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Assessment of Technologies for Determining Cancer Risks from the Environment

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Assessment of Technologies for Determining Cancer Risks from the Environment Assessment of Technologies for Determining Cancer Risks From the Environment June 1981 NTIS order #PB81-235400 Library of Congress Catalog Card Number 81-600081 For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402 Foreword Congressional interest in cancer is long standing and continuing. Programs in basic cancer research, and in treatment and prevention of the disease are now complemented by some two dozen laws directed at reducing exposures to cancer-causing substances. This report examines the technologies used to gather and analyze information about cancer in our society, as well as the ways in which those technologies affect and are affected by the public health and en- vironmental legislative mandates. The report discusses the strengths and weaknesses of data sources used for determining trends in cancer occurrence and mortality, and reviews estimates of the contribution of various factors—behaviors and exposures—associated with cancer in this country. Evidence linking to- day’s cancers with past carcinogenic influences has come mainly from epidemiology, which continues to scrutinize aspects of the American lifestyle, for possible associations with cancer. Congressional mandates intended to shield people from new and already-present car- cinogens have heightened the need for methods to identify such harmful agents before they have an impact on human health. Laboratory testing technologies currently used to determine the carcinogencity of substances, and technologies that may become important in the near fu- ture are discussed and evaluated, The assessment examines the use of extrapolation techniques for estimating human carcinogenic risks from test-derived data; the advantages and disadvan- tages of the available extrapolation models; and the ultimate use of these techniques in setting standards for controlling exposures under diverse legislation. The report then looks at the prob- lems of decisionmaking in the face of the often-great uncertainties accompanying scientific find- ings and the proposals for regulatory reform that have grown out of concern for these issues. In preparing the full report, OTA staff consulted with members of the advisory panel for the study, with contractors who prepared material for the assessment, and with other knowledgeable persons in environmental organizations, Government, industry, labor orga- nizations, research institutions, and universities. A draft of the final report was reviewed by the advisory panel, chaired by Dr. Norton Nelson, the OTA Health Program Advisory Committee, chaired by Dr. Sidney S. Lee, and by approximately 80 other individuals and groups. We are grateful for their assistance and that of many other people who assisted and advised in the preparation of this report. ● #✎ /f+// JOHN H. GIBBONS Director . 111 Assessment of Technologies for Determining Cancer Risks From the Environment Advisory Panel Norton Nelson, Panel Chairman Department of Environmental Medicine, New York University Medical School David Axelrod Brian MacMahon Commissioner of Health Chairman, Epidemiology State of New York Department Harvard University School of Public Health Peter A. A. Berle Berle, Butzel, Kass, and Case Robert A. Neal President Theodore L. Cairns Chemical Industry Institute E. I. DuPont de Nemours & Co., of Toxicology Inc. (retired) Vaun A. Newill Paul F. Deisler, Jr. Director, Research and Vice President, Health, Safety Environmental Health Division and Environment Exxon Corp. Shell Oil Co. William J. Nicholson George S. Dominguez Department of Community Director of Government Medicine Relations Mt. Sinai School of Medicine CIBA-Geigy R. Talbot Page David Doniger California Institute of Natural Resources Defense Technology Council Margaret Seminario A. Myrick Freeman Department of Occupational Professor of Economics Safety and Health Bowdoin College American Federation of Labor/ Robert Harris Congress of Industrial Environmental Defense Fund Organizations Priscilla W. Laws Alice S. Whittemore Professor of Physics Division of Epidemiology Dickinson College Stanford University School of Medicine Mark Lepper Vice President for Evaluation Michael Wright Rush-Presbyterian Medical Safety and Health Department School, St Lukes Medical Center United Steelworkers of America Assessment of Technologies for Determining Cancer Risks From the Environment OTA Project Staff Joyce C. Lashof, Assistant Director, OTA Health and Life Sciences Division H. David Banta, Health Program Manager Michael Gough, Project Director Robert J. Fensterheim, * Research Associate Hellen Gelband, * Research Associate Virginia Cwalina, Administrative Assistant Shirley Ann Gayheart, Secretary Nancy L. Kenney, Secretary Martha Ingram Finney, * Editor Other Contributing Staff Barbara Lausche, Senior Analyst Elizabeth Williams, Senior Analyst Contractors Richard Doll, Oxford University Richard Pete, Oxford University Michael Baram, Bracken and Baram, Boston, Mass. Roy Albert, New York University Medical School William Rowe, American University Clement Associates, Inc., Washington, D.C. OTA Publishing Staff John C. Holmes, Publishing Officer John Bergling Kathie S. Boss Debra M. Datcher Joe Henson ● OTA contract personnel, Contents Page 1. Summary . 3 2. Cancer Incidence and Mortality . 31 3. Factors Associated With Cancer . 65 4. Methods for Determining and Identifying Carcinogens . .............113 5. Extrapolation From Study-Generated Data to Estimates of Human Risk .157 6. Approaches to Regulating Carcinogens. .. ...175 Appendixes A. A Comparison of the National Institute’s and the International Agency for Research on Cancer’s Evaluation of Bioassay Results . 211 B. Unreasonable Risk . 215 C. Abbreviations and Glossary of Terms. .. ....221 References. ........227 vii 1. Summary — Contents ● ✎☛✎✎☛✎ 3 ● ☛✎✎✎✎☛ 3 ● ☛☛☛✎☛☛ 6 .. .*.*. 6 I ., ****. 7 t ● ☛☛☛✎☛☛ 10 ✎☛ ☛✎☛✎☛ 10 ● ☛☛✎✎✎✎ 11 ● ☛☛☛☛☛✎ 11 ● ..0... 12 I . 13 . 14 . 15 .* .**.. 15 . 17 ● ✎✎✎☛☛☛ 18 / ✎ ✎ ✎ ✎ ✎ ✎ ✎ 18 ✎✎ ✎☛☛✎✎ 19 1. Mortality From Major Cancer Sites inthe I.Jnited States,1978, All Races . 4 2. Summary of Cancer-Associated Environmental Factors . 8 *. / 1 Summary Cancer occupies center stage in American Cancer is a collection of about 200 diseases concern about disease because of its toll in lives, grouped together because of their similar suffering, and dollars. It strikes one out of four growth processes. Each cancer, regardless of the Americans, kills one out of five, and as the part of the body it affects, is believed to second-leading cause of death, following heart originate from a single “transformed” cell. A disease, killed over 400,000 people in the United transformed cell is unresponsive to normal con- States in 1979. According to estimates from the trols over growth, and its progeny may grow National Center for Health Statistics (NCHS), and multiply to produce a tumor. Studies in cancer accounted for about 10 percent of the human populations and in laboratory animals Nation’s total cost of illness in 1977. These num- have linked exposures to certain substances with bers are distressing, but the impacts of cancer cancer. This knowledge of cancer’s origins has extend beyond the numbers of lives taken and led to the conclusion that preventing interac- dollars spent. The human suffering it causes tions between cancer-causing substances and touches almost everyone. humans can reduce cancer’s toll. CANCER AND “ENVIRONMENT” Studies over the last two decades yielded a the goal of reducing cancer. This study is in- variety of statements that 60 to 90 percent of tended to illuminate the debates about the im- cancer is associated with the environment and portance of environmental factors in cancer oc- therefore is theoretically preventable. As it was currence, the laws that require actions to reduce used in those statements and is used in this exposures to cancer-causing substances (car- report, “environment” encompasses anything cinogens), and describes: that interacts with humans, including sub- ● what is known about the occurrence of stances eaten, drunk, and smoked, natural and cancer and death from cancer in the United medical radiation, workplace exposures, drugs, States; aspects of sexual behavior, and substances pres- . methods to identify cancer-causing sub- ent in the air, water, and soil. Unfortunately, stances, exposures, and behaviors; ● the statements were sometimes repeated with methods to estimate the amount of cancer “environment” used to mean only air, water, which may result from a particular be- and soil pollution. havior or exposure; Relating exposures and behaviors to cancer ● Federal laws that provide for regulatory occurrence is a first step in cancer prevention. control of carcinogenic exposures; and Once carcinogenic influences are identified, ef- ● options for Congress. forts to control them can be undertaken toward CANCER MORTALITY AND INCIDENCE Nationwide mortality data are used to an- doubt, the number of Americans dying from swer questions about the number of deaths cancer has increased during the last century. caused by cancer in the United States. Without Paradoxically, a major part of this increase re- 3 — ● 4 Technologies for Determining Cancer Risks From the Environment suited from improvements in public health and proportion of people in defined age classes who medical care. In yearn past, infectious diseases have developed or died from cancer, and are un- killed large numbers of people in infancy and affected by changes in the age structure of the during childhood.
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