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ASSESSMENT OF ANIMAL HOUSING NEEDS IN THE RESEARCH SETTING 87 should be paid to the guidelines for accommodation and care of animals set out in Appendix A to this Convention. . . . Cages and pens should be designed for the well-being of the species and should permit the satisfaction of certain ethological needs (for example the need to climb, hide or shelter temporarily). . . (CoE 1986, Appendix A, paragraph 3.6.3). However, on the species-specific level, the guidelines are restricted to...

Established Space Requirements

The minimum space requirements of the European Convention (CoE 1986) are based on a mathematical calculation model with arbitrarily set constant factors, slope, and starting point. The slopes represent weight-bands and allow the space requirements for a given number of rabbits to be calculated. The heavier the rabbits, the fewer square centimers of space are required per weight unit. The calculation model refers only to body weight and does not make a distinction between strains, sex, and age....

Introduction

Laboratory animals such as rabbits are bred and housed for experimental use. The living conditions, housing, and husbandry are often more obstructive and more stressful for the animals than the experimental procedure itself. Therefore, the potential negative effects of an experiment on a laboratory animal's well-being are not restricted to the experiment itself but instead cover the whole life span of the animal. Discussions of welfare requirements and their practical implementation could be...

Rabbit Behavior And Need For Space

Rabbits do not use space per se they use resources and structures within an area for specific behaviors. Appropriate structuring of the cage pen environment may be more beneficial than provision of a larger floor area however, a minimum floor area is needed to provide a structured ASSESSMENT OF ANIMAL HOUSING NEEDS IN THE RESEARCH SETTING 89 space (e.g., blinds, shelters, and platforms) that includes withdrawal areas and vantage points. Rabbits tend to be highly motivated, to make use of...

References

Bayne, K.A., Dexter, S.L., Hurst, J.K., Strange, G.M., Hill, E.E. 1993. Kong toys for laboratory primates Are they really an enrichment or just fomites Lab Anim Sci 43 78-85. Bayne, K., Mainzer, H., Dexter, S., Campbell, G., Yamada, F., Suomi, S.J. 1991. The reduction of abnormal behaviors in individually housed rhesus monkeys (Macaca mulatta) with a foraging grooming board. Am J Primatol 23 23-35. Berard, J.D. 1989. Life histories of male Cayo Santiago macaques. Puerto Rico Health Sci J 8...

Recommendations And Anticipated Revisions

In the proposal for the revision of Appendix A of the European Convention ETS 123, the Expert Group on Rodents and Rabbits recommends that medium-sized (< 4 kg) rabbits such as New Zealand White rabbits should be housed in cages with a floor area of 4200 cm2 and a height of 90 SCIENCE-BASED GUIDELINES FOR LABORATORY ANIMAL CARE 45 cm, including a raised area of approximately 55 x 30 cm where one rabbit or two compatible rabbits can be housed. Without a raised area, floor space should be 5600...

Other Acts And Executive Orders

Although the APA sets forth the basic requirements for federal rulemaking, other acts and executive orders also apply and include the following (1) Executive Order 12866, which provides for review of federal rules by the Office of Management and Budget (OMB) (part of the Office of the President) and which requires the preparation of cost-benefit analyses for some rules and (2) the Regulatory Flexibility Act, which requires analyses by agencies of the potential economic effects of their rules on...

Environmental Enrichment

There are many different methods to enrich the environment of captive primates, ranging from the provision of objects, foraging devices, or videotapes to the redesign of the cage environment (see various commercial cage vendors). As with social housing, the emerging picture suggests that there are both costs and benefits. The most obvious benefit is that environmental enrichment promotes species-typical behavior in the form of exploration. Thus, most monkeys spend some time using foraging...

The Development Of

SCIENCE-BASED GUIDELINES FOR LABORATORY ANIMAL CARE Proceedings of the November 2003 International Workshop Institute for Laboratory Animal Research Division on Earth and Life Studies THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National...

International Workshop On The Development Of Sciencebased Guidelines For Laboratory Animal Care Program Committee

Klein, VMD (Chair), Merck Research Laboratories, West Point, Pennsylvania Stephen W. Barthold, DVM, PhD, University of California, Davis Coenraad F.M. Hendriksen, DVM, PhD, Netherlands Vaccine Institute, Bilthoven, Netherlands William Morton, VMD, National Primate Research Center, University of Washington, Seattle, Washington Randall J. Nelson, PhD, University of Tennessee Health Science Center, Memphis, Tennessee Emilie F. Rissman, PhD, University of Virginia Medical School,...

Social Housing

Scientific evidence suggests that there are a number of potential benefits to social housing, the most obvious of which is the ability to groom and affiliate with other monkeys. Companions may also serve as a buffer 82 SCIENCE-BASED GUIDELINES FOR LABORATORY ANIMAL CARE to stressful events (Winslow and others 2003). Other potential benefits of companionship include increased disease resistance (Shively and others 1989) and improved immune response (Lilly and others 1999 Schapiro and others...

Proposed Rule

Most rulemaking in APHIS begins with a proposed rule. This document must contain a preamble that includes the following, at a minimum an explanation of the proposed rule an analysis of the anticipated economic effects of the proposed rule a description of any information collection requirements an invitation to the public to submit comments by a CURRENT STATUS IDENTIFYING THE ISSUES 43 specified date (usually 60 days after publication) and the proposed rule itself, as it would appear in the...

The Council Of Europe How Does It Work

The headquarters of the Council of Europe, Le Palais de l'Europe, is situated in Strasbourg, France. The Committee of Ministers is the decision-making body of the Council of Europe. It is composed of the Ministers of Foreign Affairs of the member states. This body officially adopts Conventions, Resolutions, Agreements, and Recommendations. The Committee of Ministers also ensures that the conventions and agreements are implemented. In addition, there are two other institutions (1) The...

Wim deLeeuw

Shortly after the end of World War II, several movements and activities were born that were dedicated to European unification. As an overall result, the Council of Europe was founded as an international political institution in 1949. It is designed only with international cooperation in mind. The general aims of the Council of Europe are to Protect human rights, democracy, and the rule of law in all member states Promote awareness and encourage Europe's cultural identity and diversity Seek...

William J White

The 1996 Guide for the Care and Use of Laboratory Animals (Guide) is the most recent version of seven editions of the document beginning with the 1963 edition. The 1963 Guide was developed by a committee of seven members and consisted of 33 pages divided into three sections, whereas the 1996 Guide was developed by a committee of 16 members and spanned 125 pages divided into five sections. The charge to the 1996 Guide committee was to develop a guidance document for laboratory animal care and...

The Council Of Europe And Animal Welfare

The work of the Council of Europe on animal protection was started in the 1960s. Since then, the following five Conventions on the protection of animals have been drawn up (1) On animals during international transport (ETS 65, 1968), which establishes general conditions for the international transport of animals (2) On animals kept for farming purposes (ETS 87, 1976), which is a framework convention. More detailed recommendations on species are given in separate guidelines (3) On animals for...

Direct Final Rule

The direct final rule is a type of rule that provides a shortcut for noncontroversial rules that are unlikely to generate even one negative comment. The direct final rule must include the following, at a minimum an explanation of the rule an analysis of anticipated economic effects of the rule a deadline for submitting comments a tentative effective date and the rule itself, as it would appear in the Code of Federal Regulations. If no adverse comments are received by the close of the comment...

Acknowledgments

Support was provided during the preparation of this paper from grants to F.vS. from the National Institute of Environmental Health Sciences (NIEHS) (ES11283), C.A.R. from NIEHS (ES-11549), S.C.N. from the National Institute of Diabetes and Digestive and Kidney Diseases (DK60567), and W.V.W. from the National Cancer Institute (CA50354) and the University of Missouri (VMFC0018). ASSESSMENT OF ANIMAL HOUSING NEEDS IN THE RESEARCH SETTING 69 Boettger-Tong, H., Murthy, L., Chiappetta, C., Kirkland,...

Europe

The year 1986 was important in terms of the following (1) the Council of Europe concluded the convention for the protection of vertebrate animals used for experimental and other scientific purposes (2) the European Union formulated directives on the approximation of laws, regulations, and administrative provisions to rectify disparities in welfare policies among member states and (3) in the United Kingdom, the Cruelty to Animals Act of 1876 was amended and its title changed to the Animals...

Administrative Procedure

The Administrative Procedure Act (APA) contains the basic requirements for federal rulemaking. For most rulemaking, the APA requires the following Publication in the Federal Register of a proposed rule, including either the terms or substance of the proposed rule Opportunity for public participation in rulemaking through submission of written comments on the proposed rule Publication in the Federal Register of a final rule, with an explana- 42 SCIENCE-BASED GUIDELINES FOR LABORATORY ANIMAL CARE...

John G Miller

The Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International is a not-for-profit corporation established in 1965 as the American Association for Accreditation of Laboratory Animal Care. From its inception, AAALAC has had sound science as a principal focus. A 1964 report of AAALAC's predecessor, the Animal Care Panel, included the following statements As part of the scientific community, the Animal Care Panel has been working to define the conditions of...

In 1997 the CoE adopted a resolution on accommodation and care of

Vertebrate animals used for experimental and other scientific purposes (Council of Europe 1997). It had been generally agreed by the CoE that the existing Guidelines for accommodation and care of animals presented in Appendix A of Convention ETS 123 had proved very useful and had been applied widely within Europe. However, it was also acknowledged that scientific knowledge and experience had progressed since 1986 and ASSESSMENT OF ANIMAL HOUSING NEEDS IN THE RESEARCH SETTING 71 the entry into...

Laboratory Findings

Both social housing and environmental enrichment are considered important regulatory requirements for promoting psychological well-being in captive primates. The logic of this view for rhesus monkeys is derived in part from their life history. However, there are also laboratory studies in which the effectiveness of social housing and environmental enrichment have been examined, and the emerging picture from this work suggests that there are both benefits and costs, depending on the research...

A need is identified

A regulatory work plan is prepared, cleared within the Department of Agriculture, and designated as significant or not significant by OMB. A writer on the regulatory staff of APHIS receives the assignment and works with a technical expert from the relevant APHIS program area and others to develop the rule. The proposed rule is drafted and cleared within APHIS. The Office of General Counsel (OGC) of USDA reviews and clears the rule for legal sufficiency, and policy officials within the...

Staff

Joanne Zurlo, PhD, Director, Institute for Laboratory Animal Research Marsha Barrett, Senior Project Assistant Kathleen Beil, Administrative Assistant INSTITUTE FOR LABORATORY ANIMAL RESEARCH COUNCIL Peter A. Ward (Chair), Department of Pathology, University of Michigan Medical School, Ann Arbor, Michigan Stephen W. Barthold, Center for Comparative Medicine, University of California, Davis, California William C. Campbell, Drew University, Madison, New Jersey Rosemary W. Elliott, Department of...

Committee For Revision Of The Guide

The writing of the 1996 Guide spanned five committee meetings and involved seven major drafts with numerous minor drafts developed over a 2-year period. The major sections of the Guide were selected based on the principal components of an animal care and use program. Subcommittees of the parent committee prepared drafts of sections for full committee review and discussion. Literature searches were provided by the National Agricultural Library. The final document underwent two rounds of external...

Need For Additional Scientific Data

Clearly, much more information needs to be generated before any changes are made in guidance. Complex interactions need to be more clearly understood and considered across a wide range of applications of these guidance documents. It is unlikely that a very defined amount of critical space can be shown to be an absolute requirement, and it is unlikely that relationships are going to be linear. Key information is not available on topics as simple as occupied floor area versus body weight. It is...

History

Through an initiative of the United Nations Educational, Scientific, and Cultural Organizations (UNESCO), the Council for International Organizations of Medical Sciences (CIOMS), and the International Union of Biological Sciences (IUBS), the International Committee on Laboratory Animals (ICLA) was conceived in 1956 as a nongovernmental organization to promote high standards of laboratory animal quality, care, and health. Its activities have included collaboration with the World Health...

Time Frames

The time required for a given rulemaking varies, depending on the complexity of rule, the number and nature of comments received, the priority assigned by the agency (APHIS has an average of 150-200 actions in progress at any given time), and the designation assigned by OMB. Rules designated significant take longer than rules designated not significant, at least partly because the clearance process within the department involves more policy officials and because OMB also reviews the document....

Current Status Of The Revision

Initially, only four Expert Groups had been established, on (1) Rodents and Rabbits, (2) Dogs and Cats, (3) Nonhuman Primates, and (4) Pigs and Minipigs. These four groups were given the task of preparing Species-Specific proposals, with the General Part of the new proposals, including provisions common to all species covered, being drafted with input from all four groups. The Working Party later decided to add additional species covered by the Convention to the list of those already to be...

Speciestypical Behavior

The key to developing effective strategies for housing rhesus monkeys in captivity is to understand their behavior in nature. From a social perspective, rhesus monkeys live in relatively large troops ( 20-30 individuals on average) that consist of both sexes and all age classes (Lindburg 1971). These troops operate as closed societies and repel strangers with acts of aggression (Southwick and others 1965, 1974). Females spend their lives in their natal troop preferentially interacting with...

Preface

Each country or group of countries addresses the regulation of laboratory animal care in its own way, and even within a single country, there may be different agencies exerting separate regulations or guidelines (e.g., the US has regulations through the Animal Welfare Act administered through the Department of Agriculture and through the Health Extension Act administered through the Department of Health and Human Services as Public Health Service Policy). In Europe, the member nations of the...

Law Concerning Protection Control of Animals

Standards Re. the Care & Management of Lab Animals Protocols approved by Home Office (ERP) Protocols approved by IACUC (mandatory) USDA inspection Protocols approved by IACUC (voluntary) No legal inspection FIGURE 1 Comparison between regulations on animal experiments in the United Kingdom, the United States, and Japan. USDA, US Department of Agriculture IRAC, Interagency Research Animal Committee DHHS, Department of Health and Human Services AWA, Animal Welfare Act PHS, Public Health...

Cage Space

Cage space is another environmental parameter for which there are very few specific data. Providing an adequate amount of cage space is generally thought to be important for animal well-being. Unfortunately, guidelines have been established based on consensus, surveys, some data, and appearance to observers. Although it is intuitive that relationships must exist between cage space and parameters thought to indicate overcrowding, these relationships have never been studied well and are prone to...

Spatial

Cage size Participants did not discuss this topic, but instead reached consensus that cage size should be sufficient to accom- ENVIRONMENTAL ENRICHMENT ISSUES 197 modate all agreed-upon enrichments and to permit normal postural adjustment. Animals prefer to observe from above, but there is not necessarily a physiological difference to accompany this. Periodic access to larger activity cage (frequency, duration) Tactile social contact with conspecifics Degrees and type of conspecific contact...

Harmonization And Diversity

Within Europe, there might be one Directive and one Convention to protect animals used for scientific purposes but even within the EU, there are nevertheless 15 ways of doing it. Within the EU, the various national systems give a first impression of diversity, rather than harmony. Nevertheless, although the details vary, they have many elements in common and much of the meeting presentation will compare and contrast key elements of several national systems. Their commonalities include...

Contents

Building the Case for Science-based Guidelines Introductory PLENARY Genes, Environments, and Mouse SESSION 1 CURRENT STATUS IDENTIFYING THE ISSUES 15 AAALAC International The Council of Europe What Is ICLAS and the International Role of the National Institutes of Health Office of Laboratory Animal Welfare and the Public Health Service Policy on Humane Care and Use of Laboratory Nelson L. Garnett Regulatory Authority of the US Department of Agriculture Animal and Plant Health Inspection A Review...

Chester A Gipson

Congress passes, and the President signs, all legislation authorizing activities of the Animal and Plant Health Inspection Service (APHIS) of the US Department of Agriculture (USDA). The laws authorize or direct the Secretary of Agriculture to take certain actions, which may include issuing regulations. The Secretary delegates authority to the Under Secretary of Marketing and Regulatory Programs (MRP), who then delegates authority to the Administrator of APHIS. The Administrator of APHIS...

Frederick S vom Saal Catherine A Richter Rachel R Ruhlen Susan C Nagel and Wade V Welshons

Mammalian embryonic development is epigenetic in that hormonal signals not only control the timing of gene expression but also set the activity of genes and thus the functioning of organs and homeostatic systems for the remainder of life. Variation in endogenous hormones (e.g., estradiol and testosterone), which regulate the development of organs (vom Saal 1989), or disruption of the activity of these hormones during development by chemicals can lead to permanent changes in organ structure and...

Leader Harry J M Blom Rapporteur Michael K Stoskopf

The session leader posed the following questions to the group What is the scientific basis or peer-reviewed literature for housing standards for laboratory animals What other (if any) influences or factors are involved General consensus was quickly reached among the participants that the scientific basis for housing standards for laboratory animals is uneven, with large areas that lack adequate investigation. Some concern was expressed that not all scientific information is sufficient for...

Bernard Blazewicz and Dan Frasier

Current guidance regarding environmental conditions for vivariums is primarily found in industry and government publications. The most widely accepted publication and the primary reference on animal care and use is the Guide for the Care and Use of Laboratory Animals (the Guide), published by the National Research Council (NRC 1996). Other pertinent references include the American Society of Heating, Refrigeration, and Air-Conditioning Engineers (ASHRAE 2003), the National Institutes of Health...

Communicating The Performancebased Approach

The performance-based approach specifies the desired outcome and provides criteria for assessing the outcome, but it does not specify how to achieve the outcome. In constructing the Guide, it was appropriate in some instances to provide examples, but to emphasize clearly that multiple methods could be acceptable and the choice of method had to be adjusted, based on circumstances. Given the lack of data on which to base detailed guidance in many aspects of animal care and use, the...

Melinda Novak

Nonhuman primates are a crucial research resource because they serve as important models for understanding human health and well-being. However, their success as models depends on balancing two important needs the research objectives and the well-being of the animals. The balance is not always easy to achieve because we do not fully understand how to maintain primate well-being in a laboratory setting. This discussion reviews information relevant to the housing of rhesus macaques, one of the...

Summary

For most requirements that the agency imposes on the public, the APA requires APHIS to conduct rulemaking. Although APA contains the basic requirements for rulemaking, including publication in the Federal Register, other laws and executive orders also apply to rulemaking. Among the various types of rulemaking documents, the most typical is a proposed rule followed by a final rule. Regulations are reviewed within APHIS, by the Office of General Counsel (USDA) and other policy officials, and, if...

Mission And Aims

ICLAS advances human and animal health by promoting the ethical care and use of animals in research worldwide. The aims of ICLAS are To promote and coordinate the development of laboratory animal science throughout the world and as a matter of priority in developing countries To promote international collaboration in laboratory animal science To promote quality definition and monitoring of laboratory animals To collect and disseminate information on laboratory animal science To promote...

Derek Forbes

Papers presented by earlier speakers have emphasized that the Guidelines for accommodation and care of animals presented in Appendix A of the Convention have proven to be very useful and have been widely applied. However, since 1976 when the Convention was first applied, scientific knowledge and experience have advanced considerably. Moreover, there has been an increased public interest in and awareness of animal usage in experimentation and a regard for their welfare. The author as a...

Membership Of Expert Group On Dogs And Cats And Modus Operandi

As with all of the Expert Groups, there was a broad-based representation drawn from the observer nongovernmental organizations of the CoE. The membership of the Expert Group on Dogs and Cats comprised one representative from each of the following the Eurogroup for Animal Welfare, the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Federation of Laboratory Animal Breeders Associations (FELABA), the Federation of Veterinarians in Europe (FVE), and the International...

Leader Vera Baumans Rapporteur Jennifer Obernier

Guidelines for this breakout session encouraged its leader and participants to debate current research on rabbit housing standards and guidelines in light of current scientific information. In particular, the participants discussed the pros and cons of group housing, the standards and guidelines that govern minimum caging size, and the climate of the housing environment. Both the Council of Europe (CoE 1986) and the Guide for the Care and Use of Laboratory Animals (the Guide) (NRC 1996)...

Costs

Time cost implementation, sanitization, etc. Risk injury, disease transmission biosafety concerns for personnel ENVIRONMENTAL ENRICHMENT ISSUES 195 Rebound effect increased cost if enrichment conditions are changed social and physical Research protocol constraints Good laboratory practice toxicology Testing sampling (leaving home cage, perhaps) Infectious disease Species, gender, age considerations, variability Individual differences exist and are noticeable in NHPs Extent to which maladaptive...

Conclusions

Understanding complex traits can be advanced through studies with mouse genetic models. However, modeling genetic effects cannot rely on simplistic assumptions about the environment. Although any careful experimenter standardizes conditions within his or her own laboratory to achieve reliable genetic results, it cannot be assumed that within-laboratory reliability translates directly into across-laboratory reliability. Some features of the laboratory environment are nearly impossible to...

Impact Of Recommendations

The committee was also concerned about the impact of recommendations on the conduct of research or testing including a potentially increased risk of microbiological contamination. Implementation of recommendations that might contribute to microbiological contamination could invalidate many types of research and thus result in greater animal usage. The guidance provided in the Guide had to be achievable, such that the intended benefit would be proportional to the resources required. The...

Conclusion

In the context of the ILAR International Workshop on Development of Science-based Guidelines for Laboratory Animal Care, ICLAS can play an important role because of 1. Its role as an international umbrella organization a. ICLAS membership includes countries from every region of the world and b. The impact of ICLAS programs to ensure diffusion of good science and good animal welfare practices is felt worldwide, through ICLAS Meetings, Regional Programs, the Communication Program, and other ICLAS...

What Is An Animal Welfare Assurance

The Assurance is a written document that provides the basis for a trust relationship between the institution and the government. It describes your unique program of animal care and use and, once approved, becomes a criterion for future evaluation. An approved Assurance is required for eligibility to receive PHS support. The Assurance describes, in some detail, the program of animal care and use and must address all of the following elements of that program applicability, lines of authority and...

Legal Systems In Japan

The detailed legal system in Japan is described in Figure 2 from an historical viewpoint. The Law Concerning the Protection and Control of Animals enacted in 1973 was amended in 1999 and given the new title of the Law for the Humane Treatment and Management of Animals. This law protects all species of animals from cruelty (Investigative Committee 2001). The law emphasizes respect for life, companionship with animals, and well-being of animals. It specifies the responsibility of the owner of the...

Leader Sherri L Motzel Rapporteur Hilton J Klein

0.8-100 kHz 0.25-76 kHz 0.13-45 kHz 0.04-46 kHz 154 SCIENCE-BASED GUIDELINES FOR LABORATORY ANIMAL CARE Thus, animals detect sound inaudible to humans. The US Animal Welfare Act regulations do not address noise. However, the ILAR Guide for the Care and Use of Laboratory Animals (NRC 1996) includes the recommendation to assess the effects of noise on animals, and to consider noise controls in animal facility design and construction. The Agricultural Guide (APHIS 1998) reflects greater tolerance...

Kay E Holekamp

My goal in this presentation is to review briefly a few seminal contributions from classical ethology and contemporary behavioral ecology that might help us develop better guidelines for use and care of laboratory animals. All of these contributions emphasize the importance of understanding the lives of animals in nature as we try to improve laboratory guidelines. I shall illustrate some of my points here with examples drawn from the lives of my own study animal, the spotted hyena (Crocuta...

European Union Directive 86609eec 1986

The statutory instrument EU Directive 86 609 EEC makes provision for the harmonization of laws for the protection of animals produced and used for experimental and other scientific purposes. In scope, it covers safety testing work aimed at preventing, detecting, and controlling disease the assessment, detection, and modification of physiological functions and protection of humans and the natural environment. However, unlike the Convention, it probably does not cover fundamental research...

Hilton J Klein

On behalf of the National Academy of Sciences, the National Research Council, and the Institute for Laboratory Animal Research (ILAR), I would like to extend my appreciation to the speakers and all of the attendees for participating in our meeting over the next several days. I especially thank ILAR Council Chairman Dr. Peter Ward, the members of the ILAR Council, and the members of the ILAR Council's International Committee (Drs. Barthold, Hendriksen, Morton, Nelson, Rissman, and Stokes) for...

Bedding

Recent studies have shown that bedding types that allow burrowing or nesting allow operating ambient temperatures to be increased from an ambient of 22 C to an effective ambient of 29 C. By contrast, bedding that allowed only resting on its surface, but not burrowing, increased temperatures by 2 to 4 C depending on the bedding type. These findings beg the question of whether rodents are using bedding for thermal regulation rather than for psychological enrichment, as suggested in some guidance...

Paul Gilman

The research and development arm of the US Environmental Protection Agency (EPA) employs 1,950 employees at 13 laboratories and research facilities across the nation. Its 700 million budget for fiscal year 2003 included a 100 million extramural research grant program. The focus of those people, facilities, and programs is the generation of credible, relevant, and timely research results and technical support that inform EPA's policies, decision making, and promulgation of regulations. Setting...

Timo Nevalainen

Recently a Council of Europe (CoE) expert group emphasized the need for environmental enrichment and group housing as refinements for all laboratory species unless there are scientific or veterinary reasons not to do so (Hansen and others 1999). This emphasis is part of the revision of CoE Appendix A, in which species-specific recommendations serve as a starting point in the choice of enrichment. Indeed, the questions are not whether to use but how to use enrichment, and how far it should be...

Jonathan Richmond

The regulation of the use of animals for experimental and other scientific purposes and the determination of minimum required standards of animal care and accommodation across Europe are issues and processes noted more for their complexity and opaqueness than uniformity and transparency. Although each European member state devises and implements its own national legislation and standards of care and accommodation, these domestic provisions are informed, and in some cases determined, by...

Leaders Bernard Blazewicz and Dan Frazier Rapporteur Janet Gonder

Participants began by listing a series of issues for possible discussion. Topics included biosafety and biosecurity ventilation rates and effectiveness of ventilation ventilated caging systems relative humidity control sources of humidification monitoring need for filtration and sources of contaminants. Several of these issues were discussed. Discussion of the engineering issues related to biohazard research centered around biosafety level (BSL) 3 and BSL4 housing for agricultural animals and...

Leader David Whittaker Rapporteur Randall J Nelson

Participants discussed the questions that appear below, in general consideration of the guideline revision process Who, How, and Outcomes How should the next revision of the Guide for the Care and Use of Laboratory Animals (the Guide) (NRC 1996) be conducted Participants believed that expert groups chosen to address specific issues should conduct the revision of the Guide. Is the lack of scientific knowledge in an area sufficient reason not to move forward with revision Session Leader David...

Where are the gaps in our scientific knowledge

Participants outlined the following benefits of performance standards for assessing environmental enrichment in NHPs Promote normal behavior Stimulate a range of normal behaviors, thereby preventing or reducing the development of abnormal behaviors. Reduce abnormal behavior Redirect activities from abnormal to normal provide outlets for behaviors that might otherwise be self-directed and possibly injurious. Reduce stress and associated physiological imbalances Increase the ability of the animal...

The Baby And The Bath Water

Does this mean that behavioral genetics is doomed Are behavioral responses simply too variable, as we often hear from our molecularly inclined colleagues Is the answer removing the experimenter from the experiment through automation We tend to disagree with these gloomy thoughts. Rather, we think that the stability of genetic influences is often overlooked. Genotype was the strongest effect for all behaviors in the multisite trial. As Doug Wahlsten and I have continued our work exploring GXE...

Basis For Dog And Cat Recommendations

The CoE stipulated the provision of proposals for a General Section and for Species-Specific Sections (called Part A). It also requested a supporting explanatory and referenced text (Part B) for each of the sections. Groups were directed to pay special attention to enrichment of the environment, particularly in relation to social interactions, activity-related use of the space, and provision of appropriate stimuli and materials. Proposals were to be based on science-based information when it...

Current Status

Current regulations regarding animal experimentation in Japan are summarized in Table 1. The three categories include the following laws consisting of the law, the standards, and the guide administrative guidance issued by the Head of Science and International Affairs Bureau through their bulletin, which includes the notification and voluntary guidelines formulated by individual scientific associations. Laboratory animal scientists in Japan have observed all three categories of regulations...

Practical Issues In The Development Of Guidance For Housing Standards

One of the most difficult sections to construct in the Guide was the animal environment section, which included housing needs of laboratory animals. Although it was intuitive that the housing environment of laboratory animals somehow affects their performance and well-being, there was not a great deal of information available to provide very specific recommendations. In most cases, only unrelated proof of principle studies that demonstrated housing environmental effects on animals or research...

Specific Proposals Relating to Cats

The proposals on housing and enrichment and on dimensions and flooring for cats took account of consideration similar to those for dogs (Table 3). It was recognized that cats have a strong tendency to learn social behavior, even though they are descended from a solitary species. They do not, for example, form distinct dominance hierarchies. However, it was also recognized that the process of forming social relationships may be stressful and that interpreting visible signs of stress may be more...

Sources Of Individual Differences

The sources of environmental influence that led to strain-specific responses in the multisite trial could not be identified. However, a more recent experiment offers some plausible suggestions. During the early course of his several-year career ranging from postdoctoral fellow to associate professor, Jeff Mogil and his assistants had collected baseline data on a simple, spinally mediated reflex response to acute pain in mice, the tail withdrawal reflex (Chesler and others 2002a,b). Each mouse...

Leader Robert Hubrecht Rapporteur Thomas Wolfle

The session began with a review of dog cage or pen size guidelines, policies, and regulations in the United Kingdom and the Council of Europe (CoE 2001), in Canada (according to pertinent documents of the Canadian Council on Animal Care CCAC www ccac.ca ), and in the United States (according to the Guide for the Care and Use of Laboratory Animals NRC 1996 ). Video examples were shown of stereotypies in dogs (e.g., cage chewing) and remediation with cage enrichment. A timebudget chart was...

Leaders Jann Hau and Randall J Nelson Rapporteur Stephen W Barthold

The introductory discussion focused on the impact of new guidelines on immune response and metabolism. Significant changes that may influence these responses include social grouping, environmental enrichment, and enclosure size. 1. Is there consistent scientific evidence for an impact of social environment (or environmental enrichment) on the immune system and metabolism If so, is the evidence species specific 2. Is there a need for additional research on the impact of social environment or...

Leader Graham Moore Rapporteur Janet Gonder

The participants began by identifying discussion topics. Topics included enrichment beyond exercise clarification of the use of structures (do they add or subtract from floor space ) recommendations on socialization acquisition of animals (e.g., experience and socialization at the vendor) vertical space for dogs exercise (what, when, how, why) and Council of Europe requirements. Most of the discussion was directed at dogs, but specific issues for cats were noted. The term enrichment was...

Comments From Audience

Several members of the audience were rather skeptical about several aspects of enrichment. It was suggested that many enrichment items, such as houses and tubes, can be used without increasing the space. Because these objects also can provide extra space for exploration of the mice or rats, they themselves increased the useable space. The assumption that enrichment increases an animal's well-being was questioned. It was suggested by participants that scientific data should be sought in order to...

The Challenge

As we seek to define scientifically based regulations and guidelines, we should define the word science. Science is derived from the Latin scientia or knowledge. It is defined in the dictionary as the systematic observation of natural phenomena for the purpose of discovering laws governing those phenomena. It is somewhat ironic, therefore, that we are using this workshop to define regulations and laws regarding animal use in research based on science. We should examine how regulations, laws,...

Clment Gauthier

The Canadian Council on Animal Care (CCAC) is the national organization that has set and overseen the implementation of standards for the care and use of animals in science since 1968. It is a peer review organization involving close to 2000 scientists, veterinarians, animal care technicians, students, community representatives, and representatives of the animal welfare movement through its programs of assessment, guidelines development, education, and training. The CCAC pioneered the...

Multisite Trial

Several years ago, my colleagues Doug Wahlsten at the University of Alberta in Edmonton, Bruce Dudek at the State University of New York at Albany, and I set out to evaluate the stability of strain differences in some simple laboratory behaviors. Our principal interest was whether the reliability of the genetic differences on a behavior we saw routinely within each of our laboratories was predictive of reliability of genetic differences across laboratories. After numerous phone calls, meetings,...

Religious Implications

A Thai venerable who graduated from medical school made a presentation about the philosophy of Karma in Buddhism at the 2003 annual CURRENT STATUS IDENTIFYING THE ISSUES 55 meeting of the American Association of Laboratory Animal Sciences. Researchers in Buddhist countries regard animals as existing on the same level as humans and generally treat animals based on the philosophy of Karma. Buddha rewards or punishes people based on their deeds (Karma). The logic of reincarnation is called...

Eight Week Study C57BL6J Mice House in Three Cage Types

All 1080 B6 mice that began the study survived, and we did not observe any aggressive behavior or injured mice. The mean weights of mice at the termination of this experiment were ( standard error SE ) 20.4 0.6 g and 29.8 0.8 g for females and males, respectively. The incidence of alopecia among B6 female mice used in this study was relatively low, varying from 0 to 6 per treatment group, and was unrelated to cage type or housing density. Microenvironment in Cages Housing C57BL...

Four Week Study C57BL6J Mice Housed at Higher Densities

Because we observed no deleterious effects of housing 20 C57BL 6J mice in 112.9 in2 weaning cages for 8 weeks with 5.6 in2 per mouse, we followed up with a 4-week study that evaluated the same parameters for mice provided with even less floor space 3.2 in2 per mouse. We monitored the microenvironments of both male and female mice twice weekly in this study, and we also assessed both the noses and the eyeballs of selected mice microscopically at study termination. Animal Health. Of the 1,320...

Jan L Ottesen

The Expert Group on Rodents and Rabbits of the Council of Europe has clearly stated that its objective is to meet the needs of animals. As part of the extensive background information in the Preamble to their proposal for revision of Appendix A of the European Convention ETS 123, the following statements appear (Stauffacher et al. 2002) The exact numeric values for minimum cage sizes and heights as well as for maximum stocking densities can never be scientifically evaluated and proved. Working...

Species Specific Section Subject Headings

The species-specific sections for dogs and cats covered the following The environment and its control Ventilation Temperature Humidity Lighting Noise Early socialization with conspecifics and humans Substrate, litter, bedding, and nesting material For subject headings that were common to all species-specific sections, the Group decided no proposals were necessary other than those already contained in the General Section. These headings are shown in italics in the list above. Additional headings...

Geneotypes And Environments

As in any area of science, investigators seek to reproduce interesting results of behavioral and other neurobiological experiments with laboratory animals in their own laboratory setting. This generalization of research findings is a crucial part of the scientific process in several ways. Repro-ducibility, in the broad sense, is taken as a sign of reliability. Failures to reproduce a finding can help to prune the literature of false-positive findings. Successful exportation of a finding to...

Methods

The cages we used were Thoren 1 (shoebox, area 67.6 in2) (Thoren Caging Systems, Inc., Hazleton, PA), Thoren 2 (weaning cage, area 112.9 in2), and Thoren 3 (duplex, area 51.7 in2 per side). A total of 540 mice of each sex were included in the 8-week study, and 660 mice of each sex were included in the 4-week study. The densities are coded as follows (1) 12.9 in2 per mouse (2) 8.6 in2 per mouse (3) 6.6 in2 per mouse (4) 5.6 in2 per mouse (5) 4.5 in2 per mouse (6) 3.8 in2 per mouse and (7) 3.2...

Discussion

Based on gross measures, the health and well-being of the mice used in these studies were not affected by cage type or housing density. There were no significant differences among mice housed in three cage types, at any of the seven densities, in growth rates or food and water consumption. We did not observe aggressive or injurious behavior, and all mice survived the 8-week period of the first study. The incidence of alopecia among B6 female mice ranged from 0 to 6 in the 8-week study and was...

Presenter Abigail Smith

The Guide for the Care and Use of Laboratory Animals (the Guide) (NRC 1996) specifies floor space requirements for laboratory mice of different weights. All cages must be at least 5 inches high. Floor space requirements (per mouse) are designated as at least 6 in2 for mice less than 10 g, 8 in2 for mice up to 15 g, 12 in2 for mice up to 25 g, and more than 15 in2 for mice weighing more than 25 g. The few peer-reviewed publications that address floor space needs of laboratory mice suggest that...

Perspective Of Animal Experiments In Japan

In Japan, we seek to combine Buddhist and Christian assumptions and to reach a point where humans should take responsibility for laboratory animals so that they can accomplish good Karma while using the animals for scientific purposes. If animals are suffering from infectious diseases, for example, they will not be able to provide reliable experimental data as their good Karma. Thus, microbiological control of the animal environment should be the responsibility as well as good Karma for people...

William T Greenough and Ann Benefiel

This presentation focuses on the research cost-benefit aspect of enrichment of housing conditions for laboratory rats and mice. The choice of this subject emerged because the session organizers requested a presentation on laboratory animal housing enrichment and included the following in their letter of charge The workshop will . . . focus . . . on identifying gaps in the current knowledge in order to encourage future research endeavors, assessing potential financial and outcome costs of...

Temperature and Humidity

A review of housing guidelines and published data pertaining to temperature and humidity reveals the gaps in our knowledge that make it difficult to specify precise environmental conditions. Most common laboratory animals are adaptive homeotherms and as such make anatomic, metabolic, and physiologic adjustments in response to their environment to maintain well-being. Environmental adaptation in both wild and laboratory animals suggests that consistency in environment may not be normal or...

List of Iclas Members

National members Argentina, Austria, Belgium, Canada, China, Costa Rica, Cuba, Cyprus, Denmark, Finland, Germany, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, South Africa, Spain, Sweden, Thailand, the United Kingdom, the United States, Mexico, and Tunisia. Scientific Union members AALAS USA, ANZLAS Australia-New Zealand, AGS USA, CALAS-ACSAL Canada, CALAS China, GV-SOLAS Germany, JALAS Japan, KALAS Korea, LASA U.K., NVP Netherlands, Scand-LAS...

Breakout Session Effects of Sound on Research Animals

Gaps in our knowledge exist regarding the effects of noise, vibration, and sound for research animals. In this session, Dr. Sherri Motzel, Director of Laboratory Animal Resources at Merck Research Laboratories, presented a scholarly review of the effects of noise, vibration, and sound. The review included definitions, the current regulations and standards for noise, reviews of several relevant studies for rodents and nonhuman primates, and opportunities for noise, sound, and vibration...

The Council Of Europe And The Protection Of Laboratory Animals

As early as 1971, the parliamentary assembly recognized that to protect animals against abusive and unnecessary experimentations certain norms should be established at an international level, to enable states to regulate such experiments in an harmonious way in their domestic law. A first draft of the Convention was elaborated by the Ad Hoc Committee of Experts on the Protection of Animals, the CAHPA. After lengthy discussions, the Convention was finally adopted in May 1985. The Convention is...

Nelson L Garnett

The laws, regulations, and policies in the United States have three main sources of which two are government and one is a private voluntary accreditation body (1) the US Department of Agriculture (USDA), (2) the Department of Health and Human Services, and (3) the American Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). In this presentation, I will focus mostly on the Public Health Service (PHS) contribution, although there are many similarities...

Council Of Europe Convention Ets 123 1986

Council of Europe Convention ETS 123, which dates from 1986, makes provision for the protection of animals produced and used for experimental and other scientific purposes, including both fundamental and applied research. Most members of the European Union, and the Commission itself, have signed and ratified this Convention. Appendix A of the Convention sets minimum provisions for the housing and care of animals. Strictly speaking, those who have ratified the Convention are required only to...

Rapporteurs Primary Jennifer Obernier Secondary Stephen W Barthold

The informal introductory comments of Drs. Baumans and Vandenbergh stimulated immediate discussion. Dr. Baumans discussed the pros and cons of enrichment, emphasizing the necessities for taking into account the normal behavior of each species and for evaluating enrichment methods. Dr. Vandenbergh elaborated on this point noting that guidelines must have a positive strategy they should identify a scientific basis and measure outcome appropriately and they should be performance based. This...

Harry J M Blom

Like farm animals and pets, laboratory animals were originally derived from wild living ancestors. The early scientists started to house and breed those animal species, mainly mammals, which were easiest to maintain under artificial conditions in terms of economics and animal needs. Of course, other criteria also played an important role in the selection process. The species of choice needed to be accurate models for biomedical research, the results of which were to be extrapolated to humans....