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Monitoring Human Tissues for Toxic Substances (1991)

Chapter: Front Matter

Suggested Citation:"Front Matter." National Research Council. 1991. Monitoring Human Tissues for Toxic Substances. Washington, DC: The National Academies Press. doi: 10.17226/1787.
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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

Suggested Citation:"Front Matter." National Research Council. 1991. Monitoring Human Tissues for Toxic Substances. Washington, DC: The National Academies Press. doi: 10.17226/1787.
×

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

Suggested Citation:"Front Matter." National Research Council. 1991. Monitoring Human Tissues for Toxic Substances. Washington, DC: The National Academies Press. doi: 10.17226/1787.
×

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

Suggested Citation:"Front Matter." National Research Council. 1991. Monitoring Human Tissues for Toxic Substances. Washington, DC: The National Academies Press. doi: 10.17226/1787.
×

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

Suggested Citation:"Front Matter." National Research Council. 1991. Monitoring Human Tissues for Toxic Substances. Washington, DC: The National Academies Press. doi: 10.17226/1787.
×

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

Suggested Citation:"Front Matter." National Research Council. 1991. Monitoring Human Tissues for Toxic Substances. Washington, DC: The National Academies Press. doi: 10.17226/1787.
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Suggested Citation:"Front Matter." National Research Council. 1991. Monitoring Human Tissues for Toxic Substances. Washington, DC: The National Academies Press. doi: 10.17226/1787.
×

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

Page viii Cite
Suggested Citation:"Front Matter." National Research Council. 1991. Monitoring Human Tissues for Toxic Substances. Washington, DC: The National Academies Press. doi: 10.17226/1787.
×

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

Suggested Citation:"Front Matter." National Research Council. 1991. Monitoring Human Tissues for Toxic Substances. Washington, DC: The National Academies Press. doi: 10.17226/1787.
×
   

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

Suggested Citation:"Front Matter." National Research Council. 1991. Monitoring Human Tissues for Toxic Substances. Washington, DC: The National Academies Press. doi: 10.17226/1787.
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Suggested Citation:"Front Matter." National Research Council. 1991. Monitoring Human Tissues for Toxic Substances. Washington, DC: The National Academies Press. doi: 10.17226/1787.
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The National Human Monitoring Program (NHMP) identifies concentrations of specific chemicals in human tissues, including toxicologic testing and risk assessment determinations. This volume evaluates the current activities of the NHMP; identifies important scientific, technical, and programmatic issues; and makes recommendations regarding the design of the program and use of its products.

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