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USE OF BURY ANIMAL IN BIOMEDICAL AND BEHAVIORAL ARCH Committee on the Use of Laboratory Animab in Biomedical add Behavioral Research Commission on Life Sciences National Research Council Institute of Medicine NATIONAL ACADEMY PRESS Washington, D.C. 1988

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NOTICE: The project that is the subject of this report was approved bar 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, "d 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 report has been reviewed by a group other tom the authors according to procedurce approved by a Report Review Committee connoting of members of the National Academy of Sciences, the National Academy of Engineering, Ad the Institute of Medicine. The National Academy of Sciences is a private, nonprofit, sell-perpetuating society of distinguished scholars engaged in scientific and engineering resee - , dedicated to the furtherance of science Ad technology Ad to their "e for the general welfare. Upon the authority of the charter granted to it by the Congress ~ 1863, the Academy has a mandate that requires it to advise the federa`1 government on scientific and technical matters. Dr Fran Prces ~ president of the National Academy of Sciences. The National Academy of Engineering was cetabli~hed in 1964, under tEc charter of the National Academy of Sciences, as a parallel organization of ontst~n cling engineers. It is autonomous in its administration and in the selection of its members, shanug with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering program aimed at meeting national needs, encourages education "d research, and recognizes the superior achievements of engmeere. Dr. Robert M. White ~ president of the National Academy of E:ngineer~g. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of emment members of appropriate professions ~ 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 "d upon its own initiative, to identify issues of medical care, regears, and education. Dr. Samuel O. Thier is president of the Institute of Medicine. The National Research Council was established 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 "d of addling the federal government. Functioning in accord~cc 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 ~ administered jointly by both Academies and the Institute of Medicine. Dr. Prank Pro" and Dr. Robert M. White are chairman and vices airman, respectively, of the National Research Council. This project was undertaken with both public and priorate sector support. The following agencies of the federal government provided major funding for the study: the Departments of the Air Force, Army, and Nary; the National Institutes of Health; and the National Science Foundation. The following private org~isation~ also provided support: Abbott Laboratories, American Cyanamid Co., America Hoechet Corp., Berlex Laboratories Inc., Bristol-Myers Co., Burroughs Wellcome Co., Ciba-Geigy Corp., E. I. DuPont de Nemours ~ Co., Marion Laboratories Inc., Pfiscr Inc., A. H. Robins Co., Rorer Group Inc., Sandos Pharmaceuticals Corp., Schering-Plough Corp.1 Searle Research and Development, Shell Development Co., Sterling Dmg Inc., Syntex Corp., and the Upiobn Co. This worn is related to Department of the Navy Grant No. N00014-85-G-0247 issued by the Officc of Natural Research. The United States Go~rerr~ment has a royalty-free liceD.se throughout the world in all copyrightable material contained herein. Library of Congress Catalog Card Number 88-62248 ISBN 0 309 03839 1 _ Printed in the IJnited States of America First Printing, September 1988 Second Panting, January 1989 Third Printing, April 1989 Fourth P'iniiIIg, September 1989 Fifth Pnoting, July 1990 Sloth Printing, November 199() Seventh Priming, December 1991

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COMMITTEE ON THE USE OF [ABO}~ATORY AN~A[S I'{ BIOMEDICAL AND BEHAVIORAL RESEARCH NORMAN HACKERMAN ~ Chairman), Rice University KURT BENIRSCHKE, University of California, Son Diego Medical Center MICHAEL E. DEBAKEY, Baylor College of Medicine W. JEAN DODDS, New York State Department of Health, Albany, New York EDWARD L. GINZTON, Varian Associates, Inc., Palo Alto, California CARL W. GOTTSCHALK, The University of North Carolina, Chapel Hid ARTHUR C. GUYTON, University of Mississippi School of Medicine WILLIAM HUBBARD, The Upjohn Company, Hickory Corners, Michigan ~ OHN KAPLAN, Stanford University School of Law HAROLD J. MOROWITZ, Yale University CARL PFAPPMANN, The Rockefeller University DOMINICK P. PURPURA, Albert Einstein College of Medicine CHRISTINE STEVENS,* Animal Welfare Institute, Washington, D.C. LEWIS THOMAS, Memorial SIoan-Ketter~g Cancer Center, New York City JAMES MCKENDREE WALL, The Christian Century, Chicago, Nixon Staff JOHN E. BURRIS, Study Director JUNE S . EWING, Staff Officer STEVE OLSON, Editor MARGARET FULTON, Senior Secretary F RANCES WALTON, A dmin~trativc Secretary *Did not sign the report. .... 111

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COMMISSION ON LIFE SCIENCES JOHN E. DOWLING (Chairman), Harvard University PERRY L. ADKISSON, The Texas A&M University System, College Station FRANCISCO 3. AYALA, University of California, Irvine ]. MICHAEL BISHOP, University of California Medical Center, San Francisco NINA V . F EDOROFF, Carnegie Institution of Washington, Baltimore, Maryland TIMOTHY H. GOLDSMITH, Yale University RICHARD W. HANSON, Case Western Reserve University School of Medicine RALPH W. F . HARDY, Boyce Thompson Institute for Plant Research, Ithaca, New York DONALD F. HORNIG, Harvard School of Public Health ERNEST G. JAWORSKI, Monsanto Company, St. Louis, Missouri SIMON A. KEVIN, Cornell University F RANKLIN M. LOEW, Tufts University ROBERT W. MANN, Massachusetts Institute of Technology HAROLI) A. MOONEY, Stanford University JOSEPH E. RALL, National Institutes of Health, Bethesda, Maryland RICHARD D. REMINGTON, University of Iowa RICHARD B. SETLOW, Brookhaven National Laboratory, Upton, New York J OSEPH E . VARNER, Washington University NRC Governing Board Liaison Member RALPH LANDAU, ~istowei, incorporate], New York City Staff ALVIN G . LAZEN, Executive Director 1V

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Contents PREFACE EXECUTIVE SUMMARY e V11 1 INTRODUCTION 12 Historical Background, 12 Present Situation, 15 2 PATTERNS OF ANIMAL USE............................... Numbers of Animals Used, 19 Use of Animals in Research by the Federal Government, 22 Use of Animate in Education, 23 Use of Animals in Testing, 23 New Technologies and Future Laboratory Use of Animab, 25 Summary, 26 3 BENEFITS DERIVED FROM THE USE OF ANIMALS .... 27 Polio, 28 Acquired Immune Deficiency Syndrome, 28 Transplantation, 29 Cardiovascular-Renal Systems, 31 Nervous System, 32 Other Benefits for Humans, 36 Benefits for Animals, 36 Summary, 37 18 v

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V1 CON=NTS 4 ALTERNATIVE METHODS IN BIOMEDICAL AND BEHAVIORAL RESEARCH 38 Relationships Among Life Forms, 39 Animal Models, 40 Alternatives to Mammab, 41 Alternative Methods in Testing, 44 Summary, 46 5 REGULATORY ISSUES Approaches to Regulation, 47 Federal Regulations, 49 Government Policy Statements, 53 State Regulations, 56 Approaches to Regulation, 57 Effects of Regulations, 59 Enforcement and Enactment of Regulations and Laws, 62 6 USE OF POUND ANIMAI`S Supply of Pound Animals, 64 Regulations, 65 Scientific Considerations, 65 Benefits, 65 Cost Considerations, 66 Concerns for the Animals, 66 7 CONCLUSIONS AND RECOMMENDATIONS Recommendations, 69 REFERENCES INDIVIDUAL STATEMENTS BY MEMBERS OF THE COMMITTEE........................... Arthur C. Guyton, 81 Christine Stevens, 84 APPENDIXES A. 1896 Report of the National Academy of Sciences..... B. Curricula Vitae of Committee Members............... C. Invited Speakers at Committee Meetings INDEX ........ .47 64 68 . 75 .81 .89 ...93 96 - . 98

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Preface One of the most difficult issues to confront biological scientists, as well as the society withm which they work, ~ that of the use of laboratory animals in biomedical and behavioral research. What is the ethical relationship of investigators to the animate they use? How may we balance society's desire for the beneficial outcomes of research with the need to protect animate that generally must be used to yield those outcomes? Are there truly effective alternative methods to the use of animals or are these available methods mamly complementary? Are regulations concerning appropriate care of animals too lenient or too strict? The questions "e neither easy to mower nor are they new. In 1896, the National Academy of Sciences issued a statement in which it Termed the need to use animal ~ medical research in a letter to United States Senator Jacob H. Ginger (Appendix A). The question arose because of concerns about the treatment of animals in research, and the issues did not differ greatly from those being raised today. Yet the debate and activity have intensified recently. Research laboratories have been raided to "liberates animals. The National Institutes of Health has issued sanctions against several institutions for lack of full adherence to animal care regulations. Researchers, who have often failed to present persuasively the case for animal use in research to the public and to politicians, now are becorn~ng increasingly anxious about the limitations placed on their research. .. V11

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V111 PREFACE Books have appeared presenting the argument that the ~rights" of animals must be considered equal to those of humans. In September 1985, the National Research Council, through its Commission on Life Sciences and with the collaboration of the In- stitute of Medicine, appointed a committee to examine concerns about animal use and treatment, benefits derived by humans and animals from research with animals, and current regulatory and self- regulatory guidelines for animal care and use. Care was taken to ensure that the committee membership included scientists from wicle range of disciplines, as well as nonscientists involved in animal welfare, law, and ethics. The diverse backgrounds and interests of the committee provided an opportunity for a wide range of views on the issues to be presented. However, it also meant that on several of these issues it was not possible for the committee to reach unanim- ity, for example, on the uses of pound animate and coverage of rats, mice, birds, and farm animals used ire biomedical research under the Animal Welfare Act. The committee was asked to focus on the use of laboratory animals in research; other uses in testing and education were to be addressed less intensively. This report is the result of the comm~ttee's efforts. The committee met 10 times to collect information, interview knowledgeable persons, and discuss the issues. One meeting was a public forum in which the committee heard a spectrum of views from animal welfare groups, scientists, and anyone else who wished to share their information or opinions. More than- 200 persons at- tended and over 50 individuals representing 40 organizations made oral presentations. In addition, written statements were received from individuals and organizations who did not attend the public meeting. In the course of its work, the committee also invited to other of its meetings about 20 persons who could add to its informa- tion on government regulatory and research goad, the philosophies underlying opinions on the appropriateness of animal use, the status of the development of alternative methods to the use of animals, and the experience of other countries in the use of animals ant} the regu- lation thereof. The committee benefited from the wisdom of all these contributors ~d acknowledges its gratitude for their willingness to assist in this study. The committee had hoped to draw on the results of a new survey of laboratory animal use by the Institute of Laboratory Animal Resources of the National Research Council. Cor~tractual difficulties

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PREFACE 1X postponed this survey; thus, discussions of the numbers of animals used are based on other data. The comrn~ttee organized itself to address its charge by forming three subcommittees societal issues, on regulatory issues, and on scientific msues. The draft reports of these three sections were discussed by the entire comrn~ttee as it formed its conclusions and recommendations and cleveloped this final report. No committee dealing with an issue so emotionally charged as this, as diverse In background, and displaying such a vast difference of opinion about its topic could be expected to come easily to a consensus. The issues profoundly affect the performance of scientific research, but they are not themselves scientific. Individual opinion, life experience, and worI3view play a large part in determining how any individual approaches the topic. The committee members strove to put aside their personal interests and to address the overarch- ing principal issues in a dispassionate manner. The consensus, as expresser} in the conclusions and recommendations of this report, is evidence that the committee was reasonably successful. After discus- sion on some issues, conclusions were reached that, following further debate, were changed. All had their say, but nevertheless some mem- bers wanted to make individual statements. Included at the end of this report are two such statements. These may be useful to help the reader appreciate the depth of feeling and range of individual opin- ions that exist on this matter among interested people. They also indicate that on some of the issues surrounding the use of laboratory animals, the differences of opinion are too great for a consensus to be reached at this time. Some fee] that the timing of this assignment was inopportune. The scientific community has had little time to work with and adjust to the new regulations that govern animal research, which makes it difficult to assess the impact of the regulatory framework. However, most feel that there is no ideal moment to assess the use of laboratory animals, for, as history has demonstrated, this issue has been under active consideration for well over a century. For example, in the intervening years since the National Academy of Sciences issued its statement in 1896 on the use of laboratory animals, the level of public interest has varied, but the issues and concerns have never disappeared. We do not expect that this report will end debate about the use of animals in biomedical and behavioral research. That discussion in its modern form has been ongoing for more than a century and

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x PREFACE is almost continuously at a critical point. We believe, however, that the report provides a carefully reasoned statement on the msues. It also provides a point of departure for further discussion on how to use anneals appropriately, while recognizing and being sensitive to the concerns of Al segments of our society. The committee thanks those who have contributed to its work. We are grateful to all who shared their views with us at our public meeting and to those who accepted our invitation to provide infor- mation at other committee meetings. A list of this latter group is included as Appendix C. We appreciate the information on the leg- islative and regulatory framework affecting animal research that was provided by Marcia D. Brody, who served as a consultant. We wish especially to recognize the efforts of the stab of the Commission on Life Sciences who were instrumental in organizing this effort ant} In working with the committee throughout the effort. John Burrm was a positive influence ant} a strong ant] steady guide through the National Research Council report process. June Ewing provided valuable assistance in many areas, and Alvin Lazen brought wisdom and insight. Steve Olson edited the report. The information provided by Wayne Grogan and Dorothy Greenhouse of the NRC's Institute of Laboratory Animal Resources was of great value to us. Barbara FiIner of the Institute of Medicine staff also provided useful insights. Mary Frances Walton's cheerful assistance made our work go more easily and our attendance at meetings more enjoyable. Mar- garet Fulton prepared this manuscript, patiently making the changes required with each revision. We thank them Ad. Norman Hackerman, Chairman Committee on the Use of I,aboratory Animals in Biomedical and Behavioral Research