Background

The three systems to be discussed here each occupy an individual niche in promoting and assuring quality animal care and use practices. To understand both the functions of each system and the nature of their niches, it is useful to examine how each was conceived and developed.

History of ISO

In the book, Friendship among Equals, by Jack Latimer,5 one of the founders of ISO, Willy Kuert, writes,

ISO was born from the union of two organizations. One was the ISA (International Federation of the National Standardizing Associations), established in New York in 1926, and administered from Switzerland. The other was the UNSCC (United Nations Standards Coordinating Committee), established in 1944, and administered in London.

The conference of national standardizing organizations [that] established ISO took place in London from 14 to 26 October, 1946.

The result of this founding meeting of delegates from 25 countries was the creation of a new international organization, "the object of which would be to facilitate the international coordination and unification of industrial standards"; in other words, to ease the movement of goods (or services) across international boundaries. The new organization, ISO, which began functioning officially on February 23, 1947, has evolved to become a worldwide federation of national standards bodies from 140 countries.6 Literally hundreds of ISO standards exist that define the requirements for everything from foods to film speed. In fact, many of us will recognize the film-speed measurement called ISO 100, ISO 200, and so on.

The mission of ISO is "to promote the development of standardization and related activities in the world with a view toward facilitating the international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological, and economic activity. ISO's work results in international agreements, which are published as International Standards."6 Further, ISO defines its standards as documented agreements containing technical specifications or other precise criteria to be used consistently as rules, guidelines, or definitions of characteristics, to ensure that materials, products, processes, and services are fit for their purpose.7 ISO standards cover a huge area of subjects. The subject of most interest and applicability for our purposes is that of "quality requirements in business-to-business dealings," which is covered in the ISO 9000-2000 standard.

History of AAALAC International

The origin of AAALAC International can also be traced to the WWII period. The postwar boom in science, including the dramatic growth in public funding of research in the United States by the NIH, brought with it a commensurate burst of animal experimentation. So it was that in the late 1940s, five veterinarians involved in managing laboratory-animal facilities in major institutions in Chicago, Illinois, first met to discuss and share information about the care of laboratory animals. Before the end of the decade, a movement emerged from this group to form a national organization to address the issues facing the growing field of laboratory-animal science.8

The first meeting of AAALAC International's progenitor, the Animal Care Panel (ACP), took place in 1950. At that meeting, Carl Schlotthauer of the Mayo Foundation emphasized the need to "establish some uniformity in animal handling."8 Although ACP members initially recognized the need for standards, certification, and accreditation, the organization struggled with how to implement such programs during the period between 1950 and 1960. As early as 1951, the ACP had a Committee on Animal Care Standards and a Committee on Regulations for the Care of the Dog, but it was not until 1958 that the committee finally decided that the ACP should undertake accreditation functions for laboratory-animal maintenance and care.

Finally, in the fall of 1964, a subcommittee of the ACP issued an in-depth report, Accreditation of Laboratory Animal Facilities, recommending establishment of an autonomous entity (not part of the ACP) to conduct an accreditation program. The American Association for Accreditation of Laboratory Animal Care was established as a nonprofit corporation in April 1965.

History of GLP Regulations

Good Laboratory Animal Practice (GLP) regulations differ from ISO and AAALAC International in several basic ways. First, they are legal requirements, as opposed to the voluntary nature of ISO and AAALAC International. Second, they have their roots not in the hopes of scientists to better their professional specialties, but rather in governmental actions to prevent harm to the general public.

The United States FDA was created with the enactment of the Food and Drug Act of 1906. Its principal mission, then and now, is to protect consumers from harmful foods and drugs, which prior to that time were frequently misbranded and often impure. FDA's powers were expanded in 1938 in response to a 1937 incident in which an incorrectly labeled elixir sulfanilamide containing diethylene glycol killed 100 people in two months.9 And in 1962, another tragedy: the widespread and severe birth defects caused by the European approved drug thalidomide led to additional FDA powers to require manufacturers to prove effectiveness and provide post-approval reports.

However, it was actual criminal activities that brought about the GLP regulations. Audits authorized by the 1962 law showed that 618 of 867 studies were invalid because of numerous discrepancies between actual study procedures and data. As a result, the FDA prosecuted four individuals. These toxicology-testing laboratory managers were found guilty and sentenced to prison. The subsequent FDA decision to regulate laboratory testing resulted in proposed GLP regulations in 1976. These were finalized in 197810 and took effect in 1979. As knowledge and new technologies have grown, GLPs have been modified several times (in 1987 and 1999).

During this period, concerns about the safety of food and drugs were not confined to the United States. At the international level, the Organization for Economic Cooperation and Development (OECD) was working at the same time to develop guidance in this area. The OECD is comprised of 30 countries from Asia, Europe, North America, and the Pacific Rim whose goals are to "build strong economies in its member countries, improve efficiency, hone market systems, expand free trade, and contribute to development in industrialized as well as developing countries."11 In addition to the 30 members, OECD has active relationships with 70 additional countries and many nongovernmental organizations (NGOs), giving it a truly global influence. An integral part of its 1981 "Council Decision on the Mutual Acceptance of Data in the Assessment of Chemicals" was the establishment of the OECD "Principles of GLP," which were subsequently revised in 1997.11 To further ensure harmonization of the procedures related to GLP compliance-monitoring in preclinical safety studies, the OECD developed guidance documents that strive to ensure that studies are carried out according to the "Principles of GLP." These include a 1989 council decision, "Recommendation on Compliance with Good Laboratory Practice," which requires the establishment of national compliance-monitoring programs based on laboratory inspections and study audits, and recommends the use of the "Guide for Compliance-Monitoring Procedures for Good Laboratory Practice" and "Guidance for the Conduct of Laboratory Inspections and Study Audits." Both these guidance documents were revised in 1995.11

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