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

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Laboratory Animal Law: Legal Control of the Use of Animals in Research 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 Blackwell Publishing editorial offices: Blackwell Publishing Ltd, 9600 Garsington Road, Oxford OX4 2DQ, UK Tel: +44 (0)1865 776868 Blackwell Publishing Professional, 2121 State Avenue, Ames, Iowa 50014-8300, USA Tel: +1 515 292 0140 Blackwell Publishing Asia Pty Ltd, 550 Swanston Street, Carlton, Victoria 3053, Australia Tel: +61 (0)3 8359 1011 The right of the Author to be identified as the Author of this Work has been asserted in accordance with the Copyright, Designs and Patents Act 1988. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by the UK Copyright, Designs and Patents Act 1988, without the prior permission of the publisher. 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 Set in 11/13 pt Bembo by Graphicraft Limited, Hong Kong Printed and bound in Singapore by Fabulous Printers Pte Ltd The publisher’s policy is to use permanent paper from mills that operate a sustainable forestry policy, and which has been manufactured from pulp processed using acid-free and elementary chlorine-free practices. Furthermore, the publisher ensures that the text paper and cover board used have met acceptable environmental accreditation standards. For further information on Blackwell Publishing, visit our website: www.blackwellpublishing.com 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.
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