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1 Introduction, Overview, and Recommendations INTRODUCTION Much has been written about the obligation of institutions that care for and use research animals to be protective of the health and well-being of the animals. Thoughtful consideration of that institutional obligation has resulted in substan- tial improvements over the last 3 decades in animal-husbandry practices, facility design criteria, caging specifications, and institutional policies that govern the use of animals in research. But it has yielded little authoritative guidance for addressing a related institutional obligation the protection of the health and safety of employees who care for and use research animals. Fortunately, progress in enhancing the quality of animal-care programs has had a beneficial effect in minimizing occupational-health risks of institutional employees. This book by the Committee on Occupational Safety and Health in Research- Animal Facilities, in the Institute of Laboratory Animal Resources of the Na- tional Research Council's Commission on Life Sciences, is about the occupa- tional health and safety of institutional employees, visitors, and students who in the course of their work with research animals might be exposed to hazards that could adversely affect their health and safety. Our task is to promote occupational health and safety by recognizing and considering hazards and health risks associ- ated with the care and use of research animals. The book is written to be of assistance to institutions that are in the process of developing or re-evaluating occupational health and safety programs for employees engaged in animal care and use. The general concepts set forth apply to many categories of institutions: academic, industrial, and government research institutions; biomedical and agri 1

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2 OCCUPATIONALHEALTH AND SAFETY OFRESEARCH-ANIMALWORKERS cultural research institutions; and medical and veterinary educational institutions. The book should also be useful to persons responsible for overseeing the health and safety of employees in related occupations, such as those in general veteri- nary practices, zoologic institutions, animal shelters, and kennels; employees in these categories face many of the same risks that are associated with the care and use of research animals. Most research institutions have established environmental health and safety offices to foster institutional compliance with regulations promulgated by the Occupational Safety and Health Administration (OSHA) and the Environmental Protection Agency. Program emphasis has been placed on general awareness of hazardous chemicals, chemical safety in laboratories, control of bloodborne pathogens, and management of hazardous wastes. Collectively, this has been an overwhelming responsibility, with few resources available to develop the new program initiatives that are required to emphasize occupational health in animal care and use programs. At the same time, the perceived need to provide occupational-health ser- vices, such as preassignment physical examinations and medical surveillance, to employees engaged in animal care and use has been driven by institutions' inter- pretations of broad regulatory requirements or contractual obligations imposed by funding agencies. Confusion as to what is needed and what is required has slowed the development of relevant program activities. Some institutions have undertaken expensive efforts to provide a broad array of occupational-health services, many of which have little benefit for the employee. Others have created health and safety programs that have no occupational-health component. Artificial barriers to intra-institutional communication have often stifled the initiative of the persons in the institution who must become involved if worthy programs to promote occupational health and safety are to be developed. For example, the rigidity of jurisdictional boundaries has caused some managers of vivariums to avoid providing safety oversight and guidance to employees in other departments who conduct research in the vivariums. The institutional animal care and use committee (IACUC) is often the only forum for interaction, but its responsibilities are related only indirectly to occupational health and safety. Con- tinuing collaboration among scientists, safety experts, health-care professionals, veterinarians, and administrators to promote health and safety has been difficult to initiate and difficult to sustain. Other barriers to effective program develop- ment involve several commonly unresolved questions: Who is responsible? Who will provide the necessary resources? Who has the authority to act? We recognize that institutional management, particularly the direction and guidance provided by the senior official of an institution, is the key element required for developing and sustaining any useful occupational health and safety program. A truly successful program, however, will ultimately depend on the participation of all employees whose work might affect occupational health and safety their own, their colleagues', their subordinates', or their co-workers'.

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INTRODUCTION, OVERVIEW, AND RECOMMENDATIONS 3 Thus, protecting the health and safety of employees engaged in the care and use of research animals is a cooperative enterprise that requires the active participa- tion of institutional officials, scientists who plan and carry out research involving experimental animals, persons responsible for the management of animal care and use programs, health and safety professionals, and the individual employees themselves who must share the responsibility both for their own health and safety and for the health and safety of those around them. This volume is addressed to all who are responsible for the health and safety of employees engaged in the care and use of research animals. We have tried not to be prescriptive in writing this book, and we do not present an ideal model for an occupational health and safety program. Such an approach would destroy our very premise: that there are many valid ways to fulfill an institution's commitment to provide a healthful and safe environment for an animal care and use workforce. The best model is one that accurately reflects the risks inherent in the research activities conducted at a specific institu- tion and allows for the careful development and use of practical and relevant methods for controlling the hazards that contribute to those risks. The guidance provided here is intended to help individual institutions to address their own circumstances comprehensively and to determine their own best courses of ac- tion. This process demands good judgment and a genuine commitment to reduce risks to an acceptable level. It also requires objectivity because a careful consid- eration of local circumstances might result in the elimination of activities that were once but are no longer thought to be of value. We expect institutions to choose to address the health and safety needs of animal care and use employees within the context of their existing environmental health and safety programs. But new initiatives must be the product of interac- tions among employees who represent administration, research, animal care and use, and occupational health. If not all these activities are involved in the devel- opment of program initiatives, the program will lose relevance, general accep- tance, and effectiveness. This book is designed to serve as an introductory guide to hazards associated with the care and use of research animals. We have tried to be comprehensive in our treatment of hazards that are inherently associated with the use of animals, such as allergens, zoonoses, and the obvious physical hazards, e.g., biting. We have dealt only briefly with hazard-control practices that are fully treated else- where. Readers will be guided to other references that should be consulted for further information on safe practices appropriate to their own circumstances. OVERVIEW The bulk of this book is divided into six chapters: Chapter 2 deals with how an institution addresses its responsibility for involving all employees and pro- grams to meet the occupational health and safety concerns of all persons; Chapter

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4 OCCUPATIONALHEALTH AND SAFETY OFRESEARCH-ANIMALWORKERS 3 addresses physical, chemical, and protocol-related hazards associated with ani- mal research; Chapter 4 provides a comprehensive discussion of allergic hazards; Chapter 5 summarizes relevant information on zoonoses of common research animals; Chapter 6 provides a general discussion of the key elements that are likely to be included in effective institutional programs; and Chapter 7 introduces concepts that are important in the development of the occupational-health ele- ment of the program. A brief overview of these chapters follows. Chapter 2. Program Design and Management The material in this chapter lays the foundation for developing an occupa- tional health and safety program that addresses employee risks of illness and injury associated with the care and use of research animals. Program design requires an understanding of the tasks of at-risk employees; those employees' diversity in experience, education, and language proficiency; characteristics of the work environment; and the institutional mission. The work environment and mission are of paramount importance because they determine the nature of the hazards presented by the animal research activities. The chapter defines the basic concepts that determine the effectiveness of an occupational health and safety program, which include the following: Knowing the hazard. Avoiding and controlling exposures. Training and education. Rules and guidelines. Consistency. Recordkeeping and monitoring. Commitment and coordination. The importance of accountability and responsibility is stressed. Ultimate responsibility rests with the senior official of the institution. Program managers, supervisors, and employees all have key roles on which the success of the health and safety program depends. The chapter introduces the concept that an effectively operating program depends on interaction among distinct functional parts of an institution. Five general functions are defined, and the necessary interactions among them are described. The five are Animal care and use. Research. Environmental health and safety. Occupational health. Administration and management.

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INTRODUCTION, OVERVIEW, AND RECOMMENDATIONS s It is suggested that the IACUC can provide helpful links among the five institu- tional functions. The chapter concludes with a discussion of tasks that can aid an institution in designing an effective occupational health and safety program. The importance of hazard identification to the process is emphasized. This discussion is intended to be helpful both to institutions that have well-established health and safety programs and to institutions that are just beginning to face the task of reducing hazards to an acceptable point. For the former institutions, the discussion might help to reinforce the value of current health and safety activities and stimulate improved collaboration among programs that are supposed to protect employees. The latter institutions will find the information useful in creating a relevant health and safety program, which will require gaining an understanding of their current health and safety status, identifying existing hazards, estimating current health and safety risks and financial costs associated with them, and assessing compli- ance with regulations. Chapter 3. Physical, Chemical, and Protocol-Related Hazards Development of an occupational health and safety program depends on know- ing the hazards that are present in the animal care and use setting and understand- ing the relative importance of those hazards with respect to the risks of occupa- tional injury and illness. This chapter provides insight into the identification of physical, chemical, and protocol-related hazards. It describes hazards that are likely to be associated with animal care and use. The discussion on protocol-related hazards emphasizes the responsibility of investigators to identify hazards associated with their research and to select the safeguards that are necessary to protect employees involved in the care and use of their research animals. Guidelines of the National Research Council for planning experiments with hazardous chemicals are offered as a useful approach for incor- porating safety considerations into the design of protocols involving the experi- mental exposure of animals to toxic chemicals. Recommendations of the Centers for Disease Control and Prevention and the National Institutes of Health should be followed by investigators who are planning research activities that involve experimentally or naturally infected animals; these recommendations are briefly summarized in the text. Chapter 4. Allergens The prevalence of allergic reactions among animal-care workers suggests that allergenic hazards are ubiquitous in the setting of animal care and use. It is estimated that some 30% of persons with pre-existing allergic conditions, such as allergic rhinitis, might eventually develop allergy to animals. This chapter de- scribes the types and mechanisms of allergic reactions that follow specific expo

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6 OCCUPATIONALHEALTH AND SAFETY OFRESEARCH-ANIMALWORKERS sures to a variety of experimental animals. Suggestions for preventive measures and interventions are also introduced. Chapter 5. Zoonoses This chapter' s comprehensive treatment of zoonoses will be a valuable refer- ence for everyone interested in animal care and use. The likelihood of occupa- tionally acquired zoonoses is much lower than it is popularly perceived to be. Knowledge of the health status of research animals and improvements in veteri- nary care have helped to ensure the availability of healthy research-animal popu- lations. And exposures can be reduced even more by maintaining an awareness of zoonotic hazards and routinely carrying out appropriate hazard-control measures. The chapter presents material on zoonoses by agent category. It addresses most of the zoonotic diseases important to personnel working with laboratory animals and organizes the information according to this format: . Reservoir and incidence. Mode of transmission. Clinical signs, susceptibility, and resistance. Diagnosis and prevention. Chapter 6. Principal Elements of an Occupational Health and Safety Program This chapter reviews the key elements of the traditional occupational health and safety program that contribute to the control of hazards and reduction of risks. Those elements constitute the scope of program activities that need to be considered in maintaining an effective occupational health and safety program. They are identified as Administrative procedures. Facility design and operation. Exposure control. Education and training. Occupational health. Equipment performance. Information management. Emergency procedures. Program evaluation. The occupational-health element is treated in Chapter 7.

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INTRODUCTION, OVERVIEW, AND RECOMMENDATIONS Chapter 7. Occupational Health-Care Services 7 This chapter focuses on the occupational health-care services of an occupa- tional health and safety program. Health-care services that are appropriate for employees engaged in the care and use of research animals are reviewed. Con- trary to the prevailing view in many institutions, few regulatory mandates require institutions to provide specific health-care services to employees, and such re- quirements that do exist are usually limited to circumstances that present substan- tial risk to employees. For example, OSHA's bloodborne-pathogens standard requires an institution to make hepatitis B vaccination available to all employees who handle blood, organs, or other tissues from experimental animals that are infected with hepatitis-B virus (HBV). However, the Public Health Service re- quirement that institutions that receive federal funds for animal research provide an occupational-health program for employees with substantial animal contact has been broadly interpreted as a mandate to provide a comprehensive array of health-care services, including physical examinations and preplacement baseline serum collection and storage. This chapter emphasizes that an adequate risk assessment must be a prerequisite in selecting appropriate health-care services for employees at risk. The following factors should be considered in performing an adequate risk assessment: Animal contact. Exposure intensity. Exposure frequency. Physical and biological hazards presented by the animal. Hazardous properties of the agents used in the research protocols. Susceptibility of the employee. Occupational-health history of employees doing similar work. The health-care services that might be included in the occupational-health element are briefly described. We draw attention to considerations that are im- portant in selecting specific services. Our discussion, however, is not meant to imply that a particular service is appropriate for all circumstances. We emphasize here, as we do throughout this book, that activities and services that are most likely to protect the occupational health and safety of employees will be judi- ciously based on an assessment of factors that place employees at risk for occupa- tional injury or illness. RECOMMENDATIONS In writing this book, we considered several controversial issues, such as whether "substantial animal contact" was a valid indicator for determining the need for an occupational-health program. We also debated issues that were con

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8 OCCUPATIONALHEALTH AND SAFETY OFRESEARCH-ANIMALWORKERS sidered to lessen the effectiveness of well-intended occupational health and safety programs. The results of our deliberations are presented here in the form of specific recommendations. Addressing Occupational Health and Safety in Animal Care and Use Programs Many institutions that support and conduct animal research have an environ- mental health and safety staff that helps the institution to fulfill its responsibility to provide a safe and healthful workplace for employees. The occupational-health concerns pertaining to the care and use of research animals, however, have often not been comprehensively addressed by these institutions. In particular, the occu- pational-health element of an occupational health and safety program might lack focus, and its contributions to a successful program might not be well understood. We recommend that every institution initiate a concerted effort to address the health and safety hazards and the risks of occupational illness and injury that are associated with the care and use of research animals and broaden its occupa- tional health and safety program as necessary to reduce the risks to an acceptable level. The effort should involve the collaborative participation of people repre- senting all institutional activities related to the care and use of research animals, including not only the animal care and use program itself, but also research, environmental health and safety, occupational health, and management and ad- ministration. Those activities should interact continually to maintain a successful occupational health and safety program. Institutions should consider the value of the institutional animal care and use committee in fostering the objectives of developing collaboration and sustaining interaction. Institutional Commitment and Delegation of Authority This report emphasizes the importance of interactions among many compo- nents of an institution in developing and maintaining a successful occupational health and safety program. Few criteria of success are more important than unam- biguous identification of responsibility and delegated chains of authority. We recommend that the senior official of an institution demonstrate personal commitment to a safe and healthful workplace, delegate clearly defined duties to those with authority to commit and direct institutional resources, and establish mechanisms for monitoring the success of the occupational health and safety program. Risk Assessment: A Dynamic and Continuing Process The purpose of an occupational health and safety program is to minimize risks of occupational injury and illness by controlling or eliminating hazards in

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INTRODUCTION, OVERVIEW, AND RECOMMENDATIONS 9 the workplace. However, the need for a continuing process to review and address changes in the hazards and risks associated with new research programs, new technologies, emerging biological hazards, and the diversity of the workforce is often overlooked. We recommend that every institution develop a multidisciplinary approach to occupational health and safety that permits the continuing evaluation of poten- tial workplace hazards and of the risks to employees working with animals. The assessment of risk should not be limited to determination of frequency of contact, but should include the intensity of exposures, hazards associated with the animals being handled, the hazardous properties of agents used in research, the suscepti- bility of individual employees, the hazard-control measures available, and the occupational history of individual employees. Occupational health and safety programs should be dynamic and able to adapt to changing circumstances. Participation in the Occupational Health and Safety Program Many institutions limit participation in their occupational health and safety programs to full-time employees who are involved in the care and use of animals. That approach fails to acknowledge that employment status is not a relevant criterion in exposure. Students, visiting scientists, volunteers, and other nonemployees can be subjected to substantial risks associated with exposure even during brief or sporadic involvement in animal care and use. We recommend that an occupational health and safety program provide for the appropriate level of participation of all personnel involved in the care and use of research animals on the basis of the risks encountered, regardless of their employment status. Determining Need for Health-Care Services Substantial contact with research animals is not a sufficient indicator of the need for health-care services. The provision of health-care services might be necessary only for particular employee groups with specifically defined occupa- tional-health risks. We recommend that the determination of need for health-care services be based on the nature of the hazards associated with the care and use of research animals and the intensity and frequency of employee exposure to these hazards. Overall risk assessment is key to determining this need. Serum Collection and Physical Examinations Serum collection and storage and physical examinations have been regarded by many institutions as typical services of an occupational health and safety program and have been applied to employees who have substantial contact with

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10 OCCUPATIONALHEALTH AND SAFETY OFRESEARCH-ANIMALWORKERS research animals. Although those services might have value for some employee groups at substantial risk for occupational illness, they are neither helpful nor cost-effective strategies for protecting the health and safety of most employees who have contact with research animals. We do not recommend serum collection and storage as standard components of an occupational health and safety program. They have value only for employ- ees who have substantial likelihood of occupationally acquired infection with an agent that can be monitored serologically. We do not recommend a physical examination as the principal surveillance tool for periodic health evaluations. We recommend that a careful history based on a knowledge of workplace risks be used for this purpose. It is appropriate, however, to perform a physical examination when symptoms of work-related illness become evident during an episodic health evaluation.