Inspections
Inspections under the Animal Research Act 1985
Aims
Under the Animal Research Act 1985 (the Act), inspections can be carried out of Accredited Animal Research Establishments, Licensed Animal Suppliers and Animal Research Authority holders by NSW Department of Primary Industries (DPI) veterinary inspectors (Inspectors) appointed under the Act. Section 10 of the Act allows for members of the Animal Research Review Panel (the ARRP) to accompany inspectors during inspections.
The aim of inspections is to determine whether establishments, suppliers and individuals are complying with the legislation (the Act and the Animal Research Regulation 2011), the Australian code for the care and use of animals for scientific purposes 2013 (the Code) and any licence/accreditation conditions to which they are subject.
The range of items assessed may include: the membership, procedures and activities of the Animal Ethics Committee (AEC); animal care procedures; animal research procedures; and the physical facilities for housing and using animals. An evaluation is also typically made of the wellbeing of any animals held.
Routine inspections are typically arranged in advance.
Document review
Inspections typically begin with an examination of documents provided by the establishment, supplier or individual. This can include: lists of current animal research authorities, animal ethics committee records (such as minutes, operating procedures and inspection reports), animal husbandry procedures and institutional policies.
Document review is carried out by a veterinary inspector, potentially with input from members of the ARRP where they are participating in the inspection. Document review is typically conducted prior to a site visit to allow for a general understanding of operations to be obtained and potential problem areas to be identified beforehand.
Inspection of animals and facilities, and meeting with the Animal Ethics Committee
On the day of a site visit, the inspection team will typically observe any animals on site and inspect housing facilities and may also speak to staff and AEC members. Where possible, an AEC meeting is attended to allow the functioning of the AEC to be observed and feedback to be given directly to the AEC.
A meeting is usually held with representatives of the establishment at the end of the inspection to discuss any issues identified. Any serious concerns and/or non-compliances identified will be raised immediately.
Inspection report
As soon as possible after the inspection, a report will be prepared and provided to the licence holder/individual. The report will assess the findings of the inspection against the legislation, the Australian Code and licence/accreditation conditions and will outline any areas of actual or potential non-compliance. The report may also contain recommendations for areas of improvement.
Reports are reviewed by a full meeting of the Panel, and additional recommendations may be provided. The Panel may also elect to commend the institution on any initiatives that go above and beyond baseline compliance requirements.
Response & follow up
Establishments and licence holders will be expected to take action in response to the inspection. Areas of actual and potential non-compliance must be addressed, and recommendations should be considered. An initial written response is typically requested within 6-8 weeks of the report being sent (in order to coincide with the next meeting of the ARRP). However, it will be expected that any severe and/or high-risk areas of non-compliance are addressed promptly following the inspection.
Implementation of recommendations is not mandatory, but the establishment is asked to advise on how it has considered the recommendations. If the recommendations have not been implemented, then the reasons for this should be explained.
Inspectors and the ARRP will follow-up with institutions on areas of non-compliance through reviewing written responses. Additional inspections can also be conducted where indicated.
Inspection frequency
NSW DPI and the Panel prioritise the conduct of routine inspections based on risk. Risk-based compliance is in accordance with the NSW Government’s Quality Regulatory Services Initiative and aligns with best practice in regulation.
Inspections based on risk provide the necessary flexibility for NSW DPI to focus its compliance efforts on high priority/risk activities, particularly those identified in the legislation or the Australian Code as requiring additional scrutiny.
NSW DPI may not inspect every licence holder in a 4-yearly period. Where NSW DPI does not undertake a compliance inspection, institutions must still abide by their obligation under the Australian Code, to ensure that a 4-yearly independent external review is conducted, and this review must be conducted by people who:
- are independent of the institution and the activities conducted on behalf of the institution; and
- have appropriate qualifications and/or experience relevant to the activities of the institution.