The fourth EC report on the statistics of laboratory animal use: trends, recommendations and future prospects

At the beginning of 2005, the European Commission published its fourth report on the statistics of the number of animals used for experimental and other scientific purposes. A total of 10.7 million animals were used within the Member States of the European Union (EU) in 2002, an increase of almost a million animals since the 1999 report. France, Germany and the UK continue to be the largest users of animals for scientific purposes, and mice, rats, fish and birds remain the most commonly-used animals. For the first time, all 15 Member States used the standardised EU tables, as had been agreed in 1998. This has made it easier to identify areas on which Three Rs initiatives should be focused. Nevertheless, the reporting system still has a number of serious deficiencies. In particular, there are insufficient data on the numbers of animals that are kept or bred for research purposes, the numbers of transgenic animals, and the severity of procedures that are applied.     

The Target Animal Safety Test—Is it Still Relevant?

In Europe, the target animal safety test (TAST) is stipulated by 52 European Pharmacopoeia monographs, by three European Union (EU) Directives and a number of EU guidelines as a routine test for veterinary immunologicals, to be carried out on the finished product. TAST data from seven European Official Member States Control Laboratories (OMCLs) and 14 manufacturers were retrospectively analysed. During 1994–1997, 11 185 vaccine batches had been submitted for batch release, and the OMCLs had tested 670 batches in the TAST (665 passed, 4 passed after retesting, 1 failed). In total, 82 of these batches were not released; however, in only one case this was due to failure in the TAST. The data received from the 14 manufacturers covered the years from 1997 to 1999. 11 386 batches were tested in the TAST, of which 215 passed after retesting and 7 failed. Although only 30% of the OMCLs provided data and the data of the manufacturers are not complete they clearly indicate that the TAST does not contribute to the safety of veterinary vaccines and should therefore not be required as a routine batch test. In cases, where it appears to be necessary, detailed guidance on the test design and evaluation should be given. Copyright 2002 Published by Elsevier Science Ltd on behalf of The International Association for Biologicals.     

Comments on the sub-group reports of the EU Technical Expert Working Group on the revision of Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes

A critical analysis is presented of the reports produced by four Technical Expert Working Group Sub-groups (SGs) on Ethical Review, Cost-Benefit, Authorisation and Scope, which were published on the EC website (http://ec.europa.eu/environment/chemicals/lab_animals/ia_info_en.htm), as part of the European Commission (EC)s review of EU Directive 86/609 EEC. This is in addition to our official response to the internet consultation questionnaire, submitted to the Commission on behalf of FRAME. Whilst the respective SG reports were extensive and detailed, we have identified several shortcomings, and in particular, a frequent lack of consensus among the SG members, resulting in a lack of clear guidance for the EC on what the revised Directive should contain, with reference to a number of crucial issues. Such indecisiveness could lead to wide discrepancies in the approaches of the EC, the European Parliament and the EU Member States concerning many issues of importance to animal welfare and the implementation of alternatives to animal experiments. These concerns range from logistical issues, such as requirements for named officers in authorised establishments, and the recording and publishing of statistics on animal use, to ethical and scientific problems, including the use of non-human primates, local ethical review, and education and training on the essential link between the Three Rs concept and best scientific practice. In each case, the basis for our concerns is explained, and suggestions for improvements to be incorporated into the revised Directive are made, in the hope that the harmonisation of approaches to laboratory animal experimentation and the use of alternative methods in the Member States can be maximised.     

An assessment of the hospital exemption landscape across European Member States: regulatory frameworks,use and impact

The hospital exemption (HE) (Article 28(2) of Regulation (EC) No 1394/2007; the “ATMP Regulation”) rule allows the invaluable opportunity to provide patients with access to innovative, potentially life-saving treatments in situations of unmet clinical need. Unlicensed, developmental advanced therapy medicinal products (ATMPs) - cell-, gene- or tissue-based therapies - can be used to treat patients under certain conditions. Such products should be produced on a non-routine basis, custom-made for an individual patient under the responsibility of the requesting physician, for use in a hospital setting within the same Member State in which they are manufactured. The HE rule, and the specific requirements permitting its use, is further regulated at the Member State level, which has led to divergence in the implementation of HE across the European Union (EU). As a result, HE use varies significantly across Member States depending on their respective national legal implementation, policy makers’ interpretation of HE, clarity of guidance at the national level, reimbursement opportunities and level of ATMP research and development activities carried out by academic and commercial organizations. With important variations in how quality, safety and efficacy standards are implemented and controlled across EU Member States for ATMPs provided via the HE rule and a lack of transparency around its use, the HE rule draws concern around its potential impact on public health. In this article, the authors report results of a legal analysis of the implementation of HE across the UK, France, Germany, Italy, Spain, Poland and the Netherlands and research findings on its current utilization, highlighting divergences across countries as well as gaps in legislation and control in these countries. The significance of these divergences and the differing levels of enforcement are discussed as well as their associated impact on patients, industry and health care professionals.     

How do 28 European Union Member States perform in agricultural greenhouse gas emissions? It depends on what we look at: Application of the multi-criteria analysis

European Union (EU) Member States have agreed to limit their greenhouse gas (GHG) emissions from sectors not covered by the EU Emissions Trading Scheme, including emissions from agricultural sector. The aggregated GHG emission rate (i.e. t CO₂ eq. from agricultural sector per country) is commonly used to measure the overall size of agriculture’s influence on climate. And indeed, since 2005, EU has managed to decrease its aggregated GHG emissions by 3.1%. However, the question is—does that mean that EU’s agriculture has become less emission intensive? This paper answers the question by providing a different perspective for the assessment and comparison of the agricultural GHG emissions in 28 EU Member States. It is done by applying three different approaches, including creation of derived indicators and application of multi-criteria analysis (TOPSIS), which is a novel approach for comparison of agricultural GHG emission mitigation performance. The results show that each EU Member State performs very differently in emission intensities. Even more, the emission intensity results show an alarming tendency of increase in most of the EU Member States, which indicates that the measured changes in aggregate agricultural GHG emission rates are misleading. Therefore, the paper suggests reconsidering the policy targets for GHG emission limits.     

Hormones in meat: different approaches in the EU and in the USA

The use of hormonal active growth promoters ("hormones") in farm animals can increase the production of veal and beef significantly up to 15%. However, in the different parts of the world the regulation regarding the use of such hormones differs sharply. In the European Union there exists a total ban on such use in contrast to the United States of American where the use of some hormones is authorized under strict conditions. An overview is given of the different opposing aspects and their consequences are discussed. It has to be concluded that in some EU Member States an extended black market exists. For the USA no experimental evidence is available for such a black market. In the EU the number of ascertained different illegal "hormones" ranges between about 35 and 55. In the USA the number of legal hormones in total is six. The levels of hormone residues found in beef originating from the USA are in the fast majority of cases below the Maximum Residue Limit as recommended by the FAO/WHO Joint Expert Committee of Food Additives. No comparable experimental data are available for the EU. Finally other food commodities have to be taken into account to assess potential risks of the dietary intake of "hormones". Eggs, example given, contribute more to the dietary intake of estradiol than beef, whether the animal is legally treated with hormones or not.     

The latest statistics of scientific procedures on living animals reveal little three rs progress in great britain in 2010

The 2010 Statistics of Scientific Procedures on Living Animals showed that the level of animal experimentation in Great Britain continues to rise, with just over 3.7 million procedures being conducted. This is almost exclusively due to the sustained increase in the breeding and utilisation of genetically-altered animals. Here, the general trends in the species used and the numbers and types of procedures are reviewed. In addition, the impact of the recent Government announcement to ban testing of household products on animals is discussed, along with the implications of the fish becoming the second most frequently used animal in scientific research. Finally, concerns about primate use, the REACH System, cosmetics testing and the new EU Directive on the protection of laboratory animals are explained.     

EFSA’s scientific activities and achievements on the risk assessment of genetically modified organisms (GMOs) during its first decade of existence: looking back and ahead

Genetically modified organisms (GMOs) and derived food and feed products are subject to a risk analysis and regulatory approval before they can enter the market in the European Union (EU). In this risk analysis process, the role of the European Food Safety Authority (EFSA), which was created in 2002 in response to multiple food crises, is to independently assess and provide scientific advice to risk managers on any possible risks that the use of GMOs may pose to human and animal health and the environment. EFSA’s scientific advice is elaborated by its GMO Panel with the scientific support of several working groups and EFSA’s GMO Unit. This review presents EFSA’s scientific activities and highlights its achievements on the risk assessment of GMOs for the first 10 years of its existence. Since 2002, EFSA has issued 69 scientific opinions on genetically modified (GM) plant market registration applications, of which 62 for import and processing for food and feed uses, six for cultivation and one for the use of pollen (as or in food), and 19 scientific opinions on applications for marketing products made with GM microorganisms. Several guidelines for the risk assessment of GM plants, GM microorganisms and GM animals, as well as on specific issues such as post-market environmental monitoring (PMEM) were elaborated. EFSA also provided scientific advice upon request of the European Commission on safeguard clause and emergency measures invoked by EU Member States, annual PMEM reports, the potential risks of new biotechnology-based plant breeding techniques, evaluations of previously assessed GMOs in the light of new scientific publications, and the use of antibiotic resistance marker genes in GM plants. Future challenges relevant to the risk assessment of GMOs are discussed. EFSA’s risk assessments of GMO applications ensure that data are analysed and presented in a way that facilitates scientifically sound decisions that protect human and animal health and the environment.     

European experimental animal use declines ever so slightly

The latest report on experimental animal use in the EU indicates a slight decrease. However, the figures, which are for 2008, show that around 12 million animals are still used in laboratories throughout Europe. To date, only a summary of the data has been published, and so this report is limited to giving a comparison of trends and significant changes. The impact on the figures of the revision of Directive 86/609/EEC and the 7th Amendment to the Cosmetics Directive 76/768/EEC is discussed. In addition, consideration is given to which areas of research and regulation will need to be closely monitored, and the importance of continuing to push for the implementation of Three Rs initiatives is highlighted.     

Genital Chlamydia Prevalence in Europe and Non-European High Income Countries: Systematic Review and Meta-Analysis

Background

Accurate information about the prevalence of Chlamydia trachomatis is needed to assess national prevention and control measures.

Methods

We systematically reviewed population-based cross-sectional studies that estimated chlamydia prevalence in European Union/European Economic Area (EU/EEA) Member States and non-European high income countries from January 1990 to August 2012. We examined results in forest plots, explored heterogeneity using the I² statistic, and conducted random effects meta-analysis if appropriate. Meta-regression was used to examine the relationship between study characteristics and chlamydia prevalence estimates.

Results

We included 25 population-based studies from 11 EU/EEA countries and 14 studies from five other high income countries. Four EU/EEA Member States reported on nationally representative surveys of sexually experienced adults aged 18–26 years (response rates 52–71%). In women, chlamydia point prevalence estimates ranged from 3.0–5.3%; the pooled average of these estimates was 3.6% (95% CI 2.4, 4.8, I² 0%). In men, estimates ranged from 2.4–7.3% (pooled average 3.5%; 95% CI 1.9, 5.2, I² 27%). Estimates in EU/EEA Member States were statistically consistent with those in other high income countries (I² 0% for women, 6% for men). There was statistical evidence of an association between survey response rate and estimated chlamydia prevalence; estimates were higher in surveys with lower response rates, (p = 0.003 in women, 0.018 in men).

Conclusions

Population-based surveys that estimate chlamydia prevalence are at risk of participation bias owing to low response rates. Estimates obtained in nationally representative samples of the general population of EU/EEA Member States are similar to estimates from other high income countries.     

State of the art in artificial insemination of pigs in the United States.

Currently, the United States ranks second in pork production worldwide. In 1999 the breeding herd consisted of approximately 6.2 million breeding females with an annual production of 100 million market animals having an average market live weight of 118.6 kg. The objective of this paper is to briefly describe the current US swine artificial insemination (AI) industry and to profile semen production and insemination practices that are currently in use.     

Birth and death rate estimates of cats and dogs in U.S. households and related factors

Studies report variable factors associated with dog and cat surpluses in the United States. Estimates of cat and dog birth and death rates help understand the problem. This study collected data through a commercial survey company, distributing questionnaires to 7,399 cat- and dog-owning households (HHs) in 1996. The study used an unequal probability sampling plan and reported estimates of means and variances as weighted averages. The study used estimates of HHs and companion animals for national projections. More than 9 million owned cats and dogs died during 1996-yielding crude death rates of 8.3 cat deaths/100 cats in HHs and 7.9 dog deaths/100 dogs in HHs. The study reported twice as many kitten as puppy litters, with an average litter size of 5.73 and 7.57, respectively. The study reported data on planned versus unplanned litters, reasons caregivers did not spay females, disposition of litters, and sources of animals added to HHs. These first national estimates indicate the magnitude of, and reasons for, animals leaving HHs. The crude birth rate was estimated to be 11.2 kittens/100 cats in HHs and 11.4 puppies/100 dogs in HHs.     

Birth and Death Rate Estimates of Cats and Dogs in U.S. Households and Related Factors

Studies report variable factors associated with dog and cat surpluses in the United States. Estimates of cat and dog birth and death rates help understand the problem. This study collected data through a commercial survey company, distributing questionnaires to 7,399 cat- and dog-owning households (HHs) in 1996. The study used an unequal probability sampling plan and reported estimates of means and variances as weighted averages. The study used estimates of HHs and companion animals for national projections. More than 9 million owned cats and dogs died during 1996-yielding crude death rates of 8.3 cat deaths/100 cats in HHs and 7.9 dog deaths/100 dogs in HHs. The study reported twice as many kitten as puppy litters, with an average litter size of 5.73 and 7.57, respectively. The study reported data on planned versus unplanned litters, reasons caregivers did not spay females, disposition of litters, and sources of animals added to HHs. These first national estimates indicate the magnitude of, and reasons for, animals leaving HHs. The crude birth rate was estimated to be 11.2 kittens/100 cats in HHs and 11.4 puppies/100 dogs in HHs.     

Development of a nature value index for pastoral farmland—A rapid farm-level assessment

Sustainable agriculture is important for the safeguarding of natural resources (e.g. semi-natural habitats, clean water and energy), food production and for the survival of rural communities. As part of the EU strategy towards sustainability Member States are committed to identifying and protecting areas of agrobiodiversity. Identification of the extent and support of High Nature Value (HNV) farmland across the EU was an important policy requirement of Member States Rural Development Programmes (RDP) (2007–2013) but problems defining the extent of HNV farmland have delayed progress to date. Following a five step statistical process, we developed a simple 10 point nature value index based on percentage improved agricultural grassland, stocking density (LU/ha Utilisable Agricultural Area) and length of linear habitats per hectare on a farm. We propose an index that can be used to highlight farms with low biodiversity allowing targeting of sustainability measures such as increasing field boundary area or reducing inorganic Nitrogen inputs, farms that are already sustainable from a biodiversity perspective, and could be labelled as such through national programs or even farms that are High Nature Value (HNV) and should be targeted through results-based agri-environment schemes. This nature value index has potential to be applied to a range of farmed pastoral landscapes in North West Europe's Atlantic biogeographic region. The methodology used in the development of the index has the potential to be used in other biogeographic zones to develop similar indices of nature value at farm level. This index is a simple to use, easily accessible identification tool based on farm-level data which can be utilised in sustainability indices and HNV farmland identification.     

Costs and benefits of freedom from shrimp diseases in the European Union

The growth in penaeid shrimp aquaculture has been mirrored by the emergence of a number of serious diseases, some of which (e.g. white spot syndrome virus - WSSV) spread rapidly across the globe through movement of infected stock. The World Organisation for Animal Health (OIE) lists six penaeid shrimp pathogens of which three are notifiable in the EU: WSSV (listed as non-exotic to the EU), Taura syndrome virus (TSV) and yellow head disease (YHD) (both listed as exotic). EU Member States (MS) must determine a status for non-exotic diseases (e.g. disease free, unknown, infected). In developing a policy for WSSV, import risk analysis (IRA) can be used to systematically assess the risks of introduction and justify risk mitigation to maintain freedom. OIE guidelines recommend that countries assess the risk of disease introduction via commodities, not listed by the OIE as safe, and apply sanitary measures if necessary. The sanitary measures necessary to maintain freedom from WSSV may not be compatible with current EU animal health legislation. The recent revision by OIE of products listed as safe for international trade strengthens the case for the risks of TSV and YHD introduction into the EU to be assessed. Freedom from WSSV is an important criterion for the development of shrimp aquaculture in the EU. However, in developing disease control policy, governments need to balance the potentially competing interests of all stakeholders, including consumers. Thus economic modelling of the impact of possible sanitary measures on consumer prices of imported products is needed to support decision making. The creation of disease free compartments and post-import risk mitigation for commodities may create the conditions conducive to the development of shrimp aquaculture whilst minimising the costs of maintaining disease freedom.     

No Dog Left Behind: A Hedonic Pricing Model for Animal Shelters

Companion animal overpopulation is a growing problem in the United States. In addition to strays, an average of 324,500 nonhuman animals are relinquished to shelters yearly by their caregivers due to family disruption (divorce, death), foreclosure, economic problems, or minor behavioral issues. As a result, estimates of animals in shelters range from 3 million to 8 million, and due to overcrowding, euthanasia is common. This analysis seeks to determine the appropriate pricing mechanisms to clear animal shelters of dogs in the manner most desirable—that is, through adoption. Based on a survey of Michigan residents, it is clear there are a number of correlations between the traits of dogs and the individuals who care for them. Hedonic pricing models indicate that animal shelters need to proactively vary their pricing systems to discount particular traits, specifically for mixed-breed, older, and black dogs. Premiums can be charged for puppies, purebred dogs, and those who have received specific services such as microchipping.     

Economic Impact of a triptan Rx-To-OTC Switch in Six EU Countries

Introduction

Triptans have been safely and effectively used in the management of migraine for more than fifteen years, and it seems reasonable to wonder what would be the economic impact of moving a specific triptan to OTC availability. The objective of this study was then to examine the economic impact of payer policies of a triptan Rx-to-OTC switch in six EU countries (France, UK, Spain, Italy, Germany and Poland).

Methods

A decision model was used to model the budgetary impact of a triptan Rx-to-OTC switch from the third-party payer (TPP) and the societal perspectives, using a one-year timeframe.

Results

From the TPP perspective, it is estimated that the current overall direct spending on the management of migraine attacks across the 6 EU Member States is €582 million annually, and that the savings would reach €75 million (13% of the overall direct economic burden of migraine). From the societal perspective, €86 million annually would be added.

Conclusions

Given evidence of effectiveness and safety, and given the potential savings, a triptan Rx-to-OTC switch is a reasonable public policy decision.     

Big-game,small-game,and gamebird hunting in New Zealand: Hunting effort,harvest, and expenditure in 1988

Abstract

A postal survey of 8639 licensed firearm owners in 1989 indicated that an estimated 117 200 ± 6300 New Zealanders (3.5% of the total population) did some hunting in 1988. An estimated 33 100 former hunters did not hunt in 1988 but thought it likely that they would hunt again in future. The survey provided useful estimates of 1988 national totals for hunting effort (4.4 million hunter days), gross expenditure ($NZ100 million), and harvest (6.5 million animals).

Small-game hunting dominated, involving 81% of hunters, 59% of total hunting effort, and 86% of total numerical harvest: rabbits (Oryctolagus cuniculus) and possums (Trichosurus vulpecula) each comprised 40% of the national bag. Gamebird hunting involved 48% of hunters, 19% of effort, and 11% of total harvest: ducks comprised 73% of the gamebird harvest. Although big-game hunting attracted the fewest hunters (42%) it ranked second for hunting effort (21%). Big game formed 3% of the total numerical harvest: pigs (Sus scrofa), goats (Capra hircus), and red deer (Cervus elaphus scoticus) were the most commonly taken. Big-game were estimated to comprise 49% of total harvest biomass, followed by small-game (47%), and gamebirds (4%). Most deer (nearly 60%) were taken for recreation, with helicopter-based hunting accounting for only one-third the total deer harvest.

A quarter of those people hunting in 1988 hunted on five or fewer days that year, and a relatively small group of mainly professional hunters accounted for a disproportionately large share of the overall harvest Hunters reported spending an average of $851 each on hunting in 1988. Expenditure on big-game comprised 44% of the total, small-game 23%, and gamebirds 33%. Expenditure per animal harvested or per day hunted was greater for big-game animals (other than goats) than for gamebirds, which were more expensive to hunt than small-game. Total hunting effort was inversely related to the average expenditure per animal harvested, regardless of the type of game.     

Steady-state balance model to calculate the indoor climate of livestock buildings, demonstrated for finishing pigs

The indoor climate of livestock buildings is of importance for the well-being and health of animals and their production performance (daily weight gain, milk yield etc). By using a steady-state model for the sensible and latent heat fluxes and the CO₂ and odour mass flows, the indoor climate of mechanically ventilated livestock buildings can be calculated. These equations depend on the livestock (number of animals and how they are kept), the insulation of the building and the characteristics of the ventilation system (ventilation rate). Since the model can only be applied to animal houses where the ventilation systems are mechanically controlled (this is the case for a majority of finishing pig units), the calculations were done for an example of a finishing pig unit with 1000 animal places. The model presented used 30 min values of the outdoor parameters temperature and humidity, collected over a 2-year period, as input. The projected environment inside the livestock building was compared with recommended values. The duration of condensation on the inside surfaces was also calculated. Received: 8 March 1999 / Revised: 1 November 1999 / Accepted: 4 November 1999