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.
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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Committee on Regulatory Issues in Animal Care and Use, Institute for Laboratory Animal Research, National Research Council

Workshop on Definition of Pain and Distress and Reporting Requirements for Laboratory Animals

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Proceedings of the National Academy of Sciences USA

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National Academies Press

Compass series (Washington, D.C.), Washington, D.C, ©2000

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS 2
Copyright 3
Preface 10
Contents 12
Introduction 14
REFERENCE 15
Pain and Distress: USDA Perspective 16
POLICY 12 17
POLICY 11 17
EXPLANATION OF CATEGORIES 19
Column C 19
Column D 19
Column E 19
DISCUSSION 19
Pain, Distress, and Reporting Requirements: PHS Policy Perspective 22
INTERRELATED ISSUES 22
Similarity of Initiatives 23
RATS, MICE, AND BIRDS 24
HSUS PAIN AND DISTRESS INITIATIVE 25
CONCLUSION 25
REFERENCE 25
Assessing Pain and Distress: A Veterinary Behaviorist's Perspective 26
ASSESSING PAIN AND DISTRESS 26
The Dilemma of Definitions 26
Issues with Assessing Pain 27
Issues with Assessing Distress 27
Indicators of Pain 28
Indicators of Distress 29
Degrees of Stress 30
Using Behavior to Assess Pain and Distress 30
A Program of Pain and Distress Management 31
REFERENCES 32
QUESTIONS AND ANSWERS 32
Scientific Issues of Pain and Distress 35
PAIN VERSUS NOCICEPTION 35
Pain 35
Nociception 36
Noxious Stimuli 36
CLASSIFICATIONS OF PAIN 37
Protective Pain 37
Nonprotective Pain 38
TISSUE INJURY 39
Sensitization 39
Hyperalgesia 39
STRESS AND DISTRESS 41
Definition of Terms 41
Reduction with Preemptive Analgesia 41
CONCLUSION 42
REFERENCES 42
QUESTIONS AND ANSWERS 42
The Humane Society of the United States Pain and Distress Initiative 44
CONTEXT OF THE INITIATIVE 45
DEFINITIONS OF TERMS 45
ASSESSING DISTRESS 47
CONCLUSIONS 48
REFERENCES 49
QUESTIONS AND ANSWERS 49
Pain and Distress Caused by Experimental Procedures— Is It Time for a Reality Check? 50
UP-FRONT REPORTING 50
Predictability 50
Planning for Optimal Animal Care 51
CATEGORY D 52
PLANNING EXPERIMENTAL METHODS 53
SCIENTIFIC JOURNAL REPORTING 55
SUMMARY 56
REFERENCES 56
A View from the Trenches 57
WHO I AM 57
HOW I GOT HERE 58
WHY I CANNOT SUPPORT CHANGES IN THE EXISTING POLICY 58
WASTING OUR FISCAL AND HUMAN RESOURCES 61
REFERENCE 63
QUESTIONS AND ANSWERS 63
AALAS Position Paper on the “Recognition and Alleviation of Pain and Distress in Laboratory Animals” 66
EVALUATING PAIN AND DISTRESS 66
REPORTING ANIMAL USE 67
ALLEVIATING PAIN AND DISTRESS 67
TRAINING OF PERSONNEL 67
ROLES OF THE VETERINARIAN, IACUC, AND INVESTIGATOR 68
REFINEMENT 69
CONCLUSION 69
QUESTIONS AND ANSWERS 69
On Regulating Pain and Distress 71
BENEFIT THE ANIMALS 71
KEEP IT SIMPLE 72
ETHICAL ISSUES 74
QUESTIONS AND ANSWERS 75
An Industrial Perspective 76
SOURCES OF PAIN 76
ASSESSMENT 77
SHARED RESPONSIBILITY 77
Institutions 77
Investigators 77
IACUC 78
Veterinarians 78
PAIN AND DISTRESS INITIATIVES 79
HSUS 79
USDA 79
REPORTING 79
Categorization 79
CONCLUSION 80
REFERENCES 81
QUESTIONS AND ANSWERS 81
Corners Still Unswept 84
INTRODUCTIONS 84
My Life as a Rat 84
My Ignorant Colleagues 86
Rats and Your Cousins, I Love You 87
Overwhelmed 88
CONCLUSIONS 88
REFERENCES 89
Personal Experiences with Clinical Pain Management, Study Design, Mitigation of Scientific Confounders, and Long-term Gains... 90
EXPERIMENTAL EFFECTS ON ANIMALS 90
Results of Cumulative Minor Events 91
Multidimensional Risk 91
PROVISION OF NECESSARY IMPROVEMENT 92
Scheme of Veterinary Care 92
Shifting Responsibility for Performance Standards 92
ESTABLISHMENT OF PREREVIEW 93
SCIENTIFIC JOURNALS AS FACILITATORS 93
CONCLUSION 94
REFERENCES 94
Use of Laboratory Animals in the Postgenome Era 95
PREDICTABLE TRENDS IN RESEARCH 95
Systems Biology 95
Molecular Genetic Technology 96
PREDICTABLE CONSEQUENCES OF GENETIC BREEDING 96
Definitions and Categories 97
Procedures 97
Replication of Human Diseases 97
Experimental Endpoints 98
CONCLUSION 98
QUESTIONS AND ANSWERS 98
The History and Histrionics of Pain and Distress in Laboratory Animals 100
HISTORICAL PERSPECTIVE 100
Congressional Remarks 100
“Three Rs” 101
Attention to Language 101
Acknowledged Contributions of IACUCs 102
ANTICIPATED CHANGES 102
Multidimensional Impact 102
Inclusion of Rodents 102
Pursuit of Excellence 103
RECOMMENDED ALTERNATIVE LANGUAGE 103
Categories C and D 103
Category E 104
CONCLUSION 105
REFERENCES 105
Panel Discussion with All Speakers 106
Appendix A APHIS/USDA Policy 11 and Policy 12 112
POLICY #11—PAINFUL/DISTRESSFUL PROCEDURES—APRIL 14, 1997 112
POLICY #12—CONSIDERATION OF ALTERNATIVES TO PAINFUL/DISTRESSFUL PROCEDURES—JUNE 21, 2000 114
Appendix 2 Proposed Rulemaking 117
Appendix C Glossary of Abbreviations 125
Appendix D Meeting Participants 126
Appendix E Meeting Agenda 128
WORKSHOP ON DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS 128
AGENDA 128
Appendix F Biographical Sketches of Committee Members 131

2018-01-31