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Licensing of Scientific Procedures
Contents
Scientific Procedures licences and Animal Ethics Committees
The Scientific Procedures Premises Licence (SPPL)
The Scientific Procedures Fieldwork Licence (SPFL)
Licence holders based outside Victoria
Contacts
Introduction
Organisations or individuals wishing to conduct Scientific Procedures with animals in Victoria must hold a licence issued by the Head of the Victorian Department of Primary Industries that authorises the work. Scientific Procedures may be authorised by a Scientific Procedures Premises Licence or a Scientific Procedures Fieldwork Licence, depending on the type of use of the location where the work will be conducted.
Licences will only be issued to legal entities, i.e. entities able to be prosecuted in Victoria. Legal entities include natural persons and bodies corporate. Bodies corporate include ASIC-registered Australian and international companies, institutions incorporated by statute of an Australian parliament, and associations incorporated under Australian State or Territory incorporation legislation, such as through Consumer Affairs Victoria. An Australian Business Number alone does not indicate body corporate status.
Scientific Procedures licences and Animal Ethics Committees
Applicants for Scientific Procedures licences must have an agreement with a properly constituted and functioning Animal Ethics Committee (AEC) to be nominated to oversee animal use for the licence. The nominated AEC will be listed on the licence and no other AEC may be used. A properly constituted and functioning Animal Ethics Committee is one conforming with the National Health and Medical Research Council Australian Code of practice for the care and use of animals for scientific purposes (external link).
The nominated AEC may be established by the licence holder or be an AEC run by another institution. In either case, responsibility for the conduct of the AEC remains with the licence holder. If the AEC does not operate in a legal manner, the licence holder must alter the AEC practices or cease to use that AEC. If an AEC is no longer used the licence holder must stop operations with animals until a replacement AEC can be found and an application made to the Bureau to have the replacement AEC listed on the licence.
A licence holder wishing to conduct Scientific Procedures must apply for approval for the project to the nominated AEC. An application will consist of a completed form that will provide the Committee with sufficient information to assess whether the potential gain provided by the work is worth the impact on animal welfare. Information requested will include detail and context of the planned procedures, the personnel involved and their levels of training, and animal acquisition, housing and monitoring, as well as implementation of the principles of "the 3 R.s" - i.e. whether:
- Alternatives to animal use have been considered (Replacement)
- Only minimal numbers of animal necessary for the project outcome are planned to be used (Reduction)
- Appropriate pain relief and environments will be provided (Refinement)
Organisations or individuals undertaking activities not approved by an AEC, or under the approval of an improperly constituted or functioning AEC are liable to prosecution.
Further information may be found on the Information on Animal Ethics Committees page.
The Scientific Procedures Premises Licence (SPPL)
Scientific Premises
A Scientific Procedures Premises Licence authorises the use of facilities to be ordinarily used for Scientific Procedures, i.e. "Scientific Premises". Due to this specialised use, Scientific Premises are subject to increased levels of scrutiny of upkeep, maintenance of appropriate environments, and establishment of emergency systems to protect animal welfare. Scientific Premises are listed on the licence and are regularly inspected by the Bureau of Animal Welfare as the licensing authority, as well as by the Animal Ethics Committee.
An entity that uses facilities as Scientific Premises must hold a Scientific Procedures Premises Licence for those premises. In addition, an entity that legally occupies Scientific Premises must hold a SPPL for those facilities if they are not covered by another SPPL, whether or not that entity undertakes Scientific Procedures. Legal occupation refers to the owning or leasing of premises or the holding of premises under formal agreement.
An example of the latter case is where an institution owns diagnostic facilities used for Scientific Procedures by other institutions, although not by the owner. The facilities are only used infrequently by each institution, although cumulatively the use qualifies the facilities as Scientific Premises. Because of the nature of use, none of the users could be held responsible for the premises and would not be required to hold a Scientific Procedures Premises Licence for those facilities (although they would be required to hold a licence to authorise this as "Fieldwork"). The premises-owner therefore would be required to hold a SPPL covering the diagnostic facilities and would be responsible for ensuring that appropriate standards are maintained, even though the owner itself does not conduct Scientific Procedures.
A licence holder may use Scientific Premises under the authority of its licence whether or not it legally occupies those premises. For risk management purposes however, it is strongly recommended that licence holders establish a formal agreement for Scientific Premises use, the agreement setting-out responsibilities and liabilities of the various parties.
Use of locations other than Scientific Premises
A Scientific Procedures Premises Licence may also be used to authorise conduct of Scientific Procedures at locations not used as Scientific Premises and that are not listed on the licence. This use of unlisted locations is termed "Fieldwork" and the procedures, personnel, and location(s) must be agreed to by the nominated Animal Ethics Committee as with the use of Scientific Premises. Standards appropriate to the level of use must be maintained. The licence holder must ensure that the Bureau of Animal Welfare is notified of Fieldwork (Word 44KB) after approval by the AEC and prior to commencement of any Scientific Procedures.
The Licence Nominee
An individual must be nominated to be responsible for procedures under a Scientific Procedures Premises Licence - the "Licence Nominee". The Licence Nominee is the first point of contact for the Bureau of Animal Welfare as the licensing authority, and will be corresponded with on all matters relating to the licence, such as breaches of licence conditions, licence audits, reporting of animal use, and Animal Ethics Committee composition and conduct. This person must hold a position in the licensed institution such that they are familiar with the work being conducted, yet senior enough to be able to effect change where necessary.
Breeding
The Prevention of Cruelty to Animals Act 1986 requires that the breeding of guinea pigs; rats, mice, rabbits other than rats, mice and rabbits bred in their native habitat; and non-human primates (i.e. "Specified Animals") for use in Scientific Procedures be authorised by a licence. The Scientific Procedures Premises Licence may be used to authorise this breeding for use by the licence-holder only, and under AEC approval of procedures, personnel, and premises. The licence does not authorise breeding of Specified Animals for supply to other institutions. If this breeding for supply is undertaken, a Specified Animals Breeding Licence is required. In line with the principle of Reduction however, if the number of Specified Animals approved for use in a project under a SPPL are subsequently found to be in excess of project requirements, these animals may be passed on to other licence holders without the need for a Specified Animals Breeding Licence. It is expected that these numbers will be very small.
Breeding of a new strain or hybrid of a genetically modified animal is considered to be a Scientific Procedure, and must be authorised by a Scientific Procedures Premises Licence.
Other licence conditions
All practices carried-out under the licence must be in compliance with the National Health and Medical Research Council Australian Code of practice for the care and use of animals for scientific purposes (external link), the Victorian Code of practice for the housing and care of laboratory mice, rats, guinea pigs and rabbits, and the Code of practice for the use of animals from municipal pounds in scientific procedures. Full details of the Scientific Procedures Premises Licence conditions may be found under Regulation 92 of the Prevention of Cruelty to Animals Regulations 2008 (PDF 818KB). These conditions will also be listed on the licence. Extensive penalties are provided for under the Act on conviction of natural persons or bodies corporate that breach licence conditions.
Forms
Forms to apply for a licence, or to apply to vary a licence
The Scientific Procedures Fieldwork Licence (SPFL)
A Scientific Procedures Fieldwork Licence authorises the use of premises or locations that are not to be ordinarily used by the licence holder for Scientific Procedures (i.e. that are not to be used as Scientific Premises). Examples might include the use of production animals on farms, the intermittent use of Scientific Premises licensed under a Scientific Procedures Premises Licence held by another institution, or the use of non-captive animals in the wild.
No premises or locations are listed on a SPFL, and this work is termed "Fieldwork". Procedures, personnel, and location(s) must be agreed to by the nominated Animal Ethics Committee and standards appropriate to the level of use must be maintained. The licence holder must ensure that the Bureau of Animal Welfare is notified of Fieldwork (Word 44KB) after approval by the AEC and prior to commencement of any Scientific Procedures.
The Licence Nominee
A person must be nominated to be responsible to the licence holder for procedures under a Scientific Procedures Fieldwork Licence - the "Licence Nominee". The Licence Nominee is the first point of contact for the Bureau of Animal Welfare as the licensing authority, and will be corresponded with on all matters relating to the licence, such as breaches of licence conditions, licence audits, reporting of animal use, and Animal Ethics Committee composition and conduct. This person must hold a position in the licensed institution such that they are familiar with the work being conducted, yet senior enough to be able to effect change where necessary.
Breeding
Breeding of Specified Animals may not be not authorised by a Scientific Procedures Fieldwork Licence.
Other licence conditions
All practices carried-out under the licence must be in compliance with the National Health and Medical Research Council Australian Code of practice for the care and use of animals for scientific purposes (external link), the Victorian Code of practice for the housing and care of laboratory mice, rats, guinea pigs and rabbits, and the Code of practice for the use of animals from municipal pounds in scientific procedures. Full details of the Scientific Procedures Fieldwork Licence conditions may be found under Regulation 95 of the Prevention of Cruelty to Animals Regulations 2008 (PDF 818KB). These conditions will also be listed on the licence. Extensive penalties are provided for under the Act on conviction of natural persons or bodies corporate that breach licence conditions.
Forms
Forms to apply for a licence, or to apply to vary a licence:
Licence holders based outside Victoria
Consideration will be given to applications for a licence to conduct Scientific Procedures in Victoria to from interstate applicants, with decisions made on a case by case basis. Applicants with Licence Nominees and/or Animal Ethics Committees based interstate will need to demonstrate an ability to provide supervision and control of licence activities commensurate with the level of risk to animal welfare.
Additional conditions will be placed on licences using interstate AECs stating that the licence holder must provide on request a copy of any interstate regulatory inspection report on the activities and functioning of a nominated AEC relevant to Scientific Procedures conducted in Victoria
Contacts
For further information regarding the licensing of Scientific Procedures in Victoria, please contact the Bureau of Animal Welfare at animal.welfare@dpi.vic.gov.au or (03) 9217 4425.
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