monitoring program for the scientific use code · meeting the goals set out in the code’...

Queensland the Smart State

To monitor compliance with the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes under the requirements of the Animal Care and Protection Act 2001

Monitoring program for the Scientific

Use Code


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CONTENTS

BULLET POINT SUMMARY............................................................................................................................. 3

DETAILS OF MONITORING PROGRAM FOR SCIENTIFIC PURPOSES ...................................................... 4

INTRODUCTION ............................................................................................................................................... 4

SCOPE OF MONITORING PROGRAM............................................................................................................ 4

PRIORITY OF AUDITS ..................................................................................................................................... 5

BASIS FOR MONITORING MODEL................................................................................................................. 5

FEES.................................................................................................................................................................. 5

SERVICE DELIVERY........................................................................................................................................ 5

SKILLS REQUIRED FOR AUTHORISED OFFICERS..................................................................................... 5

POWERS OF AUTHORISED OFFICERS......................................................................................................... 6

AUDIT FREQUENCY ........................................................................................................................................ 6

SCOPE OF AUDIT ............................................................................................................................................ 6

COMMERCIAL-IN-CONFIDENCE ISSUES...................................................................................................... 7

INDEMNITY AND PUBLIC LIABILITY ............................................................................................................. 7

AUDIT POLICY ................................................................................................................................................. 7

AUDIT TEAM..................................................................................................................................................... 8

AUDIT PROCESS ............................................................................................................................................. 8

AUDIT PROCEDURE........................................................................................................................................ 9

RENEWAL OF REGISTRATION .................................................................................................................... 12

COMPLAINTS ABOUT SCIENTIFIC USE ACTIVITIES................................................................................. 12

GRIEVANCES OR COMPLAINTS ABOUT THE AUDIT PROCESS OR RECOMMENDATIONS ............... 12

DISCLOSURE OF REPORTS......................................................................................................................... 12

APPENDIX 1 – EXTRACT FROM NHMRC 7TH

EDITION OF SCIENTIFIC USE CODE, EXTERNAL

REVIEWS ........................................................................................................................................................ 13

APPENDIX 2 - POWERS OF AUTHORISED OFFICERS (AS DEFINED IN THE ACT) ............................... 16

APPENDIX 3 – NSW AGRICULTURE CHECKLIST...................................................................................... 20

APPENDIX 4 – CHECKLIST FOR AUDIT OF AEC ....................................................................................... 23

APPENDIX 5 – CHECKLIST FOR AUDIT OF AN APPROVED ACTIVITY................................................... 27

APPENDIX 6 –ANIMAL FACILITY INSPECTION CHECKLIST .................................................................... 31


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Bullet point summary

Under the Animal Care and Protection Act 2001 (the Act), all users of animals for scientific

purposes and teaching must register with the Department of Primary Industries and Fisheries

(DPI&F) and have their animal use activities approved by an Animal Ethics Committee (AEC).

Registration is effective for a three-year period.

Under the Act also, all use of animals for scientific purposes including teaching in Queensland

must comply with the Australian Code of Practice for the Care and Use of Animals for Scientific

Purposes (the Code).

Compliance with the Code ensures animals used in science and teaching are treated humanely

and that their use is justified.

The Act provides for the DPI&F to develop a monitoring program for Code compliance. The

monitoring program is supported by national animal welfare advisory bodies, animal welfare

groups and the National Health and Medical Research Council (NHMRC).

The monitoring program is based on triennial audits of registrants and their AECs.

The DPI&F employs specially trained Authorised Officers to carry out audits of registrants and

their AECs. Independent external AEC members with an interest in animal welfare assist the

Authorised Officers in the audits.

Authorised Officers have special powers of entry and limited powers of enforcement.

Registrants will be given notice of audits, however there is provision for unannounced audits in

certain circumstances. In all cases, DPI&F staff will report to the office or administration

building to be accompanied by an institutional representative during the site inspection.

Corrective action is required for non-compliance with Code requirements and if necessary

recommendations are made for improvements in standards.

The results of the audits are confidential with only the names of registrants and dates of audits

disclosed to the public.

The results of the audit will be taken into account when assessing whether a registrant should

be re-registered for a further three-year period and conditions may be placed on re-registration

based on the audit.

There is no charge for the audits.

The audits are separate from any internal reviews carried out by institutions or funding bodies.

However the monitoring program satisfies the requirements of the NHMRC for external review

as per the Appendix 1 in the 7th edition of the Code.


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Details of monitoring program for scientific purposes

Introduction

To ensure compliance with the Australian Code of Practice for the Care and Use of Animals for

Scientific Purposes (the Code), the Animal Care and Protection Act 2001 (the Act) provides for the

development of a monitoring (audit/review) program. The monitoring program is detailed in

Chapter five of the Act and applies to all use of animals for science including teaching in

Queensland.

The purposes of the monitoring program are to:

Ensure compliance with the Code by all users of animals for scientific purposes in

Queensland

Prevent or minimise animal suffering, and

Promote standards of animal care.

The Department of Primary Industries and Fisheries (DPI&F) is committed to the spirit of the

Australian Animal Welfare Strategy to introduce a monitoring program that is consistent with other

states. This also accords with the policies of the National Health and Medical Research Council

(NHMRC) that facilitates the development of the Code. The NHMRC has recommended that

institutions and their Animal Ethics Committees (AECs) undergo a formal external triennial review

(audit) ‘to assist institutions in assessing whether the processes which they have established are

meeting the goals set out in the Code’ (Appendix 1 NHMRC 7th edition of the Code).

The monitoring program is intended to provide transparency and assure the community that the

care and use of animals for scientific purposes is accountable, open and responsible, and is

undertaken in an ethical and humane manner. An independent monitoring and auditing system is

essential to comply with the Queensland Government’s regulatory responsibilities and maintain the

credibility of the animal ethics system in Queensland.

The Act allows for the appointment of Authorised Officers (AOs) to monitor Code compliance and

for the DPI&F Chief Executive to make a suitable monitoring program. Under the Act, AOs are

given special powers of entry and other monitoring powers including limited powers of

enforcement.

The Animal Welfare Unit (AWU) of DPI&F, is the Queensland government agency that administers

the Act and has the task of maintaining the monitoring program.

Scope of monitoring program

The monitoring program focuses on auditing AECs and registrants located in Queensland and

scientific work that occurs within Queensland. AECs located interstate but who sanction work in

Queensland are monitored by the relevant government agency in the other state under a mutual

recognition agreement. However the DPI&F reserves the right for Authorised Officers to travel

interstate to audit registrants and their AECs if necessary. Activities approved by interstate

committees but undertaken in Queensland will be selectively audited by the DPI&F.


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Priority of audits

Where practicable, audits are conducted based on order of registration. However scheduling of

audits is flexible and dependent on the timing of AEC meetings, availability of key staff and dates

of animal use activities. Audits may be brought forward if the DPI&F has concerns about a

registrant or AEC or when there is a bona fide complaint received by DPI&F relating to the

registrant, an AEC or an activity.

Basis for monitoring model

The philosophy of the monitoring program is one of education and collaboration to achieve code

compliance. The DPI&F aims to encourage registrants to maintain and upgrade standards so that

they address community concerns about the use of animals in science and teaching. However

disciplinary action or prosecution will be invoked where there are significant breaches of the Act or

the Code and a failure to address corrective action.

Fees

Registrants and their AECs are not charged for audits or follow-up visits by DPI&F staff.

Service Delivery

Under the Act, the DPI&F Chief Executive appoints individuals that have the necessary experience

and have completed an approved training program. They must be public servants or belong to a

class of other individuals declared in a regulation. Authorised Officers may also be appointed as

Inspectors under the Act.

DPI&F uses independent non-government community AEC members with an interest in animal

welfare to assist the AOs carry out the audits. This improves transparency and provides an

independent animal welfare perspective to the audits. These community members are

appropriately remunerated.

Skills required for Authorised Officers

Authorised Officers are required to monitor Code compliance as well as promote standards of care

for animals and educate users regarding animal ethics issues. AOs require a range of skills and

must be technically competent, have satisfactory character and reputation and the ability to remain

impartial and independent when conducting audits. AOs have the skills and specialist knowledge

to execute their regulatory powers appropriately. Knowledge and skills are required in the

following areas:

1. Technical knowledge of use of animals for scientific purposes.

2. Legal knowledge of the requirements of the Act and the Code as they apply to scientific

animal use, including the proper exercise of powers of AOs.

3. Communication skills to liaise with registrants, carry out audits and investigations,

recommend corrective action, educate users and follow up on non-compliance.

4. Auditing skills. AOs require experience or training in audit techniques, according to the

guidelines of the ISO19011 standard ‘Guidelines for Management Systems Auditing’.


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Powers of Authorised Officers

AOs have limited but sufficient powers under the Act to carry out the monitoring program. It is

intended that AOs work closely with registrants to encourage voluntary compliance and that

exercise of powers is not generally required. Authorised Officers carry and display identification

cards and have power to enter premises either with consent or without consent if 48 hours notice is

given. When carrying out their duties under the monitoring program, AOs always report to the main

office or administration centre of a facility to announce the purpose of their visit and satisfy

quarantine or access requirements. Authorised Officers and community AEC members assisting

with audits are required to have current suitability cards for child related employment (blue cards)

issued by the Commission for Children and Young People.

If required, an Authorised Officer gains additional powers if the Authorised Officer is entering or

has entered a place or vehicle as defined under the Act. AOs can search a premises, open pens

and cages, inspect, copy and take records relating to animal use, take photographs or videos of

premises and animals, identify animals and take samples, and issue and monitor animal welfare

directions. There are offences under the Act relating to failure to assist Authorised Officers in the

exercise of their powers.

For a detailed summary of AO’s legislative powers under the Act, refer to Appendix 2 ‘Powers of

Authorised Officers’.

Audit frequency

The aim of the program is to audit all registrants and their AECs once every three years. At the

end of the initial round of audits, a review will be undertaken of the effectiveness of the monitoring

program that will include consultation with all stakeholders.

Scope of audit

The aim of the audit is to assist registrants comply with the requirements of the Code and ensure

high standards of animal welfare are maintained for all animals used for scientific purposes. A key

component is to encourage a system of self-regulation and self-assessment for the registrants and

the AECs. The scope of each audit depends on the corporate identity of the registrant.

Registrants fall broadly into the following groups:

1. Institutional registrants with an AEC, permanent animal facilities and field sites (eg government

institutions, universities, hospitals).

2. Schools/colleges without an on-site AEC but with permanent facilities and field sites.

3. Non-institutional registrants without an AEC but with permanent facilities (eg manufacturers of

veterinary products, animal refuges, theme parks).

4. Individuals and small corporations and interstate corporations with field sites only (eg private

veterinarians, environmental consultants, agricultural consultants).

The intent is to audit the AEC, permanent facilities and field sites if appropriate.


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Audits are designed to ensure that:

the AEC is operating effectively within the requirements of the Code

AEC processes are fair and transparent to all involved

there is effective communication between the AEC and animal users and the AEC and

senior management of institutions

the AEC is a committee of standing within the institution

the AEC is receiving necessary support from the institution to meet its responsibilities

the involvement of external members in AECs is actively supported and facilitated

Investigators are complying with the requirements of the Code as it applies to their animal

use activities

there are effective strategies to promote and monitor the implementation of the 3Rs of

replacement, reduction and refinement within the institution

there is effective monitoring of the welfare of animals

any facilities used to house animals are managed to achieve high standards of animal

welfare, and

facilities are managed and staffed to achieve high standards of animal welfare

Commercial-in-confidence issues

The audit team declares any potential conflict of interest before the audit and treats commercial-in-

confidence information gained during the audit as confidential and does not disclose this

information to third parties without the permission of the registrant or under legal process.

Indemnity and Public Liability

Members of the audit team are not personally civilly liable for an act done or omission made

honestly and without negligence under the Act. However any liability found against one of these

individuals is instead attached to the State of Queensland.

DPI&F accepts no responsibility for personal liability for other institutional audit team members

assisting with audits. It is expected that institutional staff involved in the audits are covered by the

personal liability policy of the relevant institution.

Audit policy

The Act encourages voluntary compliance and self-regulation and the audit team works with the

registrants to help them comply and maintain high standards of animal care. The audits are not

intended to catch people out, rather they encourage an educative approach to maintain standards

and implement the 3Rs. Institutions will be encouraged to implement an internal review process so

that they achieve a high level of compliance. The regulatory function, while important, is not to be

the primary focus of the audits and in most cases legal action for breaches of the Code or Act are


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only considered where there have been significant breaches and it is considered in the public

good.

The audit team meet with as many relevant staff as possible, including Chief Investigators and

animal house staff.

Audits are conducted triennially and on new registrants within 12 months of registration. All audits

are scheduled in advance and the registrants given notice, however the monitoring program allows

for unannounced or short notice audits where there are complaints or concerns relating to animal

use activities or credible reports of non-compliance with legislative requirements. In all cases, the

auditors will ensure they are accompanied by institutional staff when inspecting premises.

Audit team

Audits are carried out by a DPI&F AO assisted by an external animal welfare representative from

an independent AEC not aligned with the registrant or the DPI&F. The institution’s animal welfare

or ethics officer, the animal house or farm manager, or the veterinary officer in charge of animal

welfare/ethics assist the audit team where the registrant is a large organisation, eg a university or

government agency. The person in charge of the animals should always be present during the

audit.

Audit process

The procedures follow the NHMRC guidelines ‘External review of the operation of animal ethics

committees’ contained in the 7th edition of the Code (Appendix 1).

Audit checklists are used to assist the audit team cover all aspects of the animal ethics system.

(Appendix 3). The following aspects are checked:

1. AEC procedures: Audit team checks membership of the AEC, terms of reference, quorum,

meeting procedures, consensus decision making, record keeping and paper trail, register of

projects, frequency of meetings, frequency and scope of site inspections, reports,

recommendations to institution, monitoring of animal care and use, and implementation of the

3Rs. A checklist used for auditing the AEC is attached as Appendix 4.

2. Audit of individual approved projects: Selected approved projects are audited in detail to

check record keeping and monitoring of animals, and that the project is carried out according to

the conditions of the AEC approval. The institution is given prior notice of which projects are to

be audited so that where possible, the audit team can interview the chief investigator on-site to

discuss the project and the paper trail. The audit team checks that there is appropriate

supervision of animals by trained personnel, and that consideration is given to the wellbeing of

the experimental animals, housing and husbandry and animal identification (Appendix 5).

3. Inspection of general animal facilities: An inspection of the physical facilities to house

animals is carried out to determine compliance with the Code as well as the relevant code of

practice for the particular species. Central to this is an evaluation of the wellbeing of the

experimental and/or breeding animals (Appendix 6).

4. Inspection of field sites: Where the registrant has no permanent animal facility, a field

inspection is carried out on a selected project where practicable. The DPI&F liaises with

registrants carrying out field activities to arrange a suitable activity to audit, which may involve


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out-of-hours inspections. Field inspections focus on site animal holding and handling facilities,

trapping techniques, protection from predators, release or relocation procedures, and provision

of food, shade and shelter where appropriate.

The time taken for audits depends on the size of the institution, the level of animal use activity, and

whether there is an AEC operating at the institution. A small facility may be audited in half a day

while a large university may require a few days. The DPI&F works with registrants to minimise

disruption to their normal activities and where possible schedule audits to avoid peak times, eg

exam periods at educational institutions.

Audit procedure

Audits are conducted in three phases. The first phase is to gather and review essential information

and documents from the registrant. The second is to carry out the audit and site inspection and

the third is to make recommendations, submit a written report and follow-up on corrective action if

necessary.

1. Pre-audit notice and request for documentation

The registrant is sent a written notice, at least one month before the audit with an

information package for staff, investigators and AEC members about scope of the audit and

process. The information package indicates the criteria for the audits and encourages staff

and AEC members to raise any issues of concern or ask questions of the audit team. The

DPI&F requests the AEC minutes for the previous 12 months, the annual report of the AEC

to the institution (if applicable) and a list of approved activities. If required by the institute

or registrant, a confidentiality agreement for the AO and external AEC member is also sent

with this correspondence, to be signed and returned prior to the audit.

The DPI&F will liaise with the registrant regarding quarantine procedures for site

inspections and if appropriate, the registrant will advise the DPI&F whether there are any

restrictions on visiting other sites prior to the audit. DPI&F will work with registrants to

develop audit schedules and procedures to comply with any quarantine requirements.

The DPI&F team reviews the minutes and highlights any issues they wish to discuss with

the AEC or investigators during the audit.

The AO liaises with the registrant (2 weeks prior to audit) to agree on which approved

activity will be subject to an in-depth audit (audit of paper trial, monitoring records,

inspection of animals and interview with investigator).

The DPI&F requests copies of all paperwork for the AEC meeting (agenda, applications,

modifications, correspondence etc) plus a copy of the approved project identified for the

detailed audit, at least 5 working days before the audit.

2. Audit and site inspection. On the day of the audit, the audit team will:

Report to the office or administration section of the institution to introduce themselves and

arrange to be accompanied by the appropriate staff.


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Meet with representatives of the institution to introduce team members and discuss the

program and scope of audit.

Audit AEC records and database. This will include reviewing the list of approved projects,

filing system for minutes of meetings, applications and approvals, modifications, annual

review and completion reports, and the AEC’s annual report to the Institution. The audit

team may seek clarification on issues raised in the minutes of the previous 12 months and

inspect paperwork relevant to those issues.

Attend AEC meeting as observers. The audit team attends the regular AEC meeting and

gives a brief introduction to the members of the AEC about the aims and scope of the audit.

They seek permission from the chairperson to ask questions about applications and

contribute to discussion rather than be silent observers, however they do not contribute to

the decisions of the AEC. The audit team checks that the AEC carries out its activities in

accordance with Code requirements and that all members are involved in the consensus

process. Following the meeting, the audit team discusses issues arising from the audit and

seeks feedback and questions from AEC members about the audit and the overall

compliance process.

Carry out a site inspection of animal holding areas and animal facilities where approved

activities are carried out. The audit team inspects general standards of care and husbandry

of experimental animals, housing, animal identification, monitoring and treatment records,

and housekeeping. A key aspect of the site inspection is to talk to animal house managers,

animal care staff and investigators about their work, and discuss concerns or areas for

possible improvement.

Audit nominated specific project, interview investigator and check paper trail. Where

possible an approved project is subject to a detailed audit to gain an understanding of the

entire animal ethics system from the initial application through to the monitoring records

and reports to the AEC. The audit team has perused the application prior to the audit and

will have an opportunity to talk to the investigator on site and inspect the animals and

records for the activity.

Conduct exit meeting with senior person, AEC chairperson and animal welfare officer and

give and receive preliminary feedback. This meeting enables the audit team to highlight

commendations observed during the audit. Examples of commendations would be

innovative animal ethics training programs for staff or students, efforts to improve the

implementation of the 3Rs or re-designing holding areas to provide environmental

enrichment to experimental animals. The audit team solicits feedback from the institution

on the audit process, the overall animal ethics system and identifies common issues where

institutions may need assistance with standards or compliance. If there are serious

problems or non-compliance with the Act or the Code identified during the audit, these are

raised with the senior officer at the exit meeting.

3. Report and recommendations

Following each audit, the AO sends a report to the registrant within two weeks of the audit and

a copy to the chairperson of the nominated AEC. If the registrant is a corporation, a copy is


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also sent to the chief executive officer of the organisation or other officers nominated by the

registrant.

The report will give details of the audit, commendations, recommendations for improvement,

any non-compliance detected and recommended corrective action.

The audits are intended to be facilitative and educative, however corrective action is required

for non-compliance with the compulsory requirements of the Code.

The DPI&F liaises with the registrant and the chairperson of the AEC to negotiate achievable

time frames for any corrective action recommended by the report. Timeframes for corrective

action are dependent on the severity of the non-compliance and the risk to the animals.

Breaches of the Code receive a high priority and corrective action is mandatory. Where

mandatory corrective action is required, the DPI&F requires evidence that the actions have

been completed and may carry out follow-up site inspections.

Non-compliance is classified as follows:

Major: Major non-compliance involves a breach of the Code or a situation where animal

welfare is severely compromised and there is an urgent need to alleviate pain and suffering.

They require corrective action to be implemented urgently. Examples could be an activity

proceeding without ethics approval or an investigator not abiding by conditions of approval or

carrying out invasive procedures without analgesia or anaesthesia or other procedures that are

not covered by the approval.

Secondary: Secondary non-compliance may constitute a breach of the Code and could

compromise the welfare of the animals or the philosophy of the ethics system and

encouragement of the three Rs. They require corrective action to be implemented in a

reasonable time frame, negotiated with the institution based on the degree of risk. Examples

are housing that does not comply with industry codes of practice or NHMRC guidelines, or

procedures carried out on animals when there is evidence of a validated less invasive or non-

animal alternative.

Minor: Minor non-compliance does not constitute a breach of the Code but still requires

mandatory corrective action. Examples are failure of investigators to provide annual progress

reports on approved activities, or the need to alter the ethics application form to satisfy the

Code requirements.

The report may also make recommendations intended to help the institution raise standards of

animal care and management or streamline the animal ethics system and effectiveness of the

AEC. The recommendations are not mandatory, but the DPI&F will discuss ways they can be

achieved and look for evidence of implementation of the recommendations during subsequent

audits.

Examples of recommendations are suggestions for minor upgrades of animal housing or

providing improved environmental enrichment to caged laboratory animals.


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Renewal of Registration

The results of the audit are taken into account when assessing whether a registrant should be re-

registered for a further three-year period. The Chief Executive may also impose conditions on a

registrant before the registration can be renewed.

The DPI&F makes every effort to assist registrants with the compliance process and allow

sufficient time for corrective action to be implemented. However where there is continued non-

compliance or blatant disregard for the requirements of the Code and the Act, there are provisions

in the Act for the Chief Executive to amend, suspend or cancel registration.

Complaints about scientific use activities

Complaints received by DPI&F or the RSPCA relating to use of animals for scientific purposes will

be investigated by an inspector under the Act. Where the complaint relates to an approved

activity, the inspector will generally investigate the complaint in conjunction with the chair of the

AEC that is responsible for the activity. The inspector and the AEC chair will determine whether

there has been a breach of the Act or the Code and recommend corrective action where

appropriate.

Grievances or complaints about the audit process or recommendations

Persons or individuals that consider they are aggrieved by the audit process or any conditions

imposed on their registration, can submit a grievance to the Manager, Animal Welfare Unit, DPI&F.

The AWU manager will pass the grievance to the Director-General for consideration according to

the DPI&F standard grievance process.

The Act provides for compensation for cost, damage or loss because of the exercise of powers if it

is just in the circumstances of the particular case.

Disclosure of reports

A record of the audits conducted each financial year are included in the annual report of the Animal

Welfare Unit and published on the DPI&F web site. This record indicates which registrants were

audited and the dates of audit, but does not disclose the addresses of registrants. The audit

reports and recommendations remain confidential, however audit reports are subject to freedom of

information requests.

References:

Chave, Lynette. Audits of animal research institutions – the NSW experience. ANZCCART conference proceedings, October 17-19

2002.


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Appendix 1 – Extract from NHMRC 7th edition of scientific use code, external

reviews

Australian code of practice for the care and use of animals for scientific purposes

Australian code of practice for the care and use of animals for scientific purposes 49

APPENDIX 1

Appendix 1 external review of the operation of institutions and their animal ethics committees

1. Introduction

The Code embodies a system of self-regulation by which each institution must put in place

processes to ensure that the care and use of animals for scientific purposes is undertaken in an

ethical and humane manner. In keeping with the notion of self-regulation, the Code defines areas

of responsibility and sets out the principles that guide these activities to ensure the expected goals

are met. A key component of any institutional process is the AEC which determines whether a

proposed use of animals is justified according to the principles of the Code, and then monitors the

ongoing scientific activities. Importantly, through the membership of the AEC, the Code requires

input from the wider community in the oversight of these activities. Thus, the effective operation of

the AEC in all aspects of its responsibilities is central to ensuring that an institution meets its

responsibilities under the Code.

To assist institutions to assess whether the processes they have established meet the goals set

out in the Code, a formal external review of the operation of their AEC, at least every three years,

is recommended (see 2.1.2). This Appendix is intended as a guide to assist institutions in

structuring this external review to best meet their specific needs and to achieve the desired

outcomes.

Existing government compliance processes carried out under the administration of State and

Territory animal welfare legislation may achieve the outcomes set out in this document. Information

on inspection, review and other compliance processes conducted under these legislations is

available from the relevant government departments.

2. Scope and outcomes of the external review

The aim of the external review is to validate that the welfare of animals used for scientific

purposes, including research and teaching, by an institution is safeguarded in accordance with the

Code.

The primary focus of the external review should be to establish evidence that all scientific and

teaching activities involving the use of animals are adequately justified, that the welfare of those

animals used is given due consideration and that the AEC is effective, taking into account its terms

of reference as set out in the Code.

As a result of these enquiries, the external review should enable the institution to evaluate and, if

necessary, modify processes to ensure it meets its responsibilities under the Code. The external

review may also assist scientific and animal care personnel to identify opportunities to promote

animal welfare.


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The external review process should be educational and provide an opportunity for self-assessment

so that members of the AEC and those at the institution who have responsibilities for animal care

and use, are involved in achieving the desired outcomes.

As a result of the external review, the institution should know that:

the AEC is operating effectively according to the requirements of the Code;

AEC processes are fair and transparent to all involved;

there is effective communication between the AEC and researchers and the AEC and

senior management;

the AEC is a committee of standing within the institution;

the AEC is receiving necessary support to meet its responsibilities;

the involvement of external members in AECs is actively supported and facilitated;

there are effective strategies to promote and monitor the implementation of the 3Rs by the institution;

there is effective monitoring of the welfare of animals; and

any facilities used to house animals are managed to achieve high standards of animal welfare.

3. Conduct of the external review

It is recognised that there are many acceptable models for the conduct of an external review, some

of which are already in place, and the approach taken will vary with particular institutional needs.

To maximise the benefits to the institution, the external review should represent an informed,

broad-based view. Members of the review team must be external to the institution and may include

persons who have relevant and appropriate qualifications or experience such as a knowledge of

animal welfare matters pertaining to research and teaching institutions, a demonstrated interest in

animal welfare or experience in the administration of animal welfare and animal ethics appropriate

to the institution.

The ways in which the review team accesses information and conducts its enquiries will vary but

could include review of documentation, observation of activities and procedures, and discussions

with parties involved. For example, elements of the external review may include:

review of paperwork (for example, the AEC terms of reference, proposals for scientific and teaching

activities, procedures, minutes and reports, previous review reports,

approved standard operating procedures and records of monitoring animal welfare);

attendance at an AEC meeting to view the normal running of the meeting;

inspection of animal teaching and research areas and animal holding facilities; and

discussions with the Chairperson and members of the AEC and scientific and animal care personnel.

The review team may find it helpful to track a particular proposal as a way of understanding how

the processes work in a given institution.

The institution and the review team should establish an agreed timetable and approach for the

conduct of the external review, access to information and confidentiality. The institution should

consider ways in which it can facilitate involvement of personnel in the external review process.


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The review team should report to the Head of the institution, making recommendations to address

any problems identified with the operation of the AEC or with the application of the principles of the

Code.

The institution may consider publishing a summary of the external review report, possibly in an

institutional annual report or web site. The summary report could also be made available to the

relevant regulatory authority and funding bodies of the institution.


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Appendix 2 - Powers of Authorised Officers (as defined in the Act)

(N.B. section references, e.g. s100, refer to sections in the Act.)

(a) Function

The functions of an Authorised Officer are to:

(a) monitor compliance with compulsory code requirements and the scientific use code;

and

(b) promote standards of animal care provided for under codes of practice. (s100)

(b) General Provisions about Powers

An Authorised Officer may exercise a power only for the purpose of a monitoring program.

(s107(2))

(c) Entry to places other than vehicles

An Authorised Officer may enter and stay at a place other than a vehicle if:

(a) its occupier consents to the entry (s108(1)(a)); or

(b) it is a public place and the entry is made when it is open to the public (s108(1)(b));

or

(c) an Authorised Officer has given the occupier of the place at least 48 hours notice of

the proposed entry (s108(1)(c)); or

(d) its occupier has been given an animal welfare direction and the entry is made at a

time or interval stated in the direction to check compliance with the direction.

(s108(1)(d))

For the purpose of asking the occupier of a place for consent to enter an Authorised Officer

may without the occupier’s consent:

(a) enter land around the premises at the place to an extent that it is reasonable to

contact the occupier; or

(b) enter part of the place the officer reasonably considers members of the public

ordinarily are allowed to enter when they wish to contact the occupier. (s108(2))

A notice under paragraph (c) (s108(1)(c)) must state:

(a) the purpose of the entry; and

(b) that an Authorised Officer is permitted under the Act to enter the place without the

person’s consent. (s108(3))

If an Authorised Officer intends to ask an occupier of a place to consent to the officer or

another Authorised Officer entering the place under section 108(1)(a) the Officer must tell

the occupier before asking for the consent:


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(a) the purpose of the entry; and

(b) that the occupier is not required to consent; and

(c) that the officer may, under section 108(1)(c) enter the place by giving at least 48

hours notice of the proposed entry (s109(1), (2)).

If the consent is given, the officer may ask the occupier to sign an acknowledgment of the

consent (s109(3)).

The acknowledgment must state:

(a) the occupier has been told:

(i) the purpose of the entry; and

(ii) that the occupier is not required to consent; and

(b) the purpose of the entry; and

(c) the occupier gives the officer or another Authorised Officer consent to enter the

place and exercise powers under the Act; and

(d) the time and date the consent was given (s109(4)).

If the occupier signs the acknowledgment the officer must promptly give a copy to the

occupier (s109(5)).

If:

(a) an Authorised Officer is intending to enter a place under s108(1)(b), (c) or (d); and

(b) the occupier of the place is present at the place;

(c) before entering the place, the officer must do or make a reasonable attempt to do

the following things:

(i) produce or display their identity cards;

(ii) tell the occupier the purpose of the entry;

(iii) tell the occupier the officer is permitted under the Act to enter the place

without the occupier’s consent (s110).

(d) Power of entry to vehicles

An Authorised Officer may enter and stay in a vehicle if:

(a) the person in control of the vehicle consents to the entry; or

(b) the vehicle is stationery and:


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(i) the officer reasonably suspects the vehicle is being or has recently been

used to transport an animal in connection with the carrying out of a business;

or

(ii) the person in control of the vehicle has been given an animal welfare

direction and the entry is made at a time or interval stated in the direction to

check compliance with the direction. (s111)

If:

(a) an Authorised Officer is intending to enter a vehicle under s111(b); and

(b) a person who is a person in control or an occupier of the vehicle is present at the

vehicle;

(c) before entering the vehicle the officer must do or make a reasonable attempt to do

each of the following things:

(i) comply with section 105 for the person;

(ii) tell the person the purpose of the entry;

(iii) seek the consent of the person to the entry;

(iv) tell the person the officer is permitted under the Act to enter the vehicle

without the person’s consent (s112(1), (2)).

If the person in control of the vehicle is not present at the vehicle, the officer must take

reasonable steps to advice the person or any registered operator of the vehicle of the

officer’s intention to enter the vehicle. However, the officer is not required to take a step

which the officer reasonably believes may frustrate or otherwise hinder the performance of

the officer’s functions or the purpose of the intended entry (s112(3), (4)).

(e) Certain inspectors’ powers apply for entry

An Authorised Officer may gain additional inspector’s powers if the Authorised Officer is

entering or has entered a place or vehicle under the Act. However, if an Authorised Officer

enters a place to ask the occupier’s consent to enter premises, this section applies to the

officer only if the consent is given or the entry is otherwise authorised (s113(1), (2)).

The following provisions apply with necessary changes as if the officer were an inspector

had entered the place under Chapter 6 and were exercising a power under that Chapter:

(a) s134, 135, 168 and 169;

(b) Chapter 6 Part 2 Division 3, other than Section 137(d);

(c) Chapter 6 Part 2 Division 5;

(d) Chapter 6 Part 3 (s113(3)).


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(f) Appointment conditions and limit on powers

An Authorised Officer holds office on any conditions stated in:

(a) the officer’s instrument of appointment; or

(b) a signed notice given to the officer; or

(c) a regulation (s101(1)).

The instrument of appointment, a signed notice given to the officer or a regulation may:

(a) limit the officer’s functions or powers under this or another Act; or

(b) require the officer to give the Chief Executive stated information or a report about

the performance of the officer’s functions or the exercise of the officer’s powers

(s101(2)).

In exercising a power under the Act in relation to a person, an Authorised Officer must:

(a) produce the officer’s identity card for the person’s inspection before exercising the

power; or

(b) have the identity card displayed so it is clearly visible to the person when exercising

the power (s105(1)).

However if it is not practicable to comply the officer must produce the identity card for the

person’s inspection at the first reasonable opportunity. The officer is not required to

produce an identity card if the officer is entering a public place or is entering property

seeking to gain the occupier’s consent to entry (s10).


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Appendix 3 – NSW Agriculture checklist

1. This checklist is designed as a guide only - it may not be appropriate to assess all items on

the list and/or additional items may be assessed. The Australian Code of Practice for the

Care and Use of Animals for Scientific Purposes should also be used as a guide.

2. Animal Ethics Committee

2.1 Membership

2.2 Minutes

2.3 Meeting Procedures

2.3.1 Quorum

2.3.2 Frequency of meeting

2.3.3 Circulation of agendas/other material

2.3.4 Voting

2.3.5 Member participation

2.4 Guidelines/Policies

2.4.1 Animal care/husbandry

2.4.2 Research procedures

2.4.3 Emergency procedures

2.5 Grievance/Complaint Procedures

2.6 Inspections/Monitoring

2.6.1 Type

2.6.2 Frequency

2.6.3 Member participation

2.6.4 Records

2.6.5 Follow-up mechanisms

2.7 Research Applications

2.7.1 Form

2.7.2 Consideration of issues

2.8 Issuing of Authorities


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2.9 Annual Report

2.10 Member support

2.11 Communication

2.11.1 With Executive of institution

2.11.2 With researchers

2.11.3 With animal care staff

2.12 Methods for dealing with non-compliance

3. Animal Care and Monitoring

3.1 Well being of animals

3.1.1 Physical condition

3.1.2 Demeanour

3.2 Routine Care

3.2.1 Food

3.2.2 Water

3.2.3 Cleaning

3.2.4 Methods of monitoring

3.2.5 Identification of animals

3.2.6 Time animals held

3.2.7 Records

3.2.8 Transport

3.2.9 Euthanasia

3.2.10 Emergency procedures

3.2.11 Health - prophylactic measures

3.2.12 Animal Care Staff

3.2.13 Methods of reporting and acting on injury, health or other animal welfare

problems

3.3 Animal Production

3.3.1 Breeding systems


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3.3.2 Breeding records

3.3.3 Productivity

4. Facilities (Buildings/Cages/Pens/Paddocks etc)

4.1 Type

4.2 Construction

4.3 Size

4.4 Lighting

4.5 Ventilation

4.6 Temperature control

4.7 Noise

4.8 Stocking rates

4.9 Bedding

4.10 Environmental enrichment

4.11 Storage Areas

4.12 Waste Disposal

5. Research Protocols/Procedures (specific protocols may be assessed)

5.1 Type

5.2 Monitoring

5.3 Methods of assessing and alleviating pain/discomfort/distress

5.4 Completion of research application

5.5 Adherence to protocol application and conditions of AEC approval


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Appendix 4 – Checklist for audit of AEC

This check list covers the major operational and record keeping functions of the AEC as

determined by the Scientific Use Code

1. Name of Committee:

Date of Meeting attended:

2. Names of Authorised Officer and persons assisting:

3. Membership:

(Fill in the numbers in each Category)

Category A Category B Category C Category D Other

4. Minutes

5. Meeting Procedures

a) Quorum

b) Frequency of meetings

c) Circulation of agendas/other material

d) Voting and consensus

e) Involvement of Cs and Ds

f) Encouragement of 3Rs

6. Operating procedures

a) Terms of reference/written acceptance by members


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b) Confidentiality agreements

c) Record keeping system for paper trail (minutes, applications, amendments,

response to applicants)

d) Library of SOPs or other locally approved protocols

e) Emergency Procedures

f) Executive: composition and powers defined

g) Declaration of conflict of interest

7. Register of applications

a) Record of all activities assessed

b) Annual review of long term activities

c) Activity completion reports

d) Approved modifications to projects

8. Site inspections / monitoring

a) Type and frequency

b) Member participation

c) Record of reports


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d) Follow up mechanisms

9. Application Assessment Process

a) Application Form

b) Debate and consensus

c) Attendance of Investigators

d) Requests for further information

e) Responses to applicants/Authorities/Approval Certificates

10. Animal Ethic’s Committee annual report to institution

11. Member support/training

12. Communication

a) With executive of institution

b) With investigators

c) With animal care staff

13. Grievance/Complaint procedures

Mechanisms for dealing with complaints and grievances or alleged non-compliance with

the Code


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14. Housing and Care of Animals

a) Involvement in planning/policy

b) Recommendations for improvement/corrective action

c) Refinement and environmental enrichment

15. General Comments


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Appendix 5 – Checklist for audit of an approved activity

This checklist covers the major items to be reviewed during site inspections to review specific

animal use activities approved by the AEC to ensure compliance with the conditions of approval

and the Code.

AEC activity number:

Short title of activity:

Chief Investigator:

Location of activity:

Date of inspection:

Names of Authorised Officer and persons assisting:


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Feature Description Check

Lay language Application must be easy to read and understand

Justification Aims and objectives must be clear, concise and animal use justified.

Numbers of animals and experimental design must be justified

Minimisation of pain/distress

Impact on animals

Minimisation of pain/distress must be adequately covered in application

Experience and qualifications of investigators

Competency of investigators/carers/proxies must match declarations

3Rs Application must address Replacement,

Reduction and

Refinement

SOPs Where SOPs are referenced, they should be current, available in AEC library and approved by the AEC

Assessment category Assessment category should reflect minuted deliberations and content of application

Authorisations Applications must have all required signatures and declarations completed

Commencement

/Completion dates

Activity must not start before approval granted and completion date must be observed unless amendment requested and approved


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Paper trail Paper trail for application and all related correspondence must be logical and readily accessible (application, response to applicant, modifications, correspondence, reports, amendment requests, corrective action requests)

Animal Records Records should be available for:

Source of animals

Treatments

Monitoring

Repeat use of animals

Disposal, euthanasia methods

Animal identification Animals must be correctly identified and pens labelled with relevant AEC project number

Procedures used during activity

Procedures must match those approved in application

Monitoring Monitoring must reflect approved application and adequate records kept. Emergency contact numbers must be provided

General health and morbidity

Condition of animals, standards of routine husbandry, absence of extraneous diseases/ parasites

Specific health Pain, use of anaesthetics/analgesics

suffering

surgery/manipulation

special care

check for latent diseases

Feed and water type and quality

quantity

accessibility

Behaviour species specific behavioural requirements

space for free movement and activity

sleeping/privacy

environmental enrichment

Social Contact species segregation

Isolation areas - single housing where appropriate for


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species/purpose of study

minimisation of impact of isolation in social animals

Housing space/crowding

escape potential

removal of excrement

bedding/litter comfortable; absorbent; safe; non-toxic; sterilised if needed; suitable for species

Pregnant animals appropriate nesting materials

Health risks to other animals or staff

Appropriate segregation, withdrawal parameters documented and observed, WHS risks managed

Comments/commendations:


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Appendix 6 – Animal facility inspection checklist

This checklist covers the major items to be reviewed during general site inspections to monitor

compliance with the Code. It may not cover all the varied sites where animals are used, and is

meant as a guide to assist in compiling a report. The use of a digital or video camera is

recommended as a useful aid in recording information for the report to the institution.

Name/Description of animal facility:

Section or animal house:

Inspection Date:

Name of Authorised Officer and other persons carrying out inspection:

Features Check Features Check

Security Quarantine area

Vermin control: birds/insects/rodents

Provision of auxiliary power/alarm systems

Appropriate species separation Environmental control

Air exchange/odour

Air filters/drain filters

Temperature/humidity control

Biting Insect control (mesh etc)

Dust

Overall state of repair – buildings, facilities

Floors; condition, appropriate for species, anti-slip surfaces

Noise/vibration Animal records

Hygiene, housekeeping

cleaning and sanitation regime

Animal manipulation areas – separate euthanasia room/surgery/recovery room

Waste management and disposal

SPF houses – entry/exit procedures, air locks, quarantine procedures

Cages and equipment:

Condition, appropriate to species

Waterers

Labelling/identification

Feed preparation and storage – separate from animals/off floor/ air circulation/vermin proof security

Handling and restraint facilities Potential for injury to animals/operators due to design and/or standard of facilities

SOPs or procedures manual Outdoor holding areas

Fences/yards

Shade/shelter, water, drainage


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Staff attitudes, training and knowledge of animal ethics:

Comments

Animals

Points to consider when conducting an inspection. Where possible, person in charge of animals should be present during inspection.

Feature Description Check

Identification Animals must be identified before allocation to project.

Method should cause least stress: tattoo/neckband/individual tag/electronic/physical mark/or by a label or marking attached to the cage, container, pen, yard or paddock.

Records Source of animals

Breeding records

Treatments

Monitoring

Repeat use of animals

Fate of animals, disposal, euthanasia methods

Chief Investigator Accessible after hours, emergency contacts

General health and morbidity

Condition of animals, standards of routine husbandry, absence of extraneous diseases/ parasites

Specific health Pain, use of anaesthetics/analgesics

suffering

surgery/manipulation

special care

check for latent diseases

Feed type and quality

quantity

accessibility

Behaviour species specific behavioural requirements

space for free movement and activity

sleeping/privacy

environmental enrichment

Social Contact species segregation

Isolation areas - single housing where appropriate for


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species/purpose of study

minimisation of impact of isolation in social animals

Housing space/crowding

population density

escape potential

monitoring

removal of excrement

bedding/litter comfortable; absorbent; safe; non-toxic; sterilised if needed; suitable for species

provision of environmental enrichment

Pregnant animals appropriate nesting materials

Has corrective action been addressed from previous reports?

Additional Comments/Commendations:

monitoring program for the scientific use code · meeting the goals set out in the code’...

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