Most American laboratories must adhere to 2 main sets of animal welfare regulations: the Animal Welfare Act (AWA; created in 1966) and the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy; originally enacted in 1985).
The Animal and Plant Health Inspection Service (APHIS) of the USDA oversees enforcement of the AWA, which covers the care of research animals and includes guidelines for the oversight and conduct of experiments intended to minimize or prevent pain or distress of laboratory animals. The AWA also regulates zoos, exhibitors, animal dealers, and those who transport animals in commerce. All warm-blooded species are regulated by the AWA, whether alive or dead, with the exception of domestic mice and rats bred for scientific purposes, birds, and farm animals used in agricultural research. Provisions for veterinary care have existed under the AWA since 1970; requirements for exercise for dogs and ensuing the psychological well-being of nonhuman primates were added in 1985. The AWA is enforced through a self-reporting mechanism along with routine, unannounced inspections by APHIS. Failure to meet the requirements of the AWA can result in fines, citations, criminal proceedings, or revoked registration with disqualification to use AWA-regulated species in research.
The PHS Policy is based on a set of voluntary research animal care standards, the Guide for the Care and Use of Laboratory Animals, first published in 1963. The PHS Policy requires institutions to use this guide as a basis for developing and implementing institutional programs for research involving animals. The PHS Policy has been modified only once, in 2002, while the Guide, now in its seventh edition and last updated in 1996, is currently being revised under the auspices of the National Academy of Sciences, an independent advisory body to the federal government. The policy applies to all research institutions awarded federal grants and covers all vertebrate animals, not just those that are warm-blooded. Regulatory compliance is based on a system of self-regulation whereby institutions must provide to federal officials a written Animal Welfare Assurance that describes their compliance with the PHS Policy, updates via an annual report, and timely reporting of all incidents of noncompliance. Failure to adhere to PHS Policy can result in revocation of federal funding for some or all research projects at the institution.
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 750 companies, universities, hospitals, government agencies, and other research institutions in 29 countries have voluntarily earned AAALAC accreditation. 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 NIH 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 attending veterinarian (AV). In cases where the AV is not a full-time employee, the facility owner must prepare a written PVC and also 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 veterinarian 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 making sure 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 (where marine mammals are studied), and, for wild or exotic animals, capture and restraint methods.
Institutional Animal Care and Use Commit tee
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 5 members including at least one of each of the following: veterinarian, scientist, nonscientist, and nonaffiliated member.
Each IACUC has 3 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 done; 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 that is not done 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.
Last full review/revision July 2011 by Michael J. Huerkamp, DVM, DACLAM