Laboratory Animals. Regulations and Recommendations for Global Collaborative Research

401 Pages·2014·2.844 MB·English

by  Javier Guillen (Eds.)

Laboratory Animals
Regulations and Recommendations for
Global Collaborative Research
Javier Guillén
Senior Director and Director of European Activities
AAALAC International, Pamplona, Spain
AMSTERDAM • BOSTON • HEIDELBERG • LONDON
NEW YORK • OXFORD • PARIS • SAN DIEGO
SAN FRANCISCO • SINGAPORE • SYDNEY • TOKYO
Academic Press is an Imprint of Elsevier
Academic Press is an imprint of Elsevier
525 B Street, Suite 1800, San Diego, CA 92101-4495, USA
32 Jamestown Road, London NW1 7BY, UK
225 Wyman Street, Waltham, MA 02451, USA
Copyright © 2014 Elsevier Inc. 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
without the prior written permission of the publisher.
Permissions may be sought directly from Elsevier’s Science & Technology Rights,
Department in Oxford, UK: phone (+44) (0) 1865 843830; fax (+44) (0) 1865 853333;
email: [email protected]. Alternatively, visit the Science and Technology Books
website at www.elsevierdirect.com/rights for further information.
Notice
No responsibility is assumed by the publisher for any injury and/or damage to persons,
or property as a matter of products liability, negligence or otherwise, or from any use or,
operation of any methods, products, instructions or ideas contained in the material herein.
Because of rapid advances in the medical sciences, in particular, independent verification
of diagnoses and drug dosages should be made.
British Library Cataloguing-in-Publication Data
A catalogue record for this book is available from the British Library
Library of Congress Cataloging-in-Publication Data
A catalog record for this book is available from the Library of Congress
ISBN: 978-0-12-397856-1
For information on all Academic Press publications
visit our website at elsevierdirect.com
Typeset by TNQ Books and Journals
www.tnq.co.in
Printed and bound in United States of America
14 15 16 17 18 10 9 8 7 6 5 4 3 2 1
Contributors
Juan Manuel Baamonde Centro de Estudios Científicos (CECs), Valdivia, Chile
Michael Baar Canadian Council on Animal Care, Ottawa, ON, Canada
Kathryn Bayne AAALAC International, Frederick, MD, USA
B. Taylor Bennett National Association for Biomedical Research, Washington,
DC, USA
Ekaterina Akimovna Botovchenco Rivera Federal University of Goias, Brazil
John F. Bradfield AAALAC International, Frederick, MD, USA
Cecilia Carbone Facultad de Ciencias Veterinarias, Universidad Nacional de La
Plata, La Plata, Buenos Aires, Argentina
Pradon Chatikavanij National Research Council of Thailand (NRCT), Bangkok,
Thailand
Yvette Chen The University of Melbourne, Australia
Margaret E. Cooper Faculty of Veterinary Medicine, University of Nairobi, Kenya;
and DICE, The University of Kent; and Wildlife Health Services, UK
Anne-Dominique Degryse Pierre-Fabre, Service de Zootechnie, Institute de
Recherche Pierre-Fabre, Castres, France
Idle O. Farah National Museums of Kenya, Nairobi, Kenya
Yacov Fischer Israeli Council for Animal Experimentation; and Ministry of Health,
Jerusalem, Israel
Montip Gettayacamin AAALAC International, Samutprakarn, Thailand
Cynthia S. Gillett University of Minnesota, Minneapolis, MN, USA
Rafael Hernandez Gonzalez National Institute for Medical Science and
Nutrition-SZ, Animal Resources Department, Mexico City, Mexico
Richard Grant SNBL (Cambodia) Ltd, Khan Daun Penh, Phnom Penh, Cambodia
Gilly Griffin Canadian Council on Animal Care, Ottawa, ON, Canada
Faisal A. Guhad Jigjiga Export Slaughter House (JESH) PLC, Somali Regional
State, Federal Democratic Republic of Ethiopia
Javier Guillén AAALAC International, Pamplona, Spain
Alon Harmelin Department of Veterinary Resources, The Weizmann Institute of
Science, Rehovot, Israel
Amanda R. Hau Faculty of Law, University of Lund, Lund, Sweden
Jann Hau Faculty of Health and Medical Sciences, University of Copenhagen; and
Department of Experimental Medicine, University Hospital, Copenhagen, Denmark
xvii
xviii Contributors
Chou-Chu Hong AAALAC International, New Taipei City, Taiwan
Rony Kalman Hebrew University, Jerusalem, Israel
Joanna Debby Khoo Agri-Food and Veterinary Authority of Singapore, Singapore
Tsutomu Miki-Kurosawa The Institute of Experimental Animal Sciences,
Osaka University Medical School, Suita-shi, Osaka, Japan
Abdul Rahim Mutalib Department of Veterinary Pathology and Microbiology,
Faculty of Veterinary Medicine, University Putra Malaysia, Serdang, Malaysia
Christian E. Newcomer Association for Assessment and Accreditation of Laboratory
Animal Care International, Frederick, MD, USA
Denise Noonan The University of Adelaide, SA, Australia
Yasmina Arditi Paramastri Department of Pathology, Microbiology and
Immunology, Vanderbilt University Medical Center, Nashville, TN, USA
Jae Hak Park Laboratory Animal Medicine, College of Veterinary Medicine,
Seoul National University, Seoul, Korea
Peter Penson Rosanna, Victoria, Australia
Jan-Bas Prins Leiden University Medical Centre, Leiden, The Netherlands
Syed SYH. Qadri National Institute of Nutrition (ICMR), Hyderabad,
Andhra Pradesh, India
Dondin Sajuthi Primate Research Center, Veterinary Teaching Hospital,
Bogor Agricultural University (IPB), Bogor, Indonesia
John Schofield J & L Consulting, New Zealand
David Smith FELASA, Chester, UK
Ouajdi Souilem Laboratory of Physiology and Pharmacology, National School
of Veterinary Medicine, Sidi Thabet, Tunisia
Patri Vergara International Council for Laboratory Animal Science (ICLAS)
Jason Villano Unit for Laboratory Animal Medicine, University of Michigan
Medical School, Ann Arbor, MI, USA
Jianfei Wang GlaxoSmithKline R&D China, Pudong, Shanghai, P.R. China
Imelda Liunanita Winoto Primate Research Center, Bogor Agricultural University,
Bogor, Indonesia
Ehud Ziv Diabetes Research Unit, Hadassah University Hospital, Jerusalem, Israel
Chapter 1
Same Principles, Some
Differences
Javier Guillén1 and Patri Vergara2
1AAALAC International, 2International Council for Laboratory Animal Science (ICLAS)
Animals play an essential role in the development of many areas of science. Science,
as in many other activities of human life, is being globalized, and the care and use
of animals in science is being subjected to this transformation. Globalization of
science implies an increase in the level of collaborative research, which may be
affected by different cultural and legal requirements. Societal ethical concerns on
animal use for scientific purposes have led to the development and implementa-
tion of regulatory frameworks in many geographical areas. And even in those areas
where specific regulations do not exist, practices in the field are greatly influenced
by them. Communication and the spread of science, as well as increasing interin-
stitutional collaboration and outsourcing, are also important factors.
When reviewing the existing regulations described in this book, one easily
realizes that although there are differences in the way they are implemented,
they share the same ethical core principles. The same principles also underlie
most nonstatutory guidelines, or recommendations, on the care and use of labo-
ratory animals.
However, there are still differences in the way these principles are defined—
both within the regulations and in their implementation. When principles are
enshrined in legislation, legislators inevitably feel the need to provide definition
and to establish clear boundaries between what is legal and what is not. This
is the reason for the variation in standards that we so frequently find across
countries or geopolitical areas. Why do they differ? We can identify a number
of reasons including tradition, politics, financial implications, pragmatism, cul-
ture, etc. The outcome is the large variation in requirements and standards for
such things as regulatory bodies, personal responsibilities, cage and enclosure
dimensions, etc. This creates the current situation where we all speak about the
same aims and follow the same principles, but where animals are treated dif-
ferently in practice; differences that can have an adverse effect on collaborative
research.
However, there is also a very positive side to this development. The increased
use of laboratory animal welfare legislation has created new regulations in areas
Laboratory Animals. http://dx.doi.org/10.1016/B978-0-12-397856-1.00001-5
Copyright © 2014 Elsevier Inc. All rights reserved. 1
2 Laboratory Animals
where they did not exist before and has prompted the revision and improvement
of existing laws and guidelines. While it is true that the same outcomes can be
achieved by different means, the use of performance standards is spreading, thus
providing a very powerful tool for harmonization. And this is mainly thanks
to the interest, energy, and enthusiasm of the laboratory animal professionals
who are continuously seeking to spread knowledge, ethical principles, and good
practices across the world. International organizations are the key to achieving
these, and there are very good examples. The International Council for Labora-
tory Animal Science (ICLAS), with its national, scientific, institutional, associ-
ate, and affiliate members, is playing an important role. For example, ICLAS has
collaborated with Council for International Organizations for Medical Sciences
to revise the International Guiding Principles for Biomedical Research Involv-
ing Animals.1 These principles, which are in accordance with the principles of
the regulations described in this book, can facilitate the advancement of inter-
national collaboration in biomedical sciences. The Association for the Assess-
ment and Accreditation of Laboratory Animal Care (AAALAC International)
has accredited around 900 animal care and use programs in almost 40 countries
around the globe, serving as a unique tool for the improvement and harmoniza-
tion of animal care and use standards and practices. Several AAALAC members
have contributed to this book due to their international expertise. The World
Organization for Animal Health has focused on animal welfare and the use of
animals in research and education in different chapters of the Terrestrial Code.2
The principles described in Chapter 6.1 are perfectly aligned with the princi-
ples in all laboratory animal regulations and are developed for animals used in
research and education in Chapter 6.8.
At a more regional level, national associations have established umbrella
organizations that contribute to the same aim. The recommendations of the
Federation of European Laboratory Animal Science Associations (FELASA)
are well known and recognized,3 and similar organizations such as the Asian
Federation of Laboratory Animal Science Associations and the Federation
of South American Laboratory Animal Science Associations exist in Asia
and South America. It is noteworthy to mention the initiative of FELASA and
the American Association for Laboratory Animal Science (AALAS) to create
the AALAS-FELASA Liaison Body, which is working on the development of
common sets of recommendations.
This book includes the main regulations and guidelines used in 11 geograph-
ical areas of the world, from the most regulated environments (e.g. Europe) to
others where it is hardly possible to identify specific regulations (e.g. Africa).
Some information will not be included in this book; in some instances, it was
not possible to detail as in the case of multinational areas; in other cases, it was
not possible to get specific information, as for example, from Arabian countries.
Although no such regulations are included in this book, there are an increasing
number of institutions in several Arabian countries establishing quality animal
care and use programs in modern facilities.
Chapter | 1 Same Principles, Some Differences 3
If science is to advance faster and for the benefit of humans, animals, and the
environment, then ideally, laboratory animal regulations should have no politi-
cal frontiers. Over time, reference books may become outdated. We hope this
book becomes outdated soon, provided the reason is that there is no need to
describe multiple regulations—only one.
REFERENCES
1. Council for International Organizations for Medical Sciences; and International Council for
Laboratory Animal Science 2012. International Guiding Principles for Biomedical Research
Involving Animals. Available at: www.iclas.org.
2. World Health Organization. Terrestrial Animal Health Code 2012. Available at: http://www.
oie.int/international-standard-setting/terrestrial-code/access-online/.
3. Guillen J. FELASA guidelines and recommendations. J Am Assoc Lab Anim Sci 2012;51(3):311–21.
Chapter 2
Oversight of Research Animal
Welfare in the United States
John F. Bradfield1, B. Taylor Bennett2, and Cynthia S. Gillett3
1AAALAC International, Frederick, MD, USA, 2National Association for Biomedical Research,
Washington, DC, USA, 3University of Minnesota, Minneapolis, MN, USA
Chapter Outline
Introduction 6 The Cornerstones of
The Animal Welfare Act (Public Research Animal
Law 89-544)1 8 Oversight in the US 15
Public Health Service Policy The Principles 16
(PHS Policy)2 10 AWA/AWR’s 16
The Guide for the Care and Use PHS Policy and OLAW 16
of Laboratory Animals Scope/Applicability 18
(NRC 2011)5 11 AWA/AWR’s 18
Guide for the Care and Use PHS Policy and OLAW 18
of Agricultural Animals in Authorization of User-Breeding
Research and Teaching (FASS, Institutions/Inspections/Penalties
2010)6 12 by Competent Authorities 19
US Government Principles for AWA/AWR’s 19
the Utilization and Care PHS Policy and OLAW 21
of Vertebrate Animals Used in AAALAC International 22
Testing, Research, and Training Nonhuman Primates: Special
(Federal Register, Vol. 50, No. Considerations
97, 1985)21 (US Government and Restrictions 22
Principles) 13 AWA/AWR’s 22
The American Veterinary PHS Policy and OLAW 23
Medical Association Guidelines Genetically Altered Animals:
on Euthanasia 14 Special Consideration 24
The Association for the AWA/AWR’s 24
Assessment and Accreditation PHS Policy and OLAW 24
of Laboratory Animal Care, Institutional and Designated
International 15 Personnel Responsibilities 25
Laboratory Animals. http://dx.doi.org/10.1016/B978-0-12-397856-1.00002-7
Copyright © 2014 Elsevier Inc. All rights reserved. 5
6 Laboratory Animals
AWA/AWR’s 25 PHS Policy and OLAW 37
PHS Policy and OLAW 26 Housing and Enrichment 39
Oversight and Ethical Review AWA/AWR’s 39
Process 28 PHS Policy and OLAW 40
AWA/AWR’s 28 Husbandry and
PHS Policy and OLAW 28 Environment 43
Reuse 31 AWA/AWRs 43
AWA/AWR’s 31 PHS Policy and OLAW 43
PHS Policy and OLAW 31 Veterinary Care 46
Setting Free/Rehoming 32 AWA/AWRs 46
AWA/AWR’s 32 PHS Policy and OLAW 47
PHS Policy and OLAW 32 Conduct of Experimental
Occupational Health and Safety Procedures 49
32 AWA/AWRs 49
AWA/AWR’s 32 PHS Policy, OLAW 49
PHS Policy and OLAW 33 Euthanasia 51
Occupational Health and Safety AWA/AWRs 51
in the Care and Use AVMA Guidelines on
of Research Animals 35 Euthanasia 51
Education, Training, and PHS Policy and OLAW 53
Competence of Personnel 35 Equipment and Facilities 54
AWA/AWR’s 35 AWA/AWRs 54
PHS Policy and OLAW 36 PHS Policy and OLAW 54
Transport 37 Miscellaneous 57
AWA/AWR’s 37 AWA/AWRs 57
INTRODUCTION
The United States (US) has many regulations and guidelines regarding the care
and use of animals. A comprehensive review of all laws, regulations, and guide-
lines in the US regarding the welfare, care, and use of animals is beyond the
scope of this chapter, but the key regulations and guidelines that impact the
care and use of animals in research and teaching will be covered. In many ways
the oversight framework for animal use is a reflection of societal values and
priorities regarding the overall standing of animals in society. The regulatory
landscape in the US, as in many other countries, is continuously evolving and as
one reviews the current standards, it must be kept in mind that the implementa-
tion of animal use oversight is a rather dynamic process which depends on our
evolving understanding of animals, their needs and our obligation to be good
stewards when they are in our care.
The careful consideration of animal welfare guidelines and policies involves
an international perspective. The US has animal welfare laws, guidelines, and
Chapter | 2 Oversight of Research Animal Welfare in the United States 7
policies that are by their very nature, US-based. However, there is a global view
of animal welfare that impacts the US landscape in tangible ways. While non-
US-based laws and guidelines do not carry a statutory requirement in the US,
they are often used as appropriate resources that impact animal care and use in
this country.
The key regulations and guidelines that will be the focus of this chapter
include the Animal Welfare Regulations as mandated in US law, the Animal
Welfare Act (PL-89-544),1 the Public Health Service Policy on Humane Care
and Use of Laboratory Animals2 (PHS Policy), which is a statutory mandate
of the Health Research Extension Act of 1985, “Animals in Research” (PL-
99-158),3 and the US Government Principles for the Utilization and Care of
Vertebrate Animals Used in Testing, Research, and Training.4 Apart from the
Animal Welfare Regulations, the Guide for the Care and Use of Laboratory
Animals (Guide, NRC, 2011),5 further details the requirements of the PHS
Policy and is used by institutions to comply with the PHS Policy. For agricul-
tural animals used in research and teaching, a similar set of guidelines has been
published by the Federation of Animal Science Societies, the “Guide for the
Care and Use of Agricultural Animals in Research and Teaching” (Ag Guide,
FASS, 2010).6 Another set of guidelines with universal use are the Guidelines
on Euthanasia (2013) published by the American Veterinary Medical Associa-
tion (AVMA).7
The focus of these regulations and guidelines are not meant to imply that the
many others that impact animal use and welfare are not important, but simply to
direct attention to the core of animal welfare standards in the US which focus on
animals in research, teaching, and testing. The US has many relevant guidelines
and regulations about animals and welfare, several of which are listed below.
The breadth and scope of these laws and guidelines are simply too great to
include in one chapter, but these help provide the overall framework in the US
regarding the consideration of animal welfare.
A partial list of additional regulations and guidelines in the US include:
the Humane Methods of Slaughter Act,8 Horse Protection Act,9 Twenty-Eight
Hour Law,10 Guidelines for the Humane Transportation of Research Animals,11
Guidelines of the American Society of Mammalogists for the Use of Wild
Mammals in Research,12 Guidelines to the Use of Wild Birds in Research,13
Psychological Well-Being of Nonhuman Primates,14 Guidelines for the Welfare
and Use of Animals in Cancer Research,15 Guidelines for the Care and Use of
Mammals in Neuroscience and Behavioral Research,16 Guidelines for Use of
Live Amphibians and Reptiles in Field and Laboratory Research,17 and Envi-
ronmental Enrichment for Nonhuman Primates Resource Guide.18
These and many other guidelines are used throughout the US as they apply
to a particular species, or discipline of research and are often developed by
the various research societies engaged in animal-related research that consider
the humane care and use of animals paramount in the conduct of high quality
science.