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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.
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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
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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
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
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
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
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