THE MERCK VETERINARY MANUAL
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Regulatory Requirements for Laboratory Animals

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Most American laboratories must adhere to two 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(AWA; created in 1966) and the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy; originally enacted in 1985).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, except for 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 ensuring 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 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 8th edition, was last revised in 2011. 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; timely reporting of all incidents of noncompliance; and site visits for-cause or other purposes. Failure to adhere to PHS Policy can result in revocation of federal funding for some or all research projects at the institution.

The 8th edition of the Guide for the Care and Use of Laboratory Animals, released in 2011, at 220 pages represented a 76% increase in information, guidance, and prescribed action from the content of the 7th edition (1996). It is organized into five chapters that cover the subject areas of (1) key defining concepts, including applicability, a brief review of the ethical principles in the humane care and use of animals in research, and clarifying definitions; (2) articulation of the basics of an animal care and use program, most prominently oversight structure, salient aspects of safety, and requirements for training; (3) the environment, housing, and management of research animals; (4) veterinary care; and (5) animal research facility design and physical plant operation. While there were abundant changes in the Guide from the 7th to 8th edition, most momentous were the unprecedented responsibility delegated to the attending veterinarian (AV) for the welfare of any animal in research at all times during experimentation and in all phases of the animal's life and in establishing the unambiguous and absolute authority of the AV to prescribe treatment and other interventions, including removal of subjects from experimentation. Other significant additions addressed the accordance of cage space allocated to breeding rodents, the genetic management of rodent breeding colonies to ensure authenticity, the care of aquatic species, and an enhanced emphasis on the training of personnel when applicable in proper animal care and methods of use, particularly in aseptic surgery and humane euthanasia technique.

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 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 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 to a comprehensive emergency operations and disaster responsiveness plan.

Last full review/revision June 2013 by Michael J. Huerkamp, DVM, DACLAM

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