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Occu Rational Health and Safety in the Care and Use of Research Animals Committee on Occupational Safety and Health in Research Animal Facilities Institute of Laboratory Animal Resources Commission on Life Sciences National Research Council NATIONAL ACADEMY PRESS Washington, DC 1997

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NATIONAL ACADEMY PRESS 2101 Constitution Avenue, NW Washington, DC 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, National Academy of Engineering, and Institute of Medicine. The members of the commit- tee responsible for the report were chosen for their special competences and with regard for appropri- ate 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 Sci- ences, National Academy of Engineering, and Institute of Medicine. This study was supported under contract number NO1-RR-2-2118 by the National Center for Research Resources (NCRR), National Institutes of Health, Department of Health and Human Ser- vices (DHHS), which served as the lead agency for DHHS funding received from the Centers for Disease Control and Prevention, National Cancer Institute, National Institute on Aging, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Environmental Health Sciences, National Insti- tute of General Medical Sciences, National Institute of Neurological Disorders and Stroke, and the Office for Protection from Research Risks. NCRR also served as the lead agency for receipt of funding from the Agricultural Research Service, U.S. Department of Agriculture, and the Veterans Administration. Financial support was also provided by Research Resources, Merck Research Labs. Core support is provided to the Institute of Laboratory Animal Resources by the Comparative Medicine Program, National Center for Research Resources, National Institutes of Health, through grant number 5P40RR0137; the National Science Foundation through grant number BIR-9024967; the U.S. Army Medical Research and Development Command, which serves as the lead agency for combined U.S. Department of Defense funding also received from the Human Systems Division of the U.S. Air Force Systems Command, Armed Forces Radiobiology Research Institute, Uniformed Services University of the Health Sciences, and U.S. Naval Medical Research and Development Command, through grant number DAMD17-93-J-3016; the American Cancer Society through grant number RC-1-34; and the American College of Laboratory Animal Medicine. Any opinions, findings, and conclusions or recommendations expressed in this publication do not necessarily reflect the views of DHHS or other sponsors, nor does the mention of trade names, commercial products, or organizations imply endorsement by the U.S. government or other sponsors. Occupational Health and Safety in the Care and use of Research Animals is available from the National Academy Press, 2101 Constitution Avenue, NW, Box 285, Washington DC 20055 1-800-624-6242; 202-334-3313 (in the Washington Metropolitan Area); http://www.nap.edu Library of Congress Cataloging-in-Publication Data Occupational health and safety in the care and use of research animals / Committee on Occupational Safety and Health in Research Animal Facilities, Institute of Laboratory Animal Resources, Commission on Life Sciences, National Research Council. p. cm. Includes bibliographical references and index. ISBN 0-309-05299-8 (pbk.) 1. Laboratory animal technicians Health risk assessment. 2. Animal health technicians Health risk assessment. 3. Occupational diseases Prevention. I. Institute of Laboratory Animal Resources (U.S.). Committee on Occupational Safety and Health in Research Animal Facilities. RC965.A6023 1997 363.11'9619 dc21 Copyright 1997 by the National Academy of Sciences. All right reserved. Printed in the United States of America 97-4794

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COMMITTEE ON OCCUPATIONAL SAFETY AND HEALTH IN RESEARCH ANIMAL FACILITIES W. Emmett Barkley (Chair), Laboratory Safety, Howard Hughes Medical Institute, Chevy Chase, Maryland Rebecca Bascom, University of Maryland School of Medicine, Baltimore, Maryland Robert K. Bush, Allergy Section, University of Wisconsin, and William S. Middleton VA Hospital, Madison, Wisconsin Diane O. Fleming, The Johns Hopkins University, Baltimore, Maryland Peter I. Gerone, Tulane Regional Primate Research Center, Tulane University Medical Center, Covington, Louisiana Janet C. Gonder, Baxter Healthcare Corporation, Round Lake, Illinois A. Wallace Hayes, The Gillette Company, Boston, Massachusetts Julia K. Hilliard, Department of Virology and Immunology, Southwest Foundation for Biomedical Research, San Antonio, Texas Christian E. Newcomer, Division of Laboratory Animal Medicine, School of Medicine, The University of North Carolina, Chapel Hill, North Carolina James H. Stewart, Harvard University and Data Chem Software, Westboro, Massachusetts Wayne R. Thomann, Department of Occupational and Environmental Safety, Duke University, Durham, North Carolina Stay Thomas L. Wolfle, Program Director Ralph Dell, Visiting Scientist Amanda Hull, Project Assistant (through 1995) Cheryl Mitchell, Project Assistant Carol M. Rozmiarek, Project Assistant Norman Grosshlatt, Editor . . .

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INSTITUTE OF LABORATORY ANIMAL RESOURCES COUNCIL John L. VandeBerg (Chair), Southwest Foundation for Biomedical Research, San Antonio, Texas Christian R. Abee, University of South Alabama, Mobile, Alabama Muriel T. Davisson, The Jackson Laboratory, Bar Harbor, Maine Bennett Dyke, Southwest Foundation for Biomedical Research, San Antonio, Texas Neal L. First, University of Wisconsin, Madison, Wisconsin Gerald F. GeLhart, University of Iowa, Iowa City, Iowa James W. Glosser, Massillon, Ohio John P. Hearn, Wisconsin Regional Primate Research Center, Madison, Wisconsin Margaret S. Landi, SmithKline Beecham Pharmaceuticals, King of Prussia, Pennsylvania Charles R. McCarthy, Kennedy Institute of Ethics, Georgetown University, Washington, DC Robert }. Russell, Harlan Sprague Dawley, Indianapolis, Indiana Richard C. Van Sluyters, University of California, Berkeley, California John G. Vanderbergh, North Carolina State University, Raleigh, North Carolina Peter A. Ward, University of Michigan Medical School, Ann Arbor, Michigan Thomas D. Pollard, The Salk Institute for Biological Studies, La Jolla, California (ex officio member) Staff Thomas L. Wolfle, Program Director Mara L. Glenshaw, Research Assistant Cheryl Mitchell, Project Assistant Carol M. Rozmiarek, Project Assistant The Institute of Laboratory Animal Resources (ILAR) was founded in 1952 under the auspices of the National Research Council. A component of the Com- mission on Life Sciences, ILAR develops guidelines and disseminates informa- tion on the scientific, technological, and ethical use of animals and related bio- logical resources in research, testing, and education. ILAR promotes high-quality, humane care of animals and the appropriate use of animals and alternatives. ILAR functions within the mission of the National Academy of Sciences as an adviser to the federal government, the biomedical research community, and the public. V

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COMMISSION ON LIFE SCIENCES Thomas D. Pollard (Chairman), The Salk Institute for Biological Studies, La Jolla, California Frederick R. Anderson, Cadwalader, Wickersham & Taft, Washington, D.C. John C. Bailar III, University of Chicago, Chicago, Illinois Paul Berg, Stanford University School of Medicine, Stanford, California John E. Burris, Marine Biological Laboratory, Woods Hole, Massachusetts Sharon L. Dunwoody University of Wisconsin, Madison, Wisconsin Ursula W. Goodenough, Washington University, St. Louis, Missouri Henry W. Heikkinen, University of Northern Colorado, Greeley, Colorado Hans I. Kende, Michigan State University, East Lansing, Michigan Susan E. Leeman, Boston University School of Medicine, Boston, Massachusetts Thomas E. Lovejoy, Smithsonian Institution, Washington, D.C. Donald R. Mattison, University of Pittsburgh, Pittsburgh, Pennsylvania Joseph E. Murray, Wellesley Hills, Massachusetts Edward E. Penhoet, Chiron Corporation, Emeryville, California Emil A. Pfitzer, Research Institute for Fragrance Materials, Inc., Hackensack, New Jersey Malcolm C. Pike, University of Southern California Comprehensive Cancer Center, Los Angeles, California Henry C. Pitot III, McArdle Laboratory for Cancer Research, Madison, Wisconsin Jonathan M. Samet, The Johns Hopkins University, Baltimore, Maryland Charles Stevens, The Salk Institute for Biological Studies, La Jolla, California John L. VandeBerg, Southwest Foundation for Biomedical Research, San Antonio, Texas Staff: Paul Gilman, Executive Director v

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The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distin- guished 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 Alberts is president of the National Acad- emy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the Na- tional 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 established 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 National Academy of Engineering in the conduct of their services to the government, the public, and the scientific and engineering communities. The Council is admin- istered jointly by both Academies and the Institute of Medicine. Dr. Bruce Alberts and Dr. William A. Wulf are chairman and vice-chairman, respectively, of the National Research Council.

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Preface Occupational health and safety has long been a priority in the nation's re- search enterprise and of the National Research Council (NRC) of the National Academy of Engineering and the National Academy of Sciences. Over the last 2 decades, the NRC has provided substantive guidance in environmental health and safety to laboratory workers, managers, and government policy-makers through four major reports: Prudent Practices for Handling Hazardous Chemicals in Laboratories (1981), Prudent Practices for Disposal of Chemicals from Labora- tories (1983), Biosafety in the Laboratory: Prudent Practices for the Handling and Disposal of Infectious Materials (1989), and Prudent Practices in the Labo- ratory: Handling and Disposing of Chemicals (1995) which consolidated and extensively revised the 1981 and 1983 reports. This tradition has now been extended to address occupational health and safety issues associated with the care and use of laboratory animals. The Interagency Research Animal Committee (IRAC), composed of repre- sentatives of federal agencies that use or regulate the use of animals in research, asked the NRC to conduct a study and produce a report that would provide guidance for protecting the health and safety of workers who care for and use research animals. The need for such guidance was based both on the recognition of the broad array of occupational hazards in the specialized workplace of the animal research facility and on the absence of authoritative guidance that institu- tions could use to develop appropriate occupational health and safety programs within their animal research facilities. The IRAC and NRC considered this study particularly important because grantees of the US Public Health Service are required to address the need for an occupational health program as recommended

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. . . vile PREFACE in the Guide for the Care and Use of Laboratory Animals and particularly timely because the Guide was scheduled for revision. The NRC appointed the Commit- tee on Occupational Safety and Health of Personnel in Research Animal Facili- ties in January 1993. The study was conducted under the auspices of the Institute of Laboratory Animal Resources (ILAR) of the Commission on Life Sciences. The committee was charged to provide guidelines for the development of occupational health and safety programs that would be suitable for all institutions that use research animals. Specific recommendations were requested of the committee on several relevant issues, including the need for periodic physical examinations, the value of serum banking, and who should be included in the animal research institution's occupational health and safety program. This report differs considerably from its predecessors. Although it affirms prudent practices developed in the previous studies, the committee's approach has been to address the way in which prudent practices can best be incorporated into the animal care and use programs of research institutions. When hazards associated with laboratory research are viewed in the context of the animal facil- ity, different strategies might be appropriate for achieving a safe and healthful workplace. A new set of workers, who might be less informed of research hazards, could become exposed to potentially hazardous experimental agents under circumstances quite different from the laboratory. The safety knowledge and expertise of the responsible laboratory worker might not be easily transfer- able to this new setting. And the use of research animals introduces new occupa- tional health concerns, such as the risks of zoonoses and allergies to animals. In the course of preparing this report, the committee met with a large number of specialists as an important part of its data-gathering. The committee hosted workshops in Washington, DC, and Irvine, California, with occupational health professionals; participated in the Forum on Occupational Health and Safety spon- sored by the American College of Laboratory Animal Medicine; and conducted seminars at meetings of the American Association for Laboratory Animal Sci- ence, Public Responsibility in Medicine and Research (PRIM&R), and the Ap- plied Research Ethics National Association (ARENA). Many people participated in those sessions and contributed substantially to the formulation of the committee's recommendations. To each of them the committee is greatly in- debted. Special recognition is in order for the important and continuing assis- tance provided by Ralph Dell, Columbia University; Alan Ducatman, West Vir- ginia University School of Medicine; Tom Ferguson, University of California, Davis; Suzi Goldmacher, University of California, San Francisco; George Jack- son, Duke University; Thomas McBride, US Department of Energy; Albert E. New, Association for Assessment and Accreditation of Laboratory Animal Care, International; Jonathan Richmond and Margaret Tipple, Centers for Disease Con- trol and Prevention; James Schmitt, National Institutes of Health; and Ellison Wittles, Baylor University College of Medicine. Many letters of interest and support were received from people who struggle

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PREFACE MIX with occupational health issues at their institutions. They reminded us not to forget the small institutions, not to create costly bureaucracy, to help with the meaning of "substantial animal contact" in defining those who should be in- cluded in institutional occupational health and safety programs, and to help in determining needs for serum banking and other important parts of their occupa- tional health programs. Their letters constituted a tremendous incentive to the committee and a constant reminder of the array of problems for which the report would be consulted. We also want to acknowledge the contributions of the many individuals who willingly agreed to review our work. Their burden was our benefit as they thoughtfully improved the quality of this report. The committee recognizes that this report will likely be revised in the future. It has been our intent to provide basic concepts and a valid foundation from which many models of successful occupational health and safety programs will emerge. Future revisions will benefit from this acquired experience. So we encourage readers who have evidence to support improved procedures or recom- mendations or who detect errors of omission or commission in this report to send their suggestions to the Institute of Laboratory Animal Resources, National Re- search Council, National Academy of Sciences, 2101 Constitution Avenue, NW, Washington, DC 20418. The committee extends its appreciation to the sponsors of this report; to Norman Grossblatt for editing the manuscript; to James Glosser for his encour- agement and wise counsel; to Carol Rozmiarek for her skillful support at each of the committee's meetings and for coordinating the great flow of information to and from committee members; to Amanda Hull for her steadfast assistance and polite reminders of our self-inflicted deadlines; and to Thomas Wolfle for his thoughtful nurturing, extraordinary tolerance, hard work, and firm belief that our good intentions would ultimately prevail. Emmett Barkley, Chair Committee on Occupational Safety and Health in Research Animal Facilities

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Contents INTRODUCTION, OVERVIEW, AND RECOMMENDATIONS Introduction, 1 Overview, 3 Recommendations, 7 PROGRAM DESIGN AND MANAGEMENT Program Goal, 11 Diversity, 1 1 Basic Concepts, 13 Accountability and Responsibility, 15 Institutional Activities and Their Interactions, 18 Management Style and Structure, 23 Getting Started, 23 11 3 PHYSICAL, CHEMICAL, AND PROTOCOL-RELATED HAZARDS 32 Physical Hazards, 32 Hazards Associated with Experimental Protocols, 43 ALLERGENS Mechanisms of Allergic Reactions, 53 Specific Animals That Can Provoke Allergic Reactions, 54 Preventive Measures and Interventions, 60 Evaluation of the Allergic Worker, 63 Anaphylaxis, 64 x~ 51

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xt! 5 ZOONOSES Viral Diseases, 66 Rickettsial Diseases, 81 Bacterial Diseases, 85 Protozoal Diseases, 95 Fungal Diseases, 99 Helminth Infections, 101 Arthropod Infestations,101 6 PRINCIPAL ELEMENTS OF AN OCCUPATIONAL HEALTH AND SAFETY PROGRAM Administrative Procedures, 107 Facility Design and Operation, 107 Exposure Control Methods, 108 Education and Training, 114 Equipment Performance, 116 Information Management, 118 Emergency Procedures, 120 Program Evaluation, 121 7 OCCUPATIONAL HEALTH-CARE SERVICES Federal Requirements and Guidelines for Occupational Health-Care Services, 124 Assessment of Health Risks, 125 Responsibilities of an Occupational Health-Care Service, 125 Activities of an Occupational Health-Care Service, 129 Program Evaluation, 133 REFERENCES INDEX CONTENTS 65 106 123 135 147