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Institutions that conduct high-containment agricultural research involving domestic livestock represent a specialized category of programs that are accredited by AAALAC International. The accreditation process includes a comprehensive assessment of the overall program of animal care and use. However, the complex design of these facilities and the unique care required for animals in this type of environment often mean that additional attention will be directed at areas regarded as higher risk when the programs are evaluated. Specific issues that may stimulate additional discussion and interest include animal housing practices, environmental conditions inside the facility, maintenance of procedure and support areas, methods for obtaining and safely transporting healthy research animals, strategies to minimize animal pain and distress, unusual protocol review challenges, and institutional policies relevant to personnel training and safety. These issues are further discussed to inform institutions of potential concerns that should be reviewed and assessed during internal preparations for accreditation visits by AAALAC site visit teams.

Globalization of the biomedical research enterprise is occurring at an accelerating pace. Increasingly, scientific collaborations and contracts cross national borders. Assurance that the caliber of animal research and animal welfare are consistent among countries and that such animal use is done in a humane and conscientious manner is of significant concern to the scientific community, the general public, and other stakeholders. Bridging these international collaborations is a clear scientific imperative for statistical validity of the data and reproducibility of results to ensure the animal use is both meaningful and impactful. One way to mitigate the potential confounding effects that the welfare of the animals may have on the research data is to harmonize animal care and use practices and procedures worldwide. By harmonizing the care and use of animals, using high standards that are internationally accepted, research animal welfare and high-quality science will be achieved.

The provision of environmental enrichment to numerous species of laboratory animals is generally considered routine husbandry. However, mouse enrichment has proven to be very complex due to the often contradictory outcomes (animal health and welfare, variability in scientific data, etc.) associated with strain, age of the animal when enrichment is provided, gender of the animal, scientific use of the animal, and other housing attributes. While this has led to some suggesting that mice should not be provided enrichment, more recently opinion is trending toward acknowledging that enrichment actually normalizes the animal and data obtained from a mouse living in a barren environment are likely not to be representative or even reliable. This article offers an overview of the types of impact enrichment can have on various strains of mice and demonstrates that enrichment not only has a role in mouse husbandry, but also can lead to new areas of scientific enquiry in a number of different fields.

It has been widely accepted for some time that species-appropriate environmental enrichment is important for the welfare of research animals, but its impact on research data initially received little attention. This has now changed, as the use of enrichment as one element of routine husbandry has expanded. In addition to its use in the care of larger research animals, such as nonhuman primates, it is now being used to improve the environments of small research animals, such as rodents, which are used in significantly greater numbers and in a wide variety of studies. Concern has been expressed that enrichment negatively affects both experimental validity and reproducibility. However, when a concise definition of enrichment is used, with a sound understanding of the biology and behaviour of the animal as well as the research constraints, it becomes clear that the welfare of research animals can be enhanced through environmental enrichment without compromising their purpose. Indeed, it is shown that the converse is true: the provision of suitable enrichment enhances the well-being of the animal, thereby refining the animal model and improving the research data. Thus, the argument is made that both the validity and reproducibility of the research are enhanced when proper consideration is given to the research animal's living environment and the animal's opportunities to express species-typical behaviours.

Many countries, professional organizations, and nongovernmental organizations have issued guidelines for adequate veterinary medical care for laboratory animals. They are thus considered internationally to be an essential component of animal care and use programs. In the United States, the Guide for the Care and Use of Laboratory Animals (the Guide; NRC 1996), a publication of the National Research Council through the Institute for Laboratory Animal Research (ILAR), provides guidelines that serve as the basis for the US Public Health Service Policy on Humane Care and Use of Laboratory Animals. Among the critical topics included in the Guide is veterinary medical care for laboratory animals, and the report’s recommendations outline key fundamental issues for institutions. While the Guide primarily provides guidelines for use in

Increasingly, scientific collaborations and contracts cross country borders. The need for assurance that the quality of animal welfare and the caliber of animal research conducted are equivalent among research partners around the globe is of concern to the scientific and laboratory animal medicine communities, the general public, and other key stakeholders. Therefore, global harmonization of animal care and use standards and practices, with the welfare of the animals as a cornerstone, is essential. In the evolving global landscape of enhanced attention to animal welfare, a widely accepted path to achieving this goal is the successful integration of the 3Rs in animal care and use programs. Currently, awareness of the 3Rs, their implementation, and the resulting animal care and use standards and practices vary across countries. This variability has direct effects on the animals used in research and potentially the data generated and may also have secondary effects on the country's ability to be viewed as a global research partner. Here we review the status of implementation of the 3Rs worldwide and focus on 3 countries–Brazil, China and India–with increasing economic influence and an increasing footprint in the biomedical research enterprise.

The use of animals in research, testing, and education is subject to a myriad of laws, regulations, policies, and standards. The public’s interest in the treatment of laboratory animals and lobbying by animal welfare and antivivisection organizations has led to the passage of many of these laws and regulations during the second half of the 20th century. However, the research community’s need for reliable data obtained from laboratory animals in the most humane manner has also helped ensure a high level of welfare and the ethical use of these animals. Good husbandry practices, veterinary care, animal facility management, and laboratory techniques in the context of the 3Rs (Replacement, Refinement, and Reduction) are all necessary to promote the quality of scientific results.

There are many opportunities to benefit science and business through application of the “3 Rs” (replacement, reduction, and refinement) to nonhuman primate use in drug development and safety assessment studies. Scientifically driven approaches that consider individual studies on a case-by-case basis and how these studies fit into the drug development program as a whole can reduce the number of animals used without affecting the development outcome. Some examples include minimizing the number of dose groups, the number of animals per group, and the inclusion of recovery animals. In addition, studies that involve nonhuman primates can be refined through spacious and well-designed accommodation, effective environmental enrichment, housing in stable social groups, well-trained staff, use of the best humane technical practices, and positive reinforcement training of the animals to cooperate with procedures. All the elements within this chapter are interlinked and support improved animal welfare to generate more robust and reliable data to predict human safety.

The IACUC is one of the most important committees at a research institution and plays a critical role in the success of an animal care and use program. It is the responsibility of the institution to provide IACUC members with adequate and appropriate training. The authors explore various IACUC training options.

The impact on welfare of the numerous characteristics of the living environment of a laboratory animal has received increasing attention in recent years. The standard research animal housing design of a box (the cage), within a bigger box (the animal room), within an even bigger box (the animal facility), has undergone transformation at many institutions, with the result that animals are often afforded more vertical space, access to the outdoors, windows to the outside, and many other design features (depending upon the species) that break from tradition. The living environment is typically considered to be comprised of physical, chemical, and biological factors that may have synergistic or competing effects on the welfare of an animal. Other less tangible aspects, such as enclosure space, social complexity, and the human factor play a critical role in laboratory animal welfare but pose special challenges to interpret their precise effects in the milieu of other environmental features. As efforts to optimize laboratory animal welfare through improved living environments, exemplified by the expanding emphasis on social housing and other forms of environmental enrichment, gain momentum in the industry, innovation and new technologies balanced with safety considerations for the animal and the personnel, animal management (e.g. animal observation, access to the animal), and the research objectives predominate. This chapter delineates key factors in the living environment that impact animal welfare with a view to highlighting areas that are well understood in terms of the impact on welfare and those that necessitate further research and more creativity.

China has developed into a significant world economy, evidenced in part by its strong commitment to supporting biomedical research as a key economic engine and an increasingly dominant role in the global life sciences landscape. Numerous institutions in diverse countries are partnering with China through outsourcing and collaborations for animal-based research and testing objectives. The research and laboratory animal veterinary communities share an interest in the standards of animal care and use applied in institutions throughout China. Yet, little is known about the complex set of regulations governing the use of animals in research, in part due to language obstacles—with English translations of the information scarce—or because of challenges to the non-Chinese scientist or veterinarian in finding the information. In addition, the regulatory environment in China is evolving and thus it is challenging to stay current on the regulations. This chapter aims to provide a comprehensive review of the regulatory environment in China as a single source to facilitate understanding of the country's regulations today with indications of how the regulations are changing.

I n this issue of the ILAR Journal we present lessons learned by colleagues who experienced different types of disasters, both natural and deliberate, in varying animalrelated settings. The authors recount their experiences with a variety of types of disaster not only at research facilities—a devastating hurricane and tropical storm (Goodwin and Donaho 2010), violent threats from animal rights activists (Bailey et al. 2010), even persistent viral outbreaks in a laboratory rodent colony (Smith 2010)—but also at an animal shelter (wildfi re evacuation; Arms and Van Zante 2010) and a poultry farm (avian infl uenza containment; Flory and Peer 2010). We hope the information will be of practical use for extrapolation to a variety of situations.

The fundamental raison d’etre of the laboratory animal veterinarian, institutional animal care and use committee (IACUC 1 ), IACUC administrator, institutional compliance office/officer, training coordinator, and other related positions and groups at institutions that use animals for research, testing, and teaching is to ensure the humane, responsible, and productive use of animals in those activities. All of these people and groups support both science and animal welfare. The US system of animal welfare oversight has been covered in several review articles in recent years (Garnett 2005; NRC 2003), and all of the authors in this issue of the ILAR Journal allude to or cite key components of the policy and regulatory framework of oversight. Therefore, rather than an exhaustive review, we provide here a brief summary of the relevant documents and oversight bodies. The Animal Welfare Act (AWA) regulations (9 CFR), enforced by the US Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Animal Care unit, apply to registered research facilities that use species covered under the act. The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, authorized by the Health Research Extension Act (HREA), is implemented by the National Institutes of Health’s (NIH) Office of Laboratory Animal Welfare (OLAW 1 ) and is applicable to all PHS-supported activities involving live vertebrate animals. The PHS Policy includes, by reference, the NRC Guide for the Care and Use of Laboratory Animals (the Guide; NRC 1996). Eligibility for NIH (and other PHS) grant and contract support requires compliance with the

Oversight of laboratory animal care and use in the research environment is multilayered. Federal and state regulations apply to many laboratory animal species; funding agencies frequently require adherence to additional guidelines; institutions may develop in-house policies; and an institution may choose to voluntarily participate in an accreditation program, indicating a commitment by the institution to apply the most rigorous standards to the animal care and use program. In general, regulations follow a prescriptive “engineering” approach, while guidelines applied to the care and use of research animals follow a “performance” approach, which defines the desired outcome in detail, but acknowledges that multiple methods may achieve that outcome. The performance approach relies on sound professional judgment, thereby allowing flexibility based on an institution's unique circumstances. Further, this approach should facilitate the international harmonization of animal care and use standards. The performance, or outcome, approach to developing guidelines is described, using the Guide for the Care and Use of Laboratory Animals (NRC, 1996) as the model.

In the past few years, new social passions have sparked on the Chinese mainland. At the centre of these burgeoning passions is a focus on animal welfare, animal treatment, and even animal rights, by the public and academic sectors. With China's rapid economic changes and greater access to information from around the world, societal awareness of animal issues is rising very fast. Hastening this paradigm shift were several highly public incidents involving animal cruelty, including exposés on bear bile harvesting for traditional Chinese medicine, the thousands of dogs rescued from China's meat trade, and the call to boycott shark fin soup and bird nest soup. This article outlines the current status of campaigning by animal advocates in China (specifically the animal rights movement) from three interlinked perspectives: wildlife conservation, companion animal protection, and laboratory animal protection. By reviewing this campaigning, we attempt to present not only the political and social impact of the concept of animal rights, but also the perceptions of, and challenges to, animal rights activities in China.

The use of animals in research, testing, and teaching is a global enterprise, but the issues facing such use vary regionally as well as in specific countries. This chapter addresses several trends in laboratory animal welfare that cut across country borders such as training of veterinarians in laboratory animal medicine, implementation of the Three Rs, issues surrounding outsourcing/offshoring animal use, harmonization efforts in the care and use of laboratory animals, how the availability of various medications and diagnostic test kits may affect welfare, the increasing implementation of environmental enrichment across species and countries, concerns regarding transportation of laboratory animals, increasing attention to laboratory animal welfare, and other topics of overarching significance. The status of these subjects in various countries is described to illustrate the complexity of the global landscape of research animal welfare, to underscore the progress that has been made in enhancing welfare, and to highlight the variety of welfare concerns being considered and addressed.

Nonhuman primates housed in captivity can exhibit many different kinds of abnormal behavior that vary in severity, ranging from pacing to self-inflicted wounding. A number of factors have been shown to increase the risk of developing abnormal behavior. A particularly vulnerable period is infancy, and early rearing environments can have a profound effect on species’ normative trajectories, leading to poor social outcomes, stereotypic behavior, and increased anxiety. Older primates can also develop abnormal behavior, particularly when removed from social companions and placed into individual cage housing. Not all monkeys housed in individual cages develop abnormal behavior and increased risk is associated with age of onset, exposure to stressful events, and genetic factors. No single treatment has proven to be effective in eliminating even the most severe forms of abnormal behavior, in part because of different possible etiologies. In some cases, abnormal behavior can be viewed as maladaptive, either relating to some biological dysfunction (disease model) or psychiatric disorder (psychopathology model). In other cases, abnormal behavior can be viewed as a coping strategy either because it increases the levels of stimulation (do-it yourself enrichment model) or decreases anxiety (arousal reduction model). Common treatment approaches include social housing, environmental enrichment, positive reinforcement training, and in severe cases, pharmacotherapy. A practical guide to recognizing, characterizing, and ruling out disease-related processes is presented. Options for prevention and treatment are discussed.

Around the world there are laws, regulations, treaties, conventions, policies and organizational and other requirements to the use of many species in biomedical research but there are also often further specific requirements for nonhuman primates. These specific requirements result from a number of factors including species differences, political initiatives, cultural and social perspectives, medical needs, moral and ethical concerns, concerns on capacity for pain and distress, animal and human health controls, health and safety requirements, programs to assure supply, and measures for species conservation. These requirements are summarized as they must be understood by those involved in the care and use of nonhuman primates in biomedical research.

Because some trainees are not university employees, regulatory agencies, oversight committees, and investigators may overlook those who work with animals when it comes to training related to animal care and use. The authors draw attention to a common problem facing universities and suggest ways to close the gap in training.

Many aspects of the research animal's housing environment are controlled for quality and/or standardization. Of recent interest is the potential for environmental enrichment to have unexpected consequences such as unintended harm to the animal, or the introduction of variability into a study that may confound the experimental data. The effects of enrichment provided to nonhuman primates, rodents, and rabbits are described to illustrate that the effects can be numerous and may vary by strain and/or species. Examples of parameters measured where no change is detected are also included because this information provides an important counterpoint to studies that demonstrate an effect. In addition, this review of effects and noneffects serves as a reminder that the provision of enrichment should be evaluated in the context of the health of the animal and research goals on a case-by-case basis. It should also be kept in mind that the effects produced by enrichment are similar to those of other components of the animal's environment. Although it is unlikely that every possible environmental variable can be controlled both within and among research institutions, more detailed disclosure of the living environment of the subject animals in publications will allow for a better comparison of the findings and contribute to the broader knowledge base of the effects of enrichment.

An interview with Kathryn Bayne, MS, PhD, DVM, DACLAM, CAAB, Global Director, Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International, Frederick, MD.

Publisher Summary This chapter discusses the nature and extent of behavioral disorders in nonhuman primates. It examines the possible physiological and environmental determinants of the behavioral pathology in nonhuman primates. Abnormal behavior in nonhuman primates often takes the form of stereotypic behavior—that is, a repetitive, frequently idiosyncratic, highly ritualized action that does not serve any apparent biological purpose. Nonhuman primates can exhibit intense and severe forms of abnormal behavior that can potentially yield tissue irritation or damage. Several possible therapeutic interventions and preventative approaches to abnormal behavior are also discussed in the chapter. One of the most common means of determining if a nonhuman primate is afflicted with a psychological disorder involves monitoring the behavioral repertoire of that animal for the occurrence of potentially maladaptive patterns. The development of normal behavior in nonhuman primates is critically dependent on the way a primate is reared during infancy.