Faculteit der Diergeneeskunde Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests Report of an animal welfare officer Fred Poelma, Ph.D. animal welfare officer Faculty of Veterinary Medicine Utrecht University, The Netherlands

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests 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.

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests 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, …)

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests 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.

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests 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.

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests Some key figures in the Netherlands 16 million people 81 license holders (institutions) 35 animal welfare officers (FELASA D) 25 Animal Ethics Committees animal experiments in laboratory animals in 2006  (European registration, not included re-use and animals just killed)

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests Purposes Animal Experiments in NL Science ,6% Drugs (medicines) ,9% Toxicity ,5% Education ,5% Diagnostics ,5% Other 36 Totally % Source: zo doende 2006 (

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests Laboratory animals used in NL in 2006 Mice 47% Rats 23% Chickens 18% Fish 3% Monkeys 0,1%

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests 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

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests 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]

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests Key figures 2006 UU and UMCU 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 behaviourVeterinary medicine  Infection and immunologyMedicine  Surgery, orthopedicsBiology  Endocrinology, cardiology, Pharmacology  anaesthesia, imaging techniques

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests 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

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests 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

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests 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

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests  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 experiment 1. Ethics committee application form Part A (background information)

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests 1. Ethics committee application form Part B (animals)  species (strain)  number  housing conditions (mandatory in EU: group / solitairy cage 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)

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests 1. Ethics committee application form Part C (animal experiment)  concise protocol  description experimental design  estimation of level and description of discomfort per treatment / procedure  duration of discomfort  description of anaesthesia / analgesia  arguments for not using anaesthesia / analgesia  humane endpoint and method of euthanasia

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests Protocol- conducting animal experiment 2. Detailed (working) protocol  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

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests 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.

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests 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)

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests 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)

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests 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 attendants)

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests Offspin from international courses at Utrecht University Assistance in organizing and teaching in LAS training programs in foreign countries: Belgiumproposals from: Brazil GreeceSlovenia HungaryThailand LatviaTurkey Portugal S-Africa

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests Summary Guideline in advise and education 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

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests Summary Guideline 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

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests Dilemma advisor police officer  Relation with AEC  Relation with License holder, PR  Relation with (external) inspector  Relation with scientists, animal caretakers, etc.

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests 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)

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests 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 (;-)

Ankara, November 2007 Workshop on Alternative Methods (3 R's) to Animal Tests Tesekkurler! Thanks for your attention! Fred Poelma