Regulatory Requirements for Laboratory Animals

The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs, was incorporated in 1965. More than 890 companies, universities, hospitals, government agencies, and other research institutions in 37 countries have voluntarily earned AAALAC accreditation as of 2013. Institutions that seek AAALAC accreditation are subject to comprehensive peer review of their animal care and use program every 3 years; this accreditation is given credence by the National Institutes of Health as a means of demonstrating compliance with PHS Policy.

Under provisions of the AWA, all persons who use animals in research or for exhibition, sell them at the wholesale level, or transport them in commerce must have established programs of veterinary care and animal husbandry. APHIS requires the owner of each licensed and registered facility to define a program of veterinary care (PVC), including the employment of an AV. In cases in which the AV is not a full-time employee, the facility owner must prepare a written PVC and schedule an appropriate frequency of visits by the AV. These visits must be on at least an annual basis. Whatever the employment arrangement, the facility owner must give the AV sufficient authority to ensure adequate veterinary care. The PVC must incorporate appropriate facilities, personnel, equipment, and services to meet this standard; ensure the availability of emergency, weekend, and holiday care for animals; include the requirement for the daily observation of all animals by employees to assess the animals’ health and well-being; and define channels for the direct and frequent communication between facility personnel and the AV.

Responsibilities of the AV include using suitable methods to prevent, control, diagnose, and treat diseases and injuries; providing adequate guidance and training of personnel who care for animals regarding handling, immobilization, anesthesia, analgesia, tranquilization, and euthanasia; and ensuring that the pre-procedural and post-procedural care of animals is in accordance with established veterinary medical and nursing procedures. Beyond these general responsibilities, the AV is responsible for reviewing the facility’s PVC at least once a year to ensure that the following meet contemporary standards of veterinary care for each species: vaccinations, handling of biologics and drugs, product safety assurance, parasite control, emergency care, euthanasia methodology, nutrition, pest control and product safety, quarantine procedures, exercise (dogs only), environmental and social enrichment (nonhuman primates only), water quality (when marine mammals are involved), and, for wild or exotic animals, capture and restraint methods.

Since 1985, the AWA and PHS Policy have required that Institutional Animal Care and Use Committees (IACUC) oversee not only the care, but also the use, of animals in research. The responsibilities of the IACUC are delineated in these laws and the associated federal policy and regulations. According to the AWA, the IACUC must consist of at least one veterinarian with training in laboratory animal science and expertise in the species under consideration, at least one practicing research scientist, and at least one person not affiliated with the institution. The PHS Policy requires a minimum of five members, including at least one of each of the following: veterinarian, scientist, nonscientist, and nonaffiliated member.

Each IACUC has three main areas of responsibility: review of research protocols; semiannual evaluations of the institution’s animal care and use, which includes inspections of animal housing areas and laboratories where animal procedures are performed; and judiciary activities such as investigating animal welfare concerns and adjudicating disagreements. Review of research protocols by the IACUC involves considering the merits of the animal study in the context of a broad range of complex, scientific, animal welfare, and veterinary topics. The IACUC also has the responsibility to monitor the compliance of ongoing studies and the authority to suspend research not performed in accordance with the conditions or with unforeseen negative consequences. Since 1985, the IACUC has been the primary means of animal welfare oversight within research institutions in the USA.

History shows that animal research facilities are regularly and often unpredictably subject to the effects of natural events, manmade actions, or failures of technology that imperil animals, experiments, and facilities. While principles of disaster preparedness and response have been integral to the Guide since its 7th edition, in 2013 the USDA instituted requirements for emergency and disaster preparedness and response plans and mandated training programs for appropriate personnel. As such, the Guide and USDA policy in conjunction make it mandatory that each institution craft and train personnel in a comprehensive emergency operations and disaster responsiveness plan.