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Monitoring Human Tissues for Toxic Substances Monitoring Human Tissues for Toxic Substances Committee on National Monitoring of Human Tissues Board on Environmental Studies and Toxicology Commission on Life Sciences NATIONAL ACADEMY PRESS Washington, D.C. 1991
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Monitoring Human Tissues for Toxic Substances 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 competencies and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The National Academy of Sciences is a private, non-profit, 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. Frank Press 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. Robert M. White 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. Samuel O.Thier 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. Frank Press and Dr. Robert M.White are chairman and vice chairman, respectively, of the National Research Council. The project was supported by the U.S. Environmental Protection Agency through cooperative agreement No. CR-812547-01. Library of Congress Catalog Card No. 91–61252 International Standard Book Number 0-309-04437-5 Additional copies of this report are available from the National Academy Press, 2101 Constitution Avenue, N.W., Washington, D.C. 20418 S289 Printed in the United States of America
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Monitoring Human Tissues for Toxic Substances Committee on National Monitoring of Human Tissues JOHN C. BAILAR, III (Chairman), McGill University School of Medicine, Montreal DAVID GAYLOR, U.S. Food & Drug Administration, National Center for Toxicologic Research, Jefferson, Arkansas WILLIAM GRIZZLE, University of Alabama at Birmingham THOMAS GRUMBLY, Clean Sites, Inc., Alexandria, Virginia DAVID KALMAN, University of Washington, Seattle KATHRYN MAHAFFEY, National Institute of Environmental Health Sciences and University of Cincinnati Medical School H. B. MATTHEWS, National Institute of Environmental Health Sciences, Research Triangle Park FREDERICA PERERA, Columbia University, New York JOSEPH WAKSBERG, WESTAT, Rockville, Maryland Staff LEE R. PAULSON, Project Director CAROLYN FULCO, Staff Officer (until June 1990) NORMAN GROSSBLATT, Editor BERNIDEAN WILLIAMS, Information Specialist SHELLEY NURSE, Senior Project Assistant Sponsor: U.S. Environmental Protection Agency
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Monitoring Human Tissues for Toxic Substances Board on Environmental Studies and Toxicology GILBERT S. OMENN (Chairman), University of Washington, Seattle FREDERICK R. ANDERSON, Washington School of Law, American University JOHN C. BAILAR, III, McGill University School of Medicine, Montreal LAWRENCE W. BARNTHOUSE, Oak Ridge National Laboratory, Oak Ridge GARRY D. BREWER, Yale University, New Haven JOANNA BURGER, Nelson Laboratory, Rutgers University, Piscataway YORAM COHEN, University of California, Los Angeles JOHN L. EMMERSON, Lilly Research Laboratories, Greenfield, IN ROBERT L. HARNESS, Monsanto Agricultural Company, St. Louis ALFRED G. KNUDSON, Fox Chase Cancer Center, Philadelphia GENE E. LIKENS, The New York Botanical Garden, Millbrook PAUL J. LIOY, UMDNJ-Robert Wood Johnson Medical School, Piscataway JANE LUBCHENCO, Oregon State University, Corvallis DONALD MATTISON, University of Pittsburgh, Pittsburgh NATHANIEL REED, Hobe Sound, FL F. SHERWOOD ROWLAND, University of California, Irvine MILTON RUSSELL, University of Tennessee, Knoxville MARGARET M. SEMINARIO, AFL/CIO, Washington, DC I.GLENN SIPES, University of Arizona, Tucson WALTER J. WEBER, JR., University of Michigan, Ann Arbor Staff JAMES J. REISA, Director DAVID J. POLICANSKY, Program Director for Natural Resources and Applied Ecology ROBERT B. SMYTHE, Program Director for Exposure Assessment and Risk Reduction RICHARD D. THOMAS, Program Director for Human Toxicology and Risk Assessment LEE R. PAULSON, Manager, Toxicology Information Center
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Monitoring Human Tissues for Toxic Substances Commission on Life Sciences BRUCE M. ALBERTS (Chairman), University of California, San Francisco BRUCE N. AMES, University of California, Berkeley FRANCISCO J. AYALA, University of California, Irvine J. MICHAEL BISHOP, Hooper Research Foundation, University of California Medical Center, San Francisco MICHAEL T. CLEGG, University of California, Riverside GLENN A. CROSBY, Washington State University, Pullman FREEMAN J. DYSON, Princeton University, New Jersey LEROY E. HOOD, California Institute of Technology, Pasadena DONALD F. HORNIG, Harvard School of Public Health, Boston MARIAN E. KOSHLAND, University of California, Berkeley RICHARD E. LENSKI, University of California, Irvine STEVEN P. PAKES, Southwestern Medical School, Dallas EMIL A. PFITZER, Hoffman-LaRoche, Inc., Nutley, New Jersey THOMAS D. POLLARD, Johns Hopkins Medical School, Baltimore JOSEPH E. RALL, National Institutes of Health, Bethesda, Maryland RICHARD D. REMINGTON, University of Iowa, Iowa City PAUL G. RISSER, University of New Mexico, Albuquerque HAROLD M. SCHMECK, JR., Armonk, New York RICHARD B. SETLOW, Brookhaven National Laboratory, Upton, New York CARLA J. SHATZ, Stanford University School of Medicine, Stanford TORSTEN N. WIESEL, Rockefeller University, New York JOHN E. BURRIS, Executive Director
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Monitoring Human Tissues for Toxic Substances Preface We are exposed continually to a wide range of chemical substances. Some are known to be toxic at common exposure levels, and others might be toxic. We have special concern about man-made chemicals, which often move readily from place to place—for example, from factory smokestack to air to rain to groundwater to household water supply—and can enter our food supply, air, and soil. Data on the movement and present location of specific chemicals are remarkably sparse, but even extensive monitoring of the concentrations of chemicals in various exposure media often can fail to detect or define human health risks. There are too many chemicals, too many sources, and too many routes of exposure to rely solely on environmental monitoring. Additional problems arise when a chemical is newly recognized as important but was not included in past programs to monitor human exposure, and still other problems arise when the relationships between exposure levels and concentrations in the human body are unknown. Those concerns make it important to determine the concentrations of specific chemicals in human tissues. The National Human Monitoring Program (NHMP) was established in 1967 by the U.S. Public Health Service and since 1970 has been housed in the Environmental Protection Agency. In response to a request from EPA, this report of the National Research Council’s Committee on National Monitoring of Human Tissues evaluates the current program; identifies important scientific, technical, and programmatic issues; and makes recommendations regarding the design of the program and use of its products. The program had not been reviewed in this way at any earlier time, and we believe that it had become a textbook example of a program that was well intentioned, was focused on a critical issue, was managed by staff competent in their disciplines, but was in need of a hard look by external peer review. The program was not large in the overall scheme of
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Monitoring Human Tissues for Toxic Substances things, and peer review would not have been difficult; but by the time our committee was asked to undertake this review, the accumulated problems in the program had reached a stage of crisis, even to the point of doubt about whether the NHMP should be continued. One is moved to wonder how many other small, critically important scientific programs might profit from peer review, and not just at EPA. The members of our committee were expert, in various combinations, in biostatistics, toxicology, exposure assessment and epidemiology, chemistry, pharmacokinetics, risk assessment, public policy, survey statistics, data base management and tissue archiving, and biologic markers. Before writing this report, the committee convened a workshop in January 1989 to obtain the opinions of program officials and experts in fields relevant to tissue monitoring, environmental monitoring, and risk assessment. These officials and experts helped our committee identify the potential goals and uses of a national program and study in detail the operations and technical methods of the NHMP. Users and potential users of tissue monitoring data also made important contributions to the workshop. During our work, the committee was repeatedly surprised by the gaps between the needs for data from human tissue monitoring and the limited scope of current activities to fill those needs. Other countries, most notably Germany, have far more extensive human tissue monitoring activities, and the data are used widely for many purposes. In the United States, the right kind of program could generate data of great value to numerous and diverse users. Thus, our main conclusion is that a substantially new program, designed with an appreciation of the strengths and weaknesses of the old, should be implemented forthwith. The typical committee process often is criticized, but in this case, things worked very well indeed. The members of our committee, all strong and independent professionals, rolled up their sleeves and settled down to work together at our very first meeting. The National Research Council staff were fully effective members of the team. We could not have produced this report without the support of Lee Paulson and Carolyn Fulco; our efforts and deliberations were greatly aided by Jim Reisa, director of the Board on Environmental Studies and Toxicology; and others, especially Karen Hulebak and Shelley Nurse, helped in critical ways. We also profited from the continuing interest and cooperation of present NHMP staff at EPA, its contractors, and many potential users of the data. John C.Bailar, III Chairman
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Monitoring Human Tissues for Toxic Substances Contents EXECUTIVE SUMMARY 1 1 INTRODUCTION 21 Background, 21 Charge to the Committee, 22 Environmental and Public Health Rationale for Monitoring Chemicals in Human Tissues, 23 Relationship of Tissue Monitoring to EPA Program Priorities, 25 Goals and Potential Uses of a National Program to Monitor Human Tissues, 26 2 REVIEW OF THE NATIONAL HUMAN ADIPOSE TISSUE SURVEY AND SELECTED PROGRAM ALTERNATIVES 29 Development of the Program, 29 Existing Programs as Possible Alternatives to the National Human Adipose Tissue Survey, 36 Summary and Recommendations, 42 3 TOXICOLOGIC ISSUES 45 Introduction, 45 Relation Between Environmental Monitoring and Tissue Monitoring, 45 Relevance of Human Tissue Monitoring to Risk Assessment, 47
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Monitoring Human Tissues for Toxic Substances Choice of Tissues to Monitor, 57 Summary and Recommendations, 67 4 SAMPLING METHODS 71 Introduction, 71 Some Features for Sampling in a Continuing Population Survey, 72 Commonly Required Compromises in Sampling Methods, 74 The National Human Adipose Tissue Survey Sample, 77 Improvements That Are Possible Without Changing Basic Data Collection Methods, 82 Computation of Sampling Errors, 91 Criticisms of NHATS Statistical Sampling Methods, 91 Summary and Recommendations, 97 5 COLLECTION, SHORT-TERM STORAGE, AND ARCHIVING OF TISSUES 99 Introduction, 99 Collection, 99 Short- and Long-Term Storage, 101 Additional Issues for Consideration, 103 Status of the NHATS Archive, 107 Summary and Recommendations, 109 6 CHEMICAL ASSAY OF SPECIMENS 111 Introduction, 111 Major Features of a Program for Chemical Analysis of Tissues for Population-Based Surveillance of Exposures, 112 Practical Limitations and Compromises, 122 Current and Previous Analytic Practices of the NHATS Program, 124 Summary and Recommendations, 139 7 PROGRAM DESIGN AND MANAGEMENT ISSUES 143 Introduction, 143 Administrative and Agency Issues, 143 Implementation and Operational Issues, 154 Analysis and Reporting of Data, 157 Cooperation and Information Transfer with Other Organizations, 161
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Monitoring Human Tissues for Toxic Substances Transition, 162 Summary and Recommendations, 163 REFERENCES 167 APPENDIX A: WORKSHOP AGENDA 181 APPENDIX B: WORKSHOP PARTICIPANTS 185 APPENDIX C: SUMMARY OF WORKSHOP 187 APPENDIX D: THE NATIONAL HEALTH AND NUTRITION EXAMINATION SURVEY 201 APPENDIX E: FOREIGN ENVIRONMENTAL MONITORING PROGRAMS USING HUMAN TISSUES OR TISSUE SPECIMEN BANKING 209
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