Report of an animal welfare officer

1. Report of an animal welfare officer Fred Poelma, Ph.D. animal welfare officer Faculty of Veterinary Medicine Utrecht University, The Netherlands e-mail: f.g.j.poelma@uu.nl Workshop on Alternative Methods (3 R's) to Animal Tests

2. European regulations for the care and use of laboratory animals: Directive 86\609\EEC for the protection of animals used for experimental and other scientific purposes. Convention ETS 123 for the protection of animals used for experimental and other scientific purposes. Workshop on Alternative Methods (3 R's) to Animal Tests

3. The 45 member states of the Council of Europe The Council of Europe was set up to achieve a greater unity between its Members for the purpose of safeguarding and realising ideals and principles. (Human rights, environmental protection, bio-ethics, animal protection, …) Workshop on Alternative Methods (3 R's) to Animal Tests

4. The 27 member states of the European Union The aim of the EU is to eliminate disparities between laws, regulations or administrative provisions in the Member States… so as to avoid distortion of the competition or barriers to trade. Workshop on Alternative Methods (3 R's) to Animal Tests

5. Legislation in the Netherlands • Experiments on Animals Act (1977/1996) • ‘protect the laboratory animal’ • Principle: “no, unless…”, 3 R’s • Definitions: “what is an animal experiment?” • Persons involved: authorized and competent • Supervision: animal welfare officer (internal) inspector (external, Ministry of Public Health, Welfare & Sport) • Licenses (license holder; conduct of animal experiments, breeding and supply of laboratory animals, etc.) • Animal Ethics Committee (AEC) • Other Acts/regulations: health and welfare, housing, genetically modified organisms, etc. Workshop on Alternative Methods (3 R's) to Animal Tests

6. Some key figures in the Netherlands • 16 million people • 81 license holders (institutions) • 35 animal welfare officers (FELASA D) • 25 Animal Ethics Committees • 603.741 animal experiments in 2006 • 579.248 laboratory animals in 2006 • 523.956 (European registration, not included re-use and animals just killed) Workshop on Alternative Methods (3 R's) to Animal Tests

7. Purposes Animal Experiments in NL - 2006 • Science   275.017   45,6% • Drugs (medicines)    270.859   44,9% • Toxicity    33.038    5,5% • Education   15.504    2,5% • Diagnostics 9.287    1,5% • Other 36 Totally 603.741100% • Source: zo doende 2006 (www.vwa.nl) Workshop on Alternative Methods (3 R's) to Animal Tests

8. Laboratory animals used in NL in 2006 • Mice 47% • Rats 23% • Chickens 18% • Fish 3% • Monkeys 0,1% Workshop on Alternative Methods (3 R's) to Animal Tests

9. Primary legal task of the animal welfare officer • Supervision and monitoring the welfare of laboratory animals (Directive 86/609/EEC, Article 19.2d: “In user establishments a veterinarian or other competent person should be charged with advisory duties in relation to the well-being of the animals”) • Institution: University of Utrecht (UU) University Medical Centre Utrecht (UMCU) • 2 awo’s: Harry Blom Fred Poelma • embedded: Department of Animals, Science and Society Division of Laboratory Animal Science Faculty of Veterinary Medicine Utrecht University Workshop on Alternative Methods (3 R's) to Animal Tests

10. Department Animals, Science & Society • Ethology and Welfare [Prof.dr. B.M. Spruijt] • Laboratory Animal Science [Prof.dr. F. Ohl, chair] • Human – animal relationship [working group] • Netherlands Centre Alternatives to animal use (NCA) [Prof.dr. C.F.M. Hendriksen] Workshop on Alternative Methods (3 R's) to Animal Tests

11. Key figures 2006 UU and UMCU • 33.805 animal experiments • 2 license holders (UU and UMCU) • 3 AECs (different specialisations), monthly meeting • 700 AEC – protocols • 1200 detailed protocols (experimental design) • 280 animal caretakers, research technicians (FELASA A,B) • 670 scientists (FELASA C) • Research:Education: • Brain and behaviour Veterinary medicine • Infection and immunology Medicine • Surgery, orthopedics Biology • Endocrinology, cardiology, Pharmacology • anaesthesia, imaging techniques Workshop on Alternative Methods (3 R's) to Animal Tests

12. Tasks of an animal welfare officer • supervision and monitoring welfare of laboratory animals and quality of experiments • promotion of 3 R’s • education, FELASA C course (2 wk), practical courses students • advise scientists, AEC, license holders, animal technicians/caretakers • administration and registration of animal experiments and laboratory animals • registration of scientists and animal caretakers • public task: lectures at schools, tours in facilities, PR Workshop on Alternative Methods (3 R's) to Animal Tests

13. How does the awo perform his tasks at the UU/UMCU? • Advise scientists • increase quality of animal experiments (design, statistics, housing (enrichment), monitoring welfare, adequate anaesthesia and analgesia, humane endpoint, etc.) • pre-screening AEC protocol, detailed protocol, etc. • Advise License holders • quarterly meeting, report, PR • Advise Animal Ethics Committee • monthly meeting of 3 AECs, frequent communication with secretary of AEC • Site visits (14 sites in UU / UMCU) • Monthly site visit of each site, report/feedback to scientist and other responsable persons Workshop on Alternative Methods (3 R's) to Animal Tests

14. How does the awo perform his tasks at the UU/UMCU? • Advise laboratory animal facility managers • structurally monthly, informal weekly • Education • lectures on housing, monitoring welfare, humane endpoint, AEC-procedure, etc, in FELASA C course • coaching students in scientific practical courses • Research on Refinement • e.g. alternative bloodsampling techniques, alternatives for tailcutting in mice (genotyping), improve analgesia and anesthesia • Registration of experiments, animals and persons • annual meetings with departments/divisions Workshop on Alternative Methods (3 R's) to Animal Tests

15. title personnel: applying scientist (FELASA cat. C) lab. animal technician (FELASA cat. B) animal caretaker (FELASA cat. A) others (students, medical specialist) refereeing of scientific quality funding description of scientific problem aim of the study scientific relevance societal relevance Protocol-conducting animal experiment1. Ethics committee application formPart A (background information) Workshop on Alternative Methods (3 R's) to Animal Tests

16. species (strain) number housing conditions (mandatory in EU:group / solitairycage enrichment) choice of animal model alternatives (arguments underpinning need for animal use / reduction / refinement) arguments for number of animals required development / import of genetically modified animals (potential discomfort) 1. Ethics committee application formPart B (animals) Workshop on Alternative Methods (3 R's) to Animal Tests

17. 1. Ethics committee application formPart C (animal experiment) • concise protocol • description experimental design • estimation of level and description of discomfort per treatment / procedure • duration ofdiscomfort • description of anaesthesia / analgesia • arguments for not using anaesthesia / analgesia • humane endpoint and method of euthanasia Workshop on Alternative Methods (3 R's) to Animal Tests

18. per experiment info on: personnel involved animals (species, number) housing conditions detailed protocol (data, volumes, routes, etc.) and specification of expected effects anaesthesia / analgesia description of discomfort description of agreements on: responsibilities (who does what and when) communication lines humane endpoint method of killing carcas treatment and post mortem investigation Protocol- conducting animal experiment 2. Detailed (working) protocol Workshop on Alternative Methods (3 R's) to Animal Tests

19. Protocol- conducting animal experiment 3. Welfare monitoring • daily records in direct neighbourhood of the animals • specification of relevant welfare (discomfort) parameters to be assessed (clinical signs, appearance, body weight, ..) • specification of relevant assessment time points • Assessment per group / individual • 4.Make an evaluation after the experiment has been finished! •  legal registration: purpose, number of animals, degree of discomfort, anaesthesia, analgesia, etc. Workshop on Alternative Methods (3 R's) to Animal Tests

20. Role of awo in education course FELASA Cat. C - scientist Legal requirements to design and conduct an animal experiment: • 500 study hours in biological disciplines (anatomy, physiology, etc.) • Basic course of 80 h in laboratory animal science • master in a biomedical discipline (e.g. Biology, Medicine, Pharmacology, Veterinary Medicine) Workshop on Alternative Methods (3 R's) to Animal Tests

21. Role of awo in education course FELASA Cat. C - scientist Curriculum of 80 h course: • biology and husbandry of laboratory animals • microbiology and disease • health hazards and safe practices in the animal facility • design and conduct of animal experiments • anaesthesia, analgesia and experimental procedures • alternatives to animal use • ethical aspects and legislation • analysis of scientific article (animal experiments) Workshop on Alternative Methods (3 R's) to Animal Tests

22. FELASA C courses at Utrecht University Division of Laboratory Animal Science, Faculty of Veterinary Medicine organizes annually: •  10 courses in Dutch language • 4 courses in English • 2 courses for foreigners working in the Netherlands • 2 courses for foreigners just attending the course (each course has 20-25 attendants) Workshop on Alternative Methods (3 R's) to Animal Tests

23. Offspin from international courses at Utrecht University Assistance in organizing and teaching in LAS training programs in foreign countries: Belgium proposals from: Brazil Greece Slovenia Hungary Thailand Latvia Turkey Portugal S-Africa Workshop on Alternative Methods (3 R's) to Animal Tests

24. Aim: Standardisation and 3 R’s Genetic quality/ definition (e.g. inbred) Microbiological (SPF) Housing (standard dimensions; enrichment; group/ individual) Care Techniques Tools: QA-system (ISO:9001, GLP, AAALAC) QA book (description procedures) SOP’s (standard procedures) Experimental protocol Daily welfare record Evaluation welfare record SummaryGuideline in advise and education Workshop on Alternative Methods (3 R's) to Animal Tests

25. SummaryGuideline in advise and education •  QC = Quality Control, 3 R’s • Results of animal experiments should be • Verifiable • Reproducable • Increase quality of animal experiments • Enhance welfare of animals Workshop on Alternative Methods (3 R's) to Animal Tests

26. Dilemma advisor < - > police officer • Relation with AEC • Relation with License holder, PR • Relation with (external) inspector • Relation with scientists, animal caretakers, etc. Workshop on Alternative Methods (3 R's) to Animal Tests

27. Current developments in NL • Public accountability – politics • Improvement position of awo independant, professional, transparant • Permanent education of awo (symposia, professional association) •  professionalization •  handbook (guideline) awo •  accreditation (education, performance) Workshop on Alternative Methods (3 R's) to Animal Tests

28. How to improve functioning of the awo • Describe tasks and responsibilities of awo • Describe training program for awo • Describe instructions and procedures for persons involved in animal experiments (Quality system – handbook) • Design and implement a central database (computerization) • Diminish bureaucracy (;-) Workshop on Alternative Methods (3 R's) to Animal Tests

29. Tesekkurler!Thanks for your attention! Fred Poelma Workshop on Alternative Methods (3 R's) to Animal Tests