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Guidelines for the Humane Transportation of Research Animals
GUIDELINES FOR THE HUMANE TRANSPORTATION OF RESEARCH ANIMALS
Committee on Guidelines for the Humane Transportation of Laboratory Animals
Institute for Laboratory Animal Research
Division on Earth and Life Studies
NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu
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Guidelines for the Humane Transportation of Research Animals
THE NATIONAL ACADEMIES PRESS,
500 Fifth Street, N.W., Washington, DC 20001
NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.
This study was supported by the Elizabeth R. Griffin Research Foundation, the National Center for Infectious Disease, and Contract No. N01-OD-4-2139, Task Order 118 between the National Institutes of Health and the National Academy of Sciences. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the organizations or agencies that provided support for the project. The content of this publication does not necessarily reflect the views or policies of the National Institutes of Health, nor does mention of trade names, commercial products, or organizations imply endorsement by the US government.
Library of Congress Cataloging-in-Publication Data
Guidelines for the humane transportation of research animals / Committee on Guidelines for the Humane Transportation of Laboratory Animals, Institute for Laboratory Animal Research, Division on Earth and Life Studies.
p. ; cm.
Includes bibliographical references and index.
ISBN 0-309-10110-7 (pbk.)
1. Laboratory animals—Transportation. I. Institute for Laboratory
Animal Research (U.S.). Committee on Guidelines for the Humane Transportation of Laboratory Animals.
[DNLM: 1. Animals, Laboratory—Guideline. 2. Transportation—standards—Guideline. 3. Animal Welfare—standards—Guideline. 4. Laboratory Animal Science—standards—Guideline. 5. Safety Management—standards—Guideline. QY 52 G946 2006]
SF406.7.G85 2006
636.088′5—dc22
2006010872
ISBN 0-309-65724-5 (PDF)
Additional copies of this report are available from the
National Academies Press,
500 Fifth Street, NW, Lockbox 285, Washington, DC 20001; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu
Disclaimer:
The Internet information and government forms referenced in this report were correct, to the best of our knowledge, at the time of publication. It is important to remember, however, the dynamic nature of the Internet. Resources that are free and publicly available one day may require a fee or restrict access the next, and the location of items may change as menus and homepages are reorganized.
Copyright 2006 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
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Guidelines for the Humane Transportation of Research Animals
THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.
The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering.
The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.
The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council.
www.national-academies.org
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This report is respectfully dedicated to the memory of
CHARLES KEAN
March 25, 1942 – June 25, 2004
who dedicated his life to the care of humans and animals alike
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COMMITTEE ON GUIDELINES FOR THE HUMANE TRANSPORTATION OF LABORATORY ANIMALS
Ransom L. Baldwin (Chair),
University of California, Davis, California
Chandra R. Bhat,
University of Texas, Austin, Texas
Donald H. Bouyer,
University of Texas, Galveston, Texas
Firdaus S. Dhabhar,
Stanford University School of Medicine, Stanford, California
Steven L. Leary,
Washington University School of Medicine, St. Louis, Missouri
John J. McGlone,
Texas Tech University, Lubbock, Texas
Eric Raemdonck,
International Air Transport Association, Montreal, Quebec, Canada
Jennie L. Smith,
Yale University, New Haven, Connecticut
Janice C. Swanson,
Kansas State University, Manhattan, Kansas
Staff
Jennifer Obernier, Study Director
Marsha Barrett, Project Assistant
Kathleen Beil, Administrative Assistant
Kori Brabham, Intern
Norman Grossblatt, Senior Editor
Johnny Hernandez, Intern
John Horigan, Fellow
Susan Vaupel, Editor
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INSTITUTE FOR LABORATORY ANIMAL RESEARCH COUNCIL
Stephen W. Barthold (Chair),
University of California, Center for Comparative Medicine, Davis, California
William C. Campbell,
Drew University, Madison, New Jersey
Jeffrey I. Everitt,
GlaxoSmithKline Research and Development, Comparative Medicine and Investigator Support, Research Triangle Park, North Carolina
Michael F. Festing,
Leicestershire, United Kingdom
James G. Fox,
Massachusetts Institute of Technology, Division of Comparative Medicine, Cambridge, Massachusetts
Estelle B. Gauda,
Johns Hopkins University School of Medicine, Johns Hopkins Hospital, Baltimore, Maryland
Janet Gonder Garber,
Pinehurst, North Carolina
Coenraad F.M. Hendriksen,
Netherlands Vaccine Institute, Bilthoven, The Netherlands
Jon H. Kaas,
Vanderbilt University, Nashville, Tennessee
Jay R. Kaplan,
Wake Forest University School of Medicine, Department of Pathology, Winston-Salem, North Carolina
Joseph W. Kemnitz,
University of Wisconsin, Primate Research Center, Madison, Wisconsin
Leticia V. Medina,
Abbott Laboratories, Abbott Park, Illinois
Abigail L. Smith,
University of Pennsylvania, University Laboratory Animal Resources, Philadelphia, Pennsylvania
Stephen A. Smith,
Virginia Polytechnic Institute and State University, Department of Biomedical Sciences and Pathobiology, Blacksburg, Virginia
Peter Theran,
Massachusetts Society for the Prevention of Cruelty to Animals, Angell Animal Medical Center, Boston, Massachusetts
Staff
Joanne Zurlo, Director
Kathleen Beil, Administrative Assistant
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Preface
This project was initiated in response to a letter from Charles Kean, an Associate Professor of Physiology and Pharmacology and Director of the Animal Care Facility at Loma Linda University, to the National Research Council’s (NRC’s) Institute for Laboratory Animal Research (ILAR), the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International, and the Office of Laboratory Animal Welfare (OLAW) of the National Institutes of Health (NIH) outlining the research animal care community’s concerns about the safe and humane transportation of research animals. Dr. Kean requested that those organizations look into the transportation of research animals and into issues that were adversely affecting animal welfare. In response, ILAR hosted a meeting of various stakeholders to identify and discuss important issues in the transportation of research animals. The meeting was funded by NIH and included representatives of the scientific community, professional veterinary organizations, regulatory and accrediting agencies, animal breeders, and the transportation industry. Special thanks are due to the following for participating in the meeting, which took place December 4, 2001:
Kathryn Bayne, AAALAC International
Frank Black, Air Transportation Association of America, Inc.
Ralph Dell, ILAR
Nelson Garnett, OLAW
James Geistfeld, Taconic Farms, Inc.
Charles Kean, Loma Linda University
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Carl Kole, United Airlines
J. Michael Krop, US Postal Service
Steven Leary, Washington University
Emilie Rissman, University of Virginia
Robert Russell, Harlan Sprague Dawley, Inc.
James Taylor, Office of Animal Care and Use, NIH
Richard Watkins, US Department of Agriculture (USDA) Animal and Plant Health Inspection Service
William White, Charles River Laboratories
The meeting delineated the problems encountered during and resulting from air and ground transportation of live animals. The participants also focused on mechanisms to solve the problems, including the potential for a future ILAR study. As a result of this meeting, the Elizabeth R. Griffin Research Foundation, NIH, and the National Center for Infectious Diseases sponsored an ILAR committee to address problems associated with transportation of research animals and produce a report that includes recommendations intended for government agencies as well as for individual investigators/animal facility managers who may need to ship animals in the future.
Transportation of research animals may raise concerns related to the well-being of the animals and concerns about how animals are affected by general environmental conditions. These concerns often depend on the species being transported. Shipments from breeders to research institutions are generally well executed through the use of company-owned fleets of environmentally controlled vehicles, but arranging transport from vendors without established transport systems, or between research institutions, can be challenging. Animals may be shipped in vehicles without controlled environments and could be subjected to extreme temperatures. Specific requests for temperature-controlled vehicles may not be honored because the shipper may not have temperature-controlled vehicles available or the request may not have been passed on to a subcontractor hired by the shipper to transport the animals. The USDA has regulatory jurisdiction and inspection authority over transportation of animals through the Animal Welfare Act. However, most animals shipped are rats and mice, which are not covered under the act. The Public Health Service, whose oversight does include those species, does not inspect research animal transportation activities unless a complaint is filed.
The major problem in transporting nonhuman primates is that few airlines are willing to carry the animals. International shipment, the most common transportation of nonhuman primates, is often delayed by a cumbersome, multiagency permitting process involving the USDA Vet-
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erinary Service, US Fish and Wildlife Service, the Centers for Disease Control and Prevention (CDC), and the Department of Transportation (DOT). Airlines have little incentive to carry the animals because it is not profitable and workers must wear protective clothing when handling them. The latter is disturbing both for workers and for travelers who see them. Finally, many animal rights activists have successfully lobbied the airlines to stop transporting nonhuman primates nationally and internationally.
Transportation of research animals is an essential component of the research enterprise. The integrity and well-being of the animals being transported are necessary for the quality of the research and the welfare of the animals. The lack of clear guidelines that cover all species can cause confusion for individuals without extensive experience in arranging transportation for research animals. In addition, investigators may find it difficult to identify a responsible shipper that will arrange for appropriate caging, inclusion of food and water, and other animal needs during transportation.
In the aftermath of the bioterror incidents involving anthrax in the fall of 2001, the possibility that research animals will be used to carry or disseminate bioterrorism agents must be considered. Breaches in good transportation practices, either purposeful or accidental, could result in the spread of infectious agents. In addition, new legislation (such as the Animal Health Protection Act of 2002) and several guidelines related to homeland security have the potential to complicate the importing, exporting, and transportation of animals and specimens for biomedical research.
The issues identified in the preceding statements led to appointment of the ILAR Committee on Guidelines for the Humane Transportation of Laboratory Animals. The committee held three meetings—in April, September, and December 2004. During the course of its deliberations, the committee sought assistance from many people, who gave generously of their time to provide valuable advice and information that were used in its deliberations. Special thanks are due to the following:
Richard Phelan, Taconic Farms, Inc.
Bonnie P. Dalton, Science Directorate, Ames Research Center, National Aeronautics and Space Administration
Gale Galland, Division of Global Migration and Quarantine, National Center for Infectious Diseases
Frank Kohn, FWS
John Monetti, World Courier
Erik Liebegott, Transportech, LLC
Robert Fernandez, Direct Services
William White, Charles River Laboratories
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Carol Wigglesworth, OLAW
Bobby Brown, CDC
Carl Kole, Special Cargos, United Airlines
Charles Kean, Animal Research Facility, Loma Linda University
Barbara Kohn, Office of Animal Care, USDA
Eileen Edmonson, Office of Hazardous Materials Safety, DOT
The report has been reviewed in draft form by individuals chosen for their diverse perspective and technical expertise, in accordance with procedures approved by the NRC’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of the report:
Susan Eicher, Purdue University, West Lafayette, IN
Steven Griffey, University of California, Davis, CA
Kathleen Hancock, Virginia Polytechnic University, Alexandria, VA
Barbara Hansen, All Children’s Hospital, St. Petersburg, FL
Donald Lay, Purdue University, West Lafayette, IN
Tim Morris, GlaxoSmithKline, United Kingdom
William Morton, Paris NHP, Edmonds, WA
Barbara Orlans, Georgetown University, Washington, DC
Frankie Trull, National Association for Biomedical Research, Washington, DC
William White, Charles River Laboratories, Wilmington, MA
Walter Woolf, Air Animal, Tampa, FL
Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of the report was overseen by:
Johanna Dwyer, Tufts University, Boston, MA
Steven Pakes, University of Texas Southwestern Medical Center and VA North Texas Health Care System, Dallas, TX
Appointed by the NRC, they were responsible for making certain that an independent examination of the report was carried out in accordance
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with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of the report rests entirely with the authoring committee and the institution.
Ransom L. Baldwin, Chair
Committee on Guidelines for the Humane Transportation of Laboratory Animals
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Contents
TABLES AND FIGURES
xvii
ABBREVIATIONS AND ACRONYMS
xix
SUMMARY
1
Major Recommendations,
3
1
INTRODUCTION
7
2
REGULATIONS AND GUIDELINES FOR THE TRANSPORTATION OF RESEARCH ANIMALS
11
National Regulations and Guidelines,
11
Department of Agriculture,
14
US Fish and Wildlife Service,
14
Centers for Disease Control and Prevention,
18
US Department of Transportation,
20
Public Health Service,
21
Food and Drug Administration,
21
State Health and Agricultural Regulations,
22
International Regulations for Transporting Research Animals,
22
CITES,
23
International Civil Aviation Organization,
25
International Air Transport Association,
27
World Animal Health Organization,
28
The European Union,
29
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3
GOOD PRACTICES IN THE TRANSPORTATION OF RESEARCH ANIMALS
33
Stress During Transportation,
34
Allometric Scaling and Implication for Transportation Practices,
38
Thermal Environment,
39
Space Allocation,
52
Food and Water,
54
Social Interaction and Group Transportation,
59
Handling,
59
Monitoring Transportation,
60
Emergency Procedures,
61
Personnel Training,
61
4
BIOSECURITY
65
Protecting Public Health and Agricultural Resources,
66
Protecting the Biological Integrity of Research Animals and Colonies,
71
5
RECOMMENDATIONS
81
REFERENCES
89
APPENDIXES
A
SUMMARY OF THE ANIMAL WELFARE ACT REGULATIONS PERTAINING TO TRANSPORTATION
97
Dogs and Cats (9 CFR 3.13 – 3.19),
97
Nonhuman Primates (9 CFR 3.86-3.92),
104
Guinea Pigs and Hamsters, Rabbits, and Other Animals (9 CFR 3.35-3.41, 9 CFR 3.60-3.65, 9 CFR 3.136 – 3.142),
110
B
PATTERNS IN THE GROUND TRANSPORTATION OF RESEARCH ANIMALS IN THE UNITED STATES
117
Background,
117
Data Preparation,
118
Quantitative Analysis,
119
Empirical Results,
120
Summary,
126
ABOUT THE AUTHORS
127
INDEX
131
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Tables and Figures
TABLE 1-1
Checklist of Issues to Consider When Arranging Transportation Between Research Facilities
10
TABLE 2-1
Federal Statutes/Programs Relevant to the Transportation of Vertebrate Research Animals and Products in the United States
12
TABLE 2-2
Designated Port for Importation or Exportation of Wildlife or Derivatives
16
TABLE 2-3
Endangered Species Act Listed Species of Nonhuman Primates
17
TABLE 2-4
Permitting Requirements Under CITES
25
TABLE 2-5
CITES Listed Species of Nonhuman Primates
26
TABLE 2-6
Checklist of Research Animal Regulations and Guidelines
31
TABLE 3-1
Thermoregulation Data on Common Research Animal Species
40
FIGURE 3-1
Graph representing relationship between metabolic rate and ambient temperature in homeotherms.
42
FIGURE 3-2
Changes in thermoneutral zone (range of ambient temperatures at which an animal’s heat production is at a minimum) with age and size in chickens.
43
FIGURE 3-3
TNZ of various agricultural animals.
44
TABLE 3-2
Ambient Temperature Ranges for Safe Transportation of Common Adult Research Animals
48
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TABLE 3-3
Effects of Various Factors on Effective Environmental Temperature and Relative Risk to Animal Health and Welfare
49
TABLE 3-4
Behavioral and Physiological Signs of Thermal Status
52
TABLE 3-5
Space Allowances for Group-Transported Animals
55
FIGURE 3-4
Space allowances during transportation.
57
TABLE 4-1
Agents and Toxins That Require Registration of the Facility with CDC
67
TABLE 4-2
Elements of an Emergency Plan
68
TABLE 4-3
Characteristics of a Good Shipper
68
TABLE 4-4
Examples of Zoonotic Diseases Transmissible from Research Animals to Humans
69
TABLE 4-5
Infectious Agents and the Susceptible Species of Research Animals
72
TABLE 4-6
Recommendations for Shipment of Research Animals Between Institutions
76
FIGURE 5-1
Locations of research facilities using nonhuman primates, major importation sites, and vendors of nonhuman primates in the United States.
83
FIGURE B-1
Candidate set for the facility-location problem.
121
FIGURE B-2
Solution set for the facility location problem for the NIH grants data set (rodents).
122
TABLE B-1
Total Weighted-System Travel-Distance Reduction with Increase in Supply Points for NIH Grants Data Set (Rodents)
123
TABLE B-2
Total Weighted-System Travel-Distance Reduction with Increase in Supply Points for USDA Cats Data Set
123
FIGURE B-3
Solution set for the facility location problem for the USDA cats data set.
124
FIGURE B-4
Solution set for the facility location problem for the USDA dogs data set.
125
TABLE B-3
Total Weighted-System Travel-Distance Reduction with Increase in Supply Points for USDA Dogs Data Set
126
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Abbreviations and Acronyms
AAALAC Association for Assessment and Accreditation of Laboratory Animal Care International
AATA Animal Transportation Association
APHIS Animal and Plant Health Inspection Service
AVMA American Veterinary Medical Association
AWA Animal Welfare Act
BMBL Biosafety in Microbiological and Biomedical Laboratories
CDC Centers for Disease Control and Prevention
CITES Convention on International Trade in Endangered Species of Wild Fauna and Flora
DGMQ Division on Global Migration and Quarantine
DRGs Dangerous Goods Regulations
DOT Department of Transportation
EAIPP Etiologic Agent Import Permit Program
EDIM Group A rotavirus
ESA Endangered Species Act
EU European Union
FASS Federation of Animal Science Societies
FDA Food and Drug Administration
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FY fiscal year
FWS Fish and Wildlife Service
GD-VII Theiler’s murine encephalomyelitis virus strain
GIS Geographic Information System
HANT Hantaan
HEPA high-efficiency particulate air (filters)
HMR Hazardous Materials Regulation
HPA hypothalamic pituitary adrenal axis
IATA International Air Transport Association
ICAO International Civil Aviation Organization
ILAR Institute for Laboratory Animal Research
KRV Kilham Rat virus
LARS Live Animals Regulations
LCM Lymphocytic choriomeningitis
LCMV Lymphocytic choriomeningitis virus
LCT lower critical temperature
MAD Mouse adenovirus
MCMV Murine cytomegalovirus
MHV Mouse hepatitis virus
MPV (OPV) Mouse parvovirus (Orphan parvovirus)
MTLV Mouse thymic virus
MVM Minute virus of mice
NAP National Academies Press
NCRR National Center for Research Resources
NIH National Institutes of Health
NPRC National Primate Research Center
NRC National Research Council
OIE Office International des Épizooties
OLAW Office of Laboratory Animal Welfare
PhRMA Pharmaceutical Research and Manufacturers of America
PHS Public Health Service
PPE personal protective equipment
PVM pneumonia virus of mice
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REO 3 Reovirus type 3
RHD Rabbit haemorrhagic disease
RPV (OPV) Rat parvovirus (Orphan parvovirus)
RRV Ross River virus
SARS Sudden Acute Respiratory Syndrome
SDA/RCV Sialodacryoadentitis virus/Rat corona virus
SIV Simian immunodeficiency virus
SPS Agreement Agreement on the Application of Sanitary and Phytosanitary Measures
TNZ thermoneutral zone
UCT upper critical temperature
USDA US Department of Agriculture
WTO World Trade Organization
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