Animal Welfare Considerations Research Articles

P.6.a.007 - Effects of excessive alcohol drinking on metabolic processes in rats’ brain

Food security and sustainability are paramount goals of global policy in the Twenty First Century. What are the contributions of applied ethology and animal welfare in delivering these major goals? Livestock plays a major role in food security and nutrition (FSN), because meat and animal products are important in people’s diets and the livestock sector is central to food systems’ development. And many aspects of the welfare of livestock are important for production, as expressed in the advice, ‘Look after your animals and they will look after you,’ for example, reduction of disease. Consideration of animal welfare can enable advantages for production that have not otherwise been identified, and is therefore not just compatible with but important for achieving good management of livestock for production, livelihoods and FSN. Furthermore, understanding of animal behaviour and care for livestock welfare contribute to all three pillars of sustainable agriculture: economic profitability, social equity and environmental health. Ethology clarifies the interactions between animals, humans and the environment, and thus helps to optimise livestock management for the best balance between these complex priorities. However, although considering behaviour and welfare is valuable for production and FSN, people do not always recognise or act on this value. They may need information or help to do so: mechanisms are needed to provide information, help and sometimes financial assistance to producers. These mechanisms need input from experts in applied ethology and animal welfare, at both practical and policy level.Six policy areas are briefly outlined. Each requires (to a variable degree) understanding of animal behaviour and welfare and implementation of that understanding. (1) Development of humane, sustainable food security strategies; (2) Promotion of humane, sustainable livestock systems; (3) Reduction of livestock reliance on human-edible arable crops, especially cereals; (4) Development of specific food and livestock policies to assist vulnerable sectors of the population; (5) Sustainable diets; and (6) Development of markets for humane, sustainable livestock production.Urgent efforts are needed to achieve food security and sustainability, by producers, governments and intergovernmental organisations in consultation with other stakeholders including scientists and non-governmental organisations. The livestock sector has both positive and negative impacts. Consideration of animal behaviour and welfare helps to ensure and increase the positive impacts, and to reduce and avoid the negative, and should therefore be a priority for countries worldwide.

Immunocastration as an alternative to caponization: evaluation of its effect on body and bone development and on meat color and composition

Caponization is associated with some morbidity and mortality, which contributes to important economic losses. This practice is executed without any pain relief (neither anesthesia nor analgesia) and can be painful and without consideration of animal welfare. On the other hand, immunocastration accomplished by Improvac and Bovipriva in pigs and cattle represents a noninvasive procedure, and for that reason is regarded as an alternative with improved animal welfare. This study includes 4 experimental groups consisting of capons, slips, roosters, and birds submitted to the Improvac treatment. The administration of Improvac was associated with a considerable reduction in serum testosterone concentration (reduced by 79% compared to average serum testosterone of roosters). Regarding significant differences among experimental groups, birds from the Improvac group were intermediate between capons and slips with respect to abdominal fat pad weight and yield, breast meat water and protein contents, and femur length. Conversely, color parameters such as lightness, redness, and hue angle for Improvac birds were intermediate between roosters and capons. Thus, immunocastration with Improvac could represent an alternative solution to caponization, with considerable improvements in animal welfare.

Review

The purpose of this review is to evaluate and report current finished cattle road transportation on animal health and welfare and carcass quality within the United States and Canada. Reviewed literature was divided into the 5 distinct categories of: 1) microclimate; 2) loading density; 3) duration of transport; 4) quality of transport; and 5) animal behavior. These 5 factors influence animal health, welfare, and carcass quality considerations, resulting in differing levels of manipulation and understanding within the reported literature. Duration, loading density, and animal behavior effects are more easily defined than those of microclimate and transport quality. Altering 1 of the factors can have an unintended impact on another, thus causing less defined results. These factors and their interactions must be further evaluated to fully understand the impact these stressors have on animal welfare and economic return. The objectives of this review were to compile previous literature and identify research areas that will further improve cattle transportation.

Husbandry practices and gut health outcomes in weaned piglets: Areview.

The immediate post-weaning period is one of the most stressful phases in a pig's life, and during this period, piglets are usually exposed to environmental, social and psychological stressors which have direct or indirect effects on gut health and overall growth performance. In this review, the impact of husbandry practices on gut health outcomes and performance of piglets is discussed. Husbandry practices in the swine barn generally include nutrition and management practices, maintenance of hygienic standards and disease prevention protocols, and animal welfare considerations. Poor husbandry practices could result in reduced feed intake, stress and disease conditions, and consequently affect gut health and performance in weaned piglets. Reduced feed intake is a major risk factor for impaired gut structure and function and therefore a key goal is to maximize feed intake in newly weaned piglets. In weaned piglets, crowding stress could reduce pig performance, favor the proliferation of pathogenic bacteria resulting in diarrhea, stimulate immune responses and interfere with beneficial microbial activities in the gut. Sanitation conditions in the swine barn plays an important role for optimal piglet performance, because unclean conditions reduced growth performance, shifted nutrient requirements to support the immune system and negatively affected the gut morphology in weaned piglets. Appropriate biosecurity measures need to be designed to prevent disease entry and spread within a swine operation, which in turn helps to keep all pigs and piglets healthy. Collectively, husbandry practices relating to feeding and nutrition, animal welfare, biosecurity and disease prevention are important determinants of gut health and piglet performance. Thus, it is suggested that adopting high husbandry practices is a critical piece in strategies aimed at raising pigs without the use of in-feed antibiotics.

Safety Assessment of Food and Feed from GM Crops in Europe: Evaluating EFSA's Alternative Framework for the Rat 90-day Feeding Study.

Regulatory-compliant rodent subchronic feeding studies are compulsory regardless of a hypothesis to test, according to recent EU legislation for the safety assessment of whole food/feed produced from genetically modified (GM) crops containing a single genetic transformation event (European Union Commission Implementing Regulation No. 503/2013). The Implementing Regulation refers to guidelines set forth by the European Food Safety Authority (EFSA) for the design, conduct, and analysis of rodent subchronic feeding studies. The set of EFSA recommendations was rigorously applied to a 90-day feeding study in Sprague-Dawley rats. After study completion, the appropriateness and applicability of these recommendations were assessed using a battery of statistical analysis approaches including both retrospective and prospective statistical power analyses as well as variance-covariance decomposition. In the interest of animal welfare considerations, alternative experimental designs were investigated and evaluated in the context of informing the health risk assessment of food/feed from GM crops.

Laboratory Animal Welfare. American College of Laboratory Animal Medicine Series. Edited by Kathryn Bayne and Patricia V. Turner. Academic Press. Amsterdam (The Netherlands) and Boston (Massachusetts): Elsevier. $199.95. xv + 318 p.; ill.; index. ISBN: 978-0-12-385103-1. 2014.

Previous articleNext article FreeHistory, Philosophy, and Ethics of BiologyLaboratory Animal Welfare. American College of Laboratory Animal Medicine Series. Edited by Kathryn Bayne and Patricia V. Turner. Academic Press. Amsterdam (The Netherlands) and Boston (Massachusetts): Elsevier. $199.95. xv + 318 p.; ill.; index. ISBN: 978-0-12-385103-1. 2014.Kyha D. WilliamsKyha D. WilliamsLaboratory Animal Resources, Duke University, Durham, North Carolina Search for more articles by this author Laboratory Animal Resources, Duke University, Durham, North CarolinaPDFPDF PLUSFull Text Add to favoritesDownload CitationTrack CitationsPermissionsReprints Share onFacebookTwitterLinked InRedditEmailQR Code SectionsMoreIn general, this book provides a very organized and detailed review of laboratory animal welfare and associated topics, regulations, and guidelines. The manner in which the chapters are designed and the layout of the print facilitate quick reference and review and enhance the reading experience. Of particular note are Chapters 3 (Regulations, Policies, and Guidelines Impacting Laboratory Animal Welfare), 4 (Animal Welfare Assessment Considerations), 8 (Experimental Design: Reduction and Refinement in Studies Using Animals), 9 (Animal Welfare Considerations in Biomedical Research and Testing), and 10 (Preservation of Animal Welfare During Unforeseen Events). Many concepts by the nature of the subject matter are interconnected, but the volume does include frequent chapters where the information, although presented in a slightly different manner, is redundant. This is particularly true for the overuse of the 3Rs concept across multiple chapters. Some chapters could potentially have been combined to streamline information.Despite that, this book would serve as a valuable resource for any laboratory animal veterinarian and for those preparing for specialty board examinations—i.e., American College of Laboratory Animal Medicine (ACLAM) and American College of Animal Welfare (ACAW). The extensive and varied backgrounds of the authors of each chapter are also impressive and provide validity for the text. Further, the breakdown by species (including the five primary as outlined by the ACLAM Role Delineation Document, as well as others) provides many practical applications of the concepts, philosophies, and information presented in the preceding chapters. This further supports the use of this volume as a programmatic reference for facilities and institutions that use animals for biomedical and translational research, teaching, and testing. Previous articleNext article DetailsFiguresReferencesCited by The Quarterly Review of Biology Volume 92, Number 1March 2017 Published in association with Stony Brook University Article DOIhttps://doi.org/10.1086/690843 For permission to reuse, please contact [email protected]PDF download Crossref reports no articles citing this article.

Why management decisions involving marine mammals should include animal welfare

This paper argues the need for consideration of both animal welfare and conservation when making management decisions regarding human activities that affect marine mammals. Population level effects may take a long time to be determined, whereas animal welfare metrics can be observed in the short term, enabling problems to be addressed more rapidly. In addition, implementing current legislation in many countries related to the management of impacts on marine mammals requires animal welfare to be taken into account. Such legislation reflects societal values and public concern for individual animals. Two case studies are discussed. These are: management measures related to incidental killing in commercial fisheries, and injury or disturbance from intense sources of underwater noise from seismic surveys. Both of these threats have welfare and conservation implications for marine mammals. An increased focus on welfare would better reflect societal values including requirements under various legal regimes and could also enable more targeted and effective conservation actions.

Justice Is the Missing Link in One Health: Results of a Mixed Methods Study in an Urban City State.

BackgroundOne Health (OH) is an interdisciplinary collaborative approach to human and animal health that aims to break down conventional research and policy ‘silos’. OH has been used to develop strategies for zoonotic Emerging Infectious Diseases (EID). However, the ethical case for OH as an alternative to more traditional public health approaches is largely absent from the discourse. To study the ethics of OH, we examined perceptions of the human health and ecological priorities for the management of zoonotic EID in the Southeast Asia country of Singapore.MethodsWe conducted a mixed methods study using a modified Delphi technique with a panel of 32 opinion leaders and 11 semi-structured interviews with a sub-set of those experts in Singapore. Panellists rated concepts of OH and priorities for zoonotic EID preparedness planning using a series of scenarios developed through the study. Interview data were examined qualitatively using thematic analysis.FindingsWe found that panellists agreed that OH is a cross-disciplinary collaboration among the veterinary, medical, and ecological sciences, as well as relevant government agencies encompassing animal, human, and environmental health. Although human health was often framed as the most important priority in zoonotic EID planning, our qualitative analysis suggested that consideration of non-human animal health and welfare was also important for an effective and ethical response. The panellists also suggested that effective pandemic planning demands regional leadership and investment from wealthier countries to better enable international cooperation.ConclusionWe argue that EID planning under an OH approach would benefit greatly from an ethical ecological framework that accounts for justice in human, animal, and environmental health.

The effects of welfare-related management practices on carcass characteristics for beef cattle

The improvement of farm animal welfare through management practices has become important despite the fact that there is a conflict between animal welfare and production efficiency. It may be possible to find associations between production and management practices related to animal welfare, such as management strategies to enhance both production and animal welfare. The objective of the present study was to investigate the effect of different fattening management practices with respect to animal welfare on the carcass characteristics in Japanese beef cattle fattening systems at the farm level. The face-to-face interview survey on welfare-related management practices was conducted with 30 beef fattening farmers who sold more than 5 animals from July 2014 to March 2015 in the carcass market in Shiga Prefecture. The best linear unbiased predictors of each farm (the so-called farm BLUP) for carcass traits (carcass weight, CWT; marbling score, BMS; longissimus muscle area, LMA; rib thickness, RT; and subcutaneous fat thickness, SFT) and carcass unit price (CUP) were estimated from the data collected at the carcass market. The effect of management practices on farm BLUPs for carcass traits and CUP were tested using one-way ANOVA. For management practices, there were significant effects of routine claw trimming on farm BLUP for SFT (P<0.05), dehorning for CUP (P<0.05), and nose ring for BMS (P<0.05) and CUP (P<0.01). In Japan, some farmers who purchased stock calves at the calf markets maintain them in isolated pens before grouping them at the start of fattening, and this management had a significant effect on farm BLUPs for RT (P<0.05), CWT, and LMA (P<0.01). Likewise, the equipment of additional identification tags had a significant effect on farm BLUP for CWT (P<0.05). For housing management, the floor type significantly affected the farm BLUP for LMA (P<0.05). These results suggest that the consideration of animal welfare at the farm level in beef fattening systems might improve the quantity and quality of the beef produced.

Effects of varying floor space on aggressive behavior and cortisol concentrations in group-housed sows.

Floor space is an important determinant of aggression and stress in group-housed sows, and the aim of the present experiment was to comprehensively examine the effects of floor space in the range of 1.45 to 2.90 m/sow from mixing until 27 d after insemination on aggression, stress, and reproduction of group-housed sows. A previous experiment on the effects of floor space indicated spatial variability across and along the research facility in both sow aggression and stress. To minimize this spatial variability within the research facility, similar-sized pens but with varying groups sizes (10-20) in 4 separate blocks of 3 contiguous pens within each of 9 time replicates (180 sows/replicate) were used to examine 6 space allowances (1.45-2.9 m/sow). Space treatments were appropriately randomized to pens. Although it may be argued that space allowance is confounded with group size in this design, there was no evidence in our previous experiment of group size effects, for pens of 10 to 80 sows, or appreciable interactions between space and group size on aggression, stress, and reproduction. In the present experiment, sows were introduced to treatments within 4 d of insemination and were floor fed 4 times per day (2.5 kg/sow per d). On both Days 2 and 26 after mixing, aggressive behavior (bites and knocks) at feeding and plasma cortisol concentrations were measured. Restricted maximum likelihood mixed model analyses were used to examine the treatment effect after accounting for replicate and random spatial location effects within replicate. There was a consistent linear effect of floor space allowance on aggression at feeding at Day 2 ( < 0.0001) and plasma cortisol concentrations at Day 2 ( = 0.0003), with aggression and stress declining with increasing space. However, there were no effects of space allowance on aggression and stress at Day 26 ( = 0.14 and = 0.79, respectively). These results show that increased floor space in the immediate post-mixing period reduces aggression and stress and that sows may adapt to reduced floor space over time. A strategy of staged-gestation penning, with more space immediately after mixing and less space later in gestation, may address both animal welfare and economic considerations, but this clearly requires further examination.

Technology and Poultry Welfare

Consideration of animal welfare is essential to address the consumers’ demands and for the long term sustainability of commercial poultry. However, assessing welfare in large poultry flocks, to be able to detect potential welfare risks and to control or minimize its impact is difficult. Current developments in technology and mathematical modelling open new possibilities for real-time automatic monitoring of animal welfare and health. New technological innovations potentially adaptable to commercial poultry are appearing, although their practical implementation is still being defined. In this paper, we review the latest technological developments with potential to be applied to poultry welfare, especially for broiler chickens and laying hens. Some of the examples that are presented and discussed include the following: sensors for farm environmental monitoring, movement, or physiological parameters; imaging technologies such as optical flow to detect gait problems and feather pecking; infrared technologies to evaluate birds’ thermoregulatory features and metabolism changes, that may be indicative of welfare, health and management problems. All these technologies have the potential to be implemented at the commercial level to improve birds’ welfare and to optimize flock management, therefore, improving the efficiency of the system in terms of use of resources and, thus, long term sustainability.

Physiological stress coping and anxiety in greyhounds displaying inter-dog aggression

Aggression is a relatively common behavioural problem in dogs that has both animal welfare and human safety considerations. Understanding the behavioural and physiological processes contributing to aggression is required for a better understanding of this issue. Previous studies have examined levels of anxiety and stress in the presence of aggression eliciting stimuli, however we aimed to measure stress and anxiety in a context unrelated to aggressive behaviour. We recorded the behaviour of greyhound dogs in an open field and noise stimulus paradigm as a measure of anxiety. During a routine blood donation procedure in the dogs, physiological measures of heart rate variability and cortisol release associated with stress coping were recorded. Finally, dogs were then subject to an aggression test where their reaction to an unfamiliar dog was recorded. Greyhounds that displayed aggression to the unfamiliar dog had a significantly greater increase in salivary cortisol in response to the bleeding procedure (0.97ng/ml, 95% CI 0.11–1.83, P=0.029). Heart rate measures also differed, with aggressive dogs having an elevated initial heart rate (18.0bpm, 95% CI 8.4–27.7, P<0.001) and reduced heart rate variability in the low (−1088.7ms2, 95% CI −2114.4 to −63.1, P=0.038) and very low (−7625.5ms2, 95% CI −12193.0 to −3058.0, P=0.002) frequency spectra. No difference in anxiety-related behaviour in the open field and noise stimulus test was detected between groups. These findings demonstrate that measurable differences in physiological stress coping during bleeding exist between greyhound dogs that pass or fail an aggression test in a separate context with an unfamiliar dog.

ADVANCES IN ANIMAL WELFARE FOR FREE-LIVING ANIMALS.

Over several decades, animal welfare has grown into its own free-standing field of scientific study, from its early beginnings in laboratory animal research to eventually include exhibited animals and farm animals. While it has always been present to some degree, consideration of animal welfare for free-ranging animals has lagged behind, developing as a field of study in the last 20 yr or so. Part of that increase was that animal welfare legislation was finally applied to studies being done on free-ranging animals. But it is the appreciation by the biologists and veterinarians working on wild animals, in which the quality of their results is largely controlled by the quality of the animals they use in their studies, which has resulted in increased attention to the well-being or welfare of the animals that they use. Other important influences driving the recognition of wildlife welfare have been changes in the public's expectations of how wild animals are dealt with, a shift in focus of wildlife professionals from managing animals that can be hunted or angled to include nongame species, the decrease in participation in hunting and fishing by members of the public, and the entry of large numbers of women into fish and wildlife agencies and departments and into veterinary medicine. Technical improvements have allowed the safe capture and handling of large or dangerous animals as immobilization drugs and equipment have been developed. The increasing use of sedating drugs allows for handling of animals with reduced stress and other impacts. A number of topics, such as toe-clipping, branding, defining which taxa can or cannot feel pain, catch-and-release fishing, and more, remain controversial within wildlife science. How we treat the wild animals that we deal with defines who we are as wildlife professionals, and animal welfare concerns and techniques for free-ranging animals will continue to develop and evolve.

Wild animal suffering and vegan outreach

Ng’s strategic proposal seems to downplay the potential benefits of advocacy for wild animals and omit what may be the most effective strategy to reduce the harms farmed animals suffer: vegan outreach. Eze Paez, lecturer in moral and political philosophy at Pompeu Fabra University, Barcelona, studies normative and applied ethics, especially ontological and normative aspects of abortion and the moral consideration of nonhuman animals. He is a member of Animal Ethics. upf.academia.edu/ezepaez Underestimating the importance of wild animal suffering. Ng’s (2016) view is not that animal advocates should focus only on farmed animals, to the exclusion of those that live in the wild. He concedes that our efforts must also be directed toward raising awareness of the harms suffered by animals in nature. Nonetheless, he seems to suggest that these efforts should be minimal relative to those devoted to reducing the harms farmed animals suffer. Ng underestimates the potential benefits of advocacy for wild animals in terms of net reduction in suffering perhaps because he is overestimating people’s resistance to caring about wild animals and to intervening in nature on their behalf. He may also be underestimating the magnitude and moral importance of wild animal suffering, even though in 1995 it was Ng himself who emphasized the predominance of suffering over positive wellbeing in nature. In 2016 Ng writes that “we should put [...] more [emphasis] on the environment and true welfare for both humans and other animals”; that “[t]he additional consideration of animal welfare further strengthens the case for greater conservation and against environmental disruption”; and that “it may be that environmental and animal welfare protection is not really costly at all.” Here Ng is implicitly assuming that environmental conservation and the reduction of animal suffering are compatible aims. That may be true regarding the suffering of farmed animals. But it appears to be at odds with Ng’s own analysis (1995), according to which suffering vastly outweighs positive well-being in the lives of wild animals. Omitting vegan outreach. According to Ng (2016) “the initial focus of animal welfare advocates [should] be on reducing the enormous gratuitous suffering in factory farming.” He is concerned to find the most effective strategies for achieving that aim. Yet of the several potential regulations he considers, only one is related to factory farming (better regulation Animal Sentience 2016.087: Paez Commentary on Ng on Animal Suffering 2 of the chicken industry). There is one other example from the food industry (fish mongers), but it concerns small-scale local practices rather than factory farming. One wonders why Ng focuses on such examples to further what he regards as our initial priority rather than other strategies, affecting many more animals. Perhaps this is because Ng is only concerned in this paper with strategies for reducing suffering through institutional change (e.g., legal reform). Within the set of regulation-oriented strategies, those he mentions might indeed be the most cost-effective ones to pursue. Yet if our goal is to reduce the suffering of farmed animals, other strategies might be more beneficial. Analyses by meta-charities suggest that vegan outreach is a more effective strategy to help farmed animals. This is the strategy of convincing individuals that they must cease to consume animal products, for the sake of the animals themselves. The costs of lobbying to achieve legal reform are simply too high, and the gains in nonhuman wellbeing too low in comparison. Presently, through legal reform one can only hope to attain better regulations against cruelty, or a prohibition of practices which affect relatively few individuals (such as foie gras production). In contrast, according to the estimates of Animal Charity Evaluators, with merely $1,000 an organisation dedicated to vegan outreach would spare 13,200 animals from suffering and dying in the industry (Animal Charity Evaluators, 2014). The kind of advocacy Ng proposes can make a difference for many animals. But vegan outreach may have a greater impact, both for short-term behavioural changes and long-term attitudinal ones. This suggests that, in line with Ng’s own aims, what we ought to do for farmed animals is the most effective vegan outreach possible.

Invited review: Influence of climatic conditions on the development, performance, and health of calves

The objective of this review is to provide the reader with an overview of thermoregulatory mechanisms and the influence of climatic conditions in different housing systems on the development, performance, and health of calves. Thermic stress is observed in association with extreme temperatures and large temperature variations, but other variables such as relative humidity and wind speed can also contribute to thermic stress. Thermoregulation in calves is similar to that in adult cattle, but especially dystocial calves are more prone to heat loss. Heat or cold stress results in direct economic losses because of increased calf mortality and morbidity, as well as indirect costs caused by reduced weight gain, performance, and long-term survival. The climatic conditions in a variety of housing systems, associated health problems, and strategies to mitigate thermic stress are discussed in this review. The goal of housing is to alleviate the effect of climate on calves and provide a microclimate. Adequate ventilation with fresh air is essential to reduce respiratory disease. Common practices such as raising calves in individual outdoor enclosures have been challenged lately. Recent research seeks to evaluate the suitability of group housing under practical, economic, and animal welfare considerations. Limited results for reducing thermic stress can be achieved by simple measures such as shades or shelter, but additional heat or cold stress relieving strategies can be required depending on the housing system.

Detecting Preference and Motivation for Environmental Resources: An Animal Welfare Approach

Animal Welfare Science began to gradually develop in the 60´s, probably as a consequence of the publication of the book “Animal Machines” by Ruth Harrison [1], which denounced several practices that were done without regard for animal suffering. Since then, much research has been conducted aiming to identify the welfare states of animals. Firstly, an animal was considered to have good welfare when it was physically healthy, feeding, and producing well. Everyone can easily understand the importance of these characteristics and believe they may be part of animal welfare considerations, but welfare may not be restricted to this. How the animal behaves may also indicate if it is in a better or a worse condition. Thus, a healthy and productive animal or even an animal that is feeding well may be in a poor welfare condition if it is, for example, expressing some stereotypic behaviour. Stereotypies are defined as a series of movements regularly repeated with no apparent purpose or goal [2], probably induced by frustration, repeated attempts to cope and/or brain dysfunction.

Regulatory Acceptance of Alternative Methods in the Development and Approval of Pharmaceuticals.

Animal studies may be carried out to support first administration of a new medicinal product to either humans or the target animal species, or before performing clinical trials in even larger populations, or before marketing authorisation, or to control quality during production. Ethical and animal welfare considerations require that animal use is limited as much as possible. Directive 2010/63/EU on the protection of animals used for scientific purposes unambiguously fosters the application of the principle of the 3Rs when considering the choice of methods to be used.As such, today, the 3Rs are embedded in the relevant regulatory guidance both at the European (European Medicines Agency (EMA)) and (Veterinary) International Conference on Harmonization ((V)ICH) levels. With respect to non-clinical testing requirements for human medicinal products, reduction and replacement of animal testing has been achieved by the regulatory acceptance of new in vitro methods, either as pivotal, supportive or exploratory mechanistic studies. Whilst replacement of animal studies remains the ultimate goal, approaches aimed at reducing or refining animal studies have also been routinely implemented in regulatory guidelines, where applicable. The chapter provides an overview of the implementation of 3Rs in the drafting of non-clinical testing guidelines for human medicinal products at the level of the ICH. In addition, the revision of the ICH S2 guideline on genotoxicity testing and data interpretation for pharmaceuticals intended for human use is discussed as a case study.In October 2010, the EMA established a Joint ad hoc Expert Group (JEG 3Rs) with the mandate to improve and foster the application of 3Rs principles to the regulatory testing of medicinal products throughout their lifecycle. As such, a Guideline on regulatory acceptance of 3R testing approaches was drafted that defines regulatory acceptance and provides guidance on the scientific and technical criteria for regulatory acceptance of 3R testing approaches, including a process for collection of real-life data (safe harbour). Pathways for regulatory acceptance of 3R testing approaches are depicted and a new procedure for submission and evaluation of a proposal for regulatory acceptance of 3R testing approaches is described.

A star attraction: The illegal trade in Indian Star Tortoises

We report on illegal international trade in Indian Star Tortoises (Geochelone elegans), with a particular focus on India and Thailand.Within India, this species has received protection as a Schedule IV list species of the Wildlife (Protection) Act 1972 for over 40 years. This study documents the illegal trade of 55,000 individuals poached from just one ‘trade hub’ in India. Although domestic demand persists, these individuals appear to have been primarily sourced to satiate international demand for pets in other Asian countries (e.g. Thailand and China). Since 1975, this species has been included in Appendix II of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) that regulates all commercial trade. However, an analysis of the CITES trade records relating to Thailand imports (between 2004 and 2013) found large discrepancies indicating potential illegal activity which question the legitimacy of its founding captive stock. Given its role as a major hub of illegal trade activity, both as a consumer and a country of transit, we support calls for Thailand to prohibit private ownership by extending its domestic legislation to also cover non-indigenous tortoise species. In consideration of conservation and animal welfare concerns, we also call for more field research to determine the impacts of illegal trade on wild populations, an updated assessment of its conservation status, increased cooperation between national enforcement agencies, and the implementation of targeted human behaviour change initiatives to help reduce consumer demand for this species.

Using in vitro/in silico data for consumer safety assessment of feed flavoring additives – A feasibility study using piperine

Consumer health risk assessment for feed additives is based on the estimated human exposure to the additive that may occur in livestock edible tissues compared to its hazard. We present an approach using alternative methods for consumer health risk assessment. The aim was to use the fewest possible number of animals to estimate its hazard and human exposure without jeopardizing the safety upon use. As an example we selected the feed flavoring substance piperine and applied in silico modeling for residue estimation, results from literature surveys, and Read-Across to assess metabolism in different species. Results were compared to experimental in vitro metabolism data in rat and chicken, and to quantitative analysis of residues' levels from the in vivo situation in livestock. In silico residue modeling showed to be a worst case: the modeled residual levels were considerably higher than the measured residual levels. The in vitro evaluation of livestock versus rodent metabolism revealed no major differences in metabolism between the species. We successfully performed a consumer health risk assessment without performing additional animal experiments. As shown, the use and combination of different alternative methods supports animal welfare consideration and provides future perspective to reducing the number of animals.

Short Time Exposure (STE) test in conjunction with Bovine Corneal Opacity and Permeability (BCOP) assay including histopathology to evaluate correspondence with the Globally Harmonized System (GHS) eye irritation classification of textile dyes

Eye irritation evaluation is mandatory for predicting health risks in consumers exposed to textile dyes. The two dyes, Reactive Orange 16 (RO16) and Reactive Green 19 (RG19) are classified as Category 2A (irritating to eyes) based on the UN Globally Harmonized System for classification (UN GHS), according to the Draize test. On the other hand, animal welfare considerations and the enforcement of a new regulation in the EU are drawing much attention in reducing or replacing animal experiments with alternative methods. This study evaluated the eye irritation of the two dyes RO16 and RG19 by combining the Short Time Exposure (STE) and the Bovine Corneal Opacity and Permeability (BCOP) assays and then comparing them with in vivo data from the GHS classification. The STE test (first level screening) categorized both dyes as GHS Category 1 (severe irritant). In the BCOP, dye RG19 was also classified as GHS Category 1 while dye RO16 was classified as GHS no prediction can be made. Both dyes caused damage to the corneal tissue as confirmed by histopathological analysis. Our findings demonstrated that the STE test did not contribute to arriving at a better conclusion about the eye irritation potential of the dyes when used in conjunction with the BCOP test. Adding the histopathology to the BCOP test could be an appropriate tool for a more meaningful prediction of the eye irritation potential of dyes.