浅论实验动物兽医的职责及实践

随着我国实验动物科学和动物试验的迅速发展,实验动物兽医的需求越来越大。实验动物兽医的角色多种多样,广义地讲可以是任何具有兽医资质且从事实验动物管理、繁育、疾病诊断防治、动物试验和研究的人员。通常实验动物兽医是指实验动物临床兽医或实验动物主管兽医。实验动物兽医的天职是确保动物的健康和福利,并支持高质量的动物试验研究。本文从实验动物兽医工作的必要性、实验动物兽医的发展、实验动物兽医的资质、职责等几个方面,并结合合同外包研发机构中兽医的实践阐述了实验动物兽医的工作性质、任务和内容。     

Guidelines for the veterinary care of laboratory animals: report of the FELASA/ECLAM/ESLAV Joint Working Group on Veterinary Care

Veterinary professionals working in partnership with other competent persons are essential for a successful animal care and use programme. A veterinarian's primary responsibilities are defined by their own professional regulatory bodies, but in this area of work there are further opportunities for contribution, which will assist in safeguarding the health and welfare of animals used in research. These guidelines are aimed not only at veterinarians to explain their duties, and outline the opportunities to improve the health and welfare of animals under their care, but also at employers and regulators to help them meet their responsibilities. They describe the desirability for postgraduate education towards specialization in laboratory animal medicine and detail the many competencies necessary to fulfil the role of the laboratory animal veterinarian. They detail the need for veterinary expertise to promote good health and good welfare of animals used in biomedical research during husbandry as well as when under experimental procedures. Regulatory and ethical aspects are covered as are the involvement of the veterinarian in education and training of others working in the animal care and use programme. Managerial aspects, including occupational health and safety, are also areas where the veterinarian's input can assist in the successful implementation of the programme.     

In pursuit of peak animal welfare; the need to prioritize the meaningful over the measurable

Despite the diversity of animal welfare definitions, most recognise the centrality of the feelings of animals which are currently impossible to measure directly. As a result, animal welfare assessment is heavily reliant upon the indirect measurement of factors that either affect what animals feel, or are effected by how they feel. Physiological and health orientated measures have emerged as popular metrics for assessing welfare because they are quantifiable, can effect and be affected by how animals feel and have merits regardless of their relationship to the feelings of animals. However, their popularity in animal welfare assessment has led to them having a disproportionate influence on animal management to the detriment of animal welfare in numerous instances. Here, the case is made that a tension exists between management that prioritizes aspects of care reflecting popular animal welfare metrics such as those relating to physical health, and management that emphasizes psychological wellbeing. By re‐examining the relative merits of physical and psychological priorities in animal management, an alternate animal welfare paradigm emerges less tied to traditional welfare metrics. This paradigm theorizes about the possibility for an optimal animal welfare state to exist where managed animal populations provided essential psychological outlets but protected from key physical stressors routinely experienced in the wild, might experience higher levels of welfare than wild populations would routinely experience. The proposition that optimal animal welfare could theoretically be achieved in well managed and well designed captive environments challenges a widely held ethical perspective that captivity is inherently bad for animal welfare.     

Behaviour as a tool in the assessment of animal welfare

A central issue in animal welfare research is how to assess the welfare state of animals objectively and scientifically. I argue that this issue can be approached by asking two key questions: 1) is the animal physically healthy and 2) does the animal have what it wants? Behaviour is used to answer both of these questions. In the assessment of physical health, it can be used for clinical and pre-clinical diagnosis. In the assessment of what animals want, it has a major role through choice and preference testing. It is particularly important that applied ethologists develop methods for assessing welfare in situ--in the places where concern for animal welfare is greatest such as on farms and in zoos.     

Eating nanomaterials: cruelty-free and safe? the EFSA guidance on risk assessment of nanomaterials in food and feed

Nanomaterials are increasingly being added to food handling and packaging materials, or directly, to human food and animal feed. To ensure the safety of such engineered nanomaterials (ENMs), in May 2011, the European Food Safety Authority (EFSA) published a guidance document on Risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain. It states that risk assessment should be performed by following a step-wise procedure. Whenever human or animal exposure to nanomaterials is expected, the general hazard characterisation scheme requests information from in vitro genotoxicity, toxicokinetic and repeated dose 90-day oral toxicity studies in rodents. Numerous prevailing uncertainties with regard to nanomaterial characterisation and their hazard and risk assessment are addressed in the guidance document. This article discusses the impact of these knowledge gaps on meeting the goal of ensuring human safety. The EFSA's guidance on the risk assessment of ENMs in food and animal feed is taken as an example for discussion, from the point of view of animal welfare, on what level of uncertainty should be considered acceptable for human safety assessment of products with non-medical applications, and whether animal testing should be considered ethically acceptable for such products.     

Avoiding an overzealous approach: a perspective on regulatory burden

The authors discuss the impact of regulatory burden on the research enterprise, with emphasis on animal care and use programs. They identify three sources of regulatory burden: specific requirements in law and regulation, interpretive requirements or "guidance" by regulatory agencies, and self-imposed regulatory burden resulting from institutional interpretations. Attempting to minimize the risks of noncompliance through the overzealous application of "requirements" does not necessarily benefit the animals. Balancing risks associated with animal research and burden in a successful program requires clear and consistent communication among all stakeholders--the institutional leadership, institutional animal care and use committee (IACUC), attending veterinarian and staff, and scientists. An evaluation tool is provided for institutions to assess their approach to required and voluntary activities in their animal care program. Drawing on the knowledge and experience gained in a combined 40 years of serving on, managing, training, and evaluating animal care programs, the authors conclude that institutions must thoughtfully balance their research and compliance needs to successfully maintain their institutional goals. They stress that a culture of compliance based on knowledge of the regulations, dedication to quality animal care, reasoned use of science-based performance standards, and the judicious application of professional judgment is the foundation for facilitation of research in the context of animal welfare and regulatory compliance.     

GLP原则在体外毒理学评价实验室的应用

在动物福利运动的推动下,以减少、优化和替代动物试验为核心内容的体外试验系统已成为安全评价不可或缺的组成部分,在药品、化学品、化妆品毒理学评价中起到重要作用。体外试验系统不同于体内动物实验,体外毒理学实验室GLP原则的建立和运行应充分考虑体外试验系统的特殊性。目前我国专业的体外安全评价实验室的建设刚刚起步,还没有可供借鉴的成熟经验。本文从实验室组织、试验系统维护、人员职责、质量管理和运行几个方面,介绍了GLP原则在化妆品体外毒理学检验和评价实验室的应用。     

The Concept of Animal Welfare at the Interface between Producers and Scientists: The Example of Organic Pig Farming

In organic farming animal welfare is one important aspect included in the internationally agreed organic principles of health, ecology, fairness and care (IFOAM 2006), reflecting expectation of consumers and farmers. The definition of organic animal welfare includes—besides traditional terms of animal welfare—‘regeneration’ and ‘naturalness’. Organic animal welfare assessment needs to reflect this and use complex parameters, include natural behaviour and a systemic view. Furthermore, various parties with seemingly conflicting interests are involved, causing ethical dilemmas, such as the use of nose rings for outdoor sows (impaired animal welfare vs. destruction of humus). Solutions can only be found when foundational concepts are translated and applied to practical situations. On-farm animal welfare assessment and implementation of improvement strategies are increasingly relevant scientific areas. They combine on-farm welfare assessment, identification of key problem areas and connected risk factors. Constant communication between all parties is crucial for success. Animal health and welfare planning is one application of this approach, which was carried out on Austrian organic pig farms as well as organic dairy farms in seven European countries. The projects included welfare assessment, feedback and benchmarking as a tool for communication between farmers, advisors and scientists. Finally goals were set by the farmer and improvement strategies applicable to organic farming were implemented. This included prevention of disease by management strategies instead of routine treatment with pharmaceutical products. It appeared that next to problem structuring, multidisciplinary problem solving demands good communications skills to relate animal welfare science to value reflections.     

Assessing the welfare impact of foot disorders in dairy cattle by a modeling approach

Foot disorders are the main cause of dairy cow lameness and are considered to have a major impact on the welfare of dairy cattle. This study adopts a modeling approach, using a dynamic stochastic model, to provide more insight into the welfare impact of different types of foot disorders, both clinical and subclinical. The impact of specific foot disorders on welfare was assessed by simulating the incidence and duration of foot disorders and the pain associated with them. Pain assessment was based on locomotion scores, with underlying knowledge obtained from scientific literature and experts. The results demonstrated the seriousness of the welfare impact of foot disorders. The negative welfare impact was measured on a scale from 0 to 60, where the maximum outcome represents a cow having very severe pain during the whole year. On average, each cow achieves a welfare impact score of 12, which is 20% of the maximum welfare impact score. This welfare score equals having severe pain for a period of 3 months, indicating a serious impact on welfare. On average, digital dermatitis impacts most on welfare, which is caused by a high incidence of the painful clinical stage, followed by sole hemorrhages (SoH) and interdigital dermatitis and heel horn erosion (IDHE). The combination of a high incidence and long duration of SoH and IDHE causes this relatively high welfare impact of foot disorders that occur mostly subclinically. On average, over 1 year, 46% of the welfare impact due to foot disorders is caused by clinical foot disorders. The fact that subclinical foot disorders contribute more or less equally to the effects on welfare as clinical ones, indicates that farmers may readily underestimate the welfare impact by a factor two. Modeling welfare impact at cow level, individual cases of foot disorders, stresses the importance of pain intensity, indicating the importance of clinical foot disorders. This study demonstrated the serious welfare impact of foot disorders in dairy cattle and pointed out the considerable impact of subclinical foot disorders. Furthermore, the approach of welfare assessment, for example herd v. cow level, influenced the ranking of foot disorders for their impact on animal welfare. Potentially, this leads to different prioritization of specific solution strategies for dairy farmers, for example, focusing on cow comfort, hygiene or preventive medical treatments, foot trimming and/or health monitoring. The findings in this study support in raising awareness about this welfare issue.     

Effects of a participatory approach,with systematic impact matrix analysis in herd health planning in organic dairy cattle herds

The animal health and welfare status in European organic dairy production does not in all aspects meet the organic principles and consumers’ expectations and needs to be improved. To achieve this, tailored herd health planning, targeted to the specific situation of individual farms could be of use. The aim of this study was to apply herd health planning in a structured participatory approach, with impact matrix analysis, not previously used in this context, in European organic dairy farms and to assess changes in animal health and welfare. Herd health planning farm visits were conducted on 122 organic dairy farms in France, Germany and Sweden. The farmer, the herd veterinarian and/or an advisor took part in the farm discussions. The researcher served as facilitator. Baseline data on the animal health status of the individual farm, collected from national milk recording schemes, were presented as an input for the discussion. Thereafter a systematic impact matrix analysis was performed. This was to capture the complexity of individual farms with the aim to identify the farm-specific factors that could have a strong impact on animal health. The participants (i.e. farmer, veterinarian and advisor) jointly identified areas in need of improvement, taking the health status and the interconnected farm system components into account, and appropriate actions were jointly identified. The researcher took minutes during the discussions, and these were shared with the participants. No intervention was made by the researcher, and further actions were left with the participants. The number of actions per farm ranged from 0 to 22. The change in mortality, metabolic diseases, reproductive performance and udder health was assessed at two time points, and potential determinators of the change were evaluated with linear regression models. A significant association was seen between change in udder health, as measured by the somatic cell count, and country. At the first follow-up, a significant association was also found between change in the proportion of prolonged calving interval and the farmers’ desire to improve reproductive health as well as with an increase in herd size, but this was not seen at the second follow-up. The degree of implementation of the actions was good (median 67%, lower quartile 40%, upper quartile 83%). To conclude, the degree of implementation was quite high, improvement of animal health could not be linked to the herd health planning approach. However, the approach was highly appreciated by the participants and deserves further study.     

Juvenile animal studies and pediatric drug development retrospective review: use in regulatory decisions and labeling

Juvenile animal toxicity studies are conducted to support applications for drugs intended for use in children. They are designed to address specific questions of potential toxicity in the growing animal or provide data about long-term safety effects of drugs that cannot be obtained from clinical trials. Decisions to conduct a juvenile animal study are based on existing data, such as a safety signal already identified in adult studies, or previous knowledge of the drug or chemical class for its potential to impair growth or developmental milestones. In 2006, the FDA issued an industry guidance in which considerations for determining when a juvenile animal study is warranted were outlined. A retrospective study was conducted covering years both before and after the issued guideline to examine the contribution of juvenile animal toxicity studies to the risk/benefit assessment of pediatric drugs at the FDA. The initial findings were presented as part of the May 2010 HESI workshop on the value of juvenile animal studies. The objective of the review was to better understand the value that the juvenile animal study contributes to regulatory decision making for pediatric drug development by looking at when the studies have been included in the product assessment; what, if any, impact the studies had on the regulatory decisions made; and whether the data were incorporated into the label. The data described below represent a first look at impact of the juvenile animal study since the pediatric legislation and the juvenile animal guidance were issued in the US.     

The Take Care program and responsible use of antibiotics

While the contribution of antimicrobial use in pork production to resistant bacteria in human health is uncertain, pork producers have the responsibility to deliver safe and wholesome pork to consumers. The development of a comprehensive producer education and awareness program focused on the responsible use of antimicrobials in pork production is described. The Take Care - Use Antibiotics Responsibly program is based on principles and guidelines that provide the producer and veterinarian the basis for antibiotic use decision-making. The goal of the program is to protect public health while preserving animal health and welfare.     

Validation of a multi-criteria evaluation model for animal welfare

The aim of this paper was to validate an alternative multi-criteria evaluation system to assess animal welfare on farms based on the Welfare Quality® (WQ) project, using an example of welfare assessment of growing pigs. This alternative methodology aimed to be more transparent for stakeholders and more flexible than the methodology proposed by WQ. The WQ assessment protocol for growing pigs was implemented to collect data in different farms in Schleswig-Holstein, Germany. In total, 44 observations were carried out. The aggregation system proposed in the WQ protocol follows a three-step aggregation process. Measures are aggregated into criteria, criteria into principles and principles into an overall assessment. This study focussed on the first two steps of the aggregation. Multi-attribute utility theory (MAUT) was used to produce a value of welfare for each criterion and principle. The utility functions and the aggregation function were constructed in two separated steps. The MACBETH (Measuring Attractiveness by a Categorical-Based Evaluation Technique) method was used for utility function determination and the Choquet integral (CI) was used as an aggregation operator. The WQ decision-makers’ preferences were fitted in order to construct the utility functions and to determine the CI parameters. The validation of the MAUT model was divided into two steps, first, the results of the model were compared with the results of the WQ project at criteria and principle level, and second, a sensitivity analysis of our model was carried out to demonstrate the relative importance of welfare measures in the different steps of the multi-criteria aggregation process. Using the MAUT, similar results were obtained to those obtained when applying the WQ protocol aggregation methods, both at criteria and principle level. Thus, this model could be implemented to produce an overall assessment of animal welfare in the context of the WQ protocol for growing pigs. Furthermore, this methodology could also be used as a framework in order to produce an overall assessment of welfare for other livestock species. Two main findings are obtained from the sensitivity analysis, first, a limited number of measures had a strong influence on improving or worsening the level of welfare at criteria level and second, the MAUT model was not very sensitive to an improvement in or a worsening of single welfare measures at principle level. The use of weighted sums and the conversion of disease measures into ordinal scores should be reconsidered.     

Register-based predictors of violations of animal welfare legislation in dairy herds

The assessment of animal welfare can include resource-based or animal-based measures. Official animal welfare inspections in Denmark primarily control compliance with animal welfare legislation based on resource measures (e.g. housing system) and usually do not regard animal response parameters (e.g. clinical and behavioural observations). Herds selected for welfare inspections are sampled by a risk-based strategy based on existing register data. The aim of the present study was to evaluate register data variables as predictors of dairy herds with violations of the animal welfare legislation (VoAWL) defined as occurrence of at least one of the two most frequently violated measures found at recent inspections in Denmark, namely (a) presence of injured animals not separated from the rest of the group and/or (b) animals in a condition warranting euthanasia still being present in the herd. A total of 25 variables were extracted from the Danish Cattle Database and assessed as predictors using a multivariable logistic analysis of a data set including 73 Danish dairy herds, which all had more than 100 cows and cubicle loose-housing systems. Univariable screening was used to identify variables associated with VoAWL at a P-value<0.2 for the inclusion in a multivariable logistic regression analysis. Backward selection procedures identified the following variables for the final model predictive of VoAWL: increasing standard deviation of milk yield for first lactation cows, high bulk tank somatic cell count (⩾250 000 cells/ml) and suspiciously low number of recorded veterinary treatments (⩽25 treatments/100 cow years). The identified predictors may be explained by underlying management factors leading to impaired animal welfare in the herd, such as poor hygiene, feeding and management of dry or calving cows and sick animals. However, further investigations are required for causal inferences to be established.     

Introduction to the EU REACH legislation

FRAME initiatives on the European Union REACH (Registration, Evaluation and Authorisation of Chemicals) system for the safety testing and risk assessment of chemicals, first proposed as a White Paper in 2001, are summarised. These initiatives considered the scientific and animal welfare issues raised by the REACH proposals, and resulted in a number of suggestions for improvement, many of which seem to have been adopted during the current progress of the legislation through the European Council and European Parliament.     

The importance of considering age when quantifying wild animals’ welfare

Wild animals experience different challenges and opportunities as they mature, and this variety of experiences can lead to different levels of welfare characterizing the day-to-day lives of individuals of different ages. At the same time, most wild animals who are born do not survive to adulthood. Individuals who die as juveniles do not simply experience a homogeneous fraction of the lifetimes of older members of their species; rather, their truncated lives may be characterized by very different levels of welfare. Here, I propose the concept of welfare expectancy as a framework for quantifying wild animal welfare at a population level, given individual-level data on average welfare with respect to age. This concept fits conveniently alongside methods of analysis already used in population ecology, such as demographic sensitivity analysis, and is applicable to evaluating the welfare consequences of human interventions and natural pressures that disproportionately affect individuals of different ages. In order to understand better and improve the state of wild animal welfare, more attention should be directed towards young animals and the particular challenges they face.     

Ethics committee recommendations for laboratory animals in private research in France

Complementary to existing legislation, non-public research companies in France have been working together voluntarily within an organization known as Grice (Interprofessional Working Group on Ethics Committees for Laboratory Animals/Groupe de Réflexion Interprofessionnel sur les Comites d'Ethique appliquée à l'animal de laboratoire) with the objective of creating institutional ethics committees in an effort to promote animal welfare and good scientific procedures. Each company's commitment to the creation of these committees has been expressed by signing the Charter. Each ethics committee is composed of at least three members, including one who is not a scientist; a veterinarian is highly desirable. The committee examines all procedures and protocols involving animals and hands down a favourable or unfavourable opinion, or requests improvements, especially concerning animal well-being. Consensual approval of the protocol is an essential requirement before the purchase or allocation of animals. The committee examines every aspect of laboratory animal housing and care, and inspects all temporary or permanent animal housing facilities. Grice will continue its efforts in relation with public research organizations as well as with groups and in other countries whose objectives are in line with its own.     

The Take Care Program and Responsible Use of Antibiotics

While the contribution of antimicrobial use in pork production to resistant bacteria in human health is uncertain, pork producers have the responsibility to deliver safe and wholesome pork to consumers. The development of a comprehensive producer education and awareness program focused on the responsible use of antimicrobials in pork production is described. The Take Care—Use Antibiotics Responsibly^TM program is based on principles and guidelines that provide the producer and veterinarian the basis for antibiotic use decision-making. The goal of the program is to protect public health while preserving animal health and welfare.     

Assessing animal welfare in sow herds using data on meat inspection,medication and mortality

This paper aims to contribute to the development of a cost-effective alternative to expensive on-farm animal-based welfare assessment systems. The objective of the study was to design an animal welfare index based on central database information (DBWI), and to validate it against an animal welfare index based on-farm animal-based measurements (AWI). Data on 63 Danish sow herds with herd-sizes of 80 to 2500 sows and an average herd size of 501 were collected from three central databases containing: Meat inspection data collected at animal level in the abattoir, mortality data at herd level from the rendering plants of DAKA, and medicine records at both herd and animal group level (sow with piglets, weaners or finishers) from the central database Vetstat. Selected measurements taken from these central databases were used to construct the DBWI. The relative welfare impacts of both individual database measurements and the databases overall were assigned in consultation with a panel consisting of 12 experts. The experts were drawn from production advisory activities, animal science and in one case an animal welfare organization. The expert panel weighted each measurement on a scale from 1 (not-important) to 5 (very important). The experts also gave opinions on the relative weightings of measurements for each of the three databases by stating a relative weight of each database in the DBWI. On the basis of this, the aggregated DBWI was normalized. The aggregation of AWI was based on weighted summary of herd prevalence’s of 20 clinical and behavioural measurements originating from a 1 day data collection. AWI did not show linear dependency of DBWI. This suggests that DBWI is not suited to replace an animal welfare index using on-farm animal-based measurements.