company, Rochester, New York GEORGE M. RUSCH, AlliedSignal, Inc., Morristown, New Jersey MARY E. VORE, University of Kentucky, Lexington, Kentucky ANNETTA P. WATSON, Oak Ridge National Laboratory, Oak Ridge, Tennessee LAUREN ZEISE, California Environmental Protection Agency, Oakland, California STAFF KULBIR S. BAKSHI, Program Director SUSAN N.J. PANG, Program Officer ABIGAIL E. STACK, Program Officer MICHELLE C. CATLIN, Research Associate RUTH E. CROSSGROVE, Publications Manager KATHRINE J. IVERSON, Manager, Toxicology Information Center EMILY SMAIL, Project Assistant

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Review of the U.S. Navy's Exposure Standard for Manufactured Vitreous Fibers BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY GORDON ORIANS (Chair), University of Washington, Seattle, Washington DONALD MATTISON (Vice Chair), March of Dimes, White Plains, New York DAVID ALLEN, University of Texas, Austin, Texas INGRID C. BURKE, Colorado State University, Fort Collins, Colorado WILLIAM L. CHAMEIDES, Georgia Institute of Technology, Atlanta, Georgia JOHN DOULL, University of Kansas Medical Center, Kansas City, Kansas CHRISTOPHER B. FIELD, Carnegie Institute of Washington, Stanford, California JOHN GERHART, University of California, Berkeley, California J. PAUL GILMAN, Celera Genomics, Rockville, Maryland BRUCE D. HAMMOCK, University of California, Davis, California MARK HARWELL, University of Miami, Miami, Florida ROGENE HENDERSON, Lovelace Respiratory Research Institute, Albuquerque, New Mexico CAROL HENRY, Chemical Manufacturers Association, Arlington, Virginia BARBARA HULKA, University of North Carolina, Chapel Hill, North Carolina JAMES F. KITCHELL, University of Wisconsin, Madison, Wisconsin DANIEL KREWSKI, University of Ottawa, Ottawa, Ontario, Canada JAMES A. MACMAHON, Utah State University, Logan, Utah MARIO J. MOLINA, Massachusetts Institute of Technology, Cambridge, Massachusetts CHARLES O'MELIA, Johns Hopkins University, Baltimore, Maryland WILLEM F. PASSCHIER, Health Council of the Netherlands KIRK SMITH, University of California, Berkeley, California MARGARET STRAND, Oppenheimer Wolff Donnelly & Bayh, LLP, Washington, D.C. TERRY F. YOSIE, Chemical Manufacturers Association, Arlington, Virginia SENIOR STAFF JAMES J. REISA, Director DAVID J. POLICANSKY, Associate Director and Senior Program Director for Applied Ecology CAROL A. MACZKA, Senior Program Director for Toxicology and Risk Assessment RAYMOND A. WASSEL, Senior Program Director for Environmental Sciences and Engineering KULBIR BAKSHI, Program Director for the Committee on Toxicology LEE R. PAULSON, Program Director for Resource Management ROBERTA M. WEDGE, Program Director for Risk Analysis

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Review of the U.S. Navy's Exposure Standard for Manufactured Vitreous Fibers COMMISSION ON LIFE SCIENCES MICHAEL, T. CLEGG (Chair), University of California, Riverside, California PAUL BERG (Vice Chair), Stanford University, Stanford, California FREDERICK R. ANDERSON, Cadwalader, Wickersham & Taft, Washington, D.C. JOANNA BURGER, Rutgers University, Piscataway, New Jersey JAMES E. CLEAVER, University of California, San Francisco, California DAVID EISENBERG, University of California, Los Angeles, California JOHN EMMERSON, Fishers, Indiana NEAL FIRST, University of Wisconsin, Madison, Wisconsin DAVID J. GALAS, Keck Graduate Institute of Applied Life Science, Claremont, California DAVID V. GOEDDEL, Tularik, Inc., South San Francisco, California ARTURO GOMEZ-POMPA, University of California, Riverside, California COREY S. GOODMAN, University of California, Berkeley, California JON W. GORDON, Mount Sinai School of Medicine, New York, New York DAVID G. HOEL, Medical University of South Carolina, Charleston, South Carolina BARBARA S. HULKA, University of North Carolina, Chapel Hill, North Carolina CYNTHIA KENYON, University of California, San Francisco, California BRUCE R. LEVIN, Emory University, Atlanta, Georgia DAVID LIVINGSTON, Dana-Farber Cancer Institute, Boston, Massachusetts DONALD R. MATTISON, March of Dimes, White Plains, New York ELLIOT M. MEYEROWITZ, California Institute of Technology, Pasadena, California ROBERT T. PAINE, University of Washington, Seattle, Washington RONALD R. SEDEROFF, North Carolina State University, Raleigh, North Carolina ROBERT R. SOKAL, State University of New York, Stony Brook, New York CHARLES F. STEVENS, Salk Institute, La Jolla, California SHIRLEY M. TILGHMAN, Princeton University, Princeton, New Jersey RAYMOND L. WHITE, University of Utah, Salt Lake City, Utah STAFF WARREN R. MUIR, Executive Director JACQUELINE K. PRINCE, Financial Officer BARBARA B. SMITH, Administrative Associate LAURA T. HOLLIDAY, Senior Program Assistant

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Review of the U.S. Navy's Exposure Standard for Manufactured Vitreous Fibers OTHER REPORTS OF THE BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY Strengthening Science at the U.S. Environmental Protection Agency: Research Management and Peer Review Practice (2000) Scientific Frontiers in Developmental Toxicology and Risk Assessment (2000) Modeling Mobile-Source Emissions (2000) Copper in Drinking Water (2000) Ecological Indicators for the Nation (2000) Waste Incineration and Public Health (1999) Hormonally Active Agents in the Environment (1999) Research Priorities for Airborne Particulate Matter: I. Immediate Priorities and a Long-Range Research Portfolio (1998); II. Evaluating Research Progress and Updating the Portfolio (1999) Ozone-Forming Potential of Reformulated Gasoline (1999) Risk-Based Waste Classification in California (1999) Arsenic in Drinking Water (1999) Brucellosis in the Greater Yellowstone Area (1998) The National Research Council's Committee on Toxicology: The First 50 Years (1997) Toxicologic Assessment of the Army's Zinc Cadmium Sulfide Dispersion Tests (1997) Carcinogens and Anticarcinogens in the Human Diet (1996) Upstream: Salmon and Society in the Pacific Northwest (1996) Science and the Endangered Species Act (1995) Wetlands: Characteristics and Boundaries (1995) Biologic Markers (5 reports, 1989-1995) Review of EPA's Environmental Monitoring and Assessment Program (3 reports, 1994-1995) Science and Judgment in Risk Assessment (1994) Ranking Hazardous Waste Sites for Remedial Action (1994) Pesticides in the Diets of Infants and Children (1993) Issues in Risk Assessment (1993) Setting Priorities for Land Conservation (1993) Protecting Visibility in National Parks and Wilderness Areas (1993) Dolphins and the Tuna Industry (1992) Hazardous Materials on the Public Lands (1992) Science and the National Parks (1992) Animals as Sentinels of Environmental Health Hazards (1991)

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Review of the U.S. Navy's Exposure Standard for Manufactured Vitreous Fibers Assessment of the U.S. Outer Continental Shelf Environmental Studies Program, Volumes I-IV (1991-1993) Human Exposure Assessment for Airborne Pollutants (1991) Monitoring Human Tissues for Toxic Substances (1991) Rethinking the Ozone Problem in Urban and Regional Air Pollution (1991) Decline of the Sea Turtles (1990) Copies of these reports may be ordered from the National Academy Press (800) 624-6242 (202) 334-3313 www.nap.edu

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Review of the U.S. Navy's Exposure Standard for Manufactured Vitreous Fibers PREFACE THE U.S. Navy Environmental Health Center (NEHC), part of the Bureau of Medicine and Surgery, oversees the Navy's Occupational Safety and Health Program. In 1995, the NEHC established an occupational exposure standard of 2 fibers per cubic centimeter for manufactured vitreous fibers to protect workers against adverse health effects. Recently, this standard was lowered to 1 fiber per cubic centimeter to comply with existing guidelines developed by other industrial hygiene organizations. In setting the earlier exposure standard, the Navy reviewed the toxicological and epidemiological studies available in the published scientific literature and the rationales used by the National Institute for Occupational Safety and Health in developing its recommended exposure limit of 3 fibers per cubic centimeter and the Occupational Safety and Health Administration in proposing a permissible exposure limit of 1 fiber per cubic centimeter. The Navy chose an occupational exposure limit that was an average of those two values. In this report, the Subcommittee on Manufactured Vitreous Fibers of the National Research Council (NRC) Committee on Toxicology reviews independently the scientific validity of the Navy's exposure limit and determines whether any additional scientific studies should be considered by the Navy in choosing its exposure limit. To prepare the report, the subcommittee reviewed the materials supplied by the Navy, and by other organization's and individuals, and information gathered at a public meeting held at the J. Erik Jonsson Woods Hole Center, Massachusetts, on July 16, 1998. This report is intended to assist the

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Review of the U.S. Navy's Exposure Standard for Manufactured Vitreous Fibers Navy in developing a process for establishing occupational exposure limits for other materials and to highlight concerns that might influence the choice of a protective value. The subcommittee wishes to thank David A. Macys, program officer, of the Office of Naval Research, and Patricia Krevonick, senior industrial hygienist, of the NEHC, for their presentations at the public meeting and for their responses to written questions from the subcommittee. We also gratefully acknowledge John Hadley, corporate toxicologist of Owens Corning for making a presentation to the subcommittee. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures for reviewing NRC reports approved by the NRC's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist NRC in making the 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 content of the final report is the responsibility of NRC and the study subcommittee, and not of the reviewers. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals, who are neither officials nor employees of NRC, for their participation in the review of this report: Andrew Churg, University of British Columbia; Walter Eastes, Owens Corning Corporation; Jeffrey Everitt, Chemical Industry Institute of Toxicology; Thomas Hesterberg, Johns Manville Corporation; Daniel Luchtel, University of Washington; Gary Marsh, University of Pittsburgh; Roger McClellan, Chemical Industry Institute of Toxicology (retired); and Vanessa Vu, U.S. Environmental Protection Agency. These reviewers have provided many constructive comments and suggestions; it must be emphasized, however, that responsibility for the final content of this report rests entirely with the authoring subcommittee and NRC. I am also grateful for the assistance of the NRC staff in the preparation of this report. In particular, the subcommittee wishes to acknowledge Kulbir Bakshi, program director of the Committee on Toxicology; Roberta Wedge, staff officer for the subcommittee; and Eileen Abt, research associate. Other staff members who contributed to this effort are Norman Grossblatt, editor; Lucy Fusco and Linda Leonard, project assistants, and Mirsada Karalic-Loncarevic, information specialist. Finally, I would like to thank the members of the subcommittee for

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Review of the U.S. Navy's Exposure Standard for Manufactured Vitreous Fibers their valuable expertise and dedicated efforts throughout the preparation of this report. Their efforts in preparing this report within a very short time are much appreciated. Morton Lippmann, Ph.D. Chair, Subcommittee on Manufactured Vitreous Fibers

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Review of the U.S. Navy's Exposure Standard for Manufactured Vitreous Fibers CONTENTS     SUMMARY   1  1   INTRODUCTION   7      Background,   7      The Subcommittee's Task,   11      Organization of the Report,   12  2   MANUFACTURING PROCESSES, CHEMICAL COMPOSITION, AND CLASSIFICATION   13      Glass Fibers,   14      Mineral Wool,   16      Refractory Ceramic Fibers,   16      Conclusions,   17  3   SAMPLING, ANALYTIC METHODS, AND EXPOSURE ASSESSMENT   18      Sampling and Analysis,   18      Exposure Assessment,   20      Conclusions,   21  4   BIOPERSISTENCE OF VITREOUS FIBERS   23      Defining Biopersistence,   23      Assessing Biopersistence,   25      Measuring Biopersistence,   27      Conclusions,   33

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Review of the U.S. Navy's Exposure Standard for Manufactured Vitreous Fibers  5   TOXICOLOGICAL STUDIES   34      Inhalation Studies,   35      Intratracheal Instillation,   37      Intracavitary Injection,   39      Conclusions,   39  6   EPIDEMIOLOGICAL STUDIES   41      Manufactured Vitreous Fibers,   42      Refractory Ceramic Fibers,   46      Conclusions,   48  7   EVALUATION OF THE NAVY'S EXPOSURE STANDARD   51  8   INFORMATION GAPS AND RECOMMENDATIONS FOR FUTURE RESEARCH   59     REFERENCES   63

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Review of the U.S. Navy's Exposure Standard for Manufactured Vitreous Fibers REVIEW OF THE U.S. NAVY'S EXPOSURE STANDARD FOR MANUFACTURED VITREOUS FIBERS

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Review of the U.S. Navy's Exposure Standard for Manufactured Vitreous Fibers