DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS

PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000

Committee on Regulatory Issues in Animal Care and Use

Institute for Laboratory Animal Research

National Research Council

NATIONAL ACADEMY PRESS
Washington, D.C.



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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 Committee on Regulatory Issues in Animal Care and Use Institute for Laboratory Animal Research National Research Council NATIONAL ACADEMY PRESS Washington, D.C.

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 NATIONAL ACADEMY PRESS 2101 Constitution Avenue, NW Washington, DC 20418 NOTICE: The project that is the subject of these proceedings 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 project were chosen for their special competences and with regard for appropriate balance. This study was supported by Grant No. N01-0D-4-2139 between the National Academies and the National Institutes of Health of the U.S. Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number 0-309-07291-3 Definition of Pain and Distress and Reporting Requirements for Laboratory Animals: is available from the National Academy Press , 2101 Constitution Ave., NW, Washington, DC 20418; 800-624-6242 or 202-334-3313 in the Washington metropolitan area; Internet: www.nap.edu. Copyright 2000 by the National Academy of Sciences. All rights reserved. Printed in the United States of America.

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 THE NATIONAL ACADEMIES National Academy of Sciences National Academy of Engineering Institute of Medicine National Research Council 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. Bruce M. Alberts 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. William 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. Kenneth I. Shine 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. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 COMMITTEE ON REGULATORY ISSUES IN ANIMAL CARE AND USE Adele Douglass, American Humane Association, Washington, D.C. Randall J. Nelson, Department of Anatomy and Neurobiology, University of Tennessee, Memphis, Tenn. William S. Stokes, Environmental Toxicology Program, National Institute of Environmental Health Science, Research Triangle Park, N.C. Jerrold Tannenbaum, Department of Population and Health Reproduction, University of California School of Veterinary Medicine, Davis, Calif. Joanne Zurlo, Center for Alternatives to Animal Testing, Johns Hopkins School of Hygiene and Public Health, Baltimore, Md. Staff Ralph B. Dell, Director Kathleen A. Beil, Administrative Assistant Susan S. Vaupel, Editor Marsha K. Williams, Project Assistant

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 INSTITUTE FOR LABORATORY ANIMAL RESEARCH COUNCIL Peter A. Ward (Chair), Department of Pathology, University of Michigan Medical School, Ann Arbor, Mich. Bennett Dyke, Southwest Foundation for Biomedical Research, San Antonio, Tex. Rosemary W. Elliott, Department of Molecular and Cellular Biology, Roswell Park Cancer Institute, Buffalo, N.Y. G. F. Gebhart, Department of Pharmacology, College of Medicine, University of Iowa, Iowa City, Iowa Gail E. Herman, Children's Hospital Research Foundation, Columbus, Ohio Hilton J. Klein, Department of Laboratory Animal Resources, Merck Research Laboratories, West Point, Pa. Margaret S. Landi, Department of Laboratory Animal Science, SmithKline Beecham Pharmaceuticals, King of Prussia, Pa. William Morton, Regional Primate Research Center, University of Washington, Seattle, Wash. Randall J. Nelson, Department of Anatomy and Neurobiology, University of Tennessee, Memphis, Tenn. Robert J. Russell, Harlan Sprague Dawley, Inc., Indianapolis, Ind. William S. Stokes, Environmental Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, N.C. Michael K. Stoskopf, Departments of Clinical Sciences and Technology, College of Veterinary Medicine, North Carolina State University, Raleigh, N.C. John G. Vandenbergh, Department of Zoology, North Carolina State University, Raleigh, N.C. Thomas Wolfle, Annapolis, Md. Joanne Zurlo, Center for Alternatives to Animal Testing, Johns Hopkins School of Hygiene and Public Health, Baltimore, Md. Staff Ralph B. Dell, Director Kathleen A. Beil, Administrative Assistant Susan S. Vaupel, Editor Marsha K. Williams, Project Assistant

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 COMMISSION ON LIFE SCIENCES Michael T. Clegg (Chair), Department of Botany and Plant Science, University of California, Riverside, Calif. Paul Berg (Vice Chair), Stanford University School of Medicine, Stanford, Calif. Frederick R. Anderson, Cadwalader, Wickersham & Taft, Washington, D.C. Joanna Burger, Division of Life Sciences, and Environmental and Occupational Health Sciences Institute, Rutgers University, Piscataway, N.J. James E. Cleaver, University of California Cancer Center, San Francisco, Calif. David Eisenberg, UCLA-DOE Laboratory of Structural Biology and Molecular Medicine, University of California, Los Angeles, Calif. Neal L. First, Department of Animal Science, University of Wisconsin, Madison, Wisc. David J. Galas, Keck Graduate Institute of Applied Life Science, Claremont, Calif. David V. Goeddel, Tularik, Inc., South San Francisco, Calif. Arturo Gomez-Pompa, Department of Botany and Plant Sciences, University of California, Riverside, Calif. Corey S. Goodman, Department of Molecular and Cell Biology, University of California, Berkeley, Calif. Jon W. Gordon, Department of Obstetrics and Gynecology, Mount Sinai School of Medicine, New York, N. Y. David G. Hoel, Department of Biometry and Epidemiology, Medical University of South Carolina, Charleston, S.C. Barbara S. Hulka, Department of Epidemiology, University of North Carolina, Chapel Hill, N.C. Cynthia J. Kenyon, Department of Biochemistry, University of California, San Francisco, Calif. Bruce R. Levin, Department of Biology, Emory University, Atlanta, Ga. David M. Livingston, Dana-Farber Cancer Institute, Boston, Mass. Donald R. Mattison, March of Dimes, White Plains, N.Y. Elliot M. Meyerowitz, Division of Biology, California Institute of Technology, Pasadena, Calif. Robert T. Paine, Department of Zoology, University of Washington, Seattle, Wash. Ronald R. Sederoff, Department of Forestry, North Carolina State University, Raleigh, N.C. Robert R. Sokal, Department of Ecology and Evolution, State University of New York at Stony Brook, N.Y. Charles F. Stevens, MD, Salk Institute for Biological Studies, La Jolla, Calif.

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 Shirley M. Tilghman, Department of Molecular Biology, Princeton University, Princeton, N.J. Raymond L. White, Department of Oncological Sciences, University of Utah School of Medicine, Salt Lake City, Utah Staff Warren Muir

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 Preface In this first in a proposed series of workshops on regulatory issues in animal care and use, the Institute for Laboratory Animal Research (ILAR) has addressed the existing and proposed requirements for reporting pain and distress in laboratory animals. The Animal Welfare Act, administered by the Animal and Plant Health Inspection Service of the United States Department of Agriculture (USDA), mandates that pain and distress in laboratory animals be minimized. USDA is considering two policy changes with regard to this specific mandate. Firstly, since there has been no functional definition of “distress,” USDA has prepared such a definition and requested feedback from the scientific community on its usefulness for regulatory and reporting requirements. (See Appendix B.) The second issue concerns the pain and distress categorization scheme for reporting to USDA. Various groups and individuals have questioned the efficacy of the current categories, and specific changes have been proposed by the Humane Society of the United States. USDA is considering these and other potential changes to the existing scheme. Thus, given these potential changes to animal welfare policy, the aim of the ILAR/NIH joint workshop was to provide feedback to the USDA. The speakers were asked to address these two issues as well as to comment upon whether the information contained in the 1992 ILAR report Recognition and Alleviation of Pain and Distress in Laboratory Animals is still useful to investigators in assisting them to comply with regulations. The speakers provided perspectives based on their individual expertise in the areas of science of pain and distress, animal welfare policy, protocol review, and/or as representatives of relevant organizations or institutions. The following proceedings are an edited transcript of their presentations.

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 Contents     Introduction Ralph B. Dell   1     Pain and Distress: USDA Perspective W. Ron DeHaven   3     Pain, Distress, and Reporting Requirements: PHS Policy Perspective Nelson Garnett   9     Assessing Pain and Distress: A Veterinary Behaviorist's Perspective Kathryn Bayne   13     Scientific Issues of Pain and Distress G. F. Gebhart   22     The Humane Society of the United States Pain and Distress Initiative Andrew N. Rowan   31     Pain and Distress Caused by Experimental Procedures—Is It Time for a Reality Check? Alicia Karas   37     A View from the Trenches B. Taylor Bennett   44

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000     AALAS Position Paper on the “Recognition and Alleviation of Pain and Distress in Laboratory Animals ” Marcelo Couto   53     On Regulating Pain and Distress J. R. Haywood and Molly Greene   58     An Industrial Perspective Lynn C. Anderson   63     Corners Still Unswept John E. Harkness   71     Personal Experiences with Clinical Pain Management, Study Design, Mitigation of Scientific Confounders, and Long-term Gains to the Researchers and Public Victoria Hampshire   77     Use of Laboratory Animals in the Postgenome Era Robert R. Rich   82     The History and Histrionics of Pain and Distress in Laboratory Animals Christian E. Newcomer   87     Panel Discussion with All Speakers   93  Appendix A   APHIS/USDA Policy 11 and Policy 12   99  Appendix B   Proposed Rulemaking   104  Appendix C   Glossary of Abbreviations   112  Appendix D   Meeting Participants   113  Appendix E   Meeting Agenda   115  Appendix F   Biographical Sketches of Committee Members   118