AAALAC International publishes “Position Statements” that are used as supplemental requirements and recommendations in dealing with certain issues, such as adequate veterinary care, standards for the use of farm animals, and occupational health and safety. Position Statements are developed by Council to provide in-depth guidance on AAALAC’s expectations regarding these aspects of an animal care and use program. Position Statements provide enduring direction for the Council and the accreditation community on key aspects of animal care and use.
Science and education involving the use of animals is guided by the principles of the 3Rs, originally described by Russell and Burch in 1959 as Replacement, Reduction and Refinement. AAALAC International expects accredited institutions to apply these principles in a manner compatible with scientific and/or teaching goals.
Replacement of animals (absolute replacement) must be considered where non-animal models exist that are accepted by the scientific and, where applicable, regulatory communities. Examples may include, but are not limited to, validated, reliable and fit for purpose cell culture systems (including microphysiological systems), environmental health monitoring, computer modeling, simulation systems and other in vitro tests. However, consideration must also be given to relative replacement or use of animals with a lower potential for the perception of pain and distress.
When animal use is necessary in science or education, reduction techniques must be considered to support research rigor and reproducibility while minimizing the number of animals necessary to answer the scientific question. Examples may include, but are not limited to, fit-for-purpose experimental design, sound statistical and analysis practices, tissue sharing, responsible animal breeding, and, in well-justified cases, re-use of animals.
In addition to reduction techniques, refinement must also be considered to minimize pain and distress and provide positive experiences to enhance animal welfare throughout the animals’ lifetime. Examples may include, but are not limited to, social housing, biologically relevant enrichment, acclimation, habituation, positive reinforcement training and other welfare improvements to experimental procedures, housing, and handling. As refinements evolve, personnel should have access to current refinement training and educational opportunities.
Institutions should establish a strategy for implementing the 3Rs, considering these guiding principles while complying with all national or regional 3Rs regulations, policies, and guidelines. This strategy may serve as a tool for continuous improvement and can include a combination of practices such as protocol considerations, standard operating procedures (SOPs), elements of veterinary care, and other components of the animal care and use program, including fostering a strong culture of care.
The Institutional Official, the Attending Veterinarian, and the Institutional Animal Care and Use Committee or comparable Oversight Body (IACUC/OB) should promote and advise on the principles of the 3Rs including the protocol review process. All research groups and IACUC/OB members should receive regular training in the concepts of the 3Rs.
A Culture of Care may be defined as both a mindset and a holistic approach to caring for and working with research animals within an institution. It is exemplified by an organizational culture that starts with the commitment to go beyond compliance with minimum standards of local, regional or national regulatory requirements. A Culture of Care is demonstrated by promoting caring and respectful behavior towards animals and personnel, as well as instilling a sense of responsibility for sustaining processes of improvement. When implemented, a Culture of Care will ensure ongoing programmatic improvements. As such, the concept of Culture of Care is consistent with AAALAC’s mission to continuously improve animal welfare in science and education.
Culture of Care is not a recent concept. The Guide for the Care and Use of Laboratory Animals (NRC; 2011) states that “the implementation of a humane care program, and creation of a laboratory environment in which humane care and respect for animals are valued and encouraged, underlies the core requirements of the Guide and the system of self-regulation it supports”. Moreover, processes such as post-approval monitoring “should support a Culture of Care focusing on the animals’ well-being”.
The key components of Culture of Care include thoughtful consideration and active implementation of beneficial animal welfare and 3Rs practices for all species being maintained and worked with; promoting well-being of those caring for and working with research animals, an institutional emphasis on excellence in research integrity, quality and reproducibility, and the presence of mechanisms that foster institutional transparency and societal openness.
Animal care and use programs are encouraged to promote a Culture of Care. The Council on Accreditation may recognize evidence of an effective Culture of Care through commendations. Examples of Culture of Care may include:
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The animal care and use program is the collaborative responsibility of the Institutional Official, the Attending Veterinarian, and the IACUC or comparable Oversight Body (OB). The Attending Veterinarian or other equivalent veterinary position, hereafter abbreviated as AV, is responsible for the welfare and clinical care of animals used in research, testing, teaching, and production.
For the purposes of this Position Statement, the term “AV and/or designee(s)” is used below to recognize that responsibilities are often carried out by a team of individuals, and not solely the AV; however, AAALAC considers the AV to be the individual with primary oversight and authority.
This responsibility extends to monitoring and promoting animal welfare during all phases of the animal's life. It is expected that the program of veterinary care will uphold high standards of care and ethics. Moreover, the AV must have sufficient authority to treat an animal and institute appropriate measures to relieve pain or distress, including euthanasia. In fulfilling these duties in a research environment, the AV should interact collaboratively with the research team (e.g., the Principal Investigator or Study Director) when making critical decisions regarding animal health and welfare. The AV must have adequate resources to manage the overall program of veterinary care. AAALAC acknowledges that other qualified individuals may assume some of the roles and responsibilities of the AV, under the oversight of the AV. The AV may delegate responsibilities to other individuals, including other veterinarians, who are qualified to perform those duties.
Important aspects of the role of the veterinarian(s) and the program of veterinary care typically include the following:
In addition, the AV or designee(s) has further responsibilities related to their role in the program and on the IACUC/OB. For example:
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AAALAC International expects accredited institutions to comply with all national or regional regulations, policies and guidelines, as well as conditions of funding. Additionally, AAALAC International considers performance standards paramount when evaluating the space made available in cages or pens for housing animals used for research, testing or teaching. The performance criteria described in the ILAR Guide, Ag Guide, and ETS 123 are used by AAALAC in assessing the adequacy of cage or pen space available to the animal(s). In those countries where regulations or guidelines do not exist or mandate cage or pen dimensions, AAALAC International suggests institutions consider the ILAR Guide's space recommendations as a basis for addressing space needs while always recognizing that performance standards also must be met.
The Guide states that single housing of social species should be the exception. Social housing will be considered by AAALAC International as the default method of housing unless otherwise justified based on social incompatibility resulting from inappropriate behavior, veterinary concerns regarding animal well-being, or scientific necessity approved by the IACUC (or comparable oversight body). When necessary, single housing of social animals should be limited to the minimum period necessary and, where possible, visual, auditory, olfactory and, depending on the species, protected tactile contact with compatible conspecifics should be provided. In the absence of other animals, additional enrichment should be offered, such as safe and positive interaction with the animal care staff, as appropriate to the species of concern; periodic release into larger enclosures; supplemental enrichment items; and/or the addition of a companion animal in the room or housing area. The institution's policy and exceptions for single housing should be reviewed on a regular basis and approved by the IACUC (or comparable oversight body) and/or veterinarian.
AAALAC International recognizes that the biomedical or agricultural research, testing or teaching objectives as well as the health and welfare of the animals will dictate when application of the recommendations of the Ag Guide, ILAR Guide, or ETS 123 is most appropriate. For animals in an agricultural setting, AAALAC International takes the position that, in accredited programs, the housing and care for farm animals should meet the standards that prevail on a high-quality, well-managed farm. The collective professional judgment of the responsible oversight body (i.e., IACUC, Ethics Committee), principal investigator and veterinarian should determine which standard(s) applies best with regard to the care and welfare of agricultural animals, based on a performance approach in the context of the requirements of the study and the species used.* The rationale for making this determination should be documented.
*For institutions that also hold a U.S. Public Health Service Assurance, see additional information regarding this topic at http://grants.nih.gov/grants/olaw/faqs.htm#g7.
The safety of walk-in type cage/rack washers and bulk sterilizers must be addressed by the institution. AAALAC International has identified three key factors that must be considered when developing the safety plan for this equipment: 1) ease of egress, 2) a de-energizing* mechanism, and 3) personnel training. The possibility of entrapment must be eliminated, and in the case of cage/rack washers, ideally an emergency shut-off mechanism that is easily accessible from anywhere inside the machine and which de-energizes the washer when activated should be in place. Equipment operators must receive appropriate training so as to minimize their risk and proper instructional signage should be posted. Following risk assessment, other mechanisms and/or procedures, individually or in combination, might be determined to provide the same level of protection and eliminate possible entrapment, such as:
The design of bulk sterilizers precludes the inclusion of an explosion relief door latch or interior emergency mechanism, but other procedures such as the buddy system and/or lock-out system must be considered.
The adequacy of cage/rack washer and bulk sterilizer safety is the responsibility of the institution, typically through cooperative efforts among the animal facility personnel, occupational health and safety personnel, physical plant/facility maintenance personnel, and the IACUC (or comparable oversight body). The institution must provide the Council on Accreditation with sufficient evidence to demonstrate that issues regarding cage/rack washer safety have been addressed and will be periodically reviewed.
*The term “de-energize” indicates immediate flow stoppage of water into the interior of the cage washer, along with termination of the wash cycle such that restart requires deliberate reactivation of the machine. In the case of bulk sterilizers, this would involve immediate termination of the sterilization cycle, allowing immediate opening of the door/hatch and release of the person trapped therein.
An occupational health and safety program must be part of the overall animal care and use program. The basic elements of a program include hazard identification and risk assessment, personnel training and protection, written procedures and policies regarding hazard use and monitoring, and medical evaluation and preventive medicine.
The extent and level of participation of personnel in the program should be based on the hazards posed by the animals and materials used; on the exposure intensity, duration, and frequency; on the susceptibility of the personnel; and on the history of occupational illness and injury in the particular workplace. A health history evaluation is advisable before work assignment to assess potential risks for individual employees. Periodic medical evaluations and appropriate immunization schedules are advisable for some risk categories. Immunization of animal care personnel against tetanus is important.
In accordance with AAALAC's Three Primary Standards, assurance must be provided by an organization that all personnel at risk are appropriately considered under the occupational health and safety program.
In addition to using its AAALAC's Three Primary Standards, AAALAC International uses the guidance from the Centers for Disease Control and Prevention (CDC) B Virus (herpes B, monkey B virus, herpesvirus simiae, and herpesvirus B)*, last reviewed January 30, 2019; the "Biosafety in Microbiological and Biomedical Laboratories," 6th Edition (DHHS 2020); the "Occupational Health and Safety in the Care and Use of Research Animals," NRC 1997; and the "Recommendations for Prevention of and Therapy for Exposure to B Virus (Cercopithecine Herpesvirus 1)," Cohen, et al. (2002), Clinical Infectious Diseases 35:1191-1203) as resources for assessing the appropriateness of measures to protect personnel and prevent transmission of B Virus, Macacine alphaherpesvirus 1.
As recommended in the designated references above, macaques should be presumed to be harboring Macacine alphaherpesvirus 1 and handled accordingly. Each AAALAC International accredited institution housing macaques, or utilizing tissues or body fluids collected from macaques, must have a protection and prevention program for Macacine alphaherpesvirus 1 as a part of its occupational health and safety program.
The basic elements of the program include standard operating procedures and training for handling macaques and their tissues and dealing with potential exposures; risk assessment and education of all personnel having potential contact with macaques; the presence of supplies for immediate and appropriate patient first aid and animal specimen collection; maintenance of bite, scratch, exposure and incident log; the required use of appropriate protective equipment, including that necessary for hand and arm as well as for eye and mucous membrane protection; and access to occupational health and safety staff and medical care staff knowledgeable of both exposure and transmission risks and disease signs and symptoms.