ILAR Journal Online, Volume 38(1) 1997: Unusual Mammalian Models

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ILAR Journal V38(1) 1997
Unusual Mammalian Models

Special Report

The 1996 Guide for the Care and Use of Laboratory Animals
J. Derrell Clark, Gerald F. Gebhart, Janet C. Gonder, Michale E. Keeling, Dennis F. Kohn

INTRODUCTION

The Guide for the Care and Use of Laboratory Animals (the Guide) was first published in 1963 under the title Guide for Laboratory Animal Facilities and Care and was revised in 1965, 1968, 1972, 1978, and 1985. More than 400,000 copies have been distributed since it was first published, and it is widely accepted as a primary reference on animal care and use. In 1991, an ad hoc committee appointed by the Institute of Laboratory Animal Resources (ILAR) recommended that the Guide be revised. The Committee to Revise the Guide for the Care and Use of Laboratory Animals (the Committee) (see roster p 47) was appointed in 1993 by the National Research Council; its 15 members included research scientists, veterinarians, and nonscientists representing bioethics and the public's interest in animal welfare.

Purpose and Goals

The purpose of the Guide, as expressed in the charge to the Committee to Revise the Guide, is to assist institutions in caring for and using animals in ways judged to be scientifically, technically, and humanely appropriate. The Guide is also intended to assist investigators in fulfilling their obligation to plan and conduct animal experiments in accord with the highest scientific, humane, and ethical principles. The recommendations are based on published data, scientific principles, expert opinion, and experience with methods and practices that have proved to be consistent with high-quality, humane animal care and use. The introduction to the first Guide stated that "If the Guide is to serve usefully, it must be a living document, subject to change with changing conditions and new information." This philosophy has been supported and implemented in subsequent Guides.

The Guide is written for a diverse group of national and international institutions and organizations, and its guidelines are applied to many species of animals in varied settings, types of institutions, and uses (for example, facilities can range from a Biosafety Level 4 containment facility to a farm pasture). Guidelines and standards for a specific animal species, in a specific setting, in a specific institution, and for a specific use may be relatively easy to write. However, such narrowly focused guidelines or standards may be inappropriate, harmful, ineffective, or counterproductive when applied to other species or situations. Because guidelines for animal care and use with broad applicability are needed, the Guide often makes general recommendations, the details of which must be addressed locally with specific standard operating procedures, decisions by animal care personnel and users, and institutional animal care and use committee (IACUC) approvals. The Introduction and Chapter I of the Guide emphasize the important role of the IACUC in implementing the guidelines and identifies its authority, responsibility, and discretion in this role.

The '85 Guide (NRC 1985) has been a good and useful document and did not need to be completely rewritten. The Committee's goals were to (1) update the document to make the '96 Guide current in compliance areas, state-of-the-art techniques and equipment, and science; and (2) use performance standards rather than engineering standards whenever appropriate.

Process

Since 1961, the process of developing the Guide has been independent of governmental influence. There has been a concerted effort, first by the Animal Care Panel and later by the National Academy of Sciences (NAS), to appoint unbiased, objective, balanced, expert committees. Each committee has been charged with the task of formulating appropriate guidelines, taking into consideration such critical factors as species of animals, research uses of animals, settings in which animals are used, necessary resources, and ethical considerations. This process has been very effective and has served the scientific community and animals used in research well.

Much of the information in earlier guidelines was based on experience, professional judgment, and arbitrary decisions rather than objective peer-reviewed data. To some extent this is still true. After the first Guide, each revised edition has been based on preceding versions and expanded and updated as appropriate based on factors improving research quality and animal well-being. Some aspects of recent Guides have changed very little from earlier editions. Previous Guides were excellent documents for their times, have served us well, and are tributes to the leadership and vision of early writers.

The care and use of animals evoke strong emotions and opinions. It is unrealistic to expect that everyone will agree with every aspect of the Guide. No person or committee could write a document that is universally acceptable. Committees are used so that different ideas and approaches can be presented, discussed, and resolved. The Guide is a consensus document resulting from the discussions and decisions of a committee composed of individuals with differing ideas, perspectives, and approaches.

The '96 Guide Committee did not deliberate in a vacuum. We received extensive input from the general public, animal welfare advocates, and the scientific community through public hearings, other oral comments, and several hundred written comments. We relied on scientific literature (assisted by the bibliographic search services of the Animal Welfare Information Center) in our deliberations. We solicited information from experts on selected topics.

Unfortunately, in many areas of the Guide, objective peer-reviewed data to substantiate specific practices may be lacking, contradictory, or ambiguous. Available data may not be applicable to the diverse settings covered by the Guide. For example, while some data is available on a given topic involving very specific circumstances applicable only to a very limited set of research settings, its application to general guidelines for all research settings could be problematic. The Committee used carefully chosen wording when making recommendations in such areas, and empowered the IACUC to use performance standards to interpret and adapt recommendations to specific settings. In updating the guidelines the Committee spent considerable effort to add explanatory material including references to assist the reader in understanding the rationale behind recommendations thereby making it easier to apply them in specific settings.

Regulations, Policies, and Guidelines

Three documents affect the conduct of animal care and use: the Guide, the Animal Welfare Regulations or AWRs (9 CFR 1-3), and the Public Health Service Policy on Humane Care and Use of Laboratory Animals or PHS Policy (PHS 1986). The Guide predates the Animal Welfare Act (AWA) and the PHS Policy. The first Guide was published in 1963; the first AWA regulations were released in 1966; and the first National Institutes of Health (later PHS) policy was issued in 1971. The AWA (implemented by the U.S. Department of Agriculture or USDA) and PHS Policy (implemented by the National Institutes of Health, Office for Protection from Research Risks or OPRR) are regulations, written by government officials. The NAS uses a "peer" process allowing the scientific community considerable input into animal care and use and self-governance via the Guide. The scientific community, through this process, has been encouraged and enabled to move torward to provide contemporary guidelines for animal care and use.

Prior to the 1985 edition, there was much disparity between the Guide, the AWRs, and the PHS Policy. Prior Guides were more comprehensive, and the recommendations were more extensive and thorough than previous AWRs. However, the AWRs based on the 1985 AWA are similar to the '85 Guide recommendations. The 1986 PHS Policy was expanded and provided more details than previous ones. This interrelationship and congruence of the Guide, the AWRs, and the PHS Policy caused a dilemma for the '96 Guide Committee since any variance from federal regulation and policy would be considered to be noncompliant.

The Committee considered 2 factors in dealing with this issue.

1. We felt obligated to society, science, and animals to update and improve the previous guidelines where possible. The '85 Guide and the AWRs were based on the state-of-the-art practices and science of the early 80s. Ten to 15 years have now elapsed. When the scientific community, represented by the Guide Committee, was aware of new information or ways to improve animal care and use, it was our obligation to address it rather than ignore it. Since the Committee's goal was to write contemporary guidelines, we did not feel limited by outdated information or restricted by existing regulations.

2. The Guide is not intended to be an ancillary set of specifications for the USDA. The Guide has broader and more universal use than just by AWA and OPRR regulated institutions. In the United States, there are perhaps hundreds of users and potential users not covered by the AWRs or funded by the Public Health Service. In addition, the Guide has been used as a reference in other countries.

Engineering versus Performance Standards

In recent years, there has been much discussion about engineering versus performance standards. Engineering standards are prescriptive, design and program oriented, and do not specify goals or outcomes. They do not allow for professional judgment or modification in the event that acceptable alternative methods are available or unusual circumstances arise. They constitute a "one-size-fits-all" approach.

Conversely, performance standards are outcome oriented. Performance standards define outcomes and provide criteria for assessing the outcomes but do not limit the methods by which the outcomes can be achieved. This performance approach is desirable because many variables (such as the species and previous history of the animals, facilities, expertise of personnel, and research goals) often make the engineering approach impractical or unwarranted.

Animal care and use have been moving toward the performance-based approach for years. Examples include assessment of effectiveness of sanitation; assessment of air quality and heating, ventilation, and air-conditioning effectiveness; and veterinary care (e.g., animal health surveillance and surgery). In the past decade, the performance-based concept has gained momentum. There is more emphasis on addressing animal needs, viewing care and use from an animal's perspective, and making biomedical research environments more animal friendly and practical. We are moving from rigid standards and environments made of stainless steel, concrete, and epoxy paint to a softer approach, which allows some flexibility in standards and focuses on enrichments, animal comfort, and behavior-compatible conditions within the limits of the experimental design.

The '96 Guide is a transition Guide. Historically, we think it will be viewed as a "watershed" Guide in the conversion from engineering to performance standards.

Farm Animals

How to deal with farm animals in research and teaching has been an issue for years. The question has evolved around biomedical versus agricultural use. This has led to the development of 2 sets of guidelines, the Guide for the Care and Use of Laboratory Animals (Guide) and the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching (1988) (Ag Guide).

The Guide and the Ag Guide have different objectives. The objective of the Guide for laboratory animals is to assist institutions in caring for and using animals in biomedical or behavioral research, teaching, and testing in ways judged to be scientifically, technically, and humanely appropriate. The Ag Guide evolved as an alternative to the Guide and "is intended to serve agricultural academic institutions and research organizations as a primary reference on the care and use of the major agricultural animal species in the United States in research and teaching that, for reasons of scientific rigor and applicability of results, must be conducted in simulated or actual agricultural production settings. It is meant to serve as an independent reference for the care and use of agricultural animals just as the National Institutes of Health Guide for the Care and Use of Laboratory Animals (NRC 1985) has served users of animals in biomedical research and teaching" (Consortium for Developing a Guide 1988).

It has been suggested that the Guide and Ag Guide be combined. It would be possible to combine the 2 Guides since they have some common goals and features, but there would still need to be different objectives and different recommendations for animals in different settings.

The '96 Guide applies to all animals, including farm animals, used in biomedical research. The '96 Guide's position is that farm animals used in biomedical research can be housed in a conventional laboratory animal setting or on a farm, contingent upon their justified needs and appropriateness for the research. Therefore, the Guide for laboratory animals encompasses traditional laboratory settings and farm settings.

Housing and care for farm animals used in biomedical research might or might not differ from those in agricultural research. Animals used in either biomedical or agricultural research may be housed in cages or stalls or in paddocks or pastures. Some biomedical studies can be conducted in farm settings, and some agricultural studies need uniform laboratory conditions to minimize environmental variability. Decisions on categorizing research uses of farm animals, determining the setting (farm or laboratory), and defining standards for their care and use should be based on user goals, protocols, and concern for animal well-being. Individual situations may differ. Therefore, these decisions should be made locally by the IACUC. Regardless of the category of research, institutions are expected to provide oversight of all research animals and ensure that their pain and distress are minimized.

Information on farm animals is incorporated in all chapters throughout the Guide rather than concentrated in a special farm animal section. There was a diligent effort to make certain that comments applied to farm animals or, if not, to state an exception. Some examples are inclusion of farm animal terms and examples, exclusion of the term "laboratory'' animals and general reference to housing, not caging.

Organization and Overview

The '96 Guide has been partially reorganized and rewritten. It is organized into an introduction and 4 chapters on the major components of an animal care and use program: institutional policies and responsibilities; animal environment, housing, and management; veterinary medical care; and physical plant. Responsibilities of institutional officials, institutional animal care and use committees, investigators, and veterinarians are discussed in each chapter. The introduction has been expanded and includes comments about evaluation criteria, use of farm animals, nontraditional species, and field studies. The definition of laboratory animals has been expanded from warm-blooded vertebrates to include all vertebrates.

The more important changes and additions in Chapters 1 through 4 are briefly described below.

CHAPTER 1: INSTITUTIONAL POLICIES AND RESPONSIBILITIES

Institutional Role

The title of Chapter 1 has been changed to "Institutional Policies and Responsibilities." Institutions, institutional objectives, and institutional personnel vary widely. Unusual or unique needs arise that cannot be foreseen or addressed in a document like the Guide that must have general applicability. The Guide emphasizes the institutional responsibility to ensure that IACUC members are well prepared to evaluate issues brought before them. Accordingly, the revised Guide emphasizes the institution's responsibility to prepare IACUC members by providing "suitable orientation, background materials, access to appropriate resources, and, if necessary, specific training..." Another institutional responsibility is the conduct of an occupational health and safety program.

Institutional Animal Care and Use Committee

The role and responsibilities of IACUCs were updated and expanded to more accurately reflect contemporary views and to approximate the AWRs and PHS Policy. The 2 latter documents differ somewhat regarding IACUC composition, duties, and responsibilities. The '96 Guide is not in strict compliance with either. For example, the '96 Guide states that the public member should not be a laboratory animal user. The importance of IACUC oversight in implementing the Guide is stressed, regardless of the institution's regulatory requirements (such as animal species and funding source).

Much attention is focused on protocol review, and recommendations are made that apply to both preparers (investigators) and reviewers (IACUCs) of protocols. There is a broader range of topics that should be considered in preparation and review of protocols. Special considerations such as physical restraint and multiple major surgical procedures are expanded. Examples of justification of multiple major survival surgery have been expanded to include conservation of scarce animal resources. Guidelines on food and fluid restriction have been added. Not all possible topics are listed, and the list is not meant to be all-inclusive.

An important objective of the Committee when addressing protocols was to make clear that the IACUC has both local authority and responsibility for monitoring and oversight of proper care, use, and humane treatment of animals at its institution. IACUCs and animal care personnel are given discretion in deciding how best to satisfy those duties. Thus, in addition to clarifying institutional and IACUC responsibilities in Chapter 1, the Committee considered it important to reaffirm that IACUCs have discretionary authority to judge and decide how best to meet their obligations in their particular environment. The Guide acknowledges that new information may influence how and why things are done the way they are; IACUCs must be responsibly flexible as our base of knowledge grows.

The IACUC is now charged with establishing a mechanism for receipt and review of concerns involving the care and use of animals at the institution. Previous Guides provided no instruction about this important issue.

Occupational Health and Safety Programs

Consonant with the requirement that occupational health and safety programs (OH&SP) must be part of the overall institutional animal care and use program, this topic has been reorganized and expanded. The roles and responsibilities for various institutional functions and activities in OH&SP are identified.

The OH&SP recommendations reflect the new ILAR document Occupational Health and Safety in the Care of Research Animals (NRC in press). Guidelines are more per-formance-based, focusing on hazard identification, risk assessment, medical evaluation, and preventive medicine for personnel. The reference to substantial animal contact of previous Guides has been omitted. It was recognized that employee participation in the OH&SP should not be based solely on the frequency or duration of animal contact. There is more emphasis on individual case-by-case evaluation of the hazards and the risks posed rather than such broad categorizations.

CHAPTER 2: ANIMAL ENVIRONMENT, HOUSING, AND MANAGEMENT

The scope of Chapter 2 has been broadened beyond that of husbandry alone. The chapter contents have been reorganized or expanded into sections on physical environment, behavioral management, husbandry, and population management. Nevertheless, much of the material from the '85 Guide has been retained. The beginning of the chapter provides more information on the general factors that should be considered when planning to house and care for animals. Goals of maximizing species-specific behaviors and minimizing stress-induced behaviors are emphasized. Environment, housing, and management related decisions are the responsibility of the 1ACUC, the veterinarian, and the investigator. The adequacy of the animals' environment and management should be assessed.

Physical Environment

Discussion of the physical environment begins with definitions of microenvironment and macroenvironment. It is emphasized that the differences in these environments can be significant and implies that measurement of the characteristics of the microenvironment might be necessary in order to assure that the environment is appropriate.

Characteristics of acceptable primary enclosures remain essentially the same except for reference to such things as the behavioral needs of the animals. Materials and design characteristics are presented but state that wood may be acceptable in some circumstances and that rust is of concern only if its presence threatens the health or safety of the animals.

Housing systems such as ventilated caging and isolators are mentioned, and it is emphasized that these systems may require different husbandry practices. It is suggested that consideration be given to flooring systems that provide for the comfort of the animals.

Sections on sheltered or outdoor housing and naturalistic environments have been added. It was recognized that barns, corrals, pastures, and islands may be acceptable in many situations. Benefits, limitations, and specific considerations for these types of housing situations are discussed.

The section on space recommendations with the accompanying tables has not been changed substantially with respect to content. However, the general philosophy has changed. Cage space recommendations are no longer presented as absolute or "minimum." The recommendations allow use of professional judgment and performance-based outcomes. The Guide places responsibility on IACUCs to approve and oversee outcomes of decisions to use space allocations that differ from Guide recommendations. Minimum animal performance criteria for space are provided. These performance specifications must be met regardless of the recommendations listed in the tables. This is especially important for animals that exceed maximum weights listed in the tables.

Pair or group housing is encouraged for social animals. With group housing, less actual space per animal may be needed because of the way each individual uses the total space. For some species such as nonhuman primates, more space may be needed in group situations. In addition, floor area and cage height alone might not completely determine the physical space requirements of the animals.

The space recommendations have been changed from 1 table to 3. Presentation of the weight ranges has been changed somewhat, and emphasis is placed on the probable need for more space for animals that exceed the maximum weights presented in the tables. Metric dimensions for space have been omitted. Dimensions for commercially manufactured caging in the United States and floor areas calculated based on these dimensions are done on even or rounded numbers in inches, feet, square inches, or square feet. Conversions into metric measurements were made in previous editions of the Guide with some loss in precision associated with the conversion factor.

The most noteworthy change in cage size recommendations involves nonhuman primates, which have been divided into monkeys and apes. There are now 7 groups of monkeys. The Committee also recognized that apes have specific needs that were not met by the groupings in the previous Guide. For example, in the '85 Guide space recommended for animals weighing up to 15-20 kg were adequate for young or adult monkeys, but were not sufficient for young apes. Cage heights were also adjusted for the use of vertical space by younger apes. Expansion of the groups for larger monkeys (groups 6 and 7) took into consideration the needs of large macaques and baboons. It was also recognized that larger animals of these species do not require the same vertical space as do apes.

For commonly used farm animals specific recommendations are given for individually housed animals, recognizing that the previous Guide did not address this specifically. Reference to cattle in stanchions was omitted since this is generally a housing method used in production agriculture situations. This type of housing, if used, should be approved by the IACUC and the Ag Guide should be referred to for recommended space. Reference to tie stalls for horses has also been omitted. This type of housing might be considered a form of restraint, necessitating justification, consideration of the experimental protocol, and provision for exercise.

The guidelines on temperature and humidity are essentially the same with 2 exceptions. The recommended temperature range for rabbits has been increased to 72°F, recognizing the difficulty for many institutions in meeting previous guidelines and the ability of the animals to adapt to these slightly higher temperatures. Humidity recommendations have also been changed to a standard 30-70%, a generally acceptable guideline, particularly for animals whose natural habitats are humid.

The guidelines on ventilation have been expanded but still acknowledge that 10-15 air changes per hour is a good general standard. Other criteria and methodologies for determining, more accurately, the ventilation needs of animals under different situations are provided. Newer caging systems, such as those with forced ventilation of the primary enclosure and those with static conditions (filtered tops), are addressed. Criteria and recommendations for recirculating systems are also presented.

Other aspects of the physical environment have changed very little. Additional information and references are provided on the effects of lighting on animals. The Guide acknowledges that the same lighting requirements for albino rodents may not be applicable to nonalbino animals and nonrodent species. References on noise have been updated, and radios and other noise generators are discouraged unless they are part of the protocol or an enrichment program.

Behavioral Management

A Behavioral Management section has been added and includes and expands discussion of activity and social environment and adds a section on structural environment. More emphasis on enrichment and environmental enhancement strategies is included. Group housing is encouraged. The many criteria that must be considered for such housing, especially the compatibility of animals, are discussed. Activity is defined not only in terms of motor activity (exercise) but in terms of cognitive activity and opportunities for social interaction.

Husbandry

In general, topics related to husbandry are essentially unchanged. References have been updated and some areas have been expanded. The guidelines on food include use of irradiated diets as an alternative to autoclaving, use of moderate caloric or protein restriction for clinical and husbandry reasons, and the use of "treats," varied diets, and abrupt changes of diet.

Some additional discussion and information are provided on water treatment. A daily check for water availability is recommended. Accessory water sources in outdoor environments are recognized.

Recommendations for bedding materials were changed very little. It is recognized that certain treatment processes used by manufacturers may reduce the concentration of aromatic hydrocarbons in some types of bedding. Caution is advised when using autoclaved bedding since it may absorb moisture, lose absorbency, and support the growth of microorganisms.

The section on sanitation has been reorganized and expanded. More criteria are provided with which to evaluate performance and outcomes of sanitation processes. Visual inspection is mentioned as a means of assessment. It might be an acceptable sole means of evaluation in situations such as farm animal or other outdoor settings but not in more conventional laboratory animal settings. The frequency and intensity of sanitation may vary in different settings based on numerous factors including the housing systems or experimental protocols. Rigid guidelines on frequency of bedding change are not provided, but achievement of certain outcomes should be assured.

Guidelines on the use of hot water for sanitation are expanded. Specifically, the concept of cumulative heat is introduced. Effective sanitation can be achieved with the appropriate combination of temperature and time of exposure of the surfaces, with actual temperature varying from 143-180°F or more as a function of time.

Sharing of cleaning utensils between rooms is no longer specifically discouraged, recognizing that they may be shared in areas that pose similar risk of contamination. Emptying of bedding in animal rooms is not specifically prohibited.

Sections on waste disposal; pest control; and emergency, weekend, and holiday care have been expanded but contain no major changes. It is suggested that animal care and use programs have a disaster plan.

Population Management

This newly titled section includes information previously provided on identification, records, genetics, and nomenclature. These topics have been expanded to include the use of transponders for identification, computerized record keeping, detail on the suggested content of individual records, and information on transgenic animals.

CHAPTER 3: VETERINARY MEDICAL CARE

Overall, the chapter on veterinary medical care reflects the same underlying principles of the 1985 Guide. However, a number of changes in content or emphasis have been made to address new issues and information.

The components of an effective veterinary medical care program were expanded to include management of protocol-associated disease, disability, or other procedure associated sequelae and assessments of animal well-being. Although these components were not listed as specific components in the '85 Guide, they are not new elements. They are, however, a reminder to attending veterinarians and IACUCs that protocol-associated factors affecting the health and well-being of animals are key components for evaluation, monitoring, and veterinary care.

Animal Procurement and Transportation

This section has been expanded to reflect the importance of providing transport that minimizes stress and injury to animals. The need for adhering to all legal rules and regulations in obtaining animals is emphasized, particularly as it relates to USDA Class B dealers and threatened or endangered species.

Preventive Medicine

Quarantine, Stabilization, and Separation has been expanded and updated. Procedures such as embryo transfer and various means to physically separate incoming animals (such as ventilated racks, isolators, and cubicles) to ensure that pathogens are not introduced into existing colonies are included. The importance of intraspecies separation is stressed when sources differ in pathogen status.

In the section Surveillance, Diagnosis, Treatment, and Control of Disease, the statement regarding daily observation of animals is amplified to reflect that more frequent observations may be needed in such instances as postoperative recovery, illness, or physical deficits. In some instances, however, it may be impractical or unnecessary to observe each animal daily such as when animals are housed in large outdoor settings. The importance of rodent health surveillance programs is emphasized.

Surgery

The Surgery section is expanded to include the importance of presurgical planning, personnel training, aseptic and surgical technique, animal well-being, and the physiologic status of the animal. The importance of continuing and thorough assessment of surgical outcomes is emphasized to ensure that the procedures are appropriate and that timely corrective changes are made. The characteristics of techniques and procedures that are appropriate for rodents and farm animals are explained in greater detail than in the '85 Guide, again, with an emphasis on the importance of outcomes related to animal well-being.

Pain, Analgesia, and Anesthesia

This section has been expanded to emphasize the importance of being able to recognize clinical signs of pain in various species and selecting the appropriate analgesic for specific protocol needs.

Euthanasia

This section has been expanded to include suggested criteria to use in evaluating the means for euthanasia. Protocols should contain criteria for initiating euthanasia that ensures that the end point is humane and the objective of the protocol is achieved. This section also addresses the importance of supervisors understanding that some employees and students can experience psychological difficulties when involved with euthanizing animals.

CHAPTER 4: PHYSICAL PLANT

The Physical Plant chapter of the '96 Guide includes a recommendation that effective planning and design should include input from personnel experienced with animal facility design and operation, and representative users of the proposed facility. Additional narrative is also provided conceming desirable properties of building materials, including the use of nontoxic materials on surfaces with which animals will have direct contact.

Functional Areas

The '96 Guide expands space needs to include areas for care, sanitation, storage, and staff training. Security needs are identified.

Construction Guidelines

Corridors. The '96 Guide states that 6 ft. to 8 ft. corridors will accommodate the needs of most facilities. Rather than specifically referring to coved floor/wall junctions it states they should be designed to facilitate cleaning. It is recommended that fire alarms, fire extinguishers, and telephones be recessed or installed high enough to prevent damage by the movement of large equipment.

Animal room doors and windows. The '96 Guide includes a recommendation for covering viewing windows in situations where exposure to light or hallway activities is undesirable. It is also recommended that doors be designed to be opened from the inside without a key. Exterior windows are not excluded a priori as they may be useful as a form of environmental enrichment for some animals. Exterior windows are usually inappropriate where temperature cannot be regulated properly because of heat gain or loss through the windows, where photoperiod is an important consideration, or if there is a security concern.

Floors and drainage. The importance of proper installation of flooring is emphasized. Textured surfaces are suggested in some high moisture areas and for some species (such as farm animals). The specific recommendation for pitch of floors was discontinued in lieu of a recommendation that floors be sloped for drainage.

Heating, ventilation, and air conditioning (HVAC). In the '96 Guide Temperature and Humidity Control and Ventilation are combined in 1 section.

The '85 Guide included a temperature range of 64.4°F. to 84.2°F. This was deleted and the '96 Guide just refers to controlling temperatures within plus or minus 2°F of the recommendations stated in Chapter 2.

Several new items are included in the '96 Guide. It is recommended that the HVAC system be designed for reliability, ease of maintenance, and energy conservation. The '96 Guide allows temperature and humidity ranges to be modified for acclimated species in sheltered or outdoor facilities. It is noted that brief, frequent, and moderate fluctuations in temperature and humidity are tolerated by most species. Measures to control these fluctuations may include partial redundancy, partial recycling, altered ventilation rates and auxiliary equipment. Total redundancy is seldom practical or necessary. Air filtration and air pressure differential are recommended for certain areas.

Power and lighting. The '96 Guide provides a bit more guidance on the need for an alternative or emergency power supply in the event of power failure.

Noise control. Attention should be paid to attenuating noise and ultrasonic frequencies generated by equipment, environmental monitoring alarm systems, and public address systems.

Facilities for sanitizing materials. Provision for safe bedding disposal and prewashing activities are recommended.

Facilities for Aseptic Surgery

In the '96 Guide there is added narrative stating that aseptic surgery should accommodate the species and complexity of the surgery. There are specific recommendations for rodent and farm animal surgical facilities. The '96 Guide still recognizes 5 functional components of aseptic surgery: surgical support, animal preparation, surgeon's scrub, operating room, and postoperative recovery. The separation of these components is best achieved by physical barriers, but it is acknowledged that this may be achieved by distance between areas or by timing and appropriate cleaning and disinfection between activities. Finally, there is more detail on the control of contamination and what is required in the surgical support and postoperative recovery areas.

Reference to explosive anesthetic agents requiring conductive flooring and explosion-proof outlets 5 ft. above the floor was deleted.

SUMMARY

Since 1963, the Guide for the Care and Use of Laboratory Animals has served as a primary, contemporary guide for animal care and use in the United States. The '96 Guide is the 7th edition. The purpose of the Guide is to assist institutions in developing and maintaining animal care and use programs that are scientifically, technically, and humanely appropriate and to assist investigators in fulfilling their obligation to plan and conduct animal experiments in accord with the highest scientific, humane, and ethical principles. Revision of the Guide was a peer process by an unbiased, objective, balanced, expert committee appointed by the National Academy of Sciences. It has been developed by the scientific community as a part of a self-governance strategy rather than as a regulatory or policy document of the government.

The Guide is written for a diverse group of users, and its guidelines are intended to be applied to many species of animals in varied settings, types of institutions, and uses. The recommendations are based on published data, scientific principles, expert opinion, and experience with methods and practices that have proved to be consistent with high-quality, humane animal care and use. The Guide often makes general recommendations, the details of which must be addressed locally with specific standard operating procedures, decisions by animal care personnel and users, and institutional animal care and use committee (IACUC) approvals.

The '96 Guide has been updated with regard to regulatory compliance, state-of-the-art techniques and equipment, and consideration of new scientific data. It presents a major transition from engineering to performance standards. This approach necessitates a focus on animal well-being and development or definition of appropriate assessment criteria for specific situations. The Guide encourages continued research into improved methods of animal care and use. Also, users, IACUCs, animal care givers, and producers must use professional judgment in making specific decisions regarding animal care and use. The Guide has been partially reorganized to include an introduction and 4 chapters on the major components of an animal care and use program: institutional policies and responsibilities; animal environment, housing, and management; veterinary medical care; and physical plant.

REFERENCES

Consortium for Developing a Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching. 1988. Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching. Champaign IL: Consortium for Developing a Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching.

[NRC] National Research Council. In press. Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC: National Academy Press.

[NRC] National Research Council. 1985. Guide for the Care and Use of Laboratory Animals, 6th ed. NIH Pub. No. 86-23. Washington, DC: US Department of Health and Human Services.

[NRC] National Research Council. 1996. Guide for the Care and Use of Laboratory Animals, 7th ed. Washington, DC: National Academy Press.

[PHS] Public Health Service. 1986. Public Health Service Policy on Humane Care and Use of Laboratory Animals. Washington, DC: US Department of Health and Human Services, 28 pp. [PL 99-158, Health Research Extension Act, 1985].

COMMITTEE TO REVISE THE GUIDE FOR THE CARE AND USE OF LABORATORY ANIMALS

J. Derrell Clark, (Chairman), University of Georgia, College of Veterinary Medicine, Athens, Georgia

Ransom L. Baldwin, University of California, Davis, California

Kathryn A. Bayne, Association for Accreditation and Assessment of Laboratory Animal Care, International, Rockville, Maryland

Marilyn J. Brown, Dartmouth College, Lebanon, New Hampshire

G.F. Gebhart, University of Iowa, College of Medicine, Iowa City, Iowa

Janet C. Gonder, Baxter Healthcare Corporation, Round Lake, Illinois

Judith K. Gwathmey, Harvard Medical School, Boston, Massachusetts

Michale E. Keeling, University of Texas M.D. Anderson Cancer Center, Bastrop, Texas

Dennis F. Kohn, Columbia University, College of Physicians & Surgeons, New York, New York

J. Wesley Robb, Professor Emeritus, University of Southern California, Los Angeles, California

Orville A. Smith, University of Washington, Seattle, Washington

Jo Ann D. Steggerda, Champaign, Illinois

John G. Vandenbergh, North Carolina State University, Raleigh, North Carolina

William J. White, Charles River Laboratories, Wilmington, Massachusetts

Sarah Williams-Blangero, Southwest Foundation for Biomedical Research, San Antonio, Texas

John L. VandeBerg, Southwest Foundation for Biomedical Research, San Antonio, Texas (ex officio member)

Guide for the Care and Use of Laboratory Animals, 7th ed, 1996, National Academy Press, 125 p, ISBN 0-309-05377-3. (Single copies available from ILAR, 2101 Constitution Ave, NW, Washington, DC 20418, Tel: 202-334-2590, Fax: 202-334-1687, e-mail: ilar@nas.edu. To purchase multiple copies ($6.50 for 2-9 copies; $5.95 for 10 or more copies) contact the National Academy Press, 2101 Constitution Ave, NW, Lockbox 285, Washington, DC 20005, Tel: 202-334-3313 or 800-624-6242.)