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. 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. 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. 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. 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. 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. 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 on animal care and use from an and making research more animal and We are moving from standards and of and to a which some in standards and on animal and conditions the of the The ’96 Guide is a Guide . we it will be as a Guide in the from engineering to performance standards. to with farm animals in research and has been an for years. The has versus use. This has to the of 2 of guidelines, the Guide for the Care and Use of Laboratory Animals and the Guide for the Care and Use of Animals in Research and Guide) . The Guide and the Guide have different The objective of the Guide for animals is to assist institutions in caring for and using animals in or and in ways judged to be scientifically, technically, and humanely appropriate. The Guide as an alternative to the Guide and intended to serve institutions and research as a primary reference on the care and use of the animal species in the United in research and for of scientific and applicability of must be in or settings. It is to serve as an independent reference for the care and use of 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 research and ( for a Guide ). It has been that the Guide and Guide be It would be to the 2 Guides since have some goals and but there would still need to be different and different recommendations for animals in different settings. The ’96 Guide to all animals, including farm animals, used in The ’96 is that farm animals used in research can be in a animal or on a their and for the the Guide for animals settings and farm settings. and care for farm animals used in research or not from in Animals used in or research may be in or or in or Some can be in farm settings, and some need conditions to on research uses of farm animals, the or and standards for their care and use be based on and for animal well-being. may decisions be locally by the of the of institutions are to provide of all research animals and that their and are Information on farm animals is in all the Guide rather than in a farm animal There was a effort to make that applied to farm animals to an Some are of farm animal and of the animals and general reference to not The ’96 Guide has been and rewritten. It is into an introduction and 4 on the of an animal care and use institutional and animal and veterinary and of institutional institutional animal care and use and are in each The introduction has been expanded and about use of farm animals, species, and The of animals has been expanded from to include all The more important and in through 4 are The title of Chapter has been changed to and institutional and institutional personnel or that be or addressed in a document the Guide that must have general The Guide the institutional to that IACUC members are to the revised Guide the to IACUC members by to appropriate resources, specific institutional is the conduct of an health and The role and of were updated and expanded to more contemporary and to the AWRs and PHS Policy . The 2 documents IACUC and The ’96 Guide is not in compliance with For example, the ’96 Guide that the public not be a animal The of IACUC in implementing the Guide is of the (such as animal species and Much is focused on and recommendations are that apply to and of There is a broader range of that be considered in and of such as and are Examples of of have been expanded to include of animal Guidelines on and have been all are and the is not to be important objective of the Committee when was to make that the IACUC has and for and of use, and humane of animals its and animal care personnel are given discretion in to in to institutional and IACUC in Chapter the Committee considered it important to that have to and to their in their The Guide that new information may and are the must be as our of The IACUC is now charged with a for and of involving the care and use of animals the Previous Guides provided about this important issue. with the that health and must be of the institutional animal care and use this topic has been and The and for institutional and in are The recommendations the new document Health and in the Care of Research Animals in Guidelines are more on and for The reference to animal of previous Guides has been It was that in the not be based on the or of animal There is more on of the and the rather than such broad The of Chapter 2 has been that of The have been or expanded into on and much of the material from the ’85 Guide has been The of the more information on the general factors that be considered when to and care for of and are and decisions are the of the the and the The of the and be of the with of and It is that the in can be and that of the of the be necessary in to that the is appropriate. of acceptable primary the for reference to such as the of the and design are but that may be acceptable in some circumstances and that is of only its the health or of the such as and are and it is that may different It is that consideration be given to that provide for the of the on or and have been It was that and may be acceptable in many situations. and specific for types of are The on recommendations with the has not been changed with to However, the general philosophy has recommendations are as or The recommendations allow use of professional judgment and performance-based outcomes. The Guide on to and outcomes of decisions to use that from Guide recommendations. animal performance criteria for are performance specifications must be of the recommendations in the This is important for animals that in the or group is encouraged for group animal may be because of the each uses the For some species such as more may be in group situations. In addition, and not completely the of the The recommendations have been changed from to of the has been changed and is on the need for more for animals that the in the for have been for in the United and areas based on are on or in or into were in previous of the Guide with some in with the The change in recommendations which have been into and There are now of The Committee also that have specific that were not by the in the previous Guide . For example, in the ’85 Guide recommended for animals to were for or but were not for were also for the use of by of the for and into consideration the of and It was also that animals of species do not the as do For used farm animals specific recommendations are given for animals, that the previous Guide did not address this to in was since this is a used in situations. This of used, be by the IACUC and the Guide be to for recommended to for has also been This of be considered a of consideration of the and for The guidelines on and are the with 2 The recommended range for has been to the for many institutions in previous guidelines and the of the animals to adapt to recommendations have also been changed to a standard a acceptable for animals are The guidelines on have been expanded but still that air is a good general criteria and for more the of animals under different are such as with of the primary and with conditions are and recommendations for are also aspects of the have changed very information and references are provided on the of on The Guide that the for may not be applicable to animals and on have been and and other are are of the or an has been and and discussion of and and a on More on and is is The many criteria that must be considered for such the of animals, are is not only in of but in of and for In to are have been updated and some areas have been The guidelines on include use of as an alternative to use of or for and and the use of varied and of Some discussion and information are provided on for is in are for were changed very It is that used by may the of in some types of is when using since it may and the of The on has been and More criteria are provided with which to performance and outcomes of is as a of It be an acceptable of in such as farm animal or other settings but not in more animal settings. The and of may in different settings based on factors including the or guidelines on of change are not but of outcomes be Guidelines on the use of for are the concept of is can be with the appropriate of and of of the with from or more as a of of between is that may be in areas that similar of of in animal is not on and and care have been expanded but It is that animal care and use have a This information provided on and have been expanded to include the use of for on the of and information on the on veterinary care the of the 1985 Guide . However, a of in or have been to address new and The of an effective veterinary care program were expanded to include of or other and of animal well-being. were not as specific in the ’85 Guide, are not new They a to and that factors the health and of animals are for and veterinary This has been expanded to the of that and to The need for to all and regulations in animals is as it to and or and has been expanded and such as and to animals (such as and to that are not into existing are The of is when in In the and of the of animals is to that more may be in such as or In some it may be impractical or to each animal such as when animals are in settings. The of health surveillance is The is expanded to include the of personnel and animal and the of the The of and thorough assessment of outcomes is to that the are appropriate and that are The of techniques and that are appropriate for and farm animals are in than in the ’85 Guide, with an on the of outcomes to animal well-being. This has been expanded to emphasize the of to of in species and the appropriate for specific This has been expanded to include criteria to use in the for criteria for that that the is humane and the objective of the is achieved. This also the of understanding that some and can experience when with The of the ’96 Guide a that effective and design include input from personnel with animal facility design and and users of the is also provided desirable of including the use of on with which animals will have The ’96 Guide to include areas for and are The ’96 Guide that to will the of than to it be to It is recommended that and be or to by the of The ’96 Guide a for in where to or is It is also recommended that be to be from the a are not a as may be useful as a of for some are where be regulated because of or through the where is an important or there is a The of of is are in some areas and for some species (such as farm The specific for of was in of a that be for In the ’96 and and are in The ’85 Guide included a range of to This was and the ’96 Guide just to or of the recommendations stated in Chapter new are included in the ’96 Guide . It is recommended that the be for of and The ’96 Guide and to be for species in or It is that and in and are by to may include and is or and air are recommended for The ’96 Guide a more on the need for an alternative or in the event of be to and by equipment, and public address for and are In the ’96 Guide there is that the species and of the There are specific recommendations for and farm animal The ’96 Guide still of animal operating and The of is by but it is that this may be by between areas or by and appropriate and between there is more on the of and is in the and to and the was Since the Guide for the Care and Use of Laboratory Animals has served as a contemporary for animal care and use in the United The ’96 Guide is the The purpose of the Guide is to assist institutions in developing and animal care and use 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. of the Guide was a process by an unbiased, objective, balanced, expert committee appointed by the National Academy of It has been by the scientific community as a of a self-governance rather than as a or policy document of the 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 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 to state-of-the-art techniques and equipment, and consideration of new scientific data. It a from engineering to performance standards. This approach a on animal and or of appropriate assessment criteria for specific situations. The Guide research into methods of animal care and use. users, animal care and must use professional judgment in making specific decisions animal care and use. The Guide has been to include an introduction and 4 on the of an animal care and use institutional and animal and veterinary and
Agriculture• 1997• Oxford University Press