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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 Ani- mal Science (FELASA/ICLAS) meeting in Como, Italy, ILAR and the Interna- tional Association of Colleges of Laboratory Animal Medicine (IACLAM) in- vited representatives of laboratory animal medicine organizations from around the world to meet and initiate a dialogue about appropriate veterinary care stan- dards 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 Medi- cine (ACLAM), Canadian Association of Laboratory Animal Medicine (CALAM/ACMAL), India’s Committee for the Purpose of Control and Supervi- sion of Experiments on Animals (CPCSEA), European College of Laboratory Animal Medicine (ECLAM), European Society of Laboratory Animal Veteri- narians (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 agen- cies, in the form of legislation, regulations, or policy, but also guidance derived from professional organizations primarily composed of laboratory animal vet- erinarians. 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 diver- sity of approach to these three points were described by the participating rep- resentatives, suggesting that harmonization is occurring in some areas of vet- erinary care while in others there remain differences, some of which could be quite significant. 95

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96 Animal Research in a Global Environment: Meeting the Challenges Qualifications of the Veterinarian Table 1 depicts the wide variety of degrees that denote training in veteri- nary 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 postgradu- ate 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 enhanc- ing their knowledge and expertise in the field. TABLE 1 Veterinary Degrees Granted Around the World Recognized Primary Veterinary Medical Degrees Granted Throughout the World (Primary Information Source – AVMA Listed Veterinary Colleges of the World) Countries Awarding Abbreviation Actual Veterinary Degree the Degree BS Bachelor of Science Afghanistan, Taiwan BSc Bachelor of Science China BASc Bachelor of Agricultural Science China BVM Bachelor of Veterinary Medicine China, Kenya, Libya, Taiwan, Uganda, United Kingdom, Zambia BVM&AR Bachelor of Veterinary Medicine Saudi Arabia and Animal Resources BVMS Bachelor of Veterinary Medicine Australia, Iraq, United Kingdom and Surgery – except Edinburgh University BVM&S Bachelor of Veterinary Medicine United Kingdom – Edinburgh and Surgery University only BVSc Bachelor of Veterinary Science Australia, China, Egypt, Japan, Myanmar, New Zealand, Sri Lanka, South Africa, Sudan, Syria, United Kingdom, Zimbabwe BVSc&AH Bachelor of Veterinary Science India and Animal Husbandry CMV Candidates Medicinae Veterinariae Norway D Dierenarts Netherlands DCV Doctor en Ciencias Veterinarias Argentina DEDV Diplôme d’Etat de Docteur Vétérinaire France DH Doktor Hewan Indonesia DK Diploma of Ktiniatrou Greece (continued)

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Standards of Veterinary Care for Laboratory Animals 97 TABLE 1 Continued Recognized Primary Veterinary Medical Degrees Granted Throughout the World (Primary Information Source – AVMA Listed Veterinary Colleges of the World) Countries Awarding Abbreviation Actual Veterinary Degree the Degree DMV Docteur en Médecine Vétérinaire Belgium, Tunisia, Zaire Dottore in Medicina Veterinaria Italy Doctor en Medicina Veterinaria Cuba, Dominican Republic, Ecuador, Paraguay, Uruguay Doctor Medic Veterina Romania Dr. vet. Med. Diplôme Fédéral de Médecin Vétérinaire Switzerland DV Docteur Vétérinaire Algeria, Morocco DVE Docteur Vétérinaire d’Etat Senegal DVM Doctor of Veterinary Medicine Bangladesh, Canada, Ethiopia, Hungary, Iran, Malaysia, Nigeria, Pakistan, Philippines, South Korea, Thailand, Tobago, Trinidad, United States, West Indies Doktor Veterinarske Medicine Bosnia and Herzegovina, Croatia, Serbia, Slovenia IASV Ingénieur Agricole Spécialité Vétérinaire Cambodia LMV Licenciado em Medicina Veterinaria Mozambique, Portugal LV Licenciado en Veterinaria Spain Legitimerad Veterinaer Sweden LVM Licentiate in Veterinary Medicine Finland LW Lekarz Weterynarii Poland MV Mjek Veteriner Albania Médico Veterinario Argentina, Bolivia, Brazil, Chile, Peru, Venezuela MVB Bachelor of Veterinary Medicine Ireland MVD Médico Veterinario Zootecnista Dominican Republic MVDr Doktor Veterinarstvi Czech Republic MVMVZ Médico Veterinario Zootecnista Colombia, Guatemala, Mexico SVM Specialist Veterinarnoj Medicini Ukraine T Tieraerzt Austria, Germany V Veterinario Brazil Veterinaereksamen Denmark VE Veterinary Engineer Viet Nam VetMB Bachelor of Veterinary Medicine United Kingdom VH Veteriner Hekim Turkey VL Veterinaren Lekar Bulgaria VMD Veterinariae Medicinae Doctoris United States – University of Pennsylvania only VV Veterinarnyi Vrac former Soviet Union Source: www.worldvet.org/docs/Global%20Vet%20Schools.pdf (accessed July 27, 2009).

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98 Animal Research in a Global Environment: Meeting the Challenges 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 direc- tion 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, ap- propriate 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 estab- lishment.” An approved amendment to Article 20 of the proposed revision fur- ther notes that “Member States shall ensure that, for the purposes of the authori- zation, 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 provi- sion 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 “appropri- ate” training and education will allow the veterinarian to provide sound guid- ance 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 [labora- tory] 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 re- quires 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) re- quires that a Doctor of Veterinary Medicine with training or experience in labo- ratory 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 pro- posed revision to the European Directive includes a requirement for the desig- nated veterinarian to serve on the ethical review committee as well as member- ship 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

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Standards of Veterinary Care for Laboratory Animals 99 (full or part time) with relevant training or experience in laboratory animal sci- ence 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 ex- amination, for example by ACLAM, ECLAM, the Japanese College of Labora- tory Animal Medicine (JCLAM), or the Korean College of Laboratory Animal Medicine. It may also be met by the FELASA Category D (Specialists) certifi- cate 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 ani- mal facility; b. Make provisions for the health and welfare of animals; c. Provide advice, instruction, and assistance to investigators on labora- tory animal–related matters and provide practical support of research programs; d. Ensure compliance with all the laws, regulations, and guidelines rele- vant 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 ex- ternal education programs in the humane care and use of laboratory animals, which continue to develop the concept of the Three Rs (Rus- sell 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 re- search 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 wel- fare 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 guide- lines. In summary, the consensus is that the veterinarian must have appropriate

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100 Animal Research in a Global Environment: Meeting the Challenges 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 var- ies among countries. Many guidelines and regulations do not describe expecta- tions for the veterinarian in any detail. What follows is a compilation of the nu- merous 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 pharma- cologic 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 institu- tion, quarantine and stabilization, health monitoring, preventive medicine, dis- ease surveillance, diagnosis, treatment, control of disease, surgery, pain and dis- tress, 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 re- ceive 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

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Standards of Veterinary Care for Laboratory Animals 101 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 un- derstand 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 responsi- bilities and expertise of that individual. Any consideration of harmonizing vet- erinary 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 (espe- cially online resources in a variety of languages). References CEC [Commission of the European Communities]. 2008a. Proposal for a Directive of the European Parliament and of the Council on the Protection of Animals Used for Scientific Purposes. Brussels. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do? uri=COM:2008:0543:FIN:EN:PDF (accessed July 27, 2009). CEC. 2008b. Report on the Proposal for a Directive of the European Parliament and of the Council on the Protection of Animals Used for Scientific Purposes. COM (2008)0543 – C6 - 0391/2008 – 2008/0211(COD). Committee on Agriculture and Rural Development. Rapporteur: Neil Parish. www.europarl.europa.eu/sides/get Doc.do?type=REPORT&reference=A6-2009-0240&language=EN (accessed July 27, 2009). EEC [European Economic Community]. 1986. Council Directive 86/609/EEC of 24 No- vember 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes, Brussels. http://eur-lex.europa.eu/LexUriServ/LexUriServ. do?uri=CELEX:31986L0609:EN:HTML (accessed July 28, 2009). Home Office. 1985. Scientific Procedures on Living Animals (Cmnd. 9521). London: Her Majesty’s Stationery Office. www.archive.official-documents.co.uk/document /hoc/321/321-xa.htm (accessed July 28, 2009). NACLAR [National Advisory Committee for Laboratory Animal Research]. 2004. Guidelines on the Care and Use of Animals for Scientific Purposes. Singapore. www.ava.gov.sg/NR/rdonlyres/C64255C0-3933-4EBC-B869-84621A9BF682/833 8/Attach3_AnimalsforScientificPurposes.PDF (accessed July 28, 2009). 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_ex p/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.