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Animal Welfare Act (Act No. Xxv Of 2001) Animal Experimentation Regulations, 2003. (L.N. 263 Of 2003 )

ANIMAL WELFARE ACT (ACT NO. XXV OF 2001)Animal Experimentation Regulations, 2003IN exercise of the powers conferred by articles 32, 33 (2), 34, 35 (3) and (4), 36 (1), 37 (1), 40 (4), 42 (1) of the Animal Welfare Act, the Minister for Rural Affairs and the Environment has made the following regulations:-Title and scope.

2003.

(2) These regulations apply to any animals used or intended for use in any such experimentation or other scientific procedure where that procedure may cause pain, suffering, distress or lasting harm. It does not apply to any non-experimental agricultural or clinical veterinary practice.

(3) The scope of these regulations is to implement the provisions found under

European Union Council Directive 86/609/EEC.

(b) “Breeding establishment” means any establishment, from which animals are supplied with a view to their use in procedures.

(c) “Competent person” means any person who is considered by the Minister responsible for the Veterinary Services to be competent to perform the relevant function described in these regulations.

(d) “Establishment” means any stable or mobile facility, any building, group of buildings or other premises, including a place which is not wholly enclosed or covered.

(e) “Humane method of killing” means the killing of an animal with a minimum of mental and physical suffering appropriate to the species.

(f) “Intended for use” means bred or kept for the purpose of sale, disposal or use in any experimental or other scientific procedure.

(g) “Procedure” means any experimental or other scientific use of an animal which may cause it pain, suffering, distress or lasting harm, including any course of action intended to, or liable to, result in the birth of an animal in any such conditions, but excluding the least painful methods accepted in modern practice (ie. Humane methods) of killing or marking an animal.

A procedure starts when an animal is first prepared for use and ends when no further observations are made for that procedure, the elimination of pain, suffering, distress or lasting harm by the successful use of anaesthesia or analgesia or other methods does not place the use of an animal outside the scope of this definition.

(h) “Responsible Authority” means the Minister responsible for the Veterinary

Services .

(i) “Supplying establishment” means any establishment, other than a breeding establishment, from which animals are supplied with a view to their use in procedures.

(j) “User Establishment” means any establishment where animals are used in procedures.

(a)

(i) Avoidance or prevention of disease, ill-health or other abnormality, or

their effects, in man, vertebrate or invertebrate animals or plants, including the production and the quality, efficacy and safety testing of drugs, substances or products.

(ii) Diagnosis or treatment of disease, ill-health or other abnormality, or their effects, in man, vertebrate or invertebrate animals or plants.

(b) Detection assessment, regulation or modification of physiological conditions in man, vertebrate or invertebrate animals or plants.

animal.

(c) Protection of the environment in the interests of the health or welfare of man or

(d) Scientific research

(e) Forensic enquires.

(2) The environmental conditions in which animals are bred, kept or used shall be checked daily.

(3) The well-being and state of health of animals shall be observed sufficient closely and frequently to prevent pain or avoidable suffering, distress or lasting harm.

(4) Arrangements are made to ensure that any defect or suffering discovered is eliminated as quickly as possible.

(a) The pain caused by the procedure is less than the impairment of the animal’s well- being caused by the use of the anaesthesia or analgesia, or

(b) The use of anaesthesia or analgesia is incompatible with the aim of the procedure.

(2) The decision referred to in sub-regulation (1) of this regulation shall be taken by a competent person, in particular a veterinarian, or the person who, in accordance with regulation 2, is responsible for, or has performed, this procedure.

(3) Where, at the end of the procedure -

(a) an animal is to be kept alive, it shall receive the care appropriate to its state of health, be placed under the supervision of a veterinarian or other competent person and kept under conditions conforming to the requirements of regulation

4. The conditions laid down in this paragraph may, however, be waived where, in the opinion of a veterinarian, the animal would not suffer as a consequence of such exemption;

(b) an animal is not to be kept alive or cannot benefit from the provisions of regulation 4 for its well-being, it shall be killed by a humane method as soon as possible.

(4) No animal which has been used in a procedure entailing severe or enduring pain or suffering, irrespective of whether anaesthesia or analgesia was employed, shall be used in a further procedure unless it has returned to good health and well- being and either -

(a) The further procedure is one in which the animal is subject throughout to general anaesthesia which is to be maintained until the animal is killed, or

(b) The further procedure will involve minor interventions only.

(5) An animal shall not be used more than once in experiments entailing severe pain, distress or equivalent suffering.

(2) Arrangements shall be made at registered supplying establishments to record the number and species of such animals entering and leaving, the dates of these movements, from whom the animals concerned were acquired and the name and address of the recipient.

(3) The Veterinary Services shall prescribe the records which are to be kept and made available to it by the person in charge of the establishments mentioned in sub- regulation (1) and (2) of this regulation. Such records shall be kept for a minimum of three years from the date of the last entry.

Veterinary Services and shall comply with the conditions laid down in regulation 4.

(a) The person or persons who are administratively responsible for the care of the animals and the functioning of the equipment shall be identified;

(b) Sufficient trained staff shall be provided;

(c) Adequate arrangements shall be made for the provision of veterinary advice and treatment;

(d) A Veterinarian or other competent person should be charged with advisory duties in relation to the well-being of the animals.

(2) Species of animals which are not present in the above mentioned list, excluding poultry and fish, shall not be utilised for experimentation purposes unless a special exemption has been obtained under arrangements to be determined by the Minister.

(2) Procedures within the scope of education, training, or further training for purposes other than those referred to in sub-regulation (1) above shall not be permitted.

(3) Procedures referred to in sub-regulation (1) of this regulation shall be restricted to those absolutely necessary for the purpose of the education or training concerned and be permitted only if their objective cannot be achieved by comparably effective audio-visual or any other suitable methods.

(2) Information shall be collected in respect of -

24. (1) Subject to the provisions of these regulations and of the Animal Welfare Act, a person who infringes any of the provisions arising from these regulations, shall, on conviction, be liable to a fine (multa) of not less than Lm10, 000.

(2) Without prejudice to the provisions of sub-regulation (1) of this regulation, the Court may also order any person who is found guilty of committing an offence under these regulations, to pay for the expenses incurred by the Veterinary Services as a result of the said offence, the revocation of the permit issued under these regulations and the confiscation, retention and disposal of the corpus delicti.

a. “Cage” means a permanently fixed or movable container that is closed by solid walls and, at least on one side, by bars or meshed wire or, where appropriate, nets and in which one or more animals are kept or transported; depending on the stocking density and the size of the container, the freedom of movement of the animals is relatively restricted;

b. “Holding rooms” means rooms where animals are normally housed, either for breeding and stocking or during the conduct of a procedure.

c. “Pen” means an area enclosed, for example, by walls, bars or meshed wire in which on or more animals are kept; depending on the size of the enclosure and the stocking density, the freedom of movement of the animals is usually less restricted than in a cage;

d. “Run” means an area enclosed, for example, by fences, walls, bars, or meshed wire and frequently situated outside permanently fixed buildings in which animals are kept in cages or pens can move freely during certain periods of time in accordance with their ethological and physiological needs, such as exercise;

e. “Stall” means a small enclosure with three sides, usually a free-rack and lateral separations, where one or two animals may be kept tethered.

1. The Physical Facilities

1.1 Functions and general Design

1.1.1 Any facility should be so constructed as to provide a suitable environment for the species housed. It should also be designed to prevent access by unauthorised persons.

Facilities that are part of a larger building complex should also be protected by proper building measures and arrangements that limit the number of entrances and prevent unauthorised traffic.

1.1.2 It is recommended that there should be a maintenance programme for the facilities in order to prevent any defect of equipment.

1.2 Holding rooms

1.2.1 All necessary measures should be taken to ensure regular and efficient cleaning of the rooms and the maintenance of a satisfactory hygienic standard. Ceilings and walls should be damage-resistant with a smooth, impervious and easily washable surface. Special attention should be paid to junctions with doors, ducts, pipes and cables. Doors and windows, if any, should be impervious and have a non-slippery, easily washable surface which can carry the weight of racks and other heavy equipment without being damaged. Drains, if any, should be adequately covered and fitted with a barrier which will prevent animals from gaining access.

1.2.2 Rooms where the animals are allowed to run freely should have walls and floors with a particular resistant surface material to stand up to the heavy wear and tear caused by the animals and the cleaning process. The material should not be detrimental to the health of the animals and be such that the animals cannot hurt themselves. Drains are desirable in such rooms. Additional protection should be given to any equipment or fixtures so that they may not be damaged by the animals or hurt the animals themselves. Where outdoor exercise areas are provided measures should be taken when appropriate to prevent access by the public and animals.

1.2.3 Rooms intended for the holding of farm animals should at least conform with the standards laid down for the protection of animals kept for farming purposes.

1.2.4 Care should be taken not to house together species which are incompatible.

1.2.5 Holding rooms should be provided with facilities for carrying out minor procedures and manipulations, where appropriate.

1.3 Laboratories and general and special purpose procedure rooms.

1.3.1 At breeding or supplying establishments suitable facilities for making consignments of animals ready for dispatch should be made available.

1.3.2 All establishments should also have available as a minimum laboratory facilities for the carrying out of simple diagnostic tests, post-mortem examinations, and/ or the collection of samples which are to be subjected to more extensive laboratory elsewhere.

1.3.3 Provision should be made for the receipt of animals in such a way that incoming animals do not put at risk animals already present in the facility, for example by quarantining. General and special purpose procedure rooms should be made available for situations where it is undesirable to carry out the procedures or observations in the holding room.

1.3.4 There should be appropriate accommodation for enabling animals which are ill or injured to be housed separately.

1.3.5 Where appropriate, there should be provision for one or more separate rooms suitably equipped for the performance of surgical procedures under aseptic conditions. There should be facilities for post-operative recovery where this is warranted.

1.4.1 Store rooms for food should be cool and dry, vermin and insect proof and those for bedding , dry, vermin and insect proof. Other materials, which may be contaminated or present a hazard, should be stored separately.

1.4.2 Store rooms for clean cages, instruments and other equipment should be available.

1.4.3 The cleaning and washing room should be large enough to accommodate the installations necessary to accommodate the installations necessary to decontaminate and clean used equipment. The cleaning process should be arranged so as to separate the flow of clean and dirty equipment to prevent the contamination of newly cleaned equipment. Walls and floors should be covered with a suitably resistant surface material and ventilation system should have ample capacity to carry away the excess heat and humidity.

1.4.4 Provisions should be made for the hygienic storage and disposal of carcasses and animal waste. If incineration on the site is not possible or desirable, suitable arrangements should be made for the safe disposal of such material having regard to local legislation.

1.4.5 The design and construction of circulation areas should correspond to the standards of the holding rooms. The corridors should be wide enough to allow, easy circulation of movable equipment.

2. The environment in the holding room and its control.

2.1 Ventilation

2.1.1 Holding rooms should have an adequate ventilation system which should satisfy the requirements of the species housed. The purpose of the ventilation system is to provide fresh air and to keep down the level of odours, noxious gases, dust and infectious agents of any kind. It also provides for the excess heat and humidity.

2.1.2 The air in the room should be renewed at frequent intervals. A ventilation rate of 15-20 air changes per hour is normally adequate. However, in some circumstances, were stocking density is low, 8-10 air changes per hour may suffice or mechanical ventilation may not even be need at all. Other circumstances may necessitate a much higher rate of air change. Recirculation of untreated air should be avoided. However, it should be emphasised that even the most efficient system cannot compensate for poor cleaning routines and negligence.

2.1.3 The ventilation should be so designed as to avoid harmful draughts.

2.1.4 Smoking in rooms where there are animals shall be forbidden.

2.2 Temperature

2.2.1 Table 1 gives the range within which it is recommended that the temperature shall be maintained. It should also be emphasised that the figures apply only to adult, normal animals. New born and young animals will often require a much higher temperature level. The temperature of the premises should be regulated according to possible changes in the animals’ thermal regulation which may be due to special physiological conditions or to the effects of the procedures.

2.2.2 Under the climatic conditions in the territory of Malta it may be necessary to provide a ventilation system having the capacity to cool the air supplied.

2.2.3 In user establishments a precise temperature control in the holding rooms may be required, because the environmental temperature is a physical factor which has a profound effect on the metabolism of all animals.

2.3 Humidity

Extreme variations in relative humidity (RH) have an adverse effect on the health and well-being of animals. The RH level in holding rooms should be appropriate to the species concerned and should ordinarily be maintained at 55% +/- 10%. Values below 40% and above 70% RH for prolonged periods shall be avoided.

2.4 Lighting

In windowless rooms, it is necessary to provide controlled lighting both to satisfy the biological requirements of the animals and to provide a satisfactory working environment. It is also necessary to have a control of the intensity and of the light-dark cycle. When keeping albino animals, one should also take into account their sensitivity to light.

2.5 Noise

Noise can be an important disturbing factor in the animal quarters. Holding rooms and procedure rooms should be insulated against loud noise sources in the audible and in the higher frequencies in order to avoid disturbances in the behaviour and physiology of the animals. Sudden noises may lead to considerable change in organ functions but, as they are often unavoidable, it is sometimes advisable to provide holding and procedure rooms with a continuous sound of moderate intensity.

2.6 Alarm systems

A facility housing a large number of animals is vulnerable. It is therefore recommended that the facility is duly protected by the installation of devices to detect fires and the intrusion of unauthorised persons. Technical defects or a breakdown of the ventilation system is another hazard which could cause distress and even the death of animals, due to suffocation and overheating or, in less serious cases, have such negative effects on a procedure that it will be a failure and have to be repeated. Adequate monitoring devices should therefore be installed in connection with the heating and ventilation plant to enable the staff to supervise its operation in general. If warranted, a stand by generator should be provided for the maintenance of life support systems for the animals and lighting in the event of a break down or the withdrawal of supply. Clear instructions on emergency procedures should be prominently displayed. Alarms for fish tanks are recommended in case of failure of the
water supply. Care should be taken to ensure that the operation of an alarm causes as little disturbance as possible to the animals.

3. Care

3.1 Health

3.1.1 The person in charge of the establishment should ensure regular inspection of the animals and supervision of the accommodation and care by a veterinarian or other competent person.

3.1.2 According to the assessment of the potential hazard to the animals, appropriate attention should be paid to the health and hygiene of the staff.

3.2 Packing and transport conditions

All transportation is undoubtedly, for the animals, a stressful experience. The same regulations on transportation apply to animals for experimentation. Every precaution should be taken by sender and carrier in packing, stowing and transit to avoid unnecessary suffering through inadequate ventilation, exposure to extreme temperatures,
lack of feed and water, long delays, etc. The receiver should be properly informed about the transport details and documentary particulars to ensure quick handling and reception in the place of arrival.

The consignments of animals should be received and unpacked without avoidable delay. After inspection, the animals should be transferred to clean cages or pens and be supplied with feed and water as appropriate. Animals which are sick or otherwise out of condition should be kept under close observation and separately from other animals. They should be examined by a veterinarian or other competent person as soon as possible and, where necessary, treated. Animals which do not have any chance to recover should be killed at once by a humane method. Finally, all animals received must be registered according with the provisions of regulations 13 and 19 of these regulations. Transport boxes should be destroyed immediately if proper decontamination is impossible.

3.4 Quarantine, isolation and acclimatisation.

3.4.1 The objects of quarantine are -

a. To protect other animals in the establishment;

b. To protect man against zoonotic infection;

c. To foster good scientific practice.

Unless the state of health of animals introduced into an establishment satisfactory, it is recommended that they should undergo a period of quarantine.
Animals may be used for procedures during the quarantine period as long as they have become acclimatised to their new environment and they present no significant risk to other animals or man.

Firstly, there is the system found in breeding, supplying and user establishments in the bio-medical field designed to accommodate animals such as rodents, rabbits, birds, sometimes also ruminants, swine and horses. Suggested guidelines for cages, pens, runs and stalls suitable for such facilities are presented in Tables 3 to 6.
Secondly, there is the system frequently found in establishments conducting procedures only on farm or similar large animals. The facilities in such establishments should not be less than those required by current veterinary
standards.

All feed hoppers, troughs or other utensils used for feeding should be regularly cleaned and if necessary sterilised. If moist feed is used or if the feed is easily contaminated with water, urine, etc., daily cleaning is necessary.

3.7.4 Water received from public waterworks contain some micro-organisms which are usually considered to be harmless unless one is dealing with microbiologically defined animals. In such cases, the water should be

treated. Water supplied by public waterworks is usually chlorinated to reduce the growth of micro-organisms. Such chlorination is not always enough to keep down the growth of certain potential pathogens, as for example Pseudomonas. As an additional measure, the level of chlorine in the water could be increased or the water could be acidified to achieve the desired effect.

3.8 Bedding

Bedding should be dry, absorbent, non- dusty, non- toxic and free from infectious agents or vermin, or any other form of, contamination. Special care should be taken to avoid using sawdust or bedding material derived from wood which has been treated chemically. Certain industrial by-products or waste, such as shredded paper may be used.

3.9 Exercising and handling

3.9.1 It is advisable to take every possible opportunity to let animals take exercise.

3.9.2 The performance of an animal during a procedure depends very much on its confidence in man, something which has to be developed. The confidence once established should however be preserved. It is therefore recommended that frequent contact should be maintained so that the animals become familiar with human presence and activity. The staff should be sympathetic, gentle and firm when associating with animals.

3.10 Cleaning

3.10.1 The standard of a facility depends very much on good hygiene. Clear instructions should be given for the changing of bedding in cages and pens.

3.11 Humane killing of animals

3.11.1 All humane methods of killing animals require expertise which can be only attained by appropriate training.

3.11.2 A deeply unconscious animal can be exsanguinated but drugs which paralyse muscles before unconsciousness occurs, those with curarifom effects and electrocution without passage of current through the brain, should not be used without prior anaesthesia.

3.11.3 Carcass disposal should not be allowed before rigor mortis occurs.