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 Administrators

and 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**

Purchase Order 263-MD-63095

Office for Protection from Research Risks

Office of Extramural Research

Office of the Director

National Institutes of Health

Bethesda, Maryland 20892

**Acknowledgements**

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

**Advisory Committee/Editorial Board**

Dr. Richard C. Simmonds

Chairman

Director of Laboratory Medicine

University of Nevada

Andersen Medical Sciences Building

Reno, Nevada 89557-0035

Dr. Roger D. Estep

Vice President for Development

> and University Relations

Howard University

5625 New Hampshire Avenue, N.E.

Washington, DC 20011

Dr. Barbara J.A. Gordon

Compliance Officer

The American University

RGCS - 303 Hamilton Building

4400 Massachusetts Avenue, N.W.

Washington, DC 20016

Dr. Barbara Hansen

Vice Chancellor for Graduate

> Studies and Research

Professor of Physiology and

> Psychology

University of Maryland Graduate

School, Baltimore

Baltimore, MD 21201

Dr. C. Max Lang

G.T. Harrell Professor and Chairman

Department of Comparative

> Medicine

Milton S. Hershey Medical Center

Pennsylvania State University

P.O. Box 850

Hershey, PA 17033

CONTENTS

+---------------+---+---------------------------------------+---------+
|               |   |                                       | **Page  |
|               |   |                                       | No.**   |
+---------------+---+---------------------------------------+---------+
| **EXECUTIVE   |   |                                       |         |
| SUMMARY**     |   |                                       |         |
+---------------+---+---------------------------------------+---------+
| **I           |   |                                       | **1**   |
| NTRODUCTION** |   |                                       |         |
+---------------+---+---------------------------------------+---------+
| **PART 1**    | * |                                       | **3**   |
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+---------------+---+---------------------------------------+---------+
| **PART 2**    | * |                                       | **11**  |
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+---------------+---+---------------------------------------+---------+
|               | * |                                       | **13**  |
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+---------------+---+---------------------------------------+---------+
|               |   | > 2.1.1 Institutional Officials       | **13**  |
+---------------+---+---------------------------------------+---------+
|               |   | > 2.1.2 Animal Users                  | **13**  |
+---------------+---+---------------------------------------+---------+
|               |   | > 2.1.3 Animal Care Staff             | **14**  |
+---------------+---+---------------------------------------+---------+
|               | * | **POLICIES, PROCEDURES,**             |         |
|               | * |                                       |         |
|               | 2 |                                       |         |
|               | . |                                       |         |
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|               | * |                                       |         |
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+---------------+---+---------------------------------------+---------+
|               |   | **RESOURCES AND FACILITIES**          | **14**  |
+---------------+---+---------------------------------------+---------+
| **PART 3**    | * |                                       | **15**  |
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+---------------+---+---------------------------------------+---------+
|               | * | **LINES OF RESPONSIBILITY**           |         |
|               | * |                                       |         |
|               | 3 |                                       |         |
|               | . |                                       |         |
|               | 1 |                                       |         |
|               | * |                                       |         |
|               | * |                                       |         |
+---------------+---+---------------------------------------+---------+
|               |   | **AND AUTHORITY**                     | **17**  |
+---------------+---+---------------------------------------+---------+
|               | * | **THE INSTITUTIONAL ANIMAL**          |         |
|               | * |                                       |         |
|               | 3 |                                       |         |
|               | . |                                       |         |
|               | 2 |                                       |         |
|               | * |                                       |         |
|               | * |                                       |         |
+---------------+---+---------------------------------------+---------+
|               |   | **CARE AND USE COMMITTEE (IACUC)**    | **18**  |
+---------------+---+---------------------------------------+---------+
|               |   | > 3.2.1 Establishment                 | **18**  |
+---------------+---+---------------------------------------+---------+
|               |   | > 3.2.2 Composition                   | **18**  |
+---------------+---+---------------------------------------+---------+
|               |   | > 3.2.3 Responsibilities              | **19**  |
+---------------+---+---------------------------------------+---------+

**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.2 What are the pitfalls? 32**
>
> **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.**

##  APPENDIX B - LAWS AND GUIDELINES

+---------------+---------------------------------------------------+---+
| **B.1**       | **Declaration of Helsinki**                       | * |
|               |                                                   | * |
|               |                                                   | 4 |
|               |                                                   | 1 |
|               |                                                   | * |
|               |                                                   | * |
+---------------+---------------------------------------------------+---+
| **B.2**       | **U.S. Government Principles for the              |   |
|               | Utilization**                                     |   |
+---------------+---------------------------------------------------+---+
|               | **and Care of Vertebrate Animals Used in          | * |
|               | Testing**                                         | * |
|               |                                                   | 4 |
|               | **Research and Training**                         | 1 |
|               |                                                   | * |
|               |                                                   | * |
+---------------+---------------------------------------------------+---+
| **B.3**       | **Federal Animal Welfare Act**                    | * |
|               |                                                   | * |
|               |                                                   | 4 |
|               |                                                   | 2 |
|               |                                                   | * |
|               |                                                   | * |
+---------------+---------------------------------------------------+---+
| **B.4**       | **Public Health Service Policy**                  | * |
|               |                                                   | * |
|               |                                                   | 4 |
|               |                                                   | 2 |
|               |                                                   | * |
|               |                                                   | * |
+---------------+---------------------------------------------------+---+
| **B.5**       | **The [NIH Guide for the Care and]{.underline}**  |   |
+---------------+---------------------------------------------------+---+
|               | ### Use of Laboratory Animals                     | * |
|               |                                                   | * |
|               |                                                   | 4 |
|               |                                                   | 4 |
|               |                                                   | * |
|               |                                                   | * |
+---------------+---------------------------------------------------+---+
| **B.6**       | **Good Laboratory Practice Regulations**          | * |
|               |                                                   | * |
|               |                                                   | 4 |
|               |                                                   | 5 |
|               |                                                   | * |
|               |                                                   | * |
+---------------+---------------------------------------------------+---+
| **B.7**       | **Other Federal Laws**                            | * |
|               |                                                   | * |
|               |                                                   | 4 |
|               |                                                   | 6 |
|               |                                                   | * |
|               |                                                   | * |
+---------------+---------------------------------------------------+---+
| **B.8**       | ### Guide for the Care and Use of Agriculture     |   |
+---------------+---------------------------------------------------+---+
|               | ### Animals in Agricultural Research and          |   |
+---------------+---------------------------------------------------+---+
|               | ### Teaching                                      | * |
|               |                                                   | * |
|               |                                                   | 4 |
|               |                                                   | 8 |
|               |                                                   | * |
|               |                                                   | * |
+---------------+---------------------------------------------------+---+
| **APPENDIX C  | **SELECTED RESOURCE SOURCES**                     | * |
| -**           |                                                   | * |
|               | **National Library of Medicine (NLM)**            | 5 |
| **C.1**       |                                                   | 1 |
|               |                                                   | * |
|               |                                                   | * |
+---------------+---------------------------------------------------+---+
| **C.2**       | **National Agricultural Library (NAL)**           | * |
|               |                                                   | * |
|               |                                                   | 5 |
|               |                                                   | 1 |
|               |                                                   | * |
|               |                                                   | * |
+---------------+---------------------------------------------------+---+
| **C.3**       | **American Association for the Accreditation**    |   |
+---------------+---------------------------------------------------+---+
|               | > **of Laboratory Animal Care (AAALAC)**          | * |
|               |                                                   | * |
|               |                                                   | 5 |
|               |                                                   | 2 |
|               |                                                   | * |
|               |                                                   | * |
+---------------+---------------------------------------------------+---+
| **C.4**       | **Institute of Laboratory Animal**                |   |
+---------------+---------------------------------------------------+---+
|               | > **Resources (ILAR)**                            | * |
|               |                                                   | * |
|               |                                                   | 5 |
|               |                                                   | 2 |
|               |                                                   | * |
|               |                                                   | * |
+---------------+---------------------------------------------------+---+
| **C.5**       | **American College of Laboratory Animal**         |   |
+---------------+---------------------------------------------------+---+
|               | > **Medicine (ACLAM)**                            | * |
|               |                                                   | * |
|               |                                                   | 5 |
|               |                                                   | 3 |
|               |                                                   | * |
|               |                                                   | * |
+---------------+---------------------------------------------------+---+
| **C.6**       | **American Association for Laboratory**           |   |
+---------------+---------------------------------------------------+---+
|               | > **Animal Science (AALAS)**                      | * |
|               |                                                   | * |
|               |                                                   | 5 |
|               |                                                   | 3 |
|               |                                                   | * |
|               |                                                   | * |
+---------------+---------------------------------------------------+---+
| **C.7**       | **American Veterinary Medical Association**       |   |
+---------------+---------------------------------------------------+---+
|               | > **(AVMA)**                                      | * |
|               |                                                   | * |
|               |                                                   | 5 |
|               |                                                   | 4 |
|               |                                                   | * |
|               |                                                   | * |
+---------------+---------------------------------------------------+---+
| **C.8**       | **National Association for Biomedical**           |   |
+---------------+---------------------------------------------------+---+
|               | > **Research (NABR) and Foundation for**          | * |
|               | >                                                 | * |
|               | > **Biomedical Research (FBR)**                   | 5 |
|               |                                                   | 4 |
|               |                                                   | * |
|               |                                                   | * |
+---------------+---------------------------------------------------+---+

> Page No.

+---------------+----------------------------------------------+-------+
| **APPENDIX    | **- OCCUPATIONAL HEALTH PROGRAM**            |       |
| D**           |                                              |       |
+---------------+----------------------------------------------+-------+
| **D.1**       | **History and Physical Examinations**        | *     |
|               |                                              | *59** |
+---------------+----------------------------------------------+-------+
| **D.2**       | **Education Program**                        | *     |
|               |                                              | *59** |
+---------------+----------------------------------------------+-------+
| **D.3**       | **Monitoring and Immunization Schedules**    | *     |
|               |                                              | *60** |
+---------------+----------------------------------------------+-------+
| **D.4**       | **Occupational Health Program**              | *     |
|               |                                              | *60** |
+---------------+----------------------------------------------+-------+
| **D.5**       | **Occupational Health Professional**         | *     |
|               |                                              | *61** |
+---------------+----------------------------------------------+-------+
| **APPENDIX    | **- SELF-EVALUATION OUTLINE**                | *     |
| E**           |                                              | *65** |
|               | **Institutional Policies**                   |       |
| **E.1**       |                                              |       |
+---------------+----------------------------------------------+-------+
| **E.2**       | **Laboratory Animal Husbandry**              | *     |
|               |                                              | *66** |
+---------------+----------------------------------------------+-------+
| **E.3**       | **Veterinary Care**                          | *     |
|               |                                              | *67** |
+---------------+----------------------------------------------+-------+
| **E.4**       | **Physical Plant**                           | *     |
|               |                                              | *67** |
+---------------+----------------------------------------------+-------+
| **E.5**       | **Special Considerations**                   | *     |
|               |                                              | *68** |
+---------------+----------------------------------------------+-------+
| **APPENDIX    | **- ACRONYMS OF ORGANIZATIONS AND**          | *     |
| F**           |                                              | *69** |
|               | #### REGULATORY REFERENCES INCLUDED          |       |
|               |                                              |       |
|               | > **IN THIS MANUAL**                         |       |
+---------------+----------------------------------------------+-------+
| **TABLE 1 -** | **INSTITUTIONAL ANIMAL CARE AND USE          | *     |
|               | COMMITTEES**                                 | *73** |
+---------------+----------------------------------------------+-------+

**EXECUTIVE SUMMARY**

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

A quality program is critical for quality science. There are ethical,
legal, and public relations reasons for ensuring that such programs meet
contemporary standards and guidelines for animal use. The Public Health
Service Policy on Humane Care and Use of Laboratory Animals (referred to
as the PHS Policy), the U.S. Department of Agriculture\'s (USDA) Animal
Welfare Regulations and the National Academy of Science\'s National
Research Council\'s, the [Guide for the Care and Use of
Laboratory]{.underline} [Animals]{.underline} ([Guide]{.underline}),
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 and authorities for protocol
review, training programs, specifications for caging systems,
requirements pertaining to veterinary care and surgical procedures, and
the establishment of occupational health programs.

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

Pitfalls to avoid are: absence of clear lines of authority and
responsibility; administrative complacency; failure to inform and assure
employees not involved in animal care or use that there are appropriate
programs to safeguard animal welfare; failure to establish procedures to
ensure administrative awareness of the status of the programs;
resolution of disputes without necessary pertinent data; and, in
academic institu­tions, ignoring resistance on the part of some
individuals to participate in programs involving the use of animals.

Costs for animal care and use programs have escalated consid­erably over
the last several decades. 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 to personnel who manage animal care and use programs. These are
cited and described throughout the Manual and in Appendix B.

####### INTRODUCTION

Institutional administrators who are responsible for animal care and use
programs should 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 program?"

In addition to answering these general questions, the Manual addresses a
number of frequently asked questions contained in Appendix A.

For purposes of this publication, the term \"laboratory animals\" refers
to vertebrate animals only.

**1**

**2**

###### **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**

**4**

**PART 1\
INSTITUTIONAL INTERESTS\
1.1 QUALITY SCIENCE**

Quality science demands quality animal care! Since the goal of
biomedical research is good science, it is within the self-interest of
all research institutions to have a good animal care and use program. 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\'s physiological and
behavioral status (see Figure 1 entitled, \"Non-experimental Factors
Influencing Animal Physiology and Behavior,\" page 6); therefore, it is
imperative that these factors be critically controlled to minimize data
variability. These controls can best be accomplished with a well
managed, high quality animal care and use program.

**5**

![](media/image1.wmf)

**6**

**1.2 LEGAL REQUIREMENTS**

> Contemporary laws and guidelines require that animal experimentation
> precede human application of new medical procedures, drugs, and
> devices (See, for example, Declaration of Helsinki, Appendix B,
> Section B.1, page 41) and that sound animal care and use programs be
> implemented by institutions using laboratory animals. The U.S.
> Govern­ment Principles (Appendix B, Section B.2, page 41) provide an
> ethical framework within which Federal agencies and institutions that
> receive Federal support are to operate when dealing with issues
> pertaining to the use of laboratory animals. The Federal Animal
> Welfare Act, along with its implementing regulations, mandates minimal
> standards of laboratory animal care. These standards apply to nearly
> all academic and research institutions and are enforced by the United
> States Department of Agriculture (USDA) through on-site inspections,
> most of which are unannounced (for details see Appendix A, Section
> A.5, page 34, entitled \"What is the United States Department of
> Agriculture (USDA) and its role in enforcing the Federal Animal
> Welfare Act,\" and Appendix B, Section B.3, page 42, entitled
> \"Federal Animal Welfare Act\").
>
> For those institutions which receive funding from the Public Health
> Service (PHS), including the National Institutes of Health (NIH),
> additional requirements must be met. Guidelines mandated by The Health
> Research Extension Act of 1985 (P.L. 99-158) are incorporated in the
> PHS Policy on the Humane Care and Use of Laboratory Animals (PHS
> Policy, Appendix B, Section B.4, page 42). An example of the
> additional requirements set forth by the PHS Policy, as contrasted to
> the Federal Animal Welfare Act, is that institutions must place on
> file in the NIH\'s Office for Protection from Research Risks (OPRR) an
> approved Animal Welfare Assurance document detailing their commitment
> to good animal care and use before they can receive PHS funds. The PHS
> Policy also requires institutions to follow the recommendations of the
> [Guide]{.underline} (for details, see Appendix B, Section B.5, page
> 44) in order to be eligible to receive PHS funds to conduct 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 of state and local statutes which affect an
institution\'s research and academic programs involving the use of
laboratory animals. Institutional administrators should ensure that
procedures are in place to enable them to remain cognizant of and
compliant with state and local laws and regulations that may affect
their institution\'s programs.

**1.3 REQUIREMENTS OF FUNDING AGENCIES**

Governmental agencies other than the PHS (e.g., the National Science
Foundation), and many non-governmental funding agencies (e.g., the
American Heart Association), may impose additional 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 that they are met.

**1.4 LIABILITIES AND RISKS**

The public is concerned with issues involving the use of animals in
research, testing, and education. In particular, there is growing
apprehension by the public as a whole, and legislative representatives
at all levels, about the use of animals in what some perceive to be
inhumane or unnecessary activities. Any institution which uses
laboratory animals must not only operate a sound program, 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 care and use program.
In­-house procedures for surfacing and addressing concerns should be
established and publicized. This will help reduce misconceptions and

**8**

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

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

**9**

**10**

**PART 2**

COMPONENTS OF A QUALITY ANIMAL CARE\
AND USE PROGRAM

11

########  PART 2 - COMPONENTS OF A QUALITY ANIMAL CARE

########  AND USE PROGRAM

> **2.1 THE RESEARCH TEAM**
>
> 2.1.1 Institutional Officials
>
> 2.1.2 Animal Users
>
> 2.1.3 Animal Care Staff

2.  **POLICIES, PROCEDURES, RESOURCES,**

**AND FACILITIES**

**12**

**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 and students), and
animal care providers.

2.1.1 Institutional Officials

Sustained and visible support from institutional officials is absolutely
essential to establishing and maintaining a high quality animal care and
use program. They are in positions to influence institutional
priorities. They can assure that sufficient monetary and personnel
resources are allocated to the institution\'s program. A high priority
for animal care and use requirements on the part of institutional
officials can result in direct benefits in terms of resource
availability, as well as in many critically important indirect benefits,
for example, a rapid response to facility problems by facility
engineers.

2.1.2 Animal Users

An animal care and use program cannot succeed without the active support
of the scientists and their research technicians. The animal users, with
their vested interests are in the best position to define the needs of
the institution\'s research, testing, and educational efforts and to
implement experimental designs and animal use procedures which will
support both quality science and humane care and use of animals.

**13**

2.1.3 Animal Care Staff

The animal care staff, from the director to the animal care technicians,
are the persons who work most directly with the experimental animals.
They must be dedicated to providing quality animal care and use support
and should be well qualified, by training or experience, to handle, and
minister to the animals in their care. They should be knowledgeable
about the requirements for the species involved, as well as about any
special requirements imposed by specific research, testing, or teaching
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, and facilities required to support a quality
program. With a dedicated staff, less than optimal facilities may be
overcome by implementing policies and procedures that encourage sound
animal care and use. Although policies and procedures will be different
for each institution; they should be documented in writing and
promulgated to all persons who have responsibility for animal care and
use.

**14**

**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

1.  **LINES OF RESPONSIBILITY AND AUTHORITY**

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

**16**

**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 \[Institutional Animal Care and Use\]
Committee\" which \"shall be appointed by the chief executive officer\"
of the institution. In addition, the PHS Policy states that \"the Chief
Executive Officer \[of the research institution\] shall appoint an
Institutional Animal Care and Use Committee (IACUC).\" From these
excerpts, it is clear that there is strong regulatory emphasis on senior
management level responsibility 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, and the 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 PHS Policy is that institutional
officials are prohibited from approving protocols or procedures which
the IACUC has disapproved.

Regardless of the type of institutional or managerial structure
involved, the specific responsibilities and authority of the various
persons involved in the animal care and use program should be
unambiguously delineated in writing. In addition, the lines of authority
should be clearly illustrated and procedures for reporting problems
should be included in the written material. Most importantly, all
persons involved in the use of or caring for animals should be aware of
the procedures for the reporting

**17**

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

**3.2. THE INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC)\
**3.2.1 Establishment

> As noted above, all research institutions which are required to be
> registered under the provisions of the Animal Welfare Act, or which
> receive PHS funds, are required by law to establish an IACUC. The
> Congress and PHS have mandated that institutions establish IACUCs to
> oversee programs of animal use with the objective that these
> committees form the foundation for effective self-regulation.
> Institutions subject to provisions of both the Animal Welfare Act and
> the PHS Policy, may establish a single IACUC, provided that the
> committee meets all requirements of both documents. Small institutions
> which have limited personnel resources may wish to consider consortium
> type arrangements with nearby organizations in order to assemble
> sufficient numbers of qualified and interested individuals to an
> appropriate IACUC.

3.2.2 Composition

> The composition of the IACUC is mandated by both the Animal Welfare
> Act and the PHS Policy (for specific composition requirements, see
> Table 1 on page 75). While there are some minor differences between
> the two documents, the intent is that the committees be composed of
> people qualified to evaluate the programs and proposals under review
> and who represent several categories of interested people, including
> scientists, lay persons, and those concerned with humane care and use.
> In all cases, someone affiliated with the institution in no way other
> than service on the IACUC, must be included in the committee\'s
> membership. Institutions should ensure that persons with expertise in
> the disciplines involved in local research and teaching programs are
> selected for service on their IACUCs.

**18**

3.2.3 Responsibilities

The PHS Policy requires the IACUC to evaluate the Animal Welfare
Program, to identify the deficiencies, 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 animal study areas and animal facilities\" and review, at a
minimum, the condition of the animals and practices involving pain.
Reports of the inspections and reviews are to be filed with the
institution and 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 deficiencies and violations.

The PHS Policy requires that the IACUC conduct semiannual evaluations of
the institution\'s programs and inspection of its facilities. Reports of
these semiannual assessments are to be filed with an \"Institutional
Official,\" specified in the Assurance, and need not be forwarded to
OPRR unless serious 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 IACUC
membership, 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 to the care and use of
animals, including any significant changes thereto. In addition, the PHS
Policy requires that the IACUC be \"authorized to suspend an activity
involving animals\" until reviewed by higher authority and, as noted
previously, the Policy prohibits institutional officials from approving
proposed activities disapproved by the Committee.

In accordance with the PHS Policy, animal users must be qualified to
accomplish the procedures, and handle the animals involved in their
research protocols. It is the IACUC\'s responsibility 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. Information regarding 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 PHS Policy is more specific in that it requires that the
veterinarian have \"training or experience in laboratory animal science
and medicine\" \[with\] \"direct or delegated program responsibility for
activities involving animals at the institution.\" These requirements
imply that the veterinary care program is a key element in a
satisfactory animal care and use program. Furthermore, it is intended
that 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 such qualifications may wish
to assist the veterinarian in obtaining appropriate training through
various continuing education programs.

The NIH [Guide]{.underline} states that \"proper management of animal
facil­ities is essential to the welfare of animals, validity of research
data, and health and safety of the animal care staff,\" and, it might be
added, the health and safety of the scientists using the animals.
Furthermore, it is noted that \"a good husbandry program provides a
system of housing and care that permits the animals to grow, mature,
reproduce, and maintain good health\" and results in minimizing
physiological variations which may affect research data. In practice, a
good husbandry program will include not only good facilities and
management practices but will also reflect a \"caring\" philosophy in
approaches 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 or
experience in Laboratory Animal Medicine or Science, or, in the case of
small programs, a qualified technologist, with professional support
provided in the form of consultants or advisors. The animal care program
director must be thoroughly familiar with the various Federal and local

**20**

laws and guidelines pertaining to animal care and use programs, as well
as laboratory animal science 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 relative knowledge and ability levels. In the
case of veterinarians, the American College of Laboratory Animal
Medicine (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 and technicians,
the American Association for Laboratory Animal Science (AALAS)
administers a certification program with three levels of competency
i.e., entry level (\"Assistant Laboratory Animal Technician\"),
mid-level (\"Laboratory Animal Technician\"), and senior level
(\"Laboratory Animal Technologist\"). Certification at all three levels
is by examination. In addition, a number of two- and four-year
\"veterinary technology\" college level programs exist whose graduates
have had at least an introduction to laboratory animal science.
Additional information pertaining to the certification programs may be
obtained directly from ACLAM or AALAS, and on college level programs
from the American Veterinary Medical Association (their addresses may be
found in Appendix C, Sections C.5., C.6., and C.7., pages 53-54).

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

All policies and procedures which implement the institution\'s animal
husbandry and veterinary care programs should be documented in writing
and should be made available to all animal 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 use program. 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 all
costs. Therefore, some level of \"core\" support from institutional
funds will be necessary, especially for capital improvements.

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

3.3.2 Training Programs

The 1985 Animal Welfare Act includes a requirement that research
facilities \"provide for the training of scientists, animal technicians,
and other personnel involved with animal care and treatment\" 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

**22**

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

The PHS Policy also requires training of personnel and by stipulating
that institutions receiving PHS funds abide by the [Guide]{.underline},
also requires training programs, with regular participation by research
and technical staff. In addition, the [Guide]{.underline} states that:

> \"It is an institutional obligation to ensure that professional and
> technical personnel who perform animal anesthesia, surgery, or other
> experimental manipulations are qualified through training or
> experience to accomplish these tasks in a humane and scientifically
> acceptable 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 the internal needs of the
institution to ensure relevancy for the participants (e.g., a summary of
institutional animal welfare procedures). Since it is usually
representative of the institutional animal care and use communities, the
IACUC is frequently the best body able to specify the content and format
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 and procedures),
followed by longer, and usually voluntary, hands-on sessions covering
specific topics such as handling of various species or accomplishment of
specific experimental procedures. In many cases, researchers have
participated as teachers, providing hands-on training in specific
techniques with which they have particular expertise. Some smaller
institutions, with limited in-house resources, have found it valuable to
establish coopera­tive arrangements with neighboring institutions for
training programs.

Records of participation by personnel in training programs should be
maintained, and will probably 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 for determining qualifications of individuals wishing to
work with laboratory animals.

3.3.3 Occupational Health Program

The [Guide]{.underline} states that \"an Occupational Health Program is
mandatory for personnel who work in laboratory animal facilities or have
substantial animal contact.\" Depending on the animal species maintained
and the type of activities conducted, an acceptable Occupational Health
Program should include some or all of the following: preemployment,
periodic physicals, and termination of employment physical examinations;
provisions for protective clothing and equipment; a standardized
mechanism for reporting accidents and gaining treatment; serological
monitoring for exposures to specific diseases and provision of specific
vaccinations; zoonoses surveillance, both as related to the animals and
their handlers; and monitoring for exposure to potentially hazardous
biological, 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 with members of the public with interests in the use of
animals in research. Institutional administrators responsible 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\'s
interactions 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 the extent of the
institution\'s commitment to high scientific standards through high
quality animal care and use. It is also important that all members of
the institutional community know how to report their concerns about
animals internally, without fear of reprisals, and that reasonable
concerns be promptly addressed so that there is no need to go outside
the institution.

**24**

Some institutions have been proactive in this regard, seeking
opportunities to publicize their programs which use laboratory animals
in ways which illustrate that important work is being accomplished in
ethical and humane ways. Others have been required to respond to public
inquiries resulting from allegations of inhumane animal use or a
substandard animal care and use program. In such instances the most
effective responses have ensued when the institutional spokesperson,
frequently an institutional administrator, was able to address specific
allegations quickly, with accurate and factual information. When public
interest in animal care and use is expressed, it has been shown to be
helpful for institutions to have on hand prepared statements about the
institution\'s policies and commitment to humane and appropriate animal
care and use, the quality of its animal care and use program (any
accreditation and the extent of protocol review should be mentioned, as
appropriate), and brief summaries of the value and importance of any
specific animal use 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 to
nonscientists with high school reading abilities.

**25**

**26**

**APPENDICES**

**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**

**28**

**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?\"**

**30**

**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**

> \-- Reports prepared by external consultants (usually only required
> when there is a perception of chronic problems with the animal care
> and use program) or peer review organizations
>
> Outside peer review of the animal care and use program by qualified
> personnel can be extraordinarily helpful in spotting problem areas
> which have been overlooked by in-house personnel. These outside
> reviews can be accomplished through contracts with private consultants
> or by participation in a voluntary accredita­tion program. At the time
> this publication was written, the only voluntary accrediting program
> in the United States is provided by the American Association for the
> Accreditation of Laboratory Animal Care (AAALAC) (for details of the
> AAALAC program, see Appendix C, Section C.3., on page 52).

##### A.2 What are the pitfalls?

> Laboratory animal science and medicine, as well as the laws and
> contemporary guidelines pertaining to laboratory animal care and use,
> are rapidly changing, leading to frequent, and often significant,
> changes. In addition, the public is expressing even stronger demands
> for accountability in programs publicly funded. These circumstances
> result in increased pressure on institutional administrators to
> re-evaluate and update their animal care and use programs at regular
> intervals. Major pitfalls to which institu­tional administrators should
> be alert are:
>
> \-- [Absence of written clear lines of authority and
> responsibility]{.underline}
>
> It is imperative that all those involved with the institution\'s
> animal care and use program understand and accept their individual and
> collective responsibilities. It must be known by all those involved
> exactly where \"the buck stops.\"
>
> \-- [Complacency]{.underline}

The concept of \"That\'s the way we have always done it, so why change
now?\" is a trap which will most likely lead to obsolescence and other
problems. Strong leadership by senior officials is a strong antidote to
complacency.

**32**

\-- [Forgetting the in-house \"community\"]{.underline}

> Ignoring the concerns of the institutional staff, or simply not having
> procedures which will permit staff to express concerns, can lead to
> frustrated employees who then seek help from extramural groups such as
> the news media.

\-- [Lack of information]{.underline}

> Institutional administrators must ensure that they will be fully
> informed about the quality and effectiveness of their animal care and
> use programs.

\-- [One-sided resolution of disputes between animal care staff and
animal users]{.underline}

> All disputes between the animal care staff and animal users must be
> fairly resolved on the merits of the case and not on the relative
> prestige or income producing abilities of the persons in conflict.

\-- [Failure to have in place clearly well-written, well-publicized
policies pertaining to the use of]{.underline}

[animals especially with regard to teaching programs]{.underline}

There is an increasingly vocal but small minority of students refusing
to take part in academic exercises involving either live or dead animals
(e.g., dissection of preserved animals in a biology class). Academic
institutions should consider having written policies on student
participation in exercises involving animals, including any available
alternatives and the potential penalties, if any, for failure to
participate. These policies should be clearly set forth in institutional
catalogs and course materials.

**A.3 How can professional staff be encouraged to support the animal
care and use program?**

> The best way for institutional administrators to encourage
> professional staff support of the animal care and use program is by
> their own, highly visible support. Combining this with positive
> incentives, such as the use of discretionary funds to \"underwrite\"

**33**

> improved animal care systems and the incorporation of investi­gator
> input into program management policies and procedures, will usually be
> sufficient to obtain support from animal users.

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

> Coincident with other costs of biomedical research and education, the
> costs of animal care and use programs are escalating. Just as the
> costs for biomedical equipment and library subscriptions have risen
> sharply over the last several decades, so too have the costs for
> animals, animal transportation, and animal housing. The animal care
> facility is an extension of the research laboratory, its
> sophistication should be consistent with the changing requirements of
> modern science.
>
> Modern research requires the use of very sophisticated animal models
> which require more specialized care. The need for more finely tuned
> control of ambient environmental conditions required by these animals,
> the ability to detect even more subtle physiological changes (e.g.,
> those caused by slight variations in husbandry conditions), and
> increasingly high standards contained in regulations and policies,
> have increased the cost of animal use significantly.
>
> As husbandry and veterinary care requirements have become more
> complex, specially trained animal care professionals and techni­cians
> have become a necessity, and these persons command higher salaries
> than those traditionally paid for animal care providers. For example,
> the relatively inexpensive galvanized cage systems of yesteryear have
> been replaced with the consider­ably more expensive, and durable,
> plastic, stainless steel, or aluminum systems of today.
>
> **A.5 What is the United States Department of Agriculture (USDA) and
> its role in enforcing the**
>
> **Federal Animal Welfare Act?**
>
> The Federal Animal Welfare Act (7 U.S.C. 2131) is enforced by
> inspectors from the Animal and Plant Health Inspection Service (APHIS)
> of the U. S. Department of Agriculture (USDA) through.

**34**

> unannounced on-site inspections. The Animal Welfare Act requires all
> registered facilities to be inspected at least annually and more often
> if necessary to resolve deficiencies. The inspectors have broad powers
> to inspect facilities used to house \"Act species\" (i.e., dogs, cats,
> nonhuman primates, guinea pigs, hamsters, rabbits, marine mammals, and
> other warm-blooded animals specified by the Secretary of Agriculture)
> and review reports of the IACUC. Penalties for violations of the Act
> include fines and imprisonment and, in conjunction with other Federal
> funding agencies, loss of Federal funds.
>
> The USDA inspector will leave an inspection report entitled, \"USDA
> Form 18-8,\" after each visit. It is then the institution\'s right to
> note any rebuttal comments to any alleged deficiencies or violations
> directly on the form, or on a separate page attached to the report, at
> the time of the inspection. Since all inspection reports are available
> to the general public through the Freedom of Information Act (see
> \"What is the Impact of the Freedom of Information Act?,\" Appendix A,
> Section A.6, page 35), it may be very beneficial to ensure that any
> deficiency or violation which is thought to be unjustified by
> institutional personnel be rebutted at the time of the inspection,
> preferably directly on the form. A follow-up rebuttal may not be
> released with an inspection report if it is not made a part of that
> inspection record.
>
> All registered institutions must submit an annual report detailing
> their use of species covered
>
> by the Act. Failure to submit the report may be grounds for legal
> penalties.

**A.6 What is the impact of the Freedom of Information Act (FOIA)?**

> The Freedom of Information Act (FOIA, 5 U.S.C. 552) compels Federal
> agencies to release official documents except in a few specific cases,
> mostly pertaining to national security, Federal investigations, and
> personnel information. The provisions of this Act apply to both the
> USDA Federal investigations and all components of the Public Health
> Service (PHS); thus, nearly all material pertaining to animal care and
> use programs which are held by these agencies are obtainable through
> FOIA requests,

**35**

> including the USDA inspection reports and the PHS Assurance
> Statements. The only exceptions to this are in cases of ongoing
> investigations into alleged violations of the Animal Welfare Act (AWA)
> or PHS Policy, in which case all relevant documents are protected from
> release; but only until the investigation is completed, at which time
> the entire case file may be subject to release. Because of the FOIA,
> and in order to protect the institution, its programs, and its
> employees, it is prudent for institutions to ensure that information,
> beyond that required, is not provided to any Federal agency. In
> addition, it would be prudent to ensure that where information is
> available in Federal files, e.g., the USDA inspection reports, that
> any rebuttal material or information is made an integral part of the
> files.

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

> Until the mid-1970s, the philosophical foundation of the
> antivivisection movement was [generally]{.underline} one of animal
> \"welfare.\" However, since the mid-1970s the movement\'s
> philosophical foundation appears to have moved appreciably toward
> assertion of animal \"rights.\" The concept of animal \"rights\" is
> variously defined but, in general, it can be understood to mean that
> sentient animals, especially warm-blooded vertebrates, have a
> \"right\" not to be used for research, i.e., such animals are not to
> be used as means to human ends. The more radical animal \"rights\"
> believers advocate the total abolition of all use of nonhuman animals
> for human benefit, e.g., for food, clothing, sport, or companionship.
>
> The importance of this change in the philosophical foundation of the
> antivivisection movement lies in the fact that traditional animal
> \"welfare\" advocates can accept a high quality animal care and use
> program while animal \"rights\" advocates cannot. In other words,
> animal \"welfare\" advocates and scientists can usually find agreeable
> solutions to questions about how animals are to be cared for and used
> in biomedical research, testing, and education programs since both may
> be truly interested in the humane treatment of the animals. However,
> it would appear highly unlikely that extreme animal \"rights\"
> advocates and scientists can

**36**

> reach agreement in the foreseeable future, as the only acceptable
> position for the \"rightist\" is total abolition of such use of
> animals. Because of this significant change in the philosophical
> foundation of the antivivisection movement, it is unlikely that the
> public concern over the use of animals in biomedical research,
> testing, and education programs will diminish markedly in the near
> future.
>
> It should be noted, however, that by mandating research programs
> involving animals, the Congress of the United States, speaking on
> behalf of the people, has taken a firm stand against the animal
> \"rights\" advocates who would prohibit all use of animals for
> research purposes.
>
> Furthermore, by refusing to incorporate animal \"rights\" language in
> any Federal legislation the Congress has withheld public approval for
> the animal \"rights\" philosophy.

**37**

**38**

**APPENDIX B**

**LAWS AND GUIDELINES**

**39**

##  APPENDIX B - LAWS AND GUIDELINES

> **B.1 Declaration of Helsinki**
>
> **B.2 U.S. Government Principles for the**
>
> **Utilization and Care of Vertebrate**
>
> **Animals Used in Testing, Research,**
>
> **and Training (Principles)**
>
> **B.3 Federal Animal Welfare Act**
>
> **B.4 Public Health Service Policy**
>
> **B.5 The NIH [Guide for the Care and]{.underline}**
>
> **[Use of Laboratory Animals]{.underline}**
>
> **B.6 Good Laboratory Practice Regulations**
>
> **B.7 Other Federal Laws**
>
> **B.8 [Guide for the Care and Use of Agriculture]{.underline}**
>
> **[Animals in Agricultural Research and]{.underline}**
>
> **[Teaching]{.underline}**

**40**

**APPENDIX B**

**LAWS AND GUIDELINES**

**B.1 Declaration of Helsinki**

> I. Basic Principles; Paragraph 1 - \"Biomedical research involving
> human subjects must conform to generally accepted scientific
> principles and should be based on adequately performed laboratory
> [and]{.underline} [animal]{.underline} (emphasis added)
> experimentation and on a thorough knowledge of the scientific
> literature.\" \[Adopted by the 18th World Medical Assembly, Helsinki,
> Finland, 1964 and as revised by the 29th World Medical Assembly,
> Tokyo, Japan, 1975. Revised in Budapest, 1983.\]

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

**Testing, Research, and Training (Principles)**

> The Interagency Research Animal Committee, with representatives from
> all Federal agencies which fund biomedical research, developed a set
> of nine principles which are to be adhered to by institutions and
> persons using animals in Federally funded programs. The
> [Principles]{.underline} are listed in the back of the [Public Health
> Service (PHS) Policy]{.underline} document (see Appendix B, Section
> B.4., \"Public Health Service Policy,\" on page 42). The preamble to
> the [Principles]{.underline} states:
>
> \"The development of knowledge necessary for the improvement of the
> health and well-being of humans as well as other animals requires
> [in]{.underline} [vivo]{.underline} experimentation with a wide
> variety of animal species. Whenever U.S. Government agencies develop
> requirements for testing, research, or training procedures involving
> the use of vertebrate animals, \[these\] principles shall be
> considered; and whenever these agencies actually perform or sponsor
> such procedures, the responsible Institutional Official shall ensure
> that these principles are adhered to.\"

**41**

**B.3 Federal Animal Welfare (AWA) Act**

> The Federal Animal Welfare Act (7 U.S.C. 2131 et seq.) was passed in
> 1966 and has been amended three times since then; the latest in 1985
> (P.L. 99-198 entitled, \"The Improved Standards for Laboratory Animals
> Act\"). The law applies to all institutions which use warm-blooded
> species included in the Act (dogs, cats, nonhuman primates, guinea
> pigs, hamsters, rabbits, marine mammals, livestock species used for
> biomedical research, and warm-blooded wild mammals) or specified by
> the Secretary of Agriculture (thus far, the Secretary has not
> specified that any species be added to the list). In practice, the
> vast majority of institutions which use warm-blooded vertebrate
> animals in biomedical research, testing, and education programs are
> covered by the Federal law and must register with the USDA. All
> registered institutions are subject to annual inspections by USDA
> officers (more frequently if significant deficiencies are noted) and
> must have an Institutional Animal Care and Use Committee (see Table 1
> for Committee composition and responsibilities, pages 75-­77). Copies
> of the current implementation regulations and any pending revisions
> can be obtained from:
>
> Animal and Plant Health Inspection Service
>
> United States Department of Agriculture
>
> Room 756, Federal Building
>
> 6505 Belcrest Road
>
> Hyattsville, MD 20782
>
> \(301\) 436-7833
>
> **B.4 Public Health Service (PHS) Policy**
>
> The PHS Policy on the Care and Use of Laboratory Animals has been in
> existence for many years and was significantly revised in 1985 and,
> most recently, in 1986. The September 1986 revision includes
> provisions mandated by Federal law (P.L. 99-158, Health Research
> Extension Act of 1985). All institutions which receive PHS funds for
> \"research, research training, and biological testing activities\"
> involving the use of vertebrate animals, including funds

**42**

from the National Institutes of Health, are required to adhere to the
provisions of the PHS Policy, regardless of the species of vertebrate
animal used.

A major provision of the PHS Policy is the requirement for institutions
to file an \"Animal Welfare Assurance\" with the Office for Protection
from Research Risks (OPRR). Before any PHS funds may be awarded to an
institution it must have an approved Assurance on file with OPRR. The
Assurance must include a detailed description of the institution\'s
animal care and use program and implementing procedures for the program,
as well as documentation of institutional commitment to adherence to the
PHS Policy. In addition, an annual report to OPRR is required indicating
any changes in the animal care and use program as reported in the
Assurance, dates of semiannual Institutional Animal Care and Use
Committee (IACUC) reports required by the Policy, gain or loss of
American Association for Accreditation of Laboratory Animal Care
(AAALAC) Accreditation, and any minority views on the findings in
required reports. Animal Welfare Assurance documents constitute
institutional policy and must be promulgated to all persons who
participate in the animal welfare program of the institution.

The PHS Policy also requires institutions using animals and submitting
research grant proposals to have an IACUC (see Table 1, on page 75 for
composition and responsibilities of the committee) to ensure that the
following five points have been addressed in the applications, with
sufficient detail to permit evaluation, and to verify IACUC approval:

\(1\) The species and number of animals required, including
justification for the numbers proposed.

\(2\) The rationale for the use of living animals in general, and of the
specific animal model system

proposed in particular.

\(3\) A description of how the animals will be housed and used and what
procedures they will be involved in.

**43**

> \(4\) A description of any procedures which will be utilized to
> minimize pain and distress.
>
> \(5\) A description of the methods of euthanasia which will be used.
>
> Copies of the current Policy may be obtained from:
>
> Office for Protection from Research Risks (OPRR)
>
> National Institutes of Health
>
> 9000 Rockville Pike
>
> Building 31, Room 5B59
>
> Bethesda, MD 20892
>
> \(301\) 496-7163

**B.5 The NIH [Guide for the Care and Use of Laboratory
Animals]{.underline} [(Guide)]{.underline}**

> The [Guide for the Care and Use of Laboratory Animals]{.underline}
> (the [Guide,]{.underline} NIH Publication 85-23) is the most
> influential set of guidelines pertaining to laboratory animal care and
> use in existence. The [Guide]{.underline} is intended to be a source
> of \"information on common laboratory animals housed under a variety
> of circumstances\" which will \"assist institutions in caring for and
> using laboratory animals in ways judged to be professionally and
> humanely appropriate.\" All persons involved with administering an
> animal care and use program should be fully familiar with the
> provisions of the [Guide]{.underline}. It was first published in 1963
> and has been revised five times, most recently in 1985. The contents
> of the [Guide]{.underline} are developed by a panel of veterinary and
> other scientific experts assembled by the Institute of Laboratory
> Animal Resources (ILAR), Commission on Life Sciences, National
> Research Council, and the National Academy of Sciences and represent
> contemporary consensus on appropriate standards for Animal Care and
> Use Programs.
>
> The contents of the [Guide]{.underline} include sections covering
> Institutional Policies, Laboratory Animal Husbandry, Veterinary Care,
> Physical Plant, and Special Considerations. In addition, there are
> four Appendices which include a Selected Bibliography, a listing of

**44**

> Professional and Certifying Laboratory Animal Science Organiza­tions, a
> selected list of Federal Laws Relevant To Animal Care and Use, the PHS
> Policy, and the U.S. Government Principles.
>
> The [Guide]{.underline} is published by NIH and copies are available
> from OPRR (for address, see page 44).

**B.6 Good Laboratory Practice (GLP) Regulations**

> Both the Food and Drug Administration (21 C.F.R. 58) and the
> Environmental Protection Agency (40 C.F.R. 160 for Pesticide Program
> and 40 C.F.R. 792 for Toxic Substances Program) enforce Federal
> regulations requiring the use of \"Good Laboratory Practices\" (GLPs).
> The provisions of these regulations contain specific requirements for
> the care and housing of laboratory animals as well as for
> documentation of such care and use. These regulations apply only to
> projects being accomplished which will result in data supporting new
> drug or medical devices and new pesticide or toxic substances
> applications, respectively. Institutions conducting research projects
> which fall into these categories should obtain (a) copy(ies) of the
> appropriate GLP(s) and ensure that the provisions thereof are
> followed. Copies of the current GLPs may be obtained from:
>
> Food and Drug Administration Bioresearch Program Office Parklawn
> Building, Room 12A-55 HFC-230
>
> 5600 Fishers Lane Rockville, MD 20857 (301) 443-2390
>
> Environmental Protection Agency
>
> Office of Pesticides and Toxic Substances Laboratory Data Integrity
> Programs
>
> 401 M Street, SW
>
> Washington, DC 20460 (202) 382-7830

**45**

##### B.7 Other Federal Laws

> **a. Marine Mammal Conservation and Protection Act**
>
> The Marine Mammal Conservation and Protection Act (16 U.S.C. 1361)
> applies to any program maintaining marine mammals in captivity or
> interacting with marine mammals in the wild. The Act includes
> provisions for housing, handling, and care of marine mammals which are
> in addition to the marine mammal standards included in the Animal
> Welfare Act (AWA). Any institution with programs involving marine
> mammals should be familiar with the provisions of this Act. Copies of
> the current law and regulations may be obtained from:
>
> Department of the Interior
>
> Fish and Wildlife Service
>
> 18th & C Streets, NW
>
> Washington, DC 20240
>
> \(202\) 343-5634

b.  **Lacey and Endangered Species Acts (and Convention on International
    Trade in**

**Endangered Species (CITES)**

> The Lacey Act (16 U.S.C. 701) applies to programs involving the
> interstate transport of wild animals captured in any of the 50 states.
> The Endangered Species Act (16 U.S.C. 1531) applies to specified
> species of animals, sometimes from specified geographic areas, which
> have been determined to be \"endangered\" or \"threat­ened.\" The
> provisions of the Endangered Species Act may apply to captive bred, as
> well as wild-caught, individuals of the listed species. Institutions
> using wild caught or nondomestic animals, including most species of
> nonhuman primates, should be familiar with the provisions of these
> Acts and the latest version of the CITES. Institutions procuring or
> shipping animals in internation­al trade may also be impacted by the
> provisions of the Convention on International Trade in Endangered
> Species (CITES, 27 U.S.T. 1087, TIAS 8249) if the species involved are
> covered by the provisions of the Convention. Copies of the current
> laws,

**46**

regulations, and Convention may be obtained from the Fish and Wildlife
Service of the

Department of the Interior at the address listed in Appendix B, under
Section B.7.a., on page

46\.

c.  **Guidelines and Regulations for Recombinant DNA, Biohazardous
    Agents, Hazardous**

> **Chemicals, Radiation Producing Equipment, Radioactive Materials, and
> Controlled**
>
> **Substances**

Various Federal and state agencies, issue a number of guidelines, and in
some cases

regulations (e.g., Nuclear Regulatory Commission regulations pertaining
to radioisotope

possession and use), which impact upon an institution\'s animal care and
use program.

Whenever such materials or equipment are involved in an institution\'s
research, testing, or

education programs involving animals, the appropriate institutional
safety or assurance

officials and committees should be aware of their use and of all
appropriate Federal and state

regulations and guidelines. It is also especially important that the
animal care supervisor be

knowledgeable about any special requirements for animal housing or
handling and ensure that

appropriate safety precautions are implemented by all persons working
with the animals

involved. Some selected sources for information about Federal
regulations and guidelines listed

below are:

> **Carcinogens,** National Institutes of Health
>
> **Chemicals,** Division of Safety
>
> **and R-DNA:** Building 31, Room 1C02
>
> Bethesda, MD 20892
>
> \(301\) 496-1357
>
> **Infectious** Centers for Disease Control
>
> **Agents:** Office of Biosafety
>
> Atlanta, GA 30333
>
> \(404\) 329-3883

**47**

> **Isotopes:** U.S. Nuclear Regulatory Commission
>
> Medical, Academic, and Commercial Use
>
> Safety Branch
>
> WF1, Mail Stop 6H06
>
> Washington, DC 20555
>
> \(202\) 492-0640
>
> **Radiation,** Food and Drug Administration
>
> **and Medical** Center for Devices and Radiological
>
> **Devices:** Health

HFZ-311

> 1390 Piccard Drive
>
> Rockville, MD 20850
>
> \(301\) 427-1165
>
> **Safety and** Department of Labor

**Health:** Occupational Safety and Health

Administration

200 Constitution Ave, NW

Washington, DC 20210

\(202\) 523-7075/8063

**B.8 [Guide for the Care and Use of Agriculture Animals in Agricultural
Research and Teaching]{.underline}**

> While not covered by any law, regulation, or Federal policy, the care
> and use of agricultural animals for agricultural research not funded
> by Federal agencies is of concern to a number of organizations and
> institutions. As a result of these concerns, the agricultural
> community appointed a Consortium for Developing a [Guide for the Care
> and Use of Agricultural Animals in]{.underline} [Agricultural Research
> and Teaching]{.underline} ([Agri-Guide]{.underline}). The First
> Edition of the [Agri-Guide]{.underline} was published in March 1988
> and is available from the American Dairy Science Association, 309 West
> Clark Street, Champaign, IL 61820. Institutions using livestock
> species for agricultural research will find this new set of guidelines
> especially useful.

**48**

**APPENDIX C**

**SELECTED RESOURCE SOURCES**

**49**

**APPENDIX C - SELECTED RESOURCE SOURCES**

> **C.1 National Library of Medicine (NLM)**
>
> **C.2 National Agricultural Library (NAL)**
>
> **C.3 American Association for the Accreditation**
>
> **of Laboratory Animal Care (AAALAC)**
>
> **C.4 Institute of Laboratory Animal**
>
> **Resources (ILAR)**
>
> **C.5 American College of Laboratory Animal**
>
> **Medicine (ACLAM)**
>
> **C.6 American Association for Laboratory**
>
> **Animal Science (AALAS)**
>
> **C.7 American Veterinary Medical**
>
> **Association (AVMA)**
>
> **C.8 National Association for Biomedical**
>
> **Research (NABR) and Foundation for**
>
> **Biomedical Research (FBR)**

**50**

> **APPENDIX C**

**SELECTED RESOURCE SOURCES**

**C.1 National Library of Medicine (NLM)**

> The National Library of Medicine (NLM) is currently providing computer
> searches under the key phrase \"Animal Welfare\" through its MEDLINES
> services. In addition, NLM has a listing of training materials which
> may be useful for institutions which are developing in-house training
> programs. Additional information on NLM services may be obtained from:
>
> Dr. Fritz Gluckstein
>
> National Library of Medicine
>
> 8600 Rockville Pike
>
> Bethesda, MD 20894
>
> \(301\) 496-6097

**C.2 National Agricultural Library (NAL)**

> As required by the 1985 Amendments of the Federal Animal Welfare Act
> (AWA), the National Agricultural Library (NAL) has established a
> reference service for materials which document \"alternative\"
> procedures to animal use in biomedical research, testing, and
> teaching, as well as for the development of in-house training
> programs. In addition, an on-line electronic bulletin board and mail
> service has been initiated at the NAL. Informa­tion on NAL programs and
> materials may be obtained from:

Ms. Jean Larson

National Agricultural Library

Beltsville, MD 20705

\(301\) 344-1215

**51**

**C.3 American Association for the Accreditation of Laboratory Animal
Care (AAALAC)**

> The American Association for Accreditation of Laboratory Animal Care
> (AAALAC) was established in 1965 as a cooperative effort between
> several professional societies and has achieved a reputation for the
> quality of its accreditation program. The program involves an initial
> site visit followed by revisits at least every three years. AAALAC
> chooses qualified site visitors to evaluate animal care and use
> programs and AAALAC Accreditation is considered by most people,
> including the PHS, an indication that an institution has and is
> committed to maintaining an overall high quality Animal Care and Use
> Program. Information about the AAALAC program may be obtained from:
>
> Dr. Albert E. New
>
> Executive Director
>
> American Association for Accreditation of
>
> Laboratory Animal Care
>
> 9650 Rockville Pike
>
> Bethesda, MD 20814
>
> \(301\) 571-1850

**C.4 Institute of Laboratory Animal Resources (ILAR)**

> The Institute of Laboratory Animal Resources (ILAR), National Research
> Council, National Academy of Sciences, currently provides information
> on sources of species and strains of animals; publishes various
> standards for nomenclature, housing, and handling of laboratory
> animals; accomplishes national surveys on the use of animals in
> biomedical research, testing, and education; and sponsors symposia and
> reports on various specific topics of interest (e.g., the use of
> \"alternatives\" to animals). Information on current activities may be
> obtained from:

**52**

> Dr. Thomas L. Wolfle
>
> Director
>
> Institute of Laboratory Animal Resources
>
> National Research Council
>
> National Academy of Sciences
>
> 2101 Constitution Ave, NW
>
> Washington, DC 20418
>
> \(202\) 334-2590

**C.5 American College of Laboratory Animal Medicine (ACLAM)**

> The American College of Laboratory Animal Medicine (ACLAM) is a
> veterinary specialty board. Members, or Diplomates, are veterinarians
> who have met specific training/experience criteria and have
> successfully completed an examination in Laboratory Animal Medicine
> and Science. Additional information about the ACLAM may be obtained
> from:
>
> Dr. C. Max Lang
>
> Secretary Treasurer
>
> American College of Laboratory Animal Medicine
>
> Department of Comparative Medicine
>
> The Milton S. Hershey Medical Center
>
> The Pennsylvania State University
>
> P.O. Box 850
>
> Hershey, PA 17033
>
> \(717\) 531-8462

**C.6 American Association for Laboratory Animal Science (AALAS)**

> The American Association for Laboratory Animal Science (AALAS) is a
> professional society with membership open to anyone interested in the
> field of Laboratory Animal Science. The Association administers a
> national certification program for laboratory animal care technicians
> and managers. Certification is obtained by successful completion of
> examinations given on a nationwide basis. AALAS also produces and
> sells or loans training materials pertaining to laboratory animal
> care, handling, and housing. Information about the AALAS may be
> obtained from:

**53**

> Mr. Donald Keene
>
> Executive Director
>
> American Association for Laboratory Animal Science
>
> 70 Timber Creek Drive, Suite 5
>
> Cordova, TN 38018
>
> \(901\) 754-8620

**C.7 American Veterinary Medical Association (AVMA)**

> The American Veterinary Medical Association (AVMA) is a professional
> society with membership open to veterinarians and selected other
> persons who have made significant contributions to Veterinary
> Medicine. The AVMA accredits college-level programs in veterinary
> technology, many of which provide training relevant to laboratory
> animal science. In addition, the Association produces and distributes
> audiovisual materials which are useful for laboratory animal training
> programs. Information about AVMA programs may be obtained from:
>
> American Veterinary Medical Association
>
> 930 North Meacham Road
>
> Schaumberg, IL 60196
>
> \(800\) 248-2862

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

**Biomedical Research (FBR)**

> The National Association for Biomedical Research (NABR) is an
> association of institutional members interested in supporting the
> appropriate use of animals in biomedical research. NABR engages in
> numerous lobbying efforts and provides its member institutions with
> legislative updates and public education materials. Individual
> memberships are not accepted.
>
> The Foundation for Biomedical Research (FBR) is a nonprofit,
> educational organization established for the purpose of developing and
> distributing educational materials for use in Laboratory Animal
> Science and Public Awareness Programs. In addition, FBR

**54**

provides its contributors with up-to-date information on current issues
involving the use and

care of laboratory animals. Individual contributions are accepted. Both
organizations may be

reached at the following address:

National Association for Biomedical Research

\[Foundation for Biomedical Research\]

818 Connecticut Ave, NW

Washington, DC 20006

NABR - (202) 857-0540

FBR - (202) 457-0654

**55**

**56**

**APPENDIX D**

**OCCUPATIONAL HEALTH PROGRAM**

**57**

**APPENDIX D - OCCUPATIONAL HEALTH PROGRAM**

> **D.1 History and Physical Examinations**
>
> **D.2 Education Program**
>
> **D.3 Monitoring and Immunization Schedules**
>
> **D.4 Occupational Health Program**
>
> **D.5 Occupational Health Professional**

**58**

> **APPENDIX D**

**OCCUPATIONAL HEALTH PROGRAM**

The [Guide for the Care and Use of Laboratory Animals]{.underline} (the
[Guide]{.underline}, NIH Publication 85-23) states that \"an
occupational health program is mandatory for personnel who work in
laboratory animal facilities or have substantial animal contact.\" The
components of an acceptable Occupational Health Program include:

##### D.1 History and Physical Examinations

> a\. A medical history and preemployment physical examination should be
> completed prior to anyone being allowed to work with animals. Persons
> with evidence of diseases transmissible to animals (e.g.,
> tuberculosis), allergies to animals, or who may be immune deficient
> should be discouraged, or prohibited, from working with animals.
>
> b\. Periodic physical examinations should be completed where
> circumstances warrant, e.g., routine exposure to potentially hazardous
> situations such as working with nonhuman primates, in high noise
> areas, or with ionizing radiation. These periodic examinations should
> be customized as appropriate for the circum­stances, e.g., audiometry
> for persons working in high noise areas.
>
> c\. Special physical examinations may be necessary due to nonroutine
> exposure to a hazardous situation, e.g., a bite from a rhesus monkey
> possibly infected with simian herpes virus. These examinations should
> be limited to procedures necessary for monitoring the patient for the
> health hazard involved.

**D.2 Education Program**

> An ongoing educational program should be in place which ensures that
> all persons working in an Animal Care and Use Program are fully aware
> of any potential hazards involved in their work, e.g., physical
> dangers involved with the species in use (such as bites, scratches,
> and allergies), zoonotic organisms, chemical

**59**

> and radiation hazards, and general safety hazards (such as slippery
> floors, use of live steam in sanitization and sterilization equipment,
> and lifting of heavy objects). In addition, the education program
> should ensure that all persons working with animals know how to
> recognize, prevent, and treat occupational hazards.

**D.3 Monitoring and Immunization Schedules**

> Appropriate monitoring and immunization schedules should be adopted.
>
> a\. Monitoring should include biannual PPD tuberculin skin testing
> (only for persons with nonhuman primate contact and who have been PPD
> negative), rabies titers (for persons immunized for rabies and who are
> exposed to wild mammals or random source dogs and cats), Q-fever
> titers (for persons exposed to sheep, goats, cattle, and pigs), and,
> where possible, titers for any infectious agents involved in the
> research.
>
> b\. Serum samples should be collected for banking prior to employment,
> at periodic intervals during employment, and at termination of
> employment. Samples should be stored at liquid nitrogen temperatures
> for reference use in the case of suspected zoonotic illness and should
> be kept permanently.
>
> c\. An immunization program should be an integral part of the
> Occupational Health Program and should include a mandatory requirement
> for vaccination for tetanus (preemployment and at 10 year intervals),
> along with voluntary vaccinations for rabies (for persons exposed to
> wild mammals and random source dogs and cats) and research specific
> organisms as appropriate (e.g., hepatitis B, vaccinia virus
> constructs, and tularemia).

**D.4 Occupational Health Program**

> The Occupational Health Program should include procedures for
> monitoring and detecting occupationally caused illness or injury.
> Records should be kept, and maintained permanently, of work

**60**

> assignments, exposure to hazardous agents, injuries (especially animal
> bites and scratches), and unusual illnesses.

##### D.5 Occupational Health Professional

> A qualified Occupational Health Professional should review the
> Occupational Health Programs and records on a regular basis.

**61**

**62**

**APPENDIX E**

**SELF-EVALUATION OUTLINE**

**63**

**APPENDIX E - SELF-EVALUATION OUTLINE**

**E.1 Institutional Policies**

**E.2 Laboratory Animal Husbandry**

**E.3 Veterinary Care**

**E.4 Physical Plant**

**E.5 Special Considerations**

**64**

> **APPENDIX E**
>
> **SELF-EVALUATION OUTLINE**
>
> NOTE TO READER: The following outline is based on the NIH [Guide for
> the Care and Use of Laboratory Animals]{.underline}
> ([Guide]{.underline}) and is intended only to illustrate the types of
> questions which should be included in any self-­evaluation of an animal
> care and use program. It is not intended to be all-inclusive and
> persons responsible for such an evaluation should be fully familiar
> with the provisions of the [Guide]{.underline} and modify this outline
> accordingly as appropriate for their institution. In all cases,
> descriptions called for in the outline should be concluded with
> statements as to whether or not the component described meets the
> provisions of the Federal Animal Welfare Act and the
> [Guide]{.underline}. Institutional administrators reviewing the
> self-evaluation reports also should be fully familiar with the
> provisions of the [Guide]{.underline} so that they are able to judge
> the adequacy of their animal care and use programs.
>
> **E.1 Institutional Policies**
>
> 1\. Is there a written statement of institutional commitment to
> appropriate and humane animal care and use? If yes, indicate where it
> has been published and attach a copy.
>
> 2\. What procedures are there for reviewing and monitoring the care
> and proposed, and ongoing, use of animals in institutional programs?
> Are there mechanisms for suspending questionable procedures or
> projects until reviewed by the Institutional Animal Care and Use
> Committee (IACUC) or a senior administrative official? If yes,
> describe.
>
> 3\. Describe the veterinary care program. Include a description of the
> provisions for emergency, after-hours care, and how an investigator
> would obtain such care. What are the responsibilities and authority of
> the attending veterinarian?

**65**

> 4\. Describe the qualifications of the principal animal care managers
> and indicate how the qualifications of the animal users are
> determined.
>
> 5\. Describe the Occupational Health Program for persons working with
> animals, including any requirements pertaining to the use of personal
> protective equipment and personal hygiene procedures. Describe the
> criteria by which it is determined who will be included or excluded
> from the Occupational Health Program.
>
> 6\. Describe any institutional policies pertaining to the use of
> hazardous agents in laboratory animals.
>
> 7\. Describe any institutional policies pertaining to long-term
> restraint or multiple surgical procedures.

##### E.2 Laboratory Animal Husbandry

> 1\. Provide a general description of each animal housing facility,
> including its present state of repair. Indicate what minor and major
> repairs, if any, are required. Include a discussion of any new
> facilities, or major remodeling efforts, which are necessary to bring
> the animal care and use program into compliance with current laws,
> regulations, or guidelines.
>
> 2\. Describe the routine housing arrangements for each species being
> used in institutional programs. Include types of cages and bedding,
> caging densities, provisions for feeding and watering (including on
> weekends and holidays), environmental conditions (e.g., temperature,
> humidity, and light cycles), sanitation schedules, and methods of
> identification and record keeping.
>
> 3\. Describe any special housing arrangements required by specific
> research programs.
>
> 4\. Summarize the provisions for emergency, weekend, and holiday care.

**66**

> **E.3 Veterinary Care**
>
> 1\. If not done in Section E.1, describe the overall veterinary care
> program.
>
> 2\. Describe the Preventive Medicine Program. Include discus­sions of
> animal procurement, quarantine, and species separation procedures and
> policies intended to minimize risks of introduc­ing, or spreading,
> diseases into, or among, institutional colonies.
>
> 3\. Describe the procedures and policies for disease surveillance,
> diagnosis, treatment, and control.
>
> 4\. Describe the policies pertaining to the use of anesthetics,
> analgesics, and tranquilizers for elimination or minimization of
> animal pain and distress. Include specific discussions on any
> procedures approved by the IACUC which involve unrelieved animal pain
> or distress.
>
> 5\. Describe the policies and procedures pertaining to surgery and
> post-surgical care. Include specific discussions about the level of
> asepsis required for which kinds of surgical procedures, in which
> species of animals, and about the adequacy of facilities used for
> survival surgery.
>
> 6\. Describe the methods of euthanasia approved for use with each of
> the species involved in institutional programs.
>
> **E.4 Physical Plant**
>
> 1\. Indicate what the physical relationship is between the animal
> facilities, support facilities, research laboratories, and teaching
> laboratories.
>
> 2\. Describe what functional areas are included in the animal
> facilities or are available for use by animal care or use personnel.
>
> 3\. If not included with the general description of facilities
> provided in Part E.2.1., on page 66, provide descriptions of the

**67**

> following aspects of the animal facilities: corridor size and
> construction, animal room door design and condition, animal room
> surfaces (floors, walls, ceilings), lighting (windows, light fixtures,
> light intensity, timers), temperature and humidity control,
> ventilation, power (including provisions for power outages), noise
> control, storage space, equipment and supply sanitation capabil­ities,
> and provisions for monitoring environmental parameters.
>
> 4\. Describe any facilities used for aseptic surgery.
>
> 5\. Describe any facilities used for animal research involving
> hazardous agents (e.g., infectious organisms, carcinogenic or toxic
> chemicals, and radioisotopes).
>
> 6\. Although not specifically addressed in the [Guide]{.underline} or
> in the [PHS Policy]{.underline}, security of the animal facilities and
> research laboratories is an area of distinct importance. Each research
> facility needs a precise and deliberate approach to dealing with the
> risk of physical damage to facilities, records, and equipment, or
> pilferage of animals or research records. Describe any existing
> security systems or procedures and note any known deficiencies. If
> resources are available to make a formal risk assessment report,
> attach a copy.

##### E.5 Special Considerations

> 1\. Describe the procedures used to monitor and assure animal genetic
> and nomenclature accuracy.
>
> 2\. Describe the policies, procedures, and activities involving
> animals not currently covered by the Federal Animal Welfare Act,
> Public Health Service Policy, or the [Guide]{.underline}.
>
> 3\. Describe what Federal, state, and local laws, regulations, and
> guidelines affect the institution\'s Animal Care and Use Programs. Are
> any special permits or licenses required and have they been obtained?
> Do all of the institution\'s policies and procedures comply with all
> applicable laws, regulations, and guidelines? If not, describe the
> discrepancies.

**68**

**APPENDIX F**

**ACRONYMS OF ORGANIZATIONS AND\
REGULATORY REFERENCES INCLUDED IN THIS MANUAL**

**69**

**70**

**APPENDIX F**

**ACRONYMS OF ORGANIZATIONS AND**

**REGULATORY REFERENCES INCLUDED IN THIS MANUAL**

**[ACRONYM]{.underline} [ORGANIZATION OR REGULATORY
REFERENCE]{.underline}**

**AAALAC** **American Association for the Accreditation of Laboratory
Animal Care**

**AALAS American Association for Laboratory Animal Science**

**ACLAM American College of Laboratory Animal Medicine**

**AGRI-GUIDE [Guide for the Care and Use of Agricultural Animals in
Agricultural Research]{.underline}**

**[and Teaching]{.underline}**

**APHIS Animal and Plant Health Inspection Service**

**AVMA American Veterinary Medical Association**

##### AWA Animal Welfare Act

**CITES Convention on International Trade in Endangered Species**

**FBR Foundation for Biomedical Research**

**FOIA Freedom of Information Act**

**GLP Good Laboratory Practice**

**GUIDE [Guide for the Care and Use of Laboratory Animals]{.underline}
IACUC Institutional Animal Care and Use Committee**

**ILAR Institute of Laboratory Animal Resources**

**71**

**LACEY Lacey and Endangered Species Act**

**MANUAL Institutional Administrator\'s Manual for Laboratory Animal
Care and Use**

**NABR National Association for Biomedical Research**

**NAL National Agricultural Library**

**NAS National Academy of Science**

**NIH National Institutes of Health**

**NLM National Library of Medicine**

**NRC National Research Council**

**OPRR Office for Protection from Research Risks**

**PHS Public Health Service**

**PHS POLICY Public Health Service Policy on Humane Care and Use of
Laboratory Animals**

**PRINCIPLES U.S. Government Principles for the Utilization and Care of
Vertebrate Animals**

**Used in Testing, Research, and Training**

**USDA United Stated Department of Agriculture**

**72**

**TABLE 1**

**INSTITUTIONAL ANIMAL CARE AND\
USE COMMITTEES**

**73**

**TABLE 1 - INSTITUTIONAL ANIMAL CARE AND USE COMMITTEES**

**1. Appointing Official**

**2. Membership**

**3. Responsibility**

**74**

**TABLE 1**

Table 1 entitled \"Institutional Animal Care and Use Committees," is
designed to compare provisions of the Federal Animal Welfare Act and the
Public Health Service Policy regarding the areas of Appointing
Authority, Membership, and Responsibilities.

**INSTITUTIONAL ANIMAL CARE AND USE COMMITTEES**

**[FEDERAL ANIMAL WELFARE ACT]{.underline} [PUBLIC HEALTH SERVICE
POLICY]{.underline}**

**1. [APPOINTING AUTHORITY]{.underline}**

\"Chief Executive Officer\" of the \"Chief Executive Officer\" of the

research facility. research facility.

**2. [MEMBERSHIP]{.underline}**

> Not less than five members

Not less than three members with \"qualified through experience and

\"sufficient ability to assess animal expertise\" to oversee the

care, treatment, and procedures.\" institution\'s animal program,

At least one member shall be a facilities, and procedures. The

veterinarian and at least one shall committee membership shall

not be affiliated with the include at least one veterinarian

institution other than for service (\"with training or experience in

on the Committee (and shall not Laboratory Animal Science and

be a member of the immediate Medicine\"), one practicing

family of a person who is scientist (\"experienced in research

affiliated with the institution) and involving animals\"), one

who is to \"provide representation nonscientist, and one person not

for general community interests affiliated with the institution

in the proper care and treatment except for service on the

of animals.\" If the Committee Committee (and who is not a

consists of more than three member of the immediate family

members, no more than three of a person affiliated with the

shall be from the same institution). An individual who

administrative unit of the meets the requirements of more

institution. than one of the categories may

> fulfill more than one requirement.

**75**

**3. [RESPONSIBILITIES]{.underline}**

As pertain to PHS supported

\- At least semiannually inspect activities:

all animal study areas and animal

facilities. - At least semiannually inspect

> animal facilities using the [Guide]{.underline}

\- During the inspections, review: as a basis for evaluation.

(a) \"practices involving pain to

> animals\" and (b) the condition - In addition to inspecting the
>
> of animals. facilities, the Committee is

expected to review the

\- File inspection reports with the \"institution\'s program for humane

institution (must be retained for care and use\" during these twice

at least three years and be yearly reviews.

available for inspection of USDA

inspectors); reports must (a) be - Submit reports of the

signed by a majority of the semiannual evaluations with the

Committee members involved in \"Institutional Official\" (person

the inspection, (b) include reports signing NIH Assurance Letter),

of violations or deficiencies such reports to be \"maintained

pertaining to the standards and by the institution and made

deviations from approved available to OPRR upon request\"

procedures, (c) include any (retention period not given);

minority views, and (d) include reports must (a) be updated at

any other information pertinent least every six months, (b)

to the activities of the Committee. include a description of the

\"nature and extent of the

\- Notify the \"administrative institution\'s adherence to the

representative of the research [Guide]{.underline} and \[the PHS\]
Policy and

facility of any deficiencies or must identify specifically any

deviations from the provisions of departures from the provisions of

\[the\] Act\" and, if after an the [Guide]{.underline} and \[PHS\]
Policy, and

opportunity for correction, the must state the reasons for each

deficiencies or deviations remain departure, (c) distinguish

uncorrected, notify USDA/APHIS between \"significant\" and \"minor\"

(in writing) and the funding deficiencies (significant being any

Federal agency of such which threatens the health or

deficiencies and deviations. safety of the animals), (d) include

a plan for correcting

**76**

**3. [RESPONSIBILITIES (Cont\'d)]{.underline}**

\- Federal facilities will establish each deficiency, and (e) identify

committees as specified above any element of the institution

and which will function as noted holding AAALAC Accreditation.

above except that they will report

uncorrected deficiencies or - Notification of the \"institutional

deviations to the head of the official\" as per previous

Federal agency involved and not paragraph.

to USDA/APHIS.

\- \"Review concerns involving the

> care and use of animals at the
>
> institution.\"
>
> \- Make recommendations
>
> regarding all aspects of the
>
> institution\'s animal program,
>
> facilities, or personnel training.
>
> \- Review and approve, require
>
> modifications in (to secure
>
> approval), or withhold approval
>
> of activities, or proposed
>
> significant changes to previously
>
> approved, activities supported by
>
> PHS funds. All approved
>
> activities must be rereviewed at
>
> least every three years.

\- Suspend a previously approved

activity involving animals if it is

determined that the activity is

not being conducted in

accordance with the Federal

Animal Welfare Law, the [Guide]{.underline},

or the PHS Policy.

**77**

**78**

**NOTES**

**79**

**NOTES**

**80**

**NOTES**

**81**

**NOTES**

**82**