Occupational Health and Safety in the Care and Use of Nonhuman Primates

Committee on Occupational Health and Safety in the Care and Use of Nonhuman Primates

Institute for Laboratory Animal Research

Division on Earth and Life Studies

NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C. www.nap.edu



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Occupational Health and Safety in the Care and Use of Nonhuman Primates Committee on Occupational Health and Safety in the Care and Use of Nonhuman Primates Institute for Laboratory Animal Research Division on Earth and Life Studies NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 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 competences and with regard for appropriate balance. This study was supported by contract number N01-OD-4-2139, Task Order No. 73 and purchase order number 263-MD-005750 from the National Institutes of Health (NIH), Department of Health and Human Services (DHHS); grant number R13RR15165 from the National Center for Research Resources (NCRR), NIH, DHHS; purchase order number 0000065415 from the National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC), DHHS; purchase order number 0000166565 from the National Institute of Occupational Safety and Health, CDC, DHHS; contract number 223-93-1025 from the Food and Drug Administration, DHHS. Financial support was also provided by the Association of Primate Veterinarians, Merck Research Laboratories, and the Elizabeth R. Griffin Foundation. Core support for the Institute for Laboratory Animal Research is provided by the Division of Comparative Medicine, NCRR, NIH through grant number P40RR11611; the National Science Foundation through grant number DBI-9805555; the US Army Medical Research and Development Command, which serves as the lead agency for combined US Department of Defense funding also received from the Human Systems Division of the US Air Force Systems Command, Armed Forces Radioiology Research Institute, Uniformed Services University of the Health Sciences, and US Naval Medical Research and Development Command through grant number DAMD-98-1-8275; and Merck Research Laboratories. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number 0-309-08914-X (Book) International Standard Book Number 0-309-50779-0 (PDF) Library of Congress Catalog Card Number 200310660 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu Copyright 2003 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine The National Academy of Sciences is a private, nonprofit, 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. Bruce M. Alberts 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. Wm. 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. Harvey V. Fineberg 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. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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COMMITTEE ON OCCUPATIONAL HEALTH AND SAFETY IN THE CARE AND USE OF NONHUMAN PRIMATES Frederick A. Murphy(Co-Chairman), University of California - Davis, School of Veterinary Medicine, Davis, California Jeffrey A. Roberts(Co-Chairman), University of California - Davis, California National Primate Research Center, Davis, California Kathryn A.L. Bayne, Association for Assessment and Accreditation of Laboratory Animal Care International, Rockville, Maryland James L. Blanchard, Tulane National Primate Research Center, Covington, Louisiana Thomas J. Ferguson, University of California - Davis, Davis, California Lisa J. Flynn, US Public Health Service Commissioned Corps, US Food and Drug Administration, Rockville, Maryland Jack Geissert, Wyeth BioPharma Division, Andover, Massachusetts Julia K. Hilliard, Georgia State University, Department of Biology, Atlanta, Georgia Michael Kiley, US Department of Agriculture, Beltsville, Maryland Clarence J. Peters, University of Texas Medical Branch, Department of Microbiology, Immunology, and Pathology, Galveston, Texas Benjamin J. Weigler, Fred Hutchinson Cancer Research Center, Seattle, Washington Consultant David S. Davenport, Michigan State University, Kalamazoo, Michigan Staff Joanne Zurlo, Director Marsha Barrett, Project Assistant Kathleen Beil, Administrative Assistant Ralph Dell, Associate Director Norman Grossblatt, Editor Jennifer Obernier, Program Officer Susan Vaupel, Editor

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INSTITUTE FOR LABORATORY ANIMAL RESEARCH COUNCIL Peter A. Ward(Chair), University of Michigan Medical School, Department of Pathology, Ann Arbor, Michigan Stephen W. Barthold, University of California- Davis, Center for Comparative Medicine, Davis, California Rosemary W. Elliott, Roswell Park Cancer Institute, Department of Molecular and Cellular Biology, Buffalo, New York Michael F. Festing, University of Leicester, MRC Toxicology Unit, Leicester, United Kingdom Janet C. Gonder, Pinehurst, North Carolina Coenraad F.M. Hendriksen, National Institute of Public Health and the Environment, Central Animal Laboratories, Bilthoven, Netherlands Jay R. Kaplan, Wake Forest University School of Medicine, Department of Comparative Medicine, Winston-Salem, North Carolina Hilton J. Klein, Merck Research Laboratories, Department of Laboratory Animal Resources, West Point, Pennsylvania William Morton, University of Washington, National Primate Research Center, Seattle, Washington Randall J. Nelson, University of Tennessee, Department of Anatomy and Neurobiology, Memphis, Tennessee Emilie F. Rissman, University of Virginia, Department of Biochemistry and Molecular Genetics, Charlottesville, Virginia Lilly-Marlene Russow, Purdue University, Department of Philosophy, West Lafayette, Indiana William S. Stokes, National Institute of Environmental Health Science, Animal and Alternative Resources, Research Triangle Park, North Carolina Michael K. Stoskopf, North Carolina State University, College of Veterinary Medicine, Raleigh, North Carolina Thomas Wolfle, Cambridge, Maryland Staff Joanne Zurlo, Director Marsha Barrett, Project Assistant Kathleen Beil, Administrative Assistant Ralph Dell, Associate Director Jennifer Obernier, Program Officer Susan Vaupel, Editor of ILAR Journal

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Preface The publication in 1997 of the Institute for Laboratory Animal Research (ILAR) report Occupational Health and Safety in the Care and Use of Research Animals provided an excellent reference for the development of occupational health and safety programs in the animal research setting. The diversity of species and potential hazards encountered in animal care and use programs required a broad view of many topics and by necessity, limited the depth of any particular subjects in the report. The care and use of nonhuman primates in the research setting presents a number of challenges to facility management. These challenges include specific hazards unique to some primate species and the need for guidance in risk assessment and management. This report was generated in response to that need and to specific events that took place in the same year as the first ILAR report. On October 29, 1997, a research assistant at Yerkes Regional Primate Research Center was splashed in the eye with an unidentified body fluid from a nonhuman primate and later died from encephalitis caused by B virus (formerly called Cercopithecine herpesvirus 1). This incident confirmed the suspicion that B virus infection can be acquired through mucosal contact, in addition to the more common exposures through bites, scratches, and needle sticks. Following the incident at Yerkes, the National Institute for Occupational Safety and Health (NIOSH) conducted a limited review of policies and procedures related to working with nonhuman primates at various National Primate Research Centers. NIOSH recommended that “goggles and face shields be worn when working with

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nonhuman primates.” Many investigators and caretakers expressed concern that these protective devices would obstruct vision and would be difficult to wear, leading to an increase in bites, scratches, and needles sticks due to decreased vision. There was also the concern that workers would not adhere to the NIOSH recommendation. Therefore, one specific intent of this report has been to address these recommendations and concerns. Infectious agents represent only one of the hazards present in nonhuman-primate animal care and use programs. The size, strength, and intelligence of many primate species can result in unique hazards associated with animal care and management. In addition, these same taxonomic attributes may require heavy caging and support equipment that can present ergonomic hazards to the employee. The Committee was asked to identify the hazards associated with using nonhuman primates in research, assess the degree of risk of these hazards, and suggest options for managing the risks including engineering controls, personal protective equipment, facilities design, and worker training. The committee was also asked to make recommendations for institutional management of workers after suspected exposure to infectious agents. The Committee approached this task by focusing on major hazards and risks to workers at all nonhuman-primate research facilities. Recognizing that the level of risk associated with a hazard is dependent on numerous factors that vary from institution to institution, the Committee on Occupational Health and Safety in the Care and Use of Nonhuman Primates put forth in this report a programmatic structure for assessing and managing risk at different kinds of institutions. In addition to providing this structure and discussing the elements necessary for the successful implementation of an occupational health and safety program, the Committee reviewed specific recommendations on the use of personal protective equipment and the medical management of exposed workers. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report:

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Patrick Breysse, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland Thomas Butler, Southwest Foundation for Biomedical Research, San Antonio, Texas Roy Henrickson, Private Consultant, Point Richmond, California Nicholas Lerche, California National Primate Research Center, Davis, California Keith Mansfield, New England National Primate Research Center, Southborough, Massachusetts James Schmitt, National Institutes of Health, Bethesda, Maryland Ara Tahmassian, University of California San Francisco, San Francisco, California Stuart Zola, Yerkes National Primate Research Center, Atlanta, Georgia Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by W. Emmett Barkley, Howard Hughes Medical Institute, Chevy Chase, Maryland. Appointed by the National Research Council, he was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution. Since this report will undoubtedly be updated in the future, the members of the Committee ask that comments, corrections, and ideas for future studies be sent to the Institute for Laboratory Animal Research, The National Academies, 500 Fifth Street, NW, Washington, DC 20001. Frederick A. Murphy, Co-Chairman Jeffrey A. Roberts, Co-Chairman Committee on Occupational Health and Safety in the Care and Use of Nonhuman Primates

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Contents     EXECUTIVE SUMMARY   1 1   INTRODUCTION AND OVERVIEW   4     Occupational Health and Safety Program,   5     Overview,   6 2   BACKGROUND AND CONTEXT FOR OCCUPATIONAL HEALTH AND SAFETY IN THE CARE AND USE OF NONHUMAN PRIMATES   9     Introduction,   9     Intent of this Report,   10     Implementing the Occuptional Health and Safety Program,   11     Hazards Associated with Nonhuman-Primate Behavior,   14     Risks and Risk Reduction Associated with Environmental Enrichment,   19 3   IDENTIFYING INFECTIOUS HAZARDS ASSOCIATED WITH THE USE OF NONHUMAN PRIMATES IN RESEARCH   21     Viral Diseases,   23     Bacterial Diseases,   40     Protozoan Parasites,   47     Metazoan Parasites,   51     Other Agents,   55     Summary,   57

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4   IDENTIFYING NONINFECTIOUS HAZARDS   59     Physical Hazards,   60     Chemical Hazards,   65 5   RISK ASSESSMENT: EVALUATING RISKS TO HUMAN HEALTH AND SAFETY   68     Background,   68     The Process of Risk Assessment,   69     Risk of Occupational Injuries and Exposures at National Primate Research Centers,   80 6   OCCUPATIONAL HEALTH AND SAFETY REGULATIONS AND RECOMMENDATIONS APPLICABLE TO NONHUMAN-PRIMATE RESEARCH FACILITIES   83     Federal Occupational Health and Safety Requirements,   83     State Occupational Health and Safety Requirements,   89     Useful References,   90 7   RISK MANAGEMENT: THE PRINCIPLES UNDERLYING THE DESIGN AND IMPLEMENTATION OF AN OCCUPATIONAL HEALTH AND SAFETY PLAN   94     Administrative Procedures,   96     Facility Design and Operation,   97     Exposure-Control Methods,   98     Education and Training,   102     Occupational Health,   102     Tuberculosis Testing,   105     Equipment Performance,   105     Information Management,   107     Emergency Procedures,   107     Program Evaluation,   108 8   PERSONNEL QUALIFICATIONS, TRAINING, AND CONTINUING EDUCATION   120     Introduction,   120     Personnel Qualifications,   121     Training,   123     Continuing Education,   133     Recordkeeping,   134

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9   POSTEXPOSURE MEDICAL TREATMENT IN NONHUMAN-PRIMATE FACILITIES   135     Defining Exposure Risk,   136     Scope of Potential Infectious Agents in Nonhuman Primates,   136     Defining Routes of Exposure,   137     Determining Appropriate Postexposure Medical Management,   139     First Aid after Exposures to Nonhuman Primates,   140     Medical Evaluation and Followup,   141     B Virus Exposure,   144     Exposure to Simian Immunodeficiency Viruses,   145     Other Retroviruses,   146     Recombinant-Vaccinia Research,   146     REFERENCES   147     APPENDICES     A   WORKSHOP SPEAKERS   159 B   COMMITTEE MEMBER BIOGRAPHIES   161

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Occupational Health and Safety in the Care and Use of Nonhuman Primates

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