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, 2003 EXECUTIVE SUMMARY The Committee on Occupational Health and Safety in the Care and Use of Nonhuman Primates was appointed by the National Research Council (NRC) in response to requests from the National Institutes of Health, the Centers for Disease Control and Prevention, and the Food and Drug Administration to address the risks associated with occupational exposure to nonhuman primates and suggest practical and efficacious ways of minimizing these risks. Specifically, the committee was asked to: 1. Identify hazards associated with using nonhuman primates in research. 2. Assess the degree of risk of these hazards. 3. Suggest options for managing the risks including engineering controls, personal protective equipment, and worker training. 4. Outline the institutional management of workers after a suspected occupational exposure. 5. Provide sample illustrative occupational health and safety plans for personnel working in large and small nonhuman-primate facilities. The Committee on Occupational Health and Safety in the Care and Use of Nonhuman Primates drew from the experiences of a number of experts, including infectious disease clinicians, primate veterinarians, primate caregivers, and occupational health professionals during a workshop held at the outset of the project (See Appendix A for a list of participants). These experts agreed that the most effective way to identify and manage hazards associated with nonhuman primates is through the development and implementation of an institutionally specific occupational health and safety program (OHSP). This report discusses in detail the building blocks of a successful OHSP, namely identification of hazards, risk assessment, identification of applicable safety regulations, risk management, and personnel training. It also emphasizes the importance of a strong institutional commitment to an OHSP and the clear delegation of responsibility, authority, and accountability at all stages of development, implementation, evaluation, and re-evaluation of the OHSP. The National Research Council developed a document on occupational health and safety for animal research facilities (NRC 1997), which has served as a guide for the management of an OHSP and has provided a foundation for the development of an institutional OSHP where none exists. The present report attempts to aid in the development or improvement of OHSP at nonhuman-primate facilities or facilties that use nonhuman-primate blood or tissue and is not intended to duplicate the scope or content of the previous document. Rather, its goal is to complement that publication and expand on topics that are particularly relevant or specific to facilities where nonhuman-primate species are housed. This report has also attempted to address the meaning and implications of uncertainty in risk management. This report is intended as a reference for vivarium managers, veterinarians, researchers, safety professionals, and any other persons who are involved in developing or implementing an OHSP dealing with nonhuman primates. The diversity of institutions, research programs, and animal colonies makes it impossible to encompass all the details of a complete institutional OHSP in this report. Instead, it attempts to list the important features of an OHSP and provide the tools necessary for informed decision-making in developing an optimal program that meets all particular institutional needs. The Committee identified and assessed numerous risks, infectious and noninfectious, of working with nonhuman primates or their blood or tissues. Significant risks included ergonomic injuries and illnesses caused by shigella, tuberculosis, and B virus infections. These risks can be effectively dealt with using a layered approach to exposure control. Engineering controls are an essential mode of exposure/injury control and include facility design and specialized equipment such as biosafety cabinets. Work practices within the facility provide another modality in exposure/ injury control, but can be most important. Development of standard operating procedures that are universally followed and are integrated into employee training can effectively mitigate many hazards. Another important element in exposure/injury control is the use of personal protective equipment (PPE). PPE for use in nonhuman-primate facilities should minimally include dedicated clothing, gloves, and mask. The Committee stresses that PPE should only serve as a safety net if engineering and work practices should fail. But in light of the potentially fatal risks associated with B virus and other viral exposures, the appropriate use of PPE is a particularly important issue. The Committee concluded that because of the risk of B virus infection, the use of eye and face protection should be mandatory for individuals working with macaques. The Committee also recommended that eye and face protection be used when working with any Old World primate, due to the potential for infection by other primate viruses such as simian immunodeficiency virus. For other nonhuman-primate species, the Committee recommends that the use of eye and face protection be determined locally, based on risk assessment and management processes outlined in this report. Appropriate medical care after a suspected occupational exposure to a zoonotic pathogen is another area where specific guidance has been lacking in spite of various federal regulations and guidelines. The Committee determined that the first and often most critical step in developing an OHSP is the establishment of a relationship with a pre-designated occupational health care provider. Involving the designated medical providers in determining exposure risks before an incident occurs may lead to quicker and more effficacious post-exposure management. In this report, the Committee makes specific recommendations for medical management following exposure to or injury from nonhuman primates. The field of occupational health and safety constantly changes, especially as it pertains to biomedical research. The emergence of new hazards presents diverse challenges to employers who must ensure the safety of their employees. New infectious hazards are of particular importance at nonhuman-primate facilities. For example, the discovery that B virus can be transmitted via a splash on a mucous membrane raises new concerns that must be addressed, as does the discovery of the Reston strain of Ebola virus in import quarantine facilities in the United States. The risk of such infectious hazards is best managed through a flexible and comprehensive OHSP that can identify and mitigate potential hazards. It is incumbent on those responsible for nonhuman-primate research facilities, from the senior institutional officer to the facility manager to line supervisors, to develop, improve, and implement such a program. TABLE OF 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 Occupational 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 4. IDENTIFYING NONINFECTIOUS HAZARDS 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 FACILlTlES 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 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 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. Petes, 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 Grosshlatt, Editor Jennifer Obernier, Program Officer Susan Vaupel, Editor 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 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: 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 ISBN: 030908914X (paperback) $35.00 USD, online for $28.00 USD PDF ISBN: 0309524652 $21.50 USD PDF AND BOOK BUNDLE AVAILABLE FOR $34.00 USD WHERE TO ORDER: The National Academies Press 2101 Constitution Avenue, NW Lockbox 285 Washington, DC 20055 General Phone: 1-800-624-6242 Phone: (202) 334-3207 Fax: (202) 334-2793 Email: jhenig@nas.edu Website: www.nap.edu Posted Date: 7/9/2003
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