The Irish Laboratory Animal Science Association (ILASA) is a central professional body whose members comprise senior academics,  managers of animal research facilities, Named Day-to-Day Care persons and other animal care staff, Named Veterinary Surgeons, licensed researchers and Research Ethics Committee members.  We represent the interests of constituent institutes (Charles River Laboratories - Ballina, Dublin City University, National University of Ireland Galway,  National University of Ireland Maynooth, Royal College of Surgeons in Ireland, University College Cork, University College Dublin and Trinity College Dublin) with regard to the implementation of the 3Rs in animal research, the sharing of knowledge and expertise to ensure the highest standards of animal welfare, the orderly running of registered animal research premises and liaison with the competent authority to ensure that legislative measures are in the best interests of the animals under our care and can be practically implemented.

The importance of Biomedical Research in Ireland and its potential for expansion in the future have been highlighted in the National Development Plan. To facilitate this expansion is imperative that we adapt to accommodate the changing needs of the research community.  We also need to provide public reassurance that legislative controls are effectively implemented to ensure optimum standards of care and welfare for experimental animals.  ILASA members have worked hard to ensure that their constituent institutes implement best practice standards for the care and welfare of experimental animals but have been both concerned and frustrated that legislative regulation has failed to reflect or support these advances. 

The impending revision of 86/609/EEC is likely to impose an additional layer of legislative requirements. It is essential that Part 7 of the proposed Animal Health and Welfare Bill includes enabling provisions to ensure appropriate ratification and implementation of the revised Directive.  For the reasons outlined below ILASA also advocates that Part 7 include provision for transfer of control and regulatory responsibilities for experimental animals to the Department of Agriculture, Fisheries and Food in addition to welfare responsibilities. 

ILASA welcomes the proposal for the drafting of a modern and comprehensive Animal Health and Welfare Bill and in particular the proposed consolidation of a wide range of existing legislation and replacement of outdated legislation.  However we are disappointed to note that the 1876 Cruelty to Animals Act (CAA), which incorporates SI566/2002, implementing EU Directive 86/609/EEC, is not included within this list of legislation and we are concerned that control and regulatory responsibilities for experimental animals will be exercised by the Department of Health & Children (DOHC) while welfare responsibilities will be assigned to the Department of Agriculture, Fisheries and Food (DAFF).   Based on our experience to date of an ad-hoc arrangement between DOHC and DAFF in administration of the 1876 Act we feel that this arrangement will be detrimental to needs of Ireland’s research community and to the welfare of experimental animals. 

Current requirements for licensing under the CAA amount to little more than a bureaucratic exercise, offering little in the way of protection for experimental animals and causing significant delays to execution of scientific research.  The regulatory burden could be greatly reduced and the objectives of the legislation more effectively realised by making use of established institutional ethical review processes.  In fact such a proposal is a substantial component of the draft revised EU Directive.  In order to effectively implement such a proposal a change in the current licensing system is required whereby the focus is on licensing of protocols rather than persons.  This issue has been repeatedly raised by ILASA members with the DOHC but to no avail.  We feel that DAFF, whose personnel are already familiar with the issues associated with the implementation of animal welfare regulations are in a far better position that DOHC to understand the issues and effectively undertake control and regulatory responsibilities for the welfare of experimental animals.

Another key objective of current legislation is to ensure that all those involved in the care and use of experimental animals have received appropriate training and education.  ILASA members have endeavoured to ensure that adequate training is provided and several of its founding members have provided a training course to this end.  We had some initial support from the DOHC but this has waned and although we have provided a platform at our training courses for introducing researchers to DOHC personnel and inspectors their participation has lapsed in recent years.  We feel that DAFF personnel could make a valuable contribution by participating in these training courses.  ILASA would also like to establish a forum for communication and discussions between DAFF inspectors, animal care staff and researchers. This could be used to facilitate notification /discussion of changes/proposed changes in legislation, licence application forms/procedures for licensing, appointment of inspectors, registration of premises etc.  Another suggestion is that DAFF inspectors would occasionally attend meetings of institutional animal research ethics committees to allow interaction with researchers and animal care staff and encourage harmonisation of operating procedures and protocol scrutiny.

SI 566/2002 requires all experiments on live vertebrate animals to be carried out in registered user establishments unless special exemption has been granted.  In the process of registration, premises must be inspected by an inspector appointed under the Act, to ensure compliance with legislative requirements.  The DOHC do not have appropriately trained staff to carry out these inspections and have in the past relied on an ad-hoc arrangement with DAFF veterinary personnel.  This has been an unsatisfactory arrangement from the points of view of both the inspectors and the research establishments and has led to delays in registration of establishments.  Furthermore there are no guidelines with respect to the duties and responsibilities of each category of named person on the registration document.  DOHC personnel, lacking appropriate training, appear reluctant to produce such guidelines.  The DAFF have staff who are trained in the care and welfare of animals and could produce such guidelines which would allow all named persons to discharge their duties, allowing a uniformity of approach to the care and welfare of experimental animals throughout the country

ILASA appreciates the opportunity for making a submission in relation to the draft Animal Health and Welfare Bill.   The majority of our members have many years experience in caring for experimental animals and advancing their welfare; we would welcome the opportunity to elaborate on the above issues and to engage further with DAFF to ensure that the draft Bill furthers the goal of optimising animal welfare
June 2008