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

ID: 
67
Personal Details
Organisation Name: 
Biosecurity Queensland
C. Additional Information
Please identify the best term to describe the Organisation: 
Government Department - State
E. Submission
Types: 
Online Written Submission
Written Submission: 
Specific issues requiring particular consideration
After consultation with stakeholders during the initial phases of this review, specific issues have been identified as requiring particular consideration. Your comment is invited on these issues.
Comment on specific Sections, clauses or sentences of draft revised Code of Practice
Select if you wish to provide comment on specific Section, clauses or sentences within the draft revised Code of Practice.
General Comments
Select if you wish to make general comments about the draft revised Code of Practice.
Specific issues requiring particular consideration
1. Does the document clearly and concisely set out governing principles?: 

Biosecurity Queensland supports the revision of the Australian code of practice for the care and use of animals for scientific purposes (the Code) and the development of a higher level principles based document. The draft document clearly and concisely sets out the governing principles by which all persons involved in the care and use of animals for scientific purposes are required to comply with.

Biosecurity Queensland recommends that consideration be given to ensuring the principles of the 3 R’s (replacement, reduction and refinement) and the requirement to consider the applicability of the 3R’s have greater prominence within Section 1 of the draft Code. This proposed amendment will clearly demonstrate to the Australian and international scientific, teaching and general community that the 3R’s lies at the “heart of the Code”.

2. Are the terms “should’ and “must” used appropriately in the document?: 

Biosecurity Queensland has no issues with respect to the proposed definitions for ‘must” and “should” as given in the draft Code for public consultation. Defining these terms provides greater clarity with respect the requirements and responsibilities of all parties under the Code and will assist institutions, animal ethics committees (AEC) and persons that use animals for scientific purposes to comply with the Code. 

3. Does the document clearly and concisely set out, and correctly attribute, responsibilities of all parties involved?: 

On the whole, the draft Code for public consultation does clearly and concisely set out the responsibilities of all parties involved in the care and use of animals for scientific purposes.

The defining of the terms “must” and “should” and the clear delineation of responsibilities to different parties will greatly assist Biosecurity Queensland officers appointed to conduct reviews of users of animals for scientific purposes in Queensland under Biosecurity Queensland’s Monitoring Program (i.e. the government review). The primary aim of the Monitoring Program is to ensure compliance with the Animal Care and Protection Act 2011 and the Code.  

4. Does the document provide all relevant parties with sufficient practical guidance on the application of principles of Code of Practice in terms of their responsibilities?: 

Generally, the draft Code for public consultation provides all relevant parties with sufficient practical guidance on the application of the principles of the Code of Practice. However Biosecurity Queensland recommends that additional guidance should be provided to Animal Ethics Committee members when considering the cost to the animals to be used and the benefits to be gained from conducting such an activity.

It is noted that cross referencing has been introduced into the draft Code and Biosecurity Queensland supports the inclusion of this feature. Biosecurity Queensland recommends that more cross referencing should be introduced in other sections of the draft Code. For example, any reference to the humane killing of animals should be linked to Section 3.5, pp 51 – 52. 

5. Should the document include specific guidance regarding the responsibilities of Veterinarians and Animal Welfare Officers?: 

Veterinarians play an important but understated role in the care and use of animals for scientific purposes including teaching. Potentially the involvement of veterinarians can cover a wide variety of situations within this context.

It is noted that the draft Code for public consultation includes approximately 26 references to the words “veterinarian” and “veterinary services” across the many different sections of the draft Code.

 Veterinarians can be viewed as a sub-group of the animal carer group and it can be argued that role of the veterinarian is just as important as the roles of the animal carer and facility manager. Apart from the provision of veterinary services and providing input to Animal Ethics Committees as Category A members, the skills of veterinarians can be further utilised in the teaching/ training of investigators in specific veterinary based skills, the verification of the competency of various persons to perform specific veterinary based skills and as part of an external review team. Biosecurity Queensland supports the inclusion of a separate section which outlines the responsibilities of the veterinarian with respect to the care and use of animals for scientific purposes including teaching.

Animal Welfare Officers also play an important role in the use of animals for scientific purposes. The case for the inclusion of guidance about the responsibilities Animal Welfare Officers carries less weight as Animal Welfare Officers are employed in only a limited number of institutions in Australia namely universities and colleges.  The role of Animal Welfare Officer can also vary from institution to institution. At this point in time, Biosecurity Queensland does not support the inclusion of specific guidance regarding Animal Welfare Officers. However this does not preclude the inclusion of specific guidance regarding Animal Welfare Officers in future editions of the Code. 

Biosecurity Queensland endorses clauses 2.1.7 (viii) and 2.1.9 (vi) of the draft Code for public consultation regarding the responsibility of institutions to implement an appropriate veterinary care program.

In addition to these clauses,  Biosecurity Queensland proposes that the draft Code for public consultation should require a higher level of veterinary supervision where anaesthesia and surgery, or other invasive or painful procedures, are performed.  This is because researchers who lack veterinary training may not be best placed to provide appropriate peri-operative care including (most importantly) expert administration of anaesthetic and analgesic regimes.

A system of veterinary “certification, oversight and monitoring” is thus proposed, according to the following principles:

  1. Researchers must be directly assessed and certified as competent to perform specified medical and surgical (or other invasive or painful) procedures by a suitably experienced registered veterinary surgeon, prior to undertaking procedures.
  2. The supervising veterinarian will have the responsibility and authority to ensure all aspects of perioperative care will be appropriately managed. This will include assessing operative technique, anaesthetic and analgesic selection, and postoperative care protocols, prior to commencement.
  3. The supervising veterinarian will provide ongoing oversight and intermittent monitoring of the procedures, and be available to assist in any emergencies or unexpected events.
  4. The frequency and closeness of monitoring should be commensurate with the potential impact of the procedure, so that procedures with high risk of adverse welfare impacts will be more closely supervised by the attending veterinarian.
  5. It is the responsibility of the institution and relevant animal ethics committee to ensure the principles of veterinary certification, oversight and monitoring are implemented.

In the United Kingdom, the addition of clinical veterinary expertise to the research setting has been reported to be beneficial to research animal welfare, contributing significantly to:

  • Better methods of anaesthesia
  • Better recognition of pain and wider employment of analgesia for painful procedures
  • The refinement of surgical procedures and post-operative care of experimental animals (LAVA - The Laboratory Animals Veterinary Association, 2011)

Biosecurity Queensland's proposal for veterinary “certification, oversight and monitoring” aims to balance the objective of effective research outcomes with the objective of minimising unnecessary suffering in sentient animals.

References

Brown MJ, Pearson PT, Tomson FN (1993) Guidelines for animal surgery in research and teaching, Am J Vet Res, Vol  54 (9). This guideline was prepared by AVMA (American Veterinary Medical Association) and ASLAP (American Society of Laboratory Animal Practitioners) and has been adopted by the AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care International).

Voipio HM, Baneux P, Gomez de Segura IA, Hau J and Wolfensohn S (2008), Guidelines for the veterinary care of laboratory animals: report of the FELASA/ECLAM/ESLAV Joint Working Group on Veterinary Care, Laboratory Animals, 42, 1-11

Zurlo J, Bayne K and MacArthur Clark, J (2009) Adequate Veterinary Care for Animals in Research: A Comparison of Guidelines from around the World, ILAR Journal, 50 (1), 85 - 88 

6. As a principles-based document, the impact of the revised Code of Practice may be lost if too much detail is included. Comment is therefore specifically sought on whether there is sufficient balance between principles and detailed guidance.: 

In general, Biosecurity Queensland believes that the revised Code of Practice provides sufficient balance between the key principles and the detailed guidance for all parties responsible for the care of animals being used for scientific purposes including teaching.

However the draft Code for public consultation makes a number of references to persons being competent in a certain role, procedure or activity or persons being supervised by a competent person e.g. clauses 2.1.8 and 2.1.9; p13. The draft Code for public consultation does not define competence nor provide any guidance on the requirements to be deemed competent and to maintain competency. As this is a national Code of Practice it is important that the term, competence, be defined and more guidance provided about what competency entails (including the elements and standards to be met in order to be considered to be competent). 

7. Is there clear connection between the Code of Practice and the NHMRC Guidelines to promote the wellbeing of animals used for scientific purposes: The assessment and alleviation of pain and distress in research animals (2008) (Wellbeing Guidelines)?: 

There is a clear connection between Section 3 of the Code of Practice and the NHMRC Guidelines to promote the wellbeing of animals used for scientific purposes: The assessment and alleviation of pain and distress in research animals (2008) (Wellbeing Guidelines). However further connections/ references to the Wellbeing Guidelines could also be made in other part of the draft Code. For example, Part 2 of the Wellbeing Guidelines has direct relevance to both investigators and animal ethics committees with respect to their responsibilities (clauses 2.3 and 2.4).

It is noted that in clauses 2.4.47 (v) & (vi) (p 38) that references are also made to other NHMRC guidelines for monoclonal antibody production and the NHMRC policy on the care and use of non-human primates for scientific purposes. Biosecurity Queensland recommends that the draft Code for public consultation should make further references to other current relevant guidelines and policies endorsed by the NHMRC, where appropriate.

8. Do you believe the title of this document should be amended to reflect the focus of the Code of Practice on ethical principles and best-practice guidance, and to more clearly indicate the scope of the Code of Practice?: 

Biosecurity Queensland recommends that the title of this document should remain unchanged for the following reasons:

  1. The Australian code of practice for the care and use of animals for scientific purposes is identified under the Section 49 of the Animal Care and Protection Act 2001 (ACPA) and a change in the title of this document would necessitate an amendment to the legislation; 
  2. The current title has been used for at least the past 3 editions of this document while still covering the same breadth of topics as covered in the draft Code for public consultion i.e. the 8th edition; and
  3. Changing the title of the document may cause confusion amongst the scientific and general community with regard to identifying the document. 
9. Is “animal” appropriately defined? Should the definition account for animals at the early stage of their development (i.e. embryonic, fetal and larval forms)? : 

In Queensland, the Animal Care and Protection Act 2001 (ACPA) is the primary piece of legislation for animal welfare and regulating the use of animals for scientific purposes. Section 11 of the ACPA defines an animal as follows:

 (1)              An animal is any of the following –

 (a)                a live member of a vertebrate animal taxon;

 Examples:

  • an amphibian
  • a bird
  • a fish
  • a mammal, other than a human being
  • a reptile

 (b)        a live pre-natal or pre-hatched creature as follows if it is in the last half of gestation or development –

            (i)            a mammalian or reptilian foetus;

            (ii)           an avian, mammalian or reptilian pre-hatched young;

 (c)        a live marsupial young

 (d)       a live invertebrate creature of a species or stage of the life cycle of a species, from the class Cephalopoda or Malacostraca prescribed under a regulation for this paragraph.

  (2)               However a human being or human foetus is not an animal.

 (3)                To remove any doubt, it is declared that the following are not animals –

 (a)                the eggs, spat or spawn of a fish;

 (b)               a pre-natal, larval or pre-hatched creature, other than a creature mentioned in subsection (1) (b) or (c);

 (c)                another immature form of a creature, other than a creature mentioned in subsection (1) (a) to (c).

 Under the ACPA’s definition of animal, the following animals from the class Cephalopoda have been included as part of a regulation:

  •  Octopus;
  •  Squid;
  •  Nautilus; and
  •  Cuttlefish

 At this point in time, there are no animals from the class Malacostraca included in this definition.

 The draft Code’s proposed definition of animal does bring it more in line with the definition of animal as given in the ACPA.

 

10.Comment is sought regarding the proposal for a Category E membership category for an Animal Ethics Committee to be mandatory for institutions that have or maintain animal breeding or holding facilities. How would the proposed changes work for your AEC?: 

There are a number of advantages and disadvantages with respect to this proposed change. One must carefully consider whether there are any overwhelming benefits in bestowing full membership on the Category E members.

On balance, Biosecurity Queensland recommends that the Category E membership category should remain in an advisory capacity to the Animal Ethics Committee rather than be granted full membership because of the following reasons:

  1. It is highly likely that the Category E (“Animal Carer”) members will have a conflict of interest in assessing many of the applications presented for approval because of their direct or indirect involvement in the proposed activity or project;
  2. Category E (“Animal Carer”) members are usually institutional staff and the influence of the Category C and D members in AEC discussions will be further diluted by the inclusion of Category E members; and
  3. Informal feedback from AECs is that most AECs will find it difficult to obtain a quorum for AEC meetings under the present structure and it is highly likely that the inclusion of the Category E member will make this situation even more difficult.     

The second part of this question is not applicable as Biosecurity Queensland does not have responsibility for an AEC. 

11. Should the document include a guide regarding the longest duration of approval granted by an Animal Ethics Committee (AEC) for a project before submission of a new application is required? : 

Biosecurity Queensland agrees that there is a strong argument (particularly with the rapid development of scientific knowledge) for investigators to submit a new application for a continuing project.

 Biosecurity Queensland recommends that a guide regarding the longest duration of approval granted by an AEC for a project before the submission of a new application is required and should be included in the draft Code for public consultation.

Biosecurity Queensland notes that clause 4.5.2 (ii) (p69) of the draft Code for public consultation provides guidance to schools and AECs about considering applications which involve repeating a particular activity. Approval may be granted for a maximum of three years conditional upon an annual report about the activity being provided to the AEC. 

Comment on specific Sections, clauses or sentences of the draft revised Code of Practice
Specific Comments: 
Section 1-Clauses 1.1 to 1.5

Clause 1.3; p5 

The current wording of clause 1.3 is ambiguous as it is difficult to understand how the scientific or educational merit of a proposed activity can be demonstrated prior to the activity being approved and conducted without the activity being conducted previously. It is recommended that this sub-section be reworded to make the intent clearer.

Section 2-Clauses 2.1.1 to 2.1.19

Clause 2.1.7 (viii); p13

The current wording of clause 2.1.7 (viii) requires institutions with an AEC to appoint a veterinary surgeon or person with equivalent qualifications to assist the AEC with ensuring projects proceed in compliance with the Code and AEC decisions. Biosecurity Queensland supports the continued inclusion of this requirement. 

Clause 2.1.9; pp 13 - 14

Biosecurity Queensland supports the requirement for institutions to ensure all persons involved in the care and use of animals are competent or under the direct supervision of a competent person. However the draft Code for public consultation does not define competence nor provide any guidance on the requirements to be deemed competent and to maintain competency. Biosecurity Queensland recommends the following:

  1. The term, competence, be defined in the draft Code for public consultation; and
  2. The development of a guidelines document to provide further guidance to institutions about what competency entails (including the elements and standards to be met in order to be considered to be competent).

 

Section 2-Clauses 2.2.12 to 2.2.25

Clause 2.2.13 (ii); p18: 

This clause deals with a ‘minor modification’ or ‘minor amendment’ to an activity/ project approved by an AEC. Biosecurity Queensland recommends that further guidance in the form of examples should be provided to assist with clarifying what a ‘minor modification’ or ‘minor amendment’ entails. This sentence also makes reference to both  ‘minor modification’ and ‘minor amendment’. It is recommended that the terminology used should be consistent so as to avoid confusion.

Clause 2.2.17; p19

This clause permits AECs to appoint additional members (other than categories A to E) with skills and background of value to the AEC. It should be noted that the appointment of a category E member to an AEC by an institution could be accommodated by use of this clause rather than make their membership mandatory under clause 2.2.15.

 Biosecurity Queensland acknowledges that persons with specialist skills in statistics, bioethics and law could make valuable contributions to an AEC.  Biosecurity Queensland recommends that further guidance regarding invoking this clause is warranted.   

Section 2-Clauses 2.4.39 to 2.4.47

Clause 2.4.47 (iv); p38:

This clause deals with the prolonged restraint or confinement of animals during a project. The clause requires investigators to ensure that restrained or confined animals are regularly assessed by a veterinarian or other qualified person not involved in the project. It is clear from the draft Code for public consultation that during conduct of the activity, the investigator has primary responsibility for the well being of the animals being used. In this case, it would be expected that the investigator be competent in determining when an animal is distressed or not coping with the environment it has been placed in and act appropriately to ensure the well-being of that animal. The AEC is responsible for ensuring any adverse impacts on the animals being used are minimised and they monitor the use of animals in activities.

As animal health and welfare experts, veterinarians can play an important role in ensuring the wellbeing of the animals being used for scientific purposes. Biosecurity Queensland recognises the benefits of having a veterinarian or person with equivalent qualifications perform this role. However Biosecurity Queensland recommends that from an accountability point of view consideration should be given to including this clause as a guideline or best practice principle.

 

Section 2-Clauses 2.5.4 to 2.5.22

Clauses 2.5.21 & 2.5.22; p43

Both clauses 2.5.21 & 2.5.22 deal with occupational/ workplace health and safety issues which should be dealt with by an institution's occupational/ workplace health and safety policy (in accordance with each State and Territories occupational/ workplace health and safety legislation). It could be argued that the clauses lie outside of the direct scope of the draft Code for public consultation. Biosecurity Queensland recommends that consideration be given to the deletion of both clauses from the draft Code for public consultation.  

Section 3-Clauses 3.2.1 to 3.2.12

Clause 3.2.10; p47:

Clauses 3.2.8 to 3.2.11 deal with plans to manage animal well-being by setting humane end-points and intervention points in projects where the animal is predicted to experience pain and/ or distress as a result of a procedure.

Biosecurity Queensland has some concerns with the current wording of clause 3.2.10 as it implies that investigators can modify a plan, which has been developed to manage animal wellbeing, during the course of the activity and without consultation with the AEC. It is assumed that that the AEC would have approved the animal wellbeing management plan as part of approving the investigator's application. If the animal wellbeing management plan requires modification by the investigator then the AEC must be consulted on this issue. This process may necessitate stopping or suspending the activity (depending on the nature of the activity) until such time as a course of action/ alternate plan has been agreed upon. This situation highlights the value of conducting a pilot study.  Biosecurity Queensland recommends that consideration be given to deleting or modifying this clause.

Section 3-Clauses 3.3.1 to 3.3.44

Clause 3.3.11; p48:

This clause deals with the transport of animals by air and compliance with the International Air Transport Association (IATA) regulations. It is recommended that this clause be expanded or another clause added to address the transport of animals by other means such as by land and compliance with the appropriate legislation, regulations and other welfare codes of practice.

Section 3-Clauses 3.4.1 to 3.4.3

Clause 3.4.3; p51

The use of electroimmobilisation for the restraint of animals has been reviewed and its use banned on welfare grounds by several countries and soem Australian States. New Zealand and some Australian States continue to permit its use. In view of the availability of wide variety of other humane methods of restraining an animal, it is recommended that consideration be given to prohibiting the use of electroimmobilisation as a method of restraint in research and teaching activities. If this can't be accommodated then there must be a requirement for the investigator to present to the AEC a compelling argument which justifies its use over other available humane methods of restraint and the safeguards which will be used should the AEC condone its use. 

Section 3-Clauses 3.5.1 to 3.5.11

Clauses 3.5.1 to 3.5.11; pp 51 - 52

Biosecurity Queensland very strongly recommends that all persons tasked with the humane killing of animals used for scientific purposes must be competent in the method of killing they intend to use for a particular animal species and this be included as a new requirement.  

Section 3-Clauses 3.7.1 to 3.7.11

Clause 3.7.10; p54

This clause deals with the use of neuromuscular blocking agents. There have been minimal changes to the wording of this clause compared with same clause in the 7th edition of the Code of Practice (3.3.41; p27).  It is noted that the use of neuromuscular blocking agents with an appropriate surgical procedure that eliminates sensory awareness continues to be permitted.

The use of neuromuscular blocking agents in research using animals has been controversial because these agents abolish some of the signs used to judge the depth of anaesthesia. The animal may appear to be anaesthetised (i.e. unresponsive to painful stimuli) but in fact is unable to respond to the painful stimulus because it is paralysed.

Two international journals, Anesthesiology and Cardiovascular Research have published editorials about the use of neuromuscular blocking agents in animals in research. The editors of Anesthesiology have advised that even if an Institutional Animal Care and Use Committee (IACUC) (the American equivalent to an AEC) approves the use of these agents, the editors retain the right to reject the researcher’s manuscript, if the use of these agents does not meet the journal’s stated principles1. Marsch and Studer (1999) went further and recommended that institutional animal committees adopt the policy of banning these drugs2. Some Australian institutions also have policies prohibiting or restricting the use of these agents.  

Biosecurity Queensland recommends that if there is no compelling evidence for the continued use of neuromuscular blocking agents in research with animals then consideration be given to phasing out the use of these agents. However if there is compelling evidence for their continued use then consideration must be given to further reviewing this clause. The review of this clause must address the following points:

  1. Establishing whether the use of neuromuscular blocking agents in animals with an appropriate surgical procedure that eliminates sensory awareness should be prohibited; and
  2. The development of strict principles for institutions, their AECs and investigators regarding the use of these agents in conjunction with general anaesthesia and the requirements regarding monitoring of animals under this anaesthetic regime.

References

  1. Drummond J.C.; Todd M.M. and Saidman L.J. Use of neuromuscular blocking drugs in scientific investigations involving animal subjects: The benefit of the doubt goes to the animal. Anesthesiology 1996; 85: 697 – 699.
  2. Marsch S.C.U. and Studer W. Guidelines to the use of laboratory animals: what about neuromuscular blocking agents? Cardiovascular Research 1999; 42: 565 – 566.
Section 3-Clauses 3.7.18 to 3.7.26

Clause 3.7.20; p54

Biosecurity Queensland recommends that all surgery performed on an animal must follow aseptic principles, regardless of the fate of the animal at the conclusion of the activity.

Section 4-Clauses 4.3.1 to 4.3.8

Clause 4.3.3 (i); p66

Biosecurity Queensland has concerns with the an AEC associated with an educational institution granting pre-approval (or equivalent) for designated activities of a routine nature and low impact to the wellbeing of the animal. It is acknowledged that AECs approve the use of animals for for various educational activities such as rat and toad dissections but teachers are still required to submit an application for approval. Biosecurity Queensland recommends that the second sentence of clause 4.3.3 (i) be deleted as it creates unnecessary ambiguity about the AEC approval process.

Section 4-Clauses 4.4.6 to 4.4.11

Clause 4.4.9; p68

Biosecurity Queensland is concerned that the current wording of this clause could include activities which have a high welfare impact on the animals (e.g. mulesing, castration, branding, beak trimming, teeth clipping and tail docking). Further this clause does not define terms such as "licensed veterinary facility", "routine procedures" and "routine management" which leaves this exemption open to interpretation.     

Biosecurity Queensland strongly recommends that this exemption should be restricted to the demonstration of routine procedures or observational based activities. 

Section 4-Clauses 4.4.12 to 4.4.17

Clause 4.4.15; p69

Biosecurity Queensland is concerned that competency based training courses involving activities which have a high welfare impact on the animals (e.g. mulesing, castration, branding, beak trimming, teeth clipping and tail docking) may be exempt from AEC scrutiny and approval, if the current wording of this clause is retained.

Biosecurity Queensland is futher concerned that certain aspects of the training of students in veterinary science, veterinary nursing and animal technology would not require prior AEC scrutiny and approval. There are some activities such as rectal palpation, dentistry and artificial insemination  which when carried out by veterinary science students could potentially have a major impact on the welfare of the animals being used.   

This clause does not define terms such as "licensed veterinary facility", "routine procedures", "routine management" and "veterinary clinical management" which leaves this exemption open to interpretation.    

Biosecurity Queensland strongly recommends that this clause be deleted.  

Section 5-Clauses 5.1 to 5.10

Clause 5.8; p71:

This clause deals with the reporting of serious breaches of the Code to the relevant State or Territory regulator. The current wording of this clause implies that there is some discretion in the reporting of serious breaches of the Code to the relevant State or Territory Government authority.

In Queensland the Code is recognised as a compulsory code and compliance with the Code is mandatory. It is incumbent on persons or institutions with knowledge/ evidence of acts which potentially represent a serious breach of the Code to report this matter to the relevant State or Territory Department which regulates the use of animals for scientific purposes. 

Biosecurity Queensland recommends that the words "if appropriate" be deleted from this clause. 

Clause 5.9; p71

As a part of good governance, institutions and organisations should have processes in place to ensure compliance with any legislative requirements and can assist with the management of risk. Biosecurity Queensland recommends that the requirement for an institution to keep a register of any breaches of or non-compliances with the Code should be mandatory as it will provide a demonstrable and auditable method of monitoring and dealing with the Code non-compliances. The establishment and maintenance of a register to record the actions taken with respect to potential breaches of/ non-compliances with the Code would also complement an institution’s complaints process. 

Section 6-Clauses 6.2.1 to 6.2.6

Clause 6.2; p 73

The draft Code contains a number of significant changes with respect to the external review process and implies that outside of the review by State and Territory regulators (the “government review”), the external review will now become an important mechanism of ensuring compliance with the Code.

 It is apparent that the scope and outcomes of the external review need to be broadened to encompass the additional requirements which have been placed on institutions under the draft Code for public consultation.

Section 6-Clauses 6.3.1 to 6.3.8

Clause 6.3; p74

Biosecurity Queensland recommends that a person with auditing experience (preferably with leading audit teams) should also be considered for inclusion as part of the external review team. 

General Comments
General Comments: 

Biosecurity Queensland, a service of the Department of Employment, Economic Development and Innovation,  would like to thank the National Health and Medical Research Council (NHMRC) for the opportunity to make a submission regarding the proposed revision of the Australian code of practice for the care and use of animals for scientific purposes, 7th edition (2004). 

Biosecurity Queensland is responsible for regulating the use of animals for scientific purposes under the Animal Care and Protection Act 2001(ACPA). Under the Animal Care and Protection Act 2001 all users of animals for scientific purposes (including teaching) must register with Biosecurity Queensland; have their animal use activities approved by an Animal Ethics Committee (AEC); and report annually to Biosecurity Queensland on the animals used during the previous calendar year. Users must also comply with the current edition of the Australian code of practice for the care and use of animals for scientific purposes.     

The Australian code of practice for the care and use of animals for scientific purposes is recognised as a compulsory code under ACPA, which means compliance with the code of practice is mandatory.

 Biosecurity Queensland has played an active role in the review process through its involvement with the Code Writing Groups and Code Reference Group as well as encouraging both interested internal and external stakeholders to participate in the review process.

Biosecurity Queensland’s submission to the NHMRC review of the Australian code of practice for the care and use of animals for scientific purposes, 7th edition (2004) is based on the public consultation questions and other specific issues associated with the consultation draft.    

In terms of issues that are not covered in the Code of Practice that you think should be covered in the document, Biosecurity Queensland recommends that the draft Code should include a broad overview of the current animal ethics system in Australia. This inclusion will provide all parties responsible for the care and use of animals for scientific purposes with a greater understanding of the roles; responsibilities and relationships between the different bodies such as the NHMRC; other Australian government departments; State & Territory governments; institutions and a like.

Page reviewed: 1 March, 2013