Animal Research in a Global Environment: Meeting the Challenges: Proceedings of the November 2008 International Workshop (2011)

Standards of Veterinary Care for Laboratory Animals

Kathryn Bayne

In June 2007, in association with the Federation of European Laboratory Animal Science Associations and the International Council on Laboratory Animal Science (FELASA/ICLAS) meeting in Como, Italy, ILAR and the International Association of Colleges of Laboratory Animal Medicine (IACLAM) invited representatives of laboratory animal medicine organizations from around the world to meet and initiate a dialogue about appropriate veterinary care standards for laboratory animals. Participants included individuals knowledgeable in regulations and guidelines pertaining to veterinary care of laboratory animals from organizations such as the American College of Laboratory Animal Medicine (ACLAM), Canadian Association of Laboratory Animal Medicine (CALAM/ACMAL), India’s Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), European College of Laboratory Animal Medicine (ECLAM), European Society of Laboratory Animal Veterinarians (ESLAV), FELASA, Singapore’s National Advisory Committee on Laboratory Animal Research (NACLAR), and the United States Department of Agriculture (USDA).

The sources of the various international standards were reviewed and summarized. These sources include standards established by government agencies, in the form of legislation, regulations, or policy, but also guidance derived from professional organizations primarily composed of laboratory animal veterinarians.

Based on presentations summarizing those guidelines and regulations, three main themes of interest could be distilled from the discussions: (1) the qualifications of the veterinarian, (2) the authority of the veterinarian within the program, and (3) the role of the veterinarian. Both convergence and diversity of approach to these three points were described by the participating representatives, suggesting that harmonization is occurring in some areas of veterinary care while in others there remain differences, some of which could be quite significant.

Qualifications of the Veterinarian

Table 1 depicts the wide variety of degrees that denote training in veterinary medicine. Some are bachelor’s degrees in veterinary medicine or veterinary science, others are doctorate degrees. Some reflect two years of undergraduate education, others four or more years of undergraduate and graduate education. Some degrees include coursework in laboratory animals, or even a “track” in research, others do not. This range of training may be augmented by postgraduate education or it may not—depending on the country’s available educational opportunities. Some veterinarians working in laboratory animal medicine obtain on-the-job training at institutions outside their country, thereby further enhancing their knowledge and expertise in the field.

TABLE 1 Veterinary Degrees Granted Around the World

To illustrate this point, the following descriptors of necessary veterinary qualifications are drawn from a sampling of different countries that may serve as a model for developing nations in terms of stipulating the precise qualifications of the veterinarian. The content of the veterinary care program under the direction of these individuals is remarkably consistent:

(1) The proposed revision to the European Directive 86/609/EEC (CEC 2008a) states: “To ensure the ongoing monitoring of animal welfare needs, appropriate veterinary care should be available at all times and a staff member should be made responsible for the care and welfare of animals in each establishment.” An approved amendment to Article 20 of the proposed revision further notes that “Member States shall ensure that, for the purposes of the authorization, the persons referred to in paragraph 1 have the appropriate veterinary or scientific education and training and have evidence of the requisite competence” (CEC 2008b).

(2) The proposed revision to the Council Directive builds on the current Directive (EEC 1986), which states: “persons who take care of animals used for experiments, including the duties of a supervisory nature, shall have appropriate education and training…. Adequate arrangements shall be made for the provision of veterinary advice and treatment…. A veterinarian or other competent person should be charged with advisory duties in relation to the well-being of animals.” Although this language is not very specific, it is clear that “appropriate” training and education will allow the veterinarian to provide sound guidance and treatment for the care and use of animals.

(3) The United Kingdom’s Animals (Scientific Procedures) Act (Home Office 1985) stipulates that “the well-being and state of health of such [laboratory] animals are monitored by a suitably qualified person in order to prevent pain or avoidable suffering, distress or lasting harm.” The A(SP)A further requires that “no place shall be specified in a project license or as a breeding site unless it is so designated by a certificate, which in turn requires a veterinary surgeon or other suitably qualified person to provide advice on animal health and welfare.”

(4) The section of the USDA regulations (USDA 1991) that addresses membership of the institutional animal care and use committee (IACUC) requires that a Doctor of Veterinary Medicine with training or experience in laboratory animal science and medicine serve as a member of the committee. Under the section on veterinary care, the regulations require that the personnel involved in animal care and use be qualified to perform their duties. Similarly, the proposed revision to the European Directive includes a requirement for the designated veterinarian to serve on the ethical review committee as well as membership of “the person responsible for the welfare and care of the animals in the establishment.”

(5) Singapore has established excellent standards for the credentials of the veterinarian associated with a laboratory animal program. The NACLAR (2004) Guidelines state that “every licensee shall employ an Attending Veterinarian

(full or part time) with relevant training or experience in laboratory animal science and medicine. The veterinarian must also be licensed by the Agri-Food and Veterinary Authority (AVA).”

(6) The Guide for the Care and Use of Laboratory Animals (NRC 1996) was the most specific of the guidelines discussed during the roundtable. The Guide makes it quite clear that “A veterinary care program is the responsibility of the Attending Veterinarian who is certified or has training or experience in laboratory animal science and medicine or in the care of the species being used.” The reference to certification in the Guide may be met by specialty board examination, for example by ACLAM, ECLAM, the Japanese College of Laboratory Animal Medicine (JCLAM), or the Korean College of Laboratory Animal Medicine. It may also be met by the FELASA Category D (Specialists) certificate of competence. The individual certified at this level must be able to do the following (USDA 1991):

a.   Manage all animal, human, and physical resources in a laboratory animal facility;

b.   Make provisions for the health and welfare of animals;

c.   Provide advice, instruction, and assistance to investigators on laboratory animal–related matters and provide practical support of research programs;

d.   Ensure compliance with all the laws, regulations, and guidelines relevant to the production, maintenance, and use of laboratory animals and related to management of the animal facility;

e.   Be responsible for the development and presentation of internal and external education programs in the humane care and use of laboratory animals, which continue to develop the concept of the Three Rs (Russell and Burch 1959);

f.   Contribute to the in-depth development of innovative concepts in the humane care and use of laboratory animals, including carrying out research in laboratory animal science.

Thus, Category D includes veterinarians and other professionals of similar qualification. A third example is the certificate in laboratory animal medicine conferred on Canadian veterinarians.

Authority of the Veterinarian

Although this is one of the most important aspects of the veterinary care program, most countries do not describe in detail (or sometimes even mention) the authority the veterinarian must have to ensure good animal health and welfare in the laboratory animal care and use program. However, when the topic is addressed, there is a great deal of general convergence among the various guidelines. In summary, the consensus is that the veterinarian must have appropriate

authority to execute the duties inherent in ensuring the adequacy of veterinary care and in overseeing other aspects of the program of animal care and use.

Role of the Veterinarian

Multiple roles are attributed to the veterinarian, and the scope of these varies among countries. Many guidelines and regulations do not describe expectations for the veterinarian in any detail. What follows is a compilation of the numerous roles defined for the laboratory animal veterinarian.

Often, the veterinarian is referred to as an advisor. The veterinarian may be expected to give guidance regarding surgical techniques, selection of pharmacologic agents, selection of animal models, periprocedural care, euthanasia, and/or training of other individuals in the program (to name a few key areas). Occasionally, this advisory role is augmented to an oversight role, particularly in the United States, where the veterinarian would have an oversight role through his or her function on the institutional animal care and use committee.

As might be expected, the role of the veterinarian in ensuring the health and well-being of the animals used for research, testing, or teaching is a point of convergence among the various regulatory and guidance documents. The source of the animals and transportation of those animals from that source to the institution, quarantine and stabilization, health monitoring, preventive medicine, disease surveillance, diagnosis, treatment, control of disease, surgery, pain and distress, medical records, euthanasia, and/or other clinical duties are listed as key responsibilities of the veterinarian.

Adjunctive roles of the veterinarian include participating in the training of staff; providing expert guidance to the occupational health and safety program (e.g., about zoonotic diseases, animal allergens, and other conditions); advising on biological and chemical hazard policies of the institution; monitoring and advising on hygiene standards; providing guidance on animal facility design; and providing input into the development of the disaster plan.

The Como meeting highlighted two common systems used internationally for the oversight of animal health and welfare: one relies on a veterinarian and supporting animal care staff, and an equally vibrant system in several parts of the world relies on someone other than a veterinarian who has the requisite expertise (e.g., in the species of animals used, the type of research, laboratory animal science), such as a scientist. In the latter system, the veterinarian often has a secondary role in terms of authority and responsibility. Not unexpectedly, these different systems may be correlated with significant differences in the education and qualifications of the veterinarian, as well as his/her authority and role in the program. Individuals who work in countries where the veterinarian has more primary responsibility for animal health and welfare are likely to receive a more extensive education (through the veterinary curriculum and/or postgraduate training and certification) and are more often considered partners in the research enterprise. In countries where the veterinarian serves in a more

technical role, the lead scientist often has primary responsibility for animal care and use oversight.

Elucidation of international similarities and differences in the qualifications, authority, and role of the veterinarian in animal research programs will facilitate efforts to harmonize standards of animal care and welfare. It is important to understand the cultural and regulatory framework in which veterinarians work around the world, as well as the educational opportunities available to them. We should be familiar with the type of education and postgraduate experience achieved by the veterinarian to better gauge our expectations for the responsibilities and expertise of that individual. Any consideration of harmonizing veterinary care should include an assessment of the veterinary school curriculum, opportunities for postgraduate training (either in-country or outside the country), the country’s regulatory requirements, and training material resources (especially online resources in a variety of languages).

References

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NRC [National Research Council]. 1996. Guide for the Care and Use of Laboratory Animals. Washington: National Academy Press. www.nap.edu/readingroom/books/labrats/ (accessed July 28, 2009).

Russell W, Burch R. 1959. The Principles of Humane Experimental Technique (2nd ed, 1992 UFAW). London: Methuen. http://altweb.jhsph.edu/publications/humane_exp/het-toc.htm (accessed July 28, 2009).

USDA [US Department of Agriculture]. 1991. Code of Federal Regulations, Title 9, Part 3, Animal Welfare; Standards; Final Rule. Federal Register 56(32):1-109.