This paper describes the overall achievements of the Animal Health and Welfare (AHAW) Panel of EFSA and its support unit since 2003. The AHAW Panel deals with animal health and animal welfare issues, primarily related to food-producing animals, at the human-animal-environment interface. Scientific opinions adopted by the AHAW Panel are comprehensive scientific reviews and risk assessments and provide the scientific grounds for the identification of control options, most of them being reflected in European Union legislation on animal health and welfare. Between 2004 and 2012, the AHAW Panel delivered 47 scientific opinions related to animal health and 38 scientific opinions on animal welfare on a wide variety of issues. The welfare of animals is a matter of much public concern and has an overall impact on the condition of the animals, with consequences for productivity, disease and food safety. A major achievement of the AHAW Panel has been to establish a unique multidisciplinary capacity, combining expertise in addressing animal health and welfare issues. The AHAW Panel has also demonstrated its capacity to respond rapidly to urgent requests, thus becoming a prominent partner of risk managers in response to crises. Over time, the AHAW Panel has become internationally recognised as a leader in risk assessment in the field of animal health and welfare, based on EFSA core values of scientific excellence, independence and transparency. The development of robust methodological frameworks for the assessment of risks related to animal health and welfare is a continuing process for the AHAW Panel. Over the past ten years, EFSA has achieved greater participation from the scientific community, stakeholders and interested parties, and fostered cooperation with relevant organisations in the EU Member States in the area of animal health and welfare. The AHAW Panel has demonstrated that evaluating health and welfare and assessing risk in animal populations serves to protect public health, the environment and the economic benefit we derive from animals. (C) European Food Safety Authority, 2012

The risk posed by the possible use of dead-in-shell chicks for the production of processed petfood was assessed. According to current legislation two processing methods were considered i) treatment to a minimum Fc value of 3; and ii) treatment of at least 90°C throughout the substance of the final product. A list of the possible pathogens potentially present in the material to be treated was compiled and the available literature data was used to assess the ability of the processing methods to inactivate the most resistant pathogens identified. The processing methods were assessed assuming that the heat treatments would be performed in a moist environment. Spores of Clostridium botulinum were identified as the most resistant hazard potentially present in the material to be processed. Circovirus and parvovirus, and Enterococcus faecium were considered respectively as the most resistant viruses and non-sporulating bacterium to heat treatment. Moreover, depending on storage conditions, the generation of bacterial toxins could be possible. Consequently, the processing methods considered were assessed against their ability to inactivate those hazards. The risk related to the use of dead-in-shell chicks, submitted to a conventional heat treatment to a minimum Fc value of 3 in a moist environment, for the production of canned petfood was considered negligible. No indication is given in the current regulation on the processing time and heating method needed for the treatment at 90°C throughout the substance of the final product. A treatment lasting 18 seconds can assure a rapid destruction of the non-sporeforming bacteria identified as hazards. However, this treatment is not able to inactivate other relevant hazards such as bacterial spores, thermoresistant viruses and some toxins. The final risk posed by the agents that may survive this treatment additionally depends on several factors and cannot be considered to be negligible

Following the emergence in 2009 of the new pandemic H1N1 influenza virus, which contained gene segments from pig, bird and human influenza viruses, it was apparent that a better scientific understanding is required of influenza viruses to protect public and animal health. The latest scientific data on biological properties of the virus, transmissibility, host susceptibility and epidemiology has been evaluated in order to identify factors that could be monitored in animals and that would suggest a risk of emergence of a new pandemic influenza strains. Virological studies and animal models have highlighted the importance of individual virus proteins but virulence and transmissibility are polygenic effects and no single genetic marker can be reliably associated with increased pathogenicity or transmissibility. It was concluded that current monitoring of the influenza gene pool in humans has been able to provide an alert for the emergence of new human influenza strains of public health significance. In contrast, there is an incomplete view of the influenza virus strains circulating among pigs and birds at the global level. Interpretation of the origins and pandemic potential of influenza viruses do require knowledge of the influenza gene pools in both pigs and birds, as well as other animal species. It is recommended that there should be long term support for a passive monitoring network in pigs and birds in order to promote greater understanding of the evolution of influenza viruses at the global level. Maximum benefit can only be obtained by applying an integrated approach involving the medical and veterinary networks including development of harmonised tools and approaches, exchange of virus strains and sequence data and enhancing the coordination and dissemination of the findings from the human, swine and avian networks.d

Analysis of the recent pandemic (H1N1) 2009 (pH1N1) virus indicates a probable origin in pigs. However, it was not reported in pigs prior to its detection in humans. Several cases of pH1N1 virus infections in animals have been reported, mainly in pigs but also in other animals including turkeys. Occasionally, pigs have been infected following exposure to pH1N1 infected humans. In pigs, a subclinical course was common and when clinical signs were seen (coughing, fever) they were generally mild. Presently, the clinical impact of pH1N1virus on the EU pig population is considered minimal. In poultry, outbreaks of pH1N1 have been reported only in turkey breeder flocks. So far, there is no evidence that pH1N1 virus is able to spread horizontally among turkeys. Awareness should be raised about the risk of infecting breeder turkeys with pH1N1 virus during artificial insemination. To date, no infection of wild birds with pH1N1 virus has been reported. From an animal health perspective, no specific disease control measures are considered necessary. Vaccines based on the pH1N1 virus appear to induce protection in swine similar to that induced by the existing swine influenza virus (SIV) vaccines. Such vaccines efficiently prevent disease by reducing virus replication in the lungs. However, voluntary vaccination of swine with these vaccines has not halted the circulation of SIV in swine. There is no urgency for vaccination of pigs against pH1N1 virus. Currently, no vaccines against H1 viruses for poultry are available but at present, there is no need to vaccinate poultry against pH1N1 virus. Monitoring of circulating influenza viruses in swine and poultry populations should be instigated to monitor the evolution of the pH1N1 virus including changes in virulence. (C) European Food Safety Authority, 2010

This report is the second of a series of two technical assessments of the role of ticks in transmission of animal diseases and zoonoses in Eurasia. A previous published scientific opinion (EFSA Journal 2010; (8) 8, 1703) focused on two diseases-Crimean-Congo haemorrhagic fever and African swine fever in Eurasia. The aim of this report is to provide an overview of the geographic distribution of tick species which have proven involvement in the transmission of pathogens causing animal diseases and zoonoses in Eurasia. The report provides maps of the region that display the occurrences of ticks and tick-borne pathogens. Systematic literature review of available publications for the last 10 years and other available literature from the experts were used in the retrieval of the geographical reported cases for the presence of ticks and tick borne pathogens. The report includes a description of the factors that influence the dynamics of the relevant tick species and identify possible high-risk areas in the EU for introduction, considering the biological and ecological characteristics of the ticks and their ability to adapt to new areas. Findings from this review have provided evidence of the extent of ticks and tick-borne diseases (TBDs) in geographical ranges and the existing risk areas that should be considered as baseline information to assess potential risk of these diseases. The report indicates the validity of using available literature to support the presence of ticks and TBDs without further predication using weather and other environmental factors associated with the ticks. survival. The report concluded that animal and human movement play more impact on the spread of the ticks and TBDs. Climate changes and flight pattern of migratory birds can influence the presence and spread of the ticks and TBDs, but have not been determined to be responsible for the widespread distribution of ticks.

The risk that African Swine Fever virus (ASFV) remains endemic in the Trans Caucasian Countries (TCC) and the Russian Federation (RF) is moderate, while the risk of its spread in these regions is high. The resulting risk of introduction from these regions into the EU is moderate most likely through food waste. The risk of ASFV remaining endemic in wild boar and the consequent introduction into the EU was considered low in the TCC and moderate in the RF, mainly due to the higher population density in the RF and the connected wild boar populations to the EU from the RF. Within the EU, mainly domestic pigs in the free range (FR) and the limited biosecurity sector (LB) are likely to be exposed to ASFV via swill feeding, with low risk. Once infected, the risk of spread from the LB and FR sectors prior detection is high, mainly due to movement of pigs, people and vehicles and moderate from the High Biosecurity (HB) sector. The risk of endemicity in domestic pigs is considered negligible in HB and low in LB since the implementation of control measures are effective. The risk of endemicity in the FR sector is moderate due to wild boar contact, noncompliance with animal movement ban and difficult access to all individual pigs. The risk of ASFV becoming endemic in the wild boar population in the EU is moderate, in particular in areas with connected wild boar populations. Because of their long life, ticks of the O. erraticus complex can be important in maintaining local foci of ASFV, where pigs are kept under traditional systems. Ticks do not, play an active role in the geographical spread of the virus. Wild boar have never been found infested because they do not rest inside burrows potentially infested by ticks.

This scientific opinion describes the influence of genetic parameters that have affected the welfare of commercial broilers. There is a lack of robust scientific data for Europe on welfare outcome indicators and these should be recorded independently and made publicly available. The major welfare concerns that have a genetic basis and that may interact with management factors to lead to poor welfare include skeletal disorders, contact dermatitis, ascites and sudden death syndrome. Most of these are linked with fast growth rates. There are also numerous interactions between the environment and the genetic traits that can seriously adversely affect welfare in areas such as lighting regimes, litter management, dietary deficiencies and contamination, air quality and temperature. In the risk assessment the probability of exposure to a hazard, and the magnitude of the poor welfare effects (consequences) of that exposure were estimated. The major risk scores were unbalanced body conformation, high stocking density, fast growth rate, low light intensity and wet litter. The top ranking environmental hazards were high stocking density, low light intensity and wet litter. It was recognised by the experts that probabilities vary from region to region, country to country and among different types of farming system. Recommendations include better data collection in Europe, greater selection strategies for improved welfare traits with birds being selected and tested for their subsequent rearing and production environments by the breeders. Finally, a high priority should be given to decreasing the proportion of birds with the higher gait scores, and to include contact dermatitis and other welfare traits in the selection schemes.

Regulation (EC) No 998/2003(2) lays down the rules for the non-commercial movement of pet animals both within the community as well as from third countries into the EU. The Regulation provides that Member States may maintain their national provisions until July 2008. The United Kingdom (UK), Republic of Ireland and Malta have maintained their national rules in regard to prevention of the introduction of ticks into their own countries. The Commission requested EFSA to assess to what extent abandoning such safeguards could be envisaged, taking into account the different epidemiological situations. This Opinion addresses the justification for the current rules to prevent the introduction of ticks into the three Member States, by pet movement, taking into consideration the epidemiological situation in these countries concerning ticks and tick-borne diseases.Ticks are known to transmit serious zoonotic diseases. Ticks are also considered a major burden in livestock production due to their ability to transmit several diseases as well as causing significant irritation to animals that can influence their productivity. Out of the 866 tick species identified, approximately 54 affect pets, and pets also suffer from tick-borne diseases. In addition pets can be a vehicle to transmit ticks to humans and to new environments and countries.This Opinion has summarized the available information on the presence or absence of the identified tick species and their related diseases.There are limited survey data on the geographical tick distribution among Member States including the UK, Ireland and Malta, and the listed countries(3). Some of the available information is either anecdotal or outdated. The existing reports and literature indicate the presence of selected tick species in UK and Ireland. No information on ticks is available from Malta.Several Tick-Borne Diseases (TBD) have been reported in Member States including the UK, Malta and Republic of Ireland and listed countries. However the frequency of reporting varies between countries both in time period and geographical location. Well-designed targeted surveys are needed in order to determine the absence or presence of ticks, and to increase the epidemiological knowledge for most of the tick-transmitted diseases in the MS.The risk assessment for tick introduction cannot be conducted due to a lack of sufficient data and systematic survey information. It was, therefore, concluded that further assessment of the situation in terms of the value of treatment for the prevention of tick infestation could not be performed. Evaluation of the effectiveness of treatment to prevent infestation by ticks requires prior knowledge about the distribution of ticks in these countries and at a subsequent timepoint. As indicated above, this type of prior knowledge has wide range of uncertainty due to a lack or limited data and records. The issue of the effectiveness of treatment, therefore, was not addressed in this Opinion.The Opinion has clearly indicated a lack of sufficient evidence over the epidemiological situation in the UK Ireland and Malta to refute or accept the justification for the additional measures currently applied by these countries.

Although the rabies situation in Europe improved greatly during the last Century, the disease is still prevalent in wildlife in some EU member states and adjacent third countries. In areas where rabies occurs in wildlife a certain spill-over to domestic animals, including pets, may occur. It is therefore well justified that appropriate measures aimed at preventing pets from further spreading the disease are maintained as long as the disease persists in wildlife.Within EU the control of rabies in animals is based on a combination of national rules and Community legislation. The non-commercial movement of pets (dog, cat, ferrets) is governed by Regulation (EU) No 998/20031, establishing provisions for pet movement within the Community and from third countries into the EU. Article 6 of this Regulation provides that Ireland, UK, Sweden and Malta may maintain their national provisions for a transitional period of 5 years from the entry into force of this Regulation, i.e. until July 2008. These derogations consist of the requirement of an individual serological test for detection of neutralising rabies-antibodies and a waiting period before entry of pet animals into their territory.The Regulation further states that the derogations will be reviewed at the end of this transitory period of 5 years. To this end, the Commission has to submit to the European Parliament and to the Council, before the 1st of February 2007, a report on the need to maintain the serological test, and with appropriate proposals for determining the regime to be applied after this period. The report shall be based on the experience gained so far and on a risk analysis, following receipt of a scientific opinion of the European Food Safety Authority (EFSA).As a consequence, the Commission requested EFSA to issue a scientific opinion in order to assist in proposing appropriate amendments to the above Regulation. Specifically, the opinion should address to what extent abandoning the serological test could be envisaged without increasing the risk of introducing rabies and, if the need to maintain the serological test in certain circumstances is scientifically justified, what would be the appropriate regime/protocol giving equivalent assurances for the protection of these Member States against introduction of rabies.A number of countries have carried out independent rabies risk assessments in relation to pet movement. These assessments vary considerably in assumed control strategies and risk pathways and are therefore not directly comparable. They do, however, share most of the underlying parameter estimates used for modelling. To meet the terms of reference of the present assessment, it was judged necessary to develop risk pathways designed specifically to answer the questions raised, i.e. segregating the effect of testing from all other measures, using either established parameter estimates or modified according to available evidence.The risk of transmission of rabies by pet movement is related to moving an animal incubating disease. Pre-exposure vaccination of pets confers quick and almost complete protection to subsequent exposure by contact, e.g. bites. On the other hand, infection prior to vaccination cannot be controlled by immunisation but will require a quarantine and observation period covering the incubation period to be revealed. Previously, quarantine was implemented by physical isolation but with the advent of efficient vaccines, an "immunological quarantine" can be implemented with much less consequence for animal welfare.The unrestricted risk that a pet is incubating rabies at the time of primo-vaccination is equal to the prevalence of rabies-incubating pets in the population of origin. The prevalence can be estimated from the observed incidence of rabies in the population combined with an estimate of population size and the distribution of incubation times after natural infection. Following induction of protective immunity by vaccinating animal already incubating rabies will still develop clinical disease as a function of time after vaccination. Observing a vaccinated animal over a certain period will thus gradually reduce the risk ( termed type A in this opinion) that this animal incubates rabies, given that it has not developed clinical signs.Rabies vaccines are currently authorised on the basis of challenge tests in a target species and the measurement of protective levels of antibody. For monitoring the response to vaccination, the best available correlate with protection is to demonstrate that animals have achieved a serological titre of 0.5 IU/ml.As for any population of animals, a proportion may fail to mount an adequate serological response to vaccines and this may indicate that the individual animal may not be adequately protected against infection with the virus. If undetected, such animals may become infected after vaccination (termed type B risk in this opinion). The risk of the primo-vaccination with a single dose failing to induce an adequate serological response depends on the species, the age, the type of vaccine and the route and method of administration. Studies in published literature suggest that this risk can be effectively eliminated by administering a second vaccination at 4 to 6 weeks after the first, single vaccination thereby enhancing the chance that the desired antibody titre is achieved.However, such recommendations are not part of the currently approved immunisation schemes for most authorised products on the EU market where efficacy is ensured by rigorous challenge studies established by the European Pharmacopoeia.The overall risk reducing effect of applying a protocol including vaccination with or without testing and a specified waiting time has been modelled in a quantitative risk model. The major conclusions drawn from the study are:The primary means of protecting a pet from rabies in the population at risk is by vaccination. Inactivated rabies vaccines are highly efficient and induce rapid protective immunity that prevents infection and subsequent transmission of the disease.In quantitative terms, the type A risk constitutes by far the major risk. Therefore, a waiting time (defined as the time spent between vaccination and pet movement to the destined country), is the major effective measure to mitigate the risk of rabies introduction due to an animal being infected before primo-vaccination.The risk of infection following exposure during the waiting time (type B risk) depends on the protection induced by the vaccination in field conditions and becomes relatively more important as type A risk is reduced with extended waiting times (over 100 days). Serological testing can be used to identify seronegative pets and will therefore reduce this risk accordingly.Depending on the risk assessment model applied, a total risk reduction of 1.5 and 3.8, respectively, could be attributed to serological testing when the waiting time was 120 days. The same or an even better risk reduction can be obtained by replacing serological testing with a second vaccination 4 to 6 weeks after the first vaccination.For animals coming from countries with a negligible incidence of rabies, the best way to prevent rabies infection is simply by assuring adequate immunity after primo-vaccination before moving. In these countries, there is no rationale for including a waiting time beyond the time where protective immunity has been reached.The risk of transmitting rabies from populations where the annual incidence is below 1 in a million is considered negligible, even without applying a specific risk-mitigating protocol.Vaccination against rabies, using an authorised vaccine administered according to the approved vaccination schedule should remain the key requirement for pet movement between Member States. If further risk reduction is required, the protocol should include a waiting time following primo-vaccination and the length of waiting time should reflect the objective for risk reduction. The risk of having a certain proportion of pets vaccinated under field conditions that may not be fully protected can be reduced either by carrying out a serological test to measure antibodies or by administering a second injection of vaccine, provided that approved vaccination schedules are amended to include the option of administering a second injection where necessary.

EFSA has been requested by the European Commission for an assessment of the available scientific data on brucellosis diagnostic tests, and to issue a scientific opinion on the suitability of current and new tests for the diagnosis of brucellosis in bovines, sheep, and goats.At the Plenary Meeting of 25/26 May 2005, the AHAW Panel decided to entrust the collection and analysis of available data to a working group. A report on this task was given to the AHAW panel. The conclusions and recommendations were adopted at the Plenary Meeting on 11/12 December 2006.The Scientific Report reviewed all the available scientific data on Brucellosis diagnostic tests for bovines, sheep, and goats using a meta-analysis approach.Based on the data of a systematic literature review, meta-analytical estimates of the animallevel diagnostic sensitivity (Se) and specificity (Sp) for all new and standard tests, as well as the estimates of the difference for Se and Sp for all combination of tests, were obtained. Using an equivalence analysis approach, the null hypotheses that Se or Sp of a new brucellosis test are lower than the performance of standard tests were investigated. The Report elaborated on the importance of the negative predictive value and the Se with regard to safety in intra-Community trade and in addition explored the role of the Sp for the given purpose.For bovines the key conclusions and recommendations of the AHAW panel were:i) the following brucellosis diagnostic tests currently considered as standard tests in the EU legislation on intra-Community trade showed comparable Se and Sp and were found to be suitable for remaining as standard test: Rose Bengal Test (RBT), Complement Fixation Test (CFT), and Indirect Enzyme Linked Immunosorbent Assay (iELISA);ii) the Fluorescence Polarization Assay test (FPA) showed Se and Sp comparable to that of standard tests and was found to be suitable for inclusion in the EU legislation on intra-Community trade of bovines as standard test for brucellosis diagnosis;iii) the Radial Immunodiffusion Test with Native Hapten (RIDNH) showed lower Se and equal Sp comparable to that of standard tests and could be suitable for inclusion in the EU legislation on intra-Community trade as complementary test for brucellosis diagnosis;iv) for the Competition Enzyme Linked Immunosorbent Assay (cELISA), it is recommended that this type of test should remain in the EU legislation on intra-Community trade, where it is currently included as a complementary test, pending the conduct of further studies;v) the Serum Agglutination Test (SAT) showed lower Se and Sp compared to other standard tests and was not found to be suitable for remaining in the EU legislation on intra-Community trade. For sheep and goats the key conclusions and recommendations of the AHAW panel were:i) the two brucellosis diagnostic tests currently considered as standard tests in the EU legislation on intra-Community trade (RBT and CFT) showed comparable Se and Sp and were found suitable for remaining as standard tests;ii) the modified Rose Bengal Test (MRBT), the iELISA, the cELISA, the FPA, and the Brucellin Skin Test (BST) are suitable for inclusion in the EU legislation on intra- Community trade because their Se was equal to that of standard tests. However, with the exception of the BST, these tests have Sp lower to the standard tests or their Sp is not sufficiently documented. Thus, when using Se and Sp as criteria for assessing the fitness for the purpose of intra-Community trade, the AHAW Panel concludes that these tests, except BST, are not suitable for inclusion in the EU legislation on intra- Community trade of sheep and goats unless new data demonstrate that these tests are at least as specific as the standard tests.iii) the RIDNH is not suitable for inclusion in the EU legislation on intra- Community trade because its Se was lower compared to that of standard tests. It can be pointed out that this test has equal Sp compared to standard tests.

The current distribution of bluetongue (BT) in Europe deserves special consideration in regard to i) the spread and epidemiology of BT virus (BTV) into new regions, ii) the surveillance and monitoring activities of MSs, iii) the clinical and laboratory diagnosis of BT, iv) a scientific approach being adopted in the use of vaccines against BTV, and v) possible control of the Culicoides vectors implicated in the spread of all BTVs.BTV serotype 8 affected five countries in Northern Europe whereas other serotypes (BTV-1, -2, -4, -9 and -16) had been responsible for the recent and multiple outbreaks of BT in parts of Southern Europe.In regard to the epidemiological follow-up of the serotype 8 outbreak, in Northern Europe the EFSA epidemiological working group is in the process of conducting a global analysis. In regard to surveillance, monitoring, and the laboratory diagnosis of BT, a harmonised community-based approach has already been introduced with the result that the community Central Reference Laboratory (CRL) has prepared a draft document and which was sent to all CVOs in September 2006.The Commission required further scientific opinions on the i) the role of vectors in the transmission of BTV and the means to control them; ii) the most recent developments, and experience gained, in the use of different vaccines against BT in sheep, cattle and goats; iii) the scientific assessment of the vaccination campaigns conducted against BTV in Member States, and iv) the suitability of vaccination as a tool of choice to control BT and, in addition, as tool to facilitate also the safe trade in different livestock species. In order to reply to this mandate a working group was established by the AHAW Panel.In regard to their role in the transmission of diseases and the means to control them, Culicoides constitute a numerous and widespread group and act as important vectors of many pathogens including BTV. The knowledge of the life cycle of most species of Culicoides in Northern Europe remains incomplete. Nevertheless, it has always been known that Culicoides overwinter in the larval stage, but recent findings in the MSs show that there is now almost continuous emergence of fresh adult midges through the winter at the northern latitudes affected by BTV. Multiple blood feeding events by Culicoides are crucial to the initiation and subsequent spread of BTV. There is strong circumstantial evidence to suggest that though the normal flight range of Culicoides is short, they are also able to travel much longer distances (>100 km) and so may be able to introduce pathogens like BTV into regions remote from the source. The efficiency with which vector species transmit BTV varies according to their susceptibility, biting and survival rates, the virus serotype and the ambient temperature. Although the infection rate in vectors is generally low, transmission from a viraemic host to the vector is much less than the oposite (vectors to animals). However, high biting rates in the field tend to compensate for this. Although Culicoides may be active at temperatures of around 10 degrees C, virus replication in the insect begins to proceed at 15-18 degrees C. The optimal temperature for BTV transmission probably lies in the range of 27-30 degrees C since then most vectors survive long enough to transmit at least once and the virus replication rate is maximal.The precise levels of protection provided by insecticide treatment and housing of stock is unclear and neither are likely to eliminate the risk of BTV transmission. However, insecticides treatments could provide some measure of protection. Insecticides treatment should thus be included in a set of measures designed to decrease biting midge densities; however, the supposed impact of such measures on the rate of BTV transmission has yet to be quantified in the European context and should therefore be used as a risk mitigation measure in certain circumstances (e.g. breeding animals, trade or in recently infected farms).The biological properties of inactivated vaccines and modified live virus vaccines (MLV) are described in detail based upon data received from various manufacturers and upon data obtained during experimental trials and from their in-field use. It can be concluded that all BTV inactivated vaccines, when administered in two separate doses, are able to fully protect animals for a long period. However, a single dose of BTV-4 inactivated vaccine only partially reduced viraemia in cattle when challenged 7 months later. Numerous MLV vaccines have been used under a wide range of conditions in the field. All were found to induce viremia allowing for the potential infection, and possible subsequent transmission, of MLV strains of BTV by insects; furthermore, the magnitude and duration of viremia in animals uninfected and vaccinated with MLVs remains to be determined for most of these vaccines. Viremia in sheep vaccinated with MLV strains of BTV-2, -4, -9 and -16 (including multivalent constructs) persisted for up to 24 days whereas in cattle viraemia persisted for up to 78 days. Statistical analyses of the data available on the levels of viraemia reported in cattle and sheep, after they had been vaccinated with BTV-2 and -9 MLVs, indicated cattle and sheep could be moved at 32 and 28 days, respectively. However, a low level (<0.01%) of risk of transmission, remains for ruminants, vaccinated in infected areas, when infection with field strains, just prior to or at the moment of vaccination. Thus in infected areas, to minimise the risk of the infection being spread, a waiting period of at least 60 days is required before animals can be moved.In general, the use of vaccines which prevent viraemia after challenge is recommended. In the case that inactivated vaccines are available such vaccines should be used in preference. The use of MLVs can be considered only after a comprehensive risk/benefit analysis has been made. Ideally, and for the purpose of eradication, a comprehensive vaccination campaign should include all susceptible ruminant species.Vaccines are suitable for the control of the infection in endemic/epizootic areas. Vaccination, preferably using an inactivated virus, is recommended as a first line of defence but within a set of measures including mainly animal movement control and Culicoides control. To facilitate the availability of authorized Bluetongue vaccines a similar approach could be followed to the one that was recently applied for Avian Influenza vaccines.To protect southern countries in the EU, preventive vaccination with inactivated vaccines targeted to the serotypes circulating in neighbouring countries outside the EU should be considered to be used in the highest risk areas of free countries on a risk/benefit analysis, when the introduction of BTV by the wind is considered as highly probable.In general to reduce the risk of introduction of BTV to southern countries in the EU, systematic vaccination in the endemically affected EU neighbouring countries around the Mediterranean basin should be encouraged.The vaccines are also suitable tools to facilitate the safety of movements of animals in infected areas when several factors are taken into consideration such as: the period of implementation of the vaccination, the vector activity period, the prevalence of the infection, etc. The vaccines used should be authorized by the competent authority (by following, if needed, the emergency procedures) by the competent authorities which, in consequence, will be in a position to check if the manufacturers complies with the GMP and control tests to be carried out as defined in the CVMP guidelines and general E.P. monographs. Wherever possible, a centralised procedure is preferable to allow a better exchange of the data available between MS.Current pharmaceutical legislation does not cover the assessment and authorization of diagnostic tests, even when such tests are an essential component of the use of a 'marker' vaccine in a DIVA (differentiation of vaccination from infection) vaccination campaign.The circulation of BTV in wild ruminants can compromise a vaccination campaign and for this reason it is essential to establish what their precise role might be in the epidemiology of the disease.

Regulation (EC) No 998/20031 lays down the rules for the non-commercial movements of pet animals (dog, cat, ferrets) both within the community as well as from third countries into the EU. The United Kingdom, Ireland and Malta have maintained their national rules as regards the control of echinococcosis and ticks, while Sweden and Finland have maintained their national rules as regards the control of echinococcosis. The derogations will be reviewed at the end of a transitional period of 5 years, on the basis of a report on the need to maintain such additional requirements. This opinion addresses the risk of introduction of Echinococcus multilocularis into free MS, by pet movements, if the treatment in place is abandoned.The principal definitive hosts for E. multilocularis are canids consuming rodents as prey, e.g. foxes (Vulpes spp., Alopex lagopus) and coyotes (Canis latrans). The metacestodes of E. multilocularis are adapted to small rodents (usually species of Arvicolidae). Human beings can become accidentally infected (dead-end host) by ingesting tapeworm eggs excreted by the final hosts. The resulting disease, alveolar echinococcosis (AE) typically presents as an infiltrative tumour-like growth in the liver, with a poor prognosis. Domestic dogs and cats can also be infected by the worms, although with a low prevalence.The parasite is found in foxes in central Europe, from the north to Denmark, the Netherlands and Belgium, in the east to the Baltic States and Slovakia, in the south to north eastern Italy and Hungary, and in the west to central France. There is evidence of an increase in the parasite density in many areas, probably correlated to an increase in the fox population. Also, foxes have adapted to urban environments. Infection of domestic carnivores by E. multilocularis appears to be a rare event, but may, however, play a key role in transmission to humans due to close contact. Very few studies exist on prevalence of E. multilocularis in domestic carnivores. The low infection rates in domestic dogs in Europe are most likely due to low exposure to the parasite and to routine worming of domestic pets. In humans, data point to an apparent increase of AE cases.Praziquantel and Epsiprantel may be used for effective treatment of E. multilocularis infection in definitive hosts. Both are safe and well tolerated in dogs and cats. However, none of these products is ovicidal. Parasiticidal effect is short lived ( around 24 hours), allowing for re-infection after treatment. Also, due to the lack of ovicidal activity, infected pets treated with Praziquantel may shed infectious tapeworm eggs for several hours after treatment.There are very few data on the prevalence or incidence of infections with E. multilocularis in pets, in particular in pets to be moved into an area considered free of this parasite. Therefore it was considered that the risk assessment should be qualitative.From the RA it was concluded that the risk of dogs and cats to become infected with E. multilocularis as final hosts in endemic areas is greater than negligible. The regional prevalence in wildlife and access to intermediate hosts influence the infection risk of pets and dogs. Therefore, a proportion of dogs and cats to be moved from an endemic area into a country considered free of E. multilocularis will be infected, and the abandoning of additional measures will increase the risk of introducing the parasite into an area considered free of E. multilocularis.From the three current treatment protocols used by the UK, Republic of Ireland, Malta, Finland and Sweden it was concluded that the probability of re-infection in the country of origin, and the probability of viable egg elimination in the importing country is reduced to a negligible level when a suitable treatment with Praziquantel is given between 24 and 48hours prior to departure...

SUMMARY Following a request from the European Commission (DG Health and Consumer Protection), the Panel on Animal Health and Welfare (AHAW) was requested for an opinion on porcine brucellosis (Brucella suis). B. suis consists of five biovars, however infection in pigs is caused by the first three biovars (biovars 1, 2, and 3). Infection of animals caused by biovars 1 and 3 differs from that caused by biovar 2 in the host specificity and geographical distribution. In the context of public health, biovar 2 is very rarely pathogenic for humans, whereas biovars 1 and 3 are highly pathogenic causing severe disease in human beings. There is currently no requirement for monitoring and surveillance of B. suis in domestic pigs or in wild life and therefore a lack of systematic epidemiologic data on porcine brucellosis in most MS. The occurrence of the disease is mainly sporadic (with the exception of certain areas where the characteristics of the production systems allow B. suis to be endemic). Within the EU, the epidemiological situation is varied, with some countries free of the disease, others reporting sporadic outbreaks and yet others reporting this disease as an emergent problem. Available epidemiological evidence shows that B. suis biovar 2 is the most common agent, but biovars 1 and 3 can also occur. Available evidence also suggests that currently the wild boar seems to remain the main source of infection for domestic pigs because several outbreaks of B. suis occurred in outdoor rearing systems, even on fenced premises, with the source of infection traced to contacts with wild boars. Transmission from wild boars to pigs is thought to be through the venereal route, as 1 For citation purposes: Scientific Opinion of the Panel on Animal Health and Welfare (AHAW) on a request from the

The Animal Health and Welfare panel of EFSA was invited by the European Commission to issue a scientific opinion on the risk of feeding farmed animals with ready-to-use Category 3 milk, milk-based products and milk-derived products, and raw products produced to food standard under Regulation (EC) No 853/2004, without further treatment as stated in the ABP regulation (EC) 1774/2002).The mandate given by the EC covers two aspects, namely the risks caused by the use of the dairy by-products of concern to animal health and of concern to public health. Therefore, EFSA decided to produce two different opinions, one from the Animal Health and Animal Welfare panel (AHAW) and one from the panel for Biological Hazards (BIOHAZ).The first part of the Scientific Report describes the structure of dairy production and processing of milk with special reference to thermal and other processes applied to reduce human and animal exposure to biological hazards. In addition, the dairy products of concern, their rejection and the practices used for feeding animals with the products are also described. Milk from cow, sheep, goat and buffalo are considered. The second part of the Scientific Report identifies, as the principal hazards, 24 infectious diseases of animals, of which 5 can also infect humans (zoonoses), all of which were subjected to a qualitative risk assessment. A quantitative risk assessment was also done for the risk of transmission of Foot and Mouth Disease (FMD) as it is one of the main concerns.The assessment demonstrated a significant risk for the transmission of the infectious animal diseases studied including zoonoses through feeding farmed animals with different kinds of ready-to-use Category 3 milk, milk-based products and milk-derived products, as well as raw products produced to the food standard under Regulation (EC) No 853/2004 without further treatment.Both the qualitative and quantitative risk assessments demonstrated that the risk of spreading FMD with milk and milk products are substantial if FMD is introduced unnoticed, and if products are not subjected to a combination of treatments that eliminate the risk. The risk under consideration is estimated to be moderate to high for five products: i) raw milk; ii) non-heat treated white water; iii) unpasteurised cheese with a pH> 6 during the processing; iv) butter when made from pasteurized cream; and v) whey made from raw milk during cheese processing.It was highlighted that raw milk as well other dairy by-products are often transported between Member States to feed to animals and consequently, outbreaks of disease can occur far away from the collecting area of the by-products including raw milk.Raw milk and raw milk products constituted the highest risk and it was noted that a few Member States legally allow humans to consume raw milk. It is also noteworthy that many sheep and goat cheeses are made from raw milk in the Mediterranean regions in Southern Europe.The processing standards according to the provisional measures (EC 79/2005; Chapter 2.3.2) for Category 3 Dairy Products such as processed products, whey, unprocessed products and white water, are less strict than the standards in the ABP Regulation, and do not prevent the risks of exposure and transmission of diseases to farmed animals through the feeding of such products.Dairy by-products containing raw milk, white water or unpasteurised dairy products should not be used for feeding farmed animals to avoid the risk of transmission of infectious diseases. No dairy by-products should be fed to animals unless they have been appropriately treated so as to avoid the risk of transmission of infectious diseases, including FMD and MAP.The full traceability of dairy products should be ensured if heat-treated dairy by-products are to be used for feeding animals (see Recommendation 2). Traceability systems should be in the form of records of the quantities of material despatched, the nature of the materials, their destination, and any mixing of products and batches.In conclusion, actions such as those set out in the standards of the ABP Regulations should be taken to avoid the risk of spreading infectious diseases through the feeding of Category 3 dairy products

A qualitative risk assessment was conducted to determine 1) the likelihood of introduction of Asian lineage H5N1 highly pathogenic avian influenza virus by migratory birds into the EU, 2) the likelihood of it becoming endemic in wild birds in the EU and 3) the likelihood of transmission of infection to domestic poultry. The conclusions reached included that the probability of the virus being released into the EU varied between low and high, depending on the species of migratory birds. A minority opinion was noted concluding that the risk was medium across species. In the light of this risk, it was recommended to educate poultry keepers in currently affected countries outside the EU in relation to minimum biosecurity standards. Surveillance should be enhanced in these countries in domestic poultry and wild birds, and vaccination programmes should be considered for controlling the infection. Trade with poultry and their products needs to be managed considering the risks of spreading virus between geographical areas. Research needs to be conducted to improve surveillance methods in poultry and widl birds. Wild bird migration data needs to be analysed to better understand the flyways used by the various species.The risk of the virus becoming endemic in European wild bird populations was considered to vary between low and high depending on species. A minority opinion was received concluding that this risk was medium across species. This risk could be reduced by intensifying surveillance in wild birds within the EU, and use the data to inform biosecurity measures in domestic birds. The behaviour of wild birds within the EU needs to be better studied so that the dynamics of transmission within and between species are better understood.The final step of the risk assessment indicates that there is a negligible risk of the virus infecting domestic poultry kept under a high biosecurity standard and not in high poultry density areas. The risk increases to very low if they are kept in high poultry density areas. For backyard and free-range poultry, and any poultry not kept under high biosecurity standards, it was concluded that the risk of introduction of Asian lineage H5N1 highly pathogenic avian influenza virus to the flock was low to medium. These risks emphasize the need to make better use of existing and new migratory bird behaviour data. Passive and active surveillance for AI in wild birds needs to be intensified. It should focus on the species identified in this risk assessment. Biosecurity measures for poultry holdings need to be reviewed, and research needs to be conducted to optimise their effectiveness. Poultry holdings should not be built in the vicinity of wetland areas. New vaccines and their use need to be researched.