Laboratory Animal Law: Legal Control of the Use of Animals in Research

242 Pages·2007·0.72 MB·English

by  Kevin Dolan

Laboratory Animal Law:
Legal Control of the Use of
Animals in Research
Second Edition
Kevin Dolan
SThL(JusCan), BD, DipLaw, FIAT

Laboratory Animal Law:
Legal Control of the Use of
Animals in Research
Second Edition
Kevin Dolan
SThL(JusCan), BD, DipLaw, FIAT
© 2007 by Blackwell Publishing Ltd
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First edition published 2000 by Blackwell Science Ltd
Second edition published 2007 by Blackwell Publishing Ltd
ISBN: 978-1-4051-6282-1
Library of Congress Cataloging-in-Publication Data
Dolan, Kevin.
Laboratory animal law : legal control of the use of animals in
research / Kevin Dolan. — 2nd ed.
p. ; cm.
Includes bibliographical references and index.
ISBN: 978-1-4051-6282-1 (pbk. : alk. paper)
1. Laboratory animals—Law and legislation—Great Britain. 2. Animal
experimentation—Law and legislation—Great Britain. I. Title.
[DNLM: 1. Animal Experimentation—legislation & jurisprudence—Great
Britain. 2. Animals, Laboratory—Great Britain.QY 33 FA1 D659L 2007]
KD3426.D65 2007
344.4104′9—dc22
2006035498
A catalogue record for this title is available from the British Library
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Contents
Preface iv
Acknowledgements vi
Abbreviations vii
Part I Introduction 1
1 The Legal Protection of Animals 3
Part II The Animals (Scientific Procedures) Act 1986 – A(SP)A 9
2 The Coming of the Law on Laboratory Animals 11
3 The Protected Animal 22
4 The Regulated Procedure 24
5 Schedule 1 of the A(SP)A 28
6 The Personal Licence 34
7 The Project Licence 41
8 Training of Those with Responsibilities Under the A(SP)A 62
9 Certificates of Designation 67
10 Codes of Practice 90
11 The Re-use of Animals 95
12 Records, Returns and Reports 97
13 Offences, Penalties, Prosecutions and Peripheral Litigation 104
14 Officials and Committees 123
Part III Other Relevant Legislation 135
15 The Law on Veterinary Surgery 137
16 Drugs in Research 142
17 Liability in the Animal Unit 145
18 Ecological Aspects of Animal Legislation 156
19 Regulations Relevant to Animals in Research and
the Impact of European Legislation 163
20 Animal Welfare in Law 172
21 Legal Aspects of the Transport of Animals 182
22 Law on the Import and Export of Animals 190
Standard Conditions 199
Useful Addresses 210
Bibliography 215
Table of Cases 219
Table of Statutes 220
Table of Statutory Instruments 222
Table of European Legislation 224
Index 227
Preface
This book, Laboratory Animal Law: Legal Control of the Use of Animals in Research,
is intended to replace my previous work on this topic, Laboratory Animal Law(2000).
This is not merely a second edition of the previous book on the Animals (Scientific
Procedures) Act 1986 [A(SP)A]. The A(SP)A has not changed in the intervening
six years, but the impact of the Home Office (HO) on the administration of the
Act has increased as the years have rolled by since 1986. The influence in prac-
tice of the Inspectorate needs to be more and more taken into consideration if
one is to properly understand the legal control of the use of animals in research
in practice, at the level of the animal facility or in the implementation of the
project licence.
The welfare of laboratory animals is demanded by legislation and is, I hope,
adequately dealt with in the text. This is by no means intended to be a treatise
on animal law in general. It has been written primarily for the use of those involved
in animal studies, especially those concerned with animals in research. It is hoped
that it will give them an overall view of their legal obligations towards the animals
in their care. The public I have in mind is based on the numerous and various
animal technicians who have faced me in class during a period of more than
20 years. If the tone, therefore, tends to be lay rather than legal, it will show that
I have learnt more from them, perhaps, than they from me. I am fully aware that
the material in this book is available elsewhere, particularly on the internet. This
text is intended to provide a useful compilation of legal material of interest to
busy, non-legal-minded scientists and technicians in research using animals and may
be of value to concerned members of the public.
The main emphasis in the text will obviously be on the Animals (Scientific
Procedures) Act 1986 (referred to throughout the text as the A(SP)A). Other
legislation, such as the Animal Welfare Act, the Veterinary Surgeons Act 1966,
the Agriculture (Miscellaneous Provisions) Act 1968, the Animal Health Act 1981
and the European Directive 86/609/EEC, will be commented upon in so far as
they may be relevant to laboratory animals. The impact of European law on this
area of legislation will be noted. Passing reference will be made to some animal
laws, such as the Wildlife and Countryside Act 1981, which are peripheral to the
main theme of the book.
Numerous Statutory Instruments, both Orders and Regulations, along with
Directives, Codes of Practice, Guidelines and the Stipulations of Good Laboratory
Practice bearing on animal experimentation could be of interest to many scientists
and technicians dealing with animals and are often very relevant to their par-
ticular area of work. Unfortunately both space and time are limited. Where
appropriate I will refer to such documents and attempt to indicate the best place
to find them, particularly on websites. There is a list of relevant websites at the
end of the text.
Preface v
In such specialised areas there is the obvious need to consult the actual docu-
ments themselves. Their details would be difficult to paraphrase in a work such as
this. Furthermore, it must be stressed that where there are actual legal problems
or disputes of a litigious nature, the appropriate legal experts must be consulted if
an authoritative solution is being sought.
Kevin Dolan
Acknowledgements
The order in which the material is presented corresponds with my own past
lectures aligned to the Institute of Animal Technology’s syllabus for the Fellowship
Examination. Gratitude for the moulding of this text is due to the many students
who listened patiently and sometimes spurred me on. Joanna Cruden, Steve Cubit,
Lorraine Gagen, Jessica Gruninger and Jackie Taylor spring readily to mind. Thank
you also to those who have encouraged me along the way. Steve Barnet, Pilar
Browne, John Gregory, Janice Lobb, Peter McLoughlin and Ron Raymond
certainly fall into this category.
As a member of both the IAT and the LASA, I have drawn copiously from the
periodicals and publications emanating from those informative and prolific sources
of relevant material. I was particularly grateful to Phil Ruddock, editor of the IAT
Bulletin, for up-to-date material.
The Research Defence Society generously made available to me a large amount
of useful source material, which I would like to acknowledge with gratitude. The
Society stands out as a positive, outspoken force in the controversy surrounding
biological research.
Without fruitful consultation with the Home Office Inspectorate, along with
their ready supply of relevant material, this book would not have been possible.
The material taken from the Home Office Guidance Notes and from some DEFRA
publications is Crown copyright and reproduced with permission of the Controller
of Her Majesty’s Stationery Office. DEFRA’s material, particularly the website,
proved a useful source for material especially in Chapters 18 to 22.
Special acknowledgements must be paid to those friends who collaborated with
me in the production of this text. New material on animal welfare and the import
and export of animals was contributed by Jas Barley. New material on the role
of the NACWO and the codes of practice was contributed by Tim Betts. New
material on drugs in research was contributed by Pat Coulson. New material on
the NVS and Veterinary Surgeons Act was contributed by Fraser Darling. New
material on animal transport was contributed by Roger Francis. The secretarial
burden was ably shouldered and skilfully manipulated on her computer by Lerena
Dyer with the able assistance of Lovern Dyer. I was helped in my own IT ventures
in the writing of the book by Pat Barker. Thank you one and all.
Abbreviations
APC Animals Procedure Committee
A(SP)A Animals (Scientific Procedures) Act 1986
BUAV British Union for the Abolition of Vivisection
CD Certificate of Designation
CH Certificate Holder
CITES Convention on International Trade in Endangered Species
COSHH Control of Substances Hazardous to Health
DE Designated Establishment
DEFRA Department for the Environment, Food and Rural Affairs
ECVAM European Centre for the Validation of Alternative Methods
GLP Good Laboratory Practice
GUIDANCE Home Office Guidance (on the operation of the A(SP)A)
HO Home Office
HOI Home Office Inspector
IAT Institute of Animal Technology
LASA Laboratory Animal Science Association
LAVA Laboratory Animal Veterinary Association
LERP or ERP Local Ethical Review Process
MAFF Ministry of Agriculture, Fisheries and Food (cf. DEFRA)
NACWO Named Animal Care and Welfare Officer
NAVS National Anti-vivisection Society
NVS Named Veterinary Surgeon
OJ Official Journal of the European Community
PCD Home Office Documents to Certificate Holders
PIL Personal Licence
PODE Place other than a Designated Establishment
PPL Project Licence
RIDDOR Reporting of Injuries, Diseases and Dangerous Occurrences
Regulations
SI Statutory Instrument
SOP Standing Operating Procedure
RDS Research Defence Society
3Rs Replacement, Reduction and Refinement
UFAW Universities Federation for Animal Welfare
The acronym MAFF featured frequently in the first edition. It should be noted
that the Department for Environment, Food and Rural Affairs (DEFRA) was
created in June 2001 from the Ministry of Agriculture, Fisheries and Food and
from the environmental and countryside business areas of the then Department of
the Environment, Transport and the Regions. It has not always been therefore a
viii Abbreviations
simple case of substituting DEFRA for MAFF or DETR. Some material used comes
from the past, is still valid, and drew its legal support from MAFF or DETR. Thus
in some circumstances one of those acronyms is an appropriate reference and may
still occur. (cf. http://www.defra.gov.uk/corporate/index.asp).
In connection with some of the above arcane terms, I think that an anticip-
atory apology may not be out of place. In any subject, but particularly in law,
there is a tendency to become immersed in the associated jargon. Often we are
so familiar with our own technical expressions, whose meanings seem so obvious
to ourselves, that we tend to forget that to the outsider they may have an air of
mystery about them.
This was brought home to me after lecturing for four hours on the A(SP)A.
A Swiss scientist in Oxford expressed her appreciation of the instructive session.
She ensured me that she had understood all that was said except one recurring
phrase: ‘Home Office’. She knew what ‘home’ meant and what ‘office’ meant.
She could not comprehend what was the relevance of either term to laboratory
animals. The fact that the title of Secretary of State applies to politicians as diverse as
a Foreign Minister and the member of the government responsible for Northern
Ireland, confused the matter further. In this book ‘Secretary of State’ refers to one
of Her Majesty’s Principal Secretaries of State, ‘Secretary of State for the Home
Department’, popularly known as the Home Secretary. At the time of writing (2006)
he is the Rt. Hon. John Reid. ‘Home Office’ is the familiar title of the part of
government that deals with the various internal affairs of our nation.