AAALAC International relies on Three Primary Standards used by the Council to evaluate programs: the Guide for the Care and Use of Laboratory Animals (the Guide, NRC 2011); the Guide for the Care and Use of Agricultural Animals in Research and Teaching (the Ag Guide, FASS 2010); and the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes, Council of Europe (ETS 123). AAALAC has modified its position statements to reflect changes in the 2011 Guide. The following positions will be used by the Council on Accreditation to evaluate and accredit animal care and use programs.
Definition of "Laboratory Animals"
AAALAC International defines "laboratory animals" as any live vertebrate animal (and any other animal designated by applicable legislation) used or intended for use in research, testing, or teaching. For accreditation purposes, the definition is not limited by the type of housing enclosure (e.g., cage, pen, paddock, pasture, tank, raceway, etc.). All such animals owned by the accreditable unit are to be included in the Program Description and will be evaluated by AAALAC International.
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The Attending Veterinarian and Veterinary Care
The animal care and use program is the collaborative responsibility of the Institutional Official, the Attending Veterinarian, and the IACUC (or comparable oversight body). The Attending Veterinarian is responsible for the well-being and clinical care of animals used in research, testing, teaching, and production. This responsibility extends to monitoring and promoting animal well-being at all times during animal use, and during all phases of the animal's life. It is expected that the program of veterinary care will uphold the highest standards of care and ethics. Moreover, the veterinarian must have sufficient authority, as provided by the institution, to treat an animal and institute appropriate measures to relieve severe pain or distress, including euthanasia. In fulfilling these duties in a research environment, the Attending Veterinarian 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 Attending Veterinarian 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 Attending Veterinarian, under the oversight of the Attending Veterinarian. Important aspects of the role of the Attending Veterinarian and the program of veterinary care typically include the following:
- Veterinarians providing clinical and/or program oversight and support must have experience, training, and expertise necessary to appropriately evaluate the health and well-being of the species used, in the context of the animal use being carried out by the institution.
- The Attending Veterinarian must have access to all animals.
- There must be timely provision of veterinary medical care, and emergency veterinary care must be available at all times, including after work hours, on weekends, and on holidays.
- The Attending Veterinarian must have oversight of additional aspects of the veterinary care program, such as preventative medicine and health surveillance, medical treatment, establishment of sedation, anesthetic and analgesic guidelines, handling, and immobilization, and should have oversight of other related aspects such as housing and husbandry.
- The Attending Veterinarian should provide guidance and oversight to surgery programs and perioperative care.
- Professional veterinary staff should remain knowledgeable about the latest practices and procedures to ensure that high quality care is provided to animals.
- If there is no full-time Attending Veterinarian on-site, there must be a designated person who is responsible for daily animal care and use and facility management.
In addition, the Attending Veterinarian or designee has further responsibilities related to his/her role on the IACUC. For example:
- There should be regular, clear communication between the Attending Veterinarian and the IACUC, and animal program needs should be regularly and clearly communicated to the Institutional Official by the Attending Veterinarian.
- The veterinarian should have input in protocol review, the development of study removal criteria, and responsible conduct of research activities.
- The veterinarian and/or individuals providing care to animals should understand the potential for adverse clinical complications that may arise from experimental procedures.
- The IACUC, in association with the Attending Veterinarian, has the responsibility for determining that personnel performing surgical procedures are appropriately qualified and trained in the procedures to be performed.
- The IACUC, in cooperation with the veterinarian, should be involved in classifying major versus minor surgical procedures.
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Cage or Pen Space
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.
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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.
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Selecting the Appropriate Standard(s) for the Care and Use of Agricultural Animals
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.
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Safety Requirements for Walk-In Cage/Rack Washers and Bulk Sterilizers
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:
- buddy system, in which at least two individuals are present when the washer is started, with the intent that one of them will always remain outside of the washer/sterilizer and ensure that no one is inside upon activation of the wash cycle;
- explosion relief door latches which open easily from the inside of the washer;
- lock-out system, whereby the emergency stop mechanism, once activated, must be actively disengaged before the machine can be restarted.
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.
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Occupational health & safety program
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.
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Macacine herpesvirus 1 (or Herpes B virus)
In addition to using its AAALAC's Three Primary Standards, AAALAC International also uses "Occupational Health and Safety in the Care and Use of Research Animals," NRC 1997; "Recommendations for Prevention of and Therapy for Exposure to B Virus (Cercopithecine Herpesvirus 1)," Cohen, et al. (2002), Clinical Infectious Diseases 35:1191-1203; and the report "Biosafety in Microbiological and Biomedical Laboratories," 5th Edition (DHHS 2009) as resources for assessing the appropriateness of measures to protect personnel and prevent transmission of Macacine herpesvirus 1.
As recommended in the designated references above, macaques should be presumed to be harboring Macacine herpesvirus 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 herpesvirus 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 a bite, scratch, 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 risk and acute disease.
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