Background and History
Prior to the middle of the 20th century the responsibility for animals used
in research in the United States was placed directly in the hands of the
researchers and the quality of animal care and animal welfare varied
tremendously among research institutions. Even within the same school
or institution, research laboratories had inconsistent animal care policies
and standards of care.
In 1961, a group of veterinarians working for research institutions in the
Chicago area formed the Animal Care Panel (ACP). The ACP appointed a
committee charged with establishing animal care and use guidelines for
research facilities. Their product was the publication of the first edition
(1963) of the Guide for the Care and Use of Laboratory Animals (referred to
in this document as the Guide). Subsequent editions of this publication
were supported by the NIH and developed under the auspices of the
Institute of Laboratory Animal Resources (ILAR), which was subsequently
renamed the Institute for Laboratory Animal Research. The National Acad
emy Press, under the auspices of the National Research Council, published
the most recent (seventh) edition in 1996. This single document serves as
the primary source of laboratory animal care and use standards and
guidelines in the United States. The 1996 edition has been translated
and published in six languages, and over 400,000 copies have been
distributed throughout the world.
In 1963, the ACP saw a need to evaluate the standards of animal care and
use practiced in research institutions based on the Guide, and appointed
an Animal Accreditation Committee. This Committee soon determined
that it should function independently of the ACP, and in 1965 incorporated
in the state of Illinois as the American Association for the Accreditation
of Laboratory Animal Care. This independent accrediting agency changed
its name in 1996 to the Association for the Assessment and Accreditation
of Laboratory Animal Care International (AAALAC).
Prior to 1966, no U.S. federal law addressed laboratory animal welfare.
Local humane societies actively promoted responsible treatment of pets
and farm animals. Concurrently, the scientific community was improving
the quality of animal care and well-being in the research laboratory. During
this time the increasing need for dogs and cats in research was partially
fulfilled by animal dealers who obtained these animals in various ways
and sold them to research laboratories. A series of articles and news
reports on animal neglect, abuse and pet theft by animal dealers culmi
nated in a 1966 major article and photographs in Life magazine. The article
suggested a need for regulation and a system of enforcement, especially
for dogs and cats used in research. Catalyzed in part by this article, the
Laboratory Animal Welfare Act, the first version of what is now known as
the Animal Welfare Act (AWA), was passed by Congress in 1966 (Public
Law 89-544) establishing legal standards for laboratory animal care and
use for the first time in this country. The United States Department of
Agriculture (USDA) was named the responsible agency for implementing
and enforcing this new law and it promptly began promulgating regula
tions. Research laboratories and dealers were required to register or license
their facilities and undergo inspection by USDA personnel who were
authorized to issue citations for non-compliance. These early inspections
did not extend into the research laboratory where animal care and use
remained under the direction of the research investigator. A number of
amendments to the AWA have led to regulations that now include animal
transportation, marine mammals, and animals in the research laboratory.
However, the USDA regulations currently exclude common laboratory rats
(Rattus norvegicus) and mice (Mus musculus), birds, and farm animals used
in production agriculture research.
All Public Health Service (PHS) policies on this subject evolved from the
1971 National Institutes of Health (NIH) Policy, “Care and Treatment of
Laboratory Animals.” That policy referenced several NIH and PHS state
ments on appropriate care and humane treatment of laboratory animals,
among them the Guide. It introduced the animal care committee as a
means of local assurance of good animal care and use.
The 1971 NIH policy required institutions or organizations using warm-
blooded animals in research or teaching supported by NIH grants, awards
or contracts to “assure the NIH that they will evaluate their animal facilities
in regard to the maintenance of acceptable standards for the care, use
and treatment of such animals.” The institution could show that it was
either accredited by a recognized professional laboratory animal accredit
ing body (AAALAC) or had established an animal care committee to carry
out that assurance function. The minimum number of committee members
was not stated, but at least one member had to be a Doctor of Veterinary
Medicine. Guidelines for the committee included the Guide, all applicable
portions of the AWA, and an appended set of Guidelines known as the
“Principles for the Use of Laboratory Animals.” The committee was required
