Animal Experimentation Regulations, 2003

L.N. 263 of 2003

ANIMAL WELFARE ACT

(ACT NO. XXV OF 2001)

Animal Experimentation Regulations, 2003

IN 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.

(1) The title of these regulations is the Animal Experimentation Regulations,

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.

Definitions.

Guidelines for accommodation and care of animals

Definitions

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.

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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 Service rooms

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.

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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

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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.

3.3 Reception and unpacking

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.

3.4.2 It is recommended that facilities should be set aside in which to isolate animals showing signs of or

suspected of ill-health and which might present a hazard to man or to other animals.

3.4.3 Even when the animals are seen to be in sound health it is good husbandry for them to undergo a period of

acclimatisation before being used a procedure. The time required depends on several factors, such as the stress to

which the animals have been subjected which in turn depends on several factors such as the duration of the

transportation and the age of the animal. This time shall be decided by a competent person.

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3.5 Caging.

3.5.1 It is possible to make a distinction between two broad systems of housing animals.

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.

3.5.2 Cages and pens should not be made out of material that is detrimental to the health of the animals, and their

design should be such that the animals cannot injure themselves and, unless they are disposable, they should be

made from a resistant material adapted to cleaning and decontamination techniques. In particular attention should

be given to the design of cage and pen floors which should vary according to the species and age of the animals

and be designed to facilitate the removal of excreta.

3.5.3 Pens should be designed for the well-being of the species. They should permit the satisfaction of certain

ethological needs (for example, the need to climb, hide or shelter temporarily) and be designed or efficient

cleaning and freedom from contact with other animals.

3.6 Feeding

3.6.1 In the selection, production and preparation of feed, precautions should be taken to avoid chemical,

physical and microbiological contamination. The feed should be packed in tight, closed bags, stamped with the

production date when appropriate. Packing, transport and storing should also be such as to avoid contamination,

deterioration or destruction. Store rooms should be cool, dark, dry and vermin and insect proof. Quickly

perishable feed like greens, vegetables fruit, meat, fish etc., should be stored in cold rooms, refrigerators or

freezers.

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.

3.6.2 The feed distribution process may vary according to the species but it should be such as to satisfy the

physiological needs of the animal. Provision should be made for each animal to have access to the feed.

3.7

Water

3.7.1 Uncontaminated drinking water should be always available to all animals. During transport it is acceptable

to provide water as part of a moist diet. Water is however a vehicle of micro-organisms and the supply should

therefore be so arranged that the hazard involved is minimised. Two methods are in common use, bottles and

automatic systems.

3.7.2 Bottles are often used with small animals like rodents and rabbits. When bottles are used, they should be

made from translucent material in order to enable their contents to be monitored. The design should be wide-

mouthed for easy and efficient cleaning and, if plastic material is used, it should not be reachable. Caps, stoppers

and pipes should also be sterile and easy to clean. All bottles and accessories should be taken to pieces, cleaned

and sterilised at appropriate and regular periods. It is preferable that bottles should be replaced by clean,

sterilised ones rather than be refilled in the holding rooms.

3.7.3 Automatic drinking systems should be regularly checked, serviced and flushed to avoid accidents and the

spread of infections. If solid-bottom cages are used, care should be taken to minimise the risk of flooding.

Regular bacteriological testing of the system is also necessary to monitor the quality of the water.

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

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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.

3.7.5 In fishes, amphibians and reptiles, tolerance for acidity, chlorine and many other chemicals differs widely

from species to species. Therefore provision should be made to adapt the water supply for aquariums and tanks to

the needs and tolerance limits of the individual species.

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.

3.10.2 Adequate routines for the cleaning, washing, decontamination and, when necessary, sterilisation of cages

and accessories, bottles and other equipment should be established. A very high standard of cleanliness and order

should also be maintained in holding, washing and storage rooms.

3.10.3 There should be regular cleaning and, where appropriate, renewal of the material forming the ground

surface in outdoor pens, cages and runs to avoid them becoming a source of infection and parasite infestation.

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.

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Table 1 : Guidelines for room temperatures

Species or groups of species

Optimal

temp

in

Centigrade

Mouse

20-24

Rat

20-24

Syrian Hamster

20-24

Gerbil

20-24

Poultry

15-21

Rabbit

15-21

Pigeon

15-21

Quail

20-24

Guinea pig

20-24

Table 2: Guidelines for local quarantine periods

Species

Days

Mouse

5-15

Rat

5-15

Gerbil

5-15

Guinea pig

5-15

Rabbit

20-30

Syrian Hamster

5-15

Table 3: Guidelines for caging small rodents and rabbits

Species

Minimum

Minimum cage height

cage floor

cm

area cm2

Mouse

Rat

Syrian Hamster

Guinea pig

Rabbit 1kg

Rabbit 2kg

Rabbit 3kg

Rabbit 4kg

Rabbit 5kg

Table 4: Guidelines for caging small rodents in breeding

Species

Minimum cage

Minimum

cage

floor area for

height cm

mother

and

litter cm2

Mouse

Rat

Syrian hamster

Guinea pig

Guinea pigs in harems

1000 per adult

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Table 5 : Guidelines for caging breeding rabbits

Weight

of

Minimum

Minimum

Minimum

Doe

cage

floor

cage height

nest

box

area per doe

floor

and litter

m2

cm

Kg

m2

0.30

0.1

0.35

0.1

0.40

0.1

0.45

0.1

0.50

0.1

Table 6 : Guidelines for caging birds

Species in weight

Minimum area

Minimum area for 2

Minimum area for 3 Minimum

Minimum

for one bird

birds

birds or more

cage

length of

height

trough per

g

cm2/bird

bird

cm2

cm2/bird

cm

cm

Chickens

100-300

300-600

600-1200

1200-1800

1800-2400

Adult

males

>2400

Quails

120-140

Mitbug] fl-Istamperija tal-Gvern — Printed at the Government Printing Press

(a) “Animal” unless otherwise qualified, means any live non-human vertebrate,

including free living and/or reproducing larval forms, but excluding other foetal or

embryonic forms.

(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.

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(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.

Procedure performance.

A procedure may be performed for one or more of the following purposes only

and subject to the restrictions laid down in these regulations.

(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.

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

animal.

(d) Scientific research

(e) Forensic enquires.

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General care and accommodation.

(1) Any animals used for use in a procedure shall be provided with

accommodation, and an environment with at least a minimum degree of freedom, food,

water and care, appropriate to the animals’ health and well-being. Any restriction on the

extent to which an animal can satisfy its physiological and ethological needs shall be limited

as far as practicable, in accordance with the provisions laid down under Schedule A.

(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.

Conduct of procedure.

A procedure shall not be performed for any of the purposes referred to in

regulation 2, if another scientifically satisfactory method, not entailing the use of an animal,

is reasonably and practically available.

Choice of species on performance of procedure.

When a procedure has to be performed, the choice of species shall be carefully

considered and, when required, be explained to the Minister responsible for the Veterinary

Services; in a choice between procedures, those should be selected which use the minimum

number of animals, cause the least pain, suffering, distress or lasting harm and which are

most likely to provide satisfactory results.

Elimination of pain, suffering, distress or lasting harm.

A procedure shall be performed under general or local anaesthesia or analgesia or

by other methods designed to eliminate as far as practicable pain, suffering, distress or

lasting harm applied throughout the procedure unless;

(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.

Declaration of painful procedure to the Veterinary Services.

Where it is planned to subject an animal to a procedure in which it will or may

experience severe pain which is likely to endure, that procedures must be declared and

justified to the Veterinary Services.

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Measures to be taken at the end of the procedure.

(1) At the end of the procedure it shall be decided whether the animal shall be

kept alive or killed by a humane method. An animal shall not be kept alive if, even though it

has been restored to normal health in all other respects, it is likely to remain in lasting pain

or distress.

(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.

Authorisation.

A procedure for the purpose referred to in regulation 3 may be carried out by

persons authorised, or under the direct responsibility of a person authorised. Authorisation

shall be granted only to persons deemed to be competent by the Veterinary Services.

Breeding or supplying establishments.

Breeding and supplying establishments shall be registered with the Veterinary

Services subject to the grant of an exemption under regulation 17 or regulation 18. Such

registered establishments shall comply with the requirements of regulation 4.

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Provisions to be found in the registration.

The registration provided for in regulation 11 shall specify the person in charge

of the establishment, who shall be competent to administer or arrange for suitable care for

animals of the species bred or kept in the establishment.

Arrangements to be made at registered breeding establishments.

(1) Arrangements shall be made at registered breeding establishments to record,

in respect of the animals bred there, the number and species of such animals leaving, the

dates they leave and the name and address of the recipient.

(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.

User establishments.

User establishments shall be registered with or otherwise approved by the

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

Installations and equipment.

Provisions shall be made at user establishments for installations and equipment

appropriate for the species of animals used and the performance of the procedures conducted

there. The design, construction and functioning of such installations and equipment shall be

such as to ensure that the procedures are performed as effectively as possible, with the object

of obtaining consistent results with the minimum number of animals and the minimum

degree of pain, suffering, distress or lasting harm.

Provisions for the persons at user establishments.

In user establishments -

(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.

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List of animals used in procedures.

(1) Animals of the species listed below which are for use in procedures shall be

acquired directly from or originate from registered breeding establishments, unless a general

or special exemption has been obtained under arrangements to be determined by the

Minister-

Mouse

Mus musculus

Rat

Rattus norvegicus

Guinea pig

Cavia porcellus

Golden Hamster

Mesocricetus auratus

Rabbit

Oryctolagus cuniculus

Quail

Coturnix coturnix

(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.

Procedures which may be conducted outside user establishments.

Procedures may, where authorised by the Veterinary Services, be conducted

outside user establishments.

Records.

Arrangements shall be made at user establishments to maintain records and

make them available as required by the Veterinary Services. In particular these records shall

be sufficient to meet the requirements of regulation 22 and, in addition, show the number

and species of all animals acquired, from whom they were acquired and their date of arrival.

Education and training.

(1) Procedures carried out for the purpose of education, training or further

training for professions or other occupations, including the care of animals being used or

intended for use in procedures, must be notified to the Veterinary Services and shall be

carried out by or under the supervision of a competent person, who will be responsible for

ensuring that the procedures comply with these regulations.

(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.

Who may take care of animals used in procedures.

Persons who carry out procedures, or take part in procedures, or take care of

animals used in procedures, including supervision, shall have had appropriate education and

training.

Statistical information.

(1) The Veterinary Services shall collect statistical information on the use of

animals in procedures and this information shall, where lawful, be made available to the

public.

(2) Information shall be collected in respect of -

(a) The numbers and kinds of animals used in procedures;

(b) The numbers of animals in selected categories used in procedures directly

concerned with medicine and in education and training;

(c) The numbers of animals in selected categories used in procedures for the

protection of man and the environment;

(d) The number of animals in selected categories used in procedures required by

law.

Recognition of procedures carried out in the territory of another party.

In order to avoid unnecessary repetition of procedures required by law on health

and safety, the Veterinary Services, where practicable, recognise the results of procedures

carried out in the territory of another party.

Penalty for non-fulfilment of obligations.

(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.

B