Role of the Named Day to Day Care Person L.A.S.T National Licensee Training Course 2007

1. Role of the Named Day to Day Care PersonL.A.S.T National Licensee Training Course 2007 Colin Travis FIAT R.AnTech Conway Institute Biotechnical Services

2. Role of the Named Day to Day Care Person :Topics • What is a Named Day to Day Care Person (or N.D.D.C.P ) • What does Day to Day Care mean • What can the N.D.D.C.P do for you and your animals • What can you do for the N.D.D.C.P

3. Relationship with UK Legislation • The LAST Ireland course is recognised in the UK as equating to Modules 1 to 3 of Home Office Licensee training ( Personal Licence ) • The title and duties of the N.D.D.C.P were adopted into Irish Law directly from the UKs 1986 Animals (Scientific Procedures) Act • In the UK the position has since been re-designated the Named Animal Care and Welfare Officer ( or N.A.C.W.O) • The term NACWO and other aspects of UK legislation may come up in your exam!

4. The short answer: A suitably qualified person, named on the premises of registration, as having responsibility for day to day care of the animals Unfortunately this short answer is short on definition Interpretations could be wide ranging! Leave behind any pre-conceptions of laboratory animal care based on other uses of animals in society What is a N.D.D.C.P “ It’s not dead, it’s resting “

5. What is a N.D.D.C.P EU Directive 86/609 and Registration of Premises • This Directive is the overarching EU legislation covering all use of animals in research. Its text is reproduced verbatim in S.I 566 2002, which updated the 1876 Cruelty to Animals Act in Ireland • The Directive requires registration of premises and identification of `responsible persons` as one condition of registration • Article 19 – User establishments shall be registered with, or approved by, the authority. In each user establishment the person or persons who are administratively responsible for the care of the animals and the functioning of the equipment shall be identified • Articles 15 - Breeding and supply establishments ..registration shall specify the competent person responsible for …appropriate care to the animals

6. What is a N.D.D.C.P The Directive lists several more conditions of registration UK legislation split the responsibility of meeting these requirements across 3 `Named Persons` in an arrangement which was subsequently incorporated into Irish legislation : The Named Veterinary Surgeon (NVS) The Named Administrator (or Certificate Holder) * And the Named Day to Day Care Person (or NACWO) • * Usually a senior University Administrator in a position to maintain compliance with regulations that have significant resource implications such as building repairs or recruitment to ensure “sufficient trained staff shall be provided” (Article 19.2.a )

7. What is a N.D.D.C.P • In the UK additional direction is provided in Home Office Guidance Documents and Codes of Practice. Guidance, as amended in 2000 and therefore applicable to the Named Persons at the time they were adopted into Irish regulation, includes the following: • 4.56 NACWOs should have expert knowledge and suitable experience of relevant animal technology. A suitable person might, for example, be a senior animal technician with an appropriate animal technology qualification, or an experienced stockman with an appropriate qualification in agricultural science • 4.8 NACWOs should have an up-to-date knowledge of laboratory animal technology; be aware of the standards of care, accommodation, husbandry and welfare set out in the relevant Codes of Practice • In the UK candidates must also now first pass a 2 day NACWO training course. This has not yet been stipulated in Irish regulation • The person who will assume the role of NDDCP will normally be the Manager of your Animal Facility

8. What does Day to Day Care mean • EU 609 sets out a number of general welfare principals in a series of Articles and detailed specifications of standards of care in an Annex Article 5 – (first 2 clauses only) • (a) all experimental animals shall be provided with housing, an environment, at least some freedom of movement, food, water and care which are appropriate to their health and well-being • (b) any restriction on the extent to which an experimental animal can satisfy its physiological and ethological (Behavioral) needs shall be limited to the absolute minimum • For the implementation of the provisions of paragraphs (a) and (b) Member States shall pay regard to the guidelines set out in Annex II.

9. What does Day to Day Care mean Annex II (Appendix A) Guidelines for accommodation and care of animals • The Annex uses the word Care 146 times, and includes a definition: • 5: …Its substance is the sum of material and non-material resources provided by man to obtain and maintain an animal in a physical and mental state where it suffers least, and promotes good science. It starts from the moment the animal is intended to be used in procedures, including breeding or keeping for that purpose and continues until it is humanely killed • Headings include : General Design, Ventilation, Temperature, Lighting, Noise, Health, Transportation, Housing, Bedding and Nesting, Environmental Enrichment, Identification, Feeding, Handling, Education and Training and Humane killing • These are giving as general principals and as species specific guides ranging from rodents to reptiles, pigs to primates

10. What does Day to Day Care mean Providing Care to study animals • Research procedures may impact an animals physical or mental state, are they therefore a part of the NDDCP’s areas of responsibility ? The UK Guidance includes the following statements • 3.9/10 NACWOs and Named Veterinary Surgeons … need to be entrusted with the necessary management authorities and their advice on the welfare of animals should be sought and taken by project and personal licence holders, of whatever seniority, both at the planning stage and whilst work is in progress. • 4.58 NACWOs should be familiar with the main provisions of the project licences, particularly the adverse effects expected for each protocol, and the control measures and the humane endpoints specified • 4.58 NACWOs should take an active part in the ethical review process at the establishment, and advise applicants for licences and licensees on practical opportunities to implement the replacement, reduction and refinement alternatives

11. What can the N.D.D.C.P do for you and your animals Help maintain compliance with regulations • The animals shall at all times be under the care and supervision of a competent person • Any restrictions on the extent to which an animalcan satisfy its physiologogical and ethological needs shall be limited to the absolute minimum • The well being and state of health of the animals shall be observed by a competent person to prevent pain or avoidable suffering, distress or lasting pain (this is probably meant to read lasting harm!) • The environmental conditions in which animals are bred or kept shall be checked daily • ALL THE ABOVE ARE CONDITIONS ISSUED WITH DOH RESEARCH LICENCES

12. What can the N.D.D.C.P do for you and your animals More importantly – Help achieve the two mutually beneficial objectives of regulation • Maintain an animal in a physical and mental state where it suffers least • Maximise reproducibility and reliability of study data • Not only are most aspects of care and welfare inter-related they will also effect how reproducible and reliable your animals are as research models More consistent animal models equals smaller group sizes, equals `Reduction` of animal use

13. What can the N.D.D.C.P do for you and your animals

14. What can the N.D.D.C.P do for you and your animals key areas of care The Macro-Environment – Rooms / enclosures To provide for all aspects of environment and to monitor and record daily, environmental conditions eg Rodents 20oc to 24oc. Humidity @ 45 to 65% (Gerbils 35 -55%) Rabbits 15oc to 21oc. Humidity not less than 45% Ringtail in a pre-weaner rat caused by low relative humidity Hygiene – disinfection, sterilisation Bio-security – ie Health Barriers General Security - against escape, or careless or deliberate interference with animals, equipment etc

15. What can the N.D.D.C.P do for you and your animals Micro-Environment – Cages, tanks, pens • Provide species appropriate bedding and nesting materials, free of infectious or contaminating agents (or water of correct temperature, pH etc, if fish or amphibians) • Ensure tanks/cages/pens are changed at a correct frequency • Maintaining routines, consistency of environment and staff, gentle handling etc contribute to reducing animal stressand, consequently, physiological variables • Carry out daily checks of all tank, cage or pen environments and all animals

16. What can the N.D.D.C.P do for you and your animals • To provide drinking water and diets free of infectious agents and contaminants and of correct nutrition and palatability • There are several specialised suppliers of GLP lab animal diets, each catering for a range of species including fish/dog/cat/farm animal and primate • Some species may have available a number of diet types eg rodent diets can be selected on the basis of % protein • Diets should be presented in an appropriate manner eg ad-lib / weight matched / group or individual feeding / suitable frequency

17. What can the N.D.D.C.P do for you and your animals • Monitor stocking densities against tank/cage/pen dimensions • Table G.1. Cattle: Minimum enclosure dimensions and space allowances • Table D.1. Dogs: Minimum enclosure dimensions and space allowances

18. What can the N.D.D.C.P do for you and your animals • Health checks Monitor animals for ill health including age related, phenotype related ( both wild type and GM ), con-specific aggression • In C57Bl/6J the rate of malocclusion is 25 times more than the Balb/cJ strain ( many Transgenic lines are on a C57 background! ) • The lifetime mammary tumour incidence in F344 rat can be 41% in females and 23% in males • Monitor for research associated adverse effects – both expected and unexpected. Record and score as appropriate and implement end points • With the NVS, to record and investigate all ill health and put into practice procedures to prevent and alleviate ill health

19. What can the N.D.D.C.P do for you and your animals Sourcing / Breeding animals • Source animals of appropriate health status Demonstrable SPF standard or suitable `clean up` • Advise on best supply strategies – eg breed in-house or source, buy time mated or lactating • Ensure suitable transport to the Facility • Maintain breeding colonies to produce animals as required for research with minimum surplus production

20. Providing environmental enrichment Annex II 4.4.1 ……. Pigs have a high motivation to explore and should be provided with an environment of sufficient complexity to allow expression of species specific exploratory behaviour. All pigs should at all times have access to adequate amounts of materials for investigation and manipulation, including rooting, in order to reduce the risk of behavioural disorders key areas in achieving those objectives Berdoy, M. 2002. The Laboratory Rat: A Natural HistoryU:\7ratrun.mpg

21. Providing environmental enrichment Improvements in rabbit housing key areas in achieving those objectives

22. Ear Biopsy. A routine part of maintaining many transgenic colonies. A refinement over tail biopsy key areas in achieving those objectives Training of Research staff and animal Technicians • To train and assist research staff in handling, procedure techniques, appropriate anaesthesia and analgesia regimes, and methods of euthanasia, and to perform certain in-vivo procedures on behalf of researchers Oral Gavage. Experience in restraint and dosing will reduce stress and incidence of trauma

23. What can you do for the NDDCP Communicate Before you start animal work What is the animal model; age, sex, precise strain etc what is the phenotype, particularly if Transgenic Where will they come from What is the research procedure, adverse effects, end points During your animal work Schedules, changes, observed effects And after your animal work Feed back what was successful and what was not Finally Let your NDDCO know when your paper is published in Nature!

24. Reference data • SI 566 2002 http://www.ucd.ie/biomed/pdf/legislation/1876-CAA-Regulations.PDF • EU Directive 86/606 http://europa.eu.int/eurlex/en/consleg/pdf/1986/en_1986L0609_do_001.pdf • Revised ANNEX II of 86/609 http://www.coe.int/T/E/Legal_affairs/Legal_co-operation/Biological_safety,_use_of_animals/Laboratory_animals/GT%20123%20(2004)%201%20Appendix%20A%20final%20for%20adoption%20DRAFT.pdf • UK Home Office Guidance to the 1986 (Animals (Scientific Procedures Act) http://www.archive.official-documents.co.uk/document/hoc/321/321.htm • UK Home Office Codes of Practice – Housing and Care http://scienceandresearch.homeoffice.gov.uk/animal-research/publications/publications/code-of-practice/