Summary

Consistent, high-quality animal care and use programs are critical to the research effort at several levels. In this chapter, we have presented three systems that affect the quality of such programs: the ISO process, AAALAC International accreditation, and GLP regulations.

Most developed countries have some form of national legislation dealing with the humane treatment of animals used for scientific purposes, thereby establishing a required minimum level of what might be termed "quality." Those planning to submit animal-related data to a national authority for premarketing approval must meet additional GLP regulatory requirements of the United States' FDA or the OECD.

A second driving force for quality in this area is an ethical imperative to care for and use animals in such a way that pain, distress, and discomfort are minimized to the greatest extent practicable. This includes recognizing that using animals in the advancement of science to improve human health is a privilege to be aware of at all times.

Third, high-quality animal care and use practices are important elements in producing statistically valid and reproducible scientific data. Through the application of uniform high standards in the areas of animal procurement, husbandry, veterinary care, and experimental use, animal-related variables may be minimized.

GLP regulations have the longest history of the three systems, with roots in the United States Food and Drug Act of 1906. The actual regulations were finalized in 1978, after being developed over several decades in response to harmful incidents involving human illnesses and deaths. The ISO process originated in 1946 and evolved from the recognition that uniformity of industrial standards on an international basis would facilitate global cooperation and trade. AAALAC International traces its origins to the late 1940s, when rapid expansion of research involving animals led laboratory-animal scientists to recognize the need for standardized practices of animal care.

The recently consolidated ISO 9000-2000 is the ISO standard most applicable to animal care and use programs, as it deals broadly with management systems. Recognizing that a high-quality animal care and use program involves a successful management system, ISO 9000-2000 can be readily applied to such programs. Key elements of ISO 9000-2000 are the product produced and consumer satisfaction with the product. For animal care and use programs, the product may be healthy animals or the service of providing their care. Implementation of ISO 9000-2000 involves putting in place procedures that meet ISO's detailed standards, conducting an extensive self-assessment and, if desired, certification by an external organization.

AAALAC International is a nonprofit corporation governed by a board of trustees that represents a broad cross-section of scientific, professional, and other nonprofit organizations interested in animal welfare in science. Using science-based standards, including the Guide for the Care and Use of Laboratory Animals and additional international Reference Resources, AAALAC International conducts on-site evaluations of animal care and use programs. A pre-site visit self-assessment by the applicant organization serves as the starting point for discussions during the on-site part of the accreditation process. The site-visit team includes at least two expert peer-reviewers, including one from AAALAC International's Council on Accreditation, to which the site visit report is presented for a final determination of accreditation status. Several categories of accreditation are possible for new applicants and pursuant to re-visits, which take place every three years.

Regulatory compliance for organizations conducting animal studies in support of products destined for consumers involves meeting stringent national or international GLP regulations. Hallmarks of GLP regulations are internal controls and documentation. QA units within the organization — required by GLPs — not only oversee schedules and protocols, but conduct periodic inspections to ensure adherence to study elements and other GLP requirements. The aspects of GLPs that relate specifically to animal care and use are basic, and deal principally with procurement, husbandry, and veterinary care. What sets GLP regulations apart from the other assessment systems described in this chapter is their strong emphasis on SOPs and documentation. Verification of adherence to GLPs is through internal oversight mechanisms and unannounced audit inspections by officials from regulatory authorities.

Although they represent three distinct assessment systems, ISO registration, AAALAC International accreditation, and compliance with GLP regulations should be considered complimentary and not in an "either/or" manner. Integration of all three systems into institutional animal care and use programs, when appropriate (for instance, when GLP compliance is legally required), serves to enhance the quality of the overall program. Each system focuses on a different aspect of the use of animals in the advancement of science, and each employs a unique approach to verifying that institutions are meeting its requirements. A key component of many animal care and use programs is the committee charged with oversight responsibilities, known as the Ethics Committee, Animal Care and Use Committee, Ethical Review Processes, or other names. In addition to serving as another form of internal quality monitoring, these bodies provide a natural locus for integration of the three systems into an overall institutional program.

The histories of the three systems presented are instructive in understanding their differences and how they may fit together as a whole. Questionable and even deadly practices in industry led to GLP regulations designed to reduce risks to humans. These regulations took the form of strict compliance with highly prescriptive record keeping and other documentation requirements. This emphasis on consistent, well-documented internal procedures and controls is highly congruent with the ISO 9000-2000

system, which grew from its founders' desire to facilitate uniformity through adherence to international standards. Animal care and use programs operating under ISO 9000-2000 rely on frequent feedback from "customers," i.e., scientists using animals, to continuously improve the quality of service provided and management of the overall program. Rooted in the desire to improve laboratory animal care, AAALAC International focuses specifically on institutional mechanisms and practices that directly affect animal welfare. Due to great variations in species, and even individual animals, evaluating animal welfare is best done through the application of outcome- or performance-based standards, rather than through a prescriptive, means-based approach. To accomplish this, AAALAC International involves expert peer-reviewers in on-site evaluations of animal care and use programs, facilities, and the animals themselves.

Organizations that consistently apply well-documented, high-quality management practices (such as those promoted by GLP and ISO) that are also responsive to the needs of animals will find achieving AAALAC International accreditation a natural next step. Thus, far from being exclusionary, the three assessment systems presented here can work in concert to improve the quality of all aspects of animal care and use programs.

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