15 October 2010

'Animal Care' aims to provide direction to officers of Industry & Investment NSW and Livestock Health and Pest Authorities who carry out teaching, extension and research activities involving animals. It will:

• ensure that all educational and extension activities comply with the Animal Research Act 1985, the Animal Research Regulation 2005, and the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes;
• allow Animal Ethics Committee consideration of applications for approval to conduct teaching or research to be expedited. This will be achieved by the introduction of standard operating procedures for suitable educational and research activities involving agricultural animals.

1. Background

The Animal Research Act (the Act) was introduced to control the use of animals in research and teaching activities. The Act ensures proper ethical consideration of how and why animals are used. It reflects a general community view that animal use should be considered and humane. It is based on the underlying principles that people wishing to use animals for teaching or research should strive towards:

• a reduction in the numbers of animals used;
• the refinement of procedures involving animals to make them more humane; and 
• the replacement of the use of animals with non-living alternatives wherever practicable. (The '3 Rs')

These principles are spelt out and given legal force in the Code of Practice which is adopted into the Animal Research Regulation 2005.

Industry & Investment NSW and Livestock Health and Pest Authorities are major users of animals in educational and research activities in NSW. Many of these activities may appear to differ little from normal procedures conducted in commercial livestock enterprises. However, it must be emphasised that even normal husbandry activities are covered by the Animal Research Act when they are carried out for the purpose of demonstrating or teaching techniques or as part of a research project.

Animal Ethics Committees (AECs), representing research and animal welfare interests, are central to the operation of the legislation. Industry & Investment NSW has four AECs which oversee educational and research activities across the state. They have responsibility for initial approval and ongoing monitoring of these activities and also provide advice on proposed activities. However, responsibility for the welfare of individual animals during an educational or research activity ultimately lies with the officer conducting it.

The Act also establishes the Animal Research Review Panel (the Panel) as the central body responsible for overseeing the overall operation of the legislation and the development of policy recommendations. The Panel determines whether institutions are complying with the legislation by evaluating applications for accreditation and through site inspections. The Emergencies and Animal Welfare Unit (E&AWU) provides executive support to the Panel, and veterinary officers of the E&AWU have powers as inspectors under the Act.

Definitions

'Animal' is defined by the Act as any vertebrate animal (including mammals, birds, reptiles, amphibians and fish). This includes animals held by Industry & Investment NSW and Livestock Health and Pest Authorities, as well as privately owned animals.

'Research' includes the use of animals for educational activities and testing (including diagnostic tests) as well as original research and field trials. Normal husbandry procedures carried out for the purpose of teaching or demonstration or in the course of the conduct of original research or field trials are also considered to be 'research'.

'Research' DOES NOT include normal husbandry procedures carried out on agricultural animals as part of routine management. These procedures fall into Category 1 of the table in Section 5.

'Research' DOES NOT include veterinary treatment. Guidelines for determining whether an activity is research or veterinary treatment can be found in the document 'Differentiation between Acts of Research and Acts of Veterinary Treatment' on the Animal Ethics Infolink website.

An 'LD50 test' (for the purposes of Category 6 - see table below) is defined as 'the animal research procedure in which any material or substance is administered to animals for the purpose of determining the concentration or dose of the material or substance which will achieve any predetermined death rate'.

2. Categorisation of teaching, extension and research uses of animals

All animal use activities covered by a standing operating procedure (SOP) have been allocated to a category to indicate the activity and impact on animals.

The categories are set out in the table shown below.

Categorisation of teaching, extension and research use of animals

APPROVAL CATEGORY	TYPE OF PROJECT	TYPE OF PROCEDURE
1	Non-research	Normal husbandry procedures
2	Teaching and extension activity with low impact on animals	Demonstration of vaccination footparing, oral-dosing
3	Teaching and extension activity with greater impact on animals	Demonstration of mulesing, livestock castration, dehorning, AI schools, pregnancy testing, euthanasia.
4	Research with limited impact.	Designed experiments using normal husbandry practices
5	Research with moderate-severe animal impact.	Repetitive techniques which are not normal husbandry practices; e.g. blood collection, fistulae or original and infrequently used techniques not covered by SOP.
6	Activities with severe animal welfare implications	LD50 tests restricted under the Animal Research Act. Approval only by the Minister.

 

SOPs have been approved for commonly used husbandry and research activities. The use of SOPs does not allow AEC consideration to be bypassed, but will result in reduced paperwork. The legislation still requires AECs to consider and approve all educational and research activities involving animals and to monitor their conduct.

An alternative procedure to that set out in an SOP may be considered in an application to an AEC but it must be fully described and justified in the application.

SOPs are regularly reviewed. Suggestions for amendments should be submitted to the Emergencies and Animal Welfare Unit. Final approval for amendments must be given by a meeting of the Chairs of the Industry & Investment NSW AECs.

3. AEC approval process

An AEC considering an application to carry out a research or educational activity must consider all the factors set out in the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes. Applications for approval for activities in Categories 4 and 5 must be made on the protocol form provided by the supervising AEC. The Industry & Investment NSW AECs are based at the Elizabeth Macarthur Agricultural Institute, the Orange Agricultural Institute, the Port Stephens Fisheries Centre (Fish research), and the West Pennant Hills Research and Development Office (Forestry research). The areas to be considered in an application are detailed below.

3.1 Aim and justification of project

What is the objective of the project?

Why is the procedure necessary?

For activities in Categories 2 and 3, the objective is to demonstrate husbandry procedures on farm, at field days or in agricultural colleges. Demonstrations and teaching activities of this kind are necessary to increase the competence of farmers and others who will perform these procedures on a routine basis. Ultimately, it will be in animals' best interests to have competent people performing these procedures.

In the case of original and applied research, the aim and justification are not amenable to standardisation and therefore must be spelt out in individual protocols (Categories 4 and 5). Examples are increased production, identification of a toxin, development of a parasite control regime.

3.2 Justification for animal use

Why must animals be used?

For activities in Categories 2 and 3, where animal use is for an approved educational objective, the need to use animals is recognised because there is no alternative to 'hands on' experience with live animals if the procedure is to be conducted competently in the future. Where alternatives to live animals are available, they must be used for early training to ensure that students/farmers have appropriate skills and knowledge before attempting a procedure on live animals. An example is the use of abattoir specimens and videos.

For original or applied research or diagnostics (Categories 4 & 5), justification for animal use cannot be standardised and must be spelt out in individual protocols.

3.3 Description of procedure and its impact on the animal(s)

What is involved in the procedure?

What effect will this have on the animal(s)?

How will animals be monitored?

How many times will the procedure be carried out on one animal?

Under what circumstances can the animal be used again for the same or another procedure?

These details constitute the bulk of the SOPs because they can be predicted and standardised for routine procedures. In cases where no SOP exists, these details must be covered in a detailed proposal (Category 5).

3.4 Housing and holding

Under what conditions will the animals be held?

What impact will this have?

All commercial livestock species held by Industry & Investment NSW are cared for in accordance with the requirements of the relevant Primary Industries Standing Committee (PISC) Model Code of Practice. Animals used for activities in Categories 2 and 3 will be held under these conditions.

Protocols for activities in Categories 4 and 5 must include housing and holding details, if these will differ from the standard set in the Model Codes or if the nature of the procedure to be conducted is such that a higher standard of care would be appropriate.

3.5 Competence of researcher/teacher

The AEC must be assured of the competence of the person conducting the procedure.  Required levels of competence are spelt out in each SOP and must be detailed in individual protocols for projects in Categories 4 and 5.

For activities in Category 2, the teacher/demonstrator must have competence to conduct the procedure as spelt out in the SOP.

For activities in Category 3, individuals must apply to their local AEC which will determine their competence to carry out specific SOPs.

All teachers and researchers must also be aware of their obligations under other Acts such as the Prevention of Cruelty to Animals Act 1979, the Stock Diseases Act 1923, the Stock Medicines Act 1989, the Poisons and Therapeutic Goods Act 1966, the Veterinary Practice Act 2003, and the Occupational Health and Safety Act 2000.

3.6 Monitoring by AEC

AECs must monitor the progress of research, testing and teaching activities by whichever means they deem appropriate, including site inspections and written or verbal progress reports.

An annual return to the AEC is the minimum reporting required. The AEC may require other information, for example, monitoring procedures.

Any incidents in any activities should be reported as soon as practicable to the supervising AEC.

 

See SOPS for specific animals and procedures.