Institutional Administrator''s Manual for Laboratory Animal Care and Use

EXECUTIVE SUMMARY 1.1 QUALITY SCIENCE 5 1.2 LEGAL REQUIREMENTS 7 1.3 REQUIREMENTS OF FUNDING AGENCIES 8 1.4 LIABILITIES AND RISKS 8 PART 2 COMPONENTS OF A QUALITY ANIMAL CARE AND USE PR

U.S DEPARTMENT OF

HEALTH AND HUMAN SERVICES

Public Health Service

National Institutes of Health

NIH Publication No 88-2959

Prepared by the

Editorial Committee of Institutional Administratorsand Laboratory Animal Specialists for the

Henry M Jackson Foundation Advancement

of Military Medicine, Uniformed Services

University of the Health Sciences

Institutional

Administrator's Manual for

Laboratory

Animal Care

and Use

The Advisory Committee/Editorial Board extends their appreciation and thanks to Mrs.Jacqueline C Mosely, for her superb administrative support during development of thismanual, and to the numerous institutional administrators and laboratory animal specialistswho contributed their time and expertise in reviewing the various versions of the manuscript

Advisory Committee/Editorial Board

Vice President for Development

and University Relations

Vice Chancellor for Graduate

Studies and Research

Professor of Physiology and

Milton S Hershey Medical Center

Pennsylvania State University

P.O Box 850

Hershey, PA 17033

Dr Franklin M LoewDean, School of Veterinary Medicine Tufts University

200 Westboro RoadNorth Grafton, MA 01536

Dr David J RamsaySenior Vice Chancellor for Academic AffairsUniversity of CaliforniaSan Francisco, CA 94143

Dr Alvin W SmithProfessor of Veterinary MedicineOregon State University

College of Veterinary MedicineCorvallis, OR 97331

Dr James O StevensAssociate Dean for Research AffairsColorado University School ofMedicine Health Science CenterP.O Box C290

4200 E 9th AvenueDenver, CO 80262

Page No EXECUTIVE SUMMARY

1.1 QUALITY SCIENCE 5 1.2 LEGAL REQUIREMENTS 7 1.3 REQUIREMENTS OF FUNDING

AGENCIES 8 1.4 LIABILITIES AND RISKS 8

PART 2 COMPONENTS OF A QUALITY ANIMAL

CARE AND USE PROGRAM 11

2.1 THE RESEARCH TEAM 13

2.2 POLICIES, PROCEDURES, RESOURCES AND FACILITIES 14

PART 3 KEY ASPECTS OF A QUALITY ANIMAL

CARE AND USE PROGRAM 15

3.1 LINES OF RESPONSIBILITY AND AUTHORITY 17 3.2 THE INSTITUTIONAL ANIMAL

CARE AND USE COMMITTEE (IACUC) 18

APPENDICES AND TABLES

APPENDIX A - FREQUENTLY ASKED QUESTIONS

ABOUT ANIMAL CARE AND USE PROGRAMS 29 A.1 How shall institutional administrators

gather data to evaluate the quality

of the animal care and use program? 31

A.3 How can professional staff be encouraged

to support the animal care and use

program? 33

A.4 Why does the animal care and use program

seem to cost so much? 34

A.5 What is the United States Department of

Agriculture (USDA) and its role in

enforcing the Federal Animal Welfare Act? 34

A.6 What is the impact of the Freedom of

Information Act? 35

A.7 What is the concept of "animal rights?" 36

Page No 3.3 POLICIES AND PROCEDURES FOR

VETERINARY CARE AND ANIMAL

3.3.1 Facilities and Resources 22

3.3.2 Training Programs 22

3.3.3 Occupational Health Programs 24

3.3.4 Communicating With The Public 24

Page No APPENDIX B - LAWS AND GUIDELINES

B.2 U.S Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing

B.5 The NIH Guide for the Care and

B.6 Good Laboratory Practice Regulations 45

B.8 Guide for the Care and Use of Agriculture Animals in Agricultural Research and

of Laboratory Animal Care (AAALAC) 52 C.4 Institute of Laboratory Animal

C.5 American College of Laboratory Animal

C.6 American Association for Laboratory

C.7 American Veterinary Medical Association

C.8 National Association for Biomedical Research (NABR) and Foundation for

Page No.

APPENDIX D - OCCUPATIONAL HEALTH PROGRAM

D.1 History and Physical Examinations 59

D.3 Monitoring and Immunization Schedules 60

D.5 Occupational Health Professional 61

APPENDIX E

E.1

- SELF-EVALUATION OUTLINE

APPENDIX F - ACRONYMS OF ORGANIZATIONS AND

REGULATORY REFERENCES INCLUDED

TABLE 1 - INSTITUTIONAL ANIMAL CARE AND USE COMMITTEES 73

EXECUTIVE SUMMARY

This booklet entitled "Institutional Administrator's Manual for Laboratory Animal Care andUse" (referred to as the "Manual") is a concise guide for institutional administrators who superviselaboratory animal care and use programs at their institutions

A quality program is critical for quality science There are ethical, legal, and public relationsreasons for ensuring that such programs meet contemporary standards and guidelines for animaluse The Public Health Service Policy on Humane Care and Use of Laboratory Animals (referred to asthe PHS Policy), the U.S Department of Agriculture's (USDA) Animal Welfare Regulations and theNational Academy of Science's National Research Council's, the Guide for the Care and Use ofLaboratory Animals (Guide), contain the standards and requirements which impact most significantly

on institutional animal care and use programs These requirements center around the establishment

of Institutional Animal Care and Use Committees (IACUCs) with defined responsibilities andauthorities for protocol review, training programs, specifications for caging systems, requirementspertaining to veterinary care and surgical procedures, and the establishment of occupational healthprograms

No program can be successful unless personnel using or caring for laboratory animals arewell qualified by training or experience Lines of authority, policies, and procedures for animal careand use programs are to be set forth in writing, well understood, and implemented by all personsinvolved

Pitfalls to avoid are: absence of clear lines of authority and responsibility; administrativecomplacency; failure to inform and assure employees not involved in animal care or use that thereare appropriate programs to safeguard animal welfare; failure to establish procedures to ensureadministrative awareness of the status of the programs; resolution of disputes without necessarypertinent data; and, in academic institutions, ignoring resistance on the part of some individuals toparticipate in programs involving the use of animals

Costs for animal care and use programs have escalated considerably over the last severaldecades Nevertheless, adequate funds for operation of sound animal care and use programs must

be budgeted by research institutions

There are numerous regulations and information sources which should be familiar topersonnel who manage animal care and use programs These are cited and described throughoutthe Manual and in Appendix B

Institutional administrators who are responsible for animal care and use programsshould find this Manual of value In brief, it attempts to answer the following general questions:

"What constitutes a quality animal care and use program?"

"What is necessary to meet ethical, legal, and granting agency requirements for laboratory animal care and use?"

"How shall an institution evaluate the quality of its animal care and use

PART 1

INSTITUTIONAL INTERESTS

3

PART 1 - INSTITUTIONAL INTERESTS

1.1 QUALITY SCIENCE

1.2 LEGAL REQUIREMENTS

1.3 REQUIREMENTS OF FUNDING AGENCIES 1.4 LIABILITIES AND RISKS

PART 1 INSTITUTIONAL INTERESTS 1.1 QUALITY SCIENCE

Quality science demands quality animal care! Since the goal of biomedical research is goodscience, it is within the self-interest of all research institutions to have a good animal care and useprogram In research involving animals, the most significant variables are the animals themselves.There are multiple factors unrelated to the experimental design which can influence an animal'sphysiological and behavioral status (see Figure 1 entitled, "Non-experimental Factors InfluencingAnimal Physiology and Behavior," page 6); therefore, it is imperative that these factors be criticallycontrolled to minimize data variability These controls can best be accomplished with a wellmanaged, high quality animal care and use program

5

1.2 LEGAL REQUIREMENTS

Contemporary laws and guidelines require that animal experimentationprecede human application of new medical procedures, drugs, and devices (See,for example, Declaration of Helsinki, Appendix B, Section B.1, page 41) and thatsound animal care and use programs be implemented by institutions usinglaboratory animals The U.S Government Principles (Appendix B, Section B.2,page 41) provide an ethical framework within which Federal agencies andinstitutions that receive Federal support are to operate when dealing with issuespertaining to the use of laboratory animals The Federal Animal Welfare Act,along with its implementing regulations, mandates minimal standards oflaboratory animal care These standards apply to nearly all academic andresearch institutions and are enforced by the United States Department ofAgriculture (USDA) through on-site inspections, most of which are unannounced(for details see Appendix A, Section A.5, page 34, entitled "What is the UnitedStates Department of Agriculture (USDA) and its role in enforcing the FederalAnimal Welfare Act," and Appendix B, Section B.3, page 42, entitled "FederalAnimal Welfare Act")

For those institutions which receive funding from the Public HealthService (PHS), including the National Institutes of Health (NIH), additionalrequirements must be met Guidelines mandated by The Health ResearchExtension Act of 1985 (P.L 99-158) are incorporated in the PHS Policy on theHumane Care and Use of Laboratory Animals (PHS Policy, Appendix B, SectionB.4, page 42) An example of the additional requirements set forth by the PHSPolicy, as contrasted to the Federal Animal Welfare Act, is that institutions mustplace on file in the NIH's Office for Protection from Research Risks (OPRR) anapproved Animal Welfare Assurance document detailing their commitment togood animal care and use before they can receive PHS funds The PHS Policy alsorequires institutions to follow the recommendations of the Guide (for details, seeAppendix B, Section B.5, page 44) in order to be eligible to receive PHS funds toconduct activities involving animals

There are other Federal laws which may pertain to specific research and academic programs, depending upon the type of work being

7

done and the species being used Selected examples of these laws are outlined in Appendix B, Sections B.6 and B.7, pages 45-46.

In addition to Federal laws, regulations, and guidelines there are an increasing number ofstate and local statutes which affect an institution's research and academic programs involving theuse of laboratory animals Institutional administrators should ensure that procedures are in place toenable them to remain cognizant of and compliant with state and local laws and regulations thatmay affect their institution's programs

1.3 REQUIREMENTS OF FUNDING AGENCIES

Governmental agencies other than the PHS (e.g., the National Science Foundation), andmany non-governmental funding agencies (e.g., the American Heart Association), may imposeadditional requirements on animal care and use Since each agency's requirements may be different,institutional procedures should be in place to assure that these requirements are known and thatthey are met

1.4 LIABILITIES AND RISKS

The public is concerned with issues involving the use of animals in research, testing, andeducation In particular, there is growing apprehension by the public as a whole, and legislativerepresentatives at all levels, about the use of animals in what some perceive to be inhumane orunnecessary activities Any institution which uses laboratory animals must not only operate a soundprogram, but be prepared to be publicly accountable for the program in which animals are involved

Administrators are well advised to take all necessary steps to assure that visitors,employees, and students are fully aware of the institution's dedication to quality of the animal careand use program In-house procedures for surfacing and addressing concerns should be establishedand publicized This will help reduce misconceptions and

misinformation that could lead to adverse publicity, employee dissatisfaction, or even litigation.

Finally, it is possible that an institution using laboratory animals may encounter publicrelations difficulties even though it has a quality animal care and use program and even though itsemployees and students are fully informed For this reason, it is imperative that procedures bedeveloped which enable institutional administrators to be continually informed of the factspertaining to their organization's animal care and use programs so that they can be confident thattheir programs are of high quality, and can accurately respond on short notice to inquiries

9

PART 2

COMPONENTS OF A QUALITY ANIMAL CARE

AND USE PROGRAM

11

2.1.3 Animal Care Staff

2.2 POLICIES, PROCEDURES, RESOURCES, AND FACILITIES

PART 2 COMPONENTS OF A QUALITY ANIMAL CARE AND USE PROGRAM

2.1 THE RESEARCH TEAM

A quality animal care and use program requires the integrated support of many persons,including the institutional officials, the investigators and their research technicians, veterinarians,and the animal care staff Regulations and guidelines governing the use of laboratory animals apply

to all persons involved in animal use, including institutional officials, animal users (investigators andstudents), and animal care providers

2.1.1 Institutional OfficialsSustained and visible support from institutional officials is absolutely essential to establishingand maintaining a high quality animal care and use program They are in positions to influenceinstitutional priorities They can assure that sufficient monetary and personnel resources areallocated to the institution's program A high priority for animal care and use requirements on thepart of institutional officials can result in direct benefits in terms of resource availability, as well as inmany critically important indirect benefits, for example, a rapid response to facility problems byfacility engineers

13

2.1.3 Animal Care StaffThe animal care staff, from the director to the animal care technicians, are the persons whowork most directly with the experimental animals They must be dedicated to providing qualityanimal care and use support and should be well qualified, by training or experience, to handle, andminister to the animals in their care They should be knowledgeable about the requirements for thespecies involved, as well as about any special requirements imposed by specific research, testing, orteaching programs.

2.2 POLICIES, PROCEDURES, RESOURCES, AND FACILITIES

Supporting a quality animal care and use program are the personnel, policies, procedures,resources, and facilities which define the program If an institution has a dedicated, knowledgeable,and interactive staff, it is likely that it will also develop the policies, procedures, resources, andfacilities required to support a quality program With a dedicated staff, less than optimal facilitiesmay be overcome by implementing policies and procedures that encourage sound animal care anduse Although policies and procedures will be different for each institution; they should bedocumented in writing and promulgated to all persons who have responsibility for animal care anduse

PART 3

KEY ASPECTS OF A QUALITY ANIMAL CARE

AND USE PROGRAM

15

PART 3 - KEY ASPECTS OF A QUALITY ANIMAL CARE AND USE PROGRAM

3.1 LINES OF RESPONSIBILITY AND AUTHORITY 3.2 THE INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC)

3.2.1 Establishment

3.2.2 Composition

3.2.3 Responsibilities

3.3 POLICIES AND PROCEDURES FOR VETERINARY

CARE AND ANIMAL HUSBANDRY

3.3.1 Facilities and Resources

3.3.2 Training Programs

3.3.3 Occupational Health Program

3.3.4 Communicating with the Public

PART 3 KEY ASPECTS OF A QUALITY ANIMAL CARE AND USE PROGRAM

3.1 LINES OF RESPONSIBILITY AND AUTHORITY

The 1985 Amendments to the Animal Welfare Act include the provision that the "Secretary[of Agriculture] shall require that each research facility establish at least one [Institutional AnimalCare and Use] Committee" which "shall be appointed by the chief executive officer" of theinstitution In addition, the PHS Policy states that "the Chief Executive Officer [of the researchinstitution] shall appoint an Institutional Animal Care and Use Committee (IACUC)." From theseexcerpts, it is clear that there is strong regulatory emphasis on senior management levelresponsibility for animal care and use programs and on institutions managing their programs by use

of in-house oversight committees The philosophy spelled out in these two documents is clearly one

of self-regulation, with the committees working closely with the animal users, animal care staff, andthe responsible veterinarian(s) (referred to in the Animal Welfare Act as the "Attending Veterinarian")

to ensure that high quality animal care and use programs are in place A unique provision of the PHSPolicy is that institutional officials are prohibited from approving protocols or procedures which theIACUC has disapproved

Regardless of the type of institutional or managerial structure involved, the specificresponsibilities and authority of the various persons involved in the animal care and use programshould be unambiguously delineated in writing In addition, the lines of authority should be clearlyillustrated and procedures for reporting problems should be included in the written material Mostimportantly, all persons involved in the use of or caring for animals should be aware of theprocedures for the reporting

17

concerns about animal care or use (for additional information on the importance of this latter pointsee "Communicating with the Public," Part 3, Section 3.3.4., page 24).

3.2 THE INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC)

of qualified and interested individuals to an appropriate IACUC

3.2.2 CompositionThe composition of the IACUC is mandated by both the Animal Welfare Act and the PHSPolicy (for specific composition requirements, see Table 1 on page 75) While there are some minordifferences between the two documents, the intent is that the committees be composed of peoplequalified to evaluate the programs and proposals under review and who represent severalcategories of interested people, including scientists, lay persons, and those concerned withhumane care and use In all cases, someone affiliated with the institution in no way other thanservice on the IACUC, must be included in the committee's membership Institutions should ensurethat persons with expertise in the disciplines involved in local research and teaching programs areselected for service on their IACUCs

3.2.3 ResponsibilitiesThe PHS Policy requires the IACUC to evaluate the Animal Welfare Program, to identify thedeficiencies, and to make recommendations for correction of deficiencies within a reasonable time.The IACUCs are charged by the Animal Welfare Act to inspect, at least semiannually, "all animalstudy areas and animal facilities" and review, at a minimum, the condition of the animals andpractices involving pain Reports of the inspections and reviews are to be filed with the institutionand are to include a description of all "violations" and "deficiencies," as well as minority views.These reports are to be kept on file for at least three years and are subject to review by PHS officials

or by the USDA inspectors who may, in turn, forward copies to the USDA for follow-up on deficienciesand violations

The PHS Policy requires that the IACUC conduct semiannual evaluations of the institution'sprograms and inspection of its facilities Reports of these semiannual assessments are to be filedwith an "Institutional Official," specified in the Assurance, and need not be forwarded to OPRR unlessserious and continuing deficiencies are noted They are subject to review by OPRR upon request.Annual reporting requirements to OPRR include changes in program or facilities, changes in IACUCmembership, and the dates of semiannual evaluations

The Policy also mandates that the Committee "review and approve, require modifications in(to secure approval), or withhold approval" of those components of PHS funded activities related tothe care and use of animals, including any significant changes thereto In addition, the PHS Policyrequires that the IACUC be "authorized to suspend an activity involving animals" until reviewed byhigher authority and, as noted previously, the Policy prohibits institutional officials from approvingproposed activities disapproved by the Committee

In accordance with the PHS Policy, animal users must be qualified to accomplish theprocedures, and handle the animals involved in their research protocols It is the IACUC'sresponsibility to determine if individuals using certain species of animals and conducting procedures

on animals are qualified There are currently no established programs for

19

"certifying" the competence of investigators or research technicians to conduct animal procedures;thus, institutions must establish in-house criteria by which qualifications are judged Informationregarding the specific responsibilities of the IACUCs are described in Table 1, page 75.

3.3 POLICIES AND PROCEDURES FOR VETERINARY CARE AND

ANIMAL HUSBANDRY

The Animal Welfare Act requires that a veterinarian be a member of the IACUC The PHSPolicy is more specific in that it requires that the veterinarian have "training or experience inlaboratory animal science and medicine" [with] "direct or delegated program responsibility foractivities involving animals at the institution." These requirements imply that the veterinary careprogram is a key element in a satisfactory animal care and use program Furthermore, it is intendedthat the attending veterinarian be a person with some qualifications in laboratory animal medicine.Institutions which currently employ a local veterinary practitioner who might not meet suchqualifications may wish to assist the veterinarian in obtaining appropriate training through variouscontinuing education programs

The NIH Guide states that "proper management of animal facilities is essential to thewelfare of animals, validity of research data, and health and safety of the animal care staff," and, itmight be added, the health and safety of the scientists using the animals Furthermore, it is notedthat "a good husbandry program provides a system of housing and care that permits the animals togrow, mature, reproduce, and maintain good health" and results in minimizing physiologicalvariations which may affect research data In practice, a good husbandry program will include notonly good facilities and management practices but will also reflect a "caring" philosophy inapproaches taken to animal housing, handling, and use The animal care staff should be directed by

a qualified professional, such as a veterinarian or biomedical scientist with advanced training orexperience in Laboratory Animal Medicine or Science, or, in the case of small programs, a qualifiedtechnologist, with professional support provided in the form of consultants or advisors The animalcare program director must be thoroughly familiar with the various Federal and local

laws and guidelines pertaining to animal care and use programs, as well as laboratory animalscience and technology required by a contemporary program.

When attempting to evaluate the credentials of prospective animal care staff personnel,there are two peer-managed certification programs which may indicate the person's relativeknowledge and ability levels In the case of veterinarians, the American College of Laboratory AnimalMedicine (ACLAM) is a specialty board recognized by the American Veterinary Medical Association.Diplomate status in ACLAM is attained by examination In the case of animal care technologists andtechnicians, the American Association for Laboratory Animal Science (AALAS) administers acertification program with three levels of competency i.e., entry level ("Assistant Laboratory AnimalTechnician"), mid-level ("Laboratory Animal Technician"), and senior level ("Laboratory AnimalTechnologist") Certification at all three levels is by examination In addition, a number of two- andfour-year "veterinary technology" college level programs exist whose graduates have had at least anintroduction to laboratory animal science Additional information pertaining to the certificationprograms may be obtained directly from ACLAM or AALAS, and on college level programs from theAmerican Veterinary Medical Association (their addresses may be found in Appendix C, SectionsC.5., C.6., and C.7., pages 53-54)

The Animal Welfare Act contains two provisions which may significantly impact onlaboratory animal husbandry programs in the future, i.e., the Secretary of Agriculture shall establishminimum requirements for "exercise of dogs" and "a physical environment adequate to promote thepsychological well-being of [nonhuman] primates." At the time that this Manual was written,regulations implementing these two provisions had not been published; however, institutionaladministrators should assure themselves that their institution has considered these two aspects ofhusbandry

All policies and procedures which implement the institution's animal husbandry andveterinary care programs should be documented in writing and should be made available to allanimal users and other persons interested in animal care and use

21

3.3.1 Facilities and Resources

Institutional administrators must provide adequate resources for the animal care and useprogram While the costs of using animals may be partially recovered from extramural sources,through "indirect costs," reimbursement, and per diem charges, such funding may not cover allcosts Therefore, some level of "core" support from institutional funds will be necessary, especiallyfor capital improvements

The most successful resource management programs are those in which the IACUC, AnimalCare Director, and attending veterinarian work together closely as a team and receive strongsupport from institutional officials and animal users Within general guidelines specified by writteninstitutional policies, allocation of animal care and use resources should be managed by the IACUCand/or the Animal Care Director In many institutions, the IACUC reviews resource allocation policiesand procedures, such as animal space allocation and per diem fees, and recommends changes tothe institutional administrator The Animal Care Director is usually the person who manages theresources on a day-today basis, having input to policy and procedure decisions through the IACUCand, preferably, by direct advice to the institutional administrators

3.3.2 Training ProgramsThe 1985 Animal Welfare Act includes a requirement that research facilities "provide for thetraining of scientists, animal technicians, and other personnel involved with animal care andtreatment" and that the training "include instruction on:

(1) the humane practice of animal maintenance and experimentation,"

(2) research or testing methods that minimize or eliminate the use of animals or limit animal pain and distress,"

(3) utilization of the information service at the National Agricultural Library

established [under the Act]," and

(4) methods whereby deficiencies in animal care and treatment should be reported."

The PHS Policy also requires training of personnel and by stipulating that institutionsreceiving PHS funds abide by the Guide, also requires training programs, with regular participation

by research and technical staff In addition, the Guide states that:

"It is an institutional obligation to ensure that professional and technical personnel whoperform animal anesthesia, surgery, or other experimental manipulations are qualifiedthrough training or experience to accomplish these tasks in a humane and scientificallyacceptable manner Special training programs should be provided for technicians and faculty,

as well as undergraduate, graduate, and postgraduate students."

Other than the subject matter mandated by the Animal Welfare Act (see Section 3.3.2.,points 1 through 4, pages 22-23), the content of all training programs should be tailored to theinternal needs of the institution to ensure relevancy for the participants (e.g., a summary ofinstitutional animal welfare procedures) Since it is usually representative of the institutional animalcare and use communities, the IACUC is frequently the best body able to specify the content andformat which will accommodate an institution's needs

Several successful training programs have included relatively short sessions, usually devoted

to mandatory topics and other generally applicable didactic material (e.g., internal policies andprocedures), followed by longer, and usually voluntary, hands-on sessions covering specific topicssuch as handling of various species or accomplishment of specific experimental procedures In manycases, researchers have participated as teachers, providing hands-on training in specific techniqueswith which they have particular expertise Some smaller institutions, with limited in-house resources,have found it valuable to establish cooperative arrangements with neighboring institutions fortraining programs

Records of participation by personnel in training programs should be maintained, and willprobably be required by the implementation regulations for the Animal Welfare Act Amendments.Furthermore,

23

documentation of participation in the training programs may be valuable to the IACUC fordetermining qualifications of individuals wishing to work with laboratory animals.

3.3.3 Occupational Health ProgramThe Guide states that "an Occupational Health Program is mandatory for personnel whowork in laboratory animal facilities or have substantial animal contact." Depending on the animalspecies maintained and the type of activities conducted, an acceptable Occupational HealthProgram should include some or all of the following: preemployment, periodic physicals, andtermination of employment physical examinations; provisions for protective clothing and equipment;

a standardized mechanism for reporting accidents and gaining treatment; serological monitoring forexposures to specific diseases and provision of specific vaccinations; zoonoses surveillance, both asrelated to the animals and their handlers; and monitoring for exposure to potentially hazardousbiological, chemical, or physical agents (for more details, see Appendix D, page 57)

3.3.4 Communicating With The Public

It is essential that institutions using experimental animals communicate effectively withmembers of the public with interests in the use of animals in research Institutional administratorsresponsible for animal care and use programs should be well informed about their programs, as well

as animal use issues in general, so that they may be effective spokespersons for their organizations.Professional and technical staff, as well as students, are important participants in an institution'sinteractions with the public

All segments of the institutional community should be aware of the significance of the work

in which animals are used, the quality of the institution's animal care and use program, and theextent of the institution's commitment to high scientific standards through high quality animal careand use It is also important that all members of the institutional community know how to reporttheir concerns about animals internally, without fear of reprisals, and that reasonable concerns bepromptly addressed so that there is no need to go outside the institution

Some institutions have been proactive in this regard, seeking opportunities to publicize theirprograms which use laboratory animals in ways which illustrate that important work is beingaccomplished in ethical and humane ways Others have been required to respond to public inquiriesresulting from allegations of inhumane animal use or a substandard animal care and use program Insuch instances the most effective responses have ensued when the institutional spokesperson,frequently an institutional administrator, was able to address specific allegations quickly, withaccurate and factual information When public interest in animal care and use is expressed, it hasbeen shown to be helpful for institutions to have on hand prepared statements about theinstitution's policies and commitment to humane and appropriate animal care and use, the quality ofits animal care and use program (any accreditation and the extent of protocol review should bementioned, as appropriate), and brief summaries of the value and importance of any specific animaluse under scrutiny (such summaries may be a required component of protocol review procedures).All written material intended for public distribution should be written in language understandable tononscientists with high school reading abilities.

25

and

TABLES

27

APPENDIX A: FREQUENTLY ASKED QUESTIONS ABOUT ANIMAL

CARE AND USE PROGRAMS

APPENDIX B: LAWS AND GUIDELINES

APPENDIX C: SELECTED RESOURCE SOURCES

APPENDIX D: OCCUPATIONAL HEALTH PROGRAM

APPENDIX E: SELF-EVALUATION OUTLINE

APPENDIX F: ACRONYMS OF ORGANIZATIONS AND

REGULATORY REFERENCES INCLUDED IN THIS MANUAL

TABLE 1: INSTITUTIONAL ANIMAL CARE AND USE

COMMITTEES

APPENDIX A

FREQUENTLY ASKED QUESTIONS ABOUT ANIMAL CARE AND USE PROGRAMS

29

APPENDIX A - FREQUENTLY ASKED QUESTIONS ABOUT

ANIMAL CARE AND USE PROGRAMS

A.1 How shall institutional administrators

gather data to evaluate the quality

of the animal care and use programs?

A.2 What are the pitfalls?

A.3 How can professional staff be encouraged

to support the animal care and use

program?

A.4 Why does the animal care and use program seem to cost so much?

A.5 What is the United States Department of

Agriculture (USDA) and its role in

enforcing the Federal Animal Welfare Act?

A.6 What is the impact of the Freedom

of Information Act?

A.7 What is the concept of "animal rights?"

APPENDIX A

FREQUENTLY ASKED QUESTIONS ABOUT ANIMAL

CARE AND USE PROGRAMS

A.1 How shall institutional administrators gather data to evaluate the

quality of the animal care and use program?

Starting with the premise that institutional administrators are knowledgeable about what constitutes a quality animal care and use program, it is then only necessary that they be provided with accurate data about their institution's programs Such data may be obtained from a number of sources, such as:

The required Institutional Animal Care and Use Committee (IACUC) reports

Reports prepared by the United States Department of Agriculture (USDA)

inspectors

Reports prepared by site visitors from extramural granting agencies (e.g., the

National Institutes of Health (NIH))

Periodic briefings by the Animal Care Supervisor, Attending Veterinarian, and/or the Chairperson of the IACUC

Self-evaluation reports prepared at the request of the institutional administrator (see Appendix E, page 63 for a possible format)

Review of complaints or compliments relative to the animal care and use program (for this source of data to be useful, institutional procedures must be in place to document the complaints or compliments)

31