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National Research Council (US) Institute for Laboratory Animal Research. The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. Washington (DC): National Academies Press (US); 2004.

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The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop.

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AAALAC International Perspective

John G. Miller

The Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International is a not-for-profit corporation established in 1965 as the American Association for Accreditation of Laboratory Animal Care. From its inception, AAALAC has had sound science as a principal focus. A 1964 report of AAALAC's predecessor, the Animal Care Panel, included the following statements: “As part of the scientific community, the Animal Care Panel has been working to define the conditions of animal care which promote sound and proper animal experimentation. … The Animal Care Panel cannot and will not proceed with this program [accreditation] without the consent and support of the scientific community.” AAALAC's current mission statement continues this emphasis on science, stating that the organization's purpose is to “enhance the quality of research, teaching and testing by promoting humane, responsible animal care and use.”

It is most appropriate that ILAR host this meeting, because the animal care and use standard most widely known in the global laboratory animal science community is ILAR's Guide for the Care and Use of Laboratory Animals (Guide). AAALAC is proud to have developed the first edition of the Guide, under a 1962 contract from the National Institutes of Health (NIH). Serving as the principal standard used by both AAALAC and the US Public Health Service (PHS) in evaluating animal care and use, each of the seven editions of the Guide has been developed by scientists, with its guidance based on “published data, scientific principles, expert opinion and experience with methods and practices that have proved to be consistent with high-quality, humane animal care and use.” This hierarchy of scientific support for its recommendations, from peer-reviewed data to experiential evidence, has been a hallmark of the Guide and has undoubtedly contributed to its widespread acceptance by the laboratory animal and more general scientific communities. Its utility as an international standard is demonstrated by the fact that the English version has been translated into nine additional languages.

As noted above, the Guide is the principal standard used by both AAALAC and the PHS, with both applying its provisions to all vertebrate animals. When one considers the number of animals being used at academic and other institutions that receive support from the NIH and other PHS agencies, and the fact that all major US pharmaceutical companies and commercial suppliers of animals are accredited by AAALAC, it is reasonable to estimate that 90% or more of the research animals in the United States are cared for and used in programs that apply the standards of the Guide. This percentage is likely higher for laboratory mice and rats, and refutes the claims of those who state that because the US Department of Agriculture's (USDA's) Animal and Plant Health Inspection Service does not “regulate” mice and rats, these species are not “protected” in the United States.

For nearly the first 15+ years of its existence, AAALAC accredited animal care and use programs only in the United States. Its first accredited program outside the United States was just across the border in Canada, but in 1986 Europe was included with the addition of a program in the United Kingdom. In 1996, the AAALAC Board of Trustees approved a new Strategic Plan that called for significantly increased emphasis on accreditation of programs internationally. Following the directions of that plan has led to remarkable success, with accredited programs currently in 18 countries on five continents. A new AAALAC service, begun in 1997 and called the Program Status Evaluation, has taken AAALAC representatives to additional countries, where institutions are striving to understand the accreditation process and bring their programs up to the AAALAC Standard. Through this international growth, AAALAC has had the opportunity to observe and evaluate programs from the Netherlands to the Philippines, and from Indiana to India. This experience has placed all of us involved with AAALAC, including the Executive Office staff, Council on Accreditation, and ad hoc consultants, in the position of de facto harmonization of different animal care and use standards into the referenced AAALAC Standard above.

AAALAC employs a variety of existing standards and related guidance in its assessment of animal care and use programs. As already mentioned, the Guide is our principal standard, and we apply its provisions and principles worldwide. However, the Guide is intentionally written in general terms to allow flexibility in its application. Taken together with the Guide's emphasis on performance as a measure of successful application, situations naturally occur in which professional judgments regarding appropriate implementation may differ. To assist AAALAC evaluators in these situations and to provide guidance to prospective and current accredited units, we have developed a list of publications and other documents we term our “Reference Resources.” The full list is available at http://www.aaalac.org/resources.htm, and includes references from Europe and Canada, in addition to US resources. They provide more specificity than the Guide in a wide variety of areas, and in many cases provide examples of appropriate outcomes that are useful when applying the Guide's performance standards. The Reference Resources provide guidance in areas such as euthanasia methods (Report of the AVMA Panel on Euthanasia; Euthanasia of Experimental Animals (EC DGXI)); training (FELASA recommendations on the education and training of persons working with laboratory animals: Categories A and C); humane endpoints (Guidance document on the recognition, assessment, and use of clinical signs as humane endpoints for experimental animals used in safety evaluation (OECD)); and many more.

The Guide and AAALAC's Reference Resources share a very important common characteristic—both are science based. The process for adding references to our list requires that the Council on Accreditation vote approval before such addition. The key factor in the Council's consideration of a prospective reference is scientific documentation of its validity and value to an animal care and use program. This factor has led on occasion to the Council's disapproval of proposed resources in which, although originally science based, the supporting data are outdated. Similarly, existing references that have become outdated or have been super-ceded by newer science-based publications are removed and/or replaced.

Evaluating an entire animal care and use program requires more than the application of the provisions and principles of the Guide and Reference Resources. A review of the process by which AAALAC assesses and accredits programs in the United States and internationally also helps demonstrate the mechanisms by which the wide variety of local standards, guidance, and policies are harmonized through the accreditation process to result in a common AAALAC Standard.

In the United States and internationally, the legal and regulatory requirements applicable to the unit being evaluated constitute the baseline for accreditation. No program can receive AAALAC accreditation if it is in violation of the law. Thus, in the United States, all provisions of the Animal Welfare Act Regulations must be met for species covered by the USDA, and for units receiving PHS support, all elements of their Assurance of Compliance with the NIH Office of Laboratory Animal Welfare must also be met. Program elements are then evaluated based on the provisions of the Guide; and when necessary and appropriate, specific Reference Resources are used to evaluate performance outcomes in areas in which the Guide is nonspecific or institutionally approved deviations from its recommendations have been employed. Critically important is that all principles of the Guide must be met. Finally, the expert professional judgment of the AAALAC Council on Accreditation is applied through a peer-review process, and a final accreditation status is granted.

Internationally the process is practically identical. Again, no program can become AAALAC accredited if it is in violation of local legal and regulatory requirements. Use of individuals as ad hoc consultants who are familiar with these local requirements facilitates uniform and appropriate interpretation and application to the unit. Once these local baseline requirements are shown to have been met, the Guide becomes the next standard to be applied. It is important to note that when local requirements are more stringent than Guide recommendations, the former must be met to achieve accreditation. In some instances, the Guide includes provisions not addressed in national or supranational animal welfare legislation or regulations, for example, in the area of occupational health and safety. In such cases, two options are available. (1) Other local requirements may exist outside the animal welfare area, as is the case with occupational health and safety requirements in the European Union (Council Directive on the Introduction of Measures to Encourage Improvement in the Safety and Health of Workers at Work (Directive 89/391/EEC). (2) In the absence of alternative local standards, the Guide standards are used as the basis for evaluating program elements in these areas. As AAALAC has grown internationally, we have conducted assessments in countries without national regulatory standards or other requirements for animal care and use. In these instances—just as in the United States—the Guide and Reference Resources serve as the basis for our evaluation. Finally, the application of expert professional judgment through the peer review process by the Council on Accreditation determines a program's final accreditation status. The key to maintaining consistency and uniformity of the AAALAC Standard across diverse international settings and standards is that all principles of the Guide must be met.

Notwithstanding the broad array of standards and guidance available in the area of animal care and use, circumstances occasionally arise for which there is no applicable published standard. In addition, professional judgments may differ regarding the acceptability of practices or procedures not specifically addressed in existing standards. In these circumstances, AAALAC again looks to science for solutions. In fact, the process used by AAALAC follows that used by ILAR in developing the Guide, that is, we look for published data in the area in question. When no relevant reports are located, scientific principles and expert opinion form the basis for resolution, with the final decision often informed by Council members' experience with proven methods or practices. An example of this process involves the use of alcohol as a disinfectant. The Guide states that “alcohol is neither a sterilant nor a high-level disinfectant,” yet it is used extensively for these purposes in rodent survival surgery. To answer questions about the suitability of such use, the Council formed a subcommittee to research and address this issue. Based on the information in six refereed scientific journal articles, two additional references, and the Manual of Clinical Microbiology, the Council determined that alcohol was acceptable as a skin disinfectant, but under certain circumstances may not be adequate to sterilize or disinfect surgical instruments. These determinations were published in the AAALAC newsletter, Connection, and became part of the AAALAC Standard.

Thus, the AAALAC Standard is not a static document. In fact, it is not based on a single document at all, but rather a compilation of many existing standards, guidelines, and policies that encompass all aspects of an animal care and use program. The majority of these are science based, a fact that not only gives credence to those, like the AAALAC Council on Accreditation, who interpret and apply them in an accreditation program, but also leads to the greater likelihood of acceptance and implementation by the scientists subject to their provisions. The AAALAC Standard is, therefore, an evolutionary product that is developing as internationally recognized standards are interpreted through the collective professional judgment of animal care and use experts and applied through an in-depth, multilayered, scientific peer-review process.

Before providing a list of areas in which I believe more science would be useful, I will comment on the modification of existing standards. It is my strong belief that when existing long-standing guidelines or requirements appear to be meeting the welfare needs of animals, any significant changes should meet three requirements: (1) the change must be of clear benefit to the animals; (2) it should not interfere unnecessarily with the research; and (3) it should be science based.

Finally, the following list comprises areas that I believe could benefit from additional scientific study and data. I provide them only as topics for consideration, with the hope that this workshop will serve as a venue for discussion.

  1. Enclosure dimensions;
  2. Wire-bottom cages;
  3. Environmental enrichment;
  4. Decapitation/cervical dislocation;
  5. Euthanasia in holding rooms;
  6. Species separation;
  7. Sanitation requirements; and
  8. Ventilation requirements.
Copyright © 2004, National Academy of Sciences.
Bookshelf ID: NBK25426

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