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Occupational Health and Safety in the Care and Use of Research Animals (1997)

Chapter: PROGRAM DESIGN AND MANAGEMENT

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Suggested Citation:"PROGRAM DESIGN AND MANAGEMENT." National Research Council. 1997. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: The National Academies Press. doi: 10.17226/4988.
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Suggested Citation:"PROGRAM DESIGN AND MANAGEMENT." National Research Council. 1997. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: The National Academies Press. doi: 10.17226/4988.
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Suggested Citation:"PROGRAM DESIGN AND MANAGEMENT." National Research Council. 1997. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: The National Academies Press. doi: 10.17226/4988.
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Suggested Citation:"PROGRAM DESIGN AND MANAGEMENT." National Research Council. 1997. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: The National Academies Press. doi: 10.17226/4988.
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Suggested Citation:"PROGRAM DESIGN AND MANAGEMENT." National Research Council. 1997. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: The National Academies Press. doi: 10.17226/4988.
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Suggested Citation:"PROGRAM DESIGN AND MANAGEMENT." National Research Council. 1997. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: The National Academies Press. doi: 10.17226/4988.
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Suggested Citation:"PROGRAM DESIGN AND MANAGEMENT." National Research Council. 1997. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: The National Academies Press. doi: 10.17226/4988.
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Suggested Citation:"PROGRAM DESIGN AND MANAGEMENT." National Research Council. 1997. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: The National Academies Press. doi: 10.17226/4988.
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Suggested Citation:"PROGRAM DESIGN AND MANAGEMENT." National Research Council. 1997. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: The National Academies Press. doi: 10.17226/4988.
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Suggested Citation:"PROGRAM DESIGN AND MANAGEMENT." National Research Council. 1997. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: The National Academies Press. doi: 10.17226/4988.
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Suggested Citation:"PROGRAM DESIGN AND MANAGEMENT." National Research Council. 1997. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: The National Academies Press. doi: 10.17226/4988.
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Suggested Citation:"PROGRAM DESIGN AND MANAGEMENT." National Research Council. 1997. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: The National Academies Press. doi: 10.17226/4988.
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Suggested Citation:"PROGRAM DESIGN AND MANAGEMENT." National Research Council. 1997. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: The National Academies Press. doi: 10.17226/4988.
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Suggested Citation:"PROGRAM DESIGN AND MANAGEMENT." National Research Council. 1997. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: The National Academies Press. doi: 10.17226/4988.
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Suggested Citation:"PROGRAM DESIGN AND MANAGEMENT." National Research Council. 1997. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: The National Academies Press. doi: 10.17226/4988.
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Suggested Citation:"PROGRAM DESIGN AND MANAGEMENT." National Research Council. 1997. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: The National Academies Press. doi: 10.17226/4988.
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Suggested Citation:"PROGRAM DESIGN AND MANAGEMENT." National Research Council. 1997. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: The National Academies Press. doi: 10.17226/4988.
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Suggested Citation:"PROGRAM DESIGN AND MANAGEMENT." National Research Council. 1997. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: The National Academies Press. doi: 10.17226/4988.
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Suggested Citation:"PROGRAM DESIGN AND MANAGEMENT." National Research Council. 1997. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: The National Academies Press. doi: 10.17226/4988.
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Suggested Citation:"PROGRAM DESIGN AND MANAGEMENT." National Research Council. 1997. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: The National Academies Press. doi: 10.17226/4988.
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Suggested Citation:"PROGRAM DESIGN AND MANAGEMENT." National Research Council. 1997. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: The National Academies Press. doi: 10.17226/4988.
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PROGRAM DESIGN AND MANAGEMENT 11 2 Program Design and Management PROGRAM GOAL The goal of an occupational health and safety program is to prevent occupa- tional injury and illness. The program must be consistent with federal, state, and local regulations, but the principal focus of the program should be on the control of hazards and the reduction of risks, as opposed to merely satisfying regulations. This volume is intended to raise the awareness of investigators, personnel who care for and use animals, health and safety professionals, and administrators with respect to hazards associated with the care and use of research animals and to provide some reasonable and practical approaches to minimizing health and safety risks. The principles outlined in this chapter are aimed primarily at institutions that use research animals, but they apply equally well to nonresearch animal holding, breeding, and exhibiting. The strategies that promote health and safety in the care and use of research animals are similar to those applied generally in a research laboratory. The use of animals in research is an extension of other experimentation that occurs in the laboratory. Research animals and the procedures and techniques that attend their use, however, can present unique problems and challenges, many of which in- crease the hazards of experimentation. Those problems and challenges must be considered in the management of occupational health and safety programs. DIVERSITY A sound occupational health and safety program should recognize and re- flect the wide differences in job tasks in an institution and the diversity of the 11

12 OCCUPATIONAL HEALTH AND SAFETY OF RESEARCH-ANIMAL WORKERS personnel hired to perform those tasks. In many cases, it is difficult to identify all persons that interact directly or indirectly with animals. It is equally difficult to assign risk to each person and to determine each person’s level of participation in the occupational health and safety program. Investigators, clinicians, animal-care technicians, laboratory technicians, students, workers in areas adjacent to labora- tories, maintenance and custodial personnel, security personnel, and materials handlers may be included in the program. There is diversity in the health status of employees and risks associated with various work assignments performed by employees in particular job categories. Frequent turnover of employees in some job categories is inevitable and cannot be ignored in the design and implementa- tion of a program. An accurate job description is important in identifying poten- tial hazards. Relevant knowledge of the people involved will vary considerably. Educa- tion and experience should be considered when assessing the need for training. The amount of and approach to training cannot be based solely on a person’s educational level. For example, it is unwise to assume that someone with a graduate degree in a life science automatically requires less training in a particu- lar aspect of the animal care and use program than someone with no college background. An experienced farm worker, however knowledgeable about a given species, might not be informed adequately on issues related to the research pro- gram and the potential hazards associated with farm-animal species in a labora- tory setting. It is essential that a process be in place to assess the level of relevant training and experience of employees and to offer appropriate training at all levels. Employees who might not be involved directly with research activities should nevertheless be included in the occupational health and safety program. For example, maintenance and custodial personnel who will have only infrequent access to animal-care areas need to be informed of the potential hazards and precautions necessary for their protection. Similarly, animal-care personnel need to be made aware of potential hazards associated with research that uses the animals under their care. Additional training might be required along those lines. The demographics of the research community have changed. Language bar- riers and cultural differences must be considered and accommodated where there are people of different background and national origin, such as foreign students. The occupational health and safety program should also recognize and re- flect an understanding of the diversity of the work environment, including current facilities and potentially hazardous activities. This is a particularly important consideration during the design and construction of facilities and the renovation of existing ones. The type of research and the animal species used will influence the occupational health and safety program. For example, the use of pathogens, radioisotopes, and toxic chemicals calls for strategies different from those ap- plied to behavioral studies in which no hazardous research agents are handled.

PROGRAM DESIGN AND MANAGEMENT 13 The use of wild-caught animals can introduce more hazards than the use of laboratory-bred animals. BASIC CONCEPTS Many prudent practices to protect the health and safety of workers are al- ready widespread in institutions that care for and use animals. Such safe practices are sometimes based on common sense and sometimes on perceptions; some have been scientifically validated. An effort is made in this volume to identify practices that data have shown to be effective; when supporting data were not available, the committee suggested widely accepted practices commonly demon- strated as effective. Programs that are intended to protect employees vary considerably from institution to institution. That is partly because institutions’ needs depend on the scope of their programs. For example, containment needs for hazardous chemi- cals and extremely virulent microorganisms can be quite different. Institutions vary also in the sophistication of their overall health and safety programs. This volume provides guidance for all institutions in incorporating appropriate com- ponents related to animal care and use into their overall occupational health and safety program. An effective occupational health and safety program is based on seven basic concepts: • Knowing the hazards. • Avoiding and controlling exposures. • Training and education. • Rules and guidelines. • Consistency. • Recordkeeping and monitoring. • Commitment and coordination. Knowing the Hazards Determining the level of protection that is needed in any given situation depends on understanding the hazard in question. Defining and quantifying a hazard is sometimes referred to as risk assessment. The assessment, insofar as possible, should be based on scientific information. In the case of infectious agents, dose-response relationships, virulence, com- municability, prevalence, routes of exposure, shedding patterns, stability, and availability of prophylaxis and therapy are important considerations. For chemi- cal agents, one has to know about toxic doses, stability, form (liquid, gas, or solid), type of toxicity (irritation, corrosion, carcinogenicity, narcosis, lethality, etc.), severity of reaction, mode of action, and metabolic products. The main

14 OCCUPATIONAL HEALTH AND SAFETY OF RESEARCH-ANIMAL WORKERS sources of information for risk assessment are the scientific literature and profes- sionals and consultants with unpublished field experience. Those sources might fail to provide the necessary information, so additional research or increased caution is sometimes warranted. Experience has shown clearly that undetected hazards pose a major problem. Many undetected hazards are not related to the intended use of animals in a laboratory. For example, an animal might carry a human pathogen into a labora- tory. Unfortunate incidents have occurred when animals harboring zoonotic dis- eases, such as Q fever and lymphocytic choriomeningitis, have been used in research laboratories (Bowen and others 1975; CDC 1979; Hotchin and others 1974; Jahrling and Peters 1992; Spinelli and others 1981). Avoiding and Controlling Exposures It is common sense that it is better to avoid a hazard than to deal with the consequences of exposure to it. Measures related to this principle include train- ing, work practices, containment equipment, personal protective equipment, con- trol of access to hazardous areas, and use of purpose-bred animals. Safety mea- sures should be implemented in advance rather than after a problem emerges. Although reducing risk to employees is the primary goal of an occupational health and safety program, it should be recognized that it is impossible to elimi- nate risk. Training and Education Once a hazard is known, this knowledge must be communicated to animal care and use employees most directly involved and other employees (such as janitorial and maintenance workers) who might be at risk of exposure. Employee training begins with orientation immediately after hiring. Standard operating procedures should include methods for performing duties safely. New employees should be carefully instructed in those procedures by an experienced co-worker before assuming duties independently. Laboratory procedures can be reinforced with signs and posters. Periodic meetings to encourage safe work practices are advisable, and safety newsletters and electronic bulletin boards sometimes can be beneficial in keeping employees updated on changes. An institution has a crucial role in ensuring that its employees remain both well informed of relevant health and safety information and proficient in the use of safe practices. Rules and Guidelines Rules are necessary to ensure safety in the workplace. Rules governing the training of personnel, adherence to work procedures, use of disinfectants and decontaminants, access, waste disposal, use and maintenance of equipment and

PROGRAM DESIGN AND MANAGEMENT 15 safety devices, emergency procedures, reporting of accidents and exposures, and personnel behavior (smoking, eating, and hand-washing) should be rigidly en- forced. Rules are “musts,” whereas guidelines are recommendations and sugges- tions that allow for some judgment. For example, “No smoking, eating, or drink- ing in the animal room” would be a rule, whereas “The recommended use of chemical restraint before the use of hands-on procedures involving aggressive animals” would be a guideline. Consistency Consistency is essential to the success of an occupational health and safety program, including consistency in rules, enforcement, and application to all work- ers. Lack of consistency can undermine a program. For example, if employees are expected to wear masks and gowns to enter specified animal rooms, both super- visors and animal care and use staff should wear masks and gowns. When higher- level personnel ignore rules, it sets a bad example. However, too-rigid safety rules, at times considered unreasonable by employees, can undermine the cred- ibility of a program. Recordkeeping and Monitoring Developing and maintaining records is essential in an occupational health and safety program. It might start with a medical history of each employee to discover any facts that would bear on the general susceptibility of the employee to injury or illness. Reports of accidents, exposures, and work-related illnesses are absolutely necessary and sometimes required by law. Other forms of recordkeeping can provide useful information for monitoring safety programs and identifying deficiencies. Commitment and Coordination Commitment to safety must be a feature of an organization from top to bottom. Even the best safety program will fail if employees ignore the rules. The hierarchy of management must be committed if a safe attitude is to be instilled in workers. Animal facilities are rarely autonomous organizations; coordination is re- quired among administrators, research scientists, veterinarians, technicians, and maintenance workers. Every person’s role should be clearly defined because safety programs can fail if responsibilities are diffuse and not well understood. ACCOUNTABILITY AND RESPONSIBILITY Different parts of the overall occupational health and safety program are

16 OCCUPATIONAL HEALTH AND SAFETY OF RESEARCH-ANIMAL WORKERS necessarily managed by different people. The level of responsibility and account- ability for the design of the occupational health and safety program and for the program components should be well defined and can be divided into four levels: the institution, the program managers, the program implementors, and the indi- vidual employees. The Institution The institution, represented by its senior official (or an authorized body), has ultimate responsibility for providing a healthful and safe work environment and must have a commitment to that goal. The senior official must • Understand the issues. • Provide guidance. • Establish and support institutional policies. • Have authority to provide necessary resources. • Bring together program managers and implementors. Demonstrated actions of the senior official are essential to the success of the program. The senior official also makes assertions to regulatory agencies regard- ing compliance and must be confident that these assertions are valid and backed by appropriate documentation. The senior official is accountable for health and safety in the work place. This official must reasonably delegate or assign responsibility and authority for the program components to other appropriate persons. The official must have an adequate understanding of both technical and management issues and should be routinely advised in matters related to the program. Either a person, a task force, or a committee might be effective in addressing the complexities of designing and implementing a sound occupational health and safety program, but through- out the process the lines of authority must be clear, with all participants under- standing the communication and interaction needed to attain the objectives. A performance-based system or process, which focuses on the desired outcome of worker health and safety, can help an institution to address the many issues involved. Program Managers An effective occupational health and safety program depends on the involve- ment and commitment of program managers at all levels. Key managers will be those who have specific expertise in health and safety issues or who will be charged with and have the authority to implement and enforce components of the program. The program managers should include, if appropriate, the following:

PROGRAM DESIGN AND MANAGEMENT 17 • Health professionals. • Safety professionals. • Veterinarians. • Animal-facility managers or supervisors. • Research directors and scientists. • Laboratory supervisors. • Human-resource and finance personnel. • Legal advisers. • Environmental experts. • Facility engineers. It is imperative that research scientists, who direct experimentation, participate in the design, implementation, and management of the occupational health and safety program. Program Implementors Responsibility for implementation resides at the supervisory level. Training is a key function of an implementor’s responsibility. Training should emphasize the active and preventive nature of effective safety programs. Training programs should provide adequate information about the risks involved and preventive measures available. Implementation also involves providing appropriate equip- ment for personal protection, providing appropriate facilities, and ensuring com- pliance of subordinate staff with established procedures and practices. Employees For the purposes of a sound occupational health and safety program, an employee may be defined as any person who might be at risk from any activity within the institution that involves or is associated with the care and use of animals in research. All employees must share responsibility for their own health and safety and for the safety of those around them. All must work so as to protect themselves and others and incorporate safety into day-to-day activities. That requires that employees comply with rules, follow established standard proce- dures, report injuries, and be generally active in demonstrating safe work prac- tices. Employees at all levels should be involved in program design and improve- ment. Apart from regular employees, consideration should be given to the health and safety of students, part-time and temporary employees, full and part-time contractors, visitors, and volunteers.

18 OCCUPATIONAL HEALTH AND SAFETY OF RESEARCH-ANIMAL WORKERS INSTITUTIONAL ACTIVITIES AND THEIR INTERACTIONS An institution that uses animals in research is responsible for five main activities: • Animal care and use. • Research. • Environmental health and safety. • Occupational health. • Administration and management. Interactions among these activities are important for implementation and maintenance of an effective occupational health and safety program. The central focus of the health and safety issues discussed in this document is the care and use of animals in research, which includes the established animal care and use program and the institutional procedures for review and monitoring of animal use. It involves mainly a program manager, who is usually a veterinarian; the animal-care staff; and the institutional animal care and use committee. Research involving animal use is conducted by investigators and technicians in the research laboratories and in the animal facility. Scientists’ research objec- tives are directly supported by the animal care and use program. The environmental health and safety activity provides technical services that assist the institution in carrying out its responsibilities associated with health and safety; it involves people who have expertise in chemical safety, biological safety, physical safety, industrial hygiene, health physics and radiation safety, engineer- ing, environmental health, fire safety, and toxicology. Included in this activity are programs to collect, transport, and dispose of hazardous waste; manage responses to emergencies; monitor regulatory compliance; and provide training support and technical assistance. Occupational health involves primarily health-care profes- sionals, including physicians, occupational health nurses, and specialists required to assess potential health risks and manage the care of employees who have acquired an occupational injury or illness; it is often organizationally connected with the environmental health and safety activity. The administrative and management activities include involvement of the senior official and program managers and other human-resources, finance, risk- management, and property-management personnel. This section provides examples of these interactions among the five general activities. The discussion is intended to help an institution to identify potential interactions that will make it possible to carry out an effective occupational health and safety program (Figure 2-1).

PROGRAM DESIGN AND MANAGEMENT 19 FIGURE 2-1 Pattern of interactions. Animal Care and Use For purposes of this document, an occupational health and safety program is built around animals and their use. Most institutions have an institutional animal care and use committee (IACUC). By virtue of the IACUC’s responsibility for review and monitoring of animal use, it can help to provide links among many of the institutional functions related to health and safety.

20 OCCUPATIONAL HEALTH AND SAFETY OF RESEARCH-ANIMAL WORKERS Review of Proposed Animal Use A critical component of any program is the identification of potential haz- ards. Review of proposed animal use by the IACUC can appropriately include requests for information on the potential hazards involved in the proposed re- search protocols. That does not imply that the IACUC must conduct the review and assessment of potential hazards. But the committee is charged with ensuring or being assured that appropriate review is taking place. Hazard review can be accomplished by obtaining the advice or approval of other activities, committees, or responsible persons. For example, approval by the radiation-safety committee might be required before a study involving radionuclides is approved by the IACUC. Identification of potential hazards associated with research can also result in identification of concerns related to the husbandry of animals. Impacts of research on activities related to animal care, such as bedding disposal, are often overlooked. Additional training or hazard communication might be neces- sary for animal-care personnel in subjects not routinely encountered. The staff veterinarian should be closely involved in the planning and review of proposed animal uses. The IACUC and the veterinarian should specifically consider the potential for zoonotic disease and other potential hazards associated with the species involved. Consideration might involve the requirement for spe- cific training, preventive measures, or special health monitoring. Communication between the veterinarian and the investigator during the planning phase can ad- dress all those concerns before a proposal is presented to the IACUC for review and approval. In addition, changing circumstances associated with the introduc- tion of new research projects can be considered. The protocol-review process should provide an opportunity for identifying the personnel who will be involved in a research activity and therefore the per- sons potentially exposed to the associated hazards. It can stimulate close commu- nication with the investigator regarding the necessary training and experience of research staff. Involvement of the human-resources function during the hiring process can be helpful in identifying animal users. Monitoring of Animal Use Monitoring of animal use is a continuous process. Hazard awareness and attention to safety should be the responsibility of every employee; this responsi- bility includes following established rules and procedures, reporting injuries, identifying hazards, and demonstrating safe work practices at all times. Laboratory managers and supervisors must monitor compliance with estab- lished procedures and periodically review their appropriateness. Training of per- sonnel is an important part of this process. The IACUC is required to conduct periodic reviews of the animal care and use program and to inspect the animal facility and animal-use areas. It is appro-

PROGRAM DESIGN AND MANAGEMENT 21 priate during review and inspection to consider all the components of the occupa- tional health and safety program, including the research in progress. The facility inspection should include review of compliance with safe work practices and standard procedures, as well as the adequacy of the facility and equipment. The veterinarian and animal-care staff are in a unique position to monitor animal use continuously. Daily contact with the animals gives them a direct perspective of the use of the animals and, often, of the effectiveness of and compliance with health and safety procedures. Research The importance of involvement of research investigators and their staff in the design, management, and implementation of an effective health and safety program has been mentioned. Interaction with the veterinarian and the IACUC during project planning has become an expected and useful kind of communica- tion. Compliance with radiation standards and communication with the radiation- safety officer have long been practiced. Approvals for chemicals, infectious agents, or recombinant-DNA use might also be required. Many aspects of the health and safety program rely on active participation of workers in the research laboratories, not only in the animal facility. Environmental Health and Safety Responsibility for coordinating the occupational health and safety program often is delegated to the environmental health and safety staff. This staff should be responsible for, or involved in, the establishment of prudent practices that comply with Occupational Safety and Health Administration (OSHA) standards. The staff should participate with occupational-health professionals in the assess- ment of risk. Training and hazard communication should involve all appropriate employees. Information on zoonoses and specific animal-facility hazards should be provided, and this requires coordinated efforts among many activities listed in this section. The radiation-safety committee and the radiation-safety officer are respon- sible for establishing programs that ensure the proper use of ionizing and nonion- izing radiation. The use of radionuclides in an animal-research facility—subject to environmental health and safety review—involves a coordinated effort be- tween the radiation-safety committee, the research staff using the materials, and the animal-care staff. In most cases, the animal-care staff has little training in or understanding of radionuclide use and the associated hazards. Special training for animal-care staff, at a level of understanding necessary to provide safe routine husbandry, is required; it could be coordinated by the facility veterinarian (to identify persons involved in the care of the animals) and investigators (to deter- mine the nature of the hazard and the potential risk to animal-care personnel).

22 OCCUPATIONAL HEALTH AND SAFETY OF RESEARCH-ANIMAL WORKERS Waste management should also be under the purview of the environmental health and safety staff. In association with the return of animals to the animal facility and their maintenance after experimental exposure, procedures for hus- bandry, waste disposal, and monitoring should be well defined, communicated to all personnel, and followed. Monitoring the effectiveness of the occupational health and safety program depends on analysis of injury and accident data, which are generally managed by the environmental health and safety staff and the occupational health staff. Obvi- ously, compliance of individual employees with injury-reporting requirements is essential to this effort. Close interactions among these health and safety profes- sionals will make these retrospective studies more meaningful. Occupational Health Identification of new employees at risk and rapid evaluation for inclusion in the occupational health component of the occupational health and safety program is essential to ensure their protection. Close involvement of the occupational health staff with the human-resources and legal staffs of the institution is desir- able. Preplacement health evaluations and discussions with health professionals can provide an opportunity to establish a potential exposure profile and train and inform new employees of institutional policies and requirements. Occupational health physicians and nurses can be most effective if closely involved in or provided with a good understanding of the specific nature of potential and actual occupational exposures. The occupational health staff should be involved in the assessment of workplace hazards and risks; this activity is generally the responsibility of environmental health and safety staff but necessi- tates the participation of health professionals, the veterinary staff, and the scien- tists conducting the research. Close links to the animal care and research activi- ties are essential to an effective occupational health activity. Administration and Management Ultimately, the quality of an institutional occupational health and safety program depends on the support of management. Involvement of financial-man- agement personnel for budget planning and resource allocation is needed particu- larly when a comprehensive program is being implemented or equipment and facilities appropriate for the conduct of research are being provided. In addition, the periodic review of existing and desirable program elements by persons with control of institutional resources is helpful. The human-resources function can constitute an effective communication link to the research program through in- volvement in job classification, preparation of job descriptions, and information exchange during the hiring and orientation process.

PROGRAM DESIGN AND MANAGEMENT 23 MANAGEMENT STYLE AND STRUCTURE A most-important element in managing a successful occupational health and safety program is a favorable attitude toward promoting safe working conditions. There are several ways to generate and encourage such an attitude. The foremost is to involve representatives of all activities in the task of developing the occupa- tional health and safety program. The concept of safety must be presented in a cooperative spirit. The idea is to assist in reaching the institution’s goals without sacrificing safety. Safe methods should be developed in a helpful manner and not with the threat that something will be done in some specific way or not at all. Within the organizational hierarchy, another management style that fosters cooperation is leading by example. The converse of that is particularly damaging to a safety program; that is, if the supervisors ignore basic safety rules, they cannot expect their employees to behave differently. Rewarding employee compliance and admonishing those who break the rules is essential in communicating the importance of safety. Safety awards provide individual recognition and reinforce employee dedication. An employee who is apathetic or indifferent about safety should be counseled that such behavior jeopardizes everyone and will not be tolerated. There is no prescription for structuring an institutional occupational health and safety program. The size and complexity of a given institution influence the overall structure of its program. Some institutions centralize their occupational health and safety program; in others, the programs are more diffuse. In either case, it is important that all the elements of the program be covered and that responsibilities be clearly assigned. GETTING STARTED Each institution has its own organizational history and culture. The task of designing an occupational health and safety program for employees involved in the care and use of research animals will benefit from having an “institutional champion” to orient and guide the task group through the institutional maze; it is essential for defining the organizational boundaries of the five activities de- scribed earlier and learning helpful strategies for establishing necessary interac- tions among them. The availability and effectiveness of all elements of a program will depend on one absolute consideration: the senior official of the institution must be genu- inely and openly committed to maintaining an occupational health and safety program. A sincere commitment will ensure the availability of the support and resources necessary to enable the program to be operated effectively. Trying to develop an occupational health and safety program without the support of institu- tional leadership is a losing proposition. Only the institutional leadership can

24 OCCUPATIONAL HEALTH AND SAFETY OF RESEARCH-ANIMAL WORKERS identify the appropriate chains or networks of communication and authority within the institution. Priority List Many programs stumble by trying to initiate too many program components at once. It is useful to establish a priority list based on existing hazards and the current occupational health and safety status of the institution. Institutions typically choose to address the exposures that are causing the greatest current costs. Costs can be measured objectively, such as payments for worker compensation, or measured subjectively, such as unwanted mass-media attention, regulatory citations, or worker alarm over perceived hazards (indepen- dent of measurable risk). In the absence of an occupational health and safety program, relatively small and otherwise manageable problems can cause great institutional disruption. Once acute problems have been addressed, a priority list can be compiled on the basis of assessment of the magnitude and severity of identified risks. An institution might choose first to address the most-common or most-severe risks, or a combination of both, and then to identify exposures that, over time, would result in an unacceptable cumulative risk. Preparing for accreditation visits or OSHA inspections can focus institutional attention on issues of particular interest to such agencies. There is a hierarchy of control and prevention strategies. Primary prevention of occupationally acquired injury or illness is achieved by controlling or eliminat- ing hazards, and the quality and effectiveness of an institution’s occupational health and safety program will depend on how well resources are distributed to provide for and promote hazard-control strategies. Secondary prevention (premorbid case detection) and tertiary prevention (case-finding and disease man- agement) are less desirable as means of controlling occupational health and safety risks. Hazard Identification Identification of hazards is a challenge in all workplaces; animal care and research facilities are no exception. No databank, book, or journal will defini- tively identify all the hazards in the workplace. Identification of hazards is a responsibility of everyone: supervisors, managers, investigators, and other em- ployees. Many hazards are readily apparent. For example, lifting heavy animal cages and then twisting to put them onto a conveyor belt as it enters the cage- washing unit obviously constitutes a hazard. Others might require special knowl- edge to identify, such as ultraviolet light sources in an area where chlorinated solvents are used (the resulting phosgene production presents a hazard). Some hazards, like allergens, are ubiquitous but complicated by individual susceptibili-

PROGRAM DESIGN AND MANAGEMENT 25 ties and nonoccupational exposures. The challenges are to identify as many haz- ards as possible and to keep an open mind to new ones. An efficient way to identify hazards is to have an environmental health and safety professional who is trained in the recognition, measurement, and control of workplace hazards perform a walk-through review of the animal facility and the laboratories of investigators who conduct animal research. The quality of the review would be enhanced by the participation of a knowledgeable person from both the animal-care program and the research program. The review should be conducted when animal care and use are in progress. The reviewer should be attentive to the worker, the environment, the protocols, and the equipment. Op- erations that are being performed and how the employees are performing them should be carefully observed. Obvious signs of exposure—such as the presence of dust, nasal or eye irritation, chemical odors, and the accumulation of chemicals on work surfaces—should be noted. Observations should be compared to the expected performance of a well-trained worker operating properly designed equipment in a clean and safe work environment. The reviewer should under- stand the operations well enough to construct scenarios that might result in per- sonal injury. The purpose of the review should be discussed openly with the workers, and their observations and viewpoints should be sought. Workers are an indispensable source of information concerning the hazards that are associated with their work and should be encouraged to report hazards observed in the workplace either to their supervisor or to the environmental health and safety office. Many institutional data sources contain hazard information, e.g., accident reports, reviews of experimental protocols submitted by investigators, manufac- turers’ safety bulletins, safety reports prepared by labor unions, safety-committee reports, job-safety analyses, safety-audit reports, health and safety consultants’ reports, Material-Safety Data Sheets (MSDSs), and chemical inventories. Not all those sources are available in all workplaces. The sources that do exist should be consulted because they can provide unique site-specific information. The experience of other institutions can be helpful in identifying hazards. The Institute of Laboratory Animal Resources is an invaluable repository of relevant information and institutional contacts. Professional associations and so- cieties are among the best sources of information on animal-related health and safety issues. Those and other professional organizations hold conferences at which health and safety issues are discussed. Much of the value of such meetings results from the focused nature of the presentations and their application to spe- cific operations. Professional societies are excellent sites for developing net- works of experts in health and safety programs. Government agencies also have knowledgeable personnel who can be of great assistance. The relevant agencies include the National Institute for Occupa- tional Safety and Health (NIOSH), the Occupational Safety and Health Adminis- tration (OSHA), the Centers for Disease Control and Prevention (CDC), the

26 OCCUPATIONAL HEALTH AND SAFETY OF RESEARCH-ANIMAL WORKERS National Institutes of Health (NIH), the National Animal Disease Center (NADC), the Agricultural Research Service (ARS), and the Animal and Plant Health In- spection Service (APHIS). Given that a hazard is present in the workplace, the next question is, “How important is this hazard?” In answering this question, consideration needs to be given to the number of people who are exposed to the hazard, the potential effect of the hazard on the people, and the magnitude of the exposure. Exposure to a carcinogen from a skin-painting experiment would be considered a more-serious hazard than exposure to ammonia gas emanating from bedding materials. For the ranking process to be effective, however, it must take into account the frequency or probability of some consequence. For example, an exposed electric circuit on a cage-washing machine presents a hazard of electric shock. If, however, the unit is in a locked room and not used, the risk of an electric accident is very low. If the unit is the primary cage-washing machine and is used daily, the chance of an electric shock is much greater. In that simple example, the consequence (the electric shock) and the hazard (exposed electric contacts) are the same in both scenarios, but the likelihood of the consequence is different. Risk is a measure of the likelihood of a consequence, whereas hazard is the inherent danger in a material or system. Ranking of hazards on the basis of the characteristics of the consequence and the likelihood of the consequence enables an institution to understand the occupational health and safety risks in its animal-care and re- search programs and to plan appropriate risk-reduction strategies. The principal objective of an occupational health and safety program is to reduce to an accept- able level the risk associated with using materials or systems that might have inherent danger. That is accomplished by controlling or eliminating hazards. The actual injury and illness experience within an institution among employ- ees who are involved in the care and use of research animals is a key indicator of the presence of workplace hazards and can be used to estimate occupational risk and help to rank the importance of existing hazards. For example, animal bites and kicks are common but rarely life-threatening; back injuries are common and tend to be of greater severity and to lead to greater overall costs; laboratory- animal allergy is common and has a wide range of severity, from mild rhinitis through chronic asthma to life-threatening asthma or anaphylaxis; dermatitis is less common and rarely severe but can reduce barriers to other hazards like infectious agents; and B-virus infection is uncommon but life-threatening. Information about current occupational health and safety status in a particu- lar institution can be gathered from several key sources in that institution, as shown in Table 2-1. • Worker compensation. Worker compensation is the insurance system maintained by an institution to cover the medical costs and replace lost wages of workers with work-related illness or injury. The worker-compensation carrier typically can provide summaries of costs and lost days by medical diagnosis.

TABLE 2-1 Sources of Information About Worker Health and Safety Information source Who has information Relevant institutional data Reference data Worker-compensation • First Report of Injury or Illness Administration and management Number of reports Institutional trends • Insurance companies Institution’s insurance carrier Claims experience: Industry and company special reports, direct medical care costs institutional trends, compensation and lost-time costs agency reports, Federal Bureau of Labor Statistics Supplementary Data PROGRAM DESIGN AND MANAGEMENT System (SDS) OSHA 200 log Environmental health and safety Number of entries Institutional trends, OSHA “OSHA recordables” office, administration, and “compliance database,” National management (human resources) Safety Council “Accident Book,” Bureau of Labor Statistics annual summary of injury and illness First-aid log Institution Number of entries Institutional trends Occupational health log Occupational health office Periodic visits Institutional trends (participation rates), episodic visits Adverse-reaction reports Environmental health and Number of reports Institutional trends safety office 27

28 OCCUPATIONAL HEALTH AND SAFETY OF RESEARCH-ANIMAL WORKERS Costs and lost days per case can also be summarized to provide an index of the severity of an illness or injury. This information is extremely helpful in identify- ing hazards that cause the greatest adverse health effects in workers. Most insti- tutions choose to address those hazards quickly by putting into place adequate control strategies to avoid future compensation costs. The Federal Bureau of Labor Statistics receives data from 35 states that categorize and report injuries and illnesses that qualify for worker compensation. The resulting database is called the Supplementary Data System (SDS) and is available for public use. It can be searched to identify injuries and illnesses that have occurred at similar institutions and to discover the injury and illness experience of a specific group of workers. For example, the most recent publicly available data were obtained for the year 1986 on all injuries and illnesses that qualified for worker-compensation payments in California for the standard industrial classification code (SIC) 0740 (veterinary services). The data were analyzed to determine which kinds of work- ers were most likely to be injured and which types of injuries were most common. A total of 74 compensable injuries and illnesses were reported in this SIC. Of the 34 injuries that occurred among workers classified as “animal caretakers,” 54% were due to cuts, punctures, and bites by animals and 30% to overexertion due to lifting (SDS 1994). Information of that type is helpful in developing an under- standing of workplace hazards and in grouping workers on the basis of risk. Because worker-compensation insurance carriers are paid by employers, they can also provide historical data on an institution’s operations and analyses of trends to help reduce injuries. • First Report of Injury or Illness. These reports are used to inform the worker-compensation insurance carriers of the occurrence of a probable occupa- tional injury or illness. A report generally describes the injury or illness and identifies causative factors that might be immediately apparent. Reports can be acceptable alternative records to the Supplementary Record of Occupational In- jury or Illness (OSHA Form 101) that employers are required to maintain (BLS 1986). • OSHA 200 log. Most institutions are required by law to maintain a log of work-related illness and injury, commonly known as an OSHA 200 log (US Dept. of Labor). Injuries are defined as incidents that are instantaneous, such as a bite, kick, or needlestick. Illnesses are defined as conditions arising from noninstantaneous events, such as carpal-tunnel syndrome, animal allergies, and dermatitis. An injury is recordable if it results in the death of an employee, loss of consciousness, lost work time, placement on restricted duty, or treatment other than first aid. All recognized occupational illnesses are recordable. Lost time need not be incurred for an event to be recordable. The log does not provide a comprehensive summary of all work-related events in that minor injuries might not meet any criteria for being recordable. The same single entry is required for a minor or severe illness and for a recordable injury; hence, the log does not show the intensity or cost of an individual illness or diagnosis. However, a Supplemen-

PROGRAM DESIGN AND MANAGEMENT 29 tary Record of Occupational Injury or Illness (OSHA Form 101) must be pre- pared and kept by employers for each OSHA 200 log entry; this record contains detailed information concerning the injury or illness in question and can be helpful in investigating their sources. • First-aid log. First-aid logs are generally maintained by supervisors at the worksite. They are a useful source of information about minor occupational illnesses and injuries that are treated outside the occupational health unit; for example, workers with eye injuries are usually sent directly to an ophthalmolo- gist or emergency service, and the health unit might be unaware of their occur- rence. They are also a source of information about nonrecordable minor injuries. • Occupational health log. Institutions that have health units or provide other health services to employees will have available other information useful in assessing occupational risks of employees. Periodic and episodic visits to these clinics are the source of this information. Periodic visits are routine, scheduled visits for preventive care (e.g., immunizations or surveillance evaluations). The number of periodic visits at an employee health unit is determined by the number of workers who are eligible to participate in a medical-surveillance program, the magnitude of risks, and the rate of participation in established surveillance pro- grams. Surveillance visits can yield information on the prevalence of a condition in the worker population (e.g., the number of workers with animal-related al- lergy) and on the frequency of specific risks (e.g., a practitioner can ask a worker to estimate the number of times that he or she has been bitten in the preceding year). Episodic visits are nonroutine, unscheduled visits that are needed because of the occurrence of known or suspected work-related illness or injury. Episodic visits reflect the occurrence of cases of sufficient severity to require health ser- vices. • Adverse-reaction reports. Adverse-reaction reports identify symptoms or occurrences at the worksite that suggest increased risk from a hazard. They are typically kept by the environmental health and safety office but reviewed by the occupational health unit to determine whether a medical evaluation is needed. Each worksite determines the threshold for reporting an adverse reaction. Acci- dent reports are included in this category. Another source of information on hazards in the workplace is the record of citations issued for violations of OSHA regulations. It is useful to know what worksite conditions are commonly monitored by OSHA and what has been the basis for citations at other institutions. Institutions with established occupational health and safety programs are a good source of clarification. Information on hazards cited by OSHA is collected by OSHA and maintained in the Compliance Database, which contains information on all the hazards and company data ob- served by OSHA during inspections for which a citation was issued. Although it is limited to compliance data, it is useful because it provides a nationwide view of the safety-compliance issues in similar operations. Data are available on the

30 OCCUPATIONAL HEALTH AND SAFETY OF RESEARCH-ANIMAL WORKERS organization, the type of citation, and the number of workers exposed. To obtain information in the Compliance Database, request it from one of the OSHA re- gional offices. Work Plan As an occupational health and safety program is developed, periodic meet- ings of representatives of animal care and use, research, environmental health and safety, occupational health, and administration and management who will be- come involved in proper implementation are important. The meetings will pro- mote the necessary coordination of activities. It is easier to establish or expand an occupational health and safety program if diverse program elements are repre- sented in one room as the broad outlines of the work plan are developed. The frequency of the meetings will depend on the magnitude and complexity of the task. Measures of program effectiveness should be established and agreed on by the group. Measures of program effectiveness could include reductions in chemi- cal-exposure levels, specific injuries or illnesses, damaged-material costs, loss of work because of damaged equipment, and program costs per covered employee. If the program has clear goals, measuring its effectiveness can be straightforward. Plan for Resource Development Diverse resources are needed for the successful implementation of an occu- pational health and safety program. Administration and management often need to be sold on the value of the program; this is sometimes a challenge because it is difficult to measure avoided costs. A workforce that is aware of workplace hazards and proficient in practices for their control is perhaps the greatest resource that an institution can develop. It is appropriate to seek resources to train workers in the recognition and avoidance of hazards and the conduct of safe work practices. Resources should also be sought to correct workplace conditions that require workers to engage in repeated or cumbersome protection practices for safety. Hardly any problem encountered in laboratory-animal research is new. Time and money can be saved by seeking the advice of those who have dealt with similar problems and found suitable solutions. Formal or informal consultation can provide experience and perspective on issues for which programs must be developed in a setting of uncertainty. One of the primary functions of a consultant is to inform an institution of occupational health and safety facts that provide clear direction for program development and advise of gaps in occupational health and safety facts that must be filled by considered judgment. The work of an occupational health and safety program is accomplished by people with a detailed knowledge of the particular workplace, its research activi-

PROGRAM DESIGN AND MANAGEMENT 31 ties, and the institutional history of success and failure with control strategies. It is difficult for consultants to acquire and maintain this knowledge base. An occupational health and safety program is such a multifaceted enterprise that it is unlikely that a few persons will have all the expertise required. Special- ists might have to be added to the environmental health and safety staff. In institutions that lack an occupational health staff, necessary service can be ob- tained by contract. Such services can be in a medical center or a free-standing clinic or can be contracted to be established on the premises. It is essential that administrative oversight and responsibility be assigned to someone within the institution. Continuity of records and continuity of services are especially impor- tant if contract services are used. Plan for Evaluation and Update As a program develops, there can be an apparent increase in the frequency of occupational health and safety problems as case-finding increases. That is often unsettling for the administration and can mistakenly be taken as a sign of pro- gram failure. More commonly, it is a sign of a successful program, and costs of the occupational health and safety program decrease as the severity of conditions found decreases because of prevention and early diagnosis.

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Occupational Health and Safety in the Care and Use of Research Animals Get This Book
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Much has been written about the care of research animals. Yet little guidance has appeared on protecting the health and safety of the people who care for or use these animals.

This book, an implementation handbook and companion to Guide For the Care and Use of Laboratory Animals, identifies principles for building a program and discusses the accountability of institutional leaders, managers, and employees for a program's success. It provides a detailed description of risks—physical and chemical hazards, allergens and zoonoses, and hazards from experiments—which will serve as a continuing reference for the laboratory.

The book offers specific recommendations for controlling risk through administrative procedures, facility design, engineering controls, and periodic evaluations. The volume focuses on the worker, with detailed discussions of work practices, the use of personal protective gear, and the development of an emergency response plan.

This handbook will be invaluable to administrators, researchers, and employees in any animal research facility. It will also be of interest to personnel in zoos, animal shelters, and veterinary facilities.

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