History of Public Health Service Policy

Regulations have been promulgated by the PHS since 1935, originally through one of its constituents, the National Institutes of Health (Whitney). NIH guidelines have provided direction and recommendations for caring for and using laboratory animals at NIH. Subsequently, a committee of laboratory scientists assembled by the Institute of Laboratory Animal Resources of the National Research Council (NRC) wrote the Guide for the Care and Use of Laboratory Animals (NRC guide). First published in 1963 and updated many times since, this work has become the standard guide in the field. The first policy based upon the 1963 NRC guide came from NIH in 1971. The PHS published its first policy on animal care in 1973, with revisions in 1973, 1979, 1986, 1996, and 2002. Each successive revision increased the specificity and level of responsibility of animal-care committees in the supervision of animal use.

At the outset of NIH policymaking in animal care and use in 1971, all institutions and organizations using warmblooded animals for the purpose of research or other projects supported by NIH were required to give assurances that facilities for animals met "acceptable standards for the care, use, and treatment of such animals." This assurance could be met either by gaining accreditation through a professional laboratory-accrediting body (such as the Association for Assessment and Accreditation of Laboratory Animal Care International [AAALAC]) or by establishing a committee to evaluate the care and housing of animals used for NIH-sponsored activities. Institutions were also obligated to follow pertinent sections of the animal welfare regulations. In 1973, the NIH policy was replaced by the first of the PHS policies. Like the NIH policy preceding it, the first PHS policy required institutions either to be fully accredited or to have a standing institutional committee with a minimum of three members, including a veterinarian for those institutions using a "significant" number of animals. These committees were required to conduct periodic facility inspections, with the review of applications and proposals involving the use of animals considered optional.

The 1979 revision to the PHS policy required all institutions using animals, regardless of numbers used and accreditation status, to have a standing committee whose responsibility was oversight of the institution's animal-care program. In addition to the establishment of a committee of at least five members, including one veterinarian, the institution was obligated to establish a mechanism to review its facilities for warm-blooded animals for adherence to the principles contained in the NRC guide. The PHS policy recommended that AAALAC accreditation was the best means of satisfying this obligation, although periodic committee review of facilities and animals' care would suffice. Absent from the 1979 PHS policy was the requirement for review of individual proposals or projects, although review was encouraged. In 1986, however, the PHS policy was revised again, this time requiring the animal-care committees of institutions to take responsibility for specific organizational and supervisory duties in an effort to strengthen the system of institutional assurance.

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