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Animal Welfare - Senate Select Committee -Reports - Animal experimentation, 1989


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Animal Experimentation

Report by the Senate Select Committee on Animal Welfare

The Parliament of the Commonwealth of Australia

ANIMAL EXPERIMENTATION

Report by the

Senate Select Committee on Animal Welfare

' .

.. '

Australian Government Publishing Service Canberra

© Commonwe alth of Australia 1 989 ISBN 0 644 0 9 621 7

THE PARliAMENT C'F THE 'f.H (.•F

PARLIAMENTARY PAf'ER

No.' 3 9 6 .OF 1989

Ordered to be printed by authortty tSSN 0727-4181

PRINTED BY PIRIE PRINTERS SALES PTY LTD, FYSHWICK, A. C.T. 2609

MEMBERSHIP OF THE COMMITTEE

Members

Senato r A.R. Devlin (Tasmania>, Chairman

Senator D. Brownhill (New South Wales> *

Senat o r P.H. Calvert (Tasmania> ***

Senator B. Cooney *

Senato r J. Morris ***

Senator N.K. Sanders (Tasmania) **

*

** ***

From 1 July 1985 From 21 August 1985 From 24 September 1987

Former Members

Senator Jack Evans -<7 December 1983 - 30 June 1985)

Senator J.M. Hearn

***

Senator the Hon. D.B. Scott (New South Wales> -<7 December 1983 - 30 June 1985>

Senator J.R. Siddons -<1 July 1985 - 21 August 1985>

Senator G. Georges -<7 December 1983 - 5 June 1987>

Secretary

P . Barsdell The Senate Parliament House Canberra

iii

CONTENTS

Me mbership of the Committee

List of Tables Abbreviations Used in the Report

List of Recommendations

CHAPTER 1 - INTRODUCTION

Appointment of the Committee and its Terms of Reference Conduct of the Inquiry Nomenclature Animal Experimentation Debate Acknowledgements

CHAPTER 2 - ANIMAL EXPERIMENTATION IN AUSTRALIA

Introduction Victoria Western Australia Universities

CSIRO Conclusions

CHAPTER 3 - THE MORAL STATUS OF ANIMALS AND THE ETHICS OF ANIMAL EXPERIMENTATION

Introduction Historical Perspective Utilitarianism and Suffering Difficulties with Utilitarianism Animal Rights Animal Freedom and Other Moral Claims Animals and Equality

Conclusions

CHAPTER 4 - ANIMAL PAIN AND DISTRESS

Definitions Scientific Attitudes to Animal Pain Difficulties in the Assessment of Animal Pain and Distress

v

iii

xi

xiii XV

1

1

2

3

4

7

9

9

9

13 16 18 20

23

23 24 25 28 31 33 39 41

43

43 47

49

Animal Pain Assessment Pain Classification System Pain Re lief in Laboratory Animals Pain in Codes of Practice

CHAPTER 5 - THE USE OF ANIMALS IN BIOMEDICAL RESEARCH

Introduction Value of Biomedical Research Use of Animals in Basic Research Repetition of Experiments Alternatives

Tissue Cultures Refinement of Experimental Procedures Funding of Alternatives

CHAPTER 6 - THE USE OF ANIMALS IN THE PSYCHOLOGICAL AND BEHAVIOURAL SCIENCES

Introduction Extent of Psychological and Behavioural Research i n Australia The Use of Animals in Psychological and

Behavioural Research

CHAPTER 7 - ANIMALS IN TOXICOLOGICAL TESTING

Introduction Testing Strategies Drug and Chemical Testing in Australia -Regulatory Requirements

Cosmetics General Issues in Testing Toxicological Testing in Australia National Biological Standards Laboratory The Role of Animals in Toxicological

Testing - Rationale and Alternatives Alternatives Development of Alternatives in Australia Specific Toxicological Tests

The Draize Test LDSO Test Current Status of the LDSO Test Alternatives

Regulatory Action in Australia

vi

51 55 58 59

65

65 66 68 71 73 76 77 7 9

8 1

81

83

90

97

97 98

99 1 00 1 01 1 02 1 04

107 111 114 114 114 117 118 119 121

CHAPTER 8 - THE USE OF ANIMALS IN AGRICULTURAL AND WILDLIFE RESEARCH

Agricultural Research Types of Experiment Experiments Involving Native and Feral Animals Supply, Handling and Husbandry

Observational Studies of Wild Animals Marking of Fish, Birds and Animals Radio Telemetry

Capture Conclusions Wildlife Research in Australian External Territories

CHAPTER 9 - ANIMAL HOUSE FACILITIES AND THEIR MANAGEMENT

Introduction Animal House Facilities Standards for Accommodation Quality Control

SPF Animals - Facilities, Breeding and Use in Experimentation The Economics of Laboratory Animal Breeding Rationalisation of Breeding Units Cost Recovery

Surplus Animals Standard Operating Procedures

CHAPTER 10 - THE USE OF POUND ANIMALS FOR TRAINING AND EXPERIMENTAL PURPOSES

Introduction Extent of Use Use of Pound Dogs for Teaching The Use of Pound Animals for

Experimental Purposes Policies of the Pounds Code of Practice Transport of Pound Animals Receipt of Dogs at Institutions Records The Supply of Cats from Pounds

CHAPTER 11 - ANIMAL HOUSE STAFF

Introduction Status of Animal House Staff Training in Animal Care Professional Staff

vii

125

125 126 129 131 133

133 134 134 135

136

141

141 141 145 147

152 155 156 160 161 165

167

167 167 168

170 173 175 175 176 177 177

179

179 181 185 187

CHAPTER 12 - INFORMATION AND TRAINING

Introduction Experimentation Standards Australian Council for the Care of Animals in Research and Teaching

CHAPTER 13 - ANIMAL WELFARE ADMINISTRATION IN AUSTRALIA

Introduction Commonwealth/State Responsibilities Federal System

CHAPTER 14 - CURRENT REGULATORY SYSTEM

Introduction Evolution of the Code of Practice Legislation New South Wales

Victoria South Australia Tasmania Queensland Western Australia Austra·lian Capital Terri tory

Northern Territory

CHAPTER 15 - PROPOSED REGULATORY SYSTEM

Introduction Regulation or Not Ethics Committees Code of Practice Enforcement and Accountability Legislation Monitoring Accountability Summary Commonwealth Government

CHAPTER 16 - CODE OF PRACTICE AND ETHICS COMMITTEES

Introduction Code of Practice Revision of the Code of Practice

viii

189

189 189

197

20 1

201 201 209

213

213 213 214 215 217 219 221 222 223 224 225

227

2 2 7 228 235 238 239 240 243 245 245 246

251

251 251 252

Compliance with the Code of Practice Emergencies Animal Welfare Officers Ethics Committees

Membership of Ethics Committees Consideration of Protocols Guidelines

REFERENCES

Appendix I - List of Witnesses Who Appeared Before the Committee to Give Evidence on Animal Experimentation

ix

255 258 259 260 262 266 268

271

285

TABLE

2 . 1

2 . 2

2 . 3

2 .4

2 .5

2 .6

2 .7

2.8

2 . 9

2 . 10

4 . 1

4 . 2

6.1

6 . 2

6.3

LIST OF TABLES

Numbers of Animals Used by Type of Vertebrate in Completed Experiments: Victoria, 1982-83 to 1986-87 Numbers of Animals Used and Percentage Changes

by Type of Use - Victoria, 1982-83 to 1986 - 87

Rodents Issued by Monash University Animal House 1982-1987

Numbers of Animals Used for Research Purposes in Western Australia 1981-1986 Numbers of Animals Used in Experiments in the University of Western Australia and Murdoch

University, 1980-84

Animals Issued from Central Animal Houses at the University of Sydney, University of New South Wales and the University of Queensland, 1980-84

Animals Used for Experimental and Teaching Purposes by Australian Universities, 1980-84

Animals Used for Experiments and Teaching in Australian Universities % change year to year

Numbers of Animals Used by CSIRO, 1981-82 to 1983-84

Numbers of Cattle and Sheep Used Involving Interventions or Routine Husbandry, 1981-82 to 1983-84

Possible Interpretation of Total Scores from an Overall Assessment of an Experimental Animal

Research Techniques, Pain and Distress

Animals Used in Psychological and Behavioural Research in Victoria by Techniques

Animals Used in Psychological and Behavioural Research in Victoria

Experiments to Study Behaviour in Animals

xi

11

1 2

1 3

14

15

17

17

18

19

20

52

54

85

86

86

6.4 Statistics of Animals Used in Teaching and

Research in the Behavioural Sciences in Australian Universities

6.5 Australian Behavioural Research Literature Survey

6.6

1966-1983 - Species of Animals and Numbers of Experiments

Australian Behavioural Research Literature Survey 1966-1983 - Types of Experiments

6 . 7 Australian Behavioural Research Literature Survey

7 .1

7.2

1966-1983 - Number of Experiments Performed at Various Institutions

The Numbers of Small Animals Issued to Users From NBSL 1975-1988

Number of Animals Used in Toxicological and Pharmacological Testing in Victoria 1982-1987

xii

88

89

89

90

105

107

AAC

AAHR

AATA

ABAH

ACC ART

AE EC

AFWA

ANAHL

ANU

ANZFAS

APS

ARC

ARRP

ASAC

AS LAS

ASMR

AVA

AVCA

AVCC

AWAC

CSIRO

CTFAA

DARA

ABBREVIATIONS USED IN REPORT

Australian Agricultural Co unc il

Au s tralian Associatio n f o r Humane Research

Au s tralian Animal Technicians Association

Australian Bureau of Animal Health

Australian Council for the Care of Animals in Research and Teaching

Animal Experimentation Ethics Committee

Australian Federation for the Welfare of Animals

Au s tralian National Animal Health Laboratory

Australian National University

Australian and New Zealand Federation of Animal Soc ieties

Australian Psychological Society

Animal Resources Centre

Animal Research Review Panel

Antarctic Scientific Advisory Committee

Australian Society for Laboratory Animal Science

Australian Society for Medical Research

Australian Veterinary Association

Australian Veterinary Chemicals Association

Australian Vice-Chancellors' Committee

Animal Welfare Advisory Council

Commonwealth Scientific and Industrial Research Organisation

Cosmetic, Toiletries and Fragrance Association of Australia

Department of Agricultural and Rural Affairs

xiii

DASETT

DCSH

DITAC

JAWC

NBSL

NHMRC

NIH

OTA

RSPCA

UFAW

UNSW

USDA

Department of Arts, Sport, Environment, Tourism and Territories Department of Community Services and Health

Department of Industry, Technology and Commerce

Joint Animal Welfare Council National Biological Standards Laboratory

National Health and Medical Research Council

National Institute of Health

Office of Technology Assessment

Royal Society for the Prevention of Cruelty to Animals

Universities Federation for Animal Welfare

University of New South Wales

United States Department of Agriculture

xiv

LIST OF RECOMMENDATIONS

2.30 The Committee RECOMMENDS that the Commonwealth, State and Territory Governments publish annually accurate and

comprehensive information on the extent and forms of animal

experimentation conducted within their respective jurisdictions. In addition, government authorities should provide some analysis of the statistics to make them meaningful to the public, and to

reduce the potential for misinterpretation.

5.49 The Committee RECOMMENDS that the Commonwealth

Government establish a separate fund for research into the use of alternatives to animal experimentation and that grants be

disbursed from this fund by a board composed of representatives of the scientific community, animal welfare organisations, ACCART and government authorities.

7.80 The Committee RECOMMENDS that the Draize test be

banned in Australia.

7.81 The Committee RECOMMENDS a ban on the classical LDSO

test in Australia but that acute toxicity tests be allowed with ministerial approval.

8.41 The Committee RECOMMENDS that ACCART in co-operation with the relevant bodies with specialist knowledge draw up

appropriate guidelines and standard operating procedures for the capture of wildlife and their housing, nutrition and management in captivity.

XV

8.48 The Committee RECOMMENDS that Antarctic research

protocols be assessed and approved under the Code of Practice and that additional detailed guidelines be drawn up on the

techniques, procedures and practices to be used by experimenters on animals in the Antarctic.

9.34 The Committee RECOMMENDS that all institutions which

conduct animal experimentation have periodic analyses done on animal feed to ensure that it is of a high and consistent

quality, not only to maintain standards of animal welfare but also to guarantee the validity of experimental data.

9.69 The Committee RECOMMENDS that animal house supply and breeding units develop appropriate pricing policies to enable recovery of all recurrent costs including caging and minor

equipment and that surpluses generated be used to develop animal house facilities.

9.80 The Committee RECOMMENDS that a study be undertaken by ACCART to determine the most effective means for production

planning of laboratory animals in terms of minimising excess production.

10.29 The Committee RECOMMENDS that State Governments

legislate so that pounds hold dogs for at least seven days before disposing of them to an institution except where a dog is

surrended by its owner.

10.30 The Committee RECOMMENDS that State Governments

legislate so that all owners who surrender dogs to pounds be

informed in writing of the possible transfer of the animals to a research institution and that pounds obtain the written

authorisation of owners to transfer the dogs to an institution.

xvi

10.46 The Committee EECOMMENDS that institutions either breed or purchase cats from an institution in which they are bred for exp e rimental purposes and not acquire them from pounds or other non-institutional sources.

11 . 29 The Committee RECOMMENDS that all institutions with

a n imal houses require unqualified staff to undertake technical

training courses in animal care at colleges o f technical and

f u r ther education.

1 2.18 The Committee ... RECOMMENDS that extra funds be made

a vailable by the Commonwealth Government to enable the University

of Sydney to establish a course in laboratory animal science.

12.20 The Committee RECOMMENDS that funds be made available to the University of Queensland to establish a chair in animal

welfare and behaviour.

1 3 . 46 The Committee RECOMMENDS that all States and Territories

upgrade animal welfare legislation, and establish animal welfare advisory councils and departmental animal welfare units as has been done in New South Wales, Victoria and South Australia.

15.57 The Committee RECOMMENDS that the system of controlling a nimal experimentation in New South Wales, Victoria and South

Australia be extended to the other States and Territories . This

system is based on upgraded legislation; incorporation of a code of practice in regulations; the accreditation and licensing of i nstitutions in which animal experimentation is conducted; and

the appointment of inspectors to monitor the work of ethics

committees, animal house facilities and practices, and the

conduct of animal experimentation .

xvii

15.69 The Committee RECOMMENDS that the Commonwealth

Government enacts legislation to remove any doubt that the

conduct of animal experimentation by Commonwealth employees comes under the control of Commonwealth authorities.

16.15 The Committee RECOMMENDS that future revisions of the Code of Practice be carried out by a national conference

consisting of representatives of governments, institutions which conduct animal experimentation, experimenters, animal house staff, specialist societies, animal welfare organisations, educational organisations and funding bodies and that final

approval for those revisions be given by Commonwealth, State and Territory Governments which include the Code of Practice in

regulations.

16.62 The Committee RECOMMENDS that the Australian Council for the Care of Animals in Research and Teaching prepare guidelines on procedures and practices in relation to animal experimentation to supplement the Code of Practice.

xviii

CHAPTER 1

INTRODUCTION

of the Committee and its Terms of Reference

1.1 The Senate appointed the Select Committee

Welfare on 16 and 17 November 1983 and reappointed

February 1985 and again on 22 September 1987, in

Parliament, to inquire into and report upon:

the question of animal welfare in Australia with particular reference to:

interstate and overseas commerce in

animals;

wildlife protection and harvesting; animal experimentation; codes of practice of animal husbandry for all species; the use of animals in sport.

on Animal it on 22

each new

1.2 Because of the wide scope of the terms of reference, the

Committee decided to divide the inquiry into a number of discrete areas and, as far as possible, to examine two or more

simultaneously.

1 . 3 Although the Committee took a little evidence on animal

experimentation in preliminary public hearings in mid-1984, the Committee decided to defer its consideration of this area in

order to give priority to investigations into kangaroos, the export of live sheep from Australia and the keeping of dolphins and whales in captivity. The Committee reported on live sheep exports on 13 August 1985, on dolphins and whales in captivity on

29 November 1985 and on kangaroos on 1 June 1988. The Committee has also been examining animal welfare issues in sheep husbandry and has taken evidence in other areas of animal husbandry.

1

Conduc t of the Inquiry

1 .4 In this report the Committee examines the use o f animals

in experiments in research and t oxicological t esting b u t not,

e xcept in some peripheral areas , in teaching. The Committee has

taken very little evidence on the use of animals in primary and

secondary schools while its consideration of their use in

tertiary courses has not been extensive. This area will therefore be taken up later in the Committee's general inquiry into anima l welfare .

1 . 5 Some preliminary evidence on the use of animals in

r esearch and teaching was taken during hearings of the Committee

between May and September 1984. The evidence taken then made it clear to the Committee that publicly available information on the extent and nature of the use of animals in experiments in

Australia was extremely limited.

1.6 In order to obtain information about animal

experimentation in Australia to help prepare for further

hearings, the Committee prepared a questionnaire . The

questi onnaire covered the nature and extent of animal use; the development of alternatives; the constitution, operation and membership of ethics committees; compliance with the Code of Practice; animal supply; animal house facilities; and animal house staff.

1.7 The questionnaire was sent to universities, hospitals

and other research institutions that were known to use animals in research and teaching. Fifty completed questionnaires were returned to the Committee . Additional copies of those completed by universities were sent to the Australian Vice-Chancellor's Committee by arrangement between the Committee and the AVCC.

2

1.8 The Committee held hearings and conducted inspections of animal house facilities at universities and other institutions in al l State capitals and Canberra between August 1986 and November 1988 . The Committee received submissions and took oral evidence

from a wide range of organisations and individuals . A list of

witne sse s who gave oral evidence is provided in Appendix 1 .

Nomenclature

1 . 9 During the inquiry, the Committee found that people used

d i ffere nt terms to describe the same thing. The Committee

d ecided, in order to avoid confusion, to standardise as far as

possible on key terms in this report.

1.10 A person who conducts experiments on animals is called a researcher by some people, an investigator, an experimenter or a s c ientist by others. The Committee has decided to refer to such a pe rson as an experimenter or scientist, depending on context.

1. 11 An application to carry out a project in which

e xperi ments are conducted on animals is referred to as a

protocol. Although the word 'proposal' is used in the Code of

Practice, the meaning of the word may be confused with the more general meaning of the word in some contexts . Such ambiguity is not likely to happen with the word 'protocol'.

1 . 12

' Code

The term 'Code of Practice' refers specifically to the of practice for the care and use of animals for

e xperimental purposes' which was issued in 1985 by the National Health and Medical Research Council , the Commonwealth Scientific and Industrial Research Organisation and the Australian Agricultural Council . The Code of Practice has

recently been revised but the revised edition has not yet been endorsed by all of its sponsors. The latest draft given to the

Committee by the NHMRC was dated 22 February 1989. It is referred to in this report as the 'draft revised Code of Practice.'

3

1.13 The Committee uses the term 'ethics committee' to denote

the term 'animal experimentation ethics committee' used in the Code of Practice or 'animal care and ethics committee' used in

New South Wales l e gislation or the variations of it used in some

institutions.

1. 14 A lis t of acronyms and abbreviations used in the repo r t

is set out at the front of the report .

An imal Ex perimentation Debate

1.15 Animal experimentation has been an area of animal use

that has been at the forefront of the animal welfare debate for a long time . In the United Kingdom, anti-vivisection .organisations have opposed the use of animals in experiments for two hundred years or more. At the birth of the current animal welfare

movement in Australia in the mid 1970s, animal experimentation was identified as a key area of animal use for abolition or

reform .

1 . 16 The

homogeneous animal welfare movement in Australia is not a

body with a single set of policies. Its constituent organisations and other

have differing policies on animal experimentation animal welfare issues. Although some of those

organisations espouse an uncompromising policy of immediate abolition of the use of animals in experiments, other

organisations, while maintaining a long-term goal of abolition, take a more pragmatic position by seeking reforms in the short term to enhance animal welfare.

1.17 A diversity of views

exists within the scientific

acknowledges marked changes experimentation even during the questionnaire distributed to some

4

on animal experimentation also community. The Committee

in attitude towards animal

course of its inquiry. The

50 institutions and the long

series of public hearings focussed attention on the subject. It made institutions and experimenters think more about the ethical, welfare and scientific issues involved in animal experimentation. In many institutions, ethics committees are now working better,

controls have been tightened, facilities have been upgraded and greater attention has been paid to the care of animals. There is also a growing realisation within the scientific community that reproducible experimental data requires a close definition of the

health and genetic status of the animals used in the experiments. Better facilities will be needed to provide the higher quality animals which are now required in many research projects.

1.18 The Committee distributed the questionnaire because of the paucity of information publicly available about the use of animals in experiments in Australia. Experimenters and scientific institutions have traditionally been reluctant to disseminate

information about their use of animals and the facilities in

which they are housed. This attitude has been adopted largely as a reaction to opposition to animal experimentation from various

animal welfare organisations. Some issues focussed on by such organisations have been blown out of perspective by the media. Added to this have been the acts of wanton vandalism against

institutions or personal property of experimenters perpetrated by fringe elements of the animal welfare movement. Fortunately, the extent of such criminal activity ,in Australia has been minimal compared to the level of violent activities in some other

countries. Nevertheless, it has been a matter of concern to

experimenters and research institutions.

1.19 There is no doubt that the majority of the population

supports biomedical research involving the use of animals1

provided that effective controls are operating to keep the number of the animals and the level of pain and distress to a

Until such time as the majority of Australians are persuaded that

5

animal experimentation should not be carried out, and that is

translated into legislative form, experimenters have a right to use animals within the regulations and guidelines imposed on such use by government and the scientific community.

1. 20 The Committee condemns the use of violence to attain

objectives which cannot be attained by rational argument or

legitimate and lawful activity. Violence causes revulsion and is in most cases counter-productive. It will also adversely affect the work of other organisations and individuals who are striving to improve animal welfare and reduce the number of animals being used in experiments by legitimate means. Those people who pursue their cause by illegal means should be subject to the full force of the law.

1. 21 There is a general feeling within the scientific

community to withdraw behind barriers when faced with violence or other illegal actions. That attitude is quite understandable. Yet it has been the secretive approach in the past and the reluctance to publish information about their use of animals in experiments which have led to public misapprehension about the nature of

animal experimentation in this country. Secrecy breeds suspicion and the media feed on suspicion. What might have been a

misunderstanding becomes a crisis.

1. 22 The

institutions most potent weapon in the armoury of research

is public opinion. If the public is satisfied that animals are being used humanely in experiments, there is little threat to such use. It is important, therefore, for institutions to be open and forthcoming about their experimental practices. Responsible animal welfare organisations should also be able to inspect institutional facilities. This would help to allay

suspicions that animals are being housed in poor facilities or are not being given proper care.

6

1.23 Institutions and government have a responsibility to

ensure that animal experimentation is conducted humanely in accordance with approved rules and guidelines. By fulfilling that responsibility and by keeping the public informed of the extent and nature of animal experimentation, public disquiet should be

kept to a minimum.

Acknowledgements

1.24 The Committee wishes to thank all the people who made

submissions, inquiry. In

Committee: Mr D. Pratezina.

gave evidence or otherwise contributed to the

particular, it wishes to thank the staff of the

P. Barsdell, Mr D. Hynd, Ms B. Allan and Mrs

7

CHAPTER 2

ANIMAL EXPERIMENTATION IN AUSTRALIA

Introduction

2.1 Few statistics are kept of the extent and range of

animal experimentation conducted in Australia . Consequently, the Committee does not have accurate figures on the number of

e xperiments conducted or the number of animals of each species which have been used in experiments. It also follows that the

Committee does not know with any degree of accuracy whether the use of animals in experiments is increasing or decreasing.

2 . 2 The Victorian and Western Australian Governments collect

statistics on animal experimentation and the New South Wales Government will do so under its new legislation . The other States and Territories do not collect such statistics.

2.3 In this chapter the Committee sets out the statistics

and other information available to it to form a rough picture of the pattern of animal experimentation in Australia.

Victoria

2.4 currently Affairs

Detailed statistics on animal experimentation are collected by the Department of Agriculture and Rural in Victoria. These statistics are based on the biannual returns submitted by individual experimenters to the Department. These figures have been published in an annual report entitled

'Statistics of Animal Experimentation'. The figures are now available for the period July 1982-June 1987. The public

9

availability of detailed statistics for a five year period

enables some conclusions to be drawn as to the broad patterns of use of animals as well as trends in Victoria.

2.5 Table 2.1 provides information on the number of animals

used annually by species of vertebrate in Victoria from July 1982 to June 1987. The Victorian figures do not include animal

experimentation carried out in Commonwealth establishments in Victoria.

2 . 6 The Victorian statistics are based on animals used, not

on the number of scientific procedures carried out. Dr Crossing of the Department of and Rural Affairs explained

that:

The legislation provides for a series of

related scientific procedures, or a scientific procedure. In other words, one can have a

program made up of a number of similar

scientific procedures or it can be classed as one experiment. We do not count experiments. What we are looking at is the usage of

animals, because it is possible to describe a series of related scientific procedures as one experiment. It can be difficult to

differentiate between those, so we look for

the number of animals used, amongst other

things.!

2.7 Table 2.2 summarises the number of animals used and

percentage changes from year to year, by type of use,

period July 1982 to June 1987.

10

for the

Table 2 .1: Nt.nnbers of An.inals Used bv Type of Vertebrate in Completed Experiments: Victori at 198 2-83 t o 1986-87

Total % Change

Type of Vertebrate 82-83 83-84 84-85 85-86 86 - 87 82-83/83-84 83 - 84 / 84-85 84-85/85-86 85 - 86/86- 87

Mouse 121 447 151 734 119 840 168 508 125 399 +24.7% - 21.0% +40.6% - 25 . 6%

Rat 37 077 52 819 38 622 51 995 39 429 +42.4% -26.9% +34.6% -24 .2%

Guinea Pig 3 983 3 354 2 480 2 276 2 758 -15.8% - 26.0% -8.2% +21.2%

Other Rodent 21 34 66 21 +62 . 0% +94.1% n.c. n.c.

Rabbit 2 641 2 482 2177 3 276 4 179 - 6.0% -22.3% +50.5% +27.6%

Cat 379 271 290 303 217 -28.5% +7.0% +4.5% -28 . 4%

DJg 781 597 551 788 663 -23.6% -7.7% +41. 2% -14.8%

Other Carnivore 7 188 4 98 +2 685.0% -97 . 9% +2 450.0% n.c.

Horse, D:mkey or Cross 57 24 8 109 9 -57.9% +66.7% +1 362.0% -91.7%

Bovine 1 827 1 007 994 1 165 1 398 -44.9% -1.39% +17.2% +20.0%

Sheep 9 214 5 886 12 355 10 646 7 788 -36.1% +110.9% -13.8% -26. 8%

Goat 281 184 1 192 198 570 -34.6% +5 489.0% -83.4% +287.9 %

Deer 12 n.c. n .c. n.c. n.c.

Pig 1 038 1 205 1 091 4 536 5 178 +16.1% - 9.5% +415.8% +114.2%

Other Ungulate 30 n . c . n. c . n.c. n. c .

Marsupial 314 200 289 329 360 -36 . 3% +144.5% +13. 8% +9.4%

Prinate 9 3 10 21 41 -66.7% -233.0% +210.0% +195. 2%

Other Manm3.l 107 172 26 12 2 +3.0% - 84.9% -53.8% - 83.3%

IX:Irestic Fowl 23 593 23 804 24 430 28 547 35 622 - 7.0% +2.6% +16.9% +24. 8%

Other IX:Irestic Poultry 206 89 9 97 - 56.8% -89 . 9% +1 007 . 7% n. c.

Other Bird 63 261 131 61 107 +414.0% -49.8% - 53.4% +75 . 4%

Amphibian 3 460 2 268 2 602 1 838 2 761 -34.5% +14.7% -29 . 4% +150 . 0%

'lUI'AL 206 505 246 612 207 167 274 815 226 502 . +19.4% - 15.8% +3 2.6% -17. 6%

SOORCE: Victorian D:!partrrent of Agriculture and Rural Affairs: 'Statistics of Animal Experimentation'.

Table 2.2: Numbers of Animals Used and Percentage Changes by Type of Use - Victoria, 1982-83 to 1986-87

82-83 83-84 84-85 85-86 86-87

Research 189,901 218,031 184,880 259,885 203,679

Investigation +14.8% -15.3% +40.6% -21.6%

Diagnostic 1,853 2,885 1,943 881 801

Procedure +55.7% - 32.7% -54.7% -9.1%

Education 11,355 10,547 12,541 10,734 12,527

-7.1% +11. 9% -14.4% +16 . 7%

Production of 1,655 1,594 2,807 2,251 3,001

Biological -3.7% +76 .1% -19.2% +33 . 9 %

Products

Product Quality 325 3,215 4,805 747 6,408

Testing +989% +49.5% -85.4% +857.8%

Other 1,416 10,340 191 317 86

+730% -98% +66% -72.9%

TOTAL 206,505 246,612 207,167 274,815 226,502

+19.4% -15.8% +32.6% -17.6%

SOURCE: Victorian Department of Agriculture and Rural Affairs: 'Statistics of Animal Experimentation'.

2.8 The category of 'Education' in the Victorian statistics

refers solely to animals used for educational programmes in

tertiary institutions and does not include any animals that may have been used in primary and secondary schools.

2 . 9 The Victorian statistics for this period of five years

do not show any decline in the use of animals in research.

Although the annual totals fluctuate, in no year has the total

number of animals used annually not dropped below the level of 1982-83, the first year for which statistics were collected.

12

2.10 An examination of the statistics of rodents issued by

the Monash University central animal house

University but also for sale to other institutions in Melbourne and interstate. The figures of animals issued

Table 2.3: Rodents Issued by Monash University Animal House 1982-1987

Year

1982 1983 1984 1985 1986 1987

Mice

25,093 20,545 23,770 24,440 22,186

28,962

Rats

60;334 53,942 63,337

60,763 55,196 57,246

SOURCE: Compiled by Committee from response to questionnaire

Western Australia

2.11 purposes Australia

A summary of the numbers of animals used for research were provided by the Health Department of Western

for the years 1981-1986 is contained in Table 2.4.

There was no breakdown of the use of animals into categories of experiments.

13

Table 2.4: Numbers of Animals Used for Research Purposes in Western Australia 1981-1986

Type of Animal 1981 1982 1984 1985 1986

Mice 1 723 2 263 2 495 1 430 2219 1644

Rats 2 753 3 290 2 253 2 176 2403 2236

Dogs 465 447 327 300 401 586

Cats 104 86 105 141 112 68

Sheep 8 979 7 696 12 138 14 034 10331 12788

Cattle 14 52 72 80 21 12

Other 1 966 2 587 3 217 2 907 2284 2177

TOTAL 16 004 16 421 20 607 21 068 17771 19511

SOURCE: Health Department of Western Australia.

2.12 The use of animals in the categories of experiments

covered by the Health Department return has increased by about 25 per cent over the period of four years for which figures are

available.

2.13 The number of animals recorded in these statistics is

substantially less than the combined total of those provided to the Committee by Murdoch University and the University of Western Australia, which are shown in Table 2.5.

14

Table 2.5: Numbers of Animals Used in Experiments in the University of Western Australia and Murdoch University, 1980-84

1980 1981 . 1982 1983 1984

39,890 43 , 976 43,578 96,388 86,738

SOURCE: Compiled by Committee from responses to questionnaire.

2.14 According to the Health Department, the difference is

by the instructions contained in the 'Notes on explained Completing the Annual Statistical Vivisection and Experiments Return Form' which include the following:

Information is only required on operations and other experiments of a similar nature which are performed on living animals.

Purely sacrificial procedures are not

included, nor are necropsies, dissection or experiments on dead animals.

Under the Regulations information is not required on any operation of the nature of an inoculation or feeding experiment.

The form of statistical return is directly covered by the

provisions of Western Australian Prevention of Cruelty to Animals Act 1920-1976, sections 6 <1> F and 6 <1> G.

2.15 category they are

in animal

them.

The statistics relate, therefore, only to a limited

of uses of animals for experimental purposes. Because not comprehensive, few conclusions as to overall trends experimentation in Western Australia can be based on

15

Universities

2.16 One

experimentation section of

sent out by

the

the

hospitals types of

and research institutions, animal experimentation institutions.

questionnaire Committee to on animal

universities,

dealt with the extent and at those being conducted

2.17 The replies from the universities fall into three

groups.

2.18 Four universities were unable to details of which

animals were used for all facilities and departments for the five year period 1980-84. Included in this group were Griffith

University, Macquarie University, the University of and

the University of Tasmania. To ensure consistency and

comparability, any figures supplied by them were not included in the tables which follow.

2.19 Three universities were able to supply details of

animals issued for the period 1980-1984 from their respective central animal houses but were unable to supply full details for all other departments and breeding units for this period. They were the University of Sydney, the University of New South Wales

and the University of Queensland. The statistics for the central animal houses of these universities are provided in Table 2.6.

2.20 The statistics for animals used for experimental and

teaching purposes for the other 12 universities in existence at the time the questionnaire was issued are provided in Table 2.7. Table 2.8 reports the annual percentage change in the number of animals used for each of the four categories in Table 2.7.

2.21 Table 2.8 reports the annual percentage changes for each category of animals.

16

Table 2.6: Animals Issued from Central Animal Houses at the University of Sydney, University of New South Wales and the University of Queensland, 1980- 1984

1980 1981 1982 1983 1984

Mice 67,771 53,939 61,945 54,205 53,275

Rats 29,180 28,934 29,692 31,690 33,242

Guinea Pigs 3,233 2,639 3,485 3,414 2,812

Other Animals 10,689 9,089 8,214 8,597 7,681

TOTAL 110,873 94,601 103,336 97,906 96,010

SOURCE: Compiled by Committee from responses to questionnaire.

Table 2.7: Animals Used for Experimental and Teaching Purposes by Australian Universities*, 1980-84

Mice

Rats

Guinea Pigs

Others

TOTAL

1980

198,698

99,344

4,097

43,839

345,978

1981

182,133

94,132

4,746

36,751

317,762

1982

195,494

106,262

4,842

46,182

352,780

1983 1984

216,644 205,546

111,682 118,172

4,759 4,856

56,796 45,245

389,881 373,819

* Universities include: Newcastle, New England, Flinders, La Trobe, James Cook, ANU, Deakin, Wollongong, Monash, Adelaide, Murdoch, Western Australia.

SOURCE: Compiled by Committee from responses to questionnaire.

17

Table 2 . 8: Animals Used for Experiments and Teaching in Australian Universities* % Change Year to Year

1980-81 1981-82 1982-83 19 83 - 84

Mice -8.39% +7.3% +10.8% -5.1 %

Rats -5 . 2% +12.9% +5 .1% +5 . 8 %

Guinea Pigs +15.8% +2.0% -1.7% +2.0 %

Other Animals -16.2% +25. 7% +23.0% -20.3 %

TOTAL -8.1% +.11% +10.5% -4 .1%

* Universities as defined for Table 2. 6.

SOURCE: Compiled by Committee from responses to questionnaire .

2 . 22 Few firm trends in animal use for experiments and

teaching in Australian universities are apparent in the

statistics presented in Table 5, 6 and 7. There are substantial variations in the numbers used from year to year for most species of animal.

2.23 As Table 2.9 shows, the CSIRO has an extensive

involvement in the use of animals for research purposes. The

Committee notes that many farm animals used by CSIRO for purposes of research were subjected only to normal husbandry practices . The CSIRO submitted that:

In laboratory tests it is taken that some

intervention to the animals occurs, eg

injection, bleeding, or dosage of a drug or

infection Agent. In animal husbandry tests,

18

animals are subjected only to normal farming practices, with the possible exception of

occasional weighings, for example in an animal breeding trial.2

2.24 Table 2.10 provides a comparison between the number of

sheep and cattle used in laboratory tests with those used in

animal husbandry research.

Table 2.9: Numbers of Animals Used by CSIRO, 1981-82 to 1983-84

1981-82 1982-83 1983-84

Cattle 3 797 3 560 3 587

Sheep 24 341 22 890 22 769

Goats 66 4 11

Pigs 202 196 191

Horses/Donkeys 5 5 5

Marmosets 38 18 48

Dogs 19 17 14

Rabbits 461 397 407

Guinea Pigs 1 063 1 092 1 298

Rats 9 991 7 216 7 157

Mice 118 530 130 904 110 863

Chickens 13 302 13 847 14 524

Other 152

161 815 180 498 160 854

SOURCE: Table 4, CSIRO, Additional Information supplied to the Committee on 27 November 1985 in response to questions at hearing, 3 July 1984.

19

Table 2.10: Numbers of Cattle and Sheep Used Involving Interventions or Routine Husbandry, 1981-82 to 1983-84

Cattle Sheep

Inter- Routine Inter- Routine

Year vention Husbandry Total vent ion Husbandry Total

1981-82 527 2,207 2,734 6,675 8,471 15,146

1982-83 353 2,287 2,640 5,906 7,815 13,721

1983-84 397 2,326 2,723 4,969 5,706 11,175

SOURCE: CSIRO - Additional information supplied to the Committee on 27 November 1985 in response to questions at hearing, 3 July 1984, Table 6.

2.25 The CSIRO statistics show a pattern which appears to be

common to the statistics supplied by the . universities and the

Victorian Department of Agriculture and Rural Affairs, of

substantial annual variations without any clear long-term trend.

Conclusions

2.26 The Committee believes that there is a need for the

Commonwealth, State and Territory Governments to publish annually details of the numbers and particular uses of animals, by

species, used in experiments

experiments, including husbandry dead animals should be included

in research and teaching. All

and observational, on living and in the statistics. There is no

difference, for statistical purposes, between animals which are killed before experiments are conducted on them and animals which are killed after having undergone experiments.

20

2.27 Statistics by themselves can be subject to various

interpretations unless some analysis is provided by the

Government to assist the reader. For example, alternatives to the use of animals might have been introduced in a range of projects but a single project involving a large number of rodents might

I

distort the total figure giving the impression that alternatives were not gaining ground within the scientific community.

Similarly, a marked increase in funds available for research in one year could increase the number of projects carried out

resulting in an increase in the total number of animals used even though the average number of ani1nals used for each project might have declined.

2 . 28 The scientific community has been wary about the

publication of statistics of animal use in because of

the potential misinterpretation of those statistics by the

public. The Committee believes that the public has the right to know the extent of use of animals in experiments in Australia and that the statistics should therefore be published. However, it would be preferable for some analysis to accompany those

statistics to make them more meaningful to the public and to

reduce the possibility of misinterpretation.

2.29 The collection of such statistics need not be onerous or

expensive, either for the institutions or for the government departments or authorities responsible for animal welfare. Animal houses need to keep accurate records if they are to be managed

efficiently. Ethics committees also need this information for their role

institutions. in monitoring animal experimentation in their

It should be, therefore, little more than an

exercise of collating data for inclusion in statistical returns with some additional analysis of the statistics.

21

2.30 The Committee RECOMMENDS that the Commonwealth, State and Territory Governments publish annually accurate and

comprehensive information on the extent and forms of animal

experimentation conducted within their respective jurisdictions . In addition, government authorities should provide some analysis of the statistics to make them meaningful to the public, and to

reduce the potential for misinterpretation.

22

CHAPTER 3

THE MORAL STATUS OF ANIMALS

AND THE ETHICS OF ANIMAL EXPERIMENTATION

Introduction

3.1 The scientific community put forward a number of

arguments to justify the use of animals in experiments, few of which were philosophical in nature. Instead, the practical

benefits of such experiments were heavily emphasised, as was the fact that animals are irreplaceable in some forms of

experimentation. These arguments are discussed in later chapters dealing with specific areas of research.

3.2 Opponents of animal experimentation have criticised the actual practice of animal experimentation but have largely based their case against the use of animals in experiments on

philosophical arguments about the moral status of animals.

3 . 3 In surveying the philosophical debate, the Committee

noted that leading advocates of the animal welfare movement, such as Professor Torn Regan and Professor Peter Singer, offer

different philosophical rationales for their views on the moral status of animals. Although their conclusions are similar, they argue their respective cases along different lines. In fact,

there is no unanimity either in philosophical circles or in the animal welfare movement on the exact moral status of animals and the accompanying question of the use of animals in experiments.

3.4 This chapter will therefore be devoted to an outline of

the main arguments that have been placed before the Committee concerning the moral status of animals, at the end of which the

Committee draws its own conclusions.

23

Historical Perspective

3.5 Debate over the moral status of animals and the ethics

of animal

philosophical experimentation is not simply a contemporary

fad. The issue was discussed by the earliest Greek physicians, while anatomical researchers during the Renaissance developed arguments to justify vivisection.!

3. 6 The 17th century French philosopher Descartes developed a position on the nature of animals and their ability to

experience pain that was to be very influential. Animals were viewed as automata that could not experience real pain. It was believed they went through external motions which in humans are symptomatic of pain without experiencing its mental sensation . Descartes' arguments were used to

physiological experiments on animals.2 justify undertaking

3.7 The Cartesian position finds very little support in

current debates over animal experimentation. There are, however, philosophical positions being put forward currently which deny any significant status to animals. The philosopher, R.G. Frey, for example, argued that animals have desires but not minds. They have no interests and no rights. They can therefore be

legitimately used and exploited by humans.3

3.8 Others base the right of humans to use animals with

minimal restriction on a variety of religious and scientific

arguments. There is the evolutionary theory; humans are at the top of the evolutionary ladder and are therefore superior to

animals. There are also fundamentalist interpretations of the Biblical story of man being given dominion over the animals.4

24

3.9 Much more common is the 'humane' interpretation of the

right of humans to use animals. On this principle humans must not cause animals unnecessary pain and distress. However, animals do not have inherent rights and may be killed painlessly for

legitimate purposes. As a test of necessity, the criterion of

legitimate purposes, seems weak. Apart from outright cruelty or obviously pointless use, almost any purpose could be argued to be legitimate. No rigorous evidence or argument is required on this basis to justify animal experimentation.

As it is presently articulated, humane

beneficence, fails to provide criteria for

determining the legitimacy of those human

purposes in whose service animals may be

caused pain or distress. In practice,

traditional adherents of beneficence tend to find virtually all animal research

justifiable.S

Utilitarianism and Suffering

3.10 In recent years, the most common philosophical argument in the debate over the use of animals in experiments has been

utilitarian in form. It can be used, however, to argue a case

either for or against animal experimentation.

3.11 Utilitarianism involves the calculation of the

consequences of action in terms of the total costs and benefits or, alternatively, pleasure and pain. The positive outcomes

should outweigh the costs of any course of action or project .

3.12 Simply put, permissive utilitarianism justifies

particular painful experiments on the grounds that the pain

e xperienced by animals will be more than outweighed by the

benefits resulting from the relief of suffering of humans or

other animals, or other improvements in the quality of human

life. Human pain in this calculation is regarded as intrinsically

25

worse and is therefore given a greater weighting in the

calculation than animal pain. Conversely, human enjoyment ,

heavier weighting than similar assumed to be richer and much

pleasure or benefit will carry a animal experiences because it is wider in its scope.

3 . 13 The calculation of pain and benefit can be developed t o

justify a quite different position on animal experimentation. In this view animal research causes more pain than benefit. This is based on the assumption that very little animal research produces significant benefits for humanity although many experimental techniques inflict significant pain and distress on the animals used. Dr Judith Hampson, who gave evidence on behalf of ANZFAS, argued that the vast majority of animal experimentation is not done to conquer life-threatening diseases.6

3.14 An essentially utilitarian argument that is critical of the use of animals in experiments need not take, however, the

form just outlined.

3.15 An Australian philosopher Professor Peter Singer has

made a significant contribution to the development of an

alternative line of argument. The core of his argument is that

the granting of moral consideration to a subject is grounded in the capacity to suffer pain or to experience pleasure:

the principle of equal consideration of interests is sensitive to differences in the kind of interests different beings may have. But the fundamental common interests between humans and other animals remains the interest in not experiencing pain and suffering. The only acceptable limit to our moral concern is the point at which there is no awareness of

pain or pleasure, and no preferences of any

kind. That is why the principle of equal

consideration of interests has implications for what we may do to rats, but not for what

we may do to lettuces. Rats can feel pain, and

pleasure. Lettuces can't.?

26

3.16 The key principle for Professor Singer in his

calculation is equality of consideration. This does not imply that both humans and animals must be treated in the same way. The principle of equality does not require equal or identical

treatment; it requires equal consideration which may lead to different treatment. If the demand for equality for animals was based on the actual equality of animals it could be refuted

simply because it is not true. Animals vary greatly in their

capacities and attributes. Equality here is a moral idea not an assertion of fact. The principle of equality is a prescription as to how we should treat animals. As this principle is stated in

the ANZFAS submission:

3.17

it is reasonable to regard the death of a fish as a smaller loss than the death of a

normal human - smaller to the fish because the fish does not have hopes and plans for the

future which are unable to be fulfilled, and

smaller for others because there is not the

same kind of grief and mourning that is likely to attend the death of a normal human. But in

making such a distinction, we are not saying that the death of a fish matters less because

the fish is not a human being. It is not the

species of the human and the fish that

matters, but their capacities. So, on the same grounds, if there were a human being so

severely brain-damaged as to be on a par with the fish, and if there was no-one who cared in

the least for this unfortunate human being, then the death of this human being would also be a smaller loss than the death of a normal

human being.S

Professor Singer argued that if this principle of

equality is violated with respect to animals, then this attitude of violation may be referred to as 'speciesism'. He posed the

question: if possessing superior intelligence does not entitle one human to use another for his own ends, how can it entitle

humans to exploit non-humans for the same purpose?

27

3.18 This then leads to the question: what characteristic is

it that gives a being the right to equal consideration? Professor Singer's answer was: the ability to suffer. If a being suffers

there can be no moral justification for refusing to take that

suffering into consideration. The principle of equality requires that suffering to be counted equally with like suffering. If a being is not capable of suffering then there is nothing to be

taken into account.9

Difficulties with Utilitarianism

3.19 There are problems with utilitarianism based simply on

the calculation of benefits and costs as a practical moral

theory. Within the context of animal these take a

number of forms.

3.20 Although it

pleasure it is even

is difficult to measure human pain and

more difficult to do so for animals. The

issue of animal pain and distress and their measurement is

discussed in Chapter 4.

3.21 Conceptually, it may not be possible to quantify animal

pain and distress in the way that the utilitarian calculus

requires. Although we may be able to make approximate comparative judgements about the level of pain inflicted on animals of the same species, accurate comparisons among different species is virtually impossible, especially as pain perception is influenced

by psychological and environmental factors.

3 . 22 Pleasure, too, is impossible to quantify. What is

pleasurable to one person may not be to another. Even if

something gives pleasure to many people, the intensity and

duration of pleasure varies among individuals. If it is

impossible to quantify both pain and pleasure, how does one

compare pain and pleasure to give effect to the utilitarian

calculus?

28

3.23 Even assuming for the purposes of the argument that the

calculations can be made, there is a further problem. Consider the situation in which a very few animals are each caused great pain to provide a huge number of people with a very small amount of additional pleasure, and that the total pleasure experienced exceeded the total amount of pain inflicted and hence is

justifiable. Compare this with a situation in which a large

number of animals are caused minimal pain which results in the saving of the life of just one person. The experiments in this

case are not justified because the total amount of pain suffered by the animals is greater than the benefits to the human being

over the remainder of his life.

3.24 Intuitively, people may take the view that the moral

status of the animals in the first case has been undervalued and in the second case overvalued by the utilitarian calculus.

3.25 Utilitarian arguments, as noted earlier, can be used in

defence of human interests at the expense of those of animals. Professor T. Regan, whose arguments for animal welfare are not based on utilitarian considerations, has commented that 'the animal industry is big business' ,10 that employs hundreds of

thousands of people who in total have hundreds and thousands of dependents. Regan argues that a utilitarian must insist on the relevance of these people's interests and also the relevance of

the interests of those additional people who might be affected by 'its sudden or gradual cessation•ll to any calculation which attempts to maximise happiness or minimise suffering. A

utilitarian argument must have the hard data to show that a

humane alternative is not only possible but, judged on

utilitarian grounds, desirable. It is not obviously true that on this basis the consequences for all involved would be better if,

29

for example, animal experimentation were terminated. The

utilitarian approach would require that the interests of those employed who benefited from animal experimentation would in some way be traded off against the interests of the animals used in

experiments.

3.26 By way of reply to this line of argument, Professor

Singer stated in evidence:

I think there are significant costs to any

desirable reform and we have to consider the importance of the reform and meet those costs ... the costs must also be borne in the field

of animal welfare.12

3.27 Professor Singer's form of utilitarian argument offers an apparently clear and simple moral principle, which provides the basis for making decisions about a wide range of issues

arising out of human animal interactions. This line of

argument, particularly its appeal to a single moral principle, was subjected to criticism by Dr Margaret Stone:

there are no simple answers to be found

here and there is no single guiding principle that will answer the questions that are raised about the problems of animal welfare and the use of animals in our society. There have

been, I think, laudable attempts, which have had very many beneficial results, to provide such a principle but they have all failed.

One reason why they have failed, it seems to

me, is that, where ethical principles are

concerned, there is no possibility of proving the validity of an ethical principle and that a single principle does not take account of

what I would see as the competing interests of humans and animals. There is no doubt that

those interests compete, and to try to resolve them with reference to a single principle is to ignore that competition or at least to talk at a level of generality which does not help

us resolve individual problems.

30

If you take Professor Singer's point, not only is his principle in relation to equality no

more logically valid than the exactly opposite principle, that animals and people should be treated unequally, but, even if we accept it

as a working rule, it does not enable us

without further ethical input to answer

specific questions about what we do in any

particular case. So it seems to me that we

have to move on very quickly from that

ill-fated search to find a single principle

and get down to the nitty-gritty of trying to resolve problems that arise in particular

instances.13

Rights

3.28 The other major philosophical theory upon which

attention has been focussed in recent years has ·been that of .

animal rights. The leading exponent of a theory of animal rights has been the philosopher, Professor Tom Regan.

3.29 Professor Regan has contended that it could be claimed

that humans have certain natural rights that animals lack. He posed the question: on what grounds can rights be ascribed to

humans but not to animals? His answer was that rights cannot be claimed on the grounds of reason, free choice or concept of

identity because these cannot be attributed to some humans,

namely infants and the mentally enfeebled . Moreover, even if all human beings possessed rights on these grounds it still would not follow that only human beings possessed them. He posed another question: on what grounds could it be claimed that no animals can

reason, make free choices or form a concept of themselves? His

answer was that the mere supposition that only humans have these capacities could not bear the moral weight placed upon it.

3 . 30 Returning to the issue of rights, if something is a

right, it belongs equally to all humans because they are humans. Professor Regan argued that it cannot be a right if some humans can acquire it by doing something that other humans are unable to do. A right is something all humans have equally .

31

3.31 There is one argument according to Professor Regan that

meets these requirements. Humans have natural rights because humans have interests, and these can be demonstrated wherever choices or preferences are in evidence.

3.32 arguing:

3.33

Professor Regan developed his argument further by

that all humans are the kind of beings that have

rights;

that to cause any human undeserved pain is to treat

him unjustly; and that any time we treat a human unjustly we violate

one of his rights.l4

From this it is inferred that to cause a human

undeserved pain is to violate one of his natural rights - the

right to be spared undeserved pain. This is then a right all

humans have just because they are humans.

3.34 But, if the most plausible basis for attributing a

natural right to be spared undeserved pain to all humans depends on the idea that it is unjust to cause pain to a human, then,

given that it is unjust to do this to an innocent animal, it

follows that animals equally have a natural right to be spared undeserved pain. The assumption as to the injustice of causing undeserved pain to animals is central to the argument.

3.35 In summary, autonomy expressed as an interest in being

spared undeserved pain, commands respect and provides the grounds for the basic rights such as the right to life and the right not

to be harmed. Moral status is therefore grounded in autonomy.

32

Animal Freedom and Other Moral Claims

3.36 There are other approaches to the concept of 'rights'.

It can be argued, for example, that animals have a moral claim to freedom from interference. However, the claim to freedom from interference cannot be absolute. Even humans are constrained from doing something harmful to other humans. Interference with

experimental animals, though, their own self-protection arguments for human liberty

goes well beyond that necessary for or the protection of others. The

need therefore to be examined to

determine their applicability to animals.

3.37 Traditional liberal arguments have held that human

individuality requires a suitable environment for its development in which a principal constituent is liberty; more .Particularly, unique human qualities are developed only through exercising choices. Dr Kleinig in evaluating this position stated:

Animals do not seem to possess a capacity for the kind of "individuality" on which Mill's argument depends. So great is the difference that the case for animals' freedom from

interference is a considerably attenuated one. Animals do, of course, have a certain life of

their own which consists in eating,

reproduction and certain limited kinds of

social behaviour There is often something very fine about

animals in their native habitat, something which is all-too-often lost in confinement. But this, while it may warrant some claim to

freedom from interference, does not come

anywhere near the sort of claim to such

freedom which a human being may assert. Most, if not all, of an animal's life-world can be

accommodated within a relatively confined situation. The requirements that animals have for freedom are nowhere as demanding as those needed for human flourishing.lS

33

3.38 Dr Kleinig argued in his submission that animals have

interests 'whose frustration can be harmful to them' .16 He

further argued that these interests do have some claim to moral consideration but not to the extent that they have equal standing with the interests of humans. The standing of human interests

after all is determined by their amenability to rational

evaluation. The claim of animals to moral consideration means at

a minimum that their interests should not be needlessly

restricted or overridden.

3 .39 An Australian philosopher, Professor McCloskey, has

written a critique of animal rights. He argued that a moral right

is an entitlement that confers moral liberties on its possessor. It is also an entitlement which imposes moral constraints on

others to abstain from interference with the possessor.

Professor McCloskey's position was that it is the capacity for moral autonomy, for moral self-direction and self-determination that is basic to the possibility of possessing a right. Other

beings, whether angels, martians or mice could be ascribed rights if they possessed a capacity for moral autonomy.

3.40 Professor McCloskey concluded that if an animal has the

relevant moral capacities, actual or potential, then it can be a bearer of rights. According to him, while empirical evidence does not provide support for the ascription of rights to animals he

does not rule out the possibility in principle. While primate

research has indicated that a degree of rationality exists among chimpanzees, in his view there is no evidence that they exercise moral judgement. He further argued that different beings may possess different rights because of possession of different attributes. This would create the problem of developing a

hierarchy, or determining the priority, of rights of various

species.

34

Would there be specifically animal rights, tiger rights, pelican rights, tape-worm

rights, if animals were to be capable of

possessing rights? I suggest that any

specifically animal rights are likely only to arise from special needs ot the different

animals, where these are needs that ought to be respected. Thus carnivores, needing to kill other animals in order to live, might be

claimed to have the right to kill these other animals, whereas their vegetarian victims may lack the right to kill other animals except in self-defence, but have the right to eat grass,

leaves, or the like, provided they leave

enough for other animals.l7

3.41 Professor McCloskey in his critique of the concept of

animal rights noted that apart from the possession of rights, there are other considerations:

Typically, the claim that animals possess

rights is seen as adding to and strengthening other important considerations. Thus, even if it could be shown that animals do not possess

rights and are incapable of possessing rights, many other kinds of considerations would need to be explored to determine what constitutes morally proper treatment of animals.18

Clearly, whether or not animals possess

rights, ethically important conclusions

concerning how they ought to be treated would follow if claims that life, sentient life,

conscious life, self-conscious life, possessed intrinsic value, could be sustained Thus just as it might be argued that it is

intrinsically wrong to take innocent human life , so it may be argued that it is

intrinsically wrong to take innocent animal life.19

3.42 Even if some form of rights argument were in fact

established, that, by itself, would not necessarily be the end of the matter.

35

3.43 Dr Margaret Stone, in response to a question as to wha t

sort of rights animals should have, explained:

We already have accepted in this society that animals have interests that need to be

protected and they have an interest in not

being exposed to pain. That is something that has been in our society for a long time. There

have been statutes preventing cruelty to

animals for centuries. If you say to someone, 'Is it right to be cruel to animals?', it

invites, as it should, the answer, 'No, it is

not right'. That is the simple question. The

hard question is when we balance the interests of these animals in not being hurt against the interests of humans in getting this

information. To make the competition more

even, le.t us suppose we have got a disease

that affects only animals, that causes a great deal of pain and suffering to animals in the

wild but never affects people. It does ·not

affect animals that are economically useful to us, but it does affect these animals and it

causes them a lot of pain and distress. You

would then have the question, quite divorced from the question of species, of whether it is right to experiment on these animals in order to protect those animals from pain - the same species, if you like. There you have got

competing interests and no amount of saying that animals have interests full stop will

resolve that question for you. That is because the animals that are subject to the experiment have interests which conflict with the

interests of the animals that are getting

sick.20

3.44 It is important in this context to clarify the

relationship between moral rights and legal rights.

3.45 Originally, talk of rights was confined to the law. What

one had a right to at law, one had a legal guarantee to and the

force of law could be invoked to secure it. But in recent

centuries, rights-talk has been taken over into the sphere of

morality, and there has developed The function of this move has been the notion of a moral right .

to justify the invocation of

legal support for a moral claim. To claim a right is to claim to

36

be in a position to require the forbearance or contribution of

others. Rights justify coercion. That is why they have a special political significance, and why it has become popular to cast the case for animals in terms of rights.

3.46 Given this development the logic behind the concept of

ascribing rights to animals is clear. Dr Kleinig stated in

submission:

Those who wish to improve the lot of animals

probably need to have their concern enshrined in law. The reason for this is fairly obvious. Certain kinds of mistreatment are deeply

embedded in our social practices, and closely tied up with economic factors. Change is not likely to come about voluntarily, or simply as the result of moralizing. This is a case where morality requires some form of legal

But how to secure that backing in a democratic community? If it can be argued that animals

have rights, and that these are being violated by current practices, then the battle is half won.2l ·

3.47 There has been extensive debate over the derivation of

rights; are they discretionary powers, that is, claims against others which may be 'assented or waived, insisted upon or set

aside'22 or they rights based upon the possession of

interests? It was argued by Dr Kleinig that rights possession:

... does not require anything so strong as the

capacity for rational choice, and therefore that a case can be made out for ascribing

rights to animals.23

Kleinig thought that his point of view represented a minority position in the debate on this subject.

3.48 Further, if animals qualify as rights holders they have

'very powerful claims•24 to moral, and as a consequence, legal protection. If animals do not qualify it does not mean that they lie outside our protective concern, but that human beings as

37

rights-holders will take precedence over non-rights-holders. In addition, acknowledgement of animals as rights-holders does not rule out the possibility that they may have fewer and different rights vis-a-vis humans, such as a very qualified right to life, to freedom from suffering and to quality of habitat. Such rights will inevitably come into conflict with human rights but they can

be ordered by examining and weighing the relative importance of the interests underlying them.

3.49 On the relationship between legal and moral rights,

Dr Kleinig expressed the view:

3.50

that one can argue for moral rights on

behalf of animals, though they are perhaps not as extensive or as compelling as the moral

rights that attach to human beings. But it

does seem to me that animals have claims,· by

virtue of the kinds of welfare they have,

which are strong enough to justify enforcement at law. For me, that constitutes their having a moral right to those particular claims.25

When asked whether moral rights should be enforceable by statute, he responded:

3.51

Moral rights constitute a case for

enforcement, in my view. They constitute

moral grounds which are strong enough to

justify intervention of a coercive nature. It may be by legal statute or by other means.

Coercion is not the exclusive province of law, of course, but it is perhaps the main

source.26

When asked whether it was appropriate to say that

animals themselves have legal rights, Ms M. Stone responded that it was:

Entirely appropriate, and we have already done that.27

38

3.52 If this view is accepted, the issue is not whether or

not animals have rights but which rights will be granted and who will have standing to ensure that such rights are enforced.

Animals and Equality

3.53 The question of relative status necessarily invokes the

question of equality of rights. Here the argument from marginal cases has been advanced. This argument holds that the

distinctions between human species and other species are not as clear as is commonly assumed. In particular, infants, the

severely intellectually handicapped and, possibly, the comatose, have capacities and abilities which are more limited than those of the 'higher' animals, and therefore equality. of treatment should be extended to animals. Dr Kleinig commented in evidence that:

My own worry about the argument from marginal cases is that it tends to overlook on the part of human beings the potentiality for

development which humans have and which, I

think, most, if not all, the higher animals do not have ... Human infants do have a capacity

to develop into morally responsible and

sensitive beings and I think that this

potentiality, as it were, reaches back into

infancy and determines the appropriate ways for treating those who are still in their

infancy.

In the case of retarded people, we obviously need to distinguish between different degrees of retardation. Some retarded people obviously have a great deal of potential for development of moral and other sensitivities. In the case of the extremely severely retarded, it may be that there is no absolute distinction which can be drawn between their positions so far as capacities are concerned and the capacities of some of the animals. There are, however, I

suspect, strong social policy reasons f0r

drawing a distinction there, which includes those retarded people within the protections

39

that we give to other human beings, namely,

that if we do not draw the line below them,

then the borderline will be an arena for

various kinds of abuses of those people.

Again, that is not to say ... that means that

the distinction between humans and animals is such that we can do what we like to animals,

but should not do that at all with human

beings. That certain humans are, perhaps,

accorded protections beyond those which would be justifiable in terms of their capacities is not a reason for treating as we wish those who do not have that protection . 28

3.54 A further objection has been advanced by Dr Margaret

Stone who commented that equal consideration of interests i s simply an assertion of values which can neither be proved nor

disproved:

Singer declares that the duty not to exhibit a preference for a particular species must

prevail over the duty to promote human

interests; yet this is no more or less valid

than the converse assumption, that human

interests take precedence.29

3 . 55 By giving primacy to one value, equality of

consideration of interest, there is a refusal to recognise a

'tragic choice'. In this case it is the choice between the

competing and profound moral values, between the duty to respect the interests of humans and the duty to respect the interests of animals.

3.56 As Professor Les Holborow noted, the history of

increasingly stringent animals suggests that regulation and legislation to protect the generally accepted view has been

towards an increasing recognition of the claims of

The problem remains of attempting to balance the

shifting animals. competing claims.

40

3.57 Professor Holborow supported an approach based on

rights. He stressed, however, that rights as he understands them are not absolute but are better understood as side constraints 'because they impose powerful restrictions on what agents may do to others' .30

3 . 58 What has been established by the philosophical debate

reviewed here is that at a minimum, the autonomy and capacity to experience distress that animals possess in varying capacities, are enough to ensure that humans as moral agents have real and

important obligations and duties to them. According to Dr Arthur Caplan:

Human beings bear the burden of being

responsible moral stewards for respecting and protecting the interests and welfare of those creatures which are alive and do have

minimal levels of sentience .. .

Both the capacity for a full mental life and

the ability to suffer place demands on the

responsible moral agent that are sufficient in themselves to demand compliance and discharge. Animals deserve no less respect than that

which we accord the most helpless and

vulnerable members of our own species.31

Conclusions

3 . 59 The autonomy and clearly demonstrated capacity of

animals to experience pain, though varying in degrees, is enough to establish that human beings, as moral agents, have real and

substantial obligations and duties toward them. -Anyone involved in the use of animals for research purposes is therefore

accountable to the wider community for the performance of those duties.

41

3.60 Through animal cruelty, wildlife protection and othe r

legislation, society has acknowledged that animals, whether as individuals or species , have certain claims or interests which may be expressed as rights, that are afforded protection. Such rights are not inviolable. When rights of animals come into a

conflict with those of humans, the rights of one will normally succumb to the other . Although human rights have usually

predominated in such conflicts, each case should be examined on its merits and human rights should not automatically prevail .

42

CHAPTER 4

ANIMAL PAIN AND DISTRESS

Definitions

4 . 1 Discussion of pain presents difficulties o f b o th

defin i tion and communication. Some of the difficultie s were

outlined by Dr M. Rose, Chairman of the Animal Research Revie w

Panel of New South Wales:

4 . 2

I think it is important to note that in

relation to pain we tend to use four terms .. .

'pain', 'suffering', 'anxiety', and 'stress' . The interpretation of those words depends very much on whether you are talking to

physiologists, psychologists, behaviourists or philosophers - they all seem to interpret this sort of terminology differently. I think this language problem with pain is one of the most difficult things ... 1

The International Association for the Study of Pain defined pain as:

4 .3

an unpleasant sensory or emotional

experience associated with actual or potential damage or described in terms of such damage.2

A similar definition is contained in a report to the

European Commission:

Pain is an unpleasant sensation that is

perceived as arising from a specific region of the body and which is commonly associated with actual or potential tissue damage, or

communicate in terms of such damage.3

43

Communication in this context includes signals and non-verbal communication.

4.4 The simplicity of this -definition may be misleading. It

is necessary to emphasise the fact that there are two distinct

aspects to be considered in evaluating pain stimuli and

perception. There is not a simple one to one correlation between the two. The same amount of stimulus will not cause identical

perceptions of pain by animals of different species, nor

will it necessarily do so for different animals of the same

species. This is explained in the introduction to an anthology of research reports on animal pain:

Most authorities agree that pain is a

perception, not a physical entity, and that

perception of pain depends on a functioning cerebral cortex. Unlike most other sensations, no single area of the cerebral cortex seems

specifically necessary for the perception of pain. The term noxious describes stimuli that, if perceived, give rise to the perception of

pain ... The receptors specifically responsive to noxious stimuli are termed nociceptors. A stimulus must be a certain strength before a nociceptor will generate nerve impulses in peripheral nerve fiber of which it is a part.

This stimulation strength is called the

nociceptive threshold. In certain

circumstances this amount of neural activity may be too little to result in perception of

pain. The strength at which noxious

stimulation is perceived by a human being as pain is referred to as the pain detection

threshold. The strongest intensity of noxious stimulation that a human being will permit an experimenter to deliver is called the pain

tolerance threshold. The strength of noxious stimulation necessary to reach the nociceptor threshold is rather constant and varies little among humans and animals. The strength needed

to cross the pain detection threshold is

slightly more variable, especially among

humans experiencing clinical pain. The pain tolerance threshold is the most variable of the three thresholds.4

44

4.5 To understand the perception of pain as a sensation

requires constant reference to both the sensory functions of the nervous system and the anatomic or physiological organisation of an animal . In humans pain is further linked to the emotions

through the functioning of information from the outside the brain which integrates it with world and results in behavioural responses.

4.6 Pain can be divided into two categories: quality, which

ranges from mild to severe; and temporal, either acute or

chronic . The temporal category can be broken down further into causation, impact and treatment.

4 . 7

Acute Pain results from a traumatic,

surgical, or infectious event that is

abrupt in onset and relatively short in

duration. It is generally alleviated by

analgesics. Chronic Pain results from a long-standing physical disorder or emotional distress that is usually slow in onset and has a

long duration. It is seldom alleviated by analgesics but frequently responds to

tranquillizers combined with environmental manipulation and behavioural conditioning.S

The term 'anxiety' is also used in connection with

animal behaviour. There is some evidence that vertebrates at least are able to experience similar to that seen in

a physiological

humans. Brain form of anxiety receptors for

benzodiazepine have been found in mammals, reptiles, amphibians and bony fish but not in invertebrates.

4.8 The term 'suffering' is commonly used in relation to

animals. It is often paired with the term pain in an attempt to

indicate that the well-being of animals is not simply a matter o·f freedom from pain.

45

4. 9 There are, however, difficulties with the term.

Suffering is even more difficult to define than pain. It covers in humans a wide range of mental or emotional states. Fear,

hunger, suffering. boredom, frustration and Suffering then involves

grief may

a scale or

all indicate

continuum of

unpleasant experiences that vary in intensity.

4.10 The Committee does not find the use of the term

'suffering' to be very helpful. There is presently no agreed

definition of suffering that would provide guidance to ethics committees and experimenters. The concerns with animal well-being that are not directly related to pain are more appropriately

described by the term 'distress'.

4.11 In coming to an understanding of 'distr;ess' we need

first to consider the nature of 'stress'. Stress may be simply a normal healthy reaction to changes in an animal's environment or metabolism, for example, injury, disease or exposure to extremes of temperature. If stress were prolonged because the

physiological response was not able to adapt to the changed

conditions, a stage of exhaustion would be reached, characterised by impairment of those body functions involved in growth,

reproduction, resistance to disease and general activity. The problem is deciding when stress becomes distress.

4.12 In the draft revised Code of Practice, 'distress' is

defined as:

4.13

Acute or chronic response of an animal caused by stimuli that produce biological or

psychological stress to which the animal

cannot adjust by normal physiological or

behavioural means.

The EC report defines chronic stress in animals as:

a feeling related with the entire process of emergence of pathologies

46

ulceration of digestive tract; behaviourally: stereotypes and redirected behaviour>.6

Scientific Attitudes to Animal Pain

4.14 The willingness of the scientific community to consider whether animals experience pain let alone anxiety seems to have been influenced as much by the philosophical assumptions of their age as by the findings of research on the subject. Pain

researchers Kitchell and Erickson presented the following view based on the current state of research into pain:

When considering pain in animals, analogies must be drawn between human and animal

anatomy, physiology, and behaviour. Knowledge about pain in animals remains inferential, however, and neglect of the probabilistic

nature of pain perception in animals leads to anthropomorphism. On the other hand,

overemphasis on the uncertainty of our

knowledge about pain perception in animals, which leads to a denial that pain perception exists in animals, is logically as well as

empirically unfounded. That tacit assumption is that stimuli are noxious and strong enough to give rise to the perception of pain in

animals if the stimuli are detected as pain by human beings, if they at least approach or

exceed tissue-damaging proportions, and if they produce escape behaviour in animals.?

4 . 15 This represents a balanced if cautious view on the

issue. Changing views on the reality of animal pain in recent

years have resulted from both advances in physiology and changes in philosophy which now allow for the possibility that animals experience some form of consciousness.

4.16 There was substantial agreement among the experimenters appearing before the Committee as to the reality of animal pain. According to Professor Egerton:

47

4 .17

My belief is that we should approach this

question from the basic premise that at least vertebrate animals suffer pain. I cannot

really argue about the level to which they

suffer pain and their appreciation of that

level. I know that the mechanisms are

available in vertebrate animals sufficient to receive pain messages. They have brains that are sufficiently developed to make them

appreciate those pain messages that they get from injured parts of their bodies . B

Although in basic agreement, Professor Titchen sounded a note of caution:

4.18

one should remain aware of the fact that

we make a number of assumptions, that is, that the receptivity for pain in animals is the

same as or similar to that in humans . There is

some supporting electrophysiological and neurophysiological evidence for that, but beyond that point, once we leave the issue of reception and we start into the area of

perception and sensory appreciation of pain, our evidence is flimsy in the extreme . Indeed, there is some anatomical evidence which does not support the idea that the same pathways

for pain exist in all animals as in humans

9

Dr M. Rose pointed out to the Committee that there is a relationship between pain context in which the pain pain is heightened when

perception and the environment or is inflicted. A person's perception of pain is expected compared with pain

caused by an accident. She went on to say that there is evidence that this also occurs with animals.10

4.19 Mr Richard Ryder of the United Kingdom, who appeared for the Australian Federation of Animal Societies Cnow ANZFAS) , agreed that animals and humans both experience pain in similar ways. He added:

Dr Kelly and others in Britain and elsewhere have discovered the chemicals that seem to be associated with the transmission of pain in

48

the central nervous system and have found that these chemicals are present in all the major classes of animals, including fish.11

Difficulties in the Assessment of Animal Pain and Distress

4.20 The assessment of whether animals are experiencing pain or distress is often difficult since it is mostly done on the

basis of indirect evidence. Criteria for assessment of animal well-being include:

physical health;

(b) behaviour of animals in the wild; (c) physiological measurements such as heart rate and hormone levels; abnormal behaviour patterns;

(e) animal preferences; and anthropomorphism.

These criteria, in many cases, cannot be used to make definitive statements about the level of pain or distress experienced by an animal. At best, they can give an indication of such suffering.

4.21 Disease and injury are major causes of distress and

their absence is necessary to an animal's well-being. Animals may still suffer distress despite an appearance of good health.

According to M. Stamp Dawkins:

4.22

The occurrence of physiological and

behavioural disturbances in apparently healthy animals suggest that other methods of

assessing suffering should be looked for.l2

Some people may try to draw inferences about the

well-being of confined animals by means of comparisons between animals in restricted environments with those of the same species in wild or semi-wild conditions. However, genetic and

49

environmental differences between wild and domesticated animals make comparisons difficult. A difference in the behaviour of free and restricted animals in itself does not automatically mean that the restricted ones are distressed. Distress must be established

by independent means.

4.23 The problem of physiological measurements such as heart rate and hormone levels is to decide how much of a physiological change an animal can tolerate before it can be said to be

distressed. The taking of physiological measurements may also be stressful to an animal and this additional stress may distort the results.

4.24 With abnormal behaviour patterns, the question to be

asked is: when does such behaviour constitute distress? Some abnormal behaviour clearly indicates distress because visible physical damage is done to the animal. However, abnorma l

behaviour often does not reach that level.

4.25 One method of research into stressful environments is by establishing animal preferences. This involves giving animals the opportunity to choose for themselves which environments they prefer. Animals may choose, however, an environment with which they are familiar rather than a 'better' one which they have not experienced. The results may be different if the animals had been raised in different conditions.

4.26 Anthropomorphism in the interpretation of animal

behaviour should only be used in association with behavioural or other scientific information on the animals concerned. It is

nevertheless very difficult to make judgements which avoid at least some degree of anthropomorphism.

50

Animal Pain Assessment

4.27 British veterinarians have developed a series of species specific assessments that enable the extent of pain being

e xperienced by an animal to be defined in a general way. The

e lements involved in this assessment include:

behaviour indicating pain, distress and discomfort:

posture, vocalising, other behaviour; temperament, locomotion and common clinical signs: cardiovasc ular, respiratory,

digestive, nervous and musculoskeletal,

miscellaneous.

These elements are in addition to any changes in and

food and water intake.

4 . 28 Not all of the signs may be present simultaneously and

no sign by itself is indicative of the degree of pain

e xperienced. The scheme involves measuring or assessing a number

of independent variables: bodyweight, appearance, clinical signs, unprovoked behaviour and responses to an appropriate stimulus.

Scores of 0 to 3 are assigned to each of these

variables in an animal ... While more precise

quantitative assessments would be preferred this is not possible. Consequently, one has to try to group clinical observations into broad categories and the following have been

assigned for this purpose: No obvious

deviation from the normal range; possibly

abnormal, ie, minor change; a definite change from normal but not marked; and a gross change from normal .

Scores of 0 to 3 are assigned to these four

groups with 0 given when no abnormal variation is detected.13

51

4.29 The broad categories of pain assessment and necessary

action are set out in Table 4.1.

Table 4.1: Possible Interpretation of Total Scores from an Overall Assessment of an Experimental Animal

Total Score Overall Assessment

0 to 4

5 to 9

10 to 14

15 to 20

Normal

Monitor carefully, should consider the use of analgesics and sedatives

Ample evidence of suffering, some form of relief must be seriously considered; should be under regular observation; seek expert advice; consider termination

Relief should be given, unless the animal is comatose. Is it a worthwhile experimental animal because physiologically it is likely to be abnormal? There is ample evidence of severe pain. If likely to endure, terminate the experiment.

SOURCE: 'Guidelines on the Recognition of Pain, Distress and Discomfort in Experimental Animals and an Hypothesis for Assessment', by P. H. M. Griffiths, Veterinary Record (April 20 1985, Vol.116, pp.431-436>

4.30 Such a scheme is species specific and requires a

detailed knowledge of many dimensions of the normal behaviour, diet and metabolism of each species. It is particularly relevant for post-operative care as well as monitoring during non-invasive experiments. However, David Adams, an Australian expert in pain research, warned:

Words such as 'measurement' and their like

have limited application to pain. They imply the possibility of a system for ranking pain and a single universal formula for reckoning its severity. Pain is a perception in the

physiological sense of the word and varies

52

both in quality and intensity. Pain is

'pluridimensional'. A scale of severity would be spurious and, more importantly,

inconsequential to pain relief or prevention. Pain is better categorised according to the action necessary to alleviate it. Diagnosis as opposed to measurement is implied here.14

4 . 31 The alternative approach to assessing animal pain is to

grade the experimental techniques upon the basis of what is known about the techniques, the extent to which they are invasive,

their length, degree to which analgesia is necessary etc. Dr A. Rowan provided a model for such a classification in Table 4.2.

53

Table 4.2: Research Techniques, Pain and Distress

Categories

1. No pain or only minimal and momentary pain

2 . Animals painlessly killed or anaesthetised animals not allowed to recover

3. Surgery on anaesthetised animals with recovery but where postoperative pain will be minimal

4 . As above but with

considerable postoperative pain

5. Experiments planned on unanaesthetised animals expected to become seriously ill from the treatment or to suffer considerable pain or distress 6. Experiments on

unanaesthetised animals where the animal is curarised or paralysed

Examples

Injections*, blood samples, tube-feeding*, diet experiments*, breeding studies, behavioural studies without aversive conditioning, routine procedures from small animal vet. practice Blood pressure studies, organ and tissue removal, studies on organ survival, perfusion experiments

Biopsies, transfusion or vascular studies, cannulation, castration, pituitary removal in rodents using s 'tandard techniques, some CNS lesions

Major surgical operations, burn studies, graft studies

Toxicity testing, radiation, transplants of tumours or infections, stress, shock or burn studies, behaviour experiments involving aversive conditioning

Some physiological or pharmacological studies on CNS

* These procedures may produce pathological states

injection of pathogens, feeding of toxic chemicals> and, if so, would have to be graded differently.

SOURCE: Dr A. Rowan, 'Of Mice, Models and Men', State University of New York, 1984, p.82.

54

Pain Classification System

4.32 There has been some debate in Australia whether the Code

of Practice should include a pain classification system that

would require researchers to specify in their protocols in which pain category their experiments would fall. It has been argued that a pain classification system would enable ethics committees to give special consideration to experiments which fall into the

more severe categories of pain. It would also identify for

non-scientist members of ethics committees those experiments which caused more than mild pain or suffering.

4.33 Although a pain classification has some benefits,

it has administrative problems and may bring about some

undesirable practices.

4.34 There is the obvious problem of deciding in which

category to place an experiment. It is inevitably a subjective decision even with documented criteria to assist experimenters in their decisions. It is also human nature to downgrade the

severity of an experiment, particularly in cases where the level of pain is difficult to determine.

4.35 In a series of experiments, different levels of pain and

suffering may be experienced by the animals. Should the

categorisation be on the basis of the most painful, the least or the average? One painful experiment in a hundred may distort the categorisation if the most painful experiment forms the basis of categorisation. If the average is used, it may hide a few

excruciating experiments amongst many mild ones.

4.36 Professor Taylor of the University of Sydney commented:

I cannot see the advantage of such a scheme.

In the first place, I think any sort of scale

would be extraordinarily difficult to devise

55

and agree on so that it became

common consent all over Australia internationally that a grade meant exactly the same thing.

sort of agreement a scale

meaningless.lS

a matter of

and, indeed, 2 experiment Without that would be

4.37 A pain classification system concentrates attention on the severe end of the scale and diverts attention from the other end. An experiment which causes any pain at all should be

scrutinised carefully by an ethics committee. Even minimal

amounts of pain should not be disregarded. The questions that should be asked of all experiments are whether animals need to be used at all and, if so, whether there needs to be any pain or

distress. Experiments which fall in the lower end of the scale

should not be disregarded as unimportant because they account for most of the animals used.

4.38 Professor Dorsch, Pro-Vice-Chancellor of the University of Sydney, argued:

4.39

It would be

positively counterproductive ... If an ethics committee gives you a grade 2 for pain, you

think, 'I am not doing anything very painful so I do not really have to take much care of

these animals'. It takes out the individual

care and the individual responsibility for the experiment. So I think that sort of artificial scale, firstly, is difficult to establish and, secondly, would probably lead to less care

than the responsibility being right there for looking at the animal and establishing whether it is suffering pain and discomfort.l6 Dr Rose, in her capacity as Chairperson of the New South Wales Animal Research Review Panel, expressed the view that a pain classification scheme engenders a belief among experimenters

that minimal pain in animals is acceptable and does not have to be treated or monitored.l7

56

4. 40 The level of pain or distress caused by an experiment is

often determined by the experience and competence of the

experimenter. Dr Hampson illustrated this point in her evidence by showing that one experimenter can keep distress to a minimum

by . Proper and caring techniques while another experimenter will

cause significant distress to the animal while conducting the same experiment.l8

4. 4 1 In evidence to the Committee, Dr W. Anderson,

representing the NHMRC, said that pain categories might be useful for statistical purposes, referring, by way of example, to the co llection by the Victorian Government of statistics on types of

experiments.l9 This use of pain categories is subject to the same problems as those inherent in the use of categories by ethics

committees. Such categories are only useful if they can be

defined in such a way as to make the statistics meaningful.

However, because classifying pain is so subjective and defining categories is so difficult, the Committee can see little purpose

in including pain categories in statistics on animal

experimentation.

4 . 42 Apart from the severity of pain, there are other factors

to be considered, such as the duration of the pain and the types

of procedures being used. Then there are other forms of stress or anxiety occurring either during or after an experiment which might not be painful but might be more distressful to the animal than pain itself. An experiment might, for example, result in

paralysis of part of the body or in the impairment of some bodily function. This might be more distressful to the animal than being subjected to pain.

4.43 The draft revised Code of Practice states:

The AEEC may adopt or

develop a system to categorise experiments, to help identify areas of special concern.20

57

4.44 Although this provision in the draft Code of Practice

does not specifically require the adoption of a pain

classification scheme, it is couched in a way to suggest it is

preferable to establish one. The Committee believes that its

adoption will not serve the interests of animal welfare.

Pain Relief in Laboratory Animals

4.45 Despite the difficulties outlined in measuring and

assessing pain as experienced by animals, the need for pain

relief in animals used for experimental purposes is clear . Dr P. Flecknell, a leading expert on analgesia and anaesthesia, has outlined the basis on which experimenters should consider relief of pain.

4.46

Until further progress is made in assessing the nature of pain in animals, it should be

assumed that if a procedure is likely to cause pain in man, it will produce a similar degree of pain in animals. Although such

anthropomorphic views have been much

criticized, no satisfactory alternatives have so far been proposed, therefore the relief of pain, particularly in the postoperative

period, must be considered essential.21

According to the same author:

Anaesthesia is a relatively neglected area of laboratory animal science. Many of the

advances in technique which have been

introduced into human clinical anaesthesia have been largely ignored by research workers and, at the time of writing, ether and

pentobarbitone remain the drugs which are most widely used for anaesthetising laboratory animals. As will be discussed later, both of

these drugs have serious disadvantages as

anaesthetics, and they are generally better replaced by other agents.

58

4.4 7

A second common failing of current laboratory animal anaesthetic practice is the lack of

consideration given to the pre- and

post-operative care of the animal. Careful

attention to the needs and well-being of the animal during these periods should be

considered an integral part of the

anaesthetist's responsibilities. Not only will such attention do much to prevent the animal from experiencing any unnecessary pain and distress, it will also considerably reduce

anaesthetic mortality and hasten

post-operative recovery.22

Control of

of analgesia. Good

a ppropriate areas

pain extends well beyond the administration surgical techniques and provision of

for recovery from anaesthesia and for

post-operative nursing are also important.

4.4 8 There is

experimenters developments to

a need for continual in-service training of assist them in keeping up to date with

in anaesthesia and analgesia. Few opportunities for training in this area are currently provided in Australia.

Pain in Codes of Practice

4 .49 The draft revised Code of Practice contains the

f ollowing general principles on the infliction of pain on

experimental animals and the use of anaesthesia and analgesia:

1.12 Experiments must be designed to avoid

pain or distress to animals. If this is not

possible, pain or distress must be minimised.

1.13 Pain and distress cannot be easily

evaluated in animals and therefore

investigators must assume that animals

experience pain in a manner similar to humans. Decisions regarding the animals' welfare must be based on this assumption unless there is

evidence to the contrary.

59

4.50

1.14 Experiments which may cause pain of a

kind and degree for which anaesthesia would normally be used in medical or veterinary

practice must be carried out using appropriate anaesthesia. When it is not possible to use

anaesthesia, such as in certain toxicological or animal production experiments or in animal models of diseases, the end-point of the

experiments must be as early as possible to

avoid or minimise pain or distress to the

animals .

1.15 Investigators must avoid using death as an experimental end-point whenever possible.

1.16 Analgesic and tranquillizer usage must be appropriate for the species and should at

least parallel usage in medical or veterinary practice. 1.17 Animals which develop signs of pain or

distress that are more severe than is

acceptable in medical or veterinary pract'ice must have the pain or distress alleviated

promptly or be killed humanely without delay. Alleviation of such pain or distress must take precedence over finishing an experiment.

Sections 3.3 . 1 to 3.3.15 of the draft revised Code of

Practice set out the specific steps necessary for these general principles to be implemented. Emphasis is placed on monitoring animals for signs of pain and distress. The approach taken draws heavily on the work of Morton and Griffiths discussed earlier in this chapter.

4.51 In its discussion of pain and anaesthesia, ANZFAS

recommended to the Committee:

That no procedure be permitted which may cause pain or, suffering , of more than trivial extent unless -i> appropriate analgesia or anaesthesia is

administered including during any period of post-operative care, or

ii> other refinements are utilized,

to eliminate the potential for such pain or

suffering.23

60

4.52 This is a more restrictive form of the requirement in

the current Code of Practice which requires that:

4 . 5 3

Procedures which are liable to cause pain of more than trivial extent, or those other than of a routine husbandry nature carried out in accordance with accepted farming practice, must not be carried out without anaesthesia which is adequate and appropriate for that

species of animal and is administered for the duration of the procedure.24

The relevant provision in the draft revised Code of

Practice is:

4.54

Experiments which may cause pain of a kind and degree for which anaesthesia would normally be used in medical or veterinary practice must' be carried out using appropriate anaesthesia.25

ANZFAS made the following observations about the

proposed new provision:

the existing, pain threshold of 'more

than trivial extent provides a higher standard of animal welfare than does the proposed

threshold of normal 'medical and veterinary practice'; the normal treatment of a human or an

animal in a medical or veterinary practice, where the object of the treatment is for the

benefit of the individual concerned, should not apply as the standard in circumstances

where the animal is subjected to pain or

distress as part of an experiment; the experimental animal subjected to levels of pain

unacceptable to healthy human similar experiment;

should not be

that would be

volunteers in a

(iv> the existing pain threshold of 'more

than trivial extent ' provides a clear,

unambiguous guideline of the circumstances in which anaesthesia and analgesia are prescribed

61

4 . 55

by the Code. By contrast the proposed

threshold is loosely worded, and subject to

variable interpretation. There is ambiguity as to whether veterinary practice includes

procedures of a routine husbandry nature . 26

Central to the ANZFAS case is the assertion that the

concept of ' pain of more than trivial extent' provides a 'clear

unambiguous guideline' for the level of pain which requires

a naes t hesi a . Professor Singer commented:

I have understood this is to mean the kinds of

pain that one would inflict on humans without too much thought. For instance, giving an

anaesthetic itself will involve an injection and that may cause some momentary pain. But I would consider that to be pain of a trivial

extent and something that could be justified. The same may be true of drawing a bl.ood

sample . Again, that is something that would be done in humans without the use of an

anaesthetic.27

4.56 However, as Dr Hampson pointed out in evidence, the

givi ng of an injection may cause distress if the animal is not

handled properly by the experimenter .

4 . 57 Dr Gleeson, the Executive Officer of the ethics

committee at La Trobe University, emphasised the subjective nature of this concept. Asked to define it he replied:

I cannot really define it for everybody else

but in my mind I would, perhaps, know what

trivial is to me. In my experience at La

Trobe, I find the experiments there to be

pretty non-invasive and whilst for some of

them you may not use the word trivial, I think that the amount of pain involved is small and the animals were always closely monitored so that if it does get beyond a particular, again threshold, something can be done

about it.2tl

62

4.58 Given the subjective nature of the 'trivial extent'

option there can be no guarantee that it will lead as the first

part of the ANZFAS comment suggests to a higher standard of

animal welfare than the proposed alternative.

4.59 The variability of the human pain threshold also casts

some doubt on the usefulness of the test proposed in part

of what would be acceptable or unacceptable to healthy human

volunteers.

4.60 The proposed wording in the draft revised Code of

Practice is an attempt to establish a more objective basis for decision-making by ethics committees. However, the reference to medical and veterinary practice needs to be tied more closely to specific species. What is acceptable practice for species may not be for another species. The spaying of cattle in remote areas

of Queensland, for example, is routinely done without

anaesthesia. Surgical interventions of a similar nature conducted on companion animals would normally be done under anaesthetics.

4.61 The Committee prefers the following wording instead of

that which is contained in the draft revised Code of Practice. It ties veterinary and medical practice closer to specific species and procedures.

Experiments which may cause pain of a kind and degree for which anaesthesia would normally be used in the area of medical or veterinary

practice most closely related to the proposed procedure and species, must be carried out

using appropriate anaesthesia.

4.62 What both definitions (that is, Code of Practice and

ANZFAS> point to is the shared moral consensus within the

community which acknowledges that animals are not to suffer pain above some fairly minimum level. The definitions in the Code of Practice are there to guide experimenters in the planning of

projects and assist the ethics committees in their assessment of them.

63

4.63 Inevitably, a decision by an experimenter or an ethics

committee whether to use anaesthesia will be subjective,

irrespective of which definition is used in the revised Code of Practice. Whatever wording is adopted, the meaning is clear:

minimal pain only will be acceptable to the community and to the authorities which sponsored the revision of the Code of Practice. Where tightly defined terminology is impossible by virtue of the subjective nature of the topic, the spirit of the regulatory

provisions overrides any interpretation of the actual words used in the regulation. The intention of the Code of Practice is clear and it is the intention which is paramount in the interpretation of the provisions of the Code of Practice in this subjective

area.

64

CHAPTER 5

THE USE OF ANIMALS IN BIOMEDICAL RESEARCH

Int roduction

5.1 In this chapter, the Committee examines the arguments

f o r and against the use of animals in biomedical research. The

arguments used also apply generally to the use of animals in

e xperiments. Issues specifically related to other forms of animal

experimentation are examined in succeeding chapters.

5.2 During the course of the inquiry, the Committee received

a wide spectrum of views on the value of and justification for

t he use of animals in experiments. Some opponents of biomedical

research or animal experimentation in general advocated an

immediate ban on experiments; others supported the phasing out of animal experimentation as alternatives to the use of animals become available. There were other people, again, who wanted to reform the conduct of experiments on animals but who did not see

the abolition of such experiments as a possible option, at least for a long time.

5.3 It would be true to say that all people would like to

abolish experiments on animals, provided that there were suitable a l ternatives available. No-one likes to kill sentient beings or

cause pain or distress to them. However, the scientific community argued that, at the current stage of technological development, it is still dependent on the use of animals in the conduct of

biomedical research.

65

5.4 Besides philosophical arguments, which were discussed in Chapter 3, critics of the use of animals in biomedical research focussed on the following issues:

· scepticism or actual rejection of the value of animal experimentation for human medicine and the questioning of the adequacy of particular animal models of huma n disease;

· the unnecessary repetition of experiments;

• the distortion of experimental results as a

consequence of the unnecessary pain and distress of the animals undergoing experiments.

Value of Biomedical Research

5.5 The Australian Association for Humane Research

argued for the immediate cessation of experiments on animals. It questioned the efficacy of animal experimentation and suggested that:

5.6

... animal experimentation is not only leading modern medicine further and further away from the goal of health, but the data obtained from animals has even proved dangerous on more than one occasion.l

Mrs E. Ahlston, representing the AAHR, told the

Committee:

That there is absolutely no correlation

between animal experiments and improvements in health can be illustrated by the fact that

America, with an estimated 100 million animals dying in laboratories each year, has been

placed 17th on the World Health Organization's list of healthy nations despite the

sophisticated technology of its medical

services. A knowledge of medical history

provides further proof.2

66

She went on to say:

5 . 7

An animal 'model' mimicking human disease in the artificial environment of a laboratory can never reproduce the complex factors of the

human lifestyle and, without these components, the study of the disease process artificially produced in animals is of little, if any,

value.3

In an earlier hearing in 1984, Mrs Ahlston denied that many advances in medical science have been made as a result of

animal experimentation.4

5.8 The views of the AAHR were disputed strenuously by

proponents of animal experimentation throughout the inquiry. They argued that biomedical science, largely dependent on animal experimentation, has made many advances over the last century in developing cures for diseases and for the relief of pain and

distress. They went on to say that although alternatives were being introduced, the use of animals would still be essential for biomedical research in the forseable future. According to

Professor Darian-Smith:

... we are not at a stage where we can ease up

on biomedical research. We are right at the

beginning of all the really difficult testing. Relatively, the simple questions have been resolved. They may not have been simple in

terms of the social implications but

biologically they have been relatively simple. The real questions, the real problems, will

confront us in the next 50 years.S

5.9 The role that community expectations play in justifying

research was taken up by Dr Campbell:

The community expects continuing advancement in health benefits to it. A good example of

this is perhaps the recent occurrence of AIDS in which there is a strong demand from the

67

5.10

community at large for a cure for AIDS to be

found. It is the best example that comes to

mind of where the community demands research to be performed and demands an outcome that is satisfactory to the health of the community. Research into AIDS ... will depend a lot on

the use of animals.6

The Committee is convinced of the value of animal

experimentation in the area of biomedical research, both as a result of past discoveries and of the potential to find new cures for diseases for which there is currently no or little treatment available. The evidence put before the Committee in submissions and at hearings and the information contained in the scientific

literature clearly demonstrates the important role animal

experimentation has played in the development of treatments for many diseases which once were the scourges of people and animals

throughout the world.

5.11 Having said that, it should not be taken that animal

experimentation or, in fact, biomedical research itself, is the panacea for all the ills of humans and animals. As ANZFAS pointed out in its submission, many of the world's fatal diseases are to a large extent caused or exacerbated by environmental conditions

and lifestyles. Control of these diseases is often in the hands of humans themselves. Much can be done to reduce the incidence of heart disease, cancer and strokes without resort to biomedical science. In many cases, biomedical science has little to offer by way of cures.

Use of Animals in Basic Research

5.12 Stronger opinions were held in the evidence on the use

of animals in basic or fundamental research compared with applied research. In its submission, ANZFAS commented that:

68

5.13

Fundamental research is not goal-oriented and the application of any knowledge flowing from it cannot be predicted in advance. While it is acknowledged that some fundamental research may lead to important and unforseen

breakthroughs and applications, there is a tendency on the part of the scientific

community to over generalise from a small

number of particular examples. Most

fundamental research leads to no benefits

whatever. Often it is carried out for

postgraduate projects, or because of pressure to publish, or because grants happen to be

available. A great deal of research is low

grade and is never published at all.?

ANZFAS went on to recommend that legislation be enacted

to ban all experiments in basic research which caused pain or

suffering.

5 .1 4 Professor Boura of Monash University commented that when scientists are working on the peripherary of existing knowledge, they cannot accurately predict the results of research. He went on to describe how experiments on a non-addictive analgesic

accidentally revealed two valuable veterinary drugs. (Evidence, pp.7818-9)

5.15 Dr Janssens of the Australian National University

expressed the research imperative in the following terms:

We believe that basic research, is an

appropriate and necessary activity for

science. The physiology, biochemistry,

structure and function of animals are

important areas of study in their own right. We can only maintain the physical and

biological world if we understand it; only by knowing the way in which animals function can we understand how changes in the environment will affect them; only by studying animals can we understand our relationships to them . We make no apology for saying that we support the

use of animals in basic research.s (Evidence, A.N.U., p.103>

69

5.16 The Committee noted that ANZFAS did not recommend that

all experiments related to basic research should be banned; only those which caused pain or suffering. This is in line with

ANZFAS' recommendation to ban all experiments which cause pain or suffering. The main argument put by ANZFAS against basic research was the amount of poor quality basic research carried out,

particularly in Australia. The Committee does not condone poor quality research, especially where animals are used in

experiments. However, the existence of poor quality research, if it can be proven to be of poor quality, is not an argument

against the principle of using animals in basic research. It is an argument for tightening controls over the conduct of such

research.

5.17 With regard to the argument that much basic research

leads to no benefit at all does not invalidate the conduct of

such research. Inevitably, the nature of basic research militates against a high success rate in benefits and discoveries,

particularly when compared with the results of applied research.

5.18 The Committee has not recommended the banning of

experiments Consequently, which as the

cause pain

Committee or

does

distress not draw

to animals.

a distinction

between basic and applied research, it does not recommend a ban on one and not the other.

5.19 The important point to address is the need for research

to be well thought out. Where endpoints of research are largely indefinable because of the nature of the research, greater care should be taken to ensure that animal experimentation is

absolutely necessary. Ethics committees, funding bodies and accreditation panels have a responsibility to ensure that

standards of basic research are upheld.

70

Repetition of Experiments

5.20 The scientific method is based on

experimental results of a

data. It is important

project, particularly to be

the replication of able to verify the

one which has significant

ramifications for scientific research. Replication is also a disincentive for deliberate scientific fraud.

5.21 Dr G. Alexander, representing AFWA, explained:

Every time a new worker takes up a piece of

work or a new laboratory takes up a piece of

work they have to establish baselines and

until they can make sure that the baseline or the factors reported in the literature get the same result they cannot advance. If you are

trying to determine dose rates for any

treatment, animal variation is a major problem and you have to repeat things until you have a reasonable mean value . . . 9

5.22 Professor King, who also appeared for AFWA, outlined his understanding of the guidelines for repetition of experiments.

5.23

If you do an experiment you make a statement

at the end of it. If statistics were applied

to the data, you make a statement such as this could have happened by accident, one out 20

times. You do not know whether you have picked up one out of 20 or whether it is a regular 19

out of 20. So for that reason you have to

repeat and the more unreliable your data is, the more you have to repeat it. So there are

guidelines for repetition. If you have a

difference that has one in a million times

chance of happening by accident then,

obviously, you feel you are on a pretty strong thing. If you have something that could have happened by accident one in 20 times then

there is much more room for scepticism in

there.lO

The Committee received much criticism of repetition of experiments on animals. Although some repetition is not all of it is necessary. Unnecessary repetition of is where experiments are repeated, usually by

essential, experiments different

71

experimenters, in the knowledge that no useful purpose will be achieved in conducting them or because the experimenters were not aware of the earlier projects. Not all projects have their

results published or the results are not readily accessible.

5.24 The difficulty is often deciding whether experiments

need to be repeated. This is something that departmental heads in institutions, funding bodies and ethics committees need to

scrutinise carefully before approving projects.

5.25 Sometimes, both critics and experimenters fail to make

explicit the distinction between a research project and the

ensemble of actual experiments that make up the project as a

whole. The funding bodies and ethics committees will view the project as a whole. Numbers of the experiments wit.hin a project may in fact repeat previous work in order to establish a baseline for those experiments within the project which extend the

boundaries of previous work.

5 . 26 Witnesses for the scientific community repeatedly

emphasised that unnecessary repetition of experiments was

unlikely because funds within Australia for biomedical research are limited. There is an intense competition to obtain research grants. The success rate for NHMRC grants for example is about 30 per cent.ll

5.27 Some of the funding for biomedical research has not come

from outside funding bodies but from funds available through university departments. This has meant that the peer review

system has not been applied rigorously to all projects.

5.28 It also needs to be acknowledged that research science

as a whole is a 'social system' in which judgements of value will be made extensively when it comes to funding priorities. It seems unlikely that such decisions will not be influenced by such

factors as the general standing of the person or organisation

72

requesting funds and assumptions as to the significance of the project, such as, whether it fits into current thinking in the

fi e ld in question or whether it is regarded as being socially

de sirable . Even the most rigorous assessments cannot provide any guarantee that 'low priority' and relatively repetitious

experiments will not be funded. Studies of the peer review system and refereeing of articles for journals in a variety of fields of s cience within the U.S.A. have suggested that randomness and r eviewer bias exist even in the most prestigous funding bodies.l2

5 . 29 Repetition of experiments is another area where

departmental heads in institutions, ethics committees and funding bod i es need to be vigilant to prevent abuse occurring. It is not s omething that can be controlled by regulation or other

government control. Unnecessary repetition of experiments i nvolving animals is both unethical and a waste of scarce

resources. It is in no-one's interest to allow unnecessary

r e petition of experiments to occur. Scrutineers of protocols need to be fully satisfied that repetition is essential for the

s uccess of the project and that the experimenter has assiduously searched the scientific literature for similar projects

elsewhere before the protocol is approved.

Alternatives

5 . 30 Alternatives to animal experimentation include those

or methods that replace the use of laboratory animals techniques altogether, reduce the number of animals required or refine the e xisting procedure or technique so as to minimise the amount of pain or distress endured by the animal. Most of the alternatives

to the use of animals in experiments fall into one of the

categories listed below:

73

5.31

the continued but modified use of animals, including

alleviation of pain and distress through analgesics and less

cold-blooded intrusive methods, substitution of

for warm- blooded vertebrates,

co-operation among investigators in the shared use of animals, and the better statistical design of

experiments to obtained with

previously;

enable fewer reliable information to be used animals than were

the greater use of living systems, including

micro-organisms, invertebrates and the in vitro culture of organs ; tissues and cells;

the greater use of non-living

epidemiologic data bases of

causes of death and physical

biological functions; and

including

human diseases and. systems that mimic

(d) the further development of computer programs that simulate biological functions and inter-actions.

A recent extensive report by the U.S. Congress Office of Technology Assessment summarised the advantages and disadvantages of alternatives in biomedical research. The advantages of

alternative methods in biomedical research include the following:

* reduction in the number of animals used; * reduction in animal pain, distress, and

experimental insult; * reduction in investigator-induced,

artifactual physiological phenomena; * savings in time, with the benefit of

obtaining results more quickly; * the ability to perform replicative

protocols on a routine basis; * reduction in the cost of research; * greater flexibility to alter conditions and variables of the experimental protocol;

74

* reduction of error stemming from

interindividual variability; and * the intrinsic potential of in vitro

techniques to study cellular and molecular mechanisms.l3

Many of these alternative methods inherent disadvantages. The relevance

disadvantages will vary substantially from another . Th e disadvantages are:

are accompanied by of any of these

one experiment to

5 .32

* reduced ability to study organismal growth p r ocesses; * reduced ability to study cells, tissues,

and organ systems acting in concert; * reduced ability to study integrated

biochemical and metabolic pathways; * reduced ability to study behaviour; * reduced ability to study the recoverY, of

damaged tissue; * reduced ability to study interaction

between the organism and its environment; * reduced ability to study idiosyncratic or species-specific responses; * reduced ability to distinguish between

male- and female-specific phenomena; and * a handicap to probing the unknown and

phenomena not yet identified.'l4

Some of the points in

illustrated by comments made by

the OTA summary above were Professor Shellan at the

University of Western Australia. Asked about the developments in in-vitro methods and the reduction in the use of animals in

e xperiments Professor Shellan replied:

In the area of immunology, which is my area of interest and expertise, in vitro research has been the predominant mode of research since the mid-1960s and I should think that the

discipline is perhaps pre-eminent in its use of tissue culture systems. There has been,

however, a slight swing back to the use of

whole animals in the last five years or so as

it has become recognised that the in vitro

system does not mirror in any way the complex interactions which one sees in whole animals. One has to regard the operation of the immune

75

system as very much like an electronic circuit with feed-back loops and so forth, if you will pardon the jargon. The immune system in the

whole animal operates like this. In tissue

culture systems one can only study parts of

this but not understand the whole. There is

now a move in immunology and other related

biological sciences, not a predominant move but at least a trend, towards going back into

the whole animal now to put the whole system

back together, if you like, to see how it

works.lS

Tissue Cultures

5.33 The potential of tissue cultures to replace animals in

biomedical research is often mentioned in the debate on

alternatives.

5.34 'Tissue culture' is used as a generic term for a number

of types of preparation in which living tissue is kept in vitro . It has been divided into three forms:

<1> Tissue culture proper. This term describes the placing of very small fragments of living tissue into a suitable nutritive fluid, so as to keep it alive. If the culture is

successful, living cells rapidly migrate from the fragment, leaving the original tissue

disorganised. The method is now rarely used, having been replaced in many applications by cell culture. <2> Oroan culture. This technique also begins with a fragment of tissue, but the fragment is

studied only in the early, organised state, where the cellular elements of the culture are intact, functional and in their normal

relationships with each other. Organ cultures are short-lived compared with other in vitro models. They are difficult to maintain, except in the case of certain embryonic organs, and

their use seems, within the forseeable future, likely to be in specialised, ad hoc

investigations, rather than as generally

applicable alternatives to animals.

76

5. 35

<3> Cell culture. Here the tissue is

deliberately disorganised at the outset by disaggregating the cells. The usual method is simple mechanical disruption or enzymic

disgestion, which destroys the normal

connective structures of tissue leaving a

suspension of living cells in nutritive fluid . These cultures are probably the commonest

models used in vitro for biomedical

experiments.l6

These three forms of tissue culture are often referred t o interchangeably or are not clearly defined in popular

discussion. Each form has a distinctly different potential to replace the use of animals in experiments.

5 .36 In recent years, there has been an increasing trend in

the use of tissue culture in substitution for the use of animals i n experiments. There are, however, inherent limitations in the use of tissue culture in that it cannot replace whole systems

wi th all the interactions among their component parts.

Refinement of Experimental Procedures

5 . 37 Refinement as part of the 'alternatives strategy' has

not received nearly the same amount of attention as replacement o f whole animals and reduction in the numbers used. Yet it offers a n immediate improvement in laboratory animal welfare. Refinement o f techniques includes the following:

the reduction of environmental stress; the reduction of handling stress; and the minimisation of the severity of the endpoints of experiments.

5.38 The reduction of environmental stress can be achieved by the provision of appropriate lighting, humidity and temperature control, air circulation, cage cleaning procedures and housing requirements.

77

5 . 39 To reduce handling stress, proper training of bota '

experimenters and laboratory and animal house staff is required . j Staff training is discussed in Chapter 11 while training o f ,

experimenters is discussed in Chapter 12.

5.40 Minimising the severity of the endpoints of the

experiment includes such things as keeping the amount of tissue damage or the size of tumours to a minimum and euthanasing an

animal instead of allowing death to be the endpoint. The types o f studies amenable to this type of refinement include radiation studies, limiting

certain animal models the survival times

abnormalities.

of disease and of animals

toxicity studies with induced

5 .41 The appropriate use of anaesthesia surgery and

analgesia in post-operative care is another area where

refinements in procedures can improve welfare. Dr P. Flecknell, a British expert, commented:

... relatively little attention has been given to the problem of minimizing the pain and

distress caused to animals by the various

procedures to which they are subjected ... The prevention or alleviation of the pain

associated with such procedures is a complex problem with no single, simple solution.

Consideration must be given to the use of

analgesic drugs, the provision of high

standards of general care, and the use of

special nursing techniques. When dealing with post-operative care, the pre-operative

management of the animal, the operative

procedures and the anaesthetic regime must all be evaluated and, when necessary, modified to minimize pain or discomfort.!?

5.42 Experimenters should seek to induce only the minimum

pathological change necessary to assess the efficency of

therapeutic measures. They should also provide relief for

symptoms that do not interfere with the pathology that is being studied .

78

Funding of Alternatives

5 . 43 It was argued by some experimenters that specific

funding for research into alternatives is not required because experimenters will naturally tend to seek out and develop

alternative methods without such encouragement. Professor Setchell commented:

I believe, as I have already said, that these

things will flow naturally as the science

progresses.18

5.44 However, several experimenters appearing before the

Committee endorsed the concept of funding alternatives. Dr Aitkin of Monash University drew attention to the difficul.ty of finding a source of funds to conduct research into alternatives because often such research does not fall neatly into the scope of

existing research grant programmes.19

5.45 As mentioned in Chapter 2, animal experimentation is

likely to continue until satisfactory alternatives are found. In recent years, experimenters have become more aware of the ethical issues involved in using animals in experiments and of public concern about that use. This has led to a greater use of

alternatives, in one form or another. Little research has been done, however, in Australia to expand the range of alternatives available to experimenters. Funding of such research has always been a low priority, particularly in times of contraction of

government research funds. Yet, if the use of animals in

experiments is to be reduced or abolished, alternatives have to be found. A greater commitment must therefore be made by the

scientific community and government to finding alternatives and to reducing the use of animals in experiments.

79

5.46 There is a case for the establishment of a special fund

to encourage the development of alternative methodologies. Requiring funding bodies to assign quotas to their grants as

recommended by ANZFAS may not be the most effective way of

proceeding.

5.47 The Committee believes that a fund should be established

to finance research into the use of alternatives. It should be

separate from existing funding bodies and ·its funds should be disbursed by a board made up of representatives of the scientific community, animal welfare organisations, ACCART and relevant government authorities. It should be funded mainly by the

Commonwealth Government but the board should solicit donations from the corporate sector and the community at large. A small

secretariat should be funded and located in Commonwealth

Government department.

5.48 By establishing a separate fund for research into

alternatives, more emphasis will be given to such research and to the use of alternatives. It is difficult at present to get

funding for research into alternatives because it is usually a lower priority than biomedical research itself. In the highly competitive biomedical research arena, few experimenters will try to seek grants for research into alternatives because of the

difficulty in receiving funding. With a separate fund set aside for this purpose, experimenters will have a better prospect of having research into alternatives funded.

5.49 The Committee RECOMMENDS that the Commonwealth

Government establish a separate fund for research into the use of alternatives to animal experimentation and that grants be

disbursed from this fund by a board composed of representatives of the scientific community, animal welfare organisations, ACCART and government authorities.

5.50 Alternatives to toxicological testing are discussed in Chapter 7.

80

CHAPTER 6

THE USE OF ANIMALS IN THE PSYCHOLOGICAL

AND BEHAVIOURAL SCIENCES

Introduction

6 . 1 The phrase 'psychological and behavioural sciences' is

used throughout this chapter as a generic term to cover a number of diverse but partially overlapping fields of research. These include ethology, comparative psychology and physiological psychology.

6 . 2 Comparative psychology is that branch of psychology

which deals with the comparison of behaviours of organisms of different species. Physiological psychology explores the

physiological bases of behaviour including the anatomical

structures and physiological processes which are related to psychological events and mental functions. The central nervous system and neurological processes are central areas of concern. Ethology is the study of animal behaviour:

In addition to being a challenging science, worthwhile in itself in the same way in which other explorations of Nature have been,

ethology is also increasingly assuming a

practical role. In almost every case where man takes decisions concerning other animals - in zoos, wildlife refuges, laboratories a

knowledge of animal behaviour can aid his

understanding of the problems. Whether the aim is exploitative , concerned with

welfare (assessing possible adverse effects of intensive indoor husbandry>, 'pest' control

81

disease or by pests on food crops>, or

conservation , the key to success often lies in a proper

understanding of animal behaviour. Many

ethological experiments are undertaken with the aim of solving a particular practical

problem in fields like these ... 1

Ethology is mainly dealt with in Chapter 8.

6. 3 There are, however, difficulties in precisely defining

the boundaries of the behavioural sciences in general and the

discipline of psychology in particular.

6.4 Much of the research in the field of physiological

psychology, for example, is similar to basic biomedical research. The University of Newcastle noted:

The definitive line between these areas is not necessarily obvious because although

psychological research is directed at the

Central Nervous System and the brain, the techniques are often common with other research areas.

Thus in order to identify those projects

involved in 'psychological and behavioural research' we include those studies which

address questions concerning the function of the CNS and brain disorders and which

incorporate any behavioural techniques

including general observation.2

6.5 The scope of experimentation and the extent of its

overlap with other areas of biomedical research is illustrated by the following six subject areas under which research projects in psychological and behavioural research carried out at the

University of Newcastle during 1986-87 were classified:

Behavioural Manipulation of System. The Pharmacology of the Drug

Response. Hormonal and Neurochemical Psychological Stress.

82

the Immune

Withdrawal

Effects of

6 . 6

point:

Biochemical Control of Sleep Patterns. Neural Basis of Visual Perception and

Memory. Cortical Mechanisms Underlying Psychosis.3

Professor Bond from Macquarie University made a similar

I think there is considerable evidence

that many of the disorders that one sees are, in fact, physiologically-based and then often require animal research to tease out problems associated with them. I am thinking of things

such as schizophrenia, manic-depression, the various dementias, Alzheimer's disease and movement disorders such as Parkinson's

disease, disorders associated with substance abuse like Korsakoff's disease and so forth. The use of animal research in psychology in

examining these sorts of problems has been

both to have a look at what happens in normal

situations and what happens in abnormal

situations. In that respect I do not see them

as standing outside, for example, other

biomedical sciences.4

Extent of Psychological and Behavioural Research in Australia

6 . 7 The Australian Psychological Society submitted that most psychological and behavioural research conducted in Australia and overseas does not involve the use of animals. It stated:

6 . 8

The use of infra-human animals in Australian psychology is not extensive. Indeed, research with animals, despite its theoretical impact, probably constitutes considerably less than

10% of published work. At an international

level, 7.4% of papers abstracted in

Psychological Abstracts in 1979 used animals as subjects.S

Experiments range from observation of animals in their natural state to experimental studies of the behaviour of animals which have been reared and maintained in laboratories. Laboratory studies extend from those which are relatively non-invasive

example, studies of maternal behaviour in rats> through to those

83

which place animals in situations of varying levels of stress ; studies of patterns of behaviour influenced experimentally b y food deprivation or aversive stimuli Cfor example, by electric s hockl; and invasive studies which include pharmacological,

surgical and other physical interventions.

6 . 9 As was noted in Chapter 2, comprehensive figures on

animal experimentation in Australia are not available. The

breakdown of figures collected by the Victorian Bureau of Animal Welfare provides, however, some indication of the extent of

animal use in psychological and behavioural experiments within that State. The figures are set out in Tables 6.2 and 6.3 for the

five years from July 1982 to June 1987. Table 6.1 covers only

animals used for research purposes. The category of animals used for teaching purposes does not include a breakdown of the various subject areas in which animals are used.

84

Iut:et:fetare 'Wi.th ant::Ial rEI:\U.E Ird.ct.im of

I:ntecfem re 'Wi.th f¥Cia_l systen etta: tim '1W:! af a:m:s :fi:r b:tavia.n:al. a:m:s :fi:r l::Eh:Mrur:al 1J:E of ctTer tim cy

"'.e:teh ate stu:ii.es stu:ii.es stimili stimili

1982-3 1984-5 1986-7 1983-4 1..985-£ 1982-3 1984-5 1986-7 1.983-4 1985--6

1.963-4 1985-6 1982-3 1984-5 1986-7 1.963-4 1985-6 1.982-3 1984-5 1.986-7

Mule 740 50 4Sl 160 100 J79 72fj 188 1

R:rt: 2,188 1,160 3aS 283 :rn 9(6 853 548 887 15 193 170 212 198 125

Griim Pig 2 1 .36

Cl:h:r R:d:nt 4 3

R:thi.t 7 50 12 15 4 67 4

cat 2

rtg 4 1

Cl:h:r Qnni'\Cm 5

Ilrley

lblim 40 9

Sa:p 11 7 14 5 10 23 2 297 4

DB:: Pig 124 .32

Cl:h:r ttg.llat:e Mrrspial 6 6 12 J) 5

P.!:imlt:e 2 2 1

Cl:h:r Mmral D::rrestic R:wl J)Q 312 13,7.32 10,825 10,o:rJ 8,700 J:>,585

Cl:h:r D::ne;tic R:llltzy Cl:h:r Bi.n:E 10

1 25

'ltJIN.. 2,978 1,:N3 533 347 1,103 14,m 11,946 10,556 9,356 21,885 835 225 526 170 8 213 198 134 10

s::IR.E: ll:{mbrall:. cr. A;)ri.rultuJ:e arl R.D:al. Affail:B . Stntisti.cs cr. krinal. V.ictxria • ..1lrE 1984, Miy 1985, S:I:tart:e:: 1..99), Cl:td:a- 1.987, ra:ad:a:' 1.987. EXtm:::t fn:rn 'ntl1e 8, N.nte:::s ct 1niim1.s um 1:¥ '1W:! ct "'.e:td:::nt:t:e a:rl 'IB::1niqB3 um.

Table 6.2: Animals Used in Psychological and Behavioural Research in Victoria

Annual Total 1982-3 1983-4 1984-5 1985-6 1986-7

18,825 12,704 13' 358 10,007

23,006

Table 6.3: Experiments to Study Behaviour in Animals

Types of Vertebrate 1982-3 1983-4 1984-5 1985-6 1986-7

Mouse 951 2,513 200 150

Rat 1,304 796 314 1,001 922

Guinea Pig 76 '2 25

Other Rodent 18

Rabbit 11 4

Cat 7

Dog Other Carnivore 4 5 4 26

Horse, Donkey Bovine 67

Sheep 19 324 119 411

Goat 80 210

Deer Pig 12 24 50 33 490

Other Ungulate Marsupial 34 50 105 53 71

Primate Other Mammal 84 24 12

Domestic Fowl 1,185 550 366

Other Domestic Poultry Other Bird 1 7 30

Amphibian

TOTAL 3,574 3,981 886 1,539 2,764

SOURCE: Department of Agriculture and Rural Affairs. Statistics of Animal Experimentation, Victoria. June 1984, May 1985, September 1986, October 1987, December 1987. Extract from Table 2 Numbers of animals used by type of vertebrate and major purpose of animal use.

86

6.10 The Committee received information through the AVCC from 15 Australian universities on the extent to which animals were

used in research and teaching in the psychological and

behavioural sciences. The numbers of animals used in those

universities in 1986 and 1987 are tabulated in Table 6.4. Three out of the 15 universities were not involved in animal use for

research and teaching in this field. Only four of the 15

universities used animals for teaching purposes in the

psychological and behavioural sciences.

6.11 The increase in the number of animals used in 1987 was

largely due to the increased use of chickens at La Trobe

University. The experiments involving chickens were explained by Dr Coleman of La Trobe University:

There is a research team in our department

which is basically looking at the physiology of memory. What it has been doing is to

develop a model of the phases through which

the acquisition of information goes from

short-term memory when it decays very quickly to permanent memory. Basically what the team is trying to do is to tease out what the

physiological mechanisms of these are - which proteins are involved and so on. Each chick is only ever used once. It pecks once at

something and that is it. That is why the

numbers of units are so large.6

87

Table 6.4: Statistics of Animals Used in Teaching and Research in the Behavioural Sciences in Australian Universities 1986 1987

Rats 8,940 8,486

Mice 1,816 3,262

Fish 50 192

Chickens 13,626 31,252

Birds 40 88

Australian Native Mammals 503 558

Cats 10 2

Rabbits 100 100

Guinea Pigs 220 171

Primates 10 10

Fish 5 5

Cattle 600 600

Sheep 600 600

Goats 600 600

TOTAL 27,120 45,926

SOURCE: AVCC (Universities for which statistics were not available were: University of Melbourne, University of Queensland, University of Western Australia, Murdoch University>.

6.12 The Australian Association for Humane Research submitted to the Committee in May 1984 a survey of psychological and

behavioural research conducted within Australia between 1966 and 1983. The survey was based upon a search of the Psycinfo computer data base which provides a coverage of the literature in

psychology and the behavioural sciences. The experiments reported in the literature survey are classified by:

6. 7.

(a) species of animals used; type of experiments; and

(c) institution at which the study was conducted.

The information is reproduced in Tables 6.5, 6.6 and

88

Table 6.5: Australian Behavioural Research Literature Survey 1966-1983 - Species of Animals and Numbers of Experiments

SQecies of Number of SQecies of Number of

Animals Used ExQeriments Animals Used ExQeriments

Rats 92 Mice 2

Pigs 2 Pigeons 1

Parrots 1 Octupii 1

Cattle 1 Spiny Anteater 1

Chickens 15 Fish 1

Dogs 2 Shrimp

Cats 4 Un-named 1

Table 6.6: Australian Behavioural Research Literature Survey 1966-1983 - Types of Experiments

TY!2es of ExQeriments

Avoidance Conditioning Operant Conditioning Aversive Conditioning Escape Conditioning

Other

TOTAL

89

83 5

14 5

18

125

Table 6.7: Australian Behavioural Research Literature Survey 1966-1983 - Number of Experiments Performed at Various Institutions

Macquarie University University of N.S.W. Sydney University Newcastle University Queensland University Australian National University La Trobe University Western Australia University

University of New England Monash University Melbourne University Adelaide University

Flinders University Otago University (N.Z.) Animal Research Institute (Werribee, Vic.> N.S.W. College of Paramedical Studies Royal Childrens Hospital (Parkville, Vic.)

Secondary Teachers College (Melbourne, Vic.) Lincoln Institute (Carlton, Vic.) Psychiatric Research Unit (Rozelle, N.S.W.> Austin Hospital Health Commission of N.S.W. Australian Military Forces Research Report

Department of Agriculture

Numbe r !

31 8

5

15 1

1

20 8

4

5

1

6

1

1

2

2

1

1

2

2

1

1

1

1

1

2

1

The Use of Animals in Psychological and Behavioural Research

"6.13

research previous benefits

Proponents of the use of animals in this area of

presented similar arguments to those advanced in the chapter on biomedical research. They emphasised the to both humans and other animals based on results

derived from psychological and behavioural experiments.

90

6.14 The Australian Psychological Association submitted that animal research has provided the basis for the development of

therapeutic techniques for the treatment of a wide range of

psychopathologies. Teaching practices have also benefited from such experiments.

In addition to therapeutic practice and models of psychopathology, principles of learning derived from animal research have profoundly influenced teaching practices. The influences

include the use of positive reinforcement

(reward> instead of punishment as the basis of effective teaching and classroom management and systems of programmed learning. More

recently in Australia, animal research on

classical conditioning has prompted a

re-examination of certain problems that arise in teaching children to read, name17, the

interference between pictures and words. .

6 . 15 Such experiments were viewed by the Society as being

technically necessary or at least highly desirable if certain types of information were to be obtained. Developmental studies, in which age as a function of behaviour is examined, are an

example of this category of experiment. This is because there are difficulties in doing developmental studies on expensive; samples of different age groups have humans. They are

to be used; and

there are various cultural factors which add to the variables

which may distort the results. Because of the short life span of animals, longitudinal studies over the life of animals can be

done, reducing the risk of variables, the results. Experiments on animals

environment which removes cultural individual animals.8

other than age, affecting can also be done in an

differences from among

6.16 Another argument supporting the use of animals in

behavioural research by the Australian Psychological Society was that:

91

6.17

Many hypotheses about human behaviour are

derived from research with animals that could not be performed with humans. For example,

animal research has frequently been able to model a variety of psychological problems

(e.g., psychopathology, addiction> which occur in humans. Research of this kind provides

fundamental knowledge about the processes that are involved in a variety of disorders.9

The Australian Psychological Society also outlined in its submission the benefits for animals derived from experiments on animals, such as the non-lethal control of animals that are

harmful to crops, improvements in the care of farm animals and

'the design of optimal captive environments for the protection and breeding of endangered species' .10

6.18 The Society submitted that human benefits from

psychological experiments on animals ranged from the application of behaviour therapy and behaviour modification to treat various disorders including enuresis, phobias, anxiety, anorexia nervosa amd stuttering. These techniques are also used in connection with sexual dysfunctions, disorders of conduct and self care in

psychiatric institutions.ll

6.19 Many types of psychological and behavioural experiments mentioned above by the APS are not and have not been conducted in Australia. They were put forward as a general case supporting the use of animals in psychological and behavioural research.

6.20 Some pyschologists deny that experiments involving

animal behaviour are at all relevant to human psychology.12

ANZFAS submitted that it:

questions the principle underlying the reasons for using animals in psychology

research, that is, that interference and

modification of animal behaviour patterns constitute a suitable model for the study and treatment of human behavioural problems.

92

Finally, it may be noted that the humanistic school of psychology, which involves

counselling of individuals, does not make use of the results of animal experimentation and opposes the theory of the behaviourist school. Techniques of the humanistic school are

appropriate to many neuroses, addiction and anxieties, etc.13

6.21 The use of animals in psychological and behavioural

research has been questioned, not only on the grounds of the

humane treatment of the animals, but also in what Andrew Rowan refers to as 'the psychologist's paradox'.

6.22

Since we should, if consistent, confer moral worth according to some property (or

properties> of the organism's nervous system, then the more suitable the animal is as a

model of the human psyche, the greater should be the attention to the ethical issues

relating to the research. The paradox boils down to this - the better the animal is as a

model of the human psyche, the more restricted its use should be. As a result of this

paradox, psychologists using animal models to gain insight into human psychology must show:

1> that the animal is being studied in a

manner that does not raise moral issues, using human criteria as a guide but not necessarily as absolute standards; or 2> that the animal is sufficiently different

from human beings in its psychological and

mental makeup to create no moral problems and that it is still a relevant model for learning about a particular question in human

psychology; or 3> that the

similarities this does not

This

animal's psyche has relevant to the human psyche, but that

create a moral problem.14

Addressing this assumed that the

view was not accepted by some scientists.

'paradox', Dr Bond told the Committee that he

ethical standards remained the same for all

animals and that standards did not vary according to the

similarities between various animals and humans. He also did not believe that experiments on particular animals were conducted

93

just because of similarities between those species and humans . Sometimes a species is chosen because of the differences between it and humans in order to get a broader view of the subject. He

added, however, that if a species were 'a totally unreasonable model, then of course it should not be employed' .15

6.23 The manner in which animals are used in psychological

research has been strongly criticised. The issue of pain and

stress was raised in the ANZFAS submission and a number of

examples of experiments conducted within Australian institutions in recent years were cited. These included use of electric shocks to study aversive behaviourl6; administration of substances subjected to abuse by humansl7; and aggression research.l8

6 . 24 The actual extent of pain caused in the procedures

involving the use of electric shocks was queried by experimenters representing the Australian Psychological Society.l9 They pointed out that the effect on the animal depended not just on the

intensity but also on duration and other factors. They argued that in aversive experiments in Australia, low intensity shocks have been used.

6.25 As mentioned earlier, there are various forms of

psychological and behavioural experiments, ranging from

observational to invasive or aversive conditioning experiments. Some of these experiments overlap with biomedical, agricultural or veterinary research. The levels of pain or distress caused to animals by these experiments range from insignificant to severe.

It is not possible, therefore, to categorise psychological or behavioural experiments as an homogeneous whole. Similarly, the recommendation by ANZFAS that psychological experiments be banned by legislation is inappropriate.

94

6.26 From the evidence available, it appears that there is a

greater awareness by scientists that some types of experiments are either unacceptable to the public or are no longer regarded as necessary from a scientific point of view. It also seems that

greater use is also being made of alternatives in the teaching of psychology.

6.27 The Committee concludes that although it does not

believe that a ban on psychological or behavioural experiments is justified, each protocol involving such experiments should be considered carefully by the relevant ethics committee and funding body to determine whether the project is necessary and whether it

conforms to the Code of Practice. Although it is inappropriate to use humans in some psychological and behavioural experiments, consideration should always be given to their use. Liaison

between animal and human ethics committees in such cases would be desirable.

95

CHAPTER 7

ANIMALS IN TOXICOLOGICAL TESTING

Introduction

7.1 An assessment of the use of animals in testing drugs and

cosmetics requires some understanding of the nature of

toxicological research and the regulatory framework within which it currently operates. A brief account of the scientific basis of toxicological testing is given before issues are

considered.

7.2 There are two basic approaches to the science of

toxicology - the mechanistic and the descriptive. Mechanistic toxicology is the study of the chemical processes by which a

toxic effect occurs. It relies on techniques developed by

physiologists, biochemists and analytical chemists to monitor these processes. Mechanistic toxicology is research oriented. It provides the basis for the design and interpretation of

descriptive tests and is essential to the development of testing methods that could replace whole-animal testing.

7.3 Descriptive toxicology relies on the information

provided by pathology, statistical analysis, physiology and pharmacology. It involves, for example, evaluation of changes in the appearance of an organ or its cells, the appearance of

tumours or signs of irritation. An understanding of the exact

nature of the processes by which the toxic effects occur is not necessarily required. Regulation of chemicals requiring testing for toxicity relies largely on descriptive toxicology.l

97

7.4 Many toxicological tests currently require the use o f

whole animals. The most appropriate animals are those which

predict the human response to a specific substance most

accurately. The choice of animal is influenced not only by the similarity of the animal's organism or biochemical mechanism of concern to the testing authority to that of humans, but also of

such factors as the convenience of breeding, the extent of

pre-existing knowledge of the species, species lifespan, ease of handling of species under experimental conditions, cost of

purchase and maintenance, litter size and gestation period.

Testing Strategies

7.5 In most toxicity tests the substance tested is

administered by the same route as occurs in the course of

accidental exposure or

palatability, solubility, use by humans.

stability, and

On occasions the

volatility of a

substance determines the routes that are feasible.

7. 6 The dose levels employed in a testing programme need

careful consideration. If the dose is so large that many animals die before the end of the test, it will not be possible to detect

long-term effects. If the dose is representative of human

exposure levels it may not produce detectable effects without the use of an excessively large number of animals over a long period of time.

7.7 The test design must be statistically sound if valid

results are to be obtained. Factors influencing the number of animals needed for a given test include:

Cl> the need to allow for unexpected death and illness

in the test group; C2> variability in the sensitivity of individual

animals to the substance being tested; and

98

(3) the need for an untreated control group to provide information on the background incidence of disease against which the incidence in the groups

discussion in being tested can be assessed.2

Drug and Chemical Testing in Australia - Regulatory Requirements

7.8 The Commonwealth has no direct constitutional power to

regulate drugs and chemicals. It does have, however, some

indirect means of control by virtue of its constitutional power over imports. This power is exercised through the Customs

ingredients. However, the Commonwealth cannot prohibit drugs which are manufactured from ingredients sourced within a State and sold within the same State. State legislation covers the

extent and nature of testing required before marketing of

therapeutic goods and agricultural or industrial chemicals.

7.9 Through

Governments, there the is

co-operation of Commonwealth and national co-ordination of the State safety

assessment and control of chemicals. A plethora of expert

committees comprising Commonwealth and State officers and experts from the industry and universities carry out the assessments and provide advice to government on the control and regulation of chemicals.

7.10 Drugs for human therapeutic use are evaluated by the

Australian Drug Evaluation Committee supported by the Drug Evaluation Branch of the Department of Community Services and Health.

7.11 The NHMRC is responsible for the toxicological

assessment of most chemicals not designed for therapeutic use, including agricultural chemicals. With regard to agricultural and veterinary chemicals, national co-ordination has been in the

99

hands of the Co-ordinating Committee on Agricultural Chemicals which has been responsible to the Australian Agricultural

Council . The enactment of the Agricultural and Veterinary

Che micals Act 1988 represents an attempt to provide a more

co-ordinated approach to the regulation of agricultural and veterinary chemicals. Under the Act an Australian Agricultural and Veterinary Chemicals Council will be established to

co-ordinate the evaluation of chemicals proposed for registration in Australia, including assessments of toxicology, human safety, environmental hazard and overall efficacy.

7.12 Plans to regulate industrial chemicals are intended to

complement current national arrangements for the evaluation of agricultural chemicals, pharmaceuticals and food additives that are already in place.

7.13 The scheme will be established under Commonwealth

legislation although State Governments may decide to enact

complementary legislation. In essence, importers will have to notify NOHSC of imports of industrial chemicals and to provide it with enough information for NOHSC to assess the potential health and environmental hazard of the chemicals. The NOHSC will

generally rely on data used to satisfy regulatory requirements overseas but will if necessary seek additional information. It is expected that most additional tests will be done overseas.

Cosmetics

7.14 The responsibility for national standards for cosmetics ingredients was transferred in 1987 from the NHMRC Consumer Products Safety Committee to the new Bureau of Consumer Affairs within the Attorney-General's Department . In 1986 the Consumer Products Safety Committee of NHMRC had set up a Working Party to prepare appropriate standards

for cosmetics ingredients. According to the Department of

Community Services and Health:

100

7 . 15

The Working Party used the general structure of the EEC cosmetics Directive as a working

document, but amended the lists of acceptable colours, sunscreens and so on to suit

Australian circumstances. Like the European standard, it was proposed that the NH & MRC

Standard would not list all possible cosmetic ingredients. Ingredients were to be included in the various Annexes to the Standard on the basis of either a history of safe use or as a

result of a toxicological assessment.3

The Committee was told by the Department that in

preliminary work prior to the transfer of responsibility to the Bureau, it was established that many chemicals were being used without toxicological work having been done on them. The

Department said that the industry had pointed out that these

chemicals had been used without ill effects to consumers.

Although the Department did not intend to seek ·toxicological i n formation on chemicals currently in use, it would have insisted on the submission of toxicological data on new chemicals.4

General Issues in Testing

7.16 In discussing its approach to testing requirements, the

Department of Community Services and Health made the following points:

1. Animal studies are not required unless they will contribute worthwhile information on the new medicine;

2. Large numbers of animals in any one test

are not required providing that the number

used will be capable of discerning the problem to be investigated;

3. The LDSO test as such is not required,

being replaced with acute studies to include relevant observations; 4 . Non-human primates were required in some studies but this requirement, as such, has now

been deleted;

101

7.17

5. The use of in vitro screening tests is

recognized and accepted;

6 . The Australian guidelines are very similar to and consistent with many overseas

requirements so that any additional animal testing for some medicines is kept to a

minimum;

7. Some overseas countries have required a

certain amount of animal testing to be

repeated in their own country. The Australian Department of Health accepts data generated overseas without any requirement for animal studies to be repeated in Australia.S

Although Australian guidelines are similar to overseas guidelines, there are differences between them. The Australian guidelines are being rewritten to achieve a greater harmonisation of requirements with overseas countries and international

organisations such as the European Community, the Organization for Economic Co-operation and Development and the World Health Organization.

7.18 It should be noted that the demand for further testing

caused by a lack of uniformity in requirements does not mean that such tests would be carried out in Australia. A lack of

uniformity would be most likely to result in an increased use of animals for toxicological testing overseas.

Toxicological Testing in Australia

7.19 Toxicological tests using live animals

done on a large scale in Australia. Most tests are

are not

conducted

overseas where the products are developed. Data from these tests are submitted to Australian authorities in support of

applications for registration of products. The former Australian Bureau of Animal Health outlined the main purposes for which

testing was conducted in Australia:

102

7 . 20

Some chemical evaluation studies are performed in Australia using animals. The purpose of

additional testing is to generate data on the performance of the chemical under Australian conditions, e.g. efficacy against local pest species of weeds, insects or internal and

external parasites. Local testing is also

performed on veterinary drugs to show that the product is safe for the target animal. These tests usually take the form of a medium scale field [trial] where animals are treated with

the drug at an elevated dose rate to assess

the safety in situations of accidental

overdose. Rarely, however, do such tests

involve the estimation of the LDSO in the

target animal.6

In its submission the Cosmetic Toiletry and Fragrance Association of Australia stated:

In this country, the cosmetic indus'try

consists largely of subsidiaries of overseas companies and as a consequence, most research resulting in toxicological validation is

carried out abroad, with an insignificant

level of safety testing locally, carried out by independent toxicological laboratories.

Australian manufacturers of cosmetics have access to all relevant hard copy and

computerised data banks through the CTFAA or from their principals abroad, thus enabling them to eliminate almost all animal testing for cosmetics in this country.?

7.21 There was, however, a distinct reluctance or possible

inability of the relevant industry associations to supply the Committee with statistics from their members on the actual extent of use of animals for toxicological testing within Australia.

7.22 The Department of Community Services and Health provided indirect evidence on the extent of animal use for toxicological testing within Australia. Dr Imray of the Department stated:

There has been no data submitted that I have

seen in the time that I have been with the

Department that has ever been generated

anywhere other than in the major toxicology

103

contract laboratories overseas company laboratories overseas. In submissions that I have seen, I

seen data generated in Australia.8

or through

all of the

have never

7.23 Although the Committee accepts that commercial toxicity testing using animals for regulatory purposes conducted within I Australia is minimal in extent, it is of the view that a

willingness by commercial enterprises to be more open with the public would do much to assuage public concern.

National Biological Standards Laboratory

7.24 The numbers of animals used in the National Biological

Standards Laboratory (NBSL> is contained in Table 7.1. Its use of animals was explained as follows:

3 .1 NBSL testing of products is intended to

assess their quality, safety and efficacy. Quality is a wide ranging concept covering

aspects of conformity with specifications, fitness for intended use and consistency of production ...

3.2 NBSL testing of products for quality is, wherever possible, performed using chemical or physical methods. These methods generally offer advantages of speed, precision and

economy over biological methods. However they are usually only generally applicable to

products whose chemical or physical

characteristics are known. Many biological products such as vaccines, hormones, enzymes and blood products are heterogeneous mixtures of complex compounds whose chemical and

physical characteristics have not been

established. It is usually necessary to

perform at least some biological tests on

these types of products when assessing their quality. 3.3 Biological methods can range from in vitro methods such as biochemical techniques,

immunological techniques, cell culture

techniques and isolated cell or organ culture

104

Period

1975 1976 1977 1978 1979 1980 1981

1982 1983 1983-84 1984-85

1985-86 1986-87 1987-88 1988-89

Prorata

techniques through to in vivo techniques

involving embryonated eggs or whole animals. Where in vitro methods cannot adequately

assess a characteristic of a product a whole

animal technique must be used.

3.4 Safety tests in particular often require the use of whole animals. Safety from the

NBSL viewpoint usually refers to lack of

adventitious contamination with toxic

substances rather than to the inherent

toxicity of the product.9

Table 7.1: The Numbers of Small Animals Issued to Users from NBSL 1975-1989

Guinea

Mice Rats Pigs Rabbits

77,610 1600 1490 * 62,230 900 1370 * 49,200 980 2030 * 87,760 1030 3520 * 75,640 890 2960 * 96,470 830 4510 * 63,060 230 3440 410 52,950 520 3260 405 51,650 290 2300 400 44,420 600 2630 370 35,900 1450 2130 280 32,000 530 2190 225 27,400 370 1590 300 18,000 1560 1410 370 24,000 2280 1704 370 * No records available SOURCE: Evidence, p.S8045 Chickens

*

*

*

*

850 1254 1032 1573 1269 1138 1026

614 1020 925 656

7.25 Detailed statistics on the use of animals in

toxicological tests, including those conducted in course of

research as well as those done to satisfy regulatory

r equirements, are currently only available for Victoria.

105

7.26 Because Commonwealth departments or statutory

authorities involved in animal experimentation are not registered or licensed under the relevant Victorian legislation such

statistics would not include, for example, those animals used by the Commonwealth Serum Laboratories or the CSIRO Division of Animal Health. The Victorian Government publishes annually the number of animals used in the State for toxicological and related

pharmacological research and testing. Figures from that

statistical report for the five years 1982-83 to 1986-87 are

shown in Table 7.2.

7.27 Table 13 in of the Victorian report contains a breakdown

of the figures reproduced in Table 7.2 by types of tests

including a category for tests performed to meet the NHMRC

Toxicological Data Requirement. Because of in

reconciling the figures in these two tables for most categories in most years it was not possible to use the disaggregated

figures with any high degree of confidence. Hence they have not been used in this report.

106

Table 7.2: Number of Animals Used in Toxicological and Pharmacological Testing in Victoria 1982-1987

198 2-83 1983-84 1984-85 19 85-86 198 6-87

Toxicity Tests

2,927 6,097 832 3,885

7,787

Teratological Tests

100 643 124 3

312

Distribution Total

Metabolism excretion and residue tests of substances

22,704 25,731

11,983 18,723

3,676 4,632

5,692 9,580

3,985 12,084

SOURCE: Department of Agriculture and Rural Affairs, Bureau of Animal Welfare. Statistics of Animal Experimentation in Table 4; 1982-83, 1983-84, 1984-85, 1985-86 and 1986-87 reports.

The Role of Animals in Toxicological Testing - Rationale and

Al ternatives

7 . 28 Consideration of animal use in toxicological testing

br ings into focus a major conflict in public expectations. On the on e hand the public wants to minimise the risks to humans,

animals and the environment arising from the development and widespread use of chemicals. On the other hand there are

undoubtedly public reservations about or opposition to the use of animals for toxicological testing.

7 . 29 testing The rationale for the use of animals in toxicological arises from the responsibility of the appropriate

a uthorities at least to ascertain the risks associated with the

107

use of chemicals by the public. This prima facie responsibility is regarded by government as overriding, but not negating moral responsibility for the welfare of animals.

7.30 It appears that whole animal tests are unlikely to be

completely replaced by non-animal or in vitro methodslO because in vitro tests cannot reproduce the functional and structural complexity of the intact animal. In vitro tests cannot preserve the diversity of mechanisms for toxicity and detoxification that exist in living organisms. At each successive level of biological organisation properties appear which are not evident or even present at less complicated levels of organisms or systems.

7.31 Three issues about testing whole animals were raised by

ANZFAS in its submission.

7.32 The first is the difficulty of extrapolating results

from non-human species to humans.ll

7.33 ANZFAS drew attention to the following cautionary note in the OECD Guidelines for Testing of Chemicals:

There is no experimental laboratory species which is identical to man in terms of

structure or metabolism. There are obvious resemblances and similarities in function between man and other animal species, but even in the case of man's fellow primates, these

are not such that straightforward

extrapolations from animal tests to man

are possible. The interpretation of animal test results in the assessment of possible

human health hazard remains a matter of

skilled judgement.12 ANZFAS went on to say:

While authorities require the use of at least two mammalian species for the testing of one substance, the problem of extrapolation is

108

increased two-fold. Not only are there

differences between two species, but also

between animals of the same species within one laboratory.13

It then referred to the work of Zbinden and Flury-Roversi:

7.34

It can vary markedly from one

animal species to the other, and within one

species of laboratory animals the numerical value of the LDSO determined experimentally is influenced by a large number of factors.14

Mr Van Rijswijk of the Australian Veterinary Chemicals

Association responded to the criticism:

7.35

Whenever we use a test animal to work out the

effect of a chemical or a drug we rely on that

test animal to parallel somehow what happens in our bodies. Because the biology is

different - we are not rabbits or rats - that

model is only a model, it is not a perfect

duplication of the human system ..• we can

test thousands of animals and we can test many different species of animals but we are never going to duplicate what that chemical does

inside our body. That is recognised by

toxicologists. If that is the case, adding

more and more animals to that list of testing is not going to give us much more information that really duplicates what is happening

inside us.lS

The scientific literature suggests that while the

extrapolation of the fact of toxicity to humans on the basis of animal studies is a reasonable working assumption, caution is needed in extrapolating the form of toxic action based on those studies.

7.36 In a symposium held in November 1982, Ralph Heywood

conunented:

Surprisingly, there has been little effort to examine the qualitative predictability of human side-effects from animal studies.

109

7 . 37

Occasionally, general papers have suggested that predictions are unreliable In the absence of better data, it must be

concluded from these limited studies

attempting to extrapolate data between

laboratory animal species, and between

laboratory animals and man, that there is no reliable method of predicting what type of

toxicity will develop in different species in response to the same compound.16

ANZFAS emphasised the extent to which the logistics o f

testi ng influence the choice of species to be used in the tests. It drew attention to the OECD Guidelines for Testing of Chemical s which pointed out that such factors 'as ease of breeding or

purchasi ng , animal husbandry, speed of growth/development and handli ng under the experimental conditions' are considerations in choosing the species. ANZFAS went on to state:

7 . 38

For acute oral, dermal inhalation studies the rat is the most frequently used species. The extensive use of rodents in toxicological

studies would appear to be perhaps nearly as much a function of the logistic requirements referred to above as any particular

superiority in predicting the likely human response . 17

ANZFAS also raised concerns about the extent to whic h

data from different testing laboratories were comparable.18 As an example of the deficiencies in this area it cited the example of the difficulties encountered by the FRAME Cytotoxicology Research Project which was completed in 1985. The Project was involved i n the development of non-animal alternatives for cytotoxicology tests. In order to carry out validation studies of the non-animal tests, toxicity data on 100 chemicals was sought, against which the in vitro methods could be measured.

The toxicology data are often not strictly

comparable, being developed in different

laboratories using different species or

different protocols. The reports describing the toxicology data are often inadequate and

110

the data itself may present inherent problems of interpretation, which would result in

legitimate differences in assessments of their toxic effects by different toxicologists.l9

Alternatives

7 . 39 In Chapter 5 the discussion on alternatives to the use

of animals in experiments included those techniques or methods that replace the use of laboratory animals, reduce the number of animals required or refine the existing procedure or technique so as to minimise the amount of pain or distress endured by the

animal.

7 . 40

testing The major

to date have developments in alternatives in come from the reduction of the toxicity

number of

a n imals required for each test and the refinement' of the test

procedures to reduce animal suffering.

7 . 41 Most of the alternatives to the use of animals in

testing fall into one of the following four categories:

(a) the continued but modified use of animals; (b) the greater use of living systems; (C) the greater use of non-living systems; and (d) the further development of computer simulation .

7. 42 The continued but modified use of animals include s

a lleviation of pain and distress through analgesics and less

intrusive methods, s ubstitution of cold-blooded for warm-blooded vertebrates, co-operation among experimenters in the shared use

o f a nimals, and a statistical design of experiments which enables

r e l iable information to be obtained with fewer animals than were

used previously. This can be achieved by reducing the number of

animals used as controls, by using the same g r oup as controls f o r

s evera l simultaneous

by storing data,

procedures, refining

experiments , avoiding duplication of testing reducing pain and distress by changing

the end point of a study.

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7.43 The

micro-organisms, greater use

invertebrates of

and living systems includes

the in vitro culture of

organs, tissues and cells. The advantages and disadvantages of this approach have been summarised by the OTA:

Although animals are still required as a

source for these in vitro systems, the animal would experience distress for a much shorter time, and perhaps less distress overall, than occurs with whole-animal testing because it would be killed before any experimental

manipulations were carried out. Occasionally, different cells, tissues, or organs from the same animals can be used for different

investigations. In addition, many fewer

animals would be required for a given test, in part because variability in the toxic response is smaller than it is with whole-animal and in part because one animal can be used for multiple data points, further reducing

variability. The fact that human tissues

sometimes can be used confers an additional advantage because the need for extrapolation from animal data is obviated.

These isolated components also have

disadvantages. They are usually unable to

prDduce the complete physiologic responses of a whole organism. The components often become undifferentiated and lose their ability to perform their special functions when isolated

from the organism, particularly when the

sample is broken up into its constituent

cells, and even more so when the cells

replicate. Another disadvantage is that the effect of the route of exposure, a variable

that can have profound effects on test

results, is often impossible to determine.20

7.44 Micro organisms such as bacteria and fungi are

principally used to measure genotoxic effects. They can be

cultivated more easily and quickly than most animal or human cells. Their genetic makeup is simple and changes in it are

relatively easy to detect.

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7. 45 Invertebrates such as insects offer the greatest variety of models. The fruitfly Drosophila Melanogaster is best

understood and has been used for detecting teratogenicity,

mutagenicity and reproductive toxicity. The sea urchin has also been widely used for screening for mutagenicity, teratogenicity and reproductive toxicity.

7.46 The greater use of non-living systems includes

epidemiologic data bases of human diseases and causes of death and physical systems that mimic biological functions. However, these cannot be relied on for prospective toxicity testing of drugs or chemicals.

7.47 Whole animals have been replaced with analytical

chemistry for tests involving detection of a substance or

measurement of potency or concentration, such as vaccines,

anti-cancer drugs and vitamins.

7.48 t hat

There is the further development of simulate biological functions and

computer programs inter actions.

Sophisticated mathematical models have been developed which predict biological responses to the drug and hence toxicity on the basis of physical and chemical properties, structure and

available toxicological data. The major limitation of these models is the lack of understanding of the mechanisms by which toxic effects occur.

7.49 In considering the impact of alternative tests the

Department of Community Services and Health commented:

the general consensus of scientific

opinion at present appears to be that, on the basis of current knowledge, no single in vitro (or for that matter, alternative> test will

directly replace any one in vivo test. A

combination or battery of in vitro tests will probably be required for most if not all

toxicological parameters. As a result of

113

putting a chemical through such a battery of tests, it may still be necessary in some

cases, depending on the results, to test it on whole live animals to obtain final

confirmation of the nature of potential

toxicity. One example of particular concern because of its importance is carcinogenesis, which is a complex process, unlikely to be

shown up in a single in vitro assay. Thus it

is likely that a selected battery of

short-term assays, including both in vivo

tests, and in vitro tests in bacterial and

mammalian cells, will be needed to screen

chemicals for their potential to cause genetic effects and carcinogenicity.21

Development of Alternatives in Australia

7.50 Probably because of the small amount of toxicity testing

actually undertaken in Australia little work has been done to develop non-animal toxicological tests by Australian scientists. Most of the developments have been within NBSL and are listed in its submission to the Committee.22

Specific Toxicological Tests

The Draize Test

7.51 The Draize test is designed to test the irritation to

eyes of chemical compounds. It has been criticised on the

following grounds:

it can only provide a pass/fail answer and lacks

fine discrimination, i.e. it does not provide

useful data on degrees of irritancy; because of differences between human and rabbit

eyes its applicability must be in doubt ; and

114

7.52

(c) there are questions about the comparability of

results in routine

laboratories.23

testing from different

As far as the Committee can determine, the Draize test

has been little used in Australia. Among the institutions

surveyed by the Committee only the Department of Pharmacology within the University of Melbourne had conducted Draize tests in the period since January 1980. Over the period 1980-1984, 216 Draize tests had been conducted within the Department. Each

involved three rabbits and according to the University, were done using the most recent modifications to the test.24

7.53 Following a strong campaign by animal welfare

organisations in the United States, funding was by firms

in the cosmetic industry to develop in vitro alternatives to the test. Rowan noted that the response to the availability of

funding demonstrated:

that the availability of funding is a

potent stimulus to thought. When scientists learned of a possibility of research support to develop an alternative to the Draize test a number of speculative and creative proposals were produced and circulated.25

7 . 54 According to the OTA Report, the current scientific view is that no single alternative is likely to be adequate but that a battery of in vitro tests may be a useful replacement.26

7 . 55 In vitro methods to test for irritation are under

development. One promising bioassay for tissue irritation makes use of the chorioallantoic membrane of the chick embryo. Another alternative invoives testing whole eyes in vitro. This method has particular appeal when cow eyes are used because of their ready availability from abattoirs.

115

7.56 The OTA Report, in summarizing the current state o f

research into alternatives to this test, said:

Several types of cell cultures have been used in developing an in vitro test for eye

irritation. The cells used are rabbit and

human corneal cells, mouse and hamster

fibroblasts, human hepatoma cells, and mouse macrophages.

Rapid progress is being made

development of techniques, but none considered validated at this time.

in the

can be

To date, little work has been done on in vitro

replacements for skin irritancy testing.

However, the growth of skin in ·tissue culture is of interest for treating burn victims, and it is expected that culture techniques

currently being developed for that purpose can be used in testing methods . In addition, . it

has also been suggested that suitable

specimens can be obtained from cadavers and surgery and from judicious use of human

volunteers.27

7 . 57 Draize tests using small dose volume and direct corneal

application are being validated currently by Proctor and Gamble. They are of the view that this modified form of test is more

accurate in predicting human experience and less stressful to animals.28

7.58 Although the Draize test remains in use, a reduction in

animal suffering and the numbers of animals used could be

achieved by:

(a) not testing substances with physical properties known to produce severe irritation. (b) screening out irritants using in vitro or less

stressful tests . (c) using smaller volumes of the test substance to

reduce trauma and enable dose response studies to determine safety margins; and

116

7.59 because

the use of local anaesthetics where it is necessary

to test substances that cause pain and irritation in the rabbit.

Some scientists have rejected the use of anaesthetics they deprive the animal of its natural defence

mechanisms, such as blinking.

7.60 The Committee regards the efforts to develop

alternatives to the Draize test as an encouraging example of what can be achieved by co-operation among

organisations, scientists and industry when

targeted funding is provided.

LDSO Test

animal welfare appropriately

7.61 The LDSO test is a general measure of toxicity which

determines the dose which will kill 50 per cent of the target

group of animals.

7.62 The LDSO test has been the subject of widespread

criticism by animal welfare organisations. Its usefulness has also been called into question by toxicologists.29 The figure derived from the test procedure is variable and can be affected by the species, as well as the strain of species used, diet,

microbiological status of the animals, the ambient temperature, time of the year and social factors such as the number of animals per cage.

7.63 Fourteen institutions out of those surveyed by the

Committee reported that such tests had been undertaken over the five year period 1980-84. In most cases the number of tests

conducted by any specific institution was not large. It was not clear from the answers whether the tests were conducted under contract to manufacturers or were University initiated research.

117

7.64 The CSIRO during 1986 called for a review of the test .

It does not currently use the test but has done so in the past t o

establish the toxicity of naturally occurring plant or microbial substances suspected of being the cause of domestic animal

diseases and to obtain the toxicity of pest control agents for

both target and non-target species.

7.65 The design and conduct of LDSO studies by CSIRO staff t o

establish the effect of 1080 baits on non-target species preceded the establishment of ethics committees within CSIRO. The project was specifically designed to reduce the number of animals used to an absolute minimum. CSIRO argued that although the studies

undoubtedly caused pain and suffering, the knowledge gained should enable the use of 1080 in controlling feral animals in a manner which minimises losses among non-target species.

Current Status of the LDSO Test

7.66 A number of professional societies and

inter-governmental bodies have taken positions recently on the LDSO Test, including the National Society for Medical Research,

the Society of Toxicology, Canada and the British Toxicology Society.

7.67 There is substantial agreement that only in very rare

circumstances is the precise determination of the LDSO

scientifically justifiable. Procedures that allow the

classification of toxicity without the determination of the LDSO

7.68 According to the British Toxicological Society:

... acute toxicity tests should be carried out with the objective of examining a few animals in detail rather than many animals for

statistical purposes. Thus for example the

determination of accurate LD50s would not

118

appear to be necessary in the drug industry.

Acute toxicity tests with minimal numbers of animals and a full description of toxic signs should be adequate for drug development and registration purposes.30

Alternatives

7.69 Tests providing the same information have recently been developed using as few as ten animals: that is, a three-fold to

ten-fold reduction.

7.70

The development of an in vitro test system for general acute toxicity will be very difficult. Combining in vitro data with computer

modelling would probably be the most promising approach ... it will take much money and many

years to develop and validate an alternative which will replace animals in LDSO testing .. 31

Testing for mutagens, carcinogens and possibly

teratogens seems to represent a more promising area f o r the

development of non-animal alternatives.

7.71 Sciences: According to a presentation to the New York Academy of

In establishing non-animal alternatives, two important criteria must be met:

(1) The alternative test, if implemented on a routine basis, will not result in a health risk to humans greater than that presently permitted by use of the animal model.

<2> The introduction of the alternative test will lead to greater efficiency in the assessment of the particular toxic endpoint than currently available

animal models.

In the case of genetic testing, these t wo

criteria appear to be attainable.32

119

7.72 Consider, for example, a comparison of the test

performance of short-term tests for genotoxicity with the

standard rodent bioassay for identifying human carcinogens. The results show that there is approximate equality between the two tests in making an accurate designation.33 Neither test is a

perfect model but there appears to be no loss in the ability to

protect humans from carcinogens when non-animal techniques are used.

7.73 The OECD Ad Hoc Meeting of Experts on Acute Toxicity

Testing (Paris 7-11 April, 1986> made the following

recommendations that would reduce the number of animals required in LDSO tests and refine the techniques used so as to limit

animal suffering:

(a) Acute toxicity test guidelines (i.e. OECD> 401 and 402 should be amended so that:

i> oral and dermal tests are carried out

on one sex only (with a subsequent

check on toxic response of the second sex).

This should almost halve the numbers of animals used.

ii> the limit test dose by the oral method

is reduced from 5000 to 2000 mg/kg

which is a more realistic dose.

A limit test which results in

mortality needs to be followed by a

full acute toxicity test. The proposed reduction in the limit dose will

result in fewer limit tests being

followed by full tests and thus will

achieve an appreciable reduction in the number of animals used .

iii> animals which show severe pain and

distress are humanely killed in order to reduce suffering.

120

Additionally, three new

which reduce numbers

required, and/or possible should be distributed

countries for evaluation experience in their use.

Regulatory Action in Australia

approaches of animals

suffering, to Member

and to gain

7.7 4 The Department of Community Services and Health

e xplaine d the development of its policy on the requirement for the LDSO t est:

At the time of writing of the 1984

Departmental submission , the oral LDSO was required. At that time, although it was seen

that the LDSO test was probably approaching obsolescence, on balance it was thought that there were good reasons for continuing with the test for the immediate future.

However, shortly after that submission was forwarded to the Committee, data requirements were reviewed and it was decided that the LDSO should no longer be required. This requirement was therefore removed. In its place was

substituted the requirements specified by Dr Imray at the hearing before the Committee.

With regard to therapeutic substances, the

submission states: '3.6 The general Australian guidelines do not include the LDSO test ... '

The Department's policy, therefore, is that the LDSO test is not required. As stated at

the hearing before the Committee, this would not prevent companies submitting data from including previously-generated LDSO data. If such data were to be included it would be of

value in defining the toxicological profile of the chemical concerned. However, the

Department's position is that it does not need LDSO data.34

7.75 Recently, regulations have been made in Victoria under

the Prevention of Cruelty to Animals Act 1986. Regulation 24

deals with the Draize Test and Lethal Dose Testing and reads as follows:

121

7.76

(1) A person must not carry out any scientific procedure or series of related scientific

procedures known as the Draize test to

determine the relative irritancy of a chemical or a cosmetic, toilet, household or industrial preparation, using the sac of

rabbits. <2> A perso n must not carry out any scientific procedure or series of related scientific

procedures i nvolv ing lethal dose testing

unless:

(a) the scientific procedure is related to

potentially lifesaving treatment or

research in connection with cancer in

human beings; and ( b) the objective of the scientific procedure cannot be achieved by any other scientific means; and (c) the scientific procedure is recommended

for approval by a Peer Review Committee

established under section 34 of the Act; and the scientific procedure is approved by the Minister; and (e) the scientific procedure is carried out in

accordance with any conditions determined by the Minister.

<3> For the purpose of this Regulation,

'lethal dose testing' is any test for

determining the relative toxicity of a

chemical or a cosmetic, toilet, household or industrial preparation in which the object of the test is to assess the toxicity of the

preparation against a predetermined level of mortality .

This regulation has however been subject to criticism . AFWA submitted:

The banning of the LDSO test in Victoria has

already slowed research in that State and will make it more difficult for the proposed Centre for Toxicology to operate effectively in

Victoria. Experience in the Department of

Pharmacology at Monash University indicates that it will lead to increased usage of

animals rather than to a decrease.35

122

7.'77 The Minister for Local Government and Planning in New

South Wales announced in November 1988 his intention to propose amendments to the Chemical Research Act to restrict the conduct of certain tests in particular the Draize and LDSO tests.

Applications to conduct such tests would be referred to the

Animal Research Review Panel for review and would be subject to ministerial decision.

7.78 test.36

7.79

CSIRO has also called for a review of the need for this

On 11 October 1988 the United States FDA stated of its

current policy on the LDSO test:

7.80

The statement provides a short historY, of

FDA's policy on the "classical" LDSO,

including the fact that the agency revoked all regulatory requirements for the "classical" test in 1985. However, FDA "may not refuse to accept or review data, including acute

toxicity data from the 'classical' LDSO test, if they are relevant to a decision FDA must

make on the safety of a regulated article ...

Thus, FDA cannot revise guideline test

protocols or regulations to state that it will never use or consider any 'classical' LDSO

data in making safety determinations."

The policy further states, "The scientific

community agrees that the 'classical' LDSO test is not necessary for determining acute toxicity. In agreement, FDA has adopted the policy that the 'classical' LDSO test is not a required toxicity study. The agency supports efforts to eliminate continued conduct of the

'classical' LDSO test and to reduce the number of animals used in acute toxicity testing

without sacrificing information necessary in the interest of human safety . " (NABR Update, Vol.9, No.22, 18 October 1988, p.l>

The Draize test is banned in Victoria and is subject to ministerial approval in New South Wales. It has been criticised on its effectiveness and on animal welfare grounds. It is also a

123

test which has been little used in Australia. The Committee

believes that the Draize test is undesirable and RECOMMENDS that the Draize test be banned in Australia.

7.81 The Committee RECOMMENDS a ban on the classical LDSO

test in Australia but that acute toxicity tests be allowed with ministerial approval. The classical LD50 is no longer required for registration purposes and is subject to ministerial approval .

7.82 For registration purposes, data derived from Draize

tests or LD50 tests done overseas should still be accepted,

provided that the relevant authorities and their advisers are satisfied that the data are valid.

124

CHAPTER 8

THE USE OF ANIMALS IN AGRICULTURAL

AND WILDLIFE RESEARCH

Agricultural Research

8.1 Animal experiments for agricultural purposes are

conducted by a number of universities as well as departments of agriculture in each State and the Northern Territory. No

comprehensive statistics of the number of animals used in

agricultural research are available.

8.2 The CSIRO supplied details of the use of animals for

agricultural research during the period 1981-82 to 1983-84. In this three year period, 40,042 animals were used. Of this number, only 15.8 per cent of cattle and 43.8 per cent of sheep were

involved in laboratory tests, while the balance underwent

husbandry tests . According to the explanatory note provided by the CSIRO the distinction between laboratory and animal husbandry tests is that:

In laboratory tests it is taken that some

intervention to the animals occurs, eg

injection, bleeding, or dosage of a drug or

infectious Agent. In animal husbandry tests, animals are subjected only to normal farming practices, with the possible exception of

occasional weighings, for example in an animal breeding trial.1

8.3 Although the main aim of agricultural research involving animals at the CSIRO is to improve productivity and reduce costs in the livestock industries, many of the projects have resulted in improvements in the welfare of animals. For example, research at the Division of Animal Health has produced benefits for both humans and various species of farm animals:

125

8.4 animals welfare

The Division directs its main research effort towards alleviating the major bacterial and parasitic disease problems of the grazing

sheep and cattle industries, with some

research into pig and poultry diseases.

Emphasis is placed on the production of new

and improved vaccines and vaccination

procedures and the genetic basis of disease resistance in animals.2

.In the

are used of the

departments of agriculture in agricultural research to animals and the economics

and universities, improve both the of the livestock

industries.

Types of Experiment

8.5 Many of the farm animals used in at the

CSIRO are not subject to pain or distress. At most they are

likely to experience minor discomfort. As the CSIRO pointed out in its submission:

... the techniques applied are the same as, or

very similar to, those used by farmers and the standard of general management is usually

better. These include experiments to evaluate improved pasture species, grassland management techniques or the results of selective mating of animals which show superior performance for

some productive character.

In such cases the research techniques are

mainly ways of measuring production, e.g.

weighing animals; dyebanding wool; weighing fleeces at shearing; measuring milk production from cows or ewes milked by machine or

manually; and measuring meat production

through carcass measurements following

slaughter. Additional methods may involve collection of samples of blood, urine, faeces or tissue

anaesthesia>, the injection of

radioisotopically labelled substances in concentrations not hazardous to the animal or the operator, and oral dosing with an inert

marker substance for measurement of faecal output.3

126

8.6 Some animals are restrained in metabolism crates in the

course of nutrition experiments. Normally the animal is able to move and lie down but cannot turn completely around. The reason

for such restraint lies in the nature of the research.

8.7 In a number of institutions, sheep have fistulae created

which are fitted with cannulae or tubes into parts of the

alimentary tract to enable samples of the contents to be

collected regularly from living animals.

8.8 The purposes of these interventions include the sampling of rumen contents for nutritional research, the study of

micro-organisms within the rumen, or the introduction of

substances directly into the rumen. According to the evidence before the Committee such animals tend to live out a lifespan

which is normal for the species and remain in good health and

body condition.4

8.9 The types of experiment which have caused the most pain

and distress to the animals involved were mainly designed,

paradoxically, to find better ways to relieve or prevent pain and distress in farm animals. These experiments involve research into animal diseases including the establishment of their cause, the efficacy of new methods of treatment or prevention; and the

investigation of poisoning in grazing animals caused by plant associated toxins. An example of the first category is research into foot rot in sheep and of the second is the research into

annual ryegrass toxicity.

8.10 The second category relates to toxins which cause

extensive mortalities in grazing animals. When a new poisoning problem arises the only way to determine whether a given feed or sample of feed is toxic is to actually feed it to the species

concerned. Identification of the specific toxic compound will require still further feeding of extracts of the original feed to animals until it can be concentrated and separated out from the range of compounds present in the original feed. Once the toxin is chemically defined, chemical assessment methods may then replace the use of animals.

127

8.11 CSIRO identified the following principles which it saw

as essential in designing such experiments:

8.12

The minimum number of animals is used; with

toxins that appear to cause pain, every effort is made to use end-points other than pain and unpleasant death to the animal; and analgesics and anaesthetics are used if undue pain is

apparent at any stage.5

The fact that animals will be the direct beneficiaries of such research does not remove the need for rigour and

thoughtfulness in the application of such principles at the stage in the planning of such experiments and in their assessment by ethics committees.

8.13 An example of the need for rigour and experimental

design is provided by an experiment drawn to the attention of the Committee in the ANZFAS submission:

8.14

Example Ellis, T., et al, Protection of

recently shorn sheep against adverse weather using plastic coats, Aust Vet J 62 [no.7,

1985) 213-217.

Recently shorn sheep were cold stressed by

continual wetting in a cool room, with fans to simulate wind, in order to test the protective effect of plastic coats <'polyethylene rubbish bin bags'). There were four groups of ten

sheep. One group were kept dry and exposed

only to room cooling. Another were give coats after 10.5 hours, by which time they were

hypothermic. One did not improve and had to be killed after 2.5 hours. One group had coats

from the start of the wetting. One group were wetted but not given coats. The stress was

continued for 90 hours. Several sheep became severely hypothermic and depressed and were killed.o

Commenting on this experiment, Dr Alexander, who

appeared for AFWA, said:

I think we could say that there are probably

better end points than death, or more humane end points than death. I think that experiment could have been refined, from an ethical point of view ...

128

The point I am trying to make is that the same

result could have been got with perhaps a more humane end point, rather than going to the

death of the animal. The body temperature

could have dropped a couple of degrees and

they could have obtained the same result.?

8.15 It is evident that in the years since those experiments

were done, a greater awareness of animal welfare has changed

attitudes to pain and distress in experiments . Some experiments once condoned will no longer be acceptable to experimenters or to ethics committees. CSIRO, as a co-sponsor of the Code of

Practice, has taken a number of steps in recent years to improve animal welfare in research projects under its control.

8.16 The effectiveness of the vetting by ethics committees of State Government experimental projects involving farm animals is not so clear. The Committee looks forward to the enactment of

legislation in the States which have not yet upgraded prevention of cruelty to animals legislation to ensure that such

experimental projects are approved by ethics committees

established and operating in accordance with the guidelines set out in the Code of Practice.

8 . 17 Although the Committee has primarily used CSIRO

evidence in this chapter, it did notice during its inspections of animal houses a number of similar experiments taking place. The comments in this chapter apply not just to the CSIRO but also to

other institutions or government authorities which use animals in agricultural research.

Experiments Involving Native and Feral Animals

8.18 There is relatively little research done in Australia

which involves native animals. Scientists gave a number of

reasons for the use of any native animals in experiments. First, there are the benefits to humans arising from improved

understanding of biological processes of native animals. This relates to the use of native animals in biomedical research.

According to the NHMRC:

129

By studying native fauna, basic knowledge of biological systems that have general relevance to mammalian biology, agriculture and to human medicine will be gained. Some examples

include:

- the genetic control of sex determination and the hormonal control of sexual differentiation and descent of the testes; ...

- the influence of lactation on mammalian

reproduction;

- the mode of action of hormones in inducing

gene expression for milk protein synthesis, using the peculiar properties of the marsupial mammary gland;

- investigation of differentiation and

development of the nervous system, with the

potential for understanding and subsequently alleviating nervous disorders in man and other animals; ...

- use of parasites and diseases of native

mammals as laboratory models in studies aimed at alleviating human morbidity and controlling human diseases.8

8.19 Proponents of the use of native animals in experiments

acknowledged that the quest for improved biological knowledge is restricted by ethical considerations. The NHMRC admitted that public sensitivity about the use of native animals in biomedical research suggests that the limits of public acceptance in this area may be narrower than in research using other species.

8.20 Experiments are also conducted on wildlife to obtain

more effective and humane methods of controlling them with less detrimental effects on non-target species. Within this area of research specific projects may present difficult decisions for an ethics committee, such as research using traps to check on the

contents of dingos' stomachs and LDSO tests to examine the effect of 1080 baiting on non-target species.

8.21 Finally, information from experiments can lead to

improvements in the management of habitats and the ability of authorities to conserve endangered species with consequential

130

benefits to native animals. The conservation of native species is of concern to scientists and animal welfare organisations. ANZFAS expressed the view that it:

8 . 22

endorses such scientific research which results in direct benefits to indigenous

species, whether those benefits arise from research into disease control or other such applicable knowledge, thus enhancing the

well-being and conservation of native species, but only where no pain or suffering is

inflicted in the pursuit of such knowledge. This type of research should be merely

observing native animals in their own

environment or involve animals which are

themselves already diseased and which

therefore would benefit in their immediate treatment from the experiment.9

When representatives of ANZFAS were questioned on the Federation's policy, Dr Hampson replied:

I think the ethical point there, which needs

to be taken into consideration, is that as far as I am aware most species that are endangered at the current time are endangered because of what we have done. They are endangered because we have interfered with their habitats, for

example, or because we have interfered with other species that have upset the balance in such a way that species have become

endangered. I do not see that there is a more

pressing ethical point for protecting an

endangered species than for saving life in

general Tqe ethical point here is the

degree of invasiveness of the experiment that you are going to do in order to save the

endangered species. I would find it hard to

imagine experiments where you would be killing endangered animals in order to save endangered animals, for example. You would be far more

likely to be doing something that is done out in the field and is less likely to be

invasive, and so on.lO

Supply, Handling and Husbandry

8.23 Most native animals are protected by State and Territory laws which make specific provision for the issue of licences for scientific research. All proposals to capture fauna in the wild

131

are subject to the approval of the responsible fauna authority . Before capturing native animals, an experimenter must obtain a permit giving details of animal species, numbers of individuals and the location of the proposed capture.

8. 24 It is now standard practice for State and Territory

fauna authorities to require the experimenter to obtain approval from the ethics committee of the institution at which the

researcher is based before a permit is issued.

8.25 Although there is no formal co-ordination between the

fauna authority and the ethics committee, no evidence was

received by the Committee indicating dissatisfaction with this system . Nevertheless, ethics committees might consider co-opting officers of the fauna authority to assist in the assessment of

particular wildlife research followed successfully by the projects. This practice has been CSIRO Division of Rangelands and

Wildlife Research Animal Ethics Committee at Gungahlin in the Australian Capital Territory.

8.26 There are, however, problems specific to the handling,

care and supply of native fauna which are dealt with in this

chapter because of their bearing on the argument as to whether native fauna should be the subject of research outside their

natural environment.

8.27 The problems encountered in the capture, handling and

care of native fauna, are often different to those for

purpose-bred or domesticated animals used for experimental purposes. A working party of the NHMRC warned that:

Investigators should bear in mind, however, that interactions between the stresses of

capture, restraint and housing, artificial nutrition, anaesthesia and pre-existing

illness may affect experimental parameters.!!

132

Observational Studies of Wild Animals

8.28 Even apparently unobtrusive observations of wild animals may have an undesirable impact on breeding behaviour. Mrs Large appearing for the New South Wales Government's Animal Welfare· Bureau commented:

8.29

There may be no actual suffering inflicted on the animals by that observation, but there is the potential for that observation to disrupt, say, the reproductive cycles of those animals, with catastrophic consequences, perhaps, for endangered species.12

This point is emphasised by a British scientist

Dr C.M. Perrin who in consideration of ethical issues raised by field experiments offered the following example:

an observer who can be seen by a nesting

bird may cause the bird to reduce its visits

to the nest or to desert the nest altogether. Even walking along a beach at low tide in

mid-winter may seriously interrupt the very limited time available for feeding by wading birds. At such critical periods of the year if enough people do this the birds' survival may be jeopardised. From the scientific viewpoint

it is essential that the observer tries to

understand the effect of his own behaviour on his study animals and to minimise it or make

allowances for it: without this insight the

whole study may be invalidated.13

Marking of Fish, Birds and Animals

8.30 Techniques used for marking animals include tagging,

freeze branding or toe clipping. These all involve catching the animal, marking it and releasing it within its original

territory. The techniques of trapping, are of course species and location specific. The stress involved will vary with the

specific techniques of trapping and marking and the species

involved.

8 . 31 Whatever the technique involved, frequent recapture of

marked animals is required in order to allow for repeated

observations of the individual animals. 133

8.32 The alternative to the repeated trapping and handling of individual wild animals with its associated stress is the use of individual marks that can be seen and identified at a distance. The limitations are that it can only be carried out in a

restricted number of individuals because of the difficulties of making individual marks easily recognisable. Examples of markings include the use of colour rings, wing tags, ear tags, collars and the dyeing of hair or feathers.

These techniques considerably reduce the

stress of repeated catching but, by their

nature, the rather more striking markings may have other deleterious effects . As many as

eight colour-rings have been put on individual birds, back-tags on grouse have been thought to destroy their camouflage and make them more at risk to predators . It has been sugges'ted

(actually without good evidence> that the neck collars used on swans may reduce the nesting success by making it more difficult for such individuals to obtain a mate.14

Radio Telemetry

8.33 This technique is used for tracking of wild animals. It

enables a large number of observations to be made of the

movements and behaviour of an individual animal without the need to recapture it .

8.34 have

Miniaturisation of the transmitter and its power source largely dealt with one aspect of intrusiveness by

substantially reducing the size of the equipment . .

Capture

8.35 Some species of native fauna are bred in captivity for

research purposes. Even if breeding were more widely undertaken this would not be suitable for projects oriented toward research into the behaviour and functioning of animals and birds in their natural environment.

134

8 .36 Trapping presents its own set of difficulties,

.irrespective of whether the intention is to obtain a live animal o r a dead specimen, particularly guaranteeing minimum pain where

d eath is intended and minimum stress when capture is desired. Trap surveillance needs careful thought to prevent unnecessary pain or distress. There is also the problem of minimising the

capture, death or maiming of non-target species.

Conclusions

8 . 37 only that

The Committee believes that endangered species should be subject to experiments which are designed to conserve species. Such projects should be subjected to careful

scrutiny to ensure that the research projects are well founded and are likely to have positive outcomes for the endangered

species.

8.38 Experiments on other wildlife, particularly native

fauna, should also be examined carefully by ethics committees to ensure that the scientific merit and value justify the use of

such animals. Wherever possible, purpose-bred animals must be used. The use of native animals in experiments can evoke emotive responses within the community and protocols involving native animals need to be dealt with sensitively. The added stress of

capture and confinement of wild animals is an extra dimension which must be taken into account in the consideration of

protocols.

8 . 39 The Committee does not support a complete ban on

experiments that might cause some pain or distress to wildlife. However, experimenters must have a very good case to justify

experiments which do cause pain or distress. In no event must

such experiments cause more than minimal pain as required under the Code of Practice.

8 . 40 Special attention must be paid to the planning and

assessment of projects involving the holding of captured native fauna for any period of time. The Committee endorses the

following guidelines laid down by the NHMRC. 135

8 . 41

with the

4. Animals should only be taken from the wild if animals bred in captivity are not available or are unsuitable for the specific research

purposes. 5 . If it is necessary to capture animals from

the wild, steps must be taken. to minimise the distress caused to the animals. 6 . Research institutions and funding bodies should work towards the establishment of new breeding colonies and to the development of

improved husbandry techniques within those colonies. 7. Endangered animals should only be used

when the research will be of direct benefit to the conservation of the species and will not further endanger the species. 8. Investigators must seek expert advice

prior to applying to the AEEC. They must

thoroughly acquaint themselves with details of the appropriate care, housing and diet for the species to be studied. Handling techniques and experimental methods may differ from those used with other laboratory animals 'and

extrapolation of existing techniques for those animals may not be appropriate.15

The Committee RECOMMENDS that ACCART in co-operation relevant bodies with specialist knowledge draw up guidelines and standard operating procedures for the wildlife and their housing, nutrition and management appropri ate capture of

in captivi ty.

Wildlife Research in Australian External Territories

8.42 Questions were raised in the Senate on 18 February 1988

and 22 February 1988 concerning the conduct of wildlife research in Australian Antarctic Territories and Macquarie Island.

Subsequently, the Minister for the Arts, Sport, the Environment, Tourism and Territories, commissioned the Antarctic Science Advisory Committee to prepare a report on Research

Involving Animals in Antarctica.

8.43 The matters dealt with in the ASAC report to the

Minister, which was made public in May 1989, fall within the

scope of the Committee's inquiry into animal experimentation. The relevant conclusions and recommendations were :

136

Conclusions

* The techniques used in current Australian research projects involving live animals are justified on conservation grounds and are

being administered humanely. There are no

better humane ways of collecting this

information which is needed for the

development of conservation strategies. There is every reason, on conservation and animal welfare gro unds, why the projects currently suspended should be allowed to continue.

Valuable scientific information will be lost if they do not proceed. The activities of

Australia's Antarctic researchers have been commented on favourable by an observer from the Australian Conservation Foundation.

* Australian Antarctic scientists are amongst the leaders in the use of humane methods for

collecting scientific data on Antarctic

animals. To consolidate and continue

Australia's progress in achieving high

standards in wildlife research, there is a

need to develop a code of practice

specifically to cover research on Antarctic animals. There is no international code and

the existing NH & MRC code on animal research is inappropriate. The new code should include provision for an independent animal care and ethics committee which should review

all proposals involving Antarctic animal

research.

* Current legislative provisions governing research activities in the Antarctic are

unnecessarily complex and require

rationalisation and simplification. In the short term there is scope for improved

communication of current requirements to

researchers. In the longer term, there should be a review of current Commonwealth

legislative provisions governing Antarctic activities undertaken with a view to

rationalising them and simplifying their

administration. The Antarctic Division should also implement measures so that there is an

immediate focus of responsibility for

oversight of Antarctic environmental

management. Such a focus should include

scientists, policy experts, logistics

co-ordinators and independent specialists.16

137

Recommendations

* a code of practice be developed to cover

research involving Antarctic animals ... and that this include provision for an animal care and ethics committee to assess future

proposals for Antarctic research projects;

* encouragement be given to research involving the development or refinement of techniques (such as use of anaesthesia and radioactive isotopes) which will enable biological

information to be collected from Antarctic animals with minimum effects to them;

* improvements to techniques for anaesthesia on seals be evaluated as a matter of

urgency in relation to future applications of anaesthetics to these animals;17

8.44 The difficulties experienced in the projects mentioned in the Senate point to the need for assessment of all projects

involving animal research by a properly constituted ethics

committee. Given the endorsement of the Government of the Ross Committee recommendation G26 that 'Commonwealth bodies which breed, hold or use animals in experiments adopt and immediately implement the NHMRC/CSIRO Code of Practice and Guidelines for the Care and Use of Animals in Research in Australia ' , it is a matter of some concern that the Code's requirements with respect to the composition and operation of animal ethics committees had not been implemented within the Antarctic Division. The evidencel8 was clear that while researchers outside the Division were having projects scrutinised by the ethics committee of the institution of which they were members, those by researchers from within the Antarctic Division itself were not.

8.45 The Committee does not believe that evidence was

presented in the report to enable the conclusion to be drawn that application of the Code of Practice to wildlife experiments is inappropriate. The Code of Practice is currently used by

scientists conducting wildlife research in Australia in various environments, including Antarctic research conducted by CSIRO officers.

138

8 . 46 In view of the working party's recommendation in

Appendix G of the Report on the development of a code of practice f o r wildlife research in Antarctica, there was obviously some

confusion as to the nature of a code of practice and its role in

the assessment of experiments on animals.

8 . 47 The working party confused a code of practice

d e tailed guidelines. A code of practice sets out

with the

administrative arrangements for approval of protocols; the

r e sponsibilities of experimenters, ethics committees and

i nstitutions; and the principles under which experiments on

animals should be carried out. It does not prescribe the actual techniques, procedures and practices which experimenters should carry out on animals in the field. These should be set out in a

separate document.

8.48 The Committee RECOMMENDS that Antarctic research

protocols be assessed and approved under the Code of Practice and that additional detailed guidelines be drawn up on the

techniques, procedures and practices to be used by experimenters on animals in the Antarctic.

139

CHAPTER 9

ANIMAL HOUSE FACILITIES AND THEIR MANAGEMENT

Introduction

9.1 The standard of care given to animals used in

experiments and the standard of facilities in which they are

housed have an important bearing not only on the welfare of those animals but also on the scientific data derived from experiments in which the animals are used.

9.2 In the course of this inquiry the Committee paid

particular attention to the standard of facilities, training of staff and the quality of animal care. To this end it conducted

inspections of a range of animal houses in institutions in which animal experimentation was being conducted.

Animal House Facilities

9.3 The answers to the questionnaire gave the Committee a

general picture of the standard of animal house facilities.

9.4 In specialist research institutes, there was reasonable

satisfaction by respondents with the standard of facilities. None of the respondents reported any need for more than minor

upgrading. Difficulties with prominently. maintenance

141

did not feature

9.5 facilities In research units in hospitals, the standard of

varied sharply from institution to institution . Se veral hospitals reported that major upgrading was necessary.

Th e se included the Royal North Shore Hospital, Westmead Hospital

and Pr ince Henry Hospital

maintenance.

9.6 A number of universities reported the need for major

programmes of building replacement, upgrading of current

facilities or substantial expansion of animal house facilities. The need for some of these programmes had initially been

identified in reports prepared within the universities up to a d e cade previously.

9.7 Since 1985 a number of universities have undertaken or

announced plans for renovations or, in a few cases, for new

facilities. These include: a new sheep house at the University of Tasmania; refurbishment of the Medical School Animal House and the partial barrier unit at the University of Adelaide; a new

animal house at the University of Sydney; refurbishment of

facilities at the University of Melbourne; new facilities for dogs and other animals and the completion of a specific pathogen free rodent production unit at the University of New South Wales.

9 . 8 Other universities which identified the need for major

programmes of renovations were James Cook University, Griffith University, the University of Wollongong and the Australian National University.

9.9 Even in universities where the central facilities were

of a high standard, there were often small holding facilities

wi thin departments which were far from satisfactory. In one case

the animals were housed among the foundations of a building in

142

conditions that raised concern not only for the welfare of the animals' but also for the staff.l At the time of the Committee's i nspection of this facility, a new animal house was being built.

9.10 The difficulties experienced in maintaining satisfactory standards of accommodation were common to almost all of the

universities. The source of these difficulties lies in a

complicated web of institutional and attitudinal factors and is not simply the result of recent financial stringency.

9.11 In a paper delivered to an ANZAAS Conference in 1982

Dr M. Rose stated:

Far too often animal facilities and personnel are placed at the bottom of a research budget. Even when properly conducted the cost of good animal production is no more than

approximately S-6% of all fiscal expenditure on animal based research programmes. There is a real need particularly in Australia for

significant upgrading of animal facilities and for the prov1s1on of appropriate training

programmes for staff. Part and parcel of this programme is the need to re-educate the

scientific community that the animal house is a laboratory and that animal care personnel are a vital part of the scientific research

team. Far too often the animal facility and

the staff are relegated to positions of least significance in the structural hierarchy of institutions.2

9.12 These points were illustrated in a study of animal house

facilities at the University of Adelaide during 1985. In the

preface to the consultants' report, the Dean of the Faculty of Medicine

The two factors to emerge from the review of

animal services have been the University's failure to recognize the importance of

laboratory research animals for the biomedical sciences and the failure to respond to the

need to upgrade facilities and staffing to

ensure an adequate supply of suitable

143

disease-free animals. By comparison if

computer facilities within the University were permitted to run down to the same extent as

the animal houses with the resultant risk of compromising data, there would be an outcry from the academic community and provision of additional funding would no doubt be approved. The failure to recognize the importance of

research animals has meant that requests for additional funding for animal services have been unable to compete with other areas for

funding . 3

The University responded to the report and implemented many of its recommendations.

9 . 13 The difficulties mentioned in the University of Adelaide report were by no means confined to that institution . Dr

Campbell, who gave evidence on behalf of the Society

for Medical Research, commented:

I think this is a problem with medical

research funding in Australia. Funds are not specifically allocated for improvement in animal housing facilities or in the employment of well qualified people to look after those animals. I think that with the general

downgrading in the level of funding for

capital equipment in universities perhaps the university animal houses have suffered even more. I think that a better outcome for

animals in medical research will come when it is recognised that special allocation of

funding has to be made for that purpose.

Research grants or project grants given by the National Health and Medical Research Council are not given on the basis that animals are

going to be housed any better.4

9.14 There has been some evidence of changes in attitude by

institutional managements towards the need for high standards of facilities and care for experimental animals. This is also

reflected in the higher priority being accorded to the upgrading of animal houses in a number of institutions.

144

Standards for Accommodation

9.15 The Code of Practice does not lay down detailed

standards for animal care facilities. The guidelines most

commonly used by Australian institutions appear to be the

Canadian Council on Animal Care Guide to the Care and Use of

Experimental Animals the U.S. Department of Health and Human Services, National Institute of Health Guide for the Care and Use of Laboratory Animals and the UFAW Handbook on the Care and

Management of Laboratory Animals.

9.16 In its submission ANZFAS recommended that, by statute,

provision should be made for legally enforceable national

standards of laboratory animal welfare such as:

housing appropriate to the physiological and ethological needs of the species and

strains. This would include, for example, temperature, humidity and lighting

specifications, bedding, exercise, social contact, features for the fulfilment of

behavioural needs and for designated species unlimited access to outdoor areas. For

example, animals suitable for confinement in cages should not be housed in cages which

are substandard or too small. Animals'

exercise requirements should be met. For

example, dogs should at least be provided

with an adequate outdoor run and not be kept in cages; and native fauna and primates

should be provided with adequate outdoor facilities general observation individually of all

animals not under experiment at least once every 12 hours

· frequent observation of all animals under experiment or post-operative care by persons competent to alleviate any pain or suffering. The

frequency of observation should be

stipulated according to the species, the

experiment and the severity of the procedure in each case

145

pain or suffering relief techniques by

species

methods of euthanasia by species

the definition of adequate food and water

· the procurement of animals.S

9.17 This recommendation raises an important philosophical issue concerning the role of law in encouraging good practice and the development of appropriate attitudes. Put briefly the

argument way of

is that detailed prescription is not the most effective developing responsible attitudes and facilitating improvement in husbandry practices. Over-emphasis on prescription often leads to an attitude of compliance with the letter of the

law rather than its spirit. The development of such an attitude would hardly be beneficial to animal welfare.

9.18 It is often impractical to incorporate detailed

standards of care into regulations. In many cases, the care

needed is dependent on the nature of the experiments to which the animals are being subjected. However, it is important that

general principles of care are included in regulations to provide a recourse by government if institutions do not adhere to

standards of practice which have been accepted as a minimum level within the scientific community. These general principles are mainly documented in the Code of Practice but some State

Governments may decide to include additional requirements in regulations.

9.19 There is not always unanimity of opinion on the

preferred practices in some areas of animal care and handling. Current knowledge in other areas of animal care is deficient. For example, rodents are probably the laboratory animals whose needs have been most studied.6 Yet it has been pointed out that even for rodents the standards for ventilation and lighting

needed to be more specific and relate to cage as well as room

conditions:

146

9.20

although for factors such as sound level there is ample evidence that the animal's

comfort and well-being can be adversely

affected, the information available is

inadequate to permit any but the most general recommendations to be made.7

A more recent study, which was conducted for UFAW to

determine the size of cage, stocking density and the social group that would make for the well-being and comfort of growing young adult laboratory rats, raised serious doubts about the adequacy of previous guidelines to meet these welfare needs.S There is a danger of imposing standards through a legal or quasi-legal

mechanism which may subsequently be found to be inadequate or detrimental to animal welfare.

9.21 Because the Committee does not ,support the

recommendation of ANZFAS to incorporate national standards of laboratory animal welfare into legislation, the conclusion should not be drawn that the Committee in any way condones lower

standards than those inherent in ANZFAS's recommendation. The Committee believes that a less prescriptive approach will

ultimately be more successful in achieving high standards of animal welfare. Under existing laws in some States and in

recommendations in this report, there are administrative

mechanisms for monitoring standards to ensure that standards are maintained or improved. This approach should meet the desired outcomes better than the prescriptive approach.

Quality Control

9.22 There has been an increasing awareness of the importance of precise biological definition of animals in animal

experimentation. In a paper delivered to a seminar at the

University of Melbourne in 1987, Dr M. Rose stated:

147

The biological definition of animals is

arguably the single most important

consideration in reducing the numbers of

animals used. Animals are complex entities

whose biological responses reflect the

interaction of their genetic make-up with a multiplicity of environmental variables. It has long been recognised that control, and/or definition of their genetic and health status,

and of environmental variables, is an

important consideration in the use of animals in research.9

In that paper Dr Rose drew together

number of scientific studies which

the findings reported the of a lar g e

effects o f

environmental variables on animals and the ramifications f or research. Some of the variables included light, noise ,

temperature, humidity, diet, noxious gases (e.g. ammonia >

contamination of feeds, type of bedding, chemicals used in

cleaning agents and pest control, social interactions with other animals and humans, size of groups, design of pens and so on.

Each variable might produce a biological response which could affect experimental data.

9.23 Apart from environmental influences, there are also the

effects of infections which, too, can distort experimental dat a .

According to Lussier and Descoteaux:

The importance of viral infections as

complicating factors of biomedical research is recognized widely.lO

In their six year study on the prevalence of viruses in 32

Canadian institutions, they concluded:

virus infections of mice and rats are

extensive and widespread in Canadian research institutions. Experience has shown that the above mentioned viral infections are good

indicators of the standard of husbandry and

148

9.24

management. The results presented here

indicate then that standards have to be

revised and that efforts have to be made to

improve the quality of the rodents used in

biomedical research.11

Apart from the prevalence of viral infections in

laboratory animal colonies, genetic contamination of laboratory animals has become a problem in biomedical research and

toxicological testing. In some areas of research, specific

strains of animals are required because of unique

characteristics. In other cases, the inclusion of the name of the strain in the published results of a research project is

essential to enable the data to be reproducible. Concern has been expressed that animals obtained from some animal breeding

establishments overseas have not been of the right strain. This has resulted in significant losses of money, animals and time.12

9.2 5 Monitoring of health microbiological and genetic status as well as of diet and other environmental factors is essential for both the welfare of the animal and the validity of the

experimental results.

9.26 The importance of three basic elements - records,

evaluation and surveillance were emphasised by Dr J. Adams,

Director of the Monash University Central Animal House. He

stated:

Quality control occurs at three levels. The first level is indeed at the level of actual

records. I will refer the Committee to a

publication which is cited and still cited

indeed in the NHMRC guidelines entitled Notes for Breeders of Common Laboratory Animals. It was published in 1962 by George Porter and

Professor Lane-Petter. In that they talk

basically about procedures and what should be occurring. The first topic relates to record keeping and on page 201 they say that proper

records shall be kept for the production

149

colony management in order, firstly, to

determine the efficiency of the operation; secondly, to trace the origin and spread of

diseases; and thirdly, to determine biological performance.l3

9.27 Record keeping is important in providing the health a nd

breeding statistics necessary for both microbiological and genetic monitoring. The ongoing monitoring required to maintain high standard animals is substantial. Dr Adams told the

Committee:

9.28

if you wish to produce high quality

animals and you have a defined status clearly in mind, then you would want to monitor and

see whether you have in fact achieved that

goal. That involves routinely bleeding animals for viruses - there are 17 or 18 viruses in

mice and rats. You would also routinely check them for the common bacterial and

parasite-type pathogens that exist in these animals. You would also carry out routine

quality control checks using sophisticated scientific procedures for genetic quality control.l4

ASLAS has taken an important role in supporting the

upgrading of monitoring facilities available in Australia. There is now a National Murine Virus Serology Scheme based in Adelaide which enables production facilities to monitor the health states of SPF stock with screens available for 15 viruses plus

mycoplasma.

9 . 29 ASLAS has drawn attention in recent years to the need

for the monitoring of animal feed. Much of the feed comes from

feed mills which are mainly concerned with supplying feed to the livestock industries. Feed for laboratory animals is only a

sideline and therefore not a high priority for quality control. Representatives of ASLAS gave examples to the Committee of the effects of either toxic or inappropriate materials in the feed supplied to animal houses.lS

150

9.30 Apart from the obvious animal welfare problems arising

from the use of toxic or poor quality feed, there are more

serious ramifications for the results of experiments in which animals are used that have been fed on such feed. Data derived

from experiments on these animals may be rendered useless because sensitivity by the animals to the feed may cause a reaction which distorts the data produced .

9.31 Because of the seriousness

quality feed for both the animals and

taken steps to have more monitoring of told the Committee:

of the effects of poor

experiments, ASLAS has feed. Dr Kuchel of ASLAS

So ASLAS took it on board to work with an

independent analytical lab to look at diets being fed to laboratory animals throughout Australia, because we recognised that there was a large disparity in reproductive

performance. From overseas work we just knew that some of the diets were likely to be

substandard.

With the 1987 update, recogn1s1ng that these are expensive assays, it costs about $750 to

assay one diet for 24 analytes. That comes out of the animal house budget. It means that the

vet in charge of the facility has to recognise that if you get your diet analysed you do not

do something else. However, it is being done and there are 12 institutions in Australia now where money is put aside to analyse the diets . So the researchers can then be given the

printout, or given some written verification, that the diet has not changed in the last 12

months. We want to extend this to six-monthly testing because the variation in the quality of constituents within diets may well change with season. So we want to get milling

companies to have a fixed formula and to make them realise that their product is being

independently checked. By the time we have the system running, by the end of the fourth year I suspect that the enormous variability across Australia, which has been dramatically reduced after the first year anyway, will perhaps be eliminated.16

151

9.32 On animal welfare grounds

of this monitoring

the Committee regards the significant development scheme as a

development. ASLAS is to be congratulated for its initiative i n this area .

9.33 The Committee would like to see participation in this

monitoring scheme of all institutions involved in laboratory animal experimentation.

9.34 The Committee RECOMMENDS that all institutions which

conduct animal experimentation have periodic analyses done on animal feed to ensure that it is of a high and consistent

quality, not only to maintain standards of animal welfare but also to guarantee the validity of experimental data.

SPF Animals - Facilities, Breeding and Use in Experimentation

9.35 Increasing sophistication in biomedical research over the past two decades has made experimenters more aware of the

range of factors that actually influence the results obtained in research based on animal experimentation. This has led to a

increasing demand for animals whose health and genetic status are closely specified.

9.36 Specific Pathogen Free laboratory animals are bred under controlled and closely monitored conditions. Mr Deeny, then Director of the Animal Resources Centre in Perth, explained that there are advantages for animal welfare and the validity of data in using such animals:

The influence of bacteria, viruses and

parasites - whether pathogenic or not - may

have profound effects on the outcome of

experimental results. Therefore, the use of specific pathogen free animals is of

prime importance in terms of reducing

variables and ultimately in minimising the

152

9.37

numbers of animals used. Organisms such as

mycoplasma pulmonis, which continue to be a problem in conventional rat colonies, can

cause many misleading results in studies and can also reduce breeding efficiency by 50 per cent, are eliminated in SPF colonies.17

The value of SPF animals was reiterated in evidence

gi ven by witnesses appearing on behalf of ASLAS. Questioned about the impact of animal quality on research results Dr Kuchel cited an example from the Institute of Medical and Veterinary Science in Adelaide in which 12 months work was wasted because of a viral infection that got into breeding stock.l8

9.38 ASLAS provided further detailed evidence to the

Committee on the need for the use of SPF animals for experimental purposes. In its view there are very few circumstances in which conventional rather than SPF animals can reliably be used for research purposes.19

9 . 39 Prior to the recent opening of the SPF facility at

Little Bay in Sydney the major SPF breeding unit in Australia was the Animal Resources Centre in Perth. It was set up as a

statutory authority and financed jointly by the Western

Australian Government, the University of Western Australia, Murdoch • University and Curtin University .

9.40 There is an SPF unit at the Walter and Eliza Hall

Research Institute in Melbourne but its output of animals is

mostly, if not solely, for use within the Institute.

9.41 Animals produced in an SPF facility are more expensive

than conventionally bred animals. However, even with substantial freight costs added to the basic purchase price, 47 per cent of

the ARC's income from sales was derived from sales to the eastern States in 1985.

153

9.42 The scientific and welfare value of SPF breeding

operations are not a matter of dispute. Assessment by ethics

committees must deal with the adequacy of the proposed animal model in experimental proposals in the light of the type of

issues raised by ASLAS. Such assessment should also be an

integral part of the evaluation of proposed projects by funding bodies.

9.43 more

SPF units expensive to

establishment of

are capital intensive to construct and are run compared with animal houses. The

additional SPF units would require a

rationalisation of breeding of experimental animals, particularly rodents, among institutions within the region in which new SPF units were established to ensure the economic viability of those units.

9.44 Mr A. Deeny, then Director of the ARC in Perth, doubted

whether Australia has the capacity to support another SPF unit like the ARC, particularly in view of his sales to the eastern

States.20

9.45 The University of New South Wales has recently

commissioned an SPF unit devoted to rodent production at Little Bay in Sydney. In discussing the potential market for SPF animals Professor Ronayne commented:

I did take the decision to go ahead based upon a new survey of user needs, the closing down

of the facility at the Australian Nuclear

Science and Technology Organisation and the possible closing down of the facilities at

Sydney University in Castle Hill. The market for SPF rodents therefore seemed much rosier. I took the decision to go ahead with the SPF

unit and I think the capacity of the unit at

this time, which is 60,000 SPF rodents, will

be fully committed within a year of its

beginning operations 21

154

The Economics of Laboratory Animal Breeding

9.46 Responses to the questionnaire concerning the advantages of breeding within an institution as opposed to obtaining animals from an outside supplier evoked such a wide diversity of opinions that it was not possible to derive a consensus view.

9.47 There were also marked differences in figures provided

to the Committee on the relative costs of internal breeding

compared with purchase from a specialist supplier. The

differences in costs per animal for internal production of a

common species quoted by various institutions may be explained by differences in cost allocation by institutions, in particular, whether caging was included as a recurrent cost; differences in the scale of production; differences in design of facilities and

in the age and design of equipment; and differences in the

efficiency of the management and staff of the facilities.

9.48 Many institutions at the time of completing the

questionnaire were not able to supply the Committee with accurate figures on the relative costs of in-house breeding compared with outside purchase.

9.49 Only seven of the universities had policies that

required researchers to pay for animals and in five of these

cases the policy did not apply to all breeding units within the university. In the course of hearings the University of Adelaide indicated its intention to require payment for animals.

9 . 50 The Central Animal Breeding House at the University of

Queensland, which does charge for animals issued, reported in its Annual Report for 1986 that its subsidy per animal issued for

that year was $5.67. University policy is that the subsidy on

laboratory animal breeding should be eliminated or substantially reduced over the next five years . 22

155

9.51 Monash University has a two-tiered pricing policy. Th e

price of animals for experimenters within the University includes all recurrent costs but excludes any element attributable t o

staffing costs. External purchases are charged at a rate which covers the full cost of staff and administration as allocated t o the specific species.

9.52 The case for charging experimenters for animal s supplied for experimental purposes rests on three grounds. First, payment by the researcher for animals encourages careful planning of experiments and seems likely to minimise the number of animals used. Secondly, if the animal house does not recover costs there

is little encouragement to identify costs and enable assessment of the cost effectiveness of production. Staff cannot be held

accountable for their performance. Thirdly, once charging i s accepted, proper pricing can enable animal houses to accumulate financial surpluses which can be used for capital investment i n animal house facilities. Such investment has the potential to increase the efficiency of animal production. Conversely, low pricing of animals will make the animal house dependent on

university funding which in the past has not been enough to

maintain many animal houses at a high standard.

Rationalisation of Breeding Units

9.53 Except in Perth where the ARC provides institutions with most of their animals for use in experiments, animal breeding and supply is decentralised in Australia. Most institutions carry out some animal breeding programmes for their own use. A few central animal houses in the larger institutions also supply animals to other institutions.

9.54 The question was raised in the inquiry whether the

current decentralised breeding system should be continued or whether there should be a rationalisation of breeding

156

establishments on a regional basis. In essence, it is a question of whether to have a limited number of large animal houses or to

have, as there is now, mainly relatively small ones.

9.55 many

Larger animal houses can achieve economies of scale for species which will reduce the cost of animals for

experimenters. There should also be less wastage from large

orders for animals of the same sex because the discarded animals of the other sex may be used in other projects where a particular sex may not be an important factor. The large and more constant throughput of animals gives managers of animal houses more

flexibility to operate in an efficient way. Dr J. Adams, Director of the Central Animal House at Monash University, explained:

9.56

the operation of small units always .has the problem of economy of scale, particularly where there is fluctuation in demand. The

university finds in this industry that

research workers vary their orders. There are very legitimate reasons why they do that. The logical thing is that, if you want to minimise wastage or the problem of famine and feast in

terms of supply, it is better to centralise

and go for better economy of scale.23

Dr Adams also told the Committee:

the more sophisticated your product

quality control, the greater input you will make to the preparation of your materials or the maintenance of your general environment. So more sophisticated places may have greater

staff input. On the other hand, more

sophisticated places, particularly bigger ones with better economy of scale, are better

suited to the uses of automated pieces of

equipment. Particularly if they have been

purpose-designed buildings, you will have a better flow of materials and better dynamics of operation, which tend to make the carrying out of those basic tasks more efficient. So

sophistication of quality control increases work and the sophistication of man management, building design and the dynamics of operations can reduce the staff input per animal

produced.24

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9.57 By centralising breeding establishments, scarce capital funds can be concentrated on providing high quality facilities with sophisticated equipment rather than being dispersed among many animal houses with a lesser standard of facilities and

equipment. This not only improves the quality of animals bred in these establishments but also it improves the environment for the animals and thus enhances animal welfare. It is essential to have high quality animals in many projects to obtain accurate and

reproducible data.

9.58 A large animal house has a hierarchical staff structure

which affords staff better career prospects and opportunities for training. The greater diversity of species and procedures in a large animal house gives a broader and more interesting range of duties for staff to perform. Technicians will also have more

opportunities to develop more specialised skills. The larger animal houses can employ one or two professional staff who can raise standards of care and develop specialised practices and procedures. With professional direction and advanced technology, the animal house will begin to achieve its rightful status for

the important and integral role it plays in the research

activities of the institution.

9.59 It was argued in the course of the inquiry that by

centralising breeding within a region, the extra handling and transportation of animals from the breeding establishment to the institution would cause additional stress to the animals.

However, many SPF and other animals are currently transported both within a city and interstate without undue problems. The Western Australian institutions also had no criticism of the centralised system operating in that State. Provided that the

animals are given time to recover from transportation and to

familiarise themselves with their new environment, the Committee does not believe that the need for transportation negates the

advantages of centralisation of breeding.

158

9.60 At present scarce funds are thinly distributed over many animal houses, although in the last few years there has been an

injection of more substantial amounts into a number of animal houses, including at least $3.8 million being spent on the new

SPF unit at the University of New South Wales.25 There still

remains a number of animal houses with poor f?cilities or

is not a desirable equipment. situation.

9.61

From a national perspective, this

The Committee has already outlined reasons for

contracting the number of breeding units to make the scarce funds more cost effective and to enhance animal quality and animal

welfare. Committee This contraction is probably

believes a planned contraction inevitable but the

would serve the

scientific community better. It is also essential the large

animal breeding units which emerge are managed by highly

professional and experienced veterinarians with training in laboratory animal science.

9.62 There is probably room for no more than four or five

large breeding units, with ARC in Perth used as a model. As each unit would serve many institutions, it would be preferable for each to be run independently of the institution in which it is

located. The Committee does not have a strong view on whether the large breeding units should be run as commercial or non-profit operations. Non-profit in these terms means that surplus funds are not distributed to shareholders and not that the accumulation of surplus funds should be avoided. In fact, surplus funds would be necessary to develop and maintain the units. Whether run as a commercial enterprise or not, the key element is efficient

management and operation.

159

9.63 strains: Mr Deeny drew attention to the production of little used

we would probably advise the institution that it would be in their best interests to

supply it themselves because the costs would be inordinately high if we bred them. What we are trying to do, however - we have started on

this process now - is to institute a cryo

preservation system within our own facility so that we can· freeze mouse embryos, and also in the future rat embryos, of little used strains so that we can actually keep the animals in

Western Australia without the expense of

having to breed them and to maintain them.26

9.64 The other exception is where the breeding is an integral

part of the experiment itself. The Department of Genetics at

Adelaide University has been engaged in the and

breeding of a species of small marsupial mouse. The close

attention by staff who are engaged in the experLment enabled

results to be achieved which would not be possible in a

large-scale operation.27

Cost Recovery

9.65 The Committee took evidence from a number of

institutions on the question of whether to charge experimenters with the cost of animals or whether to subsidise either fully or partially the supply of animals for experiments. Most

institutions have subsidised animals to some extent but there is a trend now towards greater cost recovery. A number of

institutions now require experimenters to pay for the animals either bred or purchased on their behalf from the grant received for the project.

9.66 Cost recovery makes experimenters more conscious of the cost of animals and encourages them to consider more carefully the number of animals needed to complete the project. If animals are free, experimenters tend to order more animals than they

160

need. There is no incentive for the prudent use of animals.

Hence, there has been considerable wastage of animals over and above normal and inevitable surpluses occurring to meet special requirements, especially in response to orders for a large number of animals of the one sex.

9.67 Cost recovery programmes recover operational costs, some of which include staff costs, but not the cost of depreciation of buildings and major equipment. Some institutions have a two-tier programme where external orders are charged a premium. This

additional revenue is then used to upgrade equipment and other facilities within the animal house.

9 . 68 Cost recovery insulates animal houses from the

vicissitudes of institutional funding, in many

institutions which have given animal houses a low priority in the allocation of funds. With increasing contraction of funds in the tertiary sector, an assured income through cost recovery will enable animal houses at least to maintain, if not increase,

standards.

9 . 69

breeding recovery equipment

The Committee RECOMMENDS that animal house supply and units develop appropriate pricing policies to enable of all recurrent costs including caging and minor

and that surpluses generated should be used to develop animal house facilities.

Surplus Animals

9.70 From answers to the questionnaire and from evidence

received by the Committee, it was revealed that many institutions produce large numbers of surplus animals. This practice has

developed mainly because some experimenters over-order animals or order large numbers of animals narrowly defined for sex, weight and age, resulting in considerable wastage of animals that did not meet their requirements.

161

9.71 Much of the over-ordering by experimenters has occurred because the animals have been supplied free of charge. There has been, therefore, no incentive in those institutions for

experimenters to calculate the minimum number of animals needed for an experiment or series of experiments.

9.72 It was pointed out to the Committee that it is often

difficult for an experimenter to predict accurately the number of animals needed for a project. Sometimes, the design of each

experiment in a project is dependent on analysis of data derived from the previous one. The number of animals needed for

subsequent experiments in these circumstances can often be only an estimate. Experimenters will almost inevitably tend to order more rather than fewer animals to ensure that enough animals are available at the required time. The Committee accepts that it is not always possible to calculate accurately the number of animals needed for a research project. There have to be tolerances

within the system to cater for the unknown and the unexpected, particularly when research is often going beyond the bounds of current knowledge. However, assiduous as they should

requirements.

some experimenters have not been as

have been in estimating animal

9.73 Another factor causing uncertainty in animal

requirements is the dependence of many experimenters on annual grants. As Monash University pointed out:

1. Research staff don't know whether grant

applications have been successful or not.

2. Biological facts require breeding to

commence six weeks to eighteen months in

advance of planned use of animals.

3. Most research work is dependent on

post-graduate students, many of whom have some difficulty in establishing

techniques.28

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9.74 The narrow definition of animals, as mentioned above, is a major cause of over-production. Usually animals of the same sex are required and if there are no orders for the opposite sex, or for either sex, of the same species, surplus animals will be

produced. According to the ARC:

9.75

Australian animal users purchase predominantly female mice. This creates a surplus of male

mice that are culled. In order to attract

additional sales of male mice, incentives,

such as discounted prices, have been

introduced. While females are still the sex

predominantly used, these measures have had a small influence on the numbers of males

used.29

The Committee noted that this predominance was not

universal within Australia as some institutions a bias

for male mice.30

9.76 Mr Deeny, the then Director of the ARC, told the

Committee that his experience in the United Kingdom was the

opposite to that of Australia as experimenters there tended to use male mice.

9.77 It appears from the evidence that some experimenters

in Australia and overseas are unaware that for some types of

experiments, either sex is suitable. In order to avoid wastage of animals, animal houses need to be given as much flexibility as possible in the supply of animals of a sex which will be produced anyway to meet specific requirements. There is obviously a need to educate experimenters about the suitability of the use of

animals of either sex in particular types of experiments. In the first instance, this should be done by professional staff

employed in animal houses. However, given the cost of breeding, maintaining and disposing of surplus animals, a more concerted effort should be made within the scientific community to keep

163

surplus animals to a minimum. The Committee believes that ACCART should arrange for studies to be done to determine whether one or either sex is appropriate to use for particular types of

experiments.

9.78 The ARC told the Committee in its submission that it

provides incentives, such as discounts, in order to secure orders for animals which have to be produced to meet specific

requirements.31 The Committee understands that the Central Animal House at Monash University employs a person to handle external sales and is only involved in the marketing side of the Animal

House's operations. facilitate closer

over-production.

If there were fewer animal houses, it would co-operation among them to avoid

9.79 A statement issued by the New York Academy of Sciences

on the Animal Model Selection was critical of an imbalance

between sexes in the planning of experiments.

9.80

In planning animal procedures, consideration should be given to equal use of females and

males. At present, much research is conducted on male animals; their female littermates, not used for breeding, frequently are disposed of. Results of studies using only males have often been assumed to apply to females as well,

sometimes without justification. The

appropriate use of both male and female

animals may increase the validity of data and decrease animal wastage.32

The Committee RECOMMENDS that a study be undertaken by ACCART to determine the most effective means for production

planning of laboratory animals in terms of minimising excess production.

164

Operating Procedures

9 .81 Few institutions were able to supply the Committee with

a copy of the standard operating procedures governing animal care

within the breeding and holding units. In most cases procedures

did exist but were not written down. Staff were either expected

to know what needed to be done or to respond to oral

ins tructions .

9 .8 2 Without written standard operating procedures, there is

a greater likelihood of mistakes being made, particularly with

n ew staff. Mistakes can have ramifications beyond animal welfare.

A p roject can be put at risk because the wrong husbandry

procedure was performed. With greater emphasis being placed on

the definition of the animal in results of projects published in scientific journals, accuracy is essential .

9 . 83 Each animal house or holding area should have written

standard operating procedures, which are revised when new

inf ormation becomes available to update procedures and practices performed there. Writing of a procedural manual i s time

consuming. The institution should ensure, however, that a

sho rtage of staff does not prevent the task being done.

9 . 84 Institutions licensed in New South Wales will be

r equired by law to document standard operating procedures for

accreditation .

165

Introduction

CHAPTER 10

THE USE OF POUND ANIMALS FOR TRAINING

AND EXPERIMENTAL PURPOSES

10.1 The use in experiments of animals, mainly dogs, taken

from pounds is an emotive issue in Australia. Public concern has been heightened from time to time by the lack of sensitivity

shown by some institutions towards the use and disposal of pound animals.

10.2 In this chapter, the Committee examines the extent of

use of pound animals, the arguments for and against such use in teaching and research, and the controls over that use.

Extent of Use

10 . 3 The number of pound animals used in experiments is

unknown. Not all institutions use such animals and in South

Australia, for example, their use is banned by statute, although the pounds in that State had prohibited the transfer or sale of animals to institutions before legislation was enacted.

10.4 The scale of pound animal use in Sydney is substantially

larger than in other cities. Sydney University informed the

Committee that in 1987 it used 2,000 pound dogs.1 Of these

approximately 75 per cent were used for teaching in the

Veterinary faculty and 25 per cent were used for research.2

167

10.5 The University of Queensland reported that it obtained

11 dogs a week for the 26 teaching weeks in each academic year

for the Veterinary School.3 A number of departments also used dogs for experimental purposes. Between 1980 and 1984 the

Department of Physiology and Pharmacology, the largest user of dogs for research purposes on campus, used between two and 21

dogs annually.

10.6 Murdoch University, the only other university with a

veterinary school which provided figures, reported that it used 574 dogs in 1986.4 It did not supply a breakdown between teaching and research but the figures for previous years were:

Teaching Research

1980 124

1981 182 20

1982 167 85

1983 217 214

1984 113 214

SOURCE: Evidence, pp. S5990, S5992, S5994, S5996, S5998

Use of Pound Dogs for Teaching

10.7 A representative of the AVA explained the background to the use of dogs in the training of veterinarians and the changes in practice over the years. Students used to be required to

perform surgery on anaesthetised animals and then were

responsible for post-operative recovery of those animals.

However, today, once the surgical procedure has been done on the anaesthetised animal, most of the animals are euthanased. Some animals are still allowed to recover to enable students to deal with animals coming out of anaesthesia.5

168

10.8 Although it would be possible to restructure veterinary science courses to avoid conducting experiments on pound

animals6, some witnesses argued that this would lead to a lower standard of training with veterinary students less prepared on graduation to cope with the demands of a veterinary practice.?

10.9 training students cadavers.

Professor Rex of the University of Queensland in the United Kingdom and Australia and pointed in the United Kingdom practised surgery

He went on to say that:

I had no doubt at all that new veterinary

graduates in Australia were far more competent than I was when I qualified because they had

had the opportunity to do surgical exercise as students on live, anaesthetised dogs which did not recover from anaesthesia and were put to sleep at the end of the day.8

compared out that only on

10.10 Dr Smith of the AVA conceded that it would be possible

to have an internship system for veterinarians but that the extra costs would have to be borne by the community.9 Witnesses from veterinary emphasised

faculties generally supported Dr Smith's position and that the additional costs would have to be met by

tertiary funding bodies.

10.11 Another argument put to the Committee against the use of pound animals was that it inculcated in students wrong attitudes about animals; that in effect they are disposable. However, the Committee only received anecdotal evidence on this point. The Committee does not believe that undesirable attitudes would

necessarily develop simply because of the source of the animals. The answer to this difficulty would seem to lie at least in part

in the hands of the lecturers and the attitudes modelled on and taught by them.

169

10.12 In essence, the arguments put to the Committee provide

support for the use of live animals in the training of

veterinarians and do not directly address the issue of the use of pound dogs. It would be possible for institutions to breed dogs for the training of veterinarians. This would, however, be more expensive to do.

The Use of Pound Animals for Experimental Purposes

10.13 Apart from philosophical opposition to the use of

animals in experiments discussed in earlier chapters of this report, animal welfare organisations have raised specific

criticisms of the use of pound animals in experiments.

10.14 It was submitted to the Committee that institutions

using such animals benefit from the current lack of control over breeding of companion animals and the resulting population of stray animals . 10 There is a serious problem with the large number of companion animals which are disposed of each year because they are no longer wanted by their owners. That is a separate problem and should not be confused with the question in hand. The

prohibition on the use of pound animals for experimentation would have no impact on the companion animal problem.

10.15 A more serious argument advanced against the use of

pound animals was that such random source animals may be

unsuitable for research purposes on the grounds that they are poor research models because of their unknown genetic and

micro-biological backgrounds and the confounding effects of many extraneous variables. Mr J. Adams, Director of Animal Services at Monash University, commented:

I think there is another aspect that should be looked at in respect of pound dogs and the

question of quality control in animal

experimentation: Scientists have a moral

170

10.16

obligation to ensure that the animals which they put into an experiment are in fact able

to yield useful data. In some cases pound dogs are not suitable in that respect.ll

Professor J. Egerton of the University of Sydney told the Committee:

In some research projects there may be a

question about the use of this heterogeneous group of animals but in some other projects

they would be quite suitable. Whether or not they should be used in experimental studies, in controlled research projects, depends very much on the project itself. There would be

some research workers who would prefer to have a standardised animal that they could use over and over again if repetition were required. But other people who are looking at other

questions might find the heterogeneous of animals was quite

According to Professor Egerton, the main issue was the

variability of response that one would get to any experimental procedure. He stated:

If you had a group of animals, say 10 animals

of mixed ages, the response in that group

might not really be representative of what

would be achieved if the target group for the research had been an older group of animals. It comes down to the question of the

variability of response that you would get

from this mixed group of animals that might be used in an experimental procedure.13

10.17 The wider the variability of response, the larger the

number of animals that would be required to assure statistically valid results. In other words, random source dogs should only be used for research purposes where it can be demonstrated that

their use would not lead to a greater number of animals being

used than would be the case if purpose bred dogs were used.

171

10.18 ANZFAS expressed concern that pound animals by virtue of their background as companion animals would suffer undue stress and suffering if maintained in a laboratory environment. Undue stress, in the opinion of ANZFAS, not only raises the question of humane treatment but also of the validity of data obtained from experiments conducted on those animals.

10.19

These stress related changes alter the data that an experiment will yield and render its validity unreliable.l4

This argument might apply to some dogs but not to all, as many dogs which find their way into pounds have been abandoned by their owners. Obviously, experiments which might be affected by abnormal stress caused by the new environment should not be performed on those animals.

10.20 ANZFAS argued that the availability of cheap animals

encourages the conduct of experiments which are not properly thought out and the ignoring of possible non-animal

alternatives.lS However, proper evaluation of protocols by ethics committees should ensure the use of non-animal alternatives where it is appropriate. In addition, the costs involved in keeping

animals, whether purpose bred or obtained from pounds, is a

disincentive to use animal& unnecessarily, particularly if the experimenters have to provide for such costs out of their grants.

10.21 The Committee concludes that dogs from pounds may be

used in experiments provided that where dogs are

surrended to pounds, their owners given written consent to their use by institutions. The Committee accepts the argument that if a dog is used in an experiment from which it will not recover

consciousness, there is no difference between euthanasia in a pound and destruction at an institution. If by the use of pound animals, which will be destroyed anyway, there is a reduction in

172

the destruction of purpose-bred animals, then animal welfare is enhanced overall. This argument is based on the premise that

facilities for treatment of the dogs in institutions are of an

appropriate standard. This is discussed below.

Policies of the Pounds

10.22 State legislation provides minimum holding periods for animals in pounds before action can be taken to dispose of them. In Western Australia the holding period for dogs is 72 hours . In Queensland it is 3 days for unregistered dogs and 6 days for

registered dogs. In Victoria the holding period is 8 days bu t a

recently gazetted Code of Practice dealing with t he supply of dogs for experimentation requires that if they are supplied for experimental purposes they be held by the ins titutions to which

t hey are supplied for 21 days b e fore bein g used. New South Wales requirements call for dogs to be held for 7 day s if they are

unregistered or carry no identification and 14 days if they do. Dogs which are voluntarily surrendered do not have to be held for a fixed period.

10.23 The Victorian Prevention of Cruelty to Animals Act 1986 (No.46, 1986> Section 26 <2> prohibited the use of a dog or

cat from a municipal pound in a 'scientific procedure'. This

however was amended by Section 28 of the Agricultural Acts

Act which enables such use if in accordance with a code of practice.

10.24 It would be possible under the New South Wales Animal

Research Act to regulate the provision of pound animals through the requirement to licence animal suppliers under that Act. The Committee understands that a code of practice dealing with the supply of pound dogs for experimentation and teaching is

currently being drafted by the Animal Research Review Panel in New South Wales.

173

10.25 Some pets which are still wanted by their owners may end up being supplied to experimenters. This may be caused by human \

error or by events beyond the control of the owner. The

likelihood of this occurring depends to a large extend on the

length of the holding period at the pound.

10.26 The Committee believes that three days is too short a

period for a registered dog to be held before disposal unless

that dog is surrended by its owner to the pound. For a registered dog, the pound should hold it for at least a week. This should

give owners enough time to contact the pound to retrieve their dogs.

10.27 It is not always clear to owners who take their dogs to

municipal pounds that those animals might be sent institutions to be used in experiments. Some owners may not want their animals to be used for such a purpose. Those wishes should be respected . Pounds that supply animals to institutions must ensure that all people who deposit animals with them realise that those animals might be used in experiments. There should be signs at the pounds

to that effect and owners should also be given a written notice informing them of any such arrangement with an institution .

10.28 Many owners take animals to pounds because they just do

not want them any more. However, some owners dispose of animals for other reasons. They may be moving overseas or into a horne

unit where animals are not allowed to be kept. Although animals may suffer no more in an institution than they do in a pound,

there is sometimes a perception on the part of the owners that

additional distress will be caused to the animal if it is given to an institution for experimental purposes. Whether such a

perception is correct is immaterial. Owners should have the right to choose wha happens to their pets.

174

1 0.29 The Committee RECOMMENDS that State Governments

l egislate so that pounds hold dogs for at least seven days before d isposing of them to an institution except where a dog is

s urrended by its owner.

10 . 30 The Committee RECOMMENDS that State Governments

l egislate so that all owners who surrender dogs to pounds be

inf o rmed in writing of the possible transfer of the animals to a r esearch institution and that pounds obtain the written

authorisation of owners to transfer the dogs to an institution .

Code of Practice

1 0 . 31 The Victorian Government has drawn up a draft code of

practice to cover the use of dogs from pounds in institutions.

Si milar codes should be drawn up in other States where

experiments on pound animals are permitted. Alternatively, State and Territory Governments should issue regulations to contr ol the use of pound animals in institutions.

10 . 32 The draft code of practice provides for a written

agreement between the pound and the institutions which is to be signed by either the Mayor or Shire President of the Council

administering the pound.

Transport of Pound Animals

1 0 . 33 The vehicles in which animals are transferred from a

pound to an institution must be suitable to carry animals without causing injury or undue stress from extremes of temperature.

175

Receipt of Dogs at Institutions

10.34 The procedures and practices for the receipt of dogs

from pounds as well as facilities for their housing vary

significantly among institutions. Some institutions provide good facilities and the dogs receive appropriate care. Other

facilities, such as those at the University of New South Wales, are quite inadequate.

10.35 The Committee believes that clear guidelines must be

issued in each State and that they be enforced by government

inspectors making random visits to institutions.

10.36 All animals received by an institution from a pound must be given a veterinary inspection within 24 hours of receipt. All animals which are diseased, injured or do not meet experimental specifications must be destroyed by a veterinarian immediately and the bodies disposed of responsibly.

10.37 Dogs must be kept in facilities of an appropriate

care, nutrition and exercise. Any undue stress must be destroyed

standard and be given proper animals showing signs of

immediately.

Records

10.38 Both the pound and the institution must keep detailed

records of the animals transferred to institutions and allow inspectors to examine those records on request.

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The Supply of Cats from Pounds

1 0 .39 Councils in New South Wales and Victoria, at least, have

no clear legal basis on which they can take action to impound

cats, supply impounded cats to anyone or receive cats surrendered by owners.

10.40 Any action taken with respect to a cat by a council

pound could well be the subject of a legal challenge. The Dog Act covers only dogs. While councils have undoubted power under local government legislation to deal with stock it is doubtful if this includes stray cats.

10 . 41 There are substantial difficulties in establishing

ownership of domestic cats. There are no formal schemes for

registration of cat ownership. Tagging and identification of cats is at present purely voluntary.

10.42 It is difficult to guarantee that only genuine strays

are going to be supplied by pounds to research institutions. This is due to the fact that cats by nature are much more difficult to

keep under control.

10.43 There are also no standard holding periods that can be

enforced for impounded cats. Cats could be supplied or rehoused before an owner would necessarily begin searching for a missing cat.

10.44 Not all pounds are currently willing to handle cats.

Those which do so see it as a community service. The number of

cats being supplied by pounds to animal houses from the limited information available to the Committee is therefore relatively small.

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10.45 Cat breeding colonies are already in existence in

various universities. It would not be difficult to establish a stable source of supply to meet experimental needs .

10 . 46 The Committee RECOMMENDS that institutions either breed or purchase cats from an institution in which they are bred for experimental purposes and not acquire them from pounds or o t her non-institutional sources.

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II

CHAPTER 11

ANIMAL HOUSE STAFF

I ntroduction

11.1 In earlier chapters of this report, the Committee drew

attention to the increasing demand for higher quality animals for close definition of their genetic and health status in order to obtain reproducible data. This necessitates both good facilities and equipment and well trained staff. In this chapter the

Committee discusses staff of animal houses and training.

11.2 There are three basic levels of staff in animal houses:

professional staff, technicians and attendants. The professional staff are veterinarians who, in most cases, are the directors of the animal houses. From the responses to the Committee's

questionnaire, which covered the period 1980-84, in only nine animal houses of the 75 in non-Commonwealth institutions for which information was supplied, were veterinarians employed in this capacity. Few institutions had appointed a second

veterinarian. The Committee is aware, however, that the number of veterinarians employed in institutions has increased in recent years.

11.3 The animal technicians form the key element of animal

houses. In many institutions, a senior technician supervises the operations of the animal house. The technicians perform the more skilled jobs within the animal house and in many institutions carry out a range of routine experimental procedures.

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11.4 The routine jobs within animal houses are carried out by

animal attendants who may or may not have had training in animal care at colleges of technical and furthe r education.

11.5 In the larger institutions, there are usually s everal

animal breeding or holding units that function with some degree of administrative autonomy. Of the 98 separate units that had a staffing policy, 55 required formal qualifications or enrolment in appropriate courses as a condition of employment. Even in this group not all the i nstitutions required qualifications or course enrolment for all positions. Animal attendants were the group usually excluded from any formal requirement that they possess relevant qualifications or be enrolled in such a course.

11.6 The other 43 units did not have any formal course

requirement for animal house staff. However, most of these animal houses regarded such qualifications as desirable or encouraged staff to enrol in appropriate courses.

11.7 According to the responses to the questionnaire, about

15 per cent of technical staff and about 30 per cent of animal

attendants had no relevant qualifications and were not enrolled in courses to gain them in the period 1980-84. These figures are indicative rather than definitive because some institutions did not provide relevant information.

11.8 A survey conducted in Sydney during 1979-80 found that

about half the attendants employed in animal houses in research and teaching institutions had no qualifications and were not enrolled in any relevant courses.1

11.9 The Committee understands that this situation is

improving and there may be now a higher proportion of trained

staff in animal houses.

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11.10 The lack of a whole-hearted commitment to the employment of qualified animal house staff is a matter for concern. It is

acknowledged, however, that some of the unqualified staff

employed in animal houses are experienced and capable of a high standard of animal care. For many long-term employees, only on the job training was available during the early years of their

employment. There were no TAFE courses in which to enrol.

11.11 With on the job training, much depends on the ability

and knowledge of the supervisor. Do all supervisors have the

ability to train staff? Are they kept up-to-date with the latest techniques? Do they have time available to give attendants the breadth of knowledge they need or just to meet the requirements of particular duties? Some supervisors may give their staff full training but others may not. This will inevitably result in some

inadequately trained staff or, worse, the supply of animals not meeting the specifications of experimenters. Staff need the

t heoretical as well as the practical knowledge to do their jobs properly. To ensure that all staff have a broad theoretical base from which to develop their expertise and to give them the

opportunity to make animal care a satisfying career, institutions must adopt staffing policies which allow unqualified staff to enrol in animal care or animal technician courses. Anything less is both short-sighted and a disservice to the staff.

Status of Animal House Staff

11.12 In the past, animal houses were accorded low priority

for funding and were relegated to a low position within the

status hierarchy in institutions. Little attention was paid to working conditions, rates of pay, training of staff or even the standard of husbandry in animal houses. The smaller the

institution, the worse was the record.

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11.13 Concomitant with management's treatment of the staff of animal houses, many experimenters also accorded little respect to animal house staff or had no understanding of the importance of their work.

11.14 A representative of the Australian Animal Technicians Association described the attitudes prevailing at the time he began to work in this area:

11.15

I have been working with small animals for 25 years, and when I first started the person

working in the animal house was not considered at all. He was just there with a broom or

shovel. He just fed the animals and cleaned

the animal house. The researcher would come into the animal house and carry out the

experiment, not even speaking to the

person there.

Another witness described the attitude to staff in an animal house attached to a hospital in the following terms:

11.16

I am employed as a laboratory attendant. The authorities prefer people to do the course. You are not paid any more and the two wardsmen who look after our animal house do not want to go any further. Of course after years of being there, they are paid on the equivalent scale to me. They say: 'Why should we go to college

or whatever because we are not going to get

paid any more.3

While attitudes revealed in the institution discussed above are not necessarily typical they point to difficulties in staffing and training of animal house staff particularly in

smaller institutions.

11.17 Mr I. Harris, Director of the University of Queensland

Central Animal House, expressed the following view:

182

11.18

The problem now, I think, is nowhere near as

acute as it might have been in the past ...

Most large institutions around Australia are now employing trained people and actively

encouraging people to be trained. The problem, where it exists, tends to be in smaller

places.4 .

During inspections at two universities, the Committee encountered a disregard for

Other anecdotal animal house rules by some

experimenters. sources drew attention information from a range of

to either taken by the unthinking or even the

a minority of experimenters cavalier attitude being towards animal houses and their staff. The AATA submitted:

11.19 oversee larger problem. many of

Animal technicians who remain in the field for any length of time develop a real concern for the welfare of the animals in their

Conflict with the animal experimentation

practices of some scientists sometimes occurs in experimental animal houses. Given the lowly status of the animal technicians, their views are likely to be ignored in such a situation.

In institutions where technicians do not have access to an animal house veterinarian or

animal welfare officer, the resolution of such conflicts can be very difficult. The A.A.T.A. believes that all institutions working with experimental animals should have

an animal house veterinarian or animal welfare officer to whom technicians can take their

problems in this regard.s

With the trend towards appointing more veterinarians to houses, particularly be a diminution of

in the

this

the operations of animal institutions, there should In addition, if the number the smaller animal houses

of animal houses contracts, will disappear. All the

evidence points to the worst problems occurring in those areas. However, even professional staff sometimes have difficulties with some experimenters. It procedures be adopted

is essential, to enable

therefore, that difficulties written between

experimenters and animal house staff to be resolved. Such

183

difficulties should be brought to the attention of the chairman of the ethics committee and it is his or her responsibility to

either .rectify the problem or raise it with senior management. Animal house staff must be able to draw attention to improper, inhumane or even illegal practices without any fear of

retribution of any kind against them for having raised the

matter.

11.20 A number of other difficulties concerning the career

options available to animal technicians were raised by the AATA:

The career structure and promotion

opportunities for animal technicians vary widely from institution to institution. In

many cases, they lag well behind the

opportunities and level of financial reward for laboratory technicians with comparable levels of training. In many institutions it is not recognised as a skilled occupation at all. The fact that it is a small area of employment

within some institutions worsens the problem.

The result is that there tends to be a fast

turnover in animal technician staff, and the more capable people do not tend to remain in

the field very long as they are attracted ·to

better opportunities in other areas. The A.A.T.A. believes this has a detrimental effect on the quality of experimental animal care, which could be improved if the career

structure and promotional opportunities

available to animal technicians were

comparable to that in other fields with

similar training requirements, e.g. laboratory technicians.

Also, in

course is providing technical obstacle would be

training States.6

some States, the relevant T.A.F.E. not recognized by major employers as eligibility for promotion to

officer grades. This creates a major to promotion opportunities. This overcome if a suitable national core curriculum was adopted in all

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11. 21 The accreditation of research institutions which is an

integr al part of the New South Wales Animal Research Act is

l ikely to influence institutional policy on these issues within that State as assessment of the quality and qualifications of the s taff is part of the process of accreditation.

Training in Animal Care

11.22 Courses in animal care are currently offered at TAFE

institut i o ns in the Australian Capital Territory and every State except Tasmania.

11.23 The publication of a national core curriculum by the

Curriculum Projects Steering Group of the Australian Conference of TAFE

curr icula Directors marks a significant

have been agreed upon for both

step forward. Core

the one year Animal

Attendants Course and the four year Animal Technicians Course.

11.24 Work is proceeding in several States to bring animal

care c ourses into line with the core curriculum recommendations . The AATA and ASLAS agreed that adoption by all States and

Territorie s of a common core curriculum would enable greater

mobility of staff between States and open up greater options with resp e ct to career paths for qualified staff.?

11.25 The Committee encourages the close involvement of

e mp loyer and industry groups in the development and

imple mentation of new animal care courses . Given the relative s hortage of expertise in the laboratory animal area such

inv olvement will be absolutely necessary if standards of teaching and the relevance of courses to students is to be maximised .

Priority should be given to the development of ongoing external review and assessment of animal care courses where this does not already exist.

185

11 . 26 Providing the resources to implement the curricula

effectively is likely to be difficult not only because of direct constraints on finance and equipment but also because of the

relatively small size of the industry and hence the lack of

appropriately experienced and qualified teachers. Constraints have led to unqualified people being called upon to teach courses in this field. 8

11.27 One particular development that was drawn to the

attention of the Committee has the potential to undermine the effectiveness of even current institutional commitments to upgrading staff qualifications. Dr J. Smith appearing on behalf of the Australian National University pointed out:

while a lot of the TAFE courses are .run

after normal working hours, there are some

that cannot be run after normal working hours for various reasons and people have to be

given time off from work to attend tech. With the gradual tightening of the economic

situation over the last few years, most

animal houses, I think, have been told to

increase their efficiency and most have. Part of this is reducing staff because staff is the greatest expense in any animal establishment. A lot of them are reaching the stage where it

will be very difficult to give any staff any

time off from normal working hours and still

maintain their standards of animal care.9

11.28 Should this situation occur more widely, the impact on

animal welfare both in the long and short term is likely to be

substantial and undo much of the progress achieved by the

upgrading of facilities that has already occurred. As the

Committee argued in Chapter 10, on both welfare and scientific grounds, if animals are to be used in experimentation, facilities and staffing must be of a consistently high standard. This cannot be achieved if research institutions do not have the resources to enable appropriate staff training to be undertaken.

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1 1.29 The Committee RECOMMENDS that all institutions with

a nimal houses require unqualified staff to undertake technical

t raining courses in animal care at colleges of technical and

£ urther education.

Professional Staff

11.30 Only the institutions which have a large breeding unit

a s part of their animal house operations are generally in a

p osition to employ a professional director or manager. Discussing

t he management of their animal house Professor Cooper explained

t he difficulties of small to medium sized units in employing full

t ime veterinarians:

11.31

It is again a question of our small size.

Ideally, we would like to have somebody with a veterinary qualification in that sort of

position, but it is quite clear that the job

is not big enough for that. I have alluded in

this paper to the fact that we are negotiating with another institution to pay it a retainer and have it act as our veterinary consultant. I may say that we have done very well up until

now in getting it free from a number of

institutions. So since we cannot appoint at that kind of level, we have appointed at

Mr Smallshaw's level, which is at a senior

technical level ... It does mean that he has

to establish liaison with people off campus to obtain the kind of expertise which we do not

have.10

A similar issue was raised by Dr Kuchel. Asked whether

it was necessary to employ qualified veterinarians he replied:

with the increased complexity of running research facilities and breeding facilities you need someone with day-to-day

administrative and physical control to have veterinary qualifications, so that all of the implications of what is happening at that

facility, as far as the researcher is

concerned and as far as the breeding program

187

11.32

is concerned, are picked up as soon as

possible and dealt with appropriately. The field of laboratory animal science now is

becoming, rather than just an amalgam of

general clinical principles, a discipline in its own right that requires, for it to be done

properly, the sort of basic sciences

background that the degree in veterinary

science gives you.11

The Committee acknowledges the difficulty of employing veterinarians in institutions with relatively small animal houses. The best arrangement is to have a veterinarian within the institution or one located nearby to be on call in case of

problems. The long-term solution is, however, for the contraction in the number of breeding units and a move towards the

centralisation animals will

of breeding be bred

professional staff.

within a region. In this way, most

in purpose-built with

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CHAPTER 12

INFORMATION AND TRAINING

Introduction

12.1 With State Governments and the Committee opting for

enforced self-regulation as the system of administration to control animal experimentation, much responsibility falls on experimenters to fulfil the expectations of the community to

maintain a high level of care and welfare in their use of

animals. High standards of care and welfare qepend on the

attitudes and training of and information available to

experimenters and animal technicians and attendants. The

Committee has already discussed attitudes to the use of animals in experiments in this report. It now examines the role of

information and training of experimenters. The training of animal technicians and attendants was covered in chapter 11.

Experimentation Standards

12.2 Representatives of institutions and experimenters

generally adopted the attitude during the inquiry of the

Committee that experimenters in Australia maintained high

standards in the conduct of experiments on animals. Few witnesses questioned the effectiveness of the training and the level of skills of experimenters. An example of this attitude is contained in a special submission made by the Deputy Vice-Chancellor of the

University of New South Wales concerning a report which the

University had commissioned on animal facilities within the University. The view was expressed in the submission:

189

Central to this philosophical approach was the creation of an Animal Resources Unit as an

academic unit

to provide professional services to the

activities of animal production, and

experimentation and public accountability;

to co-ordinate animal production to support teaching and research activities;

to provide resources

animal-based research institution in the most

manner practicable.

required in

within the

cost-effective

According to the report this Unit must be

identified as an academic centre and demands on the levels of responsibility and time must be commensurate with other academic

appointments.

What this means is that the staff employed in the Unit would spend about one-third of their time on research and would have access to

study leave provisions and other benefits

accruing to academic staff. In the words of an academic adviser to me on the report

'I believe that the creation of the

ARU as an academic unit is the dream of many veterinarians involved in animal house management. I suspect such recommendations reveal more about the aspirations and ambitions of the writers than the

needs of the researchers.'

I endorse this view. The rationale for the

creation of an academic unit, stated or

implied, is that researchers are hopelessly ill-equipped to conduct research on animals. This is patently not true. Researchers at the University of New South Wales will have

trained with research groups either in

Australia or overseas in which a core of

procedures, techniques and animal models are well developed and at the forefront of

international practice. The best expertise in the world is available in the University and in Australia and it is simple-minded to assume that our researchers who use animals approach their experimental tasks in a state of

ignorance of, and experience in, the latest

techniques of animal experimentation.l

190

12.3 The Committee found it ironic when an advertisement

appeared in 'The Sydney Morning Herald' of 24 June 1989 for

applications for the position of Director of Animal Care at the University of New South Wales. Not only had the University now accepted the need for academic standing for the position, which was stated in the advertisement, but it also had upgraded it to

professorial level.

12.4 Further on, the University, commenting on the proposal

to establish an Animal Resources Unit as an academic unit,

stated:

The ABHU (the central breeding unit> is in the business of ensuring that animal researchers are provided with experimental animals of the highest quality at least cost and it. is

expected that those who are in charge of

production be doing just that and not carrying out personal research into animal

experimentation techniques that may or may not be useful. Nor does the University with its

advanced information retrieval systems and well-stocked library in the biomedical

sciences see a need in present financial

circustances, to provide an information

service to researchers who, if the are of the

standard we expect in the University, will

already be quite aware of, and use, the latest humane and efficient techniques.2

12.5 Despite these claims, there are serious criticisms

overseas of experimenters' skills and there is enough evidence in Australia to question seriously the claims of many witnesses.

12.6 The Canadian Council of Animal Care prepared a syllabus

in 1983 for training of students in laboratory animal science. In its introduction, it is stated:

A deficiency frequently observed by numerous Canadian Council on Animal Care

assessment panels visiting the many

institutions in Canada conducting animal based research, teaching and testing, is the number

191

of investigators who appear to lack an

understanding of the basic principles of

laboratory animal science. This is exhibited in many ways ranging from inappropriate animal models and poor experimental design, to

inadequate handling methods, poor surgery techniques, which indicate an apparent lack of appreciation of basic surgical concepts, and a failure to recognize and make use of resources available to them.

This deficiency is probably at least partly due to inadequacies in the undergraduate and graduate programs in science and, in addition, to inadequate tutoring or preceptorship,

particularly at the graduate level. All too often panel& witnessed the propagation by

investigators and teachers of poor or

antiquated techniques of animal care and use.3

12.7 Dr M. Rose drew upon a Handbook published by the

Foundation for Biomedical Research in America in her evidence to the Committee. She quoted from the Handbook as followed:

Environmental and biological factors may

profoundly influence data from animal

experiments by exerting a subtle influence on animal research and testing. Scientists have begun to appreciate that influence only

recently.4

Dr Rose went on to refer to a report by the Council

International Organisations in Medical Sciences affiliated with the World Health Organization. She Commitee:

In the covering letter to this report, the

committee asked CRIMS to convey to WHO its

view that for the benefit of health programs everywhere, this activity, the use of animals in research and teaching and testing, should be enhanced and that particular attention

should be given to some matters. Its first

statement related to education and training. It said that in addition to the development of specific guidelines there was a need for more education and training, both of investigators using animals and of personnel responsible for their handling and care.S

192

which told

for is

the

12.8 At Monash University in 1981, a review of services of

the Central Animal House was done. Two-thirds of the respondents stated that further knowledge about one or more topics contained in a list of 13 topics concerning the use of laboratory animals

would be advantageous to their work. In answer to another

question, 'In respect of the topics stated above, do you believe that there should be an ongoing programme to keep post-graduates abreast of new developments', 47 of 67 respondents replied

'yes' .6 There are obviously Australian experimenters who believe that additional information on laboratory animal science would be advantageous to their work.

12.9 At present, most experimenters in Australia learn

experimental techniques and practices on the job from the senior experimenters who are their supervisors. Not all senior

experimenters have correct techniques or have kept abreast with developments in laboratory animal science. In these cases, bad habits and techniques are passed on to the junior experimenters, who may or may not have such techniques or practices corrected in

subsequent appointments. Bad habits are therefore perpetuated. Many experimenters do not know that their experimental techniques are deficient or are out-of-date and resent suggestions that they are.

12.10 The Committee has already referred to the findings of

the Canadian Council on Animal Care on this method of training . In the United Kingdom, a Working Party reported in 1983 on

courses for experimenters. It stated:

The system of individual coaching has worked well over a long period and will continue to

serve in many circumstances. However, it can be very time-consuming for the senior licensee carrying out the individual coaching, and the tutor is likely to concentrate on the task in

hand to the detriment of background

information and perspective. It also seems probable that any new legislation concerning animal experiments may require a wider

193

12.11 changes Although

understanding of the principles of laboratory animal husbandry and related matters. From such considerations it became apparent that the principle of formal training courses would be generally welcomed.7

Technology can change quickly. New techniques, in experimental design are being developed all drugs or the time.

it is desirable to embrace these changes, it is

difficult to get information about them. There is also an

inherent resistance to change. If something has worked well for a long time, why change to something new, even if the new product or technique has been proven to be better? There is a reluctance to try an alternative for fear that it will not work as well.

12.12 It must be emphasised that new products and techniques

may not only improve animal welfare but may also result in more

reliable data. They may also result in lower costs. For example, a new technique may result in fewer animals being used and hence

less money spent on the purchase of animals. Animals are often expensive to breed and care for and savings forgone because of resistance to change will lead to fewer funds available for

research and teaching.

12.13 Some institutions have held short courses on laboratory animal science for experimenters. The Committee was given

information about 'training courses for the research worker' at the University of Melbourne:

At the commencement of each academic year the University of Melbourne runs a short training course for post graduate students and

laboratory assistants embarking on Bio-medical research ... Emphasis in the training program is placed on the law, the relevant Code of

Practice and investigator responsibility. Demonstrations cover the proper way to pick up, hold, restrain, administer substances, collect samples and generally care for each of the common laboratory animal species.

Investigators are advised where they can go for help and are provided with useful

reference material.7

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1 2.14 At hearings in March 1987, the Committee was told by

r epresentatives of the Department of Physiology and Pharmacology o f the University of Queensland that animal care workshops

l asting one day were being held for honours year students. An

outline of a longer course of one or two weeks duration for

u ndergraduate students had been prepared but had not yet been approved. The Head of the Department, Dr A. Blackshaw, commented t hat he would like the course extended to post-graduate

students.8

12.15 Little can be taught in a one day course. It is doubtful

that a week is long enough to cover in enough depth the variety

of ethical issues, legal and procedural requirements, scientific techniques and animal care and husbandry information that an experimenter needs to know to begin a career involving

experiments on animals. Any course or workshop is, however, a step in the right direction and the conduct of such courses is

evidence of an awareness within an institution of the need to

equip young experimenters with a positive ethical attitude

towards experiments on animals and information on scientific techniques and animal care.

12.16 There is no course available in Australia in laboratory animal science. However, the University of Sydney in its

submission told the Committee that it was planning to introduce a course in laboratory animal science in the Faculty of Veterinary Science. In referring to this proposal in a public hearing,

Professor Titchen of the University of Sydney said:

These developments would include the

development of specialist pathological

facilities for monitoring the standards and the care of the common laboratory animals, the development of specialist capacities in the control of pain and the dissemination of

knowledge on the techniques of anaesthesia and analgesia in animals. They would include

specialist instruction in animal handling. They would also include some level of

195

instruction and, perhaps, the performance of experimental surgical procedures. This is an ambitious and expensive undertaking to

complete. We see no other way than entering

into such an educational program for our

undergraduates in science, veterinary science, and the biological sciences, and for

postgraduate instruction and to contribute to improvements in animal welfare.9

12.17 The University's proposal for a course in laboratory

animal science and the preparedness of the University to outlay considerable funds to establish the course is an acknowledgement of the need for such a course in Australia. The University has

also sought additional funding from the Commonwealth Government under its key centre scheme.

12.18 The Committee considered the proposal and RECOMMENDS that extra funds be made available by the Commonwealth Government to enable the University of Sydney to establish a course in

laboratory animal science.

12.19 Earlier in the inquiry the University of Queensland

proposed the establishment of a course on animal welfare and

behaviour. In a written proposal, the University said:

Current public interest in animal welfare

issues is high. Livestock industries are in

the process of preparing codes of practice for domestic animals. These efforts have

highlighted many aspects which need proper scientific investigation

intensive housing, reproductive behaviour, etc.). In addition, topics such as the role

and use of companion animals, the use of

animals for entertainment and research, and the behaviour and management of wild animals are all due for consideration. Scientific

investigations into most of these topics are few, fragmented and they lack focus

196

1 2.20

A Chair in Animal Behaviour and Welfare would act as a focal point for research and

expertise in the above areas. Whilst requiring Governmental support for establishment, there is every indication that it would attract

support from groups and industries interested in, or concerned about, animal welfare. The

Senate Select Committee on Animal Welfare

could envisage such a Chair as a positive

contribution towards the welfare of all

animals with which humans are associated. In addition, this Chair would be an invaluable aid ... to the public in providing factual and

impartial evidence on many contentious

issues.10

There are many areas of animal welfare that need further r esearch in order to refine current procedures and practices or

t o find alternative ways of solving husbandry and other problems.

Animal behaviour is a component of animal studies, albeit an

i mportant component. However, the focus of the course should be

o n animal welfare generally rather than on animal behaviour. With

that qualification, the Committee supports the proposal. The Committee RECOMMENDS that funds be made available to the

University of Queensland to establish a chair in animal welfare and behaviour.

Australian Council for the Care of Animals in Research and

Teaching

12.21 For some years there has been a move to establish an

Australian Council for the Care of Animals in Research and

Teaching based on the model of the Canadian Council on Animal Care. This has been in response to the perceived need to improve the flow of information to experimenters and to provide a resource centre for experimenters who need particular information which may not be readily available from institutional libraries

and other normal sources.

197

12.22 In a submission to the Committee, ACCART stated that it

was established as an independent body:

1 2 . 23

to provide a national forum for effective communication between persons with concerns for the care and use of animals in research

and tertiary teaching, and to provide

information and advice on optimal standards for their care and use.ll

Although ACCART was modelled to some extent on t he

Canadian Council on Animal Care, after lengthy deliberations among the proponents and other interested organisations, it was decided to exclude accreditation, a major function of the Canadian Council, from the role of ACCART. It was decided that accreditation should remain the responsibility of State Governments.

12 . 24 As at August 1988, 16 organisati.ons had joined ACCART

and another had been granted observer status at its own request . Although both ANZFAS and RSPCA Australia had been invited t o join, neither has yet accepted the invitation. ACCART so far

lacks input from animal welfare organisations. The Committee believes that animal welfare organisations have a contribution to make to ACCART as ACCART will be preparing and publishing

information on a wide range of technical and other matters

relating to the use of animals in experiments. The Committee has often espoused the·need for discussion among the parties to the animal welfare debate. ACCART will provide an ongoing forum for discussion on issues relating to animal experimentation and it is an opportunity for animal welfare organisations to participate in

the work of the Council bringing a different perspective from the other members. The exchange of ideas in a neutral forum will help to find a middle ground on issues where there is a difference of opinion and so enable enduring improvements to animal welfare to be made.

198

1 2 . 25 It was suggested at one stage that ACCART be made an

a dvisory committee to a Commonwealth Minister. The strength of ACCART is its independence from government. It can draw on a wide r ange of expertise in Australia to provide information and other r esources. It can and should give technical advice to government

a nd government authorities, as well as to institutions and

i ndividual scientists. The fact that it is not beholden to any

g overnment means that it will be accepted more readily by the

s cientific community.

1 2.26 ACCART will also provide a forum for Australian and

overseas experts to focus attention on a range of animal

e xperimentation matters. Through seminars and conferences, run e ither by ACCART itself or in association with specialist bodies, s uch as ASLAS, complicated or controversial issues can be

d iscussed to enable experimenters to keep abreast of developments i n these fields.

12.27 Although ACCART's commencement was delayed, despite the e fforts of the AVCC and the CSIRO, which were two of the three

s ponsors of the organisation, it has quickly made its mark with t he publication of a newsletter, which has received wide

acclamation overseas. Several monographs are also in production. ACCART is beginning to fulfil its important role of disseminating

information to the scientific community, filling the void which has existed for a long time.

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CHAPTER 13

ANIMAL WELFARE ADMINISTRATION IN AUSTRALIA

Introduction

13.1 The Committee believes it is timely to consider the

administration of animal welfare in Australia in this report. Administration of animal experimentation is intertwined with the administration of general animal welfare matters in some States so that consideration of one and not the other would be

impractical.

13.2 The administration of animal welfare falls into two

areas - the legislative, regulatory and administrative framework on the one hand and operational matters on the other. In this

report the Committee will address the former but not the latter. Operational matters, such as the day-to-day administration of prevention of cruelty to animals legislation and the funding of animal welfare organisations with statutory responsibilities, will be examined and reported on later in the Committee's

inquiry.

Commonwealth/State Responsibilities

13.3 Under the Commonwealth Constitution, animal welfare is mainly a State responsibility. The Commonwealth Government has direct responsibility for quarantine, customs, exports and

imports. It also has other responsibilities which arise

indirectly from its activities in the field of foreign affairs. Under the latter, for example, the Commonwealth has to deal with

201

animal welfare issues on a government to government basis and act as a focal point for other overseas interests in animal welfar e in Australia. In recent years, overseas concern about the killing

of kangaroos and the helicopter shooting of horses and buffalo , among other issues, has generated considerable work for the

Commonwealth Government . It has had to respond to numerous

letters from overseas and to defend Australian policies a nd

practices in a number of overseas forums, particularly in Europe and the U.S.A .

13.4 Nevertheless, most animal welfare issues remain State

responsibilities. In each State and Territory there is

legislation for the prevention of cruelty to animals.

13.5 The legislation in New South Wales, Victoria and South

Australia was significantly revised between 1985 and 1986 to take account of changing community attitudes to the use and care of animals . In New South Wales the Government enacted separate

l egislation (the Animal Research Act 1985> to control the use of animals in research and teaching.

13.6 In Queensland, the Government recently advertised a

review of the Animals Protection Act. A wide review of the

Prevention of Cruelty to Animals Ordinance 1959 has been done in the A. C.T . The period for public comment on the report of the

review has closed and new legislation may be prepared later in the year . A little work has been done on revising the Western

Australian Prevention of Cruelty to Animals Act 1920-1976. As far as the Committee can find out, no work has been done to update

the Tasmanian Cruelty to Animals Prevention Act 1925 or the

Prevention of Cruelty to Animals Act in the Northern Territory.

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13.7 Under the revised legislation, animal welfare advisory

councils have been appointed in New South Wales, Victoria and South Australia. In New South Wales, in addition to the AWAC, an Animal Research Review Panel has been appointed under the

Animal Research Act 1985.

1 3 .8 These three States have adopted a new participative

approach to animal welfare administration by including on the advisory councils representatives of a range of animal welfare, c ommunity, user and government interests.

13 . 9 There are two main Commonwealth/State organisations

which have been involved in

Sub-Committee on Animal Welfare Council and the Joint

animal welfare issues the

of the Australian Agricultural Animal Welfare Council .

SCAW's main function has been to prepare codes of practice for farm animal husbandry and transportation. It was also involved in the preparation of the 1985 edition of the Code of Practice for the Care and Use of Animals for Experimental Purposes and in the current revision of the Code of Practice.

13 . 10 JAWC comprises the Chairmen of State AWACs and the

officers responsible for the administration of animal welfare in the States, Territories and the Commonwealth. At present,

membership has been limited to those States which have .appointed AWACs, but observers from Western Australia, the A. C.T., the

Northern Territory and the Commonwealth have attended meetings.

13.11 The main purpose of JAWC is to provide a forum for

State, Territory and Commonwealth animal welfare administrators and representatives of AWACS to discuss issues of mutual concern with a view to the States and Territories adopting, where

possible, a common approach to them.

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13.12 Because only three States have appointed AWACs, JAWC is still in its formative stage. Nevertheless, it has successfully brought together representatives from States and Territories to consider various animal welfare problems.

13.13 A number of organisations in their original submissions proposed a national structure for animal welfare administration in Australia . These

Government playing a proposals centred on key role in developing the Commonwealth

and co-ordinating

animal welfare policy. These proposals are outlined below.

13.14 In its original submission, ANZFAS proposed that the

Commonwealth Government assume responsibility for animal welfare in Australia and establish a statutory authority to administer it nationally. ANZFAS acknowledged that there was no constitutional head of power under which the Commonwealth could make laws

concerning animals, but stated that:

13.15

reliance upon a combination of existing heads of power capable of application to

animals and their welfare would suffice to

create a statutory authority equipped to play a significant role in animal welfare in

Australia. Perhaps, such existing heads of

power could be amplified by co-operation

amongst the States.1

ANZFAS recommended the assumption of responsiblity by

the Commonwealth Government for animal welfare in order to

achieve a greater uniformity in the regulation of animal welfare among the States and Territories. As mentioned above, there are significant differences of approach among the States, although the establishment of JAWC is an acknowledgement of this problem and a realisation that a more uniform approach is desirable.

13.16 In its submission to the Committee in 1984, RSPCA

Australia stated its belief that:

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13.17

to achieve a satisfactorily co-ordinated overview of animal welfare in this country, the Government, through the Minister of

Primary Industry should be the controlling influence.2

RSPCA went on to recommend that it become a consultative body to the Minister, situated between the Minister and a

proposed national animal welfare advisory committee in the flow chart in the submission . 3 The State Governments would be

represented through the Australian Agricultural Council. Both the Council and the advisory committee would be served by the then Australian Bureau of Animal Health within the Depart ment of Primary Industry.

13.18 At the time of the RSPCA's submission , there was a

strong body within ABAH supportive of animal welfare. Since then, ABAH has undergone several metamorphoses and the animal welfare

function of ABAH has disappeared. Such matters have been dealt with by one division or another as necessary, b u t no division has displayed any interest in handling animal welfare on a long-term basis.

13.19 The Australian Veterinary Association (AVA> also

proposed the establishment of a national animal welfare advisory council in its submission to the Committee in 1984. In this

proposal, the role of the advisory counci J. would include the

provision of a forum for discussing animal welfare issues; the identification and promotion of research into animal welfare matters and the supervision of the allocation of funds for that research and advice to governments on animal welfare and the need

for legislation.

13.20 It should be remembered that these recommendations for the establishment of a national animal welfare advisory committee were made four or five years ago before three of the State

had revised animal welfare legislation and Governments established or expanded animal welfare units within their

administrations.

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13.21 Until 1985, the States had kept a low profile in animal

welfare matters. On the other hand, ABAH was playing a leading role in promoting animal welfare. It was natural, therefore, for organisations that sought change in animal welfare policies and practices to focus attention on ABAH and to formulate a structure

for the administration of animal welfare with ABAH playing a central role.

13.22 With the demise of ABAH and the moves by State and

Territory Governments to take control of animal welfare, the situation is now very different to that which prevailed in 1984 .

13.23 In October 1988, following representations from RSPCA Australia, the Minister for Primary Industries and Energy

proposed the appointment of a national animal welfare

consultative council. The proposal was along the lines of the

RSPCA's recommendations although it did not encompass the wider framework as contained in RSPCA's submission to the Committee. It also did not address the potential overlap of functions between the consultative council and SCAW.

13.24 There are major problems with the establishment of a

national AWAC, given that constitutional responsibility for animal welfare rests largely with the States.

13.25 The problems can be most clearly identified by

considering the lines of authority for implementing advice given by an advisory body. If the person to whom the advice is given

has no authority to take action on that advice, it is

questionable whether there is justification for that person having a body to advise him.

13.26 A national AWAC would obviously advise a Commonwealth minister on matters for which that minister had responsibility and authority. These are, as mentioned earlier, few in number.

206

13.27 It is incongruous for State Government representatives o n a national AWAC to advise a Commonwealth minister on any

matter for which responsibility and authority is vested in State and Territory ministers. For that advice to be implemented, the Commonwealth minister would have to approach the State and

Territory ministers asking them to take action. If the State

representatives on a national AWAC had assented to particular advice being given to the Commonwealth minister, they would, presumably, in most cases have already taken up the matter with their State AWACs and cleared it with their ministers beforehand.

It would therefore be unnecessary for a Commonwealth minister to a sk the State ministers to take action on a particular proposal because the State ministers would already have agreed to it.

13.28 With the States and Territories progressively moving to take up animal welfare responsibilities in an active way, there i s no prospect of the State Governments voluntarily handing over t heir responsibilities to the Commonwealth Government. The Commonwealth Government has also shown no inclination to use indirect constitutional mechanisms, if in fact they exist, to usurp those responsiblities. Without a political willingness to

transfer responsibility for animal welfare from the States and Territories to the Commonwealth, there is no point in pursuing an approach which is fraught with political and administrative difficulties.

13.29 Even if the Commonwealth were to take on responsibility for animal welfare, it would either depend on the States for much of the administration or it would have to assemble a large

bureaucracy to oversee the administration of animal welfare. In the current economic climate of restraint on government spending, the latter is neither desirable nor practicable. If the

commonwealth were to devolve the administration of some of its animal welfare programmes to the States, the question might be asked as to why the States gave up the responsibility in the

first place.

207

13.30 However, even if devolution occurred, there is no

assurance that uniformity in approach by the participating States would continue. During its examination of the live sheep expor t industry, the Committee found significantly different approaches being taken among the State authorities acting on behalf of the Commonwealth Government. There was also a lack of will on the

part of the Commonwealth authority to maintain a common approach or uphold uniform standards.

13.31 Wi thout national r esponsibility for animal welfare i n

the hands of the Commonwealth Government, there is little point i n having a national AWAC responsible to a Commonwealth minister.

The minister would have no responsibility to take action on the advice of the AWAC, except in those matters where t he

Commonwealth has a constitutional responsibil1ty, because responsibility is vested in the States.

13 . 32 Although the Committee does not see the point in t h e

establishment of a national AWAC, it does acknowledge the need for of

the Commonwealth to have a source of advice on its own areas responsibility and on those matters which arise in

Commonwealth-State forums or are raised in international forums .

13.33 CSIRO

In a supplementary submission dated November 1988, t h e recommended to the Committee that it support t he

establishment of a Commonwealth AWAC, the main function of which would be to provide advice to the Commonwealth Government. The AWAC would comprise representatives of several Commonwealth

Government departments and authorities as well as a number o f national organisations, such as ANZFAS, RSPCA Australia, the AVA, the NFF and so on. It also argued that it would be preferable for the AWAC to be responsible to a neutral minister who would not be placed in a position of a potential conflict of interest.

208

13.34 For a Commonwealth AWAC to be effective, the Minister to which it provides advice has to have responsibility and authority for animal welfare matters across the spectrum of Commonwealth interests. At present, responsibility is spread over a number of ministers. Therefore Cabinet would need to devolve responsibility

for animal welfare to one minister.

Federal System

13.35 Having come to the conclusion that a system of animal

welfare administration based on Commonwealth primacy is not practicable either politically or operationally, the Committee turned to a federal system.

13.36 An important principle has already been included in

animal welfare arrangements in New South Wales, Victoria and South Australia - the participation of animal welfare, community and user representatives in the administrative and policy

process. This is necessary if there is to be future co-operation and development of effective animal welfare policies which have broad community support . It cannot be emphasised enough the role which these representatives play. Without this community

representation, polarisation of the interests in the debate will lead to more bitter confrontations which can only disrupt the progressive development of policies and programmes to enhance animal welfare in Australia.

13.37 Another essential element in an effective administrative system is extensive consultation and co-operation with other interested organisations which are not represented on the AWAC. By developing policies and practices in conjunction with

interested bodies, there will be a greater likelihood of support and co-operation by the organisations and their members.

13 . 38 Over the period that they have been operational, the

three State AWACs have already shown their value.

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13.39 The Committee believes that each State and Territory

should establish an AWAC along the lines of the three already i n existence. Each should be responsible to a neutral minister and served by an animal welfare secretariat in the minister's

department. For example, in New South Wales, the Minister for Local Government has responsibility for animal welfare matters while in South Australia, that responsibility is vested in the Minister for Lands.

13.40 Legislation in States and Territories other than New

South Wales, Victoria and South Australia needs to be updated to cover the revised administrative arrangements and to provide for regulations which might also include codes of practice.

13.41 Although each State and Territory has responsibility for most animal welfare matters within its borders, there is a need for the States and Territories to achieve as much uniformity as possible in legislative and regulatory requirements and in animal practices. A similar approach should be taken even if identical requirements cannot be achieved because of different

environmental and other factors prevailing among the States and Territories.

13.42 As responsibility for animal welfare is vested

ultimately in ministers responsible for animal welfare in the States and Territories, questions of uniformity of approach should be considered by them. In many areas of Commonwealth/State relations, there are ministerial councils comprising

Commonwealth, State and Territory ministers. It would be

appropriate for a council of animal welfare ministers to be

established when most States and Territories have appointed AWACs and have updated animal protection legislation.

13.43 If a ministerial council for animal welfare were formed, JAWC would become the standing committee to function along

similar lines of standing committees associated with other

ministerial councils.

210

13.44 Until such time as a ministerial council for animal

welfare is formed, JAWC should continue to meet to discuss animal welfare matters at AWAC and officer level. Rather than meet

annually as it has done, it should meet quarterly to enable more timely discussion of issues as they arise. Throughout the

inquiry, the need for uniformity has continually been advocated. At least discussions within JAWC will increase the opportunity of similar or uniform approaches being taken among the States and Territories. Each State and Territory Government will still

retain the right to implement policies and enact legislation

which it thinks will best enhance animal welfare within its

jurisdiction . However, any Government will at least have the

benefit of broad advice, not only from its own advisory council but from experience obtained in other States and Territories, before it makes its decisions.

13.45 It is also hoped that JAWC will provide a continuing

service distributing information about animal welfare matters among the States.

13.46 The Committee RECOMMENDS that all States and Territories upgrade animal welfare legislation, and establish animal welfare advisory councils and departmental animal welfare units as has been done in New South Wales, Victoria and South Australia.

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CHAPTER 14

CURRENT REGULATORY SYSTEM

I n troduction

14. 1 Significant changes in the regulation of animal

experimentation in Australia have occurred within the last ten y e ars. These changes have been made both by the scientific and educational community and by government. The former has developed a code of practice, set up ethics committees and has generally

t aken steps to promote a more ethical approach to animal

experimentation and animal welfare. The latter has begun to

update legislation and improve the regulation of animal

e xperimentation.

14. 2 In this chapter, the evolution and the current state of

t he regulatory system are described.

Evolution of the Code of Practice

14.3 Until recently, government had taken a mainly

non-interventionist role in the control of animal

experimentation. It was left to the scientific and educational community to regulate itself. In 1965 the NHMRC began work on a code of practice which was issued in 1969. Its stated aim was to define a code of conduct which would encourage humane treatment of experimental animals. The code was designed to promote

awareness of animal ethics and welfare but not to provide

mechanisms for accountability.

213

14.4 In 1979, the NHMRC and CSIRO jointly revised the Code of

Practice. An important inclusion in this edition was the

requirement for institutions to establish ethics committees.

14.5 In the 1982 revision of the Code of Practice, provisions

were included to make ethics committees more accountable to the wider community. The ethics committee had to include a person not employed by the institution to represent community interests and the committee had to maintain a register of all approved

research.

14.6 April

The next edition of the Code of Practice was issued in 1985. This edition was endorsed by the Australian

Agricultural Council as well as by the NHMRC and CSIRO.

14.7 The fifth edition of the Code of Practice is in draft

form. It has been endorsed by the NHMRC but is awaiting the

endorsement of its other sponsor bodies and State Governments. It both tightens up and clarifies some of the provisions of the

previous edition. It also sets out more clearly the

responsibilities of institutions, ethics committees and

experimenters in relation to animal experimentation.

14.8 The NHMRC, as now do many other funding bodies, requires applicants for funds and their institutions to comply with the provisions of the Code of Practice. Until recently, as mentioned later in the report, the NHMRC did nothing to ensure compliance with the Code of Practice by experimenters and institutions.

Legislation

14.9 Except for New South Wales, legislative provisions

dealing with animal experimentation are contained in State and Territory prevention of cruelty to animals legislation. Until 1985 and 1986, such . provisions were cursory at best, with

Tasmania merely exempting animal experimentation from the cruelty

214

provisions of the legislation. Regulations provided for in the Queensland legislation have never been made rendering that

legislation ineffective. Since 1985 three States have revised legislation providing a legislative framework within which animal e xperimentation can be controlled and monitored by the

go v e rnments in those States.

14. 10 The Committee now briefly describes the main provisions of Stat e and Territory legislation.

New South Wales

14 . 11 decided Unlike the other States, the New South Wales Government to enact separate legislation to control animal

e x peri mentation rather than include it in prevention of cruelty to animals legislation. The New South Wales Government took this decision because it believed that the community's attitude to a nimals had changed and that it was no longer appropriate to

c onsider animals used in experiments just from the point of view o f cruelty. The philosophy of the legislation is summarised in

the following terms:

1 4 . 12

the twin tenets of this legislation are

the concepts first of enforced self regulation and second of public participation in the

decision-making process.!

The Act requires the accreditation of institutions

in which animal experimentation is conducted . Individuals doing experiments on animals must either be authorised by an accredited i nstitution or, if the research is not done within an accredited institution, licensed by the Secretary of the Department of Local Government . It is a precondition for accreditation that an

institution have established a properly constituted animal care a nd ethics committee .

215

14.13 The animal care and ethics committee required under the NSW legislation has the following functions:

14.14 by the

supervise licences.

14.15

(a) the making of recommendations concerning the granting of animal research authorities by the establishment; the supervision of the carrying out of

animal research by holders of animal research authorities granted by the establishment; and (c) such other functions may be conferred or imposed on it by the Code of Practice.2

Animal care and ethics committees may also be appointed Secretary of the research the Department of

of the holders of

Local Government t o individual research

The constitution and procedures of these committees will be prescribed by regulation. The Act, however, does require that at least one member of such a committee be a person who is

neither associated with any accredited research establishment no r involved in the conduct of, or the supply of animals for, ani mal research.

14.16 The Act also requires that an animal supplier's licence be obtained by a person wishing to supply animals for use in

animal experiments.

14.17 The Act provides for a code of practice to be prescribed

in regulations. This may be the NHMRC/CSIRO/AAC Code of Practice, an amended form of it or an entirely different code of practice.

14.18 The Act also establishes the Animal Research Review

Panel which has the following responsibilities:

investigation of applications for accreditation by corporations or for individual licences and reporting on them to the Secretary of the Department of Local

Government;

216

1 4.1 9

investigation complaints of

and report

breaches of to the Secretary on

conditions upon which

accre ditation was granted, or upon which research or animal supplier's licences were issued;

investigation of matters relating to the conduct of animal research and the supply of research animals;

investigation and evaluation of the efficacy of the Code of Practice in regulating animal research; and

such other functions as the Minister may confer upon it.3

The Secretary of the Department of Local Government, not t he Panel, issues licences and grants accreditation or cancels or

suspends them where breaches of conditions have occurred. The Secretary is obliged to refer matters to the Panel but is not

o blige d to act in accordance with its reports. Appeals from

d e cisions of the Secretary may be made to the District Court .

14. 20 The Act provides for the appointment of inspectors, who

mu s t be registered veterinary surgeons. They are given powers to

enter research establishments, search for and examine animals, e quipment and documents connected with animal experimentation.

Vi ctoria

14 . 2 1 The Prevention of Cruelty to Animals Act was revised in

19 8 5 to provide, among other things, a legislative framework for the c ontrol of animal experimentation in the State.

217

14.22 The Act provides for the supervision of anima l

experimentation at three levels:

a> ethics committees operating within institutions;

b> peer review committees; and

c> authorised inspectors appointed by the Minister.

14.23 Provision is made for the registration of experimenters as well as for the licensing of scientific establishments and

breeding establishments.

14.24 To gain registration as an experimenter, a person must

be a legally qualified veterinarian, dentist or doctor, or must hold a masters or doctoral degree in animal biology.

Experimentation done under the

experimenter.

in a licensed direction or scientific establishment must be supervision of a registered

14.25 An animal experimentation ethics committee (ethics

committee> must be set up by a scientific establishment as a

condition of obtaining a licence. The Act does not specify

qualifications provision to must, however:

for membership or the number of members. There is make regulations on such matters. The committee

14.26

· approve all research by persons other than registered experimenters and ensure that such research is

supervised by a registered experimenter;

approve, before commencement, all 'scientific

procedures' carried out at a scientific establishment and all field work.

An ethics committee must also give prior approval to

'scientific procedures' proposed by registered experimenters.

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14.27 Ethics committees must report to the licensing authority (the Director-General of Agriculture and Rural Affairs) on all approvals granted for work conducted outside the institution.

14.28 The Act provides that the Minister may establish peer

r e view committees and determine terms of reference for these

c ommittees, scientific in relation to any aspect of scientific procedures or research at one or more licensed scientific

establishments. ·These committees are intended to be investigatory and advisory and are to have at least five members - one with

experience in animal welfare and the remainder with expert

knowledge relevant to the inquiry. A peer review committee on l e thal dose testing has been appointed.

14 . 29 The third level of supervision is provided .bY inspectors <'authorised officers'). They are appointed by the Minister and

may enter premises, inspect animals and facilities, issue orders requiring the treatment, feeding, housing or destruction of

animals, and require persons to provide information. Five

inspectors have been appointed.

14.30 The Act itself does not set out standards for the

welfare of animals. The intention is that standards should be set in codes of practice which may be varied or revoked by the

Minister with the approval of the Governor in Council. The NHMRC Code of Practice has been incorporated in the Code of Practice Relating to Animal Experimentation gazetted in the Victorian Government Gazette of 4 March, 1987.

South Australia

14.31 The South Australian Government revised the Prevention of Cruelty to Animals Act in 1986.

219

14 . 32 Under the revised Act, institutions or organisations are licensed by the Minister

responsibility for this bodies do not have to

legislation> be licensed and employees of those

individually to conduct

experiments on animals. The Act is worded in a way to allow an

individual to be licensed if that person does not belong to a

licensed body, provided that the person meets the criteria

required for licensing.

14.33 The establishment of an ethics committee of the type

specified in the Act may be among the conditions imposed on the licensee at the discretion of the Minister. However , the

Minister's second reading speech on the legislation stated:

Research or teaching institutions will be

required to create Animal Ethics Committees to examine and approve all work using animals. Ethics committees will also have

responsibility to ensure that animals used in their institutions are humanely treated.4

14.34 The composition of an animal ethics committee, at the

institutional level, is to consist of at least four members

appointed by the Minister - of whom at least one shall be a

veterinary surgeon; one a person engaged in teaching or research involving animals; one a person responsible for the daily care of research/teaching animals; and one a person 'with an established commitment to the welfare of animals'.

14.35 The functions of an animal ethics committee include:

approve the use of animals in the experiments proposed by the

licence holder; approve the acquisition of animals by the licence holder; ensure that animals involved in teaching or research are treated humanely and relevant regulations complied with; and prepare annual returns for the Minister.

220

14.36 There is a right of appeal to the Minister against any

decision of an animal ethics committee, with a further right of appeal to the Supreme Court.

14.37 The Act also establishes an Animal Welfare Advisory

Committee, consisting of eight members appointed by the Governor.

14.38 The functions of the Advisory Committee are to advise

the Minister on the operation and administration of the Act,

which covers a wide range of animal welfare concerns in addition to animal experimentation; to report on legislative proposals; to examine proposed codes of practice; and to report on matters

referred to it by the Minister. The Committee has no role in the granting or revoking of licences.

14.39 It is intended that detailed standards be set by way of

regulation. This includes incorporation of a code of practice into the regulations.

14.40 Because the current Code of Practice is undergoing

revision it has not been incorporated into regulations. Until the revised code is available, it has been a condition of licences

that all experiments on animals will be conducted in accordance with the current Code of Practice, where that Code does not

conflict with the Prevention of Cruelty to Animals Act 1985.

Tasmania

14.41 Act 1925. The relevant act is the Cruelty to Animals Prevention

14.42 With respect to animal

permissive rather than regulatory. Act reads as follows:

221

experimentation the Act is The relevant section of the

14.43

5 - (1) Any person who does any act or omits

any duty whereby unnecessary suffering is

caused, or likely to be caused, to any animal

shall be deemed guilty of cruelty to such

animal. <2> Without limiting the generality of subsection (1), but subject to the provisions of subsection <3>, the following acts and

omissions shall constitute cruelty to the

animal concerned ...

Except for medicinal or curative purposes or for the purposes of scientific

research, administering to it any drug or any toxic or noxious substance; Except for the purposes of scientific

research, wilfully and unreasonably

administering to it any poisonous or

injurious drug or substance.

In Tasmania, therefore, there is no legislative

framework for the regulation of animal experimentation.

Queensland

14.44 Legislative requirements for the regulation of animal experimentation are included in the Animals Protection Act

1926-1981.

14.45 The relevant section of the Act contains the following

provisions:

7. Exemptions. <1> Except as hereinafter

provided, nothing in this Act shall render

unlawful ...

Any vivisection or other experiment

performed on any animal in accordance with regulations made by the Governor in

Council for the humane conduct of such

experiments, by any person who is

duly

authorised by the Home Secretary to

perform such experiments; <2> The exemption in this section contained shall not take effect:

222

14.46 control

(a) In any case of ill-treatment; or

experiment as described in paragraph

following conditions are neglected, that is to say:-

accordance with the said regulations;

shall, during the whole time thereof, be so under the influence of some anaesthetic as to be insensible to pain;

the operation been so injured that its

recovery would involve serious suffering, it shall be destroyed while still insensible in accordance with the said regulations;

operation shall not be subjected to another.

Provision is both animal made for the making

experimentation and of regulations the granting

authorisations to carry out

been made

such under experiments. However,

have this section of the

to

of

no

Act . regulations Regulation of animal experimentation by the State government has therefore been inoperative.

14.47 The Queensland Police Department, which administers the Animals Protection Act, is reviewing animal welfare legislation and advertised in January this year for written submissions with a closing date of 25 March 1989.

Western Australia

14.48 The regulatory provisions dealing with animal

experimentation are contained in the Prevention of Cruelty to Animals Act 1920-1976. These provisions are similar to those contained in the Queensland legislation. They are as follows:

6. (1) Except as hereinafter provided, nothing in this Act shall render unlawful:

223

any vivisection or other experiment

performed on any animal in accordance with regulations made by the Governor for the humane conduct of such experiments, by any person who has

regulations> been duly authorized by the Governor to perform such experiments, and whose authority in this behalf the

Governor has not withdrawn; or any operation of the nature of an

inoculation or of a feeding experiment. <2> The exemption in this section contained shall not take effect: in any case of ill-treatment; or

in any case of vivisection or other

experiment as described in paragraph wherein the following conditions are

neglected, that is to say:- the operations shall be performed in

accordance with the said regulations; the animal subject to the

shall, during the whole time thereof, be so under the influence of some anaesthetic as to be insensible to pain; when the animal has in the course of

the operation been so injured that its

recovery would involve serious suffering, it shall be destroyed, while still insensible; (iv) an animal which has suffered one

operation shall not be subjected to another.

14 . 49 Regulations have been made under this Act. They are

entitled: 'Prevention of Cruelty to Animals Act - Control of

Vivisection and Experiments Regulations, 1959 ..• ' They make

provision for the issuing of an authority to perform vivisection and experiments, the attachment of conditions to the authority, the withdrawal of an authority, the regulation of operations and the supply of information on experiments by authorised persons to the Commissioner of Public Health.

Australian Capital Territory

14.50 Animal experimentation in the A.C.T. is regulated by the Prevention of Cruelty to Animals Ordinance 1959.

224

14.51 As in the Western Australia and Queensland Acts

experiments and vivisection are excluded from the definition of acts of cruelty and aggravated cruelty. The Ordinance states:

7. The last two preceding sections of this

Ordinance do not apply to an act done:

in an experiment or vivisection performed on an animal for the purposes of

scientific investigation in accordance with conditions, if any, determined by the Minister of State for Health by a person, or by a person acting under the direction,

control and supervision of a person, who-(i} is a legally qualified medical or

veterinary practitioner, or being a graduate of a university, is engaged in biological

research; and is authorised by the Minister of State for Health, to perform experiments and

vivisections on animals.

1 4 . 52 The power to issue authorisations was delegated by the

Minister of Health to the Chairman of the A.C.T. Health Authority some years ago. However, the abolition of this office was

a n nounced in September 1987, by the Minister for Arts, Sport, t he Environment, Tourism and Territories.

14.53 draft

A review of the Ordinance has been completed and the

revised policy has been subject to publ ic comment.

However, with the recent transfer to self-government, the new Legislative Assembly has not yet had time to consider the revised policy and pass legislation to bring the policy into effect.

Northern Territory

1 4 .54 Provision for the regulation of animal experimentation is contained in the Northern Territory of Australi a Prevention of Cruelty to Animals Act.

225

14.55 Animal experimentation is exempted from being classed as acts of cruelty as defined by the Act under certain conditions. The provision reads:

14.56

21. Exemptions (1) Except as hereinafter provided, nothing contained in this Ordinance shall apply to any act done in any of the following cases:

In any experiment or vivisection performed upon any animal by any legally qualified medical practitioner or veterinary

practitioner or any officer authorised by the Minister, for purposes of scientific investigation; <2> Nothing contained apply to any case

ill-treated, or pain to any animal, by any

in subsection (1) shall where an animal is

is unnecessarily caused person.

The authorisation provision is, to all appearances, not being used at all.

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CHAPTER 15

PROPOSED REGULATORY SYSTEM

I Introduction

15.1 There are a number of ways in which animal

experimentation can be administered and those are examined in t his chapter in the light of Australian and overseas exper ience .

The various administrative systems mainly differ according to the level o f government involvement.

15.2 At one end of the spectrum is a system in which there i s

no government control or intervention, with all decisions on a nimal experimentation being taken by institutions within which

t he experiments will be performed. Before 1985, a self-regulatory system similar to that described was. in place. The only external c ontrol was a requirement by a number of funding bodi es for

experimenters and institutions to comply with the Code of

Practice. However, monitoring by funding bodies for compliance with the Code of Practice was virtually non-existent . It was left t o the integrity of institutions and their sense of

responsibility to ensure that animal experimentation was

performed in i nstitutions,

accordance with the responsibility was

experimenters themselves.

Code of largely Practice. In ma n y devolved to the

15. 3 At the other extreme, one can have a totally regulated

system where government takes responsibility for approving protocols involving experiments on animals and for monitoring to ens ure that stipulated standards of animal use and care are

adhered to by experimenters and institutions.

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Regulation or Not

15.4 Within areas of animal welfare, the basic question

which is always raised is whether to have some form of government regulation or none at all. Animal welfare organisations have generally advocated government regulation while users of animals have supported self-regulation with little or no government involvement.

15.5 Until recently in Australia, animal experimentation was conducted with virtually no interference from government

authorities. Before the introduction of ethics committees, there was no mechanism for reviewing protocols to determine whether research projects were designed in accordance with the provisions of the Code of Practice.

15.6 The history of ethics committees in Australia, as

evinced by the Committee, is one of varying levels of success, with some acting merely as a facade to keep authorities and the community at bay. Others have diligently applied themselves to the task of examining protocols to ensure that ethical standards are maintained and that protocols comply with the Code of

Practice. There is no doubt, however, that in recent years there has been a marked change in attitude towards the functioning of ethics committees with the result that many more ethics

committees now operate in accordance with the Code of Practice.

15.7 In its submission ANZFAS argued:

In order to achieve uniformity throughout the country in such matters as the assessment of research protocols by AEECs, the issue of

licences, animal care and husbandry etc,

ANZFAS recommends a comprehensive network of monitoring bodies be established. This network would vest some control at state level while ensuring consistency between states through

the establishment of a statutory national

body.

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15.8

The monitoring network must include checks and balances to achieve the objective of rigorous monitoring of animal experimentation. The network would incorporate:

institutional animal experimentation ethics committees

State and Territory Advisory Panels, a National Assessment Panel, and

an independent federal Inspectorate which would report to the National Assessment

Panel.l

ANZFAS questioned the effectiveness of the ethics

committees to review protocols and to monitor animal houses and research programmes. It acknowledged that some ethics committees fulfil their responsibilities ensure that a more consistent

committees, it recommended that

but others do not. In order to

approach is taken among ethics a National Assessment Panel be

established to conduct, among other things, site visits along the lines of those carried out by panels of the Canadian Council for Animal Care. It proposed that the aims of site visits should be to:

review all facets of the use of animals in research, teaching and testing, to assess the procedures and facilities for animal care, to note and comment on situations that are not in compliance with the Guide and to report to the Council and the institution the panel's

observations and recommendations. The concern of the assessment panel is to assist the local animal care committees and the administration in achieving and maintaining a high standard

of animal care, use, management as well as

procurement and expertise.2

The National Assessment Panel would be a division of a national statutory authority that ANZFAS had recommended in its earlier submission for the administration of animal welfare generally in Australia. Other functions of the National Assessment Panel

include:

229

to sponsor

made available by the Federal Government) regional workshops to improve the function of Animal Experimentation Ethics Committees

to ensure a significant . annual minimum

reduction in percentage terms of the number of live animals used in research

to establish the educational standards

required for researchers and other

laboratory personnel

to supervise the effective implementation and maintenance of national standards ...

for animal experimentation by, inter alia, a system of site visits

to disseminate information on non-animal alternative techniques to researchers, Animal Experimentation Ethics Committees and others

to investigate

matters relating or supply or

organisation

at its discretion any

to the conduct of research care of animals in any

to promote (from a budget which should be

made available by the Federal Government> any research into non-animal alternative techniques

to obtain expert advice relating to the

discharge of its functions

to make an annual report to the responsible Minister to be laid before Parliament

to receive reports

Inspectorate

from the federal

to receive reports from the State and

Territory Advisory Panels.3

15.9 The federal Inspectorate would be another arm of the

national statutory authority. ANZFAS proposed that inspectors appointed by the Inspectorate have wide powers to enter and

inspect premises; and to remove, treat or euthanase animals .

Inspectors would also have the right to recommend the suspension or revocation of licences.

230

15.10 The State Advisory Panels, which would be composed of

equal numbers of experimenters and animal welfarists, would be responsible for the licensing system and would hear appeals from any member of an ethics committee against a decision of an ethics committee.

15 . 11 ANZFAS also recommended that both experimenters and

institutions in which experiments are conducted on animals be licensed by the State Advisory Panels.

15 . 12 The monitoring network proposed by ANZFAS allows for a high degree of control over the conduct of experiments on

animals, based on a blend of the strict controls imposed over

animal experimentation in the United Kingdom and the system which has evolved in New South Wales, Victoria and Australia.

The Committee noted, however, that ANZFAS did not recommend the centralised protocol approval system in the United Kingdom. In that system, protocols are approved by the government

Inspectorate. ANZFAS commented that a government Inspectorate did not have the flexibility of the system of ethics committees

developed in Australia and questioned whether the Inspectorate had a broad enough expertise to assess protocols.

15 . 13 In its submission, the AVCC argued principally for a

system of self-regulation:

First, the fundamental issue concerned with animal welfare is that in each instance a

decision has to be made whether to use animals in teaching and research and this involves

resolution of conflicting ethical claims. The law can only be effective when the community has reached a moral decision or consensus. The limitations of the law, when this consensus does not occur, are exemplified by its

failures to be effective in other areas of

social and moral conflict.

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Second, legislation can act against good

ethical concern. By embodiment of decisions within the law difficult issues are avoided. There is the danger that when actions are

approved under legislation in the form of a

license or a stamp of approval, the

investigator may feel that as long as the law is not contravened there is no need for

further ethical consideration of his actions. Third, previous attempts

control have proven to

limitations, and indeed

counter-productive ... '4

at legislative have serious

to have been

15 . 14 The AVCC went on to accept the need, in a system o f

self- regulation, for external monitoring to ensure

accountability. Its preference was for this external monitoring to be conducted by a non-government organisation without

legislative backing. It suggested developed by the Canadian Council commented:

a system similar to that

for Animal Care. The AVC C

The Canadian model attempts to assure

accountability first and foremost by an

internal review committee and second by an

external assessment panel. The mode of

operation of both committees is to act

primarily in an advisory capacity. The

relationship of internal committees to the scientist is as the ethical adjudicate, the

consultant and advisor. Similarly the external assessment panel operates primarily in an

advisory capacity. However, both committees have considerable powers and can stop or

modify animal-based research and can recommend removal of external funding if there is

serious evidence of non-compliance ...

Assessment by external advisory panels

provides surveillance over animal use and

care. Such assessment panels should be chosen from a pool of persons with expertise in a

variety of fields, including animal

production, care and use. Panels should be

selected as far as possible with reference to the predominant research interests in the

institution to be reviewed. of bona

fide animal welfare organisations should be invited to join the site visit team.S

232

It therefore recommended that an autonomous Australian Council on An imal Care be established modelled on the Canadian system.

15 . 15 The proposed Australian Council on Animal Care has since been established as the Australian Council on Animal Research and Te aching

constitution of ACCART. This function has been taken over by some State Governments.

15.16 Although the AVCC preferred non-government monitoring of animal experimentation along the lines of that conducted by the Canadian Council on Animal Care, the reluctance of some

organisations involved in the establishment of ACCART to support an accreditation function for the Council and the action taken by three State Governments to legislate for government licensing and monitoring in their States have forced the AVCC to reassess their original position. Nevertheless, the AVCC remains firmly attached

to the principle of experimenters and institutions assuming prime responsibility for their use of animals in experiments and are in fact accountable for such use.

15.17 The Australian Society for Medical Research argued in

its submission for self-regulation without external monitoring but stated that if external monitoring were considered necessary, it should be done by the NHMRC . However, a representative of the Society supported a position beyond external monitoring by the NHMRC. In answer to a question on the incorporation of codes of

into government regulations, Dr I.L. Campbell told the p r actice Committee:

This is a good move as long as the people who

are involved in policing these regulations are fully qualified and fully aware of scientific procedures and animal use in animal

experimentation. We would welcome any

233

regulations that improve the use of animals in animal experimentation and oversee the ethical and humane use of animals. We have no

objection. We welcome that sort of

legislation.6

15.18 A similar view was expressed by the Australian Society for Laboratory Animal Science in its submission:

We believe that the control of the use of

animals in research should be in a uniform

manner. Where possible we believe a system of self-regulation is preferable but recognise that this may need to be embodied in State

legislation. Nevertheless uniformity of intent and standards of practice should apply.?

15.19 There was general agreement during the inquiry that

neither self-regulation nor a totally regulated system was

desirable . It became instead a question of the extent of

government regulation and the nature of the administrative

structure to control animal experimentation.

15.20 Although the Committee received a wide range of views in submissions and oral evidence at public hearings, there was

general endorsement 0f a number of key elements in a control

system for animal experimentation.

15.21 As clearly enunciated in the draft revised Code of

Practice and generally suppor.ted in evidence, primary

responsibility for animal use and care rests with the senior

experimenter. The senior experimenter is responsible for the design of the project, the conduct of the experiments and the

care and welfare of the animals used in the experiments. A senior experimenter who is conscious of his ethical responsibility towards the use of animals will achieve more for animal welfare than what can be achieved by the most stringent of monitoring or

234

supervising systems. Conversely, an uncaring senior experimenter can cause much unnecessary pain and distress to animals, even in a system where monitoring occurs. It is vital, therefore, to

instil in experimenters early in their careers an ethical,

responsible and caring approach to the use of animals in

experiments.

Ethics Committees

15.22 protocols Although operations generally

The use of ethics committees to consider and approve also received widespread support during the inquiry. there were differences of opinion expressed about the and membership of ethics committees, the concept was

acceptable. There was virtually no support for the

British system which required government inspectors to approve protocols. As pointed out by ANZFAS, this system lacks

flexibility. There was concern that government inspectors do not have the breadth of expertise to make decisions on protocols

covering a diverse range of proposed projects.

15.23 The Committee discusses aspects of ethics committees in Chapter 16. It is suffice to say here that ethics committees need to operate properly for the system to be effective. This means that the committees must meet to consider and make decisions on protocols. It is not acceptable for ethics committees to delegate that responsibility to sub-committees or individuals or to fulfil that function by correspondence. The Committee is pleased to note that the draft revised Code of Practice requires ethics

committees to conduct its deliberations along these lines .

15.24 There has been a reluctance on the part of institutions

to appoint non-scientists to ethics committees. With few

exceptions, ethics committee membership has included the minimum number of animal welfare or community representatives. Yet the

235

institutions which have appointed representatives of animal welfare organisations to their ethics committees spoke favourably of the positive contributions made by those representatives.

15.25 The Committee examined the Swedish system of regional

ethics committees. The Swedish system differs markedly from the Australian system in many respects. In Sweden, there are only six regional ethics committees and an additional one for military research. The committees are large, with two having had 45

members. They consist of equal numbers of researchers, animal technicians and lay people. They are advisory but their advice on protocols has generally been accepted. Protocols are considered initially by sub-committees of three people, one from each of the three categories of membership.

15.26 The Swedish system has not been without its critics. The criticism has centred on the performance of lay people, many of whom have been hostile towards the use of animals in experiments. The prolongation of debate, both in sub-committees and in the regional ethics committees, has caused delays in the approval of protocols and this has been a source of frustration to some

members of the ethics committee. This has had the effect of

dissuading many researchers and technicians from volunteering for membership of the ethics committees. The large size of some

committees has accentuated the problem because it had facilitated delaying tactics where they have been pursued by lay members.

15.27 The Committee believes that the institutional ethics

committees in Australia have more flexibility and are less

cumbersome than the Swedish ethics committees. The Australian system places greater emphasis on individual responsibility and peer pressure. This helps to inculcate in experimenters desirable ethical attitudes to animal use in experiments. It is also

desirable that the ethical committees make the decisions rather than act just as advisers to a government department or

authority.

236

15.28 With few animal welfare or community representatives

appointed to ethics committees in Australia, there has been

little opportunity for intransigence on philosophical lines. The potential for that type of problem is considered to be minimal in Australia. In the first place, the institutions select the

members of the ethics committees. People with inflexible views towards animal experimentation will not be chosen to sit on

ethics committees. Institutions can always have members of ethics committees removed if they are unreasonably obstructive.

15.29 All members of an ethics committee have a responsibility to act constructively to ensure that protocols are designed in accordance with the Code of Practice. That does not prevent any member from drawing attention to or arguing against protocols which do not seem to comply with the Code of Practice. Often it

is a matter of fine judgement whether a protocol is considered to be in compliance with or in breach of the Code of Practice. All

members should in those circumstances strive to achieve

consensus.

15.30 Apart from the approval of protocols, ethics committees have other important functions to perform. They are required to monitor approved projects within their institutions to ensure that the projects are conducted in accordance with their

approvals. This includes monitoring the number and species of animals used and the type of procedures carried out on those

animals. Ethics committees are or should be accountable for the conduct of animal experimentation within their institutions to the government units which have responsibility for the

legislation.

15.31 Ethics committees also are responsible for ensuring that animal facilities and standards of animal care are maintained in their institutions. Members of ethics committees must regularly visit animal houses and animal holding areas to ensure that

everything is in order. Ethics committees must also keep in close

237

contact with animal house staff to ensure that experimenters adhere to ethics committee approvals and the provision of the Code of Practice. If the director or senior technician of an

animal house is not a member of the ethics committee, he should at least attend their meetings.

15.32 It is much more satisfactory for all concerned if

problems are dealt with properly within institutions rather than action having to be taken later by inspectors or accreditation panels. Ethics committees need to remain alert for breaches of standards or of the Code of Practice and take swift action to

resolve any problems.

15.33 Ethics committees need to keep full records of all

decisions made and of animal breeding, purchase and use. These records must be available for inspection by inspectors at any time. The keeping of comprehensive animal house records should not be regarded as an imposition. They are essential for

efficient animal house management. Such records, where possible, should be computerised.

Code of Practice

15.34 Although differences of opinion were expressed in

evidence on specific provisions in a code of practice, there was general agreement that there should be a national code of

practice. A code of practice sets out principles, administrative systems and animals. In

general standards covering the use and care of

the draft revised Code of Practice, the

responsibilities of experimenters, institutions and ethics committees are clearly defined.

15.35 Witnesses argued for a national code of practice so that uniform standards would apply throughout Australia. The Committee believes that this is desirable provided that there is no

diminution in standards of animal welfare in order to gain

238

consensus. However, it would still be within the power of a State or Territory Government to impose stricter conditions in

regulations to supplement the code of practice should a

Government believe that the current Code of Practice does not provide enough control over animal experimentation. The New South Wales Government considered such a course of action after it

received a copy of the draft revised Code of Practice early in

1988. Subsequently, the draft revised Code of Practice was

amended to bring it more in line with a draft code of practice

prepared by the New South Wales Government.

Enforcement and Accountability

15.36 In the following discussion on enfqrcement and

accountability, it should be remembered that under the

Commonwealth Constitution, animal experimentation is primarily a State and not a Commonwealth matter, except where it is being

conducted by Commonwealth authorities. The Commonwealth maintains some involvement in animal experimentation through funding by Commonwealth bodies such as the Australian Research Council, the NHMRC and others.

15.37 Until recently, State Governments did not assume

administrative control over animal experimentation. In 1985 and 1986, the Governments of New South Wales, Victoria and South Australia enacted legislation and established administrative units within their Governments to control animal experimentation.

The Australian Capital Territory and Queensland Governments are presently moving towards revised legislation in this area.

15.38 The Committee received various views on the roles of

funding bodies and State and Territory Governments in the

administration of animal welfare. It is clear, however, that as the States and Territories are moving to take control of the

239

administration of animal experimentation, as is their

constitutional right to do so, primary responsibility for

overseeing animal experimentation should rest with them and not funding bodies.

15.39 Funding bodies still have a role to play in that all

protocols for external funding are considered by those bodies and their referees. Where a protocol obviously does not comply with the Code of Practice, the funding body has a responsibility to

withhold funds for the project until compliance is achieved. However, the funding bodies do not have a role to set up specific administrative structures to enforce the Code of Practice. Their role is to fund research and in some cases to provide advice to

government in accordance with their charters. If funding bodies encroach on the legitimate role of government to administer

animal experimentation, it would only cause confusion and be a waste of scarce resources. Of the funding bodies, only the NHMRC has had a direct role in the compilation and revision of the Code

of Practice. As it funds only a small percentage of all projects involving the use of animals in Australia, it is anyway not in a position ,to take over responsibility for enforcement of the Code of Practice.

Legislation

15.40 Each State and Territory should have legislation to

control animal experimentation modelled on legislation already enacted in New South Wales, Victoria and South Australia.

15.41 It is worthwhile to compare some of the main provisions

of the revised legislation in New South Wales, Victoria and South Australia. Although the three Acts provide a similar framework, there are distinct differences in approach and in specific

requirements. ACCART did a simple comparison and this was

incorporated in the Committee's Hansard transcript of evidence.S

240

15.42 The New South Wales Government decided to enact separate legislation to control animal experimentation while the Victorian and South Australian Governments included such provisions in their prevention of cruelty to animals legislation. Similarly,

the New South Wales Government established an Animal Research Review Panel, separate from the Animal Welfare Advisory Council, to control animal experimentation in that State . In Victoria and South Australia, the Animal Welfare Advisory Councils have

responsibility for animal experimentation as well as for other areas of animal welfare.

15.43 The Committee prefers separate legislation to regulate animal experimentation, along the lines of the New South Wales approach, to get away from the notion of prevention of cruelty and substitute one of care of and respect for animals . Although some experiments cause pain or suffering to animals, deliberate cruelty to animals undergoing experiments in Australia is rare.

It seems incongruous to include animal experimentation in

legislation which is designed primarily to prevent cruelty to animals.

15.44 In many areas of animal welfare, local government or

non-government organisations have responsibility for upholding legislation. However, in animal experimentation, State

Governments are directly involved in accreditation; licensing; monitoring; preparation of legislation, regulations, guidelines and codes of practice; and consideration of many complicated and contentious ethical issues. Government involvement in animal

experimentation is much deeper than in most other animal welfare issues. Although these other issues can reasonably be brought together and considered by a general advisory committee, it is much harder to do this satisfactorily in the case of animal

experimentation. One or two members representing scientific interests on an advisory committee would not necessarily have the breadth of expertise or experience to enable the advisory

committee to give government the best advice on animal

experimentation.

241

15.45 Although the Committee prefers separate advisory

committees for animal experimentation, it believes that a single animal welfare unit within the State bureaucracy should

administer all animal welfare functions as happens in New South Wales, Victoria and South Australia.

15.46 A major difference among the three updated State Acts is the matter of licensing or accreditation of institutions. The Victorian and South Australian Governments adopted the approach of licensing institutions and appointing inspectors to visit

institutions from time to time to check whether facilities are of the appropriate standard and whether other requirements of

legislation and the code of practice are being met.

15.47 The New South Wales legislation provides , for licences for institutions and for the appointment of inspectors. Once

Regulations are issued, licences will be issued to institutions after they have undergone a process of accreditation.

15.48 Accreditation in New South Wales will be no perfunctory exercise. In its submission, the New South Wales Government

stated that accreditation 'incorporates peer review of practices and procedures and therefore mandates critical and informed review and appraisal'. A little later, it went on to say:

15.49

There is no doubt that to be effective the

agent/agency responsible for external

monitoring must have sufficient knowledge to evaluate the practices and procedures and must be able to reflect in its judgement a

'balanced community view'. Assessment by a panel of persons with appropriate and relevant expertise and including community

representative, should achieve this.9

This process will involve some members of the Animal Research Review Panel and other scientists doing a thorough

review of animal and experimentation facilities, inspection of records and examination of ethics committees' decisions to ensure compliance with the provisions of the Code of Practice. As

several members of the accreditation group will have expert

knowledge in various areas under review, a more thorough review

242

compliance with the provisions of the Code of Practice. As

several members of the accreditation group will have expert

knowledge in various areas under review, a more thorough review of the self-regulatory performance of the institution will be done compared with the occasional visits by inspectors to

institutions in systems which do not accredit institutions.

15 . 50 Another advantage of accreditation from the point of

view of the scientific community is that it will install peer

review in the control system at a second level and not just at

the level of ethics committees. Accreditation teams will contain a number of senior scientists who will provide scientific

expertise to the teams. Monitoring will not be done just by

government inspectors who may not have a scientific background and who are not fully familiar with scientific method,

experimental techniques and the subtleties of animal

experimentation.

15.51 The inclusion of animal welfare or community

representatives on accreditation teams will make the monitoring process more publicly accountable. It will also help to allay suspicion on the part of animal welfare organisations that

experiments are being conducted in accordance with the Code of Practice and housing and other facilities for animals are of an appropriate standard.

Monitoring

15.52 A system based on the principles of enforced

self-regulation depends largely on self-regulatory practices; government controls are not meant to be too intrusive. However, legislation without enforcement soon becomes seen to be

ineffective and is treated accordingly. A balance has to be

struck between self-regulation and government controls to ensure that the former works without too much interference from the

latter.

243

15.53 In New South Wales, accreditation will provide a

thorough review of the performance of the institution, its ethics committee, experimentation and facilities at specified intervals of between one and three years. In addition, in all three States which have revised legislation there is provision for the

appointment of inspectors. Their powers and functions are

detailed in the relevant legislation. Basically, they have powers to enter premises, check facilities and records and give

directions in accordance with the provisions of legislation.

15.54 Inspectors have an important role to play in the system

of enforced self-regulation. They need to have had experience in laboratory animal science or relevant veterinary science so that they are familiar with the operations of animal experimentation and animal care. They must be sufficiently experienced to detect non-compliance with codes of practice or other regulations but have qualities of discretion and commonsense to take appropriate action. Often advice or a warning will be preferable to more

serious action. They must gain the respect and confidence of the scientific community with which they have dealings. The

importance of attitude in animal experimentation is the key to the correct approach being taken by experimenters. With a

positive attitude towards ethical use and care of animals, humane treatment is a ready result. Inspectors have a role to play in

helping to inculcate the right attitude among experimenters. As is the case in other areas of life, laws are made to prevent

exploitation. This is true too for animal experimentation. Most people who believe a law is fair and just will respect it but

there will always be someone who will try to circumvent the law for his or her own benefit. It is that person on whom the efforts of inspectors must be concentrated.

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Accountability

15.55 On occasions, it is understandable for institutions and experimenters to become defensive and secretive, particularly in the face of violence or malicious allegations of misconduct or cruelty. However, resort to secrecy should be avoided wherever possible. The best defence is full public accountability. The

community supports animal experimentation which is conducted within normal humane limits. The community will not support

violence against institutions where it can be shown that normal standards of use and care have been followed. In those

circumstances, violence would be counter-productive.

15.56 All people and bodies involved in animal experimentation and in its administration and control need to be ac,countable for their actions, otherwise the system may be brought into

disrepute. Each person or body in the system must carry out its function and keep proper records of action taken.

Summary

15.57 The Committee RECOMMENDS that the system of controlling animal experimentation in New South Wales, Victoria and South Australia be extended to the other States and Territories. This system is based on upgraded legislation; incorporation of a code

of practice in regulations; the accreditation and licensing of institutions in which animal experimentation is conducted; and the appointment of inspectors to monitor the work of ethics

committees, animal house facilities and practices, and the

conduct of animal experimentation.

245

Commonwealth Government

15.58 At the Commonwealth level there have been some problems recently about the administration of animal experimentation which attracted media attention.

15.59 being Code

In the first case, the NHMRC tried to monitor research done by CSIRO with NHMRC grants for compliance with the of Practice. The Committee does not wish to become too

embroi led in the details of the case but merely comments o n

aspects which impinge upon the control of animal experimentation at the Commonwealth level. The Committee has already discussed the question of monitoring for compliance with the Code o f

Practice . It has recommended that, in the States and Territories , the State and Territory Governments do the monitoring under their own legislation in accordance with their constitutional

responsibilities . Consequently, funding bodies would not monitor for compliance unless there was doubt arising from consideration of a protocol or other application for a grant that the Code of

Practice might not be with. The would therefore

not have the power to demand inspection of CSIRO facilities. In any event, it seemed to the Committee odd that the NHMRC would make such demands on a co-sponsor of the Code of Practice.

15.60 Another case where media attention focussed on animal experimentation was in 1988 when allegations were made about the use of uranium isotopes on penguins and also about other research being conducted in Antarctica. This issue was the subject of a government inquiry which has recommended various procedures to obviate future problems with control and monitoring of

experiments on animals in Antarctica. Some of the recommendations of the report on the incident do warrant comment. The Working

Party which produced the report concluded that the existing Code of Practice was unsuitable for experiments on animals in

Antarctica and recommended that a separate code of practice be prepared for Antarctic research. The Committee believes that the

246

Wo rking Party has misunderstood the purpose of the Code of

Pra ctice. The Code of Practice is meant to cover all experiments on animals, irrespective of whether the experiments are conducted in a laboratory or on wildlife in the field - in the blistering

heat of inland Australia or in the cold of Antarctica. The code

is a set of principles and administrative arrangements. It is not a set of detailed guidelines for experiments on specific species

of animal.

15.61 It has been acknowledged by the NHMRC and other bodies

that guidelines need to be compiled on specific species or

particular procedures to supplement the Code of Practice. This is a task for ACCART, specialist societies (e.g. the Primate

Society> or other expert bodies. The Antarctic Division should arrange with people with experience in dealing with animals in Antarctica to draw up guidelines for future projects involving experiments on Al1tarctic animals. However, the

is still appropriate for overall control

animals in Antarctica.

Code of Practice of experiments on

15.62 There are organisations at the Commonwealth level which h ave some involvement in experiments on animals, either as

funding bodies or in an experimental capacity. The controversy over the experiments on animals in Antarctica serves as an

example to show the lack of co-ordination of experiments in

a nimals at the Commonwealth level.

15.63 There is another dispute simmering, between CSIRO and

State Governments, over the constitutional control of a

Commonwealth statutory authority which has activities within a

State. One or two State Governments have claimed that CSIRO staff working in their States have to obey State laws. CSIRO, on the

other hand, has received legal advice from the Commonwealth to

the effect that its staff are not bound by State laws. Despite

this constitutional impasse, CSIRO has voluntarily agreed that its staff should comply with State laws and regulations .

247

15.64 In a submission to the Committee the CSIRO argued for

the enactment of Commonwealth legislation to put the question of constitutional authority beyond doubt. The CSIRO stated:

15.65

The Act should aim to provide a mechanism by

which all members of the community become

aware of their duty of respect for animals and of the necessity for humane treatment of them. As such it should go well beyond the

conventional notion of aiming such legislation at the prevention of cruelty of animals.lO

The CSIRO went on to say in its submission that the

legislation would:

15.66

ensure that standards of

uniformly high and teaching

Australia,

use are

research throughout

animal care and in Commonwealth establishments

facilitate administration within

research Commonwealth departments and funding bodies,

provide a clearly defined uniform scheme within which Commonwealth researchers and teachers are legally protected, and

facilitate good relationships with State and Territory animal welfare authorities.ll

The Committee notes that most tertiary institutions, such as universities, colleges of advanced education and colleges of technical and further education would continue to come under State or Territory legislation.

15.67 The legislation proposed by the CSIRO would cover all

activities of Commonwealth staff irrespective of whether their work is carried out in Commonwealth or State facilities. However, observance of State legislation would be advisable by staff if they are working in State facilities with non-Commonwealth staff to prevent any unnecessary friction between Commonwealth and State authorities.

248

15. 68 The enactment of Commonwealth legislation would enable

a l l Commonwealth staff located throughout Australia to be subject to the same legislative and regulatory provisions . This would o bviate possible confusion about the terms of legislation and

regulations applying to them by staff moving among the States and Territ ories . It also helps an organisation such as the CSIRO with research programmes in all States and Territories to promote a uniform s e t of standards and rules within the whole Organisation.

15 .69 Government The Committee RECOMMENDS that enacts legislation to remove

the Commonwealth any doubt that the

conduct of animal experimentation by Commonwealth employees comes under the control of Commonwealth authorities.

1 5 .7 0 In

establishment Chapter 15, the

of a Commonwealth Committee recommended the AWAC responsible to a neutral

Minister who had been given responsibility for animal welfare

matters by Cabinet. The AWAC would be served by a unit within the Minister's department.

15 . 71 The Committee considered the question of co-ordination and control of animal experimentation at a Commonwealth level. The Committee believes that control should be vested in the

Minister who would seek advice from the Commonwealth AWAC and also from an inter-departmental committee consisting of representatives of the various departments and authorities which have an interest in animal experimentation at the Commonwealth

level. The animal welfare unit within the department would also serve the roc.

15 . 72 Both the Commonwealth AWAC and the IDC could draw upon

ACCART for technical advice on animal experimentation and the

care of animals.

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15.73 The IDC would act as a co-ordinating body under the

chairmanship of the head of the animal welfare unit. It would

discuss new practices, policies, standards, regulations and legislation and examine problems faced by any of the departments or authorities. Some of the bodies would also be represented o n the Commonwealth AWAC which would facilitate communication of the views of the IDC to be considered by the AWAC when issues

relating to animal experimentation were raised in that forum.

15.74 The IDC would advise the Commonwealth Minister !

responsible for animal welfare on animal experimentation matters within the Commonwealth jurisdiction and on other animal

experimentation matters which would be the subject of discussions with State and Territory ministers.

15.75 The Committee RECOMMENDS the establishment of an

inter-departmental departments and committee authorities

consisting of the various

which have an interest in animal

experimentation at the Commonwealth level to co-ordinate and oversee the conduct of animal experimentation to ensure that it is carried out in accordance with the Code of Practice.

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CHAPTER 16

CODE OF PRACTICE AND ETHICS COMMITTEES

Introduction

16.1 In Chapter 15 the Committee recommended the adoption by all States and Territories and the Commonwealth of a regulatory system for animal experimentation based on the systems operating in New South Wales, Victoria and South Australia. The system is based on legislation, the code of practice, ethics committees and

government monitoring. During the course of the inquiry, various issues were raised concerning the Code of Practice and ethics These issues are discussed in this chapter.

Code of Practice

16.2 A key element in the regulatory package is the code of

practice, within the provisions of which experiments on animals are to be conducted. For the provisions to be enforceable, the code of practice needs to be included in regulations made under relevant legislation. There are always some institutions or

individuals who will not comply with the code of practice if it does not have the backing of the law. Not all institutions depend on government funding for their research projects rendering useless the threat of the withholding of grants as a means of

ensuring compliance with the code of practice.

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16.3 The Victorian Government has included the Code o f

Practice in its regulations under the Prevention of Cruelty t a Animals Act. The South Australian and New South Wales Governments will include the draft revised Code of Practice in their

regulations when it has been approved by the sponsoring bodies .

16.4 The New South Wales Government at one stage issued a

draft code of practice which varied significantly from the draft r e vised Code of Practice. The Committee notes that, subsequently,

the writing group revising the Code of Practice amended the draft revised Code of Practice by including many key provisions of the New South Wales draft code. The Committee understands that the

New South Wales Government will probably now adopt the revised

Code of Practice to maintain uniformity with other states.

16.5 It is sensible for there to be a single code of practice l

applying in all States and Territories and in Commonwealth

facilities. That should not prevent a government from imposing extra requirements in regulations to tighten control of animal experimentation. Inevitably, a code of practice is the minimum set of standards which all parties bound by the code are prepared to accept. Some parties may wish to raise the standards within their area of authority. If this improves animal welfare, it

should be encouraged.

Revision of the Code of Practice

16.6 Since 1965 when work was begun on the original Code of

Practice, the NHMRC has had the main carriage of the preparation and revision of the Code of Practice. During most of this period, the responsibility for the adoption of an ethical approach to experiments on animals and for the welfare of animals was left to the NHMRC. The CSIRO and later the AAC jointed the NHMRC in

revising the Code of Practice but it has always been the NHMRC which has provided the administrative support for the Code of Practice.

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16.7 The NHMRC has done a good job in establishing the Code

of Practice and in carrying out its first three revisions.

However, the Committee is aware of difficulties and tensions among the NHMRC, some State Governments and other bodies during the recent revision of the Code of Practice. With the new Code of Practice to be included in regulations in three States and with

responsibility for enforcing compliance with the Code of Practice in the hands of those States, a new approach should be taken for

conducting future revisions.

16.8 In the past, a new edition of the Code of Practice has

come into force when it has received

sponsoring bodies future, the State and

the NHMRC, the CSIRO the approval and the AAC. of its

ilie

Territory Governments which will include

the Code of Practice in regulations should give it final

approval. If the State and Territory Governments were unhappy with a revised Code of Practice, they would withhold their

endorsement anyway and not substitute it for the existing Code of Practice. Alternatively, the Governments would simply amend the revised Code of Practice to bring it into line with their

policies.

16.9 There are many interested parties in revisions of the

Code of Practice - governments, institutions which conduct animal experimentation, . experimenters, animal house staff, specialist societies, animal welfare organisations, educational

organisations and funding bodies. It would be sensible for all of these interests to have an input into revisions of . the Code of

Practice. Each party brings a different perspective to bear on the subject matter of the Code of Practice. As with the

functioning of ethics committees, it is the mix of these diverse views which will result in a Code of Practice which takes account of all of the interests represented.

253

16.10 It has been suggested that a national conference be held

annually to review the Code of Practice to draw attention to any shortcomings or to technological developments which might impinge on the Code of Practice. The Committee believes that the Code of Practice should be revised about every three years unless there emerges from an annual national conference a clear need to

undertake an earlier revision.

16.11 The national conference should have an independent

chairman and should include representatives of Commonwealth, State and Territory animal welfare or animal experimentation advisory councils; AVCC; CSIRO; ASLAS; the Australian Association of Animal Technicians; the Australian Research Council; NHMRC; AAC; the Australian Educational Council; ANZFAS; RSPCA Australia;

NFF; AVA; experimenters; and the community.

16.12 The national conference should consider and agree on the principles and main points for inclusion in a revised draft of the Code of Practice. It would then select a small writing group to incorporate the changes. When the writing group has completed its task, the revised draft would be considered by the national conference before being submitted to State and Territory

Governments for approval. If a Ministerial Council for Animal Welfare were established, the revised Code of Practice would be submitted to it.

16.13 The committee to revise the Code of Practice should draw on the resources of ACCART for technical advice.

16.14 The Committee believes that ACCART should also provide the secretariat for the committee to revise the Code of Practice. ACCART is a neutral body but has many of the interested parties

as members.

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1 6. 15 The Committee RECOMMENDS that future revisions of the

Code of Practice be carried out by a national conference

consis ting of representatives of governments, institutions which conduct staff , animal experimentation, experimenters, animal house

specialist societies, animal welfare organisations, edu cational organisations and funding bodies and that final

a ppr oval for those revisions be given by Commonwealth, State and Terr itory Governments which include the Code of Practice in

reg ulations.

Compli ance with the Code of Practice

16. 16 Until recently, ensuring compliance with the Code of

Practice has been the responsibility of funding bopies . Grants were made to experimenters and institutions for projects

involving experiments on animals on the condition that they

adhere to the provisions of the Code of Practice. Ethics

committees were also required to screen proposals for compliance

with the Code of Practice.

1 6.17 In practice, there was little effort made to secure

c ompliance with the Code of Practice by experimenters and

institutions. Many ethics committees did not carry out their r esponsibilities and some institutions did not even have ethics c ommittees in operation. The NHMRC and other funding bodies had

no resources to monitor compliance and they depended on

s t atements of compliance from experimenters and institutions. The NHMRC in its original submission dated February 1984 to the

Committee stated:

experience indicates that there is

complete compliance with the Code on the part of the medical researchers in Australia.1

16.18 By the time that representatives of the NHMRC gave

evidence to the Committee on 29 August 1986, the view of the

NHMRC about compliance had changed to some extent:

255

There was no evidence in 1984 of lack of

compliance. It would still be difficult to

identify whether or not there is lack of

compliance. It became clear to the Council

that simply asking people to ensure in the

submission of their grant application that their proposal had been examined by an ethics committee and that that ethics committee had put a signature on it was not sufficient for

the Council to be able to be completely

satisfied that compliance was occurring and it was for that reason that Dr Anderson's

committee was asked to provide advice,

information and input on this matter to the

Council.2

16.19 The Committee sent out about 50

and other institutions which questionnaires to conducted animal universities experimentation. From the completed questionnaires, it was quite obvious that many institutions were not complying with the Code of Practice in one way or another. The AVCC, with whom the

Committee liaised during the preparation ·of the questionnaire, analysed the returns from the 19 universities. It acknowledged that there were areas in a number of universities that required changes in practice or procedure.3 In at least two universities, the Committee noticed during its inspections a disregard for the universities' own procedures.

16 . 20 There is no doubt that the Code of Practice has not been

adhered to in all respects. The Committee has noted, however, that during the course of the inquiry, considerable improvements have been made by many institutions in improving facilities and procedures. There has been a growing awareness of the need to

adopt a more ethical and careful approach to the use of animals . This has been not just to reflect changing attitudes within the community but also to acknowledge that improvements · in animal care and use result in more reliable data.

16.21 In November 1985 the NHMRC decided to take a more active

role in monitoring compliance by appointing its own ethics

committee. It was given three functions, the third of which was:

256

With the approval of the Council, to develop

and implement ways of ensuring that all animal experimentation funded by the NHMRC is in

a c cord with the current 'Code of Practice' . 4

16 . 22 The NHMRC admitted in evidence on 29 August 1986 that it

alloc ated o n e clerical officer to administer the committee

althou gh that officer had back-up support within the then

De partmen t o f Health. Dr Anderson added that the Baker Institute provided s ecretarial assistance.5

16.23 The budget of the NHMRC ethics committee was limited and membership was ori ginally restricted to people based in Melbourne in order to c o ntain costs . 6

16 . 24 It is questionable whether the NHMRC or any other

fundi n g body should try to ensure adherence to the Code of

Pra ctice. Obviously, it should keep the requirement that funds should only be disbursed to experimenters and institutions which agre e to comply with the Code of Practice . Any aspect of a

p r oposal for funding which indicates possible non-compliance with

the Code of Practice should be queried and amended if necessary to obtai n compliance. However, for a funding body to go beyond

these measures requires additional resources and runs the risk of causing other problems .

16.25 The NHMRC funds a small proportion of projects in which

experiments are carried out on animals. For the NHMRC to

establish a unit to monitor compliance with the Code of Practice means that it would only cover a small proportion of projects

a nyway . Each funding body would need to set aside resources for this purpose . This would make the system cumbersome and expensive t o operate. Different standards or interpretations mi ght apply

among the funding bodies to add to the other problems.

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16.26 Regulation of animal experimentation is a State

responsibility. A State government may decide to impose stricter conditions on experimenters and institutions than those contained in the Code of Practice. The Code of Practice may therefore

conflict with regulations made under State legislation. This would create problems for a funding body, if it had to police

non-compliance with the Code of Practice. If several States had different regulations, it would compound the difficulties faced by a funding body in ensuring compliance.

16.27 Three States have since 1985 revised legislation and

established mechanisms to control and monitor animal

experimentation. In all three States the legislation has provided for the appointment of inspectors to carry out this monitoring . There are also moves among the other States and Territories for similar provisions to be put in place.

16.28 The Committee firmly believes that the relevant

government authorities in the States and Territories and within the Commonwealth should be responsible for ensuring compliance with the Code of Practice or other regulations made under

legislation. These authorities have a legislative responsibility to carry out this task. With government authorities taking over monitoring of compliance, funding bodies should avoid causing

confusion by trying to duplicate government efforts in this area, except where non-compliance is obvious from proposals or reports of completed or partially completed projects.

Emergencies

16.29 In the draft revised Code of Practice dated 22 February

1989, there is provision for the nomination of a person to

respond to emergencies:

On each site where animals are used, the AEEC should nominate a person who is authorised to respond to emergencies. Where possible, this person should be a member of the AEEC.7

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16 . 30 Although an executive committee of an ethics committee may be authorised to deal with emergencies, it may find it

impossible to respond to an emergency in a remote facility or

e ven one away from the main campus or headquarters area. The

nomination of a person on each site to respond to emergencies

enabl es action to be taken quickly in the event of an emergency . The Committee believes that this is a positive step towards

a l locating responsibility and authority in the interests of

a nimal welfare. The Committee, however, believes that it should be mandatory rather than optional for such nominations to be

ma de .

Animal Welfare Officers

16 .31 In the draft revised Code of Practice which was

distributed for comment in 1988, provision was made for the

appointment of an animal welfare officer in institutions . In the draft, it was stated:

Institutions should consider whether an animal welfare officer should be appointed,

responsible to the AEEC. An animal welfare

officer should have veterinary or other

appropriate specialist qualifications, and may act as the executive officer of the AEEC but

should not be concerned directly with the

day-to-day care or husbandry of the animals. The animal welfare officer must be authorised by the AEEC to ensure compliance with the

requirements of this Code and of the AEEC,

including the treatment or human killing of any animal.8

16.32 The paragraph on animal welfare officers was deleted

f rom the 22 February 1989 draft of the revised Code of Practice.

I n that draft, it was suggested:

Large institutions with multiple sites of

animal care and use should consider whether an Executive Officer with veterinary or other appropriate specialist qualifications should

259

16.33

be appointed. An Executive Officer should be authorised by the AEEC to ensure compliance with the Code and decisions of the AEEC.9

In effect an executive officer has been substituted for an animal welfare officer.

16.34 Few institutions have appointed animal welfare officers although a number have purportedly appointed an animal welfare officer by arranging for a local veterinarian to make periodic inspections of animal houses. Such an arrangement cannot be

regarded, however, as the appointment of an animal welfare

officer. Animal welfare officers are officers who are appointed on a full-time or part-time basis and who, in the latter case,

have other duties within the institution. Apart from carrying out monitoring duties to ensure that the care of animals and

experimental projects are carried out in compliance with the Code of Practice and institutional policies, the animal welfare

officer has advisory and educational roles to fulfil. The animal welfare officer should be developing standards of care and

promoting good animal welfare practice, emphasising the

correlation between good animal welfare and reliable experimental data derived from experiments on animals. None of these roles, including the primary monitoring role, can be done by an external officer making occasional visits to the institution. There is nothing wrong in having veterinarians in private practice

inspecting facilities but such arrangements do not constitute having an animal welfare officer.

16.35 Under the Code of Practice, the ethics committee has

responsibility for monitoring animal breeding and holding areas and for ensuring that experimenters comply with the terms of

approved protocols. No administrative arrangements diminish that responsibility although arrangements can be made to enhance it. Members of ethics committees individually and collectively have to fulfil this responsibility by personally inspecting animal

260

houses and experimentation facilities on a regular basis. It is not enough to delegate this function to an animal welfare officer or executive officer, even though either officer, if one has been appointed, may also monitor those animal houses and

experimentation facilities more frequently.

16 .36 As it

responsibility for Committee believes

is the ethics committee

monitoring that it

standards and is appropriate

that has the

compliance, the for the ethics

committee to appoint an executive officer, with veterinary or other appropriate qualifications, to support it administratively and in its roles of monitoring, development of standards and

education. Although it may only be a question of nomenclature, the use of 'executive officer' does reflect the responsibilities of the position and the ethics committee more clearly and it

precludes the use of 'animal welfare officer' for public

relations purposes only as is the case in a number of

institutions at present.

Ethics Committees

16.37 The second edition of the Code of Practice required

institutions which conducted experiments on animals to establish ethics committees to scrutinise and approve protocols for

projects in which animals were involved. Since then, institutions have gradually established ethics committees although the

effectiveness of some has been questionable. The Committee is aware of some ethics committees that had not met until recently or that examined protocols in a cursory way to comply with the

letter of the 'law' but not its spirit.

16.38 Ethics committees are the lynch pin in the system of

responsibility and accountability in the three States with

upgraded legislation. The effectiveness of the ethics committees will determine whether the system is successful or not. In the

261

other States and Territories, they are virtually the only control over animal experimentation. Ethics committees consider al l protocols for experiments on animals and they may approve, amend or reject protocols for non-compliance with the Code of Practice . They control, therefore, all experiments on animals and they have

the responsibility for ensuring that experiments conform to acceptable ethical principles in accordance with the Code of Practice.

Membership of ethics committees

16 . 39 Membership of ethics committees is important because it determines the diversity of views that consider protocols and other business of the committees. A narrow spectrum of views

consisting mainly of scientific values would tend to appraise proposals less critically than a membership which reflected both scientific and community attitudes.

16.40 The ethics committee is also a key element in the system

for public accountability. By having animal welfare and community views on an ethics committee, the community has more confidence that the ethical attitudes of the community are being reflected in the judgements and decisions of the committee. The Committee believes that it is essential not only for community interests and attitudes to be the basis of decisions of an ethics committee but also for those decisions to be perceived by the community as reflecting its views.

16.41 Under the 22 February 1989 draft revised Code of

Practice, the ethics committee must comprise at least four

members, including one from each of the following categories:

Category A. a person with qualifications in veterinary science, preferably with experience relevant to the activities of the institution, or a person with qualifications and experience to provide equivalent expertise;

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1 6 . 42

Category B. a person with substantial recent experience in animal experimentation;

Category C. a person with demonstrable

commitment to, and established experience in, furthering the welfare of animals, who is not employed by or otherwise associated with the institution, and who is not involved in the

care and use of animals for scientific

purposes. The person should where possible be selected on the basis of membership of an

animal welfare organisation;

Category D. an independent person who does

not currently and has not previously conducted experiments using animals, and who is

preferably not an employee of the

institution.lO

The Code of Practice provides for additional people to be appointed to an ethics committee. Most ethics committees have a larger membership to reflect the diversity of research which has to be considered by the committees.

16.43 Although the person representing Category D may be

appointed from within the institution, it becomes mandatory for two people from Categories C and D to be external appointments if the ethics committee has more than seven members .

16 . 44 The draft which was distributed for public comment

required the person appointed under Category D not to be an

employee of the institution.

16.45 The Committee sought the views of a number of people at

public hearings on the composition of the ethics committees as set out above. At that stage the draft Code of Practice was

sub ject to public comment. The only reservation about the

membership categories that was elicited from witnesses was the requirement for the appointment of two people who have no

affiliation with the institution. It was argued that a lay person wi thin the institution, such as a professor of philosophy, would be appropriate to represent community interests. It was not

263

asserted that two people should not be appointed from outside t h e institution but that there should be more flexibility so that o n e of those two might be appointed from within provided that the

person was suitable.

16 . 46 Although a suitable person may be found within an

i nstitution to f i ll the lay person category, the Commi t tee

beli eves that , on balance, it is preferable to appoint f r om

outs i de of i nstitution two people who have no involvemen t in

animal experimentation. There can be no question then of loyalty to the i nstitution clouding their judgement on sensitive or

controversial protocols or other issues. An external appointment under Category D is more likely to ensure that community v i ews and atti t _ udes are reflected than an internal appointment, h owever well qual ified the latter may be for membership of an e thics

committee . It also means that the one outside member is not

overwhelmed by internal members in meetings of the committee . As most ethi cs committees require unanimous deci sions, there may be pressure brought to bear on a single dissenting member. It may put a single dissenter into a difficult position if he or she is

the sole outside member on the committee.

16.47 An eminent philosopher within an institution can still be appointed to the ethics committee when an external appointment is made under Category D as there is no upper limit on the number of people appointed from each category. It has been only a matter of institutional policy that has resulted in the number o f

non-scientists being kept to a minimum on ethics committees .

16.48 The Committee supports the membership provisions of

ethics committees as drafted in the draft revised Code of

Practice which was originally published for public comment, that required the community representative to be a person not employed by the institution.

264

16.49 Under the draft revised Code of Practice, there must be

at least one person appointed from each of the four categories . At present, as long as each category is represented, one person may represent more than one category. For example, veterinarians in private practice have often been appointed to ethics

committees to represent veterinary science, animal welfare and an external appointment in the one person. This will not be allowed when the revised Code of Practice comes into effect. The

Committee supports this change in policy.

16.50 The appointment of a member under Category C 'should

where possible be selected on the basis of membership of an

animal welfare organisation'. There is an obvious need for

flexibility in this provision because in some areas there may not be a suitable person who is a member of an animal welfare

organisation available for appointment to an ethics committee. However, the tlexibility of the provision should not be used as

an excuse not to appoint a member of an animal welfare

organisation where one is available. Institutions should make appointments within the spirit and not merely the letter of the provision. In emphasising this point, the Committee believes that members of animal welfare organisations who are appointed to

ethics committees must fulfil their responsibilities as members in a way that enables the ethics committees to operate

effectively. In other words, there is no place on an ethics

committee for people who simply want to obstruct the work of

ethics committees because they have a philosophical objection to animal experimentation. The Committee noted that a number of members of ANZFAS and RSPCA have been effective members of ethics committees. By having a different perspective, they have

persuaded ethics committees to consider some protocols and issues in a different light.ll

265

Consideration of Protocols

16.51 The manner of considering and approving protocols became a controversial issue during the course of the inquiry. A number of ethics corrunittees have been dealing with protocols by

correspondence and not at meetings of the corrunittees. In some cases, consideration and approval of protocols have been

delegated to one or a few members of an ethics corrunittee.

16.52 Under the current Code of Practice, the constitution of ethics corrunittees must include provisions to:

16.53

examine written proposals relevant to the use of animals in experiments and approve only those experiments which conform to · the

requirements of this Code, taking into

consideration ethical aspects as well as

scientific or educational merit;12

The 19 February 1989 draft revised Code of Practice has four clauses which deal with consideration of protocols. Ethics corrunittees must have terms of reference which include provisions to:

examine and approve, approve subject to modification, or reject written proposals relevant to the use of animals in experiments and approve only those experiments for which animals are essential and which conform to the requirements of this Code, taking into

consideration ethical and welfare aspects as well as scientific or educational value;l2

Proposals must be considered and approved at meetings of the AEEc.l3

The AEEC may establish an executive (including at least one member from Category C or D> to

approve minor modifications to projects, and deal with emergencies, but any decisions by the executive must be reviewed by the AEEC at its next meeting.14 The executive may not approve proposals.l5

266

16.54 The above four clauses provide a clear direction to

ethics committees for the consideration and approval of

proposals. The current Code of Practice is unclear on this point and in many institutions advantage has been taken of this lack of clarity whereby protocols have been considered other than at meetings of an ethics committee.

16.55 Copies of protocols need to be distributed to members of an ethics committee prior to a Members may seek additional

meeting for their consideration. information or do their own

investigation of a protocol with which they have reservations. However, such preliminary consideration must not be a substitute for consideration at a meeting of the ethics committee. The

dynamics of a meeting facilitates the raising of issues and

encourages discussion. A point made by one member of a committee will often lead to a chain reaction in the thinking of other

members. It is the collective wisdom of a committee, with each

member bringing his or her own expertise or perspective to bear on the matter together with the other members, that enables a

judgement to be made.

16.56 Self-regulation, within or without a legislative

framework, requires both responsibility and public

accountability. The system of ethics committees provides the opportunity for there to be responsibility on the part of the

scientific community and also public accountability. Members representing the community or animal welfare will be, if not

already are, a way for community interests to be represented in decisions on the use of animals in experiments. The public

attitude towards animal experimentation is of tolerance provided that there is responsibility on the part of the scientific

community. The public recognises the benefits that have resulted from experiments on animals in the past and the prospect of

further benefits in the future. There is a growing feeling that such animal experiments must take place with the minimum number of animals with the least possible suffering. The use of ethics

267

committees with members reflecting scientific, veterinary, community and animal welfare interests, enables the public to have some confidence that the interests of the animals are being taken account of in a responsible way. The operations of an

ethics committee which do not provide the greatest possible

protection of the interests of the animals will, in the end,

breed suspicion of the system and bring it into disrepute.

16.57 The Committee acknowledges the benefits of an executive committee making minor modifications to an approved protocol and in making decisions in emergencies, both subject to review by the ethics committee. The executive committee cannot approve

protocols in any circumstances. This prohibits the practice being carried out in a few ·institutions where consideration and

approval of some or all proposals have been delegated to one or two members of an ethics committee.

16.58 The Committee supports the system of enforced

self-regulation based on ethics committees on the basis that ethics committees operate properly as committees and fully

consider and make decisions on protocols at meetings of those committees and not by correspondence or delegation to one or a few members of an ethics committee.

Guidelines

16.59 The Code of Practice sets out the principles for the

care and use of animals for experimental purposes and the

administrative procedures to be followed for the control and supervision of animal experimentation. It does not, however, give details of the care and use of specific species of animal. The

NHMRC foresaw the need to prepare and publish additional

guidelines to supplement the Code of Practice. There are various

268

and manuals available for scientific procedures done on some species and for the husbandry of those species. Not all

are up-to-date. Some species, especially Australian native wildlife, are not adequately covered.

16.60 The NHMRC has draft guidelines for use of native mammals in biomedical research and has prepared another set of guidelines for primates. The latter was regarded as totally inadequate by the Australian Primate Society.

16.61 There is a need to prepare guidelines on specific

species of animal to assist experimenters and animal house staff in their use and care. The Committee believes that ACCART is the most appropriate organisation to prepare guidelines in many areas of animal experimentation. It already has several monographs in

the process of publication. ACCART should liaise with other

specialist societies, including the NHMRC and its committees, in drawing up those guidelines. ACCART is more appropriate to

undertake this task than the NHMRC because it is a resource

centre whereas the NHMRC is primarily a government funding body.

16.62 The Committee RECOMMENDS that the Australian Council for the Care of Animals in Research and Teaching prepare guidelines on procedures and practices in relation to animal experimentation to supplement the Code of Practice.

269

Senator A.R. Devlin Chairman

REFERENCES

Chapter 1

1. Morgan Gallup Poll, The Bulletin, 28 February 1989

Chapter 2

1 . Evidence, p. 7432 .

2. CSIRO, Supplementary Information for the Senate Select Committee on Animal Welfare, 27 November 1985 .

Chapter 3

1. Andress-Holger Maehle & Ulric Tr6hler, 'Animal Experimentation from Antiquity to the End of the Ei ghteenth Century Attitudes and Arguments', in Vivisection in Historical Perspectives, ed by Nicolaas A. Rupke, Croom Helm, 1987, pp . 14-47

2 . Maehle & Tr6hler, pp. 26-27

3. R.G. Frey, Interests and Rights: The Case Against Animals, Claredon Press, 1980, pp. 30, 64, 167

4 . Genesis I: pp. 27-28

5 . J. Tannenbaum & A. Rowan, ' Rethinking the Morality of Animal Research.' Hastings Center Report, October 1985, p. 35

6. Evidence, p. 7375

7. Evidence, p. S6471

8. Evidence, p. S6471

9 . P. Singer, Animal Liberation, Avon Books, New York, 1978 , p. 8

1 0. T. Regan: All That Dwell Therein, University of California Press, Berkeley, 1982, p. 41

11. Regan, p. 47

12. Evidence, p. 1558

13 . Evidence, pp. 7734-5

271

14. Regan, pp. 93-4

15. Evidence, pp. S1184-5

16. Evidence, p. Sll83

17. H.J. McCloskey, 'Moral Rights and Animals', Inquiry, Vol.22, p. 51

18. McCloskey, p. 24

19. McCloskey, p. 25

20. Evidence, p. 7754

21. Evidence, p. Sll88

22. Evidence, p. S1189

23. Evidence, p. Sll89

24. Evidence, p. 315

25. Evidence, p . 316

26. Evidence, p. 7754

27. Evidence, p. 307

28. Evidence, p. S7017

29. L. Holbrow, 'Public Accountability and the Freedom of the Individual' in Animal Experimentation Ethical, Scientific and Legal Perspectives, University of New South Wales, July 1988, p. 133

30. A. Caplan, Animal Welfare: A Duty But Not a Right, paper

presented at the American Psychological Association Annual Meeting, Toronto, Ontario, Canada, 17 August 1984, p. 10

Chapter 4

1. Evidence, p. 7880

2. H. Merskey, 'Pain terms: a list with definitions and notes

on usage, Pain, 1979, Vol.6, pp. 249-252

3. B. Voorzanger & Tj de Cock Buning, EC Report on the

definitions of 'pain', 'stress' and 'suffering' and the use of these concepts in legislation on animal experiments, EC grant 6681-(86>08. Summer 1988, p. 51

272

4. R . Kitchell & H. Erickson, 'Introduction' in Animal Pain, Perception and Alleviation, eds Kitchell & Erickson, American Physiological Society, 1985, p. vii

5. E.M. Wright Jnr et al, 'Animal Pain: Evaluation and

Control', Lab Animal, May-June, 1985, pp. 20-21 6. Voorzanger & de Cock Buning, p . 55

7. Kitchell & Erickson, p. viii

8 . Evidence, pp. 7872-3

9. Evidence, p. 7971

10. Evidence, p. 7883

11. Evidence, p. 1527

12. Stamp Dawkins, Animal Suffering: The Science of Animal

Welfare, Chapman & Hall, 1980, p. 109

13. D.B. Morton & P.H . M. Griffiths, 'Guidelines on the recognition of pain, distress and discomfort in experimental animals and an hypothesis for assessment', in Veterinary Record, 20 April 1985, p. 431

14. D. Adams, 'An Approach to Pain in Research Animals', ATLA, Vol.16, 1988, p. 147

15. Evidence, p. 7970

16. Evidence, p. 7971

17. Evidence, p. 7903

18. Evidence, p. 7379

19. Evidence, p. 8506

20. Draft revised Code of Practice for the Care and Use of

Animals for Scientific Purposes, 22 February 1989, paragraph 2.2.32

21. P.A. Flecknell, 'The Relief of Pain in Laboratory Animals', Laboratory Animals, Vol.18, 1984, p. 147

22. P.A. Flecknell, 'Anaesthesia, Analgesia, and Pre and Postoperative Care', ANZFAS Submission, Vol.4, Appendix H, p . 7

23. Evidence, p. S6442

273

24. Code of Practice for the Care and Use of Animals for

Scientific Purposes, p. 2 25. Draft Code of Practice, paragraph 1.14

26. ANZFAS, Draft Code of Practice for the Care and Use of

Animals for Experimental Purposes, 22 September 1988, Comments prepared by the Australian and New Zealand Federation of Animal Societies, p. 2

27 . Evidence, p . 7 372-3

28. Evidence, p. 7463

Chapter 5

1. Evidence, p. S1234

2. Evidence, p. S6857

3 . Evidence, p. S6857

4. Evidence, p. 447

5. Evidence, p. 7481

6. Evidence, p. 6045

7. Evidence, p. 6498

8. Evidence, p. 8523

9. Evidence, p. 7848

10. Evidence, p. 7849

11. Evidence, p. 5285

12. w. Broad, & M. Wade, Betrayers of the Truth, OUP, 1982,

Chapter 5

13. Office of Technology Assessment, Alternatives to Animal Use in Research Testing and Education, u.s. Congress, February 1986, p. 7

14. Office of Technology Assessment, p. 7

15. Evidence, p. 7188

16. J.B. Dixon, 'Tissue Cultures: Do They Complement or Replace the Living Animal?', in Animal Experimentation: Improvements and Alternatives, eds Norman Marsh & Susan Haywood, FRAME, 1985, p. 63

274

1 7 . P.A. Flecknell 'Recognition and Alleviation of Pain in Animals', in Advances in Animal Welfare Science 1985, eds M.W. Fox & L.D. Mickley, Humane Society, p. 61

18. Evidence, p. 6340

19. Evidence, p. 6117

Chapter 6

1. D. MacDonald & M. Stamp Dawkins, 'Ethology- The Science and the Tool', in Animals in Researched . David Sperlinger , John Wiley & Sons, 1981, p. 208

2. University of Newcastle, letter to AVCC, 9 February 1988

3. University of Newcastle, letter to AVCC, 9 February 1988

4. Evidence, p. 7624

5 . Evidence, p. S7072

6 . Evidence, p. 7459

7. Evidence, p. S7075

8. Evidence, p. S7073

9. Evidence, p. 57073

10. Evidence, p. 57074

11. Evidence, p. 57074

12. D. Bannister, 'The Fallacy of Animal Experimentation in Psychology', in Animals in Research, ed. D. Sperlinger, 1981; M.A. Giannelli, 'Three Blind Mice, See How They Run: A Critique of Behavioural Research with Animals', in Advances on Animal Welfare Science 1985, eds by M.W. Fox & L.O. Mickley

13. Evidence, pp. 56502-3

14. A. Rowan, Of Mice, Models and Men, State University of New York Press, 1984, pp. 139-140

15. Evidence, pp. 7625-6

16. Evidence, p. 56491-2

17. Evidence, p. 56494-5

1 8 . Evidence, p. 56496

19. Evidence, p. 7805

275

Chapter 7

1. Office of Technology Assessment, p. 150

2. Office of Technology Assessment, p. 152

3. Evidence, pp. 58010-1

4. Evidence, pp. 8602-3

5. Evidence, p. 57897

6. Evidence, p. 518-9

7. Evidence, p. 57856

8. Evidence, p. 8593

9. Evidence, p. 58040

10. Evidence, p. S7997

11. Evidence, p. S6588

12. Evidence, p. S6589

13. Evidence, p. S6589

14. Evidence, p. S6589

15. Evidence, p. 8574

16. R. Heywood, 'Long Term Toxicity', in Animals and Alternatives in Toxicity Testing, eds M. Balls, R.J. Riddel, A.N. Worden, Academic Press, 1983, pp. 88-9

17. Evidence, p. S6590

18. Evidence, p. S6590

19. ATLA 14, No. 3, p. 184, quoted in Evidence, p. S6591

20 . Office of Technology Assessment, p. 177

21. Evidence, p. S8000

22. Evidence, p. S8041

23. Office of Technology Assessment, p. 183; A. Rowan, pp. 218-9

24. Evidence, p. 56630-1

25. A. Rowan, pp. 226-7

276

26. Office of Technology Assessment, p. 183

27 . Office of Technology Assessment, p. 183

28. J . Griffith, 'The Low- Volume Eye Irritation Test. A Case Study in Progress Toward Validation', Chemical Times and Trends. July 1987, p. 19722-38

29 . G. Zbinden, 'Acute Toxicity Testing, Public Responsibility and Scientific Challenges', in Benchmarks: Alternative Methods of Toxicology, ed M.A. Mehlman, Princeton Sc i entific Publishing, 1 989

30. British Toxicological Society Working Party on Toxicity, 'A New Approach to the Classification of Substances and Preparations on the Basis of their Acute Toxicity ' , Human Toxicology, 1984, Vol. 3, p. 88

31. A. Rowan, 'The Search for Alternatives', in Fundamental and Applied Toxicology, Vol. 4, 1984, p. 514

32. D. J. Brusick, 'The Use of Short Term In Vitro .and

Submammalian Tests As Alternatives to Large Scale Animal Bioassays', New York Academy of Sciences Proc., Vol . 406, 1983, p. 71

33. New York Academy of Sciences, p . 71

34. Department of Community Services and Health, letter, 17 February 1989

35. Evidence, p. S7094

36. CSIRO, Press Release, 15 August 1986

37 . NABR Update, Vol. 9, No. 22, 18 October 1988, p. 1

Chapter 8

1. CSIRO, Supplementa;ry Information for the Senate Select Committee on Animal Welfare, 27 November 1985, p . l

2 . Evidence, p. S1481

3. Evidence, p . S1485

4 . Evidence, P· S1487

s . Evidence, p. S1488

6. Evidence, p. S6491

7. Evidence, p. 7850

277

8. Evidence, p. S7603-4

9 . Evidence, p. S6503

10. Evidence, p. 7373

11. Evidence, p. S7603

12. Evidence, p. 7902

13 . C.M. Perrins, 'Field Experiments with Animals', in The Ethics of Experimentation on .Living Animals, papers prepared by Members of the Royal Society's Ethical Workin g Party on Animal Experimentation, p. 46

14. Perrins, p. 47

1 5 . Evidence, p. S7601

16 . Antarctic Science Advisory Committee, Report to the Minister for the Arts, Sport, the Environment, Tourism and Territories of the ASAC Working Group on Research Involving Animals in the Antarctic, Department of the Arts, Sport ,

the Environment, Tourism and Territories, 1988, p. 24

17. Antarctic Science Advisory Committee, p. 26

18. Antarctic Science Advisory Committee, p. 14

Chapter 9

1 . Evidence, pp. 6883, 6795

2. M. Rose, 'The Welfare of Animals in Research - is There a

Conflict?', pp. 3-4, ANZAAS Conference, 1982, n.p. 3 . Review of Animal House Services, The University of Adelaide, Adelaide, 1985, p. IV

4. Evidence, pp. 6047-8

5. Evidence, pp. S6444-5

6. G. Clough 'Environmental Factors in Relation to Comfort and Well-Being of Laboratory Rats and Mice', in Standards in Laboratory Animal Management, UFAW, 1984, pp. 17-24

7 . G. Clough, p. 22

8. M. Lawlor, The Effect of Caging Factors on the Growth and

Well-Being of Laboratory Rats: A Report to the UFAW Council, November 1987

278

9 . M. Rose, Biological Definition of Animals in Experimental Design, paper presented at seminar on 'Animal Experimentation Management: A Role for the Veterinary Profession, at the University of Melbourne, May 1987, p. 1

10. G. Lussier & J-P. Descoteaux, 'Prevalence of Natural Virus Infections in Laboratory Mice and Rats Used in Canada, Laboratory Animal Science, Vol. 36, No.· 2, April 1986, p. 145

11. Lussier & Descoteaux, p. 147

12 . M.F.W. Festing, 'Genetic Contamination of Laboratory Animal Colonies: an Increasingly Serious Problem', ILAR News, Volume XXV, Number 4, Summer 1982, pp. 6-9; & H.A. Hoffman, 'Profile of a Genetic Contamination: BALB/C-nu Mice', ILAR

News, Volume XXVII, Number 1, Fall 1983, pp . 10-11

1 3 . Evidence, p. 8055

14. Evidence, p. 8060

15 . Evidence, pp. 8475, 8477

16. Evidence, p. 8474

1 7 . Evidence, p. 7224

1 8 . Evidence, p. 8462

19 . ASLAS letter, 2 December 1988, and Evidence p. 8461

2 0 . Evidence, p. 7320

21 . Evidence, p. 8010

2 2 . University of Queensland, Central Animal Breeding House, Annual Report, 1st January-31.st December 1986, p. 2

23. Evidence, p. 8047

24. Evidence, p. 8052

25. Evidence, p . 7712

26 . Evidence, p. 7239

27. Review of Animal House Services, University of Adelaide, Adelaide, 1985, p. 52

28. Evidence, p. 54196

29. Evidence, p . S5961

279

30. Evidence, pp. S5676, S7716

31. Evidence, p. S5961

32. New York Academy of Sciences, Ad Hoc Committee on Animal Research, Interdisciplinary Principles and Guidelines for the Use of Animals in Research, Testing and Education, NYAS, New York, 1988, p. 3

Chapter 10

1. Evidence, p. 7958

2. Evidence, p . 7959

3. Evidence, p. 6892

4. Evidence, p. 7275

5. Evidence, pp. 7275-6

6 . Evidence, p. 6886 and pp. 7278-9

7. Evidence, pp. 7959, 7932

8. Evidence, p . 6874

9. Evidence, p. 7934

10. Evidence, p. 6699

11. Evidence, p. 6108

12. Evidence, p. 7905

13. Evidence, p. 7905

14. Evidence, p. S6513

15. Evidence, p. S6513

Chapter 11

1. Animal Care Review Report, - 9 May 1983

2. Evidence, p. 6797

3. Evidence, pp. 6803-4

4. Evidence, p. 6807

5. Evidence, pp. S5391-2

280

6. Evidence, p. S5391

7 . Evidence, p. 6793, pp. 8469-70

8 . Evidence, pp. 8468-9

9 . Evidence, p. 8469

1 0 . Evidence, p. 7633

11. Evidence, p. 8463

Chapter 12

1. Evidence, pp. S7263 - 4

2 . Evidence, p. S7264

3. Canadian Council on Animal Care, Syllabus for a Course i n the Basic Principles of Laboratory Animal Science for Research Scientists, Technicians and Other Support Personnel, CCAC, Ottawa, 1983, p. 1

4. Evidence, p. S8027

5. Evidence p. 8029

6 . Evidence, pp. S4329-33

7 . Report of the Working Party on Courses for Animal Licensees, Laboratory Animals 18, 1984, pp . 209-220

8 . Evidence, p. 6995

9. Evidence, p. 7966

1 0 . Evidence, p. S5692

11. Evidence, p. S8067

Chapter 13

1 . Evidence, p. S258

2. Evidence, pp . S1568-9

3 . Evidence, p. S1569

281

Chapter 14

1. Evidence, pp. 57144-5

2. Animal Research Act 1985, s.14<1>

3. Evidence, p. 57146; Animal Research Act 1985, s.9

4. South Australian House of Assembly Debates, 9 October 1985, p. 1224

Chapter 15

1. Evidence, p. 56553

2. Evidence, p. 56555

3. Evidence, p. 56556

4. Evidence, p. 55300

5. Evidence, pp. 55301-2

6. Evidence, p. 6058

7. Evidence, p. 57510

8. Evidence, pp. 58072-81

9. Evidence, p. 57189

10. Evidence, p. S8097

11. Evidence, p. 58097

Chapter 16

1. Evidence, p. 53722

2. Evidence, p. 5286

3. Evidence, p. 6541A

4. Evidence, p. S3746

5. Evidence, p. 5276

6. Evidence, p. 5275

7. Draft Code of Practice, paragraph 2.2.27

282

8. Draft Code of Practice, paragraph, 2.14

9 . Draft Code of Practice, paragraph 2.2.28

10. Draft Code of Practice, paragraph 2.2.2

11. Evidence, p. 7471

1 2. Code of Practice, Section 1.1c

13. Draft Code of Practice, Section 2 . 2. 2 (iii)

1 4. Draft Code of Practice, Section 2.2.17

15. Draft Code of Practice, Section 2.2.11

16. Draft Code of Practice, Section 2.2.12

283

APPENDIX I

LIST OF WITNESSES WHO APPEARED BEFORE THE COMMITTEE TO GIVE EVIDENCE ON ANIMAL EXPERIMENTATION

Adams, Mr J., Director, Animal Services, Monash University, Clayton, Victoria Adams, Mr J . , Selby, Victoria Ahlston, Ms E., President, Australian Association for Humane

Research, Broadway, New South Wales Aitkin, Dr L., Monash University, Clayton, Victoria Alexander, Dr G., President, Australian Federation for the Welfare of Animals Inc., Division of Animal Production, Ian

Clunies Ross Animal Research Laboratory, Blacktown, New South Wales Anderson, Dr W.P., Chairman, Animal Experimentation Ethics Committee, National Health and Medical Research Council,

Canberra, Australian Capital Territory Barber, Mr P., Director, RSPCA Victoria, Burwood, Victoria Barnes, Mr D.,Australian and New Zealand Federation of Animal Societies, Collingwood, Victoria Beazley, Dr L.D., Senior Research Fellow, Department of

Psychology, University of Western Australia, Nedlands, Western Australia Blackshaw, Dr A.W., Head, Department of Physiology and Pharmacology, University of Queensland, St Lucia, Queensland Blackshaw, Dr J . K., Lecturer in Animal Behaviour, Department of

Animal Sciences and Production, University of Queensland, St Lucia, Queensland Boardman, Dr N.K., Member of Executive, CSIRO, Dickson, Australian Capital Territory Bond, Professor N.W., Associate Professor, School of Behavioural

Sciences, and Member, Animal Experimentation Ethics Committee, Macquarie University, Sydney, New South Wales Bond, Dr N.W., School of Behavioural Sciences, Macquarie University, North Ryde, New South Wales Bareham, Dr P.F.L., Principal Research Fellow, Queensland

Institute of Medical Research, Herston, Queensland Boura, Professor A.L.A., Chairman, Department of Pharmacology, Monash University, Clayton, Victoria Boura, Professor A.L.A., Member, Australian Federation for the

Welfare of Animals

University of Western Australia, Nedlands, Western Australia Bruce, Dr N.W., Associate Professor, Department of Anatomy and Human Biology, University of Western Australia, Nedlands, Western Australia Burman, Mr S.L., Member, Australian Federation for the Welfare of

Animals Inc., Blacktown, New South Wales

285

Burns, Mr J . P., Secretary, Animal Ethics Committee, University o f Tasmania, Hobart, Tasmania Bushell, Dr G.R., Senior Scientific Officer, Queensland Institute of Medical Research, Herston, Queensland Campbell, Dr I., Director, Australian Society for Medical

Research, Sydney, New South Wales Carryer, Miss S.E., Administrator, WA Group Against Vivisection

Parkville, Victoria Chenoweth, Deputy Dean, Clinical, School of Veterinary Science, University of Queensland, St Lucia, Queensland Clark, Professor W.T., Professor of Small Animal Medicine and

Surgery, Murdoch University, Murdoch, Western Australia Clarke, Mrs P., President, Animal Liberation Tasmania Inc., Hobart, Tasmania Coleman, Dr G.J . , Chairman, Department of Psychology, LaTrobe

University, Bundoora, Victoria Collins, Dr T.P., Vice-President, Australian Veterinary Association, Sydney, New South Wales Cooper, Professor D.W., School of Biological Sciences, and

Chairman, Animal Experimentation Ethics Committee, Macquarie University, Sydney, New South Wales Cotton, Dr W.G., Ethical Animal Research Information Group, Animal Care, Westmead Centre, Westmead, New South Wales Cotton, Dr W.G., Director of Animal Houses, University of Sydney,

Sydney, New South Wales Crossing, Dr R.J., Acting Principal Veterinary Officer, Bureau of Animal Welfare, Department of Agriculture and Rural Affairs, East Melbourne, Victoria Cumming, Dr R.W., Secretary, National Health and Medical Research

Council, Canberra, Australian Capital Territory Curtis, Professor D., Department of Pharmacology, John Curtin School of Medical Research, Canberra, Australian Capital Territory Curtis, Professor D.R., Member, Sub-Committee on Animal

Experimentation, Australian Vice-Chancellors' Committee, Braddon, Australian Capital Territory Daly, Mr D., Australian Council on the Care of Animals in Research and Teaching Dalziel, Dr F., Senior Lecturer in Psychology, University of

Adelaide, North Terrace, Adelaide, South Australia Darian-Smith, Professor I., Professor of Anatomy, University of Melbourne, Parkville, Victoria Darian-Smith, Professor I., National Health and Medical Research

Council, Canberra, Australian Capital Territory Davison, Mrs S.P., Secretary, National Council, Australian Animal Technicians Association, Brisbane, Queensland Dawson, Professor T.J., Faculty of Biological and Behavioural

Sciences, University of New South Wales, Kensington, New South Wales De Cean, Department of Community Services and Health, Canberra, Australian Capital Territory

286

Deeny, Mr A.A., Director, Animal Resources Centre, Willetton, Western Australia Dickson, Mr R.W., Member, National Council, Australian Animal Technicians Association, Brisbane, Queensland Doherty, Professor R.L., Pro-Vice-Chancellor, Health Sciences,

University of Queensland, St Lucia, . Queensland Donald, Dr A.D., Chief, Division of Animal Health, CSIRO, Glebe, New South Wales Dorsch, Professor S.E., Pro-Vice-Chancellor, University of

Sydney, Sydney, New South Wales Dowsett, Dr J., Director of Teaching and Research, Resources and Chairman, Animal Care Committee, Parramatta Hospitals, Westmead Centre, Westmead, New South Wales Dunlevy, Mr J.M.M., President, W.A. Group Against Vivisection,

Perth, Western Australia Eadie, Professor M.J., Chairman, Ethics Committee, Queensland Institute of Medical Research, Herston, Queensland Edwards, Dr T., Animal Studies, Bentley College of TAFE, Hayman

Road, Bentley, Western Australia Egan, A.R., Professor of Agriculture and Forestry,

University of Melbourne, Parkville, Victoria Egerton, Professor J.R., Chairman, Animal Welfare Aqvisory Council, Department of Local Government, Sydney, New South Wales Fell, Dr L.R., Australian Federation for the Welfare of Animals

Inc., Blacktown, New South Wales ·

Fenwick, Mr D.C., Chief Scientific Officer, Department of Physiology and Pharmacology, University of Queensland, St Lucia, Queensland Fisher, Mr B.P., Vice-President, Animal Liberation Ltd.,

Brisbane, Queensland Gleeson, Dr P.J., Executive Officer, Animal Experimentation Ethics Committee, La Trobe University, Bundoora, Victoria Graham, Dr D., National Biological Standards Laboratory

Hampson, Dr J.E., Consultant, Australian and New Zealand Federation of Animal Societies, Collingwood, Victoria Harris, Mr I.E., Acting Director, Central Animal Breeding House, University of Queensland, St Lucia, Queensland Harris, Mr I.E., Member, National Council, Australian Animal

Technicians Association, Brisbane, Queensland Healy, Mr T.J., CSIRO, Campbell, Australian Capital Territory Hellyer, Dr o., Cosmetic, Toiletries and Fragrance Association of Australia, North Sydney, New South Wales Howell, Professor J.M., School of Veterinary Studies, Murdoch

University, Murdoch, Western Australia Imray, Dr P., Department of Community Services and Health, Canberra, Australian Capital Territory Jackson, Dr A., Executive Officer, Standing Committee on Ethics

in Animal Experimentation, Monash University, Clayton, Victoria Jackson, Professor D., University of Sydney, Sydney, New South Wales Jackson, Dr G.D.F., Associate Professor, School of Microbiology,

University of New South Wales, Kensington, New South Wales

287

Jacobs, Mr D., Curator, Animal House, University of Tasmania, Hobart, Tasmania Janssens, Dr P.A., Australian National University, Canberra, Australian Capital Territory Jeffrey, Dr P.L., Principal Research Fellow, Childrens Medical

Research Foundation, Camperdown, New South Wales Jenkin, Dr G., Councillor, Australian Federation for the Welfare of Animals Inc., Blacktown, New South Wales Johnson, Dr K.G., Senior Lecturer in Physiology, Murdoch

University, Western Australia Jones, Mr M.R ; , Honorary Secretary, Animal Liberation , Inglewood, Western Australia Jones, Mr W.L . , Inspector, RSPCA Tasmania, Rosney Park, Tasmania Kehoe, Dr E.J., Senior Lecturer, School of Psychology, Faculty of

Biological and Behavioural Sciences, University of New South Wales, Kensington, New South Wales Kehoe, Dr E.J., Australian Psychological Society, National Science Centre, Parkville, Victoria Kelly, Dr G.E . , Ethical Animal Research Information Group, Animal

Care, Westmead Centre, Westmead, New South Wales King, Professor M.G., Member, Australian Federation for the Welfare of Animals Inc., Blacktown, New South Wales Kuchel, Dr T., Australian Society for Laboratory Animal Science Large, Mrs A., Manager, Animal Welfare Branch, Department of

Local Government, Sydney, New South Wales Lawrence, Dr G.W., Senior Research Fellow, Queensland Institute of Medical Research, Herston, Queensland Lazenby, Professor A., Australian Council on the Care of Animals

in Research and Teaching Lazenby, Professor A., Australian Vice-Chancellors Committee Lindsay, Professor D.R., Chairman, Animal Welfare Committee, University of Western Australia, Nedlands, Western Australia Logan, Professor M., Deputy Vice-Chancellor, Monash University,

Clayton, Victoria Lovibond, Dr P.F., Member, Australian Psychological Society, National Science Centre, Parkville, Victoria Lowther, Professor P., Chairman, Animal Services Committee,

Monash University, Clayton, Victoria Lumbers, Professor E.R., School of Physiology and Pharmacology, Medical Faculty, University of New South Wales, Kensington, New South Wales Lykke, Professor A.W.J., Chairman, Animal Ethics Committee,

University of New South Wales, Kensington, New South Wales Macey, Dr D.J., Lecturer in Biology and Animal Physiology, Murdoch University, Western Australia Martin, Dr A.A., Chairman, Department of Zoology, University of

Melbourne, Parkville, Victoria Martin, Professor R., Chairman, Sub-Committee on Animal Experimentation, Australian Vice-Chancellors' Committee,

Braddon, Australian Capital Territory Martin, Dr T., Director of Animal Care, University of New South Wales, Kensington, New South Wales McColm, Ms S., Animal Welfare Officer, Registrar's Office,

University of Western Australia, Nedlands, Western Australia

288

McKie, Mr D.G., Secretary, Committee on Ethical Use of Animals for Experimentatal Purposes, University of Adelaide, North Terrace, Adelaide, South Australia Mc Neil, Mr A., Officer in Charge, Central Animal House,

University of Adelaide, North Terrace, Adelaide, South Australia Manley, Dr s.w.w., Senior Lecturer, Department of Physiology and Pharmacology, University of Queensland, St Lucia, Queensland Meischke, Dr R., RSPCA Australia, Fyshwick, Australian Capital

Territory Me rkelbach, Mr P., Director of Animal Care, Westmead Centre, Westmead, New South Wales Muller, Professor H., Head of Pathology, University of Tasmania,

Hobart, Tasmania Nelson, Dr D.S., Councillor, Australian Federation for the Welfare of Animals Inc., Blacktown, New South Wales Nelson, Dr J., Senior Lecturer, Zoology Department, Monash

University, Clayton, Victoria Newman-Martin, Mr G., Principal Chemist, Toxicology Section, Department of Community Services and Health, Canberra, Australian Capital Territory O'Donovan, Professor J., Member, Animal Welfare Committee,

University of Western Australia, Nedlands, Western Australia Parish, Dr C.R., Australian National University, Canberra, Australian Capital Territory Pinder, Ms E., Australian Association for Humane Research,

Darlinghurst, New South Wales Porter, Professor R., Director, John Curtin School of Medical Research, Canberra, Australia Capital Territory Porter, Professor R., Member, National Health and Medical

Research Council, Canberra, Australian Capital Territory Priestley, Dr B., Senior Lecturer, Pharmacology, University of Adelaide, North Terrace, Adelaide, South Australia Purcell, Dr D.A., Chief Veterinary Pathologist, Animal Health

Laboratories, Western Australian Department of Agriculture, South Perth, Western Australia Reilly, Dr J., Animal Welfare Officer, Faculty of Veterinary Science, University of Queensland, St Lucia, Queensland Reilly, Dr J., Animal Welfare Officer, Queensland, Institute of

Medical Research, Herston, Queensland Rex, Professor M.A.E., Chairman, Animal Experimentation Ethics Committee, University of Queensland, St Lucia, Queensland Reynoldson, Dr J.A., Senior Lecuter in Pharmacology and

Chemotherapy, Murdoch University, Murdoch, Western Australia Rijswijk, Mr G. van, Agricultural and Veterinary Chemicals Association, North Sydney, New South Wales Roach, Mr B.E., Supervising Senior Health Surveyor, Logan City

Council, Woodridge, Queensland Roberts, Mrs I.P., Committee Member, Australian Association for Humane Research, Darlinghurst, New South Wales Ronayne, Professor J., Deputy Vice-Chancellor, Administration,

University of New South Wales, Kensington, New South Wales Rose, Dr M.A., Ethical Animal Research Information Group, Animal Care, Westmead Centre, Westmead, New South Wales

289

Rose, Dr M.A., Chairman, Animal Research Review Panel, Department of Local Government, Sydney, New South Wales Rose, Dr M.A., Member, Sub-Committee on Animal Experimentation, Australian Vice-Chancellors Committee, Braddon, Australian

Capital Territory ·

Rowe, Professor M.J., Associate Professor, School of Physiology and Pharmacology, Medical Faculty, University of New South Wales, Kensington, New South Wales Rowe, Professor P.B., Director, Childrens Medical Research

Foundation, Camperdown, New South Wales Runciman, Dr w., Senior Lecturer, Intensive Care Unit, Flinders Medical Centre, Bedford Park, South Australia Ryder, Mr R.D.,Australian and New Zealand Federation of Animal

Societies, Collingwood, Victoria Scott, Dr L., Animal Welfare Officer, University of Melbourne, Parkville, Victoria Scott, Dr L., Australian Society for Laboratory Animal Science Setchell, Professor B., University of Adelaide, North Terrace,

Adelaide, South Australia Shackleford, Mr and Mrs R.M., Emerald, Victoria Sheldon, Dr B., Federation for the Welfare of Animals Inc., Blacktown, New South Wales Shellam, Professor G.R., Professor of Microbiology, University of

Western Australia, Nedlands, Western Australia Siddle, Dr D.A.T., Associate Professor in Psychology, Australian Psychological Society, Macquarie University, North Ryde, New South Wales Sim, Mr J.P., Member of Senate, Murdoch University, Murdoch,

Western Australia Singer, Professor P.,Vice-President, Australian and New Zealand Federation of Animal Societies, Collingwood, Victoria Smith, Dr J., Animal Welfare Officer, Australian National

University, Canberra, Australian Capital Territory Smith, Dr J., Australian Society for Laboratory Animal Science Smith, Dr J.B., Member, Board of Management, Australian Veterinary Association, Sydney, New South Wales Stacey, Mr A.H., State President, RSPCA Tasmania, Launceston,

Tasmania Stone, Ms M., Senior Lecturer, Faculty of Law, University of New South Wales, Kensington, New South Wales Stuart, Dr M.C., Member, Institution's Representative, Australian

Federation for the Welfare of Animals Inc., Blacktown, New South Wales Taylor, Dr I.W., Scientific Manager, Queensland Institute of Medical Research, Herston, Queensland Taylor, Professor M.G., Deputy Vice-Chancellor, University of

Sydney, Sydney, New South Wales Ternai, Dr B., Chairman, Animal Experimentation Ethics Committee, La Trobe University, Bundoora, Victoria Titchen, Professor D.A., Professor of Veterinary Physiology,

University of Sydney, Sydney, New South Wales Toia, Dr J., Chairman, National Council, Australian Animal Technicians' Association, South Brisbane, Queensland

290

Trent, Mrs J.K., Executive Officer, Northern Tasmanian Division, RSPCA Tasmania, Launceston, Tasmania Vaughan, Mrs A., Australian National University, Canberra, Australian Capital Territory Wackett, Mr M.S., Senior Administrative Officer, Research and

Postgraduate Studies, Murdoch University, Murdoch, Western Australia Watts, Mr D., Senior Project Officer, Animal Welfare Office, Department of Lands, Adelaide, South Australia White, Dr R.W., Senior Lecturer in Zoology, University of

Tasmania, Hobart, Tasmania Wiskich, Dr J., Chairman, Executive Committee, University of Adelaide, North Terrace, Adelaide, South Australia Withell, Mr J., National Biological Standards Laboratory,

Canberra, Australian Capital Territory Worth, Dr H., President, RSPCA Victoria, Burwood, Victoria Wright, Mr c., RSPCA Australia, Fyshwick, Australian Capital Territory

Young, Dr I., Department of Physiology, Monash University, Clayton, Victoria Yuncken, Mr T.F., Member, Animal Experimentation Ethics Committee, University of Melbourne, Parkville, Victoria

291

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