Good Practice Guide for the Use of Animals in Research, Testing and Teaching

September 2002

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Disclaimer

While every effort has been made to ensure the information in this guide is accurate, MAF and NAEAC, their employees and consultants expressly disclaim all and any liability to any person in respect of anything, and the consequences of anything, done or omitted to be done in reliance, whether wholly or partly, upon the whole or any part of the contents of this publication.

1. Introduction

8. Access to Further Information

Appendix I: Pain: some concepts and definitions

Appendix II: Animal technician courses

Appendix III: Animal welfare score sheet

Appendix IV: Animal welfare information center

1. Introduction

The welfare of animals in New Zealand is safeguarded by the Animal Welfare Act 1999, which requires those in charge of animals to take all reasonable steps to ensure the physical, health and behavioural needs of those animals, according to both good practice and scientific knowledge, further defining those needs as including:

proper and sufficient food and water
adequate shelter
opportunity to display normal patterns of behaviour
physical handling in a manner which minimises the likelihood of unreasonable or unnecessary pain or distress
protection from, and rapid diagnosis of, any significant injury or disease.

It is acknowledged, however, that the nature of the research, testing or teaching may mean that the general obligations under the Act cannot be met, thus recognising that compromised care and some pain or distress to a small number of animals may result in significant benefits to people, other animals or the environment. For this reason, such use of animals is governed by a self-standing set of provisions (Part 6) within the Animal Welfare Act 1999 - when animals are manipulated as part of an approved research, testing or teaching project, the rest of the Act does not apply.

The ethical and philosophical implications of the traditional ways animals have been used, particularly in research, testing and teaching, have come under increasing scrutiny. Both the public and the scientific community are concerned that standards of husbandry and care of animals in laboratories should at least parallel those required in other areas. It is for this reason that such use of animals carries with it significant responsibilities and strict legislative obligations. For instance, Part 6 of the Act allows such activities to be carried out only in cases where there is good reason to believe:

that the findings of the research or testing or the results of the teaching will enhance the understanding of human beings, animals, or ecosystems; the maintenance or protection of human or animal health or welfare; the management, protection, or control of ecosystems, plants, animals, or native fauna; the production and productivity of animals; or the achievement of educational objectives; and
that the benefits derived from the use of animals in research, testing, and teaching are not outweighed by the likely harm to the animals.

Institutions and investigators are referred to the Act itself, as well as to the MAF Policy Information Paper 33 (The Use of Animals in Research, Testing and Teaching: Users Guide to Part 6 of the Animal Welfare Act 1999) for information on legislative requirements including legal definitions, the preparation of codes of ethical conduct (CECs) and the formation of animal ethics committees (AECs).

Section 80(2)(a)(i) of the Animal Welfare Act 1999 states that one of the purposes of Part 6 of the Act is to ensure that, in relation to animals used in research, testing and teaching, all reasonable steps are taken to ensure that the physical, health and behavioural needs of those animals are met in accordance with both good practice and scientific knowledge.

This publication is intended to encourage those responsible for such animals to adopt the highest standard of husbandry and animal care. It is intended as a guide for people who are involved in the care and use of animals for the following scientific purposes which involve the manipulation of an animal:

investigative, experimental, diagnostic, toxicity, or potency testing work;
work carried out for the purpose of producing antisera or other biological agents; and
teaching.

2. Purpose of this Guide

2.1 Purpose

The purpose of this guide is to promote the humane and responsible use of animals for scientific purposes. Section 80(2)(a)(i) of the Animal Welfare Act 1999 states that one of the purposes of Part 6 of the Act is to ensure that, in relation to animals used in research, testing and teaching, all reasonable steps are taken to ensure that the physical, health and behavioural needs of those animals are met in accordance with both good practice and scientific knowledge. The aim of this publication is to set guidelines for what constitutes "good practice" in the management of animals in the research, testing and teaching environment. It is not intended to be an exhaustive guide, and contains a list of publications for reference purposes for more specific and detailed information.

2.2 Scope

The guide encompasses all aspects of the care and use of animals for scientific purposes in medicine, biology, agriculture, veterinary and other animal sciences, industry and teaching. It includes their use in research, teaching, field trials, and product testing.

The guide provides general principles for the care and use of animals, and specifies the responsibilities of investigators and teachers. It also provides guidelines for the humane conduct of experiments, and for the acquisition of animals and their care.

2.3 Background to the guide

This guide is adapted from the 1995 Animal Welfare Advisory Committee (AWAC) Code of Recommendations and Minimum Standards for the Care and Use of Animals for Scientific Purposes. This was in turn based on the 5th edition of the Code of Practice sponsored by the Australian National Health and Medical Research Council (NHMRC), the Australian Commonwealth Scientific and Industrial Research Organisation (CSIRO), and the Australian Agricultural Council (AAC).

The guide has been produced to accommodate changes in the legislation brought about by the introduction of the Animal Welfare Act 1999. The guide was developed by a representative working group established by the National Animal Ethics Advisory Committee (NAEAC) and has taken account of the further revision to the NHMRC Code of Practice in 1997 (6th edition).

The first Australian code was produced by the NHMRC in 1969. Revisions of the code were undertaken in conjunction with the CSIRO in 1979 and 1982, with the CSIRO and the AAC in 1985, and with CSIRO, ARMCANZ, ARC and AVCC in 1997. Periodic revisions reflect changes in biological science and in community attitudes.

2.4 Comments on the guide

Comments on this guide are invited and should be addressed to:

The Secretary
NAEAC
PO Box 2526
Wellington

2.5 Definitions of terms and abbreviations used in this guide

Analgesia: The temporary abolition or diminution of pain perception. Anaesthesia: A state of controllable, reversible insensibility in which sensor perception and motor responses are both markedly depressed. Animal: The Animal Welfare Act 1999 defines "animal" as;

Any live member of the animal kingdom that is;
1. A mammal; or
2. A bird; or
3. A reptile; or
4. An amphibian; or
5. A fish (bony or cartilaginous); or
6. Any octopus, squid, crab, lobster, or crayfish (including freshwater crayfish); or
7. Any other member of the animal kingdom which is declared from time to time by the Governor-General, by Order in Council, to be an animal for the purposes of this Act; and
Includes any mammalian foetus, or any avian or reptilian pre-hatched young, that is in the last half of its period of gestation or development; and
Includes any marsupial pouch young.

AEC: Animal Ethics Committee.

Approved project: A project which has been formally approved by a properly constituted AEC, on the basis of a written proposal.

Cachexia: Severe generalised weakness, malnutrition and emaciation.

CEC: Code of Ethical Conduct.

Distress: Acute or chronic response of an animal caused by stimuli that produce observable biological stress as shown by abnormal physiological or behavioural responses.

Embryonated egg: An egg in the last half of incubation.

Endangered species: A species named as endangered in the Wildlife Act 1953, the Trade in Endangered Species Act 1989, or any other Act of the Parliament, or in the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES).

ERMA: Environmental Risk Management Authority New Zealand.

Euthanasia: The humane termination of life.

Experiment: Any test or trial for a scientific purpose, including any activity to test an hypothesis or demonstrate a known fact.

Foetus: An unborn mammal in the last half of gestation.

GM: Genetically modified.

HSNO Act: Hazardous Substances and New Organisms Act 1996.

IATA: International Air Transport Association.

IBSC: Institutional Biological Safety Committee.

Investigator: A person approved by an AEC to be responsible for the conduct of an approved project involving animals.

Pain: An awareness of acute or chronic discomfort, occurring in varying degrees of severity, and resulting from injury, disease, or emotional distress as evidenced by biological or behavioural changes or both.

MAF: Ministry of Agriculture and Forestry.

Manipulation: The Animal Welfare Act 1999 defines "manipulation" in relation to any live animal as meaning interfering with the normal physiological, behavioural or anatomical integrity of the animal by deliberately

Subjecting it to a procedure which is unusual or abnormal when compared with that to which animals of that type would be subjected to under normal management or practice and which involves:
1. Exposing it to any parasite, micro-organism, drug, chemical, biological product, radiation, electrical stimulation, or environmental condition; or
2. Enforced activity, restraint, nutrition, or surgical intervention; or
Depriving it of usual care; but does not include:
1. Any therapy or prophylaxis necessary or desirable for the welfare of the animal; or
2. The killing of an animal as the end point of research testing or teaching if the animal is killed in such a manner that it does not suffer unreasonable or unnecessary pain or distress; or
3. The killing of an animal in order to undertake research, testing or teaching on the dead animal or on prenatal or developmental tissue of the animal if the animal is killed in such a manner that it does not suffer unreasonable or unnecessary pain or distress.

Project: A series of related experiments that forms a discrete piece of research.

Proposal: A written outline of a research project put forward for consideration by an AEC.

Scientific purposes: All those activities performed to acquire, develop or demonstrate knowledge or techniques in any scientific discipline, including activities for the purposes of teaching, research, diagnosis, product testing, and the production of biological products.

Tranquillisers: Drugs which are used to treat anxiety or produce sedation.

Throughout this guide:

"shall" means that there is a statutory requirement;
"must" denotes a minimum standard;
"should" and "may" denotes a recommendation.

3. Acquisition of Animals

3.1 Animals collected from their natural habitats

Most species of indigenous fauna are protected by law. The Department of Conservation must be consulted when these species are required. Permits are usually necessary to collect, keep, release or kill protected fauna, and further permits are usually required to import or export such species. Any conditions imposed on permits must be observed.

An animal that is a member of an endangered species must not be used unless the research will be of direct benefit to the conservation of that species or a closely related species and will not further endanger the species.

Animals should be taken from natural habitats only if animals bred in captivity are not available or are unsuitable for the specific scientific purpose.

Capture and restraint is stressful to animals. Strategies must be employed to minimise distress during capture and disruption of the colonies from which they are taken. There must be careful choice of suitable capture techniques, skilled persons must be used, and appropriate and safe enclosures or caging must be provided after capture. Animals must be monitored for signs of distress following capture and appropriate measures taken to minimise the stress and treat any capture-induced trauma.

Fish may be caught using commercial harvesting practices.

The use of traps must conform to requirements of the Animal Welfare Act 1999 (section 36), which states that traps must be inspected within 12 hours after sunrise every day beginning on the day immediately after the day on which the trap was set, and any living animal removed. Trapped animals should be protected from predators and environmental extremes, and food and water must be provided as necessary.

3.2 Animals obtained from other countries

Under the Biosecurity Act 1993, New Zealand can restrict the exit and entry of animals or animal tissues.

Permits must be obtained from MAF for the importation of live animals, and their genetic material.

When genetically modified animals are to be imported, the IBSC must be consulted and approvals obtained from ERMA through the institutional committee. The housing and use of GM organisms and animals requires specialised transitional and containment facilities for vertebrate laboratory animals. MAF approval must first be obtained for the establishment of transitional/containment facilities. This approval requires an on-site inspection by MAF supervisors.

Permits must be obtained from MAF for the importation of dead animal specimens.

Permits must be obtained from the Department of Conservation for the import/export of both live and dead specimens of all native New Zealand fauna and animals or plants subject to the Trade in Endangered Species Act 1989 or regulations.

3.3 Transport of animals

The Animal Welfare Act 1999 (section 22) requires that the person in charge of any vehicle or aircraft, and the master, or where there is no master the person-in-charge, of every ship, shall ensure that the welfare of any animal conveyed therein is attended to, and that the animal is provided with reasonably comfortable and secure accommodation. The consignor is responsible for arranging for the supply of food and water en route.

Under section 23 of the Act, it is an offence to confine or transport an animal in a manner or position that causes the animal unreasonable or unnecessary pain or distress, or to transport it if its condition or health is such as to render it unfit to be transported.

Investigators are referred to the Code of Recommendations and Minimum Standards for the Transport of Animals Within New Zealand for further detailed requirements associated with transporting animals. Transport by air must be in accordance with IATA regulations.

Transportation can cause distress due to confinement, movement, noise and changes in the environment and personnel. The extent of any distress will depend on the animals' health, temperament, species, age, sex, the number travelling together and their social relationships, the period without food or water, the duration, the mode of transport, environmental conditions, particularly extremes of temperature, and the care given during the journey.

Animals must be transported under conditions which are appropriate to the species and which meet standards generally adopted in veterinary and laboratory animal medicine to ensure that the welfare of the animals is not unduly compromised. Potential sources of distress should be identified and steps taken to avoid or minimise their effects on the animals.

Containers must be escape and tamper proof, there should be adequate nesting or bedding material where appropriate and animals should be protected from sudden movements and extremes of climate.

Food and water should be provided when necessary.

Both the suppliers and recipients of animals must ensure that delivery procedures are satisfactory. Suppliers should notify recipients of transport details (i.e. flight number and estimated time of arrival) to ensure swift delivery. Recipients should ensure that animals are received by a responsible person and transferred to holding accommodation without delay.

The transfer of GM animals between approved institutional containment facilities requires approval from the regional MAF supervisor prior to shipment.

3.4 Admission of new animals into holding areas

When new animals are being admitted into animal holding areas, they should be quarantined and inspected by a qualified person. Their health should be evaluated, treatment instigated if required, and their suitability for the proposed experiments assessed. This period should also allow their acclimatisation to the holding facility and staff.

For importation of animals, the duration of quarantine varies. Animals must be housed physically separated from other animals and in general no experimental manipulations are permitted while animals are held in quarantine. However, animals may be bred while in quarantine.

Animals which do not adapt satisfactorily to their new environment should not be kept.

4. Facilities

4.1 General

Facilities include the buildings, yards or paddocks in which animals are kept.

Investigators, AECs and the institutions must ensure that facilities are appropriately staffed, designed, constructed, equipped and maintained to achieve a high standard of animal care and fulfil scientific requirements.

The design and management of facilities will depend on the type of animals to be kept and the experiments to be undertaken. The overall condition and management of facilities should permit effective maintenance and servicing and be compatible with maintaining the animals in good health.

4.2 Outdoor holding areas

These should be compatible with the needs of the species, provide adequate shelter and water, protect the animals from predation, meet other species-specific needs, and should comply with established farm or zoological garden practice.

4.3 Indoor housing

Buildings should be compatible with the needs of the animals to be housed, and the projects undertaken. Facilities for free movement and group contact are especially important for some species of animals.

Buildings should be designed and operated to control environmental factors appropriately, to exclude vermin and to limit contamination associated with the keeping of animals, the delivery of food, water and bedding, and the entry of people and other animals.

Buildings should be maintained in good repair. Walls and floors should be constructed of durable materials that can be cleaned and disinfected readily.

Buildings should be kept clean and tidy, and operated to achieve maximum possible hygiene. A pest control programme should be run to monitor and control vermin.

There should be adequate storage areas for food, bedding and equipment. Food should be stored in a way which minimises deterioration of nutritional value and palatability and prevents contamination by feral rodents and other pests.

Detergents, disinfectants and pesticides may contaminate the animal's environment and choice of agents should be made in consultation with investigators. Deodorants designed to mask animal odours should not be used in animal housing facilities. They should not substitute for appropriate cage and equipment cleaning practices, nor for adequate ventilation. Furthermore, they expose animals to volatile compounds which can alter metabolic processes.

Cleaning practices should be monitored on a regular basis to ensure effective sanitation; this can include visual inspection, monitoring water temperatures and microbiological testing of surfaces after cleaning.

There should be a reticulated water supply and proper facilities for drainage, if appropriate.

There should be adequate contingency plans to cover such emergencies as flooding and fire, or the breakdown of lighting, heating, cooling or ventilation.

In the interest of disease prevention and general animal welfare, access to the animal quarters by unauthorised persons should be avoided.

4.4 Environmental factors

Animals should be provided with environmental conditions which suit their behavioural and biological needs unless otherwise approved by the AEC for the purposes of a project.

Air exchange, temperature, humidity, noise, light intensity and light cycles should be maintained within limits compatible with the health and well-being of the animals.

Effective ventilation is essential for the comfort of animals and the control of temperature, humidity, and odours. Ventilation systems should distribute air uniformly and achieve adequate air exchange, both within cages and within a room.

Noxious odours, particularly ammonia, should be kept to a level compatible with the health and comfort of the animals and staff. The adequacy of the ventilation system, the design, construction and placement of cages and containers, population densities both within cages and within a room, the effectiveness of the cleaning and the frequency of bedding changes, will all influence the level of noxious gases. Attention should be given to the balance between the need for cleanliness and the potential impact of cleaning procedures on the animals.

These environmental factors potentially affect the welfare of the animals and may affect the results of experiments. Investigators should be informed in advance of planned changes to the environmental conditions of their animals.

4.5 Pens, cages and containers and the immediate environment of the animals

Pens, cages and containers should be designed, constructed and maintained to ensure the comfort and well-being of the animals, taking into account the following factors:

species-specific behavioural requirements, including free movement and activity, sleeping, privacy, and contact with others of the same species;
species-specific environmental requirements such as lighting, temperature, air quality, appropriate day/night cycles and protection from excessive noise and vibrations;
provision of single housing for animals when it is appropriate for the species and if necessary for the purpose of the experiment, e.g. during recovery from surgery or collection of samples;
the need to provide ready access to food and water;
the need to clean the pen, cage or container;
protection from spread of pests and disease;
requirements of the experiments; and
the need to observe the animals readily.

Pens, cages and containers should:

be constructed of durable, impervious materials;
be kept clean;
be maintained in good repair;
be escape-proof;
protect the animals from climatic extremes;
not cause injury to the animals;
be large enough to ensure the animals' well-being - animals should be able to stretch out when recumbent and to stand upright; and
be compatible with the behavioural needs of the species.

Wire floor cages for rodents should not be used unless essential to the research protocol and then only for brief periods. Animals should have a solid resting area when housed on wire floors.

The population density of animals within cages, pens or containers and the placement of these in rooms should be such that acceptable social and environmental conditions for the species can be maintained. Where it is necessary to individually house animals of a species which is normally kept in a social group, the conditions should be managed so as to minimise the impact of social isolation. Animals should be housed in these circumstances for the minimum time necessary.

Bedding and litter should be provided if appropriate to the species, and should be comfortable, absorbent, dust-free, non-palatable, non-toxic, able to be sterilised if needed, and suitable for the particular research purpose. Pregnant animals must be provided with nesting materials where appropriate.

Investigators and animal carers are referred to the publication Housing for Laboratory Rats, Mice, Guinea Pigs and Rabbits by A.L. Hargreaves published by ANZCCART in 2000 for more detailed information.

The AEC and relevant investigators should be informed in advance of planned changes to these conditions, since these may affect the welfare of the animals and the results of experiments.

4.6 Farm animals (special considerations)

The factors, criteria, and considerations for caging and housing discussed previously also apply to farm animals. However, animals on farms may be housed under less stringent conditions.

In general, housing and management practices should be designed to provide optimal animal care, and should follow the standards set in the Code of Welfare for the particular species concerned. A basic requirement is protection against environmental extremes. In determining optimal care, the criterion should be animal well-being rather than the mere ability to survive and reproduce under adverse conditions such as climatic extremes or high population densities.

Design criteria and choice of construction materials for livestock housing should meet the needs for the specific research and management practices. To the extent possible, all material used for indoor facilities should be impervious to moisture, insects, and vermin. Concrete and metal are the preferred building materials. Wood can be satisfactory, but it must be properly painted and sealed if extensive cleaning and disinfection procedures are to be carried out.

Floors and other paved surfaces should have textures that minimise slipping and possible injury. Fencing should be properly maintained to prevent injury. Ruminants require a resting area either in a well-drained outside area or bedded shelter. Control of air, temperature, relative humidity, air velocity, moisture, dust, light, gas accumulation, odours, space, and manure become of increasing concern in shifting from climatic housing to a totally controlled environment.

When animals are fed in groups, there should be sufficient trough space or feeding points to avoid undue competition for food, especially if feed is restricted. Feeding space is determined by the size and number of animals that must eat at one time.

An adequate water supply is also essential. Water sources should be easily accessible to animals of all ages and designed to prevent faecal contamination. Feed and water equipment should be constructed of materials that can be easily and effectively cleaned.

4.7 Enrichment and environmental complexity

Most animals used in research, testing and teaching are housed in unnatural environments. Wherever possible, such animals should be provided with stimuli that promote the expression of the normal patterns of behaviour that are appropriate to the particular species.

Almost all the species of animals used in research, testing and teaching have well defined social structures and prefer to live in groups, although care must be taken to ensure that animals are socially compatible. Individual housing is stressful for such animals, and social isolation should be avoided whenever possible and limited to meet the specific research objectives. The effects of physical isolation should be minimised where possible by the use of non-contact communication, whether visual, auditory or olfactory. Judicious use of mirrors can also be helpful, as can an environment of increased complexity.

A range of equipment, objects and gnawing sticks placed in the cage or primary enclosure can be used to increase the cage complexity and promote effective utilisation of vertical cage space for species which can climb. Such enrichment devices appear to be used by most species with a resultant increase in physical activity, reduction in aggression and traumatic injury, and can fulfil the animals' innate need to gnaw.

5. Management of Animals in Breeding and Holding Areas

5.1 Management and Staff

5.1.1 Person-in-charge

Small animal facilities, animal acquisition, breeding and holding facilities should be supervised by persons with appropriate veterinary or animal care qualifications or experience. Large animal acquisition, breeding and holding/housing facilities should be under the control of a farm manager or a person experienced in managing and handling large animals. Adequate veterinary care should be provided for all animals held for breeding and for experimental manipulations. The person-in-charge, or their nominee, should have ready access to institutional or consultant veterinary services seven days a week.

The person-in-charge should:

be responsible for the management of the day-to-day care of the animals in holding and breeding facilities and for supervising the work of other staff in the facility, and should act as liaison between investigator and facility staff;
contribute to the development and maintenance of the institution’s animal care policies and procedures;
ensure that there is reliable monitoring of the well-being of all animals by other staff, and be knowledgeable regarding signs of pain, distress and illness specific to each species housed. After animals are allocated to an approved project, the investigator has primary responsibility for ensuring adequate monitoring of the animals’ well-being;
ensure that ill or injured animals which are not assigned to approved projects are treated promptly and that the cause of death is investigated for animals which die unexpectedly;
ensure that staff are provided with appropriate protective clothing, maintain high standards of personal hygiene and do not eat, drink or smoke in animal areas;
for small animal facilities, document procedures used in the management of holding and breeding facilities. These procedures should take into account the requirements of the species held, the experiments being conducted, and the health and safety of the staff, and include transport, quarantine and disposal of animals, routine husbandry, prevention, diagnosis and treatment of disease, monitoring of health status and genetic constitution, and physical environmental factors. These procedures should be made known to all staff involved in the care and use of the animals and should be reviewed regularly. For large animals, transport and routine husbandry procedures as recommended in the relevant Codes of Welfare should be followed unless alternative procedures have been approved by the animal ethics committee;
for small animal colonies, maintain a regular schedule of cage, equipment and facility sanitisation to ensure that potential pathogens are kept at minimum levels in the environment;
for small animal colonies, ensure that adequate records are maintained of:
- the source, care, allocation, movement between locations, use and disposal of all animals, and of any diseases developed;
- the fertility, fecundity, morbidity and mortality in animal breeding groups, in order to monitor the management of the groups, and to assist detection of the origin and spread of disease; and
- the health status, genetic constitution and the physical environment of the animals, when definition of these is required.

Records maintained by the person-in-charge of small animal colonies must be made available to investigators.

The person-in-charge should ensure that investigators are informed of any changes to the conditions under which animals are held and which may affect their experiments.

5.1.2 Staff

The most important factor ensuring high standards of animal care is sufficient number of well-trained, committed staff. Personnel working with animals in a holding facility should be appropriately instructed in the care and maintenance of those animals, how they may affect the animals' well-being and how their actions may affect the outcome of experiments.

Institutions should encourage and promote formal training in animal science or technology (see Appendix II for a list of courses).

Personnel employed in the care of animals should be instructed in how to recognise at an early stage changes in animal behaviour, performance and appearance.

New staff who will care for animals should be appropriately instructed in their duties and in institutional policy.

Staff should be informed of allergy hazards and the important zoonotic diseases of animals under their care and of precautions that should be taken. Regular health checks and appropriate immunisation (e.g. against tetanus and other zoonoses) of all staff who handle animals are recommended in the interest of both staff and animals.

5.2 Husbandry procedures

5.2.1 Food and water

Animals should receive appropriate, uncontaminated and nutritionally adequate food according to accepted requirements for the species. The food should be in sufficient quantity and of appropriate composition to maintain normal growth of immature animals or normal weight of adult animals and to provide for the requirements of pregnancy or lactation. Uneaten perishable food should be removed promptly unless contrary to the needs of the species. Where possible, alteration to dietary regimes should be gradual.

Drinking water should be constantly and reliably available, and be clean, fresh and uncontaminated.

Variations to these requirements as part of an experimental project must receive prior AEC approval.

5.2.2 Routine husbandry procedures

Husbandry procedures which are not part of an approved experiment, e.g. clipping coats and nails, or immunisations, must be performed by competent personnel.

Routine husbandry procedures on animals should be carried out in accordance with relevant legislation and Codes of Welfare.

5.3 Identification of animals

Animals should be identified by a method such as tattoo, neck-band, individual tag, electronic numbering device, physical mark, or by a label or marking attached to the cage, container, pen, yard or paddock in which the animals are kept.

The person-in-charge of the facility is responsible for ensuring that animals are identified before allocation to an approved project, after which time both the person-in-charge and the investigator are responsible.

The method of identification should be reliable and cause the least stress possible.

5.4 Disposal of animal carcasses and waste

Appropriate provision must be made for prompt and sanitary disposal of animal carcasses and waste material in accordance with HSNO and ERMA legislation, local council by-laws and community standards.

6. Responsibilities of Investigators

6.1 General

People who use animals for scientific purposes have an obligation to treat the animals humanely and to consider their welfare as an essential factor when planning and conducting experiments.

Investigators have direct and ultimate responsibility for all matters related to the welfare of the animals under their control, including the general husbandry and housing of those animals as well as the specific experimental manipulations. They should act in accordance with all requirements of this guide. The responsibility of investigators extends over all facets of the care and use of animals in projects approved by the AEC, beginning when the animal is allocated to the approved project and ending at the time of disposal of the animal. Investigators are responsible for the standard of animal care and use by all other persons involved in the experiment. They should ensure that the extent of supervision is compatible with the level of competence of each person and the responsibilities they are given.

However, it is recognised that in many institutions the responsibility of managing routine animal husbandry is delegated to professional animal care staff on a daily basis. Strategies must be in place for the person-in-charge to effectively communicate with the investigator regarding animal welfare and research concerns.

Investigators have a legal and ethical responsibility to ensure that animals on study are manipulated using medical and surgical techniques, which are consistent with the principles of good practice and scientific knowledge in the discipline of laboratory animal veterinary medicine. Investigators should consult with veterinarians whenever adverse effects occur, in order that standard veterinary care treatment regimes are immediately implemented. This responsibility parallels the public's duty of care to seek veterinary management of any sick animals in their charge.

6.2 AEC approval

Before any project begins, investigators must submit a proposal to the AEC, which demonstrates that the project will comply with the Animal Welfare Act 1999. Moreover, the investigators must satisfy the AEC of their competence to conduct the techniques described in the experiment.

Investigators must not begin experiments before written AEC approval is obtained and must adhere to any requirements of the AEC.

Investigators may, however, obtain and hold for adaptation species, which are not otherwise readily available, prior to formal AEC approval, provided that their research use does not commence until approval is given.

Animal ethics committees have overall responsibility in ensuring that the institution and its investigators comply with current legislation in respect of the use of animals in research, testing and teaching.

Species requiring special permission from other organisations (e.g. Department of Conservation) must not be obtained and held before such approval is granted. (see section 3. Acquisition of Animals).

Investigators should inform the AEC when each project is completed or discontinued. As part of its role in monitoring manipulations the AEC should also be informed of the outcome of the project.

6.3 Planning projects

It is essential that investigators carefully plan their experimental protocol. This guide raises important issues for consideration which may lead to adjustments to the final protocol for submission to the AEC.

Choice of Animal - Investigators must ensure that the choice of species is appropriate for the purpose of the project. Requirements for known genetic constitution, freedom from specific diseases, documented health, nutritional and environmental histories, and other relevant factors should be taken into account. When the definition of the biological status of animals is necessary, investigators must ensure that the supplier can provide adequate proof that any requirements can be met. Where relevant, species and individual animals should be chosen on the basis that the proposed experiments will result in the least pain and distress. In making this decision, all aspects of the biological nature of the animals, including their behavioural characteristics and their cognitive development, should be taken into account.

Monitoring - Investigators should ensure that all intensively managed animals are observed daily (or more frequently if circumstances require it) to assess their health and welfare. Investigators should ensure that satisfactory arrangements are made for contacting them and other responsible persons in the event of emergencies.

Record-keeping - Investigators should ensure that their experimental research records include details of animal husbandry routine, environmental conditions, and other potential non-experimental variables which may affect the study. Records must also meet the statistical reporting requirements of the Animal Welfare (Records and Statistics) Regulations 1999, as detailed in MAF's publication "Animal Use Statistics", which is supplied to all code holders.

Consultation - Investigators should consult other experienced scientists, veterinarians, or laboratory animal, livestock or wildlife specialists when necessary.

Checklist - When planning is completed, the investigator should re-check the protocol to ensure that the following points have been adequately covered:

Is the project justified ethically and scientifically?
Can the aims be achieved without using animals?
Are there any additional experiments that could be included which would reduce the number of animals used?
Are suitable holding facilities and competent staff available?
Have all staff been informed of the planned experimental and other procedures?
Has the most appropriate species of animal been selected?
Is the biological status (genetic, nutritional, microbiological, general health) of the animals appropriate?
Are the environmental conditions (including caging or pen type, noise, photoperiod, temperature, humidity, ventilation, density of housing and social structures) appropriate?
Are the experiments designed so that statistically valid results can be obtained or the educational objectives achieved using the minimum necessary number of animals?
If the scientific activity could cause the animals any pain or distress, what will be done to minimise or avoid this?
What arrangements will be made to monitor the animals adequately, in terms of both their general health and welfare and their response to manipulation?
If any of the experiments have been performed previously, why should they be repeated?
If any animals are to be used repeatedly, what will be done to minimise the cumulative effects of such use?
Are there any permits that must be obtained for the importation, capture, use, destruction or release of the animals?

6.4 Conduct of experiments

6.4.1 Limiting pain and distress

Pain and distress cannot always be adequately evaluated in animals and investigators must therefore assume that animals experience pain in a manner similar to humans. Decisions regarding their welfare in experiments must be based on this assumption unless there is evidence to the contrary.

The investigator should anticipate any potentially adverse effects of a manipulation and take all possible steps to avoid or minimise pain and distress.

These steps should include:

choosing the most appropriate and humane method for the conduct of the experiment;
ensuring the technical skills and competence of all persons involved in animal care and use;
use of pre-emptive analgesia when pain is anticipated;
ensuring that animals are adequately monitored for evidence of pain and distress;
developing a plan to manage any adverse effects of a manipulation;
acting promptly to alleviate pain and distress;
using anaesthetic, analgesic and tranquillising agents appropriate to the species and the experimental purposes;
developing study endpoints that minimise pain and distress;
conducting projects over the shortest time practicable; and
using appropriate methods of euthanasia.

The use of local or general anaesthetics, analgesics or tranquillisers must be appropriate to the species, and should meet the criteria generally accepted in current medical, laboratory animal or veterinary practice.

Experiments which are liable to cause pain of a kind and degree for which anaesthesia would normally be used in medical or veterinary practice must be carried out under anaesthesia.

Distress can sometimes be avoided or minimised by non-pharmacological means. Before an experiment begins, animals should be appropriately conditioned to the experimental environment and procedures, and be familiar with animal care staff. During and after experiments, appropriate nursing procedures to minimise pain and distress, and to promote the well-being of the animals should be provided.

The monitoring of animals must at all times be adequate to prevent the occurrence, or allow prompt alleviation, of pain or distress.

If animals develop signs of severe pain or distress despite the precautions outlined above, they should have the pain or distress alleviated promptly or must be killed humanely and without delay. Veterinary consultants involved in the animal care programme should be informed immediately. Alleviation of such pain or distress takes precedence over continuing or finishing the experiment. If in doubt, investigators must always seek a professional veterinary opinion before continuing an experiment.

Unexpected deaths occurring during a project must be properly investigated by a veterinarian or other qualified person to determine the cause and initiate remedial action. If the deaths are due to manipulations, these must cease. The AEC must be notified and the project protocol resubmitted with appropriate modification.

6.4.2 Animal welfare monitoring of pain or distress

Investigators should be familiar with the normal behaviour of the animal species chosen, be knowledgeable of signs of pain or distress specific to that species, and must monitor their animals for these signs (see Appendix III).

Animals should be monitored to allow detection of deviations from normal behaviour patterns. Such deviations are often the first indications that animals are experiencing pain or distress. Any changes in patterns of sleeping, feeding, drinking, grooming, exploratory behaviour, performance in learning or discriminatory tasks, reproduction or social behaviour should be noted, assessed and acted on if appropriate.

Animals must be monitored appropriately for clinical signs of acute pain or distress. These may include one or more of the following:

aggressive and/or abnormal behaviour (some species may become unduly submissive);
abnormal stance or movements;
abnormal sounds;
altered cardiovascular and/or respiratory function;
abnormal appetite;
rapid decline in body weight;
altered body temperature; and
vomiting and abnormal defecation or urination.

Indicators of sustained pain or distress may include:

aggressive and/or abnormal behaviour (some species may become unduly submissive);
abnormal stance or movements;
abnormal sounds;
altered cardiovascular and/or respiratory function;
abnormal appetite;
rapid decline in body weight;
altered body temperature; and
vomiting and abnormal defecation or urination.

(See Appendix I for further information on pain).

Animal welfare monitoring score sheets should be used to document the observations and collection of data listed above. For example, variations in body weight, water intake, and grooming behaviour can be recorded every 24 hours or more often as needed during the immediate post-operative period for surgical manipulations. Some sample monitoring sheets are included as Appendix III.

6.4.3 Study endpoints

For all but the most minor of manipulations, the investigator should develop humane study endpoints when preparing a project application. These can be used to judge when an animal should be euthanased in order to promote animal welfare.

Death as an endpoint is generally ethically unacceptable and should be fully justified. All animals found in a moribund state must be euthanased unless specifically justified as above and approved by the AEC. It is generally accepted that moribund animals give unreliable research data because they are frequently in a state of multiple organ failure. However, attention to best practice indicates that endpoints earlier than the moribund condition should always be used. Typically these are based on changes in body weight, tumour size, and/or body temperature combined with abnormal clinical condition.

For example, animals should be killed when:

they have lost more than 20% of their pre-study body weight; or
have lost more than 10% in 24hrs; or
when a tumour grows to more than 10% of the animal’s weight; or
when body temperature falls below a pre-set level (as determined by pilot studies which indicate that the level set is predictive of death); or
when animals self-mutilate limbs and feet; or
develop abscess formation.

6.4.4 Repeated use of animals in experiments

Individual animals should not be used in more than one experiment, either in the same or different projects, without the express approval of the AEC. However, appropriate re-use of animals may reduce the total number of animals used in a project, result in better design of experiments, and reduce stress or avoid pain to other animals.

When approving experiments involving the re-use of animals, the AEC should be satisfied that either (i) none of the procedures cause the animals pain or distress; or (ii) the second and subsequent studies produce little or no pain or biological stress to the animals (e.g. modifying diet, taking a succession of blood samples, repeated non-invasive recording procedures) and that the animals have recovered fully from the first experiment before further procedures are carried out.

6.4.5 Duration of experiments

Experimental duration should be sufficient only to provide answers to the questions asked.

Experiments, particularly those which involve any pain or distress, should be as brief as practicable. AEC approval must be sought for the continued long-term use of individual animals. The decision to continue must be based on the well-being of the animal and the absence of aversion to the experimental situation.

6.4.6 Handling and restraining animals

Animals should be handled only by persons instructed and competent in methods which avoid distress and do not cause injury.

The use of restraint devices is sometimes essential for the welfare of the animal and the safety of the handler. Restraint devices should be used to the minimum extent, for the minimum period required to accomplish the purpose of the experiment, and be appropriate for the animal.

Tranquillisers or anaesthetics may aid restraint but may prolong recovery from the procedure. When these agents have been used, recovery of the animals should be monitored.

Periods of prolonged restraint should be avoided. Where animals are in prolonged restraint, consideration should be given to their biological needs, including their behavioural requirements and the need for appropriate exercise, and they must be monitored regularly by a veterinarian or other qualified person not participating in the project. If any ill effects are shown, the animal should be removed from the restraint or the method modified.

6.4.7 Completion of projects

Upon completion of the project, animals must be returned promptly to either normal husbandry conditions or, if appropriate and permitted, to their natural habitat, or be euthanased.

Where practicable, investigators should share with other investigators tissue from animals being euthanased.

6.4.8 Euthanasia

When it is necessary to kill an animal, humane procedures must be used. These procedures must avoid distress, be reliable and produce rapid loss of consciousness without pain until death occurs.

The appropriate means must be readily at hand.
The procedures should be compatible with the aims of the experiments.
The procedures should be performed only by persons who have demonstrated to a veterinarian or other qualified person that they are competent in the methods to be used.
Animals should be killed in a quiet, clean environment, and normally away from other animals. There should be no disposal of the carcass until death is established.
Dependent neonates of animals being killed must also be killed or provision made for their care.
When fertilised eggs are used, the method of disposal must ensure the death of the embryo.

Investigators are referred to the monograph Euthanasia of Animals Used for Scientific Purposes published by the Australian and New Zealand Council for the Care of Animals in Research and Teaching (ANZCCART) in 1993 for specific recommendations for euthanasia of the various species of laboratory animals.

6.4.9 Autopsy

An autopsy should be performed when animals die unexpectedly. Investigators should consider the value of an autopsy for such animals. Post-mortem evaluation may identify one or more non-experimental variables which could compromise the remaining research subjects.

6.4.10 Pre-operative planning

Surgical success can be improved by careful attention to the following.

The use of healthy, disease-free animals will ensure more reliable research data. Investigators should consult the institutional veterinarian or other qualified person to assist in obtaining such animals.
Pre-operative physical examination can often identify potential problems, such as increased anaesthetic risk, which may compromise the surgical procedure. Sick animals should be rejected.
Pre-surgical fasting should be considered where appropriate for the species to minimise complications of anaesthetic administration.
Pre-operative antibiotic administration should be considered. This can ensure maximal blood levels of drug during the surgical procedure. Additional post-operative antibiotic treatment may be required.
Surgical time can frequently be reduced by practice on cadavers. This enables investigators to familiarise themselves with anatomical landmarks and streamline the experimental surgical procedures, thereby reducing the quantity of anaesthetic required. This will reduce the duration of post-operative recovery and promote animal well-being.
Pre-operative analgesia should be routinely used. Such pre-emptive use of analgesics can reduce the quantities of general anaesthetic agents required and prevent the induction of sensitisation of the central nervous system. Post-operative pain is best managed by pre-operative analgesic administration, followed by additional analgesics after surgery.

6.4.11 Surgery

Surgical procedures should be carried out under appropriate local or general anaesthesia. There should be adequate monitoring of the depth of anaesthesia and effects such as hypothermia, and cardiovascular and respiratory depression.

The choice and administration of anaesthetic, analgesic and tranquillising agents should be suitable for the species and appropriate for the purpose of the experiment. The use of such agents should parallel that in current medical, laboratory animal or veterinary practice.

Investigators should consider the value of a limited anaesthetic trial to familiarise themselves with new anaesthetic or analgesic drug combinations. Species and strain variation in drug metabolism can result in unexpected morbidity and mortality when dosages are extrapolated from published data. A limited trial, when combined with a non-survival surgical practice session, can provide invaluable information and promote surgical success and animal well-being in subsequent study animals.

Anaesthesia and surgery should be performed by competent staff with appropriate training and experience. All tissues should be handled with care and particular attention should be given to haemostasis. Instruction in surgical or anaesthetic techniques should be under the direct and constant supervision of such persons.

When more than one surgical procedure is to be performed the animal must have recovered to good general health between each procedure. Every effort should be made to reduce the total number of procedures and the AEC should be informed specifically of the need for more than one procedure.

When the animal is not to recover from the surgery, it must be unconscious for the whole procedure, either by continuing the administration of the general anaesthetic or by inducing brain death.

When the animal is to recover from the anaesthetic, surgical procedures must conform to accepted standards in laboratory animal and veterinary practice. Aseptic technique should be used for animals which undergo major survival surgery. This is defined as any surgical intervention that penetrates a body cavity or has the potential for producing a permanent handicap in an animal that is expected to recover. Aseptic technique includes aseptic preparation of the surgical field, use of sterilised instruments, wearing of sterile surgical gloves, gowns, caps, and face masks. The use of post-operative antibiotics should not be a substitute for correct aseptic technique.

6.4.12 Post-operative care

Consideration of pain relief is paramount in post-operative care.

Investigators should ensure that adequate monitoring, treatment and care of post-operative animals is provided. They should ensure that they, or other experienced personnel, are fully informed of the animals' condition. The duties of all staff must be clearly defined and ways of dealing with emergencies established.

The comfort of animals must be promoted throughout the post-operative period. Attention should be given to warmth, hygiene, fluid and food intake, and control of infection. The use of analgesics and tranquillisers may be needed to minimise post-operative pain or distress. Care should be taken that animals recovering from anaesthesia are housed to prevent injury and that conditions are such that they are not disturbed, attacked or killed by other animals in the same enclosure.

Appropriate clinical records should be kept, accessible to all involved in the post-operative care of the animal.

Regular observation of surgical wounds is essential to check the progress of healing. Any problems must be attended to immediately.

Any post-operative animal observed to be in a state of severe pain or distress which cannot be alleviated quickly must be killed humanely without delay and the consultant veterinarian informed immediately.

6.4.13 Implanted devices

Investigators should be aware of the need for strict attention to aseptic technique when foreign bodies are surgically implanted. Contamination of prosthetic devices frequently requires their removal after antibiotic therapy has failed.

Skilled and specialised attention is required in the care of animals following an operation in which monitoring or sampling devices have been implanted, or a fistula created. Regular observation is essential to determine signs of distress, pain or infection which must be treated immediately.

6.4.14 Neuromuscular paralysis

Neuromuscular blocking agents must not be used without adequate general anaesthesia or an appropriate surgical procedure which eliminates sensory awareness.

Immobilisation of an animal solely with a neuromuscular blocking agent is not acceptable. When these agents are used with an anaesthetic, special care must be taken to ensure the maintenance of an adequate plane of anaesthesia. Since criteria such as character of respiration and corneal and flexor withdrawal reflexes cannot be used, continuous or frequent intermittent monitoring of physiological variables such as heart rate, blood pressure, oxygen saturation, pupil size and electroencephalogram is necessary, together with the effects on these of mild sensory stimuli. Care is required to ensure that drugs used in the experiments do not interfere with this monitoring.

6.4.15 Electroimmobilisation

Electroimmobilisation must not be used as an alternative to analgesia or anaesthesia. When its use is proposed for the restraint of animals, AECs must carefully evaluate published evidence to assess whether it may cause distress. If so, an alternative restraint method must be used.

6.4.16 Animal models of disease

The scientific validity of animal models of human diseases rests in part on how closely they resemble a particular disease. Thus, the attendant pain and distress of the human disease may also occur in the animal. Special care must be taken in selecting the appropriate species, and the investigator must accept responsibility for ensuring that any pain or distress is minimised and that the AEC is informed of the potential effects of the disease on the animals.

Investigators must not allow the experiments to proceed to the painful or distressful or lingering death of animals unless no other experimental endpoint is feasible and the goals of the experiments are the prevention, alleviation, treatment or care of a life-threatening disease or situation in human beings or animals.

Investigators must avoid using death as an experimental endpoint whenever possible. When death as an endpoint cannot be avoided, the experiments must be designed to result in the deaths of as few animals as possible.

6.4.17 Modifying animal behaviour

Procedures used to modify an animal's behaviour or to induce it to perform specific tasks depend on motivating the animal. The preferred inducement is positive reinforcement, but the inducement may be some form of biological stress. This stress should be as mild as possible. Severe water, food, social or sensory deprivation should not be used. Painful or noxious stimuli should be limited to those which do not distress human beings and must be used for the minimum time necessary. Behaviour can usually be modified using procedures that involve no more of a stressor than that normally experienced by the species. When noxious stimuli are used to modify behaviour the AEC should be aware of the duration and possibility of escape from the stimuli.

6.4.18 Toxicological experiments

Investigation of the safety of agents intended for use in human beings, animals, the household or the environment, or of naturally occurring toxins, should be performed by persons with appropriate training. If suitable non-animal tests are available, they must be used. In particular, in vitro methods should be used as an initial screening test wherever possible.

The endpoint of such experiments must be as early as is compatible with reliable assessment of toxicity, and must minimise the extent of any pain and distress.

When death as an endpoint cannot be avoided, the experiments must be designed to result in the deaths of as few animals as possible.

6.4.19 Experiments involving hazards to humans or other animals

Hazards may arise from sources that include:

viruses;
bacteria;
fungi;
parasites;
radiation;
radioactivity;
corrosive substances;
toxins;
allergens;
carcinogens;
recombinant DNA;
anaesthetic gases; and
physical injuries.

Any potential pathogenic effects of these hazards when used in experiments must be explained as far as possible to all staff. Tests before, during and after the experiments may be required for staff.

The investigator should inform the AEC that the advice of the institution's biohazards committee (where it exists) has been sought and that appropriate measures for containment, disposal and decontamination have been established.

Protocols submitted to the institution's AEC should include a description of any intended use of hazardous compounds or organisms. They should describe specific safety measures and disposal protocols used to prevent contamination of caging, other animals, research personnel and students.

Animals being administered infectious organisms should be isolated as appropriate, taking into account risks to other animals and to people.

Precautions, security and emergency plans to contain hazardous agents must be appropriate to a "worst-case" situation.

6.4.20 Experimental manipulation of animals' genetic material

All work involving the introduction of foreign DNA into mammalian cells or whole animals must be conducted in accordance with guidelines issued by the Advisory Committee on Novel Genetic Techniques.

All proposals to manipulate the genetic material of animals, their germ cells or embryos must also be submitted to an AEC for approval.

The manipulation of the genetic material of animals has the potential to affect the welfare of the animals and their offspring adversely. Investigators must inform the AEC of the known potential adverse effects on the well-being of the animals.

The clinical status of animals in which the genetic material has been manipulated experimentally must be monitored for unusual or unexpected adverse effects, and such effects reported to the AEC.

There are examples of strains in which pathological conditions can be generated by normal breeding procedures. Expert care should be available to look after the welfare of such animals.

6.4.21 Experimental induction of neoplasia

The site for induction of tumours must be chosen carefully. Subcutaneous, intradermal and flank sites should be chosen when possible. Prior to the use of footpad, brain and eye sites, specific justification as to the lack of any alternative should be made to the AEC.

Investigators should monitor their animals regularly for signs of pain or distress, especially sudden changes in body weight.

Animals with experimentally induced tumours should be euthanased whenever possible before predictable death occurs, cachexia becomes advanced, or the tumour becomes large enough to cause ulceration or severe limiting of normal behaviour.

With ascitic tumours, including hybridomas, investigators should ensure that the volume of ascitic fluid does not cause gross abdominal distension, and the volumes of solid tumours and cachexia do not become distressful to the animals.

In tumour therapy experiments, the endpoints chosen should be as early as possible, compatible with reliable assessment of the therapy. Weight changes should be monitored closely. Death from the tumour should not be chosen as an experimental endpoint unless no other experimental endpoint is feasible and the goals of the study are the alleviation, treatment or cure of life-threatening disease situations in human beings or animals.

6.4.22 Lesions of the central nervous system

Anatomical or chemical lesions of the central nervous system have been widely used to study its structure and function in health and disease. These experiments demand special consideration when the lesion produces loss or impairment of limb or trunk movements, loss of sensibility to touch, temperature or pain, impairment of the animal's awareness of its surroundings or impairment of appetite or injury mechanisms. Special animal care, caging, and other facilities may be needed and the AEC, in approving such experiments, has a particular responsibility to ensure that these facilities are available and that the condition of the animals is closely monitored.

6.4.23 Withholding food or water

Experiments involving the withholding or severe restriction of food or water should produce no continuing detrimental effect on the animals. In these experiments, the fluid balance and/or body weight must be monitored, recorded and maintained within the limits approved by the AEC.

6.4.24 Foetal experimentation

When foetal experimentation or surgery compromises the ability of the neonate to survive and be without pain or distress, it must be euthanased before or immediately following birth unless such pain or distress can be relieved.

Unless there is specific evidence to the contrary, investigators must assume foetuses have the same requirements for anaesthesia and analgesia as adult animals of the species.

During surgery of the mother, consideration must be given to any special requirements for anaesthesia of the foetus.

Eggs must be destroyed before hatching, unless hatching is a requirement of the experiment. The AEC must approve the arrangements made for hatchlings.

6.4.25 Research on pain mechanisms and the relief of pain

In experiments in which unanaesthetised animals are to be subjected to stimuli designed to produce pain or when pain is to be inflicted on animals as part of normal management, investigators should: · ensure that these stimuli limit pain at all times to levels comparable to those which do not distress human beings; · ensure that the animals are exposed to the minimum pain necessary for the purpose of the experiment; and · provide treatment for the relief of pain, or allow self-administration of analgesics, or escape from repetitive, painful stimuli when possible.

6.4.26 Animal welfare and animal health research

When studying ways of improving the health and welfare of animals, investigators may need to design experiments that replicate the problem such as injury, trauma, nutritional disorder, physical exertion, disease or environmental stress. Thus, the attendant pain and distress may also be replicated. When such experiments are necessary, the investigator must ensure that: · the principal aim of the project is to improve animal health or welfare; · alternative methods, such as the use of animals already subjected to the problem, are not possible; · all possible steps are taken to minimise any pain or distress; and · the experiments do not proceed to the painful or distressful or lingering death of animals unless no other experimental endpoint is feasible and the goals of the experiments are the prevention, alleviation, treatment or care of a life-threatening disease or situation. When death as an endpoint cannot be avoided, the experiments must be designed to result in the deaths of as few animals as possible.

7. Responsibilities of Teachers

7.1 Tertiary institutions

When animals are being used to achieve educational objectives the person in charge of the class must:

accept ultimate responsibility for ensuring that the care and use of the animals is in accordance with this guide and all relevant legislation;
have relevant training and qualifications;
consider whether alternative teaching methods can be used;
obtain prior AEC approval for use of all animals for the entire course;
instruct students appropriately in the care and use of animals before those students participate in experiments with live animals;
ensure that there is close, competent supervision of all students;
allow students to anaesthetise animals or carry out surgery only if it is essential for their training; and
be responsible for the humane killing of the animals, if required, bearing in mind that it is good practice to segregate manipulated animals from animals held under normal living conditions.

Persons supervising students who are training in research must ensure that the students are appropriately instructed prior to using animals and must be responsible for the welfare of animals used by students.

7.2 Secondary and primary schools

Use of animals in secondary and primary schools must comply with policies on the use of animals in teaching issued by educational authorities. The Gazetted Code of Ethical Conduct of the former Department of Education is still applicable to all state and integrated schools.

A list of existing regional AECs for schools is available from the Ministry of Agriculture and Forestry. It is anticipated that this programme will expire on 31 December 2002.

8. Access to Further Information

Published material on the use of animals for scientific purposes and alternatives to animal use is being extended almost daily. A bibliography would be too extensive to publish in this code. However, a minimal list would include the following:

ANZCCART (1993) Euthanasia of Animals Used for Scientific Purposes.

Flecknell, P., Waterman-Pearson (2000) Pain Management in Animals W.B. Saunders, London.

Flecknell, P.A.(1996) 2nd ed. Laboratory Animal Anaesthesia A Practical Introduction for Research Workers and Technicians London Academic Press.

Hargreaves, A.L. (2000) Housing for Laboratory Rats, Mice, Guinea Pigs and Rabbits ANZCCART.

Monamy, V.M. (1996) Animal Experimentation: A Student Guide to Balancing the Issues ANZCCART.

National Health and Medical Research Council (1997) Australian Code of Practice for the Care and Use of Animals for Scientific Purposes (6th ed.).

Poole, T. (ed.) (1999) The UFAW Handbook on the Care and Management of Laboratory Animals (7th ed.) Blackwell Science.

Institutional libraries will have access to bibliographies through database searches.

The Ministry of Agriculture and Forestry has entered into a Memorandum of Understanding with the United States Department of Agriculture for certain New Zealand institutions to have access to the Animal Welfare Information Center (AWIC) in the United States. AWIC is part of the National Agricultural Library of the United States Department of Agriculture and is located in Beltsville, Maryland.

For further information see Appendix IV.

The Australian and New Zealand Council for the Care of Animals in Research and Teaching (ANZCCART) publishes a fact sheet on individual species of laboratory animals. Copies are available from:

Executive Officer
ANZCCART
PO Box 598
Wellington

Appendix I Pain: Some Concepts and Definitions

1. Pain

"What level of pain do we allow?" is a question facing all animal ethics committees. It is a matter which involves constant assessment of pain and stress levels of proposed research. The AEC must somehow reconcile the physical and psychological consequences for the animal with the objectives of the proposed investigation.

The concept of pain is subjective and difficult to define. The leading research journal Pain applies the following criterion:

Pain in animals is manifested by abnormal behaviour which can be alleviated by analgesic procedures which relieve pain in humans.

Flecknell, states: Until further progress is made in assessing the nature of pain in animals, it should be assumed that if a procedure is likely to cause pain in man, it will produce a similar degree of pain in animals

The Swiss Academy of Sciences has outlines a set of Ethical Principles and Guidelines for Scientific Experiments on Animals. One of their statements is:

Experiments apt to cause the animal severe suffering must be avoided by modifying the hypothesis to be tested in such a way that the other criteria of the successful conclusion of the experiment can be applied, or by foregoing the anticipated gain of knowledge. Severe suffering is to be construed as any state which in man would be qualified as unbearable without palliative measure.

2. Pain and Distress

Pain is an awareness of acute or chronic discomfort, occurring in varying degrees of severity, and resulting from injury, disease, or emotional distress as evidenced by biological or behavioural changes or both.

Acute Pain results from a traumatic, surgical or infectious event that is abrupt in onset and relatively short in duration. It is generally alleviated by analgesics.

Chronic Pain results from a long-standing physical disorder or emotional distress that is usually slow in onset and has a long duration. It is seldom alleviated by analgesics but frequently responds to tranquillisers combined with environmental manipulation and behavioural conditioning.

Distress is an undesirable physical or mental state resulting from pain, anxiety, or fear. Its acute form may be relieved by tranquillisers. Sustained distress, however, requires environmental change and behavioural conditioning and does not respond to drug therapy.

3. Analgesia and Anaesthesia

A working knowledge of the following terms will be beneficial to AEC members to better understand pain in animals.

Analgesia refers to prevention of pain or relief of pain.

Tranquillisation is a state of behavioural change in which the patient is relaxed and unconcerned by its surroundings. In this state the animal is often indifferent to minor pain.

Sedation is a mild degree of central depression in which the patient is awake but calm. Narcosis in humans is defined as a drug-produced state of deep sleep accompanied by analgesia. In veterinary medicine, the narcotised patient is seldom asleep but is sedated and oblivious to moderate pain.

Hypnosis is a condition of artificially induced sleep, or a trance resembling sleep, resulting from moderate depression of the central nervous system.

Local anaesthesia is the loss of sensation in a limited area of the body.

Regional anaesthesia is insensibility in a larger but limited area of the body.

Basal anaesthesia is a light level of general anaesthesia usually produced by pre-anaesthetic agents. It serves as a basis for deeper anaesthesia on administration of other agents.

General anaesthesia is complete unconsciousness.

Surgical anaesthesia is unconsciousness accompanied by muscular relaxation to such a degree that surgery can be performed painlessly without struggling on the part of the patient.

4. Signs of Pain

An animal in pain, regardless of species displays one or more of the following signs:

attraction to the area of pain;
increased skeletal muscle tone;
altered electroencephalogram (EEG) response;
increased blood pressure and heart rate;
pupillary dilation;
change in the respiratory system.

(a) Signs of Acute Pain

protection of the painful part;
vocalisation (especially on movement or palpation of painful area);
licking;
biting;
scratching or shaking of affected area;
restlessness;
sweating;
increased rate of respiration;
unusual immobility or reduction in mobility.

(b) Signs of Chronic Pain

limping (if painful part is an appendage);
licking of area affected;
licking of other areas if the painful part cannot be reached;
reluctance to move;
loss of appetite;
change in personality;
change in eye brightness.

In compiling general guidelines it has become clear that there are species specific signs of pain which should be taken into account when making a practical assessment. Experience has taught that such signs are often associated with what is believed to be a painful condition, although no sign can by itself be regarded as diagnostic of pain and may also occur in conditions in which pain is unlikely to be a feature.

Although a comprehensive description of species specific signs has not been produced, the following notes and comments might be helpful.

(i) Primates

(Primates are not currently used in research in New Zealand. However, for completeness the following is included).

Monkeys often show remarkably little reaction to surgical procedure or to traumatic injury. Obvious signs of pain are not readily seen. Loud and persistent vocalisation is unlikely to be an expression of pain, but it is more likely to signify alarm or anger.

Pain gives rise to a general appearance of misery and dejection. The animal may be huddled in a crouching posture with a 'sad' facial expression and glassy eyes; it may moan, avoid its companions and may stop grooming itself. A monkey in pain may also attract increased attention from its cage mates. This can vary from social grooming to attack.

Acute abdominal pain may be shown by facial contortions, clenching of teeth, restlessness and shaking accompanied by grunts and moans. Food and water are usually refused.

(ii) Horses

The following signs are associated with pain: periods of restlessness; interrupted feeding with food held in the mouth uneaten; anxious appearance with dilated pupils and glassy eyes; increased respiration and pulse rate with flared nostrils; profuse sweating and a rigid stance.

In prolonged pain, behaviour may change from restlessness to depression with head lowered. In pain associated with skeletal damage, limbs may be held in unusual positions and there is a reluctance to move with head and neck 'fixed'. In abdominal pain, a horse may look at, bite or kick its abdomen; it may get up and lie down frequently; walk in circles; roll and injure itself as a result of these activities. This state may progress and can last for several hours. When near collapse, the horse may stand very quietly rigid and unmoving. Horses in pain generally show a reluctance to be handled.

(iii) Cattle

Cattle in pain often appear dull and depressed with little interest in their surroundings. There is loss of appetite, weight loss and, in milking cows, a sudden drop in milk yield. Severe pain often results in rapid shallow respiration. On handling they may react violently or adopt a rigid posture designed to immobilise the painful region. Grunting and grinding of teeth may be heard. Generally signs of abdominal pain are similar to those seen in the horse but are less marked. Rigid posture may lead to a lack of grooming because of an unwillingness to turn the neck.

(iv) Sheep and Goats

In general, signs of pain in sheep and goats are similar to those in cattle. Changes in posture and movement are apparent and a change in facial expression may be indicative of pain. Goats in particular are more likely than cattle to vocalise in response to pain. Grinding of teeth and grunting are also heard.

(v) Pigs

Pigs in pain may show changes in gait and posture. Pigs normally squeal and attempt to escape when handled but these reactions may be accentuated when in pain. Pigs will often be unwilling to move and may hide in bedding if possible.

(vi) Dogs

Dogs in pain generally appear quieter and less alert with stiff body movements and an unwillingness to move. In severe pain the dog may lie still and adopt a crouching attitude. In less severe states it may appear restless. There may be loss of appetite and shivering and increased respiration with panting. Spontaneous barking is unlikely, the dog is more likely to whimper or howl, especially if unattended and may growl without apparent provocation. A dog may bite or scratch at painful regions and may become more vicious when handled.

(vii) Cats

Cats in pain are generally silent, but may growl or hiss if approached. There is loss of appetite and a tendency to hide. Posture becomes stiff and the cat may sit hunched lying on its chest being reluctant to stretch out. A cat in severe pain may howl and show demented behaviour and desperate attempts to escape. Incessant licking is sometimes associated with pain. More usually the cat has a generally miserable ungroomed appearance with a change from its normal temperament. There may be panting with an increased pulse rate and dilation of the pupils.

(viii) Rabbits

Rabbits in pain may be apprehensive, dull, inactive and assume a 'hunched' appearance. They sometimes, however, show aggressive behaviour and activity may be increased with excessive scratching and licking. Reactions to handling are exaggerated and acute pain may result in vocalisation. Respiratory rate may be increased and there may be loss of appetite.

(ix) Laboratory Rodents

Pain in rodents usually results in decreased activity, hair standing on end and an ungroomed appearance or there may be excessive licking and scratching. They may adopt an abnormal stance with a staggering gait, but rats and mice may become unusually aggressive when handled, and acute pain may cause vocalisation. Loss of appetite or a change in feeding activity may be noted and, if housed with others, a change in the normal group behaviour may be apparent.

(x) Birds

Birds in pain may show escape reactions with vocalisation and excessive movement. There may be an increase in heart and respiratory rates. Prolonged pain will result in loss of appetite and inactivity with a drooping miserable appearance. When handled the escape reaction may be replaced by a state of rigidity.

(xi) Fish

It is difficult to determine the nature of the response to pain in fish. Responses to harmful stress include an increased breathing pattern with excessive movement of fins.

5. Painful Procedures

A report on pain published by the Royal Society for the Prevention of Cruelty to Animals (England) lists the following procedures to experimental animals as cause for concern:

application of painful stimuli;
creation of short or long-term inflammation (paws, joints);
creation of animal models of human disease (renal failure, gastric and colonic ulcers, viral and bacterial infections, disorders affecting deep sea divers);
transplantation studies;
creation of tissue damage by radiation, often involving death as endpoints;
induction of convulsions by electroshock to the brain;
application of inescapable electroshock to feet or eye region;
exposure to stress (cold, restraint, forced swimming);
food deprivation for long periods,
maternal deprivation of infant primates;
toxicological studies involving severe and prolonged symptoms of illness, often ending in death;
administration of substances (possibly hallucinogenic in humans) causing disorientation or abnormal behaviour;
trauma research (burning, scalding, limb fracture, limb ischaemia);
testing antidote to biological warfare agents;
vaccine quality control assays involving death endpoints.

6. NAEAC's Views on Pain Relief

It is the view of NAEAC that animals should always be given the benefit of any doubt concerning pain relief.

Experiments which cannot be performed without unrelieved pain and distress should not be undertaken. Some experiments, even when some "good" results per se may be hoped for, should be forsaken altogether rather than subject animals to prolonged suffering or to intense pain even for short periods of time.

NAEAC concurs with the Canadian Council on Animal Care which classes as unacceptable:

the utilisation of muscle relaxants or paralytics alone, without anaesthetics, during surgical procedures; and
traumatising procedures involving crushing, striking or beating in unanaesthetised animals.

NAEAC is concerned about the present use and knowledge of effective analgesia for laboratory animals. There appears to be inadequate or contradictory data on the therapeutic effects of certain analgesic drugs for laboratory animals, and in particular, for small rodents which comprise the largest number of animals. Small rodents are rarely given analgesia.

According to Dr. Eugene M Wright, et al,

…analgesic drugs are often withheld because the clinician is not absolutely certain that an animal is experiencing pain, yet antibiotics are almost always given, even without documenting the presence of bacterial infection. Pain and suffering may actually constitute the only situation in which one should go ahead and treat even if in doubt.

NAEAC believes that the problem of relief of animal suffering merits higher priority in scientific enquiry.

Appendix II Animal Technician Courses

Auckland University of Technology
Bay of Plenty Polytechnic
Christchurch Polytechnic
Nelson Marlborough Institute of Technology (Nelson and satellite at Wallaceville)
Otago Polytechnic
Southern Institute of Technology (Invercargill)
UNITEC (Auckland)
Waikato Institute of Technology
Wanganui Veterinary Services

Appendix III Animal Welfare Score Sheet **

Animal/Species #____ Date of Treatment/Operation:___

Prestudy Bodyweight: ___Surgeon: AEC #:___

Date
Day
Time

From a distance

Inactive
Hunched posture
Coat rough/starey
Rate of breathing
*Type of breathing

On handling

Body wt gm
% change
Inquisitive
Diarrhoea
Dehydration
Vocalization
CNS signs seizures/ convulsions

Food and water

Food intake ok
Wt of full bottle
Wt of bottle today

Operation site

Wound OK
Bleeding
Other discharges
Sutures/clips OK

Post-op support

Analgesic administration

Drug
Dose
Fluid by subcut
Mls/day
Other
Signature

Scoring details:

* Breathing R = rapid, S = shallow, L = laboured, N = normal

Humane End-points:

Weight loss of 10% or more over 24 hrs
Weight loss of 20% or more plus one other clinical sign compared with control group
Weight loss of 25% compared with control group

** We acknowledge Professor David B. Morton, Centre for Biomedical Ethics, University of Birmingham UK, as the author of this clinical assessment scheme

How to use the Animal Welfare Score Sheet

Key points:

One score sheet per animal
The 12 boxes across the page can be used for 12 different time points
For critical post-op cases, animals should be checked every 4hrs ( three times per day)
It is recommended that a pre-operative examination be made of the animal before anaesthesia, to observe the animal. This is time zero in the first box.
Look for evidence of red discharge from nose or eyes ( a non-specific sign of stress)
Look at the coat, it should be groomed smooth and shiny. A rough/starey coat has fur standing on end, because the animal is too sick to groom itself.
Look for dehydration - if the skin can be gently pulled away from the body and remains that way, the animal is significantly dehydrated
Look at the breathing, note if it is laboured, rapid or shallow
Listen to the breathing, note any respiratory noises.
Look at the colour of the ears and feet. They should be pink.
Look at the behaviour of the animal. It should be inquisitive.
Record the weight of the water bottle before surgery.

Use this form to score and record:

Physical observations of clinical condition. This can be done in 2 ways:
- example 1: Score presence (+) or absence (-) of nose discharge or dehydration
- example 2: Graded score from 0-5 (0= no discharge, 5= max discharge)
Changes in physical condition with time, after surgery. When several animals are used simultaneously, it is difficult to remember how any individual animal looked the previous day
Administration of analgesic pain medication
Administration of subcutaneous fluids
Condition of the surgical sites, look for blood or other discharges
Fluid drunk by the animal. This is one of the best indicators of wellbeing. Animals in pain do not drink much. Healthy animals normally drink approximately 10% body wt per day. Hence a 300gm rat should drink 30mls every 24hrs
Weigh the water bottle and difference gives approximate volume consumed. If the animal is not drinking 10% of body wt per 24 hrs, it is probably in pain. Pain medication should be increased and additional fluid administered by subcutaneous injection. Seek veterinary advice on how to do this.

Appendix IV Animal Welfare Information Center

AWIC was established in 1986 and is a focal point for those interested in obtaining information or publications covering many aspects of animal welfare. The National Agricultural Library has over 2 million volumes and subscribes to 26,000 periodicals from around the world.

AWIC subject areas that will interest institutions using animals for scientific purposes include:

alternatives;
training;
pain management and control;
transport and acquisition;
humane treatment;
environmental factors;
animal care and use committees;
philosophy;
animal behaviour.

The AGRICOLA database is accessible through AWIC. AGRICOLA is a computerised database which is an index to more than 2.6 million books and articles relating to all aspects of agriculture. One-fifth of that database is devoted to laboratory animal science, veterinary medicine and animal production.

AWIC serves many types of users. For instance, AWIC can help:

a laboratory technician identify humane handling techniques for rabbits;
an administrator establish training courses for institutional laboratory animal technicians;
an AEC identify database management systems for monitoring laboratory animal care and use;
a veterinarian obtain information on the treatment of specific animal diseases or order to maintain optimal health;
a researcher formulate a comprehensive literature search on possible alternatives;
a private citizen to obtain recent regulations and legislation relating to animal welfare.

AWIC can help those people and others interested in learning more about methods for the humane care, use, and handling of animals in research, testing and education. AWIC can also refer subscribers to experts in a nominated field who can provide additional information.

The following organisations have direct access to AWIC:

MAF Information Bureau (for MAF staff inquiries)
ANZCCART (for sponsor members)
AgResearch (for research campuses at Invermay, Ruakura, Wallaceville and Lincoln)
Massey University
New Zealand Veterinary Association (for veterinary practitioners) and
NEW Animal Welfare Information Services (for animal welfare organisations, the agricultural industry, the pharmaceutical industry, farming organisations, and individuals).

Further information about these services can be obtained from the Secretary of NAEAC.

Page last updated: 21 October 2008

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Contents

1. Introduction

2. Purpose of this Guide

2.1 Purpose

2.2 Scope

2.3 Background to the guide

2.4 Comments on the guide

2.5 Definitions of terms and abbreviations used in this guide

3. Acquisition of Animals

3.1 Animals collected from their natural habitats

3.2 Animals obtained from other countries

3.3 Transport of animals

3.4 Admission of new animals into holding areas

4. Facilities

4.1 General

4.2 Outdoor holding areas

4.3 Indoor housing

4.4 Environmental factors

4.5 Pens, cages and containers and the immediate environment of the animals

4.6 Farm animals (special considerations)

4.7 Enrichment and environmental complexity

5. Management of Animals in Breeding and Holding Areas

5.1 Management and Staff

5.1.1 Person-in-charge

5.1.2 Staff

5.2 Husbandry procedures

5.2.1 Food and water

5.2.2 Routine husbandry procedures

5.3 Identification of animals

5.4 Disposal of animal carcasses and waste

6. Responsibilities of Investigators

6.1 General

6.2 AEC approval

6.3 Planning projects

6.4 Conduct of experiments

6.4.1 Limiting pain and distress

6.4.2 Animal welfare monitoring of pain or distress

6.4.3 Study endpoints

6.4.4 Repeated use of animals in experiments

6.4.5 Duration of experiments

6.4.6 Handling and restraining animals

6.4.7 Completion of projects

6.4.8 Euthanasia

6.4.9 Autopsy

6.4.10 Pre-operative planning

6.4.11 Surgery

6.4.12 Post-operative care

6.4.13 Implanted devices

6.4.14 Neuromuscular paralysis

6.4.15 Electroimmobilisation

6.4.16 Animal models of disease

6.4.17 Modifying animal behaviour

6.4.18 Toxicological experiments

6.4.19 Experiments involving hazards to humans or other animals

6.4.20 Experimental manipulation of animals' genetic material

6.4.21 Experimental induction of neoplasia

6.4.22 Lesions of the central nervous system

6.4.23 Withholding food or water

6.4.24 Foetal experimentation

6.4.25 Research on pain mechanisms and the relief of pain

6.4.26 Animal welfare and animal health research

7. Responsibilities of Teachers

7.1 Tertiary institutions

7.2 Secondary and primary schools

8. Access to Further Information

Appendix I Pain: Some Concepts and Definitions

1. Pain

2. Pain and Distress

3. Analgesia and Anaesthesia

4. Signs of Pain

5. Painful Procedures

6. NAEAC's Views on Pain Relief

Appendix II Animal Technician Courses

Appendix III Animal Welfare Score Sheet **